,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,32342857,Two speeds of increasing milk feeds for very preterm or very low-birthweight infants: the SIFT RCT.,"BACKGROUND


Observational data suggest that slowly advancing enteral feeds in preterm infants may reduce necrotising enterocolitis but increase late-onset sepsis. The Speed of Increasing milk Feeds Trial (SIFT) compared two rates of feed advancement.
OBJECTIVE


To determine if faster (30 ml/kg/day) or slower (18 ml/kg/day) daily feed increments improve survival without moderate or severe disability and other morbidities in very preterm or very low-birthweight infants.
DESIGN


This was a multicentre, two-arm, parallel-group, randomised controlled trial. Randomisation was via a web-hosted minimisation algorithm. It was not possible to safely and completely blind caregivers and parents.
SETTING


The setting was 55 UK neonatal units, from May 2013 to June 2015.
PARTICIPANTS


The participants were infants born at < 32 weeks' gestation or a weight of < 1500 g, who were receiving < 30 ml/kg/day of milk at trial enrolment.
INTERVENTIONS


When clinicians were ready to start advancing feed volumes, the infant was randomised to receive daily feed increments of either 30 ml/kg/day or 18 ml/kg/day. In total, 1400 infants were allocated to fast feeds and 1404 infants were allocated to slow feeds.
MAIN OUTCOME MEASURES


The primary outcome was survival without moderate or severe neurodevelopmental disability at 24 months of age, corrected for gestational age. The secondary outcomes were mortality; moderate or severe neurodevelopmental disability at 24 months corrected for gestational age; death before discharge home; microbiologically confirmed or clinically suspected late-onset sepsis; necrotising enterocolitis (Bell's stage 2 or 3); time taken to reach full milk feeds (tolerating 150 ml/kg/day for 3 consecutive days); growth from birth to discharge; duration of parenteral feeding; time in intensive care; duration of hospital stay; diagnosis of cerebral palsy by a doctor or other health professional; and individual components of the definition of moderate or severe neurodevelopmental disability.
RESULTS


The results showed that survival without moderate or severe neurodevelopmental disability at 24 months occurred in 802 out of 1224 (65.5%) infants allocated to faster increments and 848 out of 1246 (68.1%) infants allocated to slower increments (adjusted risk ratio 0.96, 95% confidence interval 0.92 to 1.01). There was no significant difference between groups in the risk of the individual components of the primary outcome or in the important hospital outcomes: late-onset sepsis (adjusted risk ratio 0.96, 95% confidence interval 0.86 to 1.07) or necrotising enterocolitis (adjusted risk ratio 0.88, 95% confidence interval 0.68 to 1.16). Cost-consequence analysis showed that the faster feed increment rate was less costly but also less effective than the slower rate in terms of achieving the primary outcome, so was therefore found to not be cost-effective. Four unexpected serious adverse events were reported, two in each group. None was assessed as being causally related to the intervention.
LIMITATIONS


The study could not be blinded, so care may have been affected by knowledge of allocation. Although well powered for comparisons of all infants, subgroup comparisons were underpowered.
CONCLUSIONS


No clear advantage was identified for the important outcomes in very preterm or very low-birthweight infants when milk feeds were advanced in daily volume increments of 30 ml/kg/day or 18 ml/kg/day. In terms of future work, the interaction of different milk types with increments merits further examination, as may different increments in infants at the extremes of gestation or birthweight.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN76463425.
FUNDING


This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 18. See the NIHR Journals Library website for further project information.",2020,"There was no significant difference between groups in the risk of the individual components of the primary outcome or in the important hospital outcomes: late-onset sepsis (adjusted risk ratio 0.96, 95% confidence interval 0.86 to 1.07) or necrotising enterocolitis (adjusted risk ratio 0.88, 95% confidence interval 0.68 to 1.16).","[""The participants were infants born at <\u200932 weeks' gestation or a weight of <\u20091500\u2009g, who were receiving <\u200930\u2009ml/kg/day of milk at trial enrolment"", 'very preterm or very low-birthweight infants', '1400 infants were allocated to fast feeds and 1404 infants', 'preterm infants']",[],"['mortality; moderate or severe neurodevelopmental disability', ""gestational age; death before discharge home; microbiologically confirmed or clinically suspected late-onset sepsis; necrotising enterocolitis (Bell's stage 2 or 3); time taken to reach full milk feeds"", 'important hospital outcomes: late-onset sepsis', 'survival without moderate or severe neurodevelopmental disability', 'survival without moderate or severe disability and other morbidities', 'serious adverse events', 'necrotising enterocolitis', 'hospital stay; diagnosis of cerebral palsy by a doctor or other health professional; and individual components of the definition of moderate or severe neurodevelopmental disability']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C1532579', 'cui_str': 'mL/kg/day'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C3539107', 'cui_str': 'Definition'}]",1400.0,0.368289,"There was no significant difference between groups in the risk of the individual components of the primary outcome or in the important hospital outcomes: late-onset sepsis (adjusted risk ratio 0.96, 95% confidence interval 0.86 to 1.07) or necrotising enterocolitis (adjusted risk ratio 0.88, 95% confidence interval 0.68 to 1.16).","[{'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Dorling', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, Faculty of Medicine, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Hewer', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Hurd', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Vasha', 'Initials': 'V', 'LastName': 'Bari', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Bosiak', 'Affiliation': ""Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Bowler', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'King', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Linsell', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Murray', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Omar', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Partlett', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Rounding', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Townend', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Abbott', 'Affiliation': 'Bliss, London, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Berrington', 'Affiliation': 'Newcastle Neonatal Service, Royal Victoria Infirmary, Newcastle upon Tyne, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Boyle', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Embleton', 'Affiliation': 'Newcastle Neonatal Service, Royal Victoria Infirmary, Newcastle upon Tyne, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Leaf', 'Affiliation': 'National Institute for Health Research Southampton Biomedical Research Centre Department of Child Health, University of Southampton, Southampton, UK.'}, {'ForeName': 'Kenny', 'Initials': 'K', 'LastName': 'McCormick', 'Affiliation': 'John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'McGuire', 'Affiliation': 'Centre for Reviews and Dissemination, University of York, York, UK.'}, {'ForeName': 'Mehali', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Bliss, London, UK.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Roberts', 'Affiliation': 'School of Health and Population Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Stenson', 'Affiliation': 'The Simpson Centre for Reproductive Health, Royal Infirmary of Edinburgh, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Warda', 'Initials': 'W', 'LastName': 'Tahir', 'Affiliation': 'School of Health and Population Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Monahan', 'Affiliation': 'School of Health and Population Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Richards', 'Affiliation': 'Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Rankin', 'Affiliation': 'Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Juszczak', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24180']
1,32339032,SAFETY AND EFFICACY OF DDP4-INHIBITORS FOR MANAGEMENT OF HOSPITALIZED GENERAL MEDICINE AND SURGERY PATIENTS WITH TYPE 2 DIABETES.,"Background:  DPP4-inhibitors (DPP4-i) have been shown to be effective for the management of inpatient diabetes. We report pooled data from three prospective studies using DPP4-i in general medicine and surgery patients with type 2 diabetes (T2D).  Research Design and Methods:  We combined data from three randomized studies comparing DPP4-i alone or in combination with basal insulin or basal bolus insulin regimen. Medicine (n=266) and surgery (n=319) patients admitted with a blood glucose (BG) between 140 and 400 mg/dl, treated with diet, oral agents or low-dose insulin therapy were included. Patients received DPP4-i alone (n=144), DPP4-i plus basal insulin (n=158) or basal bolus regimen (n=283). All groups received correctional doses with rapid-acting insulin for BG >140mg/dl. The primary endpoint was differences in mean daily BG between groups. Secondary endpoints included differences in hypoglycemia and hospital complications.  Results:  There were no differences in mean hospital daily BG among patients treated with DPP4-i alone (170±37 mg/dl), DPP4-i plus basal (172±42 mg/dl) or basal bolus (172±43 mg/dl), p=0.94; or in the percentage of BG readings within target of 70-180 mg/dl (63±32%, 60±31% and 64±28% respectively, p=0.42). There were no differences in length of stay or complications, but hypoglycemia was less common with DPP4-i alone (2%) compared to DPP4-i plus basal (9%) and basal bolus (10%), p=0.004.  Conclusion:  Treatment with DPP4-i alone or in combination with basal insulin is effective and results in lower incidence of hypoglycemia compared to a basal bolus insulin re gimen in general medicine and surgery patients with T2D.",2020,is effective and results in lower incidence of hypoglycemia compared to a basal bolus insulin,"['general medicine and surgery patients with T2D', 'general medicine and surgery patients with type 2 diabetes (T2D', 'n=266) and surgery (n=319) patients admitted with a blood glucose (BG) between 140 and 400 mg/dl, treated with']","['DPP4-i alone', 'correctional doses with rapid-acting insulin for BG >140mg/dl', 'DPP4-i alone or in combination with basal insulin or basal bolus insulin regimen', ':  DPP4-inhibitors (DPP4-i', 'diet, oral agents or low-dose insulin therapy', 'DPP4-i plus basal insulin (n=158) or basal bolus regimen', 'DPP4-i', 'DPP4-i alone or in combination with basal insulin', 'Medicine']","['hypoglycemia and hospital complications', 'mean daily BG', 'mean hospital daily BG', 'length of stay or complications, but hypoglycemia', 'hypoglycemia']","[{'cui': 'C0086343', 'cui_str': 'General medicine'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0356365', 'cui_str': 'Short-acting insulin'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.0952002,is effective and results in lower incidence of hypoglycemia compared to a basal bolus insulin,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Lorenzo-González', 'Affiliation': 'From: Department of Endocrinology and Nutrition, Hospital Universitario Nuestra Señora de La Candelaria, Tenerife, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Atienza-Sánchez', 'Affiliation': 'Department of Endocrinology and Nutrition, Hospital Universitario Príncipe de Asturias, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reyes-Umpierrez', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Priyathama', 'Initials': 'P', 'LastName': 'Vellanki', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Georgia M', 'Initials': 'GM', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Pasquel', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Saumeth', 'Initials': 'S', 'LastName': 'Cardona', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Fayfman', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Schoolf of Public Health, Emory University.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.4158/EP-2019-0481']
2,32339370,Histology of augmented autogenous bone covered by a platelet-rich fibrin membrane or deproteinized bovine bone mineral and a collagen membrane: A pilot randomized controlled trial.,"OBJECTIVES


This study aimed to evaluate histologic and histomorphometric bone characteristics with a focus on vitality after lateral alveolar ridge augmentation using an autogenous bone graft as a block covered by either a platelet-rich fibrin (PRF) membrane (test group) or a standard procedure involving coverage of the bone block with a deproteinized bovine bone mineral and a resorbable collagen membrane (control group).
MATERIAL AND METHODS


A total of 27 (test = 14, control = 13) partially edentulous patients with indication for bone block augmentation before implant installation were included. For analyses, a biopsy of augmented bone was retrieved six months after bone grafting.
RESULTS


Histologic evaluation of augmented bone revealed a predominance of non-vital bone toward the periosteum and few localized areas of vital bone in the center of the graft in both groups. In contrast, augmented bone toward the native bone demonstrated extensive bone remodeling in both groups. Histomorphometric analyses demonstrated a mean of 14% vital bone, 80% non-vital bone, 5% soft tissue, and 1% blood vessels in the test group. In the control group, the corresponding shares were 14% vital bone, 63% non-vital bone, 22% soft tissue, and 1% blood vessels. We observed no significant differences between the groups (p > .05).
CONCLUSION


In conclusion, a comparable low bone vitality of augmented bone was observed in the PRF and in the control group. Consequently, the present study could not verify the potential beneficial effect of a PRF membrane on bone vitality of an autogenous bone graft used as a block.",2020,"RESULTS


Histologic evaluation of augmented bone revealed a predominance of non-vital bone towards the periosteum and few localized areas of vital bone in the center of the graft in both groups.","['A total of 27 (test = 14, control = 13) partially edentulous patients with indication for bone block augmentation before implant installation were included']","['PRF membrane', 'platelet-rich fibrin (PRF) membrane (test group) or a standard procedure involving coverage of the bone block with a deproteinized bovine bone mineral and a resorbable collagen membrane (control group', 'platelet-rich fibrin membrane or deproteinized bovine bone mineral and a collagen membrane']","['bone vitality', 'low bone vitality of augmented bone']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1293164', 'cui_str': 'Bone block procedure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1293164', 'cui_str': 'Bone block procedure'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",80.0,0.0407757,"RESULTS


Histologic evaluation of augmented bone revealed a predominance of non-vital bone towards the periosteum and few localized areas of vital bone in the center of the graft in both groups.","[{'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Hartlev', 'Affiliation': 'Department of Dentistry and Oral Health, Section for Oral Surgery and Oral Pathology, Aarhus University, Aarhus C, Denmark.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Erik Nørholt', 'Affiliation': 'Department of Dentistry and Oral Health, Section for Oral Surgery and Oral Pathology, Aarhus University, Aarhus C, Denmark.'}, {'ForeName': 'Rubens', 'Initials': 'R', 'LastName': 'Spin-Neto', 'Affiliation': 'Department of Dentistry and Oral Health, Section for Oral Radiology, Aarhus University, Aarhus C, Denmark.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kraft', 'Affiliation': 'Department of Dentistry and Oral Health, Section of Orthodontics, Aarhus University, Aarhus C, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Schou', 'Affiliation': 'Faculty of Health Sciences, Department of Periodontology, School of Dentistry, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Flemming', 'Initials': 'F', 'LastName': 'Isidor', 'Affiliation': 'Department of Dentistry and Oral Health, Section for Prosthetic Dentistry, Aarhus University, Aarhus C, Denmark.'}]",Clinical oral implants research,['10.1111/clr.13605']
3,32339499,"Effects of exogenous ghrelin administration and ghrelin receptor blockade, in combination with alcohol, on peripheral inflammatory markers in heavy-drinking individuals: Results from two human laboratory studies.","The ghrelin system has been garnering interest for its role in different neuropsychiatric disorders, including alcohol use disorder (AUD). Accordingly, targeting the ghrelin system is under investigation as a potential novel therapeutic approach. While alcohol provokes the immune system and inflammatory responses, ghrelin has potent immunomodulatory and anti-inflammatory properties. The present study aimed to shed light on the ""crosstalk"" between ghrelin and inflammation by examining the effects of exogenous ghrelin administration and ghrelin receptor blockade on peripheral inflammatory markers in the context of two human laboratory studies with alcohol administration. Non-treatment-seeking, heavy-drinking individuals with alcohol dependence, the majority of whom were African American males, were enrolled. In the first randomized, crossover, double-blind, placebo-controlled human laboratory study, participants underwent two experimental paradigms - an intravenous alcohol self-administration (IV-ASA) and an intravenous alcohol clamp (IV-AC) - each consisting of two counterbalanced sessions (ghrelin, placebo). A loading dose of intravenous ghrelin (3 mcg/kg) or placebo, followed by a continuous ghrelin (16.9 ng/kg/min) or placebo infusion was administered. In the second dose-escalating, single-blind, placebo-controlled human laboratory phase 1b study, participants were dosed with an oral ghrelin receptor blocker (PF-5190457) and underwent an oral alcohol challenge. Repeated blood samples were collected, and plasma concentrations of the following inflammatory markers were measured: C-reactive protein (CRP), interleukin (IL)-6, IL-10, IL-18, and tumor necrosis factor alpha (TNF-α). During the IV-ASA experiment, significant drug × time interaction effects were observed for IL-6 (F 3,36  = 3.345, p = 0.030) and IL-10 (F 3,53.2  = 4.638, p = 0.006), indicating that ghrelin, compared to placebo, significantly reduced blood concentrations of the proinflammatory cytokine IL-6, while increasing blood concentrations of the anti-inflammatory cytokine IL-10. No significant drug × time interaction effects were observed during the IV-AC experiment, possibly because of its much shorter duration and/or smaller sample. Treatment with PF-5190457, compared to placebo, had no significant effect on the inflammatory markers investigated. In conclusion, a supraphysiologic pharmacological challenge with exogenous ghrelin in heavy-drinking individuals produced anti-inflammatory effects in the context of intravenous alcohol administration. On the contrary, ghrelin receptor blockade did not lead to any change in the inflammatory markers included in this study. Mechanistic studies are required to better understand the interaction between ghrelin, alcohol, and inflammatory processes.",2020,"(F 3,36  = 3.345, p = 0.030) and IL-10 (F 3,53.2  = 4.638, p = 0.006), indicating that ghrelin, compared to placebo, significantly reduced blood concentrations of the proinflammatory cytokine IL-6, while increasing blood concentrations of the anti-inflammatory cytokine IL-10.","['heavy-drinking individuals', 'two human laboratory studies with alcohol administration. Non-treatment-seeking, heavy-drinking individuals with alcohol dependence, the majority of whom were African American males']","['PF-5190457', 'oral ghrelin receptor blocker (PF-5190457) and underwent an oral alcohol challenge', 'intravenous alcohol self-administration (IV-ASA) and an intravenous alcohol clamp (IV-AC) - each consisting of two counterbalanced sessions (ghrelin, placebo', 'placebo', 'exogenous ghrelin administration and ghrelin receptor blockade', 'intravenous ghrelin']","['blood concentrations of the anti-inflammatory cytokine IL-10', 'IL-6', 'C-reactive protein (CRP), interleukin (IL)-6, IL-10, IL-18, and tumor necrosis factor alpha (TNF-α', 'time interaction effects', 'IL-10', 'blood concentrations of the proinflammatory cytokine IL-6']","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C4279098', 'cui_str': 'PF-5190457'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0391690', 'cui_str': 'Growth Hormone Secretagogue Receptor'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.168388,"(F 3,36  = 3.345, p = 0.030) and IL-10 (F 3,53.2  = 4.638, p = 0.006), indicating that ghrelin, compared to placebo, significantly reduced blood concentrations of the proinflammatory cytokine IL-6, while increasing blood concentrations of the anti-inflammatory cytokine IL-10.","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Farokhnia', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States; Center on Compulsive Behaviors, National Institutes of Health, Bethesda, MD, United States; Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Jeanelle', 'Initials': 'J', 'LastName': 'Portelli', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Lee', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States.'}, {'ForeName': 'Gray R', 'Initials': 'GR', 'LastName': 'McDiarmid', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Munjal', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States.'}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Abshire', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States.'}, {'ForeName': 'Jillian T', 'Initials': 'JT', 'LastName': 'Battista', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States.'}, {'ForeName': 'Brittney D', 'Initials': 'BD', 'LastName': 'Browning', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States.'}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Deschaine', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Akhlaghi', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, United States.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Leggio', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States; Center on Compulsive Behaviors, National Institutes of Health, Bethesda, MD, United States; Medication Development Program, National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Baltimore, MD, United States; Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University, Providence, RI, United States. Electronic address: lorenzo.leggio@nih.gov.'}]",Brain research,['10.1016/j.brainres.2020.146851']
4,32339648,Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma.,"BACKGROUND


The phase 3 JAVELIN Renal 101 trial (NCT02684006) demonstrated significantly improved progression-free survival (PFS) with first-line avelumab plus axitinib vs sunitinib in advanced renal cell carcinoma (aRCC). We report updated efficacy data from the second interim analysis.
PATIENTS AND METHODS


Treatment-naïve patients with aRCC were randomized (1:1) to receive avelumab (10 mg/kg) intravenously every 2 weeks plus axitinib (5 mg) orally twice daily or sunitinib (50 mg) orally once daily for 4 weeks (6-week cycle). The two independent primary endpoints were PFS and overall survival (OS) among patients with PD-L1+ tumors. Key secondary endpoints were OS and PFS in the overall population.
RESULTS


Of 886 patients, 442 were randomized to the avelumab plus axitinib arm and 444 to the sunitinib arm; 270 and 290 had PD-L1+ tumors, respectively. After a minimum follow-up of 13 months (data cutoff Jan 28, 2019), PFS was significantly longer in the avelumab plus axitinib arm than in the sunitinib arm (PD-L1+ population: hazard ratio [HR] 0.62 [95% CI, 0.490-0.777]; 1-sided P < 0.0001; median 13.8 [95% CI, 10.1-20.7] vs 7.0 months [95% CI, 5.7-9.6]; overall population: HR 0.69 [95% CI, 0.574-0.825]; 1-sided P < 0.0001; median 13.3 [95% CI, 11.1-15.3] vs 8.0 months [95% CI, 6.7-9.8]). OS data were immature (PD-L1+ population: HR 0.828 [95% CI, 0.596-1.151]; 1-sided P = 0.1301; overall population: HR 0.796 [95% CI, 0.616-1.027]; 1-sided P = 0.0392).
CONCLUSION


Among patients with previously untreated aRCC, treatment with avelumab plus axitinib continued to result in a statistically significant improvement in PFS vs sunitinib; OS data were still immature.",2020,OS data were immature (PD-L1+ population: HR 0.828,"['886 patients', 'advanced renal cell carcinoma (aRCC', 'patients with advanced renal cell carcinoma', 'Treatment-naïve patients with aRCC']","['axitinib (5 mg) orally twice daily or sunitinib', 'avelumab plus axitinib versus sunitinib', 'avelumab', 'avelumab plus axitinib']","['progression-free survival (PFS', 'PFS', 'OS and PFS in the overall population', 'PFS and overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",,0.268726,OS data were immature (PD-L1+ population: HR 0.828,"[{'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': ""Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, 450 Brookline Ave, Boston, MA 02215, USA;. Electronic address: toni_choueiri@dcfi.harvard.edu.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY 10065, USA.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Haanen', 'Affiliation': 'Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam, 1066 CX, The Netherlands.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Campbell', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA.'}, {'ForeName': 'Balaji', 'Initials': 'B', 'LastName': 'Venugopal', 'Affiliation': 'University of Glasgow, Beatson West of Scotland Cancer Centre, 1053, Great Western Rd, Glasgow, G12 0YN, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kollmannsberger', 'Affiliation': 'British Columbia Cancer Agency, Vancouver Centre, 600 West 10th Avenue, Vancouver, BC, V5Z 4E6, Canada.'}, {'ForeName': 'Gwenaelle', 'Initials': 'G', 'LastName': 'Gravis-Mescam', 'Affiliation': 'Institut Paoli-Calmettes, Department of Medical Oncology, Aix-Marseille Université, Inserm, CNRS, CRCM, Marseille, France.'}, {'ForeName': 'Motohide', 'Initials': 'M', 'LastName': 'Uemura', 'Affiliation': 'Osaka University Hospital, 2-15 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Jae Lyun', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Marc-Oliver', 'Initials': 'MO', 'LastName': 'Grimm', 'Affiliation': 'Jena University Hospital, Department of Urology, Am Klinikum 1, 07747 Jena, Germany.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Gurney', 'Affiliation': 'Macquarie University, F10A Building, 2 Technology Place, Suite 407, Level 4, Sydney, NSW, 2109, Australia.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Schmidinger', 'Affiliation': 'Medical University of Vienna; Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Waehringer Guertel 18-20, A-1090 Vienna, Austria.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Royal Marsden NHS Foundation Trust, Fulham Rd, London SW3 6JJ, UK.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Georgetown University Medical Center, 3800 Reservoir Rd NW, Washington, DC 20057, USA.'}, {'ForeName': 'Sumanta K', 'Initials': 'SK', 'LastName': 'Pal', 'Affiliation': 'City of Hope National Medical Center, 1500 E Duarte Rd, Duarte, CA 91010, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Pfizer, 300 Technology Square, Cambridge, MA 02138, USA.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Mariani', 'Affiliation': 'Pfizer Italia SRL, Via Anna Maria Mozzoni, 12, 20152 Milano, Italy.'}, {'ForeName': 'Sriram', 'Initials': 'S', 'LastName': 'Krishnaswami', 'Affiliation': 'Pfizer, 445 Eastern Point Rd, Groton, CT 06340, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Cislo', 'Affiliation': 'Pfizer, 235 E 42nd St, New York, NY 10017, USA.'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Chudnovsky', 'Affiliation': 'Pfizer, 300 Technology Square, Cambridge, MA 02138, USA.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Fowst', 'Affiliation': 'Pfizer Italia SRL, Via Anna Maria Mozzoni, 12, 20152 Milano, Italy.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'Pfizer, 445 Eastern Point Rd, Groton, CT 06340, USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'di Pietro', 'Affiliation': 'Pfizer Italia SRL, Via Anna Maria Mozzoni, 12, 20152 Milano, Lombardia, Italy.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Albiges', 'Affiliation': 'Institut Gustave Roussy, 114 rue Edouard Vaillant, Villejuif 94805, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.04.010']
5,32276071,Acute alcohol intoxication and expectations reshape the spatiotemporal functional architecture of executive control.,"While the deleterious effects of acute ethyl alcohol intoxication on executive control are well-established, the underlying spatiotemporal brain mechanisms remain largely unresolved. In addition, since the effects of alcohol are noticeable to participants, isolating the effects of the substance from those related to expectations represents a major challenge. We addressed these issues using a double-blind, randomized, parallel, placebo-controlled experimental design comparing the behavioral and electrical neuroimaging acute effects of 0.6 vs 0.02 ​g/kg alcohol intake recorded in 65 healthy adults during an inhibitory control Go/NoGo task. Topographic ERP analyses of covariance with self-reported dose expectations allowed to dissociate their neurophysiological effects from those of the substance. While alcohol intoxication increased response time variability and post-error slowing, bayesian analyses indicated that it did not modify commission error rates. Functionally, alcohol induced topographic ERP modulations over the periods of the stimulus-locked N2 and P3 components, arising from pre-supplementary motor and anterior cingulate areas. In contrast, alcohol decreased the strength of the response-locked anterior cingulate error-related component but not its topography. This pattern indicates that alcohol had a locally specific influence within the executive control network, but disrupted performance monitoring processes via global strength-based mechanisms. We further revealed that alcohol-related expectations induced temporally specific functional modulations of the early N2 stimulus-locked medio-lateral prefrontal activity, a processing phase preceding those influenced by the actual alcohol intake. Our collective findings thus not only reveal the mechanisms underlying alcohol-induced impairments in impulse control and error processing, but also dissociate substance- from expectations- related functional effects.",2020,"Functionally, alcohol induced topographic modulation over the periods of the stimulus-locked N2 and P3 event-related potential components, arising from pre- supplementary motor and anterior cingulate areas.",['65 healthy adults during an inhibitory control Go/NoGo task'],['placebo'],['strength of the response-locked anterior cingulate error'],"[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}]",65.0,0.0365488,"Functionally, alcohol induced topographic modulation over the periods of the stimulus-locked N2 and P3 event-related potential components, arising from pre- supplementary motor and anterior cingulate areas.","[{'ForeName': 'Farfalla', 'Initials': 'F', 'LastName': 'Ribordy Lambert', 'Affiliation': 'Neurology Unit, Medicine Section, Faculty of Science and Medicine, University of Fribourg, 1700, Fribourg, Switzerland.'}, {'ForeName': 'Corentin A', 'Initials': 'CA', 'LastName': 'Wicht', 'Affiliation': 'Neurology Unit, Medicine Section, Faculty of Science and Medicine, University of Fribourg, 1700, Fribourg, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mouthon', 'Affiliation': 'Neurology Unit, Medicine Section, Faculty of Science and Medicine, University of Fribourg, 1700, Fribourg, Switzerland.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Spierer', 'Affiliation': 'Neurology Unit, Medicine Section, Faculty of Science and Medicine, University of Fribourg, 1700, Fribourg, Switzerland. Electronic address: lucas.spierer@unifr.ch.'}]",NeuroImage,['10.1016/j.neuroimage.2020.116811']
6,32339664,"Effect of prefrontal tDCS on resting brain fMRI graph measures in Alcohol Use Disorders: A randomized, double-blind, sham-controlled study.","OBJECTIVES


Transcranial Direct Current Stimulation (tDCS) is a promising new adjuvant approach in the treatment of Alcohol Use Disorders (AUDs) that has the potential to ameliorate the aberrations secondary to chronic alcohol use. In this study, using a randomized, double-blind, sham-controlled, parallel-arm design, we examined the effects of prefrontal tDCS on resting-state functional magnetic resonance imaging (rsfMRI) and its correlates with impulsivity and time to first lapse in subjects with AUDs.
METHODS


Patients with AUD as per DSM-5 criteria were randomly allocated to receive a five-day course of either verum-tDCS (n = 12) or sham-tDCS (n = 12). Of them, 21 patients (verum/sham = 11/10) participated in both baseline and post-intervention 10-min rsfMRI sessions. Outside the scanner, subjects also performed the Stop-Signal Task at two time-points (baseline and post-intervention), which provided a measure of changes in impulsivity following tDCS. After completion of the post-intervention scan, all subjects were discharged and were followed-up for 90 days post-discharge or until lapse to first alcohol use.
RESULTS


Graph theoretical analysis of rsfMRI data revealed that verum-tDCS (but not sham) resulted in a significant increase in the global efficiency of brain networks with a concurrent significant reduction in global clustering; network-based statistical analysis identified a significant increase in the functional connectivity of a specific sub-network involving prefrontal regions. Furthermore, increased global efficiency of brain networks following verum tDCS predicted a significantly reduced likelihood of relapse. In addition, a reduction in the global clustering had a significant positive correlation with a reduction in the measure of impulsivity.
CONCLUSIONS


The present study adds further support to the increasing evidence base for the clinical utility of tDCS in AUDs. Importantly, we observed improvement in both whole-brain network efficiency as well as inter-regional connectivity within a specific local prefrontal sub-network that is relevant to the neurobiology of AUDs. Replication and extension of these promising leads from the present study can facilitate clinical translation of tDCS, given its advantages (i.e. safety, cost-effectiveness, administration ease with potential for remotely-supervised / home-based application) for treating patients with AUDs.",2020,"In addition, a reduction in the global clustering had a significant positive correlation with a reduction in the measure of impulsivity.
","['subjects with AUDs', 'Patients with AUD as per DSM-5 criteria', 'Alcohol Use Disorders', '21 patients (verum/sham\u202f=\u202f11/10) participated in both baseline and post-intervention 10-min rsfMRI sessions']","['prefrontal tDCS', 'Transcranial Direct Current Stimulation (tDCS', 'verum-tDCS (n\u202f=\u202f12) or sham-tDCS']","['resting brain fMRI graph measures', 'likelihood of relapse', 'global efficiency of brain networks', 'functional connectivity of a specific sub-network involving prefrontal regions']","[{'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]",,0.15234,"In addition, a reduction in the global clustering had a significant positive correlation with a reduction in the measure of impulsivity.
","[{'ForeName': 'Bharath', 'Initials': 'B', 'LastName': 'Holla', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Jitendriya', 'Initials': 'J', 'LastName': 'Biswal', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Vinutha', 'Initials': 'V', 'LastName': 'Ramesh', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Venkataram', 'Initials': 'V', 'LastName': 'Shivakumar', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Rose Dawn', 'Initials': 'RD', 'LastName': 'Bharath', 'Affiliation': 'Neuroimaging and Interventional Radiology, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Benegal', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Ganesan', 'Initials': 'G', 'LastName': 'Venkatasubramanian', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India. Electronic address: gvs@nimhans.ac.in.'}, {'ForeName': 'Prabhat Kumar', 'Initials': 'PK', 'LastName': 'Chand', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Pratima', 'Initials': 'P', 'LastName': 'Murthy', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.109950']
7,32339768,Risk reduction through family therapy (RRFT): Protocol of a randomized controlled efficacy trial of an integrative treatment for co-occurring substance use problems and posttraumatic stress disorder symptoms in adolescents who have experienced interpersonal violence and other traumatic events.,"Decades of research demonstrate that childhood exposure to traumatic events, particularly interpersonal violence experiences (IPV; sexual abuse, physical abuse, witnessing violence), increases risk for negative behavioral and emotional outcomes, including substance use problems (SUP) and posttraumatic stress disorder (PTSD). Despite this well-established link-including empirical support for shared etiological and functional connections between SUP and PTSD -the field has been void of a gold standard treatment for adolescent populations. To address this gap, our team recently completed a large randomized controlled trial to evaluate the efficacy of Risk Reduction through Family Therapy (RRFT), an integrative and exposure-based risk-reduction and treatment approach for adolescents who have experienced IPV and other traumatic events. The purpose of this paper is to provide a detailed description of the design and methods of this RCT designed to reduce SUP, PTSD symptoms, and related risk behaviors, with outcomes measured from pre-treatment through 18 months post-entry. Specifically, the recruitment and sampling procedures, assessment measures and methods, description of the intervention, and planned statistical approaches to evaluating the full range of outcomes are detailed. Clinical and research implications of this work are also discussed.",2020,"To address this gap, our team recently completed a large randomized controlled trial to evaluate the efficacy of Risk Reduction through Family Therapy (RRFT), an integrative and exposure-based risk-reduction and treatment approach for adolescents who have experienced IPV and other traumatic events.","['adolescents who have experienced IPV and other traumatic events', 'adolescents who have experienced interpersonal violence and other traumatic events']","['integrative treatment', 'Risk Reduction through Family Therapy (RRFT']","['SUP, PTSD symptoms, and related risk behaviors', 'negative behavioral and emotional outcomes, including substance use problems (SUP) and posttraumatic stress disorder (PTSD']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C4751223', 'cui_str': 'Traumatic event'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0015618', 'cui_str': 'Family therapy'}]","[{'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",,0.0401951,"To address this gap, our team recently completed a large randomized controlled trial to evaluate the efficacy of Risk Reduction through Family Therapy (RRFT), an integrative and exposure-based risk-reduction and treatment approach for adolescents who have experienced IPV and other traumatic events.","[{'ForeName': 'Austin M', 'Initials': 'AM', 'LastName': 'Hahn', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Zachary W', 'Initials': 'ZW', 'LastName': 'Adams', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Chapman', 'Affiliation': 'Oregon Social Learning Center, Eugene, Oregon, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'McCart', 'Affiliation': 'Oregon Social Learning Center, Eugene, Oregon, USA.'}, {'ForeName': 'Ashli J', 'Initials': 'AJ', 'LastName': 'Sheidow', 'Affiliation': 'Oregon Social Learning Center, Eugene, Oregon, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'de Arellano', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Carla Kmett', 'Initials': 'CK', 'LastName': 'Danielson', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA. Electronic address: danielso@musc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106012']
8,32278029,"Addition of Chinese herbal remedy, Tongguan Capsules, to the standard treatment in patients with myocardial infarction improve the ventricular reperfusion and remodeling: Proteomic analysis of possible signaling pathways.","ETHNOPHARMACOLOGICAL RELEVANCE


Tongguan Capsules (TGC), a patented Chinese herbal remedy containing Salvia miltiorrhiza, Astragalus membranaceus, Borneolum syntheticum and Grasshopper, has been previously tested in the experimental model of animal hearts subjected to ischemia/reperfusion injury and its cardioprotective effect has been described.
AIM OF THE STUDY


This clinical trial was aimed at investigation whether the administration of TGC to patients suffered myocardial infarction (MI), would diminish dilation of the left ventricular (LV) and reduce development of the adverse clinical consequences.
METHODS


Eligible patients were enrolled and randomized 1:1 to TGC (4.5 g/d for 6 months) superimposed on standard treatment for MI, or the control group receiving the standard protocol alone. The outcomes of this trial were valued after 6 months and reported as a mean change from the baseline in LV end-systolic volume index (LVESVI) and as a frequency of MI recurrence, target-vessel revascularization, severity of heart failure or significant arrhythmia that required the additional therapy within 6 months. In addition, arrays with a panel of specific antibodies were used to assess levels of major cytokines and other pathophysiologic markers, that prompted conclusions about the mechanisms of the ultimate clinical outcomes in both patient's subgroups.
RESULTS


Meaningfully, obtained results indicated that MI patients randomly assigned to the TGC treatment, demonstrated a significant reduction of LVESVI (-4.03 ± 0.73 vs. 1.59 ± 0.43 mL/m 2 , P < 0.001) and a lower incidence of the major adverse cardiovascular events (5.45% vs. 11.44%, P = 0.033). Meaningfully, those patients consistently demonstrated lower serum levels of major inflammatory cytokines, as well as reduced levels of markers of myocardial apoptosis and fibrosis.
CONCLUSION


Addition of TGC to the current conventional treatment of MI patients, significantly reduced their adverse LV remodeling and contributed to the more positive clinical outcome.
TRIAL REGISTRATION


ChiCTR-IPR-17011618.",2020,"Meaningfully, those patients consistently demonstrated lower serum levels of major inflammatory cytokines, as well as reduced levels of markers of myocardial apoptosis and fibrosis (adjusted ??","['Eligible patients', 'patients with myocardial infarction', 'patients suffered myocardial infarction (MI']","['TGC', 'Chinese herbal remedy, Tongguan Capsules', 'standard treatment for MI, or the control group receiving the standard protocol alone']","['levels of markers of myocardial apoptosis and fibrosis', 'LVESVI', 'major adverse cardiovascular events', 'LV end-systolic volume index (LVESVI) and as a frequency of MI recurrence, target-vessel revascularization, severity of heart failure or significant arrhythmia', 'adverse LV remodeling', 'serum levels of major inflammatory cytokines']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C2605709', 'cui_str': 'tongguan'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0920324', 'cui_str': 'Homeopathic medicine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0600520', 'cui_str': 'Left Ventricular Remodeling'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",,0.109447,"Meaningfully, those patients consistently demonstrated lower serum levels of major inflammatory cytokines, as well as reduced levels of markers of myocardial apoptosis and fibrosis (adjusted ??","[{'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Mao', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China; Translational Medicine, Hospital for Sick Children, Toronto, M5G 0A4, Canada.'}, {'ForeName': 'Wenwei', 'Initials': 'W', 'LastName': 'Ouyang', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.'}, {'ForeName': 'Yuanshen', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Ruixiang', 'Initials': 'R', 'LastName': 'Zeng', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Xujie', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Qubo', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Biological Resource Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Minzhou', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. Electronic address: minzhouzhang@aliyun.com.'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Hinek', 'Affiliation': 'Translational Medicine, Hospital for Sick Children, Toronto, M5G 0A4, Canada.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.112794']
9,32347804,Using the Preparation Phase of the Multiphase Optimization Strategy to Develop a Messaging Component for Weight Loss: Formative and Pilot Research.,"BACKGROUND


Mobile messaging is often used in behavioral weight loss interventions, yet little is known as to the extent to which they contribute to weight loss when part of a multicomponent treatment package. The multiphase optimization strategy (MOST) is a framework that researchers can use to systematically investigate interventions that achieve desirable outcomes given specified constraints.
OBJECTIVE


This study describes the use of MOST to develop a messaging intervention as a component to test as part of a weight loss treatment package in a subsequent optimization trial.
METHODS


On the basis of our conceptual model, a text message intervention was created to support self-regulation of weight-related behaviors. We tested the messages in the ENLIGHTEN feasibility pilot study. Adults with overweight and obesity were recruited to participate in an 8-week weight loss program. Participants received a commercially available self-monitoring smartphone app, coaching calls, and text messages. The number and frequency of text messages sent were determined by individual preferences, and weight was assessed at 8 weeks.
RESULTS


Participants (n=9) in the feasibility pilot study lost 3.2% of their initial body weight over the 8-week intervention and preferred to receive 1.8 texts per day for 4.3 days per week. Researcher burden in manually sending messages was high, and the cost of receiving text messages was a concern. Therefore, a fully automated push notification system was developed to facilitate sending tailored daily messages to participants to support weight loss.
CONCLUSIONS


Following the completion of specifying the conceptual model and the feasibility pilot study, the message intervention went through a final iteration. Theory and feasibility pilot study results during the preparation phase informed critical decisions about automation, frequency, triggers, and content before inclusion as a treatment component in a factorial optimization trial.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01814072; https://clinicaltrials.gov/ct2/show/NCT01814072.",2020,"The multiphase optimization strategy (MOST) is a framework that researchers can use to systematically investigate interventions that achieve desirable outcomes given specified constraints.
",['Adults with overweight and obesity were recruited to participate in an 8-week weight loss program'],"['commercially available self-monitoring smartphone app, coaching calls, and text messages']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}]","[{'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]",[],,0.0318916,"The multiphase optimization strategy (MOST) is a framework that researchers can use to systematically investigate interventions that achieve desirable outcomes given specified constraints.
","[{'ForeName': 'Angela Fidler', 'Initials': 'AF', 'LastName': 'Pfammatter', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Sara Hoffman', 'Initials': 'SH', 'LastName': 'Marchese', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Pellegrini', 'Affiliation': 'Department of Exercise Science, Arnold School of Public Health, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Elyse', 'Initials': 'E', 'LastName': 'Daly', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Spring', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}]",JMIR formative research,['10.2196/16297']
10,32343994,Effects of electronic cigarette on platelet and vascular function after four months of use.,"We examined the effects of electronic cigarette on platelet and vascular function after 4 months of use compared to tobacco smoking. Forty smokers without cardiovascular disease were randomized to smoke either conventional cigarettes or an electronic cigarette (nicotine concentration of 12 mg/ml). At baseline and after four months, we measured a) platelet function by Platelet Function Analyzer PFA-100 and Light Transmission Aggregometry, b) pulse wave velocity, c) plasma malondialdehyde levels as oxidative stress index and d) the exhaled CO level. After 4 months, continuation of conventional cigarette smoking further impaired platelet function compared to vaping as assessed by PFA (mean increase 27.1 vs 11.6 s, p for interaction = 0.048) and by LTA (decline 24.1 vs 9.4%, p for interaction = 0.045). Conversely, compared to smoking, vaping resulted in greater reduction of exhaled CO (6.9 ppm vs 2.6, p for interaction < 0.001), improvement of PWV (decrease of 0.8 m/s vs increase of 0.8 m/s, p for interaction = 0.020) and reduction of MDA (reduction 0.13 vs increase 0.19 nmol/L, p for interaction = 0.035). Switching to electronic cigarette for 4 months has a neutral effect on platelet function while it reduces arterial stiffness and oxidative stress compared to tobacco smoking.",2020,"After 4 months, continuation of conventional cigarette smoking further impaired platelet function compared to vaping as assessed by PFA (mean increase 27.1 vs 11.6 s, p for interaction = 0.048) and by LTA (decline 24.1 vs 9.4%, p for interaction = 0.045).",['Forty smokers without cardiovascular disease'],"['electronic cigarette', 'conventional cigarettes or an electronic cigarette (nicotine concentration of 12\u202fmg/ml']","['exhaled CO', 'platelet function', 'platelet and vascular function', 'improvement of PWV', 'arterial stiffness and oxidative stress', 'reduction of MDA', 'platelet function by Platelet Function Analyzer PFA-100 and Light Transmission Aggregometry, b) pulse wave velocity, c) plasma malondialdehyde levels as oxidative stress index and d) the exhaled CO level']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439294', 'cui_str': 'g/L'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0920267', 'cui_str': 'Platelet aggregation test'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",40.0,0.0199673,"After 4 months, continuation of conventional cigarette smoking further impaired platelet function compared to vaping as assessed by PFA (mean increase 27.1 vs 11.6 s, p for interaction = 0.048) and by LTA (decline 24.1 vs 9.4%, p for interaction = 0.045).","[{'ForeName': 'Ignatios', 'Initials': 'I', 'LastName': 'Ikonomidis', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece. Electronic address: ignoik@gmail.com.""}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Katogiannis', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Gavriella', 'Initials': 'G', 'LastName': 'Kostelli', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Kallirhoe', 'Initials': 'K', 'LastName': 'Kourea', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Kyriakou', 'Affiliation': 'Laboratory of Haematology & Blood Bank Unit, ""Attikon"" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Athina', 'Initials': 'A', 'LastName': 'Kypraiou', 'Affiliation': 'Laboratory of Haematology & Blood Bank Unit, ""Attikon"" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tsoumani', 'Affiliation': 'Department of Pharmaceutical Chemistry, National and Kapodistrian University of Athens, School of Pharmacy, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Andreadou', 'Affiliation': 'Department of Pharmaceutical Chemistry, National and Kapodistrian University of Athens, School of Pharmacy, Athens, Greece.'}, {'ForeName': 'Vaia', 'Initials': 'V', 'LastName': 'Lambadiari', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Plotas', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Thymis', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Argirios E', 'Initials': 'AE', 'LastName': 'Tsantes', 'Affiliation': 'Laboratory of Haematology & Blood Bank Unit, ""Attikon"" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}]",Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association,['10.1016/j.fct.2020.111389']
11,32344098,Increased serum brain-derived neurotrophic factor with high-intensity interval training in stroke patients: A randomized controlled trial.,"BACKGROUND


Physiological adaptations of stroke patients after high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) remain unclear.
OBJECTIVE


This study determined the HIIT and MICT effects on aerobic capacity, cerebral oxygenation, peak cardiac output (CO), and serum brain-derived neurotrophic factor (BDNF) in stroke patients.
METHODS


We included 23 stroke patients with age about 55 years and stroke duration>24 months; participants completed 36 sessions of exercise training for 30min; 13 were randomly assigned to perform MICT at 60% of peak oxygen consumption (VO 2peak ) and 10 to perform HIIT at alternating 80% (3min) and 40% (3min) VO 2peak . Before and after interventions, we evaluated VO 2peak , peak CO, arteriovenous oxygen difference (AV O 2diff ), bilateral frontal cortex oxygenation (relative changes of oxyhemoglobin Δ[O 2 Hb], deoxyhemoglobin Δ[HHb], and total hemoglobin Δ[THb] levels), serum brain-derived neurotrophic factor (BDNF) level, and fluorescent cell staining for neuron morphology and percentage of cell-bearing neurites (% neurites).
RESULTS


HIIT induced significant increases in VO 2peak  (P=0.008), CO (P=0.038), Δ[HHb] (P=0.046), Δ[THb] (P=0.046), and serum BDNF level (P=0.012). The improvement in VO 2peak  was significantly greater with HIIT than MICT (20.7% vs. 9.8%, P=0.031), as was AV O 2diff  (P=0.041), Δ[HHb] (P=0.027), and serum BDNF level (P<0.001). HIIT facilitated neuron dendritic protrusions (greater % neurites, P=0.012) with prominent redistribution of mitochondria.
CONCLUSION


As compared with MICT, HIIT-improved aerobic capacity by increasing systemic tissue O 2  extraction in stroke patients. Increased cerebral O 2  utilization in the involved hemisphere was also identified after HIIT. These physiological adaptations may be associated with increased serum BDNF level. In vitro dendritic growth in neurons treated with serum from HIIT participants may imply significant effects on neuron activities as compared with MICT. CLINICALTRIALS.
GOV IDENTIFIER


NCT04135391.",2020,"HIIT facilitated neuron dendritic protrusions (greater % neurites, p=0.012) with prominent redistribution of mitochondria.
","['stroke patients after high', 'stroke patients', '23 stroke patients with age about 55 years and stroke duration > 24 months; participants completed 36 sessions of']","['exercise training', 'MICT at 60% of peak oxygen consumption (VO 2peak ', 'intensity interval training (HIIT) and moderate-intensity continuous training (MICT']","['VO 2peak', 'neuron activities', 'serum BDNF level', 'HIIT and MICT effects on aerobic capacity, cerebral oxygenation, peak cardiac output (CO), and serum brain-derived neurotrophic factor (BDNF', 'Δ[HHb', 'neuron dendritic protrusions', 'aerobic capacity', 'Increased cerebral O 2  utilization', 'CO', 'Δ[THb', 'VO 2peak , peak CO, arteriovenous oxygen difference (AV O 2diff ), bilateral frontal cortex oxygenation (relative changes of oxyhemoglobin Δ[O 2 Hb], deoxyhemoglobin Δ[HHb], and total hemoglobin Δ[THb] levels), serum brain-derived neurotrophic factor (BDNF) level, and fluorescent cell staining for neuron morphology and percentage of cell-bearing neurites (% neurites']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0027882', 'cui_str': 'Neuron'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0011305', 'cui_str': 'Dendrite'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0450109', 'cui_str': 'Arteriovenous'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030069', 'cui_str': 'Oxyhemoglobin'}, {'cui': 'C0057437', 'cui_str': 'Deoxyhemoglobin'}, {'cui': 'C0475206', 'cui_str': '% total hemoglobin'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent stain'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0085103', 'cui_str': 'Neurites'}]",23.0,0.209013,"HIIT facilitated neuron dendritic protrusions (greater % neurites, p=0.012) with prominent redistribution of mitochondria.
","[{'ForeName': 'Chih-Chin', 'Initials': 'CC', 'LastName': 'Hsu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Keelung Chang Gung Memorial Hospital, 204 Keelung, Taiwan; School of Medicine, College of Medicine, Chang Gung University, 333 Taoyuan, Taiwan; Community Research Center, Keelung Chang Gung Memorial Hospital, 204 Keelung, Taiwan. Electronic address: steele0618@gmail.com.'}, {'ForeName': 'Tieh-Cheng', 'Initials': 'TC', 'LastName': 'Fu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Keelung Chang Gung Memorial Hospital, 204 Keelung, Taiwan; Heart Failure Research Center, Keelung Chang Gung Memorial Hospital, 204 Keelung, Taiwan. Electronic address: fic6481@gmail.com.'}, {'ForeName': 'Shu-Chun', 'Initials': 'SC', 'LastName': 'Huang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Linkou Chang Gung Memorial Hospital, 333 Taoyuan, Taiwan. Electronic address: h0711@ms13.hinet.net.'}, {'ForeName': 'Carl Pai-Chu', 'Initials': 'CP', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Linkou Chang Gung Memorial Hospital, 333 Taoyuan, Taiwan.'}, {'ForeName': 'Jong-Shyan', 'Initials': 'JS', 'LastName': 'Wang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Keelung Chang Gung Memorial Hospital, 204 Keelung, Taiwan; Department of Physical Therapy, College of Medicine, Graduate Institute of Rehabilitation Science, Chang Gung University, 333 Taoyuan, Taiwan; Research Center for Chinese Herbal Medicine, College of Human Ecology, Chang Gung University of Science and Technology, 333 Taoyuan, Taiwan. Electronic address: s120011676@gmail.com.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.03.010']
12,32344105,The after-effect of noisy galvanic vestibular stimulation on postural control in young people: A randomized controlled trial.,"Noisy galvanic vestibular stimulation (nGVS) enhances the vestibular system. The center of pressure (COP) sway has been shown to decrease during nGVS, but the after-effect of nGVS remains unclear. The aim of this study is to elucidate the after-effect of nGVS on COP sway. We randomly assigned 26 participants to either control (sham stimulation) or nGVS groups. All participants were measured for COP sway while standing with open eyes at baseline, during stimulation, and after stimulation. In the nGVS group, sway path length, mediolateral mean velocity, and anteroposterior mean velocity decreased both during stimulation and after stimulation compared with baseline. Conversely, no significant difference in COP sway was detected in the control group. There was a correlation between the stimulation effect and the after-effect in the nGVS group, indicating that nGVS is effective for people with high baseline COP sway.",2020,"In the nGVS group, sway path length, mediolateral mean velocity, and anteroposterior mean velocity decreased both during stimulation and after stimulation compared with baseline.",['young people'],"['noisy galvanic vestibular stimulation', 'nGVS', 'control (sham stimulation) or nGVS', 'Noisy galvanic vestibular stimulation (nGVS']","['sway path length, mediolateral mean velocity, and anteroposterior mean velocity', 'COP sway', 'postural control']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}]",26.0,0.0573894,"In the nGVS group, sway path length, mediolateral mean velocity, and anteroposterior mean velocity decreased both during stimulation and after stimulation compared with baseline.","[{'ForeName': 'Yasuto', 'Initials': 'Y', 'LastName': 'Inukai', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan; Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan. Electronic address: inukai@nuhw.ac.jp.'}, {'ForeName': 'Naofumi', 'Initials': 'N', 'LastName': 'Otsuru', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan; Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Saito', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan; Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Miyaguchi', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan; Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Kojima', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan; Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan.'}, {'ForeName': 'Hirotake', 'Initials': 'H', 'LastName': 'Yokota', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan; Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Nagasaka', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan; Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Onishi', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan; Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan.'}]",Neuroscience letters,['10.1016/j.neulet.2020.135009']
13,32341044,(Cost-)effectiveness of lower extremity nerve decompression surgery in subjects with diabetes: the DeCompression (DECO) trial-study protocol for a randomised controlled trial.,"INTRODUCTION


The peripheral nerves of patients with diabetes are often pathologically swollen, which results in entrapment at places of anatomical narrowing. This results in nerve dysfunction. Surgical treatment of compression neuropathies in the lower extremities (lower extremity nerve decompression (LEND)) results in relief of symptoms and gain in peripheral nerve function, which may lead to less sensory loss (short term) and less associated detrimental effects including foot ulceration and amputations, and lower costs (long term). The aim of the DeCompression trial is to evaluate the effectiveness and (cost-)effectiveness of surgical decompression of compressed lower extremity nerves (LEND surgery) compared with patients treated with conventional (non-surgical) care.
METHODS AND ANALYSIS


A stratified randomised (1 to 1) controlled trial comparing LEND surgery (intervention) with conventional non-surgical care (control strategy) in subjects with diabetes with problems of neuropathy due to compression neuropathies in the lower extremity. Randomisation is stratified for participating hospital (n=11) and gender. Patients and controls have the same follow-up at 1.5, 3, 6, 9, 12, 18, 24 and 48 months. Participants (n=344) will be recruited in 12 months and enrolled in all affiliated hospitals in which they receive both the intervention or conventional non-surgical care and follow-up. Outcome assessors are blinded to group assignment.
PRIMARY OUTCOME


disease-specific quality of life (Norfolk Quality of Life Questionnaire-Diabetic Neuropathy).
SECONDARY OUTCOMES


health-related quality of life (EuroQoL 5-dimension 5-level (EQ-5D5L), 36-item Short Form (SF-36)), plantar sensation (Rotterdam Diabetic Foot Test Battery), incidence of ulcerations/amputations, resource use and productivity loss (Medical Cost Questionnaire, Productivity Cost Questionnaire) during follow-up. The incremental cost-effectiveness ratio will be estimated on the basis of the collected empirical data and a cost-utility model.
ETHICS AND DISSEMINATION


Ethics approval has been granted by the Medical Research Ethics Committee of Utrecht University Medical Center (reference: NL68312.041.19v5, protocol number: 19-335/M). Dissemination of results will be via journal articles and presentations at national and international conferences.
TRIAL REGISTRATION NUMBER


NetherlandsTrial Registry NL7664.",2020,"Surgical treatment of compression neuropathies in the lower extremities (lower extremity nerve decompression (LEND)) results in relief of symptoms and gain in peripheral nerve function, which may lead to less sensory loss (short term) and less associated detrimental effects including foot ulceration and amputations, and lower costs (long term).","['participating hospital (n=11) and gender', 'Utrecht University Medical Center (reference', 'patients treated with conventional (non-surgical) care', 'subjects with diabetes with problems of neuropathy due to compression neuropathies in the lower extremity', 'subjects with diabetes', 'Participants (n=344) will be recruited in 12 months and enrolled in all affiliated hospitals in which they receive both the intervention or conventional non-surgical care and follow-up']","['surgical decompression of compressed lower extremity nerves (LEND surgery', 'extremity nerve decompression surgery', 'LEND surgery (intervention) with conventional non-surgical care (control strategy']","['incremental cost-effectiveness ratio', 'disease-specific quality of life (Norfolk Quality of Life Questionnaire-Diabetic Neuropathy', 'health-related quality of life (EuroQoL 5-dimension 5-level (EQ-5D5L), 36-item Short Form (SF-36)), plantar sensation (Rotterdam Diabetic Foot Test Battery), incidence of ulcerations/amputations, resource use and productivity loss (Medical Cost Questionnaire, Productivity Cost Questionnaire']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0393814', 'cui_str': 'Hereditary liability to pressure palsies'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0376530', 'cui_str': 'Surgical decompression - action'}, {'cui': 'C0446822', 'cui_str': 'Peripheral nerve of lower limb'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0196571', 'cui_str': 'Decompression of nerve'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0454866', 'cui_str': 'Norfolk'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0206172', 'cui_str': 'Diabetic foot'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",344.0,0.135549,"Surgical treatment of compression neuropathies in the lower extremities (lower extremity nerve decompression (LEND)) results in relief of symptoms and gain in peripheral nerve function, which may lead to less sensory loss (short term) and less associated detrimental effects including foot ulceration and amputations, and lower costs (long term).","[{'ForeName': 'Willem D', 'Initials': 'WD', 'LastName': 'Rinkel', 'Affiliation': 'Department of Plastic-, Reconstructive- and Hand Surgery, Utrecht University Medical Center, Utrecht, The Netherlands w.d.rinkel@umcutrecht.nl.'}, {'ForeName': 'Tirzah M', 'Initials': 'TM', 'LastName': 'Fakkel', 'Affiliation': 'Department of Plastic-, Reconstructive- and Hand Surgery, Utrecht University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Castro Cabezas', 'Affiliation': 'Department of Internal Medicine, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'Erwin', 'Initials': 'E', 'LastName': 'Birnie', 'Affiliation': 'Department of Plastic-, Reconstructive- and Hand Surgery, Utrecht University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'J Henk', 'Initials': 'JH', 'LastName': 'Coert', 'Affiliation': 'Department of Plastic-, Reconstructive- and Hand Surgery, Utrecht University Medical Center, Utrecht, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-035644']
14,32341047,Text messages for primary prevention of cardiovascular disease: the TextMe2 randomised controlled trial protocol.,"INTRODUCTION


Mobile health may be an effective means of delivering customised individually directed health promotion interventions for cardiovascular disease (CVD) primary prevention. The aim of this study is to evaluate the effectiveness of a lifestyle-focused text messaging programme for primary CVD prevention.
METHODS AND ANALYSIS


Single-blind randomised controlled trial with 6 months' follow-up in 246 patients with moderate-high absolute cardiovascular risk and without coronary heart disease recruited from a rapid access cardiology clinic. Participants will be randomised to receive either usual care or TextMe2 (text message-based prevention programme). The TextMe2 programme provides support, motivation and education on five topics: diet, physical activity, smoking, general cardiovascular health and medication adherence, and is delivered in four text messages per week over 6 months. The primary outcome is change in the proportion of patients who have three or more of five key modifiable risk factors that are uncontrolled (low-density lipoprotein >2.0 mmol/L, systolic blood pressure >140 mm Hg, body mass index >24.9 kg/m 2 , physical activity (less than the equivalent of 150 min of moderate intensity each week), current smoker). Secondary outcomes are changes in single biomedical risk factors, behavioural risk factors, quality of life, depression/anxiety scores, medication adherence, cardiovascular health literacy and hospital readmissions/representations. Analysis will be according to the intention-to-treat principle and full statistical analysis plan developed prior to data lock.
ETHICS AND DISSEMINATION


This study has been approved by the Western Sydney Local Health District Human Research Ethics Committee at Westmead (AU/RED/HREC/17/WMEAD/186). Results will be presented at scientific meetings and published in peer-reviewed publications.
TRIAL REGISTRATION NUMBER


ACTRN12618001153202.",2020,"INTRODUCTION


Mobile health may be an effective means of delivering customised individually directed health promotion interventions for cardiovascular disease (CVD) primary prevention.",['246 patients with moderate-high absolute cardiovascular risk and without coronary heart disease recruited from a rapid access cardiology clinic'],"['lifestyle-focused text messaging programme', 'usual care or TextMe2 (text message-based prevention programme']","['systolic blood pressure ', 'physical activity', 'cardiovascular disease', 'changes in single biomedical risk factors, behavioural risk factors, quality of life, depression/anxiety scores, medication adherence, cardiovascular health literacy and hospital readmissions/representations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3810847', 'cui_str': 'Cardiology clinic'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}]",246.0,0.211198,"INTRODUCTION


Mobile health may be an effective means of delivering customised individually directed health promotion interventions for cardiovascular disease (CVD) primary prevention.","[{'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Klimis', 'Affiliation': 'Westmead Applied Research Centre, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia harry.klimis@sydney.edu.au.'}, {'ForeName': 'Aravinda', 'Initials': 'A', 'LastName': 'Thiagalingam', 'Affiliation': 'Westmead Applied Research Centre, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Clara K', 'Initials': 'CK', 'LastName': 'Chow', 'Affiliation': 'Westmead Applied Research Centre, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-036767']
15,32345699,"Study protocol for optimising glycaemic control in type 1 diabetes treated with multiple daily insulin injections: intermittently scanned continuous glucose monitoring, carbohydrate counting with automated bolus calculation, or both? A randomised controlled trial.","INTRODUCTION


There are beneficial effects of advanced carbohydrate counting with an automatic bolus calculator (ABC) and intermittently scanned continuous glucose monitoring (isCGM) in persons with type 1 diabetes. We aim to compare the effects of isCGM, training in carbohydrate counting with ABC and the combination of the two concepts with standard care.
METHODS AND ANALYSIS


A multi-centre randomised controlled trial with inclusion criteria: ≥18 years, type 1 diabetes ≥1 year, injection therapy, HbA1c >53 mmol/mol, whereas daily use of carbohydrate counting and/or CGM/isCGM wear are exclusion criteria. Inclusion was initiated in October 2018 and is ongoing. Eligible persons are randomised into four groups: standard care, ABC, isCGM or ABC+isCGM. Devices used are FreeStyle Libre Flash and smart phone diabetes application mySugr. Participants attend group courses according to treatment allocation with different educational contents. Participants are followed for 26 weeks with clinical visits and telephone consultations. At baseline and at study end, participants wear blinded CGM, have blood samples performed and fill in questionnaires on person-related outcomes, and at baseline also on personality traits and hypoglycaemia awareness. The primary outcome is the difference in time spent in normoglycaemia (4-10 mmol/L) at study end versus baseline between the isCGM group and the standard care group. Secondary outcomes will also be analysed. Results are expected in 2020.
ETHICS AND DISSEMINATION


Regional Scientific Ethics Committee approval (H-17040573). Results will be sought disseminated at conferences and in high impact journals.Trial registration numberClinicalTrial.gov registry (NCT03682237).",2020,There are beneficial effects of advanced carbohydrate counting with an automatic bolus calculator (ABC) and intermittently scanned continuous glucose monitoring (isCGM) in persons with type 1 diabetes.,"['Eligible persons', 'inclusion criteria: ≥18 years, type 1 diabetes ≥1 year, injection therapy, HbA1c >53 mmol/mol, whereas daily use of carbohydrate counting and/or CGM/isCGM wear are exclusion criteria', 'type 1 diabetes treated with multiple daily insulin injections', 'persons with type 1 diabetes']","['advanced carbohydrate counting with an automatic bolus calculator (ABC) and intermittently scanned continuous glucose monitoring (isCGM', 'standard care, ABC, isCGM or ABC+isCGM']","['personality traits and hypoglycaemia awareness', 'time spent in normoglycaemia']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C1562940', 'cui_str': 'Carbohydrate counting'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0870240', 'cui_str': 'Calculator'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0233849', 'cui_str': 'Character trait finding'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.208788,There are beneficial effects of advanced carbohydrate counting with an automatic bolus calculator (ABC) and intermittently scanned continuous glucose monitoring (isCGM) in persons with type 1 diabetes.,"[{'ForeName': 'Anna Lilja', 'Initials': 'AL', 'LastName': 'Secher', 'Affiliation': 'Clinical Research, Steno Diabetes Center Copenhagen, Gentofte, Denmark anna.elisabet.lilja.secher@regionh.dk.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Pedersen-Bjergaard', 'Affiliation': 'Endocrine Section, Department of Endocrinology and Nephrology, Nordsjællands Hospital, Hillerod, Denmark.'}, {'ForeName': 'Ole Lander', 'Initials': 'OL', 'LastName': 'Svendsen', 'Affiliation': 'Department of Endocrinology I, Bispebjerg Hospital, Kobenhavn, Denmark.'}, {'ForeName': 'Birthe', 'Initials': 'B', 'LastName': 'Gade-Rasmussen', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Almdal', 'Affiliation': 'Department of Endocrinology, Rigshospitalet, Kobenhavn, Denmark.'}, {'ForeName': 'Liv', 'Initials': 'L', 'LastName': 'Dørflinger', 'Affiliation': 'Administration, Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Dorte', 'Initials': 'D', 'LastName': 'Vistisen', 'Affiliation': 'Clinical Research, Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Nørgaard', 'Affiliation': 'Clinical Research, Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-036474']
16,32345700,Investigating the effect of clinical pharmacist intervention in transitions of care on drug-related hospital readmissions among the elderly: study protocol for a randomised controlled trial.,"INTRODUCTION


Drug-related problems (DRPs) are a major cause of unplanned hospital admissions among elderly people, and transitions of care have been emphasised as a key area for improving patient safety. We have designed a complex clinical pharmacist intervention that targets people ≥75 years of age undergoing transitions of care from hospital to home and primary care. The main objective is to investigate if the intervention can reduce the risk of unplanned drug-related readmission within the first 180 days after the person is discharged from hospital.
METHODS AND ANALYSIS


This is a randomised, controlled, superiority trial with two parallel arms. A total of 700 people ≥75 years will be assigned to either intervention or routine care (control). The intervention, which aims to find and manage DRPs, is initiated within a week of the person being discharged from hospital and combines repeated medical chart reviews, phone interviews and in some cases medication reviews. People in both study arms may have been the subject of a medication review during their ward stay. As the primary outcome, we will measure time until unplanned drug-related readmission within 180 days of leaving hospital and use log rank tests and Cox proportional hazard models to analyse differences between the groups. Further investigations of subgroup effects and adjustments of the regression models will be based on heart failure and cognitive impairment as prognostic factors.
ETHICS AND DISSEMINATION


The study has been approved by the Regional Ethical Review Board in Umeå (registration numbers 2017-69-31M, 2018-83-32M and 2018-254-32M). We intend to publish the results with open access in international peer-reviewed journals and present our findings at international conferences. The trial is expected to result in more than one published article and form part of two PhD theses.
TRIAL REGISTRATION NUMBER


NCT03671629.",2020,"The intervention, which aims to find and manage DRPs, is initiated within a week of the person being discharged from hospital and combines repeated medical chart reviews, phone interviews and in some cases medication reviews.","['Umeå (registration numbers 2017-69-31M, 2018-83-32M and 2018-254-32M', '700 people ≥75 years', 'transitions of care on drug-related hospital readmissions among the elderly', 'people ≥75 years of age undergoing transitions of care from hospital to home and primary care']","['clinical pharmacist intervention', 'intervention or routine care (control']",['measure time until unplanned drug-related readmission within 180 days of leaving hospital and use log rank tests and Cox proportional hazard models'],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3266241', 'cui_str': 'Transition of care'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C1449564', 'cui_str': 'Clinical pharmacist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0010235', 'cui_str': 'Cox Proportional Hazards Models'}]",,0.128434,"The intervention, which aims to find and manage DRPs, is initiated within a week of the person being discharged from hospital and combines repeated medical chart reviews, phone interviews and in some cases medication reviews.","[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Kindstedt', 'Affiliation': 'Department of Integrative Medical Biology, Umeå University, Umeå, Sweden jonas.kindstedt@umu.se.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Svahn', 'Affiliation': 'Department of Integrative Medical Biology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sjölander', 'Affiliation': 'Department of Integrative Medical Biology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Eva-Lotta', 'Initials': 'EL', 'LastName': 'Glader', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Lövheim', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Integrative Medical Biology, Umeå University, Umeå, Sweden.'}]",BMJ open,['10.1136/bmjopen-2019-036650']
17,32352662,[Comparison of efficiency and safety of laparoscopic manual esophagoenterostomy and esophagoenterostomy with mechanical anastomotic devices after laparoscopic gastrectomy for stomach cancer].,"OBJECTIVE


To compare laparoscopic manual esophagoenterostomy and esophagoenterostomy with mechanical stapling anastomotic devices after laparoscopic gastrectomy for stomach cancer.
MATERIAL AND METHODS


There were 34 patients who underwent laparoscopic gastrectomy for stomach in 2015-2018. Roux-en-Y esophagoenterostomy was used to reconstruct the gastrointestinal tract. Manual anastomoses were performed in 18 patients (group 1), stapled anastomoses (endogia 45 mm, covidien, mansfield, ma, usa) - in 16 patients (group 2). There was no randomization. Surgery duration, length of icu-stay, terms of enteral nutrition initiation, postoperative complications, hospital-stay were analyzed.
RESULTS


Mean duration of surgery in the first group was 217 (184-302) min, in the second group - 201 (162-311) min. Duration of surgery in the first group was 1.08-fold higher than in the second group (95% CI 1.03-1.13,  p =0.05). Mean blood loss was 145 ml in both groups. Mean icu-stay was 20.2 (17-42) hours in the first group and 21.1 (16.2-46) hours in the second group (ratio 0.96, 95% CI 0.92-1.01,  p =0.06). Total enteral feeding (sipping) was initiated on the third day in both groups. Mean postoperative hospital-stay was 9.21 (6-13) days in the first group and 9.23 (6-12 days) days in the second group (ratio 0.99, 95% CI 0,95-1.02,  p =0.06). Postoperative morbidity was 5.5% in the first group and 6.25% in the second group.
CONCLUSION


Laparoscopic manual esophagoenterostomy proposed by our surgical team does not have disadvantages in comparison with stapling anastomotic devices and these methods may be alternative to each other.",2020,"9.23 (6-12 days) days in the second group (ratio 0.99, 95% CI 0,95-1.02,  p =0.06).","['There were 34 patients who underwent', 'for stomach in 2015-2018', 'stomach cancer']","['laparoscopic manual esophagoenterostomy and esophagoenterostomy with mechanical anastomotic devices', 'stapled anastomoses', 'laparoscopic gastrectomy', 'Roux-en-Y esophagoenterostomy', 'laparoscopic manual esophagoenterostomy and esophagoenterostomy with mechanical stapling anastomotic devices']","['Mean duration of surgery', 'Duration of surgery', 'Surgery duration, length of icu-stay, terms of enteral nutrition initiation, postoperative complications, hospital-stay', 'Total enteral feeding (sipping', 'Mean icu-stay', 'Postoperative morbidity', 'Mean blood loss', 'Mean postoperative hospital-stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0192357', 'cui_str': 'Anastomosis of esophagus to small bowel'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0677554', 'cui_str': 'Anastomosis - action'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0002804', 'cui_str': 'Roux-en-Y - action'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",18.0,0.032435,"9.23 (6-12 days) days in the second group (ratio 0.99, 95% CI 0,95-1.02,  p =0.06).","[{'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Gallyamov', 'Affiliation': 'Sechenov First Moscow State Medical University of the Ministry of Health of Russia (Sechenov University), Moscow, Russia.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Agapov', 'Affiliation': 'Lomonosov Moscow State University, Faculty of Fundamental Medicine, Moscow, Russia.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Donchenko', 'Affiliation': 'Lomonosov Moscow State University, Faculty of Fundamental Medicine, Moscow, Russia.'}, {'ForeName': 'E E', 'Initials': 'EE', 'LastName': 'Gallyamov', 'Affiliation': 'Federal Medical and Biological Agency of Russia, Moscow, Russia.'}, {'ForeName': 'V V', 'Initials': 'VV', 'LastName': 'Kakotkin', 'Affiliation': 'Lomonosov Moscow State University, Faculty of Fundamental Medicine, Moscow, Russia.'}]",Khirurgiia,['10.17116/hirurgia202004111']
18,32342642,Resting metabolic rate and skeletal muscle SERCA and Na +  /K +  ATPase activities are not affected by fish oil supplementation in healthy older adults.,"Omega-3 polyunsaturated fatty acids (PUFAs) have unique properties purported to influence several aspects of metabolism, including energy expenditure and protein function. Supplementing with n-3 PUFAs may increase whole-body resting metabolic rate (RMR), by enhancing Na +  /K +  ATPase (NKA) activity and reducing the efficiency of sarcoplasmic reticulum (SR) Ca 2+  ATPase (SERCA) activity by inducing a Ca 2+  leak-pump cycle. The purpose of this study was to examine the effects of fish oil (FO) on RMR, substrate oxidation, and skeletal muscle SERCA and NKA pump function in healthy older individuals. Subjects (n = 16 females; n = 8 males; 65 ± 1 years) were randomly assigned into groups supplemented with either olive oil (OO) (5 g/day) or FO (5 g/day) containing 2 g/day eicosapentaenoic acid and 1 g/day docosahexaenoic acid for 12 weeks. Participants visited the laboratory for RMR and substrate oxidation measurements after an overnight fast at weeks 0 and 12. Skeletal muscle biopsies were taken during weeks 0 and 12 for analysis of NKA and SERCA function and protein content. There was a main effect of time with decrease in RMR (5%) and fat oxidation (18%) in both the supplementation groups. The kinetic parameters of SERCA and NKA maximal activity, as well as the expression of SR and NKA proteins, were not affected after OO and FO supplementation. In conclusion, these results suggest that FO supplementation is not effective in altering RMR, substrate oxidation, and skeletal muscle SERCA and NKA protein levels and activities, in healthy older men and women.",2020,There was a main effect of time with decrease in RMR (5%) and fat oxidation (18%) in both the supplementation groups.,"['healthy older men and women', 'healthy older individuals', 'healthy older adults', 'Subjects (n\xa0=\xa016 females; n\xa0=\xa08 males; 65\xa0±\xa01\xa0years']","['Omega-3 polyunsaturated fatty acids (PUFAs', 'olive oil (OO', 'n-3 PUFAs', 'fish oil (FO', 'FO (5\xa0g/day) containing 2\xa0g/day eicosapentaenoic acid and 1\xa0g/day docosahexaenoic acid', 'FO supplementation']","['RMR', 'RMR, substrate oxidation, and skeletal muscle SERCA and NKA protein levels and activities', 'body resting metabolic rate (RMR), by enhancing Na +  /K +  ATPase (NKA) activity', 'RMR and substrate oxidation measurements', 'fat oxidation', 'RMR, substrate oxidation, and skeletal muscle SERCA and NKA pump function', 'efficiency of sarcoplasmic reticulum (SR) Ca 2+  ATPase (SERCA) activity']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0001473', 'cui_str': 'Adenosinetriphosphatase'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036226', 'cui_str': 'Sarcoplasmic reticulum'}, {'cui': 'C0596235', 'cui_str': 'Calcium ion'}]",,0.0348786,There was a main effect of time with decrease in RMR (5%) and fat oxidation (18%) in both the supplementation groups.,"[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Jannas-Vela', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ON, Canada.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Klingel', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ON, Canada.'}, {'ForeName': 'Daniel T', 'Initials': 'DT', 'LastName': 'Cervone', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ON, Canada.'}, {'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Wickham', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ON, Canada.'}, {'ForeName': 'George J F', 'Initials': 'GJF', 'LastName': 'Heigenhauser', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Mutch', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ON, Canada.'}, {'ForeName': 'Graham P', 'Initials': 'GP', 'LastName': 'Holloway', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ON, Canada.'}, {'ForeName': 'Lawrence L', 'Initials': 'LL', 'LastName': 'Spriet', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ON, Canada.'}]",Physiological reports,['10.14814/phy2.14408']
19,32343642,"Irinotecan, Temozolomide, and Dinutuximab With GM-CSF in Children With Refractory or Relapsed Neuroblastoma: A Report From the Children's Oncology Group.","PURPOSE


The combination of irinotecan, temozolomide, dintuximab, and granulocyte-macrophage colony-stimulating factor (I/T/DIN/GM-CSF) demonstrated activity in patients with relapsed/refractory neuroblastoma in the randomized Children's Oncology Group ANBL1221 trial. To more accurately assess response rate and toxicity, an expanded cohort was nonrandomly assigned to I/T/DIN/GM-CSF.
PATIENTS AND METHODS


Patients were eligible at first relapse or first designation of refractory disease. Oral T and intravenous (IV) irinotecan were administered on days 1 to 5 of 21-day cycles. DIN was administered IV (days 2-5), and GM-CSF was administered subcutaneously (days 6-12). The primary end point was objective response, analyzed on an intent-to-treat basis per the International Neuroblastoma Response Criteria.
RESULTS


Seventeen eligible patients were randomly assigned to I/T/DIN/GM-CSF (February 2013 to March 2015); 36 additional patients were nonrandomly assigned to I/T/DIN/GM-CSF (August 2016 to May 2017). Objective (complete or partial) responses were observed in nine (52.9%) of 17 randomly assigned patients (95% CI, 29.2% to 76.7%) and 13 (36.1%) of 36 expansion patients (95% CI, 20.4% to 51.8%). Objective responses were seen in 22 (41.5%) of 53 patients overall (95% CI, 28.2% to 54.8%); stable disease was also observed in 22 of 53. One-year progression-free and overall survival for all patients receiving I/T/DIN/GM-CSF were 67.9% ± 6.4% (95% CI, 55.4% to 80.5%) and 84.9% ± 4.9% (95% CI, 75.3% to 94.6%), respectively. Two patients did not receive protocol therapy and were evaluable for response but not toxicity. Common grade ≥ 3 toxicities were fever/infection (18 [35.3%] of 51), neutropenia (17 [33.3%] of 51), pain (15 [29.4%] of 51), and diarrhea (10 [19.6%] of 51). One patient met protocol-defined criteria for unacceptable toxicity (grade 4 hypoxia). Higher DIN trough levels were associated with response.
CONCLUSION


I/T/DIN/GM-CSF has significant antitumor activity in patients with relapsed/refractory neuroblastoma. Study of chemoimmunotherapy in the frontline setting is indicated, as is further evaluation of predictive biomarkers.",2020,"Objective responses were seen in 22 (41.5%) of 53 patients overall (95% CI, 28.2% to 54.8%); stable disease was also observed in 22 of 53.","['Seventeen eligible patients', ""patients with relapsed/refractory neuroblastoma in the randomized Children's Oncology Group"", 'Patients were eligible at first relapse or first designation of refractory disease', 'Children With Refractory or Relapsed Neuroblastoma', 'patients with relapsed/refractory neuroblastoma']","['Irinotecan, Temozolomide, and Dinutuximab With GM-CSF', 'chemoimmunotherapy', 'irinotecan, temozolomide, dintuximab, and granulocyte-macrophage colony-stimulating factor (I/T/DIN/GM-CSF', 'Oral T and intravenous (IV) irinotecan']","['Higher DIN trough levels', 'diarrhea', 'objective response, analyzed on an intent-to-treat basis per the International Neuroblastoma Response Criteria', 'neutropenia', 'response rate and toxicity', 'Objective (complete or partial) responses', 'overall survival', 'toxicity', 'fever/infection', 'stable disease', 'pain', 'antitumor activity', 'Objective responses']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0278695', 'cui_str': 'Neuroblastoma recurrent'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0281581', 'cui_str': 'dinutuximab'}, {'cui': 'C0079460', 'cui_str': 'Colony-stimulating factor, granulocyte-macrophage'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0574277', 'cui_str': 'Dinka language'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0574277', 'cui_str': 'Dinka language'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",17.0,0.0930635,"Objective responses were seen in 22 (41.5%) of 53 patients overall (95% CI, 28.2% to 54.8%); stable disease was also observed in 22 of 53.","[{'ForeName': 'Rajen', 'Initials': 'R', 'LastName': 'Mody', 'Affiliation': ""C.S. Mott Children's Hospital, University of Michigan, Ann Arbor, MI.""}, {'ForeName': 'Alice L', 'Initials': 'AL', 'LastName': 'Yu', 'Affiliation': 'University of California San Diego, San Diego, CA.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Naranjo', 'Affiliation': ""Children's Oncology Group Statistics and Data Center, University of Florida, Gainesville, FL.""}, {'ForeName': 'Fan F', 'Initials': 'FF', 'LastName': 'Zhang', 'Affiliation': ""Children's Oncology Group Statistics and Data Center, Monrovia, CA.""}, {'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'London', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Barry L', 'Initials': 'BL', 'LastName': 'Shulkin', 'Affiliation': ""St Jude Children's Research Hospital and University of Tennessee Health Science Center, Memphis, TN.""}, {'ForeName': 'Marguerite T', 'Initials': 'MT', 'LastName': 'Parisi', 'Affiliation': ""Seattle Children's Hospital and University of Washington, Seattle, WA.""}, {'ForeName': 'Sabah-E-Noor', 'Initials': 'SE', 'LastName': 'Servaes', 'Affiliation': ""Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Mitchell B', 'Initials': 'MB', 'LastName': 'Diccianni', 'Affiliation': 'University of California San Diego, San Diego, CA.'}, {'ForeName': 'Jacquelyn A', 'Initials': 'JA', 'LastName': 'Hank', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Mildred', 'Initials': 'M', 'LastName': 'Felder', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Birstler', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Sondel', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Shahab', 'Initials': 'S', 'LastName': 'Asgharzadeh', 'Affiliation': ""Children's Hospital of Los Angeles and University of Southern California, Los Angeles, CA.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Glade-Bender', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Katzenstein', 'Affiliation': ""Nemour's Children's Clinic, Jacksonville, FL.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Maris', 'Affiliation': ""Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Park', 'Affiliation': ""Seattle Children's Hospital and University of Washington, Seattle, WA.""}, {'ForeName': 'Rochelle', 'Initials': 'R', 'LastName': 'Bagatell', 'Affiliation': ""Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, PA.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00203']
20,32346371,Corrigendum: A Multicenter Phase II RCT to Compare the Effectiveness of EMDR Versus TAU in Patients With a First-Episode Psychosis and Psychological Trauma: A Protocol Design.,[This corrects the article DOI: 10.3389/fpsyt.2019.01023.].,2020,[This corrects the article DOI: 10.3389/fpsyt.2019.01023.].,['Patients With a First-Episode Psychosis and Psychological Trauma'],['EMDR Versus TAU'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C3203533', 'cui_str': 'Psychological trauma'}]","[{'cui': 'C0870535', 'cui_str': 'EMDR'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]",[],,0.0169125,[This corrects the article DOI: 10.3389/fpsyt.2019.01023.].,"[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Valiente-Gómez', 'Affiliation': 'Centre Forum Research Unit, Institut de Neuropsiquiatria i Addiccions (INAD), Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Pujol', 'Affiliation': 'IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Moreno-Alcázar', 'Affiliation': 'Centre Forum Research Unit, Institut de Neuropsiquiatria i Addiccions (INAD), Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Radua', 'Affiliation': ""Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Eila', 'Initials': 'E', 'LastName': 'Monteagudo-Gimeno', 'Affiliation': 'Department of Psychiatry and Forensic Medicine, School of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Itxaso', 'Initials': 'I', 'LastName': 'Gardoki-Souto', 'Affiliation': 'Centre Forum Research Unit, Institut de Neuropsiquiatria i Addiccions (INAD), Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Hogg', 'Affiliation': 'Centre Forum Research Unit, Institut de Neuropsiquiatria i Addiccions (INAD), Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'Maria José', 'Initials': 'MJ', 'LastName': 'Álvarez', 'Affiliation': 'Mental Health Department, Vic Hospital Consortium, Barcelona, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Safont', 'Affiliation': 'CIBERSAM, Madrid, Spain.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Lupo', 'Affiliation': 'Centre Forum Research Unit, Institut de Neuropsiquiatria i Addiccions (INAD), Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Pérez', 'Affiliation': 'IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.'}, {'ForeName': 'Benedikt L', 'Initials': 'BL', 'LastName': 'Amann', 'Affiliation': 'Centre Forum Research Unit, Institut de Neuropsiquiatria i Addiccions (INAD), Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00283']
21,32342648,Do the anatomical and physiological properties of a muscle determine its adaptive response to different loading protocols?,"It has been proposed that superior muscle hypertrophy may be obtained by training muscles predominant in type I fibers with lighter loads and those predominant in type II fibers with heavier loads.
PURPOSE


To evaluate longitudinal changes in muscle strength and hypertrophy of the soleus (a predominantly slow-twitch muscle) and gastrocnemius (muscle with a similar composition of slow and fast-twitch fibers) when subjected to light (20-30 repetition maximum) and heavy (6-10 repetition maximum) load plantarflexion exercise.
METHODS


The study employed a within-subject design whereby 26 untrained young men had their lower limbs randomized to perform plantarflexion with a low-load (LIGHT) and a high-load (HEAVY) for 8 weeks. Muscle thickness was estimated via B-mode ultrasound and maximal strength was determined by isometric dynamometry.
RESULTS


Results showed that changes in muscle thickness were similar for the soleus and the gastrocnemius regardless of the magnitude of load used in training. Furthermore, each of the calf muscles demonstrated robust hypertrophy, with the lateral gastrocnemius showing greater gains compared to the medial gastrocnemius and soleus. Both HEAVY and LIGHT training programs elicited similar hypertrophic increases in the triceps surae. Finally, isometric strength increases were similar between loading conditions.
CONCLUSIONS


The triceps surae muscles respond robustly to regimented exercise and measures of muscle hypertrophy and isometric strength appear independent of muscle fiber type composition. Moreover, the study provides further evidence that low-load training is a viable strategy to increase hypertrophy in different human muscles, with hypertrophic increases similar to that observed using heavy loads.",2020,The triceps surae muscles respond robustly to regimented exercise and measures of muscle hypertrophy and isometric strength appear independent of muscle fiber type composition.,['26 untrained young men had their lower limbs randomized to'],"['HEAVY and LIGHT training', 'perform plantarflexion with a low-load (LIGHT) and a high-load (HEAVY']","['isometric strength increases', 'hypertrophic increases in the triceps surae', 'Muscle thickness', 'muscle thickness']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",26.0,0.0208311,The triceps surae muscles respond robustly to regimented exercise and measures of muscle hypertrophy and isometric strength appear independent of muscle fiber type composition.,"[{'ForeName': 'Brad J', 'Initials': 'BJ', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Health Sciences, CUNY Lehman College, Bronx, NY, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Vigotsky', 'Affiliation': 'Departments of Biomedical Engineering and Statistics, Northwestern University, Evanston, IL, USA.'}, {'ForeName': 'Jozo', 'Initials': 'J', 'LastName': 'Grgic', 'Affiliation': 'Institute for Health and Sport (IHES), Victoria University, Melbourne, VIC, Australia.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Haun', 'Affiliation': 'Department of Exercise Science, LaGrange College, LaGrange, GA, USA.'}, {'ForeName': 'Bret', 'Initials': 'B', 'LastName': 'Contreras', 'Affiliation': 'Sport Performance Research Institute, AUT University, Auckland, New Zealand.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Delcastillo', 'Affiliation': 'Department of Health Sciences, CUNY Lehman College, Bronx, NY, USA.'}, {'ForeName': 'Aston', 'Initials': 'A', 'LastName': 'Francis', 'Affiliation': 'Department of Health Sciences, CUNY Lehman College, Bronx, NY, USA.'}, {'ForeName': 'Gilda', 'Initials': 'G', 'LastName': 'Cote', 'Affiliation': 'Department of Health Sciences, CUNY Lehman College, Bronx, NY, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Alto', 'Affiliation': 'Department of Health Sciences, CUNY Lehman College, Bronx, NY, USA.'}]",Physiological reports,['10.14814/phy2.14427']
22,32345650,Using the BRAVO Risk Engine to Predict Cardiovascular Outcomes in Clinical Trials With Sodium-Glucose Transporter 2 Inhibitors.,"OBJECTIVE


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


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


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


The BRAVO risk engine was effective in predicting the benefits of SGLT2is on cardiovascular health through improvements in commonly measured risk factors, including A1C, SBP, and BMI. Since these benefits are individually small, the use of the complex, dynamic BRAVO model is ideal to explain the cardiovascular outcome trial results.",2020,"The BRAVO risk engine was effective in predicting the benefits of SGLT2is on cardiovascular health through improvements in commonly measured risk factors, including A1C, SBP, and BMI.","['patients with type 2 diabetes', 'Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME']","['BI 10773 (Empagliflozin', 'placebo', 'sodium-glucose cotransporter 2 inhibitors (SGLT2is']","['mortality and angina', 'Canagliflozin Cardiovascular Assessment Study (CANVAS), and Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction', 'A1C, SBP, and BMI', 'risk factors of interest (A1C, systolic blood pressure [SBP], LDL, or BMI) on cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0208940', 'cui_str': 'REG1A protein, human'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C3490349', 'cui_str': 'BI 10773'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",,0.0433696,"The BRAVO risk engine was effective in predicting the benefits of SGLT2is on cardiovascular health through improvements in commonly measured risk factors, including A1C, SBP, and BMI.","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Shao', 'Affiliation': 'Department of Pharmaceutical Outcomes and Policy, University of Florida College of Pharmacy, Gainesville, FL.'}, {'ForeName': 'Lizheng', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Tulane University School of Public Health and Tropical Medicine, New Orleans, LA.'}, {'ForeName': 'Vivian A', 'Initials': 'VA', 'LastName': 'Fonseca', 'Affiliation': 'Tulane University School of Medicine, New Orleans, LA vfonseca@tulane.edu.'}]",Diabetes care,['10.2337/dc20-0227']
23,32348882,Acceptability of an orodispersible film compared to syrup in neonates and infants: A randomized controlled trial.,"OBJECTIVES


Reliable pediatric pharmacotherapy in all age groups requires the availability of age-appropriate drug administration. Orodispersible films (ODF) are a promising pediatric oral dosage form. ODFs would meet relevant targets: one dosage form matching the full range of pediatric patients, a minimum of non-toxic excipients, a stable drug formulation easily to be produced. However, there is a lack of reliable data on ODFs' acceptability, swallowability and palatability, especially in young children. The primary objective was to demonstrate non-inferiority in acceptability of a drug-free ODF in comparison to glucose syrup in children aged below one year. Secondary objectives were swallowability and palatability of the two formulations.
STUDY DESIGN


The study was performed in an open, randomized, two-way cross-over design with three age groups: 2-28 days, 29 days-5 months, 6-12 months. 150 children (N = 50 per age group) were randomized to the order of receiving the ODF (2 × 3 cm) and age-adapted amounts of glucose syrup (0.5-3 mL). Deglutition and swallowing were assessed according to predefined evaluation criteria. The application of the formulations was documented by video to evaluate the palatability.
RESULTS


The primary objective was confirmed: Non-inferiority of the acceptability of an ODF compared to syrup was demonstrated, even superiority of the ODF was shown (p < 0.0001). The secondary endpoints demonstrated positive results including the superior swallowability of the ODF in comparison to syrup (p < 0.0001). The palatability assessments were in favor of the ODF.
CONCLUSION


ODFs are a promising and safe alternative to liquid formulations, even for children of very young ages.",2020,The secondary endpoints demonstrated positive results including the superior swallowability of the ODF in comparison to syrup,"['young children', '150 children (N=50 per age group', 'children of very young ages', 'children aged below one year', 'Neonates and Infants']","['syrup', 'Orodispersible films (ODF', 'Orodispersible Film Compared to Syrup', 'ODF (2 x 3 cm) and age-adapted amounts of glucose syrup']","['swallowability and palatability of the two formulations', 'palatability assessments', 'ODFś acceptability, swallowability and palatability', 'Deglutition and swallowing', 'inferiority of the acceptability of an ODF', 'superior swallowability of the ODF']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0458173', 'cui_str': 'Syrup'}, {'cui': 'C2960191', 'cui_str': 'Orodispersible film'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]","[{'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C2960191', 'cui_str': 'Orodispersible film'}, {'cui': 'C1282910', 'cui_str': 'Upper'}]",150.0,0.101292,The secondary endpoints demonstrated positive results including the superior swallowability of the ODF in comparison to syrup,"[{'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Klingmann', 'Affiliation': ""Department of General Pediatrics, Neonatology and Pediatric Cardiology, University Children's Hospital, Medical Faculty, Heinrich-Heine-University, Moorenstrasse 5, 40225 Düsseldorf, Germany. Electronic address: Viviane.klingmann@med.uni-duesseldorf.de.""}, {'ForeName': 'Christoph Emanuel', 'Initials': 'CE', 'LastName': 'Pohly', 'Affiliation': ""Department of General Pediatrics, Neonatology and Pediatric Cardiology, University Children's Hospital, Medical Faculty, Heinrich-Heine-University, Moorenstrasse 5, 40225 Düsseldorf, Germany.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Meissner', 'Affiliation': ""Department of General Pediatrics, Neonatology and Pediatric Cardiology, University Children's Hospital, Medical Faculty, Heinrich-Heine-University, Moorenstrasse 5, 40225 Düsseldorf, Germany.""}, {'ForeName': 'Ertan', 'Initials': 'E', 'LastName': 'Mayatepek', 'Affiliation': ""Department of General Pediatrics, Neonatology and Pediatric Cardiology, University Children's Hospital, Medical Faculty, Heinrich-Heine-University, Moorenstrasse 5, 40225 Düsseldorf, Germany.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Möltner', 'Affiliation': 'Center of Excellence for Assessment in Medicine, Medical Faculty, University Heidelberg, Im Neuenheimer Feld 346, 69120 Heidelberg, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Flunkert', 'Affiliation': 'M.A.R.C.O. Institute for Clinical Research and Statistics, Schirmerstrasse 71, 40211 Düsseldorf, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Breitkreutz', 'Affiliation': 'Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University, Universitätsstrasse 1, 40225 Düsseldorf, Germany.'}, {'ForeName': 'Hans Martin', 'Initials': 'HM', 'LastName': 'Bosse', 'Affiliation': ""Department of General Pediatrics, Neonatology and Pediatric Cardiology, University Children's Hospital, Medical Faculty, Heinrich-Heine-University, Moorenstrasse 5, 40225 Düsseldorf, Germany.""}]",European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V,['10.1016/j.ejpb.2020.03.018']
24,32352666,[Multi- and single-port laparoscopic surgery in the treatment of hydatid liver disease].,"OBJECTIVE


To compare the effectiveness of multi-port and single-port laparoscopic surgery in the treatment of hydatid cyst of the liver.
MATERIAL AND METHODS


There were 25 children with solitary hydatid cyst of the liver (CL-CE2) who underwent surgery in 2013-2017. Mean age was 10.1±2.05 years. There were 17 boys and 8 girls. Patients were divided into 2 groups: group 1 (multi-port laparoscopy) - 19 patients, group 2 (single-port laparoscopic surgery) - 6 patients.
RESULTS


Duration of ultrasound-assisted laparoscopy (G11 generator) was significantly shorter in the group 1 compared with group 2 (62.2±5.4 vs. 85.3±9.7 min,  p <0.05). Intraoperative complications were absent. Biliary fistula in postoperative period was observed in 1 (5.3%) patient of the group 1. External drainage was effective. Residual cavity in 6 months after laparoscopic resection was observed in 1 (16.7%) patient of the group 2. Recurrent liver echinococcosis was not recorded.
CONCLUSION


Hydatid cyst (CL-CE2) of the liver is an indication for laparoscopic echinococcectomy. Multi-port laparoscopy is characterized by reduced duration of surgery and postoperative morbidity compared with single-port procedures.",2020,Residual cavity in 6 months after laparoscopic resection was observed in 1 (16.7%) patient of the group 2.,"['hydatid cyst of the liver', 'There were 25 children with solitary hydatid cyst of the liver (CL-CE2) who underwent surgery in 2013-2017', 'hydatid liver disease', '17 boys and 8 girls']","['Multi-port laparoscopy', 'Multi- and single-port laparoscopic surgery', 'group 1 (multi-port laparoscopy) - 19 patients, group 2 (single-port laparoscopic surgery) - 6 patients', 'multi-port and single-port laparoscopic surgery']","['duration of surgery and postoperative morbidity', 'Intraoperative complications', 'Biliary fistula in postoperative period', 'Residual cavity', 'Duration of ultrasound-assisted laparoscopy (G11 generator', 'Recurrent liver echinococcosis']","[{'cui': 'C0013502', 'cui_str': 'Echinococcosis'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0664101', 'cui_str': 'cerium (IV) sulfate'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0005417', 'cui_str': 'Fistula of bile duct'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0237638', 'cui_str': 'Generator'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0013502', 'cui_str': 'Echinococcosis'}]",25.0,0.0730906,Residual cavity in 6 months after laparoscopic resection was observed in 1 (16.7%) patient of the group 2.,"[{'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Minaev', 'Affiliation': 'Stavropol State Medical University of the Ministry of Health of Russia, Department of Pediatric Surgery with the course of APE, Stavropol, Russia.'}, {'ForeName': 'I N', 'Initials': 'IN', 'LastName': 'Gerasimenko', 'Affiliation': 'Stavropol State Medical University of the Ministry of Health of Russia, Department of Pediatric Surgery with the course of APE, Stavropol, Russia.'}, {'ForeName': 'I V', 'Initials': 'IV', 'LastName': 'Kirgizov', 'Affiliation': 'Russian Medical Academy for Continuing Professional Education of the Ministry of Health of Russia, Department of Pediatric Surgery, Moscow, Russia.'}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Grigorova', 'Affiliation': 'Stavropol State Medical University of the Ministry of Health of Russia, Department of Pediatric Surgery with the course of APE, Stavropol, Russia.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Rubanova', 'Affiliation': 'Stavropol State Medical University of the Ministry of Health of Russia, Department of Pediatric Surgery with the course of APE, Stavropol, Russia.'}]",Khirurgiia,['10.17116/hirurgia202004137']
25,32352676,[Evaluation of advantages of Contractubex gel usage for postsurgical scars treatment in comparison with absence of systematized topical scars treatment of kids with congenital cleft lip and palate].,"OBJECTIVE


Is to evaluate the advantage of Contractubex gel with regards to influence on vascularisation, pigmentation, thickness, surface size, configuration, and elisticity of postsurgical scars of children (after cheilorinoplasty) in comparison to absence of systematized topical treatment.
MATERIAL AND METHODS


Into the prospective, non-interventional, observational, multi-centered, in parallel groups, open, controlled study were included 60 patients aged 2,5 months and older with postsurgical scars after first cheilorinoplasty after 7-14 day after operation. Patients were randomized into 2 groups of 30 patients in each. I group - patients get applications of Contractubex gel 3 times a day (in the morning, in the afternoon, in the evening) in accordance with patient information leaflet. II group - control group with no regular therapy of of postsurgical scars (without treatment or without application of oils and gels with anticsarring action). The period of medicine usage - 9 months and more for each patient, the each patient observation duration is 18 months.
RESULTS


After analysis of the primary as well as secondary efficacy criteria (total grade based on POSAS scale, reported by investigator/parent) after 3, 6, 12, 18 months of observation in both groups a positive statistically significant dynamics was registered. At the same time in the Contractubex group results were statistically significantly better than in the control group. Positive dynamics was achieved quickier in the main group than in the contol group and was to observe already after 3 months of therapy, during the whole treatment and observation phase, and after 18 months of therapy. Additionally conducted photodocumentation of postsurgical scar development dynamics in terms of the study confirms positive effect of surgery and absence of visual data regarding keloids or hyperthrophic scars formation in patients in both groups. Adverse events, i. a. pain, itch, burning, long-run hyperemia were not registered during the whole period os study.
CONCLUSION


The conducted study has shown high efficacy and safety of Contractubex usage for the treatment of postsurgical scars of children with with congenital cleft lip and palate (from 2,5 months old). The statistically significant advantage of the therapy with Contractubex was demonstrated in comparison with the control group (with no regular topical treatment). The obtained results allow to recommend Contractubex gel as an effective and safe medicine for the treatment of scarring after surgeries for kids directly after sutures removal.",2020,"Positive dynamics was achieved quickier in the main group than in the contol group and was to observe already after 3 months of therapy, during the whole treatment and observation phase, and after 18 months of therapy.","['patients in both groups', 'children with with congenital cleft lip and palate (from 2,5 months old', '60 patients aged 2,5 months and older with postsurgical scars after first cheilorinoplasty after 7-14 day after operation', 'comparison with absence of systematized topical scars treatment of kids with congenital cleft lip and palate']","['control group with no regular therapy of of postsurgical scars (without treatment or without application of oils and gels with anticsarring action', 'Contractubex gel']","['secondary efficacy criteria (total grade based on POSAS scale', 'pain, itch, burning, long-run hyperemia', 'vascularisation, pigmentation, thickness, surface size, configuration, and elisticity of postsurgical scars']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1299493', 'cui_str': 'Developmental failure of fusion'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0056260', 'cui_str': 'Contractubex'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0027686', 'cui_str': 'Neovascularization'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}]",60.0,0.0273628,"Positive dynamics was achieved quickier in the main group than in the contol group and was to observe already after 3 months of therapy, during the whole treatment and observation phase, and after 18 months of therapy.","[{'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Gonchakov', 'Affiliation': 'Central clinical hospital with polyclinic of Administrative Directorate of the President of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'Yu A', 'Initials': 'YA', 'LastName': 'Merkulova', 'Affiliation': 'Central clinical hospital with polyclinic of Administrative Directorate of the President of the Russian Federation, Moscow, Russia.'}]",Khirurgiia,['10.17116/hirurgia202004188']
26,32350016,Clinical and cost-effectiveness of a diabetes education and behavioural weight management programme versus a diabetes education programme in adults with a recent diagnosis of type 2 diabetes: study protocol for the Glucose Lowering through Weight management (GLoW) randomised controlled trial.,"INTRODUCTION


People with type 2 diabetes (T2D) can improve glycaemic control or even achieve remission through weight loss and reduce their use of medication and risk of cardiovascular disease. The Glucose Lowering through Weight management (GLoW) trial will evaluate whether a tailored diabetes education and behavioural weight management programme (DEW) is more effective and cost-effective than a diabetes education (DE) programme in helping people with overweight or obesity and a recent diagnosis of T2D to lower their blood glucose, lose weight and improve other markers of cardiovascular risk.
METHODS AND ANALYSIS


This study is a pragmatic, randomised, single-blind, parallel group, two-arm, superiority trial. We will recruit 576 adults with body mass index>25 kg/m 2  and diagnosis of T2D in the past 3 years and randomise them to a tailored DEW or a DE programme. Participants will attend measurement appointments at a local general practitioner practice or research centre at baseline, 6 and 12 months. The primary outcome is 12-month change in glycated haemoglobin. The effect of the intervention on the primary outcome will be estimated and tested using a linear regression model (analysis of covariance) including randomisation group and adjusted for baseline value of the outcome and the randomisation stratifiers. Participants will be included in the group to which they were randomised, under the intention-to-treat principle. Secondary outcomes include 6-month and 12-month changes in body weight, body fat percentage, systolic and diastolic blood pressure and lipid profile; probability of achieving good glycaemic control; probability of achieving remission from diabetes; probability of losing 5% and 10% body weight and modelled cardiovascular risk (UKPDS). An intention-to-treat within-trial cost-effectiveness analysis will be conducted from NHS and societal perspectives using participant-level data. Qualitative interviews will be conducted with participants to understand why and how the programme achieved its results and how participants manage their weight after the programme ends.
ETHICS AND DISSEMINATION


Ethical approval was received from East of Scotland Research Ethics Service on 15 May 2018 (18/ES/0048). This protocol (V.3) was approved on 19 June 2019. Findings will be published in peer-reviewed scientific journals and communicated to other stakeholders as appropriate.
TRIAL REGISTRATION NUMBER


ISRCTN18399564.",2020,"The Glucose Lowering through Weight management (GLoW) trial will evaluate whether a tailored diabetes education and behavioural weight management programme (DEW) is more effective and cost-effective than a diabetes education (DE) programme in helping people with overweight or obesity and a recent diagnosis of T2D to lower their blood glucose, lose weight and improve other markers of cardiovascular risk.
","['adults with a recent diagnosis of type 2 diabetes', '576 adults with body mass index>25 kg/m 2  and diagnosis of T2D in the past 3 years and randomise them to a tailored DEW or a DE programme', 'People with type 2 diabetes (T2D', 'Participants will attend measurement appointments at a local general practitioner practice or research centre at baseline, 6 and 12 months']","['diabetes education programme', 'behavioural weight management programme (DEW', 'diabetes education (DE) programme', 'diabetes education and behavioural weight management programme']","['12-month change in glycated haemoglobin', '6-month and 12-month changes in body weight, body fat percentage, systolic and diastolic blood pressure and lipid profile; probability of achieving good glycaemic control; probability of achieving remission from diabetes; probability of losing 5% and 10% body weight and modelled cardiovascular risk (UKPDS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",576.0,0.178744,"The Glucose Lowering through Weight management (GLoW) trial will evaluate whether a tailored diabetes education and behavioural weight management programme (DEW) is more effective and cost-effective than a diabetes education (DE) programme in helping people with overweight or obesity and a recent diagnosis of T2D to lower their blood glucose, lose weight and improve other markers of cardiovascular risk.
","[{'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Ahern', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, Cambridgeshire, UK ala34@cam.ac.uk.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Woolston', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Wells', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Sharp', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Nazrul', 'Initials': 'N', 'LastName': 'Islam', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Emma Ruth', 'Initials': 'ER', 'LastName': 'Lawlor', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Robbie', 'Initials': 'R', 'LastName': 'Duschinsky', 'Affiliation': 'Primary Care Unit, Institute of Public Health, University of Cambridge School of Clinical Medicine, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Hill', 'Affiliation': 'School of Medicine, University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Doble', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Wilson', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': 'Primary Care Unit, Institute of Public Health, University of Cambridge School of Clinical Medicine, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Carly A', 'Initials': 'CA', 'LastName': 'Hughes', 'Affiliation': 'Patient and Public Involvement Representative, Fakenham Medical Practice, Fakenham, Norfolk, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Brennan', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Bostock', 'Affiliation': 'Patient and Public Involvement Representative, Kent, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Boothby', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, Cambridgeshire, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035020']
27,32378340,Changes in strength and power performance and serum hormone concentrations during 12 weeks of task-specific or strength training in conscripts.,"The purpose of this study was to investigate the effects of two different training programs on strength and power performance and serum hormone concentrations. A total of 104 male soldiers volunteered and took part in the 12-week training period with baseline, mid-, and post-measurements of body composition, muscle strength, lower and upper body power, and blood samples to determine serum hormone concentrations. The mean (±SD) age of subjects was 20 ± 1 years, height 180 ± 6 cm and body mass 72.4 ± 8.8 kg. The subjects were divided into three different training groups: soldier task-specific training (TS), strength training (ST), and control (CON). Each group had a total of 18 training sessions during the 12-week study. In the muscle strength tests, most improvements could be observed in the TS and ST groups, especially, during the first weeks of the training period. Maximal isometric leg extension force increased significantly by 7.9 ± 12.2% (p < .05) in the TS and 7.1 ± 12.6% (p < .05) in the ST groups between the PRE and MID, as well as between the PRE and POST measurements by 8.1 ± 12.4% (p < .05) in TS and 12.3 ± 15.3% (p < .01) in ST. Serum TES concentration increased significantly in TS between the PRE and MID (16.8 ± 33.9%) and PRE and POST (11.2 ± 16.7%) measurements. Serum COR concentrations decreased in TS between the MID and POST (-7.8 ± 10.9%) and PRE and POST (-11.0 ± 14.3%) measurements. Although the differences observed were rather minor in magnitude, training in the TS and ST groups led to greater improvements in muscle strength and power performance compared to the training in the CON group. The development of strength and/or power of the lower and upper body was greater in the TS and ST groups, which is crucial for warfighter's performance. Therefore, it is important to have a structured resistance-training program during military training to optimize the strength, power, and military-specific performance.",2020,"The development of strength and/or power of the lower and upper body was greater in the TS and ST groups, which is crucial for warfighter's performance.","['The mean (±SD) age of subjects was 20\xa0±\xa01\xa0years, height 180\xa0±\xa06\xa0cm and body mass 72.4\xa0±\xa08.8\xa0kg', '104 male soldiers volunteered and took part']","['soldier task-specific training (TS), strength training (ST), and control (CON', 'POST']","['Serum TES concentration', 'Maximal isometric leg extension force', 'strength and power performance and serum hormone concentrations', 'strength and/or power of the lower and upper body', 'Serum COR concentrations', 'muscle strength and power performance']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",104.0,0.0128887,"The development of strength and/or power of the lower and upper body was greater in the TS and ST groups, which is crucial for warfighter's performance.","[{'ForeName': 'Tommi', 'Initials': 'T', 'LastName': 'Ojanen', 'Affiliation': 'Finnish Defence Research Agency, Finnish Defence Forces, Järvenpää, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Kyröläinen', 'Affiliation': 'Biology of Physical Activity, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Kozharskaya', 'Affiliation': 'Biology of Physical Activity, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Keijo', 'Initials': 'K', 'LastName': 'Häkkinen', 'Affiliation': 'Biology of Physical Activity, University of Jyväskylä, Jyväskylä, Finland.'}]",Physiological reports,['10.14814/phy2.14422']
28,32348815,Addressing Chemophobia: Informational versus affect-based approaches.,"This study investigated the effect of two communication strategies (informational and affect-based) in reducing chemophobia, the irrational fear of chemicals. In an online experiment, participants (N = 448) were randomly assigned to one of three groups (""control"", ""knowledge"", or ""affect"" group). The following dependent variables were assessed: chemophobia, knowledge of basic toxicological principles, affect towards chemicals, benefit perception of the use of chemicals, and preference for natural substitutes in consumer products. The results showed that only the informational approach, which conveys knowledge of basic toxicological principles, significantly decreased chemophobia and the preference for natural substitutes in consumer products. The affect-based approach significantly increased positive affect towards chemicals and the benefit perception of their use, but did not decrease chemophobia. This suggested that the provision of relevant information about basic toxicological principles is a more effective strategy than merely addressing laypeople's affect towards chemicals to reduce chemophobia. Relevant knowledge could be taught in schools or disseminated by toxicologists and scientists who are trusted by the public.",2020,"The affect-based approach significantly increased positive affect towards chemicals and the benefit perception of their use, but did not decrease chemophobia.",['participants (N\u202f=\u202f448'],[],"['chemophobia, knowledge of basic toxicological principles, affect towards chemicals, benefit perception of the use of chemicals, and preference for natural substitutes in consumer products']",[],[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205472', 'cui_str': 'Toxicologic'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0596381', 'cui_str': 'Consumer product'}]",448.0,0.0278971,"The affect-based approach significantly increased positive affect towards chemicals and the benefit perception of their use, but did not decrease chemophobia.","[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Saleh', 'Affiliation': 'Consumer Behavior, Institute for Environmental Decisions, ETH Zurich, Universitaetstrasse 22, 8092, Zurich, Switzerland. Electronic address: rita.saleh@hest.ethz.ch.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Bearth', 'Affiliation': 'Consumer Behavior, Institute for Environmental Decisions, ETH Zurich, Universitaetstrasse 22, 8092, Zurich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Siegrist', 'Affiliation': 'Consumer Behavior, Institute for Environmental Decisions, ETH Zurich, Universitaetstrasse 22, 8092, Zurich, Switzerland.'}]",Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association,['10.1016/j.fct.2020.111390']
29,32350810,Correction to: Comparative Study to Evaluate Tolerability of Topical 5% Minoxidil Novel Formulation and Alcohol-Based Conventional Solutions in Treatment of Androgenetic Alopecia in Indian Men: Randomized Double-Blind Study.,In Methods section under Study Design and Patients.,2020,In Methods section under Study Design and Patients.,['Indian Men'],['Topical 5% Minoxidil Novel Formulation and Alcohol-Based Conventional Solutions'],['Androgenetic Alopecia'],"[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}]",,0.0800492,In Methods section under Study Design and Patients.,"[{'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Sarkar', 'Affiliation': 'Department of Dermatology, Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Vartak', 'Affiliation': 'C.L.A.I.M.S. Pvt Ltd, Mumbai, Maharashtra, India.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Acharya', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Nikhil Kumar', 'Initials': 'NK', 'LastName': 'Kursam', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Amey', 'Initials': 'A', 'LastName': 'Mane', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Suyog', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Sujeet Narayan', 'Initials': 'SN', 'LastName': 'Charugulla', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India. sujeetnc@drreddys.com.""}]",Dermatology and therapy,['10.1007/s13555-020-00381-z']
30,32354777,"Results of a prospective, mixed methods study to assess feasibility, acceptability and effectiveness of TRIumPH (Treatment and Recovery In PsycHosis): an integrated care pathway for psychosis, compared to usual treatment.","OBJECTIVES


To evaluate whether a newly developed care pathway, Treatment and Recovery In PsycHosis (TRIumPH), is feasible, acceptable and effective in meeting National Institute of Health and Care Excellence (NICE) quality standards in a timely manner.
METHODS


This is a pragmatic, non-randomised, prospective, mixed methods study comparing an implementation (TRIumPH) and comparator site (not implementing TRIumPH) across three cohorts to assess feasibility, acceptability and effectiveness of the integrated pathway.
SETTING


Early intervention in psychosis (EIP) services at two National Health Service organisations in South of England.
PARTICIPANTS


All patients accepted into EIP services between 1 June 2014 and 31 May 2017 were each followed up for 1 year within their respective cohorts.
METHODOLOGY


Quantitative data consisted of routinely collected clinical data retrieved from patient records to assess whether the implementation of TRIumPH achieved better concordance to NICE standards. These included time to access services, physical health assessments, clinical outcomes based timeliness of delivery and acute data. The controlled trial has evaluated the effect of TRIumPH (Intervention) with Care As Usual (Comparator). Qualitative measures consisted of questionnaires, interviews and focus groups to assess acceptability and satisfaction. Outcome measures were compared within the baseline, year 1 and year 2 cohorts and between the two sites. Quantitative data were statistically analysed by comparing means and proportions.
RESULTS


Time to assessment improved in the implementation site and remained within the target in comparator site. Meeting of quality standards increased substantially in the implementation site but was more variable and reached lower levels in the comparator site especially for physical health standards. Cognitive therapy for psychosis, family intervention and carer and employment support were all offered to a greater extent in the implementation site and uptake increased over the period.
CONCLUSIONS


Pathway implementation generally led to greater improvements in achievement of access and quality standards compared with comparator site.
TRIAL REGISTRATION NUMBER


UK Clinical Research Network Portfolio (19187).",2020,Meeting of quality standards increased substantially in the implementation site but was more variable and reached lower levels in the comparator site especially for physical health standards.,"['psychosis', 'PsycHosis', 'All patients accepted into EIP services between 1 June 2014 and 31 May 2017 were each followed up for 1\u2009year within their respective cohorts', 'EIP) services at two National Health Service organisations in South of England']","['Cognitive therapy', 'implementation (TRIumPH) and comparator site (not implementing TRIumPH', 'TRIumPH', 'TRIumPH (Intervention) with Care As Usual (Comparator']","['achievement of access and quality standards', 'feasibility, acceptability and effectiveness', 'time to access services, physical health assessments, clinical outcomes based timeliness of delivery and acute data', 'acceptability and satisfaction']","[{'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C1272289', 'cui_str': 'Early intervention in psychosis'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C3643615', 'cui_str': 'Triumph'}]","[{'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C3874265', 'cui_str': 'Assessment of physical health'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0990838,Meeting of quality standards increased substantially in the implementation site but was more variable and reached lower levels in the comparator site especially for physical health standards.,"[{'ForeName': 'Shanaya', 'Initials': 'S', 'LastName': 'Rathod', 'Affiliation': 'Research and Development, Southern Health NHS Foundation Trust, Southampton, UK shanayarathod@nhs.net.'}, {'ForeName': 'Kerensa', 'Initials': 'K', 'LastName': 'Thorne', 'Affiliation': 'Research and Development, Southern Health NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Graves', 'Affiliation': 'Research and Development, Southern Health NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Phiri', 'Affiliation': 'Research and Development, Southern Health NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Asher', 'Affiliation': 'Research and Development, Southern Health NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Griffiths', 'Affiliation': 'Wessex Academic Health Sciences Network, Southampton, UK.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Read', 'Affiliation': 'Dorset HealthCare NHS Foundation Trust, Poole, Poole, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kingdon', 'Affiliation': 'Medicine, University of Southampton, Southampton, UK.'}]",BMJ open,['10.1136/bmjopen-2019-033711']
31,32355959,Corticospinal-motor neuronal plasticity promotes exercise-mediated recovery in humans with spinal cord injury.,"Rehabilitative exercise in humans with spinal cord injury aims to engage residual neural networks to improve functional recovery. We hypothesized that exercise combined with non-invasive stimulation targeting spinal synapses further promotes functional recovery. Twenty-five individuals with chronic incomplete cervical, thoracic, and lumbar spinal cord injury were randomly assigned to 10 sessions of exercise combined with paired corticospinal-motor neuronal stimulation (PCMS) or sham-PCMS. In an additional experiment, we tested the effect of PCMS without exercise in 13 individuals with spinal cord injury with similar characteristics. During PCMS, 180 pairs of stimuli were timed to have corticospinal volleys evoked by transcranial magnetic stimulation over the primary motor cortex arrive at corticospinal-motor neuronal synapses of upper- or lower-limb muscles (depending on the injury level), 1-2 ms before antidromic potentials were elicited in motor neurons by electrical stimulation of a peripheral nerve. Participants exercised for 45 min after all protocols. We found that the time to complete subcomponents of the Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) and the 10-m walk test decreased on average by 20% after all protocols. However, the amplitude of corticospinal responses elicited by transcranial magnetic stimulation and the magnitude of maximal voluntary contractions in targeted muscles increased on overage by 40-50% after PCMS combined or not with exercise but not after sham-PCMS combined with exercise. Notably, behavioural and physiological effects were preserved 6 months after the intervention in the group receiving exercise with PCMS but not in the group receiving exercise combined with sham-PCMS, suggesting that the stimulation contributed to preserve exercise gains. Our findings indicate that targeted non-invasive stimulation of spinal synapses might represent an effective strategy to facilitate exercise-mediated recovery in humans with different degrees of paralysis and levels of spinal cord injury.",2020,"Notably, behavioural and physiological effects were preserved 6 months after the intervention in the group receiving exercise with PCMS but not in the group receiving exercise combined with sham-PCMS, suggesting that the stimulation contributed to preserve exercise gains.","['humans with spinal cord injury', '13 individuals with spinal cord injury with similar characteristics', 'Twenty-five individuals with chronic incomplete cervical, thoracic, and lumbar spinal cord injury']","['PCMS without exercise', 'exercise combined with paired corticospinal-motor neuronal stimulation (PCMS) or sham-PCMS', 'Corticospinal-motor neuronal plasticity promotes exercise', 'Rehabilitative exercise', 'exercise combined with sham-PCMS']","['time to complete subcomponents of the Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) and the 10-m walk test', 'behavioural and physiological effects']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0457848', 'cui_str': 'Segment of lumbar spinal cord'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]","[{'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0027880', 'cui_str': 'Plasticity, Neuronal'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.223458,"Notably, behavioural and physiological effects were preserved 6 months after the intervention in the group receiving exercise with PCMS but not in the group receiving exercise combined with sham-PCMS, suggesting that the stimulation contributed to preserve exercise gains.","[{'ForeName': 'Hang Jin', 'Initials': 'HJ', 'LastName': 'Jo', 'Affiliation': 'University of Miami, Department of Neurological Surgery, The Miami Project to Cure Paralysis, and Bruce W. Carter Department of Veterans Affairs Medical Center, Miami, FL, USA.'}, {'ForeName': 'Monica A', 'Initials': 'MA', 'LastName': 'Perez', 'Affiliation': 'University of Miami, Department of Neurological Surgery, The Miami Project to Cure Paralysis, and Bruce W. Carter Department of Veterans Affairs Medical Center, Miami, FL, USA.'}]",Brain : a journal of neurology,['10.1093/brain/awaa052']
32,32353805,"Sugammadex versus neostigmine for reversal of rocuronium-induced neuromuscular blockade: A randomized, double-blinded study of thoracic surgical patients evaluating hypoxic episodes in the early postoperative period.","STUDY OBJECTIVE


This objective of this study was to determine if reversal of rocuronium-induced neuromuscular blockade with sugammadex versus neostigmine results in a decreased number of hypoxic episodes in the early postoperative period in patients undergoing thoracic surgery with single lung ventilation.
DESIGN


Single-center, randomized, double-blind, two-arm clinical trial.
SETTING


Operating room and postanesthesia care unit.
PATIENTS


92 subjects aged ≥18, American Society of Anesthesiologists physical status II-IV, and undergoing a thoracic operation necessitating single lung ventilation.
INTERVENTIONS


Subjects received either 2 mg/kg sugammadex or 50 μg/kg neostigmine with 8 μg/kg glycopyrrolate for reversal of moderate neuromuscular blockade.
MEASUREMENTS


For the first 90 min postoperatively, all episodes of hypoxia were recorded. Neuromuscular monitoring was performed with acceleromyography (TOF-Watch® SX) and the train of four (TOF) was recorded at 2, 5, 10, and 15 min after administration of the neuromuscular reversal agent.
MAIN RESULTS


Subjects who received neostigmine had a median of 1 episode (interquartile range IQR: 0-2.2) of hypoxia versus subjects who received sugammadex who had a median of 0 episodes (IQR: 0-1) (p = 0.009). The mean time to recovery of TOF ≥ 0.9 was significantly faster with sugammadex at 10 min (95% confidence interval CI: 5-15) compared with neostigmine at 40 min (95% CI: 15-53) (p < 0.001).
CONCLUSIONS


In thoracic surgical patients necessitating single lung ventilation, sugammadex provides faster reversal of moderate neuromuscular blockade and results in a decreased number of postoperative hypoxic episodes compared with neostigmine.",2020,"The mean time to recovery of TOF ≥ 0.9 was significantly faster with sugammadex at 10 min (95% confidence interval CI: 5-15) compared with neostigmine at 40 min (95% CI: 15-53) (p < 0.001).
","['Operating room and postanesthesia care unit', 'patients undergoing thoracic surgery with single lung ventilation', '92 subjects aged ≥18, American Society of Anesthesiologists physical status II-IV, and undergoing a thoracic operation necessitating single lung ventilation', 'thoracic surgical patients evaluating hypoxic episodes in the early postoperative period', 'induced neuromuscular blockade']","['Sugammadex versus neostigmine', 'rocuronium', 'acceleromyography (TOF-Watch® SX', 'neostigmine', '2\xa0mg/kg sugammadex or 50\xa0μg/kg neostigmine with 8\xa0μg/kg glycopyrrolate', 'sugammadex versus neostigmine']","['episodes of hypoxia', 'hypoxic episodes', 'median of 1 episode', 'postoperative hypoxic episodes', 'mean time to recovery of TOF\xa0≥']","[{'cui': 'C0029064', 'cui_str': 'Operating theatre'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0524832', 'cui_str': 'Surgical procedure on thorax'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}]","[{'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C3805242', 'cui_str': 'Acceleromyography'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}]","[{'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]",92.0,0.706447,"The mean time to recovery of TOF ≥ 0.9 was significantly faster with sugammadex at 10 min (95% confidence interval CI: 5-15) compared with neostigmine at 40 min (95% CI: 15-53) (p < 0.001).
","[{'ForeName': 'Tiffany S', 'Initials': 'TS', 'LastName': 'Moon', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA. Electronic address: Tiffany.Moon@UTSouthwestern.edu.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Reznik', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Cardiovascular and Thoracic Surgery, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Pak', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Jan', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Pruszynski', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Cardiovascular and Thoracic Surgery, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Kim', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Katelynn M', 'Initials': 'KM', 'LastName': 'Smith', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Lu', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Gasanova', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Pamela E', 'Initials': 'PE', 'LastName': 'Fox', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Babatunde', 'Initials': 'B', 'LastName': 'Ogunnaike', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109804']
33,32353544,Medication treatment for opioid use disorder in expectant mothers (MOMs): Design considerations for a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations.,"Opioid use disorder (OUD) in pregnant women has increased significantly in recent years. Maintaining these women on sublingual (SL) buprenorphine (BUP) is an evidence-based practice but BUP-SL is associated with several disadvantages that an extended-release (XR) BUP formulation could eliminate. The National Drug Abuse Treatment Clinical Trials Network (CTN) is conducting an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial, Medication treatment for Opioid-dependent expectant Mothers (MOMs), to compare mother and infant outcomes of pregnant women with OUD treated with BUP-XR, relative to BUP-SL. A second aim is to determine the relative economic value of utilizing BUP-XR. Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization. Participants will be provided with study medication and attend weekly medication visits through 12 months postpartum. Participants will be invited to participate in two sub-studies to evaluate the: 1) mechanisms by which BUP-XR may improve mother and infant outcomes; and 2) effects of prenatal exposure to BUP-XR versus BUP-SL on infant neurodevelopment. This paper describes the key design decisions for the main trial made during protocol development. This Investigational New Drug (IND) trial uniquely uses pragmatic features where feasible in order to maximize external validity, hence increasing the potential to inform clinical practice guidelines and address multiple knowledge gaps for treatment of this patient population.",2020,"Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization.","['expectant mothers (MOMs', 'Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30\u202fweeks, recruited from 12 sites', 'pregnant women with OUD treated with BUP-XR, relative to BUP-SL', 'pregnant women']","['sublingual (SL) buprenorphine (BUP', 'buprenorphine formulations', 'prenatal exposure to BUP-XR versus BUP-SL']",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1442163', 'cui_str': 'MoM'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]",[],300.0,0.0591114,"Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization.","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Lofwall', 'Affiliation': 'Departments of Behavioral Science and Psychiatry, University of Kentucky College of Medicine, Center on Drug and Alcohol Research, 845 Angliana Avenue, Lexington, KY 40508, USA.'}, {'ForeName': 'Hendrée E', 'Initials': 'HE', 'LastName': 'Jones', 'Affiliation': 'UNC Horizons and Department of Obstetrics and Gynecology, University of North Carolina Chapel Hill, 410 North Greensboro St., Carrboro, NC 27510, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lindblad', 'Affiliation': 'The Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.'}, {'ForeName': 'Davida M', 'Initials': 'DM', 'LastName': 'Schiff', 'Affiliation': 'Division of General Academic Pediatrics, MassGeneral Hospital for Children, 125 Nashua St Suite 860, Boston, MA 02114, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Wexelblatt', 'Affiliation': ""Perinatal Institute, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229, USA; Department of Pediatrics, University of Cincinnati College of Medicine, 3230 Eden Avenue, Cincinnati, OH 45229, USA.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Merhar', 'Affiliation': ""Perinatal Institute, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229, USA; Department of Pediatrics, University of Cincinnati College of Medicine, 3230 Eden Avenue, Cincinnati, OH 45229, USA.""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medical College, 425 East 61st Street Suite 301, New York, NY 10065, USA.'}, {'ForeName': 'Shelly F', 'Initials': 'SF', 'LastName': 'Greenfield', 'Affiliation': ""Department of Psychiatry, Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, USA; Division of Alcohol, Drug and Addictions and the Division of Women's Mental Health, McLean Hospital, 115 Mill Street, Belmont, MA 02478, USA.""}, {'ForeName': 'Mishka', 'Initials': 'M', 'LastName': 'Terplan', 'Affiliation': 'Friends Research Institute,1040 Park Ave Suite 103, Baltimore, MD 21201, USA.'}, {'ForeName': 'Elisha M', 'Initials': 'EM', 'LastName': 'Wachman', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, 801 Albany Street, Boston, MA 02119, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'The Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.'}, {'ForeName': 'Abigail G', 'Initials': 'AG', 'LastName': 'Matthews', 'Affiliation': 'The Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Guille', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Medical University of South Carolina, 67 President St., MSC 861, Charleston, SC 29425, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverstein', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, Boston University School of Medicine, 88 East Newton Street, Boston, MA 02118, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Rosa', 'Affiliation': 'Center for the Clinical Trials Network, National Institute on Drug Abuse, 6001 Executive Blvd, Bethesda, MD 20892, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106014']
34,32354780,Study protocol for a prospective randomised double-blind placebo-controlled clinical trial investigating a Better Outcome with Melatonin compared to Placebo Administered to normalize sleep-wake cycle and treat hypoactive ICU Delirium: the Basel BOMP-AID study.,"INTRODUCTION


Delirium is frequently observed in the intensive care unit (ICU) population, in particular. Until today, there is no evidence for any reliable pharmacological intervention to treat delirium. The Basel BOMP-AID ( B etter  O utcome with  M elatonin compared to  P lacebo  A dministered to normalize sleep-wake cycle and treat hypoactive  I CU  D elirium) randomised trial targets improvement of hypoactive delirium therapy in critically ill patients and will be conducted as a counterpart to the Basel ProDex Study (Study Protocol, BMJ Open, July 2017) on hyperactive and mixed delirium. The aim of the BOMP-AID trial is to assess the superiority of melatonin to placebo for the treatment of hypoactive delirium in the ICU. The study hypothesis is based on the assumption that melatonin administered at night restores a normal circadian rhythm, and that restoration of a normal circadian rhythm will cure delirium.
METHODS AND ANALYSIS


The Basel BOMP-AID study is an investigator-initiated, single-centre, randomised controlled clinical trial for the treatment of hypoactive delirium with the once daily oral administration of melatonin 4 mg versus placebo in 190 critically ill patients. The primary outcome measure is delirium duration in 8-hour shifts. Secondary outcome measures include delirium-free days and death at 28 days after study inclusion, number of ventilator days, length of ICU and hospital stay, and sleep quality. Patients will be followed after 3 and 12 months for activities of daily living and mortality assessment. Sample size was calculated to demonstrate superiority of melatonin compared with placebo regarding the duration of delirium. Results will be presented using an intention-to-treat approach.
ETHICS AND DISSEMINATION


This study has been approved by the Ethics Committee of Northwestern and Central Switzerland and will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki, the International Conference on Harmonisation (ICH) of technical requirements for registration of pharmaceuticals for human use; Good Clinical Practice (GCP) or ISO EN 14155 (as far as applicable), as well as all national legal and regulatory requirements. Study results will be presented in international conferences and published in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


NCT03438526.
PROTOCOL VERSION


Clinical Study Protocol Version 3, 10.03.2019.",2020,Sample size was calculated to demonstrate superiority of melatonin compared with placebo regarding the duration of delirium.,"['190 critically ill patients', 'critically ill patients']","['Placebo', 'placebo', 'melatonin 4\u2009mg versus placebo', 'O utcome with  M elatonin', 'Melatonin', 'melatonin to placebo', 'melatonin', 'hypoactive delirium therapy']","['Basel BOMP-AID ( B etter', 'activities of daily living and mortality assessment', 'delirium-free days and death at 28 days after study inclusion, number of ventilator days, length of ICU and hospital stay, and sleep quality', 'delirium duration in 8-hour shifts', 'duration of delirium']","[{'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C3203501', 'cui_str': 'Hypoactive delirium'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0053926', 'cui_str': 'BOMP protocol'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0333051', 'cui_str': 'Shift'}]",190.0,0.483933,Sample size was calculated to demonstrate superiority of melatonin compared with placebo regarding the duration of delirium.,"[{'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Hollinger', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Basel, Switzerland alexa.hollinger@usb.ch.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'von Felten', 'Affiliation': 'Department of Clinical Research, Clinical Trial Unit, c/o University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Sutter', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Huber', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Tran', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Reinhold', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Abdelhamid', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Atanas', 'Initials': 'A', 'LastName': 'Todorov', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Caroline Eva', 'Initials': 'CE', 'LastName': 'Gebhard', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Cajochen', 'Affiliation': 'Faculty of Medicine, University of Basel, Basel, BS, Switzerland.'}, {'ForeName': 'Luzius A', 'Initials': 'LA', 'LastName': 'Steiner', 'Affiliation': 'Faculty of Medicine, University of Basel, Basel, BS, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Siegemund', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Basel, Switzerland.'}]",BMJ open,['10.1136/bmjopen-2019-034873']
35,32358353,"The effect of lung-conduction exercise in chronic obstructive pulmonary disease: Study protocol for randomized, assessor-blind, multicenter trial.","BACKGROUND


Chronic obstructive pulmonary disease (COPD) is an irreversible disease characterized by cough, sputum production, and dyspnea, and has a high prevalence and mortality. Pulmonary rehabilitation (PR) is a management that improves the quality of life for COPD patients; however, PR is not readily accessible. Therefore, we developed lung-conduction exercises (LCE) that can be performed without any limitations. LCE consists of breathing, stretching, and tapping to relieve dyspnea in COPD patients.
METHODS/DESIGN


This randomized, assessor-blind, multicenter trial aims to recruit 54 patients with moderate and severe COPD. Subjects will be randomly allocated to a control group (only medication), an LCE group (medication + LCE, 5 times a week), or a PR group (medication + PR, 5 times a week). The 6-minute walk distance, pulmonary function tests (forced expiratory volume at 1 second, forced vital capacity, and forced expiratory volume at 1 second/forced vital capacity), modified Borg scale, modified medical research council dyspnea scale, COPD assessment test, and St. George respiratory questionnaire will be measured before starting the trial and after the 4th and 8th weeks to determine motor performance, lung function, and dyspnea.
CONCLUSION


We aim to demonstrate that LCE is effective in improving symptoms and psychosomatic stability in COPD patients. Therefore, this trial will play an important role in fortifying the foundation of clinical application.",2020,"The 6-minute walk distance, pulmonary function tests (forced expiratory volume at 1 second, forced vital capacity, and forced expiratory volume at 1 second/forced vital capacity), modified Borg scale, modified medical research council dyspnea scale, COPD assessment test, and St. George respiratory questionnaire will be measured before starting the trial and after the 4th and 8th weeks to determine motor performance, lung function, and dyspnea.
","['Chronic obstructive pulmonary disease (COPD', 'chronic obstructive pulmonary disease', '54 patients with moderate and severe COPD', 'COPD patients']","['lung-conduction exercise', 'LCE group (medication + LCE', 'lung-conduction exercises (LCE', 'LCE', 'Pulmonary rehabilitation (PR', 'control group (only medication']","['quality of life', 'motor performance, lung function, and dyspnea', '6-minute walk distance, pulmonary function tests (forced expiratory volume at 1 second, forced vital capacity, and forced expiratory volume at 1 second/forced vital capacity), modified Borg scale, modified medical research council dyspnea scale, COPD assessment test, and St. George respiratory questionnaire']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0232217', 'cui_str': 'Cardiac conduction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449399', 'cui_str': 'Borg scale'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",54.0,0.0922195,"The 6-minute walk distance, pulmonary function tests (forced expiratory volume at 1 second, forced vital capacity, and forced expiratory volume at 1 second/forced vital capacity), modified Borg scale, modified medical research council dyspnea scale, COPD assessment test, and St. George respiratory questionnaire will be measured before starting the trial and after the 4th and 8th weeks to determine motor performance, lung function, and dyspnea.
","[{'ForeName': 'Su Won', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, College of Korean Medicine, Daejeon University.'}, {'ForeName': 'Yee Ran', 'Initials': 'YR', 'LastName': 'Lyu', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, College of Korean Medicine, Daejeon University.'}, {'ForeName': 'So Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Clinical Trial Center, Daejeon Korean Medicine Hospital of Daejeon University.'}, {'ForeName': 'Jin Young', 'Initials': 'JY', 'LastName': 'Kwak', 'Affiliation': 'Clinical Trial Center, Daejeon Korean Medicine Hospital of Daejeon University.'}, {'ForeName': 'Won Kyung', 'Initials': 'WK', 'LastName': 'Yang', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, College of Korean Medicine, Daejeon University.'}, {'ForeName': 'Seung Hyung', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Institute of Traditional Medicine and Bioscience.'}, {'ForeName': 'Weechang', 'Initials': 'W', 'LastName': 'Kang', 'Affiliation': 'Department of Statistics, Hyehwa Liberal Arts College, Daejeon University.'}, {'ForeName': 'Ji Woong', 'Initials': 'JW', 'LastName': 'Son', 'Affiliation': 'Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, Konyang University Hospital.'}, {'ForeName': 'In Chul', 'Initials': 'IC', 'LastName': 'Jung', 'Affiliation': 'Clinical Trial Center, Daejeon Korean Medicine Hospital of Daejeon University.'}, {'ForeName': 'Yang Chun', 'Initials': 'YC', 'LastName': 'Park', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, College of Korean Medicine, Daejeon University.'}]",Medicine,['10.1097/MD.0000000000019826']
36,32358357,Consolidation period of 18 months no better at promoting off-treatment durability in HBeAg-positive chronic hepatitis B patients with tenofovir disoproxil fumarate treatment than a 12-month period: A prospective randomized cohort study.,"There has been no clear consensus on the optimal consolidation periods following HBeAg seroconversion (SC) in HBeAg-positive chronic hepatitis B (CHB) patients. Our study aimed to prospectively compare relapse rates between 12 months' and 18 months' consolidation periods to see whether or not there is beneficial durability of tenofovir disoproxil fumarate (TDF) therapy with longer consolidation periods.We enrolled a total of 137 HBeAg-positive Asian CHB patients treated with TDF monotherapy. Forty-six patients achieved HBeAg SC. Then, they were randomly assigned to consolidation period of either 12 months (group A) or 18 months (group B). After stopping TDF therapy, all patients were followed up for 12 months.Thirteen patients (56.5%) relapsed in group A and 12 patients (52.2%) relapsed in group B after 12 months' follow-up (P = .958). Pretreatment HBsAg level is the only significant predictor for off-therapy recurrence by univariate analysis (P = .024). Baseline HBeAg >1000 S/CO in group B patients were significantly less likely to relapse than those of group A (P = .046). Baseline alanine aminotransferase (ALT) >133 U/L could significantly predict occurrence of HBeAg SC (P = .008; 95% CI: 0.545-0.763; AUC: 0.654).Overall, a prolonged consolidation period has no positive effect on TDF therapy on sustained viral suppression in HBeAg-positive Asian CHB patients. However, a prolonged consolidation period was beneficial to patients with high baseline semi-quantitative HBeAg levels in terms of off-treatment durability. Baseline ALT > 133 U/L could significantly predict the occurrence of HBeAg SC.",2020,Pretreatment HBsAg level is the only significant predictor for off-therapy recurrence by univariate analysis (P = .024).,"['137 HBeAg-positive Asian CHB patients treated with', 'HBeAg-positive chronic hepatitis B patients with']","['tenofovir disoproxil fumarate (TDF) therapy', 'TDF therapy', 'TDF monotherapy', 'tenofovir disoproxil fumarate']","['HBeAg SC', 'Baseline HBeAg', 'relapse rates', 'occurrence of HBeAg SC', 'Baseline alanine aminotransferase (ALT']","[{'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}]",,0.0771693,Pretreatment HBsAg level is the only significant predictor for off-therapy recurrence by univariate analysis (P = .024).,"[{'ForeName': 'Chun-Hsiang', 'Initials': 'CH', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatogastroenterology, Tainan Municipal Hospital (Managed by Show Chwan Medical Care Corporation), Tainan.'}, {'ForeName': 'Kuo-Kuan', 'Initials': 'KK', 'LastName': 'Chang', 'Affiliation': 'Department of Hepatogastroenterology, Tainan Municipal Hospital (Managed by Show Chwan Medical Care Corporation), Tainan.'}, {'ForeName': 'Ruey-Chang', 'Initials': 'RC', 'LastName': 'Lin', 'Affiliation': 'Department of Hepatogastroenterology, Tainan Municipal Hospital (Managed by Show Chwan Medical Care Corporation), Tainan.'}, {'ForeName': 'Ming-Jeng', 'Initials': 'MJ', 'LastName': 'Kuo', 'Affiliation': 'Department of Hepatogastroenterology, Tainan Municipal Hospital (Managed by Show Chwan Medical Care Corporation), Tainan.'}, {'ForeName': 'Chi-Chieh', 'Initials': 'CC', 'LastName': 'Yang', 'Affiliation': 'Department of Hepatogastroenterology, Show Chwan Memorial Hospital, Changhua.'}, {'ForeName': 'Yuan-Tsung', 'Initials': 'YT', 'LastName': 'Tseng', 'Affiliation': 'Committee of Medical Research, Tainan Municipal Hospital (Managed by Show Chwan Medical Care Corporation), Tainan, Taiwan.'}]",Medicine,['10.1097/MD.0000000000019907']
37,32349629,Resistance training with blood flow restriction: Impact on the muscle strength and body composition in people living with HIV/AIDS.,"The aim of the study was to compare the impact of 12-week resistance training with blood flow restriction (G RTBFR ) versus, traditional resistance training (G TRT ) and non-training on the muscle strength and body composition HIV/AIDS participants. Muscle strength was tested at baseline, and on the 6th, 21st and 36th training sessions, using maximal repetition test. Pre- and post-intervention body composition changes were measured by dual-energy X-ray absorptiometry. Resistance training was undertaken three times a week comprising bilateral elbow extension and flexion exercises, unilateral flexion and bilateral knee extension. Changes in strength and body composition (pre- and post-intervention) between groups were evaluated by mixed models of repeated measures, and by paired and unpaired comparisons, considering the Effect Size. All groups were similar at baseline for muscle strength and body composition. Post-intervention, the training groups showed similar, statistically significant increases in muscle strength (G RTBFR =25.7-57.4%; G TRT= 24.5-52.3%) and skeletal muscle tissue (G RTBFR =8.4%; G TRT =8.3%). There was also a significant change in body fat ( p =0.023-0.043), with significant effect sizes for strength and skeletal muscle tissue (0.41-2.27), respectively. These results suggest that both resistance training interventions promoted muscle hypertrophy, body fat reduction and positive impact on muscle strength in people living with HIV/AIDS. Resistance training with blood flow restriction proved to be an effective alternative to include patients with marked physical weakness, unable to engage in regular strength training programme.ClinicalTrials.gov identifier: NCT02783417.",2020,"Resistance training with blood flow restriction proved to be an effective alternative to include patients with marked physical weakness, unable to engage in regular strength training program.","['people living with HIV/AIDS', 'patients with marked physical weakness']","['Resistance training with blood flow restriction', 'resistance training with blood flow restriction (G RTBFR ', 'bilateral elbow extension and flexion exercises, unilateral flexion and bilateral knee extension', 'traditional resistance training (G TRT ) and non-training']","['Muscle strength', 'skeletal muscle tissue', 'muscle strength and body composition', 'muscle hypertrophy, body fat reduction and positive impact on muscle strength', 'strength and body composition', 'muscle strength', 'strength and skeletal muscle tissue', 'body fat']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3714552', 'cui_str': 'Debility'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0236033', 'cui_str': 'Muscle hypertrophy'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",,0.0174263,"Resistance training with blood flow restriction proved to be an effective alternative to include patients with marked physical weakness, unable to engage in regular strength training program.","[{'ForeName': 'Thiago Cândido', 'Initials': 'TC', 'LastName': 'Alves', 'Affiliation': 'Nursing School of Ribeirao Preto, University of Sao Paulo, Ribeirao Preto, Brazil.'}, {'ForeName': 'André P', 'Initials': 'AP', 'LastName': 'Santos', 'Affiliation': 'Nursing School of Ribeirao Preto, University of Sao Paulo, Ribeirao Preto, Brazil.'}, {'ForeName': 'Pedro P', 'Initials': 'PP', 'LastName': 'Abdalla', 'Affiliation': 'Nursing School of Ribeirao Preto, University of Sao Paulo, Ribeirao Preto, Brazil.'}, {'ForeName': 'Ana Cláudia R', 'Initials': 'ACR', 'LastName': 'Venturini', 'Affiliation': 'Nursing School of Ribeirao Preto, University of Sao Paulo, Ribeirao Preto, Brazil.'}, {'ForeName': 'Priscila S', 'Initials': 'PS', 'LastName': 'Angelotti', 'Affiliation': 'Anthropometry, Training and Sport Research and Study Group.'}, {'ForeName': 'Franciane Góes', 'Initials': 'FG', 'LastName': 'Borges', 'Affiliation': 'School of Physical Education and Sport of Ribeirao Preto, University of Sao Paulo, Ribeirao Preto, Brazil.'}, {'ForeName': 'Henrique D O', 'Initials': 'HDO', 'LastName': 'Reis', 'Affiliation': 'Medical School of Ribeirao Preto, University of Sao Paulo, Ribeirao Preto, Brazil.'}, {'ForeName': 'Valdes R', 'Initials': 'VR', 'LastName': 'Bollela', 'Affiliation': 'Medical School of Ribeirao Preto, University of Sao Paulo, Ribeirao Preto, Brazil.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Mota', 'Affiliation': 'Research Center on Physical Activity, Health and Leisure (CIAFEL), Faculty of Sport, University of Porto, Porto, Portugal.'}, {'ForeName': 'Dalmo R L', 'Initials': 'DRL', 'LastName': 'Machado', 'Affiliation': 'Nursing School of Ribeirao Preto, University of Sao Paulo, Ribeirao Preto, Brazil.'}]",European journal of sport science,['10.1080/17461391.2020.1757765']
38,32358339,The effects of green cardamom supplementation on blood pressure and endothelium function in type 2 diabetic patients: A study protocol for a randomized controlled clinical trial.,"INTRODUCTION


Cardamom possesses antioxidant, anti-inflammation, and blood pressure lowering properties, which might improve endothelial function in type 2 diabetic patients. However, no study has examined the effect of cardamom on diabetic patients. The present study aimed to examine the effects of 10-week green cardamom intake on blood pressure, concentrations of inflammatory and endothelial function biomarkers in type 2 diabetes mellitus patients, and its potential mechanisms.
METHODS AND ANALYSIS DESIGN


Eighty overweight or obese patients with type 2 diabetes mellitus (aged 30-60 years) will be recruited into the trial and will assign to receive either cardamom (3 g/day, 6 capsules) or placebo (rusk powder, 6 capsules) for a period of 10 weeks. Systolic blood pressure and diastolic blood pressure, asymmetric dimethylarginine, and nitric oxide will be measured. Serum inflammatory markers namely interleukin 6, tumor necrosis factor-α, high-sensitivity C-reactive protein, and factors related to endothelial function including intercellular adhesion molecule-1, vascular cell adhesion molecule 1, CD62 antigen-like family member E, and cluster of differentiation 163 will be measured at baseline and at the end of the trial. Sociodemographic, International Physical Activity Questionnaire, and three 24-hour dietary recall questionnaires will be collected for each participant.
ETHICS AND DISSEMINATION


The study has been approved by The Ethics Committee of Tehran University of Medical Sciences (IR.TUMS.REC.1395.2700). Each participant will sign a written informed consent at the beginning of the study. At the end of the study, results will be published timely manner.
TRIAL REGISTRATION NUMBER


(http://www.irct.ir, identifier: IRCT-2016042717254N5) Date of registration: 2016-11-23.",2020,"Serum inflammatory markers namely interleukin 6, tumor necrosis factor-α, high-sensitivity C-reactive protein, and factors related to endothelial function including intercellular adhesion molecule-1, vascular cell adhesion molecule 1, CD62 antigen-like family member E, and cluster of differentiation 163 will be measured at baseline and at the end of the trial.","['type 2 diabetes mellitus patients', 'Eighty overweight or obese patients with type 2 diabetes mellitus (aged 30-60 years', 'type 2 diabetic patients', 'diabetic patients']","['green cardamom supplementation', '10-week green cardamom intake', 'placebo']","['endothelial function', 'Systolic blood pressure and diastolic blood pressure, asymmetric dimethylarginine, and nitric oxide', 'Sociodemographic, International Physical Activity Questionnaire', 'blood pressure, concentrations of inflammatory and endothelial function biomarkers', 'blood pressure and endothelium function']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0453247', 'cui_str': 'Elettaria cardamomum'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",80.0,0.112212,"Serum inflammatory markers namely interleukin 6, tumor necrosis factor-α, high-sensitivity C-reactive protein, and factors related to endothelial function including intercellular adhesion molecule-1, vascular cell adhesion molecule 1, CD62 antigen-like family member E, and cluster of differentiation 163 will be measured at baseline and at the end of the trial.","[{'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Ghazi Zahedi', 'Affiliation': 'Department of Community Nutrition.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Koohdani', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Qorbani', 'Affiliation': 'Noncommunicable Diseases Research Center, Endocrinology and Metabolism Population Sciences Institute, Tehran University of Medical Sciences, School of Medicine, Alborz University of Medical Sciences, Baghestan Boulevard, Karaj.'}, {'ForeName': 'Fereydoun', 'Initials': 'F', 'LastName': 'Siassi', 'Affiliation': 'Department of Community Nutrition.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Keshavarz', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics.'}, {'ForeName': 'Ensieh', 'Initials': 'E', 'LastName': 'Nasli-Esfahani', 'Affiliation': 'Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohadeseh', 'Initials': 'M', 'LastName': 'Aghasi', 'Affiliation': 'Department of Community Nutrition.'}, {'ForeName': 'Hoorieh', 'Initials': 'H', 'LastName': 'Khoshamal', 'Affiliation': 'Department of Community Nutrition.'}, {'ForeName': 'Gity', 'Initials': 'G', 'LastName': 'Sotoudeh', 'Affiliation': 'Department of Community Nutrition.'}]",Medicine,['10.1097/MD.0000000000011005']
39,32356416,Influence of Besifovir Dipivoxil Maleate Combined with L-Carnitine on Hepatic Steatosis in Patients with Chronic Hepatitis B.,"BACKGROUND


Besifovir dipivoxil maleate (BSV) with L-carnitine is the first-line antiviral agent for chronic hepatitis B (CHB) infection. We investigated whether BSV combined with L-carnitine improves hepatic steatosis (HS).
METHODS


Treatment-naïve patients with CHB who were initiated on antiviral therapy (AVT) were enrolled. The magnitude of HS was assessed using hepatic steatosis index (HSI), and HS improvement was defined as a ≥ 10% reduction in the HSI score from the baseline.
RESULTS


The mean age of the study patients was 56 years with a male predominance (n = 178, 64.7%). The mean body mass index (BMI), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and platelet count were 23.5 kg/m², 49.6 IU/L, 49.0 IU/L, and 191.3 × 10⁹/L, respectively. The mean HSI and fibrosis (FIB)-4 index were 32.6 and 0.5, respectively. After 6 months of AVT, platelet count (mean, 191.3→167.0 × 10⁹/L), fasting glucose (mean, 113.1→105.9 mg/dL), AST (mean, 49.6→28.0 IU/L), ALT (mean, 49.0→33.9 IU/L), and total cholesterol (mean, 170.0→162.1 mg/dL) levels significantly decreased (all  P  < 0.05). In the BSV group, AST (mean, 95.2→30.2 IU/L) and ALT (mean, 81.1→31.1 IU/L) levels significantly reduced (all  P  < 0.05), whereas HSI and FIB-4 index were maintained (all  P  > 0.05). In the univariate analysis, age, BMI, diabetes, cirrhosis, fasting glucose level, and ALT were significantly associated with HS improvement (all  P  < 0.05).
CONCLUSION


BSV with L-carnitine did not show any improvement of HS in patients with CHB. Further prospective randomized controlled studies are needed to validate the potential beneficial effects of BSV with L-carnitine in CHB infection.",2020,"In the BSV group, AST (mean, 95.2→30.2 IU/L) and ALT (mean, 81.1→31.1 IU/L) levels significantly reduced (all  P  < 0.05), whereas HSI and FIB-4 index were maintained (all  P  > 0.05).","['Treatment-naïve patients with CHB who were initiated on antiviral therapy (AVT) were enrolled', 'patients with CHB', 'The mean age of the study patients was 56 years with a male predominance (n = 178, 64.7', 'Patients with Chronic Hepatitis B']","['BSV with L-carnitine', 'Besifovir dipivoxil maleate (BSV) with L-carnitine', 'BSV combined with L-carnitine', 'Besifovir Dipivoxil Maleate Combined with L-Carnitine']","['HSI and FIB-4 index', 'hepatic steatosis index (HSI), and HS improvement', 'HSI score', 'mean HSI and fibrosis (FIB)-4 index', 'platelet count', 'fasting glucose', 'total cholesterol', 'Hepatic Steatosis', 'hepatic steatosis (HS', 'mean body mass index (BMI), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and platelet count', 'BMI, diabetes, cirrhosis, fasting glucose level, and ALT']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C4080032', 'cui_str': 'besifovir'}, {'cui': 'C0024572', 'cui_str': 'Maleates'}, {'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4304377', 'cui_str': 'Fibrosis-4 index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}]",,0.0250935,"In the BSV group, AST (mean, 95.2→30.2 IU/L) and ALT (mean, 81.1→31.1 IU/L) levels significantly reduced (all  P  < 0.05), whereas HSI and FIB-4 index were maintained (all  P  > 0.05).","[{'ForeName': 'Yeon Woo', 'Initials': 'YW', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Moonhyun', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Beom Kyung', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jun Yong', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Do Young', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sang Hoon', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kwang Hyub', 'Initials': 'KH', 'LastName': 'Han', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seung Up', 'Initials': 'SU', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}]",Journal of Korean medical science,['10.3346/jkms.2020.35.e104']
40,32358349,Observation for clinical effect of acupuncture combined with conventional therapy in the treatment of acne vulgaris.,"INTRODUCTION


Acne vulgaris is a chronic inflammatory disease of the sebaceous glands that occurs in adolescent men and women. In recent years, the incidence of acne has increased year by year, so it is of great significance to find a precise and effective treatment and further explore its possible mechanism of action. The purpose of this study will be to explore a treatment method that has both traditional Chinese medicine characteristics and significant effects, and provides a higher level of evidence for acupuncture for acne vulgaris. It also provides patients with more treatment options.
METHODS/DESIGN


The study will be a randomized controlled trial divided into 2 parallel groups. This pragmatic randomized controlled trial will recruit 66 patients who are diagnosed with acne vulgaris. 30-minutes acupuncture sessions will be provided to patients assigned to the intervention group. All participants will continue to receive conventional treatment. The selection of outcomes will be evaluated by the skin lesions score scale.
DISCUSSION


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


CTR2000030427.",2020,"This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of acupuncture for patients with acne vulgaris.
","['adolescent men and women', '66 patients who are diagnosed with acne vulgaris', 'patients with acne vulgaris', 'acne vulgaris']","['acupuncture combined with conventional therapy', 'acupuncture']",['skin lesions score scale'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0037284', 'cui_str': 'Skin lesion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",66.0,0.167358,"This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of acupuncture for patients with acne vulgaris.
","[{'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Kou', 'Affiliation': ""Department of Dermatology, The Third People's Hospital of Ningxia.""}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Yu', 'Affiliation': 'Department of Dermatology, General Hospital of Ningxia Medical University.'}, {'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': ""Department of Tumor surgery, The First People's Hospital of Yinchuan.""}, {'ForeName': 'Bingyan', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Dermatology, General Hospital of Ningxia Medical University.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Department of Dermatology, Huabei Petroleum General Hospital, China.'}]",Medicine,['10.1097/MD.0000000000019764']
41,32361689,PECS II may reduce chronic pain after breast surgery: A propensity score based secondary analysis of the BREAST trial.,,2020,,['after breast surgery'],['PECS'],['chronic pain'],"[{'cui': 'C0851312', 'cui_str': 'Breast surgery'}]","[{'cui': 'C0055065', 'cui_str': 'CEP combination'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}]",,0.250447,,"[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'De Cassai', 'Affiliation': 'UOC Anesthesia and Intensive Care Unit, University Hospital of Padova, Padova, Italy. Electronic address: alessandro.decassai@aopd.veneto.it.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Bonanno', 'Affiliation': 'Department of Medicine - DIMED, Section of Anesthesiology and Intensive Care, University of Padova, Padova, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Andreatta', 'Affiliation': 'Department of Medicine - DIMED, Section of Anesthesiology and Intensive Care, University of Padova, Padova, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Marchet', 'Affiliation': 'Day Surgery Multidisciplinare, Surgical Department, Azienda Ospedaliera Padova, Padova, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Barbieri', 'Affiliation': 'UOC Anesthesia and Intensive Care Unit, University Hospital of Padova, Padova, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Feltracco', 'Affiliation': 'UOC Anesthesia and Intensive Care Unit, University Hospital of Padova, Padova, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Carron', 'Affiliation': 'Department of Medicine - DIMED, Section of Anesthesiology and Intensive Care, University of Padova, Padova, Italy.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109851']
42,32361019,"Efficacy of green tea and its extract, epigallocatechin-3-gallate, in the reduction of cariogenic microbiota in children: a randomized clinical trial.","OBJECTIVE


This study was conducted to evaluate and compare the antimicrobial efficacy of green tea and its extract epigallocatechin-3-gallate (EGCG) as a mouthwash in children.
DESIGN


The study group included 47 children aged 5-12 years at high caries risk and prevalence. Children selected were asked to rinse with one of the substances (EGCG, green tea, chlorhexidine and distilled water) for one min. A non-stimulated salivary sample (2 mL) was collected at baseline and after rinsing. The concentration of cariogenic microorganisms (mutans streptococci and lactobacilli) was determined before and after rinsing based on the count of colony-forming units (CFU). CFU were counted with the aid of a stereomicroscope through the perfunctory identification of the morphological characteristics of CFU. The microbial reduction percentage was then calculated.
RESULTS


The analysis of the effectiveness of the treatments showed that there was a significant reduction in relation to the values obtained before and after the mouthwash, both for mutans streptococci (pCHX = 0.001; pEGCG = 0.001; pGreen Tea = 0.005; pDistilled Water = 0.018) and lactobacilli (pCHX = 0.001; pEGCG = 0.002; pGreen Tea = 0.008; pDistilled Water = 0.033). The percentage of microbial reduction of both cariogenic microorganisms caused by the EGCG solution was higher than green tea and distilled water, but less than CHX. The percentage of microbial reduction by the EGCG solution for mutans streptococci was 79.9%, green tea 68.3%, distilled water 50.6% and CHX 95.5%. For lactobacilli, the percentage reduction of all solutions was relatively lower when compared to mutans streptococci. For the EGCG solution it was 72.09%, followed by green tea 59.17% and distilled water 41.96%, but less than CHX 86.02%.
CONCLUSION


Rinsing with EGCG solution reduced the levels of mutans streptococci and lactobacilli in the oral cavity of children. Although EGCG had better antimicrobial activity than green tea, this study supports the effectiveness of both as an antibacterial mouthwash option. Both EGCG and green tea could be used as alternatives to chlorhexidine-based mouthwashes.",2020,Rinsing with EGCG solution reduced the levels of mutans streptococci and lactobacilli in the oral cavity of children.,"['47 children aged 5-12 years at high caries risk and prevalence', 'children']","['green tea and its extract, epigallocatechin-3-gallate', 'EGCG solution', 'EGCG', 'green tea and its extract epigallocatechin-3-gallate (EGCG', 'EGCG and green tea', 'substances (EGCG, green tea, chlorhexidine and distilled water']","['cariogenic microbiota', 'levels of mutans streptococci and lactobacilli', 'percentage of microbial reduction', 'concentration of cariogenic microorganisms (mutans streptococci and lactobacilli', 'antimicrobial activity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]","[{'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1271650', 'cui_str': 'Antimicrobial activity'}]",47.0,0.0581381,Rinsing with EGCG solution reduced the levels of mutans streptococci and lactobacilli in the oral cavity of children.,"[{'ForeName': 'Marina Moscardini', 'Initials': 'MM', 'LastName': 'Vilela', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirão Preto, SP, Brazil. Electronic address: marina.vilela@usp.br.'}, {'ForeName': 'Sérgio Luiz', 'Initials': 'SL', 'LastName': 'Salvador', 'Affiliation': 'Department of Clinical Analyses, Toxicology and Food Sciences, School of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Isabella Girardelli Lopes', 'Initials': 'IGL', 'LastName': 'Teixeira', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Marina Constante Gabriel', 'Initials': 'MCG', 'LastName': 'Del Arco', 'Affiliation': 'Department of Clinical Analyses, Toxicology and Food Sciences, School of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Andiara', 'Initials': 'A', 'LastName': 'De Rossi', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirão Preto, SP, Brazil.'}]",Archives of oral biology,['10.1016/j.archoralbio.2020.104727']
43,32357152,Effects of antenatal hypnosis on maternal salivary cortisol during childbirth and six weeks postpartum-A randomized controlled trial.,"BACKGROUND


Cortisol has been used to capture psychophysiological stress during childbirth and postpartum wellbeing. We explored the effect of a brief antenatal training course in self-hypnosis on salivary cortisol during childbirth and 6 weeks postpartum.
METHODS


In a randomized, controlled trial conducted at Aarhus University Hospital Skejby Denmark during the period January 2010 until October 2010, a total of 349 healthy nulliparous women were included. They were randomly allocated to a hypnosis group (n = 136) receiving three one-hour lessons in self-hypnosis with additional audio-recordings, a relaxation group (n = 134) receiving three one-hour lessons in various relaxation methods with audio-recordings for additional training, and a usual care group (n = 79) receiving ordinary antenatal care only. Salivary cortisol samples were collected during childbirth (at the beginning of the pushing state, 30 minutes, and 2 hours after childbirth), and 6 weeks postpartum (at wake up, 30 minutes after wake up, and evening). Cortisol concentrations were compared using a linear mixed-effects model. Correlations between cortisol concentrations and length of birth, experienced pain and calmness during birth were examined by a Spearman rank correlation test.
FINDINGS


During childbirth, week correlations were found between cortisol concentrations 30 minutes after childbirth and length of birth. In the beginning of the pushing state and 2 hours after childbirth, we found a tendency towards higher cortisol concentrations in the hypnosis group compared to the other two groups (hypnosis versus relaxation p = 0.02 and 0.03, hypnosis versus usual care p = 0.08 and 0.05). No differences were observed in cortisol concentrations between the groups 30 minutes after childbirth (hypnosis versus relaxation p = 0.08, hypnosis versus usual care 0.10) or 6 weeks postpartum (hypnosis versus relaxation: p = 0.85, 0.51, and 0.68, hypnosis versus usual care: p = 0.85, 0.93, and 0.96).
CONCLUSION


Antenatal hypnosis training may increase the release of cortisol during childbirth with no long-term consequences. Further research is needed to help interpret these findings.",2020,"No differences were observed in cortisol concentrations between the groups 30 minutes after childbirth (hypnosis versus relaxation p = 0.08, hypnosis versus usual care 0.10) or 6 weeks postpartum (hypnosis versus relaxation: p = 0.85, 0.51, and 0.68, hypnosis versus usual care: p = 0.85, 0.93, and 0.96).
","['at Aarhus University Hospital Skejby Denmark during the period January 2010 until October 2010, a total of 349 healthy nulliparous women were included']","['Antenatal hypnosis training', 'antenatal hypnosis', 'hypnosis group (n = 136) receiving three one-hour lessons in self-hypnosis with additional audio-recordings, a relaxation group (n = 134) receiving three one-hour lessons in various relaxation methods with audio-recordings for additional training, and a usual care group (n = 79) receiving ordinary antenatal care only']","['Salivary cortisol samples', 'cortisol concentrations and length of birth, experienced pain and calmness during birth', 'release of cortisol during childbirth', 'Cortisol concentrations', 'cortisol concentrations', 'maternal salivary cortisol']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",349.0,0.0956058,"No differences were observed in cortisol concentrations between the groups 30 minutes after childbirth (hypnosis versus relaxation p = 0.08, hypnosis versus usual care 0.10) or 6 weeks postpartum (hypnosis versus relaxation: p = 0.85, 0.51, and 0.68, hypnosis versus usual care: p = 0.85, 0.93, and 0.96).
","[{'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Werner', 'Affiliation': 'Institute of Clinical Research, Research Unit of Gynecology and Obstetrics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Chunsen', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Institute of Clinical Research, Research Unit of Gynecology and Obstetrics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zachariae', 'Affiliation': 'Department of Oncology, Unit for Psychooncology and Health Psychology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Ellen A', 'Initials': 'EA', 'LastName': 'Nohr', 'Affiliation': 'Institute of Clinical Research, Research Unit of Gynecology and Obstetrics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Uldbjerg', 'Affiliation': 'Department of Gynecology and Obstetrics, Aarhus University Hospital Skejby, Aarhus, Denmark.'}, {'ForeName': 'Åse Marie', 'Initials': 'ÅM', 'LastName': 'Hansen', 'Affiliation': 'Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}]",PloS one,['10.1371/journal.pone.0230704']
44,32375788,Reaching exercise for chronic paretic upper extremity after stroke using a novel rehabilitation robot with arm-weight support and concomitant electrical stimulation and vibration: before-and-after feasibility trial.,"BACKGROUND


Our group developed a rehabilitation robot to assist with repetitive, active reaching movement of a paretic upper extremity. The robot is equipped with a servo motor-controlled arm-weight support and works in conjunction with neuromuscular electrical stimulation and vibratory stimulation to facilitate agonist-muscle contraction. In this before-and-after pilot study, we assessed the feasibility of applying the robot to improve motor control and function of the hemiparetic upper extremity in patients who suffered chronic stroke.
METHODS


We enrolled 6 patients with chronic stroke and hemiparesis who, while sitting and without assistance, could reach 10 cm both sagitally and vertically (from a starting position located 10 cm forward from the patient's navel level) with the affected upper extremity. The patients were assigned to receive reaching exercise intervention with the robot (Yaskawa Electric Co., Ltd. Fukuoka, Japan) for 2 weeks at 15 min/day in addition to regular occupational therapy for 40 min/day. Outcomes assessed before and after 2 weeks of intervention included the upper extremity component of the Fugl-Meyer Assessment (UE-FMA), the Action Research Arm Test (ARAT), and, during reaching movement, kinematic analysis.
RESULTS


None of the patients experienced adverse events. The mean score of UE-FMA increased from 44.8 [SD 14.4] to 48.0 [SD 14.4] (p = 0.026, r = 0.91), and both the shoulder-elbow and wrist-hand scores increased after 2-week intervention. An increase was also observed in ARAT score, from mean 29.8 [SD 16.3] to 36.2 [SD 18.1] (p = 0.042, r = 0.83). Kinematic analysis during the reaching movement revealed a significant increase in active range of motion (AROM) at the elbow, and movement time tended to decrease. Furthermore, trajectory length for the wrist (""hand path"") and the acromion (""trunk compensatory movement"") showed a decreasing trend.
CONCLUSIONS


This robot-assisted modality is feasible and our preliminary findings suggest it improved motor control and motor function of the hemiparetic upper extremity in patients with chronic stroke. Training with this robot might induce greater AROM for the elbow and decrease compensatory trunk movement, thus contributing to movement efficacy and efficiency. Trial registration UMIN Clinical Trial Registry, as UMIN000018132, on June 30, 2015. https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000020398.",2020,This robot-assisted modality is feasible and our preliminary findings suggest it improved motor control and motor function of the hemiparetic upper extremity in patients with chronic stroke.,"[""6 patients with chronic stroke and hemiparesis who, while sitting and without assistance, could reach 10\xa0cm both sagitally and vertically (from a starting position located 10\xa0cm forward from the patient's navel level) with the affected upper extremity"", 'patients who suffered chronic stroke', 'patients with chronic stroke']","['reaching exercise intervention with the robot (Yaskawa Electric Co., Ltd', 'Reaching exercise', 'novel rehabilitation robot with arm-weight support and concomitant electrical stimulation and vibration']","['upper extremity component of the Fugl-Meyer Assessment (UE-FMA), the Action Research Arm Test (ARAT), and, during reaching movement, kinematic analysis', 'ARAT score', 'mean score of UE-FMA', 'adverse events', 'active range of motion (AROM', 'shoulder-elbow and wrist-hand scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}]","[{'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C1136140', 'cui_str': 'Long-Term Depression, Neurophysiologic'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]",6.0,0.0474659,This robot-assisted modality is feasible and our preliminary findings suggest it improved motor control and motor function of the hemiparetic upper extremity in patients with chronic stroke.,"[{'ForeName': 'Yumeko', 'Initials': 'Y', 'LastName': 'Amano', 'Affiliation': 'Department of Rehabilitation and Physical Medicine, Kagoshima University Graduate School of Medical and Dental Sciences, 8-35-1 Sakuragaoka, Kagoshima, 890-8520, Japan.'}, {'ForeName': 'Tomokazu', 'Initials': 'T', 'LastName': 'Noma', 'Affiliation': 'Kagoshima University Hospital Kirishima Rehabilitation Center, Kagoshima, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Etoh', 'Affiliation': 'Department of Rehabilitation and Physical Medicine, Kagoshima University Graduate School of Medical and Dental Sciences, 8-35-1 Sakuragaoka, Kagoshima, 890-8520, Japan.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Miyata', 'Affiliation': 'Department of Rehabilitation and Physical Medicine, Kagoshima University Graduate School of Medical and Dental Sciences, 8-35-1 Sakuragaoka, Kagoshima, 890-8520, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kawamura', 'Affiliation': 'Department of Rehabilitation and Physical Medicine, Kagoshima University Graduate School of Medical and Dental Sciences, 8-35-1 Sakuragaoka, Kagoshima, 890-8520, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Shimodozono', 'Affiliation': 'Department of Rehabilitation and Physical Medicine, Kagoshima University Graduate School of Medical and Dental Sciences, 8-35-1 Sakuragaoka, Kagoshima, 890-8520, Japan. rihakoza@m2.kufm.kagoshima-u.ac.jp.'}]",Biomedical engineering online,['10.1186/s12938-020-00774-3']
45,32362229,Effect of Intensive Blood Pressure Lowering on the Risk of Atrial Fibrillation.,"It remains uncertain whether intensive control of blood pressure (BP) results in a lower risk of atrial fibrillation (AF) in patients with hypertension. Using data from SPRINT (Systolic Blood Pressure Intervention Trial), which enrolled participants with hypertension at increased risk of cardiovascular disease, we examined whether intensive BP lowering (target systolic BP [SBP] <120 mm Hg), compared with standard BP lowering (target SBP<140 mm Hg), results in a lower risk of AF. This analysis included 8022 participants (4003 randomized to the intensive arm and 4019 to standard BP arm) who were free of AF at the time of enrollment and with available baseline and follow-up electrocardiographic data. AF was ascertained from standard 12-lead electrocardiograms recorded at biannual study examinations and an exit visit. During up to 5.2 years of follow-up and a total of 28 322 person-years, 206 incident AF cases occurred; 88 in the intensive BP-lowering arm and 118 in the standard BP-lowering arm. Intensive BP lowering was associated with a 26% lower risk of developing new AF (hazard ratio, 0.74 [95% CI, 0.56-0.98];  P =0.037). This effect was consistent among prespecified subgroups of SPRINT participants stratified by age, sex, race, SBP tertiles, prior cardiovascular disease, and prior chronic kidney disease when interactions between treatment effect and these subgroups were assessed using Hommel adjusted  P  values. In conclusion, intensive treatment to a target of SBP <120 mm Hg in patients with hypertension at high risk of cardiovascular disease has the potential to reduce the risk of AF. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT01206062.",2020,"Intensive BP lowering was associated with a 26% lower risk of developing new AF (hazard ratio, 0.74 [95% CI, 0.56-0.98];  P =0.037).","['enrolled participants with hypertension at increased risk of cardiovascular disease', 'patients with hypertension', '8022 participants (4003 randomized to the intensive arm and 4019 to standard BP arm) who were free of AF at the time of enrollment and with available baseline and follow-up electrocardiographic data', 'patients with hypertension at high risk of cardiovascular disease']","['Intensive Blood Pressure Lowering', 'SBP']","['intensive BP lowering (target systolic BP [SBP', 'Intensive BP lowering', 'Risk of Atrial Fibrillation', 'blood pressure (BP']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1277632', 'cui_str': 'Target systolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",,0.199646,"Intensive BP lowering was associated with a 26% lower risk of developing new AF (hazard ratio, 0.74 [95% CI, 0.56-0.98];  P =0.037).","[{'ForeName': 'Elsayed Z', 'Initials': 'EZ', 'LastName': 'Soliman', 'Affiliation': 'From the Epidemiological Cardiology Research Center, Department of Epidemiology and Prevention, Division of Public Health Sciences and Department of Medicine, Section on Cardiology, Wake Forest School of Medicine, Winston-Salem, NC (E.Z.S.).'}, {'ForeName': 'Akm F', 'Initials': 'AF', 'LastName': 'Rahman', 'Affiliation': 'Department of Biostatistics (A.F.R.), University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Zhu-Ming', 'Initials': 'ZM', 'LastName': 'Zhang', 'Affiliation': 'Epidemiological Cardiology Research Center (EPICARE), Department of Epidemiology and Prevention, Division of Public Health Sciences (Z-M.Z.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Carlos J', 'Initials': 'CJ', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Medicine/Cardiology, Albert Einstein College of Medicine, Bronx, NY (C.J.R.).'}, {'ForeName': 'Tara I', 'Initials': 'TI', 'LastName': 'Chang', 'Affiliation': 'Division of Nephrology, Stanford University School of Medicine, Palo Alto, CA (T.I.C.).'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Bates', 'Affiliation': 'Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, Houston, TX (J.T.B.).'}, {'ForeName': 'Lama', 'Initials': 'L', 'LastName': 'Ghazi', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN (L.G.).'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Blackshear', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic Florida, Jacksonville, FL (J.L.B.).'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, Aurora, CO (M.C.).'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Fine', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, MD (L.J.F.).'}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences (W.T.A.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Department of Epidemiology, and Department of Medicine (C.E.L.), University of Alabama at Birmingham, Birmingham, AL.'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.14766']
46,32362231,Incidence and Implications of Atrial Fibrillation/Flutter in Hypertension: Insights From the SPRINT Trial.,"We evaluated the impact of intensive blood pressure control on the incidence of new-onset atrial fibrillation/flutter (AF) and the prognostic implications of preexisting and new-onset AF in SPRINT (Systolic Blood Pressure Intervention Trial) participants. New-onset AF was defined as occurrence of AF in 12-lead electrocardiograms after randomization in participants free of AF at baseline. Poisson regression modeling was used to calculate incident rates of new-onset AF. Multivariable-adjusted Cox proportional hazard models were used to evaluate the risk of adverse cardiovascular events (composite of myocardial infarction, non-myocardial infarction acute coronary syndrome, stroke, heart failure, or cardiovascular death). In 9327 participants, 8.45% had preexisting AF, and 1.65% had new-onset AF. The incidence of new-onset AF was 4.53 per 1000-person years, with similar rates in the standard and intensive treatment arms (4.95 versus 4.11 per 1000-person years; adjusted  P =0.14). Participants with preexisting AF (adjusted hazard ratio, 1.83 [95% CI, 1.46-2.31];  P <0.001) and new-onset AF (adjusted hazard ratio, 2.45 [95% CI, 1.58-3.80];  P <0.001) had a greater risk for development of adverse cardiovascular events compared with those with no AF. Participants with preexisting AF who achieved blood pressure <120/80 mm Hg at 3 months continued have a poor prognosis (adjusted hazard ratio, 1.88 [95% CI, 1.32-2.70];  P =0.001) compared with those with no AF. Intensive blood pressure control does not diminish the incidence of new-onset AF in an older, high-risk, nondiabetic population. Both preexisting and new-onset AF have adverse prognostic implications. In participants with preexisting AF, residual cardiovascular risk is evident even with on-treatment blood pressure <120/80 mm Hg. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT01206062.",2020,"Participants with preexisting AF (adjusted hazard ratio, 1.83 [95% CI, 1.46-2.31];  P <0.001) and new-onset AF (adjusted hazard ratio, 2.45","['Hypertension', '9327 participants, 8.45% had preexisting AF, and 1.65% had new-onset AF']","['Intensive blood pressure control', 'intensive blood pressure control']","['incidence of new-onset AF', 'blood pressure', 'incidence of new-onset atrial fibrillation/flutter (AF', 'adverse cardiovascular events (composite of myocardial infarction, non-myocardial infarction acute coronary syndrome, stroke, heart failure, or cardiovascular death', 'adverse cardiovascular events']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0155709', 'cui_str': 'Atrial fibrillation and flutter'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0155709', 'cui_str': 'Atrial fibrillation and flutter'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",9327.0,0.274753,"Participants with preexisting AF (adjusted hazard ratio, 1.83 [95% CI, 1.46-2.31];  P <0.001) and new-onset AF (adjusted hazard ratio, 2.45","[{'ForeName': 'Vibhu', 'Initials': 'V', 'LastName': 'Parcha', 'Affiliation': 'From the Division of Cardiovascular Disease (V.P., J.K., G.A., P.A.), University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Nirav', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine (N.P.), University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Rajat', 'Initials': 'R', 'LastName': 'Kalra', 'Affiliation': 'Cardiovascular Division, University of Minnesota, Minneapolis (R.K.).'}, {'ForeName': 'Joonseok', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'From the Division of Cardiovascular Disease (V.P., J.K., G.A., P.A.), University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Orlando M', 'Initials': 'OM', 'LastName': 'Gutiérrez', 'Affiliation': 'Division of Nephrology, Department of Medicine (O.M.G.), University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Garima', 'Initials': 'G', 'LastName': 'Arora', 'Affiliation': 'From the Division of Cardiovascular Disease (V.P., J.K., G.A., P.A.), University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Arora', 'Affiliation': 'From the Division of Cardiovascular Disease (V.P., J.K., G.A., P.A.), University of Alabama at Birmingham, Birmingham.'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.14690']
47,32370774,Electronic pillbox-enabled self-administered therapy versus standard directly observed therapy for tuberculosis medication adherence and treatment outcomes in Ethiopia (SELFTB): protocol for a multicenter randomized controlled trial.,"BACKGROUND


To address the multifaceted challenges associated with tuberculosis (TB) in-person directly observed therapy (DOT), the World Health Organization recently recommended that countries maximize the use of digital adherence technologies. Sub-Saharan Africa needs to investigate the effectiveness of such technologies in local contexts and proactively contribute to global decisions around patient-centered TB care. This study aims to evaluate the effectiveness of pillbox-enabled self-administered therapy (SAT) compared to standard DOT on adherence to TB medication and treatment outcomes in Ethiopia. It also aims to assess the usability, acceptability, and cost-effectiveness of the intervention from the patient and provider perspectives.
METHODS


This is a multicenter, randomized, controlled, open-label, superiority, effectiveness-implementation hybrid, mixed-methods, two-arm trial. The study is designed to enroll 144 outpatients with new or previously treated, bacteriologically confirmed, drug-sensitive pulmonary TB who are eligible to start the standard 6-month first-line anti-TB regimen. Participants in the intervention arm (n = 72) will receive 15 days of HRZE-isoniazid, rifampicin, pyrazinamide, and ethambutol-fixed-dose combination therapy in the evriMED500 medication event reminder monitor device for self-administration. When returned, providers will count any remaining tablets in the device, download the pill-taking data, and refill based on preset criteria. Participants can consult the provider in cases of illness or adverse events outside of scheduled visits. Providers will handle participants in the control arm (n = 72) according to the standard in-person DOT. Both arms will be followed up throughout the 2-month intensive phase. The primary outcomes will be medication adherence and sputum conversion. Adherence to medication will be calculated as the proportion of patients who missed doses in the intervention (pill count) versus DOT (direct observation) arms, confirmed further by IsoScreen urine isoniazid test and a self-report of adherence on eight-item Morisky Medication Adherence Scale. Sputum conversion is defined as the proportion of patients with smear conversion following the intensive phase in intervention versus DOT arms, confirmed further by pre-post intensive phase BACTEC MGIT TB liquid culture. Pre-post treatment MGIT drug susceptibility testing will determine whether resistance to anti-TB drugs could have impacted culture conversion. Secondary outcomes will include other clinical outcomes (treatment not completed, death, or loss to follow-up), cost-effectiveness-individual and societal costs with quality-adjusted life years-and acceptability and usability of the intervention by patients and providers.
DISCUSSION


This study will be the first in Ethiopia, and of the first three in sub-Saharan Africa, to determine whether electronic pillbox-enabled SAT improves adherence to TB medication and treatment outcomes, all without affecting the inherent dignity and economic wellbeing of patients with TB.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04216420. Registered on 2 January 2020.",2020,This study aims to evaluate the effectiveness of pillbox-enabled self-administered therapy (SAT) compared to standard DOT on adherence to TB medication and treatment outcomes in Ethiopia.,"['patients with TB', '144 outpatients with new or previously treated, bacteriologically confirmed, drug-sensitive pulmonary TB who are eligible to start the standard 6-month first-line anti-TB regimen', 'Ethiopia', 'Ethiopia (SELFTB']","['Electronic pillbox-enabled self-administered therapy versus standard directly observed therapy', 'HRZE-isoniazid, rifampicin, pyrazinamide, and ethambutol-fixed-dose combination therapy in the evriMED500 medication event reminder monitor device for self-administration', 'pillbox-enabled self-administered therapy (SAT']","['clinical outcomes (treatment not completed, death, or loss to follow-up), cost-effectiveness-individual and societal costs with quality-adjusted life years-and acceptability and usability of the intervention by patients and providers', 'medication adherence and sputum conversion', 'usability, acceptability, and cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}, {'cui': 'C0014964', 'cui_str': 'Ethambutol'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0181904', 'cui_str': 'Monitor'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444661', 'cui_str': 'Stopped before completion'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C4759659', 'cui_str': 'With quality'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}]",144.0,0.142067,This study aims to evaluate the effectiveness of pillbox-enabled self-administered therapy (SAT) compared to standard DOT on adherence to TB medication and treatment outcomes in Ethiopia.,"[{'ForeName': 'Tsegahun', 'Initials': 'T', 'LastName': 'Manyazewal', 'Affiliation': 'Addis Ababa University, College of Health Sciences, Center for Innovative Drug Development and Therapeutic Trials for Africa, P.O. Box 9086, Addis Ababa, Ethiopia. tsegahunm@gmail.com.'}, {'ForeName': 'Yimtubezinash', 'Initials': 'Y', 'LastName': 'Woldeamanuel', 'Affiliation': 'Addis Ababa University, College of Health Sciences, Center for Innovative Drug Development and Therapeutic Trials for Africa, P.O. Box 9086, Addis Ababa, Ethiopia.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Holland', 'Affiliation': 'Emory University School of Medicine and Rollins School of Public Health, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Abebaw', 'Initials': 'A', 'LastName': 'Fekadu', 'Affiliation': 'Addis Ababa University, College of Health Sciences, Center for Innovative Drug Development and Therapeutic Trials for Africa, P.O. Box 9086, Addis Ababa, Ethiopia.'}, {'ForeName': 'Henry M', 'Initials': 'HM', 'LastName': 'Blumberg', 'Affiliation': 'Emory University School of Medicine and Rollins School of Public Health, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Marconi', 'Affiliation': 'Emory University School of Medicine and Rollins School of Public Health, Atlanta, GA, 30322, USA.'}]",Trials,['10.1186/s13063-020-04324-z']
48,32376984,"Different exercise training modalities produce similar endothelial function improvements in individuals with prehypertension or hypertension: a randomized clinical trial Exercise, endothelium and blood pressure.","Endothelial dysfunction is a characteristic of systemic arterial hypertension (SAH) and an early marker of atherosclerosis. Aerobic exercise training (AT) improves endothelial function. However, the effects of resistance training (RT) and combined training (CT) on endothelial function remain controversial in individuals with SAH. We determined the effects of AT, RT, and CT on endothelial function and systolic (SBP)/diastolic blood pressure (DBP) in individuals with prehypertension or hypertension. Forty-two participants (54 ± 11 y, resting SBP/DBP 137 ± 9/86 ± 6 mmHg) were randomly allocated into AT (n = 14, 40 min of cycling, 50-75% heart rate reserve), RT (n = 14, 6 resistance exercises, 4 × 12 repetitions, 60% maximum strength) and CT (n = 14, 2 × 12 repetitions of RT + 20 min of AT). All participants performed a 40-minute exercise session twice a week for 8 weeks. Endothelial function was evaluated by brachial artery flow-mediated dilation (FMD). Blood pressure was evaluated through ambulatory monitoring for 24 hours. After 8 weeks of exercise training, blood pressure was reduced in all 3 groups: -5.1 mmHg in SBP (95%CI -10.1, 0.0; p = 0.003) in AT; -4.0 mmHg in SBP (95%CI -7.8, -0.5; p = 0.027) in RT; and -3.2 mmHg in DBP (95%CI -7.9, 1.5; p = 0.001) in CT. All 3 exercise training modalities produced similar improvements in FMD: + 3.2% (95%CI 1.7, 4.6) (p < 0.001) in AT; + 4.0% (95%CI 2.1, 5.7) (p < 0.001) in RT; and +6.8% (95%CI 2.6, 11.1) (p = 0.006) in CT. In conclusion, different exercise training modalities were similarly effective in improving endothelial function but impacts on ambulatory blood pressure appear to be variable in individuals with prehypertension or hypertension.",2020,"After 8 weeks of exercise training, blood pressure was reduced in all 3 groups: -5.1 mmHg in SBP (95%CI -10.1, 0.0; p = 0.003) in AT; -4.0 mmHg in SBP (95%CI -7.8, -0.5; p = 0.027) in RT; and -3.2 mmHg in DBP (95%CI -7.9, 1.5; p = 0.001) in CT.","['Forty-two participants (54\u2009±\u200911\u2009y, resting SBP/DBP 137\u2009±\u20099/86\u2009±\u20096\u2009mmHg', 'individuals with SAH', 'individuals with prehypertension or hypertension']","['AT, RT, and CT', '40-minute exercise session', 'exercise training modalities', 'Aerobic exercise training (AT', 'resistance training (RT) and combined training (CT']","['endothelial function', 'Endothelial function', 'blood pressure', 'endothelial function and systolic (SBP)/diastolic blood pressure (DBP', 'ambulatory blood pressure', 'brachial artery flow-mediated dilation (FMD', 'FMD', 'Blood pressure', 'endothelial function improvements']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1696708', 'cui_str': 'Prehypertension'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}]",,0.0337369,"After 8 weeks of exercise training, blood pressure was reduced in all 3 groups: -5.1 mmHg in SBP (95%CI -10.1, 0.0; p = 0.003) in AT; -4.0 mmHg in SBP (95%CI -7.8, -0.5; p = 0.027) in RT; and -3.2 mmHg in DBP (95%CI -7.9, 1.5; p = 0.001) in CT.","[{'ForeName': 'Marinei L', 'Initials': 'ML', 'LastName': 'Pedralli', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Marschner', 'Affiliation': 'Thyroid Section, Endocrine Division, Hospital de Clínicas de Porto Alegre, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Kollet', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Salvador G', 'Initials': 'SG', 'LastName': 'Neto', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Eibel', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Cardiovascular Aging Research Laboratory, Department of Kinesiology & Health Education, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Alexandre M', 'Initials': 'AM', 'LastName': 'Lehnen', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil. amlehnen@gmail.com.'}]",Scientific reports,['10.1038/s41598-020-64365-x']
49,32374724,The impact of an integrated depression and HIV treatment program on mental health and HIV care outcomes among people newly initiating antiretroviral therapy in Malawi.,"BACKGROUND


Depression is highly prevalent among patients newly starting antiretroviral treatment (ART) in Malawi and many other countries. Untreated depression at ART initiation can disrupt the HIV care continuum. Effective approaches for depression screening and treatment exist for low-resource settings, but they are rarely applied. Identifying effective implementation strategies are critical.
METHODS


A pilot program integrated depression screening and treatment into routine HIV care using existing staff at two public health clinics in Malawi in two phases; a screening-only ""control"" phase and an active ""intervention"" phase. During the intervention phase, providers prescribed antidepressants or referred patients for Friendship Bench problem-solving therapy. We evaluated the program's impact on retention in HIV care, viral suppression, and depression remission at 6 months using tabular comparisons and log-binomial models to estimate adjusted risk ratios and mean differences among the intervention group relative to the control group.
RESULTS


Nearly all consenting participants were screened for depression appropriately and 25% had mild to severe depressive symptoms. During the intervention phase, 86% of participants with mild depressive symptoms started Friendship Bench therapy and 96% of participants with moderate to severe depressive symptoms started antidepressants. Few participants in the intervention group received consistent depression treatment over their first 6 months in care. In the adjusted main analysis, program exposure did not demonstrably affect most HIV or mental health outcomes, though the probability of currently being on ART at 6 months was significantly lower among the intervention group than the control group [RR 0.6(95%CI: 0.4-0.9)].
CONCLUSIONS


While it is feasible to integrate depression screening and treatment initiation into ART initiation, providing ongoing depression treatment over time is challenging. Similar implementation science studies focused on maintaining depression management will be increasingly important as we strive to understand and test the best ways to implement evidence-based depression treatment within HIV care.",2020,"In the adjusted main analysis, program exposure did not demonstrably affect most HIV or mental health outcomes, though the probability of currently being on ART at 6 months was significantly lower among the intervention group than the control group [RR 0.6(95%CI: 0.4-0.9)].
","['A pilot program integrated depression screening and treatment into routine HIV care using existing staff at two public health clinics in Malawi in two phases; a', 'Nearly all consenting participants were screened for depression appropriately and 25% had mild to severe depressive symptoms', 'patients newly starting antiretroviral treatment (ART) in Malawi and many other countries', 'people newly initiating antiretroviral therapy in Malawi', 'participants with mild depressive symptoms started Friendship Bench therapy and 96% of participants with moderate to severe depressive symptoms started antidepressants']","['Friendship Bench problem-solving therapy', 'consistent depression treatment', 'screening-only ""control"" phase and an active ""intervention"" phase', 'integrated depression and HIV treatment program']","['mental health and HIV care outcomes', 'HIV or mental health outcomes', 'retention in HIV care, viral suppression, and depression remission']","[{'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0740218', 'cui_str': 'Depression screening'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}]","[{'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",,0.0805605,"In the adjusted main analysis, program exposure did not demonstrably affect most HIV or mental health outcomes, though the probability of currently being on ART at 6 months was significantly lower among the intervention group than the control group [RR 0.6(95%CI: 0.4-0.9)].
","[{'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Stockton', 'Affiliation': 'Epidemiology Department, University of North Carolina at Chapel Hill Gillings School of Global Public Health, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Udedi', 'Affiliation': 'NCDs & Mental Health Unit, Ministry of Health, Lilongwe, Malawi.'}, {'ForeName': 'Kazione', 'Initials': 'K', 'LastName': 'Kulisewa', 'Affiliation': 'Department of Mental Health, University of Malawi, College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'University of North Carolina Project-Malawi, Tidziwe Centre, Lilongwe, Malawi.'}, {'ForeName': 'Bradley N', 'Initials': 'BN', 'LastName': 'Gaynes', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Mphonda', 'Affiliation': 'University of North Carolina Project-Malawi, Tidziwe Centre, Lilongwe, Malawi.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Maselko', 'Affiliation': 'Epidemiology Department, University of North Carolina at Chapel Hill Gillings School of Global Public Health, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Audrey E', 'Initials': 'AE', 'LastName': 'Pettifor', 'Affiliation': 'Epidemiology Department, University of North Carolina at Chapel Hill Gillings School of Global Public Health, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Verhey', 'Affiliation': 'Friendship Bench Zimbabwe, Milton Park, Harare, Zimbabwe.'}, {'ForeName': 'Dixon', 'Initials': 'D', 'LastName': 'Chibanda', 'Affiliation': 'Friendship Bench Zimbabwe, Milton Park, Harare, Zimbabwe.'}, {'ForeName': 'Ilana', 'Initials': 'I', 'LastName': 'Lapidos-Salaiz', 'Affiliation': 'United States Agency for International Development (USAID), Arlington, VA, United States of America.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Pence', 'Affiliation': 'Epidemiology Department, University of North Carolina at Chapel Hill Gillings School of Global Public Health, Chapel Hill, NC, United States of America.'}]",PloS one,['10.1371/journal.pone.0231872']
50,32364879,Pro-Con Perspectives on Ethics in Surgical Research: Update from the 39th Annual Surgical Infection Society Meeting.,"Background:  Surgical research is potentially invasive, high-risk, and costly. Research that advances medical dogma must justify both its ends and its means. Although ethical questions do not always have simple answers, it is critically important for the clinician, researcher, and patient to approach these dilemmas and surgical research in a thoughtful, conscientious manner.  Methods:  We present four ethical issues in surgical research and discuss the opposing viewpoints. These topics were presented and discussed at the 39th Annual Meeting of the Surgical Infection Society as pro-con debates. The presenters of each opinion developed a succinct summary of their respective reviews for this publication.  Results:  The key subjects for these pro-con debates were: (1) Should patients be enrolled for time-sensitive surgical infection research using an opt-out or an opt-in strategy? (2) Should patients who are being enrolled in a randomized controlled trial (RCT) comparing surgery with a non-operative intervention pay the costs of their treatment arm? (3) Should the scientific community embrace open access journals as the future of scientific publishing? (4) Should the majority of funding go to clinical or basic science research? Important points were illustrated in each of the pro-con presentations and illustrated the difficulties that are facing the performance and payment of infection research in the future.  Conclusions:  Surgical research is ethically complex, with conflicting demands between individual patients, society, and healthcare economics. At present, there are no clear answers to these and the many other ethical issues facing research in the future. Answers will only come from continued robust dialogue among all stakeholders in surgical research.",2020,Important points were illustrated in each of the pro-con presentations and illustrated the difficulties that are facing the performance and payment of infection research in the future.  ,['Surgical Research'],[],[],"[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]",[],[],4.0,0.0241724,Important points were illustrated in each of the pro-con presentations and illustrated the difficulties that are facing the performance and payment of infection research in the future.  ,"[{'ForeName': 'Vanessa P', 'Initials': 'VP', 'LastName': 'Ho', 'Affiliation': 'Department of Surgery, MetroHealth Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Evelyn I', 'Initials': 'EI', 'LastName': 'Truong', 'Affiliation': 'Department of Surgery, MetroHealth Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Saira', 'Initials': 'S', 'LastName': 'Nisar', 'Affiliation': 'The Burn Center, Medstar Washington Hospital Center, Department of Surgery, Georgetown University School of Medicine, Washington, DC, USA.'}, {'ForeName': 'Addison K', 'Initials': 'AK', 'LastName': 'May', 'Affiliation': 'Department of Surgery, Carolinas Medical Center, Atrium Health, Charlotte, North Carolina, USA.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Beilman', 'Affiliation': 'Department of Surgery, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Donald E', 'Initials': 'DE', 'LastName': 'Fry', 'Affiliation': 'Department of Surgery, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Barie', 'Affiliation': 'Departments of Surgery and Public Health, Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Huston', 'Affiliation': 'Departments of Surgery and Science Education, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA.'}, {'ForeName': 'Jeffrey W', 'Initials': 'JW', 'LastName': 'Shupp', 'Affiliation': 'The Burn Center, Medstar Washington Hospital Center, Department of Surgery, Georgetown University School of Medicine, Washington, DC, USA.'}, {'ForeName': 'Fredric M', 'Initials': 'FM', 'LastName': 'Pieracci', 'Affiliation': 'Department of Surgery, Denver Health Medical Center/University of Colorado School of Medicine, Denver, Colorado, USA.'}]",Surgical infections,['10.1089/sur.2020.098']
51,32366156,"Triple fixed-dose combination empagliflozin, linagliptin, and metformin for patients with type 2 diabetes.","Objectives : Fixed-dose combination (FDC) therapy can improve outcomes in type 2 diabetes (T2D). We evaluated the bioequivalence of 2 doses of an FDC of extended-release metformin (metformin XR), empagliflozin, a sodium-glucose co-transporter 2 inhibitor, and linagliptin, a dipeptidyl peptidase-4 inhibitor, versus corresponding free tablet combinations. Methods : Two randomized, open-label, two-way crossover studies in healthy adults compared: 2 FDC tablets of empagliflozin 5 mg/linagliptin 2.5 mg/metformin XR 1000 mg (Study 1; N = 30), 1 FDC tablet of empagliflozin 25 mg/linagliptin 5 mg/metformin XR 1000 mg (Study 2; N = 30) versus corresponding dose of free combinations. Subjects received study medication under fed conditions; washout was ≥35 days between treatments. Primary endpoints: area under the plasma concentration-time curve (AUC) from time 0 to last quantifiable data point for empagliflozin and metformin; AUC from time 0 to 72 hours for linagliptin, and peak plasma concentration (C max ) for empagliflozin, linagliptin, and metformin. Bioequivalence was defined as adjusted geometric mean ratios (FDC: free combination) and two-sided 90% confidence intervals (CIs) of AUC and C max  for each component within 80.00-125.00%. Results : Study 1: 27/29 and 28/30 treated participants were included in the pharmacokinetic analysis for the FDC and free combination periods, respectively. Study 2: 29/29 treated participants were included in the pharmacokinetic analysis for both periods. The adjusted geometric mean ratios of FDCs to their respective free tablet combinations and two-sided 90% CIs were all within the predefined range. The shapes of the mean plasma concentration-time profile of empagliflozin, linagliptin, and metformin XR were similar for subjects in the FDC and free combination groups in both studies. No serious adverse events were reported. Conclusion : The evaluated doses of empagliflozin/linagliptin/metformin XR FDC tablets were bioequivalent to the corresponding free combinations. Based on these two bioequivalence studies and existing phase 3 data, the FDA has recently approved this triple FDC to improve glycemic control in adults with T2D.",2020,The evaluated doses of empagliflozin/linagliptin/metformin XR FDC tablets were bioequivalent to the corresponding free combinations.,"['healthy adults compared: 2', 'adults with T2D', 'Study 1: 27/29 and 28/30 treated participants were included in the pharmacokinetic analysis for the FDC and free combination periods, respectively', 'patients with type 2 diabetes']","['empagliflozin/linagliptin/metformin XR FDC tablets', 'empagliflozin, linagliptin, and metformin', 'Triple fixed-dose combination empagliflozin, linagliptin, and metformin', 'FDC of extended-release metformin (metformin XR), empagliflozin, a sodium-glucose co-transporter 2 inhibitor, and linagliptin, a dipeptidyl peptidase-4 inhibitor', 'FDC tablets of empagliflozin 5 mg/linagliptin 2.5 mg/metformin XR', 'FDC) therapy', 'FDC tablet of empagliflozin 25 mg/linagliptin 5 mg/metformin XR']","['area under the plasma concentration-time curve (AUC) from time 0 to last quantifiable data point for empagliflozin and metformin; AUC from time 0 to 72\xa0hours for linagliptin, and peak plasma concentration (C max ', 'adjusted geometric mean ratios of FDCs', 'mean plasma concentration-time profile of empagliflozin, linagliptin, and metformin XR', 'serious adverse events']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3871442', 'cui_str': 'linagliptin and empagliflozin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C4050744', 'cui_str': 'empagliflozin 5 MG'}, {'cui': 'C3265893', 'cui_str': 'Linagliptin 2.5 MG'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3883488', 'cui_str': 'empagliflozin 25 MG / Linagliptin 5 MG [Glyxambi]'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0607173,The evaluated doses of empagliflozin/linagliptin/metformin XR FDC tablets were bioequivalent to the corresponding free combinations.,"[{'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'Department of Internal Medicine/Endocrinology and Department of Population and Data Sciences, UT Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Beetz', 'Affiliation': 'Global Clinical Operations, Early Trials, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Sennewald', 'Affiliation': 'Global Clinical Operations, Early Trials, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Schuler-Metz', 'Affiliation': 'Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Bertulis', 'Affiliation': 'Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Loley', 'Affiliation': 'Biostatistics and Data Sciences, Clinical Statistics, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lang', 'Affiliation': 'Biostatistics and Data Sciences, Clinical Statistics, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Lippert', 'Affiliation': 'Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany.'}, {'ForeName': 'Jisoo', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Clinical Development & Cardiometabolism and Respiratory Medicine, Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Linda Shapiro', 'Initials': 'LS', 'LastName': 'Manning', 'Affiliation': 'Clinical Development & Medical Affairs - Cardiometabolism, Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT, USA.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Terada', 'Affiliation': 'Clinical Development & Medical Affairs - Cardiometabolism, Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT, USA.'}]",Postgraduate medicine,['10.1080/00325481.2020.1750228']
52,32088268,Chronic urticaria in children can be controlled effectively with updosing second-generation antihistamines.,,2020,,[],[],['Chronic urticaria'],[],[],"[{'cui': 'C0263338', 'cui_str': 'Chronic urticaria'}]",,0.0142078,,"[{'ForeName': 'Sofianne', 'Initials': 'S', 'LastName': 'Gabrielli', 'Affiliation': ""Division of Allergy, Immunology and Dermatology, Montreal Children's Hospital, Montreal, Quebec, Canada. Electronic address: sofiannegabrielli@gmail.com.""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Le', 'Affiliation': 'Faculty of Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Netchiporouk', 'Affiliation': 'Division of Dermatology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Miedzybrodzki', 'Affiliation': 'Division of Dermatology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Baum', 'Affiliation': 'Department of Dermatology, Sheba Medical Center, Ramat-Gan, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Shoshana', 'Initials': 'S', 'LastName': 'Greenberger', 'Affiliation': 'Department of Dermatology, Sheba Medical Center, Ramat-Gan, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Staubach-Renz', 'Affiliation': 'Department of Dermatology and Allergy, University Medical Center, Mainz, Germany.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Ben-Shoshan', 'Affiliation': ""Division of Allergy, Immunology and Dermatology, Montreal Children's Hospital, Montreal, Quebec, Canada.""}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.02.041']
53,32371520,"Study protocol for a randomised controlled trial evaluating an evidence-based, stepped and coordinated care service model for mental disorders (RECOVER).","INTRODUCTION


Healthcare systems around the world are looking for solutions to the growing problem of mental disorders. RECOVER is the synonym for an evidence-based, stepped and cross-sectoral coordinated care service model for mental disorders. RECOVER implements a cross-sectoral network with managed care, comprehensive psychological, somatic and social diagnostics, crisis resolution and a general structure of four severity levels, each with assigned evidence-based therapy models (eg, assertive community treatment) and therapies (eg, psychotherapy). The study rationale is the investigation of the effectiveness and efficiency of stepped and integrated care in comparison to standard care.
METHODS AND ANALYSIS


The trial is conducted in accordance to the Standard Protocol Items: Recommendations for Interventional Trials Statement. The study aims to compare the RECOVER model with treatment as usual (TAU). The following questions are examined: Does RECOVER reduce healthcare costs compared with TAU? Does RECOVER improve patient-relevant outcomes? Is RECOVER cost-effective compared with TAU? A total sample of 890 patients with mental disorders will be assessed at baseline and individually randomised into RECOVER or TAU. Follow-up assessments are conducted after 6 and 12 months. As primary outcomes, cost reduction, improvement in symptoms, daily functioning and quality of life as well as cost-effectiveness ratios will be measured. In addition, several secondary outcomes will be assessed. Primary and secondary outcomes are evaluated according to the intention-to-treat principle. Mixed linear or logistic regression models are used with the direct maximum likelihood estimation procedure which results in unbiassed estimators under the missing-at-random assumption. Costs due to healthcare utilisation and productivity losses are evaluated using difference-in-difference regressions.
ETHICS AND DISSEMINATION


Ethical approval from the ethics committee of the Hamburg Medical Association has been obtained (PV5672). The results will be disseminated to service users and their families via the media, to healthcare professionals via professional training and meetings and to researchers via conferences and publications.
TRIAL REGISTRATION NUMBER AND REGISTRY NAME


ClinicalTrials.gov (NCT03459664), RECOVER PROTOCOL VERSION: 19 March 2020 (V.3.0).",2020,"As primary outcomes, cost reduction, improvement in symptoms, daily functioning and quality of life as well as cost-effectiveness ratios will be measured.",['890 patients with mental disorders'],[],"['healthcare costs', 'intention-to-treat principle', 'cost reduction, improvement in symptoms, daily functioning and quality of life as well as cost-effectiveness ratios']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]",[],"[{'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",890.0,0.192617,"As primary outcomes, cost reduction, improvement in symptoms, daily functioning and quality of life as well as cost-effectiveness ratios will be measured.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lambert', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany lambert@uke.de.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Karow', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Gallinat', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lüdecke', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Kraft', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Rohenkohl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Romy', 'Initials': 'R', 'LastName': 'Schröter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Constanze', 'Initials': 'C', 'LastName': 'Finter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Anna-Katharina', 'Initials': 'AK', 'LastName': 'Siem', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tlach', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Werkle', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Bargel', 'Affiliation': 'Department of Strategic Business Development, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Gunda', 'Initials': 'G', 'LastName': 'Ohm', 'Affiliation': 'Department of Strategic Business Development, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hoff', 'Affiliation': 'Department of Strategic Business Development, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Peter', 'Affiliation': 'Ambulatory Healthcare Center for Psychotherapy, Psychiatry and Psychosomatic, Cognitive-Behavioral Therapy Falkenried MVZ GmbH, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Scherer', 'Affiliation': 'Department of General Practice/Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Mews', 'Affiliation': 'Department of General Practice/Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Pruskil', 'Affiliation': 'Department of General Practice/Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Lüke', 'Affiliation': 'Department of General Practice/Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Dirmaier', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schulte-Markwort', 'Affiliation': 'Department of Child- and Youth Psychiatry, Psychotherapy and Psychosomatics, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Löwe', 'Affiliation': 'Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Peer', 'Initials': 'P', 'LastName': 'Briken', 'Affiliation': 'Institute for Sex Research, Sexual Medicine and Forensic Psychiatry, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Peper', 'Affiliation': 'Chamber for Psychotherapists Hamburg, Hamburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schweiger', 'Affiliation': 'Service Provider for vocational rehabilitation, ARINET GmbH, Hamburg, Hamburg, Germany.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Mösko', 'Affiliation': 'Department of Medical Psychology, Research Group on Migration and Psychosocial Health, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bock', 'Affiliation': 'Irre Menschlich Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wittzack', 'Affiliation': 'Regional Psychiatric Patient Association Hamburg e.V, Hamburg, Germany.'}, {'ForeName': 'Hans-Jochim', 'Initials': 'HJ', 'LastName': 'Meyer', 'Affiliation': 'Regional Psychiatric Relative Association Hamburg e.V, Hamburg, Germany.'}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'Deister', 'Affiliation': 'Center for Psychosocial Medicine, Klinikum Itzehoe, Itzehoe, Schleswig-Holstein, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Michels', 'Affiliation': 'Center for Psychosocial Medicine, Klinikum Itzehoe, Itzehoe, Schleswig-Holstein, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Herr', 'Affiliation': 'Center for Psychosocial Medicine, Klinikum Itzehoe, Itzehoe, Schleswig-Holstein, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Konnopka', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'König', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Wegscheider', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Daubmann', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Zapf', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Peth', 'Affiliation': 'Department of Medical Psychology, Professorship Clinical Healthcare Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Schulz', 'Affiliation': 'Department of Medical Psychology, Professorship Clinical Healthcare Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-036021']
54,32379269,Olanzapine for the Treatment of Advanced Cancer-Related Chronic Nausea and/or Vomiting: A Randomized Pilot Trial.,"Importance


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


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


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


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


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


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


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


ClinicalTrials.gov Identifier: NCT03137121.",2020,"Correspondingly, patients in the olanzapine arm reported less emesis, less use of other antiemetic drugs, better appetite, less sedation, less fatigue, and better well-being.","['30 patients (15 per arm) were enrolled; these included 16 women and 14 men who had a mean (range) age of 63 (39-79) years', 'Eligible participants were outpatients with advanced cancer who had persistent nausea/vomiting without having had chemotherapy or radiotherapy in the prior 14 days', 'patients with advanced cancer', 'July 2017 through April 2019, with analysis conducted in 2019', 'Advanced Cancer-Related Chronic Nausea and/or Vomiting']","['olanzapine', 'Olanzapine', 'placebo']","['nausea and emesis', 'median nausea scores', 'Chronic nausea', 'excess sedation', 'Baseline median nausea scores', 'chronic nausea/vomiting', 'nausea scores', 'Nausea and vomiting', 'nausea numeric rating scores', 'emesis, less use of other antiemetic drugs, better appetite, less sedation, less fatigue, and better well-being']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C3654042', 'cui_str': 'Other antiemetics'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",30.0,0.258888,"Correspondingly, patients in the olanzapine arm reported less emesis, less use of other antiemetic drugs, better appetite, less sedation, less fatigue, and better well-being.","[{'ForeName': 'Rudolph M', 'Initials': 'RM', 'LastName': 'Navari', 'Affiliation': 'Comprehensive Cancer Center, University of Alabama at Birmingham.'}, {'ForeName': 'Cameron M', 'Initials': 'CM', 'LastName': 'Pywell', 'Affiliation': 'Comprehensive Cancer Center, University of Alabama at Birmingham.'}, {'ForeName': 'Jennifer G', 'Initials': 'JG', 'LastName': 'Le-Rademacher', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'White', 'Affiliation': 'Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Dodge', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Costantine', 'Initials': 'C', 'LastName': 'Albany', 'Affiliation': 'Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Loprinzi', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}]",JAMA oncology,['10.1001/jamaoncol.2020.1052']
55,32379280,Effect of Combined Immune Checkpoint Inhibition vs Best Supportive Care Alone in Patients With Advanced Colorectal Cancer: The Canadian Cancer Trials Group CO.26 Study.,"Importance


Single-agent immune checkpoint inhibition has not shown activities in advanced refractory colorectal cancer (CRC), other than in those patients who are microsatellite-instability high (MSI-H).
Objective


To evaluate whether combining programmed death-ligand 1 (PD-L1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibition improved patient survival in metastatic refractory CRC.
Design, Setting, and Participants


A randomized phase 2 study was conducted in 27 cancer centers across Canada between August 2016 and June 2017, and data were analyzed on October 18, 2018. Eligible patients had histologically confirmed adenocarcinoma of the colon or rectum; received all available standard systemic therapies (fluoropyrimidines, oxaliplatin, irinotecan, and bevacizumab if appropriate; cetuximab or panitumumab if RAS wild-type tumors; regorafenib if available); were aged 18 years or older; had adequate organ function; had Eastern Cooperative Oncology Group performance status of 0 or 1, and measurable disease.
Interventions


We randomly assigned patients to receive either 75 mg of tremelimumab every 28 days for the first 4 cycles plus 1500 mg durvalumab every 28 days, or best supportive care alone (BSC) in a 2:1 ratio.
Main Outcomes and Measures


The primary end point was overall survival (OS) and a 2-sided P<.10 was considered statistically significant. Circulating cell-free DNA from baseline plasma was used to determine microsatellite instability (MSI) and tumor mutation burden (TMB).
Results


Of 180 patients enrolled (121 men [67.2%] and 59 women [32.8%]; median [range] age, 65 [36-87] years), 179 were treated. With a median follow-up of 15.2 months, the median OS was 6.6 months for durvalumab and tremelimumab and 4.1 months for BSC (hazard ratio [HR], 0.72; 90% CI, 0.54-0.97; P = .07). Progression-free survival was 1.8 months and 1.9 months respectively (HR, 1.01; 90% CI, 0.76-1.34). Grade 3 or 4 adverse events were significantly more frequent with immunotherapy (75 [64%] patients in the treatment group had at least 1 grade 3 or higher adverse event vs 12 [20%] in the BSC group). Circulating cell-free DNA analysis was successful in 168 of 169 patients with available samples. In patients who were microsatellite stable (MSS), OS was significantly improved with durvalumab and tremelimumab (HR, 0.66; 90% CI, 0.49-0.89; P = .02). Patients who were MSS with plasma TMB of 28 variants per megabase or more (21% of MSS patients) had the greatest OS benefit (HR, 0.34; 90% CI, 0.18-0.63; P = .004).
Conclusions and Relevance


This phase 2 study suggests that combined immune checkpoint inhibition with durvalumab plus tremelimumab may be associated with prolonged OS in patients with advanced refractory CRC. Elevated plasma TMB may select patients most likely to benefit from durvalumab and tremelimumab. Further confirmation studies are warranted.
Trial Registration


ClinicalTrials.gov Identifier: NCT02870920.",2020,Grade 3 or 4 adverse events were significantly more frequent with immunotherapy (75 [64%] patients in the treatment group had at least 1 grade 3 or higher adverse event vs 12 [20%] in the BSC group).,"['if RAS wild-type tumors; regorafenib if available); were aged 18 years or older; had adequate organ function; had Eastern Cooperative Oncology Group performance status of 0 or 1, and measurable disease', 'Eligible patients had histologically confirmed adenocarcinoma of the colon or rectum', 'advanced refractory colorectal cancer (CRC', 'Patients With Advanced Colorectal Cancer', 'patients with advanced refractory CRC', '180 patients enrolled (121 men [67.2%] and 59 women [32.8%]; median [range] age, 65 [36-87] years), 179 were treated', '27 cancer centers across Canada between August 2016 and June 2017, and data were analyzed on October 18, 2018', '168 of 169 patients with available samples']","['standard systemic therapies (fluoropyrimidines, oxaliplatin, irinotecan, and bevacizumab if appropriate; cetuximab or panitumumab', 'Combined Immune Checkpoint Inhibition vs Best Supportive Care Alone', 'tremelimumab every 28 days for the first 4 cycles plus 1500 mg durvalumab every 28 days, or best supportive care alone (BSC']","['plasma TMB', 'median OS', 'Grade 3 or 4 adverse events', 'microsatellite instability (MSI) and tumor mutation burden (TMB', 'greatest OS benefit', 'overall survival (OS', 'Progression-free survival']","[{'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0338106', 'cui_str': 'Adenocarcinoma of colon'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C3873157', 'cui_str': 'Every twenty eight days'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0796369', 'cui_str': 'Microsatellite instability'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",180.0,0.228314,Grade 3 or 4 adverse events were significantly more frequent with immunotherapy (75 [64%] patients in the treatment group had at least 1 grade 3 or higher adverse event vs 12 [20%] in the BSC group).,"[{'ForeName': 'Eric X', 'Initials': 'EX', 'LastName': 'Chen', 'Affiliation': 'Princess Margaret Cancer Center, Toronto, Canada.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Jonker', 'Affiliation': 'The Ottawa Hospital, Ottawa, Canada.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Loree', 'Affiliation': 'BC Cancer, Vancouver, Canada.'}, {'ForeName': 'Hagen F', 'Initials': 'HF', 'LastName': 'Kennecke', 'Affiliation': 'Virginia Mason Medical Center, Seattle.'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Berry', 'Affiliation': ""Department of Oncology, Queen's University, Kingston, Canada.""}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Couture', 'Affiliation': 'CHU de Québec-Université, Laval, Canada.'}, {'ForeName': 'Chaudhary E', 'Initials': 'CE', 'LastName': 'Ahmad', 'Affiliation': ""Eastern Health, St John's, Canada.""}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Goffin', 'Affiliation': 'Juvravinski Cancer Center, Hamilton, Canada.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Kavan', 'Affiliation': 'Segal Cancer Center, Montreal, Canada.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Harb', 'Affiliation': 'Moncton Hospital, Moncton, Canada.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Colwell', 'Affiliation': 'Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Setareh', 'Initials': 'S', 'LastName': 'Samimi', 'Affiliation': 'Hôpital Sacré-Coeur de Montréal, Montreal, Canada.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Samson', 'Affiliation': 'Sherbrooke University, Sherbrooke, Canada.'}, {'ForeName': 'Tahir', 'Initials': 'T', 'LastName': 'Abbas', 'Affiliation': 'Saskatoon Cancer Center, Saskatoon, Canada.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Aucoin', 'Affiliation': 'Hôpital Cité-de-la-Santé, Laval, Canada.'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Aubin', 'Affiliation': ""Centre de recherche du Centre hospitalier de l'Université de Montréal (CHUM), Montreal, Canada.""}, {'ForeName': 'Sheryl L', 'Initials': 'SL', 'LastName': 'Koski', 'Affiliation': 'Cross Cancer Center, Edmonton, Canada.'}, {'ForeName': 'Alice C', 'Initials': 'AC', 'LastName': 'Wei', 'Affiliation': 'Princess Margaret Cancer Center, Toronto, Canada.'}, {'ForeName': 'Nadine M', 'Initials': 'NM', 'LastName': 'Magoski', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Canada.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Tu', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Canada.'}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': ""O'Callaghan"", 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Canada.'}]",JAMA oncology,['10.1001/jamaoncol.2020.0910']
56,32379288,Facedown Positioning Following Surgery for Large Full-Thickness Macular Hole: A Multicenter Randomized Clinical Trial.,"Importance


The value of facedown positioning following surgery for large full-thickness macular holes is unknown.
Objective


To determine whether advice to position facedown postoperatively improves the outcome for large macular holes.
Design, Setting, and Participants


This randomized, parallel group superiority trial with 1:1 randomization stratified by site with 3 months' follow-up was conducted at 9 sites across the United Kingdom and included participants with an idiopathic full-thickness macular hole of at least 400 μm minimum linear diameter and a duration of fewer than 12 months. All participants had vitrectomy surgery with peeling of the internal limiting membrane and injection of perfluoropropane (14%) gas, with or without simultaneous surgery for cataract.
Interventions


Following surgery, participants were randomly advised to position either facedown or face forward for 8 hours daily for 5 days.
Main Outcomes and Measures


The primary outcome was closure of the macular hole determined 3 months following surgery by masked optical coherence tomography evaluation. Secondary outcome measures at 3 months were visual acuity, participant-reported experience of positioning, and quality of life measured by the National Eye Institute Visual Function Questionnaire 25.
Results


A total of 185 participants (45 men [24.3%]; 156 white [84.3%]; 9 black [4.9%]; 10 Asian [5.4%]; median age, 69 years [interquartile range, 64-73 years]) were randomized. Macular hole closure was observed in 90 (85.6%) who were advised to position face forward and 88 (95.5%) advised to position facedown (adjusted odds ratio, 3.15; 95% CI, 0.87-11.41; P = .08). The mean (SD) improvement in best-corrected visual acuity at 3 months was 0.34 (0.69) logMAR (equivalent to 1 Snellen line) in the face-forward group and 0.57 (0.42) logMAR (equivalent to 3 Snellen lines) in the facedown group (adjusted mean difference, 0.22 [95 % CI, 0.05-0.38]; equivalent to 2 Snellen lines); 95% CI, 0.05-0.38; P = .01). The median National Eye Institute Visual Function Questionnaire 25 score was 89 (interquartile range, 76-94) in the facedown group and 87 (interquartile range, 73-93) in the face-forward group (mean [SD] change on a logistic scale, 0.08 [0.26] face forward and 0.11 [0.25] facedown; adjusted mean [SD] difference on a logistic scale, 0.02; 95% CI, -0.03 to 0.07; P = .41).
Conclusions and Relevance


The results do not prove that facedown positioning following surgery is more likely to close large macular holes compared with facing forward but do support the possibility that visual acuity outcomes may be superior.
Trial Registration


Isrctn.org Identifier: 12410596.",2020,The mean (SD) improvement in best-corrected visual acuity at 3 months was 0.34 (0.69) logMAR,"['participants with an idiopathic full-thickness macular hole of at least 400 μm minimum linear diameter and a duration of fewer than 12 months', 'A total of 185 participants (45 men [24.3%]; 156 white [84.3%]; 9 black [4.9%]; 10 Asian [5.4%]; median age, 69 years [interquartile range, 64-73 years', 'for Large Full-Thickness Macular Hole', 'All participants had vitrectomy surgery with peeling of the internal limiting membrane and injection of perfluoropropane (14%) gas, with or without simultaneous surgery for cataract']","['facedown or face forward for 8 hours daily for 5 days', 'logMAR', 'Facedown Positioning Following Surgery']","['mean (SD) improvement in best-corrected visual acuity', 'visual acuity, participant-reported experience of positioning, and quality of life measured by the National Eye Institute Visual Function Questionnaire 25', 'Macular hole closure', 'closure of the macular hole determined 3 months following surgery by masked optical coherence tomography evaluation', 'median National Eye Institute Visual Function Questionnaire 25 score']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C2733564', 'cui_str': 'Full thickness hole of macula lutea'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0937858', 'cui_str': 'Perflutren'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1955969', 'cui_str': 'National Eye Institute'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024441', 'cui_str': 'Macular hole'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",185.0,0.352625,The mean (SD) improvement in best-corrected visual acuity at 3 months was 0.34 (0.69) logMAR,"[{'ForeName': 'Saruban', 'Initials': 'S', 'LastName': 'Pasu', 'Affiliation': 'National Institute of Health Research Biomedical Research Centre (BRC), Moorfields Eye Hospital National Health Service (NHS) Foundation Trust, UCL Institute of Ophthalmology, London, England.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Bell', 'Affiliation': 'Pragmatic Clinical Trial Unit, Queen Mary University of London, London, England.'}, {'ForeName': 'Zohra', 'Initials': 'Z', 'LastName': 'Zenasni', 'Affiliation': 'Pragmatic Clinical Trial Unit, Queen Mary University of London, London, England.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Lanz', 'Affiliation': 'Pragmatic Clinical Trial Unit, Queen Mary University of London, London, England.'}, {'ForeName': 'Irene A', 'Initials': 'IA', 'LastName': 'Simmonds', 'Affiliation': 'Pragmatic Clinical Trial Unit, Queen Mary University of London, London, England.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Thompson', 'Affiliation': 'Pragmatic Clinical Trial Unit, Queen Mary University of London, London, England.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Yorston', 'Affiliation': 'Gartnavel Royal Hospital, Glasgow, Scotland.'}, {'ForeName': 'D Alistair H', 'Initials': 'DAH', 'LastName': 'Laidlaw', 'Affiliation': ""St Thomas' Hospital, London, England.""}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': 'National Institute of Health Research Biomedical Research Centre (BRC), Moorfields Eye Hospital National Health Service (NHS) Foundation Trust, UCL Institute of Ophthalmology, London, England.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hooper', 'Affiliation': 'Pragmatic Clinical Trial Unit, Queen Mary University of London, London, England.'}, {'ForeName': 'James W B', 'Initials': 'JWB', 'LastName': 'Bainbridge', 'Affiliation': 'National Institute of Health Research Biomedical Research Centre (BRC), Moorfields Eye Hospital National Health Service (NHS) Foundation Trust, UCL Institute of Ophthalmology, London, England.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.0987']
57,32382043,"Pregnancy rates after slow-release insemination (SRI) and standard bolus intrauterine insemination (IUI) - A multicentre randomised, controlled trial.","This multicentre, randomised, controlled cross-over trial was designed to investigate the effect of intra-uterine slow-release insemination (SRI) on pregnancy rates in women with confirmed infertility or the need for semen donation who were eligible for standard bolus intra-uterine insemination (IUI). Data for a total of 182 women were analysed after randomisation to receive IUI (n = 96) or SRI (n = 86) first. The primary outcome was serological pregnancy defined by a positive beta human chorionic gonadotropin test, two weeks after insemination. Patients who did not conceive after the first cycle switched to the alternative technique for the second cycle: 44 women switched to IUI and 58 switched to SRI. In total, there were 284 treatment cycles (IUI: n = 140; SRI: n = 144). Pregnancy rates following SRI and IUI were 13.2% and 10.0%, respectively, which was not statistically significant (p = 0.202). A statistically significant difference in pregnancy rates for SRI versus IUI was detected in women aged under 35 years. In this subgroup, the pregnancy rate with SRI was 17% compared to 7% with IUI (relative risk 2.33; p = 0.032) across both cycles. These results support the hypothesis that the pregnancy rate might be improved with SRI compared to standard bolus IUI, especially in women aged under 35 years.",2020,"Pregnancy rates following SRI and IUI were 13.2% and 10.0%, respectively, which was not statistically significant (p = 0.202).","['Patients who did not conceive after the first cycle switched to the alternative technique for the second cycle: 44 women switched to IUI and 58 switched to SRI', 'women aged under 35 years', '182 women', 'women with confirmed infertility or the need for semen donation who were eligible for standard bolus intra-uterine insemination (IUI']","['slow-release insemination (SRI) and standard bolus intrauterine insemination (IUI) ', 'SRI', 'intra-uterine slow-release insemination (SRI']","['pregnancy rate with SRI', 'serological pregnancy defined by a positive beta human chorionic gonadotropin test', 'pregnancy rates', 'Pregnancy rates', 'Pregnancy rates following SRI and IUI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0021586', 'cui_str': 'Insemination'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0021586', 'cui_str': 'Insemination'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0021586', 'cui_str': 'Insemination'}, {'cui': 'C0205473', 'cui_str': 'Serologic'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0106132', 'cui_str': 'Human chorionic gonadotropin, beta subunit'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}]",182.0,0.269693,"Pregnancy rates following SRI and IUI were 13.2% and 10.0%, respectively, which was not statistically significant (p = 0.202).","[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Marschalek', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Egarter', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Vytiska-Binsdorfer', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Obruca', 'Affiliation': 'Kinderwunschzentrum Goldenes Kreuz, Lazarettgasse 16, 1090, Vienna, Austria.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Campbell', 'Affiliation': 'Faculty of Health and Society, University of Northampton, Northampton, NN2 7AL, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Harris', 'Affiliation': 'Department of Gynaecology, Wrightington Hospital, Wigan, Lancashire, WN6 9EP, UK.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'van Santen', 'Affiliation': 'Private Office and Spermbank, Kriegsstrasse 216, 76135, Karlsruhe, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Lesoine', 'Affiliation': 'A.R.T. Bogenhausen, Prinzregentenstraße 69, 81675, Munich, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Ott', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Franz', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria. mf@gyn-bogenhausen.de.'}]",Scientific reports,['10.1038/s41598-020-64164-4']
58,32379976,The Benefits of  T'ai Chi  for Older Adults with Chronic Back Pain: A Qualitative Study.,"Objective:  To determine the perceived benefits of  t'ai chi  in older adults with chronic low-back pain (cLBP).  Design:  A qualitative analysis from a randomized controlled feasibility trial.  Subjects:  Eighteen participants (65+ years old) with cLBP of at least moderate intensity.  Intervention:  A 36-week intervention beginning with twice weekly classes for 12 weeks, weekly classes for 6 weeks, biweekly classes for 6 weeks, and monthly classes for 12 weeks. Participants were asked to practice at home on nonclass days and videos were provided to assist in that process.  Outcome Measures:  Participants in the focus groups were asked to provide feedback on their experiences with the study as well as the benefits of their  t'ai chi  practice. We used demographic and class attendance data to describe the sample.  Results:  Regarding the benefits of  t'ai chi  practice, five major themes were identified: functional benefits, pain reduction/pain relief, psychospiritual benefits, the importance of social support in learning  t'ai chi , and the integration of  t'ai chi  into daily activities. The most common functional benefits were improvements in balance, flexibility, leg strength, and posture. Some reported pain reduction or pain relief, but others did not. Increased relaxation, mindfulness, and a sense of connectedness were subthemes that emerged from psychospiritual benefits. Social support benefits included motivation to attend class and group support while learning a new skill. Finally, improved body awareness allowed participants to integrate  t'ai chi  skills into their daily activities.  Conclusions:  This qualitative analysis demonstrates the multifaceted benefits of  t'ai chi  for older adults living with cLBP.",2020,"The most common functional benefits were improvements in balance, flexibility, leg strength, and posture.","['Subjects:  Eighteen participants (65+ years old) with cLBP of at least moderate intensity', 'older adults living with cLBP', 'older adults with chronic low-back pain (cLBP', 'Older Adults with Chronic Back Pain']","[""T'ai Chi"", ""t'ai chi  practice""]","['pain reduction or pain relief', ""functional benefits, pain reduction/pain relief, psychospiritual benefits, the importance of social support in learning  t'ai chi , and the integration of  t'ai chi  into daily activities"", 'balance, flexibility, leg strength, and posture']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}]",,0.0522767,"The most common functional benefits were improvements in balance, flexibility, leg strength, and posture.","[{'ForeName': 'Tamsin L', 'Initials': 'TL', 'LastName': 'Lee', 'Affiliation': 'Department of Child, Family and Population Health Nursing, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Sherman', 'Affiliation': 'Kaiser Permanente WA Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Rene J', 'Initials': 'RJ', 'LastName': 'Hawkes', 'Affiliation': 'Kaiser Permanente WA Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Phelan', 'Affiliation': 'Department of Medicine and Health Services, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Turner', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences and University of Washington School of Medicine, Seattle, WA, USA.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0455']
59,32381018,"Trastuzumab, pertuzumab, and eribulin mesylate versus trastuzumab, pertuzumab, and a taxane as a first-line or second-line treatment for HER2-positive, locally advanced or metastatic breast cancer: study protocol for a randomized controlled, non-inferiority, phase III trial in Japan (JBCRG-M06/EMERALD).","BACKGROUND


Trastuzumab (Tmab), pertuzumab (Pmab), and taxane has been a standard first-line treatment for recurrent or metastatic human epidermal growth factor (HER2)-positive breast cancer (HER2 +  mBC) but has some safety issues due to taxane-induced toxicities. This has led to ongoing efforts to seek less toxic alternatives to taxanes that are equally effective when used in combination with Tmab plus Pmab. This study aims to show the non-inferiority of eribulin, a non-taxane microtubule inhibitor, against taxane, as a partner for dual HER2 blockade.
METHODS/DESIGN


This multicenter, randomized, open-label, parallel-group, phase III study will involve a total of 480 Japanese women with HER2 +  mBC who meet the following requirements: (1) age 20-70 years; (2) no prior cytotoxic chemotherapy (excluding trastuzumab-emtansine) for mBC; (3) ≥ 6 months after prior neoadjuvant or adjuvant cytotoxic chemotherapy; (4) presence of any radiologically evaluable lesion; (5) left ventricular ejection fraction ≥ 50%; (6) Eastern Cooperative Oncology Group performance status score of 0 or 1; (7) adequate organ function; and (8) life expectancy of at least 6 months. They will be randomized 1:1 to receive eribulin (1.4 mg/m 2  on days 1 and 8) or taxane (docetaxel 75 mg/m 2  on day 1 or paclitaxel 80 mg/m 2  on days 1, 8, and 15) in combination with Tmab (8 mg/kg then 6 mg/kg) plus Pmab (840 mg then 420 mg) on day 1 of each 21-day cycle. The treatment will be continued until disease progression or unmanageable toxicity. The primary endpoint is progression-free survival as per investigator according to RECIST v1.1 criteria. Key secondary endpoints include objective response rate, overall survival, quality of life and safety. Non-inferiority will be tested with two margins of 1.33 and 1.25 in a stepwise manner. If non-inferiority is shown with a margin of 1.25, superiority will then be tested.
DISCUSSION


If this study shows the non-inferiority, or even superiority, of Tmab, Pmab, and eribulin against the existing taxane-containing regimen, this new regimen may become a standard first- or second-line treatment option for HER2 +  mBC in Japan.
TRIAL REGISTRATION


ClinicalTrials.gov, ID: NCT03264547. Registered on 28 June 2017.",2020,"If this study shows the non-inferiority, or even superiority, of Tmab, Pmab, and eribulin against the existing taxane-containing regimen, this new regimen may become a standard first- or second-line treatment option for HER2 +  mBC in Japan.
","['HER2-positive, locally advanced or metastatic breast cancer', '480 Japanese women with HER2 +  mBC who meet the following requirements: (1) age 20-70\u2009years; (2) no prior']","['cytotoxic chemotherapy (excluding trastuzumab-emtansine) for mBC; (3) ≥', 'taxane (docetaxel 75 mg/m 2  on day 1 or paclitaxel 80 mg', 'Trastuzumab, pertuzumab, and eribulin mesylate versus trastuzumab, pertuzumab, and a taxane', 'Trastuzumab (Tmab), pertuzumab (Pmab), and taxane', 'plus Pmab', 'taxane microtubule inhibitor, against taxane', 'adjuvant cytotoxic chemotherapy']","['progression-free survival', 'objective response rate, overall survival, quality of life and safety']","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0065839', 'cui_str': 'Carbendazim'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C0065839', 'cui_str': 'Carbendazim'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C2608038', 'cui_str': 'Eribulin mesylate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1563757', 'cui_str': 'Microtubule inhibitor-containing product'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",480.0,0.102615,"If this study shows the non-inferiority, or even superiority, of Tmab, Pmab, and eribulin against the existing taxane-containing regimen, this new regimen may become a standard first- or second-line treatment option for HER2 +  mBC in Japan.
","[{'ForeName': 'Toshinari', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Department of Breast Surgery, Kanagawa Cancer Center, 2-3-2 Nakao Asahi-ku, Yokohama-shi, Kanagawa, 241-8515, Japan. tyamashita@kcch.jp.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': 'Department of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, 2-1-14 Hoenzaka, Chuou-ku, Osaka, 540-0006, Japan.'}, {'ForeName': 'Shigehira', 'Initials': 'S', 'LastName': 'Saji', 'Affiliation': 'Department of Medical Oncology, Fukushima Medical University, 1 Hikarigaoka Fukushima, Fukushima, 960-1295, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Araki', 'Affiliation': 'Department of Breast Surgery, Gunma Prefectural Cancer Center, 617-1 Takahayashinishicho, Ota, Gunma, 373-8550, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Breast Medical Oncology, Breast Oncology Center, The Cancer Institute Hospital of JFCR, 3-8-31 Ariake Koto-ku, Tokyo, 135-8550, Japan.'}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Takano', 'Affiliation': 'Department of Medical Oncology, Toranomon Hospital, 2-2-2 Toranomon Minato-ku, Tokyo, 105-8470, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Breast Surgery, NHO Hokkaido Cancer Center, 2-3-54 Yonjyo Kikusui Shiraishi-ku, Sapporo-shi, Hokkaido, 003-0804, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Tsurutani', 'Affiliation': 'Department of Medical Oncology, Showa University Hospital, 1-5-8 Hatanodai Shinagawa-ku, Tokyo, 142-8666, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Koizumi', 'Affiliation': 'First Department of Surgery, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka, 431-3192, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Kitada', 'Affiliation': 'Breast Disease Center, Asahikawa Medical University Hospital, 1-1 Higashi 2-jyo 1-chome, Midorigaoka, Asahikawa-shi, Hokkaido, 078-8510, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Kojima', 'Affiliation': 'Department of Breast Surgery, St. Marianna University School of Medicine Hospital, 2-16-1 Sugao Miyamae-ku, Kawasaki-shi, Kanagawa, 216-8511, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Sagara', 'Affiliation': 'Breast Surgical Oncology, Sagara Hospital, 3-31 Matsubaracho Kagoshima-shi, Kagoshima, 892-0833, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tada', 'Affiliation': 'Department of Breast and Endocrine Surgical Oncology, Tohoku University Hospital, 1-1 Seiryocho Aoba-ku Sendai-shi, Miyagi, 980-8574, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Iwasa', 'Affiliation': 'Oncology Internal Medicine, Kindai University Hospital, 377-2 Ohnohigashi Sayama-shi Osaka, Osaka, 589-8511, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Kadoya', 'Affiliation': 'Breast Surgery, Hiroshima University Hospital, 1-2-3 Kasumi Minami-ku Hiroshima-shi, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Tsuguo', 'Initials': 'T', 'LastName': 'Iwatani', 'Affiliation': 'Department of Breast Surgery, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hasegawa', 'Affiliation': 'Eisai Co., Ltd., 4-6-10 Koishikawa Bunkyo-ku, Tokyo, 112-8088, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine Kyoto University, 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Ohno', 'Affiliation': 'Breast Oncology Center, The Cancer Institute Hospital of JFCR, 3-8-31 Ariake Koto-ku, Tokyo, 135-8550, Japan.'}]",Trials,['10.1186/s13063-020-04341-y']
60,32381030,Graphing and reporting heterogeneous treatment effects through reference classes.,"BACKGROUND


Exploration and modelling of heterogeneous treatment effects as a function of baseline covariates is an important aspect of precision medicine in randomised controlled trials (RCTs). Randomisation generally guarantees the internal validity of an RCT, but heterogeneity in treatment effect can reduce external validity. Estimation of heterogeneous treatment effects is usually done via a predictive model for individual outcomes, where one searches for interactions between treatment allocation and important patient baseline covariates. However, such models are prone to overfitting and multiple testing and typically demand a transformation of the outcome measurement, for example, from the absolute risk in the original RCT to log-odds of risk in the predictive model.
METHODS


We show how reference classes derived from baseline covariates can be used to explore heterogeneous treatment effects via a two-stage approach. We first estimate a risk score which captures on a single dimension some of the heterogeneity in outcomes of the trial population. Heterogeneity in the treatment effect can then be explored via reweighting schemes along this axis of variation. This two-stage approach bypasses the search for interactions with multiple covariates, thus protecting against multiple testing. It also allows for exploration of heterogeneous treatment effects on the original outcome scale of the RCT. This approach would typically be applied to multivariable models of baseline risk to assess the stability of average treatment effects with respect to the distribution of risk in the population studied.
CASE STUDY


We illustrate this approach using the single largest randomised treatment trial in severe falciparum malaria and demonstrate how the estimated treatment effect in terms of absolute mortality risk reduction increases considerably in higher risk strata.
CONCLUSIONS


'Local' and 'tilting' reweighting schemes based on ranking patients by baseline risk can be used as a general approach for exploring, graphing and reporting heterogeneity of treatment effect in RCTs.
TRIAL REGISTRATION


ISRCTN clinical trials registry: ISRCTN50258054. Prospectively registered on 22 July 2005.",2020,"Estimation of heterogeneous treatment effects is usually done via a predictive model for individual outcomes, where one searches for interactions between treatment allocation and important patient baseline covariates.",['Prospectively registered on 22 July 2005'],[],['external validity'],"[{'cui': 'C0600375', 'cui_str': 'Registers'}]",[],"[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}]",,0.0905911,"Estimation of heterogeneous treatment effects is usually done via a predictive model for individual outcomes, where one searches for interactions between treatment allocation and important patient baseline covariates.","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Watson', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, 10400, Thailand. jwatowatson@gmail.com.'}, {'ForeName': 'Chris C', 'Initials': 'CC', 'LastName': 'Holmes', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK. cholmes@stats.ox.ac.uk.'}]",Trials,['10.1186/s13063-020-04306-1']
61,32381031,Care after pancreatic resection according to an algorithm for early detection and minimally invasive management of pancreatic fistula versus current practice (PORSCH-trial): design and rationale of a nationwide stepped-wedge cluster-randomized trial.,"BACKGROUND


Pancreatic resection is a major abdominal operation with 50% risk of postoperative complications. A common complication is pancreatic fistula, which may have severe clinical consequences such as postoperative bleeding, organ failure and death. The objective of this study is to investigate whether implementation of an algorithm for early detection and minimally invasive management of pancreatic fistula may improve outcomes after pancreatic resection.
METHODS


This is a nationwide stepped-wedge, cluster-randomized, superiority trial, designed in adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. During a period of 22 months, all Dutch centers performing pancreatic surgery will cross over in a randomized order from current practice to best practice according to the algorithm. This evidence-based and consensus-based algorithm will provide daily multilevel advice on the management of patients after pancreatic resection (i.e. indication for abdominal imaging, antibiotic treatment, percutaneous drainage and removal of abdominal drains). The algorithm is designed to aid early detection and minimally invasive step-up management of postoperative pancreatic fistula. Outcomes of current practice will be compared with outcomes after implementation of the algorithm. The primary outcome is a composite of major complications (i.e. post-pancreatectomy bleeding, new-onset organ failure and death) and will be measured in a sample size of at least 1600 patients undergoing pancreatic resection. Secondary endpoints include the individual components of the primary endpoint and other clinical outcomes, healthcare resource utilization and costs analysis. Follow up will be up to 90 days after pancreatic resection.
DISCUSSION


It is hypothesized that a structured nationwide implementation of a dedicated algorithm for early detection and minimally invasive step-up management of postoperative pancreatic fistula will reduce the risk of major complications and death after pancreatic resection, as compared to current practice.
TRIAL REGISTRATION


Netherlands Trial Register: NL 6671. Registered on 16 December 2017.",2020,"This evidence-based and consensus-based algorithm will provide daily multilevel advice on the management of patients after pancreatic resection (i.e. indication for abdominal imaging, antibiotic treatment, percutaneous drainage and removal of abdominal drains).",[],[],"['composite of major complications (i.e. post-pancreatectomy bleeding, new-onset organ failure and death', 'individual components of the primary endpoint and other clinical outcomes, healthcare resource utilization and costs analysis']",[],[],"[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030279', 'cui_str': 'Pancreatectomy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010171', 'cui_str': 'Analysis, Cost'}]",1600.0,0.148272,"This evidence-based and consensus-based algorithm will provide daily multilevel advice on the management of patients after pancreatic resection (i.e. indication for abdominal imaging, antibiotic treatment, percutaneous drainage and removal of abdominal drains).","[{'ForeName': 'F Jasmijn', 'Initials': 'FJ', 'LastName': 'Smits', 'Affiliation': 'Department of Surgery, Regional Academic Cancer Center Utrecht, St. Antonius Hospital and University Medical Center Utrecht, PO Box 85500, Utrecht, 3508, GA, The Netherlands.'}, {'ForeName': 'Anne Claire', 'Initials': 'AC', 'LastName': 'Henry', 'Affiliation': 'Department of Surgery, Regional Academic Cancer Center Utrecht, St. Antonius Hospital and University Medical Center Utrecht, PO Box 85500, Utrecht, 3508, GA, The Netherlands.'}, {'ForeName': 'Casper H', 'Initials': 'CH', 'LastName': 'van Eijck', 'Affiliation': 'Department of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Marc G', 'Initials': 'MG', 'LastName': 'Besselink', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Olivier R', 'Initials': 'OR', 'LastName': 'Busch', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Arntz', 'Affiliation': 'Department of Radiology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Bollen', 'Affiliation': 'Department of Radiology, St. Antoniusziekenhuis, Nieuwegein, The Netherlands.'}, {'ForeName': 'Otto M', 'Initials': 'OM', 'LastName': 'van Delden', 'Affiliation': 'Department of Radiology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'van den Heuvel', 'Affiliation': 'Department of Radiology, St. Antoniusziekenhuis, Nieuwegein, The Netherlands.'}, {'ForeName': 'Christiaan', 'Initials': 'C', 'LastName': 'van der Leij', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Krijn P', 'Initials': 'KP', 'LastName': 'van Lienden', 'Affiliation': 'Department of Radiology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Adriaan', 'Initials': 'A', 'LastName': 'Moelker', 'Affiliation': 'Department of Radiology, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Bert A', 'Initials': 'BA', 'LastName': 'Bonsing', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Inne H M', 'Initials': 'IHM', 'LastName': 'Borel Rinkes', 'Affiliation': 'Department of Surgery, Regional Academic Cancer Center Utrecht, St. Antonius Hospital and University Medical Center Utrecht, PO Box 85500, Utrecht, 3508, GA, The Netherlands.'}, {'ForeName': 'Koop', 'Initials': 'K', 'LastName': 'Bosscha', 'Affiliation': 'Department of Surgery, Jeroen Bosch Ziekenhuis, ´s-Hertogenbosch, The Netherlands.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'van Dam', 'Affiliation': 'Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Festen', 'Affiliation': 'Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Groot Koerkamp', 'Affiliation': 'Department of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Erwin', 'Initials': 'E', 'LastName': 'van der Harst', 'Affiliation': 'Department of Surgery, Maasstad Ziekenhuis, Rotterdam, The Netherlands.'}, {'ForeName': 'Ignace H', 'Initials': 'IH', 'LastName': 'de Hingh', 'Affiliation': 'Department of Surgery, Catharina Ziekenhuis, Eindhoven, The Netherlands.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Kazemier', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, VU University, Amsterdam, The Netherlands.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Liem', 'Affiliation': 'Department of Surgery, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'B Marion', 'Initials': 'BM', 'LastName': 'van der Kolk', 'Affiliation': 'Department of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Vincent E', 'Initials': 'VE', 'LastName': 'de Meijer', 'Affiliation': 'Department of Surgery, University of Groningen and University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Gijs A', 'Initials': 'GA', 'LastName': 'Patijn', 'Affiliation': 'Department of Surgery, Isala Ziekenhuis, Zwolle, The Netherlands.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Roos', 'Affiliation': 'Department of Surgery, Reinier de Graaf Gasthuis, Delft, The Netherlands.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Schreinemakers', 'Affiliation': 'Department of Surgery, Amphia Ziekenhuis, Breda, The Netherlands.'}, {'ForeName': 'Fennie', 'Initials': 'F', 'LastName': 'Wit', 'Affiliation': 'Department of Surgery, Tjongerschans, Heerenveen, The Netherlands.'}, {'ForeName': 'C Henri', 'Initials': 'CH', 'LastName': 'van Werkhoven', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'I Quintus', 'Initials': 'IQ', 'LastName': 'Molenaar', 'Affiliation': 'Department of Surgery, Regional Academic Cancer Center Utrecht, St. Antonius Hospital and University Medical Center Utrecht, PO Box 85500, Utrecht, 3508, GA, The Netherlands.'}, {'ForeName': 'Hjalmar C', 'Initials': 'HC', 'LastName': 'van Santvoort', 'Affiliation': 'Department of Surgery, Regional Academic Cancer Center Utrecht, St. Antonius Hospital and University Medical Center Utrecht, PO Box 85500, Utrecht, 3508, GA, The Netherlands. h.vansantvoort@umcutrecht.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-4167-9']
62,32381052,Translation of two healthy eating and active living support programs for parents of 2-6 year old children: a parallel partially randomised preference trial protocol (the 'time for healthy habits' trial).,"BACKGROUND


Parents are key decision makers and role models in establishing and maintaining healthy behaviours in their children. Interventions involving parents have been shown to be more effective than those that do not, but there are barriers to participation. Efficacy trials have previously been conducted on two such parent-focussed healthy eating and active living interventions with the potential to overcome these barriers - Healthy Habits (telephone-based) and Time2bHealthy (online) with promising results. Further research is now required to determine the effectiveness of these interventions in a real-world context. The Time for Healthy Habits study is a 3-arm partially randomised preference trial which aims to evaluate the effectiveness and cost-effectiveness of two theory-based programs to promote healthy eating and appropriate levels of movement behaviours (physical activity, sedentary behaviour and sleep) for parents of 2- to 6-year-old children (Healthy Habits Plus telephone-based program and Time2bHealthy online program), when compared to a comparison group receiving written materials.
METHODS


Participants will be recruited across five Local Health Districts in New South Wales, Australia. The partially randomised preference design initially allows for participants to decide if they wish to be randomised or opt to select their preferred intervention and has been recommended for use to test effectiveness in a real-world setting. Both interventions incorporate multiple behaviour change techniques and support parents to improve their children's healthy eating, and movement behaviours (physical activity, sedentary behaviour and sleep) and run for 12 weeks, followed by a 3-month and 9-month post-baseline follow-up. Participants will also be asked to complete a process evaluation questionnaire at the completion of the intervention (3-months post-baseline). Outcomes include fruit and vegetable intake (primary outcome), non-core food intake, weight status, physical activity, sedentary behaviour, and sleep habits.
DISCUSSION


To our knowledge, this is the first translational research trial evaluating the effectiveness and cost-effectiveness of a healthy eating and active living intervention in the 2- to 6-years age group. The results will build the evidence base in regard to translation of effective childhood obesity prevention interventions and inform the implementation and delivery of community based childhood obesity prevention programs.
TRIAL REGISTRATION


UTN: U1111-1228-9748, ACTRN: 12619000396123p.",2020,"Both interventions incorporate multiple behaviour change techniques and support parents to improve their children's healthy eating, and movement behaviours (physical activity, sedentary behaviour and sleep) and run for 12 weeks, followed by a 3-month and 9-month post-baseline follow-up.","['parents of 2- to 6-year-old children (Healthy Habits Plus', 'two healthy eating and active living support programs for parents of 2-6\u2009year old children', 'Participants will be recruited across five Local Health Districts in New South Wales, Australia']","['comparison group receiving written materials', 'healthy eating and active living intervention', 'telephone-based program and Time2bHealthy online program']","['healthy eating and appropriate levels of movement behaviours (physical activity, sedentary behaviour and sleep', 'effectiveness and cost-effectiveness', 'fruit and vegetable intake (primary outcome), non-core food intake, weight status, physical activity, sedentary behaviour, and sleep habits', ""children's healthy eating, and movement behaviours (physical activity, sedentary behaviour and sleep""]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C2133558', 'cui_str': 'Sleep Habits'}, {'cui': 'C0686744', 'cui_str': 'Well child'}]",,0.0710845,"Both interventions incorporate multiple behaviour change techniques and support parents to improve their children's healthy eating, and movement behaviours (physical activity, sedentary behaviour and sleep) and run for 12 weeks, followed by a 3-month and 9-month post-baseline follow-up.","[{'ForeName': 'Megan L', 'Initials': 'ML', 'LastName': 'Hammersley', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong, Northfields Ave, Wollongong, NSW, 2522, Australia. mhammers@uow.edu.au.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Wyse', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, NSW, 2308, Australia.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Jones', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong, Northfields Ave, Wollongong, NSW, 2522, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wolfenden', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, NSW, 2308, Australia.'}, {'ForeName': 'Serene', 'Initials': 'S', 'LastName': 'Yoong', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, NSW, 2308, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Stacey', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, NSW, 2308, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Eckermann', 'Affiliation': 'Australian Health Services Research Institute, University of Wollongong, Northfields Ave, Wollongong, NSW, 2522, Australia.'}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Okely', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong, Northfields Ave, Wollongong, NSW, 2522, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Innes-Hughes', 'Affiliation': 'NSW Office of Preventive Health, Liverpool Hospital, Locked Bag 7103, Liverpool BC, Sydney, NSW, Australia.'}, {'ForeName': 'Vincy', 'Initials': 'V', 'LastName': 'Li', 'Affiliation': 'NSW Office of Preventive Health, Liverpool Hospital, Locked Bag 7103, Liverpool BC, Sydney, NSW, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Green', 'Affiliation': 'NSW Office of Preventive Health, Liverpool Hospital, Locked Bag 7103, Liverpool BC, Sydney, NSW, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'May', 'Affiliation': 'Formerly Murrumbidgee Local Health District, Cootamundra Health Service, McKay St, Cootamundra, NSW, Australia.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'NSW Office of Preventive Health, Liverpool Hospital, Locked Bag 7103, Liverpool BC, Sydney, NSW, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rissel', 'Affiliation': 'NSW Office of Preventive Health, Liverpool Hospital, Locked Bag 7103, Liverpool BC, Sydney, NSW, Australia.'}]",BMC public health,['10.1186/s12889-020-08526-7']
63,32381097,"Survive and Thrive in Brazil: The Boa Vista Early Childhood Program: study protocol of a stepped-wedge, randomized controlled trial.","BACKGROUND


A growing body of evidence suggests that early life health and developmental outcomes can be improved through parental support programs. The objective of this project was to test the feasibility, impact, and relative cost-effectiveness of an adapted ""Reach Up and Learn"" program delivered through home-visiting programs as well as through center-based parenting groups on child health and development in the municipality of Boa Vista, Brazil.
METHODS


A randomized, stepped-wedge design was used to roll out and evaluate the two parenting platforms in Boa Vista municipality. A total of 39 neighborhoods with a high Neighborhood Vulnerability Index were selected for the study. For the first phase of the program, nine neighborhoods were randomly selected for home visits, and two were randomly selected for the center-based parenting groups. In the second phase of the program, 10 neighborhoods were added to the home-visiting program, and eight were added to the center-based program. In the final phase of the program, the remaining 10 control areas will also be assigned to treatment. Study eligibility will be assessed through a baseline survey completed by all pregnant women in the 39 study areas. Pregnant women will be eligible to participate in the study if they are either classified as poor, were under age 20 years when they became pregnant, or if they indicate to have been exposed to domestic or sexual violence. To assess program impact, an endline survey will be conducted when children reach age 2 years. The primary study outcome is child development at age 2 years as measured by the PRIDI instrument. Secondary outcome will be infant mortality, which will be assessed linking municipal vital registration systems to the program rollout.
DISCUSSION


This trial will assess the feasibility and impact of parenting programs rolled out at medium scale. The results from the trial should create evidence urgently needed for guiding Brazil's national Criança Feliz program as well as similar efforts in other countries.
TRIAL REGISTRATION


ClinicalTrials.gov, ID: NCT03386747. Registered on 13 December 2017. All items of the World Health Organization Trial Registration Data Set are available in this record.",2020,"The objective of this project was to test the feasibility, impact, and relative cost-effectiveness of an adapted ""Reach Up and Learn"" program delivered through home-visiting programs as well as through center-based parenting groups on child health and development in the municipality of Boa Vista, Brazil.
","['Survive and Thrive in Brazil', '39 neighborhoods with a high Neighborhood Vulnerability Index', 'two parenting platforms in Boa Vista municipality', 'pregnant women in the 39 study areas', 'children reach age 2 years', 'Pregnant women']","['adapted ""Reach Up and Learn"" program']","['infant mortality, which will be assessed linking municipal vital registration systems to the program rollout', 'child development at age 2 years as measured by the PRIDI instrument']","[{'cui': 'C2938208', 'cui_str': 'Thrive'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0006506', 'cui_str': 'Butylated Hydroxyanisole'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0021278', 'cui_str': 'Mortality, Infant'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]",39.0,0.0711104,"The objective of this project was to test the feasibility, impact, and relative cost-effectiveness of an adapted ""Reach Up and Learn"" program delivered through home-visiting programs as well as through center-based parenting groups on child health and development in the municipality of Boa Vista, Brazil.
","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Brentani', 'Affiliation': 'Department of Pediatrics, University of São Paulo Medical School, Av. Dr. Emeas de Carvalho Aguiar, 467, São Paulo, Brazil. alexandra@usp.br.'}, {'ForeName': 'Ana Paula Scolezze', 'Initials': 'APS', 'LastName': 'Ferrer', 'Affiliation': 'Department of Pediatrics, University of São Paulo Medical School, Av. Dr. Emeas de Carvalho Aguiar, 467, São Paulo, Brazil.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Bessa', 'Affiliation': 'Department of Pediatrics, University of São Paulo Medical School, Av. Dr. Emeas de Carvalho Aguiar, 467, São Paulo, Brazil.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Chang', 'Affiliation': 'Caribbean Institute of Health Research, University of the West Indies, Kingston, 7, WI, Jamaica.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Walker', 'Affiliation': 'Caribbean Institute of Health Research, University of the West Indies, Kingston, 7, WI, Jamaica.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Powell', 'Affiliation': 'Caribbean Institute of Health Research, University of the West Indies, Kingston, 7, WI, Jamaica.'}, {'ForeName': 'Jena', 'Initials': 'J', 'LastName': 'Hamadani', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, 68 Shaheed Tajuddin Ahmed Sarani Mohakhali, Dhaka, 1212, Bangladesh.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Grisi', 'Affiliation': 'Department of Pediatrics, University of São Paulo Medical School, Av. Dr. Emeas de Carvalho Aguiar, 467, São Paulo, Brazil.'}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Fink', 'Affiliation': 'Department of Epidemiology and Public Health, Swiss TPH and University of Basel, Socintrasse 57, 4002, Basel, Switzerland.'}]",Trials,['10.1186/s13063-020-4217-3']
64,32384885,Effects of reflection and immediate feedback to improve clinical reasoning of medical students in the assessment of dermatologic conditions: a randomised controlled trial.,"BACKGROUND


There are few studies that directly compared different interventions to improve medical students' clinical reasoning for dermatologic conditions.
OBJECTIVE


To investigate the effectiveness of adding practice with reflection and immediate feedback on traditional dermatology electives in improving medical students' ability in evaluating skin lesions.
METHODS


The participants were fourth-year medical students of Seoul National University College of Medicine, Korea, who were enrolled to take a 2-week dermatology elective course (n = 87). Students were assigned to one of the three educational interventions: 2-h training involving 10 written clinical cases (experimental); 1-h lecture and 1-h outpatient clinic (lecture); and 2-h outpatient clinic (no intervention). Before and at the end of rotation, diagnostic accuracy was estimated using 20 written clinical cases with photographs (10 novel cases presented in diagnostic training [training set], 10 cases with diagnoses not included in training [control set]).
RESULTS


There was a significant interaction effect of intervention×set×time. A post hoc analysis indicated that the students in the experimental group outperformed students in the other two groups only in the training set of the final tests; after completing the 2-week rotation, for the training set, the mean score was higher in the experimental group (7.5 ± 1.3) than in the lecture (5.7 ± 1.6) and no intervention (5.6 ± 1.3) groups, producing an effect size of 1.2 standard deviation (SD) and 1.5 SD, respectively.
CONCLUSION


Practicing written clinical cases with reflection and feedback is superior to a lecture-based approach and yields additional benefits to a dermatology elective, thereby enhancing medical students' ability to accurately diagnose skin lesions.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03472001. Registered 21 March 2018.",2020,"A post hoc analysis indicated that the students in the experimental group outperformed students in the other two groups only in the training set of the final tests; after completing the 2-week rotation, for the training set, the mean score was higher in the experimental group (7.5 ± 1.3) than in the lecture (5.7 ± 1.6) and no intervention (5.6 ± 1.3) groups, producing an effect size of 1.2 standard deviation (SD) and 1.5 SD, respectively.
","['participants were fourth-year medical students of Seoul National University College of Medicine, Korea, who were enrolled to take a 2-week dermatology elective course (n\u2009=\u200987', 'medical students in the assessment of dermatologic conditions']","['educational interventions: 2-h training involving 10 written clinical cases (experimental); 1-h lecture and 1-h outpatient clinic (lecture); and 2-h outpatient clinic (no intervention', 'practice with reflection and immediate feedback', 'reflection and immediate feedback']",['mean score'],"[{'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",10.0,0.0374438,"A post hoc analysis indicated that the students in the experimental group outperformed students in the other two groups only in the training set of the final tests; after completing the 2-week rotation, for the training set, the mean score was higher in the experimental group (7.5 ± 1.3) than in the lecture (5.7 ± 1.6) and no intervention (5.6 ± 1.3) groups, producing an effect size of 1.2 standard deviation (SD) and 1.5 SD, respectively.
","[{'ForeName': 'Sungjun', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': 'Department of Dermatology, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Sohee', 'Initials': 'S', 'LastName': 'Oh', 'Affiliation': 'Department of Biostatistics, SMG-SNU Boramae Medical Center, Seoul, South Korea.'}, {'ForeName': 'Dong Hun', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyun-Sun', 'Initials': 'HS', 'LastName': 'Yoon', 'Affiliation': 'Department of Dermatology, SMG-SNU Boramae Medical Center, 20, Boramae-ro 5-gil, Dongjak-gu, Seoul, 07061, South Korea. hsyoon79@gmail.com.'}]",BMC medical education,['10.1186/s12909-020-02063-y']
65,32384905,Foot exercise plus education versus wait and see for the treatment of plantar heel pain (FEET trial): a protocol for a feasibility study.,"BACKGROUND


Plantar heel pain (PHP) is present in a wide range of individuals and creates significant burden to quality of life and participation in physical activity. The high recurrence rates and persistence of PHP suggests current management options may not address all potentially modifiable factors associated with the condition. Reports of intrinsic foot muscle (IFM) atrophy in individuals with PHP, together with biomechanical evidence of their important contribution to optimal foot function, suggests that an intervention focused on IFM training may be beneficial in managing PHP. We will test the feasibility of a prospective, assessor-blinded, parallel-group, randomised clinical trial that compares foot exercise plus education to brief advice in individuals with PHP.
METHODS


Twenty participants with PHP will be randomly allocated to one of two groups for a 12-week intervention period: (i) foot exercise plus education, or (ii) brief advice. The foot exercise plus education group will attend eight sessions with a physiotherapist and receive detailed education on self-management strategies as well as a progressive exercise program for the IFMs. The brief advice group will attend one session with a physiotherapist and receive brief information about self-management strategies and reassurance. Outcome measures will be obtained at baseline and the primary end-point of 12 weeks. Primary outcomes will be the feasibility of conducting a full-scale randomised clinical trial (RCT), and the credibility and acceptability of the foot exercise plus education intervention. Secondary outcomes will explore treatment effects, which will consist of pain, physical function, physical activity level, pain self-efficacy, perceived treatment effect, magnetic resonance and ultrasound image measurement of IFM morphology, ultrasound imaging measurement of plantar fascia thickness, IFM motor performance, foot posture, foot mobility, ankle dorsiflexion range of motion, toe flexor and plantar flexor strength/endurance.
DISCUSSION


To reduce the burden of PHP on individuals and society, there is a need to establish effective treatments that are feasible and accepted by patients and health professionals. This trial will be the first to evaluate the feasibility of conducting a full-scale RCT, as well as the credibility, acceptability, and treatment effects, of education and foot exercise for PHP. The findings of this study will inform the development of a full-scale RCT.
TRIAL REGISTRATION


The trial protocol was prospectively registered with the Australia and New Zealand Clinical Trial Registry (ACTRN12619000987167) on 11th July 2019.",2020,"Primary outcomes will be the feasibility of conducting a full-scale randomised clinical trial (RCT), and the credibility and acceptability of the foot exercise plus education intervention.","['individuals with PHP', 'Twenty participants with PHP']","['foot exercise plus education', 'Foot exercise plus education versus wait and see', 'IFM training', 'physiotherapist and receive detailed education on self-management strategies as well as a progressive exercise program for the IFMs', 'foot exercise plus education, or (ii) brief advice']","['treatment effects, which will consist of pain, physical function, physical activity level, pain self-efficacy, perceived treatment effect, magnetic resonance and ultrasound image measurement of IFM morphology, ultrasound imaging measurement of plantar fascia thickness, IFM motor performance, foot posture, foot mobility, ankle dorsiflexion range of motion, toe flexor and plantar flexor strength/endurance', 'feasibility of conducting a full-scale randomised clinical trial (RCT), and the credibility and acceptability of the foot exercise plus education intervention']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231786', 'cui_str': 'Plantar heel pain'}]","[{'cui': 'C0454370', 'cui_str': 'Foot exercises'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0581753', 'cui_str': 'Muscle structure of foot'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0581753', 'cui_str': 'Muscle structure of foot'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C1286219', 'cui_str': 'Mobility of foot'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0454370', 'cui_str': 'Foot exercises'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",20.0,0.0820667,"Primary outcomes will be the feasibility of conducting a full-scale randomised clinical trial (RCT), and the credibility and acceptability of the foot exercise plus education intervention.","[{'ForeName': 'Melinda M', 'Initials': 'MM', 'LastName': 'Franettovich Smith', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, 4072, Australia. melinda.smith@uq.edu.au.'}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Collins', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, 4072, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Mellor', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, 4072, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Grimaldi', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, 4072, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Elliott', 'Affiliation': 'Faculty of Medicine and Health and The Kolling Research Institute, The University of Sydney, Sydney, New South Wales, 2006, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hoggarth', 'Affiliation': 'Department of Physical Therapy and Human Movement Sciences, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Weber Ii', 'Affiliation': 'Systems Neuroscience and Pain Lab, Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California, USA.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Vicenzino', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, 4072, Australia.'}]",Journal of foot and ankle research,['10.1186/s13047-020-00384-1']
66,32384914,"Propofol versus placebo (with rescue with ketamine) before less invasive surfactant administration: study protocol for a multicenter, double-blind, placebo controlled trial (PROLISA).","BACKGROUND


One major limitation for less invasive surfactant administration (LISA) is the difficulty in providing sedation before this procedure and the competitive risk of respiratory depression versus avoidance of intubation for most sedative or analgesic drugs used in this context. The objective of this study is to compare the need for mechanical ventilation within 72 h of life following premedication with propofol, versus placebo (rescue with ketamine), for the LISA procedure in preterm neonates born before 32 weeks gestational age (wGA).
METHODS


ProLISA is a phase III, non-inferiority, multicenter, double blind, randomized, placebo controlled trial designed according to the SPIRIT Statement. Neonates born before 32 wGA in 12 geographically dispersed Neonatal Intensive Care Units in France needing surfactant will be included from September 2019 to September 2022. A sample of 542 patients is needed. The neonate is randomized to the intervention (propofol) or control placebo group. Open label rescue treatment with ketamine is possible in both groups if FANS (Faceless Acute Neonatal pain Scale) is ≥6. To guide drug administration, FANS is scored before attempting laryngoscopy. Once an adequate score has been obtained, LISA is performed according to a standardized protocol. The primary outcome is the need for mechanical ventilation within 72 h of life. Secondary outcomes are tolerance of the procedure, pain evaluation, hemodynamic and neurologic parameters after the intervention, morbidities before discharge and neurodevelopmental assessment at 2 years of age.
DISCUSSION


This paper describes the first multicenter, double-blind, randomized, placebo-controlled trial on this topic and will provide crucial information to support implementation of the LISA procedure.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT04016246. Registered 06 June 2019, N°EUDRACT: 2018-002876-41.",2020,Open label rescue treatment with ketamine is possible in both groups if FANS (Faceless Acute Neonatal pain Scale) is ≥6.,"['Neonates born before 32 wGA in 12 geographically dispersed Neonatal Intensive Care Units in France needing surfactant will be included from September 2019 to September 2022', '542 patients', 'preterm neonates born before 32\u2009weeks gestational age (wGA']","['Propofol versus placebo', 'intervention (propofol) or control placebo', 'ketamine', 'invasive surfactant administration (LISA', 'propofol, versus placebo (rescue with ketamine', 'placebo']","['need for mechanical ventilation within 72\u2009h of life', 'tolerance of the procedure, pain evaluation, hemodynamic and neurologic parameters after the intervention, morbidities before discharge and neurodevelopmental assessment at 2\u2009years of age']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",,0.721645,Open label rescue treatment with ketamine is possible in both groups if FANS (Faceless Acute Neonatal pain Scale) is ≥6.,"[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Chevallier', 'Affiliation': 'UMR 5525 ThEMAS, CNRS, TIMC-IMAG, Grenoble Alps University, Grenoble, France. mchevallier3@chu-grenoble.fr.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Durrmeyer', 'Affiliation': 'Neonatal Intensive Care Unit, Centre Hospitalier Intercommunal de Créteil, Créteil, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ego', 'Affiliation': 'Neonatal Intensive Care Unit, Grenoble Alps University Hospital, Grenoble, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Debillon', 'Affiliation': 'UMR 5525 ThEMAS, CNRS, TIMC-IMAG, Grenoble Alps University, Grenoble, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC pediatrics,['10.1186/s12887-020-02112-x']
67,32384922,Logbooks alone are not enough: initial experience with implementing a logbook for medical students in a clinical internship in gynecology and obstetrics.,"BACKGROUND


Logbooks are being increasingly widely used as a means of improving medical education and further training. They will in all probability continue to be mandatory in the Practical Year (PJ) in Germany even after the upcoming amendment of the Medical Licensing Regulations (ÄAppO). However, there are different approaches to their design and use, and these are also currently undergoing considerable change. This study for the first time examines and discusses the influence of logbooks on students' evaluation of a gynecology internship.
METHODS


The study was based on a well-established two-part 1-week internship course, with initially unstructured morning classes on wards and duty areas, along with precisely planned afternoon classes with skills training by peer teachers and seminars supervised by duty-exempted physicians. The postgraduate lecturers were prepared for the introduction of the logbook in a special course, and the aim was to optimize morning classes by introducing learning objectives adapted to the respective locations. The effects over 38 weeks of practical training were examined in evaluations by 235 prospectively group-randomized students with and without logbooks (n = 166 and n = 66, respectively; three datasets were not evaluable).
RESULTS


In the cohort comparison, the logbook group responded significantly more positively toward the internship at the start of the course (P = 0.046). In the final evaluation, however, medical supervision during the entire internship was rated significantly more poorly (P = 0.007). The logbook cohort also considered that guidance based on learning objectives was significantly worse, as was the extent to which wards and duty areas were prepared for the students (P = 0.001 and P = 0.029).
CONCLUSIONS


Introducing a logbook to optimize clinical teaching in internships may raise expectations that cannot always be met. In addition to adapting the learning objectives to a general framework that is less favorable in comparison with the Practical Year, the least that is required appears to be simultaneous and continuous mentoring of the lecturers, as well as an increase in staffing resources.",2020,"In the final evaluation, however, medical supervision during the entire internship was rated significantly more poorly (P = 0.007).","['235 prospectively group-randomized students with and without logbooks (n\u2009=\u2009166 and n\u2009=\u200966, respectively; three datasets were not evaluable']",['skills training by peer teachers and seminars supervised by duty-exempted physicians'],[],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}]","[{'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]",[],,0.0224506,"In the final evaluation, however, medical supervision during the entire internship was rated significantly more poorly (P = 0.007).","[{'ForeName': 'Sebastian M', 'Initials': 'SM', 'LastName': 'Jud', 'Affiliation': 'Department of Gynecology, Erlangen University Hospital, Universitätsstrasse 21-23, 91054, Erlangen, Germany. Sebastian.jud@uk-erlangen.de.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Cupisti', 'Affiliation': 'Department of Gynecology, Erlangen University Hospital, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Frobenius', 'Affiliation': 'Department of Gynecology, Erlangen University Hospital, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}, {'ForeName': 'Sigrid', 'Initials': 'S', 'LastName': 'Benn', 'Affiliation': 'Department of Gynecology, Erlangen University Hospital, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Winkler', 'Affiliation': 'Department of Gynecology, Erlangen University Hospital, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Antoniadis', 'Affiliation': 'Department of Gynecology, Erlangen University Hospital, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}, {'ForeName': 'Matthias W', 'Initials': 'MW', 'LastName': 'Beckmann', 'Affiliation': 'Department of Gynecology, Erlangen University Hospital, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Heindl', 'Affiliation': 'Department of Gynecology, Erlangen University Hospital, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}]",European journal of medical research,['10.1186/s40001-020-00413-6']
68,32390729,The Achilles Tendon Response to a Bout of Running is not affected by Triceps Surae Stretch Training in Runners.,"An acute bout of distance running decreases Achilles tendon CSA. The purpose of this study was to examine if three-week stretch training of the Achilles tendon alters the Achilles tendon thinning response to running. Thirty-three recreational runners were divided into a control group (n = 17) and an intervention group (n = 16). The intervention included a three-week soleus stretch (knee flexed) and gastrocnemius stretch (knee extended). Three gastrocnemius stretches and three soleus stretches were performed each day, six days per week. Stretches were held for 30 s per repetition for a total duration of 180 s per leg per day. Achilles tendon CSA and range of motion measures were completed pre and post-run before and after the three-week stretching intervention. The runs prior to and following the three-week stretch training intervention both resulted in a 6% decrease in Achilles tendon CSA (p < 0.0001). There was no interaction across time between control and intervention groups in CSA (p = 0.446). Only the intervention group experienced a significant increase in dorsiflexion range of motion following the stretch training (p = 0.009). We therefore conclude that even when an increased dorsiflexion range of motion occurs, three weeks of triceps surae stretching does not alter the response of the Achilles tendon CSA.",2020,Only the intervention group experienced a significant increase in dorsiflexion range of motion following the stretch training (p = 0.009).,"['Thirty-three recreational runners', 'Runners']",['distance running'],"['dorsiflexion range of motion', 'Achilles tendon CSA', 'Achilles tendon CSA and range of motion measures']","[{'cui': 'C0450358', 'cui_str': '33'}]","[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0035953', 'cui_str': 'Running'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0210059,Only the intervention group experienced a significant increase in dorsiflexion range of motion following the stretch training (p = 0.009).,"[{'ForeName': 'Coulter D', 'Initials': 'CD', 'LastName': 'Neves', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Joshua K', 'Initials': 'JK', 'LastName': 'Sponbeck', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Katy Andrews', 'Initials': 'KA', 'LastName': 'Neves', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Ulrike H', 'Initials': 'UH', 'LastName': 'Mitchell', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Hunter', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Aaron Wayne', 'Initials': 'AW', 'LastName': 'Johnson', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}]",Journal of sports science & medicine,[]
69,32390731,Occlusion Training During Specific Futsal Training Improves Aspects of Physiological and Physical Performance.,"This study aimed to examine the effects of lower limb blood flow restriction (BFR) performed during 3-a-side futsal game training on aerobic and anaerobic performance of futsal players. Twelve male futsal players were randomized into two groups (n = 6); both groups performed ten sessions of the 3-a-side game every other day in half of a futsal court; but one group trained under BFR conditions. Pneumatic cuffs used for the BFR group were inflated to 110% leg systolic blood pressure and increased by 10% after each two completed sessions. Before and after the training sessions subjects completed a series of tests to assess aerobic and anaerobic performances along with changes in blood lactate and anabolic and catabolic hormones. All aerobic and anaerobic performance variables improved in both group after training, however improvements in mean power (12.2%, p = 0.03), run time to fatigue (TTF), (7.1%, p = 0.02) and running economy (RE), (-22.7%, p = 0.01) were significantly greater in the BFR group. There were also significant increases in growth hormone (p = 0.01), testosterone to cortisol ratio at first session (p = 0.01) and rate of lactate removal (p = 0.01) at last session in the BFR group compared to the non-BFR group. Small-sided game (SSG) training with the addition of BFR because of accumulated metabolites and hormonal changed leads to substantially greater increases in performance than SSGs training alone.",2020,"There were also significant increases in growth hormone (p = 0.01), testosterone to cortisol ratio at first session (p = 0.01) and rate of lactate removal (p = 0.01) at last session in the BFR group compared to the non-BFR group.","['futsal players', 'Twelve male futsal players']","['Occlusion Training During Specific Futsal Training', 'lower limb blood flow restriction (BFR) performed during 3-a-side futsal game training', 'Small-sided game']","['mean power', 'All aerobic and anaerobic performance variables', 'growth hormone', 'blood lactate and anabolic and catabolic hormones', 'Physiological and Physical Performance', 'run time to fatigue (TTF', 'rate of lactate removal', 'running economy (RE', 'leg systolic blood pressure', 'testosterone to cortisol ratio']","[{'cui': 'C1532535', 'cui_str': 'Indoor soccer'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1532535', 'cui_str': 'Indoor soccer'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0002845', 'cui_str': 'Anabolic steroid'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",12.0,0.0159885,"There were also significant increases in growth hormone (p = 0.01), testosterone to cortisol ratio at first session (p = 0.01) and rate of lactate removal (p = 0.01) at last session in the BFR group compared to the non-BFR group.","[{'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Amani-Shalamzari', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sarikhani', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Paton', 'Affiliation': 'Faculty of Health and Sport Science, the Eastern Institute of Technology, Napier, New Zealand.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rajabi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Bayati', 'Affiliation': 'Department of Exercise Physiology, Sports Medicine Research Center, Sport Sciences Research Institute, Tehran, Iran.'}, {'ForeName': 'Pantelis Theodoros', 'Initials': 'PT', 'LastName': 'Nikolaidis', 'Affiliation': 'Exercise Physiology Laboratory, Nikaia, Greece.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Knechtle', 'Affiliation': 'Medbase St. Gallen Am Vadianplatz, St. Gallen, Switzerland.'}]",Journal of sports science & medicine,[]
70,32390736,Acute Effects of Dynamic Stretching Followed by Vibration Foam Rolling on Sports Performance of Badminton Athletes.,"Dynamic stretching (DS) is performed to increase sports performance and is also used primarily for transiently increasing range of motion (ROM). Recently, vibration foam rolling (VFR) has emerged. Its underlying concept is that it combines foam rolling techniques with local vibration to improve ROM and muscular activation concurrently. This crossover study investigated the effects of DS or DS followed by VFR (DS + VFR) during warm-ups on flexibility, muscle stiffness, power, and agility of the lower limbs in badminton athletes. Forty badminton players performed DS or DS + VFR as warm-up exercises on two occasions in a randomized order. The target muscle groups were the bilateral shoulder, anterior and posterior thigh, posterior calf, and lower back. Main outcome measures: The primary outcome was knee range of motion (ROM), and the secondary outcomes were muscle stiffness, lower limb power (countermovement jump [CMJ]), and agility. Results indicated that the protocols improved performance. DS increased knee flexion ROM (% change = 1.92, ES = 0.3, p = 0.033), CMJ height (% change = 5.04, ES = 0.2, p = 0.004), and agility (% change = -4.97, ES = 0.4, p < 0.001) but increased quadriceps muscle stiffness (% change = 3.74, ES = 0.3, p = 0.001) and increased gastrocnemius muscle stiffness (% change = 10.39, ES = 0.5, p = 0.001). DS + VFR increased knee extension ROM (% change =2.87, ES = 0.4, p = 0.003), reduced quadriceps muscle stiffness (% change = -2.79, ES = 0.3, p = 0.017), CMJ height (% change = 2.41, ES = 0.1, p = 0.037), and agility (% change = -4.74, ES = 0.2, p < 0.001). DS + VFR was not significantly superior to DS, except for muscle stiffness reduction. Taken together, we suggest that practitioners consider DS as a first line of warm-up exercise to increase ROM, CMJ height, and agility in athletes. Moreover, the addition of VFR to DS results in a large reduction of muscle stiffness, potentially reducing the risk of sports injury. Athletes, coaches and athletic professionals may consider them when selecting effective warm-up practices to augment athletic performance.",2020,"DS + VFR increased knee extension ROM (% change =2.87, ES = 0.4, p = 0.003), reduced quadriceps muscle stiffness (% change = -2.79, ES = 0.3, p = 0.017), CMJ height (% change = 2.41, ES = 0.1, p = 0.037), and agility (% change = -4.74, ES = 0.2, p < 0.001).","['badminton athletes', 'Sports Performance of Badminton Athletes']","['Dynamic Stretching Followed by Vibration Foam Rolling', 'DS or DS followed by VFR (DS + VFR', 'DS + VFR', 'Dynamic stretching (DS']","['reduced quadriceps muscle stiffness', 'quadriceps muscle stiffness', 'performance', 'flexibility, muscle stiffness, power, and agility of the lower limbs', 'CMJ height', 'gastrocnemius muscle stiffness', 'DS or DS + VFR', 'knee extension ROM', 'DS increased knee flexion ROM', 'DS + VFR', 'knee range of motion (ROM), and the secondary outcomes were muscle stiffness, lower limb power (countermovement jump [CMJ]), and agility', 'ROM, CMJ height, and agility in athletes']","[{'cui': 'C0004678', 'cui_str': 'Badminton'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0991510', 'cui_str': 'Foam'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]",,0.0380452,"DS + VFR increased knee extension ROM (% change =2.87, ES = 0.4, p = 0.003), reduced quadriceps muscle stiffness (% change = -2.79, ES = 0.3, p = 0.017), CMJ height (% change = 2.41, ES = 0.1, p = 0.037), and agility (% change = -4.74, ES = 0.2, p < 0.001).","[{'ForeName': 'Wei-Cheng', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Department of Sports Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}, {'ForeName': 'Chia-Lun', 'Initials': 'CL', 'LastName': 'Lee', 'Affiliation': 'Center for Physical and Health Education, National Sun Yat-sen University, Kaohsiung 804, Taiwan.'}, {'ForeName': 'Nai-Jen', 'Initials': 'NJ', 'LastName': 'Chang', 'Affiliation': 'Department of Sports Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}]",Journal of sports science & medicine,[]
71,32390905,Insensitivity to Success and Failure: An Experimental Study of Performance-Based Feedback in Depression.,"Objective


This experimental study set out to examine the effects of performance feedback (success or failure) on depressed emotions and self-serving attribution bias in inpatients suffering from major depressive disorder (MDD).
Methods


The study was based on a 2 × 2 experimental design in which 71 MDD patients and 59 healthy controls participated. Both groups (MDD and controls) were randomly assigned to two conditions: success or failure in the performance feedback. A section of Raven's Standard Progressive Matrices (SPM) was used as a bogus test of the participants' reasoning abilities, and the Core Depressive Factor of the Zung Self-Rating Depression Scale was used to measure changes in depressed emotion in the subjects following the performance feedback. Participants then rated the accuracy of the SPM as a measure of their reasoning capacity.
Results


The levels of depressed emotions in patients with MDD did not differ significantly under the two feedback conditions. In contrast, depressed emotion levels increased significantly in healthy individuals in response to failure feedback but did not change in response to success feedback. With regard to the ratings of SPM accuracy, there was no significant difference across the two feedback conditions for depressed patients; however, the accuracy ratings were higher in the success condition than in the failure condition for the controls.
Conclusion


Individuals with MDD exhibit blunted emotional reactivity when experiencing new positive or negative social stimuli, supporting the theory of Emotion Context Insensitivity. In addition, self-serving attribution bias does not occur in MDD, which is consistent with the theory of learned helplessness in depression.",2020,"With regard to the ratings of SPM accuracy, there was no significant difference across the two feedback conditions for depressed patients; however, the accuracy ratings were higher in the success condition than in the failure condition for the controls.
","['inpatients suffering from major depressive disorder (MDD', '71 MDD patients and 59 healthy controls participated']",['performance feedback (success or failure'],"['SPM accuracy', 'accuracy ratings', 'depressed emotion levels', 'Insensitivity to Success and Failure', 'levels of depressed emotions']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",71.0,0.0255518,"With regard to the ratings of SPM accuracy, there was no significant difference across the two feedback conditions for depressed patients; however, the accuracy ratings were higher in the success condition than in the failure condition for the controls.
","[{'ForeName': 'Huiyuan', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'Medical Psychological Center, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Che', 'Affiliation': 'Medical Psychological Center, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Dailin', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Medical Psychological Center, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yinxia', 'Initials': 'Y', 'LastName': 'Chai', 'Affiliation': 'Medical Psychological Center, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Xingwei', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Medical Psychological Center, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Taisheng', 'Initials': 'T', 'LastName': 'Cai', 'Affiliation': 'Medical Psychological Center, The Second Xiangya Hospital, Central South University, Changsha, China.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00670']
72,32390910,Longitudinal Effects of Mediums of Word Explanation on L2 Vocabulary Learning Strategies Among Chinese Grade-7 Students.,"This longitudinal study investigated how different mediums of word explanation affected the use of English vocabulary strategies among Chinese Grade-7 students. 170 students were tested on their English receptive vocabulary size and vocabulary strategy application before and after an 8.33-month intervention. Students were divided into three experimental groups and one control group. The three experimental groups were provided with learning materials that explained the target vocabulary in three mediums, respectively: English-only, English-and-Chinese, and Chinese-only. Results showed that, after the intervention, receptive vocabulary size did not have any direct significant impact on vocabulary strategy development, whereas mediums of word explanation materials impacted students' application of vocabulary learning strategies (VLS) in different ways. Our findings showed that the English-only mediums significantly enhanced students' use of metacognition, cognition, and memorization strategies, but decreased social strategy development. Chinese-only mediums significantly facilitated cognition and memorization strategy development. Implications for L2 vocabulary education are discussed.",2020,"Results showed that, after the intervention, receptive vocabulary size did not have any direct significant impact on vocabulary strategy development, whereas mediums of word explanation materials impacted students' application of vocabulary learning strategies (VLS) in different ways.","['Chinese Grade-7 students', '170 students', 'Chinese Grade-7 Students']","['Mediums of Word Explanation on L2 Vocabulary Learning Strategies', 'learning materials that explained the target vocabulary in three mediums, respectively: English-only, English-and-Chinese, and Chinese-only']","[""students' use of metacognition, cognition, and memorization strategies""]","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517599', 'cui_str': '170'}]","[{'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0589513', 'cui_str': 'Metacognition'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",170.0,0.0119818,"Results showed that, after the intervention, receptive vocabulary size did not have any direct significant impact on vocabulary strategy development, whereas mediums of word explanation materials impacted students' application of vocabulary learning strategies (VLS) in different ways.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Social and Behavioural Sciences, City University of Hong Kong, Kowloon, Hong Kong.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'School of Economics and Management, China University of Petroleum, Qingdao, China.'}, {'ForeName': 'Sammy Xiao-Ying', 'Initials': 'SX', 'LastName': 'Wu', 'Affiliation': 'Department of Special Education and Counselling, The Education University of Hong Kong, Tai Po, Hong Kong.'}, {'ForeName': 'Wei-Yang', 'Initials': 'WY', 'LastName': 'Dong', 'Affiliation': 'Department of Asian Policy Studies, The Education University of Hong Kong, Tai Po, Hong Kong.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Chinese Language Studies, The Education University of Hong Kong, Tai Po, Hong Kong.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00702']
73,32392019,Financial Toxicity After Acute Respiratory Distress Syndrome: A National Qualitative Cohort Study.,"OBJECTIVES


The financial burdens and subsequent related distress of medical care, referred to as financial toxicity, may limit access to beneficial treatments. However, financial toxicity after acute care is less described-and may be an important but underexplored mechanism preventing full recovery after critical illnesses such as acute respiratory distress syndrome. We sought to identify the mechanisms by which financial toxicity manifested in patients with acute respiratory distress syndrome, protective factors against such toxicity, and the consequences of financial toxicity to survivors' lives following acute respiratory distress syndrome.
DESIGN


We conducted semistructured interviews following patients' hospitalization and during recovery as an ancillary study to a multicenter randomized clinical trial in acute respiratory distress syndrome. Patients were 9-16 months post randomization at the time of interview.
SETTING AND PARTICIPANTS


The Reevaluation Of Systemic Early Neuromuscular Blockade trial examined the use of early neuromuscular blockade in mechanically ventilated patients with moderate/severe acute respiratory distress syndrome. We recruited consecutive surviving patients who were English speaking, consented to follow-up, and were randomized between December 11, 2017, and May 4, 2018 (n = 79) from 29 U.S. sites.
MEASUREMENTS AND MAIN RESULTS


We asked about patients' perceptions of financial burden(s) that they associated with their acute respiratory distress syndrome hospitalization. Forty-six of 79 eligible acute respiratory distress syndrome survivors (58%) participated (from 22 sites); their median age was 56 (interquartile range 47-62). Thirty-one of 46 reported at least one acute respiratory distress syndrome-related financial impact. Financial toxicity manifested via medical bills, changes in insurance coverage, and loss of employment income. Respondents reported not working prior to acute respiratory distress syndrome, using Medicaid or Medicare, or, conversely, generous work benefits as factors which may have limited financial burdens. Patients reported multiple consequences of acute respiratory distress syndrome-related financial toxicity, including harms to their mental and physical health, increased reliance on others, and specific material hardships.
CONCLUSIONS


Financial toxicity related to critical illness is common and may limit patients' emotional, physical, and social recovery after acute respiratory distress syndrome hospitalization for at least a year.",2020,"Patients reported multiple consequences of acute respiratory distress syndrome-related financial toxicity, including harms to their mental and physical health, increased reliance on others, and specific material hardships.
","['patients with acute respiratory distress syndrome', 'acute respiratory distress syndrome', 'consecutive surviving patients who were English speaking, consented to follow-up, and were randomized between December 11, 2017, and May 4, 2018 (n = 79) from 29 U.S. sites', 'Forty-six of 79 eligible acute respiratory distress syndrome survivors (58%) participated (from 22 sites); their median age was 56 (interquartile range 47-62', 'mechanically ventilated patients with moderate/severe acute respiratory distress syndrome', 'Thirty-one of 46 reported at least one acute respiratory distress syndrome-related financial impact', 'After Acute Respiratory Distress Syndrome']",[],"['Financial toxicity manifested via medical bills, changes in insurance coverage, and loss of employment income', 'acute respiratory distress syndrome hospitalization', 'financial toxicity', 'Financial Toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",[],"[{'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0004895', 'cui_str': 'Beak'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0376629', 'cui_str': 'Insurance Status'}, {'cui': 'C0425083', 'cui_str': 'Loss of job'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.13736,"Patients reported multiple consequences of acute respiratory distress syndrome-related financial toxicity, including harms to their mental and physical health, increased reliance on others, and specific material hardships.
","[{'ForeName': 'Katrina E', 'Initials': 'KE', 'LastName': 'Hauschildt', 'Affiliation': 'Department of Sociology, College of Literature, Science, and Arts, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Seigworth', 'Affiliation': 'Veterans Affairs Center for Clinical Management Research, HSR&D Center of Innovation, Ann Arbor, MI.'}, {'ForeName': 'Lee A', 'Initials': 'LA', 'LastName': 'Kamphuis', 'Affiliation': 'Veterans Affairs Center for Clinical Management Research, HSR&D Center of Innovation, Ann Arbor, MI.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Hough', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Moss', 'Affiliation': 'Department of Medicine, Division of Pulmonary Sciences and Critical Care Medicine, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'McPeake', 'Affiliation': 'NHS Greater Glasgow and Clyde, Glasgow Royal Infirmary, Glasgow, United Kingdom.'}, {'ForeName': 'Theodore J', 'Initials': 'TJ', 'LastName': 'Iwashyna', 'Affiliation': 'Institute for Social Research, University of Michigan, Ann Arbor, MI.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004378']
74,32365097,"A phase 2, double-blind, multicenter, randomized, placebo-controlled, dose‑ranging study of the efficacy and safety of Astodrimer Gel for the treatment of bacterial vaginosis.","BACKGROUND


Astodrimer Gel contains a novel dendrimer intended to treat and prevent bacterial vaginosis. We assessed the efficacy and safety of Astodrimer Gel for treatment of bacterial vaginosis.
METHODS


132 women with bacterial vaginosis were randomized 1:1:1:1 to Astodrimer 0.5% (N = 34), 1% (N = 33), or 3% (N = 32) Gel or hydroxyethyl cellulose placebo gel (N = 33) at a dose of 5 g vaginally once daily for 7 days at 6 centers in the United States. The primary endpoint was clinical cure (no bacterial vaginosis vaginal discharge and no more than one of 1) vaginal pH ≥4.5; 2) ≥20% clue cells; or 3) positive whiff test) at study days 21-30. Secondary analyses included clinical cure at study days 9-12, patient-reported symptoms, acceptability and adverse events.
RESULTS


The Astodrimer 1% Gel dose was superior to placebo for the primary and selected secondary efficacy measures in the modified intent-to-treat population. Clinical cure rates at day 9-12 were superior to placebo for the Astodrimer 3%, 1% and 0.5% Gel groups (62.5% [15/24; P = .002], 74.1% [20/27; P < .001], and 55.2% [16/29; P = .001], respectively, vs. 22.2% [6/27]). At day 21-30, clinical cure rates were 46.2% (12/26) for the 1% dose vs. 11.5% for placebo (3/26; P = .006). A greater proportion of patients reported absence of vaginal discharge and vaginal odor at day 9-12 and day 21-30 for Astodrimer Gel groups compared with placebo. Adverse events considered potentially treatment-related occurred in only 25% of Astodrimer Gel-treated patients vs. 22% of placebo patients.
CONCLUSION


Astodrimer Gel once daily for 7 days was superior to placebo for treatment of bacterial vaginosis and was well-tolerated. The 1% dose consistently showed the strongest efficacy across endpoints. These results support a role for Astodrimer Gel, 1%, as an effective treatment for bacterial vaginosis.",2020,"Clinical cure rates at day 9-12 were superior to placebo for the Astodrimer 3%, 1% and 0.5% Gel groups (62.5% [15/24; P = .002], 74.1% [20/27; P < .001], and 55.2% [16/29; P = .001], respectively, vs. 22.2% [6/27]).","['bacterial vaginosis', '132 women with bacterial vaginosis']","['Gel or hydroxyethyl cellulose placebo gel', 'Astodrimer Gel', 'placebo']","['symptoms, acceptability and adverse events', 'efficacy and safety', 'clinical cure', 'Clinical cure rates', 'clinical cure rates', 'vaginal discharge and vaginal odor', 'clinical cure (no bacterial vaginosis vaginal discharge and no more than one of 1) vaginal pH ≥4.5']","[{'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0063131', 'cui_str': 'hydroxyethyl cellulose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0227791', 'cui_str': 'Vaginal discharge'}, {'cui': 'C0235678', 'cui_str': 'Vaginal odor'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}]",132.0,0.559696,"Clinical cure rates at day 9-12 were superior to placebo for the Astodrimer 3%, 1% and 0.5% Gel groups (62.5% [15/24; P = .002], 74.1% [20/27; P < .001], and 55.2% [16/29; P = .001], respectively, vs. 22.2% [6/27]).","[{'ForeName': 'Arthur S', 'Initials': 'AS', 'LastName': 'Waldbaum', 'Affiliation': ""Downtown Women's Health Care, Denver, CO, United States of America.""}, {'ForeName': 'Jane R', 'Initials': 'JR', 'LastName': 'Schwebke', 'Affiliation': 'Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, AL, United States of America.'}, {'ForeName': 'Jeremy R A', 'Initials': 'JRA', 'LastName': 'Paull', 'Affiliation': 'Starpharma Pty Ltd, Melbourne, VIC, Australia.'}, {'ForeName': 'Clare F', 'Initials': 'CF', 'LastName': 'Price', 'Affiliation': 'Starpharma Pty Ltd, Melbourne, VIC, Australia.'}, {'ForeName': 'Stephanie R', 'Initials': 'SR', 'LastName': 'Edmondson', 'Affiliation': 'Starpharma Pty Ltd, Melbourne, VIC, Australia.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Castellarnau', 'Affiliation': 'Starpharma Pty Ltd, Melbourne, VIC, Australia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'McCloud', 'Affiliation': 'McCloud Consulting Group, Sydney, NSW, Australia.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Kinghorn', 'Affiliation': 'Royal Hallamshire and Sheffield Teaching Hospitals, Sheffield, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0232394']
75,32365109,The influence of an induced negative emotional state on autobiographical memory coherence.,"Individuals who experience difficulty constructing coherent narratives about significant personal experiences generally report less psychological well-being and more depressive symptoms. It remains, however, unclear whether a negative emotional state, one of the core symptoms of depression, causes this impairment in autobiographical memory coherence. The current study aimed to examine the causal relation between mood and memory coherence by means of a mood induction paradigm. A group of 165 students were randomly allocated to one of three mood groups: negative, positive, and neutral. We hypothesized that memory coherence would decrease following a negative mood induction. In addition, working memory capacity was expected to mediate the association between mood and memory coherence. Contrary to predictions, memory coherence increased following a negative mood induction. This increase was likewise observed in the positive mood group, though memory coherence remained consistent in the neutral mood group. This effect of mood on memory coherence was solely observed in female participants and not in the small male subsample. Results provided no support for the hypothesis that working memory capacity functioned as an underlying mechanism. Different theoretical explanations are discussed.",2020,"This increase was likewise observed in the positive mood group, though memory coherence remained consistent in the neutral mood group.","['A group of 165 students', 'female participants and not in the small male subsample']",[],"['memory coherence', 'autobiographical memory coherence']","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],"[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}]",165.0,0.0311399,"This increase was likewise observed in the positive mood group, though memory coherence remained consistent in the neutral mood group.","[{'ForeName': 'Elien', 'Initials': 'E', 'LastName': 'Vanderveren', 'Affiliation': 'Center for the Psychology of Learning and Experimental Psychopathology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Loes', 'Initials': 'L', 'LastName': 'Aerts', 'Affiliation': 'Undergraduate students clinical and health psychology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Rousseaux', 'Affiliation': 'Undergraduate students clinical and health psychology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bijttebier', 'Affiliation': 'School Psychology and Development in Context, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Hermans', 'Affiliation': 'Center for the Psychology of Learning and Experimental Psychopathology, KU Leuven, Leuven, Belgium.'}]",PloS one,['10.1371/journal.pone.0232495']
76,32360392,A randomized controlled trial of transcranial direct-current stimulation and cognitive training in children with fetal alcohol spectrum disorder.,"BACKGROUND


This study was a randomized double-blind sham-controlled trial examining the effects of transcranial direct current stimulation (tDCS) augmented cognitive training (CT) in children with Fetal Alcohol Spectrum Disorders (FASD). Prenatal alcohol exposure has profound detrimental effects on brain development and individuals with FASD commonly present with deficits in executive functions including attention and working memory. The most commonly studied treatment for executive deficits is CT, which involves repeated drilling of exercises targeting the impaired functions. As currently implemented, CT requires many hours and the observed effect sizes are moderate. Neuromodulation via tDCS can enhance brain plasticity and prior studies demonstrate that combining tDCS with CT improves efficacy and functional outcomes. TDCS-augmented CT has not yet been tested in FASD, a condition in which there are known abnormalities in neuroplasticity and few interventions.
METHODS


This study examined the feasibility and efficacy of this approach in 44 children with FASD. Participants were randomized to receive five sessions of CT with either active or sham tDCS targeting the dorsolateral prefrontal cortex, a region of the brain that is heavily involved in executive functioning.
RESULTS


The intervention was feasible and well-tolerated in children with FASD. The tDCS group showed nominally significant improvement in attention on a continuous performance test compared to sham (p = .043). Group differences were observed at the third, fourth and fifth treatment sessions. There was no effect of tDCS on working memory (p = .911). Further, we found no group differences on a trail making task (p = .659) or on the verbal fluency test (p = .826). In the active tDCS group, a significant correlation was observed between improvement in attention scores and decrease in parent-reported attention deficits (p = .010).
CONCLUSIONS


These results demonstrate that tDCS-augmented CT is well tolerated in children with FASD and potentially offers benefits over and above CT alone.",2020,The tDCS group showed nominally significant improvement in attention on a continuous performance test compared to sham (p=.043).,"['children with fetal alcohol spectrum disorder', 'children with Fetal Alcohol Spectrum Disorders (FASD', 'children with FASD', '44 children with FASD']","['CT with either active or sham tDCS', 'transcranial direct current stimulation (tDCS) augmented cognitive training (CT', 'transcranial direct-current stimulation and cognitive training', 'tDCS', 'tDCS-augmented CT', 'CT', 'TDCS-augmented CT']","['feasibility and efficacy', 'trail making task', 'attention scores and decrease in parent-reported attention deficits', 'attention on a continuous performance test']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015923', 'cui_str': 'Fetal alcohol syndrome'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",44.0,0.0938664,The tDCS group showed nominally significant improvement in attention on a continuous performance test compared to sham (p=.043).,"[{'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Boroda', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Krueger', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Bansal', 'Affiliation': 'University of Maryland, USA.'}, {'ForeName': 'Mariah J', 'Initials': 'MJ', 'LastName': 'Schumacher', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Abhrajeet V', 'Initials': 'AV', 'LastName': 'Roy', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Boys', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Kelvin O', 'Initials': 'KO', 'LastName': 'Lim', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Wozniak', 'Affiliation': 'University of Minnesota, Twin Cities, USA. Electronic address: jwozniak@umn.edu.'}]",Brain stimulation,['10.1016/j.brs.2020.04.015']
77,32360399,Effect of different exercise training intensities on musculoskeletal and neuropathic pain in inactive individuals with type 2 diabetes - Preliminary randomised controlled trial.,"AIMS


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


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


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


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


ACTRN12615000475549.",2020,"Compared to CON, reduction in musculoskeletal pain intensity was significantly greater for C-HIIT (MD -5.4, 95% CI [","['inactive individuals with type 2 diabetes', 'Thirty-two inactive adults with T2D (59% male, mean age 58.7±9.1yrs, median HbA 1c  7.8', 'People with type 2 diabetes (T2D', 'Inactive Individuals with Type 2 Diabetes']","['usual care (CON), supervised combined aerobic and resistance moderate-intensity continuous training (C-MICT), or supervised combined high-intensity interval training (C-HIIT', 'CON', 'Different Exercise Training Intensities']","['modified Nordic Musculoskeletal Questionnaire and the Neuropathy Total Symptom Score-6 respectively', 'sensory function', 'Adverse events', 'Musculoskeletal and Neuropathic Pain', 'musculoskeletal pain intensity', 'neuropathy symptoms', 'adverse events', 'pain pressure thresholds', 'musculoskeletal and neuropathic pain', 'musculoskeletal pain']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",32.0,0.143575,"Compared to CON, reduction in musculoskeletal pain intensity was significantly greater for C-HIIT (MD -5.4, 95% CI [","[{'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Cox', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Trishan', 'Initials': 'T', 'LastName': 'Gajanand', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Nicola W', 'Initials': 'NW', 'LastName': 'Burton', 'Affiliation': 'School of Applied Psychology, Griffith University, Mt Gravatt, Queensland, Australia.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Coombes', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Brooke K', 'Initials': 'BK', 'LastName': 'Coombes', 'Affiliation': 'School of Allied Health Sciences, Griffith University, Nathan, Queensland, Australia. Electronic address: b.coombes@griffith.edu.au.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108168']
78,32369480,Effect of short-term prednisone on beta-cell function in subjects with type 2 diabetes mellitus and healthy subjects.,"OBJECTIVE


For those with type 2 diabetes mellitus (T2DM), impact of short-term high-dose glucocorticoid exposure on beta-cell function is unknown. This study aims to compare the impact on beta-cell function and insulin resistance of prednisone 40 mg between adults with newly diagnosed T2DM and healthy adults.
METHODS


Five adults with T2DM and five healthy adults, all between 18-50 years, were enrolled. T2DM diagnosis was less than one year prior, HbA1c<75 mmol/mol (9.0%), with metformin treatment only. Pre- and post-therapy testing included 75-g oral glucose tolerance, plasma glucose, C-peptide, and insulin. Intervention therapy was prednisone 40mg daily for 3 days.
RESULTS


Upon therapy completion, HOMA-IR did not increase or differ between groups. Percentile difference for HOMA-%B and insulinogenic index in those with T2DM was significantly lower statistically (50.4% and 69.2% respectively) compared to healthy subjects (19% and 32.2%).
CONCLUSIONS


Contrary to the assumption that insulin resistance is the main driver of glucocorticoid-induced hyperglycemia, results indicate that decreased beta-cell insulin secretion is the more likely cause in those with T2DM. This is evidenced by significant drops in C-peptide AUC and HOMA-%B and increased glucose AUC in T2DM group only. These results may be caused by increased beta-cell fragility along with reduced recovery ability after glucocorticoid exposure. ClinicalTrials.gov NCT03661684.",2020,This is evidenced by significant drops in C-peptide AUC and HOMA-%B and increased glucose AUC in T2DM group only.,"['Five adults with T2DM and five healthy adults, all between 18-50 years, were enrolled', 'subjects with type 2 diabetes mellitus and healthy subjects', 'adults with newly diagnosed T2DM and healthy adults']","['prednisone', 'short-term prednisone', 'metformin']","['HOMA-%B and insulinogenic index', 'T2DM diagnosis', 'beta-cell fragility', '75-g oral glucose tolerance, plasma glucose, C-peptide, and insulin', 'HOMA-IR', 'beta-cell function']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0302113', 'cui_str': 'Fragility'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",5.0,0.0451943,This is evidenced by significant drops in C-peptide AUC and HOMA-%B and increased glucose AUC in T2DM group only.,"[{'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Shah', 'Affiliation': 'John H. Stroger Jr. Hospital of Cook County, Chicago, Illinois, United States of America.'}, {'ForeName': 'May M', 'Initials': 'MM', 'LastName': 'Adel', 'Affiliation': 'John H. Stroger Jr. Hospital of Cook County, Chicago, Illinois, United States of America.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Tahsin', 'Affiliation': 'John H. Stroger Jr. Hospital of Cook County, Chicago, Illinois, United States of America.'}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Guerra', 'Affiliation': 'John H. Stroger Jr. Hospital of Cook County, Chicago, Illinois, United States of America.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Fogelfeld', 'Affiliation': 'John H. Stroger Jr. Hospital of Cook County, Chicago, Illinois, United States of America.'}]",PloS one,['10.1371/journal.pone.0231190']
79,32372046,The Influence of Listening to Music on Adults with Left-behind Experience Revealed by EEG-based Connectivity.,"The human brain has a close relationship with music. Music-induced structural and functional brain changes have been demonstrated in the healthy adult. In the present study, adults with left-behind experience (ALB) were divided into two groups. The experimental group (ALB-E) took part in the music therapy experiment with three stages, including before listening to music (pre-stage), initially listening to music (mid-stage) and after listening to music (post-stage). The control group (ALB-C) did not participate in music therapy. Scalp resting-state EEGs of ALB were recorded during the three stages. We found no significant frequency change in the ALB-C group. In the ALB-E group, only the theta power spectrum was significantly different at all stages. The topographical distributions of the theta power spectrum represented change in trends from the frontal regions to the occipital regions. The result of Granger causal analysis (GCA), based on theta frequency, showed a stronger information flow from the middle frontal gyrus to the middle temporal gyrus (MFG → MTG) in the left hemisphere at the pre-stage compared to the post-stage. Additionally, the experimental group showed a weaker information flow from inferior gyrus to superior temporal gyrus (IFG → STG) in the right hemisphere at post-test stage compared to the ALB-C group. Our results demonstrate that listening to music can play a positive role on improving negative feelings for individuals with left behind experience.",2020,"Additionally, the experimental group showed a weaker information flow from inferior gyrus to superior temporal gyrus (IFG → STG) in the right hemisphere at post-test stage compared to the ALB-C group.","['Adults with Left-behind Experience Revealed by EEG-based Connectivity', 'adults with left-behind experience (ALB', 'healthy adult']",['Listening to Music'],"['Scalp resting-state EEGs of ALB', 'negative feelings', 'weaker information flow from inferior gyrus to superior temporal gyrus (IFG\u2009→\u2009STG']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0152309', 'cui_str': 'Structure of superior temporal gyrus'}]",,0.025094,"Additionally, the experimental group showed a weaker information flow from inferior gyrus to superior temporal gyrus (IFG → STG) in the right hemisphere at post-test stage compared to the ALB-C group.","[{'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Bio-information College, ChongQing University of Posts and Telecommunications, ChongQing, 400065, China. tiany20032003@163.com.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Bio-information College, ChongQing University of Posts and Telecommunications, ChongQing, 400065, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Bio-information College, ChongQing University of Posts and Telecommunications, ChongQing, 400065, China.'}, {'ForeName': 'Sifan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Sichuan Heguang Clinical Psychology Institute, ChengDu, 610074, China.'}]",Scientific reports,['10.1038/s41598-020-64381-x']
80,32374787,Anodal transcranial direct current stimulation reduces collinear lateral inhibition in normal peripheral vision.,"Collinear flanking stimuli can reduce the detectability of a Gabor target presented in peripheral vision. This phenomenon is called collinear lateral inhibition and it may contribute to crowding in peripheral vision. Perceptual learning can reduce collinear lateral inhibition in peripheral vision, however intensive training is required. Our aim was to assess whether modulation of collinear lateral inhibition can be achieved within a short time-frame using a single 20-minute session of primary visual cortex anodal transcranial direct current stimulation (a-tDCS). Thirteen observers with normal vision performed a 2AFC contrast detection task with collinear flankers positioned at a distance of 2λ from the target (lateral inhibition) or 6λ (control condition). The stimuli were presented 6° to the left of a central cross and fixation was monitored with an infra-red eye tracker. Participants each completed two randomly sequenced, single-masked stimulation sessions; real anodal tDCS and sham tDCS. For the 2λ separation condition, a-tDCS induced a significant reduction in detection threshold (reduced lateral inhibition). Sham stimulation had no effect. No effects of a-tDCS were observed for the 6λ separation condition. This result lays the foundation for future work investigating whether a-tDCS may be useful as a visual rehabilitation tool for individuals with central vision loss who are reliant on peripheral vision.",2020,"For the 2λ separation condition, a-tDCS induced a significant reduction in detection threshold (reduced lateral inhibition).","['individuals with central vision loss who are reliant on peripheral vision', 'normal peripheral vision']","['single-masked stimulation sessions; real anodal tDCS and sham tDCS', 'Perceptual learning', 'Anodal transcranial direct current stimulation']",['detection threshold (reduced lateral inhibition'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0152191', 'cui_str': 'Central scotoma'}, {'cui': 'C0234628', 'cui_str': 'Peripheral vision'}, {'cui': 'C0278208', 'cui_str': 'Normal peripheral vision'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",13.0,0.0643383,"For the 2λ separation condition, a-tDCS induced a significant reduction in detection threshold (reduced lateral inhibition).","[{'ForeName': 'Rajkumar Nallour', 'Initials': 'RN', 'LastName': 'Raveendran', 'Affiliation': 'Envision Research Institute, Wichita, Kansas, United States of America.'}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Tsang', 'Affiliation': 'School of Optometry & Vision Science, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Dilraj', 'Initials': 'D', 'LastName': 'Tiwana', 'Affiliation': 'School of Optometry & Vision Science, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chow', 'Affiliation': 'School of Optometry & Vision Science, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Thompson', 'Affiliation': 'School of Optometry & Vision Science, University of Waterloo, Waterloo, Ontario, Canada.'}]",PloS one,['10.1371/journal.pone.0232276']
81,32375735,Primary surgery versus no surgery in synchronous metastatic breast cancer: patient-reported quality-of-life outcomes of the prospective randomized multicenter ABCSG-28 Posytive Trial.,"BACKGROUND


The ABCSG-28 trial compared primary surgery followed by systemic therapy versus primary systemic therapy without surgery in patients with de novo stage IV BC. The present report describes QoL results of this trial.
METHODS


Ninety patients with primary operable MBC were randomised to surgery of the primary tumor followed by systemic therapy or to primary systemic therapy without surgery. QoL analyses covering the results at baseline, 6,12,18 and 24 months follow up of 79 (88%) patients, was assessed with the EORTC QLQ-C30 and QLQ-BR23 questionnaires.
RESULTS


There were no statistically significant differences in any of the scales of the QLQ-C30 and QLQ-BR23 questionnaires between the two groups over the time. Baseline global health status and physical functioning were predictors for OS (patients with a higher score lived longer (p=0.0250, p=0.0225; p=0.0355, p=0.0355)). Global health status, social functioning scale, breast symptoms and future perspective were predictors for longer TTPd (p=0.0244; p=0.0140, p=0.020; p=0.0438, p=0.0123). Patients in both arms reported significant improvement on the emotional functioning scale. Cognitive functioning decreased over time in both groups. Younger women had clinically relevant better physical and sexual functioning scores (p=0.039 and 0.024).
CONCLUSION


Primary surgery does not improve nor alter QoL of patients with de novo stage IV BC. Global health status and physical functioning were predictors for OS and could be use as additional marker for prediction of OS and TTTd in patients with de novo stage IV BC.
TRIAL REGISTRATION


The trial is registered on clinicaltrial.gov (NCT01015625, date of registration:18/11/2009).",2020,There were no statistically significant differences in any of the scales of the QLQ-C30 and QLQ-BR23 questionnaires between the two groups over the time.,"['Younger women', 'synchronous metastatic breast cancer', 'patients with de novo stage IV BC', 'Ninety patients with primary operable MBC']","['primary surgery followed by systemic therapy versus primary systemic therapy without surgery', 'systemic therapy or to primary systemic therapy without surgery', 'Primary surgery versus no surgery']","['Baseline global health status and physical functioning', 'Global health status and physical functioning', 'QLQ-C30 and QLQ-BR23 questionnaires', 'physical and sexual functioning scores', 'Global health status, social functioning scale, breast symptoms', 'EORTC QLQ-C30 and QLQ-BR23 questionnaires', 'emotional functioning scale', 'Cognitive functioning']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0065839', 'cui_str': 'Carbendazim'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2585826', 'cui_str': 'Social functioning scale'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",90.0,0.199077,There were no statistically significant differences in any of the scales of the QLQ-C30 and QLQ-BR23 questionnaires between the two groups over the time.,"[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Bjelic-Radisic', 'Affiliation': 'Breast Unit, University Hospital Wuppertal, Heusnerstraße 40, 42283, Wuppertal, Germany. vesna.bjelic-radisic@helios-gesundheit.de.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Fitzal', 'Affiliation': 'Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Knauer', 'Affiliation': 'Breast Unit, Kantonsspital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Steger', 'Affiliation': 'Department of Internal Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Egle', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical University Innsbruck, Inssbruck, Austria.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Department of Internal Medicine III with Hematology, Medical Oncology, Hemostaseology, Infectious Disease, Rheumatology, Oncologic Center, Laboratory for Immunological and Molecular cancer Reseasrch, Paracelsus Medical University Salzburg, Salzburg, Austria.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schrenk', 'Affiliation': 'Department of Surgery, Medical University Linz, Linz, Austria.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Balic', 'Affiliation': 'Division of Oncology, Department of Internal Medicine and Comprehensive Cancer Center, Medical University Graz, Graz, Austria.'}, {'ForeName': 'Ch', 'Initials': 'C', 'LastName': 'Singer', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical University Vienna, Vienna, Austria.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Exner', 'Affiliation': 'Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Soelkner', 'Affiliation': 'Statistics Department, Austrian Breast and Colorectal Cancer Study Group (ABCSG), Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC cancer,['10.1186/s12885-020-06894-2']
82,32376724,"Apatinib plus camrelizumab (anti-PD1 therapy, SHR-1210) for advanced osteosarcoma (APFAO) progressing after chemotherapy: a single-arm, open-label, phase 2 trial.","BACKGROUND


Results of our previous study showed high objective response but short-term activity of apatinib in advanced osteosarcoma. We aimed to investigate the activity of apatinib in combination with camrelizumab in patients with inoperable high-grade osteosarcoma progressing after chemotherapy.
METHODS


This open-label, phase 2 trial was conducted at Peking University People's Hospital. We enrolled patients with advanced osteosarcoma progressed after chemotherapy. Patients received 500 mg apatinib orally once daily plus 200 mg camrelizumab by intravenous infusion every 2 weeks until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS) and clinical benefit rate at 6 months, which were based on RECIST V.1.1.
RESULTS


43 patients were enrolled between January 25 and September 4, 2018. With median follow-up time of 48.3 (Q1, Q3, 30.6, 66.6) weeks, 13 (30.23%, 95% CI 17.2%, 40.1%) of 43 patients were progression free at 6 months and the 6-month PFS rate was 50.9% (95% CI 34.6%, 65.0%). Until final follow-up, the objective response rate was 20.9% (9/43) and two patients with durable disease control were observed. Patients with programmed cell death 1 ligand-1 (PD-L1) tumor proportion score ≥5% and pulmonary metastases tended to have a longer PFS in comparison to the others (p=0.004 and 0.017, respectively). Toxic effects led to dose reductions, or interruptions, or both in 24 (55.8%) of 43 patients and permanent discontinuation in 4 (9.3%) patients. There were no treatment-related deaths.
CONCLUSIONS


Although the combination of apatinib and camrelizumab seemed to prolong PFS in comparison to single agent apatinib in treating advanced osteosarcoma, it did not reach the prespecified target of 6-month PFS of 60% or greater. Overexpression of PD-L1 and the presence of pulmonary metastases only were associated with longer PFS.
TRIAL REGISTRATION NUMBER


NCT03359018.",2020,"Toxic effects led to dose reductions, or interruptions, or both in 24 (55.8%) of 43 patients and permanent discontinuation in 4 (9.3%) patients.","['Patients with programmed cell death 1 ligand-1 (PD-L1', ""Peking University People's Hospital"", '43 patients were enrolled between January 25 and September 4, 2018', 'enrolled patients with advanced osteosarcoma progressed after chemotherapy', 'patients with inoperable high-grade osteosarcoma progressing after chemotherapy', 'advanced osteosarcoma (APFAO) progressing after chemotherapy']","['Apatinib plus camrelizumab (anti-PD1 therapy, SHR-1210', '500\u2009mg apatinib orally once daily plus 200\u2009mg camrelizumab', 'camrelizumab']","['Toxic effects', 'progression free', '6-month PFS rate', 'Overexpression of PD-L1 and the presence of pulmonary metastases', 'objective response rate', 'progression-free survival (PFS) and clinical benefit rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0029463', 'cui_str': 'Osteosarcoma'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C2346836', 'cui_str': 'apatinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4682408', 'cui_str': 'camrelizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4552121', 'cui_str': 'SHR-1210'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0153676', 'cui_str': 'Secondary malignant neoplasm of lung'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",43.0,0.208514,"Toxic effects led to dose reductions, or interruptions, or both in 24 (55.8%) of 43 patients and permanent discontinuation in 4 (9.3%) patients.","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China bonetumor@163.com.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Surgical Oncology, Peking University Shougang Hospital, Beijing, China.'}, {'ForeName': 'Kuisheng', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Bingxin', 'Initials': 'B', 'LastName': 'Zheng', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Ren', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Taiqiang', 'Initials': 'T', 'LastName': 'Yan', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Rongli', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Kunkun', 'Initials': 'K', 'LastName': 'Sun', 'Affiliation': ""Pathology Department, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Danhua', 'Initials': 'D', 'LastName': 'Shen', 'Affiliation': ""Pathology Department, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Radiology Department & Nuclear Medicine Department, Peking University People's Hospital, Beijing, China.""}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-000798']
83,32383366,Effects of  Lactobacillus pentosus  in Children with Allergen-Sensitized Atopic Dermatitis.,"BACKGROUND


Recent studies have shown that oral administration of probiotics may improve the immune imbalance caused by dysbiosis of the gut microbiome in atopic dermatitis (AD). This study aimed to investigate the clinical and immunological effects of  Lactobacillus pentosus  in children with mild to moderate AD.
METHODS


Children aged 2-13 years with AD were randomized to receive either 1.0 × 10 10  colony-forming units of  L. pentosus  or placebo, daily, for 12 weeks. The clinical severity of AD and transepidermal water loss were evaluated. Blood eosinophil counts, serum total immunoglobulin E (IgE), and cytokine levels were measured. The diversity and composition of the gut microbiota were also analyzed.
RESULTS


Eighty-two children were recruited, and 41 were assigned to the probiotics intervention group. The mean scoring of atopic dermatitis (SCORAD) indices at baseline were 30.4 and 34.3 for the probiotics and placebo groups, respectively. At week 12, the mean indices were 23.6 and 23.1 for the probiotics and placebo groups, respectively. Clinical severity decreased significantly over time in both groups, with no significant difference between the two groups. In both groups, there were no significant differences in cytokine levels, microbial diversity, or the relative abundance of the gut microbiota at week 12 compared with the corresponding baseline values. The mean subjective scores of SCORAD indices after intervention for the probiotics group were significantly lower than those for the placebo group in IgE sensitized AD ( P  = 0.019).
CONCLUSION


Our results show improved symptoms in the probiotics and placebo groups, and we could not find additional effects of  L. pentosus  in AD. However, the mean subjective scores of SCORAD indices for the probiotics group are significantly improved compared with those for the placebo group in allergen-sensitized AD.",2020,"In both groups, there were no significant differences in cytokine levels, microbial diversity, or the relative abundance of the gut microbiota at week 12 compared with the corresponding baseline values.","['Children aged 2-13 years with AD', 'Eighty-two children', 'Children with Allergen-Sensitized Atopic Dermatitis', 'children with mild to moderate AD']","['1.0 × 10 10  colony-forming units of  L. pentosus  or placebo', 'probiotics intervention', 'placebo']","['clinical severity of AD and transepidermal water loss', 'mean subjective scores of SCORAD indices', 'diversity and composition of the gut microbiota', 'Blood eosinophil counts, serum total immunoglobulin E (IgE), and cytokine levels', 'cytokine levels, microbial diversity, or the relative abundance of the gut microbiota', 'Clinical severity', 'mean scoring of atopic dermatitis (SCORAD) indices']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0428539', 'cui_str': 'Total immunoglobulin measurement'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",82.0,0.112825,"In both groups, there were no significant differences in cytokine levels, microbial diversity, or the relative abundance of the gut microbiota at week 12 compared with the corresponding baseline values.","[{'ForeName': 'So Hyun', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Department of Pediatrics, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Wonsuck', 'Initials': 'W', 'LastName': 'Yoon', 'Affiliation': 'Allergy Immunology Center, Korea University, Seoul, Korea.'}, {'ForeName': 'So Young', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Research Division of Food Functionality, Korea Food Research Institute, Wanju, Korea.'}, {'ForeName': 'Hee Soon', 'Initials': 'HS', 'LastName': 'Shin', 'Affiliation': 'Research Division of Food Functionality, Korea Food Research Institute, Wanju, Korea.'}, {'ForeName': 'Mi Young', 'Initials': 'MY', 'LastName': 'Lim', 'Affiliation': 'Research Division of Food Functionality, Korea Food Research Institute, Wanju, Korea.'}, {'ForeName': 'Young Do', 'Initials': 'YD', 'LastName': 'Nam', 'Affiliation': 'Research Division of Food Functionality, Korea Food Research Institute, Wanju, Korea.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Yoo', 'Affiliation': 'Department of Pediatrics, Korea University College of Medicine, Seoul, Korea.'}]",Journal of Korean medical science,['10.3346/jkms.2020.35.e128']
84,32380954,Correlation and variation of cuff inflating volumes and pressures in different adult models of laryngeal mask: a prospective randomized trial.,"BACKGROUND


Hyperinflation of laryngeal mask cuffs may carry the risk of airway complications. The manufacturer recommends inflating cuff until the intracuff pressure reaches 60 cmH 2 O, or inflate with the volume of air to not exceed the maximum recommended volume. We prospectively assessed the correlation of cuff inflating volumes and pressures, and the appropriated the cuff inflating volumes to generate an intracuff pressure of 60 cmH 2 O in the adult laryngeal masks from different manufacturers.
METHODS


Two groups of 80 patients requiring laryngeal mask size 3 and 4 during general anesthesia were randomized into 4 subgroups for each size of the laryngeal mask: Soft Seal® (Portex®), AuraOnce™ (Ambu®), LMA-Classic™ (Teleflex®) and LMA-ProSeal™ (Teleflex®). After insertion, the cuff was inflated with 5-ml increments of air up to the maximum recommended volume. After each 5-ml intracuff pressure was measured, the volume of air that generated the intracuff pressure of 60 cmH 2 O was recorded.
RESULTS


Mean (SD) volume of air required to achieve the intracuff pressure of 60 cmH 2 O in Soft Seal®, AuraOnce™, LMA-Classic™, LMA-ProSeal™ laryngeal mask size 3 were 11.80(1.88), 9.20(1.88), 8.95(1.50) and 13.50(2.48) ml, respectively, and these volumes in laryngeal mask size 4 were 14.45(4.12), 12.55(1.85), 11.30(1.95) and 18.20(3.47) ml, respectively. The maximum recommended volume resulted in high intracuff pressures (> 60 cmH 2 O) in all laryngeal mask types and sizes studied.
CONCLUSION


Pressure-volume curves of adult laryngeal masks are all in sigmoidal shape. Cuff designs and materials can effect pressure and volume correlation. Approximately half of the maximum recommended volume is required to achieve the intracuff pressure of 60 cmH 2 O except LMA-ProSeal™ which required two-thirds of the maximum recommended volume.
TRIAL REGISTRATION


Thai Clinical Trials Registry, TCTR20150602001, May 28, 2015.",2020,"The maximum recommended volume resulted in high intracuff pressures (> 60 cmH 2 O) in all laryngeal mask types and sizes studied.
CONCLUSION


Pressure-volume curves of adult laryngeal masks are all in sigmoidal shape.","['different adult models of laryngeal mask', 'Two groups of 80 patients requiring laryngeal mask size 3 and 4 during general anesthesia']","['laryngeal mask: Soft Seal® (Portex®), AuraOnce™ (Ambu®), LMA-Classic™ (Teleflex®) and LMA-ProSeal™ (Teleflex®']",['Mean (SD) volume of air required to achieve the intracuff pressure'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0439658', 'cui_str': 'Classic'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",,0.0560544,"The maximum recommended volume resulted in high intracuff pressures (> 60 cmH 2 O) in all laryngeal mask types and sizes studied.
CONCLUSION


Pressure-volume curves of adult laryngeal masks are all in sigmoidal shape.","[{'ForeName': 'Narut', 'Initials': 'N', 'LastName': 'Ruananukun', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Rajchathewi, Bangkok, 10400, Thailand. aek_narut@hotmail.com.'}, {'ForeName': 'Jittiya', 'Initials': 'J', 'LastName': 'Watcharotayangul', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Rajchathewi, Bangkok, 10400, Thailand.'}, {'ForeName': 'Suchaya', 'Initials': 'S', 'LastName': 'Jeeranukosol', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Rajchathewi, Bangkok, 10400, Thailand.'}, {'ForeName': 'Rojnarin', 'Initials': 'R', 'LastName': 'Komonhirun', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Rajchathewi, Bangkok, 10400, Thailand.'}]",BMC anesthesiology,['10.1186/s12871-020-01028-4']
85,32380972,"SAFE: an eHealth intervention for women experiencing intimate partner violence - study protocol for a randomized controlled trial, process evaluation and open feasibility study.","BACKGROUND


Intimate partner violence (IPV) affects almost one in three women worldwide. However, disclosing violence or seeking help is difficult for affected women. eHealth may represent an effective alternative to the standard support offers, which often require face-to-face interaction, because of easy accessibility and possibility of anonymous usage. In the Netherlands we are developing SAFE, an eHealth intervention for female victims of IPV, which will be evaluated in a randomized controlled trial and a process evaluation, followed by an open feasibility study to assess real-world user data.
METHODS/DESIGN


The randomized controlled trial is a two-arm parallel design comparing an intervention arm and a control group. The groups both have access to eHealth but differ in the offer of interactive features compared to static information. Both groups complete questionnaires at three or four time points (baseline, three months, six months, 12 months) with self-efficacy at 6 months as the primary outcome, measured with the General Self-Efficacy (GSE) scale. The process evaluation consists of quantitative data (from the website and from web evaluation questionnaires) and qualitative data (from interviews) on how the website was used and the users' experiences.
DISCUSSION


eHealth has the potential to reach a large number of women who experience IPV. The internet-based design can lower access barriers and encourage help-seeking behavior ultimately reducing the lag time between subjective awareness and protective action.
TRIAL REGISTRATION


Trial registered on 15 August 2017 at the Netherlands Trial Register NL7108 (NTR7313).",2020,"The internet-based design can lower access barriers and encourage help-seeking behavior ultimately reducing the lag time between subjective awareness and protective action.
","['women experiencing intimate partner violence', 'Trial registered on 15 August 2017 at the Netherlands Trial Register NL7108 (NTR7313']","['eHealth intervention', 'SAFE']",['General Self-Efficacy (GSE) scale'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.109392,"The internet-based design can lower access barriers and encourage help-seeking behavior ultimately reducing the lag time between subjective awareness and protective action.
","[{'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'van Gelder', 'Affiliation': 'Department of Gender in Primary and Transmural Care, Radboud University Medical Center, Postbus 9101, 6500 HB Nijmegen; Geert Grooteplein 21 - route 117, 6525 EZ, Nijmegen, the Netherlands. nicole.vangelder@radboudumc.nl.'}, {'ForeName': 'K A W L', 'Initials': 'KAWL', 'LastName': 'van Rosmalen-Nooijens', 'Affiliation': 'Department of Gender in Primary and Transmural Care, Radboud University Medical Center, Postbus 9101, 6500 HB Nijmegen; Geert Grooteplein 21 - route 117, 6525 EZ, Nijmegen, the Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'A Ligthart', 'Affiliation': 'Department of Gender in Primary and Transmural Care, Radboud University Medical Center, Postbus 9101, 6500 HB Nijmegen; Geert Grooteplein 21 - route 117, 6525 EZ, Nijmegen, the Netherlands.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Prins', 'Affiliation': 'Department of Gender in Primary and Transmural Care, Radboud University Medical Center, Postbus 9101, 6500 HB Nijmegen; Geert Grooteplein 21 - route 117, 6525 EZ, Nijmegen, the Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Oertelt-Prigione', 'Affiliation': 'Department of Gender in Primary and Transmural Care, Radboud University Medical Center, Postbus 9101, 6500 HB Nijmegen; Geert Grooteplein 21 - route 117, 6525 EZ, Nijmegen, the Netherlands.'}, {'ForeName': 'A L M', 'Initials': 'ALM', 'LastName': 'Lagro-Janssen', 'Affiliation': 'Department of Gender in Primary and Transmural Care, Radboud University Medical Center, Postbus 9101, 6500 HB Nijmegen; Geert Grooteplein 21 - route 117, 6525 EZ, Nijmegen, the Netherlands.'}]",BMC public health,['10.1186/s12889-020-08743-0']
86,32383748,Effect of Zinc Supplementation vs Placebo on Mortality Risk and HIV Disease Progression Among HIV-Positive Adults With Heavy Alcohol Use: A Randomized Clinical Trial.,"Importance


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


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


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


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


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


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


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


ClinicalTrials.gov Identifier: NCT01934803.",2020,"In the per-protocol analyses, zinc supplementation statistically significantly affected changes in the VACS Index score at 18 months (AMD, -7.49; 95% CI, -13.74 to -1.23; P = .02); however, the adherence rate to zinc supplementation was 51%.
","['participants recruited from 2013 to 2015', 'Participants were adults (aged 18-70 years) with documented HIV infection who were antiretroviral therapy-naive at baseline and had past 30-day heavy alcohol consumption', 'HIV-Positive Adults With Heavy Alcohol Use', 'Participants were recruited from HIV and addiction clinical and nonclinical care sites in St Petersburg, Russia', 'A total of 254 participants (184 men [72%]; mean [SD] age, 34 [6] years) were enrolled in the trial; 126', 'people with heavy alcohol use who are living with HIV/AIDS']","['Zinc supplementation', 'zinc supplementation', 'Zinc Supplementation vs Placebo', 'Intervention\n\n\nPharmacy-grade zinc gluconate supplementation', 'placebo']","['Mortality Risk and HIV Disease Progression', 'mortality risk', 'cardiovascular disease risk (Reynolds Risk Score', 'change in CD4 cell count', 'high CD4 cell counts', 'VACS Index score', 'changes in inflammatory or microbial translocation biomarkers', 'soluble CD14 level', 'mortality risk measured as a change in Veterans Aging Cohort Study (VACS', 'VACS Index scores range', 'interleukin-6 level', 'adherence rate to zinc supplementation', 'lipopolysaccharide binding protein level', 'mortality and risk of cardiovascular disease, reduces levels of inflammation and microbial translocation, and slows HIV disease progression', 'Index score', 'intestinal fatty acid binding protein level', 'heavy drinking', 'dimerized plasmin fragment D level', 'mortality risk, CD4 cell counts, cardiovascular disease risk, and levels of inflammation or microbial translocation', 'Reynolds Risk Score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0337950', 'cui_str': 'Site of care'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0149381', 'cui_str': 'Zinc Gluconate'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1141957', 'cui_str': 'HIV disease progression'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040715', 'cui_str': 'Chromosomal translocation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0065054', 'cui_str': 'lipopolysaccharide-binding protein'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0163314', 'cui_str': 'Intestinal Fatty Acid-Binding Protein'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0016016', 'cui_str': 'Plasmin'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}]",126.0,0.736847,"In the per-protocol analyses, zinc supplementation statistically significantly affected changes in the VACS Index score at 18 months (AMD, -7.49; 95% CI, -13.74 to -1.23; P = .02); however, the adherence rate to zinc supplementation was 51%.
","[{'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Freiberg', 'Affiliation': 'Vanderbilt Center for Clinical Cardiovascular Trials Evaluation (V-C3REATE), Cardiovascular Division, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Debbie M', 'Initials': 'DM', 'LastName': 'Cheng', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Gnatienko', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Blokhina', 'Affiliation': 'First Pavlov State Medical University of St Petersburg, St Petersburg, Russian Federation.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Coleman', 'Affiliation': 'Biostatistics and Epidemiology Data Analytics Center (BEDAC), Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Margaret F', 'Initials': 'MF', 'LastName': 'Doyle', 'Affiliation': 'Larner College of Medicine, Department of Pathology and Laboratory Medicine, The University of Vermont, Colchester.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Yaroslavtseva', 'Affiliation': 'First Pavlov State Medical University of St Petersburg, St Petersburg, Russian Federation.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Bridden', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Kaku', 'Initials': 'K', 'LastName': 'So-Armah', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Tracy', 'Affiliation': 'Larner College of Medicine, Department of Pathology and Laboratory Medicine, The University of Vermont, Colchester.'}, {'ForeName': 'Kendall', 'Initials': 'K', 'LastName': 'Bryant', 'Affiliation': 'HIV/AIDS Research, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Lioznov', 'Affiliation': 'First Pavlov State Medical University of St Petersburg, St Petersburg, Russian Federation.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Krupitsky', 'Affiliation': 'First Pavlov State Medical University of St Petersburg, St Petersburg, Russian Federation.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Samet', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Boston Medical Center, Boston, Massachusetts.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.4330']
87,32391156,Low-chloride- versus high-chloride-containing hypertonic solution for the treatment of subarachnoid hemorrhage-related complications: The ACETatE (A low ChloriE hyperTonic solution for brain Edema) randomized trial.,"Background


Recent reports have demonstrated that among patients with subarachnoid hemorrhage (SAH) treated with hypertonic NaCl, resultant hyperchloremia has been associated with the development of acute kidney injury (AKI). We report a trial comparing the effect of two hypertonic solutions with different chloride contents on the resultant serum chloride concentrations in SAH patients, with a primary outcome aimed at limiting chloride elevation.
Methods


A low ChloridE hyperTonic solution for brain Edema (ACETatE) trial is a single-center, double-blinded, double-dummy, randomized pilot trial comparing bolus infusions of 23.4% NaCl and 16.4% NaCl/Na-acetate for the treatment of cerebral edema in patients with SAH. Randomization occurred when patients developed hyperchloremia (serum Cl -  ≥ 109 mmol/L) and required hyperosmolar treatment.
Results


We enrolled 59 patients, of which 32 developed hyperchloremia and required hyperosmolar treatment. 15 patients were randomized to the 23.4% NaCl group, and 17 patients were randomized to the 16.4% NaCl/Na-acetate group. Although serum chloride levels increased similarly in both groups, the NaCl/Acetate group showed a significantly lower Cl -  load at the end of the study period (978mEq vs. 2,464mEq,  p  < 0.01). Secondary outcome analysis revealed a reduced rate of AKI in the Na-acetate group (53.3% in the NaCl group vs. 11.8% in the Na-acetate group,  p  = 0.01). Both solutions had similar effects on ICP reduction, but NaCl/Acetate treatment had a more prominent effect on immediate post-infusion Na +  concentrations (increase of 2.2 ± 2.8 vs. 1.4 ± 2.6, ( p  < 0.01)). Proximal tubule renal biomarkers differed in concentration between the two groups.
Conclusions


Our pilot trial showed the feasibility and safety of replacing 23.4% NaCl infusions with 16.4% NaCl/Na-acetate infusions to treat cerebral edema in patients with SAH. The degree of hyperchloremia was similar in the two groups. 16.4% NaCl/Na-acetate infusions led to lower Cl -  load and AKI rates than 23.4% NaCl infusions. Further multi-center studies are needed to corroborate these results.
Trial registration


clinicaltrials.gov # NCT03204955, registered on 6/28/2017.",2020,"Secondary outcome analysis revealed a reduced rate of AKI in the Na-acetate group (53.3% in the NaCl group vs. 11.8% in the Na-acetate group,  p  = 0.01).","['subarachnoid hemorrhage-related complications', 'We enrolled 59 patients, of which 32 developed hyperchloremia and required hyperosmolar treatment', 'SAH patients', '15 patients were randomized to the 23.4% NaCl group, and 17 patients', 'patients with SAH', 'patients with subarachnoid hemorrhage (SAH) treated with']","['hypertonic NaCl', 'low ChloridE hyperTonic solution', 'NaCl and 16.4% NaCl/Na-acetate', 'NaCl/Na-acetate group', 'NaCl infusions with 16.4% NaCl/Na-acetate infusions', 'Low-chloride- versus high-chloride-containing hypertonic solution', 'hypertonic solutions']","['degree of hyperchloremia', 'cerebral edema', 'ICP reduction', 'serum chloride levels', 'reduced rate of AKI', 'Cl -  load', 'feasibility and safety', 'immediate post-infusion Na +  concentrations', 'lower Cl -  load and AKI rates']","[{'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085679', 'cui_str': 'Hyperchloremia'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C1959973', 'cui_str': 'Percent sodium chloride'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0860861', 'cui_str': 'Cl- decreased'}, {'cui': 'C0020554', 'cui_str': 'Hypertonic solutions'}, {'cui': 'C1959973', 'cui_str': 'Percent sodium chloride'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085679', 'cui_str': 'Hyperchloremia'}, {'cui': 'C0006114', 'cui_str': 'Cerebral edema'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1317978', 'cui_str': 'Serum chloride measurement'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",59.0,0.317213,"Secondary outcome analysis revealed a reduced rate of AKI in the Na-acetate group (53.3% in the NaCl group vs. 11.8% in the Na-acetate group,  p  = 0.01).","[{'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Sadan', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Singbartl', 'Affiliation': '2Department of Critical Care Medicine, Mayo Clinic, 5777 E Mayo Blvd, Phoenix, AZ 85054 USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Kraft', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Joao McONeil', 'Initials': 'JM', 'LastName': 'Plancher', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Alexander C M', 'Initials': 'ACM', 'LastName': 'Greven', 'Affiliation': '3School of Medicine, Emory University, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Prem', 'Initials': 'P', 'LastName': 'Kandiah', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Cederic', 'Initials': 'C', 'LastName': 'Pimentel', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Hall', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Papangelou', 'Affiliation': '4Department of Anesthesiology, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Asbury', 'Affiliation': '5Department of Pharmacy, Emory University Hospital, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Hanfelt', 'Affiliation': '6Department of Biostatistics and Bioinformatics, Emory University, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Samuels', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}]",Journal of intensive care,['10.1186/s40560-020-00449-0']
88,32391158,Fear-avoidance beliefs are associated with exercise adherence: secondary analysis of a randomised controlled trial (RCT) among female healthcare workers with recurrent low back pain.,"Background


Exercise is recommended for the treatment and management of low back pain (LBP) and the prevention of chronicity. Exercise adherence has been only modest in intervention studies among people with musculoskeletal pain. Fear-avoidance beliefs (FABs) are known to affect exercise adherence. The purpose  was twofold: to examine which bio-psycho-social factors contributed to exercise adherence during a 6-month neuromuscular exercise intervention among female healthcare workers with recurrent LBP, and to investigate how exercising affects FABs at 6 and 12 months' follow-up.
Methods


Some 219 healthcare workers aged 30-55 years with mild-to-moderate re-current non-specific LBP were originally allocated into: 1) exercise, 2) counselling, 3) combined exercise and counselling, and 4) control groups. In the present secondary analysis, groups 1 and 3 (exercise only and exercise+counselling) were merged to be exercisers and groups 2 and 4 were merged to be non-exercisers. Baseline variables of the exercise compliers (≥24 times over 24 weeks;  n  = 58) were compared to those of the non-compliers (< 1 time/week, 0-23 times;  n  = 52). The effects of the exercise programme on FABs were analysed by a generalised linear mixed model according to the intention-to-treat principle (exercisers;  n  = 110 vs non-exercisers;  n  = 109) at three measurement points (baseline, 6, and 12 months). A per-protocol analysis compared the more exercised to the less exercised and non-exercisers.
Results


A low education level ( p  = 0.026), shift work ( p  = 0.023), low aerobic  (p  = 0.048) and musculoskeletal ( p  = 0.043) fitness, and high baseline physical activity-related FABs ( p  = 0.019) were related to low exercise adherence. The exercise programme reduced levels of both physical activity- and work-related FABs, and there was a dose response: FABs reduced more in persons who exercised ≥24 times compared to those who exercised 0-23 times.
Conclusion


Healthcare workers who had lower education and fitness levels, worked shifts, and had high physical activity-related FABs had a lower adherence to the 6-month neuromuscular exercise programme. Exercising with good adherence reduced levels of FABs, which have been shown to be linked with prolonged LBP. Motivational strategies should be targeted at persons with low education and fitness levels and high FABs in order to achieve better exercise adherence.",2020,"The exercise programme reduced levels of both physical activity- and work-related FABs, and there was a dose response: FABs reduced more in persons who exercised ≥24 times compared to those who exercised 0-23 times.
","['people with musculoskeletal pain', '219 healthcare workers aged 30-55\u2009years with mild-to-moderate re-current non-specific LBP', 'female healthcare workers with recurrent low back pain', 'female healthcare workers with recurrent LBP']","['neuromuscular exercise intervention', '\n\n\nExercise', 'exercise programme', 'exercise, 2) counselling, 3) combined exercise and counselling, and 4) control groups']","['low aerobic', 'high baseline physical activity-related FABs', 'FABs', 'musculoskeletal', 'levels of both physical activity- and work-related FABs', 'Fear-avoidance beliefs (FABs']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0751648', 'cui_str': 'Recurrent Low Back Pain'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043227', 'cui_str': 'Working'}]",219.0,0.0379503,"The exercise programme reduced levels of both physical activity- and work-related FABs, and there was a dose response: FABs reduced more in persons who exercised ≥24 times compared to those who exercised 0-23 times.
","[{'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Taulaniemi', 'Affiliation': '1UKK Institute for Health Promotion Research, Tampere, Finland.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Kankaanpää', 'Affiliation': '2Department of Physical and Rehabilitation Medicine, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Marjo', 'Initials': 'M', 'LastName': 'Rinne', 'Affiliation': '1UKK Institute for Health Promotion Research, Tampere, Finland.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Tokola', 'Affiliation': '1UKK Institute for Health Promotion Research, Tampere, Finland.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Parkkari', 'Affiliation': '1UKK Institute for Health Promotion Research, Tampere, Finland.'}, {'ForeName': 'Jaana H', 'Initials': 'JH', 'LastName': 'Suni', 'Affiliation': '1UKK Institute for Health Promotion Research, Tampere, Finland.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-020-00177-w']
89,32391167,"Body, Soul and Spirit, an adaptation of two evidence-based interventions to promote physical activity and healthy eating among adults in churches in Lagos Nigeria: a three-arm cluster randomized controlled pilot trial.","Background


Physical inactivity and unhealthy eating are two leading behavioral risk factors contributing to preventable non-communicable diseases (NCDs). Evidence-based interventions (EBI) using community-engaged approaches to address these risks abound in high-income countries. Comparatively, evidence of such interventions is sparse in low- and middle-income countries, where NCD mortality is greater. This paper describes the protocol for the development of the cultural adaptation and pilot testing of a combination of two EBI (i.e., Body and Soul and the Healthy Body Healthy Spirit), in church-based settings in Lagos, Nigeria. In addition, we describe the development of the inclusion of an additional component, i.e., faith-based text messages, into one of the treatment arms. Our objective is to assess the feasibility of developing and implementing the adapted interventions with the ultimate aim of developing a fully powered trial.
Methods


This pilot study will assess the design and implementation of a three-arm cluster-randomized pilot trial in 12 randomly selected Anglican churches (4 in each arm). First, we will design a cultural adaptation of the two EBI's to form a multifaceted combined intervention known as the  Body Soul and Spirit . The second treatment arm, i.e.,  Body Soul and Spirit Plus , will retain all the components of  Body Soul and Spirit  with the inclusion of faith-based text messages using mobile phones. Participants in the control arm will receive information leaflets designed to increase physical activity and healthy food consumption. The outcome measures include participant recruitment and retention, program participation and satisfaction, and data collection completion rates. The outcomes for the proposed definitive trial will be the number of servings of fruit and vegetables and minutes of moderate to vigorous physical activity per day will be assessed at baseline, 3 and 6-month follow-up. Implementation outcomes will be assessed using qualitative and quantitative methods.
Discussion


The study will enhance the understanding of how best to design and implement behavioral interventions in church-based settings using community-based participatory approaches. It will also inform the development of a definitive randomized controlled trial.
Trial registration


Pan African Clinical Trials Registry on 12th July 2018. PACTR201807136835945. Available at https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3481.",2020,Evidence-based interventions (EBI) using community-engaged approaches to address these risks abound in high-income countries.,"['Healthy Body Healthy Spirit), in church-based settings in Lagos, Nigeria', 'adults in churches in Lagos Nigeria', '12 randomly selected Anglican churches (4 in each arm']",['Body Soul and Spirit'],"['participant recruitment and retention, program participation and satisfaction, and data collection completion rates', 'physical activity and healthy food consumption']","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0301611', 'cui_str': 'Distilled spirits'}, {'cui': 'C0562324', 'cui_str': 'Church'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337726', 'cui_str': 'Anglican Church'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0301611', 'cui_str': 'Distilled spirits'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",12.0,0.111384,Evidence-based interventions (EBI) using community-engaged approaches to address these risks abound in high-income countries.,"[{'ForeName': 'Oluwakemi Ololade', 'Initials': 'OO', 'LastName': 'Odukoya', 'Affiliation': '1Department of Community Health and Primary Care, College of Medicine, University of Lagos, State, Lagos, Nigeria.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Manortey', 'Affiliation': 'ENSIGN School of Public Health, Kpong, Ghana.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Takemoto', 'Affiliation': '3Department of Family Medicine and Public Health, School of Medicine, UC San Diego, San Diego, CA USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Alder', 'Affiliation': 'ENSIGN School of Public Health, Kpong, Ghana.'}, {'ForeName': 'Kolawole S', 'Initials': 'KS', 'LastName': 'Okuyemi', 'Affiliation': '5Department of Family and Preventive Medicine, University of Utah School Of Medicine, Salt Lake City, UT USA.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00600-6']
90,32390133,Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis.,"BACKGROUND


Malnutrition is common in patients with chronic kidney disease (CKD) on dialysis. Oral protein-based nutritional supplements are often provided to patients whose oral intake is otherwise insufficient to meet their energy and protein needs. Evidence for the effectiveness of oral protein-based nutritional supplements in this population is limited.
OBJECTIVES


The aims of this review were to determine the benefits and harms of using oral protein-based nutritional supplements to improve the nutritional state of patients with CKD requiring dialysis.
SEARCH METHODS


We searched the Cochrane Kidney and Transplant Register of Studies up to 12 December 2019 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.
SELECTION CRITERIA


Randomised controlled trials (RCTs) of patients with CKD requiring dialysis that compared oral protein-based nutritional supplements to no oral protein-based nutritional supplements or placebo.
DATA COLLECTION AND ANALYSIS


Two authors independently assessed studies for eligibility, risk of bias, and extracted data from individual studies. Summary estimates of effect were obtained using a random-effects model, and results were expressed as risk ratios and their 95% confidence intervals (CI) for dichotomous outcomes, and mean difference and 95% CI for continuous outcomes.
MAIN RESULTS


Twenty-two studies (1278 participants) were included in this review. All participants were adults on maintenance dialysis of whom 79% were on haemodialysis (HD) and 21% peritoneal dialysis. The follow-up period ranged from one to 12 months. The majority of studies were at unclear risk of selection, performance, and reporting bias. The detection bias was high for self-reported outcomes. Oral protein-based nutritional supplements probably lead to a higher mean change in serum albumin compared to the control group (16 studies, 790 participants: MD 0.19 g/dL, 95% CI 0.05 to 0.33; moderate certainty evidence), although there was considerable heterogeneity in the combined analysis (I 2  = 84%). The increase was more evident in HD participants (10 studies, 526 participants: MD 0.28 g/dL, 95% CI 0.11 to 0.46; P = 0.001 for overall effect) and malnourished participants (8 studies, 405 participants: MD 0.31 g/dL, 95% CI 0.10 to 0.52, P = 0.003 for overall effect). Oral protein-based nutritional supplements also probably leads to a higher mean serum albumin at the end of the intervention (14 studies, 715 participants: MD 0.14 g/dL, 95% CI 0 to 0.27; moderate certainty evidence), however heterogeneity was again high (I 2  = 80%). Again the increase was more evident in HD participants (9 studies, 498 participants: MD 0.21 g/dL, 95% CI 0.03 to 0.38; P = 0.02 for overall effect) and malnourished participants (7 studies, 377 participants: MD 0.25 g/dL, 95% CI 0.02 to 0.47; P = 0.03 for overall effect). Compared to placebo or no supplement, low certainty evidence showed oral protein-based nutritional supplements may result in a higher serum prealbumin (4 studies, 225 participants: MD 2.81 mg/dL, 95% CI 2.19 to 3.43), and mid-arm muscle circumference (4 studies, 216 participants: MD 1.33 cm, 95% CI 0.24 to 2.43) at the end of the intervention. Compared to placebo or no supplement, oral protein-based nutritional supplements may make little or no difference to weight (8 studies, 365 participants: MD 2.83 kg, 95% CI -0.43 to 6.09; low certainty evidence), body mass index (9 studies, 368 participants: MD -0.04 kg/m 2 , 95% CI -0.74 to 0.66; moderate certainty evidence) and lean mass (5 studies, 189 participants: MD 1.27 kg, 95% CI -1.61 to 4.51; low certainty evidence). Due to very low quality of evidence, it is uncertain whether oral protein-based nutritional supplements affect triceps skinfold thickness, mid-arm circumference, C-reactive protein, Interleukin 6, serum potassium, or serum phosphate. There may be little or no difference in the risk of developing gastrointestinal intolerance between participants who received oral protein-based nutritional supplements compared with placebo or no supplement (6 studies, 426 participants: RR 2.81, 95% CI 0.58 to 13.65, low certainty evidence). It was not possible to draw conclusions about cost or quality of life, and deaths were not reported as a study outcome in any of the included studies.
AUTHORS' CONCLUSIONS


Overall, it is likely that oral protein-based nutritional supplements increase both mean change in serum albumin and serum albumin at end of intervention and may improve serum prealbumin and mid-arm muscle circumference. The improvement in serum albumin was more evident in haemodialysis and malnourished participants. However, it remains uncertain whether these results translate to improvement in nutritional status and clinically relevant outcomes such as death. Large well-designed RCTs in this population are required.",2020,"The increase was more evident in HD participants (10 studies, 526 participants: MD 0.28 g/dL, 95% CI 0.11 to 0.46; P = 0.001 for overall effect) and malnourished participants (8 studies, 405 participants: MD 0.31 g/dL, 95% CI 0.10 to 0.52, P = 0.003 for overall effect).","['patients with CKD requiring dialysis', 'Twenty-two studies (1278 participants', 'patients with CKD requiring dialysis that compared', '365 participants: MD 2.83 kg, 95% CI -0.43 to 6.09; low certainty evidence), body mass index (9 studies, 368 participants', 'people with chronic kidney disease requiring dialysis', 'All participants were adults on maintenance dialysis of whom 79% were on haemodialysis (HD) and 21% peritoneal dialysis', 'patients with chronic kidney disease (CKD) on dialysis']","['Oral protein-based nutritional supplements', 'placebo or no supplement, oral protein-based nutritional supplements', 'Oral protein-based supplements versus placebo', 'oral protein-based nutritional supplements', 'oral protein-based nutritional supplements to no oral protein-based nutritional supplements or placebo', 'placebo']","['serum albumin', 'moderate certainty evidence) and lean mass', 'serum prealbumin and mid-arm muscle circumference', 'cost or quality of life, and deaths', 'mean serum albumin', 'serum albumin and serum albumin', 'risk of developing gastrointestinal intolerance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0562347', 'cui_str': 'Mid arm muscle circumference'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}]",,0.257445,"The increase was more evident in HD participants (10 studies, 526 participants: MD 0.28 g/dL, 95% CI 0.11 to 0.46; P = 0.001 for overall effect) and malnourished participants (8 studies, 405 participants: MD 0.31 g/dL, 95% CI 0.10 to 0.52, P = 0.003 for overall effect).","[{'ForeName': 'Jia Yee', 'Initials': 'JY', 'LastName': 'Mah', 'Affiliation': 'Integrated Renal Service, Eastern Health, Box Hill, Australia.'}, {'ForeName': 'Suet Wan', 'Initials': 'SW', 'LastName': 'Choy', 'Affiliation': 'Integrated Renal Service, Eastern Health, Box Hill, Australia.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Roberts', 'Affiliation': 'Integrated Renal Service, Eastern Health, Box Hill, Australia.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Desai', 'Affiliation': 'Department of Dietetics/Renal, Eastern Health, Box Hill, Australia.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Corken', 'Affiliation': 'Department of Dietetics/Renal, Eastern Health, Box Hill, Australia.'}, {'ForeName': 'Stella M', 'Initials': 'SM', 'LastName': 'Gwini', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Clayton, Australia.'}, {'ForeName': 'Lawrence P', 'Initials': 'LP', 'LastName': 'McMahon', 'Affiliation': 'Integrated Renal Service, Eastern Health, Box Hill, Australia.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012616.pub2']
91,32402160,Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma.,"BACKGROUND


The combination of atezolizumab and bevacizumab showed encouraging antitumor activity and safety in a phase 1b trial involving patients with unresectable hepatocellular carcinoma.
METHODS


In a global, open-label, phase 3 trial, patients with unresectable hepatocellular carcinoma who had not previously received systemic treatment were randomly assigned in a 2:1 ratio to receive either atezolizumab plus bevacizumab or sorafenib until unacceptable toxic effects occurred or there was a loss of clinical benefit. The coprimary end points were overall survival and progression-free survival in the intention-to-treat population, as assessed at an independent review facility according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).
RESULTS


The intention-to-treat population included 336 patients in the atezolizumab-bevacizumab group and 165 patients in the sorafenib group. At the time of the primary analysis (August 29, 2019), the hazard ratio for death with atezolizumab-bevacizumab as compared with sorafenib was 0.58 (95% confidence interval [CI], 0.42 to 0.79; P<0.001). Overall survival at 12 months was 67.2% (95% CI, 61.3 to 73.1) with atezolizumab-bevacizumab and 54.6% (95% CI, 45.2 to 64.0) with sorafenib. Median progression-free survival was 6.8 months (95% CI, 5.7 to 8.3) and 4.3 months (95% CI, 4.0 to 5.6) in the respective groups (hazard ratio for disease progression or death, 0.59; 95% CI, 0.47 to 0.76; P<0.001). Grade 3 or 4 adverse events occurred in 56.5% of 329 patients who received at least one dose of atezolizumab-bevacizumab and in 55.1% of 156 patients who received at least one dose of sorafenib. Grade 3 or 4 hypertension occurred in 15.2% of patients in the atezolizumab-bevacizumab group; however, other high-grade toxic effects were infrequent.
CONCLUSIONS


In patients with unresectable hepatocellular carcinoma, atezolizumab combined with bevacizumab resulted in better overall and progression-free survival outcomes than sorafenib. (Funded by F. Hoffmann-La Roche/Genentech; ClinicalTrials.gov number, NCT03434379.).",2020,"Overall survival at 12 months was 67.2% (95% CI, 61.3 to 73.1) with atezolizumab-bevacizumab and 54.6% (95% CI, 45.2 to 64.0) with sorafenib.","['patients with unresectable hepatocellular carcinoma who had not previously received systemic treatment', 'group and 165 patients in the sorafenib group', 'Unresectable Hepatocellular Carcinoma', '336 patients in the', 'patients with unresectable hepatocellular carcinoma']","['sorafenib', 'atezolizumab and bevacizumab', 'Atezolizumab plus Bevacizumab', 'atezolizumab-bevacizumab', 'atezolizumab plus bevacizumab or sorafenib', 'bevacizumab']","['overall and progression-free survival outcomes', 'Median progression-free survival', 'Grade 3 or 4 hypertension', 'Grade 3 or 4 adverse events', 'Overall survival', 'antitumor activity and safety', 'grade toxic effects', 'overall survival and progression-free survival', 'hazard ratio for death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.465943,"Overall survival at 12 months was 67.2% (95% CI, 61.3 to 73.1) with atezolizumab-bevacizumab and 54.6% (95% CI, 45.2 to 64.0) with sorafenib.","[{'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Galle', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ducreux', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Tae-You', 'Initials': 'TY', 'LastName': 'Kim', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Valeriy', 'Initials': 'V', 'LastName': 'Breder', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Merle', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Ahmed O', 'Initials': 'AO', 'LastName': 'Kaseb', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Daneng', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Verret', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Derek-Zhen', 'Initials': 'DZ', 'LastName': 'Xu', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Sairy', 'Initials': 'S', 'LastName': 'Hernandez', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Sohail', 'Initials': 'S', 'LastName': 'Mulla', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Yulei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Ho Yeong', 'Initials': 'HY', 'LastName': 'Lim', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Andrew X', 'Initials': 'AX', 'LastName': 'Zhu', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Ann-Lii', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915745']
92,32402261,The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) Adapted as a School-Based Anxiety and Depression Prevention Program: An Initial Cluster Randomized Wait-List-Controlled Trial.,"Anxiety and depression are common debilitating conditions that show high comorbidity rates in adolescence. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A; Ehrenreich-May et al., 2018) is one of the few existing resources aimed at applying transdiagnostic treatment principles across the core dysfunctions implicated in the development of both anxiety and depression using a single protocol. This is the first known controlled study to examine the efficacy of the UP-A adapted as a nine-session universal preventive intervention program delivered in a school setting. A total of 151 students (mean age: 15.05) participated in this randomized wait-list-controlled trial conducted in Madrid, Spain. An unexpected decline in anxiety and depression levels from pre- to posttreatment and follow-up was found in both groups (p = .009, d = -0.22), and overall differences between conditions did not reach significance. Exploratory analyses of baseline emotional symptom severity as a potential predictor trended toward a significantly greater decrease in symptoms of depression for those with greater baseline emotional symptoms in the UP-A group compared to the wait-list-control group. Future trials with larger samples are justified to estimate the effect of the UP-A adapted as a selective prevention program for anxiety and depression.",2020,"An unexpected decline in anxiety and depression levels from pre- to posttreatment and follow-up was found in both groups (p = .009, d = -0.22), and overall differences between conditions did not reach significance.","['Emotional Disorders in Adolescents (UP-A) Adapted as a School-Based Anxiety and Depression Prevention Program', '151 students (mean age: 15.05) participated in this randomized wait-list-controlled trial conducted in Madrid, Spain']",[],"['symptoms of depression', 'anxiety and depression levels']","[{'cui': 'C0233459', 'cui_str': 'Emotional disorder'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}]",151.0,0.0310334,"An unexpected decline in anxiety and depression levels from pre- to posttreatment and follow-up was found in both groups (p = .009, d = -0.22), and overall differences between conditions did not reach significance.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'García-Escalera', 'Affiliation': 'Universidad Nacional de Educación a Distancia.'}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Valiente', 'Affiliation': 'Universidad Nacional de Educación a Distancia. Electronic address: rmvalien@psi.uned.es.'}, {'ForeName': 'Bonifacio', 'Initials': 'B', 'LastName': 'Sandín', 'Affiliation': 'Universidad Nacional de Educación a Distancia.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Ehrenreich-May', 'Affiliation': 'University of Miami.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Prieto', 'Affiliation': 'Universidad Nacional de Educación a Distancia.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Chorot', 'Affiliation': 'Universidad Nacional de Educación a Distancia.'}]",Behavior therapy,['10.1016/j.beth.2019.08.003']
93,32393732,"Longer term follow-up of the randomized phase III trial SWOG S0777: bortezomib, lenalidomide and dexamethasone vs. lenalidomide and dexamethasone in patients (Pts) with previously untreated multiple myeloma without an intent for immediate autologous stem cell transplant (ASCT).","SWOG S0777, a randomized phase III trial, compared bortezomib, lenalidomide and dexamethasone (VRd) with lenalidomide and dexamethasone (Rd). This updated analysis includes 460 patients evaluable for survival endpoints: 225 eligible and analyzable patients were randomized to Rd and 235 to VRd. The 6-month induction was six 28-day cycles of Rd and eight 21-day cycles of VRd followed by Rd maintenance for all patients. Median follow up is 84 months. Median PFS is 41 months for VRd and 29 months for Rd: stratified hazard ratio (96% Wald Confidence Interval) was 0.742 (0.594, 0.928) and one-sided stratified log-rank P-value 0.003. Median OS for VRd is still not reached with median OS for Rd being 69 months: stratified hazard ratio (96% Wald Confidence Interval) was 0.709 (0.543, 0.926) and stratified two-sided P-value was 0.0114. Both PFS and OS were improved with VRd versus Rd adjusting for age (P-values: 0.013 [PFS]; 0.033 [OS])). Median duration of Rd maintenance was 17.1 months. The addition of bortezomib to lenalidomide dexamethasone for induction therapy results in a statistically significant and clinically meaningful improvement in PFS as well as better OS. VRd continues to represent an appropriate standard of care irrespective of age.",2020,Both PFS and OS were improved with VRd versus Rd adjusting for age (P-values: 0.013 [PFS]; 0.033 [OS])).,"['460 patients evaluable for survival endpoints: 225 eligible and analyzable patients', 'patients (Pts) with previously untreated multiple myeloma without an intent for immediate autologous stem cell transplant (ASCT']","['bortezomib, lenalidomide and dexamethasone vs. lenalidomide and dexamethasone', 'bortezomib, lenalidomide and dexamethasone (VRd) with lenalidomide and dexamethasone (Rd', 'bortezomib to lenalidomide dexamethasone']","['Median PFS', 'Median OS for VRd', 'Median duration of Rd maintenance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",,0.128355,Both PFS and OS were improved with VRd versus Rd adjusting for age (P-values: 0.013 [PFS]; 0.033 [OS])).,"[{'ForeName': 'Brian G M', 'Initials': 'BGM', 'LastName': 'Durie', 'Affiliation': 'Cedars Sinai Cancer Center, Los Angeles, CA, USA. BDurie@myeloma.org.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Hoering', 'Affiliation': 'SWOG Statistical Center, Seattle, WA, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Sexton', 'Affiliation': 'SWOG Statistical Center, Seattle, WA, USA.'}, {'ForeName': 'Muneer H', 'Initials': 'MH', 'LastName': 'Abidi', 'Affiliation': 'Michigan State University/Spectrum Health Cancer Center, Grand Rapids, MI, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Epstein', 'Affiliation': 'Myeloma Institute, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'S Vincent', 'Initials': 'SV', 'LastName': 'Rajkumar', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Dispenzieri', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Kahanic', 'Affiliation': 'Sanford NCORP of the North Central Plains/ Siouxland Regional Cancer Center, Sioux City, IA, USA.'}, {'ForeName': 'Mohan C', 'Initials': 'MC', 'LastName': 'Thakuri', 'Affiliation': 'Cancer Care Western NC, Asheville, NC, USA.'}, {'ForeName': 'Frederic J', 'Initials': 'FJ', 'LastName': 'Reu', 'Affiliation': 'Department of Hematology and Medical Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reynolds', 'Affiliation': 'Michigan Cancer Research Consortium NCORP, St. Joseph Mercy Hospital, Ann Arbor, MI, USA.'}, {'ForeName': 'Robert Z', 'Initials': 'RZ', 'LastName': 'Orlowski', 'Affiliation': 'Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Barlogie', 'Affiliation': ''}]",Blood cancer journal,['10.1038/s41408-020-0311-8']
94,32393741,Randomized resonant metamaterials for single-sensor identification of elastic vibrations.,"Vibrations carry a wealth of useful physical information in various fields. Identifying the multi-source vibration information generally requires a large number of sensors and complex hardware. Compressive sensing has been shown to be able to bypass the traditional sensing requirements by encoding spatial physical fields, but how to encode vibration information remains unexplored. Here we propose a randomized resonant metamaterial with randomly coupled local resonators for single-sensor compressed identification of elastic vibrations. The disordered effective masses of local resonators lead to highly uncorrelated vibration transmissions, and the spatial vibration information can thus be physically encoded. We demonstrate that the spatial vibration information can be reconstructed via a compressive sensing framework, and this metamaterial can be reconfigured while maintaining desirable performance. This randomized resonant metamaterial presents a new perspective for single-sensor vibration sensing via vibration transmission encoding, and potentially offers an approach to simpler sensing devices for many other physical information.",2020,"This randomized resonant metamaterial presents a new perspective for single-sensor vibration sensing via vibration transmission encoding, and potentially offers an approach to simpler sensing devices for many other physical information.",[],[],[],[],[],[],,0.0256581,"This randomized resonant metamaterial presents a new perspective for single-sensor vibration sensing via vibration transmission encoding, and potentially offers an approach to simpler sensing devices for many other physical information.","[{'ForeName': 'Tianxi', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': ""State Key Laboratory of Mechanical System and Vibration, Shanghai Jiao Tong University, 200240, Shanghai, People's Republic of China.""}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""State Key Laboratory of Mechanical System and Vibration, Shanghai Jiao Tong University, 200240, Shanghai, People's Republic of China.""}, {'ForeName': 'Qingbo', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': ""State Key Laboratory of Mechanical System and Vibration, Shanghai Jiao Tong University, 200240, Shanghai, People's Republic of China. qbhe@sjtu.edu.cn.""}, {'ForeName': 'Zhi-Ke', 'Initials': 'ZK', 'LastName': 'Peng', 'Affiliation': ""State Key Laboratory of Mechanical System and Vibration, Shanghai Jiao Tong University, 200240, Shanghai, People's Republic of China.""}]",Nature communications,['10.1038/s41467-020-15950-1']
95,32393793,Persistent cannabis use as an independent risk factor for violent behaviors in patients with schizophrenia.,"Although recent studies have shown a moderately strong association between cannabis use and violence among people with severe mental disorders, the direction of this association has not been investigated prospectively in a population with schizophrenia. Therefore, this study aims to determine, using cross-lag models, whether a temporal relationship between cumulative cannabis use and violence exists in a population with schizophrenia. The authors reported findings covering an 18-month period from a randomized, double-blind clinical trial of antipsychotic medications for schizophrenia treatment. Among the 1460 patients enrolled in the trial, 965 were followed longitudinally. Although persistent cannabis use predicted subsequent violence, violence did not predict cannabis use. The relationship was therefore unidirectional and persisted when controlling for stimulants and alcohol use. Finally, a significant body of evidence suggests a link between persistent cannabis use and violence among people with mental illnesses. Studies to further investigate the mechanisms underlying this association should be conducted.",2020,"Although persistent cannabis use predicted subsequent violence, violence did not predict cannabis use.","['people with severe mental disorders', '1460 patients enrolled in the trial, 965 were followed longitudinally', 'population with schizophrenia', 'people with mental illnesses', 'patients with schizophrenia']",['antipsychotic medications'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",[],1460.0,0.267235,"Although persistent cannabis use predicted subsequent violence, violence did not predict cannabis use.","[{'ForeName': 'Mélissa', 'Initials': 'M', 'LastName': 'Beaudoin', 'Affiliation': ""Centre de recherche de l'Institut universitaire en santé mentale de Montréal, Montreal, QC, Canada. Melissa.Beaudoin.1@UMontreal.ca.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Potvin', 'Affiliation': ""Centre de recherche de l'Institut universitaire en santé mentale de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Charles-Edouard', 'Initials': 'CE', 'LastName': 'Giguère', 'Affiliation': ""Centre de recherche de l'Institut universitaire en santé mentale de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Sophie-Lena', 'Initials': 'SL', 'LastName': 'Discepola', 'Affiliation': ""Centre de recherche de l'Institut universitaire en santé mentale de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Dumais', 'Affiliation': ""Centre de recherche de l'Institut universitaire en santé mentale de Montréal, Montreal, QC, Canada. Alexandre.Dumais@UMontreal.ca.""}]",NPJ schizophrenia,['10.1038/s41537-020-0104-x']
96,32394625,"Corrigendum to ""Models of Variability and Circadian Rhythm in Heart Rate, Blood Pressure, and QT Interval for Healthy Subjects Who Received Placebo in Phase I Trials"".",,2020,,['Healthy Subjects'],['Placebo'],"['Variability and Circadian Rhythm in Heart Rate, Blood Pressure, and QT Interval']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",,0.0401805,,[],Clinical and translational science,['10.1111/cts.12773']
97,32361223,Comparison of programmed intermittent epidural bolus and continuous epidural infusion for post-operative analgesia after major abdominal surgery: A randomized controlled trial.,"STUDY OBJECTIVE


Few studies have compared continuous epidural infusion (CEI) against programmed intermittent epidural bolus (PIEB) epidural analgesia after major abdominal surgery. It has not been established whether the modality of epidural medication administration affects postoperative pain and other patient outcomes. The goal of this study was to compare the efficacy of PIEB against CEI in postoperative pain management after a broad range of surgeries with abdominal incisions, all managed in the context of an established enhanced recovery after surgery (ERAS) pathway.
DESIGN


Prospective, randomized, controlled trial.
SETTING


Postoperative acute care.
PATIENTS


120 patients scheduled for major surgery involving abdominal incisions with planned postoperative epidural analgesia were enrolled as study participants.
INTERVENTIONS


All subjects received a standardized epidural solution containing ropivacaine 0.0625% and fentanyl 2 μg/ml. The CEI group received this solution as a continuous infusion, while the PIEB group received this solution as programmed intermittent boluses.
MEASUREMENTS


The primary study outcome was the total local anesthetic used over the first 24 h post-operatively. Secondary outcomes included pain severity, pain interference, total opioid consumption, patient satisfaction, and adverse effects at 24, 48, and 72 h postoperatively.
MAIN RESULTS


There was no difference in the primary outcome of total amount of local anesthetic administered in the first 24-hour postoperative period (PIEB: 123 mg [Interquartile Range (IQR): 114-136]; CEI: 126 mg [IQR: 120-134]). There were also no differences in average pain severity, total opioid consumption, patient satisfaction, number of PCEA requests and incidence of adverse events at 24, 48, and 72 h postoperatively.
CONCLUSIONS


Our study suggests that within the context of an established ERAS program, PIEB and CEI modes of epidural analgesia can be equally efficacious and safe in providing postoperative analgesia after major abdominal surgery.",2020,There was no difference in the primary outcome of total amount of local anesthetic administered in the first 24-hour postoperative period (PIEB:,"['post-operative analgesia after major abdominal surgery', '120 patients scheduled for major surgery involving abdominal incisions with planned postoperative epidural analgesia were enrolled as study participants']","['PIEB against CEI', 'standardized epidural solution containing ropivacaine', 'continuous epidural infusion', 'CEI']","['total amount of local anesthetic administered in the first 24-hour postoperative period (PIEB', 'total local anesthetic used over the first 24\xa0h post-operatively', 'average pain severity, total opioid consumption, patient satisfaction, number of PCEA requests and incidence of adverse events', 'pain severity, pain interference, total opioid consumption, patient satisfaction, and adverse effects']","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0198488', 'cui_str': 'Abdomen incision'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1301707', 'cui_str': 'Patient controlled epidural analgesia'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",120.0,0.371242,There was no difference in the primary outcome of total amount of local anesthetic administered in the first 24-hour postoperative period (PIEB:,"[{'ForeName': 'Po-Yi Paul', 'Initials': 'PP', 'LastName': 'Su', 'Affiliation': 'University of California San Francisco, United States of America. Electronic address: paul.su@ucsf.edu.'}, {'ForeName': 'Alec', 'Initials': 'A', 'LastName': 'Peniche', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Elle', 'Initials': 'E', 'LastName': 'Clelland', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ladd', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Delgado', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Lee-Lynn', 'Initials': 'LL', 'LastName': 'Chen', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Claas', 'Initials': 'C', 'LastName': 'Siegmueller', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Latronica', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Ramana', 'Initials': 'R', 'LastName': 'Naidu', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Pedram', 'Initials': 'P', 'LastName': 'Aleshi', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Behrends', 'Affiliation': 'University of California San Francisco, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109850']
98,32360692,Acute and residual mood and cognitive performance of young adults following smoked cannabis.,"OBJECTIVES


To examine acute and residual mood and cognitive performance in young adult regular cannabis users following smoked cannabis.
METHODS


Ninety-one healthy young adults completed this double-blind, placebo-controlled, parallel-groups study. Participants were randomized to receive active (12.5% THC) or placebo cannabis with a 2:1 allocation ratio, and mood [Profile of Mood States (POMS)] and cognitive performance [Hopkins Verbal Learning Test - Revised (HVLT-R), Digit Symbol Substitution Test (DSST), Continuous Performance Test (CPT), grooved pegboard (GPB)] were assessed before and 1, 24, and 48 (h) after smoking cannabis ad libitum. High and Low THC groups were based on blood THC concentrations.
RESULTS


One hour after smoking cannabis, compared to Placebo, in both the High and Low THC groups, there were increases in POMS Arousal and Positive Mood, and in the High THC group only, increases in Confusion, Friendliness, and Elation, and a decrease in Fatigue. Increases in Friendliness and Elation in the High THC group remained significant for 24 h. The only significant acute effect of cannabis on cognition was a decrease in the percent of words retained in the HVLT-R in the High THC group compared to Placebo (mean difference = 15.8%, 95% CI = 3.6-28.0%, p = 0.006). Unexpectedly, compared to Placebo, both the High and Low THC groups improved in DSST performance at 48 h (p ≤ 0.016).
CONCLUSIONS


Under the present experimental conditions, in young regular cannabis users, smoking cannabis ad libitum had significant effects on mood, some of which persisted 24 h later, yet minimal effects on cognition, and no evidence of residual cognitive impairment.",2020,"Unexpectedly, compared to Placebo, both the High and Low THC groups improved in DSST performance at 48 h (p ≤ 0.016).
","['young adult regular cannabis users following smoked cannabis', 'Ninety-one healthy young adults', 'young adults following smoked cannabis', 'young regular cannabis users']","['High and Low', 'Placebo', 'placebo cannabis with a 2:1 allocation ratio, and mood', 'placebo']","['Confusion, Friendliness, and Elation', 'blood THC concentrations', 'Fatigue', 'Mood States (POMS)] and cognitive performance [Hopkins Verbal Learning Test - Revised (HVLT-R), Digit Symbol Substitution Test (DSST), Continuous Performance Test (CPT), grooved pegboard (GPB', 'Friendliness and Elation', 'Acute and residual mood and cognitive performance', 'POMS Arousal and Positive Mood', 'DSST performance']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]","[{'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0233492', 'cui_str': 'Elation'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C3490329', 'cui_str': 'glycerol phenylbutyrate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",91.0,0.263829,"Unexpectedly, compared to Placebo, both the High and Low THC groups improved in DSST performance at 48 h (p ≤ 0.016).
","[{'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Matheson', 'Affiliation': ""Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, 27 King's College Circle, Toronto, Ontario M5S3H7, Canada; Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada. Electronic address: justin.matheson@camh.ca.""}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Mann', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada; Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, Ontario M5T3M7, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, 250 College Street, Toronto, Ontario M5T1R8, Canada.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Sproule', 'Affiliation': 'Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, Ontario M5S3M2, Canada; Pharmacy Department, Centre for Addiction and Mental Health, 1001 Queen Street, Toronto, Ontario M6J1H4, Canada; Department of Psychiatry, Faculty of Medicine, University of Toronto, 250 College Street, Toronto, Ontario M5T1R8, Canada.'}, {'ForeName': 'Marilyn A', 'Initials': 'MA', 'LastName': 'Huestis', 'Affiliation': 'Institute of Emerging Health Professions, Thomas Jefferson University, 1020 Walnut Street, Philadelphia, PA 19107, United States.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Wickens', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada; Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, Ontario M5T3M7, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, 250 College Street, Toronto, Ontario M5T1R8, Canada.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Stoduto', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada.'}, {'ForeName': 'Tony P', 'Initials': 'TP', 'LastName': 'George', 'Affiliation': ""Department of Psychiatry, Faculty of Medicine, University of Toronto, 250 College Street, Toronto, Ontario M5T1R8, Canada; Addictions Division, Centre for Addiction and Mental Health, 100 Stokes Street, Toronto, Ontario M6J1H4, Canada; Institute of Medical Sciences, University of Toronto, 1 King's College Circle, Room 2374, Toronto, Ontario M5S 1A8, Canada.""}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Rehm', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada; Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, Ontario M5T3M7, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, 250 College Street, Toronto, Ontario M5T1R8, Canada; Department of Psychiatry, Faculty of Medicine, University of Toronto, 250 College Street, Toronto, Ontario M5T1R8, Canada.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Le Foll', 'Affiliation': ""Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, 27 King's College Circle, Toronto, Ontario M5S3H7, Canada; Department of Psychiatry, Faculty of Medicine, University of Toronto, 250 College Street, Toronto, Ontario M5T1R8, Canada; Addictions Division, Centre for Addiction and Mental Health, 100 Stokes Street, Toronto, Ontario M6J1H4, Canada; Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada; Department of Family and Community Medicine, University of Toronto, 500 University Avenue, 5th Floor, Toronto, Ontario M5G 1V7, Canada.""}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Brands', 'Affiliation': ""Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, 27 King's College Circle, Toronto, Ontario M5S3H7, Canada; Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada; Controlled Substances and Cannabis Directorate, Health Canada, Ottawa, Ontario, Canada.""}]","Pharmacology, biochemistry, and behavior",['10.1016/j.pbb.2020.172937']
99,32372294,Pharmacokinetics of Ambroxol Sustained Release (Mucosolvan ®  Retard) Compared with Other Formulations in Healthy Volunteers.,"INTRODUCTION


Ambroxol is used in the treatment of acute and chronic respiratory conditions characterized by abnormal mucus secretion and impaired mucus transport and is available in a variety of formulations. This study aimed to compare the steady-state (SS) pharmacokinetic characteristics of extended-release (ER) 75-mg retard capsules with two immediate-release (IR) formulations (60-mg effervescent tablets and 30-mg tablets) over a 24-h period.
METHODS


An open-label, randomized, three-period, six-sequence crossover study was conducted in healthy volunteers aged 18-45 years who had a normal body mass index. The test (ER 75-mg retard capsule once daily) and reference treatments (half of IR 60-mg effervescent tablet twice daily or 30-mg IR tablet twice daily) were administered on days 1-5 of each treatment period. Meals were standardized and concomitant therapy was prohibited. Blood samples for pharmacokinetic assessment were collected on day 5 (SS) of each treatment period. The co-primary endpoints were exposure (AUC SS 0-24 ) and maximum plasma level (C max SS ).
RESULTS


Twenty-four participants received ambroxol (male n = 13, 54.2%; mean ± standard deviation [SD] age 25.0 ± 6.4 years) and 23 completed the study. ER retard capsules provided similar AUC SS 0-24  compared to IR tablets (geometric means ratio [GMR] 110.7%; 90% confidence interval [CI] 99.8%, 122.7%) and effervescent tablets (GMR 106.9%; 90% CI 100.3%, 114.0%). ER retard capsules provided similar C max SS  compared to IR tablets (GMR 84.7%, 90% CI 77.0%, 93.3%), and lower C max SS  compared to effervescent tablets (GMR 80.9%, 90% CI 73.9%, 88.6%). Time to C max SS  (t max SS ) was longer with ER retard capsules (6.0 h) than with IR tablets (2.0 h) or effervescent tablets (1.0 h).
CONCLUSIONS


ER ambroxol 75-mg retard capsules given once daily showed a similar pharmacokinetic profile to IR ambroxol formulations and therefore can be used instead of these in the treatment of respiratory conditions. CLINICALTRIALS.
GOV IDENTIFIER


NCT02036775.",2020,"ER retard capsules provided similar C max SS  compared to IR tablets (GMR 84.7%, 90% CI 77.0%, 93.3%), and lower C max SS  compared to effervescent tablets (GMR 80.9%, 90% CI 73.9%, 88.6%).","['Healthy Volunteers', 'Twenty-four participants received ambroxol (male n\u2009=\u200913, 54.2%; mean\u2009±\u2009standard deviation [SD] age 25.0\u2009±\u20096.4\xa0years) and 23 completed the study', 'healthy volunteers aged 18-45\xa0years who had a normal body mass index']","['Ambroxol', 'Ambroxol Sustained Release (Mucosolvan ®  Retard', 'extended-release (ER) 75-mg retard capsules with two immediate-release (IR) formulations']","['exposure (AUC SS 0-24 ) and maximum plasma level (C max SS ', 'steady-state (SS) pharmacokinetic characteristics', 'Time to C max']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0002421', 'cui_str': 'Ambroxol'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517808', 'cui_str': '54.2'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0231253', 'cui_str': 'Normal body mass index'}]","[{'cui': 'C0002421', 'cui_str': 'Ambroxol'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0023091', 'cui_str': 'Surbronc'}, {'cui': 'C0521111', 'cui_str': 'Retarded'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0673296,"ER retard capsules provided similar C max SS  compared to IR tablets (GMR 84.7%, 90% CI 77.0%, 93.3%), and lower C max SS  compared to effervescent tablets (GMR 80.9%, 90% CI 73.9%, 88.6%).","[{'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Ollier', 'Affiliation': 'PKDM-TMED Department, Sanofi-Aventis, PK-Biopharm, Montpellier, France.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Sent', 'Affiliation': 'Sanofi-Aventis, CHC Medical Affairs, Frankfurt am Main, Germany. ulrike.sent@sanofi.com.'}, {'ForeName': 'Margarida', 'Initials': 'M', 'LastName': 'Mesquita', 'Affiliation': 'Sanofi-Aventis, CHC Medical Affairs, Frankfurt am Main, Germany.'}, {'ForeName': 'Martin C', 'Initials': 'MC', 'LastName': 'Michel', 'Affiliation': 'Department of Pharmacology, Johannes Gutenberg Universität, Mainz, Germany.'}]",Pulmonary therapy,['10.1007/s41030-020-00116-7']
100,32378975,Effect of neuromuscular electrical stimulation on skeletal muscle size and function in patients with breast cancer receiving chemotherapy.,"Exercise has numerous benefits for patients with cancer, but implementation is challenging because of practical and logistical hurdles. This study examined whether neuromuscular electrical stimulation (NMES) can serve as a surrogate for classical exercise by eliciting an exercise training response in skeletal muscle of women diagnosed with breast cancer undergoing chemotherapy. Patients (n=22) with histologically-confirmed, stage I, II or III breast cancer scheduled to receive neoadjuvant or adjuvant chemotherapy were randomized to 8 weeks of bilateral neuromuscular electrical stimulation (NMES; 5 days/week) to their quadriceps muscles or control. Biopsy of the vastus lateralis was performed at baseline and after 8 weeks of intervention to assess muscle fiber size, contractility and mitochondrial content. Seventeen patients (8 control/9 NMES) completed the trial and were included in analyses. NMES promoted muscle fiber hypertrophy (P<0.001), particularly in fast-twitch, myosin heavy chain (MHC) IIA fibers (P<0.05), and tended to induce fiber type shifts in MHC II fibers. The effects of NMES on single muscle fiber contractility were modest and it was unable to prevent declines in function in MHC IIA fibers. NMES did not alter intermyofibrillar mitochondrial content/structure, but was associated with reductions in subsarcolemmal mitochondria. Our results demonstrate that NMES induces muscle fiber hypertrophy and fiber type shifts in MHC II fibers, but had minimal effects on fiber contractility and promoted reductions in subsarcolemmal mitochondria. Further studies are warranted to evaluate the utility of NMES as an exercise surrogate in cancer patients and other conditions.",2020,"NMES promoted muscle fiber hypertrophy (P<0.001), particularly in fast-twitch, myosin heavy chain (MHC)","['patients with cancer', 'Seventeen patients (8 control/9 NMES) completed the trial and were included in analyses', 'Patients (n=22) with histologically-confirmed, stage I, II or III breast cancer scheduled to receive', 'women diagnosed with breast cancer undergoing chemotherapy', 'patients with breast cancer receiving chemotherapy']","['neuromuscular electrical stimulation', 'NMES', 'neuromuscular electrical stimulation (NMES', 'neoadjuvant or adjuvant chemotherapy', 'bilateral neuromuscular electrical stimulation (NMES; 5 days/week) to their quadriceps muscles or control', 'Exercise']","['fast-twitch, myosin heavy chain (MHC', 'skeletal muscle size and function', 'muscle fiber hypertrophy', 'subsarcolemmal mitochondria']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0027100', 'cui_str': 'Myosin Heavy Chain'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0333759', 'cui_str': 'Muscle fiber hypertrophy'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}]",22.0,0.0485888,"NMES promoted muscle fiber hypertrophy (P<0.001), particularly in fast-twitch, myosin heavy chain (MHC)","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Toth', 'Affiliation': 'Department of Medicine, University of Vermont, United States.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Voigt', 'Affiliation': 'Department of Medicine, University of Vermont, United States.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Tourville', 'Affiliation': 'Department of Orthopedics and Rehabilitation, University of Vermont, United States.'}, {'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Prior', 'Affiliation': 'The Vermont Cancer Center, University of Vermont, United States.'}, {'ForeName': 'Blas A', 'Initials': 'BA', 'LastName': 'Guigni', 'Affiliation': 'Departments of Medicine, Molecular Physiology and Biophysics, University of Vermont, United States.'}, {'ForeName': 'Axel V', 'Initials': 'AV', 'LastName': 'Schlosberg', 'Affiliation': 'Department of Medicine, University of Vermont, United States.'}, {'ForeName': 'Isaac B', 'Initials': 'IB', 'LastName': 'Smith', 'Affiliation': 'Department of Medicine, University of Vermont, United States.'}, {'ForeName': 'Taylor J', 'Initials': 'TJ', 'LastName': 'Forest', 'Affiliation': 'Department of Medicine, University of Vermont, United States.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Kaufman', 'Affiliation': 'Department of Medicine, University of Vermont, United States.'}, {'ForeName': 'Marie E', 'Initials': 'ME', 'LastName': 'Wood', 'Affiliation': 'Department of Medicine, University of Vermont, United States.'}, {'ForeName': 'Hibba', 'Initials': 'H', 'LastName': 'Rehman', 'Affiliation': 'Department of Medicine, University of Vermont, United States.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dittus', 'Affiliation': 'Departments of Medicine, University of Vermont, United States.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00203.2020']
101,32375661,The effect of digital reminiscence therapy on people with dementia: a pilot randomized controlled trial.,"BACKGROUND


Reminiscence therapy (RT) can improve various dysfunctions in people with dementia (PWD), but it may not be a cost-effective intervention. Digital RT allows multiple users to participate in a therapy simultaneously. Moreover, digital RT offers convenience, such as for uploading personal materials and presenting individual triggers of personal memories. This pilot study aimed to evaluate the effect of digital RT through a comparison with conventional RT and to develop a strategy for designing larger RCTs.
METHODS


An Android application and digital content were developed for digital RT. Overall, 49 PWD enrolled in nine daycare centers in Korea met the inclusion criteria. Eight sessions of digital RT in an intervention group (n = 25) and storytelling in a control group (n = 24) with no digital materials were performed over 4 weeks from February to June 2019. Cognition, depression, behavioral and psychological symptoms of dementia (BPSD), and engagement were measured as the primary outcomes to evaluate the effect of digital RT. All outcomes except for engagement were evaluated at baseline before the intervention (T0), post-intervention (T1), and 4 weeks after the intervention (T2). Engagement was measured at the first and last intervention sessions. Differences in cognition, depression and BPSD between groups and across time points (T0, T1, and T2) were analyzed by repeated measures ANOVA. Differences in engagement between the groups and time points (the first and last sessions) were analyzed by independent t-tests. This study adhered to the CONSORT guidelines.
RESULTS


Depression (F = 7.62, p = .001, partial η 2  = .17) was significantly decreased at T1 and T2, and engagement (t = - 2.71, p = .011) was significantly increased at the last session in the digital RT group compared to the control group. However, cognition (F = 0.13, p = .821) and BPSD (F = 0.67, p = .485) were not significantly different between groups and time points.
CONCLUSIONS


Digital RT proved an innovative approach to manage PWD and will thus help PWD achieve a better mood and have more opportunities to engage in social interactions.
TRIAL REGISTRATION


KCT0003446 in the Clinical Research Information Service. Registered 24 January 2019, https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=14391.",2020,"However, cognition (F = 0.13, p = .821) and BPSD (F = 0.67, p = .485) were not significantly different between groups and time points.
","['49 PWD enrolled in nine daycare centers in Korea met the inclusion criteria', 'people with dementia (PWD', 'people with dementia']","['digital RT', 'digital reminiscence therapy', 'Reminiscence therapy (RT', 'storytelling in a control group (n\u2009=\u200924) with no digital materials']","['BPSD', 'Cognition, depression, behavioral and psychological symptoms of dementia (BPSD), and engagement', 'cognition, depression and BPSD']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0150321', 'cui_str': 'Reminiscence therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",,0.0423374,"However, cognition (F = 0.13, p = .821) and BPSD (F = 0.67, p = .485) were not significantly different between groups and time points.
","[{'ForeName': 'SeolHwa', 'Initials': 'S', 'LastName': 'Moon', 'Affiliation': 'College of Nursing, Hanyang University, 222 Wangsimni-ro, Sungdong-gu, Seoul, 04763, Korea.'}, {'ForeName': 'Kyongok', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Department of Nursing, Gangneung-Wonju National University, 150 Namwon-ro, Heungeop-myeon, Wonju-si, Gangwon-do, 26403, Korea. kopark@gwnu.ac.kr.'}]",BMC geriatrics,['10.1186/s12877-020-01563-2']
102,32381105,Educational strategy for the development of skills in exchange transfusion: a randomized clinical trial protocol.,"BACKGROUND


Exchange transfusion is a highly complex procedure that requires high levels of expertise. Trainee paediatricians do not have adequate training in exchange transfusion because opportunities to perform this procedure in practice are scarce. This protocol seeks to compare two educational interventions for exchange transfusion that allow students to develop competencies to perform the technique in an appropriate and safe way.
METHODS/DESIGN


This is a randomized parallel single-blind clinical trial with allocation by simple randomization to the educational intervention (simulation or a digital didactic environment). Students from the paediatric specialization who volunteer to participate will be included. A practical evaluation of the procedure will be performed through a simulated scenario using a standardized clinical case. The main outcome is defined as the result of evaluation using the Objective Structured Clinical Examination; superior performance will be defined when the percentage is greater than or equal to 85%, and non-superior performance will be defined when the result is less than 84%. The chi-square independence test or the Fisher exact test will be used to evaluate the effect of the interventions. Multivariate analysis will be performed using a non-conditional logistic regression model. Stata 15® software will be used.
DISCUSSION


Exchange transfusion is a procedure that requires expertise to achieve adequate outcomes. The inclusion of new educational strategies, such as simulation and digital didactic environments, is seen as a training option that can improve performance in clinical skills, reduce adverse events and increase the level of trust.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT04070066. Registered on 28 August 2019. https://clinicaltrials.gov.",2020,"This protocol seeks to compare two educational interventions for exchange transfusion that allow students to develop competencies to perform the technique in an appropriate and safe way.
",['Students from the paediatric specialization who volunteer to participate will be included'],['educational intervention (simulation or a digital didactic environment'],[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0037776', 'cui_str': 'Specialization'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]",[],,0.184376,"This protocol seeks to compare two educational interventions for exchange transfusion that allow students to develop competencies to perform the technique in an appropriate and safe way.
","[{'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Maldonado', 'Affiliation': 'School of Medicine, Master in Medical Education, Universidad de La Sabana (University of La Sabana), Chía, Colombia. maria.maldonado5@unisabana.edu.co.'}, {'ForeName': 'Sergio Iván', 'Initials': 'SI', 'LastName': 'Agudelo', 'Affiliation': 'School of Medicine, Universidad de La Sabana, Chía, Colombia.'}, {'ForeName': 'Juan David', 'Initials': 'JD', 'LastName': 'Suarez', 'Affiliation': 'School of Medicine, Universidad de La Sabana, Chía, Colombia.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Gamboa', 'Affiliation': 'School of Medicine, Universidad de La Sabana, Chía, Colombia.'}]",Trials,['10.1186/s13063-020-04312-3']
103,32381110,"Opposing needling for analgesia and rehabilitation after unilateral total knee arthroplasty: a randomized, sham-controlled trial protocol.","BACKGROUND


This randomized controlled clinical trial aims to evaluate the efficacy and safety of opposing needling in patients undergoing unilateral total knee arthroplasty (TKA). Opposing needling is one of the special needling methods used in acupuncture and moxibustion therapy. It involves needling acupoints on the contralateral side for pain management. Although, opposing needling is used for pain management in clinics, evidence to support its effectiveness as an analgesic after total knee arthroplasty is scant. We designed a randomized controlled clinical trial to evaluate efficacy and safety of opposing electroacupuncture (EA) in alleviating pain associated with unilateral total knee arthroplasty.
METHODS/DESIGN


This is a protocol for a randomized controlled patient- and assessor-blinded trial with three parallel arms (A, opposing EA; B, operated side EA; C, sham EA). Yinlingquan (SP9), Yanglingquan (GB34), Futu (ST32), and Zusanli (ST36) acupoints are selected for all three groups. In group A, the healthy side will be treated with EA, while the operated side will be administered sham EA. In group B, the operated side will be treated with EA while on the healthy side sham EA will be used. For group C, sham EA will be used on both sides. All patients in the three groups will receive treatment once a day for 3 days. The post-operative pain measured using a visual analogue scale score (including pain while resting and being active) and the additional dose of the patient-controlled analgesic pump after operation will be recorded as the primary outcomes. Secondary outcomes such as knee function and swelling, range of motion (including active and passive range of motion), post-operative anxiety, and acupuncture tolerance will also be assessed.
DISCUSSION


Opposing needling is a potential non-pharmacological treatment for relieving pain and improving functional rehabilitation after TKA, during which patients receive acupuncture on the healthy side rather than on the operated side. This sham controlled clinical trial, designed to evaluate efficacy and safety of opposing needling for patients after TKA, will provide evidence for pain management and functional rehabilitation after unilateral TKA.
TRIAL REGISTRATION


ChiCTR, ChiCTR1800020297 (http://www.chictr.org.cn/edit.aspx?pid=34231&htm=4). Registered 22 December 2018.",2020,"Opposing needling is a potential non-pharmacological treatment for relieving pain and improving functional rehabilitation after TKA, during which patients receive acupuncture on the healthy side rather than on the operated side.","['after unilateral total knee arthroplasty', 'patients undergoing unilateral total knee arthroplasty (TKA', 'pain associated with unilateral total knee arthroplasty']","['electroacupuncture (EA', 'acupuncture', 'needling acupoints', 'opposing needling', 'Opposing needling for analgesia and rehabilitation', 'acupuncture and moxibustion therapy']","['visual analogue scale score (including pain while resting and being active', 'efficacy and safety', 'knee function and swelling, range of motion (including active and passive range of motion), post-operative anxiety, and acupuncture tolerance will also be assessed', 'Yinlingquan (SP9), Yanglingquan (GB34), Futu (ST32), and Zusanli (ST36) acupoints']","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}]",,0.201172,"Opposing needling is a potential non-pharmacological treatment for relieving pain and improving functional rehabilitation after TKA, during which patients receive acupuncture on the healthy side rather than on the operated side.","[{'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Guanghua Hospital, Shanghai University of Traditional Chinese Medicine, 540 Xinhua Rd., Shanghai, 200052, China.'}, {'ForeName': 'Xiuling', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Shanghai University of Traditional Chinese Medicine, 1200 Cailun Rd., Shanghai, 201203, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Shanghai University of Traditional Chinese Medicine, 1200 Cailun Rd., Shanghai, 201203, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'Guanghua Hospital, Shanghai University of Traditional Chinese Medicine, 540 Xinhua Rd., Shanghai, 200052, China.'}, {'ForeName': 'Lianbo', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Guanghua Hospital, Shanghai University of Traditional Chinese Medicine, 540 Xinhua Rd., Shanghai, 200052, China. xiao_lianbo@163.com.'}, {'ForeName': 'Yuelai', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Shanghai University of Traditional Chinese Medicine, 1200 Cailun Rd., Shanghai, 201203, China. chen_yuelai@163.com.'}]",Trials,['10.1186/s13063-020-04251-z']
104,32385307,Randomized controlled trial of medium cut-off versus high-flux dialyzers on quality of life outcomes in maintenance hemodialysis patients.,"Medium cut-off (MCO) dialyzers help remove larger middle molecules associated with symptoms related to the accumulation of uremic retention solutes. We investigated the effect of an MCO dialyzer on the improvement of quality of life (QOL) in maintenance hemodialysis (HD) patients. Forty-nine HD patients with high-flux dialysis were randomly assigned to either an MCO (Theranova 400, Baxter) or a high-flux (FX CorDiax 80 or 60, Fresenius Medical Care) dialyzer and completed the study. QOL was assessed at baseline and after 12 weeks of treatment using the Kidney Disease Quality of Life Short Form-36, and pruritus was assessed using a questionnaire and visual analog scale. The reduction ratios of middle molecules were also evaluated. Laboratory markers, including serum albumin, did not differ between the two groups after 12 weeks. Removals of kappa and lambda free light chains were greater for MCO dialyzer than high-flux dialyzer. The MCO group had higher scores than the high-flux group in the domains of physical functioning and physical role (75.2 ± 20.8 vs. 59.8 ± 30.1, P = 0.042; 61.5 ± 37.6 vs. 39.0 ± 39.6, P = 0.047, respectively), and the MCO group had lower mean scores for morning pruritus distribution and the frequency of scratching during sleep (1.29 ± 0.46 vs. 1.64 ± 0.64, P = 0.034; 0.25 ± 0.53 vs. 1.00 ± 1.47, P = 0.023, respectively). MCO dialyzers may improve patient-reported outcomes, particularly the physical components of QOL and uremic pruritus, in patients with high-flux dialyzers.",2020,"The MCO group had higher scores than the high-flux group in the domains of physical functioning and physical role (75.2 ± 20.8 vs. 59.8 ± 30.1, P = 0.042; 61.5 ± 37.6 vs. 39.0 ± 39.6, P = 0.047, respectively), and the MCO group had lower mean scores for morning pruritus distribution and the frequency of scratching during sleep (1.29 ± 0.46 vs. 1.64 ± 0.64, P = 0.034; 0.25 ± 0.53 vs. 1.00 ± 1.47, P = 0.023, respectively).","['maintenance hemodialysis (HD) patients', 'maintenance hemodialysis patients', 'patients with high-flux dialyzers', 'Forty-nine HD patients with high-flux dialysis']","['Medium cut-off (MCO) dialyzers', 'MCO dialyzer', 'MCO (Theranova 400, Baxter) or a high-flux (FX CorDiax 80 or 60, Fresenius Medical Care) dialyzer', 'medium cut-off versus high-flux dialyzers', 'MCO dialyzers', 'MCO']","['reduction ratios of middle molecules', 'serum albumin', 'Removals of kappa and lambda free light chains', 'QOL', 'quality of life (QOL', 'questionnaire and visual analog scale', 'Kidney Disease Quality of Life Short Form-36, and pruritus', 'quality of life outcomes', 'frequency of scratching during sleep']","[{'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}]","[{'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C1720314', 'cui_str': 'Lambda'}, {'cui': 'C0806492', 'cui_str': 'Free immunoglobulin light chain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0311213', 'cui_str': 'Dermatitis verrucosa'}, {'cui': 'C0587116', 'cui_str': 'During sleep'}]",49.0,0.0435656,"The MCO group had higher scores than the high-flux group in the domains of physical functioning and physical role (75.2 ± 20.8 vs. 59.8 ± 30.1, P = 0.042; 61.5 ± 37.6 vs. 39.0 ± 39.6, P = 0.047, respectively), and the MCO group had lower mean scores for morning pruritus distribution and the frequency of scratching during sleep (1.29 ± 0.46 vs. 1.64 ± 0.64, P = 0.034; 0.25 ± 0.53 vs. 1.00 ± 1.47, P = 0.023, respectively).","[{'ForeName': 'Jeong-Hoon', 'Initials': 'JH', 'LastName': 'Lim', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Yeongwoo', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'Department of Statistics, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Ju-Min', 'Initials': 'JM', 'LastName': 'Yook', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Soon-Youn', 'Initials': 'SY', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Hee-Yeon', 'Initials': 'HY', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Ji-Young', 'Initials': 'JY', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Sun-Hee', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Chan-Duck', 'Initials': 'CD', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Yong-Lim', 'Initials': 'YL', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Jang-Hee', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea. jh-cho@knu.ac.kr.'}]",Scientific reports,['10.1038/s41598-020-64622-z']
105,32391263,A Retrospective Exploration of Targeted Maintenance Therapy in Advanced Colorectal Cancer: Based on the Background of Chinese Patient Assistance Program.,"Background:  Maintenance therapy with bevacizumab (Bev) in patients with colorectal cancer (CRC) provides progression-free survival (PFS) benefits. However, the role of maintenance therapy with an anti-EGFR monoclonal antibody has not been established.  Methods:  Eligible CRC patients were assigned to maintenance therapy with cetuximab (Cet; Cet group) or Bev (Bev group). PFS, the duration of maintenance therapy, and safety were analyzed. Cox multivariate regression analyses were performed to determine independent prognostic factors.  Results:  A total of 143 eligible patients were assigned to the Cet ( n  = 79) or Bev ( n  = 64) groups. In the Cet group, all patients had KRAS wild-type. The baseline characteristics were well-balanced between the two groups, except for a higher percentage of patients with a left-sided primary tumor in the Cet group than in the Bev group (86.1 vs. 62.5%,  P  < 0.0001). The median PFS was not significantly different between the Cet group and the Bev group: 5.9 months (95% CI 2.30-9.50) vs. 7.0 months (95% CI 3.69-10.31) (HR 1.17, 95% CI 0.77-1.79,  P  = 0.45). The median duration of maintenance therapy in the Cet group was shorter than that in the Bev group: 4.0 months (95% CI 1.94-5.99) vs. 4.8 months (95% CI 2.68-6.98) (HR 0.90, 95% CI 0.61-1.33;  P  = 0.59). The subgroup analyses showed that the median PFS for the first maintenance therapy and the second maintenance therapy were 3.2 months (95% CI 1.69-4.78) and 5.2 months (95% CI 1.58-8.83), respectively (HR 0.89, 95% CI 0.44-1.81;  P  = 0.75).  Conclusions:  This study suggests that maintenance therapy with Cet or Bev can be considered an appropriate option following induction chemotherapy for selected patients with advanced CRC. Multiple maintenance therapy seems to confer survival benefits in advanced CRC. Maintenance therapy with Cet after first-line induction chemotherapy seems to be associated with greater survival benefits.",2020,"The median PFS was not significantly different between the Cet group and the Bev group: 5.9 months (95% CI 2.30-9.50) vs. 7.0 months (95% CI 3.69-10.31) (HR 1.17, 95% CI 0.77-1.79,  P  = 0.45).","['selected patients with advanced CRC', 'patients with colorectal cancer (CRC', 'Advanced Colorectal Cancer', 'Eligible CRC patients', '143 eligible patients were assigned to the Cet ( n  = 79) or Bev ( n  = 64) groups']","['maintenance therapy with cetuximab (Cet; Cet group) or Bev (Bev group', 'bevacizumab (Bev']","['median duration of maintenance therapy', 'PFS, the duration of maintenance therapy, and safety', 'survival benefits', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0007735', 'cui_str': 'Cephalothin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0007735', 'cui_str': 'Cephalothin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",143.0,0.0515908,"The median PFS was not significantly different between the Cet group and the Bev group: 5.9 months (95% CI 2.30-9.50) vs. 7.0 months (95% CI 3.69-10.31) (HR 1.17, 95% CI 0.77-1.79,  P  = 0.45).","[{'ForeName': 'Hanguang', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Departments of Medical Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Departments of Medical Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': 'Departments of Medical Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Dehao', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Cancer Institute (Key Laboratory of Cancer Prevention and Intervention, China National Ministry of Education), The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Junxi', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Departments of Medical Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Departments of Medical Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.00522']
106,32391304,Effects of a Participatory School-Based Intervention on Students' Health-Related Knowledge and Understanding.,"Introduction:  The development of knowledge and understanding in relation to movement and health is a basic requirement to facilitate lifelong engagement in physical activity with its accompanying possible health benefits. To train teachers in applying adequate strategies, implementation studies have often shown little acceptance of traditional top-down approaches. Thus, the purpose of the Health.edu project was to develop, implement and evaluate effective and feasible measures addressing students' health-related knowledge and understanding (HKU) in physical education (PE) via a participatory approach.  Materials and Methods:  For evaluation, a controlled pre-post-test study with 233 students from eight different secondary schools in Germany was carried out. Four schools (with two PE teachers at each school) comprised the intervention group and they participated in a 1-year participatory planning process to conceptualize and implement evidence-based PE lessons addressing students' HKU. Control schools carried out their regular PE lessons. Evaluation followed a mixed-methods research design, assessing program implementation via written documentary technique as well as program effectiveness using a standardized questionnaire.  Results:  Results show a significant intervention effect on students' HKU with a medium effect size. However, due to the participatory process, there were considerable differences between the intervention schools that were involved. Student's HKU improved most in schools where program implementation corresponded to relevant principles of fostering HKU.  Discussion:  The present study purposefully dispensed with any structured intervention programs for PE teachers to follow. The results show the potential effects of this participatory approach to strengthen student's HKU. However, the participatory planning does not always work in the intended manner, emphasizing that numerous contextual factors influence the implementation process.",2020,Results show a significant intervention effect on students' HKU with a medium effect size.,"['Four schools (with two PE teachers at each school', '233 students from eight different secondary schools in Germany was carried out', ""Students' Health-Related Knowledge and Understanding""]","[""1-year participatory planning process to conceptualize and implement evidence-based PE lessons addressing students' HKU"", 'Participatory School-Based Intervention']",[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],233.0,0.0189003,Results show a significant intervention effect on students' HKU with a medium effect size.,"[{'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Strobl', 'Affiliation': 'Institute of Sport Science, University of Bayreuth, Bayreuth, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Ptack', 'Affiliation': 'Institute of Sport Science, University of Bayreuth, Bayreuth, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Töpfer', 'Affiliation': 'Department of Sport Science and Sport, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Sygusch', 'Affiliation': 'Department of Sport Science and Sport, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Tittlbach', 'Affiliation': 'Institute of Sport Science, University of Bayreuth, Bayreuth, Germany.'}]",Frontiers in public health,['10.3389/fpubh.2020.00122']
107,32391374,An Acute Reduction in Habitual Protein Intake Attenuates Post Exercise Anabolism and May Bias Oxidation-Derived Protein Requirements in Resistance Trained Men.,"Protein recommendations for resistance-trained athletes are generally lower than their habitual intakes. Excess protein consumption increases the capacity to oxidize amino acids, which can attenuate post-exercise anabolism and may impact protein requirements determined by stable isotope techniques predicated on amino acid tracer oxidation. We aimed to determine the impact of an acute (5d) reduction in dietary protein intake on post-exercise anabolism in high habitual consumers using the indicator amino acid oxidation (IAAO) technique. Resistance trained men [ n  = 5; 25 ± 7 y; 73.0 ± 5.7 kg; 9.9 ± 2.9% body fat; 2.69 ± 0.38 g·kg -1 ·d -1  habitual protein intake) consumed a high (H; 2.2 g·kg -1 ·d -1 ) and moderate (M; 1.2 g·kg -1 ·d -1 ) protein diet while training every other day. During the High protein phase, participants consumed a 2d controlled diet prior to determining whole body phenylalanine turnover, net balance (NB), and  13 CO 2  excretion (F 13 CO 2 ) after exercise via oral [ 13 C]phenylalanine. During the Moderate phase, participants consumed 2.2 g protein·kg -1 ·d -1  for 2d prior to consuming 1.2 g protein·kg -1 ·d -1  for 5d. Phenylalanine metabolism was measured on days 1, 3, and 5 (M1, M3, and M5, respectively) of the moderate intake. F 13 CO 2 , the primary outcome for IAAO, was ~72 and ~55% greater on the 1st day (M1,  P  < 0.05) and the third day of the moderate protein diet (M3,  P  = 0.07), respectively, compared to the High protein trial. Compared to the High protein trial, NB was ~25% lower on the 1st day (M1,  P  < 0.01) and 15% lower on the third day of the moderate protein diet (M3,  P  = 0.09). High habitual protein consumption may bias protein requirements determined by traditional IAAO methods that use only a 2d pre-trial controlled diet. Post-exercise whole body anabolism is attenuated following a reduction in protein intake in resistance trained men and may require ~3-5d to adapt. This trial is registered at clinicaltrials.gov as NCT03845569.",2020,Post-exercise whole body anabolism is attenuated following a reduction in protein intake in resistance trained men and may require ~3-5d to adapt.,"['Resistance Trained Men', 'Resistance trained men [ n  = 5; 25 ± 7 y; 73.0 ± 5.7 kg; 9.9 ± 2.9% body fat; 2.69 ± 0.38 g·kg -1 ·d -1  habitual protein intake) consumed a high (H; 2.2 g·kg -1 ·d -1 ) and moderate (M; 1.2 g·kg -1 ·d -1 ) protein diet while training every other day', 'high habitual consumers']",[],"['Phenylalanine metabolism', 'IAAO']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C4517456', 'cui_str': '0.38'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0452269', 'cui_str': 'Protein diet'}, {'cui': 'C0558287', 'cui_str': 'Alternate days'}]",[],"[{'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",,0.0298941,Post-exercise whole body anabolism is attenuated following a reduction in protein intake in resistance trained men and may require ~3-5d to adapt.,"[{'ForeName': 'Cassidy T', 'Initials': 'CT', 'LastName': 'Tinline-Goodfellow', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daniel W D', 'Initials': 'DWD', 'LastName': 'West', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Malowany', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jenna B', 'Initials': 'JB', 'LastName': 'Gillen', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Moore', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.'}]",Frontiers in nutrition,['10.3389/fnut.2020.00055']
108,32391524,Improving the implementation and sustainment of evidence-based practices in community mental health organizations: a study protocol for a matched-pair cluster randomized pilot study of the Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS).,"Background


Implementing and sustaining evidence-based programs with fidelity may require multiple implementation strategies tailored to address multi-level, context-specific barriers and facilitators. Ideally, selecting and tailoring implementation strategies should be guided by theory, evidence, and input from relevant stakeholders; however, methods to guide the selection and tailoring of strategies are not well-developed. There is a need for more rigorous methods for assessing and prioritizing implementation determinants (barriers and facilitators) and linking implementation strategies to determinants. The Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS) is an intervention designed to increase the effectiveness of evidence-based practice implementation and sustainment. COAST-IS will enable organizational leaders and clinicians to use Intervention Mapping to select and tailor implementation strategies to address their site-specific needs. Intervention Mapping is a multi-step process that incorporates theory, evidence, and stakeholder perspectives to ensure that implementation strategies effectively address key determinants of change.
Methods


COAST-IS will be piloted with community mental health organizations that are working to address the needs of children and youth who experience trauma-related emotional or behavioral difficulties by engaging in a learning collaborative to implement an evidence-based psychosocial intervention (trauma-focused cognitive behavioral therapy). Organizations will be matched and then randomized to participate in the learning collaborative only (control) or to receive additional support through COAST-IS. The primary aims of this study are to (1) assess the acceptability, appropriateness, feasibility, and perceived utility of COAST-IS; (2) evaluate the organizational stakeholders' fidelity to the core elements of COAST-IS; and (3) demonstrate the feasibility of testing COAST-IS in a larger effectiveness trial.
Discussion


COAST-IS is a systematic method that integrates theory, evidence, and stakeholder perspectives to improve the effectiveness and precision of implementation strategies. If effective, COAST-IS has the potential to improve the implementation and sustainment of a wide range of evidence-based practices in mental health and other sectors.
Trial registration


This study was registered in ClinicalTrials.gov (NCT03799432) on January 10, 2019 (last updated August 5, 2019).",2020,The Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS) is an intervention designed to increase the effectiveness of evidence-based practice implementation and sustainment.,"['community mental health organizations', 'January 10, 2019 (last updated August 5, 2019']",[],[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0029237', 'cui_str': 'Organization'}]",[],[],,0.0998777,The Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS) is an intervention designed to increase the effectiveness of evidence-based practice implementation and sustainment.,"[{'ForeName': 'Byron J', 'Initials': 'BJ', 'LastName': 'Powell', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, Campus Box 1196, St. Louis, MO 63130, USA.'}, {'ForeName': 'Amber D', 'Initials': 'AD', 'LastName': 'Haley', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Sheila V', 'Initials': 'SV', 'LastName': 'Patel', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Amaya-Jackson', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Glienke', 'Affiliation': 'North Carolina Child Treatment Program, Center for Child and Family Health, Durham, NC, USA.'}, {'ForeName': 'Mellicent', 'Initials': 'M', 'LastName': 'Blythe', 'Affiliation': 'North Carolina Child Treatment Program, Center for Child and Family Health, Durham, NC, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lengnick-Hall', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, Campus Box 1196, St. Louis, MO 63130, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'McCrary', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, Campus Box 1196, St. Louis, MO 63130, USA.'}, {'ForeName': 'Rinad S', 'Initials': 'RS', 'LastName': 'Beidas', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Cara C', 'Initials': 'CC', 'LastName': 'Lewis', 'Affiliation': 'MacColl Center for Health Care Innovation, Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Aarons', 'Affiliation': 'Department of Psychiatry, Child and Adolescent Services Research Center, University of California San Diego School of Medicine, San Diego, CA, USA.'}, {'ForeName': 'Kenneth B', 'Initials': 'KB', 'LastName': 'Wells', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Saldana', 'Affiliation': 'Oregon Social Learning Center, Eugene, OR, USA.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McKay', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, Campus Box 1196, St. Louis, MO 63130, USA.'}, {'ForeName': 'Morris', 'Initials': 'M', 'LastName': 'Weinberger', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Implementation science communications,['10.1186/s43058-020-00009-5']
109,30553700,The oral splicing modifier RG7800 increases full length survival of motor neuron 2 mRNA and survival of motor neuron protein: Results from trials in healthy adults and patients with spinal muscular atrophy.,"Spinal muscular atrophy (SMA) is a rare genetic and progressively debilitating neuromuscular disease. It is the leading genetic cause of death among infants. In SMA, low levels of survival of motor neuron (SMN) protein lead to motor neuron death and muscle atrophy as the SMN protein is critical to motor neuron survival. SMA is caused by mutations in, or deletion of, the SMN1 gene. A second SMN gene, SMN2, produces only low levels of functional SMN protein due to alternative splicing which excludes exon 7 from most transcripts, generating truncated, rapidly degraded SMN protein. Patients with SMA rely on limited expression of functional SMN full-length protein from the SMN2 gene, but insufficient levels are generated. RG7800 is an oral, selective SMN2 splicing modifier designed to modulate alternative splicing of SMN2 to increase the levels of functional SMN protein. In two trials, oral administration of RG7800 increased in blood full-length SMN2 mRNA expression in healthy adults and SMN protein levels in SMA patients by up to two-fold, which is expected to provide clinical benefit.",2019,"In two trials, oral administration of RG7800 increased in blood full-length SMN2 mRNA expression in healthy adults and SMN protein levels in SMA patients by up to two-fold, which is expected to provide clinical benefit.","['Patients with SMA', 'healthy adults and patients with spinal muscular atrophy', 'healthy adults']",['RG7800'],"['full length survival of motor neuron 2 mRNA and survival of motor neuron protein', 'blood full-length SMN2 mRNA expression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]",[],"[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026609', 'cui_str': 'Motor neuron'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",,0.0192204,"In two trials, oral administration of RG7800 increased in blood full-length SMN2 mRNA expression in healthy adults and SMN protein levels in SMA patients by up to two-fold, which is expected to provide clinical benefit.","[{'ForeName': 'Heidemarie', 'Initials': 'H', 'LastName': 'Kletzl', 'Affiliation': 'Roche Innovation Center, Hoffmann-La Roche Ltd., Grenzacherstrasse 124, CH-4070 Basel, Switzerland. Electronic address: heidemarie.kletzl@roche.com.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Marquet', 'Affiliation': 'Roche Innovation Center, Hoffmann-La Roche Ltd., Grenzacherstrasse 124, CH-4070 Basel, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Günther', 'Affiliation': 'Roche Innovation Center, Hoffmann-La Roche Ltd., Grenzacherstrasse 124, CH-4070 Basel, Switzerland.'}, {'ForeName': 'Wakana', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Research, Genomics & Oncology, Roche Molecular Systems, Inc., Pleasanton, USA.'}, {'ForeName': 'Jules', 'Initials': 'J', 'LastName': 'Heuberger', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Geert Jan', 'Initials': 'GJ', 'LastName': 'Groeneveld', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Birkhoff', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Mercuri', 'Affiliation': 'Policlinico Agostino Gemelli, Rome, Italy.'}, {'ForeName': 'Hanns', 'Initials': 'H', 'LastName': 'Lochmüller', 'Affiliation': ""Medical Center-University of Freiburg, Freiburg, Germany; Center for Genomic Regulation, Barcelona Institute of Science and Technology (BIST), Barcelona, Spain; John Walton Muscular Dystrophy Research Centre, Newcastle University, Newcastle upon Tyne, UK; Children's Hospital of Eastern Ontario Research Institute, University of Ottawa, Ottawa, Canada and Division of Neurology, Department of Medicine, The Ottawa Hospital, Ottawa, Canada.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Wood', 'Affiliation': 'John Walton Muscular Dystrophy Research Centre, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Fischer', 'Affiliation': 'Universitäts-Kinderspital beider Basel, Basel, Switzerland; University Clinic of Internal Medicine, Kantonsspital Baselland, Bruderholz, Switzerland.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Gerlach', 'Affiliation': 'Roche Innovation Center, Hoffmann-La Roche Ltd., Grenzacherstrasse 124, CH-4070 Basel, Switzerland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Heinig', 'Affiliation': 'Roche Innovation Center, Hoffmann-La Roche Ltd., Grenzacherstrasse 124, CH-4070 Basel, Switzerland.'}, {'ForeName': 'Teodorica', 'Initials': 'T', 'LastName': 'Bugawan', 'Affiliation': 'Research, Genomics & Oncology, Roche Molecular Systems, Inc., Pleasanton, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Dziadek', 'Affiliation': 'Roche Innovation Center, Hoffmann-La Roche Ltd., Grenzacherstrasse 124, CH-4070 Basel, Switzerland.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Kinch', 'Affiliation': 'Roche Innovation Center, Hoffmann-La Roche Ltd., Welwyn, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Czech', 'Affiliation': 'Roche Innovation Center, Hoffmann-La Roche Ltd., Grenzacherstrasse 124, CH-4070 Basel, Switzerland.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Khwaja', 'Affiliation': 'Roche Innovation Center, Hoffmann-La Roche Ltd., Grenzacherstrasse 124, CH-4070 Basel, Switzerland.'}]",Neuromuscular disorders : NMD,['10.1016/j.nmd.2018.10.001']
110,32395440,Effects of Chromium Picolinate Supplementation on Cardiometabolic Biomarkers in Patients with Type 2 Diabetes Mellitus: a Randomized Clinical Trial.,"Type 2 diabetes mellitus (T2DM) is a serious public health problem accompanies with several complications. This study was conducted to evaluate the effects of chromium picolinate (CrPic) supplementation on the glycemic status and lipid profile in patients with T2DM. The patients with T2DM (n = 52) were randomly allocated into 2 groups. One group received 400 µg CrPic per day and the other group took placebo; the intervention duration was 8 weeks. Anthropometric indices and metabolic factors were measured at the beginning, and at end of the study. The patients were recommended not to change their normal diet, life style and medication. No significant changes were observed for weight, body mass index, and fasting blood glucose (FBG) in both groups; while intra-groups changes in homeostatic model assessment for insulin resistance (HOMA-IR) value was significant (p < 0.05). Results of analysis of covariance showed that there were significance differences between groups in total cholesterol, low density lipoprotein cholesterol and HOMA-IR at the end of the intervention adjusting for baseline levels (p = 0.035, 0.030 and < 0.001, respectively). In this study, oral supplementation with 400 µg CrPic for eight weeks did not alter FBG concentration as well as anthropometric parameters in individuals with T2DM. However, the modest beneficial effects of chromium supplementation on insulin resistance as indicated by HOMA-IR and lipid profile were found.",2020,"No significant changes were observed for weight, body mass index, and fasting blood glucose (FBG) in both groups; while intra-groups changes in homeostatic model assessment for insulin resistance (HOMA-IR) value was significant (p < 0.05).","['patients with T2DM (n = 52', 'Type 2 diabetes mellitus (T2DM', 'individuals with T2DM', 'Patients with Type 2 Diabetes Mellitus', 'patients with T2DM']","['chromium supplementation', '400 µg CrPic per day and the other group took placebo', 'chromium picolinate (CrPic) supplementation', 'Chromium Picolinate Supplementation']","['total cholesterol, low density lipoprotein cholesterol and HOMA-IR', 'insulin resistance', 'Anthropometric indices and metabolic factors', 'HOMA-IR and lipid profile', 'FBG concentration', 'glycemic status and lipid profile', 'Cardiometabolic Biomarkers', 'homeostatic model assessment for insulin resistance (HOMA-IR) value', 'weight, body mass index, and fasting blood glucose (FBG']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0163657', 'cui_str': 'CHROMIUM PICOLINATE'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",52.0,0.0250518,"No significant changes were observed for weight, body mass index, and fasting blood glucose (FBG) in both groups; while intra-groups changes in homeostatic model assessment for insulin resistance (HOMA-IR) value was significant (p < 0.05).","[{'ForeName': 'Aria Tavakoli', 'Initials': 'AT', 'LastName': 'Talab', 'Affiliation': ""Be'sat Hospital, Hamadan University of Medical Sciences, Hamadan 6517838678, Iran.""}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Abdollahzad', 'Affiliation': 'Department of Nutrition, Research Center for Environmental Determinants of Health, Health Institute, Kermanshah University of Medical Sciences, Kermanshah 6719851351, Iran.'}, {'ForeName': 'Seyyed Mustafa', 'Initials': 'SM', 'LastName': 'Nachvak', 'Affiliation': 'Department of Nutrition, Research Center for Environmental Determinants of Health, Health Institute, Kermanshah University of Medical Sciences, Kermanshah 6719851351, Iran.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Pasdar', 'Affiliation': 'Department of Nutrition, Research Center for Environmental Determinants of Health, Health Institute, Kermanshah University of Medical Sciences, Kermanshah 6719851351, Iran.'}, {'ForeName': 'Shahryar', 'Initials': 'S', 'LastName': 'Eghtesadi', 'Affiliation': 'Islamic Azad University; Tehran Medical Branch and Science & Research Branch, Tehran 1477983855, Iran.'}, {'ForeName': 'Azimeh', 'Initials': 'A', 'LastName': 'Izadi', 'Affiliation': ""Students' Research Committee, Faculty of Nutrition, Tabriz University of Medical Sciences, Tabriz 5166614711, Iran.""}, {'ForeName': 'Mir Amir', 'Initials': 'MA', 'LastName': 'Aghdashi', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Urmia University of Medical Sciences, Urmia 5714783734, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Mohammad Hossseini Azar', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Urmia University of Medical Sciences, Urmia 5714783734, Iran.'}, {'ForeName': 'Sedighe', 'Initials': 'S', 'LastName': 'Moradi', 'Affiliation': 'Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences, Tehran 1593716615, Iran.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Mehaki', 'Affiliation': 'Department of Biostatistics, Research Center for Environmental Determinants of Health, Health Institute, Kermanshah University of Medical Sciences, Kermanshah 6715847141, Iran.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Moradi', 'Affiliation': 'Department of Nutrition, Research Center for Environmental Determinants of Health, Health Institute, Kermanshah University of Medical Sciences, Kermanshah 6719851351, Iran.'}]",Clinical nutrition research,['10.7762/cnr.2020.9.2.97']
111,32395474,The effect of RAS blockers on the clinical characteristics of COVID-19 patients with hypertension.,"Background


Coronavirus disease 2019 (COVID-19), caused by a novel coronavirus (designated as SARS-CoV-2) has become a pandemic worldwide. Based on the current reports, hypertension may be associated with increased risk of sever condition in hospitalized COVID-19 patients. Angiotensin-converting enzyme 2 (ACE2) was recently identified to functional receptor of SARS-CoV-2. Previous experimental data revealed ACE2 level was increased following treatment with ACE inhibitors (ACEIs) and angiotensin receptor blockers (ARBs). Currently doctors concern whether these commonly used renin-angiotensin system (RAS) blockers-ACEIs/ARBs may increase the severity of COVID-19.
Methods


We extracted data regarding 50 hospitalized hypertension patients with laboratory confirmed COVID-19 in the Renmin Hospital of Wuhan University from Feb 7 to Mar 03, 2020. These patients were grouped into RAS blockers group (Group A, n=20) and non-RAS blockers group (Group B, n=30) according to the basic blood pressure medications. All patients continued to use pre-admission antihypertensive drugs. Clinical severity (symptoms, laboratory and chest CT findings, etc.), clinical course, and short time outcome were analyzed after hospital admission.
Results


Ten (50%) and seventeen (56.7%) of the Group A and Group B participants were males (P=0.643), and the average age was 52.65±13.12 and 67.77±12.84 years (P=0.000), respectively. The blood pressure of both groups was under effective control. There was no significant difference in clinical severity, clinical course and in-hospital mortality between Group A and Group B. Serum cardiac troponin I (cTnI) (P=0.03), and N-terminal (NT)-pro hormone BNP (NT-proBNP) (P=0.04) showed significant lower level in Group A than in Group B. But the patients with more than 0.04ng/mL or elevated NT-proBNP level had no statistical significance between the two groups. In patients over 65 years or under 65 years, cTnI or NT-proBNP level showed no difference between the two groups.
Conclusions


We observed there was no obvious difference in clinical characteristics between RAS blockers and non-RAS blockers groups. These data suggest ACEIs/ARBs may have few effects on increasing the clinical severe conditions of COVID-19.",2020,"In patients over 65 years or under 65 years, cTnI or NT-proBNP level showed no difference between the two groups.
","['COVID-19 patients with hypertension', '50 hospitalized hypertension patients with laboratory confirmed COVID-19 in the Renmin Hospital of Wuhan University from Feb 7 to Mar 03, 2020', 'hospitalized COVID-19 patients']","['non-RAS blockers', 'RAS blockers', 'Angiotensin-converting enzyme 2 (ACE2']","['Clinical severity (symptoms, laboratory and chest CT findings, etc.), clinical course, and short time outcome', 'blood pressure', 'elevated NT-proBNP level', 'cTnI or NT-proBNP level', 'clinical severity, clinical course and in-hospital mortality', 'ACE2 level', 'Serum cardiac troponin I (cTnI) (P=0.03), and N-terminal (NT)-pro hormone BNP (NT-proBNP']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0024782', 'cui_str': 'Marathi language'}]","[{'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0449259', 'cui_str': 'Clinical course'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}]",,0.0317682,"In patients over 65 years or under 65 years, cTnI or NT-proBNP level showed no difference between the two groups.
","[{'ForeName': 'Zheyong', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Jiatian', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Yumeng', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Department of Infection Disease, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Xuejuan', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Luo', 'Affiliation': 'Department of Critical Medicine, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Department of Critical Medicine, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Chouwen', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Gastroenterology, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Yunzeng', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Juying', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Kaihuan', 'Initials': 'K', 'LastName': 'Yu', 'Affiliation': 'Department of Hepatobiliary Surgery, Renmin Hospital of Wuhan University, Wuhan 430200, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Gong', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}]",Annals of translational medicine,['10.21037/atm.2020.03.229']
112,32395481,TRIB3  rs6037475 is a potential biomarker for predicting felodipine drug response in Chinese patients with hypertension.,"Background


Our previous studies have found that single nucleotide polymorphisms (SNPs) of  tribbles homolog 3  ( TRIB3 ) are related to the hypotensive effects of calcium-channel blockers (CCBs) and angiotensin-converting enzyme (ACE) inhibitors. In this study, we aimed at exploring and validating the effect of  TRIB3  polymorphism on antihypertensive drugs responses.
Methods


A total of 830 hypertensive patients, who were administered with open-labeled hydrochlorothiazide (12.5 mg once daily) and randomly assigned to off-labeled felodipine (5 mg) or a matched placebo combination treatment (1:1), were selected from the Felodipine Event Reduction (FEVER) study. A strategy of screening 259 samples and validating the remaining 531 samples was implemented. Four functional SNPs were selected (rs2295490, rs11470129, rs4815567 and rs6037475 in  TRIB3 ). A mixed linear model was performed to analyze the effects of  TRIB3  SNPs on antihypertensive drugs responses.
Results


We found that  TRIB3  rs6037475 CC genotype was associated with a reduction of diastolic blood pressure (DBP) (P=6.3×10 -3 ) in the felodipine treatment group of screening set, and was also associated with a reduction of systolic blood pressure (SBP) (P=0.021), DBP (P=6.0×10 -3 ) and mean arterial pressure (MAP) (P=0.021) in the felodipine treatment group of the validation set. As for the reductions influenced by the rs2295490, rs11470129 and rs4815567 genetic variations, however, the adjusted P-value did not reach statistical significance. Combined screening and validation set analysis found that patients with  TRIB3  rs6037475 CC genotype had a significant higher mean SBP, DBP and MAP than those with TT genotype in the felodipine treatment group (CC  vs . TT -10.2±0.74  vs . -17.8±0.21, P=7.8×10 -3 ; -4.6±0.50  vs . -10.2±0.23, P=3.0×10 -4 ; -6.5±0.54  vs.  -12.7±0.14, P=3.0×10 -4 , respectively).
Conclusions


These results suggest that  TRIB3  rs6037475 genetic variation can be useful as a bio-marker for predicting felodipine drug response in Chinese patients with hypertension.",2020,"Combined screening and validation set analysis found that patients with  TRIB3  rs6037475 CC genotype had a significant higher mean SBP, DBP and MAP than those with TT genotype in the felodipine treatment group (CC  vs .","['Chinese patients with hypertension', '830 hypertensive patients']","['Felodipine', 'labeled felodipine', 'open-labeled hydrochlorothiazide', 'placebo combination treatment', 'felodipine']","['mean arterial pressure (MAP', 'mean SBP, DBP and MAP', 'DBP', 'systolic blood pressure (SBP', 'diastolic blood pressure (DBP']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4517889', 'cui_str': '830'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0015772', 'cui_str': 'Felodipine'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",830.0,0.0196581,"Combined screening and validation set analysis found that patients with  TRIB3  rs6037475 CC genotype had a significant higher mean SBP, DBP and MAP than those with TT genotype in the felodipine treatment group (CC  vs .","[{'ForeName': 'Fazhong', 'Initials': 'F', 'LastName': 'He', 'Affiliation': ""Zhuhai People's Hospital (Zhuhai hospital affiliated with Jinan University), Zhuhai 519000, China.""}, {'ForeName': 'Bao', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': 'Department of Clinical Pharmacology, Xiangya Hospital, Central South University, Changsha 410078, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai 519000, China.'}, {'ForeName': 'Mouze', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical Pharmacology, Xiangya Hospital, Central South University, Changsha 410078, China.'}, {'ForeName': 'Weijie', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': ""Zhuhai People's Hospital (Zhuhai hospital affiliated with Jinan University), Zhuhai 519000, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Zhuhai People's Hospital (Zhuhai hospital affiliated with Jinan University), Zhuhai 519000, China.""}, {'ForeName': 'Yinxiang', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Zhuhai People's Hospital (Zhuhai hospital affiliated with Jinan University), Zhuhai 519000, China.""}, {'ForeName': 'Yuhong', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': ""Zhuhai People's Hospital (Zhuhai hospital affiliated with Jinan University), Zhuhai 519000, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department II of Thoracic Medicine, Hunan Cancer Hospital, Changsha 519000, China.'}, {'ForeName': 'Ligong', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': ""Zhuhai People's Hospital (Zhuhai hospital affiliated with Jinan University), Zhuhai 519000, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Pharmacology, Xiangya Hospital, Central South University, Changsha 410078, China.'}, {'ForeName': 'Zhiling', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""Zhuhai People's Hospital (Zhuhai hospital affiliated with Jinan University), Zhuhai 519000, China.""}]",Annals of translational medicine,['10.21037/atm.2020.03.176']
113,32395501,Statistical analysis plan for aggressive hydraTion in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention to prevenT contrast-induced nephropathy (ATTEMPT) study.,"Background


The ATTEMPT study is a multicenter, randomized controlled trial which is investigator-based and open label in nature. For the study, 560 patients with ST-segment elevation myocardial infarction (STEMI) underwent primary percutaneous coronary intervention (pPCI) have been randomized (1:1) for treatment with periprocedural aggressive hydration (treatment group) or general hydration (control group). To improve the quality of the study's analysis and to minimize analysis bias based on the study's findings.
Methods


The design of the statistical analysis plan (SAP) was created by chief investigators and statisticians and received permission from the aggressive hydraTion in patients with ST-Elevation Myocardial infarction undergoing Primary percutaneous coronary intervention to prevenT contrast-induced nephropathy (ATTEMPT) management committee. Treatment allocation and research data were reviewed by the Data Safety and Monitoring Committee and researchers were kept blind. We produced data shells based on a pre-existing published protocol and produced detailed descriptions of statistical analyses. This study includes primary, secondary and safety endpoints. Relevant statistical comparisons were planned and discussed in a transparent manner. They are publicly available, verifiable and were determined prior to the data collection process being completed.
Results


We developed a SAP for the ATTEMPT study and an outline and list of mock tables were also created. We produced descriptions of analyses of baseline characteristics, patient care approaches, efficacy measures, and outcomes. This study defined five previously specified subgroups and compared the statistics of groups within these subgroups.
Conclusions


This SAP has been developed for the ATTEMPT study and has high-quality standards of internal validity to minimize analysis bias.
Trial registration


ClinicalTrials.gov number, NCT02067195.",2020,"For the study, 560 patients with ST-segment elevation myocardial infarction (STEMI) underwent primary percutaneous coronary intervention (pPCI) have been randomized (1:1) for treatment with periprocedural aggressive hydration (treatment group) or general hydration (control group).","['patients with ST-Elevation Myocardial infarction undergoing Primary', '560 patients with ST-segment elevation myocardial infarction (STEMI) underwent primary', 'patients with ST-elevation myocardial infarction undergoing primary']","['periprocedural aggressive hydration (treatment group) or general hydration (control group', 'percutaneous coronary intervention to prevenT contrast-induced nephropathy', 'percutaneous coronary intervention', 'percutaneous coronary intervention (pPCI']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",[],560.0,0.0803154,"For the study, 560 patients with ST-segment elevation myocardial infarction (STEMI) underwent primary percutaneous coronary intervention (pPCI) have been randomized (1:1) for treatment with periprocedural aggressive hydration (treatment group) or general hydration (control group).","[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Provincial Key Laboratory of Coronary Heart Disease, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou 510100, China.""}, {'ForeName': 'Zhaodong', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': ""Department of Cardiology, Provincial Key Laboratory of Coronary Heart Disease, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou 510100, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Lei', 'Affiliation': 'The Second School of Clinical Medicine, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'Guoli', 'Initials': 'G', 'LastName': 'Sun', 'Affiliation': ""Department of Cardiology, Provincial Key Laboratory of Coronary Heart Disease, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou 510100, China.""}, {'ForeName': 'Yibo', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': ""Department of Cardiology, Provincial Key Laboratory of Coronary Heart Disease, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou 510100, China.""}, {'ForeName': 'Feier', 'Initials': 'F', 'LastName': 'Song', 'Affiliation': ""Department of Emergency and Critical Care Medicine, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou 510080, China.""}, {'ForeName': 'Jiyan', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Provincial Key Laboratory of Coronary Heart Disease, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou 510100, China.""}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Tan', 'Affiliation': ""Department of Cardiology, Provincial Key Laboratory of Coronary Heart Disease, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou 510100, China.""}, {'ForeName': 'Shiqun', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Provincial Key Laboratory of Coronary Heart Disease, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou 510100, China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Provincial Key Laboratory of Coronary Heart Disease, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou 510100, China.""}]",Annals of translational medicine,['10.21037/atm.2020.03.192']
114,32395686,Gastroscopy Should Come Before Colonoscopy Using CO 2  Insufflation in Same Day Bidirectional Endoscopies: A Randomized Controlled Trial.,"Background and Aims


Same day bidirectional endoscopies (esophagogastroduodenoscopies [EGD]s and colonoscopies) are routinely performed. However, the best sequence of procedures is unknown, as is whether the use of carbon dioxide (CO 2 ) affects the preferred sequence of procedures. This study aims to determine the preferred sequence of procedures and choice of insufflation gas (air or CO 2 ) in patients undergoing same day bidirectional endoscopies.
Methods


Two hundred adults with a clinical indication for same day bidirectional endoscopies were randomized equally into four groups: A1 (EGD first, CO 2  as insufflator); A2 (EGD first, air as insufflator); B1 (colonoscopy first, CO 2  as insufflator); and B2 (colonoscopy first, air as insufflator). All procedures were performed with conscious sedation (Midazolam/Fentanyl). The primary outcome was patients' overall comfort/satisfaction with the procedures and sedation received, as assessed by questionnaires and validated scoring scales (Nurse-Assessed Patient Comfort Score [NAPCOMS], La Crosse [WI]) collected during the procedures, before discharge, and on day 7 postprocedure.
Results


Two hundred patients were randomized, with data available for 186. Mean Midazolam dose between groups was significantly less in the EGD first groups ( P =0.01). During the procedures, no differences were found in patients' comfort as per the nurse reported NAPCOMS scores ( P =0.19) or the Lacrosse (WI) endoscopy scores ( P =0.05). On postprocedure days 0 and 7, no differences were found in the patients' reported Lacrosse (WI) scores, nausea, sore throat, dizziness, satisfaction with sedation or overall level of procedural satisfaction ( P >0.05 for each). However, bloating and discomfort were significantly lower in the CO 2  arms ( P <0.001).
Conclusions


This randomized controlled trial using validated patient comfort scoring assessments for same day bidirectional endoscopies demonstrated that the sequence of procedures affects the sedation used but does not affect overall patient comfort or satisfaction. Lesser sedation is needed in the EGD first group, and less postprocedural abdominal pain/discomfort and bloating is seen with CO 2  insufflation.",2020,Mean Midazolam dose between groups was significantly less in the EGD first groups ( P =0.01).,"['patients undergoing same day bidirectional endoscopies', 'Two hundred adults with a clinical indication for same day bidirectional endoscopies', 'Two hundred patients were randomized, with data available for 186']","['conscious sedation (Midazolam/Fentanyl', 'insufflation gas (air or CO 2 ', 'A1 (EGD first, CO 2  as insufflator); A2 (EGD first, air as insufflator); B1 (colonoscopy first, CO 2  as insufflator); and B2 (colonoscopy first, air as insufflator']","['postprocedural abdominal pain/discomfort and bloating', 'Lacrosse (WI) scores, nausea, sore throat, dizziness, satisfaction with sedation or overall level of procedural satisfaction', 'overall comfort/satisfaction with the procedures and sedation received, as assessed by questionnaires and validated scoring scales (Nurse-Assessed Patient Comfort Score [NAPCOMS], La Crosse [WI', 'Lacrosse (WI) endoscopy scores', 'overall patient comfort or satisfaction', 'bloating and discomfort', 'NAPCOMS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C0021639', 'cui_str': 'Insufflator'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0022909', 'cui_str': 'Lacrosse'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]",200.0,0.0535872,Mean Midazolam dose between groups was significantly less in the EGD first groups ( P =0.01).,"[{'ForeName': 'Fahd', 'Initials': 'F', 'LastName': 'Jowhari', 'Affiliation': ""Gastrointestinal Diseases Research Unit, Department of Medicine, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Hookey', 'Affiliation': ""Gastrointestinal Diseases Research Unit, Department of Medicine, Queen's University, Kingston, Ontario, Canada.""}]",Journal of the Canadian Association of Gastroenterology,['10.1093/jcag/gwy074']
115,30697471,Impact of Financial Incentives on Health Outcomes and Costs of Care among Medicaid Beneficiaries with Diabetes in Hawai'i.,"The Hawai'i Patient Reward And Incentives to Support Empowerment (HI-PRAISE) project, part of the Medicaid Incentives for Prevention of Chronic Diseases program of the Affordable Care Act, examined the impact of financial incentives on Medicaid beneficiaries with diabetes. It included an observational pre-post study which was conducted at nine Federally Qualified Health Centers (FQHCs) between 2013 to 2015. The observational study enrolled 2,003 participants. Participants could earn up to $320/year in financial incentives. Primary outcomes were change in hemoglobin A1c, blood pressure, and cholesterol; secondary outcomes included compliance with American Diabetes Association (ADA) standards of diabetes care and cost effectiveness. Generalized estimating equation models were used to assess differences in clinical outcomes and general linear models were utilized to estimate the medical costs per patient/day. Changes in clinical outcomes in the observational study were statistically significant: mean hemoglobin A1c decreased from 8.56% to 8.24% ( P  < .0001); mean systolic blood pressure decreased from 125.16 to 124.18 mm Hg ( P  = .0137); mean diastolic blood pressure decreased from 75.54 to 74.78 mm Hg ( P  = .0005); total cholesterol decreased from 180.77 to 174.21 mg/dl ( P  < .0001); and low-density lipoprotein decreased from 106.17 to 98.55 mg/dl ( P  < .0001). Improved ADA compliance was also observed. A key limitation was a reduced sample size due to participant's fluctuating Medicaid eligibility status. HI-PRAISE showed no reduction in total health cost during the project period.",2019,Changes in clinical outcomes in the observational study were statistically significant: mean hemoglobin A1c decreased from 8.56% to 8.24% ( P  < .0001); mean systolic blood pressure decreased from 125.16 to 124.18 mm Hg ( P  = .0137); mean diastolic blood pressure decreased from 75.54 to 74.78 mm Hg ( P  = .0005); total cholesterol decreased from 180.77 to 174.21 mg/dl ( P  < .0001); and low-density lipoprotein decreased from 106.17 to 98.55 mg/dl ( P  < .0001).,"['nine Federally Qualified Health Centers (FQHCs) between 2013 to 2015', 'Medicaid beneficiaries with diabetes', ""Medicaid Beneficiaries with Diabetes in Hawai'i"", '2,003 participants']",['Financial Incentives'],"['mean systolic blood pressure', 'total cholesterol', 'low-density lipoprotein', 'Health Outcomes and Costs of Care', 'change in hemoglobin A1c, blood pressure, and cholesterol; secondary outcomes included compliance with American Diabetes Association (ADA) standards of diabetes care and cost effectiveness', 'Improved ADA compliance', 'mean diastolic blood pressure', 'total health cost', 'mean hemoglobin A1c']","[{'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0018619', 'cui_str': 'Hawaii state'}]","[{'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}]",2003.0,0.0265985,Changes in clinical outcomes in the observational study were statistically significant: mean hemoglobin A1c decreased from 8.56% to 8.24% ( P  < .0001); mean systolic blood pressure decreased from 125.16 to 124.18 mm Hg ( P  = .0137); mean diastolic blood pressure decreased from 75.54 to 74.78 mm Hg ( P  = .0005); total cholesterol decreased from 180.77 to 174.21 mg/dl ( P  < .0001); and low-density lipoprotein decreased from 106.17 to 98.55 mg/dl ( P  < .0001).,"[{'ForeName': 'Ritabelle', 'Initials': 'R', 'LastName': 'Fernandes', 'Affiliation': ""Department of Geriatric Medicine, John A. Burns School of Medicine, University of Hawai'i at Manoa, Honolulu, HI (RF).""}, {'ForeName': 'Chuan C', 'Initials': 'CC', 'LastName': 'Chinn', 'Affiliation': ""Center on Disability Studies, University of Hawai'i at Manoa, Honolulu, HI (CCC, RRO).""}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, NY (DL).'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Halliday', 'Affiliation': ""Department of Economics, University of Hawai'i at Manoa, Honolulu, HI (TH).""}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Frankland', 'Affiliation': ""Kaiser Permanente, Center for Health Research Hawai'i, Honolulu, HI (TF).""}, {'ForeName': 'Rebecca Rude', 'Initials': 'RR', 'LastName': 'Ozaki', 'Affiliation': ""Center on Disability Studies, University of Hawai'i at Manoa, Honolulu, HI (CCC, RRO).""}]",Hawai'i journal of medicine & public health : a journal of Asia Pacific Medicine & Public Health,[]
116,31201110,Radiotherapy Quality Assurance for the CHHiP Trial: Conventional Versus Hypofractionated High-Dose Intensity-Modulated Radiotherapy in Prostate Cancer.,"AIMS


The CHHiP trial investigated the use of moderate hypofractionation for the treatment of localised prostate cancer using intensity-modulated radiotherapy (IMRT). A radiotherapy quality assurance programme was developed to assess compliance with treatment protocol and to audit treatment planning and dosimetry of IMRT. This paper considers the outcome and effectiveness of the programme.
MATERIALS AND METHODS


Quality assurance exercises included a pre-trial process document and planning benchmark cases, prospective case reviews and a dosimetry site visit on-trial and a post-trial feedback questionnaire.
RESULTS


In total, 41 centres completed the quality assurance programme (37 UK, four international) between 2005 and 2010. Centres used either forward-planned (field-in-field single phase) or inverse-planned IMRT (25 versus 17). For pre-trial quality assurance exercises, 7/41 (17%) centres had minor deviations in their radiotherapy processes; 45/82 (55%) benchmark plans had minor variations and 17/82 (21%) had major variations. One hundred prospective case reviews were completed for 38 centres. Seventy-one per cent required changes to clinical outlining pre-treatment (primarily prostate apex and base, seminal vesicles and penile bulb). Errors in treatment planning were reduced relative to pre-trial quality assurance results (49% minor and 6% major variations). Dosimetry audits were conducted for 32 centres. Ion chamber dose point measurements were within ±2.5% in the planning target volume and ±8% in the rectum. 28/36 films for combined fields passed gamma criterion 3%/3 mm and 11/15 of IMRT fluence film sets passed gamma criterion 4%/4 mm using a 98% tolerance. Post-trial feedback showed that trial participation was beneficial in evolving clinical practice and that the quality assurance programme helped some centres to implement and audit prostate IMRT.
CONCLUSION


Overall, quality assurance results were satisfactory and the CHHiP quality assurance programme contributed to the success of the trial by auditing radiotherapy treatment planning and protocol compliance. Quality assurance supported the introduction of IMRT in UK centres, giving additional confidence and external review of IMRT where it was a newly adopted technique.",2019,Errors in treatment planning were reduced relative to pre-trial quality assurance results (49% minor and 6% major variations).,"['Prostate Cancer', 'One hundred prospective case reviews were completed for 38 centres']","['Hypofractionated High-Dose Intensity-Modulated Radiotherapy', 'forward-planned (field-in-field single phase) or inverse-planned IMRT', 'intensity-modulated radiotherapy (IMRT']","['quality assurance programme', 'Radiotherapy Quality Assurance']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439850', 'cui_str': 'Inverse'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]",,0.0904612,Errors in treatment planning were reduced relative to pre-trial quality assurance results (49% minor and 6% major variations).,"[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Naismith', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, UK. Electronic address: Olivia.naismith@rmh.nhs.uk.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Mayles', 'Affiliation': 'Clatterbridge Cancer Centre, Bebington, Wirral, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bidmead', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Clark', 'Affiliation': 'Royal Surrey County Hospital, Guildford, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gulliford', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hassan', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Khoo', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, UK; The Institute of Cancer Research, London, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Roberts', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'South', 'Affiliation': 'Royal Surrey County Hospital, Guildford, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dearnaley', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, UK; The Institute of Cancer Research, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical oncology (Royal College of Radiologists (Great Britain)),['10.1016/j.clon.2019.05.009']
117,32406224,The recovery of reaching movement in breast cancer survivors: two different rehabilitative protocols in comparison.,"BACKGROUND


Breast-cancer (BC) is the most common cancer in women in the developed world. The about the sequelae of surgery, especially in case of mastectomy or modified radical mastectomy is grown. Nowadays it's important choose appropriate exercise-programs to allow recovery in ""quantity"" but also in ""quality"" ""of the movement of the operated upper-limb.
AIM


The aim of this study was to verify whether specific exercises for the scapula may induce changes in fluidity of the reaching movement.
DESIGN


Randomized control-trial double-blind study.
SETTING


Exercise training laboratory and Gait Analysis laboratory.
POPULATION


Sixty-three breast cancer survivors were enrolled.
METHODS


Participants randomized to Single Rehabilitative Treatment (ST), or to Group Rehabilitative Treatment (GT). VAS, DASH and a biomechanical-evaluation of upper limb were performed for each group before treatment (T0=baseline), at the end rehabilitative treatment (T1) and after three months of follow-up (T2).
RESULTS


Respect within group analysis, in the ST and in the GT, for VAS an improvement along evaluation times were observed, respectively at T0 to T1 and at T0 to T2 (p<0,001) without a statistically significant difference between groups. At the same, for the DASH, the results showed the same trend without a statistically significant difference between groups. For biomechanics parameters, at T2 velocity was statistically significantly greater in the ST than in the GT (p=0.029) in contrast with the duration, that was statistically significantly greater in the GT than in the ST (p=0.010).
CONCLUSIONS


Both protocols are effective in reducing pain and for functional recovery of the upperlimb. The adoption of a non-intensive rehabilitation program should be implemented at least in the first year after the operation, with the adoption of specific myofascial exercises on the scapulothoracic joint with better results in the ""qualitative"" recovery of the achievement.
CLINICAL REHABILITATION IMPACT


Our study emphasizes the importance of rehabilitation in BC survivors after mastectomy, even during the course of radiotherapy and chemotherapy and the adoption of specific myofascial exercises on the scapulo-thoracic joint and specific exercises of muscular stretching on the pectoral muscle. Therefore, the proposed rehabilitation protocol must be ""clipped"" and ""integrated"" according to the specific objectives for each individual patient.",2020,"For biomechanics parameters, at T2 velocity was statistically significantly greater in the ST than in the GT (p=0.029) in contrast with the duration, that was statistically significantly greater in the GT than in the ST (p=0.010).
","['breast cancer survivors', 'Sixty-three breast cancer survivors were enrolled']","['radiotherapy and chemotherapy', 'Single Rehabilitative Treatment (ST), or to Group Rehabilitative Treatment (GT', 'specific myofascial exercises', 'specific exercises']","['T2 velocity', 'VAS, DASH and a biomechanical-evaluation of upper limb', 'pain']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4319614', 'cui_str': '63'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",63.0,0.0301914,"For biomechanics parameters, at T2 velocity was statistically significantly greater in the ST than in the GT (p=0.029) in contrast with the duration, that was statistically significantly greater in the GT than in the ST (p=0.010).
","[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Paolucci', 'Affiliation': ""Department of Medical, Oral and Biotechnological Sciences, G. D'Annunzio University of Chieti-Pescara, Chieti, Italy.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bernetti', 'Affiliation': 'Department of Anatomical and Histological Sciences, Legal Medicine and Orthopedics, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Arianna V', 'Initials': 'AV', 'LastName': 'Bai', 'Affiliation': 'Department of Anatomical and Histological Sciences, Legal Medicine and Orthopedics, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Serena V', 'Initials': 'SV', 'LastName': 'Capobianco', 'Affiliation': 'Department of Anatomical and Histological Sciences, Legal Medicine and Orthopedics, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Bonifacino', 'Affiliation': ""Breast Diagnosis and Treatment Unit, Sant'Andrea Hospital, Rome Italy.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Maggi', 'Affiliation': 'University Hospital Umberto I of Rome, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Ippolitoni', 'Affiliation': 'University Hospital Umberto I of Rome, Rome, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tinelli', 'Affiliation': 'University Hospital Umberto I of Rome, Rome, Italy.'}, {'ForeName': 'Valter', 'Initials': 'V', 'LastName': 'Santilli', 'Affiliation': 'Department of Anatomical and Histological Sciences, Legal Medicine and Orthopedics, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Agostini', 'Affiliation': 'Department of Anatomical and Histological Sciences, Legal Medicine and Orthopedics, Sapienza University of Rome, Rome, Italy - francescoagostini.ff@gmail.com.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Paoloni', 'Affiliation': 'Department of Anatomical and Histological Sciences, Legal Medicine and Orthopedics, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Mangone', 'Affiliation': 'Department of Anatomical and Histological Sciences, Legal Medicine and Orthopedics, Sapienza University of Rome, Rome, Italy.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.20.06138-9']
118,32406265,Peer Relations and Delinquency Among Girls in Foster Care Following a Skill-Building Preventive Intervention.,"There is evidence that risk for delinquency is elevated among girls with foster care histories, and one correlate of delinquency is affiliating with peers who engage in delinquent behavior. Although intervention studies have shown positive effects of interventions that target delinquent peer affiliation on reductions in delinquency among adolescents with juvenile justice histories, the success of such interventions for younger girls in foster care, without prior involvement with juvenile justice, is unknown. We analyzed data from a randomized clinical trial of the middle school version of the Keep Safe intervention in a sample of girls in foster care ( n  = 100). The intervention was delivered to girls and foster parents during the transition to middle school. Path analysis suggested a significant intervention effect on reduction in affiliation with delinquent peers at 12 months ( B  = -.21). No significant mediation effects were identified. The middle school Keep Safe intervention shows promise as a preventative intervention for reducing affiliation with delinquent peers, which importantly is associated with adolescent delinquent behavior. Implications for researchers and professionals who tailor and deliver evidence-based programs for girls in foster care are discussed.",2020,"The middle school Keep Safe intervention shows promise as a preventative intervention for reducing affiliation with delinquent peers, which importantly is associated with adolescent delinquent behavior.","['adolescents with juvenile justice histories', 'Girls in Foster Care', 'girls with foster care histories', 'sample of girls in foster care ( n  = 100']",['middle school version of the Keep Safe intervention'],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3146221', 'cui_str': 'Juvenile'}, {'cui': 'C0022437', 'cui_str': 'Justice'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0599066,"The middle school Keep Safe intervention shows promise as a preventative intervention for reducing affiliation with delinquent peers, which importantly is associated with adolescent delinquent behavior.","[{'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Hu', 'Affiliation': 'University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Van Ryzin', 'Affiliation': 'University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Schweer-Collins', 'Affiliation': 'University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Leslie D', 'Initials': 'LD', 'LastName': 'Leve', 'Affiliation': 'University of Oregon, Eugene, OR, USA.'}]",Child maltreatment,['10.1177/1077559520923033']
119,32406284,Prophylaxis of Radiation-Induced Dermatitis in Patients With Breast Cancer Using Herbal Creams: A Prospective Randomized Controlled Trial.,"Radiation-induced toxicity is a major limiting factor for prescribing radiation dose in cancer radiotherapy. Skin reaction to radiation is one of the primary concerns, which could affect quality of life of the patients both physically and mentally. Reviews of the literature show limited number of effective reagents for its prophylaxis. In this study, we attempted to determine whether prophylactic treatment of the 3 different herbal creams containing  Centella asiatica ,  Cucumis sativus , and  Thunbergia laurifolia  extracts as well as a commercial moisturizing cream could reduce acute skin reaction in breast cancer patients undergoing radiotherapy. A total of 153 breast cancer patients undergoing radiotherapy were randomly assigned into 5 different groups with one group receiving no treatment. The patients were instructed to apply their designated creams once daily from their first radiotherapy session until 1-month post-irradiation. Their skins were graded by a radiation oncologist on a weekly basis until 1-month post-irradiation to identify any skin reactions. The results showed that the administration of the herbal creams or the moisturizing cream could neither reduce the severity nor delay the onset of dermatitis compared with the no treatment group. However, despite the limited benefits from the prophylaxis, the  Cucumis sativus  cream was shown to help with the skin recovery post-irradiation. These results suggested that breast cancer patients undergoing radiotherapy should be advised to apply moisturizing cream to the area of irradiated skin.",2020,The results showed that the administration of the herbal creams or the moisturizing cream could neither reduce the severity nor delay the onset of dermatitis compared with the no treatment group.,"['breast cancer patients undergoing radiotherapy', '153 breast cancer patients undergoing', 'Patients', 'breast cancer patients undergoing']","['Herbal Creams', 'moisturizing cream', 'radiotherapy']","['acute skin reaction', 'severity nor delay the onset of dermatitis']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}]",153.0,0.0204777,The results showed that the administration of the herbal creams or the moisturizing cream could neither reduce the severity nor delay the onset of dermatitis compared with the no treatment group.,"[{'ForeName': 'Saengrawee', 'Initials': 'S', 'LastName': 'Thanthong', 'Affiliation': 'HRH Princess Chulabhorn College of Medical Science, Chulabhorn Royal Academy, Bangkok, Thailand.'}, {'ForeName': 'Rattanaporn', 'Initials': 'R', 'LastName': 'Nanthong', 'Affiliation': 'HRH Princess Chulabhorn College of Medical Science, Chulabhorn Royal Academy, Bangkok, Thailand.'}, {'ForeName': 'Sirikorn', 'Initials': 'S', 'LastName': 'Kongwattanakul', 'Affiliation': 'HRH Princess Chulabhorn College of Medical Science, Chulabhorn Royal Academy, Bangkok, Thailand.'}, {'ForeName': 'Kanyanee', 'Initials': 'K', 'LastName': 'Laebua', 'Affiliation': 'HRH Princess Chulabhorn College of Medical Science, Chulabhorn Royal Academy, Bangkok, Thailand.'}, {'ForeName': 'Pornwaree', 'Initials': 'P', 'LastName': 'Trirussapanich', 'Affiliation': 'HRH Princess Chulabhorn College of Medical Science, Chulabhorn Royal Academy, Bangkok, Thailand.'}, {'ForeName': 'Supaporn', 'Initials': 'S', 'LastName': 'Pitiporn', 'Affiliation': 'Chaopraya Abhaibhubejhr Hospital; Chaopraya Abhaiphubejhr Hospital Foundation, Prachinburi, Thailand.'}, {'ForeName': 'Danupon', 'Initials': 'D', 'LastName': 'Nantajit', 'Affiliation': 'HRH Princess Chulabhorn College of Medical Science, Chulabhorn Royal Academy, Bangkok, Thailand.'}]",Integrative cancer therapies,['10.1177/1534735420920714']
120,32398065,An antibiotic stewardship programme to reduce inappropriate antibiotic prescribing for acute respiratory infections in rural Chinese primary care facilities: study protocol for a clustered randomised controlled trial.,"BACKGROUND


Inappropriate prescribing of antibiotics for acute respiratory infections at the primary care level represents the major source of antibiotic misuse in healthcare, and is a major driver for antimicrobial resistance worldwide. In this study we will develop, pilot and evaluate the effectiveness of a comprehensive antibiotic stewardship programme in China's primary care hospitals to reduce inappropriate prescribing of antibiotics for acute respiratory infections among all ages.
METHODS


We will use a parallel-group, cluster-randomised, controlled, superiority trial with blinded outcome evaluation but unblinded treatment (providers and patients). We will randomise 34 primary care hospitals from two counties within Guangdong province into the intervention and control arm (1:1 overall ratio) stratified by county (8:9 within-county ratio). In the control arm, antibiotic prescribing and management will continue through usual care. In the intervention arm, we will implement an antibiotic stewardship programme targeting family physicians and patients/caregivers. The family physician components include: (1) training using new operational guidelines, (2) improved management and peer-review of antibiotic prescribing, (3) improved electronic medical records and smart phone app facilitation. The patient/caregiver component involves patient education via family physicians, leaflets and videos. The primary outcome is the proportion of prescriptions for acute respiratory infections (excluding pneumonia) that contain any antibiotic(s). Secondary outcomes will address how frequently specific classes of antibiotics are prescribed, how frequently key non-antibiotic alternatives are prescribed and the costs of consultations. We will conduct a qualitative process evaluation to explore operational questions regarding acceptability, cultural appropriateness and burden of technology use, as well as a cost-effectiveness analysis and a long-term benefit evaluation. The duration of the intervention will be 12 months, with another 24 months' post-trial long-term follow-up.
DISCUSSION


Our study is one of the first trials to evaluate the effect of an antibiotic stewardship programme in primary care settings in a low- or middle-income country (LMIC). All interventional activities will be designed to be embedded into routine primary care with strong local ownership. Through the trial we intend to impact on clinical practice and national policy in antibiotic prescription for primary care facilities in rural China and other LMICs.
TRIAL REGISTRATION


ISRCTN, ID: ISRCTN96892547. Registered on 18 August 2019.",2020,"In this study we will develop, pilot and evaluate the effectiveness of a comprehensive antibiotic stewardship programme in China's primary care hospitals to reduce inappropriate prescribing of antibiotics for acute respiratory infections among all ages.
","['primary care facilities in rural China and other LMICs', 'primary care settings in a low- or middle-income country (LMIC', 'rural Chinese primary care facilities', ""China's primary care hospitals to reduce inappropriate prescribing of antibiotics for acute respiratory infections among all ages"", '34 primary care hospitals from two counties within Guangdong province into the intervention and control arm (1:1 overall ratio) stratified by county (8:9 within-county ratio']","['family physician components include: (1) training using new operational guidelines, (2) improved management and peer-review of antibiotic prescribing, (3) improved electronic medical records and smart phone app facilitation', 'comprehensive antibiotic stewardship programme', 'antibiotic stewardship programme']","['proportion of prescriptions for acute respiratory infections (excluding pneumonia) that contain any antibiotic(s', 'specific classes of antibiotics are prescribed, how frequently key non-antibiotic alternatives are prescribed and the costs of consultations']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0337952', 'cui_str': 'Primary care hospital'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C2936303', 'cui_str': 'Inappropriate Prescribing'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}]","[{'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030768', 'cui_str': 'Peer review'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C4505100', 'cui_str': 'Antibiotic Stewardship'}]","[{'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]",,0.170445,"In this study we will develop, pilot and evaluate the effectiveness of a comprehensive antibiotic stewardship programme in China's primary care hospitals to reduce inappropriate prescribing of antibiotics for acute respiratory infections among all ages.
","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhuo', 'Affiliation': 'National Center for Respiratory Diseases, State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Health, Laboratory of Guangdong-Hong Kong -Macao Great Bay, Guangzhou Medical University, 151 Yanjiang Xi Rd, Guangzhou City, 510120, Guangdong, China.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Zhitong', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Joseph Paul', 'Initials': 'JP', 'LastName': 'Hicks', 'Affiliation': 'Nuffield Centre for International Health and Development, University of Leeds, Leeds, UK.'}, {'ForeName': 'Jinkun', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': ""Yuebei People's Hospital, Shaoguan, Guangdong, China.""}, {'ForeName': 'Zhixu', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'National Center for Respiratory Diseases, State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Health, Laboratory of Guangdong-Hong Kong -Macao Great Bay, Guangzhou Medical University, 151 Yanjiang Xi Rd, Guangzhou City, 510120, Guangdong, China.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Haldane', 'Affiliation': 'National Center for Respiratory Diseases, State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Health, Laboratory of Guangdong-Hong Kong -Macao Great Bay, Guangzhou Medical University, 151 Yanjiang Xi Rd, Guangzhou City, 510120, Guangdong, China.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Walley', 'Affiliation': 'Nuffield Centre for International Health and Development, University of Leeds, Leeds, UK.'}, {'ForeName': 'Yubao', 'Initials': 'Y', 'LastName': 'Guan', 'Affiliation': 'National Center for Respiratory Diseases, State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Health, Laboratory of Guangdong-Hong Kong -Macao Great Bay, Guangzhou Medical University, 151 Yanjiang Xi Rd, Guangzhou City, 510120, Guangdong, China.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ""Yuebei People's Hospital, Shaoguan, Guangdong, China.""}, {'ForeName': 'Nanshan', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': 'National Center for Respiratory Diseases, State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Health, Laboratory of Guangdong-Hong Kong -Macao Great Bay, Guangzhou Medical University, 151 Yanjiang Xi Rd, Guangzhou City, 510120, Guangdong, China. nanshan@vip.163.com.'}]",Trials,['10.1186/s13063-020-04303-4']
121,32398642,Oxytocin biases eye-gaze to dynamic and static social images and the eyes of fearful faces: associations with trait autism.,"A key functional effect of intranasal oxytocin with potential therapeutic relevance for autism-spectrum disorder is its reported facilitation of attention towards social stimuli, notably the eye region of faces. In the current randomized placebo-controlled within-subject experiment on 40 healthy males, we investigated the robustness of this facilitation of attention by intranasal oxytocin (24IU) towards social cues. Eye-tracking measures of preference for dynamic and static social vs. non-social stimuli were taken in four different paradigms where autistic individuals tend to exhibit reduced interest in social stimuli. Additionally, we investigated whether oxytocin increases attention towards the eyes relative to other salient face regions in an emotional face paradigm. Results showed that the time spent viewing both dynamic and static social vs. non-social stimuli was negatively associated with trait autism and significantly increased following intranasal oxytocin. For face stimuli, oxytocin primarily increased gaze towards the eyes of fearful expression faces but not for other face emotions. Overall, our findings demonstrate that oxytocin significantly shifts gaze preference towards social vs. non-social stimuli and to the eyes of fearful faces. Importantly, oxytocin appears generally to shift attention more towards salient social stimuli of particular relevance in the context of autism providing further support for its potential therapeutic use in autism-spectrum disorder.",2020,"A key functional effect of intranasal oxytocin with potential therapeutic relevance for autism-spectrum disorder is its reported facilitation of attention towards social stimuli, notably the eye region of faces.","['40 healthy males', 'autism-spectrum disorder']","['oxytocin', 'intranasal oxytocin', 'Oxytocin', 'intranasal oxytocin (24IU) towards social cues', 'placebo']","['time spent viewing both dynamic and static social vs. non-social stimuli', 'shifts gaze preference towards social vs. non-social stimuli', 'trait autism']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]",40.0,0.0281423,"A key functional effect of intranasal oxytocin with potential therapeutic relevance for autism-spectrum disorder is its reported facilitation of attention towards social stimuli, notably the eye region of faces.","[{'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Le', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, 611731, Chengdu, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Kou', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, 611731, Chengdu, China.'}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, 611731, Chengdu, China.'}, {'ForeName': 'Meina', 'Initials': 'M', 'LastName': 'Fu', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, 611731, Chengdu, China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, 611731, Chengdu, China.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, 611731, Chengdu, China.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Kendrick', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, 611731, Chengdu, China. kkendrick@uestc.edu.cn.'}]",Translational psychiatry,['10.1038/s41398-020-0830-x']
122,32398945,"Results of a Randomized, Double-Blinded, Placebo-Controlled, Phase 2.5 Study of Saracatinib (AZD0530), in Patients with Recurrent Osteosarcoma Localized to the Lung.","Purpose


Osteosarcoma is a rare cancer and a third of patients who have completed primary treatment will develop osteosarcoma recurrence. The Src pathway has been implicated in the metastatic behavior of osteosarcoma; about 95% of samples examined express Src or have evidence of downstream activation of this pathway. Saracatinib (AZD0530) is a potent and selective Src kinase inhibitor that was evaluated in adults in Phase 1 studies. The primary goal of this study was to determine if treatment with saracatinib could increase progression-free survival (PFS) for patients who have undergone complete resection of osteosarcoma lung metastases in a double-blinded, placebo-controlled trial.  Patients and Methods . Subjects with recurrent osteosarcoma localized to lung and who had complete surgical removal of all lung nodules were randomized within six weeks after complete surgical resection. Saracatinib, or placebo, was administered at a dose of 175 mg orally, once daily, for up to thirteen 28-day cycles.
Results


Thirty-seven subjects were included in the analyses; 18 subjects were randomized to receive saracatinib and 19 to receive placebo. Intent-to-treat analysis demonstrated a median PFS of 19.4 months in the saracatinib treatment group and 8.6 months in the placebo treatment group ( p =0.47). Median OS was not reached in either arm.
Conclusions


Although saracatinib was well tolerated in this patient population, there was no apparent impact of the drug in this double-blinded, placebo-controlled trial on OS, and Src inhibition alone may not be sufficient to suppress metastatic progression in osteosarcoma. There is a suggestion of potential clinical benefit as evidenced by longer PFS in patients randomized to saracatinib based on limited numbers of patients treated.",2020,"Median OS was not reached in either arm.
","['Thirty-seven subjects were included in the analyses; 18 subjects', 'Subjects with recurrent osteosarcoma localized to lung and who had complete surgical removal of all lung nodules', 'patients who have undergone complete resection of osteosarcoma lung metastases', 'Patients with Recurrent Osteosarcoma Localized to the Lung']","['Saracatinib (AZD0530', 'Placebo', 'Saracatinib, or placebo', 'placebo']","['progression-free survival (PFS', 'Median OS', 'median PFS']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0278779', 'cui_str': 'Osteosarcoma recurrent'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0034079', 'cui_str': 'Nodule of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}, {'cui': 'C0029463', 'cui_str': 'Osteosarcoma'}, {'cui': 'C0153676', 'cui_str': 'Secondary malignant neoplasm of lung'}]","[{'cui': 'C2828242', 'cui_str': 'saracatinib'}, {'cui': 'C1706679', 'cui_str': 'AZD 0530'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",37.0,0.645536,"Median OS was not reached in either arm.
","[{'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Baird', 'Affiliation': 'Center for Cancer Research, NCI, NIH, Building 10 CRC, Room 1W-3750, MSC 110410 Center Drive, Bethesda, MD 20892-1104, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Glod', 'Affiliation': 'Center for Cancer Research, NCI, NIH, Building 10-CRC, Room 1-5750, Bethesda, MD 20892-1100, USA.'}, {'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Steinberg', 'Affiliation': 'Center for Cancer Research, NCI, NIH, 9609 Medical Center Drive, Room 2W334, MSC 9716, Bethesda, MD 20892, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Reinke', 'Affiliation': 'SARC, 24 Frank Lloyd Wright Drive, Ann Arbor, MI 48106, USA.'}, {'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Pressey', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave., MLC 7015, Cincinnati, OH 45229, USA.""}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Mascarenhas', 'Affiliation': ""Children's Hospital Los Angeles, Keck School of Medicine, University of Southern California, 4650 Sunset Boulevard Mail Stop # 54, Los Angeles, CA 90027, USA.""}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Federman', 'Affiliation': ""Mattel Children's Hospital, David Geffen School of Medicine, University of California, 10833 Le Conte Avenue, Los Angeles, CA 90095-6901, USA.""}, {'ForeName': 'Neyssa', 'Initials': 'N', 'LastName': 'Marina', 'Affiliation': 'Stanford University School of Medicine, Palo Alto, CA 94305, USA.'}, {'ForeName': 'Sant', 'Initials': 'S', 'LastName': 'Chawla', 'Affiliation': 'Sarcoma Oncology Research Center, 2811 Wilshire Boulevard, Suite 411, Santa Monica, CA 90403, USA.'}, {'ForeName': 'Joanne P', 'Initials': 'JP', 'LastName': 'Lagmay', 'Affiliation': ""University of Florida Health Shands Children's Hospital, 1600 SW Archer HD 204, Gainesville, FL 32610, USA.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Goldberg', 'Affiliation': 'Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA 02215, USA.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Milhem', 'Affiliation': 'University of Iowa Hospitals and Clinics, 200 Hawkins Drive C32 GH, Iowa City, IA 52242, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Loeb', 'Affiliation': ""Children's Hospital at Montefiore, Albert Einstein College of Medicine, 3411 Wayne Ave., Room 910, Bronx, New York, NY 10467, USA.""}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Butrynski', 'Affiliation': 'Willamette Valley Cancer Institute and Research Center, 520 Country Club Road, Eugene, OR 97401, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Turpin', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, 3333 Burnett Avenue, Cincinnati, OH 45229, USA.""}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Staddon', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania Health System, 230 W. Washington Square, Philadelphia, PA 19106, USA.'}, {'ForeName': 'Sheri L', 'Initials': 'SL', 'LastName': 'Spunt', 'Affiliation': 'Stanford University School of Medicine, 1000 Welch Road Suite 300, MC 5798, Palo Alto, CA 94304, USA.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Jones', 'Affiliation': 'The Royal Marsden Hospital and Institute of Cancer Research, Fulham Road, London SW3 6JJ, UK.'}, {'ForeName': 'Eve T', 'Initials': 'ET', 'LastName': 'Rodler', 'Affiliation': 'Comprehensive Cancer Center University of California, Davis, 2279 45th Street, Sacramento, CA 95717, USA.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Schuetze', 'Affiliation': 'University of Michigan, 1500 East Medical Center Dr. Ann Arbor, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Okuno', 'Affiliation': 'Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Helman', 'Affiliation': ""Children's Hospital Los Angeles, Keck School of Medicine, University of Southern California Children's Hospital Los Angeles, 4650 Sunset Blvd Mail Stop 57, Los Angeles, CA 90027, USA.""}]",Sarcoma,['10.1155/2020/7935475']
123,32398946,Long-Term Follow-up of a Randomized Study of Oral Etoposide versus  Viscum album  Fermentatum Pini as Maintenance Therapy in Osteosarcoma Patients in Complete Surgical Remission after Second Relapse.,"Background


In relapsed osteosarcoma, the 5-yr postrelapse disease-free survival (PRDFS) rate after the second relapse is <20%. In June 2007, a randomized study was started comparing oral etoposide vs  Viscum album  fermentatum Pini (an extract derived from the parasitic plant  Viscum album  L., European mistletoe) as maintenance therapy in patients with metastatic osteosarcoma in complete surgical remission after the second relapse. The primary endpoint was the PRDFS rate at 12 months (compared to the historical control rate). This is a long-term updated result.  Patients and Methods . 10 patients received oral etoposide 50 mg/m 2  daily for 21 days every 28 days for 6 months, and 9 patients received  Viscum album  fermentatum Pini 3 times/wk subcutaneously for 1 year. The study closed early in July 2011 due to insufficient recruitment. Lymphocyte subpopulations were analyzed at T0, T3, T6, T9, and T12 months.
Results


On 30 June 2019, at a median follow-up ITT of 83 months (range 3-144 ms), a median PRDFS of 106 ms (2-144) was observed in the  Viscum  arm with 5/9 patients who never relapse vs a PRDFS of 7 months (3-134) in the etoposide arm (all patients in the Etoposide arm relapsed) (hazard ratio HR = 0.287, 95% CI: 0.076-0.884,  p =0.03). Model forecast 10-yr overall survival rates as 64% in the  Viscum  arm and 33% in the etoposide arm. Lymphocyte subpopulation counts (CD3, CD4, and CD56) showed an increase in the Viscum arm while a decrease was observed in the etoposide arm during treatment.
Conclusions


After 12 years from the start of the trial, the patients in the  Viscum  arm continue to show a considerably longer PRDFS compared to oral etoposide, and a trend for an advantage in OS is evident even if the number of treated patients is too small to draw conclusions.  Viscum  as maintenance treatment after complete surgical remission in relapsed osteosarcoma should be further investigated and compared with other drugs.",2020,"Lymphocyte subpopulation counts (CD3, CD4, and CD56) showed an increase in the Viscum arm while a decrease was observed in the etoposide arm during treatment.
","['patients with metastatic osteosarcoma in complete surgical remission after the second relapse', 'Osteosarcoma Patients in Complete Surgical Remission after Second Relapse']","['oral etoposide', 'Oral Etoposide', 'Viscum album', 'etoposide']","['median PRDFS', 'overall survival rates', 'PRDFS rate', 'Lymphocyte subpopulation counts (CD3, CD4, and CD56', 'Lymphocyte subpopulations', '5-yr postrelapse disease-free survival (PRDFS) rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278512', 'cui_str': 'Metastatic osteosarcoma'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0029463', 'cui_str': 'Osteosarcoma'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0331018', 'cui_str': 'Viscum album'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0079720', 'cui_str': 'Lymphocyte Subpopulations'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0108754', 'cui_str': 'Lymphocyte antigen CD56'}]",,0.0672894,"Lymphocyte subpopulation counts (CD3, CD4, and CD56) showed an increase in the Viscum arm while a decrease was observed in the etoposide arm during treatment.
","[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Longhi', 'Affiliation': 'Chemotherapy Division, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Marilena', 'Initials': 'M', 'LastName': 'Cesari', 'Affiliation': 'Chemotherapy Division, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Serra', 'Affiliation': 'Laboratory of Experimental Oncology, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Erminia', 'Initials': 'E', 'LastName': 'Mariani', 'Affiliation': 'Immunoreumathology and Tissue Regeneration Laboratory, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.'}]",Sarcoma,['10.1155/2020/8260730']
124,32399045,A Randomized Controlled Trial of the Treatment of Rotator Cuff Tears with Bone Marrow Concentrate and Platelet Products Compared to Exercise Therapy: A Midterm Analysis.,"Injectable regenerative therapies such as bone marrow concentrate (BMC) and platelet-rich plasma (PRP) may represent a safe alternative in the treatment of rotator cuff tears. This is a midterm review of a randomized, crossover trial comparing autologous BMC and platelet product injections versus exercise therapy in the treatment of partial and full-thickness supraspinatus tears. Patients enrolled into the study were between 18 and 65 years of age presenting to an outpatient orthopedic clinic with partial to full thickness, nonretracted supraspinatus tendon tears. Enrolled patients were randomized to either ultrasound-guided autologous BMC with PRP and platelet lysate (PL) percutaneous injection treatment or exercise therapy. Patients could cross over to BMC treatment after at least 3 months of exercise therapy. Patients completed the Disability of the Arm, Shoulder and Hand (DASH) scores as the primary outcome measure. Secondary outcomes included the numeric pain scale (NPS), a modified Single Assessment Numeric Evaluation (SANE), and a blinded MRI review. At this midterm review, results from 25 enrolled patients who have reached at least 12-month follow-up are presented. No serious adverse events were reported. Significant differences were seen in patient reported outcomes for the BMC treatment compared to exercise therapy at 3 and 6 months for pain, and for function and reported improvement (SANE) at 3 months ( p  < .05). Patients reported a mean 89% improvement at 24 months, with sustained functional gains and pain reduction. MRI review showed a size decrease of most tears post-BMC treatment. These findings suggest that ultrasound-guided BMC and platelet product injections are a safe and useful alternative to conservative exercise therapy of torn, nonretracted supraspinatus tendons. This trial is registered with NCT01788683.",2020,"Significant differences were seen in patient reported outcomes for the BMC treatment compared to exercise therapy at 3 and 6 months for pain, and for function and reported improvement (SANE) at 3 months ( p  < .05).","['rotator cuff tears', 'partial and full-thickness supraspinatus tears', 'Patients enrolled into the study were between 18 and 65 years of age presenting to an outpatient orthopedic clinic with partial to full thickness, nonretracted supraspinatus tendon tears', '25 enrolled patients who have reached at least 12-month follow-up are presented']","['ultrasound-guided autologous BMC with PRP and platelet lysate (PL) percutaneous injection treatment or exercise therapy', 'autologous BMC and platelet product injections versus exercise therapy', 'Rotator Cuff Tears with Bone Marrow Concentrate and Platelet Products']","['sustained functional gains and pain reduction', 'serious adverse events', 'Disability of the Arm, Shoulder and Hand (DASH) scores', 'numeric pain scale (NPS), a modified Single Assessment Numeric Evaluation (SANE), and a blinded MRI review']","[{'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0439809', 'cui_str': 'Full thickness'}, {'cui': 'C0439059', 'cui_str': 'Supraspinatus tear'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3838700', 'cui_str': 'Orthopedic clinic'}, {'cui': 'C0224868', 'cui_str': 'Structure of tendon of supraspinatus muscle'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0443116', 'cui_str': 'Platelet product'}, {'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0282443', 'cui_str': 'Review'}]",25.0,0.0836088,"Significant differences were seen in patient reported outcomes for the BMC treatment compared to exercise therapy at 3 and 6 months for pain, and for function and reported improvement (SANE) at 3 months ( p  < .05).","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Centeno', 'Affiliation': 'Centeno-Schultz Clinic, 403 Summit Blvd 201, Broomfield, Colorado 80021, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Fausel', 'Affiliation': 'Centeno-Schultz Clinic, 403 Summit Blvd 201, Broomfield, Colorado 80021, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Stemper', 'Affiliation': 'Regenexx, LLC, 6151 Thornton Ave #200, Des Moines, Iowa 50321, USA.'}, {'ForeName': 'Ugochi', 'Initials': 'U', 'LastName': 'Azuike', 'Affiliation': 'Centeno-Schultz Clinic, 403 Summit Blvd 201, Broomfield, Colorado 80021, USA.'}, {'ForeName': 'Ehren', 'Initials': 'E', 'LastName': 'Dodson', 'Affiliation': 'Regenexx, LLC, 6151 Thornton Ave #200, Des Moines, Iowa 50321, USA.'}]",Stem cells international,['10.1155/2020/5962354']
125,32399072,Design exploration predicts designer creativity: a deep learning approach.,"This study examined brain activation in graphic designers responding to pictorial stimulation during exploration tasks and determined the predictive effects of design exploration on designer creativity through a deep learning approach. The top and bottom 25% (10 each participants) were assigned high-creativity and low-creativity groups, respectively. The results provided the following indications. (i) Shallow architectures had higher prediction accuracy than deeper architectures. (ii) The prediction accuracy of shallow long short-term memory networks was higher than that of convolution neural networks. (iii) Bandpower exhibited increased prediction accuracy, and shallow LSTM networks with differing power spectra among independent components outperformed other deep learning methods. (iv) Direct acyclic graph networks did not improve prediction accuracy. (v) Design exploration could effectively predict designer creativity.",2020,"Bandpower exhibited increased prediction accuracy, and shallow LSTM networks with differing power spectra among independent components outperformed other deep learning methods.",[],[],"['prediction accuracy', 'prediction accuracy, and shallow LSTM networks', 'designer creativity']",[],[],"[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0010297', 'cui_str': 'Creative thought'}]",,0.0316321,"Bandpower exhibited increased prediction accuracy, and shallow LSTM networks with differing power spectra among independent components outperformed other deep learning methods.","[{'ForeName': 'Yu-Cheng', 'Initials': 'YC', 'LastName': 'Liu', 'Affiliation': 'Department of Bio-Industry Communication and Development, National Taiwan University, No. 1, Sec. 4, Roosevelt Road, Taipei, 10617 Taiwan.'}, {'ForeName': 'Chaoyun', 'Initials': 'C', 'LastName': 'Liang', 'Affiliation': 'Department of Bio-Industry Communication and Development, National Taiwan University, No. 1, Sec. 4, Roosevelt Road, Taipei, 10617 Taiwan.'}]",Cognitive neurodynamics,['10.1007/s11571-020-09569-7']
126,32399107,Peptide-based formula versus standard-based polymeric formula for critically ill children: is it superior for patients' tolerance?,"Introduction


Malnutrition affects 50% of hospitalized children and 25-70% of critically ill children. Enteral tube feeding is generally considered the preferred modality for critically ill pediatric patients. Clinical advantages of using peptide-based formulas are still controversial in critically ill children. The aim of this study was to compare the effect of a peptide-based formula versus a standard polymeric formula on feeding tolerance and whether this will affect the outcome among critically ill children.
Material and methods


This single blind case control study was conducted on 180 randomly selected critically ill children in the pediatric critical care unit (PICU) of Ain Shams University. Patients were divided into 2 groups: a group receiving a standard polymeric formula (group 1; 90 patients) and a group receiving a peptide-based formula (group II; 90 patients). Nutritional requirements, days to reach full enteral feeding, feeding intolerance symptoms and anthropometric measurements were recorded for all patients at admission together with their pediatric risk of mortality score (PRISM). Length of PICU stay, occurrence of sepsis together with survival were analyzed at discharge as outcome measures.
Results


Patients receiving a peptide-based formula showed a significant decrease in feeding interruptions and abdominal distention ( p  < 0.000), reached full enteral feeding faster (2.60 ±0.74 days versus 5.36 ±1.00 days in patients received polymeric standard formula;  p  < 0.001) and improved weight gain ( p  < 0.028). Moreover, duration of sepsis was significantly shorter ( p  < 0.045), but no difference in mortality was recorded between patient groups.
Conclusions


Peptide-based formula feeding was better tolerated than standard polymeric formula feeding in critically ill pediatric patients. However, the choice of patients receiving the peptide-based formula needs to be further evaluated.",2020,"Results


Patients receiving a peptide-based formula showed a significant decrease in feeding interruptions and abdominal distention ( p  < 0.000), reached full enteral feeding faster (2.60 ±0.74 days versus 5.36 ±1.00 days in patients received polymeric standard formula;  p  < 0.001) and improved weight gain ( p  < 0.028).","['critically ill pediatric patients', '180 randomly selected critically ill children in the pediatric critical care unit (PICU) of Ain Shams University', 'critically ill children']","['peptide-based formula versus a standard polymeric formula', 'peptide-based formulas', 'peptide-based formula', 'standard polymeric formula', 'Enteral tube feeding', 'Peptide-based formula versus standard-based polymeric formula']","['full enteral feeding faster', 'feeding interruptions and abdominal distention', 'weight gain', 'mortality score (PRISM', 'mortality', 'Length of PICU stay, occurrence of sepsis together with survival', 'duration of sepsis']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0347129', 'cui_str': 'Dysplasia of anus'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0041281', 'cui_str': 'Tube feeding of patient'}]","[{'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0475502', 'cui_str': 'Pediatric risk of mortality'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",180.0,0.0463907,"Results


Patients receiving a peptide-based formula showed a significant decrease in feeding interruptions and abdominal distention ( p  < 0.000), reached full enteral feeding faster (2.60 ±0.74 days versus 5.36 ±1.00 days in patients received polymeric standard formula;  p  < 0.001) and improved weight gain ( p  < 0.028).","[{'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'Ibrahim', 'Affiliation': 'Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Mervat', 'Initials': 'M', 'LastName': 'Mansour', 'Affiliation': 'Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Yasmin Gamal', 'Initials': 'YG', 'LastName': 'El Gendy', 'Affiliation': 'Ain Shams University, Cairo, Egypt.'}]",Archives of medical science : AMS,['10.5114/aoms.2020.94157']
127,32399109,Effect of tranexamic acid on symptomatic venous thromboembolism in patients undergoing primary total knee arthroplasty.,"Introduction


This study aimed to investigate the effect of tranexamic acid (TXA) with sequential routine anticoagulation on postoperative symptomatic venous thromboembolism (VTE) in patients undergoing primary total knee arthroplasty (TKA).
Material and methods


This was a prospective study with randomized trials. From January 2013 to May 2015, 1880 patients undergoing primary TKA were enrolled in this study. Seven hundred and twenty patients who received TXA injection were included in the TXA group while 1160 patients who received placebo injection were included in the control group. Patients in the TXA group were treated with intravenous TXA or topical intravenous TXA, and all received sequential routine anticoagulation 12 h after the operation. We extracted data of patients' sex, age, primary diagnoses, and comorbidities that could potentially affect the prevalence rate of VTE. To discuss the risk factors of symbolic VTE, comparisons were made within the TXA group between patients with symbolic VTE and non-symbolic VTE. Logistic regression analysis was performed to analyze the concurrent effects of various factors on the prevalence rate of postoperative VTE.
Results


Thigh perimeter was not closely associated with TXA injection. Within the TXA group, 24 (3.3%) patients had perioperative symptomatic VTE, 16 (2.2%) deep vein thrombosis (DVT) and 8 (1.1%) pulmonary embolism. High body mass index (BMI), low fibrinogen (Fbg) and simultaneous bilateral TKA were significant risk factors in both univariate analysis and multivariate analysis.
Conclusions


Increased BMI, low Fbg, and simultaneous bilateral TKA could act as risk factors for postoperative symptomatic VTE treated with TXA.",2020,"High body mass index (BMI), low fibrinogen (Fbg) and simultaneous bilateral TKA were significant risk factors in both univariate analysis and multivariate analysis.
","['patients undergoing primary total knee arthroplasty', 'Seven hundred and twenty patients who received TXA injection were included in the TXA group while 1160 patients who received', 'From January 2013 to May 2015, 1880 patients undergoing primary TKA', 'patients undergoing primary total knee arthroplasty (TKA']","['tranexamic acid (TXA', 'TXA', 'intravenous TXA or topical intravenous TXA', 'placebo injection', 'sequential routine anticoagulation', 'tranexamic acid']","['High body mass index (BMI), low fibrinogen (Fbg) and simultaneous bilateral TKA', 'prevalence rate of VTE', 'pulmonary embolism', 'deep vein thrombosis (DVT', 'postoperative symptomatic venous thromboembolism (VTE', 'symptomatic venous thromboembolism', 'perioperative symptomatic VTE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4517865', 'cui_str': '720'}, {'cui': 'C4237836', 'cui_str': 'Tranexamic Acid Injection'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0553681', 'cui_str': 'Hypofibrinogenemia'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",1880.0,0.0766469,"High body mass index (BMI), low fibrinogen (Fbg) and simultaneous bilateral TKA were significant risk factors in both univariate analysis and multivariate analysis.
","[{'ForeName': 'Huiming', 'Initials': 'H', 'LastName': 'Peng', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Longchao', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xisheng', 'Initials': 'X', 'LastName': 'Weng', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jiliang', 'Initials': 'J', 'LastName': 'Zhai', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wenwei', 'Initials': 'W', 'LastName': 'Qian', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Gao', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Archives of medical science : AMS,['10.5114/aoms.2020.92444']
128,32399130,A Clinical Randomized Controlled Trial of Acupuncture Treatment of Gastroparesis Using Different Acupoints.,"Objective


To explore the effect of ""selecting acupoints by site"" on the synergy effect of ""acupoint compatibility"" according to the clinical efficacy of acupuncture treatment of patients with gastroparesis.
Methods


A total of 99 patients who met the diagnostic criteria for gastroparesis were enrolled in 3 clinical centers and randomly divided into group A (33 cases), group B (33 cases, 1 case of shedding), and group C (33 cases, 1 case of shedding). In group A, acupuncture was performed at Zhongwan (CV 12) and Zusanli (ST 36); in group B, acupuncture was performed at Neiguan (PC 6) and Zusanli (ST 36); in group C, acupuncture was performed at nonacupoint and Zusanli (ST 36). Treatment was performed for 30 minutes every day, 5 days as a course of treatment. There were 2 days off between courses and three courses in total. Differences in a main symptom index of gastroparesis (GCSI) scores, 9 symptom scores, and a health questionnaire (SF-36) were compared between each group before and after treatment and 4 weeks after the end of treatment. The difference of gastric emptying rate was compared before and after treatment.
Results


The GCSI scores of each group after treatment and at follow-up were significantly lower than those before treatment ( P  < 0.01), and the reduction in group A was greater than that of groups B and C ( P  < 0.01). The score of each symptom was meaningfully lower than that before treatment ( P  < 0.01 or  P  < 0.05). The effect was best in group A, followed by group B. After treatment, the barium meal in the stomach of the three groups was significantly reduced compared with before treatment ( P  < 0.01). There was no statistical difference between the groups. The results of SF-36 showed that acupuncture treatment can improve health status, to a certain extent, and there was no significant difference in the three groups.
Conclusion


(1) Acupuncture is an effective method for the treatment of gastroparesis. (2) The combination of Zhongwan (CV 12) with Zusanli (ST 36) showed the most promising effect on relief of the symptoms in patients with gastroparesis. (3) ""Selecting acupoints by site"" is the key factor affecting the synergy effect of ""acupoint compatibility."" This trial was registered with the International Center for Clinical Trials (registration no. NCT02594397).",2020,The score of each symptom was meaningfully lower than that before treatment ( P  < 0.01 or  P  < 0.05).,"['99 patients who met the diagnostic criteria for gastroparesis were enrolled in 3 clinical centers', 'patients with gastroparesis']","['acupuncture', 'Acupuncture']","['gastric emptying rate', 'GCSI scores', 'score of each symptom', 'health status', 'main symptom index of gastroparesis (GCSI) scores, 9 symptom scores, and a health questionnaire (SF-36']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0967114', 'cui_str': 'goblet cell silencer inhibitor'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",99.0,0.0357108,The score of each symptom was meaningfully lower than that before treatment ( P  < 0.01 or  P  < 0.05).,"[{'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Xuefen', 'Affiliation': 'College of Acu-Moxibustion and Tuina, Hunan University of Traditional Chinese Medicine, Changsha, Hunan 410208, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ping', 'Affiliation': 'College of Acu-Moxibustion and Tuina, Hunan University of Traditional Chinese Medicine, Changsha, Hunan 410208, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'College of Acu-Moxibustion and Tuina, Hunan University of Traditional Chinese Medicine, Changsha, Hunan 410208, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Xiaoli', 'Affiliation': 'College of Acu-Moxibustion and Tuina, Hunan University of Traditional Chinese Medicine, Changsha, Hunan 410208, China.'}, {'ForeName': 'Zenghui', 'Initials': 'Z', 'LastName': 'Yue', 'Affiliation': 'College of Acu-Moxibustion and Tuina, Hunan University of Traditional Chinese Medicine, Changsha, Hunan 410208, China.'}]",Pain research & management,['10.1155/2020/8751958']
129,32399201,An evaluation of a personalised text message reminder compared to a standard text message on postal questionnaire response rates: an embedded randomised controlled trial.,"Background : Research outcome data is commonly collected using postal questionnaires; however, poor response can introduce bias and reduce statistical power. Text messaging is simple, cost-effective, and can be customised to the individual. Personalised, reminder text messages may improve response rates.  Methods : A two-arm, parallel group 'Study within a Trial' (SWAT) was embedded within the Occupational Therapist Intervention Study (OTIS), a randomised controlled trial of a home assessment for falls prevention in older people.  OTIS participants who provided a mobile phone number were randomly allocated (1:1) to receive either a personalised text message (Title, Surname, plus York Trials Unit (YTU) text) or the standard YTU text alone, prior to receiving their four-month post-randomisation follow-up postal questionnaire. The primary outcome measure was the proportion of participants who returned the questionnaire. Secondary outcomes were: time to response, completeness of response, requirement of a reminder letter, and cost-effectiveness. Binary data were compared using logistic regression and time to response by Cox proportional hazards regression.  Results : A total of 403 participants were randomised: 201 to the personalised text and 202 to the standard text.  Of the 283 participants included in the final analysis, 278 (98.2%) returned their questionnaire; 136 (97.8%) for the personalised text versus 142 (98.6%) for the standard text (adjusted odds ratio 0.64, 95% CI 0.10 to 3.88, p=0.63).  The median time to response was nine days in both groups.  In total, 271 (97.5%) participants returned a complete questionnaire; 133 (97.8%) in the personalised text versus 138 (97.2%) for the standard text.  In total, 21 reminder letters were sent. The additional cost of personalised text messages was £0.04 per participant retained.  Conclusions : Personalised texts were not superior to standard texts in any outcome assessed in our study. Further SWATs are needed to perform a meta-analysis and obtain more evidence.  Registration : ISRCTN22202133; SWAT 35.",2020,"A two-arm, parallel group 'Study within a Trial' (SWAT) was embedded within the Occupational Therapist Intervention Study (OTIS), a randomised controlled trial of a home assessment for falls prevention in older people.  ","['older people', '403 participants were randomised: 201 to the personalised text and 202 to the standard text', 'OTIS participants who provided a mobile phone number', 'Registration ']","['personalised text message (Title, Surname, plus York Trials Unit (YTU) text) or the standard YTU text alone, prior to receiving their four-month post-randomisation follow-up postal questionnaire', 'personalised text message reminder']","['proportion of participants who returned the questionnaire', 'postal questionnaire response rates', 'response rates', 'time to response, completeness of response, requirement of a reminder letter, and cost-effectiveness', 'median time to response']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1301584', 'cui_str': 'Surname'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",403.0,0.200782,"A two-arm, parallel group 'Study within a Trial' (SWAT) was embedded within the Occupational Therapist Intervention Study (OTIS), a randomised controlled trial of a home assessment for falls prevention in older people.  ","[{'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Cochrane', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Welch', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cockayne', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Torgerson', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",F1000Research,['10.12688/f1000research.22361.1']
130,32399253,"Acthar Gel (repository corticotropin injection) for persistently active SLE: study design and baseline characteristics from a multicentre, randomised, double-blind, placebo-controlled trial.","Objective


SLE is a chronic inflammatory autoimmune disease characterised by the excessive production of autoantibodies, immune complexes and proinflammatory cytokines. Repository corticotropin injection (RCI) is a naturally sourced complex mixture of adrenocorticotropic hormone analogues and other pituitary peptides. RCI is approved by the US Food and Drug Administration for use during an exacerbation or as maintenance therapy in select cases of SLE. This paper discusses the design and baseline characteristics of a multicentre, double-blind, randomised, placebo-controlled, 24-week clinical trial evaluating the effect of RCI in reducing disease activity for patients with persistently active SLE despite moderate-dose corticosteroid use.
Methods


Efficacy will be evaluated using the SLE Responder Index-4 (SRI-4), SLE Disease Activity Index-2000 (SLEDAI-2K), British Isles Lupus Assessment Group-2004 (BILAG-2004) and Physician's Global Assessment (PGA). The primary efficacy endpoint will be the proportion of SRI-4 responders at week 16. Secondary and exploratory endpoints will include changes in disease activity scores over time, prednisone dose and biomarkers of inflammation and bone turnover. The safety and tolerability profile of RCI will also be evaluated through adverse event profiles, physical examination, clinical laboratory tests and serum cortisol levels.
Results


Target enrolment for this global study is 270 patients, and as of 15 November 2019, the modified intent-to-treat population included 169 patients. The study cohort had 91.7% women, had a mean age of 39.7 years, mean SLEDAI-2K total score of 9.9, mean BILAG-2004 total score of 18.1, mean PGA of 59.7 and mean prednisone or equivalent daily dose of 11.1 mg. A total of 79.3% and 64.5% of patients were receiving concomitant antimalarial or immunosuppressive therapy, respectively.
Conclusions


Data from this study will provide valuable insights into the therapeutic role of RCI in refractory SLE, as well as important information regarding its safety profile.",2020,"Methods


Efficacy will be evaluated using the SLE Responder Index-4 (SRI-4), SLE Disease Activity Index-2000 (SLEDAI-2K), British Isles Lupus Assessment Group-2004 (BILAG-2004) and Physician's Global Assessment (PGA).","['patients with persistently active SLE despite moderate-dose corticosteroid use', '270 patients, and as of 15 November 2019, the modified intent-to-treat population included 169 patients', 'The study cohort had 91.7% women, had a mean age of 39.7 years, mean SLEDAI-2K total score of 9.9, mean BILAG-2004 total score of 18.1, mean PGA of 59.7 and mean prednisone or equivalent daily dose of 11.1\u2009mg']","['Repository corticotropin injection (RCI', 'RCI', 'Acthar Gel (repository corticotropin injection', 'placebo']","['proportion of SRI-4 responders', 'disease activity', 'safety and tolerability profile of RCI', ""SLE Responder Index-4 (SRI-4), SLE Disease Activity Index-2000 (SLEDAI-2K), British Isles Lupus Assessment Group-2004 (BILAG-2004) and Physician's Global Assessment (PGA"", 'disease activity scores over time, prednisone dose and biomarkers of inflammation and bone turnover']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0451528', 'cui_str': 'Systemic lupus erythematosus disease activity index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0020750', 'cui_str': 'Iceland'}, {'cui': 'C0024131', 'cui_str': 'Lupus vulgaris'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0718234', 'cui_str': 'Acthar'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0451528', 'cui_str': 'Systemic lupus erythematosus disease activity index'}, {'cui': 'C0020750', 'cui_str': 'Iceland'}, {'cui': 'C0024131', 'cui_str': 'Lupus vulgaris'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}]",,0.466664,"Methods


Efficacy will be evaluated using the SLE Responder Index-4 (SRI-4), SLE Disease Activity Index-2000 (SLEDAI-2K), British Isles Lupus Assessment Group-2004 (BILAG-2004) and Physician's Global Assessment (PGA).","[{'ForeName': 'Anca D', 'Initials': 'AD', 'LastName': 'Askanase', 'Affiliation': 'Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Enxu', 'Initials': 'E', 'LastName': 'Zhao', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Bedminster, New Jersey, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Bedminster, New Jersey, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Connolly-Strong', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Bedminster, New Jersey, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Furie', 'Affiliation': 'Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA.'}]",Lupus science & medicine,['10.1136/lupus-2020-000383']
131,32399326,Intracameral Triamcinolone Acetonide Versus Topical Dexamethasone: A Comparison of Anti-inflammatory Effects After Phacoemulsification.,"Study objective and design The objective of this study was to determine the effectiveness of triamcinolone acetonide when used as a single dose as compared to the topical use of dexamethasone to control the inflammation after phacoemulsification. The study was a randomized controlled trial conducted in the Department of Ophthalmology at the District Headquarter (DHQ) Teaching Hospital, Dera Ghazi Khan, from March 1, 2018, to August 31, 2019. Materials and methods Eighty patients were included in the study. All patients were assigned to two groups of 40 patients each using the lottery method. Group A patients were treated with a 1-mg intracameral injection of triamcinolone acetonide postoperatively after phacoemulsification. Group B patients were administered 0.1% dexamethasone eye drops with a dosage of one drop every four hours for four weeks. Postoperative follow-up was planned for day one, day seven, and day 28. Results The postoperative inflammation cell values of Group A on day one, day seven, and day 28 were 1.68 ±0.84, 0.22 ±0.15, and 0.12 ±0.23, respectively, while the postoperative inflammation cell values of Group B on day one, day seven, and day 28 were 1.91 ±0.75, 0.28 ±0.15, and 0.09 ±0.20, respectively. The postoperative inflammation flare values of Group A on day one, day seven, and day 28 were 0.31 ±0.37, 0.03 ±0.44, and 0.00 ±0.22, respectively, while the postoperative inflammation flare values of Group B on day one, day seven, and day 28 were 0.25 ±0.26, 0.22 ±0.46, and 0.02 ±0.18, respectively. Conclusion The efficacy of both modes of treatments is comparable; however, triamcinolone acetonide is preferable to dexamethasone, as its intracameral injection generally results in better compliance than multiple dosages of topical eye drops of dexamethasone.",2020,"The postoperative inflammation flare values of Group A on day one, day seven, and day 28 were 0.31 ±0.37, 0.03 ±0.44, and 0.00 ±0.22, respectively, while the postoperative inflammation flare values of Group B on day one, day seven, and day 28 were 0.25 ±0.26, 0.22 ±0.46, and 0.02 ±0.18, respectively.","['Materials and methods Eighty patients were included in the study', 'Department of Ophthalmology at the District Headquarter (DHQ) Teaching Hospital, Dera Ghazi Khan, from March 1, 2018, to August 31, 2019']","['dexamethasone', 'triamcinolone acetonide', 'Intracameral Triamcinolone Acetonide Versus Topical Dexamethasone']","['postoperative inflammation flare values', 'postoperative inflammation cell values']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]",80.0,0.0446916,"The postoperative inflammation flare values of Group A on day one, day seven, and day 28 were 0.31 ±0.37, 0.03 ±0.44, and 0.00 ±0.22, respectively, while the postoperative inflammation flare values of Group B on day one, day seven, and day 28 were 0.25 ±0.26, 0.22 ±0.46, and 0.02 ±0.18, respectively.","[{'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Haider Shaheen', 'Affiliation': 'Ophthalmology, District Headquarter Teaching Hospital, Dera Ghazi Khan, PAK.'}, {'ForeName': 'Muhammad Saad', 'Initials': 'MS', 'LastName': 'Ullah', 'Affiliation': 'Ophthalmology, District Headquarter Teaching Hospital, Dera Ghazi Khan, PAK.'}, {'ForeName': 'Syed Ahmer', 'Initials': 'SA', 'LastName': 'Hussain', 'Affiliation': 'Ophthalmology, District Headquarter Teaching Hospital, Dera Ghazi Khan, PAK.'}, {'ForeName': 'Aamir', 'Initials': 'A', 'LastName': 'Furqan', 'Affiliation': 'Anesthesia and Critical Care, Chaudhry Pervaiz Elahi Institute of Cardiology, Multan, PAK.'}]",Cureus,['10.7759/cureus.7592']
132,32399396,Evidence for using dextromethorphan-quinidine for the treatment of agitation in dementia.,"Behavioral and psychological symptoms including agitation are common in dementia, and are associated with decreased quality of life, increased risk of institutionalization, and greater patient and caregiver distress. Pharmacological agents used for management of behavioral and psychological symptoms of dementia are limited by their tolerability, prompting a need for identifying efficacious and safe pharmacological treatments for managing agitation in dementia. The combination of dextromethorphan and quinidine sulfate is approved for pseudobulbar affect, and may be effective in managing agitation in dementia. A review of literature found only one randomized controlled trial that evaluated the use of dextromethorphan-quinidine for the management of agitation in dementia when compared to placebo. Data from this trial demonstrated that dextromethorphan-quinidine decreased agitation in dementia, and was well tolerated. Although promising, further research is needed before dextromethorphan-quinidine combination can be accepted as a standard treatment for agitation in dementia.",2020,"Behavioral and psychological symptoms including agitation are common in dementia, and are associated with decreased quality of life, increased risk of institutionalization, and greater patient and caregiver distress.",['agitation in dementia'],"['dextromethorphan-quinidine', 'dextromethorphan and quinidine sulfate', 'placebo']",['tolerated'],"[{'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C2946981', 'cui_str': 'Dextromethorphan / Quinidine'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0034415', 'cui_str': 'Quinidine sulfate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0561217,"Behavioral and psychological symptoms including agitation are common in dementia, and are associated with decreased quality of life, increased risk of institutionalization, and greater patient and caregiver distress.","[{'ForeName': 'Rajesh R', 'Initials': 'RR', 'LastName': 'Tampi', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Cleveland Clinic Akron General, Akron, OH 44106, United States.'}, {'ForeName': 'Pallavi', 'Initials': 'P', 'LastName': 'Joshi', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Northwell Health-Staten Island University Hospital, Staten Island, NY 10306, United States.'}, {'ForeName': 'Padmapriya', 'Initials': 'P', 'LastName': 'Marpuri', 'Affiliation': 'Department of Psychiatry, Einstein Medical Center, Philadelphia, PA 19141, United States.'}, {'ForeName': 'Deena J', 'Initials': 'DJ', 'LastName': 'Tampi', 'Affiliation': 'Diamond Healthcare, Richmond, VA 23219, United States.'}]",World journal of psychiatry,['10.5498/wjp.v10.i4.29']
133,32399407,Collagen crosslinking with photoactivated riboflavin in advanced infectious keratitis with corneal melting: Electrophysiological Study.,"AIM


To assess the effect of photoactivated chromophore for keratitis crosslinking (PACK-CXL) in case of severe keratitis with melting on the electrophysiological function of the retina and the optic nerve.
METHODS


The study included 32 eyes of 32 patients with smear positive severe infectious keratitis with corneal melting. The patients were randomly divided into two groups. Group I (control group) included 16 eyes received systemic and topical antimicrobial drugs guarded by culture and sensitivity test. Group II underwent CXL and then continued their antimicrobial treatment. Full field electroretinogram (ERG) and flash visual evoked potential (VEP) were done for each patient in both groups basically and then 1wk, 1 and 3mo post-treatment to assess the changes in the electrophysiological function of the retina and optic nerve.
RESULTS


Healing of 10 eyes in group I in comparison to 14 eyes in group II was recorded. The mean duration of healing was 36.56±5.21d in group I  vs  20.2±4.4d in group II ( P <0.005). In group II, ERG showed an insignificant reduction of all parameters of ERG and VEP after CXL. The amplitude of scotopic rod response, oscillatory potential amplitude, flicker amplitude and photopic cone response were insignificantly decreased ( P =0.4, 0.8, 0.1, and 0.3 respectively). There were insignificant prolongation of latencies of scotopic rod, oscillatory potential, flicker and photopic cone response ( P =0.2, 0.7, 0.5 and 0.1). There was slight delay in latency of VEP without a significant reduction in amplitude.
CONCLUSION


CXL is an effective technique in treatment of severe infectious keratitis with melting as it halts the melting process with acceptable safety on the retinal and optic nerve function.",2020,"There were insignificant prolongation of latencies of scotopic rod, oscillatory potential, flicker and photopic cone response ( P =0.2, 0.7, 0.5 and 0.1).","['32 eyes of 32 patients with smear positive severe infectious keratitis with corneal melting', 'advanced infectious keratitis with corneal melting']","['CXL', 'photoactivated chromophore for keratitis crosslinking (PACK-CXL', 'Collagen crosslinking with photoactivated riboflavin', 'systemic and topical antimicrobial drugs guarded by culture and sensitivity test']","['mean duration of healing', 'ERG and VEP', 'slight delay in latency of VEP', 'amplitude of scotopic rod response, oscillatory potential amplitude, flicker amplitude and photopic cone response', 'latencies of scotopic rod, oscillatory potential, flicker and photopic cone response', 'Full field electroretinogram (ERG) and flash visual evoked potential (VEP']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3898765', 'cui_str': 'Keratitis caused by infection'}, {'cui': 'C1168305', 'cui_str': 'Corneal melt'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0022568', 'cui_str': 'Keratitis'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C1136254', 'cui_str': 'Antimicrobial-containing product'}, {'cui': 'C0278253', 'cui_str': 'Guarded prognosis'}, {'cui': 'C0430388', 'cui_str': 'Culture and susceptibility'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0013867', 'cui_str': 'Electroretinography'}, {'cui': 'C0015217', 'cui_str': 'Visual evoked potential'}, {'cui': 'C2937276', 'cui_str': 'Slight'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0035086', 'cui_str': 'Renal osteodystrophy'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0206428', 'cui_str': 'Cone of retina'}, {'cui': 'C0439724', 'cui_str': 'Full field'}, {'cui': 'C0429415', 'cui_str': 'Flash visual evoked potentials'}]",32.0,0.0240024,"There were insignificant prolongation of latencies of scotopic rod, oscillatory potential, flicker and photopic cone response ( P =0.2, 0.7, 0.5 and 0.1).","[{'ForeName': 'Eman A', 'Initials': 'EA', 'LastName': 'Awad', 'Affiliation': 'Ophthalmology Center, Faculty of Medicine, Mansoura University, Mansoura PO.35516, Egypt.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Abdelkader', 'Affiliation': 'Ophthalmology Center, Faculty of Medicine, Mansoura University, Mansoura PO.35516, Egypt.'}, {'ForeName': 'Ameera G', 'Initials': 'AG', 'LastName': 'Abdelhameed', 'Affiliation': 'Ophthalmology Center, Faculty of Medicine, Mansoura University, Mansoura PO.35516, Egypt.'}, {'ForeName': 'Walid M', 'Initials': 'WM', 'LastName': 'Gaafar', 'Affiliation': 'Ophthalmology Center, Faculty of Medicine, Mansoura University, Mansoura PO.35516, Egypt.'}, {'ForeName': 'Tharwat H', 'Initials': 'TH', 'LastName': 'Mokbel', 'Affiliation': 'Ophthalmology Center, Faculty of Medicine, Mansoura University, Mansoura PO.35516, Egypt.'}]",International journal of ophthalmology,['10.18240/ijo.2020.04.07']
134,32399409,Effect of capsular tension ring implantation on predicted refractive error after cataract surgery in patients with pseudoexfoliation syndrome.,"AIM


To investigate the effect of capsular tension ring (CTR) implantation on predicted refractive error after cataract surgery in patients with pseudoexfoliation (PEX) syndrome.
METHODS


This double-blind randomized clinical trial was conducted on 60 patients with PEX syndrome referring to Imam Khomeini Hospital affiliated to Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran, for undergoing cataract surgery. The study population was divided into two groups, namely CTR group ( n =30) and non-CTR group (control group;  n =30). The refractive error and anterior chamber depth (ACD) were measured 1wk, 1mo, and 3mo after phacoemulsification (PE) surgery.
RESULTS


The results indicated no statistically significant difference between the two groups in terms of predicted refractive error (obtained by subtracting preoperative predicted refractive error from actual postoperative refractive error) 1wk ( P =0.47), 1mo ( P= 0.30), and 3mo ( P =0.06) after the PE surgery. Regarding the CTR group, the changes of ACD was statistically significant 1 and 3mo after the PE surgery, compared to those obtained 1wk post-surgery ( P =0.005).
CONCLUSION


The CTR implantation in PEX cataractous patients without zonulysis has no statistically significant effect on the predicted refraction and ACD changes after PE. The predicted refraction error has a hyperopic shift in both groups. The results reveal the unnecessary of calculating modified IOL in CTR implantation.",2020,The CTR implantation in PEX cataractous patients without zonulysis has no statistically significant effect on the predicted refraction and ACD changes after PE.,"['patients with pseudoexfoliation syndrome', '60 patients with PEX syndrome referring to Imam Khomeini Hospital affiliated to Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran, for undergoing cataract surgery', 'patients with pseudoexfoliation (PEX) syndrome']","['capsular tension ring implantation', 'capsular tension ring (CTR) implantation']","['refractive error and anterior chamber depth (ACD', 'predicted refractive error', 'changes of ACD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206368', 'cui_str': 'Pseudoexfoliation glaucoma'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]","[{'cui': 'C1444765', 'cui_str': 'Capsular tension ring'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}, {'cui': 'C0429492', 'cui_str': 'Depth of anterior chamber'}, {'cui': 'C0002873', 'cui_str': 'Anemia of chronic disease'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",60.0,0.130662,The CTR implantation in PEX cataractous patients without zonulysis has no statistically significant effect on the predicted refraction and ACD changes after PE.,"[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Malekahmadi', 'Affiliation': 'Department of Ophthalmology, Infectious Ophthalmologic Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz 6193673111, Iran.'}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Kazemi', 'Affiliation': 'Department of Ophthalmology, Infectious Ophthalmologic Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz 6193673111, Iran.'}, {'ForeName': 'Farideh', 'Initials': 'F', 'LastName': 'Sharifipour', 'Affiliation': 'Department of Ophthalmology, Infectious Ophthalmologic Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz 6193673111, Iran.'}, {'ForeName': 'Farshad', 'Initials': 'F', 'LastName': 'Ostadian', 'Affiliation': 'Department of Ophthalmology, Infectious Ophthalmologic Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz 6193673111, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Mahdian Rad', 'Affiliation': 'Department of Ophthalmology, Infectious Ophthalmologic Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz 6193673111, Iran.'}, {'ForeName': 'Mohammad Sadegh', 'Initials': 'MS', 'LastName': 'Mirdehghan', 'Affiliation': 'Department of Ophthalmology, Infectious Ophthalmologic Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz 6193673111, Iran.'}]",International journal of ophthalmology,['10.18240/ijo.2020.04.09']
135,32399410,Pentacam changes in primary angle-closure glaucoma after different lines of treatment.,"AIM


To assess the changes in the anterior chamber parameters using Pentacam following four different lines of treatment of primary angle-closure glaucoma (PACG).
METHODS


A retrospective comparative study included 126 patients (126 eye) presented within 24-48h after acute angle-closure glaucoma (AACG). Patients were divided into 2 groups: group A (68 eyes) with controlled intraocular pressure (IOP) ≤21 mm Hg, which included subgroup A1 (34 eyes) with clear lens underwent Nd:YAG laser peripheral iridotomy (LPI) and subgroup A2 (34 eyes) with cataract underwent standard phacoemulsification; and group B (58 eyes) with uncontrolled IOP, which included subgroup B1 (30 eyes) with clear lens underwent trabeculectomy and subgroup B2 (28 eyes) with cataract underwent combined phacoemulsification and trabeculectomy. Patients were followed up for at least 3mo. Primary outcomes were Pentacam anterior segment measurements [anterior chamber angle (ACA) and depth (ACD)]. Secondary outcomes were changes in IOP, visual acuity (VA) and recorded complications.
RESULTS


At the 3 rd  month, there was significant increase in the ACA values in all studied groups compared to preoperative values ( P <0.001). The highest percent of increase in ACA was recorded in phacotrabeculectomy group B2 (128.40%). There was significant increase in ACD values at 3 rd  month compared with baseline values ( P <0.001) for groups A1, A2, and B2; without change in B1 trabeculectomy group. The maximum deepening of ACD was noticed in group B2 with 94.27% increase. Significant decrease in postoperative IOP in groups A2, B1 and B2 ( P <0.001,  P =0.014, and  P <0.001 respectively). In group A1 there was significant increase in 3 rd  month postoperative IOP from baseline values ( P <0.001). The maximum decrease in IOP was noticed in group B2 with 59.54% decrease. VA improvement in 3 rd  month postoperative was recorded in all studied groups, maximum VA improvement was observed in group B2 up to 0.2 logMAR.
CONCLUSION


Pentacam can be a helpful tool in studying and comparing the effect of the different lines of management of PACG on the anterior chamber measures. Phacotrabeculectomy was proved to be an effective line for managing PACG with resultant significant increase in the anterior chamber parameters, IOP reduction as well as maximum VA improvement. LPI has only temporary effect on IOP with significant changes in ACA and ACD. Phacoemuslification alone can be an option in treating PACG. Trabeculectomy resulted in temporary increase in the anterior chamber parameter which subsequently returned to baseline values.",2020,"Significant decrease in postoperative IOP in groups A2, B1 and B2 ( P <0.001,  P =0.014, and  P <0.001 respectively).","['primary angle-closure glaucoma (PACG', '126 patients (126 eye) presented within 24-48h after acute angle-closure glaucoma (AACG']","['LPI', 'Trabeculectomy', 'YAG laser peripheral iridotomy (LPI) and subgroup A2 (34 eyes) with cataract underwent standard phacoemulsification', 'uncontrolled IOP, which included subgroup B1 (30 eyes) with clear lens underwent trabeculectomy and subgroup B2 (28 eyes) with cataract underwent combined phacoemulsification and trabeculectomy', 'controlled intraocular pressure (IOP) ≤21 mm Hg, which included subgroup A1 (34 eyes) with clear lens underwent Nd']","['anterior chamber parameters, IOP reduction', 'changes in IOP, visual acuity (VA) and recorded complications', 'ACA values', 'ACD values', 'postoperative IOP', 'Pentacam anterior segment measurements [anterior chamber angle (ACA) and depth (ACD', 'anterior chamber parameter', 'maximum deepening of ACD', '3 rd  month postoperative IOP', 'ACA', 'IOP', 'maximum VA improvement']","[{'cui': 'C0017605', 'cui_str': 'Angle-closure glaucoma'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0154946', 'cui_str': 'Acute angle-closure glaucoma'}]","[{'cui': 'C0395459', 'cui_str': 'Laser iridotomy'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0587723', 'cui_str': 'YAG - laser'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0197497', 'cui_str': 'Anterior segment of eye incision'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0458088', 'cui_str': 'O/E - lens normal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003151', 'cui_str': 'Anterior chamber of eye structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0229238', 'cui_str': 'Structure of iridocorneal angle'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002873', 'cui_str': 'Anemia of chronic disease'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",126.0,0.0617764,"Significant decrease in postoperative IOP in groups A2, B1 and B2 ( P <0.001,  P =0.014, and  P <0.001 respectively).","[{'ForeName': 'Tharwat H', 'Initials': 'TH', 'LastName': 'Mokbel', 'Affiliation': 'Mansoura Ophthalmic Center, Faculty of Medicine, Mansoura University, Mansoura 35516, Egypt.'}, {'ForeName': 'Abd-Elmonem', 'Initials': 'AE', 'LastName': 'Elhesy', 'Affiliation': 'Mansoura Ophthalmic Center, Faculty of Medicine, Mansoura University, Mansoura 35516, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Alnagdy', 'Affiliation': 'Mansoura Ophthalmic Center, Faculty of Medicine, Mansoura University, Mansoura 35516, Egypt.'}, {'ForeName': 'Mohammed F', 'Initials': 'MF', 'LastName': 'Elashri', 'Affiliation': 'Department of Ophthalmology, Kafrelshiekh University, Kafr el-Shiekh 33516, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Eissa', 'Affiliation': 'Department of Ophthalmology, General Organization for Teaching Hospitals and Institutes, Cairo 11562, Egypt.'}, {'ForeName': 'Walid M', 'Initials': 'WM', 'LastName': 'Gaafar', 'Affiliation': 'Mansoura Ophthalmic Center, Faculty of Medicine, Mansoura University, Mansoura 35516, Egypt.'}, {'ForeName': 'Sherein M', 'Initials': 'SM', 'LastName': 'Hagras', 'Affiliation': 'Mansoura Ophthalmic Center, Faculty of Medicine, Mansoura University, Mansoura 35516, Egypt.'}]",International journal of ophthalmology,['10.18240/ijo.2020.04.10']
136,32399413,Anatomic and functional results of idiopathic macular epiretinal membrane surgery.,"AIM


To assess the impact of macular surgery on the functional and anatomic outcomes in patients with grade 2 epiretinal membrane (ERM), and the effect of internal limiting membrane (ILM) peeling on visual acuity and to analyze the long-term effect of pars plana vitrectomy (PPV) on intraocular pressure (IOP).
METHODS


Pseudophakic eyes (62 eyes) diagnosed as idiopathic grade 2 ERM with at least 6mo postoperative follow-up were included in this retrospective study. The fellow eye was nonvitrectomized. Patients were divided into two groups: group 1 (29 eyes) treated with ERM and ILM peeling and group 2 (33 eyes) with only ERM peeling. Preoperative and postoperative best corrected visual acuity (BCVA), slit-lamp, and a dilated fundus examination was performed. IOP was measured with Goldman applanation tonometer before, day 1 and first week and each visit after surgery. The incidence of significant IOP elevation was compared between vitrectomized eyes and nonvitrectomized fellow eyes.
RESULTS


Visual improvement was statistically significant and similar in both groups ( P =0.008 in group 1,  P =0.002 in group 2,  P =0.09 inter-group). The amount of decrease in central macular thickness was statistically significant and similar in both groups ( P =0.005 group 1,  P =0.008 group 2,  P =0.37 intergroup). At the final follow-up (14.1±9.6mo) the incidence of significant IOP elevation was 4% in vitrectomized eyes (three eyes) and 3% (two eyes) in the nonvitrectomized fellow eyes ( P =0.12). Four eyes (12.1%) had recurrent ERM after a mean follow-up of 8.6±1.1mo in group 2, there was no recurrence in group 1 ( P =0.01).
CONCLUSION


Recurrence of ERM may be decreased by ILM peeling during ERM surgery. However, it seems that ILM peeling do not affect the functional outcome and 23-gauge PPV alone do not have a significant effect on IOP.",2020,"The amount of decrease in central macular thickness was statistically significant and similar in both groups ( P =0.005 group 1,  P =0.008 group 2,  P =0.37 intergroup).","['patients with grade 2 epiretinal membrane (ERM', 'Pseudophakic eyes (62 eyes) diagnosed as idiopathic grade 2 ERM with at least 6mo postoperative follow-up', 'idiopathic macular epiretinal membrane surgery']","['pars plana vitrectomy (PPV', 'ERM and ILM peeling and group 2 (33 eyes) with only ERM peeling', 'internal limiting membrane (ILM) peeling', 'macular surgery']","['recurrent ERM', 'incidence of significant IOP elevation', 'central macular thickness', 'Recurrence of ERM', 'IOP', 'intraocular pressure (IOP', 'Preoperative and postoperative best corrected visual acuity (BCVA), slit-lamp, and a dilated fundus examination', 'Visual improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0183355', 'cui_str': 'Slit lamp biomicroscope'}, {'cui': 'C0700124', 'cui_str': 'Ectatic'}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",,0.0762792,"The amount of decrease in central macular thickness was statistically significant and similar in both groups ( P =0.005 group 1,  P =0.008 group 2,  P =0.37 intergroup).","[{'ForeName': 'Mehmet Ozgur', 'Initials': 'MO', 'LastName': 'Cubuk', 'Affiliation': 'Department of Ophthalmology, Istanbul Research and Education Hospital, Istanbul 34025, Turkey.'}, {'ForeName': 'Erkan', 'Initials': 'E', 'LastName': 'Unsal', 'Affiliation': 'Department of Ophthalmology, Istanbul Research and Education Hospital, Istanbul 34025, Turkey.'}]",International journal of ophthalmology,['10.18240/ijo.2020.04.13']
137,32399460,Cost Analysis of Biliary Drainage Using Metal versus Plastic Stents in Hepatocellular Carcinoma Patients with Obstructive Jaundice.,"Background


The optimal method of biliary drainage for biliary obstruction caused by hepatocellular carcinoma (HCC) is controversial, and the possible endoscopic application of plastic and metal stents is the least invasive procedure to improve patients' quality of life.
Aim


Our objective was to study cost evaluation based on a clinical efficacy of both procedures in a randomized trial comparing both approaches in patients with biliary obstruction caused by HCC.
Methods


The strategy of management was based on clinical effectiveness of biliary drainage with either metal or plastic stents in 90 patients over a 1-year follow-up period. Total (direct and indirect) costs were evaluated.
Results


The direct costs were EGP 40,857.84 and 21,802.62 per patient with plastic and metal stents, respectively. Concerning the indirect costs, EGP 888 and 454 were spent for each patient with plastic and metal stents, respectively. The differences in the costs resulted from patients with plastic stent insertion requiring more second endoscopic retrograde cholangiopancreatography procedures and more medication, medical consultation, and hospitalization during the year of follow-up.
Conclusions


Based on this analysis, the use of metal stents rather than plastic stents in biliary drainage is more cost effective for this group of patients.",2020,"The differences in the costs resulted from patients with plastic stent insertion requiring more second endoscopic retrograde cholangiopancreatography procedures and more medication, medical consultation, and hospitalization during the year of follow-up.
","['Hepatocellular Carcinoma Patients with Obstructive Jaundice', 'patients with biliary obstruction caused by HCC', 'biliary obstruction caused by hepatocellular carcinoma (HCC', 'patients with plastic stent insertion requiring more second endoscopic retrograde cholangiopancreatography procedures and more medication, medical consultation, and hospitalization during the year of follow-up', '90 patients over a 1-year follow-up period']","['Biliary Drainage Using Metal versus Plastic Stents', 'biliary drainage', 'biliary drainage with either metal or plastic stents']","['direct costs', 'Total (direct and indirect) costs']","[{'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022354', 'cui_str': 'Obstructive hyperbilirubinemia'}, {'cui': 'C0400979', 'cui_str': 'Obstruction of biliary tree'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0441289', 'cui_str': 'Plastic stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0400745', 'cui_str': 'Biliary drainage'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0441289', 'cui_str': 'Plastic stent'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}]",,0.072641,"The differences in the costs resulted from patients with plastic stent insertion requiring more second endoscopic retrograde cholangiopancreatography procedures and more medication, medical consultation, and hospitalization during the year of follow-up.
","[{'ForeName': 'Esam', 'Initials': 'E', 'LastName': 'Elshimi', 'Affiliation': 'Hepatology Department, National Liver Institute, Menoufia University, Shebin Al-Kom, Egypt.'}, {'ForeName': 'Wesam', 'Initials': 'W', 'LastName': 'Morad', 'Affiliation': 'Epidemiology and Preventive Medicine Department, National Liver Institute, Menoufia University, Shebin Al-Kom, Egypt.'}]",Gastrointestinal tumors,['10.1159/000503862']
138,32399492,Comparison of surgical cricothyroidotomy training: a randomized controlled trial of a swine model versus an animated robotic manikin model.,"Background


Airway obstruction remains a preventable cause of death on the battlefield. Surgical cricothyroidotomy is an essential skill for immediate airway management in trauma. Training for surgical cricothyroidotomy has been undertaken using simulators, cadavers or animal models. The ideal approach to training for this low volume and high-risk procedure is unknown. We hypothesized that current simulation technology provides an equal or better education for surgical cricothyroidotomy when compared with animal tissue training.
Methods


We performed a prospective randomized controlled study comparing training for surgical cricothyroidotomy using hands-on training on swine versus inanimate manikin. We enrolled medical students who had never performed or had formal instruction on surgical cricothyroidotomy. We randomized their instruction to use either a swine model or the inanimate version of the Operative Experience Inc. advanced surgical manikin. Participants' skills were then evaluated on human cadavers and on an advanced robotic manikin. Tests were scored using checklists modified from Objective Structured Assessment of Technical Skills and Tactical Combat Casualty Care. We compared scores between the groups using Wilcoxon rank sum tests and generalized linear models.
Results


Forty-eight participants were enrolled and trained; 30 participants completed the first testing session; 25 completed the second testing session. The mean time to establish an airway from the incision until the cuff was blown up was 95±52 s. There were no significant differences in any of the outcome measures between the two training groups.
Discussion


Measured performance was not different between subjects trained to perform surgical cricothyroidotomy on an animal model or a high fidelity manikin. The use of an advanced simulator has the potential to replace live tissue for this procedure mitigating concerns over animal rights.
Levels of evidence


I.",2020,"There were no significant differences in any of the outcome measures between the two training groups.
","['Forty-eight participants were enrolled and trained; 30 participants completed the first testing session; 25 completed the second testing session', 'enrolled medical students who had never performed or had formal instruction on surgical cricothyroidotomy']","['surgical cricothyroidotomy training', 'surgical cricothyroidotomy using hands-on training on swine versus inanimate manikin', 'swine model or the inanimate version of the Operative Experience Inc. advanced surgical manikin', 'Surgical cricothyroidotomy', 'animated robotic manikin model']",['mean time to establish an airway'],"[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0396636', 'cui_str': 'Open cricothyroidotomy'}]","[{'cui': 'C0396636', 'cui_str': 'Open cricothyroidotomy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]",48.0,0.027439,"There were no significant differences in any of the outcome measures between the two training groups.
","[{'ForeName': 'Vinciya', 'Initials': 'V', 'LastName': 'Pandian', 'Affiliation': 'Department of Nursing Faculty, Johns Hopkins School of Nursing, Baltimore, Maryland, United States.'}, {'ForeName': 'William Robert', 'Initials': 'WR', 'LastName': 'Leeper', 'Affiliation': 'Department of Surgery, London Health Sciences Centre, Victorial Hospital, London, Ontario, Canada.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Department of Surgery, Johns Hopkins School of Medicine, Baltimore, Maryland, United States.'}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'Pugh', 'Affiliation': 'Department of Surgery, Uniformed Services University of the Health Sciences, Bethesda, Maryland, United States.'}, {'ForeName': 'Gayane', 'Initials': 'G', 'LastName': 'Yenokyan', 'Affiliation': 'Department of Biostatistics, Johns Hopkins School of Public Health, Baltimore, Maryland, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bowyer', 'Affiliation': 'Department of Surgery, Uniformed Services University of the Health Sciences, Bethesda, Maryland, United States.'}, {'ForeName': 'Elliott R', 'Initials': 'ER', 'LastName': 'Haut', 'Affiliation': 'Department of Surgery, Johns Hopkins School of Medicine, Baltimore, Maryland, United States.'}]",Trauma surgery & acute care open,['10.1136/tsaco-2019-000431']
139,32399500,"Interleukin-2 Therapy of Autoimmunity in Diabetes (ITAD): a phase 2, multicentre, double-blind, randomized, placebo-controlled trial.","Type 1 diabetes is a common autoimmune disease due to destruction of pancreatic β cells, resulting in lifelong need for insulin. Evidence suggest that maintaining residual β-cell function can improve glucose control and reduce risk of hypoglycaemia and vascular complications. Non-clinical, preclinical and some preliminary clinical data suggest that low-dose interleukin-2 (IL-2) therapy could block pancreatic β cells destruction by increasing the number of functional regulatory T cells (Tregs) that inhibit islet-specific autoreactive effector T cells (Teffs). However, there is lack of data on the effect of low-dose IL-2 in newly diagnosed children and adolescents with T1D as well as lack of specific data on its potential effect on β-cell function. The '  I nterleukin-2  T herapy of  A utoimmunity in  D iabetes (ITAD)' is a phase 2, multicentre, double-blind, randomised, placebo-controlled trial in children and adolescents (6-18 years; having detectable C-peptide) initiated within 6 weeks of T1D diagnosis. A total of 45 participants will be randomised in a 2:1 ratio to receive either ultra-low dose IL-2 (aldesleukin), at a dose of 0.2 x 10  6  IU/m  2  twice-weekly, given subcutaneously, or placebo, for 6 months. The primary objective is to assess the effects of ultra-low dose aldesleukin administration on endogenous β-cell function as measured by frequent home dried blood spot (DBS) fasting and post-prandial C-peptide in children and adolescents with newly diagnosed T1D. The secondary objectives are: 1) to assess the efficacy of regular dosing of aldesleukin in increasing Treg levels; 2) to confirm the clinical safety and tolerability of ultra-low dose aldesleukin; 3) to assess changes in the immune system indicating benefit or potential risk for future gains/loss in β-cell function and immune function; 4) to assess treatment effect on glycaemic control. Trial registration: EudraCT 2017-002126-20 (06/02/2019).",2020,The '  I nterleukin-2  T herapy of  ,"['Autoimmunity in Diabetes (ITAD', 'children and adolescents (6-18 years; having detectable C-peptide) initiated within 6 weeks of T1D diagnosis', 'newly diagnosed children and adolescents with T1D', 'children and adolescents with newly diagnosed T1D', '45 participants']","['Interleukin-2 Therapy', 'ultra-low dose IL-2 (aldesleukin', 'aldesleukin', 'ultra-low dose aldesleukin', 'placebo']","['endogenous β-cell function', 'risk of hypoglycaemia and vascular complications']","[{'cui': 'C0004364', 'cui_str': 'Autoimmune disease'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0199975', 'cui_str': 'Interleukin-2 therapy'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0218986', 'cui_str': 'Aldesleukin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",45.0,0.644247,The '  I nterleukin-2  T herapy of  ,"[{'ForeName': 'M Loredana', 'Initials': 'ML', 'LastName': 'Marcovecchio', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Wicker', 'Affiliation': 'JDRF/Wellcome Diabetes and Inflammation Laboratory, Nuffield Department of Medicine, Wellcome Centre for Human Genetics, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, OX3 7BN, UK.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Dunger', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dutton', 'Affiliation': 'Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, OX3 7LD, UK.'}, {'ForeName': 'Sylwia', 'Initials': 'S', 'LastName': 'Kopijasz', 'Affiliation': 'JDRF/Wellcome Diabetes and Inflammation Laboratory, Nuffield Department of Medicine, Wellcome Centre for Human Genetics, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, OX3 7BN, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Scudder', 'Affiliation': 'JDRF/Wellcome Diabetes and Inflammation Laboratory, Nuffield Department of Medicine, Wellcome Centre for Human Genetics, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, OX3 7BN, UK.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Todd', 'Affiliation': 'JDRF/Wellcome Diabetes and Inflammation Laboratory, Nuffield Department of Medicine, Wellcome Centre for Human Genetics, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, OX3 7BN, UK.'}, {'ForeName': 'Paul R V', 'Initials': 'PRV', 'LastName': 'Johnson', 'Affiliation': 'Islet Transplant Research Group, Nuffield Department of Surgical Sciences, Centre for Diabetes, Endocrinology and Metabolism (OCDEM), University of Oxford, Oxford, OX3 9DU, UK.'}]",Wellcome open research,['10.12688/wellcomeopenres.15697.1']
140,32399752,Impact of the Bayesian penalized likelihood algorithm (Q.Clear®) in comparison with the OSEM reconstruction on low contrast PET hypoxic images.,"PURPOSE


To determine the impact of the Bayesian penalized likelihood (BPL) reconstruction algorithm in comparison to OSEM on hypoxia PET/CT images of NSCLC using  18 F-MIZO and  18 F-FAZA.
MATERIALS AND METHODS


Images of low-contrasted (SBR = 3) micro-spheres of Jaszczak phantom were acquired. Twenty patients with lung neoplasia were included. Each patient benefitted from  18 F-MISO and/or  18 F-FAZA PET/CT exams, reconstructed with OSEM and BPL. Lesion was considered as hypoxic if the lesion SUV max  > 1.4. A blind evaluation of lesion detectability and image quality was performed on a set of 78 randomized BPL and OSEM images by 10 nuclear physicians. SUV max , SUV mean,  and hypoxic volumes using 3 thresholding approaches were measured and compared for each reconstruction.
RESULTS


The phantom and patient datasets showed a significant increase of quantitative parameters using BPL compared to OSEM but had no impact on detectability. The optimal beta parameter determined by the phantom analysis was β350. Regarding patient data, there was no clear trend of image quality improvement using BPL. There was no correlation between SUV max  increase with BPL and either SUV or hypoxic volume from the initial OSEM reconstruction. Hypoxic volume obtained by a SUV > 1.4 thresholding was not impacted by the BPL reconstruction parameter.
CONCLUSION


BPL allows a significant increase in quantitative parameters and contrast without significantly improving the lesion detectability or image quality. The variation in hypoxic volume by BPL depends on the method used but SUV > 1.4 thresholding seems to be the more robust method, not impacted by the reconstruction method (BPL or OSEM).
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02490696. Registered 1 June 2015.",2020,The phantom and patient datasets showed a significant increase of quantitative parameters using BPL compared to OSEM but had no impact on detectability.,"['Twenty patients with lung neoplasia were included', 'Images of low-contrasted (SBR = 3) micro-spheres of Jaszczak phantom were acquired']","['Bayesian penalized likelihood algorithm (Q.Clear®', 'Bayesian penalized likelihood (BPL) reconstruction algorithm', 'OSEM']","['detectability', 'lesion detectability or image quality', 'Hypoxic volume', 'quantitative parameters', 'SUV max , SUV mean,  and hypoxic volumes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0282611', 'cui_str': 'Phantom'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",20.0,0.0261638,The phantom and patient datasets showed a significant increase of quantitative parameters using BPL compared to OSEM but had no impact on detectability.,"[{'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Texte', 'Affiliation': 'Nuclear Medicine Department, Henri Becquerel Cancer Center, Rouen, France.'}, {'ForeName': 'Pierrick', 'Initials': 'P', 'LastName': 'Gouel', 'Affiliation': 'Nuclear Medicine Department, Henri Becquerel Cancer Center, Rouen, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Thureau', 'Affiliation': 'QuantIF-LITIS EA4108, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Lequesne', 'Affiliation': 'Clinical Research Department, Henri Becquerel Cancer Center, Rouen, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Barres', 'Affiliation': 'Nuclear Medicine Department, Jean Perrin Cancer Center, Clermont-Ferrand, France.'}, {'ForeName': 'Agathe', 'Initials': 'A', 'LastName': 'Edet-Sanson', 'Affiliation': 'Nuclear Medicine Department, Henri Becquerel Cancer Center, Rouen, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Decazes', 'Affiliation': 'Nuclear Medicine Department, Henri Becquerel Cancer Center, Rouen, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Vera', 'Affiliation': 'Nuclear Medicine Department, Henri Becquerel Cancer Center, Rouen, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Hapdey', 'Affiliation': 'Nuclear Medicine Department, Henri Becquerel Cancer Center, Rouen, France. sebastien.hapdey@chb.unicancer.fr.'}]",EJNMMI physics,['10.1186/s40658-020-00300-3']
141,32399853,"Safety, Tolerability, and Pharmacokinetics of SUVN-G3031, a Novel Histamine-3 Receptor Inverse Agonist for the Treatment of Narcolepsy, in Healthy Human Subjects Following Single and Multiple Oral Doses.","BACKGROUND AND OBJECTIVE


SUVN-G3031 is a novel, potent, and selective histamine-3 receptor (H 3 R) inverse agonist in development for the treatment of narcolepsy. Our objective was to characterize the safety, tolerability, and pharmacokinetics of SUVN-G3031 in healthy young adults after single and multiple doses, and to evaluate the effect of food, gender, and age on the pharmacokinetics.
METHODS


A single ascending dose (SAD) and a multiple ascending dose (MAD) study for 14 days was conducted in healthy young adults using a randomized, double-blind study design. The effect of food, gender, and age on SUVN-G3031 pharmacokinetics (6 mg as a single dose) was evaluated using an open-label, two-period, randomized, crossover design in fed and fasted states. Pharmacokinetics and safety assessments were conducted throughout the study.
RESULTS


Single doses of SUVN-G3031 up to 20 mg and multiple doses up to 6 mg once daily were found to be safe and well tolerated in healthy young adults. The most frequently reported adverse events were abnormal dreams, dyssomnia, and hot flushes. SUVN-G3031 exposure was dose proportional across the tested doses. Steady state was achieved on day 6 after once-daily dosing. Renal excretion (~ 60%) of unchanged SUVN-G3031 was the major route of elimination. Food, gender, and age did not have any clinically meaningful effect on SUVN-G3031 exposure.
CONCLUSION


SUVN-G3031 was found to be safe and well tolerated in healthy human subjects without any effect of age, gender, and food on the pharmacokinetics and safety profile. Clinical Trials Registration (https://clinicaltrials.gov): NCT04072380 and NCT02342041.",2020,"SUVN-G3031 was found to be safe and well tolerated in healthy human subjects without any effect of age, gender, and food on the pharmacokinetics and safety profile.","['Healthy Human Subjects Following Single and Multiple Oral Doses', 'healthy human subjects', 'healthy young adults']",[],"['Renal excretion', 'safety, tolerability, and pharmacokinetics', 'Safety, Tolerability, and Pharmacokinetics', 'safe and well tolerated']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],"[{'cui': 'C1373187', 'cui_str': 'Renal Excretion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.0520693,"SUVN-G3031 was found to be safe and well tolerated in healthy human subjects without any effect of age, gender, and food on the pharmacokinetics and safety profile.","[{'ForeName': 'Ramakrishna', 'Initials': 'R', 'LastName': 'Nirogi', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India. nvsrk@suven.com.'}, {'ForeName': 'Koteshwara', 'Initials': 'K', 'LastName': 'Mudigonda', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Gopinadh', 'Initials': 'G', 'LastName': 'Bhyrapuneni', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Nageswara Rao', 'Initials': 'NR', 'LastName': 'Muddana', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Shinde', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Vinod Kumar', 'Initials': 'VK', 'LastName': 'Goyal', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Santosh Kumar', 'Initials': 'SK', 'LastName': 'Pandey', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Abdul Rasheed', 'Initials': 'AR', 'LastName': 'Mohammed', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Jyothsna', 'Initials': 'J', 'LastName': 'Ravula', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Jetta', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Veera Raghava Chowdary', 'Initials': 'VRC', 'LastName': 'Palacharla', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}]",Clinical drug investigation,['10.1007/s40261-020-00920-8']
142,32216456,"Long-term safety and efficacy of erenumab in patients with chronic migraine: Results from a 52-week, open-label extension study.","BACKGROUND


This study reports the long-term safety and efficacy of erenumab in chronic migraine patients.
METHODS


This was a 52-week open-label extension study of a 12-week double-blind treatment phase study. During the double-blind treatment phase, patients received placebo or once-monthly erenumab 70 mg or 140 mg. During the open-label treatment phase, the initial monthly dose was erenumab 70 mg. Following protocol amendment, patients continued to receive erenumab 70 mg if they had already completed their Week 28 visit, otherwise, patients switched from 70 mg to 140 mg; if enrolled after the amendment, patients received 140 mg monthly throughout.
RESULTS


In all, 451/609 (74.1%) enrolled patients completed the study. The exposure-adjusted patient incidence rate for any adverse event was 126.3/100 patient-years for the overall erenumab group. Overall, the adverse event profile was similar to that observed in the double-blind treatment phase. Adverse event incidence rates did not increase with long-term erenumab treatment compared with the double-blind treatment phase, and no new serious or treatment-emergent events were seen. Efficacy was sustained throughout the 52 weeks. Clinically significant reductions from double-blind treatment phase baseline (about half) were observed for monthly migraine days and migraine-specific medication days. Achievement of ≥50%, ≥75% and 100% reductions from the double-blind treatment phase baseline in monthly migraine days at Week 52 were reported by 59.0%, 33.2% and 8.9% of patients, respectively, for the combined dose group. A numerically greater benefit was observed with 140 mg compared with 70 mg at Weeks 40 and 52.
CONCLUSIONS


Sustained efficacy of long-term erenumab treatment in patients with chronic migraine is demonstrated, with safety results consistent with the known safety profile of erenumab and adverse event rates comparable to placebo adverse event rates in the double-blind treatment phase.
TRIAL REGISTRATION


This study is registered at ClinicalTrials.gov (NCT02174861).",2020,"Adverse event incidence rates did not increase with long-term erenumab treatment compared with the double-blind treatment phase, and no new serious or treatment-emergent events were seen.","['chronic migraine patients', 'patients with chronic migraine']","['placebo or once-monthly erenumab 70\u2009mg or 140\u2009mg', 'erenumab']","['adverse event profile', 'Adverse event incidence rates', 'Efficacy']","[{'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0585302', 'cui_str': 'Once monthly'}, {'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.411908,"Adverse event incidence rates did not increase with long-term erenumab treatment compared with the double-blind treatment phase, and no new serious or treatment-emergent events were seen.","[{'ForeName': 'Stewart J', 'Initials': 'SJ', 'LastName': 'Tepper', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Department of Neurology, Danish Headache Center, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Reuter', 'Affiliation': 'Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Jan Lewis', 'Initials': 'JL', 'LastName': 'Brandes', 'Affiliation': 'Nashville Neuroscience Group and Vanderbilt University Department of Neurology, Nashville, TN, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Doležil', 'Affiliation': 'Prague Headache Center DADO MEDICAL sro, Prague, Czech Republic.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Silberstein', 'Affiliation': 'Jefferson Headache Center, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Winner', 'Affiliation': 'Premiere Research Institute, Nova Southeastern University, West Palm Beach, FL, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Global Biostatistical Science, Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Sunfa', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'Global Development, Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Mikol', 'Affiliation': 'Global Development, Amgen Inc, Thousand Oaks, CA, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420912726']
143,32396519,"Efficacy of tofacitinib in reducing pain in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis.","OBJECTIVE


To describe the efficacy of tofacitinib in reducing pain in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS) in a post-hoc analysis of randomised controlled trials.
METHODS


Data were collected from patients in seven tofacitinib studies: six phase III (four RA, two PsA) and one phase II study (AS), and grouped into five analysis populations based on rheumatic disease diagnosis and category of prior inadequate response (IR) to treatment: conventional synthetic disease-modifying antirheumatic drugs-IR (RA and PsA), tumour necrosis factor inhibitors-IR (RA and PsA), or non-steroidal anti-inflammatory drugs-IR (AS). Only patients who received tofacitinib 5 or 10 mg twice daily or placebo were included. Pain assessments included: Patient's Assessment of Arthritis Pain, Short-Form Health Survey 36v2 Question (Q)7 and Bodily Pain domain, Ankylosing Spondylitis Quality of Life Q9 and Q14, EuroQol Five Dimensions Pain/Discomfort dimension and Bath Ankylosing Spondylitis Disease Activity Index Q2 and Q3. Data were reported to month 6 (placebo to month 3) in the RA and PsA populations, and week 12 (tofacitinib and placebo) in the AS population.
RESULTS


Overall, 3330 patients were included in this analysis. In the RA and PsA populations, pain improvements in tofacitinib-treated patients compared with placebo were observed at the earliest time point assessed and at month 3 (maintained to month 6). In the AS population, pain improvements compared with placebo were observed at week 12.
CONCLUSION


Tofacitinib was associated with rapid and sustained improvements across multiple pain measures in patients with inflammatory rheumatic musculoskeletal diseases.",2020,"In the RA and PsA populations, pain improvements in tofacitinib-treated patients compared with placebo were observed at the earliest time point assessed and at month 3 (maintained to month 6).","['patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis', 'patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS', 'patients with inflammatory rheumatic musculoskeletal diseases', 'Data were collected from patients in seven tofacitinib studies: six phase III (four RA, two PsA) and one phase II study (AS), and grouped into five analysis populations based on rheumatic disease diagnosis and category of prior inadequate response (IR) to treatment', '3330 patients were included in this analysis']","['tofacitinib 5 or 10 mg twice daily or placebo', 'conventional synthetic disease-modifying antirheumatic drugs-IR (RA and PsA), tumour necrosis factor inhibitors-IR (RA and PsA), or non-steroidal anti-inflammatory drugs-IR (AS', 'tofacitinib', 'placebo']","['multiple pain measures', 'pain improvements', ""Pain assessments included: Patient's Assessment of Arthritis Pain, Short-Form Health Survey 36v2 Question (Q)7 and Bodily Pain domain, Ankylosing Spondylitis Quality of Life Q9 and Q14, EuroQol Five Dimensions Pain/Discomfort dimension and Bath Ankylosing Spondylitis Disease Activity Index Q2 and Q3"", 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009326', 'cui_str': 'Collagen disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C1998004', 'cui_str': 'Bath ankylosing spondylitis disease activity index'}]",3330.0,0.247993,"In the RA and PsA populations, pain improvements in tofacitinib-treated patients compared with placebo were observed at the earliest time point assessed and at month 3 (maintained to month 6).","[{'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Ogdie', 'Affiliation': 'Division of Rheumatology, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'de Vlam', 'Affiliation': 'Department of Rheumatology, UZ Leuven, Leuven, Belgium.'}, {'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': 'Glasgow Biomedical Research Centre, Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Rheumatology Research Group, Swedish Medical Center and University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Baer', 'Affiliation': 'Baer Weinberg MPC, Scarborough, Ontario, Canada.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Lukic', 'Affiliation': 'Pfizer Inc, New York, New York, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gruben', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA David.Gruben@pfizer.com.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Kwok', 'Affiliation': 'Pfizer Inc, New York, New York, USA.'}, {'ForeName': 'Cunshan', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Ming-Ann', 'Initials': 'MA', 'LastName': 'Hsu', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Maniccia', 'Affiliation': 'Pfizer Inc, New York, New York, USA.'}]",RMD open,['10.1136/rmdopen-2019-001042']
144,32366577,The Influence of Baseline Diastolic Blood Pressure on the Effects of Intensive Blood Pressure Lowering on Cardiovascular Outcomes and All-Cause Mortality in Type 2 Diabetes.,"OBJECTIVE


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


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


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


In persons with T2DM, intensive SBP lowering decreased the risk of cardiovascular composite end point irrespective of baseline DBP in the setting of standard glycemic control. Hence, low baseline DBP should not be an impediment to intensive SBP lowering in patients with T2DM treated with guidelines recommending standard glycemic control.",2020,"The relation between the effect of the intensive SBP intervention and baseline DBP was similar between glycemic arms for the cardiovascular composite three-way interaction ( P  = 0.83).
","['Type 2 Diabetes', 'type 2 diabetes mellitus (T2DM']","['low baseline diastolic blood pressure (DBP', 'Intensive Blood Pressure Lowering', 'intensive SBP intervention', 'intensive systolic blood pressure (SBP) lowering', 'SBP control', 'SBP']","['cardiovascular events', 'risk of the cardiovascular composite (hazard ratio [HR', 'risk of cardiovascular composite', 'cardiovascular outcomes']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4274392', 'cui_str': 'Baseline diastolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0567952,"The relation between the effect of the intensive SBP intervention and baseline DBP was similar between glycemic arms for the cardiovascular composite three-way interaction ( P  = 0.83).
","[{'ForeName': 'Olesya L', 'Initials': 'OL', 'LastName': 'Ilkun', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'Division of Biostatistics, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Whelton', 'Affiliation': 'Tulane University School of Public Health and Tropical Medicine, New Orleans, LA.'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Wei', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Boucher', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Ambrosius', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Division of Nephrology, Stanford University School of Medicine, Palo Alto, CA.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Beddhu', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City, UT srinivasan.beddhu@hsc.utah.edu.'}]",Diabetes care,['10.2337/dc19-2047']
145,32379333,Association of Individual-Level Factors With Visual Outcomes in Optic Neuritis: Secondary Analysis of a Randomized Clinical Trial.,"Importance


Using corticosteroids to treat acute demyelinating optic neuritis has been identified as an area for shared decision-making. However, no analysis exists to support personalized shared decision-making that considers long- and short-term treatment benefits.
Objective


To develop models of individual-level visual outcomes for patients with optic neuritis.
Design, Setting, and Participants


This secondary analysis of the Optic Neuritis Treatment Trial (ONTT), a randomized clinical trial, was performed at 14 academic eye centers and 1 large community eye center. Adults aged 18 to 46 years with incident acute unilateral optic neuritis within 8 days of vision loss onset were included. Data were collected from July 1988 to June 1991, downloaded on October 15, 2018, and analyzed from January 24, 2019, to February 20, 2020, using multivariable linear regression modeling.
Exposures


Intravenous corticosteroids vs placebo.
Main Outcomes and Measures


Visual acuity (VA) at 1 year. Secondary outcomes were 1-year contrast sensitivity (CS) and VA and CS at 15 and 30 days. Independent variables included age, sex, race, multiple sclerosis status, optic neuritis episodes in the fellow eye, vision symptoms (days), pain, optic disc swelling, viral illness, treatment group, and baseline VA or CS.
Results


Of the 455 participants, median age was 31.8 (interquartile range [IQR], 26.3-37.0) years; 350 (76.9%) were women; and 388 (85.3%) were white. For 410 participants (90.1%) with 1-year outcomes, median VA improved from 20/66 (IQR, 20/28-20/630) at enrollment to 20/17 (IQR, 20/14-20/21) at 1 year. Baseline VA was the primary variable associated with 1-year VA (regression coefficient, 0.056 [95% CI, 0.008-0.103]; P = .02) if baseline VA was better than count fingers (CF). At 15 days, baseline VA and treatment status were associated with VA in those participants with baseline VA better than CF (regression coefficient, 0.305 [95% CI, 0.231-0.380]; F = 9.42; P < .001). However, the difference of medians (20/18 [95% CI, 20/17-20/19] with intravenous corticosteroids vs 20/23 [95% CI, 20/21-20/26] with placebo) was small for the median VA (20/66) in the trial. Treatment was not associated with 15-day or 1-year VA in participants with baseline VA of CF or worse.
Conclusions and Relevance


In this study, long-term VA was associated with severity of baseline vision loss. Early benefits with intravenous corticosteroid treatment were limited to participants with baseline VA better than CF. However, the early, temporary benefit of intravenous corticosteroids is of questionable clinical significance and should be weighed against potential harms.",2020,"Treatment was not associated with 15-day or 1-year VA in participants with baseline VA of CF or worse.
","['14 academic eye centers and 1 large community eye center', '455 participants', ' median age was 31.8 (interquartile range [IQR], 26.3-37.0) years; 350 (76.9%) were women; and 388 (85.3%) were white', 'Adults aged 18 to 46 years with incident acute unilateral optic neuritis within 8 days of vision loss onset were included', 'Data were collected from July 1988 to June 1991, downloaded on October 15, 2018, and analyzed from January 24, 2019, to February 20, 2020, using multivariable linear regression modeling', 'patients with optic neuritis', 'Optic Neuritis']","['corticosteroids vs placebo', 'corticosteroids', 'intravenous corticosteroid', 'placebo']","['Measures\n\n\nVisual acuity (VA', '1-year contrast sensitivity (CS) and VA and CS', 'severity of baseline vision loss', 'fellow eye, vision symptoms (days), pain, optic disc swelling, viral illness', 'median VA']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517668', 'cui_str': '26.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0029134', 'cui_str': 'Optic neuritis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023733', 'cui_str': 'Linear Regression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0029127', 'cui_str': 'Optic disc structure'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.653426,"Treatment was not associated with 15-day or 1-year VA in participants with baseline VA of CF or worse.
","[{'ForeName': 'Lindsey B', 'Initials': 'LB', 'LastName': 'De Lott', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Burke', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Andrews', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Costello', 'Affiliation': 'Section of Ophthalmology, Department of Clinical Neurosciences and Surgery, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Wayne T', 'Initials': 'WT', 'LastName': 'Cornblath', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Trobe', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor.'}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Kerber', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.4339']
146,32375747,Two faces of the same coin: a qualitative study of patients' and carers' coexistence with chronic breathlessness associated with chronic obstructive pulmonary disease (COPD).,"BACKGROUND


Chronic breathlessness is a recognized clinical syndrome that severely impacts patients and carers, who become increasingly restricted in their daily activities. Often, patients become reliant on their carers, who are required to provide constant support. Although individual experiences of breathlessness have been previously investigated, there are few studies exploring contemporaneous experiences of breathlessness of the patient and their carer. This study aimed to understand the experience of severe chronic breathlessness in people with chronic obstructive pulmonary disease (COPD) from the perspective of the patient and carer unit.
METHODS


A qualitative study embedded in a randomised, placebo-controlled effectiveness study (RCT) of regular, low-dose (≤32 mg/day), sustained-release morphine for chronic breathlessness associated with COPD. Recruitment occurred between July 2017 and November 2018 in one respiratory and palliative care services, in South Australia. Participants were community-dwelling patients with COPD and severe breathlessness (modified Medical Research Council scale 3 or 4) and their carers. Separate semi-structured interviews were conducted with patients and carers, recorded and transcribed verbatim. Analysis was informed by grounded theory using a constant comparative approach.
RESULTS


From the 26 patients with a carer recruited for the RCT in South Australia, nine were interviewed in their homes. Six patients were men, median age 77 years. Carers were mostly women, who were their wives (n = 6), median age 70. Five themes emerged from the data: (1) shrinking world; (2) mutual adaptation; (3) co-management; (4) emotional coping; and (5) meaning in the face of death.
CONCLUSION


Chronic breathlessness is a systemic condition that permeates all aspects of the patient's and carer's lives. Working as a team, patients and carers manage chronic breathlessness to achieve maximal function and well-being. Patients and carers share many aspects of the experience of breathlessness, but the carer seems particularly susceptible to emotional distress. Future chronic breathlessness interventions should target the patient and the carer, both together and separately to address their common and individual needs.
TRIAL REGISTRATION


The main trial is registered (registration no. NCT02720822; posted March 28, 2016).",2020,Chronic breathlessness is a systemic condition that permeates all aspects of the patient's and carer's lives.,"['people with chronic obstructive pulmonary disease (COPD', 'Carers were mostly women, who were their wives (n\u2009=\u20096), median age 70', '26 patients with a carer recruited for the RCT in South Australia, nine were interviewed in their homes', 'Six patients were men, median age 77\u2009years', 'Participants were community-dwelling patients with COPD and severe breathlessness (modified Medical Research Council scale 3 or 4) and their carers', 'chronic breathlessness associated with COPD', ""patients' and carers' coexistence with chronic breathlessness associated with chronic obstructive pulmonary disease (COPD""]","['morphine', 'placebo']","['severe chronic breathlessness', 'emotional coping; and (5) meaning in the face of death', 'Chronic breathlessness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0037715', 'cui_str': 'South Australia'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",6.0,0.0887898,Chronic breathlessness is a systemic condition that permeates all aspects of the patient's and carer's lives.,"[{'ForeName': 'Diana H', 'Initials': 'DH', 'LastName': 'Ferreira', 'Affiliation': 'Discipline, Palliative and Supportive Services, Flinders University, GPO Box 2100, Adelaide, SA, 5001, Australia. diana.mbhf@gmail.com.'}, {'ForeName': 'Slavica', 'Initials': 'S', 'LastName': 'Kochovska', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, 2007, Australia.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Honson', 'Affiliation': 'Discipline, Palliative and Supportive Services, Flinders University, GPO Box 2100, Adelaide, SA, 5001, Australia.'}, {'ForeName': 'Jane L', 'Initials': 'JL', 'LastName': 'Phillips', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, 2007, Australia.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Currow', 'Affiliation': 'Discipline, Palliative and Supportive Services, Flinders University, GPO Box 2100, Adelaide, SA, 5001, Australia.'}]",BMC palliative care,['10.1186/s12904-020-00572-7']
147,32375754,Evaluation of an internet-based intervention for service members of the German armed forces with deployment-related posttraumatic stress symptoms.,"BACKGROUND


The present study was designed to evaluate the efficacy of a therapist-guided internet-based cognitive-behavioral therapy (iCBT) intervention for service members of the German Armed Forces with posttraumatic stress disorder (PTSD). The iCBT was adapted from Interapy, a trauma-focused evidence-based treatment based on prolonged exposure and cognitive restructuring. It lasted for 5 weeks and included 10 writing assignments (twice a week). The program included a reminder function if assignments were overdue, but no multimedia elements. Therapeutic written feedback was provided asynchronously within one working day.
METHODS


Male active and former military service members were recruited from the German Armed Forces. Diagnoses were assessed with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and the Mini-International Neuropsychiatric Interview. Psychopathology was assessed at pre-treatment, post-treatment, and 3-month follow-up. Severity of PTSD was the primary outcome and anxiety was the secondary outcome. Participants were randomly allocated to a treatment group that received iCBT immediately or to a waitlist group that received iCBT after 6 weeks. Due to the overall small sample size (n = 37), the two groups were collapsed for the statistical analyses. Change during the intervention period was investigated using latent-change score models.
RESULTS


Improvements in the CAPS-5 were small and not statistically significant. For anxiety, small significant improvements were observed from pre- to follow-up assessment. The dropout rate was 32.3%.
CONCLUSIONS


The low treatment utilization and the high dropout rate are in line with previous findings on treatment of service members. The interpretation of the current null results for the efficacy of iCBT is limited due to the small sample size, however for military samples effect estimates were also smaller in other recent studies. Our results demonstrate the need to identify factors influencing treatment engagement and efficacy in veterans.
TRIAL REGISTRATION


Australian Clinical Trials Registry ACTRN12616000956404.",2020,Participants were randomly allocated to a treatment group that received iCBT immediately or to a waitlist group that received iCBT after 6 weeks.,"['Male active and former military service members were recruited from the German Armed Forces', 'service members of the German Armed Forces with posttraumatic stress disorder (PTSD', 'service members of the German armed forces with deployment-related posttraumatic stress symptoms']","['iCBT immediately or to a waitlist group that received iCBT', 'iCBT', 'internet-based intervention', 'therapist-guided internet-based cognitive-behavioral therapy (iCBT) intervention']","['Clinician-Administered PTSD Scale for DSM-5 (CAPS-5', 'Psychopathology', 'dropout rate']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0336524', 'cui_str': 'Military services member'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}]",,0.0412261,Participants were randomly allocated to a treatment group that received iCBT immediately or to a waitlist group that received iCBT after 6 weeks.,"[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Niemeyer', 'Affiliation': 'Division of Clinical Psychological Intervention, Department of Education and Psychology, Freie Universität Berlin, Freie Universität Berlin, Schwendenerstr. 27, 14195, Berlin, Germany. hniemeyer@zedat.fu-berlin.de.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Knaevelsrud', 'Affiliation': 'Division of Clinical Psychological Intervention, Department of Education and Psychology, Freie Universität Berlin, Freie Universität Berlin, Schwendenerstr. 27, 14195, Berlin, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Schumacher', 'Affiliation': 'Division of Clinical Psychological Intervention, Department of Education and Psychology, Freie Universität Berlin, Freie Universität Berlin, Schwendenerstr. 27, 14195, Berlin, Germany.'}, {'ForeName': 'Sinha', 'Initials': 'S', 'LastName': 'Engel', 'Affiliation': 'Division of Clinical Psychological Intervention, Department of Education and Psychology, Freie Universität Berlin, Freie Universität Berlin, Schwendenerstr. 27, 14195, Berlin, Germany.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Kuester', 'Affiliation': 'Division of Clinical Psychological Intervention, Department of Education and Psychology, Freie Universität Berlin, Freie Universität Berlin, Schwendenerstr. 27, 14195, Berlin, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Burchert', 'Affiliation': 'Division of Clinical Psychological Intervention, Department of Education and Psychology, Freie Universität Berlin, Freie Universität Berlin, Schwendenerstr. 27, 14195, Berlin, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Muschalla', 'Affiliation': 'Department of Clinical Psychology, Psychotherapy and Diagnostics, Institute of Psychology, Technische Universität Braunschweig, Braunschweig, Germany.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Weiss', 'Affiliation': 'Division of Clinical Psychological Intervention, Department of Education and Psychology, Freie Universität Berlin, Freie Universität Berlin, Schwendenerstr. 27, 14195, Berlin, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Spies', 'Affiliation': 'Division of Clinical Psychological Intervention, Department of Education and Psychology, Freie Universität Berlin, Freie Universität Berlin, Schwendenerstr. 27, 14195, Berlin, Germany.'}, {'ForeName': 'Heinrich', 'Initials': 'H', 'LastName': 'Rau', 'Affiliation': 'German Armed Forces, Military Hospital Berlin, Department for Military Mental Health, Berlin, Germany.'}, {'ForeName': 'Gerd-Dieter', 'Initials': 'GD', 'LastName': 'Willmund', 'Affiliation': 'German Armed Forces, Military Hospital Berlin, Department for Military Mental Health, Berlin, Germany.'}]",BMC psychiatry,['10.1186/s12888-020-02595-z']
148,32376754,"Prospective, single-centre, randomised controlled trial to evaluate the efficacy and safety of ischaemia-free liver transplantation (IFLT) in the treatment of end-stage liver disease.","INTRODUCTION


During conventional liver transplantation (CLT), ischaemia-reperfusion injury (IRI) is inevitable and is associated with complications such as early allograft dysfunction (EAD), primary non-function and ischaemic-type biliary lesions. We have established a novel procedure called ischaemia-free liver transplantation (IFLT). The results from a pilot study suggest that IFLT might prevent IRI and yield better transplant outcomes than CLT. The purpose of this study was to further assess the efficacy and safety of IFLT versus CLT in patients with end-stage liver disease.
METHODS AND ANALYSIS


This is an investigator-initiated, open-label, phase III, prospective, single-centre randomised controlled trial on the effects of IFLT in patients with end-stage liver disease. Adult patients (aged 18-75 years) eligible for liver transplantation will be screened for participation in this trial and will be randomised between the IFLT group (n=34) and the CLT group (n=34). In the IFLT group, the donor liver will be procured, preserved and implanted with continuous normothermic machine perfusion (NMP). In the CLT group, the donor liver will be procured after a fast cold flush, preserved in 0°C-4°C solution and implanted under hypothermic and hypoxic conditions. Patients in both groups will be managed according to the standard protocol of our centre. The primary end point is the incidence of EAD after liver transplantation. Intraoperative and postoperative parameters of donor livers and recipients will be observed and recorded, and postoperative liver graft function, complications and recipient and graft survival will be evaluated. After a 12-month follow-up of the last enrolled recipient, the outcomes will be analysed to evaluate the safety and efficacy of IFLT versus CLT in patients with end-stage liver disease.
ETHICS AND DISSEMINATION


The protocol was reviewed and approved by the Ethics Committee of The First Affiliated Hospital of Sun Yat-sen University. The findings will be disseminated to the public through conference presentations and peer-reviewed scientific journals.
TRIAL REGISTRATION NUMBER


ChiCTR1900021158.",2020,"After a 12-month follow-up of the last enrolled recipient, the outcomes will be analysed to evaluate the safety and efficacy of IFLT versus CLT in patients with end-stage liver disease.
","['patients with end-stage liver disease', 'end-stage liver disease', 'Adult patients (aged 18-75 years) eligible for liver transplantation']","['CLT', 'ischaemia-free liver transplantation (IFLT', 'IFLT', 'IFLT versus CLT', 'conventional liver transplantation (CLT), ischaemia-reperfusion injury (IRI']","['efficacy and safety', 'safety and efficacy', 'incidence of EAD after liver transplantation', 'postoperative liver graft function, complications and recipient and graft survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0745744', 'cui_str': 'End stage liver disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-reperfusion injury'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}]",,0.0805885,"After a 12-month follow-up of the last enrolled recipient, the outcomes will be analysed to evaluate the safety and efficacy of IFLT versus CLT in patients with end-stage liver disease.
","[{'ForeName': 'Changjun', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Shanzhou', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yunhua', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Dongping', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Weiqiang', 'Initials': 'W', 'LastName': 'Ju', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Linwei', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Maogen', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhiheng', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zebin', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Linhe', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Caihui', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yixi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Chengjun', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiong', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yuekun', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xiaoxiang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Anbin', 'Initials': 'A', 'LastName': 'Hu', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Rong', 'Affiliation': 'Department of Cardiopulmonary Bypass, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Changjie', 'Initials': 'C', 'LastName': 'Cai', 'Affiliation': 'Surgical Intensive Care Unit, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China gdtrc@163.com rockyucsf1981@126.com.'}, {'ForeName': 'Xiaoshun', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China gdtrc@163.com rockyucsf1981@126.com.'}]",BMJ open,['10.1136/bmjopen-2019-035374']
149,32380132,Is a two-step impression mandatory for complete denture fabrication on the severely resorbed mandible? A randomized trial on patient perception and denture quality.,"OBJECTIVES


To evaluate the effectiveness of CCDs produced by two impression procedures for the mandibular ridge, in patients with severe mandibular atrophy.
METHODS


Fifty-two completely edentulous patients with severely resorbed mandibles were randomly allocated into two groups according to the impression procedure of the mandibular ridge: SI - single impression (stock tray and irreversible hydrocolloid); TI - two-step impression (custom tray, border molding with compound, and polyether). Assessments of oral health related quality of life (OHRQoL, primary outcome) and denture satisfaction were performed by using validated questionnaires. Denture quality was evaluated by means of functional tests.
RESULTS


Regardless of the technique, participants reported better OHRQoL (P < 0.001) in both follow-up periods (3 and 6 months after denture delivery), and groups resulted in similar OHIP-EDENT scores in its different domains (P > 0.05). Between-group differences were insignificant for general satisfaction (3 months, P = 0.699, 6 months, P = 0.392), as well as for aspects such as esthetics, comfort, mastication, speech, and prosthesis retention (P > 0.05). Overall clinical quality of the CCDs (P = 0.383) was similar between-group, as well as in specific aspects - interocclusal distance, occlusion, articulation, retention of the maxillary denture, and stability of both maxillary and mandibular dentures (P > 0.05).
CONCLUSIONS


Mandibular CCDs based on a single impression technique showed quality levels comparable to those generated by a two-step impression, both from the patient and clinician perspective.
CLINICAL SIGNIFICANCE


A simplified impression technique which eliminates the secondary impression can provide CCDs of good clinical quality, which influences the OHRQoL, and satisfaction in the same extent they would by a two-step procedure, even for patients with severely reabsorbed mandibular ridges. (ClinicalTrials.gov: NCT02339194).",2020,"Regardless of the technique, participants reported better OHRQoL","['patients with severely reabsorbed mandibular ridges', 'patients with severe mandibular atrophy.\nMETHODS\n\n\nFifty-two completely edentulous patients with severely resorbed mandibles']","['impression procedure of the mandibular ridge: SI - single impression (stock tray and irreversible hydrocolloid); TI - two-step impression (custom tray, border molding with compound, and polyether', 'CCDs']","['patient perception and denture quality', 'oral health related quality of life (OHRQoL, primary outcome) and denture satisfaction', 'specific aspects - interocclusal distance, occlusion, articulation, retention of the maxillary denture, and stability of both maxillary and mandibular dentures', 'Overall clinical quality of the CCDs', 'quality levels', 'Denture quality', 'general satisfaction', 'OHRQoL', 'similar OHIP-EDENT scores', 'esthetics, comfort, mastication, speech, and prosthesis retention']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0453908', 'cui_str': 'Stocking'}, {'cui': 'C0184054', 'cui_str': 'Tray'}, {'cui': 'C0020266', 'cui_str': 'Hydrocolloid'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0426103', 'cui_str': 'Fetal head molding'}, {'cui': 'C0205198', 'cui_str': 'Compound'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C3178965', 'cui_str': 'Prosthesis Retention'}]",52.0,0.0541727,"Regardless of the technique, participants reported better OHRQoL","[{'ForeName': 'Ivo S', 'Initials': 'IS', 'LastName': 'Albuquerque', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Alexandre Baraúna St. 949, Rodolfo Teófilo, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Rômulo R', 'Initials': 'RR', 'LastName': 'Regis', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Alexandre Baraúna St. 949, Rodolfo Teófilo, Fortaleza, Ceará, Brazil. Electronic address: romuloregis@hotmail.com.'}, {'ForeName': 'Raphael F', 'Initials': 'RF', 'LastName': 'de Souza', 'Affiliation': 'Oral Health and Society, Faculty of Dentistry, McGill University, 2001 McGill College Ave, Suite 500, Montreal, Quebec. Canada.'}, {'ForeName': 'Kelvin F', 'Initials': 'KF', 'LastName': 'Gurgel', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Alexandre Baraúna St. 949, Rodolfo Teófilo, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Paulo Gb', 'Initials': 'PG', 'LastName': 'Silva', 'Affiliation': 'Department of Dental Clinic, Division of Oral Pathology, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará (FFOE-UFC), Fortaleza, Brazil.'}, {'ForeName': 'Livia M S', 'Initials': 'LMS', 'LastName': 'Pinto-Fiamengui', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Alexandre Baraúna St. 949, Rodolfo Teófilo, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Karina M', 'Initials': 'KM', 'LastName': 'Freitas-Pontes', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Alexandre Baraúna St. 949, Rodolfo Teófilo, Fortaleza, Ceará, Brazil.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103356']
150,32380509,Role of feeding strategy bundle with acid-suppressive therapy in infants with esophageal acid reflux exposure: a randomized controlled trial.,"OBJECTIVE


To test the hypothesis that a feeding bundle concurrent with acid suppression is superior to acid suppression alone in improving gastroesophageal reflux disease (GERD) attributed-symptom scores and feeding outcomes in neonatal ICU infants.
METHODS


Infants (N = 76) between 34 and 60 weeks' postmenstrual age with acid reflux index > 3% were randomly allocated to study (acid-suppressive therapy + feeding bundle) or conventional (acid-suppressive therapy only) arms for 4 weeks. Feeding bundle included: total fluid volume < 140 mL/kg/day, fed over 30 min in right lateral position, and supine postprandial position. Primary outcome was independent oral feeding and/or ≥6-point decrease in symptom score (I-GERQ-R). Secondary outcomes included growth (weight, length, head circumference), length of hospital stay (LOHS, days), airway (oxygen at discharge), and developmental (Bayley scores) milestones.
RESULTS


Of 688 screened: 76 infants were randomized and used for the primary outcome as intent-to-treat, and secondary outcomes analyzed for 72 infants (N = 35 conventional, N = 37 study). For study vs. conventional groups, respectively: (a) 33% (95% CI, 19-49%) vs. 44% (95% CI, 28-62%), P = 0.28 achieved primary outcome success, and (b) secondary outcomes did not significantly differ (P > 0.05).
CONCLUSIONS


Feeding strategy modifications concurrent with acid suppression are not superior to PPI alone in improving GERD symptoms or discharge feeding, short-term and long-term outcomes.
IMPACT


Conservative feeding therapies are thought to modify GERD symptoms and its consequences. However, in this randomized controlled trial in convalescing neonatal ICU infants with GERD symptoms, when controlling for preterm or full-term birth and severity of esophageal acid reflux index, the effectiveness of acid suppression plus a feeding modification bundle (volume restriction, intra- and postprandial body positions, and prolonged feeding periods) vs. acid suppression alone, administered over a 4-week period was not superior in improving symptom scores or feeding outcomes.Restrictive feeding strategies are of no impact in modifying GERD symptoms or clinically meaningful outcomes. Further studies are needed to define true GERD and to identify effective therapies in modifying pathophysiology and outcomes.The improvement in symptoms and feeding outcomes over time irrespective of feeding modifications may suggest a maturational effect. This study justifies the use of placebo-controlled randomized clinical trial among NICU infants with objectively defined GERD.",2020,"CONCLUSIONS


Feeding strategy modifications concurrent with acid suppression are not superior to PPI alone in improving GERD symptoms or discharge feeding, short-term and long-term outcomes.
","['neonatal ICU infants', '72 infants (N\u2009=\u200935 conventional, N\u2009=\u200937 study', 'infants with esophageal acid reflux exposure', 'Of 688 screened: 76 infants', 'NICU infants with objectively defined GERD', ""Infants (N\u2009=\u200976) between 34 and 60 weeks' postmenstrual age with acid reflux index\u2009>\u20093"", 'convalescing neonatal ICU infants with GERD symptoms']","['study (acid-suppressive therapy\u2009+\u2009feeding bundle) or conventional (acid-suppressive therapy', 'Feeding bundle included: total fluid volume\u2009<\u2009140\u2009mL/kg/day, fed over 30\u2009min in right lateral position, and supine postprandial position', 'acid-suppressive therapy', 'placebo']","['oral feeding and/or ≥6-point decrease in symptom score (I-GERQ-R', 'growth (weight, length, head circumference), length of hospital stay (LOHS, days), airway (oxygen at discharge), and developmental (Bayley scores) milestones']","[{'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0856449', 'cui_str': 'Acid reflux (oesophageal)'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0205367', 'cui_str': 'Suppressive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449971', 'cui_str': 'Volume of fluid used'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C1532579', 'cui_str': 'mL/kg/day'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0559228', 'cui_str': 'Right lateral decubitus position'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}]",76.0,0.114882,"CONCLUSIONS


Feeding strategy modifications concurrent with acid suppression are not superior to PPI alone in improving GERD symptoms or discharge feeding, short-term and long-term outcomes.
","[{'ForeName': 'Sudarshan R', 'Initials': 'SR', 'LastName': 'Jadcherla', 'Affiliation': ""Innovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, OH, USA. Sudarshan.Jadcherla@nationwidechildrens.org.""}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Hasenstab', 'Affiliation': ""Innovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Lai', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Center for Biostatistics, Department of Biomedical Informatics, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Erika K', 'Initials': 'EK', 'LastName': 'Osborn', 'Affiliation': ""Innovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Sreekanth', 'Initials': 'S', 'LastName': 'Viswanathan', 'Affiliation': ""Innovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Ish K', 'Initials': 'IK', 'LastName': 'Gulati', 'Affiliation': ""Innovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Slaughter', 'Affiliation': ""Center for Perinatal Research, Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Di Lorenzo', 'Affiliation': 'Department of Pediatrics, College of Medicine, The Ohio State University College of Medicine, Columbus, OH, USA.'}]",Pediatric research,['10.1038/s41390-020-0932-4']
151,31233972,Stigma towards people who use drugs: A case vignette study in methadone maintenance treatment clinics in China.,"BACKGROUND


Drug use stigma among service providers has been recognized as a barrier to improving the accessibility and outcomes of addiction treatment. This study examined the stigmatizing attitudes towards people who use drugs (PWUD) among service providers in methadone maintenance treatment (MMT) clinics in China and its associated factors.
METHODS


The cross-sectional study used the baseline data of a randomized intervention trial conducted in China, and the data were collected from January 2012 to August 2013. A total of 418 MMT service providers were included in the study. Stigma towards PWUD was measured via a 10-item scale embedded in two case vignettes (PWUD and non-PWUD). The Wilcoxon signed-rank test was performed to evaluate the vignette difference for each item of the scale. The linear mixed model was used to identify the adjusted association between drug use stigma and other interested variables including demographics, professional background, and MMT knowledge of the service providers.
RESULTS


The Wilcoxon signed-rank tests showed that the participants had a higher level of stigmatizing attitudes towards PWUD than non-PWUD (p-value<0.001 for all items of the stigma scale). The linear mixed model identified that the reception of national MMT training was associated with a lower degree of drug use stigma (estimate=-1.79; 95% CI: -3.13, -0.45; p-value = 0.009).
CONCLUSION


The findings of the study provide evidence of the existence of drug use stigma among MMT providers in China. The expansion of national-level training and the development of stigma reduction interventions are needed to address this issue.",2019,The Wilcoxon signed-rank tests showed that the participants had a higher level of stigmatizing attitudes towards PWUD than non-PWUD (p-value<0.001 for all items of the stigma scale).,"['MMT providers in China', '418 MMT service providers were included in the study', 'China, and the data were collected from January 2012 to August 2013', 'stigmatizing attitudes towards people who use drugs (PWUD) among service providers in methadone maintenance treatment (MMT) clinics in China and its associated factors', 'methadone maintenance treatment clinics in China']",[],['Stigma towards PWUD'],"[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0588202', 'cui_str': 'Drug addiction therapy - methadone'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]",[],"[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}]",,0.0364637,The Wilcoxon signed-rank tests showed that the participants had a higher level of stigmatizing attitudes towards PWUD than non-PWUD (p-value<0.001 for all items of the stigma scale).,"[{'ForeName': 'Sitong', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, Center for Community Health, University of California, Los Angeles, 10920 Wilshire Blvd., Suite 350, Los Angeles, CA 90024, USA. Electronic address: sitongluo@ucla.edu.'}, {'ForeName': 'Chunqing', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, Center for Community Health, University of California, Los Angeles, 10920 Wilshire Blvd., Suite 350, Los Angeles, CA 90024, USA. Electronic address: lincq@ucla.edu.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Feng', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, Center for Community Health, University of California, Los Angeles, 10920 Wilshire Blvd., Suite 350, Los Angeles, CA 90024, USA. Electronic address: NFeng@mednet.ucla.edu.'}, {'ForeName': 'Zunyou', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, 155 Changbai Road, Changping District, Beijing, 102206, China. Electronic address: wuzunyou@chinaaids.cn.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, Center for Community Health, University of California, Los Angeles, 10920 Wilshire Blvd., Suite 350, Los Angeles, CA 90024, USA. Electronic address: lililili@ucla.edu.'}]",The International journal on drug policy,['10.1016/j.drugpo.2019.06.005']
152,30778865,Estimating Quality of Life Decrements Due to Diabetes Complications in the United States: The Health Utility Index (HUI) Diabetes Complication Equation.,"OBJECTIVE


Health utility decrements associated with diabetes mellitus complications are essential for calculating quality-adjusted life-years (QALYs) in patients for use in economic evaluation of diabetes interventions. Previous studies mostly focused on assessing the impact of complications on health utility at event year based on cross-sectional data. This study aimed to separately estimate health utility decrements associated with current and previous diabetes complications.
RESEARCH DESIGN AND METHODS


The Health Utilities Index Mark 3 (HUI-3) was used to measure heath utility in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial (N = 8713). Five macrovascular complications (myocardial infarction [MI], congestive heart failure [CHF], stroke, angina, and revascularization surgery [RS]) and three microvascular complications (nephropathy [renal failure], retinopathy [severe vision loss], and neuropathy [severe pressure sensation loss]) were included in a set of alternative modelling approaches including the ordinary least squares (OLS) model, fixed effects model, and random effects model to estimate the complication-related health utility decrements.
RESULTS


All macrovascular complications were associated with decrements of HUI-3 scores: MI (event year: - 0.042, successive years: - 0.011), CHF (event year: - 0.089, successive years: - 0.041), stroke (event year: - 0.204, successive years: - 0.101), angina (event year: - 0.010, successive years: - 0.032), and revascularization (event year: - 0.038, successive years: - 0.016) (all p < 0.05). For microvascular complications, severe vision loss (- 0.057), and severe pressure sensation loss (- 0.066) were significantly associated with decrements of HUI-3 scores (both p < 0.05). Hypoglycemia (both severe and symptomatic) was found to be associated with a 0.036 decrement of health utility at event year, and a 0.033 decrement of health utility at successive years. Results from an OLS model are preferred for supporting a microsimulation model while a fixed effects model is preferred to describe direct health impacts from complications.
CONCLUSIONS


Macrovascular and microvascular complications caused QALY decrements in patients with type 2 diabetes. While only part of the total impaired QALY is experienced during the event year, further QALY decrements for successive years were quite substantial.",2019,"Hypoglycemia (both severe and symptomatic) was found to be associated with a 0.036 decrement of health utility at event year, and a 0.033 decrement of health utility at successive years.",['patients with type 2 diabetes'],[],"['Hypoglycemia', 'HUI-3 scores', 'severe pressure sensation loss', 'microvascular complications, severe vision loss', 'CHF', 'All macrovascular complications', 'health utility', 'ordinary least squares (OLS) model, fixed effects model, and random effects model to estimate the complication-related health utility decrements', 'Five macrovascular complications (myocardial infarction [MI], congestive heart failure [CHF], stroke, angina, and revascularization surgery [RS]) and three microvascular complications (nephropathy [renal failure], retinopathy [severe vision loss], and neuropathy [severe pressure sensation loss', 'HUI-3 scores: MI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",[],"[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0234222', 'cui_str': 'Baresthesia'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1301509', 'cui_str': 'Severe visual impairment'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0035309', 'cui_str': 'Retinal disorder'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}]",,0.0222959,"Hypoglycemia (both severe and symptomatic) was found to be associated with a 0.036 decrement of health utility at event year, and a 0.033 decrement of health utility at successive years.","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Shao', 'Affiliation': 'Department of Health Policy and Management, School of Public Health and Tropical Medicine, Tulane University, 1440 Canal Street, Suite 1900, New Orleans, LA, 70112, USA.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Health Policy and Management, School of Public Health and Tropical Medicine, Tulane University, 1440 Canal Street, Suite 1900, New Orleans, LA, 70112, USA.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Fonseca', 'Affiliation': 'School of Medicine, Tulane University, New Orleans, LA, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Stoecker', 'Affiliation': 'Department of Health Policy and Management, School of Public Health and Tropical Medicine, Tulane University, 1440 Canal Street, Suite 1900, New Orleans, LA, 70112, USA.'}, {'ForeName': 'Lizheng', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Health Policy and Management, School of Public Health and Tropical Medicine, Tulane University, 1440 Canal Street, Suite 1900, New Orleans, LA, 70112, USA. lshi1@tulane.edu.'}]",PharmacoEconomics,['10.1007/s40273-019-00775-8']
153,32384676,"A Single-Arm, Prospective, Exploratory Study to Preliminarily Test Effectiveness and Safety of Skin Electrical Stimulation for Leber Hereditary Optic Neuropathy.","Leber hereditary optic neuropathy (LHON) is an intractable disease associated with mitochondrial DNA (mtDNA) mutations. In this preliminary, single-arm, prospective, open-label exploratory trial, we investigated the effectiveness and safety of skin electrical stimulation (SES) for cases of LHON harboring the mtDNA 11,778 mutation. Of the 11 enrolled patients, 10 completed six sessions of SES once every two weeks over a 10-week period. The primary outcome measure was the change in logarithm of the minimum angle of resolution (logMAR)-converted best-corrected visual acuity (BCVA) at one week after the last session of SES. The main secondary outcome measures were the logMAR BCVA at four and eight weeks and Humphrey visual field test sensitivities at one, four, and eight weeks. At all follow-up points, the logMAR BCVA had improved significantly from baseline [1.80 (1.70–1.80) at baseline, 1.75 (1.52–1.80) at one week, 1.75 (1.50–1.80) at four weeks, and 1.75 (1.52–1.80) at eight weeks;  p  < 0.05]. At eight weeks of follow-up, five patients showed >2-fold increase in the summed sensitivity at 52 measurement points from baseline. No adverse effects were observed. In conclusion, SES could be a viable treatment option for patients with LHON in the chronic phase harboring the mtDNA 11,778 mutation.",2020,No adverse effects were observed.,"['11 enrolled patients', 'Leber Hereditary Optic Neuropathy', 'cases of LHON harboring the mtDNA 11,778 mutation', 'patients with LHON in the chronic phase harboring the mtDNA 11,778 mutation']","['SES', 'Skin Electrical Stimulation', 'skin electrical stimulation (SES']","['logMAR BCVA at four and eight weeks and Humphrey visual field test sensitivities', 'summed sensitivity', 'change in logarithm of the minimum angle of resolution (logMAR)-converted best-corrected visual acuity (BCVA', 'logMAR BCVA', 'adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917796', 'cui_str': ""Leber's optic atrophy""}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0430866', 'cui_str': 'Humphrey perimeter plot'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",11.0,0.0623657,No adverse effects were observed.,"[{'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Kurimoto', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Ueda', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.'}, {'ForeName': 'Sotaro', 'Initials': 'S', 'LastName': 'Mori', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.'}, {'ForeName': 'Seiko', 'Initials': 'S', 'LastName': 'Kamada', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Sakamoto', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Yamada-Nakanishi', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Matsumiya', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.'}]",Journal of clinical medicine,['10.3390/jcm9051359']
154,32384874,Serum level of IL-1ra was associated with the treatment of latent tuberculosis infection in a Chinese population.,"BACKGROUND


Dynamically changed levels of serum cytokines might predict the development of active TB from latent tuberculosis infection (LTBI) and monitor preventive treatment effectiveness. The aim of the study was to identify potential serum cytokines associated with LTBI treatment which might predict active disease development in a Chinese population.
METHODS


Based on a randomized controlled trial aiming to explore short-course regimens for LTBI treatment, the dynamic changes of serum cytokines determined by bead-based multiplex assays were investigated for the participants who developed active TB during follow-up and age and gender matched controls stayed healthy.
RESULTS


Totally, 21 patients diagnosed with active tuberculosis (TB) during the 2-year follow-up (12 from treated groups and 9 from untreated controls) and 42 age and gender matched healthy controls (24 from treated groups and 18 from untreated controls) were included in the study. Before treatment, serum IL-1ra was statistically higher among those who developed active disease during follow-up as compared with those stayed healthy. As for treated participants, the levels of IL-1ra were significantly lower after treatment in comparison with those before treatment both in active TB group (p = 0.002) and non-TB group (p = 0.009). For untreated participants, the levels of IL-1ra were not statistically different between different time points both in active TB group (p = 0.078) and non-TB group (p = 0.265).
CONCLUSION


Our results suggested that declined serum level of IL-1ra was associated with LTBI treatment. Further studies are needed to verify whether it could be used to evaluate LTBI treatment and to predict active disease development.",2020,"For untreated participants, the levels of IL-1ra were not statistically different between different time points both in active TB group (p = 0.078) and non-TB group (p = 0.265).
","['participants who developed active TB during follow-up and age and gender matched controls stayed healthy', '21 patients diagnosed with active tuberculosis (TB) during the 2-year follow-up (12 from treated groups and 9 from untreated controls) and 42 age and gender matched healthy controls (24 from treated groups and 18 from untreated controls) were included in the study']",[],"['serum level of IL-1ra', 'levels of IL-1ra', 'Serum level of IL-1ra', 'serum IL-1ra']","[{'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}]",21.0,0.136814,"For untreated participants, the levels of IL-1ra were not statistically different between different time points both in active TB group (p = 0.078) and non-TB group (p = 0.265).
","[{'ForeName': 'Haoran', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 9 Dong Dan San Tiao, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Xuefang', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 9 Dong Dan San Tiao, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Henan', 'Initials': 'H', 'LastName': 'Xin', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 9 Dong Dan San Tiao, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""The Sixth People's Hospital of Zhengzhou, Zhengzhou, 450061, China.""}, {'ForeName': 'Shouguo', 'Initials': 'S', 'LastName': 'Pan', 'Affiliation': 'The Center for Disease Prevention and Control of Zhongmu County, Zhengzhou, 451470, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Guan', 'Affiliation': ""The Sixth People's Hospital of Zhengzhou, Zhengzhou, 450061, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Shen', 'Affiliation': ""The Sixth People's Hospital of Zhengzhou, Zhengzhou, 450061, China.""}, {'ForeName': 'Zisen', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'The Center for Disease Prevention and Control of Zhongmu County, Zhengzhou, 451470, China.'}, {'ForeName': 'Dakuan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'The Center for Disease Prevention and Control of Zhongmu County, Zhengzhou, 451470, China.'}, {'ForeName': 'Xueling', 'Initials': 'X', 'LastName': 'Guan', 'Affiliation': ""The Sixth People's Hospital of Zhengzhou, Zhengzhou, 450061, China.""}, {'ForeName': 'Jiaoxia', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'The Center for Disease Prevention and Control of Zhongmu County, Zhengzhou, 451470, China.'}, {'ForeName': 'Boxuan', 'Initials': 'B', 'LastName': 'Feng', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 9 Dong Dan San Tiao, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Gastroenterology Department, PLA Rocket Force Characteristic Medical Center, Beijing, 100088, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Jin', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 9 Dong Dan San Tiao, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 9 Dong Dan San Tiao, Dongcheng District, Beijing, 100730, China. gaolei@ipbcams.ac.cn.'}]",BMC infectious diseases,['10.1186/s12879-020-05047-x']
155,32390720,Effects of an Impulse Frequency Dependent 10-Week Whole-body Electromyostimulation Training Program on Specific Sport Performance Parameters.,"The difference in the efficacy of altered stimulation parameters in whole-body-electromyostimulation (WB-EMS) training remains largely unexplored. However, higher impulse frequencies (>50 Hz) might be most adequate for strength gain. The aim of this study was to analyze potential differences in sports-related performance parameters after a 10-week WB-EMS training with different frequencies. A total of 51 untrained participants (24.9 ± 3.9 years, 174 ± 9 cm, 72.4 ± 16.4 kg, BMI 23.8 ± 4.1, body fat 24.7 ± 8.1 %) was randomly divided into three groups: one inactive control group (CON) and two training groups. They completed a 10-week WB-EMS program of 1.5 sessions/week, equal content but different stimulation frequencies (training with 20 Hz (T20) vs. training with 85 Hz (T85)). Before and after intervention, all participants completed jumping (Counter Movement Jump (CMJ), Squat Jump (SJ), Drop Jump (DJ)), sprinting (5m, 10m, 30m), and strength tests (isometric trunk flexion/extension). One-way ANOVA was applied to calculate parameter changes. Post-hoc least significant difference tests were performed to identify group differences. Significant differences were identified for CMJ (p = 0.007), SJ (p = 0.022), trunk flexion (p = 0.020) and extension (p=.013) with significant group differences between both training groups and CON (not between the two training groups T20 and T85). A 10-week WB-EMS training leads to significant improvements of jump and strength parameters in untrained participants. No differences could be detected between the frequencies. Therefore, both stimulation frequencies can be regarded as adequate for increasing specific sport performance parameters. Further aspects as regeneration or long term effects by the use of different frequencies still need to be clarified.",2020,"Significant differences were identified for CMJ (p = 0.007), SJ (p = 0.022), trunk flexion (p = 0.020) and extension (p=.013) with significant group differences between both training groups and CON (not between the two training groups T20 and T85).","['51 untrained participants (24.9 ± 3.9 years, 174 ± 9 cm, 72.4 ± 16.4 kg, BMI 23.8 ± 4.1, body fat 24.7 ± 8.1 ', 'untrained participants']","['inactive control group (CON', 'Impulse Frequency Dependent 10-Week Whole-body Electromyostimulation Training Program', 'jumping (Counter Movement Jump (CMJ), Squat Jump (SJ), Drop Jump (DJ']","['trunk flexion', 'Specific Sport Performance Parameters', 'jump and strength parameters']","[{'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C4517875', 'cui_str': '8.1'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}]",51.0,0.012783,"Significant differences were identified for CMJ (p = 0.007), SJ (p = 0.022), trunk flexion (p = 0.020) and extension (p=.013) with significant group differences between both training groups and CON (not between the two training groups T20 and T85).","[{'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Berger', 'Affiliation': 'Department of Sports Science, Technische Universität Kaiserslautern, Kaiserslautern, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Ludwig', 'Affiliation': 'Department of Sports Science, Technische Universität Kaiserslautern, Kaiserslautern, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'Department of Sports Science, Technische Universität Kaiserslautern, Kaiserslautern, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Backfisch', 'Affiliation': 'Department of Sports Science, Technische Universität Kaiserslautern, Kaiserslautern, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Kemmler', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen, Erlangen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fröhlich', 'Affiliation': 'Department of Sports Science, Technische Universität Kaiserslautern, Kaiserslautern, Germany.'}]",Journal of sports science & medicine,[]
156,32390721,Acute Maltodextrin Supplementation During Resistance Exercise.,"Most of the research investigating the ergogenic enhancing mechanisms of carbohydrate have been conducted using aerobic based exercise. Therefore, the purpose of this study was to investigate the effects of pre-exercise maltodextrin ingestion on resistance exercise performance, serum insulin, epinephrine, glucose, and muscle glycogen concentrations. In a double blind, cross over, repeated measures design, participants completed four sets to failure at 70% of 1-RM with 45s rest on the angled leg press with or without pre-exercise maltodextrin (2g/kg) after a 3hr fast. Serum glucose, epinephrine, and insulin were assessed at baseline, 30 min post-ingestion, immediately after, and 1hr post-exercise with or without carbohydrate supplementation. Muscle glycogen was assessed from biopsy specimens sampled from the vastus lateralis before supplementation, immediately after exercise, and 1hr post exercise under both conditions. There was no main effect of supplement on resistance exercise performance (p = 0.18). Muscle glycogen concentration decreased across time for both groups (p < 0.001). There was an interaction in serum glucose decreasing more during exercise in the carbohydrate condition (p = 0.026). An interaction occurred showing insulin decreased during exercise in the carbohydrate condition (p = 0.003). Also, there was a main effect of insulin being elevated with carbohydrate consumption (p = 0.027). Epinephrine was decreased across all time points after carbohydrate ingestion (p = 0.023). Carbohydrate supplementation before resistance exercise did not improve leg press performance to fatigue despite increased metabolic substrate availability. These results indicate that pre-exercise dietary carbohydrate will be utilized preferentially during exercise due to decreased epinephrine, decreased serum glucose, and increased insulin concentrations. However, the increases in glycolytic substrate availability will not increase exercise performance or glycogen content following 1hr of recovery.",2020,There was an interaction in serum glucose decreasing more during exercise in the carbohydrate condition (p = 0.026).,[],"['Epinephrine', 'Carbohydrate supplementation before resistance exercise', '1-RM with 45s rest on the angled leg press with or without pre-exercise maltodextrin', 'pre-exercise maltodextrin ingestion', 'Acute Maltodextrin Supplementation']","['resistance exercise performance', 'Muscle glycogen', 'serum glucose', 'resistance exercise performance, serum insulin, epinephrine, glucose, and muscle glycogen concentrations', 'exercise performance or glycogen content', 'serum glucose, and increased insulin concentrations', 'Muscle glycogen concentration', 'Serum glucose, epinephrine, and insulin']",[],"[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0556103', 'cui_str': 'Carbohydrate supplementation'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",,0.109494,There was an interaction in serum glucose decreasing more during exercise in the carbohydrate condition (p = 0.026).,"[{'ForeName': 'Dylan T', 'Initials': 'DT', 'LastName': 'Wilburn', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Baylor University, Waco, TX USA.'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Machek', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Baylor University, Waco, TX USA.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Cardaci', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Baylor University, Waco, TX USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Hwang', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Baylor University, Waco, TX USA.'}, {'ForeName': 'Darryn S', 'Initials': 'DS', 'LastName': 'Willoughby', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Baylor University, Waco, TX USA.'}]",Journal of sports science & medicine,[]
157,32390724,One Session of Extracorporeal Shockwave Therapy-Induced Modulation on Tendon Shear Modulus is Associated with Reduction in Pain.,"The aim of the study was to examine the immediate effect of 1 session of extracorporeal shockwave therapy (ESWT) on patellar tendon stiffness and to explore the relationship between the change in tendon stiffness and the pain intensity. Thirty-four male athletes aged 22.2 ± 3.8 with patellar tendinopathy were recruited. The participants were randomized into ESWT and sham groups. The ESWT group received 1500 impulses of ESWT at 4 Hz with maximal tolerable pain intensity and the sham group received intensities below 0.08 mJ/mm 2 . Supersonic Shearwave Imaging (SSI) was used to measure tendon shear modulus (an index of tissue stiffness), and a visual analogue scale was used to quantify the pain intensity during compression with 10 lb (4.535 kg) pressure directed on the most tender part and then during a single-leg declined-squat test. A significant reduction in tendon shear modulus (from 57.4 ± 25.5 kPa to 40.6 ± 17.6kPa, p = 0.001) was detected in the ESWT receiving ESWT with an intensity from 0.13-0.33 mJ/mm 2  but not the sham group (from 47.7 ± 17.1 kPa to 41.0 ± 12.7 kPa; p = 0.06). In the ESWT group, the change in tendon shear modulus was associated with the change in the intensity of pain during single-legged declined-squat test (ρ = 0.55; p = 0.023) but not pressure pain (p > 0.05). These findings suggest that one session of ESWT induces reduction of tendon stiffness in volleyball and basketball players with patellar tendinopathy. The reduction in tendon stiffness is associated with reduction in pain during single-legged declined-squat test.",2020,"A significant reduction in tendon shear modulus (from 57.4 ± 25.5 kPa to 40.6 ± 17.6kPa, p = 0.001) was detected in the ESWT receiving ESWT with an intensity from 0.13-0.33 mJ/mm 2  but not the sham group (from 47.7 ± 17.1 kPa to 41.0 ± 12.7 kPa; p = 0.06).","['Thirty-four male athletes aged 22.2 ± 3.8 with patellar tendinopathy were recruited', 'volleyball and basketball players with patellar tendinopathy']","['ESWT', 'extracorporeal shockwave therapy (ESWT', 'Extracorporeal Shockwave Therapy-Induced Modulation', 'Supersonic Shearwave Imaging (SSI']","['pressure pain', 'patellar tendon stiffness', 'tendon shear modulus', 'change in tendon shear modulus', 'intensity of pain', 'pain', 'tendon stiffness', 'tendon stiffness and the pain intensity']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",34.0,0.0444846,"A significant reduction in tendon shear modulus (from 57.4 ± 25.5 kPa to 40.6 ± 17.6kPa, p = 0.001) was detected in the ESWT receiving ESWT with an intensity from 0.13-0.33 mJ/mm 2  but not the sham group (from 47.7 ± 17.1 kPa to 41.0 ± 12.7 kPa; p = 0.06).","[{'ForeName': 'Zhi Jie', 'Initials': 'ZJ', 'LastName': 'Zhang', 'Affiliation': 'Luoyang Orthopedic Hospital of Henan Province, Orthopedic Hospital of Henan Province, Luoyang, China.'}, {'ForeName': 'Wai Chun', 'Initials': 'WC', 'LastName': 'Lee', 'Affiliation': 'Luoyang Orthopedic Hospital of Henan Province, Orthopedic Hospital of Henan Province, Luoyang, China.'}, {'ForeName': 'Siu Ngor', 'Initials': 'SN', 'LastName': 'Fu', 'Affiliation': 'Department of Rehabilitation Sciences, the Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}]",Journal of sports science & medicine,[]
158,32390725,Impact of Duration of Eccentric Movement in the One-Repetition Maximum Test Result in the Bench Press among Women.,"Scientific studies related to resistance training have considered many variables; however, the tempo of movement of particular repetitions is often neglected or not reported in resistance training practice and research. The aim of the study was to determine the effect of different duration of the eccentric (ECC) phase of movement on one-repetition maximum test (1RM) results during the bench press exercise (BP). Twenty-one strength trained females (age = 23.4 ± 2.2 years, body mass = 52.3 ± 6.7 kg), with a minimum one year of strength training experience took part in the study. The experiment was conducted following a randomized crossover design, where each participant completed the 1RM test in the BP with three different duration times of the ECC movement: 2/0/X, 4/0/X, 6/0/X. Concentric (CON) movement was performed with maximal velocity (X). The ANOVA with repeated measures were used to compare the differences between the analyzed variables. The results of the study indicated the maximal load in the 1RM test was significantly higher during the BP with the 2/0/X tempo compared to 6/0/X (p < 0.01) and 4/0/X tempos (p < 0.01). Therefore, the results indicated that the longer the duration of the ECC phase of movement, the greater the decrease in the result of the 1RM test. The 1RM test procedure should include information about the movement tempo used during the test protocol.",2020,The results of the study indicated the maximal load in the 1RM test was significantly higher during the BP with the 2/0/X tempo compared to 6/0/X (p < 0.01) and 4/0/X tempos (p < 0.01).,"['Women', 'Twenty-one strength trained females (age = 23.4 ± 2.2 years, body mass = 52.3 ± 6.7 kg), with a minimum one year of strength training experience took part in the study']",[],['maximal load in the 1RM test'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",21.0,0.0242881,The results of the study indicated the maximal load in the 1RM test was significantly higher during the BP with the 2/0/X tempo compared to 6/0/X (p < 0.01) and 4/0/X tempos (p < 0.01).,"[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Wilk', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}, {'ForeName': 'Mariola', 'Initials': 'M', 'LastName': 'Gepfert', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Krzysztofik', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Mostowik', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Filip', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Hajduk', 'Affiliation': 'Galen-Orthopaedics, 43-150 Bierun, ul Jerzego 6, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Zajac', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}]",Journal of sports science & medicine,[]
159,32379763,Cost-Effectiveness of ramucirumab plus paclitaxel as a second-line therapy for advanced gastric or gastro-oesophageal cancer in China.,"AIM


That clinical trial (RAINBOW) showed that a 7.4 months overall survival benefit with the combination therapy with ramucirumab (RAM) and paclitaxel (PAC) as second-line therapy for patients with recurrent or metastatic gastric or gastro-oesophageal junction adenocarcinoma, compared with placebo (PLA) plus paclitaxel. We performed an analysis to assess the cost-effectiveness of RAM from a Chinese perspective and recognized the range of drug costs.
METHODS


By building a Markov model to estimate quality-adjusted life-years (QALYs), life-years (LYs) and lifetime costs. Transition probabilities, costs and utilities were estimated for the published literature, Chinese health care system and local price setting. We performed threshold analyses and probabilistic sensitivity analyses to evaluate the uncertainty of the model.
RESULTS


Compared with PLA strategy, RAM strategy provided an incremental survival benefit of 1.22 LYs and 0.64 QALYs. The probabilistic sensitivity analysis showed that when RAM costs less than $151 or $753 per 4 weeks, the incremental cost-effectiveness ratio (ICER) approximated the willingness-to-pay threshold (WTP), suggesting that there was 50% likelihood that the ICER for RAM + PAC would be less than $44528.4 per QALY or $48121 per QALY, respectively.
CONCLUSIONS


For patients with advanced gastric or gastro-oesophageal junction adenocarcinoma who fail first-line chemotherapy, our results are conducive to the multilateral drug price guidance negotiations of RAM in China.",2020,"Compared with PLA strategy, RAM strategy provided an incremental survival benefit of 1.22 LYs and 0.64 QALYs.","['advanced gastric or gastro-oesophageal cancer in China', 'patients with advanced gastric or gastro-oesophageal junction adenocarcinoma who fail first-line chemotherapy', 'patients with recurrent or metastatic gastric or gastro-oesophageal junction adenocarcinoma']","['ramucirumab plus paclitaxel', 'placebo (PLA) plus paclitaxel', 'ramucirumab (RAM) and paclitaxel (PAC']","['Transition probabilities, costs and utilities', 'quality-adjusted life-years (QALYs), life-years (LYs) and lifetime costs', 'incremental survival benefit', 'overall survival benefit', 'incremental cost-effectiveness ratio (ICER']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0546837', 'cui_str': 'Malignant tumor of esophagus'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}]","[{'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0632798,"Compared with PLA strategy, RAM strategy provided an incremental survival benefit of 1.22 LYs and 0.64 QALYs.","[{'ForeName': 'Sini', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'The Xiangya Nursing School, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Liubao', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Chongqing', 'Initials': 'C', 'LastName': 'Tan', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'The Second Xiangya Hospital, PET-CT Center, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'The Xiangya Nursing School, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Lidan', 'Initials': 'L', 'LastName': 'Yi', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jianhe', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}]",PloS one,['10.1371/journal.pone.0232240']
160,32379766,Nocebo hyperalgesia can be induced by classical conditioning without involvement of expectancy.,"Influential theoretical accounts take the position that classical conditioning can induce placebo effects through conscious expectancies. In the current study two different conditioning procedures (hidden and open) were used to separate expectancy from conditioning in order to reveal the role of expectancy in the formation of nocebo hyperalgesia. Eighty-seven healthy females were randomly assigned to three groups (hidden conditioning, open conditioning, and control). Participants were selected according to the Fear of Pain Questionnaire scores and assigned to two subgroups: high and low level of fear of pain (trait). They received electrocutaneous pain stimuli preceded by either an orange or blue color. During the conditioning phase, one color was paired with pain stimuli of moderate intensity (control stimuli) and the other color was paired with pain stimuli of high intensity (nocebo stimuli) in both hidden and open conditioning groups. Only participants in the open conditioning group were informed about this association, however just before the testing phase the expectancy of hyperalgesia induced in this way was withdrawn. In the control group, both colors were followed by control pain stimuli. During the testing phase all participants received a series of stimuli of the same intensity, regardless of the preceding color. Participants rated pain intensity, expectancy of pain intensity and fear (state). We found that nocebo hyperalgesia was induced by hidden rather than open conditioning. The hidden conditioning procedure did not produce conscious expectancies related to pain. Nocebo hyperalgesia was induced in participants with low and high fear of pain and there was no difference in the magnitude of the nocebo effect between both groups. Nocebo hyperalgesia was not predicted by the fear of upcoming painful stimuli.",2020,Nocebo hyperalgesia was induced in participants with low and high fear of pain and there was no difference in the magnitude of the nocebo effect between both groups.,['Eighty-seven healthy females'],['electrocutaneous pain stimuli preceded by either an orange or blue color'],"['Fear of Pain Questionnaire scores', 'pain intensity, expectancy of pain intensity and fear (state', 'nocebo hyperalgesia', 'Nocebo hyperalgesia', 'low level of fear of pain (trait']","[{'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0440277', 'cui_str': 'Orange - fruit'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}]","[{'cui': 'C0233702', 'cui_str': 'Algophobia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1319227', 'cui_str': 'Level of fear'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",87.0,0.0171263,Nocebo hyperalgesia was induced in participants with low and high fear of pain and there was no difference in the magnitude of the nocebo effect between both groups.,"[{'ForeName': 'Elżbieta A', 'Initials': 'EA', 'LastName': 'Bajcar', 'Affiliation': 'Pain Research Group, Institute of Psychology, Jagiellonian University, Kraków, Poland.'}, {'ForeName': 'Wacław M', 'Initials': 'WM', 'LastName': 'Adamczyk', 'Affiliation': 'Pain Research Group, Institute of Psychology, Jagiellonian University, Kraków, Poland.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Wiercioch-Kuzianik', 'Affiliation': 'Pain Research Group, Institute of Psychology, Jagiellonian University, Kraków, Poland.'}, {'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Bąbel', 'Affiliation': 'Pain Research Group, Institute of Psychology, Jagiellonian University, Kraków, Poland.'}]",PloS one,['10.1371/journal.pone.0232108']
161,32379777,Transplacental transfer of glyburide in women with gestational diabetes and neonatal hypoglycemia risk.,"BACKGROUND


In pregnant women with gestational diabetes, glyburide can be an alternative to insulin despite concerns about its transplacental transfer. However, transplacental transfer of glyburide is poorly quantified and the relationship between cord blood glyburide concentration and hypoglycemia has not been studied. Our objective was to quantify the transplacental transfer of glyburide at delivery and to study the association between the cord blood glyburide concentration and the risk of neonatal hypoglycemia in patients with gestational diabetes treated with glyburide.
METHODS AND FINDINGS


INDAO was a multicenter, noninferiority, randomized trial conducted between May 2012 and November 2016 in 914 women with singleton pregnancies and gestational diabetes. An ancillary study was conducted in the 87 patients of the Bicêtre University Hospital Center. The sample consisted of 46 patients with utilizable assays at delivery. The relationships between glyburide concentration and the time since the last intake of glyburide and between fetal glyburide concentration and neonatal hypoglycemia were modeled with linear or logistic regressions using fractional polynomials. There was placental transfer of glyburide at a fetal to maternal ratio of 62% (95% CI [50; 74]). Umbilical cord blood glyburide concentration decreased steeply after the last maternal glyburide intake. After 24 hours, the mean umbilical cord blood concentration was less than 5 ng/mL. Neonatal hypoglycemia risk was increased with an odds ratio of hypoglycemia equal to 3.70 [1.40-9.77] for each 10 ng/mL increase in the cord blood glyburide concentration. However, no newborns were admitted to the NICU because of clinical signs of hypoglycemia or for treatment of hypoglycemia.
CONCLUSION


Considering that neonatal glyburide exposure may be limited by stopping treatment a sufficient time before labor, there may still be a place for glyburide in the management of gestational diabetes.",2020,"After 24 hours, the mean umbilical cord blood concentration was less than 5 ng/mL. Neonatal hypoglycemia risk was increased with an odds ratio of hypoglycemia equal to 3.70 [1.40-9.77] for each 10 ng/mL increase in the cord blood glyburide concentration.","['46 patients with utilizable assays at delivery', 'May 2012 and November 2016 in 914 women with singleton pregnancies and gestational diabetes', '87 patients of the Bicêtre University Hospital Center', 'pregnant women with gestational diabetes', 'patients with gestational diabetes treated with glyburide', 'women with gestational diabetes and neonatal hypoglycemia risk']",['glyburide'],"['fetal glyburide concentration and neonatal hypoglycemia', 'neonatal hypoglycemia', 'Umbilical cord blood glyburide concentration', 'mean umbilical cord blood concentration', 'Neonatal hypoglycemia risk', 'Transplacental transfer', 'placental transfer of glyburide', 'cord blood glyburide concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0158986', 'cui_str': 'Neonatal hypoglycemia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0017628', 'cui_str': 'Glyburide'}]","[{'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0158986', 'cui_str': 'Neonatal hypoglycemia'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0442375', 'cui_str': 'Transplacental approach'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}]",914.0,0.0735579,"After 24 hours, the mean umbilical cord blood concentration was less than 5 ng/mL. Neonatal hypoglycemia risk was increased with an odds ratio of hypoglycemia equal to 3.70 [1.40-9.77] for each 10 ng/mL increase in the cord blood glyburide concentration.","[{'ForeName': 'Hanane', 'Initials': 'H', 'LastName': 'Bouchghoul', 'Affiliation': 'Department of Gynecology-Obstetrics, Assistance Publique-Hôpitaux de Paris, Bicêtre Hospital, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Alvarez', 'Affiliation': 'Département de Pharmacologie-Toxicologie, Assistance Publique-Hôpitaux de Paris, Hôpital Raymond Poincaré, MasSpecLab, Plateforme de spectrométrie de masse, Inserm U-1173, UFR PIFO, Université Versailles Saint Quentin-en-Yvelines, Garches, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Verstuyft', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, Service de Génétique moléculaire, Pharmacogénétique et Hormonologie, Inserm U 1178 équipe Dépression, CESP, Université Paris-Sud, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bouyer', 'Affiliation': 'Université Paris-Saclay, UVSQ, Inserm, CESP, Villejuif, France.'}, {'ForeName': 'Marie-Victoire', 'Initials': 'MV', 'LastName': 'Senat', 'Affiliation': 'Department of Gynecology-Obstetrics, Assistance Publique-Hôpitaux de Paris, Bicêtre Hospital, Le Kremlin-Bicêtre, France.'}]",PloS one,['10.1371/journal.pone.0232002']
162,32384122,Improved residual fat malabsorption and growth in children with cystic fibrosis treated with a novel oral structured lipid supplement: A randomized controlled trial.,"BACKGROUND


In the primary analysis of a 12-month double-blind randomized active placebo-controlled trial, treatment of children with cystic fibrosis (CF) and pancreatic insufficiency (PI) with a readily absorbable structured lipid (Encala™, Envara Health, Wayne, PA) was safe, well-tolerated and improved dietary fat absorption (stool coefficient of fat absorption [CFA]), growth, and plasma fatty acids (FA).
OBJECTIVE


To determine if the Encala™ treatment effect varied by severity of baseline fat malabsorption.
METHODS


Subjects (n = 66, 10.5±3.0 yrs, 39% female) with baseline CFA who completed a three-month treatment with Encala™ or a calorie and macronutrient-matched placebo were included in this subgroup analysis. Subjects were categorized by median baseline CFA: low CFA (<88%) and high CFA (≥88%). At baseline and 3-month evaluations, CFA (72-hour stool, weighed food record) and height (HAZ), weight (WAZ) and BMI (BMIZ) Z-scores were calculated. Fasting plasma fatty acid (FA) concentrations were also measured.
RESULTS


Subjects in the low CFA subgroup had significantly improved CFA (+7.5±7.2%, mean 86.3±6.7, p = 0.002), and reduced stool fat loss (-5.7±7.2 g/24 hours) following three months of EncalaTM treatment. These subjects also had increased plasma linoleic acid (+20%), α-linolenic acid (+56%), and total FA (+20%) (p≤0.005 for all) concentrations and improvements in HAZ (0.06±0.08), WAZ (0.17±0.16), and BMIZ (0.20±0.25) (p≤0.002 for all). CFA and FA were unchanged with placebo in the low CFA group, with some WAZ increases (0.14±0.24, p = 0.02). High CFA subjects (both placebo and Encala™ groups) had improvements in WAZ and some FA.
CONCLUSIONS


Subjects with CF, PI and more severe fat malabsorption experienced greater improvements in CFA, FA and growth after three months of Encala™ treatment. Encala™ was safe, well-tolerated and efficacious in patients with CF and PI with residual fat malabsorption and improved dietary energy absorption, weight gain and FA status in this at-risk group.",2020,"Encala™ was safe, well-tolerated and efficacious in patients with CF and PI with residual fat malabsorption and improved dietary energy absorption, weight gain and FA status in this at-risk group.","['children with cystic fibrosis', 'children with cystic fibrosis (CF) and pancreatic insufficiency (PI', 'Subjects (n = 66, 10.5±3.0 yrs, 39% female) with baseline CFA who completed a three-month treatment with Encala™ or a']","['calorie and macronutrient-matched placebo', 'WAZ', 'placebo']","['residual fat malabsorption and growth', 'plasma linoleic acid', 'safe, well-tolerated and efficacious', 'Fasting plasma fatty acid (FA) concentrations', 'CFA', 'total FA', 'CFA and FA', 'CFA (72-hour stool, weighed food record) and height (HAZ), weight (WAZ) and BMI (BMIZ) Z-scores', 'concentrations and improvements in HAZ', 'dietary energy absorption, weight gain and FA status', 'stool fat loss', 'dietary fat absorption (stool coefficient of fat absorption [CFA]), growth, and plasma fatty acids (FA', 'CFA, FA and growth', 'α-linolenic acid']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0030293', 'cui_str': 'Pancreatic insufficiency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0554103', 'cui_str': 'Intestinal malabsorption of fat'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023749', 'cui_str': 'Linoleic acid'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0012171', 'cui_str': 'Dietary fat'}, {'cui': 'C0443214', 'cui_str': 'Fat absorption'}, {'cui': 'C0051405', 'cui_str': 'alpha-Linolenic Acid'}]",,0.119462,"Encala™ was safe, well-tolerated and efficacious in patients with CF and PI with residual fat malabsorption and improved dietary energy absorption, weight gain and FA status in this at-risk group.","[{'ForeName': 'Virginia A', 'Initials': 'VA', 'LastName': 'Stallings', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.""}, {'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Tindall', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.""}, {'ForeName': 'Maria R', 'Initials': 'MR', 'LastName': 'Mascarenhas', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.""}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Maqbool', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.""}, {'ForeName': 'Joan I', 'Initials': 'JI', 'LastName': 'Schall', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.""}]",PloS one,['10.1371/journal.pone.0232685']
163,32385134,Levetiracetam Versus Phenobarbital for Neonatal Seizures: A Randomized Controlled Trial.,"BACKGROUND AND OBJECTIVES


There are no US Food and Drug Administration-approved therapies for neonatal seizures. Phenobarbital and phenytoin frequently fail to control seizures. There are concerns about the safety of seizure medications in the developing brain. Levetiracetam has proven efficacy and an excellent safety profile in older patients; therefore, there is great interest in its use in neonates. However, randomized studies have not been performed. Our objectives were to study the efficacy and safety of levetiracetam compared with phenobarbital as a first-line treatment of neonatal seizures.
METHODS


The study was a multicenter, randomized, blinded, controlled, phase IIb trial investigating the efficacy and safety of levetiracetam compared with phenobarbital as a first-line treatment for neonatal seizures of any cause. The primary outcome measure was complete seizure freedom for 24 hours, assessed by independent review of the EEGs by 2 neurophysiologists.
RESULTS


Eighty percent of patients (24 of 30) randomly assigned to phenobarbital remained seizure free for 24 hours, compared with 28% of patients (15 of 53) randomly assigned to levetiracetam ( P  < .001; relative risk 0.35 [95% confidence interval: 0.22-0.56]; modified intention-to-treat population). A 7.5% improvement in efficacy was achieved with a dose escalation of levetiracetam from 40 to 60 mg/kg. More adverse effects were seen in subjects randomly assigned to phenobarbital (not statistically significant).
CONCLUSIONS


In this phase IIb study, phenobarbital was more effective than levetiracetam for the treatment of neonatal seizures. Higher rates of adverse effects were seen with phenobarbital treatment. Higher-dose studies of levetiracetam are warranted, and definitive studies with long-term outcome measures are needed.",2020,"More adverse effects were seen in subjects randomly assigned to phenobarbital (not statistically significant).
","['Neonatal Seizures', 'neonatal seizures of any cause', 'older patients']","['levetiracetam', 'phenobarbital', 'Phenobarbital and phenytoin', 'Levetiracetam', 'Levetiracetam Versus Phenobarbital']","['complete seizure freedom for 24 hours, assessed by independent review of the EEGs by 2 neurophysiologists', 'phenobarbital remained seizure free', 'efficacy and safety', 'efficacy', 'adverse effects']","[{'cui': 'C0159020', 'cui_str': 'Convulsions in the newborn'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C0031507', 'cui_str': 'Phenytoin'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0699752', 'cui_str': 'Review of'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.327532,"More adverse effects were seen in subjects randomly assigned to phenobarbital (not statistically significant).
","[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Sharpe', 'Affiliation': ""Department of Paediatric Neurology, Starship Children's Health, Auckland, New Zealand.""}, {'ForeName': 'Gail E', 'Initials': 'GE', 'LastName': 'Reiner', 'Affiliation': ""Department of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California.""}, {'ForeName': 'Suzanne L', 'Initials': 'SL', 'LastName': 'Davis', 'Affiliation': ""Department of Paediatric Neurology, Starship Children's Health, Auckland, New Zealand.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nespeca', 'Affiliation': ""Department of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California.""}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Gold', 'Affiliation': ""Department of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California.""}, {'ForeName': 'Maynard', 'Initials': 'M', 'LastName': 'Rasmussen', 'Affiliation': 'San Diego Neonatology Inc and.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kuperman', 'Affiliation': ""Pediatric Neurology, University of California, San Francisco Benioff Children's Hospital Oakland, Oakland, California.""}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Harbert', 'Affiliation': 'Department of Neurosciences, School of Medicine, University of California, San Diego and Sharp Mary Birch Hospital for Women & Newborns, San Diego, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Michelson', 'Affiliation': ""Division of Pediatric Neurology, Department of Pediatrics, Loma Linda University Children's Hospital, Loma Linda, California.""}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Joe', 'Affiliation': 'Division of Neonatology, Departments of Pediatrics and.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California.""}, {'ForeName': 'Neggy', 'Initials': 'N', 'LastName': 'Rismanchi', 'Affiliation': ""Department of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California.""}, {'ForeName': 'Ngoc Minh', 'Initials': 'NM', 'LastName': 'Le', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Mower', 'Affiliation': ""Department of Neurology, Children's Hospital of Orange County, Orange, California.""}, {'ForeName': 'Jae', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Division of NeoNatology, Departments of Pediatrics and.'}, {'ForeName': 'Malcolm R', 'Initials': 'MR', 'LastName': 'Battin', 'Affiliation': 'Department of Neonatology, Auckland District Health Board, Auckland, New Zealand; and.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lane', 'Affiliation': ""Division of Neonatology, Departments of Pediatrics, University of California, San Diego and Rady Children's Hospital San Diego, San Diego, California.""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Honold', 'Affiliation': ""Division of Neonatology, Departments of Pediatrics, University of California, San Diego and Rady Children's Hospital San Diego, San Diego, California.""}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Knodel', 'Affiliation': ""Division of Neonatology, Departments of Pediatrics, University of California, San Diego and Rady Children's Hospital San Diego, San Diego, California.""}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Arnell', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Bridge', 'Affiliation': 'Division of NeoNatology, Departments of Pediatrics and.'}, {'ForeName': 'Lilly', 'Initials': 'L', 'LastName': 'Lee', 'Affiliation': 'Neurosciences, School of Medicine, University of California, San Diego, San Diego, California.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Ernstrom', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, Keck School of Medicine, University of Southern California, Los Angeles, California.""}, {'ForeName': 'Rema', 'Initials': 'R', 'LastName': 'Raman', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, Keck School of Medicine, University of Southern California, Los Angeles, California.""}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Haas', 'Affiliation': ""Department of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California; rhaas@health.ucsd.edu.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatrics,['10.1542/peds.2019-3182']
164,32390706,Retrograde inspection  vs  standard forward view for the detection of colorectal adenomas during colonoscopy: A back-to-back randomized clinical trial.,"BACKGROUND


The adenoma detection rate (ADR) is inversely associated with the incidence of interval colorectal cancer and serves as a benchmark quality criterion during screening colonoscopy. However, adenoma miss rates reach up to 26% and studies have shown that a second inspection of the right colon in retroflected view (RFV) can increase ADR.
AIM


To assess whether inspection of the whole colon in RFV compared to standard forward view (SFV) can increase ADR.
METHODS


Patients presenting for screening or surveillance colonoscopy were invited to participate in this randomized controlled trial and randomized into two arms. In RFV arm colonoscopy was initially performed with SFV, followed by a second inspection of the whole colon in RFV. In the SFV arm first withdrawal was performed with SFV, followed by a second inspection of the whole colon again with SFV. Number, size and morphology of polyps found during first and second inspection in each colonic segment were recorded and all polyps were removed and sent for histopathology in separate containers.
RESULTS


Two hundred and five patients were randomly assigned to the RFV ( n  = 101) and SFV ( n  = 104) arm. In the RFV arm, both polyp detection rate (PDR) and ADR were increased under second inspection in RFV (PDR 1 st  SFV: 39.8%, PDR 2 nd  RFV: 46.6%; ADR 1 st  SFV: 35.2%, ADR 2 nd  RFV: 42%). Likewise, in the SFV arm, PDR and ADR were increased under second inspection (PDR 1 st  SFV: 37.5%, PDR 2 nd  SFV: 46.6%; ADR 1 st  SFV: 34.1%, ADR 2 nd  SFV: 44.3%) with no significant differences in ADR and PDR between the SFV and RFV arm. Mean number of adenomas per patient (APP) was increased in the RFV and SFV (APP RFV arm: 1 st  SFV: 1.71; 2 nd  RFV: 2.38; APP SFV arm: 1 st  SFV: 1.83, 2 nd  SFV:2.2). The majority of adenomas additionally found during second inspection in RFV or in SFV were located in the transverse and left-sided colon and were > 5 mm in size.
CONCLUSION


Second inspection of the whole colon leads to increased adenoma detection with no differences between SFV and RFV. Hence, increased detection is most likely a feature of the second inspection itself but not of the inspection mode.",2020,"Mean number of adenomas per patient (APP) was increased in the RFV and SFV (APP RFV arm: 1 st  SFV: 1.71; 2 nd  RFV: 2.38; APP SFV arm: 1 st  SFV: 1.83, 2 nd  SFV:2.2).","['Two hundred and five patients', 'Patients presenting for screening or surveillance colonoscopy']","['standard forward view (SFV', 'RFV', 'SFV', 'Retrograde inspection  vs  standard forward view']","['polyp detection rate (PDR) and ADR', 'Mean number of adenomas per patient (APP', 'ADR and PDR', 'PDR and ADR', 'adenoma detection', 'Number, size and morphology of polyps']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}]","[{'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C1845050', 'cui_str': 'Pigmentary Disorder, Reticulate, with Systemic Manifestations'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}]",205.0,0.041914,"Mean number of adenomas per patient (APP) was increased in the RFV and SFV (APP RFV arm: 1 st  SFV: 1.71; 2 nd  RFV: 2.38; APP SFV arm: 1 st  SFV: 1.83, 2 nd  SFV:2.2).","[{'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Rath', 'Affiliation': 'Department of Internal Medicine 1, Division of Gastroenterology, Ludwig Demling Endoscopy Center of Excellence, Friedrich-Alexander-University, Erlangen Nuernberg, Erlangen 91054, Germany. timo.rath@uk-erlangen.de.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Pfeifer', 'Affiliation': 'Department of Internal Medicine 1, Division of Gastroenterology, Ludwig Demling Endoscopy Center of Excellence, Friedrich-Alexander-University, Erlangen Nuernberg, Erlangen 91054, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Neufert', 'Affiliation': 'Department of Internal Medicine 1, Division of Gastroenterology, Ludwig Demling Endoscopy Center of Excellence, Friedrich-Alexander-University, Erlangen Nuernberg, Erlangen 91054, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kremer', 'Affiliation': 'Department of Internal Medicine 1, Division of Gastroenterology, Ludwig Demling Endoscopy Center of Excellence, Friedrich-Alexander-University, Erlangen Nuernberg, Erlangen 91054, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Leppkes', 'Affiliation': 'Department of Internal Medicine 1, Division of Gastroenterology, Ludwig Demling Endoscopy Center of Excellence, Friedrich-Alexander-University, Erlangen Nuernberg, Erlangen 91054, Germany.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Hoffman', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, Klinikum Aschaffenburg, Aschaffenburg 63739, Germany.'}, {'ForeName': 'Markus F', 'Initials': 'MF', 'LastName': 'Neurath', 'Affiliation': 'Department of Internal Medicine 1, Division of Gastroenterology, Ludwig Demling Endoscopy Center of Excellence, Friedrich-Alexander-University, Erlangen Nuernberg, Erlangen 91054, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Zopf', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, Klinikum Fürth, Fürth 90766, Germany.'}]",World journal of gastroenterology,['10.3748/wjg.v26.i16.1962']
165,32391862,A Multifaceted Antimicrobial Stewardship Program for the Treatment of Uncomplicated Cystitis in Nursing Home Residents.,"Importance


Urinary tract infections are the most common infections in nursing home residents. However, most antibiotic use is for unlikely cystitis (ie, nonspecific symptoms and positive culture results secondary to asymptomatic bacteriuria or a urine sample improperly collected for culture) that is unnecessary and inappropriate. This antibiotic use is associated with an increased risk of antimicrobial resistance, adverse drug events, and Clostridioides difficile (formerly Clostridium difficile) infections.
Objective


To determine the association of a multifaceted antimicrobial stewardship and quality improvement intervention with the reduction in unnecessary antimicrobial use for unlikely cystitis among noncatheterized nursing home residents.
Design, Setting, and Participants


A quality improvement intervention evaluation was conducted to target antimicrobial use among residents with unlikely cystitis in 25 nursing homes across the United States. Baseline data were collected between February 1, 2017, and April 30, 2017. The intervention was conducted from May 1, 2017, to April 30, 2018.
Interventions


Intervention nursing homes (n = 12) were randomized to receive a 1-hour introductory webinar, pocket-sized educational cards, tools for system change, and educational clinical vignettes addressing the diagnosis and treatment of suspected uncomplicated cystitis. Monthly web-based coaching calls were held for staff of intervention nursing homes. All facilities received quarterly feedback reports regarding the management of uncomplicated cystitis. Control group nursing homes (n = 13) received usual care.
Main Outcomes and Measures


The primary outcome was the incidence of antibiotic treatment for unlikely cystitis cases, defined using published criteria. Secondary outcomes included overall antibiotic use for any urinary tract infection and the safety outcomes of C difficile infections, as well as all-cause hospitalizations and death.
Results


Among the 25 nursing homes participating in this quality improvement study, including 512 408 intervention facility resident-days and 443 912 control facility resident-days, fewer unlikely cystitis cases were treated with antibiotics in intervention facilities compared with control facilities (adjusted incident rate ratio [AIRR], 0.73 [95% CI, 0.59-0.91]); C difficile infection rates were also lower in intervention nursing homes vs control nursing homes (AIRR, 0.35 [95% CI, 0.19-0.64]). Overall antibiotic use for any type of urinary tract infection was 17% lower in the intervention facilities than the control facilities (AIRR, 0.83 [95% CI, 0.70-0.99]; P = .04). There was no increase in all-cause hospitalizations or deaths due to the intervention (all-cause hospitalizations: AIRR, 0.95 [95% CI, 0.75-1.19]; all-cause death: AIRR, 0.92 [95% CI, 0.73-1.16]).
Conclusions and Relevance


This study suggests that a low-intensity, multifaceted intervention was associated with improved antibiotic prescribing for uncomplicated cystitis in a cohort of nursing homes without an adverse association with other safety outcomes. Although promising, further study is needed to determine whether the intervention could be widely implemented to assist facilities in meeting new federal nursing home requirements for antimicrobial stewardship and quality assurance performance improvement programs.",2020,"Overall antibiotic use for any type of urinary tract infection was 17% lower in the intervention facilities than the control facilities (AIRR, 0.83","['25 nursing homes participating', 'noncatheterized nursing home residents', 'residents with unlikely cystitis in 25 nursing homes across the United States', 'Interventions\n\n\nIntervention nursing homes (n\u2009=\u200912', 'nursing home residents', 'Uncomplicated Cystitis in Nursing Home Residents']","['Multifaceted Antimicrobial Stewardship Program', '1-hour introductory webinar, pocket-sized educational cards, tools for system change, and educational clinical vignettes addressing the diagnosis and treatment of suspected uncomplicated cystitis', 'usual care']","['Overall antibiotic use', 'incidence of antibiotic treatment for unlikely cystitis cases', 'overall antibiotic use for any urinary tract infection and the safety outcomes of C difficile infections, as well as all-cause hospitalizations and death', 'urinary tract infection', 'C difficile infection rates']","[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}]","[{'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0698375,"Overall antibiotic use for any type of urinary tract infection was 17% lower in the intervention facilities than the control facilities (AIRR, 0.83","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Nace', 'Affiliation': 'Division of Geriatric Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Joseph T', 'Initials': 'JT', 'LastName': 'Hanlon', 'Affiliation': 'Division of Geriatric Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Crnich', 'Affiliation': 'Division of Infectious Diseases, University of Wisconsin School of Medicine and Public Health, Madison.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Drinka', 'Affiliation': 'Division of Internal Medicine and Geriatrics, University of Wisconsin, Madison.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Schweon', 'Affiliation': 'Infection Prevention Consultant, Saylorsburg, Pennsylvania.'}, {'ForeName': 'Gulsum', 'Initials': 'G', 'LastName': 'Anderson', 'Affiliation': 'Division of Geriatric Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'Division of Geriatric Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.1256']
166,32391894,Effect of Viewing Disney Movies During Chemotherapy on Self-Reported Quality of Life Among Patients With Gynecologic Cancer: A Randomized Clinical Trial.,"Importance


In addition to treatment efficacy, evaluation of adverse effects and quality of life assessments have become increasingly relevant in oncology.
Objective


To evaluate the association of watching Disney movies during chemotherapy with emotional and social functioning and fatigue status.
Design, Setting, and Participants


This randomized clinical trial was performed from December 2017 to December 2018 at a cancer referral center in Vienna, Austria. A consecutive sample of women with gynecologic cancers was recruited through July 2018. Inclusion criteria included age older than 18 years, written informed consent, and planned 6 cycles of chemotherapy with either carboplatin and paclitaxel or carboplatin and pegylated liposomal doxorubicin. Exclusion criteria were inadequate knowledge of the German language or receipt of other chemotherapy regimens. Data analysis was performed from February 2019 to April 2019.
Intervention


Participants were either shown Disney movies or not during 6 cycles of chemotherapy. Before and after every cycle, they completed standardized questionnaires from the European Organisation for Research and Treatment of Cancer (EORTC).
Main Outcomes and Measures


Primary outcomes were change of quality of life, as defined by the EORTC Core-30 (version 3) questionnaire, and fatigue, as defined by the EORTC Quality of Life Questionnaire Fatigue, during 6 cycles of chemotherapy.
Results


Fifty-six women entered the study, and 50 completed it, including 25 women in the Disney group (mean [SD] age, 59 [12] years) and 25 women in the control group (mean [SD] age, 62 [8] years). In the course of 6 cycles of chemotherapy, patients in the Disney group felt less tense and worried less than patients in the control group according to their responses to the questions about emotional functioning (mean [SD] score, 86.9 [14.3] vs 66.3 [27.2]; maximum test P = .02). Furthermore, watching Disney movies was associated with less encroachment on patients' family life and social activities, as evaluated by the social functioning questions (mean [SD] score, 86.1 [23.0] vs 63.6 [33.6]; maximum test P = .01). Moreover, this intervention led to fewer fatigue symptoms (mean [SD] score, 85.5 [13.6] vs 66.4 [22.5]; maximum test P = .01). Perceived global health status was not associated with watching Disney movies (mean [SD] score, 75.9 [17.6] vs 61.0 [25.1]; maximum test P = .16).
Conclusions and Relevance


These findings suggest that watching Disney movies during chemotherapy may be associated with improvements in emotional functioning, social functioning, and fatigue status in patients with gynecologic cancers.
Trial Registration


ClinicalTrials.gov Identifier: NCT03863912.",2020,"Furthermore, watching Disney movies was associated with less encroachment on patients' family life and social activities, as evaluated by the social functioning questions (mean [SD] score, 86.1 [23.0] vs 63.6 [33.6]; maximum test P = .01).","['Inclusion criteria included age older than 18 years, written informed consent, and planned 6 cycles of chemotherapy with either', 'December 2017 to December 2018 at a cancer referral center in Vienna, Austria', 'women with gynecologic cancers was recruited through July 2018', 'Patients With Gynecologic Cancer', 'patients with gynecologic cancers', 'Fifty-six women entered the study, and 50 completed it, including 25 women in the Disney group (mean [SD] age, 59 [12] years) and 25 women in the control group (mean [SD] age, 62 [8] years']","['Viewing Disney Movies', 'carboplatin and paclitaxel or carboplatin and pegylated liposomal doxorubicin']","['Perceived global health status', 'Quality of Life', 'change of quality of life, as defined by the EORTC Core-30 (version 3) questionnaire, and fatigue, as defined by the EORTC Quality of Life Questionnaire Fatigue', 'emotional functioning, social functioning, and fatigue status', 'fatigue symptoms', ""patients' family life and social activities"", 'social functioning questions']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015608', 'cui_str': 'Family Relationship'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.15327,"Furthermore, watching Disney movies was associated with less encroachment on patients' family life and social activities, as evaluated by the social functioning questions (mean [SD] score, 86.1 [23.0] vs 63.6 [33.6]; maximum test P = .01).","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pils', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Ott', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Reinthaller', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Enikoe', 'Initials': 'E', 'LastName': 'Steiner', 'Affiliation': 'Department of Obstetrics and Gynecology, General Hospital of Vienna, Vienna, Austria.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Springer', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Ristl', 'Affiliation': 'Section for Medical Statistics, Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna, Vienna, Austria.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.4568']
167,32387531,The effect of presenting relative calorie information on calories ordered.,"In this research, we tested the effect of a novel method of presenting calorie information-highlighting relative differences in calories among ingredients. We conducted an online hypothetical food choice experiment where 633 participants selected the ingredients for a sandwich from five categories: meat/protein, cheese, spread/dressing, bread, and vegetables. Each participant was randomly assigned to one of four calorie information conditions: 1) a condition in which no information about calories was provided, 2) a condition in which calorie information was provided for each ingredient, 3) a condition in which calorie information was presented relative to the highest calorie item, and 4) a condition in which calorie information was presented relative to the lowest calorie item. Participants in the high- and low-calorie reference conditions ordered between 32 and 36 fewer calories per sandwich than participants in the no-calorie information control condition (p ≤ 0.04). Calories ordered by participants in the per-item calorie condition were not significantly different than the control. Presenting relative calorie or other nutritional information to make health-related trade-offs more salient may guide consumers to make healthier choices.",2020,Calories ordered by participants in the per-item calorie condition were not significantly different than the control.,"['633 participants selected the ingredients for a sandwich from five categories: meat/protein, cheese, spread/dressing, bread, and vegetables']","['condition in which no information about calories was provided, 2) a condition in which calorie information']",[],"[{'cui': 'C4543503', 'cui_str': 'Sandwich'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]",[],633.0,0.0417974,Calories ordered by participants in the per-item calorie condition were not significantly different than the control.,"[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Gustafson', 'Affiliation': 'Department of Agricultural Economics, University of Nebraska-Lincoln, 314A Filley Hall, Lincoln, NE, 68583, USA. Electronic address: cgustafson6@unl.edu.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Zeballos', 'Affiliation': 'USDA Economic Research Service, Food Economic Division, Washington, D.C, USA. Electronic address: eliana.zeballos@gmail.com.'}]",Appetite,['10.1016/j.appet.2020.104727']
168,32388632,Benefit of a nurse-led telephone-based intervention prior to the first urogynecology outpatient visit: a randomized-controlled trial.,"INTRODUCTION AND HYPOTHESIS


Triage has become a valid tool to reduce workload during the first consultation in a specialized clinic. A nurse-led telephone intervention prior to the first urogynecologic visit reduces visit duration and increases patients' and physicians' satisfaction.
METHODS


All patients scheduled for their very first visit were recruited. They were randomized into an intervention group (prior contact by a specialized urogynecology nurse) and a control group (no contact). The intervention included a questionnaire about history and symptoms. Patients were prompted to complete a bladder diary. Primary outcome was duration of the consultation; secondary outcomes were patients' and physicians' satisfaction with the intervention.
RESULTS


Fifty-five patients were allocated to the intervention group and 53 to the control group with no difference regarding age, BMI, parity, menopausal status and primary diagnosis. Mean duration of the telephone call was 10.8 min (SD 4.4). The consultation was significantly shorter in the intervention group than in the control group (mean difference: 4 min and 8 s, p = 0.017). In the intervention group, 79% of the patients found the consultation quality ""excellent,"" 86% would return, and 77% would recommend our clinic to a relative or friend compared with 68%, 67% and 66%, respectively, in the control group. Physicians were ""very satisfied"" or ""satisfied"" with the patient preparation.
CONCLUSIONS


A nurse-led intervention reduces the duration of the first uroynecologic consultation and is associated with high patient and physician satisfaction. Further research should evaluate whether it also decreases the number of follow-up visits and further referrals.",2020,"The consultation was significantly shorter in the intervention group than in the control group (mean difference: 4 min and 8 s, p = 0.017).","['Fifty-five patients', 'All patients scheduled for their very first visit were recruited']","['intervention group (prior contact by a specialized urogynecology nurse) and a control group (no contact', 'nurse-led telephone-based intervention']","['consultation quality ""excellent', ""duration of the consultation; secondary outcomes were patients' and physicians' satisfaction with the intervention"", 'Mean duration of the telephone call']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]",55.0,0.0525178,"The consultation was significantly shorter in the intervention group than in the control group (mean difference: 4 min and 8 s, p = 0.017).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Jimènez Torres', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Waehringer Guertel 18, 1090, Wien, Austria.'}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Beitl', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Waehringer Guertel 18, 1090, Wien, Austria.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Hummel Jimènez', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Waehringer Guertel 18, 1090, Wien, Austria.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Mayer', 'Affiliation': 'Department of Nursing Sciences, University of Vienna, Alser Straße 23, 1080, Wien, Austria.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Zehetmayer', 'Affiliation': 'Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna, Spitalgasse 23, 1090, Wien, Austria.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Umek', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Waehringer Guertel 18, 1090, Wien, Austria. wolfgang.umek@meduniwien.ac.at.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Veit-Rubin', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Waehringer Guertel 18, 1090, Wien, Austria.'}]",International urogynecology journal,['10.1007/s00192-020-04318-0']
169,32388650,Effects of intraoperative positive end-expiratory pressure optimization on respiratory mechanics and the inflammatory response: a randomized controlled trial.,"Applying lung protective mechanical ventilation (LPV) during general anaesthesia even in patients with non-injured lungs is recommended. However, the effects of an individual PEEP-optimisation on respiratory mechanics, oxygenation and their potential correlation with the inflammatory response and postoperative complications have not been evaluated have not been compared to standard LPV in patients undergoing major abdominal surgery. Thirty-nine patients undergoing open radical cystectomy were enrolled in this study. In the study group (SG) optimal PEEP was determined by a decremental titration procedure and defined as the PEEP value resulting the highest static pulmonary compliance. In the control group (CG) PEEP was set to 6 cmH2O. Primary endpoints were intraoperative respiratory mechanics and gas exchange parameters. Secondary outcomes were perioperative procalcitonin kinetics and postoperative pulmonary complications. Optimal PEEP levels (median = 10, range: 8-14 cmH2O), PaO2/FiO2 (451.24 ± 121.78 mmHg vs. 404.15 ± 115.87 mmHg, P = 0.005) and static pulmonary compliance (52.54 ± 13.59 ml cmH2O-1 vs. 45.22 ± 9.13 ml cmH2O-1, P < 0.0001) were significantly higher, while driving pressure (8.26 ± 1.74 cmH2O vs. 9.73 ± 4.02 cmH2O, P < 0.0001) was significantly lower in the SG as compared to the CG. No significant intergroup differences were found in procalcitonin kinetics (P = 0.076). Composite outcome results indicated a non-significant reduction of postoperative complications in the SG. Intraoperative PEEP-optimization resulted in significant improvement in gas exchange and pulmonary mechanics as compared to standard LPV. Whether these have any effect on short and long term outcomes require further investigations. Trial registration: Clinicaltrials.gov, identifier: NCT02931409.",2020,No significant intergroup differences were found in procalcitonin kinetics (P = 0.076).,"['patients undergoing major abdominal surgery', 'Thirty-nine patients undergoing', 'patients with non-injured lungs']","['open radical cystectomy', 'intraoperative positive end-expiratory pressure optimization', 'lung protective mechanical ventilation (LPV', 'Intraoperative PEEP-optimization', 'individual PEEP-optimisation']","['intraoperative respiratory mechanics and gas exchange parameters', 'procalcitonin kinetics', 'driving pressure', 'postoperative complications', 'static pulmonary compliance', 'gas exchange and pulmonary mechanics', 'Optimal PEEP levels', 'perioperative procalcitonin kinetics and postoperative pulmonary complications', 'respiratory mechanics and the inflammatory response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",39.0,0.0974141,No significant intergroup differences were found in procalcitonin kinetics (P = 0.076).,"[{'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Ruszkai', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Pest Megyei Flór Ferenc Hospital, Semmelweis Square 1, Kistarcsa, 2143, Hungary. z.ruszkai.md@gmail.com.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Kiss', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, University of Szeged, Semmelweis Street 6, Szeged, 6725, Hungary.'}, {'ForeName': 'Ildikó', 'Initials': 'I', 'LastName': 'László', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, University of Szeged, Semmelweis Street 6, Szeged, 6725, Hungary.'}, {'ForeName': 'Gergely Péter', 'Initials': 'GP', 'LastName': 'Bokrétás', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Péterfy Sándor Hospital, Péterfy Sándor Street 8-20, Budapest, 1076, Hungary.'}, {'ForeName': 'Dóra', 'Initials': 'D', 'LastName': 'Vizserálek', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Péterfy Sándor Hospital, Péterfy Sándor Street 8-20, Budapest, 1076, Hungary.'}, {'ForeName': 'Ildikó', 'Initials': 'I', 'LastName': 'Vámossy', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Péterfy Sándor Hospital, Péterfy Sándor Street 8-20, Budapest, 1076, Hungary.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Surány', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Péterfy Sándor Hospital, Péterfy Sándor Street 8-20, Budapest, 1076, Hungary.'}, {'ForeName': 'István', 'Initials': 'I', 'LastName': 'Buzogány', 'Affiliation': 'Department of Urology, Péterfy Sándor Hospital, Péterfy Sándor Street 8-20, Budapest, 1076, Hungary.'}, {'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Bajory', 'Affiliation': 'Department of Urology, University of Szeged, Kálvária Avenue 57, Szeged, 6725, Hungary.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Molnár', 'Affiliation': 'Centre for Translational Medicine, University of Pécs, Szigeti Street 12, Pécs, 7624, Hungary.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-020-00519-6']
170,32393559,Efficacy of Intra-Articular Hypertonic Dextrose (Prolotherapy) for Knee Osteoarthritis: A Randomized Controlled Trial.,"PURPOSE


To test the efficacy of intra-articular hypertonic dextrose prolotherapy (DPT) vs normal saline (NS) injection for knee osteoarthritis (KOA).
METHODS


A single-center, parallel-group, blinded, randomized controlled trial was conducted at a university primary care clinic in Hong Kong. Patients with KOA (n = 76) were randomly allocated (1:1) to DPT or NS groups for injections at weeks 0, 4, 8, and 16. The primary outcome was the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 0-100 points) pain score. The secondary outcomes were the WOMAC composite, function and stiffness scores; objectively assessed physical function test results; visual analogue scale (VAS) for knee pain; and EuroQol-5D score. All outcomes were evaluated at baseline and at 16, 26, and 52 weeks using linear mixed model.
RESULTS


Randomization produced similar groups. The WOMAC pain score at 52 weeks showed a difference-in-difference estimate of -10.34 (95% CI, -19.20 to -1.49,  P  = 0.022) points. A similar favorable effect was shown on the difference-in-difference estimate on WOMAC function score of -9.55 (95% CI, -17.72 to -1.39,  P  = 0.022), WOMAC composite score of -9.65 (95% CI, -17.77 to -1.53,  P  = 0.020), VAS pain intensity score of -10.98 (95% CI, -21.36 to -0.61,  P  = 0.038), and EuroQol-5D VAS score of 8.64 (95% CI, 1.36 to 5.92,  P  = 0.020). No adverse events were reported.
CONCLUSION


Intra-articular dextrose prolotherapy injections reduced pain, improved function and quality of life in patients with KOA compared with blinded saline injections. The procedure is straightforward and safe; the adherence and satisfaction were high.",2020,"CONCLUSION


Intra-articular dextrose prolotherapy injections reduced pain, improved function and quality of life in patients with KOA compared with blinded saline injections.","['Patients with KOA (n = 76', 'Knee Osteoarthritis', 'university primary care clinic in Hong Kong', 'patients with KOA', 'knee osteoarthritis (KOA']","['DPT or NS', 'Intra-Articular Hypertonic Dextrose (Prolotherapy', 'intra-articular hypertonic dextrose prolotherapy (DPT) vs normal saline (NS) injection']","['EuroQol-5D VAS score', 'WOMAC composite score', 'WOMAC function score', 'pain, improved function and quality of life', 'Western Ontario McMaster University Osteoarthritis Index (WOMAC; 0-100 points) pain score', 'WOMAC composite, function and stiffness scores; objectively assessed physical function test results; visual analogue scale (VAS) for knee pain; and EuroQol-5D score', 'adverse events', 'WOMAC pain score', 'VAS pain intensity score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0500223', 'cui_str': 'Prolotherapy'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",76.0,0.385251,"CONCLUSION


Intra-articular dextrose prolotherapy injections reduced pain, improved function and quality of life in patients with KOA compared with blinded saline injections.","[{'ForeName': 'Regina Wing', 'Initials': 'RW', 'LastName': 'Shan Sit', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong reginasit@cuhk.edu.hk.'}, {'ForeName': 'Ricky Wing', 'Initials': 'RW', 'LastName': 'Keung Wu', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rabago', 'Affiliation': 'Department of Family Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Kenneth Dean', 'Initials': 'KD', 'LastName': 'Reeves', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Dicken Cheong', 'Initials': 'DC', 'LastName': 'Chun Chan', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Benjamin Hon', 'Initials': 'BH', 'LastName': 'Kei Yip', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Vincent Chi', 'Initials': 'VC', 'LastName': 'Ho Chung', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Samuel Yeung', 'Initials': 'SY', 'LastName': 'Shan Wong', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong.'}]",Annals of family medicine,['10.1370/afm.2520']
171,32393614,Can a teacher-led mindfulness intervention for new school entrants improve child outcomes? Protocol for a school cluster randomised controlled trial.,"INTRODUCTION


The first years of school are critical in establishing a foundation for positive long-term academic, social and well-being outcomes. Mindfulness-based interventions may help students transition well into school, but few robust studies have been conducted in this age group. We aim to determine whether compared with controls, children who receive a mindfulness intervention within the first years of primary school have better: (1) immediate attention/short-term memory at 18 months post-randomisation (primary outcome); (2) inhibition, working memory and cognitive flexibility at 18 months post-randomisation; (3) socio-emotional well-being, emotion-regulation and mental health-related behaviours at 6 and 18 months post-randomisation; (4) sustained changes in teacher practice and classroom interactions at 18 months post-randomisation. Furthermore, we aim to determine whether the implementation predicts the efficacy of the intervention, and the cost effectiveness relative to outcomes.
METHODS AND ANALYSIS


This cluster randomised controlled trial will be conducted in 22 primary schools in disadvantaged areas of Melbourne, Australia. 826 students in the first year of primary school will be recruited to detect between groups differences of Cohen's d=0.25 at the 18-month follow-up. Parent, teacher and child-assessment measures of child attention, emotion-regulation, executive functioning, socio-emotional well-being, mental health-related behaviour and learning, parent mental well-being, teacher well-being will be collected 6 and 18 months post-randomisation. Implementation factors will be measured throughout the study. Intention-to-treat analyses, accounting for clustering within schools and classes, will adopt a two-level random effects linear regression model to examine outcomes for the intervention versus control students. Unadjusted and analyses adjusted for baseline scores, baseline age, gender and family socioeconomic status will be conducted.
ETHICS AND DISSEMINATION


Ethics approval has been received by the Human Research Ethics Committee at the University of Melbourne. Findings will be reported in peer-review publications, national and international conference presentations and research snapshots directly provided to participating schools and families.
PRE-RESULTS TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (ACTRN12619000326190).",2020,"The first years of school are critical in establishing a foundation for positive long-term academic, social and well-being outcomes.","[""826 students in the first year of primary school will be recruited to detect between groups differences of Cohen's d=0.25 at the 18-month follow-up"", '22 primary schools in disadvantaged areas of Melbourne, Australia']","['mindfulness intervention within the first years of primary school have better: (1) immediate attention/short-term memory at 18 months post-randomisation (primary outcome); (2) inhibition, working memory and cognitive flexibility at 18 months post-randomisation; (3) socio-emotional well-being, emotion-regulation and mental health-related behaviours at 6 and 18 months post-randomisation; (4) sustained changes in teacher practice and classroom interactions']","['child attention, emotion-regulation, executive functioning, socio-emotional well-being, mental health-related behaviour and learning, parent mental well-being, teacher well-being']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]",826.0,0.172604,"The first years of school are critical in establishing a foundation for positive long-term academic, social and well-being outcomes.","[{'ForeName': 'Jon L', 'Initials': 'JL', 'LastName': 'Quach', 'Affiliation': 'Melbourne Graduate School of Education, The University of Melbourne, Carlton, Victoria, Australia jon.quach@unimelb.edu.au.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Deery', 'Affiliation': 'Melbourne Graduate School of Education, The University of Melbourne, Carlton, Victoria, Australia.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Kern', 'Affiliation': 'Melbourne Graduate School of Education, The University of Melbourne, Carlton, Victoria, Australia.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Clinton', 'Affiliation': 'Melbourne Graduate School of Education, The University of Melbourne, Carlton, Victoria, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Gold', 'Affiliation': 'Deakin Health Economics, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Orsini', 'Affiliation': 'Clinical Epidemiology and Biostatistics Unit, Murdoch Childrens Research Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sciberras', 'Affiliation': 'Centre for Community Child Health, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-036523']
172,32393616,Correction: Acupuncture for insomnia with short sleep duration: protocol for a randomised controlled trial.,,2020,,['insomnia with short sleep duration'],['Correction: Acupuncture'],[],"[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]",[],,0.208285,,[],BMJ open,['10.1136/bmjopen-2019-033731corr1']
173,32330670,Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS) to increase evidence based psychotherapy in military behavioral health clinics: Design of a cluster-randomized stepped-wedge implementation study.,"BACKGROUND


Despite efforts by the U.S. Department of Defense to train behavioral health (BH) providers in evidence-based psychotherapies (EBPs) for posttraumatic stress disorder (PTSD), numerous barriers limit EBP implementation. A context-tailored implementation approach called TACTICS (Targeted Assessment and Context-Tailored Implementation of Change Strategies) holds promise for increasing the use of EBPs such as prolonged exposure therapy (PE) in military treatment facilities. TACTICS combines a needs assessment, a rubric for selecting implementation strategies based on local barriers, an implementation toolkit, and external facilitation to support local champions and their implementation teams in enacting changes. This paper describes the rationale for and design of a study that will evaluate whether TACTICS can increase implementation of PE for PTSD and improve patient outcomes in military BH clinics relative to provider training in PE alone.
METHODS


The study is a multi-site, cluster randomized, stepped-wedge trial, with the military treatment facility as the unit of analysis. Eight facilities undergo a provider-training phase, followed by 5 months of TACTICS implementation. The timing of TACTICS at each facility is randomly assigned to begin 9, 14, or 19 months after beginning the provider-training phase. Primary analyses will compare the proportion of PTSD patients receiving PE and patients' mean improvement in PTSD symptoms before and after the onset of TACTICS.
DISCUSSION


TACTICS endeavors to balance standardization of empirically-supported implementation strategies with the flexibility of application necessary for success across varied clinical settings. If successful, TACTICS may represent a systematic and scalable method of promoting and supporting EBP implementation.
TRIAL REGISTRATION


Clinicaltrials.gov Identifier: NCT03663452.",2020,A context-tailored implementation approach called TACTICS (Targeted Assessment and Context-Tailored Implementation of Change Strategies) holds promise for increasing the use of EBPs such as prolonged exposure therapy (PE) in military treatment facilities.,"['military BH clinics relative to provider training in PE alone', 'military behavioral health clinics']",[],['PTSD symptoms'],"[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]",[],"[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0549177,A context-tailored implementation approach called TACTICS (Targeted Assessment and Context-Tailored Implementation of Change Strategies) holds promise for increasing the use of EBPs such as prolonged exposure therapy (PE) in military treatment facilities.,"[{'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Rosen', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, 795 Willow Rd, Menlo Park, CA, United States of America; Department of Psychiatry and Behavioral Sciences, Stanford University, 401 Quarry Rd, Palo Alto, CA 94305, United States of America. Electronic address: craig.rosen@va.gov.'}, {'ForeName': 'C Adrian', 'Initials': 'CA', 'LastName': 'Davis', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, 795 Willow Rd, Menlo Park, CA, United States of America. Electronic address: carrie.davis6@va.gov.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Riggs', 'Affiliation': 'Center for Deployment Psychology, Department of Medical and Clinical Psychology, Uniformed Services University of the Health Sciences, 4301 Jones Bridge Rd, Bethesda, MD 20814, United States of America. Electronic address: driggs@deploymentpsych.org.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'Center for Deployment Psychology, Department of Medical and Clinical Psychology, Uniformed Services University of the Health Sciences, 4301 Jones Bridge Rd, Bethesda, MD 20814, United States of America. Electronic address: jcook@deploymentpsych.org.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States of America; Research and Development Service, South Texas Veterans Health Care System, 7400 Merton Minter Blvd, San Antonio, TX 78229, United States of America; Department of Psychology, University of Texas at San Antonio, One UTSA Circle, San Antonio, TX 78249, United States of America. Electronic address: petersona3@uthscsa.edu.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States of America. Electronic address: youngs1@uthscsa.edu.'}, {'ForeName': 'Katherine Anne', 'Initials': 'KA', 'LastName': 'Comtois', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, 1959 NE Pacific St, Seattle, WA 98195, United States of America. Electronic address: kcomtois@uw.edu.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Haddock', 'Affiliation': 'Social Sciences Innovations Corporation, 71 W 23rd St 4th Floor, New York, NY 10010, United States of America. Electronic address: keithhaddock@hopehri.com.'}, {'ForeName': 'Elisa V', 'Initials': 'EV', 'LastName': 'Borah', 'Affiliation': 'University of Texas at Austin, Steve Hicks School of Social Work, 1925 San Jacinto Blvd, Austin, TX 78712, United States of America. Electronic address: Elisa.Borah@austin.utexas.edu.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Dondanville', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States of America. Electronic address: Dondanville@uthscsa.edu.'}, {'ForeName': 'Erin P', 'Initials': 'EP', 'LastName': 'Finley', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States of America; Department of Medicine, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States of America; Veterans Evidence-based Research Dissemination and Implementation Center (VERDICT), South Texas Veterans Health Care System, 7400 Merton Minter Blvd, San Antonio, TX 78229, United States of America. Electronic address: finleye@uthscsa.edu.'}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Jahnke', 'Affiliation': 'Social Sciences Innovations Corporation, 71 W 23rd St 4th Floor, New York, NY 10010, United States of America. Electronic address: sara@hopehri.com.'}, {'ForeName': 'Walker S C', 'Initials': 'WSC', 'LastName': 'Poston', 'Affiliation': 'Social Sciences Innovations Corporation, 71 W 23rd St 4th Floor, New York, NY 10010, United States of America. Electronic address: carlosposton@hopehri.com.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Wiltsey-Stirman', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, 795 Willow Rd, Menlo Park, CA, United States of America; Department of Psychiatry and Behavioral Sciences, Stanford University, 401 Quarry Rd, Palo Alto, CA 94305, United States of America. Electronic address: sws1@stanford.edu.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Neitzer', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, 795 Willow Rd, Menlo Park, CA, United States of America. Electronic address: andrea.neitzer@va.gov.'}, {'ForeName': 'Capt Rachel', 'Initials': 'CR', 'LastName': 'Broussard', 'Affiliation': 'David Grant United States Air Force Medical Center, Travis Air Force Base, 101 Bodin Cir, Fairfield, CA, 94533, United States of America. Electronic address: rachel.a.broussard2.mil@mail.mil.'}, {'ForeName': 'Maj Amy', 'Initials': 'MA', 'LastName': 'Brzuchalski', 'Affiliation': 'William Beaumont Army Medical Center, Ft. Bliss, 5005 N Piedras St, El Paso, TX 79920, United States of America. Electronic address: amy.e.brzuchalski.mil@mail.mil.'}, {'ForeName': 'Maj Spencer P', 'Initials': 'MSP', 'LastName': 'Clayton', 'Affiliation': '49th Medical Group, Holloman Air Force Base, 280 1st St, Alamogordo, NM 88330, United States of America. Electronic address: spencer.p.clayton.mil@mail.mil.'}, {'ForeName': 'Lt Allison M', 'Initials': 'LAM', 'LastName': 'Conforte', 'Affiliation': 'Naval Hospital Jacksonville, Naval Air Station Jacksonville, 2080 Child St, Jacksonville, FL 32214, United States of America. Electronic address: allison.m.conforte.mil@mail.mil.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'Flores', 'Affiliation': 'William Beaumont Army Medical Center, Ft. Bliss, 5005 N Piedras St, El Paso, TX 79920, United States of America. Electronic address: araceli.flores8.civ@mail.mil.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hein', 'Affiliation': 'Blanchfield Army Community Hospital, Ft. Campbell, 650 Joel Dr, Fort Campbell, KY 42223, United States of America. Electronic address: jessica.l.hein.civ@mail.mil.'}, {'ForeName': 'Capt Felicia', 'Initials': 'CF', 'LastName': 'Keith', 'Affiliation': 'David Grant United States Air Force Medical Center, Travis Air Force Base, 101 Bodin Cir, Fairfield, CA, 94533, United States of America. Electronic address: felicia.a.keith.mil@mail.mil.'}, {'ForeName': 'Capt Jeremy', 'Initials': 'CJ', 'LastName': 'Jinkerson', 'Affiliation': '81st Medical Group, Keesler Air Force Base, 500 Fisher St, Biloxi, MS 39534, United States of America. Electronic address: jeremy.d.jinkerson.mil@mail.mil.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Letendre', 'Affiliation': 'Bassett Army Community Hospital, Ft. Wainwright, 4076 Neely Rd, Fairbanks, AK 99703, United States of America. Electronic address: margaret.a.letendre.civ@mail.mil.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Nofziger', 'Affiliation': 'Brooke Army Medical Center, Joint Base San Antonio-Ft. Sam Houston, 3551 Roger Brooke Dr, San Antonio, TX, 78234, United States of America. Electronic address: debra.l.nofziger.ctr@mail.mil.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Pollick', 'Affiliation': 'Naval Hospital Jacksonville, Naval Air Station Jacksonville, 2080 Child St, Jacksonville, FL 32214, United States of America. Electronic address: kirsten.m.pollick2.civ@mail.mil.'}, {'ForeName': 'Capt Kyra', 'Initials': 'CK', 'LastName': 'Santiago', 'Affiliation': '49th Medical Group, Holloman Air Force Base, 280 1st St, Alamogordo, NM 88330, United States of America. Electronic address: kyra.t.santiago.mil@mail.mil.'}, {'ForeName': 'Lt Col John', 'Initials': 'LCJ', 'LastName': 'Waggoner', 'Affiliation': '81st Medical Group, Keesler Air Force Base, 500 Fisher St, Biloxi, MS 39534, United States of America. Electronic address: john.w.waggoner6.mil@mail.mil.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Woodworth', 'Affiliation': 'Brooke Army Medical Center, Joint Base San Antonio-Ft. Sam Houston, 3551 Roger Brooke Dr, San Antonio, TX, 78234, United States of America. Electronic address: craig.a.woodworth.civ@mail.mil.'}, {'ForeName': 'Carmen P', 'Initials': 'CP', 'LastName': 'McLean', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, 795 Willow Rd, Menlo Park, CA, United States of America; Department of Psychiatry and Behavioral Sciences, Stanford University, 401 Quarry Rd, Palo Alto, CA 94305, United States of America. Electronic address: carmen.mclean4@va.gov.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106008']
174,32278195,Cardiorespiratory responses to fine particles during ambient PM 2.5  pollution waves: Findings from a randomized crossover trial in young healthy adults.,"BACKGROUND


PM 2.5  pollution waves (PPWs) are severe air pollution events with extremely high-level concentration of ambient PM 2.5 . PPWs, such as haze days, were suggested to be associated with increased cardiopulmonary mortality and morbidity. However, the biological mechanism response to ambient PM 2.5  during PPWs is still unclear.
METHODS


A randomized crossover trial was conducted on 29 healthy young adults. Repeated health measurements were performed before, during and after two typical PPWs under filtered and sham indoor air purification, with a washout interval of at least 2 weeks. Health parameters including blood pressure (BP), pulmonary function, fractional exhaled nitric oxide (FeNO) and circulating biomarkers which reflect platelet activation, blood coagulation and systematic oxidative stress were measured.
RESULTS


Ambient PM 2.5  levels elevated apparently during PPWs. Under sham purification, significant increase in FeNO and soluble P-selectin (sP-selectin) and decreases in pulmonary function were observed from pre-PPWs period to during-PPWs period. The changes in health biomarkers as mentioned above became attenuated and insignificant under filtered condition. For instance, sP-selectin increased by 12.0% (95% CI: 3.8%, 20.8%) during-PPWs periods compared with pre-PPWs periods under sham purification, while non-significant change was observed under filtered condition. Significant associations between time-weighted personal PM 2.5  exposure and increased levels of health biomarkers including FeNO, sP-selectin, oxidized low-density lipoprotein (ox-LDL) and 8-isoprostane (8-isoPGF2α) were found.
CONCLUSION


PPWs could affect cardiopulmonary health through systematic oxidative stress, platelet activation and respiratory inflammation in healthy adults, and short-term indoor air purification could alleviate the adverse cardiopulmonary effects.",2020,"Significant associations between time-weighted personal PM 2.5  exposure and increased levels of health biomarkers including FeNO, sP-selectin, oxidized low-density lipoprotein (ox-LDL) and 8-isoprostane (8-isoPGF2α) were found.
","['healthy adults', 'young healthy adults', '29 healthy young adults']",[],"['blood pressure (BP), pulmonary function, fractional exhaled nitric oxide (FeNO) and circulating biomarkers which reflect platelet activation, blood coagulation and systematic oxidative stress', 'levels of health biomarkers including FeNO, sP-selectin, oxidized low-density lipoprotein (ox-LDL) and 8-isoprostane (8-isoPGF2α', 'FeNO and soluble P-selectin (sP-selectin', 'cardiopulmonary mortality and morbidity', 'health biomarkers', 'Cardiorespiratory responses', 'sP-selectin', 'pulmonary function']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],"[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0032173', 'cui_str': 'Platelet activation'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282651', 'cui_str': 'Selectins'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0295541', 'cui_str': '8-isoprostaglandin F2alpha'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",29.0,0.0335382,"Significant associations between time-weighted personal PM 2.5  exposure and increased levels of health biomarkers including FeNO, sP-selectin, oxidized low-density lipoprotein (ox-LDL) and 8-isoprostane (8-isoPGF2α) were found.
","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Xue', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Minghao', 'Initials': 'M', 'LastName': 'Kou', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Zemin', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Shaowei', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China. Electronic address: jing_huang@bjmu.edu.cn.'}, {'ForeName': 'Xinbiao', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China. Electronic address: guoxb@bjmu.edu.cn.'}]",Environment international,['10.1016/j.envint.2020.105590']
175,32305787,A prospective randomized controlled study of combined spinal-general anesthesia vs. general anesthesia for laparoscopic gynecological surgery: Opioid sparing properties.,"STUDY OBJECTIVE


We aimed to determine the magnitude of peri-operative opioid sparing effect when general anesthesia is combined with spinal analgesia for laparoscopic gynecological surgery.
DESIGN


A prospective randomized controlled study; a three-group trial with two comparisons (each intervention group to control).
SETTING


Operating room and postoperative recovery area.
PATIENTS


Patients aged between 18 and 65 years with American Society of Anesthesiologists physical status 1 or 2 who were scheduled for inpatient elective laparoscopic gynecological surgery with expected pneumoperitoneum duration of at least 20 min. Of 102 randomized patients, 99 completed the study.
INTERVENTIONS


Patients were randomized to general anesthesia alone (control group) or combined with very-low-dose (levobupivacaine 3.75 mg; sufentanil 2.5 μg) or low-dose (levobupivacaine 7.5 mg; sufentanil 2.5 μg) spinal analgesia.
MEASUREMENTS


Primary endpoints were perioperative opioid consumption and pain scores (11-point numeric rating scale) at 30 min, 1 h, 2 h, 4 h and 24 h post-surgery. Secondary endpoints were patient satisfaction with anesthetic care and participation in research, sevoflurane consumption and adverse effects.
MAIN RESULTS


Intra-operative sufentanil (median [95% CI]) consumption was 16.1 (10.5-22.6) μg/h in the control group versus 4.7 (3.2-9.2) μg/h in the very-low-dose and versus 2.9 (0.0-4.0) μg/h in the low-dose spinal analgesia groups (p < 0.001, for both comparisons). Median (95% CI) piritramide consumption at 24 h post-surgery was 7.5 (3-8) mg in the control group versus 5 (0-7.5) mg in the very-low dose spinal analgesia group (p = 0.182) and versus 2 (0-2.5) mg in the low-dose spinal analgesia group (p = 0.001). Postoperative pain scores were consistently <3 only in the low dose spinal analgesia group. Patient satisfaction with anesthetic care and participation in research was very high in all groups.
CONCLUSIONS


Low-dose spinal analgesia in combination with general anesthesia reduces peri-operative opioid consumption in laparoscopic gynecological surgery in immediate postoperative period.",2020,"CONCLUSIONS


Low-dose spinal analgesia in combination with general anesthesia reduces peri-operative opioid consumption in laparoscopic gynecological surgery in immediate postoperative period.","['102 randomized patients, 99 completed the study', 'laparoscopic gynecological surgery', 'Patients aged between 18 and 65\xa0years with American Society of Anesthesiologists physical status 1 or 2 who were scheduled for inpatient elective laparoscopic gynecological surgery with expected pneumoperitoneum duration of at least 20\xa0min']","['combined spinal-general anesthesia vs. general anesthesia', 'spinal analgesia', 'general anesthesia alone (control group) or combined with very-low-dose (levobupivacaine 3.75\xa0mg; sufentanil 2.5\xa0μg) or low-dose (levobupivacaine 7.5\xa0mg; sufentanil 2.5\xa0μg) spinal analgesia']","['Postoperative pain scores', 'perioperative opioid consumption and pain scores (11-point numeric rating scale) at 30\xa0min, 1\xa0h, 2\xa0h, 4\xa0h and 24\xa0h post-surgery', 'peri-operative opioid consumption', 'patient satisfaction with anesthetic care and participation in research, sevoflurane consumption and adverse effects', 'piritramide consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C1963862', 'cui_str': 'Spinal analgesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C4517697', 'cui_str': '3.75'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C4517859', 'cui_str': '7.5'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0031982', 'cui_str': 'Pirinitramide'}]",102.0,0.196443,"CONCLUSIONS


Low-dose spinal analgesia in combination with general anesthesia reduces peri-operative opioid consumption in laparoscopic gynecological surgery in immediate postoperative period.","[{'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Zdravkovic', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Management, University Medical Centre Maribor, Ljubljanska ulica 5, 2000 Maribor, Slovenia; Faculty of Medicine, University of Maribor, Taborska ulica 8, 2000 Maribor, Slovenia. Electronic address: markozdravkovic@gmail.com.'}, {'ForeName': 'Mirt', 'Initials': 'M', 'LastName': 'Kamenik', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Management, University Medical Centre Maribor, Ljubljanska ulica 5, 2000 Maribor, Slovenia; Faculty of Medicine, University of Maribor, Taborska ulica 8, 2000 Maribor, Slovenia.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109808']
176,32305794,Hemodynamic profiles with and without left uterine displacement: A randomized study in term pregnancies receiving subarachnoid blockade for cesarean delivery.,"STUDY OBJECTIVE


The aim of this study was to evaluate the effect of left uterine displacement (LUD) on maternal hemodynamic measures following subarachnoid blockade (SAB) for cesarean delivery (CD). The primary outcome was cardiac output (CO) differences between the LUD and non-LUD groups pre-delivery.
DESIGN


Prospective, randomized, controlled study.
SETTING


Obstetric operating room.
MATERIALS AND METHODS


We studied hemodynamic profiles in sixty healthy women with term pregnancies who underwent elective CD with SAB. Hemodynamics were measured using a non-invasive CO monitor, the Nexfin™. All women received a crystalloid 10 mL/kg preload, and hypotension was treated with ephedrine boluses.
INTERVENTIONS


Sixty women with term pregnancies were randomized into two groups: LUD group (received 15-30° LUD after SAB, n = 30) and non-LUD group (no LUD after SAB, n = 30).
MEASUREMENTS


Patient's hemodynamic variables including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), CO, systemic vascular resistance (SVR), and left ventricular contractility index (dP/dT) were measured continuously from pre-SAB until end of surgery.
MAIN RESULTS


In pre-delivery phase at 5 min after spinal anesthesia, the LUD group had significantly higher CO (7.20 ± 1.78 [95%CI 6.53-7.87] vs. 6.23 ± 1.44 L/min [95% CI 5.69-6.77]; p = 0.016) and higher dP/dT (784 ± 313 vs. 604 ± 241 mmHg/s; p = 0.020) than the non-LUD group. The LUD group had a lower incidence of maternal systolic hypotension at 5-min post-SAB (16.7% vs. 53.3% in non-LUD group, p = 0.003).
CONCLUSIONS


The study demonstrates modest hemodynamic advantages (higher CO, less hypotension, higher dP/dT) with pre-delivery LUD. The results support maternal hemodynamic benefits of LUD until delivery in women with term pregnancies undergoing CD with SAB.",2020,"The LUD group had a lower incidence of maternal systolic hypotension at 5-min post-SAB (16.7% vs. 53.3% in non-LUD group, p = 0.003).
","['sixty healthy women with term pregnancies who underwent elective CD with SAB', 'Sixty women with term pregnancies', 'Obstetric operating room', 'term pregnancies receiving subarachnoid blockade for cesarean delivery', 'women with term pregnancies undergoing CD with SAB', 'cesarean delivery (CD', '313 vs. 604\xa0±', '241', 'Hemodynamic profiles with and without left uterine displacement']","['ephedrine boluses', 'left uterine displacement (LUD', 'crystalloid 10\xa0mL/kg preload, and hypotension', 'subarachnoid blockade (SAB', 'LUD group (received 15-30° LUD after SAB, n\xa0=\xa030) and non-LUD']","['cardiac output (CO) differences', 'maternal hemodynamic measures', 'CO', 'systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), CO, systemic vascular resistance (SVR), and left ventricular contractility index (dP/dT', 'maternal systolic hypotension']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232991', 'cui_str': 'Term pregnancy'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0038527', 'cui_str': 'Subarachnoid space structure'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}]","[{'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0038527', 'cui_str': 'Subarachnoid space structure'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]",60.0,0.185135,"The LUD group had a lower incidence of maternal systolic hypotension at 5-min post-SAB (16.7% vs. 53.3% in non-LUD group, p = 0.003).
","[{'ForeName': 'Yanipan', 'Initials': 'Y', 'LastName': 'Chungsamarnyart', 'Affiliation': 'Department of Anesthesiology, Phramongkutklao Hospital, Bangkok, Thailand.'}, {'ForeName': 'Petch', 'Initials': 'P', 'LastName': 'Wacharasint', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Phramongkutklao Hospital, Bangkok, Thailand.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Carvalho', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, USA. Electronic address: bcarvalho@stanford.edu.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109796']
177,32325415,Whole-body vibration and stretching enhances dorsiflexion range of motion in individuals with chronic ankle instability.,"OBJECTIVE


The purpose of this study was to determine if WBV performed concurrently with static stretching was more effective than static stretching alone to increase dorsiflexion ROM (DFROM) in individuals with chronic ankle instability (CAI).
DESIGN


Controlled laboratory study.
PARTICIPANTS


Thirty-nine participants with CAI (history of ankle sprain, a feeling of ""giving way"" during activity, and a qualifying Foot and Ankle Ability Measure Ankle score) were divided into 3 groups (normative (N), static stretch (SS), and static stretch with vibration (SV)). Participants stretched the triceps surae 4 days/wk for 3 wks. Vibration was imposed at 34 Hz and 1.8 mm.
MAIN OUTCOME MEASURES


DFROM was assessed in a straight and bent-leg position.
RESULTS


No differences were detected at any time in the N or SS group, however SS did exhibit large effect sizes with 95% confidence intervals (CI) that did not cross zero from baseline to 3 weeks for both measures. The SV group demonstrated increased DFROM from baseline for both time points and a large effect size with 95% CI that did not cross zero from post tx-1 to post tx-2.
CONCLUSIONS


Static stretching with WBV increases DFROM in participants with CAI more effectively than static stretching alone.",2020,"The SV group demonstrated increased DFROM from baseline for both time points and a large effect size with 95% CI that did not cross zero from post tx-1 to post tx-2.
","['participants with CAI', 'individuals with chronic ankle instability', 'Thirty-nine participants with CAI (history of ankle sprain, a feeling of ""giving way"" during activity, and a qualifying Foot and Ankle Ability Measure Ankle score', 'individuals with chronic ankle instability (CAI']","['static stretch (SS), and static stretch with vibration (SV', 'static stretching', 'static stretching alone']","['DFROM', 'dorsiflexion ROM (DFROM', 'DFROM was assessed in a straight and bent-leg position']","[{'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0231748', 'cui_str': 'Giving-way'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}]","[{'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}]",39.0,0.0500288,"The SV group demonstrated increased DFROM from baseline for both time points and a large effect size with 95% CI that did not cross zero from post tx-1 to post tx-2.
","[{'ForeName': 'Feland', 'Initials': 'F', 'LastName': 'Jb', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: brent_feland@byu.edu.'}, {'ForeName': 'Thalman', 'Initials': 'T', 'LastName': 'Lesley', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: lesleyabigail@gmail.com.'}, {'ForeName': 'Hunter', 'Initials': 'H', 'LastName': 'I', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: iain_hunter@byu.edu.'}, {'ForeName': 'Cochrane', 'Initials': 'C', 'LastName': 'Dj', 'Affiliation': 'School of Sport, Exercise & Nutrition, Massey University, New Zealand. Electronic address: D.Cochrane@massey.ac.nz.'}, {'ForeName': 'Hopkins', 'Initials': 'H', 'LastName': 'Jt', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: tyhopkins@byu.edu.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.04.001']
178,32329747,The Scleroderma Patient-Centered Intervention Network Self-Management Program: Protocol for a Randomized Feasibility Trial.,"BACKGROUND


Systemic sclerosis (SSc), or scleroderma, is a rare disease that often results in significant disruptions to activities of daily living and can negatively affect physical and psychological well-being. Because there is no known cure, SSc treatment focuses on reducing symptoms and disability and improving health-related quality of life (HRQoL). Self-management programs are known to increase self-efficacy for disease management in many chronic diseases. The Scleroderma Patient-centered Intervention Network (SPIN) developed a Web-based self-management program (SPIN self-management; SPIN-SELF) to increase self-efficacy for disease management and to improve HRQoL for patients with SSc.
OBJECTIVE


The proposed study aims to assess the feasibility of conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF program by evaluating the trial implementation processes, required resources and management, scientific aspects, and participant acceptability and usage of the SPIN-SELF program.
METHODS


The SPIN-SELF feasibility trial will be conducted via the SPIN Cohort. The SPIN Cohort was developed as a framework for embedded pragmatic trials using the cohort multiple RCT design. In total, 40 English-speaking SPIN Cohort participants with low disease management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale score ≤7), who have indicated interest in using a Web-based self-management program, will be randomized with a 3:2 ratio into the SPIN-SELF program or usual care for 3 months. Feasibility outcomes include trial implementation processes, required resources and management, scientific aspects, and patient acceptability and usage of the SPIN-SELF program.
RESULTS


Enrollment of the 40 participants occurred between July 5, 2019, and July 27, 2019. By November 25, 2019, data collection of trial outcomes was completed. Data analysis is underway, and results are expected to be published in 2020.
CONCLUSIONS


The SPIN-SELF program is a self-help tool that may improve disease-management self-efficacy and improve HRQoL in patients with SSc. The SPIN-SELF feasibility trial will ensure that trial methodology is robust, feasible, and consistent with trial participant expectations. The results will guide adjustments that need to be implemented before undertaking a full-scale RCT of the SPIN-SELF program.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/16799.",2020,The SPIN-SELF program is a self-help tool that may improve disease-management self-efficacy and improve HRQoL in patients with SSc.,"['patients with SSc', '40 English-speaking SPIN Cohort participants with low disease management self-efficacy', 'Enrollment of the 40 participants occurred between July 5, 2019, and July 27, 2019']",['SPIN-SELF program'],"['symptoms and disability and improving health-related quality of life (HRQoL', 'resources and management, scientific aspects, and patient acceptability and usage of the SPIN-SELF program']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]","[{'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",40.0,0.0758917,The SPIN-SELF program is a self-help tool that may improve disease-management self-efficacy and improve HRQoL in patients with SSc.,"[{'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Carrier', 'Affiliation': 'Lady Davis Institute of the Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Kwakkenbos', 'Affiliation': 'Behavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, Netherlands.'}, {'ForeName': 'Warren R', 'Initials': 'WR', 'LastName': 'Nielson', 'Affiliation': ""St Joseph's Health Care, London, ON, Canada.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Fedoruk', 'Affiliation': 'Lady Davis Institute of the Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Nielsen', 'Affiliation': 'Scleroderma Society of Ontario, Hamilton, ON, Canada.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Milette', 'Affiliation': 'Lady Davis Institute of the Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Pope', 'Affiliation': 'University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Frech', 'Affiliation': 'University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Gholizadeh', 'Affiliation': 'California School of Professional Psychology/Alliant, Los Angeles, CA, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hummers', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Sindhu R', 'Initials': 'SR', 'LastName': 'Johnson', 'Affiliation': 'Toronto Scleroderma Program, Mount Sinai Hospital & Toronto Western Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Piotrowski', 'Affiliation': 'Private practice - Nutrition, Hamilton, ON, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Jewett', 'Affiliation': 'Lady Davis Institute of the Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gordon', 'Affiliation': 'Hospital for Special Surgery, New York, NY, United States.'}, {'ForeName': 'Lorinda', 'Initials': 'L', 'LastName': 'Chung', 'Affiliation': 'Departments of Pediatrics, Biomedical Data Science, Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, United States.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Bilsker', 'Affiliation': 'Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Turner', 'Affiliation': 'Lady Davis Institute of the Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Cumin', 'Affiliation': 'Lady Davis Institute of the Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Joep', 'Initials': 'J', 'LastName': 'Welling', 'Affiliation': 'NVLE Dutch patient organization for systemic autoimmune diseases, Utrecht, Netherlands.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Fortune', 'Affiliation': 'Scleroderma Society of Ontario, Hamilton, ON, Canada.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Leite', 'Affiliation': 'University of Minho, Braga, Portugal.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gottesman', 'Affiliation': 'Scleroderma Foundation, Los Angeles, CA, United States.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Sauve', 'Affiliation': 'Scleroderma Society of Ontario, Hamilton, ON, Canada.'}, {'ForeName': 'Tatiana S', 'Initials': 'TS', 'LastName': 'Rodríguez-Reyna', 'Affiliation': 'Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hudson', 'Affiliation': 'Lady Davis Institute of the Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Larche', 'Affiliation': 'McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Ward', 'Initials': 'W', 'LastName': 'van Breda', 'Affiliation': 'Faculty of Behavioural and Movement Sciences, Vrije University, Amsterdam, Netherlands.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Suarez-Almazor', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Bartlett', 'Affiliation': 'Department of Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Vanessa L', 'Initials': 'VL', 'LastName': 'Malcarne', 'Affiliation': 'San Diego State University, San Diego, CA, United States.'}, {'ForeName': 'Maureen D', 'Initials': 'MD', 'LastName': 'Mayes', 'Affiliation': 'University of Texas McGovern School of Medicine, Houston, TX, United States.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boutron', 'Affiliation': 'Université Paris Descartes, Paris, France.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Mouthon', 'Affiliation': 'Université Paris Descartes, Paris, France.'}, {'ForeName': 'Fredrick', 'Initials': 'F', 'LastName': 'Wigley', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Thombs', 'Affiliation': 'Lady Davis Institute of the Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'See Acknowledgments, .'}]",JMIR research protocols,['10.2196/16799']
179,32379660,A sleep hygiene and yoga intervention conducted in affordable housing communities: Pilot study results and lessons for a future trial.,"BACKGROUND


and purpose: Inadequate sleep is highly prevalent among socioeconomically disadvantaged and racial/ethnic minority communities and is often related to maladaptive sleep behaviors and stress. There is scant research investigating the delivery of these interventions in underserved communities. The purpose of this study was to develop and test the feasibility and acceptability of a sleep education and yoga intervention for socioeconomically disadvantaged and racial/ethnic diverse adults.
MATERIALS AND METHODS


We present quantitative and qualitative data from a single-arm sleep education and yoga pilot study (n = 17) conducted in two affordable housing communities, and the multi-modal process we employed to refine the intervention for a future trial.
RESULTS


Participants were age 43.6 years on average (±19.3 years) and 88.2% were female. Nearly 56% identified as non-Hispanic Black and 19% as Hispanic/Latino. Results showed significant pre/post-intervention improvements in sleep duration (5.4 ± 1.2 h/night vs 6.9 ± 1.7 h/night; p < 0.01), sleep-related impairment (-8.15; p < 0.01), sleep disturbance (-5.95; p < 0.01), and sleep hygiene behaviors (-5.50; p < 0.01).
CONCLUSION


This study indicates intervention acceptability and improvements in sleep and sleep hygiene. Future randomized controlled trials are needed to assess efficacy.",2020,Results showed significant pre/post-intervention improvements in sleep duration (5.4 ± 1.2 h/night vs 6.9 ± 1.7 h/night; p < 0.01),"['Participants were age 43.6 years on average (±19.3 years) and 88.2% were female', 'underserved communities', 'socioeconomically disadvantaged and racial/ethnic diverse adults', 'We present quantitative and qualitative data from a single-arm sleep education and yoga pilot study (n\xa0=\xa017']",['sleep education and yoga intervention'],"[' sleep-related impairment ', 'sleep duration', 'sleep disturbance', 'sleep and sleep hygiene', 'sleep hygiene behaviors']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0607289,Results showed significant pre/post-intervention improvements in sleep duration (5.4 ± 1.2 h/night vs 6.9 ± 1.7 h/night; p < 0.01),"[{'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Spadola', 'Affiliation': 'Sandler School of Social Work, Florida Atlantic University, Boca Raton, FL, USA. Electronic address: cspadola@fau.edu.'}, {'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Rottapel', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Zhou', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA, USA; Division of Sleep Medicine Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Jarvis T', 'Initials': 'JT', 'LastName': 'Chen', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Department of Social and Behavioral Sciences, Boston, MA, USA.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Guo', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Sat Bir S', 'Initials': 'SBS', 'LastName': 'Khalsa', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA, USA; Division of Sleep Medicine Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Redline', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA, USA; Division of Sleep Medicine Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Bertisch', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA, USA; Division of Sleep Medicine Harvard Medical School, Boston, MA, USA.""}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101121']
180,32380988,"The effect of 50% oxygen on PtCO 2  in patients with stable COPD, bronchiectasis, and neuromuscular disease or kyphoscoliosis: randomised cross-over trials.","BACKGROUND


High-concentration oxygen therapy causes increased arterial partial pressure of carbon dioxide (PaCO 2 ) in patients with COPD, asthma, pneumonia, obesity and acute lung injury. The objective of these studies was to investigate whether this physiological response to oxygen therapy occurs in stable patients with neuromuscular disease or kyphoscoliosis, and bronchiectasis.
METHODS


Three randomised cross-over trials recruited stable patients with neuromuscular disease or kyphoscoliosis (n = 20), bronchiectasis (n = 24), and COPD (n = 24). Participants were randomised to receive 50% oxygen and 21% oxygen (air), each for 30 min, in randomly assigned order. The primary outcome was transcutaneous partial pressure of carbon dioxide (PtCO 2 ) at 30 min. The primary analysis was a mixed linear model.
RESULTS


Sixty six of the 68 participants had baseline PtCO 2  values < 45 mmHg. The intervention baseline adjusted PtCO 2  difference (95% CI) between oxygen and room air after 30 min was 0.2 mmHg (- 0.4 to 0.9), P = 0.40; 0.5 mmHg (- 0.2 to 1.2), P = 0.18; and 1.3 mmHg (0.7 to 1.8), P < 0.001, in the neuromuscular/kyphoscoliosis, bronchiectasis and COPD participants respectively.
CONCLUSIONS


The small increase in PtCO 2  in the stable COPD patients with high-concentration oxygen therapy contrasts with the marked increases in PaCO 2  seen in the setting of acute exacerbations of COPD. This suggests that the model of studying the effects of high-concentration oxygen therapy in patients with stable respiratory disease is not generalisable to the use of oxygen therapy in the acute clinical setting. Appropriate studies of high-concentration compared to titrated oxygen in acute clinical settings are needed to determine if there is a risk of oxygen-induced hypercapnia in patients with neuromuscular disease, kyphoscoliosis or bronchiectasis.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12615000970549 Registered 16/9/15, ACTRN12615000971538 Registered 16/9/15 and ACTRN12615001056583 Registered 7/10/15.",2020,"The intervention baseline adjusted PtCO 2  difference (95% CI) between oxygen and room air after 30 min was 0.2 mmHg (- 0.4 to 0.9), P = 0.40; 0.5 mmHg (- 0.2 to 1.2), P = 0.18; and 1.3 mmHg (0.7 to 1.8), P < 0.001, in the neuromuscular/kyphoscoliosis, bronchiectasis and COPD participants respectively.
","['Sixty six of the 68 participants had baseline PtCO 2  values <\u200945\u2009mmHg', 'Three randomised cross-over trials recruited stable patients with neuromuscular disease or kyphoscoliosis (n\u2009=\u200920), bronchiectasis (n\u2009=\u200924), and COPD (n\u2009=\u200924', 'patients with COPD, asthma, pneumonia, obesity and acute lung injury', 'patients with stable respiratory disease', 'patients with neuromuscular disease, kyphoscoliosis or bronchiectasis', 'patients with stable COPD, bronchiectasis, and neuromuscular disease or kyphoscoliosis', 'stable patients with neuromuscular disease or kyphoscoliosis, and bronchiectasis']","['50% oxygen and 21% oxygen (air', 'high-concentration oxygen therapy', 'High-concentration oxygen therapy']","['transcutaneous partial pressure of carbon dioxide (PtCO 2 ', 'arterial partial pressure of carbon dioxide (PaCO 2 ']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027868', 'cui_str': 'Myoneural disorder'}, {'cui': 'C0345392', 'cui_str': 'Congenital kyphoscoliosis'}, {'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0242488', 'cui_str': 'Acute lung injury'}, {'cui': 'C0035204', 'cui_str': 'Disorder of respiratory system'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1278440', 'cui_str': 'High concentration oxygen therapy'}]","[{'cui': 'C0040653', 'cui_str': 'Measurement of transcutaneous partial pressure of carbon dioxide'}, {'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}]",,0.472731,"The intervention baseline adjusted PtCO 2  difference (95% CI) between oxygen and room air after 30 min was 0.2 mmHg (- 0.4 to 0.9), P = 0.40; 0.5 mmHg (- 0.2 to 1.2), P = 0.18; and 1.3 mmHg (0.7 to 1.8), P < 0.001, in the neuromuscular/kyphoscoliosis, bronchiectasis and COPD participants respectively.
","[{'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Pilcher', 'Affiliation': 'Medical Research Institute of New Zealand, Private Bag 7902, Wellington, 6242, New Zealand. Janine.pilcher@mrinz.ac.nz.'}, {'ForeName': 'Darmiga', 'Initials': 'D', 'LastName': 'Thayabaran', 'Affiliation': 'Medical Research Institute of New Zealand, Private Bag 7902, Wellington, 6242, New Zealand.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ebmeier', 'Affiliation': 'Medical Research Institute of New Zealand, Private Bag 7902, Wellington, 6242, New Zealand.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'Medical Research Institute of New Zealand, Private Bag 7902, Wellington, 6242, New Zealand.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Back', 'Affiliation': 'Capital & Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Hamish', 'Initials': 'H', 'LastName': 'Collie', 'Affiliation': 'Capital & Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Richards', 'Affiliation': 'Medical Research Institute of New Zealand, Private Bag 7902, Wellington, 6242, New Zealand.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Bibby', 'Affiliation': 'Medical Research Institute of New Zealand, Private Bag 7902, Wellington, 6242, New Zealand.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Semprini', 'Affiliation': 'Medical Research Institute of New Zealand, Private Bag 7902, Wellington, 6242, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weatherall', 'Affiliation': 'University of Otago Wellington, Wellington, New Zealand.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Private Bag 7902, Wellington, 6242, New Zealand.'}]",BMC pulmonary medicine,['10.1186/s12890-020-1132-z']
181,32380994,Effect of hip abductor strengthening exercises in knee osteoarthritis: a randomized controlled trial.,"BACKGROUND


Osteoarthritis knee (OA) for patients whom had varus malalignment had higher peak adductor moment. Hip abductor strength played an important role in the decreasement of knee adduction moment. This study aimed to evaluate the effect of hip abductor exercises for patients who had medial compartment knees OA.
METHODS


Patients who had medial compartmental OA knee were randomized into two groups. The first group performed hip abductor strengthening exercises, combined with quadriceps strengthening exercises; whereas, the second group performed standalone quadriceps strengthening exercises. Self-reported Knee Injury and Osteoarthritis Outcome Scores (KOOS) were collected by patients on follow-up visits.
RESULTS


Eighty-six patients completed the trial. All KOOS subscales were significantly improved in both groups after 10 weeks of treatment. However, there was no significant difference in the scores between either group at 2-10 weeks after treatment. Nevertheless, the effects of exercise for pain, symptoms, function in daily living and knee-related quality of life were found to have faster improvement within the hip abduction exercise group compared to the control group (2 weeks faster; pain, function in daily living and knee-related quality of life, 4 weeks faster; symptoms.) CONCLUSION: Since, adding quadriceps exercises could expedite improvement of less pain, symptoms, activity in daily living and quality of life faster than quadriceps exercises solely for a 2-4 weeks period. However, the effect size was small and there were no differences after this; hence, consideration of adding hip abductor exercises in the treatment protocol should be based on the patients and doctors appraisal.
TRIAL REGISTRATION


TCTR, TCTR20180517005. Registered 17 May 2018.",2020,"Nevertheless, the effects of exercise for pain, symptoms, function in daily living and knee-related quality of life were found to have faster improvement within the hip abduction exercise group compared to the control group (2 weeks faster; pain, function in daily living and knee-related quality of life, 4 weeks faster; symptoms.)","['knee osteoarthritis', 'Patients who had medial compartmental OA knee', 'Eighty-six patients completed the trial', 'patients who had medial compartment knees OA']","['hip abductor exercises', 'standalone quadriceps strengthening exercises', 'hip abductor strengthening exercises', 'hip abduction exercise', 'hip abductor strengthening exercises, combined with quadriceps strengthening exercises']","['pain, function in daily living and knee-related quality of life, 4\u2009weeks faster; symptoms', 'pain, symptoms, function in daily living and knee-related quality of life', 'Self-reported Knee Injury and Osteoarthritis Outcome Scores (KOOS', 'All KOOS subscales', 'pain, symptoms, activity in daily living and quality of life faster']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0447798', 'cui_str': 'Compartment of knee'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.0896008,"Nevertheless, the effects of exercise for pain, symptoms, function in daily living and knee-related quality of life were found to have faster improvement within the hip abduction exercise group compared to the control group (2 weeks faster; pain, function in daily living and knee-related quality of life, 4 weeks faster; symptoms.)","[{'ForeName': 'Varah', 'Initials': 'V', 'LastName': 'Yuenyongviwat', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand. varahortho@gmail.com.'}, {'ForeName': 'Siwakorn', 'Initials': 'S', 'LastName': 'Duangmanee', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand.'}, {'ForeName': 'Khanin', 'Initials': 'K', 'LastName': 'Iamthanaporn', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand.'}, {'ForeName': 'Pakjai', 'Initials': 'P', 'LastName': 'Tuntarattanapong', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand.'}, {'ForeName': 'Theerawit', 'Initials': 'T', 'LastName': 'Hongnaparak', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03316-z']
182,32381013,Assessing the Veterans Health Administration's response to intimate partner violence among women: protocol for a randomized hybrid type 2 implementation-effectiveness trial.,"BACKGROUND


Intimate partner violence (IPV) against women in the United States (US) remains a complex public health crisis. Women who experience IPV are among the most vulnerable patients seen in primary care. Screening increases the detection of IPV and, when paired with appropriate response interventions, can mitigate the health effects of IPV. The Department of Veterans Affairs (VA) has encouraged evidence-based IPV screening programs since 2014, yet adoption is modest and questions remain regarding the optimal ways to implement these practices, which are not yet available within the majority of VA primary care clinics.
METHODS/DESIGN


This paper describes the planned evaluation of VA's nationwide implementation of IPV screening programs in primary care clinics through a randomized implementation-effectiveness hybrid type 2 trial. With the support of our VA operational partners, we propose a stepped wedge design to compare the impact of two implementation strategies of differing intensities (toolkit + implementation as usual vs. toolkit + implementation facilitation) and investigate the clinical effectiveness of IPV screening programs. Using balanced randomization, 16-20 VA Medical Centers will be assigned to receive implementation facilitation in one of three waves, with implementation support lasting 6 months. Implementation facilitation in this effort consists of the coordinated efforts of the two types of facilitators, external and internal. Implementation facilitation is compared to dissemination of a toolkit plus implementation as usual. We propose a mixed methods approach to collect quantitative (clinical records data) and qualitative (key informant interviews) implementation outcomes, as well as quantitative (clinical records data) clinical effectiveness outcomes. We will supplement these data collection methods with provider surveys to assess discrete implementation strategies used before, during, and following implementation facilitation. The integrated-Promoting Action on Research Implementation in Health Services (i-PARIHS) framework will guide the qualitative data collection and analysis. Summative data will be analyzed using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework.
DISCUSSION


This research will advance national VHA efforts by identifying the practices and strategies useful for enhancing the implementation of IPV screening programs, thereby ultimately improving services for and health of women seen in primary care.
TRIAL REGISTRATION


NCT04106193. Registered on 23 September 2019.",2020,"This research will advance national VHA efforts by identifying the practices and strategies useful for enhancing the implementation of IPV screening programs, thereby ultimately improving services for and health of women seen in primary care.
","['Health Services', 'primary care clinics', 'Intimate partner violence (IPV) against women in the United States (US) remains a complex public health crisis', ""Veterans Health Administration's response to intimate partner violence among women""]",['IPV screening programs'],['detection of IPV'],"[{'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0178672', 'cui_str': 'Health administration'}]","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",,0.0919335,"This research will advance national VHA efforts by identifying the practices and strategies useful for enhancing the implementation of IPV screening programs, thereby ultimately improving services for and health of women seen in primary care.
","[{'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Iverson', 'Affiliation': ""Women's Health Sciences Division, National Center for PTSD, VA Boston Healthcare System, 150\u2009South Huntington Ave (116B-3), Boston, MA, 02130, USA. Katherine.Iverson@va.gov.""}, {'ForeName': 'Melissa E', 'Initials': 'ME', 'LastName': 'Dichter', 'Affiliation': 'VA Center for Health Equity Research and Promotion (CHERP), Corporal Michael J. Crescenz VA Medical Center, 3900 Woodland Ave, Philadelphia, 19104, PA, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Stolzmann', 'Affiliation': 'Center for Healthcare Organization and Implementation Research (CHOIR), VA Boston Healthcare System, 150\u2009S. Huntington Ave (152\u2009M), Boston, MA, 02130, USA.'}, {'ForeName': 'Omonyêlé L', 'Initials': 'OL', 'LastName': 'Adjognon', 'Affiliation': 'Center for Healthcare Organization and Implementation Research (CHOIR), VA Boston Healthcare System, 150\u2009S. Huntington Ave (152\u2009M), Boston, MA, 02130, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Lew', 'Affiliation': 'Massachusetts Veterans Epidemiology Research and Information Center, VA Boston Healthcare System, 150\u2009S. Huntington Ave (152\u2009M), Boston, MA, 02130, USA.'}, {'ForeName': 'LeAnn E', 'Initials': 'LE', 'LastName': 'Bruce', 'Affiliation': 'Intimate Partner Violence Assistance Program, Care Management and Social Work, Department of Veterans Affairs, 810 Vermont Avenue, Washington, DC, 20420, USA.'}, {'ForeName': 'Megan R', 'Initials': 'MR', 'LastName': 'Gerber', 'Affiliation': ""Women's Health Center, VA Boston Healthcare System, 150\u2009S. Huntington Ave, Boston, MA, 02130, USA.""}, {'ForeName': 'Galina A', 'Initials': 'GA', 'LastName': 'Portnoy', 'Affiliation': 'Pain, Research, Informatics, Medical comorbidities, and Education (PRIME) Center, VA Conneticut Healthcare System, 950 Campbell Avenue, West Haven, CT, 06516, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Miller', 'Affiliation': 'Center for Healthcare Organization and Implementation Research (CHOIR), VA Boston Healthcare System, 150\u2009S. Huntington Ave (152\u2009M), Boston, MA, 02130, USA.'}]",Implementation science : IS,['10.1186/s13012-020-0969-0']
183,32385730,CARGEL Bioscaffold improves cartilage repair tissue after bone marrow stimulation in a minipig model.,"PURPOSE


To gain knowledge of the repair tissue in critically sized cartilage defects using bone marrow stimulation combined with CARGEL Bioscaffold (CB) compared with bone marrow stimulation (BMS) alone in a validated animal model.
METHODS


Six adult Göttingen minipigs received two chondral defects in each knee. The knees were randomized to either BMS combined with CB or BMS alone. The animals were euthanized after 6 months. Follow-up consisted of histomorphometry, immunohistochemistry, semiquantitative scoring of the repair tissue (ICRS II), and μCT of the trabecular bone beneath the defect.
RESULTS


There was significantly more fibrocartilage (80% vs 64%, p = 0.04) and a trend towards less fibrous tissue (15% vs 30%, p = 0.05) in the defects treated with CB. Hyaline cartilage was only seen in one defect treated with CB and none treated with BMS alone. For histological semiquantitative score (ICRS II), defects treated with CB scored lower on subchondral bone (69 vs. 44, p = 0.04). No significant differences were seen on the other parameters of the ICRS II. Immunohistochemistry revealed a trend towards more positive staining for collagen type II in the CB group (p = 0.08). μCT demonstrated thicker trabeculae (p = 0.029) and a higher bone material density (p = 0.028) in defects treated with CB.
CONCLUSION


Treatment of cartilage injuries with CARGEL Bioscaffold seems to lead to an improved repair tissue and a more pronounced subchondral bone response compared with bone marrow stimulation alone. However, the CARGEL Bioscaffold treatment did not lead to formation of hyaline cartilage.",2020,Immunohistochemistry revealed a trend towards more positive staining for collagen type II in the CB group (p = 0.08).,['Six adult Göttingen minipigs received two chondral defects in each knee'],"['CARGEL Bioscaffold', 'BMS', 'BMS combined with CB or BMS alone', 'bone marrow stimulation combined with CARGEL Bioscaffold (CB', 'bone marrow stimulation (BMS', 'μCT']","['subchondral bone response', 'histological semiquantitative score (ICRS II), defects treated with CB scored lower on subchondral bone', 'fibrous tissue', 'cartilage repair tissue', 'positive staining for collagen type', 'bone material density', 'fibrocartilage', 'Hyaline cartilage']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039011', 'cui_str': 'Miniature Swine'}, {'cui': 'C0410334', 'cui_str': 'Defect of articular cartilage'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]","[{'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0225331', 'cui_str': 'Fibrous tissue'}, {'cui': 'C1112785', 'cui_str': 'Cartilage repair'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0684077', 'cui_str': 'Fibrocartilage'}, {'cui': 'C0225362', 'cui_str': 'Hyaline cartilage'}]",6.0,0.0454569,Immunohistochemistry revealed a trend towards more positive staining for collagen type II in the CB group (p = 0.08).,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hede', 'Affiliation': 'Orthopedic Research Laboratory, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Section J, Level 1, 8200, Aarhus N, Denmark. kch@clin.au.dk.'}, {'ForeName': 'B B', 'Initials': 'BB', 'LastName': 'Christensen', 'Affiliation': 'Orthopedic Research Laboratory, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Section J, Level 1, 8200, Aarhus N, Denmark.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Olesen', 'Affiliation': 'Orthopedic Research Laboratory, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Section J, Level 1, 8200, Aarhus N, Denmark.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Thomsen', 'Affiliation': 'Department of Biomedicine, Aarhus University, Wilhelm Meyers Allé 3, 8000, Aarhus C, Denmark.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Foldager', 'Affiliation': 'Orthopedic Research Laboratory, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Section J, Level 1, 8200, Aarhus N, Denmark.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Lind', 'Affiliation': 'Orthopedic Research Laboratory, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Section J, Level 1, 8200, Aarhus N, Denmark.'}]",Journal of experimental orthopaedics,['10.1186/s40634-020-00245-7']
184,32390925,Selection of the Better Dual-Timed Up and Go Cognitive Task to Be Used in Patients With Stroke Characterized by Subtraction Operation Difficulties.,"Background:  The Timed Up and Go Test (TUG) with serial subtraction is commonly used to assess cognitive-dual task performance during walking for fall prediction. Some stroke patients cannot perform number subtraction and it is unclear which cognitive task can be used to substitute for the subtraction task in the TUG test. The aim of this study was to determine the type of cognitive task that produced the highest decrease on both motor and cognitive performances during TUG-dual in stroke patients.  Methods:  A total of 23 persons with stroke but capable of completing subtraction (ST) and 19 persons with subtraction operation difficulties (SOD) participated. Both groups have a similar age range (ST: 59.3 ± 10.4 years and SOD: 62.0 ± 6.8 years) and stroke onset duration (ST: 44.13 ± 62.29 months and SOD: 42.34 ± 39.69 months). The participants performed TUG without a cognitive task (TUG-single) followed by a cognitive task when seated (cognitive-single). In addition, TUG with a cognitive task (TUG-dual) was performed, with the activity randomly selected from four cognitive tasks, including alternate reciting, auditory working memory, clock task, and phonologic fluency. The main outcome variables-TUG duration measured by OPAL accelerometer and cognitive-dual task effect (DTE)-were analyzed using repeated-measures analyses of variance (ANOVA).  Results:  The number of correct responses when seated were significantly lower in the SOD as compared to the ST ( p  < 0.05) during all cognitive tasks, except the phonologic fluency. During TUG-cognitive, TUG duration in the ST was significantly longer for all cognitive tasks compared with TUG-single ( p  < 0.0001), whereas TUG duration in the SOD was significantly increased only during the phonologic fluency task ( p  < 0.01). In the ST, there was a significant difference in cognitive DTE between the subtraction and the phonologic fluency tasks ( p  < 0.01). The highest cognitive cost was found in the subtraction task, whereas the highest cognitive benefit was shown in the phonologic fluency task. No significant cognitive DTE was found among the cognitive tasks in the SOD.  Conclusion:  For stroke persons with SOD, phonologic fluency is suitable to be used in the TUG-cognitive assessment. In contrast, subtraction (by 3s) is recommended for the assessment of TUG-cognitive in stroke persons who can perform subtraction.",2020,"During TUG-cognitive, TUG duration in the ST was significantly longer for all cognitive tasks compared with TUG-single ( p  < 0.0001), whereas TUG duration in the SOD was significantly increased only during the phonologic fluency task ( p  < 0.01).","['stroke persons with SOD, phonologic fluency', 'Both groups have a similar age range (ST: 59.3 ± 10.4 years and SOD: 62.0 ± 6.8 years) and stroke onset duration (ST: 44.13 ± 62.29 months and SOD: 42.34 ± 39.69 months', 'stroke patients', '23 persons with stroke but capable of completing subtraction (ST) and 19 persons with subtraction operation difficulties (SOD) participated', 'Patients With Stroke Characterized by Subtraction Operation Difficulties']","['TUG with a cognitive task (TUG-dual', 'TUG without a cognitive task (TUG-single) followed by a cognitive task when seated (cognitive-single']","['motor and cognitive performances', 'highest cognitive cost', 'TUG duration measured by OPAL accelerometer and cognitive-dual task effect (DTE)-were analyzed using repeated-measures analyses of variance (ANOVA', 'cognitive DTE', 'phonologic fluency', 'cognitive-dual task performance', 'phonologic fluency tasks', 'TUG duration in the SOD', 'number of correct responses']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0084990', 'cui_str': 'VPDA protocol'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0002780', 'cui_str': 'Analysis, Variance'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",23.0,0.0144992,"During TUG-cognitive, TUG duration in the ST was significantly longer for all cognitive tasks compared with TUG-single ( p  < 0.0001), whereas TUG duration in the SOD was significantly increased only during the phonologic fluency task ( p  < 0.01).","[{'ForeName': 'Ampha', 'Initials': 'A', 'LastName': 'Pumpho', 'Affiliation': 'Faculty of Physical Therapy, Srinakharinwirot University, Nakhonnayok, Thailand.'}, {'ForeName': 'Nithinun', 'Initials': 'N', 'LastName': 'Chaikeeree', 'Affiliation': 'Faculty of Physical Therapy, Srinakharinwirot University, Nakhonnayok, Thailand.'}, {'ForeName': 'Vitoon', 'Initials': 'V', 'LastName': 'Saengsirisuwan', 'Affiliation': 'Department of Physiology, Faculty of Science, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Rumpa', 'Initials': 'R', 'LastName': 'Boonsinsukh', 'Affiliation': 'Faculty of Physical Therapy, Srinakharinwirot University, Nakhonnayok, Thailand.'}]",Frontiers in neurology,['10.3389/fneur.2020.00262']
185,32391068,Effects of six month personalized endurance training on work ability in middle-aged sedentary women: a secondary analysis of a randomized controlled trial.,"Background


To test the effects of guided endurance training on work ability in middle-aged female hospital workers of various occupations.
Methods


We randomized 265 healthy, sedentary, middle-aged women (45-65 years) to an endurance training group (EG 210 min/week) or a wait-list control group (CG). At baseline and at 6-month follow-up, we assessed work ability (Work Ability Index [WAI]), physical activity (Freiburger activity questionnaire) and peak oxygen uptake (VO 2peak ) by cardiopulmonary exercise testing. To examine the influence of baseline work ability, participants were divided into poor-moderate (WAI 1, 7-36 points,  n  = 83), good (WAI 2, 37-43 points,  n  = 136) and excellent (WAI 3, 44-49 points,  n  = 46) WAI subgroups.
Results


Cardiorespiratory fitness improved significantly after 6 months in the EG but not in the CG. The WAI total score increased significantly in the EG (38.3 ± 5.0 to 39.8 ± 4.9 points) but not in the CG (39.4 ± 4.7 to 39.3 ± 4.9 points), with a significant difference between groups ( p  < 0.01). In the EG, only the poor-moderate subgroup (WAI 1, 33.0 ± 2.9 to 36.6 ± 4.8 points,  p  < 0.05) increased the WAI total score, with this increase being significantly higher compared to the good (WAI 2, 40.2 ± 2.1 to, 40.4 ± 3.7 points) and excellent (WAI 3, 45.6 ± 1.5 to 45.7 ± 1.8 points) subgroup.
Conclusions


A 6-month guided exercise training intervention significantly increases cardiorespiratory fitness with concomitant improvements in work ability in middle-aged previously sedentary hospital employees. Women with low baseline work ability seem to particularly benefit from the intervention, which implies that similar interventions may be particularly beneficial for this group of individuals.
Trial registration


German Clinical Trails Register Identifier: DRKS00005159. Registered 25 September 2013.",2020,"Conclusions


A 6-month guided exercise training intervention significantly increases cardiorespiratory fitness with concomitant improvements in work ability in middle-aged previously sedentary hospital employees.","['middle-aged sedentary women', 'middle-aged previously sedentary hospital employees', 'middle-aged female hospital workers of various occupations', '265 healthy, sedentary, middle-aged women (45-65\u2009years) to an']","['endurance training group (EG 210\u2009min/week) or a wait-list control group (CG', 'guided endurance training', 'guided exercise training intervention', 'personalized endurance training']","['work ability (Work Ability Index [WAI]), physical activity (Freiburger activity questionnaire) and peak oxygen uptake (VO 2peak ', 'cardiorespiratory fitness', 'WAI total score', 'Cardiorespiratory fitness']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",265.0,0.047855,"Conclusions


A 6-month guided exercise training intervention significantly increases cardiorespiratory fitness with concomitant improvements in work ability in middle-aged previously sedentary hospital employees.","[{'ForeName': 'Hedwig T', 'Initials': 'HT', 'LastName': 'Stenner', 'Affiliation': '1Institute of Sports Medicine, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Eigendorf', 'Affiliation': '1Institute of Sports Medicine, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'Kerling', 'Affiliation': '1Institute of Sports Medicine, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Momme', 'Initials': 'M', 'LastName': 'Kueck', 'Affiliation': '1Institute of Sports Medicine, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Hanke', 'Affiliation': '1Institute of Sports Medicine, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Boyen', 'Affiliation': '1Institute of Sports Medicine, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Anne-Katrin', 'Initials': 'AK', 'LastName': 'Nelius', 'Affiliation': '1Institute of Sports Medicine, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Melk', 'Affiliation': '2Department of Pediatric Kidney, Liver and Metabolic Diseases, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Boethig', 'Affiliation': '3Department of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bara', 'Affiliation': '3Department of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Hilfiker', 'Affiliation': '3Department of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Berliner', 'Affiliation': '4Department of Cardiology and Angiology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Bauersachs', 'Affiliation': '4Department of Cardiology and Angiology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Hilfiker-Kleiner', 'Affiliation': '4Department of Cardiology and Angiology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Eberhard', 'Affiliation': '5Department of Prosthetic Dentistry and Biomedical Material Sciences, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Meike', 'Initials': 'M', 'LastName': 'Stiesch', 'Affiliation': '5Department of Prosthetic Dentistry and Biomedical Material Sciences, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Cordula', 'Initials': 'C', 'LastName': 'Schippert', 'Affiliation': '6Department of Obstetrics and Gynecology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Haverich', 'Affiliation': '3Department of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Tegtbur', 'Affiliation': '1Institute of Sports Medicine, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Haufe', 'Affiliation': '1Institute of Sports Medicine, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}]","Journal of occupational medicine and toxicology (London, England)",['10.1186/s12995-020-00261-4']
186,32391109,Decreased biochemical progression in patients with castration-resistant prostate cancer using a novel mefenamic acid anti-inflammatory therapy: A randomized controlled trial.,"Prostate cancer (PCa) is the second most common non-dermatological cancer in men and is a growing public health problem. Castration-resistant disease (CRD) is the most advanced stage of the disease and is difficult to control. Patients with CRD may no longer accept conventional therapies as they are not in appropriate clinical conditions or they refuse to receive it. Given that inflammation is an essential component of CRD origin and progression, anti-inflammatory agents could be a therapeutic option with fenamates as one of the proposed choices. A prospective, randomized, double-blinded, 2-arm, parallel group, phase II-III clinical trial was performed involving 20 patients with CRD-PCa (with a prostate specific antigen level <100 ng/ml) that were undergoing androgen deprivation therapy (ADT) and did not accept any established treatment for that disease stage. In addition to ADT, 10 patients received placebo and 10 received mefenamic acid (500 mg orally every 12 h) for 6 months. The primary endpoint was the change in serum prostate-specific antigen (PSA) at 6 months. The PSA levels decreased significantly with mefenamic acid (an average 42% decrease), whereas there was an average 55% increase in the placebo group (P=0.024). In the patients treated with the placebo, 70% had biochemical disease progression (an increase of ≥25% in PSA levels), which did not occur in any of the patients treated with mefenamic acid (relative risk=0.12; 95% confidence interval, 0.01-0.85; P=0.033). There was a significant increase in quality of life (EQ-5D-5L score) and body mass index (BMI) with the experimental treatment. In conclusion, mefenamic acid administration decreased biochemical progression in patients with castration resistant PCa, improved their quality of life and increased their BMI. Future studies are required in order to strengthen the findings of the present clinical trial. Trial registration, Cuban Public Registry of Clinical Trials Database RPCEC00000248, August 2017.",2020,There was a significant increase in quality of life (EQ-5D-5L score) and body mass index (BMI) with the experimental treatment.,"['Patients with CRD', '20 patients with CRD-PCa (with a prostate specific antigen level <100 ng/ml) that were undergoing androgen deprivation therapy (ADT) and did not accept any established treatment for that disease stage', 'patients with castration resistant PCa', 'patients with castration-resistant prostate cancer']","['Castration-resistant disease (CRD', 'mefenamic acid anti-inflammatory therapy', 'mefenamic acid', 'placebo']","['biochemical progression', 'biochemical disease progression', 'quality of life (EQ-5D-5L score) and body mass index (BMI', 'PSA levels', 'change in serum prostate-specific antigen (PSA', 'quality of life and increased their BMI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0033575', 'cui_str': 'Disorder of prostate'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}]","[{'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0025152', 'cui_str': 'mefenamic acid'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0231254', 'cui_str': 'Increased body mass index'}]",20.0,0.285137,There was a significant increase in quality of life (EQ-5D-5L score) and body mass index (BMI) with the experimental treatment.,"[{'ForeName': 'José', 'Initials': 'J', 'LastName': 'Guzman-Esquivel', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, Mexico.'}, {'ForeName': 'Martha A', 'Initials': 'MA', 'LastName': 'Mendoza-Hernandez', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, Mexico.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Tiburcio-Jimenez', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, Mexico.'}, {'ForeName': 'Oscar N', 'Initials': 'ON', 'LastName': 'Avila-Zamora', 'Affiliation': 'Department of Research, Cancerology State Institute, Colima State Health Services, Colima 28085, Mexico.'}, {'ForeName': 'Josuel', 'Initials': 'J', 'LastName': 'Delgado-Enciso', 'Affiliation': 'Department of Research, Foundation for Cancer Ethics, Education and Research of The Cancerology State Institute, Colima 28085, Mexico.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'De-Leon-Zaragoza', 'Affiliation': 'Department of Research, General Hospital of Zone No. 1 IMSS, Villa de Alvarez, Colima 28983, Mexico.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Casarez-Price', 'Affiliation': 'Department of Research, General Hospital of Zone No. 1 IMSS, Villa de Alvarez, Colima 28983, Mexico.'}, {'ForeName': 'Iram P', 'Initials': 'IP', 'LastName': 'Rodriguez-Sanchez', 'Affiliation': 'Molecular and Structural Physiology Laboratory, School of Biological Sciences, Autonomous University of Nuevo León, Monterrey, Nuevo León 64460, Mexico.'}, {'ForeName': 'Margarita L', 'Initials': 'ML', 'LastName': 'Martinez-Fierro', 'Affiliation': 'Molecular Medicine Laboratory, Academic Unit of Human Medicine and Health Sciences, Autonomous University of Zacatecas, Zacatecas, Zacatecas 98160, Mexico.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Meza-Robles', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, Mexico.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Barocio-Acosta', 'Affiliation': 'Department of Research, Cancerology State Institute, Colima State Health Services, Colima 28085, Mexico.'}, {'ForeName': 'Luz M', 'Initials': 'LM', 'LastName': 'Baltazar-Rodriguez', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, Mexico.'}, {'ForeName': 'Sergio A', 'Initials': 'SA', 'LastName': 'Zaizar-Fregoso', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, Mexico.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Plata-Florenzano', 'Affiliation': 'Department of Research, General Hospital of Zone No. 1 IMSS, Villa de Alvarez, Colima 28983, Mexico.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Delgado-Enciso', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, Mexico.'}]",Oncology letters,['10.3892/ol.2020.11509']
187,32391134,Are physical therapy pain levels affected by surgical approach in total hip arthroplasty? A randomized controlled trial.,"The main objective of this study was to evaluate the difference in pain levels during postoperative physical therapy pathways in patients who underwent a cement less total hip replacement either through a muscle sparing direct anterior approach (DAA), or the classic trans-gluteal lateral approach (LA). One hundred and twelve (112) patients were randomized into two equal groups. Baseline values of myoglobin levels were acquired prior to surgery and repeated at 6 hours postoperatively as a biomarker for muscle damage. Pain levels during the first passive and consecutive 3 active physical therapy sessions were noted using a visual analogue-numeric scale (VAS). Pain levels were also acquired at 6 weeks, 3 months, 6 months and 1 year, following a 20-meter (65.6 feet) walking test. Postoperative myoglobin (ng/mL) levels were significantly higher (p< 0.05) in the LA group (335.05±83.54) then the DAA group (237.71±57.54). Pain levels were significantly lower (p<0.001) in the DAA group for both passive (2.5±1.45 vs. 4.28±2.19) and active physical therapy sessions and there was a positive correlation between postoperative myoglobin levels and pain levels until 6 postoperative weeks. There was no significant difference in demographics between the two groups except for gender distribution. The direct anterior approach's main advantage of being a minimally invasive muscle sparing technique is showing a better rehabilitation experience with lower pain levels during passive and active physical therapy when compared to the classic trans-gluteal lateral approach.",2020,Postoperative myoglobin (ng/mL) levels were significantly higher (p< 0.05) in the LA group (335.05±83.54) then the DAA group (237.71±57.54).,"['patients who underwent a cement less total hip replacement either through a', 'One hundred and twelve (112) patients']","['muscle sparing direct anterior approach (DAA), or the classic trans-gluteal lateral approach (LA']","['Baseline values of myoglobin levels', 'Postoperative myoglobin (ng/mL) levels', 'visual analogue-numeric scale (VAS', 'pain levels', 'Pain levels', 'postoperative myoglobin levels and pain levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0205514', 'cui_str': 'Lateral approach'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0202142', 'cui_str': 'Myoglobin measurement, urine'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",112.0,0.035969,Postoperative myoglobin (ng/mL) levels were significantly higher (p< 0.05) in the LA group (335.05±83.54) then the DAA group (237.71±57.54).,"[{'ForeName': 'Dan-Viorel', 'Initials': 'DV', 'LastName': 'Nistor', 'Affiliation': 'Department of Orthopedics, Traumatology and Pediatric Orthopedics, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Nicolae Ciprian', 'Initials': 'NC', 'LastName': 'Bota', 'Affiliation': 'Department of Orthopedics, Traumatology and Pediatric Orthopedics, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Sergiu', 'Initials': 'S', 'LastName': 'Caterev', 'Affiliation': 'Department of Orthopedics, Traumatology and Pediatric Orthopedics, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Todor', 'Affiliation': 'Department of Orthopedics, Traumatology and Pediatric Orthopedics, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}]",Orthopedic reviews,['10.4081/or.2020.8399']
188,32386720,"Raltegravir versus efavirenz in antiretroviral-naive pregnant women living with HIV (NICHD P1081): an open-label, randomised, controlled, phase 4 trial.","BACKGROUND


Although antiretroviral regimens containing integrase inhibitors rapidly suppress HIV viral load in non-pregnant adults, few published data from randomised controlled trials have compared the safety and efficacy of any integrase inhibitor to efavirenz when initiated during pregnancy. We compared safety and efficacy of antiretroviral therapy with either raltegravir or efavirenz in late pregnancy.
METHODS


An open-label, randomised controlled trial was done at 19 hospitals and clinics in Argentina, Brazil, South Africa, Tanzania, Thailand, and the USA. Antiretroviral-naive pregnant women (20-<37 weeks gestation) living with HIV were assigned to antiretroviral regimens containing either raltegravir (400 mg twice daily) or efavirenz (600 mg each night) plus lamivudine 150 mg and zidovudine 300 mg twice daily (or approved alternative backbone regimen), using a web-based, permuted-block randomisation stratified by gestational age and backbone regimen. The primary efficacy outcome was plasma HIV viral load below 200 copies per mL at (or near) delivery. The primary efficacy analysis included all women with a viral load measurement at (or near) delivery who had viral load of at least 200 copies per mL before treatment and no genotypic resistance to any study drugs; secondary analyses eliminated these exclusion criteria. The primary safety analyses included all women who received study drug, and their infants. This trial is registered with Clinicaltrials.gov, number NCT01618305.
FINDINGS


From Sep 5, 2013, to Dec 11, 2018, 408 women were enrolled (206 raltegravir, 202 efavirenz) and 394 delivered on-study (200 raltegravir, 194 efavirenz); 307 were included in the primary efficacy analysis (153 raltegravir, 154 efavirenz). 144 (94%) women in the raltegravir group and 129 (84%) in the efavirenz group met the primary efficacy outcome (absolute difference 10%, 95% CI 3-18; p=0·0015); the difference primarily occurred among women enrolling later in pregnancy (interaction p=0·040). Frequencies of severe or life-threatening adverse events were similar among mothers (30% in each group; 61 raltegravir, 59 efavirenz) and infants (25% in each group; 50 raltegravir, 48 efavirenz), with no treatment-related deaths.
INTERPRETATION


Our findings support major guidelines. The integrase inhibitor dolutegravir is currently a preferred regimen for the prevention of perinatal HIV transmission with raltegravir recommended as a preferred or alternative integrase inhibitor for pregnant women living with HIV.
FUNDING


Eunice Kennedy Shriver National Institute of Child Health and Human Development and National Institute of Allergy and Infectious Diseases.",2020,"Frequencies of severe or life-threatening adverse events were similar among mothers (30% in each group; 61 raltegravir, 59 efavirenz) and infants (25% in each group; 50 raltegravir, 48 efavirenz), with no treatment-related deaths.
","['non-pregnant adults', 'women with a viral load measurement at (or near) delivery who had viral load of at least 200 copies per mL before treatment and no genotypic resistance to any study drugs; secondary analyses eliminated these exclusion criteria', '19 hospitals and clinics in Argentina, Brazil, South Africa, Tanzania, Thailand, and the USA', 'Antiretroviral-naive pregnant women (20-<37 weeks gestation) living with HIV', 'antiretroviral-naive pregnant women living with HIV (NICHD P1081', 'From Sep 5, 2013, to Dec 11, 2018, 408 women were enrolled (206 raltegravir, 202 efavirenz) and 394 delivered on-study (200 raltegravir, 194 efavirenz); 307 were included in the primary efficacy analysis (153 raltegravir, 154 efavirenz', 'pregnant women living with HIV', '144']","['lamivudine 150 mg and zidovudine', 'raltegravir', 'raltegravir or efavirenz', 'efavirenz', 'Raltegravir versus efavirenz']","['Frequencies of severe or life-threatening adverse events', 'safety and efficacy', 'plasma HIV viral load below 200 copies per mL at (or near) delivery']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1261478', 'cui_str': 'Viral load'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1513896', 'cui_str': 'National Institute of Child Health and Human Development'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C4760627', 'cui_str': '144'}]","[{'cui': 'C0987069', 'cui_str': 'Lamivudine 150 MG'}, {'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",408.0,0.357245,"Frequencies of severe or life-threatening adverse events were similar among mothers (30% in each group; 61 raltegravir, 59 efavirenz) and infants (25% in each group; 50 raltegravir, 48 efavirenz), with no treatment-related deaths.
","[{'ForeName': 'Esaú C', 'Initials': 'EC', 'LastName': 'João', 'Affiliation': 'Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil. Electronic address: esaujoao@gmail.com.'}, {'ForeName': 'R Leavitt', 'Initials': 'RL', 'LastName': 'Morrison', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Shapiro', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Nahida', 'Initials': 'N', 'LastName': 'Chakhtoura', 'Affiliation': 'Maternal and Pediatric Infectious Diseases Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Maria Isabel S', 'Initials': 'MIS', 'LastName': 'Gouvèa', 'Affiliation': 'Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil; Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'de Lourdes B Teixeira', 'Affiliation': 'Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil; Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.'}, {'ForeName': 'Trevon L', 'Initials': 'TL', 'LastName': 'Fuller', 'Affiliation': 'Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil.'}, {'ForeName': 'Blandina T', 'Initials': 'BT', 'LastName': 'Mmbaga', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Ngocho', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Boniface N', 'Initials': 'BN', 'LastName': 'Njau', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Avy', 'Initials': 'A', 'LastName': 'Violari', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johanesburg, South Africa.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Mathiba', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johanesburg, South Africa.'}, {'ForeName': 'Zaynab', 'Initials': 'Z', 'LastName': 'Essack', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johanesburg, South Africa.'}, {'ForeName': 'Jose Henrique S', 'Initials': 'JHS', 'LastName': 'Pilotto', 'Affiliation': 'Hospital Geral de Nova Iguaçu, Nova Iguaçu, Brazil.'}, {'ForeName': 'Luis Felipe', 'Initials': 'LF', 'LastName': 'Moreira', 'Affiliation': 'Hospital Geral de Nova Iguaçu, Nova Iguaçu, Brazil.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Rolon', 'Affiliation': 'Fundacion Huesped, Buenos Aires, Argentina.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Cahn', 'Affiliation': 'Fundacion Huesped, Buenos Aires, Argentina.'}, {'ForeName': 'Sinart', 'Initials': 'S', 'LastName': 'Prommas', 'Affiliation': 'Bhumibol Adulyadej Hospital, Bangkok, Thailand.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Cressey', 'Affiliation': 'PHPT/IRD 174, Faculty of Associated Medical Sciences, Chiang Mai University and Chiangrai Prachanukroh Hospital, Chiang Mai, Thailand.'}, {'ForeName': 'Kulkanya', 'Initials': 'K', 'LastName': 'Chokephaibulkit', 'Affiliation': 'Bhumibol Adulyadej Hospital, Bangkok, Thailand.'}, {'ForeName': 'Peerawong', 'Initials': 'P', 'LastName': 'Werarak', 'Affiliation': 'Bhumibol Adulyadej Hospital, Bangkok, Thailand.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Laimon', 'Affiliation': 'Westat, Rockville, MD, USA.'}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Hennessy', 'Affiliation': 'Westat, Rockville, MD, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Frenkel', 'Affiliation': ""University of Washington and Seattle Children's Hospital, Seattle, WA, USA.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Anthony', 'Affiliation': 'University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Brookie M', 'Initials': 'BM', 'LastName': 'Best', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'George K', 'Initials': 'GK', 'LastName': 'Siberry', 'Affiliation': 'US Agency for International Development, Washington, DC, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mirochnick', 'Affiliation': 'Boston University School of Medicine, Boston, MA, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30038-2']
189,32387214,"Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis-an open labelled, randomized controlled trial.","AIMS & OBJECTIVES


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


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


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


SLIA was comparable to DLIA with respect to incidence of anastomotic leak, morbidity, mortality, and the length of hospitalization, and can be considered as a safe and feasible alternative, in elective and emergency settings.",2020,"SLIA was comparable to DLIA with respect to incidence of anastomotic leak, morbidity, mortality, and the length of hospitalisation, and can be considered as a safe and feasible alternative, in elective and emergency settings.","['Patients who fulfilled the inclusion criteria', 'department of surgery in a tertiary care centre between October 2016 and March 2018', '106 patients were randomised, 52 in SLIA and 54 in DLIA']","['single layered intestinal anastomosis', 'single layer intestinal anastomosis (SLIA', 'Double layer intestinal anastomosis (DLIA', 'SLIA and patients undergoing DLIA']","['anastomotic leak, other complications, mortality and LOH.\nCONCLUSION', 'mortality, morbidity, and length of hospitalisation (LOH', 'Baseline demographic and clinicopathological characteristics', 'anastomotic leak, morbidity, mortality, and the length of hospitalisation', 'anastomotic leak, morbidity, mortality and LOH']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",106.0,0.173847,"SLIA was comparable to DLIA with respect to incidence of anastomotic leak, morbidity, mortality, and the length of hospitalisation, and can be considered as a safe and feasible alternative, in elective and emergency settings.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Aniruthan', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'Amuda Ravichandar', 'Initials': 'AR', 'LastName': 'Pranavi', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'Gubbi Shamanna', 'Initials': 'GS', 'LastName': 'Sreenath', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Kate', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India. Electronic address: dr.sreenathgs@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.04.066']
190,32289353,Risk of contamination when planning psychological therapy trials can be assessed using a simple framework.,"OBJECTIVES


The objective of this study was to develop and pilot a standard framework that could be used to assess risk of contamination in psychological therapy trials, at the protocol development stage.
STUDY DESIGN AND SETTING


We developed and piloted a risk of contamination framework on a sample of 100 psychological therapy trial protocols registered on the International Standard Randomised Controlled Trial Number (ISRCTN) registry (www.isrctn.com). We assessed all protocols as being low or high risk via three possible sources of contamination: 1) participants in the control arm, 2) participants in the intervention arm, 3) therapists in the intervention arm.
RESULTS


Overall, we found that the risk of contamination across all three sources was low for most studies (86 of 100 trial protocols; 86%). We identified 14 studies that had a potentially high risk for contamination. Most of these (N = 10) were identified as risk of contamination arising from a therapist in the intervention arm.
CONCLUSION


The risk of contamination framework we piloted in this study could be a helpful tool for researchers aiming to identify and manage risk of contamination in their trial protocol development. We found that the risk of contamination was relatively low in the psychological therapy trials we sampled for this study, as measured by our framework, and could usually be mitigated through reasonable adjustments to the study design.",2020,"Overall, we found that the risk of contamination across all three sources was low for most studies (86 of 100 trial protocols; 86%).","['contamination: 1) participants in the control arm, 2) participants in the intervention arm, 3) therapists in the intervention arm']",[],['risk of contamination'],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}]",10.0,0.109149,"Overall, we found that the risk of contamination across all three sources was low for most studies (86 of 100 trial protocols; 86%).","[{'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Jacobsen', 'Affiliation': ""Department of Psychology, University of Bath, Bath BA2 7AY; King's College London, Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), De Crespigny Park, London SE5 8AF. Electronic address: p.c.jacobsen@bath.ac.uk.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wood', 'Affiliation': 'Acute and Rehabilitation Directorate Psychology Team, North East London NHS Foundation Trust, Goodmayes Hospital, Barley Lane, Ilford IG3 8XJ; Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road W1T 7DN.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2020.04.005']
191,32402264,Integrated Cognitive-Behavioral Therapy for Social Anxiety and HIV/STI Prevention for Gay and Bisexual Men: A Pilot Intervention Trial.,"Given the alarmingly high HIV and sexually transmitted infection (STI) incidence among gay and bisexual men (GBM) worldwide, there is a critical need for HIV prevention interventions specifically for GBM. Social anxiety, or anxiety about being evaluated in interpersonal situations, is a risk factor for condomless anal sex (CAS) among GBM (e.g., Hart & Heimberg, 2005; Hart, James, Purcell, & Farber, 2008). Social anxiety may also increase substance use in sexual situations, which is another risk factor for HIV/STIs in this risk group (Semple, Strathdee, Zians, McQuaid, & Patterson, 2011). The goal of the Sexual Confidence Study was to provide initial evidence of efficacy for a 10-session integrated cognitive-behavioral therapy for social anxiety, substance use management in sexual situations, and HIV sexual risk reduction for HIV-negative GBM. Diagnostic and self-report assessments were completed at baseline, posttreatment, 3-month follow-up, and 6-month follow-up. In this open trial design, we observed a 50% reduction in engagement in HIV/STI sexual risk behavior at 6-month follow-up. We also observed large uncontrolled treatment effect sizes for reductions in social anxiety disorder and problematic alcohol use. These preliminary findings suggest that the present treatment may offer an efficient way of concurrently reducing social anxiety, problematic alcohol use, and the risk of contracting HIV and STIs via CAS with serodiscordant partners among HIV-negative GBM.",2020,We also observed large uncontrolled treatment effect sizes for reductions in social anxiety disorder and problematic alcohol use.,"['Gay and Bisexual Men', 'gay and bisexual men (GBM']",['Integrated Cognitive-Behavioral Therapy'],"['HIV/STI sexual risk behavior', 'Social anxiety, or anxiety', 'Social anxiety']","[{'cui': 'C0019898', 'cui_str': 'Queers'}, {'cui': 'C0005639', 'cui_str': 'Bisexuality'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.01273,We also observed large uncontrolled treatment effect sizes for reductions in social anxiety disorder and problematic alcohol use.,"[{'ForeName': 'Trevor A', 'Initials': 'TA', 'LastName': 'Hart', 'Affiliation': 'Ryerson University and University of Toronto. Electronic address: trevor.hart@ryerson.ca.'}, {'ForeName': 'Syed W', 'Initials': 'SW', 'LastName': 'Noor', 'Affiliation': 'Ryerson University.'}, {'ForeName': 'Julia R G', 'Initials': 'JRG', 'LastName': 'Vernon', 'Affiliation': 'Ryerson University.'}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'Antony', 'Affiliation': 'Ryerson University.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Gardner', 'Affiliation': 'Baycrest Health Sciences and University of Toronto.'}, {'ForeName': 'Conall', 'Initials': 'C', 'LastName': ""O'Cleirigh"", 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School and Fenway Health, Boston.'}]",Behavior therapy,['10.1016/j.beth.2019.09.001']
192,32387014,[Repurposing of chlorpromazine in COVID-19 treatment: the reCoVery study].,"OBJECTIVES


The ongoing COVID-19 pandemic comprises a total of more than 2,350,000 cases and 160,000 deaths. The interest in anti-coronavirus drug development has been limited so far and effective methods to prevent or treat coronavirus infections in humans are still lacking. Urgent action is needed to fight this fatal coronavirus infection by reducing the number of infected people along with the infection contagiousness and severity. Since the beginning of the COVID-19 outbreak several weeks ago, we observe in GHU PARIS Psychiatrie & Neurosciences (Sainte-Anne hospital, Paris, France) a lower prevalence of symptomatic and severe forms of COVID-19 infections in psychiatric patients (∼4%) compared to health care professionals (∼14%). Similar observations have been noted in other psychiatric units in France and abroad. Our hypothesis is that psychiatric patients could be protected from severe forms of COVID-19 by their psychotropic treatments. Chlorpromazine (CPZ) is a phenothiazine derivative widely used in clinical routine in the treatment of acute and chronic psychoses. This first antipsychotic medication has been discovered in 1952 by Jean Delay and Pierre Deniker at Sainte-Anne hospital. In addition, to its antipsychotic effects, several in vitro studies have also demonstrated a CPZ antiviral activity via the inhibition of clathrin-mediated endocytosis. Recently, independent studies revealed that CPZ is an anti-MERS-CoV and an anti-SARS-CoV-1 drug. In comparison to other antiviral drugs, the main advantages of CPZ lie in its biodistribution: (i) preclinical and clinical studies have reported a high CPZ concentration in the lungs (20-200 times higher than in plasma), which is critical because of the respiratory tropism of SARS-CoV-2; (ii) CPZ is highly concentrated in saliva (30-100 times higher than in plasma) and could therefore reduce the contagiousness of COVID-19; (iii) CPZ can cross the blood-brain barrier and could therefore prevent the neurological forms of COVID-19.
METHODS


Our hypothesis is that CPZ could decrease the unfavorable evolution of COVID-19 infection in oxygen-requiring patients without the need for intensive care, but also reduce the contagiousness of SARS-CoV-2. At this end, we designed a pilot, phase III, multicenter, single blind, randomized controlled clinical trial. Efficacy of CPZ will be assessed according to clinical, biological and radiological criteria. The main objective is to demonstrate a shorter time to response (TTR) to treatment in the CPZ+standard-of-care (CPZ+SOC) group, compared to the SOC group. Response to treatment is defined by a reduction of at least one level of severity on the WHO-Ordinal Scale for Clinical Improvement (WHO-OSCI). The secondary objectives are to demonstrate in the CPZ+SOC group, compared to the SOC group: (A) superior clinical improvement; (B) a greater decrease in the biological markers of viral attack by SARS-CoV-2 (PCR, viral load); (C) a greater decrease in inflammatory markers (e.g. CRP and lymphopenia); (D) a greater decrease in parenchymal involvement (chest CT) on the seventh day post-randomization; (E) to define the optimal dosage of CPZ and its tolerance; (F) to evaluate the biological parameters of response to treatment, in particular the involvement of inflammatory cytokines. Patient recruitment along with the main and secondary objectives are in line with WHO 2020 COVID-19 guidelines.
CONCLUSION


This repositioning of CPZ as an anti-SARS-CoV-2 drug offers an alternative and rapid strategy to alleviate the virus propagation and the infection severity and lethality. This CPZ repositioning strategy also avoids numerous developmental and experimental steps and can save precious time to rapidly establish an anti-COVID-19 therapy with well-known, limited and easy to manage side effects. Indeed, CPZ is an FDA-approved drug with an excellent tolerance profile, prescribed for around 70 years in psychiatry but also in clinical routine in nausea and vomiting of pregnancy, in advanced cancer and also to treat headaches in various neurological conditions. The broad spectrum of CPZ treatment - including antipsychotic, anxiolytic, antiemetic, antiviral, immunomodulatory effects along with inhibition of clathrin-mediated endocytosis and modulation of blood-brain barrier - is in line with the historical French commercial name for CPZ, i.e. LARGACTIL, chosen as a reference to its ""LARGe ACTion"" properties. The discovery of those CPZ properties, as for many other molecules in psychiatry, is both the result of serendipity and careful clinical observations. Using this approach, the field of mental illness could provide innovative therapeutic approaches to fight SARS-CoV-2.",2020,The interest in anti-coronavirus drug development has been limited so far and effective methods to prevent or treat coronavirus infections in humans are still lacking.,['psychiatric patients'],"['Chlorpromazine (CPZ', 'CPZ', 'chlorpromazine', 'phenothiazine derivative']","['biological markers of viral attack by SARS-CoV-2 (PCR, viral load); (C) a greater decrease in inflammatory markers (e.g. CRP and lymphopenia', 'parenchymal involvement (chest CT', 'shorter time to response (TTR']","[{'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}]","[{'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}, {'cui': 'C0304370', 'cui_str': 'Phenothiazine derivative'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0622901,The interest in anti-coronavirus drug development has been limited so far and effective methods to prevent or treat coronavirus infections in humans are still lacking.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Plaze', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Université de Paris, Paris, France. Electronic address: m.plaze@ghu-paris.fr.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Attali', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Université de Paris, Paris, France; Physics for medicine Paris, Inserm, ESPCI Paris, CNRS, PSL Research university, université Paris Diderot, Sorbonne Paris Cite, Paris, France.'}, {'ForeName': 'A-C', 'Initials': 'AC', 'LastName': 'Petit', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Institut Pasteur, experimental neuropathology unit, Paris, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Blatzer', 'Affiliation': 'Institut Pasteur, experimental neuropathology unit, Paris, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Simon-Loriere', 'Affiliation': 'Institut Pasteur, G5 evolutionary genomics of RNA viruses, Paris, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Vinckier', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Université de Paris, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cachia', 'Affiliation': ""Université de Paris, Institut de Psychiatrie et Neurosciences de Paris, INSERM, Paris, France; Université de Paris, Laboratoire de Psychologie du développement et de l'Éducation de l'Enfant, CNRS, Paris, France.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Chrétien', 'Affiliation': 'Institut Pasteur, experimental neuropathology unit, Paris, France; GHU PARIS Psychiatrie et Neurosciences, site Sainte-Anne, service de Neuropathologie, Paris, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gaillard', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Université de Paris, Paris, France; Institut Pasteur, experimental neuropathology unit, Paris, France.'}]",L'Encephale,['10.1016/j.encep.2020.04.010']
193,32387209,"Invited commentary on ""The effect of increased abdominal pressure on internal jugular vein catheterization under ultrasound-guidance on conscious patients: A randomised controlled trial"".",,2020,,['conscious patients'],['internal jugular vein catheterization under ultrasound-guidance'],[],"[{'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}]",[],,0.0620143,,"[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Tian', 'Affiliation': 'Department of Critical Care Medicine, Qingpu Branch of Zhongshan Hospital, Fudan University, Shanghai, 201700, China.'}, {'ForeName': 'Haiping', 'Initials': 'H', 'LastName': 'Duan', 'Affiliation': 'Department of Anesthesiology, Wuhan Hospital of Traditional Chinese Medicine, Hubei, 430014, China. Electronic address: dhp19651226@126.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.04.073']
194,32393479,"Comparison of a new versus standard removable offloading device in patients with neuropathic diabetic foot ulcers: a French national, multicentre, open-label randomized, controlled trial.","INTRODUCTION


The offloading is crucial to heal neuropathic diabetic foot ulcer (DFU). Removable offloading are the most used devices.  Orthèse diabète  is a new customized removable knee-high offloading device immobilizing foot and ankle joints, with some specific and innovative features that may improve offloading. We aimed to evaluate the efficiency of  this device  in DFU healing.
RESEARCH, DESIGN AND METHODS


The evaluation of Offloading using a new removable ORTHOsis in DIABetic foot study is a French multicenter (13 centers) randomized controlled trial with blinded end points evaluation. Adults with neuropathic DFU were randomly assigned to either  Orthèse Diabète (experimental device ), or any type of conventional (usually used in France) removable offloading devices (control group). The primary outcome was the 3-month proportion of patients with fully healed DFU.
RESULTS


Among 112 randomized patients (men 78%, age 62±10 years), the primary outcome occurred in 19 (33%) participants using conventional device vs 19 (35%)  Orthèse Diabète  users (p=0.79). Study groups were also comparable in terms of prespecified secondary end points including occurrence of new DFU (25% vs 27% in conventional and experimental groups), ipsilateral lower-limb amputation (4% vs 10%) or infectious complications (14% vs 13%) (p>0.05 for all). Adverse events were comparable between groups, including 4 deaths unrelated to study allocation (1 sudden death, 2 ventricular arrhythmias and 1 pancreatic cancer). Adverse events believed to be related to the device were higher in the  Orthèse Diabète  group than in the control group (15% vs 4%).  Orthèse Diabète  was less frequently worn than conventional devices (46% vs 66%, p=0.04).
CONCLUSIONS


Orthèse Diabète , a new removable offloading orthosis immobilizing foot and ankle joints did not show superiority compared with conventional removable devices in neuropathic DFU healing and cannot be recommended to heal DFU.
TRIAL REGISTRATION NUMBER


NCT01956162.",2020,Adverse events believed to be related to the device were higher in the  Orthèse Diabète  group than in the control group (15% vs 4%).  ,"['112 randomized patients (men 78%, age 62±10 years', 'Adults with neuropathic DFU', 'patients with neuropathic diabetic foot ulcers']","['new versus standard removable offloading device', 'Orthèse Diabète (experimental device ), or any type of conventional (usually used in France) removable offloading devices (control group']","['occurrence of new DFU', 'Adverse events', 'sudden death, 2 ventricular arrhythmias and 1 pancreatic cancer', '3-month proportion of patients with fully healed DFU', 'infectious complications', 'ipsilateral lower-limb amputation']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0406526', 'cui_str': 'Neuropathic ulcer of foot due to diabetes mellitus'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0237568', 'cui_str': 'Experimental device'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0337308', 'cui_str': 'Amputation of lower limb'}]",112.0,0.174542,Adverse events believed to be related to the device were higher in the  Orthèse Diabète  group than in the control group (15% vs 4%).  ,"[{'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Potier', 'Affiliation': 'Diabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France louis.potier@gmail.com.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'François', 'Affiliation': 'Endocrinology, Diabetology and Nutrition, Centre Hospitalier Universitaire de Reims, Reims, France.'}, {'ForeName': 'Dured', 'Initials': 'D', 'LastName': 'Dardari', 'Affiliation': 'Diabetology, Centre Hospitalier Sud Francilien, Corbeil-Essonnes, Paris, France.'}, {'ForeName': 'Marilyne', 'Initials': 'M', 'LastName': 'Feron', 'Affiliation': 'Diabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France.'}, {'ForeName': 'Narimene', 'Initials': 'N', 'LastName': 'Belhatem', 'Affiliation': 'Diabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Nobecourt-Dupuy', 'Affiliation': 'Department of Diabetology, Endocrinology and Nutrition, Centre Hospitalier Universitaire de la Réunion, Saint Denis de la Réunion, France.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Dolz', 'Affiliation': 'Endocrinology Department, Hôpital Bégin, Saint-Mandé, France.'}, {'ForeName': 'Lyse', 'Initials': 'L', 'LastName': 'Bordier', 'Affiliation': 'Endocrinology Department, Hôpital Bégin, Saint-Mandé, France.'}, {'ForeName': 'Roxane', 'Initials': 'R', 'LastName': 'Ducloux', 'Affiliation': 'APHP, Hôpital Corentin-Celton, Centre de Cicatrisation du Pied du Diabétique, Issy les Moulineaux, France.'}, {'ForeName': 'Abdelkader', 'Initials': 'A', 'LastName': 'Chibani', 'Affiliation': 'Department of Diabetology, Endocrinology and Nutrition, Centre Hospitalier Gonesse, Gonesse, France.'}, {'ForeName': 'Dominique-François', 'Initials': 'DF', 'LastName': 'Eveno', 'Affiliation': 'Department of Functional Rehabilitation, Centre Hospitalier La Tourmaline, La Tourmaline, France.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Crea Avila', 'Affiliation': 'Department of Diabetology, Endocrinology and Nutrition, Centre Hospitalier Régional de Metz-Thionville, Thionville, France.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Sultan', 'Affiliation': 'Department of Endocrinology, Diabetology and Nutrition, CHRU Montpellier, Montpellier, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Baillet-Blanco', 'Affiliation': 'Department of Endocrinology, Diabetology and Nutrition, CHU Bordeaux, Haut Lévèque Hospital, Pessac, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Rigalleau', 'Affiliation': 'Department of Endocrinology, Diabetology and Nutrition, CHU Bordeaux, Haut Lévèque Hospital, Pessac, France.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Gand', 'Affiliation': 'INSERM CIC 1402, University of Poitiers, CHU Poitiers, Poitiers, France.'}, {'ForeName': 'Pierre-Jean', 'Initials': 'PJ', 'LastName': 'Saulnier', 'Affiliation': 'INSERM CIC 1402, University of Poitiers, CHU Poitiers, Poitiers, France.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Velho', 'Affiliation': 'INSERM, UMR_S 1138, Centre de Recherche des Cordeliers, Paris, France.'}, {'ForeName': 'Ronan', 'Initials': 'R', 'LastName': 'Roussel', 'Affiliation': 'Diabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Pellenc', 'Affiliation': 'Vascular Surgery Department, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Dupré', 'Affiliation': 'Diabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Malgrange', 'Affiliation': 'Endocrinology, Diabetology and Nutrition, Centre Hospitalier Universitaire de Reims, Reims, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Marre', 'Affiliation': 'Diabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France.'}, {'ForeName': 'Kamel', 'Initials': 'K', 'LastName': 'Mohammedi', 'Affiliation': 'Department of Endocrinology, Diabetology and Nutrition, CHU Bordeaux, Haut Lévèque Hospital, Pessac, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-000954']
195,32393654,Strengthening effects of bone marrow mononuclear cells with intensive atorvastatin in acute myocardial infarction.,"OBJECTIVE


To test whether intensive atorvastatin (ATV) increases the efficacy of transplantation with autologous bone marrow mononuclear cells (MNCs) in patients suffering from anterior ST-elevated myocardial infarction (STEMI).
METHODS


This clinical trial was under a 2×2 factorial design, enrolling 100 STEMI patients, randomly into four groups of regular (RA) or intensive ATV (IA) with MNCs or placebo. The primary endpoint was the change of left ventricular ejection fraction (LVEF) at 1-year follow-up from baseline, primarily assessed by MRI. The secondary endpoints included other parameters of cardiac function, remodelling and regeneration determined by MRI, echocardiography, positron emission tomography (PET) and biomarkers.
RESULTS


All the STEMI patients with transplantation of MNCs showed significantly increased LVEF change values than those with placebo (p=0.01) with only in the IA+MNCs patients group demonstrating significantly elevation of LVEF than in the IA+placebo group (+12.6% (95%CI 10.4 to 19.3) vs +5.0% (95%CI 4.0 to 10.0), p=0.001), pointing to a better synergy between ATV and MNCs (p=0.019). PET analysis revealed significantly increased viable areas of myocardium (p=0.015), while the scar sizes (p=0.026) and blood aminoterminal pro-B-type natriuretic peptide (p<0.034) reduced. All these above benefits of MNCs were also attributed to IA+MNCs instead of RA+MNCs group of patients with STEMI.
CONCLUSIONS


Intensive ATV treatment augments the therapeutic efficacy of MNCs in patients with anterior STEMI at the convalescent stage. The treatment with the protocol of intensive ATV and MNC combination offers a clinically essential approach for myocardial infarction.
TRIAL REGISTRATION NUMBER


NCT00979758.",2020,"PET analysis revealed significantly increased viable areas of myocardium (p=0.015), while the scar sizes (p=0.026) and blood aminoterminal pro-B-type natriuretic peptide (p<0.034) reduced.","['acute myocardial infarction', 'enrolling 100 STEMI patients', 'patients with anterior STEMI at the convalescent stage', 'patients suffering from anterior ST-elevated myocardial infarction (STEMI']","['IA+placebo', 'autologous bone marrow mononuclear cells (MNCs', 'intensive atorvastatin (ATV', 'regular (RA) or intensive ATV (IA) with MNCs or placebo', 'bone marrow mononuclear cells with intensive atorvastatin', 'intensive ATV and MNC combination', 'placebo']","['viable areas of myocardium', 'LVEF change values', 'cardiac function, remodelling and regeneration determined by MRI, echocardiography, positron emission tomography (PET) and biomarkers', 'blood aminoterminal pro-B-type natriuretic peptide', 'elevation of LVEF', 'scar sizes', 'change of left ventricular ejection fraction (LVEF', 'therapeutic efficacy of MNCs']","[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C1294062', 'cui_str': 'Mononuclear cell count'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0210243', 'cui_str': 'atevirdine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574187', 'cui_str': 'Manchu language'}]","[{'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027061', 'cui_str': 'Cardiac muscle (tissue)'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0565965', 'cui_str': 'Change values'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1294062', 'cui_str': 'Mononuclear cell count'}]",100.0,0.276779,"PET analysis revealed significantly increased viable areas of myocardium (p=0.015), while the scar sizes (p=0.026) and blood aminoterminal pro-B-type natriuretic peptide (p<0.034) reduced.","[{'ForeName': 'Yue-Jin', 'Initials': 'YJ', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China yangyjfw@126.com.'}, {'ForeName': 'Hai-Yan', 'Initials': 'HY', 'LastName': 'Qian', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yong-Jian', 'Initials': 'YJ', 'LastName': 'Geng', 'Affiliation': 'The Center for Cardiovascular Biology and Atherosclerosis, Department of Internal Medicine, University of Texas McGovern School of Medicine at Houston, Houston, Texas, USA.'}, {'ForeName': 'Run-Lin', 'Initials': 'RL', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Center for Cardiac Critical Care, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart Lung and Blood Vessel Diseases, Beijing, China.'}, {'ForeName': 'Xia-Qiu', 'Initials': 'XQ', 'LastName': 'Tian', 'Affiliation': 'Center for Cardiac Critical Care, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart Lung and Blood Vessel Diseases, Beijing, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Beijing, China.'}, {'ForeName': 'Pei-Sen', 'Initials': 'PS', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Shen', 'Affiliation': 'Department of Nuclear Medicine, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Min-Jie', 'Initials': 'MJ', 'LastName': 'Lu', 'Affiliation': 'Department of Magnetic Resonance Imaging, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shi-Hua', 'Initials': 'SH', 'LastName': 'Zhao', 'Affiliation': 'Department of Magnetic Resonance Imaging, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wei-Chun', 'Initials': 'WC', 'LastName': 'Wu', 'Affiliation': 'Department of Echocardiography, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jun-Yan', 'Initials': 'JY', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yu-Yan', 'Initials': 'YY', 'LastName': 'Xiong', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Open heart,['10.1136/openhrt-2019-001139']
196,30677788,Targeting the hepcidin-ferroportin pathway in anaemia of chronic kidney disease.,"AIMS


Erythropoiesis-stimulating agents used to treat anaemia in patients with chronic kidney disease (CKD) have been associated with cardiovascular adverse events. Hepcidin production, controlled by bone morphogenic protein 6 (BMP6), regulates iron homeostasis via interactions with the iron transporter, ferroportin. High hepcidin levels are thought to contribute to increased iron sequestration and subsequent anaemia in CKD patients. To investigate alternative therapies to erythropoiesis-stimulating agents for CKD patients, monoclonal antibodies, LY3113593 and LY2928057, targeting BMP6 and ferroportin respectively, were tested in CKD patients.
METHODS


Preclinical in vitro/vivo data and clinical data in healthy subjects and CKD patients were used to illustrate the translation of pharmacological properties of LY3113593 and LY2928057, highlighting the novelty of targeting these nodes within the hepcidin-ferroportin pathway.
RESULTS


LY2928057 bound ferroportin and blocked interactions with hepcidin, allowing iron efflux, leading to increased serum iron and transferrin saturation levels and increased hepcidin in monkeys and humans. In CKD patients, LY2928057 led to slower haemoglobin decline and reduction in ferritin (compared to placebo). Serum iron increase was (mean [90% confidence interval]) 1.98 [1.46-2.68] and 1.36 [1.22-1.51] fold-relative to baseline following LY2928057 600 mg and LY311593 150 mg respectively in CKD patients. LY3113593 specifically blocked BMP6 binding to its receptor and produced increases in iron and transferrin saturation and decreases in hepcidin preclinically and clinically. In CKD patients, LY3113593 produced an increase in haemoglobin and reduction in ferritin (compared to placebo).
CONCLUSION


LY3113593 and LY2928057 pharmacological effects (serum iron and ferritin) were translated from preclinical-to-clinical development. Such interventions may lead to new CKD anaemia treatments.",2019,LY3113593 specifically blocked BMP6 binding to its receptor and produced increases in iron and transferrin saturation and decreases in hepcidin preclinically and clinically.,"['patients with chronic kidney disease (CKD', 'healthy subjects and CKD patients']",[],"['haemoglobin and reduction in ferritin', 'serum iron and transferrin saturation levels', 'Serum iron increase', 'haemoglobin decline and reduction in ferritin', 'iron and transferrin saturation', 'LY3113593 and LY2928057 pharmacological effects (serum iron and ferritin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],"[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0151900', 'cui_str': 'Serum iron raised'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0235518,LY3113593 specifically blocked BMP6 binding to its receptor and produced increases in iron and transferrin saturation and decreases in hepcidin preclinically and clinically.,"[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sheetz', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Barrington', 'Affiliation': 'Eli Lilly and Company, Windlesham, Surrey, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Callies', 'Affiliation': 'Eli Lilly and Company, Paris, France.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Berg', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'McColm', 'Affiliation': 'Eli Lilly and Company, Windlesham, Surrey, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Marbury', 'Affiliation': 'Orlando Clinical Research Center, Orlando, Florida, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Decker', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Dyas', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Stephanie M E', 'Initials': 'SME', 'LastName': 'Truhlar', 'Affiliation': 'Eli Lilly and Company, San Diego, California, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Benschop', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Donmienne', 'Initials': 'D', 'LastName': 'Leung', 'Affiliation': 'Eli Lilly and Company, San Diego, California, USA.'}, {'ForeName': 'Jolene', 'Initials': 'J', 'LastName': 'Berg', 'Affiliation': 'DaVita Clinical Research, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Derrick R', 'Initials': 'DR', 'LastName': 'Witcher', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.13877']
197,32394218,Landiolol hydrochloride for prevention of atrial fibrillation during esophagectomy: a randomized controlled trial.,"INTRODUCTION


Landiolol hydrochloride reduces the incidence of perioperative atrial fibrillation (AF) in cardiac surgery; however, little evidence is available regarding its effects in other types of surgery, including esophagectomy. We assessed the hypothesis that landiolol reduces perioperative AF and other complications associated with esophagectomy.
METHODS


This single-center, randomized, double-blind, parallel-group study enrolled patients scheduled for esophagectomy. Patients were divided into those given landiolol at 3 μg/kg/min or placebo for 24 h. The primary outcome was the proportion of patients who developed AF within 96 h starting at 9:00 AM on the day of surgery. The secondary outcomes were the proportion of patients whose AF appeared within 24 h, other complications based on the Clavien-Dindo classification, and the intensive care unit and hospital stays.
RESULTS


Despite early study termination, 80 patients were screened, and 56 were enrolled (28/group) from September 2016 to June 2018. AF occurred within 96 h of surgery in six (21.4%) patients in the landiolol group and five (17.9%) patients in the placebo group (odds ratio, 1.26; 95% confidence interval, 0.33-4.7) and within 24 h of surgery in three (10.7%) patients in the landiolol group and two (7.1%) patients in the placebo group. There were no significant differences in the incidence of complications or in the number of intensive care unit or hospital stays between the groups.
CONCLUSION


Although our small sample size prevents definitive conclusions, landiolol might not reduce the occurrence of AF or other complications.
TRIAL REGISTRATION


UMIN, UMIN000024040. Registered 13 September 2016, http://www.umin.ac.jp/ctr/index/htm.",2020,"There were no significant differences in the incidence of complications or in the number of intensive care unit or hospital stays between the groups.
","['cardiac surgery', '80 patients were screened, and 56 were enrolled (28/group) from September 2016 to June 2018', 'atrial fibrillation during esophagectomy']","['esophagectomy', 'Landiolol hydrochloride', 'landiolol at 3\u2009μg/kg/min or placebo', 'placebo']","['AF', 'number of intensive care unit or hospital stays', 'proportion of patients whose AF appeared within 24\u2009h, other complications based on the Clavien-Dindo classification, and the intensive care unit and hospital stays', 'incidence of complications', 'proportion of patients who developed AF']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0905464', 'cui_str': 'landiolol'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",80.0,0.551778,"There were no significant differences in the incidence of complications or in the number of intensive care unit or hospital stays between the groups.
","[{'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Aoki', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-Ku, Hamamatsu-shi, Shizuoka, 431-3192, Japan. ysyaoki27@gmail.com.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Kawasaki', 'Affiliation': 'Biostatistics Section, Clinical Research Centre, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Ide', 'Affiliation': 'Uehiro Research Division for iPS Cell Ethics, Center for iPS Cell Research and Application, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': 'Department of Anesthesiology, Shizuoka General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Department of Gastroenterological Surgery, Shizuoka General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Junichiro', 'Initials': 'J', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Anesthesiology, Shizuoka General Hospital, Shizuoka, Japan.'}]",JA clinical reports,['10.1186/s40981-020-00338-3']
198,32394650,[Significance and operation mode of moxibustion intervention for the group under quarantine after close contact with COVID-19].,"On the base of the idea of traditional Chinese medicine as ""disease prevention"", the mode and the protocol of the moxibustion intervention for the group under quarantine after close contact with coronavirus disease 2019 (COVID-19) were explored. The group under quarantine after close contact with COVID-19 was taken as the subjects. By the non-contact physician-patient communication network platform co-developed by China Association of Acupuncture-Moxibustion, Hunan Provincial Association of Acupuncture-Moxibustion, Data Center of China Academy of Chinese Medical Sciences and Yuge Medicine Company, an exploratory randomized controlled trial was designed. A total of 100 cases were included and randomized into a moxibustion group and a conventional intervention group, 50 cases in each one. In the moxibustion group, moxibustion intervention was used. In the conventional intervention group, the conventional observation was adopted without moxibusiton intervention applied. The outcomes included the symptoms changes, e.g. anxiety, emotional disturbance, fatigue, headache and diarrhea, as well as whether quarantine release and the case confirmed or not, etc. The results were evaluated before intervention, in 14 days of intervention and 2 weeks after intervention separately. In this research, on the base of internet plus technology and with the internet communication platform adopted, through mobile phone WeChat App, it was to implement the subject screen, the random allocation and the instruction of moxibustion intervention as well as the quality control of patient's diary and data collection. It is anticipated that the significance and the implementation mode of moxibustion intervention can be assessed preliminarily for the group under quarantine after close contact with COVID-19.",2020,"The outcomes included the symptoms changes, e.g. anxiety, emotional disturbance, fatigue, headache and diarrhea, as well as whether quarantine release and the case confirmed or not, etc.",['A total of 100 cases'],"['moxibustion intervention', 'moxibustion', 'conventional intervention']","['symptoms changes, e.g. anxiety, emotional disturbance, fatigue, headache and diarrhea, as well as whether quarantine release and the case confirmed or not, etc']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0013985', 'cui_str': 'Emotional Disturbances'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0034386', 'cui_str': 'Quarantine'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]",100.0,0.0282429,"The outcomes included the symptoms changes, e.g. anxiety, emotional disturbance, fatigue, headache and diarrhea, as well as whether quarantine release and the case confirmed or not, etc.","[{'ForeName': 'Mai-Lan', 'Initials': 'ML', 'LastName': 'Liu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Ai', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Guo-Bin', 'Initials': 'GB', 'LastName': 'Dai', 'Affiliation': 'Business School of Central South University.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'First Affiliated Hospital of Hunan University of CM.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Xiao-Rong', 'Initials': 'XR', 'LastName': 'Chang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Bao-Yan', 'Initials': 'BY', 'LastName': 'Liu', 'Affiliation': 'China Academy of Chinese Medical Sciences, Beijing 100700.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20200224-k0004']
199,32395099,Enhancing nicotine replacement therapy usage and adherence through a mobile intervention: Secondary data analysis of a single-arm feasibility study in Mexico.,"INsTRODUCTION


Nicotine Replacement Therapy (NRT) is an effective treatment for smoking cessation. However, medication usage and adherence remain a challenge that contributes to low smoking cessation rates. In Mexico, 8 in 10 smokers are interested in quitting. However, only 6% of Mexican smokers use medication for smoking cessation. The objective of this study is to assess the feasibility and acceptability of a mobile health (mHealth) intervention to increase usage and adherence of NRT in Mexico.
METHODS


The study involves a secondary data analysis. Forty smokers were recruited to participate in a single-arm pilot study. Participants received an mHealth intervention that uses tablet-based decision support software to drive a 12-week text messaging smoking cessation program and pharmacotherapy support. The intervention allows two-way interactivity text messaging between participants and a tobacco treatment specialist. NRT was offered to participants in accordance with practice guidelines in Mexico. Outcome measures included utilization of NRT, text messaging interactivity with the program, and biochemically verified abstinence at 12 weeks.
RESULTS


Thirty smokers met the criteria for use of NRT. Average age of participants was 38.1 years (SD=10.7), and they were primarily male (56.7%) with at least an undergraduate degree (60%). All participants requested NRT at baseline, and 60% requested a refill at week 4. During the 12-week intervention period, participants sent 620 messages to the program (mean=20.6, SD=18.34) of which 79 messages (12.7%) were related to NRT. Three themes were identified in the messages related to NRT: enthusiasm, instructions, and side effects. At 12 weeks, 40% of participants reported using NRT <75% of the days. Finally, 30% of participants (9/30) were biochemically verified abstinent using intention-to-treat analysis at 12 weeks.
CONCLUSIONS


An mHealth intervention appears to offer a promising strategy to increase usage and adherence of NRT in Mexico. Additional testing as a formal randomized clinical trial appears warranted.",2020,Participants received an mHealth intervention that uses tablet-based decision support software to drive a 12-week text messaging smoking cessation program and pharmacotherapy support.,"['Average age of participants was 38.1 years (SD=10.7), and they were primarily male (56.7%) with at least an undergraduate degree (60', 'Mexico', 'Thirty smokers met the criteria for use of NRT', 'Forty smokers']","['Nicotine Replacement Therapy (NRT', 'mHealth intervention that uses tablet-based decision support software to drive a 12-week text messaging smoking cessation program and pharmacotherapy support', 'NRT', 'mobile health (mHealth) intervention']","['utilization of NRT, text messaging interactivity with the program, and biochemically verified abstinence at 12 weeks']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0439230', 'cui_str': 'week'}]",40.0,0.0560818,Participants received an mHealth intervention that uses tablet-based decision support software to drive a 12-week text messaging smoking cessation program and pharmacotherapy support.,"[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Cartujano-Barrera', 'Affiliation': 'Department of Cancer Prevention and Control, Hackensack University Medical Center, Hackensack, United States.'}, {'ForeName': 'Rosibel', 'Initials': 'R', 'LastName': 'Rodríguez-Bolaños', 'Affiliation': 'Departamento de Investigación sobre Tabaco, Instituto Nacional de Salud Pública, Cuernavaca, Mexico.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Arana-Chicas', 'Affiliation': 'Department of Cancer Prevention and Control, Hackensack University Medical Center, Hackensack, United States.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Gallegos-Carrillo', 'Affiliation': 'Unidad de Investigación Epidemiológica y en Servicios de Salud, Delegación Morelos, Instituto Mexicano del Seguro Social, Cuernavaca, Mexico.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'N Flores', 'Affiliation': 'Unidad de Investigación Epidemiológica y en Servicios de Salud, Delegación Morelos, Instituto Mexicano del Seguro Social, Cuernavaca, Mexico.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Pérez-Rubio', 'Affiliation': 'Laboratorio HLA, Instituto Nacional de Enfermedades Respiratorias, Ciudad de Mexico, Mexico.'}, {'ForeName': 'Ramcés', 'Initials': 'R', 'LastName': 'Falfán-Valencia', 'Affiliation': 'Laboratorio HLA, Instituto Nacional de Enfermedades Respiratorias, Ciudad de Mexico, Mexico.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'F Ellerbeck', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, United States.'}, {'ForeName': 'Luz Myriam', 'Initials': 'LM', 'LastName': 'Reynales-Shigematsu', 'Affiliation': 'Departamento de Investigación sobre Tabaco, Instituto Nacional de Salud Pública, Cuernavaca, Mexico.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Cupertino', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, United States.'}]",Tobacco induced diseases,['10.18332/tid/120076']
200,32395278,Development and validation of nomograms for predicting overall and cancer-specific survival in young patients with non-small cell lung cancer.,"Background


Young patients with non-small cell lung cancer (NSCLC) represent a distinct subgroup of patients with this disease. This study aimed to construct nomograms to predict the overall survival (OS) and cancer-specific survival (CSS) of young patients with NSCLC.
Methods


NSCLC patients under 50 years old diagnosed between 2010 and 2016 were selected from the Surveillance, Epidemiology, and End Results (SEER) database and randomly divided into training (n=1,357) and validation (n=678) cohorts at a ratio of 2:1. Independent prognostic factors for OS or CSS were identified through the log-rank test, Cox proportional hazards models or competing risk model and further integrated to construct nomograms. The predictive capability of the nomogram was assessed by Harrell's concordance index (C-index), the calibration curve and risk group stratification.
Results


A total of 2,035 patients were enrolled. In the training cohort, insurance, marital status, histological type, grade, T stage, N stage and surgery were identified as independent prognostic for OS and CSS. The C-index value were 0.759 [95% confidence interval (CI): 0.731-0.787] for OS and 0.810 (95% CI: 0.803-0.818) for BCSS in the training cohort and 0.751 (95% CI: 0.711-0.790) for OS and 0.807 (95% CI: 0.795-0.819) for CSS in the validation cohort. The calibration curves showed optimal agreement between the predicted and actual survival both in internal and external validation. In addition, patients in the validation cohort within different risk groups exhibited significantly different survival even in each TNM stage.
Conclusions


Nomograms were developed and validated to predict OS and CSS of young patients with NSCLC in our study. A prospective study with more potential prognostic factors and the latest TNM classification is required to ameliorate this model.",2020,The C-index value were 0.759 [95% confidence interval (CI): 0.731-0.787] for OS and 0.810,"['young patients with NSCLC.\nMethods\n\n\nNSCLC patients under 50 years old diagnosed between 2010 and 2016 were selected from the Surveillance, Epidemiology, and End Results (SEER) database and randomly divided into training (n=1,357) and validation (n=678) cohorts at a ratio of 2:1', '2,035 patients were enrolled', 'young patients with non-small cell lung cancer', '\n\n\nYoung patients with non-small cell lung cancer (NSCLC']",[],"['survival', 'overall survival (OS) and cancer-specific survival (CSS', 'C-index value']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",[],"[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",2035.0,0.0726775,The C-index value were 0.759 [95% confidence interval (CI): 0.731-0.787] for OS and 0.810,"[{'ForeName': 'Yizhou', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai 200032, China.'}, {'ForeName': 'Yihua', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai 200032, China.'}]",Journal of thoracic disease,['10.21037/jtd.2020.03.03']
201,32395294,Spontaneous ventilation versus mechanical ventilation during video-assisted thoracoscopic surgery for spontaneous pneumothorax: a study protocol for multicenter randomized controlled trial.,"Background


With the evolution and adoption of video-assisted thoracoscopic surgery (VATS), options for anesthesia control have also seen major developments. Intubated anesthesia with single lung mechanical ventilation VATS (MV-VATS) is considered the standard of care in VATS. However, this type of ventilation strategy has been associated with several adverse effects, which can trigger complications and increase the overall surgical risk. In order to avoid intubated anesthesia related adverse effects, non-intubated spontaneous ventilation VATS (SV-VATS) strategies have been proposed in recent years and widely applied.
Methods


We established a two-arm parallel multicenter randomized controlled trial for comparative analysis of the outcomes of patients undergoing either SV-VATS or MV-VATS for spontaneous pneumothorax. Outcomes of interest include safety during operation, total analgesic dose, recovery time, postoperative complication rates, postoperative pain score, length of hospitalization, inflammation index, medical cost, etc. The recruitment target is 316 patients. Patients will be eligible if their chest CT is diagnosed with ""localized lung bullae"" and need VATS resection. Patients will be randomized into the SV-VATS (test group) or MV-VATS (control group) after signing informed consent and surgical anesthesia evaluation.
Discussion


This protocol has been approved by the Research Ethics Committee of the First Affiliated Hospital of Guangzhou Medical university. Results will be presented at national and international meetings and conferences and published in peer-reviewed journals. We will also disseminate the main results to all participants in a letter. Non-intubated SV-VATS offered a more individual choice of anesthetics and surgical method for spontaneous pneumothorax patients.
Trial registration


NCT03016858; pre-results.",2020,"Non-intubated SV-VATS offered a more individual choice of anesthetics and surgical method for spontaneous pneumothorax patients.
","['316 patients', 'spontaneous pneumothorax', 'patients undergoing either SV-VATS or MV-VATS for spontaneous pneumothorax', 'spontaneous pneumothorax patients']","['video-assisted thoracoscopic surgery (VATS', 'SV-VATS', 'Intubated anesthesia with single lung mechanical ventilation VATS (MV-VATS', 'Spontaneous ventilation versus mechanical ventilation during video-assisted thoracoscopic surgery', 'MV-VATS (control group) after signing informed consent and surgical anesthesia evaluation']","['overall surgical risk', 'safety during operation, total analgesic dose, recovery time, postoperative complication rates, postoperative pain score, length of hospitalization, inflammation index, medical cost, etc']","[{'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149781', 'cui_str': 'Spontaneous pneumothorax'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}]","[{'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0412771', 'cui_str': 'Spontaneous respiration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.175773,"Non-intubated SV-VATS offered a more individual choice of anesthetics and surgical method for spontaneous pneumothorax patients.
","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Cui', 'Affiliation': 'Department of Thoracic Surgery, First Affiliated Hospital of Guangzhou Medical University, National Respiratory Disease Clinical Research Center, Guangzhou 510120, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Department of Thoracic Surgery, First Affiliated Hospital of Guangzhou Medical University, National Respiratory Disease Clinical Research Center, Guangzhou 510120, China.'}, {'ForeName': 'Hengrui', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': 'Department of Thoracic Surgery, First Affiliated Hospital of Guangzhou Medical University, National Respiratory Disease Clinical Research Center, Guangzhou 510120, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': 'Department of Thoracic Surgery, First Affiliated Hospital of Guangzhou Medical University, National Respiratory Disease Clinical Research Center, Guangzhou 510120, China.'}, {'ForeName': 'Jingpei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, First Affiliated Hospital of Guangzhou Medical University, National Respiratory Disease Clinical Research Center, Guangzhou 510120, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic Surgery, First Affiliated Hospital of Guangzhou Medical University, National Respiratory Disease Clinical Research Center, Guangzhou 510120, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesia, First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, First Affiliated Hospital of Guangzhou Medical University, National Respiratory Disease Clinical Research Center, Guangzhou 510120, China.'}, {'ForeName': 'Jianxing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Thoracic Surgery, First Affiliated Hospital of Guangzhou Medical University, National Respiratory Disease Clinical Research Center, Guangzhou 510120, China.'}]",Journal of thoracic disease,['10.21037/jtd.2020.02.13']
202,32395319,Long-term results of a single-center prospective randomized trial assessing efficacy of a shortened course of adjuvant chemotherapy after radical cystectomy in patients with locally advanced bladder cancer.,"Introduction


This study assesses the efficacy and tolerability of two cycles of adjuvant chemotherapy (AC) with gemcitabine and cisplatin after radical cystectomy in patients with a high risk of progression of muscle-invasive urothelial bladder cancer as compared to chemotherapy at relapse, in a prospective randomized study.
Material and methods


From 2008 to 2013, all patients after radical cystectomy at our institution for primary or recurrent urothelial bladder cancer with stage pT3-4 and/or pN+ on histopathology and without contraindications to combination cisplatin-based chemotherapy, were randomized either to two cycles of gemcitabine and cisplatin chemotherapy or to follow-up and chemotherapy at the time of relapse. The study endpoints were overall, cancer-specific, and disease-free survival.
Results


The study included 100 patients, of whom 53 received AC and the other 47 were assigned to the control arm. Out of 53 allocated to AC arm, 16 patients did not start chemotherapy or received only one cycle of AC. The median follow-up for patients in the AC and control arms was 88 and 86 months, respectively. In the AC arm the hazard ratio for death from any cause, death from bladder cancer, and disease relapse were 0.70 (95% CI 0.45-1.11; p = 0.13), 0.84 (95% CI 0.50-1.41; p = 0.51), and 0.77 (95% CI 0.46-1.28; p = 0.31), respectively.
Conclusions


Two cycles of AC with gemcitabine and cisplatin in patients with high-risk urothelial bladder cancer after radical cystectomy does not improve overall, cancer-specific, and disease-free survival. Only 53% of patients randomized to AC received the entire planned treatment.",2020,"In the AC arm the hazard ratio for death from any cause, death from bladder cancer, and disease relapse were 0.70 (95% CI 0.45-1.11; p = 0.13), 0.84 (95% CI 0.50-1.41; p = 0.51), and 0.77 (95% CI 0.46-1.28; p = 0.31), respectively.
","['patients with a high risk of progression of muscle-invasive urothelial bladder cancer', 'patients with locally advanced bladder cancer', 'at our institution for primary or recurrent urothelial bladder cancer with stage pT3-4 and/or pN+ on histopathology and without contraindications to combination cisplatin-based chemotherapy', 'patients with high-risk urothelial bladder cancer after', '100 patients, of whom 53 received AC and the other 47 were assigned to the control arm']","['adjuvant chemotherapy (AC) with gemcitabine and cisplatin after radical cystectomy', 'radical cystectomy', 'adjuvant chemotherapy', 'gemcitabine and cisplatin chemotherapy or to follow-up and chemotherapy', 'gemcitabine and cisplatin']","['hazard ratio for death from any cause, death from bladder cancer, and disease relapse', 'overall, cancer-specific, and disease-free survival', 'efficacy and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332393', 'cui_str': 'pT3 category'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",100.0,0.107976,"In the AC arm the hazard ratio for death from any cause, death from bladder cancer, and disease relapse were 0.70 (95% CI 0.45-1.11; p = 0.13), 0.84 (95% CI 0.50-1.41; p = 0.51), and 0.77 (95% CI 0.46-1.28; p = 0.31), respectively.
","[{'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Zhegalik', 'Affiliation': 'Department of Urology, N.N. Alexandrov National Research Cancer Center, Minsk, Belarus.'}, {'ForeName': 'Sergey L', 'Initials': 'SL', 'LastName': 'Polyakov', 'Affiliation': 'Department of Urology, N.N. Alexandrov National Research Cancer Center, Minsk, Belarus.'}, {'ForeName': 'Alexander I', 'Initials': 'AI', 'LastName': 'Rolevich', 'Affiliation': 'Department of Urology, N.N. Alexandrov National Research Cancer Center, Minsk, Belarus.'}, {'ForeName': 'Alexander N', 'Initials': 'AN', 'LastName': 'Volkov', 'Affiliation': 'Department of Urology, N.N. Alexandrov National Research Cancer Center, Minsk, Belarus.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Minich', 'Affiliation': 'Department of Urology, N.N. Alexandrov National Research Cancer Center, Minsk, Belarus.'}, {'ForeName': 'Vladimir Ju', 'Initials': 'VJ', 'LastName': 'Vasilevich', 'Affiliation': 'Department of Urology, N.N. Alexandrov National Research Cancer Center, Minsk, Belarus.'}, {'ForeName': 'Andrey A', 'Initials': 'AA', 'LastName': 'Mokhort', 'Affiliation': 'Department of Urology, N.N. Alexandrov National Research Cancer Center, Minsk, Belarus.'}, {'ForeName': 'Sergey A', 'Initials': 'SA', 'LastName': 'Krasny', 'Affiliation': 'Department of Urology, N.N. Alexandrov National Research Cancer Center, Minsk, Belarus.'}, {'ForeName': 'Oleg G', 'Initials': 'OG', 'LastName': 'Sukonko', 'Affiliation': 'Department of Urology, N.N. Alexandrov National Research Cancer Center, Minsk, Belarus.'}]",Central European journal of urology,['10.5173/ceju.2020.0032']
203,32395324,Efficacy and safety of fURS in stones larger than 20 mm: is it still the threshold?,"Introduction


The aim of this article was to evaluate the safety and efficiency of flexible ureteroscopy (fURS) in the management of renal calculi larger than 20 mm.
Material and methods


A total of 92 cases with renal calculi were managed with fURS and divided into two groups depending on the size of the stones; <20 mm and >20 mm (Group 1 and Group 2, respectively). The groups were compared with respect to treatment-related parameters including success, complication rates, hospitalization period and need for auxiliary procedures with an emphasis on the rate of infections. Success rates were also compared in each group according to stone location.
Results


Overall success rates after 3 months showed that stone-free rates in both groups were 84.1% (< 20 mm) and 58.33% (>20 mm) respectively (p = 0.008). The success rates of upper/mid pole (100% vs. 80%) and pelvis stones (83.3% vs. 75%) showed no statistically significant difference (p = 0.5, p = 0.51 respectively). Success rates for stones located in the lower pole were 75% vs. 14.28% respectively (p = 0.008). The rate of infectious complications was significantly higher in cases undergoing fURS for relatively larger stones (22.9%) as compared to smaller calculi (6.8%) (p = 0.032). No complications were recorded in Group 1, while 2 cases in Group 2 (4.1%) developed ureteral stricture.
Conclusions


Despite the relatively low stone-free rates in lower pole stones, our current results indicate that fURS can be an effective and safe treatment alternative to PNL in larger renal stones (>20 mm) located in the pelvis and in the upper part of the calyceal system of the involved kidney.",2020,Success rates for stones located in the lower pole were 75% vs. 14.28% respectively (p = 0.008).,"['92 cases with renal calculi were managed with', 'stones larger than 20 mm', 'renal calculi larger than 20 mm']","['fURS', 'flexible ureteroscopy (fURS']","['safety and efficiency', 'Overall success rates', 'stone-free rates', 'success rates of upper/mid pole', 'Efficacy and safety', 'No complications', 'rate of infectious complications', 'ureteral stricture', 'success, complication rates, hospitalization period and need for auxiliary procedures with an emphasis on the rate of infections', 'pelvis stones', 'Success rates']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0549177', 'cui_str': 'Large'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0337815', 'cui_str': 'Poles'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C3887590', 'cui_str': 'Stricture of ureter'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}]",92.0,0.0299937,Success rates for stones located in the lower pole were 75% vs. 14.28% respectively (p = 0.008).,"[{'ForeName': 'Mehmet Ali', 'Initials': 'MA', 'LastName': 'Karagöz', 'Affiliation': 'Department of Urology, Kafkas University Faculty of Medicine, Kars, Turkey.'}, {'ForeName': 'Ismet Bilger', 'Initials': 'IB', 'LastName': 'Erihan', 'Affiliation': 'Department of Urology, Kafkas University Faculty of Medicine, Kars, Turkey.'}, {'ForeName': 'Ömer Gökhan', 'Initials': 'ÖG', 'LastName': 'Doluoğlu', 'Affiliation': 'Department of Urology, Ankara Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Çağlar', 'Initials': 'Ç', 'LastName': 'Uğurlu', 'Affiliation': 'Department of Urology, Kafkas University Faculty of Medicine, Kars, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Bağcıoğlu', 'Affiliation': 'Department of Urology, Kafkas University Faculty of Medicine, Kars, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Uslu', 'Affiliation': 'Department of Urology, Kafkas University Faculty of Medicine, Kars, Turkey.'}, {'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Sarıca', 'Affiliation': 'Department of Urology, Kafkas University Faculty of Medicine, Kars, Turkey.'}]",Central European journal of urology,['10.5173/ceju.2020.0056']
204,32396095,Home-Based Functional Electrical Stimulation-Assisted Hand Therapy Video Games for Children with Hemiplegia: Development and Proof-of-Concept.,"We describe the development and three case reports of a home-based intervention for children with hand hemiplegia that integrates custom video games with contralaterally controlled functional electrical stimulation (CCFES). With CCFES, stimulated opening of the more-affected hand is modulated by volitional opening of the less-affected hand. Video games that solicit goal-oriented, skill-requiring movement have shown promise for treating hemiplegia, but they have not previously been combined with electrical stimulation in children. Three children ages 8, 9, and 11 with moderate-to-severe hand hemiplegia were assigned six weeks of therapy in lab and at home. The goal was to determine if children could tolerate 9 lab treatment sessions and administer up to 7.5 hrs/wk of CCFES video game therapy at home. The feasibility of this intervention for home use was assessed by device logs, end-of-treatment interviews, and motor function/impairment assessments. With caregiver help, the children were all able to attend 9 lab sessions and built up to 7.5 hrs/wk of therapy by week 3. They averaged 5-7 hrs/wk of home intervention overall. Motor outcomes improved for all three participants at treatment end, but mostly regressed at 4-weeks follow-up. Individual improvements at treatment end exceeded minimum detectable or clinically important thresholds for Assisting Hands Assessment, Fugl-Meyer Assessment, and Melbourne Motor Assessment 2. We found preliminary indications that CCFES-integrated video game therapy can provide a high dose of hand motor control therapy at home and in the lab. Improvements in motor outcomes were also observed, but more development and study is needed.",2020,"Individual improvements at treatment end exceeded minimum detectable or clinically important thresholds for Assisting Hands Assessment, Fugl-Meyer Assessment, and Melbourne Motor Assessment 2.","['Children with Hemiplegia', 'Three children ages 8, 9, and 11 with moderate-to-severe hand hemiplegia', 'children with hand hemiplegia that integrates']","['custom video games with contralaterally controlled functional electrical stimulation (CCFES', 'CCFES-integrated video game therapy', 'home-based intervention', 'CCFES video game therapy', 'Home-Based Functional Electrical Stimulation-Assisted Hand Therapy Video Games']",['Motor outcomes'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0729315', 'cui_str': 'Hand therapy'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}]",3.0,0.063265,"Individual improvements at treatment end exceeded minimum detectable or clinically important thresholds for Assisting Hands Assessment, Fugl-Meyer Assessment, and Melbourne Motor Assessment 2.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Curby', 'Affiliation': ''}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Suder', 'Affiliation': ''}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Katholi', 'Affiliation': ''}, {'ForeName': 'Jayme S', 'Initials': 'JS', 'LastName': 'Knutson', 'Affiliation': ''}]",IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society,['10.1109/TNSRE.2020.2992036']
205,32396179,Effect of Surgery vs Functional Bracing on Functional Outcome Among Patients With Closed Displaced Humeral Shaft Fractures: The FISH Randomized Clinical Trial.,"Importance


Humeral shaft fractures traditionally have been treated nonsurgically, but there has been a steady increase in the rate of surgery over the past 2 decades without high-quality evidence to justify the trend.
Objective


To compare the effectiveness of surgical treatment with open reduction and internal plate fixation to nonsurgical treatment with functional bracing in the treatment of closed humeral shaft fractures.
Design, Setting, and Participants


Randomized clinical trial conducted at 2 university hospital trauma centers in Finland, enrollment between November 2012 and January 2018 with a final follow-up of January 2019. A total of 82 adult patients with closed, unilateral, displaced humeral shaft fracture met criteria for inclusion. Patients were excluded if they had cognitive disabilities preventing them from following the protocol or had multimorbidity or multiple trauma.
Interventions


Patients were randomly assigned to surgical treatment with open reduction and internal plate fixation (n = 38) or to nonsurgical treatment with functional bracing (n = 44).
Main Outcome and Measure


The primary outcome was Disabilities of Arm, Shoulder and Hand (DASH) score at 12 months (range, 0 to 100 points, 0 denotes no disability and 100 extreme disability; minimal clinically important difference, 10 points).
Results


Among 82 patients who were randomized (mean age, 48.9 years; 38 women [46%]; 44 men [54%]), 78 (95%) completed the trial. Thirteen (30%) of the patients assigned to functional bracing underwent surgery during the 12-month follow-up period to promote healing of the fracture. At 12 months, the mean DASH score was 8.9 (95% CI, 4.2 to 13.6) in the surgery group and 12.0 (95% CI, 7.7 to 16.4) in the bracing group (between-group difference, -3.1 points; 95% CI, -9.6 to 3.3; P = .34). Eleven patients (25%) allocated to functional bracing developed fracture nonunion. Three patients (8%) allocated to surgery developed a temporary radial nerve palsy.
Conclusions and Relevance


Among patients with closed humeral shaft fracture, internal fixation surgery, compared with nonoperative functional bracing, did not significantly improve functional outcomes at 12 months. However, the substantial amount of treatment crossover from nonoperative to surgical treatment should be considered when interpreting the trial results.
Trial Registration


ClinicalTrials.gov Identifier: NCT01719887.",2020,"The primary outcome was Disabilities of Arm, Shoulder and Hand","['closed humeral shaft fractures', 'patients with closed humeral shaft fracture, internal fixation surgery', ' 38 women [46%]; 44 men [54%]), 78 (95%) completed the trial', 'Patients were excluded if they had cognitive disabilities preventing them from following the protocol or had multimorbidity or multiple trauma', 'Patients', '2 university hospital trauma centers in Finland, enrollment between November 2012 and January 2018 with a final follow-up of January 2019', '82 adult patients with closed, unilateral, displaced humeral shaft fracture met criteria for inclusion', 'With Closed Displaced Humeral Shaft Fractures', '82 patients who were randomized (mean age, 48.9 years']","['surgical treatment with open reduction and internal plate fixation to nonsurgical treatment with functional bracing', 'Surgery vs Functional Bracing', 'surgical treatment with open reduction and internal plate fixation (n\u2009=\u200938) or to nonsurgical treatment with functional bracing (n\u2009=\u200944']","['mean DASH score', 'Disabilities of Arm, Shoulder and Hand', 'DASH) score', 'functional outcomes', 'fracture nonunion']","[{'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0588210', 'cui_str': 'Bone structure of shaft of humerus'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0026771', 'cui_str': 'Multiple injuries'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1828220', 'cui_str': 'Application of brace'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0016665', 'cui_str': 'Fracture, ununited'}]",82.0,0.141729,"The primary outcome was Disabilities of Arm, Shoulder and Hand","[{'ForeName': 'Lasse', 'Initials': 'L', 'LastName': 'Rämö', 'Affiliation': 'Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Bakir O', 'Initials': 'BO', 'LastName': 'Sumrein', 'Affiliation': 'Orthopedics and Traumatology, Tampere University Hospital, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Vesa', 'Initials': 'V', 'LastName': 'Lepola', 'Affiliation': 'Orthopedics and Traumatology, Tampere University Hospital, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Tuomas', 'Initials': 'T', 'LastName': 'Lähdeoja', 'Affiliation': 'Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Ranstam', 'Affiliation': 'Mdas AB, Ystad, Sweden.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Paavola', 'Affiliation': 'Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Teppo', 'Initials': 'T', 'LastName': 'Järvinen', 'Affiliation': 'Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Simo', 'Initials': 'S', 'LastName': 'Taimela', 'Affiliation': 'Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.3182']
206,32396180,Effect of Biomechanical Footwear on Knee Pain in People With Knee Osteoarthritis: The BIOTOK Randomized Clinical Trial.,"Importance


Individually calibrated biomechanical footwear therapy may improve pain and physical function in people with symptomatic knee osteoarthritis, but the benefits of this therapy are unclear.
Objective


To assess the effect of a biomechanical footwear therapy vs control footwear over 24 weeks of follow-up.
Design, Setting, and Participants


Randomized clinical trial conducted at a Swiss university hospital. Participants (N = 220) with symptomatic, radiologically confirmed knee osteoarthritis were recruited between April 20, 2015, and January 10, 2017. The last participant visit occurred on August 15, 2017.
Interventions


Participants were randomized to biomechanical footwear involving shoes with individually adjustable external convex pods attached to the outsole (n = 111) or to control footwear (n = 109) that had visible outsole pods that were not adjustable and did not create a convex walking surface.
Main Outcomes and Measures


The primary outcome was knee pain at 24 weeks of follow-up assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscore standardized to range from 0 (no symptoms) to 10 (extreme symptoms). The secondary outcomes included WOMAC physical function and stiffness subscores and the WOMAC global score, all ranging from 0 (no symptoms) to 10 (extreme symptoms) at 24 weeks of follow-up, and serious adverse events.
Results


Among the 220 randomized participants (mean age, 65.2 years [SD, 9.3 years]; 104 women [47.3%]), 219 received the allocated treatment and 213 (96.8%) completed follow-up. At 24 weeks of follow-up, the mean standardized WOMAC pain subscore improved from 4.3 to 1.3 in the biomechanical footwear group and from 4.0 to 2.6 in the control footwear group (between-group difference in scores at 24 weeks of follow-up, -1.3 [95% CI, -1.8 to -0.9]; P < .001). The results were consistent for WOMAC physical function subscore (between-group difference, -1.1 [95% CI, -1.5 to -0.7]), WOMAC stiffness subscore (between-group difference, -1.4 [95% CI, -1.9 to -0.9]), and WOMAC global score (between-group difference, -1.2 [95% CI, -1.6 to -0.8]) at 24 weeks of follow-up. Three serious adverse events occurred in the biomechanical footwear group compared with 9 in the control footwear group (2.7% vs 8.3%, respectively); none were related to treatment.
Conclusions and Relevance


Among participants with knee pain from osteoarthritis, use of biomechanical footwear compared with control footwear resulted in an improvement in pain at 24 weeks of follow-up that was statistically significant but of uncertain clinical importance. Further research would be needed to assess long-term efficacy and safety, as well as replication, before reaching conclusions about the clinical value of this device.
Trial Registration


ClinicalTrials.gov Identifier: NCT02363712.",2020,"The results were consistent for WOMAC physical function subscore (between-group difference, -1.1","['Swiss university hospital', 'Participants (N\u2009=\u2009220) with symptomatic, radiologically confirmed knee osteoarthritis were recruited between April 20, 2015, and January 10, 2017', '220 randomized participants (mean age, 65.2 years [SD, 9.3 years]; 104 women [47.3%]), 219 received the allocated treatment and 213 (96.8%) completed follow-up', 'People With Knee Osteoarthritis', 'people with symptomatic knee osteoarthritis', 'participants with knee pain from osteoarthritis']","['Biomechanical Footwear', 'biomechanical footwear therapy', 'calibrated biomechanical footwear therapy', 'biomechanical footwear involving shoes with individually adjustable external convex pods attached to the outsole (n\u2009=\u2009111) or to control footwear (n\u2009=\u2009109) that had visible outsole pods that were not adjustable and did not create a convex walking surface']","['pain and physical function', 'WOMAC physical function subscore', 'WOMAC stiffness subscore', 'Knee Pain', 'serious adverse events', 'pain', 'knee pain at 24 weeks of follow-up assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscore standardized to range from 0 (no symptoms) to 10 (extreme symptoms', 'mean standardized WOMAC pain subscore', 'WOMAC physical function and stiffness subscores and the WOMAC global score, all ranging from 0 (no symptoms) to 10 (extreme symptoms', 'WOMAC global score']","[{'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0336894', 'cui_str': 'Footwear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",220.0,0.172357,"The results were consistent for WOMAC physical function subscore (between-group difference, -1.1","[{'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Reichenbach', 'Affiliation': 'Institute for Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Felson', 'Affiliation': 'Arthritis Research UK Centre for Epidemiology, Centre for Musculoskeletal Research, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester, England.'}, {'ForeName': 'Cesar A', 'Initials': 'CA', 'LastName': 'Hincapié', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Heldner', 'Affiliation': 'Institute for Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Bütikofer', 'Affiliation': 'Clinical Trials Unit, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Lenz', 'Affiliation': 'Clinical Trials Unit, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Bruno R', 'Initials': 'BR', 'LastName': 'da Costa', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Harald M', 'Initials': 'HM', 'LastName': 'Bonel', 'Affiliation': 'Department for Diagnostic, Interventional, and Pediatric Radiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Jones', 'Affiliation': 'Centre for Health Sciences Research, School of Health Sciences, University of Salford Manchester, Manchester, England.'}, {'ForeName': 'Gillian A', 'Initials': 'GA', 'LastName': 'Hawker', 'Affiliation': 'Department of Medicine and Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.""}]",JAMA,['10.1001/jama.2020.3565']
207,32394821,[Evaluation of a Manualized Group Program for Siblings of Children with Diseases or Disabilities].,"Evaluation of a Manualized Group Program for Siblings of Children with Diseases or Disabilities  This study evaluates a manualized group program for siblings of children with life-threatening/life-limiting diseases or disabilities. The program aims to activate resources and to reduce emotional and behavioral problems, using cognitive-behavioral methods and experience-based interventions. In this multi-center study, 13 GeschwisterTREFFs were conducted by 11 study sites in Germany. Prior to and after the intervention 97 siblings aged 7 to 14 years and their parents were examined with standardized questionnaires. At baseline, the siblings of children with diseases or disabilities showed significant more emotional and behavioral problems compared to the respective norm samples. After the intervention, the siblings reported declined problem behavior scores that were mostly in the range of the particular norm values. Furthermore, the children indicated a significant improvement of self-esteem, self-efficacy, school competences and relations to their siblings. However, parents reported more problem behavior and less health-related quality of life of their children at both assessments. The present multi-center study showed the interventions' feasibility in different settings and confirmed expected improvements of target variables during the intervention period. Randomized-controlled trails are warranted to verify our results.",2020,"Furthermore, the children indicated a significant improvement of self-esteem, self-efficacy, school competences and relations to their siblings.","['siblings of children with life-threatening/life-limiting diseases or disabilities', '97 siblings aged 7 to 14 years and their parents', 'Siblings of Children with Diseases or Disabilities', '13 GeschwisterTREFFs were conducted by 11 study sites in Germany']","['manualized group program', 'Manualized Group Program']","['problem behavior and less health-related quality of life', 'problem behavior scores', 'self-esteem, self-efficacy, school competences and relations to their siblings', 'emotional and behavioral problems']","[{'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",13.0,0.0188384,"Furthermore, the children indicated a significant improvement of self-esteem, self-efficacy, school competences and relations to their siblings.","[{'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Engelhardt-Lohrke', 'Affiliation': 'Elternhilfe für krebskranke Kinder Leipzig e.V Philipp-Rosenthal-Str. 21 04103 Leipzig Deutschland Elternhilfe für krebskranke Kinder Leipzig e.V.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schepper', 'Affiliation': 'Selbstständige Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie Universitätsklinikum Leipzig Deutschland Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie.'}, {'ForeName': 'Jessy', 'Initials': 'J', 'LastName': 'Herrmann', 'Affiliation': 'Selbstständige Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie Universitätsklinikum Leipzig Deutschland Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Kowalewski', 'Affiliation': 'Institut für Sozialmedizin in der Pädiatrie Augsburg (ISPA e.V.) Deutschland Institut für Sozialmedizin in der Pädiatrie Augsburg (ISPA e.V.).'}, {'ForeName': 'Thore', 'Initials': 'T', 'LastName': 'Spilger', 'Affiliation': 'Institut für Sozialmedizin in der Pädiatrie Augsburg (ISPA e.V.) Deutschland Institut für Sozialmedizin in der Pädiatrie Augsburg (ISPA e.V.).'}, {'ForeName': 'Cornelius', 'Initials': 'C', 'LastName': 'Weiß', 'Affiliation': 'Selbstständige Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie Universitätsklinikum Leipzig Deutschland Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Martini', 'Affiliation': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie Medizinische Fakultät am Universitätsklinikum Carl Gustav Carus Technische Universität Dresden Deutschland Klinik und Poliklinik für Psychiatrie und Psychotherapie.'}]",Praxis der Kinderpsychologie und Kinderpsychiatrie,['10.13109/prkk.2020.69.3.203']
208,32395379,Pro-inflammatory Cytokine Levels and Cancer-related Fatigue in Breast Cancer Survivors: Effects of an Exercise Adherence Program.,"Purpose


This study aimed to determine the effect of an exercise intervention on subjective cancer-related fatigue (CRF) and pro-inflammatory cytokine levels in breast cancer survivors (BCS).
Methods


BCS with greater than moderate CRF (≥ 4) were recruited and randomly assigned to experimental or control groups. The experimental group participated in a 12-week exercise adherence program (Better Life after Cancer - Energy, Strength, and Support; BLESS). Interleukin (IL)-6 and tumor necrosis factor-α (TNF-α) levels were determined at 3 time points (M1: baseline, M2: post-intervention, and M4: 6 months after intervention). Subjective fatigue was measured using the Korean version of the revised Piper Fatigue Scale.
Results


In this analysis of participants with physiological fatigue measures available (19 experimental, 21 control), there were no statistically significant differences in IL-6 (F = 1.157,  p  = 0.341), TNF-α levels (F = 0.878,  p  = 0.436), and level of fatigue (F = 2.067,  p  = 0.118) between the 2 groups at baseline. Fatigue in the experimental group showed statistically significant improvement compared to the control only at M2 ( p  = 0.022). There was no significant relationship between subjective and physiological fatigue at the 3 measurement points.
Conclusion


The BLESS intervention improved CRF in BCS immediately at post-intervention, and this study presents clinical feasibility for the management of CRF in BCS in the early survivorship phase who are already experiencing fatigue.",2020,Fatigue in the experimental group showed statistically significant improvement compared to the control only at M2 ( p  = 0.022).,"['Breast Cancer Survivors', 'breast cancer survivors (BCS']","['exercise intervention', 'Interleukin ', 'Exercise Adherence Program', 'exercise adherence program (Better Life after Cancer - Energy, Strength, and Support; BLESS']","['subjective cancer-related fatigue (CRF) and pro-inflammatory cytokine levels', 'TNF-α levels', 'IL)-6 and tumor necrosis factor-α (TNF-α) levels', 'Fatigue', 'IL-6', 'Subjective fatigue', 'level of fatigue', 'subjective and physiological fatigue']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}]",,0.0334036,Fatigue in the experimental group showed statistically significant improvement compared to the control only at M2 ( p  = 0.022).,"[{'ForeName': 'Sung Hae', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, College of Health. Welfare and Education, Tongmyong University, Busan, Korea.'}, {'ForeName': 'Yoon Kyung', 'Initials': 'YK', 'LastName': 'Song', 'Affiliation': 'Department of Sports Industry Studies, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Jeehee', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'College of Nursing, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Yun Hee', 'Initials': 'YH', 'LastName': 'Ko', 'Affiliation': 'College of Nursing, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Hyojin', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Min Jae', 'Initials': 'MJ', 'LastName': 'Kang', 'Affiliation': 'Department of Sports Industry Studies, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Hyunki', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Biobehavioral Center, Mo-Im Kim Nursing Research Institute, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Hyangkyu', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Mo-Im Kim Nursing Research Institute, College of Nursing, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Mo-Im Kim Nursing Research Institute, College of Nursing, Yonsei University, Seoul, Korea.'}]",Journal of breast cancer,['10.4048/jbc.2020.23.e22']
209,32395387,Efficacy of non-surgical treatment accompanied by professional toothbrushing in the treatment of chronic periodontitis in patients with type 2 diabetes mellitus: a randomized controlled clinical trial.,"Purpose


The present study aimed to evaluate the clinical benefit of additional toothbrushing accompanying non-surgical periodontal treatment on oral and general health in patients with type 2 diabetes mellitus (T2DM).
Methods


We conducted a doubled-blind randomized controlled trial in 60 T2DM patients between June 2013 and June 2014. The patients were randomly assigned to the scaling and root planing (SRP) group; the scaling and root planing with additional toothbrushing (SRPAT) group, in which additional toothbrushing was performed by toothpick methods; or the control group. Microbiological and oral examinations were performed for up to 12 weeks following treatment. Non-surgical treatment was conducted in the experimental groups. The SRP group received scaling and root planing and the SRPAT group received additional toothbrushing with the Watanabe method once a week from the first visit through the fifth visit. The primary outcomes were changes in haemoglobin A1c (or glycated haemoglobin; HbA1c) levels, serum endotoxin levels, and interleukin-1 beta levels. Periodontal health status was measured by periodontal pocket depth, the calculus index, and bleeding on probing (BOP).
Results


Both the SRP and SRPAT groups showed improvements in periodontal health and HbA1c, but the SRPAT group showed significantly less BOP than the SRP group. Furthermore, only the SRPAT group showed a statistically significant decrease in serum endotoxin levels.
Conclusions


Non-surgical periodontal treatment was effective in improving HbA1c and serum endotoxin levels in T2DM patients. Furthermore, non-surgical treatment with additional tooth brushing had a more favourable effect on gingival bleeding management.Trial RegistrationClinical Research Information Service Identifier: KCT000416.",2020,"Both the SRP and SRPAT groups showed improvements in periodontal health and HbA1c, but the SRPAT group showed significantly less BOP than the SRP group.","['patients with type 2 diabetes mellitus', 'patients with type 2 diabetes mellitus (T2DM', '60 T2DM patients between June 2013 and June 2014', 'T2DM patients']","['scaling and root planing (SRP) group; the scaling and root planing with additional toothbrushing (SRPAT', 'additional toothbrushing accompanying non-surgical periodontal treatment', 'non-surgical treatment accompanied by professional toothbrushing']","['changes in haemoglobin A1c (or glycated haemoglobin; HbA1c) levels, serum endotoxin levels, and interleukin-1 beta levels', 'periodontal pocket depth, the calculus index, and bleeding on probing (BOP', 'Periodontal health status', 'BOP', 'periodontal health and HbA1c', 'HbA1c and serum endotoxin levels', 'serum endotoxin levels', 'chronic periodontitis', 'gingival bleeding management']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2363849', 'cui_str': 'Non-surgical treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0014264', 'cui_str': 'Bacterial endotoxin'}, {'cui': 'C0021753', 'cui_str': 'interleukin-1, beta'}, {'cui': 'C0031094', 'cui_str': 'Periodontal pocket'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",60.0,0.0362263,"Both the SRP and SRPAT groups showed improvements in periodontal health and HbA1c, but the SRPAT group showed significantly less BOP than the SRP group.","[{'ForeName': 'Jae Young', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Preventive and Public Health Dentistry, Seoul National University School of Dentistry, Seoul, Korea.'}, {'ForeName': 'Yoon Young', 'Initials': 'YY', 'LastName': 'Choi', 'Affiliation': 'Department of Preventive and Public Health Dentistry, Seoul National University School of Dentistry, Seoul, Korea.'}, {'ForeName': 'Youngnim', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Department of Immunology and Molecular Microbiology, Seoul National University School of Dentistry, Seoul, Korea.'}, {'ForeName': 'Bo Hyoung', 'Initials': 'BH', 'LastName': 'Jin', 'Affiliation': 'Department of Preventive and Public Health Dentistry, Seoul National University School of Dentistry, Seoul, Korea.'}]",Journal of periodontal & implant science,['10.5051/jpis.2020.50.2.83']
210,32395434,"Comparison of patient-reported outcomes of treatment with low- and intermediate molecular weight hyaluronic acid in Japanese patients with symptomatic knee osteoarthritis: A prospective, randomized, single-blind trial.","Objectives


The objective of this study was to compare the clinical outcomes of treatment with low- or intermediate-molecular-weight hyaluronic acid (HA) in patients with knee osteoarthritis (OA).
Methods


In total, 59 patients with OA who fulfilled the criteria of the American College of Rheumatology for OA were enrolled. Patients were randomly assigned in a 1:1 ratio to the low- or intermediate-molecular-weight HA group. An intraarticular injection of HA into the knee joint was performed five times per week. The visual analog scale for pain (pain VAS) and Japanese Knee Osteoarthritis Measure (JKOM) score were analyzed at baseline and week 6 to assess the outcomes.
Results


Pain VAS and JKOM score were significantly improved in both groups. At follow-up, there were no significant between-group differences in pain VAS or total JKOM score. Moreover, reduction in pain VAS and JKOM score was not significantly different between the two groups.
Conclusions


Both low- and intermediate-molecular-weight HA have significant efficacy in the first-line treatment of patients with knee OA as indicated by patient-reported outcomes. However, there does not appear to be any difference between the efficacy of low- and intermediate-molecular-weight HA as indicated by the JKOM score. We believe that the results of this study provide important insights into the clinical management of Japanese patients with knee OA.",2020,"At follow-up, there were no significant between-group differences in pain VAS or total JKOM score.","['patients with knee osteoarthritis (OA', 'Japanese patients with knee OA', '59 patients with OA who fulfilled the criteria of the American College of Rheumatology for OA were enrolled', 'Japanese patients with symptomatic knee osteoarthritis']","['low- or intermediate-molecular-weight hyaluronic acid (HA', 'low- and intermediate molecular weight hyaluronic acid', 'low- or intermediate-molecular-weight HA group']","['visual analog scale for pain (pain VAS) and Japanese Knee Osteoarthritis Measure (JKOM) score', 'pain VAS and JKOM score', 'pain VAS or total JKOM score', 'Pain VAS and JKOM score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",59.0,0.0328174,"At follow-up, there were no significant between-group differences in pain VAS or total JKOM score.","[{'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Mochizuki', 'Affiliation': 'Department of Orthopedic Surgery, Kamagaya General Hospital, Chiba, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Ikari', 'Affiliation': ""Department of Orthopedic Surgery, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Yano', 'Affiliation': ""Department of Orthopedic Surgery, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Okazaki', 'Affiliation': ""Department of Orthopedic Surgery, Tokyo Women's Medical University, Tokyo, Japan.""}]","Asia-Pacific journal of sports medicine, arthroscopy, rehabilitation and technology",['10.1016/j.asmart.2020.04.001']
211,32395439,Short Term Intake of  Undaria pinnatifida  Does Not Affect Bone Biomarkers in Young Korean Women with Low Calcium Intake.,"Calcium intake is essential for bone health, but young Korean women have low calcium intakes. Seaweeds have high calcium content, which may affect calcium metabolism. Twenty nine females aged 18-39 years with low calcium intake (< 400 mg/day) participated in a 19-day open-label randomized controlled trial. During the first five days, participants adhered to a controlled-feeding protocol followed by a two-week supplementation period in free-living conditions. The treatment group (n = 14) received an additional 200 mg Ca/day through  Undaria pinnatifida  and  Porphyra  in meals during the controlled-feeding period, and as  U. pinnatifida  noodles during days 6-19. Mineral intake (Ca, P, Mg, Na, and K) was assessed from diet composites and three 24-hour recalls during the controlled-feeding and free-living periods, respectively. Fasting serum levels of calcium, 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D (1,25[OH]D), phosphorus, parathyroid hormone (PTH), and alkaline phosphatase (ALP) were assessed at baseline, day 6, and day 19. Statistical analyses were performed by Student's  t -test and mixed ANOVA. Mean intakes of all minerals during days 1-5 and mean Ca and Mg intakes during days 6-19 were greater in the treatment group compared to the control group. No group effect or group and time interaction was observed in serum biomarkers. Serum 1,25(OH)D increased while PTH and ALP tended to decrease on day 6 but returned to baseline values on day 20. Short-term intake of  U. pinnatifida  and  Porphyra  does not affect calcium metabolism in young Korean women with low calcium intakes.
Trial Registration


Clinical Research Information Service Identifier: KCT0003307.",2020,"Serum 1,25(OH)D increased while PTH and ALP tended to decrease on day 6 but returned to baseline values on day 20.","['Twenty nine females aged 18-39 years with low calcium intake (< 400 mg/day) participated in a 19-day open-label randomized controlled trial', 'young Korean women with low calcium intakes', 'Young Korean Women with Low Calcium Intake', 'young Korean women']","['Calcium intake', 'additional 200 mg Ca/day through  Undaria pinnatifida  and  Porphyra  in meals']","['Serum 1,25(OH)D increased while PTH and ALP', 'Mineral intake (Ca, P, Mg, Na, and K', 'Ca and Mg intakes', 'serum biomarkers', 'calcium metabolism', 'Fasting serum levels of calcium, 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D (1,25[OH]D), phosphorus, parathyroid hormone (PTH), and alkaline phosphatase (ALP', 'Mean intakes', 'Undaria pinnatifida']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0860967', 'cui_str': 'Calcium low'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0619485', 'cui_str': 'A 19'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0489458', 'cui_str': 'Calcium intake'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1030485', 'cui_str': 'Undaria pinnatifida'}, {'cui': 'C0996258', 'cui_str': 'Porphyra'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0518042', 'cui_str': 'Mineral intake'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0370232', 'cui_str': '1,25-dihydroxyvitamin D'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1030485', 'cui_str': 'Undaria pinnatifida'}]",29.0,0.110886,"Serum 1,25(OH)D increased while PTH and ALP tended to decrease on day 6 but returned to baseline values on day 20.","[{'ForeName': 'Clara Yongjoo', 'Initials': 'CY', 'LastName': 'Park', 'Affiliation': 'Department of Food and Nutrition, Chonnam National University, Gwangju 61186, Korea.'}, {'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'Department of Food and Nutrition, Chonnam National University, Gwangju 61186, Korea.'}, {'ForeName': 'Sung Jae', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Integrative Medicine, Korea University College of Medicine, Seoul 02841, Korea.'}]",Clinical nutrition research,['10.7762/cnr.2020.9.2.90']
212,32392574,Autosomal-dominant polycystic kidney disease: tolvaptan use in adolescents and young adults with rapid progression.,"BACKGROUND


The phase 3 Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes (TEMPO 3:4) clinical trial demonstrated the beneficial effect of tolvaptan on kidney growth and function in subjects aged 18-50 years over a 3-year period. However, it did not specifically assess the use of tolvaptan in adolescents and young adults (AYAs) with ADPKD.
METHODS


A post hoc analysis of the TEMPO 3:4 trials was performed for patients aged 18-24 years. The primary outcome was the annual rate of change in total kidney volume (TKV). The secondary outcome was to evaluate long-term safety of tolvaptan using Hy's law of hepatotoxicity.
RESULTS


A total of 51 patients in the 18-24 age group were analyzed (tolvaptan: 29, placebo: 22). The tolvaptan group had a lower mean percentage of TKV growth per year compared to the placebo group (3.9% vs. 6.5%, P = 0.0491). For secondary outcomes, 63 patients in the AYA subgroup were evaluated. In both the AYA and adult groups, none of the patients met the criteria for Hy's law of hepatotoxicity.
CONCLUSIONS


This post hoc analysis suggests that tolvaptan, with appropriate patient selection and management, can provide effective and acceptably safe treatment in AYAs with ADPKD.
IMPACT


Tolvaptan slows the increase in total kidney volume in patients aged 18-24 years with ADPKD.Tolvaptan posed no risk of potential liver injury measured via Hy's law of hepatotoxicity in the AYA stratum.This study suggests that tolvaptan has beneficial outcomes in AYAs.This post hoc analysis suggests the need for additional studies with a larger pediatric patient population.The impact is significant as tolvaptan had not been specifically examined in the AYA patient population previously.",2020,"In both the AYA and adult groups, none of the patients met the criteria for Hy's law of hepatotoxicity.
","['A total of 51 patients in the 18-24 age group were analyzed (tolvaptan: 29', 'patients aged 18-24 years', 'patients aged 18-24 years with', 'adolescents and young adults (AYAs) with ADPKD', '63 patients in the AYA subgroup were evaluated', 'adolescents and young adults with rapid progression', 'subjects aged 18-50 years over a 3-year period']","['tolvaptan', 'ADPKD.Tolvaptan', 'placebo']","['total kidney volume', 'kidney growth and function', 'annual rate of change in total kidney volume (TKV', ""evaluate long-term safety of tolvaptan using Hy's law of hepatotoxicity"", 'TKV growth per year']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0085413', 'cui_str': 'Autosomal dominant polycystic kidney disease'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]","[{'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0023150', 'cui_str': 'Law'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0439508', 'cui_str': '/year'}]",,0.140569,"In both the AYA and adult groups, none of the patients met the criteria for Hy's law of hepatotoxicity.
","[{'ForeName': 'Rupesh', 'Initials': 'R', 'LastName': 'Raina', 'Affiliation': 'Department of Nephrology, Akron Nephrology Associates/Cleveland Clinic Akron General Medical Center, Akron, OH, USA. rraina@akronchildrens.org.'}, {'ForeName': 'Ronith', 'Initials': 'R', 'LastName': 'Chakraborty', 'Affiliation': ""Department of Nephrology, Akron Children's Hospital, Akron, OH, USA.""}, {'ForeName': 'Meredith E', 'Initials': 'ME', 'LastName': 'DeCoy', 'Affiliation': 'Ohio University Heritage College of Osteopathic Medicine, Athens, OH, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Kline', 'Affiliation': 'Mayo Clinic College of Medicine, Rochester, MN, USA.'}]",Pediatric research,['10.1038/s41390-020-0942-2']
213,32398341,Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE) randomised clinical trial: study protocol.,"INTRODUCTION


Bloodstream infections are a leading cause of mortality and morbidity; the duration of treatment for these infections is understudied.
METHODS AND ANALYSIS


We will conduct an international, multicentre randomised clinical trial of shorter (7 days) versus longer (14 days) antibiotic treatment among hospitalised patients with bloodstream infections. The trial will include 3626 patients across 60 hospitals and 6 countries. We will include patients with blood cultures confirming a pathogenic bacterium after hospital admission. Exclusion criteria will include patient factors (severe immunosuppression), infection site factors (endocarditis, osteomyelitis, undrained abscesses, infected prosthetic material) and pathogen factors ( Staphylococcus aureus ,  Staphylococcus lugdunensis ,  Candida  and contaminant organisms). We will leave the selection of specific antibiotics, doses and route of delivery to the discretion of treating physicians; no placebo control will be used given the diversity of pathogens and sources of bacteraemia. The intervention will be assignment of treatment duration to be 7 versus 14 days. We will minimise selection bias via central randomisation with variable block sizes, with concealed allocation until day 7 of adequate antibiotic treatment. The primary outcome is 90-day survival; we will test whether 7 days is non-inferior to 14 days of treatment, with a non-inferiority margin of 4% absolute mortality. Secondary outcomes include hospital and intensive care unit (ICU) mortality, relapse rates of bacteraemia, hospital and ICU length of stay, mechanical ventilation and vasopressor duration, antibiotic-free days,  C lostridium  difficile  infection, antibiotic allergy and adverse events and colonisation/infection with antibiotic-resistant organisms.
ETHICS AND DISSEMINATION


The study has been approved by the ethics review board at each participating site. Sunnybrook Health Sciences Centre is the central ethics committee. We will disseminate study results via the Canadian Critical Care Trials Group and other collaborating networks to set the global paradigm for antibiotic treatment duration for non-staphylococcal Gram-positive, Gram-negative and anaerobic bacteraemia, among patients admitted to hospital.
TRIAL REGISTRATION NUMBER


The BALANCE (Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness) trial was registered at www.clinicaltrials.gov (registration number: NCT03005145).",2020,"The primary outcome is 90-day survival; we will test whether 7 days is non-inferior to 14 days of treatment, with a non-inferiority margin of 4% absolute mortality.","['patients with blood cultures confirming a pathogenic bacterium after hospital admission', 'hospitalised patients with bloodstream infections', '3626 patients across 60 hospitals and 6 countries', 'patients admitted to hospital']","['antibiotic treatment', 'placebo']","['Antibiotic Length', 'hospital and intensive care unit (ICU) mortality, relapse rates of bacteraemia, hospital and ICU length of stay, mechanical ventilation and vasopressor duration, antibiotic-free days,  C lostridium  difficile  infection, antibiotic allergy and adverse events and colonisation/infection with antibiotic-resistant organisms', '90-day survival', 'non-inferiority margin of 4% absolute mortality', 'Bacteremia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0200949', 'cui_str': 'Blood culture'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0741103', 'cui_str': 'Allergy to antibiotic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",3626.0,0.403099,"The primary outcome is 90-day survival; we will test whether 7 days is non-inferior to 14 days of treatment, with a non-inferiority margin of 4% absolute mortality.","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Daneman', 'Affiliation': 'Division of Infectious Diseases & Clinical Epidemiology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada Nick.Daneman@sunnybrook.ca.'}, {'ForeName': 'Asgar H', 'Initials': 'AH', 'LastName': 'Rishu', 'Affiliation': 'Institute for Clinical Evaluative Sciences, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Ruxandra L', 'Initials': 'RL', 'LastName': 'Pinto', 'Affiliation': 'Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Yaseen M', 'Initials': 'YM', 'LastName': 'Arabi', 'Affiliation': 'Intensive Care Department, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Cook', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hall', 'Affiliation': 'Departments of Critical Care Medicine and Anesthesiology, Pain Management and Perioperative Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': 'Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Muscedere', 'Affiliation': 'Kingston General Hospital, Kingston, Ontario, Canada.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Parke', 'Affiliation': 'The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Reynolds', 'Affiliation': 'Royal Columbian Hospital, New Westminster, British Columbia, Canada.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Rogers', 'Affiliation': 'Centre for Inflammatory Diseases, Monash University School of Clinical Sciences, Melborne, Victoria, Australia.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Shehabi', 'Affiliation': 'Critical Care and Perioperative Medicine, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Fowler', 'Affiliation': 'Departments of Medicine and Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-038300']
214,32398907,Effect of  Agnikarma  (therapeutic heat burns) and  Raktamokshana  (therapeutic bloodletting) in the management of  Kati Sandhigata Vata  (lumbar spondylosis).,"Background


Agnikarma  (therapeutic heat burns) and  Raktamokshana  (therapeutic bloodletting) are the treatment modalities mentioned in Ayurveda texts to combat the clinical condition of  Sandhigata Vata  (osteoarthritis) which occurs due to provoked  Vata Dosha  and/or  Vyana Vayu  overlapped with  Kapha . Lumbar spondylosis is a degenerative disorder presenting with lower back pain, stiffness, numbness, difficulty in movement etc., with evidence of osteophytes and reduced disc height in plain film radiograph.
Aims and Objectives


The aim of the study was to evaluate the role of  Agnikarma  and  Raktamokshana  in the management of  Kati Sandhigata Vata  (lumbar spondylosis).
Materials and Methods


After obtaining CTRI registration, total 32 cases of lumbar spondylosis were registered and allocated into two groups by simple random sampling method. 16 patients were treated with  Agnikarma  with  Panchadhatu   Shalaka  (group A) and 16 patients were treated with  Raktamokshana  by modified  Shringa   Yantra  (group B).
Results


The result was assessed using the Wilcoxon signed-rank test and paired  t -test. Significant results were observed in relieving lower back pain, stiffness, numbness and painful movements in both the groups.
Conclusion


Agnikarma  was found more effective in relieving pain and numbness in lower back and  Raktamokshana  was found better in relieving pain and stiffness of lower back.",2019,"Significant results were observed in relieving lower back pain, stiffness, numbness and painful movements in both the groups.
","['Kati Sandhigata Vata  (lumbar spondylosis', '16 patients were treated with  Agnikarma  with  Panchadhatu   Shalaka  (group A) and 16 patients were treated with', 'total 32 cases of lumbar spondylosis']","['Agnikarma  (therapeutic heat burns) and  Raktamokshana  (therapeutic bloodletting', 'Raktamokshana  by modified  Shringa   Yantra  (group B', '\n\n\nAgnikarma  (therapeutic heat burns) and  Raktamokshana  (therapeutic bloodletting']","['relieving pain and stiffness of lower back', 'relieving lower back pain, stiffness, numbness and painful movements', 'relieving pain and numbness']","[{'cui': 'C0149983', 'cui_str': 'Lumbar spondylosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0150611', 'cui_str': 'Heat therapy'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",16.0,0.0144258,"Significant results were observed in relieving lower back pain, stiffness, numbness and painful movements in both the groups.
","[{'ForeName': 'Foram', 'Initials': 'F', 'LastName': 'Joshi', 'Affiliation': 'Department of Shalyatantra, IPGT and RA, Gujarat Ayurved University, Jamnagar, Gujarat, India.'}, {'ForeName': 'Vyasadeva', 'Initials': 'V', 'LastName': 'Mahanta', 'Affiliation': 'Department of Shalyatantra, AIIA, New Delhi, India.'}, {'ForeName': 'Tukaram S', 'Initials': 'TS', 'LastName': 'Dudhamal', 'Affiliation': 'Department of Shalyatantra, IPGT and RA, Gujarat Ayurved University, Jamnagar, Gujarat, India.'}, {'ForeName': 'Sanjay Kumar', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': 'Department of Shalyatantra, IPGT and RA, Gujarat Ayurved University, Jamnagar, Gujarat, India.'}]",Ayu,['10.4103/ayu.AYU_142_16']
215,32398908,"Efficacy of  Sattvavajaya Chikitsa  in the form of relaxation techniques and  Guda Pippalimula Churna  in the management of  Anidra  (insomnia) - An open labelled, randomized comparative clinical trial.","Background


Condition of insomnia may not be a life-threatening illness, but it has tendency to damage the person's daily life. In the current era of modernization, most of the person are is suffering from stress either it is personal or professional. Stress may cause sleeping problems or make existing problems worse.  Sattvavajaya   Chikitsa  is a specialized type of treatment influencing the psychological aspect of body. It can be applied in the form of  Yogic  practices and other mind control techniques. With this research interest, the present study has been undertaken to assess the efficacy of the  Sattvavajaya   Chikitsa  in the form of relaxation techniques (RT) and  Guda   Pippalimula   Churna  in  Anidra  (insomnia).
Objectives


The objective of the study was to evaluate the efficacy of  Sattvavajaya   Chikitsa  in the form of RT and  Guda   Pippalimula   Churna  in  Anidra .
Materials and Methods


The study was an open-labeled randomized clinical trial in which sixty patients having symptoms of  Anidra  belonging to the age group of 20-60 years were enrolled and received  Sattvavajaya   Chikitsa  (RT) and  Guda   Pippalimula   Churna  orally in 2gm dosage with jaggery for 28 days. The assessment of symptoms was done on the basis of relief in the scores given to signs and symptoms according to their severity.
Results


Both the groups showed significant results in chief as well as associated symptoms of disease. Regarding overall effect of therapy in both the groups, marked improvement is high followed by moderate improvement. No adverse reactions were documented.
Conclusion


Sattvavajaya   Chikitsa  and  Guda   Pippalimula   Churna  are effective on  Anidra , but  Sattvavajaya   Chikitsa  was found more effective in reducing  Manasa  symptoms such as  Chinta  (tension),  Bhaya  (fear) and  Krodha  (anger).",2019,"No adverse reactions were documented.
","['Anidra  (insomnia) ', 'sixty patients having symptoms of  Anidra  belonging to the age group of 20-60 years were enrolled and received']",['Sattvavajaya   Chikitsa  (RT) and  Guda'],"['symptoms of disease', 'Chinta  (tension),  Bhaya  (fear) and  Krodha  (anger', 'adverse reactions', 'Sattvavajaya', 'Conclusion\n\n\nSattvavajaya   Chikitsa  and  Guda']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",,0.0343107,"No adverse reactions were documented.
","[{'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Rawal', 'Affiliation': 'Department of Basic Principles, IPGT and RA, GAU, Jamnagar, Gujarat, India.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Vyas', 'Affiliation': 'Department of Basic Principles, IPGT and RA, GAU, Jamnagar, Gujarat, India.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Baghel', 'Affiliation': 'Department of Basic Principles, IPGT and RA, GAU, Jamnagar, Gujarat, India.'}, {'ForeName': 'Shubhangi', 'Initials': 'S', 'LastName': 'Kamble', 'Affiliation': 'Department of Basic Principles, IPGT and RA, GAU, Jamnagar, Gujarat, India.'}]",Ayu,['10.4103/ayu.AYU_91_17']
216,32398909,Efficacy of  Seetarama Vati  (A Sri Lankan traditional drug) and  Vatari Guggulu  in the management of  Amavata  (rheumatoid arthritis)-an open labeled randomized comparative clinical trial.,"Introduction


Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease caused by type III hypersensitivity reaction due to antigen antibody complexes which deposit at the joints resulting in arthritis. As per the concept of Ayurveda, it can be co-related with  Amavata , the disease arising from deranged metabolism and  Vata  vitiation. Despite of advancement in diagnostic approach of RA, management of it remains challenge.  Vatari Guggulu  and  Seetarama Vati  are the formulations having analgesics properties due to their  Ushna  (metabolism enhancing) and  Tikshna Guna  (micro channel cleaning) and simultaneously possess anti-inflammatory properties.
Aims and Objectives


To evaluate and compare the efficacy of  Vatari Guggulu  and  Seetarama Vati  in the management of  Amavata  w.s.r. to rheumatoid arthritis.
Material and Methods


For the present study, 58 patients were selected and divided into two groups. Patients of group A and group B were given  Vatari Guggulu  and  Seetarama Vati  respectively with warm water after meal for one month. Before administration of trial drugs in both of groups' patients were given 4-6 grams of  Triphala  powder depending upon the  Koshtha  of the patient, on empty stomach early morning for the purpose of  Koshtha Shuddhi  (purgation) for 3 days. In addition to assess effect on signs and symptoms of  Amavata , haematological investigation, biochemical investigation including quantitative C-reactive protein (CRP) and rheumatoid factor (RA factor) and routine urinary examination were carried out before and after treatment in all the registered patients. The effect of therapy was assessed on the basis of changes in score in comparison to end point score.
Discussion


All the cardinal and associate complaints were statistically significant improved after the course of the trial drug. Most of the functional parameters had statistically significant improvement after treatment except left side foot pressure and DAS 28 scale in B group. Biochemical and hematological parameters were within normal limit before and after treatment. The difference of effect of trial drug on chief complaints was statistically insignificant. The difference of effect of trial drug on associate complaints was statistically insignificant. Difference of effect of trial drugs on ESR of both the groups was statistically insignificant. The difference of effect of trial drug on RA factor and CRP between groups was statistically significant. The difference of effect of trial drug on functional parameters between groups were statistically significant.
Conclusion


The study revealed that, though both the trial drugs;  Vatari Guggulu  and  Seetarama Vati  are effective in the management of  Amavata , but clinically  Seetarama Vati  is comparatively more effective than  Vatari Guggulu  in the management of  Amavata .",2019,Most of the functional parameters had statistically significant improvement after treatment except left side foot pressure and DAS 28 scale in B group.,"['Amavata  (rheumatoid', '58 patients were selected and divided into two groups']","['Seetarama Vati  (A Sri Lankan traditional drug) and  Vatari Guggulu', 'Tikshna Guna  (micro channel cleaning', 'Vatari Guggulu  and  Seetarama Vati  respectively with warm water after meal for one month', 'Vatari Guggulu  and  Seetarama Vati']","['quantitative C-reactive protein (CRP) and rheumatoid factor (RA factor) and routine urinary examination', 'functional parameters', 'left side foot pressure and DAS 28 scale', 'ESR', 'chief complaints', 'Biochemical and hematological parameters', 'RA factor and CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0061999', 'cui_str': 'gugulu extract'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C4082115', 'cui_str': 'One month'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0035448', 'cui_str': 'Rheumatoid factor'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0051767', 'cui_str': 'amsonic acid'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}]",58.0,0.0396733,Most of the functional parameters had statistically significant improvement after treatment except left side foot pressure and DAS 28 scale in B group.,"[{'ForeName': 'M G Sandeepanie K', 'Initials': 'MGSK', 'LastName': 'Maragalawaththa', 'Affiliation': 'Medical Officer, Chamal Rajpraksha Ayurved Research Hospital, Hambantola, Srilanka.'}, {'ForeName': 'Mandip', 'Initials': 'M', 'LastName': 'Goyal', 'Affiliation': 'Department of Kayachikitsa, IPGT & RA, Jamnagar, Gujarat, India.'}]",Ayu,['10.4103/ayu.AYU_65_18']
217,32398910,Role of  Terminalia arjuna  Wight and Arn. in the treatment of chronic coronary artery disease from pharmacovigilance point of view.,"Background and Objectives


Terminalia   arjuna  Wight and Arn. ( Arjuna ) has been used in indigenous system for the treatment of cardiac ailments since 500 BC. However, there is a lack of vigilance studies during long-term therapy. The present clinical study was planned to examine the long-term safety of  Arjuna  as an adjunct drug in chronic coronary artery disease (CAD) patients.
Materials and Methods


During the study period, a total of 35 patients of chronic CAD were enrolled to receive  Arjuna  bark extract powder (500 mg three times daily) along with conventional drugs. The control group (35 patients) received conventional drugs alone. Hemogram, liver function tests and kidney function tests were done at baseline and then every 6 months until the end of the study. Electrocardiography was done every 6 months and echocardiography was done yearly for left ventricular ejection fraction and regional wall motion abnormalities. Any adverse drug reactions reported by the patients were also recorded.
Results


The mean age of patients in test and control groups was 60.88 ± 9.02 and 58.51 ± 12.64 years, respectively. There was a predominance of male patients in both the groups. The patients were observed for duration ranging from 9 months to 4 years and 9 months. Other than baring gastritis and constipation, no other noteworthy adverse effects were reported. No significant difference was found in laboratory value on baseline and end of therapy in both the groups.
Conclusion


The results of the present study concluded that  Arjuna  is safe and effective in patients with chronic coronary artery disease.",2019,"No significant difference was found in laboratory value on baseline and end of therapy in both the groups.
","['chronic coronary artery disease (CAD) patients', 'patients with chronic coronary artery disease', '35 patients of chronic CAD']","['conventional drugs alone', 'Arjuna  bark extract powder', 'Electrocardiography']","['adverse drug reactions', 'laboratory value', 'Hemogram, liver function tests and kidney function tests']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]","[{'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0200631', 'cui_str': 'Complete blood count without differential'}, {'cui': 'C0023901', 'cui_str': 'Hepatic function panel'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",,0.0218981,"No significant difference was found in laboratory value on baseline and end of therapy in both the groups.
","[{'ForeName': 'Shridhar', 'Initials': 'S', 'LastName': 'Dwivedi', 'Affiliation': 'Department of Cardiology, National Heart Institute, New Delhi, India.'}, {'ForeName': 'Deepti', 'Initials': 'D', 'LastName': 'Chopra', 'Affiliation': 'Department of Pharmacology, Government Institute of Medical Sciences, Greater Noida, Uttar Pradesh, India.'}, {'ForeName': 'Bharti', 'Initials': 'B', 'LastName': 'Bhandari', 'Affiliation': 'Physiology, Government Institute of Medical Sciences, Greater Noida, Uttar Pradesh, India.'}]",Ayu,['10.4103/ayu.AYU_114_18']
218,32398911,Comparison of antiplaque effectiveness of herbal toothpaste: A randomized triple-blinded cross-over clinical trial.,"Background


Cleansing the teeth with a toothbrush and paste is an indubitable mechanical plaque control method practiced by almost everyone. Eliminating dental plaque is an essential, fundamental and mandatory step to prevent the occurrence of periodontal diseases that are rife globally. The aim of the present study is to compare the antiplaque effectiveness of a prepared herbal and commercially available dentifrice.
Materials and Methods


Thirty healthy individuals within the age group of 18-25 years were recruited to participate in the study. After achieving induced gingivitis and measuring plaque levels using Turesky modification of the Quigley Hein Plaque index in all the subjects, they were randomly divided into test arms A and B. Commercial dentifrice was distributed to one group, whereas the other group received prepared herbal dentifrice. Supervised brushing was carried out for 5 min, and plaque amounts after brushing were noted. After a washout period of 1 week, the same steps were repeated as per the cross-over study protocol. Unpaired  t -test and paired  t -tests were employed with  P  < 0.05.
Results


Both the toothpastes show the difference in plaque scores immediately after brushing when compared to baseline and was statistically significant ( P  = 0.001). The mean plaque scores of commercial dentifrice (1.93 ± 1.52) were less than that of the prepared herbal dentifrice (2.35 ± 1.39) after brushing.
Conclusion


The prepared herbal dentifrice had good antiplaque action. However, the plaque inhibitory action of self-prepared herbal toothpaste was marginally less when compared to commercial dentifrice.",2019,Both the toothpastes show the difference in plaque scores immediately after brushing when compared to baseline and was statistically significant ( P  = 0.001).,['Thirty healthy individuals within the age group of 18-25 years were recruited to participate in the study'],"['herbal toothpaste', 'herbal dentifrice', 'prepared herbal and commercially available dentifrice']","['mean plaque scores', 'plaque scores']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.0184761,Both the toothpastes show the difference in plaque scores immediately after brushing when compared to baseline and was statistically significant ( P  = 0.001).,"[{'ForeName': 'Ramamurthy', 'Initials': 'R', 'LastName': 'Shanmugapriya', 'Affiliation': 'Department of Periodontics, Sri Venkateswara Dental College and Hospital, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Ulaganathan', 'Initials': 'U', 'LastName': 'Arunmozhi', 'Affiliation': 'Department of Periodontics, Sri Venkateswara Dental College and Hospital, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Rathinasamy', 'Initials': 'R', 'LastName': 'Kadhiresan', 'Affiliation': 'Department of Periodontics, Sri Venkateswara Dental College and Hospital, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Sudarsan', 'Initials': 'S', 'LastName': 'Sabitha', 'Affiliation': 'Department of Periodontics, Sri Venkateswara Dental College and Hospital, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Ravikumar', 'Initials': 'R', 'LastName': 'Anirudhya', 'Affiliation': 'Department of Periodontics, Sri Venkateswara Dental College and Hospital, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Govindarajan', 'Initials': 'G', 'LastName': 'Sujatha', 'Affiliation': 'Department of Oral Pathology, Sri Venkateswara Dental College and Hospital, Chennai, Tamil Nadu, India.'}]",Ayu,['10.4103/ayu.AYU_185_19']
219,32336678,Generating randomized trial evidence to optimize treatment in the COVID-19 pandemic.,,2020,,[],[],[],[],[],[],,0.190025,,"[{'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': ""Division of Infectious Diseases (Cheng, Lee), Department of Medicine, and Division of Medical Microbiology (Cheng), Department of Laboratory Medicine, McGill University Health Centre; Clinical Trials Platform (Cheng, Lee), McGill Interdisciplinary Initiative in Infection and Immunity, Montréal, Que.; Division of Infectious Diseases (Tan) and MAP Centre for Urban Health Solutions (Tan), St. Michael's Hospital; Department of Medicine (Tan), University of Toronto, Toronto, Ont.; Department of Pediatrics (Murthy), University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': ""Division of Infectious Diseases (Cheng, Lee), Department of Medicine, and Division of Medical Microbiology (Cheng), Department of Laboratory Medicine, McGill University Health Centre; Clinical Trials Platform (Cheng, Lee), McGill Interdisciplinary Initiative in Infection and Immunity, Montréal, Que.; Division of Infectious Diseases (Tan) and MAP Centre for Urban Health Solutions (Tan), St. Michael's Hospital; Department of Medicine (Tan), University of Toronto, Toronto, Ont.; Department of Pediatrics (Murthy), University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Darrell H S', 'Initials': 'DHS', 'LastName': 'Tan', 'Affiliation': ""Division of Infectious Diseases (Cheng, Lee), Department of Medicine, and Division of Medical Microbiology (Cheng), Department of Laboratory Medicine, McGill University Health Centre; Clinical Trials Platform (Cheng, Lee), McGill Interdisciplinary Initiative in Infection and Immunity, Montréal, Que.; Division of Infectious Diseases (Tan) and MAP Centre for Urban Health Solutions (Tan), St. Michael's Hospital; Department of Medicine (Tan), University of Toronto, Toronto, Ont.; Department of Pediatrics (Murthy), University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Murthy', 'Affiliation': ""Division of Infectious Diseases (Cheng, Lee), Department of Medicine, and Division of Medical Microbiology (Cheng), Department of Laboratory Medicine, McGill University Health Centre; Clinical Trials Platform (Cheng, Lee), McGill Interdisciplinary Initiative in Infection and Immunity, Montréal, Que.; Division of Infectious Diseases (Tan) and MAP Centre for Urban Health Solutions (Tan), St. Michael's Hospital; Department of Medicine (Tan), University of Toronto, Toronto, Ont.; Department of Pediatrics (Murthy), University of British Columbia, Vancouver, BC srinivas.murthy@cw.bc.ca.""}]",CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne,['10.1503/cmaj.200438']
220,32399254,A controlled pilot trial of a nurse-led intervention (Mini-AFTERc) to manage fear of cancer recurrence in patients affected by breast cancer.,"Background


Fear of cancer recurrence (FCR) is common in people affected by breast cancer. FCR is associated with increased health service and medication use, anxiety, depression and reduced quality of life. Existing interventions for FCR are time and resource intensive, making implementation in a National Health Service (NHS) setting challenging. To effectively manage FCR in current clinical practice, less intensive FCR interventions are required. Mini-AFTERc is a structured 30-min counselling intervention delivered over the telephone and is designed to normalise moderate FCR levels by targeting unhelpful behaviours and misconceptions about cancer recurrence.This multi-centre non-randomised controlled pilot trial will investigate the feasibility of delivering the Mini-AFTERc intervention, its acceptability and usefulness, in relation to specialist breast cancer nurses (SBCNs) and patients. This protocol describes the rationale, methods and analysis plan for this pilot trial of the Mini-AFTERc intervention in everyday practice.
Methods


This study will run in four breast cancer centres in NHS Scotland, two intervention and two control centres. SBCNs at intervention centres will be trained to deliver the Mini-AFTERc intervention. Female patients who have completed primary breast cancer treatment in the previous 6 months will be screened for moderate FCR (FCR4 score: 10‑14). Participants at intervention centres will receive the Mini-AFTERc intervention within 2 weeks of recruitment. SBCNs will audio record the intervention telephone discussions with participants. Fidelity of intervention implementation will be assessed from audio recordings. All participants will complete three separate follow-up questionnaires assessing changes in FCR, anxiety, depression and quality of life over 3 months. Normalisation process theory (NPT) will form the framework for semi-structured interviews with 20% of patients and all SBCNs. Interviews will explore participants' experience of the study, acceptability and usefulness of the intervention and factors influencing implementation within clinical practice. The ADePT process will be adopted to systematically problem solve and refine the trial design.
Discussion


Findings will provide evidence for the potential effectiveness, fidelity, acceptability and practicality of the Mini-AFTERc intervention, and will inform the design and development of a large randomised controlled trial (RCT).
Trial registration


ClinicalTrials.gov: NCT0376382. Registered 4th December 2018, https://clinicaltrials.gov/ct2/show/NCT03763825.",2020,"All participants will complete three separate follow-up questionnaires assessing changes in FCR, anxiety, depression and quality of life over 3 months.","['specialist breast cancer nurses (SBCNs) and patients', 'patients affected by breast cancer', 'Female patients who have completed primary breast cancer treatment in the previous 6\u2009months will be screened for moderate FCR (FCR4 score: 10‑14', 'four breast cancer centres in NHS Scotland, two intervention and two control centres', 'people affected by breast cancer']","['nurse-led intervention (Mini-AFTERc', 'Mini-AFTERc intervention']","['FCR, anxiety, depression and quality of life', 'health service and medication use, anxiety, depression and reduced quality of life']","[{'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0233705', 'cui_str': 'Fear of getting cancer'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0445542', 'cui_str': 'Mini'}]","[{'cui': 'C0233705', 'cui_str': 'Fear of getting cancer'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.13518,"All participants will complete three separate follow-up questionnaires assessing changes in FCR, anxiety, depression and quality of life over 3 months.","[{'ForeName': 'Calum T', 'Initials': 'CT', 'LastName': 'McHale', 'Affiliation': '1Division of Population and Behavioural Sciences, School of Medicine, University of St Andrews, St Andrews, KY16 9TF UK.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Cruickshank', 'Affiliation': '2Faculty of Health Sciences and Sport, University of Stirling, Stirling, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Torrens', 'Affiliation': '2Faculty of Health Sciences and Sport, University of Stirling, Stirling, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Armes', 'Affiliation': '3School of Health Sciences, University of Surrey, Guildford, Surrey UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Fenlon', 'Affiliation': '4College of Human and Health Sciences, Swansea University, Swansea, UK.'}, {'ForeName': 'Elspeth', 'Initials': 'E', 'LastName': 'Banks', 'Affiliation': '5National Cancer Research Institute, London, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Kelsey', 'Affiliation': '6School of Computer Science, University of St Andrews, St Andrews, UK.'}, {'ForeName': 'Gerald M', 'Initials': 'GM', 'LastName': 'Humphris', 'Affiliation': '1Division of Population and Behavioural Sciences, School of Medicine, University of St Andrews, St Andrews, KY16 9TF UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00610-4']
221,32399267,Clinical efficacy and quality of life after transrectal natural orifice specimen extraction for the treatment of middle and upper rectal cancer.,"Background


Laparoscopic anterior resection with natural orifice specimen extraction (NOSE) avoids extra abdominal extraction incision during colorectal surgery. Some surgeons realized the benefits of NOSE on clinical efficacy. We compared the clinical efficacy of laparoscopic NOSE, laparoscopic non-NOSE and open surgery (OS) for short-term recovery and quality of life (QoL).
Methods


A single randomized controlled trial of NOSE for middle and upper rectal cancer between April 2014 and February 2018. Preoperative and postoperative clinical variables were analyzed and compared between the groups. Preoperative and 6 months postoperative QoL was assessed with the SF-36 QoL questionnaire.
Results


A total of 378 patients were enrolled, 334 patients randomly divided into NOSE group (n=104), non-NOSE group (n=119), OS group (n=111). The NOSE group was superior to the other two groups on the QoL after surgery. The NOSE group had the lowest postoperative VAS score between three groups. The postoperative time for bowel function recovery and the length of hospital stay was statistically significantly different among the three groups, with the NOSE group having the shortest time. The incidence of postoperative complications was lower in the NOSE group (12/104, 11.5%) than in the non-NOSE group (20/119, 16.8%), the difference was statistically significant. The Kaplan-Meier (K-M) survival curve showed no statistically significant difference in the disease-free survival (DFS) rate between the three groups.
Conclusions


Comparing NOSE to non-NOSE and OS, the NOSE had significantly better functional recovery and better QoL. The NOSE group had a significant lower surgical complication rate than the non-NOSE group.",2020,"The Kaplan-Meier (K-M) survival curve showed no statistically significant difference in the disease-free survival (DFS) rate between the three groups.
","['middle and upper rectal cancer', '378 patients were enrolled, 334 patients randomly divided into NOSE group (n=104), non-NOSE group (n=119), OS group (n=111', 'for middle and upper rectal cancer between April 2014 and February 2018']","['laparoscopic NOSE, laparoscopic non-NOSE and open surgery (OS', 'NOSE', 'transrectal natural orifice specimen extraction', '\n\n\nLaparoscopic anterior resection with natural orifice specimen extraction (NOSE']","['Clinical efficacy and quality of life', 'Kaplan-Meier (K-M) survival', 'functional recovery and better QoL', 'quality of life (QoL', 'incidence of postoperative complications', 'postoperative time for bowel function recovery and the length of hospital stay', 'lowest postoperative VAS score', 'SF-36 QoL questionnaire', 'surgical complication rate', 'disease-free survival (DFS) rate']","[{'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0205518', 'cui_str': 'Transrectal approach'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",378.0,0.0345761,"The Kaplan-Meier (K-M) survival curve showed no statistically significant difference in the disease-free survival (DFS) rate between the three groups.
","[{'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai 200120, China.'}, {'ForeName': 'Kai-Jing', 'Initials': 'KJ', 'LastName': 'Wang', 'Affiliation': 'Department of Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai 200120, China.'}, {'ForeName': 'Guy R', 'Initials': 'GR', 'LastName': 'Orangio', 'Affiliation': 'Department of Surgery, Louisiana State University, New Orleans, LA, USA.'}, {'ForeName': 'Jun-Yi', 'Initials': 'JY', 'LastName': 'Han', 'Affiliation': 'Department of Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai 200120, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Lu', 'Affiliation': 'Department of Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai 200120, China.'}, {'ForeName': 'Zhu-Qing', 'Initials': 'ZQ', 'LastName': 'Zhou', 'Affiliation': 'Department of Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai 200120, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Department of Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai 200120, China.'}, {'ForeName': 'Chuan-Gang', 'Initials': 'CG', 'LastName': 'Fu', 'Affiliation': 'Department of Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai 200120, China.'}]",Journal of gastrointestinal oncology,['10.21037/jgo.2020.03.05']
222,32399286,Weight Change and Its Association with Cardiometabolic Risk Markers in Overweight and Obese Women.,"Objectives


To examine the association of weight loss magnitude with changes in cardiometabolic risk markers in overweight and obese women from low socioeconomic areas engaged in a lifestyle intervention.
Methods


Analyses were performed on 243 women (mean body mass index 31.27 ± 4.14 kg/m 2 ) who completed a 12-month lifestyle intervention in low socioeconomic communities in Klang Valley, Malaysia. Analysis of covariance (ANCOVA) was used to compare changes of cardiometabolic risk factors across weight change categories (2% gain, ±2% maintain, >2 to <5% loss, and 5 to 20% loss) within intervention and control group.
Results


A graded association for changes in waist circumference, fasting insulin, and total cholesterol ( p =0.002, for all variables) across the weight change categories were observed within the intervention group at six months postintervention. Participants who lost 5 to 20% of weight had the greatest improvements in those risk markers (-5.67 cm CI: -7.98 to -3.36, -4.27  μ U/mL CI: -7.35, -1.19, and -0.59 mmol/L CI: -.99, -0.19, respectively) compared to those who did not. Those who lost >2% to <5% weight reduced more waist circumference (-4.24 cm CI: -5.44 to -3.04) and fasting insulin (-0.36  μ U/mL CI: -1.95 to 1.24) than those who maintained or gained weight. No significant association was detected in changes of risk markers across the weight change categories within the control group except for waist circumference and adiponectin.
Conclusion


Weight loss of >2 to <5% obtained through lifestyle intervention may represent a reasonable initial weight loss target for women in the low socioeconomic community as it led to improvements in selected risk markers, particularly of diabetes risk.",2020,"No significant association was detected in changes of risk markers across the weight change categories within the control group except for waist circumference and adiponectin.
","['Overweight and Obese Women', 'overweight and obese women from low socioeconomic areas engaged in a lifestyle intervention', '243 women (mean body mass index 31.27\u2009±\u20094.14\u2009kg/m 2 ) who completed a 12-month lifestyle intervention in low socioeconomic communities in Klang Valley, Malaysia']",['μ U/mL CI'],"['fasting insulin', 'waist circumference, fasting insulin, and total cholesterol', 'waist circumference', 'cardiometabolic risk markers']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0563004', 'cui_str': 'Valley'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}]","[{'cui': 'C0439340', 'cui_str': 'kU/L'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",243.0,0.0307575,"No significant association was detected in changes of risk markers across the weight change categories within the control group except for waist circumference and adiponectin.
","[{'ForeName': 'Liyana', 'Initials': 'L', 'LastName': 'Ahmad Zamri', 'Affiliation': 'Endocrine and Metabolic Unit, Institute for Medical Research, National Institutes of Health, Ministry of Health Malaysia, Setia Alam, 40170 Shah Alam, Selangor, Malaysia.'}, {'ForeName': 'Geeta', 'Initials': 'G', 'LastName': 'Appannah', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400 Serdang, Selangor, Malaysia.'}, {'ForeName': 'Siti Yazmin', 'Initials': 'SY', 'LastName': 'Zahari Sham', 'Affiliation': 'Department of Pathology, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400 Serdang, Selangor, Malaysia.'}, {'ForeName': 'Fazliana', 'Initials': 'F', 'LastName': 'Mansor', 'Affiliation': 'Endocrine and Metabolic Unit, Institute for Medical Research, National Institutes of Health, Ministry of Health Malaysia, Setia Alam, 40170 Shah Alam, Selangor, Malaysia.'}, {'ForeName': 'Rashidah', 'Initials': 'R', 'LastName': 'Ambak', 'Affiliation': 'Institute for Public Health, National Institutes of Health, Ministry of Health Malaysia, Setia Alam, 40170 Shah Alam, Selangor, Malaysia.'}, {'ForeName': 'Noor Safiza', 'Initials': 'NS', 'LastName': 'Mohd Nor', 'Affiliation': 'Allied Health Sciences Division, Ministry of Health Malaysia, 62050 Putrajaya, Malaysia.'}, {'ForeName': 'Tahir', 'Initials': 'T', 'LastName': 'Aris', 'Affiliation': 'Institute for Public Health, National Institutes of Health, Ministry of Health Malaysia, Setia Alam, 40170 Shah Alam, Selangor, Malaysia.'}]",Journal of obesity,['10.1155/2020/3198326']
223,32399295,Influence of 8-Week Aerobic Training on the Skin Microcirculation in Patients with Ischaemic Heart Disease.,"Materials and Methods


In the study, 48 men took part with a stabilized and pharmacologically controlled ischaemic disease. The participants were randomly divided into two groups with 24 people in each of them. The research group participated in an aerobic march training. The march was taking place 3 times a week for 30-40 minutes over a period of 8 weeks. In the time of training, the subjects did not practise any other physical activity for 8 weeks. The measurement of skin microcirculation was done by using the laser Doppler flowmeter estimating the values of regular flow and the reactions provoked in response to occlusion and temperature. Signal frequency was also analysed which was received by means of laser Doppler flowmetry in the range from 0.01 to 2 Hz during the regular flow.
Results


During the first measurement in relation to the initial values, a decrease in body mass was noted by 2.21 kg on average as well as reduction of systolic and diastolic pressure by 10.4 mmHg and 3.68 mmHg, respectively. The regular flow (RF) increased after the training by 2.21%. The provoked reactions were as follows: hyperemic (PRHmax): an increase occurred by 8.76% and hyperthermic (THmax): an increase occurred by 5.38%. The time needed to achieve PRHmax was reduced by 42% and to achieve THmax, by 22%. The heart rhythm and the signal strength of neurogenic rhythm decreased by approximately 8% and 24%, respectively. The signal strength of endothelial rhythm increased by 19%. In the second measurement, a recourse was noted in the values of indicators under investigation, which were assuming values close to the initial ones. In the control group, the measurement values did not change significantly.
Conclusions


8 weeks of systematic aerobic training provides a significant improvement of endothelium functioning, expressed by reactivity improvement in skin microcirculation in patients suffering from ischaemic heart disease. It points to aerobic training as a nonpharmacological effective cardioprotective factor. The improvement effects of skin vascular bed functioning in the group of patients with IHD are impermanent, and they disappear after the period in which patients did not exercise physical activity.",2020,"In the control group, the measurement values did not change significantly.
","['Patients with Ischaemic Heart Disease', 'patients suffering from ischaemic heart disease', '48 men took part with a stabilized and pharmacologically controlled ischaemic disease']","['aerobic training', 'systematic aerobic training', '8-Week Aerobic Training', 'aerobic march training']","['body mass', 'time needed to achieve PRHmax', 'systolic and diastolic pressure', 'regular flow (RF', 'signal strength of endothelial rhythm', 'Signal frequency', 'Skin Microcirculation', 'endothelium functioning', 'heart rhythm and the signal strength of neurogenic rhythm', 'skin microcirculation', 'skin vascular bed functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0232187', 'cui_str': 'Cardiac rhythm type'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",48.0,0.0151882,"In the control group, the measurement values did not change significantly.
","[{'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Szyguła', 'Affiliation': 'The Witelon State University of Applied Sciences in Legnica, Faculty of Health Science and Physical Education, Legnica, Poland.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Wierzbicka', 'Affiliation': 'The Witelon State University of Applied Sciences in Legnica, Faculty of Health Science and Physical Education, Legnica, Poland.'}, {'ForeName': 'Grażyna', 'Initials': 'G', 'LastName': 'Sondel', 'Affiliation': 'The Witelon State University of Applied Sciences in Legnica, Faculty of Health Science and Physical Education, Legnica, Poland.'}]",Journal of aging research,['10.1155/2020/4602067']
224,32325038,"Safety and immunogenicity of a candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine: a dose-escalation, open-label, non-randomised, uncontrolled, phase 1 trial.","BACKGROUND


Cases of Middle East respiratory syndrome coronavirus (MERS-CoV) infection continue to rise in the Arabian Peninsula 7 years after it was first described in Saudi Arabia. MERS-CoV poses a significant risk to public health security because of an absence of currently available effective countermeasures. We aimed to assess the safety and immunogenicity of the candidate simian adenovirus-vectored vaccine expressing the full-length spike surface glycoprotein, ChAdOx1 MERS, in humans.
METHODS


This dose-escalation, open-label, non-randomised, uncontrolled, phase 1 trial was done at the Centre for Clinical Vaccinology and Tropical Medicine (Oxford, UK) and included healthy people aged 18-50 years with negative pre-vaccination tests for HIV antibodies, hepatitis B surface antigen, and hepatitis C antibodies (and a negative urinary pregnancy test for women). Participants received a single intramuscular injection of ChAdOx1 MERS at three different doses: the low-dose group received 5 × 10 9  viral particles, the intermediate-dose group received 2·5 × 10 10  viral particles, and the high-dose group received 5 × 10 10  viral particles. The primary objective was to assess safety and tolerability of ChAdOx1 MERS, measured by the occurrence of solicited, unsolicited, and serious adverse events after vaccination. The secondary objective was to assess the cellular and humoral immunogenicity of ChAdOx1 MERS, measured by interferon-γ-linked enzyme-linked immunospot, ELISA, and virus neutralising assays after vaccination. Participants were followed up for up to 12 months. This study is registered with ClinicalTrials.gov, NCT03399578.
FINDINGS


Between March 14 and Aug 15, 2018, 24 participants were enrolled: six were assigned to the low-dose group, nine to the intermediate-dose group, and nine to the high-dose group. All participants were available for follow-up at 6 months, but five (one in the low-dose group, one in the intermediate-dose group, and three in the high-dose group) were lost to follow-up at 12 months. A single dose of ChAdOx1 MERS was safe at doses up to 5 × 10 10  viral particles with no vaccine-related serious adverse events reported by 12 months. One serious adverse event reported was deemed to be not related to ChAdOx1 MERS. 92 (74% [95% CI 66-81]) of 124 solicited adverse events were mild, 31 (25% [18-33]) were moderate, and all were self-limiting. Unsolicited adverse events in the 28 days following vaccination considered to be possibly, probably, or definitely related to ChAdOx1 MERS were predominantly mild in nature and resolved within the follow-up period of 12 months. The proportion of moderate and severe adverse events was significantly higher in the high-dose group than in the intermediate-dose group (relative risk 5·83 [95% CI 2·11-17·42], p<0·0001) Laboratory adverse events considered to be at least possibly related to the study intervention were self-limiting and predominantly mild in severity. A significant increase from baseline in T-cell (p<0·003) and IgG (p<0·0001) responses to the MERS-CoV spike antigen was observed at all doses. Neutralising antibodies against live MERS-CoV were observed in four (44% [95% CI 19-73]) of nine participants in the high-dose group 28 days after vaccination, and 19 (79% [58-93]) of 24 participants had antibodies capable of neutralisation in a pseudotyped virus neutralisation assay.
INTERPRETATION


ChAdOx1 MERS was safe and well tolerated at all tested doses. A single dose was able to elicit both humoral and cellular responses against MERS-CoV. The results of this first-in-human clinical trial support clinical development progression into field phase 1b and 2 trials.
FUNDING


UK Department of Health and Social Care, using UK Aid funding, managed by the UK National Institute for Health Research.",2020,"Neutralising antibodies against live MERS-CoV were observed in four (44% [95% CI 19-73]) of nine participants in the high-dose group 28 days after vaccination, and 19 (79% [58-93]) of 24 participants had antibodies capable of neutralisation in a pseudotyped virus neutralisation assay.
","['healthy people aged 18-50 years with negative pre-vaccination tests for HIV antibodies, hepatitis B surface antigen, and hepatitis C antibodies (and a negative urinary pregnancy test for women', '24 participants were enrolled: six', 'Between March 14 and Aug 15, 2018', 'humans']","['single intramuscular injection of ChAdOx1 MERS', 'low-dose group received 5\u2008×\u200810 9  viral particles, the intermediate-dose group received 2·5\u2008×\u200810 10  viral particles, and the high-dose group received 5\u2008×\u200810 10  viral particles', 'candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine', 'ChAdOx1 MERS']","['Unsolicited adverse events', 'cellular and humoral immunogenicity of ChAdOx1 MERS, measured by interferon-γ-linked enzyme-linked immunospot, ELISA, and virus neutralising assays', 'Safety and immunogenicity', 'safety and tolerability of ChAdOx1 MERS', 'serious adverse events', 'safe and well tolerated', 'safety and immunogenicity', 'Neutralising antibodies against live MERS-CoV', 'T-cell (p<0·003) and IgG (p<0·0001) responses to the MERS-CoV spike antigen', 'occurrence of solicited, unsolicited, and serious adverse events', 'proportion of moderate and severe adverse events']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019683', 'cui_str': 'Human immunodeficiency virus antibody'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0166049', 'cui_str': 'Antibody to hepatitis C virus'}, {'cui': 'C0032976', 'cui_str': 'Pregnancy detection examination'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0065973', 'cui_str': 'methanol extraction residue (MER) tubercle bacillus fraction'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042760', 'cui_str': 'Virion'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0065973', 'cui_str': 'methanol extraction residue (MER) tubercle bacillus fraction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",24.0,0.0881364,"Neutralising antibodies against live MERS-CoV were observed in four (44% [95% CI 19-73]) of nine participants in the high-dose group 28 days after vaccination, and 19 (79% [58-93]) of 24 participants had antibodies capable of neutralisation in a pseudotyped virus neutralisation assay.
","[{'ForeName': 'Pedro M', 'Initials': 'PM', 'LastName': 'Folegatti', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mustapha', 'Initials': 'M', 'LastName': 'Bittaye', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Flaxman', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Fernando Ramos', 'Initials': 'FR', 'LastName': 'Lopez', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Bellamy', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kupke', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mair', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Makinson', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sheridan', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Cornelius', 'Initials': 'C', 'LastName': 'Rohde', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Halwe', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Jeong', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Young-Shin', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Jae-Ouk', 'Initials': 'JO', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Manki', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Boyd', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nguyen', 'Initials': 'N', 'LastName': 'Tran', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Silman', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Poulton', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mehreen', 'Initials': 'M', 'LastName': 'Datoo', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Marshal', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Yrene', 'Initials': 'Y', 'LastName': 'Themistocleous', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Lawrie', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Roberts', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Berrie', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lambe', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Ewer', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gilbert', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK. Electronic address: sarah.gilbert@ndm.ox.ac.uk.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30160-2']
225,32396700,Integrating oral PrEP delivery among African women in a large HIV endpoint-driven clinical trial.,"INTRODUCTION


Global guidelines emphasize the ethical obligation of investigators to help participants in HIV-endpoint trials reduce HIV risk by offering an optimal HIV prevention package. Oral pre-exposure prophylaxis (PrEP) has increasingly become part of state-of-the-art HIV prevention. Here we describe the process of integrating oral PrEP delivery into the HIV prevention package of the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial.
METHODS


ECHO was an open-label randomized clinical trial that compared HIV incidence among women randomized to one of three effective contraceptives. In total, 7830 women aged 16 to 35 years from 12 sites in four African countries (Eswatini, Kenya, South Africa and Zambia) were enrolled and followed for 12 to 18 months, from 2015 to 2018. Part-way through the course of the trial, oral PrEP was provided to study participants either off-site via referral or on site via trained trial staff. PrEP uptake was compared between different contraceptive users using Chi-squared tests or t-tests. HIV seroincidence rates were compared between participants who never versus ever initiated PrEP using exact Poisson regression.
RESULTS


PrEP access in ECHO began through public availability in Kenya in May 2017 and was available at all sites by June 2018. When PrEP became available, 3626 (46.3%) eligible women were still in follow-up in the study, and of these, 622 (17.2%) initiated PrEP. Women initiating PrEP were slightly older; more likely to be unmarried, not living with their partner, having multiple partners; and less likely to be earning their own income and receiving financial support from partners (all p < 0.05). PrEP initiation did not differ across study randomized groups (p = 0.7). Two-thirds of PrEP users were continuing PrEP at study exit.
CONCLUSIONS


There is a need for improved HIV prevention services in clinical trials with HIV endpoints, especially trials among African women. PrEP as a component of a comprehensive HIV prevention package provided to women in a large clinical trial is practical and feasible. Provision of PrEP within clinical trials with HIV outcomes should be standard of prevention.",2020,PrEP initiation did not differ across study randomized groups (p = 0.7).,"['participants either off-site via referral or on site via trained trial staff', 'African women', '7830 women aged 16 to 35\xa0years from 12 sites in four African countries (Eswatini, Kenya, South Africa and Zambia) were enrolled and followed for 12 to 18\xa0months, from 2015 to 2018', 'African women in a large HIV endpoint-driven clinical trial']",['Oral pre-exposure prophylaxis (PrEP'],"['PrEP uptake', 'HIV seroincidence rates']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0454695', 'cui_str': 'African country'}, {'cui': 'C0038983', 'cui_str': 'Swaziland'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0004379', 'cui_str': 'Driving'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",7830.0,0.194832,PrEP initiation did not differ across study randomized groups (p = 0.7).,"[{'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Beesham', 'Affiliation': 'MatCH Research Unit (MRU), Faculty of Health Sciences, University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Julia D', 'Initials': 'JD', 'LastName': 'Welch', 'Affiliation': 'FHI 360, Durham, NC, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Heffron', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Pleaner', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Kidoguchi', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Thesla', 'Initials': 'T', 'LastName': 'Palanee-Phillips', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Khatija', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': 'Setshaba Research Centre, Tshwane, South Africa.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Baron', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Louw', 'Affiliation': 'Madibeng Centre for Research, Brits, South Africa.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Mastro', 'Affiliation': 'FHI 360, Durham, NC, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Smit', 'Affiliation': 'MatCH Research Unit (MRU), Faculty of Health Sciences, University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Joanne R', 'Initials': 'JR', 'LastName': 'Batting', 'Affiliation': 'Effective Care Research Unit (ECRU), Fort Hare and Eastern Cape Department of Health, Universities of the Witwatersrand, East London, South Africa.'}, {'ForeName': 'Mookho', 'Initials': 'M', 'LastName': 'Malahleha', 'Affiliation': 'Setshaba Research Centre, Tshwane, South Africa.'}, {'ForeName': 'Veronique C', 'Initials': 'VC', 'LastName': 'Bailey', 'Affiliation': 'Setshaba Research Centre, Tshwane, South Africa.'}, {'ForeName': 'Mags', 'Initials': 'M', 'LastName': 'Beksinska', 'Affiliation': 'MatCH Research Unit (MRU), Faculty of Health Sciences, University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Donnell', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the International AIDS Society,['10.1002/jia2.25491']
226,32334632,"The Balanced Opioid Initiative: protocol for a clustered, sequential, multiple-assignment randomized trial to construct an adaptive implementation strategy to improve guideline-concordant opioid prescribing in primary care.","BACKGROUND


Rates of opioid prescribing tripled in the USA between 1999 and 2015 and were associated with significant increases in opioid misuse and overdose death. Roughly half of all opioids are prescribed in primary care. Although clinical guidelines describe recommended opioid prescribing practices, implementing these guidelines in a way that balances safety and effectiveness vs. risk remains a challenge. The literature offers little help about which implementation strategies work best in different clinical settings or how strategies could be tailored to optimize their effectiveness in different contexts. Systems consultation consists of (1) educational/engagement meetings with audit and feedback reports, (2) practice facilitation, and (3) prescriber peer consulting. The study is designed to discover the most cost-effective sequence and combination of strategies for improving opioid prescribing practices in diverse primary care clinics.
METHODS/DESIGN


The study is a hybrid type 3 clustered, sequential, multiple-assignment randomized trial (SMART) that randomizes clinics from two health systems at two points, months 3 and 9, of a 21-month intervention. Clinics are provided one of four sequences of implementation strategies: a condition consisting of educational/engagement meetings and audit and feedback alone (EM/AF), EM/AF plus practice facilitation (PF), EM/AF + prescriber peer consulting (PPC), and EM/AF + PF + PPC. The study's primary outcome is morphine-milligram equivalent (MME) dose by prescribing clinicians within clinics. The study's primary aim is the comparison of EM/AF + PF + PPC versus EM/AF alone on change in MME from month 3 to month 21. The secondary aim is to derive cost estimates for each of the four sequences and compare them. The exploratory aim is to examine four tailoring variables that can be used to construct an adaptive implementation strategy to meet the needs of different primary care clinics.
DISCUSSION


Systems consultation is a practical blend of implementation strategies used in this case to improve opioid prescribing practices in primary care. The blend offers a range of strategies in sequences from minimally to substantially intensive. The results of this study promise to help us understand how to cost effectively improve the implementation of evidence-based practices.
TRIAL REGISTRATION


NCT04044521 (ClinicalTrials.gov). Registered 05 August 2019.",2020,"BACKGROUND


Rates of opioid prescribing tripled in the USA between 1999 and 2015 and were associated with significant increases in opioid misuse and overdose death.","['primary care', 'diverse primary care clinics']","['EM/AF + PF + PPC versus EM/AF alone', 'educational/engagement meetings and audit and feedback alone (EM/AF), EM/AF plus practice facilitation (PF), EM/AF + prescriber peer consulting (PPC), and EM/AF + PF + PPC']","['opioid misuse and overdose death', 'morphine-milligram equivalent (MME) dose by prescribing clinicians within clinics']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]",,0.0591709,"BACKGROUND


Rates of opioid prescribing tripled in the USA between 1999 and 2015 and were associated with significant increases in opioid misuse and overdose death.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Quanbeck', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin-Madison, 800 University Bay Drive, Suite 210, Madison, WI, 53705-2278, USA. arquanbe@wisc.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Almirall', 'Affiliation': 'Department of Statistics and Institute for Social Research, University of Michigan, 2448 Institute for Social Research, 426 Thompson St., Ann Arbor, MI, 48104-2321, USA.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Jacobson', 'Affiliation': 'Institute for Clinical and Translational Research and School of Nursing, University of Wisconsin, Madison, 5130 Signe Skott Cooper Hall, 701 Highland Ave, Madison, WI, 53705-2202, USA.'}, {'ForeName': 'Randall T', 'Initials': 'RT', 'LastName': 'Brown', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin-Madison, 1100 Delaplaine Ct, Madison, WI, 53705-1840, USA.'}, {'ForeName': 'Jillian K', 'Initials': 'JK', 'LastName': 'Landeck', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin-Madison, 1100 Delaplaine Ct, Madison, WI, 53705-1840, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Madden', 'Affiliation': 'APT Foundation, 1 Long Wharf Drive, Suite 321, New Haven, CT, 06511-5991, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': 'Bellin Health Systems, Inc., 744 S. Webster Ave, Green Bay, WI, 54305, USA.'}, {'ForeName': 'Brienna M F', 'Initials': 'BMF', 'LastName': 'Deyo', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin-Madison, 1100 Delaplaine Ct, Madison, WI, 53705-1840, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Forward Data Analytic Services, LLC, 6700 Cross Country Road, Verona, WI, 53593, USA.'}, {'ForeName': 'Roberta A', 'Initials': 'RA', 'LastName': 'Johnson', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin-Madison, 800 University Bay Drive, Suite 210, Madison, WI, 53705-2278, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Schumacher', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin-Madison, 800 University Bay Drive, Suite 210, Madison, WI, 53705-2278, USA.'}]",Implementation science : IS,['10.1186/s13012-020-00990-4']
227,32335159,Supplementation with a putative calorie restriction mimetic micronutrient blend increases glutathione concentrations and improves neuroenergetics in brain of healthy middle-aged men and women.,"BACKGROUND


Caloric restriction (CR) without micronutrient deficiency has been shown to increase both lifespan and healthspan. In animals, CR has been demonstrated to increase glutathione (GSH), a neuroprotective antioxidant, in the brain and preserve brain mitochondrial function by altering neuroenergetics. In humans it has been associated with improvements in mood states and cognitive function. However, most CR studies have employed a 30-60% reduction in calories which is likely too stringent for most people to adhere to long-term. Thus, there is an unmet need for nutritional supplements which can mimic the biological effects of CR, without the need for calorie limitations.
AIM


The purpose of the present randomized, placebo-controlled clinical trial was to use Proton ( 1 H) Magnetic Resonance Spectroscopic (MRS) measurements to determine non-invasively whether a blend of micronutrients, a putative CR mimetic, positively modulates metabolites related to neuroprotection and neuroenergetics in the brain.
METHODS


Healthy middle-aged men and women (N = 63 [33 women]; age: 40-60 years) were randomized in a double-blind manner to 6 weeks supplementation with either the putative CR mimetic or placebo. At baseline and 6 weeks, subjects underwent MRS at 3 T to investigate changes in brain chemistry, including the neurometabolites: GSH, Glutamate (Glu), Glutamine (Gln) and N-Acetylaspartate (NAA).
RESULTS


GSH, a marker of antioxidant and cellular redox status, increased in the brain of participants in the supplement group. The supplement group also showed an increase in the Glu/Gln ratio, a marker of excitatory neurotransmission and bioenergetics. A trend for an increase in NAA/H 2 O, a marker of neuronal integrity, was observed in females in the supplement group.
CONCLUSIONS


The present study reveals that 6-weeks daily supplementation with a micronutrient blend elicits positive changes in brain neurochemistry. This is the first study to demonstrate that a putative CR mimetic increases brain GSH concentrations and improves neuroprotection and neuroenergetics in the brain of healthy humans. This study was registered at www.clinicaltrials.gov as NCT02439983.",2020,"A trend for an increase in NAA/H 2 O, a marker of neuronal integrity, was observed in females in the supplement group.
","['Healthy middle-aged men and women (N\u202f=\u202f63 [33 women]; age: 40-60 years', 'healthy middle-aged men and women', 'healthy humans']","['putative CR mimetic', 'putative CR mimetic or placebo', 'neurometabolites: GSH, Glutamate (Glu), Glutamine (Gln) and N-Acetylaspartate (NAA', 'Proton ( 1 H) Magnetic Resonance Spectroscopic (MRS', 'placebo']","['marker of antioxidant and cellular redox status', 'NAA/H 2 O, a marker of neuronal integrity', 'brain GSH concentrations', 'glutathione concentrations', 'glutathione (GSH', 'Glu/Gln ratio, a marker of excitatory neurotransmission and bioenergetics']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0067684', 'cui_str': 'N-acetyl-L-aspartate'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0067684', 'cui_str': 'N-acetyl-L-aspartate'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0027793', 'cui_str': 'Synaptic transmission'}, {'cui': 'C0005486', 'cui_str': 'Bioenergetics'}]",,0.190371,"A trend for an increase in NAA/H 2 O, a marker of neuronal integrity, was observed in females in the supplement group.
","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Mastaloudis', 'Affiliation': 'Pharmanex Research, NSE Products, Inc., Provo, UT, USA.'}, {'ForeName': 'Chandni', 'Initials': 'C', 'LastName': 'Sheth', 'Affiliation': 'Department of Psychiatry, University of Utah School of Medicine, Salt Lake City, UT, USA; Diagnostic Neuroimaging, University of Utah, Salt Lake City, UT, USA. Electronic address: chandni.sheth@utah.edu.'}, {'ForeName': 'Shelly N', 'Initials': 'SN', 'LastName': 'Hester', 'Affiliation': 'Pharmanex Research, NSE Products, Inc., Provo, UT, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Wood', 'Affiliation': 'Pharmanex Research, NSE Products, Inc., Provo, UT, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Prescot', 'Affiliation': 'Department of Radiology, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'McGlade', 'Affiliation': 'Department of Psychiatry, University of Utah School of Medicine, Salt Lake City, UT, USA; Diagnostic Neuroimaging, University of Utah, Salt Lake City, UT, USA; George E. Wahlen Department of Veterans Affairs Medical Center, VA VISN 19 Mental Illness Research, Education and Clinical Center (MIRREC), Salt Lake City, UT, USA.'}, {'ForeName': 'Perry F', 'Initials': 'PF', 'LastName': 'Renshaw', 'Affiliation': 'Department of Psychiatry, University of Utah School of Medicine, Salt Lake City, UT, USA; Diagnostic Neuroimaging, University of Utah, Salt Lake City, UT, USA; George E. Wahlen Department of Veterans Affairs Medical Center, VA VISN 19 Mental Illness Research, Education and Clinical Center (MIRREC), Salt Lake City, UT, USA.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Yurgelun-Todd', 'Affiliation': 'Department of Psychiatry, University of Utah School of Medicine, Salt Lake City, UT, USA; Diagnostic Neuroimaging, University of Utah, Salt Lake City, UT, USA; George E. Wahlen Department of Veterans Affairs Medical Center, VA VISN 19 Mental Illness Research, Education and Clinical Center (MIRREC), Salt Lake City, UT, USA.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.04.017']
228,32335288,The 'Take a Break' game: Randomized trial protocol for a technology-assisted brief abstinence experience designed to engage lower-motivated smokers.,"BACKGROUND


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


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


Take a Break is an innovative approach to engage those not prepared for a quit attempt. Take a Break provides motivation phase smokers with tools and a brief experience to prepare them for a quit attempt, filling a gap in tobacco cessation support and current research.",2020,"Primary outcomes include number of days abstinent during the challenge, change in patient-reported self-efficacy after the challenge, time to first quit attempt following the challenge, and 7-day point prevalent smoking cessation at six months.
","['engage lower-motivated smokers', 'smokers not ready to quit']","['Motivational Messages, 2) text message Challenge Quizzes, 3) Goal-setting with tobacco treatment specialist, 4) Coping Mini-Games apps, and 5) Recognition and Rewards for participation during a 3-week challenge', 'Nicotine Replacement Therapy (NRT) sampling and daily smoking assessment text messages']","['number of days abstinent during the challenge, change in patient-reported self-efficacy after the challenge, time to first quit attempt following the challenge, and 7-day point prevalent smoking cessation']","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3853073', 'cui_str': 'Smoking assessment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]",,0.0313065,"Primary outcomes include number of days abstinent during the challenge, change in patient-reported self-efficacy after the challenge, time to first quit attempt following the challenge, and 7-day point prevalent smoking cessation at six months.
","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Amante', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America. Electronic address: daniel.amante@umassmed.edu.'}, {'ForeName': 'Amanda C', 'Initials': 'AC', 'LastName': 'Blok', 'Affiliation': 'VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, United States Department of Veterans Affairs, Ann Arbor, MI, United States of America; Systems, Populations and Leadership Department, School of Nursing, University of Michigan, Ann Arbor, MI, United States of America.'}, {'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Nagawa', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Jessica G', 'Initials': 'JG', 'LastName': 'Wijesundara', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Jeroan J', 'Initials': 'JJ', 'LastName': 'Allison', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Sharina D', 'Initials': 'SD', 'LastName': 'Person', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Morley', 'Affiliation': 'Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States of America; Feinstein Institute for Medical Research, Manhasset, NY, United States of America.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Conigliaro', 'Affiliation': 'Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States of America; Feinstein Institute for Medical Research, Manhasset, NY, United States of America.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Mattocks', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America; VA Central Western Massachusetts Healthcare System, Leeds, MA, United States of America.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Garber', 'Affiliation': 'Reliant Medical Group, Worcester, MA, United States of America.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Houston', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America; Department of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, NC, United States of America.'}, {'ForeName': 'Rajani S', 'Initials': 'RS', 'LastName': 'Sadasivam', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106002']
229,32289518,Effects of supervised high-intensity resistance and impact training or machine-based isometric training on regional bone geometry and strength in middle-aged and older men with low bone mass: The LIFTMOR-M semi-randomised controlled trial.,"INTRODUCTION


Few data exist on the effects of bone-targeted exercise on geometric and biomechanical indices of bone strength in men. The Lifting Intervention For Training Muscle and Osteoporosis Rehabilitation for Men (LIFTMOR-M) trial was designed to compare the efficacy and safety of two novel, supervised, twice-weekly, high-intensity exercise programs in middle-aged and older men with osteopenia and osteoporosis on musculoskeletal health and risk factors related to falls and fractures. The current report includes secondary outcomes of the LIFTMOR-M exercise intervention trial.
PURPOSE


Our goal was to determine the effects of two supervised, twice-weekly, high-intensity exercise programs on bone geometry and strength of the proximal femur, and distal and proximal sites of the tibia and radius in middle-aged and older men with osteopenia and osteoporosis.
METHODS


Generally-healthy men (≥45 years), with low lumbar spine (LS) and/or proximal femur areal bone mineral density (aBMD), were recruited from the community. Eligible participants were randomised to either eight months of twice-weekly supervised high-intensity progressive resistance and impact training (HiRIT) or supervised machine-based isometric axial compression (IAC) exercise training. Intervention group outcomes were compared at baseline and eight months with a matched but non-randomised control group (CON) who self-selected to usual activities. DXA scans (Medix DR, Medilink, France) of the skeletally non-dominant proximal femur were analysed using 3D hip software (DMS Group, France) to derive femoral neck (FN) and total hip (TH) bone mineral content (BMC), volume, and volumetric bone mineral density (vBMD) for total, trabecular and cortical bone compartments. Total FN cortical thickness was determined as well as anterior, posterior, lateral and medial subregions. pQCT scans (XCT-3000, Stratec, Germany) of the 4 and 38% sites of the tibia, and 4 and 66% sites of the radius were conducted to determine a range of geometric and bone structural strength indices. Intervention effects were examined using univariate ANCOVA of percent change, and repeated measures ANCOVA of raw baseline and follow-up data, controlling for initial values, using intention-to-treat and per-protocol approaches.
RESULTS


Ninety-three men (67.1 ± 7.5 yrs, 175.2 ± 6.7 cm, 82.1 ± 11.6 kg, 26.7 ± 3.5 kg/m 2 ) with lower than average aBMD (LS T-score -0.06 ± 1.04, FN T-score -1.58 ± 0.58, TH T-score -1.00 ± 0.58) were recruited, and designated CON (n = 26) or randomised to HiRIT (n = 34) or IAC (n = 33). Compliance to the supervised exercise programs did not differ (HiRIT 77.8 ± 16.6% versus IAC 78.5 ± 14.8%, p = 0.872). HiRIT improved medial FN cortical thickness compared with CON (5.6 ± 1.7% versus -0.1 ± 1.9%, p = 0.028) and IAC (5.6 ± 1.7% versus 0.7 ± 1.7%, p = 0.044). Distal tibia total BMC, vBMD, area and bone strength index, and trabecular BMC and bone strength index all declined for CON compared with maintenance for both HiRIT and IAC (all p < 0.05). HiRIT maintained distal tibia trabecular area compared with a loss in CON (0.2 ± 0.5% versus -1.6 ± 0.5%, p = 0.013). HiRIT and IAC maintained distal radius total BMC compared with loss in CON (-0.1 ± 0.7% versus -3.7 ± 0.8%, p = 0.001; 1.3 ± 0.7% versus -3.7 ± 0.8%, p < 0.001, respectively). HiRIT and IAC maintained distal radius total bone strength index compared with loss in CON (1.4 ± 1.4% versus -6.0 ± 1.6%, p = 0.001; 0.2 ± 1.3% versus -6.0 ± 1.6%, p = 0.004, respectively). HiRIT reduced proximal radius cortical area compared with CON (-3.1 ± 1.0% versus 1.1 ± 1.2%, p = 0.011) and IAC (-3.1 ± 1.0% versus -0.2 ± 1.0%, p = 0.042). No between-group differences were detected in any pQCT-derived bone outcome at the diaphyseal tibia 38% site.
CONCLUSION


Findings indicate that supervised HiRIT provides a positive stimulus to cortical bone at the medial FN compared with supervised IAC exercise, and both HiRIT and IAC preserve bone strength at the distal tibia and distal radius. These effects may translate into a reduced risk of lower and upper extremity fracture in middle-aged and older men with low bone mass.",2020,"No between-group differences were detected in any pQCT-derived bone outcome at the diaphyseal tibia 38% site.
","['middle-aged and older men with osteopenia and osteoporosis', 'Eligible participants', 'middle-aged and older men with low bone mass', 'Ninety-three men (67.1\u202f±\u202f7.5\u202fyrs, 175.2\u202f±\u202f6.7\u202fcm, 82.1\u202f±\u202f11.6\u202fkg, 26.7\u202f±\u202f3.5\u202fkg/m 2 ) with lower than average aBMD (LS T-score -0.06\u202f±\u202f1.04, FN T-score -1.58\u202f±\u202f0.58, TH T-score -1.00\u202f±\u202f0.58) were recruited, and designated CON (n\u202f=\u202f26) or randomised to', 'men', 'Generally-healthy men (≥45\u202fyears), with low lumbar spine (LS) and/or proximal femur areal bone mineral density (aBMD), were recruited from the community', 'middle-aged and older men with osteopenia and osteoporosis on musculoskeletal health and risk factors related to falls and fractures']","['IAC', 'high-intensity exercise programs', 'Lifting Intervention For Training Muscle and Osteoporosis Rehabilitation', 'supervised high-intensity resistance and impact training or machine-based isometric training', 'HiRIT', 'twice-weekly supervised high-intensity progressive resistance and impact training (HiRIT) or supervised machine-based isometric axial compression (IAC) exercise training']","['HiRIT maintained distal tibia trabecular area', 'pQCT-derived bone outcome', 'femoral neck (FN) and total hip (TH) bone mineral content (BMC), volume, and volumetric bone mineral density (vBMD) for total, trabecular and cortical bone compartments', 'Total FN cortical thickness', 'Distal tibia total BMC, vBMD, area and bone strength index, and trabecular BMC and bone strength index', 'DXA scans (Medix DR, Medilink, France', 'HiRIT and IAC maintained distal radius total BMC', 'HiRIT and IAC maintained distal radius total bone strength index', 'efficacy and safety', 'regional bone geometry and strength', 'medial FN cortical thickness', 'HiRIT reduced proximal radius cortical area']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C5191362', 'cui_str': '1.04'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C4517463', 'cui_str': '0.58'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0588200', 'cui_str': 'Bone structure of distal tibia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0222652', 'cui_str': 'Cortex of bone'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0449829', 'cui_str': 'Geometry'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0588205', 'cui_str': 'Bone structure of proximal radius'}]",93.0,0.0493938,"No between-group differences were detected in any pQCT-derived bone outcome at the diaphyseal tibia 38% site.
","[{'ForeName': 'Amy T', 'Initials': 'AT', 'LastName': 'Harding', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Weeks', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Watson', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Weis', 'Affiliation': 'The Bone Clinic, Brisbane, Queensland, Australia.'}, {'ForeName': 'Belinda R', 'Initials': 'BR', 'LastName': 'Beck', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia; The Bone Clinic, Brisbane, Queensland, Australia. Electronic address: b.beck@griffith.edu.au.'}]",Bone,['10.1016/j.bone.2020.115362']
230,32311521,"A Commentary on the article: Visualising improved peritoneal perfusion at lower intra-abdominal pressure by fluorescent imaging during laparoscopic surgery: A randomised controlled study, Int J Surg. 2020 Mar 17. pii: S1743-9191(20)30231-4. doi: 10.1016/j.ijsu.2020.03.019.",,2020,,['pii'],['fluorescent imaging during laparoscopic surgery'],['peritoneal perfusion'],"[{'cui': 'C2983694', 'cui_str': 'Personally Identifiable Information'}]","[{'cui': 'C0303920', 'cui_str': 'Fluorescent stain'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",,0.0758544,,"[{'ForeName': 'Faramarz', 'Initials': 'F', 'LastName': 'Karimian', 'Affiliation': 'Tehran University of Medical Sciences-TUMS, Iran. Electronic address: faramarz.karimian@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.03.074']
231,32315769,"Commentary on ""Visualising improved peritoneal perfusion at lower intra-abdominal pressure by fluorescent imaging during laparoscopic surgery: A randomised controlled study"".",,2020,,[],['Visualising improved peritoneal perfusion at lower intra-abdominal pressure by fluorescent imaging during laparoscopic surgery'],[],[],"[{'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent stain'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]",[],,0.158978,,"[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'von Bechtolsheim', 'Affiliation': 'Department of Visceral, Thoracic- and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University Dresden, Fetscherstraße 74, 01307, Dresden, Germany. Electronic address: felix.bechtolsheim@uniklinikum-dresden.de.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Distler', 'Affiliation': 'Department of Visceral, Thoracic- and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University Dresden, Fetscherstraße 74, 01307, Dresden, Germany.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.03.086']
232,32315954,"Screening for oral cancer: Future prospects, research and policy development for Asia.","Although the incidence of oral cavity cancer is high among low and middle income countries in Asia where the risk habits (tobacco smoking, tobacco chewing and betel quid use) are common, the benefits for introducing oral cancer screening for the whole population in these countries still remains controversial. It is disappointing, but not surprising that many of studies, without control arms, could not provide a clear answer as to whether screening is effective in reducing mortality or combating rising incidence trends. Only one Indian study that reported a randomized controlled trial (RCT) elucidated that mass screening for high risk groups could significantly reduce the cancer mortality or down-stage cancers detected by screening. Several professional organizations that considered any potential benefits of oral cancer screening remain unconvinced that the current knowledge on its natural history, available tests and interventions to treat potentially malignant disorders satisfy the desirable criteria to recommend organized screening for oral cancer. In this review we discuss advantages and disadvantages for oral cancer screening particularly with reference to high incidence countries in Asia. If screening is undertaken, we propose that it is targeted to high risk groups and to combine screening with education on risky life-styles so that overall incidence can be reduced in the future. Further research on increasing public awarenes and impact of professional education such as e-learning to reduce diagnostic delays, studies on the natural history of oral potentially malignant disorders and cancer, comprehensive tobacco and areca nut cessation programs, developing tools to identify high-risk individuals and high-risk lesions are proposed.",2020,"Several professional organizations that considered any potential benefits of oral cancer screening remain unconvinced that the current knowledge on its natural history, available tests and interventions to treat potentially malignant disorders satisfy the desirable criteria to recommend organized screening for oral cancer.",['oral cancer'],[],['cancer mortality'],"[{'cui': 'C0153381', 'cui_str': 'Malignant tumor of oral cavity'}]",[],"[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0484795,"Several professional organizations that considered any potential benefits of oral cancer screening remain unconvinced that the current knowledge on its natural history, available tests and interventions to treat potentially malignant disorders satisfy the desirable criteria to recommend organized screening for oral cancer.","[{'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Nagao', 'Affiliation': 'Department of Maxillofacial Surgery School of Dentistry, Aichi Gakuin University, Nagoya, Japan. Electronic address: tnagao@dpc.agu.ac.jp.'}, {'ForeName': 'Saman', 'Initials': 'S', 'LastName': 'Warnakulasuriya', 'Affiliation': ""Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London, WHO Collaborating Centre for Oral Cancer, UK.""}]",Oral oncology,['10.1016/j.oraloncology.2020.104632']
233,32325373,"Safety, tolerability, pharmacokinetics, and pharmacodynamics of macimorelin in healthy adults: Results of a single-dose, randomized controlled study.","OBJECTIVE


Macimorelin is an orally active ghrelin receptor agonist indicated for the diagnosis of adult growth hormone (GH) deficiency in the United States. This phase 1 study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of macimorelin (including a supratherapeutic dose to be used in a thorough QT trial) in healthy adults.
DESIGN


Participants were randomized to receive macimorelin 0.5, 1.0, or 2.0 mg/kg or placebo in 1 of 3 sequential ascending-dose cohorts. Blood samples for pharmacokinetic and pharmacodynamic assays were collected pre-dose and at specified time points over a 24-h period. Pharmacokinetic parameters assessed included area under the concentration-time curve (AUC), maximum concentration (C max ) of macimorelin in plasma, time to C max  (t max ), and terminal elimination half-life (t 1/2 ). Pharmacodynamic assessments evaluated levels of GH, adrenocorticotropic hormone, thyroid-stimulating hormone, cortisol, and prolactin. Safety was assessed based on treatment-emergent adverse events (TEAEs), vital signs, 12‑lead electrocardiograms, and laboratory parameters.
RESULTS


A total of 28 healthy adults were enrolled and completed the study. Macimorelin AUC and C max  showed less than dose-proportional increases following administration of 0.5 and 1.0 mg/kg. Mean t 1/2  was 3.51 h for macimorelin 0.5 and 1.0 mg/kg and 8.29 h for macimorelin 2.0 mg/kg; median t max  occurred at 0.5 to 0.75 h. GH levels increased after dosing, with a t max  of 0.75 h to 1.0 h. Mean GH C max  was similar with the macimorelin 0.5- and 1.0-mg/kg doses (31.9 and 37.8 ng/mL, respectively) and was ~50% lower with macimorelin 2.0 mg/kg (18.4 ng/mL). Transient increases were observed in adrenocorticotropic hormone, cortisol, and prolactin, which were not dose related. A total of 19 TEAEs were reported in 35.7% (10/28) of participants; all TEAEs were mild or moderate and resolved. A total of 12 drug-related TEAEs were reported in 8 participants. Headache was the most common drug-related TEAE. All doses of macimorelin prolonged mean QTcF by 10 to 11 ms. There were no clinically meaningful changes in vital signs or laboratory parameters.
CONCLUSIONS


Single-dose administration of macimorelin 0.5 to 2.0 mg/kg was well tolerated. Macimorelin exposure was less than dose-proportional over the dose range studied. Administration of macimorelin stimulated GH production, with the greatest increases observed in the macimorelin 0.5- and 1.0-mg/kg groups.",2020,"Safety was assessed based on treatment-emergent adverse events (TEAEs), vital signs, 12‑lead electrocardiograms, and laboratory parameters.
","['28 healthy adults', 'healthy adults']","['macimorelin', 'macimorelin prolonged mean', 'placebo']","['Pharmacodynamic assessments evaluated levels of GH, adrenocorticotropic hormone, thyroid-stimulating hormone, cortisol, and prolactin', 'safety, tolerability, pharmacokinetics, and pharmacodynamics', 'GH levels', 'Headache', 'vital signs or laboratory parameters', 'tolerated', 'Pharmacokinetic parameters assessed included area under the concentration-time curve (AUC), maximum concentration (C max ) of macimorelin in plasma, time to C max  (t max ), and terminal elimination half-life', 'Mean GH C max', 'treatment-emergent adverse events (TEAEs), vital signs, 12‑lead electrocardiograms, and laboratory parameters', 'adrenocorticotropic hormone, cortisol, and prolactin', 'Safety, tolerability, pharmacokinetics, and pharmacodynamics of macimorelin', 'Macimorelin AUC and C max']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C2986922', 'cui_str': 'macimorelin'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0202056', 'cui_str': 'Growth hormone measurement'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C2986922', 'cui_str': 'macimorelin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]",28.0,0.152206,"Safety was assessed based on treatment-emergent adverse events (TEAEs), vital signs, 12‑lead electrocardiograms, and laboratory parameters.
","[{'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Klaus', 'Affiliation': 'Nuvisan GmbH, Neu-Ulm, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Sachse', 'Affiliation': 'Aeterna Zentaris GmbH, Frankfurt, Germany.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Ammer', 'Affiliation': 'Aeterna Zentaris GmbH, Frankfurt, Germany.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Kelepouris', 'Affiliation': 'Novo Nordisk Inc., Plainsboro, New Jersey, United States. Electronic address: nlkp@novonordisk.com.'}, {'ForeName': 'Vlady', 'Initials': 'V', 'LastName': 'Ostrow', 'Affiliation': 'Novo Nordisk Inc., Plainsboro, New Jersey, United States.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.101321']
234,32194222,Improvement of NRF2 gene expression and antioxidant status in patients with type 2 diabetes mellitus after supplementation with omega-3 polyunsaturated fatty acids: A double-blind randomised placebo-controlled clinical trial.,"BACKGROUND


Nrf2 is a transcription factor that induces the expression of several proteins with antioxidant properties such as sestrin2 (Sesn2) and is therefore considered as the major regulator of anti-oxidative defence system.
OBJECTIVES


The aim of this research was to study the effect of supplementation with n-3 PUFAs on the antioxidant status and the gene expression of Nrf2 and Sestrin2 (Sesn2) in patients with type 2 diabetes mellitus (T2DM).
PARTICIPANTS


Sixty patients with T2DM were enrolled in a placebo-controlled, double-blind, randomised clinical trial.
INTERVENTION AND DESIGN


The participants were randomly allocated to two intervention groups receiving either n-3 PUFAs (2,700 mg/day) (n = 30) or placebo soft gels containing 900 mg of edible paraffin (n = 30). The main outcome measures were the expression of Sesn2 and Nrf2 genes which were assessed in peripheral blood mononuclear cells (PBMCs) after RNA extraction and cDNA synthesis by real-time PCR. Total antioxidant status in plasma samples was also measured based on the ferric reducing ability of plasma.
RESULTS


NRF2 gene expression was significantly increased in n-3 PUFA-supplemented subjects, compared with the placebo group. Plasma total antioxidant status was also significantly augmented in n-3 PUFA-supplemented subjects. SESN2 gene expression was not significantly affected by n-3 PUFA supplementation although a slight up-regulation was observed.
CONCLUSION


Supplementation with n-3 PUFAs enhanced NRF2 gene expression and improved overall antioxidant capacity and thus might be considered beneficial in the amelioration of oxidative stress and prevention of T2DM complications.
TRIAL REGISTRATION


IRCT20150926024198N4.",2020,"RESULTS


Nrf2 gene expression was significantly increased in n-3 PUFA-supplemented subjects, compared with the placebo group.","['patients with type 2 diabetes mellitus after supplementation with', 'Sixty patients with T2DM were enrolled in a', 'patients with type 2 diabetes mellitus (T2DM']","['placebo soft gels containing 900 mg of edible paraffin', 'n-3 PUFAs', 'omega-3 polyunsaturated fatty acids', 'placebo', 'n-3 PUFA supplementation']","['expression of Sesn2 and Nrf2 genes which were assessed in peripheral blood mononuclear cells (PBMCs) after RNA extraction and cDNA synthesis by real-time PCR', 'Plasma total antioxidant status', 'Sesn2 gene expression', 'Total antioxidant status in plasma samples', 'antioxidant status and the gene expression of Nrf2 and Sestrin2 (Sesn2', 'overall antioxidant capacity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205358', 'cui_str': 'Soft (qualifier value)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C0030415', 'cui_str': 'Paraffin'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C3839010', 'cui_str': 'RNA extraction'}, {'cui': 'C0006556', 'cui_str': 'cDNA'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",60.0,0.432506,"RESULTS


Nrf2 gene expression was significantly increased in n-3 PUFA-supplemented subjects, compared with the placebo group.","[{'ForeName': 'Pegah', 'Initials': 'P', 'LastName': 'Golpour', 'Affiliation': 'Department of Biology, Science and Research Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Nourbakhsh', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran; Finetech in Medicine Research Center, Iran University of Medical Sciences, Tehran, Iran. Electronic address: nourbakhsh.m@iums.ac.ir.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mazaherioun', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, International Campus, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Janani', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Nourbakhsh', 'Affiliation': 'Hazrat Aliasghar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parichehreh', 'Initials': 'P', 'LastName': 'Yaghmaei', 'Affiliation': 'Department of Biology, Science and Research Branch, Islamic Azad University, Tehran, Iran.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108120']
235,32217148,"Oleoylethanolamide supplementation in obese patients newly diagnosed with non-alcoholic fatty liver disease: Effects on metabolic parameters, anthropometric indices, and expression of PPAR-α, UCP1, and UCP2 genes.","The effects of oleoylethanolamide (OEA) on NAFLD are yet to be examined in human. The objective of the present study was to examine the effects of OEA supplementation along with weight loss intervention on the expression of PPAR-α, uncoupling proteins 1and 2 (UCP1 and UCP2) genes in the peripheral blood mononuclear cells (PBMCs), metabolic parameters, and anthropometric indices among obese patients with NAFLD. In this triple-blind placebo-controlled randomized clinical trial, 76 obese patients newly diagnosed with NAFLD were randomly allocated into either OEA or placebo group along with calorie-restricted diets for 12 weeks. At pre-and post-intervention phase, mRNA expression levels of PPAR-α, UCP1, and UCP2 genes in the PBMCs, serum levels of metabolic parameters as well as diet and appetite sensations were assessed. There was a significant increase in the expression levels of PPAR-α, UCP1, and UCP2 genes in the PBMCs, compared to the placebo at the endpoint. A significant decrease in the anthropometric indices, energy and carbohydrate intakes, glycemic parameters, except for hemoglobin A1c concentration was also observed in the OEA group, compared to the placebo group. OEA treatment significantly resulted in decreased serum levels of triglyceride (TG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), ALT/AST, increased serum levels of high-density lipoprotein cholesterol (HDL-C), and improved appetite sensations. Importantly, a significant improvement in TG, ALT, AST, ALT/AST, HDL-C levels as well as appetite sensations by OEA were under the influence of body mass index (BMI). Although liver steatosis severity was significantly reduced in both groups, the between-group differences did not reach statistical significance (P = 0.061). In conclusion, the present study, for the first time, revealed that OEA supplementation significantly improved anthropometric and metabolic risk factors related to NAFLD.",2020,"There was a significant increase in the expression levels of PPAR-α, UCP1, and UCP2 genes in the PBMCs, compared to the placebo at the endpoint.","['76 obese patients newly diagnosed with NAFLD', 'obese patients newly diagnosed with non-alcoholic fatty liver disease', 'obese patients with NAFLD']","['OEA', 'oleoylethanolamide (OEA', 'Oleoylethanolamide supplementation', 'placebo', 'OEA supplementation', 'OEA or placebo']","['liver steatosis severity', 'mRNA expression levels of PPAR-α, UCP1, and UCP2 genes in the PBMCs, serum levels of metabolic parameters as well as diet and appetite sensations', 'serum levels of triglyceride (TG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), ALT/AST, increased serum levels of high-density lipoprotein cholesterol (HDL-C), and improved appetite sensations', 'expression levels of PPAR-α, UCP1, and UCP2 genes', 'TG, ALT, AST, ALT/AST, HDL-C levels', 'anthropometric indices, energy and carbohydrate intakes, glycemic parameters, except for hemoglobin A1c concentration', 'expression of PPAR-α, uncoupling proteins 1and 2 (UCP1 and UCP2) genes in the peripheral blood mononuclear cells (PBMCs), metabolic parameters, and anthropometric indices', 'anthropometric and metabolic risk factors']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}]","[{'cui': 'C1454896', 'cui_str': 'oleoylethanolamide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0166418', 'cui_str': 'Peroxisome Proliferator-Activated Receptors'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0332300', 'cui_str': 'Except for (attribute)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",76.0,0.0855709,"There was a significant increase in the expression levels of PPAR-α, UCP1, and UCP2 genes in the PBMCs, compared to the placebo at the endpoint.","[{'ForeName': 'Helda', 'Initials': 'H', 'LastName': 'Tutunchi', 'Affiliation': 'Student Research Committee, Nutrition Research Center, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: helda.nutrition@gmail.com.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ostadrahimi', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: ostadrahimi@tbzmed.ac.ir.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Saghafi-Asl', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Saghafiaslm@gmail.com.'}, {'ForeName': 'Mohammad-Javad', 'Initials': 'MJ', 'LastName': 'Hosseinzadeh-Attar', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: mhosseinzadeh@tums.ac.ir.'}, {'ForeName': 'Abolhasan', 'Initials': 'A', 'LastName': 'Shakeri', 'Affiliation': 'Department of Radiology, Imam Reza Teaching Hospital, Clinical Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: shakeria@tbzmed.ac.ir.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Asghari-Jafarabadi', 'Affiliation': 'Road Traffic Injury Research Center, School of Health, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: m.asghari862@gmail.com.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Roshanravan', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Neda.roshanravan10@gmail.com.'}, {'ForeName': 'Nazila', 'Initials': 'N', 'LastName': 'Farrin', 'Affiliation': 'Nutrition Research Center, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: nazilafarrin@gmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Naemi', 'Affiliation': 'Student Research Committee, Nutrition Research Center, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Hasankhani', 'Affiliation': 'Student Research Committee, Nutrition Research Center, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Pharmacological research,['10.1016/j.phrs.2020.104770']
236,32244028,Network topology and machine learning analyses reveal microstructural white matter changes underlying Chinese medicine Dengzhan Shengmai treatment on patients with vascular cognitive impairment.,"With the increasing incidence of cerebrovascular diseases and dementia, considerable efforts have been made to develop effective treatments on vascular cognitive impairment (VCI), among which accumulating practice-based evidence has shown great potential of the traditional Chinese medicine (TCM). Current randomized double-blind controlled trial has been designed to evaluate the 6-month treatment effects of Dengzhan Shengmai (DZSM) capsules, one TCM herbal preparations on VCI, and to explore the underlying neural mechanisms with graph theory-based analysis and machine learning method based on diffusion tensor imaging (DTI) data. A total of 82 VCI patients were recruited and randomly assigned to drug (45 with DZSM) and placebo (37 with placebo) groups, and neuropsychological and neuroimaging data were acquired at baseline and after 6-month treatment. After treatment, compared to the placebo group, the drug groups showed significantly improved performance in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog) score (p < 0.001) and the other cognitive domains. And with the reconstruction of white matter structural network, there were more streamlines connecting the left thalamus and right hippocampus in the drug groups (p < 0.001 uncorrected), with decreasing nodal efficiency of the right olfactory associated with slower decline in the general cognition (r = -0.364, p = 0.048). Moreover, support vector machine classification analyses revealed significant white matter network alterations after treatment in the drug groups (accuracy of baseline vs. 6-month later, 68.18 %). Taking together, the present study showed significant efficacy of DZSM treatment on VCI, which might result from white matter microstructure alterations and the topological changes in brain structural network.",2020,"After treatment, compared to the placebo group, the drug groups showed significantly improved performance in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog) score (p < 0.001) and the other cognitive domains.","['82 VCI patients', 'patients with vascular cognitive impairment']","['Dengzhan Shengmai (DZSM) capsules, one TCM herbal preparations', 'placebo', 'Network topology and machine learning', 'placebo (37 with placebo', 'DZSM']","['general cognition', 'white matter network alterations', 'nodal efficiency', ""performance in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog) score""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3805043', 'cui_str': 'Vascular cognitive impairment'}]","[{'cui': 'C3885966', 'cui_str': 'shengmai'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0949854', 'cui_str': 'Plant Preparation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0002812', 'cui_str': 'Regional Anatomy'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",82.0,0.257526,"After treatment, compared to the placebo group, the drug groups showed significantly improved performance in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog) score (p < 0.001) and the other cognitive domains.","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'School of Traditional Chinese Medicine, Southern Medical University, Guangzhou 510515, PR China.'}, {'ForeName': 'Junying', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, PR China; State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'School of Biomedical Engineering, Capital Medical University, Beijing, 100069, PR China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Qiao', 'Affiliation': 'China-Japan Friendship Hospital 100029, PR China.'}, {'ForeName': 'Caishui', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Xuwen', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Wenxiao', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Shaokun', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Dongfeng', 'Initials': 'D', 'LastName': 'Wei', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, PR China; State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, PR China; State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'School of Traditional Chinese Medicine, Southern Medical University, Guangzhou 510515, PR China. Electronic address: chengweidong888@sina.com.'}, {'ForeName': 'Zhanjun', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China. Electronic address: zhang_rzs@bnu.edu.cn.'}]",Pharmacological research,['10.1016/j.phrs.2020.104773']
237,30368651,"A Qualitative Exploration of Women's Experiences with a Community Health Volunteer-Led Cervical Cancer Educational Module in Migori County, Kenya.","Detection and treatment of human papillomavirus (HPV) and cervical precancer through screening programs is an effective way to reduce cervical cancer deaths. However, high cervical cancer mortality persists in low- and middle-income countries. As screening programs become more widely available, it is essential to understand how knowledge about cervical cancer and perceived disease risk impacts screening uptake and acceptability. We evaluated women's experiences with a cervical cancer education strategy led by community health volunteers (CHVs) in Migori County, Kenya, as part of a cluster randomized controlled trial of cervical cancer screening implementation strategies. The educational modules employed simple language and images and sought to increase understanding of the relationship between HPV and cervical cancer, the mechanisms of self-collected HPV testing, and the importance of cervical cancer screening. Modules took place in three different contexts throughout the study: (1) during community mobilization; (2) prior to screening in either community health campaigns or health facilities; and (3) prior to treatment. Between January and September 2016, we conducted in-depth interviews with 525 participants to assess their experience with various aspects of the screening program. After the context-specific educational modules, women reported increased awareness of cervical cancer screening and willingness to screen, described HPV- and cervical cancer-related stigma and emphasized the use of educational modules to reduce stigma. Some misconceptions about cervical cancer were evident. With effective and context-specific training, lay health workers, such as CHVs, can help bridge the gap between cervical cancer screening uptake and acceptability.",2020,"After the context-specific educational modules, women reported increased awareness of cervical cancer screening and willingness to screen, described HPV- and cervical cancer-related stigma and emphasized the use of educational modules to reduce stigma.","[""women's experiences with a cervical cancer education strategy led by community health volunteers (CHVs) in Migori County, Kenya"", ""Women's Experiences with a Community Health Volunteer-Led Cervical Cancer Educational Module in Migori County, Kenya"", '525 participants to assess their experience with various aspects of the screening program']",[],"['awareness of cervical cancer screening and willingness to screen, described HPV- and cervical cancer-related stigma', 'cervical cancer mortality']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],"[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0196419,"After the context-specific educational modules, women reported increased awareness of cervical cancer screening and willingness to screen, described HPV- and cervical cancer-related stigma and emphasized the use of educational modules to reduce stigma.","[{'ForeName': 'Yujung', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Duke Global Health Institute, Box 90519, 310 Trent Drive, Durham, NC, 27708, USA. yujung.choi@duke.edu.'}, {'ForeName': 'Sandra Y', 'Initials': 'SY', 'LastName': 'Oketch', 'Affiliation': 'Center for Microbiology Research, Kenya Medical Research Institute, P.O. Box 54840 00200, Mbagathi Road, Nairobi, Kenya.'}, {'ForeName': 'Konyin', 'Initials': 'K', 'LastName': 'Adewumi', 'Affiliation': 'Duke Global Health Institute, Box 90519, 310 Trent Drive, Durham, NC, 27708, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bukusi', 'Affiliation': 'Center for Microbiology Research, Kenya Medical Research Institute, P.O. Box 54840 00200, Mbagathi Road, Nairobi, Kenya.'}, {'ForeName': 'Megan J', 'Initials': 'MJ', 'LastName': 'Huchko', 'Affiliation': 'Duke Global Health Institute, Box 90519, 310 Trent Drive, Durham, NC, 27708, USA.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1437-2']
238,32338621,Effectiveness of a Home-Based Rehabilitation Program After Total Hip Arthroplasty Driven by a Tablet App and Remote Coaching: Nonrandomized Controlled Trial Combining a Single-Arm Intervention Cohort With Historical Controls.,"BACKGROUND


Recent technological developments such as wearable sensors and tablets with a mobile internet connection hold promise for providing electronic health home-based programs with remote coaching for patients following total hip arthroplasty. It can be hypothesized that such a home-based rehabilitation program can offer an effective alternative to usual care.
OBJECTIVE


The aim of this study was to determine the effectiveness of a home-based rehabilitation program driven by a tablet app and remote coaching for patients following total hip arthroplasty.
METHODS


Existing data of two studies were combined, in which patients of a single-arm intervention study were matched with historical controls of an observational study. Patients aged 18-65 years who had undergone total hip arthroplasty as a treatment for primary or secondary osteoarthritis were included. The intervention consisted of a 12-week home-based rehabilitation program with video instructions on a tablet and remote coaching (intervention group). Patients were asked to do strengthening and walking exercises at least 5 days a week. Data of the intervention group were compared with those of patients who received usual care (control group). Effectiveness was measured at four moments (preoperatively, and 4 weeks, 12 weeks, and 6 months postoperatively) by means of functional tests (Timed Up & Go test and the Five Times Sit-to Stand Test) and self-reported questionnaires (Hip disability and Osteoarthritis Outcome Score [HOOS] and Short Form 36 [SF-36]). Each patient of the intervention group was matched with two patients of the control group. Patient characteristics were summarized with descriptive statistics. The 1:2 matching situation was analyzed with a conditional logistic regression. Effect sizes were calculated by Cohen d.
RESULTS


Overall, 15 patients of the intervention group were included in this study, and 15 and 12 subjects from the control group were matched to the intervention group, respectively. The intervention group performed functional tests significantly faster at 12 weeks and 6 months postoperatively. The intervention group also scored significantly higher on the subscales ""function in sport and recreational activities"" and ""hip-related quality of life"" of HOOS, and on the subscale ""physical role limitations"" of SF-36 at 12 weeks and 6 months postoperatively. Large effect sizes were found on functional tests at 12 weeks and at 6 months (Cohen d=0.5-1.2), endorsed by effect sizes on the self-reported outcomes.
CONCLUSIONS


Our results clearly demonstrate larger effects in the intervention group compared to the historical controls. These results imply that a home-based rehabilitation program delivered by means of internet technology after total hip arthroplasty can be more effective than usual care.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03846063; https://clinicaltrials.gov/ct2/show/NCT03846063 and German Registry of Clinical Trials DRKS00011345; https://tinyurl.com/yd32gmdo.",2020,"The intervention group also scored significantly higher on the subscales ""function in sport and recreational activities"" and ""hip-related quality of life"" of HOOS, and on the subscale ""physical role limitations"" of SF-36 at 12 weeks and 6 months postoperatively.","['patients following total hip arthroplasty', 'Patients aged 18-65 years who had undergone total hip arthroplasty as a treatment for primary or secondary osteoarthritis were included']","['home-based rehabilitation program driven by a tablet app and remote coaching', 'Home-Based Rehabilitation Program', 'strengthening and walking exercises', '12-week home-based rehabilitation program with video instructions on a tablet and remote coaching (intervention group', 'usual care']","['Sit-to Stand Test) and self-reported questionnaires (Hip disability and Osteoarthritis Outcome Score [HOOS] and Short Form 36 [SF-36', 'subscales ""function in sport and recreational activities"" and ""hip-related quality of life"" of HOOS, and on the subscale ""physical role limitations"" of SF-36', 'Effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C2732281', 'cui_str': 'Secondary osteoarthritis'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2960303', 'cui_str': 'Hip disability and osteoarthritis outcome score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.049398,"The intervention group also scored significantly higher on the subscales ""function in sport and recreational activities"" and ""hip-related quality of life"" of HOOS, and on the subscale ""physical role limitations"" of SF-36 at 12 weeks and 6 months postoperatively.","[{'ForeName': 'Annet', 'Initials': 'A', 'LastName': 'Wijnen', 'Affiliation': 'Department of Orthopedics, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Jildou', 'Initials': 'J', 'LastName': 'Hoogland', 'Affiliation': 'Department of Orthopedics, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Tjerk', 'Initials': 'T', 'LastName': 'Munsterman', 'Affiliation': 'Department of Physiotherapy, Martini Hospital Groningen, Groningen, Netherlands.'}, {'ForeName': 'Carina LE', 'Initials': 'CL', 'LastName': 'Gerritsma', 'Affiliation': 'Department of Orthopedics, Martini Hospital Groningen, Groningen, Netherlands.'}, {'ForeName': 'Baukje', 'Initials': 'B', 'LastName': 'Dijkstra', 'Affiliation': 'Department of Orthopedics, Medical Center Leeuwarden, Leeuwarden, Netherlands.'}, {'ForeName': 'Wierd P', 'Initials': 'WP', 'LastName': 'Zijlstra', 'Affiliation': 'Department of Orthopedics, Medical Center Leeuwarden, Leeuwarden, Netherlands.'}, {'ForeName': 'Johan S', 'Initials': 'JS', 'LastName': 'Dekker', 'Affiliation': 'Department of Orthopedics, Ommelander Ziekenhuis Groep, Scheemda, Netherlands.'}, {'ForeName': 'Janneke', 'Initials': 'J', 'LastName': 'Annegarn', 'Affiliation': 'Collaborative Care Solutions, Philips Research, Eindhoven, Netherlands.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Ibarra', 'Affiliation': 'University of Trento, Trento, Italy.'}, {'ForeName': 'Geranda Ec', 'Initials': 'GE', 'LastName': 'Slager', 'Affiliation': 'Department of Physical Therapy, School of Health Care Studies, Hanze University of Applied Sciences, Groningen, Netherlands.'}, {'ForeName': 'Wiebren', 'Initials': 'W', 'LastName': 'Zijlstra', 'Affiliation': 'Institute of Movement and Sport Gerontology, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Stevens', 'Affiliation': 'Department of Orthopedics, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.'}]",JMIR rehabilitation and assistive technologies,['10.2196/14139']
239,32338622,Implementation and Effects of Information Technology-Based and Print-Based Interventions to Promote Physical Activity Among Community-Dwelling Older Adults: Protocol for a Randomized Crossover Trial.,"BACKGROUND


Despite the known health benefits of physical activity (PA), less than half and less than one-third of older adults in Germany reach the PA recommendations for endurance training and strength training, respectively, of the World Health Organization. The aim of this study is to investigate the implementation and effectiveness over the course of 9 months of two interventions (information technology [IT]-based vs print-based) for PA promotion among initially inactive older adults in a randomized, crossover trial. This study is part of a large research consortium (2015-2021) investigating different aspects of PA promotion. The IT-based intervention was previously developed and refined, while the print-based intervention was newly developed during this funding phase.
OBJECTIVE


We aim to compare the effectiveness and examine the preferences of study participants regarding both delivery modes.
METHODS


Our target sample size was 390 initially inactive community-dwelling older adults aged ≥60 years at baseline (3-month follow-up [T1]: expected n=300; 9-month follow-up [T2]: expected n=240) who were randomized to one of two interventions for self-monitoring PA: IT-based (50%) or print-based (50%) intervention. In addition, 30% of the IT-based intervention group received a PA tracker. At T1, participants in both groups could choose whether they prefered to keep their assigned intervention or cross over to the other group for the following 6 months (T2). Participants' intervention preferences at baseline were collected retrospectively to run a post hoc matched-mismatched analysis. During the initial 3-month intervention period, both intervention groups were offered weekly group sessions that were continued monthly between T1 and T2. A self-administered questionnaire and 3D accelerometers were employed to assess changes in PA between baseline, T1, and T2. Adherence to PA recommendations, attendance at group sessions, and acceptance of the interventions were also tracked.
RESULTS


The funding period started in February 2018 and ends in January 2021. We obtained institutional review board approval for the study from the Medical Association in Bremen on July 3, 2018. Data collection was completed on January 31, 2020, and data cleaning and analysis started in February 2020. We expect to publish the first results by the end of the funding period.
CONCLUSIONS


Strategies to promote active aging are of particular relevance in Germany, as 29% of the population is projected to be ≥65 years old by 2030. Regular PA is a key contributor to healthy aging. This study will provide insights into the acceptance and effectiveness of IT-based vs print-based interventions to promote PA in initially inactive individuals aged ≥60 years. Results obtained in this study will improve the existing evidence base on the effectiveness of community-based PA interventions in Germany and will inform efforts to anchor evidence-based PA interventions in community structures and organizations via an allocation of permanent health insurance funds.
TRIAL REGISTRATION


German Registry of Clinical Trials DRKS00016073; https://tinyurl.com/y983586m.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/15168.",2020,"During the initial 3-month intervention period, both intervention groups were offered weekly group sessions that were continued monthly between T1 and T2.","['initially inactive older adults', '390 initially inactive community-dwelling older adults aged ≥60 years at baseline (3-month follow-up [T1]: expected n=300; 9-month follow-up [T2]: expected n=240', 'initially inactive individuals aged ≥60 years', 'Community-Dwelling Older Adults']","['two interventions (information technology [IT]-based vs print-based', 'self-monitoring PA', 'PA tracker', 'Information Technology-Based and Print-Based Interventions']",[],"[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021423', 'cui_str': 'Information Sciences'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",[],,0.0600252,"During the initial 3-month intervention period, both intervention groups were offered weekly group sessions that were continued monthly between T1 and T2.","[{'ForeName': 'Claudia R', 'Initials': 'CR', 'LastName': 'Pischke', 'Affiliation': 'Institute of Medical Sociology, Centre for Health and Society, Medical Faculty, University of Duesseldorf, Duesseldorf, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Voelcker-Rehage', 'Affiliation': 'Institute of Human Movement Science and Health, Chemnitz University of Technology, Chemnitz, Germany.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Peters', 'Affiliation': 'Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany.'}, {'ForeName': 'Tiara', 'Initials': 'T', 'LastName': 'Ratz', 'Affiliation': 'Jacobs University Bremen, Bremen, Germany.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Pohlabeln', 'Affiliation': 'Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Meyer', 'Affiliation': 'OFFIS - Institute for Information Technology, Oldenburg, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'von Holdt', 'Affiliation': 'OFFIS - Institute for Information Technology, Oldenburg, Germany.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Lippke', 'Affiliation': 'Jacobs University Bremen, Bremen, Germany.'}]",JMIR research protocols,['10.2196/15168']
240,32338624,A Mobile Health Solution Complementing Psychopharmacology-Supported Smoking Cessation: Randomized Controlled Trial.,"BACKGROUND


Smoking cessation is a persistent leading public health challenge. Mobile health (mHealth) solutions are emerging to improve smoking cessation treatments. Previous approaches have proposed supporting cessation with tailored motivational messages. Some managed to provide short-term improvements in smoking cessation. Yet, these approaches were either static in terms of personalization or human-based nonscalable solutions. Additionally, long-term effects were neither presented nor assessed in combination with existing psychopharmacological therapies.
OBJECTIVE


This study aimed to analyze the long-term efficacy of a mobile app supporting psychopharmacological therapy for smoking cessation and complementarily assess the involved innovative technology.
METHODS


A 12-month, randomized, open-label, parallel-group trial comparing smoking cessation rates was performed at Virgen del Rocío University Hospital in Seville (Spain). Smokers were randomly allocated to a control group (CG) receiving usual care (psychopharmacological treatment, n=120) or an intervention group (IG) receiving psychopharmacological treatment and using a mobile app providing artificial intelligence-generated and tailored smoking cessation support messages (n=120). The secondary objectives were to analyze health-related quality of life and monitor healthy lifestyle and physical exercise habits. Safety was assessed according to the presence of adverse events related to the pharmacological therapy. Per-protocol and intention-to-treat analyses were performed. Incomplete data and multinomial regression analyses were performed to assess the variables influencing participant cessation probability. The technical solution was assessed according to the precision of the tailored motivational smoking cessation messages and user engagement. Cessation and no cessation subgroups were compared using t tests. A voluntary satisfaction questionnaire was administered at the end of the intervention to all participants who completed the trial.
RESULTS


In the IG, abstinence was 2.75 times higher (adjusted OR 3.45, P=.01) in the per-protocol analysis and 2.15 times higher (adjusted OR 3.13, P=.002) in the intention-to-treat analysis. Lost data analysis and multinomial logistic models showed different patterns in participants who dropped out. Regarding safety, 14 of 120 (11.7%) IG participants and 13 of 120 (10.8%) CG participants had 19 and 23 adverse events, respectively (P=.84). None of the clinical secondary objective measures showed relevant differences between the groups. The system was able to learn and tailor messages for improved effectiveness in supporting smoking cessation but was unable to reduce the time between a message being sent and opened. In either case, there was no relevant difference between the cessation and no cessation subgroups. However, a significant difference was found in system engagement at 6 months (P=.04) but not in all subsequent months. High system appreciation was reported at the end of the study.
CONCLUSIONS


The proposed mHealth solution complementing psychopharmacological therapy showed greater efficacy for achieving 1-year tobacco abstinence as compared with psychopharmacological therapy alone. It provides a basis for artificial intelligence-based future approaches.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03553173; https://clinicaltrials.gov/ct2/show/NCT03553173.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/12464.",2020,"In the IG, abstinence was 2.75 times higher (adjusted OR 3.45, P=.01) in the per-protocol analysis and 2.15 times higher (adjusted OR 3.13, P=.002) in the intention-to-treat analysis.","['A Mobile Health Solution Complementing Psychopharmacology-Supported Smoking Cessation', 'Virgen del Rocío University Hospital in Seville (Spain']","['control group (CG) receiving usual care (psychopharmacological treatment, n=120) or an intervention group (IG) receiving psychopharmacological treatment and using a mobile app providing artificial intelligence-generated and tailored smoking cessation support messages', 'mobile app supporting psychopharmacological therapy']","['health-related quality of life and monitor healthy lifestyle and physical exercise habits', 'system engagement']","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0009498', 'cui_str': 'Complement'}, {'cui': 'C0033929', 'cui_str': 'Psychopharmacology'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",,0.0824159,"In the IG, abstinence was 2.75 times higher (adjusted OR 3.45, P=.01) in the per-protocol analysis and 2.15 times higher (adjusted OR 3.13, P=.002) in the intention-to-treat analysis.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Carrasco-Hernandez', 'Affiliation': 'Smoking Cessation Unit, Medical-Surgical Unit of Respiratory Diseases, Virgen del Rocío University Hospital, Seville, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Jódar-Sánchez', 'Affiliation': 'Research and Innovation Group in Biomedical Informatics, Biomedical Engineering and Health Economy, Institute of Biomedicine of Seville, Virgen del Rocío University Hospital, Spanish National Research Council, University of Seville, Seville, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Núñez-Benjumea', 'Affiliation': 'Research and Innovation Group in Biomedical Informatics, Biomedical Engineering and Health Economy, Institute of Biomedicine of Seville, Virgen del Rocío University Hospital, Spanish National Research Council, University of Seville, Seville, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Moreno Conde', 'Affiliation': 'Research and Innovation Group in Biomedical Informatics, Biomedical Engineering and Health Economy, Institute of Biomedicine of Seville, Virgen del Rocío University Hospital, Spanish National Research Council, University of Seville, Seville, Spain.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Mesa González', 'Affiliation': 'Smoking Cessation Unit, Medical-Surgical Unit of Respiratory Diseases, Virgen del Rocío University Hospital, Seville, Spain.'}, {'ForeName': 'Antón', 'Initials': 'A', 'LastName': 'Civit-Balcells', 'Affiliation': 'Department of Architecture and Computer Technology, School of Computer Engineering, Universidad de Sevilla, Seville, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Hors-Fraile', 'Affiliation': 'Salumedia Labs, Seville, Spain.'}, {'ForeName': 'Carlos Luis', 'Initials': 'CL', 'LastName': 'Parra-Calderón', 'Affiliation': 'Research and Innovation Group in Biomedical Informatics, Biomedical Engineering and Health Economy, Institute of Biomedicine of Seville, Virgen del Rocío University Hospital, Spanish National Research Council, University of Seville, Seville, Spain.'}, {'ForeName': 'Panagiotis D', 'Initials': 'PD', 'LastName': 'Bamidis', 'Affiliation': 'Medical Physics Laboratory, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Ortega-Ruiz', 'Affiliation': 'Smoking Cessation Unit, Medical-Surgical Unit of Respiratory Diseases, Virgen del Rocío University Hospital, Seville, Spain.'}]",JMIR mHealth and uHealth,['10.2196/17530']
241,32336236,Blood Pressure-Lowering Profiles and Clinical Effects of Angiotensin Receptor Blockers Versus Calcium Channel Blockers.,"Blood pressure-lowering drugs have different blood pressure-lowering profiles. We studied if differences in blood pressure mean and variability can explain the differences in risks of cardiovascular events and death among 15 245 high-risk hypertensive patients randomized to valsartan or amlodipine and followed for 4.2 years in the VALUE trial (Valsartan Antihypertensive Long-Term Use Evaluation). We selected patients with ≥3 visits and performed Cox regression analyses, defining mean blood pressure as a time-dependent covariate and visit-to-visit and within-visit blood pressure variability as the SD. Of 14 996 eligible patients, participants in the valsartan group had higher systolic mean blood pressure by 2.2 mm Hg, higher visit-to-visit systolic variability by 1.4 mm Hg, and higher within-visit systolic variability by 0.2 mm Hg ( P  values <0.0001). The higher risks of myocardial infarction and stroke in the valsartan group was attenuated after adjustment for mean and variability of systolic blood pressure, from HR 1.19 (95% CI, 1.02-1.39) to 1.11 (0.96-1.30) and from HR 1.13 (0.96-1.33) to 1.00 (0.85-1.18), respectively. The lower risk of congestive heart failure in the valsartan group was accentuated after adjustment, from HR 0.86 (0.74-1.00) to 0.76 (0.65-0.89). A smaller effect was seen on risk of death, from 1.01 (0.92-1.12) to 0.94 (0.85-1.04). In conclusion, the higher risks of myocardial infarction and stroke in patients randomized to valsartan versus amlodipine were related to the drugs' different blood pressure modulating profiles. The risk of congestive heart failure with valsartan was lower, independent of the less favorable blood pressure modulating profile.",2020,"A smaller effect was seen on risk of death, from 1.01 (0.92-1.12) to 0.94 (0.85-1.04).","['Of 14 996 eligible patients, participants in the', '15 245 high-risk hypertensive patients randomized to']","['Angiotensin Receptor Blockers Versus Calcium Channel Blockers', 'valsartan', 'valsartan or amlodipine', 'amlodipine']","['higher risks of myocardial infarction and stroke', 'systolic blood pressure', 'visit systolic variability', 'myocardial infarction and stroke', 'risk of congestive heart failure', 'visit-to-visit systolic variability', 'lower risk of congestive heart failure', 'blood pressure mean', 'systolic mean blood pressure', 'risk of death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}]","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",14996.0,0.0478052,"A smaller effect was seen on risk of death, from 1.01 (0.92-1.12) to 0.94 (0.85-1.04).","[{'ForeName': 'Maria H', 'Initials': 'MH', 'LastName': 'Mehlum', 'Affiliation': 'From the Department of Geriatric Medicine (M.H.M., T.B.W.), Oslo University Hospital Ullevaal, Oslo, Norway.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Liestøl', 'Affiliation': 'Department of Informatics (K.L.), University of Oslo, Norway.'}, {'ForeName': 'Sverre E', 'Initials': 'SE', 'LastName': 'Kjeldsen', 'Affiliation': 'Department of Cardiology (S.E.K., E.B.), Oslo University Hospital Ullevaal, Oslo, Norway.'}, {'ForeName': 'Torgeir B', 'Initials': 'TB', 'LastName': 'Wyller', 'Affiliation': 'From the Department of Geriatric Medicine (M.H.M., T.B.W.), Oslo University Hospital Ullevaal, Oslo, Norway.'}, {'ForeName': 'Stevo', 'Initials': 'S', 'LastName': 'Julius', 'Affiliation': 'Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (S.E.K., S.J.).'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Rothwell', 'Affiliation': 'Stroke Prevention Research Unit, Nuffield Department of Clinical Neuroscience, John Radcliffe Hospital, University of Oxford, United Kingdom (P.M.R.).'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Mancia', 'Affiliation': 'Policlinico di Monza, Monza, Italy (G.M.).'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Parati', 'Affiliation': 'University of Milano-Bicocca, Milan, Italy (G.M., G.P.).'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Weber', 'Affiliation': 'Department of Cardiovascular Medicine, State University of New York, Downstate College of Medicine (M.A.W.).'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Berge', 'Affiliation': 'Department of Cardiology (S.E.K., E.B.), Oslo University Hospital Ullevaal, Oslo, Norway.'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.119.14443']
242,32305012,"The effect of combined functional training on BDNF, IGF-1, and their association with health-related fitness in the multiple sclerosis women.","OBJECTIVE


Exercise-induced changes in the neurotrophic factors and the physical function are essential for the rehabilitation of the multiple sclerosis (MS) persons. The aim of this study was investigating of effectiveness of the combined functional training (CFT) on brain-derived neurotrophic factor (BDNF), insulin-like growth factor-1 (IGF-1), and their association with health-related fitness in the MS women.
DESIGN


Twenty women with relapsing-remitting MS randomly assigned to CFT and control (CON) groups. The CFT consisted of 8 weeks (3 days per week) rhythmic aerobic exercise, TRX suspension training, elastic band training, and bodyweight training. BDNF, IGF-1, and health-related fitness components were assessed before and after the intervention.
RESULTS


There was no significant difference in BDNF level between the CFT and the CON group. In contrast, IGF-1, walking speed, and strength of the right- and left-hand was significantly increased in the CFT compared with the CON group. Furthermore, there was a significant and positive correlation between IGF-1 and some fitness components.
CONCLUSIONS


The findings indicated that CFT might a useful training mode in the rehabilitation of the MS women. CFT improved IGF-1 level that is a neuroprotective agent in MS. Positive and significant association between IGF-1 and some health-related fitness components indicates of the importance of IGF-1 in the rehabilitation of the MS persons than BDNF.",2020,"In contrast, IGF-1, walking speed, and strength of the right- and left-hand was significantly increased in the CFT compared with the CON group.","['Twenty women with relapsing-remitting MS randomly assigned to', 'multiple sclerosis women']","['combined functional training', 'CFT', 'CFT and control (CON', 'combined functional training (CFT', 'CON', 'rhythmic aerobic exercise, TRX suspension training, elastic band training, and bodyweight training']","['brain-derived neurotrophic factor (BDNF), insulin-like growth factor-1 (IGF-1', 'BDNF, IGF-1, and health-related fitness components', 'IGF-1, walking speed, and strength of the right- and left-hand', 'IGF-1 level', 'BDNF level']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C1504637', 'cui_str': 'TXN protein, human'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",20.0,0.0229704,"In contrast, IGF-1, walking speed, and strength of the right- and left-hand was significantly increased in the CFT compared with the CON group.","[{'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Abbaspoor', 'Affiliation': 'Department of Sport Physiology and Corrective Exercise, Sport Sciences Faculty, Urmia University, Urmia, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Zolfaghari', 'Affiliation': 'Department of Sport Physiology and Corrective Exercise, Sport Sciences Faculty, Urmia University, Urmia, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Ahmadi', 'Affiliation': 'Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Kazem', 'Initials': 'K', 'LastName': 'Khodaei', 'Affiliation': 'Department of Sport Physiology and Corrective Exercise, Sport Sciences Faculty, Urmia University, Urmia, Iran. Electronic address: k.khodaei@urmia.ac.ir.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.101320']
243,32305456,Computerized intervention for reducing intimate partner victimization for perinatal women seeking mental health treatment: A multisite randomized clinical trial protocol.,"Intimate partner victimization (IPV) is a significant social and public health problem among perinatal women. Research suggests that 21% to 33% of perinatal women report IPV and there is an enormous amount of morbidity associated with IPV. Moreover, IPV places women at high risk for several psychiatric disorders, which transforms the perinatal period from an already challenging process into a potentially overwhelming one. Further, IPV and untreated mental illness during the perinatal period pose a dual risk of adverse physical and emotional outcomes for women and their developing fetus/infant. Given the high rates of IPV among women who seek mental health treatment, mental health clinics compared to other medical settings are more effective sites for focused case finding and intervention. Our team has successfully tested an innovative, computerized intervention, Strength for U in Relationship Empowerment (SURE). SURE is a brief, interactive program consistent with motivational interviewing and incorporates empowerment strategies. The proposed multisite randomized clinical trial (N = 186) will test whether SURE relative to control is associated with reduced IPV, greater positive affect and well-being, and greater perceived emotional support. We will also evaluate the role of theoretical mediators of empowerment and self-efficacy. Finally, we will estimate the resources needed and costs to deliver SURE, as well as the incremental cost effectiveness of SURE compared with treatment as usual. If SURE is found to be efficacious and cost effective, it can be easily integrated into clinical care and will fill a critical gap for a vulnerable, high-risk population.",2020,"Our team has successfully tested an innovative, computerized intervention, Strength for U in Relationship Empowerment","['perinatal women seeking mental health treatment', 'women who seek mental health treatment, mental health clinics', 'perinatal women', 'women and their developing fetus/infant']","['Intimate partner victimization (IPV', 'Computerized intervention']",['adverse physical and emotional outcomes'],"[{'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0699756', 'cui_str': 'Intimate'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",186.0,0.0511695,"Our team has successfully tested an innovative, computerized intervention, Strength for U in Relationship Empowerment","[{'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychology, University of Akron, Akron, OH 44325-4301, USA. Electronic address: johnsod@uakron.edu.'}, {'ForeName': 'Golfo', 'Initials': 'G', 'LastName': 'Tzilos Wernette', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Ted R', 'Initials': 'TR', 'LastName': 'Miller', 'Affiliation': 'Pacific Institute for Research and Evaluation, Calverton, MD, USA; School of Public Health, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Muzik', 'Affiliation': 'Department of Psychiatry, Obstetrics & Gynecology, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Raker', 'Affiliation': ""Division of Research, Women and Infant's Hospital, Providence, RI, USA.""}, {'ForeName': 'Caron', 'Initials': 'C', 'LastName': 'Zlotnick', 'Affiliation': ""Department of Medicine, Women and Infant's Hospital, Providence, RI, USA; Department of Psychiatry and Human Behavior, Brown University, Providence, RI, USA.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106011']
244,32305457,"Translating research into practice: Protocol for a community-engaged, stepped wedge randomized trial to reduce disparities in breast cancer treatment through a regional patient navigation collaborative.","BACKGROUND


Racial and socioeconomic disparities in breast cancer mortality persist. In Boston, MA, Black, Non-Hispanic women and Medicaid-insured individuals are 2-3 times more likely to have delays in treatment compared to White or privately insured women. While evidence-based care coordination strategies for reducing delays exist, they are not systematically implemented across healthcare settings.
METHODS


Translating Research Into Practice (TRIP) utilizes community engaged research methods to address breast cancer care delivery disparities. Four Massachusetts Clinical and Translational Science Institute (CTSI) hubs collaborated with the Boston Breast Cancer Equity Coalition (The Coalition) to implement an evidence-based care coordination intervention for Boston residents at risk for delays in breast cancer care. The Coalition used a community-driven process to define the problem of care delivery disparities, identify the target population, and develop a rigorous pragmatic approach. We chose a cluster-randomized, stepped-wedge hybrid type I effectiveness-implementation study design. The intervention implements three evidence-based strategies: patient navigation services, a shared patient registry for use across academic medical centers, and a web-based social determinants of health platform to identify and address barriers to care. Primary clinical outcomes include time to first treatment and receipt of guideline-concordant treatment, which are captured through electronic health records abstraction. We will use mixed methods to collect the secondary implementation outcomes of acceptability, adoption/penetration, fidelity, sustainability and cost.
CONCLUSION


TRIP utilizes an innovative community-driven research strategy, focused on interdisciplinary collaborations, to design and implement a translational science study that aims to more efficiently integrate proven health services interventions into clinical practice.",2020,"The intervention implements three evidence-based strategies: patient navigation services, a shared patient registry for use across academic medical centers, and a web-based social determinants of health platform to identify and address barriers to care.",[],['stepped-wedge hybrid type'],"['time to first treatment and receipt of guideline-concordant treatment, which are captured through electronic health records abstraction', 'acceptability, adoption/penetration, fidelity, sustainability and cost']",[],"[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.050151,"The intervention implements three evidence-based strategies: patient navigation services, a shared patient registry for use across academic medical centers, and a web-based social determinants of health platform to identify and address barriers to care.","[{'ForeName': 'Tracy A', 'Initials': 'TA', 'LastName': 'Battaglia', 'Affiliation': ""Women's Health Unit, Section of General Internal Medicine, Boston University School of Medicine, Boston, MA, United States of America. Electronic address: Tracy.Battaglia@bmc.org.""}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Freund', 'Affiliation': 'Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, United States of America; Division of Internal Medicine and Primary Care, Department of Medicine, Tufts Medical Center, Boston, MA, United States of America; Tufts University School of Medicine, Boston, MA, United States of America.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Haas', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Casanova', 'Affiliation': ""Women's Health Unit, Section of General Internal Medicine, Boston University School of Medicine, Boston, MA, United States of America.""}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Bak', 'Affiliation': ""Women's Health Unit, Section of General Internal Medicine, Boston University School of Medicine, Boston, MA, United States of America; Boston University School of Medicine, Boston, MA, United States of America.""}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Cabral', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, MA, United States of America.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Freedman', 'Affiliation': 'Department of Medical Oncology, Dana Farber Cancer Institute, Boston, MA, United States of America.'}, {'ForeName': 'Karen Burns', 'Initials': 'KB', 'LastName': 'White', 'Affiliation': 'Initiative to Eliminate Cancer Disparities, Dana Farber/Harvard Cancer Center, Boston, MA, United States of America.'}, {'ForeName': 'Stephenie C', 'Initials': 'SC', 'LastName': 'Lemon', 'Affiliation': 'Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106007']
245,32320843,"Brief cessation advice, nicotine replacement therapy sampling and active referral (BANSAR) for smoking expectant fathers: Study protocol for a multicentre, pragmatic randomised controlled trial.","BACKGROUND


Pregnancy presents a teachable moment to engage male smokers whose partners are pregnant in smoking cessation. Evidence on how to approach and help these smokers quit smoking in antenatal settings has remained scarce. This paper presents the rationale and study design of a trial which aims to evaluate the effectiveness of a brief intervention model for promoting smoking cessation in expectant fathers.
METHODS


BANSAR is a pragmatic randomised controlled trial conducted in antenatal clinic in seven public hospitals in Hong Kong, China. An estimated 1148 fathers who smoke at least one cigarette daily and whose partners are pregnant and non-smoking will be randomised (1:1) to receive brief advice combined with 1-week sample of nicotine replacement therapy (NRT) and active referral to smoking cessation services, or brief advice only (usual care). Outcome will be assessed at 3 and 6 months after treatment initiation. The primary outcome is carbon monoxide-verified (<4 part per million) abstinence at 6 months post-treatment initiation. Secondary outcomes include self-reported 7-day point-prevalence abstinence and 24-week continuous abstinence, use of smoking cessation service and NRT and quit attempt, and smoking reduction, change in nicotine dependence and intention to quit in continuing smokers.
COMMENT


This trial will provide real-world evidence on the effectiveness of a combined brief intervention model for smoking cessation in expectant fathers, an understudied population. The findings may be particularly relevant to low and middle-income countries, where male-to-female smoking ratios and birth rates tend to be higher than higher-income countries.
TRIAL REGISTRATION


ClinicalTrials.gov, number NCT03671707.",2020,"This trial will provide real-world evidence on the effectiveness of a combined brief intervention model for smoking cessation in expectant fathers, an understudied population.","['1148 fathers who smoke at least one cigarette daily and whose partners are pregnant and non-smoking', 'smoking expectant fathers', 'antenatal clinic in seven public hospitals in Hong Kong, China', 'expectant fathers']","['nicotine replacement therapy sampling and active referral (BANSAR', 'brief advice combined with 1-week sample of nicotine replacement therapy (NRT) and active referral to smoking cessation services, or brief advice only (usual care']","['carbon monoxide-verified (<4 part per million) abstinence', 'self-reported 7-day point-prevalence abstinence and 24-week continuous abstinence, use of smoking cessation service and NRT and quit attempt, and smoking reduction, change in nicotine dependence and intention to quit in continuing smokers']","[{'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0028043', 'cui_str': 'Nicotine dependence'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]",,0.144204,"This trial will provide real-world evidence on the effectiveness of a combined brief intervention model for smoking cessation in expectant fathers, an understudied population.","[{'ForeName': 'Tzu Tsun', 'Initials': 'TT', 'LastName': 'Luk', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Chi Ju', 'Initials': 'CJ', 'LastName': 'Hsieh', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Wing-Cheong', 'Initials': 'WC', 'LastName': 'Leung', 'Affiliation': 'Department of Obstetrics & Gynecology, Kwong Wah Hospital, Hong Kong.'}, {'ForeName': 'Kwok-Yin', 'Initials': 'KY', 'LastName': 'Leung', 'Affiliation': 'Department of Obstetrics & Gynecology, Queen Elizabeth Hospital, Hong Kong.'}, {'ForeName': 'Ka Wang', 'Initials': 'KW', 'LastName': 'Cheung', 'Affiliation': 'Department of Obstetrics & Gynecology, Queen Mary Hospital, Hong Kong.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Kwa', 'Affiliation': 'Department of Obstetrics & Gynecology, United Christian Hospital, Hong Kong.'}, {'ForeName': 'Kar-Hung', 'Initials': 'KH', 'LastName': 'Siong', 'Affiliation': 'Department of Obstetrics & Gynecology, Tuen Mun Hospital, Hong Kong.'}, {'ForeName': 'Kwok-Keung', 'Initials': 'KK', 'LastName': 'Tang', 'Affiliation': 'Department of Obstetrics & Gynecology, Pamela Youde Nethersole Eastern Hospital, Hong Kong.'}, {'ForeName': 'Kai-Wan', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics & Gynecology, Princess Margaret Hospital, Hong Kong.'}, {'ForeName': 'William Ho-Cheung', 'Initials': 'WH', 'LastName': 'Li', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Man Ping', 'Initials': 'MP', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong. Electronic address: mpwang@hku.hk.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106006']
246,32329737,Facilitators and Barriers to Chronic Disease Self-Management and Mobile Health Interventions for People Living With Diabetes and Hypertension in Cambodia: Qualitative Study.,"BACKGROUND


In many low- and middle-income countries (LMICs), heart disease and stroke are the leading causes of death as cardiovascular risk factors such as diabetes and hypertension rapidly increase. The Cambodian nongovernmental organization, MoPoTsyo, trains local residents with diabetes to be peer educators (PEs) to deliver chronic disease self-management training and medications to 14,000 people with hypertension and/or diabetes in Cambodia. We collaborated with MoPoTsyo to develop a mobile-based messaging intervention (mobile health; mHealth) to link MoPoTsyo's database, PEs, pharmacies, clinics, and people living with diabetes and/or hypertension to improve adherence to evidence-based treatment guidelines.
OBJECTIVE


This study aimed to understand the facilitators and barriers to chronic disease management and the acceptability, appropriateness, and feasibility of mHealth to support chronic disease management and strengthen community-clinical linkages to existing services.
METHODS


We conducted an exploratory qualitative study using semistructured interviews and focus groups with PEs and people living with diabetes and/or hypertension. Interviews were recorded and conducted in Khmer script, transcribed and translated into the English language, and uploaded into Atlas.ti for analysis. We used a thematic analysis to identify key facilitators and barriers to disease management and opportunities for mHealth content and format. The information-motivation-behavioral model was used to guide data collection, analysis, and message development.
RESULTS


We conducted six focus groups (N=59) and 11 interviews in one urban municipality and five rural operating districts from three provinces in October 2016. PE network participants desired mHealth to address barriers to chronic disease management through reminders about medications, laboratory tests and doctor's consultations, education on how to incorporate self-management into their daily lives, and support for obstacles to disease management. Participants preferred mobile-based voice messages to arrive at dinnertime for improved phone access and family support. They desired voice messages over texts to communicate trust and increase accessibility for persons with limited literacy, vision, and smartphone access. PEs shared similar views and perceived mHealth as acceptable and feasible for supporting their work. We developed 34 educational, supportive, and reminder mHealth messages based on these findings.
CONCLUSIONS


These mHealth messages are currently being tested in a cluster randomized controlled trial (#1R21TW010160) to improve diabetes and hypertension control in Cambodia. This study has implications for practice and policies in Cambodia and other LMICs and low-resource US settings that are working to engage PEs and build community-clinical linkages to facilitate chronic disease management.",2020,"PE network participants desired mHealth to address barriers to chronic disease management through reminders about medications, laboratory tests and doctor's consultations, education on how to incorporate self-management into their daily lives, and support for obstacles to disease management.","['six focus groups (N=59) and 11 interviews in one urban municipality and five rural operating districts from three provinces in October 2016', 'semistructured interviews and focus groups with PEs and people living with diabetes and/or hypertension', '14,000 people with hypertension and/or diabetes in Cambodia', 'People Living With Diabetes and Hypertension in Cambodia']",['Facilitators and Barriers to Chronic Disease Self-Management and Mobile Health Interventions'],[],"[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0006797', 'cui_str': 'Cambodia'}]","[{'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.050163,"PE network participants desired mHealth to address barriers to chronic disease management through reminders about medications, laboratory tests and doctor's consultations, education on how to incorporate self-management into their daily lives, and support for obstacles to disease management.","[{'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Steinman', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Hen', 'Initials': 'H', 'LastName': 'Heang', 'Affiliation': 'MoPoTsyo Patient Information Centre, Phnom Penh, Cambodia.'}, {'ForeName': 'Maurits', 'Initials': 'M', 'LastName': 'van Pelt', 'Affiliation': 'MoPoTsyo Patient Information Centre, Phnom Penh, Cambodia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ide', 'Affiliation': 'Division of General Internal Medicine, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Cui', 'Affiliation': 'MoPoTsyo Patient Information Centre, Phnom Penh, Cambodia.'}, {'ForeName': 'Mayuree', 'Initials': 'M', 'LastName': 'Rao', 'Affiliation': 'Division of General Internal Medicine, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'LoGerfo', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Fitzpatrick', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}]",JMIR mHealth and uHealth,['10.2196/13536']
247,32329742,The Kids Obesity Prevention Program: Cluster Randomized Controlled Trial to Evaluate a Serious Game for the Prevention and Treatment of Childhood Obesity.,"BACKGROUND


Health games provide opportunities for the treatment and prevention of childhood obesity. We developed a motion-controlled serious game for children that addresses 3 core topics of nutrition, physical activity, and stress coping. It is the first serious game that extensively targets the dietary energy density principle (DED-P) in relation to nutrition. The game is intended to provide an additional educational component for the prevention and treatment of obesity in children.
OBJECTIVE


The Kids Obesity Prevention study aimed to evaluate the newly developed game and to evaluate how well children are able to understand and apply the DED-P.
METHODS


This cluster randomized controlled trial collected data from 82 primary school children aged 9 to 12 years and their parents at baseline (T0), at 2 weeks after study commencement (T1), and at the 4-week follow-up (T2). The dropout rate was 3.6%. The intervention group (IG) played the game within 2 weeks (2 sessions with different game modules). One part of the game involves selection of food with the lower energy density when presented with a pair of foods. This allows assessment of whether the children have understood the DED-P and whether they can apply it to unknown foods under time pressure. The control group (CG) received a brochure about the food pyramid concept and physical activity. The primary outcome was the gain in knowledge (nutrition and stress coping) and measured with a pretested questionnaire. The secondary outcomes were the maintenance of knowledge, application of the DED-P, feelings during game play, game acceptance, and behavioral measures (physical activity, media consumption, and dietary intake).
RESULTS


The knowledge score ranging from 0 to 100 increased from T0 (IG: 53 [SD 10], CG: 50 [SD 11]) to T1 (IG: 69 [SD 11], CG: 52 [SD 12]) in IG versus CG (P<.001). At T2, the knowledge score of IG remained at the same level as that of T1. Game data showed that after DED-P education, the classification under time pressure of unknown versus known food pairs according to their DED category was similar (hit rate around 70%). Overall, 95% of the children liked the game very much or much. No group changes were observed at the behavioral level.
CONCLUSIONS


The Kids Obesity Prevention program sustainably increased knowledge in the areas of nutrition and stress coping, and children were able to apply the DED-P.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02551978; https://clinicaltrials.gov/ct2/show/NCT02551978.",2020,"The secondary outcomes were the maintenance of knowledge, application of the DED-P, feelings during game play, game acceptance, and behavioral measures (physical activity, media consumption, and dietary intake).
","['Childhood Obesity', '82 primary school children aged 9 to 12 years and their parents at baseline (T0), at 2 weeks after study commencement (T1), and at the 4-week follow-up (T2']",['control group (CG) received a brochure about the food pyramid concept and physical activity'],"['knowledge score of IG', 'maintenance of knowledge, application of the DED-P, feelings during game play, game acceptance, and behavioral measures (physical activity, media consumption, and dietary intake', 'dropout rate', 'gain in knowledge (nutrition and stress coping) and measured with a pretested questionnaire', 'behavioral level']","[{'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0034229', 'cui_str': 'Pyramidal tract structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.102248,"The secondary outcomes were the maintenance of knowledge, application of the DED-P, feelings during game play, game acceptance, and behavioral measures (physical activity, media consumption, and dietary intake).
","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Mack', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital, Tübingen, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Reiband', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital, Tübingen, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Etges', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital, Tübingen, Germany.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Eichhorn', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital, Tübingen, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Schaeffeler', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital, Tübingen, Germany.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Zurstiege', 'Affiliation': 'Department of Media Studies Tübingen, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Gawrilow', 'Affiliation': 'Department of School Psychology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weimer', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Ulm University Medical Center, Ulm, Germany.'}, {'ForeName': 'Riyad', 'Initials': 'R', 'LastName': 'Peeraully', 'Affiliation': ""Department of Paediatric Surgery, Nottingham Children's Hospital, Nottingham, United Kingdom.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Teufel', 'Affiliation': 'LVR-Clinic for Psychosomatic Medicine and Psychotherapy, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Blumenstock', 'Affiliation': 'Institute for Clinical Epidemiology and Applied Biometry, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Katrin Elisabeth', 'Initials': 'KE', 'LastName': 'Giel', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital, Tübingen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Junne', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital, Tübingen, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Zipfel', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital, Tübingen, Germany.'}]",Journal of medical Internet research,['10.2196/15725']
248,32252004,Potential applications for rhIGF-I: Bone disease and IGFI.,"Growth hormone (GH) and insulin like growth factor-I (IGFI) are key bone trophic hormones, whose rising levels during puberty are critical for pubertal bone accrual. Conditions of GH deficiency and genetic resistance impact cortical and trabecular bone deleteriously with reduced estimates of bone strength. In humans, conditions of undernutrition (as in anorexia nervosa (AN), or subsequent to chronic illnesses) are associated with low IGF-I levels, which correlate with disease severity, and also with lower bone mineral density (BMD), impaired bone structure and lower strength estimates. In adolescents and adults with AN, studies have demonstrated a nutritionally acquired GH resistance with low IGF-I levels despite high concentrations of GH. IGF-I levels go up with increasing body weight, and are associated with rising levels of bone turnover markers. In short-term studies lasting 6-10 days, recombinant human IGF-I (rhIGF-I) administration in physiologic replacement doses normalized IGF-I levels and increased levels of bone formation markers in both adults and adolescents with AN. In a randomized controlled trial in adults with AN in which participants were randomized to one of four arms: (i) rhIGF-I with oral estrogen-progesterone (EP), (ii) rhIGF-I alone, (iii) EP alone, or (iv) neither for 9 months, a significant increase in bone formation markers was noted in the groups that received rhIGF-I, and a significant decrease in bone resorption markers in the groups that received EP. The group that received both rhIGF-I and EP had a significant increase in bone density at the spine and hip compared to the group that received neither. Side effects were minimal, with no documented fingerstick glucose of <50 mg/dl. These data thus suggest a potential role for rhIGF-I administration in optimizing bone accrual in states of undernutrition associated with low IGF-I.",2020,I and EP had a significant increase in bone density at the spine and hip compared to the group that received neither.,"['adults with AN in which participants', 'adults and adolescents with AN']","['recombinant human IGF-I (rhIGF-I) administration in physiologic replacement', 'rhIGF-I with oral estrogen-progesterone (EP), (ii) rhIGF-I alone, (iii) EP alone', 'rhIGF', 'Growth hormone (GH) and insulin like growth factor-I (IGFI']","['fingerstick glucose', 'bone formation markers', 'bone resorption markers', 'bone strength', 'bone density', 'levels of bone formation markers']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0486261,I and EP had a significant increase in bone density at the spine and hip compared to the group that received neither.,"[{'ForeName': 'Marisol', 'Initials': 'M', 'LastName': 'Bahamonde', 'Affiliation': 'Department of Pediatrics, Universidad San Francisco de Quito (USFQ), Cumbayá, Ecuador.'}, {'ForeName': 'Madhusmita', 'Initials': 'M', 'LastName': 'Misra', 'Affiliation': 'Division of Pediatric Endocrinology, Massachusetts General Hospital for Children, USA; Neuroendocrine Unit, Massachusetts General Hospital, Boston, MA, USA. Electronic address: mmisra@mgh.harvard.edu.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.101317']
249,31923550,Adherence to adding inhaled corticosteroids to rescue therapy in a pragmatic trial with adults with asthma: A pilot study.,"BACKGROUND


Underuse of guideline-recommended inhaled corticosteroids (ICS) controller therapy is a risk factor for greater asthma burden. ICS concomitantly used with rescue inhalers (Patient-Activated Reliever-Triggered ICS ['PARTICS']) reduced asthma exacerbations in efficacy trials, but whether PARTICS is effective in pragmatic trials is unknown.
OBJECTIVE


We conducted this pilot to determine the feasibility of executing a large-scale pragmatic PARTICS trial and to improve study protocols.
METHODS


Four sites recruited 33 Hispanic or black adults with persistent asthma, randomized them approximately 3:1 to intervention or usual care, and followed them for 12 weeks. All participants received asthma guideline-based educational videos; intervention participants received video-based instructions on implementing PARTICS plus usual medications. The study involved 1 randomization visit and monthly questionnaires. Timely questionnaire responses (±2 weeks) were monitored. Participants underwent qualitative phone interviews to assess self-reported adherence to PARTICS and understand barriers to completing study procedures.
RESULTS


Timely questionnaire response rates were 61%, 64%, and 70% at 4, 8, and 12 weeks, respectively. Self-reported adherence to PARTICS was 76% (95% confidence interval [CI], 58%-94% [n = 21]), 88% (95%CI, 72%-100% [n = 16]), and 62% (95%CI, 36%-88% [n = 13]) at weeks 1, 6, and 12, respectively. Barriers to completing study procedures included difficulties with questionnaire access, remembering to use ICS and rescue inhalers together, and obtaining refills. Only 22% of participants recognized their short-acting bronchodilator as ""reliever"" or ""rescue.""
CONCLUSION


Recruitment was feasible within the allocated period. Adherence to PARTICS was incomplete, questionnaire completion was suboptimal, and common rescue inhaler nomenclature usage was limited. We have modified the full study protocol to attempt to improve adherence to PARTICS and minimize barriers to study procedures.
CLINICAL TRIALS REGISTRATION


pilot study for 'PeRson EmPowered Asthma Relief' (PREPARE, NCT02995733).",2020,"Self-reported adherence to PARTICS was 76% [95%CI 58-94%(n=21)], 88% [95%CI 72-100%(n=16)], and 62% [95%CI 36-88%(n=13)] at weeks 1, 6, and 12, respectively.",['Four sites recruited 33 Hispanic or Black persistently asthmatic adults'],"['Inhaled Corticosteroids', ""ICS concomitantly-used with rescue inhalers [Patient-Activated Reliever-Triggered ICS('PARTICS"", 'corticosteroids (ICS) controller therapy', 'asthma guideline-based educational videos; intervention participants received video-based instructions on implementing PARTICS plus usual medications']","['Timely questionnaire responses', 'Timely questionnaire response rates']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.156152,"Self-reported adherence to PARTICS was 76% [95%CI 58-94%(n=21)], 88% [95%CI 72-100%(n=16)], and 62% [95%CI 36-88%(n=13)] at weeks 1, 6, and 12, respectively.","[{'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Cardet', 'Affiliation': 'University of South Florida, Morsani College of Medicine, Division of Allergy and Immunology, Tampa, Florida. Electronic address: jcardet@health.usf.edu.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Busse', 'Affiliation': 'Department of Medicine, Mount Sinai School of Medicine, New York, New York.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Carroll', 'Affiliation': 'Department of Family Medicine, University of Colorado, Denver, Colorado.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Casale', 'Affiliation': 'University of South Florida, Morsani College of Medicine, Division of Allergy and Immunology, Tampa, Florida.'}, {'ForeName': 'Tamera', 'Initials': 'T', 'LastName': 'Coyne-Beasley', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Sherrie', 'Initials': 'S', 'LastName': 'Dixon-Williams', 'Affiliation': 'Center for Clinical Informatics Research and Educations, and the Departments of Internal Medicine, Pediatrics, and Population and Quantitative Health Sciences, The MetroHealth System, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Fagan', 'Affiliation': 'University of Miami Hospital and Clinics, Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Forth', 'Affiliation': ""Brigham and Women's Hospital, Division of Pulmonary and Critical Care Medicine, Boston, Massachusetts.""}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Fuhlbrigge', 'Affiliation': 'Department of Medicine, University of Colorado, Denver, Colorado.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Hernandez', 'Affiliation': 'Division of Allergy, Immunology, and Rheumatology, Department of Pediatrics, University of North Carolina at Chapel Hill. Chapel Hill, North Carolina.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kaelber', 'Affiliation': 'Center for Clinical Informatics Research and Educations, and the Departments of Internal Medicine, Pediatrics, and Population and Quantitative Health Sciences, The MetroHealth System, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Kaplan', 'Affiliation': 'American Lung Association, Chicago, Illinois.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Lorenzi', 'Affiliation': ""Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Madison', 'Affiliation': 'Patient-Centered Outcomes Research Institute, Minneapolis, Minnsesota.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Maher', 'Affiliation': ""Brigham and Women's Hospital, Division of Pulmonary and Critical Care Medicine, Boston, Massachusetts.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Majewski', 'Affiliation': 'Center for Clinical Informatics Research and Educations, and the Departments of Internal Medicine, Pediatrics, and Population and Quantitative Health Sciences, The MetroHealth System, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Manning', 'Affiliation': ""The American Academy of Family Physicians' National Research Network, Leawood, Kansas.""}, {'ForeName': 'Melissa D', 'Initials': 'MD', 'LastName': 'McKee', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Sylvette', 'Initials': 'S', 'LastName': 'Nazario', 'Affiliation': 'Department of Internal Medicine, University of Puerto Rico, San Juan, Puerto Rico.'}, {'ForeName': 'Wilson D', 'Initials': 'WD', 'LastName': 'Pace', 'Affiliation': 'Department of Family Medicine, University of Colorado, Denver, Colorado.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Pencina', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Cynthia S', 'Initials': 'CS', 'LastName': 'Rand', 'Affiliation': 'Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Rodriguez-Louis', 'Affiliation': ""Brigham and Women's Hospital, Division of Pulmonary and Critical Care Medicine, Boston, Massachusetts.""}, {'ForeName': 'Lilin', 'Initials': 'L', 'LastName': 'She', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Shields', 'Affiliation': ""The American Academy of Family Physicians' National Research Network, Leawood, Kansas.""}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Teng', 'Affiliation': ""Brigham and Women's Hospital, Division of Pulmonary and Critical Care Medicine, Boston, Massachusetts.""}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Wechsler', 'Affiliation': 'Department of Medicine, National Jewish Health, Denver, Colorado.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Wisnivesky', 'Affiliation': 'Department of Medicine, Mount Sinai School of Medicine, New York, New York.'}, {'ForeName': 'Barbara P', 'Initials': 'BP', 'LastName': 'Yawn', 'Affiliation': 'Department of Family Medicine, University of Minnesota, Blaine, Minnesota.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': ""Brigham and Women's Hospital, Division of Pulmonary and Critical Care Medicine, Boston, Massachusetts.""}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2019.12.027']
250,31309919,Long-term vitamin D and high-dose  n -3 fatty acids' supplementation improve markers of cardiometabolic risk in type 2 diabetic patients with CHD.,"This study was performed to evaluate the effects of vitamin D and n-3 fatty acids' co-supplementation on markers of cardiometabolic risk in diabetic patients with CHD. This randomised, double-blinded, placebo-controlled trial was conducted among sixty-one vitamin D-deficient diabetic patients with CHD. At baseline, the range of serum 25-hydroxyvitamin D levels in study participants was 6·3-19·9 ng/ml. Subjects were randomly assigned into two groups either taking 50 000 IU vitamin D supplements every 2 weeks plus 2× 1000 mg/d n-3 fatty acids from flaxseed oil (n 30) or placebo (n 31) for 6 months. Vitamin D and n-3 fatty acids' co-supplementation significantly reduced mean (P = 0·01) and maximum levels of left carotid intima-media thickness (CIMT) (P = 0·004), and mean (P = 0·02) and maximum levels of right CIMT (P = 0·003) compared with the placebo. In addition, co-supplementation led to a significant reduction in fasting plasma glucose (β -0·40 mmol/l; 95 % CI -0·77, -0·03; P = 0·03), insulin (β -1·66 μIU/ml; 95 % CI -2·43, -0·89; P < 0·001), insulin resistance (β -0·49; 95 % CI -0·72, -0·25; P < 0·001) and LDL-cholesterol (β -0·21 mmol/l; 95 % CI -0·41, -0·01; P = 0·04), and a significant increase in insulin sensitivity (β +0·008; 95 % CI 0·004, 0·01; P = 0·001) and HDL-cholesterol (β +0·09 mmol/l; 95 % CI 0·01, 0·17; P = 0·02) compared with the placebo. Additionally, high-sensitivity C-reactive protein (β -1·56 mg/l; 95 % CI -2·65, -0·48; P = 0·005) was reduced in the supplemented group compared with the placebo group. Overall, vitamin D and n-3 fatty acids' co-supplementation had beneficial effects on markers of cardiometabolic risk.",2019,"' co-supplementation significantly reduced mean (P = 0·01) and maximum levels of left carotid intima-media thickness (CIMT) (P = 0·004), and mean (P = 0·02) and maximum levels of right CIMT (P = 0·003) compared with the placebo.","['0·17', 'type 2 diabetic patients with CHD', 'diabetic patients with CHD', 'sixty-one vitamin D-deficient diabetic patients with CHD']","['n-3 fatty acids from flaxseed oil (n 30) or placebo', 'placebo', ""Long-term vitamin D and high-dose n-3 fatty acids' supplementation"", ""vitamin D and n-3 fatty acids' co-supplementation"", 'Vitamin D and n-3 fatty acids', 'IU vitamin D supplements']","['HDL-cholesterol', 'maximum levels of left carotid intima-media thickness (CIMT', 'LDL-cholesterol', 'insulin sensitivity', 'cardiometabolic risk', 'insulin resistance', 'fasting plasma glucose', 'maximum levels of right CIMT', 'range of serum 25-hydroxyvitamin D levels']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0023754', 'cui_str': 'flaxseed oil'}, {'cui': 'C0632490', 'cui_str': 'N 30'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C3541352', 'cui_str': 'Vitamin D supplement (substance)'}]","[{'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}]",61.0,0.769996,"' co-supplementation significantly reduced mean (P = 0·01) and maximum levels of left carotid intima-media thickness (CIMT) (P = 0·004), and mean (P = 0·02) and maximum levels of right CIMT (P = 0·003) compared with the placebo.","[{'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Talari', 'Affiliation': 'Department of Radiology, Kashan University of Medical Sciences, Kashan, I.R. Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Najafi', 'Affiliation': 'Department of Radiology, Kashan University of Medical Sciences, Kashan, I.R. Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Raygan', 'Affiliation': 'Department of Cardiology, School of Medicine, Kashan University of Medical Sciences, Kashan, I.R. Iran.'}, {'ForeName': 'Naghmeh', 'Initials': 'N', 'LastName': 'Mirhosseini', 'Affiliation': 'School of Public Health, University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'Vahidreza', 'Initials': 'V', 'LastName': 'Ostadmohammadi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran.'}, {'ForeName': 'Elaheh', 'Initials': 'E', 'LastName': 'Amirani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Taghizadeh', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hajijafari', 'Affiliation': 'Trauma Research Center, Kashan University of Medical Sciences, Kashan, I.R. Iran.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Shafabakhsh', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran.'}]",The British journal of nutrition,['10.1017/S0007114519001132']
251,32189042,Varied movement errors drive learning of dynamic balance control during walking in people with incomplete spinal cord injury: a pilot study.,"The purpose of this study was to determine whether the application of a varied pelvis perturbation force would improve dynamic balance control and gait stability of people with incomplete spinal cord injury (iSCI). Fourteen participants with iSCI completed the test in two conditions, i.e., walking paired with pelvis perturbation force and treadmill walking only, with 1-week interval in between. The order of the testing condition was randomized across participants. For the pelvis pertubation condition, subjects walked on a treadmill with no force for 1 min, with a varied pelvis perturbation force that was bilaterally applied in the medial-lateral direction for 10 min, without force for 1 min, and then with the perturbation for another 10 min after a sitting break. For the treadmill only condition, a protocol that was similar to the perturbation condition was used but no force was applied. Margin of stability (MoS), weight shifting, and other spatiotemporal gait parameters were calculated. Compared to treadmill training only, participants showed significant smaller MoS and double-leg support time after treadmill walking with pelvis perturbation. In addition, participants showed significantly greater improvements in overground walking speed after treadmill walking with pelvis perturbation than treadmill only (p = 0.021). Results from this study suggest that applying a varied pelvis perturbation force during treadmill walking could improve dynamic balance control in people with iSCI, which could be transferred to overground walking. These findings may be used to develop a new intervention to improve balance and walking function in people with iSCI.",2020,"Compared to treadmill training only, participants showed significant smaller MoS and double-leg support time after treadmill walking with pelvis perturbation.","['people with incomplete spinal cord injury (iSCI', 'people with iSCI', 'people with incomplete spinal cord injury', 'Fourteen participants with iSCI']","['treadmill training', 'Varied movement errors drive learning of dynamic balance control during walking']","['overground walking speed', 'dynamic balance control', 'dynamic balance control and gait stability', 'smaller MoS and double-leg support time', 'Margin of stability (MoS), weight shifting, and other spatiotemporal gait parameters']","[{'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury (disorder)'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",14.0,0.0682445,"Compared to treadmill training only, participants showed significant smaller MoS and double-leg support time after treadmill walking with pelvis perturbation.","[{'ForeName': 'Jui-Te', 'Initials': 'JT', 'LastName': 'Lin', 'Affiliation': 'Legs and Walking Lab, Shirley Ryan AbilityLab, 355 East Erie Street, 23rd Floor, Chicago, IL, 60611, USA.'}, {'ForeName': 'Chao-Jung', 'Initials': 'CJ', 'LastName': 'Hsu', 'Affiliation': 'Legs and Walking Lab, Shirley Ryan AbilityLab, 355 East Erie Street, 23rd Floor, Chicago, IL, 60611, USA.'}, {'ForeName': 'Weena', 'Initials': 'W', 'LastName': 'Dee', 'Affiliation': 'Legs and Walking Lab, Shirley Ryan AbilityLab, 355 East Erie Street, 23rd Floor, Chicago, IL, 60611, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Legs and Walking Lab, Shirley Ryan AbilityLab, 355 East Erie Street, 23rd Floor, Chicago, IL, 60611, USA.'}, {'ForeName': 'W Zev', 'Initials': 'WZ', 'LastName': 'Rymer', 'Affiliation': 'Legs and Walking Lab, Shirley Ryan AbilityLab, 355 East Erie Street, 23rd Floor, Chicago, IL, 60611, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Legs and Walking Lab, Shirley Ryan AbilityLab, 355 East Erie Street, 23rd Floor, Chicago, IL, 60611, USA. w-ming@northwestern.edu.'}]",Experimental brain research,['10.1007/s00221-020-05776-0']
252,32330594,Pilot study of combined aerobic and resistance exercise on fatigue for patients with head and neck cancer: Inflammatory and epigenetic changes.,"This pilot study examined whether a combined aerobic resistance exercise program reduced fatigue and the potential inflammatory and epigenetic mechanisms in patients with head and neck cancer (HNC) receiving intensity-modulated radiotherapy. The exercise group (N = 12) received a 3-month supervised aerobic resistance exercise intervention that was initiated before a 6-week radiotherapy regimen; the control group (N = 14) received standard care. Fatigue was measured using Multidimensional Fatigue Inventory-20; physical function measures included a 6-minute walk distance (6MWD), chair stands, bicep curls, and hand grip strength. Inflammatory markers and DNA methylation data were acquired using standardized protocol. Patients were mostly white (93%) and male (81%) with a mean age of 57 years. At the end of the intervention, the exercise group had a marginal decrease in fatigue compared with the control (-5.0 vs. 4.9; P = 0.10). The exercise group had a significantly greater improvement in 6MWD (29.8 vs. -55.5 m; P = 0.04), and a marginally smaller decline in hand grip (-0.3 vs. -5.8 lbs; P = 0.05) at the end of the intervention than the control. No significant difference in inflammatory markers was observed between groups. Lower plasma interleukin (IL) 6, IL1 receptor antagonist, tumor necrosis factor α (TNFα), soluble TNF receptor II and C-reactive protein were significantly associated with increased 6MWD, chair stand, and bicep curl at the end of the intervention (p < 0.05). Among the 1152 differentially methylated sites (DMS) after intervention (p < 0.001), 163 DMS were located in gene promoter regions. Enrichment analysis suggested that the top 10 upstream regulators were associated with tumor (HNF4A, RPP38, HOXA9, SAHM1, CDK7, NDN, RPS15) and inflammation (IRF7, CRKL, ONECUT1). The top 5 diseases or functions annotations of the 62 hypermethylated DMS indicated anti-tumor and anti-inflammatory effects that might be linked to exercise. These findings suggest that exercise may improve physical performance and reduce fatigue, which could be further linked to decreased inflammation, during active radiotherapy for HNC patients. Larger studies are warranted.",2020,"Lower plasma interleukin (IL) 6, IL1 receptor antagonist, tumor necrosis factor α (TNFα), soluble TNF receptor II and C-reactive protein were significantly associated with increased 6MWD, chair stand, and bicep curl at the end of the intervention (p<0.05).","['Patients were mostly white (93%) and male (81%) with a mean age of 57 years', 'Patients with Head and Neck Cancer', 'patients with head and neck cancer (HNC) receiving intensity-modulated radiotherapy']","['supervised aerobic resistance exercise intervention', 'Combined Aerobic and Resistance Exercise', 'combined aerobic resistance exercise program', 'standard care']","['6MWD, chair stand, and bicep curl', '6-minute walk distance (6MWD), chair stands, bicep curls, and hand grip strength', 'inflammatory markers', 'Lower plasma interleukin (IL) 6, IL1 receptor antagonist, tumor necrosis factor α (TNFα), soluble TNF receptor II and C-reactive protein', 'fatigue and the potential inflammatory and epigenetic mechanisms', 'Fatigue', '6MWD', 'physical performance and reduce fatigue', 'fatigue', 'tumor (HNF4A, RPP38, HOXA9, SAHM1, CDK7, NDN, RPS15) and inflammation (IRF7, CRKL, ONECUT1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0063710', 'cui_str': 'Interleukin 1 Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0077503', 'cui_str': 'Tumor Necrosis Factor Receptor'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1516924', 'cui_str': 'Epigenetic Process'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0386322', 'cui_str': 'Hoxa9 protein'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1530281', 'cui_str': 'IRF7 protein, human'}, {'cui': 'C0219488', 'cui_str': 'CRKL protein'}]",163.0,0.0291941,"Lower plasma interleukin (IL) 6, IL1 receptor antagonist, tumor necrosis factor α (TNFα), soluble TNF receptor II and C-reactive protein were significantly associated with increased 6MWD, chair stand, and bicep curl at the end of the intervention (p<0.05).","[{'ForeName': 'Canhua', 'Initials': 'C', 'LastName': 'Xiao', 'Affiliation': 'School of Nursing, Yale University, 400 West Campus Drive, Orange 06477, United States. Electronic address: canhua.xiao@yale.edu.'}, {'ForeName': 'Jonathan J', 'Initials': 'JJ', 'LastName': 'Beitler', 'Affiliation': 'Department of Radiation, School of Medicine, Emory University, 1520 Clifton Road NE, Atlanta 30322, United States.'}, {'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Higgins', 'Affiliation': 'Department of Radiation, School of Medicine, Emory University, 1520 Clifton Road NE, Atlanta 30322, United States.'}, {'ForeName': 'Cynthia E', 'Initials': 'CE', 'LastName': 'Chico', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, 1365-B Clifton Road, Atlanta, GA 30322, United States.'}, {'ForeName': 'Janice S', 'Initials': 'JS', 'LastName': 'Withycombe', 'Affiliation': ""School of Nursing, Clemson University, 508 Edward's, Clemson, SC 29634, United States.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'State Key Laboratory of Medical Neurobiology and MOE Frontier Center for Brain Science, Institutes of Brain Science, Fudan University, Shanghai 200433, China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Epidemiology and Public Health, School of Medicine, Yale University, 300 George Street, New Haven, CT 06510, United States.'}, {'ForeName': 'I-Hsin', 'Initials': 'IH', 'LastName': 'Lin', 'Affiliation': 'Yale Center for Analytical Sciences, School of Public Health, Yale University, 300 George Street, New Haven, CT 06510, United States.'}, {'ForeName': 'Fangyong', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'School of Public Health, Yale University, 60 College St, New Haven, CT 06510, United States.'}, {'ForeName': 'Sangchoon', 'Initials': 'S', 'LastName': 'Jeon', 'Affiliation': 'School of Nursing, Yale University, 400 West Campus Drive, Orange 06477, United States.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Irwin', 'Affiliation': 'School of Public Health, Yale University, 60 College St, New Haven, CT 06510, United States.'}, {'ForeName': 'Deborah W', 'Initials': 'DW', 'LastName': 'Bruner', 'Affiliation': 'School of Nursing, Emory University, 1520 Clifton Road NE, Atlanta 30322, United States.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, 1365-B Clifton Road, Atlanta, GA 30322, United States.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Gary', 'Affiliation': 'School of Nursing, Emory University, 1520 Clifton Road NE, Atlanta 30322, United States.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2020.04.044']
253,32298704,Pain-modulating effects of oxytocin in patients with chronic low back pain.,"The neuropeptide oxytocin (OT) has been shown to play a modulatory role in nociception. However, analgesic effects of OT in chronic pain conditions remain elusive and the neural underpinnings have not yet been investigated in humans. Here, we conducted an exploratory, randomized, placebo-controlled, cross-over study to examine effects of intranasal OT in male patients suffering from chronic low back pain (CBP) versus healthy controls (HC). N = 22 participants with CBP and 22 HCs were scanned using functional magnetic resonance imaging (fMRI) while they continuously rated either spontaneously occurring back pain or acute thermal pain stimuli applied to the lower back. During heat pain processing we found that OT versus PL attenuated pain intensity ratings and increased BOLD responses in the caudate nucleus of the striatum in CBP versus HCs. Spontaneously experienced pain in contrast to heat pain was associated with activation changes in the medial frontal cortex (MFC) and the anterior cingulate cortex (ACC) as reported in previous studies. However, we did not observe OT effects on spontaneously experienced pain in CBP patients. Overall, our preliminary data may suggest that the striatum is a key structure underlying the pain-modulating effects of OT in patients with chronic pain and adds to the growing evidence linking the neuropeptide to pain modulation in humans. Further studies on neuronal OT effects in larger samples of chronic back pain patients are needed to understand probable mechanisms of OT effects in chronic pain.",2020,During heat pain processing we found that OT versus PL attenuated pain intensity ratings and increased BOLD responses in the caudate nucleus of the striatum in CBP versus HCs.,"['N\u202f=\u202f22 participants with CBP and 22\u202fHCs', 'male patients suffering from chronic low back pain (CBP) versus healthy controls (HC', 'patients with chronic low back pain', 'chronic back pain patients', 'patients with chronic pain']","['neuropeptide oxytocin (OT', 'OT', 'OT versus PL', 'intranasal OT', 'placebo', 'functional magnetic resonance imaging (fMRI) while they continuously rated either spontaneously occurring back pain or acute thermal pain stimuli applied to the lower back', 'oxytocin']","['BOLD responses', 'pain intensity ratings', 'medial frontal cortex (MFC) and the anterior cingulate cortex (ACC', 'OT effects']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0032052', 'cui_str': 'Human placental lactogen'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0004600', 'cui_str': 'Back'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",22.0,0.105867,During heat pain processing we found that OT versus PL attenuated pain intensity ratings and increased BOLD responses in the caudate nucleus of the striatum in CBP versus HCs.,"[{'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Boll', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Ueltzhoeffer', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Roth', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Bertsch', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Germany; Department of Psychology and Psychotherapy, Ludwigs-Maximilian-University München, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Department of Cognitive and Clinical Neuroscience, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Frauke', 'Initials': 'F', 'LastName': 'Nees', 'Affiliation': 'Department of Cognitive and Clinical Neuroscience, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Valery', 'Initials': 'V', 'LastName': 'Grinevich', 'Affiliation': 'Department of Neuropeptide Research in Psychiatry, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Sabine C', 'Initials': 'SC', 'LastName': 'Herpertz', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Germany. Electronic address: Sabine.Herpertz@med.uni-heidelberg.de.'}]",Neuropharmacology,['10.1016/j.neuropharm.2020.108105']
254,32302646,Acute stress affects implicit but not explicit motor imagery: A pilot study.,"Motor imagery (MI) is the capacity to mentally perform one or a set of movements without concomitant overt action. MI training has been show to enhance the subsequent motor performance. While the benefits of MI to manage stress have been extensively documented, the reverse impact of stress on MI received far less attention. The present study thus aimed to evaluate whether acute stress might influence MI abilities. Thirty participants were assigned either to a stress or a control group. The Socially Evaluated Cold Pressor Test (SECPT) was used to induce stress, with heart rate, electrodermal activity, salivary cortisol, and self-report perceived levels of stress being monitored during the experiment. Stress induction was followed by both implicit (laterality judgment) and explicit (sequential pointing) MI tasks. Main results showed a deleterious impact of stress on implicit MI, while explicit MI was not altered. These exploratory findings provide a deeper understanding of stress effects on cognition, and practically support that under stressful conditions, as during a sport competition or rehabilitation contexts, explicit MI should be prioritized.",2020,"Main results showed a deleterious impact of stress on implicit MI, while explicit MI was not altered.",['Thirty participants'],"['explicit motor imagery', 'Motor imagery (MI', 'MI training']","['induce stress, with heart rate, electrodermal activity, salivary cortisol, and self-report perceived levels of stress', 'deleterious impact of stress on implicit MI, while explicit MI']","[{'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}]",30.0,0.0137573,"Main results showed a deleterious impact of stress on implicit MI, while explicit MI was not altered.","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Schlatter', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, 69 622 Villeurbanne, France. Electronic address: sophie.schlatter@univ-lyon1.fr.'}, {'ForeName': 'Aymeric', 'Initials': 'A', 'LastName': 'Guillot', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, 69 622 Villeurbanne, France. Electronic address: aymeric.guillot@univ-lyon1.fr.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Faes', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, 69 622 Villeurbanne, France. Electronic address: camille.faes@univ-lyon1.fr.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Saruco', 'Affiliation': 'Neurologische Universitätsklinik, Bergmannsheil gGmbH, Forschungsgruppe Plastizität, Bürkle-de-la-Camp-Platz 1, 44789 Bochum, Germany. Electronic address: elodie.saruco@ruhr-uni-bochum.de.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Collet', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, 69 622 Villeurbanne, France. Electronic address: christian.collet@univ-lyon1.fr.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Di Rienzo', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, 69 622 Villeurbanne, France. Electronic address: franck.di-rienzo@univ-lyon1.fr.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Debarnot', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, 69 622 Villeurbanne, France. Electronic address: ursula.debarnot@univ-lyon1.fr.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.04.011']
255,32194219,Sitagliptin improves plasma apolipoprotein profile in type 2 diabetes: A randomized clinical trial of sitagliptin effect on lipid and glucose metabolism (SLIM) study.,"AIM


This study aims to evaluate the effect of dipeptidyl peptidase-4 inhibitors on lipid metabolism in patients with type 2 diabetes mellitus (T2D).
METHODS


This is a multicenter, open-labeled, randomized controlled study. T2D patients with HbA1c 6.9-8.9% (52-74 mmol/mol) who were under treatment with sulfonylurea were randomly allocated to either the sitagliptin group or the non-sitagliptin group. Glucose and lipid metabolism parameters including apolipoproteins (apo), sterols, and urinary albumin were assessed at baseline, 3, and 6 months of the treatment.
RESULTS


A total of 164 patients completed the 6-month observation (n = 81 for sitagliptin and n = 83 for non-sitagliptin). HbA1c decreased in the sitagliptin group but not in the non-sitagliptin group. Serum TG and total, LDL and HDL cholesterol levels did not change in either group. Apo B-48, apo CII, and apo CIII levels decreased in the sitagliptin group, but not in the non-sitagliptin group. The change in urinary albumin was significantly different between the groups with a preferable change in the sitagliptin group. There were no changes in serum sterols levels in the two groups.
CONCLUSIONS


The treatment of sitagliptin for 6 months improves the metabolism of glucose and chylomicron and reduces plasma levels of atherogenic lipoproteins in patients with T2D.",2020,"Apo B-48, apo CII, and apo CIII levels decreased in the sitagliptin group, but not in the non-sitagliptin group.","['patients with T2D', '164 patients completed the 6-month observation (n=81 for sitagliptin and n=83 for non-sitagliptin', 'Type 2 Diabetes', 'T2D patients with HbA1c 6.9-8.9% (52-74 mmol/mol) who were under treatment with sulfonylurea', 'patients with type 2 diabetes mellitus (T2D']","['dipeptidyl peptidase-4 inhibitors', 'sitagliptin group or the non-sitagliptin group', 'Sitagliptin']","['Apo B-48, apo CII, and apo CIII levels', 'change in urinary albumin', 'HbA1c', 'serum sterols levels', 'metabolism of glucose and chylomicron and reduces plasma levels of atherogenic lipoproteins', 'lipid metabolism', 'Plasma Apolipoprotein Profile', 'Serum TG and total, LDL and HDL cholesterol levels', 'Glucose and lipid metabolism parameters including apolipoproteins (apo), sterols, and urinary albumin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea Compounds'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0103839', 'cui_str': 'Chylomicron Apo B'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0038323', 'cui_str': 'Sterols'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0008731', 'cui_str': 'Chylomicrons'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0523476', 'cui_str': 'Apolipoprotein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",164.0,0.028987,"Apo B-48, apo CII, and apo CIII levels decreased in the sitagliptin group, but not in the non-sitagliptin group.","[{'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Tanimura-Inagaki', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Mototsugu', 'Initials': 'M', 'LastName': 'Nagao', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Harada', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Sugihara', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Moritani', 'Affiliation': 'Moritani Clinic, Tokyo, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Sasaki', 'Affiliation': 'International University of Health and Welfare, Fukuoka, Japan.'}, {'ForeName': 'Suminori', 'Initials': 'S', 'LastName': 'Kono', 'Affiliation': 'MedStatCorporation, Fukuoka, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Oikawa', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan; Fukujuji Hospital, Tokyo, Japan. Electronic address: shinichi@nms.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108119']
256,31864728,High-Flow Nasal Cannula Versus Conventional Oxygen Therapy in Relieving Dyspnea in Emergency Palliative Patients With Do-Not-Intubate Status: A Randomized Crossover Study.,"STUDY OBJECTIVE


Palliative patients often visit the emergency department (ED) with respiratory distress during their end-of-life period. The goal of management is alleviating dyspnea and providing comfort. High-flow nasal cannula may be an alternative oxygen-delivering method for palliative patients with do-not-intubate status. We therefore aim to compare the efficacy of high-flow nasal cannula with conventional oxygen therapy in improving dyspnea of palliative patients with do-not-intubate status who have hypoxemic respiratory failure in the ED.
METHODS


This randomized, nonblinded, crossover study was conducted with 48 palliative patients aged 18 years or older with do-not-intubate status who presented with hypoxemic respiratory failure to the ED of Siriraj Hospital, Bangkok, Thailand. The participants were randomly allocated to conventional oxygen therapy for 60 minutes, followed by high-flow nasal cannula for 60 minutes (n=24) or vice versa (n=24). The primary outcome was modified Borg scale score. The secondary outcomes were numeric rating scale score of dyspnea and vital signs.
RESULTS


Intention-to-treat analysis included 44 patients, 22 in each group. Baseline mean modified Borg scale score was 7.6 (SD 2.2) (conventional oxygen therapy first) and 8.2 (SD 1.8) (high-flow nasal cannula first). At 60 minutes, mean modified Borg scale score in patients receiving conventional oxygen therapy and high-flow nasal cannula was 4.9 (standard of mean 0.3) and 2.9 (standard of mean 0.3), respectively (mean difference 2.0; 95% confidence interval 1.4 to 2.6). Results for the numeric rating scale score of dyspnea were similar to those for the modified Borg scale score. Respiratory rates were lower with high-flow nasal cannula (mean difference 5.9; 95% confidence interval 3.5 to 8.3), and high-flow nasal cannula was associated with a significantly lower first-hour morphine dose.
CONCLUSION


High-flow nasal cannula was superior to conventional oxygen therapy in reducing the severity of dyspnea in the first hour of treatment in patients with do-not-intubate status and hypoxemic respiratory failure.",2020,"Respiratory rates were lower with high-flow nasal cannula (mean difference 5.9; 95% confidence interval 3.5 to 8.3), and high-flow nasal cannula was associated with a significantly lower first-hour morphine dose.
","['48 palliative patients aged 18 years or older with do-not-intubate status who presented with hypoxemic respiratory failure to the ED of Siriraj Hospital, Bangkok, Thailand', 'Palliative patients often visit the emergency department (ED) with respiratory distress during their end-of-life period', 'palliative patients with do-not-intubate status who have hypoxemic respiratory failure in the ED', 'Emergency Palliative Patients', 'palliative patients with do-not-intubate status']","['High-flow nasal cannula was superior to conventional oxygen therapy', 'conventional oxygen therapy', 'High-Flow Nasal Cannula Versus Conventional Oxygen Therapy', 'high-flow nasal cannula with conventional oxygen therapy']","['numeric rating scale score of dyspnea', 'Respiratory rates', 'severity of dyspnea', 'modified Borg scale score', 'high-flow nasal cannula', 'mean modified Borg scale score', 'Baseline mean modified Borg scale score', 'numeric rating scale score of dyspnea and vital signs']","[{'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0340194', 'cui_str': 'Respiratory failure without hypercapnia (disorder)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress (finding)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}]","[{'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449399', 'cui_str': 'Borg scale (assessment scale)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0518766'}]",44.0,0.192428,"Respiratory rates were lower with high-flow nasal cannula (mean difference 5.9; 95% confidence interval 3.5 to 8.3), and high-flow nasal cannula was associated with a significantly lower first-hour morphine dose.
","[{'ForeName': 'Onlak', 'Initials': 'O', 'LastName': 'Ruangsomboon', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Thawonrat', 'Initials': 'T', 'LastName': 'Dorongthom', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Tipa', 'Initials': 'T', 'LastName': 'Chakorn', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand. Electronic address: tipa102@yahoo.com.'}, {'ForeName': 'Apichaya', 'Initials': 'A', 'LastName': 'Monsomboon', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Nattakarn', 'Initials': 'N', 'LastName': 'Praphruetkit', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chok', 'Initials': 'C', 'LastName': 'Limsuwat', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Usapan', 'Initials': 'U', 'LastName': 'Surabenjawong', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sattha', 'Initials': 'S', 'LastName': 'Riyapan', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Tanyaporn', 'Initials': 'T', 'LastName': 'Nakornchai', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Wansiri', 'Initials': 'W', 'LastName': 'Chaisirin', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2019.09.009']
257,32172171,PSA and VIM DBS efficiency in essential tremor depends on distance to the dentatorubrothalamic tract.,"OBJECTIVE


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


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


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


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


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


PSA contacts were closer to the DRTT (p = 0.019) and led to a greater improvement in TRS hemi-scores (p = 0.005) than VIM contacts.","[{'ForeName': 'Till A', 'Initials': 'TA', 'LastName': 'Dembek', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany. Electronic address: till.dembek@uk-koeln.de.'}, {'ForeName': 'Jan Niklas', 'Initials': 'JN', 'LastName': 'Petry-Schmelzer', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Reker', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Wirths', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Stereotactic and Functional Neurosurgery, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hamacher', 'Affiliation': 'University of Cologne, Institute of Medical Statistics and Computational Biology, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Steffen', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany.'}, {'ForeName': 'Haidar S', 'Initials': 'HS', 'LastName': 'Dafsari', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany.'}, {'ForeName': 'Mauritius', 'Initials': 'M', 'LastName': 'Hövels', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Stereotactic and Functional Neurosurgery, Germany.'}, {'ForeName': 'Gereon R', 'Initials': 'GR', 'LastName': 'Fink', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany; Cognitive Neuroscience, Institute of Neuroscience and Medicine (INM-3), Research Center Jülich, Jülich, Germany.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Visser-Vandewalle', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Stereotactic and Functional Neurosurgery, Germany.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Barbe', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102235']
258,32249950,"Efficacy of electrical stimulation of denervated muscle: A multicenter, double-blind, randomized clinical trial.","BACKGROUND


This was a multicenter, double-blind, randomized clinical trial to investigate the efficacy of electrical stimulation of denervated muscle (ESDM) on recovery of patients with peripheral nerve injuries.
METHODS


We enrolled 38 patients with traumatic peripheral nerve injuries with axonal damage and clinical impairment of two muscles, who were randomly treated with real or sham electrical stimulation (ES). Clinical and neurophysiological examinations were performed before treatment, at the end of treatment, and 3 mo posttreatment, by the same physician who was blinded to the ES allocation.
RESULTS


All patients improved but there was no significant beneficial effect of ESDM compared with sham treatment.
CONCLUSIONS


This study failed to demonstrate the efficacy of ESDM for peripheral nerve injuries. However, given the large number of variables related to ES and the heterogeneity in disease etiologies and clinical manifestations, future studies on homogeneous populations using different stimulation protocols may be useful.",2020,"All patients improved but there was no significant beneficial effect of ESDM compared to sham treatment.
","['denervated muscle', 'patients with peripheral nerve injuries', '38 patients with traumatic peripheral nerve injuries with axonal damage and clinical impairment of two muscles, who were randomly treated with']","['ESDM', 'electrical stimulation', 'electrical stimulation of denervated muscle (ESDM', 'real or sham electrical stimulation (ES']",[],"[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262593', 'cui_str': 'Injury of peripheral nerve'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]",[],38.0,0.408084,"All patients improved but there was no significant beneficial effect of ESDM compared to sham treatment.
","[{'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Piccinini', 'Affiliation': 'Fondazione Policlinico Universitario A, Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cuccagna', 'Affiliation': 'Fondazione Policlinico Universitario A, Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Caliandro', 'Affiliation': 'Fondazione Policlinico Universitario A, Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Coraci', 'Affiliation': 'Fondazione Policlinico Universitario A, Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Germanotta', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.'}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Pecchioli', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Milan, Taly.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Padua', 'Affiliation': 'Fondazione Policlinico Universitario A, Gemelli IRCCS, Rome, Italy.'}]",Muscle & nerve,['10.1002/mus.26880']
259,32330694,Loading modality and age influence teriparatide-induced bone formation in the human femoral neck.,"Teriparatide (TPTD) reduces risk of both vertebral and nonvertebral fracture, but increases bone mineral density (BMD) much more at the spine than the hip. TPTD and mechanical loading may have a synergistic anabolic effect on BMD, which may help explain these site-specific differences. Under normal daily activity, the femoral neck (FN) is under bending, placing one side under tension and the other under compression. We sought to further understand the relationship between mechanical loading and TPTD at the hip by investigating the effect of tensile versus compressive loading on TPTD stimulated bone formation indices in the human FN. Thirty-eight patients receiving total hip replacements for osteoarthritis were randomized to receive placebo (PBO) or TPTD for a mean treatment duration of 6 weeks prior to surgery, and double tetracycline labeling was administered to allow assessment of bone formation. The FN was harvested during surgery and analyzed for dynamic bone formation indices in the compressive and tensile regions of the endocortical and periosteal envelopes. Regression models relating outcome measures to patient characteristics including sex, age, body weight, and FN geometry were also analyzed. Overall, bone formation was higher with TPTD versus placebo on the endocortical surface, but not the periosteal surface. The level of bone formation in both TPTD and placebo groups was greater on the tensile endocortical surface and the compressive periosteal surface. There was a trend toward decreased endocortical eroded surface with TPTD in the compressive but not the tensile region. Patient age and sex explained the greatest variability in endocortical bone formation, and patient body mass and sex explained the greatest variability in periosteal bone formation. Our data represent the first dynamic comparison of teriparatide treatment under two loading modalities in human FN samples. Future work could determine whether specific hip loading intervention could amplify the benefits of teriparatide on the hip in clinical settings.",2020,"Overall, bone formation was higher with TPTD versus placebo on the endocortical surface, but not the periosteal surface.","['Thirty-eight patients receiving total hip replacements for osteoarthritis', 'human femoral neck', 'human FN']","['teriparatide', 'TPTD versus placebo', 'placebo', 'tetracycline labeling', 'teriparatide-induced bone formation', 'Teriparatide (TPTD', 'placebo (PBO) or TPTD']","['level of bone formation', 'bone mineral density (BMD', 'tensile endocortical surface', 'bone formation', 'patient characteristics including sex, age, body weight, and FN geometry']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039644', 'cui_str': 'Tetracycline'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0449829', 'cui_str': 'Geometry'}]",38.0,0.027878,"Overall, bone formation was higher with TPTD versus placebo on the endocortical surface, but not the periosteal surface.","[{'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Rooney', 'Affiliation': 'Nancy E. and Peter C. Meinig School of Biomedical Engineering, Cornell University, 101 Weill Hall, Ithaca, NY 14853, USA. Electronic address: amr427@cornell.edu.'}, {'ForeName': 'Mathias P G', 'Initials': 'MPG', 'LastName': 'Bostrom', 'Affiliation': 'Research Division, Hospital for Special Surgery, 515 East 71st St., New York, NY 10021, USA. Electronic address: BostromM@hss.edu.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dempster', 'Affiliation': 'Regional Bone Center, Helen Hayes Hospital, 55 N Route 9W, West Haverstraw, NY 10993, USA; Department of Pathology, Columbia University, 630 West 168th St., New York, NY 10025, USA.'}, {'ForeName': 'Jeri W', 'Initials': 'JW', 'LastName': 'Nieves', 'Affiliation': 'Research Division, Hospital for Special Surgery, 515 East 71st St., New York, NY 10021, USA; Regional Bone Center, Helen Hayes Hospital, 55 N Route 9W, West Haverstraw, NY 10993, USA; Department of Epidemiology, Columbia University, 722 West 168th St., New York, NY 10032, USA. Electronic address: jwn5@cumc.columbia.edu.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Regional Bone Center, Helen Hayes Hospital, 55 N Route 9W, West Haverstraw, NY 10993, USA. Electronic address: zhouh@helenhayeshosp.org.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Cosman', 'Affiliation': 'Department of Medicine, Columbia University, 622 West 168th St., New York, NY 10032, USA. Electronic address: fc14@cumc.columbia.edu.'}]",Bone,['10.1016/j.bone.2020.115373']
260,31738014,"Transcutaneous Electrical Nerve Stimulation Reduces Movement-Evoked Pain and Fatigue: A Randomized, Controlled Trial.","OBJECTIVE


Fibromyalgia (FM) is characterized by pain and fatigue, particularly during physical activity. Transcutaneous electrical nerve stimulation (TENS) activates endogenous pain inhibitory mechanisms. This study was undertaken to investigate if using TENS during activity would improve movement-evoked pain and other patient-reported outcomes in women with FM.
METHODS


Participants were randomly assigned to receive active TENS (n = 103), placebo TENS (n = 99), or no TENS (n = 99) and instructed to use it at home during activity 2 hours each day for 4 weeks. TENS was applied to the lumbar and cervicothoracic regions using a modulated frequency (2-125 Hz) at the highest tolerable intensity. Participants rated movement-evoked pain (primary outcome measure) and fatigue on an 11-point scale before and during application of TENS. The primary outcome measure and secondary patient-reported outcomes were assessed at baseline (time of randomization) and at 4 weeks.
RESULTS


After 4 weeks, a greater reduction in movement-evoked pain was reported in the active TENS group versus the placebo TENS group (group mean difference -1.0 [95% confidence interval -1.8, -0.2]; P = 0.008) and versus the no TENS group (group mean difference -1.8 [95% confidence interval -2.6, -1.0]; P < 0.0001). A reduction in movement-evoked fatigue was also reported in the active TENS group versus the placebo TENS group (group mean difference -1.4 [95% confidence interval -2.4, -0.4]; P = 0.001) and versus the no TENS group (group mean difference -1.9 [95% confidence interval -2.9, -0.9]; P = <0.0001). A greater percentage of the patients in the active TENS group reported improvement on the global impression of change compared to the placebo TENS group (70% versus 31%; P < 0.0001) and the no TENS group (9%; P < 0.0001). There were no TENS-related serious adverse events, and <5% of participants experienced minor adverse events from TENS.
CONCLUSION


Among women who had FM and were on a stable medication regimen, 4 weeks of active TENS use compared to placebo TENS or no TENS resulted in a significant improvement in movement-evoked pain and other clinical outcomes. Further research is needed to examine effectiveness in a real-world setting to establish the clinical importance of these findings.",2020,"A greater percentage of the active-TENS group reported improvement on the global impression of change when compared to placebo-TENS (70% vs. 31%, p<0.0001) and no-TENS (9%, p<0.0001).","['women with FM', 'Women with Fibromyalgia', 'Participants']","['Transcutaneous electrical nerve stimulation (TENS', 'active-TENS', 'placebo-TENS or no-TENS', 'placebo-TENS (n=99) or no-TENS', 'TENS']","['movement-evoked pain and fatigue', 'movement-evoked pain', 'global impression of change', 'movement-evoked pain (primary outcome) and fatigue on an 11-point scale']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}]","[{'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0222045'}]",,0.528626,"A greater percentage of the active-TENS group reported improvement on the global impression of change when compared to placebo-TENS (70% vs. 31%, p<0.0001) and no-TENS (9%, p<0.0001).","[{'ForeName': 'Dana L', 'Initials': 'DL', 'LastName': 'Dailey', 'Affiliation': 'University of Iowa, Iowa City, and St. Ambrose University, Davenport, Iowa.'}, {'ForeName': 'Carol G T', 'Initials': 'CGT', 'LastName': 'Vance', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Rakel', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'M Bridget', 'Initials': 'MB', 'LastName': 'Zimmerman', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Embree', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'Ericka N', 'Initials': 'EN', 'LastName': 'Merriwether', 'Affiliation': 'New York University, New York, New York.'}, {'ForeName': 'Katharine M', 'Initials': 'KM', 'LastName': 'Geasland', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Chimenti', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'Jon M', 'Initials': 'JM', 'LastName': 'Williams', 'Affiliation': 'Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Golchha', 'Affiliation': 'Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Leslie J', 'Initials': 'LJ', 'LastName': 'Crofford', 'Affiliation': 'Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Sluka', 'Affiliation': 'University of Iowa, Iowa City.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41170']
261,32334074,Bilateral nucleus basalis of Meynert deep brain stimulation for dementia with Lewy bodies: A randomised clinical trial.,"BACKGROUND


Dementia with Lewy bodies (DLB) is the second most common form of dementia. Current symptomatic treatment with medications remains inadequate. Deep brain stimulation of the nucleus basalis of Meynert (NBM DBS) has been proposed as a potential new treatment option in dementias.
OBJECTIVE


To assess the safety and tolerability of low frequency (20 Hz) NBM DBS in DLB patients and explore its potential effects on both clinical symptoms and functional connectivity in underlying cognitive networks.
METHODS


We conducted an exploratory randomised, double-blind, crossover trial of NBM DBS in six DLB patients recruited from two UK neuroscience centres. Patients were aged between 50 and 80 years, had mild-moderate dementia symptoms and were living with a carer-informant. Patients underwent image guided stereotactic implantation of bilateral DBS electrodes with the deepest contacts positioned in the Ch4i subsector of NBM. Patients were subsequently assigned to receive either active or sham stimulation for six weeks, followed by a two week washout period, then the opposite condition for six weeks. Safety and tolerability of both the surgery and stimulation were systematically evaluated throughout. Exploratory outcomes included the difference in scores on standardised measurements of cognitive, psychiatric and motor symptoms between the active and sham stimulation conditions, as well as differences in functional connectivity in discrete cognitive networks on resting state fMRI.
RESULTS


Surgery and stimulation were well tolerated by all six patients (five male, mean age 71.33 years). One serious adverse event occurred: one patient developed antibiotic-associated colitis, prolonging his hospital stay by two weeks. No consistent improvements were observed in exploratory clinical outcome measures, but the severity of neuropsychiatric symptoms reduced with NBM DBS in 3/5 patients. Active stimulation was associated with functional connectivity changes in both the default mode network and the frontoparietal network.
CONCLUSION


Low frequency NBM DBS can be safely conducted in DLB patients. This should encourage further exploration of the possible effects of stimulation on neuropsychiatric symptoms and corresponding changes in functional connectivity in cognitive networks.
TRIAL REGISTRATION NUMBER


NCT02263937.",2020,"No consistent improvements were observed in exploratory clinical outcome measures, but the severity of neuropsychiatric symptoms reduced with NBM DBS in 3/5 patients.","['Dementia with Lewy bodies (DLB', 'Patients were aged between 50-80 years, had mild-moderate dementia symptoms and were living with a carer-informant', 'six DLB patients recruited from two UK neuroscience centres', 'DLB patients', 'six patients (five male, mean age 71.33 years']","['NBM DBS', 'Bilateral Nucleus Basalis of Meynert Deep Brain Stimulation', 'image guided stereotactic implantation of bilateral DBS electrodes', 'active or sham stimulation', 'Meynert (NBM DBS']","['severity of neuropsychiatric symptoms', 'tolerated', 'safety and tolerability', 'functional connectivity in discrete cognitive networks on resting state fMRI', 'functional connectivity changes', 'Safety and tolerability', 'standardised measurements of cognitive, psychiatric and motor symptoms', 'antibiotic-associated colitis, prolonging his hospital stay']","[{'cui': 'C0752347', 'cui_str': 'Diffuse Lewy body disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",6.0,0.353614,"No consistent improvements were observed in exploratory clinical outcome measures, but the severity of neuropsychiatric symptoms reduced with NBM DBS in 3/5 patients.","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gratwicke', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK. Electronic address: j.gratwicke@ucl.ac.uk.'}, {'ForeName': 'Ludvic', 'Initials': 'L', 'LastName': 'Zrinzo', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Kahan', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Una', 'Initials': 'U', 'LastName': 'Brechany', 'Affiliation': 'Biomedical Research Building, Newcastle University & Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'McNichol', 'Affiliation': 'Biomedical Research Building, Newcastle University & Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Mazda', 'Initials': 'M', 'LastName': 'Beigi', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Harith', 'Initials': 'H', 'LastName': 'Akram', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hyam', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Oswal', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Day', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mancini', 'Affiliation': 'Lynsholm Department of Neuroradiology, The National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thornton', 'Affiliation': 'Lynsholm Department of Neuroradiology, The National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Yousry', 'Affiliation': 'Lynsholm Department of Neuroradiology, The National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Sebastian J', 'Initials': 'SJ', 'LastName': 'Crutch', 'Affiliation': 'Dementia Research Centre, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'John-Paul', 'Initials': 'JP', 'LastName': 'Taylor', 'Affiliation': 'Newcastle University & Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'McKeith', 'Affiliation': 'Newcastle University & Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Rochester', 'Affiliation': 'Biomedical Research Building, Newcastle University & Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Schott', 'Affiliation': 'Dementia Research Centre, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Limousin', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burn', 'Affiliation': 'Biomedical Research Building, Newcastle University & Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Martin N', 'Initials': 'MN', 'LastName': 'Rossor', 'Affiliation': 'Dementia Research Centre, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Hariz', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Jahanshahi', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Foltynie', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK. Electronic address: t.foltynie@ucl.ac.uk.'}]",Brain stimulation,['10.1016/j.brs.2020.04.010']
262,32334141,Blood eosinophil count group shifts and kinetics in severe eosinophilic asthma.,"BACKGROUND


Blood eosinophil count (BEC) measurements are a noninvasive, relatively reliable surrogate marker for eosinophilic airway inflammation. Single measurements of peripheral BEC greater than or equal to 150 cells/μL predict the response to anti-eosinophil therapies for patients with characteristics of severe eosinophilic asthma.
OBJECTIVE


To describe how BECs shift over time for patients with severe, uncontrolled asthma receiving placebo in 2 large, randomized, placebo-controlled clinical trials of benralizumab (SIROCCO and CALIMA).
METHODS


Our analysis included all adult patients who were randomized to placebo in the SIROCCO and CALIMA phase III benralizumab studies. Patients were categorized into baseline BEC groups of less than 150 cells/μL, greater than or equal to 150 cells/μL but less than 300 cells/μL, and greater than or equal to 300 cells/μL. The timing of the initial shift from baseline to a different group was evaluated at weeks 4, 8, 24, and 40 and at the end of treatment. Baseline characteristics, including oral corticosteroid use, were described based on the presence or absence of a BEC group shift.
RESULTS


Of the 734 evaluable patients, 65% (n = 474) shifted BEC groups during the study, and most patients (86% [n = 410]) shifted by week 24. Patients who started in the less than 150 cells/μL group tended to shift groups earlier, with 59% shifting by week 4 compared with 38% to 55% for other groups in the same time frame. Patients who shifted BEC groups vs those who did not tend to have lower BECs, more oral corticosteroid use, and less incidence of nasal polyps or past polypectomy.
CONCLUSION


A single BEC measurement, particularly when low, may be inadequate to help establish a phenotype of severe eosinophilic asthma.
TRIAL REGISTRATION


ClinicalTrials.gov Identifiers NCT01928771 (SIROCCO trial) and NCT01914757 (CALIMA trial).",2020,"Patients who shifted blood eosinophil count groups vs. those who did not tended to have lower blood eosinophil counts, more OCS use, and less incidence of nasal polyps/past polypectomy.
","['patients with severe, uncontrolled asthma receiving', 'patients with characteristics of severe eosinophilic asthma', '734 evaluable patients, 65% (n=474) shifted blood eosinophil count groups during the study, and the majority (86% [n=410]) shifted by Week 24']",['placebo'],"['incidence of nasal polyps/past polypectomy', 'blood eosinophil counts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0034068', 'cui_str': 'Eosinophilic asthma'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}]",734.0,0.0497634,"Patients who shifted blood eosinophil count groups vs. those who did not tended to have lower blood eosinophil counts, more OCS use, and less incidence of nasal polyps/past polypectomy.
","[{'ForeName': 'Njira L', 'Initials': 'NL', 'LastName': 'Lugogo', 'Affiliation': 'University of Michigan Medical Center, Ann Arbor, Michigan. Electronic address: nlugogo@med.umich.edu.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Kreindler', 'Affiliation': 'AstraZeneca, Wilmington, Delaware.'}, {'ForeName': 'Ubaldo J', 'Initials': 'UJ', 'LastName': 'Martin', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Cook', 'Affiliation': 'AstraZeneca, Wilmington, Delaware.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Hirsch', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Trudo', 'Affiliation': 'AstraZeneca, Wilmington, Delaware.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2020.04.011']
263,32330373,"Dietary supplementation with a novel l-carnitine multi-micronutrient in idiopathic male subfertility involving oligo-, astheno-, teratozoospermia: A randomized clinical study.","OBJECTIVE


To study the influence of a multi-component nutrient dietary supplement on sperm parameters and pregnancy rates in idiopathic male infertility (IMI) with oligo-, astheno-, and teratozoospermia.
DESIGN


A randomized, double-blind, placebo-controlled, prospective, parallel arms (1:1 allocation ratio), multi-center clinical trial.
SETTINGS


Eight urology/reproductive health clinical centers located in Ukraine.
PATIENTS


Eighty-three males aged 21-50 years with IMI and at least 1 of 3 abnormal values: total sperm concentration < 15 million/ml or/and spermatozoa progressive motility < 32% or/and forms with normal morphology < 4%.
INTERVENTION(S)


Patients were randomly allocated verum test dietary supplement (TDS) containing l-carnitine/acetyl-l-carnitine, l-arginine, glutathione, co-enzyme Q10, zinc, vitamin B 9  , vitamin B 12  , selenium, or placebo 1 time daily for 6 months.
MAIN OUTCOME(S)


The primary outcome measure was the percentage of normal spermiograms (concentration ≥ 15 million/ml and ≥ 32% of spermatozoa with progressive motility and ≥ 4% of normal forms) at month 0, 2, and 4. The percentage of pregnancies served the secondary outcome endpoint. Differences between the groups were assessed in z-test for proportions.
RESULTS


All males finished the study. At month 4, 29/42 (69.0%) males in the verum and 9/41 (22.0%) had normal spermiograms (P < .001). The percentage of spontaneous pregnancies in the verum group was greater than in the placebo group (10/42, 23.8% vs. 2/41, 4.9%, respectively, P = .017). There were no reportable supplement-associated adverse events.
CONCLUSION


Specific multi-nutrient combination l-carnitine/l-acetyl-carnitine, l-arginine, glutathione, co-enzyme-Q, zinc, folic acid, cyanocobalamin, and selenium can improve sperm quality in males with IMI and increase pregnancy rates.",2020,"Percent of spontaneous pregnancies in the verum group was greater than in the placebo group (10/42, 23.8% vs. 2/41, 4.9%, respectively, P = 0.017).","['Eight urology/reproductive health clinical centers located in Ukraine', 'males with IMI and increase pregnancy rates', 'idiopathic male subfertility involving oligo-, astheno-, teratozoospermia', 'Eighty-three males aged 21-50 years with IMI and at least 1 of 3 abnormal values: total sperm concentration < 15 million/ml or/and spermatozoa progressive motility < 32% or/and forms with normal morphology <4', 'idiopathic male infertility (IMI) with oligo-, astheno-, teratozoospermia']","['Specific multi-nutrient combination L-carnitine/ L-acetyl-carnitine, L-arginine, glutathione, co-enzyme-Q, zinc, folic acid, cyanocobalamin, and selenium', 'multicomponent nutrient dietary supplement', 'placebo', 'Dietary supplementation with a novel L-carnitine multi-micronutrient', 'verum test dietary supplement (TDS) containing L-carnitine/acetyl-L-carnitine, L-arginine, glutathione, co-enzyme-Q10, zinc, vitamin B 9  , vitamin B 12  , selenium or placebo']","['normal spermiograms', 'sperm parameters and pregnancy rates', 'spontaneous pregnancies', 'sperm quality', 'percentage of normal spermiograms (concentration ≥ 15 million/ml and ≥ 32% of spermatozoa with progressive motility and ≥ 4% of normal forms']","[{'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0041580', 'cui_str': 'Ukraine'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0021364', 'cui_str': 'Male infertility'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0848676', 'cui_str': 'Sub-Fertility, Male'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0028953', 'cui_str': 'Oligonucleotide'}, {'cui': 'C0403824', 'cui_str': 'Teratozoospermia'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0429845', 'cui_str': 'Sperm concentration measurement'}, {'cui': 'C1960956', 'cui_str': 'Million/milliliter'}, {'cui': 'C3854382', 'cui_str': 'Spermatozoa progressive motility'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0001040', 'cui_str': 'Acetylcarnitine'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0085798', 'cui_str': 'Glycogen Branching Enzyme'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1960956', 'cui_str': 'Million/milliliter'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",83.0,0.423096,"Percent of spontaneous pregnancies in the verum group was greater than in the placebo group (10/42, 23.8% vs. 2/41, 4.9%, respectively, P = 0.017).","[{'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Kopets', 'Affiliation': 'Medical Center ""Astar"", Lviv, Ukraine.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Kuibida', 'Affiliation': 'Precarpathian Center of Reproductive Health, Ivano-Frankivsk, Ukraine.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Chernyavska', 'Affiliation': 'Mykolaiv State Clinical Hospital, Mykolaiv, Ukraine.'}, {'ForeName': 'Vasyl', 'Initials': 'V', 'LastName': 'Cherepanyn', 'Affiliation': 'Lviv State Center for the Reproductive Health, Lviv, Ukraine.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Mazo', 'Affiliation': 'Private Urologic Practice, Mykolaiv, Ukraine.'}, {'ForeName': 'Vitaliy', 'Initials': 'V', 'LastName': 'Fedevych', 'Affiliation': 'Lviv State Hospital, Lviv, Ukraine.'}, {'ForeName': 'Sergiy', 'Initials': 'S', 'LastName': 'Gerasymov', 'Affiliation': 'MedianaStatistics, Lviv, Ukraine.'}]",Andrology,['10.1111/andr.12805']
264,31096264,Influence of Δ9-tetrahydrocannabinol on long-term neural correlates of threat extinction memory retention in humans.,"The neural mechanisms and durability of Δ9-tetrahydrocannabinol (THC) impact on threat processing in humans are not fully understood. Herein, we used functional MRI and psychophysiological tools to examine the influence of THC on the mechanisms of conditioned threat extinction learning, and the effects of THC on extinction memory retention when assessed 1 day and 1 week from learning. Healthy participants underwent threat conditioning on day 1. On day 2, participants were randomized to take one pill of THC or placebo (PBO) 2-h before threat extinction learning. Extinction memory retention was assessed 1 day and 1 week after extinction learning. We found that THC administration increased amygdala and ventromedial prefrontal cortex (vmPFC) activation during early extinction learning with no significant impact on skin conductance responses (SCR). When extinction memory retention was tested 24 h after learning, the THC group exhibited lower SCRs to the extinguished cue with no significant extinction-induced activations within the extinction network. When extinction memory retention was tested 1 week after learning, the THC group exhibited significantly decreased responses to the extinguished cues within the vmPFC and amygdala, but significantly increased functional coupling between the vmPFC, hippocampus, and dorsal anterior cingulate cortex during this extinction retention test. Our results are the first to report a long-term impact of one dose of THC on the functional activation of the threat extinction network and unveil a significant change in functional connectivity emerging after a week from engagement. We highlight the need for further investigating the long-term impact of THC on threat and anxiety circuitry.",2019,"When extinction memory retention was tested 24 h after learning, the THC group exhibited lower SCRs to the extinguished cue with no significant extinction-induced activations within the extinction network.","['humans', 'Healthy participants underwent threat conditioning on day 1']","['Δ9-tetrahydrocannabinol (THC', 'THC', 'Δ9-tetrahydrocannabinol', 'THC or placebo (PBO) 2-h before threat extinction learning']","['extinction memory retention', 'amygdala and ventromedial prefrontal cortex (vmPFC) activation', 'Extinction memory retention', 'functional coupling between the vmPFC, hippocampus, and dorsal anterior cingulate cortex', 'skin conductance responses (SCR']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}]","[{'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C3850122', 'cui_str': 'Ventral Medial Prefrontal Cortex'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C1123023', 'cui_str': 'Skin'}]",,0.0325937,"When extinction memory retention was tested 24 h after learning, the THC group exhibited lower SCRs to the extinguished cue with no significant extinction-induced activations within the extinction network.","[{'ForeName': 'Mira Z', 'Initials': 'MZ', 'LastName': 'Hammoud', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, USA. mhammoud@uic.edu.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Peters', 'Affiliation': 'Department of Pharmacy Practice and Department of Psychiatry & Behavioral Neuroscience, Wayne State University, Detroit, USA.'}, {'ForeName': 'Joshua R B', 'Initials': 'JRB', 'LastName': 'Hatfield', 'Affiliation': 'Department of Pharmacy Practice and Department of Psychiatry & Behavioral Neuroscience, Wayne State University, Detroit, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Gorka', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, USA.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, USA.'}, {'ForeName': 'Mohammed R', 'Initials': 'MR', 'LastName': 'Milad', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, USA.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Rabinak', 'Affiliation': 'Department of Pharmacy Practice and Department of Psychiatry & Behavioral Neuroscience, Wayne State University, Detroit, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0416-6']
265,31353857,Acoustic enhancement of sleep slow oscillations in mild cognitive impairment.,"OBJECTIVE


Slow-wave activity (SWA) during sleep is reduced in people with amnestic mild cognitive impairment (aMCI) and is related to sleep-dependent memory consolidation. Acoustic stimulation of slow oscillations has proven effective in enhancing SWA and memory in younger and older adults. In this study we aimed to determine whether acoustic stimulation during sleep boosts SWA and improves memory performance in people with aMCI.
METHODS


Nine adults with aMCI (72 ± 8.7 years) completed one night of acoustic stimulation (stim) and one night of sham stimulation (sham) in a blinded, randomized crossover study. Acoustic stimuli were delivered phase-locked to the upstate of the endogenous sleep slow-waves. Participants completed a declarative recall task with 44 word-pairs before and after sleep.
RESULTS


During intervals of acoustic stimulation, SWA increased by >10% over sham intervals (P < 0.01), but memory recall increased in only five of the nine patients. The increase in SWA with stimulation was associated with improved morning word recall (r = 0.78, P = 0.012).
INTERPRETATION


Acoustic stimulation delivered during slow-wave sleep over one night was effective for enhancing SWA in individuals with aMCI. Given established relationships between SWA and memory, a larger or more prolonged enhancement may be needed to consistently improve memory in aMCI.",2019,"The increase in SWA with stimulation was associated with improved morning word recall (r = 0.78, P = 0.012).
","['people with amnestic mild cognitive impairment (aMCI', 'Nine adults with aMCI (72\xa0±\xa08.7\xa0years) completed one', 'individuals with aMCI', 'younger and older adults', 'people with aMCI', 'mild cognitive impairment']","['acoustic stimulation', 'Acoustic stimulation of slow oscillations', 'Slow-wave activity (SWA', 'night of acoustic stimulation (stim) and one night of sham stimulation (sham']","['memory recall', 'declarative recall task', 'SWA', 'morning word recall', 'SWA with stimulation', 'memory performance']","[{'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0001164', 'cui_str': 'Stimulation, Auditory'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0679063', 'cui_str': 'Memory recall'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1285654', 'cui_str': 'Ability to remember'}]",9.0,0.264126,"The increase in SWA with stimulation was associated with improved morning word recall (r = 0.78, P = 0.012).
","[{'ForeName': 'Nelly A', 'Initials': 'NA', 'LastName': 'Papalambros', 'Affiliation': 'Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Weintraub', 'Affiliation': ""Mesulam Center for Cognitive Neurology and Alzheimer's Disease, Northwestern University Feinberg School of Medicine, Chicago, Illinois.""}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Grimaldi', 'Affiliation': 'Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Santostasi', 'Affiliation': 'Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Ken A', 'Initials': 'KA', 'LastName': 'Paller', 'Affiliation': 'Department of Psychology, Northwestern University, Evanston, Illinois.'}, {'ForeName': 'Phyllis C', 'Initials': 'PC', 'LastName': 'Zee', 'Affiliation': 'Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Roneil G', 'Initials': 'RG', 'LastName': 'Malkani', 'Affiliation': 'Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}]",Annals of clinical and translational neurology,['10.1002/acn3.796']
266,32334292,The impact of fascia iliaca compartment block on chronic postsurgical pain in patients undergoing hip fracture repair.,"STUDY OBJECTIVE


Chronic postsurgical pain (CPSP), i.e. pain persisting >3 months, may appear after any type of surgery. There is a paucity of literature addressing CPSP development after hip fracture repair and the impact of any analgesic intervention on the development of CPSP in patients after hip fracture surgery. This study is the first aiming to examine the impact of ultrasound-guided fascia iliaca compartment block (USG FICB) on the development of CPSP after hip fracture repair.
DESIGN


Prospective randomized study.
SETTING


Operating room.
PATIENTS


182 patients scheduled for hip fracture surgery.
INTERVENTIONS


Patients were randomized to receive a USG FICB (FICB group) or a sham saline injection (sham FICB group), twenty minutes before positioning for spinal anesthesia.
MEASUREMENTS


The hip - related characteristic pain intensity (CPI) at 3- months post-surgery was the primary outcome measure. Presence and severity of hip-related pain at 3- and 6-months post-surgery, numeric rating pain scale (NRS) scores at 6, 24, 36, 48 postoperative hours, total 24-hour tramadol PCA administration and timing of the first tramadol dose, were documented as well.
MAIN RESULTS


FICB group presented with lower CPI scores 3- months postoperatively (p < 0.01), as well as lower percentage of patients with high-grade CPSP, 3 and 6 months postoperatively (p < 0.001). FICB group also showed significantly lower NRS scores in all instances, lower total 24 - hour tramadol consumption and higher mean time to first tramadol dose (p < 0.05). The overall sample of 182 patients reported a considerably high incidence of hip -related CPSP (60% at 3 months, 45% at 6 months).
CONCLUSIONS


USG FICB in the perioperative setting may reduce the incidence, intensity and severity of CPSP at 3 and 6 months after hip fracture surgery, providing safe and effective postoperative analgesia.",2020,"FICB group also showed significantly lower NRS scores in all instances, lower total 24 - hour tramadol consumption and higher mean time to first tramadol dose (p < 0.05).","['patients undergoing hip fracture repair', 'patients after hip fracture surgery', '182 patients reported a considerably high incidence of hip -related', '182 patients scheduled for hip fracture surgery']","['fascia iliaca compartment block', 'ultrasound-guided fascia iliaca compartment block (USG FICB', 'USG FICB (FICB group) or a sham saline injection', 'FICB']","['CPI scores', 'NRS scores', 'CPSP', 'hip - related characteristic pain intensity (CPI', 'numeric rating pain scale (NRS) scores', 'incidence, intensity and severity of CPSP', 'chronic postsurgical pain', 'Presence and severity of hip-related pain', 'total 24-hour tramadol PCA administration and timing of the first tramadol dose']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C0225261', 'cui_str': 'Iliac fascia structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0246008', 'cui_str': 'CPI(1)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0030131', 'cui_str': 'p-Chloramphetamine'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",182.0,0.129944,"FICB group also showed significantly lower NRS scores in all instances, lower total 24 - hour tramadol consumption and higher mean time to first tramadol dose (p < 0.05).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Diakomi', 'Affiliation': 'Department of Anesthesiology, Asklepieion Hospital of Voula, Athens, Greece.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Papaioannou', 'Affiliation': 'Department of Anesthesiology, Asklepieion Hospital of Voula, Athens, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Georgoudis', 'Affiliation': 'Physiotherapy Department, University of West Attica, Athens, Greece.'}, {'ForeName': 'Erifili', 'Initials': 'E', 'LastName': 'Argyra', 'Affiliation': 'Department of Anesthesiology, Aretaieion University Hospital, Athens, Greece.'}, {'ForeName': 'Argyro', 'Initials': 'A', 'LastName': 'Mela', 'Affiliation': 'Department of Anesthesiology, Asklepieion Hospital of Voula, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Siafaka', 'Affiliation': 'Department of Anesthesiology, Aretaieion University Hospital, Athens, Greece.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Makris', 'Affiliation': 'Department of Anesthesiology, Asklepieion Hospital of Voula, Athens, Greece. Electronic address: makrisalexandros@hotmail.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109801']
267,32062566,Alleviation of ADHD symptoms by non-invasive right prefrontal stimulation is correlated with EEG activity.,"Attention deficit hyperactivity disorder (ADHD) is a prevalent disorder with effective pharmacological treatment that benefits most patients. However, about one-third fail to benefit while others search non-pharmacological alternatives, and for those options are scarce. One alternative treatment option is to alter abnormal right prefrontal cortex (rPFC) activity, given that rPFC abnormality has been repeatedly implicated in ADHD neurophathology. Here, we evaluated whether targeting the rPFC with multiple sessions of repetitive transcranial magnetic stimulation (rTMS), which can modulate neuronal excitability, activity, and plasticity in a non-invasive manner, will affect clinical symptoms in adults suffering from ADHD. Concomitantly, we used EEG to characterize electrophysiological alterations induced by treatment and to search for correlation between baseline neuronal activity and clinical response. Forty-three drug free adults with ADHD were randomized to receive either Real, Active Control, or Sham treatment (13 females, age ranging 21-46; n = 15, 14, 14, respectively), and underwent three weeks of daily high-frequency (18 Hz) stimulation sessions. We found that Real treatment was safe and resulted in significant improvement of symptoms (η 2 p  = 0.34; Cohen's d (against Sham)  = 0.96; Cohen's d (against AC)  = 0.68; p = 0.00085). Furthermore, based on EEG recorded within the first treatment session we established a novel biomarker, composed of the Alpha and Low-gamma power, which highly correlated the magnitude of the clinical outcome (r = 0.92, p = 0.0001). Taken together, the results of this pilot study indicate safety and effectiveness of rTMS directed to the rPFC for treatment of adult ADHD patients. The biomarker is suggested to reflect the responsiveness of the cortex to this rTMS intervention. Following validation of the results in larger samples, this study may represent a step towards a non-pharmacological treatment for adults with ADHD using EEG-based selection of optimal candidates for treatment.",2020,We found that Real treatment was safe and resulted in significant improvement of symptoms (η 2 p  = 0.34; Cohen's d (against Sham)  = 0.96; Cohen's d (against AC)  = 0.68; p = 0.00085).,"['Forty-three drug free adults with ADHD', 'adults suffering from ADHD', 'adult ADHD patients']","['Real, Active Control, or Sham treatment', 'repetitive transcranial magnetic stimulation (rTMS', 'rTMS']",['symptoms'],"[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0294365,We found that Real treatment was safe and resulted in significant improvement of symptoms (η 2 p  = 0.34; Cohen's d (against Sham)  = 0.96; Cohen's d (against AC)  = 0.68; p = 0.00085).,"[{'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Alyagon', 'Affiliation': 'Department of Life Sciences and the Zlotowski Centre for Neuroscience,\xa0Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Hamutal', 'Initials': 'H', 'LastName': 'Shahar', 'Affiliation': 'Department of Life Sciences and the Zlotowski Centre for Neuroscience,\xa0Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Aviad', 'Initials': 'A', 'LastName': 'Hadar', 'Affiliation': 'Department of Life Sciences and the Zlotowski Centre for Neuroscience,\xa0Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Barnea-Ygael', 'Affiliation': 'Department of Life Sciences and the Zlotowski Centre for Neuroscience,\xa0Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Lazarovits', 'Affiliation': 'Department of Life Sciences and the Zlotowski Centre for Neuroscience,\xa0Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Hadar', 'Initials': 'H', 'LastName': 'Shalev', 'Affiliation': 'Psychiatry Department, Soroka Medical Center, Beer-Sheva, Israel.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Zangen', 'Affiliation': 'Department of Life Sciences and the Zlotowski Centre for Neuroscience,\xa0Ben-Gurion University of the Negev, Beer-Sheva, Israel. Electronic address: azangen@bgu.ac.il.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102206']
268,32179059,Oxytocin increases the social salience of the outgroup in potential threat contexts.,"A growing body of literature suggests that OT administration may affect not only prosocial outcomes, but also regulate adversarial responses in the context of intergroup relations. However, recent reports have challenged the view of a fixed role of OT in enhancing ingroup favoritism and outgroup derogation. Studying the potential effects of OT in modulating threat perception in a context characterized by racial miscegenation (Brazil) may thus afford additional clarification on the matter. In a double-blind, placebo-controlled study, White Brazilian participants completed a first-person shooter task to assess their responses towards potential threat from racial ingroup (White) or outgroup (Black) members. OT administration enhanced the social salience of the outgroup, by both increasing the rate at which participants refrained from shooting unarmed Black targets to levels similar to White targets, and by further increasing the rate of correct decisions to shoot armed Black targets (versus White armed targets). In summary, our results indicate that a single dose of OT may promote accurate behavioral responses to potential threat from members of a racial outgroup, thus offering support to the social salience hypothesis.",2020,"OT administration enhanced the social salience of the outgroup, by both increasing the rate at which participants refrained from shooting unarmed Black targets to levels similar to White targets, and by further increasing the rate of correct decisions to shoot armed Black targets (versus White armed targets).",['White Brazilian participants completed a firstperson shooter task to assess their responses towards potential threat from racial ingroup (White) or outgroup (Black) members'],"['OT', 'Oxytocin', 'placebo']",['social salience'],"[{'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3875150', 'cui_str': 'Towards'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.040038,"OT administration enhanced the social salience of the outgroup, by both increasing the rate at which participants refrained from shooting unarmed Black targets to levels similar to White targets, and by further increasing the rate of correct decisions to shoot armed Black targets (versus White armed targets).","[{'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Egito', 'Affiliation': 'Social and Cognitive Neuroscience Laboratory and Developmental Disorders Graduate Program, Center for Biological and Health Sciences, Mackenzie Presbyterian University, São Paulo, Brazil.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nevat', 'Affiliation': 'The Integrated Brain and Behavior Research Center (IBBR) and Department of Psychology, University of Haifa, Haifa, 3498838, Israel.'}, {'ForeName': 'Simone G', 'Initials': 'SG', 'LastName': 'Shamay-Tsoory', 'Affiliation': 'The Integrated Brain and Behavior Research Center (IBBR) and Department of Psychology, University of Haifa, Haifa, 3498838, Israel.'}, {'ForeName': 'Ana Alexandra C', 'Initials': 'AAC', 'LastName': 'Osório', 'Affiliation': 'Social and Cognitive Neuroscience Laboratory and Developmental Disorders Graduate Program, Center for Biological and Health Sciences, Mackenzie Presbyterian University, São Paulo, Brazil. Electronic address: ana.osorio@mackenzie.br.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104733']
269,31525334,Acupuncture vs Noninsertive Sham Acupuncture in Aging Patients with Degenerative Lumbar Spinal Stenosis: A Randomized Controlled Trial.,"BACKGROUND


Acupuncture is commonly used to treat degenerative lumbar spinal stenosis in Asian countries. However, rigorous data regarding the efficacy and safety of acupuncture for aging patients are currently lacking.
METHODS


Eighty patients older than 50 years were assigned randomly to the acupuncture group or the noninsertive sham acupuncture for 24 treatments over an 8-week period. Measurements were obtained at baseline and 4 and 8 weeks of treatment; and 3 and 6 months after completion of treatment. The primary outcome was a change in the 24-point Roland Morris Disability Questionnaire scores at the end of treatment. The secondary outcomes included disability, pain intensity, symptoms, and dysfunction.
RESULTS


At the end of treatment, mean changes in the Roland Morris Disability Questionnaire were -4.1 (95% CI, -4.9 to -3.3) in the acupuncture group and -1.5 (95% CI, -2.3 to -0.7) in the sham group, with a statistically significant between-group difference: -2.6 (95% CI, -3.7 to -1.4). Acupuncture was superior to sham acupuncture in reducing pain intensity (between-group difference: -2.9 [95% CI, -3.8 to -2.0] in leg and buttock pain, vs -2.3 [95% CI, -3.0 to -1.5] in back pain), symptoms and dysfunction (between-group difference: -0.9 [95% CI, -1.2 to -0.6] in symptom subscale, and -0.8 [95% CI, -1.1 to -0.5] in dysfunction subscale).
CONCLUSIONS


Acupuncture provides immediate functional recovery and pain relief for degenerative lumbar spinal stenosis. However, current evidence is insufficient to support the suggestion that acupuncture could offer clinical benefits as compared with noninsertive sham acupuncture for degenerative lumbar spinal stenosis.",2020,"Acupuncture was superior to sham acupuncture in reducing pain intensity (between-group difference: -2.9 [95% CI, -3.8 to -2.0] in leg and buttock pain vs. -2.3","['Ageing Patients with Degenerative Lumbar Spinal Stenosis', 'degenerative lumbar spinal stenosis', 'degenerative lumbar spinal stenosis in Asian countries', 'Eighty patients older than 50years']","['Acupuncture vs Noninsertive Sham Acupuncture', 'Acupuncture', 'acupuncture', 'noninsertive sham acupuncture']","['mean changes of RMDQ', 'back pain), symptoms and dysfunction', 'change in the 24-point Roland Morris Disability Questionnaire (RMDQ) scores', 'efficacy and safety', 'symptom subscale', 'pain intensity', 'disability, pain intensity, symptoms and dysfunction', 'leg and buttock pain', 'dysfunction subscale']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0410636', 'cui_str': 'Degenerative lumbar spinal stenosis (disorder)'}, {'cui': 'C0454705', 'cui_str': 'Asian country (geographic location)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0231710', 'cui_str': 'Pygalgia'}]",80.0,0.44852,"Acupuncture was superior to sham acupuncture in reducing pain intensity (between-group difference: -2.9 [95% CI, -3.8 to -2.0] in leg and buttock pain vs. -2.3","[{'ForeName': 'Zongshi', 'Initials': 'Z', 'LastName': 'Qin', 'Affiliation': ""Department of Acupuncture and Neurology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China; School of Chinese Medicine, LKS Faculty of Medicine, The University of Hong Kong, China.""}, {'ForeName': 'Yulong', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Department of Acupuncture and Neurology, Beijing Fengtai Hospital of Integrated Traditional and Western Medicine, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, China; Department of Population Medicine, College of Medicine, Qatar University, Doha, Qatar.'}, {'ForeName': 'Joey S W', 'Initials': 'JSW', 'LastName': 'Kwong', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, Faculty of Medicine, The Chinese University of Hong Kong, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'Department of Acupuncture and Neurology, Beijing Fengtai Hospital of Integrated Traditional and Western Medicine, China.'}, {'ForeName': 'Aimin', 'Initials': 'A', 'LastName': 'Wu', 'Affiliation': ""Department of Spine Surgery, Zhejiang Spine Surgery Centre, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Zhejiang, China.""}, {'ForeName': 'Jiani', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Department of Acupuncture and Neurology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Zhishun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Acupuncture and Neurology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China. Electronic address: liuzhishun@aliyun.com.""}]",The American journal of medicine,['10.1016/j.amjmed.2019.08.038']
270,32327440,Development and validation of an early pregnancy risk score for the prediction of gestational diabetes mellitus in Chinese pregnant women.,"OBJECTIVE


To develop and validate a set of risk scores for the prediction of gestational diabetes mellitus (GDM) before the 15th gestational week using an established population-based prospective cohort.
METHODS


From October 2010 to August 2012, 19 331 eligible pregnant women were registered in the three-tiered antenatal care network in Tianjin, China, to receive their antenatal care and a two-step GDM screening. The whole dataset was randomly divided into a training dataset (for development of the risk score) and a test dataset (for validation of performance of the risk score). Logistic regression was performed to obtain coefficients of selected predictors for GDM in the training dataset. Calibration was estimated using Hosmer-Lemeshow test, while discrimination was checked using area under the receiver operating characteristic curve (AUC) in the test dataset.
RESULTS


In the training dataset (total=12 887, GDM=979 or 7.6%), two risk scores were developed, one only including predictors collected at the first antenatal care visit for early prediction of GDM, like maternal age, body mass index, height, family history of diabetes, systolic blood pressure, and alanine aminotransferase; and the other also including predictors collected during pregnancy, that is, at the time of GDM screening, like physical activity, sitting time at home, passive smoking, and weight gain, for maximum performance. In the test dataset (total=6444, GDM=506 or 7.9%), the calibrations of both risk scores were acceptable (both p for Hosmer-Lemeshow test >0.25). The AUCs of the first and second risk scores were 0.710 (95% CI: 0.680 to 0.741) and 0.712 (95% CI: 0.682 to 0.743), respectively (p for difference: 0.9273).
CONCLUSION


Both developed risk scores had adequate performance for the prediction of GDM in Chinese pregnant women in Tianjin, China. Further validations are needed to evaluate their performance in other populations and using different methods to identify GDM cases.",2020,"The AUCs of the first and second risk scores were 0.710 (95% CI: 0.680 to 0.741) and 0.712 (95% CI: 0.682 to 0.743), respectively (p for difference: 0.9273).
","['gestational diabetes mellitus (GDM) before the 15th gestational week using an established population-based prospective cohort', 'From October 2010 to August 2012, 19 331 eligible pregnant women were registered in the three-tiered antenatal care network in Tianjin, China, to receive their antenatal care and a two-step GDM screening', 'Chinese pregnant women in Tianjin, China', 'Chinese pregnant women']",[],"['gestational diabetes mellitus', 'time of GDM screening, like physical activity, sitting time at home, passive smoking, and weight gain, for maximum performance', 'AUCs of the first and second risk scores', 'antenatal care visit for early prediction of GDM, like maternal age, body mass index, height, family history of diabetes, systolic blood pressure, and alanine aminotransferase']","[{'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]",[],"[{'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0037370', 'cui_str': 'Passive smoking'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1313937', 'cui_str': 'Family history of diabetes mellitus'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}]",19331.0,0.0383423,"The AUCs of the first and second risk scores were 0.710 (95% CI: 0.680 to 0.741) and 0.712 (95% CI: 0.682 to 0.743), respectively (p for difference: 0.9273).
","[{'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Junhong', 'Initials': 'J', 'LastName': 'Leng', 'Affiliation': ""Department of Child Health, Tianjin Women and Children's Health Center, Tianjin, China.""}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Child Health, Tianjin Women and Children's Health Center, Tianjin, China.""}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Project Office, Tianjin Women and Children's Health Center, Tianjin, China.""}, {'ForeName': 'Weiqin', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Project Office, Tianjin Women and Children's Health Center, Tianjin, China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Child Health, Tianjin Women and Children's Health Center, Tianjin, China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Hu', 'Affiliation': 'Chronic Disease Epidemiology Laboratory, Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Juliana C N', 'Initials': 'JCN', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine and Therapeutics, Prince of Wales Hospital-International Diabetes Federation Centre of Education, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Population Cancer Research Program and Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China zhuhong@tmu.edu.cn.'}, {'ForeName': 'Xilin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-000909']
271,32145674,"A double-blind, randomized, sham-controlled study of cranial electrotherapy stimulation as an add-on treatment for tic disorders in children and adolescents.","AIM


The aim of this study was to determine the efficacy and safety of cranial electrotherapy stimulation (CES) as an add-on treatment for TD.
METHODS


A randomized, double-blind, sham-controlled trial was conducted at an outpatient, single-center academic setting. A total of 62 patients aged 6-17 years with TD and lack of clinical response to 4 weeks' pharmacotherapy were enrolled. Patients were divided randomly into 2 groups and given 4 weeks' treatment, including 30 min sessions of active CES (500 μA-2 mA) or sham CES (lower than 100 μA) per day for 40 d on weekdays. Change in Yale Global Tic Severity Scale (YGTSS), Clinical Global Impression-severity of illness-severity (CGI-S) and Hamilton Anxiety Scale-14 items (HAMA-14) were performed at baseline, week 2, week 4. Adverse events (AEs) were also evaluated.
RESULTS


53 patients (34 males and 9 females) completed the trial, including 29 in the active CES group and 24 in the sham CES group. Both groups showed clinical improvement in tic severities compared to baseline respectively at week 4. Participants receiving active CES showed a reduction of 31.66 % in YGTSS score, compared with 23.96 % in participants in sham CES group, resulting in no significant difference between the two groups (t = 1.54, p = 0.13).
CONCLUSION


Four-week's treatment of CES for children and adolescents with TD is effective and safe, but the improvement for tic severity may be related to placebo effect.",2020,"Participants receiving active CES showed a reduction of 31.66 % in YGTSS score, compared with 23.96 % in participants in sham CES group, resulting in no significant difference between the two groups (t = 1.54, p = 0.13).
","[""62 patients aged 6-17 years with TD and lack of clinical response to 4 weeks' pharmacotherapy were enrolled"", 'tic disorders in children and adolescents', '53 patients (34 males and 9 females) completed the trial, including 29 in the active CES group and 24 in the sham CES group']","['cranial electrotherapy stimulation', 'active CES', 'cranial electrotherapy stimulation (CES', 'active CES (500\u2009μA-2\u2009mA) or sham CES']","['clinical improvement in tic severities', 'Yale Global Tic Severity Scale (YGTSS), Clinical Global Impression-severity of illness-severity (CGI-S) and Hamilton Anxiety', 'efficacy and safety', 'Adverse events (AEs', 'YGTSS score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder (disorder)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C3163632', 'cui_str': 'Cranial'}, {'cui': 'C0013787', 'cui_str': 'Electrical Stimulation Therapy'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0278076', 'cui_str': 'Habit Chorea'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C4720888', 'cui_str': 'Yale global tic severity scale (assessment scale)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",62.0,0.38816,"Participants receiving active CES showed a reduction of 31.66 % in YGTSS score, compared with 23.96 % in participants in sham CES group, resulting in no significant difference between the two groups (t = 1.54, p = 0.13).
","[{'ForeName': 'Wen-Jun', 'Initials': 'WJ', 'LastName': 'Wu', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: wenjun104@126.com.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: fgx995@163.com.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Cai', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: caimin@fmmu.edu.cn.""}, {'ForeName': 'Yi-Huan', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: 182368179@qq.com.""}, {'ForeName': 'Cui-Hong', 'Initials': 'CH', 'LastName': 'Zhou', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: zch4610@126.com.""}, {'ForeName': 'Hua-Ning', 'Initials': 'HN', 'LastName': 'Wang', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: xskzhu@fmmu.edu.cn.""}, {'ForeName': 'Long-Biao', 'Initials': 'LB', 'LastName': 'Cui', 'Affiliation': ""Department of Clinical Psychology, School of Medical Psychology, Fourth Military Medical University, 169 # West Changle Road, Xi'an, 710032, China. Electronic address: lbcui@fmmu.edu.cn.""}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.101992']
272,31989459,"Prevention of Pain During Screening for Retinopathy of Prematurity: A Randomized Control Trial Comparing Breast Milk, 10% Dextrose and Sterile Water.","OBJECTIVES


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


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


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


Expressed breast milk, 10% dextrose or sterile water administered orally before ROP screening in preterm neonates have similar analgesic effects and do not significantly alleviate pain during the procedure.",2020,The mean PIPP scores were comparable (p = 0.18) in the three groups (11.8 ± 2.8 vs. 9.8 ± 3.3 vs. 10.2 ± 2.9).,"['Forty five preterm neonates undergoing ROP screening were included', 'Retinopathy of Prematurity', 'Eligible babies', 'Level 3 neonatal intensive care unit']","['expressed breast milk (n\u2009=\u200914), 10% dextrose solution (n\u2009=\u200914) or sterile water', '10% dextrose, breast milk and sterile water on pain prevention', 'Dextrose and Sterile Water']","['mean PIPP scores', 'analgesic effects', 'PIPP score', 'alleviate pain', 'Retinopathy of prematurity (ROP']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0456949', 'cui_str': 'Level 3 (qualifier value)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}]","[{'cui': 'C0452739', 'cui_str': 'Expressed breast milk (substance)'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0359299', 'cui_str': 'sterile water'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}]",45.0,0.608043,The mean PIPP scores were comparable (p = 0.18) in the three groups (11.8 ± 2.8 vs. 9.8 ± 3.3 vs. 10.2 ± 2.9).,"[{'ForeName': 'Ramya', 'Initials': 'R', 'LastName': 'Nayak', 'Affiliation': 'Department of Pediatrics, Melaka Manipal Medical College, Manipal Academy of Higher Education, Manipal, India. dr.ramyanayak@gmail.com.'}, {'ForeName': 'Kalale Nikhil', 'Initials': 'KN', 'LastName': 'Nagaraj', 'Affiliation': 'Department of Pediatrics, Motherhood Hospital, Sahakarnagar, Bangalore, India.'}, {'ForeName': 'Girish', 'Initials': 'G', 'LastName': 'Gururaj', 'Affiliation': 'Department of Neonatology, Apollo BGS Hospitals, Mysore, India.'}]",Indian journal of pediatrics,['10.1007/s12098-020-03182-6']
273,31012044,Three-Dimensional Visualization Technology Used in Pancreatic Surgery: a Valuable Tool for Surgical Trainees.,"PURPOSE


Three-dimensional (3D) visualization technology has been increasingly applied in patient-specific surgeries, but its value in residency training has not been determined. This study aimed to explore the value of 3D visualized pancreatic model in tumor evaluation and surgery planning for surgical trainees.
METHODS


Eighty-eight surgical residents were randomized into two groups (computed tomography (CT) group and 3D group). Both groups began with a training on evaluating the resectability of pancreatic tumor, which was based on the NCCN clinical practice guidelines and practiced on a sample case. Then, they respectively learned the sample case either on 3D reconstruction visualization tables or CT images. Finally, both groups completed a same test consisting of two pancreatic cases with CT images as well as questionnaires.
RESULTS


No differences were found in scores of the anatomy and diagnosis part, while mean scores for questions, associated with tumor staging and surgery planning, were consistently and significantly higher in the 3D group. In addition, participants in 3D group agreed that 3D technology was more beneficial in understanding and making pancreatic surgery planning.
CONCLUSION


The 3D visualization table may be a potential supplemental learning tool in building anatomy-image-surgery knowledge system and thus making surgery planning for surgical trainees.",2020,"No differences were found in scores of the anatomy and diagnosis part, while mean scores for questions, associated with tumor staging and surgery planning, were consistently and significantly higher in the 3D group.",['Eighty-eight surgical residents'],['computed tomography (CT'],"['scores of the anatomy and diagnosis part, while mean scores for questions, associated with tumor staging and surgery planning']","[{'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}]",88.0,0.0121908,"No differences were found in scores of the anatomy and diagnosis part, while mean scores for questions, associated with tumor staging and surgery planning, were consistently and significantly higher in the 3D group.","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': 'Department of General Surgery, Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.'}, {'ForeName': 'Junyi', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Eight-year Program of Clinical Medicine, PUMCH, CAMS & PUMC, Beijing, 100730, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Eight-year Program of Clinical Medicine, PUMCH, CAMS & PUMC, Beijing, 100730, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Education, PUMCH, CAMS & PUMC, Beijing, 100730, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Head and Neck Surgery, PUMCH, CAMS & PUMC, Beijing, 100730, China.'}, {'ForeName': 'Guole', 'Initials': 'G', 'LastName': 'Lin', 'Affiliation': 'Department of General Surgery, Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.'}, {'ForeName': 'Hanzhong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Urology Surgery, PUMCH, CAMS & PUMC, Beijing, 100730, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'National Virtual Simulation Laboratory Education Center of Medical Sciences, PUMCH, CAMS & PUMC, Beijing, 100730, China.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Liao', 'Affiliation': 'Department of General Surgery, Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China. lqpumc@126.com.'}, {'ForeName': 'Yupei', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of General Surgery, Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China. zhao8028@263.net.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-019-04214-z']
274,31042696,Effects of MDMA on attention to positive social cues and pleasantness of affective touch.,"The psychostimulant drug ±3,4-methylenedioxymethamphetamine (MDMA) reportedly produces distinctive feelings of empathy and closeness with others. MDMA increases social behavior in animal models and has shown promise in psychiatric disorders, such as autism spectrum disorder (ASD) and post-traumatic stress disorder (PTSD). How it produces these prosocial effects is not known. This behavioral and psychophysiological study examined the effects of MDMA, compared with the prototypical stimulant methamphetamine (MA), on two measures of social behavior in healthy young adults: (i) responses to socially relevant, ""affective"" touch, and (ii) visual attention to emotional faces. Men and women (N = 36) attended four sessions in which they received MDMA (0.75 or 1.5 mg/kg), MA (20 mg), or a placebo in randomized order under double-blind conditions. Responses to experienced and observed affective touch (i.e., being touched or watching others being touched) were assessed using facial electromyography (EMG), a proxy of affective state. Responses to emotional faces were assessed using electrooculography (EOG) in a measure of attentional bias. Subjective ratings were also included. We hypothesized that MDMA, but not MA, would enhance the ratings of pleasantness and psychophysiological responses to affective touch and increase attentional bias toward positive facial expressions. Consistent with this, we found that MDMA, but not MA, selectively enhanced ratings of pleasantness of experienced affective touch. Neither drug altered the ratings of pleasantness of observed touch. On the EOG measure of attentional bias, MDMA, but not MA, increased attention toward happy faces. These results provide new evidence that MDMA can enhance the experience of positive social interactions; in this case, pleasantness of physical touch and attentional bias toward positive facial expressions. The findings are consistent with evidence that the prosocial effects are unique to MDMA relative to another stimulant. Understanding the behavioral and neurobiological processes underlying the distinctive social effects of MDMA is a key step to developing the drug for psychiatric disorders.",2019,"On the EOG measure of attentional bias, MDMA, but not MA, increased attention toward happy faces.","['Men and women (N\u2009=\u200936) attended four sessions in which they received', 'healthy young adults']","['placebo', 'psychostimulant drug ±3,4-methylenedioxymethamphetamine (MDMA', 'MDMA', 'electrooculography (EOG', 'MA', 'prototypical stimulant methamphetamine (MA']","['ratings of pleasantness and psychophysiological responses to affective touch and increase attentional bias toward positive facial expressions', 'positive social cues and pleasantness of affective touch', 'Subjective ratings', 'ratings of pleasantness of observed touch', 'attention toward happy faces']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0304403', 'cui_str': 'Psychostimulant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0013854', 'cui_str': 'EOG'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}]","[{'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0015457', 'cui_str': 'Facial Expression'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]",,0.0389876,"On the EOG measure of attentional bias, MDMA, but not MA, increased attention toward happy faces.","[{'ForeName': 'Anya K', 'Initials': 'AK', 'LastName': 'Bershad', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Mayo', 'Affiliation': 'Center for Social and Affective Neuroscience, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Kathryne', 'Initials': 'K', 'LastName': 'Van Hedger', 'Affiliation': 'Department of Clinical Neurological Sciences, University of Western Ontario, London, ON, UK.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'McGlone', 'Affiliation': 'School of Natural Sciences and Psychology, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Susannah C', 'Initials': 'SC', 'LastName': 'Walker', 'Affiliation': 'School of Natural Sciences and Psychology, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA. hdew@uchicago.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0402-z']
275,32327444,High or low glycemic index (GI) meals at dinner results in greater postprandial glycemia compared with breakfast: a randomized controlled trial.,"INTRODUCTION


While circadian control of glucose metabolism is well known, how glycemic index (GI) of carbohydrate-rich meals interacts with time of consumption (breakfast or dinner) to influence postprandial (PP) glucose homeostasis is less well established. The objective of the study was to assess markers of PP glucose homeostasis following high or low GI test meals (TM) consumed either at breakfast or at dinner and following consumption of the subsequent standardized meals (SSM).
RESEARCH DESIGN AND METHODS


Randomized crossover trial in 34 healthy, Chinese, elderly volunteers (mean±SEM age, 56.8±0.83 years), who completed 4 separate study sessions per-protocol, consisting of a high-GI breakfast, low-GI breakfast, high-GI dinner and low-GI dinner TM, followed by a SSM at the subsequent eating occasion. Blood samples were taken for 3 hours after each TM and SSM for glucose, insulin, glucagon, free fatty acids (FFA) and triglycerides (TG) measurements.
RESULTS


Consuming TM at dinner produced greater PP glycemia than breakfast both after TM and SSM (both p<0.0001), irrespective of GI. High-GI TM also produced greater PP glycemia than low-GI TM, both after TM and SSM (both p<0.01), irrespective of time of consumption. No interaction between GI and time were found on PP glycemia, indicating parallel, but independent effects. Combined total areas under the curve of TM+SSM for PP glucose (p<0.0001), PP TG (p<0.0001) and PP FFA (p<0.0001) were all greater when TM taken during dinner compared with breakfast.
CONCLUSIONS


Carbohydrate-rich meals consumed at dinner leads to significantly worse PP glucose homeostasis than when consumed at breakfast, on top of the independent GI effect of the meal. This may have implications to future type 2 diabetes risk. Moreover, future studies investigating GI/glycemic load (GL) and disease risk associations should factor in timing of GL consumption as an additional variable.
TRIAL REGISTRATION NUMBER


NCT02927600.",2020,"Combined total areas under the curve of TM+SSM for PP glucose (p<0.0001), PP TG (p<0.0001) and PP FFA (p<0.0001) were all greater when TM taken during dinner compared with breakfast.
","['34 healthy, Chinese, elderly volunteers (mean±SEM\u2009age, 56.8±0.83 years), who completed 4 separate study sessions per-protocol, consisting of a high-GI breakfast, low-GI breakfast, high-GI dinner and low-GI dinner TM, followed by a SSM at the subsequent eating occasion']","['high or low GI test meals (TM) consumed either at breakfast or at dinner and following consumption of the subsequent standardized meals (SSM', 'TM and SSM ', 'High-GI TM', 'High or low glycemic index (GI) meals']","['postprandial glycemia', 'PP glycemia', 'PP glucose homeostasis', 'glucose, insulin, glucagon, free fatty acids (FFA) and triglycerides (TG) measurements', 'curve of TM+SSM for PP glucose (p<0.0001), PP TG (p<0.0001) and PP FFA']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",34.0,0.216708,"Combined total areas under the curve of TM+SSM for PP glucose (p<0.0001), PP TG (p<0.0001) and PP FFA (p<0.0001) were all greater when TM taken during dinner compared with breakfast.
","[{'ForeName': 'Sumanto', 'Initials': 'S', 'LastName': 'Haldar', 'Affiliation': 'Clinical Nutrition Research Centre, Singapore Institute for Clinical Sciences, Singapore.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Egli', 'Affiliation': 'Nestle Institute of Health Sciences, Lausanne, Switzerland.'}, {'ForeName': 'Carlos Antonio', 'Initials': 'CA', 'LastName': 'De Castro', 'Affiliation': 'Nestle Research Asia, Nestle Institute of Health Sciences, Singapore.'}, {'ForeName': 'Shia Lyn', 'Initials': 'SL', 'LastName': 'Tay', 'Affiliation': 'Clinical Nutrition Research Centre, Singapore Institute for Clinical Sciences, Singapore.'}, {'ForeName': 'Melvin Xu Nian', 'Initials': 'MXN', 'LastName': 'Koh', 'Affiliation': 'Clinical Nutrition Research Centre, Singapore Institute for Clinical Sciences, Singapore.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Darimont', 'Affiliation': 'Nestle Institute of Health Sciences, Lausanne, Switzerland.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Mace', 'Affiliation': 'Nestle Institute of Health Sciences, Lausanne, Switzerland.'}, {'ForeName': 'Christiani Jeyakumar', 'Initials': 'CJ', 'LastName': 'Henry', 'Affiliation': 'Clinical Nutrition Research Centre, Singapore Institute for Clinical Sciences, Singapore jeya_henry@sics.a-star.edu.sg.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-001099']
276,32327474,Reducing medicine-induced deterioration and adverse reactions (ReMInDAR) trial: study protocol for a randomised controlled trial in residential aged-care facilities assessing frailty as the primary outcome.,"INTRODUCTION


Many medicines have adverse effects which are difficult to detect and frequently go unrecognised. Pharmacist monitoring of changes in signs and symptoms of these adverse effects, which we describe as medicine-induced deterioration, may reduce the risk of developing frailty. The aim of this trial is to determine the effectiveness of a 12-month pharmacist service compared with usual care in reducing medicine-induced deterioration, frailty and adverse reactions in older people living in aged-care facilities in Australia.
METHODS AND ANALYSIS


The reducing medicine-induced deterioration and adverse reactions trial is a multicentre, open-label randomised controlled trial. Participants will be recruited from 39 facilities in South Australia and Tasmania. Residents will be included if they are using four or more medicines at the time of recruitment, or taking more than one medicine with anticholinergic or sedative properties. The intervention group will receive a pharmacist assessment which occurs every 8 weeks. The pharmacists will liaise with the participants' general practitioners when medicine-induced deterioration is evident or adverse events are considered serious. The primary outcome is a reduction in medicine-induced deterioration from baseline to 6 and 12 months, as measured by change in frailty index. The secondary outcomes are changes in cognition scores, 24-hour movement behaviour, grip strength, weight, percentage robust, pre-frail and frail classification, rate of adverse medicine events, health-related quality of life and health resource use. The statistical analysis will use mixed-models adjusted for baseline to account for repeated outcome measures. A health economic evaluation will be conducted following trial completion using data collected during the trial.
ETHICS AND DISSEMINATION


Ethics approvals have been obtained from the Human Research Ethics Committee of University of South Australia (ID:0000036440) and University of Tasmania (ID:H0017022). A copy of the final report will be provided to the Australian Government Department of Health.
TRIAL REGISTRATION NUMBER


Australian and New Zealand Trials Registry ACTRN12618000766213.",2020,"The secondary outcomes are changes in cognition scores, 24-hour movement behaviour, grip strength, weight, percentage robust, pre-frail and frail classification, rate of adverse medicine events, health-related quality of life and health resource use.","['Participants will be recruited from 39 facilities in South Australia and Tasmania', 'Residents will be included if they are using four or more medicines at the time of recruitment, or taking more than one medicine with anticholinergic or sedative properties', 'residential aged-care facilities', 'older people living in aged-care facilities in Australia']",['pharmacist service compared with usual care'],"['frailty index', 'reduction in medicine-induced deterioration', 'changes in cognition scores, 24-hour movement behaviour, grip strength, weight, percentage robust, pre-frail and frail classification, rate of adverse medicine events, health-related quality of life and health resource use']","[{'cui': 'C0037715', 'cui_str': 'South Australia'}, {'cui': 'C0039335', 'cui_str': 'Tasmania'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.319413,"The secondary outcomes are changes in cognition scores, 24-hour movement behaviour, grip strength, weight, percentage robust, pre-frail and frail classification, rate of adverse medicine events, health-related quality of life and health resource use.","[{'ForeName': 'Renly', 'Initials': 'R', 'LastName': 'Lim', 'Affiliation': 'Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical & Health Sciences, University of South Australia, Adelaide, South Australia, Australia renly.lim@unisa.edu.au.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Bereznicki', 'Affiliation': 'School of Medicine, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Corlis', 'Affiliation': 'Helping Hand Aged Care, North Adelaide, South Australia, Australia.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Kalisch Ellett', 'Affiliation': 'Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical & Health Sciences, University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ai Choo', 'Initials': 'AC', 'LastName': 'Kang', 'Affiliation': 'Southern Cross Care (SA&NT), Adelaide, South Australia, Australia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Merlin', 'Affiliation': 'Discipline of Public Health, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Gaynor', 'Initials': 'G', 'LastName': 'Parfitt', 'Affiliation': 'UniSA Allied Health and Human Performance, University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Pratt', 'Affiliation': 'Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical & Health Sciences, University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Rowett', 'Affiliation': 'UniSA Clinical & Health Sciences, University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Torode', 'Affiliation': 'Southern Cross Care (SA&NT), Adelaide, South Australia, Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Whitehouse', 'Affiliation': 'Pharmacy Improvement Centre Ltd, Welland, South Australia, Australia.'}, {'ForeName': 'Andre Q', 'Initials': 'AQ', 'LastName': 'Andrade', 'Affiliation': 'Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical & Health Sciences, University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Bilton', 'Affiliation': 'Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical & Health Sciences, University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Cousins', 'Affiliation': 'School of Medicine, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Kelly', 'Affiliation': 'Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical & Health Sciences, University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Schubert', 'Affiliation': 'Discipline of Public Health, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Elizabeth Ellen', 'Initials': 'EE', 'LastName': 'Roughead', 'Affiliation': 'Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical & Health Sciences, University of South Australia, Adelaide, South Australia, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-032851']
277,30885692,Adeno-associated virus vectored immunoprophylaxis to prevent HIV in healthy adults: a phase 1 randomised controlled trial.,"BACKGROUND


A preventive vaccine for HIV is a crucial public health need; adeno-associated virus (AAV)-mediated antibody gene delivery could be an alternative to immunisation to induce sustained expression of neutralising antibodies to prevent HIV. We assessed safety and tolerability of rAAV1-PG9DP, a recombinant AAV1 vector encoding the gene for PG9, a broadly neutralising antibody against HIV.
METHODS


This first-in-human, proof-of-concept, double-blind, phase 1, randomised, placebo-controlled, dose-escalation trial was done at one clinical research centre in the UK. Healthy men aged 18-45 years without HIV infection were randomly assigned to receive intramuscular injection with rAAV1-PG9DP or placebo in the deltoid or quadriceps in one of four dose-escalating cohorts (group A, 4 × 10 12  vector genomes; group B, 4 × 10 13  vector genomes; group C, 8 × 10 13  vector genomes; and group D, 1·2 × 10 14  vector genomes). Volunteers were followed up for 48 weeks. The primary objective was to assess safety and tolerability. A secondary objective was to assess PG9 expression in serum and related HIV neutralisation activity. All volunteers were included in primary and safety analyses. The trial is complete and is registered with ClinicalTrials.gov, number NCT01937455.
FINDINGS


Between Jan 30, 2014, and Feb 28, 2017, 111 volunteers were screened for eligibility. 21 volunteers were eligible and provided consent, and all 21 completed 48 weeks of follow-up. Reactogenicity was generally mild or moderate and resolved without intervention. No probably or definitely related adverse events or serious adverse events were recorded. We detected PG9 by HIV neutralisation in the serum of four volunteers, and by RT-PCR in muscle biopsy samples from four volunteers. We did not detect PG9 by ELISA in serum. PG9 anti-drug antibody was present in ten volunteers in the higher dose groups. Both anti-AAV1 antibodies and AAV1-specific T-cell responses were detected.
INTERPRETATION


Future studies should explore higher doses of AAV, alternative AAV serotypes and gene expression cassettes, or other broadly neutralising HIV antibodies.
FUNDING


International AIDS Vaccine Initiative, United States Agency for International Development, Bill & Melinda Gates Foundation, US National Institutes of Health.",2019,"We detected PG9 by HIV neutralisation in the serum of four volunteers, and by RT-PCR in muscle biopsy samples from four volunteers.","['Healthy men aged 18-45 years without HIV infection', '21 volunteers were eligible and provided consent, and all 21 completed 48 weeks of follow-up', '1·2\u2008×', 'Between Jan 30, 2014, and Feb 28, 2017, 111 volunteers were screened for eligibility', 'healthy adults']","['intramuscular injection with rAAV1-PG9DP or placebo', 'rAAV1-PG9DP', 'Adeno-associated virus vectored immunoprophylaxis', 'placebo']","['adverse events or serious adverse events', 'safety and tolerability', 'PG9 expression in serum and related HIV neutralisation activity', 'Reactogenicity', 'PG9 anti-drug antibody']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042776', 'cui_str': 'Virus'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]",111.0,0.266159,"We detected PG9 by HIV neutralisation in the serum of four volunteers, and by RT-PCR in muscle biopsy samples from four volunteers.","[{'ForeName': 'Frances H', 'Initials': 'FH', 'LastName': 'Priddy', 'Affiliation': 'International AIDS Vaccine Initiative, New York, NY, USA. Electronic address: fpriddy@iavi.org.'}, {'ForeName': 'David J M', 'Initials': 'DJM', 'LastName': 'Lewis', 'Affiliation': 'NIHR Imperial Clinical Research Facility, Imperial College, London UK.'}, {'ForeName': 'Huub C', 'Initials': 'HC', 'LastName': 'Gelderblom', 'Affiliation': 'International AIDS Vaccine Initiative, New York, NY, USA.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Hassanin', 'Affiliation': 'Surrey Clinical Research Centre, University of Surrey, Guildford, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Streatfield', 'Affiliation': 'International AIDS Vaccine Initiative, London, UK.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'LaBranche', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hare', 'Affiliation': 'International AIDS Vaccine Initiative, London, UK.'}, {'ForeName': 'Josephine H', 'Initials': 'JH', 'LastName': 'Cox', 'Affiliation': 'International AIDS Vaccine Initiative, New York, NY, USA.'}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Dally', 'Affiliation': 'The Emmes Company, LLC, Rockville, MD, USA.'}, {'ForeName': 'Daryl', 'Initials': 'D', 'LastName': 'Bendel', 'Affiliation': 'Surrey Clinical Research Centre, University of Surrey, Guildford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Montefiori', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Eddy', 'Initials': 'E', 'LastName': 'Sayeed', 'Affiliation': 'International AIDS Vaccine Initiative, New York, NY, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Ackland', 'Affiliation': 'Global Biosolutions, Melbourne, Australia.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Gilmour', 'Affiliation': 'International AIDS Vaccine Initiative, London, UK.'}, {'ForeName': 'Bruce C', 'Initials': 'BC', 'LastName': 'Schnepp', 'Affiliation': ""Children's Hospital of Philadelphia.""}, {'ForeName': 'J Fraser', 'Initials': 'JF', 'LastName': 'Wright', 'Affiliation': ""Children's Hospital of Philadelphia.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Johnson', 'Affiliation': ""Children's Hospital of Philadelphia.""}]",The lancet. HIV,['10.1016/S2352-3018(19)30003-7']
278,31658115,Fresh Frozen Plasma versus Crystalloid Priming of Cardiopulmonary Bypass Circuit in Pediatric Surgery: A Randomized Clinical Trial.,"BACKGROUND


In congenital cardiac surgery, priming cardiopulmonary bypass (CPB) with fresh frozen plasma (FFP) is performed to prevent coagulation abnormalities. The hypothesis was that CPB priming with crystalloids would be different compared with FFP in terms of bleeding and/or need for blood product transfusion.
METHODS


In this parallel-arm double-blinded study, patients weighing between 7 and 15 kg were randomly assigned to a CPB priming with 15 ml · kg PlasmaLyte or 15 ml · kg FFP in addition to a predefined amount of packed red blood cells used in all patients. The decision to transfuse was clinical and guided by point-of-care tests. The primary endpoints included postoperative bleeding tracked by chest tubes, number of patients transfused with any additional blood products, and the total number of additional blood products administered intra- and postoperatively. The postoperative period included the first 6 h after intensive care unit arrival.
RESULTS


Respectively, 30 and 29 patients in the FFP and in the crystalloid group were analyzed in an intention-to-treat basis. Median postoperative blood loss was 7.1 ml · kg (5.1, 9.4) in the FFP group and 5.7 ml · kg (3.8, 8.5) in the crystalloid group (P = 0.219); difference (95% CI): 1.2 (-0.7 to 3.2). The proportion of patients additionally transfused was 26.7% (8 of 30) and 37.9% (11 of 29) in the FFP and the crystalloid groups, respectively (P = 0.355; odds ratio [95% CI], 1.7 [0.6 to 5.1]). The median number of any blood products transfused in addition to priming was 0 (0, 1) and 0 (0, 2) in the FFP and crystalloid groups, respectively (P = 0.254; difference [95% CI], 0 [0 to 0]). There were no study-related adverse events.
CONCLUSIONS


The results demonstrate that in infants and children, priming CPB with crystalloids does not result in a different risk of postoperative bleeding and need for transfusion of allogeneic blood products.",2020,"Median postoperative blood loss was 7.1 ml · kg (5.1, 9.4) in the FFP group and 5.7 ml · kg (3.8, 8.5) in the crystalloid group (P = 0.219); difference (95% CI): 1.2 (-0.7 to 3.2).","['patients undergoing pediatric cardiac surgery with cardiopulomonary bypass, postoperative bleeding', 'patients weighing between 7 and 15\u2009kg', 'Pediatric Surgery', 'pediatric cardiac surgical patients']","['FFP', 'cardiopulmonary bypass (CPB) with fresh frozen plasma (FFP', 'crystalloid versus fresh frozen plasma', 'CPB priming with 15\u2009ml · kg PlasmaLyte or 15\u2009ml · kg FFP', 'Fresh Frozen Plasma versus Crystalloid Priming of Cardiopulmonary Bypass Circuit']","['postoperative bleeding tracked by chest tubes, number of patients transfused with any additional blood products, and the total number of additional blood products administered intra- and postoperatively', 'median number of any blood products transfused', 'Median postoperative blood loss', 'proportion of patients additionally transfused']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0279077', 'cui_str': 'Pediatric surgery'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma (product)'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0018830', 'cui_str': 'Heart-Lung Machine'}]","[{'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456388', 'cui_str': 'Blood product (product)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.326017,"Median postoperative blood loss was 7.1 ml · kg (5.1, 9.4) in the FFP group and 5.7 ml · kg (3.8, 8.5) in the crystalloid group (P = 0.219); difference (95% CI): 1.2 (-0.7 to 3.2).","[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Dieu', 'Affiliation': 'From the Departments of Anesthesiology (A.D., M.R.M., A.M., D.K., C.K., M.M.) Hematology (S.E.) Cardiac Surgery (J.R., A.P.) Perfusion Services (D.T., A.G.) the Pediatric Intensive Care Unit (A.H., E.D.), University Hospital Saint Luc, Catholic University of Louvain (Cliniques Universitaires Saint Luc, Université Catholique de Louvain), Brussels, Belgium.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rosal Martins', 'Affiliation': ''}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Eeckhoudt', 'Affiliation': ''}, {'ForeName': 'Amine', 'Initials': 'A', 'LastName': 'Matta', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kahn', 'Affiliation': ''}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Khalifa', 'Affiliation': ''}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Rubay', 'Affiliation': ''}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Poncelet', 'Affiliation': ''}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Haenecour', 'Affiliation': ''}, {'ForeName': 'Emilien', 'Initials': 'E', 'LastName': 'Derycke', 'Affiliation': ''}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Thiry', 'Affiliation': ''}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Gregoire', 'Affiliation': ''}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Momeni', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003017']
279,32304734,Cetirizine inhibits gender-specific blood cell dynamics upon allergen contact in allergic rhinitis.,"IgE-mediated inflammatory responses upon allergen contact in allergic rhinitis (AR) are associated with rapid alterations of circulating blood cell numbers detectable in a complete blood count (CBC). Aim of this study was to evaluate whether intake of antihistamines may modulate allergen-induced CBC dynamics in male and female patients. A total of N = 112 specific allergen challenges were performed in otherwise healthy AR subjects. Seventy-two (n = 72) subjects received placebo and forty (n = 40) received cetirizine (H1-receptor antagonist) per os prior to allergen exposure in a randomized, double-blind trial at the Vienna Challenge Chamber (VCC); a subgroup of twenty-five (n = 25) subjects received cetirizine and placebo on different study days (parallel group). Blood samples and symptom scores were taken at baseline and immediately after 6 h of airway challenge simulating ambient allergen contact. Female sex was associated with a pronounced circulating monocyte increase (p < .01) and male sex with an eosinophil decrease (p < .05) in the placebo group, but not in cetirizine treated subjects. The significant increase in segmented neutrophils (p < .001) and decrease in circulating erythrocytes (p < .01) upon allergen challenge was less prominent after cetirizine intake in both sexes. A more prominent thrombocyte increase in female subjects (p < .05) was noted upon allergen exposure, regardless of prior cetirizine intake. Cetirizine inhibited the mobilization of neutrophils, lymphocytes and decline in erythrocyte numbers, but did not affect thrombocyte increase upon allergen challenge. It further diminished gender-specific blood cell dynamics. Overall, as reflected in a simple CBC, cetirizine critically diminished immediate and late innate immune responses subsequent to allergen exposure.",2020,The significant increase in segmented neutrophils (p < .001) and decrease in circulating erythrocytes (p < .01) upon allergen challenge was less prominent after cetirizine intake in both sexes.,"['allergic rhinitis', 'Seventy-two (n\u202f=\u202f72) subjects received', 'allergic rhinitis (AR', 'male and female patients', 'otherwise healthy AR subjects']","['cetirizine (H1-receptor antagonist) per os prior to allergen exposure', 'cetirizine and placebo', 'Cetirizine', 'antihistamines', 'placebo', 'cetirizine']","['circulating erythrocytes', 'segmented neutrophils', 'Blood samples and symptom scores', 'mobilization of neutrophils, lymphocytes and decline in erythrocyte numbers', 'circulating monocyte increase']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0055147', 'cui_str': 'Cetirizine'}, {'cui': 'C0034814', 'cui_str': 'Histamine H1 receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0229640', 'cui_str': 'Segmented neutrophil'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0553698', 'cui_str': 'Monocyte count increased'}]",72.0,0.125116,The significant increase in segmented neutrophils (p < .001) and decrease in circulating erythrocytes (p < .01) upon allergen challenge was less prominent after cetirizine intake in both sexes.,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Jordakieva', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Austria. Electronic address: galateja.jordakieva@meduniwien.ac.at.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kundi', 'Affiliation': 'Center for Public Health, Department of Environmental Health, Medical University of Vienna, Austria.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lemell', 'Affiliation': 'Power Project GmbH, Dept. Vienna Challenge Chamber (VCC), Austria.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Zieglmayer', 'Affiliation': 'Power Project GmbH, Dept. Vienna Challenge Chamber (VCC), Austria.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zieglmayer', 'Affiliation': 'Power Project GmbH, Dept. Vienna Challenge Chamber (VCC), Austria.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jensen-Jarolim', 'Affiliation': 'Institute of Pathophysiology and Allergy Research, Center of Pathophysiology, Infectiology and Immunology, Medical University of Vienna, Austria; The Interuniversity Messerli Research Institute, Medical University Vienna, University of Veterinary Medicine Vienna, University of Vienna, Austria.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Crevenna', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Austria.'}]","Clinical immunology (Orlando, Fla.)",['10.1016/j.clim.2020.108422']
280,32329089,Daytime masticatory muscle electromyography biofeedback regulates the phasic component of sleep bruxism.,"BACKGROUND


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


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


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


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


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


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


While the number of phasic EMG events was not significantly different between the BF and CO groups at baseline, significantly smaller phasic and tonic events were observed in the BF compared to the CO group at the follow-up session (week 3)","[{'ForeName': 'Konatsu', 'Initials': 'K', 'LastName': 'Saito-Murakami', 'Affiliation': 'Division of Fixed Prosthodontics, Department of Restorative & Biomaterials Sciences, Meikai University School of Dentistry, Sakado, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Sato', 'Affiliation': 'Division of Fixed Prosthodontics, Department of Restorative & Biomaterials Sciences, Meikai University School of Dentistry, Sakado, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Otsuka', 'Affiliation': 'Division of Fixed Prosthodontics, Department of Restorative & Biomaterials Sciences, Meikai University School of Dentistry, Sakado, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Miura', 'Affiliation': 'Division of Fixed Prosthodontics, Department of Restorative & Biomaterials Sciences, Meikai University School of Dentistry, Sakado, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Terada', 'Affiliation': 'Department of Biomedical Engineering, Faculty of Science and Engineering, Toyo University, Kawagoe, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Fujisawa', 'Affiliation': 'Division of Fixed Prosthodontics, Department of Restorative & Biomaterials Sciences, Meikai University School of Dentistry, Sakado, Japan.'}]",Journal of oral rehabilitation,['10.1111/joor.12979']
281,31601541,"Safety and immunogenicity of a multivalent HIV vaccine comprising envelope protein with either DNA or NYVAC vectors (HVTN 096): a phase 1b, double-blind, placebo-controlled trial.","BACKGROUND


Up to now, immunisation regimens that have been assessed for development of HIV vaccines have included purified envelope (Env) protein among the boosting components of the regimen. We postulated that co-administration of Env protein with either a DNA or NYVAC vector during priming would result in early generation of antibody responses to the Env V1/V2 region, which are important markers for effective protection against infection. We aimed to assess the safety and immunogenicity of a multivalent HIV vaccine including either DNA or NYVAC vectors alone or in combination with Env glycoprotein (gp120) followed by a co-delivered NYVAC and Env protein boost.
METHODS


We did a single-centre, double-blind, placebo-controlled phase 1b trial at the Centre Hospitalier Universitaire Vaudois (Lausanne, Switzerland). We included healthy volunteers aged 18-50 years who were at low risk of HIV infection. We randomly allocated participants using computer-generated random numbers to one of four vaccination schedules or placebo (4:1), and within these schedules participants were allocated either active treatment (T1, T2, T3, and T4) or placebo (C1, C2, C3, and C4). T1 consisted of two doses of NYVAC vector followed by two doses of NYVAC vector and gp120 Env protein; T2 comprised four doses of NYVAC vector and gp120 Env protein; T3 was two doses of DNA vector followed by two doses of NYVAC vector and gp120 Env protein; and T4 was two doses of DNA vector and gp120 Env protein followed by two doses of NYVAC vector and gp120 Env protein. Placebo injections were matched to the corresponding active treatment group. Doses were administered by injection at months 0, 1, 3, and 6. Primary outcomes were safety and immunogenicity of the vaccine schedules. Immune response measures included cross-clade and epitope-specific binding antibodies, neutralising antibodies, and antibody-dependent cell-mediated cytotoxicity measured 2 weeks after the month 1, 3, and 6 vaccinations. This trial is registered with ClinicalTrials.gov, NCT01799954.
FINDINGS


Between Aug 23, 2012, and April 18, 2013, 148 healthy adult volunteers were screened for the trial, of whom 96 participants were enrolled. 20 individuals were allocated to each active treatment group (groups T1-4; n=80) and four were assigned to each placebo group (groups C1-4; n=16). Vaccines containing the NYVAC vector (groups T1 and T2) were associated with more frequent severe reactogenicity and more adverse events than were vaccines containing the DNA vector (groups T3 and T4). The most frequent adverse events judged related to study product were lymphadenopathy (n=9) and hypoaesthesia (n=2). Two participants, one in the placebo group and one in the DNA-primed T3 group, had serious adverse events that were judged unrelated to study product. One participant in the T3 group died from cranial trauma after a motor vehicle accident. Across the active treatment groups, IgG responses 2 weeks after the 6-month dose of vaccine were 74-95%. Early administration of gp120 Env protein (groups T2 and T4) was associated with a substantially earlier and higher area under the curve for gp120 Env binding, production of anti-V1/V2 and neutralising antibodies, and better antibody-response coverage over a period of 18 months, compared with vaccination regimens that delayed administration of gp120 Env protein until the 3-month vaccination (groups T1 and T3).
INTERPRETATION


Co-administration of gp120 Env protein components with DNA or NYVAC vectors during priming led to early and potent induction of Env V1/V2 IgG binding antibody responses. This immunisation approach should be considered for induction of preventive antibodies in future HIV vaccine efficacy trials.
FUNDING


National Institutes of Health, National Institute of Allergy and Infectious Diseases, and the Bill & Melinda Gates Foundation.",2019,The most frequent adverse events judged related to study product were lymphadenopathy (n=9) and hypoaesthesia (n=2).,"['Between Aug 23, 2012, and April 18, 2013', '148 healthy adult volunteers were screened for the trial, of whom 96 participants were enrolled', '20 individuals', 'healthy volunteers aged 18-50 years who were at low risk of HIV infection']","['Placebo', 'DNA or NYVAC vectors alone or in combination with Env glycoprotein (gp120) followed by a co-delivered NYVAC and Env protein boost', 'placebo (C1, C2, C3, and C4', 'placebo', 'gp120 Env protein', 'multivalent HIV vaccine', 'DNA or NYVAC vector']","['safety and immunogenicity of the vaccine schedules', 'adverse events', 'safety and immunogenicity', 'Immune response measures included cross-clade and epitope-specific binding antibodies, neutralising antibodies, and antibody-dependent cell-mediated cytotoxicity', 'serious adverse events']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0442335', 'cui_str': 'Vectors (qualifier value)'}, {'cui': 'C0282397', 'cui_str': 'env Glycoproteins'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0017278', 'cui_str': 'env Protein'}, {'cui': 'C0019691', 'cui_str': 'Envelope Glycoprotein gp120, HIV'}, {'cui': 'C0086413'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0003316', 'cui_str': 'Antigenic Determinants'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0301896', 'cui_str': 'Cell-mediated lympholysis, function (observable entity)'}]",148.0,0.354877,The most frequent adverse events judged related to study product were lymphadenopathy (n=9) and hypoaesthesia (n=2).,"[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pantaleo', 'Affiliation': 'Service of Immunology and Allergy, and Swiss Vaccine Research Institute, Lausanne University Hospital, Lausanne, Switzerland. Electronic address: giuseppe.pantaleo@chuv.ch.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Janes', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Karuna', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Grant', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'G Laissa', 'Initials': 'GL', 'LastName': 'Ouedraogo', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA; US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Allen', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Department of Surgery, Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Frahm', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Bill & Melinda Gates Medical Research Institute, Cambridge, MA, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Montefiori', 'Affiliation': 'Department of Surgery, Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Ferrari', 'Affiliation': 'Department of Surgery, Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Ding', 'Affiliation': 'EuroVacc Foundation, Lausanne, Switzerland.'}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Global Solutions for Infectious Diseases, South San Francisco, CA, USA.'}, {'ForeName': 'Merlin L', 'Initials': 'ML', 'LastName': 'Robb', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Esteban', 'Affiliation': 'Department of Molecular and Cellular Biology, Centro Nacional de Biotecnología, Consejo Superior de Investigaciones Científicas, Madrid, Spain.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Wagner', 'Affiliation': 'Institute of Medical Microbiology and Hygiene, University of Regensburg, Regensburg, Germany; Institute of Clinical Microbiology and Hygiene, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Pierre-Alexandre', 'Initials': 'PA', 'LastName': 'Bart', 'Affiliation': 'Service of Immunology and Allergy, and Swiss Vaccine Research Institute, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Rettby', 'Affiliation': 'Service of Immunology and Allergy, and Swiss Vaccine Research Institute, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Gilbert', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(19)30262-0']
282,32324592,Therapeutic options for advanced epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer: a Bayesian network secondary analysis.,"The most favorable treatments for advanced EGFR-mutant NSCLC are less indicated. Forty-one studies were eligible for this Bayesian network secondary analysis. For PFS, erlotinib (Erlo)+bevacizumab (Bev) (HR 0.26, 95% CrI: 0.08-0.75 vs placebo), osimertinib (Osi) (HR 0.29, 0.11-0.70 vs placebo), and afatinib (Afa) were top-ranking individual treatments, while immunotherapy (IT)+anti-VEGFR (aVEGFR)+platinum-based therapy (Plat) (HR 0.42, 0.06-2.63 vs placebo), EGFR-TKI (ET)+aVEGFR (HR 0.35, 0.14-0.85 vs placebo), and ET+aVEGFR+Plat were top-ranking medication classes. For OS, Osi (HR 0.52, 0.10-2.00 vs placebo), cetuximab (Cet)+Bev+Plat (HR 0.51, 0.06-3.38 vs placebo), and cilengitide (Cil)+Cet+Plat were top-ranking individual treatments, while ET+aVEGFR+Plat, ET+Plat, and third-generation EGFR-TKI (3 rd  ET) were top-ranking medication classes. For PFS regarding the EGFR genomic aberration status, Erlo+Bev, Osi, and Afa were superior for exon 19 deletion status, whereas ET+Bev, Osi, and gefitinib (Gef)+pemetrexed (Peme) were excellent for exon 21 L858Arg mutation status. The results were consistent in terms of the ORR and DoR and remained robust across sensitivity analyses. However, Erlo + Bev had the most grade 3 or higher adverse events. Osi, Erlo+Bev, and Erlo+Bev+Plat are reasonably recommended to balance PFS and OS, but adverse events should be considered. IT+aVEGFR+Plat shows potential superiority, but more clinical evidence is needed.",2020,"For OS, Osi (HR 0.52, 0.10-2.00 vs placebo), cetuximab (Cet)+Bev+Plat (HR 0.51, 0.06-3.38 vs placebo), and cilengitide (Cil)+Cet+Plat were top-ranking individual treatments, while ET+aVEGFR+Plat, ET+Plat, and third-generation EGFR-TKI (3 rd  ET) were top-ranking medication classes.","['advanced epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer', 'advanced EGFR-mutant']","['placebo), EGFR-TKI (ET)+aVEGFR', 'IT+aVEGFR+Plat']","['ET+Bev, Osi, and gefitinib (Gef)+pemetrexed (Peme', 'ORR and DoR']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0148199', 'cui_str': 'Vascular Endothelial Growth Factor Receptor'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0140057', 'cui_str': 'delta Opioid Receptor'}]",,0.115238,"For OS, Osi (HR 0.52, 0.10-2.00 vs placebo), cetuximab (Cet)+Bev+Plat (HR 0.51, 0.06-3.38 vs placebo), and cilengitide (Cil)+Cet+Plat were top-ranking individual treatments, while ET+aVEGFR+Plat, ET+Plat, and third-generation EGFR-TKI (3 rd  ET) were top-ranking medication classes.","[{'ForeName': 'Xinmin', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'Department of Thoracic Surgery, Nanchang First Hospital, Nanchang 330008, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Nanchang University, Nanchang 330006, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Oncology, Nanchang First Hospital, Nanchang 330008, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic Surgery, Nanchang First Hospital, Nanchang 330008, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Nanchang First Hospital, Nanchang 330008, China.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Zeng', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Nanchang University, Nanchang 330006, China.'}, {'ForeName': 'Wenxiong', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Surgery, The Second Affiliated Hospital of Nanchang University, Nanchang 330006, China.'}, {'ForeName': 'Binghao', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurosurgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.'}]",Aging,['10.18632/aging.103066']
283,32307009,Effectiveness of Group Problem Management Plus (Group-PM+) for adults affected by humanitarian crises in Nepal: study protocol for a cluster randomized controlled trial.,"BACKGROUND


Globally, the lack of availability of psychological services for people exposed to adversities has led to the development of a range of scalable psychological interventions with features that enable better scale-up. Problem Management Plus (PM+) is a brief intervention of five sessions that can be delivered by non-specialists. It is designed for people in communities in low- and middle-income countries (LMIC) affected by any kind of adversity. Two recent randomized controlled trials in Pakistan and Kenya demonstrated the effectiveness of individually delivered PM+. A group version of PM+ has been developed to make the intervention more scalable and acceptable. This paper describes the protocol for a cluster randomized controlled trial (c-RCT) on locally adapted Group PM+ in Nepal.
METHODS/DESIGN


This c-RCT will compare Group PM+ to enhanced usual care (EUC) in participants with high levels of psychological distress recruited from the community. The study is designed as a two-arm, single-blind c-RCT that will be conducted in a community-based setting in Morang, a flood affected district in Eastern Nepal. Randomization will occur at ward level, the smallest administrative level in Nepal, with 72 enrolled wards allocated to Group PM+ or to EUC (ratio 1:1). Group PM+ consists of five approximately 2.5-h sessions, in which participants are taught techniques to manage their stressors and problems, and is delivered by trained and supervised community psychosocial workers (CPSWs). EUC consists of a family meeting with (a) basic information on adversity and mental health, (b) benefits of getting support, (c) information on seeking services from local health facilities with mhGAP-trained staff. The primary outcome measure is levels of individual psychological distress at endline (equivalent to 20 ± 1 weeks after baseline), measured by the General Health Questionnaire (GHQ-12). Secondary outcome measures include levels of functioning, depressive symptoms, post-traumatic stress disorder symptoms, levels of social support, somatic symptoms, and ways of coping. We hypothesize that skills acquired will mediate any impact of the intervention.
DISCUSSION


This c-RCT will contribute to the growing evidence-base for transdiagnostic psychological interventions delivered by non-specialists for people in communities affected by adversity. If Group PM+ is proven effective, the intervention manual will be released for use, giving the opportunity for further adaptation and implementation of the intervention in diverse settings with communities that require better access to psychological interventions.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03747055.",2020,Problem Management Plus,"['adults affected by humanitarian crises in Nepal', 'participants with high levels of psychological distress recruited from the community', 'seeking services from local health facilities with mhGAP-trained staff', 'community-based setting in Morang, a flood affected district in Eastern Nepal']","['Group Problem Management Plus', 'PM']","['levels of functioning, depressive symptoms, post-traumatic stress disorder symptoms, levels of social support, somatic symptoms, and ways of coping', 'levels of individual psychological distress at endline (equivalent to 20\u2009±\u20091\u2009weeks after baseline), measured by the General Health Questionnaire (GHQ-12']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0016248', 'cui_str': 'Flood'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire'}]",72.0,0.156326,Problem Management Plus,"[{'ForeName': 'Edith', 'Initials': 'E', 'LastName': ""Van't Hof"", 'Affiliation': 'Department of Mental Health and Substance Use, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Manaswi', 'Initials': 'M', 'LastName': 'Sangraula', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Baluwatar, Kathmandu, Nepal.'}, {'ForeName': 'Nagendra P', 'Initials': 'NP', 'LastName': 'Luitel', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Baluwatar, Kathmandu, Nepal. luitelnp@gmail.com.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Department of Biostatistics and Bioinformatics and Duke Global Health Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Kedar', 'Initials': 'K', 'LastName': 'Marahatta', 'Affiliation': 'World Health Organization, Country Office for Nepal, Kathmandu, Nepal.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van Ommeren', 'Affiliation': 'Department of Mental Health and Substance Use, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Pragya', 'Initials': 'P', 'LastName': 'Shrestha', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Baluwatar, Kathmandu, Nepal.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bryant', 'Affiliation': 'University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Kohrt', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Baluwatar, Kathmandu, Nepal.'}, {'ForeName': 'Mark J D', 'Initials': 'MJD', 'LastName': 'Jordans', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Baluwatar, Kathmandu, Nepal.'}]",Trials,['10.1186/s13063-020-04263-9']
284,30858518,Lithium continuation therapy following ketamine in patients with treatment resistant unipolar depression: a randomized controlled trial.,"The N-methyl-D-aspartate (NMDA) receptor antagonist ketamine is associated with rapid but transient antidepressant effects in patients with treatment resistant unipolar depression (TRD). Based on work suggesting that ketamine and lithium may share overlapping mechanisms of action, we tested lithium compared to placebo as a continuation strategy following ketamine in subjects with TRD. Participants who met all eligibility criteria and showed at least an initial partial response to a single intravenous infusion of ketamine 0.5 mg/kg were randomized under double-blind conditions to lithium or matching placebo before receiving an additional three infusions of ketamine. Subsequent to the ketamine treatments, participants remained on lithium or placebo during a double-blind continuation phase. The primary study outcome was depression severity as measured by the Montgomery-Åsberg Depression Rating Scale compared between the two groups at Study Day 28, which occurred ~2 weeks following the final ketamine of four infusions. Forty-seven participants with TRD were enrolled in the study and underwent an initial ketamine infusion, of whom 34 participants were deemed to have at least a partial antidepressant response and were eligible for randomization. Comparison between treatment with daily oral lithium (n = 18) or matching placebo (n = 16) at the primary outcome showed no difference in depression severity between groups (t 32  = 0.11, p = 0.91, 95% CI [-7.87, 8.76]). There was no difference between lithium and placebo in continuing the acute antidepressant response to ketamine. The identification of a safe and effective strategy for preventing depression relapse following an acute course of ketamine treatment remains an important goal for future studies.",2019,There was no difference between lithium and placebo in continuing the acute antidepressant response to ketamine.,"['Participants who met all eligibility criteria and showed at least an initial partial response to a single intravenous infusion of ketamine 0.5\u2009mg/kg', 'subjects with TRD', 'patients with treatment resistant unipolar depression (TRD', 'patients with treatment resistant unipolar depression', 'Forty-seven participants with TRD were enrolled in the study and underwent an initial ketamine infusion, of whom 34 participants were deemed to have at least a partial antidepressant response and were eligible for randomization']","['ketamine', 'matching placebo', 'ketamine and lithium', 'placebo', 'lithium or placebo', 'daily oral lithium', 'N-methyl-D-aspartate (NMDA) receptor antagonist ketamine', 'Lithium continuation therapy', 'lithium and placebo', 'lithium or matching placebo']","['depression severity', 'depression severity as measured by the Montgomery-Åsberg Depression Rating Scale']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0041696', 'cui_str': 'Unipolar Depression'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3540800', 'cui_str': 'Lithium'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4521484', 'cui_str': 'N-methyl-D-aspartate receptor antagonist (disposition)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}]",34.0,0.668127,There was no difference between lithium and placebo in continuing the acute antidepressant response to ketamine.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Costi', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Laili', 'Initials': 'L', 'LastName': 'Soleimani', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Glasgow', 'Affiliation': 'Department of Anesthesiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Jess', 'Initials': 'J', 'LastName': 'Brallier', 'Affiliation': 'Department of Anesthesiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Spivack', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Schwartz', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Cara F', 'Initials': 'CF', 'LastName': 'Levitch', 'Affiliation': 'Department of Psychology, Fordham University, Bronx, NY, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Richards', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Hoch', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Wade', 'Affiliation': 'Department of Psychology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Welch', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Collins', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Feder', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Dennis S', 'Initials': 'DS', 'LastName': 'Charney', 'Affiliation': 'Department of Neuroscience, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Murrough', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA. james.murrough@mssm.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0365-0']
285,31699517,"Effects of Sodium Bicarbonate in CKD Stages 3 and 4: A Randomized, Placebo-Controlled, Multicenter Clinical Trial.","RATIONALE & OBJECTIVE


Metabolic acidosis associated with chronic kidney disease (CKD) may contribute to muscle dysfunction and bone disease. We aimed to test whether treatment with sodium bicarbonate improves muscle and bone outcomes.
STUDY DESIGN


Multicenter, randomized, placebo-controlled, clinical trial.
SETTING & PARTICIPANTS


149 patients with CKD stages 3 and 4 between July 2011 and April 2016 at 3 centers in Cleveland, OH, and the Bronx, NY.
INTERVENTION


Sodium bicarbonate (0.4 mEq per kg of ideal body weight per day) (n=74) or identical-appearing placebo (n=75).
OUTCOMES


Dual primary outcomes were muscle function assessed using sit-to-stand test and bone mineral density. Muscle biopsies were performed at baseline and 2 months. Participants were seen at baseline and 2, 6, 12, and 24 months.
RESULTS


Mean baseline serum bicarbonate level was 24.0±2.2 (SD) mEq/L and mean baseline estimated glomerular filtration rate was 36.3±11.2mL/min/1.73m 2 . Baseline characteristics did not differ between groups. Mean serum bicarbonate levels in the intervention arm during follow-up were 26.4±2.2, 25.5±2.3, 25.6±2.6, and 24.4±2.8 mEq/L (at 2, 6, 12, and 24 months). These were significantly higher than in the placebo group (P<0.001). Compared to the placebo group, participants randomly assigned to sodium bicarbonate treatment had no significant differences in sit-to-stand time (5 repetitions: P=0.1; and 10 repetitions P=0.07) or bone mineral density (P=0.3). Sodium bicarbonate treatment caused a decrease in serum potassium levels that was of borderline statistical significance (P=0.05). There were no significant differences in estimated glomerular filtration rates, blood pressure, weight, serious adverse events, or levels of muscle gene expression between the randomly assigned groups.
LIMITATIONS


Initial mean serum bicarbonate level was in the normal range.
CONCLUSIONS


Sodium bicarbonate therapy in patients with CKD stages 3 and 4 significantly increases serum bicarbonate and decreases potassium levels. No differences were found in muscle function or bone mineral density between the randomly assigned groups. Larger trials are required to evaluate effects on kidney function.
FUNDING


National Institutes of Health grant.
TRIAL REGISTRATION


Registered at ClinicalTrials.gov with study number NCT01452412.",2020,"Compared to the placebo group, participants randomly assigned to sodium bicarbonate treatment had no significant differences in sit-to-stand time (5 repetitions: P=0.1; and 10 repetitions P=0.07) or bone mineral density (P=0.3).","['149 patients with CKD stages 3 and 4 between July 2011 and April 2016 at 3 centers in Cleveland, OH, and the Bronx, NY', 'CKD Stages 3 and 4', 'chronic kidney disease (CKD']","['Placebo', 'Sodium bicarbonate', 'sodium bicarbonate', 'Sodium Bicarbonate', 'placebo', 'Sodium bicarbonate therapy', 'identical-appearing placebo']","['muscle function assessed using sit-to-stand test and bone mineral density', 'Mean serum bicarbonate levels', 'muscle and bone outcomes', 'estimated glomerular filtration rates, blood pressure, weight, serious adverse events, or levels of muscle gene expression', 'serum potassium levels', 'muscle function or bone mineral density', 'Mean baseline serum bicarbonate level', 'bone mineral density', 'serum bicarbonate level', 'sit-to-stand time', 'glomerular filtration rate', 'serum bicarbonate and decreases potassium levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2316787', 'cui_str': 'CKD stage 3'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454845', 'cui_str': 'Cleveland (geographic location)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}]","[{'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C3811844'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0428289', 'cui_str': 'Finding of potassium level (finding)'}]",149.0,0.375377,"Compared to the placebo group, participants randomly assigned to sodium bicarbonate treatment had no significant differences in sit-to-stand time (5 repetitions: P=0.1; and 10 repetitions P=0.07) or bone mineral density (P=0.3).","[{'ForeName': 'Michal L', 'Initials': 'ML', 'LastName': 'Melamed', 'Affiliation': 'Department of Medicine (Nephrology), Albert Einstein College of Medicine/ Montefiore Medical Center, Bronx, NY; Department of Epidemiology & Population Health, Albert Einstein College of Medicine, Bronx, NY. Electronic address: michal.melamed@einstein.yu.edu.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Horwitz', 'Affiliation': 'Department of Medicine (Nephrology), MetroHealth Medical Center, Cleveland, OH.'}, {'ForeName': 'Mirela A', 'Initials': 'MA', 'LastName': 'Dobre', 'Affiliation': 'Department of Medicine (Nephrology), Case Western Reserve University/University Hospitals Cleveland Medical Center, Cleveland, OH.'}, {'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': 'Abramowitz', 'Affiliation': 'Department of Medicine (Nephrology), Albert Einstein College of Medicine/ Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Medicine (Nephrology), Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Yungtai', 'Initials': 'Y', 'LastName': 'Lo', 'Affiliation': 'Department of Epidemiology & Population Health, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Mitch', 'Affiliation': 'Department of Medicine (Nephrology), Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Hostetter', 'Affiliation': 'Department of Medicine (Nephrology), Case Western Reserve University/University Hospitals Cleveland Medical Center, Cleveland, OH.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2019.07.016']
286,31666688,"Inhaled nitric oxide as an adjunct to neonatal resuscitation in premature infants: a pilot, double blind, randomized controlled trial.","BACKGROUND


Nitric oxide (NO) plays an important role in normal postnatal transition. Our aims were to determine whether adding inhaled NO (iNO) decreases supplemental oxygen exposure in preterm infants requiring positive pressure ventilation (PPV) during resuscitation and to study iNO effects on heart rate (HR), oxygen saturation (SpO 2 ), and need for intubation during the first 20 min of life.
METHODS


This was a pilot, double-blind, randomized, placebo-controlled trial. Infants 25 0/7-31 6/7 weeks' gestational age requiring PPV with supplemental oxygen during resuscitation were enrolled. PPV was initiated with either oxygen (FiO 2 -0.30) + iNO at 20 ppm (iNO group) or oxygen (FiO 2 -0.30) + nitrogen (placebo group). Oxygen was titrated targeting defined SpO 2  per current guidelines. After 10 min, iNO/nitrogen was weaned stepwise per protocol and terminated at 17 min.
RESULTS


Twenty-eight infants were studied (14 per group). The mean gestational age in both groups was similar. Cumulative FiO 2  and rate of exposure to high FiO 2  (>0.60) were significantly lower in the iNO group. There were no differences in HR, SpO 2 , and need for intubation.
CONCLUSIONS


Administration of iNO as an adjunct during neonatal resuscitation is feasible without side effects. It diminishes exposure to high levels of supplemental oxygen.",2020,Cumulative FiO 2  and rate of exposure to high FiO 2  (>0.60) were significantly lower in the iNO group.,"['premature infants', 'preterm infants requiring positive pressure ventilation (PPV', ""Infants 25 0/7-31 6/7 weeks' gestational age requiring PPV with supplemental oxygen during resuscitation were enrolled""]","['placebo', 'inhaled NO (iNO', 'Inhaled nitric oxide', 'oxygen (FiO 2 -0.30)\u2009+\u2009iNO at 20\u2009ppm (iNO group) or oxygen (FiO 2 -0.30)\u2009+\u2009nitrogen (placebo']","['mean gestational age', 'heart rate (HR), oxygen saturation (SpO 2 ), and need for intubation', 'Cumulative FiO 2  and rate of exposure to high FiO 2', 'HR, SpO 2 , and need for intubation']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C3266857', 'cui_str': 'Positive-Pressure Ventilation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",28.0,0.552969,Cumulative FiO 2  and rate of exposure to high FiO 2  (>0.60) were significantly lower in the iNO group.,"[{'ForeName': 'Krishnamurthy', 'Initials': 'K', 'LastName': 'Sekar', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA. Kris-Sekar@ouhsc.edu.'}, {'ForeName': 'Edgardo', 'Initials': 'E', 'LastName': 'Szyld', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McCoy', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Wlodaver', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Dannaway', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Helmbrecht', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Julee', 'Initials': 'J', 'LastName': 'Riley', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Manfredo', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Anderson', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Satyan', 'Initials': 'S', 'LastName': 'Lakshminrusimha', 'Affiliation': 'Department of Pediatrics, UC Davis Health, Sacramento, CA, USA.'}, {'ForeName': 'Shahab', 'Initials': 'S', 'LastName': 'Noori', 'Affiliation': ""Fetal and Neonatal Institute, Division of Neonatology, Children's Hospital of Los Angeles, Department of Pediatrics, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.""}]",Pediatric research,['10.1038/s41390-019-0643-x']
287,32375800,Visual rehabilitation of patients with corneal diseases.,"BACKGROUND


Although most patients with visual impairment due to corneal diseases can be treated successfully with surgery, some require visual rehabilitation to restore reading ability. To evaluate the best LVAs especially in terms of reading speed and characterize this specific patient group we performed a prospective, randomized cross-over trial.
METHODS


All 34 patients underwent a detailed examination (slit-lamp, funduscopy, SD-OCT, ETDRS) as screening. Only patients with corneal diseases without other ocular diseases were included. Reading-speed was assessed with International-Reading-Speed-Texts (IReST) consecutively with five different LVAs (low vision aids) during one day in a randomized cross-over design. Corneal haze was quantified with corneal densitometry (Pentacam).
RESULTS


Patients were either visually impaired (n = 28), severely impaired (n = 4) or legally blind (n = 2). Patients read significantly faster with LVAs (p < 0.0001). Fastest reading speed could be achieved with video magnifier (CCTV). Optical magnifier and portable-electronic magnifier enabled significantly lower reading speeds (p < 0.01). In a subgroup of patients (VA < 3/60,n = 6) black background enabled patients to read significantly faster compared to white background (p = 0.03).
CONCLUSION


Patients with low magnification requirement can be treated successfully with optical LVAs and portable-electronic magnifiers. More severely afflicted patients need a CCTV. Black background enables fastest reading-speeds, probably due to less blinding. Visual impairment can be estimated with corneal densitometry. Our trial confirms the capability of LVAs to successfully restore the reading ability in patients with corneal diseases, which is a crucial part of visual rehabilitation.
TRIAL REGISTRATION


This trial was registered at the German Clinical Trials Register as DRKS00010887 at 09.08.2016.",2020,Optical magnifier and portable-electronic magnifier enabled significantly lower reading speeds (p < 0.01).,"['patients with visual impairment due to corneal diseases', 'patients with corneal diseases', 'Only patients with corneal diseases without other ocular diseases', 'Patients were either visually impaired (n\xa0=\u200928), severely impaired (n\xa0=\u20094) or legally blind (n\xa0=\u20092']",['Reading-speed was assessed with International-Reading-Speed-Texts (IReST) consecutively with five different LVAs (low vision aids'],"['reading speeds', 'Visual rehabilitation', 'Corneal haze']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042798', 'cui_str': 'Dim vision'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0010034', 'cui_str': 'Disorder of cornea'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0733778', 'cui_str': 'Low vision aid'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0200251', 'cui_str': 'Blind rehabilitation therapy'}, {'cui': 'C0010038', 'cui_str': 'Corneal opacity'}]",34.0,0.108339,Optical magnifier and portable-electronic magnifier enabled significantly lower reading speeds (p < 0.01).,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Oeverhaus', 'Affiliation': 'Department of Ophthalmology, University Hospital Essen, Hufelandstr. 55, 45147, Essen, Germany. michael.oeverhaus@uk-essen.de.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Dekowski', 'Affiliation': 'Department of Ophthalmology, University Hospital Essen, Hufelandstr. 55, 45147, Essen, Germany.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Hirche', 'Affiliation': 'Institute of Medical Informatics, Biometry and Epidemiology, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Esser', 'Affiliation': 'Department of Ophthalmology, University Hospital Essen, Hufelandstr. 55, 45147, Essen, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Schaperdoth-Gerlings', 'Affiliation': 'Department of Ophthalmology, University Hospital Essen, Hufelandstr. 55, 45147, Essen, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Eckstein', 'Affiliation': 'Department of Ophthalmology, University Hospital Essen, Hufelandstr. 55, 45147, Essen, Germany.'}]",BMC ophthalmology,['10.1186/s12886-020-01436-7']
288,30477961,"Substitution of ethambutol with linezolid during the intensive phase of treatment of pulmonary tuberculosis: a prospective, multicentre, randomised, open-label, phase 2 trial.","BACKGROUND


Linezolid improves the treatment outcomes of multidrug-resistant tuberculosis substantially. We investigated whether use of linezolid instead of ethambutol increases the proportion of sputum culture conversion at 8 weeks of treatment in patients with pulmonary tuberculosis.
METHODS


We did a phase 2, multicentre, randomised, open-label trial for patients with pulmonary tuberculosis at the three affiliated hospitals to Seoul National University and National Medical Center (Seoul-Seongnam, South Korea). Patients, aged 20-80 years, with a positive sputum for pulmonary tuberculosis, but without resistance to rifampicin, and current treatment administered for 7 days or fewer, were randomly assigned at a 1:1:1 ratio into three groups. The control group received ethambutol (2 months) with isoniazid, rifampicin, and pyrazinamide. The second group used linezolid (600 mg/day) for 2 weeks and the third group for 4 weeks instead of ethambutol for 2 months. We used a minimisation method to randomise, and stratified according to institution, cavitation on chest radiographs, and diabetes. The primary endpoint was the proportion of patients with negative culture conversion of sputum in liquid media after 8 weeks of treatment. The results of this trial were analysed primarily in the modified intention-to-treat population. The trial is registered with ClinicalTrials.gov, number NCT01994460.
FINDINGS


Between Feb 19, 2014, and Jan 13, 2017, a total of 429 patients were enrolled and 428 were randomly assigned into either the control group (142 patients), the linezolid 2 weeks group (143 patients), or the linezolid 4 weeks group (143 patients). Among them, 401 were eligible for primary efficacy analyses. In the modified intention-to-treat analyses, negative cultures in liquid media at 8 weeks of treatment were observed in 103 (76·9%) of 134 control patients, 111 (82·2%) of 135 in the linezolid 2 weeks group, and 100 (75·8%) of 132 in the linezolid 4 weeks groups. The difference from the control group was 5.4% (95% CI -4·3 to 15·0, p=0·28) for the linezolid 2 weeks group and -1·1% (-11·3 to 9·1, p=0·83) for the linezolid 4 weeks group. Numbers of patients who experienced at least one adverse event were similar across the groups (86 [62·8%] of 137 in control, 79 [57·2%] of 138 in the linezolid 2 weeks group, and 75 [62·0%] of 121 in the linezolid 4 weeks group). Resistance to linezolid was not identified in any patient.
INTERPRETATION


Higher rates of culture conversion at 8 weeks of treatment with short-term use of linezolid were not observed. However, safety analyses and the resistance profile suggested the potential role of linezolid in shortening of treatment for drug-susceptible tuberculosis.
FUNDING


Ministry of Health and Welfare, South Korea.",2019,"The difference from the control group was 5.4% (95% CI -4·3 to 15·0, p=0·28) for the linezolid 2 weeks group and -1·1% (-11·3 to 9·1, p=0·83) for the linezolid 4 weeks group.","['pulmonary tuberculosis', 'patients with pulmonary tuberculosis at the three affiliated hospitals to Seoul National University and National Medical Center (Seoul-Seongnam, South Korea', 'patients with pulmonary tuberculosis', 'Between Feb 19, 2014, and Jan 13, 2017, a total of 429 patients were enrolled and 428', 'Patients, aged 20-80 years, with a positive sputum for pulmonary tuberculosis, but without resistance to rifampicin, and current treatment administered for 7 days or fewer']","['Linezolid', 'linezolid', 'isoniazid, rifampicin, and pyrazinamide']","['proportion of sputum culture conversion', 'adverse event', 'proportion of patients with negative culture conversion of sputum in liquid media']","[{'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517775', 'cui_str': 'Four hundred and twenty-eight'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}]","[{'cui': 'C0663241', 'cui_str': 'linezolid'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}]","[{'cui': 'C0523174', 'cui_str': 'Microbial culture of sputum (procedure)'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}]",429.0,0.0384569,"The difference from the control group was 5.4% (95% CI -4·3 to 15·0, p=0·28) for the linezolid 2 weeks group and -1·1% (-11·3 to 9·1, p=0·83) for the linezolid 4 weeks group.","[{'ForeName': 'Jung-Kyu', 'Initials': 'JK', 'LastName': 'Lee', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, South Korea.'}, {'ForeName': 'Ji Yeon', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, National Medical Center, Seoul, South Korea.'}, {'ForeName': 'Deog Kyeom', 'Initials': 'DK', 'LastName': 'Kim', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, South Korea; Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ho Il', 'Initials': 'HI', 'LastName': 'Yoon', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea; Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Jeong', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, National Medical Center, Seoul, South Korea.'}, {'ForeName': 'Eun Young', 'Initials': 'EY', 'LastName': 'Heo', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, South Korea.'}, {'ForeName': 'Young Sik', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Yong Suk', 'Initials': 'YS', 'LastName': 'Jo', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Jae Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea; Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sung Soo', 'Initials': 'SS', 'LastName': 'Park', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, South Korea.'}, {'ForeName': 'Jong Sun', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Junghyun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, National Medical Center, Seoul, South Korea.'}, {'ForeName': 'Sang-Min', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea; Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Joon-Sung', 'Initials': 'JS', 'LastName': 'Joh', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, National Medical Center, Seoul, South Korea.'}, {'ForeName': 'Chang-Hoon', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Jinwoo', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Sun Mi', 'Initials': 'SM', 'LastName': 'Choi', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Ju-Hee', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, South Korea.'}, {'ForeName': 'Sang Hoon', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Young-Jae', 'Initials': 'YJ', 'LastName': 'Cho', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Yeon Joo', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Se Joong', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Nakwon', 'Initials': 'N', 'LastName': 'Kwak', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Yong Ran', 'Initials': 'YR', 'LastName': 'Hwang', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, South Korea.'}, {'ForeName': 'Hyeonjeong', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Jongeun', 'Initials': 'J', 'LastName': 'Ki', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, National Medical Center, Seoul, South Korea.'}, {'ForeName': 'Ji Na', 'Initials': 'JN', 'LastName': 'Lim', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, National Medical Center, Seoul, South Korea.'}, {'ForeName': 'Hyoung Sook', 'Initials': 'HS', 'LastName': 'Choi', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Myungsun', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'International TB Research Center, Seoul, South Korea.'}, {'ForeName': 'Taeksun', 'Initials': 'T', 'LastName': 'Song', 'Affiliation': 'International TB Research Center, Seoul, South Korea.'}, {'ForeName': 'Hyun Su', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Medical Research Collaborating Center, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Jiyeon', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Medical Research Collaborating Center, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Heejung', 'Initials': 'H', 'LastName': 'Ahn', 'Affiliation': 'Medical Research Collaborating Center, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Seokyung', 'Initials': 'S', 'LastName': 'Hahn', 'Affiliation': 'Medical Research Collaborating Center, Seoul National University Hospital, Seoul, South Korea; Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jae-Joon', 'Initials': 'JJ', 'LastName': 'Yim', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea; Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea. Electronic address: yimjj@snu.ac.kr.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30480-8']
289,30628813,Naltrexone and alcohol effects on craving for cigarettes in heavy drinking smokers.,"Naltrexone has been extensively studied for the treatment of alcohol use disorder. However, less is known about the effects of naltrexone on smoking outcomes in the context of alcohol use among East Asian individuals who have been suggested to differ in response to alcohol and to naltrexone. The present study is a secondary analysis that used a double-blind placebo-controlled design (n = 31) to examine the (a) effects of alcohol on basal craving for cigarettes, (b) effects of naltrexone on cigarette craving and alcohol craving during alcohol administration, and (c) relationship between craving for alcohol and cigarettes. Heavy drinking smokers of East Asian descent completed two counterbalanced intravenous alcohol administration sessions, one after taking naltrexone (50 mg) for five days and one after taking a placebo for five days. Self-reported subjective craving for cigarettes and for alcohol was recorded during each experimental session. Craving for cigarettes and alcohol increased significantly throughout the intravenous alcohol administration. A significant breath alcohol concentration (BrAC) × Medication interaction revealed that naltrexone blunted cigarette craving during alcohol administration, compared to placebo. Naltrexone significantly reduced craving for alcohol during alcohol administration in this group of heavy drinking smokers. Alcohol craving significantly predicted cigarette craving, however this effect did not vary across rising alcohol administration or by medication. These findings demonstrate that naltrexone reduces the urge to smoke and to drink during alcohol administration. Clinical studies are needed to further ascertain whether naltrexone may be of benefit to this distinct subgroup of heavy drinking smokers. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,Naltrexone significantly reduced craving for alcohol during alcohol administration in this group of heavy drinking smokers.,"['heavy drinking smokers', 'Heavy drinking smokers of East Asian descent', 'East Asian individuals who have been suggested to differ in response to alcohol and to']","['alcohol', 'naltrexone', 'Naltrexone', 'placebo']","['breath alcohol concentration (BrAC', 'cigarette craving and alcohol craving', 'cigarette craving', 'Craving for cigarettes and alcohol', 'craving for alcohol']","[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0277982', 'cui_str': 'Smell of alcohol on breath (finding)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]",,0.0141006,Naltrexone significantly reduced craving for alcohol during alcohol administration in this group of heavy drinking smokers.,"[{'ForeName': 'ReJoyce', 'Initials': 'R', 'LastName': 'Green', 'Affiliation': 'Department of Psychology, University of California, Los Angeles.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Bujarski', 'Affiliation': 'Department of Psychology, University of California, Los Angeles.'}, {'ForeName': 'Aaron C', 'Initials': 'AC', 'LastName': 'Lim', 'Affiliation': 'Department of Psychology, University of California, Los Angeles.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Venegas', 'Affiliation': 'Department of Psychology, University of California, Los Angeles.'}, {'ForeName': 'Lara A', 'Initials': 'LA', 'LastName': 'Ray', 'Affiliation': 'Department of Psychology, University of California, Los Angeles.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000252']
290,32323144,Cost-utility analysis of factor VIII diet therapies prepared using blood plasma vs. recombinant technique for patients with hemophilia A.,"BACKGROUND


Hemophilia is known as one of the most common coagulation disorders whose treatment costs are particularly high in developing countries, and about 90% of them are related to factor VIII (FVIII) and direct medical costs (DMCs). Thus, the present study aimed to analyze cost-utility of two FVIII diet therapies prepared using blood plasma and recombinant technique.
METHODS


This study was an economic evaluation fulfilled through a cost-utility approach. To this end, a total number of 120 patients were randomly selected using Krejcie & Morgan's Table and then received blood plasma and recombinant FVIII. The decision tree structure was also utilized to estimate economic and clinical outcomes. Moreover, costs were reviewed from societal perspective. Quality-adjusted life year (QALY) was subsequently determined as the measure of effectiveness (MOE). Besides, one-way (univariate) sensitivity analysis was performed to quantify uncertainty effects of the study parameters. The information was ultimately analyzed using the TreeAge Pro 2011 and the Microsoft Office Excel 2010 software.
RESULTS


The results revealed that the recombinant diet therapy had higher costs and effectiveness compared with blood-plasma-derived FVIII, so that the mean costs of these two diet therapies were equal to 37,624 and 20,349 purchasing power parity (PPP) $ with utility scores of 0.78 and 0.62; respectively. Since the incremental cost-effectiveness ratio (ICER) for the recombinant medications was over three times of the threshold level, it was considered as overwhelming because of its high cost in spite of its better effectiveness. Moreover, the results of one-way (univariate) sensitivity analysis demonstrated the highest sensitivity to the utility in patients who had been injected with blood-plasma-derived FVIII and had been successfully treated.
CONCLUSION


The study results revealed that FVIII prepared using blood plasma for hemophilia A patients had higher cost-effectiveness compared with that made using recombinant technique. Graphical abstract.",2020,"The results revealed that the recombinant diet therapy had higher costs and effectiveness compared with blood-plasma-derived FVIII, so that the mean costs of these two diet therapies were equal to 37,624 and 20,349 purchasing power parity (PPP) $ with utility scores of 0.78 and 0.62; respectively.","['120 patients', 'patients with hemophilia A']",['recombinant diet therapy'],"['cost-effectiveness', 'incremental cost-effectiveness ratio (ICER', 'Quality-adjusted life year (QALY', 'effectiveness (MOE', 'costs and effectiveness']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}]","[{'cui': 'C0012160', 'cui_str': 'nutritional management'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.0176148,"The results revealed that the recombinant diet therapy had higher costs and effectiveness compared with blood-plasma-derived FVIII, so that the mean costs of these two diet therapies were equal to 37,624 and 20,349 purchasing power parity (PPP) $ with utility scores of 0.78 and 0.62; respectively.","[{'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Lotfi', 'Affiliation': 'Health Human Resources Research Center, School of Management and Medical Informatics, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Talebianpour', 'Affiliation': 'Department of health management and health economics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Khosro', 'Initials': 'K', 'LastName': 'Keshavarz', 'Affiliation': 'Health Human Resources Research Center, School of Management and Medical Informatics, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Emadi', 'Affiliation': 'School of pharmacy and Medical Sciences, University of South Australia , Adelaide, SA, Australia.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Bordbar', 'Affiliation': 'Medical School, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Peivand', 'Initials': 'P', 'LastName': 'Bastani', 'Affiliation': 'Health Human Resources Research Center, School of Management and Medical Informatics, Shiraz University of Medical Sciences, Shiraz, Iran. bastanip@sums.ac.ir.'}]","Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences",['10.1007/s40199-020-00347-8']
291,32034074,Results of the ADAPT Phase 3 Study of Rocapuldencel-T in Combination with Sunitinib as First-Line Therapy in Patients with Metastatic Renal Cell Carcinoma.,"PURPOSE


Rocapuldencel-T is an autologous immunotherapy prepared from mature monocyte-derived dendritic cells (DC), coelectroporated with amplified tumor RNA plus CD40L RNA. This pivotal phase III trial was initiated to investigate the safety and efficacy of a combination therapy dosing regimen of Rocapuldencel-T plus sunitinib in patients with metastatic renal cell carcinoma (mRCC).
PATIENTS AND METHODS


Patients received either Rocapuldencel-T plus standard of care (SOC) or SOC treatment alone. The primary objective compared overall survival (OS) between groups. Secondary objectives included safety assessments, progression-free survival (PFS), and tumor responses based on RECIST 1.1 criteria. Exploratory analyses included immunologic assessments and correlates with OS.
RESULTS


Between 2013 and 2016, 462 patients were randomized 2:1, 307 to the combination group and 155 to the SOC group. Median OS in the combination group was 27.7 months [95% confidence interval (CI) 23.0-35.9] and 32.4 months (95% CI, 22.5-) in the SOC group HR of 1.10 (95% CI, 0.83-1.40). PFS was 6.0 months and 7.83 months for the combination and SOC groups, respectively [HR = 1.15 (95% CI, 0.92-1.44)]. The ORR was 42.7% (95% CI, 37.1-48.4) for the combination group and 39.4% (95% CI, 31.6-47.5) for the SOC group. Median follow up was 29 months (0.4-47.7 months). On the basis of the lack of clinical efficacy, the ADAPT trial was terminated on February 17, 2017. Immune responses were detected in 70% of patients treated with Rocapuldencel-T, and the magnitude of the immune response positively correlated with OS. In addition, we report the survival-predictive value of measuring IL-12 produced by the DC vaccine and the observation that high baseline numbers of T regulatory cells are associated with improved outcomes in DC-treated patients, but are associated with poor outcomes in patients receiving SOC treatment. No serious adverse events attributed to the study medication have been reported to date.
CONCLUSIONS


Rocapuldencel-T did not improve OS in patients treated with combination therapy, although the induced immune response correlated with OS. Moreover, we identified two potential survival-predictive biomarkers for patients receiving DC based immunotherapy, IL-12 produced by the DC vaccine and higher numbers of T regulatory cells present in the peripheral blood of patients with advanced RCC.",2020,"Rocapuldencel-T did not improve OS in patients treated with combination therapy, although the immune response correlated with OS.","['patients with mRCC', '462 patients were randomized 2:1, 307 to the combination group and 155 to the SOC group', 'patients with metastatic renal cell carcinoma']","['Rocapuldencel-T plus SOC or SOC treatment alone', 'sunitinib', 'Rocapuldencel-T plus sunitinib']","['PFS', 'Immune responses', 'survival-predictive value of IL-12', 'safety and efficacy', 'Median OS', 'ORR', 'safety, PFS and tumor responses', 'immunological assessments and correlates with OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",462.0,0.143527,"Rocapuldencel-T did not improve OS in patients treated with combination therapy, although the immune response correlated with OS.","[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Figlin', 'Affiliation': 'Cedars-Sinai Medical Center Los Angeles, California.'}, {'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'University of Texas, MD Anderson Cancer Center Houston, Texas.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Uzzo', 'Affiliation': 'Fox Chase Cancer Center, Temple University Health System, Philadelphia, Pennsylvania.'}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Tykodi', 'Affiliation': 'Fred Hutchinson Cancer Research Center, University of Washington, Seattle, Washington.'}, {'ForeName': 'David Y T', 'Initials': 'DYT', 'LastName': 'Chen', 'Affiliation': 'Fox Chase Cancer Center, Temple University Health System, Philadelphia, Pennsylvania.'}, {'ForeName': 'Viraj', 'Initials': 'V', 'LastName': 'Master', 'Affiliation': 'Emory University Department of Urology, Emory University Hospital, Atlanta, Georgia.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Kapoor', 'Affiliation': 'Urologic Cancer Centre for Research and Innovation, Hamilton, Ontario, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vaena', 'Affiliation': 'Holden Comprehensive Cancer Center, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Lowrance', 'Affiliation': 'Huntsman Cancer Hospital, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Gennady', 'Initials': 'G', 'LastName': 'Bratslavsky', 'Affiliation': 'SUNY Upstate Medical University, Syracuse, New York.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'DeBenedette', 'Affiliation': 'Argos Therapeutics Inc., now CoImmune Inc., Durham, North Carolina. mdebenedette@coimmune.com.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Gamble', 'Affiliation': 'Argos Therapeutics Inc., now CoImmune Inc., Durham, North Carolina.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Plachco', 'Affiliation': 'Argos Therapeutics Inc., now CoImmune Inc., Durham, North Carolina.'}, {'ForeName': 'Marcus S', 'Initials': 'MS', 'LastName': 'Norris', 'Affiliation': 'Argos Therapeutics Inc., now CoImmune Inc., Durham, North Carolina.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Horvatinovich', 'Affiliation': 'Argos Therapeutics Inc., now CoImmune Inc., Durham, North Carolina.'}, {'ForeName': 'Irina Y', 'Initials': 'IY', 'LastName': 'Tcherepanova', 'Affiliation': 'Argos Therapeutics Inc., now CoImmune Inc., Durham, North Carolina.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nicolette', 'Affiliation': 'Argos Therapeutics Inc., now CoImmune Inc., Durham, North Carolina.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Wood', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-2427']
292,32059021,Evaluating the cost-consequence of a standardized strategy for the etiological diagnosis of uveitis (ULISSE study).,"MAIN OBJECTIVE


To prospectively assess the cost-consequence of a standardized diagnostic strategy as to compared to an open one for the etiological diagnosis of uveitis.
DESIGN


This was a prospective, non-inferiority, multicentre, randomized controlled trial.
METHODS


We included all consecutive patients with uveitis who had visited at least one of the Departments of Ophthalmology. In the standardized group, patients had a minimal work-up regardless of the type of uveitis (including evaluation of the CBC, ESR, C-reactive protein, tuberculin skin test, syphilis serology and chest X-ray). Depending on ophthalmological findings, further investigations could be performed. In the open strategy, ophthalmologists were free to order any kind of investigation. The main outcome was the mean cost per patient of each strategy.
RESULTS


903 uveitis patients were included from January, 2010 to May, 2013. The mean cost per patient of the standardized strategy was 182.97 euros [CI 95% (173.14; 192.80)], and the mean cost per patient of the open strategy was 251.75 euros [CI 95% (229.24; 274.25)]. Therefore, the mean cost per patient of the standardized strategy was significantly lower than the mean cost per patient of the open strategy (p<0.001). There were significantly fewer visits (p<0.001), fewer radiological procedures (p<0.004) and fewer laboratory investigations (p<0.001) in the standardized group.
CONCLUSION


A standardized strategy is a cost-saving approach for the etiological diagnosis of uveitis.",2020,"There were significantly fewer visits (p<0.001), fewer radiological procedures (p<0.004) and fewer laboratory investigations (p<0.001) in the standardized group.
","['903 uveitis patients were included from January, 2010 to May, 2013', 'consecutive patients with uveitis who had visited at least one of the Departments of Ophthalmology']",[],"['mean cost per patient of the standardized strategy', 'mean cost per patient of each strategy']","[{'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",903.0,0.109393,"There were significantly fewer visits (p<0.001), fewer radiological procedures (p<0.004) and fewer laboratory investigations (p<0.001) in the standardized group.
","[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'de Parisot', 'Affiliation': 'Department of Internal Medicine, Hospices Civils de Lyon, Croix-Rousse Hospital, Lyon, France.'}, {'ForeName': 'Yvan', 'Initials': 'Y', 'LastName': 'Jamilloux', 'Affiliation': 'Department of Internal Medicine, Hospices Civils de Lyon, Croix-Rousse Hospital, Lyon, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Kodjikian', 'Affiliation': 'Department of Ophthalmology, Hospices Civils de Lyon, Croix-Rousse Hospital, Lyon, France.'}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Errera', 'Affiliation': 'Department of Ophthalmology, Quinze-Vingts Hospital, Paris, France.'}, {'ForeName': 'Neila', 'Initials': 'N', 'LastName': 'Sedira', 'Affiliation': 'Department of Internal Medicine, Quinze-Vingts Hospital, Paris, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Heron', 'Affiliation': 'Department of Internal Medicine, Quinze-Vingts Hospital, Paris, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Pérard', 'Affiliation': 'Department of Internal Medicine, Edouard-Herriot Hospital, Lyon, France.'}, {'ForeName': 'Pierre-Loïc', 'Initials': 'PL', 'LastName': 'Cornut', 'Affiliation': 'Department of Ophthalmology, Edouard-Herriot Hospital, Lyon, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Schneider', 'Affiliation': 'Department of Ophthalmology, Centre Hospitalier Regional Universitaire de Montpellier, Montpellier, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Rivière', 'Affiliation': 'Department of Internal Medicine, Centre Hospitalier Regional Universitaire de Montpellier, Montpellier, France.'}, {'ForeName': 'Priscille', 'Initials': 'P', 'LastName': 'Ollé', 'Affiliation': 'Department of Ophthalmology, Pierre-Paul Riquet Hospital, Toulouse, France.'}, {'ForeName': 'Grégory', 'Initials': 'G', 'LastName': 'Pugnet', 'Affiliation': 'Department of Internal Medicine, Purpan University Hospital, Toulouse, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Cathébras', 'Affiliation': 'Department of Internal Medicine, Centre Hospitalier Universitaire de Saint-Etienne, Saint-Étienne, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Manoli', 'Affiliation': 'Department of Ophthalmology, Centre Hospitalier Universitaire de Saint-Etienne, Saint-Étienne, France.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Bodaghi', 'Affiliation': 'Department of Ophthalmology, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Saadoun', 'Affiliation': 'Department of Internal Medicine, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Baillif', 'Affiliation': 'Department of Ophthalmology, Centre Hospitalier Universitaire de Nice, Nice, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Tieulie', 'Affiliation': 'Department of Internal Medicine, Centre Hospitalier Universitaire de Nice, Nice, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'André', 'Affiliation': 'Department of Internal Medicine, Gabriel-Montpied Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Chiambaretta', 'Affiliation': 'Department of Ophthalmology, Gabriel-Montpied Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bonin', 'Affiliation': 'Department of Ophthalmology, Gabriel-Montpied Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Bielefeld', 'Affiliation': 'Department of Internal Medicine, Centre Hospitalier Universitaire de Dijon, Dijon, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Bron', 'Affiliation': 'Department of Ophthalmology, Centre Hospitalier Universitaire de Dijon, Dijon, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Mouriaux', 'Affiliation': 'Department of Ophthalmology, Centre Hospitalier Universitaire de Caen, Caen, France.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Bienvenu', 'Affiliation': 'Department of Internal Medicine, Centre Hospitalier Universitaire de Caen, Caen, France.'}, {'ForeName': 'Nassira', 'Initials': 'N', 'LastName': 'Amamra', 'Affiliation': 'Pole IMER, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Guerre', 'Affiliation': 'Pole IMER, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Decullier', 'Affiliation': 'Pole IMER, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Sève', 'Affiliation': 'Department of Internal Medicine, Hospices Civils de Lyon, Croix-Rousse Hospital, Lyon, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0228918']
293,31802732,Clinical Outcome of Febrile Tanzanian Children with Severe Malnutrition Using Anthropometry in Comparison to Clinical Signs.,"Children with malnutrition compared with those without are at higher risk of infection, with more severe outcomes. How clinicians assess nutritional risk factors in febrile children in primary care varies. We conducted a post hoc subgroup analysis of febrile children with severe malnutrition enrolled in a randomized, controlled trial in primary care centers in Tanzania. The clinical outcome of children with severe malnutrition defined by anthropometric measures and clinical signs was compared between two electronic clinical diagnostic algorithms: ePOCT, which uses weight-for-age and mid-upper arm circumference to identify and manage severe malnutrition, and ALMANACH, which uses the clinical signs of edema of both feet and visible severe wasting. Those identified as having severe malnutrition by the algorithms in each arm were prescribed antibiotics and referred to the hospital. From December 2014 to February 2016, 106 febrile children were enrolled and randomized in the parent study, and met the criteria to be included in the present analysis. ePOCT identified 56/57 children with severe malnutrition using anthropometric measures, whereas ALMANACH identified 2/49 children with severe malnutrition using clinical signs. The proportion of clinical failure, defined as the development of severe symptoms by day 7 or persisting symptoms at day 7 (per-protocol), was 1.8% (1/56) in the ePOCT arm versus 16.7% (8/48) in the Algorithm for the MANagement of Childhood illnesses arm (risk difference -14.9%, 95% CI -26.0%, -3.8%; risk ratio 0.11, 95% CI 0.01, 0.83). Using anthropometric measures to identify and manage febrile children with severe malnutrition may have resulted in better clinical outcomes than by using clinical signs alone.",2020,"The clinical outcome of children with severe malnutrition defined by anthropometric measures and clinical signs was compared between two electronic clinical diagnostic algorithms: ePOCT, which uses weight-for-age and mid-upper arm circumference to identify and manage severe malnutrition, and ALMANACH, which uses the clinical signs of edema of both feet and visible severe wasting.","['From December 2014 to February 2016, 106 febrile children', 'Children with malnutrition', 'febrile children with severe malnutrition', 'children with severe malnutrition', 'febrile children with severe malnutrition enrolled in a randomized, controlled trial in primary care centers in Tanzania', 'febrile children in primary care varies', 'Febrile Tanzanian Children with Severe Malnutrition Using Anthropometry in Comparison to Clinical Signs', '56/57 children with severe malnutrition using anthropometric measures, whereas ALMANACH identified 2/49 children with severe malnutrition using clinical signs']",[],['proportion of clinical failure'],"[{'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0311276', 'cui_str': 'Severe malnutrition'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}]",[],"[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",106.0,0.10664,"The clinical outcome of children with severe malnutrition defined by anthropometric measures and clinical signs was compared between two electronic clinical diagnostic algorithms: ePOCT, which uses weight-for-age and mid-upper arm circumference to identify and manage severe malnutrition, and ALMANACH, which uses the clinical signs of edema of both feet and visible severe wasting.","[{'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Tan', 'Affiliation': 'Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kagoro', 'Affiliation': 'Ifakara Health Institute, Dar es Salaam, Tanzania.'}, {'ForeName': 'Gillian A', 'Initials': 'GA', 'LastName': 'Levine', 'Affiliation': 'Swiss Tropical and Public Health Institute (SwissTPH), University of Basel, Switzerland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Masimba', 'Affiliation': 'Ifakara Health Institute, Dar es Salaam, Tanzania.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Samaka', 'Affiliation': 'Amana Hospital, Dar es Salaam, Tanzania.'}, {'ForeName': 'Willy', 'Initials': 'W', 'LastName': 'Sangu', 'Affiliation': 'Dar es Salaam City Council, Dar es Salaam, Tanzania.'}, {'ForeName': 'Blaise', 'Initials': 'B', 'LastName': 'Genton', 'Affiliation': 'Swiss Tropical and Public Health Institute (SwissTPH), University of Basel, Switzerland.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': ""D'Acremont"", 'Affiliation': 'Swiss Tropical and Public Health Institute (SwissTPH), University of Basel, Switzerland.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Keitel', 'Affiliation': 'Department of Pediatric Emergency Medicine, University Hospital Bern, Bern, Switzerland.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0553']
294,32251031,Intrathecal Morphine versus Intrathecal Hydromorphone for Analgesia after Cesarean Delivery: A Randomized Clinical Trial.,"BACKGROUND


Intrathecal opioids are routinely administered during spinal anesthesia for postcesarean analgesia. The effectiveness of intrathecal morphine for postcesarean analgesia is well established, and the use of intrathecal hydromorphone is growing. No prospective studies have compared the effectiveness of equipotent doses of intrathecal morphine versus intrathecal hydromorphone as part of a multimodal analgesic regimen for postcesarean analgesia. The authors hypothesized that intrathecal morphine would result in superior analgesia compared with intrathecal hydromorphone 24 h after delivery.
METHODS


In this single-center, double-blinded, randomized trial, 138 parturients undergoing scheduled cesarean delivery were randomized to receive 150 µg of intrathecal morphine or 75 µg of intrathecal hydromorphone as part of a primary spinal anesthetic and multimodal analgesic regimen; 134 parturients were included in the analysis. The primary outcome was the numerical rating scale score for pain with movement 24 h after delivery. Static and dynamic pain scores, nausea, pruritus, degree of sedation, and patient satisfaction were assessed every 6 h for 36 h postpartum. Total opioid consumption was recorded.
RESULTS


There was no significant difference in pain scores with movement at 24 h (intrathecal hydromorphone median [25th, 75th] 4 [3, 5] and intrathecal morphine 3 [2, 4.5]) or at any time point (estimated difference, 0.5; 95% CI, 0 to 1; P = 0.139). Opioid received in the first 24 h did not differ between groups (median [25th, 75th] oral morphine milligram equivalents for intrathecal hydromorphone 30 [7.5, 45.06] vs. intrathecal morphine 22.5 [14.0, 37.5], P = 0.769). From Kaplan-Meier analysis, the median time to first opioid request was 5.4 h for hydromorphone and 12.1 h for morphine (log-rank test P = 0.200).
CONCLUSIONS


Although the hypothesis was that intrathecal morphine would provide superior analgesia to intrathecal hydromorphone, the results did not confirm this. At the doses studied, both intrathecal morphine and intrathecal hydromorphone provide effective postcesarean analgesia when combined with a multimodal analgesia regimen.",2020,"There was no significant difference in pain scores with movement at 24 h (intrathecal hydromorphone median [25th, 75th] 4 [3, 5] and intrathecal morphine 3 [2, 4.5]) or at any time point (estimated difference, 0.5; 95% CI, 0 to 1; P = 0.139).","['Analgesia after Cesarean Delivery', '134 parturients were included in the analysis', 'women receiving cesarean delivery using pain score at 24 h as the primary outcome', '138 parturients undergoing scheduled cesarean delivery', 'postcesarean analgesia']","['intrathecal hydromorphone as part of a primary spinal anesthetic and multimodal analgesic regimen', 'Intrathecal Morphine', 'Intrathecal Hydromorphone', 'hydromorphone', 'intrathecal hydromorphone', 'morphine', 'Intrathecal opioids', 'intrathecal morphine and intrathecal hydromorphone', 'intrathecal hydromorphone and intrathecal morphine', 'intrathecal morphine']","['median time to first opioid request', 'Static and dynamic pain scores, nausea, pruritus, degree of sedation, and patient satisfaction', 'numerical rating scale score for pain with movement 24 h after delivery', 'breakthrough analgesic requirements', 'superior analgesia', 'pain scores', 'Total opioid consumption']","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",138.0,0.536156,"There was no significant difference in pain scores with movement at 24 h (intrathecal hydromorphone median [25th, 75th] 4 [3, 5] and intrathecal morphine 3 [2, 4.5]) or at any time point (estimated difference, 0.5; 95% CI, 0 to 1; P = 0.139).","[{'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Sharpe', 'Affiliation': 'From the Departments of Anesthesiology and Peri-operative Medicine (E.E.S., R.J.M., K.W.A., D.A.O., R.L.J., A.K.J., A.D.N., H.P.S.) Obstetrics and Gynecology (V.E.T.) Health Sciences Research (D.R.S.), Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Rochelle J', 'Initials': 'RJ', 'LastName': 'Molitor', 'Affiliation': ''}, {'ForeName': 'Katherine W', 'Initials': 'KW', 'LastName': 'Arendt', 'Affiliation': ''}, {'ForeName': 'Vanessa E', 'Initials': 'VE', 'LastName': 'Torbenson', 'Affiliation': ''}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Olsen', 'Affiliation': ''}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Darrell R', 'Initials': 'DR', 'LastName': 'Schroeder', 'Affiliation': ''}, {'ForeName': 'Adam K', 'Initials': 'AK', 'LastName': 'Jacob', 'Affiliation': ''}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Niesen', 'Affiliation': ''}, {'ForeName': 'Hans P', 'Initials': 'HP', 'LastName': 'Sviggum', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003283']
295,31538372,Differential Posttreatment Outcomes of Methylphenidate for Smoking Cessation for Individuals With ADHD.,"BACKGROUND AND OBJECTIVES


In a multisite, randomized study (CTN-0029), a 3-month course of Osmotic-Release Oral System Methylphenidate (OROS-MPH) improved smoking cessation in a group of patients with higher baseline severity in Attention-Deficit/Hyperactivity Disorder (ADHD). This treatment, however, worsened smoking cessation outcome in the group with lower baseline ADHD severity. We want to examine whether this differential treatment effect persisted after OROS-MPH was discontinued.
METHODS


We conducted a secondary analysis of the 1-month follow-up data from CTN-0029 after the discontinuation of OROS-MPH (N = 134). Nicotine patch was tapered during this month. We tested whether OROS-MPH had an effect on self-reported 7-day abstinence by week, as well as possible treatment by baseline ADHD severity interactions.
RESULTS


Abstinence diminished overall in time after the end of the treatment. In the high baseline severity group, patients who received OROS-MPH had an advantage in 7-day abstinence at week 15 (40% for OROS-MPH vs 20% for placebo, odds ratio = 2.63, P = .028). In the lower severity group (n = 121), no difference was detected (29% for OROS-MPH vs 32% for placebo, P = 1.00) between the two treatment groups. There was also a significant treatment by baseline ADHD severity interaction (P = .03).
CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE


OROS-MPH promotes abstinence beyond the course of treatment for patients with more severe ADHD, while the paradoxical effects in the lower baseline severity group is not persistent after medication discontinuation. Targeting ADHD in smoking cessation as a comorbidity therefore can have broader impact with more precise patient selection. (Am J Addict).",2019,"In the lower severity group (n = 121), no difference was detected (29% for OROS-MPH vs 32% for placebo, P = 1.00) between the two treatment groups.","['patients with more severe ADHD', 'patients with higher baseline severity in Attention-Deficit/Hyperactivity Disorder (ADHD', 'Individuals With ADHD']","['OROS-MPH', 'Osmotic-Release Oral System Methylphenidate (OROS-MPH', 'Nicotine patch', 'Methylphenidate']","['7-day abstinence', 'baseline ADHD severity interaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",,0.240385,"In the lower severity group (n = 121), no difference was detected (29% for OROS-MPH vs 32% for placebo, P = 1.00) between the two treatment groups.","[{'ForeName': 'Sean X', 'Initials': 'SX', 'LastName': 'Luo', 'Affiliation': 'Department of Psychiatry, Division on Substance Use Disorders, Columbia University, New York, New York.'}, {'ForeName': 'Lirio S', 'Initials': 'LS', 'LastName': 'Covey', 'Affiliation': 'Department of Psychiatry, Division on Substance Use Disorders, Columbia University, New York, New York.'}, {'ForeName': 'Mei-Chen', 'Initials': 'MC', 'LastName': 'Hu', 'Affiliation': 'Department of Psychiatry, Division on Substance Use Disorders, Columbia University, New York, New York.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Winhusen', 'Affiliation': 'Division of Addiction Sciences, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'Department of Psychiatry, Division on Substance Use Disorders, Columbia University, New York, New York.'}]",The American journal on addictions,['10.1111/ajad.12961']
296,31794974,One-year clinical outcomes following theta burst stimulation for post-traumatic stress disorder.,"Theta burst transcranial magnetic stimulation (TBS) is a potential new treatment for post-traumatic stress disorder (PTSD). We previously reported active intermittent TBS (iTBS) was associated with superior clinical outcomes for up to 1-month, in a sample of fifty veterans with PTSD, using a crossover design. In that study, participants randomized to the active group received a total of 4-weeks of active iTBS, or 2-weeks if randomized to sham. Results were superior with greater exposure to active iTBS, which raised the question of whether observed effects persisted over the longer-term. This study reviewed naturalistic outcomes up to 1-year from study endpoint, to test the hypothesis that greater exposure to active iTBS would be associated with superior outcomes. The primary outcome measure was clinical relapse, defined as any serious adverse event (e.g., suicide, psychiatric hospitalization, etc.,) or need for retreatment with repetitive transcranial magnetic stimulation (rTMS). Forty-six (92%) of the initial study's intent-to-treat participants were included. Mean age was 51.0 ± 12.3 years and seven (15.2%) were female. The group originally randomized to active iTBS (4-weeks active iTBS) demonstrated superior outcomes at one year compared to those originally randomized to sham (2-weeks active iTBS); log-rank ChiSq = 5.871, df = 1, p = 0.015; OR = 3.50, 95% CI = 1.04-11.79. Mean days to relapse were 296.0 ± 22.1 in the 4-week group, and 182.0 ± 31.9 in the 2-week group. When used, rTMS retreatment was generally effective. Exploratory neuroimaging revealed default mode network connectivity was predictive of 1-year outcomes (corrected p < 0.05). In summary, greater accumulated exposure to active iTBS demonstrated clinically meaningful improvements in the year following stimulation, and default mode connectivity could be used to predict longer-term outcomes.",2020,"The group originally randomized to active iTBS (4-weeks active iTBS) demonstrated superior outcomes at one year compared to those originally randomized to sham (2-weeks active iTBS); log-rank ChiSq = 5.871, df = 1, p = 0.015; OR = 3.50, 95% CI = 1.04-11.79.","['post-traumatic stress disorder (PTSD', 'Mean age was 51.0\u2009±\u200912.3 years and seven (15.2%) were female', 'fifty veterans with PTSD', ""Forty-six (92%) of the initial study's intent-to-treat participants were included""]","['total of 4-weeks of active iTBS', 'active iTBS (4-weeks active iTBS', 'theta burst stimulation', 'active intermittent TBS (iTBS', 'Theta burst transcranial magnetic stimulation (TBS', 'TMS']","['clinical relapse, defined as any serious adverse event (e.g., suicide, psychiatric hospitalization, etc.,) or need for retreatment with repetitive transcranial magnetic stimulation (rTMS', 'Mean days to relapse']","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",50.0,0.149203,"The group originally randomized to active iTBS (4-weeks active iTBS) demonstrated superior outcomes at one year compared to those originally randomized to sham (2-weeks active iTBS); log-rank ChiSq = 5.871, df = 1, p = 0.015; OR = 3.50, 95% CI = 1.04-11.79.","[{'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Petrosino', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': ""Mascha van 't"", 'Initials': ""MV'"", 'LastName': 'Wout-Frank', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Aiken', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Swearingen', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Barredo', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Zandvakili', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Noah S', 'Initials': 'NS', 'LastName': 'Philip', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA. noah_philip@brown.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0584-4']
297,31995812,Evaluating global brain connectivity as an imaging marker for depression: influence of preprocessing strategies and placebo-controlled ketamine treatment.,"Major depressive disorder (MDD) is associated with altered global brain connectivity (GBC), as assessed via resting-state functional magnetic resonance imaging (rsfMRI). Previous studies found that antidepressant treatment with ketamine normalized aberrant GBC changes in the prefrontal and cingulate cortices, warranting further investigations of GBC as a putative imaging marker. These results were obtained via global signal regression (GSR). This study is an independent replication of that analysis using a separate dataset. GBC was analyzed in 28 individuals with MDD and 22 healthy controls (HCs) at baseline, post-placebo, and post-ketamine. To investigate the effects of preprocessing, three distinct pipelines were used: (1) regression of white matter (WM)/cerebrospinal fluid (CSF) signals only (BASE); (2) WM/CSF + GSR (GSR); and (3) WM/CSF + physiological parameter regression (PHYSIO). Reduced GBC was observed in individuals with MDD only at baseline in the anterior and medial cingulate cortices, as well as in the prefrontal cortex only after regressing the global signal. Ketamine had no effect compared to baseline or placebo in either group in any pipeline. PHYSIO did not resemble GBC preprocessed with GSR. These results concur with several studies that used GSR to study GBC. Further investigations are warranted into disease-specific components of global fMRI signals that may drive these results and of GBCr as a potential imaging marker in MDD.",2020,"Reduced GBC was observed in individuals with MDD only at baseline in the anterior and medial cingulate cortices, as well as in the prefrontal cortex only after regressing the global signal.","['Major depressive disorder (MDD', '28 individuals with MDD and 22 healthy controls (HCs) at baseline, post']","['placebo', 'Ketamine', 'placebo-controlled ketamine', 'ketamine', 'white matter (WM)/cerebrospinal fluid (CSF) signals only (BASE); (2) WM/CSF\u2009+\u2009GSR (GSR); and (3) WM/CSF\u2009+\u2009physiological parameter regression (PHYSIO']","['GBC', 'Reduced GBC']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0682708'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0684321', 'cui_str': 'Regression'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",28.0,0.0521611,"Reduced GBC was observed in individuals with MDD only at baseline in the anterior and medial cingulate cortices, as well as in the prefrontal cortex only after regressing the global signal.","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kraus', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. christoph.kraus@nih.gov.'}, {'ForeName': 'Anahit', 'Initials': 'A', 'LastName': 'Mkrtchian', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bashkim', 'Initials': 'B', 'LastName': 'Kadriu', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Evans', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0624-0']
298,31995813,"Modafinil enhances cognitive, but not emotional conflict processing via enhanced inferior frontal gyrus activation and its communication with the dorsomedial prefrontal cortex.","Cognitive control regulates cognitive and emotional systems to facilitate goal-directed behavior in the context of task-irrelevant distractors. Cognitive control deficits contribute to residual functional impairments across psychiatric disorders and represent a promising novel treatment target. Translational evidence suggests that modafinil may enhance performance in executive functions; however, differential effects on regulatory control in cognitive and emotional domains have not been examined. The present pre-registered randomized-controlled pharmacological fMRI trial examined differential effects of modafinil (single-dose, 200 mg) on cognitive and emotional conflict processing. To further separate objective cognitive enhancing effects from subjective performance perception, a metacognitive paradigm was employed. Results indicated that modafinil specifically enhanced cognitive conflict performance and concomitantly increased activation in the inferior frontal gyrus and its functional communication with the dorsomedial prefrontal cortex. Exploratory analysis further revealed modafinil-enhanced basolateral amygdala reactivity to cognitive conflict, with stronger reactivity being associated with higher cognitive conflict performance. Whereas modafinil enhanced cognitive performance in the metacognitive paradigm, confidence indices remained unaffected. Overall, the present results suggest that modafinil has the potential to enhance cognitive conflict processing while leaving emotional conflict processing unaffected. On the neural level modafinil enhanced the recruitment of a network engaged in general conflict and regulatory control processes, whereas effects on the amygdala may reflect improved arousal-mediated attention processes for conflicting information. The pattern of cognitive enhancing effects in the absence of effects on affective processing suggests a promising potential to enhance cognitive control in clinical populations.",2020,"On the neural level modafinil enhanced the recruitment of a network engaged in general conflict and regulatory control processes, whereas effects on the amygdala may reflect improved arousal-mediated attention processes for conflicting information.",[],"['Modafinil', 'modafinil']","['cognitive performance', 'cognitive and emotional conflict processing', 'cognitive conflict performance']",[],"[{'cui': 'C0066677', 'cui_str': 'modafinil'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}]",,0.0288783,"On the neural level modafinil enhanced the recruitment of a network engaged in general conflict and regulatory control processes, whereas effects on the amygdala may reflect improved arousal-mediated attention processes for conflicting information.","[{'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Congcong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xin', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Daumann', 'Affiliation': 'LVR Clinics of Cologne, Cologne, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Daumann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Kendrick', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China. ben_becker@gmx.de.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0625-z']
299,32320457,Sexual network distribution of HIV self-testing kits: Findings from the process evaluation of an intervention for men who have sex with men in China.,"BACKGROUND


The World Health Organization has recommended HIV self-testing (HIVST) as an alternative testing strategy given the limitations of facility-based testing. While the benefits of HIV self-testing have been demonstrated at the individual level among men who have sex with men (MSM), limited data exist on if this testing approach can be effectively diffused through individuals' social or sexual networks. The objectives of this study were to examine patterns and correlates of HIVST distribution within Chinese MSM's sexual networks.
METHODS


Data used for this analysis was a part of the process evaluation of an HIVST intervention trial among MSM in Nanjing, China. Between May and October 2017, we enrolled 400 men into the trial. Participants assigned to the intervention group (N = 200) were given three HIVST kits at baseline and could request more during the follow-up periods. We incorporated measures for process evaluation in the self-administered online follow-up surveys. This analysis reported findings from the three-month follow-up survey in the intervention group. Frequencies and percentages were used to describe characteristics of participants who distributed kits to their sexual partners as well as patterns of distribution. Multivariable logistic regression was conducted to identify independent correlates of participants who distributed the kits.
RESULTS


Of the 177 participants retained (88.5%) at the three-month follow-up, 72 (40.7%) distributed one or more kits to either primary or casual partners. About half of distributors (51.4%) gave one HIVST kit to their sexual partners while 15.3% distributed 3 or more. Over half gave these kits (58.3%) to primary sexual partners while 27.8% reported giving the kits to both primary and casual partners. About half (54.2%) of distributors used the kits together with their partners. Compared to participants who had an HIV test in the past six months, those who tested over six months ago or never tested had significantly lower odds of distributing the kits (AOR = 0.484, 95% CI: 0.250-0.983, p = 0.032). Compared to those who had not used the kits themselves, participants who did had significantly higher odds of distributing the kits (AOR = 3.345, 95% CI: 1.488-7.517, p = 0.003). Participants who reported higher HIV testing efficacy had 2.051 fold greater odds (95% CI: 1.062-3.961, p = 0.033) of distributing the kits compared to those who had lower efficacy.
CONCLUSION


Our study demonstrated that a sexual network-based approach to distributing HIVST among Chinese MSM is feasible and can be a promising strategy to improve the effectiveness of HIVST programs including its reach to untested men. Such approach should be complimented by intervention components that enhance HIV testing efficacy and improve experiences of HIVST.",2020,"Participants who reported higher HIV testing efficacy had 2.051 fold greater odds (95% CI: 1.062-3.961, p = 0.033) of distributing the kits compared to those who had lower efficacy.
","['men who have sex with men (MSM', 'men who have sex with men in China', '400 men into the trial', 'Of the 177 participants retained (88.5%) at the three-month follow-up, 72 (40.7%) distributed one or more kits to either primary or casual partners']",['HIV self-testing kits'],['HIV testing efficacy'],"[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}]","[{'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",400.0,0.0417201,"Participants who reported higher HIV testing efficacy had 2.051 fold greater odds (95% CI: 1.062-3.961, p = 0.033) of distributing the kits compared to those who had lower efficacy.
","[{'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': 'Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'Xuzhou Central Hospital, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China.'}, {'ForeName': 'Gengfeng', 'Initials': 'G', 'LastName': 'Fu', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China.'}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Jiangsu Institute of Parasitic Diseases, Wuxi, Jiangsu, China.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Hongjing', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China.'}, {'ForeName': 'Chongyi', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': 'Department of Health Behavior, Society, and Policy, Rutgers School of Public Health, New Jersey, United States of America.'}]",PloS one,['10.1371/journal.pone.0232094']
300,28489506,Prehospital Intubation is Associated with Favorable Outcomes and Lower Mortality in ProTECT III.,"OBJECTIVE


Traumatic brain injury (TBI) causes more than 2.5 million emergency department visits, hospitalizations, or deaths annually. Prehospital endotracheal intubation has been associated with poor outcomes in patients with TBI in several retrospective observational studies. We evaluated the relationship between prehospital intubation, functional outcomes, and mortality using high quality data on clinical practice collected prospectively during a randomized multicenter clinical trial.
METHODS


ProTECT III was a multicenter randomized, double-blind, placebo-controlled trial of early administration of progesterone in 882 patients with acute moderate to severe nonpenetrating TBI. Patients were excluded if they had an index GCS of 3 and nonreactive pupils, those with withdrawal of life support on arrival, and if they had documented prolonged hypotension and/or hypoxia. Prehospital intubation was performed as per local clinical protocol in each participating EMS system. Models for favorable outcome and mortality included prehospital intubation, method of transport, index GCS, age, race, and ethnicity as independent variables. Significance was set at α = 0.05. Favorable outcome was defined by a stratified dichotomy of the GOS-E scores in which the definition of favorable outcome depended on the severity of the initial injury.
RESULTS


Favorable outcome was more frequent in the 349 subjects with prehospital intubation (57.3%) than in the other 533 patients (46.0%, p = 0.003). Mortality was also lower in the prehospital intubation group (13.8% v. 19.5%, p = 0.03). Logistic regression analysis of prehospital intubation and mortality, adjusted for index GCS, showed that odds of dying for those with prehospital intubation were 47% lower than for those that were not intubated (OR = 0.53, 95% CI = 0.36-0.78). 279 patients with prehospital intubation were transported by air. Modeling transport method and mortality, adjusted for index GCS, showed increased odds of dying in those transported by ground compared to those transported by air (OR = 2.10, 95% CI = 1.40-3.15). Decreased odds of dying trended among those with prehospital intubation adjusted for transport method, index GCS score at randomization, age, and race/ethnicity (OR = 0.70, 95% CI = 0.37-1.31).
CONCLUSIONS


In this study that excluded moribund patients, prehospital intubation was performed primarily in patients transported by air. Prehospital intubation and air medical transport together were associated with favorable outcomes and lower mortality. Prehospital intubation was not associated with increased morbidity or mortality regardless of transport method or severity of injury.",2017,"Mortality was also lower in the prehospital intubation group (13.8% v. 19.5%, p = 0.03).","['349 subjects with', 'Patients were excluded if they had an index GCS of 3 and nonreactive pupils, those with withdrawal of life support on arrival, and if they had documented prolonged hypotension and/or hypoxia', 'patients with TBI in several retrospective observational studies', '279 patients with prehospital intubation', '882 patients with acute moderate to severe nonpenetrating TBI']","['progesterone', 'Prehospital endotracheal intubation', 'placebo']","['Mortality', 'prehospital intubation, method of transport, index GCS, age, race, and ethnicity as independent variables', 'severity of the initial injury', 'odds of dying for those with prehospital intubation', 'prehospital intubation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C1963783', 'cui_str': 'Withdrawal of life support'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}]",882.0,0.215675,"Mortality was also lower in the prehospital intubation group (13.8% v. 19.5%, p = 0.03).","[{'ForeName': 'Kurt R', 'Initials': 'KR', 'LastName': 'Denninghoff', 'Affiliation': ''}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Nuño', 'Affiliation': ''}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Pauls', 'Affiliation': ''}, {'ForeName': 'Sharon D', 'Initials': 'SD', 'LastName': 'Yeatts', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Silbergleit', 'Affiliation': ''}, {'ForeName': 'Yuko Y', 'Initials': 'YY', 'LastName': 'Palesch', 'Affiliation': ''}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Merck', 'Affiliation': ''}, {'ForeName': 'Geoff T', 'Initials': 'GT', 'LastName': 'Manley', 'Affiliation': ''}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Wright', 'Affiliation': ''}]",Prehospital emergency care : official journal of the National Association of EMS Physicians and the National Association of State EMS Directors,['10.1080/10903127.2017.1315201']
301,29154553,A randomized trial of female-specific cognitive behavior therapy for alcohol dependent women.,"This study compared Female-Specific Cognitive Behavioral Therapy (FS-CBT) to evidence-based, gender-neutral CBT (GN-CBT; Epstein & McCrady, 2009) for women with alcohol use disorder (AUD). Women (N = 99) with AUD, mean age 48, were randomly assigned to 12 outpatient manual-guided sessions of FS-CBT (n = 44) or GN-CBT (n = 55). Women were assessed at baseline and 3, 9 and 15 months after baseline for drinking and for specific issues common among women with AUD. A FS-CBT protocol was developed that was discriminable on treatment integrity ratings from GN-CBT. No treatment condition differences were found in treatment engagement, changes in drinking, alcohol-related coping, abstinence self-efficacy, motivation to change, or constructs directly targeted in FS-CBT (sociotropy, autonomy, depression, anxiety). Women in both conditions were highly engaged and satisfied with treatment, and reported significant reductions in drinking and changes in desired directions for all other variables except social support for abstinence. In the year following treatment, women in the FS-CBT but not in the CBT condition reported an increase in percentage of abstainers in their social networks (0.69% per month, SE = 0.21, p = .002). The value and appeal of female-specific programming in AUD treatment has been established in the wider literature (Epstein & Menges, 2013), and the current study provides support for the use of the Female-Specific Cognitive Behavioral Therapy (FS-CBT) manual as an option that may yield outcomes similar to standard gender-neutral CBT for women with AUD. Future research should examine whether FS-CBT enhances treatment utilization for women. (PsycINFO Database Record",2018,"No treatment condition differences were found in treatment engagement, changes in drinking, alcohol-related coping, abstinence self-efficacy, motivation to change, or constructs directly targeted in FS-CBT (sociotropy, autonomy, depression, anxiety).","['women', 'Women (N = 99) with AUD, mean age 48', 'women with alcohol use disorder (AUD', 'alcohol dependent women']","['FS-CBT', 'Female-Specific Cognitive Behavioral Therapy (FS-CBT', 'female-specific cognitive behavior therapy', 'GN-CBT']","['percentage of abstainers in their social networks', 'treatment engagement, changes in drinking, alcohol-related coping, abstinence self-efficacy, motivation to change, or constructs directly targeted in FS-CBT (sociotropy, autonomy, depression, anxiety']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}]","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",99.0,0.0370156,"No treatment condition differences were found in treatment engagement, changes in drinking, alcohol-related coping, abstinence self-efficacy, motivation to change, or constructs directly targeted in FS-CBT (sociotropy, autonomy, depression, anxiety).","[{'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Epstein', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey.'}, {'ForeName': 'Barbara S', 'Initials': 'BS', 'LastName': 'McCrady', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Hallgren', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey.'}, {'ForeName': 'Noelle K', 'Initials': 'NK', 'LastName': 'Jensen', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hildebrandt', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000330']
302,30654297,Randomised phase 2 study of pembrolizumab plus CC-486 versus pembrolizumab plus placebo in patients with previously treated advanced non-small cell lung cancer.,"INTRODUCTION


Preclinical and early clinical studies suggest that combining epigenetic agents with checkpoint inhibitors can potentially improve outcomes in patients with previously treated advanced non-small cell lung cancer (NSCLC). This phase 2 trial examined second-line pembrolizumab + CC-486 (oral azacitidine) in patients with advanced NSCLC.
METHODS


Patients with one prior line of platinum-containing therapy were randomised in a ratio of 1:1 to CC-486 or placebo, on days 1-14, in combination with pembrolizumab on day 1 of a 21-day cycle. The primary end-point was progression-free survival (PFS). Key secondary end-points included overall survival (OS), overall response rate (ORR) and safety.
RESULTS


Among 100 patients randomised (pembrolizumab + CC-486: 51; pembrolizumab + placebo: 49), most were male (57.0%), were white (87.0%) and had Eastern Cooperative Oncology Group performance status 1 (68.0%). No significant difference in PFS was observed between the pembrolizumab + CC-486 and pembrolizumab + placebo arms (median, 2.9 and 4.0 months, respectively; hazard ratio [HR], 1.374; 90% confidence interval [CI], 0.926-2.038; P = 0.1789). Median OS was 11.9 months versus not estimable (HR, 1.375; 90% CI, 0.830-2.276; P = 0.2968); ORR was 20% versus 14%. Median treatment duration was shorter (15.0 versus 24.1 weeks), and the number of cycles was lower (5.0 versus 7.0) with pembrolizumab + CC-486 versus pembrolizumab + placebo. No new safety signals for CC-486 or pembrolizumab were detected. Treatment-emergent adverse events were more common in the pembrolizumab + CC-486 arm, particularly gastrointestinal, potentially impacting treatment feasibility.
CONCLUSIONS


No improvement in PFS was observed with pembrolizumab + CC-486 versus pembrolizumab + placebo. Decreased treatment exposure due to adverse events may have impacted efficacy with pembrolizumab + CC-486.",2019,"Median OS was 11.9 months versus not estimable (HR, 1.375; 90% CI, 0.830-2.276; P = 0.2968); ORR was 20% versus 14%.","['Patients with one prior line of platinum-containing therapy', 'patients with previously treated advanced non-small cell lung cancer (NSCLC', '49), most were male (57.0%), were white (87.0%)\xa0and had Eastern Cooperative Oncology Group performance status 1 (68.0', 'patients with advanced NSCLC', 'patients with previously treated advanced non-small cell lung cancer', '100 patients randomised']","['pembrolizumab\xa0+\xa0CC-486: 51; pembrolizumab\xa0+\xa0placebo', 'CC-486 or placebo', 'pembrolizumab\xa0+\xa0CC-486 (oral azacitidine', 'pembrolizumab\xa0+\xa0placebo', 'pembrolizumab plus placebo', 'pembrolizumab plus CC-486', 'checkpoint inhibitors', 'pembrolizumab']","['progression-free survival (PFS', 'overall survival (OS), overall response rate (ORR)\xa0and safety', 'Median treatment duration', 'number of cycles', 'PFS', 'Median OS', 'ORR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0004475', 'cui_str': 'Azacitidine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",100.0,0.145538,"Median OS was 11.9 months versus not estimable (HR, 1.375; 90% CI, 0.830-2.276; P = 0.2968); ORR was 20% versus 14%.","[{'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Levy', 'Affiliation': 'Johns Hopkins Sidney Kimmel Cancer Center, Washington, DC, USA. Electronic address: blevy11@jhmi.edu.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Giaccone', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Besse', 'Affiliation': 'Department of Cancer Medicine, Gustave Roussy, Villejuif and Paris-Sud University, Orsay, France.'}, {'ForeName': 'Enriqueta', 'Initials': 'E', 'LastName': 'Felip', 'Affiliation': ""Hospital University Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Marina Chiara', 'Initials': 'MC', 'LastName': 'Garassino', 'Affiliation': 'Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Domine Gomez', 'Affiliation': 'Instituto de Investigacion Sanitaria-Fundación Jimenez Diaz (IIS- FJD), Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Garrido', 'Affiliation': 'IRYCIS, Hospital Universitario Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Piperdi', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Ponce-Aix', 'Affiliation': 'Hospital Universitario 12 de Octubre, Universidad Complutense, CNIO and CiberOnc, Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Menezes', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Kyle J', 'Initials': 'KJ', 'LastName': 'MacBeth', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Risueño', 'Affiliation': 'Celgene Institute for Translational Research Europe, Seville, Spain.'}, {'ForeName': 'Ruta', 'Initials': 'R', 'LastName': 'Slepetis', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Abderrahim', 'Initials': 'A', 'LastName': 'Fandi', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'Hospital Universitario 12 de Octubre, Universidad Complutense, CNIO and CiberOnc, Madrid, Spain. Electronic address: lpazaresr@seom.org.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2018.11.028']
303,32320844,Protocol for an embedded pragmatic clinical trial to test the effectiveness of Aliviado Dementia Care in improving quality of life for persons living with dementia and their informal caregivers.,"INTRODUCTION


Persons living with Alzheimer's disease and related dementias (ADRD) frequently experience pain and behavioral and psychological symptoms of dementia (BPSD) which decrease quality of life (QOL) and influence caregiver burden. Home healthcare professionals however may underrecognize or lack the ability to manage BPSD.
INTERVENTION


This protocol describes an ADRD palliative quality assurance performance improvement program for home healthcare, Aliviado Dementia Care-Home Health Edition. It includes training, mentoring, and a toolbox containing intervention strategies.
METHODS


This embedded pragmatic clinical trial will utilize a multi-site, cluster randomized control design. Recruitment will occur from three home healthcare agencies located in New Jersey, Utah, and Florida. At each agency, care teams will be randomized as clusters and assigned to either the Aliviado Dementia Care program or usual care. We plan to enroll 345 persons living with ADRD and their informal caregiver dyads. The primary outcome will be to measure QOL in both the person living with ADRD and their informal caregiver, and emergency department visits and hospital admissions. Secondary outcomes in the person living with ADRD will include the examination of pain, BPSD, antipsychotic and analgesic use. Secondary outcomes in caregivers include burden, depressive symptoms, functional health and wellbeing, and healthcare utilization.
CONCLUSION


This study will be the first large-scale embedded pragmatic clinical trial in home healthcare focused on care quality and outcomes in addressing QOL in ADRD. If proven successful, the intervention can then be disseminated to agencies throughout the country to improve the quality of care for this vulnerable, underserved population.
TRIAL REGISTRATION


Clinical Trials.gov: NCT03255967.",2020,"If proven successful, the intervention can then be disseminated to agencies throughout the country to improve the quality of care for this vulnerable, underserved population.
","[""Persons living with Alzheimer's disease and related dementias (ADRD"", '345 persons living with ADRD and their informal caregiver dyads', 'persons living with dementia and their informal caregivers']","['Aliviado Dementia Care', 'Aliviado Dementia Care program or usual care']","['caregivers include burden, depressive symptoms, functional health and wellbeing, and healthcare utilization', 'person living with ADRD will include the examination of pain, BPSD, antipsychotic and analgesic use', 'quality of life (QOL', 'quality of life', 'QOL in both the person living with ADRD and their informal caregiver, and emergency department visits and hospital admissions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}]","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",,0.117164,"If proven successful, the intervention can then be disseminated to agencies throughout the country to improve the quality of care for this vulnerable, underserved population.
","[{'ForeName': 'Alycia A', 'Initials': 'AA', 'LastName': 'Bristol', 'Affiliation': 'NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Convery', 'Affiliation': 'The Hartford Institute for Geriatric Nursing, NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Sotelo', 'Affiliation': 'The Hartford Institute for Geriatric Nursing, NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Schneider', 'Affiliation': 'NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Shih-Yin', 'Initials': 'SY', 'LastName': 'Lin', 'Affiliation': 'NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Fletcher', 'Affiliation': 'NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Rupper', 'Affiliation': 'University of Utah School of Medicine, United States; George E. Wahlen Department of Veterans Affairs Medical Center, VA Salt Lake City Health Care System, Geriatric Research, Education and Clinical Center, Salt Lake City, UT, United States.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Galvin', 'Affiliation': 'Comprehensive Center for Brain Health, University of Miami Miller School of Medicine, United States.'}, {'ForeName': 'Abraham A', 'Initials': 'AA', 'LastName': 'Brody', 'Affiliation': 'The Hartford Institute for Geriatric Nursing, NYU Rory Meyers College of Nursing, United States. Electronic address: Ab.Brody@nyu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106005']
304,32187881,"Licogliflozin, a Novel SGLT1 and 2 Inhibitor: Body Weight Effects in a Randomized Trial in Adults with Overweight or Obesity.","OBJECTIVE


The aim of this study was to explore the dose response of licogliflozin, a dual inhibitor of sodium/glucose cotransporter 1 (SGLT1) and 2 (SGLT2), by evaluating change in body weight in adults with overweight or obesity.
METHODS


This dose-response analysis evaluated change in body weight following 24 weeks with four once-daily and twice-daily licogliflozin doses (2.5-150 mg) versus placebo (primary end point). A further 24-week analysis evaluated the efficacy and safety of two once-daily licogliflozin doses in maintaining initial weight reduction.
RESULTS


Licogliflozin once daily or twice daily produced a significant dose-response signal for weight loss versus placebo (P < 0.0001). However, mean adjusted percent changes in body weight after 24 weeks were modest, ranging from -0.45% to -3.83% (in the 50 mg twice daily group [95% CI: -5.26% to -2.48%]; n = 75). Responder analysis of ≥ 5% weight loss at week 24 revealed significant differences versus placebo, which were most pronounced with highest doses of 50 mg twice daily (45.3%) and 150 mg once daily (42.9%) (both P < 0.01). While weight loss was greater at higher doses, gastrointestinal adverse events were also more frequent. The 50-mg once-daily dose had perhaps the best balance between efficacy and tolerability.
CONCLUSIONS


Licogliflozin produced significant reductions in body weight versus placebo. However, the magnitude of weight reduction was modest.",2020,"RESULTS


Licogliflozin once daily or twice daily produced a significant dose-response signal for weight loss versus placebo (P < 0.0001).","['Adults with Overweight or Obesity', 'adults with overweight or obesity']","['licogliflozin, a dual inhibitor of sodium/glucose cotransporter 1 (SGLT1)\xa0and 2\xa0(SGLT2', 'placebo', 'Licogliflozin', 'licogliflozin']","['body weight', 'efficacy and tolerability', 'weight loss', 'efficacy and safety', 'gastrointestinal adverse events', 'weight reduction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0643053,"RESULTS


Licogliflozin once daily or twice daily produced a significant dose-response signal for weight loss versus placebo (P < 0.0001).","[{'ForeName': 'Harold E', 'Initials': 'HE', 'LastName': 'Bays', 'Affiliation': 'Louisville Metabolic and Atherosclerosis Research Center, Louisville, Kentucky, USA.'}, {'ForeName': 'Plamen', 'Initials': 'P', 'LastName': 'Kozlovski', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Shao', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Proot', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Keefe', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22764']
305,31617739,Short-term water deprivation does not increase blood pressure variability or impair neurovascular function in healthy young adults.,"High dietary salt increases arterial blood pressure variability (BPV) in salt-resistant, normotensive rodents and is thought to result from elevated plasma [Na + ] sensitizing central sympathetic networks. Our purpose was to test the hypothesis that water deprivation (WD)-induced elevations in serum [Na + ] augment BPV via changes in baroreflex function and sympathetic vascular transduction in humans. In a randomized crossover fashion, 35 adults [17 female/18 male, age: 25 ± 4 yr, systolic/diastolic blood pressure (BP): 107 ± 11/60 ± 7 mmHg, body mass index: 23 ± 3 kg/m 2 ] completed two hydration protocols: a euhydration control condition (CON) and a stepwise reduction in water intake over 3 days, concluding with 16 h of WD. We assessed blood and urine electrolyte concentrations and osmolality, resting muscle sympathetic nerve activity (MSNA; peroneal microneurography; 18 paired recordings), beat-to-beat BP (photoplethysmography), common femoral artery blood flow (Doppler ultrasound), and heart rate (single-lead ECG). A subset of participants ( n  = 25) underwent ambulatory BP monitoring during  day 3  of each protocol. We calculated average real variability as an index of BPV. WD increased serum [Na + ] (141.0 ± 2.3 vs. 142.1 ± 1.7 mmol/L,  P  < 0.01) and plasma osmolality (288 ± 4 vs. 292 ± 5 mosmol/kg H 2 O,  P  < 0.01). However, WD did not increase beat-to-beat (1.9 ± 0.4 vs. 1.8 ± 0.4 mmHg,  P  = 0.24) or ambulatory daytime (9.6 ± 2.1 vs. 9.4 ± 3.3 mmHg,  P  = 0.76) systolic BPV. Additionally, sympathetic baroreflex sensitivity ( P  = 0.20) and sympathetic vascular transduction were not different after WD ( P  = 0.17 for peak Δmean BP following spontaneous MSNA bursts). These findings suggest that, despite modestly increasing serum [Na + ], WD does not affect BPV, arterial baroreflex function, or sympathetic vascular transduction in healthy young adults.",2020,"Additionally, sympathetic baroreflex sensitivity (p=0.20) and sympathetic vascular transduction were not different after WD (p=0.17 for peak","['35 adults (17F/18M, age: 25±4 years, systolic/diastolic BP: 107±11/60±7 mmHg, body mass index: 23±3 kg•m -2 ) completed two', 'healthy young adults', 'humans']","['High dietary salt', 'ambulatory BP monitoring', 'hydration protocols: a euhydration control condition (CON) and a step-wise reduction in water intake over three days concluding with 16-hours of WD']","['beat-to-beat', 'plasma osmolality', 'BPV, arterial baroreflex function, or sympathetic vascular transduction', 'ambulatory daytime', 'blood and urine electrolyte concentrations and osmolality, resting muscle sympathetic nerve activity (MSNA; peroneal microneurography; 18 paired recordings), beat-to-beat BP (photoplethysmography), common femoral artery blood flow (Doppler ultrasound), and heart rate (single-lead ECG', 'WD increased serum [Na + ', 'sympathetic vascular transduction', 'systolic BPV', 'sympathetic baroreflex sensitivity', 'arterial blood pressure variability (BPV', 'blood pressure variability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0013123', 'cui_str': 'Water Intake'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}]","[{'cui': 'C0860721', 'cui_str': 'Plasma osmolality (observable entity)'}, {'cui': 'C0531207', 'cui_str': 'bpV(phen)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0206162', 'cui_str': 'Reflex, Baroreceptor'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0587362', 'cui_str': 'Electrolytes measurement, urine (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4301987', 'cui_str': 'Osmolality (property)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure (body structure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0442035', 'cui_str': 'Peroneal (qualifier value)'}, {'cui': 'C0447105', 'cui_str': 'Common femoral artery (body structure)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",35.0,0.0899748,"Additionally, sympathetic baroreflex sensitivity (p=0.20) and sympathetic vascular transduction were not different after WD (p=0.17 for peak","[{'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Watso', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, Delaware.'}, {'ForeName': 'Austin T', 'Initials': 'AT', 'LastName': 'Robinson', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, Delaware.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Babcock', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, Delaware.'}, {'ForeName': 'Kamila U', 'Initials': 'KU', 'LastName': 'Migdal', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, Delaware.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Wenner', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, Delaware.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Stocker', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, Delaware.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00149.2019']
306,31320277,Controlling faecal incontinence in women by performing anal exercises with biofeedback or loperamide: a randomised clinical trial.,"BACKGROUND


Well designed, large comparative effectiveness trials assessing the efficacy of primary interventions for faecal incontinence are few in number. The objectives of this study were to compare different combinations of anorectal manometry-assisted biofeedback, loperamide, education, and oral placebo.
METHODS


In this randomised factorial trial, participants were recruited from eight clinical sites in the USA. Women with at least one episode of faecal incontinence per month in the past 3 months were randomly assigned 0·5:1:1:1 to one of four groups: oral placebo plus education only, placebo plus anorectal manometry-assisted biofeedback, loperamide plus education only, and loperamide plus anorectal manometry-assisted biofeedback. Participants received 2 mg per day of loperamide or oral placebo with the option of dose escalation or reduction. Women assigned to biofeedback received six visits, including strength and sensory biofeedback training. All participants received a standardised faecal incontinence patient education pamphlet and were followed for 24 weeks after starting treatment. The primary endpoint was change in St Mark's (Vaizey) faecal incontinence severity score between baseline and 24 weeks, analysed by intention-to-treat using general linear mixed modelling. Investigators, interviewers, and outcome evaluators were masked to biofeedback assignment. Participants and all study staff other than the research pharmacist were masked to medication assignment. Randomisation took place within the electronic data capture system, was stratified by site using randomly permuted blocks (block size 7), and the sizes of the blocks and the allocation sequence were known only to the data coordinating centre. This trial is registered with ClinicalTrials.gov, number NCT02008565.
FINDINGS


Between April 1, 2014, and Sept 30, 2015, 377 women were enrolled, of whom 300 were randomly assigned to placebo plus education (n=42), placebo plus biofeedback (n=84), loperamide plus education (n=88), and the combined intervention of loperamide plus biofeedback (n=86). At 24 weeks, there were no differences between loperamide versus placebo (model estimated score change -1·5 points, 95% CI -3·4 to 0·4, p=0·12), biofeedback versus education (-0·7 points, -2·6 to 1·2, p=0·47), and loperamide and biofeedback versus placebo and biofeedback (-1·9 points, -4·1 to 0·3, p=0·092) or versus loperamide plus education (-1·1 points, -3·4 to 1·1, p=0·33). Constipation was the most common grade 3 or higher adverse event and was reported by two (2%) of 86 participants in the loperamide and biofeedback group and two (2%) of 88 in the loperamide plus education group. The percentage of participants with any serious adverse events did not differ between the treatment groups. Only one serious adverse event was considered related to treatment (small bowel obstruction in the placebo and biofeedback group).
INTERPRETATION


In women with normal stool consistency and faecal incontinence bothersome enough to seek treatment, we were unable to find evidence against the null hypotheses that loperamide is equivalent to placebo, that anal exercises with biofeedback is equivalent to an educational pamphlet, and that loperamide and biofeedback are equivalent to oral placebo and biofeedback or loperamide plus an educational pamphlet. Because these are common first-line treatments for faecal incontinence, clinicians could consider combining loperamide, anal manometry-assisted biofeedback, and a standard educational pamphlet, but this is likely to result in only negligible improvement over individual therapies and patients should be counselled regarding possible constipation.
FUNDING


Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women's Health.",2019,"Only one serious adverse event was considered related to treatment (small bowel obstruction in the placebo and biofeedback group).
","['Between April 1, 2014, and Sept 30, 2015, 377 women were enrolled, of whom 300', 'Women with at least one episode of faecal incontinence per month in the past 3 months', 'participants were recruited from eight clinical sites in the USA', 'women by performing']","['placebo plus education', 'anorectal manometry-assisted biofeedback, loperamide, education, and oral placebo', 'placebo', 'standardised faecal incontinence patient education pamphlet', 'loperamide or oral placebo', 'strength and sensory biofeedback training', 'anal exercises with biofeedback or loperamide', 'placebo plus biofeedback (n=84), loperamide plus education (n=88), and the combined intervention of loperamide plus biofeedback', 'oral placebo plus education only, placebo plus anorectal manometry-assisted biofeedback, loperamide plus education only, and loperamide plus anorectal manometry-assisted biofeedback']","['Constipation', ""change in St Mark's (Vaizey) faecal incontinence severity score"", 'percentage of participants with any serious adverse events']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0374190', 'cui_str': 'Anorectal manometry'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0023992', 'cui_str': 'Loperamide'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2939124', 'cui_str': 'Anal (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",377.0,0.529028,"Only one serious adverse event was considered related to treatment (small bowel obstruction in the placebo and biofeedback group).
","[{'ForeName': 'J Eric', 'Initials': 'JE', 'LastName': 'Jelovsek', 'Affiliation': ""Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, OH, USA; Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, USA. Electronic address: eric.jelovsek@duke.edu.""}, {'ForeName': 'Alayne D', 'Initials': 'AD', 'LastName': 'Markland', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA; Birmingham/Atlanta Geriatric Research, Education, and Clinical Center, Birmingham, AL, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Whitehead', 'Affiliation': 'Department of Gastroenterology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Barber', 'Affiliation': ""Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, OH, USA; Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, USA.""}, {'ForeName': 'Diane K', 'Initials': 'DK', 'LastName': 'Newman', 'Affiliation': 'Division of Urology, Department of Surgery, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Rebecca G', 'Initials': 'RG', 'LastName': 'Rogers', 'Affiliation': ""Departments of Obstetrics and Gynecology and Surgery, University of New Mexico Health Sciences Center, Albuquerque, NM, USA; Department of Women's Health, Dell Medical School, University of Texas at Austin, Austin, TX, USA.""}, {'ForeName': 'Keisha', 'Initials': 'K', 'LastName': 'Dyer', 'Affiliation': 'Department of Obstetrics and Gynecology, Kaiser Permanente, San Diego, CA, USA.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Visco', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Sutkin', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Magee-Womens Research Institute, Pittsburgh, PA, USA; Department of Obstetrics and Gynecology, University of Missouri, Kansas City, MO, USA.'}, {'ForeName': 'Halina M', 'Initials': 'HM', 'LastName': 'Zyczynski', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Magee-Womens Research Institute, Pittsburgh, PA, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Carper', 'Affiliation': 'RTI International, Research Triangle Park, NC, USA.'}, {'ForeName': 'Susan F', 'Initials': 'SF', 'LastName': 'Meikle', 'Affiliation': 'Northwest Texas Physician Group, Amarillo, TX, USA.'}, {'ForeName': 'Vivian W', 'Initials': 'VW', 'LastName': 'Sung', 'Affiliation': 'Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Marie G', 'Initials': 'MG', 'LastName': 'Gantz', 'Affiliation': 'RTI International, Research Triangle Park, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30193-1']
307,31357206,Pharmacological mechanisms of interhemispheric signal propagation: a TMS-EEG study.,"Interhemispheric connections across the corpus callosum have a predominantly inhibitory effect. Previous electrophysiology studies imply that local inhibitory circuits are responsible for inducing transcallosal inhibition, likely through inhibitory GABA B -mediated neurotransmission. We investigated the neurochemical mechanisms involved in interhemispheric connectivity by measuring transcranial magnetic stimulation (TMS)-induced interhemispheric signal propagation (ISP) in the motor cortex and dorsolateral prefrontal cortex (DLPFC) with electroencephalography (EEG) recordings under the pharmacological effects of baclofen, L-DOPA, dextromethorphan, and rivastigmine. We hypothesized that for both stimulated regions, GABA B  receptor agonist baclofen would decrease ISP when compared against baseline while drugs that target other neurotransmitter systems (dopaminergic, acetylcholinergic, and glutamatergic systems) would have no effect on ISP. Twelve right-handed healthy volunteers completed this study and underwent TMS across five sessions in a randomized order. In the motor cortex, participants showed a significant decrease in ISP under baclofen, but not in the other drug conditions. There were no drug-induced changes in ISP in the DLPFC and baseline ISP did not differ across experimental sessions for both brain regions. Together, our results suggest that the inhibitory effects observed with interhemispheric signal transmission are mediated by a population of interneurons involving GABA B  receptor neurotransmission. Inhibitory mechanisms of ISP may be more salient for motor-related functions in the motor cortex than for cognitive control in the DLPFC. These findings are a fundamental step in advancing our understanding of interhemispheric connectivity and may be used to identify treatments for disorders in which transcallosal transmission is dysfunctional.",2020,"In the motor cortex, participants showed a significant decrease in ISP under baclofen, but not in the other drug conditions.",['Twelve right-handed healthy volunteers'],"['baclofen, L-DOPA, dextromethorphan, and rivastigmine', 'TMS', 'transcranial magnetic stimulation (TMS)-induced interhemispheric signal propagation (ISP']","['ISP under baclofen', 'ISP']","[{'cui': 'C0344333', 'cui_str': 'Right handed (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0649350', 'cui_str': 'rivastigmine'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}]",12.0,0.0545946,"In the motor cortex, participants showed a significant decrease in ISP under baclofen, but not in the other drug conditions.","[{'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Hui', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Zomorrodi', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Lioumis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Salavati', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada. Jeff.Daskalakis@camh.ca.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0468-7']
308,32092760,Modulation of the antidepressant effects of ketamine by the mTORC1 inhibitor rapamycin.,"Twenty-four hours after administration, ketamine exerts rapid and robust antidepressant effects that are thought to be mediated by activation of the mechanistic target of rapamycin complex 1 (mTORC1). To test this hypothesis, depressed patients were pretreated with rapamycin, an mTORC1 inhibitor, prior to receiving ketamine. Twenty patients suffering a major depressive episode were randomized to pretreatment with oral rapamycin (6 mg) or placebo 2 h prior to the intravenous administration of ketamine 0.5 mg/kg in a double-blind cross-over design with treatment days separated by at least 2 weeks. Depression severity was assessed using Montgomery-Åsberg Depression Rating Scale (MADRS). Rapamycin pretreatment did not alter the antidepressant effects of ketamine at the 24-h timepoint. Over the subsequent 2-weeks, we found a significant treatment by time interaction (F (8,245)  = 2.02, p = 0.04), suggesting a prolongation of the antidepressant effects of ketamine by rapamycin. Two weeks following ketamine administration, we found higher response (41%) and remission rates (29%) following rapamycin + ketamine compared to placebo + ketamine (13%, p = 0.04, and 7%, p = 0.003, respectively). In summary, single dose rapamycin pretreatment failed to block the antidepressant effects of ketamine, but it prolonged ketamine's antidepressant effects. This observation raises questions about the role of systemic vs. local blockade of mTORC1 in the antidepressant effects of ketamine, provides preliminary evidence that rapamycin may extend the benefits of ketamine, and thereby potentially sheds light on mechanisms that contribute to depression relapse after ketamine administration.",2020,"Two weeks following ketamine administration, we found higher response (41%) and remission rates (29%) following rapamycin + ketamine compared to placebo + ketamine (13%, p = 0.04, and 7%, p = 0.003, respectively).",['Twenty patients suffering a major depressive episode'],"['rapamycin\u2009+\u2009ketamine', 'placebo', 'ketamine', 'Rapamycin', 'rapamycin', 'placebo\u2009+\u2009ketamine', 'rapamycin, an mTORC1 inhibitor, prior to receiving ketamine', 'oral rapamycin']","['remission rates', 'Montgomery-Åsberg Depression Rating Scale (MADRS', 'Depression severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3888046', 'cui_str': 'mTORC1 Complex'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0810233,"Two weeks following ketamine administration, we found higher response (41%) and remission rates (29%) following rapamycin + ketamine compared to placebo + ketamine (13%, p = 0.04, and 7%, p = 0.003, respectively).","[{'ForeName': 'Chadi G', 'Initials': 'CG', 'LastName': 'Abdallah', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA. chadi.abdallah@yale.edu.'}, {'ForeName': 'Lynnette A', 'Initials': 'LA', 'LastName': 'Averill', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Selin', 'Initials': 'S', 'LastName': 'Goktas', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Prerana', 'Initials': 'P', 'LastName': 'Purohit', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Mohini', 'Initials': 'M', 'LastName': 'Ranganathan', 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Sherif', 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Kyung-Heup', 'Initials': 'KH', 'LastName': 'Ahn', 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Deepak Cyril', 'Initials': 'DC', 'LastName': ""D'Souza"", 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Formica', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Southwick', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Duman', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0644-9']
309,31889508,Impact of Daily Preventive Zinc or Therapeutic Zinc Supplementation for Diarrhea on Plasma Biomarkers of Environmental Enteric Dysfunction among Rural Laotian Children: A Randomized Controlled Trial.,"Environmental enteric dysfunction (EED) may be ameliorated by zinc supplementation. The objective of this study was to investigate the impact of different forms of zinc supplementation on biomarkers of EED (i.e., plasma citrulline, kynurenine, and tryptophan concentrations and the kynurenine:tryptophan [KT] ratio) among young Laotian children. In a double-blind randomized controlled trial, 3,407 children aged 6-23 months were randomized into one of four groups: daily preventive zinc dispersible tablets (PZ; 7 mg zinc), daily multiple micronutrient powders (MNP; 10 mg zinc, 6 mg iron, and 13 other micronutrients), therapeutic zinc supplements for diarrhea treatment (TZ; 20 mg/day for 10 days), or daily placebo powder, and followed up for ∼36 weeks. Plasma samples at baseline and endline for 359 children were analyzed for citrulline, kynurenine, and tryptophan concentrations. At baseline, the prevalence of stunting and zinc deficiency was 37% and 76.5%, respectively. The mean plasma citrulline, kynurenine, and tryptophan concentrations were 24.6 ± 5.4 µmol/L, 3.27 ± 0.83 µmol/L, and 72.3 ± 12.9 µmol/L, respectively; the mean KT ratio (×1,000) was 45.9 ± 12.0. At endline, neither plasma citrulline, kynurenine, or tryptophan concentrations, nor the KT ratio differed among intervention groups ( P  > 0.05). In this population, PZ, MNP, and TZ had no overall effect on plasma concentrations of citrulline, kynurenine, and tryptophan, or the KT ratio. The need remains to better understand the etiology of EED, and the development of biomarkers to diagnose EED and evaluate the impact of interventions.",2020,"At endline, neither plasma citrulline, kynurenine, or tryptophan concentrations, nor the KT ratio differed among intervention groups ( P  > 0.05).","['3,407 children aged 6-23 months', '359 children', 'young Laotian children', 'Rural Laotian Children']","['Daily Preventive Zinc and Therapeutic Zinc Supplementation', 'zinc supplementation', 'daily preventive zinc dispersible tablets (PZ; 7 mg zinc), daily multiple micronutrient powders (MNPs; 10 mg zinc, 6 mg iron, and 13 other micronutrients), therapeutic zinc supplements for diarrhea treatment (TZ; 20 mg/day for 10 days), or daily placebo powder']","['prevalence of stunting and zinc deficiency', 'biomarkers of EED (i.e., plasma citrulline, kynurenine, and tryptophan concentrations and the kynurenine:tryptophan [KT] ratio', 'plasma citrulline, kynurenine, or tryptophan concentrations, nor the KT ratio', 'plasma concentrations of citrulline, kynurenine, and tryptophan, or the KT ratio', 'mean plasma citrulline, kynurenine, and tryptophan concentrations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C3541396', 'cui_str': 'Zinc'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}, {'cui': 'C0235950', 'cui_str': 'Zinc deficiency (disorder)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0022818', 'cui_str': 'Benzenebutanoic acid, alpha,2-diamino-gamma-oxo-'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",359.0,0.334817,"At endline, neither plasma citrulline, kynurenine, or tryptophan concentrations, nor the KT ratio differed among intervention groups ( P  > 0.05).","[{'ForeName': 'K Ryan', 'Initials': 'KR', 'LastName': 'Wessells', 'Affiliation': 'Department of Nutrition, Institute for Global Nutrition, University of California, Davis, Davis, California.'}, {'ForeName': 'Guy-Marino', 'Initials': 'GM', 'LastName': 'Hinnouho', 'Affiliation': 'Department of Nutrition, Institute for Global Nutrition, University of California, Davis, Davis, California.'}, {'ForeName': 'Maxwell A', 'Initials': 'MA', 'LastName': 'Barffour', 'Affiliation': 'Public Health Program, College of Health and Human Services, Missouri State University, Springfield, Missouri.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition, Institute for Global Nutrition, University of California, Davis, Davis, California.'}, {'ForeName': 'Sengchanh', 'Initials': 'S', 'LastName': 'Kounnavong', 'Affiliation': ""Lao Tropical and Public Health Institute, Vientiane, Lao People's Democratic Republic.""}, {'ForeName': 'Chidchamai', 'Initials': 'C', 'LastName': 'Kewcharoenwong', 'Affiliation': 'Faculty of Associated Medical Sciences, The Centre for Research and Development of Medical Diagnostic Laboratories, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Ganjana', 'Initials': 'G', 'LastName': 'Lertmemongkolchai', 'Affiliation': 'Faculty of Associated Medical Sciences, The Centre for Research and Development of Medical Diagnostic Laboratories, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Gertrud U', 'Initials': 'GU', 'LastName': 'Schuster', 'Affiliation': 'Agricultural Research Service, Western Human Nutrition Research Center, US Department of Agriculture, Davis, California.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Stephensen', 'Affiliation': 'Agricultural Research Service, Western Human Nutrition Research Center, US Department of Agriculture, Davis, California.'}, {'ForeName': 'Sonja Y', 'Initials': 'SY', 'LastName': 'Hess', 'Affiliation': 'Department of Nutrition, Institute for Global Nutrition, University of California, Davis, Davis, California.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0584']
310,32321767,Quality of life of locally advanced cervical cancer patients after neoadjuvant chemotherapy followed by chemoradiation versus chemoradiation alone (CIRCE trial): a randomized phase II trial.,"OBJECTIVE


The CIRCE trial (NCT01973101) investigated the efficacy, safety, and quality of life of the addition of neoadjuvant chemotherapy with cisplatin and gemcitabine to standard chemoradiation for locally advanced cervical cancer (stages IIB-IVA). The impact of both treatment arms on quality of life is reported in the present study.
METHODS


Patients completed the European Organization of Research and Treatment of Cancer questionnaire QLQ-C30 and CX24 before treatment and at 3, 6, 9, and 12 months after treatment. Linear mixed models were fitted to analyze differences in quality of life over time and between groups. Differences in mean quality of life scales >10 points and p<0.05 were considered clinically relevant and statistically significant, respectively. Inclusion criteria were: (1) histological diagnosis of locally advanced invasive carcinoma of the uterine cervix, International Federation of Gynecology and Obstetrics stages IIB-IVA; (2) signed informed consent to participate in the CIRCE trial; and (3) answered at least one quality of life questionnaire. Excluded were patients who did not complete any quality of life questionnaire. Relevant exclusion criteria for the CIRCE trial included Eastern Cooperative Oncology Group performance status >2 and peripheral neuropathy >2. Mann-Whitney U tests were performed to assess differences between groups in quality of life at baseline. To evaluate differences between treatment arms, linear mixed models were fitted using the transformed quality of life scores as a dependent variable and time of follow-up and study arm as factors.
RESULTS


A total of 107 patients were enrolled (n=55 neoadjuvant chemotherapy arm; n=52 chemoradiation arm). Quality of life compliance rates were higher for the chemoradiation group at every assessment time (ranging from 75-86.5% in the chemoradiation arm vs 55-81.8% in the neoadjuvant chemotherapy arm). For quality of life results at baseline, no statistically significant difference between the groups was seen. For both groups, most scales showed improvements over time, except for worsening of the summary score, sexual enjoyment, peripheral neuropathy, and menopausal symptoms. For chemoradiation, body image was lower (p<0.001) and patients presented more lymphedema (p<0.001) and sexual worry (p<0.001) at 12 months compared with baseline. Comparing study arms, neoadjuvant chemotherapy showed significantly lower scores in the menopausal symptoms scale (p=0.03) and higher scores for sexual/vaginal functioning (p=0.01). At 12 months, clinical differences were seen only for body image and menopausal symptoms scale, with neoadjuvant chemotherapy presenting better body image scores and a lower burden of menopausal symptoms.
CONCLUSION


After treatment for locally advanced cervical cancer, patients improved in most quality of life aspects. However, worsening was observed in sexual enjoyment, peripheral neuropathy, and menopausal symptoms. To improve patients' quality of life, efforts should be made to prevent and treat these long term effects of locally advanced cervical cancer treatment.",2020,"Comparing study arms, neoadjuvant chemotherapy showed significantly lower scores in the menopausal symptoms scale (p=0.03) and higher scores for sexual/vaginal functioning (p=0.01).","['Inclusion criteria were: (1) histological diagnosis of locally advanced invasive carcinoma of the uterine cervix, International Federation of Gynecology and Obstetrics stages IIB-IVA; (2) signed informed consent to participate in the CIRCE trial; and (3) answered at least one quality of life questionnaire', 'locally advanced cervical cancer (stages IIB-IVA', '107 patients were enrolled (n=55 neoadjuvant chemotherapy arm; n=52 chemoradiation arm', 'Patients completed the European Organization of Research and Treatment of Cancer questionnaire QLQ-C30 and CX24 before treatment and at 3, 6, 9, and 12 months after treatment', 'locally advanced cervical cancer patients after neoadjuvant chemotherapy followed by chemoradiation versus chemoradiation alone (CIRCE trial']","['neoadjuvant chemotherapy', 'neoadjuvant chemotherapy with cisplatin and gemcitabine to standard chemoradiation']","['Quality of life', 'sexual/vaginal functioning', 'Quality of life compliance rates', 'menopausal symptoms scale', 'quality of life questionnaire', 'mean quality of life scales', 'body image and menopausal symptoms scale', 'worsening of the summary score, sexual enjoyment, peripheral neuropathy, and menopausal symptoms', 'sexual enjoyment, peripheral neuropathy, and menopausal symptoms', 'quality of life', 'lymphedema (p<0.001) and sexual worry', 'efficacy, safety, and quality of life']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0302592', 'cui_str': 'Carcinoma of cervix'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0441769', 'cui_str': 'Stage 2B'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424403', 'cui_str': 'Erotic feeling'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",107.0,0.0959925,"Comparing study arms, neoadjuvant chemotherapy showed significantly lower scores in the menopausal symptoms scale (p=0.03) and higher scores for sexual/vaginal functioning (p=0.01).","[{'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Nunes de Arruda', 'Affiliation': 'Sao Paulo University Faculty of Medicine, Sao Paulo, Brazil fernanda.arruda@fm.usp.br.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'da Costa', 'Affiliation': 'Universidade de Sao Paulo Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Bonadio', 'Affiliation': 'Oncology, Universidade de Sao Paulo Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Abraão', 'Initials': 'A', 'LastName': 'Dornellas', 'Affiliation': 'Universidade de Sao Paulo Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pereira', 'Affiliation': 'Universidade de Sao Paulo Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Geertruida H', 'Initials': 'GH', 'LastName': 'de Bock', 'Affiliation': 'Epidemiology, University of Groningen Faculty of Medical Sciences, Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Del Pilar Estevez Diz', 'Affiliation': 'Radiology and Oncology, Universidade de Sao Paulo Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, Sao Paulo, Brazil.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-001134']
311,32097252,Outcomes of Three- Versus Six-Monthly Dispensing of Antiretroviral Treatment (ART) for Stable HIV Patients in Community ART Refill Groups: A Cluster-Randomized Trial in Zimbabwe.,"INTRODUCTION


Multimonth dispensing (MMD) of antiretroviral treatment (ART) aims to reduce patient-related barriers to access long-term treatment and improve health system efficiency. However, randomized evidence of its clinical effectiveness is lacking. We compared MMD within community ART refill groups (CARGs) vs. standard-of-care facility-based ART delivery in Zimbabwe.
METHODS


A three-arm, cluster-randomized, pragmatic noninferiority trial was performed. Thirty health care facilities and associated CARGs were allocated to either ART collected three-monthly at facility (3MF, control); ART delivered three-monthly in CARGs (3MC); or ART delivered six-monthly in CARGs (6MC). Stable adults receiving ART ≥six months with baseline viral load (VL) <1000 copies/ml were eligible. Retention in ART care (primary outcome) and viral suppression (VS) 12 months after enrollment were compared, using regression models specified for clustering (ClinicalTrials.gov: NCT03238846).
RESULTS


4800 participants were recruited, 1919, 1335, and 1546 in arms 3MF, 3MC, and 6MC, respectively. For retention, the prespecified noninferiority limit (-3.25%, risk difference [RD]) was met for comparisons between all arms, 3MC (94.8%) vs. 3MF (93.0%), adjusted RD = 1.1% (95% CI: -0.5% to 2.8%); 6MC (95.5%) vs. 3MF: aRD = 1.2% (95% CI: -1.0% to 3.6%); and 6MC vs. 3MC: aRD = 0.1% (95% CI: -2.4% to 2.6%). VL completion at 12 months was 49%, 45%, and 8% in 3MF, 3MC, and 6MC, respectively. VS in 3MC (99.7%) was high and not different to 3MF (99.1%), relative risk = 1.0 (95% CI: 1.0-1.0). VS was marginally reduced in 6MC (92.9%) vs. 3MF, relative risk = 0.9 (95% CI: 0.9-1.0).
CONCLUSION


Retention in CARGs receiving three- and six-monthly MMD was noninferior versus standard-of-care facility-based ART delivery. VS in 3MC was high. VS in six-monthly CARGs requires further evaluation.",2020,"VL completion at 12 months was 49%, 45% and 8% in 3MF, 3MC and 6MC, respectively.","['Stable HIV Patients in Community ART Refill Groups', 'Stable adults receiving ART ≥six months with baseline viral load (VL) <1000 copies/ml were eligible', 'Thirty healthcare facilities and associated CARGs', '4800 participants were recruited; 1919, 1335 and 1546 in arms 3MF, 3MC and 6MC, respectively']","['Antiretroviral Treatment (ART', 'ART collected three-monthly at facility (3MF, control); ART delivered three-monthly in CARGs (3MC); or ART delivered six-monthly in CARGs (6MC', 'Zimbabwe', 'Multimonth dispensing (MMD) of antiretroviral treatment (ART']","['6MC', 'VL completion']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0585339', 'cui_str': 'q6mo'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}]",[],4800.0,0.363122,"VL completion at 12 months was 49%, 45% and 8% in 3MF, 3MC and 6MC, respectively.","[{'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Fatti', 'Affiliation': ""Kheth'Impilo AIDS Free Living, Cape Town, South Africa.""}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Ngorima-Mabhena', 'Affiliation': ""Kheth'Impilo, Harare, Zimbabwe.""}, {'ForeName': 'Eula', 'Initials': 'E', 'LastName': 'Mothibi', 'Affiliation': ""Kheth'Impilo AIDS Free Living, Cape Town, South Africa.""}, {'ForeName': 'Trish', 'Initials': 'T', 'LastName': 'Muzenda', 'Affiliation': ""Kheth'Impilo AIDS Free Living, Cape Town, South Africa.""}, {'ForeName': 'Regis', 'Initials': 'R', 'LastName': 'Choto', 'Affiliation': 'Ministry of Health and Child Care, Zimbabwe.'}, {'ForeName': 'Tonderai', 'Initials': 'T', 'LastName': 'Kasu', 'Affiliation': 'Ministry of Health and Child Care, Zimbabwe.'}, {'ForeName': 'Taurayi A', 'Initials': 'TA', 'LastName': 'Tafuma', 'Affiliation': 'FHI360, Zimbabwe.'}, {'ForeName': 'Nyika', 'Initials': 'N', 'LastName': 'Mahachi', 'Affiliation': 'FHI360, Zimbabwe.'}, {'ForeName': 'Kudakwashe C', 'Initials': 'KC', 'LastName': 'Takarinda', 'Affiliation': 'Ministry of Health and Child Care, Zimbabwe.'}, {'ForeName': 'Tsitsi', 'Initials': 'T', 'LastName': 'Apollo', 'Affiliation': 'Ministry of Health and Child Care, Zimbabwe.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Mugurungi', 'Affiliation': 'Ministry of Health and Child Care, Zimbabwe.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Chasela', 'Affiliation': 'EQUIP Health, Centurion, South Africa.'}, {'ForeName': 'Risa M', 'Initials': 'RM', 'LastName': 'Hoffman', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, David Geffen School of Medicine at the University of California, Los Angeles, USA.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Grimwood', 'Affiliation': ""Kheth'Impilo AIDS Free Living, Cape Town, South Africa.""}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002333']
312,32318777,Cyclosporine A prevents cardiac arrest-induced acute respiratory failure: a post-hoc analysis of the CYRUS trial.,,2020,,[],['Cyclosporine'],['cardiac arrest-induced acute respiratory failure'],[],"[{'cui': 'C0010592', 'cui_str': 'Cyclosporine'}]","[{'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}]",,0.195655,,"[{'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Kreitmann', 'Affiliation': ""Service de Médecine Intensive - Réanimation, Hospices Civils de Lyon, Hôpital Edouard Herriot, 5, place d'Arsonval, 69437, Lyon Cedex 03, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Argaud', 'Affiliation': ""Service de Médecine Intensive - Réanimation, Hospices Civils de Lyon, Hôpital Edouard Herriot, 5, place d'Arsonval, 69437, Lyon Cedex 03, France.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ovize', 'Affiliation': 'Faculté de médecine Lyon Est, Université de Lyon, Université Claude Bernard Lyon 1, 69373, Lyon, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Cour', 'Affiliation': ""Service de Médecine Intensive - Réanimation, Hospices Civils de Lyon, Hôpital Edouard Herriot, 5, place d'Arsonval, 69437, Lyon Cedex 03, France. martin.cour@chu-lyon.fr.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-020-06043-0']
313,32095393,Clinical Evaluation of an Off-the-Shelf Allogeneic Adipose Matrix for Soft Tissue Reconstruction.,"Biomaterials derived from human adipose extracellular matrix have shown promise in vitro and in animal studies as an off-the-shelf adipogenic matrix for sustained volume replacement. Herein, we report the results of a randomized prospective study conducted with allograft adipose matrix (AAM) grafted into the pannus of presurgical abdominoplasty patients 3 or 6 months before scheduled surgery. This is the first report of a longitudinal histologic analysis of AAM in clinical use.
Methods


Ten healthy patients undergoing elective abdominoplasty were recruited to receive AAM before surgery. Enrolled subjects were randomized into either a 3-month follow-up cohort or a 6-month follow-up cohort. Subjects were monitored for adverse events associated with AAM grafting in addition to undergoing serial biopsy. Following surgical excision of the pannus, representative samples from the AAM surgical sites were stained and evaluated with hematoxylin and eosin for tissue morphology, Masson's trichrome for collagen, and perilipin for adipocytes.
Results


All subjects tolerated AAM with no severe adverse events reported. At 3 months following implantation, AAM remained visible within the confines of the subjects' native surrounding adipose tissue with sparse adipocytes apparent within the matrix. By 6 months, AAM had remodeled and was primarily composed of perilipin-positive adipocytes. Histologic analysis confirmed tissue remodeling (hematoxylin and eosin), adipogenesis (perilipin), and angiogenesis (Masson's trichrome) occurred with the presence of AAM.
Conclusions


AAM is a safe, allogeneic, off-the-shelf regenerative matrix that is adipogenic and noninflammatory and promotes angiogenesis.",2020,All subjects tolerated AAM with no severe adverse events reported.,"['Ten healthy patients undergoing elective abdominoplasty were recruited to receive AAM before surgery', 'presurgical abdominoplasty patients 3 or 6 months before scheduled surgery']",['allograft adipose matrix (AAM'],"[""tissue remodeling (hematoxylin and eosin), adipogenesis (perilipin), and angiogenesis (Masson's trichrome""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0198542', 'cui_str': 'Abdominoplasty'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}]","[{'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0018964', 'cui_str': 'Hydroxybrasilin'}, {'cui': 'C0014448', 'cui_str': 'eosin'}, {'cui': 'C0596843', 'cui_str': 'Adipogenesis'}, {'cui': 'C0443326', 'cui_str': 'Trichrome (qualifier value)'}]",10.0,0.0256852,All subjects tolerated AAM with no severe adverse events reported.,"[{'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Kokai', 'Affiliation': 'Department of Plastic Surgery, University of Pittsburgh, Pittsburgh, Pa.'}, {'ForeName': 'Wesley N', 'Initials': 'WN', 'LastName': 'Sivak', 'Affiliation': 'Department of Plastic Surgery, University of Pittsburgh, Pittsburgh, Pa.'}, {'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Schilling', 'Affiliation': 'Department of Plastic Surgery, University of Pittsburgh, Pittsburgh, Pa.'}, {'ForeName': 'Arivarasan', 'Initials': 'A', 'LastName': 'Karunamurthy', 'Affiliation': 'Division of Molecular & Genomic Pathology, Pittsburgh, Pa.'}, {'ForeName': 'Francesco M', 'Initials': 'FM', 'LastName': 'Egro', 'Affiliation': 'Department of Plastic Surgery, University of Pittsburgh, Pittsburgh, Pa.'}, {'ForeName': 'M Asher', 'Initials': 'MA', 'LastName': 'Schusterman', 'Affiliation': 'Department of Plastic Surgery, University of Pittsburgh, Pittsburgh, Pa.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Minteer', 'Affiliation': 'Department of Plastic Surgery, University of Pittsburgh, Pittsburgh, Pa.'}, {'ForeName': 'Patsy', 'Initials': 'P', 'LastName': 'Simon', 'Affiliation': 'Department of Plastic Surgery, University of Pittsburgh, Pittsburgh, Pa.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': ""D'Amico"", 'Affiliation': 'Department of Plastic Surgery, Mount Sinai School of Medicine, New York, N.Y.'}, {'ForeName': 'J Peter', 'Initials': 'JP', 'LastName': 'Rubin', 'Affiliation': 'Department of Plastic Surgery, University of Pittsburgh, Pittsburgh, Pa.'}]",Plastic and reconstructive surgery. Global open,['10.1097/GOX.0000000000002574']
314,32320846,Proactive health support (PaHS) - telephone-based self-management support for persons at risk of hospital admission: Study protocol for a randomized controlled trial.,"BACKGROUND


A small proportion of patients account for most of the healthcare costs. Previous studies of supportive interventions have several methodological limitations and results are mixed. This article describes the protocol for Proactive Health Support: a national randomized controlled trial of telephone-based self-management support (ClinicalTrials.gov, NCT03628469). The main aim of the intervention is to reduce hospital admissions and improve quality of life at six months.
METHODS


A sample size of 4400 is needed and individuals with the highest risk of hospital admission in Denmark are invited by electronic communication and telephone to participate in a 1:1 randomized controlled trial. The intervention group receives one face-to-face start-up session followed by telephone sessions about individual goals regarding participants' knowledge, coping and need of healthcare. Quality of life was assessed with the mental health composite score of the SF-36v2 questionnaire. Primary analyses are done using the intention-to-treat principle.
DISCUSSION


The trial has been approved by The Regional Committee on Health Research Ethics (SJ-677). Intervention nurses do not assume clinical responsibility for the participants and the intervention is an addition to the general healthcare services. The intervention is complex due to challenging skills and behaviors required by nurses, individual tailoring of the intervention, and interacting intervention components. The study therefore includes process evaluation. The research program comprises: 1. Development initiation, 2. Intervention effect, 3. Cost-effectiveness, 4. Organizational implementation, and 5. Participants' experiences. Inclusion to the trial began April 9th, 2018, was completed July 1st, 2019 and follow-up will be completed February 1st, 2020.",2020,"This article describes the protocol for Proactive Health Support: a national randomized controlled trial of telephone-based self-management support (ClinicalTrials.gov, NCT03628469).","['persons at risk of hospital admission', ""Participants' experiences""]","[""intervention group receives one face-to-face start-up session followed by telephone sessions about individual goals regarding participants' knowledge, coping and need of healthcare"", 'Proactive health support (PaHS) - telephone-based self-management support']","['Cost-effectiveness', 'mental health composite score of the SF-36v2 questionnaire', 'Quality of life', 'hospital admissions and improve quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.110494,"This article describes the protocol for Proactive Health Support: a national randomized controlled trial of telephone-based self-management support (ClinicalTrials.gov, NCT03628469).","[{'ForeName': 'Kirstine Skov', 'Initials': 'KS', 'LastName': 'Benthien', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark. Electronic address: kirstine.skov.benthien@regionh.dk.'}, {'ForeName': 'Knud', 'Initials': 'K', 'LastName': 'Rasmussen', 'Affiliation': 'Production, Research and Innovation, Region Zealand, Sorø, Denmark. Electronic address: kra@regionsjaelland.dk.'}, {'ForeName': 'Camilla Palmhøj', 'Initials': 'CP', 'LastName': 'Nielsen', 'Affiliation': 'DEFACTUM - Social & Health Services and Labour Market, Aarhus, Denmark. Electronic address: camilla.palmhoj@rm.dk.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Hjarnaa', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark. Electronic address: louise.hjarnaa@regionh.dk.'}, {'ForeName': 'Maja Kjær', 'Initials': 'MK', 'LastName': 'Rasmussen', 'Affiliation': 'Centre for Innovative Medical Technology, Odense University Hospital, Odense, Denmark. Electronic address: maja.kjaer.rasmussen@rsyd.dk.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Kidholm', 'Affiliation': 'Centre for Innovative Medical Technology, Odense University Hospital, Odense, Denmark. Electronic address: kristian.kidholm@rsyd.dk.'}, {'ForeName': 'Berit Kjærside', 'Initials': 'BK', 'LastName': 'Nielsen', 'Affiliation': 'DEFACTUM - Social & Health Services and Labour Market, Aarhus, Denmark. Electronic address: beritnie@rm.dk.'}, {'ForeName': 'Nina Konstantin', 'Initials': 'NK', 'LastName': 'Nissen', 'Affiliation': 'DEFACTUM - Social & Health Services and Labour Market, Aarhus, Denmark. Electronic address: niniss@rm.dk.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Fredens', 'Affiliation': 'DEFACTUM - Social & Health Services and Labour Market, Aarhus, Denmark. Electronic address: mia.fredens@rm.dk.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Winther', 'Affiliation': 'Clinical Nursing Research Unit, Aalborg University Hospital, Aalborg, Denmark. Electronic address: susanne.winther@rn.dk.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Grønkjær', 'Affiliation': 'Clinical Nursing Research Unit, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. Electronic address: mette.groenkjaer@rn.dk.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Toft', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark. Electronic address: ulla.toft@regionh.dk.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106004']
315,32015556,Combination anti-HIV-1 antibody therapy is associated with increased virus-specific T cell immunity.,"Combination antiretroviral therapy (ART) is highly effective in controlling human immunodeficiency virus (HIV)-1 but requires lifelong medication due to the existence of a latent viral reservoir 1,2 . Potent broadly neutralizing antibodies (bNAbs) represent a potential alternative or adjuvant to ART. In addition to suppressing viremia, bNAbs may have T cell immunomodulatory effects as seen for other forms of immunotherapy 3 . However, this has not been established in individuals who are infected with HIV-1. Here, we document increased HIV-1 Gag-specific CD8 +  T cell responses in the peripheral blood of all nine study participants who were infected with HIV-1 with suppressed blood viremia, while receiving bNAb therapy during ART interruption 4 . Increased CD4 +  T cell responses were detected in eight individuals. The increased T cell responses were due both to newly detectable reactivity to HIV-1 Gag epitopes and the expansion of pre-existing measurable responses. These data demonstrate that bNAb therapy during ART interruption is associated with enhanced HIV-1-specific T cell responses. Whether these augmented T cell responses can contribute to bNAb-mediated viral control remains to be determined.",2020,"Here, we document increased HIV-1 Gag-specific CD8 +  T cell responses in the peripheral blood of all nine study participants who were infected with HIV-1 with suppressed blood viremia, while receiving bNAb therapy during ART interruption 4 .","['peripheral blood of all nine study participants who were infected with HIV-1 with suppressed blood viremia, while receiving bNAb therapy during ART interruption 4 ', 'individuals who are infected with HIV-1']","['Combination antiretroviral therapy (ART', 'Combination anti-HIV-1 antibody therapy']","['Increased CD4 +  T cell responses', 'HIV-1-specific T cell responses', 'increased T cell responses', 'HIV-1 Gag-specific CD8 +  T cell responses']","[{'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0369497', 'cui_str': 'Human immunodeficiency virus type 1 antibody'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0016927', 'cui_str': 'Gagging'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}]",9.0,0.0411462,"Here, we document increased HIV-1 Gag-specific CD8 +  T cell responses in the peripheral blood of all nine study participants who were infected with HIV-1 with suppressed blood viremia, while receiving bNAb therapy during ART interruption 4 .","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Niessl', 'Affiliation': ""Research Centre of the Centre Hospitalier de l'Université de Montréal (CRCHUM), Montreal, QC, Canada.""}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Baxter', 'Affiliation': ""Research Centre of the Centre Hospitalier de l'Université de Montréal (CRCHUM), Montreal, QC, Canada.""}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Mendoza', 'Affiliation': 'Laboratory of Molecular Immunology, The Rockefeller University, New York, NY, USA.'}, {'ForeName': 'Mila', 'Initials': 'M', 'LastName': 'Jankovic', 'Affiliation': 'Laboratory of Molecular Immunology, The Rockefeller University, New York, NY, USA.'}, {'ForeName': 'Yehuda Z', 'Initials': 'YZ', 'LastName': 'Cohen', 'Affiliation': 'Laboratory of Molecular Immunology, The Rockefeller University, New York, NY, USA.'}, {'ForeName': 'Allison L', 'Initials': 'AL', 'LastName': 'Butler', 'Affiliation': 'Laboratory of Molecular Immunology, The Rockefeller University, New York, NY, USA.'}, {'ForeName': 'Ching-Lan', 'Initials': 'CL', 'LastName': 'Lu', 'Affiliation': 'Laboratory of Molecular Immunology, The Rockefeller University, New York, NY, USA.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Dubé', 'Affiliation': ""Research Centre of the Centre Hospitalier de l'Université de Montréal (CRCHUM), Montreal, QC, Canada.""}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Shimeliovich', 'Affiliation': 'Laboratory of Molecular Immunology, The Rockefeller University, New York, NY, USA.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Gruell', 'Affiliation': 'Laboratory of Experimental Immunology, Institute of Virology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Klein', 'Affiliation': 'Laboratory of Experimental Immunology, Institute of Virology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Caskey', 'Affiliation': 'Laboratory of Molecular Immunology, The Rockefeller University, New York, NY, USA.'}, {'ForeName': 'Michel C', 'Initials': 'MC', 'LastName': 'Nussenzweig', 'Affiliation': 'Laboratory of Molecular Immunology, The Rockefeller University, New York, NY, USA. nussen@mail.rockefeller.edu.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Kaufmann', 'Affiliation': ""Research Centre of the Centre Hospitalier de l'Université de Montréal (CRCHUM), Montreal, QC, Canada. daniel.kaufmann@umontreal.ca.""}]",Nature medicine,['10.1038/s41591-019-0747-1']
316,32053828,Global connectivity and local excitability changes underlie antidepressant effects of repetitive transcranial magnetic stimulation.,"Repetitive transcranial magnetic stimulation (rTMS) is a commonly- used treatment for major depressive disorder (MDD). However, our understanding of the mechanism by which TMS exerts its antidepressant effect is minimal. Furthermore, we lack brain signals that can be used to predict and track clinical outcome. Such signals would allow for treatment stratification and optimization. Here, we performed a randomized, sham-controlled clinical trial and measured electrophysiological, neuroimaging, and clinical changes before and after rTMS. Patients (N = 36) were randomized to receive either active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC) for 20 consecutive weekdays. To capture the rTMS-driven changes in connectivity and causal excitability, resting fMRI and TMS/EEG were performed before and after the treatment. Baseline causal connectivity differences between depressed patients and healthy controls were also evaluated with concurrent TMS/fMRI. We found that active, but not sham rTMS elicited (1) an increase in dlPFC global connectivity, (2) induction of negative dlPFC-amygdala connectivity, and (3) local and distributed changes in TMS/EEG potentials. Global connectivity changes predicted clinical outcome, while both global connectivity and TMS/EEG changes tracked clinical outcome. In patients but not healthy participants, we observed a perturbed inhibitory effect of the dlPFC on the amygdala. Taken together, rTMS induced lasting connectivity and excitability changes from the site of stimulation, such that after active treatment, the dlPFC appeared better able to engage in top-down control of the amygdala. These measures of network functioning both predicted and tracked clinical outcome, potentially opening the door to treatment optimization.",2020,Patients (N = 36) were randomized to receive either active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC) for 20 consecutive weekdays.,"['Patients (N\u2009=\u200936', 'depressed patients and healthy controls', 'major depressive disorder (MDD']","['Repetitive transcranial magnetic stimulation (rTMS', 'active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC', 'TMS', 'repetitive transcranial magnetic stimulation', 'rTMS']","['connectivity and causal excitability, resting fMRI and TMS/EEG', 'global connectivity and TMS/EEG changes tracked clinical outcome', 'dlPFC global connectivity, (2) induction of negative dlPFC-amygdala connectivity, and (3) local and distributed changes in TMS/EEG potentials']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0450424', 'cui_str': 'To the left (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",36.0,0.0327488,Patients (N = 36) were randomized to receive either active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC) for 20 consecutive weekdays.,"[{'ForeName': 'Neir', 'Initials': 'N', 'LastName': 'Eshel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Corey J', 'Initials': 'CJ', 'LastName': 'Keller', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Mills-Finnerty', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Huemer', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Wright', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fonzo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Naho', 'Initials': 'N', 'LastName': 'Ichikawa', 'Affiliation': 'Department of Psychiatry and Neurosciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Carreon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Yee', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Shpigel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': ""Department of Neurology, Shenzhen People's Hospital, Shenzhen, China.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'McTeague', 'Affiliation': 'Department of Psychiatry, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Maron-Katz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA. amitetkin@stanford.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0633-z']
317,31086274,The effect of paired corticospinal-motoneuronal stimulation on maximal voluntary elbow flexion in cervical spinal cord injury: an experimental study.,"STUDY DESIGN


Randomised, controlled, crossover study.
OBJECTIVES


Paired corticospinal-motoneuronal stimulation (PCMS) involves repeatedly pairing stimuli to corticospinal neurones and motoneurones to induce changes in corticospinal transmission. Here, we examined whether PCMS could enhance maximal voluntary elbow flexion in people with cervical spinal cord injury.
SETTING


Neuroscience Research Australia, Sydney, Australia.
METHODS


PCMS comprised 100 pairs of transcranial magnetic and electrical peripheral nerve stimulation (0.1 Hz), timed so corticospinal potentials arrived at corticospinal-motoneuronal synapses 1.5 ms before antidromic motoneuronal potentials. On two separate days, sets of five maximal elbow flexions were performed by 11 individuals with weak elbow flexors post C4 or C5 spinal cord injury before and after PCMS or control (100 peripheral nerve stimuli) conditioning. During contractions, supramaximal biceps brachii stimulation elicited superimposed twitches, which were expressed as a proportion of resting twitches to give maximal voluntary activation. Maximal torque and electromyographic activity were also assessed.
RESULTS


Baseline median (range) maximal torque was 11 Nm (6-41 Nm) and voluntary activation was 92% (62-99%). Linear mixed modelling revealed no significant differences between PCMS and control protocols after conditioning (maximal torque: p = 0.87, superimposed twitch: p = 0.87, resting twitch: p = 0.44, voluntary activation: p = 0.36, biceps EMG: p = 0.25, brachioradialis EMG: 0.67).
CONCLUSIONS


Possible explanations for the lack of effect include a potential ceiling effect for voluntary activation, or that PCMS may be less effective for elbow flexors than distal muscles. Despite results, previous studies suggest that PCMS is worthy of further investigation.",2019,"Linear mixed modelling revealed no significant differences between PCMS and control protocols after conditioning (maximal torque: p = 0.87, superimposed twitch: p = 0.87, resting twitch: p = 0.44, voluntary activation: p = 0.36, biceps EMG: p = 0.25, brachioradialis EMG: 0.67).
","['cervical spinal cord injury', 'Neuroscience Research Australia, Sydney, Australia', '11 individuals with weak elbow flexors post C4 or C5 spinal cord injury before and after', 'people with cervical spinal cord injury', 'PCMS comprised 100 pairs of']","['PCMS or control (100 peripheral nerve stimuli) conditioning', 'Paired corticospinal-motoneuronal stimulation (PCMS', 'PCMS', 'transcranial magnetic and electrical peripheral nerve stimulation (0.1\u2009Hz), timed so corticospinal potentials arrived at corticospinal-motoneuronal synapses 1.5\u2009ms before antidromic motoneuronal potentials', 'paired corticospinal-motoneuronal stimulation']","['maximal voluntary elbow flexion', 'voluntary activation', 'Maximal torque and electromyographic activity', 'Baseline median (range) maximal torque']","[{'cui': 'C0840414', 'cui_str': 'Cervical spinal cord injury'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0035168'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1762617', 'cui_str': 'Weak (qualifier value)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0031119', 'cui_str': 'Peripheral Nerves'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach (qualifier value)'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0436544', 'cui_str': 'Electrical peripheral nerve stimulation (procedure)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0039062', 'cui_str': 'Synapses'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.0859074,"Linear mixed modelling revealed no significant differences between PCMS and control protocols after conditioning (maximal torque: p = 0.87, superimposed twitch: p = 0.87, resting twitch: p = 0.44, voluntary activation: p = 0.36, biceps EMG: p = 0.25, brachioradialis EMG: 0.67).
","[{'ForeName': 'Siobhan C', 'Initials': 'SC', 'LastName': 'Dongés', 'Affiliation': 'Neuroscience Research Australia, Sydney, Australia.'}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Boswell-Ruys', 'Affiliation': 'Neuroscience Research Australia, Sydney, Australia.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Butler', 'Affiliation': 'Neuroscience Research Australia, Sydney, Australia.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'Neuroscience Research Australia, Sydney, Australia. janet.taylor@ecu.edu.au.'}]",Spinal cord,['10.1038/s41393-019-0291-3']
318,32293807,"Systematic review of the efficacy and safety of antiretroviral drugs against SARS, MERS or COVID-19: initial assessment.","INTRODUCTION


Several antiretroviral drugs are being considered for the treatment of COVID-19, the disease caused by a newly identified coronavirus, (SARS-CoV-2). We systematically reviewed the clinical outcomes of using antiretroviral drugs for the prevention and treatment of coronaviruses and planned clinical trials.
METHODS


Three databases were screened from inception to 30 March 2020 for studies reporting clinical outcomes of patients with SARS, MERS or COVID-19 treated with antiretrovirals.
RESULTS


From an initial screen of 433 titles, two randomized trials and 24 observational studies provided clinical outcome data on the use of antiretroviral drugs; most studies reported outcomes using LPV/r as treatment. Of the 21 observational studies reporting treatment outcomes, there were three studies among patients with SARS, six studies among patients with MERS and 12 studies among patients with COVID-19. In one randomized trial 99 patients with severe COVID-19 illness were randomized to receive LPV/r (400/100 mg twice a day) and 100 patients to standard of care for 14 days: LPV/r was not associated with a statistically significant difference in time to clinical improvement, although LPV/r given within 12 days of symptoms was associated with shorter time to clinical improvement; 28 day mortality was numerically lower in the LPV/r group (14/99) compared to the control group (25/100), but this difference was not statistically significant. The second trial found no benefit. The certainty of the evidence for the randomized trials was low. In the observational studies 3 out of 361 patients who received LPV/r died; the certainty of evidence was very low. Three studies reported a possible protective effect of LPV/r as post-exposure prophylaxis. Again, the certainty of the evidence was very low due to uncertainty due to limited sample size.
CONCLUSIONS


On the basis of the available evidence it is uncertain whether LPV/r and other antiretrovirals improve clinical outcomes or prevent infection among patients at high risk of acquiring COVID-19.",2020,"LPV/r was not associated with a statistically significant difference in time to clinical improvement, although LPV/r given within 12 days of symptoms was associated with shorter time to clinical improvement; 28 day mortality was numerically lower in the LPV/r group (14/99) compared to the control group (25/100), but this difference was not statistically significant.","['Three databases were screened from inception to 30 March 2020 for studies reporting clinical outcomes of patients with SARS, MERS or COVID-19 treated with antiretrovirals', '99 patients with severe COVID-19 illness', '361 patients who received LPV/r died', '100 patients to standard of care for 14\xa0days']",['LPV/r (400/100'],['shorter time to clinical improvement; 28\xa0day mortality'],"[{'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0065973', 'cui_str': 'methanol extraction residue (MER) tubercle bacillus fraction'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",[],"[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",3.0,0.147421,"LPV/r was not associated with a statistically significant difference in time to clinical improvement, although LPV/r given within 12 days of symptoms was associated with shorter time to clinical improvement; 28 day mortality was numerically lower in the LPV/r group (14/99) compared to the control group (25/100), but this difference was not statistically significant.","[{'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Ford', 'Affiliation': 'Department of HIV, Hepatitis and Sexually Transmitted Infections, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Vitoria', 'Affiliation': 'Department of HIV, Hepatitis and Sexually Transmitted Infections, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Rangaraj', 'Affiliation': 'Department of HIV, Hepatitis and Sexually Transmitted Infections, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Norris', 'Affiliation': 'Science Division, Quality of Norms and Standards Department, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Calmy', 'Affiliation': 'HIV/AIDS Unit, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Doherty', 'Affiliation': 'Department of HIV, Hepatitis and Sexually Transmitted Infections, World Health Organization, Geneva, Switzerland.'}]",Journal of the International AIDS Society,['10.1002/jia2.25489']
319,31802733,Comparison of School-Based and Community-Wide Mass Drug Administration for Schistosomiasis Control in an Area of Western Kenya with High Initial  Schistosoma mansoni  Infection Prevalence: A Cluster Randomized Trial.,"We conducted a cluster randomized trial comparing the target population and timing of mass drug administration (MDA) with praziquantel for control of schistosomiasis in villages in western Kenya with high initial prevalence (> 25%) according to a harmonized protocol developed by the Schistosomiasis Consortium for Operational Research and Evaluation. A total of 150 villages were randomized into six treatment arms (25 villages per arm), were assessed at baseline, and received two or four rounds of MDA using community-wide (CWT) or school-based (SBT) treatment over 4 years. In the fifth year, a final evaluation was conducted. The primary outcomes were prevalence and intensity of  Schistosoma mansoni  infections in children aged 9-12 years, each year their village received MDA. Baseline and year 5 assessments of first-year students and adults were also performed. Using Poisson and negative binomial regression with generalized estimating equations, we found similar effects of CWT and SBT MDA treatment strategies in children aged 9-12 years: significant reductions of prevalence of infection in all arms and of heavy-intensity (≥ 400 eggs/gram) infections in most arms but no significant differences between arms. Combined arms of villages that received four rounds of treatment had greater reduction than villages in arms that only received two rounds of treatment. Surprisingly, we also found benefits of SBT for first-year primary students and adults, who never received treatment in those arms. Our data support the use of annual SBT for control programs when coupled with attention to infections in younger children and occasional treatment of adults.",2020,"Using Poisson and negative binomial regression with generalized estimating equations, we found similar effects of CWT and SBT MDA treatment strategies in children aged 9-12 years: significant reductions of prevalence of infection in all arms and of heavy-intensity (≥ 400 eggs/gram) infections in most arms but no significant differences between arms.","['children aged 9-12 years', 'control of schistosomiasis in villages in western Kenya with high initial prevalence (> 25%) according to a harmonized protocol developed by the Schistosomiasis Consortium for Operational Research and Evaluation', 'Schistosomiasis Control in an Area of Western Kenya with High Initial  Schistosoma mansoni', 'A total of 150 villages', 'younger children and occasional treatment of adults']","['CWT and SBT MDA', 'mass drug administration (MDA) with praziquantel', 'SBT', 'MDA using community-wide (CWT) or school-based (SBT) treatment', 'School-Based and Community-Wide Mass Drug Administration']","['Infection Prevalence', 'prevalence and intensity of  Schistosoma mansoni  infections', 'prevalence of infection']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036323', 'cui_str': 'Schistoma Infection'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0036319', 'cui_str': 'Schistosoma mansoni'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0521114', 'cui_str': 'Infrequent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C4505223', 'cui_str': 'Mass Drug Administration'}, {'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0036330', 'cui_str': 'Schistosoma mansoni Infection'}]",,0.0890586,"Using Poisson and negative binomial regression with generalized estimating equations, we found similar effects of CWT and SBT MDA treatment strategies in children aged 9-12 years: significant reductions of prevalence of infection in all arms and of heavy-intensity (≥ 400 eggs/gram) infections in most arms but no significant differences between arms.","[{'ForeName': 'W Evan', 'Initials': 'WE', 'LastName': 'Secor', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Wiegand', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Susan P', 'Initials': 'SP', 'LastName': 'Montgomery', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Diana M S', 'Initials': 'DMS', 'LastName': 'Karanja', 'Affiliation': 'Center for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Maurice R', 'Initials': 'MR', 'LastName': 'Odiere', 'Affiliation': 'Center for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0626']
320,31806653,"Within-Trial Evaluation of Medical Resources, Costs, and Quality of Life Among Patients With Type 2 Diabetes Participating in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).","OBJECTIVE


To compare medical resource use, costs, and health utilities for 14,752 patients with type 2 diabetes who were randomized to once-weekly exenatide (EQW) or placebo in addition to usual diabetes care in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).
RESEARCH DESIGN AND METHODS


Medical resource use data and responses to the EuroQol 5-Dimension (EQ-5D) instrument were collected at baseline and throughout the trial. Medical resources and medications were assigned values by using U.S. Medicare payments and wholesale acquisition costs, respectively. Secondary analyses used English costs.
RESULTS


Patients were followed for an average of 3.3 years, during which time those randomized to EQW experienced 0.41 fewer inpatient days (7.05 vs. 7.46 days; relative rate ratio 0.91;  P  = 0.05). Rates of outpatient medical visits were similar, as were total inpatient and outpatient costs. Mean costs for nonstudy diabetes medications over the study period were ∼$1,600 lower with EQW than with placebo ( P  = 0.01). Total within-study costs, excluding study medication, were lower in the EQW arm than in the placebo arm ($28,907 vs. $30,914;  P  ≤ 0.01). When including the estimated cost of EQW, total mean costs were significantly higher in the EQW group than in the placebo group ($42,697 vs. $30,914;  P  < 0.01). With English costs applied, mean total costs, including exenatide costs, were £1,670 higher in the EQW group than the placebo group (£10,874 vs. £9,204;  P  < 0.01). There were no significant differences in EQ-5D health utilities between arms over time.
CONCLUSIONS


Medical costs were lower in the EQW arm than the placebo arm, but total costs were significantly higher once the cost of branded exenatide was incorporated.",2020,"There were no significant differences in EQ-5D health utilities between arms over time.
","['14,752 patients with type 2 diabetes', 'Patients With Type 2 Diabetes Participating in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL']","['placebo', 'EQW', 'exenatide (EQW) or placebo']","['Rates of outpatient medical visits', 'English costs', 'estimated cost of EQW, total mean costs', 'total costs', 'Mean costs for nonstudy diabetes medications', 'Costs, and Quality of Life', 'EQ-5D health utilities', 'mean total costs, including exenatide costs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}]","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}]",1670.0,0.094758,"There were no significant differences in EQ-5D health utilities between arms over time.
","[{'ForeName': 'Shelby D', 'Initials': 'SD', 'LastName': 'Reed', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC shelby.reed@duke.edu.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Dakin', 'Affiliation': 'Oxford Health Economic Research Centre, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Frauke', 'Initials': 'F', 'LastName': 'Becker', 'Affiliation': 'Oxford Health Economic Research Centre, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Leal', 'Affiliation': 'Oxford Health Economic Research Centre, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Gustavson', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD.'}, {'ForeName': 'Bernt', 'Initials': 'B', 'LastName': 'Kartman', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Wittbrodt', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Neha J', 'Initials': 'NJ', 'LastName': 'Pagidipati', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'M Angelyn', 'Initials': 'MA', 'LastName': 'Bethel', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Alastair M', 'Initials': 'AM', 'LastName': 'Gray', 'Affiliation': 'Oxford Health Economic Research Centre, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0950']
321,32315696,Testing the effects of transcranial direct current stimulation (tDCS) on the face inversion effect and the N170 event-related potentials (ERPs) component.,"The following study investigates the effects of tDCS on face recognition skills indexed by the face inversion effect (better recognition performance for upright vs. inverted faces). We combined tDCS and EEG simultaneously to examine the effects of tDCS on the face inversion effect behaviourally and on the N170 ERPs component. The results from two experiments (overall N = 112) show that anodal tDCS delivered at Fp3 site for 10 min at 1.5 mA (double-blind and between-subjects) can reduce behaviourally the face inversion effect compared to sham (control) stimulation. The ERP results provide some evidence for tDCS being able to influence the face inversion effect on the N170. Specifically, we find a dissociation of the tDCS-induced effects where for the N170 latencies the tDCS reduces the usual face inversion effect (delayed N170 in response to inverted vs. upright faces) compared to sham. Contrarily, the same tDCS procedure on the same participants increased the inversion effect seen in the N170 amplitudes by making the negative deflection for the inverted faces that much greater than that for upright faces. We interpret our results in the context of the literature on the face inversion effect and the N170 peak component. In doing so, we extend our results to previous studies investigating the effects of tDCS on perceptual learning and face recognition.",2020,The following study investigates the effects of tDCS on face recognition skills indexed by the face inversion effect (better recognition performance for upright vs. inverted faces).,[],"['tDCS', 'transcranial direct current stimulation (tDCS', 'anodal tDCS']",['perceptual learning and face recognition'],[],"[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]",,0.0243991,The following study investigates the effects of tDCS on face recognition skills indexed by the face inversion effect (better recognition performance for upright vs. inverted faces).,"[{'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Civile', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK. Electronic address: c.civile@exeter.ac.uk.'}, {'ForeName': 'Emika', 'Initials': 'E', 'LastName': 'Waguri', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Quaglia', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Wooster', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Curtis', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Rossy', 'Initials': 'R', 'LastName': 'McLaren', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Aureliu', 'Initials': 'A', 'LastName': 'Lavric', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'I P L', 'Initials': 'IPL', 'LastName': 'McLaren', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK. Electronic address: i.p.l.mclaren@exeter.ac.uk.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107470']
322,30997482,Sex-Related Differences in Brain Volumes and Cerebral Blood Flow Among Overweight and Obese Adults With Type 2 Diabetes: Exploratory Analyses From the Action for Health in Diabetes Brain Magnetic Resonance Imaging Study.,"BACKGROUND


Sex may be an important modifier of brain health in response to risk factors. We compared brain structure and function of older overweight and obese women and men with type 2 diabetes mellitus.
METHODS


Cross-sectional cognitive assessments and magnetic resonance images were obtained in 224 women and 95 men (mean age 69 years) with histories of type 2 diabetes mellitus and overweight or obesity. Prior to magnetic resonance images, participants had completed an average of 10 years of random assignment to either multidomain intervention targeting weight loss or a control condition of diabetes support and education. Total (summed gray and white) matter volumes, white matter hyperintensity volumes, and cerebral blood flow across five brain regions of interest were analyzed using mixed-effects models.
RESULTS


After covariate adjustment, women, compared with men, averaged 10.9 [95% confidence interval 3.3, 18.5; ≈1%] cc greater summed region of interest volumes and 1.39 [0.00002, 2.78; ≈54%] cc greater summed white matter hyperintensity volumes. Sex differences could not be attributed to risk factor profiles or intervention response. Their magnitude did not vary significantly with respect to age, body mass index, intervention assignment, or APOE-ε4 genotype. Sex differences in brain magnetic resonance images outcomes did not account for the better levels of cognitive functioning in women than men.
CONCLUSIONS


In a large cohort of older overweight or obese adults with type 2 diabetes mellitus, differences in brain volumes and white matter disease were apparent between women and men, but these did not account for a lower prevalence of cognitive impairment in women compared with men in this cohort.
TRIAL REGISTRATION


NCT00017953.",2020,"Their magnitude did not vary significantly with respect to age, body mass index, intervention assignment, or APOE-ε4 genotype.","['participants had completed an average of 10 years of random assignment to either multidomain intervention targeting weight loss or a control condition of diabetes support and education', 'older overweight and obese women and men with type 2 diabetes mellitus', 'women than men', '224 women and 95 men (mean age 69 years) with histories of type 2 diabetes mellitus and overweight or obesity', 'Overweight and Obese Adults With Type 2 Diabetes', 'older overweight or obese adults with type 2 diabetes mellitus']",[],"['Brain Volumes and Cerebral Blood Flow', 'cognitive functioning', 'brain volumes and white matter disease', 'Total (summed gray and white) matter volumes, white matter hyperintensity volumes, and cerebral blood flow across five brain regions of interest']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C1272247', 'cui_str': 'Target weight'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0270612', 'cui_str': 'White Matter Diseases'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1269776', 'cui_str': 'Gray'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0682708'}, {'cui': 'C1273723', 'cui_str': 'Brain region'}]",224.0,0.0891676,"Their magnitude did not vary significantly with respect to age, body mass index, intervention assignment, or APOE-ε4 genotype.","[{'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Department of Biostatistics and Data Science, Winston-Salem, NC.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Hayden', 'Affiliation': 'Department of Social Sciences and Health Policy, Winston-Salem, NC.'}, {'ForeName': 'Samuel N', 'Initials': 'SN', 'LastName': 'Lockhart', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Hussein N', 'Initials': 'HN', 'LastName': 'Yassine', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California. Los Angeles, CA.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Hoscheidt', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Sevil', 'Initials': 'S', 'LastName': 'Yasar', 'Affiliation': 'Department of Medicine, Johns Hopkins School of Medicine, Baltimore, MD.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Luchsinger', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Neiberg', 'Affiliation': 'Department of Biostatistics and Data Science, Winston-Salem, NC.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Diaz Brinton', 'Affiliation': 'University of Arizona Center for Innovation in Brain Science, The University of Arizona Health Sciences, Tucson, AZ.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Carmichael', 'Affiliation': 'Biomedical Imaging Center, Pennington Biomedical Research Center, Baton Rouge, LA.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz090']
323,32316870,Cycling-based repeat sprint training in the heat enhances running performance in team sport players.,"Applying heat training interventions in a team sports setting remains challenging. This study investigated the effects of integrating short-term, repeat sprint heat training with passive heat exposure on running performance and general conditioning in team sport players. Thirty male club-level Australian Football players were assigned randomly to: Passive + Active Heat (PAH;  n  = 10), Active Heat (AH;  n  = 10) or Control (CON;  n  = 10) to complete 6 × 40 min high-intensity cycling training sessions over 12 days in 35°C (PAH and AH) or 18°C (CON), 50% RH in parallel with mid-season sports-specific training and games. Players in PAH were exposed to 20 min pre-exercise passive heat. Physiological adaptation and running capacity were assessed via a treadmill submaximal heat stress test followed by a time-to-exhaustion run in 35°C, 50% RH. Running capacity increased by 26% ± 8% PAH (0.88, ±0.23; standardised mean, ± 90% confidence limits), 29% ± 12% AH (1.23, ±0.45) and 10% ± 11% CON (0.45, ±0.48) compared with baseline. Both PAH (0.52, ±0.42; standardised mean, ± 90% confidence limits) and AH (0.35, ±0.57) conditions yielded a greater improvement in running capacity than CON. Physiological and perceptual measures remained relatively unchanged between baseline and post-intervention heat stress tests, within and between conditions. When thermal adaptation is not a direct priority, short-term, repeat effort high-intensity cycling in hot conditions combined with sports-specific training can further enhance running performance in team sport players. Six heat exposures across 12-days should improve running performance while minimising lower limb load and cumulative fatigue for team sports players. Highlights  Short-duration high-intensity intermittent heat training can be successfully integrated with sport-specific training during the competitive season.When acquiring heat acclimation is not a direct priority, heat-based training offers a practical and time efficient method for enhancing aerobic conditioning in team sport players.In state-level team sport players, the perceived benefits of engaging heat training may complement increases in training load and possibly underlying thermal/physiological adaptations.Implementing a running-based performance trial either side of cycling-based heat training can evaluate the degree of transfer into a sports-specific environment.",2020,"Running capacity increased by 26 ± 8% PAH (0.88, ±0.23; standardised mean, ± 90% confidence limits), 29 ± 12% AH (1.23, ±0.45) and 10 ± 11% CON (0.45, ±0.48) compared with baseline.","['Thirty male club-level Australian Football players', 'team sport players']","['Passive\u2009+\u2009Active Heat (PAH; n=10), Active Heat (AH; n=10) or Control (CON; n=10) to complete 6\u2009×\u200940\u2005min high-intensity cycling training sessions over 12 days in 35°C (PAH and AH) or 18°C (CON), 50% RH in parallel with mid-season sports-specific training and games', 'heat training interventions', 'Cycling-based repeat sprint training', 'integrating short-term, repeat sprint heat training with passive heat exposure']","['Physiological and perceptual measures', 'running capacity', 'Running capacity', 'Physiological adaptation and running capacity']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0038039', 'cui_str': 'Sport'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0454374', 'cui_str': 'Sprint training'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0239930', 'cui_str': 'Heat exposure'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0001400', 'cui_str': 'Adaptations, Physiological'}, {'cui': 'C0035953', 'cui_str': 'Running'}]",30.0,0.0436445,"Running capacity increased by 26 ± 8% PAH (0.88, ±0.23; standardised mean, ± 90% confidence limits), 29 ± 12% AH (1.23, ±0.45) and 10 ± 11% CON (0.45, ±0.48) compared with baseline.","[{'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Gale', 'Affiliation': 'University of Canberra Research Institute for Sport and Exercise, University of Canberra, Bruce, Australia.'}, {'ForeName': 'Naroa', 'Initials': 'N', 'LastName': 'Etxebarria', 'Affiliation': 'University of Canberra Research Institute for Sport and Exercise, University of Canberra, Bruce, Australia.'}, {'ForeName': 'Kate L', 'Initials': 'KL', 'LastName': 'Pumpa', 'Affiliation': 'University of Canberra Research Institute for Sport and Exercise, University of Canberra, Bruce, Australia.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Pyne', 'Affiliation': 'University of Canberra Research Institute for Sport and Exercise, University of Canberra, Bruce, Australia.'}]",European journal of sport science,['10.1080/17461391.2020.1759696']
324,32316014,Controlling Blood Pressure Under Transcranial Doppler Guidance after Endovascular Treatment in Patients with Acute Ischemic Stroke.,"OBJECTIVE


This study aimed to control blood pressure (BP) under transcranial Doppler (TCD) guidance in patients with anterior circulation acute ischemic stroke after endovascular treatment (EVT) to reduce the incidence of early neurological deterioration (END) and improve neurological prognosis.
METHODS


This prospective randomized controlled study included 95 patients who were randomly divided into a TCD-guided BP control (TBC) group and a non-TCD-guided BP control (NBC) group. The patients were monitored by TCD within 72 h after EVT. In the TBC group, BP decreased, BP increased, or intracranial pressure decreased when TCD showed blood flow acceleration, deceleration, or intracranial hypertension respectively. The BP of the NBC group was controlled according to the guidelines. The incidence of END and the prognosis was compared between the 2 groups.
RESULTS


TCD identified 18 patients with blood flow acceleration, but the prognosis of the 2 groups was not significantly different. TCD identified 23 patients with blood flow deceleration, and the poor prognosis rate at discharge was lower in the TBC group than in the NBC group (45.5 vs. 91.7%, p = 0.027). TCD identified 34 patients with intracranial hypertension, and the 3-month mortality rate of the TBC group was lower than that of the NBC group (0 vs. 36.8%, p = 0.011). The incidence rates of END and 3-month mortality in the TBC group were lower than those in the NBC group (13.8 vs. 37.5%, p = 0.036; 0 vs. 25.0%, p = 0.012) when TCD parameters were abnormal. Multivariable logistic regression analysis showed that the TBC group (adjusted OR 0.267, 95% CI 0.074-0.955; p = 0.042) was an independent protective factor against the incidence of END when TCD parameters were abnormal.
CONCLUSION


These findings indicated that TCD-guided BP and intracranial pressure control improved the prognosis of patients with blood flow deceleration and intracranial hypertension.",2020,"The incidence rates of END and 3-month mortality in the TBC group were lower than those in the NBC group (13.8 vs. 37.5%, p = 0.036; 0 vs. 25.0%, p = 0.012) when TCD parameters were abnormal.","['34 patients with intracranial hypertension', '95 patients who were randomly divided into a', 'patients with anterior circulation acute ischemic stroke after endovascular treatment (EVT', 'Patients with Acute Ischemic Stroke']","['control blood pressure (BP) under transcranial Doppler (TCD) guidance', 'NBC', 'TCD', 'TCD-guided BP and intracranial pressure control', 'TCD-guided BP control (TBC) group and a non-TCD-guided BP control (NBC']","['3-month mortality rate', 'BP increased, or intracranial pressure', 'blood flow deceleration', 'poor prognosis rate at discharge', 'incidence rates of END and 3-month mortality', 'blood flow acceleration, deceleration, or intracranial hypertension', 'blood flow acceleration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151740', 'cui_str': 'Raised intracranial pressure'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0206077', 'cui_str': 'Transcranial doppler ultrasonography'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0007928', 'cui_str': 'Chad'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0497247', 'cui_str': 'Elevated blood pressure'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0011100', 'cui_str': 'Deceleration'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0151740', 'cui_str': 'Raised intracranial pressure'}]",95.0,0.0190262,"The incidence rates of END and 3-month mortality in the TBC group were lower than those in the NBC group (13.8 vs. 37.5%, p = 0.036; 0 vs. 25.0%, p = 0.012) when TCD parameters were abnormal.","[{'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China, suyingying@xwh.ccmu.edu.cn.'}, {'ForeName': 'Yanbo', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yingbo', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yijia', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhongyun', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}]","Cerebrovascular diseases (Basel, Switzerland)",['10.1159/000506855']
325,32317292,"Results of a randomized, double-blind phase II clinical trial of NY-ESO-1 vaccine with ISCOMATRIX adjuvant versus ISCOMATRIX alone in participants with high-risk resected melanoma.","BACKGROUND


To compare the clinical efficacy of New York Esophageal squamous cell carcinoma-1 (NY-ESO-1) vaccine with ISCOMATRIX adjuvant versus ISCOMATRIX alone in a randomized, double-blind phase II study in participants with fully resected melanoma at high risk of recurrence.
METHODS


Participants with resected stage IIc, IIIb, IIIc and IV melanoma expressing NY-ESO-1 were randomized to treatment with three doses of NY-ESO-1/ISCOMATRIX or ISCOMATRIX adjuvant administered intramuscularly at 4-week intervals, followed by a further dose at 6 months. Primary endpoint was the proportion free of relapse at 18 months in the intention-to-treat (ITT) population and two per-protocol populations. Secondary endpoints included relapse-free survival (RFS) and overall survival (OS), safety and NY-ESO-1 immunity.
RESULTS


The ITT population comprised 110 participants, with 56 randomized to NY-ESO-1/ISCOMATRIX and 54 to ISCOMATRIX alone. No significant toxicities were observed. There were no differences between the study arms in relapses at 18 months or for median time to relapse; 139 vs 176 days (p=0.296), or relapse rate, 27 (48.2%) vs 26 (48.1%) (HR 0.913; 95% CI 0.402 to 2.231), respectively. RFS and OS were similar between the study arms. Vaccine recipients developed strong positive antibody responses to NY-ESO-1 (p≤0.0001) and NY-ESO-1-specific CD4 +  and CD8 +  responses. Biopsies following relapse did not demonstrate differences in NY-ESO-1 expression between the study populations although an exploratory study demonstrated reduced (NY-ESO-1) + /Human Leukocyte Antigen (HLA) class I +  double-positive cells in biopsies from vaccine recipients performed on relapse in 19 participants.
CONCLUSIONS


The vaccine was well tolerated, however, despite inducing antigen-specific immunity, it did not affect survival endpoints. Immune escape through the downregulation of NY-ESO-1 and/or HLA class I molecules on tumor may have contributed to relapse.",2020,Vaccine recipients developed strong positive antibody responses to NY-ESO-1 (p≤0.0001) and NY-ESO-1-specific CD4 +  and CD8 +  responses.,"['participants with fully resected melanoma at high risk of recurrence', 'Participants with resected stage IIc, IIIb, IIIc and IV melanoma expressing NY-ESO-1', 'participants with high-risk resected melanoma', 'biopsies from vaccine recipients performed on relapse in 19 participants']","['NY-ESO-1 vaccine with ISCOMATRIX adjuvant versus ISCOMATRIX alone', 'HLA class', 'Vaccine', 'New York Esophageal squamous cell carcinoma-1 (NY-ESO-1) vaccine with ISCOMATRIX adjuvant versus ISCOMATRIX alone']","['relapse rate', 'toxicities', 'strong positive antibody responses', 'median time to relapse', 'proportion free of relapse', 'relapse-free survival (RFS) and overall survival (OS), safety and NY-ESO-1 immunity', 'RFS and OS', 'Leukocyte Antigen (HLA) class']","[{'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0441770', 'cui_str': 'Stage 2C'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0536940', 'cui_str': 'CTAG1 protein, human'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]","[{'cui': 'C0536940', 'cui_str': 'CTAG1 protein, human'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1529741', 'cui_str': 'ISCOMATRIX'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0741132', 'cui_str': 'Antibody test positive'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0536940', 'cui_str': 'CTAG1 protein, human'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0019721', 'cui_str': 'HLA antigen'}, {'cui': 'C0456387', 'cui_str': 'Class'}]",,0.62737,Vaccine recipients developed strong positive antibody responses to NY-ESO-1 (p≤0.0001) and NY-ESO-1-specific CD4 +  and CD8 +  responses.,"[{'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Cebon', 'Affiliation': 'Cancer Immunobiology Programme, Olivia Newton-John Cancer Research Institute, School of Cancer Medicine, La Trobe University at Austin Health, Heidelberg, Victoria, Australia j.cebon@onjcri.org.au.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gore', 'Affiliation': 'Oncology, Royal Marsden Hospital NHS Trust, London, UK.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Thompson', 'Affiliation': 'Melanoma Institute Australia, North Sydney, New South Wales, Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Davis', 'Affiliation': 'Ludwig Institute for Cancer Research Austin Branch, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Grant A', 'Initials': 'GA', 'LastName': 'McArthur', 'Affiliation': 'Melanona and Skin Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Euan', 'Initials': 'E', 'LastName': 'Walpole', 'Affiliation': 'Cancer Services Division, Princess Alexandra Hospital Health Service District, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Smithers', 'Affiliation': 'Oncology Services Unit, Princess Alexandra Hospital Health Service District, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Cerundolo', 'Affiliation': 'MRC Human Immunology Unit, Weatherall Institute of Molecular Medicine, John Radcliffe Hospital, Oxford, Oxfordshire, UK.'}, {'ForeName': 'P Rod', 'Initials': 'PR', 'LastName': 'Dunbar', 'Affiliation': 'School of Biological Sciences and Maurice Wilkins Centre, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'MacGregor', 'Affiliation': 'Department of Anatomical Pathology, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Fisher', 'Affiliation': 'Oncology, Royal Marsden Hospital NHS Trust, London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Millward', 'Affiliation': 'School of Medicine and Pharmacology, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Nathan', 'Affiliation': 'Mount Vernon Cancer Centre, Mount Vernon Hospital, Northwood, London, UK.'}, {'ForeName': 'Michael P N', 'Initials': 'MPN', 'LastName': 'Findlay', 'Affiliation': 'School of Medicine and Health Science, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hersey', 'Affiliation': 'Melanoma Immunology and Oncology Group, Centenary Institute, Newtown, New South Wales, Australia.'}, {'ForeName': 'T R Jeffry', 'Initials': 'TRJ', 'LastName': 'Evans', 'Affiliation': 'Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Christian Hermann', 'Initials': 'CH', 'LastName': 'Ottensmeier', 'Affiliation': 'School of Cancer Sciences, University of Southampton Faculty of Medicine, Southampton, Hampshire, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Marsden', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Angus G', 'Initials': 'AG', 'LastName': 'Dalgleish', 'Affiliation': 'Cell and Molecular Sciences, Division of Oncology, St Georges Hospital Medical School, London, UK.'}, {'ForeName': 'Pippa G', 'Initials': 'PG', 'LastName': 'Corrie', 'Affiliation': ""West Anglia Cancer Research Network Oncology Centre, Addenbrooke's Hospital, Cambridge, Cambridgeshire, UK.""}, {'ForeName': 'Marples', 'Initials': 'M', 'LastName': 'Maria', 'Affiliation': 'The Cancer Research Centre, Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Brimble', 'Affiliation': 'School of Biological Sciences and Maurice Wilkins Centre, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Geoff', 'Initials': 'G', 'LastName': 'Williams', 'Affiliation': 'School of Biological Sciences and Maurice Wilkins Centre, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Sintia', 'Initials': 'S', 'LastName': 'Winkler', 'Affiliation': 'School of Biological Sciences and Maurice Wilkins Centre, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Jackson', 'Affiliation': 'Ludwig Institute for Cancer Research Austin Branch, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Endo-Munoz', 'Affiliation': 'Cancer Immunobiology Programme, Olivia Newton-John Cancer Research Institute, School of Cancer Medicine, La Trobe University at Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Candani S A', 'Initials': 'CSA', 'LastName': 'Tutuka', 'Affiliation': 'Cancer Immunobiology Programme, Olivia Newton-John Cancer Research Institute, School of Cancer Medicine, La Trobe University at Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Venhaus', 'Affiliation': 'Ludwig Institute for Cancer Research, New York, New York, USA.'}, {'ForeName': 'Lloyd J', 'Initials': 'LJ', 'LastName': 'Old', 'Affiliation': 'Ludwig Institute for Cancer Research, New York, New York, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Haack', 'Affiliation': 'Versagenics Inc, Morrisville, North Carolina, USA.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Maraskovsky', 'Affiliation': 'CSL Limited, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Behren', 'Affiliation': 'Cancer Immunobiology Programme, Olivia Newton-John Cancer Research Institute, School of Cancer Medicine, La Trobe University at Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Weisan', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Ludwig Institute for Cancer Research Austin Branch, Heidelberg, Victoria, Australia.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2019-000410']
326,32310966,"Implementer and recipient perspectives of community-wide mass drug administration for soil-transmitted helminths in Kwale County, Kenya.","Soil-transmitted helminthiases (STH) are one of 17 neglected tropical diseases (NTDs) earmarked for control or elimination by 2020 in the WHO's Roadmap on NTDs. Deworming programs for STH have thus far been focused on treating pre-school and school-aged children; however, there is a growing consensus that to achieve elimination of STH transmission, programs must also target adults, potentially through community-wide mass drug administration (MDA). There is currently a gap in the literature on what components are required to deliver community-wide MDA for STH in order to achieve high intervention reach and uptake. Nested within the TUMIKIA Project, a cluster randomized trial in Kenya evaluating the effectiveness of school-based deworming versus community-wide MDA, we collected qualitative data from program implementers and recipients in eight clusters where community-wide MDA was delivered. Data collection included semi-structured in-depth interviews (n = 72) and focus group discussions (n = 32). A conceptual framework for drug distribution was constructed to help build an analysis codebook. Case memos were developed for each top-level theme. Community-wide MDA for STH was perceived as a complex intervention with key administrative and social mobilization domains. Key actionable themes included: (1) developing an efficient strategy to allocate reasonable workload for implementers to cover all targeted households; (2) maximizing community drug distributors' motivation through promoting belief in the effectiveness of the intervention and providing sufficient financial incentives; (3) developing effective capacity building strategies for implementers; and (4) implementing a context-adapted community engagement strategy that leverages existing community structures and takes into consideration past community experiences of MDAs. Transitioning from STH control to elimination goals requires significant planning and action to ensure community-wide MDA is delivered with sufficient reach and uptake. We present findings that can inform national deworming programs to increase intervention delivery capacity.",2020,"Nested within the TUMIKIA Project, a cluster randomized trial in Kenya evaluating the effectiveness of school-based deworming versus community-wide MDA, we collected qualitative data from program implementers and recipients in eight clusters where community-wide MDA was delivered.","['soil-transmitted helminths in Kwale County, Kenya']","['intervention and providing sufficient financial incentives; (3) developing effective capacity building strategies for implementers; and (4) implementing a context-adapted community engagement strategy that leverages existing community structures', 'Soil-transmitted helminthiases (STH', 'school-based deworming versus community-wide MDA']",[],"[{'cui': 'C0037592', 'cui_str': 'Soil'}, {'cui': 'C0242781', 'cui_str': 'Communicable Disease Transmission'}, {'cui': 'C0018893', 'cui_str': 'Helminth'}, {'cui': 'C0445519', 'cui_str': 'Kwale'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2718026', 'cui_str': 'Capacity Building'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0037592', 'cui_str': 'Soil'}, {'cui': 'C0242781', 'cui_str': 'Communicable Disease Transmission'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199859', 'cui_str': 'Deworming'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}]",[],,0.0260652,"Nested within the TUMIKIA Project, a cluster randomized trial in Kenya evaluating the effectiveness of school-based deworming versus community-wide MDA, we collected qualitative data from program implementers and recipients in eight clusters where community-wide MDA was delivered.","[{'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Legge', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Kepha', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Mateo', 'Initials': 'M', 'LastName': 'Prochazka', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Halliday', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Pullan', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Marie-Claire', 'Initials': 'MC', 'LastName': 'Gwayi-Chore', 'Affiliation': 'Department of Global Health, University of Washington, School of Public Health, Seattle, Washington, United States of America.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Njomo', 'Affiliation': 'Eastern and Southern Africa Centre of International Parasite Control, Kenya Medical Research Institute, Nairobi, Kenya.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008258']
327,32314828,HCC recurrence in HCV-infected patients after liver transplantation: SiLVER Study reveals benefits of sirolimus in combination with CNIs - a post-hoc analysis.,"Factors affecting outcomes in liver transplant (LTx) recipients with hepatocellular carcinoma (HCC) and hepatitis C viral (HCV) infection include the choice of immunosuppression. Here, we analyzed the HCV +  subgroup of patients from the randomized controlled, international SiLVER Study. We performed a post hoc analysis of 166 HCV +  SiLVER Study patients regarding HCC outcome after LTx. Control patients (group A: n = 88) received mTOR inhibitor (mTORi)-free, calcineurin inhibitor (CNI)-based versus sirolimus-based immunosuppression (group B: n = 78). We found no significant difference regarding HCV-RNA titers between group A and B. Since no effect in group B could be due to variable sirolimus dosing, we split group B into patients receiving sirolimus-based immunosuppression + CNIs for >50% (B1; n = 44) or <50% (B2; n = 34) of the time. While there remained no difference in HCV-RNA titer between groups, HCC recurrence-free survival in group B1 (81.8%) was markedly better versus both group A (62.7%; P = 0.0136) and group B2 (64.7%; P = 0.0326); Interestingly, further subgroup analysis revealed an increase (P = 0.0012) in liver enzyme values in group B2. Taken together, in HCV-infected patients with HCC and LTx, mTORi immunosuppression + CNIs yields excellent outcomes. Unexpectedly, higher levels of liver inflammation and poorer outcomes occur with mTORi monotherapy in the HCV +  subgroup.",2020,"While there remained no difference in HCV-RNA titer between groups, HCC recurrence-free survival in group B1 (81.8%) was markedly better versus both group A (62.7%; P=0.0136) and group B2 (64.7%; P=0.0326); Interestingly, further subgroup analysis revealed an increase (P=0.0012) in liver-enzyme values in group B2.
","['Control patients (group A: n=88) received', 'liver transplant (LTx) recipients with hepatocellular carcinoma (HCC) and hepatitis C viral (HCV) infection', 'HCV patients after liver transplantation', '166 HCV +  SiLVER Study patients regarding HCC outcome after LTx']","['sirolimus-based immunosuppression + CNIs', 'sirolimus', 'mTOR inhibitor (mTORi)-free, calcineurin inhibitor (CNI)-based versus sirolimus-based immunosuppression']","['liver inflammation', 'HCV-RNA titer', 'liver-enzyme values', 'HCV-RNA titers', 'HCC recurrence', 'HCC recurrence-free survival']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0455647', 'cui_str': 'H/O: liver recipient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0037125', 'cui_str': 'silver'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}]","[{'cui': 'C0019158', 'cui_str': 'Inflammatory disease of liver'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}]",,0.0596776,"While there remained no difference in HCV-RNA titer between groups, HCC recurrence-free survival in group B1 (81.8%) was markedly better versus both group A (62.7%; P=0.0136) and group B2 (64.7%; P=0.0326); Interestingly, further subgroup analysis revealed an increase (P=0.0012) in liver-enzyme values in group B2.
","[{'ForeName': 'Jens M', 'Initials': 'JM', 'LastName': 'Werner', 'Affiliation': 'Department of Surgery, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hornung', 'Affiliation': 'Department of Surgery, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Rubertha', 'Initials': 'R', 'LastName': 'Krah', 'Affiliation': 'Department of Surgery, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Götz', 'Affiliation': 'Department of Surgery, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Andreas A', 'Initials': 'AA', 'LastName': 'Schnitzbauer', 'Affiliation': 'Department of Surgery, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Schlitt', 'Affiliation': 'Department of Surgery, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Geissler', 'Affiliation': 'Department of Surgery, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Transplant international : official journal of the European Society for Organ Transplantation,['10.1111/tri.13621']
328,32310686,MAP Train My Brain: Meditation Combined with Aerobic Exercise Reduces Stress and Rumination While Enhancing Quality of Life in Medical Students.,"Medical students must commit a great deal of concentration and energy during their first 2 years of study, leaving minimal time for self-care. However, once they become physicians, they are in the position of instructing their patients to engage in self-care.  Objectives:  In this study, first- and second-year medical students participated in a combined mental and physical (MAP) training program with meditation and aerobic exercise that targeted brain health. *   Design:  Each weekly session began with 30 min of instructional training that emphasized the benefit of the program for brain and body health, followed by 30 min of silent meditation, and ending with 30 min of aerobic exercise. Participants monitored their heart rate to achieve 60%-80% of their personal maximum. Participants engaged in one additional session of MAP training each week on their own.  Location and Subjects:  First- and second-year medical students were recruited to be participants from the Robert Wood Johnson Medical School (RWJMS) in Piscataway, NJ.  Outcome measures:  Participants completed questionnaires of depressive symptoms, perceived stress, ruminative thoughts, and quality of life, before and after the training approximately 8-9 weeks apart.  Results:  After 8 weeks of training and in contrast to students who did not participate (n = 30), the medical students who completed at least 14 sessions out of 16 (n = 17) reported significantly fewer ruminations (-17%), including depressive (-16%) and brooding ruminations (-24%). Ruminations are repetitive thoughts that are typically negative in nature and associated with symptoms of depression. The medical students also reported greater quality of life at the end of training and less perceived stress. The majority (84%) would recommend these types of practices and this one in particular to their future patients.  Conclusions:  Previous studies have demonstrated that MAP training can reduce symptoms of depression as well as trauma-related cognitions, while increasing oxygen consumption and synchronized brain activity during cognitive control procedures. Overall, MAP training offers a time-efficient and evidence-based means of maintaining mental and physical wellness for students during medical school and into their future, as well as their patients alike.",2020,"After 8 weeks of training and in contrast to students who did not participate, the medical students reported significantly fewer ruminations (-17%), including depressive (-16%) and brooding ruminations (-24%).","['patients with major depressive disorder', 'Medical Students', 'Sixty-one first- and second-year medical students were recruited to be participants from the Robert Wood Johnson Medical School (RWJMS) in Piscataway, NJ']","['MAP training', 'combined mental and physical (MAP) training program with meditation and aerobic exercise that targeted brain health', 'Aerobic Exercise', 'MAP Train']","['questionnaires of depressive symptoms, perceived stress, ruminative thoughts, and quality of life', 'time-efficient and evidence-based means of maintaining mental and physical wellness', 'Stress and Rumination While Enhancing Quality of Life', 'depressive', 'brooding ruminations', 'heart rate', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043217', 'cui_str': 'Wood'}, {'cui': 'C0036378', 'cui_str': 'Medical School'}]","[{'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442799', 'cui_str': 'Efficient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.0226093,"After 8 weeks of training and in contrast to students who did not participate, the medical students reported significantly fewer ruminations (-17%), including depressive (-16%) and brooding ruminations (-24%).","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lavadera', 'Affiliation': 'Robert Wood Johnson Medical School, Rutgers University Biomedical and Health Sciences, New Brunswick, NJ, USA.'}, {'ForeName': 'Emma M', 'Initials': 'EM', 'LastName': 'Millon', 'Affiliation': 'Behavioral and Systems Neuroscience, Department of Psychology, Center for Collaborative Neuroscience, Rutgers University, Piscataway, NJ, USA.'}, {'ForeName': 'Tracey J', 'Initials': 'TJ', 'LastName': 'Shors', 'Affiliation': 'Behavioral and Systems Neuroscience, Department of Psychology, Center for Collaborative Neuroscience, Rutgers University, Piscataway, NJ, USA.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0281']
329,31903657,"Methotrexate plus or minus cetuximab as first-line treatment in a recurrent or metastatic (R/M) squamous cell carcinoma population of the head and neck (SCCHN), unfit for cisplatin combination treatment, a phase Ib-randomized phase II study Commence.","BACKGROUND


Methotrexate in recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) has limited progression-free survival (PFS) benefit. We hypothesized that adding cetuximab to methotrexate improves PFS.
METHODS


In the phase-Ib-study, patients with R/M SCCHN received methotrexate and cetuximab as first-line treatment. The primary objective was feasibility. In the phase-II-study patients were randomized to this combination or methotrexate alone (2:1). The primary endpoint was PFS. Secondary endpoints were overall survival (OS), toxicity, and quality of life (QoL).
RESULTS


In six patients in the phase-Ib-study, no dose limiting toxicities were observed. In the phase II study, 30 patients received the combination and 15 patients methotrexate. In the phase-II-study median PFS was 4.5 months in the combination group vs 2.0 months in the methotrexate group (HR 0.37; P = .002). OS, toxicity, and QoL were not significantly different.
CONCLUSION


Cetuximab with methotrexate improved PFS without increased toxicity in R/M SCCHN-patients.",2020,"OS, toxicity, and QoL were not significantly different.
","['30 patients received the combination and 15 patients', 'recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN', 'a recurrent or metastatic (R/M) squamous cell carcinoma population of the head and neck (SCCHN']","['Methotrexate', 'Methotrexate plus or minus cetuximab', 'methotrexate and cetuximab', 'methotrexate']","['PFS', 'OS, toxicity, and QoL', 'limiting toxicities', 'overall survival (OS), toxicity, and quality of life (QoL', 'toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0034380'}]",30.0,0.0278112,"OS, toxicity, and QoL were not significantly different.
","[{'ForeName': 'Janneke C', 'Initials': 'JC', 'LastName': 'Ham', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, HB, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'van Meerten', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, GD, The Netherlands.'}, {'ForeName': 'W Edward', 'Initials': 'WE', 'LastName': 'Fiets', 'Affiliation': 'Department of Internal Medicine, Medical Center Leeuwarden, Leeuwarden, AD, The Netherlands.'}, {'ForeName': 'Laurens V', 'Initials': 'LV', 'LastName': 'Beerepoot', 'Affiliation': 'Department of Internal Medicine, Elisabeth TweeSteden Hospital, Tilburg, AD, The Netherlands.'}, {'ForeName': 'Frank J F', 'Initials': 'FJF', 'LastName': 'Jeurissen', 'Affiliation': 'Department of Internal Medicine, Medical Center Haaglanden, The Hague, VA, The Netherlands.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Slingerland', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, ZA, The Netherlands.'}, {'ForeName': 'Marianne A', 'Initials': 'MA', 'LastName': 'Jonker', 'Affiliation': 'Biostatistics, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, HB, The Netherlands.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Husson', 'Affiliation': 'Department of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Amsterdam, CX, The Netherlands.'}, {'ForeName': 'Winette T A', 'Initials': 'WTA', 'LastName': 'van der Graaf', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, HB, The Netherlands.'}, {'ForeName': 'Carla M L', 'Initials': 'CML', 'LastName': 'van Herpen', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, HB, The Netherlands.'}]",Head & neck,['10.1002/hed.26053']
330,32311466,Reduction in Post-Discharge Return to Acute Care in Hepatopancreatobiliary Surgery: Results of a Quality Improvement Initiative.,"BACKGROUND


Postoperative returns to acute care represent fragmented care, are costly, and often evolve into readmission. Reduction of postoperative readmissions and emergency department visits represents an opportunity to improve quality of care and decrease resource use. The aim of this study was to assess the impact of 2 failure modes and effects analysis-guided quality improvement interventions on return to acute care within 30 days postoperatively.
METHODS


An American College of Surgeons NSQIP database analysis of adult patients treated by a single hepatopancreatobiliary surgeon at a quaternary academic center was performed. Two failure modes and effects analysis-guided quality improvement interventions were assessed in a staged fashion, including a post-discharge phone call follow-up, and a preoperative clinic visit to discuss plans of care. The primary end point of interest was return to acute care (readmission or emergency department use) within 30 days from postoperative discharge.
RESULTS


During the 4-year study period, 684 patients underwent a hepatopancreatobiliary operation. After the implementation of the failure modes and effects analysis interventions, the baseline 30-day readmission rate was reduced by 48% post intervention (13.5% vs 6.9%; p = 0.011). This impact was sustained, with a readmission rate below the lowest baseline in 5 of 6 postintervention quarters. Short-stay readmissions were reduced by > 76% after the interventions (28.5% vs 6.6%). Post-discharge emergency department visits were also reduced by nearly 40% after initiation of both failure modes and effects analysis-guided quality improvement interventions (11.3% vs 6.9%; p = 0.125), which showed similar sustained response.
CONCLUSIONS


The results from this study can be used to help identify, develop, and test interventions to optimize emergency department use and readmission to reduce healthcare costs and improve patient quality of life.",2020,"This impact was sustained, with a readmission rate below the lowest baseline in 5 of 6 post-intervention quarters.","['684 patients underwent an HPB operation', 'Hepatopancreatobiliary Surgery', 'return to acute care within 30 days postoperatively', 'adult patients treated by a single hepatopancreatobiliary surgeon at a quaternary academic center was performed']",['FMEA-guided quality improvement (FQI) interventions'],"['return to acute care (readmission or ED utilization', 'patient quality of life', 'readmission rate', 'Post-discharge emergency department visits', 'Short-stay readmissions', 'baseline 30-day readmission rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}]",684.0,0.0355843,"This impact was sustained, with a readmission rate below the lowest baseline in 5 of 6 post-intervention quarters.","[{'ForeName': 'Brendan P', 'Initials': 'BP', 'LastName': 'Lovasik', 'Affiliation': 'Department of Surgery, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Blair', 'Affiliation': 'Department of Surgery, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Little', 'Affiliation': 'Department of Surgery, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Marty', 'Initials': 'M', 'LastName': 'Sellers', 'Affiliation': 'Department of Surgery, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Sweeney', 'Affiliation': 'Department of Surgery, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Juan M', 'Initials': 'JM', 'LastName': 'Sarmiento', 'Affiliation': 'Department of Surgery, Emory University School of Medicine, Atlanta, GA. Electronic address: jmsarmie@emory.edu.'}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2020.03.034']
331,32312759,Serum Metabolomic Response to Low- and High-Dose Vitamin E Supplementation in Two Randomized Controlled Trials.,"BACKGROUND


Vitamin E is an essential micronutrient and critical human antioxidant previously tested for cancer preventative effects with conflicting clinical trial results that have yet to be explained biologically.
METHODS


We examined baseline and on-trial serum samples for 154 men randomly assigned to receive 400 IU vitamin E (as alpha-tocopheryl acetate; ATA) or placebo daily in the Vitamin E Atherosclerosis Prevention Study (VEAPS), and for 100 men administered 50 IU ATA or placebo daily in the Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study (ATBC). Over 970 metabolites were identified using ultrahigh-performance LC/MS-MS. Linear regression models estimated the change in serum metabolites of men supplemented with vitamin E versus those receiving placebo in VEAPS as compared with ATBC.
RESULTS


Serum alpha-carboxyethyl hydrochroman (CEHC) sulfate, alpha-tocopherol, and beta/gamma-tocopherol were significantly altered by ATA supplementation in both trials (all  P  values ≤5.1 × 10 -5 , the Bonferroni multiple comparisons corrected statistical threshold). Serum C 22  lactone sulfate was significantly decreased in response to the high-dose vitamin E in VEAPS (β = -0.70,  P  = 8.1 × 10 -6 ), but not altered by the low dose in ATBC (β = -0.17,  P  = 0.4). In addition, changes in androgenic steroid metabolites were strongly correlated with the vitamin E supplement-associated change in C 22  lactone sulfate only in the VEAPS trial.
CONCLUSIONS


We found evidence of a dose-dependent vitamin E supplementation effect on a novel C 22  lactone sulfate compound that was correlated with several androgenic steroids.
IMPACT


Our data add information on a differential hormonal response based on vitamin E dose that could have direct relevance to opposing prostate cancer incidence results from previous large controlled trials.",2020,"Serum C22 lactone sulfate was significantly decreased in response to the high-dose vitamin E in VEAPS (β=-0.70, p-value=8.1×10-6) but not altered by the low-dose in ATBC (","['100 men administered', '154 men randomly assigned to receive']","['placebo', '50 IU ATA or placebo', '400 IU vitamin E (as alpha-tocopheryl acetate; ATA) or placebo', 'Low- and High-Dose Vitamin E Supplementation', 'vitamin E']","['Serum Metabolomic Response', 'Serum C22 lactone sulfate', 'Serum alpha-carboxyethyl hydrochroman (CEHC) sulfate, alpha-tocopherol, and beta-/gamma-tocopherol', 'androgenic steroid metabolites', 'C22 lactone sulfate']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002602', 'cui_str': 'Aminotriazole'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C1999896', 'cui_str': 'Alpha tocopherol acetate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C4524012', 'cui_str': 'Vitamin E supplementation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0754985', 'cui_str': ""N,N'-ethylenebis(benzohydroxamamide)""}, {'cui': 'C0022947', 'cui_str': 'Lactone'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0969677', 'cui_str': 'alpha Tocopherol'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",970.0,0.292577,"Serum C22 lactone sulfate was significantly decreased in response to the high-dose vitamin E in VEAPS (β=-0.70, p-value=8.1×10-6) but not altered by the low-dose in ATBC (","[{'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, Maryland. jiaqi.huang@nih.gov daa@nih.gov.'}, {'ForeName': 'Howard N', 'Initials': 'HN', 'LastName': 'Hodis', 'Affiliation': 'Atherosclerosis Research Unit, Department of Preventive Medicine, Keck School of Medicine, University of Southern California (USC), Los Angeles, California.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Weinstein', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, Maryland.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': 'Atherosclerosis Research Unit, Department of Preventive Medicine, Keck School of Medicine, University of Southern California (USC), Los Angeles, California.'}, {'ForeName': 'Joshua N', 'Initials': 'JN', 'LastName': 'Sampson', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, Maryland.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Mondul', 'Affiliation': 'Department of Epidemiology, University of Michigan School of Public Health, Ann Arbor, Michigan.'}, {'ForeName': 'Demetrius', 'Initials': 'D', 'LastName': 'Albanes', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, Maryland. jiaqi.huang@nih.gov daa@nih.gov.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-20-0187']
332,32311455,"Disposition of two highly permeable drugs in the upper gastrointestinal lumen of healthy adults after a standard high-calorie, high-fat meal.","OBJECTIVES


To quantify the presence of two model highly permeable drugs, paracetamol and danazol, in the upper gastrointestinal lumen under conditions simulating the situation after disintegration of immediate release dosage forms administered in bioavailability/bioequivalence studies in the fed state. To understand the drug transfer process from the antral contents through the upper small intestine based on luminal drug data.
METHODS


8 healthy male adult volunteers participated in a randomized, single dose, two-phase, crossover study. After evaluating the impact of homogenization on meal's viscosity and particle size, the meal, containing phenol red as non-absorbable marker, was administered to the antrum via the gastric lumen of a naso-gastro-intestinal tube. The drugs were administered in solution form (Phase I) and in suspension form (Phase II) with a glass of tap water to the antrum of the stomach, 30 min after the initiation of meal administration. Samples were aspirated from the antrum and the upper small intestine up to 4 hours post drug administration.
RESULTS


Apparent concentrations in the aqueous contents of the antrum were higher than apparent concentrations in the micellar contents of the upper small intestine for paracetamol; the opposite was observed for danazol. Based on total drug amount per volume data in contents of the upper gastrointestinal lumen, the transfer of paracetamol (aqueous solution or suspension) and danazol (aqueous suspension) through the upper small intestine could be described as an apparent first-order process. Transfer of a long-chain triglyceride solution of danazol was highly variable.
CONCLUSIONS


Concentrations in the aqueous/micellar phase of luminal contents and values of parameters controlling the transfer from bulk gastric contents through the upper small intestine after a high-calorie, high-fat meal, were reported for the first time for highly permeable drugs. Data are expected to enhance the development of biorelevant in vitro and physiologically based biopharmaceutics modelling methodologies.",2020,"After evaluating the impact of homogenization on meal's viscosity and particle size, the meal, containing phenol red as non-absorbable marker, was administered to the antrum via the gastric lumen of a naso-gastro-intestinal tube.",['8 healthy male adult volunteers'],"['paracetamol and danazol', 'danazol', 'paracetamol (aqueous solution or suspension) and danazol (aqueous suspension']",[],"[{'cui': 'C0686751', 'cui_str': 'Well male adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0010961', 'cui_str': 'Danazol'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]",[],8.0,0.0387024,"After evaluating the impact of homogenization on meal's viscosity and particle size, the meal, containing phenol red as non-absorbable marker, was administered to the antrum via the gastric lumen of a naso-gastro-intestinal tube.","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Pentafragka', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Zografou, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vertzoni', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Zografou, Greece.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Symillides', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Zografou, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Goumas', 'Affiliation': 'Department of Gastroenterology, Red Cross Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Reppas', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Zografou, Greece. Electronic address: reppas@pharm.uoa.gr.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105351']
333,32040523,The long-term effects of a family based economic empowerment intervention (Suubi+Adherence) on suppression of HIV viral loads among adolescents living with HIV in southern Uganda: Findings from 5-year cluster randomized trial.,"BACKGROUND


The rapid scale-up of HIV therapy across Africa has failed to adequately engage adolescents living with HIV (ALWHIV). Retention and viral suppression for this group (ALWHIV) is 50% lower than for adults. Indeed, on the African continent, HIV remains the single leading cause of mortality among adolescents. Strategies tailored to the unqiue developmental and social vulnerabilities of this group are urgently needed to enhance successful treatment.
METHODS


We carried out a five-year longitudinal cluster randomized trial (ClinicalTrials.gov ID: NCT01790373) with adolescents living with HIV (ALWHIV) ages 10 to 16 years clustered at health care clinics to test the effect of a family economic empowerment (EE) intervention on viral suppression in five districuts in Uganda. In total, 39 accredited health care clinics from study districts with existing procedures tailored to adolescent adherence were eligible to participate in the trial. We used data from 288 youth with detectable HIV viral loads (VL) at baseline (158 -intervention group from 20 clinics, 130 -non-intervention group from 19 clinics). The primary end point was undetectable plasma HIV RNA levels, defined as < 40 copies/ml. We used Kaplan-Meier (KM) analysis and Cox proportional hazard models to estimate intervention effects.
FINDINGS


The Kaplan-Meier (KM) analysis indicated that an incidence of undetectable VL (0.254) was significantly higher in the intervention condition compared to 0.173 (in non-intervention arm) translated into incidence rate ratio of 1.468 (CI: 1.064-2.038), p = 0.008. Cox regression results showed that along with the family-based EE intervention (adj. HR = 1.446, CI: 1.073-1.949, p = 0.015), higher number of medications per day had significant positive effects on the viral suppression (adj.HR = 1.852, CI: 1.275-2.690, p = 0.001).
INTERPRETATION


A family economic empowerment intervention improved treatment success for ALWHIV in Uganda. Analyses of cost effectiveness and scalability are needed to advance incorporation of this intervention into routine practice in low and middle-income countries.",2020,"HR = 1.852, CI: 1.275-2.690, p = 0.001).
","['adolescents living with HIV (ALWHIV) ages 10 to 16 years clustered at health care clinics', '288 youth with detectable HIV viral loads (VL) at baseline (158 -intervention group from 20 clinics, 130 -non-intervention group from 19 clinics', 'In total, 39 accredited health care clinics from study districts with existing procedures tailored to adolescent adherence were eligible to participate in the trial', 'adolescents living with HIV in southern Uganda']","['family based economic empowerment intervention (Suubi+Adherence', 'family economic empowerment (EE) intervention']","['Retention and viral suppression', 'viral suppression', 'suppression of HIV viral loads', 'undetectable plasma HIV RNA levels']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",288.0,0.0770241,"HR = 1.852, CI: 1.275-2.690, p = 0.001).
","[{'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Washington University School of Medicine, Washington University in St. Louis, St. Louis, MO, United States of America.'}, {'ForeName': 'Darejan', 'Initials': 'D', 'LastName': 'Dvalishvili', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, MO, United States of America.'}, {'ForeName': 'Claude A', 'Initials': 'CA', 'LastName': 'Mellins', 'Affiliation': 'Department of Psychiatry, New York State Psychiatric Institute, HIV Center for Clinical and Behavioral Studies at Columbia University Medical Center, The City of New York, NY, United States of America.'}, {'ForeName': 'Elvin H', 'Initials': 'EH', 'LastName': 'Geng', 'Affiliation': 'Division of Infectious Diseases, John T. Milliken Department of Internal Medicine, Washington University in St. Louis, St. Louis, MO, United States of America.'}, {'ForeName': 'Fredderick', 'Initials': 'F', 'LastName': 'Makumbi', 'Affiliation': 'School of Public Health, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'Division of Prevention Science, Center for AIDS Prevention Studies (CAPS), Department of Medicine, University of California, San Francisco, San Francisco, CA, United States of America.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'McKay', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, MO, United States of America.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Damulira', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Uganda Office, Masaka, Uganda.'}, {'ForeName': 'Proscovia', 'Initials': 'P', 'LastName': 'Nabunya', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, MO, United States of America.'}, {'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Sensoy Bahar', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, MO, United States of America.'}, {'ForeName': 'Gertrude', 'Initials': 'G', 'LastName': 'Nakigozi', 'Affiliation': 'Rakai Health Sciences Program, Kalisizo, Uganda.'}, {'ForeName': 'Godfrey', 'Initials': 'G', 'LastName': 'Kigozi', 'Affiliation': 'Rakai Health Sciences Program, Kalisizo, Uganda.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Byansi', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, MO, United States of America.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Mukasa', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Uganda Office, Masaka, Uganda.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Namuwonge', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Uganda Office, Masaka, Uganda.'}]",PloS one,['10.1371/journal.pone.0228370']
334,32301699,Comparative efficacy and safety of 100 mg and 200 mg filgotinib administered to patients with active rheumatoid arthritis: A Bayesian network meta-analysis of randomized controlled trials
.,"OBJECTIVES


We assessed the relative efficacy and safety of once-daily administration of 100 and 200 mg filgotinib (a JAK1-selective inhibitor) in patients with active rheumatoid arthritis (RA).
MATERIALS AND METHODS


We conducted a Bayesian network meta-analysis combining the direct and indirect evidence from randomized controlled trials (RCTs) that examined the efficacy and safety of filgotinib in patients with active RA.
RESULTS


Five RCTs involving 3,920 patients met the inclusion criteria. There were 15 pairwise comparisons, including 8 direct comparisons and 7 interventions. The ACR20 response rate was significantly higher in the filgotinib 200 mg + methotrexate (MTX) group than in the placebo or placebo + MTX group (odds ratio (OR): 12.39, 95% credible interval (CrI): 3.36 - 45.98.10; OR: 2.68, 95% CrI: 1.80 - 4.39). Compared to the placebo group, the filgotinib 100 mg, adalimumab 40 mg + MTX, filgotinib 200 mg, and placebo + MTX groups showed a significantly higher ACR20 response rate. The ranking probability based on the surface under the cumulative ranking curve (SUCRA) indicated filgotinib 200 mg + MTX was likely to achieve the best ACR20 response rate (SUCRA = 0.902), followed by filgotinib 100 mg + MTX (SUCRA = 0.694), filgotinib 100 mg (SUCRA = 0.675), adalimumab 40 mg + MTX (SUCRA = 0.661), filgotinib 200 mg (SUCRA = 0.305), placebo + MTX (SUCRA = 0.259), and placebo (SUCRA = 0.005). The safety based on the number of serious adverse events (SAEs) did not differ significantly among 6 six interventions.
CONCLUSION


Filgotinib 100 and 200 mg administration once daily in combination with MTX was the most efficacious intervention for active RA, with no significant risk of SAEs.",2020,"The safety based on the number of serious adverse events (SAEs) did not differ significantly among 6 six interventions.
","['patients with active rheumatoid arthritis', 'patients with active RA', '3,920 patients met the inclusion criteria', 'patients with active rheumatoid arthritis (RA']","['placebo + MTX', 'filgotinib 200 mg + methotrexate (MTX', 'adalimumab 40 mg + MTX, filgotinib 200 mg, and placebo + MTX', 'filgotinib (a JAK1-selective inhibitor', 'placebo', '100\xa0mg and 200 mg filgotinib', 'placebo or placebo + MTX', 'adalimumab 40\xa0mg + MTX', 'MTX']","['ACR20 response rate', 'efficacy and safety of filgotinib', 'relative efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0169658', 'cui_str': 'JAK1 Protein Tyrosine Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",3920.0,0.469101,"The safety based on the number of serious adverse events (SAEs) did not differ significantly among 6 six interventions.
","[{'ForeName': 'Gwan Gyu', 'Initials': 'GG', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Young Ho', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203635']
335,32301701,"Effects of antibiotics on prevention of infection, white blood cell counts, and C-reactive protein levels at different times in the perioperative period of cesarean section
.","OBJECTIVE


To evaluate the effects of antibiotics on prevention of infection, white blood cell (WBC) counts and C-reactive protein (CRP) levels at different times in the perioperative period of cesarean section.
MATERIALS AND METHODS


A total of 486 women undergoing cesarean section were randomly divided into groups A, B, and C (n = 162). Group A was intravenously infused with 250 mL of 0.9% normal saline containing 2 g cefuroxime sodium 30 minutes before surgery within 30 - 45 minutes. Group B was given cefuroxime 30 minutes before surgery and 3 days after surgery, respectively. Group C was given cefuroxime only after returning to ward, once daily for 3 consecutive days. The surgical time, intraoperative blood loss, postoperative hospital-stay length, hospitalization expenditure, maximum body temperature, WBC count and CRP level 3 days after surgery, grade A healing rate of incision at discharge, and incidence of infection were compared.
RESULTS


Group A had the shortest postoperative hospital-stay length and lowest hospitalization expenditure (p < 0.05). The maximum body temperature, WBC count and CRP level of group A 3 days after surgery were lowest (p < 0.05). The three groups had similar grade A healing rates of incision (p > 0.05). The postoperative infection rates of groups A and B were similar (p > 0.05), both being significantly lower than that of group C (p < 0.05).
CONCLUSION


Single prophylactic use of antibiotics 30 minutes before surgery effectively prevented infection after cesarean section and shortened the hospital-stay length. This method is worthy of clinical promotion due to short duration of antibiotic use and low hospitalization expenditure.",2020,"The postoperative infection rates of groups A and B were similar (p > 0.05),",['486 women undergoing cesarean section'],"['250\xa0mL of 0.9% normal saline containing 2\xa0g cefuroxime sodium', 'cefuroxime', 'antibiotics']","['prevention of infection, white blood cell counts, and C-reactive protein levels', 'CRP) levels', 'surgical time, intraoperative blood loss, postoperative hospital-stay length, hospitalization expenditure, maximum body temperature, WBC count and CRP level 3\xa0days after surgery, grade A healing rate of incision at discharge, and incidence of infection', 'shortest postoperative hospital-stay length and lowest hospitalization expenditure', 'prevention of infection, white blood cell (WBC) counts and C-reactive protein ', 'grade A healing rates of incision', 'maximum body temperature, WBC count and CRP level', 'hospital-stay length', 'postoperative infection rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439166', 'cui_str': '% normal'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0701852', 'cui_str': 'Cefuroxime sodium'}, {'cui': 'C0007562', 'cui_str': 'Cefuroxime'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0309195', 'cui_str': 'Grade A'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0392618', 'cui_str': 'Postoperative infection'}]",486.0,0.021812,"The postoperative infection rates of groups A and B were similar (p > 0.05),","[{'ForeName': 'Xiuyan', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Linxiao', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Aichun', 'Initials': 'A', 'LastName': 'Sun', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203647']
336,32101767,Randomized Controlled Simulation Trial to Compare Transfer Procedures for Emergency Cesarean.,"OBJECTIVE


To test the hypothesis that capping intravenous and epidural lines would reduce time to transfer women in labor to the operating room and time to readiness for general anesthesia for emergency cesarean. The secondary purpose was to identify latent threats to patient safety.
DESIGN


Mixed methods analysis of a randomized, controlled, in situ simulation trial.
SETTING


Labor and delivery unit at high-risk referral center.
PARTICIPANTS


Fifteen interprofessional teams that included labor and delivery nurses and anesthesiology residents.
METHODS


Immediately before simulation, we randomized bedside nurses and anesthesiology residents to one of two groups: usual transfer or the cap and run procedure. Simulation scenarios started with fetal heart rate decelerations that necessitated position changes followed by emergency cesarean. An embedded simulated obstetrician announced the decision for cesarean; completion of an OR checklist confirmed team readiness to induce general anesthesia. Postsimulation debriefing was focused on teamwork and opportunities to improve safety, and we used qualitative analysis to synthesize results.
RESULTS


We found no statistically significant difference in the overall time from decision for cesarean to readiness for general anesthesia between the two groups (usual transfer median = 445 seconds [interquartile range, 425-465] vs. cap and run 390 seconds [interquartile range, 383-443], p = .12). The time in the operating room was less in the cap and run group than in the usual transfer group (median = 300 seconds vs. 250 seconds, p = .038). Qualitative analysis of the debriefing data indicated advantages of the capping procedure, including better bed maneuverability and fewer tangled lines.
CONCLUSION


We found no evidence of decreased overall time from decision for cesarean to readiness for general anesthesia based on whether the nurse capped the intravenous and epidural lines or pushed the intravenous pole alongside the bed. However, nurses perceived improved patient safety with the cap and run procedure.",2020,"We found no statistically significant difference in the overall time from decision for cesarean to readiness for general anesthesia between the two groups (usual transfer median = 445 s [interquartile range, 425-465] vs. cap and run 390 s","['Fifteen interprofessional teams that included labor and delivery nurses and anesthesiology residents', 'Emergency Cesarean', 'Labor and delivery unit at high-risk referral center']",['usual transfer or the cap and run procedure'],"['time in the operating room', 'patient safety']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C1321138', 'cui_str': 'Labor and delivery unit'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C1113679'}]",,0.113326,"We found no statistically significant difference in the overall time from decision for cesarean to readiness for general anesthesia between the two groups (usual transfer median = 445 s [interquartile range, 425-465] vs. cap and run 390 s","[{'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Mhyre', 'Affiliation': ''}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ward', 'Affiliation': ''}, {'ForeName': 'Teresa M', 'Initials': 'TM', 'LastName': 'Whited', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Anders', 'Affiliation': ''}]","Journal of obstetric, gynecologic, and neonatal nursing : JOGNN",['10.1016/j.jogn.2020.01.006']
337,32073177,Posttraumatic Growth After MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder.,"3,4-Methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for posttraumatic stress disorder (PTSD) has been shown to significantly reduce clinical symptomatology, but posttraumatic growth (PTG), which consists of positive changes in self-perception, interpersonal relationships, or philosophy of life, has not been studied with this treatment. Participant data (n = 60) were pooled from three Phase 2 clinical studies employing triple-blind crossover designs. Participants were required to meet DSM-IV-R criteria for PTSD with a score higher than 50 on the Clinician-Administered PTSD Scale (CAPS-IV) as well as previous inadequate response to pharmacological and/or psychotherapeutic treatment. Data were aggregated into two groups: an active MDMA dose group (75-125 mg of MDMA; n = 45) or placebo/active control (0-40 mg of MDMA; n = 15). Measures included the Posttraumatic Growth Inventory (PTGI) and the CAPS-IV, which were administered at baseline, primary endpoint, treatment exit, and 12-month follow-up. At primary endpoint, the MDMA group demonstrated more PTG, Hedges' g = 1.14, 95% CI [0.49, 1.78], p < .001; and a larger reduction in PTSD symptom severity, Hedges' g = 0.88, 95% CI [-0.28, 1.50], p < .001, relative to the control group. Relative to baseline, at the 12-month follow-up, within-subject PTG was higher, p < .001; PTSD symptom severity scores were lower, p < .001; and two-thirds of participants (67.2%) no longer met criteria for PTSD. MDMA-assisted psychotherapy for PTSD resulted in PTG and clinical symptom reductions of large-magnitude effect sizes. Results suggest that PTG may provide a new mechanism of action warranting further study.",2020,"At primary endpoint, the MDMA group demonstrated more PTG, Hedges' g = 1.14, 95% CI [0.49, 1.78], p < .001; and a larger reduction in PTSD symptom severity, Hedges' g = 0.88, 95% CI [-0.28, 1.50], p < .001, relative to the control group.",['posttraumatic stress disorder (PTSD'],"['3,4-Methylenedioxymethamphetamine (MDMA)-assisted psychotherapy', 'MDMA-Assisted Psychotherapy', 'MDMA', 'PTG', 'MDMA-assisted psychotherapy', 'placebo/active control (0-40 mg of MDMA']","['Posttraumatic Growth', 'PTSD symptom severity scores', 'Posttraumatic Growth Inventory (PTGI) and the CAPS-IV', 'PTSD symptom severity']","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C4704809', 'cui_str': 'Posttraumatic Growth'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}]",60.0,0.0371367,"At primary endpoint, the MDMA group demonstrated more PTG, Hedges' g = 1.14, 95% CI [0.49, 1.78], p < .001; and a larger reduction in PTSD symptom severity, Hedges' g = 0.88, 95% CI [-0.28, 1.50], p < .001, relative to the control group.","[{'ForeName': 'Ingmar', 'Initials': 'I', 'LastName': 'Gorman', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York, New York, USA.'}, {'ForeName': 'Alexander B', 'Initials': 'AB', 'LastName': 'Belser', 'Affiliation': 'School of Medicine, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Jerome', 'Affiliation': 'MAPS Public Benefit Corporation, Santa Cruz, California, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Hennigan', 'Affiliation': 'MAPS Public Benefit Corporation, Santa Cruz, California, USA.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Shechet', 'Affiliation': 'Scottsdale Research Institute, Phoenix, Arizona, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hamilton', 'Affiliation': 'Stanford University School of Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Berra', 'Initials': 'B', 'LastName': 'Yazar-Klosinski', 'Affiliation': 'Multidisciplinary Association for Psychedelic Studies, Santa Cruz, California, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Emerson', 'Affiliation': 'MAPS Public Benefit Corporation, Santa Cruz, California, USA.'}, {'ForeName': 'Allison A', 'Initials': 'AA', 'LastName': 'Feduccia', 'Affiliation': 'MAPS Public Benefit Corporation, Santa Cruz, California, USA.'}]",Journal of traumatic stress,['10.1002/jts.22479']
338,32077550,The Impact of Anlotinib on Brain Metastases of Non-Small Cell Lung Cancer: Post Hoc Analysis of a Phase III Randomized Control Trial (ALTER0303).,"BACKGROUND


Anlotinib has been shown to prolong progression-free survival (PFS) and overall survival (OS) for non-small cell lung cancer (NSCLC). Herein we sought to analyze the effect of anlotinib in managing brain metastases (BM) and its brain-associated toxicities.
METHODS


The PFS and OS of anlotinib versus placebo in those with and without BM recorded at baseline were calculated and compared respectively. Time to brain progression (TTBP), a direct indicator of intracranial control, was also compared between anlotinib and placebo. All calculations were adjusted for confounding factors, including stage, histology, driver mutation type, and therapy history.
RESULTS


A total of 437 patients were included; 97 cases were recorded with BM at baseline. For patients with BM at baseline, anlotinib was associated with longer PFS (hazard ratio [HR], 0.29; 95% confidence interval [CI], 0.15-0.56) and OS (HR, 0.72; 95% CI, 0.42-1.12), presenting similar extent of improvement in those without BM (PFS: HR, 0.33; 95% CI, 0.24-0.45; OS: HR, 0.67; 95% CI, 0.50-0.91). Specifically, the intracranial objective response rate was 14.3% and the disease control rate was 85.7% in patients with BM who were treated with anlotinib. Anlotinib was associated with longer TTBP (HR, 0.11; 95% CI, 0.03-0.41; p = .001) despite all confounders. Additionally, anlotinib was associated with more neural toxicities (18.4% vs. 8.4%) and psychological symptoms (49.3% vs. 35.7%) but not with infarction or cerebral hemorrhage.
CONCLUSION


Anlotinib can benefit patients with advanced NSCLC with BM and is highly potent in the management of intracranial lesions. Its special effect on BM and cerebral tissue merits further investigation. (ClinicalTrials.gov ID: NCT02388919).",2020,"Anlotinib was associated with longer TTBP (HR, 0.11; 95% CI, 0.03-0.41; p = .001) despite all confounders.",['A total of 437 patients were included; 97 cases were recorded with BM at baseline'],['placebo'],"['neural toxicities', 'progression-free survival (PFS) and overall survival (OS', 'intracranial objective response rate', 'psychological symptoms', 'disease control rate', 'Time to brain progression (TTBP']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",437.0,0.467281,"Anlotinib was associated with longer TTBP (HR, 0.11; 95% CI, 0.03-0.41; p = .001) despite all confounders.","[{'ForeName': 'Shunjun', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}, {'ForeName': 'Hengrui', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}, {'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}, {'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': ""Department of General Internal Medicine, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}, {'ForeName': 'Zhanhong', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yalei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}, {'ForeName': 'Baohui', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': ""Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, People's Republic of China.""}, {'ForeName': 'Jianxing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}]",The oncologist,['10.1634/theoncologist.2019-0838']
339,30680768,Treatment of exudative age-related macular degeneration with aflibercept combined with pranoprofen eye drops or nutraceutical support with omega-3: A randomized trial.,"AIMS


The aim of this study was to determine whether a combination of intravitreal aflibercept (IVA) and pranoprofen eyedrops or nutraceutical support provides additional benefit over IVA monotherapy for the treatment of choroidal neovascularization (CNV) in age-related macular degeneration.
METHODS


This was a prospective, randomized, pilot study in 60 patients with treatment-naïve CNV. Patients were randomized 1:1:1 into three groups: aflibercept monotherapy (AM), aflibercept plus pranoprofen (AP) or aflibercept plus nutraceutical (AN) tablets containing multivitamin antioxidant and mineral supplementation plus omega-3.
RESULTS


At 12 months, all groups showed significant improvement in both best-corrected visual acuity (BCVA) and central retinal thickness (CRT). The mean BCVA change from baseline to 12 months was -0.26 ± 0.06 LogMAR, -0.30 ± 0.06 LogMAR and -0.24 ± 0.04 LogMAR in the AM, AP and AN groups, respectively. The mean CRT change from baseline to 12 months was -76.9 ± 10.9 μm, -129 ± 19.9 μm and -105 ± 11.6 μm in the AM, AP and AN groups, respectively. The AN group required one less IVA injection than the AM group.
CONCLUSIONS


Compared with AM, both combination groups acted synergistically, although no significant benefits in BCVA were found over AM. Nutraceutical support with omega-3 leads to a reduced need for IVA.",2019,"At 12 months, all groups showed significant improvement in both best-corrected visual acuity (BCVA) and central retinal thickness (CRT).","['60 patients with treatment-naïve CNV', 'choroidal neovascularization (CNV) in age-related macular degeneration']","['aflibercept combined with pranoprofen eye drops or nutraceutical support with omega-3', 'aflibercept monotherapy (AM), aflibercept plus pranoprofen (AP) or aflibercept plus nutraceutical (AN) tablets containing multivitamin antioxidant and mineral supplementation plus omega-3', 'intravitreal aflibercept (IVA) and pranoprofen eyedrops']","['mean CRT change', 'best-corrected visual acuity (BCVA) and central retinal thickness (CRT', 'BCVA', 'mean BCVA change']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600518', 'cui_str': 'Neovascularization, Choroid'}, {'cui': 'C0242383', 'cui_str': 'Maculopathy, Age-Related'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0072652', 'cui_str': 'alpha-methyl-5H-(1)benzopyrano(2,3-b)pyridine-7-acetic acid'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C1518478', 'cui_str': 'Nutraceuticals'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C1384599', 'cui_str': 'Mineral supplement therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}]",60.0,0.0621731,"At 12 months, all groups showed significant improvement in both best-corrected visual acuity (BCVA) and central retinal thickness (CRT).","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Semeraro', 'Affiliation': 'Eye Clinic, Department of Neurological and Vision Sciences, University of Brescia, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Gambicordi', 'Affiliation': 'Eye Clinic, Department of Neurological and Vision Sciences, University of Brescia, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cancarini', 'Affiliation': 'Eye Clinic, Department of Neurological and Vision Sciences, University of Brescia, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Morescalchi', 'Affiliation': 'Eye Clinic, Department of Neurological and Vision Sciences, University of Brescia, Italy.'}, {'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Costagliola', 'Affiliation': 'Eye Clinic, Department of Health Sciences, University of Molise, Campobasso, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Russo', 'Affiliation': 'Eye Clinic, Department of Neurological and Vision Sciences, University of Brescia, Italy.'}]",British journal of clinical pharmacology,['10.1111/bcp.13871']
340,31796986,"GLP-1 secretion is regulated by IL-6 signalling: a randomised, placebo-controlled study.","AIMS/HYPOTHESIS


IL-6 is a cytokine with various effects on metabolism. In mice, IL-6 improved beta cell function and glucose homeostasis via upregulation of glucagon-like peptide 1 (GLP-1), and IL-6 release from muscle during exercise potentiated this beneficial increase in GLP-1. This study aimed to identify whether exercise-induced IL-6 has a similar effect in humans.
METHODS


In a multicentre, double-blind clinical trial, we randomly assigned patients with type 2 diabetes or obesity to intravenous tocilizumab (an IL-6 receptor antagonist) 8 mg/kg every 4 weeks, oral sitagliptin (a dipeptidyl peptidase-4 inhibitor) 100 mg daily or double placebos (a placebo saline infusion every 4 weeks and a placebo pill once daily) during a 12 week training intervention. The primary endpoints were the difference in change of active GLP-1 response to an acute exercise bout and change in the AUC for the concentration-time curve of active GLP-1 during mixed meal tolerance tests at baseline and after the training intervention.
RESULTS


Nineteen patients were allocated to tocilizumab, 17 to sitagliptin and 16 to placebos. During the acute exercise bout active GLP-1 levels were 26% lower with tocilizumab (multiplicative effect: 0.74 [95% CI 0.56, 0.98], p = 0.034) and 53% higher with sitagliptin (1.53 [1.15, 2.03], p = 0.004) compared with placebo. After the 12 week training intervention, the active GLP-1 AUC with sitagliptin was about twofold that with placebo (2.03 [1.56, 2.62]; p < 0.001), while GLP-1 AUC values showed a small non-significant decrease of 13% at 4 weeks after the last tocilizumab infusion (0.87 [0.67, 1.12]; p = 0.261).
CONCLUSIONS/INTERPRETATION


IL-6 is implicated in the regulation of GLP-1 in humans. IL-6 receptor blockade lowered active GLP-1 levels in response to a meal and an acute exercise bout in a reversible manner, without lasting effects beyond IL-6 receptor blockade.
TRIAL REGISTRATION


Clinicaltrials.gov NCT01073826.
FUNDING


Danish National Research Foundation. Danish Council for Independent Research. Novo Nordisk Foundation. Danish Centre for Strategic Research in Type 2 Diabetes. European Foundation for the Study of Diabetes. Swiss National Research Foundation.",2020,IL-6,"['Nineteen patients', 'patients with type 2 diabetes or obesity to intravenous']","['exercise-induced IL-6', 'IL-6', 'double placebos (a placebo saline', 'tocilizumab (an IL-6 receptor antagonist) 8\xa0mg/kg every 4\xa0weeks, oral sitagliptin (a dipeptidyl peptidase-4 inhibitor', 'placebo', 'tocilizumab', 'placebos']","['active GLP-1 AUC with sitagliptin', 'GLP-1 AUC values', 'beta cell function and glucose homeostasis via upregulation of glucagon-like peptide 1 (GLP-1), and IL-6 release', 'GLP-1 secretion', 'acute exercise bout active GLP-1 levels', 'change of active GLP-1 response to an acute exercise bout and change in the AUC for the concentration-time curve of active GLP-1 during mixed meal tolerance tests']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0063717', 'cui_str': 'Receptors, IL-6'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1275555', 'cui_str': 'q4wk'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0041904', 'cui_str': 'Up-Regulation (Physiology)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test (procedure)'}]",,0.710886,IL-6,"[{'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Ellingsgaard', 'Affiliation': 'Centre of Inflammation and Metabolism (CIM)/ Centre for Physical Activity Research (CFAS), Rigshospitalet 7641, Blegdamsvej 9, DK-2100, Copenhagen, Denmark. Helga.Ellingsgaard@regionh.dk.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Seelig', 'Affiliation': 'Clinic of Endocrinology, Diabetes and Metabolism University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Timper', 'Affiliation': 'Clinic of Endocrinology, Diabetes and Metabolism University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Coslovsky', 'Affiliation': 'Department of Clinical Research, CTU, University of Basel, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Soederlund', 'Affiliation': 'Centre of Inflammation and Metabolism (CIM)/ Centre for Physical Activity Research (CFAS), Rigshospitalet 7641, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Lyngbaek', 'Affiliation': 'Centre of Inflammation and Metabolism (CIM)/ Centre for Physical Activity Research (CFAS), Rigshospitalet 7641, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Nicolai J', 'Initials': 'NJ', 'LastName': 'Wewer Albrechtsen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'Schmidt-Trucksäss', 'Affiliation': 'Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Henner', 'Initials': 'H', 'LastName': 'Hanssen', 'Affiliation': 'Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Walter O', 'Initials': 'WO', 'LastName': 'Frey', 'Affiliation': 'Balgrist MoveMed, Swiss Olympic Medical Center, University Hospital Balgrist, Zurich, Switzerland.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Karstoft', 'Affiliation': 'Centre of Inflammation and Metabolism (CIM)/ Centre for Physical Activity Research (CFAS), Rigshospitalet 7641, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Bente K', 'Initials': 'BK', 'LastName': 'Pedersen', 'Affiliation': 'Centre of Inflammation and Metabolism (CIM)/ Centre for Physical Activity Research (CFAS), Rigshospitalet 7641, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Böni-Schnetzler', 'Affiliation': 'Department Biomedicine, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Marc Y', 'Initials': 'MY', 'LastName': 'Donath', 'Affiliation': 'Clinic of Endocrinology, Diabetes and Metabolism University Hospital Basel, Basel, Switzerland.'}]",Diabetologia,['10.1007/s00125-019-05045-y']
341,30666700,Effects of the nitric oxide synthase inhibitor ronopterin (VAS203) on renal function in healthy volunteers.,"AIMS


Reduced nitric oxide (NO) availability may adversely affect renal perfusion and glomerular filtration. The aim of the present study was to characterize in detail the pharmacological effects of VAS203, an inhibitor of NO synthase, on renal haemodynamics in humans.
METHODS


This double-blind, randomized, placebo-controlled, cross-over phase-I-study comprised 18 healthy men. Renal haemodynamics were assessed with constant-infusion input-clearance technique with p-aminohippurate and inulin for renal plasma flow (RPF) and glomerular filtration rate (GFR), respectively. After baseline measurement, a constant infusion of the tetrahydrobiopterin analogue ronopterin (VAS203, total 10 mg/kg body weight) or placebo was administered at random order for 6 hours additionally. After a wash-out phase of 28 days, the second course was applied. In parallel, markers of early kidney injury and renal function were assessed repeatedly up to 48 hours after starting VAS203/placebo-infusion.
RESULTS


VAS203-infusion resulted in a significant decrease of RPF (P < .0001) and GFR (P < .001) compared to placebo, but magnitude was within the physiological range. RPF and GFR recovered partly 2 hours after end of VAS203-infusion and was normal at beginning of the second infusion period. Compared to placebo, preglomerular resistance (P < .0001), and to lesser extent postglomerular resistance (P < .0001) increased, resulting in a decrease of intraglomerular pressure (P < .01). No treatment related effect on markers of early kidney injury, and on renal function (P for all >.20) have been observed.
CONCLUSIONS


Our phase-I-study in healthy humans indicates that VAS203 (10 mg/kg body weight) reduces renal perfusion and glomerular function within the physiological range mainly due to vasoconstriction at the preglomerular site.",2019,"No treatment related effect on markers of early kidney injury, and on renal function (P for all >.20) have been observed.
","['healthy humans', 'humans', '18 healthy men', 'healthy volunteers']","['VAS203', 'nitric oxide synthase inhibitor ronopterin (VAS203', 'placebo']","['renal plasma flow (RPF) and glomerular filtration rate (GFR', 'intraglomerular pressure', 'Renal haemodynamics', 'markers of early kidney injury, and on renal function', 'renal perfusion and glomerular function', 'renal perfusion and glomerular filtration', 'GFR', 'renal function', 'RPF and GFR', 'early kidney injury and renal function', 'RPF']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4045572', 'cui_str': 'VAS203'}, {'cui': 'C0132555', 'cui_str': 'Nitric Oxide Synthase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0206087', 'cui_str': 'Renal Plasma Flow'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0232809', 'cui_str': 'Glomerular filtration, function (observable entity)'}]",18.0,0.370135,"No treatment related effect on markers of early kidney injury, and on renal function (P for all >.20) have been observed.
","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ott', 'Affiliation': 'Department of Nephrology and Hypertension, Friedrich-Alexander University Erlangen-Nürnberg, Germany.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Bosch', 'Affiliation': 'Department of Nephrology and Hypertension, Friedrich-Alexander University Erlangen-Nürnberg, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Winzer', 'Affiliation': 'Department of Nephrology and Hypertension, Friedrich-Alexander University Erlangen-Nürnberg, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Friedrich', 'Affiliation': 'Department of Nephrology and Hypertension, Friedrich-Alexander University Erlangen-Nürnberg, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Schinzel', 'Affiliation': 'vasopharm GmbH, Würzburg, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tegtmeier', 'Affiliation': 'vasopharm GmbH, Würzburg, Germany.'}, {'ForeName': 'Roland E', 'Initials': 'RE', 'LastName': 'Schmieder', 'Affiliation': 'Department of Nephrology and Hypertension, Friedrich-Alexander University Erlangen-Nürnberg, Germany.'}]",British journal of clinical pharmacology,['10.1111/bcp.13870']
342,31811662,Hypoglycaemia is reduced with use of inhaled Technosphere ®  Insulin relative to insulin aspart in type 1 diabetes mellitus.,"AIM


To evaluate the effect of final HbA 1c  levels on the incidences of hypoglycaemia in participants with type 1 diabetes treated with inhaled Technosphere ®  Insulin or subcutaneous insulin aspart, reported in alignment with the International Hypoglycaemia Study Group recommendations.
METHODS


In the randomized, phase 3, multicentre AFFINITY-1 study, adults (N = 375) who had type 1 diabetes for ≥ 12 months and an HbA 1c  level of 58-86 mmol/mol (7.5-10.0%) were randomized to receive basal insulin plus either inhaled Technosphere Insulin or subcutaneous insulin aspart. This was a post-hoc regression analysis on a subset (N = 279) of the randomized AFFINITY-1 cohort for whom baseline and end-of-treatment HbA 1c  values were reported. Primary outcome measures were incidence and event rates for levels 1, 2 and 3 hypoglycaemia, respectively defined as blood glucose levels of ≤ 3.9 mmol/l, < 3.0 mmol/l or requiring external assistance for recovery.
RESULTS


Participants treated with Technosphere Insulin experienced statistically significantly fewer level 1 and 2 hypoglycaemic events and a lower incidence of level 3 hypoglycaemia than participants treated with insulin aspart. The lower rate of hypoglycaemia with Technosphere Insulin was observed across the range of end-of-treatment HbA 1c  levels. Technosphere Insulin was associated with higher rates of hypoglycaemia 30-60 min after meals, but significantly lower rates 2-6 h after meals.
CONCLUSIONS


Participants using Technosphere Insulin experienced clinically non-inferior glycaemic control and lower hypoglycaemia rates across a range of HbA 1c  levels compared with participants receiving insulin aspart. ClinicalTrials.gov: NCT01445951.",2020,"Technosphere Insulin was associated with higher rates of hypoglycaemia 30-60 min after meals, but significantly lower rates 2-6 h after meals.
","['participants with type 1 diabetes treated with inhaled Technosphere ®  Insulin or subcutaneous insulin aspart, reported in alignment with the International Hypoglycaemia Study Group recommendations', 'adults (N\xa0=\xa0375) who had type 1 diabetes for ≥\xa012\xa0months and an HbA 1c  level of 58-86\xa0mmol/mol (7.5-10.0']","['final HbA 1c  levels', 'insulin aspart', 'basal insulin plus either inhaled Technosphere Insulin or subcutaneous insulin aspart']","['hypoglycaemia rates', 'level 1 and 2 hypoglycaemic events', 'level 3 hypoglycaemia', 'incidence and event rates for levels 1, 2 and 3 hypoglycaemia, respectively defined as blood glucose levels of ≤\xa03.9 mmol/l, <\xa03.0 mmol/l or requiring external assistance for recovery', 'Hypoglycaemia', 'rate of hypoglycaemia with Technosphere Insulin', 'hypoglycaemia']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517745', 'cui_str': '375 (qualifier value)'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0456949', 'cui_str': 'Level 3 (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]",,0.118406,"Technosphere Insulin was associated with higher rates of hypoglycaemia 30-60 min after meals, but significantly lower rates 2-6 h after meals.
","[{'ForeName': 'E R', 'Initials': 'ER', 'LastName': 'Seaquist', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Blonde', 'Affiliation': 'Ochsner Medical Center, New Orleans, LA, USA.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'McGill', 'Affiliation': 'Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Heller', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Kendall', 'Affiliation': 'MannKind Corporation, Westlake Village, CA, USA.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Bumpass', 'Affiliation': 'MannKind Corporation, Westlake Village, CA, USA.'}, {'ForeName': 'F M', 'Initials': 'FM', 'LastName': 'Pompilio', 'Affiliation': 'MannKind Corporation, Westlake Village, CA, USA.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Grant', 'Affiliation': 'MannKind Corporation, Westlake Village, CA, USA.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14202']
343,30737835,Effects of prednisone on docetaxel pharmacokinetics in men with metastatic prostate cancer: A randomized drug-drug interaction study.,"AIMS


Docetaxel has been approved for the treatment of metastatic prostate cancer in combination with prednisone. Since prednisone is known to induce the cytochrome P450 iso-enzyme CYP3A4, which is the main metabolizing enzyme of docetaxel in the liver, a potential drug-drug interaction may occur. In this prospective randomized pharmacokinetic cross-over study we investigated docetaxel exposure with concomitant prednisone, compared to docetaxel monotherapy in men with metastatic prostate cancer.
METHODS


Patients scheduled to receive at least 6 cycles of docetaxel (75 mg/m 2  ) and who gave written informed consent were randomized to receive either the 1 st  3 cycles, or the last 3 consecutive cycles with prednisone (twice daily 5 mg). Pharmacokinetic blood sampling was performed during cycle 3 and cycle 6. Primary endpoint was difference in docetaxel exposure, calculated as area under the curve (AUC 0-inf  ) and analysed by means of a linear mixed model. Given the cross-over design the study was powered on 18 patients to answer the primary, pharmacokinetic, endpoint.
RESULTS


Eighteen evaluable patients were included in the trial. Docetaxel concentration with concomitant prednisone (AUC 0-inf  2784 ng*h/mL, 95% confidence interval 2436-3183 ng*h/mL) was similar to the concentration of docetaxel monotherapy (AUC 0-inf  2647 ng*h/mL, 95% confidence interval 2377-2949 ng*h/mL). Exploratory analysis showed no toxicity differences between docetaxel monotherapy and docetaxel cycles with prednisone.
CONCLUSION


No significant difference in docetaxel concentrations was observed. In addition, we found similar toxicity profiles in absence and presence of prednisone. Therefore, from a pharmacokinetic point of view, docetaxel may be administrated with or without prednisone.",2019,"Docetaxel concentration with concomitant prednisone (AUC 0-inf  2784 ng*h/mL, 95% confidence interval 2436-3183 ng*h/mL) was similar to the concentration of docetaxel monotherapy (AUC 0-inf  2647 ng*h","['75\xa0mg/m 2  ) and who gave written informed consent', 'Eighteen evaluable patients were included in the trial', 'men with metastatic prostate cancer', 'Patients scheduled to receive at least 6\xa0cycles of']","['docetaxel monotherapy', 'docetaxel pharmacokinetics', 'docetaxel', 'prednisone', 'Docetaxel concentration with concomitant prednisone (AUC 0-inf  2784\xa0ng*h/mL', 'Docetaxel', 'docetaxel exposure with concomitant prednisone']","['docetaxel exposure, calculated as area under the curve (AUC 0-inf  ) and analysed by means of a linear mixed model', 'toxicity profiles', 'docetaxel concentrations', 'Pharmacokinetic blood sampling', 'toxicity differences']","[{'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1282496', 'cui_str': 'Metastasis from malignant tumor of prostate'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0005834', 'cui_str': 'Blood Specimen Collection'}]",18.0,0.0524274,"Docetaxel concentration with concomitant prednisone (AUC 0-inf  2784 ng*h/mL, 95% confidence interval 2436-3183 ng*h/mL) was similar to the concentration of docetaxel monotherapy (AUC 0-inf  2647 ng*h","[{'ForeName': 'Bodine P S', 'Initials': 'BPS', 'LastName': 'Belderbos', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Koen G A M', 'Initials': 'KGAM', 'LastName': 'Hussaarts', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Leonie J', 'Initials': 'LJ', 'LastName': 'van Harten', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Oomen-de Hoop', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'de Bruijn', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hamberg', 'Affiliation': 'Department of Internal Medicine, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'van Alphen', 'Affiliation': 'Department of Internal Medicine, Elisabeth Twee Steden Ziekenhuis, Tilburg, The Netherlands.'}, {'ForeName': 'Brigitte C M', 'Initials': 'BCM', 'LastName': 'Haberkorn', 'Affiliation': 'Department of Internal Medicine, Maasstad Ziekenhuis Rotterdam, The Netherlands.'}, {'ForeName': 'Martijn P', 'Initials': 'MP', 'LastName': 'Lolkema', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'de Wit', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'van Soest', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Ron H J', 'Initials': 'RHJ', 'LastName': 'Mathijssen', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}]",British journal of clinical pharmacology,['10.1111/bcp.13889']
344,30706508,"Evaluating metronidazole as a novel, safe CYP2A6 phenotyping probe in healthy adults.","AIMS


CYP2A6 is a genetically polymorphic enzyme resulting in differential substrate metabolism and health behaviours. Current phenotyping probes for CYP2A6 exhibit limitations related to procurement (deuterated cotinine), toxicity (coumarin), specificity (caffeine) and age-appropriate administration (nicotine, NIC). In vitro, CYP2A6 selectively forms 2-hydroxymetronidazole (2HM) from metronidazole (MTZ). The purpose of this study was to evaluate MTZ as a CYP2A6 phenotyping probe drug in healthy adults against the well-established method of measuring trans-3-hydroxycotinine (3HC)/cotinine (COT).
METHODS


A randomized, cross-over, pharmacokinetic study was completed in 16 healthy, nonsmoking adults. Separated by a washout period of at least 2 weeks, MTZ 500 mg and NIC gum 2 mg were administered and plasma was sampled over 48 hours and 8 hours, respectively. Correlations of plasma metabolite/parent ratios (2HM/MTZ; 3HC/COT) were assessed by Pearson coefficient. CYP2A6 genotyping was conducted and incorporated as a variable of plasma ratio response.
RESULTS


Correlations between the plasma ratio 2HM/MTZ and 3HC/COT were ≥ 0.9 at multiple time points (P < 0.001), demonstrating a wide window during which 2HM/MTZ can be queried post-MTZ dose. CYP2A6 genotype had significant impacts on both MTZ and NIC phenotyping ratios with decreased activity predicted phenotypes demonstrating 2HM/MTZ ratios ≤58% and 3HC/COT ratios ≤56% compared with extensive activity predicted phenotypes at all time points examined in the study (P < 0.05). No adverse events were reported in the MTZ arm while 38% (n = 6) of participants reported mild adverse events in the NIC arm.
CONCLUSIONS


Metronidazole via 2HM/MTZ performed well as a novel, safe phenotyping probe for CYP2A6 in healthy adults.",2019,"2HM/MTZ and 3HC/COT were ≥ 0.9 at multiple time points (P < 0.001), demonstrating a wide window during which 2HM/MTZ can be queried post-MTZ dose.","['16 healthy, nonsmoking adults', 'healthy adults']","['MTZ', 'metronidazole', 'metronidazole (MTZ', 'MTZ 500\xa0mg and NIC gum 2', 'Metronidazole via 2HM/MTZ', 'trans-3-hydroxycotinine (3HC)/cotinine (COT']","['plasma ratio', '2HM/MTZ and 3HC/COT', 'plasma metabolite/parent ratios (2HM/MTZ; 3HC/COT', 'adverse events', 'mild adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C1378701', 'cui_str': 'Gum (basic dose form)'}, {'cui': 'C0063125', 'cui_str': 'hydroxycotinine'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}]",,0.0269057,"2HM/MTZ and 3HC/COT were ≥ 0.9 at multiple time points (P < 0.001), demonstrating a wide window during which 2HM/MTZ can be queried post-MTZ dose.","[{'ForeName': 'Stephani L', 'Initials': 'SL', 'LastName': 'Stancil', 'Affiliation': ""Division of Adolescent Medicine, Children's Mercy Kansas City, MO, USA.""}, {'ForeName': 'Robin E', 'Initials': 'RE', 'LastName': 'Pearce', 'Affiliation': ""Division of Clinical Pharmacology, Toxicology and Therapeutic Innovation, Children's Mercy Kansas City, MO, USA.""}, {'ForeName': 'Rachel F', 'Initials': 'RF', 'LastName': 'Tyndale', 'Affiliation': 'Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Departments of Pharmacology & Toxicology, and Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Kearns', 'Affiliation': ""Arkansas Children's Research Institute and the Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.""}, {'ForeName': 'Carrie A', 'Initials': 'CA', 'LastName': 'Vyhlidal', 'Affiliation': ""Division of Clinical Pharmacology, Toxicology and Therapeutic Innovation, Children's Mercy Kansas City, MO, USA.""}, {'ForeName': 'J Steven', 'Initials': 'JS', 'LastName': 'Leeder', 'Affiliation': ""Division of Clinical Pharmacology, Toxicology and Therapeutic Innovation, Children's Mercy Kansas City, MO, USA.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Abdel-Rahman', 'Affiliation': ""Division of Clinical Pharmacology, Toxicology and Therapeutic Innovation, Children's Mercy Kansas City, MO, USA.""}]",British journal of clinical pharmacology,['10.1111/bcp.13884']
345,30710391,"Central nervous system effects of the histamine-3 receptor antagonist CEP-26401, in comparison with modafinil and donepezil, after a single dose in a cross-over study in healthy volunteers.","AIMS


In previous studies, the histamine-3 receptor antagonist CEP-26401 had a subtle effect on spatial working memory, with the best effect seen at the lowest dose tested (20 μg), and a dose-dependent disruption of sleep. In the current study, 3 low-dose levels of CEP-26401 were compared with modafinil and donepezil.
METHODS


In this double-blind, placebo- and positive-controlled, randomized, partial 6-way cross-over study, 40 healthy subjects received single doses of placebo, CEP-26401 (5, 25 or 125 μg) or modafinil 200 mg or donepezil 10 mg. Pharmacokinetic and pharmacodynamic measurements were performed predose and at designated time points postdose.
RESULTS


The main endpoint between-errors of the spatial working memory-10-boxes task only improved for the 125 μg dose of CEP-26401 with a difference of 2.92 (confidence interval [CI] -1.21 to 7.05), 3.24 (CI -1.57 to 8.04) and 7.45 (CI 2.72 to 12.19) for respectively the 5, 25 and 125 μg dose of CEP-26401, -1.65 (CI -0.572 to 1.96) for modafinil and - 3.55 (CI -7.13 to 0.03) for donepezil. CEP-26401 induced an improvement of adaptive tracking, saccadic peak velocity and reaction time during N-back, but a dose-related inhibition of sleep and slight worsening of several cognitive parameters at the highest dose. CEP-26401 significantly changed several subjective visual analogue scales, which was strongest at 25 μg, causing the same energizing and happy feeling as modafinil, but with a more relaxed undertone.
DISCUSSION


Of the doses tested, the 25 μg dose of CEP-26401 had the most optimal balance between favourable subjective effects and sleep inhibition. Whether CEP-26401 can have beneficial effects in clinical practice remains to be studied.",2019,"CEP-26401 induced an improvement of adaptive tracking, saccadic peak velocity and reaction time during N-back, but a dose-related inhibition of sleep and slight worsening of several cognitive parameters at the highest dose.","['healthy volunteers', '40 healthy subjects']","['modafinil and donepezil', 'placebo', 'donepezil', 'modafinil 200\xa0mg or donepezil 10\xa0mg', 'histamine-3 receptor antagonist CEP-26401', 'CEP-26401', 'placebo, CEP-26401']","['errors of the spatial working memory-10-boxes task', 'adaptive tracking, saccadic peak velocity and reaction time during N-back, but a dose-related inhibition of sleep and slight worsening of several cognitive parameters', 'several subjective visual analogue scales', 'Pharmacokinetic and pharmacodynamic measurements', 'spatial working memory']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0066677', 'cui_str': 'modafinil'}, {'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0987900', 'cui_str': 'modafinil 200 MG'}, {'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C3254381', 'cui_str': 'CEP-26401'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2937276', 'cui_str': 'Slight (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]",40.0,0.462805,"CEP-26401 induced an improvement of adaptive tracking, saccadic peak velocity and reaction time during N-back, but a dose-related inhibition of sleep and slight worsening of several cognitive parameters at the highest dose.","[{'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Baakman', 'Affiliation': 'Centre for Human Drug Research, Leiden, Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Zuiker', 'Affiliation': 'Centre for Human Drug Research, Leiden, Netherlands.'}, {'ForeName': 'Joop M A', 'Initials': 'JMA', 'LastName': 'van Gerven', 'Affiliation': 'Centre for Human Drug Research, Leiden, Netherlands.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Gross', 'Affiliation': 'Research and Development Teva Pharmaceuticals, Frazer, Philadelphia, USA.'}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Research and Development Teva Pharmaceuticals, Frazer, Philadelphia, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fetell', 'Affiliation': 'Research and Development Teva Pharmaceuticals, Frazer, Philadelphia, USA.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Gershon', 'Affiliation': 'Global Patient Safety and Pharmacovigilance, Teva Pharmaceuticals, Petah Tikva, Israel.'}, {'ForeName': 'Yossi', 'Initials': 'Y', 'LastName': 'Gilgun-Sherki', 'Affiliation': 'Formerly Research and Development Teva Pharmaceuticals, Netanya, Israel.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Hellriegel', 'Affiliation': 'Research and Development Teva Pharmaceuticals, West Chester, Pennsylvania, USA.'}, {'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Spiegelstein', 'Affiliation': 'Research and Development Teva Pharmaceuticals, Netanya, Israel.'}]",British journal of clinical pharmacology,['10.1111/bcp.13885']
346,31012040,"A Randomized, Placebo-Controlled, Double-Blind Study that Evaluates Efficacy of Intravenous Ibuprofen and Acetaminophen for Postoperative Pain Treatment Following Laparoscopic Cholecystectomy Surgery.","BACKGROUND


Ibuprofen is a NSAID that has anti-inflammatory, antipyretic, and analgesic effects. The oral form of the drug has been used safely for a long time and is one of the most preferred NSAIDs. It has been shown that ibuprofen is effective in the treatment of postoperative pain; however, there have not been sufficient studies on ibuprofen. We evaluated and compared the influence of IV forms of ibuprofen and acetaminophen on pain management and opioid consumption on patients undergoing laparoscopic cholecystectomy surgery.
METHODS


Patients were stratified into three groups. Group I (group ibuprofen, n = 30) was administered 800 mg of IV ibuprofen; group A (group acetaminophen, n = 30) was administered 1000 mg of IV acetaminophen; and group C (control group, n = 30) was given 100 ml of saline solution. We evaluated opioid consumption and VAS scores postoperatively.
RESULTS


Pain scores in group I and group A at all time periods were lower than those in group C (p < 0.05). Group I had significantly lower VAS scores than those in group A at all time periods postoperatively (p < 0.05). Those in group C had significantly higher opioid consumption than the other groups (p < 0.05). Opioid consumption in group I at all time periods postoperatively was significantly lower than those in group A (p < 0.05). Group I had statistically lower rescue medication than the other groups at all time periods.
CONCLUSION


Our study suggested that IV ibuprofen resulted in lower pain scores and reduced opioid use compared with acetaminophen postoperatively in the first 24 h in patients undergoing laparoscopic cholecystectomy surgery.",2020,Group I had significantly lower VAS scores than those in group A at all time periods postoperatively (p < 0.05).,"['Patients were stratified into three groups', 'patients undergoing laparoscopic cholecystectomy surgery', 'Laparoscopic Cholecystectomy Surgery']","['ibuprofen and acetaminophen', 'ibuprofen', 'Placebo', 'Opioid consumption', 'Ibuprofen and Acetaminophen', 'ibuprofen, n\u2009=\u200930) was administered 800\xa0mg of IV ibuprofen', 'acetaminophen', 'Ibuprofen', 'acetaminophen, n\u2009=\u200930) was administered 1000\xa0mg of IV acetaminophen; and group C (control group, n\u2009=\u200930) was given 100\xa0ml of saline solution']","['opioid consumption', 'pain management and opioid consumption', 'lower pain scores', 'Pain scores', 'VAS scores', 'rescue medication', 'opioid consumption and VAS scores postoperatively']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0465028,Group I had significantly lower VAS scores than those in group A at all time periods postoperatively (p < 0.05).,"[{'ForeName': 'Mursel', 'Initials': 'M', 'LastName': 'Ekinci', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, Bagcilar, 34000, Istanbul, Turkey.'}, {'ForeName': 'Bahadır', 'Initials': 'B', 'LastName': 'Ciftci', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, Bagcilar, 34000, Istanbul, Turkey. bciftci@medipol.edu.tr.'}, {'ForeName': 'Erkan Cem', 'Initials': 'EC', 'LastName': 'Celik', 'Affiliation': 'Department of Anesthesiology and Reanimation, Erzurum Regional Training and Research Hospital, Yakutiye, 25070, Erzurum, Turkey.'}, {'ForeName': 'Emine Arzu', 'Initials': 'EA', 'LastName': 'Köse', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, Bagcilar, 34000, Istanbul, Turkey.'}, {'ForeName': 'Muhammet Ahmet', 'Initials': 'MA', 'LastName': 'Karakaya', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, Bagcilar, 34000, Istanbul, Turkey.'}, {'ForeName': 'Yasar', 'Initials': 'Y', 'LastName': 'Ozdenkaya', 'Affiliation': 'Department of General Surgery, Istanbul Medipol University, Bagcilar, 34000, Istanbul, Turkey.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-019-04220-1']
347,31066013,"A Multicenter, Randomized, Open-Label Study to Compare Micafungin with Fluconazole in the Prophylaxis of Invasive Fungal Infections in Living-Donor Liver Transplant Recipients.","BACKGROUND


Although invasive fungal infections (IFIs) contribute to substantial morbidity and mortality in liver transplant recipients, only a few randomized studies analyzed the results of antifungal prophylaxis with echinocandins. The aim of this open-label, non-inferiority study was to evaluate the efficacy and safety of micafungin in the prophylaxis of IFIs in living-donor liver transplantation recipients (LDLTRs), with fluconazole as the comparator.
METHODS


LDLTRs (N = 172) from five centers were randomized 1:1 to receive intravenous micafungin 100 mg/day or fluconazole 100~200 mg/day (intravenous or oral). A non-inferiority of micafungin was tested against fluconazole.
RESULTS


The per-protocol set included 144 patients without major clinical trial protocol violations: 69 from the micafungin group and 75 from the fluconazole group. Mean age of the study patients was 54.2 years and mean model for end-stage liver disease (MELD) score amounted to 16.5. Clinical success rates in the micafungin and fluconazole groups were 95.65% and 96.10%, respectively (difference: - 0.45%; 90% confidence interval [CI]: - 6.93%, 5.59%), which demonstrated micafungin's non-inferiority (the lower bound for the 90% CI exceeded - 10%). The study groups did not differ significantly in terms of the secondary efficacy endpoints: absence of IFIs at the end of the prophylaxis and the end of the study, time to proven IFI, fungal-free survival, and adverse reactions. A total of 17 drug-related adverse events were observed in both groups; none of them was serious and all resolved.
CONCLUSION


Micafungin can be used as an alternative to fluconazole in the prevention of IFIs in LDLTRs.
CLINICAL TRIALS REGISTRATION


NCT01974375.",2020,"A total of 17 drug-related adverse events were observed in both groups; none of them was serious and all resolved.
","['Mean age of the study patients was 54.2\xa0years and mean model for end-stage liver disease (MELD) score amounted to 16.5', 'LDLTRs (N\u2009=\u2009172) from five centers', 'Living-Donor Liver Transplant Recipients', '144 patients without major clinical trial protocol violations: 69 from the micafungin group and 75 from the fluconazole group', 'living-donor liver transplantation recipients (LDLTRs', 'liver transplant recipients']","['intravenous micafungin 100\xa0mg/day or fluconazole 100~200\xa0mg/day (intravenous or oral', 'Micafungin with Fluconazole', 'micafungin', 'Micafungin', 'fluconazole']","['adverse events', 'secondary efficacy endpoints: absence of IFIs at the end of the prophylaxis and the end of the study, time to proven IFI, fungal-free survival, and adverse reactions', 'Clinical success rates', 'efficacy and safety']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517808', 'cui_str': '54.2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4048785', 'cui_str': 'MELD score'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C3544287', 'cui_str': 'Living donor liver transplant'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2599718', 'cui_str': 'Trial Protocols'}, {'cui': 'C1120386', 'cui_str': 'micafungin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0348050', 'cui_str': 'Living Donors'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C3811922', 'cui_str': 'Transplanted liver present (finding)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1120386', 'cui_str': 'micafungin'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",144.0,0.0550284,"A total of 17 drug-related adverse events were observed in both groups; none of them was serious and all resolved.
","[{'ForeName': 'Woo-Hyoung', 'Initials': 'WH', 'LastName': 'Kang', 'Affiliation': 'Division of Liver Transplantation and Hepatobiliary Surgery, Department of Surgery, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, South Korea.'}, {'ForeName': 'Gi-Won', 'Initials': 'GW', 'LastName': 'Song', 'Affiliation': 'Division of Liver Transplantation and Hepatobiliary Surgery, Department of Surgery, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, South Korea. drsong71@amc.seoul.kr.'}, {'ForeName': 'Sung-Gyu', 'Initials': 'SG', 'LastName': 'Lee', 'Affiliation': 'Division of Liver Transplantation and Hepatobiliary Surgery, Department of Surgery, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, South Korea.'}, {'ForeName': 'Kyung-Suk', 'Initials': 'KS', 'LastName': 'Suh', 'Affiliation': 'Department of Surgery, College of Medicine, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Kwang-Woong', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, College of Medicine, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Nam-Joon', 'Initials': 'NJ', 'LastName': 'Yi', 'Affiliation': 'Department of Surgery, College of Medicine, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Jae Won', 'Initials': 'JW', 'LastName': 'Joh', 'Affiliation': 'Department of Surgery, Samsung Medical Center, School of Medicine, Sungkyunkwan University, Seoul, South Korea.'}, {'ForeName': 'Choon Hyuck David', 'Initials': 'CHD', 'LastName': 'Kwon', 'Affiliation': 'Department of Surgery and Digestive Disease Institute, Cleveland Clinic, Cleveland Clinic Lerner College of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Jong Man', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Samsung Medical Center, School of Medicine, Sungkyunkwan University, Seoul, South Korea.'}, {'ForeName': 'Dong Lak', 'Initials': 'DL', 'LastName': 'Choi', 'Affiliation': 'Department of Surgery, College of Medicine, Catholic University of Daegu, Daegu, South Korea.'}, {'ForeName': 'Joo Dong', 'Initials': 'JD', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, College of Medicine, Catholic University of Daegu, Daegu, South Korea.'}, {'ForeName': 'Myoung Soo', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, College of Medicine, Yonsei University, Seoul, South Korea.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-019-04241-w']
348,32208487,Phase 2 trial of montelukast for prevention of pain in sickle cell disease.,"Cysteinyl leukotrienes (CysLTs) are lipid mediators of inflammation. In patients with sickle cell disease (SCD), levels of CysLTs are increased compared with controls and associated with a higher rate of hospitalization for pain. We tested the hypothesis that administration of the CysLT receptor antagonist montelukast would improve SCD-related comorbidities, including pain, in adolescents and adults with SCD. In a phase 2 randomized trial, we administered montelukast or placebo for 8 weeks. The primary outcome measure was a >30% reduction in soluble vascular cell adhesion molecule 1 (sVCAM), a marker of vascular injury. Secondary outcome measures were reduction in daily pain, improvement in pulmonary function, and improvement in microvascular blood flow, as measured by laser Doppler velocimetry. Forty-two participants with SCD were randomized to receive montelukast or placebo for 8 weeks. We found no difference between the montelukast and placebo groups with regard to the levels of sVCAM, reported pain, pulmonary function, or microvascular blood flow. Although montelukast is an effective treatment for asthma, we did not find benefit for SCD-related outcomes. This clinical trial was registered at www.clinicaltrials.gov as #NCT01960413.",2020,"We found no difference between the montelukast and placebo groups with regard to the levels of sVCAM, reported pain, pulmonary function, or microvascular blood flow.","['patients with sickle cell disease (SCD', 'Forty-two participants with SCD', 'sickle cell disease', 'adolescents and adults with SCD']","['montelukast', 'CysLT receptor antagonist montelukast', 'placebo', 'montelukast or placebo']","['levels of sVCAM, reported pain, pulmonary function, or microvascular blood flow', 'reduction in daily pain, improvement in pulmonary function, and improvement in microvascular blood flow, as measured by laser Doppler velocimetry', 'soluble vascular cell adhesion molecule 1 (sVCAM), a marker of vascular injury', 'rate of hospitalization for pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0298130', 'cui_str': 'montelukast'}, {'cui': 'C0125642', 'cui_str': 'LTD4 receptor'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0162462', 'cui_str': 'Velocimetry'}, {'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}, {'cui': 'C0178324', 'cui_str': 'Vascular Injuries'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",42.0,0.530257,"We found no difference between the montelukast and placebo groups with regard to the levels of sVCAM, reported pain, pulmonary function, or microvascular blood flow.","[{'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Field', 'Affiliation': 'Medical Sciences Institute, Versiti Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Adetola', 'Initials': 'A', 'LastName': 'Kassim', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Brandow', 'Affiliation': 'Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Stephen H', 'Initials': 'SH', 'LastName': 'Embury', 'Affiliation': 'Vanguard Therapeutics, Inc., Half Moon Bay, CA; and.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Matsui', 'Affiliation': 'Vanguard Therapeutics, Inc., Half Moon Bay, CA; and.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Wilkerson', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Valencia', 'Initials': 'V', 'LastName': 'Bryant', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Liyun', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Pippa', 'Initials': 'P', 'LastName': 'Simpson', 'Affiliation': 'Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'DeBaun', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN.'}]",Blood advances,['10.1182/bloodadvances.2019001165']
349,30414797,Effect of Intravascular Cooling on Microvascular Obstruction (MVO) in Conscious Patients with ST-Elevation Myocardial Infarction Undergoing Primary PCI: Results from the COOL AMI EU Pilot Study.,"OBJECTIVE


COOL AMI EU pilot was a multi-center, randomized controlled trial to assess feasibility and safety of rapid intravascular therapeutic hypothermia (TH) in conscious patients with anterior ST-elevation myocardial infarction (STEMI) undergoing primary PCI (PPCI). We report the effect of hypothermia upon microvascular obstruction (MVO).
METHODS


Conscious patients with anterior STEMI and symptom duration <6 h were recruited and randomized to PPCI + TH or PPCI alone. TH was induced using the ZOLL® Proteus™ intravascular temperature management system and rapid infusion of 1 L of cold normal saline, with a target temperature of 32 °C. MVO was measured by cardiac magnetic resonance (CMR) at 4 to 6 days post-MI. MVO larger than 3.9% of LV was considered as extensive MVO.
RESULTS


50 patients were randomized; mean age was 58 years, and 86% were men. At reperfusion, mean intravascular temperature for the TH group was 33.6 ± 1 °C. The presence of MVO was high and not different in both groups (74% vs. 77%, p = 0.79). The proportion of patients with extensive MVO was 11% in the TH group and 23% in the control group (OR 0.4 95%CI 0.07-2.35, p = 0.30). Patients with extensive MVO showed reduced EF at 4-6 days (34% versus 43%, p = 0.01). The percentage of patients with EF <35% at 30 days was 6% in the TH group versus 24% in the control group (p = 0.19).
CONCLUSION


In the COOL-AMI Pilot Trial, the presence of MVO in both test groups was high and extensive MVO was related with reduced LVEF. The efficacy of therapeutic hypothermia (TH) in MVO reduction should be tested in a pivotal trial.",2019,"Patients with extensive MVO showed reduced EF at 4-6 days (34% versus 43%, p = 0.01).","['conscious patients with ST-elevation myocardial infarction undergoing primary PCI', 'conscious patients with anterior ST-elevation myocardial infarction (STEMI) undergoing primary PCI (PPCI', 'Conscious patients with anterior STEMI and symptom duration <6\u202fh', '50 patients were randomized; mean age was 58\u202fyears, and 86% were men']","['hypothermia', 'PPCI\u202f+\u202fTH or PPCI alone', 'therapeutic hypothermia (TH', 'intravascular cooling', 'rapid intravascular therapeutic hypothermia (TH']","['mean intravascular temperature', 'cardiac magnetic resonance (CMR', 'presence of MVO', 'reduced EF', 'proportion of patients with extensive MVO', 'MVO', 'microvascular obstruction (MVO']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0020674', 'cui_str': 'Targeted Temperature Management'}, {'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]",50.0,0.113306,"Patients with extensive MVO showed reduced EF at 4-6 days (34% versus 43%, p = 0.01).","[{'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Keeble', 'Affiliation': 'Department of Cardiology, Essex Cardiothoracic Centre, Basildon & Anglia Ruskin School of Medicine, Chelmsford, UK. Electronic address: Thomas.keeble@btuh.nhs.uk.'}, {'ForeName': 'Grigoris V', 'Initials': 'GV', 'LastName': 'Karamasis', 'Affiliation': 'Department of Cardiology, Essex Cardiothoracic Centre, Basildon & Anglia Ruskin School of Medicine, Chelmsford, UK.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Noc', 'Affiliation': 'University Medical Center Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Sredniawa', 'Affiliation': 'Department of Cardiology, Silesian Center for Heart Diseases, Medical University of Silesia, SMDZ, Zabrze, Poland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Aradi', 'Affiliation': 'Heart Center Balatonfüred, Hungary.'}, {'ForeName': 'Aleksandar N', 'Initials': 'AN', 'LastName': 'Neskovic', 'Affiliation': 'Clinical Hospital Center Zemun, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Arheden', 'Affiliation': 'Department of Clinical Physiology, Skane University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erlinge', 'Affiliation': 'Department of Cardiology, Skane University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Holzer', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.'}]",Cardiovascular revascularization medicine : including molecular interventions,['10.1016/j.carrev.2018.09.014']
350,29368802,Dietary nitrate-induced increases in human muscle power: high versus low responders.,"Maximal neuromuscular power is an important determinant of athletic performance and also quality of life, independence, and perhaps even mortality in patient populations. We have shown that dietary nitrate (NO 3 -  ), a source of nitric oxide (NO), improves muscle power in some, but not all, subjects. The present investigation was designed to identify factors contributing to this interindividual variability. Healthy men (n = 13) and women (n = 7) 22-79 year of age and weighing 52.1-114.9 kg were studied using a randomized, double-blind, placebo-controlled, crossover design. Subjects were tested 2 h after ingesting beetroot juice (BRJ) either containing or devoid of 12.3 ± 0.8 mmol of NO 3 -  . Plasma NO 3 -  and nitrite (NO 2 -  ) were measured as indicators of NO bioavailability and maximal knee extensor speed (V max  ), power (P max  ), and fatigability were determined via isokinetic dynamometry. On average, dietary NO 3 -  increased (P < 0.05) P max  by 4.4 ± 8.1%. Individual changes, however, ranged from -9.6 to +26.8%. This interindividual variability was not significantly correlated with age, body mass (inverse of NO 3 -  dose per kg), body mass index (surrogate for body composition) or placebo trial V max  or fatigue index (in vivo indicators of muscle fiber type distribution). In contrast, the relative increase in Pmax was significantly correlated (r = 0.60; P < 0.01) with the relative increase in plasma NO 2 -  concentration. In multivariable analysis female sex also tended (P = 0.08) to be associated with a greater increase in Pmax. We conclude that the magnitude of the dietary NO 3 -  -induced increase in muscle power is dependent upon the magnitude of the resulting increase in plasma NO 2 -  and possibly female sex.",2018,"On average, dietary NO 3 -  increased (P < 0.05) P max  by 4.4 ± 8.1%.",['Healthy men (n\xa0=\xa013) and women (n\xa0=\xa07) 22-79\xa0year of age and weighing 52.1-114.9\xa0kg'],"['ingesting beetroot juice (BRJ) either containing or devoid of 12.3\xa0±\xa00.8\xa0mmol of NO 3 -  ', 'placebo']","['human muscle power', 'Plasma', 'indicators of NO bioavailability and maximal knee extensor speed (V max  ), power (P max  ), and fatigability were determined via isokinetic dynamometry', 'Pmax']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]","[{'cui': 'C0453112', 'cui_str': 'Beetroot (substance)'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0231230', 'cui_str': 'Fatigability (finding)'}]",,0.0601184,"On average, dietary NO 3 -  increased (P < 0.05) P max  by 4.4 ± 8.1%.","[{'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Coggan', 'Affiliation': 'Departments of Kinesiology, Indiana University Purdue University Indianapolis, Indianapolis, Indiana.'}, {'ForeName': 'Seth R', 'Initials': 'SR', 'LastName': 'Broadstreet', 'Affiliation': 'Departments of Kinesiology, Indiana University Purdue University Indianapolis, Indianapolis, Indiana.'}, {'ForeName': 'Deana', 'Initials': 'D', 'LastName': 'Mikhalkova', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Indra', 'Initials': 'I', 'LastName': 'Bole', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Leibowitz', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Kadkhodayan', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Soo', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Deepak P', 'Initials': 'DP', 'LastName': 'Thomas', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Dakkota', 'Initials': 'D', 'LastName': 'Thies', 'Affiliation': 'Departments of Radiology, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Peterson', 'Affiliation': 'Departments of Radiology, Washington University School of Medicine, St. Louis, Missouri.'}]",Physiological reports,['10.14814/phy2.13575']
351,29789395,Blood Pressure-Attained Analysis of ATACH 2 Trial.,"BACKGROUND AND PURPOSE


We compared the rates of death or disability, defined by modified Rankin Scale score of 4 to 6, at 3 months in patients with intracerebral hemorrhage according to post-treatment systolic blood pressure (SBP)-attained status.
METHODS


We divided 1000 subjects with SBP ≥180 mm Hg who were randomized within 4.5 hours of symptom onset as follows: SBP <140 mm Hg achieved or not achieved within 2 hours; subjects in whom SBP <140 mm Hg was achieved within 2 hours were further divided: SBP <140 mm Hg for 21 to 22 hours (reduced and maintained) or SBP was ≥140 mm Hg for at least 2 hours during the period between 2 and 24 hours (reduced but not maintained).
RESULTS


Compared with subjects without reduction of SBP <140 mm Hg within 2 hours, subjects with reduction and maintenance of SBP <140 mm Hg within 2 hours had a similar rate of death or disability (relative risk of 0.98; 95% confidence interval, 0.74-1.29). The rates of neurological deterioration within 24 hours were significantly higher in reduced and maintained group (10.4%; relative risk, 1.98; 95% confidence interval, 1.08-3.62) and in reduced but not maintained group (11.5%; relative risk, 2.08; 95% confidence interval, 1.15-3.75) compared with reference group. The rates of cardiac-related adverse events within 7 days were higher among subjects with reduction and maintenance of SBP <140 mmHg compared to subjects without reduction (11.2% versus 6.4%).
CONCLUSIONS


No decline in death or disability but higher rates of neurological deterioration and cardiac-related adverse events were observed among intracerebral hemorrhage subjects with reduction with and without maintenance of intensive SBP goals.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT01176565.",2018,"No decline in death or disability but higher rates of neurological deterioration and cardiac-related adverse events were observed among intracerebral hemorrhage subjects with reduction with and without maintenance of intensive SBP goals.
","['patients with intracerebral hemorrhage according to post-treatment systolic blood pressure (SBP)-attained status', '1000 subjects with SBP ≥180 mm\u2009Hg who were randomized within 4.5 hours of symptom onset as follows: SBP <140 mm']",[],"['death or disability', 'neurological deterioration and cardiac-related adverse events', 'rate of death or disability', 'rates of neurological deterioration', 'rates of cardiac-related adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}]",[],"[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1000.0,0.136696,"No decline in death or disability but higher rates of neurological deterioration and cardiac-related adverse events were observed among intracerebral hemorrhage subjects with reduction with and without maintenance of intensive SBP goals.
","[{'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'From the Department of Neurology, Zeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis (A.I.Q., M.H.Q.) qureshai@gmail.com.'}, {'ForeName': 'Yuko Y', 'Initials': 'YY', 'LastName': 'Palesch', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston (Y.Y.P., L.D.F.).'}, {'ForeName': 'Lydia D', 'Initials': 'LD', 'LastName': 'Foster', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston (Y.Y.P., L.D.F.).'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Barsan', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor (W.G.B., R.S.).'}, {'ForeName': 'Joshua N', 'Initials': 'JN', 'LastName': 'Goldstein', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston (J.N.G.).'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hanley', 'Affiliation': 'Department of Neurology, Johns Hopkins University, Baltimore, MD (D.F.H.).'}, {'ForeName': 'Chung Y', 'Initials': 'CY', 'LastName': 'Hsu', 'Affiliation': 'Department of Neurology, China Medical University, Taichung, Taiwan (C.Y.H.).'}, {'ForeName': 'Claudia S', 'Initials': 'CS', 'LastName': 'Moy', 'Affiliation': 'Division of Clinical Research, National Institutes of Health, Bethesda, MD (C.S.M.).'}, {'ForeName': 'Mushtaq H', 'Initials': 'MH', 'LastName': 'Qureshi', 'Affiliation': 'From the Department of Neurology, Zeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis (A.I.Q., M.H.Q.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Silbergleit', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor (W.G.B., R.S.).'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Suarez', 'Affiliation': 'Department of Neurology, Baylor College of Medicine, Houston, TX (J.I.S.).'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'Department of Neurology, National Cerebral and Cardiovascular Center, Suita, Japan (K.T., H.Y.).'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Neurology, National Cerebral and Cardiovascular Center, Suita, Japan (K.T., H.Y.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.117.019845']
352,30017006,The effectiveness and cost-effectiveness of the Incredible Years® Teacher Classroom Management programme in primary school children: results of the STARS cluster randomised controlled trial.,"BACKGROUND


We evaluated the effectiveness and cost-effectiveness of the Incredible Years® Teacher Classroom Management (TCM) programme as a universal intervention, given schools' important influence on child mental health.
METHODS


A two-arm, pragmatic, parallel group, superiority, cluster randomised controlled trial recruited three cohorts of schools (clusters) between 2012 and 2014, randomising them to TCM (intervention) or Teaching As Usual (TAU-control). TCM was delivered to teachers in six whole-day sessions, spread over 6 months. Schools and teachers were not masked to allocation. The primary outcome was teacher-reported Strengths and Difficulties Questionnaire (SDQ) Total Difficulties score. Random effects linear regression and marginal logistic regression models using Generalised Estimating Equations were used to analyse the outcomes.
TRIAL REGISTRATION


ISRCTN84130388.
RESULTS


Eighty schools (2075 children) were enrolled; 40 (1037 children) to TCM and 40 (1038 children) to TAU. Outcome data were collected at 9, 18, and 30-months for 96, 89, and 85% of children, respectively. The intervention reduced the SDQ-Total Difficulties score at 9 months (mean (s.d.):5.5 (5.4) in TCM v. 6.2 (6.2) in TAU; adjusted mean difference = -1.0; 95% CI-1.9 to -0.1; p = 0.03) but this did not persist at 18 or 30 months. Cost-effectiveness analysis suggested that TCM may be cost-effective compared with TAU at 30-months, but this result was associated with uncertainty so no firm conclusions can be drawn. A priori subgroup analyses suggested TCM is more effective for children with poor mental health.
CONCLUSIONS


TCM provided a small, short-term improvement to children's mental health particularly for children who are already struggling.",2019,The intervention reduced the SDQ-Total Difficulties score at 9 months (mean (s.d.):5.5 (5.4) in TCM v. 6.2 (6.2) in TAU; adjusted mean difference = -1.0; 95% CI-1.9 to -0.1; p = 0.03) but this did not persist at 18 or 30 months.,"['A two-arm, pragmatic, parallel group, superiority, cluster randomised controlled trial recruited three cohorts of schools (clusters) between 2012 and 2014, randomising them to TCM (intervention) or Teaching', 'primary school children', 'children with poor mental health', ""children's mental health particularly for children who are already struggling"", 'Eighty schools (2075 children) were enrolled; 40 (1037 children) to TCM and 40 (1038 children) to TAU']","['Incredible Years® Teacher Classroom Management (TCM) programme', 'TCM', 'Incredible Years® Teacher Classroom Management programme']","['SDQ-Total Difficulties score', 'teacher-reported Strengths and Difficulties Questionnaire (SDQ) Total Difficulties score', 'effectiveness and cost-effectiveness']","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire (assessment scale)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",2075.0,0.246334,The intervention reduced the SDQ-Total Difficulties score at 9 months (mean (s.d.):5.5 (5.4) in TCM v. 6.2 (6.2) in TAU; adjusted mean difference = -1.0; 95% CI-1.9 to -0.1; p = 0.03) but this did not persist at 18 or 30 months.,"[{'ForeName': 'Tamsin', 'Initials': 'T', 'LastName': 'Ford', 'Affiliation': ""University of Exeter Medical School,South Cloisters,St Luke's Campus,Exeter, EX1 2LU,UK.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hayes', 'Affiliation': ""University of Exeter Medical School,South Cloisters,St Luke's Campus,Exeter, EX1 2LU,UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Byford', 'Affiliation': ""King's College London,King's Health Economics,Box PO24,Institute of Psychiatry, Psychology & Neuroscience,De Crespigny Park,London, SE5 8AF,UK.""}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Edwards', 'Affiliation': ""University of Exeter Medical School,South Cloisters,St Luke's Campus,Exeter, EX1 2LU,UK.""}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Fletcher', 'Affiliation': ""University of Exeter Medical School,South Cloisters,St Luke's Campus,Exeter, EX1 2LU,UK.""}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Logan', 'Affiliation': ""University of Exeter Medical School,South Cloisters,St Luke's Campus,Exeter, EX1 2LU,UK.""}, {'ForeName': 'Brahm', 'Initials': 'B', 'LastName': 'Norwich', 'Affiliation': ""Graduate School of Education,University of Exeter,North Cloisters,St Luke's Campus,Exeter, EX1 2LU,UK.""}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Pritchard', 'Affiliation': 'Education and Early Years,Cornwall County Council,3 West,New County Hall,Treyew Road,Truro, TR1 3AY Truro,TR1 3AY,UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Allen', 'Affiliation': ""University of Exeter Medical School,South Cloisters,St Luke's Campus,Exeter, EX1 2LU,UK.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Allwood', 'Affiliation': ""University of Exeter Medical School,South Cloisters,St Luke's Campus,Exeter, EX1 2LU,UK.""}, {'ForeName': 'Poushali', 'Initials': 'P', 'LastName': 'Ganguli', 'Affiliation': ""King's College London,King's Health Economics,Box PO24,Institute of Psychiatry, Psychology & Neuroscience,De Crespigny Park,London, SE5 8AF,UK.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Grimes', 'Affiliation': 'Educational and Counselling Psychology and Special Education,University of British Columbia,2125 Main Mall,Vancouver,British Columbia,Canada,V6T 1Z4,Canada.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Hansford', 'Affiliation': ""University of Exeter Medical School,South Cloisters,St Luke's Campus,Exeter, EX1 2LU,UK.""}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Longdon', 'Affiliation': ""University of Exeter Medical School,South Cloisters,St Luke's Campus,Exeter, EX1 2LU,UK.""}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Norman', 'Affiliation': 'University of Exeter,Sir Henry Wellcome Building,Streatham campus,University of Exeter,EX4 4QG,UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Price', 'Affiliation': ""University of Exeter Medical School,South Cloisters,St Luke's Campus,Exeter, EX1 2LU,UK.""}, {'ForeName': 'Obioha C', 'Initials': 'OC', 'LastName': 'Ukoumunne', 'Affiliation': ""NIHR CLAHRC South West Peninsula (PenCLAHRC), University of Exeter,South Cloisters,St Luke's Campus,Exeter, EX1 2LU,UK.""}]",Psychological medicine,['10.1017/S0033291718001484']
353,30553816,Comparison of Hemostasis Times with a Chitosan-Based Hemostatic Pad (Clo-Sur Plus  Radial™) vs Mechanical Compression (TR Band®) Following Transradial Access: A pilot Study.,"BACKGROUND


Hemostasis following transradial arterial access (TRA) is usually achieved by mechanical compression. This study investigated if use of a chitosan-based hemostatic pad (Clo-Sur Plus  Radial™) combined with mechanical compression (TR Band®) could shorten hemostasis time after TRA, compared with a TR Band® alone.
METHODS


40 patients undergoing cardiac catheterization and/or percutaneous coronary intervention were assigned into 4 cohorts post TRA: 10 patients received mechanical compression with a TR Band® alone for 120 min. The other 30 patients received compression with a Clo-Sur Plus  Radial™ pad combined with a TR Band® for 60 min, 45 min, and 30 min, respectively (n = 10/per cohort). Times to hemostasis and access-site complications were recorded.
RESULTS


There were no differences in patient characteristics, mean dose of heparin, or mean activated clotting time value at the end of procedure among the four cohorts. Median time to hemostasis with the TR Band® alone was 120.5 min versus 60 min, 45 min and 30 min for the 60-min, 45-min, and 30-min Clo-Sur Plus  Radial™ pad combined with the TR Band® cohorts, respectively. No radial artery occlusion, late rebleeding nor hematoma was noted in this series of patients.
CONCLUSIONS


In this pilot trial, use of a Clo-Sur Plus  Radial™ pad in combination with a TR band® significantly shortened hemostasis time, as compared to a TR band® alone, with no increased complications noted.",2019,"Median time to hemostasis with the TR Band® alone was 120.5 min versus 60 min, 45 min and 30 min for the 60-min, 45-min, and 30-min Clo-Sur Plus  Radial™ pad combined with the TR Band® cohorts, respectively.",['40 patients undergoing'],"['compression with a Clo-Sur Plus  Radial™ pad combined with a TR Band®', 'cardiac catheterization and/or percutaneous coronary intervention', 'mechanical compression with a TR Band® alone for 120\u202fmin', 'chitosan-based hemostatic pad (Clo-Sur Plus  Radial™) vs mechanical compression (TR Band®', 'Clo-Sur Plus  Radial™ pad in combination with a TR band®', 'transradial arterial access (TRA', 'chitosan-based hemostatic pad (Clo-Sur Plus  Radial™) combined with mechanical compression (TR Band®']","['radial artery occlusion, late rebleeding nor hematoma', 'Times to hemostasis and access-site complications', 'patient characteristics, mean dose of heparin, or mean activated clotting time value', 'hemostasis time', 'Median time to hemostasis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0018795', 'cui_str': 'Catheterization, Heart'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0563291', 'cui_str': 'Mechanical compression (physical force)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0162969', 'cui_str': 'Chitosan'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0019120', 'cui_str': 'Hemostatics'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]","[{'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",40.0,0.148964,"Median time to hemostasis with the TR Band® alone was 120.5 min versus 60 min, 45 min and 30 min for the 60-min, 45-min, and 30-min Clo-Sur Plus  Radial™ pad combined with the TR Band® cohorts, respectively.","[{'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Roberts', 'Affiliation': 'Memorial Regional Hospital, Memorial Cardiac and Vascular Institute, Memorial Healthcare System, Hollywood, FL 33021, USA. Electronic address: jonathanroberts@mhs.net.'}, {'ForeName': 'Jianli', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': 'Memorial Regional Hospital, Memorial Cardiac and Vascular Institute, Memorial Healthcare System, Hollywood, FL 33021, USA.'}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Pastor-Cervantes', 'Affiliation': 'Memorial Regional Hospital, Memorial Cardiac and Vascular Institute, Memorial Healthcare System, Hollywood, FL 33021, USA.'}]",Cardiovascular revascularization medicine : including molecular interventions,['10.1016/j.carrev.2018.11.026']
354,30295319,A Family Focused Intervention Influences Hippocampal-Prefrontal Connectivity Through Gains in Self-Regulation.,"The stressors associated with poverty increase the risks for externalizing psychopathology; however, specific patterns of neurobiology and higher self-regulation may buffer against these effects. This study leveraged a randomized control trial, aimed at increasing self-regulation at ~11 years of age. As adults, these same individuals completed functional MRI scanning (M age   = 24.88 years; intervention n = 44; control n = 49). Functional connectivity between the hippocampus and ventromedial prefrontal cortex was examined in relation to the intervention, gains in self-regulation, and present-day externalizing symptoms. Increased connectivity between these brain areas was noted in the intervention group compared to controls. Furthermore, individual gains in self-regulation, instilled by the intervention, statistically explained this brain difference. These results begin to connect neurobiological and psychosocial markers of risk and resiliency.",2019,Increased connectivity between these brain areas was noted in the intervention group compared to controls.,"['As adults, these same individuals completed functional MRI scanning (M age  \xa0', '11\xa0years of age']",[],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],[],,0.0132259,Increased connectivity between these brain areas was noted in the intervention group compared to controls.,"[{'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Hanson', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Alysha D', 'Initials': 'AD', 'LastName': 'Gillmore', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Tianyi', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'University of Georgia.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Holmes', 'Affiliation': 'University of Georgia.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Hallowell', 'Affiliation': 'University of Georgia.'}, {'ForeName': 'Allen W', 'Initials': 'AW', 'LastName': 'Barton', 'Affiliation': 'University of Georgia.'}, {'ForeName': 'Steven R H', 'Initials': 'SRH', 'LastName': 'Beach', 'Affiliation': 'University of Georgia.'}, {'ForeName': 'Adrianna', 'Initials': 'A', 'LastName': 'Galván', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'MacKillop', 'Affiliation': 'McMaster University.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Windle', 'Affiliation': 'Emory University.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Chen', 'Affiliation': 'Northwestern University.'}, {'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Miller', 'Affiliation': 'Northwestern University.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Sweet', 'Affiliation': 'University of Georgia.'}, {'ForeName': 'Gene H', 'Initials': 'GH', 'LastName': 'Brody', 'Affiliation': 'University of Georgia.'}]",Child development,['10.1111/cdev.13154']
355,31227493,How do the costs of physical therapy and arthroscopic partial meniscectomy compare? A trial-based economic evaluation of two treatments in patients with meniscal tears alongside the ESCAPE study.,"OBJECTIVES


To examine whether physical therapy (PT) is cost-effective compared with arthroscopic partial meniscectomy (APM) in patients with a non-obstructive meniscal tear, we performed a full trial-based economic evaluation from a societal perspective. In a secondary analysis-this paper-we examined whether PT is non-inferior to APM.
METHODS


We recruited patients aged 45-70 years with a non-obstructive meniscal tear in nine Dutch hospitals. Resource use was measured using web-based questionnaires. Measures of effectiveness included knee function using the International Knee Documentation Committee (IKDC) and quality-adjusted life-years (QALYs). Follow-up was 24 months. Uncertainty was assessed using bootstrapping techniques. The non-inferiority margins for societal costs, the IKDC and QALYs, were €670, 8 points and 0.057 points, respectively.
RESULTS


We randomly assigned 321 patients to PT (n=162) or APM (n=159). PT was associated with significantly lower costs after 24 months compared with APM (-€1803; 95% CI -€3008 to -€838). The probability of PT being cost-effective compared with APM was 1.00 at a willingness to pay of €0/unit of effect for the IKDC (knee function) and QALYs (quality of life) and decreased with increasing values of willingness to pay. The probability that PT is non-inferior to APM was 0.97 for all non-inferiority margins for the IKDC and 0.89 for QALYs.
CONCLUSIONS


The probability of PT being cost-effective compared with APM was relatively high at reasonable values of willingness to pay for the IKDC and QALYs. Also, PT had a relatively high probability of being non-inferior to APM for both outcomes. This warrants further deimplementation of APM in patients with non-obstructive meniscal tears.
TRIAL REGISTRATION NUMBERS


NCT01850719 and NTR3908.",2020,PT was associated with significantly lower costs after 24 months compared with APM (-€1803; 95% CI -€3008 to -€838).,"['patients with a non-obstructive meniscal tear', '321 patients to PT (n=162) or APM (n=159', 'patients with non-obstructive meniscal tears', 'patients with meniscal tears alongside the ESCAPE study', 'patients aged 45-70 years with a non-obstructive meniscal tear in nine Dutch hospitals']","['physical therapy (PT', 'arthroscopic partial meniscectomy (APM']","['probability of PT being cost-effective', 'International Knee Documentation Committee (IKDC) and quality-adjusted life-years (QALYs', 'IKDC (knee function) and QALYs (quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205304', 'cui_str': 'Non-obstructive (qualifier value)'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0187901', 'cui_str': 'Meniscal Resection'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}]",321.0,0.0651893,PT was associated with significantly lower costs after 24 months compared with APM (-€1803; 95% CI -€3008 to -€838).,"[{'ForeName': 'Victor A', 'Initials': 'VA', 'LastName': 'van de Graaf', 'Affiliation': 'Department of Orthopaedic Surgery, Joint Research, OLVG, Amsterdam, The Netherlands v.a.vandegraaf@olvg.nl.'}, {'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'van Dongen', 'Affiliation': 'Department of Health Sciences, VU University, Amsterdam, The Netherlands.'}, {'ForeName': 'Nienke W', 'Initials': 'NW', 'LastName': 'Willigenburg', 'Affiliation': 'Department of Orthopaedic Surgery, Joint Research, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Julia C A', 'Initials': 'JCA', 'LastName': 'Noorduyn', 'Affiliation': 'Department of Orthopaedic Surgery, Joint Research, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Ise K', 'Initials': 'IK', 'LastName': 'Butter', 'Affiliation': 'Department of Orthopaedic Surgery, Joint Research, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'de Gast', 'Affiliation': 'Department of Orthopaedic Surgery, Clinical Orthopaedic Research Centre - mN, Diakonessenhuis, Utrecht, The Netherlands.'}, {'ForeName': 'Daniel B F', 'Initials': 'DBF', 'LastName': 'Saris', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Maurits W', 'Initials': 'MW', 'LastName': 'van Tulder', 'Affiliation': 'Department of Health Sciences, VU University, Amsterdam, The Netherlands.'}, {'ForeName': 'Rudolf W', 'Initials': 'RW', 'LastName': 'Poolman', 'Affiliation': 'Department of Orthopaedic Surgery, Joint Research, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of sports medicine,['10.1136/bjsports-2018-100065']
356,31562118,Visual benefit versus visual gain: what is the effect of baseline covariants in the treatment arm relative to the control arm? A pooled analysis of ANCHOR and MARINA.,"BACKGROUND


This study aimed to elucidate visual benefits of ranibizumab in patients with neovascular age-related macular degeneration (nAMD) compared with control arms and identify factors affecting response.
METHODS


This is a post-hoc pooled analysis of two phase III studies, ANCHOR and MARINA, of ranibizumab for the treatment of nAMD. ANCHOR included 83 international sites. MARINA included 96 sites in the USA. Analysis included patients (control, n=323; ranibizumab, n=332) with nAMD and a baseline best-corrected visual acuity (BCVA) of ≥35-<85 letters.
RESULTS


Patients receiving ranibizumab achieved an adjusted mean BCVA superiority of 18.9 and 21.2 letters over 12 and 24 months, respectively, compared with control. Ranibizumab treatment, higher baseline BCVA, lower age and smaller lesion size were positively associated with the ability to achieve BCVA >69 letters. Patients with the highest baseline BCVA had lowest BCVA gains. Ranibizumab treatment, lower baseline BCVA, lower age and smaller lesion size were identified as significant predictors of BCVA gain from baseline at month 24 (all p<0.0001). However, the difference in mean BCVA gains at month 24 between treatment and control groups was similar for all baseline BCVA subgroups (≥35-<55 letters, 21.9 letters; ≥55-<70 letters, 25.2 letters; ≥70-<85 letters, 19.3 letters).
CONCLUSIONS


Higher baseline BCVA is associated with lower BCVA gains but a greater likelihood of achieving good final BCVA >69 letters due to smaller gains needed to achieve response. Visual benefits, including maintenance of visual acuity (VA), final VA achieved and relative gain compared with natural disease progression, should be considered when assessing treatment response in nAMD.",2020,"Ranibizumab treatment, lower baseline BCVA, lower age and smaller lesion size were identified as significant predictors of BCVA gain from baseline at month 24 (all p<0.0001).","['patients with neovascular age-related macular degeneration (nAMD', 'Analysis included patients (control, n=323; ranibizumab, n=332) with nAMD and a baseline best-corrected visual acuity (BCVA) of ≥35-<85 letters']","['ranibizumab', 'Ranibizumab', 'Visual benefit versus visual gain']","['BCVA gains', 'lower baseline BCVA, lower age and smaller lesion size', 'higher baseline BCVA, lower age and smaller lesion size', 'mean BCVA superiority', 'Visual benefits, including maintenance of visual acuity (VA', 'BCVA gain', 'lowest BCVA gains', 'mean BCVA gains']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}]",69.0,0.150313,"Ranibizumab treatment, lower baseline BCVA, lower age and smaller lesion size were identified as significant predictors of BCVA gain from baseline at month 24 (all p<0.0001).","[{'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Tufail', 'Affiliation': 'Medical Retina, Moorfields Eye Hospital & Institute of Ophthalmology UCL, London, UK adnan.tufail@moorfields.nhs.uk.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Margaron', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Tadhg', 'Initials': 'T', 'LastName': 'Guerin', 'Affiliation': 'Theravance Biopharma, Dublin, Ireland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Larsen', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet & Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2018-313682']
357,31231780,Immunogenicity noninferiority study of 2 doses and 3 doses of an Escherichia coli-produced HPV bivalent vaccine in girls vs. 3 doses in young women.,"A new HPV-16/18 bivalent vaccine expressed by the Escherichia coli has been proven to be efficacious in adult women. A randomized, immunogenicity noninferiority study of this candidate vaccine was conducted in December 2015 in China. Girls aged 9-14 years were randomized to receive 2 doses at months 0 and 6 (n=301) or 3 doses at months 0, 1 and 6 (n=304). Girls aged 15-17 years (n=149) and women aged 18-26 years (n=225) received 3 doses. The objectives included noninferiority analysis of the IgG geometric mean concentration (GMC) ratio (95% CI, lower bound>0.5) to HPV-16 and HPV-18 at month 7 in girls compared with women. In the per-protocol set, the GMC ratio of IgG was noninferior for girls aged 9-17 years receiving 3 doses compared with women (1.76 (95% CI, 1.56, 1.99) for HPV-16 and 1.93 (95% CI, 1.69, 2.21) for HPV-18) and noninferior for girls aged 9-14 years receiving 2 doses compared with women (1.45 (95% CI, 1.25, 1.62) for HPV-16 and 1.17 (95% CI, 1.02, 1.33) for HPV-18). Noninferiority was also demonstrated for neutralizing antibodies. The immunogenicity of the HPV vaccine in girls receiving 3 or 2 doses was noninferior compared with that in young adult women.",2020,The immunogenicity of the HPV vaccine in girls receiving 3 or 2 doses was noninferior compared with that in young adult women.,"['Girls aged 15-17 years (n=149) and women aged 18-26 years (n=225) received 3 doses', 'girls receiving 3 or 2 doses was noninferior compared with that in young adult women', 'girls vs. 3 doses in young women', 'Girls aged 9-14 years', 'December 2015 in China', 'adult women']","['Escherichia coli-produced HPV bivalent vaccine', 'HPV vaccine']","['IgG geometric mean concentration (GMC) ratio', 'GMC ratio of IgG', 'neutralizing antibodies']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}]","[{'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}]",,0.320641,The immunogenicity of the HPV vaccine in girls receiving 3 or 2 doses was noninferior compared with that in young adult women.,"[{'ForeName': 'Yue-Mei', 'Initials': 'YM', 'LastName': 'Hu', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, 210009, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'Chang-Gui', 'Initials': 'CG', 'LastName': 'Li', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, 102629, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Chu', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, 210009, China.'}, {'ForeName': 'Wen-Gang', 'Initials': 'WG', 'LastName': 'He', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Sheyang Center for Disease Control and Prevention, Sheyang, 244300, China.'}, {'ForeName': 'Jian-Xiang', 'Initials': 'JX', 'LastName': 'Gu', 'Affiliation': 'Sheyang Center for Disease Control and Prevention, Sheyang, 244300, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, 102629, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, 102629, China.'}, {'ForeName': 'Xiang-Hong', 'Initials': 'XH', 'LastName': 'Wu', 'Affiliation': 'Sheyang Center for Disease Control and Prevention, Sheyang, 244300, China.'}, {'ForeName': 'BiZhen', 'Initials': 'B', 'LastName': 'Lin', 'Affiliation': 'Xiamen Innovax Biotech Company, Xiamen, 361022, China.'}, {'ForeName': 'Zhi-Jie', 'Initials': 'ZJ', 'LastName': 'Lin', 'Affiliation': 'Xiamen Innovax Biotech Company, Xiamen, 361022, China.'}, {'ForeName': 'Xing-Mei', 'Initials': 'XM', 'LastName': 'Yao', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'Ya-Fei', 'Initials': 'YF', 'LastName': 'Li', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'FeiXue', 'Initials': 'F', 'LastName': 'Wei', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'Ying-Ying', 'Initials': 'YY', 'LastName': 'Su', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'Feng-Cai', 'Initials': 'FC', 'LastName': 'Zhu', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, 210009, China.'}, {'ForeName': 'Shou-Jie', 'Initials': 'SJ', 'LastName': 'Huang', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'Hui-Rong', 'Initials': 'HR', 'LastName': 'Pan', 'Affiliation': 'Xiamen Innovax Biotech Company, Xiamen, 361022, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China. zhangj@xmu.edu.cn.'}, {'ForeName': 'Ning-Shao', 'Initials': 'NS', 'LastName': 'Xia', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China. nsxia@xmu.edu.cn.'}]",Science China. Life sciences,['10.1007/s11427-019-9547-7']
358,31836635,Cost-effectiveness of strategies preventing late-onset infection in preterm infants.,"OBJECTIVE


Developing a model to analyse the cost-effectiveness of interventions preventing late-onset infection (LOI) in preterm infants and applying it to the evaluation of anti-microbial impregnated peripherally inserted central catheters (AM-PICCs) compared with standard PICCs (S-PICCs).
DESIGN


Model-based cost-effectiveness analysis, using data from the Preventing infection using Antimicrobial Impregnated Long Lines (PREVAIL) randomised controlled trial linked to routine healthcare data, supplemented with published literature. The model assumes that LOI increases the risk of neurodevelopmental impairment (NDI).
SETTING


Neonatal intensive care units in the UK National Health Service (NHS).
PATIENTS


Infants born ≤32 weeks gestational age, requiring a 1 French gauge PICC.
INTERVENTIONS


AM-PICC and S-PICC.
MAIN OUTCOME MEASURES


Life expectancy, quality-adjusted life years (QALYs) and healthcare costs over the infants' expected lifetime.
RESULTS


Severe NDI reduces life expectancy by 14.79 (95% CI 4.43 to 26.68; undiscounted) years, 10.63 (95% CI 7.74 to 14.02; discounted) QALYs and costs £19 057 (95% CI £14 197; £24697; discounted) to the NHS. If LOI causes NDI, the maximum acquisition price of an intervention reducing LOI risk by 5% is £120. AM-PICCs increase costs (£54.85 (95% CI £25.95 to £89.12)) but have negligible impact on health outcomes (-0.01 (95% CI -0.09 to 0.04) QALYs), compared with S-PICCs. The NHS can invest up to £2.4 million in research to confirm that AM-PICCs are not cost-effective.
CONCLUSIONS


The model quantifies health losses and additional healthcare costs caused by NDI and LOI during neonatal care. Given these consequences, interventions preventing LOI, even by a small extent, can be cost-effective. AM-PICCs, being less effective and more costly than S-PICC, are not likely to be cost-effective.
TRIAL REGISTRATION NUMBER


NCT03260517.",2020,"Severe NDI reduces life expectancy by 14.79 (95% CI 4.43 to 26.68; undiscounted) years, 10.63","['Infants born ≤32 weeks gestational age, requiring a 1 French gauge PICC', 'preterm infants', 'Neonatal intensive care units in the UK National Health Service (NHS']",['standard PICCs (S-PICCs'],"['health outcomes', 'AM-PICCs increase costs', 'LOI risk', 'risk of neurodevelopmental impairment (NDI', ""Life expectancy, quality-adjusted life years (QALYs) and healthcare costs over the infants' expected lifetime"", 'Severe NDI reduces life expectancy']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0580793', 'cui_str': 'French gauge'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C1563705', 'cui_str': 'Diabetes Insipidus, Nephrogenic, Type I'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",,0.142018,"Severe NDI reduces life expectancy by 14.79 (95% CI 4.43 to 26.68; undiscounted) years, 10.63","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Grosso', 'Affiliation': 'Centre for Health Economics, University of York, York, UK alessandro.grosso@york.ac.uk.'}, {'ForeName': 'Rita Isabel', 'Initials': 'RI', 'LastName': 'Neves de Faria', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bojke', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Donohue', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, Liverpool, Merseyside, UK.'}, {'ForeName': 'Caroline Isabel', 'Initials': 'CI', 'LastName': 'Fraser', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, London, United Kingdom.'}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Harron', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, London, United Kingdom.'}, {'ForeName': 'Sam J', 'Initials': 'SJ', 'LastName': 'Oddie', 'Affiliation': 'Bradford Neonatology, Bradford Royal Infirmary, West Yorkshire, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Gilbert', 'Affiliation': 'MRC Centre of Epidemiology for Child Health, UCL Institute of Child Health, London, United Kingdom.'}]",Archives of disease in childhood,['10.1136/archdischild-2019-317640']
359,31738834,Randomized multicenter trial of sirolimus vs prednisone as initial therapy for standard-risk acute GVHD: the BMT CTN 1501 trial.,"Clinical- and biomarker-based tools may identify a lower-risk acute graft-versus-host disease (GVHD) population amenable to novel, reduced-intensity treatments. Previous data suggest sirolimus may rival standard of care prednisone. We conducted a National Heart, Lung, and Blood Institute/National Cancer Institute-funded Blood and Marrow Transplant Clinical Trials Network multicenter, open-label, randomized phase 2 trial to estimate the difference in day 28 complete response (CR)/partial response (PR) rates for sirolimus vs prednisone as initial treatment of patients with standard risk (SR) acute GVHD as defined by the Minnesota (MN) GVHD Risk Score and Ann Arbor (AA1/2) biomarker status. A total of 127 MN-SR patients were randomized (1:1), and 122 were AA1/2 (sirolimus, n = 58; prednisone, n = 64). Others were AA3 (n = 4), or AA status missing (n = 1). The day 28 CR/PR rates were similar for sirolimus 64.8% (90% confidence interval [CI], 54.1%-75.5%) vs 73% (90% CI, 63.8%-82.2%) for prednisone. The day 28 rate of CR/PR with prednisone ≤0.25 mg/kg/day was significantly higher for sirolimus than prednisone (66.7% vs 31.7%; P < .001). No differences were detected in steroid-refractory acute GVHD, disease-free survival, relapse, nonrelapse mortality, or overall survival. Sirolimus was associated with reduced steroid exposure and hyperglycemia, reduced grade 2 to 3 infections, improvement in immune suppression discontinuation and patient-reported quality of life, and increased risk for thrombotic microangiopathy. For patients with clinical- and biomarker-based SR acute GVHD, sirolimus demonstrates similar overall initial treatment efficacy as prednisone. In addition, sirolimus therapy spares steroid exposure and allied toxicity, does not compromise long-term survival outcomes, and is associated with improved patient-reported quality of life. This trial was registered at www.clinicaltrials.gov as #NCT02806947.",2020,"No differences were detected in steroid-refractory acute GVHD, disease-free survival, relapse, non-relapse mortality, or overall survival.","['patients with standard risk (SR) acute GVHD', 'Standard Risk Acute GVHD', 'A total of 127 MN-SR patients were randomized (1:1), and 122 were AA1/2 ']","['sirolimus vs. prednisone', 'Sirolimus', 'Sirolimus vs. Prednisone', 'sirolimus', 'prednisone']","['complete response (CR)/partial response (PR) rates', 'steroid-refractory acute GVHD, disease-free survival, relapse, non-relapse mortality, or overall survival', 'reduced steroid exposure and hyperglycemia, reduced grade 2-3 infections, improvement in immune suppression discontinuation and patient-reported quality of life, and increased risk for thrombotic microangiopathy', 'PR rates', 'steroid exposure and allied toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0034380'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2717961', 'cui_str': 'Thrombotic Microangiopathies'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",127.0,0.125604,"No differences were detected in steroid-refractory acute GVHD, disease-free survival, relapse, non-relapse mortality, or overall survival.","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Pidala', 'Affiliation': 'Blood and Marrow Transplantation and Cellular Immunotherapy, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hamadani', 'Affiliation': 'BMT and Cellular Therapy Program, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dawson', 'Affiliation': 'Emmes Corporation, Rockville, MD.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Martens', 'Affiliation': 'Emmes Corporation, Rockville, MD.'}, {'ForeName': 'Amin M', 'Initials': 'AM', 'LastName': 'Alousi', 'Affiliation': 'Department of Stem Cell Transplant and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Madan', 'Initials': 'M', 'LastName': 'Jagasia', 'Affiliation': 'Division of Hematology/Oncology, Stem Cell Transplantation, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Yvonne A', 'Initials': 'YA', 'LastName': 'Efebera', 'Affiliation': 'Blood and Marrow Transplantation Program, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Chhabra', 'Affiliation': 'BMT and Cellular Therapy Program, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Iskra', 'Initials': 'I', 'LastName': 'Pusic', 'Affiliation': 'Medical Oncology, Washington University School of Medicine in St. Louis, St. Louis, MO.'}, {'ForeName': 'Shernan G', 'Initials': 'SG', 'LastName': 'Holtan', 'Affiliation': 'Blood and Marrow Transplant Program, Departments of Pediatrics and Medicine, University of Minnesota Medical School, Minneapolis, MN.'}, {'ForeName': 'James L M', 'Initials': 'JLM', 'LastName': 'Ferrara', 'Affiliation': 'Blood and Marrow Transplantation Program, The Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Levine', 'Affiliation': 'Blood and Marrow Transplantation Program, The Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Mielcarek', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Anasetti', 'Affiliation': 'Blood and Marrow Transplantation and Cellular Immunotherapy, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'Joseph H', 'Initials': 'JH', 'LastName': 'Antin', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Bolaños-Meade', 'Affiliation': 'Department of Oncology, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; and.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Howard', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Brent R', 'Initials': 'BR', 'LastName': 'Logan', 'Affiliation': 'BMT and Cellular Therapy Program, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Leifer', 'Affiliation': 'Office of Biostatistics Research, National Heart, Lung, and Blood Institute, Bethesda, MD.'}, {'ForeName': 'Theresa S', 'Initials': 'TS', 'LastName': 'Pritchard', 'Affiliation': 'Emmes Corporation, Rockville, MD.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Horowitz', 'Affiliation': 'BMT and Cellular Therapy Program, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'MacMillan', 'Affiliation': 'Blood and Marrow Transplant Program, Departments of Pediatrics and Medicine, University of Minnesota Medical School, Minneapolis, MN.'}]",Blood,['10.1182/blood.2019003125']
360,31914878,Development of Predictive Equations for Nocturnal Hypertension and Nondipping Systolic Blood Pressure.,"Background Nocturnal hypertension, defined by a mean asleep systolic blood pressure (SBP)/diastolic blood pressure (BP) ≥120/70 mm Hg, and nondipping SBP, defined by an awake-to-asleep decline in SBP <10%, are each associated with increased risk for cardiovascular disease. Methods and Results We developed predictive equations to identify adults with a high probability of having nocturnal hypertension or nondipping SBP using data from the CARDIA (Coronary Artery Risk Development in Young Adults) study (n=787), JHS (Jackson Heart Study) (n=1063), IDH (Improving the Detection of Hypertension) study (n=395), and MHT (Masked Hypertension) study (n=772) who underwent 24-hour ambulatory BP monitoring. Participants were randomized to derivation (n=2511) or validation (n=506) data sets. The prevalence rates of nocturnal hypertension and nondipping SBP were 39.7% and 44.9% in the derivation data set, respectively, and 36.6% and 44.5% in the validation data set, respectively. The predictive equation for nocturnal hypertension included age, race/ethnicity, smoking status, neck circumference, height, high-density lipoprotein cholesterol, albumin/creatinine ratio, and clinic SBP and diastolic BP. The predictive equation for nondipping SBP included age, sex, race/ethnicity, waist circumference, height, alcohol use, high-density lipoprotein cholesterol, and albumin/creatinine ratio. Concordance statistics (95% CI) for nocturnal hypertension and nondipping SBP predictive equations in the validation data set were 0.84 (0.80-0.87) and 0.73 (0.69-0.78), respectively. Compared with reference models including antihypertensive medication use and clinic SBP and diastolic BP as predictors, the continuous net reclassification improvement (95% CI) values for the nocturnal hypertension and nondipping SBP predictive equations were 0.52 (0.35-0.69) and 0.51 (0.34-0.69), respectively. Conclusions These predictive equations can direct ambulatory BP monitoring toward adults with high probability of having nocturnal hypertension and nondipping SBP.",2020,"Concordance statistics (95% CI) for nocturnal hypertension and nondipping SBP predictive equations in the validation data set were 0.84 (0.80-0.87) and 0.73 (0.69-0.78), respectively.","['adults with high probability of having nocturnal hypertension and nondipping SBP', 'adults with a high probability of having nocturnal hypertension or nondipping SBP using data from the CARDIA (Coronary Artery Risk Development in Young Adults) study (n=787']",['24-hour ambulatory BP monitoring'],"['antihypertensive medication use and clinic SBP and diastolic BP', ' Nocturnal hypertension', 'mean asleep systolic blood pressure (SBP)/diastolic blood pressure (BP) ≥120/70\xa0mm\xa0Hg, and nondipping SBP', 'Nocturnal Hypertension and Nondipping Systolic Blood Pressure', 'density lipoprotein cholesterol, albumin/creatinine ratio, and clinic SBP and diastolic BP', 'Concordance statistics', 'nocturnal hypertension and nondipping SBP predictive equations', 'prevalence rates of nocturnal hypertension and nondipping SBP']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0007144', 'cui_str': 'Cardia'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}]","[{'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",,0.0416412,"Concordance statistics (95% CI) for nocturnal hypertension and nondipping SBP predictive equations in the validation data set were 0.84 (0.80-0.87) and 0.73 (0.69-0.78), respectively.","[{'ForeName': 'Byron C', 'Initials': 'BC', 'LastName': 'Jaeger', 'Affiliation': 'Department of Biostatistics University of Alabama at Birmingham AL.'}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Booth', 'Affiliation': 'Department of Epidemiology University of Alabama at Birmingham AL.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Butler', 'Affiliation': 'Department of Population Health Sciences New York University School of Medicine New York NY.'}, {'ForeName': 'Lloyd J', 'Initials': 'LJ', 'LastName': 'Edwards', 'Affiliation': 'Department of Biostatistics University of Alabama at Birmingham AL.'}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Department of Epidemiology University of Alabama at Birmingham AL.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Lloyd-Jones', 'Affiliation': 'Department of Preventive Medicine Northwestern University Evanston IL.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Sakhuja', 'Affiliation': 'Department of Epidemiology University of Alabama at Birmingham AL.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Schwartz', 'Affiliation': 'Department of Psychiatry Stony Brook School of Medicine Stony Brook NY.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Shikany', 'Affiliation': 'Division of Preventive Medicine Department of Medicine University of Alabama at Birmingham AL.'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Shimbo', 'Affiliation': 'Department of Medicine Columbia University Medical Center New York NY.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Yano', 'Affiliation': 'Department of Community and Family Medicine Duke University Durham NC.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Muntner', 'Affiliation': 'Department of Epidemiology University of Alabama at Birmingham AL.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.013696']
361,32208178,Utilizing Community Engagement Studios to inform patient experience in a multicenter randomized control trial.,"OBJECTIVE


To determine whether a community engagement approach can provide feedback for implementation of valuable measures to improve the outcome of a clinical trial.
METHODS


Review of the results from a Community Engagement Studio (CE Studio) for the ValEAR trial: an NIH-funded, multi-institutional study designed to research the efficacy of valganciclovir in the treatment of congenital cytomegalovirus (cCMV)-induced hearing loss. Participants were given information about the trial then asked a series of questions to assess their input on the merits or weaknesses affecting their participation in the trial.
RESULTS


Thirteen parents whose children have congenital CMV infection were recruited for the CE Studio. The overall theme from the responses was a desire to advance the field but a need to clearly understand the risks and benefits of participation. Many requested more educational resources, more printed materials, or greater access to researchers if questions arose. Many welcomed having patient stories and information displayed in a dedicated website or through social media.
CONCLUSION


This community engagement approach provided useful feedback from families similar to those expected to be potential enrollees in the CMV ValEAR trial. In response to parental comments, two educational videos were created: one on the general topic of cCMV and the other specific to the CMV ValEAR trial. Researchers who wish to optimize their clinical trial's success should consider incorporating a CE Studio into their study design.",2020,This community engagement approach provided useful feedback from families similar to those expected to be potential enrollees in the CMV ValEAR trial.,"['congenital cytomegalovirus (cCMV)-induced hearing loss', 'Thirteen parents whose children have congenital CMV infection were recruited for the CE Studio']","['Community Engagement Studio (CE Studio', 'valganciclovir']",[],"[{'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0010825', 'cui_str': 'Salivary Gland Viruses'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0158945', 'cui_str': 'Congenital cytomegalovirus infection (disorder)'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0909381', 'cui_str': 'valganciclovir'}]",[],13.0,0.130066,This community engagement approach provided useful feedback from families similar to those expected to be potential enrollees in the CMV ValEAR trial.,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Nielson', 'Affiliation': 'Division of Otolaryngology - Head and Neck Surgery, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Yiqing', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Division of Otolaryngology - Head and Neck Surgery, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'C Amanda', 'Initials': 'CA', 'LastName': 'Kull', 'Affiliation': 'Division of Otolaryngology - Head and Neck Surgery, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Albert H', 'Initials': 'AH', 'LastName': 'Park', 'Affiliation': 'Division of Otolaryngology - Head and Neck Surgery, University of Utah School of Medicine, Salt Lake City, UT, USA. Electronic address: Albert.Park@hsc.utah.edu.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110007']
362,32305492,Probiotics and fructo-oligosaccharide intervention modulate the microbiota-gut brain axis to improve autism spectrum reducing also the hyper-serotonergic state and the dopamine metabolism disorder.,"The prevalence of autism spectrum disorders (ASD) is increasing, but its etiology remains elusive and hence an effective treatment is not available. Previous research conducted on animal models suggests that microbiota-gut-brain axis may contribute to ASD pathology and more human research is needed. This study was divided into two stages,.At the discovery stage, we compared the differences in gut microbiota profiles (using 16S rRNA sequencing), fecal SCFAs (using GC-MS) and plasma neurotransmitters (using UHPLC-MS/MS) of 26 children with ASD and 24 normal children. All 26 children with ASD participated in the intervention stage, and we measured the gut microbiota profiles, SCFAs and neurotransmitters before and after probiotics + FOS (n = 16) or placebo supplementation (n = 10). We found that gut microbiota was in a state of dysbiosis and significantly lower levels of Bifidobacteriales and Bifidobacterium longum were observed at the discovery stage in children with ASD. An increase in beneficial bacteria (Bifidobacteriales and B. longum) and suppression of suspected pathogenic bacteria (Clostridium) emerged after probiotics + FOS intervention, with significant reduction in the severity of autism and gastrointestinal symptoms. Compared to children in the control group, significantly lower levels of acetic acid, propionic acid and butyric acid were found, and a hyperserotonergic state (increased serotonin) and dopamine metabolism disorder (decreased homovanillic acid) were observed in children with ASD. Interestingly, the above SCFAs in children with autism significantly elevated after probiotics + FOS intervention and approached those in the control group. In addition, our data demonstrated that decreased serotonin and increased homovanillic acid emerged after probiotics + FOS intervention. However, the above-mentioned changes did not appear in the placebo group for ASD children. Probiotics + FOS intervention can modulate gut microbiota, SCFAs and serotonin in association with improved ASD symptoms, including a hyper-serotonergic state and dopamine metabolism disorder.",2020,"Compared to children in the control group, significantly lower levels of acetic acid, propionic acid and butyric acid were found, and a hyperserotonergic state (increased serotonin) and dopamine metabolism disorder (decreased homovanillic acid) were observed in children with ASD.","['26 children with ASD', '26 children with ASD and 24 normal children', 'autism', 'autism spectrum disorders (ASD', 'children with ASD']","['Probiotics and fructo-oligosaccharide intervention', 'placebo supplementation', 'Probiotics\u2009+\u2009FOS intervention', 'placebo']","['gut microbiota profiles (using 16S rRNA sequencing), fecal SCFAs (using GC-MS) and plasma neurotransmitters', 'hyperserotonergic state (increased serotonin) and dopamine metabolism disorder (decreased homovanillic acid', 'severity of autism and gastrointestinal symptoms', 'acetic acid, propionic acid and butyric acid', 'homovanillic acid', 'beneficial bacteria (Bifidobacteriales and B. longum) and suppression of suspected pathogenic bacteria (Clostridium']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0873033', 'cui_str': 'fructooligosaccharide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0087140', 'cui_str': 'v-fos Oncogenes'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0024868', 'cui_str': 'Chromatography, Gas-Mass Spectrometry'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0027908', 'cui_str': 'Neurotransmitter'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0025517', 'cui_str': 'Metabolic disease'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0019903', 'cui_str': 'Homovanillic acid'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0033482', 'cui_str': 'Propanoic Acids'}, {'cui': 'C0006523', 'cui_str': 'Butanoic Acids'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C1037103', 'cui_str': 'Bifidobacteriales'}, {'cui': 'C1564227', 'cui_str': 'Longum'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0009054', 'cui_str': 'Clostridium'}]",26.0,0.0229384,"Compared to children in the control group, significantly lower levels of acetic acid, propionic acid and butyric acid were found, and a hyperserotonergic state (increased serotonin) and dopamine metabolism disorder (decreased homovanillic acid) were observed in children with ASD.","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China; State Key Laboratory of Microbial Technology, Shandong University, Qingdao, Shandong, China. Electronic address: wangyingying67@163.com.""}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': ""Institute of Child Health Care, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: 754520623@qq.com.""}, {'ForeName': 'Jun-Jie', 'Initials': 'JJ', 'LastName': 'Yang', 'Affiliation': 'College of Life Science, Qilu Normal University, Jinan, Shandong, China. Electronic address: microbiota@foxmail.com.'}, {'ForeName': 'Dong-Mei', 'Initials': 'DM', 'LastName': 'Zhao', 'Affiliation': ""Institute of Child Health Care, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: jnzhaodongmei@163.com.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': ""Beijing Advanced Innovation Center for Big Data-Based Precision Medicine, School of Medicine and Engineering, Beihang University, Key Laboratory of Big Data-Based Precision Medicine (Beihang University), the Ministry of Industry and Information Technology of the People's Republic of China, Beijing, China. Electronic address: binchen23@163.com.""}, {'ForeName': 'Guo-Qing', 'Initials': 'GQ', 'LastName': 'Zhang', 'Affiliation': 'Bio-Med Big Data Center, CAS Key Laboratory of Computational Biology, CAS-MPG Partner Institute for Computational Biology, Shanghai Institute of Nutrition and Health, Shanghai, China. Electronic address: gqzhang@picb.ac.cn.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Shenzhen Institute of Synthetic Biology, Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences, Shenzhen, Guangdong, China; CAS Key Laboratory of Quantitative Engineering Biology, Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences, Shenzhen, Guangdong, China. Electronic address: shuo.chen1@siat.ac.cn.'}, {'ForeName': 'Rui-Fang', 'Initials': 'RF', 'LastName': 'Cao', 'Affiliation': 'Bio-Med Big Data Center, CAS Key Laboratory of Computational Biology, CAS-MPG Partner Institute for Computational Biology, Shanghai Institute of Nutrition and Health, Shanghai, China. Electronic address: caoruifang@picb.ac.cn.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: yuhan_1991@163.com.""}, {'ForeName': 'Chang-Ying', 'Initials': 'CY', 'LastName': 'Zhao', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: 1163310981@qq.com.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: 1295163749@qq.com.""}, {'ForeName': 'Yong-Sheng', 'Initials': 'YS', 'LastName': 'Ge', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: 1305358934@qq.com.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: liuyi-ly@126.com.""}, {'ForeName': 'Le-Hai', 'Initials': 'LH', 'LastName': 'Zhang', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: zlh6813@126.com.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'State Key Laboratory of Microbial Technology, Shandong University, Qingdao, Shandong, China. Electronic address: hw_1@sdu.edu.cn.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Beijing Advanced Innovation Center for Big Data-Based Precision Medicine, School of Medicine and Engineering, Beihang University, Key Laboratory of Big Data-Based Precision Medicine (Beihang University), the Ministry of Industry and Information Technology of the People's Republic of China, Beijing, China; Microbiome Research Center, Shandong Institutes for Food and Drug Control, Shandong Institute of Industrial Technology for Health Sciences and Precision Medicine, Jinan, Shandong, China. Electronic address: microbiome@foxmail.com.""}, {'ForeName': 'Zhong-Tao', 'Initials': 'ZT', 'LastName': 'Gai', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: gzt@etyy.com.""}]",Pharmacological research,['10.1016/j.phrs.2020.104784']
363,31112621,"Pharmacokinetics and safety of tobramycin nebulization with the I-neb and PARI-LC Plus in children with cystic fibrosis: A randomized, crossover study.","AIMS


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


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


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


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


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


Inhalations were well tolerated and serum trough concentrations below the predefined toxic limit were reached with no significant differences in PK parameters between nebulizers.","[{'ForeName': 'Annelies J', 'Initials': 'AJ', 'LastName': 'van Velzen', 'Affiliation': 'Central Hospital Pharmacy, The Hague, The Netherlands.'}, {'ForeName': 'Joris W F', 'Initials': 'JWF', 'LastName': 'Uges', 'Affiliation': 'Central Hospital Pharmacy, The Hague, The Netherlands.'}, {'ForeName': 'Harry G M', 'Initials': 'HGM', 'LastName': 'Heijerman', 'Affiliation': 'Department of Pulmonology, Haga Teaching Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Bert G M', 'Initials': 'BGM', 'LastName': 'Arets', 'Affiliation': ""Department of Pediatric Pulmonology, University Medical Center Utrecht-Wilhelmina Children's hospital, Utrecht, The Netherlands.""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Nuijsink', 'Affiliation': ""Department of Pediatric Pulmonology, Haga Teaching Hospital-Juliana Children's hospital, The Hague, The Netherlands.""}, {'ForeName': 'Els C', 'Initials': 'EC', 'LastName': 'van der Wiel-Kooij', 'Affiliation': ""Department of Pediatrics, div Respiratory Medicine and Allergology, Erasmus MC-Sophia Children's Hospital, University Medical Center, Rotterdam, The Netherlands.""}, {'ForeName': 'Erik M', 'Initials': 'EM', 'LastName': 'van Maarseveen', 'Affiliation': 'Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Gijsbert A', 'Initials': 'GA', 'LastName': 'van Zanten', 'Affiliation': 'Department of Otorhinolaryngology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Pullens', 'Affiliation': ""Department of Otorhinolaryngology, Erasmus MC-Sophia Children's Hospital, University Medical Center, Rotterdam, The Netherlands.""}, {'ForeName': 'Daan J', 'Initials': 'DJ', 'LastName': 'Touw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Hettie M', 'Initials': 'HM', 'LastName': 'Janssens', 'Affiliation': ""Department of Pediatrics, div Respiratory Medicine and Allergology, Erasmus MC-Sophia Children's Hospital, University Medical Center, Rotterdam, The Netherlands.""}]",British journal of clinical pharmacology,['10.1111/bcp.13988']
364,31795820,Does Animation Improve Comprehension of Risk Information in Patients with Low Health Literacy? A Randomized Trial.,"Introduction.  Enhanced visual effects, like animation, have the potential to improve comprehension of probabilistic risk information, particularly for those with lower health literacy. We tested the effect of presentation format on comprehension of colorectal cancer (CRC) screening probabilities to identify optimal risk communication strategies.  Methods.  Participants from a community foodbank and a cancer prevention center were randomized to 1 of 3 CRC screening risk presentations. The presentations used identical content but varied in format: 1) video with animated pictographs, 2) video with static pictographs, and 3) audiobooklet with static pictographs. Participants completed pre- and postpresentation surveys. The primary outcome was knowledge of probability/risk information regarding CRC screening, calculated as total, verbatim, and gist scores.  Results.  In total, 187 participants completed the study and were included in this analysis. Median age was 58 years (interquartile range [IQR]: 14 years), most participants were women (63%), and almost half had a high school education or less (46%). Approximately one-quarter had inadequate health literacy (Short Test of Functional Health Literacy in Adults marginal/inadequate: 28%; Brief Health Literacy Screener low: 18%), and about half had low numeracy (Subjective Numeracy Scale low: 54%; Graphical Literacy Measure low: 50%). We found no significant differences in total, verbatim, or gist knowledge across presentation formats (all  P  > 0.05).  Discussion.  Use of an animated pictograph to communicate risk does not appear to augment or impede knowledge of risk information. Regardless of health literacy level, difficulty understanding pictographs presenting numerical information persists. There may be a benefit to teaching or priming individuals on how to interpret numerical information presented in pictographs before communicating risk using visual methods.  Trial Registry:  NCT02151032.",2020,"Enhanced visual effects, like animation, have the potential to improve comprehension of probabilistic risk information, particularly for those with lower health literacy.","['187 participants completed the study and were included in this analysis', 'Patients with Low Health Literacy', 'Median age was 58 years (interquartile range [IQR]: 14 years), most participants were women (63%), and almost half had a high school education or less (46', 'Adults', 'Participants from a community foodbank and a cancer prevention center']","['video with animated pictographs, 2) video with static pictographs, and 3) audiobooklet with static pictographs']","['inadequate health literacy', 'total, verbatim, or gist knowledge across presentation formats', 'knowledge of probability/risk information regarding CRC screening, calculated as total, verbatim, and gist scores']","[{'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}]","[{'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal Stromal Tumors'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",187.0,0.0891652,"Enhanced visual effects, like animation, have the potential to improve comprehension of probabilistic risk information, particularly for those with lower health literacy.","[{'ForeName': 'Ashley J', 'Initials': 'AJ', 'LastName': 'Housten', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Geetanjali R', 'Initials': 'GR', 'LastName': 'Kamath', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Therese B', 'Initials': 'TB', 'LastName': 'Bevers', 'Affiliation': 'Department of Clinical Cancer Prevention, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Scott B', 'Initials': 'SB', 'LastName': 'Cantor', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Nickell', 'Initials': 'N', 'LastName': 'Dixon', 'Affiliation': 'Michigan Department of Health, Southern New Hampshire University, Lansing, MI, USA.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Hite', 'Affiliation': 'Department of Surgery, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Kallen', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Viola B', 'Initials': 'VB', 'LastName': 'Leal', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Volk', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X19890296']
365,31237173,Impact of Evidence-Based Stroke Care on Patient Outcomes: A Multilevel Analysis of an International Study.,"Background The uptake of proven stroke treatments varies widely. We aimed to determine the association of evidence-based processes of care for acute ischemic stroke ( AIS ) and clinical outcome of patients who participated in the HEADPOST (Head Positioning in Acute Stroke Trial), a multicenter cluster crossover trial of lying flat versus sitting up, head positioning in acute stroke. Methods and Results Use of 8 AIS processes of care were considered: reperfusion therapy in eligible patients; acute stroke unit care; antihypertensive, antiplatelet, statin, and anticoagulation for atrial fibrillation; dysphagia assessment; and physiotherapist review. Hierarchical, mixed, logistic regression models were performed to determine associations with good outcome (modified Rankin Scale scores 0-2) at 90 days, adjusted for patient and hospital variables. Among 9485 patients with AIS, implementation of all processes of care in eligible patients, or ""defect-free"" care, was associated with improved outcome (odds ratio, 1.40; 95% CI, 1.18-1.65) and better survival (odds ratio, 2.23; 95% CI , 1.62-3.09). Defect-free stroke care was also significantly associated with excellent outcome (modified Rankin Scale score 0-1) (odds ratio, 1.22; 95% CI , 1.04-1.43). No hospital characteristic was independently predictive of outcome. Only 1445 (15%) of eligible patients with AIS received all processes of care, with significant regional variations in overall and individual rates. Conclusions Use of evidence-based care is associated with improved clinical outcome in AIS . Strategies are required to address regional variation in the use of proven AIS treatments. Clinical Trial Registration URL : https://www.clinicaltrials.gov . Unique Identifier: NCT02162017.",2019,"Defect-free stroke care was also significantly associated with excellent outcome (modified Rankin Scale score 0-1) (odds ratio, 1.22; 95% CI , 1.04-1.43).","['patients who participated in the HEADPOST (Head Positioning in Acute Stroke Trial', 'Patient Outcomes', 'eligible patients; acute stroke unit care', '9485 patients with AIS']","['Evidence-Based Stroke Care', 'reperfusion therapy']","['better survival', 'Defect-free stroke care']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0582540', 'cui_str': 'Head positions'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",9485.0,0.163752,"Defect-free stroke care was also significantly associated with excellent outcome (modified Rankin Scale score 0-1) (odds ratio, 1.22; 95% CI , 1.04-1.43).","[{'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Muñoz Venturelli', 'Affiliation': '1 The George Institute for Global Health Faculty of Medicine University of New South Wales Sydney Australia.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': '1 The George Institute for Global Health Faculty of Medicine University of New South Wales Sydney Australia.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Middleton', 'Affiliation': '5 Nursing Research Institute St Vincents Health Australia (Sydney) and Australian Catholic University Sydney Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Watkins', 'Affiliation': '6 Faculty of Health and Wellbeing University of Central Lancashire Preston United Kingdom.'}, {'ForeName': 'Pablo M', 'Initials': 'PM', 'LastName': 'Lavados', 'Affiliation': '3 Servicio de Neurología Departamento de Neurología y Psiquiatría Alemana de Santiago Facultad de Medicina Clínica Alemana Universidad del Desarrollo Santiago Chile.'}, {'ForeName': 'Verónica V', 'Initials': 'VV', 'LastName': 'Olavarría', 'Affiliation': '3 Servicio de Neurología Departamento de Neurología y Psiquiatría Alemana de Santiago Facultad de Medicina Clínica Alemana Universidad del Desarrollo Santiago Chile.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Brunser', 'Affiliation': '3 Servicio de Neurología Departamento de Neurología y Psiquiatría Alemana de Santiago Facultad de Medicina Clínica Alemana Universidad del Desarrollo Santiago Chile.'}, {'ForeName': 'Octavio', 'Initials': 'O', 'LastName': 'Pontes-Neto', 'Affiliation': '9 Stroke Service Neurology Division Ribeirão Preto Medical School University of São Paulo Ribeirão Preto Brazil.'}, {'ForeName': 'Taiza E G', 'Initials': 'TEG', 'LastName': 'Santos', 'Affiliation': '9 Stroke Service Neurology Division Ribeirão Preto Medical School University of São Paulo Ribeirão Preto Brazil.'}, {'ForeName': 'Hisatomi', 'Initials': 'H', 'LastName': 'Arima', 'Affiliation': '10 Department of Preventive Medicine and Public Health Faculty of Medicine Fukuoka University Fukuoka Japan.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': '1 The George Institute for Global Health Faculty of Medicine University of New South Wales Sydney Australia.'}, {'ForeName': 'Maree L', 'Initials': 'ML', 'LastName': 'Hackett', 'Affiliation': '1 The George Institute for Global Health Faculty of Medicine University of New South Wales Sydney Australia.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': '1 The George Institute for Global Health Faculty of Medicine University of New South Wales Sydney Australia.'}, {'ForeName': 'Thompson', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': '11 Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Center University of Leicester United Kingdom.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': '1 The George Institute for Global Health Faculty of Medicine University of New South Wales Sydney Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Heart Association,['10.1161/JAHA.119.012640']
366,30648318,Effects of evening exposure to electromagnetic fields emitted by 3G mobile phones on health and night sleep EEG architecture.,"Studies on sleep after exposure to radiofrequency electromagnetic fields have shown mixed results. We investigated the effects of double-blind radiofrequency exposure to 1,930-1,990 MHz, UMTS 3G signalling standard, time-averaged 10 g specific absorption rate of 1.6 W kg -1  on self-evaluated sleepiness and objective electroencephalogram architecture during sleep. Eighteen subjects aged 18-19 years underwent 3.0 hr of controlled exposure on two consecutive days 19:45-23:00 hours (including 15-min break); active or sham prior to sleep, followed by full-night 7.5 hr polysomnographic recordings in a sleep laboratory. In a cross-over design, the procedure was repeated a week later with the second condition. The results for sleep electroencephalogram architecture showed no change after radiofrequency exposure in sleep stages compared with sham, but power spectrum analyses showed a reduction of activity within the slow spindle range (11.0-12.75 Hz). No differences were found for self-evaluated health symptoms, performance on the Stroop colour word test during exposure or for sleep quality. These results confirm previous findings that radiofrequency post-exposure in the evening has very little influence on electroencephalogram architecture but possible on spindle range activity.",2019,"No differences were found for self-evaluated health symptoms, performance on the Stroop colour word test during exposure or for sleep quality.",['Eighteen subjects aged 18-19\u2005years underwent 3.0\u2005hr of controlled exposure on two'],"['consecutive days 19:45-23:00\u2005hours (including 15-min break); active or sham prior to sleep, followed by full-night 7.5\u2005hr polysomnographic recordings']","['self-evaluated health symptoms, performance on the Stroop colour word test during exposure or for sleep quality', 'health and night sleep EEG architecture']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0582675', 'cui_str': 'Stroop neuropsychological screening test (assessment scale)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0200101', 'cui_str': 'Sleep electroencephalogram (procedure)'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}]",18.0,0.0327882,"No differences were found for self-evaluated health symptoms, performance on the Stroop colour word test during exposure or for sleep quality.","[{'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Lowden', 'Affiliation': 'Stress Research Institute, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Nagai', 'Affiliation': 'Stress Research Institute, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Torbjörn', 'Initials': 'T', 'LastName': 'Åkerstedt', 'Affiliation': 'Stress Research Institute, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Kjell', 'Initials': 'K', 'LastName': 'Hansson Mild', 'Affiliation': 'Department of Radiation Sciences, Radiation Physics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Hillert', 'Affiliation': 'Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}]",Journal of sleep research,['10.1111/jsr.12813']
367,30676671,A randomized controlled trial of bedtime music for insomnia disorder.,"Music is often used as a self-help tool to alleviate insomnia. To evaluate the effect of bedtime music listening as a strategy for improving insomnia, we conducted an assessor-blinded randomized controlled trial. Fifty-seven persons with insomnia disorder were included and randomized to music intervention (n = 19), audiobook control (n = 19) or a waitlist control group (n = 19). The primary outcome measure was the Insomnia Severity Index. In addition, we used polysomnography and actigraphy to evaluate objective measures of sleep, and assessed sleep quality and quality of life. The results showed no clear effect of music on insomnia symptoms as the group × time interaction only approached significance (effect size = 0.71, p = .06), though there was a significant improvement in insomnia severity within the music group. With regard to the secondary outcomes, we found a significant effect of the music intervention on perceived sleep improvement and quality of life, but no changes in the objective measures of sleep. In conclusion, music listening at bedtime appears to have a positive impact on sleep perception and quality of life, but no clear effect on insomnia severity. Music is safe and easy to administer, but further research is needed to assess the effect of music on different insomnia subtypes, and as an adjunctive or preventive intervention.",2019,"The results showed no clear effect of music on insomnia symptoms as the group × time interaction only approached significance (effect size = 0.71, p = .06), though there was a significant improvement in insomnia severity within the music group.","['Fifty-seven persons with insomnia disorder', 'insomnia disorder']","['audiobook control', 'music intervention', 'bedtime music listening', 'waitlist control group', 'bedtime music']","['insomnia severity', 'sleep improvement and quality of life', 'sleep perception and quality of life', 'sleep quality and quality of life', 'objective measures of sleep', 'insomnia symptoms', 'Insomnia Severity Index']","[{'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}]",57.0,0.213815,"The results showed no clear effect of music on insomnia symptoms as the group × time interaction only approached significance (effect size = 0.71, p = .06), though there was a significant improvement in insomnia severity within the music group.","[{'ForeName': 'Kira Vibe', 'Initials': 'KV', 'LastName': 'Jespersen', 'Affiliation': 'Department of Clinical Medicine, Center for Music in the Brain, Aarhus University & the Royal Academy of Music, Aarhus/Aalborg, Denmark.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Otto', 'Affiliation': 'Department of Clinical Neurophysiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Kringelbach', 'Affiliation': 'Department of Clinical Medicine, Center for Music in the Brain, Aarhus University & the Royal Academy of Music, Aarhus/Aalborg, Denmark.'}, {'ForeName': 'Eus', 'Initials': 'E', 'LastName': 'Van Someren', 'Affiliation': 'Department of Sleep and Cognition, Netherlands Institute for Neuroscience, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vuust', 'Affiliation': 'Department of Clinical Medicine, Center for Music in the Brain, Aarhus University & the Royal Academy of Music, Aarhus/Aalborg, Denmark.'}]",Journal of sleep research,['10.1111/jsr.12817']
368,31215299,Efficacy of Long-Term Remote Ischemic Conditioning on Vascular and Neuronal Function in Type 2 Diabetes Patients With Peripheral Arterial Disease.,"Background Peripheral artery disease is a major socioeconomic challenge in the diabetes mellitus community and non-surgical treatment options are limited. As remote ischemic conditioning ( RIC ) improves vascular function and attenuates ischemia-induced tissue damage, we investigated the efficacy of RIC on vascular and neuronal function in type 2 diabetes mellitus patients with peripheral artery disease. Methods and Results We enrolled 36 type 2 diabetes mellitus patients with moderately reduced toe pressure (40-70 mm Hg) in a randomized sham-controlled double-masked trial. Patients were allocated to 12 weeks once daily upper arm cuff-based treatment of either RIC treatment (4 cycles of 5-minute ischemia followed by 5-minute reperfusion) or similar sham-device treatment. Primary outcome was transcutaneous tissue oxygen tension of the instep of the feet. Secondary outcomes were aortic pulse wave velocity, toe pressure and toe-brachial index. Tertiary outcomes were markers of peripheral and autonomic nerve function. We enrolled 36 patients (83% men). Patients had a mean ( SD ) age of 70.7 years (6.8), diabetes mellitus duration of 18.4 years (8.3), HbA1c (gycated hemoglobin) of 59.7 mmol/mol (11.2). Eighty percent had peripheral symmetrical neuropathy. The mean difference in change of transcutaneous tissue oxygen tension from baseline between the RIC and sham-treated groups was -0.03 mm Hg ([95% CI -0.1; 0.04], P=0.438). RIC did not elicit any change in additional outcomes. Three patients experienced transient skin petechiae in the treated arm. Conclusions Long-term repeated remote ischemic conditioning treatment have no effect on tissue oxygenation, vascular or neuronal function in patients with type 2 diabetes mellitus and moderate peripheral artery disease. Clinical Trial Registration URL : http://www.ClinicalTrials.gov . Unique identifier: NCT02749942.",2019,"Conclusions Long-term repeated remote ischemic conditioning treatment have no effect on tissue oxygenation, vascular or neuronal function in patients with type 2 diabetes mellitus and moderate peripheral artery disease.","['type 2 diabetes mellitus patients with peripheral artery disease', 'patients with type 2 diabetes mellitus and moderate peripheral artery disease', 'Patients had a mean ( SD ) age of 70.7\xa0years (6.8), diabetes mellitus duration of 18.4\xa0years (8.3), HbA1c (gycated hemoglobin) of 59.7\xa0mmol/mol (11.2', 'We enrolled 36 patients (83% men', 'Type 2 Diabetes Patients With Peripheral Arterial Disease', '36 type 2 diabetes mellitus patients with moderately reduced toe pressure (40-70\xa0mm\xa0Hg', 'Hg ']","['remote ischemic conditioning ( RIC ', 'RIC', 'Long-Term Remote Ischemic Conditioning', 'RIC treatment (4 cycles of 5-minute ischemia followed by 5-minute reperfusion) or similar sham-device treatment']","['transcutaneous tissue oxygen tension of the instep of the feet', 'transcutaneous tissue oxygen tension', 'aortic pulse wave velocity, toe pressure and toe-brachial index', 'Vascular and Neuronal Function', 'transient skin petechiae', 'tissue oxygenation, vascular or neuronal function', 'markers of peripheral and autonomic nerve function', 'peripheral symmetrical neuropathy']","[{'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C4517531', 'cui_str': '11.2 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0040357', 'cui_str': 'Toes'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial (procedure)'}, {'cui': 'C0230472', 'cui_str': 'Structure of medial arch of foot (instep)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0040357', 'cui_str': 'Toes'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C2116889', 'cui_str': 'Toe Brachial Index'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0031256', 'cui_str': 'Petechia (morphologic abnormality)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0206250', 'cui_str': 'Autonomic Nerves'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}]",36.0,0.44541,"Conclusions Long-term repeated remote ischemic conditioning treatment have no effect on tissue oxygenation, vascular or neuronal function in patients with type 2 diabetes mellitus and moderate peripheral artery disease.","[{'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Hansen', 'Affiliation': '1 Steno Diabetes Center Copenhagen Gentofte Denmark.'}, {'ForeName': 'Marit E', 'Initials': 'ME', 'LastName': 'Jørgensen', 'Affiliation': '1 Steno Diabetes Center Copenhagen Gentofte Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Fleischer', 'Affiliation': '3 Clinical Institute of Medicine Aarhus University Aarhus Denmark.'}, {'ForeName': 'Hans Erik', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': '4 Department of Cardiology Aarhus University Hospital Aarhus N Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': '1 Steno Diabetes Center Copenhagen Gentofte Denmark.'}]",Journal of the American Heart Association,['10.1161/JAHA.118.011779']
369,32120134,Intraoperative intravenous ibuprofen use is not associated with increased post-tonsillectomy bleeding.,"OBJECTIVES


Intravenous (IV) ibuprofen was approved by the FDA for use in pediatric patients in November 2015. The objective of this study was to compare bleeding rates in pediatric tonsillectomy patients who received intraoperative intravenous ibuprofen versus those who did not. Secondary objectives included analyzing factors that correlated with return to the Emergency Department (ED) for pain or dehydration.
METHODS


Charts were reviewed for all patients 0-18 years of age who underwent a tonsillectomy with or without adenoidectomy at a tertiary care children's hospital from 1/1/2017 through 5/21/2018. Demographic information and perioperative medications including the use of intraoperative intravenous ibuprofen were recorded. ED visits and operating room (OR) returns for bleeding were tracked for up to 30 days after surgery.
RESULTS


1085 charts were analyzed. Intraoperative IV ibuprofen was used in 132 cases (12.2%). Primary bleeds, defined as bleeding within 24 h of surgery, occurred in 1 (0.76%) of 132 patients who received IV ibuprofen, and 1 (0.10%) of 953 patients who did not receive IV ibuprofen. Secondary bleeds, defined as bleeds after 24 h from surgery occurred in 2 (1.52%) of 132 patients who received IV ibuprofen and 38 (3.99%) of 953 patients who did not receive IV ibuprofen. No statistical difference was found between the two groups in rates of overall (primary plus secondary) bleeding requiring return to ED (p = 0.759) or return to OR (p = 0.710).
CONCLUSION


The observed bleeding rate after pediatric tonsillectomy was not statistically different in patients who received intraoperative IV ibuprofen versus those who did not receive this medication.
LEVEL OF EVIDENCE


III.",2020,"No statistical difference was found between the two groups in rates of overall (primary plus secondary) bleeding requiring return to ED (p = 0.759) or return to OR (p = 0.710).
","['Charts were reviewed for all patients 0-18 years of age who underwent a', 'pediatric patients in November 2015', 'pediatric tonsillectomy patients who received', '1085 charts were analyzed', ""at a tertiary care children's hospital from 1/1/2017 through 5/21/2018""]","['IV ibuprofen', 'ibuprofen', 'tonsillectomy with or without adenoidectomy', 'intraoperative intravenous ibuprofen', 'Intraoperative IV ibuprofen', 'intraoperative IV ibuprofen']","['ED visits and operating room (OR) returns for bleeding', 'bleeding rate', 'bleeding rates', 'bleeds after 24\xa0h from surgery', 'factors that correlated with return to the Emergency Department (ED) for pain or dehydration', 'bleeding within 24\xa0h of surgery', 'rates of overall (primary plus secondary) bleeding requiring return to ED']","[{'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0001425', 'cui_str': 'Adenoidectomy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",1085.0,0.0687079,"No statistical difference was found between the two groups in rates of overall (primary plus secondary) bleeding requiring return to ED (p = 0.759) or return to OR (p = 0.710).
","[{'ForeName': 'Nikunj K', 'Initials': 'NK', 'LastName': 'Patel', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Sharan J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Nam K', 'Initials': 'NK', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, University of Colorado Hospital, University of Colorado-Denver School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Veronica P', 'Initials': 'VP', 'LastName': 'Carullo', 'Affiliation': 'Department of Anesthesiology, Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Christina J', 'Initials': 'CJ', 'LastName': 'Yang', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA; Department of Otorhinolaryngology - Head and Neck Surgery, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA. Electronic address: chyan@montefiore.org.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.109965']
370,32135208,"Dupilumab treatment results in early and sustained improvements in itch in adolescents and adults with moderate to severe atopic dermatitis: Analysis of the randomized phase 3 studies SOLO 1 and SOLO 2, AD ADOL, and CHRONOS.","BACKGROUND


Pruritus (itch) is a cardinal symptom in atopic dermatitis (AD).
OBJECTIVE


To evaluate the timing and effect of dupilumab on itch.
METHODS


Analysis of data from 1505 patients with moderate to severe AD included in 4 randomized controlled studies, treated for up to 52 weeks. Adults received dupilumab 300 mg every 2 weeks or placebo monotherapy (SOLO 1: NCT02277743; SOLO 2: NCT02277769), with concomitant topical corticosteroids (CHRONOS: NCT02260986); adolescents (≥12 to <18 y) were treated with dupilumab monotherapy every 2 weeks (200 mg for baseline weight of <60 kg; 300 mg for baseline weight of ≥60 kg) or placebo (AD ADOL: NCT03054428).
RESULTS


Dupilumab showed significant rapid improvements from baseline in daily Peak Pruritus Numerical Rating Scale scores versus placebo, by day 2 in adults and day 5 in adolescents. At treatment end, dupilumab vs placebo/control had greater least-squares mean percent change from baseline in the weekly average of Peak Pruritus Numerical Rating Scale scores: SOLO -47.5% vs -20.5%; AD-ADOL -47.9% vs -19.0%; CHRONOS -57.3% vs -30.9% (P < .0001 for all).
LIMITATIONS


Short duration of monotherapy trials (16 weeks).
CONCLUSION


Across 4 randomized trials, dupilumab treatment showed rapid and sustained improvements in the magnitude of itch, starting with first dose; responses progressively increased and were sustained through to the end of treatment, up to 1 year.",2020,"RESULTS


Dupilumab showed significant rapid improvements from baseline in daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores vs placebo, by day 2 in adults and day 5 in adolescents.","['adolescents and adults with moderate-to-severe atopic dermatitis', 'atopic dermatitis (AD', '1,505 patients with moderate-to-severe AD']","['dupilumab monotherapy q2w', 'placebo', 'dupilumab', 'dupilumab 300 mg every 2 weeks (q2w) or placebo monotherapy', 'dupilumab vs placebo']","['magnitude of itch, starting with first dose; responses progressively', 'daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",1505.0,0.55959,"RESULTS


Dupilumab showed significant rapid improvements from baseline in daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores vs placebo, by day 2 in adults and day 5 in adolescents.","[{'ForeName': 'Jonathan I', 'Initials': 'JI', 'LastName': 'Silverberg', 'Affiliation': 'Department of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC. Electronic address: jonathanisilverberg@gmail.com.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Yosipovitch', 'Affiliation': 'Department of Dermatology and Itch Center, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': 'Division of Dermatology, Department of Medicine, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Jashin J', 'Initials': 'JJ', 'LastName': 'Wu', 'Affiliation': 'Dermatology Research and Education Foundation, Irvine, California.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Eckert', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Guillemin', 'Affiliation': 'Sanofi, Lyon, France.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Ardeleanu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Mandeep', 'Initials': 'M', 'LastName': 'Kaur', 'Affiliation': 'Sanofi Genzyme, Cambridge, Massachusetts.'}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Rossi', 'Affiliation': 'Sanofi Genzyme, Cambridge, Massachusetts.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Naimish', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Sanofi, Cambridge, Massachusetts.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Gadkari', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.02.060']
371,31931884,"Design of a randomized controlled trial to Link Infectious and Narcology Care (LINC-II) in St. Petersburg, Russia.","BACKGROUND


If Russia is to achieve the UNAIDS 90-90-90 HIV targets, better approaches to engage, effectively treat, and retain patients in care are needed. This paper describes the protocol of a randomized controlled trial (RCT) testing the effectiveness of LINC-II, a strength-based case management program for HIV-positive people who inject drugs (PWID) to increase rates of HIV viral suppression, ART initiation, and opioid abstinence.
METHODS


This RCT will enroll and randomize 240 participants, recruited from a narcology (addiction care) hospital in St. Petersburg, Russia. Participants are randomized to the intervention or control arms. Those in the intervention arm receive: (1) strengths-based HIV case management supporting coordinated care; (2) rapid ART initiation; and (3) pharmacotherapy for opioid use disorder. We will evaluate the intervention's effectiveness compared to standard of care on the following outcomes: (1) undetectable HIV viral load at 12 months (primary); (2) initiation of ART within 28 days of randomization; (3) change in CD4 count from baseline to 12 months; (4) retention in HIV care (i.e., ≥ 1 visit to medical care in 2 consecutive 6 month periods); (5) undetectable HIV viral load at 6 months; and (6) past 30-day opioid abstinence (at 6 and at 12 months).
DISCUSSION


This RCT will assess the LINC-II intervention in an urban Russian setting. If effective, it will offer a new approach for increasing the uptake of both HIV and opioid use disorder treatment and coordination of these modalities in standard Eastern European clinical settings. Trial registration This study was registered with ClinicalTrials.gov through the National Institutes of Health, NCT03290391. Registered 19 September 2017, https://clinicaltrials.gov/ct2/show/NCT03290391.",2020,"If effective, it will offer a new approach for increasing the uptake of both HIV and opioid use disorder treatment and coordination of these modalities in standard Eastern European clinical settings.","['HIV-positive people who inject drugs (PWID', '240 participants, recruited from a narcology (addiction care) hospital in St. Petersburg, Russia']","['Narcology Care (LINC-II', 'LINC-II, a strength-based case management program']","['CD4 count', '30-day opioid abstinence']","[{'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0035970', 'cui_str': 'Russian Federation (Europe)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085971', 'cui_str': 'Case Management'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]",240.0,0.168989,"If effective, it will offer a new approach for increasing the uptake of both HIV and opioid use disorder treatment and coordination of these modalities in standard Eastern European clinical settings.","[{'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Gnatienko', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, Boston Medical Center, 801 Massachusetts Avenue, 2nd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Lioznov', 'Affiliation': ""Pavlov University, L'va Tolstogo St. 6-8, St. Petersburg, 197022, Russian Federation.""}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Raj', 'Affiliation': 'Center On Gender Equity and Health, Department of Medicine, University of California San Diego, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Blokhina', 'Affiliation': ""Pavlov University, L'va Tolstogo St. 6-8, St. Petersburg, 197022, Russian Federation.""}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Rosen', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Debbie M', 'Initials': 'DM', 'LastName': 'Cheng', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, 801 Massachusetts Avenue, 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Lunze', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, Boston University School of Medicine/Boston Medical Center, 801 Massachusetts Avenue, 2nd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Bendiks', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, Boston Medical Center, 801 Massachusetts Avenue, 2nd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Ve', 'Initials': 'V', 'LastName': 'Truong', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, Boston Medical Center, 801 Massachusetts Avenue, 2nd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Bushara', 'Affiliation': ""Pavlov University, L'va Tolstogo St. 6-8, St. Petersburg, 197022, Russian Federation.""}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Toussova', 'Affiliation': ""Pavlov University, L'va Tolstogo St. 6-8, St. Petersburg, 197022, Russian Federation.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Quinn', 'Affiliation': 'Biostatistics and Epidemiology Data Analytics Center, Boston University School of Public Health, 85 East Newton Street, M921, Boston, MA, 02118, USA.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Krupitsky', 'Affiliation': ""Pavlov University, L'va Tolstogo St. 6-8, St. Petersburg, 197022, Russian Federation.""}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Samet', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, Boston University School of Medicine/Boston Medical Center, 801 Massachusetts Avenue, 2nd Floor, Boston, MA, 02118, USA. jsamet@bu.edu.'}]",Addiction science & clinical practice,['10.1186/s13722-020-0179-8']
372,31077425,Therapeutic concentration achievement and allograft survival comparing usage of conventional tacrolimus doses and CYP3A5 genotype-guided doses in renal transplantation patients.,"AIMS


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


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


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


Determination of the CYP3A5 genotype improved therapeutic range achievement. CYP3A5*1/*1 patients who have high risks of DGF should be closely monitored because of an increased risk of DGF and reduced glomerular filtration rate with high tacrolimus doses.",2019,"There were no significant differences of glomerular filtration rates or graft or patient survivals over a median 37-month follow-up period.
","['renal transplantation patients', '63 cases of the']",['conventional tacrolimus'],"['delayed graft functions (DGFs', 'glomerular filtration rates or graft or patient survivals', 'Therapeutic concentration achievement and allograft survival', 'therapeutic range achievement', 'ischaemic time and higher serum donor creatinine levels', 'glomerular filtration rate', 'proportion of patients with tacrolimus concentrations', 'proportion of over-therapeutic concentration patients']","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]","[{'cui': 'C1566590', 'cui_str': 'Delayed Graft Function'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0428279', 'cui_str': 'Finding of creatinine level (finding)'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]",,0.0421589,"There were no significant differences of glomerular filtration rates or graft or patient survivals over a median 37-month follow-up period.
","[{'ForeName': 'Sirirat', 'Initials': 'S', 'LastName': 'Anutrakulchai', 'Affiliation': 'Division of Nephrology, Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Cholatip', 'Initials': 'C', 'LastName': 'Pongskul', 'Affiliation': 'Division of Nephrology, Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Kittrawee', 'Initials': 'K', 'LastName': 'Kritmetapak', 'Affiliation': 'Division of Nephrology, Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Chulaporn', 'Initials': 'C', 'LastName': 'Limwattananon', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Thailand.'}, {'ForeName': 'Suda', 'Initials': 'S', 'LastName': 'Vannaprasaht', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}]",British journal of clinical pharmacology,['10.1111/bcp.13980']
373,31108564,The effect of providing prescribing recommendations on appropriate prescribing: A cluster-randomized controlled trial in older adults in a preoperative setting.,"AIMS


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


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


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


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


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


Prescribing recommendations generated with the help of STRIP Assistant improved appropriate prescribing in a preoperative geriatric outpatient clinic but did not affect postoperative mortality.",2019,"Significantly more medication changes because of PPOs and PIMs were made in the intervention group than in the control group (PPOs 26.2% vs 3.4%, odds ratio 0.04 [95% confidence interval 0.003-0.46] P < .05; PIMS 46.2% vs 15.3% odds ratio 0.14 [95% confidence interval 0.07-0.57] P < .005).","['older adults in a preoperative setting', 'Residents who performed a comprehensive geriatric assessment', 'preoperative geriatric outpatient clinic', '65 intervention and 59 control patients were included, attended by 34 residents', 'Visiting patients aged 70\xa0years or older on 5 or more medications were included']",['STRIP Assistant'],"['postoperative mortality', 'PPOs and PIMs', 'number of medication changes made because of potential prescribing omissions (PPOs), potentially inappropriate medications (PIMs), and suboptimal dosages according to the prescribing recommendations']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0017463', 'cui_str': 'Geriatric Assessment'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1321564', 'cui_str': 'Strip'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0580105', 'cui_str': 'Change of medication'}, {'cui': 'C4042848', 'cui_str': 'Potentially Inappropriate Medications'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}]",,0.0735976,"Significantly more medication changes because of PPOs and PIMs were made in the intervention group than in the control group (PPOs 26.2% vs 3.4%, odds ratio 0.04 [95% confidence interval 0.003-0.46] P < .05; PIMS 46.2% vs 15.3% odds ratio 0.14 [95% confidence interval 0.07-0.57] P < .005).","[{'ForeName': 'Marijke Nynke', 'Initials': 'MN', 'LastName': 'Boersma', 'Affiliation': 'Department of Geriatrics and Expertise Centre Pharmacotherapy in Old Persons (EPHOR), UMC Utrecht, The Netherlands.'}, {'ForeName': 'Corlina Johanna Alida', 'Initials': 'CJA', 'LastName': 'Huibers', 'Affiliation': 'Department of Geriatrics and Expertise Centre Pharmacotherapy in Old Persons (EPHOR), UMC Utrecht, The Netherlands.'}, {'ForeName': 'Anna Clara', 'Initials': 'AC', 'LastName': 'Drenth-van Maanen', 'Affiliation': 'Department of Geriatrics and Expertise Centre Pharmacotherapy in Old Persons (EPHOR), UMC Utrecht, The Netherlands.'}, {'ForeName': 'Mariëlle Henriëtte', 'Initials': 'MH', 'LastName': 'Emmelot-Vonk', 'Affiliation': 'Department of Geriatrics and Expertise Centre Pharmacotherapy in Old Persons (EPHOR), UMC Utrecht, The Netherlands.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Wilting', 'Affiliation': 'Department of Clinical Pharmacy, UMC Utrecht, The Netherlands.'}, {'ForeName': 'Wilma', 'Initials': 'W', 'LastName': 'Knol', 'Affiliation': 'Department of Geriatrics and Expertise Centre Pharmacotherapy in Old Persons (EPHOR), UMC Utrecht, The Netherlands.'}]",British journal of clinical pharmacology,['10.1111/bcp.13987']
374,31141195,Population pharmacokinetics of abacavir and lamivudine in severely malnourished human immunodeficiency virus-infected children in relation to treatment outcomes.,"AIMS


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


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


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


Increases in Abacavir's CL/F between day 1 to day 14, bioavailability and PK variability with early start of ART was found in this cohort of severely malnourished children; however, these changes did not influence virological outcomes. The study supports the use of weight-band dosage tables.",2019,"PK exposure did not correlate with virological outcomes or death at 12 or 48 weeks.
","['75 paediatric patients aged 0.1-10.8 (median 1.4) years', 'Severely malnourished human immunodeficiency virus-infected children', 'malnourished paediatric patients and relate to viral load outcomes after 12 and 48\xa0weeks of treatment', 'severely malnourished human immunodeficiency virus-infected children']","['lamivudine PK', 'abacavir and lamivudine', 'antiretroviral drugs abacavir and lamivudine', 'Abacavir PK', 'Abacavir and lamivudine', 'antiretroviral treatment (ART) using World Health Organization weight-band dosages']","['bioavailability and PK variability', 'total body weight', 'bioavailability', 'Apparent clearance (CL/F, L/h/7\xa0kg) of abacavir', 'virological outcomes or death']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0663655', 'cui_str': 'abacavir'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}]","[{'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0663655', 'cui_str': 'abacavir'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",75.0,0.0908955,"PK exposure did not correlate with virological outcomes or death at 12 or 48 weeks.
","[{'ForeName': 'Moherndran', 'Initials': 'M', 'LastName': 'Archary', 'Affiliation': 'Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Mcllleron', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Raziya', 'Initials': 'R', 'LastName': 'Bobat', 'Affiliation': 'Department of Paediatrics and Children Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'LaRussa', 'Affiliation': 'Department of Paediatrics, College of Physicians & Surgeons, Columbia University, New York, New York, USA.'}, {'ForeName': 'Thobekile', 'Initials': 'T', 'LastName': 'Sibaya', 'Affiliation': 'Department of Paediatrics and Children Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Lubbe', 'Initials': 'L', 'LastName': 'Wiesner', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hennig', 'Affiliation': 'School of Pharmacy, The University of Queensland, Brisbane, QLD, Australia.'}]",British journal of clinical pharmacology,['10.1111/bcp.13998']
375,32304832,"Efficacy and Safety of Ragweed SLIT-Tablet in Children with Allergic Rhinoconjunctivitis in a Randomized, Placebo-Controlled Trial.","BACKGROUND


Ragweed sublingual immunotherapy (SLIT) tablet reduces symptoms and symptom-relieving medication use in adults with allergic rhinitis with or without conjunctivitis (AR/C) but has not been evaluated in children.
OBJECTIVE


This international, multicenter, double-blind, placebo-controlled trial evaluated the efficacy and safety of ragweed SLIT-tablet in children with AR/C.
METHODS


Children (N = 1025; 77.7% polysensitized) aged 5 to 17 years with ragweed pollen-induced AR/C with or without asthma (FEV 1  ≥80% predicted) were randomized 1:1 to daily ragweed SLIT-tablet (12 Amb a 1-Unit) or placebo for up to 28 weeks (NCT02478398). The primary end point was the average total combined score (TCS; sum of rhinoconjunctivitis daily symptom score [DSS] and daily medication score [DMS]) during peak ragweed pollen season (RPS). Key secondary end points were TCS during the entire RPS, and DSS and DMS during the peak RPS.
RESULTS


Relative TCS (95% CI) improvements with ragweed SLIT-tablet versus placebo were -38.3% (-46.0% to -29.7%; least square [LS] mean difference, -2.73; P < .001) during peak RPS and -32.4% (-40.7% to -23.3%; LS mean difference, -1.86; P < .001) during the entire RPS. DSS and DMS during peak RPS improved with SLIT-tablet versus placebo by -35.4% (-43.2% to -26.1%; LS mean difference, -1.40; P < .001) and -47.7% (-59.8% to -32.5%; LS mean difference, -1.84; P < .001), respectively. Asthma DSS, short-acting β-agonist use, and nocturnal awakenings during peak RPS improved with SLIT-tablet versus placebo by -30.7%, -68.1%, and -75.1%, respectively (all nominal P ≤ .02). No events of anaphylaxis, airway compromise, or severe treatment-related systemic allergic reactions were reported.
CONCLUSIONS


Ragweed SLIT-tablet significantly improved symptoms and decreased symptom-relieving medication use in children with ragweed pollen-induced AR/C and was well tolerated.",2020,Ragweed SLIT-tablet significantly improved symptoms and decreased symptom-relieving medication use in children with ragweed pollen-induced AR/C and was well tolerated.,"['Children with Allergic Rhinoconjunctivitis', 'children with AR/C.\nMETHODS\n\n\nChildren (N=1025; 77.7% polysensitized) aged 5-17 years with ragweed pollen-induced AR/C with or without asthma (FEV 1  ≥80% predicted', 'adults with allergic rhinitis with or without conjunctivitis (AR/C']","['Ragweed SLIT-Tablet', 'ragweed SLIT-tablet', 'placebo', 'SLIT-tablet versus placebo', 'Ragweed SLIT-tablet', 'Placebo', 'daily ragweed SLIT-tablet (12 Amb a 1-Unit ) or placebo']","['Efficacy and Safety', 'average total combined score (TCS; sum of rhinoconjunctivitis daily symptom score [DSS] and daily medication score [DMS]) during peak ragweed pollen season (RPS', 'DSS and DMS during peak RPS', 'anaphylaxis, airway compromise, or severe treatment-related systemic allergic reactions', 'tolerated', 'TCS during the entire RPS, and DSS and DMS during peak RPS', 'Asthma DSS, short-acting beta-agonist use, and nocturnal awakenings during peak RPS', 'efficacy and safety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0861154', 'cui_str': 'Allergic rhinoconjunctivitis'}, {'cui': 'C0009763', 'cui_str': 'Conjunctivitis'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0440357', 'cui_str': 'Ragweed pollen'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}]","[{'cui': 'C0331432', 'cui_str': 'Ambrosia'}, {'cui': 'C0184904', 'cui_str': 'Slitting'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242387', 'cui_str': 'Treacher Collins syndrome'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0440357', 'cui_str': 'Ragweed pollen'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0011195', 'cui_str': 'Déjérine-Sottas disease'}, {'cui': 'C0012384', 'cui_str': 'Succimer'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C4055482', 'cui_str': 'Airway compromise'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1736167', 'cui_str': 'Systemic allergic reaction'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0860510', 'cui_str': 'Nocturnal awakening'}]",,0.42318,Ragweed SLIT-tablet significantly improved symptoms and decreased symptom-relieving medication use in children with ragweed pollen-induced AR/C and was well tolerated.,"[{'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Nolte', 'Affiliation': 'ALK, Bedminster, NJ. Electronic address: Hendrik.nolte@alk.net.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Bernstein', 'Affiliation': 'Division of Immunology, Allergy and Rheumatology, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Harold S', 'Initials': 'HS', 'LastName': 'Nelson', 'Affiliation': 'Department of Medicine, Allergy/Immunology Service, National Jewish Health, Denver, Colo.'}, {'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Ellis', 'Affiliation': ""Division of Allergy & Immunology, Department of Medicine, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Kleine-Tebbe', 'Affiliation': 'Allergy & Asthma Center Westend, Berlin, Germany.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.03.041']
376,32273271,A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the Inpatient Management of Medicine and Surgery Patients With Type 2 Diabetes: Glargine U300 Hospital Trial.,"OBJECTIVE


The role of U300 glargine insulin for the inpatient management of type 2 diabetes (T2D) has not been determined. We compared the safety and efficacy of glargine U300 versus glargine U100 in noncritically ill patients with T2D.
RESEARCH DESIGN AND METHODS


This prospective, open-label, randomized clinical trial included 176 patients with poorly controlled T2D (admission blood glucose [BG] 228 ± 82 mg/dL and HbA 1c  9.5 ± 2.2%), treated with oral agents or insulin before admission. Patients were treated with a basal-bolus regimen with glargine U300 ( n  = 92) or glargine U100 ( n  = 84) and glulisine before meals. We adjusted insulin daily to a target BG of 70-180 mg/dL. The primary end point was noninferiority in the mean difference in daily BG between groups. The major safety outcome was the occurrence of hypoglycemia.
RESULTS


There were no differences between glargine U300 and U100 in mean daily BG (186 ± 40 vs. 184 ± 46 mg/dL,  P  = 0.62), percentage of readings within target BG of 70-180 mg/dL (50 ± 27% vs. 55 ± 29%,  P  = 0.3), length of stay (median [IQR] 6.0 [4.0, 8.0] vs. 4.0 [3.0, 7.0] days,  P  = 0.06), hospital complications (6.5% vs. 11%,  P  = 0.42), or insulin total daily dose (0.43 ± 0.21 vs. 0.42 ± 0.20 units/kg/day,  P  = 0.74). There were no differences in the proportion of patients with BG <70 mg/dL (8.7% vs. 9.5%,  P  > 0.99), but glargine U300 resulted in significantly lower rates of clinically significant hypoglycemia (<54 mg/dL) compared with glargine U100 (0% vs. 6.0%,  P  = 0.023).
CONCLUSIONS


Hospital treatment with glargine U300 resulted in similar glycemic control compared with glargine U100 and may be associated with a lower incidence of clinically significant hypoglycemia.",2020,"There were no differences between glargine U300 and U100 in mean daily BG (186 ± 40 vs. 184 ± 46 mg/dL,  P  = 0.62), percentage of readings within target BG of 70-180 mg/dL (50 ± 27% vs. 55 ± 29%,  P  = 0.3), length of stay (median [IQR] 6.0 [4.0, 8.0] vs. 4.0 [3.0, 7.0] days,  P  = 0.06), hospital complications (6.5% vs. 11%,  P  = 0.42), or insulin total daily dose (0.43 ± 0.21 vs. 0.42 ± 0.20 units/kg/day,  P  = 0.74).","['type 2 diabetes (T2D', 'Medicine and Surgery Patients With Type 2 Diabetes: Glargine U300 Hospital Trial', '176 patients with poorly controlled T2D (admission blood glucose [BG] 228 ± 82 mg/dL and HbA 1c  9.5 ± 2.2%), treated with oral agents or insulin before admission', 'noncritically ill patients with T2D.\nMETHODS']","['Glargine U300 and Glargine U100', 'U300 glargine insulin', 'glargine U300 versus glargine', 'glargine U100', 'glargine U300']","['percentage of readings within target BG', 'safety and efficacy', 'rates of clinically significant hypoglycemia', 'length of stay', 'hospital complications', 'occurrence of hypoglycemia']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",176.0,0.187812,"There were no differences between glargine U300 and U100 in mean daily BG (186 ± 40 vs. 184 ± 46 mg/dL,  P  = 0.62), percentage of readings within target BG of 70-180 mg/dL (50 ± 27% vs. 55 ± 29%,  P  = 0.3), length of stay (median [IQR] 6.0 [4.0, 8.0] vs. 4.0 [3.0, 7.0] days,  P  = 0.06), hospital complications (6.5% vs. 11%,  P  = 0.42), or insulin total daily dose (0.43 ± 0.21 vs. 0.42 ± 0.20 units/kg/day,  P  = 0.74).","[{'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Pasquel', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'M Cecilia', 'Initials': 'MC', 'LastName': 'Lansang', 'Affiliation': 'The Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'Ameer', 'Initials': 'A', 'LastName': 'Khowaja', 'Affiliation': 'Hennepin County Medical Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'M Agustina', 'Initials': 'MA', 'LastName': 'Urrutia', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Saumeth', 'Initials': 'S', 'LastName': 'Cardona', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Albury', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Rodolfo J', 'Initials': 'RJ', 'LastName': 'Galindo', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Fayfman', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Migdal', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Priyathama', 'Initials': 'P', 'LastName': 'Vellanki', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA geumpie@emory.edu.'}]",Diabetes care,['10.2337/dc19-1940']
377,31112623,"Effect of hepatic impairment on the pharmacokinetics of vilaprisan: An open-label, single-dose, parallel-group study.","AIMS


The study objective was to evaluate the pharmacokinetics of the selective progesterone receptor modulator vilaprisan in participants with hepatic impairment. Additionally, the safety and tolerability of vilaprisan were investigated.
METHODS


In this phase 1, open-label, nonrandomised, parallel-group, pharmacokinetic study, men and women with mild or moderate hepatic impairment (Child-Pugh grade A or B) and control participants with normal hepatic function matched by age, weight and sex received a single oral 2 mg dose of vilaprisan. Key pharmacokinetic parameters, relationships between parameters and safety outcomes were measured.
RESULTS


Thirty-six participants completed the study: 9 with mild hepatic impairment, 9 with moderate hepatic impairment and 18 matched control participants with normal hepatic function. Vilaprisan reached maximum plasma concentrations after 1-2 hours. Unbound vilaprisan exposure was 1.44-fold higher for participants with mild hepatic impairment vs controls (90% confidence interval: 0.91-2.26), and 1.74-fold higher for participants with moderate impairment vs controls (90% confidence interval: 1.09-2.78). The maximum observed unbound peak concentrations were similar for participants with hepatic impairment and matched controls. Vilaprisan 2 mg was well tolerated and the incidence of treatment-emergent adverse events was similar across cohorts.
CONCLUSION


Only mild increases of <1.75-fold in exposure were observed in participants with mild or moderate hepatic impairment compared with control participants. No safety concern was identified. These data, alongside the excellent safety profile observed in phase 1 and 2 studies, do not indicate that a dose adjustment would be required in patients with mild or moderate hepatic impairment.",2019,No safety concern was identified.,"['Thirty-six participants completed the study: 9 with mild hepatic impairment, 9 with moderate hepatic impairment and 18 matched control participants with normal hepatic function', 'men and women with mild or moderate hepatic impairment', 'participants with hepatic impairment', 'Child-Pugh grade A or B) and control participants with normal hepatic function matched by age, weight and sex received a', 'patients with mild or moderate hepatic impairment']","['single oral 2\xa0mg dose of vilaprisan', 'selective progesterone receptor modulator vilaprisan', 'vilaprisan']","['maximum plasma concentrations', 'tolerated and the incidence of treatment-emergent adverse events', 'safety and tolerability of vilaprisan', 'Unbound vilaprisan exposure']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0309195', 'cui_str': 'Grade A (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4508937', 'cui_str': 'vilaprisan'}, {'cui': 'C3653463', 'cui_str': 'Progesterone receptor modulators'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4508937', 'cui_str': 'vilaprisan'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",36.0,0.151187,No safety concern was identified.,"[{'ForeName': 'Niladri', 'Initials': 'N', 'LastName': 'Chattopadhyay', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Riecke', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Ligges', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Zimmermann', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Atef', 'Initials': 'A', 'LastName': 'Halabi', 'Affiliation': 'CRS Clinical Research Services GmbH, Kiel, Germany.'}, {'ForeName': 'Marcus-Hillert', 'Initials': 'MH', 'LastName': 'Schultze-Mosgau', 'Affiliation': 'Bayer AG, Berlin, Germany.'}]",British journal of clinical pharmacology,['10.1111/bcp.13992']
378,32302791,"A randomized trial to examine the mechanisms of cognitive, behavioral and mindfulness-based psychosocial treatments for chronic pain: Study protocol.","This randomized trial will evaluate the mechanisms of three chronic pain treatments: cognitive therapy (CT), mindfulness meditation (MM), and activation skills (AS). We will determine the extent to which late-treatment improvement in primary outcome (pain interference) is predicted by early-treatment changes in cognitive content, cognitive process, and/or activity level. The shared versus specific role of these mechanisms across the three treatments will be evaluated during treatment (Primary Aim), and immediately post-treatment to examine relapse mechanisms (Secondary Aim). We will enroll 300 individuals with chronic pain (with low back pain as a primary or secondary condition), with 240 projected to complete the study. Participants will be randomly assigned to eight, 1.5 h telehealth group sessions of CT, MM, or AS. Mechanisms and outcomes will be assessed twice daily during 2-week baseline, 4-week treatment period, and 4-week post-treatment epoch via random cue-elicited ecological momentary assessment (EMA); activity level will be monitored during these time epochs via daily monitoring with ActiGraph technology. The primary outcome will be measured by the PROMIS 5-item Pain Interference scale. Structural equation modeling (SEM) will be used to test the primary aims. This study is pre-registered on clinicaltrials.gov (Identifier: NCT03687762). This study will determine the temporal sequence of lagged mediation effects to evaluate rates of change in outcome as a function of change in mediators. The findings will provide an empirical basis for enhancing and streamlining psychosocial chronic pain interventions. Further, results will guide future efforts towards optimizing maintenance of gains to effectively reduce relapse risk.",2020,"We will determine the extent to which late-treatment improvement in primary outcome (pain interference) is predicted by early-treatment changes in cognitive content, cognitive process, and/or activity level.","['chronic pain', '300 individuals with chronic pain (with low back pain as a primary or secondary condition), with 240 projected to complete the study']","['Structural equation modeling (SEM', 'telehealth group sessions of CT, MM, or AS', 'chronic pain treatments: cognitive therapy (CT), mindfulness meditation (MM), and activation skills (AS', 'cognitive, behavioral and mindfulness-based psychosocial treatments']","['Pain Interference scale', 'cognitive content, cognitive process, and/or activity level', 'PROMIS 5-item']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0681947', 'cui_str': 'Structural Equation Modeling'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",300.0,0.103487,"We will determine the extent to which late-treatment improvement in primary outcome (pain interference) is predicted by early-treatment changes in cognitive content, cognitive process, and/or activity level.","[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Day', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia. Electronic address: m.day@uq.edu.au.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Ehde', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Burns', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Ward', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Friedly', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'B E', 'Initials': 'BE', 'LastName': 'Thorn', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Ciol', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mendoza', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Chan', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Battalio', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Borckardt', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Jensen', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106000']
379,32298717,Acceptability of oral dimethandrolone undecanoate in a 28-day placebo-controlled trial of a hormonal male contraceptive prototype.,"OBJECTIVE


To determine men's satisfaction with and acceptability of a once-daily, oral regimen of dimethandrolone undecanoate (DMAU) versus placebo when used for 28 days.
STUDY DESIGN


After a Phase I double-blind, randomized, placebo-controlled, dose-escalating trial of oral DMAU for 28-days, 57 healthy male volunteers completed a survey assessing their experience and satisfaction with the regimen. In the trial, participants were randomized to receive up to 4 DMAU capsules daily versus placebo and instructed to ingest them within 30 min of consuming a high fat meal. Pharmacokinetic and pharmacodynamic profiles were performed, followed by a 6-week recovery phase. Participants were counseled that they could not rely on the drug for contraception.
RESULTS


Fifty-seven participants were offered acceptability surveys (39 DMAU, 18 placebo). Most respondents, 80% (45/56), reported satisfaction with the method; 77% (44/57) would recommend it. 54% (31/57), reported that, if available, they would use the method as their primary contraceptive. More respondents reported satisfaction with active DMAU than placebo (87% vs. 67%; p = 0.05). Most respondents, 91% (52/57), reported no difficulty with having to take up to 4 pills within 30 min of ingesting a high-fat meal.
CONCLUSION


Most participants reported that the study method, daily oral DMAU or placebo, was satisfactory and acceptable. Having to take the drug after a high-fat meal did not detract from acceptability.
IMPLICATIONS


Most participants in a 4-week trial of daily DMAU capsules would recommend and use the method. High satisfaction among DMAU and placebo groups affirms acceptability of a daily male contraceptive pill, warranting further study of oral DMAU.",2020,More respondents reported satisfaction with active DMAU than placebo (87% vs. 67%; p=0.05).,"['hormonal male contraceptive prototype', '57 healthy male volunteers completed a survey assessing their experience and satisfaction with the regimen', 'Participants were counseled that they could not rely on the drug for contraception', 'Fifty-seven participants']","['oral dimethandrolone undecanoate', 'DMAU capsules daily versus placebo', 'placebo', 'oral DMAU', 'dimethandrolone undecanoate (DMAU) versus placebo', 'DMAU and placebo']",['satisfaction with active DMAU'],"[{'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009881', 'cui_str': 'Contraceptives, Male'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C4517815', 'cui_str': '57'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2974168', 'cui_str': 'dimethandrolone-undecanoate'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C2974168', 'cui_str': 'dimethandrolone-undecanoate'}]",57.0,0.422798,More respondents reported satisfaction with active DMAU than placebo (87% vs. 67%; p=0.05).,"[{'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Nguyen', 'Affiliation': 'Department of Obstetrics & Gynecology, Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA; The Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA. Electronic address: nguyenbt@usc.edu.'}, {'ForeName': 'Maritza T', 'Initials': 'MT', 'LastName': 'Farrant', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Bradley D', 'Initials': 'BD', 'LastName': 'Anawalt', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Yuen', 'Affiliation': 'The Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Arthi', 'Initials': 'A', 'LastName': 'Thirumalai', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Amory', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Swerdloff', 'Affiliation': 'The Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Bremner', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Peter Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'The Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Blithe', 'Affiliation': 'Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Stephanie T', 'Initials': 'ST', 'LastName': 'Page', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'The Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA.'}]",Contraception,['10.1016/j.contraception.2020.04.006']
380,32298853,Treatment Benefit with Omalizumab in Children by Indicators of Asthma Severity.,"BACKGROUND


Greater severity in childhood asthma negatively impacts functioning and quality of life. Omalizumab is effective in children aged 6 years or older with moderate to severe persistent asthma, but predicting responsiveness in severe disease requires further study.
OBJECTIVE


To assess response to omalizumab treatment among children using indicators of asthma severity.
METHODS


Post hoc analyses of randomized placebo-controlled studies of omalizumab (Inner-City Anti-IgE Therapy for Asthma [ICATA], IA05, and Preventative Omalizumab or Step-up Therapy for Fall Exacerbations [PROSE]) stratified by body mass index, eosinophil count, fractional exhaled nitric oxide levels, and baseline severity indicators (baseline percent predicted FEV 1 , previous hospitalizations, asthma exacerbations). Poisson regression analysis examined exacerbation rate reductions for body mass index, biomarkers, and severity indicators.
RESULTS


Children aged 6 to 11 years in IA05 (N = 576; 56% white, 17% black, 26% other/missing), ICATA (N = 237; 55% black, 43% Hispanic), and PROSE (N = 342; 59% black, 35% Hispanic) were included. Trends indicative of greater exacerbation rate change ([omalizumab - placebo]/placebo) were observed for low baseline lung function (IA05 percent predicted FEV 1 : <90%, 36% reduction, 95% CI, -53.3 to -13.5; ≥90%, 22% reduction, 95% CI, -52.1 to 27.5), previous hospitalizations (ICATA: 46% reduction with, 95% CI, -69.7 to -3.9; 24% reduction without, 95% CI, -48.1 to 10.3), frequent baseline exacerbations (IA05: ≥3, 42% reduction, 95% CI, -60.4 to -14.1; <3, 20% reduction, 95% CI, -45.2 to -15.9), and high baseline eosinophil count (IA05: ≥300 cells/μL, 39% reduction, 95% CI, -56.4 to -14.7; <300 cells/μL, 5% reduction, 95% CI, -40.6 to 52.1).
CONCLUSIONS


Omalizumab reduces exacerbations in children with moderate to severe persistent allergic asthma, and may provide greater benefit in children with more severe asthma subtypes.",2020,"Trends indicative of greater exacerbation rate change ([omalizumab-placebo]/placebo) were observed for low baseline lung function (IA05 ppFEV 1 : <90%, 36% reduction, 95%CI: -53.3,","['Children aged 6-11 years in IA05 (N=576', 'IA05: ≥300 cells/μL, 39% reduction, 95%CI: -56.4, -14.7; <300 cells/μL, 5% reduction, 95%CI: -40.6, 52.1', 'children using indicators of asthma severity', 'children with moderate-to-severe persistent allergic asthma', ' 56% White, 17% Black, 26% Other/Missing), ICATA (N=237; 55% Black, 43% Hispanic), and PROSE (N=342; 59% Black, 35% Hispanic', 'children aged ≥6 years with moderate-to-severe persistent asthma']","['Omalizumab', 'placebo', 'omalizumab']","['forced expiratory volume in 1 second [ppFEV 1 ], prior hospitalizations, asthma exacerbations', 'high baseline eosinophil count', 'body mass index (BMI), eosinophil count, fractional exhaled nitric oxide (FeNO) levels, and baseline severity indicators']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0581122', 'cui_str': 'Asthma severity'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0155877', 'cui_str': 'Allergic asthma'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",,0.524462,"Trends indicative of greater exacerbation rate change ([omalizumab-placebo]/placebo) were observed for low baseline lung function (IA05 ppFEV 1 : <90%, 36% reduction, 95%CI: -53.3,","[{'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': ""Pediatric Asthma Research Program, Breathing Institute, Children's Hospital Colorado, and University of Colorado School of Medicine, Aurora, Colo. Electronic address: Stanley.Szefler@childrenscolorado.org.""}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Casale', 'Affiliation': 'University of South Florida, Tampa, Fla.'}, {'ForeName': 'Tmirah', 'Initials': 'T', 'LastName': 'Haselkorn', 'Affiliation': 'EpiMetrix, Inc, Los Altos, Calif.'}, {'ForeName': 'Bongin', 'Initials': 'B', 'LastName': 'Yoo', 'Affiliation': 'Genentech, Inc, South San Francisco, Calif.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ortiz', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Meyer', 'Initials': 'M', 'LastName': 'Kattan', 'Affiliation': 'Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Busse', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, Wis.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.03.033']
381,32253184,"Dual neutralisation of interleukin-17A and interleukin-17F with bimekizumab in patients with active ankylosing spondylitis: results from a 48-week phase IIb, randomised, double-blind, placebo-controlled, dose-ranging study.","OBJECTIVES


Bimekizumab selectively neutralises both interleukin (IL)-17A and IL-17F. We report efficacy and safety in a phase IIb dose-ranging study in patients with active ankylosing spondylitis (AS).
METHODS


Adults with AS (fulfilling modified New York criteria) were randomised 1:1:1:1:1 to bimekizumab 16 mg, 64 mg, 160 mg, 320 mg or placebo every 4 weeks for 12 weeks (double-blind period). At week 12, patients receiving bimekizumab 16 mg, 64 mg or placebo were re-randomised 1:1 to bimekizumab 160 mg or 320 mg every 4 weeks to week 48; other patients continued on their initial dose (dose-blind period). The primary end point was Assessment of SpondyloArthritis international Society (ASAS) 40 response at week 12 (non-responder imputation (NRI) for missing data).
RESULTS


303 patients were randomised: bimekizumab 16 mg (n=61), 64 mg (n=61), 160 mg (n=60), 320 mg (n=61) or placebo (n=60). At week 12, significantly more bimekizumab-treated patients achieved ASAS40 vs placebo (NRI: 29.5%-46.7% vs 13.3%; p<0.05 all comparisons; OR vs placebo 2.6-5.5 (95% CI 1.0 to 12.9)). A significant dose-response was observed (p<0.001). The primary end point was supported by all secondary efficacy outcomes. At week 48, 58.6% and 62.3% of patients receiving bimekizumab 160 and 320 mg throughout the study achieved ASAS40, respectively (NRI); similar ASAS40 response rates were observed in re-randomised patients. During the double-blind period, treatment-emergent adverse events occurred in 26/60 (43.3%) patients receiving placebo and 92/243 (37.9%) receiving bimekizumab.
CONCLUSIONS


Bimekizumab provided rapid and sustained improvements in key outcome measures in patients with active AS, with no unexpected safety findings versus previous studies.
TRIAL REGISTRATION NUMBER


NCT02963506.",2020,"At week 48, 58.6% and 62.3% of patients receiving bimekizumab 160 and 320 mg throughout the study achieved ASAS40, respectively (NRI); similar ASAS40 response rates were observed in re-randomised patients.","['Adults with AS (fulfilling modified New York criteria', 'patients with active AS', '303 patients', 'patients with active ankylosing spondylitis', 'patients with active ankylosing spondylitis (AS']","['bimekizumab', 'placebo', 'interleukin-17A and interleukin-17F with bimekizumab', 'ASAS40 vs placebo', 'bimekizumab 16 mg, 64 mg or placebo', 'Bimekizumab']","['interleukin (IL)-17A and IL-17F', 'adverse events', 'SpondyloArthritis international Society (ASAS) 40 response', 'efficacy and safety', 'ASAS40 response rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038012', 'cui_str': 'Spondylitis'}]","[{'cui': 'C4519734', 'cui_str': 'bimekizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C1432339', 'cui_str': 'IL17F protein, human'}]","[{'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C1432339', 'cui_str': 'IL17F protein, human'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",303.0,0.70834,"At week 48, 58.6% and 62.3% of patients receiving bimekizumab 160 and 320 mg throughout the study achieved ASAS40, respectively (NRI); similar ASAS40 response rates were observed in re-randomised patients.","[{'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands mail@dvanderheijde.nl.'}, {'ForeName': 'Lianne S', 'Initials': 'LS', 'LastName': 'Gensler', 'Affiliation': 'University California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Xenofon', 'Initials': 'X', 'LastName': 'Baraliakos', 'Affiliation': 'Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Poddubnyy', 'Affiliation': 'Department of Rheumatology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin and Epidemiology Unit, German Rheumatism Research Centre, Berlin, Germany.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, Pennsylvania, USA.'}, {'ForeName': 'Mary Katherine', 'Initials': 'MK', 'LastName': 'Farmer', 'Affiliation': 'UCB Pharma, Raleigh, North Carolina, USA.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Baeten', 'Affiliation': 'Department of Clinical Immunology and Rheumatology, UCB Pharma, Slough, UK.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Goldammer', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Coarse', 'Affiliation': 'UCB Pharma, Raleigh, North Carolina, USA.'}, {'ForeName': 'Marga', 'Initials': 'M', 'LastName': 'Oortgiesen', 'Affiliation': 'UCB Pharma, Raleigh, North Carolina, USA.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Department of Rheumatology, Université de Paris, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-216980']
382,32304676,"Impact of sugar taxes and front-of-package nutrition labels on purchases of protein, calcium and fibre.","Taxes and front-of-package (FOP) labels can be effective interventions for reducing consumption of sugar, saturated fat, and sodium; however, few studies have examined their impact on intake of 'positive' nutrients. The current study explored the impact of sugar taxes and FOP labels on the protein, calcium and fibre density of snack food purchases. A total of 3584 Canadians aged 13 years and older participated in an experimental marketplace using a 3 × 8 between-within group experiment. Participants received $5 and viewed images of 20 snack food products available for purchase. Participants were randomized to one of five FOP label conditions (no label, high in, multiple traffic light, health star rating, or nutrition grade) and completed three within-subject purchasing tasks with different sugar tax conditions (no tax, 20%, tiered). Upon conclusion, participants received the product and any change from one of the purchasing tasks. The results indicate that participants purchased snack foods with higher fibre density when either sugar tax was applied (+0.1 g/100 kcal) compared to no tax, and when they were assigned to see the multiple traffic light (+0.4 g/100 kcal) or health star rating (+0.3 g/100 kcal) FOP labels, compared to no FOP label. There were no significant differences in the protein or calcium density of snack foods purchased across the tax or FOP labelling conditions. Overall, the findings suggest that as consumers respond to tax or labelling policies by moving away from sugars, sodium, and saturated fat, there may be no downside-or even an increase-in 'positive' nutrient density.",2020,There were no significant differences in the protein or calcium density of snack foods purchased across the tax or FOP labelling conditions.,['3584 Canadians aged 13\u202fyears and older participated in an experimental marketplace using a 3\u202f×\u202f8 between-within group experiment'],"['sugar taxes and front-of-package nutrition labels', 'multiple traffic light (+0.4\u202fg/100\u202fkcal) or health star rating (+0.3\u202fg/100\u202fkcal) FOP labels', 'sugar taxes and FOP labels', 'Taxes and front-of-package (FOP) labels', 'FOP label conditions (no label, high in, multiple traffic light, health star rating, or nutrition grade) and completed three within-subject purchasing tasks with different sugar tax conditions (no tax, 20%, tiered']","['purchases of protein, calcium and fibre']","[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0039371', 'cui_str': 'Tax'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0028711', 'cui_str': 'Nutrition Labeling'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0442664', 'cui_str': 'Traffic light'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}]",3584.0,0.0287178,There were no significant differences in the protein or calcium density of snack foods purchased across the tax or FOP labelling conditions.,"[{'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Acton', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, 200 University Ave W, Waterloo, ON N2L 3G1, Canada. Electronic address: rbacton@uwaterloo.ca.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hammond', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, 200 University Ave W, Waterloo, ON N2L 3G1, Canada. Electronic address: david.hammond@uwaterloo.ca.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106091']
383,32299108,"Transcervical Foley Balloon Plus Vaginal Misoprostol versus Vaginal Misoprostol Alone for Cervical Ripening in Nulliparous Obese Women: A Multicenter, Randomized, Comparative-Effectiveness Trial.","OBJECTIVE


Nulliparous obese women are at increased risk of labor induction and cesarean delivery (CD). We sought to determine whether the combination of a transvaginal Foley balloon plus misoprostol prostaglandin E1 (PGE1) is superior to misoprostol alone in reducing the risk for CD.
STUDY DESIGN


We undertook a multicenter, open-label, comparative-effectiveness randomized clinical trial of nulliparous obese women with unfavorable cervix (Bishop's score ≤ 6) undergoing labor induction from January 2016 to June 2018 at three tertiary centers. Those at <32 weeks' gestation, premature rupture of membranes, stillbirth, and major fetal anomalies were excluded. Women were randomized 1:1 to either a combination of Foley balloon and misoprostol or misoprostol alone. Once Bishop's score was >6, further management was deferred to treating physicians. Primary outcome was the rate of CD. Secondary maternal outcomes included duration of induction-to-delivery interval, occurrence of tachysystole, clinical chorioamnionitis, need for operative vaginal delivery, as well as a composite of maternal morbidity (postpartum endometritis, surgical-site infection, venous thromboembolism, need for transfusion, intensive care unit admission, and maternal death). Secondary neonatal outcomes included need for neonatal intensive care unit admission, transient tachypnea of the newborn, respiratory distress syndrome, meconium aspiration syndrome, culture-proven sepsis, neonatal seizures, and a composite of neonatal morbidity (Apgar's score ≤7 at 5 minutes, umbilical artery cord pH ≤7.10, birth injury, perinatal death). With the rate of CD rate being 53% at Children's Memorial Herman Hospital among nulliparous obese women who underwent induction of labor at ≥32 weeks and met our inclusion criteria; 250 women (125 women per group) were required to answer the study question. All analyses were by intention to treat.
RESULTS


Of the 236 women randomized, 113 (48%) were allocated to group 1 (combined Foley and PGE1) and 123 (52%) to group 2 (PGE1 alone). The rate of CD was similar between the groups (45 vs. 43%,  p  = 0.84, relative risk [RR]: 1.03, 95% CI: 0.75-1.42). There was no difference in the occurrence of tachysystole that resulted in fetal heart rate abnormalities between the groups (8.8 vs. 16.2%,  p  = 0.09, RR: 0.54, 95% CI: 0.27-1.11). The total duration of the induction-to-delivery interval was also similar between the groups (24.8 ± 13.8 vs. 24.5 ± 14.0 hours,  p  = 0.87) regardless of the mode of delivery. No differences were seen in the indications for CD and secondary maternal or neonatal outcomes.
CONCLUSION


In this trial of nulliparous obese women undergoing labor induction, cervical ripening with combined Foley balloon and PGE1 resulted in similar CD rates than ripening with vaginal PGE1 alone.
KEY POINTS


- Nulliparous obese women are at increased risk for cesarean delivery.
- Combined intravaginal misoprostol-Foley balloon versus misoprostol alone resulted in similar rates of cesarean delivery.
- Further research is warranted to determine the optimal cervical ripening strategy in this population.",2020,"The rate of CD was similar between the groups (45 vs. 43%,  p  = 0.84, relative risk [RR]: 1.03, 95% CI: 0.75-1.42).","['236 women randomized, 113 (48', 'nulliparous obese women who underwent induction of labor at ≥32 weeks and met our inclusion criteria; 250 women (125 women per group', 'Nulliparous Obese Women', 'Nulliparous obese women', ""nulliparous obese women with unfavorable cervix (Bishop's score\u2009≤\u20096) undergoing labor induction from January 2016 to June 2018 at three tertiary centers"", 'nulliparous obese women undergoing labor induction, cervical ripening with']","['combined Foley balloon and PGE1', 'Transcervical Foley Balloon Plus Vaginal Misoprostol', 'intravaginal misoprostol-Foley balloon versus misoprostol', 'Vaginal Misoprostol', 'Foley balloon and misoprostol or misoprostol alone', 'transvaginal Foley balloon plus misoprostol prostaglandin E1 (PGE1', 'misoprostol']","['indications for CD and secondary maternal or neonatal outcomes', 'risk of labor induction and cesarean delivery (CD', 'CD rate', 'total duration of the induction-to-delivery interval', 'rate of CD', 'fetal heart rate abnormalities', ""need for neonatal intensive care unit admission, transient tachypnea of the newborn, respiratory distress syndrome, meconium aspiration syndrome, culture-proven sepsis, neonatal seizures, and a composite of neonatal morbidity (Apgar's score ≤7 at 5\u2009minutes, umbilical artery cord pH ≤7.10, birth injury, perinatal death"", 'duration of induction-to-delivery interval, occurrence of tachysystole, clinical chorioamnionitis, need for operative vaginal delivery, as well as a composite of maternal morbidity (postpartum endometritis, surgical-site infection, venous thromboembolism, need for transfusion, intensive care unit admission, and maternal death', 'CD rates', 'premature rupture of membranes, stillbirth, and major fetal anomalies', 'occurrence of tachysystole']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007874', 'cui_str': 'Cervix uteri structure'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0002335', 'cui_str': 'Alprostadil'}, {'cui': 'C0442344', 'cui_str': 'Transcervical approach - uterine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach'}]","[{'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0158940', 'cui_str': 'Transitory tachypnea of newborn'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0025048', 'cui_str': 'Meconium aspiration syndrome'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0159020', 'cui_str': 'Convulsions in the newborn'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0041632', 'cui_str': 'Structure of umbilical artery'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0701826', 'cui_str': 'Perinatal death'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0008495', 'cui_str': 'Chorioamnionitis'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0269932', 'cui_str': 'Puerperal endometritis'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0015944', 'cui_str': 'Premature rupture of membranes'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",236.0,0.354511,"The rate of CD was similar between the groups (45 vs. 43%,  p  = 0.84, relative risk [RR]: 1.03, 95% CI: 0.75-1.42).","[{'ForeName': 'Oscar A', 'Initials': 'OA', 'LastName': 'Viteri', 'Affiliation': 'Department of Obstetrics and Gynecology, University of South Dakota Sanford School of Medicine, Vermillion, South Dakota.'}, {'ForeName': 'Kareem K', 'Initials': 'KK', 'LastName': 'Tabsh', 'Affiliation': 'Department of Obstetrics and Gynecology, Kern Medical Center, Bakersfield, California.'}, {'ForeName': 'Mesk A', 'Initials': 'MA', 'LastName': 'Alrais', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences, McGovern Medical School at The University of Texas Health Science Center at Houston (UT Health), Houston, Texas.'}, {'ForeName': 'Ximena C', 'Initials': 'XC', 'LastName': 'Salazar', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences, McGovern Medical School at The University of Texas Health Science Center at Houston (UT Health), Houston, Texas.'}, {'ForeName': 'Juan M', 'Initials': 'JM', 'LastName': 'Lopez', 'Affiliation': 'Department of Obstetrics and Gynecology, Kern Medical Center, Bakersfield, California.'}, {'ForeName': 'Randolph Y', 'Initials': 'RY', 'LastName': 'Fok', 'Affiliation': 'Department of Obstetrics and Gynecology, Kern Medical Center, Bakersfield, California.'}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences, McGovern Medical School at The University of Texas Health Science Center at Houston (UT Health), Houston, Texas.'}, {'ForeName': 'Baha M', 'Initials': 'BM', 'LastName': 'Sibai', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences, McGovern Medical School at The University of Texas Health Science Center at Houston (UT Health), Houston, Texas.'}]",American journal of perinatology,['10.1055/s-0040-1708805']
384,32304731,Nudging while online grocery shopping: A randomized feasibility trial to enhance nutrition in individuals with food insecurity.,"Food insecurity, the inability to acquire adequate food due to insufficient resources for food, is associated with an increased risk for obesity and associated health problems. This study assessed the feasibility and initial efficacy of a prefilled online grocery shopping cart (i.e., default option) in promoting healthier grocery purchases in individuals with food insecurity. Fifty participants recruited from food pantries in New York in 2018 were randomized to review nutrition information before purchasing groceries online (n = 23) or modify a prefilled, nutritionally balanced online shopping cart (n = 27) based on a budget corresponding to Supplemental Nutrition Assistance Program benefits. Compared to nutrition education, the default shopping cart resulted in the purchase of significantly more ounces of whole grains (Mean Difference [M diff ] = -4.05; 95% Confidence Interval [CI] = -6.14, -1.96; p < .001), cups of fruits (M diff  = -1.51; 95% CI = -2.51, -0.59; p = .002) and vegetables (M diff  = -2.21; 95% CI = -4.01, -0.41; p = .02), foods higher in fiber (mg; M diff  = -15.65; 95% CI = -27.43, -3.87; p = .01), and lower in sodium (mg; M diff  = 1642.66; 95% CI = 660.85, 2624.48; p = .002), cholesterol (mg; M diff  = 463.86; 95% CI = 198.76, 728.96; p = .001), and grams of fat (M diff  = 75.42; 95% CI = 42.81, 108.03; p < .001) and saturated fat (M diff  = 26.20; 95% CI = 14.07, 38.34; p < .001). The use of a default online shopping cart appears to improve nutritional quality of food purchases in individuals facing financial constraints.",2020,"Fifty participants recruited from food pantries in New York in 2018 were randomized to review nutrition information before purchasing groceries online (n = 23) or modify a prefilled, nutritionally balanced online shopping cart (n = 27) based on a budget corresponding to Supplemental Nutrition Assistance Program benefits.","['individuals with food insecurity', 'Fifty participants recruited from food pantries in New York in 2018 were randomized to', 'individuals facing financial constraints']","['review nutrition information before purchasing groceries online (n\u202f=\u202f23) or modify a prefilled, nutritionally balanced online shopping cart (n\u202f=\u202f27) based on a budget corresponding to Supplemental Nutrition Assistance Program benefits', 'prefilled online grocery shopping cart (i.e., default option']","['grams of fat (M diff', 'nutritional quality of food purchases', 'saturated fat', 'feasibility and initial efficacy']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3494174', 'cui_str': 'Food insecurity'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0441061', 'cui_str': 'Shopping cart'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C3494397', 'cui_str': 'SNAP Program'}]","[{'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C3489446', 'cui_str': 'Nutritive Quality'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",50.0,0.161297,"Fifty participants recruited from food pantries in New York in 2018 were randomized to review nutrition information before purchasing groceries online (n = 23) or modify a prefilled, nutritionally balanced online shopping cart (n = 27) based on a budget corresponding to Supplemental Nutrition Assistance Program benefits.","[{'ForeName': 'Jaime A', 'Initials': 'JA', 'LastName': 'Coffino', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, USA. Electronic address: jcoffino@albany.edu.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Udo', 'Affiliation': 'Department of Health Policy, Management, and Behavior, University at Albany, State University of New York, USA.'}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Hormes', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, USA.'}]",Appetite,['10.1016/j.appet.2020.104714']
385,32302790,"Comparative Healthcare Research Outcomes of Novel Surgery in prostate cancer (IP4-CHRONOS): A prospective, multi-centre therapeutic phase II parallel Randomised Control Trial.","INTRODUCTION


Focal therapy (FT) targets individual areas of cancer within the prostate, providing oncological control with minimal side-effects. Early evidence demonstrates encouraging short-medium-term outcomes. With no randomized controlled trials (RCT) comparing FT to radical therapies, Comparative Healthcare Research Outcomes of Novel Surgery in prostate cancer (CHRONOS) will compare the cancer control of these two strategies.
PATIENTS AND METHODS


CHRONOS is a parallel phase II RCT for patients with clinically significant non-metastatic prostate cancer, dependent upon clinician/patient decision, patients will enrol into either CHRONOS-A or CHRONOS-B. CHRONOS-A will randomize patients to either radical treatment or FT. CHRONOS-B is a multi-arm, multistage RCT comparing focal therapy alone to FT with neoadjuvant agents that might improve the current focal therapy outcomes. An internal pilot will determine the feasibility of, and compliance to, randomization. The proposed definitive study plans to recruit and randomize 1190 patients into CHRONOS-A and 1260 patients into CHRONOS-B.
RESULTS


Primary outcome in CHRONOS-A is progression-free survival (transition to salvage local or systemic therapy, development of metastases or prostate-cancer-related mortality) and in CHRONOS-B is failure-free survival (includes the above definition and recurrence of clinically significant prostate cancer after initial FT). Secondary outcomes include adverse events, health economics and functional outcomes measured using validated questionnaires. CHRONOS is powered to assess non-inferiority of FT compared to radical therapy in CHRONOS-A, and superiority of neoadjuvant agents with FT in CHRONOS-B.
CONCLUSION


CHRONOS will assess the oncological outcomes after FT compared to radical therapy and whether neoadjuvant treatments improve cancer control following one FT session.",2020,"CHRONOS is powered to assess non-inferiority of FT compared to radical therapy in CHRONOS-A, and superiority of neoadjuvant agents with FT in CHRONOS-B.
CONCLUSION


CHRONOS will assess the oncological outcomes after FT compared to radical therapy and whether neoadjuvant treatments improve cancer control following one FT session.","['patients with clinically significant non-metastatic prostate cancer', 'prostate cancer (IP4-CHRONOS', '1190 patients into CHRONOS-A and 1260 patients']","['Novel Surgery', 'radical treatment or FT']","['adverse events, health economics and functional outcomes measured using validated questionnaires', 'progression-free survival (transition to salvage local or systemic therapy, development of metastases or prostate-cancer-related mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C4759295', 'cui_str': 'Non-metastatic prostate cancer'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013560', 'cui_str': 'Medical Economics'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",1260.0,0.0411896,"CHRONOS is powered to assess non-inferiority of FT compared to radical therapy in CHRONOS-A, and superiority of neoadjuvant agents with FT in CHRONOS-B.
CONCLUSION


CHRONOS will assess the oncological outcomes after FT compared to radical therapy and whether neoadjuvant treatments improve cancer control following one FT session.","[{'ForeName': 'Deepika', 'Initials': 'D', 'LastName': 'Reddy', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK; Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK. Electronic address: Deepika.reddy06@imperial.ac.uk.'}, {'ForeName': 'Taimur T', 'Initials': 'TT', 'LastName': 'Shah', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK; Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Dudderidge', 'Affiliation': 'Department of Urology, University Hospital Southampton NHS Trust, Southampton, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'McCracken', 'Affiliation': 'Department of Urology, Sunderland Royal Hospital, Sunderland, UK; Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Manit', 'Initials': 'M', 'LastName': 'Arya', 'Affiliation': 'Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK; Department of Surgery and Interventional Sciences, University College London, University College Hospital, London, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Dobbs', 'Affiliation': 'Patient and Public Representative, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Emberton', 'Affiliation': 'Department of Surgery and Interventional Sciences, University College London, University College Hospital, London, UK.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Fiorentino', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Day', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, UK.'}, {'ForeName': 'Andrew Toby', 'Initials': 'AT', 'LastName': 'Prevost', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Staffurth', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sydes', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, London, UK.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Winkler', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK; Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Hashim U', 'Initials': 'HU', 'LastName': 'Ahmed', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK; Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105999']
386,31999175,Early-phase study of a telephone-based intervention to reduce weight regain among bariatric surgery patients.,"OBJECTIVE


This study describes early-phase development of a behavioral intervention to reduce weight regain following bariatric surgery. We utilized the Obesity-Related Behavioral Intervention Trials model to guide intervention development and evaluation. We sought to establish recruitment, retention, and fidelity monitoring procedures; evaluate feasibility of utilizing weight from the electronic medical record (EMR) as an outcome; observe improvement in behavioral risk factors; and evaluate treatment acceptability.
METHOD


The intervention comprised 4 weekly telephone calls addressing behavior change strategies for diet, physical activity, and nutrition supplement adherence and 5 biweekly calls addressing weight loss maintenance constructs. Veterans ( N  = 33) who received bariatric surgery 9-15 months prior consented to a 16-week, pre-post study. Self-reported outcomes were obtained by telephone at baseline and 16 weeks. Clinic weights were obtained from the EMR 6 months pre- and postconsent. Qualitative interviews were conducted at 16 weeks to evaluate treatment acceptability. We aimed to achieve a recruitment rate of ≥ 25% and retention rate of ≥ 80%, and have ≥ 50% of participants regain < 3% of their baseline weight.
RESULTS


Results supported the feasibility of recruiting (48%) and retaining participants (93% provided survey data; 100% had EMR weight). Pre-post changes in weight (73% with < 3% weight regain) and physical activity (Cohen's ds 0.38 to 0.52) supported the potential for the intervention to yield clinically significant results. Intervention adherence (mean 7.8 calls of 9 received) and positive feedback from interviews supported treatment acceptability.
CONCLUSIONS


The intervention should be evaluated in an adequately powered randomized controlled trial. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Pre-post changes in weight (73% with < 3% weight regain) and physical activity (Cohen's ds 0.38 to 0.52) supported the potential for the intervention to yield clinically significant results.,"['Veterans ( N  = 33) who received bariatric surgery 9-15 months prior consented to a 16-week, pre-post study', 'bariatric surgery patients', 'bariatric surgery']","['behavioral intervention', 'telephone calls addressing behavior change strategies for diet, physical activity, and nutrition supplement adherence and 5 biweekly calls addressing weight loss maintenance constructs', 'telephone-based intervention', 'utilizing weight from the electronic medical record (EMR']","['weight regain', 'Intervention adherence', 'physical activity', 'behavioral risk factors', 'Clinic weights', 'weight']","[{'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]",,0.0621004,Pre-post changes in weight (73% with < 3% weight regain) and physical activity (Cohen's ds 0.38 to 0.52) supported the potential for the intervention to yield clinically significant results.,"[{'ForeName': 'Corrine I', 'Initials': 'CI', 'LastName': 'Voils', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Adler', 'Affiliation': 'Department of Surgery.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Strawbridge', 'Affiliation': 'Durham Veterans Affairs Medical Center.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Grubber', 'Affiliation': 'Durham Veterans Affairs Medical Center.'}, {'ForeName': 'Kelli D', 'Initials': 'KD', 'LastName': 'Allen', 'Affiliation': 'Durham Veterans Affairs Medical Center.'}, {'ForeName': 'Maren K', 'Initials': 'MK', 'LastName': 'Olsen', 'Affiliation': 'Durham Veterans Affairs Medical Center.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'McVay', 'Affiliation': 'Department of Health Education and Behavior.'}, {'ForeName': 'Sridharan', 'Initials': 'S', 'LastName': 'Raghavan', 'Affiliation': 'Veterans Affairs Eastern Colorado Healthcare System.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Raffa', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Luke M', 'Initials': 'LM', 'LastName': 'Funk', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000835']
387,32298428,Implementing Package of Essential Non-communicable Disease Interventions in the Republic of Moldova-a feasibility study.,"BACKGROUND


The aim of this study is to determine the feasibility of implementing and evaluating the World Health Organization Package of Essential Non-communicable Disease Interventions (WHO PEN) approach in primary healthcare in the Republic of Moldova.
METHODS


According to our published a priori methods, 20 primary care clinics were randomized to 10 intervention and 10 control clinics. The intervention consisted of implementation of adapted WHO PEN guidelines and structured training for health workers; the control clinics continued with usual care. Data were gathered from paper-based patient records in July 2017 and August 2018 resulting in a total of 1174 and 995 patients in intervention and control clinics at baseline and 1329 and 1256 at follow-up. Pre-defined indicators describing assessment of risk factors and total cardiovascular risk, prescribing medications and treatment outcomes were calculated. Differences between baseline and follow-up as well as between intervention and control clinics were calculated using logistic and linear regression models and by assessing interaction effects.
RESULTS


Improvements were seen in recording smoking status, activity to measure HbA1c among diabetes patients and achieving control in hypertension treatment. Improvement was also seen in identification of patients with hypertension or diabetes. Less improvement or even deterioration was seen in assessing total risk or prescribing statins for high-risk patients.
CONCLUSIONS


It is feasible to evaluate the quality and management of patients with non-communicable diseases in low-resource settings from routine data. Modest improvements in risk factor identification and management can be achieved in a relatively short period of time.",2020,"RESULTS


Improvements were seen in recording smoking status, activity to measure HbA1c among diabetes patients and achieving control in hypertension treatment.","['primary healthcare in the Republic of Moldova', 'Data were gathered from paper-based patient records in July 2017 and August 2018 resulting in a total of 1174 and 995 patients in intervention and control clinics at baseline and 1329 and 1256 at follow-up. Pre-defined indicators describing assessment of', '20 primary care clinics', 'patients with hypertension or diabetes']",['implementation of adapted WHO PEN guidelines and structured training for health workers; the control clinics continued with usual care'],"['total risk or prescribing statins', 'risk factors and total cardiovascular risk, prescribing medications and treatment outcomes']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0026374', 'cui_str': 'Moldavia'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0205224', 'cui_str': 'Essential'}, {'cui': 'C4505065', 'cui_str': 'Non-infectious Diseases'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0218005,"RESULTS


Improvements were seen in recording smoking status, activity to measure HbA1c among diabetes patients and achieving control in hypertension treatment.","[{'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Laatikainen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Faculty of Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Inglin', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Faculty of Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Collins', 'Affiliation': 'Faculty of Medicine, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Ciobanu', 'Affiliation': 'Division of Ncds and Promoting Health through the Life Course, World Health Organization Regional Office for Europe, Copenhagen, Denmark.'}, {'ForeName': 'Ghenadie', 'Initials': 'G', 'LastName': 'Curocichin', 'Affiliation': 'Department of Family Medicine, Nicolae Testemitanu State Medical and Pharmaceutical University, Chisinau, Republic of Moldova.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Salaru', 'Affiliation': 'Department of Family Medicine, Nicolae Testemitanu State Medical and Pharmaceutical University, Chisinau, Republic of Moldova.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Zatic', 'Affiliation': 'Department of Primary, Emergency and Community Health Policies, Ministry of Health, Labour and Social Protection, Chisinau, Republic of Moldova.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Anisei', 'Affiliation': 'Department on Quality Management of Health Services, National Public Health Agency, Chisinau, Republic of Moldova.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Chiosa', 'Affiliation': 'Department of Family Medicine, Nicolae Testemitanu State Medical and Pharmaceutical University, Chisinau, Republic of Moldova.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Munteanu', 'Affiliation': 'Department of Family Medicine, Nicolae Testemitanu State Medical and Pharmaceutical University, Chisinau, Republic of Moldova.'}, {'ForeName': 'Zinaida', 'Initials': 'Z', 'LastName': 'Alexa', 'Affiliation': 'Department Endocrinology, Nicolae Testemitanu State Medical and Pharmaceutical University, Chisinau, Republic of Moldova.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Farrington', 'Affiliation': 'Division of Ncds and Promoting Health through the Life Course, World Health Organization Regional Office for Europe, Copenhagen, Denmark.'}]",European journal of public health,['10.1093/eurpub/ckaa037']
388,32301644,Verbal Motivation vs. Digital Real-Time Feedback during Cardiopulmonary Resuscitation: Comparing Bystander CPR Quality in a Randomized and Controlled Manikin Study of Simulated Cardiac Arrest.,"Objective:  The use of smartphone applications increases bystander CPR quality as well as the use of telephone CPR protocols. The present prospective, randomized, controlled manikin trial analyses the effects of a smartphone application (PocketCPR©) on CPR quality in a bystander CPR scenario compared to a dispatcher-assisted telephone CPR with the additional use of a metronome and verbal motivation.  Methods:  150 laypersons were included to perform 8-minute CPR on a manikin. Volunteers were randomly assigned to one of three groups: (1) dispatcher-assisted telephone CPR (telephone-group), (2) dispatcher-assisted telephone CPR combined with the smartphone-application (telephone + app-group) and (3) dispatcher-assisted telephone CPR with additional verbal motivation (""push harder, release completely,"" every 20 seconds, starting after 60 seconds) and a metronome with 100 min -1  (telephone + motivation-group).  Results:  Median compression depth did not differ significantly between the study groups ( p  = 0.051). However, in the post hoc analysis median compression depth in the telephone + motivation-group was significantly elevated compared to the telephone + app-group (59 mm [IQR 47-67 mm] vs. 51 mm [IQR 46-57 mm];  p  = 0.025). The median number of superficial compressions was significantly reduced in the telephone + motivation-group compared to the telephone + app-group (70 [IQR 3-362] vs. 349 [IQR 88-538];  p  = 0.004), but not compared to the telephone-group (91 [IQR 4-449];  p  = 0.707). In contrast to the other study groups, median compression depth of the telephone + motivation-group increased over time. Chest compressions with correct depth were found significantly more often in the telephone + app-group compared to the other study groups ( p  = 0.011). Median compression rate in the telephone + app-group was significantly elevated (108 min -1  [IQR 96-119 min -1 ]) compared to the telephone-group (78 min -1  [IQR 56-106 min -1 ];  p  < 0.001) and the telephone + motivation-group (99 min -1  [IQR 91-101 min -1 ];  p  < 0.001).  Conclusions:  The use of a smartphone application as well as verbal motivation by a dispatcher during telephone CPR leads to higher CPR quality levels compared to standard telephone CPR. Thereby, the use of the smartphone application mainly shows an increase in compression rate, while increased compression rate with simultaneously increased compression depth was only apparent in the telephone + motivation-group.",2020,Chest compressions with correct depth were found significantly more often in the telephone + app-group compared to the other study groups (p = 0.011).,['150 laypersons were included to perform 8-minute CPR on a manikin'],"['Verbal Motivation vs. Digital Real-Time Feedback', 'smartphone applications', 'Bystander CPR Quality', 'dispatcher-assisted telephone CPR', 'smartphone application (PocketCPR©', 'Cardiopulmonary Resuscitation', 'dispatcher-assisted telephone CPR (telephone-group), (2) dispatcher-assisted telephone CPR combined with the smartphone-application (telephone\u2009+\u2009app-group) and (3) dispatcher-assisted telephone CPR with additional verbal motivation (""push harder, release completely"", every 20\u2009seconds, starting after 60\u2009seconds) and a metronome with 100\u2009min -1  (telephone\u2009+\u2009motivation-group']","['compression depth', 'bystander CPR quality', 'compression rate', 'CPR quality', 'median number of superficial compressions', 'CPR quality levels', 'median compression depth', 'Median compression rate', 'Median compression depth']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}]","[{'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",150.0,0.0335284,Chest compressions with correct depth were found significantly more often in the telephone + app-group compared to the other study groups (p = 0.011).,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Plata', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nowack', 'Affiliation': ''}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Loeser', 'Affiliation': ''}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Drinhaus', 'Affiliation': ''}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Steinhauser', 'Affiliation': ''}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Hinkelbein', 'Affiliation': ''}, {'ForeName': 'Wolfgang A', 'Initials': 'WA', 'LastName': 'Wetsch', 'Affiliation': ''}, {'ForeName': 'Bernd W', 'Initials': 'BW', 'LastName': 'Böttiger', 'Affiliation': ''}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Spelten', 'Affiliation': 'Faculty of Medicine and University Hospital of Cologne, Department of Anesthesiology and Intensive Care Medicine, University of Cologne, Cologne, Germany (CP, MN, HD, JH, WAW, BWB).'}]",Prehospital emergency care : official journal of the National Association of EMS Physicians and the National Association of State EMS Directors,['10.1080/10903127.2020.1757181']
389,32299845,"Riociguat in patients with early diffuse cutaneous systemic sclerosis (RISE-SSc): randomised, double-blind, placebo-controlled multicentre trial.","OBJECTIVES


Riociguat is approved for pulmonary arterial hypertension and has antiproliferative, anti-inflammatory and antifibrotic effects in animal models of tissue fibrosis. We evaluated the efficacy and safety of riociguat in patients with early diffuse cutaneous systemic sclerosis (dcSSc) at high risk of skin fibrosis progression.
METHODS


In this randomised, double-blind, placebo-controlled, phase IIb trial, adults with dcSSc of <18 months' duration and a modified Rodnan skin score (mRSS) 10-22 units received riociguat 0.5 mg to 2.5 mg orally three times daily (n=60) or placebo (n=61). The primary endpoint was change in mRSS from baseline to week 52.
RESULTS


At week 52, change from baseline in mRSS units was -2.09±5.66 (n=57) with riociguat and -0.77±8.24 (n=52) with placebo (difference of least squares means -2.34 (95% CI -4.99 to 0.30; p=0.08)). In patients with interstitial lung disease, forced vital capacity declined by 2.7% with riociguat and 7.6% with placebo. At week 14, average Raynaud's condition score had improved ≥50% in 19 (41.3%)/46 patients with riociguat and 13 (26.0%)/50 patients with placebo. Safety assessments showed no new signals with riociguat and no treatment-related deaths.
CONCLUSIONS


Riociguat did not significantly benefit mRSS versus placebo at the predefined p<0.05. Secondary and exploratory analyses showed potential efficacy signals that should be tested in further trials. Riociguat was well tolerated.",2020,"At week 14, average Raynaud's condition score had improved ≥50% in 19 (41.3%)/46 patients with riociguat and 13 (26.0%)/50 patients with placebo.","[""adults with dcSSc of <18 months' duration and a modified Rodnan skin score (mRSS) 10-22 units received"", 'n=57) with riociguat and -0.77±8.24', 'patients with early diffuse cutaneous systemic sclerosis (dcSSc) at high risk of skin fibrosis progression', 'patients with early diffuse cutaneous systemic sclerosis (RISE-SSc']","['riociguat', 'riociguat 0.5 mg to 2.5 mg orally three times daily (n=60) or placebo', 'placebo']","['forced vital capacity', ""average Raynaud's condition score"", 'tolerated', 'efficacy and safety', 'change in mRSS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1258104', 'cui_str': 'Progressive systemic sclerosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4728203', 'cui_str': 'Modified Rodnan skin score'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C2717561', 'cui_str': 'riociguat'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0263008', 'cui_str': 'Fibrosis of the skin'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0035853', 'cui_str': 'Rose'}]","[{'cui': 'C2717561', 'cui_str': 'riociguat'}, {'cui': 'C3667592', 'cui_str': 'riociguat 0.5 MG'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0034734', 'cui_str': ""Raynaud's disease""}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4728203', 'cui_str': 'Modified Rodnan skin score'}]",,0.511816,"At week 14, average Raynaud's condition score had improved ≥50% in 19 (41.3%)/46 patients with riociguat and 13 (26.0%)/50 patients with placebo.","[{'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'Division of Rheumatology, University of Michigan, Ann Arbor, Michigan, USA khannad@med.umich.edu oliver.distler@usz.ch.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Allanore', 'Affiliation': 'Rheumatology A department, Cochin Hospital, APHP, Paris Descartes University, Paris, France.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Denton', 'Affiliation': 'Division of Medicine, Centre for Rheumatology, University College London, London, UK.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Kuwana', 'Affiliation': 'Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Matucci-Cerinic', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Firenze, Italy.'}, {'ForeName': 'Janet E', 'Initials': 'JE', 'LastName': 'Pope', 'Affiliation': 'Schulich School of Medicine, Division of Rheumatology, The University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Radim', 'Initials': 'R', 'LastName': 'Bečvář', 'Affiliation': 'Institute of Rheumatology, Department of Rheumatology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'László', 'Initials': 'L', 'LastName': 'Czirják', 'Affiliation': 'Department of Rheumatology and Immunology, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hachulla', 'Affiliation': 'Department of Internal Medicine and Clinical Immunology, Claude Huriez Hospital, Lille University School of Medicine, Lille, France.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Ishii', 'Affiliation': 'Clinical Research, Innovation and Education Center, Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Dermatology, Gunma University Postgraduate School of Medicine, Maebashi, Japan.'}, {'ForeName': 'Sindhu R', 'Initials': 'SR', 'LastName': 'Johnson', 'Affiliation': 'Division of Rheumatology, Department of Medicine, Toronto Western Hospital, University Health Network, Mount Sinai Hospital, University of Toronto, Toronto Scleroderma Research Program, Toronto, Ontario, Canada.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'De Langhe', 'Affiliation': 'Laboratory of Tissue Homeostasis and Disease, Skeletal Biology and Engineering Research Center, Department of Development and Regeneration, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Stagnaro', 'Affiliation': 'Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Riccieri', 'Affiliation': 'Department of Clinical Medicine and Therapy, University of Rome La Sapienza, Rome, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Schiopu', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Michigan Medicine University Hospitals, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'Division of Rheumatology and Immunology, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Smith', 'Affiliation': 'Department of Rheumatology and Internal Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Steen', 'Affiliation': 'Division of Rheumatology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Stevens', 'Affiliation': ""Department of Rheumatology, St. Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Szücs', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'Marie-Elise', 'Initials': 'ME', 'LastName': 'Truchetet', 'Affiliation': 'Department of Rheumatology, CHU Bordeaux, Bordeaux, France.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Wosnitza', 'Affiliation': 'Research & Development, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Kaisa', 'Initials': 'K', 'LastName': 'Laapas', 'Affiliation': 'StatFinn Oy, Espoo, Finland.'}, {'ForeName': 'Janethe', 'Initials': 'J', 'LastName': 'de Oliveira Pena', 'Affiliation': 'Bayer HealthCare Pharmaceuticals Inc, Whippany, New Jersey, USA.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'Bayer Healthcare, Beijing, China.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kramer', 'Affiliation': 'Research & Development, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Distler', 'Affiliation': 'Department of Rheumatology, University Hospital, Zurich, Switzerland khannad@med.umich.edu oliver.distler@usz.ch.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216823']
390,32300013,"Asking young children to ""do science"" instead of ""be scientists"" increases science engagement in a randomized field experiment.","Subtle features of common language can imply to young children that scientists are a special and distinct kind of person-a way of thinking that can interfere with the development of children's own engagement with science. We conducted a large field experiment (involving 45 prekindergarten schools, 130 teachers, and over 1,100 children) to test if targeting subtle properties of language can increase science engagement in children's daily lives. Despite strong tendencies to describe scientists as a special kind of person (in a baseline control condition), brief video-based training changed the language that teachers used to introduce science to their students. These changes in language were powerful enough to predict children's science interest and behavior days later. Thus, subtle features of language shape children's beliefs and behaviors as they unfold in real world environments. Harnessing these mechanisms could promote science engagement in early childhood.",2020,"Despite strong tendencies to describe scientists as a special kind of person (in a baseline control condition), brief video-based training changed the language that teachers used to introduce science to their students.","[""children's daily lives"", '45 prekindergarten schools, 130 teachers, and over 1,100 children']",[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]",[],[],1100.0,0.0458692,"Despite strong tendencies to describe scientists as a special kind of person (in a baseline control condition), brief video-based training changed the language that teachers used to introduce science to their students.","[{'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Rhodes', 'Affiliation': 'Department of Psychology, New York University, New York, NY 10003; marjorie.rhodes@nyu.edu.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Cardarelli', 'Affiliation': 'Department of Psychology, New York University, New York, NY 10003.'}, {'ForeName': 'Sarah-Jane', 'Initials': 'SJ', 'LastName': 'Leslie', 'Affiliation': 'Department of Philosophy, Princeton University, Princeton, NJ 08544.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1919646117']
391,31087060,Estimation of Mortality Risk in Type 2 Diabetic Patients (ENFORCE): An Inexpensive and Parsimonious Prediction Model.,"CONTEXT


We previously developed and validated an inexpensive and parsimonious prediction model of 2-year all-cause mortality in real-life patients with type 2 diabetes.
OBJECTIVE


This model, now named ENFORCE (EstimatioN oF mORtality risk in type 2 diabetiC patiEnts), was investigated in terms of (i) prediction performance at 6 years, a more clinically useful time-horizon; (ii) further validation in an independent sample; and (iii) performance comparison in a real-life vs a clinical trial setting.
DESIGN


Observational prospective randomized clinical trial.
SETTING


White patients with type 2 diabetes.
PATIENTS


Gargano Mortality Study (GMS; n = 1019), Foggia Mortality Study (FMS; n = 1045), and Pisa Mortality Study (PMS; n = 972) as real-life samples and the standard glycemic arm of the ACCORD (Action to Control Cardiovascular Risk in Diabetes) clinical trial (n = 3150).
MAIN OUTCOME MEASURE


The endpoint was all-cause mortality. Prediction accuracy and calibration were estimated to assess the model's performances.
RESULTS


ENFORCE yielded 6-year mortality C-statistics of 0.79, 0.78, and 0.75 in GMS, FMS, and PMS, respectively (P heterogeneity = 0.71). Pooling the three cohorts showed a 6-year mortality C-statistic of 0.80. In the ACCORD trial, ENFORCE achieved a C-statistic of 0.68, a value significantly lower than that obtained in the pooled real-life samples (P < 0.0001). This difference resembles that observed with other models comparing real-life vs clinical trial settings, thus suggesting it is a true, replicable phenomenon.
CONCLUSIONS


The time horizon of ENFORCE has been extended to 6 years and validated in three independent samples. ENFORCE is a free and user-friendly risk calculator of all-cause mortality in white patients with type 2 diabetes from a real-life setting.",2019,"In the ACCORD trial, ENFORCE achieved a C-statistic of 0.68, a value which is significantly lower than that obtained in the pooled real-life samples (P<0.0001).","['White patients with type 2 diabetes', 'real-life type 2 diabetic patients', 'type2 diabetiC patiEnts (ENFORCE']",[],"['cause mortality', 'Foggia Mortality Study (FMS', '6-year mortality C-statistics', 'Pisa Mortality Study (PMS; n=972) as real-life samples and the standard glycemic arm of the ACCORD clinical trial (n=3150']","[{'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]",[],"[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0033046', 'cui_str': 'PMS - Premenstrual syndrome'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]",3150.0,0.0556168,"In the ACCORD trial, ENFORCE achieved a C-statistic of 0.68, a value which is significantly lower than that obtained in the pooled real-life samples (P<0.0001).","[{'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Copetti', 'Affiliation': 'Unit of Biostatistics, Fondazione IRCCS ""Casa Sollievo della Sofferenza"", San Giovanni Rotondo, Italy.'}, {'ForeName': 'Hetal', 'Initials': 'H', 'LastName': 'Shah', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, Massachusetts.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fontana', 'Affiliation': 'Unit of Biostatistics, Fondazione IRCCS ""Casa Sollievo della Sofferenza"", San Giovanni Rotondo, Italy.'}, {'ForeName': 'Maria Giovanna', 'Initials': 'MG', 'LastName': 'Scarale', 'Affiliation': 'Research Unit of Diabetes and Endocrine Diseases, Fondazione IRCCS ""Casa Sollievo della Sofferenza"", San Giovanni Rotondo, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Menzaghi', 'Affiliation': 'Research Unit of Diabetes and Endocrine Diseases, Fondazione IRCCS ""Casa Sollievo della Sofferenza"", San Giovanni Rotondo, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'De Cosmo', 'Affiliation': 'Department of Clinical Sciences, Fondazione IRCCS ""Casa Sollievo Della Sofferenza"", San Giovanni Rotondo, Italy.'}, {'ForeName': 'Monia', 'Initials': 'M', 'LastName': 'Garofolo', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Maria Rosaria', 'Initials': 'MR', 'LastName': 'Sorrentino', 'Affiliation': 'Unit of Endocrinology and Diabetology, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Lamacchia', 'Affiliation': 'Unit of Endocrinology and Diabetology, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Penno', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Doria', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, Massachusetts.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Trischitta', 'Affiliation': 'Research Unit of Diabetes and Endocrine Diseases, Fondazione IRCCS ""Casa Sollievo della Sofferenza"", San Giovanni Rotondo, Italy.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00215']
392,31087455,Efficacy of antepartum administration of hepatitis B immunoglobulin in preventing mother-to-child transmission of hepatitis B virus.,"The aim of this study was to investigate the efficacy of antepartum administration of three doses of hepatitis B immunoglobulin (HBIG) in interrupting mother-to-child transmission (MTCT) of hepatitis B virus (HBV). In this trial, a total of 728 HBeAg-positive pregnant women with chronic HBV infection who had an HBV DNA level higher than 6log 10   copies/mL were enrolled. They were divided into three groups based on individual preference. Subjects in group A and group B received 200 IU (unit) HBIG and 400 IU (unit) HBIG intramuscularly once a month at the third, second and first month before delivery, respectively. Subjects in the control group (C) received no special treatment. All the infants received passive-active immunoprophylaxis. The HBsAg-positive rate of all infants at 7-12 months of age was 5.1% (37/728). Specifically, the HBsAg-positive rate of infants was comparable in all three groups (5.3% vs 5.1% vs 5%, P = 0.988). No significant difference was found in anti-HBs levels between the infants aged 7-12 months in the three groups (P = 0.469). HBV DNA levels of the umbilical cord blood in the HBV-infected group were higher than those in the uninfected group (5.2 vs 3.4log 10   copies/mL, P < 0.001), and these with family history of HBV infection were also higher (45.9% vs 28.5%, P = 0.034). To conclude, administration of passive-active immunoprophylaxis to infants contributed to effective prevention of the MTCT of HBV; extra antepartum administration of HBIG during pregnancy could not decrease the rate of MTCT or increase the anti-HBs levels of infants born to HBsAg-positive mothers with HBV DNA higher than 6log 10   copies/mL.",2019,No significant difference was found in anti-HBs levels between the infants aged 7-12 months in the three groups (P = 0.469).,"['interrupting mother-to-child transmission (MTCT) of hepatitis B virus (HBV', '728 HBeAg-positive pregnant women with chronic HBV infection who had an HBV DNA level higher than 6log 10  \xa0copies/mL were enrolled', 'mother-to-child transmission of hepatitis B virus']","['HBIG and 400\xa0IU (unit) HBIG', 'hepatitis B immunoglobulin', 'hepatitis B immunoglobulin (HBIG', 'passive-active immunoprophylaxis', 'no special treatment', '200\xa0IU (unit']","['family history of HBV infection', 'HBV DNA levels of the umbilical cord blood', 'HBsAg-positive rate', 'rate of MTCT', 'anti-HBs levels']","[{'cui': 'C0443239', 'cui_str': 'Interrupted (qualifier value)'}, {'cui': 'C0282474', 'cui_str': 'Mother-to-Child Transmission'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0019167', 'cui_str': 'e Antigens'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0062525', 'cui_str': 'hepatitis B immunoglobin'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0241889', 'cui_str': 'Family Medical History'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0149709', 'cui_str': 'HBsAg positive'}, {'cui': 'C0369334', 'cui_str': 'Antibody to hepatitis B surface antigen (substance)'}]",,0.030232,No significant difference was found in anti-HBs levels between the infants aged 7-12 months in the three groups (P = 0.469).,"[{'ForeName': 'Mengyu', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Difficult & Complicated Liver Diseases and Artificial Liver Center, Beijing Youan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Huaibin', 'Initials': 'H', 'LastName': 'Zou', 'Affiliation': 'Difficult & Complicated Liver Diseases and Artificial Liver Center, Beijing Youan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Difficult & Complicated Liver Diseases and Artificial Liver Center, Beijing Youan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Sujun', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Difficult & Complicated Liver Diseases and Artificial Liver Center, Beijing Youan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhongping', 'Initials': 'Z', 'LastName': 'Duan', 'Affiliation': 'Difficult & Complicated Liver Diseases and Artificial Liver Center, Beijing Youan Hospital, Capital Medical University, Beijing, China.'}]",Journal of viral hepatitis,['10.1111/jvh.13123']
393,31192505,Identification of infants with increased type 1 diabetes genetic risk for enrollment into Primary Prevention Trials-GPPAD-02 study design and first results.,"Primary prevention of type 1 diabetes (T1D) requires intervention in genetically at-risk infants. The Global Platform for the Prevention of Autoimmune Diabetes (GPPAD) has established a screening program, GPPAD-02, that identifies infants with a genetic high risk of T1D, enrolls these into primary prevention trials, and follows the children for beta-cell autoantibodies and diabetes. Genetic testing is offered either at delivery, together with the regular newborn testing, or at a newborn health care visits before the age of 5 months in regions of Germany (Bavaria, Saxony, Lower Saxony), UK (Oxford), Poland (Warsaw), Belgium (Leuven), and Sweden (Region Skåne). Seven clinical centers will screen around 330 000 infants. Using a genetic score based on 46 T1D susceptibility single-nucleotide polymorphisms (SNPs) or three SNPS and a first-degree family history for T1D, infants with a high (>10%) genetic risk for developing multiple beta-cell autoantibodies by the age of 6 years are identified. Screening from October 2017 to December 2018 was performed in 50 669 infants. The prevalence of high genetic risk for T1D in these infants was 1.1%. Infants with high genetic risk for T1D are followed up and offered to participate in a randomized controlled trial aiming to prevent beta-cell autoimmunity and T1D by tolerance induction with oral insulin. The GPPAD-02 study provides a unique path to primary prevention of beta-cell autoimmunity in the general population. The eventual benefit to the community, if successful, will be a reduction in the number of children developing beta-cell autoimmunity and T1D.",2019,"The Global Platform for the Prevention of Autoimmune Diabetes (GPPAD) has established a screening program, GPPAD-02, that identifies infants with a genetic high risk of T1D, enrolls these into primary prevention trials, and follows the children for beta-cell autoantibodies and diabetes.","['Infants with high genetic risk for T1D', 'genetically at-risk infants', '46 T1D susceptibility single-nucleotide polymorphisms (SNPs) or three SNPS and a first-degree family history for T1D, infants with a high (>10%) genetic risk for developing multiple beta-cell autoantibodies by the age of 6\u2009years', 'Screening from October 2017 to December 2018 was performed in 50\u2009669 infants']",[],[],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0444502', 'cui_str': 'First degree (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0004358', 'cui_str': 'Autoantibodies'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]",[],[],,0.0307783,"The Global Platform for the Prevention of Autoimmune Diabetes (GPPAD) has established a screening program, GPPAD-02, that identifies infants with a genetic high risk of T1D, enrolls these into primary prevention trials, and follows the children for beta-cell autoantibodies and diabetes.","[{'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Winkler', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Munich, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Haupt', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Heigermoser', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Munich, Germany.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Zapardiel-Gonzalo', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Munich, Germany.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Ohli', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Munich, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Faure', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Munich, Germany.'}, {'ForeName': 'Evdokia', 'Initials': 'E', 'LastName': 'Kalideri', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Munich, Germany.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Hommel', 'Affiliation': 'Faculty of Medicine, Center for Regenerative Therapies Dresden (CRTD), Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Petrina', 'Initials': 'P', 'LastName': 'Delivani', 'Affiliation': 'Faculty of Medicine, Center for Regenerative Therapies Dresden (CRTD), Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Berner', 'Affiliation': 'Department of Pediatrics, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Kordonouri', 'Affiliation': 'Hannoversche Kinderheilanstalt, Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Roloff', 'Affiliation': 'Hannoversche Kinderheilanstalt, Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.'}, {'ForeName': 'Thekla', 'Initials': 'T', 'LastName': 'von dem Berge', 'Affiliation': 'Hannoversche Kinderheilanstalt, Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Department of Medical Psychology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Oltarzewski', 'Affiliation': 'Institute of Mother and Child, Warsaw, Poland.'}, {'ForeName': 'Ryszard', 'Initials': 'R', 'LastName': 'Glab', 'Affiliation': 'Institute of Mother and Child, Warsaw, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Szypowska', 'Affiliation': 'Department of Paediatrics, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Snape', 'Affiliation': 'Department of Paediatrics, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Vatish', 'Affiliation': ""Nuffield Department of Women's & Reproductive Health, University of Oxford, Oxford, UK.""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Todd', 'Affiliation': 'Nuffield Department of Medicine, Wellcome Centre for Human Genetics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Helena E', 'Initials': 'HE', 'LastName': 'Larsson', 'Affiliation': 'Unit for Pediatric Endocrinology, Department of Clinical Sciences Malmö, Lund University, Lund, Sweden.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Ramelius', 'Affiliation': 'Lund University, Lund, Sweden.'}, {'ForeName': 'Jeanette Å', 'Initials': 'JÅ', 'LastName': 'Kördel', 'Affiliation': 'Lund University, Lund, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Casteels', 'Affiliation': 'Department of Pediatrics, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Paulus', 'Affiliation': 'Department of Pediatrics, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Anette G', 'Initials': 'AG', 'LastName': 'Ziegler', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Munich, Germany.'}, {'ForeName': 'Ezio', 'Initials': 'E', 'LastName': 'Bonifacio', 'Affiliation': 'Faculty of Medicine, Center for Regenerative Therapies Dresden (CRTD), Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric diabetes,['10.1111/pedi.12870']
394,31197861,Randomised clinical trial: intravenous vs oral iron for the treatment of anaemia after acute gastrointestinal bleeding.,"BACKGROUND


Acute gastrointestinal bleeding is prevalent condition and iron deficiency anaemia is a common comorbidity, yet anaemia treatment guidelines for affected patients are lacking.
AIM


To compare efficacy and safety of intravenous ferric carboxymaltose (FCM) and oral ferrous sulphate (FeSulf) in patients with anaemia secondary to non-variceal gastrointestinal bleeding METHODS: A prospective 42-day study randomised 61 patients with haemoglobin <10 g/dL upon discharge (Day 0) to receive FCM (n = 29; Day 0: 1000 mg, Day 7: 500 or 1000 mg; per label) or FeSulf (n = 32; 325 mg/12 hours for 6 weeks). Outcome measures were assessed on Days 0 (baseline), 7, 21 and 42. The primary outcome was complete response (haemoglobin ≥12 g/dL [women], ≥13 g/dL [men]) after 6 weeks.
RESULTS


A higher proportion of complete response was observed in the FCM vs the FeSulf group at Days 21 (85.7% vs 45.2%; P = 0.001) and 42 (100% vs 61.3%; P < 0.001). Additionally, the percentage of patients with partial response (haemoglobin increment ≥2 g/dL from baseline) was significantly higher in the FCM vs the FeSulf group (Day 21:100% vs 67.7%; P = 0.001, Day 42:100% vs 74.2%; P = 0.003). At Day 42, normalisation of transferrin saturation to 25% or greater was observed in 76.9% of FCM vs 24.1% of FeSulf-treated patients (P < 0.001). No patient in the FCM group reported any adverse event vs 10 patients in the FeSulf group.
CONCLUSION


FCM provided greater and faster Hb increase and iron repletion, and was better tolerated than FeSulf in patients with iron deficiency anaemia secondary to non-variceal acute gastrointestinal bleeding.",2019,"FCM provided greater and faster Hb increase and iron repletion, and was better tolerated than FeSulf in patients with iron deficiency anaemia secondary to non-variceal acute gastrointestinal bleeding.","['61 patients with haemoglobin <10\xa0g/dL upon discharge (Day 0) to receive', 'patients with iron deficiency anaemia secondary to non-variceal acute gastrointestinal bleeding', 'anaemia after acute gastrointestinal bleeding', 'women], ≥13\xa0g/dL [men]) after 6\xa0weeks', 'patients with anaemia secondary to non-variceal gastrointestinal bleeding METHODS']","['FeSulf', 'FCM', 'intravenous ferric carboxymaltose (FCM) and oral ferrous sulphate (FeSulf']","['faster Hb increase and iron repletion', 'complete response (haemoglobin ≥12\xa0g/dL', 'normalisation of transferrin saturation', 'complete response', 'efficacy and safety', 'adverse event', 'partial response (haemoglobin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0266807', 'cui_str': 'Acute gastrointestinal hemorrhage (disorder)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0060282', 'cui_str': 'ferrous sulfate'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation index (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}]",61.0,0.361302,"FCM provided greater and faster Hb increase and iron repletion, and was better tolerated than FeSulf in patients with iron deficiency anaemia secondary to non-variceal acute gastrointestinal bleeding.","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Ferrer-Barceló', 'Affiliation': 'Hospital General Universitario de Valencia, Servicio de Patología Digestiva, Valencia, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Sanchis Artero', 'Affiliation': 'Hospital General Universitario de Valencia, Servicio de Patología Digestiva, Valencia, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sempere García-Argüelles', 'Affiliation': 'Hospital General Universitario de Valencia, Servicio de Patología Digestiva, Valencia, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Canelles Gamir', 'Affiliation': 'Hospital General Universitario de Valencia, Servicio de Patología Digestiva, Valencia, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'P Gisbert', 'Affiliation': 'Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP) y Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.'}, {'ForeName': 'Luis Manuel', 'Initials': 'LM', 'LastName': 'Ferrer-Arranz', 'Affiliation': 'Hospital General Universitario de Valencia, Servicio de Patología Digestiva, Valencia, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Monzó Gallego', 'Affiliation': 'Hospital General Universitario de Valencia, Servicio de Patología Digestiva, Valencia, Spain.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Plana Campos', 'Affiliation': 'Hospital General Universitario de Valencia, Servicio de Patología Digestiva, Valencia, Spain.'}, {'ForeName': 'Jose Mª', 'Initials': 'JM', 'LastName': 'Huguet Malavés', 'Affiliation': 'Hospital General Universitario de Valencia, Servicio de Patología Digestiva, Valencia, Spain.'}, {'ForeName': 'Marisol', 'Initials': 'M', 'LastName': 'Luján Sanchis', 'Affiliation': 'Hospital General Universitario de Valencia, Servicio de Patología Digestiva, Valencia, Spain.'}, {'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'Ruiz Sánchez', 'Affiliation': 'Hospital General Universitario de Valencia, Servicio de Patología Digestiva, Valencia, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Barceló Cerdá', 'Affiliation': 'Departamento de Estadística e Investigación Operativa y Calidad, Universitat Politècnica de València, Valencia, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Medina Chuliá', 'Affiliation': 'Hospital General Universitario de Valencia, Servicio de Patología Digestiva, Valencia, Spain.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15327']
395,31109915,Integrated stepped alcohol treatment for patients with HIV and alcohol use disorder: a randomised controlled trial.,"BACKGROUND


We examined the effectiveness of integrated stepped alcohol treatment (ISAT) on alcohol use and HIV outcomes among patients living with HIV and alcohol use disorder.
METHODS


In this multisite, randomised controlled trial, conducted in five Veterans Affairs-based HIV clinics in the USA (Atlanta, GA; Brooklyn-Manhattan, NY; Dallas and Houston, TX; and Washington, DC), we recruited people living with HIV and an alcohol use disorder who were not otherwise receiving formal alcohol treatment. Patients were eligible if they were aged 18 years or older, HIV positive, English speaking, and met criteria for alcohol use disorder by the Diagnostic and Statistical Manual for Mental Disorders-IV criteria for alcohol abuse or dependence. Key exclusion criteria included if the patient was acutely suicidal or had a psychiatric condition that affected their ability to participate in counselling interventions, or if they had any medical conditions that would preclude completing the study or cause harm during the course of the study. Using a web-based clinical trial management system, we randomly assigned participants (1:1) to receive ISAT or treatment as usual; patients, investigators, and clinicians were unmasked to allocation. ISAT involved three steps: step 1, addiction physician management, comprising eight sessions; step 2, addiction physician management plus motivational enhancement therapy, comprising four sessions; and step 3, specialty referral. Participants were stepped up at weeks 4 and 12 if they exceeded a priori drinking criteria. Treatment as usual involved referral to substance use treatment services. The primary outcome was number of drinks per week over the past 30 days at week 24 by use of the timeline followback method, assessed in the intention-to-treat population. Adverse events were tracked throughout the study period in all randomly assigned participants. This trial is registered at ClinicalTrials.gov, number NCT01410123.
FINDINGS


Between Jan 28, 2013, and July 14, 2017, 128 of 351 patients assessed for eligibility were eligible and randomly assigned to receive ISAT (n=63) or treatment as usual (n=65). Mean age was 54 years (range 23-70), 125 (98%) of 128 participants were men, and 101 (79%) were black. 25 (20%) were lost to follow-up. In the ISAT group, of 57 participants who did not die or withdraw, 30 (52%) advanced to step 2, and 17 (57%) of 30 advanced to step 3. 32 (51%) of 63 participants assigned to ISAT versus 17 (26%) of 65 assigned to treatment as usual received at least one alcohol treatment medication (p=0·004). Participants in both groups decreased their alcohol consumption, but at week 24 we did not detect a difference in number of drinks per week between the groups (least squares mean 10·4 drinks per week [SD 16·5] in the ISAT group vs 15·6 drinks per week [SD 17·6] in the treatment as usual group; adjusted mean difference -4·2, 95% CI -9·4 to 0·9; p=0·11). One adverse event occurred that was possibly related to treatment occurred in the ISAT group (headache).
INTERPRETATION


ISAT increases the receipt of alcohol treatment medications and counselling without changes in drinking at week 24. Strategies to implement and enhance ISAT are needed. Future efforts should focus on promoting ISAT with attention to enhancing patient engagement and retention in alcohol-related care.
FUNDING


US National Institute on Alcohol Abuse and Alcoholism.",2019,"Participants in both groups decreased their alcohol consumption, but at week 24 we did not detect a difference in number of drinks per week between the groups (least squares mean 10·4 drinks per week [SD 16·5] in the ISAT group vs 15·6 drinks per week [SD 17·6] in the treatment as usual group; adjusted mean difference -4·2, 95% CI -9·4 to 0·9; p=0·11).","['patients living with HIV and alcohol use disorder', 'Between Jan 28, 2013, and July 14, 2017', 'Key exclusion criteria included if the patient was acutely suicidal or had a psychiatric condition that affected their ability to participate in counselling interventions, or if they had any medical conditions that would preclude completing the study or cause harm during the course of the study', 'Mean age was 54 years (range 23-70), 125 (98%) of 128 participants were men, and 101 (79%) were black', '57 participants who did not die or withdraw, 30 (52%) advanced to step 2, and 17 (57%) of 30 advanced to step 3', 'patients with HIV and alcohol use disorder', 'five Veterans Affairs-based HIV clinics in the USA (Atlanta, GA; Brooklyn-Manhattan, NY; Dallas and Houston, TX; and Washington, DC), we recruited people living with HIV and an alcohol use disorder who were not otherwise receiving formal alcohol treatment', '128 of 351 patients assessed for eligibility were eligible', 'Patients were eligible if they were aged 18 years or older, HIV positive, English speaking, and met criteria for alcohol use disorder by the Diagnostic and Statistical Manual for Mental Disorders-IV criteria for alcohol abuse or dependence']","['integrated stepped alcohol treatment (ISAT', 'ISAT', 'addiction physician management plus motivational enhancement therapy', 'Integrated stepped alcohol treatment']","['number of drinks', 'number of drinks per week over the past 30 days', 'alcohol consumption', 'Adverse events', 'alcohol use and HIV outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0085762', 'cui_str': 'Alcohol abuse (disorder)'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",128.0,0.136665,"Participants in both groups decreased their alcohol consumption, but at week 24 we did not detect a difference in number of drinks per week between the groups (least squares mean 10·4 drinks per week [SD 16·5] in the ISAT group vs 15·6 drinks per week [SD 17·6] in the treatment as usual group; adjusted mean difference -4·2, 95% CI -9·4 to 0·9; p=0·11).","[{'ForeName': 'E Jennifer', 'Initials': 'EJ', 'LastName': 'Edelman', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT, USA. Electronic address: ejennifer.edelman@yale.edu.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Maisto', 'Affiliation': 'Syracuse University, Syracuse, NY, USA.'}, {'ForeName': 'Nathan B', 'Initials': 'NB', 'LastName': 'Hansen', 'Affiliation': 'Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT, USA; College of Public Health, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Cutter', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA; Yale Center for Analytic Sciences, Yale University School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Yale Center for Analytic Sciences, Yale University School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Lynn E', 'Initials': 'LE', 'LastName': 'Fiellin', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Patrick G', 'Initials': 'PG', 'LastName': ""O'Connor"", 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Bedimo', 'Affiliation': 'Veterans Affairs North Texas Health Care System and UT Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Gibert', 'Affiliation': 'Washington DC Veterans Affairs Medical Center and George Washington University School of Medicine and Health Sciences, Washington, DC, USA.'}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Marconi', 'Affiliation': 'Atlanta Veterans Affairs Medical Center and Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rimland', 'Affiliation': 'Atlanta Veterans Affairs Medical Center and Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Rodriguez-Barradas', 'Affiliation': 'Michael E DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Simberkoff', 'Affiliation': 'Veterans Affairs NY Harbor Healthcare System and New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Janet P', 'Initials': 'JP', 'LastName': 'Tate', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA; Veterans Affairs Connecticut Healthcare System, Veterans Aging Cohort Study, West Haven, CT, USA.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Justice', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT, USA; Veterans Affairs Connecticut Healthcare System, Veterans Aging Cohort Study, West Haven, CT, USA.'}, {'ForeName': 'Kendall J', 'Initials': 'KJ', 'LastName': 'Bryant', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism HIV/AIDS Program, Bethesda, MD, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Fiellin', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(19)30076-1']
396,31173645,"Effects of CYP3A inhibitors on the pharmacokinetics of quizartinib, a potent and selective FLT3 inhibitor, and its active metabolite.","AIMS


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


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


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


These results suggest reducing the dose of quizartinib when coadministered with a strong CYP3A inhibitor, but not with a moderate or weak CYP3A inhibitor. This dose reduction was implemented in phase 3 evaluation of quizartinib.",2019,"Overall, 5.4% of subjects experienced quizartinib-related adverse events (AEs); no serious AEs or deaths occurred.
","['patients with FLT3-internal tandem duplication (ITD)-mutated acute myeloid leukaemia (AML', 'Ninety-three healthy subjects were randomised; 86 completed the study']","['ketoconazole', 'quizartinib+ketoconazole, (2) quizartinib+fluconazole, or (3) quizartinib alone', 'CYP3A inhibitors', 'ketoconazole 200 mg or fluconazole', 'fluconazole']","['quizartinib C max  and AUC inf', 'quizartinib-related adverse events (AEs); no serious AEs or deaths', 'geometric mean ratios']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0332597', 'cui_str': 'Duplication (finding)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0022625', 'cui_str': 'Ketoconazole'}, {'cui': 'C2980091', 'cui_str': 'AC220 compound'}, {'cui': 'C3850056', 'cui_str': 'CYP3A Inhibitors'}, {'cui': 'C0992485', 'cui_str': 'Ketoconazole 200 MG'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}]","[{'cui': 'C2980091', 'cui_str': 'AC220 compound'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",93.0,0.0292452,"Overall, 5.4% of subjects experienced quizartinib-related adverse events (AEs); no serious AEs or deaths occurred.
","[{'ForeName': 'Jianke', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Daiichi Sankyo, Inc, San Diego, CA, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kankam', 'Affiliation': 'Vince & Associates Clinical Research, Overland Park, KS, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Trone', 'Affiliation': 'Daiichi Sankyo, Inc, San Diego, CA, USA.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Gammon', 'Affiliation': 'Daiichi Sankyo, Inc, San Diego, CA, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.14022']
397,31162787,Cornea nerve fibre state determines analgesic response to tapentadol in fibromyalgia patients without effective endogenous pain modulation.,"BACKGROUND


Tapentadol is a centrally acting analgesic with μ-agonistic activity combined with noradrenaline reuptake inhibition. Its mechanism of action relies on improvement of descending pain inhibition. In the current study, tapentadol's ability to enhance conditioned pain modulation (CPM, an experimental measure of descending pain inhibition) was evaluated in fibromyalgia patients with absent or reduced CPM responses.
METHODS


A total of 34 fibromyalgia patients completed this double-blind trial. Patients were randomized to receive treatment with tapentadol sustained-release or placebo for a 3-month period with 1-month follow-up. At baseline, the cornea nerve fibre state (CNFS) was quantified to determine the presence of nerve fibre pathology and assess its value in the prediction of the analgesic response.
RESULTS


Tapentadol significantly increased CPM responses during treatment with an average increase from baseline of 20.5 ± 12.5% (tapentadol) versus 3.0 ± 11.2% (placebo; p = 0.042). No treatment effect was observed for the absolute pain scores, however, analgesia responder rate analyses demonstrated a treatment effect in favour of tapentadol. Pain relief (a reduction in pain score ≥ 30%) was predicted by the presence of a normal CNFS (p = 0.035). Patients with an abnormal CNFS had no analgesic effect from tapentadol despite an increase in CPM.
CONCLUSIONS


In chronic pain patients with fibromyalgia, the increase in endogenous pain inhibition by tapentadol was translated into analgesia in patients with a normal CNFS. In those with abnormal CNFS, tapentadol treatment was without analgesic effect.
SIGNIFICANCE


In this double-blind randomized placebo-controlled trial, we showed that tapentadol significantly enhanced the descending pain inhibition in fibromyalgia patients. Tapentadol-induced pain relief was only present in patients with a normal CNFS.",2019,"No treatment effect was observed for the absolute pain scores, however, analgesia responder rate analyses demonstrated a treatment effect in favour of tapentadol.","['fibromyalgia patients with absent or reduced CPM responses', 'chronic pain patients with fibromyalgia', 'patients with a normal CNFS', 'fibromyalgia patients', 'fibromyalgia patients without effective endogenous pain modulation', '34 fibromyalgia patients']","['Tapentadol', 'tapentadol sustained-release or placebo', 'tapentadol', 'placebo']","['Pain relief', 'pain inhibition', 'CPM', 'analgesic effect', 'CPM responses', 'absolute pain scores', 'cornea nerve fibre state (CNFS', 'endogenous pain inhibition', 'pain relief']","[{'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0392412', 'cui_str': 'cpm'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C2001271', 'cui_str': 'tapentadol'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0392412', 'cui_str': 'cpm'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0010031', 'cui_str': 'Cornea'}, {'cui': 'C0027749', 'cui_str': 'Nerve Fibers'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}]",34.0,0.586201,"No treatment effect was observed for the absolute pain scores, however, analgesia responder rate analyses demonstrated a treatment effect in favour of tapentadol.","[{'ForeName': 'Tine', 'Initials': 'T', 'LastName': 'van de Donk', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'van Velzen', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Dahan', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Niesters', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands.'}]","European journal of pain (London, England)",['10.1002/ejp.1435']
398,32229581,Antidopaminergic treatment is associated with reduced chorea and irritability but impaired cognition in Huntington's disease (Enroll-HD).,"OBJECTIVES


Alterations in dopamine neurotransmission underlie some of the clinical features of Huntington's disease (HD) and as such are a target for therapeutic intervention, especially for the treatment of chorea and some behavioural problems. However, justification for such an intervention is mainly based on case reports and small open label studies and the effects these drugs have on cognition in HD remain unclear.
METHODS


In this study, we used the Enroll-HD observational database to assess the effects of antidopaminergic medication on motor, psychiatric and cognitive decline, over a 3-year period. We first looked at the annual rate of decline of a group of HD patients taking antidopaminergic medication (n=466) compared with an untreated matched group (n=466). The groups were matched on specified clinical variables using propensity score matching. Next, we studied a separate group of HD patients who were prescribed such medications part way through the study (n=90) and compared their rate of change before and after the drugs were introduced and compared this to a matched control group.
RESULTS


We found that HD patients taking antidopaminergic medication had a slower progression in chorea and irritability compared with those not taking such medications. However, this same group of patients also displayed significantly greater rate of decline in a range of cognitive tasks.
CONCLUSION


In conclusion we found that antidopaminergic treatment is associated with improvements in the choreic movements and irritability of HD but worsens cognition. However, further research is required to prospectively investigate this and whether these are causally linked, ideally in a double-blind placebo-controlled trial.",2020,In conclusion we found that antidopaminergic treatment is associated with improvements in the choreic movements and irritability of HD but worsens cognition.,"['HD patients taking antidopaminergic medication (n=466) compared with an untreated matched group (n=466', 'HD patients who were prescribed such medications part way through the study (n=90']","['antidopaminergic medication', 'Antidopaminergic']","['chorea and irritability', 'choreic movements and irritability of HD but worsens cognition', 'motor, psychiatric and cognitive decline']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0008489', 'cui_str': 'Choreatic Syndromes'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}]",,0.0291193,In conclusion we found that antidopaminergic treatment is associated with improvements in the choreic movements and irritability of HD but worsens cognition.,"[{'ForeName': 'Kate L', 'Initials': 'KL', 'LastName': 'Harris', 'Affiliation': 'Department of Clinical Neurosciences, The University of Cambridge, Cambridge, United Kingdom kh600@cam.ac.uk.'}, {'ForeName': 'Wei-Li', 'Initials': 'WL', 'LastName': 'Kuan', 'Affiliation': 'Department of Clinical Neurosciences, The University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Mason', 'Affiliation': 'Department of Clinical Neurosciences, Cambridge Centre for Brain Repair, Cambridge, Cambridgeshire, United Kingdom.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Barker', 'Affiliation': 'Department of Clinical Neurosciences, John van Geest Centre for Brain Repair, and MRC-WT Cambridge Stem Cell Institute, University of Cambridge, Cambridge, United Kingdom.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2019-322038']
399,32239737,"Meralgia paresthetica: Nerve stimulator-guided injection with methylprednisolone/lidocaine, a double-blind randomized placebo-controlled study.","BACKGROUND


Meralgia paresthetica is a mononeuropathy of the lateral femoral cutaneous nerve. A common therapy is injection with corticosteroids. The goal of this study was to analyze the effect of injection with methylprednisolone/lidocaine vs placebo.
METHODS


After randomization, 10 patients received a nerve stimulator-guided injection with methylprednisolone/lidocaine, and 10 patients received saline. The primary outcome measure was pain (visual analogue scale, VAS).
RESULTS


In the placebo group, there was a significant pain reduction (baseline VAS, 6.8; VAS week 12, 4.3; P = .014). The VAS score in the methylprednisolone group did not show a significant reduction (baseline VAS, 7.4; VAS week 12, 4.8; P = .053). There was no significant difference in pain reduction between the groups.
CONCLUSIONS


We found no objective evidence for benefit from nerve stimulator-guided injection with corticosteroids in meralgia paresthetica, although this study is limited by a small sample size. Future placebo-controlled studies using ultrasound-guided injection are warranted.",2020,"We found no objective evidence for benefit from nerve stimulator-guided injection with corticosteroids in meralgia paraesthetica, although this study is limited by a small sample size.",[],"['methylprednisolone', 'placebo', 'methylprednisolone/lidocaine', 'saline', 'nerve stimulator-guided injection with methylprednisolone/lidocaine']","['VAS score', 'pain (visual analogue scale, VAS', 'pain reduction']",[],"[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0582124', 'cui_str': 'Neurostimulator'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.599475,"We found no objective evidence for benefit from nerve stimulator-guided injection with corticosteroids in meralgia paraesthetica, although this study is limited by a small sample size.","[{'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Kloosterziel', 'Affiliation': 'Department of Neurology, Haga Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Dénes L J', 'Initials': 'DLJ', 'LastName': 'Tavy', 'Affiliation': 'Department of Neurology, Haga Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Arends', 'Affiliation': 'Department of Neurology, Haga Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Joyce M', 'Initials': 'JM', 'LastName': 'Zijdewind', 'Affiliation': 'Department of Neurology, Haga Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Erik W', 'Initials': 'EW', 'LastName': 'van Zwet', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Wirtz', 'Affiliation': 'Department of Neurology, Haga Hospital, The Hague, The Netherlands.'}]",Muscle & nerve,['10.1002/mus.26877']
400,32161055,Initial combination therapy of ambrisentan and tadalafil in connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) in the modified intention-to-treat population of the AMBITION study: post hoc analysis.,"OBJECTIVES


To evaluate initial combination therapy with ambrisentan plus tadalafil (COMB) compared with monotherapy of either agent (MONO), and the utility of baseline characteristics and risk stratification in predicting outcomes, in patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) and the systemic sclerosis (SSc)-pulmonary arterial hypertension (PAH) subpopulation.
METHODS


This post hoc analysis of the Ambrisentan and Tadalafil in Patients with Pulmonary Arterial Hypertension (AMBITION) study included patients with CTD-PAH from the modified intention-to-treat population. Time to clinical failure (TtCF) was assessed by baseline characteristics, treatment assignment and risk group (low, intermediate and high) at baseline and week 16. TtCF was compared between groups using Kaplan-Meier curves and Cox proportional hazards regression modelling.
RESULTS


The analysis included 216 patients (COMB, n=117; MONO, n=99). The risk of clinical failure was lower with COMB versus MONO (risk reduction: CTD-PAH 51.7%, SSc-PAH 53.7%), particularly in patients with haemodynamic parameters characteristic of typical PAH without features of left heart disease and/or restrictive lung disease at baseline. The risk of clinical failure was lower with COMB versus MONO in the baseline low-risk group (HR not calculated due to no events in COMB), baseline intermediate-risk group (HR 0.519, 95% CI 0.297 to 0.905) and in the week 16 low-risk group (HR 0.069, 95% CI 0.009 to 0.548).
CONCLUSIONS


The benefit of COMB over MONO was demonstrated in patients with CTD-PAH, particularly in those with typical PAH haemodynamic characteristics at baseline. COMB is appropriate for patients categorised as low risk and intermediate risk at baseline and low risk at follow-up.
TRIAL REGISTRATION NUMBER


NCT01178073.",2020,"The risk of clinical failure was lower with COMB versus MONO (risk reduction: CTD-PAH 51.7%, SSc-PAH 53.7%), particularly in patients with haemodynamic parameters characteristic of typical PAH without features of left heart disease and/or restrictive lung disease at baseline.","['Patients with Pulmonary Arterial Hypertension (AMBITION) study included patients with CTD-PAH from the modified intention-to-treat population', 'connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH', '216 patients (COMB, n=117; MONO, n=99', 'patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) and the systemic sclerosis (SSc)-pulmonary arterial hypertension (PAH) subpopulation']","['ambrisentan plus tadalafil (COMB', 'monotherapy of either agent (MONO', 'ambrisentan and tadalafil', 'TtCF', 'Ambrisentan and Tadalafil']","['risk of clinical failure', 'Time to clinical failure (TtCF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary hypertensive arterial disease (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0009782', 'cui_str': 'Connective Tissue Diseases'}, {'cui': 'C1701938', 'cui_str': 'Associated pulmonary arterial hypertension (disorder)'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C3854046', 'cui_str': 'Comb'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0854255', 'cui_str': 'Systemic sclerosis pulmonary'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C1176329', 'cui_str': 'ambrisentan'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C3854046', 'cui_str': 'Comb'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",216.0,0.134752,"The risk of clinical failure was lower with COMB versus MONO (risk reduction: CTD-PAH 51.7%, SSc-PAH 53.7%), particularly in patients with haemodynamic parameters characteristic of typical PAH without features of left heart disease and/or restrictive lung disease at baseline.","[{'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Kuwana', 'Affiliation': 'Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan kuwanam@nms.ac.jp.'}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Blair', 'Affiliation': 'Research and Development, Gilead Sciences, Inc, Foster City, California, USA.'}, {'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Medical Affairs, GlaxoSmithKline Plc, Tokyo, Japan.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Langley', 'Affiliation': 'Medical Affairs, GlaxoSmithKline Plc, Brentford, London, UK.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Coghlan', 'Affiliation': 'Cardiology Services, Royal Free Hospital, London, UK.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216274']
401,32078168,"The effect of sleep restriction, with or without high-intensity interval exercise, on myofibrillar protein synthesis in healthy young men.","KEY POINTS


Sleep restriction has previously been associated with the loss of muscle mass in both human and animal models. The rate of myofibrillar protein synthesis (MyoPS) is a key variable in regulating skeletal muscle mass and can be increased by performing high-intensity interval exercise (HIIE), although the effect of sleep restriction on MyoPS is unknown. In the present study, we demonstrate that participants undergoing a sleep restriction protocol (five nights, with 4 h in bed each night) had lower rates of skeletal muscle MyoPS; however, rates of MyoPS were maintained at control levels by performing HIIE during this period. Our data suggest that the lower rates of MyoPS in the sleep restriction group may contribute to the detrimental effects of sleep loss on muscle mass and that HIIE may be used as an intervention to counteract these effects.
ABSTRACT


The present study aimed to investigate the effect of sleep restriction, with or without high-intensity interval exercise (HIIE), on the potential mechanisms underpinning previously-reported sleep-loss-induced reductions to muscle mass. Twenty-four healthy, young men underwent a protocol consisting of two nights of controlled baseline sleep and a five-night intervention period. Participants were allocated into one of three parallel groups, matched for age,    V   ̇   O   2     peak        , body mass index and habitual sleep duration; a normal sleep (NS) group [8 h time in bed (TIB) each night], a sleep restriction (SR) group (4 h TIB each night), and a sleep restriction and exercise group (SR+EX, 4 h TIB each night, with three sessions of HIIE). Deuterium oxide was ingested prior to commencing the study and muscle biopsies obtained pre- and post-intervention were used to assess myofibrillar protein synthesis (MyoPS) and molecular markers of protein synthesis and degradation signalling pathways. MyoPS was lower in the SR group [fractional synthetic rate (% day -1  ), mean ± SD, 1.24 ± 0.21] compared to both the NS (1.53 ± 0.09) and SR+EX groups (1.61 ± 0.14) (P < 0.05). However, there were no changes in the purported regulators of protein synthesis (i.e. p-AKT ser473  and p-mTOR ser2448  ) and degradation (i.e. Foxo1/3 mRNA and LC3 protein) in any group. These data suggest that MyoPS is acutely reduced by sleep restriction, although MyoPS can be maintained by performing HIIE. These findings may explain the sleep-loss-induced reductions in muscle mass previously reported and also highlight the potential therapeutic benefit of HIIE to maintain myofibrillar remodelling in this context.",2020,MyoPS was lower in the SR group (FSR %,"['participants undergoing a', 'healthy young men', 'Twenty-four healthy, young men']","['sleep restriction, with or without high-intensity interval exercise (HIIE', 'Deuterium Oxide (D 2  O', 'sleep restriction protocol', 'MyoPS', 'normal sleep group (NS, 8\xa0h time in bed (TIB) each night), a sleep restriction group (SR, 4\xa0h TIB each night), and a sleep restriction and exercise group (SR+EX, 4\xa0h TIB each night, with three sessions of HIIE', 'sleep restriction, with or without high-intensity interval exercise']","['rates of MyoPS', 'rate of myofibrillar protein synthesis (MyoPS', 'MyoPS', 'rates of skeletal muscle MyoPS']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0011745', 'cui_str': 'Heavy Water'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0004916', 'cui_str': 'Beds'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}]",24.0,0.0152582,MyoPS was lower in the SR group (FSR %,"[{'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Saner', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Matthew J-C', 'Initials': 'MJ', 'LastName': 'Lee', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Nathan W', 'Initials': 'NW', 'LastName': 'Pitchford', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Jujiao', 'Initials': 'J', 'LastName': 'Kuang', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Roach', 'Affiliation': 'Appleton Institute for Behavioural Science, Central Queensland University, Adelaide, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Garnham', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Tanner', 'Initials': 'T', 'LastName': 'Stokes', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Phillips', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, Canada.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Bishop', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Bartlett', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}]",The Journal of physiology,['10.1113/JP278828']
402,32223554,The Effects of Dextrose Prolotherapy in Symptomatic Knee Osteoarthritis: A Randomized Controlled Study.,"Objective:  To investigate the effects of dextrose prolotherapy in patients with knee osteoarthritis (KOA).  Design:  A prospective, randomized-controlled interventional trial.  Setting:  An outpatient pain medicine clinic.  Participants:  The study included 66 patients aged 40-70 years with chronic knee pain refractory to conservative therapy and diagnosed as grade II or III KOA according to the Kellgren-Lawrence classification. The patients were assigned to dextrose prolotherapy group (PG;  n  = 22), saline group (SG;  n  = 22), or control group (CG;  n  = 22).  Interventions:  The intra- and extra-articular dextrose prolotherapy and saline injections were administered to the PG and SG, respectively, at 0, 3, and 6 weeks. The patients were blinded to their injection group status. A home-based exercise program was prescribed for all patients in all three groups.  Outcome measures:  The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, activity pain, stiffness severity measured using a visual analog scale (VAS), and the health-related quality of life (HRQoL) scores measured using the Short Form-36 (SF-36) subscales were recorded at the baseline, 6-week, and 18-week follow-ups.  Results:  The WOMAC-pain and VAS-activity pain scores decreased significantly in the PG compared to the SG ( p  = 0.002 and  p  < 0.001, respectively) and CG ( p  < 0.001 and  p  < 0.001, respectively) at 18 weeks. The WOMAC-stiffness scores decreased in the PG compared to the CG at 18 weeks ( p  < 0.001). The WOMAC physical functioning scores were improved in the PG compared to the CG at 18 weeks ( p  < 0.001). The physical component scores of the HRQoL were significantly improved in the PG compared to the CG at 18 weeks ( p  = 0.016), but the mental component scores of the HRQoL showed no significant differences.  Conclusions:  These findings suggest that dextrose prolotherapy is effective at reducing pain and improving the functional status and quality of life in patients with KOA.",2020,The WOMAC-stiffness scores decreased in the PG compared to the CG at 18 weeks ( p  < 0.001).,"['patients with knee osteoarthritis (KOA', '66 patients aged 40-70 years with chronic knee pain refractory to conservative therapy and diagnosed as Grade II or III KOA according to the Kellgren-Lawrence classification', 'Participants', 'Symptomatic Knee Osteoarthritis']","['dextrose prolotherapy', 'saline group (SG;  n \u2009=\u200922), or control group (CG;  n \u2009=\u200922', 'Dextrose Prolotherapy']","['WOMAC physical functioning scores', 'WOMAC-stiffness scores', 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, activity pain, stiffness severity measured using a visual analog scale (VAS), and the health-related quality of life (HRQoL) scores measured using the Short Form-36 (SF-36) subscales', 'pain and improving the functional status and quality of life', 'physical component scores of the HRQoL', 'WOMAC-pain and VAS-activity pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]","[{'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0500223', 'cui_str': 'Proliferation Therapy'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",66.0,0.0595351,The WOMAC-stiffness scores decreased in the PG compared to the CG at 18 weeks ( p  < 0.001).,"[{'ForeName': 'Alketa T', 'Initials': 'AT', 'LastName': 'Sert', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul University Istanbul Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Ekin I', 'Initials': 'EI', 'LastName': 'Sen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul University Istanbul Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Esmaeilzadeh', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul University Istanbul Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Ozcan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul University Istanbul Faculty of Medicine, Istanbul, Turkey.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0335']
403,31771991,Initial Results from Mobile Low-Dose Computerized Tomographic Lung Cancer Screening Unit: Improved Outcomes for Underserved Populations.,"INTRODUCTION


The National Lung Screening Trial (NLST) demonstrated that screening high-risk patients with low-dose computed tomography (CT) of the chest reduces lung cancer mortality compared with screening with chest x-ray. Uninsured and Medicaid patients usually lack access to this hospital-based screening test because of geographic and socioeconomic factors. We hypothesized that a mobile screening unit would improve access and confer the benefits demonstrated by the NLST to this underserved group, which is most at risk of lung cancer deaths.
PATIENTS AND METHODS


We created a mobile unit by building a Samsung BodyTom portable 32-slice low-dose CT scanner into a 35-foot coach; it delivers high-quality images for both soft tissue and bone and includes a waiting area and high-speed wireless internet connection for fast image transfer. The unit was extensively tested to show robustness and stability of mobile equipment. This project was designed to screen uninsured and underinsured patients, otherwise with eligibility criteria identical to that of the National Lung Screening Trial, with the only difference being exclusion of patients eligible for Medicare (which provides financial coverage for CT-based lung cancer screening).
RESULTS


We screened 550 patients (20% black, 3% Hispanic, 70% rural) with a male-to-female ratio of 1.1:1, median age 61 years (range, 55-64), and found 12 lung cancers at initial screen (2.2%), including 6 at stage I-II (58% of total lung cancers early stage) and 38 Lung-RADS 4 (highly suspicious) lesions that are being followed closely. Incidental findings included nonlung cancers and coronary artery disease.
DISCUSSION


In this initial pilot study, using the first mobile low-dose whole body CT screening unit in the U.S., the initial cancer detection rate is comparable to that reported in the NLST, despite excluding patients over the age of 64 years who have Medicare coverage, but with marked improvement of screening rates specifically in underserved sociodemographic, racial, and ethnic groups and with better outcomes than conventionally found in the underserved and at lower cost per case.
IMPLICATIONS FOR PRACTICE


This study shows clearly that a mobile low-dose CT scanning unit allows effective lung cancer screening for underserved populations, such as impoverished African Americans, Hispanics, Native Americans, or isolated rural groups, and has a pick-up rate of 1% for early stage disease. If confirmed in a planned randomized trial, this will be policy changing, as these groups usually present with advanced disease; this approach will produce better survival data at lower cost per case.",2020,"This study shows clearly that a mobile low-dose CT scanning unit allows effective lung cancer screening for underserved populations, such as impoverished African Americans, Hispanics, Native Americans, or isolated rural groups, and has a pick-up rate of 1% for early stage disease.","['550 patients (20% black, 3% Hispanic, 70% rural) with a male-to-female ratio of 1.1:1, median age 61\u2009years (range, 55-64), and found 12 lung cancers at initial screen (2.2%), including 6 at stage I-II (58% of total lung cancers early stage) and 38 Lung-RADS 4 (highly suspicious) lesions that are being followed closely', 'screen uninsured and underinsured patients, otherwise with eligibility criteria identical to that of the National Lung Screening Trial, with the only difference being exclusion of patients eligible for Medicare (which provides financial coverage for CT-based lung cancer screening']","['Mobile Low-Dose Computerized Tomographic Lung Cancer Screening Unit', 'CT scanning unit']",['lung cancer mortality'],"[{'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439175', 'cui_str': '% of total (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087132', 'cui_str': 'Underinsured'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",550.0,0.0516046,"This study shows clearly that a mobile low-dose CT scanning unit allows effective lung cancer screening for underserved populations, such as impoverished African Americans, Hispanics, Native Americans, or isolated rural groups, and has a pick-up rate of 1% for early stage disease.","[{'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Raghavan', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'Mellisa', 'Initials': 'M', 'LastName': 'Wheeler', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'Darcy', 'Initials': 'D', 'LastName': 'Doege', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Doty', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Levy', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'Kia A', 'Initials': 'KA', 'LastName': 'Dungan', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Davis', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Robinson', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Kim', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'Kathryn F', 'Initials': 'KF', 'LastName': 'Mileham', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Oliver', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Carrizosa', 'Affiliation': ''}]",The oncologist,['10.1634/theoncologist.2019-0802']
404,31957143,Randomized Controlled Trial of Adult Therapeutic Coloring for the Management of Significant Anxiety in the Emergency Department.,"BACKGROUND


Anxiety and acute distress are significant concerns in the emergency department (ED). Adult coloring books are often utilized as an effective means of relaxation in waiting rooms and newsstands, but there are no reported randomized trials examining their effectiveness as a treatment for anxiety.
METHODS


We set out to examine the effectiveness of adult coloring books using a randomized placebo-controlled trial at a university-affiliated tertiary ED. Anxiety was measured using a validated self-reporting score, the Hospital Anxiety and Depression Scale (HADS-A), with a range of 0 to 21. Patients with HADS-A ≥ 7 were randomly assigned to either an adult coloring pack (n = 26) or placebo pack (n = 27). The primary outcome measure was the within-patient change in HADS-A scores following 2 hours of exposure.
RESULTS


A convenience sample of 117 patients were screened, and 53 patients were randomized. Characteristics of allocated groups were similar in terms of sex, diagnosis, and ethnicity. A higher proportion of intervention subjects spent ≥1 hour engaged with their activity (46.2% vs. 4.0%, p = 0.01). For the primary outcome measure, the mean within-patient decrease in HADS-A score at 2 hours for intervention subjects was 3.7 (95% confidence interval [CI] = 2.4 to 5.1, p < 0.001) versus a decrease of 0.3 (95% CI = -0.6 to 1.2, p = 0.51) in the placebo group.
CONCLUSIONS


Among ED patients, exposure to adult coloring books resulted in lower self-reported levels of anxiety at 2 hours compared to placebo.",2020,"Among ED patients, exposure to adult coloring books resulted in lower self-reported levels of anxiety at 2 hours compared to placebo.","['controlled trial at a university-affiliated tertiary ED', '117 patients were screened, and 53 patients were randomized', 'Patients with HADS-A ≥ 7']","['placebo', 'adult coloring pack (n\xa0=\xa026) or placebo pack']","['Anxiety', 'mean within-patient decrease in HADS-A score', 'Hospital Anxiety and Depression Scale (HADS-A', 'within-patient change in HADS-A scores', 'lower self-reported levels of anxiety']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}]",117.0,0.520361,"Among ED patients, exposure to adult coloring books resulted in lower self-reported levels of anxiety at 2 hours compared to placebo.","[{'ForeName': 'Naveendran', 'Initials': 'N', 'LastName': 'Rajendran', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Tatum Priyambada', 'Initials': 'TP', 'LastName': 'Mitra', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Shahrestani', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Coggins', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, Australia.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.13838']
405,32303377,"Sphenopalatine ganglion block for the treatment of postdural puncture headache: a randomised, blinded, clinical trial.","BACKGROUND


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


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


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


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


NCT03652714.",2020,"In the local anaesthetic group, 50% required an EBP compared with 45% in the placebo group (P=0.76).
","['adults fulfilling the criteria for EBP', '40 patients with an upright median pain intensity of 74 and 84 mm in the local anaesthetic and placebo groups at baseline, respectively', 'postdural puncture headache']","['Sphenopalatine ganglion block', 'placebo', 'transnasal sphenopalatine ganglion block with local anaesthetic vs saline', 'epidural blood patch (EBP', 'sphenopalatine ganglion block bilaterally with 1 ml of either local anaesthetic (lidocaine 4% and ropivacaine 0.5%) or placebo (saline']","['pain in upright position 30 min post-block, measured on a 0-100 mm VAS', 'median pain intensity in upright position', 'pain', 'EBP', 'pain intensity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0162649', 'cui_str': 'Epidural lumbar injection of blood patch'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0751188', 'cui_str': 'Post dural puncture headache'}]","[{'cui': 'C0394799', 'cui_str': 'Injection of anesthetic agent into sphenopalatine ganglion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0162649', 'cui_str': 'Epidural lumbar injection of blood patch'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0162649', 'cui_str': 'Epidural lumbar injection of blood patch'}]",40.0,0.790752,"In the local anaesthetic group, 50% required an EBP compared with 45% in the placebo group (P=0.76).
","[{'ForeName': 'Mads S', 'Initials': 'MS', 'LastName': 'Jespersen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark; Copenhagen Centre for Translational Research, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark. Electronic address: mads.seit.jespersen@regionh.dk.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Jaeger', 'Affiliation': 'Department of Anaesthesia, Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Ægidius', 'Affiliation': 'Department of Neurology, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Fabritius', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Duch', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Nordsjællands Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Rye', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Afshari', 'Affiliation': 'Department of Anaesthesia, Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Meyhoff', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark; Copenhagen Centre for Translational Research, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.02.025']
406,31276747,Microcavitated (ICDAS 3) carious lesion arrest with resin or glass ionomer sealants in first permanent molars: A randomized controlled trial.,"OBJECTIVES


Although there is some consensus that carious lesions in early stages (non-cavitated) could be treated using sealants, neither the type of materials nor their use in lesions with localized enamel breakdown (microcavitated) has been reported To compare the efficacy of resin or glass ionomer (GI) sealants in arresting microcavitated carious lesions (ICDAS 3) in first permanent molars.
MATERIALS AND METHODS


A double-blinded randomized controlled clinical trial was conducted in 41 healthy 6 to 11-year-old children. At the baseline examination, each subject had at least one carious lesion classified as ICDAS 3 on the first permanent molar. One hundred fifty-one lesions were randomized into: Group 1: resin sealants (76 lesions) and Group 2: GI sealant (75 lesions). Carious lesion progression was assessed clinically and radiographically. Progression and retention failure were the outcomes used for group comparisons at p-value<0.05.
RESULTS


After a two-year follow-up, only one lesion progressed to ICDAS 5, without statistically significant differences between the groups (χ 2 (1) = 0.90, p = 0.53). Radiographically, 100 lesions (98%) were arrested and 2 (2%) showed radiographic progression, without differences between groups (χ 2 (1) = 0.93, p = 0.93). At 2 years, complete retention was observed in 77% of the resin-based and in 83% of the GI sealants, without statistical differences between type of sealant (χ 2 (1) = 0.71, p = 0.48). The multilevel mixed model demonstrated that location and type of sealant did not affect retention rates (χ 2 (1) = 24,98, p < 0.001).
CONCLUSION


Sealing ICDAS 3 carious lesions in permanent molars appears to be effective in arresting lesions after a two-year follow-up. Clinicaltrials.gov: RCTICDAS3/2015.
CLINICAL SIGNIFICANCE


Minimally invasive approaches for carious lesion management have been promoted. Using sealants for the treatment of microcavitated lesions (ICDAS 3) appears predictable in the routine practice, without predilection for resin or glass ionomer materials. In addition to preserving tooth structure, this strategy reduces chair-time, dental fear and costs, and increases coverage to dental care.",2019,"At 2 years, complete retention was observed in 77% of the resin-based and in 83% of the GI sealants, without statistical differences between type of sealant (χ 2 (1) = 0.71, p = 0.48).","['One hundred fifty-one lesions', '41 healthy 6 to 11-year-old children']","['resin or glass ionomer (GI) sealants', 'Resin or Glass Ionomer Sealants', 'resin sealants (76 lesions) and Group 2: GI sealant']","['chair-time, dental fear and costs, and increases coverage to dental care', 'retention rates', 'Carious lesion progression', 'complete retention', 'radiographic progression', 'Progression and retention failure']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0061297', 'cui_str': 'glass ionomer'}, {'cui': 'C1261530', 'cui_str': 'Sealant (substance)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}]","[{'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0085380', 'cui_str': 'Fear, Dental'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0011331', 'cui_str': 'Dental Care'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0011334', 'cui_str': 'Dental Decay'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",151.0,0.154525,"At 2 years, complete retention was observed in 77% of the resin-based and in 83% of the GI sealants, without statistical differences between type of sealant (χ 2 (1) = 0.71, p = 0.48).","[{'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Muñoz-Sandoval', 'Affiliation': 'Cariology Unit, Department of Oral Rehabilitation, University of Talca, Chile.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Gambetta-Tessini', 'Affiliation': 'Cariology Unit, Department of Oral Rehabilitation, University of Talca, Chile.'}, {'ForeName': 'Rodrigo A', 'Initials': 'RA', 'LastName': 'Giacaman', 'Affiliation': 'Cariology Unit, Department of Oral Rehabilitation, University of Talca, Chile. Electronic address: giacaman@utalca.cl.'}]",Journal of dentistry,['10.1016/j.jdent.2019.07.001']
407,31279925,Efficacy of 30% silver diamine fluoride compared to atraumatic restorative treatment on dentine caries arrestment in primary molars of preschool children: A 12-months parallel randomized controlled clinical trial.,"OBJECTIVES


This clinical trial investigated the efficacy of silver diamine fluoride (SDF) in arresting dentine caries in primary molars of preschoolers. Time required for treatment, adverse effects, parental aesthetic perception, anxiety and oral health related to quality of life (OHRQoL) was evaluated.
MATERIALS AND METHODS


Children, 2-5 years old, with active dentine caries lesions on the occlusal surface of primary molars were randomly allocated to test group (SDF) or control group (atraumatic restorative treatment/ART). The dmf-t/DMF-T and ICDAS indexes determined the presence of caries and activity. The main outcome after 3, 6 and 12-month follow-up was assessed by a blind examiner. The time required to perform the treatments was recorded and a facial image scale was applied to assess anxiety before and after treatment. Adverse events and aesthetic perception were assessed through questions addressed to caregivers; and the OHRQoL through the B-ECOHIS questionnaire.
RESULTS


In 68 patients that were randomized, the mean number of treated teeth per child was 2.42(1.04) and 2.09(1.18) in the SDF and ART groups (p = 0.074), respectively. The mean difference of arrested lesions between the groups after 12 months was -0,07(0.05; - 0.17-0.30). The time required to treat with SDF was lower than the ART (p < 0.001). There was no difference in the percentage of adverse events + aesthetic perception (p = 0.709), and the change in anxiety (p = 0.155). There was a less impact in OHRQoL after ART treatment, but only when the parents' distress subscale was considered (p = 0.012).
CONCLUSION


SDF requires much less chair-time and have similar results as ART in arresting caries lesion, anxiety, adverse effects, aesthetic perception and quality of life.",2019,"SDF requires much less chair-time and have similar results as ART in arresting caries lesion, anxiety, adverse effects, aesthetic perception and quality of life.","['Children, 2-5 years old, with active dentine caries lesions on the occlusal surface of primary molars', 'primary molars of preschool children', '68 patients', 'primary molars of preschoolers']","['atraumatic restorative treatment', 'silver diamine fluoride (SDF', '30% silver diamine fluoride', 'test group (SDF) or control group (atraumatic restorative treatment/ART']","['Time required for treatment, adverse effects, parental aesthetic perception, anxiety and oral health related to quality of life (OHRQoL', 'distress subscale', 'caries lesion, anxiety, adverse effects, aesthetic perception and quality of life', 'percentage of adverse events\u2009+\u2009aesthetic perception', 'time required to treat with SDF', 'change in anxiety', 'Adverse events and aesthetic perception', 'mean difference of arrested lesions', 'OHRQoL']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0266846', 'cui_str': 'Dental caries extending into dentin'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0074538', 'cui_str': 'silver diamine fluoride'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0029162'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237477', 'cui_str': 'Arrested (qualifier value)'}]",68.0,0.0612485,"SDF requires much less chair-time and have similar results as ART in arresting caries lesion, anxiety, adverse effects, aesthetic perception and quality of life.","[{'ForeName': 'Ana Lúcia', 'Initials': 'AL', 'LastName': 'Vollú', 'Affiliation': 'Department of Pediatric Dentistry and Orthodontics, School of Dentistry, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brazil. Electronic address: avollu@terra.com.br.'}, {'ForeName': 'Gabriella Fernandes', 'Initials': 'GF', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Pediatric Dentistry and Orthodontics, School of Dentistry, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brazil. Electronic address: gabi_rodrigues_@live.com.'}, {'ForeName': 'Roberta Virgílio', 'Initials': 'RV', 'LastName': 'Rougemount Teixeira', 'Affiliation': 'Department of Pediatric Dentistry and Orthodontics, School of Dentistry, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brazil. Electronic address: robertarougemont@hotmail.com.'}, {'ForeName': 'Lais Rueda', 'Initials': 'LR', 'LastName': 'Cruz', 'Affiliation': 'Department of Preventive and Community Dentistry, School of Dentistry, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brazil. Electronic address: lais.rueda@gmail.com.'}, {'ForeName': 'Graziela', 'Initials': 'G', 'LastName': 'Dos Santos Massa', 'Affiliation': 'Department of Preventive and Community Dentistry, School of Dentistry, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brazil. Electronic address: graziela.smassa@gmail.com.'}, {'ForeName': 'Jessica Pronestino', 'Initials': 'JP', 'LastName': 'de Lima Moreira', 'Affiliation': 'Institute of Public Health Studies, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brazil. Electronic address: jessica@iesc.ufrj.br.'}, {'ForeName': 'Ronir Raggio', 'Initials': 'RR', 'LastName': 'Luiz', 'Affiliation': 'Institute of Public Health Studies, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brazil. Electronic address: ronir@iesc.ufrj.br.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Barja-Fidalgo', 'Affiliation': 'Department of Pediatric Dentistry and Orthodontics, School of Dentistry, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brazil; Department of Preventive and Community Dentistry, School of Dentistry, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brazil. Electronic address: fernanda.barja@odonto.ufrj.br.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fonseca-Gonçalves', 'Affiliation': 'Department of Pediatric Dentistry and Orthodontics, School of Dentistry, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brazil. Electronic address: andrea.goncalves@odonto.ufrj.br.'}]",Journal of dentistry,['10.1016/j.jdent.2019.07.003']
408,31325466,Effects of restoring SDF-treated and untreated dentine caries lesions on parental satisfaction and oral health related quality of life of preschool children.,"OBJECTIVES


To find out the effects of placement of atraumatic restorative treatment (ART) restorations on parental satisfaction and oral health related quality of life (OHRQoL) of preschool children with SDF-treated or untreated dentine caries lesions.
METHODS


In a randomized controlled trial conducted in Hong Kong, preschool children who had cavitated dentine caries lesions were randomly assigned to receive application of silver diamine fluoride (SDF) solution or placebo (tonic water) on their caries lesions 10 weeks before receiving ART restorations. Parents were asked to rate their satisfaction with their child's teeth using a 5-point scale (5 = very satisfied, 1 = very dissatisfied) before and six months after the restorative treatment. Besides, the Chinese version of Early Childhood Oral Health Impact Scale (C-ECOHIS) was used to assess the children's OHRQoL.
RESULTS


A total of 194 children participated in this study, with 101 and 93 children receiving SDF and placebo application before ART restorations, respectively. There was no significant difference in parental satisfaction and C-ECOHIS score between the SDF and placebo groups at baseline. At the 6-month follow-up, the mean parental satisfaction score regarding their child's dental health status increased significantly (p < 0.001) from 2.2 ± 0.7 to 2.8 ± 1.0 in the SDF group and from 2.3 ± 0.8 to 2.7 ± 0.9 in the placebo group. However, no significant changes (p > 0.05) in C-ECOHIS scores were found in either of the two groups after ART restoration placement.
CONCLUSIONS


Placement of ART restorations can improve parental satisfaction with the health and appearance of their child's teeth but has no significant effect on the OHRQoL.
CLINICAL SIGNIFICANCE


This study provides valuable information about the effects of ART restoration placement on SDF-treated or untreated dentine caries lesions regarding parental satisfaction and OHRQoL of preschool children.",2019,"However, no significant changes (p > 0.05) in C-ECOHIS scores were found in either of the two groups after ART restoration placement.
","['194 children participated in this study, with 101 and 93 children receiving SDF and placebo application before ART restorations, respectively', 'preschool children', 'preschool children with SDF-treated or untreated dentine caries lesions', 'Hong Kong, preschool children who had cavitated dentine caries lesions']","['OHRQoL', 'placebo', 'restoring SDF-treated and untreated dentine caries lesions', 'atraumatic restorative treatment', 'silver diamine fluoride (SDF) solution or placebo (tonic water']","['parental satisfaction and oral health related quality of life ', ""mean parental satisfaction score regarding their child's dental health status"", 'parental satisfaction and C-ECOHIS score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0266846', 'cui_str': 'Dental caries extending into dentin'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0266846', 'cui_str': 'Dental caries extending into dentin'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0074538', 'cui_str': 'silver diamine fluoride'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0452449', 'cui_str': 'Tonic water (substance)'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0029162'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}]",194.0,0.21082,"However, no significant changes (p > 0.05) in C-ECOHIS scores were found in either of the two groups after ART restoration placement.
","[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'May Chun Mei', 'Initials': 'MCM', 'LastName': 'Wong', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Chun Hung', 'Initials': 'CH', 'LastName': 'Chu', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Linlu', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Edward Chin Man', 'Initials': 'ECM', 'LastName': 'Lo', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China. Electronic address: edward-lo@hku.hk.'}]",Journal of dentistry,['10.1016/j.jdent.2019.07.009']
409,31218738,Appropriateness of prescription of oral anticoagulant therapy in acutely hospitalized older people with atrial fibrillation. Secondary analysis of the SIM-AF cluster randomized clinical trial.,"AIMS


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


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


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


A high proportion of hospitalized older patients with AF remains inappropriately prescribed or nonprescribed with OACs. The management of these patients at hospital admission is the strongest predictor of prescription appropriateness at discharge.",2019,"The prescription of OACs at admission was the strongest predictor of appropriateness at discharge (OR= 7.43, 95% CI= 4.04 - 13.73).
","['acutely hospitalized elderly patients', '51 patients inappropriately prescribed, 82% showed errors on dosage, being mainly under-dosed (N=29, 56.9%), and among 41 inappropriately not prescribed, 98% were taking an antiplatelet drug', '246 patients', 'hospitalized elderly patients with Atrial Fibrillation', 'hospitalized older patients with AF remains inappropriately prescribed or non prescribed with OACs', 'acutely hospitalized older people with atrial fibrillation']","['oral anticoagulant therapy', 'educational intervention improved OAC prescription', 'SIM-AF (SIM ulation-based technologies']","['aspartate aminotransferase, history of falls, alcohol consumption) and antiplatelet prescription at admission']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0085826', 'cui_str': 'Antiplatelet Agents'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy (procedure)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]",246.0,0.12033,"The prescription of OACs at admission was the strongest predictor of appropriateness at discharge (OR= 7.43, 95% CI= 4.04 - 13.73).
","[{'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Antoniazzi', 'Affiliation': ""Scientific Direction, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Ardoino', 'Affiliation': 'Department of Neuroscience, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Proietti', 'Affiliation': 'Department of Neuroscience, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Valter', 'Initials': 'V', 'LastName': 'Monzani', 'Affiliation': ""Department of Internal Medicine, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Pier Mannuccio', 'Initials': 'PM', 'LastName': 'Mannucci', 'Affiliation': ""Scientific Direction, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Nobili', 'Affiliation': 'Department of Neuroscience, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Franchi', 'Affiliation': 'Department of Neuroscience, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of clinical pharmacology,['10.1111/bcp.14029']
410,31215676,Reduced bioavailability of oral amoxicillin tablets compared to suspensions in Roux-en-Y gastric bypass bariatric subjects.,"AIMS


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


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


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


The tablets presented a lower bioavailability than the suspension formulation and the total absorbed amount of AMX in these subjects was lower in comparison to the standard AMX absorption rates in nonbariatric subjects, regardless of the formulation.",2019,"The tablets presented a lower bioavailability than the suspension formulation and the total absorbed amount of AMX in these subjects was lower in comparison to the standard AMX absorption rates in non-bariatric subjects, regardless of the formulation.","['Roux-en-Y gastric bypass (RYGB) bariatric subjects', 'RYGB subjects at least 3 months previously operated was performed', 'RYGB bariatric subjects', 'Twenty subjects aged 42.65 ± 7.21 years old and with a body mass index (BMI) of 29.88 ± 4.36 kg/m 2  were enrolled in the study']","['AMX', 'AMX suspension', 'amoxicillin (AMX) tablets', 'amoxicillin tablets']","['AMX levels', 'bioavailability of the AMX', 'Blood samples', 'Reduced bioavailability', 'standard AMX absorption rates']","[{'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}]",20.0,0.0341686,"The tablets presented a lower bioavailability than the suspension formulation and the total absorbed amount of AMX in these subjects was lower in comparison to the standard AMX absorption rates in non-bariatric subjects, regardless of the formulation.","[{'ForeName': 'Maiara Camotti', 'Initials': 'MC', 'LastName': 'Montanha', 'Affiliation': 'Postgraduate Program in Biosciences and Physiopathology (PBF), Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Thiago Ferreira', 'Initials': 'TF', 'LastName': 'Dos Santos Magon', 'Affiliation': 'Postgraduate Program in Food Science (PPC), Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Conrado', 'Initials': 'C', 'LastName': 'de Souza Alcantara', 'Affiliation': 'Postgraduate Program in Biosciences and Physiopathology (PBF), Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Caroline Ferraz', 'Initials': 'CF', 'LastName': 'Simões', 'Affiliation': 'Postgraduate Program in Physical Education, Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Sandra Regina Bin', 'Initials': 'SRB', 'LastName': 'Silva', 'Affiliation': 'Clinical Research Centre and Bioequivalence Studies, Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Cristina Megumi', 'Initials': 'CM', 'LastName': 'Kuroda', 'Affiliation': 'Clinical Research Centre and Bioequivalence Studies, Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Sérgio Seiji', 'Initials': 'SS', 'LastName': 'Yamada', 'Affiliation': 'Clinical Research Centre and Bioequivalence Studies, Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Lucas Eduardo Savóia', 'Initials': 'LES', 'LastName': 'de Oliveira', 'Affiliation': 'Clinical Research Centre and Bioequivalence Studies, Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Daoud', 'Initials': 'D', 'LastName': 'Nasser', 'Affiliation': 'Clinical Research Centre and Bioequivalence Studies, Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Nelson Nardo', 'Initials': 'NN', 'LastName': 'Junior', 'Affiliation': 'Department of Physical Education, Centre for Multiprofessional Studies of Obesity (NEMO), Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Josmar', 'Initials': 'J', 'LastName': 'Mazucheli', 'Affiliation': 'Department of Statistics, Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Diniz', 'Affiliation': 'Department of Pharmacy, Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Paulo Jorge Pereira Alves', 'Initials': 'PJPA', 'LastName': 'Paixão', 'Affiliation': 'Department of Pharmacy, Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Elza', 'Initials': 'E', 'LastName': 'Kimura', 'Affiliation': 'Postgraduate Program in Biosciences and Physiopathology (PBF), Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}]",British journal of clinical pharmacology,['10.1111/bcp.14023']
411,31238081,"Effects of soy and bovine milk beverages on enamel mineral content in a randomized, double-blind in situ clinical study.","Soy beverages are promoted as healthy alternatives to bovine milk even though they can contain added sugar.
OBJECTIVES


To compare enamel mineral content after consumption of bovine milk or a soy beverage in a double-blind, randomized, cross-over in situ clinical study.
MATERIALS AND METHODS


Human enamel slabs with subsurface lesions were prepared and inserted into intra-oral appliances worn by volunteers who consumed 200 ml of either bovine milk or a soy beverage over a 60 s period once a day for 15 days. Enamel lesion depth and mineral content were measured using transverse microradiography. Saliva samples were collected immediately after consuming the beverages and calcium, inorganic phosphate and fluoride levels analysed. Data were statistically analysed using a linear mixed model.
RESULTS


Depth of the enamel subsurface lesions increased by 7.1 ± 2.0 μm and mineral content decreased by 47 ± 22 vol% min.μm after consumption of the soy beverage indicating demineralization. However, after consumption of bovine milk the depth of the lesions decreased by 7.6 ± 3.5 μm and mineral content increased by 202 ± 43 vol% min.μm indicating remineralization. The changes were significantly different (p < 0.001) between the two beverages. Fluoride levels were similar in the saliva samples for both beverages, however the calcium and inorganic phosphate levels for the bovine milk group were significantly higher (p < 0.02) than those for the soy beverage group.
CONCLUSIONS


In this randomized, double-blind in situ clinical trial consumption of a soy beverage demineralized enamel whereas bovine milk produced remineralization.
CLINICAL SIGNIFICANCE


Although soy beverages are promoted as healthy alternatives to bovine milk the added sugar and low calcium bioavailability of the soy drink makes frequent consumption a caries risk. (Trial registration no. ISRCTN19137849).",2019,"Fluoride levels were similar in the saliva samples for both beverages, however the calcium and inorganic phosphate levels for the bovine milk group were significantly higher (p < 0.02) than those for the soy beverage group.
",['Human enamel slabs with subsurface lesions'],"['oral appliances worn by volunteers who consumed 200\u202fml of either bovine milk or a soy beverage', 'soy and bovine milk beverages', 'bovine milk or a soy beverage']","['Fluoride levels', 'enamel subsurface lesions', 'enamel mineral content', 'calcium and inorganic phosphate levels', 'Enamel lesion depth and mineral content']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0243112'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0452741', 'cui_str': 'Soy Milk'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}]","[{'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0523827', 'cui_str': 'Phosphate, inorganic measurement (procedure)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}]",,0.176697,"Fluoride levels were similar in the saliva samples for both beverages, however the calcium and inorganic phosphate levels for the bovine milk group were significantly higher (p < 0.02) than those for the soy beverage group.
","[{'ForeName': 'Peiyan', 'Initials': 'P', 'LastName': 'Shen', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Glenn D', 'Initials': 'GD', 'LastName': 'Walker', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'Reynolds', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Stanton', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Fernando', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Reynolds', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia. Electronic address: e.reynolds@unimelb.edu.au.'}]",Journal of dentistry,['10.1016/j.jdent.2019.06.007']
412,31240722,Effects of non-dispensing pharmacists integrated in general practice on medication-related hospitalisations.,"AIMS


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


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


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


In general practices with an integrated NDP, the rate of medication-related hospitalisations is lower compared to usual care. No differences with usual care plus were found.",2019,"In general practices with an integrated NDP, the rate of medication-related hospitalisations is lower compared to usual care.","['2013 versus June 2014 to May 2015) in 25 general practices in the Netherlands, comparing', 'patients at high risk of medication problems (being 65 years or older and using five or more chronic medications']","['NDP-led care (intervention) with two current pharmaceutical care models (usual care and usual care plus', 'non-dispensing pharmacists (NDPs', 'pre-post comparison']","['drug burden index or costs', 'rate ratio of medication-related hospitalisations']","[{'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1449618', 'cui_str': 'Pharmaceutical Care'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0285744', 'cui_str': 'NDPS'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",11281.0,0.0895108,"In general practices with an integrated NDP, the rate of medication-related hospitalisations is lower compared to usual care.","[{'ForeName': 'V M', 'Initials': 'VM', 'LastName': 'Sloeserwij', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'A C M', 'Initials': 'ACM', 'LastName': 'Hazen', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'D L M', 'Initials': 'DLM', 'LastName': 'Zwart', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Leendertse', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Poldervaart', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'de Bont', 'Affiliation': 'Erasmus School of Health Policy and Management, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'de Gier', 'Affiliation': 'Department of Pharmacotherapy, Epidemiology and Economics, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Bouvy', 'Affiliation': 'Department of Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'de Wit', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht University, Utrecht, The Netherlands.'}]",British journal of clinical pharmacology,['10.1111/bcp.14041']
413,32193187,"GO-DACT: a phase 3b randomised, double-blind, placebo-controlled trial of GOlimumab plus methotrexate (MTX) versus placebo plus MTX in improving DACTylitis in MTX-naive patients with psoriatic arthritis.","OBJECTIVES


To assess the efficacy of golimumab in combination with methotrexate (MTX) versus MTX monotherapy in psoriatic arthritis (PsA) dactylitis.
METHODS


Multicentre, investigator-initiated, randomised, double-blind, placebo-controlled, parallel-design phase 3b trial in 11 Portuguese rheumatology centres. Patients with PsA along with active dactylitis and naive to MTX and biologic disease-modifying antirheumatic drugs (bDMARDs) were randomly assigned to golimumab or placebo, both in combination with MTX. The primary endpoint was Dactylitis Severity Score (DSS) change from baseline to week 24. Key secondary endpoints included DSS and Leeds Dactylitis Index (LDI) response, and changes from baseline in the LDI and MRI dactylitis score. Analysis was by intention-to-treat for the primary endpoint.
RESULTS


Twenty-one patients received golimumab plus MTX and 23 MTX monotherapy for 24 weeks. One patient from each arm discontinued. Patient inclusion was halted at 50% planned recruitment due to a favourable interim analysis. Median baseline DSS was 6 in both arms. By week 24, patients treated with golimumab plus MTX exhibited significantly greater improvements in DSS relative to MTX monotherapy (median change of 5 vs 2 points, respectively; p=0.026). In the golimumab plus MTX arm, significantly higher proportions of patients achieved at least 50% or 70% improvement in DSS and 20%, 50% or 70% improvement in LDI in comparison to MTX monotherapy.
CONCLUSIONS


The combination of golimumab and MTX as first-line bDMARD therapy is superior to MTX monotherapy for the treatment of PsA dactylitis.
TRIAL REGISTRATION NUMBER


NCT02065713.",2020,"In the golimumab plus MTX arm, significantly higher proportions of patients achieved at least 50% or 70% improvement in DSS and 20%, 50% or 70% improvement in LDI in comparison to MTX monotherapy.
","['MTX-naive patients with psoriatic arthritis', 'Patients with PsA along with active dactylitis and naive to MTX and biologic disease-modifying antirheumatic drugs (bDMARDs', '11 Portuguese rheumatology centres']","['golimumab or placebo, both in combination with MTX', 'placebo plus MTX', 'GOlimumab plus methotrexate (MTX', 'MTX monotherapy', 'golimumab', 'golimumab and MTX', 'placebo', 'golimumab plus MTX', 'methotrexate (MTX', 'GO-DACT']","['DSS and Leeds Dactylitis Index (LDI) response, and changes from baseline in the LDI and MRI dactylitis score', 'Median baseline DSS', 'Dactylitis Severity Score (DSS) change', 'DSS', 'DSS relative to MTX monotherapy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0239161', 'cui_str': 'Dactylitis (disorder)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C0032730', 'cui_str': 'Portuguese (ethnic group)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C2353893', 'cui_str': 'golimumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0239161', 'cui_str': 'Dactylitis (disorder)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}]",11.0,0.76298,"In the golimumab plus MTX arm, significantly higher proportions of patients achieved at least 50% or 70% improvement in DSS and 20%, 50% or 70% improvement in LDI in comparison to MTX monotherapy.
","[{'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Vieira-Sousa', 'Affiliation': 'Rheumatology Research Unit, Instituto de Medicina Molecular, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal elsa-sousa@hotmail.com.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Alves', 'Affiliation': 'Radiology Department, Centro Hospitalar de Lisboa Central EPE, Lisboa, Portugal.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Rodrigues', 'Affiliation': 'Rheumatology Unit, Hospital de Santo Espirito da Ilha Terceira EPER, Angra do Heroismo, Ilha Terceira, Portugal.'}, {'ForeName': 'Filipa', 'Initials': 'F', 'LastName': 'Teixeira', 'Affiliation': 'Rheumatology Department, Unidade Local de Saúde do Alto Minho EPE, Ponte de Lima, Portugal.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Tavares-Costa', 'Affiliation': 'Rheumatology Department, Unidade Local de Saúde do Alto Minho EPE, Ponte de Lima, Portugal.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Bernardo', 'Affiliation': 'Rheumatology Department, Centro Hospitalar Universitário de São João, Porto, Portugal.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Pimenta', 'Affiliation': 'Rheumatology Department, Centro Hospitalar Universitário de São João, Porto, Portugal.'}, {'ForeName': 'Fernando M', 'Initials': 'FM', 'LastName': 'Pimentel-Santos', 'Affiliation': 'Rheumatology Department, Hospital de Egas Moniz, Lisboa, Portugal.'}, {'ForeName': 'João Lagoas', 'Initials': 'JL', 'LastName': 'Gomes', 'Affiliation': 'Rheumatology Department, Hospital de Egas Moniz, Lisboa, Portugal.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Aguiar', 'Affiliation': 'Rheumatology Department, Hospital Infante Dom Pedro, Aveiro, Portugal.'}, {'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Pinto', 'Affiliation': 'Rheumatology Department, Hospital Centre of Vila Nova de Gaia Espinho, Vila Nova de Gaia, Porto, Portugal.'}, {'ForeName': 'Taciana', 'Initials': 'T', 'LastName': 'Videira', 'Affiliation': 'Rheumatology Department, Hospital Centre of Vila Nova de Gaia Espinho, Vila Nova de Gaia, Porto, Portugal.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Catita', 'Affiliation': 'Rheumatology Clinic, Hospital Particular do Algarve, Faro, Portugal.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Santos', 'Affiliation': 'Rheumatology Department, Instituto Português de Reumatologia, Lisboa, Portugal.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Borges', 'Affiliation': 'Rheumatology Department, Instituto Português de Reumatologia, Lisboa, Portugal.'}, {'ForeName': 'Graça', 'Initials': 'G', 'LastName': 'Sequeira', 'Affiliation': 'Rheumatology Department, Centro Hospitalar Universitário do Algarve EPE, Faro, Portugal.'}, {'ForeName': 'Célia', 'Initials': 'C', 'LastName': 'Ribeiro', 'Affiliation': 'Rheumatology Department, Centro Hospitalar Universitário do Algarve EPE, Faro, Portugal.'}, {'ForeName': 'Lídia', 'Initials': 'L', 'LastName': 'Teixeira', 'Affiliation': 'Rheumatology Department, Hospital Garcia de Orta EPE, Almada, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Ávila-Ribeiro', 'Affiliation': 'Rheumatology Research Unit, Instituto de Medicina Molecular, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'Fernando M', 'Initials': 'FM', 'LastName': 'Martins', 'Affiliation': 'Portuguese Society of Rheumatology, Lisboa, Portugal.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Canhão', 'Affiliation': 'Comprehensive Health Research Center (CHRC), Lisbon, Portugal.'}, {'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Ruy M', 'Initials': 'RM', 'LastName': 'Ribeiro', 'Affiliation': 'Laboratório de Biomatemática, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'João Eurico', 'Initials': 'JE', 'LastName': 'Fonseca', 'Affiliation': 'Rheumatology Research Unit, Instituto de Medicina Molecular, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216500']
414,31141837,"Relationship between early-life nutrition and ages at menarche and first pregnancy, and childbirth rates of young adults: Evidence from APCAPS in India.","India's Integrated Child Development Services (ICDS) provides daily supplementary nutrition and other public health services to women and children. We estimated associations between exposure to early-childhood ICDS nutrition and adult reproductive outcomes. During 1987-1990, a balanced protein-calorie supplement called ""upma""-made from locally available corn-soya ingredients-was rolled out by subdistricts near Hyderabad and offered to pregnant women and children under age 6 years. In a controlled trial, 15 villages received the supplement and 14 did not. We used data from a 2010-2012 resurvey of adults born during the trial (n = 715 in intervention and n = 645 in control arms). We used propensity score matching methods to estimate the associations between birth in an intervention village and menarcheal age, age at first pregnancy, and fertility of adults. We found that women born in the intervention group during the trial, as compared with the control group, had menarche 0.45 (95% confidence interval [CI: 0.22, 0.68]; p < .001) years later and first pregnancy 0.53 (95% CI [0.04, 1.02]; p < .05) years later. Married women from the intervention group had menarche 0.36 (95% CI [0.09, 0.64]; p < .01) years later, first cohabitation with partner 0.8 (95% CI [0.27, 1.33]; p < .01) years later, and first pregnancy 0.53 (95% CI [0.04, 1.02]; p < .05) years later than married women in the control group. There was no significant difference between intervention and control group women regarding whether they had at least one childbirth or the total number of children born. The findings were similar when we employed inverse propensity score weighted regression models.",2020,There was no significant difference between intervention and control group women regarding whether they had at least one childbirth or the total number of children born.,"['pregnant women and children under age 6\xa0years', 'women and children', 'young adults', 'Married women from the intervention group had menarche 0.36', '2010-2012 resurvey of adults born during the trial (n\xa0=\xa0715 in intervention and n\xa0=\xa0645 in control arms']","[""India's Integrated Child Development Services (ICDS"", 'balanced protein-calorie supplement called ""upma""-made from locally available corn-soya ingredients-was rolled out by subdistricts near Hyderabad']",[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0025274', 'cui_str': 'Menarche'}, {'cui': 'C4517452', 'cui_str': '0.36'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0087179', 'cui_str': 'Zea'}, {'cui': 'C0037733', 'cui_str': 'Soy Beans'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}]",[],,0.133344,There was no significant difference between intervention and control group women regarding whether they had at least one childbirth or the total number of children born.,"[{'ForeName': 'Arindam', 'Initials': 'A', 'LastName': 'Nandi', 'Affiliation': 'Center for Disease Dynamics, Economics & Policy, Washington, DC, Washington, District of Columbia.'}, {'ForeName': 'Jere R', 'Initials': 'JR', 'LastName': 'Behrman', 'Affiliation': 'Departments of Economics and Sociology, Population Studies Center, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Black', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Kinra', 'Affiliation': 'Department of Non-Communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Ramanan', 'Initials': 'R', 'LastName': 'Laxminarayan', 'Affiliation': 'Center for Disease Dynamics, Economics & Policy, New Delhi, New Delhi, India.'}]",Maternal & child nutrition,['10.1111/mcn.12854']
415,32166877,Effect of adding azithromycin to the antimalarials used for seasonal malaria chemoprevention on the nutritional status of African children.,"OBJECTIVES


Mass administration of azithromycin has reduced mortality in children in sub-Saharan Africa but its mode of action is not well characterised. A recent trial found that azithromycin given alongside seasonal malaria chemoprevention was not associated with a reduction in mortality or hospital admissions in young children. We investigated the effect of azithromycin on the nutritional status of children enrolled in this study.
METHODS


A total of 19 578 children in Burkina Faso and Mali were randomised to receive either azithromycin or placebo alongside seasonal malaria chemoprevention with sulfadoxine-pyrimethamine plus amodiaquine monthly for three malaria transmission seasons (2014-2016). After each transmission season, anthropometric measurements were collected from approximately 4000 randomly selected children (2000 per country) at a cross-sectional survey and used to derive nutritional status indicators. Binary and continuous outcomes between treatment arms were compared by Poisson and linear regression.
RESULTS


Nutritional status among children was poor in both countries with evidence of acute and chronic malnutrition (24.9-33.3% stunted, 15.8-32.0% underweight, 7.2-26.4% wasted). There was a suggestion of improvement in nutritional status in Burkina Faso and deterioration in Mali over the study period. At the end of each malaria transmission season, nutritional status of children did not differ between treatment arms (seasonal malaria chemoprevention plus azithromycin or placebo) in either the intention-to-treat or per-protocol analyses (only children with at least three cycles of SMC in the current intervention year).
CONCLUSIONS


The addition of azithromycin to seasonal malaria chemoprevention did not result in an improvement of nutritional outcomes in children in Burkina Faso and Mali.",2020,The addition of azithromycin to seasonal malaria chemoprevention did not result in an improvement of nutritional outcomes in children in Burkina Faso and Mali.,"['African Children', '19,578 children in Burkina Faso and Mali', 'children in Burkina Faso and Mali', 'young children', 'children enrolled in this study']","['azithromycin', 'Azithromycin', 'azithromycin or placebo', 'sulfadoxine-pyrimethamine plus amodiaquine']","['nutritional outcomes', 'acute and chronic malnutrition', 'mortality or hospital admissions']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}, {'cui': 'C0024581', 'cui_str': 'Republic of Mali'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0700599', 'cui_str': 'Pyrimethamine / Sulfadoxine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}]",19578.0,0.0562404,The addition of azithromycin to seasonal malaria chemoprevention did not result in an improvement of nutritional outcomes in children in Burkina Faso and Mali.,"[{'ForeName': 'Georgia R', 'Initials': 'GR', 'LastName': 'Gore-Langton', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cairns', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Yves Daniel', 'Initials': 'YD', 'LastName': 'Compaoré', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Sagara', 'Affiliation': 'Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Kuepfer', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Zongo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Mariken M', 'Initials': 'MM', 'LastName': 'de Wit', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Amadou', 'Initials': 'A', 'LastName': 'Barry', 'Affiliation': 'Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Modibo', 'Initials': 'M', 'LastName': 'Diarra', 'Affiliation': 'Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Amadou', 'Initials': 'A', 'LastName': 'Tapily', 'Affiliation': 'Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Samba', 'Initials': 'S', 'LastName': 'Coumare', 'Affiliation': 'Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Thera', 'Affiliation': 'Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Nikiema', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'R Serge', 'Initials': 'RS', 'LastName': 'Yerbanga', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Rosemonde M', 'Initials': 'RM', 'LastName': 'Guissou', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Halidou', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Alassane', 'Initials': 'A', 'LastName': 'Dicko', 'Affiliation': 'Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Chandramohan', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Greenwood', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Jean Bosco', 'Initials': 'JB', 'LastName': 'Ouedraogo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13390']
416,31077432,Randomized study of individualized pharmacokinetically-guided dosing of paclitaxel compared with body-surface area dosing in Chinese patients with advanced non-small cell lung cancer.,"AIMS


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


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


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


PK-guided PTX dosing significantly reduced grade 4 haematological toxicities and grade ≥ 2 neuropathy without an adverse impact on clinical outcomes.",2019,"Progression-free survival was slightly improved in PK arm (4.67 vs 4.17 months, P = .026).
","['Chinese patients with advanced non-small cell lung cancer', 'Chinese non-small cell lung cancer patients', '319 stage IIIB/IV non-small cell lung cancer patients receiving first-line chemotherapy were enrolled']","['chemotherapy', 'carboplatin plus PTX', 'pharmacokinetically (PK)-guided paclitaxel (PTX', 'PK-guided PTX', 'individualized pharmacokinetically-guided dosing of paclitaxel', 'BSA', 'body-surface area (BSA)-based dosing']","['2 neuropathy', 'Progression-free survival', 'Objective response rate', 'grade 4 neutropenia', 'average PTX doses and exposure', 'neuropathy, objective response rate, progression-free survival and overall survival', 'grade 4 haematological toxicities and grade', 'cumulative incidence of grade 4 haematological toxicity', 'toxicity and efficacy', 'grade 4 haematological toxicity', 'overall survival']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",319.0,0.2541,"Progression-free survival was slightly improved in PK arm (4.67 vs 4.17 months, P = .026).
","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Huiwei', 'Initials': 'H', 'LastName': 'Qi', 'Affiliation': 'Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Ni', 'Affiliation': 'Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Caicun', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yunying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Saladax Biomedical, Inc., Bethlehem, PA, USA.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Baburina', 'Affiliation': 'Saladax Biomedical, Inc., Bethlehem, PA, USA.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Courtney', 'Affiliation': 'Saladax Biomedical, Inc., Bethlehem, PA, USA.'}, {'ForeName': 'Salvatore J', 'Initials': 'SJ', 'LastName': 'Salamone', 'Affiliation': 'Saladax Biomedical, Inc., Bethlehem, PA, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.13982']
417,31320177,The association of serum interleukin-6 levels with clinical outcomes in antineutrophil cytoplasmic antibody-associated vasculitis.,"OBJECTIVE


To investigate serum IL-6 (sIL-6) levels during active disease, complete remission (CR), and relapse in antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), and to explore the association of changes in sIL-6 with clinical outcomes.
METHODS


sIL-6 levels were measured at baseline and longitudinally over 18 months, in 78 patients with AAV enrolled in a randomized controlled trial comparing treatment with either rituximab (RTX) or cyclophosphamide (CYC)/azathioprine (AZA). Outcome variables included baseline clinical features, ANCA specificity, disease activity (active disease versus CR), time to relapse events, B cell repopulation, and ANCA titer increases.
RESULTS


At baseline, sIL6 levels were detectable in 81% of patients; 73% (n = 57) of subjects were proteinase 3 (PR3)-ANCA positive, sIL-6 levels were higher in subjects with PR3-ANCAs and positively correlated with their levels (r s  = 0.36,p < 0.01), but not with levels of myeloperoxidase (MPO)-ANCA (r s  = -0.17,p = 0.47). Higher baseline sIL-6 levels were associated with PR3-ANCA positivity, fever, pulmonary nodules/cavities, conductive deafness, and absence of urinary red blood cell casts (p < 0.05). Baseline sIL6 levels did not predict CR at month 6 (p = 0.71), and the median sIL-6 level declined from baseline with induction therapy, regardless of CR achievement. An increase in sIL-6 during CR was a predictor for subsequent severe relapse in RTX-treated patients (hazard ratio (HR):7.24,p = 0.01), but not in CYC/AZA-treated patients (HR:0.62,p = 0.50). In contrast, a sIL-6 increase did not predict B cell repopulation or ANCA titer increase in either treatment arm (p > 0.05).
CONCLUSION


At baseline, sIL-6 concentrations correlate with PR3-ANCA titers and are associated with specific clinical manifestations of AAV. Baseline sIL6 concentrations do not predict CR at 6 months, but the increase in sIL-6 concentrations during CR is associated with subsequent severe relapse among RTX-treated patients. Further investigation into the mechanistic role of IL6 in AAV might lead to identifying this pathway as a potential therapeutic target in this disease.",2019,"(PR3)-ANCA positive, sIL-6 levels were higher in subjects with PR3-ANCAs and positively correlated with their levels (r s  = 0.36,p < 0.01), but not with levels of myeloperoxidase (MPO)-ANCA (r s  = -0.17,p = 0.47).",['78 patients with AAV enrolled'],['rituximab (RTX) or cyclophosphamide (CYC)/azathioprine (AZA'],"['PR3-ANCA positivity, fever, pulmonary nodules/cavities, conductive deafness, and absence of urinary red blood cell casts', 'baseline clinical features, ANCA specificity, disease activity (active disease versus CR), time to relapse events, B cell repopulation, and ANCA titer increases', 'sIL-6 increase did not predict B cell repopulation or ANCA titer increase', 'sIL6 levels', 'Baseline sIL6 concentrations', 'sIL-6', 'serum IL-6', 'Higher baseline sIL-6 levels', 'sIL-6 concentrations', 'Baseline sIL6 levels', 'sIL-6) levels during active disease, complete remission (CR), and relapse in antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV', 'median sIL-6 level', 'PR3)-ANCA positive, sIL-6 levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0201530', 'cui_str': 'Antineutrophil cytoplasmic antibody measurement (procedure)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0028259', 'cui_str': 'Nodule (morphologic abnormality)'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}, {'cui': 'C0018777', 'cui_str': 'Conductive hearing loss (disorder)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0333873', 'cui_str': 'Squamous intraepithelial lesion'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2609436', 'cui_str': 'Vasculitis (SMQ)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0238874', 'cui_str': 'Antineutrophil cytoplasmic antibody positive (finding)'}]",78.0,0.149311,"(PR3)-ANCA positive, sIL-6 levels were higher in subjects with PR3-ANCAs and positively correlated with their levels (r s  = 0.36,p < 0.01), but not with levels of myeloperoxidase (MPO)-ANCA (r s  = -0.17,p = 0.47).","[{'ForeName': 'Alvise', 'Initials': 'A', 'LastName': 'Berti', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Roscoe', 'Initials': 'R', 'LastName': 'Warner', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Johnson', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Divi', 'Initials': 'D', 'LastName': 'Cornec', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Darrell R', 'Initials': 'DR', 'LastName': 'Schroeder', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Brian F', 'Initials': 'BF', 'LastName': 'Kabat', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Langford', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Cees G M', 'Initials': 'CGM', 'LastName': 'Kallenberg', 'Affiliation': 'University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Seo', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Spiera', 'Affiliation': 'Hospital for Special Surgery, New York, NY, USA.'}, {'ForeName': 'E William', 'Initials': 'EW', 'LastName': 'St Clair', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Fernando C', 'Initials': 'FC', 'LastName': 'Fervenza', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Stone', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Monach', 'Affiliation': 'Boston University and VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Specks', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA. Electronic address: specks.ulrich@mayo.edu.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Merkel', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of autoimmunity,['10.1016/j.jaut.2019.07.001']
418,31996367,Pragmatic randomised controlled trial of very early etanercept and MTX versus MTX with delayed etanercept in RA: the VEDERA trial.,"OBJECTIVES


We sought to confirm in very early rheumatoid arthritis (ERA) a much greater superiority (30%) of first-line etanercept+methotrexate (ETN+MTX) over treat-to-target MTX (MTX-TT) than previously reported in ERA (14%); and explore whether ETN following initial MTX secures a comparable response to first-line ETN+MTX.
METHODS


Pragmatic, open-label, randomised controlled trial of treatment-naïve ERA (≤12 months symptom), Disease Activity Score 28 joint (DAS28)-erythrocyte sedimentation rate (ESR) ≥3.2, rheumatoid factor (RF)+/-anticitrullinated peptide antibody (ACPA) positive or ultrasound power Doppler (PD) if RF and ACPA negative. Subjects were randomised 1:1 to ETN+MTX; or MTX-TT, escalated to ETN if week 24 DAS28-ESR ≥2.6 and intramuscular corticosteroid at protocolised time points. Primary endpoint of week 48 DAS28ESR remission with clinical and imaging secondary endpoints.
RESULTS


We randomised 120 patients, 60 to each arm (71% female, 73% RF/84% ACPA positive, median (IQR) symptom duration 20.3 (13.1, 30.8) weeks; mean (SD) DAS28 5.1 (1.1)). Remission rates with ETN+MTX and MTX-TT, respectively, were 38% vs 33% at week 24; 52% vs 38% at week 48 (ORs 1.6, 95% CI 0.8 to 3.5, p=0.211). Greater, sustained DAS28-ESR remission observed with ETN+MTX versus MTX-TT (42% and 27%, respectively; p=0.035). PD was fully suppressed by week 48 in over 90% in each arm. Planned exploratory analysis revealed OR 2.84, 95% CI 0.8 to 9.6) of achieving remission after 24 weeks of ETN administered first line compared with administered post-MTX.
CONCLUSIONS


Compared with remission rates typically reported with first-line tumour necrosis factor inhabitor+MTX versus MTX-TT, we did not demonstrate a larger effect in very ERA. Neither strategy conferred remission in the majority of patients although ultrasound confirmed local inflammation suppression. Poorer ETN response following failure of MTX-TT is also suggested.  Trial registration number  NCT02433184.",2020,"Planned exploratory analysis revealed OR 2.84, 95% CI 0.8 to 9.6) of achieving remission after 24 weeks of ETN administered first line compared with administered post-MTX.
",['RA'],"['etanercept+methotrexate (ETN+MTX', 'ETN+MTX', 'MTX (MTX-TT', 'etanercept and MTX versus MTX', 'ETN+MTX; or MTX-TT']","['PD', 'Disease Activity Score 28 joint (DAS28)-erythrocyte sedimentation rate (ESR) ≥3.2, rheumatoid factor (RF)+/-anticitrullinated peptide antibody (ACPA) positive or ultrasound power Doppler (PD) if RF and ACPA negative', 'Remission rates', '48 DAS28ESR remission with clinical and imaging secondary endpoints', 'sustained DAS28-ESR remission']",[],"[{'cui': 'C0717758', 'cui_str': 'Etanercept'}]","[{'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0201660', 'cui_str': 'Rheumatoid factor measurement (procedure)'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C0741132', 'cui_str': 'Antibody test positive'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}]",120.0,0.253962,"Planned exploratory analysis revealed OR 2.84, 95% CI 0.8 to 9.6) of achieving remission after 24 weeks of ETN administered first line compared with administered post-MTX.
","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Horton', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Raluca Bianca', 'Initials': 'RB', 'LastName': 'Dumitru', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Naraghi', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Wakefield', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Elizabeth M A', 'Initials': 'EMA', 'LastName': 'Hensor', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Maya H', 'Initials': 'MH', 'LastName': 'Buch', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK maya.buch@manchester.ac.uk.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216539']
419,31710994,Individual differences in human opioid abuse potential as observed in a human laboratory study.,"BACKGROUND


Opioids have high abuse potential and pose a major public health concern. Yet, a large percentage of individuals exposed to opioids do not develop problematic use. Individual differences in opioid abuse potential are not well understood.
METHODS


This within-subject (N = 16), double-blind, double-dummy, human laboratory study evaluated individual differences in response to dose (placebo, low, medium, high) following administration of heroin and hydromorphone through intravenous and subcutaneous routes, in opioid-experienced but non physically-dependent participants. Outcomes were self-reported visual analog scale (VAS) ratings (High, Liking, Drug Effect, Good Effect, Rush), pupil diameter change from baseline, and crossover point on the Drug vs. Money questionnaire. The degree to which results were consistent across measures within an individual was assessed using a mixed-effects model from which an intraclass correlation coefficient measure of between and within-subject variance was derived.
RESULTS


The mixed effects model fit was significant (p < 0.0001) and revealed that 85.5% of the explainable variance was due to between-subject effects, suggesting the responses within an individual were highly consistent. Visual inspection reveals a myriad response pattern across participants, with some demonstrating classic dose-effect responses and others not differentiating any active doses from placebo.
CONCLUSIONS


Data suggest the abuse potential of opioids is significantly different between individuals but that the experience within an individual is highly consistent. Research to prospectively characterize and evaluate mechanisms underlying these differences is warranted and may provide a foundation to help identify persons at heightened risk of transitioning from opioid exposure to misuse and/or opioid use disorder.",2019,"The mixed effects model fit was significant (p < 0.0001) and revealed that 85.5% of the explainable variance was due to between-subject effects, suggesting the responses within an individual were highly consistent.",[],['heroin and hydromorphone'],"['self-reported visual analog scale (VAS) ratings (High, Liking, Drug Effect, Good Effect, Rush), pupil diameter change from baseline, and crossover point on the Drug vs. Money questionnaire']",[],"[{'cui': 'C0011892', 'cui_str': 'diamorphine'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0728867', 'cui_str': 'Drug action (finding)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0443052', 'cui_str': 'Rush (qualifier value)'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.212725,"The mixed effects model fit was significant (p < 0.0001) and revealed that 85.5% of the explainable variance was due to between-subject effects, suggesting the responses within an individual were highly consistent.","[{'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Dunn', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, United States. Electronic address: kdunn9@jhmi.edu.'}, {'ForeName': 'Frederick S', 'Initials': 'FS', 'LastName': 'Barrett', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, United States.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Brands', 'Affiliation': 'Health Canada, Canada; Centre for Addiction and Mental Health, Canada; University of Toronto, Canada.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Marsh', 'Affiliation': 'Northern Ontario School of Medicine, Canada.'}, {'ForeName': 'George E', 'Initials': 'GE', 'LastName': 'Bigelow', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107688']
420,31981043,Endoscopic Argon Plasma Coagulation vs. Multidisciplinary Evaluation in the Management of Weight Regain After Gastric Bypass Surgery: a Randomized Controlled Trial with SHAM Group.,"BACKGROUND


Roux-en-Y gastric bypass is one of the most widely performed bariatric surgeries. However, the relapse of obesity occurs in approximately 20% of patients and enlargement of the anastomosis is one of the factors associated with this relapse. Endoscopic treatment of the anastomosis has been proposed to assist in renewed weight loss. One endoscopic technique is the narrowing of the anastomosis argon plasma coagulation (APC).
OBJECTIVE


Evaluate the effectiveness and safety of the endoscopic treatment of an enlarged anastomosis with APC.
METHODS


A randomized controlled study was conducted comparing APC to exclusive multidisciplinary management after weight regain.
RESULTS


Forty-two patients were divided into two groups: APC (n = 22) and control (n = 20). After 14 months of follow-up with a crossover at 6 months, significant improvement in satiety and greater weight loss were found in the APC group and after crossover. APC was associated with significant weight loss [9.73 (7.46, 12) vs. + 1.38 (- 1.39, 2.15)], a reduction in the anastomosis diameter [p < 0.001], early satiation [0.77 (0.44, 1.11) vs. - 0.59 (- 0.95, - 0.23), p < 0.001], and increased quality of life measured using the EQ5D index [p = 0.04] and EQ5D VAS scale [p = 0.04]. Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02 kg in the APC and 11.52 kg in the control).
CONCLUSION


Treatment of the gastrojejunal anastomosis with APC was effective and safe, with significant weight loss, the return of early satiation, and an improvement in quality of life.",2020,"Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02 kg in the APC and 11.52 kg in the control).
","['After Gastric Bypass Surgery', 'Forty-two patients']","['Endoscopic Argon Plasma Coagulation vs. Multidisciplinary Evaluation', 'APC', 'SHAM']","['quality of life', 'satiety and greater weight loss', 'weight loss', 'EQ5D VAS scale', 'effectiveness and safety', 'total mean weight loss', 'weight loss, the return of early satiation', 'relapse of obesity occurs', 'Weight Regain']","[{'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1879736', 'cui_str': 'Argon Beam Coagulation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0034380'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0222045'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",42.0,0.0503247,"Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02 kg in the APC and 11.52 kg in the control).
","[{'ForeName': 'Luiz Gustavo', 'Initials': 'LG', 'LastName': 'de Quadros', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil. Gustavo_quadros@hotmail.com.'}, {'ForeName': 'Manoel Galvão', 'Initials': 'MG', 'LastName': 'Neto', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'João Caetano', 'Initials': 'JC', 'LastName': 'Marchesini', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Teixeira', 'Affiliation': 'Orlando Health Hospital, Orlando, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Grecco', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Roberto Luiz Kaiser', 'Initials': 'RLK', 'LastName': 'Junior', 'Affiliation': 'Beneficência Portuguesa Hospital, Sao Jose do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Natan', 'Initials': 'N', 'LastName': 'Zundel', 'Affiliation': 'Jackson North Medical Center, University at Buffalo, Miami, USA.'}, {'ForeName': 'Idiberto José Zotarelli', 'Initials': 'IJZ', 'LastName': 'Filho', 'Affiliation': 'Kaiser Day Hospital, Sao Jose do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Thiago Ferreira', 'Initials': 'TF', 'LastName': 'de Souza', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina, Universidade de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Admar Concon', 'Initials': 'AC', 'LastName': 'Filho', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Lyz Bezerra', 'Initials': 'LB', 'LastName': 'da Silva', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Almino Cardoso', 'Initials': 'AC', 'LastName': 'Ramos', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Álvaro Antônio Bandeira', 'Initials': 'ÁAB', 'LastName': 'Ferraz', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Josemberg Marins', 'Initials': 'JM', 'LastName': 'Campos', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}]",Obesity surgery,['10.1007/s11695-020-04414-6']
421,31942688,Weight Loss and Vomiting 1 Year After Banded Versus Non-banded One Anastomosis Gastric Bypass: a Prospective Randomized Trial.,"BACKGROUND


The weight loss outcomes after banded one-anastomosis gastric bypass (OAGB) remain to be determined.
OBJECTIVE


To compare weight loss and vomiting 1 year after banded versus non-banded OAGB.
METHODS


This is a prospective, open-label, randomized study, which evaluated 33 individuals with morbid obesity, which underwent banded (16 individuals) and non-banded OAGB (17 individuals) and were followed up for 12 months. Weight loss (percentages of total weight loss-%TWL-and excess weight loss-%EWL) and occurrence of vomiting were assessed and compared before surgery and after 6 and 12 months.
RESULTS


At baseline, there were no differences between groups in regard to age, gender, and body mass index (BMI). At 6 and 12 months post-op, and the overall mean %TWL regardless of band use was 22.4 ± 7% and 29 ± 6.9%, respectively, and the overall average %EWL regardless of band use was 66.8 ± 22.9% and 86.3 ± 24%, respectively. %TWL did not differ between the banded and non-banded groups at 6 (21.8 ± 6.8% vs. 23.1 ± 7.4%; p = 0.7) and 12 months post-op (27.5 ± 6.6% vs. 30.4 ± 7.1%; p = 0.3), as well as %EWL at 6 (67 ± 22.9% vs. 67.6 ± 23.6%; p = 0.6) and 12 months post-op (83.5 ± 24.4% vs. 89 ± 24.1%; p = 0.4). The occurrence of vomiting did not significantly differ between banded and non-banded OAGB at 6 (12.5% vs. 11.8%; p = 0.9) and 12 months post-op (12.5% vs. 5.9%; p = 0.5).
CONCLUSION


OAGB led to an overall satisfactory weight loss after 1 year, regardless of band use. Banded OAGB did not lead to neither significantly higher weight loss nor more vomiting than non-banded OAGB 1 year after surgery.",2020,Banded OAGB did not lead to neither significantly higher weight loss nor more vomiting than non-banded OAGB 1 year after surgery.,"['33 individuals with morbid obesity, which underwent banded (16 individuals) and non-banded OAGB (17 individuals) and were followed up for 12\xa0months']","['OAGB', 'Banded Versus Non-banded One Anastomosis Gastric Bypass']","['weight loss and vomiting 1\xa0year', 'overall satisfactory weight loss', 'weight loss nor more vomiting', 'Weight Loss and Vomiting 1 Year', 'occurrence of vomiting', 'Weight loss (percentages of total weight', 'loss-%TWL-and excess weight loss-%EWL) and occurrence of vomiting']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0042965', 'cui_str': 'Vomitus (substance)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",,0.0252491,Banded OAGB did not lead to neither significantly higher weight loss nor more vomiting than non-banded OAGB 1 year after surgery.,"[{'ForeName': 'Everton', 'Initials': 'E', 'LastName': 'Cazzo', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil. notrevezzo@yahoo.com.'}, {'ForeName': 'Laísa Simakawa', 'Initials': 'LS', 'LastName': 'Jimenez', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Felipe Gilberto', 'Initials': 'FG', 'LastName': 'Valerini', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Tiago Bezerra', 'Initials': 'TB', 'LastName': 'de Freitas Diniz', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Almino Cardoso', 'Initials': 'AC', 'LastName': 'Ramos', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Elinton Adami', 'Initials': 'EA', 'LastName': 'Chaim', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}]",Obesity surgery,['10.1007/s11695-020-04393-8']
422,31712614,Study protocol of a double-blind randomised placebo-controlled trial on the effect of a multispecies probiotic on the incidence of antibiotic-associated diarrhoea in persons with spinal cord injury.,"STUDY DESIGN


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


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


Three Dutch SCI rehabilitation centres.
METHODS


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


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


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


The Dutch Trial Register- NTR 5831.",2020,"The difference between the incidence of antibiotic-associated diarrhoea between people with SCI using probiotics compared to those using a placebo at the moment the antibiotics stops, the probiotics stops and two weeks thereafter.
","['persons with spinal cord injury', 'Fifty-six people aged 18-75 years with SCI during inpatient rehabilitation, who require antibiotics, will be given probiotics or placebo randomly assigned (T0', 'Three Dutch SCI rehabilitation centres', 'people with\xa0spinal cord injury (SCI']","['placebo', 'multispecies probiotic', 'probiotics/placebo']","['degree of nausea and information on quality of life', 'incidence of antibiotic-associated diarrhoea', 'Bristol Stool Scale, and bowel management', 'time to reach effective bowel management, degree of nausea and quality of life']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0034380'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0578159', 'cui_str': 'Antibiotic-associated diarrhea (disorder)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0222045'}, {'cui': 'C0150155', 'cui_str': 'Bowel management'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",56.0,0.712196,"The difference between the incidence of antibiotic-associated diarrhoea between people with SCI using probiotics compared to those using a placebo at the moment the antibiotics stops, the probiotics stops and two weeks thereafter.
","[{'ForeName': 'W X M', 'Initials': 'WXM', 'LastName': 'Faber', 'Affiliation': 'Heliomare Rehabilitation Center, Wijk aan Zee, The Netherlands. w.faber@heliomare.nl.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nachtegaal', 'Affiliation': 'Department of Research & Development, Heliomare Rehabilitation Center, Wijk aan Zee, The Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Stolwijk-Swuste', 'Affiliation': 'Center of Excellence for Rehabilitation Medicine, Brain Center Rudolf Magnus, University Medical Center Utrecht and De Hoogstraat Rehabilitation, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Achterberg-Warmer', 'Affiliation': 'Amsterdam Rehabilitation Research Center, Reade, the Netherlands.'}, {'ForeName': 'C J M', 'Initials': 'CJM', 'LastName': 'Koning', 'Affiliation': 'Winclove Probiotics B.V, Amsterdam, The Netherlands.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Besseling-van der Vaart', 'Affiliation': 'Winclove Probiotics B.V, Amsterdam, The Netherlands.'}, {'ForeName': 'C A M', 'Initials': 'CAM', 'LastName': 'van Bennekom', 'Affiliation': 'Heliomare Rehabilitation Center, Wijk aan Zee, The Netherlands.'}]",Spinal cord,['10.1038/s41393-019-0369-y']
423,32098758,"Intra-articular sprifermin reduces cartilage loss in addition to increasing cartilage gain independent of location in the femorotibial joint: post-hoc analysis of a randomised, placebo-controlled phase II clinical trial.","OBJECTIVES


In the phase II FGF-18 Osteoarthritis Randomized Trial with Administration of Repeated Doses (FORWARD) study, sprifermin demonstrated cartilage modification in the total femorotibial joint and in both femorotibial compartments by MRI in patients with knee osteoarthritis. Here, we evaluate whether sprifermin reduces cartilage loss and increases cartilage thickness, independent of location.
METHODS


Patients were randomised 1:1:1:1:1 to three once-weekly intra-articular injections of 30 µg sprifermin every 6 months (q6mo); 30 µg sprifermin every 12 months (q12mo); 100 µg sprifermin q6mo; 100 µg sprifermin q12mo; or placebo. Post-hoc analysis using thinning/thickening scores and ordered values evaluated femorotibial cartilage thickness change from baseline to 24 months independent of location. Changes were indirectly compared with those of Osteoarthritis Initiative healthy subjects.
RESULTS


Thinning scores were significantly lower for sprifermin 100 µg q6mo versus placebo (mean (95% CI) difference: 334 µm (114 to 554)), with a cartilage thinning score similar to healthy subjects. Thickening scores were significantly greater for sprifermin 100 µg q6mo, 100 µg q12mo and 30 µg q6mo versus placebo (mean (95% CI) difference: 425 µm (267 to 584); 450 µm (305 to 594) and 139 µm (19 to 259), respectively) and more than doubled versus healthy subjects.
CONCLUSIONS


Sprifermin increases cartilage thickness, and substantially reduces cartilage loss, expanding FORWARD primary results.
TRIAL REGISTRATION NUMBER


NCT01919164.",2020,"RESULTS


Thinning scores were significantly lower for sprifermin 100 µg q6mo versus placebo (mean (95% CI) difference: 334 µm (114 to 554)), with a cartilage thinning score similar to healthy subjects.","['patients with knee osteoarthritis', 'Patients']","['placebo', 'Intra-articular sprifermin', 'sprifermin']","['cartilage loss', 'cartilage thinning score', 'Thinning scores', 'cartilage loss and increases cartilage thickness', 'Thickening scores', 'femorotibial cartilage thickness change', 'cartilage thickness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C3886604'}]","[{'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205400', 'cui_str': 'Thickened (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.141504,"RESULTS


Thinning scores were significantly lower for sprifermin 100 µg q6mo versus placebo (mean (95% CI) difference: 334 µm (114 to 554)), with a cartilage thinning score similar to healthy subjects.","[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Eckstein', 'Affiliation': 'Department of Imaging and Functional Musculoskeletal Research, Institute of Anatomy & Cell Biology, Paracelsus Medical University, Salzburg, Austria felix.eckstein@pmu.ac.at.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Kraines', 'Affiliation': 'Global Clinical Development - Immunology, EMD Serono Research and Development Institute, Inc, Billerica, Massachusetts, USA.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Aydemir', 'Affiliation': 'Global Biostatistics and Epidemiology, EMD Serono Reserach and Development Institute, Inc, Billerica, Massachusetts, USA.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Wirth', 'Affiliation': 'Department of Imaging and Functional Musculoskeletal Research, Institute of Anatomy & Cell Biology, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Maschek', 'Affiliation': 'Department of Imaging and Functional Musculoskeletal Research, Institute of Anatomy & Cell Biology, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Marc C', 'Initials': 'MC', 'LastName': 'Hochberg', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland, USA.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216453']
424,32271144,Comparative pharmacokinetics of a montelukast/levocetirizine fixed-dose combination chewable tablet versus individual administration of montelukast and levocetirizine after a single oral administration in healthy Korean male subjects
.,"OBJECTIVE


Asthma patients often have co-existing symptoms of allergic rhinitis and are often prescribed with both asthma and rhinitis treatments such as montelukast and levocetirizine. The objective of this study was to compare the pharmacokinetic profiles of a montelukast/levocetirizine fixed-dose combination chewable tablet with individual administration of montelukast and levocetirizine in healthy subjects.
MATERIALS AND METHODS


A randomized, open-label, single-dose crossover study was conducted in healthy male subjects. One of the following treatments was administered in each period: co-administration of 1 chewable tablet of montelukast 5 mg and 1 tablet of levocetirizine 5 mg or administration of 1 chewable tablet of montelukast/levocetirizine 5/5 mg fixed-dose combination. Serial blood samples were collected up to 48 hours post dose. Plasma drug concentrations were measured by liquid chromatography/tandem mass spectrometry. Pharmacokinetic parameters, including maximum plasma concentration (C max ) and area under the plasma concentration versus time curve from dosing to the last measurable concentration (AUC last ), were determined by non-compartmental analysis. The geometric least-square mean (GLSM) ratios and associated 90% confidence intervals (CIs) of C max  and AUC last  were calculated to evaluate pharmacokinetic equivalence.
RESULTS


A total of 22 subjects were included in pharmacokinetic analysis. The GLSM ratios and 90% CIs of C max  and AUC last  were 1.0054 (0.9535 - 1.0601) and 1.0628 (1.0013 - 1.1281) for montelukast and 1.0105 (0.9488 - 1.0764) and 1.0396 (0.9935 - 1.0879) for levocetirizine, respectively.
CONCLUSION


The pharmacokinetic parameters of montelukast and levocetirizine when administered as separate tablets or as a fixed-dose combination were compared, and the parameters met the pharmacokinetic equivalence criteria. (ClinicalTrials.gov Identifier: NCT03371849).",2020,"AUC last  were 1.0054 (0.9535 - 1.0601) and 1.0628 (1.0013 - 1.1281) for montelukast and 1.0105 (0.9488 - 1.0764) and 1.0396 (0.9935 - 1.0879) for levocetirizine, respectively.
","['healthy Korean male subjects\u2029', 'healthy subjects', 'healthy male subjects', 'Asthma patients often have co-existing symptoms of allergic rhinitis', 'A total of 22 subjects were included in pharmacokinetic analysis']","['montelukast/levocetirizine', 'montelukast and levocetirizine', 'levocetirizine', 'montelukast']","['Serial blood samples', 'maximum plasma concentration (C max ) and area under the plasma concentration versus time curve from dosing to the last measurable concentration (AUC last ', 'geometric least-square mean (GLSM) ratios and associated 90% confidence intervals (CIs) of C max  and AUC last', 'Plasma drug concentrations']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0298130', 'cui_str': 'montelukast'}, {'cui': 'C1174893', 'cui_str': 'levocetirizine'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",22.0,0.0603691,"AUC last  were 1.0054 (0.9535 - 1.0601) and 1.0628 (1.0013 - 1.1281) for montelukast and 1.0105 (0.9488 - 1.0764) and 1.0396 (0.9935 - 1.0879) for levocetirizine, respectively.
","[{'ForeName': 'Seol Ju', 'Initials': 'SJ', 'LastName': 'Moon', 'Affiliation': ''}, {'ForeName': 'Kyung-Sang', 'Initials': 'KS', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Jina', 'Initials': 'J', 'LastName': 'Jung', 'Affiliation': ''}, {'ForeName': 'Yong-Il', 'Initials': 'YI', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Min-Gul', 'Initials': 'MG', 'LastName': 'Kim', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203709']
425,32289474,"5-Year Update of a Multi-Institution, Prospective Phase 2 Hypofractionated Postmastectomy Radiation Therapy Trial.","PURPOSE


Hypofractionation in the setting of postmastectomy radiation (PMRT) is not currently the standard of care in most countries. Here we present a 5-year update of our multi-institutional, phase 2 prospective trial evaluating a novel 15-day hypofractionated PMRT regimen.
METHODS AND MATERIALS


Patients were enrolled to receive 3.33 Gy daily to the chest wall (or reconstructed breast) and regional lymphatics in 11 fractions with an optional 4-fraction mastectomy scar boost. The primary endpoint was freedom from grade 3 or higher late non-reconstruction-related radiation toxicities. Toxicities were scored using Common Terminology Criteria for Adverse Events v4.0. Secondary endpoints included local and locoregional recurrence rates, cosmesis, and reconstruction complications.
RESULTS


After enrolling 69 patients with stage II-IIIa breast cancer, 67 women were eligible for analysis. At a median follow up of 54 months, there were no acute or late grade 3 and 4 nonreconstruction reported toxicities. The grade 2 or greater late toxicity rate was only 12% and comprised grade 2 pain, fatigue, and lymphedema that persisted beyond 6 months after completion of radiation therapy. Only 3 women (4.6%) experienced a chest wall or nodal recurrence as a first site of relapse. Freedom from local failure, including local failure after distant relapse, was 92% at 5 years, and the 5-year overall survival was 90%.
CONCLUSIONS


This is the first prospective trial conducted in the United States to demonstrate the safe and effective use of hypofractionated PMRT. We have demonstrated a low complication rate while achieving excellent local control. Toxicity was better than anticipated based on previously published series of PMRT toxicities. Although our fractionation was novel, the radiobiological equivalent dose is similar to other hypofractionation schedules. This trial was the basis for the creation of Alliance A221505 (RT CHARM), which is currently accruing patients in a phase 3 randomized design.",2020,"Freedom from local failure, including local failure after distant relapse was 92% at 5 years and the 5-year overall survival was 90%.
","['Patients were enrolled to receive 3.33 Gray (Gy) daily to the', '69 patients with stage II-IIIa breast cancer, 67 women were eligible for analysis']","['post mastectomy radiation (PMRT', 'chest wall (or reconstructed breast) and regional lymphatics in 11 fractions with an optional 4 fraction mastectomy scar boost', 'Alliance Axxxxx (xxxxx', 'hypofractionated PMRT']","['late toxicity rate', 'low complication rate', 'toxicities', 'local failure after distant relapse', 'chest wall or nodal recurrence', 'Toxicities', 'Toxicity', 'freedom from grade 3 or higher late non-reconstruction related radiation toxicities', 'pain, fatigue and lymphedema', 'local and locoregional recurrence rates, cosmesis and reconstruction complications', '5-year overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517690', 'cui_str': '3.33'}, {'cui': 'C0556636', 'cui_str': 'Gy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205076', 'cui_str': 'Chest wall structure'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205076', 'cui_str': 'Chest wall structure'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1510432', 'cui_str': 'Radiation sickness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",69.0,0.105768,"Freedom from local failure, including local failure after distant relapse was 92% at 5 years and the 5-year overall survival was 90%.
","[{'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Poppe', 'Affiliation': 'Huntsman Cancer Hospital, University of Utah, Salt Lake City, Utah. Electronic address: matthew.poppe@hci.utah.edu.'}, {'ForeName': 'Zeinab A', 'Initials': 'ZA', 'LastName': 'Yehia', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Baker', 'Affiliation': 'Huntsman Cancer Hospital, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Sharad', 'Initials': 'S', 'LastName': 'Goyal', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Toppmeyer', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Kirstein', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York City, New York.'}, {'ForeName': 'Chunxia', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Rutgers School of Public Health, Piscataway, New Jersey.'}, {'ForeName': 'D F', 'Initials': 'DF', 'LastName': 'Moore', 'Affiliation': 'Rutgers School of Public Health, Piscataway, New Jersey.'}, {'ForeName': 'Bruce G', 'Initials': 'BG', 'LastName': 'Haffty', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Atif J', 'Initials': 'AJ', 'LastName': 'Khan', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York City, New York.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.03.020']
426,32289190,Safety in moderate-to-severe plaque psoriasis patients with latent tuberculosis treated with guselkumab and anti-tuberculosis treatments concomitantly: results from pooled phase 3 VOYAGE 1 & VOYAGE 2 trials.,"BACKGROUND


Patients treated with tumour necrosis factor (TNF) inhibitors are at risk of new-onset tuberculosis (TB) or reactivation of latent tuberculosis infection (LTBI). Association between TB/LTBI and interleukin (IL)-23 inhibitors for psoriasis is unclear. Patients with LTBI typically initiate LTBI therapy before receiving biologics.
OBJECTIVES


Safety in moderate-to-severe psoriasis patients with LTBI treated with guselkumab (IL-23 inhibitor) and LTBI treatment was evaluated.
METHODS


In the VOYAGE 1 & VOYAGE 2 studies, patients screened for LTBI were randomized to guselkumab, placebo, or adalimumab (TNF inhibitor) at baseline. Placebo → guselkumab crossover occurred at week 16 and adalimumab → guselkumab at week 52 (VOYAGE 1), or at week 28 or later (VOYAGE 2). Incidence of active TB, adverse events (AEs), serious AEs (SAEs), and markedly abnormal liver function tests [alanine aminotransferase test (ALT); aspartate aminotransferase test (AST)] were evaluated using pooled data through week 100 in guselkumab-treated patients receiving and not receiving LTBI treatment.
RESULTS


At baseline, 130 randomized patients (guselkumab: n = 69; adalimumab: n = 36; placebo: n = 25) tested positive for LTBI and received concomitant LTBI treatments (LTBI+). No active TB was reported among guselkumab-treated patients without LTBI (LTBI-) through week 100. Two cases of active TB occurred in LTBI- patients treated with adalimumab. Through week 16, across all treatment groups, greater proportions of LTBI+ patients reported ALT and AST elevations compared with LTBI- patients. Through week 100, proportions of patients experiencing AEs and SAEs were comparable between LTBI+ and LTBI- patients.
CONCLUSIONS


No cases of active TB, including reactivation of LTBI, were reported in patients with or without LTBI treated with guselkumab through up to 2 years. LTBI treatment was effective across all treatment groups in preventing reactivation of LTBI. Long-term treatment with guselkumab was generally well-tolerated through up to 2 years in patients receiving LTBI medications.",2020,"Through wk100, proportions of patients experiencing AEs and SAEs were comparable between LTBI+ and LTBI- patients.
","['130 randomized patients (guselkumab: n=69', 'Patients with LTBI typically initiate LTBI therapy before receiving biologics', 'moderate-to-severe plaque psoriasis patients with latent tuberculosis treated with', 'moderate-to-severe psoriasis patients with LTBI treated with']","['LTBI', 'guselkumab (IL-23 inhibitor', 'tumor necrosis factor (TNF) inhibitors', 'placebo', 'guselkumab and anti-tuberculosis', 'guselkumab, placebo, or adalimumab (TNF inhibitor', 'adalimumab', 'LTBI and received concomitant LTBI treatments (LTBI', 'Placebo→guselkumab', 'guselkumab']","['active TB', 'ALT and AST elevations', 'active TB, including reactivation of LTBI', 'Incidence of active TB, adverse events (AEs), serious AEs (SAEs) and markedly abnormal liver function tests (alanine aminotransferase test [ALT]; aspartate aminotransferase test [AST']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C1609538', 'cui_str': 'Inactive tuberculosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C1609538', 'cui_str': 'Inactive tuberculosis'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C0963088', 'cui_str': 'IL-23'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1609538', 'cui_str': 'Inactive tuberculosis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0151766', 'cui_str': 'Liver function tests abnormal'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",130.0,0.0864569,"Through wk100, proportions of patients experiencing AEs and SAEs were comparable between LTBI+ and LTBI- patients.
","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Puig', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'T-F', 'Initials': 'TF', 'LastName': 'Tsai', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bhutani', 'Affiliation': 'University of California San Francisco Medical Center, San Francisco, CA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Uy', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ramachandran', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': 'SKiN Centre for Dermatology, Peterborough, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16460']
427,32291360,The Effect of an Anti-Bullying Intervention on Male Students' Bullying-victimization Behaviors and Social Competence: A Randomized Controlled Trial in Deprived Urban Areas.,"BACKGROUND


Violence among adolescents is a global public health concern. There is limited evidence on the effectiveness of anti-bullying interventions in Iran. Weaimed to examine the effectiveness of social cognitive theory (SCT)-based intervention on reducing bullying and victimization in elementary school students.
STUDY DESIGN


A randomized controlled trial.
METHODS


Eight elementary schools (consisted of 280 students in 5th and 6th grade) from deprived and semi-deprived areas of Kermanshah (west of Iran) were randomly assigned to intervention and control group from 2018 to 2019. Anti-bullying training content appropriate for SCT and sociocultural characteristics were provided to the intervention group including students, parents, teachers and school staff. The measures included SCT constructs, bullying, victimization, and social competence of students.
RESULTS


At baseline participants of two groups were homogenous in terms of demographic factors except for the type of living with the parent (P=0.040) and outcome variables including SCT constructs and bullying behaviors. The interventions significantly improved SCT constructs, reduced bullying and victimization and increased social competence in the intervention group compared to the control group (P<0.001). The difference between outcome expectations in both groups was not significant (P=0.137).
CONCLUSION


Interventions based on sociocultural characteristics and focuses on SCT theory reduce bullying and victimization behavior. Given the effectiveness and feasibility of these interventions, this theory can be effective to break the bullying cycle and improve social competence.",2019,"The interventions significantly improved SCT constructs, reduced bullying and victimization and increased social competence in the intervention group compared to the control group (P<0.001).","['elementary school students', 'Eight elementary schools (consisted of 280 students in 5th and 6th grade) from deprived and semi-deprived areas of Kermanshah (west of Iran', 'Deprived Urban Areas', ""Male Students' Bullying-victimization Behaviors and Social Competence""]","['Anti-Bullying Intervention', 'social cognitive theory (SCT)-based intervention']","['SCT constructs, reduced bullying and victimization and increased social competence', 'SCT constructs and bullying behaviors', 'SCT constructs, bullying, victimization, and social competence of students']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}]","[{'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",,0.0410674,"The interventions significantly improved SCT constructs, reduced bullying and victimization and increased social competence in the intervention group compared to the control group (P<0.001).","[{'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Salimi', 'Affiliation': 'Department of Public Health, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Karimi-Shahanjarini', 'Affiliation': 'Department of Public Health, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran. karimi.a@umsha.ac.ir.'}, {'ForeName': 'Forouzan', 'Initials': 'F', 'LastName': 'Rezapur-Shahkolai', 'Affiliation': 'Department of Public Health, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Behrooz', 'Initials': 'B', 'LastName': 'Hamzeh', 'Affiliation': 'Research Center for Environmental Determinants of Health, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Ghodratollah', 'Initials': 'G', 'LastName': 'Roshanaei', 'Affiliation': 'Department of Biostatistics, Modeling of Noncommunicable Disease Research Canter, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Babamiri', 'Affiliation': 'Social Determinants of Health Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Journal of research in health sciences,[]
428,27418545,Reductions in carotid chemoreceptor activity with low-dose dopamine improves baroreflex control of heart rate during hypoxia in humans.,"The purpose of the present investigation was to examine the contribution of the carotid body chemoreceptors to changes in baroreflex control of heart rate with exposure to hypoxia. We hypothesized spontaneous cardiac baroreflex sensitivity (scBRS) would be reduced with hypoxia and this effect would be blunted when carotid chemoreceptor activity was reduced with low-dose dopamine. Fifteen healthy adults (11 M/4 F) completed two visits randomized to intravenous dopamine or placebo (saline). On each visit, subjects were exposed to 5-min normoxia (~99% SpO2), followed by 5-min hypoxia (~84% SpO2). Blood pressure (intra-arterial catheter) and heart rate (ECG) were measured continuously and scBRS was assessed by spectrum and sequence methodologies. scBRS was reduced with hypoxia (P < 0.01). Using the spectrum analysis approach, the fall in scBRS with hypoxia was attenuated with infusion of low-dose dopamine (P < 0.01). The decrease in baroreflex sensitivity to rising pressures (scBRS ""up-up"") was also attenuated with low-dose dopamine (P < 0.05). However, dopamine did not attenuate the decrease in baroreflex sensitivity to falling pressures (scBRS ""down-down""; P > 0.05). Present findings are consistent with a reduction in scBRS with systemic hypoxia. Furthermore, we show this effect is partially mediated by the carotid body chemoreceptors, given the fall in scBRS is attenuated when activity of the chemoreceptors is reduced with low-dose dopamine. However, the improvement in scBRS with dopamine appears to be specific to rising blood pressures. These results may have important implications for impairments in baroreflex function common in disease states of acute and/or chronic hypoxemia, as well as the experimental use of dopamine to assess such changes.",2016,scBRS was reduced with hypoxia (P < 0.01).,"['humans', 'Fifteen healthy adults (11 M/4 F']","['intravenous dopamine or placebo (saline', 'dopamine']","['baroreflex sensitivity to rising pressures (scBRS ', 'baroreflex control of heart rate', 'Blood pressure (intra-arterial catheter) and heart rate (ECG', 'carotid chemoreceptor activity', 'scBRS', 'baroreflex sensitivity']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0206162', 'cui_str': 'Reflex, Baroreceptor'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0694634', 'cui_str': 'Intra-arterial (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",15.0,0.0528425,scBRS was reduced with hypoxia (P < 0.01).,"[{'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Mozer', 'Affiliation': 'Department of Anesthesiology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Walter W', 'Initials': 'WW', 'LastName': 'Holbein', 'Affiliation': 'Department of Anesthesiology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Joyner', 'Affiliation': 'Department of Anesthesiology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Curry', 'Affiliation': 'Department of Anesthesiology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jacqueline K', 'Initials': 'JK', 'LastName': 'Limberg', 'Affiliation': 'Department of Anesthesiology, Mayo Clinic, Rochester, Minnesota limberg.jacqueline@mayo.edu.'}]",Physiological reports,['10.14814/phy2.12859']
429,32291620,Efficacy of furosemide-albumin compared with furosemide in critically ill hypoalbuminemia patients admitted to intensive care unit: a prospective randomized clinical trial.,"BACKGROUND


Some physicians co-administer albumin with loop diuretics to overcome diuretic resistance in critically ill hypoalbuminemia patients, though previous studies have reported conflicting results on this matter.
OBJECTIVE


The effects of adding albumin to furosemide to enhance its efficacy in critically ill hypoalbuminemia patients are evaluated.
METHODS


This was a non-blinded randomized trial. 49 adult critically ill patients with hypoalbuminemia and generalized edema who received randomly furosemide and furosemide/albumin complex were enrolled. The patients' urine was collected at intervals of 2, 4, 6 and 8 h after initiation of the furosemide treatment, and the urine output and urinary excretion of furosemide and sodium were measured. The urinary excretion of furosemide was considered an indicator of drug efficacy.
RESULTS


The amount of sodium and furosemide excreted in urine showed no significant differences between the two groups; however, the mean of the urinary excretion of furosemide in the first 2 h after drug infusion was significantly higher (p = 0.03) in the furosemide/albumin group. No significant correlation between APACHE II scores and serum albumin levels and the urinary excretion of furosemide was seen.
CONCLUSION


The results indicated that there is not statistically significant differences between groups with furosemide alone and combined with albumin in urinary furosemide excretion. It seems that adding albumin for furosemide pharmacotherapy regime is not recommended as an intervention to increase furosemide efficacy in critically ill hypoalbuminemia patients.
TRIAL REGISTRATION


IRCT with the registration number IRCT201412132582N12 in 23 February 2015; https://en.irct.ir/trial/2356 Graphical abstract.",2020,"The amount of sodium and furosemide excreted in urine showed no significant differences between the two groups; however, the mean of the urinary excretion of furosemide in the first 2 h after drug infusion was significantly higher (p = 0.03) in the furosemide/albumin group.","['49 adult critically ill patients with hypoalbuminemia and generalized edema who received', 'critically ill hypoalbuminemia patients', 'critically ill hypoalbuminemia patients admitted to intensive care unit', '23 February 2015; https://en.irct.ir/trial/2356 Graphical abstract']","['furosemide-albumin', 'albumin to furosemide', 'furosemide', 'randomly furosemide and furosemide/albumin complex']","['APACHE II scores and serum albumin levels', 'urinary excretion of furosemide', 'furosemide efficacy', 'urine output and urinary excretion of furosemide and sodium', 'urinary furosemide excretion']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0239981', 'cui_str': 'Hypoalbuminemia'}, {'cui': 'C0151603', 'cui_str': 'Anasarca'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}]","[{'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]","[{'cui': 'C0489438', 'cui_str': 'APACHE II score'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}]",49.0,0.10447,"The amount of sodium and furosemide excreted in urine showed no significant differences between the two groups; however, the mean of the urinary excretion of furosemide in the first 2 h after drug infusion was significantly higher (p = 0.03) in the furosemide/albumin group.","[{'ForeName': 'Ata', 'Initials': 'A', 'LastName': 'Mahmoodpoor', 'Affiliation': 'Department of Anesthesiology, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Sahra', 'Initials': 'S', 'LastName': 'Zahedi', 'Affiliation': 'Iranian Evidence Based Medicine Center of Excellence, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Arezou', 'Initials': 'A', 'LastName': 'Pourakbar', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Hamishehkar', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Shadvar', 'Affiliation': 'Department of Anesthesiology, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Parina', 'Initials': 'P', 'LastName': 'Asgharian', 'Affiliation': 'Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Shahabi', 'Affiliation': 'Department of Anesthesiology, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Hamishehkar', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. hamishehkar@gmail.com.'}]","Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences",['10.1007/s40199-020-00339-8']
430,31722153,Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer.,"BACKGROUND


Secondary surgical cytoreduction in women with platinum-sensitive, recurrent epithelial ovarian, primary peritoneal, or fallopian-tube (""ovarian"") cancer is widely practiced but has not been evaluated in phase 3 investigation.
METHODS


We randomly assigned patients with recurrent ovarian cancer who had received one previous therapy, had an interval during which no platinum-based chemotherapy was used (platinum-free interval) of 6 months or more, and had investigator-determined resectable disease (to no macroscopic residual disease) to undergo secondary surgical cytoreduction and then receive platinum-based chemotherapy or to receive platinum-based chemotherapy alone. Adjuvant chemotherapy (paclitaxel-carboplatin or gemcitabine-carboplatin) and use of bevacizumab were at the discretion of the investigator. The primary end point was overall survival.
RESULTS


A total of 485 patients underwent randomization, 240 to secondary cytoreduction before chemotherapy and 245 to chemotherapy alone. The median follow-up was 48.1 months. Complete gross resection was achieved in 67% of the patients assigned to surgery who underwent the procedure. Platinum-based chemotherapy with bevacizumab followed by bevacizumab maintenance was administered to 84% of the patients overall and was equally distributed between the two groups. The hazard ratio for death (surgery vs. no surgery) was 1.29 (95% confidence interval [CI], 0.97 to 1.72; P = 0.08), which corresponded to a median overall survival of 50.6 months and 64.7 months, respectively. Adjustment for platinum-free interval and chemotherapy choice did not alter the effect. The hazard ratio for disease progression or death (surgery vs. no surgery) was 0.82 (95% CI, 0.66 to 1.01; median progression-free survival, 18.9 months and 16.2 months, respectively). Surgical morbidity at 30 days was 9%; 1 patient (0.4%) died from postoperative complications. Patient-reported quality of life decreased significantly after surgery but did not differ significantly between the two groups after recovery.
CONCLUSIONS


In this trial involving patients with platinum-sensitive, recurrent ovarian cancer, secondary surgical cytoreduction followed by chemotherapy did not result in longer overall survival than chemotherapy alone. (Funded by the National Cancer Institute and others; GOG-0213 ClinicalTrials.gov number, NCT00565851.).",2019,"The hazard ratio for disease progression or death (surgery vs. no surgery) was 0.82 (95% CI, 0.66 to 1.01; median progression-free survival, 18.9 months and 16.2 months, respectively).","['patients with platinum-sensitive, recurrent ovarian cancer, secondary surgical cytoreduction followed by', 'women with platinum-sensitive, recurrent epithelial ovarian, primary peritoneal, or fallopian-tube (""ovarian"") cancer', '485 patients underwent randomization, 240 to secondary cytoreduction before chemotherapy and 245 to chemotherapy alone', 'We randomly assigned patients with recurrent ovarian cancer who had received one previous therapy, had an interval during which no platinum-based chemotherapy was used (platinum-free interval) of 6 months or more, and had investigator-determined resectable disease (to no macroscopic residual disease) to undergo secondary surgical cytoreduction and then receive', 'Recurrent Ovarian Cancer']","['Adjuvant chemotherapy (paclitaxel-carboplatin or gemcitabine-carboplatin', 'Platinum-based chemotherapy with bevacizumab', 'platinum-based chemotherapy or to receive platinum-based chemotherapy alone', 'chemotherapy', 'bevacizumab', 'bevacizumab maintenance']","['Surgical morbidity', 'quality of life', 'hazard ratio for disease progression or death', 'overall survival', 'Complete gross resection', 'median overall survival', 'median progression-free survival', 'hazard ratio for death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0034380'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",485.0,0.29698,"The hazard ratio for disease progression or death (surgery vs. no surgery) was 0.82 (95% CI, 0.66 to 1.01; median progression-free survival, 18.9 months and 16.2 months, respectively).","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Nick M', 'Initials': 'NM', 'LastName': 'Spirtos', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Enserro', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Herzog', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sabbatini', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Deborah K', 'Initials': 'DK', 'LastName': 'Armstrong', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Jae-Weon', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Sang-Yoon', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Byoung-Gie', 'Initials': 'BG', 'LastName': 'Kim', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Joo-Hyun', 'Initials': 'JH', 'LastName': 'Nam', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fujiwara', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Walker', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Casey', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Angeles', 'Initials': 'A', 'LastName': 'Alvarez Secord', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Rubin', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Chan', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'DiSilvestro', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Davidson', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Cohn', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Krishnansu S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Basen-Engquist', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Helen Q', 'Initials': 'HQ', 'LastName': 'Huang', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Mark F', 'Initials': 'MF', 'LastName': 'Brady', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Mannel', 'Affiliation': ""From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).""}]",The New England journal of medicine,['10.1056/NEJMoa1902626']
431,30959514,Neurophysiological signature of gamma-hydroxybutyrate augmented sleep in male healthy volunteers may reflect biomimetic sleep enhancement: a randomized controlled trial.,"Gamma-hydroxybutyrate (GHB) is an endogenous GHB/GABA B  receptor agonist, which has demonstrated potency in consolidating sleep and reducing excessive daytime sleepiness in narcolepsy. Little is known whether GHB's efficacy reflects the promotion of physiological sleep mechanisms and no study has investigated its sleep consolidating effects under low sleep pressure. GHB (50 mg/kg p.o.) and placebo were administered in 20 young male volunteers at 2:30 a.m., the time when GHB is typically given in narcolepsy, in a randomized, double-blinded, crossover manner. Drug effects on sleep architecture and electroencephalographic (EEG) sleep spectra were analyzed. In addition, current source density (CSD) analysis was employed to identify the effects of GHB on the brain electrical sources of neuronal oscillations. Moreover, lagged-phase synchronization (LPS) analysis was applied to quantify the functional connectivity among sleep-relevant brain regions. GHB prolonged slow-wave sleep (stage N3) at the cost of rapid eye movement (REM) sleep. Furthermore, it enhanced delta-theta (0.5-8 Hz) activity in NREM and REM sleep, while reducing activity in the spindle frequency range (13-15 Hz) in sleep stage N2. The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex. Theta power was particularly increased in the prefrontal cortex and both temporal poles. Moreover, the brain areas that showed increased theta power after GHB also exhibited increased lagged-phase synchronization among each other. Our study in healthy men revealed distinct similarities between GHB-augmented sleep and physiologically augmented sleep as seen in recovery sleep after prolonged wakefulness. The promotion of the sleep neurophysiological mechanisms by GHB may thus provide a rationale for GHB-induced sleep and waking quality in neuropsychiatric disorders beyond narcolepsy.",2019,"The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex.","['20 young male volunteers', 'healthy men', 'male healthy volunteers']","['gamma-hydroxybutyrate augmented sleep', 'placebo', 'GHB', 'Gamma-hydroxybutyrate (GHB']","['sleep architecture and electroencephalographic (EEG) sleep spectra', 'delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex', 'biomimetic sleep enhancement', 'GHB prolonged slow-wave sleep (stage N3', 'Theta power']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0000503', 'cui_str': '4-Hydroxybutyrate (substance)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0332251', 'cui_str': 'Predominate (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0228243', 'cui_str': 'Gyrus Fusiformis'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C0872312', 'cui_str': 'Biomimicry Engineering'}, {'cui': 'C0184578', 'cui_str': 'Sleep/wake cycle facilitation'}, {'cui': 'C0000503', 'cui_str': '4-Hydroxybutyrate (substance)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}]",20.0,0.0596478,"The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex.","[{'ForeName': 'Dario A', 'Initials': 'DA', 'LastName': 'Dornbierer', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland. dornbierer@pharma.uzh.ch.'}, {'ForeName': 'Diego M', 'Initials': 'DM', 'LastName': 'Baur', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Stucky', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Boris B', 'Initials': 'BB', 'LastName': 'Quednow', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kraemer', 'Affiliation': 'Department of Forensic Pharmacology and Toxicology, Zurich Institute of Forensic Medicine, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Seifritz', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Oliver G', 'Initials': 'OG', 'LastName': 'Bosch', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Landolt', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0382-z']
432,32284339,Neurofeedback-Linked Suppression of Cortical β Bursts Speeds Up Movement Initiation in Healthy Motor Control: A Double-Blind Sham-Controlled Study.,"Abnormally increased β bursts in cortical-basal ganglia-thalamic circuits are associated with rigidity and bradykinesia in patients with Parkinson's disease. Increased β bursts detected in the motor cortex have also been associated with longer reaction times (RTs) in healthy participants. Here we further hypothesize that suppressing β bursts through neurofeedback training can improve motor performance in healthy subjects. We conducted a double-blind sham-controlled study on 20 human volunteers (10 females) using a sequential neurofeedback-behavior task with the neurofeedback reflecting the occurrence of β bursts over sensorimotor cortex quantified in real time. The results show that neurofeedback training helps healthy participants learn to volitionally suppress β bursts in the sensorimotor cortex, with training being accompanied by reduced RT in subsequent cued movements. These changes were only significant in the real feedback group but not in the sham group, confirming the effect of neurofeedback training over simple motor imagery. In addition, RTs correlated with the rate and accumulated duration of β bursts in the contralateral motor cortex before the go-cue, but not with averaged β power. The reduced RTs induced by neurofeedback training positively correlated with reduced β bursts across all tested hemispheres. These results strengthen the link between the occurrence of β bursts in the sensorimotor cortex before the go-cue and slowed movement initiation in healthy motor control. The results also highlight the potential benefit of neurofeedback training in facilitating voluntary suppression of β bursts to speed up movement initiation. SIGNIFICANCE STATEMENT  This double-blind sham-controlled study suggested that neurofeedback training can facilitate volitional suppression of β bursts in sensorimotor cortex in healthy motor control better than sham feedback. The training was accompanied by reduced reaction time (RT) in subsequent cued movements, and the reduced RT positively correlated with the level of reduction in cortical β bursts before the go-cue, but not with average β power. These results provide further evidence of a causal link between sensorimotor β bursts and movement initiation and suggest that neurofeedback training could potentially be used to train participants to speed up movement initiation.",2020,"These changes were only significant in the real feedback group but not in the sham group, confirming the effect of neurofeedback training over simple motor imagery.","['healthy subjects', '20 human volunteers (10 females', 'healthy participants', ""patients with Parkinson's disease"", 'healthy motor control']","['neurofeedback training', 'sequential neurofeedback-behaviour task']","['reaction time', 'rigidity and bradykinesia', 'reduced reaction time in subsequent cued movements', 'reduced reaction times', 'motor performance']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",20.0,0.0558813,"These changes were only significant in the real feedback group but not in the sham group, confirming the effect of neurofeedback training over simple motor imagery.","[{'ForeName': 'Shenghong', 'Initials': 'S', 'LastName': 'He', 'Affiliation': 'MRC Brain Network Dynamics Unit at the University of Oxford, United Kingdom Oxford OX1 3TH.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Everest-Phillips', 'Affiliation': 'MRC Brain Network Dynamics Unit at the University of Oxford, United Kingdom Oxford OX1 3TH.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Clouter', 'Affiliation': 'MRC Brain Network Dynamics Unit at the University of Oxford, United Kingdom Oxford OX1 3TH.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brown', 'Affiliation': 'MRC Brain Network Dynamics Unit at the University of Oxford, United Kingdom Oxford OX1 3TH.'}, {'ForeName': 'Huiling', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'MRC Brain Network Dynamics Unit at the University of Oxford, United Kingdom Oxford OX1 3TH huiling.tan@ndcn.ox.ac.uk.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.0208-20.2020']
433,32285979,Effectiveness of nicotine gum in preventing lapses in the face of temptation to smoke among non-daily smokers: a secondary analysis.,"BACKGROUND AND AIMS


Non-daily smokers (NDS) comprise a large fraction of US smokers. Despite little or no dependence, as typically assessed, intermittent smokers (ITS) have difficulty quitting smoking. A randomized clinical trial comparing the effect of nicotine gum with placebo on quitting smoking in non-daily smokers did not find an effect on overall abstinence. We undertook an analysis to assess whether using nicotine gum versus placebo when tempted to smoke could reduce incidence of lapses in those situations.
DESIGN


Within a 6-week randomized, placebo-controlled clinical trial of nicotine gum, analyses contrasted the outcome of temptation episodes where gum was or was not used.
SETTING


Smoking cessation research clinic in Pittsburgh, PA, USA.
PARTICIPANTS


A total of 255 adult ITS (131 nicotine gum, 124 placebo) seeking help for smoking cessation.
INTERVENTION


Nicotine gum (2 mg) versus placebo for up to 8 weeks, with as-needed dosing instructions.
MEASUREMENTS


Outcome was lapsing in temptation episodes, as reported by participants via ecological momentary assessment (EMA). Propensity scores predicting gum use from situational factors (e.g. mood, social setting, smoking cues) served as a control variable.
FINDINGS


Participants reported 2713 temptation episodes, 46.0% (1248) of which resulted in smoking (lapsing). There was a significant gum use × active treatment interaction (P = 0.0009). Using nicotine gum decreased the odds of lapsing by 55% compared with using placebo [odds ratio (OR) = 0.45; 0.22-0.94]; when gum was not used, the assigned gum condition made no significant difference (OR = 1.53; 0.78-3.01; Bayes factor = 0.14). The nicotine effect was not reliably different when participants were trying to achieve abstinence versus when trying to maintain abstinence (OR = 0.44; 0.10, 2.03; P = 0.294; Bayes factor = 0.11), for men and women (OR = 1.68; 0.58, 4.87; P = 0.343; Bayes factor = 0.10), or for participants with some or no dependence (OR = 0.88; 0.30, 2.59; P = 0.811; Bayes factor = 0.06).
CONCLUSIONS


When used in response to temptation to smoke, 2 mg nicotine gum can help to prevent lapses among non-daily smokers.",2020,"Using nicotine gum decreased the odds of lapsing by 55% compared with using placebo (OR=0.45, 0.22-0.94); when gum was not used, the assigned gum condition made no significant difference (OR=1.53, 0.78-3.01; Bayes Factor=0.14).","['temptation to smoke among non-daily smokers', 'non-daily smokers', 'Smoking cessation research clinic in Pittsburgh, PA, USA', 'Participants reported 2,713 temptation episodes, 46.0% (1,248) of which resulted in smoking (lapsing', '255 adult ITS (131 nicotine gum, 124 placebo) seeking help for smoking cessation']","['nicotine gum', 'Nicotine gum (2 mg) vs placebo', 'nicotine gum, vs placebo', 'placebo', 'nicotine gum with placebo']","['overall abstinence', 'quitting smoking', 'odds of lapsing', 'ecological momentary assessment (EMA']","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1880200', 'cui_str': 'Occasional tobacco smoker'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0599654', 'cui_str': 'Nicotine Chewing Gum'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0521125', 'cui_str': 'For'}]","[{'cui': 'C0599654', 'cui_str': 'Nicotine Chewing Gum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}]",,0.0231301,"Using nicotine gum decreased the odds of lapsing by 55% compared with using placebo (OR=0.45, 0.22-0.94); when gum was not used, the assigned gum condition made no significant difference (OR=1.53, 0.78-3.01; Bayes Factor=0.14).","[{'ForeName': 'Saul', 'Initials': 'S', 'LastName': 'Shiffman', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Stuart G', 'Initials': 'SG', 'LastName': 'Ferguson', 'Affiliation': 'College of Health and Medicine, University of Tasmania, Hobart, TAS, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Scholl', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Hedeker', 'Affiliation': 'Department of Public Health Sciences, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Tindle', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15083']
434,31696369,Crystal Clear with Active Visualization: Understanding Medication Adherence Among Youth Living with HIV.,"Adherence to antiretroviral therapy (ART) among youth remains low. We piloted an adapted active visualization device that demonstrates how ART works in the body. Youth living with HIV were randomized to: (1) standard care (n = 14) or the (2) adapted active visualization intervention (n = 14) and 71% of the sample (n = 19) were re-assessed on viral load, adherence behaviors, and illness perceptions 2.5 months later. Intervention youth had lower viral loads, reported less difficulty in adhering to ART, and more motivation and control over their HIV than standard care at follow-up. Active visualization may be an acceptable tool to address ART adherence among youth.",2020,"Intervention youth had lower viral loads, reported less difficulty in adhering to ART, and more motivation and control over their HIV than standard care at follow-up.","['Youth living with HIV', 'Youth Living with HIV']","['antiretroviral therapy (ART', 'Crystal Clear with Active Visualization', 'standard care (n\u2009=\u200914) or the (2) adapted active visualization intervention']",['lower viral loads'],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0427896', 'cui_str': 'Crystal - human material (substance)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",,0.0618946,"Intervention youth had lower viral loads, reported less difficulty in adhering to ART, and more motivation and control over their HIV than standard care at follow-up.","[{'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Christodoulou', 'Affiliation': 'Department of Psychiatry & Biobehavioral Sciences, Semel Institute, University of California Los Angeles, 10920, Wilshire Blvd., Suite 350, Los Angeles, CA, 90024, USA. JChristodoulou@mednet.ucla.edu.'}, {'ForeName': 'Sue Ellen', 'Initials': 'SE', 'LastName': 'Abdalian', 'Affiliation': 'School of Medicine, Tulane University, 1430 Tulane Ave, New Orleans, LA, 70112, USA.'}, {'ForeName': 'Annie S K', 'Initials': 'ASK', 'LastName': 'Jones', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Christodoulou', 'Affiliation': 'Keck School of Medicine, University of Southern California, 1975 Zonal Ave, Los Angeles, CA, 90033, USA.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Pentoney', 'Affiliation': 'Organovo, Inc., San Diego, CA, USA.'}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Rotheram-Borus', 'Affiliation': 'Department of Psychiatry & Biobehavioral Sciences, Semel Institute, University of California Los Angeles, 10920, Wilshire Blvd., Suite 350, Los Angeles, CA, 90024, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02721-3']
435,32285195,The Utility of Diaphragm Ultrasound in Reducing Time to Extubation.,"PURPOSE


Prediction of optimal timing for extubation of mechanically ventilated patients is challenging. Ultrasound measures of diaphragm thickness or diaphragm dome excursion have been used to aid in predicting extubation success or failure. The aim of this study was to determine if incorporating results of diaphragm ultrasound into usual ICU care would shorten the time to extubation.
METHODS


We performed a prospective, randomized, controlled study at three Brown University teaching hospitals. Included subjects underwent block randomization to either usual care (Control) or usual care enhanced with ultrasound measurements of the diaphragm (Intervention). The primary outcome was the time to extubation after ultrasound, and the secondary outcome was the total days on the ventilator. Only intensivists in the Intervention group would have the ultrasound information on the likelihood of successful extubation available to incorporate with traditional clinical and physiologic measures to determine the timing of extubation.
RESULTS


A total of 32 subjects were studied; 15 were randomized into the Control group and 17 into the Intervention group. The time from ultrasound to extubation was significantly reduced in the Intervention group compared to the Control group in patients with a ∆tdi% ≥ 30% (4.8 ± 8.4 vs 35.0 ± 41.0 h, p = 0.04). The time from ultrasound to extubation was shorter in subjects with a normally functioning diaphragm (∆tdi% ≥ 30%) compared to those with diaphragm dysfunction (∆tdi% < 30%) (23.2 ± 35.2 vs 57.3 ± 52.0 h p = 0.046). When combining the Intervention and Control groups, a value of ∆tdi% ≥ 30% for extubation success at 24 h provided a sensitivity, specificity, PPV and NPV of 90.9%, 86.7%, 90.9%, and 86.7%, respectively.
CONCLUSIONS


Diaphragm ultrasound evaluation of ∆tdi% aids in reducing time to extubation.",2020,"The time from ultrasound to extubation was significantly reduced in the Intervention group compared to the Control group in patients with a ∆tdi% ≥ 30% (4.8 ± 8.4 vs 35.0 ± 41.0 h, p = 0.04).","['three Brown University teaching hospitals', 'mechanically ventilated patients', 'A total of 32 subjects were studied; 15']","['Diaphragm Ultrasound', 'diaphragm ultrasound into usual ICU care', 'usual care (Control) or usual care enhanced with ultrasound measurements of the diaphragm (Intervention']","['time to extubation', 'sensitivity, specificity, PPV and NPV', 'total days on the ventilator', 'time from ultrasound to extubation', 'time to extubation after ultrasound']","[{'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0028586', 'cui_str': 'Nucleopolyhedrovirus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",32.0,0.0729494,"The time from ultrasound to extubation was significantly reduced in the Intervention group compared to the Control group in patients with a ∆tdi% ≥ 30% (4.8 ± 8.4 vs 35.0 ± 41.0 h, p = 0.04).","[{'ForeName': 'F Dennis', 'Initials': 'FD', 'LastName': 'McCool', 'Affiliation': 'Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Dennis O', 'Initials': 'DO', 'LastName': ""Oyieng'o"", 'Affiliation': ', 3311 E Murdock St 3rd floor, Wichita, KS, 67208, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Koo', 'Affiliation': 'University of Tennessee College of Medicine Chattanooga, Baroness Erlanger Hospital, 975 E 3rd Street, C-735, Chattanooga, TN, 37403, USA. drpkoo@gmail.com.'}]",Lung,['10.1007/s00408-020-00352-3']
436,32159882,Safety and efficacy of first-line dacomitinib in Japanese patients with advanced non-small cell lung cancer.,"In a subgroup of Japanese patients in the ARCHER 1050 randomized phase 3 trial, we evaluated the efficacy and safety and determined the effects of dose modifications on adverse events (AE) and therapy management of first-line oral dacomitinib 45 mg compared with oral gefitinib 250 mg, each once daily in 28-d cycles, in patients with EGFR-activating mutation-positive (EGFR-positive; exon 19 deletion or exon 21 L858R substitution mutations) advanced non-small cell lung cancer (NSCLC). The primary endpoint was progression-free survival (PFS; RECIST, version 1.1, by blinded independent review). In 81 Japanese patients (40 dacomitinib, 41 gefitinib), PFS was longer with dacomitinib compared with gefitinib (hazard ratio [HR], 0.544 [95% confidence interval {CI}, 0.307-0.961]; 2-sided P = .0327; median 18.2 for dacomitinib [95% CI, 11.0-31.3] mo, 9.3 [95% CI, 7.4-14.7] mo for gefitinib). The most common Grade 3 AEs were dermatitis acneiform with dacomitinib (27.5%) and increased alanine aminotransferase with gefitinib (12.2%). A higher proportion of patients receiving dacomitinib (85.0%) compared with gefitinib (24.4%) had AEs leading to dose reduction. Incidence and severity of diarrhea, dermatitis acneiform, stomatitis and paronychia were generally reduced after dacomitinib dose reductions and dacomitinib treatment duration was generally longer in patients with a dose reduction in comparison with those without a dose reduction. Our results confirmed the efficacy and safety of first-line dacomitinib in Japanese patients with EGFR-positive advanced NSCLC.",2020,"Incidence and severity of diarrhea, dermatitis acneiform, stomatitis and paronychia were generally reduced after dacomitinib dose reductions and dacomitinib treatment duration was generally longer in patients with a dose reduction in comparison with those without a dose reduction.","['81 Japanese patients', 'Japanese patients with EGFR-positive advanced NSCLC', 'Japanese patients with advanced non-small cell lung cancer']","['first-line dacomitinib', 'oral gefitinib', 'EGFR-activating mutation-positive (EGFR-positive; exon 19 deletion or exon 21 L858R substitution mutations) advanced non-small cell lung cancer (NSCLC']","['Safety and efficacy', 'progression-free survival', 'efficacy and safety', 'alanine aminotransferase', 'Incidence and severity of diarrhea, dermatitis acneiform, stomatitis and paronychia', 'dermatitis acneiform with dacomitinib']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C2987430'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0234894', 'cui_str': 'Dermatitis acneiform'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0030578', 'cui_str': 'Paronychia'}, {'cui': 'C2987430'}]",81.0,0.130685,"Incidence and severity of diarrhea, dermatitis acneiform, stomatitis and paronychia were generally reduced after dacomitinib dose reductions and dacomitinib treatment duration was generally longer in patients with a dose reduction in comparison with those without a dose reduction.","[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Nishio', 'Affiliation': 'Department of Thoracic Medical Oncology, The Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Thoracic Oncology, Kanagawa Cancer Center, Kanagawa, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Niho', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Nogami', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Shikoku Cancer Center, Ehime, Japan.'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Kaneda', 'Affiliation': 'Department of Clinical Oncology, Graduate School of Medicine, Osaka City University, Osaka, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Fujita', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Asahikawa Medical Center, Asahikawa, Japan.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wilner', 'Affiliation': 'Pfizer Oncology, La Jolla, CA, USA.'}, {'ForeName': 'Mizuki', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Pfizer R&D Japan, Tokyo, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Isozaki', 'Affiliation': 'Pfizer R&D Japan, Tokyo, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Wada', 'Affiliation': 'Pfizer R&D Japan, Tokyo, Japan.'}, {'ForeName': 'Fumito', 'Initials': 'F', 'LastName': 'Tsuji', 'Affiliation': 'SFJ Pharma Japan, Osaka, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.'}]",Cancer science,['10.1111/cas.14384']
437,32285978,Effect of e-cigarette advertisement themes on hypothetical e-cigarette purchasing in price-responsive adolescents.,"AIMS


To examine the effect on adolescents of exposure to different e-cigarette advertisement themes on reported likelihood of purchasing e-cigarettes in a hypothetical scenario.
DESIGN


Between-subjects design of four randomly assigned thematic conditions derived from a content analysis of 350 e-cigarette advertisements: general, flavor- and taste-themed, people- and product use-themed or control advertisements for bottled water.
SETTING


Virginia, USA.
PARTICIPANTS


Of 1360 adolescents (13-18 years old) participating, 1063 had complete data (519 current cigarette smokers, 544 tobacco-susceptible non-smokers).
MEASUREMENTS


Participants completed an e-cigarette purchase task, reporting the likelihood of buying an e-cigarette at various prices. Indices of abuse liability included price responsiveness (whether likelihood of purchase decreased with increasing prices) and, among price-responsive adolescents, breakpoint (highest price before definitely would not buy), maximum probability-weighted expenditure (O max  ) and price elasticity (how quickly willingness to purchase decreases as prices increase). Regressions controlled for demographics, prior tobacco ad exposure, tobacco/substance use and sensation-seeking.
FINDINGS


Prior advertisement exposure was positively associated with being price-responsive [odds ratio (OR) = 1.12, 95% confidence interval (CI) = 1.03, 1.22; P < 0.05]. Among price-responsive adolescents (n = 579), breakpoints were 58% higher in the flavor- and taste-themed condition (β = 0.46, 95% CI = <0.01, 0.92) and 75% higher in the people- and product use-themed condition (β = 0.56, 95% CI = 0.10, 1.03) compared with control (Ps < 0.05). Exposure to people- and product use-themed advertisements was associated with a 60% higher O max  (β = 0.47, 95% CI = 0.01, 0.93; P < 0.05). The general and people- and product use-themed conditions were associated with 19% (β = -0.21, 95% CI = -0.38, -0.04) and 21% (β = -0.24, 95% CI = -0.42, -0.06) lower elasticity, respectively (Ps < 0.05).
CONCLUSIONS


E-cigarette advertising exposure may increase reported likelihood of purchasing e-cigarettes, with effects differing by advertisement content. People- and product use-themed e-cigarette advertisements increased reported likelihood of purchasing in price-responsive adolescents.",2020,"FINDINGS


Prior ad exposure was positively associated with being price-responsive (OR 1.12, 95% CI 1.03, 1.22, p<0.05).","['Of 1360 adolescents (13-18 years old) participating, 1063 had complete data (519 current cigarette smokers, 544 tobacco-susceptible nonsmokers', 'Between-subjects design of four randomly-assigned thematic conditions derived from a content analysis of 350 e-cigarette ads: general', 'Virginia, USA', 'hypothetical e-cigarette purchasing in price-responsive adolescents', 'adolescents of exposure to different e-cigarette advertisement themes on reported likelihood of purchasing e-cigarettes in a hypothetical scenario']","['e-cigarette advertisement themes', 'flavor- and taste-themed, people- and product use-themed, or control ads for bottled water']","['e-cigarette purchase task, reporting the likelihood of buying an e-cigarette at various prices']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0042753', 'cui_str': 'Virginia'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1572482', 'cui_str': 'Bottled Water'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0080045', 'cui_str': 'Prices'}]",4.0,0.0673399,"FINDINGS


Prior ad exposure was positively associated with being price-responsive (OR 1.12, 95% CI 1.03, 1.22, p<0.05).","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Barnes', 'Affiliation': 'Department of Health Behavior and Policy, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Rose S', 'Initials': 'RS', 'LastName': 'Bono', 'Affiliation': 'Department of Health Behavior and Policy, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Alyssa K', 'Initials': 'AK', 'LastName': 'Rudy', 'Affiliation': 'Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Cosima', 'Initials': 'C', 'LastName': 'Hoetger', 'Affiliation': 'Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Nicksic', 'Affiliation': 'Department of Health Behavior and Policy, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Caroline O', 'Initials': 'CO', 'LastName': 'Cobb', 'Affiliation': 'Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15084']
438,31326978,Associations of Hearing Loss and Menopausal Hormone Therapy With Change in Global Cognition and Incident Cognitive Impairment Among Postmenopausal Women.,"BACKGROUND


Hearing loss (HL) and menopausal hormone therapy (conjugated equine estrogens [CEE] and/or medroxyprogesterone acetate [MPA]) are separately associated with cognitive decline and increased risk of incident cognitive impairment. Joint effects of HL and HT could be associated with additive or synergistic decline in global cognition and risk of incident cognitive impairment among postmenopausal women.
METHODS


Using the Women's Health Initiative (WHI) Memory Study, 7,220 postmenopausal women with measures of HL, global cognition (Modified Mini-Mental State Examination score), and cognitive impairment (centrally adjudicated diagnoses of mild cognitive impairment and dementia) from 1996 to 2009. Multivariable linear mixed-effects models were used to analyze rate of change in global cognition. Accelerated failure time models were used to evaluate time to incident cognitive impairment, stratified by HT.
RESULTS


Within the CEE-Alone trial, observed adverse effects of CEE-Alone on change in global cognition did not differ by HL, and estimated joint effects of HL and CEE-Alone were not associated with incident cognitive impairment. Within the CEE+MPA trial, while HL did not independently accelerate time to cognitive impairment, the adverse effect of CEE+MPA on global cognition was heightened in older women with HL. Older women on CEE+MPA either with HL (time ratio [TR] = 0.82, 95% confidence interval [CI]: 0.71, 0.94) or with normal hearing (TR = 0.86, 95% CI: 0.76, 0.97) had faster time to cognitive impairment than those with normal hearing and placebo.
CONCLUSIONS


HL may accentuate the adverse effect of CEE+MPA, not CEE-Alone, on global cognitive decline, not incident cognitive impairment, among postmenopausal women on HT.",2020,"Joint effects of HL and HT could be associated with additive or synergistic decline in global cognition and risk of incident cognitive impairment among postmenopausal women.
","['postmenopausal women', '7,220 postmenopausal women with measures of HL, global cognition (Modified Mini- Mental State Examination score), and cognitive impairment (centrally-adjudicated diagnoses of mild cognitive impairment and dementia) from 1996-2009', 'Postmenopausal Women', 'postmenopausal women on HT', 'older women with HL', 'Older women on']","['HL and HT', 'Menopausal Hormone Therapy', 'medroxyprogesterone acetate [MPA', 'CEE+MPA']","['incident cognitive impairment', 'normal hearing', 'rate of change in global cognition', 'global cognition', 'faster time to cognitive impairment']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4304091', 'cui_str': '3MS (Modified Mini-Mental State) Examination score'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0065864', 'cui_str': 'medroxyprogesterone acetate'}]","[{'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.094197,"Joint effects of HL and HT could be associated with additive or synergistic decline in global cognition and risk of incident cognitive impairment among postmenopausal women.
","[{'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Armstrong', 'Affiliation': 'Laboratory of Behavioral Neuroscience, National Institute of Aging, Baltimore, Maryland.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Jiu-Chiuan', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': 'Department of Preventive Medicine and Neurology, Keck School of Medicine of University of Southern California, Los Angeles, California.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Masaki', 'Affiliation': 'Department of Geriatric Medicine, John A. Burns School of Medicine, University of Hawai`i Manoa, Honolulu, Hawaii.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Wactawski-Wende', 'Affiliation': 'Department of Epidemiology and Environmental Health, School of Public Health and Health Professions, University of Buffalo, New York.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Medicine, University of Massachusetts Medical School, Worcester, Massachusetts.'}, {'ForeName': 'Margery L S', 'Initials': 'MLS', 'LastName': 'Gass', 'Affiliation': 'Department of Obstetrics & Gynecology, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Marcia L', 'Initials': 'ML', 'LastName': 'Stefanick', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Deal', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Rapp', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Frank R', 'Initials': 'FR', 'LastName': 'Lin', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Resnick', 'Affiliation': 'Laboratory of Behavioral Neuroscience, National Institute of Aging, Baltimore, Maryland.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz173']
439,31081862,Association of Intensive Blood Pressure Reduction With Risk of Hematoma Expansion in Patients With Deep Intracerebral Hemorrhage.,"Importance


Hypertension is the strongest risk factor for spontaneous intracerebral hemorrhage (ICH) involving deep brain regions, but it appears to be unknown if intensive blood pressure reduction in the acute care setting decreases hematoma expansion or improves outcomes in patients with deep ICH.
Objective


To determine whether intensive blood pressure reduction is associated with decreased risk of hematoma expansion and changes in 90-day modified Rankin Scale scores and if these associations are modified by the specific deep-brain nuclei involved.
Design, Setting, and Participants


This study is an exploratory analysis of the Antihypertensive Treatment of Acute Cerebral Hemorrhage-2 international, multicenter randomized clinical trial, which was conducted from May 2011 to September 2015, enrolled eligible patients with primary ICH, and followed up with them for 90 days. Patients who had ICH and complete neuroimaging data were included in the analysis. Data analysis was completed from July 2018 to December 2018.
Exposures


Participants were randomized to either intensive treatment (with a systolic blood pressure target of 110-139 mm Hg) or standard treatment (with a systolic blood pressure target of 140-179 mm Hg).
Main Outcomes and Measures


The main outcome was hematoma expansion, defined as an increase greater than 33% in hematoma volume between baseline and 24 hours. Functional outcome was evaluated 90 days after the ICH via the modified Rankin Scale.
Results


Of 1000 trial participants, 870 (87.0%) had deep ICH, of whom 780 (89.7%) had complete neuroimaging data (of 336 thalamic and 444 basal ganglia hemorrhages). The baseline characteristics of the intensive and standard treatment groups remained balanced in this subgroup of the original study. Intensive treatment was associated with a decreased risk of hematoma expansion in univariable analysis (odds ratio [OR], 0.62 [95% CI, 0.43-0.87]; P = .006) and multivariable analysis (OR, 0.61 [95% CI, 0.42-0.88]; P = .009). This association was modified by the specific deep location of the ICH (OR, 0.44 [95% CI, 0.22-0.96]; interaction P = .02), with stratified analyses showing a reduction in risk of hematoma expansion with intensive vs standard treatment among basal ganglia ICH (OR, 0.44 [95% CI, 0.27-0.72]; P = .001) but not thalamic ICH (OR, 0.91 [95% CI, 0.51-0.64]; P = .76). Intensive treatment was not associated with an improvement in the modified Rankin Scale score distribution.
Conclusions and Relevance


Compared with standard treatment, intensive blood pressure treatment was associated with reduced hematoma expansion in deep ICH, specifically among basal ganglia hemorrhages.",2019,"Intensive treatment was not associated with an improvement in the modified Rankin Scale score distribution.
","['2011 to September 2015, enrolled eligible patients with primary ICH, and followed up with them for 90 days', 'Patients who had ICH and complete neuroimaging data were included in the analysis', '1000 trial participants, 870 (87.0%) had deep ICH, of whom 780 (89.7%) had complete neuroimaging data (of 336 thalamic and 444 basal ganglia hemorrhages', 'Patients With Deep Intracerebral Hemorrhage', 'patients with deep ICH']",['intensive treatment (with a systolic blood pressure target of 110-139 mm Hg) or standard treatment (with a systolic blood pressure target of 140-179 mm Hg'],"['risk of hematoma expansion', 'hematoma volume', 'hematoma expansion', 'modified Rankin Scale score distribution', '90-day modified Rankin Scale scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0679575', 'cui_str': 'Neuroimaging'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.222201,"Intensive treatment was not associated with an improvement in the modified Rankin Scale score distribution.
","[{'ForeName': 'Audrey C', 'Initials': 'AC', 'LastName': 'Leasure', 'Affiliation': 'Department of Neurology, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Zeenat Qureshi Stroke Institute, St Cloud, Minnesota.'}, {'ForeName': 'Santosh B', 'Initials': 'SB', 'LastName': 'Murthy', 'Affiliation': 'Department of Neurology, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Kamel', 'Affiliation': 'Department of Neurology, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Joshua N', 'Initials': 'JN', 'LastName': 'Goldstein', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Woo', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Wendy C', 'Initials': 'WC', 'LastName': 'Ziai', 'Affiliation': 'Department of Neurology, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hanley', 'Affiliation': 'Department of Neurology, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Rustam', 'Initials': 'R', 'LastName': 'Al-Shahi Salman', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Matouk', 'Affiliation': 'Department of Neurosurgery, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Lauren H', 'Initials': 'LH', 'LastName': 'Sansing', 'Affiliation': 'Department of Neurology, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Kevin N', 'Initials': 'KN', 'LastName': 'Sheth', 'Affiliation': 'Department of Neurology, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Guido J', 'Initials': 'GJ', 'LastName': 'Falcone', 'Affiliation': 'Department of Neurology, Yale School of Medicine, New Haven, Connecticut.'}]",JAMA neurology,['10.1001/jamaneurol.2019.1141']
440,32191600,Countering disuse atrophy in older adults with low-volume leucine supplementation.,"Older adults are at increased risk of being bedridden and experiencing negative health outcomes including the loss of muscle tissue and functional capacity. We hypothesized that supplementing daily meals with a small quantity (3-4 g/meal) of leucine would partially preserve lean leg mass and function of older adults during bed rest. During a 7-day bed rest protocol, followed by 5 days of inpatient rehabilitation, healthy older men and women (67.8 ± 1.1 yr, 14 men; 6 women) were randomized to receive isoenergetic meals supplemented with leucine (LEU, 0.06 g/kg/meal;  n  = 10) or an alanine control (CON, 0.06 g/kg/meal;  n  = 10). Outcomes were assessed at baseline, following bed rest, and after rehabilitation. Body composition was measured by dual-energy X-ray absorptiometry. Functional capacity was assessed by knee extensor isokinetic and isometric dynamometry, peak aerobic capacity, and the short physical performance battery. Muscle fiber type, cross-sectional area, signaling protein expression levels, and single fiber characteristics were determined from biopsies of the vastus lateralis. Leucine supplementation reduced the loss of leg lean mass during bed rest (LEU vs. CON: -423 vs. -1035 ± 143 g;  P  = 0.008) but had limited impact on strength or endurance-based functional outcomes. Similarly, leucine had no effect on markers of anabolic signaling and protein degradation during bed rest or rehabilitation. In conclusion, providing older adults with supplemental leucine has minimal impact on total energy or protein consumption and has the potential to partially counter some, but not all, of the negative effects of inactivity on muscle health. NEW & NOTEWORTHY  Skeletal muscle morphology and function in older adults was significantly compromised by 7 days of disuse. Leucine supplementation partially countered the loss of lean leg mass but did not preserve muscle function or positively impact changes at the muscle fiber level associated with bed rest or rehabilitation. Of note, our data support a relationship between myonuclear content and adaptations to muscle atrophy at the whole limb and single fiber level.",2020,Leucine supplementation reduced the loss of leg lean mass during bed rest (LEU vs. CON: -423 vs. -1035 ± 143 g; p=0.008) but had limited impact on strength or endurance based functional outcomes.,"['older adults with', 'Older adults', 'older adults during bed rest', 'healthy older men and women (67.8 ± 1.1 y, 14 men; 6 women', 'older adults with low volume leucine supplementation']","['isoenergentic meals supplemented with leucine (LEU, 0.06 g/kg/meal; n=10) or an alanine control', 'supplemental leucine', 'Leucine supplementation', 'leucine']","['knee extensor isokinetic and isometric dynamometry, peak aerobic capacity and the short physical performance battery', 'Body composition', 'Muscle fiber type, cross-sectional area, signaling protein expression levels and single fiber characteristics', 'loss of leg lean mass', 'strength or endurance based functional outcomes', 'Functional capacity', 'markers of anabolic signaling and protein degradation']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}]","[{'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C4517412', 'cui_str': 'Zero point zero six'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0001898', 'cui_str': 'L-alanine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0597304', 'cui_str': 'Protein Degradation'}]",,0.049476,Leucine supplementation reduced the loss of leg lean mass during bed rest (LEU vs. CON: -423 vs. -1035 ± 143 g; p=0.008) but had limited impact on strength or endurance based functional outcomes.,"[{'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Arentson-Lantz', 'Affiliation': 'Department of Nutrition and Metabolism, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Kinga N', 'Initials': 'KN', 'LastName': 'Fiebig', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), Faculty of Health, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Kim J', 'Initials': 'KJ', 'LastName': 'Anderson-Catania', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), Faculty of Health, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Rachel R', 'Initials': 'RR', 'LastName': 'Deer', 'Affiliation': 'Center for Recovery, Physical Activity and Nutrition, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Wacher', 'Affiliation': 'Department of Anesthesiology, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Fry', 'Affiliation': 'Department of Nutrition and Metabolism, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Séverine', 'Initials': 'S', 'LastName': 'Lamon', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), Faculty of Health, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Paddon-Jones', 'Affiliation': 'Department of Nutrition and Metabolism, University of Texas Medical Branch, Galveston, Texas.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00847.2019']
441,31103018,Neural and behavioral effects of oxytocin administration during theory of mind in schizophrenia and controls: a randomized control trial.,"Social cognitive impairments, including theory of mind (ToM), in schizophrenia more strongly predict functional outcomes than psychotic symptoms or nonsocial cognitive deficits. Despite their clinical importance, current medications do not improve these deficits. The current study investigated the hypothesis that oxytocin, a neuropeptide implicated in social behavior, would normalize neural abnormalities in schizophrenia during ToM, and that this normalization would correlate improvement in ToM behavior. In this cross-over, double-blind, and placebo-controlled functional magnetic resonance imaging study, a single dose of 40 IU of oxytocin was administered via nasal spray to male individuals with a schizophrenia spectrum disorder (schizophrenia and schizoaffective disorder, n = 23) and healthy controls (n = 25). Participants completed two ToM tasks in the scanner, the False Belief and Person Description tasks. During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls. Oxytocin, relative to placebo, significantly increased accuracy and rTPJ activation for ToM but not control stories in schizophrenia. Furthermore, a significant positive correlation was found between oxytocin induced increases in rTPJ activity and accuracy, indicating that oxytocin improved rTPJ activity in schizophrenia predicted behavioral improvement. Oxytocin also significantly improved connectivity between rTPJ and mPFC in schizophrenia. These findings suggest that rTPJ activity during ToM might be a potential neural target for the treatment of social cognitive deficits in schizophrenia.",2019,"During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls.","['schizophrenia and controls', 'male\xa0individuals with a schizophrenia spectrum disorder (schizophrenia and schizoaffective disorder, n\u2009=\u200923) and healthy controls (n\u2009=\u200925']","['Oxytocin', 'placebo', 'oxytocin']","['rTPJ activity and accuracy', 'accuracy and rTPJ activation', 'Social cognitive impairments, including theory of mind (ToM', 'connectivity', 'reduced accuracy, hypo-activity', 'rTPJ activity']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}]",,0.12082,"During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls.","[{'ForeName': 'Lize', 'Initials': 'L', 'LastName': 'De Coster', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Mathalon', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Woolley', 'Affiliation': 'University of California, San Francisco, CA, USA. josh.woolley@ucsf.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0417-5']
442,32285318,Random forest for prediction of contrast-induced nephropathy following coronary angiography.,"The majority of prediction models for contrast-induced nephropathy (CIN) have moderate performance. Therefore, we aimed to develop a better pre-procedural prediction tool for CIN following contemporary percutaneous coronary intervention (PCI) or coronary angiography (CAG). A total of 3469 patients undergoing PCI/CAG between January 2010 and December 2013 were randomly divided into a training (n = 2428, 70%) and validation data-sets (n = 1041, 30%). Random forest full models were developed using 40 pre-procedural variables, of which 13 variables were selected for a reduced CIN model. CIN developed in 78 (3.21%) and 37 of patients (3.54%) in the training and validation datasets, respectively. In the validation dataset, the full and reduced models demonstrated improved discrimination over classic Mehran, ACEF CIN risk scores (AUC 0.842 and 0.825 over 0.762 and 0.701, respectively, all P < 0.05) and common estimated glomerular filtration rate. Compared to that for the Mehran risk score model, the full and reduced models had significantly improved fit based on the net reclassification improvement (all P < 0.001) and integrated discrimination improvement (P = 0.001, 0.028, respectively). Using the above models, 2462 (66.7%), 661, and 346 patients were categorized into low (< 1%), moderate (1% to 7%), and high (> 7%) risk groups, respectively. Our pre-procedural CIN risk prediction algorithm (http://cincalc.com) demonstrated good discriminative ability and was well calibrated when validated. Two-thirds of the patients were at low CIN risk, probably needing less peri-procedural preventive strategy; however, the discriminative ability of CIN risk requires further external validation. TRIAL REGISTRATION: ClinicalTrials.gov NCT01400295.",2020,"In the validation dataset, the full and reduced models demonstrated improved discrimination over classic Mehran, ACEF CIN risk scores (AUC 0.842 and 0.825 over 0.762 and 0.701, respectively, all P < 0.05) and common estimated glomerular filtration rate.",['3469 patients undergoing PCI/CAG between January 2010 and December 2013'],['percutaneous coronary intervention (PCI) or coronary angiography (CAG'],"['discrimination over classic Mehran, ACEF CIN risk scores', 'CIN']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",3469.0,0.0288732,"In the validation dataset, the full and reduced models demonstrated improved discrimination over classic Mehran, ACEF CIN risk scores (AUC 0.842 and 0.825 over 0.762 and 0.701, respectively, all P < 0.05) and common estimated glomerular filtration rate.","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Guangdong Provincial Key Laboratory of Coronary Heart Disease Prevention, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, South China University of Technology, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Shiqun', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Guangdong Provincial Key Laboratory of Coronary Heart Disease Prevention, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, South China University of Technology, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Cardiology&Dongguan Division of Guangdong Provincial Key Laboratory of Coronary Heart Disease Prevention, Dongguan TCM Hospital, Dongguan, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xian', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Xuan', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Tan', 'Affiliation': ""Department of Cardiology, Guangdong Provincial Key Laboratory of Coronary Heart Disease Prevention, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, South China University of Technology, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Jiyan', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Guangdong Provincial Key Laboratory of Coronary Heart Disease Prevention, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, South China University of Technology, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China. chenjiyandr@126.com.""}, {'ForeName': 'Zhonghan', 'Initials': 'Z', 'LastName': 'Ni', 'Affiliation': ""Department of Cardiology, Guangdong Provincial Key Laboratory of Coronary Heart Disease Prevention, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, South China University of Technology, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China. liuyongxueshu@139.com.""}]",The international journal of cardiovascular imaging,['10.1007/s10554-019-01730-6']
443,32078469,Effect of acetazolamide on susceptibility to central sleep apnea in chronic spinal cord injury.,"Spinal cord injury (SCI) is an established risk factor for central sleep apnea. Acetazolamide (ACZ), a carbonic anhydrase inhibitor, has been shown to decrease the frequency of central apnea by inducing mild metabolic acidosis. We hypothesized that ACZ would decrease the propensity to develop hypocapnic central apnea and decrease the apneic threshold. We randomized 16 participants with sleep-disordered breathing (8 SCI and 8 able-bodied controls) to receive ACZ (500 mg twice a day for 3 days) or placebo with a 1-wk washout before crossing over to the other drug arm. Study nights included polysomnography and determination of the hypocapnic apneic threshold and CO 2  reserve using noninvasive ventilation. For participants with spontaneous central apnea, CO 2  was administered until central apnea was abolished, and CO 2  reserve was measured as the difference in end-tidal Pco 2  ( P E T C O 2 ) before and after. Steady-state plant gain, the response of end-tidal Pco 2  to changes in ventilation, was calculated from  P E T C O 2  and V̇e ratio during stable sleep. Controller gain, the response of ventilatory drive to changes in end-tidal Pco 2 , was defined as the ratio of change in V̇e between control and hypopnea to the ΔCO 2  during stable non-rapid eye movement sleep. Treatment with ACZ for three days resulted in widening of the CO 2  reserve (-4.0 ± 1.2 vs. -3.0 ± 0.7 mmHg for able-bodied, -3.4 ± 1.9 vs. -2.2 ± 2.2 mmHg for SCI,  P  < 0.0001), and a corresponding decrease in the hypocapnic apnea threshold (28.3 ± 5.2 vs. 37.1 ± 5.6 mmHg for able-bodied, 29.9 ± 5.4 vs. 34.8 ± 6.9 mmHg for SCI,  P  < 0.0001), respectively. ACZ significantly reduced plant gain when compared with placebo (4.1 ± 1.7 vs. 5.4 ± 1.8 mmHg/L min for able-bodied, 4.1 ± 2.0 vs. 5.1 ± 1.7 mmHg·L -1 ·min for SCI,  P  < 0.01). Acetazolamide decreased apnea-hypopnea index (28.8 ± 22.9 vs. 39.3 ± 24.1 events/h;  P  = 0.05), central apnea index (0.6 ± 1.5 vs. 6.3 ± 13.1 events/h;  P  = 0.05), and oxyhemoglobin desaturation index (7.5 ± 8.3 vs. 19.2 ± 15.2 events/h;  P  = 0.01) compared with placebo. Our results suggest that treatment with ACZ decreases susceptibility to hypocapnic central apnea due to decreased plant gain. Acetazolamide may attenuate central sleep apnea and improve nocturnal oxygen saturation, but its clinical utility requires further investigation in a larger sample of patients. NEW & NOTEWORTHY  Tetraplegia is a risk factor for central sleep-disordered breathing (SDB) and is associated with narrow CO 2  reserve (a marker of susceptibility to central apnea). Treatment with high-dose acetazolamide for 3 days decreased susceptibility to hypocapnic central apnea and reduced the frequency of central respiratory events during sleep. Acetazolamide may play a therapeutic role in alleviating central SDB in patients with cervical spinal cord injury, but larger clinical trials are needed.",2020,"ACZ significantly reduced PG when compared to placebo (4.1±1.7 vs 5.4±1.8 mmHg L -1  min for able-bodied, 4.1±2.0 vs 5.1±1.7 mmHg L -1  min for SCI, p<0.01).","['chronic spinal cord injury', '16 participants with sleep-disordered breathing (8 SCI, 8 able-bodied controls) to receive']","['placebo', 'acetazolamide', 'Acetazolamide', 'ACZ', 'Acetazolamide (ACZ']","['central sleep apnea', 'CO 2  reserve', 'oxyhemoglobin desaturation index', 'Steady-state plant gain (PG', 'apnea-hypopnea index', 'PG', 'central apnea index']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0000981', 'cui_str': 'Acetazolamide'}]","[{'cui': 'C3887547', 'cui_str': 'Central sleep apnea syndrome (disorder)'}, {'cui': 'C1168591', 'cui_str': 'Oxyhaemoglobin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032098', 'cui_str': 'Plants'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0520680', 'cui_str': 'Ondine Syndrome'}]",16.0,0.0364772,"ACZ significantly reduced PG when compared to placebo (4.1±1.7 vs 5.4±1.8 mmHg L -1  min for able-bodied, 4.1±2.0 vs 5.1±1.7 mmHg L -1  min for SCI, p<0.01).","[{'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Ginter', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'Abdulghani', 'Initials': 'A', 'LastName': 'Sankari', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Eshraghi', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Obiakor', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Yarandi', 'Affiliation': 'Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Susmita', 'Initials': 'S', 'LastName': 'Chowdhuri', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'Anan', 'Initials': 'A', 'LastName': 'Salloum', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'M Safwan', 'Initials': 'MS', 'LastName': 'Badr', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center, Detroit, Michigan.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00532.2019']
444,32279690,Resistant starch supplementation increases crypt cell proliferative state in the rectal mucosa of older healthy participants.,"There is strong evidence that foods containing dietary fibre protect against colorectal cancer, resulting at least in part from its anti-proliferative properties. This study aimed to investigate the effects of supplementation with two non-digestible carbohydrates, resistant starch (RS) and polydextrose (PD), on crypt cell proliferative state (CCPS) in the macroscopically normal rectal mucosa of healthy individuals. We also investigated relationships between expression of regulators of apoptosis and of the cell cycle on markers of CCPS. Seventy-five healthy participants were supplemented with RS and/or PD or placebo for 50 d in a 2 × 2 factorial design in a randomised, double-blind, placebo-controlled trial (the Dietary Intervention, Stem cells and Colorectal Cancer (DISC) Study). CCPS was assessed, and the expression of regulators of the cell cycle and of apoptosis was measured by quantitative PCR in rectal mucosal biopsies. SCFA concentrations were quantified in faecal samples collected pre- and post-intervention. Supplementation with RS increased the total number of mitotic cells within the crypt by 60 % (P = 0·001) compared with placebo. This effect was limited to older participants (aged ≥50 years). No other differences were observed for the treatments with PD or RS as compared with their respective controls. PD did not influence any of the measured variables. RS, however, increased cell proliferation in the crypts of the macroscopically-normal rectum of older adults. Our findings suggest that the effects of RS on CCPS are not only dose, type of RS and health status-specific but are also influenced by age.",2020,Supplementation with RS increased the total number of mitotic cells within the crypt by 60% (p=0.001) compared with placebo.,"['75 healthy participants', 'older participants (aged ≥50', 'older healthy participants', 'macroscopically-normal rectal mucosa of healthy individuals']","['RS and/or PD or placebo', 'supplementation with two non-digestible carbohydrates, resistant starch (RS) and polydextrose (PD', 'Resistant starch supplementation', 'placebo']","['expression of regulators of the cell cycle and of apoptosis', 'SCFA concentrations', 'total number of mitotic cells', 'crypt cell proliferative state (CCPS', 'cell proliferation', 'crypt cell proliferative state']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0227395', 'cui_str': 'Rectal mucous membrane structure'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0071545', 'cui_str': 'polydextrose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0230518', 'cui_str': 'Mitotic cell'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0596290', 'cui_str': 'Cellular Proliferation'}]",75.0,0.290488,Supplementation with RS increased the total number of mitotic cells within the crypt by 60% (p=0.001) compared with placebo.,"[{'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Malcomson', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle upon TyneNE2 4HH, UK.'}, {'ForeName': 'Naomi D', 'Initials': 'ND', 'LastName': 'Willis', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle upon TyneNE2 4HH, UK.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'McCallum', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North ShieldsNE29 8NH, UK.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle upon TyneNE2 4HH, UK.'}, {'ForeName': 'Arthur C', 'Initials': 'AC', 'LastName': 'Ouwehand', 'Affiliation': 'DuPont Nutrition & Biosciences, 02460Kantvik, Finland.'}, {'ForeName': 'Julian D', 'Initials': 'JD', 'LastName': 'Stowell', 'Affiliation': 'DuPont Nutrition & Biosciences, ReigateRH2 9PQ, UK.'}, {'ForeName': 'Seamus', 'Initials': 'S', 'LastName': 'Kelly', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North ShieldsNE29 8NH, UK.'}, {'ForeName': 'D Michael', 'Initials': 'DM', 'LastName': 'Bradburn', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, AshingtonNE63 9JJ, UK.'}, {'ForeName': 'Nigel J', 'Initials': 'NJ', 'LastName': 'Belshaw', 'Affiliation': 'University of East Anglia, Norwich Research Park, NorwichNR4 7TJ, UK.'}, {'ForeName': 'Ian T', 'Initials': 'IT', 'LastName': 'Johnson', 'Affiliation': 'Quadram Institute, Norwich Research Park, NorwichNR4 7UQ, UK.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Mathers', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle upon TyneNE2 4HH, UK.'}]",The British journal of nutrition,['10.1017/S0007114520001312']
445,32279841,Bioresorbable Vascular Scaffolds Versus Drug-Eluting Stents for Diffuse Long Coronary Narrowings.,"Clinical benefits of bioresorbable vascular scaffold (BVS) implantation for long coronary lesions were not sufficiently evaluated. The efficacy and safety of BVS and metallic everolimus-eluting stent (EES) were compared for the treatment of long coronary narrowings. A total of 341 patients with diffuse long lesions (requiring device length ≥28 mm) were randomized to receive either BVS (n = 171) or EES (n = 170) implantation. The primary endpoint was major adverse cardiovascular events which included death from cardiac cause, myocardial infarction, device thrombosis, or ischemia-driven target-lesion revascularization at 12 months. The trial was terminated early because the manufacturer stopped supplying BVS. The mean lesion length was 32.2 ± 13.1 mm in the BVS group and 35.3 ± 13.0 mm in the EES group. The 12-month follow-up was completed in 332 patients (97.4%). At 12 months, the primary endpoint events occurred in 2 patients (1.2%) in the BVS group and in 4 patients (2.4%) in the EES group (hazard ratio = 0.49, 95% confidence interval = 0.09 to 2.67, p = 0.398). Definite or probable device thrombosis occurred in 1 patient (0.6%) in the BVS group and 1 patient (0.6%) in the EES group (hazard ratio = 1.00, 95% confidence interval = 0.06 to 15.94, p = 0.998). In conclusion, in patients with long native coronary artery disease, significant differences between BVS and EES were not observed regarding the primary composite endpoint of death from cardiac cause, myocardial infarction, device thrombosis, or target-lesion revascularization at 12 months. However, due to the early termination of this trial and a low number of events, the results cannot be considered clinically relevant (clinicalTrials.gov Identifier: NCT02796157).",2020,"The primary endpoint was major adverse cardiovascular events which included death from cardiac cause, myocardial infarction, device thrombosis, or ischemia-driven target-lesion revascularization at 12 months.","['341 patients with diffuse long lesions (requiring device length ≥28 mm', 'Diffuse Long Coronary Narrowings', 'patients with long native coronary artery disease']","['BVS', 'BVS and metallic everolimus-eluting stent (EES', 'bioresorbable vascular scaffold (BVS) implantation', 'Bioresorbable Vascular Scaffolds Versus Drug-Eluting Stents', 'EES']","['BVS and EES', 'death from cardiac cause, myocardial infarction, device thrombosis, or target-lesion revascularization', 'mean lesion length', 'Definite or probable device thrombosis', 'major adverse cardiovascular events which included death from cardiac cause, myocardial infarction, device thrombosis, or ischemia-driven target-lesion revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]",341.0,0.119129,"The primary endpoint was major adverse cardiovascular events which included death from cardiac cause, myocardial infarction, device thrombosis, or ischemia-driven target-lesion revascularization at 12 months.","[{'ForeName': 'Jongkwon', 'Initials': 'J', 'LastName': 'Seo', 'Affiliation': 'Sanggye Paik Hospital, Inje University, Seoul, Korea.'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Ahn', 'Affiliation': 'Heart Institute, Asan Medical Center, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Sung-Jin', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Do-Yoon', 'Initials': 'DY', 'LastName': 'Kang', 'Affiliation': 'Heart Institute, Asan Medical Center, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Soon Jun', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Cardiac Center, Korea University Anam Hospital, Seoul, Korea.'}, {'ForeName': 'Ae-Young', 'Initials': 'AY', 'LastName': 'Her', 'Affiliation': 'Kangwon National University School of Medicine, Chuncheon, Korea.'}, {'ForeName': 'Yong Hoon', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Kangwon National University School of Medicine, Chuncheon, Korea.'}, {'ForeName': 'Chul-Min', 'Initials': 'CM', 'LastName': 'Ahn', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Jung-Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Byeong-Keuk', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Young-Guk', 'Initials': 'YG', 'LastName': 'Ko', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Yangsoo', 'Initials': 'Y', 'LastName': 'Jang', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Seung-Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Heart Institute, Asan Medical Center, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Duk-Woo', 'Initials': 'DW', 'LastName': 'Park', 'Affiliation': 'Heart Institute, Asan Medical Center, University of Ulsan, Seoul, Korea. Electronic address: dwpark@amc.seoul.kr.'}, {'ForeName': 'Myeong-Ki', 'Initials': 'MK', 'LastName': 'Hong', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea. Electronic address: mkhong61@yuhs.ac.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.02.031']
446,32044802,Subomohyoid Anterior Suprascapular Block versus Interscalene Block for Arthroscopic Shoulder Surgery: A Multicenter Randomized Trial.,"BACKGROUND


Interscalene brachial plexus block, the pain relief standard for shoulder surgery, is an invasive technique associated with important complications. The subomohyoid anterior suprascapular block is a potential alternative, but evidence of its comparative analgesic effect is sparse. The authors tested the hypothesis that anterior suprascapular block is noninferior to interscalene block for improving pain control after shoulder surgery. As a secondary objective, the authors evaluated the success of superior trunk (C5-C6 dermatomes) block with suprascapular block.
METHODS


In this multicenter double-blind noninferiority randomized trial, 140 patients undergoing shoulder surgery were randomized to either interscalene or anterior suprascapular block with 15 ml of ropivacaine 0.5% and epinephrine. The primary outcome was area under the curve of postoperative visual analog scale pain scores during the first 24 h postoperatively. The 90% CI for the difference (interscalene-suprascapular) was compared against a -4.4-U noninferiority margin. Secondary outcomes included presence of superior trunk blockade, pain scores at individual time points, opioid consumption, time to first analgesic request, opioid-related side-effects, and quality of recovery.
RESULTS


A total of 136 patients were included in the analysis. The mean difference (90% CI) in area under the curve of pain scores for the (interscalene-suprascapular) comparison was -0.3 U (-0.8 to 0.12), exceeding the noninferiority margin of -4.4 U and demonstrating noninferiority of suprascapular block. The risk ratio (95% CI) of combined superior trunk (C5-C6 dermatomes) blockade was 0.98 (0.92 to 1.01), excluding any meaningful difference in superior trunk block success rates between the two groups. When differences in other analgesic outcomes existed, they were not clinically important.
CONCLUSIONS


The suprascapular block was noninferior to interscalene block with respect to improvement of postoperative pain control, and also for blockade of the superior trunk. These findings suggest that the suprascapular block consistently blocks the superior trunk and qualify it as an effective interscalene block alternative.",2020,"The suprascapular block was noninferior to interscalene block with respect to improvement of postoperative pain control, and also for blockade of the superior trunk.","['Arthroscopic Shoulder Surgery', '140 patients undergoing shoulder surgery', 'A total of 136 patients were included in the analysis']","['Subomohyoid Anterior Suprascapular Block versus Interscalene Block', 'interscalene or anterior suprascapular block with 15 ml of ropivacaine 0.5% and epinephrine']","['superior trunk block success rates', 'presence of superior trunk blockade, pain scores at individual time points, opioid consumption, time to first analgesic request, opioid-related side-effects, and quality of recovery', 'area under the curve of postoperative visual analog scale pain scores', 'pain scores', 'risk ratio']","[{'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach (procedure)'}, {'cui': 'C0589495', 'cui_str': 'Interscalene approach (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",140.0,0.219577,"The suprascapular block was noninferior to interscalene block with respect to improvement of postoperative pain control, and also for blockade of the superior trunk.","[{'ForeName': 'Faraj W', 'Initials': 'FW', 'LastName': 'Abdallah', 'Affiliation': ""From the Department of Anesthesiology and Pain Medicine, and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Canada (F.W.A.) the Department of Anesthesia (F.W.A., D.N.W., R.B., A.M., V.W.S.C.) the Institute of Health Policy, Management, and Evaluation (D.N.W., A.L.) the Department of Medicine (A.L.) the Dalla Lana School of Public Health (K.E.T.), University of Toronto, Toronto, Canada the Li Ka Shing Knowledge Institute of St. Michael's Hospital, University of Toronto, Toronto, Canada (F.W.A., D.N.W., A.L.) the Department of Anesthesia (D.N.W.) the Department of Medicine (A.L.), St. Michael's Hospital, Toronto, Canada the Department of Anesthesia and Pain Management, University Health Network, Toronto, Canada (D.N.W., V.W.S.C.) the Department of Anesthesia, Women's College Hospital, Toronto, Canada (R.B.) the Department of Anesthesia, North York General Hospital, Toronto, Canada (A.M.) the Department of Anesthesia, Wexner Medical Center, Ohio State University, Columbus, Ohio (N.H.) the Applied Health Research Centre, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Canada (K.E.T.).""}, {'ForeName': 'Duminda N', 'Initials': 'DN', 'LastName': 'Wijeysundera', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Laupacis', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Brull', 'Affiliation': ''}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Mocon', 'Affiliation': ''}, {'ForeName': 'Nasir', 'Initials': 'N', 'LastName': 'Hussain', 'Affiliation': ''}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': ''}, {'ForeName': 'Vincent W S', 'Initials': 'VWS', 'LastName': 'Chan', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003132']
447,32265346,Subomohyoid Anterior Suprascapular Block versus Interscalene Block for Arthroscopic Shoulder Surgery: A Multicenter Randomized Trial: Erratum.,,2020,,['Arthroscopic Shoulder Surgery'],['Subomohyoid Anterior Suprascapular Block versus Interscalene Block'],[],"[{'cui': 'C0186321', 'cui_str': 'Operative procedure on shoulder'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}]",[],,0.0942267,,[],Anesthesiology,['10.1097/ALN.0000000000003314']
448,31677583,Ethnicity and health outcomes among people with epilepsy participating in an epilepsy self-management RCT.,"People with epilepsy (PWE) may experience negative health events (NHEs) such as seizures, emergency room visits, and hospitalizations, with ethnic and racial minorities disproportionately affected. Epilepsy self-management may reduce NHEs; however, few reports examine self-management outcomes in racial minorities. Using data from a longitudinal 6-month randomized controlled trial (RCT) of 120 PWE, this analysis compared African-American and Whites at baseline, 10 weeks and 24 weeks after receiving the ""Self-management for people with epilepsy (SMART) and a history of NHEs"" self-management program. The primary RCT outcome was number of NHEs. At baseline, compared to Whites, African-Americans had less education (p = 0.02) and greater depressive severity (p = 0.04). Both African-American and Whites generally improved with SMART, and there were no racial differences in NHE counts or other outcomes' responses. Given known racial disparities in epilepsy care, it may be particularly important to reach out to minority PWE with self-management programs.",2019,"Both African-American and Whites generally improved with SMART, and there were no racial differences in NHE counts or other outcomes' responses.","['African-American and Whites at baseline, 10\u202fweeks and 24\u202fweeks after receiving the ""Self-management for people with epilepsy (SMART) and a history of NHEs"" self-management program', 'People with epilepsy (PWE', 'people with epilepsy participating in an epilepsy self-management RCT']",[],"['number of NHEs', 'Ethnicity and health outcomes', 'depressive severity']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0414492,"Both African-American and Whites generally improved with SMART, and there were no racial differences in NHE counts or other outcomes' responses.","[{'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': 'Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Aebi', 'Affiliation': 'Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Lu', 'Affiliation': 'Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Burant', 'Affiliation': 'Case Western Reserve University, Frances Payne Bolton School of Nursing, Cleveland, Ohio, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Sajatovic', 'Affiliation': 'Department of Psychiatry and of Neurology, Neurological & Behavioral Outcomes Center, Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA. Electronic address: Martha.Sajatovic@uhhospitals.org.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2019.106469']
449,30822774,"Randomized, double-blind, placebo-controlled study of F17464, a preferential D 3  antagonist, in the treatment of acute exacerbation of schizophrenia.","F17464, a highly potent preferential D3 antagonist, is a novel compound in development for schizophrenia treatment. This phase II, double-blind, randomized, placebo-controlled, parallel-group study in five European countries evaluated the efficacy and safety of F17464, 20 mg twice daily, versus placebo over 6 weeks in patients with acute exacerbation of schizophrenia. Change from baseline to Day 43 of the Positive and Negative Syndrome Scale (PANSS) total score was the primary outcome. The data from 134 randomized patients (67 per group) were analyzed (efficacy/safety). Using analysis of covariance (ANCOVA) after last observation carried forward (LOCF) imputation (primary analysis), the PANSS total score reduction was statistically significantly greater for F17464 than placebo treated subjects at endpoint (p = 0.014); using ANCOVA with Multiple Imputation (MI) method, the between-group difference was in favor of F17464 but did not reach statistical significance. Differences in PANSS positive and general psychopathology subscale score, Marder positive factor score, PANSS response, and PANSS resolution criteria were also statistically significant in favor of F17464 (p values < 0.05) using the LOCF method, with similar results as for the primary analysis using the MI method. Treatment-related adverse events (AEs) were reported in 49.3% and 46.3% of patients on F17464 and placebo, respectively. The most common AEs in F17464 group: insomnia, agitation, and increased triglycerides; worsening of schizophrenia/drug ineffective was less frequent in F17464. Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464. This 6-week trial demonstrated therapeutic efficacy of 40 mg/day F17464 in improving symptoms of acute exacerbation of schizophrenia with a favorable safety profile.",2019,"Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464.","['acute exacerbation of schizophrenia', 'patients with acute exacerbation of schizophrenia']",['placebo'],"['weight gain, no extrapyramidal disorder except rare akathisia', 'insomnia, agitation, and increased triglycerides; worsening of schizophrenia/drug ineffective', 'PANSS positive and general psychopathology subscale score, Marder positive factor score, PANSS response, and PANSS resolution criteria', 'adverse events (AEs', 'PANSS total score reduction', 'therapeutic efficacy', 'Positive and Negative Syndrome Scale (PANSS) total score']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0015371', 'cui_str': 'Extrapyramidal Disorders'}, {'cui': 'C0522498', 'cui_str': 'Uncommon (qualifier value)'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0852908', 'cui_str': 'Drug ineffective'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}]",134.0,0.307203,"Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464.","[{'ForeName': 'Istvan', 'Initials': 'I', 'LastName': 'Bitter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Semmelweis University, Balassa u.6, Budapest, 1083, Hungary.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'New York Presbyterian Hospital - Columbia University Medical Center, 1051 Riverside Drive, New York, NY, 10032, USA.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Gaudoux', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Sokoloff', 'Affiliation': 'PSAdvice, Impasse Larosa, Ile-aux-Moines, 56780, France.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Groc', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Chavda', 'Affiliation': ""Galderma, Rue D'Entre-deux-Villes 10, La Tour de Peilz, 1814, Switzerland.""}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Delsol', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Barthe', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Brunner', 'Affiliation': 'IRIS Servier, 50 rue Carot, Suresnes Cedex, 92284, France.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Fabre', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Fagard', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Montagne', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Tonner', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France. francoise.tonner@pierre-fabre.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0355-2']
450,32151708,Changes in serum estrogenic activity during neoadjuvant therapy with letrozole and exemestane.,"The aromatase inhibitors (AIs), letrozole (Femar®/Femara®) and exemestane (Aromasin®), are widely used to treat estrogen receptor (ER) positive breast cancer in postmenopausal patients. In the setting of metastatic breast cancer, these drugs may be used after another causing new responses in selected patients after progressing on the first choice. The precise explanation for this ""lack of cross resistance"" is still missing. NEOLETEXE is a neoadjuvant, randomized, open-label, cross-over trial. Postmenopausal patients with ER-positive, HER-2 negative, locally advanced breast cancer were enrolled. All patients were randomized to treatment starting with either letrozole or exemestane for at least 2 months followed by another 2 months on the alternative AI. The total estrogenic activities in blood samples were determined using the AroER tri-screen assay developed in the Chen laboratory. Using this highly sensitive assay, estrogenic activity was detected at three time points for all patients. Importantly, a significantly higher total estrogenic activity was found during therapy with exemestane compared to letrozole in 21 out of 26 patients. When letrozole was included in the AroER tri-screen assay, the estrogenic activities in most samples collected during exemestane treatment were further reduced, suggesting that low levels of androgens remained in specimens obtained after exemestane treatment. Our results suggest the AroER tri-screen to be a very sensitive method to estimate the overall estrogen-mediated activity in human samples even during therapy with highly potent aromatase inhibitors. In the present study, serum estrogen activity was significantly higher during exemestane therapy when compared to letrozole therapy.",2020,"In the present study, serum estrogen activity was significantly higher during exemestane therapy when compared to letrozole therapy.","['postmenopausal patients', 'Postmenopausal patients with ER-positive, HER-2 negative, locally advanced breast cancer were enrolled']","['letrozole', 'letrozole and exemestane', 'aromatase inhibitors (AIs), letrozole (Femar®/Femara®) and exemestane (Aromasin®', 'letrozole or exemestane', 'exemestane']","['total estrogenic activities in blood samples', 'serum estrogenic activity', 'estrogenic activity', 'serum estrogen activity', 'total estrogenic activity', 'estrogenic activities']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C3495949', 'cui_str': 'Locally advanced breast cancer'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C0876723', 'cui_str': 'Aromasin'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0857965', 'cui_str': 'Serum oestrogen'}]",26.0,0.0127101,"In the present study, serum estrogen activity was significantly higher during exemestane therapy when compared to letrozole therapy.","[{'ForeName': 'Nazli', 'Initials': 'N', 'LastName': 'Bahrami', 'Affiliation': 'Department of Oncology, Akershus University Hospital (AHUS), Lørenskog, Norway; Department of Breast and Endocrine Surgery, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Chang', 'Affiliation': 'Department of Cancer Biology, Beckman Research Institute of the City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Kanaya', 'Affiliation': 'Department of Cancer Biology, Beckman Research Institute of the City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Torill', 'Initials': 'T', 'LastName': 'Sauer', 'Affiliation': 'Department of Pathology, Akershus University Hospital, Lørenskog, Norway; Institute of Clinical Medicine, University of Oslo, Campus AHUS, Norway.'}, {'ForeName': 'Daehoon', 'Initials': 'D', 'LastName': 'Park', 'Affiliation': 'Department of Pathology, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Loeng', 'Affiliation': 'Department of Oncology, Akershus University Hospital (AHUS), Lørenskog, Norway.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Gravdehaug', 'Affiliation': 'Department of Breast and Endocrine Surgery, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Shiuan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Cancer Biology, Beckman Research Institute of the City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Geisler', 'Affiliation': 'Department of Oncology, Akershus University Hospital (AHUS), Lørenskog, Norway; Institute of Clinical Medicine, University of Oslo, Campus AHUS, Norway. Electronic address: juergen.geisler@medisin.uio.no.'}]",The Journal of steroid biochemistry and molecular biology,['10.1016/j.jsbmb.2020.105641']
451,32271377,Durvalumab With or Without Tremelimumab vs Standard Chemotherapy in First-line Treatment of Metastatic Non-Small Cell Lung Cancer: The MYSTIC Phase 3 Randomized Clinical Trial.,"Importance


Checkpoint inhibitors targeting programmed cell death 1 or its ligand (PD-L1) as monotherapies or in combination with anti-cytotoxic T-lymphocyte-associated antigen 4 have shown clinical activity in patients with metastatic non-small cell lung cancer.
Objective


To compare durvalumab, with or without tremelimumab, with chemotherapy as a first-line treatment for patients with metastatic non-small cell lung cancer.
Design, Setting, and Participants


This open-label, phase 3 randomized clinical trial (MYSTIC) was conducted at 203 cancer treatment centers in 17 countries. Patients with treatment-naive, metastatic non-small cell lung cancer who had no sensitizing EGFR or ALK genetic alterations were randomized to receive treatment with durvalumab, durvalumab plus tremelimumab, or chemotherapy. Data were collected from July 21, 2015, to October 30, 2018.
Interventions


Patients were randomized (1:1:1) to receive treatment with durvalumab (20 mg/kg every 4 weeks), durvalumab (20 mg/kg every 4 weeks) plus tremelimumab (1 mg/kg every 4 weeks, up to 4 doses), or platinum-based doublet chemotherapy.
Main Outcomes and Measures


The primary end points, assessed in patients with ≥25% of tumor cells expressing PD-L1, were overall survival (OS) for durvalumab vs chemotherapy, and OS and progression-free survival (PFS) for durvalumab plus tremelimumab vs chemotherapy. Analysis of blood tumor mutational burden (bTMB) was exploratory.
Results


Between July 21, 2015, and June 8, 2016, 1118 patients were randomized. Baseline demographic and disease characteristics were balanced between treatment groups. Among 488 patients with ≥25% of tumor cells expressing PD-L1, median OS was 16.3 months (95% CI, 12.2-20.8) with durvalumab vs 12.9 months (95% CI, 10.5-15.0) with chemotherapy (hazard ratio [HR], 0.76; 97.54% CI, 0.56-1.02; P = .04 [nonsignificant]). Median OS was 11.9 months (95% CI, 9.0-17.7) with durvalumab plus tremelimumab (HR vs chemotherapy, 0.85; 98.77% CI, 0.61-1.17; P = .20). Median PFS was 3.9 months (95% CI, 2.8-5.0) with durvalumab plus tremelimumab vs 5.4 months (95% CI, 4.6-5.8) with chemotherapy (HR, 1.05; 99.5% CI, 0.72-1.53; P = .71). Among 809 patients with evaluable bTMB, those with a bTMB ≥20 mutations per megabase showed improved OS for durvalumab plus tremelimumab vs chemotherapy (median OS, 21.9 months [95% CI, 11.4-32.8] vs 10.0 months [95% CI, 8.1-11.7]; HR, 0.49; 95% CI, 0.32-0.74). Treatment-related adverse events of grade 3 or higher occurred in 55 (14.9%) of 369 patients who received treatment with durvalumab, 85 (22.9%) of 371 patients who received treatment with durvalumab plus tremelimumab, and 119 (33.8%) of 352 patients who received treatment with chemotherapy. These adverse events led to death in 2 (0.5%), 6 (1.6%), and 3 (0.9%) patients, respectively.
Conclusions and Relevance


The phase 3 MYSTIC study did not meet its primary end points of improved OS with durvalumab vs chemotherapy or improved OS or PFS with durvalumab plus tremelimumab vs chemotherapy in patients with ≥25% of tumor cells expressing PD-L1. Exploratory analyses identified a bTMB threshold of ≥20 mutations per megabase for optimal OS benefit with durvalumab plus tremelimumab.
Trial Registration


ClinicalT rials.gov Identifier: NCT02453282.",2020,"Treatment-related adverse events of grade 3 or higher occurred in 55 (14.9%) of 369 patients who received treatment with durvalumab, 85 (22.9%) of 371 patients who received treatment with durvalumab plus tremelimumab, and 119 (33.8%) of 352 patients who received treatment with chemotherapy.","['Patients with treatment-naive, metastatic non-small cell lung cancer who had no sensitizing EGFR or ALK genetic alterations', '369 patients who received treatment with durvalumab, 85 (22.9%) of 371 patients who received treatment with durvalumab plus tremelimumab, and 119 (33.8%) of 352 patients who received treatment with', '1118 patients were randomized', '203 cancer treatment centers in 17 countries', 'Metastatic Non-Small Cell Lung Cancer', '488 patients with ≥25% of', '809 patients with evaluable bTMB', 'Data were collected from July 21, 2015, to October 30, 2018', 'patients with metastatic non-small cell lung cancer']","['Durvalumab With or Without Tremelimumab vs Standard Chemotherapy', 'durvalumab, with or without tremelimumab, with chemotherapy', 'chemotherapy', 'durvalumab, durvalumab plus tremelimumab, or chemotherapy', 'durvalumab vs chemotherapy', 'tremelimumab', 'durvalumab', 'platinum-based doublet chemotherapy']","['blood tumor mutational burden (bTMB', 'overall survival (OS) for durvalumab vs chemotherapy, and OS and progression-free survival (PFS', 'tumor cells expressing PD-L1, median OS', 'Median PFS', 'Median OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",1118.0,0.235187,"Treatment-related adverse events of grade 3 or higher occurred in 55 (14.9%) of 369 patients who received treatment with durvalumab, 85 (22.9%) of 371 patients who received treatment with durvalumab plus tremelimumab, and 119 (33.8%) of 352 patients who received treatment with chemotherapy.","[{'ForeName': 'Naiyer A', 'Initials': 'NA', 'LastName': 'Rizvi', 'Affiliation': 'Division of Hematology/Oncology, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Byoung Chul', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Reinmuth', 'Affiliation': 'Asklepios Lung Clinic, Munich-Gauting, Germany.'}, {'ForeName': 'Ki Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, South Korea.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Luft', 'Affiliation': 'Department of Oncology No. 1 (Thoracic Surgery), Leningrad Regional Clinical Hospital, St Petersburg, Russia.'}, {'ForeName': 'Myung-Ju', 'Initials': 'MJ', 'LastName': 'Ahn', 'Affiliation': 'Department of Hematology and Oncology, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Michel M', 'Initials': 'MM', 'LastName': 'van den Heuvel', 'Affiliation': 'Nederlands Kanker Instituut-Antoni van Leeuwenhoekziekenhuis, Amsterdam, the Netherlands.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Cobo', 'Affiliation': 'Hospital Regional Universitario de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Alexey', 'Initials': 'A', 'LastName': 'Smolin', 'Affiliation': 'Department of Radiology, Burdenko Main Military Clinical Hospital, Moscow, Russia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Moiseyenko', 'Affiliation': 'Oncological Clinical Research Center, St Petersburg, Russia.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Antonia', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.'}, {'ForeName': 'Sylvestre', 'Initials': 'S', 'LastName': 'Le Moulec', 'Affiliation': 'Department of Medical Oncology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Robinet', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier Régional Universitaire de Brest-Hôpital Morvan, Brest, France.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Natale', 'Affiliation': 'Cedars-Sinai Comprehensive Cancer Center, Los Angeles, California.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'Department of Hematology and Oncology, NYU Winthrop Hospital, Mineola, New York.'}, {'ForeName': 'Frances A', 'Initials': 'FA', 'LastName': 'Shepherd', 'Affiliation': 'Princess Margaret Cancer Centre and the Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sarayut Lucien', 'Initials': 'SL', 'LastName': 'Geater', 'Affiliation': 'Department of Internal Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Garon', 'Affiliation': 'David Geffen School of Medicine, University of California/TRIO-US Network, Los Angeles.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Kim', 'Affiliation': 'Levine Cancer Institute, Atrium Health, Charlotte, North Carolina.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Goldberg', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, Connecticut.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Faculty of Medicine, Department of Medical Oncology, Kindai University, Osaka, Japan.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Raja', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Brandon W', 'Initials': 'BW', 'LastName': 'Higgs', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Boothman', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Luping', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'Scheuring', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Stockman', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Vikram K', 'Initials': 'VK', 'LastName': 'Chand', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA oncology,['10.1001/jamaoncol.2020.0237']
452,32278783,"Re-evaluation of the Uplift Clinical Trial, Using Age-Appropriate Spirometric Criteria.","BACKGROUND


The clinical trial of tiotropium in COPD, UPLIFT, enrolled adults with a mean age of 65 years and moderate-to-severe airflow obstruction, based on criteria from the Global Initiative for Chronic Obstructive Lung Disease (GOLD). For the UPLIFT cohort, however, GOLD-based criteria are not age-appropriate.
RESEARCH QUESTION


Will the use of more age-appropriate criteria for airflow obstruction from the Global Lung Function Initiative (GLI) modify the spirometric classification of the UPLIFT cohort and, in turn, the mortality effect of tiotropium in COPD?
STUDY DESIGN AND METHODS


Baseline spirometric classifications were first cross-tabulated by GLI- and GOLD-based criteria. Next, in GLI- and GOLD-based airflow obstruction, modified intention-to-treat analyses evaluated differences in time to death over 4 years, comparing tiotropium vs placebo. Because treatment response may differ by COPD severity, the mortality effect also was evaluated within stratum defined by GLI- and GOLD-based moderate and severe airflow obstruction.
RESULTS


Of 5,898 participants with GOLD-based airflow-obstruction, staged as moderate in 2,739 (46.4%) and severe in 3,156 (53.5%), GLI-based criteria established airflow obstruction in 5,750 (97.5%), staged as moderate in 795 (13.5%) and severe in 4,947 (83.9%). Relative to placebo, tiotropium yielded statistically nonsignificant adjusted hazard ratios (adjHRs) (95% CI) for death of 0.91 (0.80, 1.04) and 0.91 (0.79, 1.03) in GLI- and GOLD-based airflow obstruction, respectively. However, statistically significant effect modification was observed, but only in GLI-based moderate and severe airflow-obstruction, with tiotropium yielding adjHRs for death of 0.53 (0.34, 0.81) and 0.99 (0.86, 1.13), respectively. The P value for interaction was .007.
INTERPRETATION


Mortality reduction by tiotropium was only statistically significant in GLI-based moderate airflow-obstruction, a group that was underrepresented in UPLIFT because of severity misclassification by the original GOLD-based enrollment criteria.",2020,"Relative to placebo, tiotropium yielded statistically non-significant adjusted hazard ratios (adjHRs) (95% confidence interval) for death of 0.91 (0.80, 1.04) and 0.91 (0.79, 1.03) in GLI- and GOLD-based airflow-obstruction, respectively.","['and Methods', 'chronic obstructive pulmonary disease (COPD), i.e. UPLIFT, enrolled adults with a mean age of 65 years and moderate-to-severe airflow-obstruction, based on criteria from the Global Initiative for Chronic Obstructive Lung Disease (GOLD', '5898 participants with GOLD-based']","['placebo, tiotropium', 'tiotropium', 'tiotropium vs. placebo']","['GLI-based moderate and severe airflow-obstruction', 'GLI-based criteria established airflow-obstruction', 'hazard ratios (adjHRs', 'mortality effect', 'Mortality reduction', 'airflow-obstruction']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",5898.0,0.179374,"Relative to placebo, tiotropium yielded statistically non-significant adjusted hazard ratios (adjHRs) (95% confidence interval) for death of 0.91 (0.80, 1.04) and 0.91 (0.79, 1.03) in GLI- and GOLD-based airflow-obstruction, respectively.","[{'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Vaz Fragoso', 'Affiliation': 'Veterans Affairs (VA) Connecticut Healthcare System, West Haven; Yale University School of Medicine, Department of Internal Medicine, New Haven, CT. Electronic address: carlos.fragoso@yale.edu.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Leo-Summers', 'Affiliation': 'Yale University School of Medicine, Department of Internal Medicine, New Haven, CT.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gill', 'Affiliation': 'Yale University School of Medicine, Department of Internal Medicine, New Haven, CT.'}, {'ForeName': 'Gail J', 'Initials': 'GJ', 'LastName': 'McAvay', 'Affiliation': 'Yale University School of Medicine, Department of Internal Medicine, New Haven, CT.'}]",Chest,['10.1016/j.chest.2020.02.070']
453,31426018,Deceptive but not open label placebos attenuate motion-induced nausea.,"OBJECTIVE


Nausea is a common complaint, known to respond to the placebo effect. Existing research has employed deception when administering placebos for nausea, limiting therapeutic translation on ethical grounds. We therefore examined the potential of non-deceptive open-label placebos (OLPs) to reduce nausea.
METHODS


Galvanic Vestibular Stimulation (GVS) and Virtual Reality (VR) were employed to model nausea in healthy volunteers across two experiments. In both experiments nausea was elicited with and without sham treatment (peppermint vapor and brain stimulation, respectively). In Exp. 1, participants (n = 61) were randomized to deceptive placebo, semi-open placebo, fully-open placebo, or control. In Exp. 2, participants (n = 93) were randomized to deceptive placebo, semi-open placebo, or control.
RESULTS


Exp. 1 found limited evidence for a placebo effect (F(1, 56) = 1.15, p = .29, η p 2  =0.02), even following deceptive treatment (F(1, 56) = 1.92, p = .17, η p 2 =0.03). In Exp. 2, deceptive placebo reduced nausea relative to control (F(1, 89) = 6.91, p = .010, η p 2 =0.07) and OLP (F(1, 89) = 5.47, p = .022, η p 2 =0.06). Pooled Bayesian analysis across experiments provided strong evidence that deceptive placebos reduce nausea relative to control (BF 10  = 30.91) and anecdotal evidence for the benefit of deceptive treatment over non-deceptive (BF 10  = 2.46) and no benefit of OLP over control (BF 10  = 0.63).
CONCLUSIONS


No positive evidence for OLP effects in nausea were observed. However, a deceptive effect in VR was observed. These findings raise questions regarding the efficacy of open-label intervention in nausea.",2019,"In Exp. 2, deceptive placebo reduced nausea relative to control (F(1, 89) = 6.91, p = .010, η p 2 =0.07) and OLP (F(1, 89) = 5.47, p = .022, η p 2 =0.06).","['participants (n\u202f=\u202f61', 'participants (n\u202f=\u202f93', 'healthy volunteers across two experiments']","['deceptive placebo, semi-open placebo, or control', 'non-deceptive open-label placebos (OLPs', 'Galvanic Vestibular Stimulation (GVS) and Virtual Reality (VR', 'deceptive placebo, semi-open placebo, fully-open placebo, or control']","['OLP effects in nausea', 'nausea relative', 'nausea', 'OLP']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}]",,0.412805,"In Exp. 2, deceptive placebo reduced nausea relative to control (F(1, 89) = 6.91, p = .010, η p 2 =0.07) and OLP (F(1, 89) = 5.47, p = .022, η p 2 =0.06).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Barnes', 'Affiliation': 'University of Sydney, Australia. Electronic address: kirsten.barnes@sydney.edu.au.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Yu', 'Affiliation': 'University of Sydney, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Josupeit', 'Affiliation': 'Heinrich-Heine University, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Colagiuri', 'Affiliation': 'University of Sydney, Australia.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2019.109808']
454,30718038,Pretreatment Rostral Anterior Cingulate Cortex Connectivity With Salience Network Predicts Depression Recovery: Findings From the EMBARC Randomized Clinical Trial.,"BACKGROUND


Baseline rostral anterior cingulate cortex (rACC) activity is a well-replicated nonspecific predictor of depression improvement. The rACC is a key hub of the default mode network, which prior studies indicate is hyperactive in major depressive disorder. Because default mode network downregulation is reliant on input from the salience network and frontoparietal network, an important question is whether rACC connectivity with these systems contributes to depression improvement.
METHODS


Our study evaluated this hypothesis in outpatients (N = 238; 151 female) enrolled in the Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care (EMBARC) 8-week randomized clinical trial of sertraline versus placebo for major depressive disorder. Depression severity was measured using the Hamilton Rating Scale for Depression, and electroencephalography was recorded at baseline and week 1. Exact low-resolution electromagnetic tomography was used to compute activity from the rACC, and key regions within the default mode network (posterior cingulate cortex), frontoparietal network (left dorsolateral prefrontal cortex), and salience network (right anterior insula [rAI]). Connectivity in the theta band (4.5-7 Hz) and beta band (12.5-21 Hz) was computed using lagged phase synchronization.
RESULTS


Stronger baseline theta-band rACC-rAI (salience network hub) connectivity predicted greater depression improvement across 8 weeks of treatment for both treatment arms (B = -0.57, 95% confidence interval = -1.07, -0.08, p = .03). Early increases in theta-band rACC-rAI connectivity predicted greater likelihood of achieving remission at week 8 (odds ratio = 2.90, p = .03).
CONCLUSIONS


Among patients undergoing treatment, theta-band rACC-rAI connectivity is a prognostic, albeit treatment-nonspecific, indicator of depression improvement, and early connectivity changes may predict clinically meaningful outcomes.",2019,"Connectivity in the theta band (4.5-7 Hz) and beta band (12.5-21 Hz) was computed using lagged phase synchronization.
","['outpatients', 'N\xa0= 238; 151 female) enrolled in the Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care (EMBARC) 8-week randomized clinical trial of']","['sertraline versus placebo', 'rACC-rAI']","['Depression severity', 'Hamilton Rating Scale for Depression, and electroencephalography', 'theta-band rACC-rAI connectivity predicted greater likelihood of achieving remission', 'depression improvement']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.128581,"Connectivity in the theta band (4.5-7 Hz) and beta band (12.5-21 Hz) was computed using lagged phase synchronization.
","[{'ForeName': 'Alexis E', 'Initials': 'AE', 'LastName': 'Whitton', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts; Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, Massachusetts.'}, {'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Webb', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts; Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, Massachusetts.'}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Dillon', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts; Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, Massachusetts.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Kayser', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, New York.'}, {'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'Rutherford', 'Affiliation': 'Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, Massachusetts.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Goer', 'Affiliation': 'Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, Massachusetts.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts; Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'McGrath', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, New York.'}, {'ForeName': 'Myrna', 'Initials': 'M', 'LastName': 'Weissman', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, New York.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Parsey', 'Affiliation': 'Department of Psychiatry, Stony Brook University, Stony Brook, New York.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, New York.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Trombello', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Deldin', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Oquendo', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Melvin G', 'Initials': 'MG', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Carmody', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Bruder', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, New York.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts; Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, Massachusetts. Electronic address: dap@mclean.harvard.edu.'}]",Biological psychiatry,['10.1016/j.biopsych.2018.12.007']
455,32277809,"Clofazimine for treatment of cryptosporidiosis in HIV-infected adults (CRYPTOFAZ): an experimental medicine, randomized, double-blind, placebo-controlled phase 2a trial.","BACKGROUND


We evaluated efficacy, pharmacokinetics (PK), and safety of clofazimine (CFZ) in HIV-infected patients with cryptosporidiosis.
METHODS


We performed a randomized, double-blind, placebo-controlled study. Primary outcomes in Part A were reduction in Cryptosporidium shedding, safety, and PK. Primary analysis was according to protocol (ATP). Part B of the study compared CFZ PK in matched HIV-infected individuals without cryptosporidiosis.
RESULTS


Twenty Part A and 10 Part B participants completed the study ATP. Almost all Part A participants had high viral loads and low CD4 counts, consistent with failure of antiretroviral (ARV) therapy. At study entry, the Part A CFZ group had higher Cryptosporidium shedding, total stool weight, and more diarrheal episodes compared to the placebo group. Over the inpatient period, compared to those who received placebo, the CFZ group Cryptosporidium shedding increased by 2.17 log2Cryptosporidium per gram stool (95% upper confidence limit: 3.82), total stool weight decreased by 45.3 g (p=0.37), and number of diarrheal episodes increased by 2.32 (p=0.87). The most frequent solicited adverse effects were diarrhea, abdominal pain, and malaise. Three CFZ and 1 placebo subjects died during the study. Plasma levels of CFZ in participants with cryptosporidiosis were 2-fold lower than Part B controls.
CONCLUSION


Our findings do not support the efficacy of CFZ for the treatment of cryptosporidiosis in a severely immunocompromised HIV population. However, this trial demonstrates a pathway to assess the therapeutic potential of drugs for cryptosporidiosis treatment. Screening persons with HIV for diarrhea, and especially Cryptosporidium infection, may identify those failing ARV therapy.",2020,"Over the inpatient period, compared to those who received placebo, the CFZ group Cryptosporidium shedding increased by 2.17 log2Cryptosporidium per gram stool (95% upper confidence limit: 3.82), total stool weight decreased by 45.3 g (p=0.37), and number of diarrheal episodes increased by 2.32 (p=0.87).","['HIV-infected patients with cryptosporidiosis', 'participants with cryptosporidiosis', 'Twenty Part A and 10 Part B participants completed the study ATP', 'Screening persons with HIV for diarrhea, and especially Cryptosporidium infection', 'HIV-infected adults (CRYPTOFAZ']","['CFZ PK', 'placebo', 'Clofazimine', 'CFZ', 'clofazimine (CFZ']","['Cryptosporidium shedding, total stool weight, and more diarrheal episodes', 'diarrhea, abdominal pain, and malaise', 'Plasma levels of CFZ', 'total stool weight', 'number of diarrheal episodes', 'Cryptosporidium shedding', 'efficacy, pharmacokinetics (PK', 'failure of antiretroviral (ARV) therapy', 'high viral loads and low CD4 counts', 'Cryptosporidium shedding, safety, and PK']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010418', 'cui_str': 'Cryptosporidiosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0008996', 'cui_str': 'Clofazimine'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1744526', 'cui_str': 'Cryptosporidium'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008996', 'cui_str': 'Clofazimine'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.592087,"Over the inpatient period, compared to those who received placebo, the CFZ group Cryptosporidium shedding increased by 2.17 log2Cryptosporidium per gram stool (95% upper confidence limit: 3.82), total stool weight decreased by 45.3 g (p=0.37), and number of diarrheal episodes increased by 2.32 (p=0.87).","[{'ForeName': 'P Y', 'Initials': 'PY', 'LastName': 'Iroh Tam', 'Affiliation': 'Malawi-Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'S L M', 'Initials': 'SLM', 'LastName': 'Arnold', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'L K', 'Initials': 'LK', 'LastName': 'Barrett', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Chen', 'Affiliation': 'Emmes, Rockville, MD, USA.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Conrad', 'Affiliation': 'Emmes, Rockville, MD, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Douglas', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Gordon', 'Affiliation': 'Malawi-Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hebert', 'Affiliation': 'Emmes, Rockville, MD, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Henrion', 'Affiliation': 'Malawi-Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hermann', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, WA, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hollingsworth', 'Affiliation': 'Emmes, Rockville, MD, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Houpt', 'Affiliation': ''}, {'ForeName': 'K C', 'Initials': 'KC', 'LastName': 'Jere', 'Affiliation': 'Malawi-Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lindblad', 'Affiliation': 'Emmes, Rockville, MD, USA.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Love', 'Affiliation': 'Calibr, La Jolla, CA, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Makhaza', 'Affiliation': 'Malawi-Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'C W', 'Initials': 'CW', 'LastName': 'McNamara', 'Affiliation': 'Calibr, La Jolla, CA, USA.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Nedi', 'Affiliation': 'Malawi-Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nyirenda', 'Affiliation': 'Malawi-Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Operario', 'Affiliation': 'University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Phulusa', 'Affiliation': 'Malawi-Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Quinnan', 'Affiliation': 'Emmes, Rockville, MD, USA.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Sawyer', 'Affiliation': 'Emmes, Rockville, MD, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Thole', 'Affiliation': 'Malawi-Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Toto', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Winter', 'Affiliation': 'Emmes, Rockville, MD, USA.'}, {'ForeName': 'W C', 'Initials': 'WC', 'LastName': 'Van Voorhis', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa421']
456,32277977,The influence of prolonged strength training upon muscle and fat in healthy and chronically diseased older adults.,"BACKGROUND


Physical muscle function and brain hippocampus size declines with age, accelerating after the age of 60. Strength training over a few months improves physical function, but less is known about how long-term strength training affects physical function and hippocampus volume. Therefore, we aimed to investigate the effect of 1-year strength training of two different intensities upon muscle mass, function, and hippocampus volume in retirement-age individuals.
METHODS


In this multidisciplinary randomized controlled trial (clinicaltrials.gov: NCT02123641), participants were allocated to either a) supervised, heavy resistance training (HRT, n = 149, 3/wk), b) moderate intensity resistance training (MIT, n = 154, 3/wk) or c) non-exercise activities (CON, n = 148). 451 participants were randomized (62-70 yrs., women 61%, ≈80% with a chronic medical disease) and 419 were included in the intention-to-treat analysis (n = 143, 144 and 132; HRT, MIT and CON). Changes in muscle power (primary outcome), strength and size, physical function, body composition, hippocampus volume and physical/mental well-being were analyzed.
FINDINGS


Of the participants (HRT + MIT), 83% completed training at least 2/week. Leg extensor power was unchanged in all groups, but strength training had a positive effect on isometric knee extensor strength in both groups, whereas an increased muscle mass, cross-sectional area of vastus lateralis muscle, a decreased whole-body fat percentage, visceral fat content and an improved mental health (SF-36) occurred in HRT only. Further, chair-stand performance improved in all groups, whereas hippocampus volume decreased in all groups over time with no influence of strength training.
INTERPRETATION


Together, the results indicate that leg extensor power did not respond to long-term supervised strength training, but this type of training in a mixed group of healthy and chronically diseased elderly individuals can be implemented with good compliance and induces consistent changes in physiological parameters of muscle strength, muscle mass and abdominal fat.",2020,"Leg extensor power was unchanged in all groups, but strength training had a positive effect on isometric knee extensor strength in both groups, whereas an increased muscle mass, cross-sectional area of vastus lateralis muscle, a decreased whole-body fat percentage, visceral fat content and an improved mental health (SF-36) occurred in HRT only.","['retirement-age individuals', ' women 61%, ≈80% with a chronic medical disease) and 419 were included in the intention-to-treat analysis (n\u202f=\u202f143, 144 and 132; HRT, MIT and CON', '451 participants were randomized (62-70\u202fyrs', 'healthy and chronically diseased older adults']","['heavy resistance training (HRT, n\u202f=\u202f149, 3/wk), b) moderate intensity resistance training (MIT, n\u202f=\u202f154, 3/wk) or c) non-exercise activities (CON, n\u202f=\u202f148', 'prolonged strength training', 'Strength training']","['Changes in muscle power (primary outcome), strength and size, physical function, body composition, hippocampus volume and physical/mental well-being were analyzed', 'hippocampus volume', 'increased muscle mass, cross-sectional area of vastus lateralis muscle, a decreased whole-body fat percentage, visceral fat content and an improved mental health (SF-36', 'Leg extensor power', 'physical function', 'chair-stand performance', 'isometric knee extensor strength']","[{'cui': 'C0035345', 'cui_str': 'Retired'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]",451.0,0.032446,"Leg extensor power was unchanged in all groups, but strength training had a positive effect on isometric knee extensor strength in both groups, whereas an increased muscle mass, cross-sectional area of vastus lateralis muscle, a decreased whole-body fat percentage, visceral fat content and an improved mental health (SF-36) occurred in HRT only.","[{'ForeName': 'Anne Theil', 'Initials': 'AT', 'LastName': 'Gylling', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark. Electronic address: anne.theil.gylling@regionh.dk.'}, {'ForeName': 'Christian Skou', 'Initials': 'CS', 'LastName': 'Eriksen', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Garde', 'Affiliation': 'Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark; Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark; Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Øster Farimagsgade 5A, 1353 Copenhagen K, Denmark.'}, {'ForeName': 'Cathrine Lawaetz', 'Initials': 'CL', 'LastName': 'Wimmelmann', 'Affiliation': 'Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark; Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Øster Farimagsgade 5A, 1353 Copenhagen K, Denmark.'}, {'ForeName': 'Nina Linde', 'Initials': 'NL', 'LastName': 'Reislev', 'Affiliation': 'Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark; Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Bieler', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark; Department of Physical and Occupational Therapy, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark.'}, {'ForeName': 'Andreas Kraag', 'Initials': 'AK', 'LastName': 'Ziegler', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Kasper Winther', 'Initials': 'KW', 'LastName': 'Andersen', 'Affiliation': 'Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bauer', 'Affiliation': 'Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark; Department of Technology, University College Copenhagen, Sigurdsgade 26, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Dideriksen', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Baekgaard', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Kenneth Hudlebusch', 'Initials': 'KH', 'LastName': 'Mertz', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Monika Lucia', 'Initials': 'ML', 'LastName': 'Bayer', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Bloch-Ibenfeldt', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Carl-Johan', 'Initials': 'CJ', 'LastName': 'Boraxbekk', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark; Department of Radiation Sciences, Umeå University, S-901 87 Umeå, Sweden.'}, {'ForeName': 'Hartwig Roman', 'Initials': 'HR', 'LastName': 'Siebner', 'Affiliation': 'Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark; Department of Neurology, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark.'}, {'ForeName': 'Erik Lykke', 'Initials': 'EL', 'LastName': 'Mortensen', 'Affiliation': 'Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark; Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Øster Farimagsgade 5A, 1353 Copenhagen K, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kjaer', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}]",Experimental gerontology,['10.1016/j.exger.2020.110939']
457,32270133,"""When I Eat Well, I Will Be Healthy, and the Child Will Also Be Healthy"": Maternal Nutrition among HIV-Infected Women Enrolled in a Livelihood Intervention in Western Kenya.","Background


Food insecurity remains a major obstacle to achieving health and well-being for individuals living with HIV in western Kenya. Studies have shown that pregnant women are vulnerable to experiencing food insecurity worldwide, with significant consequences for both maternal and child health. The  Shamba Maisha  cluster randomized controlled trial in western Kenya (which means ""farming for life"" in Swahili) tested the effects of a multisectoral livelihood intervention consisting of agricultural and finance trainings, farm inputs, and a loan on health and food security among 746 farmers living with HIV in Kisumu, Homa Bay, and Migori Counties.
Objectives


We conducted a qualitative substudy within the  Shamba Maisha  trial to understand the experiences and perspectives of pregnant women living with HIV enrolled in the trial.
Methods


Thirty women who had experienced a pregnancy during the  Shamba Maisha  study period, comprising 20 women in the intervention arm and 10 women in the control arm, completed in-depth interviews using a semistructured interview guide.
Results


Intervention participants interviewed noted improvements in maternal nutrition compared with previous pregnancies, which they attributed to the livelihood intervention. Key identified pathways to improved nutrition included improved access to vegetables, increased variety of diet through vegetable sales, and improved nutritional awareness. Women in the intervention arm also perceived increased weight gain compared with prior pregnancies and increased strength and energy throughout pregnancy.
Conclusions


Livelihood interventions represent a promising solution to alleviate food insecurity for pregnant women in order to improve maternal and child health outcomes.This trial was registered at clinicaltrials.gov as NCT02815579.",2020,"Conclusions


Livelihood interventions represent a promising solution to alleviate food insecurity for pregnant women in order to improve maternal and child health outcomes.","['pregnant women living with HIV enrolled in the trial', 'Thirty women who had experienced a pregnancy during the  Shamba Maisha  study period, comprising 20 women in the intervention arm and 10 women in the control arm, completed in-depth interviews using a semistructured interview guide', 'pregnant women', 'western Kenya (which means ""farming for life"" in Swahili', 'HIV-Infected Women Enrolled in a Livelihood Intervention in Western Kenya', 'individuals living with HIV in western Kenya', '746 farmers living with HIV in Kisumu, Homa Bay, and Migori Counties']",['multisectoral livelihood intervention'],"['nutritional awareness', 'strength and energy throughout pregnancy', 'maternal nutrition', 'weight gain']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0557759', 'cui_str': 'Farming environment'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0038977', 'cui_str': 'Swahili language'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0221460', 'cui_str': 'Farmer'}, {'cui': 'C3203003', 'cui_str': 'Bays'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1720845', 'cui_str': 'Maternal Nutritional Physiological Phenomenon'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",20.0,0.0842693,"Conclusions


Livelihood interventions represent a promising solution to alleviate food insecurity for pregnant women in order to improve maternal and child health outcomes.","[{'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'McDonough', 'Affiliation': 'San Francisco School of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sheri D', 'Initials': 'SD', 'LastName': 'Weiser', 'Affiliation': 'Division of HIV, Infectious Diseases, and Global Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Afkera', 'Initials': 'A', 'LastName': 'Daniel', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Elly', 'Initials': 'E', 'LastName': 'Weke', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Wekesa', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Burger', 'Affiliation': 'Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Lila', 'Initials': 'L', 'LastName': 'Sheira', 'Affiliation': 'Division of HIV, Infectious Diseases, and Global Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Cohen', 'Affiliation': 'Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco, San Francisco, CA, USA.'}]",Current developments in nutrition,['10.1093/cdn/nzaa032']
458,31253407,Randomized Controlled Trial of Iron-Fortified versus Low-Iron Infant Formula: Developmental Outcomes at 16 Years.,"OBJECTIVES


To test differences in cognitive outcomes among adolescents randomly assigned previously as infants to iron-fortified formula or low-iron formula as part of an iron deficiency anemia prevention trial.
STUDY DESIGN


Infants were recruited from community clinics in low- to middle-income neighborhoods in Santiago, Chile. Entrance criteria included term, singleton infants; birth weight of ≥3.0 kg; and no major congenital anomalies, perinatal complications, phototherapy, hospitalization >5 days, chronic illness, or iron deficiency anemia at 6 months. Six-month-old infants were randomized to iron-fortified (12 mg/L) or low-iron (2.3 mg/L) formula for 6 months. At 16 years of age, cognitive ability, visual perceptual ability, visual memory, and achievement in math, vocabulary, and comprehension were assessed, using standardized measures. We compared differences in developmental test scores according to randomization group.
RESULTS


At the follow-up assessment, the 405 participants averaged 16.2 years of age and 46% were male. Those randomized to iron-fortified formula had lower scores than those randomized to low-iron formula for visual memory, arithmetic achievement, and reading comprehension achievement. For visual motor integration, there was an interaction with baseline infancy hemoglobin, such that the iron-fortified group outperformed the low-iron group when 6-month hemoglobin was low and underperformed when 6-month hemoglobin was high.
CONCLUSIONS


Adolescents who received iron-fortified formula as infants from 6 to 12 months of age at levels recommended in the US had poorer cognitive outcomes compared with those who received a low-iron formula. The prevention of iron deficiency anemia in infancy is important for brain development. However, the optimal level of iron supplementation in infancy is unclear.
TRIAL REGISTRATION


Clinicaltrials.gov: NCT01166451.",2019,"Those randomized to iron-fortified formula had lower scores than those randomized to low-iron formula for visual memory, arithmetic achievement, and reading comprehension achievement.","['adolescents randomly assigned previously as infants to', 'Infants were recruited from community clinics in low- to middle-income neighborhoods in Santiago, Chile', 'Entrance criteria included term, singleton infants; birth weight of ≥3.0\xa0kg; and no major congenital anomalies, perinatal complications, phototherapy, hospitalization >5\xa0days, chronic illness, or iron deficiency anemia at 6\xa0months', 'Six-month-old infants', '405 participants averaged 16.2\xa0years of age and 46% were male']","['Iron-Fortified versus Low-Iron Infant Formula', 'iron-fortified (12\xa0mg/L) or low-iron', 'iron-fortified formula or low-iron formula', 'iron-fortified formula']","['cognitive outcomes', 'cognitive ability, visual perceptual ability, visual memory, and achievement in math, vocabulary, and comprehension', 'visual memory, arithmetic achievement, and reading comprehension achievement']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0587907', 'cui_str': 'Community clinic (environment)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0008107', 'cui_str': 'Chile'}, {'cui': 'C0337095', 'cui_str': 'Entrance (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4517768', 'cui_str': 'Four hundred and five'}, {'cui': 'C4319690', 'cui_str': '16.2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0150589', 'cui_str': 'Baby Formula'}, {'cui': 'C0439268', 'cui_str': 'microgram/mL'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0542316', 'cui_str': 'Visual memory (observable entity)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]",405.0,0.226213,"Those randomized to iron-fortified formula had lower scores than those randomized to low-iron formula for visual memory, arithmetic achievement, and reading comprehension achievement.","[{'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Gahagan', 'Affiliation': 'Department of Pediatrics, Division of Child Development and Community Health, University of California, San Diego, La Jolla, CA; Center for Human Growth and Development and Department of Pediatrics and Communicable Diseases, University of Michigan, Ann Arbor, MI. Electronic address: sgahagan@ucsd.edu.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Delker', 'Affiliation': 'Department of Pediatrics, Division of Child Development and Community Health, University of California, San Diego, La Jolla, CA; Department of Epidemiology, San Diego State University/University of California at San Diego Joint Doctoral Program, San Diego, CA.'}, {'ForeName': 'Estela', 'Initials': 'E', 'LastName': 'Blanco', 'Affiliation': 'Department of Pediatrics, Division of Child Development and Community Health, University of California, San Diego, La Jolla, CA; Department of Public Health, University of Chile, Doctoral Program, Santiago, Chile.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Burrows', 'Affiliation': 'Institute of Nutrition and Food Technology, University of Chile, Santiago, Chile.'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Lozoff', 'Affiliation': 'Center for Human Growth and Development and Department of Pediatrics and Communicable Diseases, University of Michigan, Ann Arbor, MI.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.05.030']
459,32279227,Efficacy of Postbiotics in a PRP-Like Cosmetic Product for the Treatment of Alopecia Area Celsi: A Randomized Double-Blinded Parallel-Group Study.,"INTRODUCTION


Alopecia areata (AA), also known as 'area Celsi', is the second most common form of hair loss affecting the scalp. Newly proposed treatments for AA include low-level light therapy, biologics such as Janus kinase inhibitors and autologous platelet-rich plasma (PRP), which is a well-known ""elixir"" for hair growth. Bioactive peptides developed through biotechnological applications have been used to overcome the limitations of PRP. More recently, the involvement of microbiota in hair growth disorders, in AA in particular, has been reported, and the usefulness of microbial metabolites, i.e. postbiotics, has been suggested.
METHODS


This study was a randomized double-blinded parallel-group study in which 160 persons of both sexes affected by AA and aged between 18 and 60 years were enrolled. The subjects were randomly assigned to a treatment group (group 1), receiving the TR-PRP plus-Celsi cosmetic product, and a placebo group (group 2). The SALT (Severity of Alopecia Tool) score was determined in both groups at baseline and after 2 and 3 months of treatment, and the results compared between groups.
RESULTS


The subjects in group 1 showed a significant change from baseline in SALT score at 2 months of treatment (61.04% ± 3.45%; p < 0.0001), with a further improvement at the end of treatment (3 months) (69.56% ± 4.32%; p < 0.0001). No significant changes from baseline were reported for the subjects in group 2 (T1: 26.45% ± 3.64%; T3: 27.63% ± 7.61%).
CONCLUSIONS


The results of this study provide further proof of the efficacy of bioactive peptides that mimick the growth factors present in PRP in subjects affected by AA. They also add to our knowledge of the link between microbiota and hair growth disorders, emphasizing the importance of studies on the microbial community and microbial metabolites as a novel therapeutic approach.",2020,"No significant changes from baseline were reported for the subjects in group 2 (T1: 26.45% ± 3.64%; T3: 27.63% ± 7.61%).
","['Alopecia Area Celsi', '160 persons of both sexes affected by AA and aged between 18 and 60\xa0years were enrolled']","['Postbiotics', 'PRP-Like Cosmetic Product', 'TR-PRP plus-Celsi cosmetic product, and a placebo']","['SALT (Severity of Alopecia Tool) score', 'SALT score']","[{'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.108524,"No significant changes from baseline were reported for the subjects in group 2 (T1: 26.45% ± 3.64%; T3: 27.63% ± 7.61%).
","[{'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Rinaldi', 'Affiliation': 'Human Advanced Microbiome Project (HMAP), Giuliani SpA, Milan, Italy. fabio.rinaldi@studiorinaldi.com.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Trink', 'Affiliation': 'Human Advanced Microbiome Project (HMAP), Giuliani SpA, Milan, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pinto', 'Affiliation': 'Human Advanced Microbiome Project (HMAP), Giuliani SpA, Milan, Italy.'}]",Dermatology and therapy,['10.1007/s13555-020-00369-9']
460,32275191,IL (Interleukin)-1 Receptor Antagonist Increases Ang (Angiotensin [1-7]) and Decreases Blood Pressure in Obese Individuals.,"IL (Interleukin)-1 antagonism decreases blood pressure in obese individuals. The underlying mechanisms are unknown. Based on experimental data, we hypothesized an effect of IL-1 antagonism via modulation of the renin-angiotensin-aldosterone system. In this explorative study, we examined shorter- (2 days) and longer-term effects (4 weeks) of IL-1 antagonism (anakinra/Kineret) on renin-angiotensin system peptide profiles and on hemodynamic parameters assessed by noninvasive measurement in obese (body mass index ≥30 kg/m 2 ) individuals from 2 interventional trials (a prospective interventional trial [n=73] and a placebo controlled-double blinded interventional trial [n=67]). A total of 140 patients were included. Systolic blood pressure decreased after short-term (absolute difference -5.2 mm Hg [95% CI, -8.5 to -1.8];  P =0.0006) and after longer-term treatment with anakinra (absolute difference -3.9 mm Hg [95% CI, -7.59 to -0.21];  P =0.04), with no change in blood pressure in the placebo group. Upon IL-1 antagonism, equilibrium levels of Ang II (angiotensin II), Ang I, aldosterone, and renin remained unchanged. In contrast, Ang (1-7) peptide levels increased after 4 weeks (between-group difference 16.35 pmol/L [95% CI, 1.22-30.17],  P =0.03), as well as the Ang (1-7)/Ang II ratio (between-group difference 0.42 [95% CI, 0.17-0.67],  P =0.02) in comparison to placebo. Consistently, the stroke systemic vascular resistance index significantly decreased in the anakinra group (between-group difference of -62.65 dyn/sec per cm -5  per m 2  [95% CI, -116.94 to -18.36],  P =0.008, consistent with a 25% decrease). IL-1 antagonism increased the vasodilatory Ang (1-7) peptide after 4 weeks of treatment in obese individuals, paralleled by a decrease in peripheral vascular resistance. These findings point to an IL-1 mediated blood pressure-lowering mechanism via modulation of Ang (1-7). Registration- URL: https://www.clinicaltrials.gov. Unique identifiers: NCT02227420 and NCT02672592.",2020,"IL-1 antagonism increased the vasodilatory Ang (1-7) peptide after 4 weeks of treatment in obese individuals, paralleled by a decrease in peripheral vascular resistance.","['A total of 140 patients were included', 'obese individuals', 'Obese Individuals', 'obese (body mass index ≥30 kg/m 2 ) individuals from 2 interventional trials (a prospective interventional trial [n=73] and a']","['IL (Interleukin)-1 Receptor Antagonist', 'IL (Interleukin)-1 antagonism', 'placebo', 'IL-1 antagonism (anakinra/Kineret']","['stroke systemic vascular resistance index', 'blood pressure', 'peripheral vascular resistance', 'Systolic blood pressure', 'Blood Pressure', 'IL-1 antagonism', 'IL-1 antagonism, equilibrium levels of Ang II (angiotensin II), Ang I, aldosterone, and renin', 'peptide levels']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}]","[{'cui': 'C0063710', 'cui_str': 'Interleukin 1 Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C1170364', 'cui_str': 'Kineret'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0456260', 'cui_str': 'Systemic vascular resistance index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0051844', 'cui_str': 'Angiogenin'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}]",140.0,0.698881,"IL-1 antagonism increased the vasodilatory Ang (1-7) peptide after 4 weeks of treatment in obese individuals, paralleled by a decrease in peripheral vascular resistance.","[{'ForeName': 'Sandrine Andrea', 'Initials': 'SA', 'LastName': 'Urwyler', 'Affiliation': 'From the Department of Endocrinology, Diabetology and Metabolism (S.A.U., F.E., M.Y.D., M.C.-C.), University Hospital Basel, Switzerland.'}, {'ForeName': 'Fahim', 'Initials': 'F', 'LastName': 'Ebrahimi', 'Affiliation': 'From the Department of Endocrinology, Diabetology and Metabolism (S.A.U., F.E., M.Y.D., M.C.-C.), University Hospital Basel, Switzerland.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Burkard', 'Affiliation': 'Department of Clinical Research (S.A.U., F.E., T.B., P.S., B.M., M.Y.D., M.C.-C.), University Hospital Basel, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Schuetz', 'Affiliation': 'Department of Clinical Research (S.A.U., F.E., T.B., P.S., B.M., M.Y.D., M.C.-C.), University Hospital Basel, Switzerland.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Poglitsch', 'Affiliation': 'Attoquant Diagnostics GmbH, Campus-Vienna-Biocenter, Vienna, Austria (M.P.).'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Mueller', 'Affiliation': 'Department of Clinical Research (S.A.U., F.E., T.B., P.S., B.M., M.Y.D., M.C.-C.), University Hospital Basel, Switzerland.'}, {'ForeName': 'Marc Y', 'Initials': 'MY', 'LastName': 'Donath', 'Affiliation': 'From the Department of Endocrinology, Diabetology and Metabolism (S.A.U., F.E., M.Y.D., M.C.-C.), University Hospital Basel, Switzerland.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Christ-Crain', 'Affiliation': 'From the Department of Endocrinology, Diabetology and Metabolism (S.A.U., F.E., M.Y.D., M.C.-C.), University Hospital Basel, Switzerland.'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.119.13982']
461,30583852,Neural Indicators of Anhedonia: Predictors and Mechanisms of Treatment Change in a Randomized Clinical Trial in Early Childhood Depression.,"BACKGROUND


Early childhood depression is associated with anhedonia and reduced event-related potential (ERP) responses to rewarding or pleasant stimuli. Whether these neural measures are indicators of target engagement or treatment outcome is not yet known.
METHODS


We measured ERP responses to win and loss feedback in a guessing task and to pleasant versus neutral pictures in young (4.0-6.9 years of age) depressed children before and after randomization to either 18 weeks of Parent-Child Interaction Therapy-Emotion Development (PCIT-ED) treatment or waitlist (WL) control condition.
RESULTS


Analyses included reward positivity (RewP) data from 118 children randomized to PCIT-ED treatment (n = 60) or WL control condition (n = 58) at baseline and late positive potential (LPP) data from 99 children (44 PCIT-ED treatment vs. 55 WL control condition) at baseline. Children in the PCIT-ED group showed a greater reduction in anhedonia (F 1,103  = 10.32, p = .002, partial η 2  = .09). RewP reward responses increased more (F 1,87  = 5.45, p = .02, partial η 2  = .06) for PCIT-ED and a greater change in RewP was associated with a greater reduction in major depressive disorder symptoms (r = -.24, p = .05). Baseline RewP did not predict treatment change. LPPs to positive pictures did not change across treatment, but greater baseline LPPs to positive pictures predicted a higher likelihood of remission from major depressive disorder in the PCIT-ED group (B = 0.14; SE = 0.07; odds ratio = 1.15; p = .03).
CONCLUSIONS


The ERP reward response improved in young children with depression during a treatment designed to enhance emotion development, providing evidence of target engagement of the neural systems associated with reward. Further, greater baseline LPP responses to positive pictures were associated with a greater reduction in depression, suggesting that this ERP measure can predict which children are most likely to respond to treatment.",2019,"RewP reward responses increased more (F 1,87  = 5.45, p = .02, partial η 2  = .06) for PCIT-ED and a greater change in RewP was associated with a greater reduction in major depressive disorder symptoms (r = -.24, p = .05).","['Early Childhood Depression', 'in young (4.0-6.9 years of age) depressed children before and after randomization to either 18 weeks of']","['Parent-Child Interaction Therapy-Emotion Development (PCIT-ED) treatment or waitlist (WL) control condition', 'guessing task and to pleasant versus neutral pictures']","['RewP reward responses', 'ERP responses', 'major depressive disorder symptoms', 'anhedonia', 'ERP reward response']","[{'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0337380', 'cui_str': 'Endoscopic retrograde pancreatography (procedure)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}]",118.0,0.226379,"RewP reward responses increased more (F 1,87  = 5.45, p = .02, partial η 2  = .06) for PCIT-ED and a greater change in RewP was associated with a greater reduction in major depressive disorder symptoms (r = -.24, p = .05).","[{'ForeName': 'Deanna M', 'Initials': 'DM', 'LastName': 'Barch', 'Affiliation': 'Department of Psychological & Brain Sciences, Washington University in St. Louis, St. Louis, Missouri; Department of Psychiatry, Washington University in St. Louis, St. Louis, Missouri; Department of Radiology, Washington University in St. Louis, St. Louis, Missouri. Electronic address: dbarch@wustl.edu.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Whalen', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Gilbert', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Kelly', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Kappenman', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, California.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Hajcak', 'Affiliation': 'Department of Biomedical Science and Psychology, Florida State University, Tallahassee, Florida.'}, {'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Luby', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, Missouri.'}]",Biological psychiatry,['10.1016/j.biopsych.2018.11.021']
462,30088663,Clinical Pharmacology of the Reversible and Potent P2Y 12  Receptor Antagonist ACT-246475 After Single Subcutaneous Administration in Healthy Male Subjects.,"ACT-246475 is a selective and reversible P2Y 12  receptor antagonist inducing inhibition of platelet aggregation (IPA). A randomized, double-blind, placebo-controlled, parallel-design study was performed to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of escalating single subcutaneous doses of ACT-246475 (1, 2, 4, 8, 16, or 32 mg) in healthy male subjects (N = 8 per dose, 3:1 active:placebo ratio). Pharmacodynamic effects were assessed based on maximum platelet aggregation and P2Y 12  reaction units using light transmission aggregometry and VerifyNow ®  assays, respectively. ACT-246475 was safe and well tolerated up to 32 mg based on adverse event data and absence of clinically relevant changes in hematology, biochemistry, vital signs, and electrocardiogram variables. Median time to reach maximum plasma concentration was 0.5-0.75 hours, and geometric mean terminal half-life ranged from 1.3 to 9.2 hours across the tested dose range. Exposure to ACT-246475 was dose proportional across all dose groups. The maximal %IPA was reached within 30 minutes after subcutaneous administration of ACT-246475. A dose-dependent duration and extent of effect were observed based on area under the effect curve and maximum effect data. Similar results were observed for maximum platelet aggregation and P2Y 12  reaction units. The %IPA was ≥85% at doses ≥2 mg. This level of %IPA was extended to at least 12 hours in the 32-mg dose group. The safety and pharmacokinetic/pharmacokinetic profile with quick onset and adequate duration of IPA support further investigation in patients with coronary artery disease.",2019,"ACT-246475 was safe and well tolerated up to 32 mg based on adverse event data and absence of clinically relevant changes in hematology, biochemistry, vital signs, and electrocardiogram variables.","['Healthy Male Subjects', 'patients with coronary artery disease', 'healthy male subjects (N\xa0=\xa08 per dose, 3:1 active:placebo ratio']","['placebo', 'ACT-246475']","['safe and well tolerated', 'Pharmacodynamic effects', 'maximum platelet aggregation', 'safety, tolerability, pharmacokinetics, and pharmacodynamics', 'hematology, biochemistry, vital signs, and electrocardiogram variables', 'Median time to reach maximum plasma concentration', 'maximal %IPA']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4079264', 'cui_str': 'ACT-246475'}]","[{'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0677599', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0518766'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0614109', 'cui_str': 'I(S)pA(S)'}]",,0.15362,"ACT-246475 was safe and well tolerated up to 32 mg based on adverse event data and absence of clinically relevant changes in hematology, biochemistry, vital signs, and electrocardiogram variables.","[{'ForeName': 'Pierre-Eric', 'Initials': 'PE', 'LastName': 'Juif', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Margaux', 'Initials': 'M', 'LastName': 'Boehler', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dobrow', 'Affiliation': 'Biotrial Inc, Newark, NJ, USA.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Ufer', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}]",Journal of clinical pharmacology,['10.1002/jcph.1296']
463,30850461,A Randomized Trial to Train Vulnerable Primary Care Patients to Use a Patient Portal.,"BACKGROUND


Patient portals are becoming ubiquitous. Previous research has documented substantial barriers, especially among vulnerable patient subgroups such as those with lower socioeconomic status or limited health literacy (LHL). We tested the effectiveness of delivering online, video-based portal training to patients in a safety net setting.
METHODS


We created an online video curriculum about accessing the San Francisco Health Network portal, and then randomized 93 English-speaking patients with 1+ chronic diseases to receive 1) an in-person tutorial with a research assistant, or 2) a link to view the videos on their own. We also examined a third, nonrandomized usual care comparison group. The primary outcome was portal log-in (yes/no) 3 to 6 months post-training, assessed via the electronic health record. Secondary outcomes were self-reported attitudes and skills collected via baseline and follow-up surveys.
RESULTS


Mean age was 54 years, 51% had LHL, 60% were nonwhite, 52% were female, 45% reported fair/poor health, and 76% reported daily Internet use. At followup, 21% logged into the portal, with no differences by arm ( P  = .41), but this was higher than the overall clinic rate of 9% ( P  < .01) during the same time period. We found significant prepost improvements in self-rated portal skills ( P  = .03) and eHealth literacy ( P  < .01). Those with LHL were less likely to log in post-training ( P  < .01).
CONCLUSIONS


Both modalities of online training were comparable, and neither mode enabled a majority of vulnerable patients to use portals, especially those with LHL. This suggests that portal training will need to be more intensive or portals need improved usability to meaningfully increase use among diverse patients.",2019,We found significant prepost improvements in self-rated portal skills ( P  = .03) and eHealth literacy ( P  < .01).,"['Mean age was 54 years, 51% had LHL, 60% were nonwhite, 52% were female, 45% reported fair/poor health, and 76% reported daily Internet use', '93 English-speaking patients with 1+ chronic diseases to receive 1) an in-person tutorial with a research assistant, or 2', 'Train Vulnerable Primary Care Patients to Use a Patient Portal']","['online training', 'delivering online, video-based portal training']","['eHealth literacy', 'overall clinic rate', 'portal log-in (yes/no) 3 to 6 months post-training, assessed via the electronic health record', 'self-rated portal skills', 'self-reported attitudes and skills collected via baseline and follow-up surveys']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C2911689', 'cui_str': 'Fair'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0035168'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4277550', 'cui_str': 'Patient Internet Portals'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",93.0,0.0789835,We found significant prepost improvements in self-rated portal skills ( P  = .03) and eHealth literacy ( P  < .01).,"[{'ForeName': 'Courtney R', 'Initials': 'CR', 'LastName': 'Lyles', 'Affiliation': 'From the Center for Vulnerable Populations (CRL, LT, US, MH, NR, DS), Division of General Internal Medicine (CRL, LT, US, MH, NR, DS), UCSF Division of Hospital Medicine (SS), Zuckerberg San Francisco General Hospital Library (SK), University of California-San Francisco, San Francisco, CA; Jonathan and Karin Fielding School of Public Health, University of California-Los Angeles, Los Angeles (LT); Office of Health Informatics, San Francisco Health Network, San Francisco (SS). courtney.lyles@ucsf.edu.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Tieu', 'Affiliation': 'From the Center for Vulnerable Populations (CRL, LT, US, MH, NR, DS), Division of General Internal Medicine (CRL, LT, US, MH, NR, DS), UCSF Division of Hospital Medicine (SS), Zuckerberg San Francisco General Hospital Library (SK), University of California-San Francisco, San Francisco, CA; Jonathan and Karin Fielding School of Public Health, University of California-Los Angeles, Los Angeles (LT); Office of Health Informatics, San Francisco Health Network, San Francisco (SS).'}, {'ForeName': 'Urmimala', 'Initials': 'U', 'LastName': 'Sarkar', 'Affiliation': 'From the Center for Vulnerable Populations (CRL, LT, US, MH, NR, DS), Division of General Internal Medicine (CRL, LT, US, MH, NR, DS), UCSF Division of Hospital Medicine (SS), Zuckerberg San Francisco General Hospital Library (SK), University of California-San Francisco, San Francisco, CA; Jonathan and Karin Fielding School of Public Health, University of California-Los Angeles, Los Angeles (LT); Office of Health Informatics, San Francisco Health Network, San Francisco (SS).'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Kiyoi', 'Affiliation': 'From the Center for Vulnerable Populations (CRL, LT, US, MH, NR, DS), Division of General Internal Medicine (CRL, LT, US, MH, NR, DS), UCSF Division of Hospital Medicine (SS), Zuckerberg San Francisco General Hospital Library (SK), University of California-San Francisco, San Francisco, CA; Jonathan and Karin Fielding School of Public Health, University of California-Los Angeles, Los Angeles (LT); Office of Health Informatics, San Francisco Health Network, San Francisco (SS).'}, {'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Sadasivaiah', 'Affiliation': 'From the Center for Vulnerable Populations (CRL, LT, US, MH, NR, DS), Division of General Internal Medicine (CRL, LT, US, MH, NR, DS), UCSF Division of Hospital Medicine (SS), Zuckerberg San Francisco General Hospital Library (SK), University of California-San Francisco, San Francisco, CA; Jonathan and Karin Fielding School of Public Health, University of California-Los Angeles, Los Angeles (LT); Office of Health Informatics, San Francisco Health Network, San Francisco (SS).'}, {'ForeName': 'Mekhala', 'Initials': 'M', 'LastName': 'Hoskote', 'Affiliation': 'From the Center for Vulnerable Populations (CRL, LT, US, MH, NR, DS), Division of General Internal Medicine (CRL, LT, US, MH, NR, DS), UCSF Division of Hospital Medicine (SS), Zuckerberg San Francisco General Hospital Library (SK), University of California-San Francisco, San Francisco, CA; Jonathan and Karin Fielding School of Public Health, University of California-Los Angeles, Los Angeles (LT); Office of Health Informatics, San Francisco Health Network, San Francisco (SS).'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Ratanawongsa', 'Affiliation': 'From the Center for Vulnerable Populations (CRL, LT, US, MH, NR, DS), Division of General Internal Medicine (CRL, LT, US, MH, NR, DS), UCSF Division of Hospital Medicine (SS), Zuckerberg San Francisco General Hospital Library (SK), University of California-San Francisco, San Francisco, CA; Jonathan and Karin Fielding School of Public Health, University of California-Los Angeles, Los Angeles (LT); Office of Health Informatics, San Francisco Health Network, San Francisco (SS).'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Schillinger', 'Affiliation': 'From the Center for Vulnerable Populations (CRL, LT, US, MH, NR, DS), Division of General Internal Medicine (CRL, LT, US, MH, NR, DS), UCSF Division of Hospital Medicine (SS), Zuckerberg San Francisco General Hospital Library (SK), University of California-San Francisco, San Francisco, CA; Jonathan and Karin Fielding School of Public Health, University of California-Los Angeles, Los Angeles (LT); Office of Health Informatics, San Francisco Health Network, San Francisco (SS).'}]",Journal of the American Board of Family Medicine : JABFM,['10.3122/jabfm.2019.02.180263']
464,32277344,Comparable Effect of Two-Step Versus Extended Infusions on the Pharmacokinetics of Imipenem in Patients with Sepsis and Septic Shock.,"INTRODUCTION


The present study aimed to compare the pharmacokinetic/pharmacodynamic (PK/PD) parameters of imipenem administered by two-step (50% delivered in a 30-min bolus, 50% for the following 90 min) or extended (administered continuously for 2 h) infusion.
METHODS


Patients with sepsis and septic shock were prospectively enrolled and randomized into four groups. Subjects in the two-step or extended groups were given two doses of imipenem (0.5 g q6h and 1.0 g q8h). The plasma imipenem concentrations were measured at given time points after the fifth dose. The PK/PD target was defined as the achievement of a fractional time above the minimal inhibitory concentration (MIC) of > 40%.
RESULTS


Thirty-five patients were eventually enrolled. No significant difference was observed in the percentage of patients achieving 40% T > MIC between the different infusion modes with the same dosage, although the two-step groups exhibited a significantly shorter T max  compared with the extended groups (0.5 g q6h: 1.5 ± 0.8 vs. 2.0 ± 0.0 h; 1.0 g q8h: 1.0 ± 0.6 vs. 2.0 ± 0.0 h; both, p < 0.05). All four groups achieved 40% T > MIC when MIC was 0.5-4.0 μg/ml, but only regimens with a higher dose (1.0 g q8h) achieved target when MIC was 8 μg/ml.
CONCLUSION


The two-step and extended regimens of imipenem are comparable to the PK/PD target in the treatment of sepsis and septic shock. A higher dose (1.0 g q8h) should be considered for target achievement at an MIC of > 8 μg/ml.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT02616354.",2020,"No significant difference was observed in the percentage of patients achieving 40% T > MIC between the different infusion modes with the same dosage, although the two-step groups exhibited a significantly shorter T max  compared with the extended groups (0.5 g q6h: 1.5 ± 0.8 vs. 2.0 ± 0.0 h; 1.0 g q8h: 1.0 ± 0.6 vs. 2.0 ± 0.0 h; both, p < 0.05).","['Patients with Sepsis and Septic Shock', 'Patients with sepsis and septic shock', 'Thirty-five patients were eventually enrolled']","['Imipenem', 'imipenem']","['plasma imipenem concentrations', 'pharmacokinetic/pharmacodynamic (PK/PD) parameters', 'percentage of patients achieving 40% T\u2009>\u2009MIC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C4319605', 'cui_str': '35'}]","[{'cui': 'C0020933', 'cui_str': 'Imipenem'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0020933', 'cui_str': 'Imipenem'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}]",35.0,0.14188,"No significant difference was observed in the percentage of patients achieving 40% T > MIC between the different infusion modes with the same dosage, although the two-step groups exhibited a significantly shorter T max  compared with the extended groups (0.5 g q6h: 1.5 ± 0.8 vs. 2.0 ± 0.0 h; 1.0 g q8h: 1.0 ± 0.6 vs. 2.0 ± 0.0 h; both, p < 0.05).","[{'ForeName': 'Yingzi', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Pharmacy Department, Hospital for Skin Diseases, Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhan', 'Affiliation': 'Pharmacy Department, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Zha', 'Affiliation': 'Pharmacy Department, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Songqiao', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Shao', 'Affiliation': 'Pharmacy Department, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China. yiyiyang2004@163.com.'}]",Advances in therapy,['10.1007/s12325-020-01339-5']
465,32247311,Community initiated kangaroo mother care and early child development in low birth weight infants in India-a randomized controlled trial.,"BACKGROUND


In a randomized controlled trial (RCT) with 8402 stable low birthweight (LBW) infants, majority being late preterm or term small for gestational age, community-initiated KMC (ciKMC) showed a significant improvement in survival. However, the effect of ciKMC on neurodevelopment is unclear. This is important to elucidate as children born with low birth weight are at high risk of neurodevelopmental deficits. In the first 552 stable LBW infants enrolled in the above trial, we evaluated the effect of ciKMC on neurodevelopmental outcomes during infancy.
METHOD


This RCT was conducted among 552 stable LBW infants, majorly late preterm or term small for gestational age infants without any problems at birth and weighing 1500-2250 g at birth. The intervention comprised of promotion of skin-to-skin contact and exclusive breastfeeding by trained intervention delivery team through home visits. The intervention group mother-infant-dyads were supported to practice ciKMC till day 28 after birth or until the baby wriggled-out. All infants in the intervention and control groups received Home Based Post Natal Care (HBPNC) visits by government health workers. Cognitive, language, motor and socio-emotional outcomes were assessed at infant-ages 6- and 12-months using Bayley Scale of Infant Development (BSID-III). Other outcomes measured were infant temperament, maternal depression, maternal sense of competence, mother-infant bonding and home-environment. We performed post-hoc equivalence testing using two one-sided tests of equivalence (TOST) to provide evidence that ciKMC does not do harm in terms of neurodevelopment.
RESULTS


In the intervention arm, the median (IQR) time to initiate ciKMC was 48 (48 to 72) hours after birth. The mean (SD) duration of skin-to-skin-contact was 27.9 (3.9) days with a mean (SD) of 8.7 (3.5) hours per day. We did not find significant effect of ciKMC on any of the child developmental outcomes during infancy. The TOST analysis demonstrated that composite scores for cognitive, language and motor domains at 12 months among the study arms were statistically equivalent.
CONCLUSION


Our study was unable to capture any effect of ciKMC on neurodevelopment during infancy in this sample of stable late preterm or term small for gestational age infants. Long term follow-up may provide meaningful insights.
TRIAL REGISTRATION


The trial is registered at clinicaltrials.gov NCT02631343 dated February 17, 2016; Retrospectively registered.",2020,All infants in the intervention and control groups received Home Based Post Natal Care (HBPNC) visits by government health workers.,"['children born with low birth weight', '552 stable LBW infants enrolled in the above trial', 'low birth weight infants in India', 'stable late preterm or term small for gestational age infants', 'registered at clinicaltrials.gov NCT02631343 dated February 17, 2016; Retrospectively registered', '552 stable LBW infants, majorly late preterm or term small for gestational age infants without any problems at birth and weighing 1500-2250\u2009g at birth']","['Home Based Post Natal Care (HBPNC) visits by government health workers', 'ciKMC', 'promotion of skin-to-skin contact and exclusive breastfeeding by trained intervention delivery team through home visits']","['neurodevelopmental outcomes', 'Cognitive, language, motor and socio-emotional outcomes', 'mean (SD) duration of skin-to-skin-contact', 'survival', 'composite scores for cognitive, language and motor domains', 'median (IQR) time to initiate ciKMC', 'Bayley Scale of Infant Development (BSID-III', 'infant temperament, maternal depression, maternal sense of competence, mother-infant bonding and home-environment']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021288', 'cui_str': 'Low birth weight infant'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021296', 'cui_str': 'Small-for-dates baby'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C4517582', 'cui_str': '1500'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}]","[{'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",8402.0,0.162231,All infants in the intervention and control groups received Home Based Post Natal Care (HBPNC) visits by government health workers.,"[{'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Taneja', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, 45, Kalu Sarai, New Delhi, 110016, India. sunita.taneja@sas.org.in.'}, {'ForeName': 'Bireshwar', 'Initials': 'B', 'LastName': 'Sinha', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, 45, Kalu Sarai, New Delhi, 110016, India.'}, {'ForeName': 'Ravi Prakash', 'Initials': 'RP', 'LastName': 'Upadhyay', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, 45, Kalu Sarai, New Delhi, 110016, India.'}, {'ForeName': 'Sarmila', 'Initials': 'S', 'LastName': 'Mazumder', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, 45, Kalu Sarai, New Delhi, 110016, India.'}, {'ForeName': 'Halvor', 'Initials': 'H', 'LastName': 'Sommerfelt', 'Affiliation': 'Centre for Intervention Science in Maternal and Child Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Martines', 'Affiliation': 'Centre for Intervention Science in Maternal and Child Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Suresh Kumar', 'Initials': 'SK', 'LastName': 'Dalpath', 'Affiliation': 'State Health System Resource Centre, Haryana, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of School Education, Government of Haryana, Panchkula, India.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Kariger', 'Affiliation': 'Center for Effective Global Health, University of California, Berkeley, USA.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Bahl', 'Affiliation': 'Department of Maternal, Newborn, Child and Adolescent Health, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Nita', 'Initials': 'N', 'LastName': 'Bhandari', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, 45, Kalu Sarai, New Delhi, 110016, India.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Dua', 'Affiliation': 'Department of Mental Health and Substance Abuse, World Health Organization, Geneva, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC pediatrics,['10.1186/s12887-020-02046-4']
466,32277388,Comparative Study to Evaluate Tolerability of Topical 5% Minoxidil Novel Formulation and Alcohol-Based Conventional Solutions in Treatment of Androgenetic Alopecia in Indian Men: Randomized Double-Blind Study.,"INTRODUCTION


Patients with androgenetic alopecia treated with alcohol-based minoxidil topical solutions often report local irritation, dryness, and redness of the scalp. We evaluate the in-use tolerance of 5% minoxidil novel formulation topical solution-test product (TP)-compared with 5% minoxidil alcohol-based topical solutions-reference product 1 (RP1) and reference product 2 (RP2)-in Indian men with androgenetic alopecia.
METHODS


In this randomized double-blind study, patients aged ≥ 18 years with androgenetic alopecia were randomized 1:1:1 to apply TP, RP1, and RP2 twice daily for 30 days. The safety endpoints included mean hydration, mean redness, and mean scaling on scalp.
RESULTS


All screened patients (N = 100) were enrolled and randomized to TP (n = 33), RP1 (n = 33), or RP2 (n = 34). At day 30, the mean (SD) hydration was significantly increased in patients treated with TP [9.74 (4.98)] but significantly reduced in patients treated with RP1 [3.28 (2.67)] or RP2 [3.03 (1.57)] (p-value 0.001). The mean (SD) score for redness was significantly decreased in the TP group [0.01 (0.04)], (p-value, 0.009) at day 30 compared with baseline, while no change was observed in the RP1 [0.08 (0.13)] or RP2 [0.11 (0.17)] group. After 30 days of treatment, no significant difference was observed in the mean score of scaling in any of the three groups.
CONCLUSIONS


Twice daily application of 5% minoxidil novel formulation for 30 days significantly improved hydration and reduced redness of the scalp. Hence, 5% minoxidil novel formulation could be a safer alternative in treating men with androgenetic alopecia who are sensitive to alcoholic formulations.
TRIAL REGISTRATION


Clinical Trial Registry of India; CTRI/2018/11/016431.",2020,"After 30 days of treatment, no significant difference was observed in the mean score of scaling in any of the three groups.
","['Indian men with androgenetic alopecia', 'men with androgenetic alopecia who are sensitive to alcoholic formulations', 'Patients with androgenetic alopecia treated with', 'All screened patients (N\u2009=\u2009100', '18\xa0years with androgenetic alopecia', 'patients aged\u2009≥', 'Indian Men']","['minoxidil', 'alcohol-based minoxidil topical solutions', 'TP', 'Topical 5% Minoxidil Novel Formulation and Alcohol-Based Conventional Solutions', 'minoxidil novel formulation topical solution-test product (TP)-compared with 5% minoxidil alcohol-based topical solutions-reference product 1 (RP1) and reference product 2 (RP2)-in']","['hydration and reduced redness of the scalp', 'mean (SD) score for redness', 'mean score of scaling', 'mean hydration, mean redness, and mean scaling on scalp', 'mean (SD) hydration', 'Androgenetic Alopecia']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0332324', 'cui_str': 'Sensitive'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0307514', 'cui_str': 'Minoxidil Topical Solution [Rogaine]'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0991555', 'cui_str': 'Cutaneous solution'}]","[{'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}]",100.0,0.0681424,"After 30 days of treatment, no significant difference was observed in the mean score of scaling in any of the three groups.
","[{'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Sarkar', 'Affiliation': 'Department of Dermatology, Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Vartak', 'Affiliation': 'C.L.A.I.M.S. Pvt Ltd, Mumbai, Maharashtra, India.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Acharya', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Nikhil Kumar', 'Initials': 'NK', 'LastName': 'Kursam', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Amey', 'Initials': 'A', 'LastName': 'Mane', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Suyog', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Sujeet Narayan', 'Initials': 'SN', 'LastName': 'Charugulla', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India. sujeetnc@drreddys.com.""}]",Dermatology and therapy,['10.1007/s13555-020-00374-y']
467,32231295,A randomized proof-of-mechanism trial applying the 'fast-fail' approach to evaluating κ-opioid antagonism as a treatment for anhedonia.,"The National Institute of Mental Health (NIMH) 'fast-fail' approach seeks to improve too-often-misleading early-phase drug development methods by incorporating biomarker-based proof-of-mechanism (POM) testing in phase 2a. This first comprehensive application of the fast-fail approach evaluated the potential of κ-opioid receptor (KOR) antagonism for treating anhedonia with a POM study determining whether robust target engagement favorably impacts the brain circuitry hypothesized to mediate clinical effects. Here we report the results from a multicenter, 8-week, double-blind, placebo-controlled, randomized trial in patients with anhedonia and a mood or anxiety disorder (selective KOR antagonist (JNJ-67953964, 10 mg; n = 45) and placebo (n = 44)). JNJ-67953964 significantly increased functional magnetic resonance imaging (fMRI) ventral striatum activation during reward anticipation (primary outcome) as compared to placebo (baseline-adjusted mean: JNJ-67953964, 0.72 (s.d. = 0.67); placebo, 0.33 (s.d. = 0.68); F(1,86) = 5.58, P < 0.01; effect size = 0.58 (95% confidence interval, 0.13-0.99)). JNJ-67953964, generally well tolerated, was not associated with any serious adverse events. This study supports proceeding with assessment of the clinical impact of target engagement and serves as a model for implementing the 'fast-fail' approach.",2020,"significantly increased functional magnetic resonance imaging (fMRI) ventral striatum activation during reward anticipation (primary outcome) as compared to placebo (baseline-adjusted mean: JNJ-67953964, 0.72 (s.d. = 0.67); placebo, 0.33 (s.d. = 0.68); F(1,86) = 5.58, P < 0.01; effect size = 0.58 (95% confidence interval, 0.13-0.99)).","['patients with anhedonia and a mood or anxiety disorder (selective KOR antagonist (JNJ-67953964, 10\u2009mg; n\u2009=\u200945) and', 'n\u2009=\u200944']","['placebo', 'κ-opioid receptor (KOR) antagonism', 'JNJ-67953964']","['serious adverse events', 'functional magnetic resonance imaging (fMRI) ventral striatum activation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0034801', 'cui_str': 'Receptors, Opiate'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0750950', 'cui_str': 'Ventral Striatum'}]",,0.474631,"significantly increased functional magnetic resonance imaging (fMRI) ventral striatum activation during reward anticipation (primary outcome) as compared to placebo (baseline-adjusted mean: JNJ-67953964, 0.72 (s.d. = 0.67); placebo, 0.33 (s.d. = 0.68); F(1,86) = 5.58, P < 0.01; effect size = 0.58 (95% confidence interval, 0.13-0.99)).","[{'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco, CA, USA. andrew.krystal@ucsf.edu.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'McLean Hospital, Harvard Medical School, Belmont, MA, USA.'}, {'ForeName': 'Moria', 'Initials': 'M', 'LastName': 'Smoski', 'Affiliation': 'Departments of Psychiatry and Behavioral Sciences and Radiology, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Sanjay J', 'Initials': 'SJ', 'LastName': 'Mathew', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nurnberger', 'Affiliation': 'Departments of Psychiatry and Neurobiology, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Lisanby', 'Affiliation': 'National Institute of Mental Health, Bethesda, MD, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Iosifescu', 'Affiliation': 'Department of Psychiatry, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Murrough', 'Affiliation': 'Department of Psychiatry and Neuroscience, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Hongqiu', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Weiner', 'Affiliation': 'Departments of Psychiatry and Behavioral Sciences and Radiology, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': 'Department of Psychiatry, Case Western Reserve School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Hermes', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Richard S E', 'Initials': 'RSE', 'LastName': 'Keefe', 'Affiliation': 'Departments of Psychiatry and Behavioral Sciences and Radiology, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Song', 'Affiliation': 'Departments of Psychiatry and Behavioral Sciences and Radiology, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Goodman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Steven T', 'Initials': 'ST', 'LastName': 'Szabo', 'Affiliation': 'Departments of Psychiatry and Behavioral Sciences and Radiology, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Alexis E', 'Initials': 'AE', 'LastName': 'Whitton', 'Affiliation': 'McLean Hospital, Harvard Medical School, Belmont, MA, USA.'}, {'ForeName': 'Keming', 'Initials': 'K', 'LastName': 'Gao', 'Affiliation': 'Department of Psychiatry, Case Western Reserve School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'William Z', 'Initials': 'WZ', 'LastName': 'Potter', 'Affiliation': 'National Institute of Mental Health, Bethesda, MD, USA.'}]",Nature medicine,['10.1038/s41591-020-0806-7']
468,32107773,Home fortification of foods with multiple micronutrient powders for health and nutrition in children under two years of age.,"BACKGROUND


Vitamin and mineral deficiencies, particularly those of iron, vitamin A, and zinc, affect more than two billion people worldwide. Young children are highly vulnerable because of rapid growth and inadequate dietary practices. Multiple micronutrient powders (MNPs) are single-dose packets containing multiple vitamins and minerals in powder form, which are mixed into any semi-solid food for children six months of age or older. The use of MNPs for home or point-of-use fortification of complementary foods has been proposed as an intervention for improving micronutrient intake in children under two years of age. In 2014, MNP interventions were implemented in 43 countries and reached over three million children. This review updates a previous Cochrane Review, which has become out-of-date.
OBJECTIVES


To assess the effects and safety of home (point-of-use) fortification of foods with MNPs on nutrition, health, and developmental outcomes in children under two years of age. For the purposes of this review, home fortification with MNP refers to the addition of powders containing vitamins and minerals to semi-solid foods immediately before consumption. This can be done at home or at any other place that meals are consumed (e.g. schools, refugee camps). For this reason, MNPs are also referred to as point-of-use fortification.
SEARCH METHODS


We searched the following databases up to July 2019: CENTRAL, MEDLINE, Embase, and eight other databases. We also searched four trials registers, contacted relevant organisations and authors of included studies to identify any ongoing or unpublished studies, and searched the reference lists of included studies.
SELECTION CRITERIA


We included randomised controlled trials (RCTs) and quasi-RCTs with individual randomisation or cluster-randomisation. Participants were infants and young children aged 6 to 23 months at the time of intervention, with no identified specific health problems. The intervention consisted of consumption of food fortified at the point of use with MNP formulated with at least iron, zinc, and vitamin A, compared with placebo, no intervention, or use of iron-containing supplements, which is standard practice.
DATA COLLECTION AND ANALYSIS


Two review authors independently assessed the eligibility of studies against the inclusion criteria, extracted data from included studies, and assessed the risk of bias of included studies. We reported categorical outcomes as risk ratios (RRs) or odds ratios (ORs), with 95% confidence intervals (CIs), and continuous outcomes as mean differences (MDs) and 95% CIs. We used the GRADE approach to assess the certainty of evidence.
MAIN RESULTS


We included 29 studies (33,147 children) conducted in low- and middle-income countries in Asia, Africa, Latin America, and the Caribbean, where anaemia is a public health problem. Twenty-six studies with 27,051 children contributed data. The interventions lasted between 2 and 44 months, and the powder formulations contained between 5 and 22 nutrients. Among the 26 studies contributing data, 24 studies (26,486 children) compared the use of MNP versus no intervention or placebo; the two remaining studies compared the use of MNP versus an iron-only supplement (iron drops) given daily. The main outcomes of interest were related to anaemia and iron status. We assessed most of the included studies at low risk of selection and attrition bias. We considered some studies to be at high risk of performance and detection bias due to lack of blinding. Most studies were funded by government programmes or foundations; only two were funded by industry. Home fortification with MNP, compared with no intervention or placebo, reduced the risk of anaemia in infants and young children by 18% (RR 0.82, 95% CI 0.76 to 0.90; 16 studies; 9927 children; moderate-certainty evidence) and iron deficiency by 53% (RR 0.47, 95% CI 0.39 to 0.56; 7 studies; 1634 children; high-certainty evidence). Children receiving MNP had higher haemoglobin concentrations (MD 2.74 g/L, 95% CI 1.95 to 3.53; 20 studies; 10,509 children; low-certainty evidence) and higher iron status (MD 12.93 μg/L, 95% CI 7.41 to 18.45; 7 studies; 2612 children; moderate-certainty evidence) at follow-up compared with children receiving the control intervention. We did not find an effect on weight-for-age (MD 0.02, 95% CI -0.03 to 0.07; 10 studies; 9287 children; moderate-certainty evidence). Few studies reported morbidity outcomes (three to five studies each outcome) and definitions varied, but MNP did not increase diarrhoea, upper respiratory infection, malaria, or all-cause morbidity. In comparison with daily iron supplementation, the use of MNP produced similar results for anaemia (RR 0.89, 95% CI 0.58 to 1.39; 1 study; 145 children; low-certainty evidence) and haemoglobin concentrations (MD -2.81 g/L, 95% CI -10.84 to 5.22; 2 studies; 278 children; very low-certainty evidence) but less diarrhoea (RR 0.52, 95% CI 0.38 to 0.72; 1 study; 262 children; low-certainty of evidence). However, given the limited quantity of data, these results should be interpreted cautiously. Reporting of death was infrequent, although no trials reported deaths attributable to the intervention. Information on side effects and morbidity, including malaria and diarrhoea, was scarce. It appears that use of MNP is efficacious among infants and young children aged 6 to 23 months who are living in settings with different prevalences of anaemia and malaria endemicity, regardless of intervention duration. MNP intake adherence was variable and in some cases comparable to that achieved in infants and young children receiving standard iron supplements as drops or syrups.
AUTHORS' CONCLUSIONS


Home fortification of foods with MNP is an effective intervention for reducing anaemia and iron deficiency in children younger than two years of age. Providing MNP is better than providing no intervention or placebo and may be comparable to using daily iron supplementation. The benefits of this intervention as a child survival strategy or for developmental outcomes are unclear. Further investigation of morbidity outcomes, including malaria and diarrhoea, is needed. MNP intake adherence was variable and in some cases comparable to that achieved in infants and young children receiving standard iron supplements as drops or syrups.",2020,"Children receiving MNP had higher haemoglobin concentrations (MD 2.74 g/L, 95% CI 1.95 to 3.53; 20 studies; 10,509 children; low-certainty evidence) and higher iron status (MD 12.93 μg/L, 95% CI 7.41 to 18.45; 7 studies; 2612 children; moderate-certainty evidence) at follow-up compared with children receiving the control intervention.","['29 studies (33,147 children) conducted in low- and middle-income countries in Asia, Africa, Latin America, and the Caribbean, where anaemia is a public health problem', 'children under two years of age', 'infants and young children aged 6 to 23 months who are living in settings with different prevalences of anaemia and malaria endemicity, regardless of intervention duration', 'children six months of age or older', 'children younger than two years of age', 'Young children', 'Participants were infants and young children aged 6 to 23 months at the time of intervention, with no identified specific health problems']","['placebo', 'foods with MNPs', 'Home fortification of foods with multiple micronutrient powders', 'consumption of food fortified at the point of use with MNP formulated with at least iron, zinc, and vitamin A, compared with placebo, no intervention, or use of iron-containing supplements', 'MNP']","['risk of anaemia', 'MNP intake adherence', 'anaemia and iron deficiency', 'morbidity outcomes', 'Reporting of death', 'diarrhoea', 'side effects and morbidity, including malaria and diarrhoea', 'anaemia', 'haemoglobin concentrations', 'malaria and diarrhoea', 'diarrhoea, upper respiratory infection, malaria, or all-cause morbidity', 'anaemia and iron status', 'risk ratios (RRs) or odds ratios (ORs), with 95% confidence intervals (CIs), and continuous outcomes']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0023122', 'cui_str': 'Latin America'}, {'cui': 'C0206155', 'cui_str': 'West Indies Region'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0240066', 'cui_str': 'Iron deficiency (disorder)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]",145.0,0.520698,"Children receiving MNP had higher haemoglobin concentrations (MD 2.74 g/L, 95% CI 1.95 to 3.53; 20 studies; 10,509 children; low-certainty evidence) and higher iron status (MD 12.93 μg/L, 95% CI 7.41 to 18.45; 7 studies; 2612 children; moderate-certainty evidence) at follow-up compared with children receiving the control intervention.","[{'ForeName': 'Parminder S', 'Initials': 'PS', 'LastName': 'Suchdev', 'Affiliation': 'Emory University, Department of Pediatrics, 1760 Haygood Dr, Atlanta, GA, USA, 30322.'}, {'ForeName': 'Maria Elena D', 'Initials': 'MED', 'LastName': 'Jefferds', 'Affiliation': 'Centers for Disease Control and Prevention, Nutrition Branch, Division of Nutrition, Physical Activity, and Obesity, Atlanta, GA, USA.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Ota', 'Affiliation': ""St. Luke's International University, Global Health Nursing, Graduate School of Nursing Science, 10-1 Akashi-cho, Chuo-Ku, Tokyo, MS, Japan, 104-0044.""}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'da Silva Lopes', 'Affiliation': ""St. Luke's International University, Graduate School of Public Health, 3-6-2 Tsukiji, Chuo-Ku, Tokyo, MS, Japan, 104-0045.""}, {'ForeName': 'Luz Maria', 'Initials': 'LM', 'LastName': 'De-Regil', 'Affiliation': 'LMD int, 2030 Alton St, Ottawa, ON, Canada, K1G 1X4.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD008959.pub3']
469,31652094,Randomized Trial of Lenalidomide Versus Observation in Smoldering Multiple Myeloma.,"PURPOSE


Observation is the current standard of care for smoldering multiple myeloma. We hypothesized that early intervention with lenalidomide could delay progression to symptomatic multiple myeloma.
METHODS


We conducted a randomized trial that assessed the efficacy of single-agent lenalidomide compared with observation in patients with intermediate- or high-risk smoldering multiple myeloma. Lenalidomide was administered orally at a dose of 25 mg on days 1 to 21 of a 28-day cycle. The primary end point was progression-free survival, with disease progression requiring the development of end-organ damage attributable to multiple myeloma and biochemical progression.
RESULTS


One hundred eighty-two patients were randomly assigned-92 patients to the lenalidomide arm and 90 to the observation arm. Median follow-up is 35 months. Response to therapy was observed in 50% (95% CI, 39% to 61%) of patients in the lenalidomide arm, with no responses in the observation arm. Progression-free survival was significantly longer with lenalidomide compared with observation (hazard ratio, 0.28; 95% CI, 0.12 to 0.62;  P  = .002). One-, 2-, and 3-year progression-free survival was 98%, 93%, and 91% for the lenalidomide arm versus 89%, 76%, and 66% for the observation arm, respectively. Only six deaths have been reported, two in the lenalidomide arm versus four in the observation arm (hazard ratio for death, 0.46; 95% CI, 0.08 to 2.53). Grade 3 or 4 nonhematologic adverse events occurred in 25 patients (28%) on lenalidomide.
CONCLUSION


Early intervention with lenalidomide in smoldering multiple myeloma significantly delays progression to symptomatic multiple myeloma and the development of end-organ damage.",2020,"Progression-free survival was significantly longer with lenalidomide compared with observation (hazard ratio, 0.28; 95% CI, 0.12 to 0.62;  ","['Smoldering Multiple Myeloma', 'patients with intermediate- or high-risk smoldering multiple myeloma', 'One hundred eighty-two patients were randomly assigned-92 patients to the lenalidomide arm and 90 to the observation arm']","['single-agent lenalidomide', 'lenalidomide', 'Lenalidomide']","['progression-free survival, with disease progression requiring the development of end-organ damage attributable to multiple myeloma and biochemical progression', '3-year progression-free survival', 'Progression-free survival', 'Grade 3 or 4 nonhematologic adverse events']","[{'cui': 'C1531608', 'cui_str': 'Asymptomatic Multiple Myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",182.0,0.116764,"Progression-free survival was significantly longer with lenalidomide compared with observation (hazard ratio, 0.28; 95% CI, 0.12 to 0.62;  ","[{'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Lonial', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Jacobus', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Fonseca', 'Affiliation': 'Mayo Clinic, Scottsdale, AZ.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'ThedaCare Cancer Center, Appleton, WI.'}, {'ForeName': 'Shaji', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Robert Z', 'Initials': 'RZ', 'LastName': 'Orlowski', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Kaufman', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'Abdulraheem M', 'Initials': 'AM', 'LastName': 'Yacoub', 'Affiliation': 'University of Kansas Cancer Center, Westwood, KS.'}, {'ForeName': 'Francis K', 'Initials': 'FK', 'LastName': 'Buadi', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': ""O'Brien"", 'Affiliation': 'MetroHealth Medical Center, Cleveland, OH.'}, {'ForeName': 'Jeffrey V', 'Initials': 'JV', 'LastName': 'Matous', 'Affiliation': 'Colorado Blood Cancer Institute and Sarah Cannon Research Institute, Denver, CO.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Anderson', 'Affiliation': 'Park Nicollet Clinic, Saint Louis Park, MN.'}, {'ForeName': 'Robert V', 'Initials': 'RV', 'LastName': 'Emmons', 'Affiliation': 'University of Louisville, Louisville, KY.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Mahindra', 'Affiliation': 'Scripps Clinic Torrey Pines, La Jolla, CA.'}, {'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Wake Forest University Health Sciences, Winston-Salem, NC.'}, {'ForeName': 'Madhav V', 'Initials': 'MV', 'LastName': 'Dhodapkar', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'S Vincent', 'Initials': 'SV', 'LastName': 'Rajkumar', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01740']
470,31466614,Effects of Alirocumab on Cardiovascular Events After Coronary Bypass Surgery.,"BACKGROUND


Patients with acute coronary syndrome (ACS) and history of coronary artery bypass grafting (CABG) are at high risk for recurrent cardiovascular events and death.
OBJECTIVES


This study sought to determine the clinical benefit of adding alirocumab to statins in ACS patients with prior CABG in a pre-specified analysis of ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab).
METHODS


Patients (n = 18,924) 1 to 12 months post-ACS with elevated atherogenic lipoprotein levels despite high-intensity statin therapy were randomized to alirocumab or placebo subcutaneously every 2 weeks. Median follow-up was 2.8 years. The primary composite endpoint of major adverse cardiovascular events (MACE) comprised coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, or unstable angina requiring hospitalization. All-cause death was a secondary endpoint. Patients were categorized by CABG status: no CABG (n = 16,896); index CABG after qualifying ACS, but before randomization (n = 1,025); or CABG before the qualifying ACS (n = 1,003).
RESULTS


In each CABG category, hazard ratios (95% confidence intervals) for MACE (no CABG 0.86 [0.78 to 0.95], index CABG 0.85 [0.54 to 1.35], prior CABG 0.77 [0.61 to 0.98]) and death (0.88 [0.75 to 1.03], 0.85 [0.46 to 1.59], 0.67 [0.44 to 1.01], respectively) were consistent with the overall trial results (0.85 [0.78 to 0.93] and 0.85 [0.73 to 0.98], respectively). Absolute risk reductions (95% confidence intervals) differed across CABG categories for MACE (no CABG 1.3% [0.5% to 2.2%], index CABG 0.9% [-2.3% to 4.0%], prior CABG 6.4% [0.9% to 12.0%]) and for death (0.4% [-0.1% to 1.0%], 0.5% [-1.9% to 2.9%], and 3.6% [0.0% to 7.2%]).
CONCLUSIONS


Among patients with recent ACS and elevated atherogenic lipoproteins despite intensive statin therapy, alirocumab was associated with large absolute reductions in MACE and death in those with CABG preceding the ACS event. (ODYSSEY OUTCOMES: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab; NCT01663402).",2019,"Absolute risk reductions (95% confidence intervals) differed across CABG categories for MACE (no CABG 1.3% [0.5% to 2.2%], index CABG 0.9% [","['Acute Coronary Syndrome', 'ACS patients with prior CABG', 'Patients (n\xa0', 'Patients were categorized by CABG status', 'Patients with acute coronary syndrome (ACS) and history of coronary artery bypass grafting (CABG']","['Alirocumab', 'alirocumab to statins', 'alirocumab or placebo']","['index CABG', 'atherogenic lipoprotein levels', 'CABG categories for MACE', 'Cardiovascular Events', 'major adverse cardiovascular events (MACE) comprised coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, or unstable angina requiring hospitalization', 'death', 'hazard ratios', 'Absolute risk reductions']","[{'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1275842', 'cui_str': 'Past history of coronary artery bypass grafting'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}]",,0.0698925,"Absolute risk reductions (95% confidence intervals) differed across CABG categories for MACE (no CABG 1.3% [0.5% to 2.2%], index CABG 0.9% [","[{'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada and St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada. Electronic address: goodmans@smh.ca.""}, {'ForeName': 'Philip E', 'Initials': 'PE', 'LastName': 'Aylward', 'Affiliation': 'South Australian Health and Medical Research Institute, Flinders University and Medical Centre, Adelaide, South Australia, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'State University of New York, Downstate School of Public Health, Brooklyn, New York.'}, {'ForeName': 'Vakhtang', 'Initials': 'V', 'LastName': 'Chumburidze', 'Affiliation': 'Chapidze Emergency Cardiology Center, Tbilisi, Georgia.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Cardiológicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina.'}, {'ForeName': 'Jay M', 'Initials': 'JM', 'LastName': 'Edelberg', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Hanotin', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Harrington', 'Affiliation': 'Stanford Center for Clinical Research, Department of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Sasko', 'Initials': 'S', 'LastName': 'Kedev', 'Affiliation': 'University Clinic of Cardiology, Skopje, Macedonia.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Letierce', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Angele', 'Initials': 'A', 'LastName': 'Moryusef', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, New York.'}, {'ForeName': 'Gabriel Arturo', 'Initials': 'GA', 'LastName': 'Ramos López', 'Affiliation': 'Medical Office, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina; Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Margus', 'Initials': 'M', 'LastName': 'Viigimaa', 'Affiliation': 'SA Põhja-Eesti Regionaalhaigla, Tallinn, Estonia.'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Ph Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Paris, France; National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.07.015']
471,32252167,Effect of the Presence and Type of Plate Augmentation on Postoperative Dysphagia Among Adult Patients Undergoing Elective Anterior Cervical Discectomy and Fusion for Spondylosis: A Randomized Trial.,"OBJECTIVE


To determine the effect of anterior plating on postoperative dysphagia (POD) among adult patients undergoing elective anterior cervical discectomy and fusion (ACDF) for cervical spondylosis and determine the potential role of demographic and clinical characteristics in the development of POD.
METHODS


Consecutive adults undergoing an elective, single-level, ACDF were randomly assigned to receive a stand-alone CoRoent Cage or a CoRoent Cage with a Helix, or HelixMini plate. Patients with a history of cervical spine surgery were excluded. M. D. Anderson Dysphagia Inventory and Bazaz questionnaires were completed at regular intervals for 12 months postoperatively.
RESULTS


Twenty-five patients were recruited over a 2-year period, with 8 allocated to receive a stand-alone cage, 5 to receive a cage and Helix Mini plate, and 12 to receive a cage and Helix plate. The POD rate was 68% at 48 hours, before falling to 16% at 6 and 12 months. A longer retraction time was observed in the Helix plate group compared to the stand-alone cage group (7.88; 95% confidence interval, 0.12-15.63; p = 0.046), although there was no difference in the incidence or severity of dysphagia between cohorts at any timepoint. With the exception of body mass index, there was no difference in patients with and without dysphagia, and each of the interventions was equally efficacious with respect to clinical and radiological endpoints.
CONCLUSION


Dysphagia is a common consequence of ACDF and, while the placement of a large plate results in longer retraction time, it was not associated with higher rates of dysphagia. Further research is required to identify both patient-specific and surgical contributors to this complication.",2020,"A longer retraction time was observed in the Helix plate group compared to the stand-alone cage group (7.88; 95% confidence interval, 0.12-15.63; p = 0.046), although there was no difference in the incidence or severity of dysphagia between cohorts at any timepoint.","['Patients with a history of cervical spine surgery', 'adult patients undergoing', 'Adult Patients Undergoing Elective Anterior Cervical Discectomy and Fusion for Spondylosis', 'Twenty-five patients were recruited over a 2-year period', 'Consecutive adults undergoing an elective, single-level, ACDF']","['stand-alone CoRoent Cage or a CoRoent Cage with a Helix, or HelixMini plate', 'stand-alone cage, 5 to receive a cage and Helix Mini plate, and 12 to receive a cage and Helix plate', 'Plate Augmentation', 'anterior plating', 'elective anterior cervical discectomy and fusion (ACDF']","['Postoperative Dysphagia', 'incidence or severity of dysphagia', 'POD rate', 'M. D. Anderson Dysphagia Inventory and Bazaz questionnaires', 'longer retraction time', 'rates of dysphagia', 'postoperative dysphagia (POD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1997458', 'cui_str': 'History of surgical procedure on cervical spine'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0038019', 'cui_str': 'Spondylosis'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4552416', 'cui_str': 'ACDF'}]","[{'cui': 'C0560204', 'cui_str': 'Does stand alone'}, {'cui': 'C0337189', 'cui_str': 'Cage'}, {'cui': 'C0018882', 'cui_str': 'Helix'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C4552416', 'cui_str': 'ACDF'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",25.0,0.101666,"A longer retraction time was observed in the Helix plate group compared to the stand-alone cage group (7.88; 95% confidence interval, 0.12-15.63; p = 0.046), although there was no difference in the incidence or severity of dysphagia between cohorts at any timepoint.","[{'ForeName': 'Tom J', 'Initials': 'TJ', 'LastName': ""O'Donohoe"", 'Affiliation': ""Department of Neurosurgery, St. Vincent's Hospital, Fitzroy, VIC, Australia.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Mililli', 'Affiliation': 'Keyhole Neurosurgery, Fitzroy, VIC, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Magee', 'Affiliation': 'Keyhole Neurosurgery, Fitzroy, VIC, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Thien', 'Affiliation': ""Department of Neurosurgery, St. Vincent's Hospital, Fitzroy, VIC, Australia.""}, {'ForeName': 'Yi Yuen', 'Initials': 'YY', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosurgery, St. Vincent's Hospital, Fitzroy, VIC, Australia.""}]",Neurospine,['10.14245/ns.1938446.223']
472,32001481,FDA Approval Summary: Atezolizumab Plus Paclitaxel Protein-bound for the Treatment of Patients with Advanced or Metastatic TNBC Whose Tumors Express PD-L1.,"On March 8, 2019, the FDA granted accelerated approval to atezolizumab in combination with paclitaxel protein-bound for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 [PD-L1 stained tumor-infiltrating immune cells (IC) of any intensity covering ≥1% of the tumor area], as determined by an FDA-approved test. Approval was based on data from IMpassion130, which randomized patients to receive atezolizumab or placebo in combination with paclitaxel protein-bound. Investigator-assessed progression-free survival (PFS) in the intent-to-treat (ITT) and PD-L1-positive populations were coprimary endpoints. After 13-month median follow-up, the estimated median PFS in the PD-L1-positive population was 7.4 months in the atezolizumab arm and 4.8 months in the placebo arm [HR = 0.60; 95% confidence interval (CI), 0.48-0.77]. Overall survival (OS) results were immature with 43% deaths in the ITT population, representing 59% of the OS events required to perform the final OS analysis. Adverse reactions occurring in ≥20% of patients receiving atezolizumab with paclitaxel protein-bound were alopecia, peripheral neuropathies, fatigue, nausea, diarrhea, anemia, constipation, cough, headache, neutropenia, vomiting, and decreased appetite. Accelerated approval was appropriate taking into account the unmet medical need along with the immaturity of the OS results and potential for PFS in the PD-L1-expressing population to predict clinical benefit.",2020,Investigator-assessed progression-free survival (PFS) in the intent-to-treat (ITT) and PD-L1-positive populations were co-primary endpoints.,"['patients with advanced or metastatic TNBC whose tumors express PD-L1', 'adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC']","['placebo', 'atezolizumab', 'atezolizumab or placebo']","['median PFS', 'Overall survival results', 'Adverse reactions', 'alopecia, peripheral neuropathies, fatigue, nausea, diarrhea, anemia, constipation, cough, headache, neutropenia, vomiting, and decreased appetite', 'Investigator-assessed progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0589049,Investigator-assessed progression-free survival (PFS) in the intent-to-treat (ITT) and PD-L1-positive populations were co-primary endpoints.,"[{'ForeName': 'Preeti', 'Initials': 'P', 'LastName': 'Narayan', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. preeti.narayan@fda.hhs.gov.'}, {'ForeName': 'Sakar', 'Initials': 'S', 'LastName': 'Wahby', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Gao', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Amiri-Kordestani', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Ibrahim', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Bloomquist', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Shenghui', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Song', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Bellinda L', 'Initials': 'BL', 'LastName': 'King-Kallimanis', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Hou', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Yutao', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Shyam', 'Initials': 'S', 'LastName': 'Kalavar', 'Affiliation': 'Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Soma', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Philip', 'Affiliation': 'Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Goldberg', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Theoret', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Gideon M', 'Initials': 'GM', 'LastName': 'Blumenthal', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Kluetz', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Rajeshwari', 'Initials': 'R', 'LastName': 'Sridhara', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Beaver', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3545']
473,31136202,Heat therapy improves glucose tolerance and adipose tissue insulin signaling in polycystic ovary syndrome.,"Polycystic ovary syndrome (PCOS) is associated with high rates of obesity and metabolic dysfunction. Repeated passive heat exposure (termed heat therapy) is a novel lifestyle intervention for improving health in obese women with PCOS. The purpose of this study was to examine changes in metabolic function in obese women with PCOS following heat therapy. Eighteen age- and BMI-matched obese women with PCOS (age: 27 ± 1 yr, BMI: 41.3 ± 1.1 kg/m -2 ) were assigned to heat therapy (HT) or time control (CON). HT participants underwent 30 one-hour hot tub sessions over 8-10 wk, while CON participants completed all testing but did not undergo heat therapy. Before (Pre), at the mid-point (Mid), and following (Post) 8-10 wk of heat therapy, metabolic health was assessed using a 2-h oral glucose tolerance test, a subcutaneous abdominal fat biopsy (Pre-Post only), and other blood markers relating to metabolic function. HT participants exhibited improved fasting glucose (Pre: 105 ± 3, Post: 89 ± 5mg/dl;  P  = 0.001), glucose area under the curve (AUC) (Pre: 18,698 ± 1,045, Post: 16,987 ± 1,017 mg·dl -1 ·min -1 ;  P  = 0.028) and insulin AUC (Pre: 126,924 ± 11,730, Post: 91,233 ± 14,429 IU l -1 ·min -1 ;  P  = 0.012). Adipocyte insulin signaling (p-AKT at Ser-473 with 1.2 nM insulin) increased in HT (Pre: 0.29 ± 0.14, Post: 0.93 ± 0.29 AU;  P  = 0.021). Additionally, serum testosterone declined in HT participants (Pre: 51 ± 7, Post: 34 ± 4 ng/dl;  P  = 0.033). No parameters changed over time in CON, and no change in BMI was observed in either group. HT substantially improved metabolic risk profile in obese women with PCOS. HT also reduced androgen excess and may improve PCOS symptomology.",2019,"Adipocyte insulin signaling (p-AKT at Ser-473 with 1.2 nM insulin) increased in HT (Pre: 0.29 ± 0.14, Post: 0.93 ± 0.29 AU;  P  = 0.021).","['obese women with PCOS', 'obese women with PCOS following heat therapy', 'polycystic ovary syndrome', 'Polycystic ovary syndrome (PCOS', 'Eighteen age- and BMI-matched obese women with PCOS (age: 27\u2009±']","['Repeated passive heat exposure (termed heat therapy', 'Heat therapy', 'heat therapy (HT) or time control (CON', 'HT']","['metabolic function', 'serum testosterone', 'BMI', 'metabolic risk profile', 'fasting glucose', 'Adipocyte insulin signaling', 'PCOS symptomology', 'glucose area under the curve (AUC', 'time in CON', 'glucose tolerance and adipose tissue insulin signaling']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0150611', 'cui_str': 'Heat therapy (procedure)'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0239930', 'cui_str': 'Exposure to heat (event)'}, {'cui': 'C0150611', 'cui_str': 'Heat therapy (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0206131', 'cui_str': 'Fat Cells'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}]",,0.0948154,"Adipocyte insulin signaling (p-AKT at Ser-473 with 1.2 nM insulin) increased in HT (Pre: 0.29 ± 0.14, Post: 0.93 ± 0.29 AU;  P  = 0.021).","[{'ForeName': 'Brett R', 'Initials': 'BR', 'LastName': 'Ely', 'Affiliation': 'Department of Human Physiology, University of Oregon , Eugene, Oregon.'}, {'ForeName': 'Zachary S', 'Initials': 'ZS', 'LastName': 'Clayton', 'Affiliation': 'Department of Human Physiology, University of Oregon , Eugene, Oregon.'}, {'ForeName': 'Carrie E', 'Initials': 'CE', 'LastName': 'McCurdy', 'Affiliation': 'Department of Human Physiology, University of Oregon , Eugene, Oregon.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Pfeiffer', 'Affiliation': 'PeaceHealth Medical Group, Oregon Bariatric Center , Springfield, Oregon.'}, {'ForeName': 'Karen Wiedenfeld', 'Initials': 'KW', 'LastName': 'Needham', 'Affiliation': 'Department of Human Physiology, University of Oregon , Eugene, Oregon.'}, {'ForeName': 'Lindan N', 'Initials': 'LN', 'LastName': 'Comrada', 'Affiliation': 'Department of Human Physiology, University of Oregon , Eugene, Oregon.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Minson', 'Affiliation': 'Department of Human Physiology, University of Oregon , Eugene, Oregon.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00549.2018']
474,32273054,Trends in Treatment for Patients Hospitalized with Heart Failure with Preserved Ejection Fraction Before and After Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT).,"The TOPCAT trial investigated spironolactone vs placebo in patients with heart failure with preserved ejection fraction (HFpEF). Although the primary endpoint was not statistically significant, treatment with spironolactone did reduce heart failure hospitalizations compared with placebo. TOPCAT's impact on prescribing patterns in the United States is not well-characterized. We performed a retrospective analysis of discharge prescribing data in the Get With The Guidelines-Heart Failure Registry among patients with left ventricular ejection fraction ≥50% discharged between January 2009 and December 2016 to assess prescribing trends upon dissemination of TOPCAT results. Of 142,201 patients included in the study, 18,581 (13.1%) were prescribed mineralocorticoid receptor antagonists (MRAs) at discharge. Compared with those not prescribed MRAs, patients discharged on MRAs were generally younger (75 vs 78 years), and report white race (76.7% vs 72.0%), more likely to have had prior heart failure hospitalizations (75.5% vs 65.7%), lower brain natriuretic peptide levels (492 vs 545 pg/mL), but similar serum creatinine levels (1.2 vs 1.2 mg/dL) upon admission. MRA prescribing modestly increased over time (p <0.0001), without significant change in the overall trend of prescribing rate for MRAs after TOPCAT results were presented (p =0.17). In conclusion, our findings suggest that for patients with HFpEF, the use of MRAs at hospital discharge is low, with only modest increases over time and no discernible change in the rate of MRA use after the TOPCAT results were released. There remains an important need for more clinical trials to better establish the efficacy and safety of MRAs for the treatment of HFpEF.",2020,"MRA prescribing modestly increased over time (p <0.0001), without significant change in the overall trend of prescribing rate for MRAs after TOPCAT results were presented (p =0.17).","['Patients Hospitalized with Heart Failure with Preserved Ejection Fraction Before and After Treatment of Preserved Cardiac Function Heart Failure With an', 'patients with heart failure with preserved ejection fraction (HFpEF', 'patients with left ventricular ejection fraction', 'Of 142,201 patients included in the study, 18,581 (13.1%) were prescribed mineralocorticoid receptor antagonists (MRAs) at discharge']","['Aldosterone Antagonist (TOPCAT', 'placebo', 'spironolactone', 'spironolactone vs placebo']","['prescribing rate for MRAs', 'serum creatinine levels', 'heart failure hospitalizations', 'lower brain natriuretic peptide levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}]","[{'cui': 'C0002007', 'cui_str': 'Aldosterone receptor antagonist-containing product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement'}]",142201.0,0.103052,"MRA prescribing modestly increased over time (p <0.0001), without significant change in the overall trend of prescribing rate for MRAs after TOPCAT results were presented (p =0.17).","[{'ForeName': 'Marat', 'Initials': 'M', 'LastName': 'Fudim', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Jacob P', 'Initials': 'JP', 'LastName': 'Kelly', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Brophy', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute and Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Bradley G', 'Initials': 'BG', 'LastName': 'Hammill', 'Affiliation': 'Duke Clinical Research Institute and Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute and Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Clyde', 'Initials': 'C', 'LastName': 'Yancy', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Ahmanson-UCLA Cardiomyopathy Center, University of California Los Angeles Medical Center, Los Angeles, California.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute and Duke University Medical Center, Durham, North Carolina. Electronic address: adrian.hernandez@duke.edu.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.02.038']
475,32272287,Short interval or continuous training programs to improve walking distance for intermittent claudication: Pilot study.,"OBJECTIVE


Supervised exercise training is part of first-line therapies for intermittent claudication. Short periods of intensive treadmill training have been found efficient; however, the optimal modalities remain to be determined, especially interval training with active recovery (ITAR). In this prospective assessor-blinded single-centre pilot study, we assessed the feasibility of a randomised controlled trial comparing parallel 4-week intensive rehabilitation programs comprising treadmill training performed as ITAR or conventional training with constant slope and speed interspersed with rest periods (CT).
METHODS


A total of 38 in- or out-patients were randomised to the ITAR or CT program for 5 days/week for 4weeks. The primary outcome was change in maximum walking distance measured on a graded treadmill before and after the program.
RESULTS


Adherence was high. All training sessions were completed in the ITAR program and only a few were not completed in the CT program (median 100% [Q1-Q3 96-100]). Tolerance was excellent (no adverse events). VO 2peak  was low in both groups, corresponding to moderate to severe exercise intolerance. The 2 groups did not differ in the primary outcome (median ITAR vs CT 480 [135-715] vs 315m [0-710]; p=0.62) or other walking distances (constant speed and gradient treadmill test). For all 38 participants, both programs greatly increased maximum walking distance in the graded treadmill test: median 415 [240-650] to 995m [410-1490], with a large effect size (p<10 -4 ).
CONCLUSION


A 4-week intensive rehabilitation program with ITAR or CT for intermittent claudication showed high adherence, was well tolerated, and improved walking distance as much as that reported for longer conventional programs. These findings prompt the design of a larger multicenter randomised controlled trial.
TRIAL REGISTRATION


NCT01734603.",2020,"For all 38 participants, both programs greatly increased maximum walking distance in the graded treadmill test:",['A total of 38 in- or out-patients'],"['ITAR or conventional training with constant slope and speed interspersed with rest periods (CT', 'intensive treadmill training', 'ITAR or CT program', 'ITAR or CT', 'continuous training programs', 'Supervised exercise training']","['tolerated, and improved walking distance', 'walking distance', 'walking distances (constant speed and gradient treadmill test', 'VO 2peak', 'maximum walking distance', 'Tolerance']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0087110', 'cui_str': 'Treadmill Test'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",,0.0964511,"For all 38 participants, both programs greatly increased maximum walking distance in the graded treadmill test:","[{'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Villemur', 'Affiliation': 'Department of Vascular Rehabilitation, Grenoble Alpes University Hospital, 38433 Grenoble, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Thoreau', 'Affiliation': 'Department of Vascular Rehabilitation, Grenoble Alpes University Hospital, 38433 Grenoble, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Guinot', 'Affiliation': 'Sports Medicine Department, Grenoble Alpes University Hospital, 38433 Grenoble, France; INSERM U1042, Laboratory HP2, Grenoble Alpes University Hospital, 38000 Grenoble, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Gailledrat', 'Affiliation': 'Sports Medicine Department, Grenoble Alpes University Hospital, 38433 Grenoble, France; Department of Physical and Rehabilitation Medicine, Grenoble Alpes University Hospital, 38433 Grenoble, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Evra', 'Affiliation': 'Department of Vascular Rehabilitation, Grenoble Alpes University Hospital, 38433 Grenoble, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Vermorel', 'Affiliation': 'INSERM CIC-1406 Grenoble Alpes University Hospital, 38043 Grenoble, France.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Foote', 'Affiliation': 'Research Division, Grenoble Alpes University Hospital, 38433 Grenoble, France. Electronic address: AFoote@chu-grenoble.fr.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Carpentier', 'Affiliation': 'Vascular Medicine Department, Grenoble Alpes University Hospital, 38433 Grenoble, France; Faculty of Medicine, University Grenoble Alpes, 38000 Grenoble, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Bosson', 'Affiliation': 'TIMC-IMAG, University Grenoble Alpes, 38000 Grenoble, France.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Pérennou', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Grenoble Alpes University Hospital, 38433 Grenoble, France; Lab. Cognitive Neurosciences, CNRS UMR5105, Université Grenoble Alpes, 38040 Grenoble, France.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.03.004']
476,31654497,Standard cross-linking protocol versus accelerated and transepithelial cross-linking protocols for treatment of paediatric keratoconus: a 2-year comparative study.,"PURPOSE


To compare the efficacy, safety and stability of standard epithelium-off cross-linking (SCXL) versus accelerated epithelium-off cross-linking (ACXL) and transepithelial epithelium-on cross-linking (TCXL) in the treatment of progressive keratoconus (KC) in children.
METHODS


This prospective multicentre controlled trial included 271 eyes (136 children) with grade 1-3 progressive KC who were randomized to undergo SCXL (n = 91, as a control group), ACXL (n = 92) or TCXL (n = 88). Uncorrected and corrected distance visual acuity, subjective refraction, pachymetry, keratometry and corneal topography measurements were recorded preoperatively and 6, 12 and 24 months postoperatively.
RESULTS


At 1 year, there was no significant difference in uncorrected distance visual acuity, refractive sphere, cylinder, spherical equivalent or Kmax between the ACXL and SCXL groups; however, during year 2, ACXL regressed while SCXL continued to improve. After 2 years, there were significant differences in all visual, refractive and keratometric components between SCXL and both ACXL and TCXL (p < 0.0001) and between ACXL and TCXL (p < 0.0001). KC progressed in 5.4% of patients who had ACXL and 28.4% of those who had TCXL but in none of those who had SCXL. Vernal keratoconjunctivitis was documented in 43.3% of eyes that progressed postoperatively.
CONCLUSION


SCXL was more effective for paediatric KC and achieved greater stability than either ACXL or TCXL, and ACXL was superior to TCXL. SCXL also achieved marked improvement in both myopia and spherical equivalent; however, these refractive outcomes were unpredictable and uncontrollable. TCXL had a 28.4% failure rate within 2 years. SCXL is preferable for management of paediatric KC.",2020,"At 1 year, there was no significant difference in uncorrected distance visual acuity, refractive sphere, cylinder, spherical equivalent or Kmax between the ACXL and SCXL groups; however, during year 2, ACXL regressed while SCXL continued to improve.","['progressive keratoconus (KC) in children', '271 eyes (136 children) with grade 1-3 progressive KC who were randomized to undergo', 'paediatric keratoconus']","['SCXL', 'ACXL', 'TCXL', 'Standard cross-linking protocol versus accelerated and transepithelial cross-linking protocols', 'standard epithelium-off cross-linking (SCXL) versus accelerated epithelium-off cross-linking (ACXL) and transepithelial epithelium-on cross-linking (TCXL', 'ACXL or TCXL']","['Vernal keratoconjunctivitis', 'efficacy, safety and stability', 'KC', 'failure rate', 'uncorrected distance visual acuity, refractive sphere, cylinder, spherical equivalent or Kmax', 'visual, refractive and keratometric components', 'Uncorrected and corrected distance visual acuity, subjective refraction, pachymetry, keratometry and corneal topography measurements']","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0014609', 'cui_str': 'Epithelial Tissue'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}]","[{'cui': 'C0022577', 'cui_str': 'Keratoconjunctivitis, Vernal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C4319645', 'cui_str': 'Cylinder (unit of presentation)'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C1301318', 'cui_str': 'M-Manifest refraction'}, {'cui': 'C0430885', 'cui_str': 'Keratometry (procedure)'}, {'cui': 'C0524957', 'cui_str': 'Corneal Topography'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",271.0,0.102467,"At 1 year, there was no significant difference in uncorrected distance visual acuity, refractive sphere, cylinder, spherical equivalent or Kmax between the ACXL and SCXL groups; however, during year 2, ACXL regressed while SCXL continued to improve.","[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Iqbal', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Sohag University, Sohag, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elmassry', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Hisham', 'Initials': 'H', 'LastName': 'Saad', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Am Gad', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Hamed', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Saeed', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'S Khalil', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Tawfik', 'Affiliation': 'Department of Ophthalmology, Memorial Institute of Ophthalmology, Giza, Egypt.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Said', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Amer', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Alazhar University, Assuit, Egypt.'}, {'ForeName': 'Asaad', 'Initials': 'A', 'LastName': 'Nooreldin', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Alazhar University, Assuit, Egypt.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Said', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Fayoum University, Fayoum, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Reffat', 'Affiliation': 'Department of Ophthalmology, Mansoura Ophthalmic Hospital, Mansoura, Egypt.'}, {'ForeName': 'Seif', 'Initials': 'S', 'LastName': 'Anwar', 'Affiliation': 'Department of Ophthalmology, Mansoura Ophthalmic Hospital, Mansoura, Egypt.'}, {'ForeName': 'Amani', 'Initials': 'A', 'LastName': 'Badawi', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}]",Acta ophthalmologica,['10.1111/aos.14275']
477,32196506,"Efficacy of single versus four repeated doses of praziquantel against Schistosoma mansoni infection in school-aged children from Côte d'Ivoire based on Kato-Katz and POC-CCA: An open-label, randomised controlled trial (RePST).","BACKGROUND


Preventive chemotherapy with praziquantel (PZQ) is the cornerstone of schistosomiasis control. However, a single dose of PZQ (40 mg/kg) does not cure all infections. Repeated doses of PZQ at short intervals might increase efficacy in terms of cure rate (CR) and intensity reduction rate (IRR). Here, we determined the efficacy of a single versus four repeated treatments with PZQ on Schistosoma mansoni infection in school-aged children from Côte d'Ivoire, using two different diagnostic tests.
METHODS


An open-label, randomized controlled trial was conducted from October 2018 to January 2019. School-aged children with a confirmed S. mansoni infection based on Kato-Katz (KK) and point-of-care circulating cathodic antigen (POC-CCA) urine cassette test were randomly assigned to receive either a single or four repeated doses of PZQ, administered at two-week intervals. The primary outcome was the difference in CR between the two treatment arms, measured by triplicate KK thick smears 10 weeks after the first treatment. Secondary outcomes included CR estimated by POC-CCA, IRR by KK and POC-CCA, and safety of repeated PZQ administration.
PRINCIPAL FINDINGS


During baseline screening, 1,022 children were assessed for eligibility of whom 153 (15%) had a detectable S. mansoni infection, and hence, were randomized to the standard treatment group (N = 70) and the intense treatment group (N = 83). Based on KK, the CR was 42% (95% confidence interval (CI) 31-52%) in the standard treatment group and 86% (95% CI 75-92%) in the intense treatment group. Observed IRR was 72% (95% CI 55-83%) in the standard treatment group and 95% (95% CI 85-98%) in the intense treatment group. The CR estimated by POC-CCA was 18% (95% CI 11-27%) and 36% (95% CI 26-46%) in the standard and intense treatment group, respectively. Repeated PZQ treatment did not result in a higher number of adverse events.
CONCLUSION/SIGNIFICANCE


The observed CR using KK was significantly higher after four repeated treatments compared to a single treatment, without an increase in adverse events. Using POC-CCA, the observed CR was significantly lower than measured by KK, indicating that PZQ may be considerably less efficacious as concluded by KK. Our findings highlight the need for reliable and more accurate diagnostic tools, which are essential for monitoring treatment efficacy, identifying changes in transmission, and accurately quantifying the intensity of infection in distinct populations. In addition, the higher CR in the intense treatment group suggests that more focused and intense PZQ treatment can help to advance schistosomiasis control.
TRIAL REGISTRATION


www.clinicaltrials.gov NCT02868385.",2020,"The observed CR using KK was significantly higher after four repeated treatments compared to a single treatment, without an increase in adverse events.","[""school-aged children from Côte d'Ivoire based on Kato-Katz and POC-CCA"", 'During baseline screening, 1,022 children were assessed for eligibility of whom 153 (15%) had a detectable S. mansoni infection, and hence', 'School-aged children with a confirmed S. mansoni infection based on Kato-Katz (KK) and point-of-care circulating cathodic antigen (POC-CCA) urine cassette test', ""school-aged children from Côte d'Ivoire, using two different diagnostic tests"", 'October 2018 to January 2019']","['PZQ', 'praziquantel against Schistosoma mansoni infection', 'praziquantel (PZQ']","['cure rate (CR) and intensity reduction rate (IRR', 'adverse events', 'Schistosoma mansoni infection', 'Observed IRR', 'CR estimated by POC-CCA', 'CR estimated by POC-CCA, IRR by KK and POC-CCA, and safety of repeated PZQ administration', 'observed CR using KK', 'CR']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0042037'}, {'cui': 'C0450240', 'cui_str': 'Cassette (physical object)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0086143'}]","[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C0036330', 'cui_str': 'Schistosoma mansoni Infection'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0083017', 'cui_str': 'IRR'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036330', 'cui_str': 'Schistosoma mansoni Infection'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]",1022.0,0.211,"The observed CR using KK was significantly higher after four repeated treatments compared to a single treatment, without an increase in adverse events.","[{'ForeName': 'Pytsje T', 'Initials': 'PT', 'LastName': 'Hoekstra', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Casacuberta-Partal', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Lisette', 'Initials': 'L', 'LastName': 'van Lieshout', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Paul L A M', 'Initials': 'PLAM', 'LastName': 'Corstjens', 'Affiliation': 'Department of Cell and Chemical Biology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Roula', 'Initials': 'R', 'LastName': 'Tsonaka', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Rufin K', 'Initials': 'RK', 'LastName': 'Assaré', 'Affiliation': ""Centre Suisse de Recherches Scientifiques en Côte d'Ivoire, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Kigbafori D', 'Initials': 'KD', 'LastName': 'Silué', 'Affiliation': ""Centre Suisse de Recherches Scientifiques en Côte d'Ivoire, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Aboulaye', 'Initials': 'A', 'LastName': 'Meité', 'Affiliation': ""Programme National de Lutte contre les Maladies Tropicales Négligées à Chimiothérapie Préventive, Ministère de la Santé et de l'Hygiène Publique, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Eliézer K', 'Initials': 'EK', 'LastName': ""N'Goran"", 'Affiliation': ""Centre Suisse de Recherches Scientifiques en Côte d'Ivoire, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Yves K', 'Initials': 'YK', 'LastName': ""N'Gbesso"", 'Affiliation': ""Département d'Agboville, Centre de Santé Urbain d'Azaguié, Azaguié, Côte d'Ivoire.""}, {'ForeName': 'Abena S', 'Initials': 'AS', 'LastName': 'Amoah', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Meta', 'Initials': 'M', 'LastName': 'Roestenberg', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Knopp', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Utzinger', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Jean T', 'Initials': 'JT', 'LastName': 'Coulibaly', 'Affiliation': ""Centre Suisse de Recherches Scientifiques en Côte d'Ivoire, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Govert J', 'Initials': 'GJ', 'LastName': 'van Dam', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008189']
478,31640613,"The ReThink study: a 3-arm parallel randomized trial of cognitive bias modification, with and without adherence promotion, for adolescent anxiety disorder: trial design and protocol.","BACKGROUND


Anxiety disorders are the most common mental health problem among youth, contribute to reduced quality of daily life, and are associated with high rates of comorbidity. However, treatment rates for anxiety are very low, causing a sizeable treatment gap. There is an immediate need to identify treatment interventions that are effective, affordable, and can be delivered easily to the youth population. Cognitive Bias Modification (CBM) is one potentially effective intervention that could reach youth on a large scale, especially when self-administered at home. Thus, we aim to assess the benefit of CBM to treat youth anxiety. Further, we aim to test whether adding an adherence promotion (AP) component to the CBM intervention can improve outcomes, and whether CBM delivered both with and without the AP component is cost effective.
METHODS


This is a 12-month randomized controlled trial (RCT) conducted within an existing healthcare system. Potentially eligible youth (ages 12 to 17) will be identified by reviewing the electronic health record (EHR) for clinical anxiety diagnoses, which are then confirmed via research interview. We aim to enroll 498 participants and randomize them 1:1:1 to one of three arms: Arm 1 is a Low-Ratio version of the CBM program (nearly identical to the other CBM versions, but minimally effective); Arm 2 is a High-Ratio ""active"" CBM program; and Arm 3 is the High-Ratio CBM program with an added AP component. Participants will complete assessments at baseline, 1-, 3-, 6- and 12-months post-baseline. Youth in all three arms will self-administer the CBM program at home and will be asked to complete twelve intervention sessions over a four-week period. Arm 3 participants (High-Ratio CBM + AP) will also receive up to four telephone calls from phone coaches during the intervention period to provide technical assistance, encouragement, and motivational enhancement to increase adherence. The primary clinical outcome will be anxiety remission at 6-month follow-up.
DISCUSSION


This study protocol describes the method and design for an RCT to test whether self-administered CBM both with and without adherence promotion can be an effective at-home treatment for anxious youth.
TRIAL REGISTRATION


ClinicalTrials.gov : NCT02156531, First Posted June 5, 2014.",2019,"There is an immediate need to identify treatment interventions that are effective, affordable, and can be delivered easily to the youth population.","['Potentially eligible youth (ages 12 to 17', 'adolescent anxiety disorder', 'anxious youth', 'enroll 498 participants']","['CBM', 'Low-Ratio version of the CBM program (nearly identical to the other CBM versions, but minimally effective); Arm 2 is a High-Ratio ""active"" CBM program; and Arm 3 is the High-Ratio CBM program with an added AP component', 'Cognitive Bias Modification (CBM', 'CBM intervention', 'cognitive bias modification, with and without adherence promotion']",['anxiety remission at 6-month follow-up'],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",498.0,0.0666178,"There is an immediate need to identify treatment interventions that are effective, affordable, and can be delivered easily to the youth population.","[{'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Reetz', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800 North Interstate Avenue, Portland, OR, 97227, USA. shelleydurant24@gmail.com.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Clarke', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800 North Interstate Avenue, Portland, OR, 97227, USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Weersing', 'Affiliation': 'San Diego State University (SDSU), 5500 Campanile Drive, San Diego, CA, 92182, USA.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Amir', 'Affiliation': 'San Diego State University (SDSU), 5500 Campanile Drive, San Diego, CA, 92182, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Dickerson', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800 North Interstate Avenue, Portland, OR, 97227, USA.'}, {'ForeName': 'Frances L', 'Initials': 'FL', 'LastName': 'Lynch', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800 North Interstate Avenue, Portland, OR, 97227, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Leo', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800 North Interstate Avenue, Portland, OR, 97227, USA.'}, {'ForeName': 'Andreea M', 'Initials': 'AM', 'LastName': 'Rawlings', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800 North Interstate Avenue, Portland, OR, 97227, USA.'}, {'ForeName': 'Mi H', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800 North Interstate Avenue, Portland, OR, 97227, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Gille', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800 North Interstate Avenue, Portland, OR, 97227, USA.'}]",BMC psychiatry,['10.1186/s12888-019-2296-z']
479,31640632,Persistent physical symptoms reduction intervention: a system change and evaluation in secondary care (PRINCE secondary) - a CBT-based transdiagnostic approach: study protocol for a randomised controlled trial.,"BACKGROUND


Persistent physical symptoms (PPS), also known as medically unexplained symptoms (MUS), affect approximately 50% of patients in secondary care and are often associated with disability, psychological distress and increased health care costs. Cognitive behavioural therapy (CBT) has demonstrated both short- and long-term efficacy with small to medium effect sizes for PPS, with larger treatment effects for specific PPS syndromes, including non-cardiac chest pain, irritable bowel syndrome (IBS) and chronic fatigue syndrome (CFS). Research indicates that PPS conditions share similar cognitive and behavioural responses to symptoms, such as avoidance and unhelpful beliefs. This suggests that a transdiagnostic approach may be beneficial for patients with PPS.
METHODS


A randomised controlled trial (RCT) will be conducted to evaluate the efficacy and cost-effectiveness of a transdiagnostic CBT-based intervention for PPS. 322 participants with PPS will be recruited from secondary care clinics. Participants stratified by clinic and disability level will be randomised to CBT plus standard medical care (SMC) versus SMC alone. The intervention consists of 8 CBT sessions delivered by a qualified therapist over a period of 20 weeks. Outcomes will be assessed at 9, 20, 40- and 52-weeks post randomisation. Efficacy will be assessed by examining the difference between arms in the primary outcome Work and Social Adjustment Scale (WSAS) at 52 weeks after randomisation. Secondary outcomes will include mood, symptom severity and clinical global impression at 9, 20, 40 and 52 weeks. Cost-effectiveness will be evaluated by combining measures of health service use, informal care, loss of working hours and financial benefits at 52 weeks.
DISCUSSION


This trial will provide a powered evaluation of the efficacy and cost-effectiveness of a transdiagnostic CBT approach versus SMC for patients with PPS. It will also provide valuable information about potential healthcare pathways for patients with PPS within the National Health Service (NHS).
TRIAL REGISTRATION


ClinicalTrials.gov NCT02426788. Registered 27 April 2015. Overall trial status: Ongoing; Recruitment status: No longer recruiting.",2019,Efficacy will be assessed by examining the difference between arms in the primary outcome Work and Social Adjustment Scale (WSAS) at 52 weeks after randomisation.,"['patients with PPS', 'Participants stratified by clinic and disability level', '322 participants with PPS will be recruited from secondary care clinics', 'patients with PPS within the National Health Service (NHS']","['transdiagnostic CBT approach versus SMC', 'CBT plus standard medical care (SMC) versus SMC alone', 'Cognitive behavioural therapy (CBT', 'transdiagnostic CBT-based intervention']","['Social Adjustment Scale (WSAS', 'Cost-effectiveness', 'Efficacy', 'mood, symptom severity and clinical global impression', 'efficacy and cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4517712', 'cui_str': 'Three hundred and twenty-two'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0451485', 'cui_str': 'Social adjustment scale (assessment scale)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",322.0,0.226477,Efficacy will be assessed by examining the difference between arms in the primary outcome Work and Social Adjustment Scale (WSAS) at 52 weeks after randomisation.,"[{'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK. trudie.chalder@kcl.ac.uk.""}, {'ForeName': 'Meenal', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'James', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hotopf', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Frank', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Watts', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""Health Economics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'David', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ashworth', 'Affiliation': ""Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Mujtaba', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Garrood', 'Affiliation': ""Department of Rheumatology, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Moss-Morris', 'Affiliation': ""School of Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Landau', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",BMC psychiatry,['10.1186/s12888-019-2297-y']
480,31606036,Reducing inappropriate psychotropic drug use in nursing home residents with dementia: protocol for participatory action research in a stepped-wedge cluster randomized trial.,"BACKGROUND


Psychotropic drugs are often prescribed to treat neuropsychiatric symptoms in nursing home residents with dementia, despite having limited efficacy and considerable side effects. To reduce the inappropriate prescribing of these psychotropic drugs, various non-pharmacological, psychosocial, person-centered, or multidisciplinary interventions are advocated. However, existing multidisciplinary interventions have shown variable effects, with limited effectiveness often resulting from suboptimal implementation. We hypothesize that an effective intervention needs to fit the local situation of a nursing home and that support should be offered during implementation.
METHODS


We will embed participatory action research within a stepped-wedge cluster randomized controlled trial to study the effects of a tailored intervention and implementation plan to reduce inappropriate psychotropic drug prescribing. Nursing homes will be provided with tailored information about the perceived problems of managing neuropsychiatric symptoms and we will offer coaching support throughout. Alongside the participatory action research, we will perform a process evaluation to examine the quality of the study, the intervention, and the implementation. Our aim is to recruit 600 residents from 16 nursing homes throughout the Netherlands, with measurements taken at baseline, 8 months, and 16 months. Nursing homes will be randomly allocated to an intervention or a deferred intervention group. During each intervention stage, we will provide information about inappropriate psychotropic drug prescribing, neuropsychiatric symptoms, and difficulties in managing neuropsychiatric symptoms through collaboration with each nursing home. After this, a tailored intervention and implementation plan will be written and implemented, guided by a coach. The primary outcome will be the reduction of inappropriate prescribing, as measured by the Appropriate Psychotropic drug use In Dementia index. Secondary outcomes will be the frequency of psychotropic drug use and neuropsychiatric symptoms, plus quality of life. A mixed methods design will be used for the process evaluation. Effects will be assessed using multilevel analyses. The project leader of the nursing home and the coach will complete questionnaires and in-depth interviews.
DISCUSSION


We anticipate that the proposed tailored intervention with coaching will reduce inappropriate psychotropic drug prescribing for nursing home residents with neuropsychiatric symptoms. This study should also provide insights into the barriers to, and facilitators of, implementation.
TRIAL REGISTRATION


NTR5872 , registered on July 2, 2016.",2019,"The primary outcome will be the reduction of inappropriate prescribing, as measured by the Appropriate Psychotropic drug use","['600 residents from 16 nursing homes throughout the Netherlands, with measurements taken at baseline, 8\u2009months, and 16\u2009months', 'nursing home residents with neuropsychiatric symptoms', 'nursing home residents with dementia', 'Nursing homes']",[],"['reduction of inappropriate prescribing, as measured by the Appropriate Psychotropic drug use', 'frequency of psychotropic drug use and neuropsychiatric symptoms, plus quality of life']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C4285807', 'cui_str': 'Neuropsychiatric symptoms'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}]",[],"[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2936303', 'cui_str': 'Inappropriate Prescribings'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0033978', 'cui_str': 'Psychoactive Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4285807', 'cui_str': 'Neuropsychiatric symptoms'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0034380'}]",600.0,0.153989,"The primary outcome will be the reduction of inappropriate prescribing, as measured by the Appropriate Psychotropic drug use","[{'ForeName': 'Claudia M', 'Initials': 'CM', 'LastName': 'Groot Kormelinck', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, HPC FA21, PO Box 253, 9700 AD, Groningen, The Netherlands. c.m.groot.kormelinck@umcg.nl.'}, {'ForeName': 'Charlotte F', 'Initials': 'CF', 'LastName': 'van Teunenbroek', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, HPC FA21, PO Box 253, 9700 AD, Groningen, The Netherlands.'}, {'ForeName': 'Boudewijn J', 'Initials': 'BJ', 'LastName': 'Kollen', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, HPC FA21, PO Box 253, 9700 AD, Groningen, The Netherlands.'}, {'ForeName': 'Margreet', 'Initials': 'M', 'LastName': 'Reitsma', 'Affiliation': 'Vilans, (Center of Expertise for Long-term Care), PO Box 8228, 3503 RE, Utrecht, The Netherlands.'}, {'ForeName': 'Debby L', 'Initials': 'DL', 'LastName': 'Gerritsen', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Radboud Institute for Health Sciences, Radboudumc Alzheimer Center, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Smalbrugge', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, Amsterdam UMC, location VUmc/Amsterdam Public Health Research Institute, PO Box 7057, 1007 MB, Amsterdam, The Netherlands.'}, {'ForeName': 'Sytse U', 'Initials': 'SU', 'LastName': 'Zuidema', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, HPC FA21, PO Box 253, 9700 AD, Groningen, The Netherlands.'}]",BMC psychiatry,['10.1186/s12888-019-2291-4']
481,31619196,Effectiveness of a brief psychological mindfulness-based intervention for the treatment of depression in primary care: study protocol for a randomized controlled clinical trial.,"BACKGROUND


Depressive symptoms are quite prevalent in Primary Care (PC) settings. The treatment as usual (TAU) in PC is pharmacotherapy, despite the high relapse rates it produces. Many patients would prefer psychotherapy, but specialized services are overloaded. Studies that apply Mindfulness-Based Interventions (MBIs) for the treatment of depression have obtained significant improvements. Brief low-intensity approaches delivered from PC could be a promising approach. This study aims to compare a low-intensity mindfulness intervention for the treatment of depression in PC using different intervention formats - a face-to-face MBI delivered in a group and the same MBI individually applied on the Internet - to a control group that will receive PC medical treatment as usual.
METHODS


A randomized controlled clinical trial will be conducted in PC, with about 120 depressed patients allocated (1:1:1) to three groups: ""face-to-face MBI + TAU"", ""Internet-delivered MBI + TAU"", and ""TAU alone"". The MBI programs will be composed of four modules. The primary outcome will be depressive symptoms, measured through the Beck Depression Inventory, assessed at pre- and post-treatment and 6- and 12-month follow-ups. Other outcomes will be mindfulness, happiness, affectivity, quality of life, and the use of healthcare services. Intention-to-treat analysis using linear mixed models adjusted for baseline scores and routine sociodemographic analysis that could show baseline differences will be conducted. Per-protocol secondary outcome analyses will also be performed.
DISCUSSION


This is the first Spanish RCT to apply a low-intensity face-to-face MBI (plus TAU) to treat depression in PC settings compared to TAU (alone). Moreover, this study will also make it possible to evaluate the same MBI program (plus TAU), but Internet-delivered, considering their cost-effectiveness. Positive results from this RCT might have an important impact on mental health settings, helping to decrease the overload of the system and offering treatment alternatives beyond antidepressant medication through high-quality, flexible PC interventions.
TRIAL REGISTRATION


Clinical Trials.gov NCT03034343 . Trial Registration date 24 January 2017, retrospectively registered.",2019,"This study aims to compare a low-intensity mindfulness intervention for the treatment of depression in PC using different intervention formats - a face-to-face MBI delivered in a group and the same MBI individually applied on the Internet - to a control group that will receive PC medical treatment as usual.
","['120 depressed patients allocated (1:1:1) to three groups', '24 January 2017, retrospectively registered']","['psychological mindfulness-based intervention', 'low-intensity mindfulness intervention', 'face-to-face MBI\u2009+\u2009TAU"", ""Internet-delivered MBI\u2009+\u2009TAU"", and ""TAU alone']","['mindfulness, happiness, affectivity, quality of life, and the use of healthcare services', 'depressive symptoms, measured through the Beck Depression Inventory']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0034380'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0557829', 'cui_str': 'Healthcare services (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}]",120.0,0.171018,"This study aims to compare a low-intensity mindfulness intervention for the treatment of depression in PC using different intervention formats - a face-to-face MBI delivered in a group and the same MBI individually applied on the Internet - to a control group that will receive PC medical treatment as usual.
","[{'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Lopez-Montoyo', 'Affiliation': 'Universitat Jaume I, Av. Vicente Sos Baynat s/n, 12006, Castellón, Spain.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Quero', 'Affiliation': 'Universitat Jaume I, Av. Vicente Sos Baynat s/n, 12006, Castellón, Spain. squero@uji.es.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Montero-Marin', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (RedIAPP), Zaragoza, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Barcelo-Soler', 'Affiliation': 'University of Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Beltran', 'Affiliation': 'University of Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Campos', 'Affiliation': 'Universitat Jaume I, Av. Vicente Sos Baynat s/n, 12006, Castellón, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Garcia-Campayo', 'Affiliation': 'Department of Psychiatry, University of Zaragoza, Zaragoza, Spain.'}]",BMC psychiatry,['10.1186/s12888-019-2298-x']
482,32259016,Diabetes and Clinical Outcome in Patients With Metastatic Colorectal Cancer: CALGB 80405 (Alliance).,"Background


Diabetes is a prognostic factor for some malignancies, but its association with outcome in patients with advanced or metastatic colorectal cancer (CRC) is less clear.
Methods


This cohort study was nested within a randomized trial of first-line chemotherapy and bevacizumab and/or cetuximab for advanced or metastatic CRC. Patients were enrolled at 508 community and academic centers throughout the National Clinical Trials Network. The primary exposure was physician-documented diabetes at the time of enrollment. The primary endpoint was overall survival (OS); secondary endpoints were progression-free survival (PFS) and adverse events. Tests of statistical significance were two-sided.
Results


Among 2326 patients, 378 (16.3%) had diabetes. The median follow-up time was 6.0 years. We observed 1973 OS events and 2173 PFS events. The median time to an OS event was 22.7 months among those with diabetes and 27.1 months among those without diabetes (HR = 1.27, 95% CI = 1.13 to 1.44;  P  <   .001). The median time to a PFS event was 9.7 months among those with diabetes and 10.8 months among those without diabetes (HR = 1.16, 95% CI = 1.03 to 1.30;  P  =   .02). Patients with diabetes were more likely to experience no less than grade 3 hypertension (8.1% vs 4.4%;  P  =   .054) but were not more likely to experience other adverse events, including neuropathy.
Conclusions


Diabetes is associated with an increased risk of mortality and tumor progression in patients with advanced or metastatic CRC. Patients with diabetes tolerate first-line treatment with chemotherapy and monoclonal antibodies similarly to patients without diabetes.",2020,"Patients with diabetes were more likely to experience no less than grade 3 hypertension (8.1% vs 4.4%;  P  =   .054) but were not more likely to experience other adverse events, including neuropathy.
","['Patients were enrolled at 508 community and academic centers throughout the National Clinical Trials Network', 'Patients with diabetes tolerate first-line treatment with', 'patients with advanced or metastatic colorectal cancer (CRC', 'advanced or metastatic CRC', 'Patients', '2326 patients, 378 (16.3%) had diabetes', 'patients with advanced or metastatic CRC']","['bevacizumab and/or cetuximab', 'chemotherapy and monoclonal antibodies']","['physician-documented diabetes', 'overall survival (OS); secondary endpoints were progression-free survival (PFS) and adverse events', 'median time to a PFS event', 'median time to an OS event', 'grade 3 hypertension', 'adverse events, including neuropathy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}]",2326.0,0.0321453,"Patients with diabetes were more likely to experience no less than grade 3 hypertension (8.1% vs 4.4%;  P  =   .054) but were not more likely to experience other adverse events, including neuropathy.
","[{'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Brown', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Sui', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Venook', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Innocenti', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Bert H', 'Initials': 'BH', 'LastName': ""O'Neil"", 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Shaw', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Blase N', 'Initials': 'BN', 'LastName': 'Polite', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Crystal S', 'Initials': 'CS', 'LastName': 'Denlinger', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Atkins', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mayer', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Blanke', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}]",JNCI cancer spectrum,['10.1093/jncics/pkz078']
483,32257035,3D Printed Patient-Specific Acetabular Jig for Cup Placement in Total Hip Arthroplasty.,"Introduction


Acetabular cup placement is an important modifiable factor determining complication rates like aseptic loosening and hip dislocation related to faulty cup placement, which by standard method is largely dependent upon eyeballing and surgeon's judgment. We evaluated a self-designed, low-cost, patient-specific acetabular jig to guide cup placement in total hip arthroplasty in comparison to conventional technique.
Methods


It was a prospective randomized control study. Thirty-six patients were categorized into group-A & group-B. In group-A, virtually designed acetabular jig was 3 Dimensional (3D) printed and used intra-operatively to guide cup placement. In group-B, the standard method of cup placement was used. Acetabular cup placement was evaluated on post-operative x-rays and compared between two groups.
Results


In group-A, angle of anteversion were significantly in centre of range of safe zone as compared to group B in which hip is maximally stable with more precision in creating hip centre as compared to group-B without any significant( p  = 0.325) increase in surgical time or blood loss.
Conclusion


Computed tomography (CT) scan based virtual pre-operative templating and cup placement guided by virtually designed, patient-specific acetabular jig is a low-cost tool with a short learning curve which can be designed and made available easily. It is a useful tool in decreasing chances of malpositioning of cup and recreates hip centre close to anatomical one especially in cases where anatomy has been distorted such as bony ankylosis and developmental dysplasia of hip.",2020,"In group-A, angle of anteversion were significantly in centre of range of safe zone as compared to group B in which hip is maximally stable with more precision in creating hip centre as compared to group-B without any significant( p  = 0.325) increase in surgical time or blood loss.
",['Total Hip Arthroplasty'],"['Conclusion\n\n\nComputed tomography (CT) scan based virtual\xa0pre-operative\xa0templating and cup placement guided', 'self-designed,\xa0low-cost,\xa0patient-specific acetabular jig to guide cup placement', '3D Printed Patient-Specific Acetabular Jig for Cup Placement']","['surgical time or blood loss', 'Acetabular cup placement']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0033161', 'cui_str': 'Printing'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",,0.0201704,"In group-A, angle of anteversion were significantly in centre of range of safe zone as compared to group B in which hip is maximally stable with more precision in creating hip centre as compared to group-B without any significant( p  = 0.325) increase in surgical time or blood loss.
","[{'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Mishra', 'Affiliation': '1Maulana Azad Medical College and Lok Nayak Hospital, New Delhi, India.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Verma', 'Affiliation': '1Maulana Azad Medical College and Lok Nayak Hospital, New Delhi, India.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Rajkumar', 'Affiliation': '1Maulana Azad Medical College and Lok Nayak Hospital, New Delhi, India.'}, {'ForeName': 'Gaurang', 'Initials': 'G', 'LastName': 'Agarwal', 'Affiliation': '1Maulana Azad Medical College and Lok Nayak Hospital, New Delhi, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': '2Lady Hardinge Medical College, New Delhi, India.'}, {'ForeName': 'Lalit', 'Initials': 'L', 'LastName': 'Maini', 'Affiliation': '1Maulana Azad Medical College and Lok Nayak Hospital, New Delhi, India.'}]",Indian journal of orthopaedics,['10.1007/s43465-020-00061-2']
484,32278858,A dose-response evaluation of purified anthocyanins on inflammatory and oxidative biomarkers and metabolic risk factors in healthy young adults: A randomized controlled trial.,"OBJECTIVES


Anthocyanins derived from different plant sources have been found to possess a variety of health-promoting effects, including antiinflammatory properties and protection from oxidative stress. The aim of this study was to investigate the dose-response relationship between anthocyanins and metabolic risk factors as well as inflammatory and oxidative biomarkers in healthy adult volunteers.
METHODS


We conducted a randomized, double-blind, placebo-controlled trial, which included an increasing dosing schedule of 20, 40, 80, 160, and 320 mg of purified anthocyanins or placebo. Participants (n = 111) were administered either agent for 14 consecutive days.
RESULTS


No significant differences in either baseline characteristics or daily intake of dietary nutrients were detected between the experimental and control groups. After anthocyanin supplementation, there was a significant difference in adjusted fasting plasma glucose levels. The group receiving 80 mg/d of anthocyanin had the lowest baseline-adjusted fasting plasma glucose when compared with placebo (F = 3.556, P = 0.007). Logarithmically adjusted plasma interleukin-10 levels were negatively correlated with increasing anthocyanin dose (F = 2.738, P = 0.025). Similarly, 8-iso-prostaglandin F2α levels decreased with increasing anthocyanins dose (F = 3.513, P = 0.009).
CONCLUSIONS


Taken together, our results suggest that anthocyanin supplementation at a dose greater than 80 mg/d is an effective antioxidant and antiinflammatory agent in healthy young adults.",2020,"The group receiving 80 mg/d of anthocyanin had the lowest baseline-adjusted fasting plasma glucose when compared with placebo (F = 3.556, P = 0.007).","['healthy adult volunteers', 'healthy young adults']","['purified anthocyanins or placebo', 'anthocyanin', 'placebo', 'purified anthocyanins', 'anthocyanin supplementation']","['baseline characteristics or daily intake of dietary nutrients', '8-iso-prostaglandin F2α levels', 'inflammatory and oxidative biomarkers and metabolic risk factors', 'adjusted fasting plasma glucose levels', 'fasting plasma glucose', 'Logarithmically adjusted plasma interleukin-10 levels']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",111.0,0.500311,"The group receiving 80 mg/d of anthocyanin had the lowest baseline-adjusted fasting plasma glucose when compared with placebo (F = 3.556, P = 0.007).","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Nutrition, School of Public Health, Guangdong Medical University, Dongguan, China; Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Peiwen', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Nutrition, School of Public Health, Guangdong Medical University, Dongguan, China.'}, {'ForeName': 'Yongji', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Nutrition, Henry Fok School of Food Science and Engineering, Shaoguan University, Shaoguan, China.'}, {'ForeName': 'Longying', 'Initials': 'L', 'LastName': 'Zha', 'Affiliation': 'Guangdong Provincial Key Laboratory of Tropical Disease Research, Department of Nutrition and Food Hygiene, School of Public Health, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Ling', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Honghui', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Department of Nutrition, School of Public Health, Guangdong Medical University, Dongguan, China; Department of Nutrition, Henry Fok School of Food Science and Engineering, Shaoguan University, Shaoguan, China. Electronic address: guohh1999@hotmail.com.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110745']
485,32200266,Efficacy and safety of immediate oral intake in patients with mild acute pancreatitis: A randomized controlled trial.,"OBJECTIVES


Early enteral nutrition is recommended for patients with severe acute pancreatitis (AP); however, nutritional management strategies for patients with mild AP have not been established. The aim of this study was to evaluate the benefits and safety of immediate oral intake of low-fat solid food in patients with mild AP who were allowed to take opioid analgesics.
METHODS


In this single-center randomized study, the immediate feeding (IMF) group was permitted immediate oral intake of low-fat (15 g/d) solid food. In the standard food (STF) group, patients received gradually increasing amounts of dietary fat. Twenty-six patients were randomized, with 13 allocated to each group. The primary outcome was the period between diagnosis and recovery from AP. The cost and rate of progression to severe disease were evaluated as secondary outcomes.
RESULTS


The IMF group (mean recovery days: 2 ± 1) recovered significantly earlier (mean difference in recovery days: 6.3; 95% confidence interval [CI], 4.8-7.9; P < 0.001) than the STF group (mean recovery days: 8.3 ± 2.3), with a lower overall treatment cost (mean difference in costs: -$460; 95% CI, -$880 to -$40; P = 0.034). The IMF group showed a lower rate of progression to severe AP (IMF, 0%; STF, 15.3%; P = 0.48).
CONCLUSION


The initial treatment strategy for mild AP should be altered from the gradual introduction of oral feeding upon the absence of pain to immediate oral nutrition with opioid analgesics, to improve treatment efficacy and reduce treatment cost.",2020,"The IMF group showed a lower rate of progression to severe AP (IMF, 0%; STF, 15.3%; P = 0.48).
","['patients with mild AP who were allowed to take opioid analgesics', 'Twenty-six patients', 'patients with severe acute pancreatitis (AP', 'patients with mild acute pancreatitis']","['immediate oral intake', 'IMF', 'immediate feeding (IMF', 'standard food (STF']","['period between diagnosis and recovery from AP', 'Efficacy and safety', 'rate of progression to severe AP', 'cost and rate of progression to severe disease']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0002772', 'cui_str': 'Analgesics, Opioid'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis (disorder)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0016452', 'cui_str': 'Food'}]","[{'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",26.0,0.141563,"The IMF group showed a lower rate of progression to severe AP (IMF, 0%; STF, 15.3%; P = 0.48).
","[{'ForeName': 'Masayasu', 'Initials': 'M', 'LastName': 'Horibe', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Iwasaki', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Atsuo', 'Initials': 'A', 'LastName': 'Nakagawa', 'Affiliation': 'Clinical and Translational Research Center, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Juntaro', 'Initials': 'J', 'LastName': 'Matsuzaki', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Minami', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yujiro', 'Initials': 'Y', 'LastName': 'Machida', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Tamagawa', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Takimoto', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Ueda', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Katayama', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Kawasaki', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Misako', 'Initials': 'M', 'LastName': 'Matsushita', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Seino', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Seiichiro', 'Initials': 'S', 'LastName': 'Fukuhara', 'Affiliation': 'Center for Diagnostic and Therapeutic Endoscopy, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Kanai', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan. Electronic address: takagast@z2.keio.jp.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110724']
486,32222582,"Aggressive weight-loss program with a ketogenic induction phase for the treatment of chronic plaque psoriasis: A proof-of-concept, single-arm, open-label clinical trial.","OBJECTIVES


A very low-calorie ketogenic diet (VLCKD) has been associated with a significant reduction in visceral adipose tissue and ketone bodies that likely possess antiinflammatory properties. We evaluated the efficacy of an aggressive weight-loss (WL) program with a ketogenic induction phase as first-line treatment for chronic plaque psoriasis.
METHODS


Adult patients who were overweight or obese and drug-naïve (i.e., never treated, excluding the use of topical emollients; n = 37; 30% men; age: 43.1 ± 13.8 y) with stable chronic plaque psoriasis underwent a 10-wk, 2-phase WL program consisting of a 4-wk protein-sparing, VLCKD (<500 kcal/d; 1.2 g of protein/kg of ideal body weight/d) and 6-wk balanced, hypocaloric (25-30 kcal/kg of ideal body weight/d), Mediterranean-like diet. The primary endpoint was the reduction in Psoriasis Area and Severity Index (PASI) score at wk 10. Major secondary endpoints included PASI score responses of ≥50% and ≥75%, reduction in body surface area involved, improvement in itch severity (visual analogue scale), and Dermatology Life Quality Index score at wk 10.
RESULTS


With a mean body weight reduction of 12.0% (-10.6 kg), the dietary intervention resulted in a significant reduction in PASI (baseline score: 13.8 ± 6.9; range, 7-32), with a mean change of -10.6 (95% confidence interval, -12.8 to -8.4; P < 0.001). PASI score responses of ≥50% and ≥75% were recorded in 36 patients (97.3%) and 24 patients (64.9%), respectively. Treatment also resulted in a significant reduction (P < 0.001) in the body surface area involved (-17.4%) and an improvement in itch severity (-33.2 points) and Dermatology Life Quality Index score (-13.4 points).
CONCLUSIONS


In drug-naïve adult overweight patients with stable chronic plaque psoriasis, an aggressive dietary WL program consisting of a VLCKD, followed by a balanced, hypocaloric, Mediterranean-like diet, appeared to be an effective first-line strategy to reduce disease severity.",2020,"PASI score responses of ≥50% and ≥75% were recorded in 36 patients (97.3%) and 24 patients (64.9%), respectively.","['chronic plaque psoriasis', 'drug-naïve adult overweight patients with stable chronic plaque psoriasis', 'Adult patients who were overweight or obese and drug-naïve (i.e., never treated, excluding the use of topical emollients; n\xa0=\xa037; 30% men; age: 43.1 ± 13.8 y) with stable chronic plaque psoriasis underwent a 10-wk, 2-phase']","['aggressive weight-loss (WL) program', 'Mediterranean-like diet', '4-wk protein-sparing, VLCKD', 'Aggressive weight-loss program with a ketogenic induction phase', 'calorie ketogenic diet (VLCKD']","['itch severity', 'PASI score responses of ≥50% and ≥75%, reduction in body surface area involved, improvement in itch severity (visual analogue scale), and Dermatology Life Quality Index score', 'reduction in Psoriasis Area and Severity Index (PASI) score', 'PASI score responses', 'PASI', 'mean body weight reduction', 'Dermatology Life Quality Index score', 'body surface area']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0013983', 'cui_str': 'Emollients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517561', 'cui_str': '13.8 (qualifier value)'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic Diet'}]","[{'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C4706308', 'cui_str': 'Dermatology Life Quality Index score'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",,0.0345302,"PASI score responses of ≥50% and ≥75% were recorded in 36 patients (97.3%) and 24 patients (64.9%), respectively.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Castaldo', 'Affiliation': 'Nutriketo Lab A.O.R.N. San Giuseppe Moscati, Contrada Amoretta, Avellino, Italy; University of Salerno, Salerno, Italy. Electronic address: lavoronep@yahoo.it.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Rastrelli', 'Affiliation': 'Department of Pharmacy, Faculty of Pharmacy, University of Salerno, Fisciano, Salerno, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Galdo', 'Affiliation': 'Oncologic Dermatology Unit, IRCCS-CROB, Rionero in Vulture, Potenza, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Molettieri', 'Affiliation': 'Nutriketo Lab A.O.R.N. San Giuseppe Moscati, Contrada Amoretta, Avellino, Italy.'}, {'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Rotondi Aufiero', 'Affiliation': 'Dermatology and Dermatosurgery Unit, A.O.R.N. San Giuseppe Moscati, Avellino, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Cereda', 'Affiliation': 'Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110757']
487,32406383,Effectiveness of video game on bio- physiological parameters during intravenous cannulation among preschool children.,"Background Hospitalization is a completely new experience for infants and young children; they are too young to understand the stress of hospitalization. Distractions or diversions seek to divert the child's attention to interesting or challenging tasks to draw attention away from painful or distressful medical procedure. Therefore, the present study assesses the effectiveness of video game on bio-physiological parameters during intravenous cannulation among preschool children admitted in paediatric ward. Methods A randomized true experimental research design was used to assess the effectiveness of video game technique on pain and bio-physiological parameters during Intravenous Cannulation among preschool children admitted in paediatric ward at Sri Ramachandra Hospital in Chennai. The collected data were grouped and analysed using descriptive and inferential statistics, to assess the effectiveness of video games. Results There was a significant difference in the mean score of oxygen saturation of post-test compare to pre-test for both groups. The number of children feeling severe pain was more in the control group during intervention and this difference was highly significant. Oxygen saturation was more in control but not significant, but the heart rate was significantly higher in control group during intervention. There was no association during pre- post-test and oxygen saturation, with selected demographic variables of the preschool children in both groups, apart from the fact that children from low income group had significant low heart rate during pre- and post-test Discussion Video game is an effective method in reducing pain in children undergoing intravenous cannulation. In this framework, the intervention (showing video game) reduced perception of pain and changes in bio-physiological parameters such as, heart rate and oxygen saturation, during intravenous cannulation.",2020,There was a significant difference in the mean score of oxygen saturation of post-test compare to pre-test for both groups.,"['infants and young children', 'preschool children admitted in paediatric ward', 'preschool children admitted in paediatric ward at Sri Ramachandra Hospital in Chennai', 'children undergoing intravenous cannulation', 'preschool children']","['video game technique', 'video game']","['bio- physiological parameters', 'number of children feeling severe pain', 'pain and bio-physiological parameters', 'low heart rate', 'perception of pain and changes in bio-physiological parameters such as, heart rate and oxygen saturation', 'heart rate', 'Oxygen saturation', 'pain', 'mean score of oxygen saturation']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0398266', 'cui_str': 'Catheterization of vein'}]","[{'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0396564,There was a significant difference in the mean score of oxygen saturation of post-test compare to pre-test for both groups.,"[{'ForeName': 'M Jaya', 'Initials': 'MJ', 'LastName': 'Rackini', 'Affiliation': 'Faculty of Nursing, Sri Ramachandra Medical College and Research Institution (DU), Porur, Chennai, Tamil Nadu 600116, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shanmugapriya', 'Affiliation': 'Faculty of Nursing, Sri Ramachandra Medical College and Research Institution (DU), Porur, Chennai, Tamil Nadu 600116, India.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'David', 'Affiliation': 'Faculty of Nursing, Sri Ramachandra Medical College and Research Institution (DU), Porur, Chennai, Tamil Nadu 600116, India.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2019-0056']
488,32234652,Gut microbiota composition after diet and probiotics in overweight breast cancer survivors: a randomized open-label pilot intervention trial.,"OBJECTIVES


Breast cancer (BC) is the most diagnosed cancer in women. Increasing survival rates shift attention to preventive strategies. Obesity and intestinal microbiota composition may be associated with BC. A Mediterranean diet (MD) proved to be protective. The aim of this study was to assess the efficacy of probiotics in addition to an MD versus diet alone in influencing gut microbiota and metabolic profile in overweight BC survivors.
METHODS


A total of 34 BC survivors were randomly assigned to an MD for 4 mo plus 1 sachet/d of probiotics (Bifidobacterium longum BB536, Lactobacillus rhamnosus HN001) for the first 2 mo (intervention group, n = 16) or an MD alone for 4 mo (control group, n = 18). Anthropometric and nutritional assessments, adherence to the MD, compliance with physical activity, and metabolic parameters dosage were performed at baseline (T0), at 2 mo (T2), and at 4 mo (T4). Intestinal microbiota analysis was performed at T0 and T2.
RESULTS


After 2 mo of probiotic administration the number of bacterial species (P = 0.01) and the bacterial diversity assessed with the Chao1 index (P = 0.004) significantly increased; no significant variations were detected after diet alone. The Bacteroidetes-to-Firmicutes ratio significantly decreased in the intervention group and increased in controls (P = 0.004). Significant reductions of body weight, body mass index, fasting glucose, and homeostasis model assessment of insulin resistance were identified at T4 in both groups; in the intervention group waist circumference (P = 0.012), waist-to-hip ratio (P = 0.045), and fasting insulin (P = 0.017) also significantly decreased.
CONCLUSIONS


Probiotics in addition to an MD positively influence gut microbiota and improve metabolic and anthropometric parameters compared with an MD alone.",2020,After 2 mo of probiotic administration the number of bacterial species (P = 0.01) and the bacterial diversity assessed with the Chao1 index (P = 0.004) significantly increased; no significant variations were detected after diet alone.,"['diagnosed cancer in women', '34 BC survivors', 'overweight BC survivors', 'overweight breast cancer survivors']","['MD for 4 mo plus 1 sachet/d of probiotics (Bifidobacterium longum BB536, Lactobacillus rhamnosus HN001', 'Mediterranean diet (MD', 'MD alone', 'MD versus diet alone']","['gut microbiota and metabolic profile', 'Obesity and intestinal microbiota composition', 'number of bacterial species', 'fasting insulin', 'bacterial diversity assessed with the Chao1 index', 'Bacteroidetes-to-Firmicutes ratio', 'body weight, body mass index, fasting glucose, and homeostasis model assessment of insulin resistance', 'waist-to-hip ratio', 'Anthropometric and nutritional assessments, adherence to the MD, compliance with physical activity, and metabolic parameters dosage', 'Gut microbiota composition', 'metabolic and anthropometric parameters', 'Intestinal microbiota analysis']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2348127', 'cui_str': 'Sachet - unit of product usage'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0314977', 'cui_str': 'Bifidobacterium longum'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0028708', 'cui_str': 'Assessment of nutritional status'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",34.0,0.0359041,After 2 mo of probiotic administration the number of bacterial species (P = 0.01) and the bacterial diversity assessed with the Chao1 index (P = 0.004) significantly increased; no significant variations were detected after diet alone.,"[{'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Pellegrini', 'Affiliation': 'Department of Clinical Nutrition, Città della Salute e della Scienza, Turin, Italy.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Ippolito', 'Affiliation': 'Department of Clinical Nutrition, Città della Salute e della Scienza, Turin, Italy.'}, {'ForeName': 'Taira', 'Initials': 'T', 'LastName': 'Monge', 'Affiliation': 'Department of Clinical Nutrition, Città della Salute e della Scienza, Turin, Italy.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Violi', 'Affiliation': 'Department of Clinical Nutrition, Città della Salute e della Scienza, Turin, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Cappello', 'Affiliation': 'CeRMS Labortory of Tumor Immunology, University of Turin, Italy.'}, {'ForeName': 'Ilario', 'Initials': 'I', 'LastName': 'Ferrocino', 'Affiliation': 'Department of Agricultural, Forest and Food Sciences, University of Turin, Italy.'}, {'ForeName': 'Luca Simone', 'Initials': 'LS', 'LastName': 'Cocolin', 'Affiliation': 'Department of Agricultural, Forest and Food Sciences, University of Turin, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'De Francesco', 'Affiliation': 'Department of Clinical Nutrition, Città della Salute e della Scienza, Turin, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Bo', 'Affiliation': 'Department of Medical Science, University of Turin, Italy.'}, {'ForeName': 'Concetta', 'Initials': 'C', 'LastName': 'Finocchiaro', 'Affiliation': 'Department of Clinical Nutrition, Città della Salute e della Scienza, Turin, Italy. Electronic address: cfinocchiaro@cittadellasalute.to.it.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110749']
489,32234653,Adequacy and safety of α-lactalbumin-enriched low-protein infant formula: A randomized controlled trial.,"OBJECTIVES


The aim of this study was to demonstrate suitability and safety of an infant formula enriched with α-lactalbumin with a reduced protein content of 1.89 g protein/100 kcal.
METHODS


This was a randomized, double-blind controlled trial with 80 healthy newborn infants who were assigned to receive either an isocaloric low- or high-protein content formula (1.89 versus 2.1 g/100 kcal). The low-protein content formula was enriched with α-lactalbumin. A breast-fed reference group of 40 infants was studied concurrently. Anthropometric measures were taken at inclusion, after 6 and 12 wk as well as after 6 and 12 mo of follow-up. Primary outcome was weight gain in g/d between study inclusion to 12 wk. Secondary outcomes included anthropometric measures expressed in Z-scores, mean formula consumption, and caloric intake as well as food tolerance.
RESULTS


Fifty-two infants in the formula group (low protein: 26, high protein: 26) and 32 in the breast-fed reference group completed the 3-mo intervention period. There was no difference in weight gain among feeding groups at the end of the intervention period. Mean weight gain in g/d was 32 in the low-protein, 31 in the high-protein, and 33 in the breast-fed reference group. No significant difference was found between study groups in Z-scores for weight, length, head circumference, weight-for-length, or body mass index nor for fat percentage at end of intervention and after follow-up.
CONCLUSION


α-lactalbumin-enriched formula with a protein content of 1.89 g protein/100 kcal is safe and supports adequate growth.",2020,"No significant difference was found between study groups in Z-scores for weight, length, head circumference, weight-for-length, or body mass index nor for fat percentage at end of intervention and after follow-up.
","['Fifty-two infants in the formula group (low protein: 26, high protein: 26) and 32 in the breast-fed reference group completed the 3-mo intervention period', '80 healthy newborn infants']","['α-lactalbumin', 'isocaloric low- or high-protein content formula', 'α-lactalbumin-enriched low-protein infant formula']","['weight gain', 'Z-scores for weight, length, head circumference, weight-for-length, or body mass index nor for fat percentage', 'anthropometric measures expressed in Z-scores, mean formula consumption, and caloric intake as well as food tolerance', 'Mean weight gain']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0578757', 'cui_str': 'Good neonatal condition at birth'}]","[{'cui': 'C0022912', 'cui_str': 'Lactalbumin'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",80.0,0.177549,"No significant difference was found between study groups in Z-scores for weight, length, head circumference, weight-for-length, or body mass index nor for fat percentage at end of intervention and after follow-up.
","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Petersen', 'Affiliation': 'Department of Pediatrics, Evangelisches Waldkrankenhaus Spandau, Berlin, Germany. Electronic address: Hanna.Petersen@jsd.de.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Nomayo', 'Affiliation': 'Department of Pediatrics, Evangelisches Waldkrankenhaus Spandau, Berlin, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Zelenka', 'Affiliation': 'DMK Baby GmbH, Bremen, Germany.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Foster', 'Affiliation': 'Department of Pediatrics, Evangelisches Waldkrankenhaus Spandau, Berlin, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Tvrdík', 'Affiliation': 'Department of Computer Sciences, University of Ostrava, Czech Republic.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Jochum', 'Affiliation': 'Department of Pediatrics, Evangelisches Waldkrankenhaus Spandau, Berlin, Germany.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110728']
490,30267045,Effect of Foster Care Intervention on Trajectories of General and Specific Psychopathology Among Children With Histories of Institutional Rearing: A Randomized Clinical Trial.,"Importance


It is unclear whether early institutional rearing is associated with more problematic trajectories of psychopathology from childhood to adolescence and whether assignment to foster care mitigates this risk.
Objectives


To examine trajectories of latent psychopathology factors-general (P), internalizing (INT), and externalizing (EXT)-among children reared in institutions and to evaluate whether randomization to foster care is associated with reductions in psychopathology from middle childhood through adolescence.
Design, Setting, and Participants


This longitudinal, intent-to-treat randomized clinical trial was conducted in Bucharest, Romania, where children residing in 6 institutions underwent baseline testing and were then randomly assigned to a care as usual group (CAUG) or a foster care group (FCG). A matched sample of a never-institutionalized group (NIG) was recruited to serve as a comparison group. The study commenced in April 2001, and the most recent (age 16 years) follow-up started in January 2015 and is ongoing.
Intervention


Institutionally reared children randomized to high-quality foster homes.
Main Outcomes and Measures


Psychopathology was measured using the MacArthur Health and Behavior Questionnaire. Teachers and/or caregivers reported on symptoms of psychopathology in several domains.
Results


A total of 220 children (50.0% female; 119 ever institutionalized) were included in the analysis at the mean ages of 8, 12, and 16 years. A latent bifactor model with general (P) and specific internalizing (INT) and externalizing (EXT) factors offered a good fit to the data. At age 8 years, CAUG (mean, 0.41; 95% CI, 0.17-0.67) and FCG (mean, 0.30; 95% CI, 0.04-0.53) had higher P than NIG (mean, -0.40; 95% CI, -0.56 to -0.18). By age 16 years, FCG (mean, 0.07; 95% CI, -0.18 to 0.29) had lower P than CAUG (mean, 0.37; 95% CI, 0.13-0.60). This effect was likely driven by modest declines in P from age 8 years to age 16 years among FCG (slope, -0.12; 95% CI, -0.26 to 0.04) compared with CAUG, who remained stably high over this period (slope, -0.02; 95% CI, -0.19 to 0.14). Moreover, CAUG and FCG showed increasing divergence in EXT over time, such that FCG (mean, -0.30; 95% CI, -0.58 to -0.02) had fewer problems than CAUG (mean, 0.05; 95% CI, -0.25 to 0.36) by age 16 years. No INT differences were observed.
Conclusions and Relevance


Institutionalization increases transdiagnostic vulnerability to psychopathology from childhood to adolescence, a period of significant social and biological change. Early assignment to foster care partially mitigates this risk, thus highlighting the importance of social enrichment in buffering the effects of severe early neglect on trajectories of psychopathology.
Trial Registration


ClinicalTrials.gov Identifier: NCT00747396.",2018,"By age 16 years, FCG (mean, 0.07; 95% CI, -0.18 to 0.29) had lower P than CAUG (mean, 0.37; 95% CI, 0.13-0.60).","['With Histories of Institutional Rearing', '220 children (50.0% female; 119 ever institutionalized) were included in the analysis at the mean ages of 8, 12, and 16 years', 'April 2001, and the most recent (age 16 years) follow-up started in January 2015 and is ongoing', 'A matched sample of a never-institutionalized group (NIG', 'Bucharest, Romania, where children residing in 6 institutions underwent baseline testing', 'Children']","['care as usual group (CAUG) or a foster care group (FCG', 'Foster Care Intervention']","['specific internalizing (INT) and externalizing (EXT) factors', 'Trajectories of General and Specific Psychopathology', 'MacArthur Health and Behavior Questionnaire', 'Measures\n\n\nPsychopathology', 'FCG', 'latent psychopathology factors-general (P), internalizing (INT), and externalizing']","[{'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0035826', 'cui_str': 'Romania'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0580718', 'cui_str': 'Foster care procedures (procedure)'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}]",220.0,0.107497,"By age 16 years, FCG (mean, 0.07; 95% CI, -0.18 to 0.29) had lower P than CAUG (mean, 0.37; 95% CI, 0.13-0.60).","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wade', 'Affiliation': ""Division of Developmental Medicine, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Fox', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Zeanah', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Tulane University School of Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nelson', 'Affiliation': ""Division of Developmental Medicine, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",JAMA psychiatry,['10.1001/jamapsychiatry.2018.2556']
491,31089727,An electronic health record-based interoperable eReferral system to enhance smoking Quitline treatment in primary care.,"OBJECTIVE


The study sought to determine whether interoperable, electronic health record-based referral (eReferral) produces higher rates of referral and connection to a state tobacco quitline than does fax-based referral, thus addressing low rates of smoking treatment delivery in health care.
MATERIALS AND METHODS


Twenty-three primary care clinics from 2 healthcare systems (A and B) in Wisconsin were randomized, unblinded, over 2016-2017, to 2 smoking treatment referral methods: paper-based fax-to-quit (system A =6, system B = 6) or electronic (eReferral; system A = 5, system B = 6). Both methods referred adult patients who smoked to the Wisconsin Tobacco Quitline. A total of 14 636 smokers were seen in the 2 systems (system A: 54.5% women, mean age 48.2 years; system B: 53.8% women, mean age 50.2 years).
RESULTS


Clinics with eReferral, vs fax-to-quit, referred a higher percentage of adult smokers to the quitline: system A clinic referral rate = 17.9% (95% confidence interval [CI], 17.2%-18.5%) vs 3.8% (95% CI, 3.5%-4.2%) (P < .001); system B clinic referral rate = 18.9% (95% CI, 18.3%-19.6%) vs 5.2% (95% CI, 4.9%-5.6%) (P < .001). Average rates of quitline connection were higher in eReferral than F2Q clinics: system A = 5.4% (95% CI, 5.0%-5.8%) vs 1.3% (95% CI, 1.1%-1.5%) (P < .001); system B = 5.3% (95% CI, 5.0%-5.7%) vs 2.0% (95% CI, 1.8%-2.2%) (P < .001).
DISCUSSION


Electronic health record-based eReferral provided an effective, closed-loop, interoperable means of referring patients who smoke to telephone quitline services, producing referral rates 3-4 times higher than the current standard of care (fax referral), including especially high rates of referral of underserved individuals.
CONCLUSIONS


eReferral may help address the challenge of providing smokers with treatment for tobacco use during busy primary care visits.ClinicalTrials.gov; No. NCT02735382.",2019,Average rates of quitline connection were higher in eReferral than F2Q clinics,"['primary care', 'Twenty-three primary care clinics from 2 healthcare systems (A and B) in Wisconsin were randomized, unblinded, over 2016-2017, to 2', 'A total of 14 636 smokers were seen in the 2 systems (system A: 54.5% women, mean age 48.2 years; system B: 53.8% women, mean age 50.2 years', 'adult patients who smoked to the Wisconsin Tobacco Quitline']","['smoking treatment referral methods: paper-based fax-to-quit (system A =6, system B = 6) or electronic (eReferral; system A = 5, system B = 6', 'interoperable, electronic health record-based referral (eReferral']","['Average rates of quitline connection', 'system B clinic referral rate']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085205', 'cui_str': 'Fax'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}]","[{'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}]",14636.0,0.187087,Average rates of quitline connection were higher in eReferral than F2Q clinics,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fiore', 'Affiliation': 'Center for Tobacco Research and Intervention and Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Adsit', 'Affiliation': 'Center for Tobacco Research and Intervention and Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Zehner', 'Affiliation': 'Center for Tobacco Research and Intervention and Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'McCarthy', 'Affiliation': 'Center for Tobacco Research and Intervention and Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Lundsten', 'Affiliation': 'Department of Community and Preventive Care Services, Gundersen Health System, La Crosse, Wisconsin, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hartlaub', 'Affiliation': 'Family and Preventive Medicine, Brown Deer, Quality and Safety, Primary Care, Ascension Medical Group, Brown Deer, Wisconsin, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Mahr', 'Affiliation': 'Department of Community and Preventive Care Services, Gundersen Health System, La Crosse, Wisconsin, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Gorrilla', 'Affiliation': 'Center for Tobacco Research and Intervention and Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Skora', 'Affiliation': 'Center for Tobacco Research and Intervention and Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Baker', 'Affiliation': 'Center for Tobacco Research and Intervention and Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocz044']
492,31207561,Health-related quality of life in remitted psychotic depression ✰ .,"BACKGROUND


Some patients with major depression continue to demonstrate deficits in health-related quality of life (HRQL) following remission. No data exist, however, regarding HRQL in remitted psychotic depression. In this study, we aimed to characterize HRQL in patients with psychotic depression receiving controlled pharmacotherapy.
METHODS


This is a secondary analysis of a randomized controlled trial studying continuation pharmacotherapy of psychotic depression. We compared participants' HRQL (measured using the SF-36) between baseline and remission and to population norms. We also compared SF-36 scores stratified by age and gender and examined the correlation between SF-36 scores and medical burden, depression score and neuropsychological performance in remission.
RESULTS


SF-36 scores were significantly lower than population norms at baseline, but improved following remission to the level of population norms. Neither SF-36 scores nor magnitude of SF-36 improvement differed substantially between genders or between younger and older participants. In remission, depression scores were correlated with most SF-36 scales and medical burden was correlated with SF-36 scales measuring physical symptoms. Neuropsychological measures were generally not correlated with SF-36 scores.
LIMITATIONS


This study was a secondary analysis not powered specifically to measure HRQL as an outcome variable and the SF-36 was the only HRQL measure used.
CONCLUSIONS


Participants with remitted psychotic depression demonstrated levels of HRQL comparable to population norms, despite marked impairment in HRQL when acutely ill. This finding suggests that, when treated in a rigorous manner, many patients with this severe illness improve significantly from a clinical and HRQL perspective.",2019,Neither SF-36 scores nor magnitude of SF-36 improvement differed substantially between genders or between younger and older participants.,"['patients with major depression', 'psychotic depression', 'patients with psychotic depression receiving controlled pharmacotherapy', 'remitted psychotic depression ✰ ']",['HRQL'],"['SF-36 scores nor magnitude of SF-36 improvement', 'SF-36 scales and medical burden', 'Neuropsychological measures', 'SF-36 scores and medical burden, depression score and neuropsychological performance in remission', 'remission, depression scores', 'SF-36 scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0270458', 'cui_str': 'Severe major depression with psychotic features'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.132489,Neither SF-36 scores nor magnitude of SF-36 improvement differed substantially between genders or between younger and older participants.,"[{'ForeName': 'Kathleen S', 'Initials': 'KS', 'LastName': 'Bingham', 'Affiliation': 'University of Toronto, Department of Psychiatry, Toronto, ON, Canada. Electronic address: kathleen.bingham@uhn.ca.'}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Whyte', 'Affiliation': 'University of Pittsburgh School of Medicine, Department of Psychiatry, Pittsburgh, PA, United States.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'University of Toronto, Department of Psychiatry, Toronto, ON, Canada; Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Rothschild', 'Affiliation': 'University of Massachusetts Medical School, Department of Psychiatry, Worcester, MA, United States.'}, {'ForeName': 'Matthew V', 'Initials': 'MV', 'LastName': 'Rudorfer', 'Affiliation': 'National Institute of Mental Health, Rockville, MD, United States.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Marino', 'Affiliation': 'Weill Cornell Medical College, Department of Psychiatry, New York, NY, United States.'}, {'ForeName': 'Samprit', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Weill Cornell Medical College, Department of Biostatistics and Epidemiology, New York, NY, United States.'}, {'ForeName': 'Meryl A', 'Initials': 'MA', 'LastName': 'Butters', 'Affiliation': 'University of Pittsburgh School of Medicine, Department of Psychiatry, Pittsburgh, PA, United States.'}, {'ForeName': 'George S', 'Initials': 'GS', 'LastName': 'Alexopoulos', 'Affiliation': 'Weill Cornell Medicine, New York-Presbyterian/Westchester Division, White Plains, NY, United States.'}, {'ForeName': 'Barnett S', 'Initials': 'BS', 'LastName': 'Meyers', 'Affiliation': 'Weill Cornell Medicine, New York-Presbyterian/Westchester Division, White Plains, NY, United States.'}, {'ForeName': 'Alastair J', 'Initials': 'AJ', 'LastName': 'Flint', 'Affiliation': 'University of Toronto, Department of Psychiatry, Toronto, ON, Canada; University Health Network, Toronto, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of affective disorders,['10.1016/j.jad.2019.05.068']
493,30946478,Can menstrual health apps selected based on users' needs change health-related factors? A double-blind randomized controlled trial.,"OBJECTIVE


Most healthcare providers are reluctant to use health apps for healthcare because there is no rigorous way of choosing the best app for their patient or consumer. Accordingly, we developed a new method of app selection that fully considers target users' needs. This study verified whether health apps selected based on target users' needs can influence health-related factors.
MATERIALS AND METHODS


We conducted a randomized control trial of women with dysmenorrhea and premenstrual syndrome using App A (the best app selected using the new method) and App B (the app with the highest number of users worldwide). The intervention was performed over 4 months to include at least 3 menstrual cycles.
RESULTS


Sixty-one app users completed the 16-week intervention. While users rated both apps as higher in quality than previously used menstrual apps, only App A users showed significant improvements in overall satisfaction, app outcome expectancy, the number of days with records, app social influence, intent to recommend, and the possibility of behavioral or cognitive changes in their symptom management. The number of menus used increased over time. While the app self-efficacy and the number of relief methods did not significantly differ between groups, they still showed an increase in App A users.
CONCLUSIONS


When a menstrual app reflected users' needs, they recorded their symptoms more often and reported higher app quality, satisfaction, and intention to recommend. This study can not only benefit the selection of menstrual apps, but also confirm that mobile health apps can improve health-related factors.",2019,"While the app self-efficacy and the number of relief methods did not significantly differ between groups, they still showed an increase in App A users.
","['Sixty-one app users completed the 16-week intervention', 'women with dysmenorrhea and premenstrual syndrome using App A (the best app selected using the new method) and App B (the app with the highest number of users worldwide']",[],"['number of relief methods', 'number of menus used increased over time', 'overall satisfaction']","[{'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C0033046', 'cui_str': 'PMS - Premenstrual syndrome'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",61.0,0.373608,"While the app self-efficacy and the number of relief methods did not significantly differ between groups, they still showed an increase in App A users.
","[{'ForeName': 'Jisan', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing science, College of Life & Health Sciences, Hoseo University, Asan, Korea.'}, {'ForeName': 'Jeongeun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Interdisciplinary Program of Medical Informatics, Seoul National University, Seoul, Korea.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocz019']
494,31488103,Dynamic Interactive Social Cognition Training in Virtual Reality (DiSCoVR) for social cognition and social functioning in people with a psychotic disorder: study protocol for a multicenter randomized controlled trial.,"BACKGROUND


Problems in social functioning (e.g., unemployment, social isolation), are common in people with a psychotic disorder. Social cognition is a treatment target to improve social functioning, as it is a proximal predictor of social functioning. Social Cognition Training (SCT) improves social cognition, but may not generalize (enduringly) to social functioning, perhaps due to insufficient opportunity to practice in daily-life social situations. Using virtual reality (VR) for SCT could address this problem, as VR is customizable, accessible, and interactive. We will test the effect of a VR SCT, 'DiSCoVR', on social cognition and social functioning in a randomized controlled trial (RCT).
METHODS


In total 100 people with a psychotic disorder and deficits in social cognition will be recruited for this multicenter randomized controlled trial (RCT). Participants will be randomized to VR SCT (DiSCoVR) or VR relaxation training (VRelax; active control). DiSCoVR is a 16-session individual SCT, consisting of three modules: 1) emotion perception (recognizing facial emotions in a virtual shopping street); 2) social perception and theory of mind (observing social interactions between virtual characters and assessing their behavior, emotions and thoughts); and 3) application of higher-order social cognition in social interaction (role-playing personalized situations in VR). People receiving VRelax complete sixteen individual sessions, in which they receive psycho-education about stress, identify personal stressors, learn relaxation techniques, and explore relaxing immersive virtual environments. Assessments will be performed at baseline, post-treatment, and 3-month follow-up. Primary outcomes are emotion perception (Ekman 60 Faces), social perception and theory of mind (The Awareness of Social Inference Test). Secondary outcomes include social functioning (Personal and Social Performance Scale), experiences and social interactions in daily life (experience sampling of emotions, social participation and subjective experience of social situations), psychiatric symptoms (e.g., depression, perceived stress, anxiety, positive and negative symptoms) and self-esteem.
DISCUSSION


To our knowledge, this will be the first RCT testing the efficacy of VR SCT. It will also investigate generalization to daily life social situations, the durability of treatment effects, and moderators and mediators of treatment success.
TRIAL REGISTRATION


On December 5, 2017, this trial was registered prospectively in the Dutch Trial Register as NTR6863 .",2019,"Social Cognition Training (SCT) improves social cognition, but may not generalize (enduringly) to social functioning, perhaps due to insufficient opportunity to practice in daily-life social situations.","['people with a psychotic disorder', 'In total 100 people with a psychotic disorder and deficits in social cognition']","['Dynamic Interactive Social Cognition Training in Virtual Reality (DiSCoVR', 'DiSCoVR', 'VR SCT (DiSCoVR) or VR relaxation training (VRelax; active control', ""VR SCT, 'DiSCoVR"", 'Social Cognition Training (SCT']","['emotion perception (Ekman 60 Faces), social perception and theory of mind (The Awareness of Social Inference Test', 'social cognition and social functioning', 'social functioning (Personal and Social Performance Scale), experiences and social interactions in daily life (experience sampling of emotions, social participation and subjective experience of social situations), psychiatric symptoms (e.g., depression, perceived stress, anxiety, positive and negative symptoms) and self-esteem', 'social cognition']","[{'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0282333', 'cui_str': 'Relaxation Therapy'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0037427', 'cui_str': 'Social Perception'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0222045'}, {'cui': 'C0037420', 'cui_str': 'Social Interaction'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C4279973', 'cui_str': 'Experience Sampling'}, {'cui': 'C0814554', 'cui_str': 'Social Participation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}]",,0.0465154,"Social Cognition Training (SCT) improves social cognition, but may not generalize (enduringly) to social functioning, perhaps due to insufficient opportunity to practice in daily-life social situations.","[{'ForeName': 'Saskia A', 'Initials': 'SA', 'LastName': 'Nijman', 'Affiliation': 'Department of Psychotic Disorders, GGZ Drenthe, Dennenweg 9, PO Box 30007, 9404, LA, Assen, the Netherlands. s.a.nijman@umcg.nl.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Veling', 'Affiliation': 'University Center of Psychiatry, University Medical Center Groningen, University of Groningen, Hanzeplein 1, PO Box 30.001, 9700, RB, Groningen, the Netherlands.'}, {'ForeName': 'Kirstin', 'Initials': 'K', 'LastName': 'Greaves-Lord', 'Affiliation': 'Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia, Wytemaweg 8, 3015, CN, Rotterdam, The Netherlands.'}, {'ForeName': 'Rowina R', 'Initials': 'RR', 'LastName': 'Vermeer', 'Affiliation': 'Flexible Assertive Community Treatment Team, Outpatient Treatment Center, GGZ Delfland, Sint Jorisweg 2, 2612, GA, Delft, The Netherlands.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Vos', 'Affiliation': 'University Center of Psychiatry, University Medical Center Groningen, University of Groningen, Hanzeplein 1, PO Box 30.001, 9700, RB, Groningen, the Netherlands.'}, {'ForeName': 'Catharina E R', 'Initials': 'CER', 'LastName': 'Zandee', 'Affiliation': 'Flexible Assertive Community Treatment Team, Outpatient Treatment Center, GGZ Delfland, Sint Jorisweg 2, 2612, GA, Delft, The Netherlands.'}, {'ForeName': 'Daniëlle C', 'Initials': 'DC', 'LastName': 'Zandstra', 'Affiliation': 'Zeeuwse Gronden, Axelsestraat 8/A, 4537, AJ, Terneuzen, The Netherlands.'}, {'ForeName': 'Chris N W', 'Initials': 'CNW', 'LastName': 'Geraets', 'Affiliation': 'University Center of Psychiatry, University Medical Center Groningen, University of Groningen, Hanzeplein 1, PO Box 30.001, 9700, RB, Groningen, the Netherlands.'}, {'ForeName': 'Gerdina H M', 'Initials': 'GHM', 'LastName': 'Pijnenborg', 'Affiliation': 'Department of Psychotic Disorders, GGZ Drenthe, Dennenweg 9, PO Box 30007, 9404, LA, Assen, the Netherlands.'}]",BMC psychiatry,['10.1186/s12888-019-2250-0']
495,31488144,"A minimum evaluation protocol and stepped-wedge cluster randomized trial of ACCESS Open Minds, a large Canadian youth mental health services transformation project.","BACKGROUND


Many Canadian adolescents and young adults with mental health problems face delayed detection, long waiting lists, poorly accessible services, care of inconsistent quality and abrupt or absent inter-service transitions. To address these issues, ACCESS Open Minds, a multi-stakeholder network, is implementing and systematically evaluating a transformation of mental health services for youth aged 11 to 25 at 14 sites across Canada. The transformation plan has five key foci: early identification, rapid access, appropriate care, the elimination of age-based transitions between services, and the engagement of youth and families.
METHODS


The ACCESS Open Minds Research Protocol has multiple components including a minimum evaluation protocol and a stepped-wedge cluster randomized trial, that are detailed in this paper. Additional components include qualitative methods and cost-effectiveness analyses. The services transformation is being evaluated at all sites via a minimum evaluation protocol. Six sites are participating in the stepped-wedge trial whereby the intervention (a service transformation along the key foci) was rolled out in three waves, each commencing six months apart. Two sites, one high-population and one low-population, were randomly assigned to each of the three waves, i.e., randomization was stratified by population size. Our primary hypotheses pertain to increased referral numbers, and reduced wait times to initial assessment and to the commencement of appropriate care. Secondary hypotheses pertain to simplified pathways to care; improved clinical, functional and subjective outcomes; and increased satisfaction among youth and families. Quantitative measures addressing these hypotheses are being used to determine the effectiveness of the intervention.
DISCUSSION


Data from our overall research strategy will help test the effectiveness of the ACCESS Open Minds transformation, refine it further, and inform its scale-up. The process by which our research strategy was developed has implications for the practice of research itself in that it highlights the need to actively engage all stakeholder groups and address unique considerations in designing evaluations of complex healthcare interventions in multiple, diverse contexts. Our approach will generate both concrete evidence and nuanced insights, including about the challenges of conducting research in real-world settings. More such innovative approaches are needed to advance youth mental health services research.
TRIAL REGISTRATION NUMBER


Clinicaltrials.gov, ISRCTN23349893 (Retrospectively registered: 16/02/2017).",2019,"Secondary hypotheses pertain to simplified pathways to care; improved clinical, functional and subjective outcomes; and increased satisfaction among youth and families.","['Two sites, one high-population and one low-population', 'youth aged 11 to 25 at 14 sites across Canada', 'large Canadian youth mental health services transformation project', 'Canadian adolescents and young adults with mental health problems']",[],[],"[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C3714584', 'cui_str': 'Transformation, function (observable entity)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}]",[],[],,0.0824206,"Secondary hypotheses pertain to simplified pathways to care; improved clinical, functional and subjective outcomes; and increased satisfaction among youth and families.","[{'ForeName': 'Srividya N', 'Initials': 'SN', 'LastName': 'Iyer', 'Affiliation': 'Department of Psychiatry, McGill University, Montréal, Québec, Canada. srividya.iyer@mcgill.ca.'}, {'ForeName': 'Jai', 'Initials': 'J', 'LastName': 'Shah', 'Affiliation': 'Department of Psychiatry, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Boksa', 'Affiliation': 'Department of Psychiatry, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Lal', 'Affiliation': 'ACCESS Open Minds (Pan-Canadian Youth Mental Health Services Research Network), Douglas Mental Health University Institute, Montréal, Québec, Canada.'}, {'ForeName': 'Ridha', 'Initials': 'R', 'LastName': 'Joober', 'Affiliation': 'Department of Psychiatry, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Andersson', 'Affiliation': 'ACCESS Open Minds (Pan-Canadian Youth Mental Health Services Research Network), Douglas Mental Health University Institute, Montréal, Québec, Canada.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Fuhrer', 'Affiliation': 'ACCESS Open Minds (Pan-Canadian Youth Mental Health Services Research Network), Douglas Mental Health University Institute, Montréal, Québec, Canada.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Abdel-Baki', 'Affiliation': 'ACCESS Open Minds (Pan-Canadian Youth Mental Health Services Research Network), Douglas Mental Health University Institute, Montréal, Québec, Canada.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Beaton', 'Affiliation': 'ACCESS Open Minds (Pan-Canadian Youth Mental Health Services Research Network), Douglas Mental Health University Institute, Montréal, Québec, Canada.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Reaume-Zimmer', 'Affiliation': 'ACCESS Open Minds (Pan-Canadian Youth Mental Health Services Research Network), Douglas Mental Health University Institute, Montréal, Québec, Canada.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Hutt-MacLeod', 'Affiliation': 'ACCESS Open Minds (Pan-Canadian Youth Mental Health Services Research Network), Douglas Mental Health University Institute, Montréal, Québec, Canada.'}, {'ForeName': 'Mary Anne', 'Initials': 'MA', 'LastName': 'Levasseur', 'Affiliation': 'ACCESS Open Minds (Pan-Canadian Youth Mental Health Services Research Network), Douglas Mental Health University Institute, Montréal, Québec, Canada.'}, {'ForeName': 'Ranjith', 'Initials': 'R', 'LastName': 'Chandrasena', 'Affiliation': 'ACCESS Open Minds (Pan-Canadian Youth Mental Health Services Research Network), Douglas Mental Health University Institute, Montréal, Québec, Canada.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Rousseau', 'Affiliation': 'Department of Psychiatry, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Torrie', 'Affiliation': 'ACCESS Open Minds (Pan-Canadian Youth Mental Health Services Research Network), Douglas Mental Health University Institute, Montréal, Québec, Canada.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Etter', 'Affiliation': 'ACCESS Open Minds (Pan-Canadian Youth Mental Health Services Research Network), Douglas Mental Health University Institute, Montréal, Québec, Canada.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Vallianatos', 'Affiliation': 'ACCESS Open Minds (Pan-Canadian Youth Mental Health Services Research Network), Douglas Mental Health University Institute, Montréal, Québec, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Abba-Aji', 'Affiliation': 'ACCESS Open Minds (Pan-Canadian Youth Mental Health Services Research Network), Douglas Mental Health University Institute, Montréal, Québec, Canada.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Bighead', 'Affiliation': 'ACCESS Open Minds (Pan-Canadian Youth Mental Health Services Research Network), Douglas Mental Health University Institute, Montréal, Québec, Canada.'}, {'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'MacKinnon', 'Affiliation': 'ACCESS Open Minds (Pan-Canadian Youth Mental Health Services Research Network), Douglas Mental Health University Institute, Montréal, Québec, Canada.'}, {'ForeName': 'Ashok K', 'Initials': 'AK', 'LastName': 'Malla', 'Affiliation': 'Department of Psychiatry, McGill University, Montréal, Québec, Canada.'}]",BMC psychiatry,['10.1186/s12888-019-2232-2']
496,31429023,HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in herniorrhaphy: results from the phase 3 EPOCH 2 study.,"PURPOSE


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


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


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


HTX-011 demonstrated significant improvement in postoperative pain control and a clinically meaningful reduction in opioid consumption when compared to the most widely used local anesthetic, bupivacaine HCl.",2019,reduced mean pain intensity by 23% versus placebo (primary endpoint; p < 0.001) and by 21% versus bupivacaine HCl (p < 0.001) with significant reductions in the number of patients experiencing severe pain.,"['herniorrhaphy', 'subjects undergoing']","['bupivacaine HCl and placebo', 'bupivacaine HCl', 'unilateral open inguinal herniorrhaphy with mesh placement', 'placebo', 'bupivacaine hydrochloride (HCl', 'HTX-011', 'HTX-011 (bupivacaine and meloxicam', 'single intraoperative dose of HTX-011, immediate-release bupivacaine HCl, or saline placebo']","['mean pain intensity', 'pain intensity and opioid consumption', 'Opioid consumption', 'opioid-free', 'postoperative pain control', 'safety and efficacy']","[{'cui': 'C0019328', 'cui_str': 'Hernia Repair'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0443985', 'cui_str': 'Flinders medical center-7 marker (substance)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0083381', 'cui_str': 'meloxicam'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",418.0,0.391164,reduced mean pain intensity by 23% versus placebo (primary endpoint; p < 0.001) and by 21% versus bupivacaine HCl (p < 0.001) with significant reductions in the number of patients experiencing severe pain.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Viscusi', 'Affiliation': 'Sidney Kimmel Medical College of Thomas Jefferson University, 111 South 11th Street, Gibbon Building, Suite 8490, Philadelphia, PA, 19107, USA. Eugene.Viscusi@jefferson.edu.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Minkowitz', 'Affiliation': 'HD Research Corp, Houston, TX, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Winkle', 'Affiliation': 'Anaheim Clinical Trials, Anaheim, CA, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ramamoorthy', 'Affiliation': 'University of California at San Diego Health System, San Diego, CA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Heron Therapeutics, Inc., San Diego, CA, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Singla', 'Affiliation': 'Lotus Clinical Research, LLC, Pasadena, CA, USA.'}]",Hernia : the journal of hernias and abdominal wall surgery,['10.1007/s10029-019-02023-6']
497,31726472,[Influence of Local Insufflation of Warm Humidified CO2 on the Wound Surface and Body Core Temperature as well as on Wound Healing in Open Colorectal Surgery].,"BACKGROUND


Perioperative hypothermia may lead to serious complications. This study aims to investigate whether intraoperative insufflation of warmed and humidified carbon dioxide (W-H-CO 2 ) into the open wound during open colorectal surgery influences body core and wound surface temperatures or the incidence of wound healing disorders (WHD).
METHODS


Between 02/2018 and 07/2019, 50 patients intended to undergo open resection for colorectal cancer were recruited and randomised to a control group (n = 25) and an experimental group (n = 25). In the experimental group, a device for insufflation of W-H-CO 2  was used. Body core and wound surface temperatures were recorded at the beginning and before finishing the procedure. IL-6 serum levels were determined preoperatively and during the postoperative course. Clinical observation of wound healing was performed until the 30th day post-op.
RESULTS


Both groups were homogeneous in terms of risk factors for WHD. In the control group, the median body core temperature (1. quartile/3. quartile) was 36.2 °C (36/36.4 °C) when the operation started and 36.2 °C (35.9/36.45 °C) at the end, while in the experimental group it was initially 36.2 °C (35.7/36.4 °C) and 36.4 °C (36/36.7 °C) at the end. There was no significant difference between the two groups (p = 0.08). The wound temperature in the control group dropped from 32.8 °C (median; 31.85/34.05 °C) to 30.7 °C (median; 29.85/32.15 °C). In the experimental group, we recorded a drop from 31.9 °C (median; 30.25/32.95 °C) to 31.6 °C (median; 30.25/31.85 °C), which was statistically significant (p = 0.000475). The dynamic of the IL-6 serum levels in both groups suggest that there was no significant difference (p = 0.66; p = 0.88; p = 0.88). In the control group, 8 patients experienced superficial WHD, 2 anastomotic leakages (AL), while in the experimental group, superficial WHD were observed in 5 patients and AL in 1 patient. This differences between the groups regarding in WHD were not significant (p = 0.42).
CONCLUSION


The established measures for prevention of perioperative hypothermia in elective procedures are sufficient. However, the local wound surface temperature is not preserved satisfactorily. Deployment of a device for intraoperative insufflation of W-H-CO 2  into open wounds may be suitable for maintaining local normothermia. Further studies are needed to determine the influence of warm and humid CO 2  on wound healing.",2020,IL-6,"['Open Colorectal Surgery', '50 patients intended to undergo open resection for colorectal cancer', 'Between 02/2018 and 07/2019']","['intraoperative insufflation of warmed and humidified carbon dioxide (W-H-CO 2 ', 'IL-6', 'Local Insufflation of Warm Humidified CO2']","['superficial WHD', 'Body core and wound surface temperatures', 'IL-6 serum levels', 'median body core temperature', 'wound healing', 'serum levels', 'wound temperature', 'superficial WHD, 2 anastomotic leakages (AL']","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C1143776', 'cui_str': 'cobalt(II) bis(2,2,6,6-tetramethylheptane-3,5-dionate)'}]","[{'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic Leakage'}]",50.0,0.0324764,IL-6,"[{'ForeName': 'Georgi', 'Initials': 'G', 'LastName': 'Kalev', 'Affiliation': 'Klinik für Allgemein-, Viszeral-, Thorax- und Kinderchirurgie, Klinikum Ludwigsburg, Deutschland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Egglseder', 'Affiliation': 'Klinik für Allgemein-, Viszeral-, Thorax- und Kinderchirurgie, Klinikum Ludwigsburg, Deutschland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Marquardt', 'Affiliation': 'Klinik für Allgemein-, Viszeral-, Thorax- und Kinderchirurgie, Klinikum Ludwigsburg, Deutschland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schiedeck', 'Affiliation': 'Klinik für Allgemein-, Viszeral-, Thorax- und Kinderchirurgie, Klinikum Ludwigsburg, Deutschland.'}]",Zentralblatt fur Chirurgie,['10.1055/a-1024-4702']
498,31891601,Evaluation of a savings-led family-based economic empowerment intervention for AIDS-affected adolescents in Uganda: A four-year follow-up on efficacy and cost-effectiveness.,"BACKGROUND


Children who have lost a parent to HIV/AIDS, known as AIDS orphans, face multiple stressors affecting their health and development. Family economic empowerment (FEE) interventions have the potential to improve these outcomes and mitigate the risks they face. We present efficacy and cost-effectiveness analyses of the Bridges study, a savings-led FEE intervention among AIDS-orphaned adolescents in Uganda at four-year follow-up.
METHODS


Intent-to-treat analyses using multilevel models compared the effects of two savings-led treatment arms: Bridges (1:1 matched incentive) and BridgesPLUS (2:1 matched incentive) to a usual care control group on the following outcomes: self-rated health, sexual health, and mental health functioning. Total per-participant costs for each arm were calculated using the treatment-on-the-treated sample. Intervention effects and per-participant costs were used to calculate incremental cost-effectiveness ratios (ICERs).
FINDINGS


Among 1,383 participants, 55% were female, 20% were double orphans. Mean age was 12 years at baseline. At 48-months, BridgesPLUS significantly improved self-rated health, (0.25, 95% CI 0.06, 0.43), HIV knowledge (0.21, 95% CI 0.01, 0.41), self-concept (0.26, 95% CI 0.09, 0.44), and self-efficacy (0.26, 95% CI 0.09, 0.43) and lowered hopelessness (-0.28, 95% CI -0.43, -0.12); whereas Bridges improved self-rated health (0.26, 95% CI 0.08, 0.43) and HIV knowledge (0.22, 95% CI 0.05, 0.39). ICERs ranged from $224 for hopelessness to $298 for HIV knowledge per 0.2 standard deviation change.
CONCLUSIONS


Most intervention effects were sustained in both treatment arms at two years post-intervention. Higher matching incentives yielded a significant and lasting effect on a greater number of outcomes among adolescents compared to lower matching incentives at a similar incremental cost per unit effect. These findings contribute to the evidence supporting the incorporation of FEE interventions within national social protection frameworks.",2019,Higher matching incentives yielded a significant and lasting effect on a greater number of outcomes among adolescents compared to lower matching incentives at a similar incremental cost per unit effect.,"['AIDS-affected adolescents in Uganda', 'AIDS-orphaned adolescents in Uganda at four-year follow-up', 'Mean age was 12 years at baseline', 'Children who have lost a parent to HIV/AIDS, known as AIDS orphans', '1,383 participants, 55% were female, 20% were double orphans']","['savings-led FEE intervention', 'two savings-led treatment arms: Bridges (1:1 matched incentive) and BridgesPLUS (2:1 matched incentive) to a usual care control group on the following outcomes: self-rated health, sexual health, and mental health functioning', 'savings-led family-based economic empowerment intervention']","['Total per-participant costs', 'ICERs', 'lowered hopelessness', 'efficacy and cost-effectiveness', 'incremental cost-effectiveness ratios (ICERs', 'self-rated health', 'HIV knowledge', 'self-efficacy', 'Bridges improved self-rated health']","[{'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0242299', 'cui_str': 'Orphans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}]","[{'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0015751', 'cui_str': 'Fees'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0150041', 'cui_str': 'Feeling of hopelessness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",1383.0,0.147934,Higher matching incentives yielded a significant and lasting effect on a greater number of outcomes among adolescents compared to lower matching incentives at a similar incremental cost per unit effect.,"[{'ForeName': 'Yesim', 'Initials': 'Y', 'LastName': 'Tozan', 'Affiliation': 'College of Global Public Health, New York University, New York, New York, United States of America.'}, {'ForeName': 'Sicong', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in Saint Louis, Saint Louis, Missouri, United States of America.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Capasso', 'Affiliation': 'College of Global Public Health, New York University, New York, New York, United States of America.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Shu-Huah Wang', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'Center for AIDS Prevention Studies, School of Medicine, University of California, San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'Ozge Sensoy', 'Initials': 'OS', 'LastName': 'Bahar', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in Saint Louis, Saint Louis, Missouri, United States of America.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Damulira', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in Saint Louis, Saint Louis, Missouri, United States of America.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in Saint Louis, Saint Louis, Missouri, United States of America.'}]",PloS one,['10.1371/journal.pone.0226809']
499,31600598,A two-part phase 1 study to establish and compare the safety and local tolerability of two nasal formulations of XF-73 for decolonisation of Staphylococcus aureus: A previously investigated 0.5mg/g viscosified gel formulation versus a modified formulation.,"OBJECTIVES


Successful decolonisation of nasal Staphylococcus aureus (SA) carriage by mupirocin is limited by increasing drug resistance. This randomised, open-label, phase 1 study compared the safety and local tolerability of two nasal formulations of XF-73, a novel porphyrinic antibacterial with rapid intrinsic activity against SA.
METHODS


The study was performed in 60 healthy adults. In Part 1, eight non-SA carriers were randomised to groups of four subjects each and were treated with XF-73 concentrations of 0.5mg/g 2% gel or 2.0mg/g 2% gel. In Part 2, 52 persistent SA carriers were randomised to groups of 13 subjects each and were treated with XF-73 concentrations of 0.5mg/g 2% gel, 2.0mg/g 2% gel, 0.5mg/g 4% gel or 4% viscosified placebo gel. Plasma pharmacokinetic and pharmacodynamic studies were performed. Antistaphylococcal activity was assessed as the presence/absence of SA and by quantification of colonisation using a semiquantitative scale (SA score).
RESULTS


56 subjects (8/8 from Part 1 and 48/52 from Part 2) completed the study, with 47/60 comprising the pharmacokinetic population and 48/60 the pharmacodynamic population. There was no measurable systemic absorption of XF-73. XF-73 treatment was associated with rapid reduction in SA score in all subjects. The most common treatment-emergent adverse events (TEAEs) were rhinorrhoea and nasal dryness (15.5% each in Parts 1 and 2). TEAEs were mild and resolved spontaneously.
CONCLUSION


XF-73 was well tolerated with minimal side effects at doses of 0.5mg/g 2% gel and 2.0mg/g 2% gel. These findings support further development of XF-73.",2019,"CONCLUSION


XF-73 was found to be safe and was tolerated with minimal side effects at doses of 0.5 mg/g 2% gel and 2 mg/g 2% gel in healthy volunteers.","['2 dosing cohorts, and enrolled 60 healthy adults', '56 subjects (8/8 from Part 1 and 48/52 from Part 2) completed the study, with 47/60 comprising the PK population and 48/60 the PD population', '52 healthy persistent SA carriers', 'Staphylococcus aureus', 'healthy volunteers']","['XF-73 in concentrations of 0.5\u2009mg/g 2% gel and 2\u2009mg/g 2% gel, respectively', 'XF-73', 'XF-73 (0.5\u2009mg/g 2% gel, 2\u2009mg/g 2% gel and 0.5\u2009mg/g 4% gel) or a 4% viscosified placebo gel']","['systemic absorption of XF-73', 'safety and local tolerability', 'Anti-staphylococcal activity', 'rhinorrhea and nasal dryness', 'SA scores', 'Plasma pharmacokinetics (PK) and pharmacodynamics (PD) studies']","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3850076', 'cui_str': 'Systemic Absorption'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1260880', 'cui_str': 'Nasal catarrh'}, {'cui': 'C0231919', 'cui_str': 'Nasal mucosa dry (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",60.0,0.0287411,"CONCLUSION


XF-73 was found to be safe and was tolerated with minimal side effects at doses of 0.5 mg/g 2% gel and 2 mg/g 2% gel in healthy volunteers.","[{'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Yendewa', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA. Electronic address: gay7@case.edu.'}, {'ForeName': 'J McLeod', 'Initials': 'JM', 'LastName': 'Griffiss', 'Affiliation': 'ClinicalRM, Hinckley, OH, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jacobs', 'Affiliation': 'Department of Pathology, Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Fulton', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': ""O'Riordan"", 'Affiliation': 'Department of Pediatrics, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Wesley A', 'Initials': 'WA', 'LastName': 'Gray', 'Affiliation': 'Department of Pediatrics, University of Toledo, Toledo, OH, USA.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Proskin', 'Affiliation': 'Howard M. Proskin and Associates, Incorporated, Rochester, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Winkle', 'Affiliation': 'Anaheim Clinical Trials, Anaheim, CA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Salata', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}]",Journal of global antimicrobial resistance,['10.1016/j.jgar.2019.09.017']
500,31500602,Clinical and cost-effectiveness of guided internet-based interventions in the indicated prevention of depression in green professions (PROD-A): study protocol of a 36-month follow-up pragmatic randomized controlled trial.,"BACKGROUND


People in green professions are exposed to a variety of risk factors, which could possibly enhance the development of depression. Amongst possible prevention approaches, internet- and mobile-based interventions (IMIs) have been shown to be effective and scalable. However, little is known about the effectiveness in green professions. The aim of the present study is to examine the (cost-)effectiveness of a tailored IMI program for reducing depressive symptoms and preventing the onset of clinical depression compared to enhanced treatment as usual (TAU+).
METHODS


A pragmatic randomized controlled trial (RCT) will be conducted to evaluate a tailored and therapeutically guided preventive IMI program in comparison to TAU+ with follow-ups at post-treatment (9 weeks), 6-, 12-, 24-, and 36-months. Entrepreneurs in green professions, collaborating spouses, family members and pensioners (N = 360) with sufficient insurance status and at least subthreshold depression (PHQ-9 ≥ 5) are eligible for inclusion. Primary outcome is depressive symptom severity (QIDS-SR16). Secondary outcomes include incidence of depression (QIDS-SR16), quality of life (AQoL-8D) and negative treatment effects (INEP). A health-economic evaluation will be conducted from a societal perspective. The IMI program is provided by psychologists of an external service company and consists of six guided IMIs (6-8 modules, duration: 6-8 weeks) targeting different symptoms (depressive mood, depressive mood with comorbid diabetes, perceived stress, insomnia, panic and agoraphobic symptoms or harmful alcohol use). Intervention choice depends on a screening of participants' symptoms and individual preferences. The intervention phase is followed by a 12-months consolidating phase with monthly contact to the e-coach.
DISCUSSION


This is the first pragmatic RCT investigating long-term effectiveness of a tailored guided IMI program for depression prevention in green professions. The present trial builds on a large-scale strategy for depression prevention in green professions. The intended implementation of the IMI program with a nationwide rollout has the potential to reduce overall depression burden and associated health care costs in case of given effectiveness.
TRIAL REGISTRATION


German Clinical Trial Registration: DRKS00014000 . Registered on 09 April 2018.",2019,"The intended implementation of the IMI program with a nationwide rollout has the potential to reduce overall depression burden and associated health care costs in case of given effectiveness.
","['Entrepreneurs in green professions, collaborating spouses, family members and pensioners (N\u2009=\u2009360) with sufficient insurance status and at least subthreshold depression (PHQ-9\u2009≥\u20095) are eligible for inclusion']","['guided internet-based interventions', 'tailored IMI program', 'guided IMI program']","['depressive symptoms', 'depressive symptom severity (QIDS-SR16', 'symptoms (depressive mood, depressive mood with comorbid diabetes, perceived stress, insomnia, panic and agoraphobic symptoms or harmful alcohol use', 'incidence of depression (QIDS-SR16), quality of life (AQoL-8D) and negative treatment effects (INEP']","[{'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C0162409', 'cui_str': 'Married Persons'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0376629', 'cui_str': 'Insurance Status'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034380'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.10438,"The intended implementation of the IMI program with a nationwide rollout has the potential to reduce overall depression burden and associated health care costs in case of given effectiveness.
","[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Braun', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, Germany. lina.braun@uni-ulm.de.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Titzler', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander-University of Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'David Daniel', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander-University of Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Buntrock', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander-University of Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Yannik', 'Initials': 'Y', 'LastName': 'Terhorst', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Freund', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander-University of Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Janika', 'Initials': 'J', 'LastName': 'Thielecke', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander-University of Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, Germany.'}]",BMC psychiatry,['10.1186/s12888-019-2244-y']
501,30911113,"Short telomeres are associated with inferior outcome, genomic complexity, and clonal evolution in chronic lymphocytic leukemia.","Telomere length in chronic lymphocytic leukemia (CLL) has been shown to be of prognostic importance, but the analyses have largely been executed on heterogeneous patient cohorts outside of clinical trials. In the present study, we performed a comprehensive analysis of telomere length associations in the well characterized CLL8 trial (n = 620) of the German CLL study group, with validation in a representative cohort of the CLL4 trial (n = 293). Absolute telomere length was analyzed using quantitative-PCR. Apart from identifying associations of short telomere length with adverse prognostic factors and survival, the study identified cases with 17p- and 11q- associated with TP53 and ATM loss, respectively, to have the shortest telomeres, even when these aberrations were present in small subclones. Thus, telomere shortening may precede acquisition of the high-risk aberrations, contributing to disease evolution. In line with this, telomere shortening was associated with an increase in genomic complexity as well as clonal evolution, highlighting its importance as a biomarker especially in monitoring disease progression in non-high-risk CLL.",2019,"In line with this, telomere shortening was associated with an increase in genomic complexity as well as clonal evolution, highlighting its importance as a biomarker especially in monitoring disease progression in non-high-risk CLL.","['well characterized CLL8 trial (n\u2009=\u2009620) of the German CLL study group, with validation in a representative cohort of the CLL4 trial (n\u2009=\u2009293', 'chronic lymphocytic leukemia (CLL', 'chronic lymphocytic leukemia']",[],"['TP53 and ATM loss', 'Absolute telomere length', 'genomic complexity']","[{'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0678214', 'cui_str': 'atmosphere (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0085187'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0887950', 'cui_str': 'Genomics'}]",,0.0234911,"In line with this, telomere shortening was associated with an increase in genomic complexity as well as clonal evolution, highlighting its importance as a biomarker especially in monitoring disease progression in non-high-risk CLL.","[{'ForeName': 'Billy Michael Chelliah', 'Initials': 'BMC', 'LastName': 'Jebaraj', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Tausch', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Dan A', 'Initials': 'DA', 'LastName': 'Landau', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Bahlo', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Robrecht', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Amaro N', 'Initials': 'AN', 'LastName': 'Taylor-Weiner', 'Affiliation': 'Broad Institute, Cambridge, MA, USA.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Bloehdorn', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Scheffold', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Mertens', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Böttcher', 'Affiliation': 'Department II of Internal Medicine, University Hospital of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kneba', 'Affiliation': 'Department II of Internal Medicine, University Hospital of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Jäger', 'Affiliation': 'Department of Medicine I, Division of Hematology and Hemostaeology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Zenz', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Wenger', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Guenter', 'Initials': 'G', 'LastName': 'Fingerle-Rowson', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Wendtner', 'Affiliation': 'Klinikum Schwabing, Academic Teaching Hospital of University of Munich, Munich, Germany.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Fink', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Wu', 'Affiliation': 'Broad Institute, Cambridge, MA, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichhorst', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany. stephan.stilgenbauer@uniklinik-ulm.de.'}]",Leukemia,['10.1038/s41375-019-0446-4']
502,31126825,One-year follow-up of a remotely delivered epilepsy self-management program in high-risk people with epilepsy.,"OBJECTIVE


""Self-management for people with epilepsy and a history of negative health events"" (SMART) is a novel group-format epilepsy self-management intervention demonstrated to reduce negative health events (NHEs) such as accidents, emergency department visits, and seizures in adults with epilepsy in a 6-month prospective randomized controlled trial (RCT); SMART also reduced depressive symptoms and improved health functioning and quality of life. This report describes the longer-term (12-month) post-efficacy RCT outcomes in adults with epilepsy who received SMART.
METHODS


After completing a 6-month, prospective RCT that demonstrated efficacy of SMART vs 6-month waitlist control (WL), adults ≥18 years of age with epilepsy were followed for an additional 12 months. Individuals originally randomized to WL received the 8-week SMART intervention immediately following the conclusion of the RCT. For this long-term extension analysis, assessments were conducted at 24 weeks (the 6-month primary outcome time-point of the efficacy RCT), at 32 weeks for individuals originally randomized to WL, and at 48 weeks and 72 weeks for all individuals. Outcomes assessed included past 6-month NHE counts, depressive symptoms assessed with the 9-item Patient Health Questionnaire (PHQ-9) and Montgomery-Asberg Depression Rating Scale (MADRS), and quality of life assessed with the 10-item Quality of Life in Epilepsy (QOLIE-10).
RESULTS


At the beginning of this long-term observational period (24-week follow-up time point for the original RCT), there were 50 individuals in the group originally randomized to SMART and 52 originally randomized to WL. Mean age was 41.4 years, 70% women (N = 71), 64% (N = 65) African-American, and 8% Hispanic (N = 8). Study attrition from week 24 to week 72 was 8% in the arm originally randomized to SMART and 17% in the arm originally randomized to WL. During the 12-month observation period (24 weeks to 72 weeks), there were a total of 44 serious adverse events and 4 deaths, none related to study participation. There was no significant change in total past 6-month NHE counts in the group originally randomized to SMART, although the group had significantly reduced 6-month seizure counts. The group originally randomized to WL, who received SMART during this observational period, had a reduction in total NHE counts. The group originally randomized to SMART had relatively stable levels on other outcome variables except for a trend for improved MADRS (p = 0.08). In the group originally randomized to WL, there were significant improvements in PHQ-9 (p = 0.01), MADRS (p ≤ 0.01), and QOLIE-10 (p = 0.004).
CONCLUSIONS


This post-RCT extension study suggests that adults with epilepsy who participate in the SMART intervention sustain clinical effects at 1-year follow-up and may have incremental improvements in seizure frequency and mood. Future research needs to identify opportunities for scale-up and outreach to other high-risk groups with epilepsy.",2019,"In the group originally randomized to WL, there were significant improvements in PHQ-9 (p = 0.01), MADRS (p ≤ 0.01), and QOLIE-10 (p = 0.004).
","['adults ≥18\u202fyears of age with epilepsy', 'high-risk people with epilepsy', 'Mean age was 41.4\u202fyears, 70% women (N\u202f=\u202f71), 64% (N\u202f=\u202f65) African-American, and 8% Hispanic (N\u202f=\u202f8', 'people with epilepsy and a history of negative health events"" (SMART', 'adults with epilepsy who participate in the', 'adults with epilepsy']","['SMART intervention', 'epilepsy self-management program']","['health functioning and quality of life', 'PHQ-9', 'QOLIE-10', 'total NHE counts', 'past 6-month NHE counts, depressive symptoms assessed with the 9-item Patient Health Questionnaire (PHQ-9) and Montgomery-Asberg Depression Rating Scale (MADRS), and quality of life assessed with the 10-item Quality of Life in Epilepsy (QOLIE-10', '6-month seizure counts', 'MADRS', 'total past 6-month NHE counts']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]","[{'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034380'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}]",,0.104302,"In the group originally randomized to WL, there were significant improvements in PHQ-9 (p = 0.01), MADRS (p ≤ 0.01), and QOLIE-10 (p = 0.004).
","[{'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Sajatovic', 'Affiliation': 'Department of Neurology, Neurological & Behavioral Outcomes Center, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA; Department of Psychiatry, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA. Electronic address: martha.sajatovic@uhhospitals.org.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Colon-Zimmermann', 'Affiliation': 'Department of Neurology, Neurological & Behavioral Outcomes Center, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA; Department of Psychiatry, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Kahriman', 'Affiliation': 'Department of Neurology, Louis Stokes Cleveland VAMC, Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Edna', 'Initials': 'E', 'LastName': 'Fuentes-Casiano', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Burant', 'Affiliation': 'Case Western Reserve University School of Nursing, Louis Stokes Cleveland VAMC, Cleveland, OH, USA.'}, {'ForeName': 'Michelle E', 'Initials': 'ME', 'LastName': 'Aebi', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Cassidy', 'Affiliation': 'Department of Neurology, Neurological & Behavioral Outcomes Center, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA; Department of Psychiatry, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Samden', 'Initials': 'S', 'LastName': 'Lhatoo', 'Affiliation': 'Department of Neurology, University of Texas Houston, Houston, TX, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Einstadter', 'Affiliation': 'Case Western Reserve University and Center for Health Care Research and Policy, MetroHealth Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Peijun', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Louis Stokes Cleveland VAMC, Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2019.04.034']
503,32266599,Assessment of Vancomycin Pharmacokinetics and Dose Regimen Optimisation in Preterm Neonates.,"BACKGROUND


The pharmacokinetics of vancomycin, a drug used for the treatment of methicillin-resistant Staphylococcus aureus (MRSA), varies between paediatric and adult patients.
OBJECTIVE


The objective of this study was to assess the pharmacokinetics of vancomycin in preterm neonates and determine the optimum dose regimen.
METHODS


This was a randomised double-blind study of preterm neonates admitted to neonatal intensive care units. They all received vancomycin 15 mg/kg every 12 h. Blood was sampled just before administration of the third, sixth and ninth vancomycin dose. Pharmacokinetic parameters were estimated using a Bayesian approach implemented in Monolix 2018R2 software. Covariates assessed included postmenstrual age, current weight, creatinine clearance, albumin, gestational age, body surface area and current age. We used Monte Carlo simulations for dose regimen optimisation targeting area under the concentration-time curve up to 24 h (AUC 0-24h ) of ≥ 400 mg × h/L.
RESULTS


In total, 19 preterm neonates were enrolled in the study with a median age of 14 (3-58) days. A one-compartment model with linear elimination best described the pharmacokinetics of vancomycin. Volume of distribution and clearance was 0.88 L and 0.1 L/h, respectively, for a typical neonate weighing 1.48 kg. Simulation of the current dose regimen showed that 27.5% of the neonates would achieve the target AUC 0-24h  of ≥ 400 mg × h/L, and 70.7% of the neonates would achieve it with 12 mg/kg every 8 h.
CONCLUSION


The majority of the neonates were under dosed. Vancomycin 12 mg/kg should be administered every 8 h over 1 h infusion to improve the likelihood of achieving the AUC 0-24h  target of ≥ 400 mg × h/L. This target is considered optimal for MRSA infections, where the vancomycin minimum inhibitory concentration is ≤ 1 µg/mL.",2020,We used Monte Carlo simulations for dose regimen optimisation targeting area under the concentration-time curve up to 24 h (AUC 0-24h ) of ≥ ,"['methicillin-resistant Staphylococcus aureus (MRSA), varies between paediatric and adult patients', 'Preterm Neonates', '19 preterm neonates were enrolled in the study with a median age of 14 (3-58) days', 'preterm neonates', 'preterm neonates admitted to neonatal intensive care units']","['vancomycin', '400\xa0mg\u2009×', 'Vancomycin Pharmacokinetics', 'Vancomycin']","['postmenstrual age, current weight, creatinine clearance, albumin, gestational age, body surface area and current age', 'Volume of distribution and clearance']","[{'cui': 'C0343401', 'cui_str': 'Methicillin resistant Staphylococcus aureus infection'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}]","[{'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",19.0,0.267709,We used Monte Carlo simulations for dose regimen optimisation targeting area under the concentration-time curve up to 24 h (AUC 0-24h ) of ≥ ,"[{'ForeName': 'Mwila', 'Initials': 'M', 'LastName': 'Mulubwa', 'Affiliation': 'School of Pharmacy, University of the Western Cape, Private Bag X17, Bellville, Cape Town, 7535, South Africa. 3579753@myuwc.ac.za.'}, {'ForeName': 'Heletje Aletta', 'Initials': 'HA', 'LastName': 'Griesel', 'Affiliation': 'School of Pharmacy, University of the Western Cape, Private Bag X17, Bellville, Cape Town, 7535, South Africa.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Mugabo', 'Affiliation': 'School of Pharmacy, University of the Western Cape, Private Bag X17, Bellville, Cape Town, 7535, South Africa.'}, {'ForeName': 'Ricky', 'Initials': 'R', 'LastName': 'Dippenaar', 'Affiliation': 'Neonatology Department, Netcare Blaauwberg Hospital, Sunningdale, Cape Town, 7441, South Africa.'}, {'ForeName': 'Lizelle', 'Initials': 'L', 'LastName': 'van Wyk', 'Affiliation': 'Division of Neonatology, Department of Paediatrics and Child Health, Tygerberg Hospital, Stellenbosch University, Cape Town, 7505, South Africa.'}]",Drugs in R&D,['10.1007/s40268-020-00302-7']
504,30816331,"Treatment of higher risk acute lymphoblastic leukemia in young people (CCG-1961), long-term follow-up: a report from the Children's Oncology Group.","Children's Cancer Group CCG-1882 improved outcome for 1-21-year old with high risk acute lymphoblastic leukemia and Induction Day 8 marrow blasts ≥25% (slow early responders, SER) with longer and stronger post induction intensification (PII). This CCG-1961 explored alternative PII strategies. We report 10-year follow-up for patients with rapid early response (RER) and for the first time details our experience for SER patients. A total of 2057 patients were enrolled, and 1299 RER patients were randomized to 1 of 4 PII regimens: standard vs. augmented intensity and standard vs. increased length. At the end of interim maintenance, 447 SER patients were randomized to idarubicin/cyclophosphamide or weekly doxorubicin in the delayed intensification phases. The 10-year EFS for RER were 79.4 ± 2.4% and 70.9 ± 2.6% (hazard ratio = 0.65, 95% CI 0.52-0.82, p < 0.001) for augmented and standard strength PII; the 10-year OS rates were 87.2 ± 2.0% and 81.0 ± 2.2% (hazard ratio = 0.64, 95% CI 0.48-0.86, p = 0.003). Outcomes remain similar for standard and longer PII, and for SER patients assigned to idarubicin/cyclophosphamide and weekly doxorubicin. The EFS and OS advantage of augmented PII is sustained at 10 years for RER patients. Longer PII for RER patients and sequential idarubicin/cyclophosphamide for SER patients offered no advantage. CCG-1961 is the platform for subsequent COG studies.",2019,"Outcomes remain similar for standard and longer PII, and for SER patients assigned to idarubicin/cyclophosphamide and weekly doxorubicin.","['patients with rapid early response (RER) and for the first time\xa0details our experience for SER patients', '447 SER patients', '2057 patients were enrolled, and 1299 RER patients']","['idarubicin/cyclophosphamide and weekly doxorubicin', 'idarubicin/cyclophosphamide or weekly doxorubicin', 'idarubicin/cyclophosphamide', 'CCG-1961']","['10-year OS rates', '10-year EFS for RER']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]","[{'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",2057.0,0.0559644,"Outcomes remain similar for standard and longer PII, and for SER patients assigned to idarubicin/cyclophosphamide and weekly doxorubicin.","[{'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Steinherz', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA. steinhep@mskcc.org.'}, {'ForeName': 'Nita L', 'Initials': 'NL', 'LastName': 'Seibel', 'Affiliation': ""Children's National Health System, George Washington University School of Medicine and Health Sciences, Washington, DC, USA.""}, {'ForeName': 'Harland', 'Initials': 'H', 'LastName': 'Sather', 'Affiliation': ""Children's Oncology Group, Los Angeles, CA, USA.""}, {'ForeName': 'Lingyun', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Children's Oncology Group, Los Angeles, CA, USA.""}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Gaynon', 'Affiliation': ""Children's Hospital of Los Angeles, Los Angeles, CA, USA.""}]",Leukemia,['10.1038/s41375-019-0422-z']
505,32251792,The Efficacy and Safety of High-dose Daptomycin in the Treatment of Complicated Skin and Soft Tissue Infections in Asians.,"OBJECTIVE


To compare the efficacy and safety of standard-dose (SD) daptomycin with those of high-dose (HD) daptomycin in complicated skin and soft tissue infections (cSSTIs) in an Asian population.
MATERIALS AND METHODS


Patients from three medical centers diagnosed with cSSTIs were screened in the clinical information system. Patients included in the analysis were divided into two groups: those who received daptomycin at doses ≥ 6 mg/kg (HD group) and those receiving 4 mg/kg (SD group). The demographics and clinical treatment information were analyzed.
RESULTS


Overall, 155 patients were recruited, including 108 patients in the SD group and 47 patients in the HD group. The rate of healthcare-associated infections was higher in the HD group (61.70% vs. 37.04%), demonstrating a statistically significant difference (P = 0.005). Compared with the SD group, the HD group had statistically significant early clinical stabilization (72.34% vs 52.78%, P = 0.023). The results of the multivariate analysis indicated that HD daptomycin was an independent effector for early clinical stabilization (HR=0.394, P < 0.001). The rate of drug-related adverse events was equally distributed in the HD and SD groups (36.17% vs. 26.85%, P = 0.243).
CONCLUSION


Compared with SD daptomycin, HD daptomycin increased the rate of early clinical stabilization in Asian patients with cSSTIs, whereas the incidence of adverse events did not increase.",2020,"The rate of healthcare-associated infections was higher in the HD group (61.70% vs. 37.04%), demonstrating a statistically significant difference (P = 0.005).","['complicated skin and soft tissue infections (cSSTIs) in an Asian population', '155 patients were recruited, including 108 patients in the SD group and 47 patients in the HD group', 'Patients from three medical centers diagnosed with cSSTIs were screened in the clinical information system', 'Complicated Skin and Soft Tissue Infections in Asians']","['daptomycin at doses ≥ 6\u2009mg/kg (HD group) and those receiving 4\u2009mg/kg (SD group', 'High-dose Daptomycin', 'standard-dose (SD) daptomycin with those of high-dose (HD) daptomycin']","['clinical stabilization', 'rate of early clinical stabilization', 'incidence of adverse events', 'rate of drug-related adverse events', 'rate of healthcare-associated infections', 'efficacy and safety']","[{'cui': 'C4727978', 'cui_str': 'Complicated skin and soft tissue infection'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021428', 'cui_str': 'Information system'}]","[{'cui': 'C0057144', 'cui_str': 'Daptomycin'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",155.0,0.0449794,"The rate of healthcare-associated infections was higher in the HD group (61.70% vs. 37.04%), demonstrating a statistically significant difference (P = 0.005).","[{'ForeName': 'Xiao-Meng', 'Initials': 'XM', 'LastName': 'Dong', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Nan-Nan', 'Initials': 'NN', 'LastName': 'Xu', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Yong-Yuan', 'Initials': 'YY', 'LastName': 'Yao', 'Affiliation': ""Department of Intensive Care Medicine, Rizhao People's Hospital, Rizhao 276800, China.""}, {'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Guan', 'Affiliation': ""Department of Infectious Diseases, Rizhao People's Hospital, Rizhao 276800, China.""}, {'ForeName': 'Qing-Yan', 'Initials': 'QY', 'LastName': 'Li', 'Affiliation': ""Department of Infectious Diseases, Liaocheng People's Hospital, Liaocheng 252000, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zheng', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Feng-Zhe', 'Initials': 'FZ', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China. Electronic address: clinicalpaper@163.com.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.03.060']
506,32406384,"Effect of bilateral needling at an acupuncture point, ST-36 (Zusanli) on blood glucose levels in type 2 diabetes mellitus patients: A pilot randomized placebo controlled trial.","Background Diabetes mellitus is one of the major current public health problems. Electro-acupuncture at ST-36 showed a significant reduction in plasma glucose levels in diabetic rats. There are lacks of studies reporting its hypoglycemic effect in humans and thus, the present study was conducted to evaluate the effect of needling at ST-36 (Zusanli) on blood glucose levels in patients with type 2 diabetes mellitus (T2DM). Methods Sixty T2DM participants were recruited and randomized into acupuncture group (n=30) and placebo control group (n=30). The participants of the acupuncture group received needling at ST-36 (one finger breadth lateral to the inferior border of the tibial tuberosity), and the participants those in the placebo control group received needling at placebo point (midpoint between the apex of the patella and tibial tuberosity). For both the groups, needles were retained for 30 min. Baseline and post-test assessments were performed prior to and after each intervention. Statistical analysis was performed using SPSS version 16. Results The present study showed a significant reduction in random blood glucose levels in the acupuncture group compared to the placebo control group. Conclusion This study suggests that 30 min of bilateral acupuncture needling at ST-36 with manual stimulation is effective in reducing blood glucose levels in T2DM patients.",2020,Electro-acupuncture at ST-36 showed a significant reduction in plasma glucose levels in diabetic rats.,"['group (n=30', 'patients with type 2 diabetes mellitus (T2DM', 'type 2 diabetes mellitus patients', 'Methods Sixty T2DM participants', 'diabetic rats', 'T2DM patients']","['acupuncture', 'placebo control group received needling at placebo', 'needling at ST-36 (Zusanli', 'needling at ST-36', 'bilateral acupuncture needling at ST-36 with manual stimulation', 'placebo control', 'bilateral needling at an acupuncture point, ST-36 (Zusanli', 'placebo']","['blood glucose levels', 'random blood glucose levels', 'plasma glucose levels']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0181956', 'cui_str': 'Acupuncture needle'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0428567', 'cui_str': 'Random blood glucose measurement'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",60.0,0.160234,Electro-acupuncture at ST-36 showed a significant reduction in plasma glucose levels in diabetic rats.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mooventhan', 'Affiliation': 'Department of Research and Development, Government Yoga and Naturopathy Medical College, Arumbakkam, Chennai-600106, India.'}, {'ForeName': 'Reema', 'Initials': 'R', 'LastName': 'Ningombam', 'Affiliation': 'Division of Yoga and Life Sciences, The School of Yoga and Naturopathic Medicine, S-VYASA (Deemed to be University), Bengaluru, India.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Nivethitha', 'Affiliation': 'Department of Naturopathy, Government Yoga and Naturopathy Medical College, Arumbakkam, Chennai-600106, India.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2019-0100']
507,32027763,"From ""4Rs and 2Ss"" to ""Amaka Amasanyufu"" (Happy Families): Adapting a U.S.-based Evidence-Based Intervention to the Uganda Context.","In Uganda, one in five children presents mental health challenges, including disruptive behavior disorders (DBDs). DBDs can persist through adulthood and result in negative outcomes. Effective interventions for DBDs have been developed and tested in high-poverty communities in developed countries. Yet, most African countries, such as Uganda, lack such interventions. This paper describes the adaptation process of an evidence-based intervention of U.S. origin to optimize fit to context with intervention fidelity, as part of a randomized trial conducted with youth that exhibit behavioral challenges and their caregivers in 30 schools in Uganda. The process involved: initial meetings with headteachers and teachers to introduce the study and the main concepts of the intervention; initial manual review focusing on 4Rs and 2Ss content by the Uganda team; engagement of community stakeholders for additional feedback on content and cultural relevance; final revision of the manual; and collection of children's drawings for the illustration of the manual. This paper describes both similarities and differences between the original and adapted intervention content and methods of delivery. The findings also highlight the importance of involving community stakeholders in the adaptation process.",2020,"This paper describes the adaptation process of an evidence-based intervention of U.S. origin to optimize fit to context with intervention fidelity, as part of a randomized trial conducted with youth that exhibit behavioral challenges and their caregivers in 30 schools in Uganda.",['youth that exhibit behavioral challenges and their caregivers in 30 schools in Uganda'],[],[],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}]",[],[],,0.0200189,"This paper describes the adaptation process of an evidence-based intervention of U.S. origin to optimize fit to context with intervention fidelity, as part of a randomized trial conducted with youth that exhibit behavioral challenges and their caregivers in 30 schools in Uganda.","[{'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Sensoy Bahar', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Byansi', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Apollo', 'Initials': 'A', 'LastName': 'Kivumbi', 'Affiliation': 'International Center for Child Health and Development, Uganda Field Office, Masaka, Uganda.'}, {'ForeName': 'Phionah', 'Initials': 'P', 'LastName': 'Namatovu', 'Affiliation': 'International Center for Child Health and Development, Uganda Field Office, Masaka, Uganda.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Kiyingi', 'Affiliation': 'International Center for Child Health and Development, Uganda Field Office, Masaka, Uganda.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McKay', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Thabani', 'Initials': 'T', 'LastName': 'Nyoni', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, MO.'}]",Family process,['10.1111/famp.12525']
508,31070709,"A phase III, randomized, open-label study of ASP8273 versus erlotinib or gefitinib in patients with advanced stage IIIB/IV non-small-cell lung cancer.","BACKGROUND


ASP8273, a novel, small molecule, irreversible tyrosine kinase inhibitor (TKI) specifically inhibits the epidermal growth factor receptor (EGFR) in patients with activating mutations or EGFR T790M resistance mutations. The current study examines the efficacy, safety, and tolerability of ASP8273 versus erlotinib or gefitinib in patients with non-small-cell lung cancer (NSCLC) with activating EGFR mutations not previously treated with an EGFR inhibitor.
PATIENTS AND METHODS


This global, phase III, open-label, randomized study evaluated ASP8273 versus erlotinib/gefitinib in patients with locally advanced, metastatic, or unresectable stage IIIB/IV NSCLC with activating EGFR mutations. They were ineligible if they received prior chemotherapy for metastatic disease. The primary end point was progression-free survival (PFS), and secondary end points included overall survival, investigator-assessed PFS, best overall response rate (ORR), disease control rate, duration of response (DoR), and the safety/tolerability profile.
RESULTS


Patients (n = 530) were randomized 1 : 1 to receive ASP8273 (n = 267) or erlotinib/gefitinib (n = 263). Patient demographics between both treatment groups were generally balanced. Median PFS was 9.3 months (95% CI 5.6-11.1 months) for patients receiving ASP8273 and 9.6 months (95% CI 8.8-NE) for the erlotinib/gefitinib group, with a hazard ratio of 1.611 (P = 0.992). The ORR in the ASP8273 group was 33% (95% CI 27.4-39.0) versus 47.9% (95% CI 41.7-54.1) in the erlotinib/gefitinib group. Median DoR was similar for both groups (9.2 months for ASP8273 versus 9.0 months for erlotinib/gefitinib). More grade ≥3 treatment-emergent adverse events (TEAEs) occurred in patients receiving ASP8273 than in those receiving erlotinib/gefitinib (54.7% versus 43.5%). An independent data monitoring committee carried out an interim safety analysis and recommended discontinuing the study due to toxicity and limited predicted efficacy of ASP8273 relative to erlotinib/gefitinib.
CONCLUSIONS


First-line ASP8273 did not show improved PFS or equivalent toxicities versus erlotinib/gefitinib.
CLINICALTRIAL.GOV NUMBER


NCT02588261.",2019,"Median PFS was 9.3 months (95% CI, 5.6-11.1 months) for patients receiving ASP8273 and 9.6 months (95% CI, 8.8-NE) for the erlotinib/gefitinib group, with a hazard ratio of 1.611 (P=0.992).","['Patients With Advanced Stage IIIB/IV Non-Small Cell Lung Cancer', 'patients with activating mutations or EGFR T790M resistance mutations', 'patients with non-small cell lung cancer (NSCLC) with activating EGFR mutations not previously treated with an EGFR inhibitor', 'Patients (n=530', 'patients with locally advanced, metastatic, or unresectable stage IIIB/IV NSCLC with activating EGFR mutations']","['erlotinib/gefitinib', 'ASP8273 versus erlotinib or gefitinib', 'ASP8273', 'ASP8273 versus erlotinib/gefitinib', 'Erlotinib or Gefitinib']","['progression-free survival (PFS', 'efficacy, safety, and tolerability', 'overall survival, investigator-assessed PFS, best overall response rate (ORR), disease control rate, duration of response (DoR), and the safety/tolerability profile', 'PFS or equivalent toxicities', 'ORR', 'Median DoR', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]","[{'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",530.0,0.0680652,"Median PFS was 9.3 months (95% CI, 5.6-11.1 months) for patients receiving ASP8273 and 9.6 months (95% CI, 8.8-NE) for the erlotinib/gefitinib group, with a hazard ratio of 1.611 (P=0.992).","[{'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Kelly', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore and The Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas, USA. Electronic address: Ronan.Kelly@BSWHealth.org.'}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'Shepherd', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Krivoshik', 'Affiliation': 'Departments of Oncology.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Jie', 'Affiliation': 'Biostatistics, Astellas Pharma US, Inc., Northbrook.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Horn', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz128']
509,31296648,Long-term Weight Loss Maintenance in the Continuation of a Randomized Diabetes Prevention Translational Study: The Healthy Living Partnerships to Prevent Diabetes (HELP PD) Continuation Trial.,"OBJECTIVE


HELP PD was a clinical trial of 301 adults with prediabetes. Participants were randomized to enhanced usual care (EUC) or to a lifestyle weight loss (LWL) intervention led by community health workers that consisted of a 6-month intensive phase (phase 1) and 18 months of maintenance (phase 2). At 24 months, participants were asked to enroll in phase 3 to assess whether continued group maintenance (GM) sessions would maintain improvements realized in phases 1 and 2 compared with self-directed maintenance (SM) or EUC.
RESEARCH DESIGN AND METHODS


In phase 3, LWL participants were randomly assigned to GM or SM. EUC participants remained in the EUC arm and, along with participants in SM, received monthly newsletters. All participants received semiannual dietitian sessions. Anthropometrics and biomarkers were assessed every 6 months. Mixed-effects models were used to assess changes in outcomes over time.
RESULTS


Eighty-two of the 151 intervention participants (54%) agreed to participate in phase 3; 41 were randomized to GM and 41 to SM. Of the 150 EUC participants, 107 (71%) continued. Ninety percent of clinic visits were completed. Over 48 months of additional follow-up, outcomes remained relatively stable in the EUC participants; the GM group was able to maintain body weight, BMI, and waist circumference; and these measures all increased significantly ( P  < 0.001) in the SM group.
CONCLUSIONS


Participants in the GM arm maintained weight loss achieved in phases 1 and 2, while those in the SM arm regained weight. Because group session attendance by the participants in the GM arm was low, it is unclear what intervention components led to successful weight maintenance.",2019,"Over 48 months of additional follow-up, outcomes remained relatively stable in the EUC participants; the GM group was able to maintain body weight, BMI, and waist circumference; and these measures all increased significantly ( P  < 0.001) in the SM group.
","['301 adults with prediabetes', 'Eighty-two of the 151 intervention participants (54%) agreed to participate in phase 3; 41']","['enhanced usual care (EUC) or to a lifestyle weight loss (LWL) intervention led by community health workers that consisted of a 6-month intensive phase', 'GM or SM', 'continued group maintenance (GM) sessions would maintain improvements realized in phases 1 and 2 compared with self-directed maintenance (SM) or EUC', 'semiannual dietitian sessions', 'Long-term Weight Loss Maintenance']","['maintain body weight, BMI, and waist circumference', 'maintained weight loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general) (occupation)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",301.0,0.0801487,"Over 48 months of additional follow-up, outcomes remained relatively stable in the EUC participants; the GM group was able to maintain body weight, BMI, and waist circumference; and these measures all increased significantly ( P  < 0.001) in the SM group.
","[{'ForeName': 'Mara Z', 'Initials': 'MZ', 'LastName': 'Vitolins', 'Affiliation': 'Department of Epidemiology and Prevention, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC mvitolin@wakehealth.edu.'}, {'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Blackwell', 'Affiliation': 'Department of Epidemiology and Prevention, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Katula', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'Scott P', 'Initials': 'SP', 'LastName': 'Isom', 'Affiliation': 'Department of Biostatistics and Data Sciences, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'L Douglas', 'Initials': 'LD', 'LastName': 'Case', 'Affiliation': 'Department of Biostatistics and Data Sciences, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC.'}]",Diabetes care,['10.2337/dc19-0295']
510,30937431,Prolonged lung cancer screening reduced 10-year mortality in the MILD trial: new confirmation of lung cancer screening efficacy.,"BACKGROUND


The National Lung Screening Trial showed that lung cancer (LC) screening by three annual rounds of low-dose computed tomography (LDCT) reduces LC mortality. We evaluated the benefit of prolonged LDCT screening beyond 5 years, and its impact on overall and LC specific mortality at 10 years.
DESIGN


The Multicentric Italian Lung Detection (MILD) trial prospectively randomized 4099 participants, to a screening arm (n = 2376), with further randomization to annual (n = 1190) or biennial (n = 1186) LDCT for a median period of 6 years, or control arm (n = 1723) without intervention. Between 2005 and 2018, 39 293 person-years of follow-up were accumulated. The primary outcomes were 10-year overall and LC specific mortality. Landmark analysis was used to test the long-term effect of LC screening, beyond 5 years by exclusion of LCs and deaths that occurred in the first 5 years.
RESULTS


The LDCT arm showed a 39% reduced risk of LC mortality at 10 years [hazard ratio (HR) 0.61; 95% confidence interval (CI) 0.39-0.95], compared with control arm, and a 20% reduction of overall mortality (HR 0.80; 95% CI 0.62-1.03). LDCT benefit improved beyond the 5th year of screening, with a 58% reduced risk of LC mortality (HR 0.42; 95% CI 0.22-0.79), and 32% reduction of overall mortality (HR 0.68; 95% CI 0.49-0.94).
CONCLUSIONS


The MILD trial provides additional evidence that prolonged screening beyond 5 years can enhance the benefit of early detection and achieve a greater overall and LC mortality reduction compared with NLST trial.
CLINICALTRIALS.GOV IDENTIFIER


NCT02837809.",2019,"The LDCT arm showed a 39% reduced risk of LC mortality at 10 years (HR 0.61, 95%CI 0.39-0.95), compared with control arm, and a 20% reduction of overall mortality (HR: 0.80, 95%CI 0.62-1.03).","['Between 2005 and 2018, 39,293 person-years of follow-up were accumulated', 'The Multicentric Italian Lung Detection (MILD) trial prospectively randomized 4,099 participants, to a screening arm (n\u2009=\u20092,376), with further randomization to annual (n\u2009=\u20091190) or biennial (n\u2009=\u20091186']","['low-dose computed tomography (LDCT', 'LDCT']","['risk of LC mortality', 'lung cancer mortality', 'overall mortality', '10-year Mortality', 'LDCT benefit', '10-year overall and LC specific mortality', 'overall and LC specific mortality']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439743', 'cui_str': 'Multicentric (qualifier value)'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",4099.0,0.364185,"The LDCT arm showed a 39% reduced risk of LC mortality at 10 years (HR 0.61, 95%CI 0.39-0.95), compared with control arm, and a 20% reduction of overall mortality (HR: 0.80, 95%CI 0.62-1.03).","[{'ForeName': 'U', 'Initials': 'U', 'LastName': 'Pastorino', 'Affiliation': 'Unit of Thoracic Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan. Electronic address: ugo.pastorino@istitutotumori.mi.it.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Silva', 'Affiliation': 'Unit of Thoracic Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan; Section of Radiology, Unit of Surgical Sciences, Department of Medicine and Surgery (DiMeC), University of Parma, Parma.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sestini', 'Affiliation': 'Unit of Thoracic Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Sabia', 'Affiliation': 'Unit of Thoracic Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boeri', 'Affiliation': 'Tumour Genomics Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cantarutti', 'Affiliation': 'Division of Biostatistics, Department of Statistics and Quantitative Methods, Epidemiology and Public Health, University of Milano-Bicocca, Milan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Sverzellati', 'Affiliation': 'Section of Radiology, Unit of Surgical Sciences, Department of Medicine and Surgery (DiMeC), University of Parma, Parma.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sozzi', 'Affiliation': 'Tumour Genomics Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Corrao', 'Affiliation': 'Division of Biostatistics, Department of Statistics and Quantitative Methods, Epidemiology and Public Health, University of Milano-Bicocca, Milan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Marchianò', 'Affiliation': 'Department of Radiology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz117']
511,31020334,Prognostic value of circulating tumour cells in limited-stage small-cell lung cancer: analysis of the concurrent once-daily versus twice-daily radiotherapy (CONVERT) randomised controlled trial.,"BACKGROUND


The clinical significance of circulating tumour cells (CTCs) in limited-stage small-cell lung cancer (LS-SCLC) is not well defined. We report a planned exploratory analysis of the prevalence and prognostic value of CTCs in LS-SCLC patients enrolled within the phase III randomised CONVERT (concurrent once-daily versus twice-daily chemoradiotherapy) trial.
PATIENTS AND METHODS


Baseline blood samples were enumerated for CTCs using CellSearch in 75 patients with LS-SCLC who were enrolled in the CONVERT trial and randomised between twice- and once-daily concurrent chemoradiation. Standard statistical methods were used for correlations of CTCs with clinical factors. Log-rank test and Cox regression analyses were applied to establish the associations of 2, 15 and 50 CTC thresholds with progression-free survival (PFS) and overall survival (OS). An optimal CTC count threshold for LS-SCLC was established.
RESULTS


CTCs were detected in 60% (45/75) of patients (range 0-3750). CTC count thresholds of 2, 15 and 50 CTCs all significantly correlate with PFS and OS. An optimal CTC count threshold in LS-SCLC was established at 15 CTCs, defining 'favourable' and 'unfavourable' prognostic risk groups. The median OS in <15 versus ≥15 CTCs was 26.7 versus 5.9 m (P = 0.001). The presence of ≥15 CTCs at baseline independently predicted ≤1 year survival in 70% and ≤2 years survival in 100% of patients.
CONCLUSION


We report the prognostic value of baseline CTC count in an exclusive LS-SCLC population at thresholds of 2, 15 and 50 CTCs. Specific to LS-SCLC, ≥15 CTCs was associated with worse PFS and OS independent of all other factors and predicted ≤2 years survival. These results may improve disease stratification in future clinical trial designs and aid clinical decision making.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT00433563.",2019,"The presence of ≥ 15 CTCs at baseline independently predicted ≤1 year survival in 70% and ≤2 years survival in 100% of patients.
","['Baseline blood samples were enumerated for CTCs using CellSearch in 75 patients with LS-SCLC who were enrolled in the CONVERT trial and randomised between', 'limited-stage small cell lung cancer', 'LS-SCLC patients enrolled within the phase 3 randomised CONVERT trial']",['twice- and once-daily concurrent chemoradiation'],"['progression-free (PFS) and overall survival (OS', 'PFS and OS', 'CTC count thresholds', 'median OS']","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}]","[{'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",75.0,0.168964,"The presence of ≥ 15 CTCs at baseline independently predicted ≤1 year survival in 70% and ≤2 years survival in 100% of patients.
","[{'ForeName': 'R Y', 'Initials': 'RY', 'LastName': 'Tay', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Fernández-Gutiérrez', 'Affiliation': 'Clinical and Experimental Pharmacology Group, CRUK Manchester Institute.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Foy', 'Affiliation': 'Clinical and Experimental Pharmacology Group, CRUK Manchester Institute.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Burns', 'Affiliation': 'Division of Molecular and Clinical Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pierce', 'Affiliation': 'Clinical and Experimental Pharmacology Group, CRUK Manchester Institute.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Morris', 'Affiliation': 'Clinical and Experimental Pharmacology Group, CRUK Manchester Institute.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Priest', 'Affiliation': 'Clinical and Experimental Pharmacology Group, CRUK Manchester Institute.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tugwood', 'Affiliation': 'Cancer Research UK Manchester Institute; Manchester Centre for Cancer Biomarker Sciences, University of Manchester, Manchester.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ashcroft', 'Affiliation': 'Manchester Academic Health Science Centre Trials Co-ordination Unit.'}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Lindsay', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester; Division of Molecular and Clinical Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Faivre-Finn', 'Affiliation': 'Division of Molecular and Clinical Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health; Department of Radiotherapy Related Research, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dive', 'Affiliation': 'Cancer Research UK Manchester Institute; Manchester Centre for Cancer Biomarker Sciences, University of Manchester, Manchester.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Blackhall', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester; Division of Molecular and Clinical Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health. Electronic address: fiona.blackhall@christie.nhs.uk.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz122']
512,31560068,Addition of docetaxel to hormonal therapy in low- and high-burden metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDE trial.,"BACKGROUND


STAMPEDE has previously reported that the use of upfront docetaxel improved overall survival (OS) for metastatic hormone naïve prostate cancer patients starting long-term androgen deprivation therapy. We report on long-term outcomes stratified by metastatic burden for M1 patients.
METHODS


We randomly allocated patients in 2 : 1 ratio to standard-of-care (SOC; control group) or SOC + docetaxel. Metastatic disease burden was categorised using retrospectively-collected baseline staging scans where available. Analysis used Cox regression models, adjusted for stratification factors, with emphasis on restricted mean survival time where hazards were non-proportional.
RESULTS


Between 05 October 2005 and 31 March 2013, 1086 M1 patients were randomised to receive SOC (n = 724) or SOC + docetaxel (n = 362). Metastatic burden was assessable for 830/1086 (76%) patients; 362 (44%) had low and 468 (56%) high metastatic burden. Median follow-up was 78.2 months. There were 494 deaths on SOC (41% more than the previous report). There was good evidence of benefit of docetaxel over SOC on OS (HR = 0.81, 95% CI 0.69-0.95, P = 0.009) with no evidence of heterogeneity of docetaxel effect between metastatic burden sub-groups (interaction P = 0.827). Analysis of other outcomes found evidence of benefit for docetaxel over SOC in failure-free survival (HR = 0.66, 95% CI 0.57-0.76, P < 0.001) and progression-free survival (HR = 0.69, 95% CI 0.59-0.81, P < 0.001) with no evidence of heterogeneity of docetaxel effect between metastatic burden sub-groups (interaction P > 0.5 in each case). There was no evidence that docetaxel resulted in late toxicity compared with SOC: after 1 year, G3-5 toxicity was reported for 28% SOC and 27% docetaxel (in patients still on follow-up at 1 year without prior progression).
CONCLUSIONS


The clinically significant benefit in survival for upfront docetaxel persists at longer follow-up, with no evidence that benefit differed by metastatic burden. We advocate that upfront docetaxel is considered for metastatic hormone naïve prostate cancer patients regardless of metastatic burden.",2019,"There was no evidence that docetaxel resulted in late toxicity compared with SOC: after 1 year, G3-5 toxicity was reported for 28% SOC and 27% docetaxel (in patients still on follow-up at 1 year without prior progression).
","['We randomly allocated patients in 2\u2009', 'Between 05 October 2005 and 31 March 2013, 1086 M1 patients', 'M1 patients', 'low- and high-burden metastatic hormone sensitive prostate cancer', 'metastatic hormone naïve prostate cancer patients regardless of metastatic burden', 'metastatic hormone naïve prostate cancer patients starting long-term androgen deprivation therapy']","['docetaxel', 'SOC', 'SOC\u2009+\u2009docetaxel', '1 ratio to standard-of-care (SOC; control group) or SOC\u2009+\u2009docetaxel', 'upfront docetaxel']","['Metastatic burden', 'survival', 'failure-free survival', 'progression-free survival', 'late toxicity', 'overall survival (OS', 'G3-5 toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",724.0,0.397865,"There was no evidence that docetaxel resulted in late toxicity compared with SOC: after 1 year, G3-5 toxicity was reported for 28% SOC and 27% docetaxel (in patients still on follow-up at 1 year without prior progression).
","[{'ForeName': 'N W', 'Initials': 'NW', 'LastName': 'Clarke', 'Affiliation': 'Department of Urology, The Christie and Salford Royal NHS Foundation Trusts, Manchester. Electronic address: noel.clarke@christie.nhs.uk.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Genito-Urinary Cancer Research Group, Division of Cancer Sciences, The University of Manchester, Manchester.'}, {'ForeName': 'F C', 'Initials': 'FC', 'LastName': 'Ingleby', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London; London School of Hygiene and Tropical Medicine, London.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hoyle', 'Affiliation': 'Department of Urology, The Christie and Salford Royal NHS Foundation Trusts, Manchester.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Amos', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Attard', 'Affiliation': 'UCL Cancer Institute, London.'}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Brawley', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Calvert', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chowdhury', 'Affiliation': ""Guy's and Saint Thomas' NHS Foundation Trust, London.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cook', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Cross', 'Affiliation': 'St James University Hospital, Leeds.'}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Dearnaley', 'Affiliation': 'Institute of Cancer Research, Sutton-London.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Douis', 'Affiliation': 'Department of Radiology, University Hospitals Birmingham NHS Foundation Trust, Birmingham.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Gilbert', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gillessen', 'Affiliation': 'Division of Cancer Sciences, The University of Manchester, Manchester.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Jones', 'Affiliation': 'Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow.'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Langley', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'MacNair', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Malik', 'Affiliation': 'The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Mason', 'Affiliation': 'Cardiff University, Cardiff.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Matheson', 'Affiliation': 'Faculty of Education Health and Wellbeing, University of Wolverhampton, Wolverhampton.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Millman', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London.'}, {'ForeName': 'C C', 'Initials': 'CC', 'LastName': 'Parker', 'Affiliation': 'Institute of Cancer Research, Sutton-London; Royal Marsden NHS Foundation Trust, London.'}, {'ForeName': 'A W S', 'Initials': 'AWS', 'LastName': 'Ritchie', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Rush', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Russell', 'Affiliation': 'Institute of Cancer Sciences, Beatson West of Scotland Cancer Centre, Glasgow.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'University of Sheffield, Sheffield.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Beesley', 'Affiliation': 'Kent Oncology Centre, Maidstone.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Birtle', 'Affiliation': 'Lancashire Teaching Hospitals NHS Foundation Trust, Preston.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Capaldi', 'Affiliation': 'Worcestershire Acute Hospitals NHS Trust, Worcester.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gale', 'Affiliation': 'Portsmouth Oncology Centre, Queen Alexandra Hospital, Portsmouth.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gibbs', 'Affiliation': ""Queen's Hospital, Romford.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lydon', 'Affiliation': 'Torbay and South Devon NHS Foundation Trust, Torbay.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nikapota', 'Affiliation': 'Sussex Cancer Centre, Brighton.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Omlin', 'Affiliation': 'Department of Oncology and Haematology, Kantonsspital, St Gallen, Switzerland.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': ""O'Sullivan"", 'Affiliation': ""Centre for Cancer Research and Cell Biology, Queen's University Belfast, Belfast.""}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Parikh', 'Affiliation': 'East Lancashire Hospitals NHS Trust, Blackburn.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Protheroe', 'Affiliation': 'Oxford University Hospitals NHS Foundation Trust, Oxford.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rudman', 'Affiliation': ""Guy's and Saint Thomas' NHS Foundation Trust, London.""}, {'ForeName': 'N N', 'Initials': 'NN', 'LastName': 'Srihari', 'Affiliation': 'Shrewsbury and Telford Hospital NHS Trust, Shrewsbury.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Simms', 'Affiliation': 'Hull and East Yorkshire Hospitals NHS Trust, Hull.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Tanguay', 'Affiliation': 'Velindre Cancer Centre, Cardiff.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tolan', 'Affiliation': 'The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wagstaff', 'Affiliation': 'Swansea University College of Medicine, Swansea.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wallace', 'Affiliation': 'Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wylie', 'Affiliation': 'The Christie NHS Foundation Trust, Manchester.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zarkar', 'Affiliation': 'Heartlands Hospital, Birmingham.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London.'}, {'ForeName': 'M K B', 'Initials': 'MKB', 'LastName': 'Parmar', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London.'}, {'ForeName': 'N D', 'Initials': 'ND', 'LastName': 'James', 'Affiliation': 'Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz396']
513,31562758,Health-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer receiving maintenance olaparib.,"BACKGROUND


Patients with metastatic pancreatic cancer often have a detriment in health-related quality of life (HRQoL). In the randomized, double-blind, phase III POLO trial progression-free survival was significantly longer with maintenance olaparib, a poly(ADP-ribose) polymerase inhibitor, than placebo in patients with a germline BRCA1 and/or BRCA2 mutation (gBRCAm) and metastatic pancreatic cancer whose disease had not progressed during first-line platinum-based chemotherapy. The prespecified HRQoL evaluation is reported here.
PATIENTS AND METHODS


Patients were randomized to receive maintenance olaparib (300 mg b.i.d.; tablets) or placebo. HRQoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item module at baseline, every 4 weeks until disease progression, at discontinuation, and 30 days after last dose. Scores ranged from 0 to 100; a ≥10-point change or difference between arms was considered clinically meaningful. Adjusted mean change from baseline was analysed using a mixed model for repeated measures. Time to sustained clinically meaningful deterioration (TSCMD) was analysed using a log-rank test.
RESULTS


Of 154 randomized patients, 89 of 92 olaparib-arm and 58 of 62 placebo-arm patients were included in HRQoL analyses. The adjusted mean change in Global Health Status (GHS) score from baseline was <10 points in both arms and there was no significant between-group difference [-2.47; 95% confidence interval (CI) -7.27, 2.33; P = 0.31]. Analysis of physical functioning scores showed a significant between-group difference (-4.45 points; 95% CI -8.75, -0.16; P = 0.04). There was no difference in TSCMD for olaparib versus placebo for GHS [P = 0.25; hazard ratio (HR) 0.72; 95% CI 0.41, 1.27] or physical functioning (P = 0.32; HR 1.38; 95% CI 0.73, 2.63).
CONCLUSIONS


HRQoL was preserved with maintenance olaparib treatment with no clinically meaningful difference compared with placebo. These results support the observed efficacy benefit of maintenance olaparib in patients with a gBRCAm and metastatic pancreatic cancer.
CLINCALTRIALS.GOV NUMBER


NCT02184195.",2019,"The adjusted mean change in Global Health Status (GHS) score from baseline was less than 10 points in both arms and there was no significant between-group difference (-2.47; 95% CI - 7.27, 2.33; P=0.31).","['Patients', 'patients with a gBRCAm and mPC', 'patients with a germline BRCA1 and/or BRCA2 mutation (gBRCAm) and mPC whose disease had not progressed during first-line platinum-based chemotherapy', 'patients with a germline BRCA mutation and metastatic pancreatic cancer receiving maintenance olaparib', 'Of 154 randomized patients, 89 of 92 olaparib-arm and 58 of 62 placebo-arm patients were included in HRQoL analyses', 'Patients with metastatic pancreatic cancer (mPC']","['placebo', 'maintenance olaparib']","['HRQoL', 'physical functioning scores', 'physical functioning', 'Cancer Quality of Life Questionnaire Core 30-item module', 'Global Health Status (GHS) score', 'Health-related quality of life', 'TSCMD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",154.0,0.644628,"The adjusted mean change in Global Health Status (GHS) score from baseline was less than 10 points in both arms and there was no significant between-group difference (-2.47; 95% CI - 7.27, 2.33; P=0.31).","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hammel', 'Affiliation': 'Department of Digestive Oncology, Hôpital Beaujon (AP-HP), Clichy, and University Paris VII, Paris, France. Electronic address: pascal.hammel@aphp.fr.'}, {'ForeName': 'H L', 'Initials': 'HL', 'LastName': 'Kindler', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, University of Chicago, Chicago, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Reni', 'Affiliation': 'Department of Oncology, IRCCS Ospedale San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'Division of Digestive Oncology, University Hospitals Gasthuisberg and KU Leuven, Leuven, Belgium.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Macarulla', 'Affiliation': ""Department of Medical Oncology, Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Hall', 'Affiliation': 'Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, USA.'}, {'ForeName': 'J O', 'Initials': 'JO', 'LastName': 'Park', 'Affiliation': 'Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hochhauser', 'Affiliation': 'Department of Oncology, University College London Cancer Institute, London, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Arnold', 'Affiliation': 'Department of Oncology, Asklepios Tumorzentrum Hamburg Asklepios Klinik Altona, Hamburg, Germany.'}, {'ForeName': 'D-Y', 'Initials': 'DY', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Reinacher-Schick', 'Affiliation': 'Department of Hematology, Oncology and Palliative Care, St. Josef-Hospital, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Tortora', 'Affiliation': 'Department of Medicine, Section of Medical Oncology, Azienda Ospedaliera Universitaria Integrata Verona, Verona and Fondazione Policlinico Universitario Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Algül', 'Affiliation': 'Second Department of Internal Medicine, Klinikum rechts der Isar, Comprehensive Cancer Center Munich-TUM and Department of Internal Medicine II, Technische Universität München, Munich, Germany.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'Gastrointestinal Oncology Service, Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'McGuinness', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'K Y', 'Initials': 'KY', 'LastName': 'Cui', 'Affiliation': 'AstraZeneca, Gaithersburg, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Joo', 'Affiliation': 'Merck & Co., Inc., Kenilworth, USA.'}, {'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Yoo', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'AstraZeneca, Gaithersburg, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Golan', 'Affiliation': 'The Oncology Institute, Sheba Medical Center, Tel Aviv, Israel.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz406']
514,31504126,Breast Cancer Index and prediction of benefit from extended endocrine therapy in breast cancer patients treated in the Adjuvant Tamoxifen-To Offer More? (aTTom) trial.,"BACKGROUND


Extending the duration of adjuvant endocrine therapy reduces the risk of recurrence in a subset of women with early-stage hormone receptor-positive (HR+) breast cancer. Validated predictive biomarkers of endocrine response could significantly improve patient selection for extended therapy. Breast cancer index (BCI) [HOXB13/IL17BR ratio (H/I)] was evaluated for its ability to predict benefit from extended endocrine therapy in patients previously randomized in the Adjuvant Tamoxifen-To Offer More? (aTTom) trial.
PATIENTS AND METHODS


Trans-aTTom is a multi-institutional, prospective-retrospective study in patients with available formalin-fixed paraffin-embedded primary tumor blocks. BCI testing and central determination of estrogen receptor (ER) and progesterone receptor (PR) status by immunohistochemistry were carried out blinded to clinical outcome. Survival endpoints were evaluated using Kaplan-Meier analysis and Cox regression with recurrence-free interval (RFI) as the primary endpoint. Interaction between extended endocrine therapy and BCI (H/I) was assessed using the likelihood ratio test.
RESULTS


Of 583 HR+, N+ patients analyzed, 49% classified as BCI (H/I)-High derived a significant benefit from 10 versus 5 years of tamoxifen treatment [hazard ratio (HR): 0.35; 95% confidence interval (CI) 0.15-0.86; 10.2% absolute risk reduction based on RFI, P = 0.027]. BCI (H/I)-low patients showed no significant benefit from extended endocrine therapy (HR: 1.07; 95% CI 0.69-1.65; -0.2% absolute risk reduction; P = 0.768). Continuous BCI (H/I) levels predicted the magnitude of benefit from extended tamoxifen, whereas centralized ER and PR did not. Interaction between extended tamoxifen treatment and BCI (H/I) was statistically significant (P = 0.012), adjusting for clinicopathological factors.
CONCLUSION


BCI by high H/I expression was predictive of endocrine response and identified a subset of HR+, N+ patients with significant benefit from 10 versus 5 years of tamoxifen therapy. These data provide further validation, consistent with previous MA.17 data, establishing level 1B evidence for BCI as a predictive biomarker of benefit from extended endocrine therapy.
TRIAL REGISTRATION


ISRCTN17222211; NCT00003678.",2019,"Interaction between extended tamoxifen treatment and BCI (H/I) was statistically significant (P = 0.012), adjusting for clinicopathological factors.
","['patients with available formalin-fixed paraffin-embedded (FFPE) primary tumor blocks', 'Breast Cancer Patients Treated in the Adjuvant', 'women with early-stage hormone receptor-positive (HR+) breast cancer']","['tamoxifen therapy', 'adjuvant endocrine therapy', 'Tamoxifen', 'tamoxifen', 'Endocrine Therapy']","['BCI testing and central determination of estrogen receptor (ER) and progesterone receptor (PR) status by immunohistochemistry (IHC', 'Survival endpoints', 'risk of recurrence', 'BCI', 'Breast Cancer Index (BCI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0949307', 'cui_str': 'Formalin'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0085185', 'cui_str': 'Paraffin Embedding'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]","[{'cui': 'C4510392', 'cui_str': 'Tamoxifen therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1148554', 'cui_str': 'determination'}, {'cui': 'C0034804', 'cui_str': 'Estrogen Receptors'}, {'cui': 'C0034833', 'cui_str': 'Receptors, Progestin'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.13255,"Interaction between extended tamoxifen treatment and BCI (H/I) was statistically significant (P = 0.012), adjusting for clinicopathological factors.
","[{'ForeName': 'J M S', 'Initials': 'JMS', 'LastName': 'Bartlett', 'Affiliation': 'Ontario Institute for Cancer Research, Toronto, Canada; University of Edinburgh Cancer Research Centre, Edinburgh, UK. Electronic address: john.bartlett@oicr.on.ca.'}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Sgroi', 'Affiliation': 'Department of Pathology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Treuner', 'Affiliation': 'Biotheranostics Inc., San Diego, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Biotheranostics Inc., San Diego, USA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': 'Cancer Research UK Clinical Trials Unit (CRCTU), Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Piper', 'Affiliation': 'University of Edinburgh Cancer Research Centre, Edinburgh, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Salunga', 'Affiliation': 'Biotheranostics Inc., San Diego, USA.'}, {'ForeName': 'E F', 'Initials': 'EF', 'LastName': 'Brachtel', 'Affiliation': 'Department of Pathology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Pirrie', 'Affiliation': 'Cancer Research UK Clinical Trials Unit (CRCTU), Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Schnabel', 'Affiliation': 'Biotheranostics Inc., San Diego, USA.'}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Rea', 'Affiliation': 'Cancer Research UK Clinical Trials Unit (CRCTU), Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz289']
515,31504118,Myelopreservation with the CDK4/6 inhibitor trilaciclib in patients with small-cell lung cancer receiving first-line chemotherapy: a phase Ib/randomized phase II trial.,"BACKGROUND


Chemotherapy-induced damage of hematopoietic stem and progenitor cells (HSPC) causes multi-lineage myelosuppression. Trilaciclib is an intravenous CDK4/6 inhibitor in development to proactively preserve HSPC and immune system function during chemotherapy (myelopreservation). Preclinically, trilaciclib transiently maintains HSPC in G1 arrest and protects them from chemotherapy damage, leading to faster hematopoietic recovery and enhanced antitumor immunity.
PATIENTS AND METHODS


This was a phase Ib (open-label, dose-finding) and phase II (randomized, double-blind placebo-controlled) study of the safety, efficacy and PK of trilaciclib in combination with etoposide/carboplatin (E/P) therapy for treatment-naive extensive-stage small-cell lung cancer patients. Patients received trilaciclib or placebo before E/P on days 1-3 of each cycle. Select end points were prespecified to assess the effect of trilaciclib on myelosuppression and antitumor efficacy.
RESULTS


A total of 122 patients were enrolled, with 19 patients in part 1 and 75 patients in part 2 receiving study drug. Improvements were seen with trilaciclib in neutrophil, RBC (red blood cell) and lymphocyte measures. Safety on trilaciclib+E/P was improved with fewer ≥G3 adverse events (AEs) in trilaciclib (50%) versus placebo (83.8%), primarily due to less hematological toxicity. No trilaciclib-related ≥G3 AEs occurred. Antitumor efficacy assessment for trilaciclib versus placebo, respectively, showed: ORR (66.7% versus 56.8%, P = 0.3831); median PFS [6.2 versus 5.0 m; hazard ratio (HR) 0.71; P = 0.1695]; and OS (10.9 versus 10.6 m; HR 0.87; P = 0.6107).
CONCLUSION


Trilaciclib demonstrated an improvement in the patient's tolerability of chemotherapy as shown by myelopreservation across multiple hematopoietic lineages resulting in fewer supportive care interventions and dose reductions, improved safety profile, and no detriment to antitumor efficacy. These data demonstrate strong proof-of-concept for trilaciclib's myelopreservation benefits.
CLINICAL TRAIL NUMBER


NCT02499770.",2019,No trilaciclib-related ≥ G3 AEs occurred.,"['treatment-naive extensive-stage small cell lung cancer (SCLC) patients', '122 patients were enrolled, with 19 patients in Part 1 and 75 patients in Part 2 receiving study drug', 'patients with small cell lung cancer receiving 1st-line chemotherapy']","['etoposide/carboplatin (E/P) therapy', 'trilaciclib or placebo', 'placebo', 'trilaciclib vs. placebo', 'Myelopreservation with the CDK4/6 inhibitor trilaciclib']","['ORR', 'median PFS', 'neutrophil, RBC and lymphocyte measures', 'hematological toxicity', 'myelosuppression and anti-tumor efficacy']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205435', 'cui_str': 'First (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression (finding)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]",122.0,0.302546,No trilaciclib-related ≥ G3 AEs occurred.,"[{'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Weiss', 'Affiliation': 'Division of Hematology and Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Csoszi', 'Affiliation': 'Oncology, Hetenyi Geza Korhaz, Onkologiai Kozpont, Szolnok, Hungary.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maglakelidze', 'Affiliation': 'Department of Oncology, Research Institute of Clinical Medicine, Tbilisi, Georgia, USA.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Hoyer', 'Affiliation': 'Department of Oncology, Memorial Hospital, University of Colorado Health, Colorado Springs, USA.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Beck', 'Affiliation': 'Department of Medical Oncology and Hematology, Highlands Oncology Group, Fayetteville, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Domine Gomez', 'Affiliation': 'Department of Oncology, University Hospital Fundacion Jimenez Diaz, IIS-FJD, Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lowczak', 'Affiliation': 'Department of Pulmonology, Faculty of Health and Science, University of Warmia and Mazury in Olsztyn, Poland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Aljumaily', 'Affiliation': 'Stephenson Cancer Center, University of Oklahoma, Oklahoma City, USA.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Rocha Lima', 'Affiliation': 'Gibbs Cancer Center and Research Institute, Spartanburg, USA.'}, {'ForeName': 'R V', 'Initials': 'RV', 'LastName': 'Boccia', 'Affiliation': 'Center for Cancer and Blood Disorders, Bethesda, USA.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Hanna', 'Affiliation': 'Hematology/Oncology, University of Tennessee Medical Center, Knoxville, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Nikolinakos', 'Affiliation': 'University Cancer & Blood Center, LLC, Athens, Greece.'}, {'ForeName': 'V K', 'Initials': 'VK', 'LastName': 'Chiu', 'Affiliation': 'Department of Hematology/Oncology, University of New Mexico Comprehensive Cancer Center, Albuquerque, USA.'}, {'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Owonikoko', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, USA.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Schuster', 'Affiliation': 'University of Colorado, Fort Collins, USA.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Hussein', 'Affiliation': 'Department of Oncology, Florida Cancer Specialists, Leesburg, USA.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Richards', 'Affiliation': 'Department of Oncology, US Oncology Research, Tyler, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sawrycki', 'Affiliation': 'Department of Cancer Chemotherapy, Provincial Hospital, Toruń, Poland.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bulat', 'Affiliation': 'ARENSIA Oncology Unit, Institute of Oncology, Chisinau, Moldova.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Hamm', 'Affiliation': 'Department of Medical Oncology, Norton Health Care, Louisville, USA.'}, {'ForeName': 'L L', 'Initials': 'LL', 'LastName': 'Hart', 'Affiliation': 'Drug Development Program, Floridia Cancer Specialists, Fort Myers, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Adler', 'Affiliation': 'Clinical Research, G1 Therapeutics, Inc., Research Triangle Park, USA.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Antal', 'Affiliation': 'Clinical Research, G1 Therapeutics, Inc., Research Triangle Park, USA.'}, {'ForeName': 'A Y', 'Initials': 'AY', 'LastName': 'Lai', 'Affiliation': 'Clinical Research, G1 Therapeutics, Inc., Research Triangle Park, USA.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Sorrentino', 'Affiliation': 'Clinical Research, G1 Therapeutics, Inc., Research Triangle Park, USA.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Clinical Research, G1 Therapeutics, Inc., Research Triangle Park, USA.'}, {'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Malik', 'Affiliation': 'Clinical Research, G1 Therapeutics, Inc., Research Triangle Park, USA.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Morris', 'Affiliation': 'Clinical Research, G1 Therapeutics, Inc., Research Triangle Park, USA.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Roberts', 'Affiliation': 'Clinical Research, G1 Therapeutics, Inc., Research Triangle Park, USA.'}, {'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Dragnev', 'Affiliation': 'Department of Hematology/Oncology, Norris Cotton Cancer Center Dartmouth-Hitchcock Medical Center, Lebanon, USA. Electronic address: konstantin.h.dragnev@hitchcock.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz278']
516,31560066,Apalutamide and overall survival in non-metastatic castration-resistant prostate cancer.,"BACKGROUND


In the SPARTAN study, compared with placebo, apalutamide added to ongoing androgen deprivation therapy significantly prolonged metastasis-free survival (MFS) and time to symptomatic progression in patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). Overall survival (OS) results at the first interim analysis (IA1) were immature, with 104 of 427 (24%) events required for planned final OS analysis. Here, we report the results of a second pre-specified interim analysis (IA2).
METHODS


One thousand two hundred and seven patients with nmCRPC were randomized 2 : 1 to apalutamide (240 mg daily) or placebo. The primary end point of the study was MFS. Subsequent therapy for metastatic CRPC was permitted. When the primary end point was met, the study was unblinded. Patients receiving placebo who had not yet developed metastases were offered open-label apalutamide. At IA2, pre-specified analysis of OS was undertaken, using a group-sequential testing procedure with O'Brien-Fleming-type alpha spending function. Safety and second progression-free survival (PFS2) were assessed.
RESULTS


Median follow-up was 41 months. With 285 (67% of required) OS events, apalutamide was associated with an improved OS compared with placebo (HR 0.75; 95% CI 0.59-0.96; P = 0.0197), although the P-value did not cross the pre-specified O'Brien-Fleming boundary of 0.0121. Apalutamide improved PFS2 (HR 0.55; 95% CI 0.45-0.68). At IA2, 69% of placebo-treated and 40% of apalutamide-treated patients had received subsequent life-prolonging therapy for metastatic CRPC. No new safety signals were observed.
CONCLUSION


In patients with nmCRPC, apalutamide was associated with a 25% reduction in risk of death compared with placebo. This OS benefit was observed despite crossover of placebo-treated patients and higher rates of subsequent life-prolonging therapy for the placebo group.",2019,Apalutamide improved PFS2 (HR 0.55; 95% CI 0.45-0.68).,"['One thousand two hundred and seven patients with nmCRPC', 'non-metastatic castration-resistant prostate cancer', 'patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC']","['placebo', 'placebo, apalutamide added to ongoing androgen deprivation therapy', 'apalutamide']","['Apalutamide improved PFS2', 'Overall survival (OS', 'Safety and second progression-free survival (PFS2', 'risk of death', 'Apalutamide and overall survival']","[{'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]","[{'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1207.0,0.43351,Apalutamide improved PFS2 (HR 0.55; 95% CI 0.45-0.68).,"[{'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA. Electronic address: Eric.Small@ucsf.edu.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montréal, QC, Canada.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chowdhury', 'Affiliation': ""Guy's, King's and St. Thomas' Hospitals, London; Sarah Cannon Research Institute, London, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'Georges Pompidou Hospital, University René Descartes, Paris, France.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Hadaschik', 'Affiliation': 'University of Duisburg-Essen, Essen; Ruprecht-Karls University Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'J N', 'Initials': 'JN', 'LastName': 'Graff', 'Affiliation': 'VA Portland Health Care System, Portland; Knight Cancer Institute, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Olmos', 'Affiliation': 'Spanish National Cancer Research Centre (CNIO), Madrid; Hospitales Universitarios Virgen de la Victoria y Regional, Institute of Biomedical Research in Málaga (IBIMA), Málaga, Spain.'}, {'ForeName': 'P N', 'Initials': 'PN', 'LastName': 'Mainwaring', 'Affiliation': 'Centre for Personalized Nanomedicine, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': ""St. Mary's Hospital of Catholic University, Seoul, South Korea.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Uemura', 'Affiliation': 'Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'De Porre', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Smith', 'Affiliation': 'Janssen Research & Development, Spring House, PA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Janssen Research & Development, San Diego, CA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lopez-Gitlitz', 'Affiliation': 'Janssen Research & Development, Los Angeles, CA.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Smith', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA; Harvard Medical School, Boston, MA, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz397']
517,31277077,Cardiorespiratory behavior of preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation: randomized crossover study.,"BACKGROUND


Nasal continuous positive airway pressure (NCPAP) and high flow nasal cannula (HFNC) are modes of non-invasive respiratory support commonly used after extubation in extremely preterm infants. However, the cardiorespiratory physiology of these infants on each mode is unknown.
METHODS


Prospective, randomized crossover study in infants with birth weight ≤1250 g undergoing their first extubation attempt. NCPAP and HFNC were applied randomly for 45 min each, while ribcage and abdominal movements, electrocardiogram, oxygen saturation, and fraction of inspired oxygen (FiO 2 ) were recorded. Respiratory signals were analyzed using an automated method, and differences between NCPAP and HFNC features and changes in FiO 2  were analyzed.
RESULTS


A total of 30 infants with median [interquartile range] gestational age of 27 weeks [25.7, 27.9] and birth weight of 930 g [780, 1090] were studied. Infants were extubated at 5 days [2, 13] of life with 973 g [880, 1170] and three failed (10%). No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
CONCLUSIONS


In extremely preterm infants studied shortly after extubation, the use of HFNC was associated with longer respiratory pauses and higher FiO 2  requirements.",2020,"No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
","['extremely preterm infants', 'infants with birth weight ≤1250', 'preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation', '30 infants with median [interquartile range] gestational age of 27 weeks [25.7, 27.9] and birth weight of 930\u2009g [780, 1090']","['HFNC', 'NCPAP and HFNC', 'Nasal continuous positive airway pressure (NCPAP) and high flow nasal cannula (HFNC']","['longer respiratory pauses', 'ribcage and abdominal movements, electrocardiogram, oxygen saturation, and fraction of inspired oxygen (FiO 2 ', 'cardiorespiratory behavior']","[{'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1258045', 'cui_str': 'Nasal Continuous Positive Airway Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0222762', 'cui_str': 'Thoracic Cage'}, {'cui': 'C1286159', 'cui_str': 'Movement of abdomen'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",30.0,0.118465,"No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
","[{'ForeName': 'Lara J', 'Initials': 'LJ', 'LastName': 'Kanbar', 'Affiliation': 'Department of Biomedical Engineering, Montreal, QC, Canada.'}, {'ForeName': 'Wissam', 'Initials': 'W', 'LastName': 'Shalish', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Latremouille', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Brown', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Kearney', 'Affiliation': 'Department of Biomedical Engineering, Montreal, QC, Canada.'}, {'ForeName': 'Guilherme M', 'Initials': 'GM', 'LastName': ""Sant'Anna"", 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada. guilherme.santanna@mcgill.ca.'}]",Pediatric research,['10.1038/s41390-019-0494-5']
518,32248846,Physiological responses to maximal eating in men.,"This study investigated metabolic, endocrine, appetite and mood responses to a maximal eating occasion in fourteen men (mean: age 28 (sd 5) years, body mass 77·2 (sd 6·6) kg and BMI 24·2 (sd 2·2) kg/m2) who completed two trials in a randomised crossover design. On each occasion, participants ate a homogenous mixed-macronutrient meal (pizza). On one occasion, they ate until 'comfortably full' (ad libitum) and on the other, until they 'could not eat another bite' (maximal). Mean energy intake was double in the maximal (13 024 (95 % CI 10 964, 15 084) kJ; 3113 (95 % CI 2620, 3605) kcal) compared with the ad libitum trial (6627 (95 % CI 5708, 7547) kJ; 1584 (95 % CI 1364, 1804) kcal). Serum insulin incremental AUC (iAUC) increased approximately 1·5-fold in the maximal compared with ad libitum trial (mean: ad libitum 43·8 (95 % CI 28·3, 59·3) nmol/l × 240 min and maximal 67·7 (95 % CI 47·0, 88·5) nmol/l × 240 min, P < 0·01), but glucose iAUC did not differ between trials (ad libitum 94·3 (95 % CI 30·3, 158·2) mmol/l × 240 min and maximal 126·5 (95 % CI 76·9, 176·0) mmol/l × 240 min, P = 0·19). TAG iAUC was approximately 1·5-fold greater in the maximal v. ad libitum trial (ad libitum 98·6 (95 % CI 69·9, 127·2) mmol/l × 240 min and maximal 146·4 (95 % CI 88·6, 204·1) mmol/l × 240 min, P < 0·01). Total glucagon-like peptide-1, glucose-dependent insulinotropic peptide and peptide tyrosine-tyrosine iAUC were greater in the maximal compared with ad libitum trial (P < 0·05). Total ghrelin concentrations decreased to a similar extent, but AUC was slightly lower in the maximal v. ad libitum trial (P = 0·02). There were marked differences on appetite and mood between trials, most notably maximal eating caused a prolonged increase in lethargy. Healthy men have the capacity to eat twice the energy content required to achieve comfortable fullness at a single meal. Postprandial glycaemia is well regulated following initial overeating, with elevated postprandial insulinaemia probably contributing.",2020,"Total GLP-1, GIP, and PYY iAUC were greater in the maximal compared with ad libitum trial (p < 0.05).","['Healthy men', 'fourteen men (mean ±SD: age 28 ±5 y, body mass 77.2 ±6.6 kg, body mass index 24.2 ±2.2 kg·m-2', 'men']",['homogenous mixed-macronutrient meal (pizza'],"['Postprandial glycaemia', 'comfortable fullness', 'lethargy', 'glucose', 'iAUC', 'Total GLP-1, GIP, and PYY iAUC', 'appetite and mood', 'TAG iAUC', 'Serum insulin iAUC', 'Total ghrelin concentrations']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0453577', 'cui_str': 'Pizza'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0037293', 'cui_str': 'Skin tag'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0966749,"Total GLP-1, GIP, and PYY iAUC were greater in the maximal compared with ad libitum trial (p < 0.05).","[{'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Hengist', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Edinburgh', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Russell G', 'Initials': 'RG', 'LastName': 'Davies', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Walhin', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Jariya', 'Initials': 'J', 'LastName': 'Buniam', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'James', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, LoughboroughLE11 3TU, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Rogers', 'Affiliation': 'School of Psychological Science, University of Bristol, BristolBS8 1TU, UK.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}]",The British journal of nutrition,['10.1017/S0007114520001270']
519,29898870,"Subtype C ALVAC-HIV and bivalent subtype C gp120/MF59 HIV-1 vaccine in low-risk, HIV-uninfected, South African adults: a phase 1/2 trial.","BACKGROUND


Modest efficacy was reported for the HIV vaccine tested in the RV144 trial, which comprised a canarypox vector (ALVAC) and envelope (env) glycoprotein (gp120). These vaccine components were adapted to express HIV-1 antigens from strains circulating in South Africa, and the adjuvant was changed to increase immunogenicity. Furthermore, 12-month immunisation was added to improve durability. In the HIV Vaccine Trials Network (HVTN) 100 trial, we aimed to assess this new regionally adapted regimen for advancement to efficacy testing.
METHODS


HVTN 100 is a phase 1/2, randomised controlled, double-blind trial at six community research sites in South Africa. We randomly allocated adults (aged 18-40 years) without HIV infection and at low risk of HIV infection to either the vaccine regimen (intramuscular injection of ALVAC-HIV vector [vCP2438] at 0, 1, 3, 6, and 12 months plus bivalent subtype C gp120 and MF59 adjuvant at 3, 6, and 12 months) or placebo, in a 5:1 ratio. Randomisation was done by computer-generated list. Participants, investigators, and those assessing outcomes were masked to random assignments. Primary outcomes included safety and immune responses associated with correlates of HIV risk in RV144, 2 weeks after vaccination at 6 months (month 6·5). We compared per-protocol participants (ie, those who completed the first four vaccinations and provided samples at month 6·5) from HVTN 100 with stored RV144 samples assayed contemporaneously. This trial is registered with the South African National Clinical Trials Registry (DOH-27-0215-4796) and ClinicalTrials.gov (NCT02404311).
FINDINGS


Between Feb 9, 2015, and May 26, 2015, 252 participants were enrolled, of whom 210 were assigned vaccine and 42 placebo. 222 participants were included in the per-protocol analysis (185 vaccine and 37 placebo). 185 (100%) vaccine recipients developed IgG binding antibodies to all three vaccine-matched gp120 antigens with significantly higher titres (3·6-8·8 fold; all p<0·0001) than the corresponding vaccine-matched responses of RV144. The CD4+ T-cell response to the ZM96.C env protein in HVTN 100 was 56·4% (n=102 responders), compared with a response of 41·4% (n=79 responders) to 92TH023.AE in RV144 (p=0·0050). The IgG response to the 1086.C variable loops 1 and 2 (V1V2) env antigen in HVTN 100 was 70·5% (95% CI 63·5-76·6; n=129 responders), lower than the response to V1V2 in RV144 (99·0%, 95% CI 96·4-99·7; n=199 responders).
INTERPRETATION


Although the IgG response to the HVTN 100 vaccine was lower than that reported in RV144, it exceeded the predicted 63% threshold needed for 50% vaccine efficacy using a V1V2 correlate of protection model. Thus, the subtype C HIV vaccine regimen qualified for phase 2b/3 efficacy testing, a critical next step of vaccine development.
FUNDING


US National Institute of Allergy and Infectious Diseases (NIAID), and Bill & Melinda Gates Foundation.",2018,185 (100%) vaccine recipients developed IgG binding antibodies to all three vaccine-matched gp120 antigens with significantly higher titres (3·6-8·8 fold; all p<0·0001) than the corresponding vaccine-matched responses of RV144.,"['HIV-uninfected, South African adults', 'randomly allocated adults (aged 18-40 years) without HIV infection and at low risk of HIV infection to either the', 'HVTN 100 is a phase 1/2, randomised controlled, double-blind trial at six community research sites in South Africa', '222 participants were included in the per-protocol analysis (185', 'Between Feb 9, 2015, and May 26, 2015, 252 participants were enrolled, of whom 210 were assigned vaccine and 42']","['vaccine and 37 placebo', 'placebo', 'vaccine regimen (intramuscular injection of ALVAC-HIV vector [vCP2438']","['safety and immune responses associated with correlates of HIV risk', 'durability', 'CD4+ T-cell response', 'IgG binding antibodies', 'IgG response']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035168'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C0675907', 'cui_str': 'ALVAC-HIV'}, {'cui': 'C0442335', 'cui_str': 'Vectors (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]",222.0,0.569438,185 (100%) vaccine recipients developed IgG binding antibodies to all three vaccine-matched gp120 antigens with significantly higher titres (3·6-8·8 fold; all p<0·0001) than the corresponding vaccine-matched responses of RV144.,"[{'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa. Electronic address: linda-gail.bekker@hiv-research.org.za.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Moodie', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Grunenberg', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Laher', 'Affiliation': 'Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Kristen W', 'Initials': 'KW', 'LastName': 'Cohen', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Allen', 'Affiliation': 'Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mookho', 'Initials': 'M', 'LastName': 'Malahleha', 'Affiliation': 'Setshaba Research Centre, Soshanguve, Pretoria, South Africa.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Mngadi', 'Affiliation': 'Centre for the Programme of Aids Research in South Africa (CAPRISA), Durban, South Africa; School of Laboratory Medicine and Medical Sciences, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Brodie', 'Initials': 'B', 'LastName': 'Daniels', 'Affiliation': 'South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Innes', 'Affiliation': 'The Aurum Institute, Klerksdorp Research Centre, Klerksdorp, South Africa.'}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Bentley', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Frahm', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Daryl E', 'Initials': 'DE', 'LastName': 'Morris', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Morris', 'Affiliation': 'National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.'}, {'ForeName': 'Nonhlanhla N', 'Initials': 'NN', 'LastName': 'Mkhize', 'Affiliation': 'National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Montefiori', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Sarzotti-Kelsoe', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Grant', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Chenchen', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Vijay L', 'Initials': 'VL', 'LastName': 'Mehra', 'Affiliation': 'Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Pensiero', 'Affiliation': 'Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Phogat', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'DiazGranados', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Barnett', 'Affiliation': 'GSK Vaccines, Cambridge, MA, USA; Bill & Melinda Gates Foundation, Seattle, WA, USA.'}, {'ForeName': 'Niranjan', 'Initials': 'N', 'LastName': 'Kanesa-Thasan', 'Affiliation': 'GSK Vaccines, Rockville, MD, USA; Kanesa LLC, Lexington, MA, USA.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Koutsoukos', 'Affiliation': 'GSK Vaccines, Rixensart, Belgium.'}, {'ForeName': 'Nelson L', 'Initials': 'NL', 'LastName': 'Michael', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Merlin L', 'Initials': 'ML', 'LastName': 'Robb', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Gilbert', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Glenda E', 'Initials': 'GE', 'LastName': 'Gray', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; South African Medical Research Council, Cape Town, South Africa.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(18)30071-7']
520,32247539,Remifentanil and perioperative glycaemic response in cardiac surgery: an open-label randomised trial.,"BACKGROUND


This study investigated whether remifentanil infusion decreased intraoperative hyperglycaemia and insulin resistance compared with intermittent fentanyl administration in patients undergoing elective cardiac surgery.
METHODS


This was a randomised, prospective, open-label trial. Patients undergoing elective cardiac surgery (n=116) were randomised to receive either continuous intravenous remifentanil infusion or intermittent fentanyl boluses. Hourly blood glucose values were obtained for 24 h starting from induction of anaesthesia. The difference in percentage of patients with ≥2 intraoperative blood glucose concentrations >10 mM (180 mg dl -1 ) between the groups was the primary outcome measure. Secondary outcome measures included insulin requirements, select stress hormone and inflammatory cytokine concentrations, and safety events and adverse outcomes.
RESULTS


The trial included 106 subjects in the final intention-to-treat analysis. There were fewer patients with ≥2 intraoperative blood glucose values >10 mM (180 mg dl -1 ) in the remifentanil group (17 [31.5%]) compared with the fentanyl group (33 [63.5%]) (relative risk: 0.50; 95% confidence interval [CI]: 0.32-0.77; P=0.001). The administered intraoperative insulin was a median of 8.1 units (range: 0-46.7) in the fentanyl group and 2.9 units (range: 0-35.1) in the remifentanil group (median difference=5 units; 95% CI: 1-7; P=0.004). Cortisol and adrenocorticotropic hormone were increased less in the remifentanil group (P<0.001), but there was no relative decrease in this group in select inflammatory cytokines. Postoperative measures of glycaemic control and adverse clinical outcomes were not significantly different between groups.
CONCLUSIONS


Compared with patients treated with intermittent fentanyl, patients receiving continuous remifentanil infusion had fewer episodes of hyperglycaemia and less need for insulin administration during the intraoperative period of cardiac surgery.
CLINICAL TRIAL REGISTRATION


NCT02349152.",2020,"Cortisol and adrenocorticotropic hormone were increased less in the remifentanil group (P<0.001), but there was no relative decrease in this group in select inflammatory cytokines.","['patients undergoing elective cardiac surgery', '106 subjects in the final intention-to-treat analysis', 'cardiac surgery', 'Patients undergoing elective cardiac surgery (n=116']","['remifentanil infusion', 'remifentanil', 'Remifentanil', 'continuous intravenous remifentanil infusion or intermittent fentanyl boluses']","['episodes of hyperglycaemia', '≥2 intraoperative blood glucose values', 'percentage of patients with ≥2 intraoperative blood glucose concentrations', 'Postoperative measures of glycaemic control and adverse clinical outcomes', 'Cortisol and adrenocorticotropic hormone', 'insulin requirements, select stress hormone and inflammatory cytokine concentrations, and safety events and adverse outcomes', 'intraoperative hyperglycaemia and insulin resistance', 'perioperative glycaemic response', 'Hourly blood glucose values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}]",106.0,0.436534,"Cortisol and adrenocorticotropic hormone were increased less in the remifentanil group (P<0.001), but there was no relative decrease in this group in select inflammatory cytokines.","[{'ForeName': 'Kathirvel', 'Initials': 'K', 'LastName': 'Subramaniam', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. Electronic address: skathirvel@gmail.com.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sciortino', 'Affiliation': 'Department of Cardiothoracic Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Ruppert', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Monroe', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Esper', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boisen', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Marquez', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Hayanga', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Badhwar', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, West Virginia University, Morgantown, WV, USA.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.01.028']
521,32248243,GAD-alum immunotherapy in type 1 diabetes expands bifunctional Th1/Th2 autoreactive CD4 T cells.,"AIMS/HYPOTHESIS


Antigen-specific therapy aims to modify inflammatory T cell responses in type 1 diabetes and restore immune tolerance. One strategy employs GAD65 conjugated to aluminium hydroxide (GAD-alum) to take advantage of the T helper (Th)2-biasing adjuvant properties of alum and thereby regulate pathological Th1 autoimmunity. We explored the cellular and molecular mechanism of GAD-alum action in the setting of a previously reported randomised placebo-controlled clinical trial conducted by Type 1 Diabetes TrialNet.
METHODS


In the clinical trial conducted by Type 1 Diabetes TrialNet, participants were immunised with 20 μg GAD-alum (twice or three times) or alum alone and peripheral blood mononuclear cell samples were banked at baseline and post treatment. In the present study, GAD-specific T cell responses were measured in these samples and GAD-specific T cell lines and clones were generated, which were then further characterised.
RESULTS


At day 91 post immunisation, we detected GAD-specific IL-13 +  CD4 T cell responses significantly more frequently in participants immunised with GAD-alum (71% and 94% treated twice or three times, respectively) compared with those immunised with alum alone (38%; p = 0.003 and p = 0.0002, respectively) accompanied by high secreted levels of IL-13, IL-4 and IL-5, confirming a GAD-specific, GAD-alum-induced Th2 response. Of note, GAD-specific, IL-13 +  CD4 T cells observed after immunisation co-secreted IFN-γ, displaying a bifunctional Th1/Th2 phenotype. Single-cell transcriptome analysis identified IL13 and IFNG expression in concert with the canonical Th2 and Th1 transcription factor genes GATA3 and TBX21, respectively. T cell receptor β-chain (TCRB) CDR3 regions of GAD-specific bifunctional T cells were identified in circulating naive and central memory CD4 T cell pools of non-immunised participants with new-onset type 1 diabetes and healthy individuals, suggesting the potential for bifunctional responses to be generated de novo by GAD-alum immunisation or via expansion from an existing public repertoire.
CONCLUSIONS/INTERPRETATION


GAD-alum immunisation activates and propagates GAD-specific CD4 T cells with a distinctive bifunctional phenotype, the functional analysis of which might be important in understanding therapeutic responses.",2020,"At day 91 post immunisation, we detected GAD-specific IL-13 +  CD4 T cell responses significantly more frequently in participants immunised with GAD-alum (71% and 94% treated twice or three times, respectively) compared with those immunised with alum alone (38%; p = 0.003 and p = 0.0002, respectively) accompanied by high secreted levels of IL-13, IL-4 and IL-5, confirming a GAD-specific, GAD-alum-induced Th2 response.",[],"['aluminium hydroxide (GAD-alum', 'placebo', 'GAD-alum immunotherapy']","['GAD-specific IL-13 +  CD4 T cell responses', 'IL-13, IL-4 and IL-5, confirming a GAD-specific, GAD-alum-induced Th2 response', 'GAD-specific, IL-13 +  CD4 T cells', 'GAD-specific T cell responses', 'IL13 and IFNG expression', 'T cell receptor β-chain (TCRB']",[],"[{'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder'}, {'cui': 'C0051522', 'cui_str': 'aluminum sulfate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0214743', 'cui_str': 'Interleukin 13'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0051522', 'cui_str': 'aluminum sulfate'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0034790', 'cui_str': 'T-cell antigen receptor'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0087049', 'cui_str': 'T-Cell Receptors beta-Chain'}]",,0.0923879,"At day 91 post immunisation, we detected GAD-specific IL-13 +  CD4 T cell responses significantly more frequently in participants immunised with GAD-alum (71% and 94% treated twice or three times, respectively) compared with those immunised with alum alone (38%; p = 0.003 and p = 0.0002, respectively) accompanied by high secreted levels of IL-13, IL-4 and IL-5, confirming a GAD-specific, GAD-alum-induced Th2 response.","[{'ForeName': 'Sefina', 'Initials': 'S', 'LastName': 'Arif', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Iria', 'Initials': 'I', 'LastName': 'Gomez-Tourino', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Yogesh', 'Initials': 'Y', 'LastName': 'Kamra', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Pujol-Autonell', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hanton', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Tree', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Melandri', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hull', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Diane K', 'Initials': 'DK', 'LastName': 'Wherrett', 'Affiliation': 'Division of Endocrinology, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Beam', 'Affiliation': 'Homer Stryker MD School of Medicine, Western Michigan University, Kalamazoo, MI, USA.'}, {'ForeName': 'Bart O', 'Initials': 'BO', 'LastName': 'Roep', 'Affiliation': 'Diabetes and Metabolism Research Institute, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lorenc', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Peakman', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK. mark.peakman@kcl.ac.uk.""}]",Diabetologia,['10.1007/s00125-020-05130-7']
522,30394918,The Effect of Propofol and Dexmedetomidine Sedation on Norepinephrine Requirements in Septic Shock Patients: A Crossover Trial.,"OBJECTIVES


Propofol-based sedation may increase hemodynamic instability by decreasing vascular tone and venous return. Incremental exogenous catecholamines doses may be required to counteract such effects, aggravating the deleterious effects of sympathetic overstimulation. α-2 adrenergic agonists have been reported to decrease norepinephrine requirements in experimental septic shock. The aim of the present study is to test the hypothesis that switching from sedation with propofol to the α-2 agonist dexmedetomidine may decrease norepinephrine doses in septic shock.
DESIGN


Prospective open-label crossover study.
SETTINGS


University hospital, ICU.
PATIENTS


Thirty-eight septic shock patients requiring norepinephrine to maintain adequate mean arterial pressure and needing deep sedation with propofol and remifentanil to maintain a Richmond Agitation-Sedation Scale score between -3 and -4.
INTERVENTIONS


An initial set of measurements including hemodynamics, norepinephrine doses, and depth of sedation were obtained during sedation with propofol. Propofol was then replaced by dexmedetomidine and a second set of data was obtained after 4 hours of dexmedetomidine infusion. Sedation was switched back to propofol, and a final set of measurements was obtained after 8 hours. A Richmond Agitation-Sedation Scale score between -3 and -4 was maintained during the study period.
MEASUREMENTS AND MAIN RESULTS


Norepinephrine requirements decreased from 0.69 ± 0.72 μg/kg/min before dexmedetomidine to 0.30 ± 0.25 μg/kg/min 4 hours after dexmedetomidine infusion, increasing again to 0.42 ± 0.36 μg/kg/min while on propofol 8 hours after stopping dexmedetomidine (p < 0.005). Dexmedetomidine dosage was 0.7 ± 0.2 μg/kg/hr. Before and after dexmedetomidine infusion, sedative doses remained unchanged (propofol 2.6 ± 1.2 vs 2.6 ± 1.2 mg/kg/hr; p = 0.23 and remifentanil 1.27 ± 0.17 vs 1.27 ± 0.16 μg/kg/hr; p = 0.52, respectively). Richmond Agitation-Sedation Scale was -4 (-4 to -3) before, -4 (-4 to -3) during, and -4 (-4 to -4) after dexmedetomidine (p = 0.07).
CONCLUSIONS


For a comparable level of sedation, switching from propofol to dexmedetomidine resulted in a reduction of catecholamine requirements in septic shock patients.",2019,"For a comparable level of sedation, switching from propofol to dexmedetomidine resulted in a reduction of catecholamine requirements in septic shock patients.","['University hospital, ICU', 'Septic Shock Patients', 'Thirty-eight septic shock patients requiring norepinephrine to maintain adequate mean arterial pressure and needing deep sedation with propofol and remifentanil to maintain a Richmond Agitation-Sedation Scale score between -3', 'septic shock patients']","['Dexmedetomidine', 'Dexmedetomidine Sedation', 'propofol', 'dexmedetomidine', 'Propofol', 'Propofol-based sedation']","['catecholamine requirements', 'A Richmond Agitation-Sedation Scale score', 'norepinephrine requirements', 'Norepinephrine Requirements', 'hemodynamics, norepinephrine doses, and depth of sedation', 'Richmond Agitation-Sedation Scale', 'Norepinephrine requirements']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C1956064', 'cui_str': 'Deep Sedation'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0007412', 'cui_str': 'Sympathins'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]",38.0,0.0433258,"For a comparable level of sedation, switching from propofol to dexmedetomidine resulted in a reduction of catecholamine requirements in septic shock patients.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Morelli', 'Affiliation': 'Department of Cardiovascular, Respiratory, Nephrological, Anesthesiological and Geriatric Sciences, University of Rome, ""La Sapienza,"" Policlinico Umberto Primo, Viale del Policlinico, Rome, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Sanfilippo', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS-ISMETT (Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione), Via Ernesto Tricomi, Palermo, Italy.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Arnemann', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital of Muenster, Albert-Schweitzer-Campus, Muenster, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hessler', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital of Muenster, Albert-Schweitzer-Campus, Muenster, Germany.'}, {'ForeName': 'Tim G', 'Initials': 'TG', 'LastName': 'Kampmeier', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital of Muenster, Albert-Schweitzer-Campus, Muenster, Germany.'}, {'ForeName': 'Annalia', 'Initials': 'A', 'LastName': ""D'Egidio"", 'Affiliation': 'Department of Cardiovascular, Respiratory, Nephrological, Anesthesiological and Geriatric Sciences, University of Rome, ""La Sapienza,"" Policlinico Umberto Primo, Viale del Policlinico, Rome, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Orecchioni', 'Affiliation': 'Department of Cardiovascular, Respiratory, Nephrological, Anesthesiological and Geriatric Sciences, University of Rome, ""La Sapienza,"" Policlinico Umberto Primo, Viale del Policlinico, Rome, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Santonocito', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS-ISMETT (Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione), Via Ernesto Tricomi, Palermo, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Frati', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, University of Rome ""La Sapienza,"" Corso della Repubblica, Latina, Italy.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Greco', 'Affiliation': 'Department of Cardiovascular, Respiratory, Nephrological, Anesthesiological and Geriatric Sciences, University of Rome, ""La Sapienza,"" Policlinico Umberto Primo, Viale del Policlinico, Rome, Italy.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Westphal', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital of Muenster, Albert-Schweitzer-Campus, Muenster, Germany.'}, {'ForeName': 'Sebastian W', 'Initials': 'SW', 'LastName': 'Rehberg', 'Affiliation': 'Department of Anesthesiology, Intensive Care, Emergency Medicine, Transfusion Medicine and Pain Therapy, Protestant Hospital of the Bethel Foundation, Burgsteig, Bielefeld, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ertmer', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital of Muenster, Albert-Schweitzer-Campus, Muenster, Germany.'}]",Critical care medicine,['10.1097/CCM.0000000000003520']
523,31939063,"Long-term Efficacy, Safety, and Immunogenicity of the Infliximab (IFX) Biosimilar, PF-06438179/GP1111, in Patients with Rheumatoid Arthritis After Switching from Reference IFX or Continuing Biosimilar Therapy: Week 54-78 Data From a Randomized, Double-Blind, Phase III Trial.","OBJECTIVE


Our objective was to evaluate the long-term efficacy, safety, and immunogenicity of the infliximab biosimilar, PF-06438179/GP1111 (PF-SZ-IFX), in patients with rheumatoid arthritis (RA) who continued biosimilar treatment throughout 78 weeks or who switched from reference infliximab (Remicade ® ) sourced from the EU (IFX-EU) at week 30 or week 54 in the REFLECTIONS B537-02 study.
METHODS


In this phase III, double-blind, active-controlled study, patients with moderate-to-severe active RA were initially randomized to PF-SZ-IFX or IFX-EU, each with methotrexate (treatment period [TP] 1; N = 650). At week 30, patients receiving PF-SZ-IFX continued PF-SZ-IFX; patients receiving IFX-EU were re-randomized to continue IFX-EU or switch to PF-SZ-IFX (TP2; n = 566). From weeks 54 to 78, all patients received open-label treatment with PF-SZ-IFX (TP3; n = 505). Efficacy, safety, and immunogenicity data were analyzed during TP3.
RESULTS


Efficacy was sustained and comparable across groups at week 78, with American College of Rheumatology criteria for ≥ 20% clinical improvement response rates of 75.9% (biosimilar group), 77.8% (week 30 switch group), and 68.3% (week 54 switch group). The incidence of treatment-emergent adverse events was 28.9%, 29.4%, and 30.2%, respectively. The proportion of patients who were antidrug antibody (ADA) positive and neutralizing antibody positive (as a percentage of ADA-positive patients) was stable and comparable between groups.
CONCLUSIONS


Results to week 78 continue to support the efficacy, safety, and immunogenicity of PF-SZ-IFX in patients with moderate-to-severe active RA. There were no clinically meaningful differences between groups, independent of a single treatment transition from IFX-EU to PF-SZ-IFX at week 30 or week 54.
TRIAL REGISTRATION NUMBER


NCT02222493.",2020,"Efficacy was sustained and comparable across groups at week 78, with American College of Rheumatology criteria for ≥ 20% clinical improvement response rates of 75.9% (biosimilar group), 77.8% (week 30 switch group), and 68.3% (week 54 switch group).","['patients with moderate-to-severe active RA', 'patients with rheumatoid arthritis (RA) who continued biosimilar treatment throughout 78\xa0weeks or who switched from reference infliximab (Remicade ® ) sourced from the EU (IFX-EU) at week 30 or week 54 in the REFLECTIONS B537-02 study', 'Patients with Rheumatoid Arthritis']","['PF-SZ-IFX or IFX-EU, each with methotrexate', 'infliximab biosimilar, PF-06438179/GP1111 (PF-SZ-IFX', 'Infliximab (IFX', 'open-label treatment with PF-SZ-IFX (TP3']","['efficacy, safety, and immunogenicity', 'incidence of treatment-emergent adverse events', 'Efficacy', 'Efficacy, safety, and immunogenicity data', 'long-term efficacy, safety, and immunogenicity', 'antidrug antibody (ADA) positive and neutralizing antibody positive']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0723012', 'cui_str': 'Remicade'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0075032', 'cui_str': 'TP3'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0741132', 'cui_str': 'Antibody test positive'}, {'cui': 'C1609515', 'cui_str': 'Neutralising antibodies positive'}]",650.0,0.0748742,"Efficacy was sustained and comparable across groups at week 78, with American College of Rheumatology criteria for ≥ 20% clinical improvement response rates of 75.9% (biosimilar group), 77.8% (week 30 switch group), and 68.3% (week 54 switch group).","[{'ForeName': 'Stanley B', 'Initials': 'SB', 'LastName': 'Cohen', 'Affiliation': 'Metroplex Clinical Research Center, Dallas, TX, USA. arthdoc@aol.com.'}, {'ForeName': 'Sebastiao C', 'Initials': 'SC', 'LastName': 'Radominski', 'Affiliation': 'Universidade Federal do Paraná, Rua General Carneiro, 181-Alto Da Glória, Curitiba, PR, 80060-900, Brazil.'}, {'ForeName': 'Hideto', 'Initials': 'H', 'LastName': 'Kameda', 'Affiliation': 'Toho University, 2-22-36, Ohashi Meguro-ku, Tokyo, 153-8515, Japan.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tee', 'Affiliation': 'Department of Medicine, Medical Center Manila, University of the Philippines, Manila, Philippines.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Cronenberger', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Pfizer Inc, La Jolla, CA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hackley', 'Affiliation': 'Pfizer R&D UK, Ltd, Sandwich, Kent, UK.'}, {'ForeName': 'Muhammad I', 'Initials': 'MI', 'LastName': 'Rehman', 'Affiliation': 'Pfizer Inc, Andover, MA, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'von Richter', 'Affiliation': 'Biopharmaceuticals, Hexal AG (a Sandoz company), Holzkirchen, Germany.'}, {'ForeName': 'Rieke', 'Initials': 'R', 'LastName': 'Alten', 'Affiliation': 'Schlosspark-Klinik University Medicine, Heubnerweg 2, 14059, Berlin, Germany.'}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-019-00403-z']
524,32249668,Cognitively Challenging Agility Boot Camp Program for Freezing of Gait in Parkinson Disease.,"Introduction . It is well documented that freezing of gait (FoG) episodes occur in situations that are mentally challenging, such as dual tasks, consistent with less automatic control of gait in people with Parkinson disease (PD) and FoG. However, most physical rehabilitation does not include such challenges. The purpose was to determine (1) feasibility of a cognitively challenging Agility Boot Camp-Cognitive (ABC-C) program and (2) effects of this intervention on FoG, dual-task cost, balance, executive function, and functional connectivity.  Methods . A total of 46 people with PD and FoG enrolled in this randomized crossover trial. Each participant had 6 weeks of ABC-C and Education interventions. Outcome measures were the following: FoG, perceived and objective measures; dual-task cost on gait; balance; executive function; and right supplementary motor area (SMA)-pedunculopontine nucleus (PPN) functional connectivity. Effect sizes were calculated.  Results . ABC-C had high compliance (90%), with a 24% dropout rate. Improvements after exercise, revealed by moderate and large effect sizes, were observed for subject perception of FoG after exercise, dual-task cost on gait speed, balance, cognition (Scales for Outcomes in Parkinson's disease-Cognition), and SMA-PPN connectivity.  Conclusions . The ABC-C for people with PD and FoG is a feasible exercise program that has potential to improve FoG, balance, dual-task cost, executive function, and brain connectivity. The study provided effect sizes to help design future studies with more participants and longer duration to fully determine the potential to improve FoG.",2020,"The ABC-C for people with PD and FoG is a feasible exercise program that has potential to improve FoG, balance, dual-task cost, executive function, and brain connectivity.","['people with Parkinson disease (PD) and FoG', '46 people with PD and FoG enrolled']","['cognitively challenging Agility Boot Camp-Cognitive (ABC-C) program', 'Cognitively Challenging Agility Boot Camp Program']","['FoG, balance, dual-task cost, executive function, and brain connectivity', ""subject perception of FoG after exercise, dual-task cost on gait speed, balance, cognition (Scales for Outcomes in Parkinson's disease-Cognition), and SMA-PPN connectivity"", 'FoG, dual-task cost, balance, executive function, and functional connectivity', 'FoG, perceived and objective measures; dual-task cost on gait; balance; executive function; and right supplementary motor area (SMA)-pedunculopontine nucleus (PPN) functional connectivity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0450030', 'cui_str': 'Fog'}]","[{'cui': 'C0331794', 'cui_str': 'Boots'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0450030', 'cui_str': 'Fog'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C1527386', 'cui_str': 'Peripheral line feeding'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}, {'cui': 'C0262306', 'cui_str': 'Nucleus Tegmentalis Pedunculopontinus'}]",46.0,0.0271566,"The ABC-C for people with PD and FoG is a feasible exercise program that has potential to improve FoG, balance, dual-task cost, executive function, and brain connectivity.","[{'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'King', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mancini', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Katrijn', 'Initials': 'K', 'LastName': 'Smulders', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Harker', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Jodi A', 'Initials': 'JA', 'LastName': 'Lapidus', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Ramsey', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Carlson-Kuhta', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Brett W', 'Initials': 'BW', 'LastName': 'Fling', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Nutt', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Peterson', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Fay B', 'Initials': 'FB', 'LastName': 'Horak', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320909331']
525,31977595,Brief Report: Virologic Response by Baseline Viral Load With Dolutegravir Plus Lamivudine vs Dolutegravir Plus Tenofovir Disoproxil Fumarate/Emtricitabine: Pooled Analysis.,"BACKGROUND


To investigate antiviral potency of the 2-drug regimen (2DR) dolutegravir plus lamivudine vs the 3-drug regimen (3DR) dolutegravir plus tenofovir disoproxil fumarate/emtricitabine, we performed a post-hoc analysis assessing antiviral response rates in the phase III GEMINI-1 and GEMINI-2 studies by baseline viral load (VL).
SETTING


One hundred ninety-two centers in 21 countries.
METHODS


Treatment-naive HIV-1-infected participants with screening VL ≤500,000 copies/mL were randomized 1:1 to once-daily dolutegravir plus lamivudine or dolutegravir plus tenofovir disoproxil fumarate/emtricitabine. Median change from baseline was determined for log10-transformed VL in the overall study population and the subpopulation with baseline VL >100,000 copies/mL. Proportion of participants achieving plasma VL <50 copies/mL (Snapshot algorithm) or <40 copies/mL (Abbott RealTime HIV-1 assay) and target not detected was assessed through week 48 by baseline VL. Time to viral suppression was determined (nonparametric Kaplan-Meier method).
RESULTS


For 293 participants with baseline VL >100,000 copies/mL, median change from baseline at week 4 was -3.38 and -3.40 log10 copies/mL in the 2DR and 3DR groups, respectively; reduction was sustained throughout 48 weeks. Time to VL <50 copies/mL was longer in participants with baseline VL >100,000 copies/mL than the overall study population (57 [week 8] vs 29 days [week 4]) and similar between the 2DR and 3DR groups. Proportion of participants with VL <50 or <40 copies/mL and target not detected was similar between groups, irrespective of baseline VL, at all tested visits throughout 48 weeks.
CONCLUSION


Dolutegravir plus lamivudine demonstrates high antiviral potency in treatment-naive HIV-1-infected individuals across baseline VL strata.",2020,"Time to VL <50 copies/mL was longer in participants with baseline VL >100,000 copies/mL than the overall study population (57 [Week 8] vs 29 days [Week 4]) and similar between the 2DR and 3DR groups.","['Treatment-naive HIV-1-infected participants with screening VL <500,000 copies/mL', '192 centers in 21 countries']","['Dolutegravir plus lamivudine', 'daily dolutegravir plus lamivudine or dolutegravir plus tenofovir disoproxil fumarate/emtricitabine', 'lamivudine', 'Dolutegravir Plus Lamivudine vs Dolutegravir Plus Tenofovir Disoproxil Fumarate/Emtricitabine', 'tenofovir disoproxil fumarate/emtricitabine']","['antiviral potency', 'Time to viral suppression', 'antiviral response rates', 'Virologic Response']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}]","[{'cui': 'C1874329', 'cui_str': 'Antivirals, topical'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0205466', 'cui_str': 'virology'}]",293.0,0.414981,"Time to VL <50 copies/mL was longer in participants with baseline VL >100,000 copies/mL than the overall study population (57 [Week 8] vs 29 days [Week 4]) and similar between the 2DR and 3DR groups.","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Eron', 'Affiliation': 'University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Chien-Ching', 'Initials': 'CC', 'LastName': 'Hung', 'Affiliation': 'National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Jean-Guy', 'Initials': 'JG', 'LastName': 'Baril', 'Affiliation': 'Clinique Médicale du Quartier Latin, Montréal, Québec, Canada.'}, {'ForeName': 'Jihad', 'Initials': 'J', 'LastName': 'Slim', 'Affiliation': ""Saint Michael's Medical Center, Newark, NJ.""}, {'ForeName': 'Vicenç', 'Initials': 'V', 'LastName': 'Falcó', 'Affiliation': ""Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Bogner', 'Affiliation': 'Internal Medicine IV, University Hospital Munich, Munich, Germany.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Maggiolo', 'Affiliation': 'ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Mills', 'Affiliation': ""Men's Health Foundation, Los Angeles CA.""}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Sievers', 'Affiliation': 'ViiV Healthcare, Brentford, United Kingdom.'}, {'ForeName': 'Choy Y', 'Initials': 'CY', 'LastName': 'Man', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Rimgaile', 'Initials': 'R', 'LastName': 'Urbaityte', 'Affiliation': 'GlaxoSmithKline, London, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Allan R', 'Initials': 'AR', 'LastName': 'Tenorio', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Pappa', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Wynne', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Koteff', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gartland', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Kimberly Y', 'Initials': 'KY', 'LastName': 'Smith', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Aboud', 'Affiliation': 'ViiV Healthcare, Brentford, United Kingdom.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002302']
526,31820339,"A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera ® ) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL).","BACKGROUND


Biosimilars are highly similar to the licensed biologic (""reference product""), with no clinically meaningful differences in safety, purity, or potency between the two products.
OBJECTIVE


This comparative 52-week clinical study evaluated the efficacy, safety, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-05280586 (Ruxience™ [a rituximab biosimilar]) versus rituximab reference product sourced from the EU (MabThera ® ; rituximab-EU).
PATIENTS AND METHODS


Subjects with CD20-positive, low-tumor-burden follicular lymphoma (LTB-FL) and an Eastern Cooperative Oncology Group performance status 0-1 were randomized (1:1) to PF-05280586 or rituximab-EU (375 mg/m 2  intravenously [once weekly for 4 weeks at days 1, 8, 15, and 22]), stratified using the Follicular Lymphoma International Prognostic Index 2 classification. The primary endpoint was overall response rate (ORR) at week 26 (percentage of subjects achieving complete response [CR] or partial response [PR]). Therapeutic equivalence was concluded if the two-sided 95% confidence interval (CI) for the difference in ORR between groups was within the prespecified margin (± 16%). Secondary endpoints included progression-free survival (PFS), CR rate, safety, immunogenicity, PK, and PD.
RESULTS


A total of 394 subjects were randomized: PF-05280586 (n = 196) or rituximab-EU (n = 198). ORR at week 26 was 75.5% (PF-05280586) versus 70.7% (rituximab-EU), for a difference of 4.66%; 95% CI (- 4.16 to 13.47), which was entirely within the prespecified equivalence margin. Rates of CR were 29.3% (PF-05280586) versus 31.0% (rituximab-EU). Estimated 1-year PFS rates were 78.2% (95% CI 70.2-84.2) and 83.0% (95% CI 75.0-88.6) for PF-05280586 and rituximab-EU, respectively. Safety, immunogenicity, and mean serum concentrations were similar between groups.
CONCLUSIONS


The efficacy, safety, immunogenicity, PK, and PD of PF-05280586 and rituximab-EU were similar up to week 52 in subjects with previously untreated CD20-positive LTB-FL.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT02213263 and EudraCT (2014-000132-41).",2020,"Estimated 1-year PFS rates were 78.2% (95% CI 70.2-84.2) and 83.0% (95% CI 75.0-88.6) for PF-05280586 and rituximab-EU, respectively.","['Subjects with CD20-positive, low-tumor-burden follicular lymphoma (LTB-FL) and an Eastern Cooperative Oncology Group performance status 0-1', 'subjects with previously untreated CD20-positive LTB-FL', 'A total of 394 subjects', 'Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL']","['rituximab-EU', 'PF-05280586 or rituximab-EU', 'Rituximab Reference Product (MabThera ® ', 'rituximab reference product sourced from the EU (MabThera ® ; rituximab-EU', 'PF-05280586 (a Rituximab Biosimilar', 'PF-05280586']","['Therapeutic equivalence', 'Rates of CR', 'progression-free survival (PFS), CR rate, safety, immunogenicity, PK, and PD', 'efficacy, safety, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD', 'overall response rate (ORR', 'Estimated 1-year PFS rates', 'complete response [CR] or partial response [PR', 'Safety, immunogenicity, and mean serum concentrations', 'ORR', 'efficacy, safety, immunogenicity, PK, and PD of PF-05280586 and rituximab-EU']","[{'cui': 'C3888518', 'cui_str': 'CD20 antigen positive'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1449699', 'cui_str': 'Tumor Load'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C1664181', 'cui_str': 'LTB protein, human'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C1314901', 'cui_str': 'Mabthera'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]",394.0,0.51071,"Estimated 1-year PFS rates were 78.2% (95% CI 70.2-84.2) and 83.0% (95% CI 75.0-88.6) for PF-05280586 and rituximab-EU, respectively.","[{'ForeName': 'Jeff P', 'Initials': 'JP', 'LastName': 'Sharman', 'Affiliation': 'Willamette Valley Cancer Institute and Research Center, US Oncology, 520 Country Club Rd, Eugene, OR, 97401, USA.'}, {'ForeName': 'Anna Marina', 'Initials': 'AM', 'LastName': 'Liberati', 'Affiliation': 'Università degli Studi di Perugia, S.C. Oncoematologia-A.O. Santa Maria, 05100, Terni, Italy.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Ishizawa', 'Affiliation': 'Department of Third Internal Medicine, Faculty of Medicine, Yamagata University, 2-2-2 Iida-Nishi, Yamagata, 990-9585, Japan.'}, {'ForeName': 'Tahira', 'Initials': 'T', 'LastName': 'Khan', 'Affiliation': 'Pfizer Inc, 445 Eastern Point Rd, Groton, 06340, CT, USA. Tahira.Khan@pfizer.com.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Robbins', 'Affiliation': 'Pfizer Inc, 445 Eastern Point Rd, Groton, 06340, CT, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Alcasid', 'Affiliation': 'Pfizer Inc, 500 Arcola Rd, Collegeville, 19426, PA, USA.'}, {'ForeName': 'Julie Ann', 'Initials': 'JA', 'LastName': 'Rosenberg', 'Affiliation': 'Pfizer Inc, 445 Eastern Point Rd, Groton, 06340, CT, USA.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Aurer', 'Affiliation': 'University Hospital Centre Zagreb, Kišpatićeva ul. 12, 10000, Zagreb, Croatia.'}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-019-00398-7']
527,32052313,"Pharmacokinetic Similarity and Comparative Pharmacodynamics, Safety, Efficacy, and Immunogenicity of DRL_RI Versus Reference Rituximab in Biologics-Naïve Patients with Moderate-to-Severe Rheumatoid Arthritis: A Double-Blind, Randomized, Three-Arm Study.","OBJECTIVES


The aims were to demonstrate pharmacokinetic (PK) similarity between DRL_RI, a proposed rituximab biosimilar, and two reference innovator products (Rituxan ®  [RTX-US] and MabThera ®  [RTX-EU]) and compare their pharmacodynamics (PD), efficacy, safety, and immunogenicity in rheumatoid arthritis (RA) patients with inadequate response to methotrexate (MTX)-based therapy and no prior biologic administration.
METHODS


In this randomized, double-blind, parallel-group study, 276 patients with moderate-to-severe active RA were randomized to receive DRL_RI, RTX-US, or RTX-EU on days 1 and 15. The primary PK end points included area under the concentration-time curve from time 0 to 336 h after first infusion (AUC 0-14 days, first infusion ), AUC from day 1 through week 16 (AUC 0-∞, entire course ), and AUC from time 0 to time of last quantifiable concentration after the second dose (AUC 0-t, second infusion ). Secondary end points included other PK parameters, such as maximum concentration (C max ), time to C max  after each infusion, terminal half-life, systemic clearance, and volume of distribution after the second infusion; PD parameters and efficacy until week 24; safety and immunogenicity at week 24 and 52; and B cell recovery until week 52. AUC from time 0 to time of last quantifiable concentration after the first dose and over the entire course from day 1 through week 16 (AUC 0-t, entire course ) was analyzed as an exploratory end point.
RESULTS


The 91% confidence intervals (CIs) of the geometric mean ratios (GMRs) for the primary end point of AUC 0-∞, entire course  were within the bioequivalence limits of 80-125% for all comparisons: DRL_RI versus RTX-US 100.37% (92.30-109.14), DRL_RI versus RTX-EU 93.58% (85.98-101.85), and RTX-US versus RTX-EU 93.24% (85.62-101.54). PD outcomes (peripheral blood B-cell depletion and mean change in Disease Activity Score [28 joints]-C-reactive protein), efficacy, safety, and immunogenicity were also comparable between DRL_RI and the reference products.
CONCLUSION


DRL_RI, a proposed biosimilar, demonstrated three-way PK similarity with RTX-EU and RTX-US, the reference innovator products, with comparable efficacy, PD, safety, and immunogenicity.
CLINICAL TRIALS REGISTRATION NUMBER


ClinicalTrials.gov identifier: NCT02296775.",2020,"The 91% confidence intervals (CIs) of the geometric mean ratios (GMRs) for the primary end point of AUC 0-∞, entire course  were within the bioequivalence limits of 80-125% for all comparisons: DRL_RI versus RTX-US 100.37% (92.30-109.14), DRL_RI versus RTX-EU 93.58% (85.98-101.85), and RTX-US versus RTX-EU 93.24% (85.62-101.54).","['276 patients with moderate-to-severe active RA', 'rheumatoid arthritis (RA) patients with inadequate response to methotrexate (MTX)-based therapy and no prior biologic administration', 'Biologics-Naïve Patients with Moderate-to-Severe Rheumatoid Arthritis']","['DRL_RI Versus Reference Rituximab', 'DRL_RI, RTX-US, or RTX-EU']","['mean change in Disease Activity Score [28\xa0joints]-C-reactive protein), efficacy, safety, and immunogenicity', 'Pharmacokinetic Similarity and Comparative Pharmacodynamics, Safety, Efficacy, and Immunogenicity', 'PK parameters, such as maximum concentration (C max ), time to C max  after each infusion, terminal half-life, systemic clearance, and volume of distribution after the second infusion; PD parameters and efficacy until week 24; safety and immunogenicity', 'efficacy, PD, safety, and immunogenicity', 'PD outcomes (peripheral blood B-cell depletion and', 'geometric mean ratios (GMRs', 'pharmacodynamics (PD), efficacy, safety, and immunogenicity', 'area under the concentration-time curve']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",276.0,0.255532,"The 91% confidence intervals (CIs) of the geometric mean ratios (GMRs) for the primary end point of AUC 0-∞, entire course  were within the bioequivalence limits of 80-125% for all comparisons: DRL_RI versus RTX-US 100.37% (92.30-109.14), DRL_RI versus RTX-EU 93.58% (85.98-101.85), and RTX-US versus RTX-EU 93.24% (85.62-101.54).","[{'ForeName': 'Vikram Muralidhar', 'Initials': 'VM', 'LastName': 'Haridas', 'Affiliation': 'Sushruta Multispeciality Hospital, Hubballi, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Katta', 'Affiliation': 'Katta Hospital, S.R. Kalla Memorial General Hospital, Jaipur, India.'}, {'ForeName': 'Ajit', 'Initials': 'A', 'LastName': 'Nalawade', 'Affiliation': 'Inamdar Multispecialty Hospital, Pune, India.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Kharkar', 'Affiliation': 'Govt Medical College and Hospital, Medical Square, Nagpur, India.'}, {'ForeName': 'Vyacheslav', 'Initials': 'V', 'LastName': 'Zhdan', 'Affiliation': 'M.V.Sklifosovskyi Poltava Regional Hospital, Poltava, Ukraine.'}, {'ForeName': 'Olena', 'Initials': 'O', 'LastName': 'Garmish', 'Affiliation': 'SI NSC M.D. Strazhesko Institute of Cardiology, NAMS of Ukraine, Kiev, Ukraine.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Lopez-Lazaro', 'Affiliation': ""Clinical Sciences, Dr. Reddy's Laboratories Ltd., Elisabethenanlage 11, 4051, Basel, Switzerland. llopezlazaro@drreddys.com.""}, {'ForeName': 'Sonica Sachdeva', 'Initials': 'SS', 'LastName': 'Batra', 'Affiliation': ""Medical Sciences, Dr. Reddy's Laboratories Ltd., Bachupally, Hyderabad, 500090, India.""}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Kankanwadi', 'Affiliation': ""Development, Biologics, Dr. Reddy's Laboratories Ltd., Elisabethenanlage 11, 4051, Basel, Switzerland.""}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-020-00406-1']
528,32109729,Low-cost self-paced interventions increase birth satisfaction in first time fathers.,"OBJECTIVE


This research aims to investigate whether a skills or birth stories intervention for fathers can improve birth satisfaction of fathers.
STUDY DESIGN


One hundred and seventy-four men were recruited and randomly assigned to a skills preparation group, a birth stories group, or a treatment as usual (TAU) group. One hundred sixteen men completed the three questionnaires relevant for this report (67% retention rate). Birth satisfaction was measured soon after birth.
MEASURES


Demographic data and data related to partners pregnancy, birth and preparation were collected. The Mackey Childbirth Satisfaction Rating Scale was the primary outcome measure.
RESULTS


It was found that men who received either of the birth preparation interventions (skills or birth stories booklet) had significantly higher birth satisfaction scores. An analysis found that, irrespective of intervention, his partner having an induction, a caesarean section, and his not being in full-time employment had a negative effect on birth satisfaction, while his partner having an epidural, his experiencing family life satisfaction before the birth, his finding antenatal classes useful, and having his birth delivery expectations met had a positive impact on birth satisfaction.
CONCLUSION


Increasing the father's understanding, role expectations, and preparation for his partner's childbirth, may be important for fathers birth satisfaction. Expectations around childbirth and expectations of himself might be better managed to improve satisfaction. This study found evidence that simple low-cost interventions can improve birth satisfaction for new fathers.",2020,"An analysis found that, irrespective of intervention, his partner having an induction, a caesarean section, and his not being in full-time employment had a negative effect on birth satisfaction, while his partner having an epidural, his experiencing family life satisfaction before the birth, his finding antenatal classes useful, and having his birth delivery expectations met had a positive impact on birth satisfaction.
","['One hundred sixteen men completed the three questionnaires relevant for this report (67% retention rate', 'One hundred and seventy-four men', 'first time fathers', 'fathers', 'new fathers']","['skills preparation group, a birth stories group, or a treatment as usual (TAU', 'Low-cost self-paced interventions', 'birth stories intervention']","['birth satisfaction scores', 'Birth satisfaction', 'Mackey Childbirth Satisfaction Rating Scale', 'birth satisfaction']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015671', 'cui_str': 'Fathers'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C0222045'}]",174.0,0.0625908,"An analysis found that, irrespective of intervention, his partner having an induction, a caesarean section, and his not being in full-time employment had a negative effect on birth satisfaction, while his partner having an epidural, his experiencing family life satisfaction before the birth, his finding antenatal classes useful, and having his birth delivery expectations met had a positive impact on birth satisfaction.
","[{'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Howarth', 'Affiliation': 'Dunedin School of Medicine, Department of Psychological Medicine, Dunedin, New Zealand.'}, {'ForeName': 'Nicola R', 'Initials': 'NR', 'LastName': 'Swain', 'Affiliation': 'Dunedin School of Medicine, Department of Psychological Medicine, Dunedin, New Zealand. Electronic address: nicola.swain@otago.ac.nz.'}]",Sexual & reproductive healthcare : official journal of the Swedish Association of Midwives,['10.1016/j.srhc.2020.100503']
529,31026056,Exposure to mild intermittent hypoxia increases loop gain and the arousal threshold in participants with obstructive sleep apnoea.,"KEY POINTS


Repeated daily mild intermittent hypoxia has been endorsed as a therapy to promote the recovery of respiratory and limb motor dysfunction. One possible side-effect of this therapy is an increase in apnoeic event number and duration, which is particularly relevant to participants with motor disorders coupled with an increased incidence of sleep apnoea. In this study, we report that increases in apnoeic event number and duration, following exposure to daily intermittent hypoxia, are the result of an increase in respiratory loop gain and the arousal threshold, in participants with obstructive sleep apnoea. Daily exposure to mild intermittent hypoxia also led to an increase in the ventilatory response to arousal. Accordingly, individuals with motor disorders receiving mild intermittent hypoxia as a therapy should be screened for the presence of sleep apnoea, and if present, administration of intermittent hypoxia during hours of wakefulness should be combined with continuous positive airway pressure treatment during sleep.
ABSTRACT


We determined if exposure to mild intermittent hypoxia (MIH) causes an increase in loop gain (LG) and the arousal threshold (AT) during non-rapid eye movement (NREM) sleep. Male participants with obstructive sleep apnoea (apnoea-hypopnoea index > 5 events/h), matched for age, body mass index and race were divided into two groups (n = 13 in each group). Following a baseline sleep study, one group was exposed to twelve 4-min episodes of hypoxia each day for 10 days and the other group to a sham protocol (SP). On Days 1 and 10, a sleep study was completed following exposure to MIH or the SP. For each sleep study, LG and the AT were measured during NREM sleep, using a model-based approach, and expressed as a fraction of baseline measures. LG increased after exposure to MIH (Day 1: 1.11 ± 0.03, P = 0.002, Day 10: 1.17 ± 0.05, P = 0.001), but not after the SP (Day 1: 1.03 ± 0.04, P = 1.0, Day 10: 1.0 ± 0.02, P = 1.0). AT also increased after exposure to MIH (Day 1: 1.13 ± 0.05, P = 0.01, Day 10: 1.19 ± 0.08, P = 0.05) but not after the SP (Day 1: 1.04 ± 0.05, P = 0.6, Day 10: 0.96 ± 0.04, P = 1.0). Our results might account for increases in apnoea frequency and duration previously observed during NREM sleep following exposure to MIH. Our results also have implications for the use of MIH as a therapeutic modality.",2019,"AT also increased after exposure to MIH (Day 1: 1.13 ± 0.05, P = 0.01, Day 10: 1.19 ± 0.08, P = 0.05) but not after the SP (Day 1: 1.04 ± 0.05, P = 0.6, Day 10: 0.96 ± 0.04, P = 1.0).","['participants with motor disorders', 'individuals with motor disorders receiving mild intermittent hypoxia', 'Male participants with obstructive sleep apnoea (apnoea-hypopnoea index >\xa05\xa0events/h), matched for age, body mass index and race', 'participants with obstructive sleep apnoea']",[],"['LG', 'ventilatory response to arousal']","[{'cui': 'C0221163', 'cui_str': 'Motor Disorders'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}]",[],"[{'cui': 'C0003808', 'cui_str': 'Arousal'}]",,0.0436555,"AT also increased after exposure to MIH (Day 1: 1.13 ± 0.05, P = 0.01, Day 10: 1.19 ± 0.08, P = 0.05) but not after the SP (Day 1: 1.04 ± 0.05, P = 0.6, Day 10: 0.96 ± 0.04, P = 1.0).","[{'ForeName': 'Raichel M', 'Initials': 'RM', 'LastName': 'Alex', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center, Detroit, MI, 48201, USA.'}, {'ForeName': 'Gino S', 'Initials': 'GS', 'LastName': 'Panza', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center, Detroit, MI, 48201, USA.'}, {'ForeName': 'Huzaifa', 'Initials': 'H', 'LastName': 'Hakim', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center, Detroit, MI, 48201, USA.'}, {'ForeName': 'M Safwan', 'Initials': 'MS', 'LastName': 'Badr', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center, Detroit, MI, 48201, USA.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Edwards', 'Affiliation': 'Sleep and Circadian Medicine Laboratory, Department of Physiology Monash University, Melbourne, Australia.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Sands', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Jason H', 'Initials': 'JH', 'LastName': 'Mateika', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center, Detroit, MI, 48201, USA.'}]",The Journal of physiology,['10.1113/JP277711']
530,32245745,Long term skeletal and dental changes between tooth-anchored versus Dresden bone-anchored rapid maxillary expansion using CBCT images in adolescents: Randomized clinical trial.,"OBJECTIVE


The aim of this study was to determine long-term skeletal and dental changes in tooth-anchored versus Dresden bone-anchored rapid maxillary expansion using CBCT images in adolescents.
MATERIALS AND METHODS


In all, 29 adolescent patients (11-17 years of age) needing skeletal expansion were randomly allocated to two different groups treated by either a Dresden bone-anchored expander or a conventional hyrax expander. Patients included did not have previous orthodontic treatment, were non-syndromic and had all teeth present in mouth. CBCT images were taken before expansion and two or more years after expansion. An independent T-test was used to determine the statistical significance between treatment groups and paired T-test was used to compare the results before and after expansion in each group.
RESULTS


Neither treatment group showed overall long-term different skeletal and dental changes in the transverse, anterior-posterior and vertical planes (P<0.05). Both treatment groups showed mild asymmetric skeletal expansion, but these were clinically insignificant.
CONCLUSIONS


Both expanders had similar skeletal and dental results. The greatest changes were in the transverse plane. Changes in vertical and anterior-posterior were negligible.",2020,"Neither treatment group showed overall long-term different skeletal and dental changes in the transverse, anterior-posterior and vertical planes (P<0.05).","['29 adolescent patients (11-17 years of age) needing skeletal expansion', 'adolescents', 'Patients included did not have previous orthodontic treatment, were non-syndromic and had all teeth present in mouth']",['Dresden bone-anchored expander or a conventional hyrax expander'],"['overall long-term different skeletal and dental changes', 'mild asymmetric skeletal expansion']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0457755', 'cui_str': 'Tooth presence - finding'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C1720978', 'cui_str': 'Bone Anchors'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0020696', 'cui_str': 'Family Procaviidae'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}]",29.0,0.0890528,"Neither treatment group showed overall long-term different skeletal and dental changes in the transverse, anterior-posterior and vertical planes (P<0.05).","[{'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Davami', 'Affiliation': 'Private Practice, Isfahan, Iran.'}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Talma', 'Affiliation': 'University of Minas Gerais, Structural Engineering School, Minas Gerais, Brazil.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Harzer', 'Affiliation': 'Technical University of Dresden, department of Orthodontics, Fetscherstr. 72, D-01307 Dresden, Germany.'}, {'ForeName': 'Manuel O', 'Initials': 'MO', 'LastName': 'Lagravère', 'Affiliation': 'University of Alberta, Faculty of Medicine and Dentistry, School of Dentistry, Orthodontic Graduate Program, ECHA 5-524, 11405-87 Ave, T6G 1C9 Edmonton, AB, Canada. Electronic address: manuel@ualberta.ca.'}]",International orthodontics,['10.1016/j.ortho.2020.02.004']
531,32176703,"The safety of combined triple drug therapy with ivermectin, diethylcarbamazine and albendazole in the neglected tropical diseases co-endemic setting of Fiji: A cluster randomised trial.","Lymphatic filariasis has remained endemic in Fiji despite repeated mass drug administration using the well-established and safe combination of diethylcarbamazine and albendazole (DA) since 2002. In certain settings the addition of ivermectin to this combination (IDA) remains a safe strategy and is more efficacious. However, the safety has yet to be described in scabies and soil-transmitted helminth endemic settings like Fiji. Villages of Rotuma and Gau islands were randomised to either DA or IDA. Residents received weight-based treatment unblinded with standard exclusions. Participants were actively found and asked by a nurse about their health daily for the first two days and then asked to seek review for the next five days if unwell. Anyone with severe symptoms were reviewed by a doctor and any serious adverse event was reported to the Medical Monitor and Data Safety Monitoring Board. Of 3612 enrolled and eligible participants, 1216 were randomised to DA and 2396 to IDA. Age and sex in both groups were representative of the population. Over 99% (3598) of participants completed 7 days follow-up. Adverse events were reported by 600 participants (16.7%), distributed equally between treatment groups, with most graded as mild (93.2%). There were three serious adverse events, all judged not attributable to treatment by an independent medical monitor. Fatigue was the most common symptom reported by 8.5%, with headache, dizziness, nausea and arthralgia being the next four most common symptoms. Adverse events were more likely in participants with microfilaremia (43.2% versus 15.7%), but adverse event frequency was not related to the presence of scabies or soil-transmitted helminth infection. IDA has comparable safety to DA with the same frequency of adverse events experienced following community mass drug administration. The presence of co-endemic infections did not increase adverse events. IDA can be used in community programs where preventative chemotherapy is needed for control of lymphatic filariasis and other neglected tropical diseases.",2020,"Adverse events were more likely in participants with microfilaremia (43.2% versus 15.7%), but adverse event frequency was not related to the presence of scabies or soil-transmitted helminth infection.","['Of 3612 enrolled and eligible participants, 1216 were randomised to DA and 2396 to IDA', 'Villages of Rotuma and Gau islands', 'neglected tropical diseases co-endemic setting of Fiji']","['diethylcarbamazine and albendazole', 'DA or IDA', 'IDA', 'ivermectin, diethylcarbamazine and albendazole', 'ivermectin']","['headache, dizziness, nausea and arthralgia', 'adverse events', 'Adverse events', 'Fatigue', 'serious adverse events']","[{'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0022130', 'cui_str': 'Islands'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0016080', 'cui_str': 'Fiji'}]","[{'cui': 'C0012191', 'cui_str': 'Diethylcarbamazine'}, {'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",3612.0,0.120301,"Adverse events were more likely in participants with microfilaremia (43.2% versus 15.7%), but adverse event frequency was not related to the presence of scabies or soil-transmitted helminth infection.","[{'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'Hardy', 'Affiliation': ""Tropical Diseases Research Group, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Josaia', 'Initials': 'J', 'LastName': 'Samuela', 'Affiliation': 'Fiji Ministry of Health and Medical Services, Suva, Fiji.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Kama', 'Affiliation': 'Fiji Ministry of Health and Medical Services, Suva, Fiji.'}, {'ForeName': 'Meciusela', 'Initials': 'M', 'LastName': 'Tuicakau', 'Affiliation': 'Fiji Ministry of Health and Medical Services, Suva, Fiji.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Romani', 'Affiliation': 'Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Margot J', 'Initials': 'MJ', 'LastName': 'Whitfeld', 'Affiliation': ""St Vincent's Hospital, University of New South Wales, Sydney, New South Wales, Australia.""}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'King', 'Affiliation': 'Centre for Global Health and Diseases, Case Western Reserve University, Cleveland, Ohio, United States of America.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Weil', 'Affiliation': 'Washington University, St. Louis, Missouri, United States of America.'}, {'ForeName': 'Anneke C', 'Initials': 'AC', 'LastName': 'Grobler', 'Affiliation': ""Tropical Diseases Research Group, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Leanne J', 'Initials': 'LJ', 'LastName': 'Robinson', 'Affiliation': 'Vector-borne Diseases and Tropical Public Health, Burnet Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kaldor', 'Affiliation': 'Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Steer', 'Affiliation': ""Tropical Diseases Research Group, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008106']
532,32092321,"A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Pulsed, Inhaled Nitric Oxide at a Dose of 30 μg/kg Ideal Body Weight/hr in Subjects at Risk of Pulmonary Hypertension Associated With Pulmonary Fibrosis Receiving Oxygen Therapy.","BACKGROUND


The interstitial lung diseases include a variety of disorders, many of which are characterized by fibrotic changes (fILD). Of the fILDs, Idiopathic pulmonary fibrosis is the most common. Pulmonary hypertension (PH) frequently complicates fILD and is associated with impaired functional capability, lower physical activity, and significantly reduced life expectancy. There is no proven treatment for patients with fILD-PH. We report results from the first cohort of a phase 2b/3 trial with pulsed inhaled nitric oxide (iNO) in patients with fILD-PH.
METHODS


Subjects in cohort 1 were randomized to iNO 30 μg/kg ideal body weight/hr (iNO30) or placebo for 8 weeks of blinded treatment; subjects then transitioned to open-label extension (OLE) on iNO30 followed by dose escalation to iNO45 then iNO75. Activity monitoring was used to assess changes in daily activity. Safety and efficacy were evaluated.
RESULTS


Twenty-three patients were randomized to iNO30 and 18 to placebo. During blinded treatment, iNO30 subjects showed an average improvement in moderate/vigorous physical activity (MVPA) and remained stable in overall activity. Placebo subjects showed an average drop of 26% in MVPA and a 12% drop in overall activity. The iNO group had an improvement in oxygen saturation. During OLE, subjects maintained their activity levels including placebo subjects who transitioned from a decline to a maintenance in all activity parameters. Inhaled nitric oxide at all doses (30, 45, and 75) was safe and well tolerated.
CONCLUSIONS


Treatment with iNO30 demonstrated clinically and statistically significant benefit in MVPA and clinically significant benefit in overall activity. In the OLE, higher doses of iNO were also safe and well tolerated while showing maintenance in activity parameters.",2020,During blinded treatment iNO30 subjects showed an average improvement in moderate/vigorous physical activity (MVPA) and remained stable in overall activity.,"['subjects at risk of Pulmonary Hypertension associated with Pulmonary Fibrosis (PH-PF) receiving Oxygen Therapy', 'patients with fILD-PH', 'patients with fILD-PH.\nMETHODS\n\n\nSubjects in Cohort 1']","['iNO 30 mcg/kg IBW/hr (iNO30) or placebo', 'placebo', 'pulsed, inhaled nitric oxide (iNO', 'pulsed iNO', 'Placebo']","['safety and efficacy', 'overall activity', 'activity levels', 'Safety and efficacy', 'oxygen saturation', 'safe and well tolerated', 'moderate/vigorous physical activity (MVPA']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0034069', 'cui_str': 'Pulmonary Fibrosis'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1627892', 'cui_str': 'ng/g'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",23.0,0.139946,During blinded treatment iNO30 subjects showed an average improvement in moderate/vigorous physical activity (MVPA) and remained stable in overall activity.,"[{'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Nathan', 'Affiliation': 'Advanced Lung Disease and Transplant Program, Inova Heart and Vascular Institute, Inova Fairfax Hospital, Richmond, VA; Virginia Commonwealth University, Richmond, VA. Electronic address: steven.nathan@inova.org.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Flaherty', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Marilyn K', 'Initials': 'MK', 'LastName': 'Glassberg', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Raghu', 'Affiliation': 'the University of Arizona College of Medicine - Phoenix and Banner; University of Washington Medical Center, Seattle, WA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Swigris', 'Affiliation': 'Department of Medicine, National Jewish, Denver, CO.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Alvarez', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Ettinger', 'Affiliation': 'The Lung Research Center-Missouri, Chesterfield, MO.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Loyd', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fernandes', 'Affiliation': 'Bellerophon Therapeutics, Warren, NJ.'}, {'ForeName': 'Hunter', 'Initials': 'H', 'LastName': 'Gillies', 'Affiliation': 'Bellerophon Therapeutics, Warren, NJ.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Bellerophon Therapeutics, Warren, NJ.'}, {'ForeName': 'Parag', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Bellerophon Therapeutics, Warren, NJ.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Lancaster', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}]",Chest,['10.1016/j.chest.2020.02.016']
533,31097732,Complexity-Based Measures of Heart Rate Dynamics in Older Adults Following Long- and Short-Term Tai Chi Training: Cross-sectional and Randomized Trial Studies.,"Measures characterizing the complexity of heart rate (HR) dynamics have been informative in predicting age- and disease-related decline in cardiovascular health, but few studies have evaluated whether mind-body exercise can impact HR complexity. This study evaluated the effects of long-term Tai Chi (TC) practice on the complexity of HR dynamics using an observational comparison of TC experts and age- and gender-matched TC-naïve individuals. Shorter-term effects of TC were assessed by randomly assigning TC-naïve participants to either TC group to receive six months of TC training or to a waitlist control group. 23 TC experts (age = 63.3 ± 8.0 y; 24.6 ± 12.0 y TC experience) and 52 TC-naïve (age = 64.3 ± 7.7 y) were enrolled. In cross-sectional analyses, TC experts had a higher overall complexity index (CI, p = 0.004) and higher entropy at multiple individual time scales (p < 0.05); these findings persisted in models accounting for age, gender, body mass index (BMI), and physical activity levels. Longitudinal changes in complexity index did not differ significantly following random assignment to six months of TC vs. a waitlist control; however, within the TC group, complexity at select time scales showed statistically non-significant trends toward increases. Our study supports that longer-term TC mind-body training may be associated with increased complexity of HR dynamics.",2019,"In cross-sectional analyses, TC experts had a higher overall complexity index (CI, p = 0.004) and higher entropy at multiple individual time scales (p < 0.05); these findings persisted in models accounting for age, gender, body mass index (BMI), and physical activity levels.","['23 TC experts (age\u2009=\u200963.3\u2009±\u20098.0\u2009y; 24.6\u2009±\u200912.0\u2009y TC experience) and 52 TC-naïve (age\u2009=\u200964.3\u2009±\u20097.7\u2009y) were enrolled', 'Older Adults', 'TC experts and age- and gender-matched TC-naïve individuals']","['TC', 'TC training', 'long-term Tai Chi (TC) practice']","['complexity of heart rate (HR) dynamics', 'overall complexity index', 'body mass index (BMI), and physical activity levels', 'complexity index']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517860', 'cui_str': '7.7 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0148747,"In cross-sectional analyses, TC experts had a higher overall complexity index (CI, p = 0.004) and higher entropy at multiple individual time scales (p < 0.05); these findings persisted in models accounting for age, gender, body mass index (BMI), and physical activity levels.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Division of Interdisciplinary Medicine and Biotechnology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States. dr.yan.ma@gmail.com.'}, {'ForeName': 'Chiu-Wen', 'Initials': 'CW', 'LastName': 'Wu', 'Affiliation': 'National Taiwan Normal University, Department of Mechatronic Engineering, Taipei, Taiwan.'}, {'ForeName': 'Chung-Kang', 'Initials': 'CK', 'LastName': 'Peng', 'Affiliation': 'Division of Interdisciplinary Medicine and Biotechnology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ahn', 'Affiliation': 'Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Bertisch', 'Affiliation': 'Department of Pulmonary, Critical Care, and Sleep Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Lewis A', 'Initials': 'LA', 'LastName': 'Lipsitz', 'Affiliation': 'Division of Gerontology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Gloria Y', 'Initials': 'GY', 'LastName': 'Yeh', 'Affiliation': 'Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Manor', 'Affiliation': 'Division of Gerontology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Novak', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Hausdorff', 'Affiliation': 'Center for the Study of Movement, Cognition, and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Gow', 'Affiliation': 'Division of Interdisciplinary Medicine and Biotechnology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': ""Osher Center for Integrative Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.""}]",Scientific reports,['10.1038/s41598-019-43602-y']
534,32240532,Is Protocolised Weaning that Includes Early Extubation Onto Non-Invasive Ventilation More Cost Effective Than Protocolised Weaning Without Non-Invasive Ventilation? Findings from the Breathe Study.,"BACKGROUND


Optimising techniques to wean patients from invasive mechanical ventilation (IMV) remains a key goal of intensive care practice. The use of non-invasive ventilation (NIV) as a weaning strategy (transitioning patients who are difficult to wean to early NIV) may reduce mortality, ventilator-associated pneumonia and intensive care unit (ICU) length of stay.
OBJECTIVES


Our objectives were to determine the cost effectiveness of protocolised weaning, including early extubation onto NIV, compared with weaning without NIV in a UK National Health Service setting.
METHODS


We conducted an economic evaluation alongside a multicentre randomised controlled trial. Patients were randomised to either protocol-directed weaning from mechanical ventilation or ongoing IMV with daily spontaneous breathing trials. The primary efficacy outcome was time to liberation from ventilation. Bivariate regression of costs and quality-adjusted life-years (QALYs) provided estimates of the incremental cost per QALY and incremental net monetary benefit (INMB) overall and for subgroups [presence/absence of chronic obstructive pulmonary disease (COPD) and operative status]. Long-term cost effectiveness was determined through extrapolation of survival curves using flexible parametric modelling.
RESULTS


NIV was associated with a mean INMB of £620 ($US885) (cost-effectiveness threshold of £20,000 per QALY) with a corresponding probability of 58% that NIV is cost effective. The probability that NIV is cost effective was higher for those with COPD (84%). NIV was cost effective over 5 years, with an estimated incremental cost-effectiveness ratio of £4618 ($US6594 per QALY gained).
CONCLUSIONS


The probability of NIV being cost effective relative to weaning without NIV ranged between 57 and 59% overall and between 82 and 87% for the COPD subgroup.",2020,"NIV was cost effective over 5 years, with an estimated incremental cost-effectiveness ratio of £4618 ($US6594 per QALY gained).
",['wean patients from invasive mechanical ventilation (IMV'],"['Protocolised Weaning Without Non-Invasive Ventilation', 'protocol-directed weaning from mechanical ventilation or ongoing IMV with daily spontaneous breathing trials', 'non-invasive ventilation (NIV', 'Invasive Ventilation']","['Bivariate regression of costs and quality-adjusted life-years (QALYs) provided estimates of the incremental cost per QALY and incremental net monetary benefit (INMB) overall and for subgroups [presence/absence of chronic obstructive pulmonary disease (COPD) and operative status', 'mean INMB', 'cost effective', 'time to liberation from ventilation']","[{'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}]","[{'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1828139', 'cui_str': 'Trial for spontaneous breathing'}, {'cui': 'C0751673', 'cui_str': 'Nipah virus'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]",,0.203286,"NIV was cost effective over 5 years, with an estimated incremental cost-effectiveness ratio of £4618 ($US6594 per QALY gained).
","[{'ForeName': 'Iftekhar', 'Initials': 'I', 'LastName': 'Khan', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK. i.khan.2@warwick.ac.uk.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Maredza', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Dritsaki', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, OX3 9DU, UK.'}, {'ForeName': 'Dipesh', 'Initials': 'D', 'LastName': 'Mistry', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Lall', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Couper', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gates', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Petrou', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PharmacoEconomics - open,['10.1007/s41669-020-00210-1']
535,32240761,Ticagrelor With or Without Aspirin After Complex PCI.,"BACKGROUND


Whether a regimen of ticagrelor monotherapy attenuates bleeding complications without increasing ischemic risk in patients undergoing complex percutaneous coronary intervention (PCI) is unknown.
OBJECTIVES


The purpose of this study was to evaluate the effect of ticagrelor monotherapy versus ticagrelor plus aspirin in patients undergoing complex PCI from the randomized, double-blind, placebo-controlled TWILIGHT (Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention) trial.
METHODS


In the TWILIGHT trial, after 3 months of ticagrelor plus aspirin, event-free and adherent patients remained on ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. Complex PCI was defined as any of the following: 3 vessels treated, ≥3 lesions treated, total stent length >60 mm, bifurcation with 2 stents implanted, atherectomy device use, left main PCI, surgical bypass graft or chronic total occlusion as target lesions. Bleeding and ischemic endpoints were evaluated at 1 year after randomization.
RESULTS


Among 7,119 patients randomized in the main trial, complex PCI was performed in 2,342 patients. Compared to ticagrelor plus aspirin, ticagrelor plus placebo resulted in significantly lower rates of Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding (4.2% vs. 7.7%; hazard ratio [HR]: 0.54; 95% confidence interval [CI]: 0.38 to 0.76). BARC type 3 or 5 bleeding was also significantly reduced (1.1% vs. 2.6%; HR: 0.41; 95% CI: 0.21 to 0.80). There were no significant between-group differences in death, myocardial infarction, or stroke (3.8% vs. 4.9%; HR: 0.77; 95% CI: 0.52 to 1.15), nor in stent thrombosis.
CONCLUSIONS


Among patients undergoing complex PCI who initially completed 3 months of ticagrelor plus aspirin, continuation of ticagrelor monotherapy was associated with lower incidence of bleeding without increasing the risk of ischemic events compared to continuing ticagrelor plus aspirin. (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention [TWILIGHT]; NCT02270242).",2020,"Compared to ticagrelor plus aspirin, ticagrelor plus placebo resulted in significantly lower rates of BARC type 2, 3 or 5 bleeding (4.2% vs. 7.7%; hazard ratio [HR]: 0.54; 95% confidence interval [CI]: 0.38-0.76).","['patients undergoing complex PCI', '7,119 patients randomized in the main trial, complex PCI was performed in 2,342 patients', 'patients undergoing complex percutaneous coronary intervention (PCI']","['ticagrelor plus aspirin', 'ticagrelor plus aspirin, ticagrelor plus placebo', 'Ticagrelor With Aspirin or Alone', 'aspirin or placebo', 'ticagrelor monotherapy versus ticagrelor plus aspirin', 'placebo', 'ticagrelor monotherapy']","['BARC type 3 or 5 bleeding', 'death, myocardial infarction or stroke', 'Bleeding and ischemic endpoints', 'risk of ischemic events', 'stent thrombosis', 'rates of BARC type 2, 3 or 5 bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]",7119.0,0.615514,"Compared to ticagrelor plus aspirin, ticagrelor plus placebo resulted in significantly lower rates of BARC type 2, 3 or 5 bleeding (4.2% vs. 7.7%; hazard ratio [HR]: 0.54; 95% confidence interval [CI]: 0.38-0.76).","[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dangas', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Baber', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Samin', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Giustino', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Shamir', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'University of Missouri-Kansas City, Kansas City, Missouri.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Sartori', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Chandiramani', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Briguori', 'Affiliation': 'Mediterranea Cardiocentro, Naples, Italy.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Dudek', 'Affiliation': 'Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland; Maria Cecilia Hospital, GVM Care & Research, Cotignola (RA), Italy.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clínico San Carlos IDISCC, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': '3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminen Hospital, and Sigmund Freud University, Medical Faculty, Vienna, Austria.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Collier', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Kornowski', 'Affiliation': 'Cardiology Department, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Kunadian', 'Affiliation': 'Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University and Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Upendra', 'Initials': 'U', 'LastName': 'Kaul', 'Affiliation': 'Batra Hospital and Medical Research Center, New Delhi, India.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Oldroyd', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Sardella', 'Affiliation': 'Department of Cardiology, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Shlofmitz', 'Affiliation': 'St. Francis Hospital, Roslyn, New York.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Witzenbichler', 'Affiliation': 'Department of Cardiology and Pneumology, Helios Amper-Klinikum, Dachau, Germany.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Ya-Ling', 'Affiliation': 'Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, Liaoning, China.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Pocock', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: roxana.mehran@mountsinai.org.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.03.011']
536,32236533,Effect of Intensivist Communication in a Simulated Setting on Interpretation of Prognosis Among Family Members of Patients at High Risk of Intensive Care Unit Admission: A Randomized Trial.,"Importance


Discordance about prognosis between a patient's health care decision-making surrogate and the treating intensivist is common in the intensive care unit (ICU). Empowering families, friends, and caregivers of patients who are critically ill to make informed decisions about care is important, but it is unclear how best to communicate prognostic information to surrogates when a patient is expected to die.
Objective


To determine whether family members, who are often health care decision-making surrogates, interpret intensivists as being more optimistic when questions about prognosis in the ICU are answered indirectly.
Design, Setting, and Participants


This web-based randomized trial was conducted between September 27, 2019, and October 17, 2019, among a national sample of adult children, spouses, partners, or siblings of people with chronic obstructive pulmonary disease who were receiving long-term oxygen therapy. Participants were shown video vignettes depicting an intensivist answering a standardized question about the prognosis of a patient at high risk of death on day 3 of ICU admission. Participants were excluded if they had worked as a physician, nurse, or advanced health care practitioner. Data were analyzed from October 18, 2019, to November 12, 2019.
Interventions


Participants were randomized to view 1 of 4 intensivist communication styles in response to the question ""What do you think is most likely to happen?"": (1) a direct response (control), (2) an indirect response comparing the patient's condition with that of other patients, (3) an indirect response describing the patient's deteriorating physiological condition, or (4) redirection to a discussion of the patient's values and goals.
Main Outcomes and Measures


Participant responses to 2 questions: (1) ""If you had to guess, what do you think the doctor thinks is the chance that your loved one will survive this hospitalization?"" and (2) ""What do you think are the chances that your loved one will survive this hospitalization?"" answered using a 0% to 100% probability scale.
Results


Among 302 participants (median [interquartile range] age, 49 [38-59] years; 204 [68%] women) included in the trial, 165 (55%) were adult children of the individual with chronic obstructive pulmonary disease; 77 participants were randomized to view a direct response, 77 participants were randomized to view an indirect response referencing other patients, 68 participants were randomized to view an indirect response referencing physiological condition, and 80 participants were randomized to view a redirection response. Compared with participants who viewed a direct response, participants who viewed an indirect response referencing other patients (β = 10 [95% CI, 1-19]; P = .03), physiological condition (β = 10 [95% CI, 0-19]; P = .04), or redirection to a discussion of the patient's values and goals (β = 19 [95% CI, 10-28]; P < .001) perceived the intensivist to have a significantly more optimistic prognostic estimate.
Conclusions and Relevance


These findings suggest that family members interpret indirect or redirection responses to questions about prognosis in the ICU setting as more optimistic than direct responses.
Trial Registration


ClinicalTrials.gov Identifier: NCT04239209.",2020,"Compared with participants who viewed a direct response, participants who viewed an indirect response referencing other patients (β = 10 [95% CI, 1-19]; P = .03), physiological condition (β = 10 [95% CI, 0-19]; P = .04), or redirection to a discussion of the patient's values and goals (β = 19 [95% CI, 10-28]; P < .001) perceived the intensivist to have a significantly more optimistic prognostic estimate.
","['Participants were excluded if they had worked as a physician, nurse, or advanced health care practitioner', 'Participants\n\n\nThis web-based randomized trial was conducted between September 27, 2019, and October 17, 2019, among a national sample of adult children, spouses, partners, or siblings of people with chronic obstructive pulmonary disease who were receiving long-term oxygen therapy', 'Family Members of Patients at High Risk of Intensive Care Unit Admission', '302 participants (median [interquartile range] age, 49 [38-59] years; 204 [68%] women) included in the trial, 165 (55%) were adult children of the individual with chronic obstructive pulmonary disease; 77 participants were randomized to view a direct response, 77 participants were randomized to view an indirect response referencing other patients, 68 participants were randomized to view an indirect response referencing physiological condition, and 80 participants']","['Intensivist Communication', ""indirect response describing the patient's deteriorating physiological condition, or (4) redirection to a discussion of the patient's values and goals""]","['optimistic prognostic estimate', 'Main Outcomes and Measures\n\n\nParticipant responses to 2 questions: (1) ']","[{'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0683572', 'cui_str': 'Children, Adult'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0418996', 'cui_str': 'Long-term oxygen therapy'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]","[{'cui': 'C0564470', 'cui_str': 'Optimistic'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",165.0,0.20929,"Compared with participants who viewed a direct response, participants who viewed an indirect response referencing other patients (β = 10 [95% CI, 1-19]; P = .03), physiological condition (β = 10 [95% CI, 0-19]; P = .04), or redirection to a discussion of the patient's values and goals (β = 19 [95% CI, 10-28]; P < .001) perceived the intensivist to have a significantly more optimistic prognostic estimate.
","[{'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Oppenheim', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Emma M', 'Initials': 'EM', 'LastName': 'Lee', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Vasher', 'Affiliation': 'Department of Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Zaeh', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Joanna L', 'Initials': 'JL', 'LastName': 'Hart', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Alison E', 'Initials': 'AE', 'LastName': 'Turnbull', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.1945']
537,32245569,"Intravenous sildenafil citrate and post-cardiac surgery acute kidney injury: a double-blind, randomised, placebo-controlled trial.","BACKGROUND


This study assessed whether i.v. sildenafil citrate prevented acute kidney injury in at-risk patients undergoing cardiac surgery with cardiopulmonary bypass.
METHODS


In a double-blind RCT, adults at increased risk of acute kidney injury undergoing cardiac surgery in a single UK tertiary centre were randomised to receive sildenafil citrate 12.5 mg kg -1  i.v. over 150 min or dextrose 5% at the commencement of surgery. The primary outcome was serum creatinine measured at six post-randomisation time points. The primary analysis used a linear mixed-effects model adjusted for the stratification variables, baseline estimated glomerular filtration rate, and surgical procedure. Secondary outcomes considered clinical events and potential disease mechanisms. Effect estimates were expressed as mean differences (MDs) or odds ratios with 95% confidence intervals.
RESULTS


The analysis population comprised eligible randomised patients that underwent valve surgery or combined coronary artery bypass graft and valve surgery, with cardiopulmonary bypass, between May 2015 and June 2018. There were 60 subjects in the sildenafil group and 69 in the placebo control group. The difference between groups in creatinine concentration was not statistically significant (MD: 0.88 μmol L -1  [-5.82, 7.59]). There was a statistically significant increase in multiple organ dysfunction scores in the sildenafil group (MD: 0.54 [0.02, 1.07]; P=0.044). Secondary outcomes, and biomarkers of kidney injury, endothelial function, and inflammatory cell activation, were not significantly different between the groups.
CONCLUSIONS


These results do not support the use of i.v. sildenafil citrate for kidney protection in adult cardiac surgery.
CLINICAL TRIAL REGISTRATION


ISRCTN18386427.",2020,"There was a statistically significant increase in multiple organ dysfunction scores in the sildenafil group (MD: 0.54 [0.02, 1.07]; P=0.044).","['60 subjects in the sildenafil group and 69 in the placebo control group', 'acute kidney injury undergoing cardiac surgery in a single UK tertiary centre', 'at-risk patients undergoing cardiac surgery with cardiopulmonary bypass', 'and post-cardiac surgery acute kidney injury']","['dextrose', 'placebo', 'valve surgery or combined coronary artery bypass graft and valve surgery, with cardiopulmonary bypass', 'Intravenous sildenafil citrate', 'sildenafil citrate', 'sildenafil']","['serum creatinine', 'clinical events and potential disease mechanisms', 'acute kidney injury', 'creatinine concentration', 'biomarkers of kidney injury, endothelial function, and inflammatory cell activation', 'glomerular filtration rate, and surgical procedure', 'multiple organ dysfunction scores']","[{'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0440752', 'cui_str': 'Inflammatory cell'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1960439', 'cui_str': 'Multiple organ dysfunction score'}]",,0.802905,"There was a statistically significant increase in multiple organ dysfunction scores in the sildenafil group (MD: 0.54 [0.02, 1.07]; P=0.044).","[{'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Kumar', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK.'}, {'ForeName': 'Hardeep', 'Initials': 'H', 'LastName': 'Aujla', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Woźniak', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK.'}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Dott', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK.'}, {'ForeName': 'Nikol', 'Initials': 'N', 'LastName': 'Sullo', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK; University of Nottingham, Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'Lathishia', 'Initials': 'L', 'LastName': 'Joel-David', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pais', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Smallwood', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK; School of Allied Health Sciences, De Montfort University, Leicester, UK.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Miller', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Eagle-Hemming', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK.'}, {'ForeName': 'Ana Suazo', 'Initials': 'AS', 'LastName': 'Di Paola', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, UK.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Barber', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, UK.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Brookes', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, UK.'}, {'ForeName': 'Nigel J', 'Initials': 'NJ', 'LastName': 'Brunskill', 'Affiliation': 'Department of Infection, Immunity and Inflammation, University of Leicester, Leicester, UK.'}, {'ForeName': 'Gavin J', 'Initials': 'GJ', 'LastName': 'Murphy', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK; Leicester Clinical Trials Unit, University of Leicester, Leicester, UK. Electronic address: gjm19@le.ac.uk.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.01.030']
538,31853772,Use of Rapid HIV Self-Test to Screen Potential Sexual Partners: Results of the ISUM Study.,"ISUM (""I'll show you mine"") was a randomized controlled trial in which 272 transgender women and men who have sex with men in New York, NY (NYC) and San Juan, Puerto Rico (SJU) were assigned to an intervention group (n = 136), in which they had access to free HIV self-testing (ST) kits, or to a control group (n = 136). The trial aimed to determine whether the intervention group would use ST to screen sexual partners and have fewer condomless anal intercourse (CAI) occasions with serodiscordant or unknown status partners than the control group. The intervention group had on average 10 (32%) fewer CAI occasions; though clinically relevant, this difference fell short of statistical significance (p = .08). In NYC (n = 166) intervention participants had significantly fewer CAI occasions, whereas in SJU (n = 106) they reported non-significantly more CAI occasions. Two devastating hurricanes hit SJU during the study and may have impacted results in unmeasured ways.",2020,"The intervention group had on average 10 (32%) fewer CAI occasions; though clinically relevant, this difference fell short of statistical significance (p = .08).","['Screen Potential Sexual Partners', 'to screen sexual partners and have fewer condomless anal intercourse (CAI) occasions with serodiscordant or unknown status partners than the control group', '272 transgender women and men who have sex with men in New York, NY (NYC) and San Juan, Puerto Rico (SJU']","['ST', 'ISUM (""I\'ll show you mine', 'Rapid HIV Self-Test']",['CAI occasions'],"[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0036911', 'cui_str': 'Sexual Partners'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration (finding)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",[],,0.0544861,"The intervention group had on average 10 (32%) fewer CAI occasions; though clinically relevant, this difference fell short of statistical significance (p = .08).","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Carballo-Diéguez', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA. ac72@cumc.columbia.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Giguere', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Iván C', 'Initials': 'IC', 'LastName': 'Balán', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Brown', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Dolezal', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Cheng-Shiun', 'Initials': 'CS', 'LastName': 'Leu', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lopez Rios', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Alan Z', 'Initials': 'AZ', 'LastName': 'Sheinfil', 'Affiliation': 'Department of Psychology, Syracuse University, Syracuse, NY, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Frasca', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Christine Tagliaferri', 'Initials': 'CT', 'LastName': 'Rael', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Lentz', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Raynier', 'Initials': 'R', 'LastName': 'Crespo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, PR, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Iribarren', 'Affiliation': 'Biobehavioral Nursing and Health Informatics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cruz Torres', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, PR, USA.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Febo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, PR, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02763-7']
539,32235946,The efficacy of vestibular rehabilitation in patients with chronic unilateral vestibular dysfunction.,"OBJECTIVES


Vestibular rehabilitation leads to a gradual diminution of the subjective and objective symptoms that accompany the vestibular disorders. The aim of the study was to compare the impact of 2 different types of vestibular rehabilitation on vestibular compensation in patients with chronic unilateral vestibular dysfunction.
MATERIAL AND METHODS


The study was conducted on a group of 58 subjects (43 females and 15 males) aged 40-64 years, who presented with chronic unilateral vestibular dysfunction and were hospitalized. The patients were randomly assigned to either of the 2 groups established. The study was conducted in a 6-week period. Group 1 consisted of patients who underwent customized group vestibular rehabilitation in an outpatient setting. The program was performed once a week for 1 h 30 min, under the supervision of a physiotherapist and a physiatrist. Group 2 was instructed to perform Cawthorne-Cooksey exercises and simple balance exercises twice a day for 15 min.
RESULTS


An improvement in the outcomes of the Dynamic Gait Index as well as the <i>Berg Balance Scale</i> was statistically significant for group 1. The time for fulfilling the task in the Timed Up and Go Test improved in both groups (p < 0.05). The subjective estimation of the symptoms evaluated with the use of the Dizziness Handicap Inventory and the <i>Visual Analogue Scale</i> revealed a statistically significant improvement in both groups, yet it was higher in group 1.
CONCLUSIONS


The compensation achieved after 6 weeks of the customized, supervised outpatient rehabilitation program in group 1 was superior to the results of the home-based unsupervised Cawthorne-Cooksey and balance exercises. Int J Occup Med Environ Health. 2020;33(3):273-82.",2020,The time for fulfilling the task in the Timed Up and Go Test improved in both groups (p < 0.05).,"['58 subjects (43 females and 15 males) aged 40-64 years, who presented with chronic unilateral vestibular dysfunction and were hospitalized', 'patients with chronic unilateral vestibular dysfunction']","['home-based unsupervised Cawthorne-Cooksey and balance exercises', 'vestibular rehabilitation', 'customized group vestibular rehabilitation', 'Cawthorne-Cooksey exercises and simple balance exercises twice a day for 15 min']","['vestibular compensation', 'Dizziness Handicap Inventory', 'Dynamic Gait Index']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2919794', 'cui_str': 'Dynamic gait index'}]",,0.0113366,The time for fulfilling the task in the Timed Up and Go Test improved in both groups (p < 0.05).,"[{'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Smółka', 'Affiliation': 'Medical University of Silesia, Katowice, Poland (Clinical Department of Otolaryngology).'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Smółka', 'Affiliation': 'Rehabilitation and Educational Center for Disabled Children in Jaworzno, Jaworzno, Poland.'}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Markowski', 'Affiliation': 'Medical University of Silesia, Katowice, Poland (Clinical Department of Otolaryngology).'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Pilch', 'Affiliation': 'Medical University of Silesia, Katowice, Poland (Clinical Department of Otolaryngology).'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Piotrowska-Seweryn', 'Affiliation': 'Medical University of Silesia, Katowice, Poland (Clinical Department of Otolaryngology).'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Zwierzchowska', 'Affiliation': 'Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland (Institute of Sport Science).'}]",International journal of occupational medicine and environmental health,['10.13075/ijomeh.1896.01330']
540,32237005,A behavioral economics-based telehealth intervention to improve aspirin adherence following hospitalization for acute coronary syndrome.,"PURPOSE


A significant number of patients with acute coronary syndrome (ACS) are nonadherent to aspirin after hospital discharge, with an associated increased risk of subsequent cardiovascular events. The purpose of this pilot study was to test the efficacy of a telehealth intervention based on behavioral economics to improve aspirin adherence following hospitalization for ACS.
METHODS


We enrolled 130 participants (c¯X = 58 ± 10.7 years of age, 38% female, 45% black) from two hospitals. Patients were eligible if they owned a smartphone and were admitted to the hospital for ACS, prescribed aspirin at discharge, and responsible for administering their own medications. Consenting participants were randomized to the intervention or usual care group. The intervention group was eligible to receive up to $50 per month if they took their medicine daily, with $2 per day deducted if a dose was missed. All participants received an electronic monitoring (EM) pill bottle containing a 90-day supply of aspirin, which was used to measure adherence calculated as the proportion of prescribed drug taken using the EM device. Based on the skewness in the adherence distribution, quantile regression was used to evaluate the effect of the intervention on median adherence over time.
RESULTS


After 90 days, adherence fell in the control group but remained high in the intervention group (median adherence 81% vs 90%, P = .18). Rehospitalization was higher in the control group (24% vs 13%, P = .17).
CONCLUSION


A loss aversion behavioral economics-based telehealth intervention is a promising approach to improving aspirin adherence following hospitalization for ACS.",2020,"Rehospitalization was higher in the control group (24% vs 13%, P = .17).
","['acute coronary syndrome', 'Patients were eligible if they owned a smartphone and were admitted to the hospital for ACS, prescribed aspirin at discharge, and responsible for administering their own medications', 'patients with acute coronary syndrome (ACS', '130 participants (c¯X = 58\u2009±\u200910.7\u2009years of age, 38% female, 45% black) from two hospitals', 'Consenting participants']","['aspirin', 'intervention or usual care group', 'behavioral economics-based telehealth intervention', 'electronic monitoring (EM) pill bottle containing a 90-day supply of aspirin', 'telehealth intervention']","['Rehospitalization', 'aspirin adherence', 'median adherence over time', 'adherence fell']","[{'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C5191365', 'cui_str': '10.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0336646', 'cui_str': 'Electronic monitor'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",130.0,0.040123,"Rehospitalization was higher in the control group (24% vs 13%, P = .17).
","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Riegel', 'Affiliation': 'School of Nursing at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Alisa', 'Initials': 'A', 'LastName': 'Stephens-Shields', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Jaskowiak-Barr', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Daus', 'Affiliation': 'School of Nursing at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Kimmel', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Pharmacoepidemiology and drug safety,['10.1002/pds.4988']
541,32236675,Multivariable Regression Analysis of Clinical Data from the Randomized-Controlled EffPac Trial: Efficacy of Femoropopliteal Drug-Coated Balloon Angioplasty.,"PURPOSE


The post-hoc multivariable analysis of EffPac study data aimed to identify explanatory variables for efficacy of femoropopliteal artery angioplasty.
METHODS


In the prospective, randomized, controlled EffPac study, patients were allocated to either DCB or plain old balloon angioplasty. Multivariable regression including interaction analysis was conducted to assess the impact of selected variables on the outcome measures of late lumen loss (LLL) at 6 months, and on binary restenosis, target lesion revascularization (TLR), clinical improvement, and hemodynamic improvement at 12 months.
RESULTS


A total of 171 patients (69 ± 8 years, 111 men) were treated at 11 German centers. Hypertension increased, and advanced age decreased LLL (B coefficient [B]: 0.7 [95% CI - 0.04 to 1.3], p = 0.06 and - 0.3 per 10 years [95% CI - 0.5 to 0.01], p = 0.06, respectively). DCB angioplasty decreased odds of 12-month TLR and binary restenosis (OR 0.4 [95% CI 0.2 to 0.8], p = 0.01 and OR 0.1 [95% CI 0.01 to 0.6], p = 0.02, respectively). Lesion length and severe calcification decreased clinical improvement (B: - 0.1 per 10 mm [95% CI - 0.1 to - 0.03], p = 0.001 and - 0.1 [95% CI - 1.7 to - 0.1], p = 0.03, respectively). DCB angioplasty in former smokers improved ABI (0.2 [95% CI 0.01 to 0.5], p = 0.04).
CONCLUSION


DCB angioplasty decreased the incidence of 12-month restenosis and TLR. Increasing lesion length and severe calcification reduced clinical improvement. Hypertension is suspected to facilitate, and advanced age to mitigate LLL. DCB improved ABI most in former smokers.",2020,"DCB angioplasty in former smokers improved ABI (0.2 [95% CI 0.01 to 0.5], p = 0.04).
","['171 patients (69\u2009±\u20098\xa0years, 111 men) were treated at 11 German centers']","['DCB angioplasty', 'Femoropopliteal Drug-Coated Balloon Angioplasty', 'DCB or plain old balloon angioplasty', 'femoropopliteal artery angioplasty']","['incidence of 12-month restenosis and TLR', 'Hypertension', 'late lumen loss (LLL', 'binary restenosis, target lesion revascularization (TLR), clinical improvement, and hemodynamic improvement', 'Lesion length and severe calcification decreased clinical improvement', 'DCB improved ABI', 'odds of 12-month TLR and binary restenosis', 'ABI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0000370', 'cui_str': ""3-3'dichlorobenzidine""}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0397654', 'cui_str': 'Angioplasty of artery'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C1261077', 'cui_str': 'Structure of lower lobe of left lung'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0000370', 'cui_str': ""3-3'dichlorobenzidine""}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}]",171.0,0.16622,"DCB angioplasty in former smokers improved ABI (0.2 [95% CI 0.01 to 0.5], p = 0.04).
","[{'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'Mietz', 'Affiliation': 'Department of Radiology, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lehmann', 'Affiliation': 'Center for Clinical Studies, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Teichgräber', 'Affiliation': 'Department of Radiology, Jena University Hospital, Jena, Germany. ulf.teichgraeber@med.uni-jena.de.'}]",Cardiovascular and interventional radiology,['10.1007/s00270-020-02452-2']
542,32172522,Neuroprotective Role of Oral Vitamin D Supplementation on Consciousness and Inflammatory Biomarkers in Determining Severity Outcome in Acute Traumatic Brain Injury Patients: A Double-Blind Randomized Clinical Trial.,"BACKGROUND AND OBJECTIVE


Early management of traumatic brain injury (TBI) is essential. We aimed to evaluate the efficacy of vitamin D over early clinical outcome and serum cytokine levels in patients with moderate to severe brain injury.
METHODS


Thirty-five patients with moderate to severe traumatic brain injury who were admitted to the ICU unit were recruited into the study. Subjects were randomly allocated to a treatment regimen comprising either a one-time oral dose of 120,000 IU (two tablets of 60,000 IU each) of vitamin D (n = 20) or 8 mg of saccharide (two tablets of 4 g each) as placebo (n = 15). The main parameters evaluated included duration of mechanical ventilation and ICU stay, Glasgow Coma Scale (GCS) and cytokine levels (interleukin (IL)-6, tumour necrosis factor (TNF)-α, interferon (IFN)-γ, IL-2).
RESULTS


The results indicated an improvement in the level of consciousness after 7 days in the vitamin D-treated group compared with placebo. An elevation in GCS score by 3.86 units in the vitamin D-treated group with a 0.19-unit descent in the control group was recorded. Duration of mechanical ventilation was reduced in the vitamin D-treated group compared with the control group (4.7 days vs. 8.2 days, p value 0.0001). A noticeable reduction was recorded in inflammatory biomarkers (cytokines) in the vitamin D-treated group (IL-6 p = 0.08, TNF-α p = 0.02, IL-2 p = 0.36) with notable elevation in IFN-γ (p = 0.65) compared to the control group.
CONCLUSION


In the acute phase of moderate to severe traumatic brain injury, vitamin D supplementation plays a vital role and has a favourable effect on the consciousness level of patients. Clinical trial Registry (CTRI) No. CTRI/2019/05/019259.",2020,The results indicated an improvement in the level of consciousness after 7 days in the vitamin D-treated group compared with placebo.,"['Acute Traumatic Brain Injury Patients', 'patients with moderate to severe brain injury', 'Thirty-five patients with moderate to severe traumatic brain injury who were admitted to the ICU unit were recruited into the study']","['saccharide', 'vitamin D', 'placebo', 'vitamin D supplementation', 'Oral Vitamin D Supplementation']","['level of consciousness', 'duration of mechanical ventilation and ICU stay, Glasgow Coma Scale (GCS) and cytokine levels (interleukin (IL)-6, tumour necrosis factor (TNF)-α, interferon (IFN)-γ, IL-2', 'Duration of mechanical ventilation', 'GCS score', 'IFN-γ', 'Consciousness and Inflammatory Biomarkers', 'inflammatory biomarkers (cytokines', 'serum cytokine levels']","[{'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0007004', 'cui_str': 'Carbohydrates'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0234425', 'cui_str': 'Level of consciousness (observable entity)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",35.0,0.333212,The results indicated an improvement in the level of consciousness after 7 days in the vitamin D-treated group compared with placebo.,"[{'ForeName': 'Swapnil', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Pharmacy, Banasthali Vidyapith, Banasthali, 304022, Rajasthan, India.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Pharmacy, Banasthali Vidyapith, Banasthali, 304022, Rajasthan, India.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Choudhary', 'Affiliation': 'Department of Neurosurgery, PGIMER, Dr. R.M.L. Hospital, New Delhi, 110001, India. ajay7.choudhary@gmail.com.'}, {'ForeName': 'Shallu', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Pharmacy, Banasthali Vidyapith, Banasthali, 304022, Rajasthan, India.'}, {'ForeName': 'Lipika', 'Initials': 'L', 'LastName': 'Khurana', 'Affiliation': 'Sir Ganga Ram Hospital, Institute of Obstetrics and Gynaecology, New Delhi, 110060, India.'}, {'ForeName': 'Neera', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Department of Biochemistry, PGIMER, Dr. R.M.L. Hospital, New Delhi, 110001, India.'}, {'ForeName': 'Vijender', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Department of Biochemistry, PGIMER, Dr. R.M.L. Hospital, New Delhi, 110001, India.'}, {'ForeName': 'Akansha', 'Initials': 'A', 'LastName': 'Bisht', 'Affiliation': 'Department of Pharmacy, Banasthali Vidyapith, Banasthali, 304022, Rajasthan, India.'}]",Clinical drug investigation,['10.1007/s40261-020-00896-5']
543,32240760,Ticagrelor With or Without Aspirin in High-Risk Patients With Diabetes Mellitus Undergoing Percutaneous Coronary Intervention.,"BACKGROUND


P2Y 12  inhibitor monotherapy with ticagrelor after a brief period of dual antiplatelet therapy can reduce bleeding without increasing ischemic harm after percutaneous coronary intervention (PCI). The impact of this approach among patients with diabetes mellitus (DM) remains unknown.
OBJECTIVES


The purpose of this study was to examine the effect of ticagrelor monotherapy versus ticagrelor plus aspirin among patients with DM undergoing PCI.
METHODS


This was a pre-specified analysis of the DM cohort in the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients after Coronary Intervention) trial. After 3 months of ticagrelor plus aspirin, patients were maintained on ticagrelor and randomized to aspirin or placebo for 1 year. The primary endpoint was Bleeding Academic Research Consortium 2, 3, or 5 bleeding. The composite ischemic endpoint was all-cause death, myocardial infarction, or stroke.
RESULTS


Patients with DM comprised 37% (n = 2,620) of the randomized cohort and were characterized by more frequent comorbidities and a higher prevalence of multivessel disease. The incidence of Bleeding Academic Research Consortium 2, 3, or 5 bleeding was 4.5% and 6.7% among patients with DM randomized to ticagrelor plus placebo versus ticagrelor plus aspirin (hazard ratio: 0.65; 95% confidence interval: 0.47 to 0.91; p = 0.012). Ticagrelor monotherapy was not associated with an increase in ischemic events compared with ticagrelor plus aspirin (4.6% vs. 5.9%; hazard ratio: 0.77; 95% confidence interval: 0.55 to 1.09; p = 0.14). In the overall trial population, there was no significant interaction between DM status and treatment group for the primary bleeding or ischemic endpoints.
CONCLUSIONS


Compared with ticagrelor plus aspirin, the effect of ticagrelor monotherapy in reducing the risk of clinically relevant bleeding without any increase in ischemic events was consistent among patients with or without DM undergoing PCI. (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention [TWILIGHT]; NCT02270242).",2020,Ticagrelor monotherapy was not associated with an increase in ischemic events compared with ticagrelor plus aspirin (4.6% vs 5.9%; HR 0.77; 95% CI 0.55 to 1.09; p=0.14).,"['patients with or without DM undergoing PCI', 'High-Risk Patients with Diabetes Mellitus undergoing Percutaneous Coronary Intervention', 'patients with DM undergoing PCI', 'patients with diabetes mellitus (DM']","['ticagrelor plus aspirin', 'aspirin or placebo', 'ticagrelor monotherapy versus ticagrelor plus aspirin', 'Ticagrelor with or without Aspirin', 'ticagrelor plus placebo', 'ticagrelor', 'ticagrelor monotherapy', 'Ticagrelor monotherapy']","['primary bleeding or ischemic endpoints', 'incidence of BARC 2, 3 or 5 bleeding', 'multivessel disease', 'ischemic events', 'cause death, myocardial infarction, or stroke', 'Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]",,0.232331,Ticagrelor monotherapy was not associated with an increase in ischemic events compared with ticagrelor plus aspirin (4.6% vs 5.9%; HR 0.77; 95% CI 0.55 to 1.09; p=0.14).,"[{'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Baber', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Sartori', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Briguori', 'Affiliation': 'Mediterranea Cardiocentro, Naples, Italy.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dangas', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'University of Missouri-Kansas City, Kansas City, Missouri.'}, {'ForeName': 'Shamir R', 'Initials': 'SR', 'LastName': 'Mehta', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Chandiramani', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': '3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminen Hospital, and Sigmund Freud University, Medical Faculty, Vienna, Austria.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Kornowski', 'Affiliation': 'Cardiology Department, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Giora', 'Initials': 'G', 'LastName': 'Weisz', 'Affiliation': 'Department of Cardiology, Montefiore Medical Center, Bronx, New York.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Kunadian', 'Affiliation': 'Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University and Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Keith G', 'Initials': 'KG', 'LastName': 'Oldroyd', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Ya-Ling', 'Affiliation': 'Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, Liaoning, China.'}, {'ForeName': 'Upendra', 'Initials': 'U', 'LastName': 'Kaul', 'Affiliation': 'Batra Hospital and Medical Research Center, New Delhi, India.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Witzenbichler', 'Affiliation': 'Department of Cardiology and Pneumology, Helios Amper-Klinikum, Dachau, Germany.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Dudek', 'Affiliation': 'Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland; Maria Cecilia Hospital, GVM Care & Research, Cotignola (RA), Italy.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Sardella', 'Affiliation': 'Department of Cardiology, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clínico San Carlos IDISCC, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Samin', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Shlofmitz', 'Affiliation': 'St. Francis Hospital, Roslyn, New York.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Collier', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Pocock', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: roxana.mehran@mountsinai.org.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.03.008']
544,31607468,Hepcidin-guided screen-and-treat interventions against iron-deficiency anaemia in pregnancy: a randomised controlled trial in The Gambia.,"BACKGROUND


WHO recommends daily iron supplementation for pregnant women, but adherence is poor because of side-effects, effectiveness is low, and there are concerns about possible harm. The iron-regulatory hormone hepcidin can signal when an individual is ready-and-safe to receive iron. We tested whether a hepcidin-guided screen-and-treat approach to combat iron-deficiency anaemia could achieve equivalent efficacy to universal administration, but with lower exposure to iron.
METHODS


We did a three-arm, randomised, double-blind, non-inferiority trial in 19 rural communities in the Jarra West and Kiang East districts of The Gambia. Eligible participants were pregnant women aged 18-45 years at between 14 weeks and 22 weeks of gestation. We randomly allocated women to either WHO's recommended regimen (ie, a daily UN University, UNICEF, and WHO international multiple-micronutrient preparation [UNIMMAP] containing 60 mg iron), a 60 mg screen-and-treat approach (ie, daily UNIMMAP containing 60 mg iron for 7 days if weekly hepcidin was <2·5 μg/L or UNIMMAP without iron if hepcidin was ≥2·5 μg/L), or a 30 mg screen-and-treat approach (ie, daily UNIMMAP containing 30 mg iron for 7 days if weekly hepcidin was <2·5 μg/L or UNIMMAP without iron if hepcidin was ≥2·5 μg/L). We used a block design stratified by amount of haemoglobin at enrolment (above and below the median amount of haemoglobin on every enrolment day) and stage of gestation (14-18 weeks vs 19-22 weeks). Participants and investigators were unaware of the random allocation. The primary outcome was the amount of haemoglobin at day 84 and was measured as the difference in haemoglobin in each screen-and-treat group compared with WHO's recommended regimen; the non-inferiority margin was set at -5·0 g/L. The primary outcome was assessed in the per-protocol population, which comprised all women who completed the study. This trial is registered with the ISRCTN registry, number ISRCTN21955180.
FINDINGS


Between June 16, 2014, and March 3, 2016, 498 participants were randomised, of whom 167 were allocated to WHO's recommended regimen, 166 were allocated to the 60 mg per day screen-and-treat approach, and 165 were allocated to the 30 mg per day screen-and-treat approach. 78 participants were withdrawn or lost to follow-up during the study; thus, the per-protocol population comprised 140 women assigned to WHO's recommended regimen, 133 allocated to the 60 mg screen-and-treat approach, and 147 allocated to the 30 mg screen-and-treat approach. The screen-and-treat approaches did not exceed the non-inferiority margin. Compared with WHO's recommended regimen, the difference in the amount of haemoglobin at day 84 was -2·2 g/L (95% CI -4·6 to 0·1) with the 60 mg screen-and-treat approach and -2·7 g/L (-5·0 to -0·5) with the 30 mg screen-and-treat approach. Adherence, reported side-effects, and adverse events were similar between the three groups. The most frequent side-effect was stomachache, which was similar in the 60 mg screen-and-treat group (82 cases per 1906 person-weeks) and with WHO's recommended regimen (81 cases per 1974 person-weeks; effect 1·0, 95% CI 0·7 to 1·6); in the 30 mg screen-and-treat group the frequency of stomachache was slightly lower than with WHO's recommended regimen (58 cases per 2009 person-weeks; effect 0·7, 95% CI 0·5 to 1·1). No participants died during the study.
INTERPRETATION


The hepcidin-guided screen-and-treat approaches had no advantages over WHO's recommended regimen in terms of adherence, side-effects, or safety outcomes. Our results suggest that the current WHO policy for iron administration to pregnant women should remain unchanged while more effective approaches continue to be sought.
FUNDING


Bill & Melinda Gates Foundation and the UK Medical Research Council.",2019,"The most frequent side-effect was stomachache, which was similar in the 60 mg screen-and-treat group (82 cases per 1906 person-weeks) and with WHO's recommended regimen (81 cases per 1974 person-weeks; effect 1·0, 95% CI 0·7 to 1·6); in the 30 mg screen-and-treat group the frequency of stomachache was slightly lower than with WHO's recommended regimen (58 cases per 2009 person-weeks; effect 0·7, 95% CI 0·5 to 1·1).","['19 rural communities in the Jarra West and Kiang East districts of The Gambia', ""78 participants were withdrawn or lost to follow-up during the study; thus, the per-protocol population comprised 140 women assigned to WHO's recommended regimen, 133 allocated to the 60 mg"", 'deficiency anaemia in pregnancy', 'Eligible participants were pregnant women aged 18-45 years at between 14 weeks and 22 weeks of gestation', 'Between June 16, 2014, and March 3, 2016', '498 participants', 'pregnant women']","['hepcidin-guided screen-and-treat approach to combat iron-deficiency anaemia', ""WHO's recommended regimen (ie, a daily UN University, UNICEF, and WHO international multiple-micronutrient preparation [UNIMMAP] containing 60 mg iron), a 60 mg screen-and-treat approach (ie, daily UNIMMAP containing 60 mg iron for 7 days if weekly hepcidin was <2·5 μg/L or UNIMMAP without iron if hepcidin was ≥2·5 μg/L), or a 30 mg screen-and-treat approach (ie, daily UNIMMAP containing 30 mg iron for 7 days if weekly hepcidin was <2·5 μg/L or UNIMMAP without iron if hepcidin was ≥2·5 μg/L"", 'screen-and-treat approach, and 147 allocated to the 30 mg screen-and-treat approach', 'Hepcidin-guided screen-and-treat interventions against iron']","['haemoglobin', 'frequency of stomachache', 'Adherence, reported side-effects, and adverse events', 'amount of haemoglobin']","[{'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0325167', 'cui_str': 'Equus kiang (organism)'}, {'cui': 'C0016993', 'cui_str': 'Republic of the Gambia'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0041782', 'cui_str': 'Deficiency anemias (disorder)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0966897', 'cui_str': 'Liver-Expressed Antimicrobial Peptide'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0041682', 'cui_str': 'UNICEF'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0221512', 'cui_str': 'Stomach ache (finding)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",498.0,0.359444,"The most frequent side-effect was stomachache, which was similar in the 60 mg screen-and-treat group (82 cases per 1906 person-weeks) and with WHO's recommended regimen (81 cases per 1974 person-weeks; effect 1·0, 95% CI 0·7 to 1·6); in the 30 mg screen-and-treat group the frequency of stomachache was slightly lower than with WHO's recommended regimen (58 cases per 2009 person-weeks; effect 0·7, 95% CI 0·5 to 1·1).","[{'ForeName': 'Amat', 'Initials': 'A', 'LastName': 'Bah', 'Affiliation': 'Medical Research Council (MRC) Unit The Gambia at London School of Hygiene & Tropical Medicine (LSHTM), Serrekunda, The Gambia; LSHTM, London, UK.'}, {'ForeName': 'Abdul Khalie', 'Initials': 'AK', 'LastName': 'Muhammad', 'Affiliation': 'Medical Research Council (MRC) Unit The Gambia at London School of Hygiene & Tropical Medicine (LSHTM), Serrekunda, The Gambia.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Wegmuller', 'Affiliation': 'Medical Research Council (MRC) Unit The Gambia at London School of Hygiene & Tropical Medicine (LSHTM), Serrekunda, The Gambia; GroundWork, Flaesch, Switzerland.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Verhoef', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, Wageningen, Netherlands; LSHTM, London, UK.'}, {'ForeName': 'Morgan M', 'Initials': 'MM', 'LastName': 'Goheen', 'Affiliation': 'Medical Research Council (MRC) Unit The Gambia at London School of Hygiene & Tropical Medicine (LSHTM), Serrekunda, The Gambia; University of North Carolina at Chapel Hill School of Medicine, Department of Microbiology and Immunology, Chapel Hill, NC, USA.'}, {'ForeName': 'Saikou', 'Initials': 'S', 'LastName': 'Sanyang', 'Affiliation': 'Medical Research Council (MRC) Unit The Gambia at London School of Hygiene & Tropical Medicine (LSHTM), Serrekunda, The Gambia.'}, {'ForeName': 'Ebrima', 'Initials': 'E', 'LastName': 'Danso', 'Affiliation': 'Medical Research Council (MRC) Unit The Gambia at London School of Hygiene & Tropical Medicine (LSHTM), Serrekunda, The Gambia.'}, {'ForeName': 'Ebrima A', 'Initials': 'EA', 'LastName': 'Sise', 'Affiliation': 'Medical Research Council (MRC) Unit The Gambia at London School of Hygiene & Tropical Medicine (LSHTM), Serrekunda, The Gambia.'}, {'ForeName': 'Sant-Rayn', 'Initials': 'SR', 'LastName': 'Pasricha', 'Affiliation': 'Population Health and Immunity Division, The Walter and Eliza Hall Institute of Medical Research, and Department of Medical Biology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Armitage', 'Affiliation': 'MRC Human Immunology Unit, MRC Weatherall Institute of Molecular Medicine, University of Oxford, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Hal', 'Initials': 'H', 'LastName': 'Drakesmith', 'Affiliation': 'MRC Human Immunology Unit, MRC Weatherall Institute of Molecular Medicine, University of Oxford, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Cross', 'Affiliation': 'Medical Research Council (MRC) Unit The Gambia at London School of Hygiene & Tropical Medicine (LSHTM), Serrekunda, The Gambia; LSHTM, London, UK.'}, {'ForeName': 'Sophie E', 'Initials': 'SE', 'LastName': 'Moore', 'Affiliation': ""Medical Research Council (MRC) Unit The Gambia at London School of Hygiene & Tropical Medicine (LSHTM), Serrekunda, The Gambia; Department of Women & Children's Health, King's College London, St Thomas' Hospital, London, UK.""}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Cerami', 'Affiliation': 'LSHTM, London, UK.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Prentice', 'Affiliation': 'Medical Research Council (MRC) Unit The Gambia at London School of Hygiene & Tropical Medicine (LSHTM), Serrekunda, The Gambia; LSHTM, London, UK. Electronic address: aprentice@mrc.gm.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30393-6']
545,32236732,Effects of ertugliflozin on renal function over 104 weeks of treatment: a post hoc analysis of two randomised controlled trials.,"AIMS/HYPOTHESIS


This study aimed to evaluate the effect of ertugliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, on eGFR and albuminuria (urine albumin/creatinine ratio [UACR]) vs glimepiride or placebo/glimepiride (non-ertugliflozin) over 104 weeks of treatment in participants with type 2 diabetes mellitus, using pooled data from two randomised controlled, active comparator studies from the eValuation of ERTugliflozin effIcacy and Safety (VERTIS) programme (Clinicaltrials.gov NCT01999218 [VERTIS SU] and NCT02033889 [VERTIS MET]). In the VERTIS SU study, ertugliflozin was evaluated vs glimepiride over 104 weeks. In the VERTIS MET study, ertugliflozin was evaluated vs placebo over 26 weeks; eligible participants were switched from placebo to blinded glimepiride from week 26 to week 104. The glycaemic efficacy of ertugliflozin vs non-ertugliflozin was also assessed in the pooled population.
METHODS


Post hoc, exploratory analysis was used to investigate mean changes from baseline in eGFR and UACR over 104 weeks.
RESULTS


Overall, mean (SD) baseline eGFR was 88.2 (18.8) ml min -1  (1.73 m) -2  and geometric mean (95% CI) of baseline UACR was 1.31 mg/mmol (1.23, 1.38). At week 6, the changes in eGFR from baseline were -2.3, -2.7 and -0.7 ml min -1  (1.73 m) -2  for the ertugliflozin 5 mg, ertugliflozin 15 mg and non-ertugliflozin groups, respectively. Mean eGFR in the ertugliflozin groups increased over time thereafter, while it decreased in the non-ertugliflozin group. Week 104 changes in eGFR from baseline were -0.2, 0.1 and -2.0 ml min -1  (1.73 m) -2  for the ertugliflozin 5 mg, ertugliflozin 15 mg and non-ertugliflozin groups, respectively. Among 415 patients (21.4% of the cohort) with albuminuria at baseline, the ertugliflozin groups had greater reductions in UACR at all measured time points up to week 104. At week 104, the non-ertugliflozin-corrected difference in UACR (95% CI) was -29.5% (-44.8, -9.8; p < 0.01) for ertugliflozin 5 mg and -37.6% (-51.8, -19.2; p < 0.001) for ertugliflozin 15 mg. Least squares mean changes from baseline in HbA 1c  (mmol/mol [95% CI]) at week 104 were similar between treatment groups: -6.84 (-7.64, -6.03), -7.74 (-8.54, -6.94) and -6.84 (-7.65, -6.03) in the ertugliflozin 5 mg, ertugliflozin 15 mg and non-ertugliflozin groups, respectively. Least squares mean changes from baseline in HbA1 c  (% [95% CI]) at week 104 were: -0.63 (-0.70, -0.55), -0.71 (-0.78, -0.64) and -0.63 (-0.70, -0.55) in the ertugliflozin 5 mg, ertugliflozin 15 mg and non-ertugliflozin groups, respectively.
CONCLUSIONS/INTERPRETATION


Ertugliflozin reduced eGFR at week 6, consistent with the known pharmacodynamic effects of SGLT2 inhibitors on renal function. Over 104 weeks, eGFR values returned to baseline and were higher with ertugliflozin compared with non-ertugliflozin treatment, even though changes in HbA 1c  did not differ between the groups. Ertugliflozin reduced UACR in patients with baseline albuminuria.
TRIAL REGISTRATION


clinicaltrials.gov NCT01999218 and NCT02033889.",2020,"At week 6, the changes in eGFR from baseline were -2.3, -2.7 and -0.7 ","['participants with type 2 diabetes mellitus', 'patients with baseline albuminuria']","['glimepiride', 'placebo', 'ertugliflozin 15\xa0mg and non-ertugliflozin', 'ertugliflozin vs non-ertugliflozin', 'Ertugliflozin', 'glimepiride or placebo/glimepiride (non-ertugliflozin', 'placebo to blinded glimepiride', 'ertugliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor', 'ertugliflozin']","['UACR', 'glycaemic efficacy', 'ERTugliflozin effIcacy and Safety (VERTIS) programme', 'eGFR and albuminuria (urine albumin/creatinine ratio [UACR', 'Overall, mean (SD) baseline eGFR', 'Mean eGFR', 'eGFR values', 'renal function']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}]","[{'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4535690', 'cui_str': 'ertugliflozin 15 MG'}, {'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0455271', 'cui_str': 'Urine albumin/creatinine ratio measurement'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",415.0,0.194555,"At week 6, the changes in eGFR from baseline were -2.3, -2.7 and -0.7 ","[{'ForeName': 'David Z I', 'Initials': 'DZI', 'LastName': 'Cherney', 'Affiliation': 'Division of Nephrology, University of Toronto, Toronto General Hospital, 585 University Ave, 8N-845, Toronto, ON, M5G 2N2, Canada. david.cherney@uhn.ca.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Frederich', 'Affiliation': 'Pfizer Inc., Collegeville, PA, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Maldonado', 'Affiliation': 'Merck Sharp & Dohme Limited, London, UK.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Annpey', 'Initials': 'A', 'LastName': 'Pong', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Zhi J', 'Initials': 'ZJ', 'LastName': 'Xu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Shrita', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hickman', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Mancuso', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gantz', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': 'Pfizer Inc., Andover, MA, USA.'}]",Diabetologia,['10.1007/s00125-020-05133-4']
546,32233247,"[Dynamic orthosis with  Shujinxi  (, SJX) external granule for the treatment of collateral ligament contracture of metacarpophalangeal joint].","OBJECTIVE


To explore clinical efficacy of hand power device and  Shujinxi  (, SJX) external granule in treating collateral ligament contracture of metacarpophalangeal joint.
METHODS


Fifty patients with collateral ligament contracture of metacarpophalangeal joint from June 2017 to January 2019 were divided into experimental and control group, 25 patients in each group. In experimental group, there were 17 males and 8 females aged from 19 to 63 years old with an average of (40.53±9.42) years old; 36 affected fingers; the courses of disease ranged from 23 to 82 days with an average of (52.37± 11.20) days; treated with hand power device and SJX external granule. In control group, there were 15 males and 10 females aged from 21 to 58 years old with an average of (42.11±8.36) years old; 32 affected fingers; the courses of diseases ranged from 18 to 71 days with an average of (48.24±12.50) days; treated with loose training of metacarpophalangeal joints. Symptoms of pain of affected finger, flexion and extension function were observed between two groups, VAS score was used to evaluate relieve degree of pain, grip size was used to evaluate recovery of grip, total active motion was applied to assess recovery of metacarpophalangeal joints, the second operation and occurrence of complications between two groups were compared.
RESULTS


All patients were followed up about 8 weeks. VAS score, total active motion of metacarpophalangeal joints and grip of affected finger before and after treatment in experimental group were (4.22±1.09) point vs (1.98±1.01) point ,(17.40±6.31) ° vs (70.95±7.68) ° ,(4.83±3.09) kg vs (23.17±10.54) kg respectively, while in control group were (4.66±0.95) point vs (2.84± 1.06) point ,(16.25±5.66) ° vs (59.14±10.61) ° ,(5.06±4.05) kg vs (16.25±9.66) kg; there were statistical difference between two groups before and after treatment, and these items in experimental group after treatment were higher than that of control group ( P <0.05) . There were no complicationsoccurred betweentwo groups. Onepatientinexperimentalgroup and 8 patients in controlgroupneededto bethesecondoperation, andhadsignificancedifference ( P <0.05) .
CONCLUSION


Handpowerdevice and SJXexternalgranulecouldobviouslyrelievesymptomsof pain of affected finger, improve recovery of grip strength, increase total active motion, and has good safety. It is an effective method for treating for the treatment of collateral ligament contracture of metacarpophalangeal joint.",2020,It is an effective method for treating for the treatment of collateral ligament contracture of metacarpophalangeal joint.,"['Fifty patients with collateral ligament contracture of metacarpophalangeal joint from June 2017 to January 2019', '15 males and 10 females aged from 21 to 58 years old with an average of (42.11±8.36) years old; 32 affected fingers; the courses of diseases ranged from 18 to 71 days with an average of (48.24±12.50) days; treated with loose training of metacarpophalangeal joints', 'collateral ligament contracture of metacarpophalangeal joint', '17 males and 8 females aged from 19 to 63 years old with an average of (40.53±9.42) years old; 36 affected fingers; the courses of disease ranged from 23 to 82 days with an average of (52.37± 11.20) days; treated with hand power device and SJX external granule']","['hand power device and  Shujinxi  (, SJX) external granule', 'Dynamic orthosis with  Shujinxi  (, SJX) external granule']","['recovery of grip strength, increase total active motion', 'recovery of metacarpophalangeal joints, the second operation and occurrence of complications', 'Symptoms of pain of affected finger, flexion and extension function', 'VAS score, total active motion of metacarpophalangeal joints and grip of affected finger']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206365', 'cui_str': 'Collateral Ligaments'}, {'cui': 'C0009917', 'cui_str': 'Contracture'}, {'cui': 'C0025525', 'cui_str': 'Metacarpophalangeal Joint'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205407', 'cui_str': 'Loose (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C3853573', 'cui_str': 'Granules'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C3853573', 'cui_str': 'Granules'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}]","[{'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0231481', 'cui_str': 'Active movement (observable entity)'}, {'cui': 'C0025525', 'cui_str': 'Metacarpophalangeal Joint'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}]",50.0,0.0196906,It is an effective method for treating for the treatment of collateral ligament contracture of metacarpophalangeal joint.,"[{'ForeName': 'Li-Juan', 'Initials': 'LJ', 'LastName': 'Xie', 'Affiliation': 'Department of Reparative and Reconstructive Surgery, Foshan Hospital of TCM, Foshan 528000, Guangdong, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Reparative and Reconstructive Surgery, Foshan Hospital of TCM, Foshan 528000, Guangdong, China.'}, {'ForeName': 'Ying-Qiong', 'Initials': 'YQ', 'LastName': 'Wang', 'Affiliation': 'Department of Reparative and Reconstructive Surgery, Foshan Hospital of TCM, Foshan 528000, Guangdong, China.'}, {'ForeName': 'Hui-Ping', 'Initials': 'HP', 'LastName': 'Ye', 'Affiliation': 'Department of Reparative and Reconstructive Surgery, Foshan Hospital of TCM, Foshan 528000, Guangdong, China.'}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2020.03.006']
547,32233611,A comprehensive health classification model based on support vector machine for proseal laryngeal mask and tracheal catheter assessment in herniorrhaphy.,"Purpose:  In order to classify different types of health data collected in clinical practice of hernia surgery more effectively and improve the classification performance of support vector machine (SVM).  Methods:  A prospective randomized study was conducted. Sixty patients undergoing hernia repair under general anesthesia were randomly divided into two groups, PLMA group ( n  = 30) and ETT group ( n  = 30), for airway management. Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, respiratory parameters and the incidence of complications related to ProSeal laryngeal mask airway (PLMA) and endotracheal tube (ETT) were collected in clinical experiments in order to evaluate the operation condition. On the basis of this experiment, at first, expert credibility is introduced to process the index value; secondly, the classification weight of the index is objectively determined by the information entropy output of the index itself; finally, a comprehensive classification model of support vector machine based on key sample set is proposed and its advantages are evaluated.  Result:  After classifying the experimental data, we found that SVM can accurately judge the effect of surgery by data. In this experiment, PLMA method is better than ETT method in xenon repair operation. Discussion: SVM has great accuracy and practicability in judging the outcome of xenon repair operation.  Conclusion:  The proposed index classification weight model can deal with the uncertainties caused by uncertain information and give the confidence of the uncertain information. Compared with the traditional SVM method, the proposed method based on SVM and key sample set greatly reduces the number of samples that misjudge the effect of samples, and improves the practicability of SVM method. It is concluded that PLMA is superior to the ETT technique to hernia surgical. The idea of constructing classification model based on key sample set proposed in this paper can also be used for reference in other data mining methods.",2019,"Compared with the traditional SVM method, the proposed method based on SVM and key sample set greatly reduces the number of samples that misjudge the effect of samples, and improves the practicability of SVM method.","['Sixty patients undergoing hernia repair under general anesthesia', 'herniorrhaphy', 'Discussion']","['PLMA', 'SVM']","['Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, respiratory parameters and the incidence of complications related to ProSeal laryngeal mask airway (PLMA) and endotracheal tube (ETT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}]",[],"[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}]",60.0,0.0216416,"Compared with the traditional SVM method, the proposed method based on SVM and key sample set greatly reduces the number of samples that misjudge the effect of samples, and improves the practicability of SVM method.","[{'ForeName': 'Zhen Shuang', 'Initials': 'ZS', 'LastName': 'Du', 'Affiliation': 'General Practice, The Second Affiliated Hospital of Fujian Medical University, Quanzhou 362000, Fujian, China.'}, {'ForeName': 'Qing Wei', 'Initials': 'QW', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, Shishi City Hospital, Shishi 362700, Fujian, China.'}, {'ForeName': 'He Fan', 'Initials': 'HF', 'LastName': 'He', 'Affiliation': 'General Practice, The Second Affiliated Hospital of Fujian Medical University, Quanzhou 362000, Fujian, China.'}, {'ForeName': 'Ming Xia', 'Initials': 'MX', 'LastName': 'Qiu', 'Affiliation': 'Hubin Street Health Service Centre of Shishi, Shishi 360007, Fujian, China.'}, {'ForeName': 'Zhi Yao', 'Initials': 'ZY', 'LastName': 'Chen', 'Affiliation': 'General Practice, The Second Affiliated Hospital of Fujian Medical University, Quanzhou 362000, Fujian, China.'}, {'ForeName': 'Qing Fu', 'Initials': 'QF', 'LastName': 'Hu', 'Affiliation': 'General Practice, The Second Affiliated Hospital of Fujian Medical University, Quanzhou 362000, Fujian, China.'}, {'ForeName': 'Qing Mao', 'Initials': 'QM', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery, Shishi City Hospital, Shishi 362700, Fujian, China.'}, {'ForeName': 'Zi Ping', 'Initials': 'ZP', 'LastName': 'Zhang', 'Affiliation': 'General Practice, The Second Affiliated Hospital of Fujian Medical University, Quanzhou 362000, Fujian, China.'}, {'ForeName': 'Qiong Hua', 'Initials': 'QH', 'LastName': 'Lin', 'Affiliation': 'General Practice, The Second Affiliated Hospital of Fujian Medical University, Quanzhou 362000, Fujian, China.'}, {'ForeName': 'Liu Yue', 'Initials': 'LY', 'LastName': 'Huang', 'Affiliation': 'General Practice, The Second Affiliated Hospital of Fujian Medical University, Quanzhou 362000, Fujian, China.'}, {'ForeName': 'Ya Jiao', 'Initials': 'YJ', 'LastName': 'Huang', 'Affiliation': 'General Practice, The Second Affiliated Hospital of Fujian Medical University, Quanzhou 362000, Fujian, China.'}]",Mathematical biosciences and engineering : MBE,['10.3934/mbe.2020097']
548,32234463,Bioprosthetic Aortic Valve Leaflet Thickening in the Evolut Low Risk Sub-Study.,"BACKGROUND


Subclinical leaflet thrombosis has been reported after bioprosthetic aortic valve replacement, characterized using 4-dimensional computed tomographic imaging by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion (RLM). The incidence and clinical implications of these findings remain unclear.
OBJECTIVES


The aim of this study was to determine the frequency, predictors, and hemodynamic and clinical correlates of HALT and RLM after aortic bioprosthetic replacement.
METHODS


A prospective subset of patients not on oral anticoagulation enrolled in the Evolut Low Risk randomized trial underwent computed tomographic imaging 30 days and 1 year after transcatheter aortic valve replacement (TAVR) or surgery. The primary endpoint was the frequency of HALT at 30 days and 1 year, analyzed by an independent core laboratory using standardized definitions. Secondary endpoints included RLM, mean aortic gradient, and clinical events at 30 days and 1 year.
RESULTS


At 30 days, the frequency of HALT was 31 of 179 (17.3%) for TAVR and 23 of 139 (16.5%) for surgery; the frequency of RLM was 23 of 157 (14.6%) for TAVR and 19 of 133 (14.3%) for surgery. At 1 year, the frequency of HALT was 47 of 152 (30.9%) for TAVR and 33 of 116 (28.4%) for surgery; the frequency of RLM was 45 of 145 (31.0%) for TAVR and 30 of 111 (27.0%) for surgery. Aortic valve hemodynamic status was not influenced by the presence or severity of HALT or RLM at either time point. The rates of HALT and RLM were similar after the implantation of supra-annular, self-expanding transcatheter, or surgical bioprostheses.
CONCLUSIONS


The presence of computed tomographic imaging abnormalities of aortic bioprostheses were frequent but dynamic in the first year after self-expanding transcatheter and surgical aortic valve replacement, but these findings did not correlate with aortic valve hemodynamic status after aortic valve replacement in patients at low risk for surgery. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283).",2020,"The rates of HALT and RLM were similar after implantation of supraannular, self-expanding transcatheter or surgical bioprostheses.
",['patients not on oral anticoagulation enrolled in the Evolut Low Risk randomized trial underwent CT imaging 30 days and 1 year after TAVR or surgery'],['Aortic Valve Replacement'],"['RLM, mean aortic gradient, and clinical events at 30 days and 1 year', 'frequency of HALT', 'Aortic valve hemodynamics', 'Leaflet Thickening or Immobility', 'rates of HALT and RLM', 'aortic valve hemodynamics', 'frequency of RLM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0003501', 'cui_str': 'Aortic valve structure'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}, {'cui': 'C0231441', 'cui_str': 'Immobile'}]",,0.0891187,"The rates of HALT and RLM were similar after implantation of supraannular, self-expanding transcatheter or surgical bioprostheses.
","[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Blanke', 'Affiliation': ""Center for Heart Valve Innovation, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: phil.blanke@gmail.com.""}, {'ForeName': 'Jonathon A', 'Initials': 'JA', 'LastName': 'Leipsic', 'Affiliation': ""Center for Heart Valve Innovation, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Popma', 'Affiliation': 'Department of Interventional Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Yakubov', 'Affiliation': 'Department of Interventional Cardiology, OhioHealth Riverside Methodist Hospital, Columbus, Ohio.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Deeb', 'Affiliation': 'Department of Cardiac Surgery, University of Michigan Health System-University Hospital, Ann Arbor, Michigan.'}, {'ForeName': 'Hemal', 'Initials': 'H', 'LastName': 'Gada', 'Affiliation': 'Departments of Thoracic Surgery and Interventional Cardiology, UPMC Pinnacle, Harrisburg, Pennsylvania.'}, {'ForeName': 'Mubashir', 'Initials': 'M', 'LastName': 'Mumtaz', 'Affiliation': 'Departments of Thoracic Surgery and Interventional Cardiology, UPMC Pinnacle, Harrisburg, Pennsylvania.'}, {'ForeName': 'Basel', 'Initials': 'B', 'LastName': 'Ramlawi', 'Affiliation': 'Department of Cardiothoracic Surgery, Winchester Medical Center, Winchester, Virginia.'}, {'ForeName': 'Neal S', 'Initials': 'NS', 'LastName': 'Kleiman', 'Affiliation': 'Department of Cardiology, Methodist DeBakey Heart and Vascular Center, Houston, Texas.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sorajja', 'Affiliation': 'Departments of Thoracic Surgery and Interventional Cardiology, Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota.'}, {'ForeName': 'Judah', 'Initials': 'J', 'LastName': 'Askew', 'Affiliation': 'Departments of Thoracic Surgery and Interventional Cardiology, Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota.'}, {'ForeName': 'Christopher U', 'Initials': 'CU', 'LastName': 'Meduri', 'Affiliation': 'Departments of Cardiac Surgery and Interventional Cardiology, Piedmont Atlanta Hospital, Atlanta, Georgia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kauten', 'Affiliation': 'Departments of Cardiac Surgery and Interventional Cardiology, Piedmont Atlanta Hospital, Atlanta, Georgia.'}, {'ForeName': 'Serguei', 'Initials': 'S', 'LastName': 'Melnitchouk', 'Affiliation': 'Departments of Cardiac Surgery and Interventional Cardiology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Inglessis', 'Affiliation': 'Departments of Cardiac Surgery and Interventional Cardiology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Statistics, Medtronic, Minneapolis, Minnesota.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boulware', 'Affiliation': 'Department of Statistics, Medtronic, Minneapolis, Minnesota.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Reardon', 'Affiliation': 'Department of Cardiothoracic Surgery, Methodist DeBakey Heart and Vascular Center, Houston, Texas.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.03.022']
549,32233245,[Platelet rich plasma intra-articular and extra-articular injection for the treatment of knee osteoarthritis].,"OBJECTIVE


To observe clinical effects of platelet-rich plasma (PRP) intra-articular and extra-articular injection for patients with knee osteoarthritis (KOA), and analyze its safety and clinical efficacy.
METHODS


From January to December 2017, 48 patients with KOA were randomly divided into observation group and control group, 24 cases in each group. The observation group was treated with intra-articular injection of PRP (2 ml) and extra-articular injection of PRP (2 ml), once a week, for three times, including 8 males and 16 females with an average of (58.04±7.87) years old ranging from 43 to 68 years old, the courses of disease ranged from 1 to 8 years with an average of (4.69±1.96) years, the body mass index (BMI) was (24.53±5.26) kg/m 2 . The control group was treated with intra-articular injection of sodium hyaluronate (20 mg), extra-articular injection of analgesic drug (2 ml for one point), once a week, for three times, including 7 males and 17 females with an average of (60.54±8.93) years old ranging from 47 to 72 years old, the courses of disease ranged from 1.5 to 9 years with an average of (5.27±1.68) years, BMI was (23.47±4.62) kg/m 2 . VAS score and Lysholm score before operation and the 1st, 6th month after treatment were compared between two groups.
RESULTS


All patients were followed up at least 6 months without occurrence serious adverse reactions or complications. VAS score in observation group and control group before treatment and 1st, 6th month after treatment were 7.35±1.47, 4.15±1.52, 2.26±1.02 and 7.51±1.39, 3.84±1.76, 3.66±1.18, respectively; VAS score in obsevation group was lower than that of control group at 6 months after treatment. Lysholm score in observation group and control group before treatment and 1st, 6th month after treatment were 55.21±5.78, 79.16±7.25, 85.45±6.87 and 54.65± 6.40, 77.58±6.94, 82.34±7.12. There were significant differences in Lysholm score before and after injection between two groups ( P <0.05) . There was no significant difference in Lysholm score between two groups at 1 month after treatment ( P >0.05), while Lysholm score in observation group was better than that of control group at 6 months after treatment ( P <0.05) .
CONCLUSION


Intra-articular and extra-articular injection of PRP could relieve pain symptoms and improve function of knee joint with higher safety, although the short-term effect is not significantly different from traditional treatment, its medium-long-term effect is stable. It is a safe and effective method for the treatment of knee osteoarthritis.",2020,"There was no significant difference in Lysholm score between two groups at 1 month after treatment ( P >0.05), while Lysholm score in observation group was better than that of control group at 6 months after treatment ( P <0.05) .
","['From January to December 2017, 48 patients with KOA', '8 males and 16 females with an average of (58.04±7.87) years old ranging from 43 to 68 years old, the courses of disease ranged from 1 to 8 years with an average of (4.69±1.96) years, the body mass index (BMI) was (24.53±5.26', 'patients with knee osteoarthritis (KOA', 'knee osteoarthritis', '7 males and 17 females with an average of (60.54±8.93) years old ranging from 47 to 72 years old, the courses of disease ranged from 1.5 to 9 years with an average of (5.27±1.68) years, BMI was (23.47±4.62) kg/m 2 ']","['intra-articular injection of PRP (2 ml) and extra-articular injection of PRP', 'platelet-rich plasma (PRP) intra-articular and extra-articular injection', 'intra-articular injection of sodium hyaluronate (20 mg), extra-articular injection of analgesic drug', 'PRP']","['pain symptoms', 'VAS score and Lysholm score', 'VAS score', 'Lysholm score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0021488', 'cui_str': 'Intra-Articular Injections'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0205135', 'cui_str': 'Extra-articular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C0087000', 'cui_str': 'Sodium Hyaluronate'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",48.0,0.0135801,"There was no significant difference in Lysholm score between two groups at 1 month after treatment ( P >0.05), while Lysholm score in observation group was better than that of control group at 6 months after treatment ( P <0.05) .
","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Du', 'Affiliation': 'Department of Rehabilitation, the Sixth Medical Center of PLA General Hospital, Beijing 100048, China.'}, {'ForeName': 'Hong-Peng', 'Initials': 'HP', 'LastName': 'Cui', 'Affiliation': 'Department of Rehabilitation, the Sixth Medical Center of PLA General Hospital, Beijing 100048, China.'}, {'ForeName': 'Ben-Sheng', 'Initials': 'BS', 'LastName': 'Fu', 'Affiliation': 'Department of Rehabilitation, the Sixth Medical Center of PLA General Hospital, Beijing 100048, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation, the Sixth Medical Center of PLA General Hospital, Beijing 100048, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation, the Sixth Medical Center of PLA General Hospital, Beijing 100048, China.'}, {'ForeName': 'Yu-Xian', 'Initials': 'YX', 'LastName': 'Zhong', 'Affiliation': 'Department of Rehabilitation, the Sixth Medical Center of PLA General Hospital, Beijing 100048, China.'}, {'ForeName': 'Yan-Han', 'Initials': 'YH', 'LastName': 'Dong', 'Affiliation': 'Department of Rehabilitation, the Sixth Medical Center of PLA General Hospital, Beijing 100048, China.'}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2020.03.004']
550,26569059,Validation of the Predictive Value of Modeled Human Chorionic Gonadotrophin Residual Production in Low-Risk Gestational Trophoblastic Neoplasia Patients Treated in NRG Oncology/Gynecologic Oncology Group-174 Phase III Trial.,"OBJECTIVES


In low-risk gestational trophoblastic neoplasia, chemotherapy effect is monitored and adjusted with serum human chorionic gonadotrophin (hCG) levels. Mathematical modeling of hCG kinetics may allow prediction of methotrexate (MTX) resistance, with production parameter ""hCGres."" This approach was evaluated using the GOG-174 (NRG Oncology/Gynecologic Oncology Group-174) trial database, in which weekly MTX (arm 1) was compared with dactinomycin (arm 2).
METHODS


Database (210 patients, including 78 with resistance) was split into 2 sets. A 126-patient training set was initially used to estimate model parameters. Patient hCG kinetics from days 7 to 45 were fit to: [hCG(time)] = hCG7 * exp(-k * time) + hCGres, where hCGres is residual hCG tumor production, hCG7 is the initial hCG level, and k is the elimination rate constant. Receiver operating characteristic (ROC) analyses defined putative hCGRes predictor of resistance. An 84-patient test set was used to assess prediction validity.
RESULTS


The hCGres was predictive of outcome in both arms, with no impact of treatment arm on unexplained variability of kinetic parameter estimates. The best hCGres cutoffs to discriminate resistant versus sensitive patients were 7.7 and 74.0 IU/L in arms 1 and 2, respectively. By combining them, 2 predictive groups were defined (ROC area under the curve, 0.82; sensitivity, 93.8%; specificity, 70.5%). The predictive value of hCGres-based groups regarding resistance was reproducible in test set (ROC area under the curve, 0.81; sensitivity, 88.9%; specificity, 73.1%). Both hCGres and treatment arm were associated with resistance by logistic regression analysis.
CONCLUSIONS


The early predictive value of the modeled kinetic parameter hCGres regarding resistance seems promising in the GOG-174 study. This is the second positive evaluation of this approach. Prospective validation is warranted.",2016,"The hCGres was predictive of outcome in both arms, with no impact of treatment arm on unexplained variability of kinetic parameter estimates.","['Low-Risk Gestational Trophoblastic Neoplasia Patients Treated in NRG Oncology/Gynecologic Oncology Group-174 Phase III Trial', 'Database (210 patients, including 78 with resistance']","['dactinomycin', 'methotrexate (MTX', 'Modeled Human Chorionic Gonadotrophin Residual Production', 'MTX', 'hCG7']",['serum human chorionic gonadotrophin (hCG) levels'],"[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C1135868', 'cui_str': 'Gestational Trophoblastic Neoplasms'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0010934', 'cui_str': 'Dactinomycin'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0033268'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement (procedure)'}]",,0.0675011,"The hCGres was predictive of outcome in both arms, with no impact of treatment arm on unexplained variability of kinetic parameter estimates.","[{'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'You', 'Affiliation': '*EMR UBCL/HCL 3738, Université Claude Bernard Lyon-1, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), Centre de Référence des Maladie Trophoblastiques, Hospices Civils de Lyon, Lyon, France; †NRG Oncology Statistics and Data Management Center, Roswell Park Cancer Institute, Buffalo, NY; and ‡Department of Oncology, Princess Margaret Hospital; and §Department of Gynecology/Oncology, Toronto-Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': ''}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Hénin', 'Affiliation': ''}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Oza', 'Affiliation': ''}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Osborne', 'Affiliation': ''}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1097/IGC.0000000000000581']
551,32229139,The short-term effect of dark chocolate flavanols on cognition in older adults: A randomized controlled trial (FlaSeCo).,"BACKGROUND


Cocoa flavanols in the diet have had positive effects on cognition, blood lipid levels, and glucose metabolism.
METHODS


Cognitively healthy older adults aged 65-75 years were recruited for an eight-week randomized, double-blind controlled trial to investigate the effectiveness of cocoa flavanols on cognitive functions. At baseline, nutrient and polyphenol intakes from diet were assessed with three-day food diaries. The intervention group received 50 g dark chocolate containing 410 mg of flavanols per day, and the control group 50 g dark chocolate containing 86 mg of flavanols per day, for eight weeks. Cognition was assessed with Verbal Fluency (VF) and the Trail Making Test (TMT) A and B as the main outcome measures. Changes in blood lipids and glucose were also measured.
RESULTS


The older adults participating numbered 100 (63% women), mean 69 y (range 65 to 74). They were highly educated with a mean 14.9 years of education (SD 3.6). No differences in changes in cognition were seen between groups. The mean change (± SEs) in the time to complete the TMT A and B in the intervention group was -4.6 s (-7.1 to -2.1) and -16.1 s (-29.1 to -3.1), and in the controls -4.4 s (-7.0 to -1.9) and -12.5 s (-22.8 to -2.1)(TMT A p = 0.93; TMT B p = 0.66). No difference was apparent in the changes in blood lipids, glucose levels, or body weight between the groups.
CONCLUSIONS


The healthy older adults showed no effect from the eight-week intake of dark chocolate flavanols on cognition.",2020,The healthy older adults showed no effect from the eight-week intake of dark chocolate flavanols on cognition.,"['older adults', 'healthy older adults', 'older adults participating numbered 100 (63% women), mean 69 y (range 65 to 74', 'Cognitively healthy older adults aged 65-75\u202fyears', 'They were highly educated with a mean 14.9\u202fyears of education (SD 3.6']","['cocoa flavanols', '50\u202fg dark chocolate containing 410\u202fmg of flavanols per day, and the control group 50\u202fg dark chocolate containing 86\u202fmg of flavanols', 'dark chocolate flavanols', '2.1)(TMT']","['mean change (± SEs', 'blood lipids and glucose', 'Verbal Fluency (VF) and the Trail Making Test (TMT', 'cognitive functions', 'changes in cognition', 'cognition, blood lipid levels, and glucose metabolism', 'blood lipids, glucose levels, or body weight']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0857756', 'cui_str': 'Highly educated'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}]","[{'cui': 'C4521844', 'cui_str': 'Cocoa'}, {'cui': 'C3853217', 'cui_str': 'Dark chocolate (substance)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0040604', 'cui_str': 'Trail Making Test'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",,0.0700198,The healthy older adults showed no effect from the eight-week intake of dark chocolate flavanols on cognition.,"[{'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Suominen', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Finland; Society for Gerontological Nutrition, Finland. Electronic address: merja.suominen@gery.fi.'}, {'ForeName': 'M M L', 'Initials': 'MML', 'LastName': 'Laaksonen', 'Affiliation': 'Fazer Group, Finland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Salmenius-Suominen', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Finland; Society for Gerontological Nutrition, Finland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kautiainen', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Finland.'}, {'ForeName': 'S-M', 'Initials': 'SM', 'LastName': 'Hongisto', 'Affiliation': 'Fazer Group, Finland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Tuukkanen', 'Affiliation': 'Fazer Group, Finland.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Jyväkorpi', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Finland.'}, {'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Pitkälä', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Finland.'}]",Experimental gerontology,['10.1016/j.exger.2020.110933']
552,32134713,Effects of resveratrol or estradiol on postexercise endothelial function in estrogen-deficient postmenopausal women.,"Regular exercise enhances endothelial function in older men, but not consistently in estrogen-deficient postmenopausal women. Estradiol treatment improves basal endothelial function and restores improvements in endothelial function (flow-mediated dilation, FMD) to aerobic exercise training in postmenopausal women; however, estradiol treatment is controversial. Resveratrol, an estrogen receptor ligand, enhances exercise training effects on cardiovascular function and nitric oxide (NO) release in animal models, but impairs exercise training effects in men. We conducted a randomized cross-over, double-blinded, placebo-controlled pilot study to determine whether acute (single dose) resveratrol (250-mg tablet) or estradiol (0.05 mg/day transdermal patch) treatment enhances FMD at rest and after a single bout of moderate-intensity aerobic exercise in healthy estrogen-deficient postmenopausal women ( n  = 15, 58.1 ± 3.2 yr). FMD was measured before and after (30, 60, and 120 min) a 40-min bout of moderate-intensity treadmill exercise (60-75% peak heart rate) under the respective conditions (separated by 1-2 wk). FMD was higher ( P  < 0.05) before exercise and at all post-exercise time points in the resveratrol and estradiol conditions compared to placebo. FMD was increased from baseline by 120 min postexercise in the estradiol condition ( P  < 0.001), but not resveratrol or PL conditions. Consistent with our previous findings, estradiol also enhances endothelial function in response to acute endurance exercise. Although resveratrol improved basal FMD, there was no apparent enhancement of FMD to acute exercise and, therefore, may not act as an estradiol mimetic. NEW & NOTEWORTHY  The benefits of endurance exercise training on endothelial function are diminished in estrogen-deficient postmenopausal women, but estradiol treatment appears to restore improvements in endothelial function in this group. We show that basal endothelial function is enhanced with both acute estradiol and resveratrol treatments in estrogen-deficient postmenopausal women, but endothelial function is only enhanced following acute endurance exercise with estradiol treatment.",2020,"FMD was increased from baseline by 120 min post-exercise in the estradiol condition (P<0.001), but not resveratrol or PL conditions.","['postmenopausal women', 'estrogen-deficient postmenopausal women', 'older men', 'men', 'healthy estrogen-deficient postmenopausal women (n=15, 58.1 ± 3.2 yr']","['moderate intensity aerobic exercise', 'aerobic exercise training', 'estradiol', 'placebo', 'Regular exercise', 'resveratrol or estradiol', '40-min bout of moderate-intensity treadmill exercise', 'Estradiol']","['FMD', 'cardiovascular function and nitric oxide (NO) release', 'endothelial function (flow-mediated dilation, FMD', 'basal FMD', 'basal endothelial function', 'endothelial function']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517687', 'cui_str': '3.2'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}, {'cui': 'C2930481', 'cui_str': 'cis-Resveratrol'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}]",,0.159345,"FMD was increased from baseline by 120 min post-exercise in the estradiol condition (P<0.001), but not resveratrol or PL conditions.","[{'ForeName': 'Cemal', 'Initials': 'C', 'LastName': 'Ozemek', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Kerry L', 'Initials': 'KL', 'LastName': 'Hildreth', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Blatchford', 'Affiliation': 'Veterans Affairs Eastern Colorado Geriatric Research, Education and Clinical Center, Denver, Colorado.'}, {'ForeName': 'K Joseph', 'Initials': 'KJ', 'LastName': 'Hurt', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Bok', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Douglas R', 'Initials': 'DR', 'LastName': 'Seals', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, Colorado.'}, {'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Kohrt', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Kerrie L', 'Initials': 'KL', 'LastName': 'Moreau', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00488.2019']
553,32016532,Methylnaltrexone for the treatment of opioid-induced constipation and gastrointestinal stasis in intensive care patients. Results from the MOTION trial.,"PURPOSE


Constipation can be a significant problem in critically unwell patients, associated with detrimental outcomes. Opioids are thought to contribute to the mechanism of bowel dysfunction. We tested if methylnaltrexone, a pure peripheral mu-opioid receptor antagonist, could reverse opioid-induced constipation.
METHODS


The MOTION trial is a multi-centre, double blind, randomised placebo-controlled trial to investigate whether methylnaltrexone alleviates opioid-induced constipation (OIC) in critical care patients. Eligibility criteria included adult ICU patients who were mechanically ventilated, receiving opioids and were constipated (had not opened bowels for a minimum 48 h) despite prior administration of regular laxatives as per local bowel management protocol. The primary outcome was time to significant rescue-free laxation. Secondary outcomes included gastric residual volume, tolerance of enteral feeds, requirement for rescue laxatives, requirement for prokinetics, average number of bowel movements per day, escalation of opioid dose due to antagonism/reversal of analgesia, incidence of ventilator-associated pneumonia, incidence of diarrhoea and Clostridium difficile infection and finally 28 day, ICU and hospital mortality.
RESULTS


A total of 84 patients were enrolled and randomized (41 to methylnaltrexone and 43 to placebo). The baseline demographic characteristics of the two groups were generally well balanced. There was no significant difference in time to rescue-free laxation between the groups (Hazard ratio 1.42, 95% CI 0.82-2.46, p = 0.22). There were no significant differences in the majority of secondary outcomes, particularly days 1-3. However, during days 4-28, there were fewer median number of bowel movements per day in the methylnaltrexone group, (p = 0.01) and a greater incidence of diarrhoea in the placebo group (p = 0.02). There was a marked difference in mortality between the groups, with ten deaths in the methylnaltrexone group and two in the placebo group during days 4-28 (p = 0.007).
CONCLUSION


We found no evidence to support the addition of methylnaltrexone to regular laxatives for the treatment of opioid-induced constipation in critically ill patients; however, the confidence interval was wide and a clinically important difference cannot be excluded.",2020,"There was no significant difference in time to rescue-free laxation between the groups (Hazard ratio 1.42, 95% CI 0.82-2.46, p = 0.22).","['critical care patients', '84 patients were enrolled and randomized (41 to', 'intensive care patients', 'Eligibility criteria included adult ICU patients who were mechanically ventilated, receiving opioids and were constipated (had not opened bowels for a minimum 48\xa0h) despite prior administration of regular laxatives as per local bowel management protocol']","['methylnaltrexone and 43 to placebo', 'methylnaltrexone alleviates opioid-induced constipation (OIC', 'Methylnaltrexone', 'placebo', 'methylnaltrexone']","['median number of bowel movements', 'time to rescue-free laxation', 'constipation and gastrointestinal stasis', 'mortality', 'gastric residual volume, tolerance of enteral feeds, requirement for rescue laxatives, requirement for prokinetics, average number of bowel movements per day, escalation of opioid dose due to antagonism/reversal of analgesia, incidence of ventilator-associated pneumonia, incidence of diarrhoea and Clostridium difficile infection and finally 28\xa0day, ICU and hospital mortality', 'incidence of diarrhoea', 'time to significant rescue-free laxation']","[{'cui': 'C0010337', 'cui_str': 'Critical Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085559'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0282090', 'cui_str': 'Laxatives'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0150155', 'cui_str': 'Bowel management'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0066411', 'cui_str': 'methylnaltrexone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0333138', 'cui_str': 'Stasis (morphologic abnormality)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C3665864', 'cui_str': 'Gastric residuals'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0282090', 'cui_str': 'Laxatives'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0343386', 'cui_str': 'Clostridium difficile infection (disorder)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",84.0,0.631063,"There was no significant difference in time to rescue-free laxation between the groups (Hazard ratio 1.42, 95% CI 0.82-2.46, p = 0.22).","[{'ForeName': 'Parind B', 'Initials': 'PB', 'LastName': 'Patel', 'Affiliation': 'Centre for Perioperative Medicine and Critical Care Research, Imperial College Healthcare NHS Trust, London, UK. parind.patel@nhs.net.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Brett', 'Affiliation': 'Centre for Perioperative Medicine and Critical Care Research, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': ""O'Callaghan"", 'Affiliation': 'Centre for Perioperative Medicine and Critical Care Research, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Aisha', 'Initials': 'A', 'LastName': 'Anjum', 'Affiliation': 'Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Cross', 'Affiliation': 'Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Warwick', 'Affiliation': 'Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Gordon', 'Affiliation': 'Centre for Perioperative Medicine and Critical Care Research, Imperial College Healthcare NHS Trust, London, UK.'}]",Intensive care medicine,['10.1007/s00134-019-05913-6']
554,31935774,Pelvic Floor Muscle Training in Female Athletes: A Randomized Controlled Pilot Study.,"The aim of this study was to investigate the effects of pelvic floor muscles training in elite female volleyball athletes and whether it is an effective therapy for stress urinary incontinence. Fourteen athletes, both continent and incontinent, between 18 and 30 years of age, were randomly assigned to an experimental group or a control group. The experimental group received a protocol for pelvic floor muscle training for 4 months. This consisted of three phases: awareness/stabilization, strength training and power. The control group was not subject to any intervention during the same period. Measures were collected at the initial and final phase for both groups. Maximum voluntary contractions were evaluated with a perineometer, involuntary urine loss with a Pad test and quality of life with the King's Health Questionnaire. Baseline sociodemographic and anthropometric characteristics were not significantly different. Comparing the two groups, the experimental group improved maximum voluntary pelvic contractions (p<0.001) and reduced urine loss (p=0.025), indicating the existence of significant differences between groups in the variation from the initial and final phases. The percentage of urine loss decreased in the experimental group, from 71.4-42.9%, suggesting that the protocol intervention for 16 weeks may help athletes with stress urinary incontinence.",2020,"Comparing the two groups, the experimental group improved maximum voluntary pelvic contractions (p<0.001) and reduced urine loss (p=0.025), indicating the existence of significant differences between groups in the variation from the initial and final phases.","['elite female volleyball athletes', 'Female Athletes', 'Fourteen athletes, both continent and incontinent, between 18 and 30 years of age']","['protocol for pelvic floor muscle training', 'Pelvic Floor Muscle Training', 'pelvic floor muscles training']","['Maximum voluntary contractions', 'maximum voluntary pelvic contractions', 'percentage of urine loss', 'urine loss', 'Baseline sociodemographic and anthropometric characteristics', ""involuntary urine loss with a Pad test and quality of life with the King's Health Questionnaire""]","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0443192', 'cui_str': 'Continent (qualifier value)'}, {'cui': 'C0231238', 'cui_str': 'Incontinent (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0042037'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0318413,"Comparing the two groups, the experimental group improved maximum voluntary pelvic contractions (p<0.001) and reduced urine loss (p=0.025), indicating the existence of significant differences between groups in the variation from the initial and final phases.","[{'ForeName': 'Telma Filipa', 'Initials': 'TF', 'LastName': 'Pires', 'Affiliation': 'Department of Sports Sciences, University of Trás-os- Montes and Alto Douro, Vila Real, Portugal.'}, {'ForeName': 'Patricia Maria', 'Initials': 'PM', 'LastName': 'Pires', 'Affiliation': 'Higher School of Health, University of Trás-os-Montes and Alto Douro, Vila Real, Portugal.'}, {'ForeName': 'Maria Helena', 'Initials': 'MH', 'LastName': 'Moreira', 'Affiliation': 'Department of Sports, Exercise and Health Sciences, CIDESD, CITAB, University of Trás-os-Montes and Alto Douro, Vila Real, Portugal.'}, {'ForeName': 'Ronaldo Eugênio Calçadas Dias', 'Initials': 'RECD', 'LastName': 'Gabriel', 'Affiliation': 'Department of Sports, Exercise and Health Sciences, CITAB, University of Trás-os-Montes and Alto Douro, Vila Real, Portugal.'}, {'ForeName': 'Paulo Vicente', 'Initials': 'PV', 'LastName': 'João', 'Affiliation': 'Center in Sports Sciences, Health Sciences and Human Development (CIDESD), CreativeLab, University of Trás-os-Montes and Alto Douro (UTAD) Vila Real, Portugal.'}, {'ForeName': 'Sara Alexandra', 'Initials': 'SA', 'LastName': 'Viana', 'Affiliation': 'Higher School of Health, University of Fernando Pessoa, Porto, Portugal.'}, {'ForeName': 'Rui Antunes', 'Initials': 'RA', 'LastName': 'Viana', 'Affiliation': 'Higher School of Health, University of Fernando Pessoa, Porto, Portugal.'}]",International journal of sports medicine,['10.1055/a-1073-7977']
555,31935778,Influence of a Field Hamstring Eccentric Training on Muscle Strength and Flexibility.,"Muscle strength imbalances and poor flexibility are frequently described as risk factors for hamstring injury. Preventive strategies include eccentric exercises, but the influence of field eccentric exercises on these risk factors remains unclear. We investigated the influence of a field hamstring eccentric program on hamstring strength and flexibility. Twenty-seven amateur athletes were randomly assigned to an intervention (n=13) or control group (n=14). In the intervention group, participants were involved in 15 sessions of four eccentric exercises. Peak torque, hamstring-to-quadriceps ratios, passive and active flexibility were analyzed. No significant modifications of strength, passive or active flexibility were observed in the control group (p>0.05). Hamstring eccentric peak torque (+7.1%) and functional hamstring-to-quadriceps ratios (9.3%) were significantly increased (p<0.05) in the intervention group, but not concentric strength (p<0.05). Passive straight leg raise was significantly increased by 11.4° (+12.7%, p<0.001), but not active flexibility (+3.1%, p>0.05). In conclusion, a 6-week eccentric program, including four field exercises for hamstring muscles, is an effective method of improving eccentric strength, functional ratios and, especially, passive flexibility. As this program may be easily implemented in a real-world context, this association of multiple eccentric exercises might be useful in an injury prevention strategy.",2020,"No significant modifications of strength, passive or active flexibility were observed in the control group (p>0.05).",['Twenty-seven amateur athletes'],"['field hamstring eccentric program', 'Field Hamstring Eccentric Training', 'field eccentric exercises']","['functional hamstring-to-quadriceps ratios', 'strength, passive or active flexibility', 'Muscle Strength and Flexibility', 'Passive straight leg raise', 'hamstring strength and flexibility', 'Peak torque, hamstring-to-quadriceps ratios, passive and active flexibility', 'Hamstring eccentric peak torque', 'active flexibility']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0422926', 'cui_str': 'Straight leg raise test response'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}]",,0.0100346,"No significant modifications of strength, passive or active flexibility were observed in the control group (p>0.05).","[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Delvaux', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, IOC Research Center for prevention and athlete health, FIFA Medical Center of Excellence, FIMS Collaborating Center of Sports Medicine, University and CHU of Liege, Liege, Belgium.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Schwartz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, IOC Research Center for prevention and athlete health, FIFA Medical Center of Excellence, FIMS Collaborating Center of Sports Medicine, University and CHU of Liege, Liege, Belgium.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Decréquy', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, IOC Research Center for prevention and athlete health, FIFA Medical Center of Excellence, FIMS Collaborating Center of Sports Medicine, University and CHU of Liege, Liege, Belgium.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Devalckeneer', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, IOC Research Center for prevention and athlete health, FIFA Medical Center of Excellence, FIMS Collaborating Center of Sports Medicine, University and CHU of Liege, Liege, Belgium.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Paulus', 'Affiliation': 'Laboratory of Human Motion Analysis, University of Liege, Liege, Belgium.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bornheim', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, IOC Research Center for prevention and athlete health, FIFA Medical Center of Excellence, FIMS Collaborating Center of Sports Medicine, University and CHU of Liege, Liege, Belgium.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Kaux', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, IOC Research Center for prevention and athlete health, FIFA Medical Center of Excellence, FIMS Collaborating Center of Sports Medicine, University and CHU of Liege, Liege, Belgium.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Croisier', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, IOC Research Center for prevention and athlete health, FIFA Medical Center of Excellence, FIMS Collaborating Center of Sports Medicine, University and CHU of Liege, Liege, Belgium.'}]",International journal of sports medicine,['10.1055/a-1073-7809']
556,31935779,"Effectiveness of Multi-activity, High-intensity Interval Training in School-aged Children.","The present study aimed to evaluate the effectiveness of a school-based multi-activity HIIT on aerobic fitness (AF) and hemodynamic parameters in children. 46 students were randomized into an intervention group (INT) (N=22) and a control group (CON) (N=24). Throughout a 3-month intervention period, both INT and CON participated in the regular physical education classes (PE) twice a week. Only INT received an instructed HIIT during the first 20 min of the PE. In addition to an AF-test, peripheral (pBP) and central (cBP) blood pressure, augmentation pressure (AP), and aortic pulse wave velocity (aPWV) were assessed. Significant differences in intervention effects in favor of INT were detected for AF (7.73, P=0.007), peripheral systolic BP (-6.13 mmHg, P=0.038), central systolic BP (-5.19 mmHg, P = 0.041), AP (-2.02 mmHg, P=0.013), and aPWV (-0.19 m/sec, P=0.031). The regular HITT intervention showed beneficial effects on AF, BP, and parameters of vascular stiffness already in children.",2020,"Significant differences in intervention effects in favor of INT were detected for AF (7.73, P=0.007), peripheral systolic BP (-6.13 mmHg, P=0.038), central systolic BP (-5.19 mmHg, P = 0.041), AP (-2.02 mmHg, P=0.013), and aPWV (-0.19 m/sec, P=0.031).","['46 students', 'School-aged Children', 'children']","['intervention group (INT', 'INT and CON', 'Multi-activity, High-intensity Interval Training', 'control group (CON', 'school-based multi-activity HIIT']","['AF-test, peripheral (pBP) and central (cBP) blood pressure, augmentation pressure (AP), and aortic pulse wave velocity (aPWV', 'central systolic BP', 'peripheral systolic BP', 'aPWV', 'AF, BP, and parameters of vascular stiffness', 'aerobic fitness (AF) and hemodynamic parameters']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3178781', 'cui_str': 'Vascular Stiffness'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",,0.0236633,"Significant differences in intervention effects in favor of INT were detected for AF (7.73, P=0.007), peripheral systolic BP (-6.13 mmHg, P=0.038), central systolic BP (-5.19 mmHg, P = 0.041), AP (-2.02 mmHg, P=0.013), and aPWV (-0.19 m/sec, P=0.031).","[{'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Ketelhut', 'Affiliation': 'Martin-Luther-Universität Halle-Wittenberg, Institute of Sport Science, Halle (Saale), Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kircher', 'Affiliation': 'SRH Hochschule für Gesundheit Gera, Medical Education, Gera, Germany.'}, {'ForeName': 'Sebastian R', 'Initials': 'SR', 'LastName': 'Ketelhut', 'Affiliation': 'Charit -Universitätsmedizin Berlin, Institute for Social Medicine, Epidemiology and Health Economics, Berlin, Germany.'}, {'ForeName': 'Emanuel', 'Initials': 'E', 'LastName': 'Wehlan', 'Affiliation': 'Humboldt-Universität zu Berlin, Department of Sport Sciences, Berlin, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Ketelhut', 'Affiliation': 'MSB Medical School Berlin, Natural Sciences, Berlin, Germany.'}]",International journal of sports medicine,['10.1055/a-1068-9331']
557,32229229,Effectiveness and Safety of Supervised Home-based Physical Training in Patients With COPD on Long-Term Home Oxygen Therapy: A Randomized Trial.,"BACKGROUND


Patients with COPD in advanced stages who need long-term home oxygen therapy (LTHOT) have difficulty participating in outpatient pulmonary rehabilitation (PR) programs. This difficulty is due to the severity of their disease, limitations involving transportation and mobility, high costs, and issues related to patients' safety and individual needs. Unsupervised home-based physical training (PT) is frequently used.
RESEARCH QUESTION


The main objective of this study was to investigate the effectiveness of a supervised home-based PT program on exercise capacity and other outcomes in patients with COPD receiving LTHOT.
STUDY DESIGN AND METHODS


In a randomized clinical trial, patients with COPD who were on LTHOT were allocated into two groups: the supervised physical training (PT) group, consisting of patients who received home-based supervised muscle strength and endurance training in twice-weekly 60-min sessions for 12 weeks; and the unsupervised activity booklet group, consisting of patients who received a booklet advising them to perform exercise twice a week for 12 weeks. All participants were assessed prior to and following the intervention in terms of exercise capacity (6-min step-test and the 1-min sit-to-stand test); dyspnea (Medical Research Council scale); fatigue (Brazilian Portuguese version of the Fatigue Severity Scale); and health status (COPD Assessment Test).
RESULTS


A total of 44 patients were assessed (mean age, 70 ± 8 years; FEV 1 , 33 ± 14% predicted) (PT group, n = 22; booklet group, n = 22). Only the PT group patients presented significant improvement in the 6-min step-test (21 ± 9 vs 14 ± 1; P = 0.001), Medical Research Council scale (3.3 ± 1.0 vs 3.9 ± 0.9; P = 0.013), Brazilian Portuguese version of the Fatigue Severity Scale (5.0 ± 1.4 vs 5.2 ± 1.3; P = .015), and COPD Assessment Test (21 ± 8 vs 26 ± 6; P =0.001). No adverse effects were observed.
INTERPRETATION


Supervised home-based PT was effective and safe in improving exercise capacity, dyspnea, fatigue, and health status in patients with COPD on LTHOT.
CLINICAL TRIAL REGISTRATION


Brazilian Registry of Clinical Trials-RBR-535smn.",2020,"Supervised home-based PT was effective and safe in improving exercise capacity, dyspnea, fatigue and health status in patients with COPD on LTHOT.","['44 patients were assessed (70±8 years, FEV 1 : 33±14%predicted) (PTG, n=22; BG, n=22', 'patients with COPD', 'patients with COPD on LTHOT', 'Patients with chronic obstructive pulmonary disease (COPD) in advanced disease stage who need long-term home oxygen therapy (LTHOT) have difficulty participating in outpatient pulmonary rehabilitation (PR) programs']","['supervised home-based PT program', 'THERAPY', 'supervised physical training group (PTG), consisting of patients who received home-based supervised muscle strength and endurance training in twice-weekly 60-minute sessions for 12 weeks; and unsupervised activity booklet group (BG), consisting of patients who received a booklet advising them to perform exercise', 'Unsupervised home-based physical training (PT']","['exercise capacity (6-Minute Step-Test (6MST) and the 1-Minute Sit-to-Stand Test [STST]); dyspnea (Medical Research Council scale [MRC]); fatigue (Fatigue Severity Scale [FSS-BR]); and health status (COPD Assessment Test [CAT', 'FSS-BR', 'adverse effects', 'MRC', 'exercise capacity, dyspnea, fatigue and health status', '6MST']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1960973', 'cui_str': 'Home oxygen therapy (procedure)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0222045'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",44.0,0.0462586,"Supervised home-based PT was effective and safe in improving exercise capacity, dyspnea, fatigue and health status in patients with COPD on LTHOT.","[{'ForeName': 'Demetria', 'Initials': 'D', 'LastName': 'Kovelis', 'Affiliation': 'Department of Physical Therapy, UniDomBosco University, Curitiba, Paraná, Brazil. Electronic address: demetriakovelis@gmail.com.'}, {'ForeName': 'Anna R S', 'Initials': 'ARS', 'LastName': 'Gomes', 'Affiliation': 'Department of Prevention and Rehabilitation in Physical Therapy, Masters/Doctoral Program in Physical Education, Federal University of Paraná, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Mazzarin', 'Affiliation': 'Cajuru University Hospital, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Samia K', 'Initials': 'SK', 'LastName': 'Biazim', 'Affiliation': 'Cajuru University Hospital, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Pitta', 'Affiliation': 'Department of Physical Therapy, State University of Londrina, Londrina, Paraná, Brazil.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Valderramas', 'Affiliation': 'Department of Prevention and Rehabilitation in Physical Therapy, Masters/Doctoral Program in Internal Medicine and Health Sciences, Federal University of Paraná, Curitiba, Paraná, Brazil.'}]",Chest,['10.1016/j.chest.2020.02.063']
558,32229754,Olanzapine for the Prevention of Postdischarge Nausea and Vomiting after Ambulatory Surgery: A Randomized Controlled Trial.,"BACKGROUND


Postdischarge nausea and vomiting after ambulatory surgery is a common problem that is not adequately addressed in current practice. This prospective, randomized, double-blind, parallel-group, placebo-controlled study was designed to test the hypothesis that oral olanzapine is superior to placebo at preventing postdischarge nausea and vomiting.
METHODS


In a single-center, double-blind, randomized, placebo-controlled trial, the authors compared a single preoperative dose of olanzapine 10 mg to placebo, in adult female patients 50 years old or less, undergoing ambulatory gynecologic or plastic surgery with general anesthesia. All patients received standard antiemetic prophylaxis with dexamethasone and ondansetron. The primary composite outcome was nausea and/or vomiting in the 24 h after discharge. Secondary outcomes included severe nausea, vomiting, and side effects.
RESULTS


A total of 140 patients were randomized and evaluable. The primary outcome occurred in 26 of 69 patients (38%) in the placebo group and in 10 of 71 patients (14%) in the olanzapine group (relative risk, 0.37; 95% CI, 0.20 to 0.72; P = 0.003). Severe nausea occurred in 14 patients (20%) in the placebo group and 4 patients (6%) in the olanzapine group (relative risk, 0.28; 95% CI, 0.10 to 0.80). Vomiting occurred in eight patients (12%) in the placebo group and two patients (3%) in the olanzapine group (relative risk, 0.24; 95% CI, 0.05 to 1.10). The median score for sedation (scale 0 to 10, with 10 being highest) in the 24 h after discharge was 4 (interquartile range, 2 to 7) in the placebo group and 6 (interquartile range, 3 to 8) in the olanzapine group (P = 0.023).
CONCLUSIONS


When combined with ondansetron and dexamethasone, the addition of olanzapine relative to placebo decreased the risk of nausea and/or vomiting in the 24 hafter discharge from ambulatory surgery by about 60% with a slight increase in reported sedation.",2020,"Vomiting occurred in eight patients (12%) in the placebo group and two patients (3%) in the olanzapine group (relative risk, 0.24; 95% CI, 0.05 to 1.10).","['140 patients were randomized and evaluable', 'after Ambulatory Surgery', 'adult female patients 50 years old or less, undergoing ambulatory gynecologic or plastic surgery with general anesthesia']","['dexamethasone and ondansetron', 'Olanzapine', 'placebo', 'olanzapine 10 mg to placebo', 'olanzapine', 'ondansetron and dexamethasone']","['Severe nausea', 'Postdischarge Nausea and Vomiting', 'nausea and vomiting', 'postdischarge nausea and vomiting', 'Vomiting', 'risk of nausea and/or vomiting', 'median score for sedation', 'severe nausea, vomiting, and side effects', 'nausea and/or vomiting']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory Surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0038911', 'cui_str': 'Surgery, Plastic'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0988260', 'cui_str': 'olanzapine 10 MG'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",140.0,0.74613,"Vomiting occurred in eight patients (12%) in the placebo group and two patients (3%) in the olanzapine group (relative risk, 0.24; 95% CI, 0.05 to 1.10).","[{'ForeName': 'Jaime B', 'Initials': 'JB', 'LastName': 'Hyman', 'Affiliation': ""From the Department of Anesthesiology, Perioperative and Pain Medicine (J.B.H., C.P., B.C., M.H., S.D.) Department of Population Health Science and Policy (H.-M.L.) Division of Gynecology, Department of Obstetrics, Gynecology and Reproductive Science (L.R., R.L.B.G., V.P., C.A.-W.) Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Blavatnik Family Women's Health Research Institute (S.V.B.) Division of Plastic and Reconstructive Surgery, Department of Surgery (P.J.T.), Icahn School of Medicine at Mount Sinai, New York, New York Suzanne Fenske, M.D., P.C., Brookville, New York (S.S.F.) Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Boston, Massachusetts (S.B.P.).""}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Hung-Mo', 'Initials': 'HM', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Cole', 'Affiliation': ''}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Rosen', 'Affiliation': ''}, {'ForeName': 'Suzanne S', 'Initials': 'SS', 'LastName': 'Fenske', 'Affiliation': ''}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Barr Grzesh', 'Affiliation': ''}, {'ForeName': 'Stephanie V', 'Initials': 'SV', 'LastName': 'Blank', 'Affiliation': ''}, {'ForeName': 'Sylvie B', 'Initials': 'SB', 'LastName': 'Polsky', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hartnett', 'Affiliation': ''}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Taub', 'Affiliation': ''}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Palvia', 'Affiliation': ''}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'DeMaria', 'Affiliation': ''}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Ascher-Walsh', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003286']
559,32233251,[Clinical study on the control of intra-articular hemorrhage by tranexamic acid after shoulder arthroscopy].,"OBJECTIVE


To explore clinical effects of tranexamic acid on postoperative intra-articular hemorrhage after shoulder arthroscopy.
METHODS


From February to July 2018, 60 patients with rotator cuff tears treated by shoulder arthroscopy were randomly divided into observation group and control group, 30 cases in each group. In observation group, there were 6 males and 24 females; aged from 55 to 70 years old with an average age of (62.3±5.5) years; the courses of disease ranged from 2 to 36 months with an average of (11.7±1.7) months; received 0.5 g tranexamic acid (1 g of tranexamic acid was diluted with normal saline to 20 ml) in each articular cavity and subacromial space after operation. In control group, there were 5 males and 25 females; aged from 56 to 72 years old with an average of (63.4±5.8) years old; the courses of disease ranged from 4 to 36 months with an average of (10.8±1.4) months; 10 ml of normal saline was injected into joint cavity and subacromial space. Hemoglobin values between two groups before and after operation at 1 day were recorded, circumference of shoulder joint was measured preoperatively and the 1st and 7th days after operation, and circumference difference of shoulder joint was recorded. Complications such as subcutaneous blood stasis and DVT were recorded.
RESULTS


There was no significant difference in hemoglobin values between two groups before and after operation at 1 day ( P >0.05) . On the first day after surgery, peripheral diameter of shoulder joint in observation group [(32.9±0.3) cm ] was significantly lower than that in control group [(35.1±0.5) cm ], and the circumference difference of shoulder joint in observation group [(8.7±0.4) mm ] was also significantly lower than that in control group [(12.3±0.5) mm ], the difference was statistically significant ( P <0.05) . However, there was no significant difference in circumference of shoulder joint and the difference in circumference of shoulder joint between two groups on the 7th day after operation ( P >0.05) . Two patients in observation group occurred subcutaneous ecchymosis, while 6 patients occurred in control group, but without statistical difference between two groups ( P >0.05) .
CONCLUSION


Subacromial and articular injection of tranexamic acid could significantly reduce early swelling of soft tissue after arthroscopic shoulder surgery, and it has better safety.",2020,"Subacromial and articular injection of tranexamic acid could significantly reduce early swelling of soft tissue after arthroscopic shoulder surgery, and it has better safety.","['5 males and 25 females; aged from 56 to 72 years old with an average of (63.4±5.8) years old; the courses of disease ranged from 4 to 36 months with an average of (10.8±1.4) months; 10 ml of', 'after shoulder arthroscopy', '6 males and 24 females; aged from 55 to 70 years old with an average age of (62.3±5.5) years; the courses of disease ranged from 2 to 36 months with an average of (11.7±1.7) months; received 0.5 g', 'From February to July 2018', '60 patients with rotator cuff tears treated by shoulder arthroscopy']","['tranexamic acid', 'normal saline', 'tranexamic acid was diluted with normal saline to 20 ml) in each articular cavity and subacromial space after operation']","['circumference difference of shoulder joint', 'hemoglobin values', 'Hemoglobin values', 'circumference of shoulder joint', 'early swelling of soft tissue', 'postoperative intra-articular hemorrhage', 'peripheral diameter of shoulder joint', 'subcutaneous blood stasis and DVT', 'subcutaneous ecchymosis']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0559702', 'cui_str': 'Arthroscopy of shoulder'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0263912', 'cui_str': 'Rotator Cuff Tears'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]","[{'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0037009', 'cui_str': 'Glenohumeral Joint'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0005768'}, {'cui': 'C0333138', 'cui_str': 'Stasis (morphologic abnormality)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}]",60.0,0.0190624,"Subacromial and articular injection of tranexamic acid could significantly reduce early swelling of soft tissue after arthroscopic shoulder surgery, and it has better safety.","[{'ForeName': 'Hua-Li', 'Initials': 'HL', 'LastName': 'Gao', 'Affiliation': 'Department of Orthopaedics of Joint Diseases, Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200052, China.'}, {'ForeName': 'Jie-Chao', 'Initials': 'JC', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedics of Joint Diseases, Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200052, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Orthopaedics of Joint Diseases, Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200052, China.'}, {'ForeName': 'Wei-Tao', 'Initials': 'WT', 'LastName': 'Zhai', 'Affiliation': 'Department of Orthopaedics of Joint Diseases, Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200052, China.'}, {'ForeName': 'Lian-Bo', 'Initials': 'LB', 'LastName': 'Xiao', 'Affiliation': 'Department of Orthopaedics of Joint Diseases, Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200052, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'Department of Orthopaedics of Joint Diseases, Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200052, China.'}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2020.03.010']
560,30913381,"Comparison of nylon-flocked swab and Dacron swab cytology for anal HSIL detection in transgender women and gay, bisexual, and other men who have sex with men.","BACKGROUND


An anal histological high-grade squamous intraepithelial lesion (hHSIL) is an anal cancer precursor. Experts recommend Dacron swab anal cytology as a primary screen for anal hHSILs, especially among human immunodeficiency virus-infected and -uninfected men who have sex with men (MSM). Studies have shown that Dacron cytology inaccurately predicts anal hHSILs and results in unnecessary diagnostic procedures. Nylon-flocked (NF) swabs have been shown to trap pathogens and cells well. Thus, this study compared test characteristics of anal cytology using NF and Dacron swab collection protocols to predict anal hHSILs.
METHODS


A single-visit, randomized clinical trial compared NF and Dacron swab anal cytology specimens to predict high-resolution anoscopy and biopsy-diagnosed anal hHSILs. Data for 326 gay men, bisexual men, other MSM, and male-to-female transgender women contributed descriptive and tabular statistics with which unadjusted and fully adjusted logistic regression models were constructed. The models estimated the odds of hHSILs, test accuracy (area under the curve [AUC]) and sensitivity, and specificity as well as the positive and negative predictive values of abnormal NF and Dacron cytology for predicting hHSILs.
RESULTS


In the fully adjusted model, the sensitivities for NF and Dacron cytology were nearly equal (48% vs 47%), but the specificity was higher with NF cytology (76% vs 69%). Comparisons of the areas under receiver operating characteristic curves showed that NF cytology alone predicted hHSILs better than the covariate model (AUC, 0.69 vs 0.63; P = .02), but NF and Dacron cytology comparisons showed no statistically significant differences (AUC, 0.69 vs 0.67; P = .3).
CONCLUSIONS


NF cytology and Dacron cytology provide modest sensitivity, but NF cytology has higher specificity and accuracy, and this is important for lowering the costs of population-based screening.",2019,"NF and Dacron cytology comparisons showed no statistically significant differences (AUC, 0.69 vs 0.67; P = .3).
","['transgender women and gay, bisexual, and other men who have sex with men', '326 gay men, bisexual men, other MSM, and male-to-female transgender women', 'human immunodeficiency virus-infected and -uninfected men who have sex with men (MSM']","['Dacron swab anal cytology', 'NF and Dacron swab anal cytology specimens', 'Dacron cytology', 'nylon-flocked swab and Dacron swab cytology', 'NF and Dacron swab collection protocols', 'NF cytology and Dacron cytology']","['odds of hHSILs, test accuracy (area under the curve [AUC]) and sensitivity, and specificity', 'sensitivities for NF and Dacron cytology']","[{'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C2129310', 'cui_str': 'Bisexual (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0947693', 'cui_str': 'Dacrons'}, {'cui': 'C1261188', 'cui_str': 'Swab (physical object)'}, {'cui': 'C2939124', 'cui_str': 'Anal (qualifier value)'}, {'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C0028736', 'cui_str': 'Polyamides'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0947693', 'cui_str': 'Dacrons'}, {'cui': 'C0010820', 'cui_str': 'cytology'}]",326.0,0.0522764,"NF and Dacron cytology comparisons showed no statistically significant differences (AUC, 0.69 vs 0.67; P = .3).
","[{'ForeName': 'Dorothy J', 'Initials': 'DJ', 'LastName': 'Wiley', 'Affiliation': 'School of Nursing, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Hilary K', 'Initials': 'HK', 'LastName': 'Hsu', 'Affiliation': 'School of Nursing, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Martha A', 'Initials': 'MA', 'LastName': 'Ganser', 'Affiliation': 'School of Nursing, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Brook', 'Affiliation': 'David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Elashoff', 'Affiliation': 'David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Moran', 'Affiliation': 'School of Nursing, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Young', 'Affiliation': 'Tricore Reference Laboratories, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Joste', 'Affiliation': 'Tricore Reference Laboratories, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Mitsuyasu', 'Affiliation': 'David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Teresa M', 'Initials': 'TM', 'LastName': 'Darragh', 'Affiliation': 'Department of Pathology, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Morris', 'Affiliation': 'Desert AIDS Project, Palm Springs, California.'}, {'ForeName': 'Otoniel M', 'Initials': 'OM', 'LastName': 'Martínez-Maza', 'Affiliation': 'David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Detels', 'Affiliation': 'Jonathan and Karen Fielding School of Public Health, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Jian Yu', 'Initials': 'JY', 'LastName': 'Rao', 'Affiliation': 'David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'Bolan', 'Affiliation': 'Los Angeles LGBT Center, Los Angeles, California.'}, {'ForeName': 'Eric T', 'Initials': 'ET', 'LastName': 'Shigeno', 'Affiliation': 'School of Nursing, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Rodriguez', 'Affiliation': 'School of Nursing, University of California Los Angeles, Los Angeles, California.'}]",Cancer cytopathology,['10.1002/cncy.22114']
561,30880163,"Slow-release naltrexone implant versus oral naltrexone for improving treatment outcomes in people with HIV who are addicted to opioids: a double-blind, placebo-controlled, randomised trial.","BACKGROUND


Untreated opioid addiction in people with HIV is associated with poor HIV treatment outcomes. Slow-release, long-acting, implantable naltrexone might improve these outcomes. Here, we present results of a study aimed to test this hypothesis.
METHODS


We did a 48 week double-blind, double-dummy, placebo-controlled, phase 3, randomised trial with men and women addicted to opioids who were starting antiretroviral therapy (ART) for HIV and whose viral loads were higher than 1000 copies per mL. Participants were seeking treatment at two HIV and two narcology programme centres in Saint Petersburg, Russia, and the surrounding Leningrad region. The Pavlov statistical department created a table with stratification on gender distribution, viral load, and CD4 cell count. We stratified participants according to gender, viral load, and CD4 cells per μL, and randomly assigned (1:1) them to addiction treatment with a naltrexone implant and oral naltrexone placebo (implant group) or oral naltrexone and placebo implant (oral group). The primary outcome was plasma viral load of less than 400 copies per mL at 24 weeks and 48 weeks. We included all randomly assigned participants in outcome analyses (intention to treat). Treatment staff and patients were masked to group assignment. The study is complete and registered at ClinicalTrials.gov, NCT01101815.
FINDINGS


Between July 14, 2011, and April 14, 2014, 238 potential participants were recruited and screened, 35 were excluded for not meeting inclusion criteria, three declined to participate, and 200 were randomly assigned to treatment (100 to each group). At week 24, 38 (38) participants in the implant group and 35 (35%) in the oral group had viral loads less than 400 copies per mL (risk ratio 1·1, 95% CI 0·76-1·56; p=0·77). At week 48, 66 participants in the implant group and 50 in the oral group had viral loads less than 400 copies per mL (risk ratio 1·32, 95% CI 1·04-1·68; p=0·045). There were seven serious adverse events: three deaths in the implant group (one due to heart disease, one trauma, and one AIDS), and four in the oral group (two overdoses, one pancreatic cancer, and one AIDS). The overdose deaths occurred 9-10 months after the last naltrexone dose.
INTERPRETATION


The longer the blockade of opioid effects, the more protection an individual gets from missed ART doses and impulsive behaviours that lead to relapse and poor, even fatal, outcomes. Commercial development of implants could result in a meaningful addition to addiction treatment options.
FUNDING


National Institutes of Health, National Institute on Drug Abuse, Penn Centre for AIDS Research, and Penn Mental Health AIDS Research Centre.",2019,"At week 24, 38 (38) participants in the implant group and 35 (35%) in the oral group had viral loads less than 400 copies per mL (risk ratio 1·1, 95% CI 0·76-1·56; p=0·77).","['people with HIV', 'men and women addicted to opioids who were starting antiretroviral therapy (ART) for HIV and whose viral loads were higher than 1000 copies per mL. Participants were seeking treatment at two HIV and two narcology programme centres in Saint Petersburg, Russia, and the surrounding Leningrad region', 'stratified participants according to gender, viral load, and CD4 cells per μL, and randomly assigned (1:1) them to addiction treatment with a', 'Between July 14, 2011, and April 14, 2014, 238 potential participants were recruited and screened, 35 were excluded for not meeting inclusion criteria, three declined to participate, and 200', 'people with HIV who are addicted to opioids']","['Slow-release naltrexone implant versus oral naltrexone', 'naltrexone implant and oral naltrexone placebo (implant group) or oral naltrexone and placebo implant (oral group', 'placebo']","['plasma viral load', 'overdose deaths', 'viral loads less', 'viral loads']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0242823', 'cui_str': 'Saints'}, {'cui': 'C0035970', 'cui_str': 'Russian Federation (Europe)'}, {'cui': 'C1282914', 'cui_str': 'Surrounding (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1.0,0.648254,"At week 24, 38 (38) participants in the implant group and 35 (35%) in the oral group had viral loads less than 400 copies per mL (risk ratio 1·1, 95% CI 0·76-1·56; p=0·77).","[{'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Krupitsky', 'Affiliation': 'First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia; VM Bekhterev National Medical Research Centre for Psychiatry and Neurology, Saint Petersburg, Russia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Blokhina', 'Affiliation': 'First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Zvartau', 'Affiliation': 'First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Verbitskaya', 'Affiliation': 'First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia.'}, {'ForeName': 'Dmitri', 'Initials': 'D', 'LastName': 'Lioznov', 'Affiliation': 'First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Yaroslavtseva', 'Affiliation': 'First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Palatkin', 'Affiliation': 'First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Vetrova', 'Affiliation': 'First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Bushara', 'Affiliation': 'First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Burakov', 'Affiliation': 'First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia.'}, {'ForeName': 'Dmitri', 'Initials': 'D', 'LastName': 'Masalov', 'Affiliation': 'First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Mamontova', 'Affiliation': 'First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Langleben', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Poole', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gross', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Woody', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: woodyg@pennmedicine.upenn.edu.'}]",The lancet. HIV,['10.1016/S2352-3018(18)30362-X']
562,32212518,A Phase 3 Trial of Luspatercept in Patients with Transfusion-Dependent β-Thalassemia.,"BACKGROUND


Patients with transfusion-dependent β-thalassemia need regular red-cell transfusions. Luspatercept, a recombinant fusion protein that binds to select transforming growth factor β superfamily ligands, may enhance erythroid maturation and reduce the transfusion burden (the total number of red-cell units transfused) in such patients.
METHODS


In this randomized, double-blind, phase 3 trial, we assigned, in a 2:1 ratio, adults with transfusion-dependent β-thalassemia to receive best supportive care plus luspatercept (at a dose of 1.00 to 1.25 mg per kilogram of body weight) or placebo for at least 48 weeks. The primary end point was the percentage of patients who had a reduction in the transfusion burden of at least 33% from baseline during weeks 13 through 24 plus a reduction of at least 2 red-cell units over this 12-week interval. Other efficacy end points included reductions in the transfusion burden during any 12-week interval and results of iron studies.
RESULTS


A total of 224 patients were assigned to the luspatercept group and 112 to the placebo group. Luspatercept or placebo was administered for a median of approximately 64 weeks in both groups. The percentage of patients who had a reduction in the transfusion burden of at least 33% from baseline during weeks 13 through 24 plus a reduction of at least 2 red-cell units over this 12-week interval was significantly greater in the luspatercept group than in the placebo group (21.4% vs. 4.5%, P<0.001). During any 12-week interval, the percentage of patients who had a reduction in transfusion burden of at least 33% was greater in the luspatercept group than in the placebo group (70.5% vs. 29.5%), as was the percentage of those who had a reduction of at least 50% (40.2% vs. 6.3%). The least-squares mean difference between the groups in serum ferritin levels at week 48 was -348 μg per liter (95% confidence interval, -517 to -179) in favor of luspatercept. Adverse events of transient bone pain, arthralgia, dizziness, hypertension, and hyperuricemia were more common with luspatercept than placebo.
CONCLUSIONS


The percentage of patients with transfusion-dependent β-thalassemia who had a reduction in transfusion burden was significantly greater in the luspatercept group than in the placebo group, and few adverse events led to the discontinuation of treatment. (Funded by Celgene and Acceleron Pharma; BELIEVE ClinicalTrials.gov number, NCT02604433; EudraCT number, 2015-003224-31.).",2020,"The percentage of patients with transfusion-dependent β-thalassemia who had a reduction in transfusion burden was significantly greater in the luspatercept group than in the placebo group, and few adverse events led to the discontinuation of treatment.","['Patients with Transfusion-Dependent β-Thalassemia', 'adults with transfusion-dependent β-thalassemia to receive best', '224 patients were assigned to the luspatercept group and 112 to the', 'Patients with transfusion-dependent β-thalassemia need regular red-cell transfusions']","['Luspatercept or placebo', 'supportive care plus luspatercept', 'placebo', 'Luspatercept']","['Adverse events of transient bone pain, arthralgia, dizziness, hypertension, and hyperuricemia', 'serum ferritin levels', 'transfusion burden']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0039730', 'cui_str': 'Thalassemia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4086553', 'cui_str': 'luspatercept'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}]","[{'cui': 'C4086553', 'cui_str': 'luspatercept'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0151825', 'cui_str': 'Bone pain (finding)'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}]",224.0,0.468436,"The percentage of patients with transfusion-dependent β-thalassemia who had a reduction in transfusion burden was significantly greater in the luspatercept group than in the placebo group, and few adverse events led to the discontinuation of treatment.","[{'ForeName': 'M Domenica', 'Initials': 'MD', 'LastName': 'Cappellini', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Vip', 'Initials': 'V', 'LastName': 'Viprakasit', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Ali T', 'Initials': 'AT', 'LastName': 'Taher', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Pencho', 'Initials': 'P', 'LastName': 'Georgiev', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Kevin H M', 'Initials': 'KHM', 'LastName': 'Kuo', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Coates', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Ersi', 'Initials': 'E', 'LastName': 'Voskaridou', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Hong-Keng', 'Initials': 'HK', 'LastName': 'Liew', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Idit', 'Initials': 'I', 'LastName': 'Pazgal-Kobrowski', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'G L', 'Initials': 'GL', 'LastName': 'Forni', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Silverio', 'Initials': 'S', 'LastName': 'Perrotta', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Abderrahim', 'Initials': 'A', 'LastName': 'Khelif', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Ashutosh', 'Initials': 'A', 'LastName': 'Lal', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Antonis', 'Initials': 'A', 'LastName': 'Kattamis', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Efthymia', 'Initials': 'E', 'LastName': 'Vlachaki', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Origa', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Yesim', 'Initials': 'Y', 'LastName': 'Aydinok', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Bejaoui', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'P Joy', 'Initials': 'PJ', 'LastName': 'Ho', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Lee-Ping', 'Initials': 'LP', 'LastName': 'Chew', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Ping-Chong', 'Initials': 'PC', 'LastName': 'Bee', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Soo-Min', 'Initials': 'SM', 'LastName': 'Lim', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Meng-Yao', 'Initials': 'MY', 'LastName': 'Lu', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Adisak', 'Initials': 'A', 'LastName': 'Tantiworawit', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Penka', 'Initials': 'P', 'LastName': 'Ganeva', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Liana', 'Initials': 'L', 'LastName': 'Gercheva', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Farrukh', 'Initials': 'F', 'LastName': 'Shah', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Ellis J', 'Initials': 'EJ', 'LastName': 'Neufeld', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Thompson', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Abderrahmane', 'Initials': 'A', 'LastName': 'Laadem', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Jeevan K', 'Initials': 'JK', 'LastName': 'Shetty', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Dimana', 'Initials': 'D', 'LastName': 'Miteva', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Zinger', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Linde', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Sherman', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Hermine', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Porter', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Piga', 'Affiliation': ""From the Department of Clinical Sciences and Community, University of Milan, IRCCS Ca' Granda Foundation Maggiore Policlinico Hospital, Milan (M.D.C.), Centro della Microcitemia e Anemie Congenite e del Dismetabolismo del Ferro, E.O. Ospedali Galliera, Genoa (G.L.F.), Ospedale Pediatrico Microcitemico A. Cao, Azienda Ospedaliera G. Brotzu, Cagliari (R.O.), Ematologia e Oncologia Pediatrica, Università della Campania L. Vanvitelli, Caserta (S.P.), and the Department of Clinical and Biological Sciences, University of Turin, Turin (A.P.) - all in Italy; Siriraj Hospital, Mahidol University, Bangkok (V.V.), and the Division of Hematology, Department of Internal Medicine, Chiang Mai University, Chiang Mai (A. Tantiworawit) - both in Thailand; the Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon (A.T.T.); St. George University Hospital for Active Treatment and Medical University of Plovdiv, Plovdiv (P. Georgiev), University Specialized Hospital for Active Treatment in Oncology, Sofia (P. Ganeva), and University Hospital St. Marina, Varna (L.G.) - all in Bulgaria; the Division of Medical Oncology and Hematology, Department of Medicine, University Health Network and Division of Hematology, Department of Medicine, University of Toronto, Toronto (K.H.M.K.); the Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, and Keck School of Medicine of the University of Southern California, Los Angeles (T.C.), and the University of California San Francisco Benioff Children's Hospital, Oakland (A. Lal) - all in California; the Thalassemia and Sickle Cell Center, Laiko General Hospital (E. Voskaridou), and the First Department of Pediatrics, National and Kapodistrian University of Athens (A. Kattamis), Athens, and the Adult Thalassemia Unit, Hippokration Hospital, Thessaloniki (E. Vlachaki) - all in Greece; Hospital Sultanah Bahiyah, Alor Setar (H.K.L.), Hospital Umum, Sarawak, Kuching (L.P.C.), the University of Malaya Medical Center, Kuala Lumpur (P.C.B.), and Hospital Sultanah Aminah, Johor Bahru (S.M.L.) - all in Malaysia; the Comprehensive Center of Thalassemia, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (I.P.-K.); Farhat Hached University Hospital, Sousse (A. Khelif), and the National Bone Marrow Transplant Center and Faculty of Medicine, University of Tunis El Manar, Tunis (M.B.) - both in Tunisia; the Department of Pediatric Hematology and Oncology, Ege University Hospital, Izmir, Turkey (Y.A.); Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.); National Taiwan University, Taipei, Taiwan (M.-Y. L.); the Department of Haematology, Whittington Health NHS Trust (F.S.), and the Department of Haematology, University College London and University College London Hospitals NHS Foundation Trust (J.P.) - all in London; St. Jude Children's Research Hospital, Memphis, TN (E.J.N.); Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (A. Thompson); Celgene, Summit, NJ (A. Laadem, J. Zou, J. Zhang); Celgene, Boudry, Switzerland (J.K.S., D.M., T.Z.); Acceleron Pharma, Cambridge, MA (P.G.L., M.L.S.); and the Department of Hematology, Necker Hospital, Assistance Publique-Hôpitaux de Paris (O.H.), and Imagine Institute, INSERM Unité 1163, University of Paris (O.H.) - both in Paris.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1910182']
563,32212888,A randomized controlled trial of real versus sham acupuncture for basal thumb joint arthritis.,"We report a single-blinded randomized controlled trial comparing acupuncture to sham (non-penetrating) needling for relief of symptoms of basal thumb joint arthritis. Seventy acupuncture naive patients with basal thumb joint arthritis were randomized to receive true acupuncture or sham needling with 35 patients in each arm. Blinded baseline and post-treatment assessments included visual analogue pain scores for different grips and movement. Function was assessed using the Nelson questionnaire. Both groups showed statistically and clinically significant improvements in pain at week one post-treatment compared with baseline, but there was no difference between the treatment groups. The pain relief was comparable with published data for some standard treatments. Acupuncture did not perform better than sham needling in this study, indicating that pain relief may have been achieved through non-specific mechanisms.  Level of evidence:  I.",2020,"Both groups showed statistically and clinically significant improvements in pain at week one post-treatment compared with baseline, but there was no difference between the treatment groups.","['basal thumb joint arthritis', 'Seventy acupuncture naive patients with basal thumb joint arthritis']","['true acupuncture or sham needling', 'Acupuncture', 'acupuncture to sham (non-penetrating) needling', 'sham acupuncture']","['pain', 'pain relief', 'visual analogue pain scores']","[{'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0040067', 'cui_str': 'Thumb'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205238', 'cui_str': 'True (qualifier value)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205321', 'cui_str': 'Penetrating (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",70.0,0.714385,"Both groups showed statistically and clinically significant improvements in pain at week one post-treatment compared with baseline, but there was no difference between the treatment groups.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Barnard', 'Affiliation': 'Pulvertaft Hand Centre, Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Jansen', 'Affiliation': 'Pulvertaft Hand Centre, Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Swindells', 'Affiliation': 'Pulvertaft Hand Centre, Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Arundell', 'Affiliation': 'Pulvertaft Hand Centre, Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'Frank D', 'Initials': 'FD', 'LastName': 'Burke', 'Affiliation': 'Pulvertaft Hand Centre, Royal Derby Hospital, Derby, UK.'}]","The Journal of hand surgery, European volume",['10.1177/1753193420911326']
564,27128107,"Comparative Safety, Efficiency, and Nursing Preference Among 3 Methods for Intravenous Push Medication Preparation: A Randomized Crossover Simulation Study.","OBJECTIVE


The aim of this study was to compare total time for drug preparation, associated errors, and nurses' preferences among 3 different intravenous (IV) push medication methods.
RESEARCH DESIGN


A randomized crossover simulation design was used to compare total time for drug preparation and incidence of medication preparation errors between BD Simplist (BDS), Carpuject (CJ), and traditional vial-and-syringe process (TVSP). Three medication preparation areas were created to mimic a hospital setting. Twenty-four critical care nurses were asked to prepare an IV dose of diphenhydramine, ketorolac, and morphine in random order using BDS, CJ, and TVSP, also in random order. Total time for the preparation of each drug was measured. Medication preparation errors were noted. At the start of the study, nurses were surveyed about their stress levels regarding aspects of IV push medications. At completion, nurses were asked to rank order from the most to the least preferred administration method.
RESULTS


Mean time in seconds for drug preparation was significantly shorter (P < 0.004) with BDS (28.7; 95% confidence interval [CI], 23.3-34.2) and CJ (28.3; 95% CI, 23.1-33.5) compared with TSVP (65.8; 95% CI, 57.7-73.9). The time difference between BDS and CJ was not statistically significant. Medication preparation errors were significantly reduced with BDS compared with both CJ and TVSP (1.4% versus 77.8% versus 73.6%; P < 0.001). The BDS was ranked by nurses as the most preferred method.
CONCLUSIONS


The BD Simplist system for IV push medications may offer nurses an opportunity to reduce steps and reduce errors during medication preparation.",2019,"Mean time in seconds for drug preparation was significantly shorter (P < 0.004) with BDS (28.7; 95% confidence interval [CI], 23.3-34.2) and CJ (28.3; 95% CI, 23.1-33.5) compared with TSVP (65.8; 95% CI, 57.7-73.9).",['Twenty-four critical care nurses'],"['Intravenous Push Medication Preparation', 'diphenhydramine, ketorolac, and morphine', 'BD Simplist (BDS), Carpuject (CJ), and traditional vial-and-syringe process (TVSP', 'CJ and TVSP']","['Medication preparation errors', 'total time for drug preparation and incidence of medication preparation errors', 'Comparative Safety, Efficiency, and Nursing Preference', 'BDS', 'Mean time', 'Total time']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0010337', 'cui_str': 'Critical Care'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1719958', 'cui_str': 'Push'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C1706398', 'cui_str': 'Vil'}, {'cui': 'C0184957', 'cui_str': 'Irrigation with syringe (procedure)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0013164', 'cui_str': 'Drug Preparation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0539797,"Mean time in seconds for drug preparation was significantly shorter (P < 0.004) with BDS (28.7; 95% confidence interval [CI], 23.3-34.2) and CJ (28.3; 95% CI, 23.1-33.5) compared with TSVP (65.8; 95% CI, 57.7-73.9).","[{'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Burger', 'Affiliation': 'From the Visante Inc, St. Paul, Minnesota.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Degnan', 'Affiliation': 'Center for Medication Safety Advancement, Purdue University College of Pharmacy, Fishers, Indiana.'}]",Journal of patient safety,['10.1097/PTS.0000000000000269']
565,32227179,Effect of Default Options in Advance Directives on Hospital-Free Days and Care Choices Among Seriously Ill Patients: A Randomized Clinical Trial.,"Importance


There is limited evidence regarding how patients make choices in advance directives (ADs) or whether these choices influence subsequent care.
Objective


To examine whether default options in ADs influence care choices and clinical outcomes.
Design, Setting, and Participants


This randomized clinical trial included 515 patients who met criteria for having serious illness and agreed to participate. Patients were enrolled at 20 outpatient clinics affiliated with the University of Pennsylvania Health System and the University of Pittsburgh Medical Center from February 2014 to April 2016 and had a median follow-up of 18 months. Data analysis was conducted from November 2018 to April 2019.
Interventions


Patients were randomly assigned to complete 1 of the 3 following ADs: (1) a comfort-promoting plan of care and nonreceipt of potentially life-sustaining therapies were selected by default (comfort AD), (2) a life-extending plan of care and receipt of potentially life-sustaining therapies were selected by default (life-extending AD), or (3) no choices were preselected (standard AD).
Main Outcomes and Measures


This trial was powered to rule out a reduction in hospital-free days in the intervention groups. Secondary outcomes included choices in ADs for an overall comfort-oriented approach to care, choices to forgo 4 forms of life support, patients' quality of life, decision conflict, place of death, admissions to hospitals and intensive care units, and costs of inpatient care.
Results


Among 515 patients randomized, 10 withdrew consent and 13 were later found to be ineligible, leaving 492 (95.5%) in the modified intention-to-treat (mITT) sample (median [interquartile range] age, 63 [56-70] years; 279 [56.7%] men; 122 [24.8%] black; 363 [73.8%] with cancer). Of these, 264 (53.7%) returned legally valid ADs and were debriefed about their assigned intervention. Among these, patients completing comfort ADs were more likely to choose comfort care (54 of 85 [63.5%]) than those returning standard ADs (45 of 91 [49.5%]) or life-extending ADs (33 of 88 [37.5%]) (P = .001). Among 492 patients in the mITT sample, 57 of 168 patients [33.9%] who completed the comfort AD, 47 of 165 patients [28.5%] who completed the standard AD, and 35 of 159 patients [22.0%] who completed the life-extending AD chose comfort care (P = .02), with patients not returning ADs coded as not selecting comfort care. In mITT analyses, median (interquartile range) hospital-free days among 168 patients assigned to comfort ADs and 159 patients assigned to life-extending default ADs were each noninferior to those among 165 patients assigned to standard ADs (standard AD: 486 [306-717] days; comfort AD: 554 [296-833] days; rate ratio, 1.05; 95% CI, 0.90-1.23; P < .001; life-extending AD: 550 [325-783] days; rate ratio, 1.03; 95% CI, 0.88-1.20; P < .001). There were no differences among groups in other secondary outcomes.
Conclusions and Relevance


In this randomized clinical trial, default options in ADs altered the choices seriously ill patients made regarding their future care without changing clinical outcomes.
Trial Registration


ClinicalTrials.gov Identifier: NCT02017548.",2020,"There were no differences among groups in other secondary outcomes.
","['Patients were enrolled at 20 outpatient clinics affiliated with the University of Pennsylvania Health System and the University of Pittsburgh Medical Center from February 2014 to April 2016 and had a median follow-up of 18 months', 'November 2018 to April 2019', '515 patients who met criteria for having serious illness and agreed to participate', '515 patients randomized, 10 withdrew consent and 13 were later found to be ineligible, leaving 492 (95.5%) in the modified intention-to-treat (mITT) sample (median [interquartile range] age, 63 [56-70] years; 279 [56.7%] men; 122 [24.8%] black; 363 [73.8%] with cancer', 'Seriously Ill Patients', '492 patients in the mITT sample, 57 of 168 patients [33.9%] who completed the comfort AD, 47 of 165 patients [28.5%] who completed the standard AD, and 35 of 159 patients [22.0%] who completed the']","['comfort-promoting plan of care and nonreceipt of potentially life-sustaining therapies were selected by default (comfort AD), (2) a life-extending plan of care and receipt of potentially life-sustaining therapies were selected by default (life-extending AD), or (3) no choices were preselected (standard AD']","['comfort care', 'life-extending AD chose comfort care', ""choices in ADs for an overall comfort-oriented approach to care, choices to forgo 4 forms of life support, patients' quality of life, decision conflict, place of death, admissions to hospitals and intensive care units, and costs of inpatient care"", 'Hospital-Free Days and Care Choices', 'legally valid ADs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C4517718', 'cui_str': '33.9'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0150521', 'cui_str': 'Comfort Care'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0421611', 'cui_str': 'Place of death (observable entity)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",515.0,0.193088,"There were no differences among groups in other secondary outcomes.
","[{'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Halpern', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Dylan S', 'Initials': 'DS', 'LastName': 'Small', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Troxel', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cooney', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Bayes', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Marzana', 'Initials': 'M', 'LastName': 'Chowdhury', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Heather E', 'Initials': 'HE', 'LastName': 'Tomko', 'Affiliation': 'Department of Health Policy and Management, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Arnold', 'Affiliation': 'Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Loewenstein', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'White', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Bryce', 'Affiliation': 'Department of Health Policy and Management, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.1742']
566,32224119,Effectiveness of manual and electrical needle stimulation in acupuncture for chronic nonspecific low back pain: a randomized controlled trial.,"AIM


The aim of this study was to investigate effectiveness of electroacupuncture (EA) and manual acupuncture (MA) on pain and disability in patients with chronic low back.
METHODS


A total of 66 randomly allocated patients diagnosed with chronic LBP were assigned to receive either 12 sessions of acupuncture or electroacupuncture. The primary outcomes measurements were intensity pain (NRS) and disability (RMQ). All main analysis followed the intention-to-treat principle.
RESULTS


The groups reported improvements posttreatment in intensity pain and disability respectively; however, no differences between groups were observed. Regarding the secondary outcomes, we observed a between-group difference only for kinesiophobia in favor of the manual acupuncture group (difference = -4.1 points, 95% CI = -7.0 to -1.1). The results were maintained after 3 months of follow-up. Contrary to our hypothesis, however, EA did not result in a better outcome compared with MA treatment.
CONCLUSION


The study does not provide evidence that an electroacupuncture is superior to acupuncture treatment. Both therapies had similar efficacy in reducing pain and disability for chronic nonspecific low back pain.",2020,"Regarding the secondary outcomes, we observed a between-group difference only for kinesiophobia in favor of the manual acupuncture group (difference = -4.1 points, 95% CI = -7.0 to -1.1).","['chronic nonspecific low back pain', 'patients with chronic low back', '66 randomly allocated patients diagnosed with chronic LBP']","['manual and electrical needle stimulation', 'electroacupuncture (EA) and manual acupuncture (MA', 'acupuncture or electr LINK Word', 'acupuncture', 'electroacupuncture']","['intensity pain and disability', 'intensity pain (NRS) and disability (RMQ', 'pain and disability', 'kinesiophobia']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939142', 'cui_str': 'Lower back (surface region)'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}]",66.0,0.286124,"Regarding the secondary outcomes, we observed a between-group difference only for kinesiophobia in favor of the manual acupuncture group (difference = -4.1 points, 95% CI = -7.0 to -1.1).","[{'ForeName': 'Josielli', 'Initials': 'J', 'LastName': 'Comachio', 'Affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil. Electronic address: josiecomachio@gmail.com.'}, {'ForeName': 'Carla Coelho', 'Initials': 'CC', 'LastName': 'Oliveira', 'Affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Ilton Fagner', 'Initials': 'IF', 'LastName': 'Rodrigues Silva', 'Affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Mauricio Oliveira', 'Initials': 'MO', 'LastName': 'Magalhães', 'Affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, University of Para, Belem, Brazil; Physical Therapy, Speech and Occupational Therapy Department, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Amélia Pasqual', 'Initials': 'AP', 'LastName': 'Marques', 'Affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}]",Journal of acupuncture and meridian studies,['10.1016/j.jams.2020.03.064']
567,30772370,How should sugar-sweetened beverage health warnings be designed? A randomized experiment.,"Health warnings are a promising strategy for reducing consumption of sugar-sweetened beverages (SSBs), but uncertainty remains about how to design warnings to maximize their impact. Warnings already implemented in Latin America use nutrient disclosures, while proposed U.S. warnings would describe the health effects of consuming SSBs. We sought to determine whether warning characteristics influence consumers' reactions to SSB health warnings. A national convenience sample of U.S. adults (n = 1360) completed an online survey in 2018. In a factorial design, we randomly assigned participants to view SSB health warnings that differed in: 1) inclusion of health effects (""Drinking beverages with added sugar contributes to obesity, diabetes, and tooth decay""); 2) inclusion of a nutrient disclosure (""High in added sugar""); 3) inclusion of the marker word ""WARNING;"" and 4) shape (octagon vs. rectangle). The primary outcome was perceived message effectiveness (PME, range 1-5). PME was higher for warnings that included health effects (average differential effect [ADE] = 0.63, p < 0.001) or nutrient disclosures (ADE = 0.32, p < 0.001) compared to warnings without this information. However, adding a nutrient disclosure to a warning that already included health effects did not lead to higher PME compared to warnings with health effects alone. The marker ""WARNING"" (ADE = 0.21) and the octagon shape (ADE = 0.08) also led to higher PME compared to warnings without these characteristics (ps < 0.001). The same pattern of results held for the secondary outcomes, fear and thinking about harms. SSB health warnings may have more impact if they describe health effects, use the marker ""WARNING,"" and are octagon-shaped.",2019,"PME was higher for warnings that included health effects (average differential effect [ADE] = 0.63, p < 0.001) or nutrient disclosures (ADE = 0.32, p < 0.001) compared to warnings without this information.",['A national convenience sample of U.S. adults (n\u202f=\u202f1360) completed an online survey in 2018'],"['health effects (""Drinking beverages with added sugar contributes to obesity, diabetes, and tooth decay""); 2) inclusion of a nutrient disclosure (""High in added sugar""); 3) inclusion of the marker word ""WARNING;"" and 4) shape (octagon vs. rectangle']","['PME', 'message effectiveness (PME, range 1-5', 'fear and thinking about harms']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011334', 'cui_str': 'Dental Decay'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0205142', 'cui_str': 'Rectangular (qualifier value)'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C4319827', 'cui_str': 'Thought'}]",,0.107256,"PME was higher for warnings that included health effects (average differential effect [ADE] = 0.63, p < 0.001) or nutrient disclosures (ADE = 0.32, p < 0.001) compared to warnings without this information.","[{'ForeName': 'Anna H', 'Initials': 'AH', 'LastName': 'Grummon', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina Chapel Hill, Chapel Hill, NC, United States of America; Carolina Population Center, University of North Carolina Chapel Hill, Chapel Hill, NC, United States of America. Electronic address: agrummon@unc.edu.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina Chapel Hill, Chapel Hill, NC, United States of America; Lineberger Comprehensive Cancer Center, University of North Carolina Chapel Hill, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Lindsey Smith', 'Initials': 'LS', 'LastName': 'Taillie', 'Affiliation': 'Carolina Population Center, University of North Carolina Chapel Hill, Chapel Hill, NC, United States of America; Department of Nutrition, Gillings School of Global Public Health, University of North Carolina Chapel Hill, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Brewer', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina Chapel Hill, Chapel Hill, NC, United States of America; Lineberger Comprehensive Cancer Center, University of North Carolina Chapel Hill, Chapel Hill, NC, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2019.02.010']
568,32227625,Personalized application of three different concentrations of iodinated contrast media in coronary computed tomography angiography.,"No study has evaluated the impact of different iodinated contrast media on coronary contrast enhancement, using an injection protocol according to body surface area (BSA). Thus, the present study aimed to examine the usefulness and safety of personalized application of different iodine concentrations of contrast media in coronary computed tomographic (CT) angiography with a 2nd dual-source CT scanner in eliminating differences in coronary contrast enhancement based on a BSA-adapted injection protocol of contrast media. A total of 270 enrolled participants were randomly assigned to three groups: ioversol 320, ioversol 350 and iopromide 370 (n = 90 per group). The three groups were administered contrast media at a BSA-adjusted volume and flow rate with a fixed injection time of 15 seconds, and they subsequently received a 30-mL saline flush. All patients were scanned with a prospective electrocardiogram-gated protocol in a craniocaudal direction using a second-generation 128-slice dual-source CT system. The three iodinated contrast media used in coronary CT angiography exhibited similar diagnostic quality and safety. No significant differences were found in the contrast enhancement degrees, image quality scores, radiation doses and incidences of adverse effects among the three groups. The three contrast media used in coronary CT angiography with 320, 350 and 370 mg/mL iodine, respectively, have comparable diagnostic quality and safety. However, more large-scale, multinational, multi-centre and prospective trials are warranted.",2020,"No significant differences were found in the contrast enhancement degrees, image quality scores, radiation doses and incidences of adverse effects among the three groups.",['A total of 270 enrolled participants'],"['contrast media in coronary computed tomographic (CT) angiography with a 2nd dual-source CT scanner', 'electrocardiogram-gated protocol in a craniocaudal direction using a second-generation 128-slice dual-source CT system', 'ioversol 320, ioversol 350 and iopromide', '30-mL saline flush', 'iodinated contrast media in coronary computed tomography angiography', 'coronary CT angiography']","['diagnostic quality and safety', 'contrast enhancement degrees, image quality scores, radiation doses and incidences of adverse effects']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast Agents'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205436', 'cui_str': 'Second - ordinal'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0063828', 'cui_str': 'ioversol'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0063817', 'cui_str': 'iopromide'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C1960405', 'cui_str': 'Iodinated contrast media'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C1536105', 'cui_str': 'Angiography, CT'}]","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",270.0,0.0175523,"No significant differences were found in the contrast enhancement degrees, image quality scores, radiation doses and incidences of adverse effects among the three groups.","[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'The Key Laboratory of Cardiovascular Remodeling and Function Research, Chinese Ministry of Education, Chinese National Health Commission and Chinese Academy of Medical Sciences, The State and Shandong Province Joint Key Laboratory of Translational Cardiovascular Medicine, Department of Cardiology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'Hao', 'Affiliation': 'The Key Laboratory of Cardiovascular Remodeling and Function Research, Chinese Ministry of Education, Chinese National Health Commission and Chinese Academy of Medical Sciences, The State and Shandong Province Joint Key Laboratory of Translational Cardiovascular Medicine, Department of Cardiology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Chenyu', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Shandong Institute of Innovation, Suzhou Institute of Biomedical Engineering and Technology Affiliated with Chinese Academy of Sciences, Jinan, China.'}, {'ForeName': 'Guoxiang', 'Initials': 'G', 'LastName': 'Hao', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmaceutical Sciences of Shandong University, Jinan, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Jinan Central Hospital Affiliated with Shandong First Medical University and Shandong University, Jinan, China.'}, {'ForeName': 'Peixin', 'Initials': 'P', 'LastName': 'Hu', 'Affiliation': 'Jinan Central Hospital Affiliated with Shandong First Medical University and Shandong University, Jinan, China.'}, {'ForeName': 'Qingjie', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'First Hospital Affiliated with Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Yuguo', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'The Key Laboratory of Cardiovascular Remodeling and Function Research, Chinese Ministry of Education, Chinese National Health Commission and Chinese Academy of Medical Sciences, The State and Shandong Province Joint Key Laboratory of Translational Cardiovascular Medicine, Department of Cardiology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Aifeng', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': ""Department of Nephrology, Brigham and Women's Hospital Affiliated with Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'The Key Laboratory of Cardiovascular Remodeling and Function Research, Chinese Ministry of Education, Chinese National Health Commission and Chinese Academy of Medical Sciences, The State and Shandong Province Joint Key Laboratory of Translational Cardiovascular Medicine, Department of Cardiology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Qilu Hospital of Shandong University, Jinan, China.'}]",Journal of cellular and molecular medicine,['10.1111/jcmm.15196']
569,32233252,"[Effect of  Buyang Huanwu  decoction (, BYHWD) on X-ray evaluation of early callus and level of serum alkaline phosphatase in elderly patients with Colles fracture after manual reduction and splint external fixation].","OBJECTIVE


To explore effects of  Buyang Huanwu  Decoction (, BYHWD) on early callus X-ray evaluation and level of serum alkaline phosphatase in elderly patients with Colles fracture after manual reduction and splint external fixation.
METHODS


From October 2016 to October 2018, 60 elderly patients with Colles fractures were treated with manual reduction and splint external fixation and were divided into experimental group and control group. There were 30 patients in control group, including 15 males and 15 females; aged from 56 to 75 years old with an average of (67.81±5.41) years old; bone mineral density was (0.82±0.24) g/cm 2; patients were performed lift shoulders, bend and extend elbow joint, stretch five fingers and make a fist at 3 days after operation, 3 times daily for 1 month, 30 min once a time. There were 30 patients in experimental group, including 13 males and 17 females; aged from 57 to 77 years old with an average of (66.02±5.16) years old; bone mineral density was (0.76±0.23) g/cm 2 ; patients performed rehabilitation exercise as control group and combined with BYHWD, 400 ml per dose, 2 times daily, 7 days as one course, totally 4 courses. RUSS scores at 14 and 28 days after reduction between two groups were compared, serum level of alkaline phosphatase (ALP) and serum calcium concentration were observed at immediately, 14 and 28 days after reduction.
RESULTS


The patients between two groups were successfully fixed without re fractures and complications occurred. The patients were followed up for 30 to 35 days with an average of (31.60±1.03) days. RUSS score in experimental group at 14 and 28 days after reduction were 4.58±0.31 and 7.07±0.36, respectively; while in control group were 3.98±0.30 and 6.15±0.35, respectively; RUSS score in experimental group was significantly higher than that of control group. Serum alkaline phosphatase concentrations in experimental group at immediately, 14 and 28 days after reduction were (90.62±12.19) mmol/L ,(105.40±11.63) mmol/L, and (160.86±35.77) mmol/L respectively; while in controlgroup were (91.27±13.52) mmol/L ,(94.60±11.10) mmol/L ,(144.17±26.27) mmol/L respectively; there was no statistically difference between two groups at immediately; and had statistically differences between two groups at 14 and 28 days after reduction. There was no significant difference in serum calcium concentration between two groups at immediately, 14 and 28 days after reduction.
CONCLUSION


BYHWD for elderly patients with Colles fracture could promote early formation of callus, effectively increase concentration of serum alkaline phosphatase and promote fracture healing.",2020,"Serum alkaline phosphatase concentrations in experimental group at immediately, 14 and 28 days after reduction were (90.62±12.19) mmol/L ,(105.40±11.63) mmol/L, and (160.86±35.77) mmol/L respectively; while in controlgroup were (91.27±13.52) mmol/L ,(94.60±11.10) mmol/L ,(144.17±26.27) mmol/L respectively; there was no statistically difference between two groups at immediately; and had statistically differences between two groups at 14 and 28 days after reduction.","['30 patients in experimental group, including 13 males and 17 females; aged from 57 to 77 years old with an average of (66.02±5.16) years old; bone mineral density was (0.76±0.23) g/cm 2 ; patients performed', 'elderly patients with Colles fracture after manual reduction and splint external fixation', '30 patients in control group, including 15 males and 15 females; aged from 56 to 75 years old with an average of (67.81±5.41) years old; bone mineral density was (0.82±0.24', 'elderly patients with Colles fracture', 'From October 2016 to October 2018, 60 elderly patients with Colles fractures']","['manual reduction and splint external fixation', 'Buyang Huanwu  decoction (, BYHWD', 'rehabilitation exercise', 'Buyang Huanwu  Decoction (, BYHWD']","['serum calcium concentration', 'RUSS score', 'RUSS scores', 'serum level of alkaline phosphatase (ALP) and serum calcium concentration', 'Serum alkaline phosphatase concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0009353', 'cui_str': ""Colles' Fracture""}, {'cui': 'C0185114', 'cui_str': 'Manual reduction - action'}, {'cui': 'C0204861', 'cui_str': 'Application of splint (procedure)'}, {'cui': 'C0407333', 'cui_str': 'Fixation of fracture using external fixator (procedure)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0185114', 'cui_str': 'Manual reduction - action'}, {'cui': 'C0204861', 'cui_str': 'Application of splint (procedure)'}, {'cui': 'C0407333', 'cui_str': 'Fixation of fracture using external fixator (procedure)'}, {'cui': 'C1137699', 'cui_str': 'buyang huanwu decoction'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}]","[{'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0036776', 'cui_str': 'Serum alkaline phosphatase measurement'}]",60.0,0.016968,"Serum alkaline phosphatase concentrations in experimental group at immediately, 14 and 28 days after reduction were (90.62±12.19) mmol/L ,(105.40±11.63) mmol/L, and (160.86±35.77) mmol/L respectively; while in controlgroup were (91.27±13.52) mmol/L ,(94.60±11.10) mmol/L ,(144.17±26.27) mmol/L respectively; there was no statistically difference between two groups at immediately; and had statistically differences between two groups at 14 and 28 days after reduction.","[{'ForeName': 'Xing-Tong', 'Initials': 'XT', 'LastName': 'Xiang', 'Affiliation': 'The Second Affiliated Hospital of Hunan University of Chinese Medicine, Changsha 410208, Hunan, China.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Dou', 'Affiliation': 'The Second Affiliated Hospital of Hunan University of Chinese Medicine, Changsha 410208, Hunan, China.'}, {'ForeName': 'Shi-Feng', 'Initials': 'SF', 'LastName': 'Han', 'Affiliation': 'The Second Affiliated Hospital of Hunan University of Chinese Medicine, Changsha 410208, Hunan, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Kong', 'Affiliation': 'The Second Affiliated Hospital of Hunan University of Chinese Medicine, Changsha 410208, Hunan, China.'}, {'ForeName': 'Xiao-Lan', 'Initials': 'XL', 'LastName': 'Liu', 'Affiliation': 'The Second Affiliated Hospital of Hunan University of Chinese Medicine, Changsha 410208, Hunan, China.'}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2020.03.011']
570,32065623,"Clinical Effects of the Self-administered Subcutaneous Complement Inhibitor Zilucoplan in Patients With Moderate to Severe Generalized Myasthenia Gravis: Results of a Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial.","Importance


Many patients with generalized myasthenia gravis (gMG) have substantial clinical disability, persistent disease burden, and adverse effects attributable to chronic immunosuppression. Therefore, there is a significant need for targeted, well-tolerated therapies with the potential to improve disease control and enhance quality of life.
Objective


To evaluate the clinical effects of zilucoplan, a subcutaneously (SC) self-administered macrocyclic peptide inhibitor of complement component 5, in a broad population of patients with moderate to severe gMG.
Design, Setting, and Participants


This randomized, double-blind, placebo-controlled phase 2 clinical trial at 25 study sites across North America recruited participants between December 2017 and August 2018. Fifty-seven patients were screened, of whom 12 did not meet inclusion criteria and 1 was lost to follow-up after randomization but before receiving study drug, resulting in a total of 44 acetylcholine receptor autoantibody (AChR-Ab)-positive patients with gMG with baseline Quantitative Myasthenia Gravis (QMG) scores of at least 12, regardless of treatment history.
Interventions


Patients were randomized 1:1:1 to a daily SC self-injection of placebo, 0.1-mg/kg zilucoplan, or 0.3-mg/kg zilucoplan for 12 weeks.
Main Outcomes and Measures


The primary and key secondary end points were the change from baseline to week 12 in QMG and MG Activities of Daily Living scores, respectively. Significance testing was prespecified at a 1-sided α of .10. Safety and tolerability were also assessed.
Results


The study of 44 patients was well balanced across the 3 treatment arms with respect to key demographic and disease-specific variables. The mean age of patients across all 3 treatment groups ranged from 45.5 to 54.6 years and most patients were white (average proportions across 3 treatment groups: 78.6%-86.7%). Clinically meaningful and statistically significant improvements in primary and key secondary efficacy end points were observed. Zilucoplan at a dose of 0.3 mg/kg SC daily resulted in a mean reduction from baseline of 6.0 points in the QMG score (placebo-corrected change, -2.8; P = .05) and 3.4 points in the MG Activities of Daily Living score (placebo-corrected change, -2.3; P = .04). Clinically meaningful and statistically significant improvements were also observed in other secondary end points, the MG Composite and MG Quality-of-Life scores. Outcomes for the 0.1-mg/kg SC daily dose were also statistically significant but slower in onset and less pronounced than with the 0.3-mg/kg dose. Rescue therapy (intravenous immunoglobulin or plasma exchange) was required in 3 of 15, 1 of 15, and 0 of 14 participants in the placebo, 0.1-mg/kg zilucoplan, and 0.3-mg/kg zilucoplan arms, respectively. Zilucoplan was observed to have a favorable safety and tolerability profile.
Conclusions and Relevance


Zilucoplan yielded rapid, meaningful, and sustained improvements over 12 weeks in a broad population of patients with moderate to severe AChR-Ab-positive gMG. Near-complete complement inhibition appeared superior to submaximal inhibition. The observed safety and tolerability profile of zilucoplan was favorable.
Trial Registration


ClinicalTrials.gov Identifier: NCT03315130.",2020,"Clinically meaningful and statistically significant improvements were also observed in other secondary end points, the MG Composite and MG Quality-of-Life scores.","['44 patients was well balanced across the 3 treatment arms with respect to key demographic and disease-specific variables', 'Patients With Moderate to Severe Generalized Myasthenia Gravis', 'patients with generalized myasthenia gravis (gMG', '25 study sites across North America recruited participants between December 2017 and August 2018', 'Fifty-seven patients were screened, of whom 12 did not meet inclusion criteria and 1 was lost to follow-up after randomization but before receiving study drug, resulting in a total of 44 acetylcholine receptor autoantibody (AChR-Ab)-positive patients with gMG with baseline Quantitative Myasthenia Gravis (QMG) scores of at least 12, regardless of treatment history', 'patients with moderate to severe gMG']","['zilucoplan', 'placebo', 'zilucoplan, a subcutaneously (SC) self-administered macrocyclic peptide inhibitor', 'Self-administered Subcutaneous Complement Inhibitor Zilucoplan', 'daily SC self-injection of placebo, 0.1-mg/kg zilucoplan, or 0.3-mg/kg zilucoplan', 'Rescue therapy (intravenous immunoglobulin or plasma exchange', 'placebo, 0.1-mg/kg zilucoplan, and 0.3-mg/kg zilucoplan', 'Zilucoplan', 'Placebo']","['QMG and MG Activities of Daily Living scores', 'favorable safety and tolerability profile', 'MG Composite and MG Quality-of-Life scores', 'Daily Living score', 'QMG score', 'Safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0751339', 'cui_str': 'Myasthenia Gravis, Generalized'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia Gravis'}, {'cui': 'C0765796', 'cui_str': 'GMG'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0034792', 'cui_str': 'Receptors, Acetylcholine'}, {'cui': 'C0004358', 'cui_str': 'Autoantibodies'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1564892', 'cui_str': 'Complement Inactivating Agents'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C0032113', 'cui_str': 'Plasma Exchange'}]","[{'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",57.0,0.514858,"Clinically meaningful and statistically significant improvements were also observed in other secondary end points, the MG Composite and MG Quality-of-Life scores.","[{'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Howard', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Nowak', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Gil I', 'Initials': 'GI', 'LastName': 'Wolfe', 'Affiliation': 'University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Miriam L', 'Initials': 'ML', 'LastName': 'Freimer', 'Affiliation': 'Ohio State University, Columbus.'}, {'ForeName': 'Tuan H', 'Initials': 'TH', 'LastName': 'Vu', 'Affiliation': 'University of South Florida, Tampa.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Hinton', 'Affiliation': 'Infirmary Health, Mobile, Alabama.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Benatar', 'Affiliation': 'University of Miami, Miami, Florida.'}, {'ForeName': 'Petra W', 'Initials': 'PW', 'LastName': 'Duda', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'MacDougall', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Farzaneh-Far', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Kaminski', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Barohn', 'Affiliation': 'University of Kansas, Fairway.'}, {'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Dimachkie', 'Affiliation': 'University of Kansas, Fairway.'}, {'ForeName': 'Mamatha', 'Initials': 'M', 'LastName': 'Pasnoor', 'Affiliation': 'University of Kansas, Fairway.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Farmakidis', 'Affiliation': 'University of Kansas, Fairway.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'University of Kansas, Fairway.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Colgan', 'Affiliation': 'University of Kansas, Fairway.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Benatar', 'Affiliation': 'University of Miami, Miami, Florida.'}, {'ForeName': 'Tulio', 'Initials': 'T', 'LastName': 'Bertorini', 'Affiliation': 'Wesley Neurology Clinic, Cordova, Tennessee.'}, {'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Pillai', 'Affiliation': 'Wesley Neurology Clinic, Cordova, Tennessee.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Henegar', 'Affiliation': 'Wesley Neurology Clinic, Cordova, Tennessee.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bromberg', 'Affiliation': 'University of Utah, Salt Lake City.'}, {'ForeName': 'Summer', 'Initials': 'S', 'LastName': 'Gibson', 'Affiliation': 'University of Utah, Salt Lake City.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Janecki', 'Affiliation': 'University of Utah, Salt Lake City.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Freimer', 'Affiliation': 'Ohio State University, Columbus.'}, {'ForeName': 'Bakri', 'Initials': 'B', 'LastName': 'Elsheikh', 'Affiliation': 'Ohio State University, Columbus.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Matisak', 'Affiliation': 'Ohio State University, Columbus.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Genge', 'Affiliation': 'Montreal Neurological Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Guidon', 'Affiliation': 'Massachusetts General Hospital, Boston.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'David', 'Affiliation': 'Massachusetts General Hospital, Boston.'}, {'ForeName': 'Ali A', 'Initials': 'AA', 'LastName': 'Habib', 'Affiliation': 'University of California, Irvine, Orange.'}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Mathew', 'Affiliation': 'University of California, Irvine, Orange.'}, {'ForeName': 'Tahseen', 'Initials': 'T', 'LastName': 'Mozaffar', 'Affiliation': 'University of California, Irvine, Orange.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Hinton', 'Affiliation': 'Infirmary Health, Mobile, Alabama.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hewitt', 'Affiliation': 'Infirmary Health, Mobile, Alabama.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Barnett', 'Affiliation': 'Infirmary Health, Mobile, Alabama.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sullivan', 'Affiliation': 'Infirmary Health, Mobile, Alabama.'}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'Ho', 'Affiliation': 'Lahey Hospital, Burlington, Massachusetts.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Howard', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Traub', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Chopra', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Kaminski', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': 'Radwa', 'Initials': 'R', 'LastName': 'Aly', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Bayat', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Abu-Rub', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': 'Shaida', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'University of Texas Southwestern, Dallas, Irving.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Lange', 'Affiliation': 'Hospital for Special Surgery, New York, New York.'}, {'ForeName': 'Shara', 'Initials': 'S', 'LastName': 'Holzberg', 'Affiliation': 'Hospital for Special Surgery, New York, New York.'}, {'ForeName': 'Bhupendra', 'Initials': 'B', 'LastName': 'Khatri', 'Affiliation': 'Center for Neurological Disorders, St Francis Hospital at Ascension, Milwaukee, Wisconsin.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Lindman', 'Affiliation': 'Center for Neurological Disorders, St Francis Hospital at Ascension, Milwaukee, Wisconsin.'}, {'ForeName': 'Tayo', 'Initials': 'T', 'LastName': 'Olapo', 'Affiliation': 'Center for Neurological Disorders, St Francis Hospital at Ascension, Milwaukee, Wisconsin.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Sershon', 'Affiliation': 'Center for Neurological Disorders, St Francis Hospital at Ascension, Milwaukee, Wisconsin.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Lisak', 'Affiliation': 'Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Evanthia', 'Initials': 'E', 'LastName': 'Bernitsas', 'Affiliation': 'Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Jia', 'Affiliation': 'Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Malik', 'Affiliation': 'Rush University, Chicago, Illinois.'}, {'ForeName': 'Tiffany D', 'Initials': 'TD', 'LastName': 'Lewis-Collins', 'Affiliation': 'Rush University, Chicago, Illinois.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nicolle', 'Affiliation': 'London Health Sciences Center, London, Ontario, Canada.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Nowak', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Bhaskar', 'Initials': 'B', 'LastName': 'Roy', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Nye', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pulley', 'Affiliation': 'University of Florida, Jacksonville.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Berger', 'Affiliation': 'University of Florida, Jacksonville.'}, {'ForeName': 'Yasmeen', 'Initials': 'Y', 'LastName': 'Shabbir', 'Affiliation': 'University of Florida, Jacksonville.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Sachdev', 'Affiliation': 'Michigan State University, East Lansing.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Patterson', 'Affiliation': 'Michigan State University, East Lansing.'}, {'ForeName': 'Zaeem', 'Initials': 'Z', 'LastName': 'Siddiqi', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sivak', 'Affiliation': 'Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Bratton', 'Affiliation': 'Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Small', 'Affiliation': 'Allegheny Neurological Associates, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Anem', 'Initials': 'A', 'LastName': 'Kohli', 'Affiliation': 'Allegheny Neurological Associates, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fetter', 'Affiliation': 'Allegheny Neurological Associates, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Tuan', 'Initials': 'T', 'LastName': 'Vu', 'Affiliation': 'University of South Florida, Tampa.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Lam', 'Affiliation': 'University of South Florida, Tampa.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Harvey', 'Affiliation': 'University of South Florida, Tampa.'}, {'ForeName': 'Gil I', 'Initials': 'GI', 'LastName': 'Wolfe', 'Affiliation': 'University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Silvestri', 'Affiliation': 'University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Patrick', 'Affiliation': 'University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Zakalik', 'Affiliation': 'University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Petra W', 'Initials': 'PW', 'LastName': 'Duda', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'MacDougall', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Farzaneh-Far', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Pontius', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hoarty', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}]",JAMA neurology,['10.1001/jamaneurol.2019.5125']
571,32223113,Rivaroxaban or Enoxaparin in Nonmajor Orthopedic Surgery.,"BACKGROUND


Nonmajor orthopedic surgery of the lower limbs that results in transient reduced mobility places patients at risk for venous thromboembolism. Rivaroxaban may be noninferior to enoxaparin with regard to the prevention of major venous thromboembolism in these patients.
METHODS


In this international, parallel-group, randomized, double-blind, noninferiority trial, we randomly assigned adult patients undergoing lower-limb nonmajor orthopedic surgery who were considered to be at risk for venous thromboembolism on the basis of the investigator's judgment to receive either rivaroxaban or enoxaparin. The primary efficacy outcome of major venous thromboembolism was a composite of symptomatic distal or proximal deep-vein thrombosis, pulmonary embolism, or venous thromboembolism-related death during the treatment period or asymptomatic proximal deep-vein thrombosis at the end of treatment. A test for superiority was planned if rivaroxaban proved to be noninferior to enoxaparin. For all outcomes, multiple imputation was used to account for missing data. Prespecified safety outcomes included major bleeding (fatal, critical, or clinically overt bleeding or bleeding at the surgical site leading to intervention) and nonmajor clinically relevant bleeding.
RESULTS


A total of 3604 patients underwent randomization; 1809 patients were assigned to receive rivaroxaban, and 1795 to receive enoxaparin. Major venous thromboembolism occurred in 4 of 1661 patients (0.2%) in the rivaroxaban group and in 18 of 1640 patients (1.1%) in the enoxaparin group (risk ratio with multiple imputation, 0.25; 95% confidence interval, 0.09 to 0.75; P<0.001 for noninferiority; P = 0.01 for superiority). The incidence of bleeding did not differ significantly between the rivaroxaban group and the enoxaparin group (1.1% and 1.0%, respectively, for major bleeding or nonmajor clinically relevant bleeding; 0.6% and 0.7%, respectively, for major bleeding).
CONCLUSIONS


Rivaroxaban was more effective than enoxaparin in the prevention of venous thromboembolic events during a period of immobilization after nonmajor orthopedic surgery of the lower limbs. (Funded by Centre Hospitalier Universitaire de Saint-Etienne and Bayer; PRONOMOS ClinicalTrials.gov number, NCT02401594.).",2020,A test for superiority was planned if rivaroxaban proved to be noninferior to enoxaparin.,"['Nonmajor Orthopedic Surgery', '3604 patients underwent randomization; 1809 patients', ""adult patients undergoing lower-limb nonmajor orthopedic surgery who were considered to be at risk for venous thromboembolism on the basis of the investigator's judgment to receive either""]","['enoxaparin', 'Rivaroxaban', 'Rivaroxaban or Enoxaparin', 'rivaroxaban', 'rivaroxaban or enoxaparin']","['venous thromboembolic events', 'incidence of bleeding', 'major venous thromboembolism was a composite of symptomatic distal or proximal deep-vein thrombosis, pulmonary embolism, or venous thromboembolism-related death during the treatment period or asymptomatic proximal deep-vein thrombosis', 'major bleeding or nonmajor clinically relevant bleeding', 'Major venous thromboembolism', 'major bleeding (fatal, critical, or clinically overt bleeding or bleeding at the surgical site leading to intervention) and nonmajor clinically relevant bleeding']","[{'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0022423', 'cui_str': 'Judgment'}]","[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]",3604.0,0.445584,A test for superiority was planned if rivaroxaban proved to be noninferior to enoxaparin.,"[{'ForeName': 'C Marc', 'Initials': 'CM', 'LastName': 'Samama', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Silvy', 'Initials': 'S', 'LastName': 'Laporte', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Rosencher', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Girard', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Llau', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mouret', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Fisher', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martínez-Martín', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Duverger', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Deygas', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Presles', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Cucherat', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mismetti', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1913808']
572,28329211,Therapeutic Vaccine for Genital Herpes Simplex Virus-2 Infection: Findings From a Randomized Trial.,"Background


Genital herpes simplex virus type 2 (HSV-2) infection causes recurrent lesions and frequent viral shedding. GEN-003 is a candidate therapeutic vaccine containing HSV-2 gD2∆TMR and ICP4.2, and Matrix-M2 adjuvant.
Methods


Persons with genital herpes were randomized into 3 dose cohorts to receive 3 intramuscular doses 21 days apart of 10 µg, 30 µg, or 100 µg of GEN-003, antigens without adjuvant, or placebo. Participants obtained genital swab specimens twice daily for HSV-2 detection and monitored genital lesions for 28-day periods at baseline and at intervals after the last dose.
Results


One hundred and thirty-four persons received all 3 doses. Reactogenicity was associated with adjuvant but not with antigen dose or dose number. No serious adverse events were attributed to GEN-003. Compared with baseline, genital HSV-2 shedding rates immediately after dosing were reduced with GEN-003 (from 13.4% to 6.4% for 30 μg [P < .001] and from 15.0% to 10.3% for 100 µg [P < .001]). Lesion rates were also significantly (P < .01) reduced immediately following immunization with 30 µg or 100 µg of GEN-003. GEN-003 elicited increases in antigen binding, virus neutralizing antibody, and T-cell responses.
Conclusions


GEN-003 had an acceptable safety profile and stimulated humoral and cellular immune responses. GEN-003 at doses of 30 µg and 100 µg reduced genital HSV shedding and lesion rates.
Clinical Trials Registration


NCT01667341 (funded by Genocea).",2017,Lesion rates were also significantly (P < .01) reduced immediately following immunization with 30 µg or 100 µg of GEN-003.,"['Methods\n\n\nPersons with genital herpes', 'Genital Herpes Simplex Virus-2 Infection']","['GEN-003', 'GEN-003, antigens without adjuvant, or placebo', 'Therapeutic Vaccine']","['genital HSV-2 shedding rates', 'Reactogenicity', 'Lesion rates', 'genital HSV shedding and lesion rates', 'serious adverse events', 'antigen binding, virus neutralizing antibody, and T-cell responses', 'acceptable safety profile and stimulated humoral and cellular immune responses']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0019342', 'cui_str': 'Herpes Simplex Virus Genital Infection'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]","[{'cui': 'C4521767', 'cui_str': 'US Military Commissioned Officer O10'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0019351', 'cui_str': 'Human Herpesvirus 2'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1817908', 'cui_str': 'Cellular Immune Response'}]",,0.126954,Lesion rates were also significantly (P < .01) reduced immediately following immunization with 30 µg or 100 µg of GEN-003.,"[{'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Bernstein', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, University of Cincinnati, Ohio, USA.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wald', 'Affiliation': 'Vaccine and Fred Hutchinson Cancer Research Center, University of Washington, Seattle, USA.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Warren', 'Affiliation': 'Westover Heights Clinic, Portland, Oregon, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Fife', 'Affiliation': 'Department of Medicine, Indiana University, Indianapolis, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Tyring', 'Affiliation': 'University of Texas Health Science Center and Center for Clinical Studies, Houston, Texas, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Lee', 'Affiliation': 'University of Texas Health Science Center and Center for Clinical Studies, Houston, Texas, USA.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Van Wagoner', 'Affiliation': 'Division of Infectious Diseases, University of Alabama at Birmingham, USA.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Magaret', 'Affiliation': 'Vaccine and Fred Hutchinson Cancer Research Center, University of Washington, Seattle, USA.'}, {'ForeName': 'Jessica B', 'Initials': 'JB', 'LastName': 'Flechtner', 'Affiliation': 'Genocea Biosciences, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Tasker', 'Affiliation': 'Genocea Biosciences, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'Genocea Biosciences, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Morris', 'Affiliation': 'IND 2 Results, Atlanta, Georgia, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Hetherington', 'Affiliation': 'Genocea Biosciences, Cambridge, Massachusetts, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jix004']
573,32107343,Glucocorticoids affect metabolic but not muscle microvascular insulin sensitivity following high versus low salt intake.,"BACKGROUNDSalt-sensitive hypertension is often accompanied by insulin resistance in obese individuals, but the underlying mechanisms are obscure. Microvascular function is known to affect both salt sensitivity of blood pressure and metabolic insulin sensitivity. We hypothesized that excessive salt intake increases blood pressure and decreases insulin-mediated glucose disposal, at least in part by impairing insulin-mediated muscle microvascular recruitment (IMMR).METHODSIn 20 lean and 20 abdominally obese individuals, we assessed mean arterial pressure (MAP; 24-hour ambulatory blood pressure measurements), insulin-mediated whole-body glucose disposal (M/I value; hyperinsulinemic-euglycemic clamp technique), IMMR (contrast-enhanced ultrasound), osmolyte and water balance, and excretion of mineralocorticoids, glucocorticoids, and amino and organic acids after a low- and high-salt diet during 7 days in a randomized, double-blind, crossover design.RESULTSOn a low-, as compared with a high-salt, intake, MAP was lower, M/I value was lower, and IMMR was greater in both lean and abdominally obese individuals. In addition, natural logarithm IMMR was inversely associated with MAP in lean participants on a low-salt diet only. On a high-salt diet, free water clearance decreased, and excretion of glucocorticoids and of amino acids involved in the urea cycle increased.CONCLUSIONOur findings imply that hemodynamic and metabolic changes resulting from alterations in salt intake are not necessarily associated. Moreover, they are consistent with the concept that a high-salt intake increases muscle glucose uptake as a response to high salt-induced, glucocorticoid-driven muscle catabolism to stimulate urea production and thereby renal water conservation.TRIAL REGISTRATIONClinicalTrials.gov, NCT02068781.",2020,"On a low, as compared to a high salt intake, MAP was lower, M/I-value was lower and IMMR was greater in both lean and abdominally obese individuals.","['obese individuals', '20 lean and 20 abdominally obese individuals']","['Glucocorticoids', 'excessive salt intake']","['mean arterial pressure (MAP; 24h ABPM), insulin-mediated whole body glucose disposal (M/I-value; hyperinsulinemic, euglycemic clamp technique), IMMR (contrast enhanced ultrasound), osmolyte and water balance, and excretion of mineralocorticoids, glucocorticoids, and amino and organic acids', 'IMMR', 'excretion of glucocorticoids and of amino acids', 'Ln IMMR', 'blood pressure and decreases insulin-mediated glucose disposal']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C0036140', 'cui_str': 'Salts'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0079318', 'cui_str': 'Glucose Clamp'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C3541395', 'cui_str': 'Mineralocorticoids'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C3541407', 'cui_str': 'Organic acids'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",20.0,0.0497281,"On a low, as compared to a high salt intake, MAP was lower, M/I-value was lower and IMMR was greater in both lean and abdominally obese individuals.","[{'ForeName': 'Monica Tj', 'Initials': 'MT', 'LastName': 'Schütten', 'Affiliation': ''}, {'ForeName': 'Yvo Ham', 'Initials': 'YH', 'LastName': 'Kusters', 'Affiliation': ''}, {'ForeName': 'Alfons Jhm', 'Initials': 'AJ', 'LastName': 'Houben', 'Affiliation': ''}, {'ForeName': 'Hanneke E', 'Initials': 'HE', 'LastName': 'Niessen', 'Affiliation': ''}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': ""Op 't Roodt"", 'Affiliation': ''}, {'ForeName': 'Jean Ljm', 'Initials': 'JL', 'LastName': 'Scheijen', 'Affiliation': ''}, {'ForeName': 'Marjo P', 'Initials': 'MP', 'LastName': 'van de Waardenburg', 'Affiliation': ''}, {'ForeName': 'Casper G', 'Initials': 'CG', 'LastName': 'Schalkwijk', 'Affiliation': ''}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'de Leeuw', 'Affiliation': ''}, {'ForeName': 'Coen DA', 'Initials': 'CD', 'LastName': 'Stehouwer', 'Affiliation': ''}]",JCI insight,['10.1172/jci.insight.127530']
574,32215653,"Histological Evaluation of the Skin After Fat Grafting: A Blinded, Randomized, Controlled Clinical Study.","BACKGROUND


Autologous fat graft is often employed to treat body contour defects. There is currently increased interest in the regenerative properties of fat grafting.
OBJECTIVES


The authors evaluated the histological changes of fat grafting in a blinded randomized controlled trial of staged fat grafting-abdominoplasty.
METHODS


Ten women between 24 and 55 years of age with a body mass index <30 kg/m2 and previous cesarean scar were submitted to fat grafting followed by staged abdominoplasty. The C-section scar served as a landmark for standardization of fat grafting site and control. One side of the abdomen was fat grafted and the other was left intact (control). At the time of abdominoplasty, 4 months later, a full-thickness skin sample from each hemi abdomen (fat-grafted area and control) was collected and sent to histological analysis.
RESULTS


All of the fat-grafted samples showed extracellular lipids and signs of fat graft viability, whereas no such changes occurred in the control group. There were no statistically significant differences in fat-grafted vs control samples regarding skin inflammatory infiltrate (P = 0.582), dermis thickness (P = 0.973), vascular density (P = 0.326), and amount of elastic fibers (P = 1).
CONCLUSIONS


The histological evaluation of women's abdominoplasty surgical site skin after 4 months of fat grafting showed signs of fat graft in 100% of the grafted sides but no change in skin inflammatory infiltrate, dermis thickness, vascularity density, or elastic fiber quantity.",2020,"There were no statistically significant differences in fat-grafted vs control samples regarding skin inflammatory infiltrate (P = 0.582), dermis thickness (P = 0.973), vascular density (P = 0.326), and amount of elastic fibers (P = 1).
",['Ten women between 24 and 55 years of age with a body mass index <30 kg/m2 and previous cesarean scar'],"['Skin', 'fat grafting followed by staged abdominoplasty', 'staged fat grafting-abdominoplasty']","['vascular density', 'extracellular lipids and signs of fat graft viability', 'dermis thickness', 'skin inflammatory infiltrate', 'signs of fat graft', 'amount of elastic fibers', 'skin inflammatory infiltrate, dermis thickness, vascularity density, or elastic fiber quantity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0198542', 'cui_str': 'Abdominoplasty'}, {'cui': 'C1527362', 'cui_str': 'grafts'}]","[{'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0521119', 'cui_str': 'Extracellular (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0011646', 'cui_str': 'Corium'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0332448', 'cui_str': 'Tissue infiltration'}, {'cui': 'C0230899', 'cui_str': 'Elastic Fibers'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}]",10.0,0.0776158,"There were no statistically significant differences in fat-grafted vs control samples regarding skin inflammatory infiltrate (P = 0.582), dermis thickness (P = 0.973), vascular density (P = 0.326), and amount of elastic fibers (P = 1).
","[{'ForeName': 'Juan P B R', 'Initials': 'JPBR', 'LastName': 'Maricevich', 'Affiliation': 'Department of Plastic Surgery, Hospital das Clínicas - UFPE, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Marcel F M B', 'Initials': 'MFMB', 'LastName': 'Lima', 'Affiliation': 'Department of Plastic Surgery, Hospital das Clínicas - UFPE, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Maricevich', 'Affiliation': ''}, {'ForeName': 'Marco A B R', 'Initials': 'MABR', 'LastName': 'Maricevich', 'Affiliation': 'Division of Plastic Surgery, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Larissa F J', 'Initials': 'LFJ', 'LastName': 'Silva', 'Affiliation': 'Department of Pathology, Hospital das Clínicas - UFPE, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Daniela M', 'Initials': 'DM', 'LastName': 'Takano', 'Affiliation': 'Department of Pathology, Hospital das Clínicas - UFPE, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Anlicoara', 'Affiliation': 'Department of Plastic Surgery, Hospital das Clínicas - UFPE, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Álvaro Antônio Bandeira', 'Initials': 'ÁAB', 'LastName': 'Ferraz', 'Affiliation': 'Hospital das Clínicas - UFPE, Recife, Pernambuco, Brazil.'}]",Aesthetic surgery journal,['10.1093/asj/sjz327']
575,32217783,Energy conservation technique improves dyspnoea when patients with severe COPD climb stairs: a randomised crossover study.,"In this randomised, crossover trial, 22 patients with severe chronic obstructive pulmonary disease climbed six flights of stairs (108 steps) twice, under two test conditions: (1) energy conservation technique (ECT): participants were asked to rest for at least 5 seconds every three steps and (2) control condition: participants climbed the stairs at their own pace. Significant lower dyspnoea (primary outcome), leg discomfort, minute ventilation and capillary blood lactate under the ECT condition were found, with no change in total task time. CLINICAL TRIAL REGISTRATION: NCT03564028.",2020,"Significant lower dyspnoea (primary outcome), leg discomfort, minute ventilation and capillary blood lactate under the ECT condition were found, with no change in total task time.","['patients with severe COPD climb stairs', '22 patients with severe chronic obstructive pulmonary disease climbed six flights of stairs (108 steps) twice, under two test conditions: (1']","['Energy conservation technique', 'energy conservation technique (ECT']","['dyspnoea', 'Significant lower dyspnoea (primary outcome), leg discomfort, minute ventilation and capillary blood lactate under the ECT condition', 'total task time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C1290942', 'cui_str': 'Stair Navigation'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease (disorder)'}, {'cui': 'C0561942', 'cui_str': 'Does climb (finding)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0449910', 'cui_str': 'Test conditions (attribute)'}]","[{'cui': 'C1621943', 'cui_str': 'Energy conservation'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]","[{'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0859235', 'cui_str': 'Lower extremities ill feeling of'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood (substance)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",22.0,0.0844287,"Significant lower dyspnoea (primary outcome), leg discomfort, minute ventilation and capillary blood lactate under the ECT condition were found, with no change in total task time.","[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Prieur', 'Affiliation': 'Institute of Experimental and Clinical Research (IREC), Pole of Pulmonology, ORL and Dermatology, Université catholique de Louvain, 1200, Belgium gprieur.kine@gmail.com.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Combret', 'Affiliation': 'Institute of Experimental and Clinical Research (IREC), Pole of Pulmonology, ORL and Dermatology, Université catholique de Louvain, 1200, Belgium.'}, {'ForeName': 'Clement', 'Initials': 'C', 'LastName': 'Medrinal', 'Affiliation': 'Normandie Univ, UNIROUEN, EA3830-GRHV, Institute for Research and Innovation in Biomedicine (IRIB), 76 000 Rouen, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Arnol', 'Affiliation': 'ICADOM, AGIR à dom, Meylan, France.'}, {'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Bonnevie', 'Affiliation': 'Normandie Univ, UNIROUEN, EA3830-GRHV, Institute for Research and Innovation in Biomedicine (IRIB), 76 000 Rouen, France.'}, {'ForeName': 'Francis-Edouard', 'Initials': 'FE', 'LastName': 'Gravier', 'Affiliation': 'Normandie Univ, UNIROUEN, EA3830-GRHV, Institute for Research and Innovation in Biomedicine (IRIB), 76 000 Rouen, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Quieffin', 'Affiliation': 'Pulmonology department and pulmonary rehabilitation department, Groupe Hospitalier du Havre, 76290 Montivilliers, France.'}, {'ForeName': 'Bouchra', 'Initials': 'B', 'LastName': 'Lamia', 'Affiliation': 'Normandie Univ, UNIROUEN, EA3830-GRHV, Institute for Research and Innovation in Biomedicine (IRIB), 76 000 Rouen, France.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Reychler', 'Affiliation': 'Institute of Experimental and Clinical Research (IREC), Pole of Pulmonology, ORL and Dermatology, Université catholique de Louvain, 1200, Belgium.'}, {'ForeName': 'Jean-Christian', 'Initials': 'JC', 'LastName': 'Borel', 'Affiliation': 'R&D, AGIR à dom, Meylan, France.'}]",Thorax,['10.1136/thoraxjnl-2019-214295']
576,32222326,Impacting child health outcomes in congenital heart disease: Cluster randomized controlled trial protocol of in-clinic physical activity counselling.,"BACKGROUND


Most (>90%) children with congenital health defects are not active enough for optimal health. Proactively promoting physical activity during every clinic visit is recommended, but rarely implemented due to a lack of appropriate resources.
METHODS


This cluster randomized controlled trial will implement an evidence-based, multi-faceted physical activity intervention. All eligible patients at small (London, ON), medium (Ottawa, ON) and large (Edmonton, AB) pediatric cardiac clinics will be approached, with randomization to intervention/control by clinic and week. Intervention patients will be counselled with 5 key physical activity messages, have questions about physical activity answered, and have access to a custom web site with personalized activity suggestions and support from a Registered Kinesiologist. The primary outcome is daily physical activity (number of steps, minutes of moderate-to-vigorous activity) assessed via pedometer one week per month for 6-months. Standardized questionnaires assess activity motivation and quality of life at baseline and end of study. Healthcare outcomes will be clinic visit time and contacts for physical activity concerns. Repeated measures ANCOVA will compare control/intervention pedometer outcomes, adjusting for covariates (alpha=0.05).
CONCLUSIONS


This trial aims to determine whether providing resources and protocols enables clinicians to counsel about physical activity as part of every pediatric cardiology appointment. Evaluations of healthcare system impact and intervention delivery in small, medium and large clinics will assess applicability for implementation in all pediatric cardiac clinics. The impact on physical activity motivation and participation will evaluate the effectiveness of this standardized approach for increasing physical activity in children with congenital health defects.",2020,"Evaluations of healthcare system impact and intervention delivery in small, medium and large clinics will assess applicability for implementation in all pediatric cardiac clinics.","['children with congenital health defects', 'Most (>90%) children with congenital health defects', 'all pediatric cardiac clinics', 'All eligible patients at small (London, ON), medium (Ottawa, ON) and large (Edmonton, AB) pediatric cardiac clinics', 'congenital heart disease']",['clinic physical activity counselling'],"['daily physical activity (number of steps, minutes of moderate-to-vigorous activity) assessed via pedometer one week per month for 6-months', 'Standardized questionnaires assess activity motivation and quality of life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0439083', 'cui_str': '>90 (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease (disorder)'}]","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0034380'}]",,0.168498,"Evaluations of healthcare system impact and intervention delivery in small, medium and large clinics will assess applicability for implementation in all pediatric cardiac clinics.","[{'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Lemire', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada; University of Ottawa, Faculty of Medicine, Ottawa, Ontario, Canada.""}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Yaraskavitch', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Lougheed', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada; Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Mackie', 'Affiliation': ""Stollery Children's Hospital, Department of Pediatrics, Division of Cardiology, University of Alberta, Edmonton, Alberta, Canada.""}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Norozi', 'Affiliation': ""Department of Pediatrics, Pediatric Cardiology, Schulich School of Medicine and Dentistry, Western University & Children's Health Research Institute, London, Ontario, Canada; Paediatric Cardiology and Intensive Care Medicine, Medical School Hannover, Germany.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Graham', 'Affiliation': 'Canadian Congenital Heart Alliance, Toronto, Ontario, Canada.'}, {'ForeName': 'Patricia E', 'Initials': 'PE', 'LastName': 'Longmuir', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada; University of Ottawa, Faculty of Medicine, Ottawa, Ontario, Canada. Electronic address: plongmuir@cheo.on.ca.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.105994']
577,32215577,Outcomes of Observation vs Stereotactic Ablative Radiation for Oligometastatic Prostate Cancer: The ORIOLE Phase 2 Randomized Clinical Trial.,"Importance


Complete metastatic ablation of oligometastatic prostate cancer may provide an alternative to early initiation of androgen deprivation therapy (ADT).
Objective


To determine if stereotactic ablative radiotherapy (SABR) improves oncologic outcomes in men with oligometastatic prostate cancer.
Design, Setting, and Participants


The Observation vs Stereotactic Ablative Radiation for Oligometastatic Prostate Cancer (ORIOLE) phase 2 randomized study accrued participants from 3 US radiation treatment facilities affiliated with a university hospital from May 2016 to March 2018 with a data cutoff date of May 20, 2019, for analysis. Of 80 men screened, 54 men with recurrent hormone-sensitive prostate cancer and 1 to 3 metastases detectable by conventional imaging who had not received ADT within 6 months of enrollment or 3 or more years total were randomized.
Interventions


Patients were randomized in a 2:1 ratio to receive SABR or observation.
Main Outcomes and Measures


The primary outcome was progression at 6 months by prostate-specific antigen level increase, progression detected by conventional imaging, symptomatic progression, ADT initiation for any reason, or death. Predefined secondary outcomes were toxic effects of SABR, local control at 6 months with SABR, progression-free survival, Brief Pain Inventory (Short Form)-measured quality of life, and concordance between conventional imaging and prostate-specific membrane antigen (PSMA)-targeted positron emission tomography in the identification of metastatic disease.
Results


In the 54 men randomized, the median (range) age was 68 (61-70) years for patients allocated to SABR and 68 (64-76) years for those allocated to observation. Progression at 6 months occurred in 7 of 36 patients (19%) receiving SABR and 11 of 18 patients (61%) undergoing observation (P = .005). Treatment with SABR improved median progression-free survival (not reached vs 5.8 months; hazard ratio, 0.30; 95% CI, 0.11-0.81; P = .002). Total consolidation of PSMA radiotracer-avid disease decreased the risk of new lesions at 6 months (16% vs 63%; P = .006). No toxic effects of grade 3 or greater were observed. T-cell receptor sequencing identified significant increased clonotypic expansion following SABR and correlation between baseline clonality and progression with SABR only (0.082085 vs 0.026051; P = .03).
Conclusions and Relevance


Treatment with SABR for oligometastatic prostate cancer improved outcomes and was enhanced by total consolidation of disease identified by PSMA-targeted positron emission tomography. SABR induced a systemic immune response, and baseline immune phenotype and tumor mutation status may predict the benefit from SABR. These results underline the importance of prospective randomized investigation of the oligometastatic state with integrated imaging and biological correlates.
Trial Registration


ClinicalTrials.gov Identifier: NCT02680587.",2020,"Treatment with SABR improved median progression-free survival (not reached vs 5.8 months; hazard ratio, 0.30; 95% CI, 0.11-0.81; P = .002).","['Oligometastatic Prostate Cancer', '54 men randomized, the median (range) age was 68 (61-70) years for patients allocated to SABR and 68 (64-76) years for those allocated to observation', '80 men screened, 54 men with recurrent hormone-sensitive prostate cancer and 1 to 3 metastases detectable by conventional imaging who had not received ADT within 6 months of enrollment or 3 or more years total were randomized', 'men with oligometastatic prostate cancer', 'Oligometastatic Prostate Cancer (ORIOLE) phase 2 randomized study accrued participants from 3 US radiation treatment facilities affiliated with a university hospital from May 2016 to March 2018 with a data cutoff date of May 20, 2019, for analysis']","['Observation vs Stereotactic Ablative Radiation', 'stereotactic ablative radiotherapy (SABR', 'conventional imaging and prostate-specific membrane antigen (PSMA)-targeted positron emission tomography', 'SABR or observation', 'androgen deprivation therapy (ADT']","['toxic effects of SABR, local control at 6 months with SABR, progression-free survival, Brief Pain Inventory ', 'median progression-free survival', 'Progression', 'oncologic outcomes', 'clonotypic expansion', 'progression at 6 months by prostate-specific antigen level increase, progression detected by conventional imaging, symptomatic progression, ADT initiation for any reason, or death']","[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1522449', 'cui_str': 'Radiation Treatment'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1310550', 'cui_str': 'prostate-specific membrane antigen, human'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205478', 'cui_str': 'Oncologic (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",54.0,0.211857,"Treatment with SABR improved median progression-free survival (not reached vs 5.8 months; hazard ratio, 0.30; 95% CI, 0.11-0.81; P = .002).","[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Phillips', 'Affiliation': 'Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'William Yue', 'Initials': 'WY', 'LastName': 'Shi', 'Affiliation': 'Stanford Cancer Institute, Department of Radiation Oncology, School of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Deek', 'Affiliation': 'Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Noura', 'Initials': 'N', 'LastName': 'Radwan', 'Affiliation': 'Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Su Jin', 'Initials': 'SJ', 'LastName': 'Lim', 'Affiliation': 'Department of Medical Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Department of Medical Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Rowe', 'Affiliation': 'The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Ross', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Gorin', 'Affiliation': 'The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Curtiland', 'Initials': 'C', 'LastName': 'Deville', 'Affiliation': 'Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Greco', 'Affiliation': 'Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Hailun', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Denmeade', 'Affiliation': 'Department of Medical Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Channing J', 'Initials': 'CJ', 'LastName': 'Paller', 'Affiliation': 'Department of Medical Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Shirl', 'Initials': 'S', 'LastName': 'Dipasquale', 'Affiliation': 'Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Theodore L', 'Initials': 'TL', 'LastName': 'DeWeese', 'Affiliation': 'Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Daniel Y', 'Initials': 'DY', 'LastName': 'Song', 'Affiliation': 'Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Carducci', 'Affiliation': 'Department of Medical Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Pienta', 'Affiliation': 'Department of Medical Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Pomper', 'Affiliation': 'The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Dicker', 'Affiliation': 'Sidney Kimmel Cancer Center, Department of Radiation Oncology, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Mario A', 'Initials': 'MA', 'LastName': 'Eisenberger', 'Affiliation': 'Department of Medical Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Ash A', 'Initials': 'AA', 'LastName': 'Alizadeh', 'Affiliation': 'Stanford Cancer Institute, Division of Oncology, Department of Medicine, School of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Diehn', 'Affiliation': 'Stanford Cancer Institute, Department of Radiation Oncology, School of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Phuoc T', 'Initials': 'PT', 'LastName': 'Tran', 'Affiliation': 'Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}]",JAMA oncology,['10.1001/jamaoncol.2020.0147']
578,30789412,Phase II Trial of Eribulin in Patients With Metastatic Hormone Refractory Prostate Cancer: A Trial of the ECOG-ACRIN Cancer Research Group (E5805).,"BACKGROUND


Eribulin mesylate, a synthetic analog of halichondrin B, is a novel tubulin-binding agent that inhibits cancer cell proliferation at low-nanomolar levels.
METHODS


In a multicenter ECOG trial, patients with progressive metastatic CRPC, ECOG 0-2 were treated with eribulin 1.4 mg/m as an IV bolus over 5 minutes on days 1 and 8 of a 21-day cycle. This noncomparative study stratified points to either a chemonaive (CN), prior-taxane (Tax) only, or 2 prior cytotoxic (TCx) chemotherapy arm. The trial was powered to detect a 50% PSA reduction using Consensus Criteria in at least 40% versus 20% (90% power, one-sided α=0.10) for the CN stratum and 25% versus. 10% (power 87%, one-sided α=0.10) for the Tax and TCx strata.
RESULTS


In total, 119 pts received treatment of which 116 were eligible for the primary response determination in this study. Median age 70 years (range, 45 to 88); median number of treatment cycles 4 (range, 1 to 20+); ECOG 0-1 90%. Confirmed PSA response rates (50% decline from baseline) were 29% (90% [18.2%, 41.2%]; P=0.20), 10% (90% [5.2%, 27.1%]; P=1.00), and 4% ([0.2%, 18.3%]; P=0.59) in the chemonaive stratum, the prior-taxane stratum, and the 2-prior-chemotherapy stratum, respectively. Median progression-free survival was 3.5 months (95% CI, 2.0, 5.9), 2.3 months (95% CI, 2.0, 2.9) and 3.7 months (95% CI, 2.1, 4.2) for the chemonaive stratum, the prior-taxane stratum and the 2-prior-chemotherapy stratum, respectively. Nonhematological toxicities of any grade (mainly grade 1 and 2) were fatigue (74%), neuropathy (40%), alopecia (39%), nausea (35%), and anorexia (34%). Common hematological toxicities were decreased leukocytes (75%), decreased neutrophils (72%), and decreased hemoglobin (66%). The most common grade ≥ 3 toxicities were decreased neutrophils (55%), decreased leukocytes (42%), sensory neuropathy (13%), and fatigue (11%). Overall, there was a 4% rate of febrile neutropenia.
CONCLUSIONS


In summary, per the prespecified study endpoints, eribulin did not have adequate activity in chemotherapy naïve or chemotherapy pretreated patients with metastatic CRPC to support further study in this setting.",2019,"Median progression-free survival was 3.5 months (95% CI, 2.0, 5.9), 2.3 months (95% CI, 2.0, 2.9) and 3.7 months (95% CI, 2.1, 4.2) for the chemonaive stratum, the prior-taxane stratum and the 2-prior-chemotherapy stratum, respectively.","['Patients With Metastatic Hormone Refractory Prostate Cancer', '119 pts received treatment of which 116 were eligible for the primary response determination in this study', 'patients with progressive metastatic CRPC, ECOG 0-2', 'Median age 70 years (range, 45 to 88); median number of treatment cycles 4 (range, 1 to 20+); ECOG 0-1 90']","['chemonaive (CN), prior-taxane (Tax) only, or 2 prior cytotoxic (TCx) chemotherapy arm']","['sensory neuropathy', 'febrile neutropenia', 'Common hematological toxicities', 'Median progression-free survival', 'nausea', 'hemoglobin', 'Nonhematological toxicities', 'anorexia', 'decreased neutrophils', 'PSA response rates', 'neuropathy', 'decreased leukocytes', 'alopecia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1148554', 'cui_str': 'determination'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0430797', 'cui_str': 'Intracranial EEG'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]","[{'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C4521706', 'cui_str': 'Cytotoxic'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0151313', 'cui_str': 'Sensory neuropathy (disorder)'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}]",,0.0596564,"Median progression-free survival was 3.5 months (95% CI, 2.0, 5.9), 2.3 months (95% CI, 2.0, 2.9) and 3.7 months (95% CI, 2.1, 4.2) for the chemonaive stratum, the prior-taxane stratum and the 2-prior-chemotherapy stratum, respectively.","[{'ForeName': 'Mark N', 'Initials': 'MN', 'LastName': 'Stein', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Yu-Hui', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Carducci', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Hudes', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Pauline M', 'Initials': 'PM', 'LastName': 'Lerma', 'Affiliation': 'Campbell County Health, Gillette, WY.'}, {'ForeName': 'Winston W', 'Initials': 'WW', 'LastName': 'Tan', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dalune', 'Affiliation': 'Minnesota Oncology, Maplewood, MN.'}, {'ForeName': 'Kendrith M', 'Initials': 'KM', 'LastName': 'Rowland', 'Affiliation': 'Carle Clinic, Champaign.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Kuzel', 'Affiliation': 'Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'DiPaola', 'Affiliation': 'University of Kentucky, Lexington, KY.'}]",American journal of clinical oncology,['10.1097/COC.0000000000000526']
579,31428863,Effects of the nontourniquet combined with controlled hypotension technique on pain and long-term prognosis in elderly patients after total knee arthroplasty: a randomized controlled study.,"PURPOSE


The aim of this study was to confirm the alleviating effects of the nontourniquet technique on the postoperative acute and chronic pain of patients after total knee arthroplasty (TKA).
METHODS


122 elderly patients undergoing TKA were randomly divided into two groups: group T (n = 58) and group H (n = 64). An electronic inflatable tourniquet was used during TKA in group T. The patients in group H received controlled hypotension but without tourniquet use during the operation. The numeric rating scale (NRS) score was used to evaluate pain level on day 1, day 2, day 3 and day 7 after the operation, and the incidence of chronic pain was judged at 3-month and 1-year follow-ups, and functional recovery of the knee joint was estimated by the active range of knee joint motion (AROM) at the same time points. Cognitive function was assessed by the montreal cognitive assessment scale (MoCA) for 7 days after operation.
RESULTS


There were no significant differences in the NRS scores and AROM for 7 days after surgery. The incidence rate of chronic pain in group H (25.0%) was lower than that in group T (41.4%) and the AROM in group H was greater at one year follow-up. The MoCA score in group H was lower than that in group T on day 1 and day 2.
CONCLUSION


The nontourniquet combined with controlled hypotension technique can alleviate chronic pain and promote the long-term rehabilitation of patients after TKA.",2019,"The MoCA score in group H was lower than that in group T on day 1 and day 2.
","['patients after TKA', 'elderly patients after total knee arthroplasty', 'patients after total knee arthroplasty (TKA', '122 elderly patients undergoing TKA']","['nontourniquet combined with controlled hypotension technique', 'nontourniquet technique', 'controlled hypotension technique']","['Cognitive function', 'active range of knee joint motion (AROM', 'montreal cognitive assessment scale (MoCA', 'controlled hypotension', 'incidence rate of chronic pain', 'chronic pain', 'pain level', 'numeric rating scale (NRS) score', 'MoCA score', 'incidence of chronic pain', 'pain and long-term prognosis', 'postoperative acute and chronic pain', 'NRS scores and AROM']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0020650', 'cui_str': 'Hypotension, Induced'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C3496286'}, {'cui': 'C0222045'}, {'cui': 'C0020650', 'cui_str': 'Hypotension, Induced'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",122.0,0.0366645,"The MoCA score in group H was lower than that in group T on day 1 and day 2.
","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, No. 1 Youyi Road, Yuzhong District, Chongqing, China. dongjun441@163.com.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Min', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, No. 1 Youyi Road, Yuzhong District, Chongqing, China.'}, {'ForeName': 'Kai-Hua', 'Initials': 'KH', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, No. 1 Youyi Road, Yuzhong District, Chongqing, China.'}, {'ForeName': 'Li-Hua', 'Initials': 'LH', 'LastName': 'Peng', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, No. 1 Youyi Road, Yuzhong District, Chongqing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, No. 1 Youyi Road, Yuzhong District, Chongqing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ran', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, No. 1 Youyi Road, Yuzhong District, Chongqing, China.'}]",Journal of anesthesia,['10.1007/s00540-019-02671-z']
580,31435739,Rocuronium Bromide Intravenous Solution Maruishi® is more suitable than ESLAX Intravenous® during rapid-sequence induction of anesthesia.,"PURPOSE


Rocuronium Bromide Intravenous Solution® (Maruishi Pharmaceutical Co., Ltd, Osaka, Japan) is a newly developed generic drug and we have noticed that compared with conventional rocuronium formulations [e.g. Esmeron (Eslax), MSD Co. Ltd., Tokyo, Japan], rocuronium Maruishi appeared to cause less pain or withdrawal movement. The aim of this study was to assess the hypothesis that the injection of rocuronium Maruishi causes less body movement than rocuronium MSD does, during rapid-sequence induction of anesthesia.
METHODS


Sixty patients were allocated randomly to one of two groups. In one group, rocuronium MSD was used and in the other group, rocuronium Maruishi was used. After induction of general anesthesia, a test drug (containing rocuronium) 0.9 mg/kg was injected. Patient's withdrawal movement was graded with the scale. Primary outcome measure was the incidence of moderate or severe movement after the injection of rocuronium. Secondary outcome measure was the degree of movement between the groups.
RESULTS


Moderate or severe withdrawal movement was observed after the injection of rocuronium MSD in 11 of 30 patients (37%) and after the injection of rocuronium Maruishi in 3 of 30 patients (10%). There was a significant difference in the incidence between the groups (P = 0.013, 95% CI for difference 26-28%). The degree of movement was also significantly greater for rocuronium MSD than for rocuronium Maruishi (P = 0.015).
CONCLUSION


Compared with rocuronium MSD, rocuronium Maruishi is more suitable than conventional rocuronium formulations, for rapid-sequence induction of anesthesia.",2019,"Compared with rocuronium MSD, rocuronium Maruishi is more suitable than conventional rocuronium formulations, for rapid-sequence induction of anesthesia.",['Sixty patients'],"['Rocuronium Bromide Intravenous Solution Maruishi®', 'Rocuronium Bromide Intravenous Solution®', 'rocuronium', 'rocuronium MSD, rocuronium Maruishi', 'rocuronium MSD']","['degree of movement between the groups', ""Patient's withdrawal movement"", 'Moderate or severe withdrawal movement', 'degree of movement', 'incidence of moderate or severe movement after the injection of rocuronium']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0069632', 'cui_str': 'rocuronium bromide'}, {'cui': 'C0991514', 'cui_str': 'Intravenous solution (qualifier value)'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}]",60.0,0.404565,"Compared with rocuronium MSD, rocuronium Maruishi is more suitable than conventional rocuronium formulations, for rapid-sequence induction of anesthesia.","[{'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Tachikawa', 'Affiliation': 'Department of Anesthesiology, Dokkyo Medical University Saitama Medical Center, 2-1-50 Minamikoshigaya, Koshigaya City, 343-8555, Saitama, Japan. tachi@dokkyomed.ac.jp.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Asai', 'Affiliation': 'Department of Anesthesiology, Dokkyo Medical University Saitama Medical Center, 2-1-50 Minamikoshigaya, Koshigaya City, 343-8555, Saitama, Japan.'}, {'ForeName': 'Yasuhisa', 'Initials': 'Y', 'LastName': 'Okuda', 'Affiliation': 'Department of Anesthesiology, Dokkyo Medical University Saitama Medical Center, 2-1-50 Minamikoshigaya, Koshigaya City, 343-8555, Saitama, Japan.'}]",Journal of anesthesia,['10.1007/s00540-019-02673-x']
581,32217876,Neurally Adjusted Ventilatory Assist versus Pressure Support Ventilation in Difficult Weaning: A Randomized Trial.,"BACKGROUND


Difficult weaning frequently develops in ventilated patients and is associated with poor outcome. In neurally adjusted ventilatory assist, the ventilator is controlled by diaphragm electrical activity, which has been shown to improve patient-ventilator interaction. The objective of this study was to compare neurally adjusted ventilatory assist and pressure support ventilation in patients difficult to wean from mechanical ventilation.
METHODS


In this nonblinded randomized clinical trial, difficult-to-wean patients (n = 99) were randomly assigned to neurally adjusted ventilatory assist or pressure support ventilation mode. The primary outcome was the duration of weaning. Secondary outcomes included the proportion of successful weaning, patient-ventilator asynchrony, ventilator-free days, and mortality. Weaning duration was calculated as 28 days for patients under mechanical ventilation at day 28 or deceased before day 28 without successful weaning.
RESULTS


Weaning duration in all patients was statistically significant shorter in the neurally adjusted ventilatory assist group (n = 47) compared with the pressure support ventilation group (n = 52; 3.0 [1.2 to 8.0] days vs. 7.4 [2.0 to 28.0], mean difference: -5.5 [95% CI, -9.2 to -1.4], P = 0.039). Post hoc sensitivity analysis also showed that the neurally adjusted ventilatory assist group had shorter weaning duration (hazard ratio, 0.58; 95% CI, 0.34 to 0.98). The proportion of patients with successful weaning from invasive mechanical ventilation was higher in neurally adjusted ventilatory assist (33 of 47 patients, 70%) compared with pressure support ventilation (25 of 52 patients, 48%; respiratory rate for neurally adjusted ventilatory assist: 1.46 [95% CI, 1.04 to 2.05], P = 0.026). The number of ventilator-free days at days 14 and 28 was statistically significantly higher in neurally adjusted ventilatory assist compared with pressure support ventilation. Neurally adjusted ventilatory assist improved patient ventilator interaction. Mortality and length of stay in the intensive care unit and in the hospital were similar among groups.
CONCLUSIONS


In patients difficult to wean, neurally adjusted ventilatory assist decreased the duration of weaning and increased ventilator-free days.",2020,Weaning duration in all patients was statistically significant shorter in the neurally adjusted ventilatory assist group (n = 47) compared with the pressure support ventilation group (n = 52,"['patients difficult to wean from mechanical ventilation', 'wean patients (n = 99', 'ventilated patients', 'Difficult Weaning']","['neurally adjusted ventilatory assist and pressure support ventilation', 'Neurally Adjusted Ventilatory Assist versus Pressure Support Ventilation', 'neurally adjusted ventilatory assist or pressure support ventilation mode', 'pressure support ventilation']","['shorter weaning duration', 'proportion of successful weaning, patient-ventilator asynchrony, ventilator-free days, and mortality', 'proportion of patients with successful weaning from invasive mechanical ventilation', 'Mortality and length of stay', 'patient ventilator interaction', 'respiratory rate', 'number of ventilator-free days', 'Weaning duration', 'duration of weaning', 'pressure support ventilation', 'duration of weaning and increased ventilator-free days']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}]","[{'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",99.0,0.15027,Weaning duration in all patients was statistically significant shorter in the neurally adjusted ventilatory assist group (n = 47) compared with the pressure support ventilation group (n = 52,"[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'From the Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, 210009, Jiangsu, China (L.L., X.X., Q.S., Y. Yu., F.X., J.X., Y. Yang, H.Q.) the Department of Intensive Care, Amsterdam University Medical Center, Amsterdam, The Netherlands (L.H.).'}, {'ForeName': 'Xiaoting', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Feiping', 'Initials': 'F', 'LastName': 'Xia', 'Affiliation': ''}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Heunks', 'Affiliation': ''}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Qiu', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003207']
582,32221866,Efficacy and Safety of Diclofenac + Capsaicin Gel in Patients with Acute Back/Neck Pain: A Multicenter Randomized Controlled Study.,"INTRODUCTION


Back and neck pain are common musculoskeletal disorders. Topical non-steroidal anti-inflammatory drugs (NSAIDs) are frequently used to reduce pain and inflammation with fewer systemic side effects and drug interactions compared with oral NSAIDs. This study assessed efficacy and tolerability of a topical combination of capsaicin + diclofenac to treat acute back/neck pain.
METHODS


In a randomized, double-blind, controlled, multicenter, parallel group trial, 746 patients were treated twice-daily for 5 days with diclofenac 2% + capsaicin 0.075%, diclofenac 2%, capsaicin 0.075% or placebo. Efficacy assessments included change and area under the curve in pain on movement for the worst procedure (POM WP ), change in pressure algometry, and number of patients with decrease in POM WP  of ≥ 30% and ≥ 50%. Adverse events (AEs) were recorded.
RESULTS


Change in POM WP  between baseline and day 2 evening, 1 h after drug application, demonstrates superiority of the combination (- 3.05 cm) versus diclofenac alone (- 2.33 cm) and placebo (- 2.45 cm), but not capsaicin alone (- 3.26 cm). AEs were consistent with known safety profiles.
CONCLUSION


Capsaicin alone and capsaicin + diclofenac showed superior benefit compared with placebo. However, diclofenac alone demonstrated efficacy comparable with placebo, and therefore its addition to capsaicin added no increased pain relief over capsaicin alone.
TRIAL REGISTRATION


ClinicalTrials.gov identifier; NCT02700815.",2020,+ diclofenac showed superior benefit compared with placebo.,"['746 patients', 'Patients with Acute Back', 'Neck Pain']","['diclofenac 2%\u2009+\u2009capsaicin 0.075%, diclofenac 2%, capsaicin 0.075% or placebo', 'placebo', 'Diclofenac\u2009+\u2009Capsaicin Gel', 'diclofenac', 'Capsaicin alone and capsaicin', 'capsaicin', 'Topical non-steroidal anti-inflammatory drugs (NSAIDs', 'capsaicin\u2009+\u2009diclofenac', '\u2009diclofenac']","['Efficacy and Safety', 'pain relief', 'change and area under the curve in pain on movement for the worst procedure (POM WP ), change in pressure algometry, and number of patients with decrease in POM WP', 'Adverse events (AEs', 'efficacy and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C4517416', 'cui_str': '0.075'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",746.0,0.670048,+ diclofenac showed superior benefit compared with placebo.,"[{'ForeName': 'Hans-Georg', 'Initials': 'HG', 'LastName': 'Predel', 'Affiliation': 'Institute for Cardiology and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Caty', 'Initials': 'C', 'LastName': 'Ebel-Bitoun', 'Affiliation': 'Consumer Health Care, Sanofi-Aventis, Paris, France.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Peil', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Weiser', 'Affiliation': 'Consumer Health Care, Medical Affairs, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lange', 'Affiliation': 'Consumer Health Care, Global Medical Affairs, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany. robert1.lange@sanofi.com.'}]",Pain and therapy,['10.1007/s40122-020-00161-9']
583,32222134,Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction.,"BACKGROUND


The effect of vericiguat, a novel oral soluble guanylate cyclase stimulator, in patients with heart failure and reduced ejection fraction who had recently been hospitalized or had received intravenous diuretic therapy is unclear.
METHODS


In this phase 3, randomized, double-blind, placebo-controlled trial, we assigned 5050 patients with chronic heart failure (New York Heart Association class II, III, or IV) and an ejection fraction of less than 45% to receive vericiguat (target dose, 10 mg once daily) or placebo, in addition to guideline-based medical therapy. The primary outcome was a composite of death from cardiovascular causes or first hospitalization for heart failure.
RESULTS


Over a median of 10.8 months, a primary-outcome event occurred in 897 of 2526 patients (35.5%) in the vericiguat group and in 972 of 2524 patients (38.5%) in the placebo group (hazard ratio, 0.90; 95% confidence interval [CI], 0.82 to 0.98; P = 0.02). A total of 691 patients (27.4%) in the vericiguat group and 747 patients (29.6%) in the placebo group were hospitalized for heart failure (hazard ratio, 0.90; 95% CI, 0.81 to 1.00). Death from cardiovascular causes occurred in 414 patients (16.4%) in the vericiguat group and in 441 patients (17.5%) in the placebo group (hazard ratio, 0.93; 95% CI, 0.81 to 1.06). The composite of death from any cause or hospitalization for heart failure occurred in 957 patients (37.9%) in the vericiguat group and in 1032 patients (40.9%) in the placebo group (hazard ratio, 0.90; 95% CI, 0.83 to 0.98; P = 0.02). Symptomatic hypotension occurred in 9.1% of the patients in the vericiguat group and in 7.9% of the patients in the placebo group (P = 0.12), and syncope occurred in 4.0% of the patients in the vericiguat group and in 3.5% of the patients in the placebo group (P = 0.30).
CONCLUSIONS


Among patients with high-risk heart failure, the incidence of death from cardiovascular causes or hospitalization for heart failure was lower among those who received vericiguat than among those who received placebo. (Funded by Merck Sharp & Dohme [a subsidiary of Merck] and Bayer; VICTORIA ClinicalTrials.gov number, NCT02861534.).",2020,"Among patients with high-risk heart failure, the incidence of death from cardiovascular causes or hospitalization for heart failure was lower among those who received vericiguat than among those who received placebo.","['patients with high-risk heart failure', 'patients with heart failure and reduced ejection fraction who had recently been hospitalized or had received', 'Patients with Heart Failure and Reduced Ejection Fraction', '5050 patients with chronic heart failure (New York Heart Association class II, III, or IV) and an ejection fraction of less than 45% to receive']","['vericiguat (target dose, 10 mg once daily) or placebo, in addition to guideline-based medical therapy', 'placebo', 'intravenous diuretic therapy']","['syncope', 'Death from cardiovascular causes', 'Symptomatic hypotension', 'composite of death from cardiovascular causes or first hospitalization for heart failure', 'death from cardiovascular causes or hospitalization for heart failure', 'hospitalized for heart failure', 'composite of death from any cause or hospitalization for heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0948575', 'cui_str': 'Diuretic therapy'}]","[{'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",5050.0,0.580875,"Among patients with high-risk heart failure, the incidence of death from cardiovascular causes or hospitalization for heart failure was lower among those who received vericiguat than among those who received placebo.","[{'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Ezekowitz', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Jia', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'McNulty', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Mahesh J', 'Initials': 'MJ', 'LastName': 'Patel', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Roessig', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Koglin', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915928']
584,32108181,Eating breakfast and avoiding late-evening snacking sustains lipid oxidation.,"Circadian (daily) regulation of metabolic pathways implies that food may be metabolized differentially over the daily cycle. To test that hypothesis, we monitored the metabolism of older subjects in a whole-room respiratory chamber over two separate 56-h sessions in a random crossover design. In one session, one of the 3 daily meals was presented as breakfast, whereas in the other session, a nutritionally equivalent meal was presented as a late-evening snack. The duration of the overnight fast was the same for both sessions. Whereas the two sessions did not differ in overall energy expenditure, the respiratory exchange ratio (RER) was different during sleep between the two sessions. Unexpectedly, this difference in RER due to daily meal timing was not due to daily differences in physical activity, sleep disruption, or core body temperature (CBT). Rather, we found that the daily timing of nutrient availability coupled with daily/circadian control of metabolism drives a switch in substrate preference such that the late-evening Snack Session resulted in significantly lower lipid oxidation (LO) compared to the Breakfast Session. Therefore, the timing of meals during the day/night cycle affects how ingested food is oxidized or stored in humans, with important implications for optimal eating habits.",2020,"Whereas the two sessions did not differ in overall energy expenditure, the respiratory exchange ratio (RER) was different during sleep between the two sessions.",[],['Eating breakfast and avoiding late-evening snacking sustains lipid oxidation'],"['overall energy expenditure, the respiratory exchange ratio (RER', 'physical activity, sleep disruption, or core body temperature (CBT', 'RER', 'duration of the overnight fast', 'lipid oxidation (LO']",[],"[{'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332453', 'cui_str': 'Disruption (morphologic abnormality)'}, {'cui': 'C0456240', 'cui_str': 'Core body temperature (observable entity)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}]",,0.0309961,"Whereas the two sessions did not differ in overall energy expenditure, the respiratory exchange ratio (RER) was different during sleep between the two sessions.","[{'ForeName': 'Kevin Parsons', 'Initials': 'KP', 'LastName': 'Kelly', 'Affiliation': 'Department of Biological Sciences, Vanderbilt University, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Owen P', 'Initials': 'OP', 'LastName': 'McGuinness', 'Affiliation': 'Department of Molecular Physiology and Biophysics, Vanderbilt University School of Medicine, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Buchowski', 'Affiliation': 'Division of Gastroenterology, Hepatology, & Nutrition, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Jacob J', 'Initials': 'JJ', 'LastName': 'Hughey', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Powers', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Page', 'Affiliation': 'Department of Biological Sciences, Vanderbilt University, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Carl Hirschie', 'Initials': 'CH', 'LastName': 'Johnson', 'Affiliation': 'Department of Biological Sciences, Vanderbilt University, Nashville, Tennessee, United States of America.'}]",PLoS biology,['10.1371/journal.pbio.3000622']
585,32217780,Cost-effectiveness of positive airway pressure modalities in obesity hypoventilation syndrome with severe obstructive sleep apnoea.,"BACKGROUND


Obesity hypoventilation syndrome (OHS) is treated with either non-invasive ventilation (NIV) or CPAP, but there are no long-term cost-effectiveness studies comparing the two treatment modalities.
OBJECTIVES


We performed a large, multicentre, randomised, open-label controlled study to determine the comparative long-term cost and effectiveness of NIV versus CPAP in patients with OHS with severe obstructive sleep apnoea (OSA) using hospitalisation days as the primary outcome measure.
METHODS


Hospital resource utilisation and within trial costs were evaluated against the difference in effectiveness based on the primary outcome (hospitalisation days/year, transformed and non-transformed in monetary term). Costs and effectiveness were estimated from a log-normal distribution using a Bayesian approach. A secondary analysis by adherence subgroups was performed.
RESULTS


In total, 363 patients were selected, 215 were randomised and 202 were available for the analysis. The median (IQR) follow-up was 3.01 (2.91-3.14) years for NIV group and 3.00 (2.92-3.17) years for CPAP. The mean (SD) Bayesian estimated hospital days was 2.13 (0.73) for CPAP and 1.89 (0.78) for NIV. The mean (SD) Bayesian estimated cost per patient/year in the NIV arm, excluding hospitalisation costs, was €2075.98 (91.6), which was higher than the cost in the CPAP arm of €1219.06 (52.3); mean difference €857.6 (105.5). CPAP was more cost-effective than NIV (99.5% probability) because longer hospital stay in the CPAP arm was compensated for by its lower costs. Similar findings were observed in the high and low adherence subgroups.
CONCLUSION


CPAP is more cost-effective than NIV; therefore, CPAP should be the preferred treatment for patients with OHS with severe OSA.
TRIAL REGISTRATION NUMBER


NCT01405976.",2020,CPAP was more cost-effective than NIV (99.5% probability) because longer hospital stay in the CPAP arm was compensated for by its lower costs.,"['363 patients were selected, 215 were randomised and 202 were available for the analysis', 'obesity hypoventilation syndrome with severe obstructive sleep apnoea', 'patients with OHS with severe OSA', 'patients with OHS with severe obstructive sleep apnoea (OSA']","['CPAP', 'non-invasive ventilation (NIV) or CPAP', 'NIV versus CPAP', 'positive airway pressure modalities']","['mean (SD) Bayesian estimated cost per patient/year in the NIV arm, excluding hospitalisation costs', 'Costs and effectiveness', 'hospital stay', 'mean (SD) Bayesian estimated hospital days']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0031880', 'cui_str': 'Obesity Hypoventilation Syndrome'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",363.0,0.132362,CPAP was more cost-effective than NIV (99.5% probability) because longer hospital stay in the CPAP arm was compensated for by its lower costs.,"[{'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Masa', 'Affiliation': 'Respiratory Department, San Pedro de Alcantara Hospital, Caceres, Spain fmasa@separ.es.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Mokhlesi', 'Affiliation': 'Instituto Universitario deInvestigación Biosanitaria de Extremadura (INUBE), Romero, Auxiliadora.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Benítez', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Gómez de Terreros Caro', 'Affiliation': 'Respiratory Department, San Pedro de Alcantara Hospital, Caceres, Spain.'}, {'ForeName': 'M-Ángeles', 'Initials': 'MÁ', 'LastName': 'Sánchez-Quiroga', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Auxiliadora', 'Initials': 'A', 'LastName': 'Romero', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Candela', 'Initials': 'C', 'LastName': 'Caballero', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Maria Luz', 'Initials': 'ML', 'LastName': 'Alonso-Álvarez', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Estrella', 'Initials': 'E', 'LastName': 'Ordax-Carbajo', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gómez-García', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'González', 'Affiliation': 'Respiratory Department, Valdecilla Hospital, Santander, Spain.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'López-Martín', 'Affiliation': 'Respiratory Department, Gregorio Marañon Hospital, Madrid, Spain.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Marin', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Sergi', 'Initials': 'S', 'LastName': 'Martí', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Trinidad', 'Initials': 'T', 'LastName': 'Díaz-Cambriles', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Eusebi', 'Initials': 'E', 'LastName': 'Chiner', 'Affiliation': 'Respiratory Department, San Juan Hospital, Alicante, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Egea', 'Affiliation': 'Respiratory Department, Gregorio Marañon Hospital, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Barca', 'Affiliation': 'Institut de Recerca Biomédica de LLeida (IRBLLEIDA), Lleida, Spain.'}, {'ForeName': 'Francisco-José', 'Initials': 'FJ', 'LastName': 'Vázquez-Polo', 'Affiliation': 'Department of Quantitative Methods, University of Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Negrín', 'Affiliation': 'Department of Quantitative Methods, University of Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Martel-Escobar', 'Affiliation': 'Department of Quantitative Methods, University of Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Barbé', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Corral-Peñafiel', 'Affiliation': 'Respiratory Department, San Pedro de Alcantara Hospital, Caceres, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Thorax,['10.1136/thoraxjnl-2019-213622']
586,31466618,Natriuretic Peptide Response and Outcomes in Chronic Heart Failure With Reduced Ejection Fraction.,"BACKGROUND


The GUIDE-IT (GUIDing Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure) trial demonstrated that a strategy to ""guide"" application of guideline-directed medical therapy (GDMT) by reducing amino-terminal pro-B-type natriuretic peptide (NT-proBNP) was not superior to GDMT alone.
OBJECTIVES


The purpose of this study was to examine the prognostic meaning of NT-proBNP changes following heart failure (HF) therapy intensification relative to the goal NT-proBNP value of 1,000 pg/ml explored in the GUIDE-IT trial.
METHODS


A total of 638 study participants were included who were alive and had available NT-proBNP results 90 days after randomization. Rates of subsequent cardiovascular (CV) death/HF hospitalization or all-cause mortality during follow-up and Kansas City Cardiomyopathy Questionnaire (KCCQ) overall scores were analyzed.
RESULTS


A total of 198 (31.0%) subjects had an NT-proBNP ≤1,000 pg/ml at 90 days with no difference in achievement of NT-proBNP goal between the biomarker-guided and usual care arms. NT-proBNP ≤1,000 pg/ml by 90 days was associated with longer freedom from CV/HF hospitalization or all-cause mortality (p < 0.001 for both) and lower adjusted hazard of subsequent HF hospitalization/CV death (hazard ratio: 0.26; 95% confidence interval: 0.15 to 0.46; p < 0.001) and all-cause mortality (hazard ratio: 0.34; 95% confidence interval: 0.15 to 0.77; p = 0.009). Regardless of elevated baseline concentration, an NT-proBNP ≤1,000 pg/ml at 90 days was associated with better outcomes and significantly better KCCQ overall scores (p = 0.02).
CONCLUSIONS


Patients with heart failure with reduced ejection fraction whose NT-proBNP levels decreased to ≤1,000 pg/ml during GDMT had better outcomes. These findings may help to understand the results of the GUIDE-IT trial. (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment [GUIDE-IT]; NCT01685840).",2019,pg/ml by 90 days was associated with longer freedom from CV/HF hospitalization or all-cause mortality (p < 0.001 for both) and lower adjusted hazard of subsequent HF hospitalization/CV death (hazard ratio: 0.26; 95% confidence interval: 0.15 to 0.46; p < 0.001) and all-cause mortality (hazard ratio: 0.34; 95% confidence interval: 0.15 to 0.77; p = 0.009).,"['Heart\xa0Failure', 'A total of 638 study participants were included who were alive and had available NT-proBNP results 90\xa0days after randomization']",['guideline-directed medical therapy (GDMT'],"['longer freedom from CV/HF hospitalization or all-cause mortality', 'Rates of subsequent cardiovascular (CV) death/HF hospitalization or all-cause mortality', 'Cardiomyopathy Questionnaire (KCCQ) overall scores', 'NT-proBNP levels', 'KCCQ overall scores']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",638.0,0.212442,pg/ml by 90 days was associated with longer freedom from CV/HF hospitalization or all-cause mortality (p < 0.001 for both) and lower adjusted hazard of subsequent HF hospitalization/CV death (hazard ratio: 0.26; 95% confidence interval: 0.15 to 0.46; p < 0.001) and all-cause mortality (hazard ratio: 0.34; 95% confidence interval: 0.15 to 0.77; p = 0.009).,"[{'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Januzzi', 'Affiliation': 'Cardiology Division, Massachusetts General Hospital, Baim Institute for Clinical Research, Boston, Massachusetts. Electronic address: JJanuzzi@partners.org.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Ahmad', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University Medical Center, New Haven, Connecticut.'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Mulder', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Coles', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Kirkwood F', 'Initials': 'KF', 'LastName': 'Adams', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Ezekowitz', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, California.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Fiuzat', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Houston-Miller', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Ileana L', 'Initials': 'IL', 'LastName': 'Piña', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Gayle', 'Initials': 'G', 'LastName': 'Passmore', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Whellan', 'Affiliation': 'Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Lawton S', 'Initials': 'LS', 'LastName': 'Cooper', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Leifer', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Center, Fairfax, Virginia.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.06.055']
587,31468177,Use of a curved needle to facilitate lateral sagittal infraclavicular block performance: a randomized clinical trial.,"PURPOSE


Failed needle-tip positioning in an ultrasound-guided infraclavicular block can be due to improper needle insertion point and steep needle insertion angle. Needle pre-curving enables the user to pass the needle with different curved trajectories on approaching the brachial plexus. Aim of the study was to compare curved and non-curved needles as regards the time needed to perform the lateral sagittal infra-clavicular block.
METHODS


Sixty-nine patients undergoing surgery distal to the elbow were randomly allocated to two groups: group A (n = 35), which received ultrasound-guided infraclavicular block using the curved needle; and group B (n = 34), which received the infraclavicular block using the non-curved needle. The primary outcome measure was the time needed to perform the infraclavicular block. Anesthetist's experience with the curved vs. non-curved needle was noted.
RESULTS


Mean (SD) recognition time (120 ± 48 vs. 179 ± 72 s, P = 0.0002) and injection time (54 ± 23 vs. 88 ± 36 s, P = 0.0001) were shorter in group A compared to group B. Median (IQR) procedure pain score was less in group A 2 (1-2) than in group B 2 (2-3); P = 0.001. Median (IQR) satisfaction score was higher with regards to the curved needle 4 (4-5) than non-curved needle 3 (3-4) in performing infraclavicular blockade; P = 0.001.
CONCLUSION


The use of a curved needle reduces the time required to perform the lateral sagittal infraclavicular block. The curved needle provides less procedure pain and higher satisfaction levels among anesthetists than the non-curved needle.
TRIAL REGISTRATION


The trial was registered (04/26/2016) with the ClinicalTrials.gov ID: NCT02799576. Approval Number: #2543. Board Name: Research Ethics Committee. Board Affiliation: Suez Canal University, Faculty of Medicine, Suez Canal University hospital, Ismailia, Egypt, 41522.",2019,"Mean (SD) recognition time (120 ± 48 vs. 179 ± 72 s, P = 0.0002) and injection time (54 ± 23 vs. 88 ± 36 s, P = 0.0001) were shorter in group A compared to group B. Median (IQR) procedure pain score was less in group A 2 (1-2) than in group B 2 (2-3);",['Sixty-nine patients undergoing surgery distal to the elbow'],"['ultrasound-guided infraclavicular block using the curved needle', 'curved needle to facilitate lateral sagittal infraclavicular block performance', 'infraclavicular block using the non-curved needle']","['time needed to perform the infraclavicular block', 'Median (IQR) procedure pain score', 'injection time', 'Median (IQR) satisfaction score', 'Mean (SD) recognition time']","[{'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0205129', 'cui_str': 'Sagittal (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}]",69.0,0.0456393,"Mean (SD) recognition time (120 ± 48 vs. 179 ± 72 s, P = 0.0002) and injection time (54 ± 23 vs. 88 ± 36 s, P = 0.0001) were shorter in group A compared to group B. Median (IQR) procedure pain score was less in group A 2 (1-2) than in group B 2 (2-3);","[{'ForeName': 'Tarek F', 'Initials': 'TF', 'LastName': 'Tammam', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Suez Canal University Hospital, Ismailia, Egypt. tarek1367@hotmail.com.'}, {'ForeName': 'Ghada A', 'Initials': 'GA', 'LastName': 'Kamhawy', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Suez Canal University Hospital, Ismailia, Egypt.'}]",Journal of anesthesia,['10.1007/s00540-019-02674-w']
588,31053215,Randomized Controlled Trial of Imagery Rehearsal for Posttraumatic Nightmares in Combat Veterans.,"STUDY OBJECTIVES


To examine the efficacy of imagery rehearsal (IR) combined with cognitive behavioral therapy for insomnia (CBT-I) compared to CBT-I alone for treating recurrent nightmares in military veterans with posttraumatic stress disorder (PTSD).
METHODS


In this randomized controlled study, 108 male and female United States veterans of the Iraq and Afghanistan conflicts with current, severe PTSD and recurrent, deployment-related nightmares were randomized to six sessions of IR + CBT-I (n = 55) or CBT-I (n = 53). Primary outcomes were measured with the Nightmare Frequency Questionnaire (NFQ) and Nightmare Distress Questionnaire (NDQ).
RESULTS


Improvement with treatment was significant (29% with reduction in nightmare frequency and 22% with remission). Overall, IR + CBT-I was not superior to CBT-I (NFQ: -0.12; 95% confidence interval = -0.87 to 0.63; likelihood ratio chi square = 4.7(3),  P  = .2); NDQ: 1.5, 95% confidence interval = -1.4 to 4.4; likelihood ratio chi square = 7.3,  P  = .06).
CONCLUSIONS


Combining IR with CBT-I conferred no advantage overall. Further research is essential to examine the possibly greater benefit of adding IR to CBT-I for some subgroups of veterans with PTSD.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Title: Cognitive Behavioral Therapy (CBT) for Nightmares in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans; Identifier: NCT00691626; URL: https://clinicaltrials.gov/ct2/show/NCT00691626.",2019,"Overall, IR + CBT-I was not superior to CBT-I (NFQ: -0.12; 95% confidence interval =","['108 male and female United States veterans of the Iraq and Afghanistan conflicts with current, severe PTSD and recurrent, deployment-related nightmares', 'Posttraumatic Nightmares in Combat Veterans', 'military veterans with posttraumatic stress disorder (PTSD']","['IR + CBT-I (n = 55) or CBT', 'imagery rehearsal (IR) combined with cognitive behavioral therapy', 'CBT-I alone', 'Imagery Rehearsal', 'Cognitive Behavioral Therapy (CBT']",['Nightmare Frequency Questionnaire (NFQ) and Nightmare Distress Questionnaire (NDQ'],"[{'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0022066', 'cui_str': 'Republic of Iraq'}, {'cui': 'C0001732', 'cui_str': 'Afghanistan'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0028084', 'cui_str': 'Nightmares'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}]","[{'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0028084', 'cui_str': 'Nightmares'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",108.0,0.0549086,"Overall, IR + CBT-I was not superior to CBT-I (NFQ: -0.12; 95% confidence interval =","[{'ForeName': 'Gerlinde C', 'Initials': 'GC', 'LastName': 'Harb', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Joan M', 'Initials': 'JM', 'LastName': 'Cook', 'Affiliation': 'Yale University and National Center for PTSD, New Haven, Connecticut.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Phelps', 'Affiliation': 'Phoenix Australia Centre for Posttraumatic Mental Health, Melbourne, Australia.'}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Gehrman', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Forbes', 'Affiliation': 'Phoenix Australia Centre for Posttraumatic Mental Health, Melbourne, Australia.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Localio', 'Affiliation': 'University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Harpaz-Rotem', 'Affiliation': 'Yale University and National Center for PTSD, New Haven, Connecticut.'}, {'ForeName': 'Ruben C', 'Initials': 'RC', 'LastName': 'Gur', 'Affiliation': 'University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Ross', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7770']
589,31271654,Feasibility of Delivering a Tailored Intervention for Advance Care Planning in Primary Care Practice.,"BACKGROUND/OBJECTIVES


To determine the feasibility of conducting a cluster randomized controlled trial providing individualized feedback reports to increase advance care planning (ACP) engagement in the primary care setting.
DESIGN


Pilot cluster randomized controlled trial.
SETTING


Two primary care practices selected for geographic colocation.
PARTICIPANTS


Adults aged 55 years and older.
INTERVENTION


Brief assessment of readiness to engage in (stage of change for) three ACP behaviors (healthcare agent assignment, communication with agent about quality vs quantity of life, and living will completion) generating an individualized feedback report, plus a stage-matched brochure.
MEASURES


Patient recruitment and retention, intervention delivery, baseline characteristics, and stage of change movement.
RESULTS


Recruitment rates differed by practice. Several baseline sociodemographic characteristics differed between the 38 intervention and 41 control participants, including employment status, education, and communication with healthcare agent. Feedback was successfully delivered to all intervention participants, and over 90% of participants completed a 2-month follow-up. More intervention participants demonstrated progression in readiness than did control participants, without testing for statistical significance.
CONCLUSIONS


This pilot demonstrates opportunities and challenges of performing a clustered randomized controlled trial in primary care practices. Differences in the two practice populations highlight the challenges of matching sites. There was a signal for behavior change in the intervention group. J Am Geriatr Soc 67:1917-1921, 2019.",2019,"Feedback was successfully delivered to all intervention participants, and over 90% of participants completed a 2-month follow-up.","['Two primary care practices selected for geographic colocation', 'Adults aged\u200955 years and older']","['Delivering a Tailored Intervention', 'Brief assessment of readiness to engage in (stage of change for) three ACP behaviors (healthcare agent assignment, communication with agent about quality vs quantity of life, and living will completion) generating an individualized feedback report, plus a stage-matched brochure']","['progression in readiness', 'employment status, education, and communication with healthcare agent', 'Patient recruitment and retention, intervention delivery, baseline characteristics, and stage of change movement']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0023914', 'cui_str': 'Living Wills'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0242271', 'cui_str': 'Employment status (observable entity)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0242800', 'cui_str': 'Patient Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",,0.130754,"Feedback was successfully delivered to all intervention participants, and over 90% of participants completed a 2-month follow-up.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Paiva', 'Affiliation': 'Cancer Prevention Research Center, College of Health Sciences, University of Rhode Island, Kingston, Rhode Island.'}, {'ForeName': 'Colleen A', 'Initials': 'CA', 'LastName': 'Redding', 'Affiliation': 'Cancer Prevention Research Center, College of Health Sciences, University of Rhode Island, Kingston, Rhode Island.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Iannone', 'Affiliation': 'Program on Aging, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Zenoni', 'Affiliation': 'Clinical Epidemiology Research Center, Veterans Affairs (VA) Connecticut Healthcare System, West Haven, Connecticut.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': ""O'Leary"", 'Affiliation': 'Program on Aging, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Terri R', 'Initials': 'TR', 'LastName': 'Fried', 'Affiliation': 'Department of Medicine, Yale School of Medicine, New Haven, Connecticut.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16035']
590,32211883,Five-year follow-up of patients enrolled in the NEAT 001/ANRS 143 randomized clinical trial: NEAT 001/ANRS 143 LONG TERM study.,"BACKGROUND


Few long-term data are available in subjects having initiated ART with an NRTI-sparing regimen.
OBJECTIVES


Outcomes of subjects enrolled in the NEAT 001/ANRS 143 randomized clinical trial (comparing ritonavir-boosted darunavir + raltegravir versus ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine) were retrospectively collected, through anonymized electronic case report forms, up to 6 years post-enrolment.
METHODS


The last NEAT 001 visit (Week 96) was conducted in 745/805 randomized subjects (363/401 ritonavir-boosted darunavir + raltegravir and 382/404 ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine). Of these, 430 were enrolled in NEAT 001/ANRS 143 LONG TERM (NLT) study (201 raltegravir, 229 tenofovir disoproxil fumarate/emtricitabine), with a median follow-up of 44.4 months.
RESULTS


During NLT follow-up, the proportion of AIDS, non-AIDS events, virological rebound and serious adverse events, discontinuation for virological failure and for adverse events did not differ between groups; discontinuations for virological failure since NEAT 001 inclusion were more frequent in subjects with baseline CD4 <200 cells/mm3 (11.9% versus 5.3%; P = 0.077). At last follow-up, a quarter of subjects (22.2% for ritonavir-boosted darunavir + raltegravir and 29.7% for ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine) were still receiving their initial regimen. Integrase inhibitor exposure was not associated with weight gain (P = 0.48), while tenofovir disoproxil fumarate exposure was associated with a trend to higher creatinine increase (P = 0.067).
CONCLUSIONS


After a median of 5.6 years, subjects initiating ritonavir-boosted darunavir + raltegravir or ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine experienced few serious clinical adverse events. Most discontinuations were for reasons unrelated to adverse events or virological failure.",2020,"Integrase inhibitor exposure was not associated with weight gain (P = 0.48), while tenofovir disoproxil fumarate exposure was associated with a trend to higher creatinine increase (P = 0.067).
","['430 were enrolled in NEAT 001/ANRS', 'subjects having initiated ART with an NRTI-sparing regimen', 'subjects enrolled in the NEAT 001/ANRS 143 randomized clinical trial (comparing']","['ritonavir-boosted darunavir + raltegravir', 'tenofovir disoproxil fumarate', 'ritonavir-boosted darunavir + raltegravir and 382/404 ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine', 'tenofovir disoproxil fumarate/emtricitabine', 'ritonavir-boosted darunavir + raltegravir versus ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine', 'ritonavir-boosted darunavir + raltegravir or ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine', 'ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine']","['proportion of AIDS, non-AIDS events, virological rebound and serious adverse events, discontinuation for virological failure and for adverse events', 'weight gain']","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",430.0,0.107685,"Integrase inhibitor exposure was not associated with weight gain (P = 0.48), while tenofovir disoproxil fumarate exposure was associated with a trend to higher creatinine increase (P = 0.067).
","[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Raffi', 'Affiliation': ""INSERM CIC 1413 Nantes University, and Service des Maladies Infectieuses, Centre hospitalier universitaire de l'Hôtel-Dieu, Nantes, France.""}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Gaultier', 'Affiliation': 'CHU de Nantes, Direction de la Recherche, Nantes, France.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Pozniak', 'Affiliation': 'Chelsea and Westminster Hospital NHS Foundation Trust and LSHTM, London, UK.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Department of Infectious Diseases, Saint-Louis hospital, 1 avenue C. Vellefaux, Paris, and Assistance Publique Hopitaux de Paris and University of Paris Diderot, Sorbonne Paris Cité, France.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Jessen', 'Affiliation': 'Gemeinschaftspraxis Jessen-Stein, Berlin, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Antinori', 'Affiliation': 'Viral Immunodeficiencies Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy.'}, {'ForeName': 'Albane', 'Initials': 'A', 'LastName': 'Soria', 'Affiliation': ""INSERM CIC 1413 Nantes University, and Service des Maladies Infectieuses, Centre hospitalier universitaire de l'Hôtel-Dieu, Nantes, France.""}, {'ForeName': 'Morane', 'Initials': 'M', 'LastName': 'Cavellec', 'Affiliation': ""INSERM CIC 1413 Nantes University, and Service des Maladies Infectieuses, Centre hospitalier universitaire de l'Hôtel-Dieu, Nantes, France.""}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Le Thuaut', 'Affiliation': 'CHU de Nantes, Direction de la Recherche, Nantes, France.'}, {'ForeName': 'Maelle', 'Initials': 'M', 'LastName': 'Ningre', 'Affiliation': 'CHU de Nantes, Direction de la Recherche, Nantes, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'de Wit', 'Affiliation': 'Division of Infectious Diseases, Saint Pierre University Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa056']
591,31154298,"Electronic Alerts for Acute Kidney Injury Amelioration (ELAIA-1): a completely electronic, multicentre, randomised controlled trial: design and rationale.","INTRODUCTION


Acute kidney injury (AKI) is common among hospitalised patients and under-recognised by providers and yet carries a significant risk of morbidity and mortality. Electronic alerts for AKI have become more common despite a lack of strong evidence of their benefits. We designed a multicentre, randomised, controlled trial to evaluate the effectiveness of AKI alerts. Our aim is to highlight several challenges faced in the design of this trial, which uses electronic screening, enrolment, randomisation, intervention and data collection.
METHODS AND ANALYSIS


The design and implementation of an electronic alert system for AKI was a reiterative process involving several challenges and limitations set by the confines of the electronic medical record system. The trial will electronically identify and randomise 6030 adults with AKI at six hospitals over a 1.5-2 year period to usual care versus an electronic alert containing an AKI-specific order set. Our primary outcome will be a composite of AKI progression, inpatient dialysis and inpatient death within 14 days of randomisation. During a 1-month pilot in the medical intensive care unit of Yale New Haven Hospital, we have demonstrated feasibility of automating enrolment and data collection. Feedback from providers exposed to the alerts was used to continually improve alert clarity, user friendliness and alert specificity through refined inclusion and exclusion criteria.
ETHICS AND DISSEMINATION


This study has been approved by the appropriate ethics committees for each of our study sites. Our study qualified for a waiver of informed consent as it presents no more than minimal risk and cannot be feasibly conducted in the absence of a waiver. We are committed to open dissemination of our data through clinicaltrials.gov and submission of results to the NIH data sharing repository. Results of our trial will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


NCT02753751; Pre-results.",2019,"Feedback from providers exposed to the alerts was used to continually improve alert clarity, user friendliness and alert specificity through refined inclusion and exclusion criteria.
","['Acute Kidney Injury Amelioration (ELAIA-1', 'medical intensive care unit of Yale New Haven Hospital', '6030 adults with AKI at six hospitals over a 1.5-2\u2009year period to']",['usual care versus an electronic alert containing an AKI-specific order set'],"['composite of AKI progression, inpatient dialysis and inpatient death']","[{'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C2711734', 'cui_str': 'Medical intensive care unit'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0036849', 'cui_str': 'Set'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",6030.0,0.348347,"Feedback from providers exposed to the alerts was used to continually improve alert clarity, user friendliness and alert specificity through refined inclusion and exclusion criteria.
","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Mutter', 'Affiliation': 'Program of Applied Translational Research, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Program of Applied Translational Research, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Program of Applied Translational Research, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Biswas', 'Affiliation': 'Program of Applied Translational Research, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Boian', 'Initials': 'B', 'LastName': 'Etropolski', 'Affiliation': 'Program of Applied Translational Research, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Feldman', 'Affiliation': 'Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Garg', 'Affiliation': 'Department of Medcine, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Gourlie', 'Affiliation': 'Baim Institute for Clinical Research, Boston, Massachusetts, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Latham', 'Affiliation': 'Program of Applied Translational Research, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Haiqun', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Program of Applied Translational Research, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Palevsky', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Chirag', 'Initials': 'C', 'LastName': 'Parikh', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Moreira', 'Affiliation': 'Program of Applied Translational Research, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Ugochukwu', 'Initials': 'U', 'LastName': 'Ugwuowo', 'Affiliation': 'Program of Applied Translational Research, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Francis P', 'Initials': 'FP', 'LastName': 'Wilson', 'Affiliation': 'Program of Applied Translational Research, Yale University School of Medicine, New Haven, Connecticut, USA.'}]",BMJ open,['10.1136/bmjopen-2018-025117']
592,31331296,Polyhydramnios among women in a cluster-randomized trial of ultrasound during prenatal care within five low and low-middle income countries: a secondary analysis of the first look study.,"BACKGROUND


In many low and low-middle income countries, the incidence of polyhydramnios is unknown, in part because ultrasound technology is not routinely used. Our objective was to report the incidence of polyhydramnios in five low and low-middle income countries, to determine maternal characteristics associated with polyhydramnios, and report pregnancy and neonatal outcomes.
METHODS


We performed a secondary analysis of the First Look Study, a multi-national, cluster-randomized trial of ultrasound during prenatal care. We evaluated all women enrolled from Guatemala, Pakistan, Zambia, Kenya and the Democratic Republic of Congo (DRC) who received an examination by prenatal ultrasound. We used pairwise site comparisons with Tukey-Kramer adjustment and multivariable logistic models with general estimating equations to control for cluster-level effects. The diagnosis of polyhydramnios was confrimed by an U.S. based radiologist in a majority of cases (62%).
RESULTS


We identified 305/18,640 (1.6%) cases of polyhydramnios. 229 (75%) cases were from the DRC, with an incidence of 10%. A higher percentage of women with polyhydramnios experienced obstructed labor (7% vs 4%) and fetal malposition (4% vs 2%). Neonatal death was more common when polyhydramnios was present (OR 2.43; CI 1.15, 5.13).
CONCLUSIONS


Polyhydramnios occured in these low and low-middle income countries at a rate similar to high-income contries except in the DRC where the incidence was 10%. Polyhydramnios was associated with obstructed labor, fetal malposition, and neonatal death.
TRIAL REGISTRATION


NCT01990625 , November 21, 2013.",2019,"Neonatal death was more common when polyhydramnios was present (OR 2.43; CI 1.15, 5.13).
","['women enrolled from Guatemala, Pakistan, Zambia, Kenya and the Democratic Republic of Congo (DRC) who received an examination by prenatal ultrasound', 'women in a cluster-randomized trial of ultrasound during prenatal care within five low and low-middle income countries']",[],"['fetal malposition', 'Neonatal death', 'obstructed labor', 'obstructed labor, fetal malposition, and neonatal death']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0043444', 'cui_str': 'Belgian Congo'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]",[],"[{'cui': 'C0269699', 'cui_str': 'Finding of malposition of fetus'}, {'cui': 'C0410916', 'cui_str': 'Neonatal Death'}, {'cui': 'C0549186', 'cui_str': 'Obstructed (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0152156', 'cui_str': 'Obstructed labor (finding)'}]",,0.127671,"Neonatal death was more common when polyhydramnios was present (OR 2.43; CI 1.15, 5.13).
","[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Bauserman', 'Affiliation': 'Department of Pediatrics, University of North Carolina School of Medicine, 101 Manning Drive, CB 7596, Chapel Hill, NC, 27599-7596, USA. Melissa_bauserman@med.unc.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Nathan', 'Affiliation': 'Department of Radiology, Harborview Medical Center, University of Washington Medical Center, Seattle, WA, USA.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Lokangaka', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa, DRC, Republic of the Congo.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'McClure', 'Affiliation': 'RTI International, Durham, NC, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'RTI International, Durham, NC, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ishoso', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa, DRC, Republic of the Congo.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Tshefu', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa, DRC, Republic of the Congo.'}, {'ForeName': 'Lester', 'Initials': 'L', 'LastName': 'Figueroa', 'Affiliation': 'Fundación para la Alimentación y Nutrición de Centro América y Panamá (FANCAP), Guatemala City, Guatemala.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Garces', 'Affiliation': 'Fundación para la Alimentación y Nutrición de Centro América y Panamá (FANCAP), Guatemala City, Guatemala.'}, {'ForeName': 'Margo S', 'Initials': 'MS', 'LastName': 'Harrison', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Wallace', 'Affiliation': 'RTI International, Durham, NC, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Saleem', 'Affiliation': 'Department of Community Health Sciences, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Waseem', 'Initials': 'W', 'LastName': 'Mirza', 'Affiliation': 'Department of Pediatric Radiology, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Krebs', 'Affiliation': 'Department of Pediatrics, University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hambidge', 'Affiliation': 'Department of Pediatrics, University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Waldemar', 'Initials': 'W', 'LastName': 'Carlo', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Elwyn', 'Initials': 'E', 'LastName': 'Chomba', 'Affiliation': 'Department of Pediatrics, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Menachem', 'Initials': 'M', 'LastName': 'Miodovnik', 'Affiliation': 'Perinatology and Pregnancy Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, MD, USA.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Koso-Thomas', 'Affiliation': 'Perinatology and Pregnancy Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, MD, USA.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Liechty', 'Affiliation': 'Department of Pediatrics, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Esamai', 'Affiliation': 'School of Medicine, Moi University, Eldoret, Kenya.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Swanson', 'Affiliation': ""Department of Radiology, Seattle Children's Hospital, University of Washington Medical Center, Seattle, WA, USA.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Swanson', 'Affiliation': 'Department of Radiology, University of Washington Medical Center, Seattle, WA, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Goldenberg', 'Affiliation': 'Department of Obstetrics/Gynecology, Columbia University, New York City, NY, USA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Bose', 'Affiliation': 'Department of Pediatrics, University of North Carolina School of Medicine, 101 Manning Drive, CB 7596, Chapel Hill, NC, 27599-7596, USA.'}]",BMC pregnancy and childbirth,['10.1186/s12884-019-2412-6']
593,32210365,Clinical activity of a htert (vx-001) cancer vaccine as post-chemotherapy maintenance immunotherapy in patients with stage IV non-small cell lung cancer: final results of a randomised phase 2 clinical trial.,"BACKGROUND


The cancer vaccine Vx-001, which targets the universal tumour antigen TElomerase Reverse Transcriptase (TERT), can mount specific Vx-001/TERT 572  CD8 + cytotoxic T cells; this immune response is associated with improved overall survival (OS) in patients with advanced/metastatic non-small cell lung cancer (NSCLC).
METHODS


A randomised, double blind, phase 2b trial, in HLA-A*201-positive patients with metastatic, TERT-expressing NSCLC, who did not progress after first-line platinum-based chemotherapy were randomised to receive either Vx-001 or placebo. The primary endpoint of the trial was OS.
RESULTS


Two hundred and twenty-one patients were randomised and 190 (101 and 89 patients in the placebo and the Vx-001 arm, respectively) were analysed for efficacy. There was not treatment-related toxicity >grade 2. The study did not meet its primary endpoint (median OS 11.3 and 14.3 months for the placebo and the Vx-001, respectively; p = 0.86) whereas the median Time to Treatment Failure (TTF) was 3.5 and 3.6 months, respectively. Disease control for >6months was observed in 30 (33.7%) and 26 (25.7%) patients treated with Vx-001 and placebo, respectively. There was no documented objective CR or PR. Long lasting TERT-specific immune response was observed in 29.2% of vaccinated patients who experienced a significantly longer OS compared to non-responders (21.3 and 13.4 months, respectively; p = 0.004).
CONCLUSION


Vx-001 could induce specific CD8 +  immune response but failed to meet its primary endpoint. Subsequent studies have to be focused on the identification and treatment of subgroups of patients able to mount an effective immunological response to Vx-001.
CLINICAL TRIAL REGISTRATION


NCT01935154.",2020,"Long lasting TERT-specific immune response was observed in 29.2% of vaccinated patients who experienced a significantly longer OS compared to non-responders (21.3 and 13.4 months, respectively; p = 0.004).
","['patients with advanced/metastatic non-small cell lung cancer (NSCLC', 'patients with stage IV non-small cell lung cancer', 'Two hundred and twenty-one patients were randomised and 190 (101 and 89 patients in the', 'A*201-positive patients with metastatic, TERT-expressing NSCLC, who did not progress after first-line platinum-based chemotherapy']","['htert (vx-001) cancer vaccine', 'HLA', 'placebo', 'Vx-001 or placebo', 'chemotherapy maintenance immunotherapy']","['objective CR or PR', 'overall survival (OS', 'median Time to Treatment Failure (TTF', 'specific CD8 +  immune response', 'Long lasting TERT-specific immune response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer (disorder)'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C1958472', 'cui_str': 'Vx001 cpd'}, {'cui': 'C0376659', 'cui_str': 'Vaccines, Tumor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3494202', 'cui_str': 'Time-to-Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",221.0,0.621622,"Long lasting TERT-specific immune response was observed in 29.2% of vaccinated patients who experienced a significantly longer OS compared to non-responders (21.3 and 13.4 months, respectively; p = 0.004).
","[{'ForeName': 'Cesare', 'Initials': 'C', 'LastName': 'Gridelli', 'Affiliation': 'S.G. Moscati Hospital, Avellino, Italy. cgridelli@libero.it.'}, {'ForeName': 'Tudor', 'Initials': 'T', 'LastName': 'Ciuleanu', 'Affiliation': 'Institutui, Oncologic I. Chircuta, Cluz-Napoca, Romania.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Domine', 'Affiliation': 'Fundacion Jimenez Diaz, Madrid, Spain.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Szczesna', 'Affiliation': 'Mazowieckie Centrum, Otwock, Poland.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Bover', 'Affiliation': 'Son Llatzer Hospital, Palma de Mallorca, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Cobo', 'Affiliation': 'Hospital Regional Universitario Málaga, Instituto de Investigaciones Biomédicas (IBIMA), Málaga, Spain.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Kentepozidis', 'Affiliation': '251 General Airforce Hospital, Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Zarogoulidis', 'Affiliation': 'Papanikolaou General Hospital, Exohi, Greece.'}, {'ForeName': 'Charalabos', 'Initials': 'C', 'LastName': 'Kalofonos', 'Affiliation': 'University Hospital of Patras, Rio, Greece.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Kazarnowisz', 'Affiliation': 'Oddzial Onkologiiz Pododdziatem, Olsztyn, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Korozan', 'Affiliation': 'Hospicjum Dutkiewicza SAC, Gdansk, Poland.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'de Las Penas', 'Affiliation': 'Hospital Provincial de Castellon, Castellon, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Majem', 'Affiliation': 'Hospital de la Santa Creui Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Chella', 'Affiliation': 'A.O.U. di Pisa Hospital, Pisa, Italy.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Griesinger', 'Affiliation': 'Pius Hospital, Oldenburg, Germany.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Bournakis', 'Affiliation': 'University Hospital ""Aretaieion"", Athens, Greece.'}, {'ForeName': 'Parvis', 'Initials': 'P', 'LastName': 'Sadjadian', 'Affiliation': 'Johannes Wesling Klinikum, Minden, Germany.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Kotsakis', 'Affiliation': 'Dpt of Medical Oncology, University General Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Chinet', 'Affiliation': 'Hopital Ambroise Paré, Boulogne-Billancourt, France.'}, {'ForeName': 'Kostantinos N', 'Initials': 'KN', 'LastName': 'Syrigos', 'Affiliation': 'General Hospital of Thoracic Diseases \'\'Sotiria"", Athens, Greece.'}, {'ForeName': 'Pierpaolo', 'Initials': 'P', 'LastName': 'Correale', 'Affiliation': 'University Hospital of Siena, Siena, Italy.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Gallou', 'Affiliation': 'Vaxon-Biotech, Paris, France.'}, {'ForeName': 'Jeanne- Menez', 'Initials': 'JM', 'LastName': 'Jamet', 'Affiliation': 'Vaxon-Biotech, Paris, France.'}, {'ForeName': 'Eleni- Kyriaki', 'Initials': 'EK', 'LastName': 'Vetsika', 'Affiliation': 'University General Hospital of Heraklion, Heraklion, Crete, Greece.'}, {'ForeName': 'Kostas', 'Initials': 'K', 'LastName': 'Kosmatopoulos', 'Affiliation': 'Vaxon-Biotech, Paris, France.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Georgoulias', 'Affiliation': 'University General Hospital of Heraklion, Heraklion, Crete, Greece.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of cancer,['10.1038/s41416-020-0785-y']
594,30470978,The Effects of the Nurse Navigation Program in Promoting Colorectal Cancer Screening Behaviors: a Randomized Controlled Trial.,"Although screening programs are known and recommended for the early detection of colorectal cancer (CRC), the screening rates for the fecal occult blood test (FOBT) and colonoscopy are very low among adult individuals. Navigation programs, also known as individualized counseling, have recently begun to be used for increasing screening rates. The purpose of this study was to compare the efficacy of the Nurse Navigation Program versus usual care on CRC screening participation and movement in stage of adoption for CRC screening and to examine perceived benefits of and barriers to CRC screening. This study was designed in line with a pre- and posttest two-group methodology. A total of 110 participants (55 nurse-navigated and 55 non-navigated patients) were studied. Data were collected using the following three tools: a sociodemographic information form, the Harvard Colorectal Cancer Risk Assessment Tool, and Instruments to Measure Colorectal Cancer Screening Benefits and Barriers. Following the Nurse Navigation Program, the FOBT (82 and 84%, respectively) and colonoscopy completion rates (15 and 22%, respectively) were significantly higher in the nurse-navigated group than in the non-navigated group at 3 and 6 months follow-up. Following the program, the benefit perceptions of the nurse-navigated group about CRC screening were improved, and their barrier perceptions were reduced. The results showed that the Nurse Navigation Program had significant effects on CRC screening behavior and health-related beliefs concerning CRC screening. Further assessment of the Nurse Navigation Program in different groups should be performed to observe its effects.",2020,The results showed that the Nurse Navigation Program had significant effects on CRC screening behavior and health-related beliefs concerning CRC screening.,"['Colorectal Cancer Screening Behaviors', '110 participants (55 nurse-navigated and 55 non-navigated patients']","['Nurse Navigation Program versus usual care', 'Nurse Navigation Program']","['colonoscopy completion rates', 'CRC screening behavior and health-related beliefs concerning CRC screening']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",110.0,0.0176525,The results showed that the Nurse Navigation Program had significant effects on CRC screening behavior and health-related beliefs concerning CRC screening.,"[{'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Temucin', 'Affiliation': 'Nursing Faculty, Oncology Nursing Department, University of Health Sciences, Istanbul, Turkey. temucinelif@gmail.com.'}, {'ForeName': 'Nursen O', 'Initials': 'NO', 'LastName': 'Nahcivan', 'Affiliation': 'Florence Nightingale Nursing Faculty, Public Health Nursing Department, Istanbul University, Istanbul, Turkey.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1448-z']
595,31206313,Simvastatin Improves Neutrophil Function and Clinical Outcomes in Pneumonia. A Pilot Randomized Controlled Clinical Trial.,"Rationale:  Population studies suggest improved sepsis outcomes with statins, but the results of randomized controlled trials in patients with sepsis and organ dysfunction in critical care settings have broadly been negative.  In vitro  data suggest that statins modulate age-related neutrophil functions, improving neutrophil responses to infection, but only in older patients and at high doses. Objectives:  To determine if high-dose simvastatin improves neutrophil functions and is safe and tolerated in hospitalized older adults with community-acquired pneumonia with sepsis (CAP + S) not admitted to critical care. Methods:  We conducted a randomized, double-blind, placebo-controlled pilot study of simvastatin 80 mg or placebo for 7 days for patients with CAP + S aged 55 years or older admitted to a secondary care hospital. The Day 4 primary endpoint was change in neutrophil extracellular trap formation (NETosis). Day 4 secondary endpoints included neutrophil chemotaxis, safety and tolerability, Sequential Organ Failure Assessment score, mortality, readmission, and markers of tissue degradation/inflammation. Measurements and Main Results:  Four days of simvastatin adjuvant therapy in patients with CAP + S was associated with improvements in systemic neutrophil function (NETosis and chemotaxis), a reduction in systemic neutrophil elastase burden, and improved Sequential Organ Failure Assessment scores compared with placebo. A  post hoc  analysis demonstrated that simvastatin therapy was associated with improved hospitalization-free survival compared with placebo. Simvastatin was well tolerated in this elderly and multimorbid patient group with common coprescription of macrolide antibiotics. Conclusions:  This pilot study supports high-dose simvastatin as an adjuvant therapy for CAP + S in an older and milder disease cohort than assessed previously. A definitive multicenter study is now warranted in this population to assess the likelihood of benefit and harm.Clinical trial registered with EudraCT (2012-00343-29).",2019,"Four days of simvastatin adjuvant therapy in CAP+S was associated with improvements in systemic neutrophil function (NETosis and chemotaxis), a reduction in systemic neutrophil elastase burden and improved SOFA scores compared with placebo.","['hospitalized older adults with community acquired pneumonia with sepsis (CAP+S) not admitted to critical care', 'Pneumonia', 'patients with sepsis and organ dysfunction in critical care settings', 'CAP+S patients aged >55 years admitted to a secondary care hospital']","['Simvastatin', 'simvastatin 80mg or placebo', 'placebo', 'simvastatin']","['hospital-free survival', 'tolerated', 'systemic neutrophil elastase burden and improved SOFA scores', 'neutrophil functions', 'neutrophil chemotaxis, safety and tolerability, Sequential Organ Failure Assessment(SOFA) score, mortality, readmission and markers of tissue degradation/inflammation', 'Neutrophil Function', 'systemic neutrophil function (NETosis and chemotaxis', 'change in neutrophil NETosis']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia (disorder)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0010337', 'cui_str': 'Critical Care'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337953', 'cui_str': 'Secondary care hospital (environment)'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C1607412', 'cui_str': 'Simvastatin 80 MG [Zocor]'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0064833', 'cui_str': 'Granulocyte Elastase'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0312861', 'cui_str': 'Neutrophil chemotaxis, function (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3494459', 'cui_str': 'SOFAS Scores'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0008018', 'cui_str': 'Chemotaxis'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.646419,"Four days of simvastatin adjuvant therapy in CAP+S was associated with improvements in systemic neutrophil function (NETosis and chemotaxis), a reduction in systemic neutrophil elastase burden and improved SOFA scores compared with placebo.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Sapey', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, Queen Elizabeth Hospital Birmingham, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Jaimin M', 'Initials': 'JM', 'LastName': 'Patel', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, Queen Elizabeth Hospital Birmingham, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Greenwood', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, Queen Elizabeth Hospital Birmingham, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Georgia M', 'Initials': 'GM', 'LastName': 'Walton', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, Queen Elizabeth Hospital Birmingham, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Grudzinska', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, Queen Elizabeth Hospital Birmingham, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Dhruv', 'Initials': 'D', 'LastName': 'Parekh', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, Queen Elizabeth Hospital Birmingham, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Rahul Y', 'Initials': 'RY', 'LastName': 'Mahida', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, Queen Elizabeth Hospital Birmingham, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Rachel C A', 'Initials': 'RCA', 'LastName': 'Dancer', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, Queen Elizabeth Hospital Birmingham, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Sebastian T', 'Initials': 'ST', 'LastName': 'Lugg', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, Queen Elizabeth Hospital Birmingham, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Howells', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, Queen Elizabeth Hospital Birmingham, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Hazeldine', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, Queen Elizabeth Hospital Birmingham, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Newby', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, Queen Elizabeth Hospital Birmingham, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Scott', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, Queen Elizabeth Hospital Birmingham, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nightingale', 'Affiliation': 'University Hospitals Birmingham National Health Service Foundation Trust, Birmingham, United Kingdom; and.'}, {'ForeName': 'Adam T', 'Initials': 'AT', 'LastName': 'Hill', 'Affiliation': 'Medical Research Council Centre for Inflammation Research, Department of Respiratory Medicine, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Thickett', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, Queen Elizabeth Hospital Birmingham, University of Birmingham, Birmingham, United Kingdom.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201812-2328OC']
596,32212354,Impact on Health-Related Quality of Life of Parenteral Nutrition for Patients with Advanced Cancer Cachexia: Results from a Randomized Controlled Trial.,"BACKGROUND


Malnutrition worsens health-related quality of life (HRQoL) and the prognosis of patients with advanced cancer. This study aimed to assess the clinical benefits of parenteral nutrition (PN) over oral feeding (OF) for patients with advanced cancer cachexia and without intestinal impairment.
MATERIAL AND METHODS


In this prospective multicentric randomized controlled study, patients with advanced cancer and malnutrition were randomly assigned to optimized nutritional care with or without supplemental PN. Zelen's method was used for randomization to facilitate inclusions. Nutritional and performance status and HRQoL using the European Organization for Research and Treatment of Cancer QLQ-C15-PAL questionnaire were evaluated at baseline and monthly until death. Primary endpoint was HRQoL deterioration-free survival (DFS) defined as a definitive deterioration of ≥10 points compared with baseline, or death.
RESULTS


Among the 148 randomized patients, 48 patients were in the experimental arm with PN, 63 patients were in the control arm with OF only, and 37 patients were not included because of early withdrawal or refused consent. In an intent to treat analysis, there was no difference in HRQoL DFS between the PN arm or OF arm for the three targeted dimensions: global health (hazard ratio [HR], 1.31; 95% confidence interval [CI], 0.88-1.94; p = .18), physical functioning (HR, 1.58; 95% CI, 1.06-2.35; p = .024), and fatigue (HR, 1.19; 95% CI, 0.80-1.77; p = .40); there was a negative trend for overall survival among patients in the PN arm. In as treated analysis, serious adverse events (mainly infectious) were more frequent in the PN arm than in the OF arm (p = .01).
CONCLUSION


PN improved neither HRQoL nor survival and induced more serious adverse events than OF among patients with advanced cancer and malnutrition. Clinical trial identification number. NCT02151214 IMPLICATIONS FOR PRACTICE: This clinical trial showed that parenteral nutrition improved neither quality of life nor survival and generated more serious adverse events than oral feeding only among patients with advanced cancer cachexia and no intestinal impairment. Parenteral nutrition should not be prescribed for patients with advanced cancer, cachexia, and no intestinal failure when life expectancy is shorter than 3 months. Further studies are needed to assess the useful period with a potential benefit of artificial nutrition for patients with advanced cancer.",2020,"In an intent to treat analysis, there was no difference in HRQoL DFS between the PN arm or OF arm for the three targeted dimensions: global health (hazard ratio [HR], 1.31; 95% confidence interval [CI], 0.88-1.94; p = .18), physical functioning (HR, 1.58; 95% CI, 1.06-2.35; p = .024), and fatigue (HR, 1.19; 95% CI, 0.80-1.77; p = .40); there was a negative trend for overall survival among patients in the PN arm.","['patients with advanced cancer and malnutrition', '148 randomized patients, 48 patients were in the experimental arm with PN, 63 patients were in the control arm with OF only, and 37 patients were not included because of early withdrawal or refused consent', 'patients with advanced cancer cachexia and no intestinal impairment', 'patients with advanced cancer', 'patients with advanced cancer cachexia and without intestinal impairment', 'Patients with Advanced Cancer Cachexia']","['Parenteral Nutrition', 'Parenteral nutrition', 'parenteral nutrition (PN) over oral feeding (OF', 'optimized nutritional care with or without supplemental PN', 'parenteral nutrition']","['physical functioning', 'overall survival', 'HRQoL nor survival', 'serious adverse events', 'HRQoL deterioration-free survival (DFS) defined as a definitive deterioration of ≥10 points compared with baseline, or death', 'HRQoL DFS', 'Cancer QLQ-C15-PAL questionnaire', 'quality of life nor survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]","[{'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034380'}]",148.0,0.277114,"In an intent to treat analysis, there was no difference in HRQoL DFS between the PN arm or OF arm for the three targeted dimensions: global health (hazard ratio [HR], 1.31; 95% confidence interval [CI], 0.88-1.94; p = .18), physical functioning (HR, 1.58; 95% CI, 1.06-2.35; p = .024), and fatigue (HR, 1.19; 95% CI, 0.80-1.77; p = .40); there was a negative trend for overall survival among patients in the PN arm.","[{'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Bouleuc', 'Affiliation': ""INSERM Centre d'Investigation Clinique (CIC) 1431, Centre Hospitalier Universitaire (CHU) Besançon, France.""}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Anota', 'Affiliation': 'Methodology and Quality of Life in Oncology Unit (INSERM Unité Mixte de Recherche [UMR] 1098), Centre Hospitalier Universitaire (CHU) Besançon, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Cornet', 'Affiliation': ""INSERM Centre d'Investigation Clinique (CIC) 1431, Centre Hospitalier Universitaire (CHU) Besançon, France.""}, {'ForeName': 'Ghislain', 'Initials': 'G', 'LastName': 'Grodard', 'Affiliation': ""INSERM Centre d'Investigation Clinique (CIC) 1431, Centre Hospitalier Universitaire (CHU) Besançon, France.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Thiery-Vuillemin', 'Affiliation': 'Medical Oncology Department, Centre Hospitalier Universitaire (CHU) Besançon, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Dubroeucq', 'Affiliation': 'Department of Supportive Care, Institut Jean Godinot, Reims, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Crétineau', 'Affiliation': 'Department of Supportive Care, Institut de cancérologie de Lorraine, Vandoeuvre-lès-Nancy, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Frasie', 'Affiliation': 'Department of Supportive Care, Centre Paul Strauss, Strasbourg, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Gamblin', 'Affiliation': 'Department of Supportive Care, Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Gisèle', 'Initials': 'G', 'LastName': 'Chvetzoff', 'Affiliation': 'Department of Supportive Care, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Favier', 'Affiliation': 'Medical Oncology Department, Centre Georges-François Leclerc, Dijon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Tournigand', 'Affiliation': 'Medical Oncology Department, Hôpital Henri Mondor, Assistance Publique-Hôpitaux de Paris (APHP), Créteil, France.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Grach', 'Affiliation': 'Department of Supportive Care, Centre François-Baclesse, Caen, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Raynard', 'Affiliation': 'Tranversal Unit of Nutrition, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Salas', 'Affiliation': 'Medical Oncology Department, Centre Hospitalier (CH) La Timone, Marseille, France.'}, {'ForeName': 'Géraldine', 'Initials': 'G', 'LastName': 'Capodano', 'Affiliation': 'Department of Supportive Care, Institut Paoli-Calmettes, Marseille, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Pazart', 'Affiliation': ""INSERM Centre d'Investigation Clinique (CIC) 1431, Centre Hospitalier Universitaire (CHU) Besançon, France.""}, {'ForeName': 'Régis', 'Initials': 'R', 'LastName': 'Aubry', 'Affiliation': ""INSERM Centre d'Investigation Clinique (CIC) 1431, Centre Hospitalier Universitaire (CHU) Besançon, France.""}]",The oncologist,['10.1634/theoncologist.2019-0856']
597,30386978,Communicating Actively Responding Empathically (CARE): Comparison of Communication Training Workshops for Health Professionals Working in Cancer Care.,"Accessing full-day communication skills training can be challenging for health professionals working in cancer care. This study aimed to examine the effectiveness of Communicating Actively, Responding Empathically (CARE Express), a modified 2-h communication skills training course, across measures of health professional confidence, skills and attitudes. Cancer care health professionals (n = 147) were recruited from allied health, nursing and medical disciplines, using a partial randomisation to allocate to three arms: control, two-hour training (CARE Express) and 1-day training (CARE). Perceived confidence and skills were measured by self-report using a purpose-built scale, and written responses to a challenging clinical encounter were obtained at baseline, post-training and three-months post-training. Attitudes toward psychosocial issues were evaluated with the Physician Belief Scale at baseline and 3 months post-training. No changes were observed in the control group (n = 50) from baseline to 3 months follow-up. Participants in the CARE Express (n = 48) and CARE (n = 49) groups had significant improvement in confidence in identifying/responding to emotions between baseline and 3 months post-training (p < 0.001), as well as their attitude toward psychosocial care (p < 0.001). A significant increase in ""acknowledging"" responses from baseline to 3 months was also observed for CARE Express and CARE (p < 0.001), with no difference between groups. CARE Express and CARE resulted in changes in confidence in emotional identification/response, psychosocial focus and communication skills maintained at 3 months post-training. Whilst the 1-day workshop has been regarded as gold standard, this study has revealed positive outcomes with a modified 2-h version, thus offering a potential alternate training model.",2020,"CARE Express and CARE resulted in changes in confidence in emotional identification/response, psychosocial focus and communication skills maintained at 3 months post-training.","['Participants in the CARE Express (n\u2009=\u200948) and CARE (n\u2009', 'Cancer care health professionals (n\u2009=\u2009147) were recruited from allied health, nursing and medical disciplines, using a partial randomisation to allocate to three arms', 'Health Professionals Working in Cancer Care']","['Communication Training Workshops', 'control, two-hour training (CARE Express) and 1-day training (CARE']","['acknowledging"" responses', 'attitude toward psychosocial care', 'Perceived confidence and skills', 'health professional confidence, skills and attitudes', 'Physician Belief Scale', 'confidence in identifying/responding to emotions', 'confidence in emotional identification/response, psychosocial focus and communication skills']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0043227', 'cui_str': 'Work'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C2958078', 'cui_str': 'Psychosocial care'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0222045'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}]",147.0,0.0210218,"CARE Express and CARE resulted in changes in confidence in emotional identification/response, psychosocial focus and communication skills maintained at 3 months post-training.","[{'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Nixon', 'Affiliation': 'Occupational Therapy Department, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, Brisbane, 4102, Australia. jodie.nixon@health.qld.gov.au.'}, {'ForeName': 'Lyndal', 'Initials': 'L', 'LastName': 'Gray', 'Affiliation': 'Occupational Therapy Department, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, Brisbane, 4102, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Turner', 'Affiliation': 'Faculty of Medicine, The University of Queensland, St Lucia, QLD, 4027, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bernard', 'Affiliation': 'QFAB Bioinformatics, Institute for Molecular Bioscience, The University of Queensland, St Lucia, QLD, 4027, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Scaife', 'Affiliation': 'Cancer Services, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, Brisbane, 4102, Australia.'}, {'ForeName': 'Bena', 'Initials': 'B', 'LastName': 'Cartmill', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, St Lucia, Australia.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1439-0']
598,29782696,Routine antenatal ultrasound in low- and middle-income countries: first look - a cluster randomised trial.,"OBJECTIVE


Ultrasound is widely regarded as an important adjunct to antenatal care (ANC) to guide practice and reduce perinatal mortality. We assessed the impact of ANC ultrasound use at health centres in resource-limited countries.
DESIGN


Cluster randomised trial.
SETTING


Clusters within five countries (Democratic Republic of Congo, Guatemala, Kenya, Pakistan, and Zambia) METHODS: Clusters were randomised to standard ANC or standard care plus two ultrasounds and referral for complications. The study trained providers in intervention clusters to perform basic obstetric ultrasounds.
MAIN OUTCOME MEASURES


The primary outcome was a composite of maternal mortality, maternal near-miss mortality, stillbirth, and neonatal mortality.
RESULTS


During the 24-month trial, 28 intervention and 28 control clusters had 24 263 and 23 160 births, respectively; 78% in the intervention clusters received at least one study ultrasound; 60% received two. The prevalence of conditions noted including twins, placenta previa, and abnormal lie was within expected ranges. 9% were referred for an ultrasound-diagnosed condition, and 71% attended the referral. The ANC (RR 1.0 95% CI 1.00, 1.01) and hospital delivery rates for complicated pregnancies (RR 1.03 95% CI 0.89, 1.20) did not differ between intervention and control clusters nor did the composite outcome (RR 1.09 95% CI 0.97, 1.23) or its individual components.
CONCLUSIONS


Despite availability of ultrasound at ANC in the intervention clusters, neither ANC nor hospital delivery for complicated pregnancies increased. The composite outcome and the individual components were not reduced.
TWEETABLE ABSTRACT


Antenatal care ultrasound did not improve a composite outcome that included maternal, fetal, and neonatal mortality.",2018,"The ANC (RR 1.0 95% CI 1.00, 1.01) and hospital delivery rates for complicated pregnancies (RR 1.03 95% CI 0.89, 1.20) did not differ between intervention and control clusters nor did the composite outcome (RR 1.09 95% CI 0.97, 1.23) or its individual components.
","['Clusters within five countries (Democratic Republic of Congo, Guatemala, Kenya, Pakistan, and Zambia']","['standard ANC or standard care plus two ultrasounds and referral for complications', 'Routine antenatal ultrasound']","['hospital delivery rates', 'prevalence of conditions noted including twins, placenta previa, and abnormal lie', 'composite of maternal mortality, maternal near-miss mortality, stillbirth, and neonatal mortality']","[{'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0043444', 'cui_str': 'Belgian Congo'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0032046', 'cui_str': 'Placenta Previa'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0024923', 'cui_str': 'Maternal Mortality'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}]",9.0,0.213579,"The ANC (RR 1.0 95% CI 1.00, 1.01) and hospital delivery rates for complicated pregnancies (RR 1.03 95% CI 0.89, 1.20) did not differ between intervention and control clusters nor did the composite outcome (RR 1.09 95% CI 0.97, 1.23) or its individual components.
","[{'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Goldenberg', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'R O', 'Initials': 'RO', 'LastName': 'Nathan', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Swanson', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Saleem', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Mirza', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Esamai', 'Affiliation': 'Moi University, Eldoret, Kenya.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Muyodi', 'Affiliation': 'Moi University, Eldoret, Kenya.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Garces', 'Affiliation': 'INCAP, Guatemala City, Guatemala.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Figueroa', 'Affiliation': 'INCAP, Guatemala City, Guatemala.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Chomba', 'Affiliation': 'University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Chiwala', 'Affiliation': 'University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mwenechanya', 'Affiliation': 'University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tshefu', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa, DRC.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lokangako', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa, DRC.'}, {'ForeName': 'V L', 'Initials': 'VL', 'LastName': 'Bolamba', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa, DRC.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Moore', 'Affiliation': 'RTI International, Durham, NC, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Franklin', 'Affiliation': 'RTI International, Durham, NC, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Swanson', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Liechty', 'Affiliation': 'Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Bose', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'N F', 'Initials': 'NF', 'LastName': 'Krebs', 'Affiliation': 'University of Colorado, Denver, CO, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Michael Hambidge', 'Affiliation': 'University of Colorado, Denver, CO, USA.'}, {'ForeName': 'W A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kanaiza', 'Affiliation': 'Moi University, Eldoret, Kenya.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Naqvi', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'I S', 'Initials': 'IS', 'LastName': 'Pineda', 'Affiliation': 'San Carlos University, Guatemala City, Guatemala.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'López-Gomez', 'Affiliation': 'NICHD, Bethesda, MD, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hamsumonde', 'Affiliation': 'University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Harrison', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Koso-Thomas', 'Affiliation': 'NICHD, Bethesda, MD, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Miodovnik', 'Affiliation': 'NICHD, Bethesda, MD, USA.'}, {'ForeName': 'D D', 'Initials': 'DD', 'LastName': 'Wallace', 'Affiliation': 'RTI International, Durham, NC, USA.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'McClure', 'Affiliation': 'RTI International, Durham, NC, USA.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.15287']
599,31209602,Determining changes in bone metabolism after bariatric surgery in postmenopausal women.,"BACKGROUND


Accelerated bone loss is a known complication after bariatric surgery. Bone mineral density has been shown to decrease significantly after Laparoscopic Roux-en-Y gastric bypass (RYGB). Laparoscopic sleeve gastrectomy (SG) effects on bone density are largely unknown. This should be considered for those with increased preoperative risk for bone loss, such as postmenopausal females.
METHODS


This prospective clinical trial included postmenopausal patients, with BMI ≥ 35 k/m 2 , being evaluated for either RYGB or SG. Patients with history of osteoporosis, estrogen hormone replacement therapy, active smoking, glucocorticoid use, or weight > 295 lb were excluded. Patients underwent DEXA scans preoperatively and 1 year postoperatively with measurement of total body bone mineral density (BMD) and bone mineral content (BMC) as well as regional site-specific BMD and BMC.
RESULTS


A total of 28 patients were enrolled. 16 (57.1%) patients underwent RYGB and 12 (42.9%) patients underwent SG. Median preoperative BMI was 44.2 k/m 2  (IQR 39.9, 46.6). Median change in BMI at 12 months was - 11.3 k/m 2  (IQR - 12.8, - 7.9). A significant reduction in total body BMC was seen when comparing preoperative measurements to postoperative measurements (2358.32 vs 2280.68 grams; p = 0.002). Regional site BMC and BMD significantly decreased in the ribs and spine postoperatively (p = < 0.02) representing the greatest loss in the axial skeleton. Comparing those who underwent RYGB to SG there was no significant difference between the two groups when evaluating changes in total or regional site BMD.
CONCLUSION


Postmenopausal women were found to have decreased BMD and BMC after RYGB and SG, suggesting that high-risk women may benefit from postoperative DEXA screening. Further study is needed to determine the clinical significance of these findings. It is unknown if these changes in BMD are due to modifiable factors (Vitamin D level, activity level, hormone status, etc.), and whether BMD and BMC is recovered beyond 1 year.",2020,Regional site BMC and BMD significantly decreased in the ribs and spine postoperatively (p = < 0.02) representing the greatest loss in the axial skeleton.,"['postmenopausal women', '28 patients were enrolled', '295\xa0lb were excluded', 'postmenopausal patients, with BMI\u2009≥\u200935\xa0k/m 2 , being evaluated for either RYGB or SG', 'Patients with history of osteoporosis, estrogen hormone replacement therapy, active smoking, glucocorticoid use, or weight\u2009', 'Postmenopausal women']",['Laparoscopic sleeve gastrectomy (SG'],"['Median preoperative BMI', 'Median change in BMI', 'total or regional site BMD', 'total body BMC', 'Regional site BMC and BMD', 'total body bone mineral density (BMD) and bone mineral content (BMC', 'bone metabolism', 'BMD and BMC']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C3532614', 'cui_str': 'History of osteoporosis (situation)'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy (procedure)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",28.0,0.0387213,Regional site BMC and BMD significantly decreased in the ribs and spine postoperatively (p = < 0.02) representing the greatest loss in the axial skeleton.,"[{'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Luhrs', 'Affiliation': 'Department of Surgery, Duke University Medical Center, 407 Crutchfield St, Durham, NC, 27704, USA.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Davalos', 'Affiliation': 'Department of Surgery, Duke University Medical Center, 407 Crutchfield St, Durham, NC, 27704, USA.'}, {'ForeName': 'Reginald', 'Initials': 'R', 'LastName': 'Lerebours', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yoo', 'Affiliation': 'Department of Surgery, Duke University Medical Center, 407 Crutchfield St, Durham, NC, 27704, USA.'}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Tripler Army Medical Center, Honolulu, HI, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Tabone', 'Affiliation': 'Department of Surgery, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Omotosho', 'Affiliation': 'Department of Surgery, Rush University, Chicago, IL, USA.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Torquati', 'Affiliation': 'Department of Surgery, Rush University, Chicago, IL, USA.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Portenier', 'Affiliation': 'Department of Surgery, Duke University Medical Center, 407 Crutchfield St, Durham, NC, 27704, USA.'}, {'ForeName': 'Alfredo D', 'Initials': 'AD', 'LastName': 'Guerron', 'Affiliation': 'Department of Surgery, Duke University Medical Center, 407 Crutchfield St, Durham, NC, 27704, USA. alfredo.guerron-cruz@duke.edu.'}]",Surgical endoscopy,['10.1007/s00464-019-06922-8']
600,32209619,Negative pressure wound therapy compared with standard moist wound care on diabetic foot ulcers in real-life clinical practice: results of the German DiaFu-RCT.,"OBJECTIVES


The aim of the DiaFu study was to evaluate effectiveness and safety of negative pressure wound therapy (NPWT) in patients with diabetic foot wounds in clinical practice.
DESIGN


In this controlled clinical superiority trial with blinded outcome assessment patients were randomised in a 1:1 ratio stratified by study site and ulcer severity grade using a web-based-tool.
SETTING


This German national study was conducted in 40 surgical and internal medicine inpatient and outpatient facilities specialised in diabetes foot care.
PARTICIPANTS


368 patients were randomised and 345 participants were included in the modified intention-to-treat (ITT) population. Adult patients suffering from a diabetic foot ulcer at least for 4 weeks and without contraindication for NPWT were allowed to be included.
INTERVENTIONS


NPWT was compared with standard moist wound care (SMWC) according to local standards and guidelines.
PRIMARY AND SECONDARY OUTCOME MEASURES


Primary outcome was wound closure within 16 weeks. Secondary outcomes were wound-related and treatment-related adverse events (AEs), amputations, time until optimal wound bed preparation, wound size and wound tissue composition, pain and quality of life (QoL) within 16 weeks, and recurrences and wound closure within 6 months.
RESULTS


In the ITT population, neither the wound closure rate (difference: n=4 (2.5% (95% CI-4.7% - 9.7%); p=0.53)) nor the time to wound closure (p=0.244) was significantly different between the treatment arms. 191 participants (NPWT 127; SMWC 64) had missing endpoint documentations, premature therapy ends or unauthorised treatment changes. 96 participants in the NPWT arm and 72 participants in the SMWC arm had at least one AE (p=0.007), but only 16 AEs were related to NPWT.
CONCLUSIONS


NPWT was not superior to SMWC in diabetic foot wounds in German clinical practice. Overall, wound closure rate was low. Documentation deficits and deviations from treatment guidelines negatively impacted the outcome wound closure.
TRIAL REGISTRATION NUMBERS


NCT01480362 and DRKS00003347.",2020,"191 participants (NPWT 127; SMWC 64) had missing endpoint documentations, premature therapy ends or unauthorised treatment changes.","['191 participants (NPWT 127; SMWC 64) had missing endpoint documentations, premature therapy ends or unauthorised treatment changes', 'Adult patients suffering from a diabetic foot ulcer at least for 4 weeks and without contraindication for NPWT were allowed to be included', '40 surgical and internal medicine inpatient and outpatient facilities specialised in diabetes foot care', '96 participants in the NPWT arm and 72 participants in the', 'patients with diabetic foot wounds in clinical practice', '368 patients were randomised and 345 participants were included in the modified intention-to-treat (ITT) population']","['standard moist wound care', 'Negative pressure wound therapy', 'NPWT', 'SMWC', 'negative pressure wound therapy (NPWT', 'NPWT was compared with standard moist wound care (SMWC']","['wound closure rate', 'wound closure within 16 weeks', 'Overall, wound closure rate', 'wound-related and treatment-related adverse events (AEs), amputations, time until optimal wound bed preparation, wound size and wound tissue composition, pain and quality of life (QoL) within 16 weeks, and recurrences and wound closure within 6 months', 'diabetic foot ulcers', 'time to wound closure']","[{'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C2919691', 'cui_str': 'Treatment changed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1301624', 'cui_str': 'Contraindications'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1704211', 'cui_str': 'Specialized'}, {'cui': 'C0150240', 'cui_str': 'Foot care'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0206172', 'cui_str': 'Diabetic Foot'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}, {'cui': 'C0886052', 'cui_str': 'Administers care to wound sites'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}]","[{'cui': 'C0450015', 'cui_str': 'Method of wound closure (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034380'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}]",368.0,0.180456,"191 participants (NPWT 127; SMWC 64) had missing endpoint documentations, premature therapy ends or unauthorised treatment changes.","[{'ForeName': 'Dörthe', 'Initials': 'D', 'LastName': 'Seidel', 'Affiliation': 'Institut für Forschung in der Operativen Medizin (IFOM), Universität Witten/Herdecke, Köln, Germany Doerthe.Seidel@uni-wh.de.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Storck', 'Affiliation': 'Klinik für Gefäß- und Thoraxchirurgie, Städtisches Klinikum Karlsruhe gGmbH, Karlsruhe, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Lawall', 'Affiliation': 'Praxis für Herzkreislauferkrankungen, Ettlingen, Germany.'}, {'ForeName': 'Gernold', 'Initials': 'G', 'LastName': 'Wozniak', 'Affiliation': 'Gefäßchirurgische Klinik, Knappschaftskrankenhaus Bottrop GmbH, Bottrop, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mauckner', 'Affiliation': 'Innere Medizin, St. Remigius Krankenhaus Opladen, Leverkusen, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Hochlenert', 'Affiliation': 'Gemeinschaftspraxis Schlotmann-Hochlenert-Zavaleta-Haberstock, Köln, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Wetzel-Roth', 'Affiliation': 'Chirurgische Praxis Wetzel-Roth, Buchloe, Germany.'}, {'ForeName': 'Klemens', 'Initials': 'K', 'LastName': 'Sondern', 'Affiliation': 'Klinik für Innere Medizin/Diabetologie, Marien Hospital Dortmund-Hombruch, Dortmund, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hahn', 'Affiliation': 'Allgemein- und Viszeralchirurgie, Helfenstein Klinik, Geisslingen, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Rothenaicher', 'Affiliation': 'Chirurgische Praxis Rothenaicher, München, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Krönert', 'Affiliation': 'Klinik für Gefäßchirurgie, Thüringen-Kliniken ""Georgius Agricola"" GmbH, Saalfeld, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Zink', 'Affiliation': 'Diabetes Klinik, Diabetes Zentrum Mergentheim, Bad Mergentheim, Germany.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Neugebauer', 'Affiliation': 'Department fur Humanmedizin, Universität Witten/Herdecke, Witten, Germany.'}]",BMJ open,['10.1136/bmjopen-2018-026345']
601,32209621,Effectiveness of a guided online mindfulness-focused intervention in a student population: Study protocol for a randomised control trial.,"BACKGROUND


Previous studies show that university students experience higher psychological stress than the general population, resulting in increased vulnerability for mental disorders for the student population. Online mindfulness interventions will be delivered to students as a potentially promising and more flexible approach compared to face-to-face interventions with the aim of improving their mental health. This study purposes to investigate the effectiveness of a guided online mindfulness-focused intervention for university students by using both self-reported and psychobiological measures.
METHODS AND ANALYSES


In this multicentre, two-armed randomised controlled trial with a parallel design, a guided version of the online mindfulness-focused intervention 'StudiCare Mindfulness' will be compared with a waitlist control group. In total, 120 participants will be recruited at different universities (of Applied Sciences) in (Neu-) Ulm. Data will be assessed prior to randomisation, after eight weeks (post-intervention) and six months after randomisation (follow-up). The primary outcome measure is mindfulness. The secondary outcome measures include depression, anxiety and stress levels, well-being, interoceptive sensibility, emotion regulation and alexithymia. Psychobiological parameters comprise interoceptive accuracy, hair cortisol and FKBP5 genotype. Sociodemographic variables, treatment expectations, side and adverse side effects, as well as intervention satisfaction and adherence will be assessed. All data analyses will be conducted according to the intention-to-treat principle.
ETHICS AND DISSEMINATION


All study procedures have been approved by the Ethics Committee of Ulm University (application No. 48/18). The findings will be disseminated widely through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER


DRKS00014701.",2020,"The secondary outcome measures include depression, anxiety and stress levels, well-being, interoceptive sensibility, emotion regulation and alexithymia.","['120 participants will be recruited at different universities (of Applied Sciences) in (Neu-) Ulm', 'university students experience higher', 'university students']","['guided online mindfulness-focused intervention', ""guided version of the online mindfulness-focused intervention 'StudiCare Mindfulness""]","['depression, anxiety and stress levels, well-being, interoceptive sensibility, emotion regulation and alexithymia', 'Sociodemographic variables, treatment expectations, side and adverse side effects', 'psychological stress']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0002020', 'cui_str': 'Alexithymia'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0038443', 'cui_str': 'Stressor, Psychological'}]",120.0,0.13543,"The secondary outcome measures include depression, anxiety and stress levels, well-being, interoceptive sensibility, emotion regulation and alexithymia.","[{'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Schultchen', 'Affiliation': 'Department of Clinical & Health Psychology, Ulm University, Ulm, Baden-Württemberg, Germany dana.schultchen@uni-ulm.de.'}, {'ForeName': 'Ann-Marie', 'Initials': 'AM', 'LastName': 'Küchler', 'Affiliation': 'Department of Clinical Psychology & Psychotherapy, Ulm University, Ulm, Baden-Württemberg, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Schillings', 'Affiliation': 'Department of Clinical & Health Psychology, Ulm University, Ulm, Baden-Württemberg, Germany.'}, {'ForeName': 'Felicitas', 'Initials': 'F', 'LastName': 'Weineck', 'Affiliation': 'Department of Clinical & Health Psychology, Ulm University, Ulm, Baden-Württemberg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Karabatsiakis', 'Affiliation': 'Clinical Psychology, University of Innsbruck, Innsbruck, Tyrol, Austria.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Department of Clinical, Neuro- & Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Department of Clinical Psychology & Psychotherapy, Ulm University, Ulm, Baden-Württemberg, Germany.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Pollatos', 'Affiliation': 'Department of Clinical & Health Psychology, Ulm University, Ulm, Baden-Württemberg, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-032775']
602,32209625,"G-CSF (filgrastim) treatment for amyotrophic lateral sclerosis: protocol for a phase II randomised, double-blind, placebo-controlled, parallel group, multicentre clinical study (STEMALS-II trial).","INTRODUCTION


Amyotrophic lateral sclerosis (ALS) is a fatal progressive neurological disorder characterised by a selective degeneration of motor neurons (MNs). Stem cell transplantation is considered as a promising strategy in neurological disorders therapy and the possibility of inducing bone marrow cells (BMCs) to circulate in the peripheral blood is suggested to investigate stem cells migration in degenerated ALS nerve tissues where potentially repair MN damage. Granulocyte-colony stimulating factor (G-CSF) is a growth factor which stimulates haematopoietic progenitor cells, mobilises BMCs into injured brain and it is itself a neurotrophic factor for MN. G-CSF safety in humans has been demonstrated and many observations suggest that it may affect neural cells. Therefore, we decided to use G-CSF to mobilise BMCs into the peripheral circulation in patients with ALS, planning a clinical trial to evaluate the effect of G-CSF administration in ALS patients compared with placebo.
METHODS AND ANALYSIS


STEMALS-II is a phase II multicentre, randomised double-blind, placebo-controlled, parallel group clinical trial on G-CSF (filgrastim) and mannitol in ALS patients. Specifically, we investigate safety, tolerability and efficacy of four repeated courses of intravenous G-CSF and mannitol administered in 76 ALS patients in comparison with placebo (indistinguishable glucose solution 5%). We determine increase of G-CSF levels in serum and cerebrospinal fluid as CD34 +  cells and leucocyte count after treatment; reduction in ALS Functional Rating Scale-Revised Score, forced vital capacity, Scale for Testing Muscle Strength Score and quality of life; the adverse events/reactions during the treatment; changes in neuroinflammation biomarkers before and after treatment.
ETHICS AND DISSEMINATION


The study protocol was approved by the Ethics Committee of Azienda Ospedaliera Universitaria 'Città della Salute e della Scienza', Torino, Italy. Results will be presented during scientific symposia or published in scientific journals.
TRIAL REGISTRATION NUMBER


Eudract 2014-002228-28.",2020,"We determine increase of G-CSF levels in serum and cerebrospinal fluid as CD34 +  cells and leucocyte count after treatment; reduction in ALS Functional Rating Scale-Revised Score, forced vital capacity, Scale for Testing Muscle Strength Score and quality of life; the adverse events/reactions during the treatment; changes in neuroinflammation biomarkers before and after treatment.
","['76 ALS patients in comparison with placebo (indistinguishable glucose solution 5', 'ALS patients', 'amyotrophic lateral sclerosis']","['G-CSF (filgrastim', 'placebo', 'intravenous G-CSF and mannitol', 'G-CSF (filgrastim) and mannitol', 'Granulocyte-colony stimulating factor (G-CSF', 'Stem cell transplantation']","['ALS Functional Rating Scale-Revised Score, forced vital capacity, Scale for Testing Muscle Strength Score and quality of life', 'G-CSF levels', 'safety, tolerability and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0002736', 'cui_str': 'ALS (Amyotrophic Lateral Sclerosis)'}]","[{'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0887166', 'cui_str': '(L)-Mannitol'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0034380'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",76.0,0.346543,"We determine increase of G-CSF levels in serum and cerebrospinal fluid as CD34 +  cells and leucocyte count after treatment; reduction in ALS Functional Rating Scale-Revised Score, forced vital capacity, Scale for Testing Muscle Strength Score and quality of life; the adverse events/reactions during the treatment; changes in neuroinflammation biomarkers before and after treatment.
","[{'ForeName': 'Paolina', 'Initials': 'P', 'LastName': 'Salamone', 'Affiliation': ""'Rita Levi Montalcini' Department of Neuroscience, University of Turin, Torino, Piemonte, Italy.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Fuda', 'Affiliation': ""'Rita Levi Montalcini' Department of Neuroscience, University of Turin, Torino, Piemonte, Italy.""}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Casale', 'Affiliation': ""'Rita Levi Montalcini' Department of Neuroscience, University of Turin, Torino, Piemonte, Italy federico.casale@unito.it.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Marrali', 'Affiliation': ""'Rita Levi Montalcini' Department of Neuroscience, University of Turin, Torino, Piemonte, Italy.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lunetta', 'Affiliation': 'NEuroMuscular Omnicentre (NEMO), Fondazione Serena Onlus, Milan, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Caponnetto', 'Affiliation': 'Neurological Clinic, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Mazzini', 'Affiliation': 'Department of Neurology, Maggiore della Carità Hospital, University of Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'La Bella', 'Affiliation': 'Department of Biomedicine, Neuroscience and Advanced Diagnostics, University of Palermo, Palermo, Sicilia, Italy.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mandrioli', 'Affiliation': 'Department of Neuroscience, Azienda Ospedaliera Universitaria Modena, St. Agostino-Estense Hospital, Modena, Italy.'}, {'ForeName': 'Isabella Laura', 'Initials': 'IL', 'LastName': 'Simone', 'Affiliation': 'Neurology Unit, Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari, Bari, Puglia, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Moglia', 'Affiliation': ""'Rita Levi Montalcini' Department of Neuroscience, University of Turin, Torino, Piemonte, Italy.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Calvo', 'Affiliation': ""'Rita Levi Montalcini' Department of Neuroscience, University of Turin, Torino, Piemonte, Italy.""}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Tarella', 'Affiliation': 'Oncohematology Division, IEO European Institute of Oncology, IRCCS, University of Milan, Milano, Lombardia, Italy.'}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Chio', 'Affiliation': ""'Rita Levi Montalcini' Department of Neuroscience, University of Turin, Torino, Piemonte, Italy.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-034049']
603,32209630,Validating the effect of Ondansetron and Mirtazapine In Treating hyperemesis gravidarum (VOMIT): protocol for a randomised placebo-controlled trial.,"INTRODUCTION


Current pharmacological treatment options for hyperemesis gravidarum have been introduced based on scarce evidence and are often not sufficiently effective. Several case reports suggest that mirtazapine, an antidepressant, may be an effective treatment for hyperemesis gravidarum, but so far there are no controlled trials investigating the potential effect of mirtazapine on hyperemesis gravidarum. The antiemetic ondansetron is currently widely used to treat hyperemesis gravidarum despite sparse evidence of effect in pregnant women. This study aims to investigate the effect of mirtazapine on hyperemesis gravidarum while also providing data on the effect of ondansetron.
METHODS AND ANALYSIS


This randomised double-blind placebo-controlled multicentre trial will be conducted in eight Danish hospitals. One hundred and eighty pregnant women referred to secondary care for hyperemesis gravidarum will be randomly allocated to 14-day treatment with either mirtazapine, ondansetron or placebo. Main inclusion criterion will be Pregnancy Unique Quantification of Emesis (PUQE-24) score ≥13 or PUQE-24 score ≥7 if accompanied by weight loss >5% of pre-pregnancy weight or hospitalisation. Participants are eligible regardless of whether other antiemetics, including ondansetron, have been tried. The coprimary outcomes are effects of mirtazapine and ondansetron, respectively, on PUQE-24 score tested hierarchically on day 2 and day 14. Secondary outcomes include, but are not limited to, differences between the three groups in number of daily vomiting episodes, dropout due to treatment failure, use of rescue medication, weight change and side effects.
ETHICS AND DISSEMINATION


The trial has been approved by the Regional Committees on Health Research Ethics in the Capital Region of Denmark, the Danish Medicines Agency and the Danish Data Protection Agency. Results will be published in peer-reviewed journals and submitted to relevant conferences.
TRIAL REGISTRATION NUMBER


NCT03785691.",2020,The antiemetic ondansetron is currently widely used to treat hyperemesis gravidarum despite sparse evidence of effect in pregnant women.,"['eight Danish hospitals', 'One hundred and eighty pregnant women referred to secondary care for hyperemesis gravidarum', 'pregnant women']","['mirtazapine', 'mirtazapine, ondansetron or placebo', 'placebo', 'Ondansetron and Mirtazapine', 'mirtazapine and ondansetron', 'ondansetron', 'antiemetic ondansetron']","['number of daily vomiting episodes, dropout due to treatment failure, use of rescue medication, weight change and side effects']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0020450', 'cui_str': 'Pernicious Vomiting of Pregnancy'}]","[{'cui': 'C0049506', 'cui_str': 'Mirtazapine'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0162643'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",180.0,0.690313,The antiemetic ondansetron is currently widely used to treat hyperemesis gravidarum despite sparse evidence of effect in pregnant women.,"[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ostenfeld', 'Affiliation': 'Department of Gynecology and Obstetrics, Nordsjaellands Hospital, Hillerod, Denmark.'}, {'ForeName': 'Tonny Studsgaard', 'Initials': 'TS', 'LastName': 'Petersen', 'Affiliation': 'Department of Clinical Pharmacology, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Tina Bergmann', 'Initials': 'TB', 'LastName': 'Futtrup', 'Affiliation': 'Department of Gynecology and Obstetrics, Nordsjaellands Hospital, Hillerod, Denmark.'}, {'ForeName': 'Jon Trærup', 'Initials': 'JT', 'LastName': 'Andersen', 'Affiliation': 'Department of Clinical Pharmacology, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Andreas Kryger', 'Initials': 'AK', 'LastName': 'Jensen', 'Affiliation': 'Department of Research, Nordsjaellands Hospital, Hillerod, Denmark.'}, {'ForeName': 'Hanne Brix', 'Initials': 'HB', 'LastName': 'Westergaard', 'Affiliation': 'Department of Gynecology and Obstetrics, Nordsjaellands Hospital, Hillerod, Denmark.'}, {'ForeName': 'Lars Henning', 'Initials': 'LH', 'LastName': 'Pedersen', 'Affiliation': 'Department Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Ellen Christine Leth', 'Initials': 'ECL', 'LastName': 'Løkkegaard', 'Affiliation': 'Department of Gynecology and Obstetrics, Nordsjaellands Hospital, Hillerod, Denmark Ellen.Christine.Leth.Loekkegaard@regionh.dk.'}]",BMJ open,['10.1136/bmjopen-2019-034712']
604,32209643,Maintaining quality of life in patients with chronic obstructive pulmonary disease (COPD) by extending the maintenance phase of community-based pulmonary rehabilitation: protocol for a randomised controlled trial (ComEx3 Study).,"INTRODUCTION


Pulmonary rehabilitation is a core component of the treatment of people with chronic obstructive pulmonary disease (COPD); however, the benefits gained diminish in the ensuing months. The optimal strategy for maintaining the benefits is unclear with weekly supervised maintenance exercise programmes proposed as one strategy. However, the long-term future of maintenance programs is dependent on quality evidence.
METHODS AND ANALYSIS


The ComEx3 randomised controlled trial will investigate the efficacy of extending a weekly supervised maintenance programme for an additional 6 months following an initial 10-week maintenance programme (intervention) by comparing with a control group who receive the same 10-week maintenance programme followed by 6 months of usual care. 120 participants with COPD will be recruited. Primary objective is to determine health-related quality of life over 12 months. Secondary objectives are to determine functional exercise capacity trajectory and to perform an economic evaluation of the intervention to the health system. Outcomes will be analysed for superiority according to intention-to-treat and per-protocol approaches.
ETHICS AND DISSEMINATION


Approval has been received from the relevant ethics committees. Findings will be disseminated in peer-reviewed journals and conferences, targeting those involved in managing people with COPD as well as those who develop policies and guidelines.
CLINICAL TRIAL REGISTRATION


ANZCTR 12618000933257.",2020,The ComEx3 randomised controlled trial will investigate the efficacy of extending a weekly supervised maintenance programme for an additional 6 months following an initial 10-week maintenance programme (intervention) by comparing with a control group who receive the same 10-week maintenance programme followed by 6 months of usual care.,"['patients with chronic obstructive pulmonary disease (COPD', '120 participants with COPD will be recruited', 'people with chronic obstructive pulmonary disease (COPD']",[],"['health-related quality of life', 'Maintaining quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}]",120.0,0.166985,The ComEx3 randomised controlled trial will investigate the efficacy of extending a weekly supervised maintenance programme for an additional 6 months following an initial 10-week maintenance programme (intervention) by comparing with a control group who receive the same 10-week maintenance programme followed by 6 months of usual care.,"[{'ForeName': 'Derrick', 'Initials': 'D', 'LastName': 'Lopez', 'Affiliation': 'School of Population and Global Health, The University of Western Australia, Perth, Western Australia, Australia derrick.lopez@uwa.edu.au.'}, {'ForeName': 'Nola', 'Initials': 'N', 'LastName': 'Cecins', 'Affiliation': 'Physiotherapy Department, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Cockram', 'Affiliation': 'Community Physiotherapy Services, Perth, Western Australia, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Collins', 'Affiliation': 'Community Physiotherapy Services, Perth, Western Australia, Australia.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Landers', 'Affiliation': 'School of Population and Global Health, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Sanfilippo', 'Affiliation': 'School of Population and Global Health, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Briffa', 'Affiliation': 'School of Population and Global Health, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Fraser', 'Initials': 'F', 'LastName': 'Brims', 'Affiliation': 'School of Population and Global Health, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Geelhoed', 'Affiliation': 'School of Allied Health, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Murray', 'Affiliation': 'School of Population and Global Health, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Phillips', 'Affiliation': 'Lung Foundation Australia, Brisbane, Queensland, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Preen', 'Affiliation': 'School of Population and Global Health, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jenkins', 'Affiliation': 'School of Population and Global Health, The University of Western Australia, Perth, Western Australia, Australia.'}]",BMJ open respiratory research,['10.1136/bmjresp-2019-000548']
605,32192596,Androgenicity and fertility treatment in women with unexplained infertility.,"OBJECTIVE


To determine whether biochemical or clinical markers of androgenic activity predict live birth rate with ovarian stimulation in the unexplained infertility population.
DESIGN


Secondary analysis of the Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) clinical trial.
SETTING


Multicenter university-based clinical practices.
PATIENT(S)


Nine hundred couples with unexplained infertility were included. Women were 18-40 years old with regular menses, a normal uterine cavity, at least one patent fallopian tube, and a male partner with ≥5 million motile sperm. Women were randomized to receive gonadotropin, clomiphene, or letrozole with IUI for four or fewer four treatment cycles. Women were evaluated for biochemical (total testosterone, DHEAS, and free androgen index) and clinical markers of androgenic activity (sebum, acne, and hirsutism). Multivariable logistic regression models adjusting for treatment group, maternal age, and body mass index were performed.
INTERVENTION(S)


None.
MAIN OUTCOME MEASURE(S)


The primary outcome was live birth. Secondary outcomes included conception, clinical pregnancy, and pregnancy loss.
RESULT(S)


When comparing 900 women in the AMIGOS trial based on quartiles of serum TT, women were of younger age, higher body mass index, and higher waist circumference with increasing TT. Increasing quartiles of TT also showed increasing DHEAS and free androgen index values. Serum androgens were not associated with outcomes of live birth, conception, clinical pregnancy, or pregnancy loss. Clinical androgen markers were not associated with pregnancy outcomes.
CONCLUSION(S)


In a randomized cohort of women with unexplained infertility, biochemical and clinical measures of androgens did not predict live birth rate after ovarian stimulation treatment.
CLINICAL TRIAL REGISTRATION NUMBER


NCT 01044862.",2020,"In a randomized cohort of women with unexplained infertility, biochemical and clinical measures of androgens did not predict live birth rate after ovarian stimulation treatment.
","['women with unexplained infertility', '900 women in the AMIGOS trial based on quartiles of serum TT, women were of younger age, higher body mass index, and higher waist circumference with increasing TT', 'Women were 18-40 years old with regular menses, a normal uterine cavity, at least one patent fallopian tube, and a male partner with ≥5 million motile sperm', 'Multicenter university-based clinical practices', '\n\n\nNine hundred couples with unexplained infertility were included']","['gonadotropin, clomiphene, or letrozole', 'ovarian stimulation']","['biochemical (total testosterone, DHEAS, and free androgen index) and clinical markers of androgenic activity (sebum, acne, and hirsutism', 'conception, clinical pregnancy, and pregnancy loss', 'live birth rate', 'Serum androgens', 'live birth', 'DHEAS and free androgen index values', 'live birth, conception, clinical pregnancy, or pregnancy loss', 'Androgenicity and fertility treatment']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility (finding)'}, {'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0227844', 'cui_str': 'Endometrial cavity structure'}, {'cui': 'C0030650', 'cui_str': 'Patent'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C4301985', 'cui_str': 'Motile spermatozoa'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C0009008', 'cui_str': 'Clomiphene'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0008963', 'cui_str': 'Markers, Clinical'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036511', 'cui_str': 'Sebum'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0019572', 'cui_str': 'Hirsutism'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0687675', 'cui_str': 'Pregnancy loss'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",900.0,0.40248,"In a randomized cohort of women with unexplained infertility, biochemical and clinical measures of androgens did not predict live birth rate after ovarian stimulation treatment.
","[{'ForeName': 'Erica T', 'Initials': 'ET', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, California. Electronic address: erica.wang@cshs.org.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Diamond', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical College of Georgia, Augusta University, Augusta, Georgia.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Alvero', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Casson', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Christman', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Florida College of Medicine, Gainesville, Florida.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Coutifaris', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Karl R', 'Initials': 'KR', 'LastName': 'Hansen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, Oklahoma.'}, {'ForeName': 'Fangbai', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, Connecticut.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Department of Obstetrics and Gynecology, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Randal D', 'Initials': 'RD', 'LastName': 'Robinson', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Health San Antonio Long School of Medicine, San Antonio, Texas.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Usadi', 'Affiliation': 'Department of Obstetrics and Gynecology, Atrium Health, Charlotte, North Carolina.'}, {'ForeName': 'Margareta D', 'Initials': 'MD', 'LastName': 'Pisarska', 'Affiliation': 'Department of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Nanette F', 'Initials': 'NF', 'LastName': 'Santoro', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, Connecticut.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Fertility and sterility,['10.1016/j.fertnstert.2019.10.034']
606,32402630,Early prevention of complex decongestive therapy and rehabilitation exercise for prevention of lower extremity lymphedema after operation of gynecologic cancer.,"OBJECTIVE


To investigate efficacy of early prevention of complex decongestive therapy and rehabilitation exercise for prevention of postoperative lower limb extremity lymphedema for patients with gynecologic cancer.
METHODS


109 female patients were randomly divided into two groups, the control group who only received routine treatment and the CDT group who received both CDT and rehabilitation exercise. For rehabilitation exercise, patients received additional rehabilitation exercise strategy including professional education and full range exercise of hip joint. The incidence of lower extremity lymphedema was recorded. A simple scale for patients' lower extremity lymphedema was designed. The diameter of low limbs (both thighs and calves) was also measured The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the Brief Fatigue Inventory (BFI) was used for measurement of quality of life.
RESULTS


The incidence of lower extremity lymphedema was 15.09% cases of CDT group and 32.14% in the control group. K-M curve showed the lymphedema free time in CDT group was significantly longer. The subjective scores for heaviness of lower limbs, pain, numbness and dysfunction, as well as the diameters of both thighs and calves were lower in the CDT group. In both groups, the values of EORTC QLQ-C30-GHS and EORTC QLQ-C30-FS were significantly higher, and EORTC QLQ-C30-SS scores and BFI scores were remarkably lower.
CONCLUSION


Early prevention of CDT combined with rehabilitation exercise reduced incidence of lower limb extremity lymphedema and improved patients' quality of life, as well as reduced the cancer-related fatigue.",2020,"Early prevention of CDT combined with rehabilitation exercise reduced incidence of lower limb extremity lymphedema and improved patients' quality of life, as well as reduced the cancer-related fatigue.","['109 female patients', 'patients with gynecologic cancer', 'lower extremity lymphedema after operation of gynecologic cancer']","['complex decongestive therapy and rehabilitation exercise', 'additional rehabilitation exercise strategy including professional education and full range exercise of hip joint', 'CDT combined with rehabilitation exercise', 'control group who only received routine treatment and the CDT group who received both CDT and rehabilitation exercise']","['extremity lymphedema', 'values of EORTC QLQ-C30-GHS and EORTC QLQ-C30-FS', ""patients' quality of life"", 'lymphedema free time', 'European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the Brief Fatigue Inventory (BFI', 'EORTC QLQ-C30-SS scores and BFI scores', 'subjective scores for heaviness of lower limbs, pain, numbness and dysfunction, as well as the diameters of both thighs and calves', 'incidence of lower limb extremity lymphedema', 'incidence of lower extremity lymphedema']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C1275454', 'cui_str': 'Lymphedema of lower extremity'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013647', 'cui_str': 'Professional Education'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0054696', 'cui_str': 'Carbohydrate deficient transferrin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0230429', 'cui_str': 'Both thighs'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1275454', 'cui_str': 'Lymphedema of lower extremity'}]",109.0,0.0182115,"Early prevention of CDT combined with rehabilitation exercise reduced incidence of lower limb extremity lymphedema and improved patients' quality of life, as well as reduced the cancer-related fatigue.","[{'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Department of Gynecology, Nantong First People's Hospital, The Second Affiliated Hospital of Nantong University, Nantong, 226001, China.""}, {'ForeName': 'Yinglei', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Gynecology, Nantong First People's Hospital, The Second Affiliated Hospital of Nantong University, Nantong, 226001, China.""}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': ""Department of Gynecology, Nantong First People's Hospital, The Second Affiliated Hospital of Nantong University, Nantong, 226001, China.""}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': ""Department of Nursing, Nantong First People's Hospital, The Second Affiliated Hospital of Nantong University, Nantong, 226001, China. Electronic address: wf191203@yeah.net.""}, {'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Ji', 'Affiliation': ""Department of ICU, Nantong First People's Hospital, The Second Affiliated Hospital of Nantong University, Nantong, 226001, China.""}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': ""Department of Cerebral Surgery, Nantong First People's Hospital, The Second Affiliated Hospital of Nantong University, Nantong, 226001, China.""}]",Asian journal of surgery,['10.1016/j.asjsur.2020.03.022']
607,32402553,"Visual Field Outcomes from the Multicenter, Randomized Controlled Laser in Glaucoma and Ocular Hypertension Trial.","PURPOSE


To compare visual field outcomes of ocular hypertensive and glaucoma patients treated first with medical therapy with those treated first with selective laser trabeculoplasty (SLT).
DESIGN


Secondary analysis of patients from the Laser in Glaucoma and Ocular Hypertension study, a multicenter randomized controlled trial.
PARTICIPANTS


Three hundred forty-four patients (588 eyes) treated first with medical therapy and 344 patients (590 eyes) treated first with SLT.
METHODS


Visual fields (VFs) were measured using standard automated perimetry and arranged in series (median length and duration, 9 VFs over 48 months). Hierarchical linear models were used to estimate pointwise VF progression rates, which were then averaged to produce a global progression estimate for each eye. Proportions of points and patients in each treatment group with fast (<-1 dB/year) or moderate (<-0.5 dB/year) progression were compared using log-binomial regression.
MAIN OUTCOME MEASURES


Pointwise and global progression rates of total deviation (TD) and pattern deviation (PD).
RESULTS


A greater proportion of eyes underwent moderate or fast TD progression in the medical therapy group compared with the SLT group (26.2% vs. 16.9%; risk ratio [RR], 1.55; 95% confidence interval [CI], 1.23-1.93; P < 0.001). A similar pattern was observed for pointwise rates (medical therapy, 26.1% vs. SLT, 19.0%; RR, 1.37; 95% CI, 1.33-1.42; P < 0.001). A greater proportion of pointwise PD rates were categorized as moderate or fast in the medical therapy group (medical therapy, 11.5% vs. SLT, 8.3%; RR, 1.39; 95% CI, 1.32-1.46; P < 0.001). No statistical difference was found in the proportion of eyes that underwent moderate or fast PD progression (medical therapy, 9.9% vs. SLT, 7.1%; RR, 1.39; 95% CI, 0.95, 2.03; P = 0.0928).
CONCLUSIONS


A slightly larger proportion of ocular hypertensive and glaucoma patients treated first with medical therapy underwent rapid VF progression compared with those treated first with SLT.",2020,"No statistical difference was found in the proportion of eyes that underwent moderate or fast PD progression (medical therapy, 9.9% vs. SLT, 7.1%; RR, 1.39; 95% CI, 0.95, 2.03; P = 0.0928).
","['patients from the Laser in Glaucoma and Ocular Hypertension study', 'Three hundred forty-four patients (588 eyes) treated first with medical therapy and 344 patients (590 eyes) treated first with', 'ocular hypertensive and glaucoma patients treated first with']","['medical therapy', 'SLT', 'selective laser trabeculoplasty (SLT']","['pointwise rates', 'fast TD progression', 'proportion of eyes that underwent moderate or fast PD progression', 'pointwise PD rates', 'Pointwise and global progression rates of total deviation (TD) and pattern deviation (PD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0851409', 'cui_str': 'Glaucoma and ocular hypertension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C5191356', 'cui_str': '590'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}]","[{'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C1271447', 'cui_str': 'Selective laser trabeculoplasty'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.0639216,"No statistical difference was found in the proportion of eyes that underwent moderate or fast PD progression (medical therapy, 9.9% vs. SLT, 7.1%; RR, 1.39; 95% CI, 0.95, 2.03; P = 0.0928).
","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Wright', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast, United Kingdom; Health Data Research UK, London, United Kingdom. Electronic address: David.Crabb1@city.ac.uk.""}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Konstantakopoulou', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom; Institute of Ophthalmology, University College London, United Kingdom; Division of Optics and Optometry, University of West Attica, Athens, Greece.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Montesano', 'Affiliation': 'Optometry and Visual Science, School of Health Science, City, University of London, London, United Kingdom.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Nathwani', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Garg', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Garway-Heath', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom; Institute of Ophthalmology, University College London, United Kingdom.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Crabb', 'Affiliation': 'Optometry and Visual Science, School of Health Science, City, University of London, London, United Kingdom.'}, {'ForeName': 'Gus', 'Initials': 'G', 'LastName': 'Gazzard', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom; Institute of Ophthalmology, University College London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.03.029']
608,32402554,"Five-Year Outcomes after Initial Aflibercept, Bevacizumab, or Ranibizumab Treatment for Diabetic Macular Edema (Protocol T Extension Study).","PURPOSE


Assess follow-up treatment and clinical outcomes at 5 years in eyes initially treated with anti-VEGF therapy for center-involved diabetic macular edema (CI-DME) in a 2-year randomized clinical trial.
DESIGN


Multicenter cohort study.
PARTICIPANTS


Participants with diabetic macular edema (DME) and visual acuity (VA) 20/32 to 20/320 enrolled in DRCR.net Protocol T with visits 5 years after randomization (3 years after Protocol T completion).
METHODS


Participants were assigned randomly to aflibercept, bevacizumab, or ranibizumab with protocol-defined follow-up and re-treatment for 2 years. Thereafter, participants were managed at clinician discretion and recalled for a 5-year visit.
MAIN OUTCOME MEASURES


Anti-vascular endothelial growth factor (VEGF) treatment, VA letter score, and central subfield thickness (CST).
RESULTS


Sixty-eight percent (317/463) of eligible participants completed the 5-year visit. Between years 2 and 5, 68% (217/317) of study eyes received at least 1 anti-VEGF treatment (median, 4; interquartile range [IQR], 0-12). At 5 years, mean VA improved from baseline by 7.4 letters (95% confidence interval [CI], 5.9-9.0) but decreased by 4.7 letters (95% CI, 3.3-6.0) between 2 and 5 years. When baseline VA was 20/50 to 20/320, mean 5-year VA was 11.9 letters (95% CI, 9.3-14.5) better than baseline but 4.8 letters (95% CI, 2.5-7.0) worse than 2 years. When baseline VA was 20/32 to 20/40, mean 5-year VA was 3.2 letters (95% CI, 1.4-5.0) better than baseline but 4.6 letters (95% CI, 3.1-6.1) worse than 2 years. Mean CST decreased from baseline to 5 years by 154 μm (95% CI, 142-166) and was stable between 2 and 5 years (-1 μm; 95% CI, -12 to 9).
CONCLUSIONS


Among the two-thirds of eligible Protocol T participants who completed a 5-year visit, mean VA improved from baseline to 5 years without protocol-defined treatment after follow-up ended at 2 years. Although mean retinal thickness was similar at 2 and 5 years, mean VA worsened during this period. Additional investigation into strategies to improve long-term outcomes in eyes with DME seems warranted to determine if VA can be better maintained with different management approaches.",2020,"At 5 years, mean VA improved from baseline by 7.4 letters (95% confidence interval [CI], 5.9-9.0) but decreased by 4.7 letters (95% CI, 3.3-6.0) between 2 and 5 years.","['Participants', 'Participants with diabetic macular edema (DME) and visual acuity (VA) 20/32 to 20/320 enrolled in DRCR.net Protocol T with visits 5 years after randomization (3 years after Protocol T completion', 'for center-involved diabetic macular edema (CI-DME', 'eyes with DME']","['anti-VEGF therapy', 'aflibercept, bevacizumab, or ranibizumab with protocol-defined follow-up and re-treatment', 'Aflibercept, Bevacizumab, or Ranibizumab']","['Anti-vascular endothelial growth factor (VEGF) treatment, VA letter score, and central subfield thickness (CST', '5-year visit, mean VA', '5-year visit', 'mean 5-year VA', 'Mean CST', 'mean retinal thickness', 'mean VA']","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C4727875', 'cui_str': 'Anti-vascular endothelial growth factor therapy'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}]",,0.306087,"At 5 years, mean VA improved from baseline by 7.4 letters (95% confidence interval [CI], 5.9-9.0) but decreased by 4.7 letters (95% CI, 3.3-6.0) between 2 and 5 years.","[{'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Glassman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida. Electronic address: drcrstat2@jaeb.org.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Wells', 'Affiliation': 'Palmetto Retina Center, Columbia, South Carolina.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Josic', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Antoszyk', 'Affiliation': 'Charlotte Eye, Ear, Nose and Throat Associates, Charlotte, North Carolina.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Baker', 'Affiliation': 'Paducah Retinal Center, Paducah, Kentucky.'}, {'ForeName': 'Wesley T', 'Initials': 'WT', 'LastName': 'Beaulieu', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Elman', 'Affiliation': 'Elman Retina Group, Pikesville, Maryland.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Jampol', 'Affiliation': 'Feinberg School of Medicine, Northwestern University Medical School, Chicago, Illinois.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Sun', 'Affiliation': 'Joslin Diabetes Center, Beetham Eye Institute, Harvard Department of Ophthalmology, Boston, Massachusetts.'}]",Ophthalmology,['10.1016/j.ophtha.2020.03.021']
609,32203207,Long-term cardiac outcomes of patients with HER2-positive breast cancer treated in the adjuvant lapatinib and/or trastuzumab Treatment Optimization Trial.,"BACKGROUND


Cardiotoxicity is the most significant adverse event associated with trastuzumab (T), the main component of HER2-positive breast cancer (BC) treatment. Less is known about the cardiotoxicity of dual HER2 blockade with T plus lapatinib (L), although this regimen is used in the metastatic setting.
METHODS


This is a sub-analysis of the ALTTO trial comparing adjuvant treatment options for patients with early HER2-positive BC. Patients randomised to either T or concomitant T + L were eligible. Cardiac events (CEs) rates were compared according to treatment arm.
RESULTS


With 6.9 years of median follow-up (FU) and 4190 patients, CE were observed in 363 (8.6%): 166 (7.9%) of patient in T + L arm vs. 197 (9.3%) in T arm (OR = 0.85 [95% CI, 0.68-1.05]). During anti-HER2 treatment 270 CE (6.4%) occurred while 93 (2.2%) were during FU (median time to onset = 6.6 months [IQR = 3.4-11.7]). While 265 CEs were asymptomatic (73%), 94 were symptomatic (26%) and four were cardiac deaths (1%). Recovery was observed in 301 cases (83.8%). Identified cardiac risk factors were: baseline LVEF < 55% (vs > 64%, OR 3.1 [95% CI 1.54-6.25]), diabetes mellitus (OR 1.85 [95% CI 1.25-2.75]), BMI > 30 kg/m 2  (vs < 25 mg/kg 2 , OR 2.21 [95% CI 1.40-3.49]), cumulative dose of doxorubicin ≥240 mg/m 2  (OR 1.36 [95% CI 1.01-1.82]) and of epirubicin≥ 480 mg/m 2  (OR 2.33 [95% CI 1.55-3.51]).
CONCLUSIONS


Dual HER2 blockade with T + L is a safe regimen from a cardiac perspective, but cardiac-focused history for proper patient selection is crucial.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Identifier: NCT00490139 (registration date: 22/06/2007); EudraCT Number: 2006-000562-36 (registration date: 04/05/2007); Sponsor Protocol Number: BIG2-06 /EGF106708/N063D.",2020,"Cardiac events (CEs) rates were compared according to treatment arm.
","['patients with early HER2-positive BC', 'patients with HER2-positive breast cancer treated in the']","['trastuzumab (T', 'adjuvant lapatinib', 'T or concomitant T\u2009+\u2009L', 'doxorubicin']","['diabetes mellitus', 'Cardiac events (CEs) rates', 'Recovery', 'cardiac deaths']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}]",,0.264623,"Cardiac events (CEs) rates were compared according to treatment arm.
","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Eiger', 'Affiliation': ""Institut Jules Bordet Institute and L'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.""}, {'ForeName': 'Noam F', 'Initials': 'NF', 'LastName': 'Pondé', 'Affiliation': ""Institut Jules Bordet Institute and L'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Agbor-Tarh', 'Affiliation': 'Frontier Science, Kingussie, United Kingdom.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Moreno-Aspitia', 'Affiliation': 'Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': ""Institut Jules Bordet Institute and L'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.""}, {'ForeName': 'Florentine S', 'Initials': 'FS', 'LastName': 'Hilbers', 'Affiliation': 'Breast International Group (BIG), Brussels, Belgium.'}, {'ForeName': 'Olena', 'Initials': 'O', 'LastName': 'Werner', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Saranya', 'Initials': 'S', 'LastName': 'Chumsri', 'Affiliation': 'Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Amylou', 'Initials': 'A', 'LastName': 'Dueck', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'Judith R', 'Initials': 'JR', 'LastName': 'Kroep', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Gomez', 'Affiliation': 'Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru.'}, {'ForeName': 'István', 'Initials': 'I', 'LastName': 'Láng', 'Affiliation': 'Istenhegyi Géndiagnosztika Private Health Center, Oncology Clinic, Budapest, Hungary.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Rodeheffer', 'Affiliation': 'Cardiovascular Department, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Ewer', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Suter', 'Affiliation': 'Department of Cardiology, lnselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Evandro', 'Initials': 'E', 'LastName': 'de Azambuja', 'Affiliation': ""Institut Jules Bordet Institute and L'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium. evandro.azambuja@bordet.be.""}]",British journal of cancer,['10.1038/s41416-020-0786-x']
610,32402480,Treatment of Headache in the Emergency Department: Haloperidol in the Acute Setting (THE-HA Study): A Randomized Clinical Trial.,"BACKGROUND


Headache is a common complaint of emergency department (ED) patients and current treatment varies with significant limitations.
OBJECTIVE


Our aim was to evaluate the efficacy and safety of 2.5 mg i.v. haloperidol in the treatment of severe benign headache in the ED.
METHODS


A randomized, double-blind, placebo-controlled trial was performed in the ED of a single high-volume teaching hospital. Convenience sampling identified 287 eligible patients 13 to 55 years old with benign headache. One hundred and eighteen patients were enrolled to receive either 2.5 mg of haloperidol i.v. or placebo. The primary outcome measure was pain reduction at 60 min. Patients were evaluated for adverse events and follow-up was conducted after discharge. QT measurement was performed at baseline and discharge.
RESULTS


Fifty-eight patients received haloperidol and 60 patients received placebo. Patients in the haloperidol group reported an average 4.77-unit reduction in visual analogue scale score at 60 min compared to a 1.87-unit reduction in the control group. Thirty-four patients (58.6%) in the haloperidol group had complete resolution of their headache. Treatment with rescue ketorolac was required in 78.3% of the control group and 31% of the haloperidol group. Adverse events were uncommon, benign, and easily treated. No patients in the haloperidol group were found to have QT lengthening.
CONCLUSIONS


This study suggests that 2.5 mg i.v. haloperidol is a rapid and effective treatment for acute, severe, benign headache in ED patients aged 18 to 55 years. Further study is warranted to confirm these results in adolescents.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT02747511.",2020,"haloperidol is a rapid and effective treatment for acute, severe, benign headache in ED patients aged 18 to 55 years.","['One hundred and eighteen patients', 'ED of a single high-volume teaching hospital', '287 eligible patients 13 to 55\xa0years old with benign headache', 'ED patients aged 18 to 55\xa0years', 'adolescents']","['haloperidol i.v', 'ketorolac', 'haloperidol', 'placebo']","['pain reduction', 'QT measurement', 'severe benign headache', 'visual analogue scale score', 'efficacy and safety', 'adverse events', 'complete resolution of their headache', 'QT lengthening']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0441592', 'cui_str': 'Surgical lengthening - action'}]",118.0,0.113547,"haloperidol is a rapid and effective treatment for acute, severe, benign headache in ED patients aged 18 to 55 years.","[{'ForeName': 'Jessica J', 'Initials': 'JJ', 'LastName': 'McCoy', 'Affiliation': 'Department of Emergency Medicine, Western Michigan University, Homer Stryker M.D. School of Medicine, Kalamazoo, Michigan.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Aldy', 'Affiliation': 'Department of Emergency Medicine, Western Michigan University, Homer Stryker M.D. School of Medicine, Kalamazoo, Michigan.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Arnall', 'Affiliation': 'Department of Emergency Medicine, Western Michigan University, Homer Stryker M.D. School of Medicine, Kalamazoo, Michigan.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Petersen', 'Affiliation': 'Emergency Department, Bronson Methodist Hospital, Kalamazoo, Michigan.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2020.04.018']
611,32402495,Non-suturing microvascular anastomosis in maxillofacial reconstruction- a comparative study.,"AIM


The aim of the study is to compare the advantages and disadvantages of non-suturing anastomotic methods over conventional microsuturing for microvascular venous anastomosis.
MATERIALS AND METHODS


All patients reporting to the institute for hard and soft tissue reconstruction (Primary/secondary) were enrolled in the study. Patients with systemic comorbidities, peripheral vascular diseases, or anatomical aberration of the indicated donor site were excluded from the study. The patients selected for the study were randomly allocated to five groups of different techniques of venous anastomosis, namely Group I (conventional microsuturing), II (fibrin sealant reinforced microsuturing), III (couplers), IV (staplers), V (Laser Assisted Vascular Anastomosis (LAVA)). Intraoperative anastomotic time, flap ischaemic time, patency and leakage were the parameters that were assessed for all five groups.
RESULTS


80 Patients were randomly allocated to five groups and each group comprised 16 patients. The mean ischaemic time and standard deviation of Group I and Group II were 256.19 ± 10.622 min and 255.19 ± 11.083 min, and for groups III, IV, and V were 193.38 ± 9.972 min, 139.06 ± 6.413 min, and 139.31 ± 6.364 min respectively (p < 0.001). Mean anastomotic time and standard deviation were 19.813 ± 1.5366 min in Group I and 20.281 ± 1.6514 min in Group II. The non-sutured anastomosis groups III, IV, and V showed a mean anastomotic time of 5.375 ± 0.9876 min, 4.175 ± 0.7664 min, and 3.856 ± 0.867 min respectively (p value < 0.001). In Groups I and II, 18.8% of patients had delayed patency and in Groups III, IV and V, immediate patency was observed in all subjects (p value 0.030). In Groups I and II, 18.8% and 6.3 % of patients respectively had leakage, whereas all patients in Groups III, IV, V had no leakage from the anastomotic site (p value 0.119).
CONCLUSION


Based on the results of the study, non-suturing techniques should be preferred over microsuturing technique whenever appropriate for venous anastomosis.",2020,"In Groups I and II, 18.8% of patients had delayed patency and in Groups III, IV and V, immediate patency was observed in all subjects (p value 0.030).","['Patients with systemic comorbidities, peripheral vascular diseases, or anatomical aberration of the indicated donor site were excluded from the study', 'All patients reporting to the institute for hard and soft tissue reconstruction (Primary/secondary) were enrolled in the study', '80 Patients']","['venous anastomosis, namely Group I (conventional microsuturing), II (fibrin sealant reinforced microsuturing), III (couplers), IV (staplers), V (Laser Assisted Vascular Anastomosis (LAVA']","['Mean anastomotic time and standard deviation', 'mean ischaemic time and standard deviation', 'mean anastomotic time', 'leakage', 'Intraoperative anastomotic time, flap ischaemic time, patency and leakage', 'delayed patency', 'immediate patency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1444716', 'cui_str': 'Donor site'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0450432', 'cui_str': 'Venous anastomosis'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016004', 'cui_str': 'Autologous Fibrin Tissue Adhesive'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C3665740', 'cui_str': 'Vascular anastomosis'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0677554', 'cui_str': 'Anastomosis - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]",80.0,0.0156835,"In Groups I and II, 18.8% of patients had delayed patency and in Groups III, IV and V, immediate patency was observed in all subjects (p value 0.030).","[{'ForeName': 'Surya Kiran', 'Initials': 'SK', 'LastName': 'Mudigonda', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu, 600089, India. Electronic address: mudigondasuryakiran@gmail.com.'}, {'ForeName': 'Senthil', 'Initials': 'S', 'LastName': 'Murugan', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Saveetha Dental College, 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu, 600077, India. Electronic address: drmsenthilmurugan@gmail.com.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Velavan', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu, 600089, India. Electronic address: drvelavan@gmail.com.'}, {'ForeName': 'Selvakumar', 'Initials': 'S', 'LastName': 'Thulasiraman', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu, 600089, India. Electronic address: selvakumaromfs@gmail.com.'}, {'ForeName': 'V B', 'Initials': 'VB', 'LastName': 'Krishna Kumar Raja', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu, 600089, India. Electronic address: kksukanya@gmail.com.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2020.04.005']
612,32402496,Does platelet-rich fibrin increase stability of the maxilla following Le Fort I osteotomy? A single-blind clinical trial study.,"This single-blind clinical trial study aimed to assess the efficacy of platelet-rich fibrin (PRF) in increasing stability following Le Fort I osteotomy for maxillary advancement. Patients who underwent Le Fort I osteotomy for maxillary advancement were assigned randomly into two groups: in group 1 (the study group, n = 22) PRF was placed in the osteotomy sites following fixation, while no PRF was used in group 2 (the control group, n = 22). Lateral cephalograms obtained preoperatively (T0), immediately after surgery (T1), and 1 year after surgery (T2) were compared between the two groups, and the amount of relapse was determined. The amount of maxillary change (relapse) at the A point in relation to the x-axis was 0.45 ± 0.67 mm in group 1 and 1.86 ± 0.56 mm in group 2. There was a significant difference in mean relapse in relation to the x-axis between the two groups 12 months after osteotomy (p < 0.001). The mean maxillary change (relapse) in relation to the y-axis was 0.77 ± 1.15 mm in group 1 and 2.25 ± 1.22 mm in group 2. Analysis of the data demonstrated a significant difference in mean relapse in relation to the y-axis between the two groups (p < 0.001). PRF may enhance the stability of the maxilla following Le Fort I osteotomy. Based on the results of this study the administration of PRF should be considered whenever possible.",2020,There was a significant difference in mean relapse in relation to the x-axis between the two groups 12 months after osteotomy (p < 0.001).,"['I osteotomy for maxillary advancement', 'Patients who underwent Le Fort']","['PRF', 'platelet-rich fibrin (PRF', 'PRF was placed in the osteotomy sites following fixation, while no PRF']","['amount of maxillary change (relapse', 'mean relapse', 'mean maxillary change (relapse']","[{'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.034354,There was a significant difference in mean relapse in relation to the x-axis between the two groups 12 months after osteotomy (p < 0.001).,"[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Tabrizi', 'Affiliation': 'Oral and Maxillofacial Surgery, Dental School, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Mirmohammad Sadeghi', 'Affiliation': 'Oral and Maxillofacial Surgery, Dental School, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pedram', 'Initials': 'P', 'LastName': 'Bakhshaei', 'Affiliation': 'Oral and Maxillofacial Surgery, Dental School, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: Bakhshaei.pedram@gmail.com.'}, {'ForeName': 'Birkan Taha', 'Initials': 'BT', 'LastName': 'Ozkan', 'Affiliation': 'Oral and Maxillofacial Surgery, Toros University, Institute of Health Science, Toros, Turkey.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2020.04.007']
613,32402504,"Response to Letter Regarding ""A Randomized Controlled Trial on the Effects of Low-Dose Extracorporeal Shockwave Therapy in Patients With Knee Osteoarthritis"".",,2020,,['Patients With Knee Osteoarthritis'],['Low-Dose Extracorporeal Shockwave Therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}]",[],,0.046562,,"[{'ForeName': 'Zongye', 'Initials': 'Z', 'LastName': 'Zhong', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Bangzhong', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Guanghua', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Deparment of Radiology, Huashan Hospital, Fudan University, Shanghai, China.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.008']
614,32402523,Treatment Adequacy and Adherence as Predictors of Depression Response in Primary Care.,"OBJECTIVE


Primary care is the de facto mental health system in the United States where physicians treat large numbers of depressed older adults with antidepressant medication. This study aimed to examine whether antidepressant dosage adequacy and patient adherence are associated with depression response among middle-aged and older adults prescribed with antidepressants by their primary care provider.
DESIGN


A secondary analysis was conducted on a sample drawn from a randomized controlled trial comparing Treatment as Usual to Treatment Initiation Program, an adherence intervention. Treatment Initiation Program improved adherence but not depression compared to Treatment as Usual (Sirey et al., 2017). For this analysis, we examined dosing adequacy and adherence at 6 and 12 weeks as predictors of depression response in both groups at 12 and 24 weeks.
SETTING


Primary care practices.
PARTICIPANTS


One hundred eighty-seven older adults with depression prescribed an antidepressant for depression by their primary care provider.
MEASUREMENTS


Depression response was defined as 50% reduction on the Hamilton Rating Scale for Depression. Adherence was defined as taking 80% of doses at follow-up interviews (6 and 12 weeks). Patient-reported dosage and duration of antidepressant therapy was collected using the Composite Antidepressant Score (adequacy score of >3) at follow-up.
RESULTS


Greater adherence, but not receipt of adequate dosage, was associated with higher likelihood of treatment response at both 12 (Odds ratio (OR) = 2.63; 95% Confidence Interval (CI), 1.19-5.84) and 24 weeks (OR = 3.09; 95% CI, 1.46-6.55).
CONCLUSION


As physicians prescribe antidepressants to the diverse group of adults seen in primary care, special attention to patients' views and approach to adherence may improve depression outcomes.",2020,"Greater adherence, but not receipt of adequate dosage, was associated with higher likelihood of treatment response at both 12 (Odds ratio (OR) = 2.63; 95% Confidence Interval (CI), 1.19-5.84) and 24 weeks (OR = 3.09; 95% CI, 1.46-6.55).
","['middle-aged and older adults prescribed with antidepressants by their primary care provider', 'One hundred eighty-seven older adults with depression prescribed an antidepressant for depression by their primary care provider', 'depressed older adults with antidepressant medication', 'Primary care practices']",[],"['Greater adherence', 'Depression response', 'Hamilton Rating Scale for Depression', 'depression response', 'Adherence']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],"[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}]",187.0,0.0742356,"Greater adherence, but not receipt of adequate dosage, was associated with higher likelihood of treatment response at both 12 (Odds ratio (OR) = 2.63; 95% Confidence Interval (CI), 1.19-5.84) and 24 weeks (OR = 3.09; 95% CI, 1.46-6.55).
","[{'ForeName': 'Jo Anne', 'Initials': 'JA', 'LastName': 'Sirey', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College (JAS, AW, NS, PZ, GA). Electronic address: jsirey@med.cornell.edu.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Woods', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College (JAS, AW, NS, PZ, GA).'}, {'ForeName': 'Nili', 'Initials': 'N', 'LastName': 'Solomonov', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College (JAS, AW, NS, PZ, GA).'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Evans', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medicine (LE, SB).'}, {'ForeName': 'Samprit', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medicine (LE, SB).'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Zanotti', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College (JAS, AW, NS, PZ, GA).'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Alexopoulos', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College (JAS, AW, NS, PZ, GA).'}, {'ForeName': 'Helen C', 'Initials': 'HC', 'LastName': 'Kales', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California at Davis (HCK).'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.04.014']
615,32403130,"Remission of type 2 diabetes following a short-term intervention with insulin glargine, metformin and dapagliflozin.","OBJECTIVE


To examine diabetes remission following a short-term intensive metabolic intervention combining lifestyle and glucose-lowering approaches.
METHODS


We conducted an open-label randomized controlled trial in 154 patients with type 2 diabetes up to 8 years in duration on 0-2 glucose-lowering medications. Participants were randomized to: (i) a 12-week intensive intervention comprising lifestyle approaches and treatment with insulin glargine, metformin and dapagliflozin or (ii) standard diabetes care. At 12 weeks, diabetes medications were discontinued in participants with HbA1C<7.3% [56 mmol/mol]. Participants were then followed for diabetes relapse until 64 weeks. The primary outcome was complete or partial diabetes remission (HbA1C<6.5% [48 mmol/mol] off chronic diabetes drugs) at 24 weeks. Main secondary outcomes were complete or partial diabetes remission at 36, 48 and 64 weeks.
RESULTS


The primary outcome was achieved in 19 (24.7%) intervention group participants and 13 (16.9%) control group participants at 24 weeks (RR 1.5, 95% CI 0.8-2.7). The relative risks of remission at 36, 48 and 64 weeks were 2.4 (95% CI 1.2-5.0), 2.1 (95% CI 1.0-4.4) and 1.8 (95% CI 0.7-4.7) respectively. In an exploratory analysis, the intervention reduced the hazard of diabetes relapse with overt hyperglycemia by 43% (HR 0.57, 95% CI 0.39-0.81).
CONCLUSIONS


Our primary outcome of diabetes remission at 24 weeks was not statistically significantly different. However, our overall results suggest that some patients with early type 2 diabetes are able to achieve sustained diabetes remission following a short-term intensive intervention. Further studies are needed to optimize the combined therapeutic approach used.",2020,"The relative risks of remission at 36, 48 and 64 weeks were 2.4 (95% CI 1.2-5.0), 2.1 (95% CI 1.0-4.4) and 1.8 (95% CI 0.7-4.7) respectively.",['154 patients with type 2 diabetes up to 8 years in duration on 0-2 glucose-lowering medications'],"['insulin glargine, metformin and dapagliflozin', 'short-term intensive metabolic intervention combining lifestyle and glucose-lowering approaches', 'intensive intervention comprising lifestyle approaches and treatment with insulin glargine, metformin and dapagliflozin or (ii) standard diabetes care']","['diabetes medications', 'hazard of diabetes relapse with overt hyperglycemia', 'diabetes remission', 'sustained diabetes remission', 'relative risks of remission', 'complete or partial diabetes remission']","[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C3700400', 'cui_str': 'metformin and dapagliflozin'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0728938', 'cui_str': 'Partial'}]",154.0,0.193999,"The relative risks of remission at 36, 48 and 64 weeks were 2.4 (95% CI 1.2-5.0), 2.1 (95% CI 1.0-4.4) and 1.8 (95% CI 0.7-4.7) respectively.","[{'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'McInnes', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Hall', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Sultan', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'LMC Diabetes and Endocrinology Community Practice, Toronto, Ontario, Canada.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Hramiak', 'Affiliation': 'Western University, London, Ontario, Canada.'}, {'ForeName': 'Stewart', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'Western University, London, Ontario, Canada.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Sigal', 'Affiliation': 'University of Calgary, Calgary, Canada.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Woo', 'Affiliation': 'University of Manitoba, Winnipeg, Manitoba.'}, {'ForeName': 'Yan Yun', 'Initials': 'YY', 'LastName': 'Liu', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa248']
616,32403158,"Stenting the ureteroneocystostomy reduces urological complications in kidney transplantation: a non-inferiority randomized controlled trial, SPLINT-trial.","The role of ureteral stents in living donor kidney transplantation remains uncertain. In this randomized controlled trial (SPLINT), we compared urological complications in living donor kidney transplantations performed with or without stents. We included 200 consecutive patients that received living donor kidney transplantations at the Erasmus MC, University Medical Center Rotterdam. Patients (124 males, 76 females, mean age 54 ± 13) were randomized for suprapubic externalized single J stents (N=100) or no stent (N=100). The primary outcome was the probability of a percutaneous nephrostomy insertion (PCN) during a 12-month follow-up. To assess whether no stenting is non inferior to stenting, we allowed the probability of a PCN to increase by at most 5% (this is the non-inferiority margin). Baseline characteristics were comparable between groups. In the no stent group, there were more PCN insertions 14% (95%CI 4.3- 23.7%), urinary leakages 12% (95%CI 5.4- 21.3%) and surgical re-interventions due to urological complications 8% (95%CI 1.5- 14.5%). The stent group had more hematuria 26% (95%CI 13.1- 38.9%) and graft rejections 15% (95%CI 2.7- 27.3%). Patients in both groups had similar mean GFRs at several time points. Besides a better Euro-Qol-5D in the no stent group at 2 and 6 weeks postoperative, similar quality of life was reported based on SF-36 and Euro-Qol-5D scores. In this trial, non-inferiority has not been demonstrated for no stent placement in relation to the number urological complications.",2020,The stent group had more hematuria 26% (95%CI 13.1- 38.9%) and graft rejections 15% (95%CI 2.7- 27.3%).,"['kidney transplantation', '200 consecutive patients that received living donor kidney transplantations at the Erasmus MC, University Medical Center Rotterdam', 'Patients (124 males, 76 females, mean age 54 ± 13']","['ureteral stents', 'suprapubic externalized single J stents (N=100) or no stent', 'ureteroneocystostomy', 'living donor kidney transplantations performed with or without stents']","['quality of life', 'urological complications', 'hematuria', 'probability of a percutaneous nephrostomy insertion (PCN', 'graft rejections', 'urinary leakages']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0183518', 'cui_str': 'Ureteric stent'}, {'cui': 'C0205498', 'cui_str': 'Suprapubic approach'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0194307', 'cui_str': 'Intravesical reimplantation of ureter'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0027724', 'cui_str': 'Percutaneous insertion of nephrostomy tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0018129', 'cui_str': 'Graft rejection'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}]",200.0,0.322335,The stent group had more hematuria 26% (95%CI 13.1- 38.9%) and graft rejections 15% (95%CI 2.7- 27.3%).,"[{'ForeName': 'L S S', 'Initials': 'LSS', 'LastName': 'Ooms', 'Affiliation': 'Department of Surgery, Erasmus , MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Minnee', 'Affiliation': 'Department of Surgery, Erasmus , MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'F J M F', 'Initials': 'FJMF', 'LastName': 'Dor', 'Affiliation': 'Department of Surgery, Erasmus , MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'H J A N', 'Initials': 'HJAN', 'LastName': 'Kimenai', 'Affiliation': 'Department of Surgery, Erasmus , MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'T C K', 'Initials': 'TCK', 'LastName': 'Tran', 'Affiliation': 'Department of Surgery, Erasmus , MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hartog', 'Affiliation': 'Department of Surgery, Erasmus , MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van de Wetering', 'Affiliation': 'Department of Nephrology, Erasmus , MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Willemsen', 'Affiliation': 'Department of Biostatistics, Erasmus , MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'J N M', 'Initials': 'JNM', 'LastName': 'IJzermans', 'Affiliation': 'Department of Surgery, Erasmus , MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Terkivatan', 'Affiliation': 'Department of Surgery, Erasmus , MC, University Medical Center, Rotterdam, The Netherlands.'}]",Transplant international : official journal of the European Society for Organ Transplantation,['10.1111/tri.13638']
617,32403207,The effect of insemination methods on in vitro maturation outcomes.,"Objective


The aim of this study was to compare the effects of conventional insemination (in vitro fertilization [IVF]) and intracytoplasmic sperm injection (ICSI) on the fertilization, developmental competence, implantation potential, and clinical pregnancy rate of embryos derived from in vitro matured oocytes of patients with polycystic ovary syndrome (PCOS).
Methods


A prospective study was carried out among 38 PCOS patients who had undergone in vitro maturation (IVM) treatment. In total, 828 immature oocytes were collected from 42 cycles and randomly assigned for insemination by IVF (416 oocytes) or ICSI (412 oocytes). After fertilization, the embryos were cultured until the blastocyst stage and single embryos were transferred after endometrial preparation and under ultrasound guidance.
Results


No significant differences were found in the maturation rate (78.1% vs. 72.6% for IVF and ICSI insemination, respectively; p= 0.076), fertilization rate (59.4% vs. 66.9% for IVF and ICSI insemination, respectively; p= 0.063), or the formation of good-quality blastocysts (40.9% vs. 46.5% for IVF and ICSI insemination, respectively; p= 0.314). Implantation and clinical pregnancy also did not show significant differences.
Conclusion


There was a comparable yield of in vitro matured oocytes derived from PCOS patients in terms of fertilization, blastocyst formation, implantation rate, and clinical pregnancy between IVF and ICSI insemination. These findings provide valuable insights for choosing assisted reproductive treatment in women with PCOS, as IVM offers promising outcomes and is less invasive and less costly.",2020,"There was a comparable yield of in vitro matured oocytes derived from PCOS patients in terms of fertilization, blastocyst formation, implantation rate, and clinical pregnancy between IVF and ICSI insemination.","['women with PCOS', '38 PCOS patients who had undergone in vitro maturation (IVM) treatment', '828 immature oocytes were collected from 42 cycles and randomly assigned for insemination by IVF (416 oocytes) or ICSI (412 oocytes', 'patients with polycystic ovary syndrome (PCOS']",['conventional insemination (in vitro fertilization [IVF]) and intracytoplasmic sperm injection (ICSI'],"['fertilization rate', 'maturation rate', 'fertilization, developmental competence, implantation potential, and clinical pregnancy rate of embryos', 'fertilization, blastocyst formation, implantation rate, and clinical pregnancy', 'formation of good-quality blastocysts']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205252', 'cui_str': 'Immature'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0021586', 'cui_str': 'Insemination'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021586', 'cui_str': 'Insemination'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}]","[{'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C1281743', 'cui_str': 'Blastocyst structure'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",38.0,0.185798,"There was a comparable yield of in vitro matured oocytes derived from PCOS patients in terms of fertilization, blastocyst formation, implantation rate, and clinical pregnancy between IVF and ICSI insemination.","[{'ForeName': 'Pallop', 'Initials': 'P', 'LastName': 'Pongsuthirak', 'Affiliation': 'Department of Obstetrics and Gynecology, Buddhachinaraj Hospital Medical School, Phitsanulok, Thailand.'}]",Clinical and experimental reproductive medicine,['10.5653/cerm.2019.03300']
618,32404056,Effectiveness of concomitant use of green tea and polyethylene glycol in bowel preparation for colonoscopy: a randomized controlled study.,"BACKGROUND


Polyethylene glycol solution (PEG) is widely used for bowel preparation prior to colonoscopies. However, patients often exhibited adverse events as nausea, vomit and distention due to its uncomfortable tastes and potential side affects. This study aimed to evaluate the effectiveness and safety of concomitant use of green tea (GT) with PEG in bowel preparation prior to colonoscopy.
METHODS


This was a prospective, randomized controlled study. It was conducted at an outpatient setting of colorectal surgery in a tertiary hospital. Patients aged 18 through 80 who were scheduled to undergo colonoscopy between August 2015 and February 2016 were randomly assigned into two groups, admitting either 2 L-PEG solutions with 1 L GT liquids or 2 L-PEG solutions only for bowel preparation. Admitted doses of PEG solutions, taste evaluation, adverse reactions (nausea and vomiting, distention and abdominal pain) were investigated by questionnaires. The bowel cleanliness of each patient was evaluated according to the Aronchick indicators.
RESULTS


A total of 116 patients were enrolled in this study (PEG+GT 59, PEG 57). Full compliances were achieved in 93.2% patients of group PEG+GT and 59.6% of group PEG (p < 0.001). Mean Aronchick scale between two groups were 2.0 ± 0.9 versus 2.2 ± 0.7 respectively (PEG+GT vs PEG, p = 0.296). Rates of adverse events as nausea and vomiting, abdominal pain in bowel preparation were significantly different between two groups (55.9% vs 77.2%, p = 0.015 and 13.6% vs 33.3%, p = 0.012). Patients in group PEG+GT who have probabilities to receive repeating colonoscopy had a higher willingness to accept PEG+GT again for bowel preparation, compared with PEG group (94.9% vs 57.9%, p < 0.001).
CONCLUSIONS


Concomitant use of green tea and polyethylene glycol may effectively reduce incidence of adverse events, increase compliances, with comparable bowel cleanliness in bowel preparation.
TRIAL REGISTRATION


This trial was retrospectively registered on Feb 1st, 2019 (ChiCTR1900021178).",2020,"Patients in group PEG+GT who have probabilities to receive repeating colonoscopy had a higher willingness to accept PEG+GT again for bowel preparation, compared with PEG group (94.9% vs 57.9%, p < 0.001).
","['colonoscopy', 'Patients aged 18 through 80 who were scheduled to undergo colonoscopy between August 2015 and February 2016', '116 patients were enrolled in this study (PEG+GT 59, PEG 57']","['Polyethylene glycol solution (PEG', 'admitting either 2\u2009L-PEG solutions with 1\u2009L GT liquids or 2\u2009L-PEG solutions only for bowel preparation', 'green tea (GT) with PEG', 'green tea and polyethylene glycol']","['Full compliances', 'Mean Aronchick scale', 'nausea, vomit and distention', 'Rates of adverse events as nausea and vomiting, abdominal pain in bowel preparation', 'taste evaluation, adverse reactions (nausea and vomiting, distention and abdominal pain']","[{'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",116.0,0.083535,"Patients in group PEG+GT who have probabilities to receive repeating colonoscopy had a higher willingness to accept PEG+GT again for bowel preparation, compared with PEG group (94.9% vs 57.9%, p < 0.001).
","[{'ForeName': 'Zong', 'Initials': 'Z', 'LastName': 'Hao', 'Affiliation': ""Department of General Surgery, The Fifth People's Hospital of Shanghai, Fudan University, Shanghai, 200240, China.""}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Gong', 'Affiliation': ""Department of General Surgery, The Fifth People's Hospital of Shanghai, Fudan University, Shanghai, 200240, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Shen', 'Affiliation': ""Department of Endoscopic Center, The Fifth People's Hospital of Shanghai, Fudan University, Shanghai, 200240, China.""}, {'ForeName': 'Huipeng', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of General Surgery, The Fifth People's Hospital of Shanghai, Fudan University, Shanghai, 200240, China.""}, {'ForeName': 'Shaowen', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': ""Department of General Surgery, The Fifth People's Hospital of Shanghai, Fudan University, Shanghai, 200240, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of General Surgery, The Fifth People's Hospital of Shanghai, Fudan University, Shanghai, 200240, China.""}, {'ForeName': 'Yuankun', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': ""Department of General Surgery, The Fifth People's Hospital of Shanghai, Fudan University, Shanghai, 200240, China. 18918168583@163.com.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Colorectal Surgery, Peking University International Hospital, Beijing, 102206, China. chenjun@pkuih.edu.cn.'}]",BMC gastroenterology,['10.1186/s12876-020-01220-3']
619,32404059,Effectiveness of a community program for older adults with type 2 diabetes and multimorbidity: a pragmatic randomized controlled trial.,"BACKGROUND


Type II diabetes mellitus (T2DM) affects upwards of 25% of Canadian older adults and is associated with high comorbidity and burden. Studies show that lifestyle factors and self-management are associated with improved health outcomes, but many studies lack rigour or exclude older adults, particularly those with multimorbidity. More evidence is needed on the effectiveness of community-based self-management programs in older adults with T2DM and multimorbidity. The study purpose is to evaluate the effect of a community-based intervention versus usual care on physical functioning, mental health, depressive symptoms, anxiety, self-efficacy, self-management, and healthcare costs in older adults with T2DM and 2 or more comorbidities.
METHODS


Community-living older adults with T2DM and two or more chronic conditions were recruited from three Primary Care Networks (PCNs) in Alberta, Canada. Participants were randomly allocated to the intervention or control group in this pragmatic randomized controlled trial comparing the intervention to usual care. The intervention involved up to three in-home visits, a monthly group wellness program, monthly case conferencing, and care coordination. The primary outcome was physical functioning. Secondary outcomes included mental functioning, anxiety, depressive symptoms, self-efficacy, self-management, and the cost of healthcare service use. Intention-to-treat analysis was performed using ANCOVA modeling.
RESULTS


Of 132 enrolled participants (70-Intervention, 62-Control), 42% were 75 years or older, 55% were female, and over 75% had at least six chronic conditions (in addition to T2DM). No significant group differences were seen for the baseline to six-month change in physical functioning (mean difference: -0.74; 95% CI: - 3.22, 1.74; p-value: 0.56), mental functioning (mean difference: 1.24; 95% CI: - 1.12, 3.60; p-value: 0.30), or other secondary outcomes..
CONCLUSION


No significant group differences were seen for the primary outcome, physical functioning (PCS). Program implementation, baseline differences between study arms and chronic disease management services that are part of usual care may have contributed to the modest study results. Fruitful areas for future research include capturing clinical outcome measures and exploring the impact of varying the type and intensity of key intervention components such as exercise and diet.
TRIAL REGISTRATION


NCT02158741 Date of registration: June 9, 2014.",2020,"No significant group differences were seen for the baseline to six-month change in physical functioning (mean difference: -0.74; 95% CI: - 3.22, 1.74; p-value: 0.56), mental functioning (mean difference: 1.24; 95% CI: - 1.12, 3.60; p-value: 0.30), or other secondary outcomes..
CONCLUSION


","['older adults with T2DM and multimorbidity', 'older adults with T2DM and 2 or more comorbidities', 'Type II diabetes mellitus (T2DM) affects upwards of 25% of Canadian older adults', 'Community-living older adults with T2DM and two or more chronic conditions were recruited from three Primary Care Networks (PCNs) in Alberta, Canada', '132 enrolled participants (70-Intervention, 62-Control', 'older adults with type 2 diabetes and multimorbidity', ' 42% were 75\u2009years or older, 55% were female, and over 75% had at least six chronic conditions (in addition to T2DM']","['community program', 'community-based intervention versus usual care']","['mental functioning, anxiety, depressive symptoms, self-efficacy, self-management, and the cost of healthcare service use', 'physical functioning, mental health, depressive symptoms, anxiety, self-efficacy, self-management, and healthcare costs', 'physical functioning (PCS', 'mental functioning', 'physical functioning']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0557143', 'cui_str': 'Lives in a community'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0557829', 'cui_str': 'Healthcare services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}]",132.0,0.11465,"No significant group differences were seen for the baseline to six-month change in physical functioning (mean difference: -0.74; 95% CI: - 3.22, 1.74; p-value: 0.56), mental functioning (mean difference: 1.24; 95% CI: - 1.12, 3.60; p-value: 0.30), or other secondary outcomes..
CONCLUSION


","[{'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Miklavcic', 'Affiliation': 'Schmid College of Science and Technology, Chapman University, Orange, California, 92866, USA.'}, {'ForeName': 'Kimberly D', 'Initials': 'KD', 'LastName': 'Fraser', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, Alberta, T6G2R3, Canada.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ploeg', 'Affiliation': 'School of Nursing, and Scientific Director, Aging, Community and Health Research Unit, School of Nursing McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada. ploegj@mcmaster.ca.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Markle-Reid', 'Affiliation': 'Aging, Community and Health Research Unit, School of Nursing, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Fisher', 'Affiliation': 'Aging, Community and Health Research Unit, School of Nursing, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Amiram', 'Initials': 'A', 'LastName': 'Gafni', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact; and Centre for Health Economics and Policy Analysis, McMaster University, Hamilton, Ontario, L8S 4K1, Canada.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Griffith', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Hirst', 'Affiliation': 'Faculty of Nursing, University of Calgary, Calgary, Alberta, T2N 1N4, Canada.'}, {'ForeName': 'Cheryl A', 'Initials': 'CA', 'LastName': 'Sadowski', 'Affiliation': 'Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, 3-171 Edmonton Clinic Health Academy, Edmonton, Alberta, T6G 1C9, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, L8S 4K1, Canada.'}, {'ForeName': 'Jean A C', 'Initials': 'JAC', 'LastName': 'Triscott', 'Affiliation': 'Care of the Elderly Division, Glenrose Rehabilitation Hospital, Rm 1244 10230-111 Avenue, Edmonton, Alberta, T5G 0B7, Canada.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Upshur', 'Affiliation': 'Division of Clinical Public Health, Dalla Lana School of Public Health, University of Toronto, Room 678 155 College Street, Toronto, Ontario, M5T 3M7, Canada.'}]",BMC geriatrics,['10.1186/s12877-020-01557-0']
620,32404076,The effects of gamification on antimicrobial resistance knowledge and its relationship to dentistry in Saudi Arabia: a randomized controlled trial.,"BACKGROUND


Antimicrobial resistance (AMR) has reached alarming levels and is considered to be a worldwide public health problem. One of the most significant factors contributing to the spread of AMR is the lack of proper knowledge about the use of antibiotics, which are being used more frequently in dentistry. Recent studies have found that gamification shows promising results for helping the average person improve their knowledge about health and may also be used to boost knowledge about AMR among the public. This study aimed to assess the effects of gamification on AMR awareness, using a board game to promote knowledge about AMR among the public in Saudi Arabia.
METHODS


Using a single-blinded parallel group randomized controlled trial design, 94 volunteers were recruited and randomized into two groups. The study group received information about AMR by playing a board game, while the control group received the same information given in a conventional lecture. The participants were evaluated three times: (T1) before the intervention, (T2) immediately after the intervention, and (T3) one month after the intervention for follow-up to evaluate their retention of the information.
RESULTS


Results showed that there were significant improvements (p <  0.05) in knowledge scores for T2 and T3 in comparison to the T1 baseline scores in both groups. However, the knowledge scores also relapsed significantly from T2 to T3 in both groups. Nevertheless, the difference in knowledge score T1 to T3 was significantly higher in the study group in comparison to the control group, and the participants had higher mean scores to use the game as health promotion method.
CONCLUSIONS


Gamification using a board game can significantly improve AMR knowledge, with better retention than conventional lecture. It is a promising method for boosting public knowledge about AMR and its relationship to dentistry.
TRIAL REGISTRATION


ISRCTN registry: ISRCTN15884410 (retrospectively registered 26-October-2019).",2020,"RESULTS


Results showed that there were significant improvements (p <  0.05) in knowledge scores for T2 and T3 in comparison to the T1 baseline scores in both groups.","['Saudi Arabia', '94 volunteers']","['information about AMR by playing a board game, while the control group received the same information given in a conventional lecture']","['knowledge score T1 to T3', 'knowledge scores', 'AMR knowledge']","[{'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",94.0,0.0755879,"RESULTS


Results showed that there were significant improvements (p <  0.05) in knowledge scores for T2 and T3 in comparison to the T1 baseline scores in both groups.","[{'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Aboalshamat', 'Affiliation': 'Dental Public Health Division, Preventative Dentistry Department, College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia. ktaboalshamat@uqu.edu.sa.'}, {'ForeName': 'Amjad', 'Initials': 'A', 'LastName': 'Khayat', 'Affiliation': 'College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}, {'ForeName': 'Ragheb', 'Initials': 'R', 'LastName': 'Halwani', 'Affiliation': 'College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}, {'ForeName': 'Ammar', 'Initials': 'A', 'LastName': 'Bitan', 'Affiliation': 'College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}, {'ForeName': 'Ryyan', 'Initials': 'R', 'LastName': 'Alansari', 'Affiliation': 'College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}]",BMC public health,['10.1186/s12889-020-08806-2']
621,32404088,"The effect of health education on knowledge and behavior toward respiratory infectious diseases among students in Gansu, China: a quasi-natural experiment.","BACKGROUND


The respiratory infectious diseases (RID) threaten the health and life quality of school students. However, previous related studies were insufficient in research design and method applied. This study aimed to evaluate the effect of health education on the knowledge and behavior of students toward RID through difference-in-difference (DID) analysis in Gansu, China.
METHODS


In 2015-2016, a one-year health education program in Gansu, China was conducted. The intervention group contained 1064 students before and 1001 students after the health education (2015 and 2016, respectively). The control group contained 1018 and 1001 students, respectively. The health education, including playing promotional cartoons, developing lectures, giving out handbook copies and making hand copy and blackboard newspapers, and publicity columns on RID, were conducted monthly from 2015 to 2016 in intervention group. The data were collected before and after the health education program with a questionnaire on the students' knowledge and preventive behaviors regarding RID. The × 2  and t tests were performed to compare the accuracy rate and scores for RID knowledge and behavior of the two groups. DID estimation was conducted to evaluate the effect of health education on RID knowledge and behavior while controlling the non- equilibrium variables.
RESULTS


After the health education program, the accuracy rate and scores of most items in the intervention group were significantly higher than those in the control group (P < 0.05) except for item k9 ""What methods can prevent flu?"". The DID results wherein the demographics- age, nationality, and household register were controlled showed that health education significantly improved the accuracy rate of RID knowledge by 5.2-63.9% for most items, although the accuracy rates of items k2 ""What's the transmission way of the mumps?"" and k9 were significantly decreased by 36.8 and 12.0%. The health education significantly improved the score of knowledge by 155.2% (P < 0.001) and the accuracy rate of all items of RID behavior by 2.9-51.5% except for item b3 ""If you have phlegm, how do you usually deal with it?"". In addition, the health education also significantly improved the score of behavior toward RID of the sampled students by 138.2% (P < 0.001).
CONCLUSION


The results of this study show that health education seemed to increase the RID knowledge and behavior of students. It is recommended that the health education should be enhanced and popularized in schools of China, and RID transmission routes and prevention methods should attract more attention.",2020,"The health education significantly improved the score of knowledge by 155.2% (P < 0.001) and the accuracy rate of all items of RID behavior by 2.9-51.5% except for item b3 ""If you have phlegm, how do you usually deal with it?"".","['students in Gansu, China', '1064 students before and 1001 students after the health education (2015 and 2016, respectively', 'In 2015-2016, a one-year health education program in Gansu, China was conducted', 'school students']",['health education'],"['score of knowledge', 'accuracy rate and scores of most items', 'score of behavior toward RID', 'accuracy rate of all items of RID behavior', 'accuracy rate and scores for RID knowledge and behavior', 'accuracy rate of RID knowledge', 'knowledge and behavior toward respiratory infectious diseases', 'RID knowledge and behavior of students']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",,0.0225614,"The health education significantly improved the score of knowledge by 155.2% (P < 0.001) and the accuracy rate of all items of RID behavior by 2.9-51.5% except for item b3 ""If you have phlegm, how do you usually deal with it?"".","[{'ForeName': 'Manli', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'China Center for Special Economic Zone Research, Shenzhen University, Shenzhen, 518060, China.'}, {'ForeName': 'Haiqing', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': ""Administration Office, Shenzhen People's Hospital, Second Clinical Medical College of Jinan University, First Affiliated Hospital of Southern University of Science and Technology, Shenzhen, 518020, China. fanghq@szhospital.com.""}]",BMC public health,['10.1186/s12889-020-08813-3']
622,32404343,Adalimumab dose tapering in patients with rheumatoid arthritis who are in long-standing clinical remission: results of the phase IV PREDICTRA study.,"OBJECTIVE


To investigate the association between baseline disease activity and the occurrence of flares after adalimumab tapering or withdrawal in patients with rheumatoid arthritis (RA) in sustained remission.
METHODS


The PREDICTRA phase IV, randomised, double-blind (DB) study (Im P act of  R esidual Inflammation Detected via Imaging T E chniques,  D rug Levels, and Patient Characteristics on the Outcome of Dose Taper I ng of Adalimumab in  C linical Remission Rheumatoid Ar T hritis ( RA ) Patients) enrolled patients with RA receiving adalimumab 40 mg every other week who were in sustained remission ≥6 months. After a 4-week, open-label lead-in (OL-LI) period, patients were randomised 5:1 to DB adalimumab taper (every 3 weeks) or withdrawal (placebo) for 36 weeks. The primary endpoint was the association between DB baseline hand and wrist MRI-detected inflammation with flare occurrence.
RESULTS


Of 146 patients treated during the OL-LI period, 122 were randomised to taper (n=102) or withdrawal (n=20) arms. Patients had a mean 12.9 years of active disease and had received adalimumab for a mean of 5.4 years (mean 2.2 years in sustained remission). Overall, 37 (36%) and 9 (45%) patients experienced a flare in the taper and withdrawal arms, respectively (time to flare, 18.0 and 13.3 weeks). None of the DB baseline disease characteristics or adalimumab concentration was associated with flare occurrence after adalimumab tapering. Approximately half of the patients who flared regained clinical remission after 16 weeks of open-label rescue adalimumab. The safety profile was consistent with previous studies.
CONCLUSIONS


Approximately one-third of patients who tapered adalimumab versus half who withdrew adalimumab experienced a flare within 36 weeks. Time to flare was numerically longer in the taper versus withdrawal arm. Baseline MRI inflammation was not associated with flare occurrence.
TRIAL REGISTRATION NUMBER


NCT02198651, EudraCT 2014-001114-26.",2020,None of the DB baseline disease characteristics or adalimumab concentration was associated with flare occurrence after adalimumab tapering.,"['patients with rheumatoid arthritis (RA) in sustained remission', 'Patients had a mean 12.9 years of active disease and had received adalimumab for a mean of 5.4 years (mean 2.2 years in sustained remission', 'C linical Remission Rheumatoid Ar T hritis ( RA ) Patients) enrolled patients with RA receiving adalimumab 40\u2009mg every other week who were in sustained remission ≥6 months', '146 patients treated during the OL-LI period, 122 were randomised to taper (n=102) or withdrawal (n=20) arms', 'patients with rheumatoid arthritis who are in long-standing clinical remission']","['DB adalimumab taper (every 3 weeks) or withdrawal (placebo', 'adalimumab tapering or withdrawal', 'Adalimumab', 'tapered adalimumab']","['association between DB baseline hand and wrist MRI-detected inflammation with flare occurrence', 'Baseline MRI inflammation', 'DB baseline disease characteristics or adalimumab concentration', 'clinical remission', 'Time to flare']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0412709', 'cui_str': 'MRI of wrist'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.196623,None of the DB baseline disease characteristics or adalimumab concentration was associated with flare occurrence after adalimumab tapering.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK p.emery@leeds.ac.uk.'}, {'ForeName': 'Gerd R', 'Initials': 'GR', 'LastName': 'Burmester', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Naredo', 'Affiliation': 'Department of Rheumatology, Joint and Bone Research Unit, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Sinigaglia', 'Affiliation': 'Department of Rheumatology and Medical Sciences, Centro Specialistico Ortopedico Traumatologico Pini-CTO, Milan, Italy.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Lagunes', 'Affiliation': 'Global Medical Affairs Rheumatology, AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Koenigsbauer', 'Affiliation': 'Data and Statistical Sciences, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.'}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217246']
623,32404353,Costimulation Blockade Disrupts CD4 +  T Cell Memory Pathways and Uncouples Their Link to Decline in β-Cell Function in Type 1 Diabetes.,"We previously reported that costimulation blockade by abatacept limits the decline of β-cell function and the frequency of circulating CD4 +  central memory T cells (T CM ) (CD45RO + CD62L + ) in new-onset type 1 diabetes. In human subjects receiving placebo, we found a significant association between an increase in CD4 +  T CM  cells and the decline of β-cell function. To extend and refine these findings, we examined changes in human CD4 +  and CD8 +  naive and memory T cell subsets at greater resolution using polychromatic flow and mass cytometry. In the placebo group, we successfully reproduced the original finding of a significant association between T CM  and β-cell function and extended this to other T cell subsets. Furthermore, we show that abatacept treatment significantly alters the frequencies of a majority of CD4 +  conventional and regulatory T cell subsets; in general, Ag-naive subsets increase and Ag-experienced subsets decrease, whereas CD8 +  T cell subsets are relatively resistant to drug effects, indicating a lesser reliance on CD28-mediated costimulation. Importantly, abatacept uncouples the relationship between changes in T cell subsets and β-cell function that is a component of the natural history of the disease. Although these data suggest immunological markers for predicting change in β-cell function in type 1 diabetes, the finding that abatacept blunts this relationship renders the biomarkers nonpredictive for this type of therapy. In sum, our findings point to a novel mechanism of action for this successful immunotherapy that may guide other disease-modifying approaches for type 1 diabetes.",2020,"In the placebo group, we successfully reproduced the original finding of a significant association between T CM  and β-cell function and extended this to other T cell subsets.",[],['placebo'],"['T CM  and β-cell function', 'CD4 +  T CM  cells and the decline of β-cell function', 'human CD4 +  and CD8 +  naive and memory T cell subsets', 'frequencies of a majority of CD4 +  conventional and regulatory T cell subsets', 'frequency of circulating CD4 +  central memory T cells (T CM ) (CD45RO + CD62L + ']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0080202', 'cui_str': 'T-Cell Subsets'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0162833', 'cui_str': 'Lymphocyte antigen CD45RO'}, {'cui': 'C0125090', 'cui_str': 'Lymphocyte antigen CD62L'}]",,0.0502345,"In the placebo group, we successfully reproduced the original finding of a significant association between T CM  and β-cell function and extended this to other T cell subsets.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Eichmann', 'Affiliation': ""Peter Gorer Department of Immunobiology, Faculty of Life Sciences and Medicine, King's College London, London SE1 9RT, United Kingdom; martin.eichmann@kcl.ac.uk.""}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Baptista', 'Affiliation': ""Peter Gorer Department of Immunobiology, Faculty of Life Sciences and Medicine, King's College London, London SE1 9RT, United Kingdom.""}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Ellis', 'Affiliation': ""Biomedical Research Centre at Guy's and St Thomas' Hospitals and King's College London, London SE1 9RT, United Kingdom.""}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Heck', 'Affiliation': ""Biomedical Research Centre at Guy's and St Thomas' Hospitals and King's College London, London SE1 9RT, United Kingdom.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Peakman', 'Affiliation': ""Peter Gorer Department of Immunobiology, Faculty of Life Sciences and Medicine, King's College London, London SE1 9RT, United Kingdom.""}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Beam', 'Affiliation': 'Department of Biomedical Sciences, Homer Stryker M.D. School of Medicine, Western Michigan University, Kalamazoo, MI 49008.'}]","Journal of immunology (Baltimore, Md. : 1950)",['10.4049/jimmunol.1901439']
624,32404355,Aerobic exercise improves cognition and cerebrovascular regulation in older adults.,"OBJECTIVE


To test the hypothesis that aerobic exercise is associated with improvements in cognition and cerebrovascular regulation, we enrolled 206 healthy low-active middle-aged and older adults (mean ± SD age 65.9 ± 6.4 years) in a supervised 6-month aerobic exercise intervention and assessed them before and after the intervention.
METHODS


The study is a quasi-experimental single group pre/postintervention study. Neuropsychological tests were used to assess cognition before and after the intervention. Transcranial Doppler ultrasound was used to measure cerebral blood flow velocity. Cerebrovascular regulation was assessed at rest, during euoxic hypercapnia, and in response to submaximal exercise. Multiple linear regression was used to examine the association between changes in cognition and changes in cerebrovascular function.
RESULTS


The intervention was associated with improvements in some cognitive domains, cardiorespiratory fitness, and cerebrovascular regulation. Changes in executive functions were negatively associated with changes in cerebrovascular resistance index (CVRi) during submaximal exercise (β = -0.205,  p  = 0.013), while fluency improvements were positively associated with changes in CVRi during hypercapnia (β = 0.106,  p =  0.03).
CONCLUSION


The 6-month aerobic exercise intervention was associated with improvements in some cognitive domains and cerebrovascular regulation. Secondary analyses showed a novel association between changes in cognition and changes in cerebrovascular regulation during euoxic hypercapnia and in response to submaximal exercise.",2020,"Changes in executive functions were negatively associated with changes in cerebrovascular resistance index (CVRi) during submaximal exercise (β = -0.205,  p  = 0.013), while fluency improvements were positively associated with changes in CVRi during hypercapnia (β = 0.106,  p =  0.03).
","['older adults', '206 healthy low-active middle-aged and older adults (mean ± SD age 65.9 ± 6.4 years) in a']","['aerobic exercise intervention', 'Transcranial Doppler ultrasound', 'Aerobic exercise', 'supervised 6-month aerobic exercise intervention', 'aerobic exercise']","['Cerebrovascular regulation', 'executive functions', 'some cognitive domains and cerebrovascular regulation', 'cognition and cerebrovascular regulation', 'cerebral blood flow velocity', 'cognition and changes in cerebrovascular regulation', 'cerebrovascular resistance index (CVRi', 'some cognitive domains, cardiorespiratory fitness, and cerebrovascular regulation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0206077', 'cui_str': 'Transcranial doppler ultrasonography'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",206.0,0.0187172,"Changes in executive functions were negatively associated with changes in cerebrovascular resistance index (CVRi) during submaximal exercise (β = -0.205,  p  = 0.013), while fluency improvements were positively associated with changes in CVRi during hypercapnia (β = 0.106,  p =  0.03).
","[{'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Guadagni', 'Affiliation': ""From the Department of Physiology and Pharmacology (V.G., L.L.D., A.V.T., G.A.E., M.J.P.), Hotchkiss Brain Institute (V.G., L.L.D., A.V.T., R.S.L., M.D.H., D.B.H., M.J.P.), Division of Geriatric Medicine (D.B.H.), Department of Medicine, Department of Clinical Neurosciences (V.G., L.L.D., A.V.T., M.D.H., D.B.H., M.J.P.), Libin Cardiovascular Institute of Alberta (T.J.A., M.J.P.), O'Brien Institute for Public Health (V.G., D.B.H., M.J.P.), Department of Cardiac Sciences (T.J.A.), Libin Cardiovascular Institute of Alberta, and Department of Community Health Sciences (M.D.H.), Cumming School of Medicine, Faculty of Kinesiology (M.J.P.), and Department of Psychology (R.S.L.), University of Calgary; Psychology Service (R.S.L.), Alberta Health Service, Foothills Medical Centre, Calgary; Department of Psychiatry (G.A.E.), Faculty of Medicine, and Department of Psychology and Neuroscience (G.A.E.), Faculty of Science, Dalhousie University, Halifax, Nova Scotia; and Program for Pregnancy and Postpartum Health, Physical Activity and Diabetes Laboratory (M.H.D.), Faculty of Kinesiology, Sport, and Recreation, Women and Children's Health Research Institute, Alberta Diabetes Institute, University of Alberta, Edmonton, Canada.""}, {'ForeName': 'Lauren L', 'Initials': 'LL', 'LastName': 'Drogos', 'Affiliation': ""From the Department of Physiology and Pharmacology (V.G., L.L.D., A.V.T., G.A.E., M.J.P.), Hotchkiss Brain Institute (V.G., L.L.D., A.V.T., R.S.L., M.D.H., D.B.H., M.J.P.), Division of Geriatric Medicine (D.B.H.), Department of Medicine, Department of Clinical Neurosciences (V.G., L.L.D., A.V.T., M.D.H., D.B.H., M.J.P.), Libin Cardiovascular Institute of Alberta (T.J.A., M.J.P.), O'Brien Institute for Public Health (V.G., D.B.H., M.J.P.), Department of Cardiac Sciences (T.J.A.), Libin Cardiovascular Institute of Alberta, and Department of Community Health Sciences (M.D.H.), Cumming School of Medicine, Faculty of Kinesiology (M.J.P.), and Department of Psychology (R.S.L.), University of Calgary; Psychology Service (R.S.L.), Alberta Health Service, Foothills Medical Centre, Calgary; Department of Psychiatry (G.A.E.), Faculty of Medicine, and Department of Psychology and Neuroscience (G.A.E.), Faculty of Science, Dalhousie University, Halifax, Nova Scotia; and Program for Pregnancy and Postpartum Health, Physical Activity and Diabetes Laboratory (M.H.D.), Faculty of Kinesiology, Sport, and Recreation, Women and Children's Health Research Institute, Alberta Diabetes Institute, University of Alberta, Edmonton, Canada.""}, {'ForeName': 'Amanda V', 'Initials': 'AV', 'LastName': 'Tyndall', 'Affiliation': ""From the Department of Physiology and Pharmacology (V.G., L.L.D., A.V.T., G.A.E., M.J.P.), Hotchkiss Brain Institute (V.G., L.L.D., A.V.T., R.S.L., M.D.H., D.B.H., M.J.P.), Division of Geriatric Medicine (D.B.H.), Department of Medicine, Department of Clinical Neurosciences (V.G., L.L.D., A.V.T., M.D.H., D.B.H., M.J.P.), Libin Cardiovascular Institute of Alberta (T.J.A., M.J.P.), O'Brien Institute for Public Health (V.G., D.B.H., M.J.P.), Department of Cardiac Sciences (T.J.A.), Libin Cardiovascular Institute of Alberta, and Department of Community Health Sciences (M.D.H.), Cumming School of Medicine, Faculty of Kinesiology (M.J.P.), and Department of Psychology (R.S.L.), University of Calgary; Psychology Service (R.S.L.), Alberta Health Service, Foothills Medical Centre, Calgary; Department of Psychiatry (G.A.E.), Faculty of Medicine, and Department of Psychology and Neuroscience (G.A.E.), Faculty of Science, Dalhousie University, Halifax, Nova Scotia; and Program for Pregnancy and Postpartum Health, Physical Activity and Diabetes Laboratory (M.H.D.), Faculty of Kinesiology, Sport, and Recreation, Women and Children's Health Research Institute, Alberta Diabetes Institute, University of Alberta, Edmonton, Canada.""}, {'ForeName': 'Margie H', 'Initials': 'MH', 'LastName': 'Davenport', 'Affiliation': ""From the Department of Physiology and Pharmacology (V.G., L.L.D., A.V.T., G.A.E., M.J.P.), Hotchkiss Brain Institute (V.G., L.L.D., A.V.T., R.S.L., M.D.H., D.B.H., M.J.P.), Division of Geriatric Medicine (D.B.H.), Department of Medicine, Department of Clinical Neurosciences (V.G., L.L.D., A.V.T., M.D.H., D.B.H., M.J.P.), Libin Cardiovascular Institute of Alberta (T.J.A., M.J.P.), O'Brien Institute for Public Health (V.G., D.B.H., M.J.P.), Department of Cardiac Sciences (T.J.A.), Libin Cardiovascular Institute of Alberta, and Department of Community Health Sciences (M.D.H.), Cumming School of Medicine, Faculty of Kinesiology (M.J.P.), and Department of Psychology (R.S.L.), University of Calgary; Psychology Service (R.S.L.), Alberta Health Service, Foothills Medical Centre, Calgary; Department of Psychiatry (G.A.E.), Faculty of Medicine, and Department of Psychology and Neuroscience (G.A.E.), Faculty of Science, Dalhousie University, Halifax, Nova Scotia; and Program for Pregnancy and Postpartum Health, Physical Activity and Diabetes Laboratory (M.H.D.), Faculty of Kinesiology, Sport, and Recreation, Women and Children's Health Research Institute, Alberta Diabetes Institute, University of Alberta, Edmonton, Canada.""}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Anderson', 'Affiliation': ""From the Department of Physiology and Pharmacology (V.G., L.L.D., A.V.T., G.A.E., M.J.P.), Hotchkiss Brain Institute (V.G., L.L.D., A.V.T., R.S.L., M.D.H., D.B.H., M.J.P.), Division of Geriatric Medicine (D.B.H.), Department of Medicine, Department of Clinical Neurosciences (V.G., L.L.D., A.V.T., M.D.H., D.B.H., M.J.P.), Libin Cardiovascular Institute of Alberta (T.J.A., M.J.P.), O'Brien Institute for Public Health (V.G., D.B.H., M.J.P.), Department of Cardiac Sciences (T.J.A.), Libin Cardiovascular Institute of Alberta, and Department of Community Health Sciences (M.D.H.), Cumming School of Medicine, Faculty of Kinesiology (M.J.P.), and Department of Psychology (R.S.L.), University of Calgary; Psychology Service (R.S.L.), Alberta Health Service, Foothills Medical Centre, Calgary; Department of Psychiatry (G.A.E.), Faculty of Medicine, and Department of Psychology and Neuroscience (G.A.E.), Faculty of Science, Dalhousie University, Halifax, Nova Scotia; and Program for Pregnancy and Postpartum Health, Physical Activity and Diabetes Laboratory (M.H.D.), Faculty of Kinesiology, Sport, and Recreation, Women and Children's Health Research Institute, Alberta Diabetes Institute, University of Alberta, Edmonton, Canada.""}, {'ForeName': 'Gail A', 'Initials': 'GA', 'LastName': 'Eskes', 'Affiliation': ""From the Department of Physiology and Pharmacology (V.G., L.L.D., A.V.T., G.A.E., M.J.P.), Hotchkiss Brain Institute (V.G., L.L.D., A.V.T., R.S.L., M.D.H., D.B.H., M.J.P.), Division of Geriatric Medicine (D.B.H.), Department of Medicine, Department of Clinical Neurosciences (V.G., L.L.D., A.V.T., M.D.H., D.B.H., M.J.P.), Libin Cardiovascular Institute of Alberta (T.J.A., M.J.P.), O'Brien Institute for Public Health (V.G., D.B.H., M.J.P.), Department of Cardiac Sciences (T.J.A.), Libin Cardiovascular Institute of Alberta, and Department of Community Health Sciences (M.D.H.), Cumming School of Medicine, Faculty of Kinesiology (M.J.P.), and Department of Psychology (R.S.L.), University of Calgary; Psychology Service (R.S.L.), Alberta Health Service, Foothills Medical Centre, Calgary; Department of Psychiatry (G.A.E.), Faculty of Medicine, and Department of Psychology and Neuroscience (G.A.E.), Faculty of Science, Dalhousie University, Halifax, Nova Scotia; and Program for Pregnancy and Postpartum Health, Physical Activity and Diabetes Laboratory (M.H.D.), Faculty of Kinesiology, Sport, and Recreation, Women and Children's Health Research Institute, Alberta Diabetes Institute, University of Alberta, Edmonton, Canada.""}, {'ForeName': 'R Stewart', 'Initials': 'RS', 'LastName': 'Longman', 'Affiliation': ""From the Department of Physiology and Pharmacology (V.G., L.L.D., A.V.T., G.A.E., M.J.P.), Hotchkiss Brain Institute (V.G., L.L.D., A.V.T., R.S.L., M.D.H., D.B.H., M.J.P.), Division of Geriatric Medicine (D.B.H.), Department of Medicine, Department of Clinical Neurosciences (V.G., L.L.D., A.V.T., M.D.H., D.B.H., M.J.P.), Libin Cardiovascular Institute of Alberta (T.J.A., M.J.P.), O'Brien Institute for Public Health (V.G., D.B.H., M.J.P.), Department of Cardiac Sciences (T.J.A.), Libin Cardiovascular Institute of Alberta, and Department of Community Health Sciences (M.D.H.), Cumming School of Medicine, Faculty of Kinesiology (M.J.P.), and Department of Psychology (R.S.L.), University of Calgary; Psychology Service (R.S.L.), Alberta Health Service, Foothills Medical Centre, Calgary; Department of Psychiatry (G.A.E.), Faculty of Medicine, and Department of Psychology and Neuroscience (G.A.E.), Faculty of Science, Dalhousie University, Halifax, Nova Scotia; and Program for Pregnancy and Postpartum Health, Physical Activity and Diabetes Laboratory (M.H.D.), Faculty of Kinesiology, Sport, and Recreation, Women and Children's Health Research Institute, Alberta Diabetes Institute, University of Alberta, Edmonton, Canada.""}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hill', 'Affiliation': ""From the Department of Physiology and Pharmacology (V.G., L.L.D., A.V.T., G.A.E., M.J.P.), Hotchkiss Brain Institute (V.G., L.L.D., A.V.T., R.S.L., M.D.H., D.B.H., M.J.P.), Division of Geriatric Medicine (D.B.H.), Department of Medicine, Department of Clinical Neurosciences (V.G., L.L.D., A.V.T., M.D.H., D.B.H., M.J.P.), Libin Cardiovascular Institute of Alberta (T.J.A., M.J.P.), O'Brien Institute for Public Health (V.G., D.B.H., M.J.P.), Department of Cardiac Sciences (T.J.A.), Libin Cardiovascular Institute of Alberta, and Department of Community Health Sciences (M.D.H.), Cumming School of Medicine, Faculty of Kinesiology (M.J.P.), and Department of Psychology (R.S.L.), University of Calgary; Psychology Service (R.S.L.), Alberta Health Service, Foothills Medical Centre, Calgary; Department of Psychiatry (G.A.E.), Faculty of Medicine, and Department of Psychology and Neuroscience (G.A.E.), Faculty of Science, Dalhousie University, Halifax, Nova Scotia; and Program for Pregnancy and Postpartum Health, Physical Activity and Diabetes Laboratory (M.H.D.), Faculty of Kinesiology, Sport, and Recreation, Women and Children's Health Research Institute, Alberta Diabetes Institute, University of Alberta, Edmonton, Canada.""}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Hogan', 'Affiliation': ""From the Department of Physiology and Pharmacology (V.G., L.L.D., A.V.T., G.A.E., M.J.P.), Hotchkiss Brain Institute (V.G., L.L.D., A.V.T., R.S.L., M.D.H., D.B.H., M.J.P.), Division of Geriatric Medicine (D.B.H.), Department of Medicine, Department of Clinical Neurosciences (V.G., L.L.D., A.V.T., M.D.H., D.B.H., M.J.P.), Libin Cardiovascular Institute of Alberta (T.J.A., M.J.P.), O'Brien Institute for Public Health (V.G., D.B.H., M.J.P.), Department of Cardiac Sciences (T.J.A.), Libin Cardiovascular Institute of Alberta, and Department of Community Health Sciences (M.D.H.), Cumming School of Medicine, Faculty of Kinesiology (M.J.P.), and Department of Psychology (R.S.L.), University of Calgary; Psychology Service (R.S.L.), Alberta Health Service, Foothills Medical Centre, Calgary; Department of Psychiatry (G.A.E.), Faculty of Medicine, and Department of Psychology and Neuroscience (G.A.E.), Faculty of Science, Dalhousie University, Halifax, Nova Scotia; and Program for Pregnancy and Postpartum Health, Physical Activity and Diabetes Laboratory (M.H.D.), Faculty of Kinesiology, Sport, and Recreation, Women and Children's Health Research Institute, Alberta Diabetes Institute, University of Alberta, Edmonton, Canada.""}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Poulin', 'Affiliation': ""From the Department of Physiology and Pharmacology (V.G., L.L.D., A.V.T., G.A.E., M.J.P.), Hotchkiss Brain Institute (V.G., L.L.D., A.V.T., R.S.L., M.D.H., D.B.H., M.J.P.), Division of Geriatric Medicine (D.B.H.), Department of Medicine, Department of Clinical Neurosciences (V.G., L.L.D., A.V.T., M.D.H., D.B.H., M.J.P.), Libin Cardiovascular Institute of Alberta (T.J.A., M.J.P.), O'Brien Institute for Public Health (V.G., D.B.H., M.J.P.), Department of Cardiac Sciences (T.J.A.), Libin Cardiovascular Institute of Alberta, and Department of Community Health Sciences (M.D.H.), Cumming School of Medicine, Faculty of Kinesiology (M.J.P.), and Department of Psychology (R.S.L.), University of Calgary; Psychology Service (R.S.L.), Alberta Health Service, Foothills Medical Centre, Calgary; Department of Psychiatry (G.A.E.), Faculty of Medicine, and Department of Psychology and Neuroscience (G.A.E.), Faculty of Science, Dalhousie University, Halifax, Nova Scotia; and Program for Pregnancy and Postpartum Health, Physical Activity and Diabetes Laboratory (M.H.D.), Faculty of Kinesiology, Sport, and Recreation, Women and Children's Health Research Institute, Alberta Diabetes Institute, University of Alberta, Edmonton, Canada. poulin@ucalgary.ca.""}]",Neurology,['10.1212/WNL.0000000000009478']
625,32404378,Effect of high-salt diet on blood pressure and body fluid composition in patients with type 1 diabetes: randomized controlled intervention trial.,"INTRODUCTION


Patients with type 1 diabetes are susceptible to hypertension, possibly resulting from increased salt sensitivity and accompanied changes in body fluid composition. We examined the effect of a high-salt diet (HSD) in type 1 diabetes on hemodynamics, including blood pressure (BP) and body fluid composition.
RESEARCH DESIGN AND METHODS


We studied eight male patients with type 1 diabetes and 12 matched healthy controls with normal BP, body mass index, and renal function. All subjects adhered to a low-salt diet and HSD for eight days in randomized order. On day 8 of each diet, extracellular fluid volume (ECFV) and plasma volume were calculated with the use of iohexol and  125 I-albumin distribution. Hemodynamic measurements included BP, cardiac output (CO), and systemic vascular resistance.
RESULTS


After HSD, patients with type 1 diabetes showed a BP increase (mean arterial pressure: 85 (5) mm Hg vs 80 (3) mm Hg; p<0.05), while BP in controls did not rise (78 (5) mm Hg vs 78 (5) mm Hg). Plasma volume increased after HSD in patients with type 1 diabetes (p<0.05) and not in controls (p=0.23). There was no significant difference in ECFV between diets, while HSD significantly increased CO, heart rate (HR) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) in type 1 diabetes but not in controls. There were no significant differences in systemic vascular resistance, although there was a trend towards an HSD-induced decrease in controls (p=0.09).
CONCLUSIONS


In the present study, patients with type 1 diabetes show a salt-sensitive BP rise to HSD, which is accompanied by significant increases in plasma volume, CO, HR, and NT-proBNP. Underlying mechanisms for these responses need further research in order to unravel the increased susceptibility to hypertension and cardiovascular disease in diabetes.
TRIAL REGISTRATION NUMBERS


NTR4095 and NTR4788.",2020,"There were no significant differences in systemic vascular resistance, although there was a trend towards an HSD-induced decrease in controls (p=0.09).
","['eight male patients with type 1 diabetes and 12 matched healthy controls with normal BP, body mass index, and renal function', 'patients with type 1 diabetes']","['high-salt diet', 'high-salt diet (HSD', 'iohexol']","['BP, cardiac output (CO), and systemic vascular resistance', 'BP increase (mean arterial pressure', 'plasma volume, CO, HR, and NT-proBNP', 'blood pressure and body fluid composition', 'systemic vascular resistance', 'ECFV', 'Plasma volume', 'blood pressure (BP) and body fluid composition', 'CO, heart rate (HR) and N-terminal pro-B-type natriuretic peptide (NT-proBNP', 'extracellular fluid volume (ECFV) and plasma volume']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0022005', 'cui_str': 'Iohexol'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0497247', 'cui_str': 'Elevated blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015349', 'cui_str': 'Extracellular fluid'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",8.0,0.034718,"There were no significant differences in systemic vascular resistance, although there was a trend towards an HSD-induced decrease in controls (p=0.09).
","[{'ForeName': 'Eliane F E', 'Initials': 'EFE', 'LastName': 'Wenstedt', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC - Locatie AMC, Amsterdam, North Holland, Netherlands.'}, {'ForeName': 'Nienke M G', 'Initials': 'NMG', 'LastName': 'Rorije', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC - Locatie AMC, Amsterdam, North Holland, Netherlands.'}, {'ForeName': 'Rik H G', 'Initials': 'RHG', 'LastName': 'Olde Engberink', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC - Locatie AMC, Amsterdam, North Holland, Netherlands.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'van der Molen', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC - Locatie AMC, Amsterdam, North Holland, Netherlands.'}, {'ForeName': 'Youssef', 'Initials': 'Y', 'LastName': 'Chahid', 'Affiliation': 'Department of Pharmacy, Amsterdam UMC - Locatie AMC, Amsterdam, North Holland, Netherlands.'}, {'ForeName': 'A H Jan', 'Initials': 'AHJ', 'LastName': 'Danser', 'Affiliation': 'Department of Internal Medicine, Erasmus MC, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'Bert-Jan H', 'Initials': 'BH', 'LastName': 'van den Born', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC - Locatie AMC, Amsterdam, North Holland, Netherlands.'}, {'ForeName': 'Liffert', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC - Locatie AMC, Amsterdam, North Holland, Netherlands l.vogt@amsterdamumc.nl.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-001039']
626,32404854,Clinical Value of Serum LHPP-associated miR-765 in the Prognosis of Laparoscopic or Open Hepatectomy for Hepatocellular Carcinoma.,"PURPOSE


The current study aims to investigate the effect of tumor suppressor LHPP-associated microRNA (miR)-765 on the prognosis of laparoscopic hepatectomy (LH) or open hepatectomy (OH) for hepatocellular carcinoma (HCC).
MATERIALS AND METHODS


A total of 160 patients with HCC were enrolled and randomly divided into the LH or OH group. According to the operation time, these patients were followed up for 12 months, and the number of deaths and the corresponding death time during the follow-up period were counted.
RESULTS


The authors found that the LHPP gene levels in HCC tissues were lower than that in adjacent normal tissues, whereas miR-765 was overexpressed in HCC tissue. Overexpression of miR-765 promoted the epithelial-mesenchymal transition and proliferation and inhibited apoptosis of HCC through directly downregulating LHPP expression. Serum miR-765 expression level was significantly associated with lymph node metastasis and histologic grading. Survival analysis showed that the overall survival rate in 12 months after the operation was significantly lower in the OH-high miR-765 group (P<0.05).
CONCLUSION


For patients with a low miR-765 level, both LH and OH are available, otherwise, LH is more recommended.",2020,"Survival analysis showed that the overall survival rate in 12 months after the operation was significantly lower in the OH-high miR-765 group (P<0.05).
","['Hepatocellular Carcinoma', '160 patients with HCC', 'hepatocellular carcinoma (HCC']","['laparoscopic hepatectomy (LH) or open hepatectomy (OH', 'LH or OH', 'tumor suppressor LHPP-associated microRNA (miR)-765']","['overall survival rate', 'Serum miR-765 expression level', 'LHPP gene levels in HCC tissues', 'number of deaths and the corresponding death time']","[{'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0079427', 'cui_str': 'Antioncogene'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1301931', 'cui_str': 'Time of death'}]",160.0,0.0345093,"Survival analysis showed that the overall survival rate in 12 months after the operation was significantly lower in the OH-high miR-765 group (P<0.05).
","[{'ForeName': 'Jingting', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Departments of Hepatobiliary Surgery.'}, {'ForeName': 'Liyan', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Hyperbaric Oxidation, NanHua Hospital.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, The First Affiliated Hospital, University of South China.'}, {'ForeName': 'Xiuda', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': ""Department of Urology, Hengyang Hospital, Southern Medical University, Hengyang City, Hunan Province, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Departments of Hepatobiliary Surgery.'}, {'ForeName': 'Xianrong', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Departments of Hepatobiliary Surgery.'}, {'ForeName': 'Dunxue', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Departments of Hepatobiliary Surgery.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Departments of Hepatobiliary Surgery.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Departments of Hepatobiliary Surgery.'}, {'ForeName': 'Xianzhou', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Departments of Hepatobiliary Surgery.'}]","Surgical laparoscopy, endoscopy & percutaneous techniques",['10.1097/SLE.0000000000000808']
627,32404897,Impact of interdental brush shape on interpapillary cleaning efficacy - a clinical trial.,"This study aimed to investigate whether interdental brush shape influences cleaning efficacy, by comparing a waist-shaped interdental brush (W-IDB) with a cylindrical IDB (C-IDB); both provided with the same bristle texture. Cleaning efficacy of differently shaped IDBs was measured in proximal surfaces of teeth in a split-mouth cross-over design. Twenty-eight patients abolished oral hygiene for 4 d. Line angle plaque area was scanned with an intraoral camera after use of disclosing dye in baseline and after IDB application and analyzed planimetrically. Additionally, bacterial load in the IDBs was analyzed after usage by colony forming units (cfu). A Wilcoxon signed-rank test with continuity correction was used to compare the results of the waist-shaped and the cylindrically-shaped IDBs. The waist-shaped IDBs cleaned significantly better than their cylindrically-shaped counterparts (area cleaned: 23.1% vs. 18.3%), when applied at same interdental spaces (p < 0.001). However, no significant differences were found in comparison of bacterial load on the IDBs (median cfu counts: 2.3E9 vs. 2.7E9, p = 0.93). Irrespective of bristle texture or size, IDB shape have impact on cleaning efficacy. Waist-shaped IDBs are more effective in cleaning of the line angle area than cylindrically-shaped IDBs.",2020,"The waist-shaped IDBs cleaned significantly better than their cylindrically-shaped counterparts (area cleaned: 23.1% vs. 18.3%), when applied at same interdental spaces (p < 0.001).",[],['cylindrical IDB (C-IDB'],['waist-shaped IDBs cleaned'],[],"[{'cui': 'C0205114', 'cui_str': 'Cylindrical'}]","[{'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}]",28.0,0.0264411,"The waist-shaped IDBs cleaned significantly better than their cylindrically-shaped counterparts (area cleaned: 23.1% vs. 18.3%), when applied at same interdental spaces (p < 0.001).","[{'ForeName': 'Pune N', 'Initials': 'PN', 'LastName': 'Paqué', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032, Zurich, Switzerland. punenina.paque@zzm.uzh.ch.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Attin', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032, Zurich, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ender', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032, Zurich, Switzerland.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Al-Majid', 'Affiliation': 'Dental department, King Faisal Hospital, Prince Muqrin St 1, 36361, Alhofuf, Saudi Arabia.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Wegehaupt', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032, Zurich, Switzerland.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Sener', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032, Zurich, Switzerland.'}, {'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Schmidlin', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032, Zurich, Switzerland.'}]",Scientific reports,['10.1038/s41598-020-64816-5']
628,32404919,Short rehabilitation training program may improve postural control in children with autism spectrum disorders: preliminary evidences.,"Autism Spectrum Disorders subjects (ASD) is characterized by postural control deficits. This study aimed to explore the effect of a short postural rehabilitation training program on postural capabilities in children with ASD. Two groups (G1 and G2) of twenty children with ASD of IQ-, sex- and age- matched (mean age 11.7 ± 2.4 years) were included in this study. Posture was recorded by using the Balance Quest from Framiral on unstable platform in three different viewing conditions. The rehabilitation program consisted in two distinct postural control training exercises. Postural recordings were performed twice at T1 and T2 for both groups of children. Between T1 and T2 a 6-minute postural training was performed by the G1 group only, while the G2 group had a 6-minute of rest. Children were allocated randomly to the G1 or G2 groups. At T1, postural instability was similar for both groups of ASD children (G1 and G2) desp+\ite viewing conditions. At T2, we observed an improvement of postural control related to a mixed effect of training rehabilitation but also of test-retest. Knowing the potential of new rehabilitation strategies, the impact of postural control deficit in ASD children needs to be reconsidered. Well design case-control studies are requested to ensure scientific validity of postural rehabilitation training program.",2020,"At T1, postural instability was similar for both groups of ASD children (G1 and G2) desp+\ite viewing conditions.","['children with ASD', 'Autism Spectrum Disorders subjects (ASD', 'children with autism spectrum disorders', 'twenty children with ASD of IQ-, sex- and age- matched (mean age 11.7\u2009±\u20092.4 years']","['short postural rehabilitation training program', 'Short rehabilitation training program', 'rehabilitation program consisted in two distinct postural control training exercises']","['postural capabilities', 'postural instability', 'postural control']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517535', 'cui_str': '11.7'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C1843921', 'cui_str': 'Postural instability'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}]",20.0,0.0112101,"At T1, postural instability was similar for both groups of ASD children (G1 and G2) desp+\ite viewing conditions.","[{'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Caldani', 'Affiliation': 'UMR 1141 NeuroDiderot Inserm, Paris University, Robert Debré Hospital, Paris, France. simona.caldani@gmail.com.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Atzori', 'Affiliation': 'Child and Adolescent Psychiatry Department, APHP, Robert Debré Hospital, Paris, France.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Peyre', 'Affiliation': 'UMR 1141 NeuroDiderot Inserm, Paris University, Robert Debré Hospital, Paris, France.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Delorme', 'Affiliation': 'Child and Adolescent Psychiatry Department, APHP, Robert Debré Hospital, Paris, France.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Bucci', 'Affiliation': 'UMR 1141 NeuroDiderot Inserm, Paris University, Robert Debré Hospital, Paris, France.'}]",Scientific reports,['10.1038/s41598-020-64922-4']
629,32404980,Proteomic profiles before and during weight loss: Results from randomized trial of dietary intervention.,"Inflammatory and cardiovascular biomarkers have been associated with obesity, but little is known about how they change upon dietary intervention and concomitant weight loss. Further, protein biomarkers might be useful for predicting weight loss in overweight and obese individuals. We performed secondary analyses in the Diet Intervention Examining The Factors Interacting with Treatment Success (DIETFITS) randomized intervention trial that included healthy 609 adults (18-50 years old) with BMI 28-40 kg/m 2 , to evaluate associations between circulating protein biomarkers and BMI at baseline, during a weight loss diet intervention, and to assess predictive potential of baseline blood proteins on weight loss. We analyzed 263 plasma proteins at baseline and 6 months into the intervention using the Olink Proteomics CVD II, CVD III and Inflammation arrays. BMI was assessed at baseline, after 3 and 6 months of dietary intervention. At baseline, 102 of the examined inflammatory and cardiovascular biomarkers were associated with BMI (>90% with successful replication in 1,584 overweight/obese individuals from a community-based cohort study) and 130 tracked with weight loss shedding light into the pathophysiology of obesity. However, out of 263 proteins analyzed at baseline, only fibroblast growth factor 21 (FGF-21) predicted weight loss, and none helped individualize dietary assignment.",2020,"However, out of 263 proteins analyzed at baseline, only fibroblast growth factor 21 (FGF-21) predicted weight loss, and none helped individualize dietary assignment.","['overweight and obese individuals', 'healthy 609 adults (18-50 years old) with BMI 28-40\u2009kg/m 2']",['dietary intervention'],"['fibroblast growth factor 21 (FGF-21) predicted weight loss', 'weight loss', 'BMI']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",1584.0,0.0195217,"However, out of 263 proteins analyzed at baseline, only fibroblast growth factor 21 (FGF-21) predicted weight loss, and none helped individualize dietary assignment.","[{'ForeName': 'Sylwia M', 'Initials': 'SM', 'LastName': 'Figarska', 'Affiliation': 'Department of Medicine, Division of Cardiovascular Medicine, Stanford University School of Medicine, Stanford, CA, 94305, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rigdon', 'Affiliation': 'Quantitative Sciences Unit, Stanford University School of Medicine, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ganna', 'Affiliation': 'Program in Medical and Population Genetics, Broad Institute of MIT and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Sölve', 'Initials': 'S', 'LastName': 'Elmståhl', 'Affiliation': 'Department of Clinical Sciences, Division of Geriatric Medicine, Lund University, Malmö University Hospital, Malmö, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Lind', 'Affiliation': 'Department of Medical Sciences, Cardiovascular Epidemiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Gardner', 'Affiliation': 'Stanford Diabetes Research Center, Stanford, CA, 94305, USA. cgardner@stanford.edu.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Ingelsson', 'Affiliation': 'Department of Medicine, Division of Cardiovascular Medicine, Stanford University School of Medicine, Stanford, CA, 94305, USA.'}]",Scientific reports,['10.1038/s41598-020-64636-7']
630,32405071,Continuing versus suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers: Impact on adverse outcomes in hospitalized patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).,"Background


Angiotensin-converting enzyme-2 (ACE2) may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB). Because renin-angiotensin system blockers increase levels of ACE2, a protein that facilitates coronavirus entry into cells, there is concern that these drugs could increase the risk of developing a severe and fatal form of COVID-19. The impact of discontinuing ACEI and ARBs in patients with COVID-19 remains uncertain. DESIGN BRACE CORONA is a pragmatic, multicenter, randomized, phase IV, clinical trial that aims to enroll around 500 participants at 32 sites in Brazil. Participants will be identified from an ongoing national registry of suspected and confirmed cases of COVID-19. Eligible patients using renin-angiotensin system blockers (ACEI/ARBs) with a confirmed diagnosis of COVID-19 will be randomized to a strategy of continued ACEI/ARB treatment versus temporary discontinuation for 30 days. The primary outcome is the median days alive and out of the hospital at 30 days. Secondary outcomes include progression of COVID-19 disease, all-cause mortality, death from vascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, troponin, B-type natriuretic peptide, N-terminal-pro hormone and D-dimer levels.
Summary


BRACE CORONA will evaluate whether the strategy of continued ACEI/ARB therapy compared with temporary discontinuation of these drugs impacts clinical outcomes among patients with COVID-19.",2020,"Secondary outcomes include progression of COVID-19 disease, all-cause mortality, death from vascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, troponin, B-type natriuretic peptide, N-terminal-pro hormone and D-dimer levels.
","['patients with COVID-19', 'hospitalized patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2', 'patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB', '500 participants at 32 sites in Brazil', 'patients with COVID-19 remains uncertain', 'Eligible patients using renin-angiotensin system blockers (ACEI/ARBs) with a confirmed diagnosis of COVID-19']","['suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers', '\n\n\nAngiotensin-converting enzyme-2 (ACE2']","['progression of COVID-19 disease, all-cause mortality, death from vascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, troponin, B-type natriuretic peptide, N-terminal-pro hormone and D-dimer levels', 'median days alive and out of the hospital at 30\xa0days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0038959', 'cui_str': 'Suspending Agents'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027059', 'cui_str': 'Myocarditis'}, {'cui': 'C0031046', 'cui_str': 'Pericarditis'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0020546', 'cui_str': 'Hypertensive crisis'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",500.0,0.154131,"Secondary outcomes include progression of COVID-19 disease, all-cause mortality, death from vascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, troponin, B-type natriuretic peptide, N-terminal-pro hormone and D-dimer levels.
","[{'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Ariane Vieira Scarlatelli', 'Initials': 'AVS', 'LastName': 'Macedo', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Pedro Gabriel Melo', 'Initials': 'PGM', 'LastName': 'de Barros E Silva', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Renata Junqueira', 'Initials': 'RJ', 'LastName': 'Moll-Bernardes', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Feldman', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': ""D'Andréa Saba Arruda"", 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Andrea Silvestre', 'Initials': 'AS', 'LastName': 'de Souza', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Denilson Campos', 'Initials': 'DC', 'LastName': 'de Albuquerque', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Mazza', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Mayara Fraga', 'Initials': 'MF', 'LastName': 'Santos', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Natalia Zerbinatti', 'Initials': 'NZ', 'LastName': 'Salvador', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Olga Ferreira', 'Initials': 'OF', 'LastName': 'de Souza', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}]",American heart journal,['10.1016/j.ahj.2020.05.002']
631,32406009,The effect of TJ-28 (Eppikajutsuto) on the prevention of hand-foot syndrome using Capecitabine for colorectal cancer: The Yokohama Clinical Oncology Group Study (YCOG1102).,"BACKGROUND


Eppikajututo (TJ-28, a Kampo medicine) is effective against rheumatoid arthritis and eczema. We conducted a randomized comparative trial to assess the efficacy of TJ-28 for preventing hand-foot syndrome (HFS) as a complication of adjuvant chemotherapy using capecitabine.
METHODS


The present study was a multi-institutional randomized-controlled trial (UMIN000005899). Colorectal cancer patients scheduled to receive capecitabine chemotherapy as adjuvant therapy were randomly assigned to receive TJ-28 (7500 mg/day) or oral pyridoxine (60 mg/day). Patients were monitored for the development of grade ≥ 2 HFS according to the National Cancer Institute Common Toxicity Criteria until chemotherapy completion.
RESULTS


Twenty-two patients were enrolled in this study. The relative dose intensity of capecitabine was 76.2% in the TJ-28 group and 68.2% in the pyridoxine group. Grade ≥ 2 HFS developed in 6 (50.0%) of 12 TJ-28 patients and in 4 (40.0%) of 10 pyridoxine patients. Chemotherapy treatment failure was observed in seven patients, mainly due to HFS, liver dysfunction, diarrhea, and neutropenia. Chemotherapy treatment failure due to HFS occurred in none of the TJ-28 group and 2 patients (20.0%) in the pyridoxine group (p = 0.114).
CONCLUSION


Capecitabine-associated HFS was not markedly prevented by TJ-28 compared with pyridoxine. However, TJ-28 might support the continuation of chemotherapy with capecitabine. Further studies are warranted to clarify the benefits of TJ-28.",2020,The relative dose intensity of capecitabine was 76.2% in the TJ-28 group and 68.2% in the pyridoxine group.,"['colorectal cancer', 'Colorectal cancer patients scheduled to receive', 'Twenty-two patients were enrolled in this study']","['TJ-28 (Eppikajutsuto', 'Capecitabine', 'oral pyridoxine', 'TJ-28', 'capecitabine chemotherapy', 'capecitabine', 'pyridoxine']","['Chemotherapy treatment failure due to HFS', 'HFS, liver dysfunction, diarrhea, and neutropenia', 'Chemotherapy treatment failure', 'Grade ≥', 'HFS']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4549708', 'cui_str': 'eppikajutsuto'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0034272', 'cui_str': 'pyridoxine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",22.0,0.103454,The relative dose intensity of capecitabine was 76.2% in the TJ-28 group and 68.2% in the pyridoxine group.,"[{'ForeName': 'Kazuteru', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Department of Gastroenterological Surgery, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Ishibe', 'Affiliation': 'Department of Gastroenterological Surgery, Yokohama City University, Yokohama, Japan. a.ishibe1225@gmail.com.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Watanabe', 'Affiliation': 'Department of Gastroenterological Center, Yokohama City University Medical center, Yokohama, Japan.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Ota', 'Affiliation': 'Department of Gastroenterological Surgery, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Shoichi', 'Initials': 'S', 'LastName': 'Fujii', 'Affiliation': 'Department of Surgery, Koga Hospital, Shizuoka, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Ichikawa', 'Affiliation': 'Department of Oncology, Yokohama City University , Yokohama, Japan.'}, {'ForeName': 'Mari S', 'Initials': 'MS', 'LastName': 'Oba', 'Affiliation': 'Department of Biostatics, Yokohama City University , Yokohama, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Endo', 'Affiliation': 'Department of Gastroenterological Surgery, Yokohama City University, Yokohama, Japan.'}]",Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology,['10.1007/s12664-020-01039-6']
632,32406100,Comparison Between Minimal Fluoroscopy and Conventional Approaches for Visually Guided Laser Balloon Pulmonary Vein Isolation Ablation.,"INTRODUCTION


Although balloon-based techniques such as the laser balloon (LB) ablation have simplified pulmonary vein isolation (PVI), procedural fluoroscopy usage remains higher in comparison to radiofrequency PVI approaches due to limited 3-dimensional mapping system integration.
METHODS


In this prospective study, 50 consecutive patients were randomly assigned in alternating fashion to a low fluoroscopy group (LFG, n=25) or conventional fluoroscopy group (CFG, n=25) and underwent de novo PVI procedures using visually guided LB technique.
RESULTS


There was no statistical difference in baseline characteristics or cross-overs between treatment groups. Acute PVI was accomplished in all patients. Mean follow up was 318 ± 69 days. Clinical recurrence of AF after PVI was similar between groups (CFG: 19% vs LFG: 15%; p=0.72). Total fluoroscopy time was significantly lower in the LFG than the CFG (1.7 ± 1.4 min vs. 16.9 ± 5.9 min; p < 0.001) despite similar total procedure duration (143 ± 22 min vs. 148 ± 22 min; p= 0.42) and mean LA dwell time (63 ± 15 min vs. 59 ± 10 min; p=0.28). Mean DAP was significantly lower in the LFG (181 ± 125 μGym2 vs. 1980 ± 750 μGym2; p < 0.001). Fluoroscopy usage after transseptal access was substantially lower in the LFG (0.63 ± 0.43 min vs. 11.70 ± 4.32 min; p < 0.001). Complications rates were similar between both groups (4% vs. 2%; p=0.57).
CONCLUSIONS


This study demonstrates that LB PVI can be safely achieved using a novel low fluoroscopy protocol while also substantially reducing fluoroscopy usage and radiation exposure in comparison to conventional approaches for LB ablation. This article is protected by copyright. All rights reserved.",2020,Clinical recurrence of AF after PVI was similar between groups (CFG: 19% vs LFG: 15%; p=0.72).,['50 consecutive patients'],"['Minimal Fluoroscopy and Conventional Approaches for Visually Guided Laser Balloon Pulmonary Vein Isolation Ablation', 'LB PVI', 'LFG', 'laser balloon (LB) ablation', 'low fluoroscopy group (LFG, n=25) or conventional fluoroscopy group (CFG, n=25) and underwent de novo PVI procedures using visually guided LB technique']","['Acute PVI', 'Mean DAP', 'Fluoroscopy usage after transseptal access', 'Clinical recurrence of AF after PVI', 'mean LA dwell time', 'Total fluoroscopy time', 'Complications rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0045587', 'cui_str': '2,6-diaminopurine'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0442381', 'cui_str': 'Transseptal nasal approach'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0429659', 'cui_str': 'Dwell time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",50.0,0.0493569,Clinical recurrence of AF after PVI was similar between groups (CFG: 19% vs LFG: 15%; p=0.72).,"[{'ForeName': 'Henry D', 'Initials': 'HD', 'LastName': 'Huang', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Rodriguez', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Serafini', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Macias', 'Affiliation': 'UCLA Cardiac Arrhythmia Center, Ronald Reagan UCLA Medical Center, Los Angeles, California.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Winterfield', 'Affiliation': 'Division of Cardiology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Parikshit S', 'Initials': 'PS', 'LastName': 'Sharma', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Larsen', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Kousik', 'Initials': 'K', 'LastName': 'Krishnan', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Trohman', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, Chicago, IL.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14546']
633,32406111,Three-year outcomes from the CRADLE study in de novo pediatric kidney transplant recipients receiving everolimus with reduced tacrolimus and early steroid withdrawal.,"CRADLE was a 36-month multicenter study in pediatric (≥1 to <18 years) kidney transplant recipients randomized at 4-6 weeks post-transplantation to receive everolimus+reduced-exposure tacrolimus (EVR+rTAC; N=52) with corticosteriod withdrawal at 6-month post-transplantation or continue mycophenolate mofetil+standard-exposure TAC (MMF+sTAC; N=54) with corticosteroids. The incidence of composite efficacy failure (biopsy-proven acute rejection [BPAR], graft loss, or death) at Month 36 was 9.8% versus 9.6% (difference: 0.2%; 80% confidence interval: -7.3 to 7.7) for EVR+rTAC and MMF+sTAC, respectively, which was driven by BPARs. Graft loss was low (2.1% vs 3.8%) with no deaths. Mean estimated glomerular filtration rate at Month 36 was comparable between groups (68.1 vs 67.3 mL/min/1.73 m 2  ). Mean changes (z-score) in height (0.72 vs 0.39; P=0.158) and weight (0.61 vs 0.82; P=0.453) from randomization to Month 36 were comparable, while growth in pre-pubertal patients on EVR+rTAC was better (P=0.050) versus MMF+sTAC. The overall incidence of adverse events (AEs) and serious AEs was comparable between groups. Rejection was the leading AE for study drug discontinuation in the EVR+rTAC group. In conclusion, though AE-related study drug discontinuation was higher, an EVR+rTAC regimen represents an alternative treatment option that enables withdrawal of steroids as well as reduction of CNIs for pediatric KTRs.",2020,"Mean changes (z-score) in height (0.72 vs 0.39; P=0.158) and weight (0.61 vs 0.82; P=0.453) from randomization to Month 36 were comparable, while growth in pre-pubertal patients on EVR+rTAC was better (P=0.050) versus MMF+sTAC.","['pediatric kidney transplant recipients receiving everolimus with reduced tacrolimus and early steroid withdrawal', 'pediatric (≥1 to <18 years) kidney transplant recipients randomized at']",['4-6 weeks post-transplantation to receive everolimus+reduced-exposure tacrolimus (EVR+rTAC; N=52) with corticosteriod withdrawal at 6-month post-transplantation or continue mycophenolate mofetil+standard-exposure TAC (MMF+sTAC; N=54) with corticosteroids'],"['incidence of composite efficacy failure (biopsy-proven acute rejection [BPAR], graft loss, or death', 'weight', 'Mean estimated glomerular filtration rate', 'overall incidence of adverse events (AEs) and serious AEs', 'Graft loss']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0550015,"Mean changes (z-score) in height (0.72 vs 0.39; P=0.158) and weight (0.61 vs 0.82; P=0.453) from randomization to Month 36 were comparable, while growth in pre-pubertal patients on EVR+rTAC was better (P=0.050) versus MMF+sTAC.","[{'ForeName': 'Burkhard', 'Initials': 'B', 'LastName': 'Tönshoff', 'Affiliation': ""Department of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg, Germany.""}, {'ForeName': 'Helio', 'Initials': 'H', 'LastName': 'Tedesco', 'Affiliation': 'Nephrology Division, Hospital do Rim, UNIFESP, São Paulo, Brazil.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ettenger', 'Affiliation': ""Division of Pediatric Nephrology, UCLA Mattel Children's Hospital, Los Angeles, CA, USA.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Christian', 'Affiliation': ""Department of Pediatric Nephrology, Nottingham Children's Hospital, Nottingham, UK.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bjerre', 'Affiliation': 'Division of Pediatric and Adolescent Medicine, Department of Pediatrics, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Dello Strologo', 'Affiliation': ""Nephrology Unit, Department of Pediatrics, Institute for Scientific Research, Bambino Gesù Children's Hospital, Rome, Italy.""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Marks', 'Affiliation': 'Department of Pediatric Nephrology, Great Ormond Street Hospital for Children, NHS Foundation Trust and University College London Great Ormond Street Institute of Child Health, NIHR Great Ormond Street Hospital Biomedical Research Centre, London, UK.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Pape', 'Affiliation': 'Department of Pediatric Nephrology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Udaykiran', 'Initials': 'U', 'LastName': 'Veldandi', 'Affiliation': 'Novartis Healthcare Pvt. Ltd, Hyderabad, India.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Lopez', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Cousin', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Priti', 'Initials': 'P', 'LastName': 'Pandey', 'Affiliation': 'Novartis Healthcare Pvt. Ltd, Hyderabad, India.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Meier', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16005']
634,32406112,Randomised clinical trial: linaclotide vs placebo-a study of bi-directional gut and brain axis.,"BACKGROUND


Linaclotide, a guanylate cyclase C agonist relieves irritable bowel syndrome with predominant constipation (IBS-C) symptoms, but how it improves pain in humans is unknown.
AIMS


To investigate the effects of linaclotide and placebo on the afferent and efferent gut-brain-gut signalling in IBS-C patients, in a randomised clinical trial.
METHODS


Patients with IBS-C (Rome III) and rectal hypersensitivity were randomised (2:1) to receive linaclotide (290 µg) or placebo for 10 weeks and undergo bi-directional gut and brain axis assessment using anorectal electrical stimulations and transcranial/transspinal-anorectal magnetic stimulations. Rectal sensations were examined by balloon distention. Assessments included abdominal pain, bowel symptoms and quality of life (QOL) scores. Primary outcomes were latencies of recto-cortical and cortico-rectal evoked potentials.
RESULTS


Thirty-nine patients participated; 26 received linaclotide and 13 received placebo. Rectal cortical evoked potentials latencies (milliseconds) were significantly prolonged with linaclotide compared to baseline (P1:Δ 19 ± 6, P < 0.005; N1:Δ 20 ± 7, P < 0.02) but not with placebo (P1:Δ 3 ± 5; N1:Δ 4.7 ± 5,P = 0.3) or between groups. The efferent cortico-anorectal and spino-anorectal latencies were unchanged. The maximum tolerable rectal volume (cc) increased significantly with linaclotide compared to baseline (P < 0.001) and placebo (Δ 29 ± 10 vs 4 ± 20, (P < 0.03). Abdominal pain decreased (P < 0.001) with linaclotide but not between groups. Complete spontaneous bowel movement frequency increased (P < 0.001), and IBS-QOL scores improved (P = 0.01) with linaclotide compared to baseline and placebo. There was no difference in overall responders between linaclotide and placebo (54% vs 23%, P = 0.13).
CONCLUSIONS


Linaclotide prolongs afferent gut-brain signalling from baseline but both afferent and efferent signalling were unaffected compared to placebo. Linaclotide significantly improves rectal hypersensitivity, IBS-C symptoms and QOL compared to placebo. These mechanisms may explain the effects of linaclotide on pain relief in IBS-C patients. ClinicalTrials.Gov: Registered at Clinical trials.gov no NCT02078323.",2020,"Complete spontaneous bowel movement frequency increased (P < 0.001), and IBS-QOL scores improved (P = 0.01) with linaclotide compared to baseline and placebo.","['Thirty-nine patients participated; 26 received', 'IBS-C patients', 'Patients with IBS-C (Rome III) and rectal hypersensitivity']","['linaclotide', 'linaclotide (290\xa0µg) or placebo for 10\xa0weeks and undergo bi-directional gut and brain axis assessment using anorectal electrical stimulations and transcranial/transspinal-anorectal magnetic stimulations', 'Linaclotide', 'linaclotide vs placebo', 'linaclotide and placebo', 'placebo']","['abdominal pain, bowel symptoms and quality of life (QOL) scores', 'pain relief', 'overall responders', 'rectal hypersensitivity, IBS-C symptoms and QOL', 'Rectal sensations', 'latencies of recto-cortical and cortico-rectal evoked potentials', 'IBS-QOL scores', 'efferent cortico-anorectal and spino-anorectal latencies', 'Abdominal pain', 'Rectal cortical evoked potentials latencies (milliseconds', 'Complete spontaneous bowel movement frequency', 'maximum tolerable rectal volume (cc']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C2000261', 'cui_str': 'linaclotide'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0232717', 'cui_str': 'Rectal sensation'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0205116', 'cui_str': 'Efferent'}, {'cui': 'C0439223', 'cui_str': 'ms'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0426642', 'cui_str': 'Frequency of bowel action'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",39.0,0.636366,"Complete spontaneous bowel movement frequency increased (P < 0.001), and IBS-QOL scores improved (P = 0.01) with linaclotide compared to baseline and placebo.","[{'ForeName': 'Satish S C', 'Initials': 'SSC', 'LastName': 'Rao', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Xuelian', 'Initials': 'X', 'LastName': 'Xiang', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Kulthep', 'Initials': 'K', 'LastName': 'Rattanakovit', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Tanisa', 'Initials': 'T', 'LastName': 'Patcharatrakul', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Parr', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Ayyala', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Amol', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15772']
635,32406919,"Changes in Dietary Inflammatory Potential Predict Changes in Sleep Quality Metrics, but Not Sleep Duration.","STUDY OBJECTIVES


Non-pharmacological sleep interventions may improve sleep profiles without the side-effects observed with many pharmacological sleep aids. The objective of this research was to examine the association between sleep and inflammation and to examine how changes in dietary inflammatory potential influence changes in sleep.
METHODS


The Inflammation Management Intervention Study (IMAGINE), which was a dietary intervention designed to lower inflammation, provided access to 24-hour dietary recalls (24HR), objectively measured sleep using Sensewear™ armbands, and a range of self-reported demographics, health histories, lifestyle behaviors, psychosocial metrics, anthropometric measurements, and inflammatory biomarkers. Dietary Inflammatory Index (DII®) scores were calculated from three unannounced 24HR-derived estimated intakes of whole foods and micro and macronutrients over a 2-week period at baseline and post-intervention (i.e., month 3). Statistical analyses primarily utilized linear regression.
RESULTS


At baseline, for every one-minute increase in sleep onset latency (SOL), tumor necrosis factor-α (TNF-α) increased by 0.015 pg/ml (± 0.008, P=0.05). Every one-percentage increase in sleep efficiency was associated with decreased C-reactive protein (CRP) of -0.088 mg/L (± 0.032, P=0.01). Every one-minute increase in wake-after-sleep-onset (WASO) increased both CRP and interleukin-6. Compared to participants with pro-inflammatory DII changes over 3 months, those with anti-inflammatory changes decreased WASO (0 vs. -25 minutes, respectively, P<0.01) and improved sleep efficiency (-2.1% vs. +2.6%, respectively, P=0.04).
CONCLUSION


Non-pharmacological treatments, such as anti-inflammatory diets, may improve sleep in some adults. Future research involving dietary treatments to improve sleep should not only focus on the general population, but in those commonly experiencing co-morbid sleep complaints.",2020,"Every one-percentage increase in sleep efficiency was associated with decreased C-reactive protein (CRP) of -0.088 mg/L (± 0.032, P=0.01).",[],[],"['C-reactive protein (CRP', 'Sleep Quality Metrics', 'Dietary Inflammatory Index (DII®) scores', '24-hour dietary recalls (24HR), objectively measured sleep using Sensewear™ armbands, and a range of self-reported demographics, health histories, lifestyle behaviors, psychosocial metrics, anthropometric measurements, and inflammatory biomarkers', 'WASO', 'sleep onset latency (SOL), tumor necrosis factor-α (TNF-α', 'sleep efficiency']",[],[],"[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0385506', 'cui_str': 'didodecylindocarbocyanine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1301852', 'cui_str': 'Armband'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0455458', 'cui_str': 'PMH - past medical history'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",,0.0144196,"Every one-percentage increase in sleep efficiency was associated with decreased C-reactive protein (CRP) of -0.088 mg/L (± 0.032, P=0.01).","[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Wirth', 'Affiliation': 'College of Nursing, University of South Carolina, Columbia, SC.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Jessup', 'Affiliation': 'Department of Epidemiology and Biostatistics Columbia, SC.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Turner-McGrievy', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, Arnold School of Public Health, Columbia, SC.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Shivappa', 'Affiliation': 'Department of Epidemiology and Biostatistics Columbia, SC.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Hurley', 'Affiliation': 'Cancer Prevention and Control Program, Arnold School of Public Health, University of South Carolina, Columbia, SC.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Hébert', 'Affiliation': 'Department of Epidemiology and Biostatistics Columbia, SC.'}]",Sleep,['10.1093/sleep/zsaa093']
636,32406964,"Prospective Cohort Study of Child Mouthing of Feces and Fomites in Urban Dhaka, Bangladesh (CHoBI7 Program).","OBJECTIVE


To characterize childhood mouthing and handling behaviors and to assess the association between hand-to-object and object-to-mouth contacts and diarrhea prevalence in young children in urban Dhaka, Bangladesh.
METHODS


A prospective cohort study was conducted among 494 children under 5 years of age in Dhaka, Bangladesh. This study was nested within the randomized controlled trial of the Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) mobile health (mHealth) program. The CHoBI7 mobile health program focuses on promoting handwashing with soap and water treatment to diarrhea patients and their household members through mobile messages and face-to-face visits. Mouthing and handling of feces and fomites among young children was measured by five-hour structured observation and caregiver reports. Diarrhea surveillance data was collected monthly for 12 months.
RESULTS


55% of caregivers reported that their child put a visibly dirty fomite (object or soil) in their mouth in the past week. Caregivers reported that 50% of children had mouthed visibly dirty objects, 26% had mouthed dirt, and 2% had mouthed feces. 45% of children were observed mouthing a visibly dirty fomite during structured observation. 40% of children were observed mouthing an object, 10% were observed mouthing soil, and one child (0.2%) was observed mouthing feces. Mouthing of visibly dirty fomites was most frequent among children 12-18 months of age; 69% of these children were reported to do so by caregivers, and 54% were observed doing so. Children with caregiver reports of mouthing feces had significantly higher odds of diarrhea over the subsequent month (Odds Ratio: 4.54; 95% Confidence Interval: 1.06, 19.48).
CONCLUSION


These findings demonstrate that mouthing of contaminated fomites among young children is frequent in urban environments in Bangladesh, and that mouthing feces is associated with significantly higher odds of diarrhea. Interventions are urgently needed to protect young children from fecal pathogens in their play spaces.",2020,"Children with caregiver reports of mouthing feces had significantly higher odds of diarrhea over the subsequent month (Odds Ratio: 4.54; 95% Confidence Interval: 1.06, 19.48).
","['young children in urban Dhaka', 'young children', 'Child Mouthing of Feces and Fomites in Urban Dhaka, Bangladesh (CHoBI7 Program', '494 children under 5 years of age in Dhaka, Bangladesh']",['Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) mobile health (mHealth) program'],"['diarrhea', 'visibly dirty objects', 'diarrhea prevalence', 'visibly dirty fomite (object or soil', 'Diarrhea surveillance data', 'visibly dirty fomite']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1008855', 'cui_str': 'Fomites'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0008354', 'cui_str': 'Cholera'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0008354', 'cui_str': 'Cholera'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C1008855', 'cui_str': 'Fomites'}, {'cui': 'C0037592', 'cui_str': 'Soil'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}]",494.0,0.0478912,"Children with caregiver reports of mouthing feces had significantly higher odds of diarrhea over the subsequent month (Odds Ratio: 4.54; 95% Confidence Interval: 1.06, 19.48).
","[{'ForeName': 'Tahmina', 'Initials': 'T', 'LastName': 'Parvin', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Ismat Minhaj', 'Initials': 'IM', 'LastName': 'Uddin', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Sazzadul Islam', 'Initials': 'SI', 'LastName': 'Bhuyian', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Saxton', 'Affiliation': 'Department of International Health, Johns Hopkins School of Public Health, Baltimore, United States.'}, {'ForeName': 'Fatema', 'Initials': 'F', 'LastName': 'Zohura', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Marzia', 'Initials': 'M', 'LastName': 'Sultana', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Fatema-Tuz', 'Initials': 'FT', 'LastName': 'Johura', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Shirajum', 'Initials': 'S', 'LastName': 'Monira', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Tasdik', 'Initials': 'T', 'LastName': 'Hasan', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Nowshin', 'Initials': 'N', 'LastName': 'Papri', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Ahshanul', 'Initials': 'A', 'LastName': 'Haque', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Shwapon K', 'Initials': 'SK', 'LastName': 'Biswas', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Sack', 'Affiliation': 'Department of International Health, Johns Hopkins School of Public Health, Baltimore, United States.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Perin', 'Affiliation': 'Department of International Health, Johns Hopkins School of Public Health, Baltimore, United States.'}, {'ForeName': 'Munirul', 'Initials': 'M', 'LastName': 'Alam', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Marie George', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13413']
637,32406965,"Process Evaluation for the Delivery of a Water, Sanitation, and Hygiene Mobile Health Program: Findings from the Randomized Controlled Trial of the CHoBI7 Mobile Health Program.","OBJECTIVE


The Cholera-Hospital-Based-Intervention-for-7-days (CHoBI7) mobile health (mHealth) program delivers mobile messages to diarrhea patient households promoting water treatment and handwashing with soap. The randomized controlled trial (RCT) of the CHoBI7 mHealth program demonstrated this intervention was effective in significantly reducing diarrhea and stunting in young children. The objective of this study was to assess the implementation of the CHoBI7 mHealth program in delivering mHealth messages during this RCT.
METHODS


517 diarrhea patient households received weekly text, voice, and interactive voice response (IVR) messages from the CHoBI7 mHealth program over the 12-month program period. The program process evaluation indicators were the following: the percentage of CHoBI7 mHealth messages received (program fidelity and dose) and fully listened to by program households (program fidelity and dose), and beneficiaries reporting receiving and sharing a mHealth message from the program (program reach) in the past two weeks.
RESULTS


92% of text messages were received by program households. 83% of voice and 86% of IVR messages sent were fully listened to by at least one household member. 81% of IVR quiz responses from households were answered correctly. Program households reported receiving a CHoBI7 mHealth message in the past two weeks at 79% of monthly household visits during the 12-month program. 77% of participants reported sharing a program message with a spouse, 55% with a neighbor, and 49% with a child during the program period.
CONCLUSION


There was high fidelity, dose, and reach of messages delivered for the CHoBI7 mHealth program. This study presents an approach for process evaluation that can be implemented to evaluate future mHealth programs.",2020,83% of voice and 86% of IVR messages sent were fully listened to by at least one household member.,"['young children', 'diarrhea patient households promoting water treatment and handwashing with soap', '517 diarrhea patient households received']","['CHoBI7 mHealth program', 'fully listened to by program households (program fidelity and dose), and beneficiaries reporting receiving and sharing a mHealth message from the program (program reach', 'Cholera-Hospital-Based-Intervention-for-7-days (CHoBI7) mobile health (mHealth) program', 'weekly text, voice, and interactive voice response (IVR) messages from the CHoBI7 mHealth program']",['diarrhea and stunting'],"[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0597684', 'cui_str': 'Water Treatment'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0037392', 'cui_str': 'Soap'}]","[{'cui': 'C0008354', 'cui_str': 'Cholera'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0042939', 'cui_str': 'Voice'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}]",,0.0465095,83% of voice and 86% of IVR messages sent were fully listened to by at least one household member.,"[{'ForeName': 'Md Sazzadul Islam', 'Initials': 'MSI', 'LastName': 'Bhuyian', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Saxton', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Hasan', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Jahed', 'Initials': 'J', 'LastName': 'Masud', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Fatema', 'Initials': 'F', 'LastName': 'Zohura', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Shirajum', 'Initials': 'S', 'LastName': 'Monira', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Shwapon Kumar', 'Initials': 'SK', 'LastName': 'Biswas', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'M Tasdik', 'Initials': 'MT', 'LastName': 'Hasan', 'Affiliation': ''}, {'ForeName': 'Tahmina', 'Initials': 'T', 'LastName': 'Parvin', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Ismat', 'Initials': 'I', 'LastName': 'Minhaj', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Kazi Md', 'Initials': 'KM', 'LastName': 'Zillur Rahman', 'Affiliation': 'University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Nowshin', 'Initials': 'N', 'LastName': 'Papri', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Mahamud-Ur', 'Initials': 'MU', 'LastName': 'Rashid', 'Affiliation': 'University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Lubaba', 'Initials': 'L', 'LastName': 'Sharin', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Teman', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Thomas', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Alland', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Labrique', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Sack', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Perin', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Munirul', 'Initials': 'M', 'LastName': 'Alam', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Christine Marie', 'Initials': 'CM', 'LastName': 'George', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13414']
638,32406989,Diarrheal Disease Knowledge among Household Members of Diarrhea Patients: Findings from the Randomized Controlled Trial of the Cholera-Hospital-Based-Intervention-for-7 Days (CHoBI7) Mobile Health Program.,"OBJECTIVE


The objective of this study was to evaluate the impact of the Cholera-Hospital-Based-Intervention-for-7-days (CHoBI7) handwashing with soap and water treatment mobile health (mHealth) program on diarrheal disease knowledge among diarrhea patients and their household members in urban Dhaka, Bangladesh.
METHODS


A cluster-randomized controlled trial of the CHoBI7 mHealth program was conducted among diarrhea patient households in Dhaka, Bangladesh. Patients were randomized to three arms: standard recommendation on oral rehydration solution use; health facility delivery of CHoBI7 plus mHealth (no home visits); and health facility delivery of CHoBI7 plus two home visits and mHealth. An open ended questionnaire was administered to 1468 participants 12 years of age or older on diarrheal disease transmission and prevention. These items were combined to form a diarrheal disease knowledge score measured at baseline and 1 week, 6 months, and 12 months.
RESULTS


At baseline, when participants were asked to report three ways diarrheal diseases were spread 37% (546/1468) of participants reported by water, 13% (187/1468) reported by lack of handwashing, and 4% (53/1468) by food not being covered properly. At baseline when asked to name three ways diarrheal diseases could be prevented, 35% (515/1468) of participants reported safe water, and 16% (228/1468) reported handwashing with soap. At the 12 month follow-up, the overall diarrhea knowledge score was significantly higher in mHealth with no home visits arm (score coefficient: 0.69, 95% Confidence Interval: 0.36, 1.01, p<0.0001) and the mHealth with two home visits arm (score coefficient: 1.18, 95% CI: 0.87, 1.50, p<0.0001) compared to the standard recommendation arm.
CONCLUSION


These findings suggest the CHoBI7 mHealth program presents a promising approach to increase diarrheal disease knowledge among diarrhea patient households.",2020,"At the 12 month follow-up, the overall diarrhea knowledge score was significantly higher in mHealth with no home visits arm (score coefficient: 0.69, 95% Confidence Interval: 0.36, 1.01, p<0.0001) and the mHealth with two home visits arm (score coefficient:","['diarrhea patients and their household members in urban Dhaka', 'diarrhea patient households in Dhaka, Bangladesh', 'diarrhea patient households', 'Household Members of Diarrhea Patients', '1468 participants 12 years of age or older on diarrheal disease transmission and prevention']","['CHoBI7 mHealth program', 'Cholera-Hospital-Based-Intervention-for-7 Days (CHoBI7) Mobile Health Program', 'Cholera-Hospital-Based-Intervention-for-7-days (CHoBI7) handwashing with soap and water treatment mobile health (mHealth) program', 'standard recommendation on oral rehydration solution use; health facility delivery of CHoBI7 plus mHealth (no home visits); and health facility delivery of CHoBI7 plus two home visits and mHealth']","['diarrheal disease knowledge', 'overall diarrhea knowledge score', 'diarrheal disease knowledge score']","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1290807', 'cui_str': 'Diarrheal disorder'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0008354', 'cui_str': 'Cholera'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0597684', 'cui_str': 'Water Treatment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0078516', 'cui_str': 'World Health Organization oral rehydration solution'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}]","[{'cui': 'C1290807', 'cui_str': 'Diarrheal disorder'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.131471,"At the 12 month follow-up, the overall diarrhea knowledge score was significantly higher in mHealth with no home visits arm (score coefficient: 0.69, 95% Confidence Interval: 0.36, 1.01, p<0.0001) and the mHealth with two home visits arm (score coefficient:","[{'ForeName': 'Jahed', 'Initials': 'J', 'LastName': 'Masud', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Md Sazzadul', 'Initials': 'MS', 'LastName': 'Islam Bhuyian', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Shwapon Kumar', 'Initials': 'SK', 'LastName': 'Biswas', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Fatema', 'Initials': 'F', 'LastName': 'Zohura', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Perin', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Nowshin', 'Initials': 'N', 'LastName': 'Papri', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Fahmida', 'Initials': 'F', 'LastName': 'Dil Farzana', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Tahmina', 'Initials': 'T', 'LastName': 'Parvin', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Shirajum', 'Initials': 'S', 'LastName': 'Monira', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Munirul', 'Initials': 'M', 'LastName': 'Alam', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Christine Marie', 'Initials': 'CM', 'LastName': 'George', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13415']
639,32406998,Safety and efficacy of the bioabsorbable polymer everolimus-eluting stent versus durable polymer drug-eluting stents in high-risk patients undergoing PCI: TWILIGHT-SYNERGY.,"BACKGROUND


Data examining the safety and efficacy of the bioabsorbable polymer (BP) drug-eluting stent (DES) as compared with durable polymer (DP) DES in high-risk patients undergoing percutaneous coronary intervention (PCI) remain limited.
METHODS


We conducted a pre-specified analysis among patients enrolled in the TWILIGHT trial treated with the SYNERGY BP-DES or a DP-DES. Following successful PCI and 3 months of ticagrelor plus aspirin, patients were randomized to aspirin or placebo for 1 year; DES choice was at physician discretion. The primary endpoint was target lesion failure (TLF) [composite of cardiac death, target vessel myocardial infarction (MI), clinically driven target lesion revascularization (TLR) or definite/probable stent thrombosis (ST)].
RESULTS


Among enrolled participants (N = 9006), 653 were treated exclusively with the SYNERGY BP-DES and 6404 with a comparator DP-DES. Over 15 months, TLF rates were 6.4% and 6.1% among those receiving a SYNERGY BP-DES and a DP-DES, respectively (adjusted HR 0.93; 95% CI 0.64 - 1.35; p = 0.72). The effect of ticagrelor monotherapy on Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding and the composite of all-cause death, MI or stroke was uniform across DES groups (both p int  >0.10).
CONCLUSIONS


The safety and efficacy profile of the SYNERGY BP-DES is comparable to that of contemporary DP-DES in high-risk patients undergoing PCI. Compared to ticagrelor plus aspirin, the effect of ticagrelor monotherapy is consistent among patients receiving SYNERGY BP-DES or DP-DES. This article is protected by copyright. All rights reserved.",2020,"The effect of ticagrelor monotherapy on Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding and the composite of all-cause death, MI or stroke was uniform across DES groups (both p int  >0.10).
","['high-risk patients undergoing percutaneous coronary intervention (PCI) remain limited', 'high-risk patients undergoing PCI', 'patients enrolled in the TWILIGHT trial treated with the SYNERGY BP-DES or a DP-DES', 'enrolled participants (N\xa0=\xa09006), 653 were treated exclusively with the SYNERGY BP-DES and 6404 with a comparator DP-DES']","['ticagrelor plus aspirin', 'bioabsorbable polymer everolimus-eluting stent versus durable polymer drug-eluting stents', 'bioabsorbable polymer (BP) drug-eluting stent (DES', 'durable polymer (DP) DES', 'ticagrelor monotherapy', 'aspirin or placebo']","['target lesion failure (TLF', 'Safety and efficacy', 'TLF rates', 'cardiac death, target vessel myocardial infarction (MI), clinically driven target lesion revascularization (TLR) or definite/probable stent thrombosis (ST']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",,0.196087,"The effect of ticagrelor monotherapy on Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding and the composite of all-cause death, MI or stroke was uniform across DES groups (both p int  >0.10).
","[{'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Baber', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, United States.'}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Chandiramani', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, United States.'}, {'ForeName': 'Shamir R', 'Initials': 'SR', 'LastName': 'Mehta', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Sartori', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, United States.'}, {'ForeName': 'Zhongjie', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, United States.'}, {'ForeName': 'Bimmer E', 'Initials': 'BE', 'LastName': 'Claessen', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, United States.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Briguori', 'Affiliation': 'Mediterranea Cardiocentro, Naples, Italy.'}, {'ForeName': 'Samin', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, United States.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dangas', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, United States.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, United States.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28995']
640,32401557,Parent-Child Agreement on Family Accommodation Differentially Predicts Outcomes of Child-Based and Parent-Based Child Anxiety Treatment.,"Objectives : Family accommodation is linked to poor treatment outcomes for childhood anxiety. Progress in research on the role of accommodation in treatment has been hindered by the relatively weak association between child and parent reports on accommodation. In this study, we suggest that parent-child agreement on family accommodation may provide a dependable estimation of this construct, and investigated whether the level of parent-child agreement on family accommodation predicts subsequent treatment outcome. We further examined whether the effect was greater in Supportive Parenting for Anxious Childhood Emotions (SPACE), which directly targets family accommodation, than in individual child-focused cognitive behavioral therapy (CBT). Methods : Participants were 104 children (aged 6-15) with anxiety disorders, and their mothers, randomized to SPACE or CBT. Accommodation was rated by mothers and children before treatment, halfway through treatment, and at treatment end, using respective versions of Family Accommodation Scale-Anxiety. To accurately estimate agreement, we conducted multilevel response surface analysis by polynomial regression, with agreement on accommodation at each time point predicting subsequent child anxiety severity, over the course of treatment. Results : Parent-child agreement and disagreement on accommodation were significant predictors of subsequent anxiety symptom severity. Different results were obtained for SPACE and CBT, suggesting potentially distinct underlying mechanisms. Conclusions : The findings suggest treatment-specific roles of accommodation in SPACE vs. CBT. Multiple-informant assessment of accommodation provides important information, which may have important implications for optimal treatment personalization.",2020,Parent-child agreement and disagreement on accommodation were significant predictors of subsequent anxiety symptom severity.,"['Participants were 104 children (aged 6-15) with anxiety disorders, and their mothers']",['SPACE or CBT'],['Family Accommodation'],"[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]",104.0,0.0155443,Parent-child agreement and disagreement on accommodation were significant predictors of subsequent anxiety symptom severity.,"[{'ForeName': 'Sigal', 'Initials': 'S', 'LastName': 'Zilcha-Mano', 'Affiliation': 'Department of Psychology, University of Haifa.'}, {'ForeName': 'Yaara', 'Initials': 'Y', 'LastName': 'Shimshoni', 'Affiliation': 'Child Study Center, School of Medicine, Yale University, Child Study Center, School of Medicine.'}, {'ForeName': 'Wendy K', 'Initials': 'WK', 'LastName': 'Silverman', 'Affiliation': 'Child Study Center, School of Medicine, Yale University, Child Study Center, School of Medicine.'}, {'ForeName': 'Eli R', 'Initials': 'ER', 'LastName': 'Lebowitz', 'Affiliation': 'Child Study Center, School of Medicine, Yale University, Child Study Center, School of Medicine.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2020.1756300']
641,32401589,Re: Randomised Clinical Trial of Prostate Artery Embolisation versus a Sham Procedure for Benign Prostatic Hyperplasia.,,2020,,['Benign Prostatic Hyperplasia'],['Prostate Artery Embolisation'],[],"[{'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}]","[{'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}]",[],,0.264533,,"[{'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Kaplan', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001100']
642,32401590,Re: Symptom Relief and Anejaculation after Aquablation or Transurethral Resection of the Prostate: Subgroup Analysis from a Blinded Randomized Trial.,,2020,,[],['Re: Symptom Relief and Anejaculation after Aquablation or Transurethral Resection of the Prostate'],[],[],"[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0278106', 'cui_str': 'Anejaculation'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}]",[],,0.247962,,"[{'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Kaplan', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001100.01']
643,32401600,"Efficacy and safety of a booster dose of the meningococcal A, C, W, Y-tetanus toxoid conjugate vaccine administered 10 years after primary vaccination and long-term persistence of tetanus toxoid conjugate or polysaccharide vaccine.","A previous phase 3, randomized, multicenter study showed the immunogenicity of a primary vaccination of subjects aged 11 to 17 years with the quadrivalent meningococcal vaccine conjugated to tetanus toxoid (MenACWY-TT) or the quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS). This extension study evaluated the safety and immunogenicity of a MenACWY-TT booster 10 years after receiving a primary dose of either MenACWY-TT or MenACWY-PS. The primary immunogenicity endpoint was booster response, evaluated using serum bactericidal antibody assays with rabbit complement (rSBA), 1 month postbooster. Safety endpoints included the percentage of subjects experiencing local and general adverse events (AEs) ≤4 days after MenACWY-TT booster. Of 229 subjects enrolled, 169 and 58 in the MenACWY-TT and MenACWY-PS groups, respectively, completed the booster phase. The 1 month postbooster response for each serogroup ranged from 81.5% to 95.7% for MenACWY-TT and 66.7% to 94.1% for MenACWY-PS. Similar percentages of MenACWY-TT and MenACWY-PS recipients had a booster response to serogroups A, W, and Y, whereas more MenACWY-TT recipients than MenACWY-PS recipients had a booster response to serogroup C. For the MenACWY-TT and MenACWY-PS groups, respectively, the MenACWY-TT booster elicited rSBA titers ≥1:8 in 100% and ≥98.0% of subjects across all serogroups; 100% and ≥96.1% of all subjects had titers ≥1:128. No new safety signals were observed during the booster phase. In conclusion, a MenACWY-TT booster dose after receiving either a primary dose of MenACWY-TT or MenACWY-PS elicited robust immune responses and was well tolerated. Functional antibody responses last up to 10 years after primary MenACWY-TT vaccination.",2020,"Similar percentages of MenACWY-TT and MenACWY-PS recipients had a booster response to serogroups A, W, and Y, whereas more MenACWY-TT recipients than MenACWY-PS recipients had a booster response to serogroup C. For the MenACWY-TT and MenACWY-PS groups, respectively, the MenACWY-TT booster elicited rSBA titers ≥1:8 in 100% and ≥98.0% of subjects across all serogroups; 100% and ≥96.1% of all subjects had titers ≥1:128.","['229 subjects enrolled, 169 and 58 in the MenACWY-TT and MenACWY-PS groups, respectively, completed the booster phase', 'subjects aged 11 to 17\xa0years with the']","['quadrivalent meningococcal vaccine conjugated to tetanus toxoid (MenACWY-TT) or the quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS', 'tetanus toxoid conjugate or polysaccharide vaccine', 'MenACWY-TT or MenACWY-PS']","['new safety signals', 'booster response, evaluated using serum bactericidal antibody assays with rabbit complement (rSBA), 1\xa0month postbooster', 'tolerated', 'Efficacy and safety', 'safety and immunogenicity', 'Functional antibody responses', 'percentage of subjects experiencing local and general adverse events (AEs']","[{'cui': 'C3529849', 'cui_str': 'tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine'}, {'cui': 'C2003457', 'cui_str': 'MenACWY'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0700144', 'cui_str': 'Meningococcus vaccine'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C3529849', 'cui_str': 'tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C2003457', 'cui_str': 'MenACWY'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C2936353', 'cui_str': 'Serum Bactericidal Antibody Assays'}, {'cui': 'C0324889', 'cui_str': 'Oryctolagus cuniculus'}, {'cui': 'C0009498', 'cui_str': 'Complement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",229.0,0.0353615,"Similar percentages of MenACWY-TT and MenACWY-PS recipients had a booster response to serogroups A, W, and Y, whereas more MenACWY-TT recipients than MenACWY-PS recipients had a booster response to serogroup C. For the MenACWY-TT and MenACWY-PS groups, respectively, the MenACWY-TT booster elicited rSBA titers ≥1:8 in 100% and ≥98.0% of subjects across all serogroups; 100% and ≥96.1% of all subjects had titers ≥1:128.","[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Quiambao', 'Affiliation': 'Clinical Research Division, Research Institute for Tropical Medicine, Alabang, Muntinlupa City, Philippines.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Peyrani', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Cutler', 'Affiliation': 'Pfizer Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Van Der Wielen', 'Affiliation': 'Vaccines R & D, GlaxoSmithKline, Wavre, Belgium.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Perez', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Webber', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Pfizer Inc, Hurley, UK.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1744363']
644,32401625,The Effect of Home Base Physical Activity Program based on the BASNEF Model on Motor Recovery in Patients with Stroke.,"The present study aimed to determine the effect of education based on the BASNEF model on the physical activity and improvement of motor activity in patients with stroke. This randomized control trial study was conducted on 40 patients with acute ischemic stroke admitted to a teaching hospital in Isfahan, Iran from August 2017 to September 2018. The patients were randomly divided into intervention and control groups. The intervention included personal education and a manual CD of physical activity for the intervention group. After education, the mean scores of the BASNEF model's constructs in the intervention group were significantly higher than those of the control group ( P  < .001). Furthermore, the motor ability of the intervention group in upper and lower extremities was significantly higher than that of the control group ( p  < .001). Interventions based on educational models can increase the motivation of patients with stroke in performing recommended physical activity.",2020,"Furthermore, the motor ability of the intervention group in upper and lower extremities was significantly higher than that of the control group ( p  < .001).","['Patients with Stroke', '40 patients with acute ischemic stroke admitted to a teaching hospital in Isfahan, Iran from August 2017 to September 2018', 'patients with stroke']",['Home Base Physical Activity Program'],"['motor ability', ""mean scores of the BASNEF model's constructs"", 'upper and lower extremities', 'motor activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",40.0,0.0142828,"Furthermore, the motor ability of the intervention group in upper and lower extremities was significantly higher than that of the control group ( p  < .001).","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Esteki-Ghashghaei', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Saadatnia', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Khorvash', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Shahnazi', 'Affiliation': 'Department of Health Education and Promotion, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Home health care services quarterly,['10.1080/01621424.2020.1765938']
645,32401715,"Triple combination of interferon beta-1b, lopinavir-ritonavir, and ribavirin in the treatment of patients admitted to hospital with COVID-19: an open-label, randomised, phase 2 trial.","BACKGROUND


Effective antiviral therapy is important for tackling the coronavirus disease 2019 (COVID-19) pandemic. We assessed the efficacy and safety of combined interferon beta-1b, lopinavir-ritonavir, and ribavirin for treating patients with COVID-19.
METHODS


This was a multicentre, prospective, open-label, randomised, phase 2 trial in adults with COVID-19 who were admitted to six hospitals in Hong Kong. Patients were randomly assigned (2:1) to a 14-day combination of lopinavir 400 mg and ritonavir 100 mg every 12 h, ribavirin 400 mg every 12 h, and three doses of 8 million international units of interferon beta-1b on alternate days (combination group) or to 14 days of lopinavir 400 mg and ritonavir 100 mg every 12 h (control group). The primary endpoint was the time to providing a nasopharyngeal swab negative for severe acute respiratory syndrome coronavirus 2 RT-PCR, and was done in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT04276688.
FINDINGS


Between Feb 10 and March 20, 2020, 127 patients were recruited; 86 were randomly assigned to the combination group and 41 were assigned to the control group. The median number of days from symptom onset to start of study treatment was 5 days (IQR 3-7). The combination group had a significantly shorter median time from start of study treatment to negative nasopharyngeal swab (7 days [IQR 5-11]) than the control group (12 days [8-15]; hazard ratio 4·37 [95% CI 1·86-10·24], p=0·0010). Adverse events included self-limited nausea and diarrhoea with no difference between the two groups. One patient in the control group discontinued lopinavir-ritonavir because of biochemical hepatitis. No patients died during the study.
INTERPRETATION


Early triple antiviral therapy was safe and superior to lopinavir-ritonavir alone in alleviating symptoms and shortening the duration of viral shedding and hospital stay in patients with mild to moderate COVID-19. Future clinical study of a double antiviral therapy with interferon beta-1b as a backbone is warranted.
FUNDING


The Shaw-Foundation, Richard and Carol Yu, May Tam Mak Mei Yin, and Sanming Project of Medicine.",2020,Adverse events included self-limited nausea and diarrhoea with no difference between the two groups.,"['patients with COVID-19', '127 patients were recruited; 86', 'adults with COVID-19 who were admitted to six hospitals in Hong Kong', 'Between Feb 10 and March 20, 2020', 'patients admitted to hospital with COVID-19', 'patients with mild to moderate COVID-19']","['lopinavir-ritonavir alone', 'lopinavir 400 mg and ritonavir', 'interferon beta-1b, lopinavir-ritonavir, and ribavirin', 'combined interferon beta-1b, lopinavir-ritonavir, and ribavirin', 'lopinavir 400 mg and ritonavir 100 mg every 12 h, ribavirin', 'lopinavir-ritonavir']","['self-limited nausea and diarrhoea', 'shorter median time', 'efficacy and safety', 'time to providing a nasopharyngeal swab negative for severe acute respiratory syndrome coronavirus 2 RT-PCR, and was done in the intention-to-treat population', 'duration of viral shedding and hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0244713', 'cui_str': 'interferon beta-1b'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0992889', 'cui_str': 'Ritonavir 100 MG'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",127.0,0.118203,Adverse events included self-limited nausea and diarrhoea with no difference between the two groups.,"[{'ForeName': 'Ivan Fan-Ngai', 'Initials': 'IF', 'LastName': 'Hung', 'Affiliation': 'Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China; State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Kwok-Cheung', 'Initials': 'KC', 'LastName': 'Lung', 'Affiliation': 'Department of Medicine, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Eugene Yuk-Keung', 'Initials': 'EY', 'LastName': 'Tso', 'Affiliation': 'Department of Medicine, United Christian Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine and Geriatrics, Ruttonjee Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Tom Wai-Hin', 'Initials': 'TW', 'LastName': 'Chung', 'Affiliation': 'Department of Microbiology, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Man-Yee', 'Initials': 'MY', 'LastName': 'Chu', 'Affiliation': 'Department of Medicine, Queen Elizabeth Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Yuk-Yung', 'Initials': 'YY', 'LastName': 'Ng', 'Affiliation': 'Department of Medicine, Tuen Mun Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Lo', 'Affiliation': 'Department of Medicine and Geriatrics, Ruttonjee Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Jacky', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, Princess Margaret Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Anthony Raymond', 'Initials': 'AR', 'LastName': 'Tam', 'Affiliation': 'Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Hoi-Ping', 'Initials': 'HP', 'LastName': 'Shum', 'Affiliation': 'Department of Intensive Care, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, United Christian Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Alan Ka-Lun', 'Initials': 'AK', 'LastName': 'Wu', 'Affiliation': 'Department of Microbiology, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Kit-Man', 'Initials': 'KM', 'LastName': 'Sin', 'Affiliation': 'Department of Medicine, Tuen Mun Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Wai-Shing', 'Initials': 'WS', 'LastName': 'Leung', 'Affiliation': 'Department of Medicine, Princess Margaret Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Wai-Lam', 'Initials': 'WL', 'LastName': 'Law', 'Affiliation': 'Department of Medicine, Queen Elizabeth Hospital, Hong Kong SAR, China.'}, {'ForeName': 'David Christopher', 'Initials': 'DC', 'LastName': 'Lung', 'Affiliation': 'Department of Microbiology, Queen Elizabeth Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Sin', 'Affiliation': 'Department of Intensive Care, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Yeung', 'Affiliation': 'Department of Intensive Care, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Cyril Chik-Yan', 'Initials': 'CC', 'LastName': 'Yip', 'Affiliation': 'Department of Microbiology, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Ricky Ruiqi', 'Initials': 'RR', 'LastName': 'Zhang', 'Affiliation': 'Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China; State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Agnes Yim-Fong', 'Initials': 'AY', 'LastName': 'Fung', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Erica Yuen-Wing', 'Initials': 'EY', 'LastName': 'Yan', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Kit-Hang', 'Initials': 'KH', 'LastName': 'Leung', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Jonathan Daniel', 'Initials': 'JD', 'LastName': 'Ip', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Allen Wing-Ho', 'Initials': 'AW', 'LastName': 'Chu', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Wan-Mui', 'Initials': 'WM', 'LastName': 'Chan', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Anthony Chin-Ki', 'Initials': 'AC', 'LastName': 'Ng', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'Department of Microbiology, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Kitty', 'Initials': 'K', 'LastName': 'Fung', 'Affiliation': 'Department of Microbiology, United Christian Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Alwin', 'Initials': 'A', 'LastName': 'Yeung', 'Affiliation': 'Department of Medicine and Geriatrics, Ruttonjee Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Tak-Chiu', 'Initials': 'TC', 'LastName': 'Wu', 'Affiliation': 'Department of Medicine, Queen Elizabeth Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Johnny Wai-Man', 'Initials': 'JW', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, Queen Elizabeth Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Wing-Wah', 'Initials': 'WW', 'LastName': 'Yan', 'Affiliation': 'Department of Intensive Care, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Wai-Ming', 'Initials': 'WM', 'LastName': 'Chan', 'Affiliation': 'Department of Intensive Care, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Jasper Fuk-Woo', 'Initials': 'JF', 'LastName': 'Chan', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Albert Kwok-Wai', 'Initials': 'AK', 'LastName': 'Lie', 'Affiliation': 'Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Owen Tak-Yin', 'Initials': 'OT', 'LastName': 'Tsang', 'Affiliation': 'Department of Medicine, Princess Margaret Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Vincent Chi-Chung', 'Initials': 'VC', 'LastName': 'Cheng', 'Affiliation': 'Department of Microbiology, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Tak-Lun', 'Initials': 'TL', 'LastName': 'Que', 'Affiliation': 'Department of Microbiology, Tuen Mun Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Chak-Sing', 'Initials': 'CS', 'LastName': 'Lau', 'Affiliation': 'Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Kwok-Hung', 'Initials': 'KH', 'LastName': 'Chan', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Kelvin Kai-Wang', 'Initials': 'KK', 'LastName': 'To', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Kwok-Yung', 'Initials': 'KY', 'LastName': 'Yuen', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China. Electronic address: kyyuen@hku.hk.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31042-4']
646,32401873,Skin picking treatment with the Rothbaum cognitive behavioral therapy protocol: a randomized clinical trial.,"INTRODUCTION


Although behavioral therapies can effectively treat skin picking disorder (SPD), there is no standardized treatment for improving SPD and its comorbidities and there is no group intervention option. This trial aimed to adapt the Rothbaum trichotillomania protocol to SPD (Study 1) and test its efficacy for treating SPD and comorbidities in individual and group formats (Study 2).
METHODS


The adapted protocol was applied to 16 SPD patients, who were allocated to group or individual treatment (Study 1). Afterwards, 54 patients were randomly allocated to treatment in an individual (n=27) or group format (n=27) (Study 2). In both studies, assessments of SPD severity, anxiety, depression, clinical status and skin lesion severity were performed at baseline and the endpoint.
RESULTS


The adapted protocol was feasible in both treatment modalities (Study 1) and led to high SPD remission rates (individual 63%; group 52%), with no significant difference between intervention types (p = 0.4) (Study 2). SPD, anxiety, and depression symptoms and objective patient lesion measures improved after treatment. There was large effect size for SPD symptom improvement in both treatment types (Cohen's d: group = 0.88; individual = 1.15) (Study 2).
CONCLUSION


The adapted Rothbaum protocol was effective for SPD remission, comorbidities, and skin lesions, both in individual and group formats.
CLINICAL TRIAL REGISTRATION


NCT03182478.",2020,"The adapted Rothbaum protocol was effective for SPD remission, comorbidities, and skin lesions, both in individual and group formats.
","['16 SPD patients', '54 patients were randomly allocated to treatment in an individual (n=27) or group format (n=27) ']",['Skin picking treatment with the Rothbaum cognitive behavioral therapy protocol'],"['SPD severity, anxiety, depression, clinical status and skin lesion severity', 'SPD symptom improvement', 'SPD, anxiety, and depression symptoms and objective patient lesion measures', 'SPD remission rates', 'SPD remission, comorbidities, and skin lesions']","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1301627', 'cui_str': 'Format'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0037284', 'cui_str': 'Skin lesion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1696701', 'cui_str': 'Dermatillomania'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",54.0,0.0387389,"The adapted Rothbaum protocol was effective for SPD remission, comorbidities, and skin lesions, both in individual and group formats.
","[{'ForeName': 'Alice C M', 'Initials': 'ACM', 'LastName': 'Xavier', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Camila M B', 'Initials': 'CMB', 'LastName': 'de Souza', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Luís H F', 'Initials': 'LHF', 'LastName': 'Flores', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Mariane B', 'Initials': 'MB', 'LastName': 'Bermudez', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Renata M F', 'Initials': 'RMF', 'LastName': 'Silva', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Ariadne C', 'Initials': 'AC', 'LastName': 'de Oliveira', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Carolina B', 'Initials': 'CB', 'LastName': 'Dreher', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}]","Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)",['10.1590/1516-4446-2019-0636']
647,32401905,Prevention of alcohol consumption and transmission of human immunodeficiency virus: randomized clinical trial.,"OBJECTIVE


to know the effects of a nursing intervention to reduce alcohol use and risk factors for transmission of human immunodeficiency virus (HIV).
METHOD


randomized single-blinded clinical trial performed by nurses with young women. The study included 66 participants in the intervention group and 66 participants in the control group. The instruments were the Alcohol Use Disorders Identification Test, the HIV Risk Behavior Knowledge and the Condom Use Self-efficacy Scale. Analysis of variance was used.
RESULTS


alcohol involvement decreased in the intervention group (F (1.119) = 50.28; p < 0.001; η2p = 0.297), while HIV knowledge (F (1.130) = 34.34; p < 0.001; η2p = 0.209) and condom use self-efficacy increased (F (1.129) = 27.20; p < 0.001; η2p = 0.174). In addition, less participants consumed alcohol in the past week compared to the control group (χ2 = 15.95; p < 0.001).
CONCLUSION


the nursing intervention had positive effects, which could help young women stay away from alcohol use and the risk of sexually transmitted infections. NCT: 02405481.",2020,"The instruments were the Alcohol Use Disorders Identification Test, the HIV Risk Behavior Knowledge and the Condom Use Self-efficacy Scale.","['human immunodeficiency virus', '66 participants in the intervention group and 66 participants in the control group', 'nurses with young women']","['NCT', 'nursing intervention']","['HIV knowledge', 'condom use self-efficacy', 'HIV Risk Behavior Knowledge and the Condom Use Self-efficacy Scale']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",66.0,0.0506514,"The instruments were the Alcohol Use Disorders Identification Test, the HIV Risk Behavior Knowledge and the Condom Use Self-efficacy Scale.","[{'ForeName': 'Martha Dalila', 'Initials': 'MD', 'LastName': 'Mendez-Ruiz', 'Affiliation': 'Facultad de Enfermería de Nuevo Laredo, Universidad Autónoma de Tamaulipas, Nuevo Laredo, Tamaulipas, Mexico.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Villegas-Pantoja', 'Affiliation': 'Facultad de Enfermería de Nuevo Laredo, Universidad Autónoma de Tamaulipas, Nuevo Laredo, Tamaulipas, Mexico.'}, {'ForeName': 'Nohemí Selene', 'Initials': 'NS', 'LastName': 'Alarcón-Luna', 'Affiliation': 'Facultad de Enfermería de Nuevo Laredo, Universidad Autónoma de Tamaulipas, Nuevo Laredo, Tamaulipas, Mexico.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Villegas', 'Affiliation': 'School of Nursing and Health Studies, University of Miami, Coral Gables, Florida, United States of America.'}, {'ForeName': 'Rosina', 'Initials': 'R', 'LastName': 'Cianelli', 'Affiliation': 'School of Nursing and Health Studies, University of Miami, Coral Gables, Florida, United States of America.'}, {'ForeName': 'Nilda', 'Initials': 'N', 'LastName': 'Peragallo-Montano', 'Affiliation': 'Chapel Hill School of Nursing, University of North Carolina, Chapel Hill, North Carolina, United States of America.'}]",Revista latino-americana de enfermagem,['10.1590/1518-8345.3393.3262']
648,32401935,Does use of silane-containing universal adhesive eliminate the need for silane application in direct composite repair?,"This in vitro study aimed to evaluate the effect of a silane-containing universal adhesive used with or without a silane agent on the repair bond strength between aged and new composites. Forty nanohybrid composite resin blocks were stored in distilled water for 14 d and thermo-cycled. Sandpaper ground, etched, and rinsed speciments were randomly assigned into four experimental groups: silane + two-step etch-and-rinse adhesive system, two-step etch-and-rinse adhesive system, silane + silane-containing universal adhesive system, and silane-containing universal adhesive system. Blocks were repaired using the same composite. After 24 h of water storage, the blocks were sectioned and bonded sticks were submitted to microtensile testing. Ten unaged, non-repaired composite blocks were used as a reference group to evaluate the cohesive strength of the composite. Two-way ANOVA and Tukey's tests were used to analyze average µTBS. One-way ANOVA and Dunnet post-hoc tests were used to compare the cohesive strength values and bond strength obtained in the repaired groups (α = 0.05). The µTBS values were higher for the silane-containing universal adhesive compared to the two-step etch-and-rinse adhesive system (p = 0.002). Silane application improved the repair bond strength (p = 0.03). The repair bond strength ranged from 39.3 to 65.8% of the cohesive strength of the reference group. Using universal silane-containing adhesive improved the repair bond strength of composite resin compared to two-step etch-and-rinse adhesive. However, it still required prior application of a silane agent for best direct composite resin repair outcomes.",2020,The repair bond strength ranged from 39.3 to 65.8% of the cohesive strength of the reference group.,['aged and new composites'],"['silane-containing universal adhesive used with or without a silane agent', 'silane + two-step etch-and-rinse adhesive system, two-step etch-and-rinse adhesive system, silane + silane-containing universal adhesive system, and silane-containing universal adhesive system']","['µTBS values', 'cohesive strength values and bond strength', 'repair bond strength', 'repair bond strength of composite resin']","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]","[{'cui': 'C0037093', 'cui_str': 'Silanes'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}]",40.0,0.0197588,The repair bond strength ranged from 39.3 to 65.8% of the cohesive strength of the reference group.,"[{'ForeName': 'Carolina Lopes da', 'Initials': 'CLD', 'LastName': 'Silva', 'Affiliation': 'Universidade Federal do Rio Grande do Sul - UFRS, School of Dentistry , Department of Surgery and Orthopedics , Porto Alegre , RS , Brazil .'}, {'ForeName': 'Maitê Munhoz', 'Initials': 'MM', 'LastName': 'Scherer', 'Affiliation': 'Universidade Federal do Rio Grande do Sul - UFRS, School of Dentistry , Post-Graduate Program in Pediatric Dentistry , Porto Alegre , RS , Brazil .'}, {'ForeName': 'Laura Teixeira', 'Initials': 'LT', 'LastName': 'Mendes', 'Affiliation': 'Universidade Federal do Rio Grande do Sul - UFRS, School of Dentistry , Post-Graduate Program in Pediatric Dentistry , Porto Alegre , RS , Brazil .'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Casagrande', 'Affiliation': 'Universidade Federal do Rio Grande do Sul - UFRS, School of Dentistry , Post-Graduate Program in Pediatric Dentistry , Porto Alegre , RS , Brazil .'}, {'ForeName': 'Vicente Castelo Branco', 'Initials': 'VCB', 'LastName': 'Leitune', 'Affiliation': 'Universidade Federal do Rio Grande do Sul - UFRS, School of Dentistry , Dental Materials Laboratory , Porto Alegre , RS , Brazil .'}, {'ForeName': 'Tathiane Larissa', 'Initials': 'TL', 'LastName': 'Lenzi', 'Affiliation': 'Universidade Federal do Rio Grande do Sul - UFRS, School of Dentistry , Post-Graduate Program in Pediatric Dentistry , Porto Alegre , RS , Brazil .'}]",Brazilian oral research,['10.1590/1807-3107bor-2020.vol34.0045']
649,32401941,Effect of music at 432 Hz and 440 Hz on dental anxiety and salivary cortisol levels in patients undergoing tooth extraction: a randomized clinical trial.,"Objective The aim of this study was to compare the effects of music at 432 Hz, 440 Hz, and no music on the clinical perception of anxiety and salivary cortisol levels in patients undergoing tooth extraction. Methodology A parallel-group randomized clinical trial was conducted. Forty-two patients (average age: 23.8±7.8 years, 27 women) with a moderate level of anxiety were distributed in three groups: use of music for 15 minutes at a frequency of 432 Hz (n=15), at 440 Hz (n=15) and a control group without music (n=12). The CORAH Dental Anxiety Scale and salivary cortisol levels, estimated by the solid phase enzyme-linked immunosorbent assay (ELISA), were measured and compared before and after the music intervention between groups (two-way ANOVA-Tukey p<0.05, RStudio). Results Significantly lower anxiety level values were observed at 432 Hz (8.7±2.67) and 440 Hz (8.4±2.84) compared to the control group (17.2±4.60; p<0.05). The salivary cortisol level at 432 Hz (0.49±0.37 μg/dL) was significantly lower than 440 Hz (1.35±0.69 μg/dL) and the control group (1.59±0.7 μg/dL; p<0.05). Conclusion The use of music significantly decreased clinical anxiety levels, and the frequency of 432 Hz was effective in decreasing salivary cortisol levels before tooth extraction.",2020,Results Significantly lower anxiety level values were observed at 432 Hz (8.7±2.67) and 440 Hz (8.4±2.84) compared to the control group (17.2±4.60; p<0.05).,"['Forty-two patients (average age: 23.8±7.8 years, 27 women) with a moderate level of anxiety', 'patients undergoing tooth extraction']","['control group without music', 'music at 432 Hz, 440 Hz, and no music', 'music at 432 Hz and 440 Hz']","['CORAH Dental Anxiety Scale and salivary cortisol levels, estimated by the solid phase enzyme-linked immunosorbent assay (ELISA', 'salivary cortisol level', 'clinical perception of anxiety and salivary cortisol levels', 'clinical anxiety levels', 'salivary cortisol levels', 'dental anxiety and salivary cortisol levels', 'anxiety level values']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C4517777', 'cui_str': '440'}]","[{'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",42.0,0.112363,Results Significantly lower anxiety level values were observed at 432 Hz (8.7±2.67) and 440 Hz (8.4±2.84) compared to the control group (17.2±4.60; p<0.05).,"[{'ForeName': 'Pedro Christian', 'Initials': 'PC', 'LastName': 'Aravena', 'Affiliation': 'Instituto de Anatomía, Histología y Patología, Facultad de Medicina, Universidad Austral de Chile, Valdivia, Chile.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Almonacid', 'Affiliation': 'Escuela de Odontología, Facultad de Medicina, Universidad Austral de Chile, Valdivia, Chile.'}, {'ForeName': 'Marcelo Ignacio', 'Initials': 'MI', 'LastName': 'Mancilla', 'Affiliation': 'Escuela de Odontología, Facultad de Medicina, Universidad Austral de Chile, Valdivia, Chile.'}]",Journal of applied oral science : revista FOB,['10.1590/1678-7757-2019-0601']
650,32401967,Posterior Capsule Opacification after Cataract Surgery in Children Over Five Years of Age with Square-edge Hydrophobic versus Hydrophilic Acrylic Intraocular Lenses: A Prospective Randomized Study.,"OBJECTIVE


To compare the effects of hydrophobic and hydrophilic materials in square-edged acrylic intraocular lenses (IOLs) on the development of posterior capsule opacification (PCO) after pediatric cataract surgery.
METHODS


Patients were randomly assigned to group 1 (hydrophobic acrylic square-edged IOLs; 13 eyes) or group 2 (hydrophilic acrylic square-edged IOLs; 13 eyes). The study evaluated PCO rates using Evaluation of Posterior Capsule Opacification (EPCO) 2000 software at one, three, six and 12 months postoperatively. Postoperative measurements also included corrected distance visual acuity (CDVA), neodymium:yttrium-aluminum-garnet (Nd:YAG) capsulotomy and postoperative complications other than PCO.
RESULTS


Both groups had significant increases in PCO rates after one year. Comparison of the groups showed no significant differences in the EPCO scores at three (group 1, 0.007±0.016 vs group 2, 0.008±0.014; p=0.830), six (group 1, 0.062±0.103 vs group 2, 0.021±0.023; p=0.184), or twelve months postoperatively (group 1, 0.200±0.193 vs group 2, 0.192±0.138; p=0.902). We also found no significant group differences regarding the change (delta, Δ) in EPCO scores between three and six months (group 1, 0.055±0.09 vs group 2, 0.013±0.02; p=0.113) or between six and twelve months postoperatively (group 1, 0.139±0.14 vs group 2, 0.171±0.14; p=0.567). Twenty-three percent of patients required Nd:YAG capsulotomy at the twelve-month visit.
CONCLUSIONS


No differences in PCO rates were found between hydrophobic and hydrophilic acrylic square-edged IOLs in children between five and twelve years of age at one year of follow-up.",2020,No differences in PCO rates were found between hydrophobic and hydrophilic acrylic square-edged IOLs in children between five and twelve years of age at one year of follow-up.,"['posterior capsule opacification (PCO) after pediatric cataract surgery', 'Children', 'Patients']","['acrylic intraocular lenses (IOLs', 'hydrophobic and hydrophilic materials', 'hydrophobic acrylic square-edged IOLs; 13 eyes) or group 2 (hydrophilic acrylic square-edged IOLs', 'Hydrophilic Acrylic Intraocular Lenses']","['corrected distance visual acuity (CDVA), neodymium:yttrium-aluminum-garnet', 'PCO rates', 'EPCO scores']","[{'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0598629', 'cui_str': 'Hydrophobicity'}, {'cui': 'C0475370', 'cui_str': 'Hydrophilic'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C1609285', 'cui_str': 'yttrium-aluminum-garnet'}, {'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0547806,No differences in PCO rates were found between hydrophobic and hydrophilic acrylic square-edged IOLs in children between five and twelve years of age at one year of follow-up.,"[{'ForeName': 'Camila Ribeiro', 'Initials': 'CR', 'LastName': 'Koch', 'Affiliation': 'Departamento de Oftalmologia, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Marcony R', 'Initials': 'MR', 'LastName': 'Santhiago', 'Affiliation': 'Departamento de Oftalmologia, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Priscilla A', 'Initials': 'PA', 'LastName': 'Jorge', 'Affiliation': 'Departamento de Oftalmologia, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Sena', 'Affiliation': 'Hospital Humberto Castro Lima, Salvador, BA, BR.'}, {'ForeName': 'Newton', 'Initials': 'N', 'LastName': 'Kara-Júnior', 'Affiliation': 'Departamento de Oftalmologia, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}]","Clinics (Sao Paulo, Brazil)",['10.6061/clinics/2020/e1604']
651,32402060,Obesity and weight loss are inversely related to mortality and cardiovascular outcome in prediabetes and type 2 diabetes: data from the ORIGIN trial.,"AIMS


The association of body weight and weight change with mortality and cardiovascular (CV) outcome in patients with diabetes mellitus (DM) is not clearly established. We assessed the relationship between weight, weight change, and outcomes in patients with established CV risk factors and type 2 DM or pre-diabetes.
METHODS AND RESULTS


A total of 12 521 participants from the ORIGIN trial were grouped in BMI categories of low body weight [body mass index (BMI) < 22 kg/m2] normal (22-24.9), overweight (25-29.9), obesity Grades 1-3 (30-34.9, 35-39.9, ≥40 kg/m2, respectively). Outcome variables included total and CV mortality and composite outcomes of CV death, non-fatal stroke, or myocardial infarction plus revascularization or heart failure hospitalization. Follow-up was 6.2 years (interquartile range 5.8-6.7 years). After multivariable adjustment, lowest risks were seen in patients with overweight and mild obesity for total mortality [overweight: hazard ratio (HR) 0.80 (95% confidence interval (CI) 0.69-0.91); obesity Grade 1: HR 0.82 (0.71-0.95), both P < 0.01)] and CV mortality [overweight: HR 0.79 (0.66-0.94); obesity Grade 1: 0.79 (0.65-0.95), all compared to patients with normal BMI, P < 0.05]. Obesity of any severity was not associated with higher mortality. Low body weight was related to higher mortality [HR 1.28 (1.02-1.61); CV mortality: HR 1.34 (1.01-1.79), P < 0.05]. A continued 2-year weight loss was associated with higher risk of mortality [HR 1.32 (1.18-1.46), P < 0.0001] and CV mortality [HR 1.18 (1.02-1.35), compared to patients without weight loss, P < 0.05]. In turn, weight gain was not related to any adverse outcome.
CONCLUSION


Obesity in patients with DM or pre-diabetes and CV risk profile was not associated with higher mortality or adverse CV outcome. The lowest mortality risk was seen in patients with overweight and moderate obesity (BMI 25-35 kg/m2). Weight loss was an independent risk factor for higher mortality compared to no weight loss.",2020,The lowest mortality risk was seen in patients with overweight and moderate obesity (BMI 25-35 kg/m2).,"['patients with diabetes mellitus (DM', 'A total of 12 521 participants from the ORIGIN trial were grouped in BMI categories of low body weight [body mass index (BMI)\u2009<\u200922 kg/m2] normal (22-24.9), overweight (25-29.9), obesity Grades 1-3 (30-34.9, 35-39.9, ≥40\u2009kg/m2, respectively', 'patients with established CV risk factors and type 2 DM or pre-diabetes']",[],"['body weight and weight change with mortality and cardiovascular (CV) outcome', 'Weight loss', '2-year weight loss', 'weight gain', 'Obesity and weight loss', 'CV mortality', 'total and CV mortality and composite outcomes of CV death, non-fatal stroke, or myocardial infarction plus revascularization or heart failure hospitalization', 'mortality or adverse CV outcome', 'Low body weight', 'lowest mortality risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]",[],"[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",12521.0,0.0708303,The lowest mortality risk was seen in patients with overweight and moderate obesity (BMI 25-35 kg/m2).,"[{'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Doehner', 'Affiliation': 'Berlin Institute of Health Center for Regenerative Therapies (BCRT), Charité Universitätsmedizin Berlin, 13353 Berlin, Germany.'}, {'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, L8S 4K1 Hamilton, ON, Canada.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Ried', 'Affiliation': 'Sanofi-Aventis Deutschland GmbH, Research & Development, 65926 Frankfurt, Germany.'}, {'ForeName': 'Hyejung', 'Initials': 'H', 'LastName': 'Jung', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, L8S 4K1 Hamilton, ON, Canada.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Asbrand', 'Affiliation': 'Sanofi-Aventis Deutschland GmbH, Research & Development, 65926 Frankfurt, Germany.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Hess', 'Affiliation': 'Sanofi-Aventis Deutschland GmbH, Research & Development, 65926 Frankfurt, Germany.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Berlin Institute of Health Center for Regenerative Therapies (BCRT), Charité Universitätsmedizin Berlin, 13353 Berlin, Germany.'}]",European heart journal,['10.1093/eurheartj/ehaa293']
652,32402161,Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis.,"BACKGROUND


Bacterial vaginosis affects 15 to 50% of women of reproductive age, and recurrence is common after treatment with an antibiotic agent. The high incidence of recurrence suggests the need for new treatments to prevent recurrent bacterial vaginosis.
METHODS


We conducted a randomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of  Lactobacillus crispatus  CTV-05 (Lactin-V) to prevent the recurrence of bacterial vaginosis. Women 18 to 45 years of age who had received a diagnosis of bacterial vaginosis and who had completed a course of vaginal metronidazole gel as part of the eligibility requirements were randomly assigned, in a 2:1 ratio, to receive vaginally administered Lactin-V or placebo for 11 weeks; follow-up occurred through week 24. The primary outcome was the percentage of women who had a recurrence of bacterial vaginosis by week 12.
RESULTS


A total of 228 women underwent randomization: 152 to the Lactin-V group and 76 to the placebo group; of these participants, 88% in the Lactin-V group and 84% in the placebo group could be evaluated for the primary outcome. In the intention-to-treat population, recurrence of bacterial vaginosis by week 12 occurred in 46 participants (30%) in the Lactin-V group and in 34 participants (45%) in the placebo group (risk ratio after multiple imputation for missing responses, 0.66; 95% confidence interval [CI], 0.44 to 0.87; P = 0.01). The risk ratio for recurrence by week 24 (also calculated with multiple imputation for missing responses) was 0.73 (95% CI, 0.54 to 0.92). At the 12-week visit,  L. crispatus  CTV-05 was detected in 79% of participants in the Lactin-V group. The percentage of participants who had at least one adverse event related to Lactin-V or placebo by week 24 did not differ significantly between the groups. The percentage of participants with local or systemic adverse events was similar in the two groups.
CONCLUSIONS


The use of Lactin-V after treatment with vaginal metronidazole resulted in a significantly lower incidence of recurrence of bacterial vaginosis than placebo at 12 weeks. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT02766023.).",2020,"At the 12-week visit,  L. crispatus  CTV-05 was detected in 79% of participants in the Lactin-V group.","['228 women underwent randomization: 152 to the Lactin-V group and 76 to the', 'Women 18 to 45 years of age who had received a diagnosis of bacterial vaginosis and who had completed a course of vaginal metronidazole gel as part of the eligibility requirements']","['vaginal metronidazole', 'vaginally administered Lactin-V or placebo', 'Lactobacillus crispatus  CTV-05 (Lactin-V', 'Lactin-V', 'placebo']","['recurrence of bacterial vaginosis', 'risk ratio for recurrence', 'percentage of women who had a recurrence of bacterial vaginosis', 'percentage of participants with local or systemic adverse events', 'Recurrence of Bacterial Vaginosis']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0595096', 'cui_str': 'Metronidazole-containing product in vaginal dose form'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0595096', 'cui_str': 'Metronidazole-containing product in vaginal dose form'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0317614', 'cui_str': 'Lactobacillus crispatus'}, {'cui': 'C0454198', 'cui_str': 'Clinical target volume'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",228.0,0.642452,"At the 12-week visit,  L. crispatus  CTV-05 was detected in 79% of participants in the Lactin-V group.","[{'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Cohen', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Wierzbicki', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Audrey L', 'Initials': 'AL', 'LastName': 'French', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Newmann', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Reno', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Green', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Miller', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Powell', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Parks', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Hemmerling', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}]",The New England journal of medicine,['10.1056/NEJMoa1915254']
653,32207048,"Effect of the ""Recruitment"" Maneuver on Respiratory Mechanics in Laparoscopic Sleeve Gastrectomy Surgery.","PURPOSE


LSG surgery is used for surgical treatment of morbid obesity. Obesity, anesthesia, and pneumoperitoneum cause reduced pulmoner functions and a tendency for atelectasis. The alveolar ""recruitment"" maneuver (RM) keeps airway pressure high, opening alveoli, and increasing arterial oxygenation. The aim of our study is to research the effect on respiratory mechanics and arterial blood gases of performing the RM in LSG surgery.
MATERIALS AND METHODS


Sixty patients undergoing LSG surgery were divided into two groups (n = 30) Patients in group R had the RM performed 5 min after desufflation with 100% oxygen, 40 cmH 2 O pressure for 40 s. Group C had standard mechanical ventilation. Assessments of respiratory mechanics and arterial blood gases were made in the 10th min after induction (T1), 10th min after insufflation (T2), 5th min after desufflation (T3), and 15th min after desufflation (T4). Arterial blood gases were assessed in the 30th min (T5) in the postoperative recovery unit.
RESULTS


In group R, values at T5, PaO 2  were significantly high, while PaCO 2  were significantly low compared with group C. Compliance in both groups reduced with pneumoperitoneum. At T4, the compliance in the recruitment group was higher. In both groups, there was an increase in PIP with pneumoperitoneum and after desufflation this was identified to reduce to levels before pneumoperitoneum.
CONCLUSION


Adding the RM to PEEP administration for morbidly obese patients undergoing LSG surgery is considered to be effective in improving respiratory mechanics and arterial blood gas values and can be used safely.",2020,"In group R, values at T5, PaO 2  were significantly high, while PaCO 2  were significantly low compared with group C. Compliance in both groups reduced with pneumoperitoneum.","['morbidly obese patients undergoing LSG surgery', 'Laparoscopic Sleeve Gastrectomy Surgery', 'Sixty patients undergoing LSG surgery']","['RM performed 5\xa0min after desufflation with 100% oxygen, 40\xa0cmH 2 O pressure for 40\xa0s. Group C had standard mechanical ventilation', 'Recruitment"" Maneuver']","['Arterial blood gases', 'respiratory mechanics and arterial blood gases', 'PIP with pneumoperitoneum', 'Respiratory Mechanics', 'respiratory mechanics and arterial blood gas values']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}]","[{'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",60.0,0.0255194,"In group R, values at T5, PaO 2  were significantly high, while PaCO 2  were significantly low compared with group C. Compliance in both groups reduced with pneumoperitoneum.","[{'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Sümer', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey. isumer@bezmialem.edu.tr.'}, {'ForeName': 'Ufuk', 'Initials': 'U', 'LastName': 'Topuz', 'Affiliation': 'Health Cares Vocational School, İstanbul Esenyurt University, Istanbul, Turkey.'}, {'ForeName': 'Selçuk', 'Initials': 'S', 'LastName': 'Alver', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, İstanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'Tarik', 'Initials': 'T', 'LastName': 'Umutoglu', 'Affiliation': 'İstanbul Acıbadem Taksim Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mefkur', 'Initials': 'M', 'LastName': 'Bakan', 'Affiliation': 'Health Cares Vocational School, İstanbul Esenyurt University, Istanbul, Turkey.'}, {'ForeName': 'Seniyye Ülgen', 'Initials': 'SÜ', 'LastName': 'Zengin', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Halil', 'Initials': 'H', 'LastName': 'Coşkun', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Ziya', 'Initials': 'Z', 'LastName': 'Salihoglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Cerrahpasa Faculty of Medicine, İstanbul University Cerrahpasa, Istanbul, Turkey.'}]",Obesity surgery,['10.1007/s11695-020-04551-y']
654,32401106,Effect of elastic abdominal binder on pain and functional recovery after caesarean delivery: a randomised controlled trial.,"The Elastic abdominal binder has been widely employed by clinicians for pain relief, wound complications prevention, improved pulmonary function, and stabilisation. However, these proposed benefits have not been properly examined in women following caesarean delivery. We aimed to examine the effects of post-caesarean elastic abdominal binder use on recovery by comparing post-operative pain, mobility and quality of life. Pregnant women undergoing caesarean delivery were randomly assigned into two groups: abdominal binder (90 patients) and control (90 patients). The primary outcomes included the daily visual analogue scale pain scores and the distance from the six-minute walk test. Baseline characteristics were similar between the groups. There was no significant difference in pain scores and six-minute walking distance between the study groups. There was no significant between-group difference in quality-of-life dimensions, overall health status, and post-operative complication. The positive effects of elastic abdominal binder use following caesarean delivery could not be demonstrated in this study.Impact statement What is already known on this subject?  Elastic abdominal binder is commonly used after laparotomy to support incision. There was evidence to support the benefit of abdominal binder in reducing psychological distress during the first five days following laparotomy for other indications. From limited number of studies addressing caesarean section, the evidence for the benefits of the binder on pain, symptom distress, and change in haemoglobin level is conflicting. What do the results of this study add?  In contrast to the results of the previous study, the beneficial effects of abdominal binder on pain reduction, functional recovery, and quality of life following caesarean delivery could not be demonstrated in this study. What are the implications of these findings for clinical practice and/or further research?  The use of elastic abdominal binder after caesarean delivery is not associated with reduction of postoperative pain, faster functional recovery, and improved quality of life in our population. Further studies in other population with different characteristics may be worthwhile.",2020,"The use of elastic abdominal binder after caesarean delivery is not associated with reduction of postoperative pain, faster functional recovery, and improved quality of life in our population.","['Pregnant women undergoing caesarean delivery', 'after caesarean delivery']","['elastic abdominal binder', 'abdominal binder']","['pain reduction, functional recovery, and quality of life', 'quality of life', 'operative pain, mobility and quality of life', 'quality-of-life dimensions, overall health status, and post-operative complication', 'daily visual analogue scale pain scores and the distance from the six-minute walk test', 'pain and functional recovery', 'psychological distress', 'pain scores and six-minute walking distance']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0179303', 'cui_str': 'Abdominal binder'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.188427,"The use of elastic abdominal binder after caesarean delivery is not associated with reduction of postoperative pain, faster functional recovery, and improved quality of life in our population.","[{'ForeName': 'Wisit', 'Initials': 'W', 'LastName': 'Chankhunaphas', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Kittipat', 'Initials': 'K', 'LastName': 'Charoenkwan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2019.1631768']
655,32401221,A Mobile Health App for the Collection of Functional Outcomes After Inpatient Stroke Rehabilitation: Pilot Randomized Controlled Trial.,"BACKGROUND


Monitoring the functional status of poststroke patients after they transition home is significant for rehabilitation. Mobile health (mHealth) technologies may provide an opportunity to reach and follow patients post discharge. However, the feasibility and validity of functional assessments administered by mHealth technologies are unknown.
OBJECTIVE


This study aimed to evaluate the feasibility, validity, and reliability of functional assessments administered through the videoconference function of a mobile phone-based app compared with administration through the telephone function in poststroke patients after rehabilitation hospitalization.
METHODS


A randomized controlled trial was conducted in a rehabilitation hospital in Southeast China. Participants were randomly assigned to either a videoconference follow-up (n=60) or a telephone follow-up (n=60) group. We measured the functional status of participants in each group at 2-week and 3-month follow-up periods. Half the participants in each group were followed by face-to-face home visit assessments as the gold standard. Validity was assessed by comparing any score differences between videoconference follow-up and home visit assessments, as well as telephone follow-up and home visit assessments. Reliability was assessed by computing agreements between videoconference follow-up and home visit assessments, as well as telephone follow-up and home visit assessments. Feasibility was evaluated by the levels of completion, satisfaction, comfort, and confidence in the 2 groups.
RESULTS


Scores obtained from the videoconference follow-up were similar to those of the home visit assessment. However, most scores collected from telephone administration were higher than those of the home visit assessment. The agreement between videoconference follow-up and home visit assessments was higher than that between telephone follow-up and home visit assessments at all follow-up periods. In the telephone follow-up group, completion rates were 95% and 82% at 2-week and 3-month follow-up points, respectively. In the videoconference follow-up group, completion rates were 95% and 80% at 2-week and 3-month follow-up points, respectively. There were no differences in the completion rates between the 2 groups at all follow-up periods (X 2 1 =1.6, P=.21 for 2-week follow-up; X 2 1 =1.9, P=.17 for 3-month follow-up). Patients in the videoconference follow-up group perceived higher confidence than those in the telephone follow-up group at both 2-week and 3-month follow-up periods (X 2 3 =6.7, P=.04 for 2-week follow-up; X 2 3 =8.0, P=.04 for 3-month follow-up). The videoconference follow-up group demonstrated higher satisfaction than the telephone follow-up group at 3-month follow-up (X 2 3 =13.9; P=.03).
CONCLUSIONS


The videoconference follow-up assessment of functional status demonstrates higher validity and reliability, as well as higher confidence and satisfaction perceived by patients, than the telephone assessment. The videoconference assessment provides an efficient means of assessing functional outcomes of patients after hospital discharge. This method provides a novel solution for clinical trials requiring longitudinal assessments.
TRIAL REGISTRATION


chictr.org.cn: ChiCTR1900027626; http://www.chictr.org.cn/edit.aspx?pid=44831&htm=4.",2020,"Patients in the videoconference follow-up group perceived higher confidence than those in the telephone follow-up group at both 2-week and 3-month follow-up periods (X 2 3 =6.7, P=.04 for 2-week follow-up; X 2 3 =8.0, P=.04 for 3-month follow-up).","['patients after hospital discharge', 'rehabilitation hospital in Southeast China', 'poststroke patients after rehabilitation hospitalization']","['videoconference follow-up (n=60) or a telephone follow-up', 'mobile phone-based app compared with administration through the telephone function']","['Reliability', 'completion rates', 'higher satisfaction', 'levels of completion, satisfaction, comfort, and confidence', 'higher confidence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0031843', 'cui_str': 'PH'}]","[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.0461705,"Patients in the videoconference follow-up group perceived higher confidence than those in the telephone follow-up group at both 2-week and 3-month follow-up periods (X 2 3 =6.7, P=.04 for 2-week follow-up; X 2 3 =8.0, P=.04 for 3-month follow-up).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Jingsong', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Cai', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Shanjia', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Guanli', 'Initials': 'G', 'LastName': 'Xie', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Jinxin', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Chetwyn C H', 'Initials': 'CCH', 'LastName': 'Chan', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, HongKong, Hong Kong.'}, {'ForeName': 'Lidian', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Alex W K', 'Initials': 'AWK', 'LastName': 'Wong', 'Affiliation': 'Program in Occupational Therapy, Washington University School of Medicine, St. Louis, MO, United States.'}]",JMIR mHealth and uHealth,['10.2196/17219']
656,32401225,Social Media Interventions for Risky Drinking Among Adolescents and Emerging Adults: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Despite intervention efforts to date, the prevalence of risky drinking among adolescents and emerging adults remains high, increasing the risk for health consequences and the development of alcohol use disorders. Peer influences are particularly salient among this age group, including via social media. Thus, the development of efficacious early interventions for youth, delivered with a broad reach via trained peers on social media, could have an important role in addressing risky drinking and concomitant drug use.
OBJECTIVE


This paper describes the protocol of a randomized controlled trial (RCT) testing the efficacy of a social media intervention among adolescents and emerging adults who meet the criteria for risky drinking (using the Alcohol Use Disorders Identification Test-Consumption [AUDIT-C]), delivered with and without financial incentives for participation, compared with an attention placebo control condition (ie, entertaining social media content), on alcohol consumption and consequences.
METHODS


This RCT involved recruiting 955 youths (aged 16-24 years) via advertisements on Facebook and Instagram to self-administer a brief web-based screening survey. Those screening positive for past 3-month risky drinking (AUDIT-C positive: ages 16-17 years: ≥3 females and ≥4 males; and ages 18-24 years: ≥4 females and ≥5 males) were eligible for the RCT. After providing consent (a waiver of parental consent was obtained for minors), participants completed a web-based baseline survey and several verification procedures, including a selfie photo matched to Facebook profile photos. Participants were then randomized to join invitation-only secret Facebook groups, which were not searchable or viewable by parents, friends, or anyone not recruited by the study. The 3 conditions were social media intervention with incentives, social media intervention without incentives (SMI), and attention placebo control. Each condition lasted 8 weeks and consisted of bachelor's-level and master's-level therapist electronic coaches posting relevant content and responding to participants' posts in a manner consistent with Motivational Interviewing. Participants in the control condition and SMI condition did not receive payments but were blind to condition assignment between these 2 conditions. Follow-ups are ongoing and occur at 3, 6, and 12 months poststart of the groups.
RESULTS


We enrolled 955 participants over 10 waves of recruitment who screened positive for risky drinking into the RCT.
CONCLUSIONS


The findings of this study will provide the critical next step in delivering early alcohol interventions to the youth, capitalizing on social media platforms, which could have significant public health impact by altering alcohol use trajectories of adolescents and emerging adults engaged in risky drinking.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02809586; https://clinicaltrials.gov/ct2/show/NCT02809586.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/16688.",2020,Participants in the control condition and SMI condition did not receive payments but were blind to condition assignment between these 2 conditions.,"['955 youths (aged 16-24 years) via advertisements on Facebook and Instagram to self-administer a brief web-based screening survey', 'Risky Drinking Among Adolescents and Emerging Adults', '955 participants over 10 waves of recruitment who screened positive for risky drinking into the RCT', 'Those screening positive for past 3-month risky drinking (AUDIT-C positive: ages 16-17 years: ≥3 females and ≥4 males; and ages 18-24 years: ≥4 females and ≥5 males', 'adolescents and emerging adults who meet the criteria for risky drinking (using the Alcohol Use Disorders Identification Test-Consumption [AUDIT-C']","['Social Media Interventions', ""bachelor's-level and master's-level therapist electronic coaches posting relevant content and responding to participants' posts in a manner consistent with Motivational Interviewing"", 'social media intervention with incentives, social media intervention without incentives (SMI), and attention placebo control', 'social media intervention']",[],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0337600', 'cui_str': 'Bachelor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],955.0,0.0843012,Participants in the control condition and SMI condition did not receive payments but were blind to condition assignment between these 2 conditions.,"[{'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Bonar', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Diane M', 'Initials': 'DM', 'LastName': 'Schneeberger', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Bourque', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Bauermeister', 'Affiliation': 'Department of Family and Community Health, School of Nursing, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Young', 'Affiliation': 'Department of Informatics, Donald Bren School of Information and Computer Sciences, University of California Irvine, Irvine, CA, United States.'}, {'ForeName': 'Frederic C', 'Initials': 'FC', 'LastName': 'Blow', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Cunningham', 'Affiliation': 'Injury Prevention Center, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Amy Sb', 'Initials': 'AS', 'LastName': 'Bohnert', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Zimmerman', 'Affiliation': 'Injury Prevention Center, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Maureen A', 'Initials': 'MA', 'LastName': 'Walton', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States.'}]",JMIR research protocols,['10.2196/16688']
657,32402688,Comparison of two strategies in a chest pain unit: stress echocardiography and multidetector computed tomography.,"INTRODUCTION AND OBJECTIVES


This study aimed to compare stress echocardiography (SE) and multidetector computed tomography (MCT) in patients admitted to a chest pain unit to detect acute coronary syndrome (ACS).
METHODS


A total of 203 patients with ≥ 1 cardiovascular risk factor, no ischemic electrocardiogram changes and negative biomarkers were randomized to SE (n=103) or MTC (n=100). The primary endpoint was a combination of hard events (death and nonfatal myocardial infarction), revascularizations, and readmissions during follow-up. The secondary endpoint was the cost of the 2 strategies.
RESULTS


Invasive angiography was performed in 61 patients (34 [33%] in the SE group and in 27 [27%] in the MCT group, P=.15). A final diagnosis of ACS was made in 53 patients (88% vs 85%, P=.35). There were no significant differences between groups in the primary endpoint (42% vs 41%, P=.91), or in hard events (5% vs 7%, P=.42). There were no significant differences in overall cost, but costs were lower in patients with negative SE than in those with negative MCT (€557 vs €706, P <.02).
CONCLUSIONS


No significant differences were found in efficacy and safety for the stratification of patients with a low to moderate probability of ACS admitted to a chest pain unit. The cost of the 2 strategies was similar, but cost was significantly lower for SE on comparison of negative studies.",2020,"There were no significant differences between groups in the primary endpoint (42% vs 41%, P=.91), or in hard events (5% vs 7%, P=.42).","['203 patients with ≥ 1 cardiovascular risk factor, no ischemic electrocardiogram changes and negative biomarkers', 'patients admitted to a chest pain unit to detect acute coronary syndrome (ACS']","['SE', 'stress echocardiography (SE) and multidetector computed tomography (MCT', 'MTC', 'echocardiography and multidetector computed tomography']","['combination of hard events (death and nonfatal myocardial infarction), revascularizations, and readmissions during follow-up', 'efficacy and safety', 'overall cost, but costs', 'cost of the 2 strategies']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0855329', 'cui_str': 'Electrocardiogram change'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C0920208', 'cui_str': 'Stress echocardiogram'}, {'cui': 'C3179130', 'cui_str': 'Multidetector-Row Computed Tomography'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}]","[{'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",203.0,0.0226386,"There were no significant differences between groups in the primary endpoint (42% vs 41%, P=.91), or in hard events (5% vs 7%, P=.42).","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Piñeiro-Portela', 'Affiliation': 'Unidad de Imagen Cardiaca, Servicio de Cardiología, Hospital Universitario A Coruña (CHUAC), Instituto de Investigación Biomédica de A Coruña (INIBIC), A Coruña, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain. Electronic address: mpinpor@secardiologia.es.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Peteiro-Vázquez', 'Affiliation': 'Unidad de Imagen Cardiaca, Servicio de Cardiología, Hospital Universitario A Coruña (CHUAC), Instituto de Investigación Biomédica de A Coruña (INIBIC), A Coruña, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bouzas-Mosquera', 'Affiliation': 'Unidad de Imagen Cardiaca, Servicio de Cardiología, Hospital Universitario A Coruña (CHUAC), Instituto de Investigación Biomédica de A Coruña (INIBIC), A Coruña, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Martínez-Ruiz', 'Affiliation': 'Unidad de Imagen Cardiaca, Servicio de Cardiología, Hospital Universitario A Coruña (CHUAC), Instituto de Investigación Biomédica de A Coruña (INIBIC), A Coruña, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Yañez-Wonenburger', 'Affiliation': 'Unidad de Imagen Cardiaca, Servicio de Cardiología, Hospital Universitario A Coruña (CHUAC), Instituto de Investigación Biomédica de A Coruña (INIBIC), A Coruña, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Pombo', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain; Servicio de Radiología, Hospital Universitario de A Coruña, A Coruña, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Vázquez-Rodríguez', 'Affiliation': 'Unidad de Imagen Cardiaca, Servicio de Cardiología, Hospital Universitario A Coruña (CHUAC), Instituto de Investigación Biomédica de A Coruña (INIBIC), A Coruña, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.'}]",Revista espanola de cardiologia (English ed.),['10.1016/j.rec.2020.01.023']
658,32402702,Pragmatic trial comparing routine versus no routine functional testing in high-risk patients who underwent percutaneous coronary intervention: Rationale and design of POST-PCI trial.,"BACKGROUND


Although the need to detect restenosis has diminished in the contemporary practice of percutaneous coronary intervention (PCI) with drug-eluting stents (DES), the surveillance of ischemia owing to restenosis or disease progression deserves attention in high-risk PCI settings. It is unknown whether follow-up strategy of routine noninvasive functional testing potentially reduces the risk of major cardiovascular events in high-risk PCI patients.
METHODS


The POST-PCI study is an investigator-initiated, multicenter, prospective randomized trial comparing the effectiveness of two follow-up strategies in patients with high-risk anatomic or clinical characteristics who underwent PCI. Study participants were randomly assigned to either (1) the routine noninvasive stress testing (exercise electrocardiography, nuclear stress imaging, or stress echocardiography) at 12 months post-PCI or (2) the standard-care without routine testing. In the routine stress testing group, depending on the testing results, all clinical decisions regarding subsequent diagnostic or therapeutic procedures were at the treating physician's discretion. The primary endpoint was a composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI.
RESULTS


More than 1700 high-risk PCI patients have been randomized over 2.0 years at 11 major cardiac centers in Korea.
CONCLUSION


This pragmatic POST-PCI trial will provide valuable clinical evidence on the effectiveness of follow-up strategy of routine noninvasive stress testing in high-risk PCI patients.",2020,"The primary endpoint was a composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI.
","['high-risk PCI patients', 'high-risk patients who underwent percutaneous coronary intervention', 'patients with high-risk anatomic or clinical characteristics who underwent PCI', '1700 high-risk PCI patients']","['routine noninvasive stress testing (exercise electrocardiography, nuclear stress imaging, or stress echocardiography) at 12 months post-PCI or (2) the standard-care without routine testing', 'routine versus no routine functional testing', 'percutaneous coronary intervention (PCI) with drug-eluting stents (DES']","['composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0920208', 'cui_str': 'Stress echocardiogram'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0562340', 'cui_str': 'Poor daily routine'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]",,0.0929061,"The primary endpoint was a composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI.
","[{'ForeName': 'Yong-Hoon', 'Initials': 'YH', 'LastName': 'Yoon', 'Affiliation': 'Division of Cardiology, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Do-Yoon', 'Initials': 'DY', 'LastName': 'Kang', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hanbit', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang-Cheol', 'Initials': 'SC', 'LastName': 'Cho', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Pil Hyung', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Ho', 'Initials': 'SH', 'LastName': 'Hur', 'Affiliation': 'Division of Cardiology, Keimyung University Dongsan Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Won-Jang', 'Initials': 'WJ', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea.'}, {'ForeName': 'Chul Soo', 'Initials': 'CS', 'LastName': 'Park', 'Affiliation': ""Cardiovascular Center and Cardiology Division, Yeouido St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Bong-Ki', 'Initials': 'BK', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Kangwon National University Hospital, Chuncheon, Republic of Korea.'}, {'ForeName': 'Jung-Won', 'Initials': 'JW', 'LastName': 'Suh', 'Affiliation': 'Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Jung Han', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Division of Cardiology, Wonju Christian Hospital, Wonju, Republic of Korea.'}, {'ForeName': 'Jae Woong', 'Initials': 'JW', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Eulji General Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Ki-Sik', 'Initials': 'KS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Catholic University of Daegu, Daegu, Republic of Korea.'}, {'ForeName': 'Si Wan', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Su Nam', 'Initials': 'SN', 'LastName': 'Lee', 'Affiliation': ""Division of Cardiology, St. Vincent's Hospital, The Catholic University of Korea, Suwon, Republic of Korea.""}, {'ForeName': 'Seung-Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Duk-Woo', 'Initials': 'DW', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. Electronic address: dwpark@amc.seoul.kr.'}]",American heart journal,['10.1016/j.ahj.2020.03.019']
659,32402732,Transversus abdominis plane block with liposomal bupivacaine and its effect on opiate use after weight loss surgery: a randomized controlled trial.,"BACKGROUND


Liposomal bupivacaine (LB), as an extended-release local anesthetic, may provide lasting pain control and therefore decrease the need for narcotics in the immediate postoperative period.
OBJECTIVES


The aim of this study was to evaluate whether transversus abdominis plane (TAP) block with LB decreased the use of postoperative narcotics compared with regular bupivacaine (RB) and no TAP block in patients undergoing weight loss procedures.
SETTING


A large, metropolitan, university-affiliated, tertiary hospital.
METHODS


Patients undergoing laparoscopic Roux-en-Y gastric bypass, sleeve gastrectomy, or sleeve-to-bypass conversion over 1 year were randomized to receive TAP block using LB, TAP block with RB, or no block in a double-blind, randomized controlled trial. The outcomes measured were postoperative use of opiates, pain score, length of stay, time to ambulation, and nausea. Data were analyzed using χ 2  test and analysis of variance F test.
RESULTS


Two hundred nineteen patients were included in the study. Fentanyl patient-controlled analgesia usage was not significantly different between the groups (LB 351.4 versus RB 360.7 versus no TAP block 353.9, P = .97) at 48 hours post operation. The pain scores (scale 1-10) were similar among the groups with the mean for the LB group at 4.3, and RB and no TAP block groups both at 4.7 (P = .35). The type of block or lack of block did not significantly impact the length of stay, time to ambulation, or presence of nausea.
CONCLUSION


The LB TAP block did not significantly reduce the total opiate pain medication consumption nor did it reduce pain scores among bariatric surgery patients.",2020,The LB TAP block did not significantly reduce the total opiate pain medication consumption nor did it reduce pain scores among bariatric surgery patients.,"['A large, metropolitan, university-affiliated, tertiary hospital', 'opiate use after weight loss surgery', 'patients undergoing weight loss procedures', 'Two hundred nineteen patients were included in the study', 'Patients undergoing laparoscopic Roux-en-Y gastric bypass, sleeve gastrectomy, or sleeve-to-bypass conversion over 1 year']","['transversus abdominis plane (TAP) block with LB', 'regular bupivacaine (RB) and no TAP block', 'Liposomal bupivacaine (LB', 'TAP block using LB, TAP block with RB, or no block', 'liposomal bupivacaine']","['Fentanyl patient-controlled analgesia usage', 'pain scores', 'length of stay, time to ambulation, or presence of nausea', 'postoperative use of opiates, pain score, length of stay, time to ambulation, and nausea', 'total opiate pain medication consumption']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",219.0,0.208823,The LB TAP block did not significantly reduce the total opiate pain medication consumption nor did it reduce pain scores among bariatric surgery patients.,"[{'ForeName': 'Kristen A', 'Initials': 'KA', 'LastName': 'Wong', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Ana Garcia', 'Initials': 'AG', 'LastName': 'Cabrera', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Argiroff', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Pechman', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Parides', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York; Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Joseph T', 'Initials': 'JT', 'LastName': 'Vazzana', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Moran-Atkin', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Jenny J', 'Initials': 'JJ', 'LastName': 'Choi', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Diego R', 'Initials': 'DR', 'LastName': 'Camacho', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York. Electronic address: Dicamach@montefiore.org.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.03.031']
660,32403345,Listening to Preferred Music Improved Running Performance without Changing the Pacing Pattern during a 6 Minute Run Test with Young Male Adults.,"Several studies have investigated the effects of music on both submaximal and maximal exercise performance at a constant work-rate. However, there is a lack of research that has examined the effects of music on the pacing strategy during self-paced exercise. The aim of this study was to examine the effects of preferred music on performance and pacing during a 6 min run test (6-MSPRT) in young male adults. Twenty healthy male participants volunteered for this study. They performed two randomly assigned trials (with or without music) of a 6-MSPRT three days apart. Mean running speed, the adopted pacing strategy, total distance covered (TDC), peak and mean heart rate (HRpeak, HRmean), blood lactate (3 min after the test), and rate of perceived exertion (RPE) were measured. Listening to preferred music during the 6-MSPRT resulted in significant TDC improvement (Δ10%;  p =  0.016; effect size (ES) = 0.80). A significantly faster mean running speed was observed when listening to music compared with no music. The improvement of TDC in the present study is explained by a significant overall increase in speed (main effect for conditions) during the music trial. Music failed to modify pacing patterns as suggested by the similar reversed ""J-shaped"" profile during the two conditions. Blood-lactate concentrations were significantly reduced by 9% ( p  = 0.006, ES = 1.09) after the 6-MSPRT with music compared to those in the control condition. No statistically significant differences were found between the test conditions for HRpeak, HRmean, and RPE. Therefore, listening to preferred music can have positive effects on exercise performance during the 6-MSPRT, such as greater TDC, faster running speeds, and reduced blood lactate levels but has no effect on the pacing strategy.",2020,"Blood-lactate concentrations were significantly reduced by 9% ( p  = 0.006, ES = 1.09) after the 6-MSPRT with music compared to those in the control condition.","['Twenty healthy male participants volunteered for this study', 'young male adults', 'Young Male Adults']","['preferred music on performance and pacing during a 6 min run test (6-MSPRT', 'Listening to Preferred Music Improved Running Performance without Changing the Pacing Pattern']","['TDC improvement', 'Blood-lactate concentrations', 'HRpeak, HRmean, and RPE', 'mean running speed', 'blood lactate levels', 'Mean running speed, the adopted pacing strategy, total distance covered (TDC), peak and mean heart rate (HRpeak, HRmean), blood lactate (3 min after the test), and rate of perceived exertion (RPE', 'exercise performance']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",20.0,0.116964,"Blood-lactate concentrations were significantly reduced by 9% ( p  = 0.006, ES = 1.09) after the 6-MSPRT with music compared to those in the control condition.","[{'ForeName': 'Nidhal', 'Initials': 'N', 'LastName': 'Jebabli', 'Affiliation': 'Health and Movement (2SHM) Laboratory, Sport Sciences, High Institute of Sport and Physical Education of Kef, University of Jendouba, le Kef 7001, Tunisia.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Granacher', 'Affiliation': 'Division of Training and Movement Sciences, University of Potsdam, 14469 Potsdam, Germany.'}, {'ForeName': 'Mohamed Amin', 'Initials': 'MA', 'LastName': 'Selmi', 'Affiliation': 'Tunisian Research Laboratory ""Sport Performance Optimization"", National Center of Medicine and Science in Sports (CNMSS), Tunis 1003, Tunisia.'}, {'ForeName': 'Badriya', 'Initials': 'B', 'LastName': 'Al-Haddabi', 'Affiliation': 'Physical Education Department, College of Education, Sultan Qaboos University, Muscat 123, Oman.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Behm', 'Affiliation': ""School of Human Kinetics and Recreation, Memorial University of Newfoundland, St. John's, NL A1C 5S7, Canada.""}, {'ForeName': 'Anis', 'Initials': 'A', 'LastName': 'Chaouachi', 'Affiliation': 'Tunisian Research Laboratory ""Sport Performance Optimization"", National Center of Medicine and Science in Sports (CNMSS), Tunis 1003, Tunisia.'}, {'ForeName': 'Radhouane Haj', 'Initials': 'RH', 'LastName': 'Sassi', 'Affiliation': 'Physical Education Department, College of Education, Sultan Qaboos University, Muscat 123, Oman.'}]","Sports (Basel, Switzerland)",['10.3390/sports8050061']
661,32403367,The Impact of Glucose-Based or Lipid-Based Total Parenteral Nutrition on the Free Fatty Acids Profile in Critically Ill Patients.,"INTRODUCTION


Our study aim was to assess how the macronutrient intake during total parenteral nutrition (TPN) modulates plasma total free fatty acids (FFAs) levels and individual fatty acids in critically ill patients.
METHOD


Adult patients aged 18-80, admitted to the intensive care unit (ICU), who were indicated for TPN, with an expected duration of more than three days, were included in the study. Isoenergetic and isonitrogenous TPN solutions were given with a major non-protein energy source, which was glucose (group G) or glucose and lipid emulsions (Smof lipid; group L). Blood samples were collected on days 0, 1, 3, 6, 9, 14, and 28.
RESULTS


A significant decrease ( p  < 0.001) in total FFAs occurred in both groups with a bigger decrease in group G ( p  < 0.001) from day 0 (0.41 ± 0.19 mmol∙L -1 ) to day 28 (0.10 ± 0.07 mmol∙L -1 ). Increased palmitooleic acid and decreased linoleic and docosahexaenoic acids, with a trend of increased mead acid to arachidonic acid ratio, on day 28 were observed in group G in comparison with group L. Group G had an insignificant increase in leptin with no differences in the concentrations of vitamin E, triacylglycerides, and plasminogen activator inhibitor-1.
CONCLUSION


Decreased plasma FFA in critically ill patients who receive TPN may result from increased insulin sensitivity with a better effect in group G, owing to higher insulin and glucose dosing and no lipid emulsions. It is advisable to include a lipid emulsion at the latest from three weeks of TPN to prevent essential fatty acid deficiency.",2020,A significant decrease ( p  < 0.001) in total FFAs occurred in both groups with a bigger decrease in group G ( p  < 0.001) from day 0 (0.41 ± 0.19 mmol∙L -1 ) to day 28 (0.10 ± 0.07 mmol∙L -1 ).,"['Critically Ill Patients', 'critically ill patients', 'critically ill patients who receive', 'Adult patients aged 18-80, admitted to the intensive care unit (ICU), who were indicated for TPN, with an expected duration of more than three days, were included in the study']","['Isoenergetic and isonitrogenous TPN solutions', 'Glucose-Based or Lipid-Based Total Parenteral Nutrition', 'TPN', 'glucose and lipid emulsions (Smof lipid', 'total parenteral nutrition (TPN']","['plasma total free fatty acids (FFAs) levels and individual fatty acids', 'mead acid to arachidonic acid ratio', 'leptin', 'plasma FFA', 'total FFAs', 'Blood samples', 'insulin sensitivity', 'concentrations of vitamin E, triacylglycerides, and plasminogen activator inhibitor-1', 'Increased palmitooleic acid and decreased linoleic and docosahexaenoic acids']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0030548', 'cui_str': 'Total parenteral nutrition'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0030548', 'cui_str': 'Total parenteral nutrition'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0048945', 'cui_str': '5,8,11-eicosatrienoic acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0030190', 'cui_str': 'Plasminogen activator inhibitor-1'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}]",,0.0386029,A significant decrease ( p  < 0.001) in total FFAs occurred in both groups with a bigger decrease in group G ( p  < 0.001) from day 0 (0.41 ± 0.19 mmol∙L -1 ) to day 28 (0.10 ± 0.07 mmol∙L -1 ).,"[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Skorepa', 'Affiliation': 'Department of Military Internal Medicine and Military Hygiene, Faculty of Military Health Sciences, University of Defence in Brno, Trebesska 1575, 50001 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Ondrej', 'Initials': 'O', 'LastName': 'Sobotka', 'Affiliation': '3rd Department of Internal Medicine-Metabolic Care and Gerontology, University Hospital and Faculty of Medicine in Hradec Kralove, Charles University in Prague, Sokolska 581, 50005 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Vanek', 'Affiliation': 'Department of Military Internal Medicine and Military Hygiene, Faculty of Military Health Sciences, University of Defence in Brno, Trebesska 1575, 50001 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Alena', 'Initials': 'A', 'LastName': 'Ticha', 'Affiliation': 'Department of Clinical Biochemistry and Diagnostics, University Hospital and Faculty of Medicine in Hradec Kralove, Charles University in Prague, Sokolska 581, 50005 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Joao', 'Initials': 'J', 'LastName': 'Fortunato', 'Affiliation': '3rd Department of Internal Medicine-Metabolic Care and Gerontology, University Hospital and Faculty of Medicine in Hradec Kralove, Charles University in Prague, Sokolska 581, 50005 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Manak', 'Affiliation': '3rd Department of Internal Medicine-Metabolic Care and Gerontology, University Hospital and Faculty of Medicine in Hradec Kralove, Charles University in Prague, Sokolska 581, 50005 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Blaha', 'Affiliation': '3rd Department of Internal Medicine-Metabolic Care and Gerontology, University Hospital and Faculty of Medicine in Hradec Kralove, Charles University in Prague, Sokolska 581, 50005 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'Horacek', 'Affiliation': 'Department of Military Internal Medicine and Military Hygiene, Faculty of Military Health Sciences, University of Defence in Brno, Trebesska 1575, 50001 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Lubos', 'Initials': 'L', 'LastName': 'Sobotka', 'Affiliation': '3rd Department of Internal Medicine-Metabolic Care and Gerontology, University Hospital and Faculty of Medicine in Hradec Kralove, Charles University in Prague, Sokolska 581, 50005 Hradec Kralove, Czech Republic.'}]",Nutrients,['10.3390/nu12051373']
662,32403902,"Effects of Oral Procaterol for Postinfectious Cough in Adults: Single-Centre, Randomized Double-Blind, Placebo-Controlled Trial.","Background


Persistent cough following an upper respiratory tract infection (URTI) is common in clinical practice. We investigated the effects of procaterol on cough-specific quality of life (QoL) and peripheral-airway function among adults suffering from postinfectious cough (PIC).
Methods


This was a prospective, randomized, double-blinded placebo-controlled trial (NCT02349919) conducted at a university hospital. Seventy-four non-asthmatic adults who had persistent post-URTI cough for ≥3 weeks were assessed by a physical examination, chest/paranasal sinus radiographs, spirometry, and impulse oscillometry (IOS) and were allocated to receive procaterol or placebo for 4 weeks. The Thai version of the Leicester Cough Questionnaire (LCQ-T), spirometry and IOS were assessed at baseline, 2 weeks, and 4 weeks.
Results


Mean LCQ-T total scores for the procaterol group (10.8) and placebo group (10.9) at baseline were not significantly different (P=0.821). After adjustment for baseline Borg Cough Scale score and post-nasal drip, the mean between-group difference was not significant for LCQ-T total score (-1.26; 95% confidence interval [CI], -2.69 to 0.17), physical domain score (-0.35; 95% CI, -0.76 to 0.06), psychological domain score (-0.53; 95% CI, -1.06 to 0.01), or social domain score (-0.38; 95% CI, -0.92 to 0.16). Large improvements in LCQ-T total score were reported in both groups after 2 weeks (procaterol, 4.21±2.73; placebo, 5.34±3.2), and 4 weeks (procaterol, 5.94±3.68; placebo, 7.07±3.44). No differences between groups were found in the mean changes of spirometry or IOS parameters after 4 weeks.
Conclusion


Our study shows that procaterol is not effective in the treatment of PIC, in terms of improvement of cough-specific QoL or peripheral-airway function.",2020,"Large improvements in LCQ-T total score were reported in both groups after 2 weeks (procaterol, 4.21±2.73; placebo, 5.34±3.2), and 4 weeks (procaterol, 5.94±3.68; placebo, 7.07±3.44).","['Seventy-four non-asthmatic adults who had persistent post-URTI cough for ≥3 weeks were assessed by a physical examination, chest/paranasal sinus radiographs, spirometry, and impulse oscillometry (IOS', 'adults suffering from postinfectious cough (PIC', 'Postinfectious Cough in Adults']","['placebo', 'Placebo', 'procaterol or placebo', 'Oral Procaterol']","['social domain score', 'Cough Scale score', 'cough-specific quality of life (QoL) and peripheral-airway function', 'Leicester Cough Questionnaire (LCQ-T), spirometry and IOS', 'psychological domain score', 'physical domain score', 'mean changes of spirometry or IOS parameters', 'LCQ-T total score', 'cough-specific QoL or peripheral-airway function', 'Mean LCQ-T total scores']","[{'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0030471', 'cui_str': 'Nasal sinus structure'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0029375', 'cui_str': 'Oscillometry'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0072032', 'cui_str': 'Procaterol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0029375', 'cui_str': 'Oscillometry'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.743857,"Large improvements in LCQ-T total score were reported in both groups after 2 weeks (procaterol, 4.21±2.73; placebo, 5.34±3.2), and 4 weeks (procaterol, 5.94±3.68; placebo, 7.07±3.44).","[{'ForeName': 'Prapaporn', 'Initials': 'P', 'LastName': 'Pornsuriyasak', 'Affiliation': 'Division of Pulmonary and Critical Care, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sasivimol', 'Initials': 'S', 'LastName': 'Rattanasiri', 'Affiliation': 'Section for Clinical Epidemiology and Biostatistics, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Nattawut', 'Initials': 'N', 'LastName': 'Unwanatham', 'Affiliation': 'Section for Clinical Epidemiology and Biostatistics, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Theerasuk', 'Initials': 'T', 'LastName': 'Kawamatawong', 'Affiliation': 'Division of Pulmonary and Critical Care, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pennapa', 'Initials': 'P', 'LastName': 'Jankum', 'Affiliation': 'Division of Pulmonary and Critical Care, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Ammarin', 'Initials': 'A', 'LastName': 'Thakkinstian', 'Affiliation': 'Section for Clinical Epidemiology and Biostatistics, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]",Korean journal of family medicine,['10.4082/kjfm.19.0118']
663,32403938,Effectiveness of embedding a specialist preventive care clinician in a community mental health service in increasing preventive care provision: A randomised controlled trial.,"OBJECTIVE


Clinical practice guidelines recommend that community mental health services provide preventive care for clients' chronic disease risk behaviours; however, such care is often not routinely provided. This study aimed to assess the effectiveness of offering clients an additional consultation with a specialist clinician embedded within a community mental health service, in increasing client-reported receipt of, and satisfaction with, preventive care.
METHOD


A randomised controlled trial was undertaken in one Australian community mental health service. Participants ( N  = 811) were randomised to receive usual care (preventive care in routine consultations;  n  = 405) or usual care plus the offer of an additional consultation with a specialist preventive care clinician ( n  = 406). Blinded interviewers assessed at baseline and 1-month follow-up the client-reported receipt of preventive care (assessment, advice and referral) for four key risk behaviours individually (smoking, poor nutrition, alcohol overconsumption and physical inactivity) and all applicable risks combined, acceptance of referrals and satisfaction with preventive care received.
RESULTS


Analyses indicated significantly greater increases in 12 of the 18 preventive care delivery outcomes in the intervention compared to the usual care condition from baseline to follow-up, including assessment for all risks combined (risk ratio = 4.00; 95% confidence interval = [1.57, 10.22]), advice for all applicable risks combined (risk ratio = 2.40; 95% confidence interval = [1.89, 6.47]) and offer of referral to applicable telephone services combined (risk ratio = 20.13; 95% confidence interval = [2.56, 158.04]). For each component of care, there was a significant intervention effect for at least one of the individual risk behaviours. Participants reported high levels of satisfaction with preventive care received, ranging from 77% (assessment) to 87% (referral), with no significant differences between conditions.
CONCLUSION


The intervention had a significant effect on the provision of the majority of recommended elements of preventive care. Further research is needed to maximise its impact, including identifying strategies to increase client uptake.",2020,"RESULTS


Analyses indicated significantly greater increases in 12 of the 18 preventive care delivery outcomes in the intervention compared to the usual care condition from baseline to follow-up, including assessment for all risks combined (risk ratio = 4.00; 95% confidence interval = [1.57, 10.22]), advice for all applicable risks combined (risk ratio = 2.40; 95% confidence interval = [1.89, 6.47]) and offer of referral to applicable telephone services combined (risk ratio = 20.13; 95% confidence interval = [2.56, 158.04]).","['one Australian community mental health service', 'Participants ( N \u2009=\u2009811', ""clients' chronic disease risk behaviours""]","['embedding a specialist preventive care clinician', 'preventive care (assessment, advice and referral) for four key risk behaviours individually (smoking, poor nutrition, alcohol overconsumption and physical inactivity', 'usual care (preventive care in routine consultations;  n \u2009=\u2009405) or usual care plus the offer of an additional consultation with a specialist preventive care clinician']","['18 preventive care delivery outcomes', 'provision of the majority of recommended elements of preventive care']","[{'cui': 'C0009475', 'cui_str': 'Mental Health Services, Community'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C4277527', 'cui_str': 'Preventative Care'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C3890554', 'cui_str': 'Physical Inactivity'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C4517768', 'cui_str': '405'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C2090905', 'cui_str': 'Specialist consultation'}]","[{'cui': 'C4277527', 'cui_str': 'Preventative Care'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}]",811.0,0.0905598,"RESULTS


Analyses indicated significantly greater increases in 12 of the 18 preventive care delivery outcomes in the intervention compared to the usual care condition from baseline to follow-up, including assessment for all risks combined (risk ratio = 4.00; 95% confidence interval = [1.57, 10.22]), advice for all applicable risks combined (risk ratio = 2.40; 95% confidence interval = [1.89, 6.47]) and offer of referral to applicable telephone services combined (risk ratio = 20.13; 95% confidence interval = [2.56, 158.04]).","[{'ForeName': 'Caitlin Mc', 'Initials': 'CM', 'LastName': 'Fehily', 'Affiliation': 'School of Psychology, Faculty of Science and Information Technology, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Kate M', 'Initials': 'KM', 'LastName': 'Bartlem', 'Affiliation': 'School of Psychology, Faculty of Science and Information Technology, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Wiggers', 'Affiliation': 'The Australian Prevention Partnership Centre (TAPPC), Sax Institute, Ultimo, NSW, Australia.'}, {'ForeName': 'Paula M', 'Initials': 'PM', 'LastName': 'Wye', 'Affiliation': 'School of Psychology, Faculty of Science and Information Technology, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Richard V', 'Initials': 'RV', 'LastName': 'Clancy', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Castle', 'Affiliation': 'Department of Psychiatry, The University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'The Australian Prevention Partnership Centre (TAPPC), Sax Institute, Ultimo, NSW, Australia.'}, {'ForeName': 'Chris E', 'Initials': 'CE', 'LastName': 'Rissel', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Wutzke', 'Affiliation': 'The Australian Prevention Partnership Centre (TAPPC), Sax Institute, Ultimo, NSW, Australia.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Hodder', 'Affiliation': 'School of Psychology, Faculty of Science and Information Technology, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Colyvas', 'Affiliation': 'School of Mathematical and Physical Sciences, Faculty of Science and Information Technology, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Fionna', 'Initials': 'F', 'LastName': 'Murphy', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'Jenny A', 'Initials': 'JA', 'LastName': 'Bowman', 'Affiliation': 'School of Psychology, Faculty of Science and Information Technology, The University of Newcastle, Callaghan, NSW, Australia.'}]",The Australian and New Zealand journal of psychiatry,['10.1177/0004867420914741']
664,32404181,Reducing sitting at work: process evaluation of the SMArT Work (Stand More At Work) intervention.,"BACKGROUND


Office-based workers accumulate high amounts of sitting time. Stand More At Work (SMArT Work) aimed to reduce occupational sitting time and a cluster randomised controlled trial demonstrated it was successful in achieving this aim. The purpose of this paper is to present the process evaluation of the SMArT Work intervention.
METHODS


Questionnaire data were collected from intervention participants at 6 months (n = 58) and 12 months (n = 55). Questionnaires sought feedback on the different components of the intervention (education, height-adjustable desk, Darma cushion, behaviour feedback, progress chats (coaching) with research team, action planning/goal setting diary) and experiences of evaluation measures. Control participants (n = 37) were asked via questionnaire at 12-month follow-up about the impact of the study on their behaviour and any lifestyle changes made during the study. Participants from both arms were invited to focus groups to gain a deeper understanding of their experiences on completion of 12-month follow-up.
RESULTS


Focus group and questionnaire data showed a positive attitude towards the height-adjustable workstation with a high proportion of participants using it every day (62%). Most participants (92%) felt the education seminar increased their awareness of the health consequences of too much sitting and motivated them to change their behaviour. Receiving feedback on their sitting time and support from the research team also encouraged behaviour change. The Darma cushion and action planning/goal setting diary were seen to be less helpful for behaviour change. Benefits experienced included fewer aches and pains, improved cognitive functioning, increased productivity, more energy and positive feelings about general health.
CONCLUSIONS


Key elements of the programme identified as facilitating behaviour change were the educational seminar, the height-adjustable workstation, behavioural feedback and regular contact with research staff through regular progress chats.
TRIAL REGISTRATION


ISRCTN: ISRCTN10967042. Registered on 2 February 2015.",2020,"Benefits experienced included fewer aches and pains, improved cognitive functioning, increased productivity, more energy and positive feelings about general health.
","['Control participants (n\u2009=\u200937', 'Questionnaire data were collected from intervention participants at 6 months (n\u2009=\u200958) and 12\u2009months (n\u2009=\u200955']",[],"['aches and pains, improved cognitive functioning, increased productivity, more energy and positive feelings about general health']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],"[{'cui': 'C0001044', 'cui_str': 'Acetylcholinesterase'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}]",,0.0323989,"Benefits experienced included fewer aches and pains, improved cognitive functioning, increased productivity, more energy and positive feelings about general health.
","[{'ForeName': 'Stuart J H', 'Initials': 'SJH', 'LastName': 'Biddle', 'Affiliation': 'Centre for Health Research, University of Southern Queensland, Springfield,, QLD, 4300, Australia.'}, {'ForeName': 'Sophie E', 'Initials': 'SE', 'LastName': ""O'Connell"", 'Affiliation': 'Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dunstan', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Edwardson', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. ce95@le.ac.uk.'}, {'ForeName': 'Dale W', 'Initials': 'DW', 'LastName': 'Esliger', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Gray', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yates', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK.'}, {'ForeName': 'Fehmidah', 'Initials': 'F', 'LastName': 'Munir', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}]",Trials,['10.1186/s13063-020-04300-7']
665,32404226,"Efficacy of internet-delivered acceptance and commitment therapy for severe health anxiety: results from a randomized, controlled trial.","BACKGROUND


Health anxiety is common, disabling and costly due to patients' extensive use of health care services. Internet-delivered treatment may overcome barriers of accessibility to specialized treatment. We aimed to evaluate the efficacy of internet-delivered acceptance and commitment therapy (iACT).
METHODS


A randomized, controlled trial of iACT versus an internet-delivered discussion forum (iFORUM), performed in a Danish university hospital setting. Patients self-referred and underwent video-diagnostic assessment. Eligible patients (≥18 years) with health anxiety were randomized to 12 weeks of intervention. The randomization was blinded for the assessor. The primary outcome was between-group unadjusted mean differences in health anxiety symptoms measured by the Whiteley-7 Index (WI-7, range 0-100) from baseline to 6-month follow-up (6-MFU) using intention to treat and a linear mixed model. The study is registered at clinicaltrials.gov, number NCT02735434.
RESULTS


A total of 151 patients self-referred, and 101 patients were randomized to iACT (n = 53) or iFORUM (n = 48). A mean difference in change over time of 19.0 points [95% confidence interval (CI) 10.8-27.2, p < 0.001] was shown on the WI-7, and a large standardized effect size of d = 0.80 (95% CI 0.38-1.23) at 6-MFU. The number needed to treat was 2.8 (95% CI 1.8-6.1, p < 0.001), and twice as many patients in iACT were no longer clinical cases (35% v. 16%; risk ratio 2.17, 95% CI 1.00-4.70, p = 0.050). Adverse events were few and insignificant.
CONCLUSIONS


iACT for health anxiety led to sustained effects at 6-MFU. The study contributes to the development of easily accessible treatment options and deserves wider application.",2020,"The number needed to treat was 2.8 (95% CI 1.8-6.1, p < 0.001), and twice as many patients in iACT were no longer clinical cases (35% v. 16%; risk ratio 2.17, 95% CI 1.00-4.70, p = 0.050).","['severe health anxiety', '151 patients self-referred, and 101 patients', 'Danish university hospital setting', 'Eligible patients (≥18 years) with health anxiety']","['internet-delivered acceptance and commitment therapy (iACT', 'internet-delivered discussion forum (iFORUM', 'internet-delivered acceptance and commitment therapy', 'iACT']","['number needed to treat', 'Adverse events', 'health anxiety symptoms']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3266254', 'cui_str': 'Referred by self'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}]","[{'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",151.0,0.303182,"The number needed to treat was 2.8 (95% CI 1.8-6.1, p < 0.001), and twice as many patients in iACT were no longer clinical cases (35% v. 16%; risk ratio 2.17, 95% CI 1.00-4.70, p = 0.050).","[{'ForeName': 'Ditte', 'Initials': 'D', 'LastName': 'Hoffmann', 'Affiliation': 'The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Noerrebrogade 44, bldg. 2C, 1, 8000Aarhus C, Denmark.'}, {'ForeName': 'Charlotte Ulrikka', 'Initials': 'CU', 'LastName': 'Rask', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Palle Juul-Jensens Boulevard 175, ent. K, 8200Aarhus, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hedman-Lagerlöf', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute, Tomtebodavägen 18A, 5, 171 77Stockholm, Sweden.'}, {'ForeName': 'Jens Søndergaard', 'Initials': 'JS', 'LastName': 'Jensen', 'Affiliation': 'The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Noerrebrogade 44, bldg. 2C, 1, 8000Aarhus C, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Frostholm', 'Affiliation': 'The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Noerrebrogade 44, bldg. 2C, 1, 8000Aarhus C, Denmark.'}]",Psychological medicine,['10.1017/S0033291720001312']
666,32404279,Stimulation of the vagus nerve reduces learning in a go/no-go reinforcement learning task.,"When facing decisions to approach rewards or to avoid punishments, we often figuratively go with our gut, and the impact of metabolic states such as hunger on motivation are well documented. However, whether and how vagal feedback signals from the gut influence instrumental actions is unknown. Here, we investigated the effect of non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) vs. sham (randomized cross-over design) on approach and avoidance behavior using an established go/no-go reinforcement learning paradigm in 39 healthy human participants (23 female) after an overnight fast. First, mixed-effects logistic regression analysis of choice accuracy showed that taVNS acutely impaired decision-making, p = .041. Computational reinforcement learning models identified the cause of this as a reduction in the learning rate through taVNS (∆α = -0.092, p boot  = .002), particularly after punishment (∆α Pun  = -0.081, p boot  = .012 vs. ∆α Rew  =-0.031, p boot  = .22). However, taVNS had no effect on go biases, Pavlovian response biases or response time. Hence, taVNS appeared to influence learning rather than action execution. These results highlight a novel role of vagal afferent input in modulating reinforcement learning by tuning the learning rate according to homeostatic needs.",2020,"First, mixed-effects logistic regression analysis of choice accuracy showed that taVNS acutely impaired decision-making, p = .041.",['39 healthy human participants (23 female) after an overnight fast'],['non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) vs. sham (randomized cross-over design'],"['go biases, Pavlovian response biases or response time']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}]","[{'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",39.0,0.0349857,"First, mixed-effects logistic regression analysis of choice accuracy showed that taVNS acutely impaired decision-making, p = .041.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kühnel', 'Affiliation': 'Department of Translational Research in Psychiatry, Max Planck Institute of Psychiatry and International Max Planck Research School for Translational Psychiatry (IMPRS-TP), Munich, Germany. Electronic address: anne_kuehnel@psych.mpg.de.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Teckentrup', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstr. 14, 72076 Tübingen, Germany.'}, {'ForeName': 'Monja P', 'Initials': 'MP', 'LastName': 'Neuser', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstr. 14, 72076 Tübingen, Germany.'}, {'ForeName': 'Quentin J M', 'Initials': 'QJM', 'LastName': 'Huys', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom; Max Planck UCL Centre for Computational Psychiatry and Ageing Research, London, United Kingdom.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Burrasch', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstr. 14, 72076 Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Walter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstr. 14, 72076 Tübingen, Germany; Otto-von-Guericke University Magdeburg, Department of Psychiatry and Psychotherapy, Magdeburg, Germany; Department of Psychiatry and Psychotherapy, Jena University Hospital, Jena, Germany; Leibniz Institute for Neurobiology, Magdeburg, Germany.'}, {'ForeName': 'Nils B', 'Initials': 'NB', 'LastName': 'Kroemer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstr. 14, 72076 Tübingen, Germany. Electronic address: nils.kroemer@uni-tuebingen.de.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2020.03.023']
667,32404287,Cardiopulmonary exercise testing and aerobic treadmill training after stroke: Feasibility of a controlled trial.,"PURPOSE


To investigate the feasibility and safety of a randomized controlled trial that performed cardiopulmonary exercise testing and 12 weeks of aerobic treadmill training in individuals in the chronic phase after stroke.
METHODS


The following data were recorded: number of individuals contacted to participate, that attended in the evaluation session, and that were included (recruited) in the study; retention, attendance and adherence rates; reasons for exclusion, withdrawal, non-attendance and non-completing exercise; adverse events.
RESULTS


From 230 individuals that were contacted, 39 (17%) attended the evaluation session and 22 (9.6%) were recruited in the study, 11 in each group (control and experimental). The main source of recruitment was other research projects (43.5%). The main reason for exclusion was unavailability (22%). Six out of 39 individuals (15.4%) that attended in the evaluation session were not able to perform the cardiopulmonary exercise testing. All subjects included showed a respiratory exchange ratio ≥1.0 (considered as maximal effort in the CPET). Retention rate was 81% and the main reason of withdrawal was unavailability (75%). The overall attendance rate was 88% and the main reason for non-attendance was illness/sickness (20.8%). The adherence rate was 99% and the reasons for non-completing sessions were illness/sickness (60%) or delay (40%). No serious adverse events occurred.
CONCLUSION


Recruitment rate was low, retention rate was moderate, attendance and adherence rates were high. No serious adverse events occurred. It was feasible and safe to execute a randomized clinical trial that performed cardiopulmonary exercise testing and 12 weeks of aerobic treadmill training.",2020,"No serious adverse events occurred.
","['From 230 individuals that were contacted, 39 (17%) attended the evaluation session and 22 (9.6%) were recruited in the study, 11 in each group (control and experimental', 'individuals contacted to participate, that attended in the evaluation session, and that were included (recruited) in the study; retention, attendance and adherence rates; reasons for exclusion, withdrawal, non-attendance and non-completing exercise; adverse events', 'individuals in the chronic phase after stroke']","['cardiopulmonary exercise testing and 12 weeks of aerobic treadmill training', 'Cardiopulmonary exercise testing and aerobic treadmill training']","['adherence rate', 'overall attendance rate', 'retention rate was moderate, attendance and adherence rates', 'Retention rate']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",,0.106437,"No serious adverse events occurred.
","[{'ForeName': 'Sherindan Ayessa Ferreira De', 'Initials': 'SAF', 'LastName': 'Brito', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Av. Antônio Carlos, 6627, Campus Pampulha, CEP: 31270-910, Belo Horizonte, Brazil. Electronic address: sherindanayessa@hotmail.com.'}, {'ForeName': 'Larissa Tavares', 'Initials': 'LT', 'LastName': 'Aguiar', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Av. Antônio Carlos, 6627, Campus Pampulha, CEP: 31270-910, Belo Horizonte, Brazil. Electronic address: larissatavaresaguiar@gmail.com.'}, {'ForeName': 'Laura Nolasco', 'Initials': 'LN', 'LastName': 'Garcia', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Av. Antônio Carlos, 6627, Campus Pampulha, CEP: 31270-910, Belo Horizonte, Brazil. Electronic address: lauranolasco15@hotmail.com.'}, {'ForeName': 'Paula Da Cruz', 'Initials': 'PDC', 'LastName': 'Peniche', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Av. Antônio Carlos, 6627, Campus Pampulha, CEP: 31270-910, Belo Horizonte, Brazil. Electronic address: penichepaula@yahoo.com.br.'}, {'ForeName': 'Maria Teresa Ferreira Dos', 'Initials': 'MTFD', 'LastName': 'Reis', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Av. Antônio Carlos, 6627, Campus Pampulha, CEP: 31270-910, Belo Horizonte, Brazil. Electronic address: mariateresafdr@gmail.com.'}, {'ForeName': 'Christina Danielli Coelho De Morais', 'Initials': 'CDCM', 'LastName': 'Faria', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Av. Antônio Carlos, 6627, Campus Pampulha, CEP: 31270-910, Belo Horizonte, Brazil. Electronic address: cdcmf@ufmg.br.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.104854']
668,32404342,"Canakinumab for Treatment of Adult-Onset Still's Disease to Achieve Reduction of Arthritic Manifestation (CONSIDER): phase II, randomised, double-blind, placebo-controlled, multicentre, investigator-initiated trial.","BACKGROUND


Inhibition of interleukin (IL)-1 represents a promising treatment option in adult-onset Still's disease (AOSD).
OBJECTIVE


To investigate the efficacy and safety of canakinumab in patients with AOSD and active joint involvement by means of a multicentre, double-blind, randomised, placebo-controlled trial.
METHODS


Patients with AOSD and active joint involvement (tender and swollen joint counts of ≥4 each) were treated with canakinumab (4 mg/kg, maximum 300 mg subcutaneous every 4 weeks) or placebo. The primary endpoint was the proportion of patients with a clinically relevant reduction in disease activity at week 12 as determined by the change in disease activity score (ΔDAS28>1.2).
RESULTS


At enrolment, patients had high active disease with a mean DAS28(ESR) of 5.4 in the canakinumab and 5.3 in the placebo group, respectively. In the intention-to-treat analysis, 12 patients (67%) in the canakinumab group and 7 patients (41%) in the placebo group fulfilled the primary outcome criterion (p=0.18). In the per-protocol analysis, significantly higher American College of Rheumatology (ACR) 30% (61% vs 20%, p=0.033), ACR 50% (50% vs 6.7%, p=0.009) and ACR 70% (28% vs 0%, p=0.049) response rates were observed in the canakinumab group compared with the placebo group. Two patients in the canakinumab group experienced a serious adverse event.
CONCLUSION


Although the study was terminated prematurely and the primary endpoint was not achieved, treatment with canakinumab led to an improvement of several outcome measures in AOSD. The overall safety findings were consistent with the known profile of canakinumab. Thus, our data support indication for IL-1 inhibition with canakinumab in AOSD.",2020,"Two patients in the canakinumab group experienced a serious adverse event.
","[""adult-onset Still's disease (AOSD"", 'patients had high active disease with a mean DAS28(ESR) of 5.4 in the canakinumab and 5.3 in the', 'patients with AOSD and active joint involvement by means of a multicentre', 'Adult-Onset', 'Patients with AOSD and active joint involvement (tender and swollen joint counts of ≥4\u2009each']","['canakinumab', 'interleukin (IL)-1', 'Canakinumab', 'canakinumab (4\u2009mg/kg, maximum 300\u2009mg subcutaneous every 4 weeks) or placebo', 'placebo']","['several outcome measures in AOSD', 'response rates', 'American College of Rheumatology (ACR', 'disease activity score (ΔDAS28>1.2', 'serious adverse event', 'proportion of patients with a clinically relevant reduction in disease activity', 'efficacy and safety']","[{'cui': 'C0085253', 'cui_str': ""Adult onset Still's disease""}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0234234', 'cui_str': 'Tender'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count'}]","[{'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0085253', 'cui_str': ""Adult onset Still's disease""}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.675758,"Two patients in the canakinumab group experienced a serious adverse event.
","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Kedor', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany claudia.kedor@charite.de.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Listing', 'Affiliation': 'Epidemiology Unit, German Rheumatism Research Centre, Berlin, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Zernicke', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Weiß', 'Affiliation': 'Epidemiology Unit, German Rheumatism Research Centre, Berlin, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Behrens', 'Affiliation': 'CIRI/Rheumatology and Fraunhofer TMP, Goethe-University, Frankfurt, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Blank', 'Affiliation': 'Internal Medicine 5, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Joerg Christoph', 'Initials': 'JC', 'LastName': 'Henes', 'Affiliation': 'Centre for Interdisciplinary Clinical Immunology, Rheumatology and Auto-inflammatory Diseases and Department of Internal Medicine II (Oncology, Haematology, Immunology, Rheumatology, Pulmology), University Hospital Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Joern', 'Initials': 'J', 'LastName': 'Kekow', 'Affiliation': 'Clinic of Rheumatology and Orthopaedics, Otto-von-Guericke University Magdeburg, Vogelsang-Gommern, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rubbert-Roth', 'Affiliation': 'Division of Rheumatology, Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Schulze-Koops', 'Affiliation': 'Department of Rheumatology, University of Munich, Munich, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Seipelt', 'Affiliation': 'Abteilung Rheumatologie und Klinische Immunologie, Immanuel Krankenhaus Berlin, Standort Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Specker', 'Affiliation': 'Klinik für Rheumatologie und Klinische Immunologie, KEM Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Feist', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217155']
669,32199656,[Effectiveness of magnesium sulfate compared to rocuronium for rapid sequence tracheal intubation in adults: clinical randomized trial].,"INTRODUCTION AND OBJECTIVES


Magnesium sulfate has been used in anesthesia because it has relevant clinical features such as: analgesia, autonomic response control and muscle relaxation. Using the agent to establish adequate conditions for tracheal intubation remains controversial. The aim of the study was to compare the effectiveness of magnesium sulfate and rocuronium for rapid sequence tracheal intubation in adults.
METHODS


Double blind, randomized, unicentric, prospective study assessed 68 patients, ASA 1 or 2, over 18 years, scheduled for appendectomy under general anesthesia. Patients were divided into two groups. GM patients received 50 mg.kg -1 magnesium sulfate and GR patients, 1 mg.kg -1  rocuronium immediately before anesthesia induction. Arterial Blood Pressure (BP) and Heart Rate (HR) were measured in both groups at five times related to the administration of the drugs studied. The primary variable was the clinical status of tracheal intubation.
TRIAL REGISTRY


RBR-4xr92k.
RESULTS


GM was associated with no significant hemodynamic parameter change after injection. GM showed 85% (29/34) poor intubation clinical status, 15% (5/34) good, and 0% excellent (< 0.0001).
CONCLUSION


Magnesium sulfate did not provide adequate clinical status when compared to rocuronium at a dose of 50 mg.kg -1  for rapid sequence intubation in adult patients.",2020,"GM showed 85% (29/34) poor intubation clinical status, 15% (5/34) good, and 0% excellent (< 0.0001).
","['adult patients', 'rapid sequence tracheal intubation in adults', '68\xa0patients, ASA\xa01\xa0or\xa02, over\xa018\xa0years, scheduled for appendectomy under general anesthesia']","['rocuronium', 'Magnesium sulfate', 'magnesium sulfate', '50\xa0mg.kg -1 magnesium sulfate and GR patients, 1\xa0mg.kg -1  rocuronium', 'magnesium sulfate and rocuronium']","['intubation clinical status', 'Arterial Blood Pressure (BP) and Heart Rate (HR', 'clinical status of tracheal intubation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0449440', 'cui_str': 'Clinical status (attribute)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}]",,0.336571,"GM showed 85% (29/34) poor intubation clinical status, 15% (5/34) good, and 0% excellent (< 0.0001).
","[{'ForeName': 'Fabiano Timbó', 'Initials': 'FT', 'LastName': 'Barbosa', 'Affiliation': 'Universidade Federal de Alagoas, Maceió, AL, Brasil. Electronic address: fabiano.barbosa@famed.ufal.br.'}, {'ForeName': 'Olavo Barbosa de Oliveira', 'Initials': 'OBO', 'LastName': 'Neto', 'Affiliation': 'Universidade Federal de Alagoas, Maceió, AL, Brasil.'}, {'ForeName': 'Luciano Timbó', 'Initials': 'LT', 'LastName': 'Barbosa', 'Affiliation': 'Hospital Geral do Estado Professor Osvaldo Brandão Vilela, Maceió, AL, Brasil.'}, {'ForeName': 'Raul Ribeiro de', 'Initials': 'RR', 'LastName': 'Andrade', 'Affiliation': 'Centro Universitário CESMAC, Maceió, AL, Brasil.'}, {'ForeName': 'Êurica Adélia Nogueira', 'Initials': 'ÊAN', 'LastName': 'Ribeiro', 'Affiliation': 'Universidade Federal de Alagoas, Maceió, AL, Brasil.'}, {'ForeName': 'Célio Fernando de Sousa', 'Initials': 'CFS', 'LastName': 'Rodrigues', 'Affiliation': 'Universidade Federal de Alagoas, Maceió, AL, Brasil.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2019.12.002']
670,32200512,Efficacy and Safety of Ixekizumab Through 5 Years in Moderate-to-Severe Psoriasis: Long-Term Results from the UNCOVER-1 and UNCOVER-2 Phase-3 Randomized Controlled Trials.,"INTRODUCTION


Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A, is approved for treatment of moderate-to-severe plaque psoriasis. Our objective was to evaluate the long-term efficacy and safety of ixekizumab in moderate-to-severe plaque psoriasis through 5 years.
METHODS


Data were integrated from the UNCOVER-1 and UNCOVER-2, randomized, double-blinded, phase-3 trials. Patients who continuously received the labeled ixekizumab dose, were static Physician's Global Assessment (sPGA) (0,1) responders at Week 12 and completed 60 weeks of treatment could enter the long-term extension (LTE) period. Patients could escalate to every-2-week dosing per investigator opinion. Efficacy and health outcomes included proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75/90/100, sPGA (0,1) and (0), absolute PASI ≤ 5/ ≤ 3/ ≤ 2/ ≤ 1 and Dermatology Life Quality Index (DLQI) (0,1). Results exclude patients who escalated to every-2-week dosing. A modified non-responder imputation method was used to account for missing data. Supplemental analyses include patients who escalated to every-2-week dosing and observed and multiple imputation results. Exposure-adjusted safety outcomes are also reported.
RESULTS


Of 206 patients who entered the LTE periods, 172 completed treatment. At Week 60, PASI 75/90/100 responses were 94.7%, 85.0% and 62.1%, respectively, and at year 5 were 90.3%, 71.3% and 46.3%, respectively. Similarly, meaningful responses were achieved for the other efficacy and health measures. Among patients with PASI 100 through 5 years, 92% achieved DLQI (0,1), indicating no impact of skin disease on quality of life. During the LTE period, exposure-adjusted incidence rates were 31.4 per 100 patient-years for treatment-emergent adverse events and 6.8 per 100 patient-years for serious adverse events. No deaths were reported. No new or unexpected safety findings were noted.
CONCLUSIONS


The results demonstrate 80 mg ixekizumab maintains long-term efficacy and a safety profile consistent with previous data in patients with moderate-to-severe plaque psoriasis through 5 years of treatment.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, UNCOVER-1: NCT01474512, UNCOVER-2: NCT01597245.",2020,"No new or unexpected safety findings were noted.
","['206 patients who entered the LTE periods, 172 completed treatment', 'moderate-to-severe plaque psoriasis through 5\xa0years', 'patients with moderate-to-severe plaque psoriasis through 5\xa0years of treatment', 'Through 5 Years in Moderate-to-Severe Psoriasis']","['ixekizumab', 'Ixekizumab', ""labeled ixekizumab dose, were static Physician's Global Assessment (sPGA""]","['exposure-adjusted incidence rates', 'Efficacy and Safety', 'PASI 75/90/100 responses', 'quality of life', 'proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75/90/100, sPGA (0,1) and (0), absolute PASI\u2009≤\u20095', 'Dermatology Life Quality Index (DLQI) (0,1']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034380'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}]",206.0,0.0947104,"No new or unexpected safety findings were noted.
","[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Leonardi', 'Affiliation': 'Central Dermatology, St. Louis, MO, USA.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Foley', 'Affiliation': ""St. Vincent's Hospital Melbourne and Probity Medical Research, Skin Health Institute, The University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Hideshi', 'Initials': 'H', 'LastName': 'Torii', 'Affiliation': 'Division of Dermatology, Tokyo Yamate Medical Center, Tokyo, Japan.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Gerdes', 'Affiliation': 'Psoriasis-Center at the Department of Dermatology, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Lyn', 'Initials': 'L', 'LastName': 'Guenther', 'Affiliation': 'Guenther Dermatology Research Centre, London, ON, Canada.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': 'SkiN Centre for Dermatology and Probity Medical Research, Peterborough, ON, Canada.'}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Ferris', 'Affiliation': 'University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Christopher E M', 'Initials': 'CEM', 'LastName': 'Griffiths', 'Affiliation': 'Dermatology Centre, Salford Royal Hospital, University of Manchester, Manchester, UK.'}, {'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'ElMaraghy', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Crane', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Patel', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Russel', 'Initials': 'R', 'LastName': 'Burge', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shrom', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA. shrom_david_stanley@lilly.com.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Leung', 'Affiliation': 'Syneos Health, Morrisville, NC, USA.'}, {'ForeName': 'Chen-Yen', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'K. Papp Clinical Research and Probity Medical Research Inc., Waterloo, ON, Canada.'}]",Dermatology and therapy,['10.1007/s13555-020-00367-x']
671,32205274,"Effectiveness of acupuncture in dental surgery, a randomized clinical trial crossover study.","Aim: The objective of this crossover clinical study was to evaluate the effectiveness of Energy Regulation with Acupuncture in clinical occurrences in impacted lower third molar surgeries. 
Methods: The sample consisted of 22 patients with two impacted third molars, in symmetrical position; divided into two groups: Test Group (TG) with Real Energy Regulation Group and Sham Group (SG) with Acupuncture without Energy Regulation function. The extraction was performed 30 days apart. Energy flow (Ryodoraku Method) and energy regulation performed before extraction were measured. Heart Rate (HR) and Blood Pressure (BP) were evaluated before and after energy regulation and after surgery, residual edema was measured by facial measurements (angle of the mandible to tragus (A-T); angle of the mandible to labial commissure (A-LC); angle of the mandible to the wing of the nose (A-WN); angle of the mandible to the corner of the eye (A-CE); angle of the mandible to the chin (AC); and mouth opening by the interincisal distance, before and after seven days of surgery. To quantify intraoperative bleeding (ml), blood was aspirated along with the saline solution using a portable vacuum pump adaptor. The amount of saline solution used was subtracted from the final amount of aspirated fluid. 
Results: Mean of bleeding was lower in TG (p=0.0392). There were significant differences between groups in facial distances: A-LC (p=0.010), A-WN (p=0.030) and A-C (p=0.008). 
Conclusion: Energy regulation with real acupuncture was effective in reducing postoperative residual edema and intraoperative bleeding.",2020,"There were significant differences between groups in facial distances: A-LC (p=0.010), A-WN (p=0.030) and A-C (p=0.008).","['dental surgery', 'p></o', 'impacted lower third molar surgeries', '22 patients with two impacted third molars, in symmetrical position; divided into two groups']","['Test Group (TG) with Real Energy Regulation Group and Sham Group (SG) with Acupuncture without Energy Regulation function', 'real acupuncture', 'Acupuncture', 'Methods:</span></a><span lang=""EN-US"" style=""fontfamily', 'span><span', 'Aim</span><span lang=""EN-US"" style=""font-family', 'span><span lang=""IT"" style=""font-family', 'Results:</span><span', 'sans-serif;""><o', 'acupuncture']","['facial distances: A-LC', 'postoperative residual edema and intraoperative bleeding.</span><span', 'Heart Rate (HR) and Blood Pressure (BP', 'Energy flow (Ryodoraku Method) and energy regulation', 'Mean of bleeding']","[{'cui': 'C0204324', 'cui_str': 'Dental surgical procedure'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0442051', 'cui_str': 'Lower third (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0394662', 'cui_str': 'Ryodoraku (regime/therapy)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",22.0,0.0223714,"There were significant differences between groups in facial distances: A-LC (p=0.010), A-WN (p=0.030) and A-C (p=0.008).","[{'ForeName': 'Maria Lúcia Bressiani', 'Initials': 'MLB', 'LastName': 'Gil', 'Affiliation': ""Department of Health Sciences and Children's Dentistry, Piracicaba School of Dentistry. State University of Campinas, São Paulo, Brazil. Electronic address: marialubgil@gmail.com.""}, {'ForeName': 'Luide Michel Rodrigues', 'Initials': 'LMR', 'LastName': 'França Marinho', 'Affiliation': 'Department of Oral and maxillofacial Surgery and Traumatology, Piracicaba School of Dentistry. State University of Campinas, São Paulo, Brazil.'}, {'ForeName': 'Márcio de', 'Initials': 'M', 'LastName': 'Moraes', 'Affiliation': 'Department of Oral and maxillofacial Surgery and Traumatology, Piracicaba School of Dentistry. State University of Campinas, São Paulo, Brazil.'}, {'ForeName': 'Ronaldo', 'Initials': 'R', 'LastName': 'Seichi Wada', 'Affiliation': ""Department of Health Sciences and Children's Dentistry, Piracicaba School of Dentistry. State University of Campinas, São Paulo, Brazil.""}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Carlos Groppo', 'Affiliation': 'Department of Physiological Sciences, Piracicaba School of Dentistry. State University of Campinas, São Paulo, Brazil.'}, {'ForeName': 'Jorge Eiji', 'Initials': 'JE', 'LastName': 'Sato', 'Affiliation': 'Pain Clinic, São Paulo, Brazil.'}, {'ForeName': 'Maria da Luz', 'Initials': 'MDL', 'LastName': 'Rosário de Sousa', 'Affiliation': ""Department of Health Sciences and Children's Dentistry, Piracicaba School of Dentistry. State University of Campinas, São Paulo, Brazil. Electronic address: luzsousa@fop.unicamp.br.""}]",Journal of acupuncture and meridian studies,['10.1016/j.jams.2020.03.063']
672,32202075,Efficacy and Safety of Ertugliflozin in Patients with Overweight and Obesity with Type 2 Diabetes Mellitus.,"OBJECTIVE


This study aimed to evaluate ertugliflozin in patients with overweight and obesity with type 2 diabetes mellitus.
METHODS


Data from three placebo-controlled, randomized, Phase 3 studies were pooled. Patients with baseline BMI ≥ 25 (1,377/1,544; 89%) were assessed with a stratification by BMI subgroup.
RESULTS


At week 26, reductions from baseline in glycated hemoglobin A1c (HbA1c), fasting plasma glucose, body weight (BW), and systolic blood pressure (SBP) were greater with ertugliflozin versus placebo. For placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg, respectively, least squares mean change was 0.1%, -0.8%, and -0.9% for HbA1c and -1.2 kg, -3.1 kg, and -3.2 kg for BW. HbA1c reductions were consistent across BMI subgroups. For ertugliflozin 5 mg and 15 mg, least squares mean change (placebo adjusted) in absolute BW was -1.4 kg and -1.2 kg for BMI 25 to < 30, -1.8 kg and -1.9 kg for BMI 30 to < 35, and -2.5 kg and -2.9 kg for BMI ≥ 35. Percent BW changes were similar across BMI subgroups. Incidence of adverse events was 52.5%, 44.6%, and 50.1% with placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg, respectively.
CONCLUSIONS


Meaningful reductions in HbA1c, fasting plasma glucose, BW, and SBP were observed with ertugliflozin in patients with overweight and obesity with type 2 diabetes mellitus. Ertugliflozin improved HbA1c and SBP and reduced BW across BMI subgroups. Ertugliflozin was generally well tolerated.",2020,"At week 26, reductions from baseline in glycated hemoglobin A1c (HbA1c), fasting plasma glucose, body weight (BW), and systolic blood pressure (SBP) were greater with ertugliflozin versus placebo.","['patients with overweight and obesity with\xa0type 2 diabetes mellitus', 'Patients with Overweight and Obesity with Type 2 Diabetes Mellitus', 'Patients with baseline BMI\u2009≥\u200925 ', 'patients with overweight and obesity with type 2 diabetes mellitus']","['ertugliflozin versus placebo', 'Ertugliflozin', 'ertugliflozin', 'placebo, ertugliflozin', 'placebo, ertugliflozin 5 mg, and ertugliflozin']","['HbA1c reductions', 'Efficacy and Safety', 'tolerated', 'Incidence of adverse events', 'HbA1c, fasting plasma glucose, BW, and SBP', 'HbA1c and SBP and reduced BW', 'glycated hemoglobin A1c (HbA1c), fasting plasma glucose, body weight (BW), and systolic blood pressure (SBP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4535679', 'cui_str': 'ertugliflozin 5 MG'}]","[{'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",,0.0537002,"At week 26, reductions from baseline in glycated hemoglobin A1c (HbA1c), fasting plasma glucose, body weight (BW), and systolic blood pressure (SBP) were greater with ertugliflozin versus placebo.","[{'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Heymsfield', 'Affiliation': 'Pennington Biomedical Research Center, LSU System, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Annaswamy', 'Initials': 'A', 'LastName': 'Raji', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Silvina', 'Initials': 'S', 'LastName': 'Gallo', 'Affiliation': 'Pfizer Pharma GmbH, Berlin, Germany.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Annpey', 'Initials': 'A', 'LastName': 'Pong', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Hakima', 'Initials': 'H', 'LastName': 'Hannachi', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': 'Pfizer Inc., Andover, Massachusetts, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22748']
673,32406312,High Salt Intake Augments Blood Pressure Responses During Submaximal Aerobic Exercise.,"Background High sodium (Na + ) intake is a widespread cardiovascular disease risk factor. High Na +  intake impairs endothelial function and exaggerates sympathetic reflexes, which may augment exercising blood pressure (BP) responses. Therefore, this study examined the influence of high dietary Na +  on BP responses during submaximal aerobic exercise. Methods and Results Twenty adults (8F/12M, age=24±4 years; body mass index 23.0±0.6 kg·m -2 ; VO 2 peak=39.7±9.8 mL·min -1 ·kg -1 ; systolic BP=111±10 mm Hg; diastolic BP=64±8 mm Hg) participated in this randomized, double-blind, placebo-controlled crossover study. Total Na +  intake was manipulated via ingestion of capsules containing either a placebo (dextrose) or table salt (3900 mg Na + /day) for 10 days each, separated by ≥2 weeks. On day 10 of each intervention, endothelial function was assessed via flow-mediated dilation followed by BP measurement at rest and during 50 minutes of cycling at 60% VO 2peak . Throughout exercise, BP was assessed continuously via finger photoplethysmography and every 5 minutes via auscultation. Venous blood samples were collected at rest and during the final 10 minutes of exercise for assessment of norepinephrine. High Na +  intake increased urinary Na +  excretion (placebo=140±68 versus Na + =282±70 mmol·24H -1 ;  P <0.001) and reduced flow-mediated dilation (placebo=7.2±2.4 versus Na + =4.2±1.7%;  P <0.001). Average exercising systolic BP was augmented following high Na +  (placebo=Δ30.0±16.3 versus Na + =Δ38.3±16.2 mm Hg;  P =0.03) and correlated to the reduction in flow-mediated dilation ( R =-0.71,  P =0.002). Resting norepinephrine concentration was not different between conditions ( P =0.82). Norepinephrine increased during exercise ( P =0.002), but there was no Na +  effect ( P =0.26). Conclusions High dietary Na +  augments BP responses during submaximal aerobic exercise, which may be mediated, in part, by impaired endothelial function.",2020,High Na +  intake increased urinary Na +  excretion (placebo=140±68 versus Na + =282±70 mmol·24H -1 ;  P <0.001) and reduced flow-mediated dilation (placebo=7.2±2.4 versus Na + =4.2±1.7%;  P <0.001).,"['Hg; diastolic BP=64±8\xa0mm\xa0Hg', 'Twenty adults (8F/12M']","[' High sodium (Na + ) intake', 'Norepinephrine', 'High Na +  intake', 'placebo (dextrose) or table salt (3900', 'High Salt Intake', 'high dietary Na ', 'placebo']","['BP responses', 'endothelial function', 'endothelial function and exaggerates sympathetic reflexes', 'Venous blood samples', 'reduction in flow-mediated dilation', 'exercising blood pressure (BP) responses', 'urinary Na +  excretion', 'Resting norepinephrine concentration', 'Average exercising systolic BP', 'reduced flow-mediated dilation']","[{'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0595879', 'cui_str': 'Sodium high'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0206136', 'cui_str': 'Dietary Sodium Chloride'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0442801', 'cui_str': 'Exaggerated'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",20.0,0.259216,High Na +  intake increased urinary Na +  excretion (placebo=140±68 versus Na + =282±70 mmol·24H -1 ;  P <0.001) and reduced flow-mediated dilation (placebo=7.2±2.4 versus Na + =4.2±1.7%;  P <0.001).,"[{'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Babcock', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}, {'ForeName': 'Austin T', 'Initials': 'AT', 'LastName': 'Robinson', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}, {'ForeName': 'Kamila U', 'Initials': 'KU', 'LastName': 'Migdal', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Watso', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Martens', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Edwards', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Pescatello', 'Affiliation': 'Department of Kinesiology University of Connecticut Storrs CT.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.015633']
674,32406343,Response to invited commentary : Vitamin D 3  supplementation for 8 weeks leads to improved haematological status following the consumption of an iron-fortified breakfast cereal: a double-blind randomised controlled trial in iron-deficient women.,,2020,,['iron-deficient women'],[],['haematological status'],"[{'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0449438', 'cui_str': 'Status'}]",,0.572926,,"[{'ForeName': 'Salma F', 'Initials': 'SF', 'LastName': 'Ahmad Fuzi', 'Affiliation': 'From the Faculty of Medicine, Dentistry and Life Sciences, University of Chester, Parkgate Road, Chester, UK, CH1 4BJ.'}, {'ForeName': 'Sohail', 'Initials': 'S', 'LastName': 'Mushtaq', 'Affiliation': 'From the Faculty of Medicine, Dentistry and Life Sciences, University of Chester, Parkgate Road, Chester, UK, CH1 4BJ.'}]",The British journal of nutrition,['10.1017/S0007114520001683']
675,32406371,Slow-oscillation activity is reduced and high frequency activity is elevated in older adults with insomnia.,"STUDY OBJECTIVES


High frequency electroencephalographic (EEG) activity (>16 Hz activity) is often elevated during non-rapid eye movement (NREM) sleep among individuals with insomnia, in line with the hyperarousal theory of insomnia. Evidence regarding sleep depth marked by slow-wave activity (<4 Hz) is more mixed. Distinguishing subcomponents of slow-wave activity (slow-oscillation (<1 Hz) or delta activity (1-4 Hz)) may be critical in understanding these discrepancies, given that these oscillations have different neural generators and are functionally distinct. Here we tested the effects of insomnia diagnosis and insomnia treatment on NREM EEG in older adults, distinguishing slow-oscillation and delta power.
METHODS


In 93 older adults with insomnia and 71 good sleeper control participants (mean ages 68), effects of insomnia and cognitive behavioral therapy for insomnia (CBTI) (insomnia group only) on EEG spectral power were analyzed. Main effects and interactions with NREM period were assessed for the following frequency bands: slow-oscillation (0.5-1 Hz), delta (1-4 Hz), theta (4-8 Hz), alpha (8-12 Hz), sigma (12-16Hz), and beta (16-32 Hz).
RESULTS


Slow-oscillation absolute and relative power were lower in the insomnia group compared with controls. There were no group differences in delta power. Insomnia was also associated with elevated 4-32 Hz absolute and relative power. After CBTI, absolute sigma and beta activity decreased.
CONCLUSIONS


Deficits in slow-wave activity in insomnia are specific to the slow-oscillation. Elevated high frequency activity is reduced for sigma and beta power following CBTI. These findings inform the pathophysiology of insomnia, including the mechanisms underlying CBTI in older adults.",2020,There were no group differences in delta power.,"['93 older adults with insomnia and 71 good sleeper control participants (mean ages 68), effects of insomnia and cognitive behavioral therapy for insomnia (CBTI) (insomnia group only) on EEG spectral power were analyzed', 'individuals with insomnia, in line with the hyperarousal theory of insomnia', 'older adults with insomnia', 'older adults']",['insomnia diagnosis and insomnia treatment'],"['delta power', 'Insomnia', 'absolute sigma and beta activity decreased', 'Slow-oscillation absolute and relative power']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C1719918', 'cui_str': 'Sigma'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",93.0,0.0414553,There were no group differences in delta power.,"[{'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Hogan', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Gisela M', 'Initials': 'GM', 'LastName': 'Delgado', 'Affiliation': ""St. Luke's Warren Campus, Phillipsburg, New Jersey.""}, {'ForeName': 'Martica H', 'Initials': 'MH', 'LastName': 'Hall', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Vishwajit L', 'Initials': 'VL', 'LastName': 'Nimgoankar', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Germain', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Buysse', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Kristine A', 'Initials': 'KA', 'LastName': 'Wilckens', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8568']
676,32403062,"The effect of viewing challenging ""reality check"" Instagram comments on women's body image.","One increasing trend on social media is the posting of challenging or ""reality check"" comments about idealized photos of thin and attractive women. The aim of the present study was to experimentally investigate the effect of viewing such reality check comments after a positive appearance comment on young women's body image. Participants were 192 women aged 17-25 years who were randomly assigned to view Instagram images accompanied by no comment, a positive appearance comment, or a reality check comment plus the positive appearance comment. In contrast to prediction, viewing positive appearance comments did not elicit more body dissatisfaction than viewing images with no comments. As predicted, however, adding a reality check comment did reduce body dissatisfaction relative to the positive appearance comment alone. It was concluded that making and viewing reality check comments provides a potential way for women to mitigate some of the negative effect of Instagram imagery.",2020,"Participants were 192 women aged 17-25 years who were randomly assigned to view Instagram images accompanied by no comment, a positive appearance comment, or a reality check comment plus the positive appearance comment.","[""young women's body image"", 'Participants were 192 women aged 17-25 years', ""women's body image""]","['view Instagram images accompanied by no comment, a positive appearance comment, or a reality check comment plus the positive appearance comment', 'viewing challenging ""reality check"" Instagram comments']",['body dissatisfaction'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0282411', 'cui_str': 'Editorial Comment'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}]",192.0,0.0251286,"Participants were 192 women aged 17-25 years who were randomly assigned to view Instagram images accompanied by no comment, a positive appearance comment, or a reality check comment plus the positive appearance comment.","[{'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Tiggemann', 'Affiliation': 'School of Psychology, Flinders University, GPO Box 2100, Adelaide, South Australia, 5001, Australia. Electronic address: Marika.Tiggemann@flinders.edu.au.'}, {'ForeName': 'Vasiliki Georgia', 'Initials': 'VG', 'LastName': 'Velissaris', 'Affiliation': 'School of Psychology, Flinders University, GPO Box 2100, Adelaide, South Australia, 5001, Australia.'}]",Body image,['10.1016/j.bodyim.2020.04.004']
677,32403066,A controlled clinical crossover trial of exercise training to improve cognition and neural communication in pediatric brain tumor survivors.,"OBJECTIVE


To assess the efficacy of aerobic exercise training to improve controlled attention, information processing speed and neural communication during increasing task load and rest in pediatric brain tumor survivors (PBTS) treated with cranial radiation.
METHODS


Participants completed visual-motor Go and Go/No-Go tasks during magnetoencephalography recording prior to and following the completion of 12-weeks of exercise training. Exercise-related changes in response accuracy and visual-motor latency were evaluated with Linear Mixed models. The Phase Lag Index (PLI) was used to estimate functional connectivity during task performance and rest. Changes in PLI values after exercise training were assessed using Partial Least Squares analysis.
RESULTS


Exercise training predicted sustained (12-weeks) improvement in response accuracy (p<0.05) during No-Go trials. Altered functional connectivity was detected in theta (4-7Hz) alpha (8-12Hz) and high gamma (60-100Hz) frequency bands (p<0.001) during Go and Go/No-Go trials. Significant changes in response latency and resting state connectivity were not detected.
CONCLUSION


These findings support the efficacy of aerobic exercise to improve controlled attention and enhance functional mechanisms under increasing task load in participants.
SIGNIFICANCE


It may be possible to harness the beneficial effects of exercise as therapy to promote cognitive recovery and enhance brain function in PBTS.",2020,Altered functional connectivity was detected in theta (4-7Hz) alpha (8-12Hz) and high gamma (60-100Hz) frequency bands (p<0.001) during Go and Go/No-Go trials.,"['pediatric brain tumor survivors (PBTS) treated with cranial radiation', 'Participants completed visual-motor Go and Go', 'pediatric brain tumor survivors']","['exercise training', 'aerobic exercise', 'Exercise training', 'aerobic exercise training']","['PLI values', 'Phase Lag Index (PLI', 'cognition and neural communication', 'response accuracy and visual-motor latency', 'response accuracy', 'Altered functional connectivity', 'response latency and resting state connectivity']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}]",,0.0354978,Altered functional connectivity was detected in theta (4-7Hz) alpha (8-12Hz) and high gamma (60-100Hz) frequency bands (p<0.001) during Go and Go/No-Go trials.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cox', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada; Department of Psychology, University of Toronto, 100 St. George Street, Toronto, ON M5S 3G3, Canada. Electronic address: elizabeth.cox@sickkids.ca.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Bells', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: sonya.bells@sickkids.ca.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Timmons', 'Affiliation': 'Department of Pediatrics, McMaster University, 1200 Main Street W., Hamilton, ON L8N 3Z5, Canada. Electronic address: timmonbw@mcmaster.ca.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Laughlin', 'Affiliation': 'Diagnostic Imaging, SickKids, 555 University Avenue, Toronto, ON M5G 1X8, Canada. Electronic address: suzanne.laughlin@sickkids.ca.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bouffet', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: eric.bouffet@sickkids.ca.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'de Medeiros', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: cynthia.demedeiros@sickkids.ca.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Beera', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: kirangbeera@gmail.com.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Harasym', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: harasyd@mcmaster.ca.'}, {'ForeName': 'Donald J', 'Initials': 'DJ', 'LastName': 'Mabbott', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada; Department of Psychology, University of Toronto, 100 St. George Street, Toronto, ON M5S 3G3, Canada. Electronic address: donald.mabbott@sickkids.ca.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.03.027']
678,32403115,Delayed iron does not alter cognition or behavior among children with severe malaria and iron deficiency.,"BACKGROUND


Malaria and iron deficiency (ID) in childhood are both associated with cognitive and behavioral dysfunction. The current standard of care for children with malaria and ID is concurrent antimalarial and iron therapy. Delaying iron therapy until inflammation subsides could increase iron absorption but also impair cognition.
METHODS


In this study, Ugandan children 18 months to 5 years old with cerebral malaria (CM, n = 79), severe malarial anemia (SMA, n = 77), or community children (CC, n = 83) were enrolled and tested for ID. Children with ID were randomized to immediate vs. 28-day delayed iron therapy. Cognitive and neurobehavioral outcomes were assessed at baseline and 6 and 12 months (primary endpoint) after enrollment.
RESULTS


All children with CM or SMA and 35 CC had ID (zinc protoporphyrin concentration ≥80 μmol/mol heme). No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06).
CONCLUSIONS


Children with CM or SMA and ID who received immediate vs. delayed iron therapy had similar cognitive and neurobehavioral outcomes at 12-month follow-up.
IMPACT


The optimal time to provide iron therapy in children with severe malaria is not known. The present study shows that delay of iron treatment to 28 days after the malaria episode, does not lead to worse cognitive or behavioral outcomes at 12-month follow-up.The study contributes new data to the ongoing discussion of how best to treat ID in children with severe malaria.",2020,"No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06).
","['children with severe malaria and iron deficiency', 'Ugandan children 18 months to 5 years old with cerebral malaria (CM, n\u2009=\u200979), severe malarial anemia (SMA, n\u2009=\u200977), or community children (CC, n\u2009=\u200983) were enrolled and tested for ID', 'Children with ID', 'children with severe malaria']",['immediate vs. 28-day delayed iron therapy'],"['cognitive and neurobehavioral outcomes', 'Cognitive and neurobehavioral outcomes', 'cognition or behavior', 'cognitive or behavioral outcomes', 'overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2747816', 'cui_str': 'Complicated malaria'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0024534', 'cui_str': 'Cerebral malaria'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",83.0,0.106877,"No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06).
","[{'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Ssemata', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Hickson', 'Affiliation': ""Division of General Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Ssenkusu', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Cusick', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Noeline', 'Initials': 'N', 'LastName': 'Nakasujja', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Robert O', 'Initials': 'RO', 'LastName': 'Opoka', 'Affiliation': 'Department of Pediatrics and Child Health, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kroupina', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Georgieff', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bangirana', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Chandy C', 'Initials': 'CC', 'LastName': 'John', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA. chjohn@iu.edu.'}]",Pediatric research,['10.1038/s41390-020-0957-8']
679,32403118,Proof of mechanism and target engagement of glutamatergic drugs for the treatment of schizophrenia: RCTs of pomaglumetad and TS-134 on ketamine-induced psychotic symptoms and pharmacoBOLD in healthy volunteers.,"Glutamate neurotransmission is a prioritized target for antipsychotic drug development. Two metabotropic glutamate receptor 2/3 (mGluR2/3) agonists (pomaglumetad [POMA] and TS-134) were assessed in two Phase Ib proof of mechanism studies of comparable designs and using identical clinical assessments and pharmacoBOLD methodology. POMA was examined in a randomized controlled trial under double-blind conditions for 10-days at doses of 80 or 320 mg/d POMA versus placebo (1:1:1 ratio). The TS-134 trial was a randomized, single-blind, 6-day study of 20 or 60 mg/d TS-134 versus placebo (5:5:2 ratio). Primary outcomes were ketamine-induced changes in pharmacoBOLD in the dorsal anterior cingulate cortex (dACC) and symptoms reflected on the Brief Psychiatric Rating Scale (BPRS). Both trials were conducted contemporaneously. 95 healthy volunteers were randomized to POMA and 63 to TS-134. High-dose POMA significantly reduced ketamine-induced BPRS total symptoms within and between-groups (p < 0.01, d = -0.41; p = 0.04, d = -0.44, respectively), but neither POMA dose significantly suppressed ketamine-induced dACC pharmacoBOLD. In contrast, low-dose TS-134 led to moderate to large within and between group reductions in both BPRS positive symptoms (p = 0.02, d = -0.36; p = 0.008, d = -0.82, respectively) and dACC pharmacoBOLD (p = 0.004, d = -0.56; p = 0.079, d = -0.50, respectively) using pooled across-study placebo data. High-dose POMA exerted significant effects on clinical symptoms, but not on target engagement, suggesting a higher dose may yet be needed, while the low dose of TS-134 showed evidence of symptom reduction and target engagement. These results support further investigation of mGluR2/3 and other glutamate-targeted treatments for schizophrenia.",2020,"High-dose POMA significantly reduced ketamine-induced BPRS total symptoms within and between-groups (p < 0.01, d ","['healthy volunteers', '95 healthy volunteers']","['POMA versus placebo', 'TS-134 versus placebo', 'Two metabotropic glutamate receptor 2/3 (mGluR2/3) agonists (pomaglumetad [POMA] and TS-134', 'ketamine']","['BPRS positive symptoms', 'dACC pharmacoBOLD', 'BPRS total symptoms', 'clinical symptoms', 'ketamine-induced changes in pharmacoBOLD in the dorsal anterior cingulate cortex (dACC) and symptoms reflected on the Brief Psychiatric Rating Scale (BPRS']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1098057', 'cui_str': 'poly(n-octyl methacrylate)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0206529', 'cui_str': 'Metabotropic Glutamate Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0029941', 'cui_str': 'Brief psychiatric rating scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}]",95.0,0.504117,"High-dose POMA significantly reduced ketamine-induced BPRS total symptoms within and between-groups (p < 0.01, d ","[{'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Kantrowitz', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Grinband', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Donald C', 'Initials': 'DC', 'LastName': 'Goff', 'Affiliation': 'Nathan Kline Institute, Orangeburg, NY, USA.'}, {'ForeName': 'Adrienne C', 'Initials': 'AC', 'LastName': 'Lahti', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Marder', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Kegeles', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Ragy R', 'Initials': 'RR', 'LastName': 'Girgis', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Sobeih', 'Affiliation': 'Nathan Kline Institute, Orangeburg, NY, USA.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Wall', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Tse-Hwei', 'Initials': 'TH', 'LastName': 'Choo', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Green', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Yvonne S', 'Initials': 'YS', 'LastName': 'Yang', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Junghee', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Horga', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'William Z', 'Initials': 'WZ', 'LastName': 'Potter', 'Affiliation': 'National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Javitt', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'Columbia University, New York, NY, USA. Jeffrey.Lieberman@nyspi.columbia.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0706-z']
680,32404130,"Effect of mobile text messages on antiretroviral medication adherence and patient retention in early HIV care: an open-label, randomized, single center study in south Florida.","BACKGROUND


People with HIV (PHIV) with limited access to health services often experience suboptimal antiretroviral therapy (ART) adherence. We investigated whether a daily text messaging intervention improves ART adherence and retention in early HIV care in PHIV in a south Florida hospital-based clinic.
METHODS


ART-naïve PHIV receiving care through the clinic's Ryan White HIV/AIDS Program were enrolled and randomly assigned to the intervention or control groups with a 1:1 ratio. The intervention group received a 1-way text message daily and the control group received standard care without receiving text message reminders for 6 months. HIV RNA and CD4 cell count were measured at baseline and post-intervention. Adherence to ART was defined as a visual analog scale of ≥ 90%. Retention in care was defined as continued engagement at study end.
RESULTS


94 ART-naïve patients were randomized and 83 (85.6%) completed the study, of which 44 were in the intervention group and 39 were in the control group. At the end of the 6-month study period, adherence to ART was 84.4% in the intervention group versus 73.5% in the control group (OR, 1.9; 95% CI 0.7-5.0; p = 0.194). Retention in care significantly improved in the intervention group compared to the control group with the odds of retention increasing by 20% (OR, 1.2; 95% CI 1.1-1.5; p = 0.006). Undetectable HIV RNA (< 50 copies/mL) was 86.7% in the intervention group versus 73.5% in the control group (OR, 2.3; 95% CI 0.8-6.9; p = 0.112). A significant increase in CD4 cell count and a decrease in HIV RNA were found at study end, with no differences between the two groups.
CONCLUSIONS


In this pilot study, a one-way daily text messaging intervention did not improve ART adherence over a 6-month study period, but significantly enhanced patient retention in early HIV care. Implementation of interventions to improve adherence in this population is required.",2020,"Retention in care significantly improved in the intervention group compared to the control group with the odds of retention increasing by 20% (OR, 1.2; 95% CI 1.1-1.5; p = 0.006).","['south Florida', '94 ART-naïve patients', 'People with HIV (PHIV) with limited access to health services often experience suboptimal antiretroviral therapy (ART) adherence', ""ART-naïve PHIV receiving care through the clinic's Ryan White HIV/AIDS Program"", 'early HIV care in PHIV in a south Florida hospital-based clinic', 'early HIV care']","['1-way text message daily and the control group received standard care without receiving text message reminders', 'mobile text messages', 'daily text messaging intervention']","['adherence to ART', 'CD4 cell count', 'HIV RNA and CD4 cell count', 'HIV RNA', 'Undetectable HIV RNA', 'ART adherence and retention', 'antiretroviral medication adherence and patient retention', 'ART adherence', 'Retention in care']","[{'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4704685', 'cui_str': 'Care Retention'}]",,0.124402,"Retention in care significantly improved in the intervention group compared to the control group with the odds of retention increasing by 20% (OR, 1.2; 95% CI 1.1-1.5; p = 0.006).","[{'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Sherman', 'Affiliation': 'Department of Pharmacy Practice, Nova Southeastern University College of Pharmacy, 3200 South University Drive, Fort Lauderdale, FL, 33328, USA. esherman@nova.edu.'}, {'ForeName': 'Jianli', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': 'Office of Human Research, Memorial Healthcare System, 3111 Stirling Road, Hollywood, FL, 33312, USA.'}, {'ForeName': 'Shara', 'Initials': 'S', 'LastName': 'Elrod', 'Affiliation': 'Department of Pharmacotherapy, University of North Texas System College of Pharmacy, 3500 Camp Bowie Boulevard, Fort Worth, TX, 76107, USA.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Clauson', 'Affiliation': 'Department of Pharmacy Practice, Lipscomb University College of Pharmacy, One University Park Drive, Nashville, TN, 37204, USA.'}, {'ForeName': 'Fadi', 'Initials': 'F', 'LastName': 'Alkhateeb', 'Affiliation': 'Qatar University College of Pharmacy, QU Health, Building Ibn Al-Bitar (I06), Doha, Qatar.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Eckardt', 'Affiliation': 'Division of Infectious Diseases, Memorial Healthcare System, 5647 Hollywood Boulevard, Hollywood, FL, 33021, USA.'}]",AIDS research and therapy,['10.1186/s12981-020-00275-2']
681,32404132,Rehabilitation of older people with Parkinson's disease: an innovative protocol for RCT study to evaluate the potential of robotic-based technologies.,"BACKGROUND


Parkinson's disease is one of the most frequent causes of disability among the older adults. It is a chronic-progressive neuro-degenerative disease, characterized by several motor disorders. Balance disorders are a symptom that involves the body axis and do not respond to dopaminergic therapy used in Parkinson's disease. Therefore, physiotherapy becomes an important intervention for the management of motor disorders. Originally, these rehabilitative approaches were based on empirical experiences, but several scientific evidences suggests that neuronal plasticity is exercise-dependent. In this context, robotic rehabilitation plays an important role because it allows to perform task-oriented exercises and to increase the number of repetitions and their intensity. This protocol study aims to evaluate the effectiveness of robotic-based intervention of the older adults with Parkinson's disease, designed to improve the gait and to reduce the risk of falling.
METHODS


This study is a single-blinded randomized controlled trial. The primary outcomes are: risk of falling, gait performance and fear of falling measured through Performance-Oriented Mobility Assessment (POMA), instrumental gait analysis and Short Falls Efficacy Scale - International (FES-I), respectively. One hundred ninety-five patients with PD will be recruited and randomly divided into three groups, to receive a traditional rehabilitation program or a robotic rehabilitation using Tymo system or Walker View in addition to the traditional therapy. Assessments will be performed at baseline, at the end of treatment and 6 months, 1 year and 2 years from the end of the treatment. A 10-treatment session will be conducted, divided into 2 training sessions per week, for 5 weeks. The control group will perform traditional therapy sessions lasting 50 min. The technological intervention group will carry out 30 min of traditional therapy and 20 min of treatment with a robotic system.
DISCUSSION


The final goals of the present study are to propose a new approach in the PD rehabilitation, focused on the use of robotic device, and to check the results not only at the end of the treatment but also in the long term.
TRIAL REGISTRATION


NCT04087031, registration date September 12, 2019.",2020,Balance disorders are a symptom that involves the body axis and do not respond to dopaminergic therapy used in Parkinson's disease.,"['One hundred ninety-five patients with PD', ""older people with Parkinson's disease"", ""older adults with Parkinson's disease""]","['traditional rehabilitation program or a robotic rehabilitation using Tymo system or Walker View in addition to the traditional therapy', 'robotic-based intervention']","['risk of falling, gait performance and fear of falling measured through Performance-Oriented Mobility Assessment (POMA), instrumental gait analysis and Short Falls Efficacy Scale - International (FES-I), respectively']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0043016', 'cui_str': 'Walker'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C2317515', 'cui_str': 'Assessment of mobility'}, {'cui': 'C0558820', 'cui_str': 'Examination of gait'}, {'cui': 'C2919878', 'cui_str': 'Short falls efficacy scale - international'}, {'cui': 'C0525959', 'cui_str': '16-fluoroestradiol, (16alpha, 17beta)-isomer, (18F)-labeled'}]",,0.0298868,Balance disorders are a symptom that involves the body axis and do not respond to dopaminergic therapy used in Parkinson's disease.,"[{'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Bevilacqua', 'Affiliation': 'Scientific Direction, IRCCS INRCA, Ancona, Italy. r.bevilacqua@inrca.it.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Maranesi', 'Affiliation': 'Scientific Direction, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Di Rosa', 'Affiliation': 'Unit of Geriatric Pharmacoepidemiology, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Luzi', 'Affiliation': 'Medical Direction, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Casoni', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Rinaldi', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Fermo, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Baldoni', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Fabrizia', 'Initials': 'F', 'LastName': 'Lattanzio', 'Affiliation': 'Scientific Direction, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Di Donna', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Fermo, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pelliccioni', 'Affiliation': 'Neurology Unit, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Giovanni Renato', 'Initials': 'GR', 'LastName': 'Riccardi', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy.'}]",BMC neurology,['10.1186/s12883-020-01759-4']
682,32404133,Efficacy of a physical activity programme combining individualized aerobic exercise and coaching to improve physical fitness in neuromuscular diseases (I'M FINE): study protocol of a randomized controlled trial.,"BACKGROUND


In individuals with neuromuscular diseases (NMD), symptoms of muscle weakness, fatigue and pain may limit physical activity. Inactivity leads to reduced physical fitness, which further complicates daily life functioning. Due to inconclusive evidence regarding exercise in NMD, the optimal training approach and strategies to preserve an active lifestyle remain to be determined. The physical activity programme I'M FINE, consisting of individualized aerobic exercise to improve physical fitness and coaching to preserve an active lifestyle, was therefore developed. The primary objective of this study will be to evaluate the efficacy of the I'M FINE programme in terms of improved physical fitness in individuals with slowly progressive NMD, compared to usual care.
METHODS


A multicentre, assessor-blinded, two armed, randomized controlled trial will be conducted in a sample of 90 individuals with slowly progressive NMD. Participants motivated to improve their reduced physical fitness will be randomized (ratio 1:1) to the I'M FINE intervention or usual care. The I'M FINE intervention consists of a six-month physical activity programme, including individualized home-based aerobic exercise to improve physical fitness (i.e. peak oxygen uptake), and motivational interviewing coaching (e.g. goal setting, self-management) to adopt and preserve an active lifestyle. Measurements will be performed at baseline, post-intervention, and at 12- and 18-months follow-up. The primary outcome is peak oxygen uptake (VO 2  peak) directly post intervention. Main secondary outcomes are physical capacity, muscle strength, self-efficacy, daily activity, quality of life and markers of metabolic syndrome. The primary analysis compares change in VO 2  peak post-intervention between the intervention and usual care group, with analysis of covariance.
DISCUSSION


The I'M FINE study will provide evidence regarding the efficacy of a physical activity intervention on the physical fitness and active lifestyle over the short- and long-term in individuals with slowly progressive NMD. These outcomes could potentially improve the (inter)national guidelines for efficacy of aerobic exercise programmes and provide insight in achieving a more active lifestyle in NMD.
TRIAL REGISTRATION


(5/11/2018): Netherlands Trial Register NTR7609 (retrospectively registered), https://www.trialregister.nl/trial/7344. However, the Ethics Review Committee of the Amsterdam Medical Center (AMC) approved the study protocol on 7/11/2017. No adjustments were made to the approved study protocol before the first participant enrolment and registration. Registration was done after the second participant enrolment and the information in the register corresponds one on one with the approved study protocol.",2020,"The I'M FINE intervention consists of a six-month physical activity programme, including individualized home-based aerobic exercise to improve physical fitness (i.e. peak oxygen uptake), and motivational interviewing coaching (e.g. goal setting, self-management) to adopt and preserve an active lifestyle.","['individuals with slowly progressive NMD', 'individuals with neuromuscular diseases (NMD', ""neuromuscular diseases (I'M FINE"", '90 individuals with slowly progressive NMD']","['physical activity intervention', ""I'M FINE programme"", 'physical activity programme combining individualized aerobic exercise and coaching', 'aerobic exercise programmes', 'individualized home-based aerobic exercise to improve physical fitness (i.e. peak oxygen uptake), and motivational interviewing coaching (e.g. goal setting, self-management) to adopt and preserve an active lifestyle', 'individualized aerobic exercise']","['physical fitness', 'peak oxygen uptake (VO 2  peak', 'physical capacity, muscle strength, self-efficacy, daily activity, quality of life and markers of metabolic syndrome']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0027868', 'cui_str': 'Myoneural disorder'}, {'cui': 'C0205232', 'cui_str': 'Fine'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]",90.0,0.0860636,"The I'M FINE intervention consists of a six-month physical activity programme, including individualized home-based aerobic exercise to improve physical fitness (i.e. peak oxygen uptake), and motivational interviewing coaching (e.g. goal setting, self-management) to adopt and preserve an active lifestyle.","[{'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Oorschot', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands. s.oorschot@amsterdamumc.nl.'}, {'ForeName': 'Merel A', 'Initials': 'MA', 'LastName': 'Brehm', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Annerieke C', 'Initials': 'AC', 'LastName': 'van Groenestijn', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Fieke S', 'Initials': 'FS', 'LastName': 'Koopman', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Camiel', 'Initials': 'C', 'LastName': 'Verhamme', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Eftimov', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Judith G M', 'Initials': 'JGM', 'LastName': 'Jelsma', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam UMC, VU University Medical Center, de Boelelaan 1118, Amsterdam, The Netherlands.'}, {'ForeName': 'Harald T', 'Initials': 'HT', 'LastName': 'Jorstad', 'Affiliation': 'Department of Cardiology, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Nollet', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Voorn', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}]",BMC neurology,['10.1186/s12883-020-01725-0']
683,32404169,"Prevention of acute radiation-induced Proctitis by Aloe vera: a prospective randomized, double-blind, placebo controlled clinical trial in Pelvic Cancer patients.","BACKGROUND


Acute radiation-induced proctitis (ARP) is the most common side effect following radiotherapy for malignant pelvic disease. This study evaluated the efficacy of Aloe vera ointment in prevention of ARP.
METHODS


Forty-two patients receiving external-beam radiotherapy (RT) for pelvic malignancies were randomized to receive either Aloe vera 3% or placebo topical ointment during radiotherapy for 6 weeks. These patients were evaluated based on the severity (grade 0-4) of the following symptoms weekly: rectal bleeding, abdominal/rectal pain, diarrhea, or fecal urgency. RTOG acute toxicity criteria and psychosocial status of the patients were also recorded weekly. Lifestyle impact of the symptoms, and quantitative measurement of C-reactive protein (CRP), an indicator of systemic inflammation, were also measured.
RESULTS


The results of present study demonstrated a significant preventive effect for Aloe vera in occurrence of symptom index for diarrhea (p < 0.001), rectal bleeding (p < 0.001), and fecal urgency (p = 0.001). The median lifestyle score improved significantly with Aloe vera during RT (p < 0.001). Intervention patients had a significant lower burden of systemic inflammation as the values for quantitative CRP decreased significantly over 6 weeks of follow-up (p = 0.009).
CONCLUSION


This study showed that Aloe vera topical ointment was effective in prevention of symptoms of ARP in patients undergoing RT for pelvic cancers.
TRIAL REGISTRATION


IRCT201606042027N6. Registration date: 2016-09-04.",2020,"Intervention patients had a significant lower burden of systemic inflammation as the values for quantitative CRP decreased significantly over 6 weeks of follow-up (p = 0.009).
","['patients undergoing RT for pelvic cancers', 'for pelvic malignancies', 'Pelvic Cancer patients', 'Forty-two patients receiving']","['external-beam radiotherapy (RT', 'radiotherapy', 'Aloe vera topical ointment', 'Aloe vera 3% or placebo topical ointment during radiotherapy', 'Aloe vera ointment', 'acute radiation-induced Proctitis by Aloe vera', 'placebo']","['RTOG acute toxicity criteria and psychosocial status', 'median lifestyle score', 'rectal bleeding, abdominal/rectal pain, diarrhea, or fecal urgency', 'burden of systemic inflammation', 'fecal urgency', 'prevention of symptoms of ARP', 'symptom index for diarrhea', 'quantitative CRP', 'rectal bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0751416', 'cui_str': 'Pelvic Cancer'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C4319566', 'cui_str': '42'}]","[{'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0718405', 'cui_str': 'Aloe vera'}, {'cui': 'C0991554', 'cui_str': 'Cutaneous ointment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0400827', 'cui_str': 'Radiation proctitis'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0337459', 'cui_str': 'Psychosocial status'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0034886', 'cui_str': 'Rectal pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0426636', 'cui_str': 'Urgent desire for stool'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0400827', 'cui_str': 'Radiation proctitis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",42.0,0.424109,"Intervention patients had a significant lower burden of systemic inflammation as the values for quantitative CRP decreased significantly over 6 weeks of follow-up (p = 0.009).
","[{'ForeName': 'Adeleh', 'Initials': 'A', 'LastName': 'Sahebnasagh', 'Affiliation': 'Clinical Research Center, Department of Internal Medicine, Faculty of Medicine, North Khorasan University of Medical Sciences, Bojnurd, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Ghasemi', 'Affiliation': 'Emam Khomeini Hospital, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Jafar', 'Initials': 'J', 'LastName': 'Akbari', 'Affiliation': 'Pharmaceutical Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Alipour', 'Affiliation': 'Epidemiology, Faculty of Medicine, Community medicine Department, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Lashkardoost', 'Affiliation': 'School of Public Health, North Khorasan University of Medical Sciences, Bojnurd, I.R, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Ala', 'Affiliation': 'Pharmaceutical Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Seyed Jalal', 'Initials': 'SJ', 'LastName': 'Hosseinimehr', 'Affiliation': 'Department of Radiopharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Salehifar', 'Affiliation': 'Gastrointestinal Cancer Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran. salehifare@yahoo.com.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-02935-2']
684,32405121,Does moral reasoning influence public values for health care priority setting?: A population-based randomized stated preference survey.,"Objective


Preferences of members of the public are recognized as important inputs into health care priority-setting, though knowledge of such preferences is scant. We sought to generate evidence of public preferences related to healthcare resource allocation among adults and children.
Methods


We conducted an experimental stated preference survey in a national sample of Canadian adults. Preferences were elicited across a range of scenarios and scored on a visual analogue scale. Intervention group participants were randomized to a moral reasoning exercise prior to each choice task. The main outcomes were the differences in mean preference scores by group, scenario, and demographics.
Results


Our results demonstrate a consistent preference by participants to allocate scarce health system resources to children. Exposure to the moral reasoning exercise weakened but did not eliminate this preference. Younger respondent age and parenthood were associated with greater preference for children. The top principles guiding participants' allocative decisions were treat equally, relieve suffering, and rescue those at risk of dying.
Conclusions


Our study affirms the relevance of age in public preferences for the allocation of scarce health care resources, demonstrating a significant preference by participants to allocate healthcare resources to children. However, this preference diminishes when challenged by exposure to a range of moral principles, revealing a strong public endorsement of equality of access. Definitions of value in healthcare based on clinical benefit and cost-effectiveness may exclude moral considerations that the public values, such as equality and humanitarianism, highlighting opportunities to enrich healthcare priority-setting through public engagement.",2020,"However, this preference diminishes when challenged by exposure to a range of moral principles, revealing a strong public endorsement of equality of access.","['experimental stated preference survey in a national sample of Canadian adults', 'adults and children']","['moral reasoning exercise', 'moral reasoning exercise prior to each choice task']","['mean preference scores by group, scenario, and demographics']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",,0.0701692,"However, this preference diminishes when challenged by exposure to a range of moral principles, revealing a strong public endorsement of equality of access.","[{'ForeName': 'Avram E', 'Initials': 'AE', 'LastName': 'Denburg', 'Affiliation': 'Department of Paediatrics, The Hospital for Sick Children, University of Toronto, Toronto, M5G 1X8, Canada.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Ungar', 'Affiliation': 'Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, M5T 3M6, Canada.'}, {'ForeName': 'Shiyi', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Biostatistician, Biostatistics, Design and Analysis, Peter Gilgan Centre for Research and Learning, The Hospital for Sick Children, Toronto, M5G 1X8, Canada.'}, {'ForeName': 'Jeremiah', 'Initials': 'J', 'LastName': 'Hurley', 'Affiliation': 'Department of Economics, McMaster University, Hamilton, L8S 4L8, Canada.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Abelson', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, L8S 4L8, Canada.'}]","Health policy (Amsterdam, Netherlands)",['10.1016/j.healthpol.2020.04.007']
685,32405176,Role of Granulocyte Colony Stimulating Factor on the Short-Term Outcome of Children with Acute on Chronic Liver Failure.,"Background


Acute-on-chronic liver failure (ACLF) results in very high mortality in children. We aimed to evaluate the role of granulocyte colony-stimulating factor (GCSF) on short-term outcome of children with ACLF in a nontransplant unit.
Methods


Children (aged > 1 year) diagnosed with ACLF over a 15 month period were randomised. Group A was given GCSF therapy along with standard medical care (SMC - details in supplementary data) and group B was given only SMC. The outcome was evaluated as survival at 30 and 60 days of therapy.
Result


Thirty-one children with ACLF were enrolled, with a mean age of 6.92 ± 4.3yrs. A total of 15 patients were randomised to group A and 16 to group B. The overall mortality was 54.83%. The intervention group showed survival rates of 80%, 66.67% and 53.3%, whereas the control group had survival rates of 43.75%, 37.5% and 37.5% at 14, 30 and 60 days, respectively. A significant survival benefit was noted on day 14 (p = 0.043) of therapy in group A with significant difference in Child-Turcotte-Pugh (CTP) and pediatric end-stage liver disease (PELD) scores in the two groups. After an initial rise in group A, the granulocyte counts fell to become comparable in the two groups by day 30 and 60, indicating that the effect of GCSF therapy wears off over time. There was no significant difference in the overall survival, median/mean CTP, PELD and MCS (Modified Cliff sequential organ failure assesment (SOFA)) scores on day 30 and 60. Mean (%) CD 34 + cells level showed a rise on day 7 in group A but was statistically insignificant.
Conclusion


The present study shows that GCSF therapy at 5 mcg/kg/day for 5 days seems to be ineffective in improving the survival outcome on day 30 and 60 of therapy. Studies with larger number of children enrolled and longer duration of therapy are required. (CTRI/2017/11/010420).",2020,"The intervention group showed survival rates of 80%, 66.67% and 53.3%, whereas the control group had survival rates of 43.75%, 37.5% and 37.5% at 14, 30 and 60 days, respectively.","['Methods\n\n\nChildren (aged\xa0>\xa01 year) diagnosed with ACLF over a 15 month period were randomised', 'children', 'Children with Acute on Chronic Liver Failure', '15 patients', 'children with ACLF in a nontransplant unit', 'Result\n\n\nThirty-one children with ACLF were enrolled, with a mean age of 6.92\xa0±\xa04.3yrs']","['granulocyte colony-stimulating factor (GCSF', 'Granulocyte Colony Stimulating Factor', 'Modified Cliff sequential organ failure assesment (SOFA', 'GCSF therapy along with standard medical care (SMC - details in supplementary data) and group B was given only SMC', 'GCSF therapy']","['Child-Turcotte-Pugh (CTP) and pediatric end-stage liver disease (PELD) scores', 'granulocyte counts fell', 'overall survival, median/mean CTP, PELD and MCS ', 'survival rates', 'survival outcome', 'survival benefit', 'survival', 'overall mortality']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3850141', 'cui_str': 'Acute on chronic liver failure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442530', 'cui_str': 'Cliff'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0860380', 'cui_str': 'G-CSF therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0745744', 'cui_str': 'End stage liver disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0857490', 'cui_str': 'Granulocyte count'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",31.0,0.064512,"The intervention group showed survival rates of 80%, 66.67% and 53.3%, whereas the control group had survival rates of 43.75%, 37.5% and 37.5% at 14, 30 and 60 days, respectively.","[{'ForeName': 'Shruti', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Division of Paediatric Gastroenterology, Hepatology & Nutrition, Post Graduate Institute of Medical Education & Research, Chandigarh, 160012, India.'}, {'ForeName': 'Sadhna B', 'Initials': 'SB', 'LastName': 'Lal', 'Affiliation': 'Division of Paediatric Gastroenterology, Hepatology & Nutrition, Post Graduate Institute of Medical Education & Research, Chandigarh, 160012, India.'}, {'ForeName': 'Manupdesh', 'Initials': 'M', 'LastName': 'Sachdeva', 'Affiliation': 'Department of Hematology, Post Graduate Institute of Medical Education & Research, Chandigarh, 160012, India.'}, {'ForeName': 'Anmol', 'Initials': 'A', 'LastName': 'Bhatia', 'Affiliation': 'Division of Paediatric Radiology, Post Graduate Institute of Medical Education & Research, Chandigarh, 160012, India.'}, {'ForeName': 'Neelam', 'Initials': 'N', 'LastName': 'Varma', 'Affiliation': 'Department of Hematology, Post Graduate Institute of Medical Education & Research, Chandigarh, 160012, India.'}]",Journal of clinical and experimental hepatology,['10.1016/j.jceh.2019.10.001']
686,32405286,Personalizing Mobile Fitness Apps using Reinforcement Learning.,"Despite the vast number of mobile fitness applications (apps) and their potential advantages in promoting physical activity, many existing apps lack behavior-change features and are not able to maintain behavior change motivation. This paper describes a novel fitness app called CalFit, which implements important behavior-change features like dynamic goal setting and self-monitoring. CalFit uses a reinforcement learning algorithm to generate personalized daily step goals that are challenging but attainable. We conducted the Mobile Student Activity Reinforcement (mSTAR) study with 13 college students to evaluate the efficacy of the CalFit app. The control group (receiving goals of 10,000 steps/day) had a decrease in daily step count of 1,520 (SD ± 740) between baseline and 10-weeks, compared to an increase of 700 (SD ± 830) in the intervention group (receiving personalized step goals). The difference in daily steps between the two groups was 2,220, with a statistically significant  p  = 0.039.",2018,"The difference in daily steps between the two groups was 2,220, with a statistically significant  p  = 0.039.",['13 college students'],['Mobile Student Activity Reinforcement (mSTAR'],['daily steps'],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]",,0.018296,"The difference in daily steps between the two groups was 2,220, with a statistically significant  p  = 0.039.","[{'ForeName': 'Mo', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'Department of Industrial Engineering and Operations Research University of California, Berkeley, CA, USA.'}, {'ForeName': 'Yonatan', 'Initials': 'Y', 'LastName': 'Mintz', 'Affiliation': 'Department of Industrial Engineering and Operations Research University of California, Berkeley, CA, USA.'}, {'ForeName': 'Yoshimi', 'Initials': 'Y', 'LastName': 'Fukuoka', 'Affiliation': 'Department of Physiological Nursing Institute for Health & Aging, School of Nursing University of California, San Francisco, CA, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Goldberg', 'Affiliation': 'Department of Industrial Engineering and Operations Research University of California, Berkeley, CA, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Flowers', 'Affiliation': 'Department of Physiological Nursing, School of Nursing University of California, San Francisco, CA, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Kaminsky', 'Affiliation': 'Department of Industrial Engineering and Operations Research University of California, Berkeley, CA, USA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Castillejo', 'Affiliation': 'Department of Industrial Engineering and Operations Research University of California, Berkeley, CA, USA.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Aswani', 'Affiliation': 'Department of Industrial Engineering and Operations Research University of California, Berkeley, CA, USA.'}]",CEUR workshop proceedings,[]
687,32405431,Phosphorus supplementation raised the heart rate of male water polo players during a randomised graded dryland exercise test.,"Objective


The impact of phosphorus supplementation on athletic performance is unclear. Ingestion of phosphorus for several days has been reported to increase cardiac capacity, improve oxygen muscle kinetics and enhance lactate buffering capacity. Recent studies have shown that phosphorus ingestion with a meal increases postprandial glucose uptake and thermogenesis. The present study aimed to assess the effect of acute phosphorus ingestion with a meal on specific workload parameters.
Methods


A double-blind, crossover trial of 12 male water polo players between 18 and 22 years old was conducted. Overnight fasted subjects were asked to cycle for 20 min before ingesting 100 g of glucose with phosphorus or placebo (400 mg). Three hours later, they were asked to perform a graded cycling exercise for 25 min.
Results


Expenditure, respiratory quotient, perception of fatigue and exercise efficiency were similar between treatments. However, heart rate was significantly higher in the phosphorus group (142±10 beats/min) compared with placebo (135±10 beats/min).
Conclusion


Exercise performance 3 hours after the coingestion of glucose with phosphorus did not affect substrate use, while heart rate was increased. The heart rate increase could be attributed to a rise in core body temperature.
Trial registration number


NCT03101215.",2020,"Results


Expenditure, respiratory quotient, perception of fatigue and exercise efficiency were similar between treatments.","['12 male water polo players between 18 and 22 years old was conducted', 'Overnight fasted subjects', 'male water polo players']","['glucose with phosphorus or placebo', 'phosphorus supplementation', 'placebo', 'Phosphorus supplementation']","['Results\n\n\nExpenditure, respiratory quotient, perception of fatigue and exercise efficiency', 'postprandial glucose uptake and thermogenesis', 'heart rate']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C2712390', 'cui_str': 'Water Polo'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",12.0,0.21514,"Results


Expenditure, respiratory quotient, perception of fatigue and exercise efficiency were similar between treatments.","[{'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Elhusseini', 'Affiliation': 'Department of Nutrition and Food Sciences, Faculty of Agricultural and Food Sciences, American University of Beirut, Beirut, Lebanon.'}, {'ForeName': 'Elie-Jacques', 'Initials': 'EJ', 'LastName': 'Fares', 'Affiliation': 'Department of Nutrition and Food Sciences, Faculty of Agricultural and Food Sciences, American University of Beirut, Beirut, Lebanon.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Obeid', 'Affiliation': 'Department of Nutrition and Food Sciences, Faculty of Agricultural and Food Sciences, American University of Beirut, Beirut, Lebanon.'}]",BMJ open sport & exercise medicine,['10.1136/bmjsem-2019-000714']
688,32405474,Listening to music during arteriovenous fistula surgery alleviates anxiety: A randomized single-blind clinical trial.,"BACKGROUND


Both end-stage renal disease and being wait-listed for a kidney transplant are anxiety-causing situations. Wait-listed patients usually require arteriovenous fistula surgery for dialysis access. This procedure is performed under local anesthesia. We investigated the effects of music on the anxiety, perceived pain and satisfaction levels of patients who underwent fistula surgery.
AIM


To investigate the effect of music therapy on anxiety levels and perceived pain of patients undergoing fistula surgery.
METHODS


Patients who were on a waiting list for kidney transplants and scheduled for fistula surgery were randomized to control and music groups. The music group patients listened to music throughout the fistula surgery. The State-Trait Anxiety Inventory was performed to assess anxiety, additionally visual analog scale was used to evaluate perceived pain, willingness to repeat the procedure and patient satisfaction. Demographic features, comorbidities, surgical history, basic surgical data (location of fistula creation, duration of surgery, incision length) and intra-operative hemodynamic parameters were recorded by an investigator blinded to the study group. An additional trait anxiety assessment was performed following the surgery.
RESULTS


There was a total of 55 patients included in the study. However, 14 patients did not fulfill the criteria due to requirement of sedation during surgery or uncompleted questionnaires. The remaining 41 patients were included in the analysis. There were 26 males and 15 females. The control and music groups consisted of 20 and 21 patients, respectively. With regard to basic surgical and demographic data, there was no difference between the groups. Overall patient satisfaction was significantly higher and intra-operative heart rate and blood pressure were significantly lower in the music group ( P  < 0.05). Postoperative state anxiety levels were significantly lower in the music group.
CONCLUSION


Music therapy can be a complimentary treatment for patients undergoing fistula surgery. It can reduce anxiety and perceived pain, improve intraoperative hemodynamic parameters and enhance treatment satisfaction, thus may contribute to better compliance of the patients.",2020,Overall patient satisfaction was significantly higher and intra-operative heart rate and blood pressure were significantly lower in the music group ( P  < 0.05).,"['Patients who were on a waiting list for kidney transplants and scheduled for fistula surgery', 'patients undergoing fistula surgery', '26 males and 15 females', '55 patients included in the study', 'patients who underwent fistula surgery']","['music therapy', 'Music therapy', 'music group patients listened to music throughout the fistula surgery', 'Listening to music during arteriovenous fistula surgery alleviates anxiety']","['Postoperative state anxiety levels', 'anxiety and perceived pain', 'anxiety, perceived pain and satisfaction levels', 'intra-operative heart rate and blood pressure', 'Overall patient satisfaction', 'Demographic features, comorbidities, surgical history, basic surgical data (location of fistula creation, duration of surgery, incision length) and intra-operative hemodynamic parameters', 'anxiety levels and perceived pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}]","[{'cui': 'C0231287', 'cui_str': 'Postoperative state'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0441513', 'cui_str': 'Construction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",55.0,0.104138,Overall patient satisfaction was significantly higher and intra-operative heart rate and blood pressure were significantly lower in the music group ( P  < 0.05).,"[{'ForeName': 'Sanem Guler', 'Initials': 'SG', 'LastName': 'Cimen', 'Affiliation': 'Department of General Surgery, Diskapi Research and Training Hospital, Health Sciences University, Ankara 06110, Turkey. s.cimen@dal.ca.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Oğuz', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Diskapi Research and Training Hospital, Health Sciences University, Ankara 06110, Turkey.'}, {'ForeName': 'Ayse Gokcen', 'Initials': 'AG', 'LastName': 'Gundogmus', 'Affiliation': 'Department of Psychiatry, Diskapi Research and Traning Hospital, Health Sciences University, Ankara 06110, Turkey.'}, {'ForeName': 'Sertac', 'Initials': 'S', 'LastName': 'Cimen', 'Affiliation': 'Department of Urology, Diskapi Research and Traning Hospital, Health Sciences University, Ankara 06110, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Sandikci', 'Affiliation': 'Department of Urology, Diskapi Research and Traning Hospital, Health Sciences University, Ankara 06110, Turkey.'}, {'ForeName': 'Mehmet Deniz', 'Initials': 'MD', 'LastName': 'Ayli', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Diskapi Research and Training Hospital, Health Sciences University, Ankara 06110, Turkey.'}]",World journal of transplantation,['10.5500/wjt.v10.i4.79']
689,31701308,Comparison of single minimum dose administration of dexmedetomidine and midazolam for prevention of emergence delirium in children: a randomized controlled trial.,"PURPOSE


Emergence delirium (ED) is common in children after sevoflurane anesthesia and should be prevented for patient safety. A prospective, double-blind, randomized, controlled study was performed to compare the efficacy of minimal dosage of midazolam versus dexmedetomidine to prevent ED in children undergoing tonsillectomy.
METHODS


Seventy children aged 24 months to 12 years were allocated to receive midazolam (0.03 mg/kg) or dexmedetomidine (0.3 µg/kg) 5 min before the end of surgery. The incidence and severity of ED were assessed using a four-point scale and the pediatric anesthesia emergence delirium scale, respectively. The emergence time and postoperative pain scores were also evaluated.
RESULTS


The incidence of ED was 31.3% in the midazolam group and 26.5% in the dexmedetomidine group (P = 0.668). The severity of ED was similar in both groups (9.6 ± 5.8 in the midazolam group, vs. 8.1 ± 5.9 in the dexmedetomidine group, P = 0.299). The emergence time was comparable in the two groups [11.0 (8.3-13.8) min in midazolam group vs. 12.0 (10.0-13.5) min in dexmedetomidine group (P = 0.218)]. Postoperative pain score was higher in the midazolam group [0 (0-1)] than in the dexmedetomidine group [0 (0-0)] (P = 0.011).
CONCLUSION


Dexmedetomidine and midazolam at single minimum dosages had equal effectiveness to prevent ED in children without delaying emergence time, when administered at the end of surgery. With regards to postoperative analgesic efficacy, although dexmedetomidine showed statistically significant higher analgesic effect than midazolam, further clinical investigations are needed to validate our findings.",2020,"With regards to postoperative analgesic efficacy, although dexmedetomidine showed statistically significant higher analgesic effect than midazolam, further clinical investigations are needed to validate our findings.","['children', 'children undergoing tonsillectomy', 'Seventy children aged 24\xa0months to 12\xa0years', 'children after']","['dexmedetomidine', 'midazolam', 'Dexmedetomidine and midazolam', 'sevoflurane anesthesia', 'dexmedetomidine and midazolam']","['emergence time and postoperative pain scores', 'severity of ED', 'Postoperative pain score', 'incidence and severity of ED', 'incidence of ED', 'analgesic effect', 'emergence time', 'postoperative analgesic efficacy']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}]",70.0,0.26482,"With regards to postoperative analgesic efficacy, although dexmedetomidine showed statistically significant higher analgesic effect than midazolam, further clinical investigations are needed to validate our findings.","[{'ForeName': 'Eun-Ah', 'Initials': 'EA', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea.'}, {'ForeName': 'Yun-Byeong', 'Initials': 'YB', 'LastName': 'Cha', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea.'}, {'ForeName': 'Jae-Geum', 'Initials': 'JG', 'LastName': 'Shim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea.'}, {'ForeName': 'Jin-Hee', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea.'}, {'ForeName': 'Sung Hyun', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea.'}, {'ForeName': 'Kyoung-Ho', 'Initials': 'KH', 'LastName': 'Ryu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea. kh.ryu@skku.edu.'}]",Journal of anesthesia,['10.1007/s00540-019-02705-6']
690,31030379,The effect of a single irradiation of low-level laser on nipple pain in breastfeeding women: a randomized controlled trial.,"Photobiomodulation with low-level laser therapy (PBM-LLLT) has been introduced as a new tool to relieve nipple pain and repair nipple damage in breastfeeding women; however, evidence is needed to assess its effectiveness. The aim was to evaluate the effect of a single application of PBM-LLLT for breastfeeding women with nipple pain and damage; side effects were also collected. We conducted a randomized double-blinded controlled trial with women with nipple damage who were exclusively breastfeeding and rooming-in at Amparo Maternal maternity service, São Paulo, Brazil (May 2016 to May 2017). Women were randomly assigned into laser (n = 40) or control group (n = 40). Intervention was a single irradiation (660 nm, 100 mW, 2 J, 66.66 J/cm 2 , 3.3 W/cm 2 , 20 s of irradiation, punctual, and continuous mode) applied directly. Women reported pain levels at recruitment (before and immediately after irradiation), 6 and 24 h after the treatment. Pain level during a breastfeed was assessed using the Visual Analogue Scale (0 to 10). The primary outcome was the level of nipple pain immediately after the laser irradiation. Data were analyzed using hierarchical model and Wald test. At baseline, pain levels were similar (mean of 7.4 in laser group and 7.1 in control group). Women's perception of pain reduced approximately one point in both groups. Thirty-one percent of participants in the laser group (11/36) reported secondary effects, such as tingling (10/36) and pricking (2/36). The laser protocol of a single application was not effective in reducing pain in women with damaged nipples. Tingling sensation may be experienced by women receiving laser treatment for nipple damage.",2020,"At baseline, pain levels were similar (mean of 7.4 in laser group and 7.1 in control group).","['women with nipple damage who were exclusively breastfeeding and rooming-in at Amparo Maternal maternity service, São Paulo, Brazil (May 2016 to May 2017', 'breastfeeding women', 'women with damaged nipples', 'breastfeeding women with nipple pain and damage']","['Photobiomodulation with low-level laser therapy (PBM-LLLT', 'PBM-LLLT', 'single irradiation of low-level laser']","['Tingling sensation', 'pain', 'level of nipple pain', 'Visual Analogue Scale', 'nipple pain', 'Pain level', 'pain levels', ""Women's perception of pain""]","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0457424', 'cui_str': 'Nippled (qualifier value)'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0423637', 'cui_str': 'Sore nipple (finding)'}]","[{'cui': 'C0279027', 'cui_str': 'Low-Power Laser Therapy'}, {'cui': 'C0071006', 'cui_str': 'phytobacteriomycin'}, {'cui': 'C4019433', 'cui_str': 'LLLT'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}]","[{'cui': 'C2242996', 'cui_str': 'Tingling'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0423637', 'cui_str': 'Sore nipple (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.371076,"At baseline, pain levels were similar (mean of 7.4 in laser group and 7.1 in control group).","[{'ForeName': 'Bárbara Tideman Sartorio', 'Initials': 'BTS', 'LastName': 'Camargo', 'Affiliation': ""Women's Health Nursing Department, Escola Paulista de Enfermagem, Universidade Federal de São Paulo, R. Napoleão de Barros, 754 - Vila Clementino, São Paulo, SP, 04024-002, Brazil.""}, {'ForeName': 'Kelly Pereira', 'Initials': 'KP', 'LastName': 'Coca', 'Affiliation': ""Women's Health Nursing Department, Escola Paulista de Enfermagem, Universidade Federal de São Paulo, R. Napoleão de Barros, 754 - Vila Clementino, São Paulo, SP, 04024-002, Brazil. kcoca@unifesp.br.""}, {'ForeName': 'Lisa Helen', 'Initials': 'LH', 'LastName': 'Amir', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Corrêa', 'Affiliation': 'Department of Oral Pathology, School of Dentistry, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ana Cecília Corrêa', 'Initials': 'ACC', 'LastName': 'Aranha', 'Affiliation': 'Department of Restorative Dentistry Special Laboratory of Lasers in Dentistry (LELO), School of Dentistry, Universidade de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Karla Oliveira', 'Initials': 'KO', 'LastName': 'Marcacine', 'Affiliation': ""Women's Health Nursing Department, Escola Paulista de Enfermagem, Universidade Federal de São Paulo, R. Napoleão de Barros, 754 - Vila Clementino, São Paulo, SP, 04024-002, Brazil.""}, {'ForeName': 'Érika de Sá Vieira', 'Initials': 'ÉSV', 'LastName': 'Abuchaim', 'Affiliation': ""Women's Health Nursing Department, Escola Paulista de Enfermagem, Universidade Federal de São Paulo, R. Napoleão de Barros, 754 - Vila Clementino, São Paulo, SP, 04024-002, Brazil.""}, {'ForeName': 'Ana Cristina Freitas de Vilhena', 'Initials': 'ACFV', 'LastName': 'Abrão', 'Affiliation': ""Women's Health Nursing Department, Escola Paulista de Enfermagem, Universidade Federal de São Paulo, R. Napoleão de Barros, 754 - Vila Clementino, São Paulo, SP, 04024-002, Brazil.""}]",Lasers in medical science,['10.1007/s10103-019-02786-5']
691,32401286,Effect of Internet vs Face-to-Face Cognitive Behavior Therapy for Health Anxiety: A Randomized Noninferiority Clinical Trial.,"Importance


Health anxiety is a common and often chronic mental health problem associated with distress, substantial costs, and frequent attendance throughout the health care system. Face-to-face cognitive behavior therapy (CBT) is the criterion standard treatment, but access is limited.
Objective


To test the hypothesis that internet-delivered CBT, which requires relatively little resources, is noninferior to face-to-face CBT in the treatment of health anxiety.
Design, Setting, and Participants


This randomized noninferiority clinical trial with health economic analysis was based at a primary care clinic and included patients with a principal diagnosis of health anxiety who were self-referred or referred from routine care. Recruitment began in December 10, 2014, and the last treatment ended on July 23, 2017. Follow-up data were collected up to 12 months after treatment. Analysis began October 2017 and ended March 2020.
Interventions


Patients were randomized (1:1) to 12 weeks of internet-delivered CBT or to individual face-to-face CBT.
Main Outcomes and Measures


Change in health anxiety symptoms from baseline to week 12. Analyses were conducted from intention-to-treat and per-protocol (completers only) perspectives, using the noninferiority margin of 2.25 points on the Health Anxiety Inventory, which has a theoretical range of 0 to 54.
Results


Overall, 204 patients (mean [SD] age, 39 [12] years; 143 women [70%]) contributed with 2386 data points on the Health Anxiety Inventory over the treatment period. Of 204 patients, 102 (50%) were randomized to internet-delivered CBT, and 102 (50%) were randomized to face-to-face CBT. The 1-sided 95% CI upper limits for the internet-delivered CBT vs face-to-face CBT difference in change were within the noninferiority margin in the intention-to-treat analysis (B = 0.00; upper limit: 1.98; Cohen d = 0.00; upper limit: 0.23) and per-protocol analysis (B = 0.01; upper limit: 2.17; Cohen d = 0.00; upper limit: 0.25). The between-group effect was not moderated by initial symptom level, recruitment path, or patient treatment preference. Therapists spent 10.0 minutes per patient per week in the online treatment vs 45.6 minutes for face-to-face CBT. The net societal cost was lower in the online treatment (treatment period point difference: $3854). There was no significant group difference in the number of adverse events, and no serious adverse event was reported.
Conclusions and Relevance


In this trial, internet-delivered CBT appeared to be noninferior to face-to-face CBT for health anxiety, while incurring lower net societal costs. The online treatment format has potential to increase access to evidence-based treatment for health anxiety.
Trial Registration


ClinicalTrials.gov Identifier: NCT02314065.",2020,The 1-sided 95% CI upper limits for the internet-delivered CBT vs face-to-face CBT difference in change were within the noninferiority margin in the intention-to-treat analysis (B = 0.00; upper limit: 1.98; Cohen d = 0.00; upper limit: 0.23) and per-protocol analysis (B = 0.01; upper limit: 2.17; Cohen d = 0.00; upper limit: 0.25).,"['Of 204 patients, 102 (50%) were randomized to internet-delivered CBT, and 102 (50', '204 patients (mean [SD] age, 39 [12] years; 143 women [70%]) contributed with 2386 data points on the Health Anxiety Inventory over the treatment period', 'primary care clinic and included patients with a principal diagnosis of health anxiety who were self-referred or referred from routine care', 'Health Anxiety']","['Face-to-face cognitive behavior therapy (CBT', 'internet-delivered CBT or to individual face-to-face CBT', 'Internet vs Face-to-Face Cognitive Behavior Therapy']","['initial symptom level, recruitment path, or patient treatment preference', 'health anxiety symptoms', 'net societal cost', '1-sided 95% CI upper limits', 'number of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C3266254', 'cui_str': 'Referred by self'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.102247,The 1-sided 95% CI upper limits for the internet-delivered CBT vs face-to-face CBT difference in change were within the noninferiority margin in the intention-to-treat analysis (B = 0.00; upper limit: 1.98; Cohen d = 0.00; upper limit: 0.23) and per-protocol analysis (B = 0.01; upper limit: 2.17; Cohen d = 0.00; upper limit: 0.25).,"[{'ForeName': 'Erland', 'Initials': 'E', 'LastName': 'Axelsson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Andersson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Brjánn', 'Initials': 'B', 'LastName': 'Ljótsson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Björkander', 'Affiliation': 'Gustavsberg Academic Primary Care Clinic, Gustavsberg, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hedman-Lagerlöf', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hedman-Lagerlöf', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.0940']
692,32402773,The Effect of Cold Vapor and Ice Cube Absorption in the Early Postoperative Period on Sore Throat and Hoarseness Induced by Intubation.,"PURPOSE


This study aimed to determine the effect of cold vapor and ice cube absorption in the early postoperative period on sore throat and hoarseness induced by intubation.
DESIGN


This is a randomized controlled experimental study.
METHODS


Four groups (n = 30) were involved in the study: cold vapor application (group 1), ice cube absorption (group 2), ice cube absorption along with cold vapor application (group 3), and a control group (group 4). The sample consisted of 120 participants. The data were collected using the visual analog scale (VAS) and Stout's hoarseness scale postextubation (zeroth hour) and at the second, sixth, and 24th hours.
FINDINGS


After the interventions, the mean VAS scores for sore throat at the sixth postoperative hour were found to be 1.50 ± 1.71, 1.16 ± 1.08, and 1.30 ± 1.62 in group 1, group 2, and group 3, respectively. The mean VAS score for sore throat of group 4 was found to be 3.70 ± 1.89. The decrease in the VAS score for the sixth postoperative hour was ranked from highest to lowest as follows: ice cube absorption group, ice cube absorption along with cold vapor application group, and cold vapor application group. There was no significant difference between application groups in terms of mean VAS scores; however, it was found that mean VAS scores of all application groups were lower than that of control group, and there was a significant difference between them (P < .05). We found that at the sixth postoperative hour after intervention, 33.3% of group 1, 36.7% of group 2, 30% of group 3, and 46.7% of group 4 had hoarseness. No significant difference was found between groups, in terms of hoarseness scores of patients in the sixth postoperative hour after intervention (P > .05).
CONCLUSIONS


Cold vapor application, ice cube absorption, and ice cube absorption along with cold vapor application were effective in reducing sore throat but were ineffective as treatment for hoarseness.",2020,"No significant difference was found between groups, in terms of hoarseness scores of patients in the sixth postoperative hour after intervention (P > .05).
","['Four groups (n\xa0= 30) were involved in the study', 'Sore Throat and Hoarseness Induced by Intubation', '120 participants', 'sore throat and hoarseness induced by intubation']","['cold vapor and ice cube absorption', 'cold vapor application (group 1), ice cube absorption (group 2), ice cube absorption along with cold vapor application', 'Cold Vapor and Ice Cube Absorption']","['VAS score', 'hoarseness', 'hoarseness scores', 'mean VAS scores', ""visual analog scale (VAS) and Stout's hoarseness scale postextubation (zeroth hour) and at the second, sixth, and 24th hours"", 'mean VAS score']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0597635', 'cui_str': 'Vapor'}, {'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0452470', 'cui_str': 'Stout'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}]",120.0,0.0248688,"No significant difference was found between groups, in terms of hoarseness scores of patients in the sixth postoperative hour after intervention (P > .05).
","[{'ForeName': 'Muazzez', 'Initials': 'M', 'LastName': 'Şahbaz', 'Affiliation': 'Department of Fundamentals of Nursing, Nursing Faculty, Aydın Adnan Menderes University, Aydın, Turkey. Electronic address: muazzez_sahbaz@hotmail.com.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Khorshid', 'Affiliation': 'Department of Fundamentals of Nursing, Nursing Faculty, Ege University, Ä°zmir, Turkey.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.12.007']
693,32402832,Transrectal Natural Orifice Specimen Extraction (NOSE) With Oncological Safety: A Prospective and Randomized Trial.,"BACKGROUND


In the present paper, we introduce our experience with the novel method during laparoscopic anterior resection of upper rectal or sigmoid colon cancer by transrectal natural orifice specimen extraction (NOSE).
METHODS


A prospective randomized controlled trial was performed from June 2016 to May 2019. Patients with upper rectal or sigmoid colon cancer were randomized in a 1:1 ratio to the NOSE group and the non-NOSE group. Preoperative and postoperative clinical variables were analyzed and compared between groups. Postoperative pain was analyzed utilizing a visual analog scale. Postoperative overall survival was analyzed using a Kaplan-Meier curve.
RESULTS


A total of 276 patients were enrolled, of whom 254 were randomly divided into the NOSE group (n = 122) and the conventional laparoscopic group (n = 119). NOSE failed in 22 cases, which were converted to transabdominal specimen extraction. Intention-to-treat analysis was performed, and these 22 cases were included in the NOSE group. The incidence of postoperative complications was significantly lower in the NOSE group (11/122, 9%) than in the non-NOSE group (25/119, 21%). The NOSE group had a longer operation time, less blood loss, and a lower postoperative visual analog scale score than the non-NOSE group. The time for intestinal function recovery (ventilation) and the length of hospital stay were significantly longer in the non-NOSE group. The Kaplan-Meier survival curve showed no statistically significant difference in the disease-free survival rate between the NOSE group and the non-NOSE group.
CONCLUSIONS


The novel NOSE method is safe and feasible to use in patients having colorectal cancer. Compared with traditional laparoscopic surgery, the postoperative complication rates of NOSE surgery were lower with an improved short-term clinical recovery.",2020,"The Kaplan-Meier survival curve showed no statistically significant difference in the disease-free survival rate between the NOSE group and the non-NOSE group.
","['June 2016 to May 2019', 'patients having colorectal cancer', '22 cases were included in the NOSE group', 'Patients with upper rectal or sigmoid colon cancer', 'A total of 276 patients were enrolled, of whom 254']","['conventional laparoscopic group', 'traditional laparoscopic surgery', 'laparoscopic anterior resection of upper rectal or sigmoid colon cancer by transrectal natural orifice specimen extraction (NOSE', 'Transrectal Natural Orifice Specimen Extraction (NOSE', 'NOSE']","['incidence of postoperative complications', 'longer operation time, less blood loss', 'postoperative complication rates of NOSE surgery', 'time for intestinal function recovery (ventilation) and the length of hospital stay', 'disease-free survival rate', 'postoperative visual analog scale score', 'Postoperative overall survival', 'Postoperative pain']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0153436', 'cui_str': 'Malignant tumor of sigmoid colon'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0153436', 'cui_str': 'Malignant tumor of sigmoid colon'}, {'cui': 'C0205518', 'cui_str': 'Transrectal approach'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",276.0,0.0637219,"The Kaplan-Meier survival curve showed no statistically significant difference in the disease-free survival rate between the NOSE group and the non-NOSE group.
","[{'ForeName': 'Zhu-Qing', 'Initials': 'ZQ', 'LastName': 'Zhou', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Kaijing', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Du', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qixin', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Chuan-Gang', 'Initials': 'CG', 'LastName': 'Fu', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China. Electronic address: fugang416@126.com.'}]",The Journal of surgical research,['10.1016/j.jss.2020.03.064']
694,32402931,Long-term outcome of perioperative low cardiac output syndrome in cardiac surgery: 1-year results of a multicenter randomized trial.,"PURPOSE


Perioperative myocardial dysfunction occurs frequently in cardiac surgery, and is a risk factor for morbidity and mortality. Levosimendan has been suggested to reduce mortality of patients with perioperative myocardial dysfunction. However, long-term outcome data on its efficacy in cardiac surgery are lacking.
MATERIALS AND METHODS


Cardiac surgery patients with perioperative myocardial dysfunction were randomized to levosimendan or placebo, in addition to standard inotropic care. One-year mortality data were collected.
RESULTS


We randomized 506 patients (248 to levosimendan 258 to placebo). At 1-year follow-up, 41 patients (16.5%) died in the levosimendan group, while 47 (18.3%) died in the placebo group (absolute risk difference -1.8; 95% CI -8.4 to 4.9; P = .60). Female sex, history of chronic obstructive pulmonary disease, previous myocardial infarction, serum creatinine, hematocrit, mean arterial pressure, and duration of cardiopulmonary bypass were independently associated with 1-year mortality.
CONCLUSIONS


Levosimendan administration does not improve 1-year survival in cardiac surgery patients with perioperative myocardial dysfunction. One-year mortality in these patients is 17%. Six predictive factors for long-term mortality were identified.
STUDY REGISTRATION NUMBER


NCT00994825 (ClinicalTrials.gov).",2020,"At 1-year follow-up, 41 patients (16.5%) died in the levosimendan group, while 47 (18.3%) died in the placebo group (absolute risk difference -1.8; 95% CI -8.4 to 4.9; P = .60).","['Cardiac surgery patients with perioperative myocardial dysfunction', 'cardiac surgery', 'cardiac surgery patients with perioperative myocardial dysfunction', '506 patients (248 to', 'patients with perioperative myocardial dysfunction']","['Levosimendan', 'perioperative low cardiac output syndrome', 'levosimendan', 'levosimendan 258 to placebo', 'levosimendan or placebo']","['Female sex, history of chronic obstructive pulmonary disease, previous myocardial infarction, serum creatinine, hematocrit, mean arterial pressure, and duration of cardiopulmonary bypass', '1-year survival']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340515', 'cui_str': 'Myocardial dysfunction'}]","[{'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0600177', 'cui_str': 'Low cardiac output syndrome'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",506.0,0.403453,"At 1-year follow-up, 41 patients (16.5%) died in the levosimendan group, while 47 (18.3%) died in the placebo group (absolute risk difference -1.8; 95% CI -8.4 to 4.9; P = .60).","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zangrillo', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Vladimir V', 'Initials': 'VV', 'LastName': 'Lomivorotov', 'Affiliation': 'Department of Anesthesiology and Intensive Care, E. Meshalkin National Medical Research Center, Novosibirsk, Russia; Novosibirsk State University, Novosibirsk, Russia.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pisano', 'Affiliation': 'Division of Cardiac Anesthesia and Intensive Care Unit, AORN dei Colli - Monaldi Hospital, Naples, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Calabrò', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Belletti', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Brazzi', 'Affiliation': 'Department of Anesthesia, Intensive Care and Emergency, Città della Salute e della Scienza Hospital, Turin, Italy; Department of Surgical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Evgeny V', 'Initials': 'EV', 'LastName': 'Grigoryev', 'Affiliation': 'Intensive Care Unit, Scientific Research Institute for Complex Issues of Cardiovascular Diseases, Kemerovo, Russia.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Guarracino', 'Affiliation': 'Division of Cardiothoracic Anesthesia and Intensive Care, Department of Anesthesia and Critical Care Medicine, AOU Pisana, Pisa, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Monaco', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Garofalo', 'Affiliation': 'Department of Anesthesia and Intensive Care, AOU Mater Domini Germaneto, Catanzaro, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Crivellari', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Valery V', 'Initials': 'VV', 'LastName': 'Likhvantsev', 'Affiliation': 'Department of Anesthesiology and Intensive Care, First Moscow State Medical University, Moscow, Russia; V. Negovsky Reanimatology Research Institute, Moscow, Russia.'}, {'ForeName': 'Evgeny V', 'Initials': 'EV', 'LastName': 'Fominskiy', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Paternoster', 'Affiliation': 'Department of Anesthesia and Intensive Care, San Carlo Hospital, Potenza, Italy.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Yavorovskiy', 'Affiliation': 'Department of Anesthesiology and Intensive Care, First Moscow State Medical University, Moscow, Russia.'}, {'ForeName': 'Vadim V', 'Initials': 'VV', 'LastName': 'Pasyuga', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Federal Center for Cardiovascular Surgery Astrakhan, Astrakhan, Russia.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Oriani', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Lembo', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Bianchi', 'Affiliation': 'Department of Cardiovascular Anesthesia and Intensive Care, AO Ordine Mauriziano, Turin, Italy.'}, {'ForeName': 'A Mara', 'Initials': 'AM', 'LastName': 'Scandroglio', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Marat N', 'Initials': 'MN', 'LastName': 'Abubakirov', 'Affiliation': 'Department of Anesthesiology and Intensive Care, E. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Di Tomasso', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy. Electronic address: landoni.giovanni@hsr.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of critical care,['10.1016/j.jcrc.2020.04.005']
695,32402953,The effect of swimming program on body composition levels in adolescents with Down syndrome.,"BACKGROUND


Down syndrome has been associated with more than 80 clinical characteristics such as diabetes, cardiovascular problems or obesity.
AIMS


The current study determined the effect of a 36 weeks swimming program on different indicators of body composition in adolescents with Down syndrome.
METHODS AND PROCEDURES OUTCOMES


45 adolescents with Down syndrome were recruited and randomized to two groups (control group vs. exercise group). Adolescents allocated in the control group carried out a recreational swimming program twice a week during 36 weeks meanwhile adolescents allocated in the exercise group did exercise three time a week during 36 weeks. BMI, Waist circumference, waist-to-height ratio, triceps, subscapular, suprailiac and thigh skinfold were measured.
RESULTS


ANCOVA tests were used to evaluate differences between groups in post-test intervention. Repeated measures of ANOVA were performed in order to assess differences in pre-test intervention in each group. t test were carried out to compare the pre-post-intervention differences in physical characteristics and body composition within each group. The exercise group had significant improvements in all variables of body composition (p < 0.05) except in subscapular and thigh skinfold.
CONCLUSIONS AND IMPLICATIONS


The results suggest that a 36 weeks swimming program consisting of 3 sessions of 50 minutes is able to decrease levels of body composition in a sample of adolescents with Down syndrome. The findings indicate that it would be important to generate high intensity sports programs in sports associations in order to obtain positive impact on body composition levels within this population.",2020,"The exercise group had significant improvements in all variables of body composition (p < 0.05) except in subscapular and thigh skinfold.
","['45 adolescents with Down syndrome', 'adolescents with Down syndrome']","['swimming program', 'recreational swimming program']","['body composition levels', 'body composition', 'levels of body composition', 'BMI, Waist circumference, waist-to-height ratio, triceps, subscapular, suprailiac and thigh skinfold', 'subscapular and thigh skinfold']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}]","[{'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1821269', 'cui_str': 'Waist to Height Ratio'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}]",45.0,0.0627267,"The exercise group had significant improvements in all variables of body composition (p < 0.05) except in subscapular and thigh skinfold.
","[{'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Suarez-Villadat', 'Affiliation': 'Department of Physical Activity and Sport Sciences, Alfonso X el Sabio University, Madrid, Spain. Electronic address: bsuarvil@uax.es.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Luna-Oliva', 'Affiliation': 'Department of Physiotherapy, Occupational Therapy, Rehabilitation and Physical Medicine. Rey Juan Carlos University, Madrid, Spain. Electronic address: laura.luna@urjc.es.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Acebes', 'Affiliation': 'Department of Physical Education, Sport and Human Movement, Autonomous University of Madrid, Madrid, Spain. Electronic address: carla.acebes@estudiante.uam.es.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Villagra', 'Affiliation': 'Department of Physical Education, Sport and Human Movement, Autonomous University of Madrid, Madrid, Spain. Electronic address: Ariel.villagra@uam.es.'}]",Research in developmental disabilities,['10.1016/j.ridd.2020.103643']
696,32404116,Effects of active localization and vascular preservation of inferior parathyroid glands in central neck dissection for papillary thyroid carcinoma.,"BACKGROUND


The purpose of present study is to assess the effects of active localization and vascular preservation of inferior parathyroid glands in central neck dissection (CND) for papillary thyroid carcinoma (PTC).
METHODS


A classification of IPGs according to their location and vascular features was developed, and, based on this classification, a CND procedure was designed, and IPGs and their vascular were actively localized and strategically preserved. A total of 197 patients with PTC who underwent a total thyroidectomy and concomitant CND were enrolled. Eighty-nine patients with traditional meticulous fascia dissection were allocated to group A, and 108 patients with active location and vascular preservation of IPGs were allocated to group B. Those with inferior parathyroid glands auto-transplantation in each group were assigned as group At (18) and group Bt (12). Variables including serum intact parathyroid hormone (PTH), total calcium, the incidence of transient, and permanent hypoparathyroidism were studied.
RESULTS


Compared with group A, serum intact PTH (P < 0.001) and total calcium levels (P < 0.05) in group B significantly improved on the first postoperative day, and the incidence of transient hypoparathyroidism significantly dropped in group B (P < 0.001). A total of 170 patients in the two groups had complete follow-up data. The incidence of permanent hypoparathyroidism significantly decreased in group B, from 8.8% to 1.0% (P = 0.017). However, there were no significant differences in all variables between group Bt and group At.
CONCLUSION


Active location and vascular preservation of inferior parathyroid glands effectively protected the function of IPGs in CND for PTC.",2020,"Compared with group A, serum intact PTH (P < 0.001) and total calcium levels (P < 0.05) in group B significantly improved on the first postoperative day, and the incidence of transient hypoparathyroidism significantly dropped in group B (P < 0.001).","['197 patients with PTC who underwent a total thyroidectomy and concomitant CND were enrolled', 'Eighty-nine patients with traditional meticulous fascia dissection', 'central neck dissection for papillary thyroid carcinoma', '170 patients in the two groups had complete follow-up data', '108 patients with active location and vascular preservation of IPGs', 'central neck dissection (CND) for papillary thyroid carcinoma (PTC']","['inferior parathyroid glands auto-transplantation', 'active localization and vascular preservation of inferior parathyroid glands']","['incidence of transient hypoparathyroidism', 'incidence of permanent hypoparathyroidism', 'serum intact PTH', 'total calcium levels', 'serum intact parathyroid hormone (PTH), total calcium, the incidence of transient, and permanent hypoparathyroidism']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238463', 'cui_str': 'Papillary thyroid carcinoma'}, {'cui': 'C0193788', 'cui_str': 'Total thyroidectomy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}]","[{'cui': 'C0447650', 'cui_str': 'Inferior parathyroid gland'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1282979', 'cui_str': 'Transient hypoparathyroidism'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0020626', 'cui_str': 'Hypoparathyroidism'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0040704', 'cui_str': 'Transients'}]",197.0,0.138386,"Compared with group A, serum intact PTH (P < 0.001) and total calcium levels (P < 0.05) in group B significantly improved on the first postoperative day, and the incidence of transient hypoparathyroidism significantly dropped in group B (P < 0.001).","[{'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Hou', 'Affiliation': 'Department of General Surgery, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan Street, Gulou District, Nanjing, 210011, NO, China.'}, {'ForeName': 'Haie', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'The School of Public Health, Nanjing Medical University, Nanjing, 211166, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Yuan', 'Affiliation': 'Department of General Surgery, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan Street, Gulou District, Nanjing, 210011, NO, China.'}, {'ForeName': 'Jianhui', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan Street, Gulou District, Nanjing, 210011, NO, China.'}, {'ForeName': 'Yibing', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, 210011, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Information and Data, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, 210011, China.'}, {'ForeName': 'Zhuyin', 'Initials': 'Z', 'LastName': 'Qian', 'Affiliation': 'Department of General Surgery, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan Street, Gulou District, Nanjing, 210011, NO, China. zhuyin_qian66@163.com.'}]",World journal of surgical oncology,['10.1186/s12957-020-01867-y']
697,32404117,Effects of prostaglandin E 1  nebulization of ventilated lung under 60%O 2  one lung ventilation on patients' oxygenation and oxidative stress: a randomised controlled trial.,"BACKGROUND


High FiO 2  during one-lung ventilation (OLV) can improve oxygenation, but increase the risk of atelectasis and oxidative stress. The aim of this study was to analyze whether Prostaglandin E 1  (PGE 1 ) can improve oxygenation and attenuate oxidative stress during OLV under a lower FiO 2 .
METHOD


Ninety patients selectively undergoing thoracotomy for esophageal cancer were randomly divided into three groups (n = 30/group): Group P (FiO 2  = 0.6, inhaling PGE 1  0.1 μg/kg), Group L (FiO 2  = 0.6) and Group C (FiO 2  = 1.0). The primary outcomes were oxygenation and pulmonary shunt during OLV. Secondary outcomes included haemodynamics, respiratory mechanics and oxidative stress in serum.
RESULTS


Patients in Group P had significantly higher PaO 2  and lower shunt fraction in 30 min of OLV compared with Group L. Compared with Group C, patients in Group P had similar levels of PaO 2 /FiO 2  in 60 min and higher levels of PaO 2 /FiO 2  at 2 h during OLV. The levels of PvO 2  and SvO 2  in Group P and Group L were significantly lower than Group C. Patients in Group P and Group L had significantly higher levels of superoxide dismutase and lower levels of malondialdehyde than Group C. No significant differences were found in SPO 2 , ETCO 2 , PaCO 2 , Paw, HR and MAP among the three groups. The complications in Group C were significantly higher than another two groups.
CONCLUSION


PGE 1  can maintain adequate oxygenation in patients with low FiO 2  (0.6) during OLV. Reducing FiO 2  to 0.6 during OLV can decrease the levels of oxidative stress and complications after OLV.
TRIAL REGISTRATION


chictr.org.cn identifier: ChiCTR1800017100.",2020,"The levels of PvO 2  and SvO 2  in Group P and Group L were significantly lower than Group C. Patients in Group P and Group L had significantly higher levels of superoxide dismutase and lower levels of malondialdehyde than Group C. No significant differences were found in SPO 2 , ETCO 2 , PaCO 2 , Paw, HR and MAP among the three groups.","['Ninety patients selectively undergoing thoracotomy for esophageal cancer', ""ventilated lung under 60%O 2  one lung ventilation on patients' oxygenation and oxidative stress""]","['prostaglandin E', 'Prostaglandin E 1  (PGE 1 ']","['haemodynamics, respiratory mechanics and oxidative stress in serum', 'superoxide dismutase and lower levels of malondialdehyde', 'PaO 2  and lower shunt fraction', 'oxygenation and attenuate oxidative stress', 'SPO 2 , ETCO 2 , PaCO 2 , Paw, HR and MAP', 'levels of PvO 2  and SvO 2', 'levels of oxidative stress and complications', 'oxygenation and pulmonary shunt during OLV']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]","[{'cui': 'C0033559', 'cui_str': 'E series prostaglandin'}, {'cui': 'C0002335', 'cui_str': 'Alprostadil'}]","[{'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]",90.0,0.0867962,"The levels of PvO 2  and SvO 2  in Group P and Group L were significantly lower than Group C. Patients in Group P and Group L had significantly higher levels of superoxide dismutase and lower levels of malondialdehyde than Group C. No significant differences were found in SPO 2 , ETCO 2 , PaCO 2 , Paw, HR and MAP among the three groups.","[{'ForeName': 'Pengyi', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, No. 42 Baiziting, Xuanwu District, Nanjing, 210009, China.'}, {'ForeName': 'Lianbing', 'Initials': 'L', 'LastName': 'Gu', 'Affiliation': 'Department of Anesthesiology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, No. 42 Baiziting, Xuanwu District, Nanjing, 210009, China.'}, {'ForeName': 'Qingming', 'Initials': 'Q', 'LastName': 'Bian', 'Affiliation': 'Department of Anesthesiology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, No. 42 Baiziting, Xuanwu District, Nanjing, 210009, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'Department of Anesthesiology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, No. 42 Baiziting, Xuanwu District, Nanjing, 210009, China.'}, {'ForeName': 'Dian', 'Initials': 'D', 'LastName': 'Jiao', 'Affiliation': 'Department of Anesthesiology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, No. 42 Baiziting, Xuanwu District, Nanjing, 210009, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Renji Clinical School, Shanghai Jiao Tong University School of Medicine, Shanghai, 200000, China.'}, {'ForeName': 'Zeping', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, No. 42 Baiziting, Xuanwu District, Nanjing, 210009, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, No. 42 Baiziting, Xuanwu District, Nanjing, 210009, China. wangljun520@163.com.'}]",Respiratory research,['10.1186/s12931-020-01380-6']
698,32404126,An online solution focused brief therapy for adolescent anxiety during the novel coronavirus disease (COVID-19) pandemic: a structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


This study aims to assess the effectiveness of delivering Solution Focused Brief Therapy (SFBT) through telecommunication with a group of adolescents who present anxiety symptoms during the COVID-19 outbreak. We hypothesize that participants who are randomly assigned to receive 2-4 sessions of Solution Focused Brief Therapy would have better clinical outcomes than participants who are in the waitlist group. We additionally hypothesized that using SFBT can also change participants' depression levels and their coping strategies in dealing with distress during the COVID-19 pandemic.
TRIAL DESIGN


This study employs a randomized delayed crossover open label controlled trial in adolescents who are presenting anxiety symptoms during the COVID-19 outbreak. Participants who meet the enrollment criteria stated below will be invited to participate in this study through telecommunication. Those accepting will be randomly allocated to the intervention group or waitlist group.",2020,"We additionally hypothesized that using SFBT can also change participants' depression levels and their coping strategies in dealing with distress during the COVID-19 pandemic.
","['adolescent anxiety during the novel coronavirus disease (COVID-19) pandemic', 'Participants who meet the enrollment criteria stated below will be invited to participate in this study through telecommunication', 'adolescents who are presenting anxiety symptoms during the COVID-19 outbreak', 'adolescents who present anxiety symptoms during the COVID-19 outbreak']","['delivering Solution Focused Brief Therapy (SFBT', 'SFBT']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039449', 'cui_str': 'Telecommunications'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0012652', 'cui_str': 'Disease outbreak'}]","[{'cui': 'C1276047', 'cui_str': 'Brief solution focused psychotherapy'}]",[],,0.119722,"We additionally hypothesized that using SFBT can also change participants' depression levels and their coping strategies in dealing with distress during the COVID-19 pandemic.
","[{'ForeName': 'Shitao', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Beijing Normal University, Faculty of Psychology, Beijing, China. chenshitao@bnu.edu.cn.'}]",Trials,['10.1186/s13063-020-04355-6']
699,32404723,The Effect of Self-Care Program Based on Modeling and Role Modeling Theory on Body Image Nurturance in Patients With Colorectal Cancer: A Randomized Clinical Trial.,"One of the most critical disorders among patients with colorectal cancer is a change in their body image. This study aimed to examine the effect of a self-care program based on the modeling and role-modeling theory on nurturing body image of patients with colorectal cancer. In 2018, a 2-group randomized clinical trial was conducted in Mashhad, Iran. According to the modeling and role-modeling theory, 27 patients allocated in the experimental group received five 30- to 45-minute sessions at the hospital and 4 sessions of phone counseling within 2 weeks. Twenty-seven patients randomly allocated in the control group received the routine care. Data were collected by demographic and body image scales 3 times with the patients. The mean age of the patients in experimental and control groups was not significantly different (P = .46). The mean scores of the body image at the admission time were 26.8 ± 2.6 in the experimental and 27.9 ± 3.1 in control groups (P = .12). However, the mean scores of body image of the experimental group were 24.3 ± 4.6 at the discharge time and 28.1 ± 2.1 during the follow-up phase. In the control group, the body image scores were 21.0 ± 5.6 at discharge time and 22.9 ± 6.1 during the follow-up phase. Repeated-measures analysis of variance revealed significant differences between the 2 groups (P ≤ .001). Application of the self-care program based on the modeling and role-modeling theory can play a critical role in nurturing the body image of patients with colorectal cancer.",2020,The mean age of the patients in experimental and control groups was not significantly different (P = .46).,"['Patients With Colorectal Cancer', 'patients with colorectal cancer']","['routine care', 'Self-Care Program', 'self-care program']","['mean scores of the body image at the admission time', 'mean scores of body image', 'body image scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",27.0,0.0185153,The mean age of the patients in experimental and control groups was not significantly different (P = .46).,"[{'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Pakzad Khalilabad', 'Affiliation': 'Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhahd, Iran (Ms Pakzad Khalilabad, Dr Aghebati, and Mr Behnam Vashani); and Department of Medical Surgical Nursing (Ms Pakzad Khalilabad and Dr Aghebati), and Pediatric Nursing (Mr Behnam Vashani), School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Aghebati', 'Affiliation': ''}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Behnam Vashani', 'Affiliation': ''}]",Holistic nursing practice,['10.1097/HNP.0000000000000390']
700,32404725,Effects of the Continuous Care Model on the Health-Promoting Lifestyle in Breast Cancer Survivors: A Randomized Clinical Trial.,"Breast cancer is the most frequently diagnosed cancer and the chief cause of cancer-related death among women worldwide, with the incidence increasing exponentially particularly in low- to middle-income countries. The increase in the incidence of breast cancer is partly accounted for by increases in life expectancy due to improvements in public health, but also related to an increase in risk factors for cancer including smoking, excess body weight, decreased physical activity, and changes in reproductive activity. Health-promoting lifestyle is therefore one of the major topics of importance in studying chronic illnesses and cancer. Health promotion interventions, including the use of care models, have a vast contribution to make in terms of timely diagnosis and improved survival. One such care model, which has been designed to increase self-care, adherence, and performance in chronic patients, is the continuous care model (CCM). This study was conducted with the purpose of determining the influence of the CCM on the health-promoting lifestyle of patients with breast cancer during 2017-2018. In this randomized clinical trial, 60 patients with breast cancer were chosen by convenience sampling followed by random allocation into treatment and control groups. Six sessions of group discussion were held for the treatment group according to the CCM and items in the health-promoting lifestyle questionnaire. Data collection tools included a general health questionnaire, a demographic questionnaire, a family support questionnaire, and the Health Promoting Lifestyle Profile (HPLP), which respondents completed before and after the intervention. P values ≤ .05 were considered significant. When comparing the mean score of health-promoting lifestyle in both the control and treatment groups, before and after the intervention, significant increases in every dimension were observed. The average overall health promotion lifestyle was revealed to be significantly elevated from 123.48 to 147.12. However, in the control group the mean scores had slightly increased or were the same in all the dimensions. In addition, the average overall health promotion lifestyle had increased from 119.89 to 121.32. The observed difference in mean scores was not statistically significant. The CCM increased the score of health-promoting lifestyle of patients with breast cancer. Therefore, this caring model can be considered an alternative to improve healthy lifestyles of patients with cancer.",2020,"The increase in the incidence of breast cancer is partly accounted for by increases in life expectancy due to improvements in public health, but also related to an increase in risk factors for cancer including smoking, excess body weight, decreased physical activity, and changes in reproductive activity.","['patients with breast cancer during 2017-2018', 'patients with cancer', 'Breast Cancer Survivors', '60 patients with breast cancer', 'patients with breast cancer']","['Continuous Care Model', 'CCM']","['mean scores', 'score of health-promoting lifestyle', 'average overall health promotion lifestyle', 'every dimension', 'mean score of health-promoting lifestyle']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0065772', 'cui_str': 'MCC protocol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",60.0,0.0150827,"The increase in the incidence of breast cancer is partly accounted for by increases in life expectancy due to improvements in public health, but also related to an increase in risk factors for cancer including smoking, excess body weight, decreased physical activity, and changes in reproductive activity.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Moghaddam Tabrizi', 'Affiliation': 'Nursing and Midwifery School, Reproductive Health Research Center, Urmia University of Medical Sciences, Urmia, Iran (Dr Moghaddam Tabrizi) and Nursing and Midwifery School, Urmia University of Medical Sciences, Urmia, Iran (Ms Rajabzadeh and Dr Eghtedar).'}, {'ForeName': 'Hanieh', 'Initials': 'H', 'LastName': 'Rajabzadeh', 'Affiliation': ''}, {'ForeName': 'Samereh', 'Initials': 'S', 'LastName': 'Eghtedar', 'Affiliation': ''}]",Holistic nursing practice,['10.1097/HNP.0000000000000392']
701,32404742,Bovine Lactoferrin Supplementation does not Disrupt Microbiota Development in Preterm Infants Receiving Probiotics.,"OBJECTIVE


To assess whether bovine lactoferrin supplementation disrupts intestinal microbiota development in preterm infants less than 31 weeks gestational age receiving prophylactic probiotic administration.
METHODS


Subjects were recruited from the LACUNA trial (ISRCTN66482337), designed to assess bovine lactoferrin safety. These subjects were randomized to daily receive either probiotic supplements or probiotics supplemented with 100 mg bovine lactoferrin mixed with their feeds (human milk or formula). Stools were collected weekly from enrolled infants for one month and the microbiota characterized using V6-16S rRNA gene amplicon profiling.
RESULTS


Infants microbiomes did not increase in alpha diversity over time in both feeding interventions. Infants receiving bovine lactoferrin supplementation had overall higher species richness as compared to those not receiving these supplements and lactoferrin supplementation had differing effects on infant microbiota species richness depending on the infant's gestational age. Principal co-ordinate analysis revealed that the infant microbiotas did not separate by intervention group, gestational age bracket at birth or sampling time and the main factor dictating sample clustering was infant identity. There were very few detectable differences in taxa relative abundance or functional gene content between the microbiotas in the two study groups.
CONCLUSIONS


Bovine lactoferrin supplementation has minimal impact on microbiota composition/function in preterm infants receiving probiotics and therefore is unlikely to disrupt microbiota development.",2020,"There were very few detectable differences in taxa relative abundance or functional gene content between the microbiotas in the two study groups.
","['preterm infants receiving probiotics', 'Preterm Infants Receiving Probiotics', 'preterm infants less than 31 weeks gestational age receiving prophylactic probiotic administration', 'Subjects']","['bovine lactoferrin supplementation', 'Bovine lactoferrin supplementation', 'lactoferrin supplementation', 'Bovine Lactoferrin Supplementation', 'probiotic supplements or probiotics supplemented with 100\u200amg bovine lactoferrin mixed with their feeds (human milk or formula']","['intestinal microbiota development', 'infant microbiota species richness', 'bovine lactoferrin safety', 'alpha diversity']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C1440867', 'cui_str': 'Bovine lactoferrin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0026140', 'cui_str': 'Breast milk'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C1440867', 'cui_str': 'Bovine lactoferrin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]",,0.0920702,"There were very few detectable differences in taxa relative abundance or functional gene content between the microbiotas in the two study groups.
","[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Grzywacz', 'Affiliation': 'Ottawa Institute of Systems Biology Department of Biochemistry, Microbiology and Immunology University of Ottawa.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Butcher', 'Affiliation': 'Ottawa Institute of Systems Biology Department of Biochemistry, Microbiology and Immunology University of Ottawa.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Ottawa Institute of Systems Biology Department of Biochemistry, Microbiology and Immunology University of Ottawa.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Barrington', 'Affiliation': 'CHU Sainte Justine.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Mohamed', 'Affiliation': 'CHU Sainte Justine.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Stintzi', 'Affiliation': 'Ottawa Institute of Systems Biology Department of Biochemistry, Microbiology and Immunology University of Ottawa.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002734']
702,32404782,"Immunogenicity and Safety of an MF59-adjuvanted Quadrivalent Seasonal Influenza Vaccine in Young Children at High Risk of Influenza-associated Complications: A Phase III, Randomized, Observer-blind, Multicenter Clinical Trial.","BACKGROUND


Vaccination against seasonal influenza is recommended for all children with a history of medical conditions placing them at increased risk of influenza-associated complications. The immunogenicity and efficacy of conventional influenza vaccines among young children are suboptimal; one strategy to enhance these is adjuvantation. We present immunogenicity and safety data for an MF59-adjuvanted quadrivalent influenza vaccine (aIIV4) in healthy children and those at a high risk of influenza-associated complications, based on the results of a recently completed phase III study.
METHODS


Children 6 months to 5 years of age (N = 10,644) were enrolled. The study was conducted across northern hemisphere seasons 2013-2014 and 2014-2015. Subjects received either aIIV4 or a nonadjuvanted comparator influenza vaccine. Antibody responses were assessed by hemagglutination inhibition assay against vaccine and heterologous strains. Long-term antibody persistence was assessed (ClinicalTrials.gov: NCT01964989).
RESULTS


aIIV4 induced significantly higher antibody titers than nonadjuvanted vaccine in high-risk subjects. aIIV4 antibody responses were of similar magnitude in high-risk and healthy subjects. Incidence of solicited local and systemic adverse events (AEs) was slightly higher in aIIV4 than nonadjuvanted vaccinees, in both the healthy and high-risk groups. Incidence of unsolicited AEs, serious AEs and AEs of special interest were similar for adjuvanted and nonadjuvanted vaccinees in the healthy and high-risk groups.
CONCLUSION


aIIV4 was more immunogenic than nonadjuvanted vaccine in both the healthy and high-risk study groups. The reactogenicity and safety profiles of aIIV4 and the nonadjuvanted vaccine were acceptable and similar in 6-month- to 5-year-old high-risk and healthy children.",2020,"Incidence of unsolicited AEs, serious AEs and AEs of special interest were similar for adjuvanted and nonadjuvanted vaccinees in the healthy and high-risk groups.
","['young children', 'Children 6 months to 5 years of age (N = 10,644) were enrolled', 'healthy children and those at a high risk of influenza-associated complications', 'northern hemisphere seasons 2013-2014 and 2014-2015', 'Young Children at High Risk of Influenza-associated Complications']","['MF59-adjuvanted Quadrivalent Seasonal Influenza Vaccine', 'MF59-adjuvanted quadrivalent influenza vaccine (aIIV4', 'conventional influenza vaccines', 'nonadjuvanted vaccine', 'aIIV4 or a nonadjuvanted comparator influenza vaccine']","['Antibody responses', 'immunogenicity and efficacy', 'antibody titers', 'Incidence of unsolicited AEs, serious AEs and AEs of special interest', 'Immunogenicity and Safety', 'Incidence of solicited local and systemic adverse events (AEs']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0289787', 'cui_str': 'MF59 oil emulsion'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]",10644.0,0.0497908,"Incidence of unsolicited AEs, serious AEs and AEs of special interest were similar for adjuvanted and nonadjuvanted vaccinees in the healthy and high-risk groups.
","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Esposito', 'Affiliation': 'From the Pediatric Clinic, Department of Surgical and Biomedical Sciences, Università degli Studi di Perugia, Perugia, Italy.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Fling', 'Affiliation': 'Department of Pediatrics, Health Science Center, University of North Texas, Fort Worth, TX.'}, {'ForeName': 'Kulkanya', 'Initials': 'K', 'LastName': 'Chokephaibulkit', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'de Bruijn', 'Affiliation': 'Seqirus Netherlands B.V., Amsterdam, The Netherlands.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Oberye', 'Affiliation': 'Seqirus Netherlands B.V., Amsterdam, The Netherlands.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Seqirus USA Inc., Cambridge, MA.'}, {'ForeName': 'Jeanique', 'Initials': 'J', 'LastName': 'Vossen', 'Affiliation': 'Seqirus Netherlands B.V., Amsterdam, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Heijnen', 'Affiliation': 'Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Smolenov', 'Affiliation': 'Seqirus USA Inc., Cambridge, MA.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002727']
703,32406162,Efficacy of microneedling plus topical 4% tranexamic acid solution vs 4% hydroquinone in the treatment of melasma: A single-blind randomized clinical trial.,"BACKGROUND


There are various treatment modalities for melasma, but none of them are effective on dermal component of melasma.
AIMS


In this study, we decided to evaluate the efficacy of microneedling plus tranexamic acid in comparison with 4% hydroquinone in the treatment of melasma.
METHODS


This is a single-blind randomized clinical trial on 70 participants with 14% dropout, and therefore, 60 patients with melasma completed the study. Patients were randomized based on simple randomization in 2 groups of A (microneedling plus topical 4% tranexamic acid, monthly) and B (topical 4% hydroquinone, nightly). Evaluation of mean MASI score, patient and physician assessments was performed at 4th, 8th and12th weeks of the treatment. Statistical analysis was performed by paired t test, chi-square test and Fisher's exact test, respectively.
RESULTS


Sixty women (30 patients in each group) were completed the study. Mean MASI score in group A was significantly lower at the end of the treatment (6.84 ± 4.31) than at the baseline (12.89 ± 5.16) (P < .01). Mean MASI score in group B was significantly lower at the end of the treatment (7.16 ± 4.38) than at the baseline (13.56 ± 4.88) (P < .01). There was no statistical difference between 2 groups regarding MASI score, physician and patient assessments during the treatment. Percentage of patient satisfaction was significantly higher than physician satisfaction in both treatment groups (P < .01).
CONCLUSION


In our study, the combination of microneedling with tranexamic acid did not differ from 4% hydroquinone in the treatment of melasma.",2020,"Percentage of patient satisfaction was significantly higher than physician satisfaction in both treatment groups (P < .01).
","['Sixty women (30 patients in each group) were completed the study', 'melasma', '70 participants with 14% dropout, and therefore, 60 patients with melasma completed the study']","['hydroquinone', 'microneedling plus topical 4% tranexamic acid solution vs 4% hydroquinone', 'A (microneedling plus topical 4% tranexamic acid, monthly) and B (topical 4% hydroquinone, nightly', 'microneedling plus tranexamic acid', 'tranexamic acid']","['Percentage of patient satisfaction', 'physician satisfaction', 'MASI score, physician and patient assessments', 'mean MASI score, patient and physician assessments', 'Mean MASI score']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}]","[{'cui': 'C0020306', 'cui_str': 'hydroquinone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031830', 'cui_str': 'Physician Patient Relations'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",70.0,0.118763,"Percentage of patient satisfaction was significantly higher than physician satisfaction in both treatment groups (P < .01).
","[{'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Shamsi Meymandi', 'Affiliation': 'Pathology and Stem Cell Research Center, Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Mozayyeni', 'Affiliation': 'Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Manzumeh', 'Initials': 'M', 'LastName': 'Shamsi Meymandi', 'Affiliation': 'Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mahin', 'Initials': 'M', 'LastName': 'Aflatoonian', 'Affiliation': 'Pathology and Stem Cell Research Center, Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13392']
704,32406808,Wheelchair backs that support the spinal curves: Assessing postural and functional changes.,"Objective:  To compare outcomes using a wheelchair back designed to support the natural seated spinal curves versus an upholstered back that promotes posterior pelvic tilt and thoracolumbar kyphosis. Design:  Cross-over intervention. Setting:  Two free-standing spinal cord injury (SCI) model system hospitals. Participants:  Fifty adults with motor complete SCI C6-T4, between the ages of 18-60 years who use a manual wheelchair for mobility were recruited from a convenience sample. Intervention:  Each participant's wheelchair back support was removed and replaced by an upholstered back and a solid back in randomized order. Postural and functional outcomes, pain, and satisfaction were evaluated using each back. Outcome measures:  Seated postural measurements included pelvic angle, spinal angle of kyphosis and linear measurement of spine. Functional outcomes included vertical forward reach, one stroke push, timed forward wheeling, ramp ascent and descent. Numerical pain rating and a satisfaction survey provided input pertaining to both backs. Results:  The solid back demonstrated significance in seated postural measurements. Participants using the solid back trended to higher scores in functional outcome measures including vertical forward reach, one stroke push and timed ramp ascent. Participants reported increased satisfaction with comfort and stability with the solid back. Conclusions:  This pilot study demonstrated that a wheelchair back, which supports the seated spinal curves improves upright posture, functional reach, and wheelchair propulsion skills. Further research is necessary to demonstrate statistical findings as well as to assess back height and lateral support.",2020,"Participants using the solid back trended to higher scores in functional outcome measures including vertical forward reach, one stroke push and timed ramp ascent.","['Participants:  Fifty adults with motor complete SCI C6-T4, between the ages of 18-60 years who use a manual wheelchair for mobility were recruited from a convenience sample']",['wheelchair back designed to support the natural seated spinal curves versus an upholstered back that promotes posterior pelvic tilt and thoracolumbar kyphosis'],"['Outcome measures:  Seated postural measurements included pelvic angle, spinal angle of kyphosis and linear measurement of spine', 'upright posture, functional reach, and wheelchair propulsion skills', 'Numerical pain rating', 'vertical forward reach, one stroke push, timed forward wheeling, ramp ascent and descent', 'Postural and functional outcomes, pain, and satisfaction', 'satisfaction with comfort and stability with the solid back', 'vertical forward reach, one stroke push and timed ramp ascent']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0184423', 'cui_str': 'Manual wheelchair'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C1629036', 'cui_str': 'Pelvic declination'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}]","[{'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C1321055', 'cui_str': 'Functional reach'}, {'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034646', 'cui_str': 'Ramp'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205208', 'cui_str': 'Solid'}]",50.0,0.0664581,"Participants using the solid back trended to higher scores in functional outcome measures including vertical forward reach, one stroke push and timed ramp ascent.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Presperin Pedersen', 'Affiliation': 'Center for Rehabilitation Outcomes Research, Shirley Ryan AbilityLab, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'Craig Hospital, Denver, Colorado, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Dahlin', 'Affiliation': 'Craig Hospital, Denver, Colorado, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Henry', 'Affiliation': 'Center for Rehabilitation Outcomes Research, Shirley Ryan AbilityLab, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Janell', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'Craig Hospital, Denver, Colorado, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'McKenzie', 'Affiliation': 'Center for Rehabilitation Outcomes Research, Shirley Ryan AbilityLab, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Sevigny', 'Affiliation': 'Craig Hospital, Denver, Colorado, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Yingling', 'Affiliation': 'Center for Rehabilitation Outcomes Research, Shirley Ryan AbilityLab, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}]",The journal of spinal cord medicine,['10.1080/10790268.2020.1760530']
705,32406858,Web-Based Self-Management for Patients With Lymphoma: Assessment of the Reach of Intervention of a Randomized Controlled Trial.,"BACKGROUND


Randomized controlled trials (RCTs) often provide accurate estimates of the internal validity of an intervention but lack information on external validity (generalizability). We conducted an RCT on the effectiveness of a self-management intervention among patients with lymphoma in a population-based setting.
OBJECTIVE


The objectives of the current study were to describe the proportion of RCT participants compared to all patients invited to participate, and compare sociodemographic and clinical characteristics of RCT participants with all respondents, all patients invited to participate, and all patients selected from the Netherlands Cancer Registry (NCR) to determine the reach of the intervention. An additional objective was to assess differences on RCT outcome variables between RCT and paper respondents.
METHODS


Patients with lymphoma or chronic lymphocytic leukemia ≥18 years old at diagnosis from 13 hospitals in the Netherlands were selected from the population-based NCR, which routinely collects data on sociodemographic and clinical characteristics. Eligible patients were invited to participate in an RCT and complete a questionnaire. Web-based completion determined RCT enrollment, whereas paper respondents were followed observationally.
RESULTS


A total of 1193 patients were selected from the NCR, 892 (74.77%) of whom were invited to participate in the trial by their hematologist after verifying eligibility. Among those invited, 25.4% (227/892) completed the web-based questionnaire and were enrolled in the RCT. The RCT participants were younger and there was a higher proportion of men than nonparticipants (P<.001). In addition, 25.7% (229/892) of those invited opted to participate in the paper-based observational follow-up study. Compared with paper respondents, RCT participants were younger (P<.001), with a higher proportion of men (P=.002), and had higher education levels (P=.02). RCT participants more often wanted to receive all available information on their disease (P<.001), whereas paper respondents reported higher levels of emotional distress (P=.009).
CONCLUSIONS


From a population-based sample of eligible patients, the participation rate in the RCT was approximately 25%. RCT participants may not be representative of the target population because of different sociodemographic and clinical characteristics. Since RCT participants represent a minority of the target population, RCT results should be interpreted with caution as patients in the RCT may be those least in need of a self-management intervention.
TRIAL REGISTRATION


Netherlands Trial Register NTR5953; https://www.trialregister.nl/trial/5790.",2020,The RCT participants were younger and there was a higher proportion of men than nonparticipants (P<.001).,"['Patients With Lymphoma', 'Patients with lymphoma or chronic lymphocytic leukemia ≥18 years old at diagnosis from 13 hospitals in the Netherlands were selected from the population-based NCR, which routinely collects data on sociodemographic and clinical characteristics', 'A total of 1193 patients were selected from the NCR, 892 (74.77%) of whom were invited to participate in the trial by their hematologist after verifying eligibility', 'Among those invited, 25.4% (227/892) completed the web-based questionnaire and were enrolled in the RCT', 'From a population-based sample of eligible patients', 'RCT participants with all respondents, all patients invited to participate, and all patients selected from the Netherlands Cancer Registry (NCR) to determine the reach of the intervention', 'patients with lymphoma in a population-based setting', 'Eligible patients were invited to participate in an RCT and complete a questionnaire']","['RCT', 'NTR5953', 'self-management intervention']","['higher education levels', 'emotional distress', 'participation rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0424933', 'cui_str': 'Higher education'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}]",1193.0,0.125336,The RCT participants were younger and there was a higher proportion of men than nonparticipants (P<.001).,"[{'ForeName': 'Lindy P J', 'Initials': 'LPJ', 'LastName': 'Arts', 'Affiliation': 'Netherlands Comprehensive Cancer Organisation, Utrecht, Netherlands.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Oerlemans', 'Affiliation': 'Netherlands Comprehensive Cancer Organisation, Utrecht, Netherlands.'}, {'ForeName': 'Eduardus F M', 'Initials': 'EFM', 'LastName': 'Posthuma', 'Affiliation': 'Department of Internal Medicine, Reinier de Graaf Hospital, Delft, Netherlands.'}, {'ForeName': 'Djamila E', 'Initials': 'DE', 'LastName': 'Issa', 'Affiliation': ""Department of Internal Medicine, Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands.""}, {'ForeName': 'Margriet', 'Initials': 'M', 'LastName': 'Oosterveld', 'Affiliation': 'Department of Internal Medicine, Canisius-Wilhelmina Hospital, Nijmegen, Netherlands.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'van der Griend', 'Affiliation': 'Department of Internal Medicine, Diakonessenhuis, Utrecht/Zeist, Netherlands.'}, {'ForeName': 'Marten R', 'Initials': 'MR', 'LastName': 'Nijziel', 'Affiliation': 'Department of Internal Medicine, Catharina Hospital, Eindhoven, Netherlands.'}, {'ForeName': 'Lonneke V', 'Initials': 'LV', 'LastName': 'van de Poll-Franse', 'Affiliation': 'Netherlands Comprehensive Cancer Organisation, Utrecht, Netherlands.'}]",Journal of medical Internet research,['10.2196/17018']
706,32406864,"Gratitude at Work: Prospective Cohort Study of a Web-Based, Single-Exposure Well-Being Intervention for Health Care Workers.","BACKGROUND


Emotional exhaustion (EE) in health care workers is common and consequentially linked to lower quality of care. Effective interventions to address EE are urgently needed.
OBJECTIVE


This randomized single-exposure trial examined the efficacy of a gratitude letter-writing intervention for improving health care workers' well-being.
METHODS


A total of 1575 health care workers were randomly assigned to one of two gratitude letter-writing prompts (self- vs other focused) to assess differential efficacy. Assessments of EE, subjective happiness, work-life balance, and tool engagement were collected at baseline and 1-week post intervention. Participants received their EE score at baseline and quartile benchmarking scores. Paired-samples t tests, independent t tests, and correlations explored the efficacy of the intervention. Linguistic Inquiry and Word Count software assessed the linguistic content of the gratitude letters and associations with well-being.
RESULTS


Participants in both conditions showed significant improvements in EE, happiness, and work-life balance between the intervention and 1-week follow-up (P<.001). The self-focused (vs other) instruction conditions did not differentially predict improvement in any of the measures (P=.91). Tool engagement was high, and participants reporting higher motivation to improve their EE had higher EE at baseline (P<.001) and were more likely to improve EE a week later (P=.03). Linguistic analyses revealed that participants high on EE at baseline used more negative emotion words in their letters (P=.005). Reduction in EE at the 1-week follow-up was predicted at the level of a trend by using fewer first-person (P=.06) and positive emotion words (P=.09). No baseline differences were found between those who completed the follow-up assessment and those who did not (Ps>.05).
CONCLUSIONS


This single-exposure gratitude letter-writing intervention appears to be a promising low-cost, brief, and meaningful tool to improve the well-being of health care workers.",2020,"No baseline differences were found between those who completed the follow-up assessment and those who did not (Ps>.05).
","['Health Care Workers', '1575 health care workers', 'health care workers']","['gratitude letter-writing intervention', 'Single-Exposure Well-Being Intervention', 'gratitude letter-writing prompts (self- vs other focused']","['Assessments of EE, subjective happiness, work-life balance, and tool engagement', 'negative emotion words', 'EE, happiness, and work-life balance']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C4277700', 'cui_str': 'Work-Life Balance'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}]",,0.0319504,"No baseline differences were found between those who completed the follow-up assessment and those who did not (Ps>.05).
","[{'ForeName': 'Kathryn C', 'Initials': 'KC', 'LastName': 'Adair', 'Affiliation': 'Duke Center for Healthcare Safety and Quality, Duke University Health System, Durham, NC, United States.'}, {'ForeName': 'Larissa G', 'Initials': 'LG', 'LastName': 'Rodriguez-Homs', 'Affiliation': 'Duke University School of Medicine, Durham, NC, United States.'}, {'ForeName': 'Sabran', 'Initials': 'S', 'LastName': 'Masoud', 'Affiliation': 'Duke University School of Medicine, Durham, NC, United States.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Mosca', 'Affiliation': 'Duke Network Services Duke University Health System, Duke University Health System, Durham, NC, United States.'}, {'ForeName': 'J Bryan', 'Initials': 'JB', 'LastName': 'Sexton', 'Affiliation': 'Duke Center for Healthcare Safety and Quality, Duke University Health System, Durham, NC, United States.'}]",Journal of medical Internet research,['10.2196/15562']
707,32202318,Three-year observation of children 12 to 35 months old with untreated intermittent exotropia.,"PURPOSE


To describe the clinical course of untreated intermittent exotropia (IXT) in children 12-35 months of age followed for 3 years.
METHODS


We enrolled 97 children 12-35 months of age with previously untreated IXT who had been randomly assigned to the observation arm of a randomised trial of short-term occlusion versus observation. Participants were observed unless deterioration criteria were met at a follow-up visit occurring at 3 months, 6 months, and 6-month intervals thereafter for 3 years. The primary outcome was deterioration of the IXT by 3 years, defined as (1) a constant exotropia ≥10 prism dioptres (∆) at distance and near (i.e., motor deterioration) or (2) treatment prescribed despite not having met motor deterioration. The primary analysis used the Kaplan-Meier method to determine the cumulative proportion of participants meeting deterioration by three years and 95% confidence interval (CI).
RESULTS


The cumulative probability of deterioration by 3 years was 28% (95% CI = 20%-39%). Of the 24 participants meeting the primary outcome of deterioration, seven met motor deterioration and 17 were prescribed treatment without meeting motor deterioration. The cumulative probability of motor deterioration by 3 years was 10% (95% CI = 5%-19%).
CONCLUSIONS


Given the modest rate of motor deterioration over three years, watchful waiting may be a reasonable management approach in 12- to 35-month-old children with IXT. To confirm this recommendation would require a long-term randomised trial of immediate treatment versus observation followed by deferred treatment if needed.",2020,"The cumulative probability of motor deterioration by 3 years was 10% (95% CI = 5%-19%).
","['24 participants meeting the primary outcome of deterioration, seven met motor deterioration and 17 were prescribed treatment without meeting motor deterioration', '97 children 12-35\xa0months of age with previously untreated IXT who had been randomly assigned to the observation arm of a randomised trial of', 'children 12 to 35 months old with untreated intermittent exotropia', 'children 12-35\xa0months of age followed for 3\xa0years']","['short-term occlusion versus observation', 'untreated intermittent exotropia (IXT']","['deterioration of the IXT by 3\xa0years, defined as (1) a constant exotropia ≥10 prism dioptres (∆) at distance and near (i.e., motor deterioration) or (2) treatment prescribed despite not having met motor deterioration', 'cumulative probability of deterioration', 'cumulative probability of motor deterioration', 'cumulative proportion of participants meeting deterioration']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0423062', 'cui_str': 'Intermittent exotropia (disorder)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0423062', 'cui_str': 'Intermittent exotropia (disorder)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0015310', 'cui_str': 'Strabismus, Divergent'}, {'cui': 'C0439487', 'cui_str': 'prism diopters'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}]",97.0,0.138407,"The cumulative probability of motor deterioration by 3 years was 10% (95% CI = 5%-19%).
","[{'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Cotter', 'Affiliation': 'Southern California College of Optometry at Marshall B Ketchum University, Fullerton, California, USA.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Mohney', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Chandler', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Holmes', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Wallace', 'Affiliation': 'Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'B Michele', 'Initials': 'BM', 'LastName': 'Melia', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Raymond T', 'Initials': 'RT', 'LastName': 'Kraker', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Rosanne', 'Initials': 'R', 'LastName': 'Superstein', 'Affiliation': 'Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Crouch', 'Affiliation': 'Virginia Pediatric Eye Center, Virginia Beach, Virginia, USA.'}, {'ForeName': 'Evelyn A', 'Initials': 'EA', 'LastName': 'Paysse', 'Affiliation': ""Texas Children's Hospital, Houston, Texas, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists),['10.1111/opo.12668']
708,32402585,Body weight of individuals with obesity decreases after a 6-month high pasta or low pasta Mediterranean diet weight-loss intervention.,"BACKGROUND & AIMS


The effect of pasta consumption within a low-energy Mediterranean diet on body weight regulation has been scarcely explored. This paper investigates the effect of two Mediterranean diets, which differed for lower or higher pasta intake, on body weight change in individuals with obesity.
METHODS & RESULTS


Forty-nine volunteers finished a quasi-experimental 6-month two-parallel group dietary intervention. Participants were assigned to a low-energy high pasta (HP) or to a low-energy low Pasta (LP) group on the basis of their pasta intake (HP ≥ 5 or LP ≤ 3 times/week). Anthropometrics, blood pressure and heart rate were measured every month. Weight maintenance was checked at month 12. Body composition (bioelectrical impedance analysis, BIA), food intake (24-h recall plus a 7-day carbohydrate record) and the perceived quality of life (36-item short-form health survey, SF-36) were assessed at baseline, 3 and 6 months. Blood samples were collected at baseline and month 6 to assess glucose and lipid metabolism. After 6-month intervention, body weight reduction was -10 ± 8% and -7 ± 4% in HP and LP diet, respectively, and it remained similar at month 12. Both dietary interventions improved anthropometric parameters, body composition, glucose and lipid metabolism, but no significant differences were observed between treatment groups. No differences were observed for blood pressure and heart rate between treatments and among times. HP diet significantly improved perception of quality of life for the physical component.
CONCLUSIONS


Independent of pasta consumption frequency, low-energy Mediterranean diets were successful in improving anthropometrics, physiological parameters and dietary habits after a 6-month weight-loss intervention. This trial was registered at clinicaltrials.gov as NCT03341650.",2020,"Both dietary interventions improved anthropometric parameters, body composition, glucose and lipid metabolism, but no significant differences were observed between treatment groups.","['Forty-nine volunteers finished a quasi-experimental 6-month two-parallel group dietary intervention', 'individuals with obesity decreases after a 6-month high pasta or low pasta Mediterranean diet weight-loss intervention', 'individuals with obesity']","['low-energy high pasta (HP) or to a low-energy low Pasta (LP', 'HP diet', 'Mediterranean diets']","['perception of quality of life', 'Weight maintenance', 'blood pressure and heart rate', 'anthropometrics, physiological parameters and dietary habits', 'glucose and lipid metabolism', 'Blood samples', 'Body weight', 'anthropometric parameters, body composition, glucose and lipid metabolism', 'Anthropometrics, blood pressure and heart rate', 'Body composition (bioelectrical impedance analysis, BIA), food intake (24-h recall plus a 7-day carbohydrate record) and the perceived quality of life (36-item short-form health survey, SF-36', 'body weight reduction']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0452694', 'cui_str': 'Pasta'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0452694', 'cui_str': 'Pasta'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0162536', 'cui_str': 'Biolectric Impedance'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",49.0,0.0258637,"Both dietary interventions improved anthropometric parameters, body composition, glucose and lipid metabolism, but no significant differences were observed between treatment groups.","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Rosi', 'Affiliation': 'Department of Food & Drugs, University of Parma, Parma, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Tesan', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Annalaura', 'Initials': 'A', 'LastName': 'Cremonini', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Biasini', 'Affiliation': 'Department of Food & Drugs, University of Parma, Parma, Italy.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Bicchieri', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Cossu', 'Affiliation': 'Department of Food & Drugs, University of Parma, Parma, Italy.'}, {'ForeName': 'Furio', 'Initials': 'F', 'LastName': 'Brighenti', 'Affiliation': 'Department of Food & Drugs, University of Parma, Parma, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': ""Dall'Aglio"", 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Scazzina', 'Affiliation': 'Department of Food & Drugs, University of Parma, Parma, Italy. Electronic address: francesca.scazzina@unipr.it.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.02.013']
709,32402604,Group mindfulness-based therapy for persecutory delusions: A pilot randomised controlled trial.,,2020,,['persecutory delusions'],[],[],"[{'cui': 'C0349398', 'cui_str': 'Paranoid delusion'}]",[],[],,0.125109,,"[{'ForeName': 'Lyn', 'Initials': 'L', 'LastName': 'Ellett', 'Affiliation': 'Department of Psychology, Royal Holloway, University of London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Eryna', 'Initials': 'E', 'LastName': 'Tarant', 'Affiliation': 'Surrey and Borders Partnership NHS Foundation Trust, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Kouimtsidis', 'Affiliation': 'Surrey and Borders Partnership NHS Foundation Trust, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kingston', 'Affiliation': 'Department of Psychology, Royal Holloway, University of London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Vivarelli', 'Affiliation': 'Surrey and Borders Partnership NHS Foundation Trust, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Jeewaka', 'Initials': 'J', 'LastName': 'Mendis', 'Affiliation': 'University of Surrey, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Chadwick', 'Affiliation': 'Department of Psychology, University of Bath, United Kingdom of Great Britain and Northern Ireland. Electronic address: pdjc20@bath.ac.uk.'}]",Schizophrenia research,['10.1016/j.schres.2020.04.023']
710,32402609,Feasibility and efficacy of remotely supervised cranial electrical stimulation for pain in older adults with knee osteoarthritis: A randomized controlled pilot study.,"Cranial electrical stimulation (CES) is a noninvasive brain stimulation technique that has been shown to improve pain. However, few studies have investigated the potential benefits associated with remotely supervised CES in older adults with knee osteoarthritis (OA). The aim of this study was to examine the feasibility and preliminary efficacy of remotely supervised CES via secure videoconferencing software on clinical pain severity, experimental pain sensitivity, and pain-related cortical response in older adults with knee OA. Thirty participants with symptomatic knee OA pain were randomly assigned to receive 10 daily sessions (60 min each) of remotely supervised CES (n = 15) or sham CES (n = 15) over two weeks. We measured clinical pain severity via a Numeric Rating Scale, experimental pain sensitivity (e.g., heat pain sensitivity, pressure pain sensitivity, and conditioned pain modulation) using quantitative sensory testing, and pain-related cortical response via functional near-infrared spectroscopy imaging. We also measured participant satisfaction with treatment using the Client Satisfaction Questionnaire. Active CES significantly reduced scores on the Numeric Rating Scale and increased heat pain threshold, pressure pain thresholds, and conditioned pain modulation. We also found significant changes in pain-related cortical hemodynamic activity after CES. Participants tolerated CES well without serious adverse effects and were satisfied with the treatment. Our findings demonstrate promising clinical efficacy of remotely supervised CES for older adults with knee OA.",2020,"Active CES significantly reduced scores on the Numeric Rating Scale and increased heat pain threshold, pressure pain thresholds, and conditioned pain modulation.","['older adults with knee osteoarthritis (OA', 'older adults with knee OA', 'older adults with knee osteoarthritis', 'Thirty participants with symptomatic knee OA pain']","['Cranial electrical stimulation (CES', 'Active CES', 'remotely supervised CES (n\xa0=\xa015) or sham CES', 'remotely supervised CES via secure videoconferencing software', 'remotely supervised CES', 'remotely supervised cranial electrical stimulation']","['clinical pain severity, experimental pain sensitivity, and pain-related cortical response', 'pain-related cortical hemodynamic activity', 'Numeric Rating Scale and increased heat pain threshold, pressure pain thresholds, and conditioned pain modulation', 'clinical pain severity via a Numeric Rating Scale, experimental pain sensitivity (e.g., heat pain sensitivity, pressure pain sensitivity, and conditioned pain modulation) using quantitative sensory testing, and pain-related cortical response via functional near-infrared spectroscopy imaging', 'Participants tolerated CES well without serious adverse effects', 'Feasibility and efficacy']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",30.0,0.10685,"Active CES significantly reduced scores on the Numeric Rating Scale and increased heat pain threshold, pressure pain thresholds, and conditioned pain modulation.","[{'ForeName': 'Hyochol', 'Initials': 'H', 'LastName': 'Ahn', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA. Electronic address: Hyochol.Ahn@uth.tmc.edu.'}, {'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'Galle', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Kenneth B', 'Initials': 'KB', 'LastName': 'Mathis', 'Affiliation': 'Department of Orthopedic Surgery, School of Medicine, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Miao', 'Affiliation': 'Department of Biostatistics and Data Science, School of Public Health, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Montero-Hernandez', 'Affiliation': 'Department of Engineering Technology, University of Houston, Houston, TX, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Jackson', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Hsiao-Hui', 'Initials': 'HH', 'LastName': 'Ju', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'McCrackin', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Goodwin', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Hargraves', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Bhawna', 'Initials': 'B', 'LastName': 'Jain', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dinh', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Abdul-Mooti', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Park', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Pollonini', 'Affiliation': 'Department of Engineering Technology, University of Houston, Houston, TX, USA.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2020.05.003']
711,32403243,Effects of Aerobic Exercise on Cortisol Stress Reactivity in Response to the Trier Social Stress Test in Inpatients with Major Depressive Disorders: A Randomized Controlled Trial.,"Physical activity is associated with a favourable (blunted) cortisol stress reactivity in healthy people. However, evidence from experimental study and with psychiatric patients is missing. This study examines whether exercise training impacts on cortisol stress reactivity in inpatients with major depressive disorder (MDD). These new insights are important because the stress reactivity of healthy people and patients with severe symptoms of depression might differ. Methods: The study was designed as a randomized controlled trial (trial registration number: NCT02679053). In total, 25 patients (13 women, 12 men, mean age: 38.1 12.0 years) completed a laboratory stressor task before and after a six-week intervention period. Nine samples of salivary free cortisol were taken before and after the Trier social stress test (TSST). Fourteen participants took part in six weeks of aerobic exercise training, while 11 patients were allocated to the control condition. While the primary outcome of the study was depressive symptom severity, the focus of this paper is on one of the secondary outcomes (cortisol reactivity during the TSST). The impact of aerobic exercise training was examined with a repeated-measures analysis of variance. We also examined the association between change in depression and cortisol response via correlational analysis. Cortisol reactivity did not change from baseline to post-intervention, either in the intervention or the control group. Participation in six weeks of aerobic exercise training was not associated with participants' cortisol reactivity. Moreover, depressive symptom change was not associated with change in cortisol response. Aerobic exercise training was not associated with patients' stress reactivity in this study. Because many patients initially showed a relatively flat/blunted cortisol response curve, efforts might be needed to find out which treatments are most efficient to promote a normalization of HPA axis reactivity.",2020,"Cortisol reactivity did not change from baseline to post-intervention, either in the intervention or the control group.","['25 patients (13 women, 12 men, mean age: 38.1 12.0 years', 'Fourteen participants took part in six weeks of', 'Inpatients with Major Depressive Disorders', 'inpatients with major depressive disorder (MDD', 'healthy people']","['Aerobic Exercise', 'Aerobic exercise training', 'exercise training', 'aerobic exercise training']","['cortisol stress reactivity', 'depressive symptom change', 'secondary outcomes (cortisol reactivity during the TSST', 'cortisol response', 'depressive symptom severity', 'laboratory stressor task', 'Cortisol Stress Reactivity', ""participants' cortisol reactivity"", 'Cortisol reactivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]",25.0,0.0299703,"Cortisol reactivity did not change from baseline to post-intervention, either in the intervention or the control group.","[{'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Gerber', 'Affiliation': 'Sport Science Section, Department of Sport, Exercise and Health, University of Basel, CH-4052 Basel, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Imboden', 'Affiliation': 'Psychiatric Services Solothurn, 4503 Solothurn, Switzerland.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Beck', 'Affiliation': 'Clinic Sonnenhalde, 4125 Riehen, Switzerland.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'Sport Science Section, Department of Sport, Exercise and Health, University of Basel, CH-4052 Basel, Switzerland.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Colledge', 'Affiliation': 'Sport Science Section, Department of Sport, Exercise and Health, University of Basel, CH-4052 Basel, Switzerland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Eckert', 'Affiliation': 'University Psychiatric Clinics (UPK), Neurobiology Laboratory for Brain Aging and Mental Health, University of Basel, 4002 Basel, Switzerland.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Holsboer-Trachsler', 'Affiliation': 'University Psychiatric Clinics (UPK), Center for Affective, Stress and Sleep Disorders, University of Basel, 4002 Basel, Switzerland.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Pühse', 'Affiliation': 'Sport Science Section, Department of Sport, Exercise and Health, University of Basel, CH-4052 Basel, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hatzinger', 'Affiliation': 'Psychiatric Services Solothurn, 4503 Solothurn, Switzerland.'}]",Journal of clinical medicine,['10.3390/jcm9051419']
712,32403259,Effects of 120 g/h of Carbohydrates Intake during a Mountain Marathon on Exercise-Induced Muscle Damage in Elite Runners.,"Background-exercise-induced muscle damage (EIMD) and internal exercise load are increased after competing in ultraendurance events such as mountain marathons. Adequate carbohydrate (CHO) intake during exercise optimizes athletic performance and could limit EIMD, reduce internal exercise load and, thus, improve recovery. Therefore, the aim of this study was to research into and compare the effects of high CHO intake (120 g/h) in terms of CHO intake recommendation (90 g/h) and regular CHO intake performed by ultraendurance athletes (60 g/h) during a mountain marathon, on exercise load and EIMD markers (creatine kinase (CK), lactate dehydrogenase (LDH), glutamic oxaloacetic transaminase (GOT), urea and creatinine). Materials and Methods-a randomized trial was carried out on 20 male elite runners who had previously undertaken nutritional and gut training, and who consumed different CHO dosages according to experimental (EXP-120 g/h), control (CON-90 g/h) and low CHO intake (LOW-60 g/h) groups during a ~4000 m cumulative slope mountain marathon. EIMD markers were analyzed before the race and 24 h afterwards. Internal exercise load was calculated based on rate of perceived exertion (RPE) during and after the marathon event. Results-internal exercise load during the mountain marathon was significantly lower ( p  = 0.019; η 2 p = 0.471) in EXP (3805 ± 281 AU) compared to LOW (4688 ± 705 AU) and CON (4692 ± 716 AU). Moreover, results revealed that the EXP group evidenced significantly lower CK ( p  = 0.019; η 2 p = 0.373), LDH ( p  < 0.001; η 2 p = 0.615) and GOT ( p  = 0.003; η 2 p = 0.500) values 24 h after the mountain marathon race compared to LOW and CON. Along these lines, EIMD and exercise load evidenced a close correlation (R = 0.742;  p  < 0.001). Conclusion: High CHO intake (120 g/h) during a mountain marathon could limit the EIMD observed by CK, LDH and GOT and internal exercise load compared to CHO ingestion of 60 and 90 g/h.",2020,Results-internal exercise load during the mountain marathon was significantly lower ( p  = 0.019; η 2 p = 0.471) in EXP (3805 ± 281 AU) compared to LOW (4688 ± 705 AU) and CON (4692 ± 716 AU).,"['Elite Runners', '20 male elite runners who had previously undertaken nutritional and gut training, and who consumed different CHO dosages according to experimental (EXP-120 g/h), control (CON-90 g/h) and low CHO intake (LOW-60 g/h) groups during a ~4000 m cumulative slope mountain marathon']","['high CHO intake', 'Carbohydrates Intake', '-exercise-induced muscle damage (EIMD']","['exercise load and EIMD markers (creatine kinase (CK), lactate dehydrogenase (LDH), glutamic oxaloacetic transaminase (GOT), urea and creatinine', 'rate of perceived exertion (RPE', 'regular CHO intake', 'GOT', 'CK']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0560020', 'cui_str': 'g/h'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442533', 'cui_str': 'Mountain'}, {'cui': 'C0168374', 'cui_str': 'Marathon composite resin'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",20.0,0.0227273,Results-internal exercise load during the mountain marathon was significantly lower ( p  = 0.019; η 2 p = 0.471) in EXP (3805 ± 281 AU) compared to LOW (4688 ± 705 AU) and CON (4692 ± 716 AU).,"[{'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'Viribay', 'Affiliation': 'Glut4Science, Physiology, Nutrition and Sport, 01004 Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Arribalzaga', 'Affiliation': 'Institute of Biomedicine (IBIOMED), Physiotherapy Department, University of Leon, Campus de Vegazana, 24071 Leon, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Mielgo-Ayuso', 'Affiliation': 'Department of Biochemistry Molecular Biology and Physiology, Faculty of Health Sciences, University of Valladolid, 42004 Soria, Spain.'}, {'ForeName': 'Arkaitz', 'Initials': 'A', 'LastName': 'Castañeda-Babarro', 'Affiliation': 'Health, Physical Activity and Sports Science Laboratory, Department of Physical Activity and Sports, Faculty of Psychology and Education, University of Deusto, 48007 Bizkaia, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Seco-Calvo', 'Affiliation': 'Institute of Biomedicine (IBIOMED), Physiotherapy Department, University of Leon, Researcher at the Basque Country University, Campus de Vegazana, 24071 Leon, Spain.'}, {'ForeName': 'Aritz', 'Initials': 'A', 'LastName': 'Urdampilleta', 'Affiliation': 'Centro de Investigacion y de Formación ElikaEsport, 08290 Cerdanyola del Valles, Barcelona, Spain.'}]",Nutrients,['10.3390/nu12051367']
713,32403299,Exploring the Provider-Level Socio-Demographic Determinants of Diet Quality of Preschool-Aged Children Attending Family Childcare Homes.,"Since food preferences develop during early childhood and contribute to dietary patterns that can track into adulthood, it is critical to support healthy food environments in places where children spend significant amounts of time in, such as childcare. It is important to understand what factors influence the diet quality of children cared for in family childcare homes (FCCH).
METHODS


This study used baseline data from a cluster-randomized trial in FCCH, Healthy Start/Comienzos Sanos. Surveys capturing providers' socio-demographic characteristics were completed. Food and beverage consumptions were estimated using the Dietary Observation in Childcare protocol, and diet quality was calculated using the Healthy Eating Index (HEI)-2015. Comparison of mean HEI scores by provider socio-demographic variables were completed using ANOVAs, followed by multiple linear regression models for significant variables. Post-hoc ANOVA models compared mean HEI-2015 sub-components by income and ethnicity.
RESULTS


Significant differences in mean HEI-2015 scores were found for provider income level (less than $25,000, HEI: 64.8 vs. $25,001-$50,000: 62.9 vs. $75,001 or more: 56.2;  p  = 0.03), ethnicity (Non-Latinx: 56.6 vs. Latinx: 64.4;  p  = 0.002), language spoken outside of childcare (English: 58.6 vs. Spanish: 64.3,  p  = 0.005), and language spoken in childcare (English: 59.6 vs. Spanish: 64.4;  p  = 0.02). In linear regression models, a higher provider income ($75,001 or more) was negatively and significantly associated with the total HEI-2015 scores (β = -9.8, SE = 3.7;  p  = 0.009) vs. lower income (less than $25,000). When entering provider income and ethnicity to the same model, adjusting for Child and Adult Food Program (CACFP), only ethnicity was significant, with Latinx being positively associated with total HEI-2015 scores vs. non-Latinx (β = 6.5, SE = 2.4;  p  = 0.007). Statistically significant differences were found by ethnicity and language for greens/beans, total protein, and seafood and plant protein HEI-2015 component scores.
DISCUSSION


Lower income, and Latinx providers cared-for children had higher diet quality in FCCH compared to the other providers. Future studies should better understand what specific foods contribute to each of the HEI-2015 components in order to better tailor trainings and interventions.",2020,"Statistically significant differences were found by ethnicity and language for greens/beans, total protein, and seafood and plant protein HEI-2015 component scores.
","['Preschool-Aged Children Attending Family Childcare Homes', 'children cared for in family childcare homes (FCCH']",[],"['total HEI-2015 scores', 'language spoken outside of childcare', 'higher provider income', 'mean HEI-2015 scores', 'Healthy Eating Index', 'provider income level', 'mean HEI scores', 'ethnicity and language for greens/beans, total protein, and seafood and plant protein HEI-2015 component scores', 'diet quality']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0008067', 'cui_str': 'Puericulture'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424919', 'cui_str': 'Language spoken'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0004896', 'cui_str': 'Bean'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0206208', 'cui_str': 'Seafood'}, {'cui': 'C0032089', 'cui_str': 'Plant Proteins'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.0209457,"Statistically significant differences were found by ethnicity and language for greens/beans, total protein, and seafood and plant protein HEI-2015 component scores.
","[{'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Tovar', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Kingston, RI 02881, USA.'}, {'ForeName': 'Patricia Markham', 'Initials': 'PM', 'LastName': 'Risica', 'Affiliation': 'Center for Health Promotion and Health Equity, Brown University, South Main Street, Providence, RI 02912, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ramirez', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Kingston, RI 02881, USA.'}, {'ForeName': 'Noereem', 'Initials': 'N', 'LastName': 'Mena', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Kingston, RI 02881, USA.'}, {'ForeName': 'Ingrid E', 'Initials': 'IE', 'LastName': 'Lofgren', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Kingston, RI 02881, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Cooksey Stowers', 'Affiliation': 'Department of Allied Health Sciences, University of Connecticut, 358 Mansfield Rd, Storrs, CT 06269, USA.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Gans', 'Affiliation': 'Human Development & Family Sciences, 348 Mansfield Road, Unit 1058, University of Connecticut, Storrs, CT 06269, USA.'}]",Nutrients,['10.3390/nu12051368']
714,32403341,Measuring the Development of Therapeutic-Decision-Making Skills by Practicing Pharmacists Undertaking a University-Based Postgraduate Clinical Qualification at Distance.,"(1)  Background:  The processes and skills required to make decisions about drug therapy have been termed ""therapeutic decision-making"" in pharmacy practice. The aim of this study was to evaluate a tool constructed to measure the development of therapeutic-decision-making skills by practicing pharmacists undertaking a university-based continuing professional development program. (2)  Methods:  A pre- and post-intervention crossover study design was used to investigate the qualitative and quantitative features of practicing pharmacists' responses to two clinical vignettes designed to measure the development of therapeutic-decision-making skills. The vignettes were assigned a score using a five-point scale and compared pre- and post-intervention. (3)  Results:  There was a median increase in score of 2 units on the five-point scale in the post-intervention scores compared to pre-intervention ( p  < 0.0001). (4)  Conclusions:  The results were interpreted to suggest that the participants' responses to the vignettes are a reasonable measure of student learning. Therefore, we infer that the teaching and learning intervention successfully enabled the development of therapeutic-decision-making skills by practicing pharmacists.",2020,There was a median increase in score of 2 units on the five-point scale in the post-intervention scores compared to pre-intervention ( p  < 0.0001).,['practicing pharmacists undertaking a university-based continuing professional development program'],[],[],"[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0033333', 'cui_str': 'Program development'}]",[],[],,0.0271971,There was a median increase in score of 2 units on the five-point scale in the post-intervention scores compared to pre-intervention ( p  < 0.0001).,"[{'ForeName': 'Daniel F B', 'Initials': 'DFB', 'LastName': 'Wright', 'Affiliation': 'School of Pharmacy, University of Otago, Dunedin 9054, New Zealand.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Duffull', 'Affiliation': 'School of Pharmacy, University of Otago, Dunedin 9054, New Zealand.'}, {'ForeName': 'Kyle J', 'Initials': 'KJ', 'LastName': 'Wilby', 'Affiliation': 'School of Pharmacy, University of Otago, Dunedin 9054, New Zealand.'}, {'ForeName': 'Aynsley K', 'Initials': 'AK', 'LastName': 'Peterson', 'Affiliation': 'School of Pharmacy, University of Otago, Dunedin 9054, New Zealand.'}, {'ForeName': 'Megan G', 'Initials': 'MG', 'LastName': 'Anakin', 'Affiliation': 'Education Unit, Dunedin School of Medicine, University of Otago, Dunedin 9054, New Zealand.'}]","Pharmacy (Basel, Switzerland)",['10.3390/pharmacy8020083']
715,32404389,Focus group discussions on low-flow oxygen and bubble CPAP treatments among mothers of young children in Malawi: a CPAP IMPACT substudy.,"OBJECTIVE


To determine the acceptability of bubble continuous positive airway pressure (bCPAP) and low-flow oxygen among mothers of children who had received either therapy.
SETTING


A district hospital in Salima, Malawi.
PARTICIPANTS


We conducted eight focus group discussions (FGDs) with a total of 54 participants. Eligible participants were mothers of children 1 to 59 months of age with severe pneumonia and a comorbidity (HIV-infection, HIV-exposure, malnutrition or hypoxaemia) who, with informed consent, had been enrolled in a randomised clinical trial, CPAP IMPACT (Improving Mortality for Pneumonia in African Children Trial), comparing low-flow oxygen and bCPAP treatments (ClinicalTrials.gov, NCT02484183).
PRIMARY AND SECONDARY OUTCOME MEASURES


FGDs assessed mothers' attitudes and feelings towards oxygen and bCPAP before and after therapy along with general community perceptions of respiratory therapies. Data was analysed using inductive thematic analysis to assess themes and subthemes of the transcripts.
RESULTS


Community perceptions of oxygen and bCPAP were widely negative. Mothers recounted that they are told that 'oxygen kills babies'. They are often fearful of allowing their child to receive oxygen therapy and will delay treatment or seek alternative therapies. Mothers report limiting oxygen and bCPAP by intermittently removing the nasal cannulas or mask. After oxygen or bCPAP treatment, regardless of patient outcome, mothers were supportive of the treatment their child received and would recommend it to other mothers.
CONCLUSION


There are significant community misconceptions around oxygen and bCPAP causing mothers to be fearful of either treatment. In order for low-flow oxygen treatment and bCPAP implementation to be effective, widespread community education is necessary.",2020,"After oxygen or bCPAP treatment, regardless of patient outcome, mothers were supportive of the treatment their child received and would recommend it to other mothers.
","['mothers of children who had received either therapy', 'We conducted eight focus group discussions (FGDs) with a total of 54 participants', 'A district hospital in Salima, Malawi', 'Eligible participants were mothers of children 1 to 59 months of age with severe pneumonia and a comorbidity (HIV-infection, HIV-exposure, malnutrition or hypoxaemia) who, with informed consent', 'mothers of young children in Malawi']","['bubble continuous positive airway pressure (bCPAP) and low-flow oxygen', 'bCPAP', 'CPAP IMPACT', 'low-flow oxygen and bubble CPAP treatments']","[""FGDs assessed mothers' attitudes and feelings towards oxygen and bCPAP""]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205454', 'cui_str': '8'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020006', 'cui_str': 'District hospital'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]","[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}]",54.0,0.106875,"After oxygen or bCPAP treatment, regardless of patient outcome, mothers were supportive of the treatment their child received and would recommend it to other mothers.
","[{'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Sessions', 'Affiliation': 'Pediatrics, McGaw Medical Center of Northwestern University, Chicago, Illinois, United States ksessions@luriechildrens.org.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ruegsegger', 'Affiliation': 'Project Malawi, University of North Carolina System, Lilongwe, Malawi.'}, {'ForeName': 'Tisungane', 'Initials': 'T', 'LastName': 'Mvalo', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Davie', 'Initials': 'D', 'LastName': 'Kondowe', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Mercy', 'Initials': 'M', 'LastName': 'Tsidya', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Lufesi', 'Affiliation': 'Acute Respiratory Infection Unit, Ministry of Health, Lilongwe, Malawi.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Eckerle', 'Affiliation': ""Emergency Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States.""}, {'ForeName': 'Andrew Gerald', 'Initials': 'AG', 'LastName': 'Smith', 'Affiliation': 'Pediatric Critical Care Medicine, University of Utah, Salt Lake City, Utah, United States.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'McCollum', 'Affiliation': 'Eudowood Division of Pediatric Respiratory Sciences, Johns Hopkins School of Medicine, Baltimore, Maryland, United States.'}]",BMJ open,['10.1136/bmjopen-2019-034545']
716,32404390,Effects of an automated digital brief prevention intervention targeting adolescents and young adults with risky alcohol and other substance use: study protocol for a randomised controlled trial.,"INTRODUCTION


Adolescence and young adulthood is a period in life when individuals may be especially vulnerable to harmful substance use. Several critical developmental processes are occurring in the brain, and substance use poses both short-term and long-term risks with regard to mental health and social development. From a public health perspective, it is important to prevent or delay substance use to reduce individual risk and societal costs. Given the scarcity of effective interventions targeting substance use among adolescents and young adults, cost-effective and easily disseminated interventions are warranted. The current study will test the effectiveness of a fully automated digital brief intervention aimed at reducing alcohol and other substance use in adolescents and young adults aged 15 to 25 years.
METHODS AND ANALYSIS


A two-arm, double-blind, randomised controlled trial design is applied to assess the effectiveness of the intervention. Baseline assessment, as well as 3-month and 6-month follow-up, will be carried out. The aim is to include 800 participants with risky substance use based on the screening tool CRAFFT (Car,Relax, Alone, Forget, Friends, Trouble). Recruitment, informed consent, randomisation, intervention and follow-up will be implemented online. The primary outcome is reduction in alcohol use, measured by Alcohol Use Disorders Identification Test total score. Secondary outcomes concern binge drinking, frequency of alcohol consumption, amount of alcohol consumed a typical day when alcohol is consumed, average daily drinks per typical week, other substance use, mental health, sexual risk behaviours and perceived peer pressure. Moreover, the study involves analyses of potential moderators including perfectionism, openness to parents, help-seeking and background variables.
ETHICS AND DISSEMINATION


The study was approved by the Swedish Ethical Review Authority (no. 2019-03249). The trial is expected to expand the knowledge on digital preventive interventions for substance using adolescents and young adults. Results will be disseminated in research journals, at conferences and via the media.
TRIAL REGISTRATION NUMBER


24 September 2019, ISRCTN91048246; Pre-results.",2020,"The current study will test the effectiveness of a fully automated digital brief intervention aimed at reducing alcohol and other substance use in adolescents and young adults aged 15 to 25 years.
","['adolescents and young adults aged 15 to 25 years', 'substance using adolescents and young adults', 'adolescents and young adults', 'adolescents and young adults with risky alcohol and other substance use', '800 participants with risky substance use based on the screening tool CRAFFT (Car,Relax, Alone, Forget, Friends, Trouble']",['automated digital brief prevention intervention'],"['binge drinking, frequency of alcohol consumption, amount of alcohol consumed a typical day when alcohol is consumed, average daily drinks per typical week, other substance use, mental health, sexual risk behaviours and perceived peer pressure', 'reduction in alcohol use, measured by Alcohol Use Disorders Identification Test total score']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0079382', 'cui_str': 'Friend'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0562366', 'cui_str': 'Pressured by peers'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",800.0,0.0827623,"The current study will test the effectiveness of a fully automated digital brief intervention aimed at reducing alcohol and other substance use in adolescents and young adults aged 15 to 25 years.
","[{'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Kvillemo', 'Affiliation': 'STAD (Stockholm Prevents Alcohol and Drug Problems), Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden pia.kvillemo@ki.se.'}, {'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Strandberg', 'Affiliation': 'STAD (Stockholm Prevents Alcohol and Drug Problems), Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Gripenberg', 'Affiliation': 'STAD (Stockholm Prevents Alcohol and Drug Problems), Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Berman', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Skoglund', 'Affiliation': 'STAD (Stockholm Prevents Alcohol and Drug Problems), Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Tobias H', 'Initials': 'TH', 'LastName': 'Elgán', 'Affiliation': 'STAD (Stockholm Prevents Alcohol and Drug Problems), Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}]",BMJ open,['10.1136/bmjopen-2019-034894']
717,32404430,Graduated compression stockings as adjuvant to pharmaco-thromboprophylaxis in elective surgical patients (GAPS study): randomised controlled trial.,"OBJECTIVES


To investigate whether the use of graduated compression stockings (GCS) offers any adjuvant benefit when pharmaco-thromboprophylaxis is used for venous thromboembolism prophylaxis in patients undergoing elective surgery.
DESIGN


Open, multicentre, randomised, controlled, non-inferiority trial.
SETTING


Seven National Health Service tertiary hospitals in the United Kingdom.
PARTICIPANTS


1905 elective surgical inpatients (≥18 years) assessed as being at moderate or high risk of venous thromboembolism were eligible and consented to participate.
INTERVENTION


Participants were randomly assigned (1:1) to receive low molecular weight heparin (LMWH) pharmaco-thromboprophylaxis alone or LMWH pharmaco-thromboprophylaxis and GCS.
OUTCOME MEASURES


The primary outcome was imaging confirmed lower limb deep vein thrombosis with or without symptoms, or pulmonary embolism with symptoms within 90 days of surgery. Secondary outcome measures were quality of life, compliance with stockings and LMWH, lower limb complications related to GCS, bleeding complications, adverse reactions to LMWH, and all cause mortality.
RESULTS


Between May 2016 and January 2019, 1905 participants were randomised. 1858 were included in the intention to treat analysis (17 were identified as ineligible after randomisation and 30 did not undergo surgery). A primary outcome event occurred in 16 of 937 (1.7%) patients in the LMWH alone group compared with 13 of 921 (1.4%) in the LMWH and GCS group. The risk difference between the two groups was 0.30% (95% confidence interval -0.65% to 1.26%). Because the 95% confidence interval did not cross the non-inferiority margin of 3.5% (P<0.001 for non-inferiority), LMWH alone was confirmed to be non-inferior.
CONCLUSIONS


For patients who have elective surgery and are at moderate or high risk of venous thromboembolism, administration of pharmaco-thromboprophylaxis alone is non-inferior to a combination of pharmaco-thromboprophylaxis and GCS. These findings indicate that GCS might be unnecessary in most patients undergoing elective surgery.
TRIAL REGISTRATION


ISRCTN13911492.",2020,"Because the 95% confidence interval did not cross the non-inferiority margin of 3.5% (P<0.001 for non-inferiority), LMWH alone was confirmed to be","['1905 elective surgical inpatients (≥18 years) assessed as being at moderate or high risk of venous thromboembolism were eligible and consented to participate', 'patients who have elective surgery and are at moderate or high risk of venous thromboembolism', 'patients undergoing elective surgery', 'Seven National Health Service tertiary hospitals in the United Kingdom', '1858 were included in the intention to treat analysis (17 were identified as ineligible after randomisation and 30 did not undergo surgery', 'elective surgical patients (GAPS study', 'Between May 2016 and January 2019, 1905 participants were randomised']","['low molecular weight heparin (LMWH) pharmaco-thromboprophylaxis alone or LMWH pharmaco-thromboprophylaxis and GCS', 'LMWH', 'Graduated compression stockings', 'graduated compression stockings (GCS', 'GCS']","['imaging confirmed lower limb deep vein thrombosis with or without symptoms, or pulmonary embolism with symptoms', 'quality of life, compliance with stockings and LMWH, lower limb complications related to GCS, bleeding complications, adverse reactions to LMWH, and all cause mortality']","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0340708', 'cui_str': 'Deep venous thrombosis of lower extremity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0445269', 'cui_str': 'Socks'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",1905.0,0.261781,"Because the 95% confidence interval did not cross the non-inferiority margin of 3.5% (P<0.001 for non-inferiority), LMWH alone was confirmed to be","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Shalhoub', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London & Imperial Vascular Unit, Imperial College Healthcare NHS Trust, London W6 8RF, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lawton', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London & Imperial Vascular Unit, Imperial College Healthcare NHS Trust, London W6 8RF, UK.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Baker', 'Affiliation': 'Department of Cardiology, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bradbury', 'Affiliation': 'University of Birmingham & University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Dhillon', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London & Imperial Vascular Unit, Imperial College Healthcare NHS Trust, London W6 8RF, UK.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Everington', 'Affiliation': 'Hampshire Hospitals NHS Foundation Trust, Hampshire, UK.'}, {'ForeName': 'Manjit S', 'Initials': 'MS', 'LastName': 'Gohel', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London & Imperial Vascular Unit, Imperial College Healthcare NHS Trust, London W6 8RF, UK.'}, {'ForeName': 'Zaed', 'Initials': 'Z', 'LastName': 'Hamady', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Beverley J', 'Initials': 'BJ', 'LastName': 'Hunt', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Gerrard', 'Initials': 'G', 'LastName': 'Stansby', 'Affiliation': 'Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Warwick', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Alun H', 'Initials': 'AH', 'LastName': 'Davies', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London & Imperial Vascular Unit, Imperial College Healthcare NHS Trust, London W6 8RF, UK a.h.davies@imperial.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ (Clinical research ed.),['10.1136/bmj.m1309']
718,32404518,"Impact of flavors and humectants on waterpipe tobacco smoking topography, subjective effects, toxicant exposure and intentions for continued use.","INTRODUCTION


The present study examined how the lack of characterising flavours and low levels of humectants may affect users' waterpipe tobacco (WT) smoking topography, subjective effects, toxicant exposure and intentions for continued use.
METHODS


89 WT smokers completed four ad libitum smoking sessions (characterising flavor/high humectant (+F+H); characterising flavor/low humectant (+F-H); no characterising flavor/high humectant (-F+H); no characterising flavor/low humectant (-F-H)) in a randomised cross-over design. WT was commercially available; same brand but nicotine levels were not held constant. A subsample (n=50) completed a standardised, 10-puff session preceding ad libitum smoking. Participants completed questionnaires, exhaled carbon monoxide (eCO) testing and provided blood samples for plasma nicotine. Smoking topography was measured throughout the session. Post hoc analyses showed that -F+H and -F-H did not differ significantly in humectant levels. Therefore, these groups were collapsed in analyses (-F-H).
RESULTS


WT smokers reported significantly greater satisfaction, liking, enjoyment and greater intentions for continued use when smoking +F+H compared with other WT products, with -F-H receiving the lowest ratings. Significant differences in topography were observed during standardised and ad libitum sessions, with the -F-H preparation leading to greater total inhaled volume and eCO boost, but lower nicotine boost compared with +F+H (all p<0.05).
DISCUSSION


The findings demonstrate the importance of flavours and humectants on improving WT smoking experience and increasing the likelihood that users will want to initiate and continue smoking. Moreover, it demonstrates that flavours and humectants influence smoking behaviour and toxicant exposure in some unexpected ways that are important for regulatory efforts.",2020,Post hoc analyses showed that -F+H and -F-H did not differ significantly in humectant levels.,['89 WT smokers completed four'],['ad libitum smoking sessions (characterising flavor/high humectant (+F+H); characterising flavor/low humectant (+F-H'],"['questionnaires, exhaled carbon monoxide (eCO) testing and provided blood samples for plasma nicotine', 'Smoking topography', 'waterpipe tobacco smoking topography, subjective effects, toxicant exposure and intentions', 'satisfaction, liking, enjoyment and greater intentions', 'F+H\u2009and -F-H']","[{'cui': 'C4505131', 'cui_str': 'Waterpipe Tobacco'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2936383', 'cui_str': 'Humectants'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C4505131', 'cui_str': 'Waterpipe Tobacco'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",89.0,0.0109458,Post hoc analyses showed that -F+H and -F-H did not differ significantly in humectant levels.,"[{'ForeName': 'Theodore L', 'Initials': 'TL', 'LastName': 'Wagener', 'Affiliation': 'Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus, Ohio, USA Theodore.Wagener@osumc.edu.'}, {'ForeName': 'Eleanor L S', 'Initials': 'ELS', 'LastName': 'Leavens', 'Affiliation': 'Department of Population Health, University of Kansas School of Medicine, Kasas City, Kansas, United States.'}, {'ForeName': 'Toral', 'Initials': 'T', 'LastName': 'Mehta', 'Affiliation': 'Center for Tobacco Research, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hale', 'Affiliation': 'Center for Tobacco Research, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Shihadeh', 'Affiliation': 'Department of Mechanical Engineering, American University of Beirut, Beirut, Lebanon.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eissenberg', 'Affiliation': 'Center for the Study of Tobacco Products, Department of Psychology, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Halquist', 'Affiliation': 'Department of Pharmaceutics, School of Pharmacy, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Marielle C', 'Initials': 'MC', 'LastName': 'Brinkman', 'Affiliation': 'Center for Tobacco Research, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Johnson', 'Affiliation': 'Oklahoma Tobacco Research Center, Stephenson Cancer Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Evan L', 'Initials': 'EL', 'LastName': 'Floyd', 'Affiliation': 'Department of Occupational and Environmental Health, University of Oklahoma - Health Sciences Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Ding', 'Affiliation': 'Department of Biostatistics and Epidemiology, Hudson College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'El Hage', 'Affiliation': 'Department of Chemistry, American University of Beirut, Beirut, Lebanon.'}, {'ForeName': 'Rola', 'Initials': 'R', 'LastName': 'Salman', 'Affiliation': 'Department of Mechanical Engineering, American University of Beirut, Beirut, Lebanon.'}]",Tobacco control,['10.1136/tobaccocontrol-2019-055509']
719,32405701,Intraocular pressure increases during dynamic resistance training exercises according to the exercise phase in healthy young adults.,"PURPOSE


To determine the intraocular pressure (IOP) changes caused by the execution of lower body and upper body resistance training exercises leading to muscular failure depending on the exercise phase (concentric vs. eccentric). We also assessed the influence of the exercise type (back squat vs. biceps curl) and level of effort on the IOP response.
METHODS


Nineteen physically active young adults performed four sets (2 exercise type × 2 exercise phase) of 10 repetitions leading to muscular failure while adopting a normal breathing pattern. IOP was measured by rebound tonometry at baseline, after each of the ten repetitions, and after 1 min of recovery.
RESULTS


There was a main effect of the exercise phase (p < 0.001, η 2  = 0.56), observing greater IOP values in the eccentric condition of the back squat and concentric condition of the biceps curl. Also, greater IOP values were obtained for the back squat in comparison with the biceps curl (p < 0.001, η 2  = 0.61), and IOP progressively increases with the level of accumulated effort (p < 0.001, η 2  = 0.88; Pearson r = 0.97-0.98).
CONCLUSIONS


IOP fluctuates during the different phases of the repetition in dynamic resistance training exercises, being greater IOP values observed during the more physically demanding phases of the exercise (eccentric phase of the back squat and concentric phase of the biceps curl). A heightened IOP response is positively associated with muscle size (back squat > biceps curl) and with the level of effort (number of accumulated repetitions). Based on these findings, highly demanding dynamic resistance training should be avoided when maintaining stable IOP levels is desirable.",2020,"There was a main effect of the exercise phase (p < 0.001, η 2  = 0.56), observing greater IOP values in the eccentric condition of the back squat and concentric condition of the biceps curl.","['Nineteen physically active young adults', 'healthy young adults']","['dynamic resistance training exercises', 'exercise type × 2 exercise phase) of 10 repetitions leading to muscular failure while adopting a normal breathing pattern']","['greater IOP values', 'IOP', 'IOP response', 'Intraocular pressure', 'IOP values', 'intraocular pressure (IOP) changes']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0231795', 'cui_str': 'Normal respiratory function'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",19.0,0.0291437,"There was a main effect of the exercise phase (p < 0.001, η 2  = 0.56), observing greater IOP values in the eccentric condition of the back squat and concentric condition of the biceps curl.","[{'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Vera', 'Affiliation': 'Department of Optics, Faculty of Sciences, University of Granada, Campus Fuentenueva, 18071, Granada, Spain.'}, {'ForeName': 'Beatríz', 'Initials': 'B', 'LastName': 'Redondo', 'Affiliation': 'Department of Optics, Faculty of Sciences, University of Granada, Campus Fuentenueva, 18071, Granada, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Perez-Castilla', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Raimundo', 'Initials': 'R', 'LastName': 'Jiménez', 'Affiliation': 'Department of Optics, Faculty of Sciences, University of Granada, Campus Fuentenueva, 18071, Granada, Spain. raimundo@ugr.es.'}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García-Ramos', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-020-04736-2']
720,32405757,Attention-enhancing effects of propranolol and synergistic effects with nicotine.,"Nicotine increases the output of every major neurotransmitter. In previous studies designed to identify the secondary neurotransmitter systems mediating nicotine's attention-enhancing effects in a rat model, the β-adrenoceptor antagonist propranolol blocked these effects. The present study was designed to test whether this mechanism held true in humans, thus guiding development of novel nicotinic agonists for cognitive enhancement. Twenty-six nonsmokers completed a nicotine (7 mg/24 h transdermally) x propranolol (40 mg p.o., body weight-adjusted) interaction study. Over four test days, each participant received double-placebo, nicotine only, propranolol only, and nicotine plus propranolol in randomized sequence before cognitive testing. No drug effects were seen in a visuospatial attention task. In the Rapid Visual Information Processing Task, performed in two 15-min blocks, neither drug alone significantly affected hit rate, but both drugs combined acted synergistically to alleviate its decrement over time in the first block and displayed additive beneficial effects in the second. In a change detection task, propranolol enhanced accuracy and reduced reaction time independent of nicotine presence. Propranolol also enhanced subjective self-reports of vigor. Overall, the findings were contrary to those hypothesized. Propranolol displayed beneficial effects on cognition, especially on sustaining performance over time. β-adrenoceptor activation by nicotine-induced noradrenaline release appeared to limit performance-enhancing effects of nicotine, because they were unmasked by β-adrenoceptor antagonism. The results suggest that cognitive effects of changes in β-adrenoceptor tone are context-dependent; contrary to rodent paradigms, human cognitive paradigms require no physical orienting in space but prolonged periods of remaining stationary while sustaining predictable processing demands.",2020,"In the Rapid Visual Information Processing Task, performed in two 15-min blocks, neither drug alone significantly affected hit rate, but both drugs combined acted synergistically to alleviate its decrement over time in the first block and displayed additive beneficial effects in the second.",['Twenty-six nonsmokers completed a nicotine (7 mg/24 h transdermally'],"['double-placebo, nicotine only, propranolol only, and nicotine plus propranolol', 'nicotine', 'Nicotine', 'Propranolol', 'propranolol']","['visuospatial attention task', 'output of every major neurotransmitter']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027908', 'cui_str': 'Neurotransmitter'}]",,0.0267626,"In the Rapid Visual Information Processing Task, performed in two 15-min blocks, neither drug alone significantly affected hit rate, but both drugs combined acted synergistically to alleviate its decrement over time in the first block and displayed additive beneficial effects in the second.","[{'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Hahn', 'Affiliation': 'Department of Psychiatry, Maryland Psychiatric Research Center, University of Maryland School of Medicine, P.O. Box 21247, Baltimore, MD, 21228, USA. bhahn@som.umaryland.edu.'}, {'ForeName': 'Cory K', 'Initials': 'CK', 'LastName': 'Olmstead', 'Affiliation': 'Department of Psychiatry, Maryland Psychiatric Research Center, University of Maryland School of Medicine, P.O. Box 21247, Baltimore, MD, 21228, USA.'}, {'ForeName': 'Marie B', 'Initials': 'MB', 'LastName': 'Yuille', 'Affiliation': 'Department of Psychiatry, Maryland Psychiatric Research Center, University of Maryland School of Medicine, P.O. Box 21247, Baltimore, MD, 21228, USA.'}, {'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Chiappelli', 'Affiliation': 'Department of Psychiatry, Maryland Psychiatric Research Center, University of Maryland School of Medicine, P.O. Box 21247, Baltimore, MD, 21228, USA.'}, {'ForeName': 'Ashleigh K', 'Initials': 'AK', 'LastName': 'Wells', 'Affiliation': 'Department of Psychiatry, Maryland Psychiatric Research Center, University of Maryland School of Medicine, P.O. Box 21247, Baltimore, MD, 21228, USA.'}]","Cognitive, affective & behavioral neuroscience",['10.3758/s13415-020-00794-5']
721,32405884,Effect of patient-specific instrument on lowering threshold for junior physicians to perform total hip arthroplasty on developmental dysplasia of the hip patients.,"PURPOSE


To create a patient-specific instrument (PSI) in lowering the surgical experience requirement for junior physicians to perform total hip arthroplasty (THA) on developmental dysplasia of the hip (DDH) patients.
METHODS


Combined with rapid prototyping technology, we created a PSI and established DDH hip model in vitro. We enrolled 48 junior physicians and randomly assigned them into two groups. After creation of the PSI, they performed simulated THA surgery on a full-scale hip model with or without PSI on DDH models. The planned prothesis orientation, post-operative prothesis orientation, and surgery time were recorded.
RESULTS


The final cup inclination was 42.0 ± 0.8° in PSI group and 37.8 ± 2.0° in control group, while final cup anteversion was 16.0 ± 0.7° in PSI group and 24.7 ± 3.5° in control group. The △inclination in PSI group was smaller than that in control group (4.2 ± 0.5° vs 9.5 ± 1.4°, P < 0.01), so does △inclination (2.9 ± 0.4° in PSI group vs 15.2 ± 2.5° in control group, P < 0.01). The outlier percent was 8.3% in PSI group and 70.8% in control group (P < 0.01). At the same time, the PSI group did not prolong the operation time (P = 0.551).
CONCLUSION


The PSI can greatly increase the accuracy of placing the cup orientation and lower the threshold for junior physicians to perform THA on DDH patients. It could be a training tool for them to increase their THA surgical skills.",2020,The outlier percent was 8.3% in PSI group and 70.8% in control group (P < 0.01).,"['junior physicians to perform total hip arthroplasty (THA) on developmental dysplasia of the hip (DDH) patients', '48 junior physicians', 'junior physicians to perform total hip arthroplasty on developmental dysplasia of the hip patients']","['patient-specific instrument (PSI', 'patient-specific instrument', 'rapid prototyping technology']",['operation time'],"[{'cui': 'C0524635', 'cui_str': 'Physicians, Junior'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C4551649', 'cui_str': 'Congenital hip dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",48.0,0.0184023,The outlier percent was 8.3% in PSI group and 70.8% in control group (P < 0.01).,"[{'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': 'Department of Sports Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Chenggong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Digital Orthopaedic Laboratory, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Zhong', 'Affiliation': 'Digital Orthopaedic Laboratory, Xiangya Hospital, Central South University, Changsha, Hunan, China. Dr_zhongda@126.com.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Lei', 'Affiliation': 'Digital Orthopaedic Laboratory, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Yihe', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Digital Orthopaedic Laboratory, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Shilong', 'Initials': 'S', 'LastName': 'Su', 'Affiliation': 'Digital Orthopaedic Laboratory, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}]",International orthopaedics,['10.1007/s00264-020-04599-6']
722,32405975,A randomized-controlled trial of sugammadex versus neostigmine: impact on early postoperative strength.,"BACKGROUND


Residual neuromuscular blockade after surgery is associated with airway obstruction, hypoxia, and respiratory complications. Compared with neostigmine, sugammadex reverses neuromuscular blockade to a train-of-four ratio > 0.9 more rapidly. It is unknown, however, whether the superior reversal profile of sugammadex improves clinically relevant measures of strength in the early postoperative period.
METHODS


Patients undergoing general, gynecological, or urologic surgery were randomized to receive either neostigmine (70 µg·kg -1 , maximum 5 mg) or sugammadex (2 or 4 mg·kg -1 ) to reverse neuromuscular blockade. The primary outcome was the ability to breathe deeply measured by incentive spirometry at 30, 60, and 120 min after reversal.
RESULTS


We randomized 62 patients to either a neostigmine (n = 31) or sugammadex (n = 31) group. The incentive spirometry volume recovery trajectory was not different between the two groups (P = 0.35). Median spirometry volumes at baseline, 30, 60, and 120 min postoperatively were 2650 vs 2500 mL, 1775 vs 1750 mL, 1375 vs 2000 mL, and 1800 vs 1950 mL for the sugammadex and neostigmine groups, respectively. Postoperative incentive spirometry decrease from baseline was not different between the two groups. Hand grip strength, the ability to sit unaided, train-of-four ratio on postanesthesia care unit (PACU) admission, time to extubation, time to PACU discharge readiness, and Quality of Recovery-15 scores were also not different between the groups.
CONCLUSIONS


Measures of postoperative strength, such as incentive spirometry, hand group strength, and the ability to sit up in the early postoperative period were not different in patients who received neostigmine or sugammadex for the reversal of neuromuscular blockade.
TRIAL REGISTRATION


www.clinicaltrials.gov (NCT02909439); registered: 21 September, 2016.",2020,The incentive spirometry volume recovery trajectory was not different between the two groups (P = 0.35).,"['Patients undergoing general, gynecological, or urologic surgery']","['sugammadex', 'neostigmine, sugammadex', 'neostigmine or sugammadex', 'neostigmine', 'neostigmine (70 µg·kg -1 , maximum 5 mg) or sugammadex (2 or 4 mg·kg -1 ) to reverse neuromuscular blockade']","['Median spirometry volumes', 'Hand grip strength, the ability to sit unaided, train-of-four ratio on postanesthesia care unit (PACU) admission, time to extubation, time to PACU discharge readiness, and Quality of Recovery-15 scores', 'early postoperative strength', 'Postoperative incentive spirometry decrease', 'incentive spirometry volume recovery trajectory', 'ability to breathe deeply measured by incentive spirometry']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0038913', 'cui_str': 'Procedure, Urologic Surgical'}]","[{'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0560879', 'cui_str': 'Ability to sit'}, {'cui': 'C0439846', 'cui_str': 'Unaided'}, {'cui': 'C0428698', 'cui_str': 'Train of four ratio'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0454512', 'cui_str': 'Incentive spirometry'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0566501', 'cui_str': 'Ability to breathe'}, {'cui': 'C4554317', 'cui_str': 'Deeply'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",62.0,0.373182,The incentive spirometry volume recovery trajectory was not different between the two groups (P = 0.35).,"[{'ForeName': 'Ramon E', 'Initials': 'RE', 'LastName': 'Abola', 'Affiliation': 'Department of Anesthesiology, Stony Brook Medicine, Stony Brook, NY, 11794, USA. Ramon.abola@stonybrookmedicine.edu.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Romeiser', 'Affiliation': 'Department of Anesthesiology, Stony Brook Medicine, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Sabeen', 'Initials': 'S', 'LastName': 'Rizwan', 'Affiliation': 'Department of Anesthesiology, Stony Brook Medicine, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Lung', 'Affiliation': 'Department of Anesthesiology, Stony Brook Medicine, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Ruchir', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Anesthesiology, Stony Brook Medicine, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Elliott', 'Initials': 'E', 'LastName': 'Bennett-Guerrero', 'Affiliation': 'Department of Anesthesiology, Stony Brook Medicine, Stony Brook, NY, 11794, USA.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-020-01695-4']
723,32033935,Effect on efficacy and safety trial outcomes of also enrolling patients on ongoing glucocorticoid therapy in rheumatoid arthritis clinical trials of tocilizumab or adalimumab or methotrexate monotherapy.,"BACKGROUND


In rheumatoid arthritis (RA) trials, inclusion of patients on background treatment with glucocorticoids (GCs) might impact efficacy and safety outcomes.
OBJECTIVES


To determine if inclusion of patients on background GC use influenced efficacy and safety outcomes of RA randomised clinical trials on initiation of tocilizumab (TCZ) or adalimumab (ADA) or methotrexate (MTX) monotherapy.
METHODS


Data of four double-blind RA randomised controlled trials (AMBITION, ACT-RAY, ADACTA and FUNCTION) with in total four TCZ, one ADA and two MTX monotherapy arms were analysed. Analyses of covariance of changes from baseline to week 24 in efficacy endpoints and radiographic progression up to week 104 were performed, correcting for relevant covariates. Incidence rates of serious adverse events (SAEs) were assessed.
RESULTS


No statistically significant differences were found in efficacy parameters between background GC users and non-GC users, except for less radiographic progression associated with GC usage in one MTX arm. SAE rates were not statistically significantly different between GC users and non-GC users in the treatment arms.
CONCLUSION


No effect of including patients on background GC treatment on efficacy and safety trial outcomes was found, with the exception of reduced radiological joint damage in one MTX arm.",2020,"No statistically significant differences were found in efficacy parameters between background GC users and non-GC users, except for less radiographic progression associated with GC usage in one MTX arm.",[],"['glucocorticoids (GCs', 'tocilizumab or adalimumab or methotrexate monotherapy', 'tocilizumab (TCZ) or adalimumab (ADA) or methotrexate (MTX) monotherapy', 'glucocorticoid therapy']","['radiographic progression', 'SAE rates', 'Incidence rates of serious adverse events (SAEs', 'efficacy parameters', 'radiological joint damage']",[],"[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}]",,0.179938,"No statistically significant differences were found in efficacy parameters between background GC users and non-GC users, except for less radiographic progression associated with GC usage in one MTX arm.","[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Safy-Khan', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands marysafy@hotmail.com.'}, {'ForeName': 'Johannes W G', 'Initials': 'JWG', 'LastName': 'Jacobs', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Maria J H', 'Initials': 'MJH', 'LastName': 'de Hair', 'Affiliation': 'Novartis Pharma BV, Amsterdam, The Netherlands.'}, {'ForeName': 'Paco M J', 'Initials': 'PMJ', 'LastName': 'Welsing', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Edwardes', 'Affiliation': 'Everest Clinical Research Canada, Markham, Ontario, Canada.'}, {'ForeName': 'Xavier M', 'Initials': 'XM', 'LastName': 'Teitsma', 'Affiliation': 'F Hoffmann-La Roche AG, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Luder', 'Affiliation': ''}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Devenport', 'Affiliation': 'F Hoffmann-La Roche AG, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Jacob M', 'Initials': 'JM', 'LastName': 'van Laar', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Attila', 'Initials': 'A', 'LastName': 'Pethoe-Schramm', 'Affiliation': 'F Hoffmann-La Roche AG, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Johannes W J', 'Initials': 'JWJ', 'LastName': 'Bijlsma', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216537']
724,32402555,Spectral-Domain OCT Analysis of Risk Factors for Macular Atrophy Development in the HARBOR Study for Neovascular Age-Related Macular Degeneration.,"PURPOSE


To identify baseline risk factors for macular atrophy (MA) development in HARBOR via a longitudinal assessment of monthly spectral-domain (SD)-OCT scans. Previous analyses of MA in HARBOR examined data from color fundus photography (CFP) and fluorescein angiography (FA).
DESIGN


Retrospective, post hoc analysis of SD-OCT images from HARBOR (ClinicalTrials.gov identifier, NCT00891735), a phase 3, multicenter, prospective, randomized, double-blind, active treatment-controlled clinical trial.
PARTICIPANTS


Patients (N = 1097) with subfoveal choroidal neovascularization secondary to neovascular age-related macular degeneration (nAMD) treated with intravitreal ranibizumab 0.5 mg monthly (n = 275), 0.5 mg pro re nata (PRN) after 3 loading doses (n = 275), 2.0 mg monthly (n = 274), or 2.0 mg PRN (n = 273).
METHODS


Evaluable SD-OCT macular cube scans from patients with 24 months of follow-up (N = 941) were examined monthly from baseline to month 24 by masked reading center-trained graders. Atrophy diagnosis criteria were consistent with those proposed by the Classification of Atrophy Meetings (CAM) group: hypertransmission of light into the choroid, loss of retinal pigment epithelium, and loss of outer retinal layers. Multivariable proportional hazards regression was performed for time to atrophy development.
MAIN OUTCOME MEASURES


Risk factors for MA as determined by time to MA development over 24 months of treatment.
RESULTS


Baseline risk factors for MA were confirmed from prior analyses that used CFP and FA data: absence of subretinal fluid, presence of intraretinal cysts, presence of Type 3 neovascularization, and presence of atrophy in the fellow eye. This analysis of SD-OCT data identified new baseline risk factors for MA: higher central drusen volume, lower choroidal thickness, presence of nascent atrophy, presence of reticular pseudodrusen, and increased central foveal thickness. Ranibizumab treatment regimen and dose level were not found to be risk factors for MA development.
CONCLUSIONS


In this analysis of a major nAMD trial using CAM atrophy criteria, new baseline risk factors for MA development were identified using an SD-OCT dataset. Risk factors for MA development identified by prior analyses were confirmed. Monthly treatment with ranibizumab 0.5 mg was not found to be a risk factor for MA development over 24 months.",2020,Monthly treatment with ranibizumab 0.5 mg was not found to be a risk factor for MA development over 24 months.,"['Evaluable SD-OCT macular cube scans from patients with 24 months of follow-up', 'Patients (N\xa0= 1097) with subfoveal choroidal neovascularization secondary to neovascular age-related macular degeneration (nAMD) treated with']","['Ranibizumab', 'intravitreal ranibizumab 0.5 mg monthly (n\xa0= 275), 0.5 mg pro re nata (PRN', 'ranibizumab']",['central foveal thickness'],"[{'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0067792', 'cui_str': 'N-acetyltryptophanamide'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",1097.0,0.0829013,Monthly treatment with ranibizumab 0.5 mg was not found to be a risk factor for MA development over 24 months.,"[{'ForeName': 'SriniVas R', 'Initials': 'SR', 'LastName': 'Sadda', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California. Electronic address: ssadda@doheny.org.'}, {'ForeName': 'Nizar Saleh', 'Initials': 'NS', 'LastName': 'Abdelfattah', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Jianqin', 'Initials': 'J', 'LastName': 'Lei', 'Affiliation': ""Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Marion', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Morgenthien', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Shamika', 'Initials': 'S', 'LastName': 'Gune', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Siva', 'Initials': 'S', 'LastName': 'Balasubramanian', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California.'}]",Ophthalmology,['10.1016/j.ophtha.2020.03.031']
725,32402558,Modified sensory stimulation using breastmilk for reducing pain intensity in neonates in Indonesia: A randomized controlled trial.,"PURPOSE


Several studies have shown that oral sucrose reduces pain in newborns. However, sucrose has no efficacy in eliminating pain and long-term effects remain unclear. Breast milk may be useful as an alternative, safe sweet solution. Sensorial saturation (SS) is a multisensory analgesic non-pharmacological treatment, which includes touch and sounds as distractors. This study aimed to compare the analgesic effects of SS with sucrose (SSS), SS with breast milk (SSB), and oral sucrose alone (S24%) in neonates undergoing venipuncture.
DESIGN AND METHODS


This was a randomized controlled trial conducted on 108 neonates who underwent venipuncture at neonatology wards. All babies were randomly assigned to one of three groups: two intervention groups and one control group. Pain response was assessed using the premature infant pain profile-revised (PIPP-R). Data analysis was conducted using the Kruskal-Wallis test and Mann-Whitney U test.
RESULTS


SSB and SSS were more effective than S24% (p = 0.001). No difference was observed between SSB and SSS (p = 0.669).
CONCLUSION


Multisensory stimulation is more effective in reducing pain than unimodal (oral sucrose) analgesia. Breast milk can be used as a sensory gustatory stimulus in multisensory stimulation to reduce pain intensity in neonates, and demonstrates a similar analgesic effect to sucrose.
PRACTICE IMPLICATIONS


The study findings suggest that neonatal nurses could use SSB for management of pain. This intervention could serve as an effective, inexpensive, and safe non-pharmacological analgesic. Additional testing of this intervention is warranted to support its use as an evidence-based pain reduction approach.",2020,"RESULTS


SSB and SSS were more effective than S24% (p = 0.001).","['108 neonates who underwent venipuncture at neonatology wards', 'newborns', 'neonates in Indonesia', 'neonates undergoing venipuncture']","['Modified sensory stimulation', 'Multisensory stimulation', 'SS with sucrose (SSS), SS with breast milk (SSB), and oral sucrose alone (S24', 'Sensorial saturation (SS']","['pain intensity', 'Pain response', 'premature infant pain profile-revised (PIPP-R', 'pain', 'SSB and SSS']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0027621', 'cui_str': 'Neonatology'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0150763', 'cui_str': 'Sensory stimulation'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}]",108.0,0.149747,"RESULTS


SSB and SSS were more effective than S24% (p = 0.001).","[{'ForeName': 'Siti Yuyun Rahayu', 'Initials': 'SYR', 'LastName': 'Fitri', 'Affiliation': 'Pediatric nursing department, Faculty of nursing, Universitas Padjadjaran, Bandung, Indonesia. Electronic address: siti.yuyun@unpad.ac.id.'}, {'ForeName': 'Lely', 'Initials': 'L', 'LastName': 'Lusmilasari', 'Affiliation': 'Pediatric and maternity nursing department, Faculty of medicine, public health and nursing, Universitas Gadjah Mada, Indonesia.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Juffrie', 'Affiliation': 'Pediatric department, Faculty of medicine, public health and nursing, Universitas Gadjah Mada, Indonesia.'}, {'ForeName': 'Carlo Valerio', 'Initials': 'CV', 'LastName': 'Bellieni', 'Affiliation': 'Neonatal Intensive Care Unit, Siena University Hospital, Italy.'}]",Journal of pediatric nursing,['10.1016/j.pedn.2020.04.004']
726,32403962,The effect of antithrombotic therapy on the recurrence of placenta-mediated diseases in pregnancy.,"Objectives:  To analyze the recurrence rate of placenta-mediated diseases (PMDs) such as preeclampsia (PE) and/or intrauterine growth restriction (IUGR), intrauterine fetal death (IUFD), and placental abruption (PA) in high-risk patients on antithrombotic therapy (AT) because of a previous obstetrical history for such complications. Methods:  The study group (SG) included 150 patients to whom either 100 mg of aspirin or low-molecular weight heparin (LMWH) was administered due to a previous history of PMDs. The AT in the SG was started before 16 gestational weeks (g.w.). The patients in the first control group (CG-1) were 150 who also had a previous obstetrical history of PMDs, but did not receive antithrombotic therapy (AT) throughout their ongoing pregnancies. The second CG (CG-2) comprised 320 patients with a previous history of normally developing pregnancies and without AT throughout their ongoing pregnancies. Results:  The total percentage of PE in pregnant patients from the SG was 25.3% (38/150 patients), with 22.2% (10/45) in the SG on AT only with LDA (SG-LDA group), 25% (17/68) in the SG on AT only with LMWHs (SG-LMWH group) and 29.7% (11/37) in the SG on combined AT with LDA and LMWHs (SG-LDA + LMWH group), as opposed to 18.67% (28/150) in CG-1 and 0.62% (2/320) in CG-2. The recurrent severe PE/total PE ratio in the SG was 44.7% (17/38), with 30% (3/10) in the SG-LDA group, 47% (8/17) in the SG-LMWH group and 54% (6/11) in the SG-LDA + LMWH group, against 75% (21/28) in CG-1. There were no cases with severe PE in CG-2. All cases with recurrent IUGR from the SG were equal to 13.3% (20/150), with 13.3% (6/45) in the SG-LDA group, 11.76% (8/68) in the SG-LMWH group and 16.2% (6/37) in the SG-LDA + LMWH group, as compared to 30% (45/150) in CG-1 and 5% (16/320) in CG-2. As a whole, the overall recurrence rate of PMDs in the SG was 38.67% (58/150), with 35.56% (16/45) in the SG-LDA group, 36.76% (25/68) in the SG-LMWH group and 45.9% (17/37) in the SG-LDA + LMWH group, as compared to 50.67% (76/150) in CG-1 and 5.94% (19/320) in CG-2. Conclusion:  AT had a partial beneficial effect on the prophylaxis of recurrent PMDs. On the one hand, AT led to a significant reduction in the recurrent severe PE/total PE ratio, as well as in the total PMDs' recurrence rate in the SG as compared to the one in CG-1. On the other hand, the percentage of recurrent PMDs still remained significantly higher in the SG as compared to CG-2. Pregnant patients with previous PMDs still need close surveillance in subsequent pregnancies as they remain at a high risk for complications.",2020,"On the other hand, the percentage of recurrent PMDs still remained significantly higher in the SG as compared to CG-2.","['Pregnant patients with previous PMDs', '320 patients with a previous history of normally developing pregnancies and without AT throughout their ongoing pregnancies', 'placenta-mediated diseases in pregnancy', 'patients in the first control group (CG-1) were 150 who also had a previous obstetrical history of PMDs, but did not receive antithrombotic therapy (AT) throughout their ongoing pregnancies', '150 patients to whom either 100\u2009mg of']","['aspirin or low-molecular weight heparin (LMWH', 'antithrombotic therapy', 'antithrombotic therapy (AT']","[""total PMDs' recurrence rate"", 'percentage of recurrent PMDs still', 'recurrent severe PE/total PE ratio', 'overall recurrence rate of PMDs', 'recurrence rate of placenta-mediated diseases (PMDs) such as preeclampsia (PE) and/or intrauterine growth restriction (IUGR), intrauterine fetal death (IUFD), and placental abruption (PA', 'total percentage of PE']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205711', 'cui_str': 'Pelizaeus-Merzbacher disease'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205711', 'cui_str': 'Pelizaeus-Merzbacher disease'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C0015927', 'cui_str': 'Fetal death'}, {'cui': 'C0000832', 'cui_str': 'Placental abruption'}]",320.0,0.0231968,"On the other hand, the percentage of recurrent PMDs still remained significantly higher in the SG as compared to CG-2.","[{'ForeName': 'Konstantsa', 'Initials': 'K', 'LastName': 'Neykova', 'Affiliation': '""Maichin Dom"" State University Hospital, Medical University-Sofia, Sofia, Bulgaria.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Dimitrova', 'Affiliation': '""Maichin Dom"" State University Hospital, Medical University-Sofia, Sofia, Bulgaria.'}, {'ForeName': 'Roumen', 'Initials': 'R', 'LastName': 'Dimitrov', 'Affiliation': '""Maichin Dom"" State University Hospital, Medical University-Sofia, Sofia, Bulgaria.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2020.1757065']
727,32403999,Crossover effects of ultrasound-guided percutaneous neuromodulation on contralateral hamstring flexibility.,"BACKGROUND


Crossover effects refer to the responses of a non-exercised contralateral limb. There is evidence of this effect, as it relates to muscle fatigue, strength, and stretch, but not as it relates to neuromodulation.
OBJECTIVES


To compare the crossover effects of percutaneous neuromodulation (PNM) on hip range of motion (ROM), observed in a straight leg raise (SLR) test, in asymptomatic participants with bilateral reduced hamstring flexibility, versus the neurodynamic sciatic sliding technique, hamstring stretching and mechanical stimulation of the sciatic nerve using a needle (without electrical stimulation). To evaluate the tensiomyographic changes between the two lower limbs after these interventions.
METHODS


80 participants with bilateral reduced hamstring flexibility were randomized into four groups: Stretching, Neurodynamic, PNM, and Needle groups. All interventions were performed on the right limb. Each participant's leg was subjected to SLR testing and tensiomyography before and after the interventions.
RESULTS


Each group improved their SLR values in the non-intervention limb compared to baseline values, but the PNM and Needle groups obtained higher values for the SLR test in the non-intervention limb compared with the Neurodynamic and Stretching groups. There were statistically significant differences for mean SLR measures between limbs pre- and post-intervention for all groups except the PNM group, suggesting crossover effects for PNM but not the other techniques studied. There were no differences in tensiomyographic assessments between groups or between sides, at baseline or upon completion of the study.
CONCLUSION


PNM produced benefits in the SLR test in the non-intervention limb and only 1.5 min was enough to obtain this effect. In addition, no technique interfered with muscle activation.",2020,"There were statistically significant differences for mean SLR measures between limbs pre- and post-intervention for all groups except the PNM group, suggesting crossover effects for PNM but not the other techniques studied.","['80 participants with bilateral reduced hamstring flexibility', 'asymptomatic participants with bilateral reduced hamstring flexibility']","['neurodynamic sciatic sliding technique, hamstring stretching and mechanical stimulation of the sciatic nerve using a needle (without electrical stimulation', 'percutaneous neuromodulation (PNM', 'Stretching, Neurodynamic, PNM, and Needle groups', 'ultrasound-guided percutaneous neuromodulation']","['SLR values', 'hip range of motion (ROM', 'tensiomyographic assessments', 'mean SLR measures', 'contralateral hamstring flexibility']","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C1285354', 'cui_str': 'Mechanical stimulation'}, {'cui': 'C0036394', 'cui_str': 'Structure of sciatic nerve'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0394674', 'cui_str': 'Neurostimulation/modulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0422926', 'cui_str': 'Straight leg raise test response'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",80.0,0.0319151,"There were statistically significant differences for mean SLR measures between limbs pre- and post-intervention for all groups except the PNM group, suggesting crossover effects for PNM but not the other techniques studied.","[{'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'De-la-Cruz-Torres', 'Affiliation': 'Department of Physiotherapy, University of Seville, Avicena street, 41009, Seville, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Carrasco-Iglesias', 'Affiliation': 'Department of Physiotherapy, University of Seville, Avicena street, 41009, Seville, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Minaya-Muñoz', 'Affiliation': 'MVClinic Institute, Madrid, Spain; Department of Physiotherapy, CEU San Pablo University, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Romero-Morales', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Villaviciosa de Odón, 28670, Madrid, Spain.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/0964528420920283']
728,32404001,Economic evaluation alongside a randomised controlled trial to assess the effectiveness and cost-effectiveness of acupuncture in the management of chemotherapy-induced peripheral neuropathy.,"OBJECTIVE


To assess the cost-effectiveness of acupuncture in the management of chemotherapy-induced peripheral neuropathy (CIPN) in Hong Kong.
METHODS


A within trial cost-utility analysis with the primary endpoint for the economic evaluation being the Quality Adjusted Life Year (QALY) and associated Incremental Cost Effectiveness Ratio (ICER) over 14 weeks of treatment. A secondary cost-effectiveness analysis was undertaken with the endpoint being change in pain as measured on the Brief Pain Inventory (BPI).
RESULTS


Eighty-seven patients were randomised to acupuncture or usual care. Acupuncture resulted in significant improvements in pain intensity (8- and 14-week mean changes compared to usual care of -1.8 and -1.8, respectively), pain interference (8- and 14-week mean changes compared to usual care of -1.5 and -0.9, respectively) and indicators of quality of life and neurotoxicity-related symptoms. However, in the economic evaluation there was little difference in QALYs between the two arms (mean change 0.209 and 0.200 in the acupuncture and usual care arms, respectively). Also, costs yielded deterministic ICERs of HK$616,965.62, HK$824,083.44 and HK$540,727.56 per QALY gained from the health care provider perspective, the societal perspective and the patient perspective, respectively. These costs are significantly higher than the cost-effectiveness threshold of HK$180,450 that was used for the base case analysis.
CONCLUSION


While acupuncture can improve symptoms and quality of life indicators related to CIPN, it is unlikely to be a cost-effective treatment for CIPN-related pain in health care systems with limited resources.
TRIAL REGISTRATION NUMBER


NCT02553863 (ClinicalTrials.gov) post-results.",2020,"Acupuncture resulted in significant improvements in pain intensity (8- and 14-week mean changes compared to usual care of -1.8 and -1.8, respectively), pain interference (8- and 14-week mean changes compared to usual care of -1.5 and -0.9, respectively) and indicators of quality of life and neurotoxicity-related symptoms.",['Eighty-seven patients'],"['acupuncture', 'CIPN', 'Acupuncture']","['Brief Pain Inventory (BPI', 'pain intensity', 'Quality Adjusted Life Year (QALY) and associated Incremental Cost Effectiveness Ratio (ICER', 'symptoms and quality of life indicators', 'quality of life and neurotoxicity-related symptoms', 'effectiveness and cost-effectiveness', 'cost-effectiveness', 'pain interference']","[{'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}]",87.0,0.195171,"Acupuncture resulted in significant improvements in pain intensity (8- and 14-week mean changes compared to usual care of -1.8 and -1.8, respectively), pain interference (8- and 14-week mean changes compared to usual care of -1.5 and -0.9, respectively) and indicators of quality of life and neurotoxicity-related symptoms.","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Molassiotis', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong SAR.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Dawkins', 'Affiliation': 'Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Longo', 'Affiliation': 'Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Lorna Kp', 'Initials': 'LK', 'LastName': 'Suen', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong SAR.'}, {'ForeName': 'Hui Lin', 'Initials': 'HL', 'LastName': 'Cheng', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong SAR.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Mok', 'Affiliation': 'Department of Clinical Oncology, Prince of Wales Hospital, Hung Hom, Hong Kong SAR.'}, {'ForeName': 'Claire T', 'Initials': 'CT', 'LastName': 'Hulme', 'Affiliation': 'Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Winnie', 'Initials': 'W', 'LastName': 'Yeo', 'Affiliation': 'Department of Clinical Oncology, Prince of Wales Hospital, Hung Hom, Hong Kong SAR.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/0964528420920285']
729,32404035,Antithrombotic Treatment of Embolic Stroke of Undetermined Source: RE-SPECT ESUS Elderly and Renally Impaired Subgroups.,"Background and Purpose- The RE-SPECT ESUS trial (Randomized, Double-Blind, Evaluation in Secondary Stroke Prevention Comparing the Efficacy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate Versus Acetylsalicylic Acid in Patients With Embolic Stroke of Undetermined Source) tested the hypothesis that dabigatran would be superior to aspirin for the prevention of recurrent stroke in patients with embolic stroke of undetermined source. This exploratory subgroup analysis investigates the impact of age, renal function (both predefined), and dabigatran dose (post hoc) on the rates of recurrent stroke and major bleeding. Methods- RE-SPECT ESUS was a multicenter, randomized, double-blind trial of dabigatran 150 or 110 mg (for patients aged ≥75 years and/or with creatinine clearance 30 to <50 mL/minute) twice daily compared with aspirin 100 mg once daily. The primary outcome was recurrent stroke. Results- The trial, which enrolled 5390 patients from December 2014 to January 2018, did not demonstrate superiority of dabigatran versus aspirin for prevention of recurrent stroke in patients with embolic stroke of undetermined source. However, among the population qualifying for the lower dabigatran dose, the rate of recurrent stroke was reduced with dabigatran versus aspirin (7.4% versus 13.0%; hazard ratio, 0.57 [95% CI, 0.39-0.82]; interaction  P =0.01). This was driven mainly by the subgroup aged ≥75 years (7.8% versus 12.4%; hazard ratio, 0.63 [95% CI, 0.43-0.94]; interaction  P =0.10). Stroke rates tended to be lower with dabigatran versus aspirin with declining renal function. Risks for major bleeding were similar between treatments, irrespective of renal function, but with a trend for lower bleeding rates with dabigatran versus aspirin in older patients. Conclusions- In subgroup analyses of RE-SPECT ESUS, dabigatran reduced the rate of recurrent stroke compared with aspirin in patients qualifying for the lower dose of dabigatran. These results are hypothesis-generating. Aspirin remains the standard antithrombotic treatment for patients with embolic stroke of undetermined source. Registration-URL: https://www.clinicaltrials.gov; Unique identifier: NCT02239120.",2020,"Risks for major bleeding were similar between treatments, irrespective of renal function, but with a trend for lower bleeding rates with dabigatran versus aspirin in older patients.","['patients aged ≥75 years and/or with creatinine clearance 30 to <50 mL/minute) twice daily compared with', 'older patients', 'patients with embolic stroke of undetermined source', 'Patients With Embolic Stroke of Undetermined Source', '5390 patients from December 2014 to January 2018']","['Oral Thrombin Inhibitor Dabigatran Etexilate Versus Acetylsalicylic Acid', 'aspirin 100 mg once daily', 'Methods- RE-SPECT ESUS', 'Aspirin', ' and Purpose', 'dabigatran versus aspirin', 'aspirin', 'Conclusions', 'dabigatran']","['Stroke rates', 'Risks for major bleeding', 'recurrent stroke', 'rates of recurrent stroke and major bleeding', 'rate of recurrent stroke', 'bleeding rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3888970', 'cui_str': 'Embolic stroke of undetermined source'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1571583', 'cui_str': 'dabigatran etexilate'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1124475', 'cui_str': 'Aspirin 100 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",5390.0,0.375563,"Risks for major bleeding were similar between treatments, irrespective of renal function, but with a trend for lower bleeding rates with dabigatran versus aspirin in older patients.","[{'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'From the Faculty of Medicine, Institute for Medical Informatics, Biometry and Epidemiology, University Duisburg-Essen, Germany (H.-C.D.).'}, {'ForeName': 'Ralph L', 'Initials': 'RL', 'LastName': 'Sacco', 'Affiliation': 'Clinical and Translational Science, Miller School of Medicine, University of Miami, FL (R.L.S.).'}, {'ForeName': 'J Donald', 'Initials': 'JD', 'LastName': 'Easton', 'Affiliation': 'Department of Neurology, University of California, San Francisco (J.D.E.).'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (C.B.G.).'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Bar', 'Affiliation': 'Department of Neurology, University Hospital Ostrava, Ostrava-Poruba-Poruba, Czech Republic (M. Bar).'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Bernstein', 'Affiliation': 'Department of Neurology, Northwestern University, Chicago, IL (R.A.B.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Brainin', 'Affiliation': 'Department of Neurosciences and Preventive Medicine, Danube University Krems, Krems an der Donau, Austria (M. Brainin).'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Metabolism Medicine, Boehringer Ingelheim International GmbH, Germany (M. Brueckmann).'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cronin', 'Affiliation': 'Cardiometabolic Medicine, Boehringer Ingelheim Ltd, Burlington, ON, Canada (L.C.).'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Donnan', 'Affiliation': 'Department of Neurology, Melbourne Brain Centre, University of Melbourne, Parkville, VIC, Australia (G.D.).'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Gdovinová', 'Affiliation': 'Department of Neurology, Pavol Jozef Šafárik University in Košice, University Hospital L. Pasteur, Košice, Slovak Republic (Z.G.).'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Grauer', 'Affiliation': 'Clinical Operations Global, Boehringer Ingelheim Pharma GmbH & Co. K.G., Biberach, Germany (C.G.).'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kleine', 'Affiliation': 'Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. K.G., Ingelheim, Germany (E.K.).'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Kleinig', 'Affiliation': 'Department of Neurology, Royal Adelaide Hospital, Adelaide, South Australia, Australia (T.J.K.).'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Lyrer', 'Affiliation': 'Division of Neurology, Stroke Center, University Hospital Basel, Switzerland (P.L.).'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Martins', 'Affiliation': 'Neurology Service, Hospital de Clínicas de Porto Alegre, Brazil (S.M.).'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Meyerhoff', 'Affiliation': 'Cardiology Medicine, Boehringer Ingelheim International GmbH, Germany (J.M.).'}, {'ForeName': 'Truman', 'Initials': 'T', 'LastName': 'Milling', 'Affiliation': 'Department of Neurology, Department of Surgery and Perioperative Care, Seton Dell Medical School Stroke Institute, Austin, TX (T.M.).'}, {'ForeName': 'Waltraud', 'Initials': 'W', 'LastName': 'Pfeilschifter', 'Affiliation': 'Center of Neurology and Neurosurgery, Goethe University Frankfurt, Frankfurt am Main, Germany (W.P.).'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Poli', 'Affiliation': 'Department of Neurology with Focus on Neurovascular Diseases and Neurooncology, University of Tübingen, and Hertie Institute for Clinical Brain Research, Germany (S.P.).'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Reif', 'Affiliation': 'Department of Neurology, Cerebrovaskulární ambulance s.r.o., Brno, Czech Republic (M.R.).'}, {'ForeName': 'David Z', 'Initials': 'DZ', 'LastName': 'Rose', 'Affiliation': 'Department of Neurology, Morsani College of Medicine, University of South Florida, Tampa (D.Z.R.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Šaňák', 'Affiliation': 'Comprehensive Stroke Center, Department of Neurology, Palacky University, Olomouc, Czech Republic (D.S.).'}, {'ForeName': 'Wolf-Rüdiger', 'Initials': 'WR', 'LastName': 'Schäbitz', 'Affiliation': 'Department of Neurology, Evangelisches Klinikum Bethel, Bielefeld, Germany (W.-R.S.).'}]",Stroke,['10.1161/STROKEAHA.119.028643']
730,32404535,Effects of a Virtual Reality Dance Training Program on Kyphosis Angle and Respiratory Parameters in Young Women With Postural Hyperkyphosis: A Randomized Controlled Clinical Trial.,"CONTEXT


Thoracic hyperkyphosis, one of the most common spinal deformities, may lead to undesirable pulmonary outcomes.
OBJECTIVE


To study, the efficacy of virtual reality exercise training on thoracic hyperkyphosis and respiratory parameters in young women.
DESIGN


Randomized clinical trial.
SETTING


Laboratory setting.
PARTICIPANTS AND INTERVENTION


Participants were randomly assigned to one of two 4-week exercise training groups: regular training (RT), which involved stretch and strength training, or virtual reality with RT (VRRT), which involved dance training with the Xbox 360 Kinect® game in addition to the exercises, which the RT group received.
MAIN OUTCOME MEASURES


The authors measured kyphosis angle with a Flexicurve ruler and recorded respiratory parameters (forced vital capacity [FVC] and forced expiratory volume in 1 s [FEV1]) with a spirometer in each participant at baseline and postintervention. Separate 2 × 2 repeated-measure analysis of variances were used to analyze differences between means for kyphosis angle, FEV1, and FVC. Based on the significant interactions between time and group, the paired t test was used to compare the results at baseline and postintervention, and the independent sample t test was used to compare the differences in changes between groups. Level of significance was considered at P < .05 except for paired t test that was adjusted to P < .025 for each variable in 2 groups.
RESULTS


The results showed statistically significant interactions between time and group for kyphosis angle, FEV1, and FVC. Postintervention thoracic kyphosis angle decreased and FVC increased significantly in both groups and FEV1 improved significantly in virtual reality with RT group. The improvements in thoracic kyphosis, FVC, and FEV1 in the virtual reality with RT group were significantly greater (P < .001) than in the RT group.
CONCLUSION


Dance training with the Xbox 360 Kinect game was an effective therapy in improving thoracic kyphosis angle, FVC, and FEV1 in young women with thoracic hyperkyphosis.",2020,Postintervention thoracic kyphosis angle decreased and FVC increased significantly in both groups and FEV1 improved significantly in virtual reality with RT group.,"['Young Women With Postural Hyperkyphosis', 'young women', 'young women with thoracic hyperkyphosis']","['exercise training groups: regular training (RT), which involved stretch and strength training, or virtual reality with RT (VRRT), which involved dance training with the Xbox 360 Kinect® game in addition to the exercises, which the RT group received', 'virtual reality exercise training', 'Virtual Reality Dance Training Program']","['kyphosis angle with a Flexicurve ruler and recorded respiratory parameters (forced vital capacity [FVC] and forced expiratory volume in 1\xa0s [FEV1', 'thoracic kyphosis angle, FVC, and FEV1', 'Kyphosis Angle and Respiratory Parameters', 'kyphosis angle, FEV1, and FVC', 'thoracic kyphosis, FVC, and FEV1 in the virtual reality', 'FVC', 'thoracic hyperkyphosis and respiratory parameters']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]",,0.0422235,Postintervention thoracic kyphosis angle decreased and FVC increased significantly in both groups and FEV1 improved significantly in virtual reality with RT group.,"[{'ForeName': 'Sahba', 'Initials': 'S', 'LastName': 'Taslimipour', 'Affiliation': ''}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Rojhani-Shirazi', 'Affiliation': ''}, {'ForeName': 'Ladan', 'Initials': 'L', 'LastName': 'Hemmati', 'Affiliation': ''}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Rezaei', 'Affiliation': ''}]",Journal of sport rehabilitation,['10.1123/jsr.2019-0303']
731,32404539,Counteracting effect of verbal ratings of sleepiness on dual task interference.,"The aim of the present study was to demonstrate the effect of verbal ratings on arousal in the electroencephalogram (EEG) and psychomotor vigilance test (PVT) performance. Thirty participants underwent the PVT for 40 min in three experimental conditions: (1) Rating condition, in which they verbally rated subjective sleepiness with Karolinska sleepiness scale, following pure tone sound played every 20 s during PVT, (2) No-rating condition, in which they underwent PVT with the similar sound as the Rating experiment but without the verbal rating task, and (3) Control condition, in which they underwent PVT with a no-sound stimulus and without the verbal rating task. The results show that during the first half of the task epoch, alpha power density was lower in the Rating than in the No-rating condition, while performance was not different between the conditions. During the second half of the task epoch, performance was better in the Non-rating than in the Rating condition, but no difference in the alpha power density. These results suggest that performance deterioration could be masked by the arousal effect of the dual task itself. It could also explain why the PVT performance and arousal in EEG sometimes dissociate, particularly in dual task situations.",2020,"During the second half of the task epoch, performance was better in the Non-rating than in the Rating condition, but no difference in the alpha power density.",['Thirty participants underwent the'],"['pure tone sound played every 20 s during PVT, (2) No-rating condition, in which they underwent PVT with the similar sound as the Rating experiment but without the verbal rating task, and (3) Control condition, in which they underwent PVT with a no-sound stimulus and without the verbal rating task', 'PVT']","['alpha power density', 'verbal ratings on arousal in the electroencephalogram (EEG) and psychomotor vigilance test (PVT) performance', 'verbal ratings of sleepiness on dual task interference']","[{'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332288', 'cui_str': 'Without'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}]",30.0,0.0278604,"During the second half of the task epoch, performance was better in the Non-rating than in the Rating condition, but no difference in the alpha power density.","[{'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Kaida', 'Affiliation': 'Human Informatics and Interaction Research Institute, National Institute of Advanced Industrial Science and Technology (AIST), Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'International Institute for Integrative Sleep Medicine (WPI-IIIS), University of Tsukuba, Japan.'}, {'ForeName': 'Sunao', 'Initials': 'S', 'LastName': 'Iwaki', 'Affiliation': 'Human Informatics and Interaction Research Institute, National Institute of Advanced Industrial Science and Technology (AIST), Japan.'}]",Industrial health,['10.2486/indhealth.2020-0005']
732,32404599,Effect of blood insulin level on postprandial hypotension in elderly people.,"OBJECTIVES


The aim of the study is to discuss the effect of postprandial insulin level on blood pressure in elderly patients by comparing the blood pressure, blood glucose, and insulin levels between patients with postprandial hypotension (PPH) and non-PPH over 80 years old during fasting and within 2 h after meal, and observing the changes of parameters in patients with PPH before and after treatment with acarbose.
METHODS AND MATERIALS


Twenty-five PPH patients and 27 non-PPH patients were selected. The blood pressure, blood glucose, and insulin levels during fasting and within 2 h after meal were monitored. Patients with PPH were treated with acarbose. All parameters were checked one week later.
RESULTS


(1) Preprandial blood pressure in PPH group was significantly higher than that in non-PPH group (152.00 ± 15.62 mmHg vs. 136.40 ± 14.12 mmHg, P < 0.05). (2) The maximum decrease of postprandial systolic blood pressure (SBP) in PPH group was significantly increased compared with that of the control group (32.20 ± 13.19 mmHg vs. 9.67 ± 8.38 mmHg, P < 0.05). The maximum increases of postprandial blood glucose and insulin levels were significantly higher in PPH group than in the control group (P < 0.05). (3) After acarbose treatment, the decrease of postprandial SBP in PPH group was significantly reduced compared with that before treatment (22.67 ± 6.98 mmHg vs. 32.60 ± 9.55 mmHg, P < 0.05); the increase of postprandial blood glucose was also significantly reduced in PPH group (2.37 ± 1.63 mmol/L vs. 3.39 ± 1.62 mmol/L, P < 0.05); the increase of postprandial insulin level was reduced significantly in PPH group (12.09 ± 3.96 mU/L vs. 22.33 ± 1.78 mU/L, P < 0.05). (4) There was no correlation between the maximum decrease of postprandial SBP and the maximum increase of blood glucose (r = -0.008, P = 0.961), but the maximum decrease of postprandial SBP was positively correlated with the maximum increase of insulin (r = 0.381, P = 0.032).
CONCLUSION


PPH tends to occur in elderly people with elevated basal blood pressure before meal. PPH is associated with an abnormal increase of postprandial insulin secretion. Reducing the increase of postprandial insulin is one of the mechanisms of acarbose in the treatment of PPH.",2020,The maximum increases of postprandial blood glucose and insulin levels were significantly higher in PPH group than in the control group (P < 0.05).,"['elderly people with elevated basal blood pressure before meal', 'patients with postprandial hypotension (PPH) and non-PPH over 80\u2009years old during fasting and within 2\u2009h after meal, and observing the changes of parameters in patients with PPH before and after treatment with', 'Twenty-five PPH patients and 27 non-PPH patients were selected', 'Patients with PPH', 'elderly people', 'elderly patients']","['blood insulin level', 'PPH', 'postprandial insulin level', 'acarbose']","['postprandial insulin', 'postprandial hypotension', 'blood pressure', 'postprandial insulin level', 'blood glucose', 'Preprandial blood pressure', 'postprandial systolic blood pressure (SBP', 'postprandial blood glucose', 'postprandial blood glucose and insulin levels', 'postprandial SBP', 'blood pressure, blood glucose, and insulin levels', 'postprandial insulin secretion']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1550738', 'cui_str': 'Before food'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C3715062', 'cui_str': '25'}]","[{'cui': 'C0853230', 'cui_str': 'Blood insulin'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1550738', 'cui_str': 'Before food'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}]",25.0,0.0150893,The maximum increases of postprandial blood glucose and insulin levels were significantly higher in PPH group than in the control group (P < 0.05).,"[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'The Six Department of Cardiac Surgery, Beijing An Zhen Hospital, Capital Medical University.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Qiao', 'Affiliation': 'The Second Department of Health Care, China-Japan Friendship Hospital, Beijng, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The Second Department of Health Care, China-Japan Friendship Hospital, Beijng, China.'}, {'ForeName': 'Yunyun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'The Second Department of Health Care, China-Japan Friendship Hospital, Beijng, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The Second Department of Health Care, China-Japan Friendship Hospital, Beijng, China.'}, {'ForeName': 'Kejing', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'The Second Department of Health Care, China-Japan Friendship Hospital, Beijng, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'The Second Department of Health Care, China-Japan Friendship Hospital, Beijng, China.'}]",Blood pressure monitoring,['10.1097/MBP.0000000000000450']
733,32404646,Comparison of Lutetium-177 tin colloid and Rhenium-188 tin colloid radiosynovectomy in chronic knee arthritis.,"OBJECTIVE


To assess the role of Lutetium-177(Lu-177) tin colloid for radiosynovectomy and compare it with Rhenium-188 (Re-188) tin colloid radiosynovectomy for alleviation of pain in patients with chronic inflammatory arthritis of knee.
METHODS


Patients of chronic inflammatory arthritis of the knee underwent pretherapeutic evaluation in a form of knee ultrasonogram, bone scan and clinical evaluation. Fifty-seven recruited patients were allocated at random to receive either intraarticular injections of Lu-177 tin colloid or Re-188 tin colloid. Eventually, 27 patients received Re-188 tin colloid and 30 patients received Lu-177 tin colloid. The joint was then immobilized for 2 days. Response evaluation was done using knee ultrasound, bone scan and clinical findings.
RESULT


Of 30, 20 patients responded to radiosynovectomy in the Lu-177 tin colloid group compared to 21/27 patients in the Re-188 tin colloid group.
CONCLUSION


Lu-177 tin colloid is an effective alternative to Re-188 tin colloid for radiosynovectomy in patients with chronic inflammatory knee arthritis.",2020,"CONCLUSION


Lu-177 tin colloid is an effective alternative to Re-188 tin colloid for radiosynovectomy in patients with chronic inflammatory knee arthritis.","['patients with chronic inflammatory knee arthritis', 'Patients of chronic inflammatory arthritis of the knee underwent pretherapeutic evaluation in a form of knee ultrasonogram, bone scan and clinical evaluation', 'Fifty-seven recruited patients', '27 patients received', 'chronic knee arthritis', 'patients with chronic inflammatory arthritis of knee']","['Rhenium-188 (Re-188) tin colloid radiosynovectomy', 'Lutetium-177 tin colloid and Rhenium-188 tin colloid radiosynovectomy', 'intraarticular injections of Lu-177 tin colloid or Re-188 tin colloid', 'Lu-177 tin colloid', 'Lutetium-177(Lu-177) tin colloid for radiosynovectomy', 'Re-188 tin colloid', 'Re-188 tin colloid group']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0240111', 'cui_str': 'Arthritis of knee'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0427251', 'cui_str': 'Form of knee'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0203668', 'cui_str': 'Radioisotope scan of bone'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C4517815', 'cui_str': '57'}]","[{'cui': 'C1828331', 'cui_str': 'Rhenium-188'}, {'cui': 'C0040238', 'cui_str': 'Tin'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}, {'cui': 'C2959378', 'cui_str': 'Lutetium-177'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C0024170', 'cui_str': 'Lutetium'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],57.0,0.046298,"CONCLUSION


Lu-177 tin colloid is an effective alternative to Re-188 tin colloid for radiosynovectomy in patients with chronic inflammatory knee arthritis.","[{'ForeName': 'Shamim Ahmed', 'Initials': 'SA', 'LastName': 'Shamim', 'Affiliation': 'Departments of Nuclear Medicine.'}, {'ForeName': 'Geetanjali', 'Initials': 'G', 'LastName': 'Arora', 'Affiliation': 'Departments of Nuclear Medicine.'}, {'ForeName': 'Pragati', 'Initials': 'P', 'LastName': 'Jha', 'Affiliation': 'Departments of Nuclear Medicine.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Departments of Nuclear Medicine.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Behera', 'Affiliation': 'Departments of Nuclear Medicine.'}, {'ForeName': 'Anirban', 'Initials': 'A', 'LastName': 'Mukherjee', 'Affiliation': 'Departments of Nuclear Medicine.'}, {'ForeName': 'Meghna', 'Initials': 'M', 'LastName': 'Prabhu', 'Affiliation': 'Departments of Nuclear Medicine.'}, {'ForeName': 'Mohammad Tahir', 'Initials': 'MT', 'LastName': 'Ansari', 'Affiliation': 'Orthopedics.'}, {'ForeName': 'Surabhi', 'Initials': 'S', 'LastName': 'Vyas', 'Affiliation': 'Radiodiagnosis, AIIMS, New Delhi, India.'}, {'ForeName': 'Chandrasekhar', 'Initials': 'C', 'LastName': 'Bal', 'Affiliation': 'Departments of Nuclear Medicine.'}]",Nuclear medicine communications,['10.1097/MNM.0000000000001210']
734,32405550,A Prospective Randomized Double-blind study of silicone gel plus Herbal Extracts Versus Placebo in Pre-sternal hypertrophic scar prevention and amelioration.,"Objective


Post-surgical hypertrophic scar is more frequently reported in Asians. Many modalities can treat scars but there have not been any publications to define the efficacy of silicone gel plus herbal extracts for scar prevention or amelioration.
Design


48 patients, who underwent median sternotomy were randomized and double-blinded to 2 groups to use topical silicone gel plus herbal extract gel or placebo for 6 months. Patients were treated either with topical silicone gel plus herbal extract gel or control using only placebo for 6 months. The scars were observed by experienced plastic surgeons using the Vancouver scar scale.
Setting


A single tertiary care center at Khon Kaen University.
Paticipants


48 patients who underwent median sternotomy were enrolled in this study. All patients were aged over 18 years. All the wounds were sutured with polyglycolic 4/0 subcuticular suture material and did not receive other scar management before participating in this study.
Intervention


The silicone gel plus herbal extract gel (Bangkok Botanica, Bangkok, Thailand) in semi-liquid form was formulated from 15% Herbal extract (Allium Cepa extract, Centella Asiatica extract, Aloe Vera extract and Paper Mulberry extract), 50% polydemethysiloxane, 30% cyclopentasiloxane and 5% silica. The placebo gel was a composite of water, acrylate, C10-30 alkyl acrylate cross-polymer, polysorbate 20 and fragrance that was similar in color and consistency as that of the active gel and packed in the similar sealed packages.
Main outcome measures


The scar was assessed using the Vancouver scar scale to determine pigmentation, vascularity, pliability and height.
Results


the study showed the silicone gel plus herbal extract gel could improve scar amelioration in height (p = 0.005) and pliability (p < 0.001) when compared to the placebo. The vascularity and pigmentation showed improvement using silicone gel plus herbal extracts but the improvement was not statistically significant.
Conclusion


The silicone gel plus herbal extracts gel was effective for scar improvement in median sternotomy wounds.",2020,the study showed the silicone gel plus herbal extract gel could improve scar amelioration in height (p = 0.005) and pliability (p < 0.001) when compared to the placebo.,"['Pre-sternal hypertrophic scar prevention and amelioration', 'Setting\n\n\nA single tertiary care center at Khon Kaen University', '48 patients who underwent median sternotomy', '48 patients, who underwent median sternotomy', 'All patients were aged over 18 years']","['silicone gel plus herbal extracts', 'silicone gel plus herbal extract gel (Bangkok Botanica, Bangkok, Thailand) in semi-liquid form was formulated from 15% Herbal extract (Allium Cepa extract, Centella Asiatica extract, Aloe Vera extract and Paper Mulberry extract), 50% polydemethysiloxane, 30% cyclopentasiloxane and 5% silica', 'polyglycolic 4/0 subcuticular suture material and did not receive other scar management', 'topical silicone gel plus herbal extract gel or placebo', 'placebo gel', 'silicone gel plus Herbal Extracts Versus Placebo', 'silicone gel plus herbal extract gel', 'silicone gel plus herbal extracts gel', 'topical silicone gel plus herbal extract gel or control using only placebo', 'placebo']","['Vancouver scar scale to determine pigmentation, vascularity, pliability and height', 'scar amelioration in height', 'scar improvement', 'pliability']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0162810', 'cui_str': 'Hypertrophic scar'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1282959', 'cui_str': 'Median sternotomy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0599034', 'cui_str': 'Silicone Gels'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0444833', 'cui_str': 'Botanica'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0949117', 'cui_str': 'Onion extract'}, {'cui': 'C2948088', 'cui_str': 'Centella asiatica extract'}, {'cui': 'C0995182', 'cui_str': 'Aloe vera preparation'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0330540', 'cui_str': 'Morus'}, {'cui': 'C0037098', 'cui_str': 'Silicon Dioxide'}, {'cui': 'C0563304', 'cui_str': 'Subcuticular'}, {'cui': 'C0038969', 'cui_str': 'Surgical suture'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0556498', 'cui_str': 'Scar management'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]",,0.109865,the study showed the silicone gel plus herbal extract gel could improve scar amelioration in height (p = 0.005) and pliability (p < 0.001) when compared to the placebo.,"[{'ForeName': 'Palakorn', 'Initials': 'P', 'LastName': 'Surakunprapha', 'Affiliation': 'Plastic & Reconstructive Unit, Department of Surgery, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Kengkart', 'Initials': 'K', 'LastName': 'Winaikosol', 'Affiliation': 'Plastic & Reconstructive Unit, Department of Surgery, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Bowornsilp', 'Initials': 'B', 'LastName': 'Chowchuen', 'Affiliation': 'Plastic & Reconstructive Unit, Department of Surgery, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Puttama', 'Initials': 'P', 'LastName': 'Punyavong', 'Affiliation': 'Plastic & Reconstructive Unit, Department of Surgery, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Kriangsak', 'Initials': 'K', 'LastName': 'Jenwitheesuk', 'Affiliation': 'General Surgery Unit, Department of Surgery, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Kamonwan', 'Initials': 'K', 'LastName': 'Jenwitheesuk', 'Affiliation': 'Plastic & Reconstructive Unit, Department of Surgery, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}]",Heliyon,['10.1016/j.heliyon.2020.e03883']
735,32405570,"Protocol and recruitment results from a 13-week randomized controlled trial comparing the effects of different doses of nitrate-rich beetroot juice on cognition, cerebral blood flow and peripheral vascular function in overweight and obese older people.","Background


Nitrate-rich food can increase NO production and may induce positive effects on brain function. This study examined the feasibility of a randomized clinical trial (RCT) testing the effects of prolonged consumption of incremental doses of dietary nitrate (NO 3   - ) in overweight and obese older participants. Secondary aims tested dose-dependent changes in cognitive, vascular and pulmonary functions and cerebral blood flow (CBF).
Methods


This was a single blind, four-arm parallel RCT conducted in 60 overweight and obese older participants. Eligible participants were randomized to:1) high NO 3   -  (140 ml of beetroot juice (BJ) per day, ~800 mg of NO 3   - /day), 2) moderate NO 3   -  (70 ml of BJ per day, ~400 mg of NO 3   - /day), 3) low NO 3   -  (70 ml on alternate days, ~400 mg of NO 3   - ) or 4) NO 3   -  depleted (70 ml on alternate days, ~0.001 mg of NO 3 ). Measurements of cognitive, vascular and pulmonary functions and CBF were conducted at baseline and 13-weeks NO 3   -  intake was assessed by six 24-h recalls, and by measuring NO 3   -  intake biomarkers. Feasibility was assessed by obtaining qualitative feedback and evaluating trial recruitment, retention, compliance with study visits and measurement protocols.
Results


Participant recruitment started in July 2018 and ended in April 2019. Of all the recruitment strategies that were used, advertisement of the study via Facebook generated the highest response rate. Sixty-two participants consented and were enrolled. Overall, characteristics of included participants matched our recruitment criteria.
Conclusion


The findings from this study provide evidence of the acceptability and feasibility of an intervention investigating the effects of incremental doses of high-nitrate BJ over a prolonged period.
Trial registration


The intervention study was registered with clinical trial ISRCTN registry (ISRCTN14746723) on 27 December 2018.",2020,"Of all the recruitment strategies that were used, advertisement of the study via Facebook generated the highest response rate.","['overweight and obese older people', '60 overweight and obese older participants', 'Sixty-two participants consented and were enrolled', 'overweight and obese older participants', 'Eligible participants were randomized', '400']","['high-nitrate BJ', 'dietary nitrate (NO 3   - ', 'nitrate-rich beetroot juice']","['cognitive, vascular and pulmonary functions and cerebral blood flow (CBF', 'Measurements of cognitive, vascular and pulmonary functions and CBF', 'cognition, cerebral blood flow and peripheral vascular function']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}]",60.0,0.250717,"Of all the recruitment strategies that were used, advertisement of the study via Facebook generated the highest response rate.","[{'ForeName': 'Abrar M', 'Initials': 'AM', 'LastName': 'Babateen', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Leech Building, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Rubele', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Leech Building, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Shannon', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Leech Building, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Okello', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Leech Building, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Smith', 'Affiliation': 'Brain Performance and Nutrition Research Centre, Northumbria University, Newcastle Upon-Tyne, NE1 8ST, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'McMahon', 'Affiliation': 'School of Human Movement and Nutrition Sciences, University of Queensland, St. Lucia, QLD, Australia.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': ""O'Brien"", 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Leech Building, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Wightman', 'Affiliation': 'Brain Performance and Nutrition Research Centre, Northumbria University, Newcastle Upon-Tyne, NE1 8ST, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kennedy', 'Affiliation': 'Brain Performance and Nutrition Research Centre, Northumbria University, Newcastle Upon-Tyne, NE1 8ST, UK.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Mathers', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Leech Building, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Siervo', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Leech Building, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100571']
736,32405581,Randomized Controlled Trial of Difelikefalin for Chronic Pruritus in Hemodialysis Patients.,"Introduction


There is an unmet medical need for pruritus associated with chronic kidney disease, a distressing complication characterized by generalized and persistent itch affecting 20% to 40% of patients undergoing hemodialysis. Here we report the results of a phase 2 trial evaluating the efficacy and safety of a novel peripherally restricted kappa opioid receptor agonist, difelikefalin, in adult patients undergoing hemodialysis with pruritus.
Methods


In this study, 174 hemodialysis patients with moderate-to-severe pruritus were randomly assigned to receive difelikefalin (0.5, 1.0, or 1.5 μg/kg) or placebo intravenously thrice weekly after each hemodialysis session for 8 weeks in a double-blind, controlled trial. The primary endpoint was the change from baseline at week 8 in the weekly mean of the 24-hour Worst Itching Intensity Numerical Rating Scale score. The secondary efficacy endpoint was the change in itch-related quality of life measured by the Skindex-10 questionnaire. Other endpoints included safety, sleep quality, and additional measures including the 5-D itch scale.
Results


A significant reduction from baseline in itch intensity scores at week 8 favored all difelikefalin doses combined versus placebo ( P  = 0.002). Difelikefalin also showed improvement over placebo in Skindex-10, 5-D itch, and sleep disturbance scores ( P  ≤ 0.005). Overall, 78% of patients receiving difelikefalin reported treatment-emergent adverse events versus 42% of patients given placebo, with diarrhea, dizziness, nausea, somnolence, and fall being the most frequent (≥5%).
Conclusion


In this trial, difelikefalin effectively reduced itching intensity and improved sleep and itch-related quality of life.",2020,"In this trial, difelikefalin effectively reduced itching intensity and improved sleep and itch-related quality of life.","['Chronic Pruritus in Hemodialysis Patients', '174 hemodialysis patients with moderate-to-severe pruritus', 'adult patients undergoing hemodialysis with pruritus']","['novel peripherally restricted kappa opioid receptor agonist, difelikefalin', 'difelikefalin', 'Difelikefalin', 'placebo']","['treatment-emergent adverse events', 'change in itch-related quality of life measured by the Skindex-10 questionnaire', 'efficacy and safety', '24-hour Worst Itching Intensity Numerical Rating Scale score', 'itch intensity scores', 'diarrhea, dizziness, nausea, somnolence', 'Skindex-10, 5-D itch, and sleep disturbance scores', 'safety, sleep quality, and additional measures including the 5-D itch scale', 'itching intensity and improved sleep and itch-related quality of life']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0064239', 'cui_str': 'kappa Opioid Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",174.0,0.3552,"In this trial, difelikefalin effectively reduced itching intensity and improved sleep and itch-related quality of life.","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Fishbane', 'Affiliation': 'Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York, USA.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Mathur', 'Affiliation': 'MathurConsulting, Woodside, California, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Germain', 'Affiliation': 'Baystate Medical Center and Tufts University, Springfield, Massachusetts, USA.'}, {'ForeName': 'Shayan', 'Initials': 'S', 'LastName': 'Shirazian', 'Affiliation': 'Columbia University Medical Center, Division of Nephrology, Department of Medicine, College of Physicians and Surgeons at Columbia University, New York, New York, USA.'}, {'ForeName': 'Sarbani', 'Initials': 'S', 'LastName': 'Bhaduri', 'Affiliation': 'Bhaduri Biotech Consulting, El Paso, Texas, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Munera', 'Affiliation': 'Cara Therapeutics, Inc., Stamford, Connecticut, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Spencer', 'Affiliation': 'Cara Therapeutics, Inc., Stamford, Connecticut, USA.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Menzaghi', 'Affiliation': 'Cara Therapeutics, Inc., Stamford, Connecticut, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Kidney international reports,['10.1016/j.ekir.2020.01.006']
737,32405623,"Efficacy and safety of ascending dosages of albendazole against  Trichuris trichiura  in preschool-aged children, school-aged children and adults: A multi-cohort randomized controlled trial.","Background


The efficacy of the widely used albendazole against the soil-transmitted helminth  Trichuris trichiura  is limited; yet optimal doses, which may provide increased efficacy, have not been thoroughly investigated to date.
Methods


A randomized-controlled trial was conducted in Côte d'Ivoire with preschool-aged children (PSAC), school-aged children (SAC), and adults infected with  T. trichiura . Participants were randomly assigned (1:1:1:1) using computer-generated randomization. PSAC were randomized to 200 mg, 400 mg, 600 mg of albendazole or placebo. SAC and adults were randomized to 400 mg, 600 mg, 800 mg of albendazole or placebo. The primary outcome was cure rates (CRs) against trichuriasis. Secondary outcomes were  T. trichiura  egg reduction rates (ERRs), safety, CRs and ERRs against other soil-transmitted helminths. Outcome assessors and the trial statistician were blinded. Trial registration at ClinicalTrial.gov: NCT03527745.
Findings


111 PSAC, 180 SAC, and 42 adults were randomized and 86, 172, and 35 provided follow-up stool samples, respectively. The highest observed CR among PSAC was 27·8% (95% CI: 9·7%-53·5%) in the 600 mg albendazole treatment arm. The most efficacious arm for SAC was 600 mg of albendazole showing a CR of 25·6% (95% CI: 13·5%-41·2%), and for adults it was 400 mg of albendazole with a CR of 55·6% (95% CI: 21·2%-86·3%). CRs and ERRs did not differ significantly among treatment arms and flat dose-responses were observed. 17·9% and 0·4% of participants reported any adverse event at 3 and 24 h follow-up, respectively.
Interpretation


Albendazole shows low efficacy against  T. trichiura  in all populations and doses studied, though findings for PSAC and adults should be carefully interpreted as recruitment targets were not met. New drugs, treatment regimens, and combinations are needed in the management of  T. trichiura  infections.
Funding


Bill and Melinda Gates Foundation.",2020,"17·9% and 0·4% of participants reported any adverse event at 3 and 24 h follow-up, respectively.
","[""Côte d'Ivoire with preschool-aged children (PSAC), school-aged children (SAC), and adults infected with  T. trichiura "", 'Findings\n\n\n111 PSAC, 180 SAC, and 42 adults were randomized and 86, 172, and 35 provided follow-up stool samples, respectively', 'preschool-aged children, school-aged children and adults']","['albendazole or placebo', 'albendazole', 'Albendazole']","['CRs and ERRs', 'Efficacy and safety', 'adverse event', 'T. trichiura  egg reduction rates (ERRs), safety, CRs and ERRs against other soil-transmitted helminths', 'cure rates (CRs) against trichuriasis']","[{'cui': 'C0022326', 'cui_str': 'Ivory Coast'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1550661', 'cui_str': 'Stool specimen'}]","[{'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0037592', 'cui_str': 'Soil'}, {'cui': 'C0242781', 'cui_str': 'Communicable Disease Transmission'}, {'cui': 'C0018893', 'cui_str': 'Helminth'}, {'cui': 'C0040954', 'cui_str': 'Infection by Trichuris trichiura'}]",,0.631486,"17·9% and 0·4% of participants reported any adverse event at 3 and 24 h follow-up, respectively.
","[{'ForeName': 'Chandni', 'Initials': 'C', 'LastName': 'Patel', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Jean T', 'Initials': 'JT', 'LastName': 'Coulibaly', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Jessica D', 'Initials': 'JD', 'LastName': 'Schulz', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': ""N'Gbesso"", 'Affiliation': ""Department de Agboville, Centre de Santé Urbain d'Azaguié, Côte d'Ivoire.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hattendorf', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Keiser', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100335']
738,32205226,Lusutrombopag Is Safe and Efficacious for Treatment of Thrombocytopenia in Patients With and Without Hepatocellular Carcinoma.,"BACKGROUND & AIMS


Patients with hepatocellular carcinoma (HCC) secondary to chronic liver disease often require invasive procedures but frequently have thrombocytopenia. Lusutrombopag is an agonist of the thrombopoietin receptor that activates platelet production.
METHODS


We performed an integrated analysis of data from 2 phase 3 trials (L-PLUS 1, Japan, October 2013 to May 2014, and L-PLUS 2, global, June 2015 to April 2017) that compared the efficacy and safety of lusutrombopag with placebo in patients with chronic liver disease, with and without HCC. Our analysis included patients with ECOG grades of 0 or 1, Child-Pugh classes A or B, and a platelet count less than 50 × 10 9 /L who were scheduled to undergo invasive procedures in 9 to 14 days. Patients received lusutrombopag (3 mg) or placebo daily for 7 days or fewer before an invasive procedure. Imaging studies assessed treatment-emergent adverse events, including asymptomatic portal vein thrombosis. The primary end point was no requirement for platelet transfusion before the invasive procedure or rescue therapies for bleeding 7 days or fewer after the invasive procedure.
RESULTS


The per-protocol population included 270 patients (95 with HCC). A significantly higher proportion of patients with HCC who received lusutrombopag achieved the primary end point (68.0%) vs patients who received placebo (8.9%) (P < .0001); in patients without HCC, these proportions were 77.0% vs 21.6% (P < .0001). Lusutrombopag reduced the need for platelet transfusions, increased platelet counts for 3 weeks, and reduced the number of bleeding events in patients with and without HCC compared with placebo. Risk of thrombosis was similar to that of placebo.
CONCLUSIONS


Patients with and without HCC receiving lusutrombopag had a reduction in the number of platelet transfusions before invasive procedures compared with patients receiving placebo, with no increase in thrombosis or bleeding. L-PLUS 1: JapicCTI-132323; L-PLUS 2: ClinicalTrials.gov number no: NCT02389621.",2020,"The primary endpoint was no requirement for platelet transfusion before the invasive procedure or rescue therapies for bleeding 7 days or less after the invasive procedure.
","['patients with chronic liver disease, with and without HCC', '270 patients (95 with HCC', 'patients with ECOG grades of 0 or 1, Child', 'Patients with hepatocellular carcinoma (HCC', 'Patients With and Without Hepatocellular Carcinoma']","['placebo', 'lusutrombopag (3 mg) or placebo', 'Lusutrombopag', 'lusutrombopag to placebo']","['Risk of thrombosis', 'number of bleeding events', 'number of platelet transfusions', 'platelet counts', 'platelet transfusion', 'thrombosis or bleeding', 'asymptomatic portal vein thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease (disorder)'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0430797', 'cui_str': 'Intracranial EEG'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4309207', 'cui_str': 'lusutrombopag'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0155773', 'cui_str': 'Portal vein thrombosis (disorder)'}]",,0.350149,"The primary endpoint was no requirement for platelet transfusion before the invasive procedure or rescue therapies for bleeding 7 days or less after the invasive procedure.
","[{'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Alkhouri', 'Affiliation': 'Department of Metabolic Center, Texas Liver Institute, San Antonio, Texas. Electronic address: alkhouri@txliver.com.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Imawari', 'Affiliation': 'Institute for Gastrointestinal and Liver Disease, Shin-Yurigaoka General Hospital, Kawasaki, Japan.'}, {'ForeName': 'Namiki', 'Initials': 'N', 'LastName': 'Izumi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Osaki', 'Affiliation': 'Meiwa Hospital, Nishinomiya, Japan.'}, {'ForeName': 'Toshimitsu', 'Initials': 'T', 'LastName': 'Ochiai', 'Affiliation': 'Biostatistics Center, Shionogi & Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kano', 'Affiliation': 'Global Project Management Department, Shionogi & Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Bentley', 'Affiliation': 'Global Market Access, Shionogi, Inc, Florham Park, New Jersey.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Trevisani', 'Affiliation': 'Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.03.032']
739,32057960,"Effects of ruxolitinib cream on pruritus and quality of life in atopic dermatitis: Results from a phase 2, randomized, dose-ranging, vehicle- and active-controlled study.","BACKGROUND


Atopic dermatitis (AD), a chronic, highly pruritic skin disorder, impairs quality of life (QoL). Janus kinase inhibitors suppress inflammatory and pruritus-associated cytokine signaling in AD.
OBJECTIVE


To report the effects of ruxolitinib (RUX) cream on itch and QoL in AD.
METHODS


A total of 307 adult patients with an Investigator's Global Assessment (score of 2 or 3) and 3% to 20% affected body surface area were randomly assigned for 8 weeks to receive double-blind treatment with RUX (1.5% twice daily, 1.5% once daily, 0.5% once daily, or 0.15% once daily), vehicle twice daily, or triamcinolone cream (0.1% twice daily for 4 weeks then vehicle for 4 weeks). Itch was measured by using the numerical rating scale, and patient QoL was assessed with Skindex-16.
RESULTS


Improvements in itch numerical rating scale and Skindex-16 were observed with RUX cream. Overall, 42.5% of patients who applied 1.5% RUX twice daily experienced minimal clinically important difference in itch within 36 hours of treatment (vehicle, 13.6%; P < .01); near-maximal improvement was observed by week 4. Itch reduction was associated with improved QoL burden (Pearson correlation, 0.67; P < .001). Significant improvements in Skindex-16 overall scores were noted at week 2.
LIMITATIONS


Facial AD lesions were not treated.
CONCLUSION


RUX cream provides a clinically meaningful reduction in itch and QoL burden.",2020,"Itch reduction was associated with improved QoL burden (Pearson correlation, 0.67; P<0.001).","['Atopic Dermatitis', ""307 adult patients with an Investigator's Global Assessment (IGA) score of 2 or 3 and 3%‒20% affected body surface area""]","['ruxolitinib (RUX) cream', 'triamcinolone cream', 'Ruxolitinib Cream', 'RUX cream', 'RUX']","['Skindex-16 overall scores', 'Pruritus and Quality of Life', 'QoL burden', 'numerical rating scale (NRS); patient QoL']","[{'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}]","[{'cui': 'C2931926', 'cui_str': 'ruxolitinib'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0034380'}, {'cui': 'C0222045'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",307.0,0.171922,"Itch reduction was associated with improved QoL burden (Pearson correlation, 0.67; P<0.001).","[{'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': 'Center for the Study of Itch and Sensory Disorders, Washington University School of Medicine, St Louis, Missouri. Electronic address: briankim@wustl.edu.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Sun', 'Affiliation': 'Incyte Corporation, Wilmington, Delaware.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'K. Papp Clinical Research and Probity Medical Research, Waterloo, Ontario, Canada.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Venturanza', 'Affiliation': 'Incyte Corporation, Wilmington, Delaware.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Nasir', 'Affiliation': 'Wake Research Associates LLC, Raleigh, North Carolina.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Kuligowski', 'Affiliation': 'Incyte Corporation, Wilmington, Delaware.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.02.009']
740,31520258,Auricular acupuncture as effective pain relief after episiotomy: a randomized controlled pilot study.,"PURPOSE


Previously, pain treatment following episiotomy has relied on non-steroid anti-inflammatory drugs as analgesics, whose use during breastfeeding remains controversial due of their transfer to the child.
METHODS


This was a pilot randomized parallel single-center study aiming to evaluate the effects of auricular acupuncture on pain relief after episiotomy. The primary outcome was reduction of pain intensity using visual analogue scale (VAS) scores during the first three postpartum days. The patients were allocated to either of the groups by using a heads-tails binary result coin toss method and the allocation was not masked. The study was completed after including 60 healthy women that underwent mediolateral episiotomy performed during vaginal delivery, with 29 receiving acupuncture therapy and 31 not receiving acupuncture therapy for pain relief. Oral analgesic therapy was made available per request for all patients.
RESULTS


This study showed that subjective experience of pain was significantly reduced in the acupuncture group on the second and third postpartum days (P = 0.004, P = 0.005, P = 0.22). There were no adverse effects of acupuncture noted.
CONCLUSIONS


Our findings confirm that auricular acupuncture therapy may be a valuable adjunct to analgesic therapy in patients undergoing episiotomy during vaginal delivery. The results prompt a question whether our current 'best practice' may yet be improved.",2019,"There were no adverse effects of acupuncture noted.
","['60 healthy women that underwent', 'after episiotomy', 'patients undergoing episiotomy during vaginal delivery']","['acupuncture', 'auricular acupuncture therapy', 'auricular acupuncture', 'mediolateral episiotomy performed during vaginal delivery, with 29 receiving acupuncture therapy and 31 not receiving acupuncture therapy', 'Oral analgesic therapy', 'Auricular acupuncture']","['effective pain relief', 'pain relief', 'subjective experience of pain', 'reduction of pain intensity using visual analogue scale (VAS) scores']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0752217', 'cui_str': 'Auricular Acupuncture'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral (qualifier value)'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture Treatment'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0412784', 'cui_str': 'Analgesic technique (procedure)'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",60.0,0.130774,"There were no adverse effects of acupuncture noted.
","[{'ForeName': 'Katarina Kličan', 'Initials': 'KK', 'LastName': 'Jaić', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Management, University Hospital Center Sestre Milosrdnice, Zagreb, Croatia.'}, {'ForeName': 'Tihana Magdić', 'Initials': 'TM', 'LastName': 'Turković', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Management, University Hospital Center Sestre Milosrdnice, Zagreb, Croatia.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Pešić', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Management, University Hospital Center Sestre Milosrdnice, Zagreb, Croatia.'}, {'ForeName': 'Ivka', 'Initials': 'I', 'LastName': 'Djaković', 'Affiliation': 'Clinical Department of Gynecology and Obstetrics, University Hospital Center Sestre Milosrdnice, Zagreb, Croatia.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Košec', 'Affiliation': 'Clinical Department of Gynecology and Obstetrics, University Hospital Center Sestre Milosrdnice, Zagreb, Croatia.'}, {'ForeName': 'Andro', 'Initials': 'A', 'LastName': 'Košec', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Center Sestre Milosrdnice, Vinogradska cesta 29, Zagreb, Croatia. andro.kosec@yahoo.com.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-019-05283-w']
741,31802233,A single paravertebral injection via a needle vs. a catheter for the spreading to multiple intercostal levels: a randomized controlled trial.,"PURPOSE


Thoracic paravertebral block (TPVB) provides a unilateral nerve block at multiple intercostal levels allowing injection of a local anesthetic into paravertebral space (PVS) via a needle or catheter. However, the most effective injection method remains unclear. This study compared the real-time spread of ropivacaine between two paravertebral injection methods using thoracoscopy.
METHODS


Thirty-four patients scheduled for thoracoscopic surgery were randomly allocated into the Needle or Catheter groups, and performed transverse in-plane ultrasound-guided TPVB. The Needle group received 20 ml of 0.5% ropivacaine via a needle placed into the lateral edge of PVS; the Catheter group received the same dose of ropivacaine via a catheter inserted 5 cm into PVS. The primary outcome was the spreading pattern of ropivacaine in each group. The secondary outcome was intraoperative vasopressor requirement after paravertebral injection.
RESULTS


In the Needle group, all cases showed ropivacaine spread to multiple intercostal levels, mainly across the ribs. Contrastingly, the Catheter group showed variable spreading patterns; multiple intercostal levels (n = 10) [across the ribs (n = 4), anterolateral aspect of the vertebral bodies (n = 6)] or unobservable spreading (no change; n = 7) (P = 0.007). Vasopressors were required in two and ten cases in the Needle and Catheter groups, respectively (P = 0.010).
CONCLUSION


Paravertebral injection via a needle typically resulted in spreading to multiple intercostal levels, especially across the ribs on the peripheral side of injection site, whereas injection via a catheter resulted in variable spreading patterns. Therefore, injections via needles are more stable.",2020,"Vasopressors were required in two and ten cases in the Needle and Catheter groups, respectively (P = 0.010).
",['Thirty-four patients scheduled for thoracoscopic surgery'],"['ropivacaine', 'Thoracic paravertebral block (TPVB', '20\xa0ml of 0.5% ropivacaine', 'ropivacaine via a catheter inserted 5\xa0cm into PVS', 'Needle or Catheter groups, and performed transverse in-plane ultrasound-guided TPVB']","['unobservable spreading', 'spreading pattern of ropivacaine', 'anterolateral aspect of the vertebral bodies', 'intraoperative vasopressor requirement after paravertebral injection', 'variable spreading patterns; multiple intercostal levels']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0751551', 'cui_str': 'Surgical Procedures, Thoracoscopic'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0332261', 'cui_str': 'Spread (attribute)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral (qualifier value)'}, {'cui': 'C0223084', 'cui_str': 'Structure of body of vertebra'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",34.0,0.036128,"Vasopressors were required in two and ten cases in the Needle and Catheter groups, respectively (P = 0.010).
","[{'ForeName': 'Tasuku', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Department of Anesthesiology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8560, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Shibata', 'Affiliation': 'Department of Surgical Center, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Ban', 'Affiliation': 'Department of Anesthesiology, Tosei General Hospital, Seto, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Shitaokoshi', 'Affiliation': 'Department of Anesthesiology, Tosei General Hospital, Seto, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Biostatistics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Matsui', 'Affiliation': 'Department of Biostatistics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Kimitoshi', 'Initials': 'K', 'LastName': 'Nishiwaki', 'Affiliation': 'Department of Anesthesiology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8560, Japan. nishi@med.nagoya-u.ac.jp.'}]",Journal of anesthesia,['10.1007/s00540-019-02713-6']
742,32197956,"Randomized Trial on the Effects of High-Dose Zopiclone on OSA Severity, Upper Airway Physiology, and Alertness.","BACKGROUND


Studies indicate that standard doses of hypnotics reduce or do not change the apnea-hypopnea index (AHI) or pharyngeal muscle activity. A 1-month trial of nightly zopiclone (7.5 mg) modestly reduced the AHI vs baseline without changing other sleep parameters or next-day sleepiness.
RESEARCH QUESTION


This study aimed to determine the effects of high-dose zopiclone (15 mg) on AHI, arousal threshold, genioglossus muscle responsiveness, and next-day alertness in selected people with OSA (low to moderate arousal thresholds without major overnight hypoxemia). We hypothesized that high-dose zopiclone would yield greater increases in arousal threshold and therefore larger reductions in AHI but may come at the expense of increased hypoxemia and next-day impairment.
STUDY DESIGN AND METHODS


Twenty-eight participants (AHI = 29 ± 20 events/h) suspected to have low to moderate arousal thresholds were studied during two in-laboratory polysomnographies, separated by 1 week, with an epiglottic pressure catheter and genioglossus intramuscular electrodes. Participants received 15 mg of zopiclone or placebo at each visit according to a double-blind, randomized, crossover design. Each morning, subjective sleepiness and alertness via a driving simulator task were assessed.
RESULTS


The AHI did not change from placebo to zopiclone (-1.5 events/h; 95% CI, -6.6 to 3.5 events/h; P = .54). Arousal threshold, genioglossus muscle responsiveness, and most other sleep parameters and measures of next-day sleepiness and alertness also did not change with zopiclone.
INTERPRETATION


A single night of treatment with high-dose zopiclone does not systematically reduce the AHI or increase the arousal threshold in selected people with OSA. The mechanisms for these unexpected findings require further investigation.
TRIAL REGISTRY


Australian New Zealand Clinical Trials Registry; No.: ACTRN12617000988358; URL: https://www.anzctr.org.au.",2020,"Arousal threshold, genioglossus muscle responsiveness and most other sleep parameters and measures of next-day sleepiness and alertness also did not change with zopiclone.
","['selected people with obstructive sleep apnea (OSA) (low-moderate arousal thresholds without major overnight hypoxemia', 'and methods: 28 participants (AHI=29±20events/h) suspected to have low-moderate arousal thresholds']","['high-dose zopiclone', 'zopiclone or placebo', 'epiglottic pressure catheter and genioglossus intramuscular electrodes', 'nightly zopiclone']","['AHI, arousal threshold, genioglossus muscle responsiveness and next-day alertness', 'Arousal threshold, genioglossus muscle responsiveness', 'subjective sleepiness and alertness via a driving simulator task', 'OSA severity, upper airway physiology and alertness', 'apnea-hypopnea index (AHI) or pharyngeal muscle activity', 'sleep parameters and measures of next-day sleepiness and alertness']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0078847', 'cui_str': 'zopiclone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0013812', 'cui_str': 'Electrode, device (physical object)'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0224194', 'cui_str': 'Structure of genioglossus muscle'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0031346', 'cui_str': 'Muscles of Pharynx'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.288769,"Arousal threshold, genioglossus muscle responsiveness and most other sleep parameters and measures of next-day sleepiness and alertness also did not change with zopiclone.
","[{'ForeName': 'Sophie G', 'Initials': 'SG', 'LastName': 'Carter', 'Affiliation': 'Neuroscience Research Australia (NeuRA) and the University of New South Wales, Sydney, NSW. Electronic address: s.carter@neura.edu.au.'}, {'ForeName': 'Jayne C', 'Initials': 'JC', 'LastName': 'Carberry', 'Affiliation': 'Neuroscience Research Australia (NeuRA) and the University of New South Wales, Sydney, NSW; Adelaide Institute for Sleep Health, Flinders University, Adelaide, SA.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Grunstein', 'Affiliation': 'Woolcock Institute of Medical Research and the University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Danny J', 'Initials': 'DJ', 'LastName': 'Eckert', 'Affiliation': 'Neuroscience Research Australia (NeuRA) and the University of New South Wales, Sydney, NSW; Adelaide Institute for Sleep Health, Flinders University, Adelaide, SA.'}]",Chest,['10.1016/j.chest.2020.02.057']
743,32195715,Does a Hand Strength-Focused Exercise Program Improve Grip Strength in Older Patients With Wrist Fractures Managed Nonoperatively?: A Randomized Controlled Trial.,"OBJECTIVE


Distal radius fractures in the older population significantly impair grip strength. The aim of the study was to investigate whether a hand strength focused exercise program during the period of immobilization for nonoperatively managed distal radius fractures in this population improved grip strength and quality of life.
DESIGN


This is a single-center randomized controlled trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Fifty-two patients older than 60 yrs who experienced distal radius fractures managed nonoperatively with cast immobilization. The intervention group (n = 26) received a home hand strength-focused exercise program from 2 and 6 wks after injury while immobilized in a full short arm cast. The control group (n = 26) performed finger range of motion exercises as per protocol. Primary outcome was grip strength ratio of injured arm compared with uninjured arm. Secondary outcome included functional scores of the 11-item shortened version of the Disabilities of the Arm, Shoulder and Hand. Outcomes were measured at 2, 6, and 12 wks after injury.
RESULTS


The intervention group significantly improved grip strength ratio at both 6 and 12 wks (6 wks: 40% vs 25%, P = 0.0044, and 12 wks: 81% vs 51%, P = 0.0035). The intervention group improved the 11-item Disabilities of the Arm, Shoulder and Hand score at 12 wks; however, this was not statistically significant (25 vs 40, P = 0.066).
CONCLUSIONS


A hand strength-focused exercise program for elderly patients with distal radius fractures while immobilized significantly improved grip strength.",2020,The intervention group significantly improved grip strength ratio at both 6 and 12 wks,"['Older Patients', 'Fifty-two patients older than 60 yrs who experienced distal radius fractures managed nonoperatively with cast immobilization', 'elderly patients with distal radius fractures']","['home hand strength-focused exercise program from 2 and 6 wks after injury while immobilized in a full short arm cast', 'A hand strength-focused exercise program', 'hand strength focused exercise program', 'Hand Strength-Focused Exercise Program', 'finger range of motion exercises as per protocol']","['grip strength and quality of life', 'functional scores of the 11-item shortened version of the Disabilities of the Arm, Shoulder and Hand', '11-item Disabilities of the Arm, Shoulder and Hand score', 'grip strength ratio of injured arm compared with uninjured arm', 'grip strength ratio', 'grip strength']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius (body structure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0242959', 'cui_str': 'Hand Strength'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0426857', 'cui_str': 'Short arm (finding)'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0575830', 'cui_str': 'Joint movement: finger'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",52.0,0.0849428,The intervention group significantly improved grip strength ratio at both 6 and 12 wks,"[{'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Nguyen', 'Affiliation': 'From the Liverpool Hospital, Liverpool, New South Wales, Australia (AN); Concord Hospital, Sydney, New South Wales, Australia (AN, MV, GB, DM, MW, MK, JS); and Royal North Shore Hospital, Sydney, New South Wales, Australia (GB, MK).'}, {'ForeName': 'Mehr', 'Initials': 'M', 'LastName': 'Vather', 'Affiliation': ''}, {'ForeName': 'Gobind', 'Initials': 'G', 'LastName': 'Bal', 'Affiliation': ''}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Meaney', 'Affiliation': ''}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'White', 'Affiliation': ''}, {'ForeName': 'Myles', 'Initials': 'M', 'LastName': 'Kwa', 'Affiliation': ''}, {'ForeName': 'Jai', 'Initials': 'J', 'LastName': 'Sungaran', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001317']
744,32019428,Sleep for Stroke Management and Recovery Trial (Sleep SMART): Rationale and methods.,"RATIONALE


Obstructive sleep apnea is common among patients with acute ischemic stroke and is associated with reduced functional recovery and an increased risk for recurrent vascular events.
AIMS AND/OR HYPOTHESIS


The Sleep for Stroke Management and Recovery Trial (Sleep SMART) aims to determine whether automatically adjusting continuous positive airway pressure (aCPAP) treatment for obstructive sleep apnea improves clinical outcomes after acute ischemic stroke or high-risk transient ischemic attack.
SAMPLE SIZE ESTIMATE


A total of 3062 randomized subjects for the prevention of recurrent serious vascular events, and among these, 1362 stroke survivors for the recovery outcome.
METHODS AND DESIGN


Sleep SMART is a phase III, multicenter, prospective randomized, open, blinded outcome event assessed controlled trial. Adults with recent acute ischemic stroke/transient ischemic attack and no contraindication to aCPAP are screened for obstructive sleep apnea with a portable sleep apnea test. Subjects with confirmed obstructive sleep apnea but without predominant central sleep apnea proceed to a run-in night of aCPAP. Subjects with use (≥4 h) of aCPAP and without development of significant central apneas are randomized to aCPAP plus usual care or care-as-usual for six months. Telemedicine is used to monitor and facilitate aCPAP adherence remotely.
STUDY OUTCOMES


Two separate primary outcomes: (1) the composite of recurrent acute ischemic stroke, acute coronary syndrome, and all-cause mortality (prevention) and (2) the modified Rankin scale scores (recovery) at six- and three-month post-randomization, respectively.
DISCUSSION


Sleep SMART represents the first large trial to test whether aCPAP for obstructive sleep apnea after stroke/transient ischemic attack reduces recurrent vascular events or death, and improves functional recovery.",2020,Subjects with use (≥4 h) of aCPAP and without development of significant central apneas are randomized to aCPAP plus usual care or care-as-usual for six months.,"['Subjects with use (≥4\u2009h) of aCPAP and without development of significant central apneas', 'Subjects with confirmed obstructive sleep apnea but without predominant central sleep apnea', 'Adults with recent acute ischemic stroke/transient ischemic attack and no contraindication to aCPAP are screened for obstructive sleep apnea with a portable sleep apnea test', '3062 randomized subjects for the prevention of recurrent serious vascular events, and among these, 1362 stroke survivors for the recovery outcome', 'patients with acute ischemic stroke', 'Sleep SMART']","['aCPAP', 'aCPAP plus usual care or care-as-usual for six months', 'Telemedicine', 'automatically adjusting continuous positive airway pressure (aCPAP) treatment']","['obstructive sleep apnea', 'composite of recurrent acute ischemic stroke, acute coronary syndrome, and all-cause mortality (prevention) and (2) the modified Rankin scale scores (recovery']","[{'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0520680', 'cui_str': 'Ondine Syndrome'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C3887547', 'cui_str': 'Central sleep apnea syndrome (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439589', 'cui_str': 'Recurrent acute (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",3062.0,0.0612725,Subjects with use (≥4 h) of aCPAP and without development of significant central apneas are randomized to aCPAP plus usual care or care-as-usual for six months.,"[{'ForeName': 'Devin L', 'Initials': 'DL', 'LastName': 'Brown', 'Affiliation': 'Division of Vascular Neurology and Division of Sleep Medicine, Department of Neurology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Durkalski', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Durmer', 'Affiliation': 'Nox Health, Johns Creek, GA, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Broderick', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, UC Gardner Neuroscience Institute, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Darin B', 'Initials': 'DB', 'LastName': 'Zahuranec', 'Affiliation': 'Division of Vascular Neurology, Department of Neurology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Levine', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'Faculty of Medicine, The George Institute for Global Health, UNSW, Sydney, Australia.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Bravata', 'Affiliation': 'Department of Internal Medicine and Neurology, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'H Klar', 'Initials': 'HK', 'LastName': 'Yaggi', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Lewis B', 'Initials': 'LB', 'LastName': 'Morgenstern', 'Affiliation': 'Division of Vascular Neurology, Department of Neurology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Claudia S', 'Initials': 'CS', 'LastName': 'Moy', 'Affiliation': 'National Institutes of Neurological Disorders and Stroke, Bethesda, MD, USA.'}, {'ForeName': 'Ronald D', 'Initials': 'RD', 'LastName': 'Chervin', 'Affiliation': 'Department of Neurology and Sleep Disorders Center, University of Michigan, Ann Arbor, MI, USA.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493020903979']
745,24628577,"Effect of supplementation with a lipid-based nutrient supplement on the micronutrient status of children aged 6-18 months living in the rural region of Intibucá, Honduras.","BACKGROUND


Lipid-based nutrient supplements (LNS) have been effective in the treatment of acute malnutrition among children. We evaluated the use of LNS supplementation for improving the micronutrient status of young children.
METHODS


A 12-month randomised controlled trial was conducted among children aged 6-18 months living in Intibucá, Honduras. Communities (n = 18) were randomised into clusters matched by poverty indicators (9 intervention, n = 160 and 9 controls, n = 140). Intervention participants received LNS. All children received food vouchers and nutrition education. Primary outcomes included measures of micronutrient status: at baseline, 6 and 12 months' blood were collected for assessment of folate, iron, zinc, riboflavin, and vitamin B12 status; haemoglobin was measured every 3 months; and dietary and anthropometry collected monthly. Longitudinal analyses were based on intent to treat and LNS adherence. Generalised estimating equations were used in the estimation of generalised linear regression models specified for the data.
RESULTS


At 6-month follow-up, children in the intervention group had a lower proportion classified as deficient for B12 (43.6%) compared with the control (67.7%; P = 0.03). The intervention group had a higher mean concentration for folate at 6 months (P = 0.06), and improvements continued through 12 months for folate (P = 0.002) and vitamin A deficiency (P = 0.03). This pattern of results, with improved significance, remained in subanalysis based on LNS adherence.
CONCLUSION


These data demonstrate that LNS improved select micronutrient status in young non-malnourished Honduran children.",2014,"The intervention group had a higher mean concentration for folate at 6 months (P = 0.06), and improvements continued through 12 months for folate (P = 0.002) and vitamin A deficiency (P = 0.03).","['children aged 6-18 months living in Intibucá, Honduras', 'young children', 'young non-malnourished Honduran children', 'children aged 6-18 months living in the rural region of Intibucá, Honduras', 'acute malnutrition among children', 'Communities (n\u2009=\u200918']","['food vouchers and nutrition education', 'supplementation with a lipid-based nutrient supplement', 'LNS', 'LNS supplementation', 'Lipid-based nutrient supplements (LNS']","['mean concentration for folate', 'select micronutrient status', ""measures of micronutrient status: at baseline, 6 and 12 months' blood were collected for assessment of folate, iron, zinc, riboflavin, and vitamin B12 status; haemoglobin""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0373720', 'cui_str': 'Vitamin B2'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0752376,"The intervention group had a higher mean concentration for folate at 6 months (P = 0.06), and improvements continued through 12 months for folate (P = 0.002) and vitamin A deficiency (P = 0.03).","[{'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Siega-Riz', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC; Department of Nutrition, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Yaniré', 'Initials': 'Y', 'LastName': 'Estrada Del Campo', 'Affiliation': ''}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kinlaw', 'Affiliation': ''}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Reinhart', 'Affiliation': ''}, {'ForeName': 'Lindsay H', 'Initials': 'LH', 'LastName': 'Allen', 'Affiliation': ''}, {'ForeName': 'Setareh', 'Initials': 'S', 'LastName': 'Shahab-Ferdows', 'Affiliation': ''}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Heck', 'Affiliation': ''}, {'ForeName': 'Chirayath M', 'Initials': 'CM', 'LastName': 'Suchindran', 'Affiliation': ''}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Bentley', 'Affiliation': ''}]",Paediatric and perinatal epidemiology,['10.1111/ppe.12117']
746,32141343,Comparative study of dulaglutide single-use pen Ateos versus insulin degludec FlexTouch on learning and mock administration time in Japanese patients with type 2 diabetes mellitus - a  post-hoc  analysis.,"Aims:  Clinical data have shown that patients with diabetes require shorter training time to use Ateos versus FlexTouch. Using data acquired from a previous study, self-administration procedures that necessitated more time and repetition during mock injection were evaluated. Methods:  In this open-label task- and interview-based crossover study, 48 self-injection naïve participants with type 2 diabetes mellitus (T2DM) were randomized to 1 of 2 sequences to perform a mock injection of Ateos and FlexTouch into a rubber pad after receiving training. Time needed to conduct mock injection steps (preparation, pre-injection set-up, injection, clean-up), and the number and time needed for repeated steps due to procedural errors, were measured as  post-hoc  analyses. Results:  Mean time for preparation, injection, and clean-up was shorter for Ateos (13, 15, 9 s) versus FlexTouch (96, 53, 36 s). Overall time for administration including repeated steps was 75 s for Ateos and 288 s for FlexTouch. Nine participants repeated procedures due to errors when using Ateos (preparation: 6; pre-injection set-up: 2; injection: 1), and 7 participants when using FlexTouch (preparation: 2; pre-injection set-up: 2; injection: 5). There was 1 repeat per person for Ateos injections versus multiple repeats for FlexTouch injections. Conclusions:   Post-hoc  analysis demonstrates the time needed for overall administration was shorter for Ateos than FlexTouch, and time for each procedure was shorter or similar for Ateos versus FlexTouch. Ateos was easy for participants with T2DM to learn with fewer repeated steps due to procedural errors, and easy for healthcare professionals to introduce to their patients.",2020,"Mean time for preparation, injection, and clean-up was shorter for Ateos (13, 15, 9 seconds) versus FlexTouch (96, 53, 36 seconds).","['48 self-injection naïve participants with type 2 diabetes mellitus (T2DM', 'patients with diabetes', 'Japanese patients with type 2 diabetes']","['dulaglutide single-use pen Ateos versus insulin degludec FlexTouch', 'FlexTouch', 'mock injection of Ateos and FlexTouch into a rubber pad after receiving training']","['Overall time', 'Mean time for preparation, injection, and clean-up']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}]","[{'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C4319659', 'cui_str': 'Pen (unit of presentation)'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0562577', 'cui_str': 'Mocking (finding)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0035918', 'cui_str': 'Natural Rubber'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}]",,0.027082,"Mean time for preparation, injection, and clean-up was shorter for Ateos (13, 15, 9 seconds) versus FlexTouch (96, 53, 36 seconds).","[{'ForeName': 'Toshinari', 'Initials': 'T', 'LastName': 'Asakura', 'Affiliation': 'Faculty of Pharmaceutical Sciences, Niigata University of Pharmacy and Applied Life Sciences, Niigata, Japan.'}, {'ForeName': 'Toshinobu', 'Initials': 'T', 'LastName': 'Yamazaki', 'Affiliation': 'Faculty of Pharmaceutical Sciences, Niigata University of Pharmacy and Applied Life Sciences, Niigata, Japan.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Cai', 'Affiliation': 'Statistical Science, Medicines Development Unit-Japan, Eli Lilly Japan K.K, Kobe, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Aranishi', 'Affiliation': 'Health Outcomes, Health Technology Assessment, Real World Evidence, Medicines Development Unit-Japan, Eli Lilly Japan K.K., Kobe, Japan.'}]",Current medical research and opinion,['10.1080/03007995.2020.1739636']
747,32040077,Perspective-taking influences attentional deployment towards facial expressions of pain: an eye-tracking study.,"Empathetic perspective-taking (PT) may be critical in modulating attention and associated responses to another's pain. However, the differential effects of imagining oneself to be in the pain sufferer's situation (""Self-perspective"") or imagining the negative impacts on the pain sufferer's experience (""Other-perspective"") on attention have not been studied. The effects of observer PT (Self vs Other) and level of facial pain expressiveness (FPE) upon attention to another person's pain was investigated. Fifty-two adults were assigned to 1 of 3 PT conditions; they were instructed to view pairs of pain expressions and neutral faces and either (1) consider their own feelings (Self-perspective), (2) consider the feelings of the person in the picture (Other-perspective), or (3) received no further instructions (Control). Eye movements provided indices of early (probability and duration of first fixation) and later (total gaze duration) attentional deployment. Pain faces were more likely to be fixated upon first. A significant first fixation duration bias towards pain was observed, which increased with increasing levels of FPE, and was higher in the Self-PT than the Control condition. The proportion of total gaze duration on pain faces was higher in both experimental conditions than the Control condition. This effect was moderated by FPE in the Self-PT condition; there was a significant increase from low to high FPE. When observers attend to another's facial display of pain, top-down influences (such as PT) and bottom-up influences (such as sufferer's FPE) interact to control deployment and maintenance of attention.",2020,"A significant first fixation duration bias towards pain was observed, which increased with increasing levels of FPE, and was higher in the Self-PT than the Control condition.",['Fifty-two adults'],"['pain expressions and neutral faces and either 1) consider their own feelings (Self-perspective), 2) consider the feelings of the person in the picture (Other-perspective), or 3) received no further instructions (Control', 'Empathetic perspective-taking (PT', 'Perspective-taking influences attentional deployment']","['facial expressions of pain', 'proportion of total gaze duration on pain faces', 'Eye movements provided indices of early (probability and duration of first fixation) and later (total gaze duration) attentional deployment', 'Pain faces', 'fixation duration bias towards pain', 'levels of FPE']","[{'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205394', 'cui_str': 'Other (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0015457', 'cui_str': 'Facial Expression'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0553544', 'cui_str': 'Gaze (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",52.0,0.0244327,"A significant first fixation duration bias towards pain was observed, which increased with increasing levels of FPE, and was higher in the Self-PT than the Control condition.","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Pilch', 'Affiliation': 'Centre for Health Policy and Management, School of Medicine, Trinity College Dublin, Ireland.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'OʼHora', 'Affiliation': 'School of Psychology, College of Arts, Social Sciences, & Celtic Studies National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Jennings', 'Affiliation': 'Center for Pain Research, School of Psychology, College of Arts, Social Sciences, & Celtic Studies National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Caes', 'Affiliation': 'Division of Psychology, Faculty of Natural Sciences, University of Stirling, United Kingdom.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'McGuire', 'Affiliation': 'School of Psychology, College of Arts, Social Sciences, & Celtic Studies National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Kainz', 'Affiliation': 'Department of Psychology, Faculty of Natural Sciences, University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Tine', 'Initials': 'T', 'LastName': 'Vervoort', 'Affiliation': 'Department of Experimental and Clinical Health Psychology, Faculty of Psychology and Educational Sciences, Ghent University, Ghent, Belgium.'}]",Pain,['10.1097/j.pain.0000000000001827']
748,31952493,The effect of therapeutic drug monitoring of beta-lactam and fluoroquinolones on clinical outcome in critically ill patients: the DOLPHIN trial protocol of a multi-centre randomised controlled trial.,"BACKGROUND


Critically ill patients undergo extensive physiological alterations that will have impact on antibiotic pharmacokinetics. Up to 60% of intensive care unit (ICU) patients meet the pharmacodynamic targets of beta-lactam antibiotics, with only 30% in fluoroquinolones. Not reaching these targets might increase the chance of therapeutic failure, resulting in increased mortality and morbidity, and antibiotic resistance. The DOLPHIN trial was designed to demonstrate the added value of therapeutic drug monitoring (TDM) of beta-lactam and fluoroquinolones in critically ill patients in the ICU.
METHODS


A multi-centre, randomised controlled trial (RCT) was designed to assess the efficacy and cost-effectiveness of model-based TDM of beta-lactam and fluoroquinolones. Four hundred fifty patients will be included within 24 months after start of inclusion. Eligible patients will be randomly allocated to either study group: the intervention group (active TDM) or the control group (non-TDM). In the intervention group dose adjustment of the study antibiotics (cefotaxime, ceftazidime, ceftriaxone, cefuroxime, amoxicillin, amoxicillin with clavulanic acid, flucloxacillin, piperacillin with tazobactam, meropenem, and ciprofloxacin) on day 1, 3, and 5 is performed based upon TDM with a Bayesian model. The primary outcome will be ICU length of stay. Other outcomes amongst all survival, disease severity, safety, quality of life after ICU discharge, and cost effectiveness will be included.
DISCUSSION


No trial has investigated the effect of early TDM of beta-lactam and fluoroquinolones on clinical outcome in critically ill patients. The findings from the DOLPHIN trial will possibly lead to new insights in clinical management of critically ill patients receiving antibiotics. In short, to TDM or not to TDM?
TRIAL REGISTRATION


EudraCT number: 2017-004677-14. Sponsor protocol name: DOLPHIN. Registered 6 March 2018 . Protocol Version 6, Protocol date: 27 November 2019.",2020,Eligible patients will be randomly allocated to either study group: the intervention group (active TDM) or the control group (non-TDM).,"['Four hundred fifty patients will be included within 24\u2009months after start of inclusion', 'Eligible patients', 'critically ill patients', 'critically ill patients receiving antibiotics', 'critically ill patients in the ICU']","['antibiotics (cefotaxime, ceftazidime, ceftriaxone, cefuroxime, amoxicillin, amoxicillin with clavulanic acid, flucloxacillin, piperacillin with tazobactam, meropenem, and ciprofloxacin', 'intervention group (active TDM) or the control group (non-TDM', 'beta-lactam and fluoroquinolones', 'fluoroquinolones', 'model-based TDM of beta-lactam and fluoroquinolones']","['survival, disease severity, safety, quality of life after ICU discharge, and cost effectiveness', 'ICU length of stay', 'mortality and morbidity, and antibiotic resistance', 'efficacy and cost-effectiveness']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0007554', 'cui_str': 'Cefotaxime'}, {'cui': 'C0007559', 'cui_str': 'Ceftazidime'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0007562', 'cui_str': 'Cefuroxime'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0055860', 'cui_str': 'Clavulanic Acid'}, {'cui': 'C0016267', 'cui_str': 'flucloxacillin'}, {'cui': 'C0031955', 'cui_str': 'Piperacillin'}, {'cui': 'C0075870', 'cui_str': 'tazobactam'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282215', 'cui_str': 'beta-Lactams'}, {'cui': 'C0949665', 'cui_str': 'Fluoroquinolones'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034380'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance, Microbial'}]",450.0,0.260615,Eligible patients will be randomly allocated to either study group: the intervention group (active TDM) or the control group (non-TDM).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Abdulla', 'Affiliation': 'Department of Hospital Pharmacy, Erasmus University Medical Center, P.O. Box 2040, 3000, CA, Rotterdam, the Netherlands. a.abdulla@erasmusmc.nl.'}, {'ForeName': 'T M J', 'Initials': 'TMJ', 'LastName': 'Ewoldt', 'Affiliation': 'Department of Intensive Care, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'N G M', 'Initials': 'NGM', 'LastName': 'Hunfeld', 'Affiliation': 'Department of Hospital Pharmacy, Erasmus University Medical Center, P.O. Box 2040, 3000, CA, Rotterdam, the Netherlands.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Muller', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'W J R', 'Initials': 'WJR', 'LastName': 'Rietdijk', 'Affiliation': 'Department of Intensive Care, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Polinder', 'Affiliation': 'Department of Public Health, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'van Gelder', 'Affiliation': 'Department of Hospital Pharmacy, Erasmus University Medical Center, P.O. Box 2040, 3000, CA, Rotterdam, the Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Endeman', 'Affiliation': 'Department of Intensive Care, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'B C P', 'Initials': 'BCP', 'LastName': 'Koch', 'Affiliation': 'Department of Hospital Pharmacy, Erasmus University Medical Center, P.O. Box 2040, 3000, CA, Rotterdam, the Netherlands.'}]",BMC infectious diseases,['10.1186/s12879-020-4781-x']
749,31576450,Comparison of pelvic floor muscle training isolated and associated with weight loss: a randomized controlled trial.,"PURPOSE


To analyze whether pelvic floor muscle training (PFMT) associated with weight loss (WL) is better than isolated PFMT to provide additional beneficial effects to urinary symptoms in women with MUI.
METHODS


A randomized, simple-blind parallel controlled trial was performed and included women with MUI aged between 40 and 65 years and body mass index between 25 and 40 kg/m 2 . The sample was randomized into two groups: 11 PFMT + WL and 11 PFMT. Data collection was performed in baseline and after interventions. The primary outcome was to investigate the loss of urine. Secondary aim includes PFM pressure and quality of life. PFMT was performed with two sets of eight repetitions in the first 4 weeks, and with three sets of eight repetitions in the final 4 weeks. The weight loss program was based on the calculation of total energy value needs. Data analysis was performed by SPSS 20.0 software and one-way ANCOVA.
RESULTS


22 volunteers participated in the study. There was no intergroup significant difference in post-intervention ICIQ-SF F(1, 19) = 7.115, p = 0.87, partial η 2  = 0.001; manometry F(1, 19) = 0.608, p = 0.44, partial η 2  = 0.003; pad test 1 h F(1, 19) = 0.185, p = 0.67, partial η 2  = 0.01; QoL F(1, 19) = 1.018, p = 0.32, partial η 2  = 0.05; and weight F(1, 19) = 0.251, p = 0.62, partial η 2  = 0.01.
CONCLUSIONS


Weight loss did not provide additional beneficial effects to PFMT in women with overweight or obesity grade I with MUI symptoms.",2019,"There was no intergroup significant difference in post-intervention ICIQ-SF F(1, 19) = 7.115, p = 0.87, partial η 2  = 0.001; manometry F(1, 19) = 0.608, p = 0.44, partial η 2  = 0.003; pad test 1 h F(1, 19) = 0.185, p = 0.67, partial η 2  = 0.01; QoL F(1, 19) = 1.018, p = 0.32, partial η 2  = 0.05; and weight F(1, 19) = 0.251, p = 0.62, partial η 2  = 0.01.
","['women with overweight or obesity grade I with MUI symptoms', 'women with MUI', '22 volunteers participated in the study', 'women with MUI aged between 40 and 65\xa0years and body mass index between 25 and 40\xa0kg']","['pelvic floor muscle training', 'PFMT\u2009+\u2009WL and 11 PFMT', 'PFMT', 'pelvic floor muscle training (PFMT']","['PFM pressure and quality of life', 'loss of urine', 'weight loss']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0042037'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",22.0,0.251451,"There was no intergroup significant difference in post-intervention ICIQ-SF F(1, 19) = 7.115, p = 0.87, partial η 2  = 0.001; manometry F(1, 19) = 0.608, p = 0.44, partial η 2  = 0.003; pad test 1 h F(1, 19) = 0.185, p = 0.67, partial η 2  = 0.01; QoL F(1, 19) = 1.018, p = 0.32, partial η 2  = 0.05; and weight F(1, 19) = 0.251, p = 0.62, partial η 2  = 0.01.
","[{'ForeName': 'Maria Clara Eugênia', 'Initials': 'MCE', 'LastName': 'de Oliveira', 'Affiliation': 'Health Science Center, Federal University of Rio Grande do Norte, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Vanessa Cristina', 'Initials': 'VC', 'LastName': 'de Oliveira de Lima', 'Affiliation': 'Health Science Center, Federal University of Rio Grande do Norte, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Pegado', 'Affiliation': 'Graduate Program in Rehabilitation Science, Federal University of Rio Grande do Norte, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Edson Meneses', 'Initials': 'EM', 'LastName': 'Silva-Filho', 'Affiliation': 'Graduate Program in Rehabilitation Science, Federal University of Rio Grande do Norte, Rio Grande do Norte, Brazil. meneses.edson@yahoo.com.br.'}, {'ForeName': 'Ana Paula Trussardi', 'Initials': 'APT', 'LastName': 'Fayh', 'Affiliation': 'Health Science Center, Federal University of Rio Grande do Norte, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Maria Thereza', 'Initials': 'MT', 'LastName': 'Micussi', 'Affiliation': 'Health Science Center, Federal University of Rio Grande do Norte, Rio Grande do Norte, Brazil.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-019-05319-1']
750,31079232,"Complementary low-level laser therapy for breast cancer-related lymphedema: a pilot, double-blind, randomized, placebo-controlled study.","This pilot, double-blind, randomized, placebo-controlled study is aimed at evaluating the effectiveness of low-level laser therapy (LLLT) as a complementary treatment to complete decongestive therapy (CDT) treating lymphedema among breast cancer patients for 12 months post-intervention. Study population was breast cancer patients who were diagnosed and referred to lymphedema clinic for CDT. Participants (n = 22) were randomized and assigned into either an active laser intervention group or an inactive laser placebo-control group. Active LLLT was administered to participants twice a week at the beginning of each CDT session. Outcome measures included lymphedema symptoms, symptom distress, and limb volume by an infrared perometer. Participants in the active and placebo laser groups were comparable in demographic and clinical predictors of lymphedema. In comparison with the placebo group (83.3%), significantly fewer participants in the active laser group (55.6%) reported more than one lymphedema symptom (p = 0.012) at 12 months post-intervention. Significantly, more patients in the active laser group (44.4%) reported less than two impaired limb mobility symptoms in comparison with the placebo group (33.3%) at 12 months post-intervention (p = 0.017). The active laser group had statistically significant improvements in symptom distress of sadness (p = 0.005) from 73 to 11% and self-perception (p = 0.030) from 36 to 0% over time from baseline to 12-months post-intervention. There was no significant reduction in limb volume. Findings of the trial demonstrated significant benefits of complementary LLLT for relieving symptoms and improvement of emotional distress in breast cancer patients with lymphedema.",2020,The active laser group had statistically significant improvements in symptom distress of sadness (p = 0.005) from 73 to 11% and self-perception (p = 0.030) from 36 to 0% over time from baseline to 12-months post-intervention.,"['breast cancer patients with lymphedema', 'breast cancer-related lymphedema', 'Study population was breast cancer patients who were diagnosed and referred to lymphedema clinic for CDT', 'breast cancer patients for 12\xa0months post-intervention', 'Participants (n\u2009=\u200922']","['placebo', 'complementary LLLT', 'active laser intervention group or an inactive laser placebo-control group', 'Active LLLT', 'placebo laser', 'low-level laser therapy (LLLT', 'Complementary low-level laser therapy']","['demographic and clinical predictors of lymphedema', 'lymphedema symptom', 'emotional distress', 'limb volume', 'symptom distress of sadness', 'lymphedema symptoms, symptom distress, and limb volume by an infrared perometer', 'limb mobility symptoms']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3838919', 'cui_str': 'Lymphedema clinic (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4019433', 'cui_str': 'LLLT'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0279027', 'cui_str': 'Low-Power Laser Therapy'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}]",,0.502769,The active laser group had statistically significant improvements in symptom distress of sadness (p = 0.005) from 73 to 11% and self-perception (p = 0.030) from 36 to 0% over time from baseline to 12-months post-intervention.,"[{'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Kilmartin', 'Affiliation': 'Rusk Rehabilitation, Ambulatory Care Center, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Denham', 'Affiliation': 'Rusk Rehabilitation, Ambulatory Care Center, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Mei R', 'Initials': 'MR', 'LastName': 'Fu', 'Affiliation': 'Rory Meyers College of Nursing, New York University, 433 First Avenue, 4th Floor, Room 424, New York, NY, 10010, USA. mf67@nyu.edu.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Yu', 'Affiliation': 'Rory Meyers College of Nursing, New York University, 433 First Avenue, 4th Floor, Room 424, New York, NY, 10010, USA.'}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Kuo', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Axelrod', 'Affiliation': 'Department of Surgery, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Amber A', 'Initials': 'AA', 'LastName': 'Guth', 'Affiliation': 'Department of Surgery, New York University School of Medicine, New York, NY, USA.'}]",Lasers in medical science,['10.1007/s10103-019-02798-1']
751,31062131,Influence of different PEEP levels on electrical impedance tomography findings in patients under general anesthesia ventilated in the lateral decubitus position.,"To determine the effect of various PEEP levels on electrical impedance tomography (EIT) measured differences in regional ventilation, hemodynamics, lung mechanics and parameters of alveolar gas exchange. Thirty three patients scheduled for elective urologic surgery in general anesthesia in lateral decubitus position were randomized into three groups-PEEP 0, 5 and 10 mbar. EIT recording, arterial blood gas analysis and hemodynamic parameters were captured at three timepoints-before induction (T0), 5 min after lateral positioning (T1) and 90 min after positioning (T2). Dynamic compliance (Cdyn) was measured at T1 and T2. Offline EIT data analysis was performed to calculate EIT derived parameters of ventilation distribution. Patients ventilated with PEEP of 10 mbar had a significantly lower A-a (alveolo arterial) gradient over measurements and symmetrical distribution of ventilation measured by EIT. There was no significant difference in Cdyn, center of ventilation indices and inhomogeneity index between groups. There was no difference of mean arterial pressure, cardiac index and heart rate between groups. Patients with 5 mbar of PEEP had higher stroke volume index compared to 0 and 10 mbar at baseline and over measurements. Nondependent/dependent TV ratio as well as global inhomogeneity index were correlated with A-a gradient. Dynamic compliance showed no correlation to A-a gradient. In our study, a PEEP level of 10 mbar improved alveolar gas exchange without compromising hemodynamic stability in patients mechanically ventilated in the lateral decubitus position. EIT measured parameters may be used to determine optimal ventilation parameters in these patients with inhomogeneous lung mechanics. Further studies are needed in patients with various lung pathologies.",2020,"There was no significant difference in Cdyn, center of ventilation indices and inhomogeneity index between groups.","['patients mechanically ventilated in the lateral decubitus position', 'patients under general anesthesia ventilated in the lateral decubitus position', 'patients with various lung pathologies', 'Thirty three patients scheduled for elective urologic surgery in general anesthesia in lateral decubitus position', 'Patients with 5\xa0mbar of', 'patients with inhomogeneous lung mechanics']",['PEEP'],"['Dynamic compliance (Cdyn', 'mean arterial pressure, cardiac index and heart rate', 'lower A-a (alveolo arterial) gradient over measurements and symmetrical distribution of ventilation measured by EIT', 'EIT recording, arterial blood gas analysis and hemodynamic parameters', 'stroke volume index', 'global inhomogeneity index', 'Cdyn, center of ventilation indices and inhomogeneity index', 'regional ventilation, hemodynamics, lung mechanics and parameters of alveolar gas exchange']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position (finding)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}]","[{'cui': 'C0863179', 'cui_str': 'Peeping'}]","[{'cui': 'C0429680', 'cui_str': 'Dynamic compliance (observable entity)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0231933', 'cui_str': 'Distribution of ventilation, function (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0596601', 'cui_str': 'Gas'}]",33.0,0.0457474,"There was no significant difference in Cdyn, center of ventilation indices and inhomogeneity index between groups.","[{'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Šribar', 'Affiliation': 'Clinical Department of Anesthesiology, Resuscitation and Intensive Care Medicine, University Hospital Dubrava, Av. Gojka Šuška 6, 10000, Zagreb, Croatia. andrej.sribar@gmail.com.'}, {'ForeName': 'Vlasta', 'Initials': 'V', 'LastName': 'Merc', 'Affiliation': 'Clinical Department of Anesthesiology, Resuscitation and Intensive Care Medicine, University Hospital Dubrava, Av. Gojka Šuška 6, 10000, Zagreb, Croatia.'}, {'ForeName': 'Zoran', 'Initials': 'Z', 'LastName': 'Peršec', 'Affiliation': 'Department of Urology, University Hospital Dubrava, Zagreb, Croatia.'}, {'ForeName': 'Jasminka', 'Initials': 'J', 'LastName': 'Peršec', 'Affiliation': 'Clinical Department of Anesthesiology, Resuscitation and Intensive Care Medicine, University Hospital Dubrava, Av. Gojka Šuška 6, 10000, Zagreb, Croatia.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Milas', 'Affiliation': 'Clinical Department of Urology, University Hospital Center Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Husedžinović', 'Affiliation': 'Zagreb Dental Polyclinic, Zagreb, Croatia.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-019-00318-8']
752,32202313,Benefits of a transtheoretical model-based program on exercise adherence in older adults with knee osteoarthritis: A cluster randomized controlled trial.,"AIMS


Benefits of a transtheoretical model-based exercise program on exercise adherence (primary outcome) and secondary outcomes (self-efficacy, decisional balance, knee osteoarthritis symptoms, and physical function) were assessed among older adults with knee osteoarthritis.
DESIGN


A two-arm, superiority, assessor-blinded, cluster randomized trial with randomization at the community level.
METHODS


Participants were recruited from 14 communities in Beijing between April - October 2018 (N = 189). The intervention was a 24-week transtheoretical model-based exercise program and the control group underwent a non-theory-based exercise program. Exercise adherence was collected every 4 weeks and secondary outcomes were measured at baseline, 12 weeks, and 24 weeks. An independent t test and repeated-measures ANOVA were the main statistical tests.
RESULTS


Most participants were women (92.5%), married (81.4%), with high-school education (36.0%), with both knees affected (50.3%), and did not make use of a walker (93.8%). There were no significant differences between groups in any of the outcome measures at baseline. Repeated-measures ANOVA indicated that there was a significant difference in the trend of adherence scores between the two groups from 0-24 weeks. The independent t test showed that scores in the intervention group were significantly better than in the control group at 16, 20, and 24 weeks. Improvements in the intervention group were also significantly greater in all secondary outcomes than in the control group.
CONCLUSION


A theory-based exercise program could improve exercise adherence, self-efficacy, decisional balance, knee osteoarthritis symptoms, and physical functioning in older adults with knee osteoarthritis.
TRIAL REGISTRATION


Chinese Clinical Trials Registry number ChiCTR1800015458. Registered 31 March 2018.
IMPACT


The 24-week theory-based exercise program could improve exercise adherence, self-efficacy, decisional balance, symptoms of knee osteoarthritis, and physical functioning in older adults with knee osteoarthritis. The theory-based exercise program could help older adults with knee osteoarthritis to improve their symptoms and knee function.",2020,"The independent t-test showed that scores in the intervention group were significantly better than in the control group at 16 weeks, 20 weeks and 24 weeks.","['Participants were recruited from 14 communities in Beijing between April and October 2018 (N = 189', 'older adults with knee osteoarthritis']","['transtheoretical model-based exercise program and the control group underwent a non-theory-based exercise program', 'transtheoretical model-based program', 'exercise program', 'transtheoretical model-based exercise program', 'theory-based exercise program']","['exercise adherence', 'Exercise adherence', 'exercise adherence, self-efficacy, decisional balance, symptoms of knee osteoarthritis and physical functioning', 'exercise adherence, self-efficacy, decisional balance, knee osteoarthritis symptoms and physical functioning', 'secondary outcomes (self-efficacy, decisional balance, knee osteoarthritis symptoms and physical function', 'adherence scores']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.061063,"The independent t-test showed that scores in the intervention group were significantly better than in the control group at 16 weeks, 20 weeks and 24 weeks.","[{'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, Peking University, China, Beijing.'}, {'ForeName': 'Yunlin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Peking University, China, Beijing.'}, {'ForeName': 'Congying', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Peking University Third Hospital, China, Beijing.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'School of Nursing, Peking University, China, Beijing.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': 'Department of Recovery, Peking University Third Hospital, China, Beijing.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'School of Nursing, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Qiaoqin', 'Initials': 'Q', 'LastName': 'Wan', 'Affiliation': 'School of Nursing, Peking University, China, Beijing.'}, {'ForeName': 'Jieru', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, Peking University, China, Beijing.'}, {'ForeName': 'Shaomei', 'Initials': 'S', 'LastName': 'Shang', 'Affiliation': 'School of Nursing, Peking University, China, Beijing.'}]",Journal of advanced nursing,['10.1111/jan.14363']
753,32193264,Influence of combined vitamin D 3  supplementation and resistance exercise training on musculoskeletal health in older men and women (EXVITD): protocol for a randomised controlled trial.,"INTRODUCTION


Sarcopenia is a progressive loss in muscle mass, strength and function, the adverse consequences of which are severe, affecting quality of life and placing an increasing burden on social and healthcare systems. Vitamin D status is known to be associated with markers of sarcopenia, namely muscle mass, strength and function. Also, resistance exercise training (RET) is currently the only proven intervention to treat sarcopenia. However, very little data exist on the influence of combining the two interventions of vitamin D supplementation and resistance exercise training, although a recent systematic review provides tentative support for the current study's hypothesis that the combined intervention may further improve musculoskeletal function above exercise training alone. The aim of the present study is to determine whether vitamin D 3  supplementation is any more effective in improving musculoskeletal function when combined with RET compared with exercise training alone in older adults.
METHODS AND ANALYSIS


This double-blinded randomised placebo-controlled trial will recruit a target of 127 eligible men and women aged ≥65 years living independently or in sheltered housing within the Birmingham area to two groups: (1) 6 months RET and placebo or (2) 6 months RET and 800 IU/d vitamin D 3 . Measures of muscle power (Nottingham Power Rig), body composition (dual energy X-ray absorptiometry), muscle function (short physical performance battery, timed up and go), falls and fractures as events will be assessed. Assessments will take place at baseline and postintervention, with intermittent monitoring of bone turnover, calcium and vitamin D. The primary outcome will be lower limb extensor power output. Analyses of within-group changes and between-group differences in outcome measures are planned.
ETHICS AND DISSEMINATION


The EXVITD study has ethical approval granted by the Black Country National Health Service Research Ethics Committee (14/WM/1220). Results of this trial will be submitted for publication in peer-reviewed journals and presented at conferences. The study is being conducted according to the principles of the Declaration of Helsinki. Trial registration number NCT02467153; Post-results.",2020,"Measures of muscle power (Nottingham Power Rig), body composition (dual energy X-ray absorptiometry), muscle function (short physical performance battery, timed up and go), falls and fractures as events will be assessed.","['older men and women (EXVITD', 'or (2) 6 months RET and 800\u2009IU', '127 eligible men and women aged ≥65 years living independently or in sheltered housing within the Birmingham area to two groups: (1) 6 months', 'older adults']","['resistance exercise training (RET', 'vitamin D 3  supplementation', 'calcium and vitamin D', 'RET and placebo', 'placebo', 'vitamin D supplementation and resistance exercise training', 'exercise training alone', 'combined vitamin D 3  supplementation and resistance exercise training']","['lower limb extensor power output', 'musculoskeletal health', 'muscle power (Nottingham Power Rig), body composition (dual energy X-ray absorptiometry), muscle function (short physical performance battery, timed up and go), falls and fractures as events', 'musculoskeletal function']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0587731', 'cui_str': 'Sheltered housing (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0026861', 'cui_str': 'Musculoskeletal Physiological Concepts'}]",,0.294362,"Measures of muscle power (Nottingham Power Rig), body composition (dual energy X-ray absorptiometry), muscle function (short physical performance battery, timed up and go), falls and fractures as events will be assessed.","[{'ForeName': 'Anneka Elizabeth', 'Initials': 'AE', 'LastName': 'Welford', 'Affiliation': 'School of Sports, Exericse and Rehabilitation Sciences, University of Birmingham, Birmingham, UK aea423@bham.ac.uk.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Lanham-New', 'Affiliation': 'Department of Nutritional Sciences, University of Surrey, Surrey, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Lord', 'Affiliation': 'MRC-Arthritis UK Centre for Musculoskeletal Ageing Research, University of Birmingham, Birmingham, West Midlands, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Doyle', 'Affiliation': 'The Royal Osteoporosis Society, Bath, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Move it or Lose it, Birmingham, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nightingale', 'Affiliation': 'Wellcome Trust Clinical Research Facility, Queen Elizabeth Hospital Birmingham, Birmingham, West Midlands, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Gittoes', 'Affiliation': 'Centre for Endocrinology, Diabetes and Metabolism, Queen Elizabeth Hospital Birmingham, Birmingham, Birmingham, UK.'}, {'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'Greig', 'Affiliation': 'MRC-Versus Arthritis Centre for Musculoskeletal Ageing Research, MRC-Arthritis Research UK Centre for Musculoskeletal Ageing Research, Birmingham, UK.'}]",BMJ open,['10.1136/bmjopen-2019-033824']
754,32029684,"Fever After Influenza, Diphtheria-Tetanus-Acellular Pertussis, and Pneumococcal Vaccinations.","BACKGROUND


Administering inactivated influenza vaccine (IIV), 13-valent pneumococcal conjugate vaccine (PCV13), and diphtheria-tetanus-acellular pertussis (DTaP) vaccine together has been associated with increased risk for febrile seizure after vaccination. We assessed the effect of administering IIV at a separate visit from PCV13 and DTaP on postvaccination fever.
METHODS


In 2017-2018, children aged 12 to 16 months were randomly assigned to receive study vaccines simultaneously or sequentially. They had 2 study visits 2 weeks apart; nonstudy vaccines were permitted at visit 1. The simultaneous group received PCV13, DTaP, and quadrivalent IIV (IIV4) at visit 1 and no vaccines at visit 2. The sequential group received PCV13 and DTaP at visit 1 and IIV4 at visit 2. Participants were monitored for fever (≥38°C) and antipyretic use during the 8 days after visits.
RESULTS


There were 110 children randomly assigned to the simultaneous group and 111 children to the sequential group; 90% received ≥1 nonstudy vaccine at visit 1. Similar proportions of children experienced fever on days 1 to 2 after visits 1 and 2 combined (simultaneous [8.1%] versus sequential [9.3%]; adjusted relative risk = 0.87 [95% confidence interval 0.36-2.10]). During days 1 to 2 after visit 1, more children in the simultaneous group received antipyretics (37.4% vs 22.4%;  P  = .020).
CONCLUSIONS


In our study, delaying IIV4 administration by 2 weeks in children receiving DTaP and PCV13 did not reduce fever occurrence after vaccination. Reevaluating this strategy to prevent fever using an IIV4 with a different composition in a future influenza season may be considered.",2020,Similar proportions of children experienced fever on days 1 to 2 after visits 1 and 2 combined (simultaneous [8.1%] versus sequential [9.3%]; adjusted relative risk = 0.87,"['In 2017-2018, children aged 12 to 16 months', '110 children randomly assigned to the simultaneous group and 111 children to the sequential group; 90% received']","['PCV13, DTaP, and quadrivalent IIV (IIV4) at visit 1 and no vaccines at visit 2', 'influenza vaccine (IIV), 13-valent pneumococcal conjugate vaccine (PCV13), and diphtheria-tetanus-acellular pertussis (DTaP) vaccine', '≥1 nonstudy vaccine', 'PCV13 and DTaP', 'Diphtheria-Tetanus-Acellular Pertussis, and Pneumococcal Vaccinations']","['fever occurrence', 'Fever', 'antipyretics']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C1579319', 'cui_str': 'Streptococcus pneumoniae conjugate vaccine'}, {'cui': 'C0535644', 'cui_str': 'DTaP Vaccines'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0419707', 'cui_str': 'Pneumococcal vaccination (procedure)'}]","[{'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0003419', 'cui_str': 'Antipyretic Agents'}]",110.0,0.15234,Similar proportions of children experienced fever on days 1 to 2 after visits 1 and 2 combined (simultaneous [8.1%] versus sequential [9.3%]; adjusted relative risk = 0.87,"[{'ForeName': 'Emmanuel B', 'Initials': 'EB', 'LastName': 'Walter', 'Affiliation': 'Department of Pediatrics and walte002@mc.duke.edu.'}, {'ForeName': 'Nicola P', 'Initials': 'NP', 'LastName': 'Klein', 'Affiliation': 'Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California, Oakland, California; and.'}, {'ForeName': 'A Patricia', 'Initials': 'AP', 'LastName': 'Wodi', 'Affiliation': 'Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Wes', 'Initials': 'W', 'LastName': 'Rountree', 'Affiliation': 'Duke Human Vaccine Institute, School of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Todd', 'Affiliation': 'Duke Human Vaccine Institute, School of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wiesner', 'Affiliation': 'Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California, Oakland, California; and.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Duffy', 'Affiliation': 'Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Paige L', 'Initials': 'PL', 'LastName': 'Marquez', 'Affiliation': 'Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Karen R', 'Initials': 'KR', 'LastName': 'Broder', 'Affiliation': 'Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia.'}]",Pediatrics,['10.1542/peds.2019-1909']
755,32193258,Independent medical evaluation of general practitioners' follow-up of sick-listed patients: a cross-sectional study in Norway.,"OBJECTIVES


The study was designed to examine the sufficiency of general practitioners' (GPs) follow-up of patients on sick leave, assessed by independent medical evaluators.
DESIGN


Cross-sectional study SETTING: Primary health care in the Western part of Norway. The study reuses data from a randomised controlled trial-the Norwegian independent medical evaluation trial (NIME trial).
PARTICIPANTS


The intervention group in the NIME trial: Sick-listed workers having undergone an independent medical evaluation by an experienced GP at 6 months of unremitting sick leave (n=937; 57% women). In the current study, the participants were distributed into six exposure groups defined by gender and main sick leave diagnoses (women/musculoskeletal, men/musculoskeletal, women/mental, men/mental, women/all other diagnoses and men/all other diagnoses).
OUTCOME MEASURE


The independent medical evaluators assessment (yes/no) of the sufficiency of the regular GPs follow-up of their sick-listed patients.
RESULTS


Estimates from generalised linear models demonstrate a robust association between men with mental sick leave diagnoses and insufficient follow-up by their regular GP first 6 months of sick leave (adjusted relative risk (RR)=1.8, 95% CI=1.15-1.68). Compared with the reference group, women with musculoskeletal sick leave diagnoses, this was the only significant finding. Men with musculoskeletal diagnoses (adjusted RR=1.4, 95% CI=0.92-2.09); men with other diagnoses (adjusted RR=1.0, 95% CI=0.58-1.73); women with mental diagnoses (adjusted RR=1.2, 95% CI=0.75-1.77) and women with other diagnoses (adjusted RR=1.3, 95% CI=0.58-1.73).
CONCLUSIONS


Assessment by an independent medical evaluator showed that men with mental sick leave diagnoses may be at risk of insufficient follow-up by their GP. Efforts should be made to clarify unmet needs to initiate relevant actions in healthcare and work life. Avoiding marginalisation in work life is of the utmost importance.
TRIAL REGISTRATION NUMBER


NCT02524392; Post-results.",2020,"Men with musculoskeletal diagnoses (adjusted RR=1.4, 95% CI=0.92-2.09); men with other diagnoses (adjusted RR=1.0, 95% CI=0.58-1.73); women with mental diagnoses (adjusted RR=1.2, 95% CI=0.75-1.77) and women with other diagnoses (adjusted RR=1.3, 95% CI=0.58-1.73).
","['Primary health care in the Western part of Norway', 'participants were distributed into six exposure groups defined by gender and main sick leave diagnoses (women/musculoskeletal, men/musculoskeletal, women/mental, men/mental, women/all other diagnoses and men/all other diagnoses', 'Sick-listed workers having undergone an independent medical evaluation by an experienced GP at 6\u2009months of unremitting sick leave (n=937; 57% women']",[],['musculoskeletal diagnoses'],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C4277662', 'cui_str': 'Independent Medical Examinations'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",[],[],,0.248772,"Men with musculoskeletal diagnoses (adjusted RR=1.4, 95% CI=0.92-2.09); men with other diagnoses (adjusted RR=1.0, 95% CI=0.58-1.73); women with mental diagnoses (adjusted RR=1.2, 95% CI=0.75-1.77) and women with other diagnoses (adjusted RR=1.3, 95% CI=0.58-1.73).
","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Øyeflaten', 'Affiliation': 'Norwegian National Advisory Unit on Occupational Rehabilitation, Rauland, Norway irene.oyeflaten@arbeidoghelse.no.'}, {'ForeName': 'Silje', 'Initials': 'S', 'LastName': 'Maeland', 'Affiliation': 'NORCE Norwegian Research Centre AS, Bergen, Norway.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Haukenes', 'Affiliation': 'NORCE Norwegian Research Centre AS, Bergen, Norway.'}]",BMJ open,['10.1136/bmjopen-2019-032776']
756,32187168,"Transactional Sex and Incident Chlamydia and Gonorrhea Among Black Men Who Have Sex With Men in Atlanta, Georgia.","BACKGROUND


Black men who have sex with men (BMSM) are disproportionately affected by sexually transmitted infections (STI), including chlamydia and gonorrhea. Transactional sex is an hypothesized risk factor for STI acquisition in BMSM.
METHODS


We estimated the association of transactional sex with incident chlamydia/gonococcal infection among BMSM using longitudinal data from a randomized trial in Atlanta (2012-2015). BMSM were eligible for inclusion if they tested human immunodeficiency virus (HIV)-antibody-negative and reported both ≥2 male sex partners and any condomless anal sex in the last year. We defined chlamydia/gonorrhea incidence as the first occurrence of either rectal or urogenital chlamydia or gonococcal infections after a negative result at enrollment. We used Poisson regression to estimate the incidence rate (IR) for chlamydia/gonorrhea over 12 months. Incidence rate ratios (IRR) compared estimates by reported experience of transactional sex. Subgroup analyses assessed potential heterogeneity by age and sexual identity.
RESULTS


This analysis included 416 BMSM, of whom 191 (46%) were gay-identified, 146 (42%) reported a history of transactional sex, and 57 (14%) had prevalent chlamydia/gonococcal infection at baseline. Over a median of 1 year of follow-up, an additional 55 men tested laboratory-positive for chlamydia/gonorrhea (IR, 17.3 per 100 person-years). Transactional sex was not associated with chlamydia/gonorrhea incidence overall. However, among gay-identified BMSM, transactional sex was associated with incident chlamydia/gonorrhea (IRR, 2.9; 95% confidence interval, 1.2-6.8).
CONCLUSIONS


Economic and social vulnerabilities may motivate engagement in high-risk sexual behaviors through commodified sex, potentially increasing the burden of STIs among BMSM. In this investigation, the relationship between transactional sex and chlamydia/gonorrhea was not homogenous across BMSM with diverse sexual identities in Atlanta, suggesting that within select sexual networks, transactional sex may drive STI risks. Delivering accessible and targeted STI screening for marginalized BMSM should be prioritized for STI and HIV prevention.",2020,"In this investigation, the relationship between transactional sex and chlamydia/gonorrhea was not homogenous across BMSM with diverse sexual identities in Atlanta, suggesting that within select sexual networks transactional sex may drive STI risks.","['Black men who have sex with men (BMSM', '416 BMSM, of whom 191 (46%) were gay identified, 146 (42%) reported a history of transactional sex, and 57 (14%) had prevalent chlamydia/gonococcal infection at baseline', 'black men who have sex with men in Atlanta, Georgia']",[],"['laboratory-positive for chlamydia/gonorrhea', 'incidence rate (IR) for chlamydia/gonorrhea', 'Transactional sex and incident chlamydia and gonorrhea', 'Incidence rate ratios (IRR']","[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C0017454', 'cui_str': 'Georgian S.S.R.'}]",[],"[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0083017', 'cui_str': 'IRR'}]",,0.0642505,"In this investigation, the relationship between transactional sex and chlamydia/gonorrhea was not homogenous across BMSM with diverse sexual identities in Atlanta, suggesting that within select sexual networks transactional sex may drive STI risks.","[{'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Rucinski', 'Affiliation': 'From the Center for Public Health and Human Rights, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Eaton', 'Affiliation': 'Department of Human Development and Family Sciences, University of Connecticut, Storrs, CT.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Learner', 'Affiliation': 'Oak Ridge Institute for Science and Education, Oak Ridge, TN.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Watson', 'Affiliation': 'Department of Human Development and Family Sciences, University of Connecticut, Storrs, CT.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Maksut', 'Affiliation': 'From the Center for Public Health and Human Rights, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Earnshaw', 'Affiliation': 'Department of Human Development & Family Sciences, University of Delaware, Newark, DE.'}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001168']
757,31097414,Effect of a stepped-care intervention delivered by lay health workers on major depressive disorder among primary care patients in Nigeria (STEPCARE): a cluster-randomised controlled trial.,"BACKGROUND


Little is known about how to scale up care for depression in settings where non-physician lay workers constitute the bulk of frontline providers. We aimed to compare a stepped-care intervention package for depression with usual care enhanced by use of the WHO Mental Health Gap Action Programme intervention guide (mhGAP-IG).
METHODS


We did a cluster-randomised trial in primary care clinics in Ibadan, Nigeria. Eligible clinics were those with adequate staffing to provide various 24-h clinical services and with regular physician supervision. Clinics (clusters), anonymised and stratified by local government area, were randomly allocated (1:1) with a computer-generated random number sequence to one of two groups: an intervention group in which patients received a stepped-care intervention (eight sessions of individual problem-solving therapy, with an extra two to four sessions if needed) plus enhanced usual care, and a control group in which patients received enhanced usual care only. Patients from enrolled clinics could participate if they were aged 18 years or older, not pregnant, and had moderate to severe depression (scoring ≥11 on the nine-item patient health questionnaire [PHQ-9]). The primary outcome was the proportion of patients with remission of depression at 12 months (a score of ≤6 on the PHQ-9, with assessors masked to group allocation) in the intention-to-treat population. This trial is registered with the International Standard Randomised Controlled Trials Number registry (ISRCTN46754188) and is completed.
FINDINGS


35 of 97 clinics approached were eligible and agreed to participate, of which 18 were allocated to the intervention group and 17 to the control group. 1178 patients (631 [54%] in the intervention group and 547 [46%] in the control group) were recruited between Dec 2, 2013, and June 29, 2015, among whom 976 (83%) were female and baseline mean PHQ-9 score was 13·7 (SD 2·6). Of the 562 (89%) patients in the intervention group and 473 (86%) in the control group who completed 12-month follow-up, similar proportions in each group had remission of depression (425 [76%] in the intervention group vs 366 [77%] in the control group; adjusted odds ratio 1·0 [95% CI 0·70-1·40]). At 12 months, 17 (3%) deaths, one (<1%) psychotic illness, and one (<1%) case of bipolar disorder in the intervention group, and 16 deaths (3%) and one (<1%) case of bipolar disorder in the control group were recorded. No adverse events were judged to be related to the study procedures.
INTERPRETATION


For patients with moderate to severe depression receiving care from non-physician primary health-care workers in Nigeria, a stepped-care, problem-solving intervention combined with enhanced usual care is similarly effective to enhanced usual care alone. Enhancing usual care with mhGAP-IG might provide simple and affordable approach to scaling up depression care in sub-Saharan Africa.
FUNDING


UK Medical Research Council.",2019,"No adverse events were judged to be related to the study procedures.
","['primary care clinics in Ibadan, Nigeria', 'patients with moderate to severe depression receiving care from non-physician primary health-care workers in Nigeria', '1178 patients (631 [54%] in the intervention group and 547 [46%] in the control group) were recruited between Dec 2, 2013, and June 29, 2015, among whom 976 (83%) were female and baseline mean PHQ-9 score was 13·7 (SD 2·6', 'primary care patients in Nigeria (STEPCARE', 'Eligible clinics were those with adequate staffing to provide various 24-h clinical services and with regular physician supervision', '35 of 97 clinics approached were eligible and agreed to participate, of which 18 were allocated to the intervention group and 17 to the control group', 'Clinics (clusters), anonymised and stratified by local government area', 'Patients from enrolled clinics could participate if they were aged 18 years or older, not pregnant, and had moderate to severe depression (scoring ≥11 on the nine-item patient health questionnaire [PHQ-9']","['mhGAP-IG', 'stepped-care intervention (eight sessions of individual problem-solving therapy, with an extra two to four sessions if needed) plus enhanced usual care, and a control group in which patients received enhanced usual care only', 'stepped-care intervention delivered by lay health workers', 'stepped-care intervention package']","['proportion of patients with remission of depression', 'psychotic illness', 'adverse events', 'bipolar disorder', 'remission of depression']","[{'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0028075', 'cui_str': 'Federal Republic of Nigeria'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0026788', 'cui_str': 'Local Government'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant (finding)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C1704710', 'cui_str': 'Package'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}]",,0.115142,"No adverse events were judged to be related to the study procedures.
","[{'ForeName': 'Oye', 'Initials': 'O', 'LastName': 'Gureje', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria. Electronic address: ogureje@comui.edu.ng.'}, {'ForeName': 'Bibilola D', 'Initials': 'BD', 'LastName': 'Oladeji', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Alan A', 'Initials': 'AA', 'LastName': 'Montgomery', 'Affiliation': ""Nottingham Clinical Trials Unit, University of Nottingham, Queen's Medical Centre, Nottingham, UK.""}, {'ForeName': 'Toyin', 'Initials': 'T', 'LastName': 'Bello', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Lola', 'Initials': 'L', 'LastName': 'Kola', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Akin', 'Initials': 'A', 'LastName': 'Ojagbemi', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Chisholm', 'Affiliation': 'Department of Mental Health and Substance Abuse, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Araya', 'Affiliation': ""Department of Health Services and Population Research, King's College London, London, UK.""}]",The Lancet. Global health,['10.1016/S2214-109X(19)30148-2']
758,32129892,Myasthenia gravis patient and physician opinions about immunosuppressant reduction.,"INTRODUCTION


To reduce myasthenia gravis (MG) patient risk of immunosuppressant (IS) exposure adverse events (AEs), such as infections and malignancies, and to reduce treatment burden, international guidelines recommend decreasing IS dose in stable MG patients.
METHODS


Online surveys were conducted of self-identified MG patients and MG physician experts about the importance of IS dose reduction for MG patients who achieve prolonged periods of disease stability.
RESULTS


Eighty-four percent of MG patients (n = 283) and 100% of physicians (n = 45) were concerned about long-term IS-associated AEs. Although both groups favored attempting IS reduction, they raised concerns including MG relapse, hospitalization, and uncertainty about the future. Presented with an estimated 12% significant relapse rate with IS dose reduction, 76% of patients would be willing to enroll in a randomized IS dose reduction trial.
DISCUSSION


Patients and physicians favor considering IS dose reduction but are also concerned about potential negative sequelae.",2020,"Although both groups favored attempting IS reduction, they raised concerns including: MG relapse, hospitalization, and uncertainty about the future.","['Myasthenia Gravis Patient and Physician Opinions', 'Online surveys were conducted of self-identified MG patients and MG physician experts about the importance of IS dose reduction for MG patients who achieve prolonged periods of disease stability']",[],['relapse rate'],"[{'cui': 'C0947912'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0871010', 'cui_str': 'Opinions'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0425945', 'cui_str': 'Prolonged periods (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",[],"[{'cui': 'C0035020', 'cui_str': 'Relapse'}]",45.0,0.025263,"Although both groups favored attempting IS reduction, they raised concerns including: MG relapse, hospitalization, and uncertainty about the future.","[{'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Hehir', 'Affiliation': 'The Robert Larner M.D. College of Medicine, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Anna Rostedt', 'Initials': 'AR', 'LastName': 'Punga', 'Affiliation': 'Department of Neuroscience Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Ciafaloni', 'Affiliation': 'University of Rochester School of Medicine, Rochester, New York, USA.'}]",Muscle & nerve,['10.1002/mus.26850']
759,32162931,Modeling the suicidal behavior cycle: Understanding repeated suicide attempts among individuals with borderline personality disorder and a history of attempting suicide.,"OBJECTIVE


Suicide remains a leading cause of death in the United States, and recent reports have suggested the suicide rate is increasing. One of the most robust predictors of future suicidal behavior is a history of attempting suicide. Despite this, little is known about the factors that reduce the likelihood of reattempting suicide. This study compares theoretically derived suicide risk indicators to determine which factors are most predictive of future suicide attempts.
METHOD


We used data from a randomized, controlled trial comparing 3 forms of dialectical behavior therapy (DBT; Linehan et al., 2015). Participants ( N  = 97, mean age = 30.3 years, 100% female, 71% White) met criteria for borderline personality disorder and had repeated and recent self-injurious behavior. Assessments occurred at 4-month intervals throughout 1 year of treatment and 1 year of follow-up. Time-lagged generalized linear mixed models (GLMMs) were used to evaluate relationship satisfaction, emotion dysregulation, and coping styles as predictors of suicide attempts.
RESULTS


Both univariate and multivariate models suggested that higher between-person variance in problem-focused coping and lack of access to emotion regulation strategies were weakly associated with additional suicide attempts over the 2-year study. Within-person variance in the time-lagged predictors was not associated with subsequent suicide attempts.
CONCLUSIONS


Among individuals with a recent suicide attempt, problem-focused coping and specific deficits in emotion regulation may differentiate those likely to reattempt from those who stop suicidal behavior during and after psychotherapy. These results suggest that treatments for recent suicide attempters should target increasing problem-focused coping and decreasing maladaptive emotion regulation skills. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Both univariate and multivariate models suggested that higher between-person variance in problem-focused coping and lack of access to emotion regulation strategies were weakly associated with additional suicide attempts over the 2-year study.,"['individuals with borderline personality disorder and a history of attempting suicide', 'Participants ( N  = 97, mean age = 30.3 years, 100% female, 71% White) met criteria for borderline personality disorder and had repeated and recent self-injurious behavior']",['dialectical behavior therapy'],"['relationship satisfaction, emotion dysregulation, and coping styles as predictors of suicide attempts']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0455507', 'cui_str': 'H/O: attempted suicide'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0085271', 'cui_str': 'Self-Injury'}]","[{'cui': 'C1321145', 'cui_str': 'Dialectical Behavior Therapy'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}]",,0.0736019,Both univariate and multivariate models suggested that higher between-person variance in problem-focused coping and lack of access to emotion regulation strategies were weakly associated with additional suicide attempts over the 2-year study.,"[{'ForeName': 'Kevin S', 'Initials': 'KS', 'LastName': 'Kuehn', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'King', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Marsha M', 'Initials': 'MM', 'LastName': 'Linehan', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Melanie S', 'Initials': 'MS', 'LastName': 'Harned', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000496']
760,32134286,Changes in externalizing and internalizing symptoms among African American female adolescents over 1 year following a mother-daughter sexual health intervention.,"OBJECTIVE


African American female adolescents face disparities compared with White peers in the interrelated areas of mental health symptoms and sexually transmitted infection (STI) acquisition. IMARA (Informed, Motivated, Aware and Responsible about AIDS) is a group-based mother-daughter intervention addressing these factors among African American teenagers. Previous work demonstrated that female adolescents who received IMARA were 43% less likely than controls to evidence a new STI at 1 year. This report aimed to provide the 1st test of IMARA on externalizing and internalizing symptoms and an exploratory analysis of whether symptom improvements were associated with the protective effect of treatment against future STIs.
METHOD


Female African Americans aged 14-18 years ( M  = 16;  N  = 199) were randomly assigned to IMARA or a health promotion control group matched for time and structure. They completed the Youth Self-Report of externalizing and internalizing symptoms at baseline and at 6 and 12 months and were tested for STIs at baseline and 12 months; positive cases were treated. Hierarchical linear modeling tested symptom change over time, including the moderating effects of baseline symptoms.
RESULTS


Among participants who entered with high versus lower externalizing symptoms, those who received IMARA showed a slightly greater decrease in externalizing scores relative to the control ( p  = .035). For these youth, symptom improvements appeared to be associated with IMARA's protective effect against new STIs. Treatment was not associated with internalizing symptom change ( p  > .05).
CONCLUSION


IMARA shows promise in modestly reducing self-reported externalizing symptoms, although only for participants with high scores at baseline. The possibility that externalizing symptom improvement is linked with reduced STI acquisition warrants future examination. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Treatment was not associated with internalizing symptom change ( p  > .05).
","['female adolescents', 'African American female adolescents', 'Female African Americans aged 14-18 years ( M  = 16;  N  = 199', 'African American teenagers']","['IMARA', 'IMARA or a health promotion control group matched for time and structure']","['Youth Self-Report of externalizing and internalizing symptoms', 'externalizing scores', 'externalizing and internalizing symptoms', 'internalizing symptom change']","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1521910', 'cui_str': 'Teens'}]","[{'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",199.0,0.0601317,"Treatment was not associated with internalizing symptom change ( p  > .05).
","[{'ForeName': 'Ashley D', 'Initials': 'AD', 'LastName': 'Kendall', 'Affiliation': 'Center for Dissemination and Implementation Science.'}, {'ForeName': 'Christina B', 'Initials': 'CB', 'LastName': 'Young', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Bethany C', 'Initials': 'BC', 'LastName': 'Bray', 'Affiliation': 'Center for Dissemination and Implementation Science.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Emerson', 'Affiliation': 'Center for Dissemination and Implementation Science.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Freels', 'Affiliation': 'Division of Epidemiology and Biostatistics.'}, {'ForeName': 'Geri R', 'Initials': 'GR', 'LastName': 'Donenberg', 'Affiliation': 'Center for Dissemination and Implementation Science.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000491']
761,32189165,A mobile terminal application program was used for endotracheal tube cuff pressure measurement.,"We studied the application of a mobile terminal application program in endotracheal tube (ETT) cuff pressure measurement to improve the implementation rate of scientific ETT cuff pressure measurement and to ensure that the pressure falls within the recommended range. A pre-post controlled study lasting for 18 months was undertaken in a 40-bed general intensive care unit (GICU). This included a 6-month baseline period (baseline group) and a 6-month intervention period (intervention group). The mobile terminal application program was applied to monitor the cuff pressure of endotracheal intubation as an intervention measure during the intervention period. ETT pressure was the main outcome measure, while gender, age, causes for ICU admission, sedation score, duration of prior intubation, size of ETT, and number of VAP patients were secondary outcomes. ETT cuff pressure was monitored 742 times in both the baseline group and the intervention group. A total of 56.9% of the cuff pressure measurements in the baseline group were within the recommended range, while 78.4% of measurements in the intervention group were within the recommended range, reflecting a statistically significant difference (P < 0.05). The application of the mobile terminal application program used for ETT cuff pressure measurement could improve the percentage of ETT cuff pressure measurements falling within the recommended range.",2020,We studied the application of a mobile terminal application program in endotracheal tube (ETT) cuff pressure measurement to improve the implementation rate of scientific ETT cuff pressure measurement and to ensure that the pressure falls within the recommended range.,['18\xa0months was undertaken in a 40-bed general intensive care unit (GICU'],['mobile terminal application program in endotracheal tube (ETT) cuff pressure measurement'],"['ETT cuff pressure', 'ICU admission, sedation score, duration of prior intubation, size of ETT, and number of VAP', 'cuff pressure measurements']","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0180212', 'cui_str': 'Endotracheal tube cuff, device (physical object)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",,0.0263321,We studied the application of a mobile terminal application program in endotracheal tube (ETT) cuff pressure measurement to improve the implementation rate of scientific ETT cuff pressure measurement and to ensure that the pressure falls within the recommended range.,"[{'ForeName': 'Wei-Zhong', 'Initials': 'WZ', 'LastName': 'Wang', 'Affiliation': ""Department of General Intensive Care Unit, Shaoxing People's Hospital, Zhongxing North Road, Shaoxing, 312000, Zhejiang, China. 906134210@qq.com.""}, {'ForeName': 'Yao-Ying', 'Initials': 'YY', 'LastName': 'Zhou', 'Affiliation': ""Department of General Intensive Care Unit, Shaoxing People's Hospital, Zhongxing North Road, Shaoxing, 312000, Zhejiang, China.""}, {'ForeName': 'Zhi-Juan', 'Initials': 'ZJ', 'LastName': 'Wang', 'Affiliation': ""Nursing Department, Shaoxing People's Hospital, Shaoxing, Zhejiang, China.""}, {'ForeName': 'Mei-Li', 'Initials': 'ML', 'LastName': 'Zhu', 'Affiliation': ""Nursing Department, Shaoxing People's Hospital, Shaoxing, Zhejiang, China.""}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Yao', 'Affiliation': ""Department of General Intensive Care Unit, Shaoxing People's Hospital, Zhongxing North Road, Shaoxing, 312000, Zhejiang, China.""}, {'ForeName': 'Jian-Di', 'Initials': 'JD', 'LastName': 'Yu', 'Affiliation': ""Department of General Intensive Care Unit, Shaoxing People's Hospital, Zhongxing North Road, Shaoxing, 312000, Zhejiang, China.""}, {'ForeName': 'Yan-Hong', 'Initials': 'YH', 'LastName': 'Lin', 'Affiliation': ""Department of General Intensive Care Unit, Shaoxing People's Hospital, Zhongxing North Road, Shaoxing, 312000, Zhejiang, China.""}, {'ForeName': 'Fei-Yun', 'Initials': 'FY', 'LastName': 'Yu', 'Affiliation': ""Department of General Intensive Care Unit, Shaoxing People's Hospital, Zhongxing North Road, Shaoxing, 312000, Zhejiang, China.""}, {'ForeName': 'Chun-Yan', 'Initials': 'CY', 'LastName': 'Wu', 'Affiliation': ""Department of General Intensive Care Unit, Shaoxing People's Hospital, Zhongxing North Road, Shaoxing, 312000, Zhejiang, China.""}, {'ForeName': 'Hui-Hui', 'Initials': 'HH', 'LastName': 'Zhang', 'Affiliation': ""Department of General Intensive Care Unit, Shaoxing People's Hospital, Zhongxing North Road, Shaoxing, 312000, Zhejiang, China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Lou', 'Affiliation': ""Department of General Intensive Care Unit, Shaoxing People's Hospital, Zhongxing North Road, Shaoxing, 312000, Zhejiang, China.""}, {'ForeName': 'Yue-Hong', 'Initials': 'YH', 'LastName': 'Hu', 'Affiliation': ""Department of General Intensive Care Unit, Shaoxing People's Hospital, Zhongxing North Road, Shaoxing, 312000, Zhejiang, China.""}]",Journal of clinical monitoring and computing,['10.1007/s10877-020-00499-7']
762,30772827,Adolescent males' responses to blu's fake warnings.,"OBJECTIVE


Blu's 'Something Better' advertising campaign ran in popular print magazines in 2017. The campaign included advertisements with fake warnings conveying positive messages, which mimicked the Food and Drug Administration (FDA)'s warning requirements for electronic cigarette (e-cigarette) advertisements that took effect in 2018. We report adolescent males' recall of these fake warnings and how exposure to fake warnings affected recall of other advertisement components, including the actual warning or health risks, brand and product.
METHODS


Ohio males ages 12-19 years (N = 775; 73.8 % white non-Hispanic) were randomly assigned to view an e-cigarette advertisement with or without a fake warning. Afterward, they were asked what they remembered most about the advertisement. Responses were qualitatively coded. Statistical analyses included survey-weighted descriptive statistics and logistic regression.
RESULTS


Of participants who viewed an e-cigarette advertisement with a fake warning, 27.0 % reported the fake warning was what they remembered most, and 18.8 % repeated the fake warning message. Participants viewing advertisements with a fake warning had lower odds of recalling the actual warning or health risks (OR = 0.29; 95% CI: 0.11 to 0.77) or brand (OR = 0.43; 95% CI: 0.22 to 0.85), compared with participants viewing other e-cigarette advertisements.
CONCLUSIONS


Adolescents viewing an advertisement with a fake warning were less likely to recall the advertisement's actual warning or health risks. Although e-cigarette advertisements now carry large FDA-mandated warnings, this tactic could be used for cigarette advertisements that continue to carry small warnings in the USA. Findings underscore the necessity of tobacco advertisement surveillance and study of advertisements' effects on adolescents.",2019,"Participants viewing advertisements with a fake warning had lower odds of recalling the actual warning or health risks (OR = 0.29; 95% CI: 0.11 to 0.77) or brand (OR = 0.43; 95% CI: 0.22 to 0.85), compared with participants viewing other e-cigarette advertisements.
","['adolescents', 'Ohio males ages 12-19 years (N = 775; 73.8 % white non-Hispanic']",['view an e-cigarette advertisement with or without a fake warning'],"['actual warning or health risks', 'fake warning']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517874', 'cui_str': '775'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}]","[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0241441,"Participants viewing advertisements with a fake warning had lower odds of recalling the actual warning or health risks (OR = 0.29; 95% CI: 0.11 to 0.77) or brand (OR = 0.43; 95% CI: 0.22 to 0.85), compared with participants viewing other e-cigarette advertisements.
","[{'ForeName': 'Brittney', 'Initials': 'B', 'LastName': 'Keller-Hamilton', 'Affiliation': 'Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, Ohio, USA keller-hamilton.1@osu.edu.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Roberts', 'Affiliation': 'Division of Health Behavior and Health Promotion, College of Public Health, The Ohio State University, Columbus, Ohio, United States.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Slater', 'Affiliation': 'School of Communication, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Micah', 'Initials': 'M', 'LastName': 'Berman', 'Affiliation': 'Division of Health Services Management and Policy, College of Public Health, The Ohio State University, Columbus, Ohio, United States.'}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Ferketich', 'Affiliation': 'Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, Ohio, USA.'}]",Tobacco control,['10.1136/tobaccocontrol-2018-054805']
763,32007513,"Serlopitant for psoriatic pruritus: A phase 2 randomized, double-blind, placebo-controlled clinical trial.","BACKGROUND


Pruritus, a common symptom of psoriasis, negatively affects quality of life; however, treatment of lesional skin does not consistently alleviate psoriatic itch.
OBJECTIVE


To examine the effects of serlopitant, an oral, once-daily neurokinin 1 receptor antagonist, for treatment of psoriatic pruritus in a phase 2, randomized clinical trial (NCT03343639).
METHODS


Patients (n = 204) were randomized to receive serlopitant, 5 mg, or placebo daily for 8 weeks. Eligible adult patients had plaque psoriasis for ≥6 months, plaques covering ≤10% of body surface area, pruritus for ≥4 weeks, and Worst Itch Numeric Rating Scale (WI-NRS) score ≥7 at the initial screening.
RESULTS


Participants (54.2% women) had a mean age of 47.5 years and 85.2% were white. Mean baseline WI-NRS scores were 8.3 for serlopitant and 8.1 for placebo. The WI-NRS 4-point response rate at 8 weeks (primary end point) was 33.3% for serlopitant vs 21.1% for placebo (P = .028); at 4 weeks the rates were 20.8% for serlopitant vs 11.5% for placebo (P = .039). Treatment-related adverse events were reported for 4.9% of serlopitant-treated and 4.0% of placebo-treated patients.
LIMITATIONS


This was a phase 2 study with a small study population. Patients with severe psoriasis were excluded.
CONCLUSION


Serlopitant significantly reduced pruritus associated with mild to moderate psoriasis, supporting continued development of serlopitant for this patient population.",2020,"Treatment-related adverse events were reported for 4.9% and 4.0% of serlopitant and placebo-treated patients, respectively.
","['Patients with severe psoriasis were excluded', 'Mean age was 47.5 years, 54.2% female, and 85.2% white', 'Patients (n=204', 'Eligible adult patients had plaque psoriasis ≥6 months, plaques covering ≤10% of body surface area, pruritus ≥4 weeks, and worst itch numeric rating scale (WI-NRS) score ≥7 at initial screening', 'Psoriatic Pruritus']","['Placebo', 'placebo', 'serlopitant 5 mg or placebo']","['Mean baseline WI-NRS scores', 'WI-NRS 4-point response rate', 'adverse events', 'pruritus']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517808', 'cui_str': '54.2 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2825662', 'cui_str': 'serlopitant'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}]",204.0,0.659288,"Treatment-related adverse events were reported for 4.9% and 4.0% of serlopitant and placebo-treated patients, respectively.
","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Pariser', 'Affiliation': 'Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research, Inc, Norfolk, Virginia.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Bagel', 'Affiliation': 'Psoriasis Treatment Center of Central New Jersey, East Windsor, New Jersey.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Yosipovitch', 'Affiliation': 'Miami Itch Center, Department of Dermatology, University of Miami, Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Chien', 'Affiliation': 'Independent Contractor, Palo Alto, California.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Spellman', 'Affiliation': 'Menlo Therapeutics, Inc, Redwood City, California. Electronic address: mspellman@comcast.net.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.01.056']
764,32185745,Repository Corticotropin Injection for Active Rheumatoid Arthritis Despite Aggressive Treatment: A Randomized Controlled Withdrawal Trial.,"INTRODUCTION


The objective of this study was to assess efficacy and safety of repository corticotropin injection (RCI) in subjects with active rheumatoid arthritis (RA) despite treatment with a corticosteroid and one or two disease-modifying antirheumatic drugs (DMARDs).
METHODS


All subjects received open-label RCI (80 U) twice weekly for 12 weeks (part 1); only those with low disease activity [LDA; i.e., Disease Activity Score 28 joint count and erythrocyte sedimentation rate (DAS28-ESR) < 3.2] were randomly assigned to receive either RCI (80 U) or placebo twice weekly during the 12-week double-blind period (part 2). The primary efficacy endpoint was the proportion of subjects who achieved LDA at week 12. Secondary efficacy endpoints included proportions of subjects who maintained LDA during weeks 12 through 24 and achieved Clinical Disease Activity Index (CDAI) ≤ 10 at weeks 12 and 24. Safety was assessed via adverse event reports.
RESULTS


Of the 259 enrolled subjects, 235 completed part 1; 154 subjects (n = 77 each for RCI and placebo) entered part 2, and 127 (RCI, n = 71; placebo, n = 56) completed. At week 12, 163 subjects (62.9%) achieved LDA and 169 (65.3%) achieved CDAI ≤ 10 (both p < 0.0001). At week 24, 47 (61.0%) RCI-treated and 32 (42.1%) placebo-treated subjects maintained LDA (p = 0.019); 66 (85.7%) RCI-treated and 50 (65.8%) placebo-treated subjects maintained CDAI ≤ 10 (p = 0.004). No unexpected safety signals were observed.
CONCLUSIONS


RCI was effective and generally safe in patients with active RA despite corticosteroid/DMARD therapy. By week 12, > 60% of patients achieved LDA, which was maintained with 12 additional weeks of treatment. Most patients who achieved LDA maintained it for 3 months after RCI discontinuation.
TRIAL REGISTRATION


Clinicaltrials.gov identifier NCT02919761.",2020,"No unexpected safety signals were observed.
","['subjects with active rheumatoid arthritis (RA) despite treatment with a corticosteroid and one or two disease-modifying antirheumatic drugs (DMARDs', 'Active Rheumatoid Arthritis', 'patients with active RA despite corticosteroid/DMARD therapy', '259 enrolled subjects, 235 completed part 1; 154 subjects (n\u2009=\u200977 each for RCI and']","['repository corticotropin injection (RCI', 'placebo', 'open-label RCI', 'Repository Corticotropin Injection', 'RCI']","['proportion of subjects who achieved LDA', 'Clinical Disease Activity Index (CDAI', 'efficacy and safety', 'proportions of subjects who maintained LDA', 'LDA']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0201835', 'cui_str': 'Adrenocorticotropic hormone measurement (procedure)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}]",259.0,0.441859,"No unexpected safety signals were observed.
","[{'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Fleischmann', 'Affiliation': 'University of Texas Southwestern Medical Center, Metroplex Clinical Research Center, 8144 Walnut Hill Lane, Suite 810, Dallas, TX, 75231, USA. rfleischmann@arthdocs.com.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Furst', 'Affiliation': 'Division of Rheumatology, David Geffen School of Medicine, University of California Los Angeles, Peter Morton Medical Building, 200, UCLA Medical Plaza, Suite 365-B, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Connolly-Strong', 'Affiliation': 'Mallinckrodt Pharmaceuticals, 1425 US-206, Bedminster, NJ, 07921, USA.'}, {'ForeName': 'Jingyu', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Mallinckrodt Pharmaceuticals, 1425 US-206, Bedminster, NJ, 07921, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Mallinckrodt Pharmaceuticals, 1425 US-206, Bedminster, NJ, 07921, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Brasington', 'Affiliation': 'Division of Rheumatology, Washington University School of Medicine, 4921 Parkview Place, Suite C, 5th Floor, St. Louis, MO, 63110, USA.'}]",Rheumatology and therapy,['10.1007/s40744-020-00199-3']
765,32176565,Omega 3 Supplementation Can Regulate Inflammatory States in Gas Station Workers: A Double-Blind Placebo-Controlled Clinical Trial.,"Environmental exposure to diesel particulate matter and commercial gasoline in gas station workers might induce oxidative stress and changes in the balance of the immune system. In this study, the immunomodulatory impacts of omega 3 fatty acid (ω3FA) supplement were assessed on inflammatory and anti-inflammatory markers in gas station workers in a double-blind placebo-controlled clinical trial. Fifty-three men working in gas stations were treated with ω3FA ( n  = 29) or placebo ( n  = 24) for 60 days. C-reactive protein, interleukin-12 (IL-12), transforming growth factor β (TGF-β), interferon γ (IFN-γ), tumor necrosis factor α, IL-10, and IL-17 levels were measured by enzyme-linked immunosorbent assay method before and after the completion of the trial. The concentrations of IFN-γ and IL-17 were significantly decreased in ω3FA group compared with the placebo group ( P  < 0.001). Moreover, the levels of inhibitory cytokines including TGF-β and IL-10 significantly were increased in ω3FA group ( P  < 0.001). Overall, ω3FA nutritional supplementation can be useful in reducing inflammatory immune responses and maintaining immune tolerance in people with high exposure to inflammation-inducing factors. [Figure: see text].",2020,The concentrations of IFN-γ and IL-17 were significantly decreased in ω3FA group compared with the placebo group ( P  < 0.001).,"['Fifty-three men working in gas stations', 'Gas Station Workers', 'people with high exposure to inflammation-inducing factors']","['omega 3 fatty acid (ω3FA) supplement', 'placebo', 'Environmental exposure to diesel particulate matter and commercial gasoline', 'ω3FA', 'Placebo']","['inflammatory and anti-inflammatory markers', 'levels of inhibitory cytokines including TGF-β and IL-10', 'α, IL-10, and IL-17 levels', 'C-reactive protein, interleukin-12 (IL-12), transforming growth factor β (TGF-β), interferon γ (IFN-γ), tumor necrosis factor', 'concentrations of IFN-γ and IL-17']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0562311', 'cui_str': 'Petrol station'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0014412', 'cui_str': 'Environmental Exposure'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C0017113', 'cui_str': 'Gasoline'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0384648', 'cui_str': 'IL-17'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0040691', 'cui_str': 'Animal growth regulators, transforming growth factors'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",53.0,0.436733,The concentrations of IFN-γ and IL-17 were significantly decreased in ω3FA group compared with the placebo group ( P  < 0.001).,"[{'ForeName': 'Shoresh', 'Initials': 'S', 'LastName': 'Barkhordari', 'Affiliation': 'Student Research Committee, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Mirmosayyeb', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Mansourian', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Hosseininasab', 'Affiliation': 'Department of Immunology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Saba', 'Initials': 'S', 'LastName': 'Ramezani', 'Affiliation': 'Student Research Committee, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Barzegar', 'Affiliation': 'Student Research Committee, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad Mehdi', 'Initials': 'MM', 'LastName': 'Amin', 'Affiliation': 'Environment Research Center, Research Institute for Primordial Prevention of Non-Communicable Disease, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Parinaz', 'Initials': 'P', 'LastName': 'Poursafa', 'Affiliation': 'Environment Research Center, Research Institute for Primordial Prevention of Non-Communicable Disease, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Nafiseh', 'Initials': 'N', 'LastName': 'Esmaeil', 'Affiliation': 'Environment Research Center, Research Institute for Primordial Prevention of Non-Communicable Disease, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Kelishadi', 'Affiliation': 'Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-communicable Disease, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of interferon & cytokine research : the official journal of the International Society for Interferon and Cytokine Research,['10.1089/jir.2019.0220']
766,32053221,Effect of tongue-strengthening training combined with a tablet personal computer game in healthy adults.,"BACKGROUND


Game-based training has been shown to improve behavioural motor learning in various medical fields including rehabilitation.
OBJECTIVES


This study aimed to investigate the effects of a tablet PC (personal computer) game-based tongue training on tongue strength, thickness and compliance in healthy adults.
METHODS


This study recruited 30 healthy volunteers. Subjects were randomly assigned to two groups (n = 15/group). Group 1 performed game-based tongue training, and group 2 performed tongue resistance training using the Iowa Oral Performance Instrument. Both groups performed the same tongue exercises as follows: frequency (isotonic = 30 times × 3, isometric = 20 seconds × 3), intensity (70% of 1-repeated maximum contraction) and intervention period (5 days for 6 weeks). The primary outcomes were tongue muscle strength and thickness. Secondary outcomes were assessed using a 0-to-10 numerical rating self-report scale that included motivation, interest/fun, physical effort and muscle fatigue/pain.
RESULTS


Both groups showed significant improvement in tongue strength and thickness, but there were no significant differences between the groups after the intervention. The self-report scale numerical rating revealed that group 1 had significantly higher motivation and interest/fun after the exercise than group 2. Group 1 had expended a significantly lower physical effort than group 2. No significant differences were noted between the 2 groups for muscle fatigue/pain.
CONCLUSION


This study showed that both exercises had similar effects on tongue strength and thickness increase in healthy adults, but game-based tongue training was more fun and physically less demanding.",2020,"Both groups showed significant improvement in tongue strength and thickness, but there were no significant differences between the groups after the intervention.","['30 healthy volunteers', 'healthy adults']","['tongue-strengthening\xa0training combined with a tablet personal computer game', 'tablet PC (personal computer) game-based tongue training', 'game-based tongue training, and group 2 performed tongue resistance training using the Iowa Oral Performance Instrument']","['tongue strength and thickness increase', 'tongue strength, thickness, and compliance', 'tongue muscle strength and thickness', 'muscle fatigue/pain', 'tongue strength and thickness', '0-to-10 numerical rating self-report scale that included motivation, interest/fun, physical effort, and muscle fatigue/pain']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0162419', 'cui_str': 'Personal Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242979', 'cui_str': 'Muscular Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0031807', 'cui_str': 'Physical Effort'}]",30.0,0.019624,"Both groups showed significant improvement in tongue strength and thickness, but there were no significant differences between the groups after the intervention.","[{'ForeName': 'Na-Kyoung', 'Initials': 'NK', 'LastName': 'Hwang', 'Affiliation': 'Department of Occupational Therapy, Seoul North Municipal Hospital, Seoul, Korea.'}, {'ForeName': 'Min-Ji', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Division of Health Sciences, Department of Dental Hygiene, DongSeo University, Busan, Korea.'}, {'ForeName': 'Gihyoun', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Taehyung', 'Initials': 'T', 'LastName': 'Yoon', 'Affiliation': 'Division of Health Sciences, Department of Occupational Therapy, Dongseo University, Seoul, Korea.'}, {'ForeName': 'Ji-Su', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Advanced Human Resource Development Project Group for Health Care in Aging Friendly Industry, Dongseo University, Busan, Korea.'}, {'ForeName': 'YoungJin', 'Initials': 'Y', 'LastName': 'Jung', 'Affiliation': 'Advanced Human Resource Development Project Group for Health Care in Aging Friendly Industry, Dongseo University, Busan, Korea.'}]",Journal of oral rehabilitation,['10.1111/joor.12944']
767,32068049,"Efficacy and safety of topical sofpironium bromide gel for the treatment of axillary hyperhidrosis: A phase II, randomized, controlled, double-blinded trial.","BACKGROUND


Primary axillary hyperhidrosis has limited noninvasive, effective, and well-tolerated treatment options.
OBJECTIVE


To evaluate the topical treatment of axillary hyperhidrosis with the novel anticholinergic sofpironium bromide.
METHODS


A phase II, multicenter, randomized, controlled, double-blinded study. Participants were randomized to 1 of 3 dosages or vehicle, with daily treatment for 42 days. Coprimary end points were the percentage of participants exhibiting ≥1-point improvement in the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) score by logistic regression, and change in HDSM-Ax as a continuous measure by analysis of covariance. Pair-wise comparisons were 1-sided with α = 0.10.
RESULTS


At the end of therapy, 70%, 79%, 76%, and 54% of participants in the 5%, 10%, 15%, and vehicle groups exhibited ≥1-point improvement in HDSM-Ax (P < .05). Least-square mean (SE) changes in HDSM-Ax were -2.02 (0.14), -2.09 (0.14), 2.10 (0.14), and -1.30 (0.14) (all P ≤ .0001). Most treatment-related adverse events were mild or moderate.
LIMITATIONS


Not powered to detect changes in gravimetric sweat production.
CONCLUSION


Sofpironium bromide gel produced meaningful reductions in hyperhidrosis severity and had an acceptable safety profile.",2020,"Most treatment-related adverse events were mild or moderate.
",['Axillary Hyperhidrosis'],"['Topical Sofpironium Bromide Gel', 'Sofpironium bromide gel']","['Efficacy and Safety', 'Least-square mean (SE) changes in HDSM-Ax', 'percentage of participants exhibiting ≥1-point improvement in Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax; logistic regression), and change in HDSM-Ax as a continuous measure (ANCOVA']","[{'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0006222', 'cui_str': 'Bromides'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C0206031', 'cui_str': 'Logistic Regression'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]",,0.324402,"Most treatment-related adverse events were mild or moderate.
","[{'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Kirsch', 'Affiliation': 'Brickell Biotech, Inc, Boulder, Colorado.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'California Dermatology and Clinical Research Institute, Encinitas, California.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Cohen', 'Affiliation': 'AboutSkin Dermatology and DermSurgery, Greenwood Village, Colorado; Department of Dermatology, University of California, Irvine, California.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'DuBois', 'Affiliation': 'DermResearch Inc, Austin, Texas.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Green', 'Affiliation': 'Department of Dermatology, George Washington University School of Medicine, Washington, DC.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Baumann', 'Affiliation': 'Baumann Cosmetic and Research Institute, Miami, Florida.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Bhatia', 'Affiliation': 'Therapeutics Clinical Research, San Diego, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pariser', 'Affiliation': 'Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research, Inc, Norfolk, Virginia.'}, {'ForeName': 'Ping-Yu', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Chadha', 'Affiliation': 'Brickell Biotech, Inc, Boulder, Colorado. Electronic address: dchadha@brickellbio.com.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Walker', 'Affiliation': 'Brickell Biotech, Inc, Boulder, Colorado.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.02.016']
768,31477558,Aspirin as an adjuvant treatment for cancer: feasibility results from the Add-Aspirin randomised trial.,"BACKGROUND


Preclinical, epidemiological, and randomised data indicate that aspirin might prevent tumour development and metastasis, leading to reduced cancer mortality, particularly for gastro-oesophageal and colorectal cancer. Randomised trials evaluating aspirin use after primary radical therapy are ongoing. We present the pre-planned feasibility analysis of the run-in phase of the Add-Aspirin trial to address concerns about toxicity, particularly bleeding after radical treatment for gastro-oesophageal cancer.
METHODS


The Add-Aspirin protocol includes four phase 3 randomised controlled trials evaluating the effect of daily aspirin on recurrence and survival after radical cancer therapy in four tumour cohorts: gastro-oesophageal, colorectal, breast, and prostate cancer. An open-label run-in phase (aspirin 100 mg daily for 8 weeks) precedes double-blind randomisation (for participants aged under 75 years, aspirin 300 mg, aspirin 100 mg, or matched placebo in a 1:1:1 ratio; for patients aged 75 years or older, aspirin 100 mg or matched placebo in a 2:1 ratio). A preplanned analysis of feasibility, including recruitment rate, adherence, and toxicity was performed. The trial is registered with the International Standard Randomised Controlled Trials Number registry (ISRCTN74358648) and remains open to recruitment.
FINDINGS


After 2 years of recruitment (October, 2015, to October, 2017), 3494 participants were registered (115 in the gastro-oesophageal cancer cohort, 950 in the colorectal cancer cohort, 1675 in the breast cancer cohort, and 754 in the prostate cancer cohort); 2719 (85%) of 3194 participants who had finished the run-in period proceeded to randomisation, with rates consistent across tumour cohorts. End of run-in data were available for 2253 patients; 2148 (95%) of the participants took six or seven tablets per week. 11 (0·5%) of the 2253 participants reported grade 3 toxicity during the run-in period, with no upper gastrointestinal bleeding (any grade) in the gastro-oesophageal cancer cohort. The most frequent grade 1-2 toxicity overall was dyspepsia (246 [11%] of 2253 participants).
INTERPRETATION


Aspirin is well-tolerated after radical cancer therapy. Toxicity has been low and there is no evidence of a difference in adherence, acceptance of randomisation, or toxicity between the different cancer cohorts. Trial recruitment continues to determine whether aspirin could offer a potential low cost and well tolerated therapy to improve cancer outcomes.
FUNDING


Cancer Research UK, The National Institute for Health Research Health Technology Assessment Programme, The MRC Clinical Trials Unit at UCL.",2019,"Toxicity has been low and there is no evidence of a difference in adherence, acceptance of randomisation, or toxicity between the different cancer cohorts.","['gastro-oesophageal cancer', '11', '3494 participants were registered (115 in the gastro-oesophageal cancer cohort, 950 in the colorectal cancer cohort, 1675 in the breast cancer cohort, and 754 in the prostate cancer cohort); 2719 (85%) of 3194 participants who had finished the run-in period proceeded to randomisation, with rates consistent across tumour cohorts', '2253 patients; 2148 (95%) of the participants took six or seven tablets per week', 'patients aged 75 years or older', 'cancer', 'after radical cancer therapy in four tumour cohorts: gastro-oesophageal, colorectal, breast, and prostate cancer']","['aspirin', 'Aspirin', 'aspirin 100 mg or matched placebo', 'open-label run-in phase (aspirin', 'aspirin 300 mg, aspirin 100 mg, or matched placebo']","['grade 3 toxicity', 'recruitment rate, adherence, and toxicity', 'adherence, acceptance of randomisation, or toxicity', 'recurrence and survival']","[{'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0303407', 'cui_str': 'In-115 radioisotope'}, {'cui': 'C4708800', 'cui_str': '950'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1124475', 'cui_str': 'Aspirin 100 MG'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0983862', 'cui_str': 'Aspirin 300 MG'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",2253.0,0.432177,"Toxicity has been low and there is no evidence of a difference in adherence, acceptance of randomisation, or toxicity between the different cancer cohorts.","[{'ForeName': 'Nalinie', 'Initials': 'N', 'LastName': 'Joharatnam-Hogan', 'Affiliation': 'MRC Clinical Trials Unit, University College London, UK.'}, {'ForeName': 'Fay', 'Initials': 'F', 'LastName': 'Cafferty', 'Affiliation': 'MRC Clinical Trials Unit, University College London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hubner', 'Affiliation': 'The Christie Hospital, Manchester, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Swinson', 'Affiliation': 'St James University Hospital, Leeds, UK.'}, {'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Sothi', 'Affiliation': 'University Hospital Coventry and Warwickshire, UK.'}, {'ForeName': 'Kamalnayan', 'Initials': 'K', 'LastName': 'Gupta', 'Affiliation': 'Worcestershire Royal Hospital, Worcester, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'Bristol Haematology & Oncology Centre, Bristol, UK.'}, {'ForeName': 'Kinnari', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Warner', 'Affiliation': 'Stoke Mandeville Hospital, Aylesbury, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Kunene', 'Affiliation': 'Manor Hospital, Walsall, UK.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Rowley', 'Affiliation': 'MRC Clinical Trials Unit, University College London, UK.'}, {'ForeName': 'Komel', 'Initials': 'K', 'LastName': 'Khabra', 'Affiliation': 'MRC Clinical Trials Unit, University College London, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Underwood', 'Affiliation': 'University of Southampton, Southampton, UK.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Jankowski', 'Affiliation': 'Gastroenterology Unit, Morecambe Bay University Hospitals NHS Trust, UK; National Institute for Health and Care Excellence, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'University College Hospital London, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Crossley', 'Affiliation': 'St James University Hospital, Leeds, UK.'}, {'ForeName': 'Verity', 'Initials': 'V', 'LastName': 'Henson', 'Affiliation': 'Bristol Haematology & Oncology Centre, Bristol, UK.'}, {'ForeName': 'Lindy', 'Initials': 'L', 'LastName': 'Berkman', 'Affiliation': 'NCRI Consumer Liaison Group, London, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Gilbert', 'Affiliation': 'MRC Clinical Trials Unit, University College London, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Kynaston', 'Affiliation': 'Cardiff University, Cardiff, UK.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Ring', 'Affiliation': 'Royal Marsden Hospital, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cameron', 'Affiliation': 'Cancer Research UK Edinburgh Centre, MRC Institute of Genetics & Molecular Medicine, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Farhat', 'Initials': 'F', 'LastName': 'Din', 'Affiliation': 'Cancer Research UK Edinburgh Centre, MRC Institute of Genetics & Molecular Medicine, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Graham', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Iveson', 'Affiliation': 'Southampton General Hospital, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Adams', 'Affiliation': 'Velindre Cancer Centre, Cardiff, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': 'Leicester Royal Infirmary, Leicester, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Pramesh', 'Affiliation': 'Department of Surgical Oncology, Tata Memorial Hospital, Mumbai, India.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Langley', 'Affiliation': 'MRC Clinical Trials Unit, University College London, UK. Electronic address: ruth.langley@ucl.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30289-4']
769,30569038,"A novel nano-iron supplement to safely combat iron deficiency and anaemia in young children: The IHAT-GUT double-blind, randomised, placebo-controlled trial protocol.","Background:  Iron deficiency and its associated anaemia (IDA) are the leading forms of micronutrient malnutrition worldwide. Here we describe the rationale and design of the first clinical trial evaluating the efficacy and safety of an innovative nano iron supplement, iron hydroxide adipate tartrate (IHAT), for the treatment of IDA in young children (IHAT-GUT trial). Oral iron is often ineffective due to poor absorption and/or gastrointestinal adverse effects. IHAT is novel since it is effectively absorbed whilst remaining nanoparticulate in the gut, therefore should enable supplementation with fewer symptoms.  Methods:  IHAT-GUT is a three-arm, double-blind, randomised, placebo-controlled phase II trial conducted in Gambian children 6-35 months of age. The intervention consists of a 12-week supplementation with either IHAT, ferrous sulphate (both at doses bioequivalent to 12.5 mg  Fe /day) or placebo. The trial aims to include 705 children with IDA who will be randomly assigned (1:1:1) to each arm. The primary objectives are to test non-inferiority of IHAT in relation to ferrous sulphate at treating IDA, and to test superiority of IHAT in relation to ferrous sulphate and non-inferiority in relation to placebo in terms of diarrhoea incidence and prevalence. Secondary objectives are mechanistic assessments, to test whether IHAT reduces the burden of enteric pathogens, morbidity, and intestinal inflammation, and that it does not cause detrimental changes to the gut microbiome, particularly in relation to  Lactobacillaceae ,  Bifidobacteriaceae  and  Enterobacteriaceae .  Discussion:  This trial will test the hypothesis that supplementation with IHAT eliminates iron deficiency and improves haemoglobin levels without inducing gastrointestinal adverse effects. If shown to be the case, this would open the possibility for further testing and use of IHAT as a novel iron source for micronutrient intervention strategies in resource-poor countries, with the ultimate aim to help reduce the IDA global burden.  Registration:  This trial is registered at clinicaltrials.gov ( NCT02941081).",2018,This trial will test the hypothesis that supplementation with IHAT eliminates iron deficiency and improves haemoglobin levels without inducing gastrointestinal adverse effects.,"['Gambian children 6-35 months of age', 'young children', 'young children (IHAT-GUT trial', '705 children with IDA']","['placebo', 'innovative nano iron supplement, iron hydroxide adipate tartrate (IHAT', 'IHAT, ferrous sulphate', 'novel nano-iron supplement', 'IHAT']","['haemoglobin levels', 'diarrhoea incidence and prevalence', 'burden of enteric pathogens, morbidity, and intestinal inflammation', 'efficacy and safety']","[{'cui': 'C0337833', 'cui_str': 'Gambians (ethnic group)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0721124', 'cui_str': 'Iron supplement (substance)'}, {'cui': 'C0060236', 'cui_str': 'ferric hydroxide'}, {'cui': 'C0050846', 'cui_str': 'adipic acid'}, {'cui': 'C0144544', 'cui_str': 'tartrate'}, {'cui': 'C0060282', 'cui_str': 'ferrous sulfate'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C3889047', 'cui_str': 'Intestinal inflammation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",705.0,0.617394,This trial will test the hypothesis that supplementation with IHAT eliminates iron deficiency and improves haemoglobin levels without inducing gastrointestinal adverse effects.,"[{'ForeName': 'Dora I A', 'Initials': 'DIA', 'LastName': 'Pereira', 'Affiliation': 'Department of Pathology, University of Cambridge, Cambridge, CB2 1QP, UK.'}, {'ForeName': 'Nuredin I', 'Initials': 'NI', 'LastName': 'Mohammed', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'Ogochukwu', 'Initials': 'O', 'LastName': 'Ofordile', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'Famalang', 'Initials': 'F', 'LastName': 'Camara', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'Bakary', 'Initials': 'B', 'LastName': 'Baldeh', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mendy', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'Chilel', 'Initials': 'C', 'LastName': 'Sanyang', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'Amadou T', 'Initials': 'AT', 'LastName': 'Jallow', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'Ilias', 'Initials': 'I', 'LastName': 'Hossain', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wason', 'Affiliation': 'MRC Biostatistics Unit, Institute of Public Health, University of Cambridge, Cambridge, CB2 0SR, UK.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Prentice', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}]",Gates open research,['10.12688/gatesopenres.12866.2']
770,32180164,"Comparative Responses in Lung Function Measurements with Tiotropium in Adolescents and Adults, and Across Asthma Severities: A Post Hoc Analysis.","INTRODUCTION


Airway obstruction is usually assessed by measuring forced expiratory volume in 1 s (FEV 1 ), forced vital capacity (FVC) and peak expiratory flow (PEF). This post hoc study investigated comparative responses of lung function measurements in adults and adolescents (full analysis set, N = 3873) following treatment with tiotropium Respimat ® .
METHODS


Lung function outcomes were analysed from five phase III trials in adults (≥ 18 years) with symptomatic severe, moderate and mild asthma (PrimoTinA-asthma ® , MezzoTinA-asthma ®  and GraziaTinA-asthma ® , respectively), and one phase III trial in adolescents (12-17 years) with symptomatic moderate asthma (RubaTinA-asthma ® ). Changes from baseline versus placebo in FEV 1 , FVC, PEF and FEV 1 /FVC ratio with tiotropium 5 µg or 2.5 µg added to at least stable inhaled corticosteroids at week 24 (week 12 in GraziaTinA-asthma) were analysed.
RESULTS


All lung function measures improved in all studies with tiotropium 5 µg (mean change from baseline versus placebo), including peak FEV 1  (110-185 mL), peak FVC (57-95 mL) and morning PEF (15.8-25.6 L/min). Changes in adolescents were smaller than those in adults, and were statistically significant primarily for FEV 1  and PEF, but not for FVC.
CONCLUSION


Consistent improvements were seen across all lung function measures with the addition of tiotropium to other asthma treatments in adults across all severities, whereas the improvements with tiotropium in adolescents primarily impacted measures of flow rather than lung volume. This may reflect less pronounced airway remodelling and air trapping in adolescents with asthma versus adults.",2020,"All lung function measures improved in all studies with tiotropium 5 µg (mean change from baseline versus placebo), including peak FEV 1  (110-185 mL), peak FVC (57-95 mL) and morning PEF (15.8-25.6 L/min).","['Lung function outcomes were analysed from five phase III trials in adults (≥\u200918\xa0years) with symptomatic severe, moderate and mild asthma (PrimoTinA-asthma ® , MezzoTinA-asthma ®  and GraziaTinA-asthma ® , respectively), and one phase III trial in adolescents (12-17\xa0years) with symptomatic moderate asthma (RubaTinA-asthma ® ', 'adolescents with asthma versus adults', 'adults and adolescents (full analysis set, N\u2009=\u20093873) following treatment with', 'Adolescents and Adults, and Across Asthma Severities']","['placebo', 'Tiotropium', 'tiotropium Respimat ® ', 'tiotropium']","['peak FVC', 'All lung function measures', 'forced vital capacity (FVC) and peak expiratory flow (PEF']","[{'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0581125', 'cui_str': 'Moderate asthma'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0581122', 'cui_str': 'Asthma severity (regime/therapy)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}]",,0.0693147,"All lung function measures improved in all studies with tiotropium 5 µg (mean change from baseline versus placebo), including peak FEV 1  (110-185 mL), peak FVC (57-95 mL) and morning PEF (15.8-25.6 L/min).","[{'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK. d.halpin@nhs.net.'}, {'ForeName': 'Eckard H', 'Initials': 'EH', 'LastName': 'Hamelmann', 'Affiliation': 'Evangelisches Klinikum Bethel, Bielefeld, Germany.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Frith', 'Affiliation': 'Respiratory Medicine, Flinders University College of Medicine and Public Health, Adelaide, SA, Australia.'}, {'ForeName': 'Petra M', 'Initials': 'PM', 'LastName': 'Moroni-Zentgraf', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'van Hecke', 'Affiliation': 'Boehringer Ingelheim Pty. Ltd., Sydney, NSW, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Unseld', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.'}, {'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'Department of Pulmonology and Tuberculosis, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': ""The Breathing Institute, Children's Hospital Colorado, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO, USA.""}]",Pulmonary therapy,['10.1007/s41030-020-00113-w']
771,32173063,[Short term olfactory memory and olfactory function after inhalation anesthetic agents: a randomized clinical trial].,"BACKGROUND AND OBJECTIVES


This clinical trial aimed to evaluate the effects of two different inhalation anesthetic agents on postoperative olfactory memory and olfactory function in patients who underwent micro laryngeal surgery.
METHODS


This randomized prospective controlled study consisted of 102 consecutive patients with a voice disorder. The patients underwent micro laryngeal surgery for voice disorders under general anesthesia. Patients who did not meet inclusion criteria and/or declined to participate (n=34) were excluded from the study. Patients were divided into two groups. Four patients from Group 1 and four patients from Group 2 were lost to follow-up. Group 1 (n=30) received sevoflurane, and Group 2 (n=30) received desflurane during anesthesia. We compared the results by performing the pre-op and post-op Connecticut Chemosensory Clinical Research Center Olfactory test.
RESULTS


Thirty-three patients (55%) were male and 27 (45%) were female. The mean age was 48.18±13.88 years (range: 19-70 years). Preoperative and postoperative olfactory functions did not show a significant difference within the groups postoperatively (p> 0.05). Preoperative and postoperative olfactory memory showed a significant decrease 3hours after the surgery (p <0.05).
CONCLUSIONS


Olfactory functions and memory were not affected by desflurane in the early postoperative period. Although sevoflurane did not affect olfactory functions, it had a temporary negative effect on olfactory memory in the early postoperative period.",2020,Preoperative and postoperative olfactory functions did not show a significant difference within the groups postoperatively (p> 0.05).,"['Patients who did not meet inclusion criteria and/or declined to participate (n=34) were excluded from the study', 'The mean age was 48.18±13.88\xa0years (range:\xa019-70\xa0years', '102\xa0consecutive patients with a voice disorder', 'patients who underwent micro laryngeal surgery', 'Thirty-three patients (55%) were male and 27\xa0(45%) were female', 'voice disorders under general anesthesia']","['micro laryngeal surgery', 'desflurane', 'sevoflurane', 'desflurane during anesthesia', 'inhalation anesthetic agents']","['postoperative olfactory memory and olfactory function', 'olfactory memory', 'Preoperative and postoperative olfactory memory', 'Preoperative and postoperative olfactory functions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0042940', 'cui_str': 'Voice Disorders'}, {'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0242903', 'cui_str': 'Anesthetics, Inhalation'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439826', 'cui_str': 'Olfactory (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]",,0.0629067,Preoperative and postoperative olfactory functions did not show a significant difference within the groups postoperatively (p> 0.05).,"[{'ForeName': 'Huseyin', 'Initials': 'H', 'LastName': 'Sari', 'Affiliation': 'Okmeydanı Training and Research Hospital, Department of\xa0Otorhinolaryngology-Head and Neck Surgery, Istambul, Turquia. Electronic address: drhuseyinsari@gmail.com.'}, {'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Atar', 'Affiliation': 'Okmeydanı Training and Research Hospital, Department of\xa0Otorhinolaryngology-Head and Neck Surgery, Istambul, Turquia.'}, {'ForeName': 'Tarkan', 'Initials': 'T', 'LastName': 'Mingir', 'Affiliation': 'Okmeydanı Training and Research Hospital, Department of\xa0Anesthesiology, Istambul, Turquia.'}, {'ForeName': 'Tolgar Lutfi', 'Initials': 'TL', 'LastName': 'Kumral', 'Affiliation': 'Okmeydanı Training and Research Hospital, Department of\xa0Otorhinolaryngology-Head and Neck Surgery, Istambul, Turquia.'}, {'ForeName': 'Muhammed Fatih', 'Initials': 'MF', 'LastName': 'Akgun', 'Affiliation': 'Okmeydanı Training and Research Hospital, Department of\xa0Otorhinolaryngology-Head and Neck Surgery, Istambul, Turquia.'}, {'ForeName': 'Esmail Abdulahi', 'Initials': 'EA', 'LastName': 'Ahmed', 'Affiliation': 'Okmeydanı Training and Research Hospital, Department of\xa0Otorhinolaryngology-Head and Neck Surgery, Istambul, Turquia.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Aydogdu', 'Affiliation': 'Okmeydanı Training and Research Hospital, Department of\xa0Otorhinolaryngology-Head and Neck Surgery, Istambul, Turquia.'}, {'ForeName': 'Ziya', 'Initials': 'Z', 'LastName': 'Salturk', 'Affiliation': 'Okmeydanı Training and Research Hospital, Department of\xa0Otorhinolaryngology-Head and Neck Surgery, Istambul, Turquia.'}, {'ForeName': 'Guler', 'Initials': 'G', 'LastName': 'Berkiten', 'Affiliation': 'Okmeydanı Training and Research Hospital, Department of\xa0Otorhinolaryngology-Head and Neck Surgery, Istambul, Turquia.'}, {'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Uyar', 'Affiliation': 'Okmeydanı Training and Research Hospital, Department of\xa0Otorhinolaryngology-Head and Neck Surgery, Istambul, Turquia.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2019.12.005']
772,30726969,Acipimox Acutely Increases GLP-1 Concentrations in Overweight Subjects and Hypopituitary Patients.,"CONTEXT


Glucagon-like peptide-1 (GLP-1) is an incretin hormone used therapeutically in type 2 diabetes and obesity. The interplay between ambient free fatty acids (FFAs) and GLP-1 remains unclear. Acipimox suppresses adipose tissue lipolysis via activation of the PUMA-G (also known as HCA2 and GPR109a) receptor.
OBJECTIVE


To investigate whether lowering of serum FFA level with acipimox affects GLP-1 secretion.
DESIGN


Two randomized crossover studies were performed in human subjects. Rat intestine was perfused intra-arterially and intraluminally, and l-cells were incubated with acipimox.
PARTICIPANTS


The participants were healthy overweight subjects and hypopituitary adult patients.
INTERVENTIONS


The overweight participants received acipimox 250 mg 60 minutes before an oral glucose test. The hypopituitary patients received acipimox 250 mg 12, 9, and 2 hours before and during the metabolic study day, when they were studied in the basal state and during a hyperinsulinemic euglycemic clamp.
RESULTS


Acipimox suppressed FFA but did not affect insulin in the clinical trials. In overweight subjects, the GLP-1 increase after the oral glucose tolerance test (area under the curve) was more than doubled [4119 ± 607 pmol/L × min (Acipimox) vs 1973 ± 375 pmol/L × min (control), P = 0.004]. In hypopituitary patients, acipimox improved insulin sensitivity (4.7 ± 0.8 mg glucose/kg/min (Acipimox) vs 3.1 ± 0.5 mg glucose/kg/min (control), P = 0.005], and GLP-1 concentrations increased ~40%. An inverse correlation between FFA and GLP-1 concentrations existed in both trials. In rat intestine, acipimox did not affect GLP-1 secretion, and l-cells did not consistently express the putative receptor for acipimox.
CONCLUSIONS


Acipimox treatment increases systemic GLP-1 levels in both obese subjects and hypopituitary patients. Our in vitro data indicate that the underlying mechanisms are indirect.",2019,"Acipimox suppresses adipose tissue lipolysis via activation of the PUMA-G (also known as HCA2 and GPR109a) receptor.
","['Overweight Subjects and Hypopituitary Patients', 'participants were healthy overweight subjects and hypopituitary adult patients', 'obese subjects and hypopituitary patients', 'human subjects']","['acipimox 250 mg 60 minutes before an oral glucose test', 'acipimox', 'Acipimox']","['insulin sensitivity', 'FFA', 'GLP-1 secretion, and l-cells', 'GLP-1 Concentrations', 'GLP-1 concentrations', 'FFA and GLP-1 concentrations', 'systemic GLP-1 levels']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C1126722', 'cui_str': 'acipimox 250 MG'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0050558', 'cui_str': 'acipimox'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0524977', 'cui_str': 'Intestinal L Cells'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0233615,"Acipimox suppresses adipose tissue lipolysis via activation of the PUMA-G (also known as HCA2 and GPR109a) receptor.
","[{'ForeName': 'Esben Thyssen', 'Initials': 'ET', 'LastName': 'Vestergaard', 'Affiliation': 'Medical Research Laboratories Aarhus University, Aarhus N, Denmark.'}, {'ForeName': 'Astrid Johanneson', 'Initials': 'AJ', 'LastName': 'Hjelholt', 'Affiliation': 'Medical Research Laboratories Aarhus University, Aarhus N, Denmark.'}, {'ForeName': 'Rune E', 'Initials': 'RE', 'LastName': 'Kuhre', 'Affiliation': 'Department of Biomedical Sciences and NNF Centre for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Møller', 'Affiliation': 'Medical Research Laboratories Aarhus University, Aarhus N, Denmark.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Larraufie', 'Affiliation': ""Metabolic Research Laboratories and Medical Research Council Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, Addenbrooke's Hospital, University of Cambridge, United Kingdom.""}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Gribble', 'Affiliation': ""Metabolic Research Laboratories and Medical Research Council Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, Addenbrooke's Hospital, University of Cambridge, United Kingdom.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Reimann', 'Affiliation': ""Metabolic Research Laboratories and Medical Research Council Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, Addenbrooke's Hospital, University of Cambridge, United Kingdom.""}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Jessen', 'Affiliation': 'Medical Research Laboratories Aarhus University, Aarhus N, Denmark.'}, {'ForeName': 'Jens Juul', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences and NNF Centre for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens Otto Lunde', 'Initials': 'JOL', 'LastName': 'Jørgensen', 'Affiliation': 'Medical Research Laboratories Aarhus University, Aarhus N, Denmark.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2018-02503']
773,32180219,The combination of ibrutinib and rituximab demonstrates activity in first-line follicular lymphoma.,"This phase 2 study evaluated the activity and safety of ibrutinib, a Bruton's tyrosine kinase inhibitor, plus rituximab in adults with previously untreated follicular lymphoma. Patients received once-daily ibrutinib 560 mg continuously plus once-weekly rituximab 375 mg/m 2  for 4 weeks beginning Week 1 (Arm 1, n = 60) or Week 9 (following an 8-week ibrutinib lead-in) to explore biomarkers (Arm 2, n = 20). The primary endpoint was the best overall response rate (ORR). The median age was 58 years; most had an Eastern Cooperative Oncology Group Performance Status of 0 (74%) and Stage III/IV disease (84%). At a median study follow-up of 34 months in Arm 1 and 29 months in Arm 2, ORRs were 85% [95% confidence interval (CI) 73-93] and 75% (95% CI 51-91), respectively, with complete responses in 40% and 50%. The median duration of response was not reached in either arm; 30-month progression-free and overall survival rates were 67% and 97% (Arm 1) and 65% and 100% (Arm 2). The most common adverse events were fatigue, diarrhoea and nausea. Higher grade (Grade 3/4) haematological, haemorrhagic and cardiac events occurred infrequently. Ibrutinib plus rituximab was active and tolerable in first-line follicular lymphoma.",2020,The median duration of response was not reached in either arm; 30-month progression-free and overall survival rates were 67% and 97% (Arm 1) and 65% and 100% (Arm 2).,"['adults with previously untreated follicular lymphoma', 'The median age was 58\xa0years; most had an Eastern Cooperative Oncology Group Performance Status of 0 (74%) and Stage III/IV disease (84', 'first-line follicular lymphoma']","['Ibrutinib plus rituximab', 'ibrutinib and rituximab']","['fatigue, diarrhoea and nausea', 'median duration of response', 'Higher grade (Grade 3/4) haematological, haemorrhagic and cardiac events', 'ORRs', 'overall survival rates', 'overall response rate (ORR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.118287,The median duration of response was not reached in either arm; 30-month progression-free and overall survival rates were 67% and 97% (Arm 1) and 65% and 100% (Arm 2).,"[{'ForeName': 'Nathan H', 'Initials': 'NH', 'LastName': 'Fowler', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Nastoupil', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'De Vos', 'Affiliation': 'David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Knapp', 'Affiliation': 'Zangmeister Cancer Center, Columbus, OH, USA.'}, {'ForeName': 'Ian W', 'Initials': 'IW', 'LastName': 'Flinn', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, TN, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Ranjana H', 'Initials': 'RH', 'LastName': 'Advani', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Sumeet', 'Initials': 'S', 'LastName': 'Bhatia', 'Affiliation': 'Community Health Network, Indianapolis, IN, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Mena', 'Affiliation': 'Providence St. Joseph Medical Center, Burbank, CA, USA.'}, {'ForeName': 'Richard Eric', 'Initials': 'RE', 'LastName': 'Davis', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sattva S', 'Initials': 'SS', 'LastName': 'Neelapu', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Eckert', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Ping', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Melannie', 'Initials': 'M', 'LastName': 'Co', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Darrin M', 'Initials': 'DM', 'LastName': 'Beaupre', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Jutta K', 'Initials': 'JK', 'LastName': 'Neuenburg', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'M Lia', 'Initials': 'ML', 'LastName': 'Palomba', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",British journal of haematology,['10.1111/bjh.16424']
774,32402650,"Task experience eliminates catecholaminergic effects on inhibitory control - A randomized, double-blind cross-over neurophysiological study.","Catecholaminergic neural transmission plays an important role during the inhibition of prepotent responses. Methylphenidate (MPH) is an important drug that modulates the catecholaminergic system. However, theoretical considerations suggest that the effects of drugs (e.g. MPH) on cognitive control may depend on prior learning effects. Here we investigate this in a conflict-modulated Go/Nogo task and evaluate neurophysiological processes associated with this dynamic using EEG signal decomposition methods and source localization analysis. The behavioral data show that prior learning experiences eliminate effects of MPH on response inhibition processes. On a neurophysiological level, we show that MPH modulates specific processes in medial frontal brain regions. Although MPH seems to consistently modulate neurophysiological processes associated with response inhibition, this is no longer sufficient to modulate behavioral performance once learning or task familiarization processes have taken place. An important consequence of this study finding is that it may be important to adjust MPH dosage depending on learning effects in a specific setting to constantly increase cognitive control functions in that setting. This has important implications for clinical practice, since MPH is the first-line pharmacological therapy in attention-deficit hyperactivity disorder (ADHD). Cross-over study designs with constant doses of MPH can mask effects on cognitive functions. The impact of learning needs careful consideration in cross-over study designs examining catecholaminergic drug effects.",2020,"Although MPH seems to consistently modulate neurophysiological processes associated with response inhibition, this is no longer sufficient to modulate behavioral performance once learning or task familiarization processes have taken place.",[],['Methylphenidate (MPH'],"['cognitive control functions', 'cognitive functions', 'catecholaminergic effects']",[],"[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0560393,"Although MPH seems to consistently modulate neurophysiological processes associated with response inhibition, this is no longer sufficient to modulate behavioral performance once learning or task familiarization processes have taken place.","[{'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Mückschel', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine of the TU Dresden, Schubertstraße 42, D-01309 Dresden, Germany.'}, {'ForeName': 'Veit', 'Initials': 'V', 'LastName': 'Roessner', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine of the TU Dresden, Schubertstraße 42, D-01309 Dresden, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Beste', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine of the TU Dresden, Schubertstraße 42, D-01309 Dresden, Germany. Electronic address: christian.beste@uniklinikum-dresden.de.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2020.03.013']
775,32402681,A Randomized Phase II Study of Perioperative Chemotherapy Plus Bevacizumab Versus Postoperative Chemotherapy Plus Bevacizumab in Patients With Upfront Resectable Hepatic Colorectal Metastases.,"INTRODUCTION


Whether patients with resectable colorectal liver metastases (CRLM) gain a survival benefit from perioperative chemotherapy remains controversial. The benefit of including bevacizumab in chemotherapy also remains unclear.
MATERIAL AND METHODS


Seventy-six patients with CRLM were randomly assigned to either 6 cycles of FOLFOX (folinic acid, 5-fluorouracil, and oxaliplatin)/FOLFIRI (folinic acid, 5-fluorouracil, and irinotecan) with bevacizumab before and after surgery or 12 cycles after surgery. Progression-free survival (PFS) was estimated using the Kaplan-Meier method and compared by the log-rank test.
RESULTS


The median PFS of all patients was 37.4 months at 5.4 years follow-up, and the median overall survival (OS) was not reached. The PFS between the perioperative group and the postoperative group did not reveal a statistical difference (P = .280). The OS was significantly better in the perioperative group (hazard ratio [HR], 0.60; 95% confidence interval [CI],) 0.35-1.02; P = .049). In subgroup patients with carcinoembryonic antigens (CEA) ≥ 5 ng/mL or those with over 2 liver metastases, perioperative group had longer OS than postoperative group (CEA: HR, 0.49; 95% CI, 0.25-0.93; P = .030; number of liver metastases: HR, 0.55; 95% CI, 0.30-0.99; P = .049). The largest liver metastases size, disease-free interval, and sidedness did not affect PFS or OS. There was no difference between the 2 groups in postoperative complications with bevacizumab or adverse events during chemotherapy.
CONCLUSIONS


In patients with resectable CRLMs, perioperative chemotherapy had no effect on PFS, but improved OS. Patients with high CEA levels or over 2 liver metastases may benefit from perioperative chemotherapy.",2020,"The OS was significantly better in the perioperative group (hazard ratio [HR], 0.60; 95% confidence interval [CI],) 0.35-1.02; P = .049).","['Seventy-six patients with CRLM', 'patients with resectable colorectal liver metastases (CRLM', 'Patients', 'Patients with high CEA levels or over 2 liver metastases']","['Perioperative Chemotherapy Plus Bevacizumab Versus Postoperative Chemotherapy Plus Bevacizumab', 'bevacizumab', 'FOLFOX (folinic acid, 5-fluorouracil, and oxaliplatin)/FOLFIRI (folinic acid, 5-fluorouracil, and irinotecan) with bevacizumab']","['Progression-free survival (PFS', 'PFS, but improved OS', 'median overall survival (OS', 'postoperative complications', 'adverse events', 'median PFS']","[{'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007082', 'cui_str': 'Carcinoembryonic antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",76.0,0.16738,"The OS was significantly better in the perioperative group (hazard ratio [HR], 0.60; 95% confidence interval [CI],) 0.35-1.02; P = .049).","[{'ForeName': 'You Jin', 'Initials': 'YJ', 'LastName': 'Chun', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Seong-Geun', 'Initials': 'SG', 'LastName': 'Kim', 'Affiliation': 'Division of Hemato-Oncology, On Hospital, Cancer Center, Busan, South Korea.'}, {'ForeName': 'Keun-Wook', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Sang Hee', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': 'Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, Hwasun, South Korea.'}, {'ForeName': 'Tae Won', 'Initials': 'TW', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ji Yeon', 'Initials': 'JY', 'LastName': 'Baek', 'Affiliation': 'Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Young Suk', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Soojung', 'Initials': 'S', 'LastName': 'Hong', 'Affiliation': 'Division of Oncology-Hematology, Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, South Korea.'}, {'ForeName': 'Chong Woo', 'Initials': 'CW', 'LastName': 'Chu', 'Affiliation': 'Divison of Hepato-biliary Surgery, Vinmec International Hospital, Hanoi, Vietnam.'}, {'ForeName': 'Seung-Hoon', 'Initials': 'SH', 'LastName': 'Beom', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Minkyu', 'Initials': 'M', 'LastName': 'Jung', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sang Joon', 'Initials': 'SJ', 'LastName': 'Shin', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Joong Bae', 'Initials': 'JB', 'LastName': 'Ahn', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea. Electronic address: vvswm513@yuhs.ac.'}]",Clinical colorectal cancer,['10.1016/j.clcc.2020.03.004']
776,32167864,Prognostic Value of Tumor Deposits for Disease-Free Survival in Patients With Stage III Colon Cancer: A Post Hoc Analysis of the IDEA France Phase III Trial (PRODIGE-GERCOR).,"PATIENTS AND METHODS


A post hoc analysis of all pathologic reports from patients with stage III CC included in the IDEA France phase III study (ClinicalTrials.gov identifier: NCT00958737) investigating the duration of adjuvant fluorouracil, leucovorin, and oxaliplatin or capecitabine and oxaliplatin therapy (3  v  6 months) was performed. The primary objective was to determine the prognostic impact of TD on disease-free survival (DFS). The effect of the addition of TD to LNM count on pN restaging was also evaluated. A multivariable analysis was performed to establish the association between TD and DFS.
RESULTS


Of 1,942 patients, 184 (9.5%) had TDs. The pN1a/b and pN1c populations showed similar DFS. TD-positive patients had worse prognosis compared with TD-negative patients, with 3-year DFS rates of 65.6% (95% CI, 58.0% to 72.1%) and 74.7% (95% CI, 72.6% to 76.7%;  P  = .0079), respectively. On multivariable analysis, TDs were associated with a higher risk of recurrence or death (hazard ratio [HR], 1.36;  P  = .0201). Other adverse factors included pT4 and/or pN2 disease (HR, 2.21;  P  < .001), the 3 months of adjuvant treatment (HR, 1.29;  P  = .0029), tumor obstruction (HR, 1.28;  P  = .0233), and male sex (HR, 1.24;  P  = .0151). Patients restaged as having pN2 disease (n = 35, 2.3%) had similar DFS as patients initially classified as pN2.
CONCLUSION


The presence of TDs is an independent prognostic factor for DFS in patients with stage III CC. The addition of TD to LNM may help to better define the duration of adjuvant therapy.",2020,"Other adverse factors included pT4 and/or pN2 disease (HR, 2.21;  P  < .001), the 3 months of adjuvant treatment (HR, 1.29;  P  = .0029), tumor obstruction (HR, 1.28;  P  = .0233), and male sex (HR, 1.24;  P  = .0151).","['patients with stage III CC', 'Of 1,942 patients, 184 (9.5%) had TDs', 'A post hoc analysis of all pathologic reports from patients with stage III CC included in the IDEA France phase III study (ClinicalTrials.gov identifier', 'Patients With Stage III Colon Cancer']","['fluorouracil, leucovorin, and oxaliplatin or capecitabine and oxaliplatin therapy']","['3-year DFS rates', 'higher risk of recurrence or death', 'tumor obstruction', 'prognostic impact of TD on disease-free survival (DFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4087140', 'cui_str': 'Tumour obstruction'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",,0.122603,"Other adverse factors included pT4 and/or pN2 disease (HR, 2.21;  P  < .001), the 3 months of adjuvant treatment (HR, 1.29;  P  = .0029), tumor obstruction (HR, 1.28;  P  = .0233), and male sex (HR, 1.24;  P  = .0151).","[{'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Delattre', 'Affiliation': 'Department of Medical Oncology, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Saint-Antoine, Paris, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Cohen', 'Affiliation': 'Department of Medical Oncology, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Saint-Antoine, Paris, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Henriques', 'Affiliation': 'Methodology and Quality of Life Unit in Oncology, University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Falcoz', 'Affiliation': 'Methodology and Quality of Life Unit in Oncology, University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Emile', 'Affiliation': 'Department of Pathology, AP-HP, Hôpital Ambroise Paré, Boulogne, France.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Fratte', 'Affiliation': 'Department of Medical Oncology, Hôpital de Belfort-Montbeliard, Montbeliard, France.'}, {'ForeName': 'Benoist', 'Initials': 'B', 'LastName': 'Chibaudel', 'Affiliation': 'Department of Medical Oncology, Institut Franco-Britannique, Levallois-Perret, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Dauba', 'Affiliation': 'Department of Medical Oncology, Centre Hospitalier Layné, Mont-de-Marsan, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Dupuis', 'Affiliation': 'Clinique Victor Hugo, Le Mans, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Bécouarn', 'Affiliation': 'Department of Medical Oncology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Bibeau', 'Affiliation': 'Department of Pathology, Centre Hospitalier Universitaire de Caen, Université Caen Normandie, Caen, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Taieb', 'Affiliation': 'Department of Medical Oncology, Sorbonne Paris Cité, Université Paris Descartes, AP-HP, Hôpital Européen Georges Pompidou, Paris, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Louvet', 'Affiliation': 'Department of Medical Oncology, Institut Mutualiste Montsouris, Paris, France.'}, {'ForeName': 'Dewi', 'Initials': 'D', 'LastName': 'Vernerey', 'Affiliation': 'Methodology and Quality of Life Unit in Oncology, University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'André', 'Affiliation': 'Department of Medical Oncology, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Saint-Antoine, Paris, France.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Svrcek', 'Affiliation': 'Sorbonne Université, Paris, France.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01960']
777,32402684,A randomized controlled trial comparing oral and intravenous iron supplementation after Roux-en-Y gastric bypass surgery.,"BACKGROUND


Iron deficiency (ID) is one of the most common postoperative deficiencies that may develop after Roux-en-Y gastric bypass (RYGB). The optimal mode of treatment is uncertain.
AIM


To compare the efficacy of oral ferrous fumarate (FF), oral ferrous gluconate (FG), and a single intravenous infusion of ferric carboxymaltose (FCM) in women with ID after RYGB.
METHODS


Multicenter randomized controlled trial including 120 women with a serum ferritin <20 μg/l during follow-up after RYGB. They were randomized into three groups: 41 patients were treated with FF 200 mg three times a day (total daily dose: 195 mg elemental iron), 39 received FG 695 mg twice a day (total daily dose: 160 mg elemental iron) for three months, and 39 patients were treated with a single intravenous dose of FCM (1000 mg elemental iron). Serum ferritin levels were measured at six weeks, and three, six and twelve months after the start of supplementation.
RESULTS


At three months, persistence of ID was observed in 29.4% and 42.4% of the patients treated with FF and FG, respectively, but in none of those treated with FCM (p < 0.001). Over the next nine months, recurrence of ID was observed in 56.5% of patients treated with FF, in 52.9% treated with FG, and in 27.8% of those treated with FCM. Adverse effects were most common during oral treatment.
CONCLUSION


In women developing ID after RYGB, a single dose of intravenous FCM is more effective and better tolerated than the standard treatment with either FF or FG.
CLINICAL TRIAL REGISTRY NUMBER AND WEBSITE


The study was registered at clinicaltrials.gov under number NCT02271997.",2020,"Over the next nine months, recurrence of ID was observed in 56.5% of patients treated with FF, in 52.9% treated with FG, and in 27.8% of those treated with FCM.","['120 women with a serum ferritin <20\xa0μg/l during follow-up after RYGB', 'women with ID after RYGB']","['FG 695\xa0mg twice a day (total daily dose', 'intravenous iron supplementation after Roux-en-Y gastric bypass surgery', 'oral ferrous fumarate (FF), oral ferrous gluconate (FG', 'ferric carboxymaltose (FCM', 'FF 200\xa0mg three times a day (total daily dose', 'FCM']","['persistence of ID', 'recurrence of ID', 'Adverse effects', 'effective and better tolerated', 'Serum ferritin levels']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}]","[{'cui': 'C0060277', 'cui_str': 'ferrous gluconate'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0060276', 'cui_str': 'Ferrous fumarate'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}, {'cui': 'C1102976', 'cui_str': 'Ferrous fumarate 200 MG'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}]","[{'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}]",120.0,0.302751,"Over the next nine months, recurrence of ID was observed in 56.5% of patients treated with FF, in 52.9% treated with FG, and in 27.8% of those treated with FCM.","[{'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Schijns', 'Affiliation': 'Department of Surgery, Rijnstate, Arnhem, the Netherlands. Electronic address: wendyschijns424@hotmail.com.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Boerboom', 'Affiliation': 'Department of Surgery, Rijnstate, Arnhem, the Netherlands.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'de Bruyn Kops', 'Affiliation': 'Department of Surgery, Rode Kruis Ziekenhuis, Beverwijk, the Netherlands.'}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'de Raaff', 'Affiliation': 'Department of Surgery, OLVG West, Amsterdam, the Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'van Wagensveld', 'Affiliation': 'Department of Surgery, OLVG West, Amsterdam, the Netherlands.'}, {'ForeName': 'Frits J', 'Initials': 'FJ', 'LastName': 'Berends', 'Affiliation': 'Department of Surgery, Rijnstate, Arnhem, the Netherlands.'}, {'ForeName': 'Ignace M C', 'Initials': 'IMC', 'LastName': 'Janssen', 'Affiliation': 'Department of Surgery, Rijnstate, Arnhem, the Netherlands.'}, {'ForeName': 'Cees J H M', 'Initials': 'CJHM', 'LastName': 'van Laarhoven', 'Affiliation': 'Department of Surgery, Radboud UMC, Nijmegen, the Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'de Boer', 'Affiliation': 'Department of Internal Medicine, Rijnstate, Arnhem, the Netherlands.'}, {'ForeName': 'Edo O', 'Initials': 'EO', 'LastName': 'Aarts', 'Affiliation': 'Department of Surgery, Rijnstate, Arnhem, the Netherlands.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.04.010']
778,32171499,[Comparison between erector spinal plane block and epidural block techniques for postoperative analgesia in open cholecystectomies: a randomized clinical trial].,"INTRODUCTION AND OBJECTIVES


Blockade of the Erector Spinal Muscle (ESP block) is a relatively new block, initially described for chronic thoracic pain analgesia, but it has already been described for anesthesia and analgesia in thoracic surgical procedures and, more recently, for high abdominal surgeries. The aim of the study was to compare two techniques, ESP Block and Epidural block with morphine and local anesthetic for postoperative analgesia of open cholecystectomy surgeries.
METHODS


Controlled single-blind randomized clinical trial with 31 patients (ESP block, n = 15; Epidural, n = 16), of both genders, ages between 27 and 77 years. The ESP block was performed at the T8 level with injection of 20 mL of 0.5% ropivacaine bilaterally. The epidural block was performed at the T8-T9 space with 20 mL of 0.5% ropivacaine and 1 mg of morphine.
RESULTS


The ESP block group presented higher mean Numeric Pain Scale (NPS) values for pain in the up to 2 hour (p = 0.001) and in the 24 hour (p = 0.001) assessments. The ESP block group had a three-fold increased risk (43.7% vs. 13.3%) of rescue opioid use in the 24 postoperative hours when compared to the epidural group (RR = 3.72, 95% CI: 0.91 to 15.31, p = 0.046).
CONCLUSION


ESP block did not prove to be an effective technique for postoperative analgesia of open cholecystectomy, at the doses performed in this study, having required more use of rescue opioid, and without differences in NPS. More comprehensive studies are required to assess the efficacy of ESP block for the visceral and abdominal somatic component, considering the specific blockade level.",2020,"CONCLUSION


ESP block did not prove to be an effective technique for postoperative analgesia of open cholecystectomy, at the doses performed in this study, having required more use of rescue opioid, and without differences in NPS.","['31 patients (ESP block, n = 15; Epidural, n = 16), of both genders, ages between 27 and 77 years', 'open cholecystectomies']","['erector spinal plane block and epidural block techniques', 'morphine', 'T8-T9 space with 20 mL of 0.5% ropivacaine', 'ESP Block and Epidural block with morphine and local anesthetic', 'ropivacaine']",['mean Numeric Pain Scale (NPS) values for pain'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015373', 'cui_str': 'Extrasensory Perception'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}]","[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0015373', 'cui_str': 'Extrasensory Perception'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",31.0,0.0862974,"CONCLUSION


ESP block did not prove to be an effective technique for postoperative analgesia of open cholecystectomy, at the doses performed in this study, having required more use of rescue opioid, and without differences in NPS.","[{'ForeName': 'Thiago Mamoru', 'Initials': 'TM', 'LastName': 'Sakae', 'Affiliation': 'Serviço de Anestesiologia SIANEST, Florianópolis, SC, Brasil; Universidade do Sul de Santa Catarina (UNISUL), Florianópolis, SC, Brazil. Electronic address: thiagosakae@gmail.com.'}, {'ForeName': 'Luiz Henrique Ide', 'Initials': 'LHI', 'LastName': 'Yamauchi', 'Affiliation': 'Serviço de Anestesiologia SIANEST, Florianópolis, SC, Brasil; Hospital Florianópolis, Florianópolis, SC, Brasil; TSA Sociedade Brasileira de Anestesiologia (SBA), Rio de Janeiro, RJ, Brasil.'}, {'ForeName': 'Augusto Key Karazawa', 'Initials': 'AKK', 'LastName': 'Takaschima', 'Affiliation': 'Serviço de Anestesiologia SIANEST, Florianópolis, SC, Brasil; Hospital Florianópolis, Florianópolis, SC, Brasil; TSA Sociedade Brasileira de Anestesiologia (SBA), Rio de Janeiro, RJ, Brasil.'}, {'ForeName': 'Julio C', 'Initials': 'JC', 'LastName': 'Brandão', 'Affiliation': 'TSA Sociedade Brasileira de Anestesiologia (SBA), Rio de Janeiro, RJ, Brasil.'}, {'ForeName': 'Roberto Henrique', 'Initials': 'RH', 'LastName': 'Benedetti', 'Affiliation': 'Serviço de Anestesiologia SIANEST, Florianópolis, SC, Brasil; Universidade do Sul de Santa Catarina (UNISUL), Florianópolis, SC, Brazil; Hospital Florianópolis, Florianópolis, SC, Brasil; TSA Sociedade Brasileira de Anestesiologia (SBA), Rio de Janeiro, RJ, Brasil.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2019.12.009']
779,32174573,Evaluation of Scheimpflug imaging system as an added tool in improving the accuracy of reference marking (as compared to the slit lamp marking system) for toric intraocular lens implantation.,"Purpose


To assess the role of Scheimpflug imaging in improving the accuracy of reference marking for toric IOL implantation.
Methods


In this prospective, randomized, clinical trial all patients with cataract and pre-existing significant regular corneal astigmatism, who required implantation of a toric IOL were included in the study, and patients with any ocular pathology or abnormality were excluded. Patients were divided into two groups: For one group of patients, Group I (GI), reference marking was finalized using slit lamp only, and for the second group, Group II (GII), after slit lamp marking, the reference marks were checked using Goniometer of Scheimpflug imaging. The primary outcome was to determine the axis of toric intraocular lens (IOL) postoperatively (within 1 hour) and compare it with the desired axis of placement.
Results


We found a statistically significant difference in the two groups (P < 0.001) suggesting Group II (4 step technique) is better than Group I (3 step technique).
Conclusion


Scheimpflug imaging, an extra step preoperatively, is an effective measure to reduce errors in reference marking and thereby improving the refractive outcome of toric intraocular lens.",2020,"We found a statistically significant difference in the two groups (P < 0.001) suggesting Group II (4 step technique) is better than Group I (3 step technique).
","['patients with cataract and pre-existing significant regular corneal astigmatism, who required implantation of a toric IOL were included in the study, and patients with any ocular pathology or abnormality were excluded']",[],['axis of toric intraocular lens (IOL) postoperatively (within 1 hour) and compare it with the desired axis of placement'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0339682', 'cui_str': 'Corneal astigmatism'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]",[],"[{'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]",,0.030955,"We found a statistically significant difference in the two groups (P < 0.001) suggesting Group II (4 step technique) is better than Group I (3 step technique).
","[{'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Amber Eye Care and Micro Surgery Centre, Thane, Maharashtra, India.'}, {'ForeName': 'Akanksha', 'Initials': 'A', 'LastName': 'Batra', 'Affiliation': 'Amber Eye Care and Micro Surgery Centre, Thane, Maharashtra, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_1253_19']
780,32174580,Surgically induced astigmatism and refractive outcomes following phacotrabeculectomy.,"Purpose


To objectively evaluate surgically induced astigmatism (SIA) after phacotrabeculectomy using keratometry and topography and to compare the magnitude of SIA and the refractive outcomes of single-site and twin-site phacotrabeculectomies.
Methods


Forty prospective subjects were enrolled in the study and were randomized into single-site and twin-site cohorts. SIA was objectively assessed using keratometry and Orbscan before and at three months after surgery. For both cohorts, the changes in SIA were assessed using power vector analysis compared at the third month after surgery.
Results


Each cohort consisted of 20 eyes. The preoperative parameters and postoperative IOP were comparable and similar, respectively, in both the cohorts (P = 0.1). Majority of the patients in both the cohorts had preoperative against-the-rule (ATR) astigmatism. The median change in SIA at the three-month postoperative visit was similar in both the cohorts, with a small increase in ATR astigmatism. Although the SIA change measured by keratometry in the J0 component was similar in both the groups (P = 0.54), that of J45 was significantly different (P = 0.01). However, the median change in SIA was similar in both the groups for both the J0 (P = 0.52) and J45 components (P = 0.94) when measured by Orbscan. The SIA in both the groups measured with keratometry (P = 0.62) and topography (P = 0.52) were clinically and statistically similar. In both the groups, the refraction was similar at 1 month and 3 months.
Conclusion


The SIA as measured with keratometry and topography was similar in the single-site and twin-site phacotrabeculectomy cohorts at the end of 3-months. The postoperative refraction was stabilized in 1-month in both the groups.",2020,The SIA in both the groups measured with keratometry (P = 0.62) and topography (P = 0.52) were clinically and statistically similar.,['Methods\n\n\nForty prospective subjects were enrolled in the study and were randomized into single-site and twin-site cohorts'],['phacotrabeculectomy'],"['SIA change measured by keratometry in the J0 component', 'preoperative parameters and postoperative IOP', 'median change in SIA', 'postoperative refraction', 'ATR astigmatism']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}]","[{'cui': 'C1167708', 'cui_str': 'Phacotrabeculectomy'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0430885', 'cui_str': 'Keratometry (procedure)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0430943', 'cui_str': 'Refraction'}, {'cui': 'C1720245', 'cui_str': 'Against-the-rule astigmatism'}]",40.0,0.0466958,The SIA in both the groups measured with keratometry (P = 0.62) and topography (P = 0.52) were clinically and statistically similar.,"[{'ForeName': 'Sirisha', 'Initials': 'S', 'LastName': 'Senthil', 'Affiliation': 'VST Glaucoma Center, L V Prasad Eye Institute, Banjara Hills, Hyderabad, Telangana, India.'}, {'ForeName': 'Sanket', 'Initials': 'S', 'LastName': 'Deshmukh', 'Affiliation': 'GMRV Campus, L V Prasad Eye Institute, Visakhapatnam, Andhra Pradesh, India.'}, {'ForeName': 'Kiranmaye', 'Initials': 'K', 'LastName': 'Turaga', 'Affiliation': 'GMRV Campus, L V Prasad Eye Institute, Visakhapatnam, Andhra Pradesh, India.'}, {'ForeName': 'Veerendranath', 'Initials': 'V', 'LastName': 'Pesala', 'Affiliation': 'Brien Holden Institute of Optometry and Vision Sciences, L V Prasad Eye Institute, Banjara Hills, Hyderabad, Telangana, India.'}, {'ForeName': 'Praveen K', 'Initials': 'PK', 'LastName': 'Bandela', 'Affiliation': 'Brien Holden Institute of Optometry and Vision Sciences, L V Prasad Eye Institute, Banjara Hills, Hyderabad, Telangana, India.'}, {'ForeName': 'Jonnadula', 'Initials': 'J', 'LastName': 'Ganesh', 'Affiliation': 'VST Glaucoma Center, L V Prasad Eye Institute, Banjara Hills, Hyderabad, Telangana, India.'}, {'ForeName': 'Chandrasekhar', 'Initials': 'C', 'LastName': 'Garudadri', 'Affiliation': 'VST Glaucoma Center, L V Prasad Eye Institute, Banjara Hills, Hyderabad, Telangana, India.'}, {'ForeName': 'Shrikant', 'Initials': 'S', 'LastName': 'Bharadwaj', 'Affiliation': 'VST Glaucoma Center, L V Prasad Eye Institute, Banjara Hills, Hyderabad, Telangana, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_588_19']
781,32174581,Intraoperative injection versus sponge-applied mitomycin C during trabeculectomy: One-year study.,"Purpose


To determine the safety and efficacy of mitomycin C (MMC) injection versus sponge during trabeculectomy.
Methods


It is a prospective analysis of patients who underwent trabeculectomy with MMC and followed up for 1 year, divided into two groups, namely, group 1- injection (n = 21), group 2-> sponge (n = 21). The same concentration of MMC was used for both groups. Inclusion criteria were trabeculectomies with MMC for intraocular pressure (IOP) control in eyes with glaucoma (primary + secondary) with a follow-up of 1 year.
Results


Mean preoperative IOP in group 1 was 29.00 ± 11.92 mmHg and group 2 was 25.87 ± 11.09 mmHg, which reduced to 12.19 ± 4.03 and 15.56 ± 10.72 mmHg at final visit with P value of 0.0002 and 0.001, respectively. Mean preoperative number of antiglaucoma medications was 2.4 ± 0.87 in group 1 and 2.3 ± 0.96 in group 2, which reduced to 0.38 ± 0.5 and 0.91 ± 0.85 with P value of 0.001 and 0.0003, respectively. The complete success rate was 52.4% in the injection group and 26.1% in the sponge group at end of 1 year. Overall, success rate (complete + qualified) was 90.5% and 87% in group 1 and group 2 at final visit. All major complications were encountered in sponge group. 1 (11.1%) patient developed choroidal detachment and one had malignant glaucoma which got resolved by medical management. 33.3% cases had encapsulated bleb which received bleb needling. 44.4% cases underwent Argon laser suture lysis postoperatively.
Conclusion


The MMC injection may be as safe and as effective as conventional sponge application with comparable estimated complete treatment success.",2020,"Overall, success rate (complete + qualified) was 90.5% and 87% in group 1 and group 2 at final visit.","['Inclusion criteria were trabeculectomies with MMC for intraocular pressure (IOP) control in eyes with glaucoma (primary + secondary) with a follow-up of 1 year', 'patients who underwent']","['mitomycin C (MMC) injection', 'Argon laser suture lysis postoperatively', 'trabeculectomy with MMC', 'Intraoperative injection versus sponge-applied mitomycin C during trabeculectomy', 'bleb needling']","['choroidal detachment and one had malignant glaucoma', 'Mean preoperative IOP', 'success rate', 'Mean preoperative number of antiglaucoma medications', 'complete success rate', 'safety and efficacy']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0392247', 'cui_str': 'Argon Ion Lasers'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0024348', 'cui_str': 'Lysis (morphologic abnormality)'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1705741', 'cui_str': 'Sponge (basic dose form)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C3714607', 'cui_str': 'Filtering bleb'}]","[{'cui': 'C0162279', 'cui_str': 'Choroidal detachment (disorder)'}, {'cui': 'C0271152', 'cui_str': 'Malignant glaucoma (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0609664,"Overall, success rate (complete + qualified) was 90.5% and 87% in group 1 and group 2 at final visit.","[{'ForeName': 'Devendra', 'Initials': 'D', 'LastName': 'Maheshwari', 'Affiliation': 'Department of Glaucoma, Aravind Eye Hospital and Post Graduate Institute of Ophthalmology, Tirunelveli, Tamil Nadu, India.'}, {'ForeName': 'Swathi', 'Initials': 'S', 'LastName': 'Kanduri', 'Affiliation': 'Department of Glaucoma, Aravind Eye Hospital and Post Graduate Institute of Ophthalmology, Tirunelveli, Tamil Nadu, India.'}, {'ForeName': 'Ramakrishnan', 'Initials': 'R', 'LastName': 'Rengappa', 'Affiliation': 'Department of Glaucoma, Aravind Eye Hospital and Post Graduate Institute of Ophthalmology, Tirunelveli, Tamil Nadu, India.'}, {'ForeName': 'Mohideen Abdul', 'Initials': 'MA', 'LastName': 'Kadar', 'Affiliation': 'Department of Glaucoma, Aravind Eye Hospital and Post Graduate Institute of Ophthalmology, Tirunelveli, Tamil Nadu, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_963_19']
782,32173916,"Efficacy of guselkumab in a subpopulation with pustulotic arthro-osteitis through week 52: an exploratory analysis of a phase 3, randomized, double-blind, placebo-controlled study in Japanese patients with palmoplantar pustulosis.","BACKGROUND


Previous studies of guselkumab have demonstrated clinical benefits in patients with plaque-type psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and palmoplantar pustulosis (PPP).
OBJECTIVE


The aim of this exploratory analysis of a double-blind, multicenter, placebo-controlled, phase 3 study in Japanese patients with PPP was to evaluate the efficacy of guselkumab in the subset of patients with pustulotic arthro-osteitis (PAO).
METHODS


Patients were randomized to receive guselkumab 100 or 200 mg at weeks 0, 4, 12 and every 8 weeks, or placebo with cross-over to guselkumab 100 or 200 mg at week 16 (placebo group). Efficacy endpoints were changes from baseline in magnetic resonance imaging (MRI) score, EuroQOL-5 dimensions (EQ-5D) index score, EQ-5D pain/discomfort dimension score and C-reactive protein (CRP, mg/L) level in all PAO patients through week 52. Data from both guselkumab groups were combined and presented as results for a single overall guselkumab group.
RESULTS


Among 159 patients with PPP, 66 with PAO were randomized across treatment groups. For patients with MRI data for all regions assessed, the proportion of patients in the guselkumab group with PAO characterized as severe decreased from 23.8% (10/42) at baseline to 5.4% (2/42) at week 52. The mean (SD) change from baseline at week 52 in EQ-5D index score was 0.20 (0.17) among PPP patients with PAO and 0.15 (0.17) among those without PAO in the guselkumab group. Among all PAO patients, the proportions with an EQ-5D pain/discomfort dimension score of no or slight pain/discomfort in the guselkumab group increased from baseline to week 52 [33.3% (7/21) vs. 87.5% (35/40)]. The mean (SD) CRP levels decreased in all PAO patients in the guselkumab group at week 52 compared to baseline [-1.71 (8.16) mg/L].
CONCLUSION


Guselkumab treatment showed beneficial outcomes for PAO signs and symptoms in Japanese patients with PPP.",2020,"The mean (SD) CRP levels decreased in all PAO patients in the guselkumab group at week 52 compared to baseline (-1.71 [8.16] mg/L).
","['Japanese patients with PPP', '159 patients with PPP, 66 with PAO', 'Japanese patients with palmoplantar pustulosis', 'Patients', 'patients with plaque-type psoriasis, generalized pustular psoriasis, erythrodermic psoriasis, and palmoplantar pustulosis (PPP', 'patients with pustulotic arthro-osteitis (PAO']","['placebo', 'placebo with cross-over to guselkumab 100 mg or 200 mg at week 16 (placebo', 'guselkumab', 'Guselkumab treatment']","['PAO signs and symptoms', 'mean (SD) CRP levels', 'EQ-5D index score', 'magnetic resonance imaging (MRI) score, EuroQOL-5 dimensions (EQ-5D) index score, EQ-5D pain/discomfort dimension score, and C-reactive protein (CRP, mg/L) level', 'EQ-5D pain/discomfort dimension score of no or slight pain/discomfort']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0030246', 'cui_str': 'Pustulosis of Palms and Soles'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0343055', 'cui_str': 'Generalized pustular psoriasis (disorder)'}, {'cui': 'C0748052', 'cui_str': 'Exfoliative psoriasis'}, {'cui': 'C0029400', 'cui_str': 'Bone Inflammation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0010366', 'cui_str': 'Crossing Over, Genetic'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439268', 'cui_str': 'microgram/mL'}, {'cui': 'C2937276', 'cui_str': 'Slight (qualifier value)'}]",159.0,0.371991,"The mean (SD) CRP levels decreased in all PAO patients in the guselkumab group at week 52 compared to baseline (-1.71 [8.16] mg/L).
","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Dermatology, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Fukuda', 'Affiliation': 'Department of Radiology, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Morita', 'Affiliation': 'Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Janssen Pharmaceutical K.K, Tokyo, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Morishima', 'Affiliation': 'Janssen Pharmaceutical K.K, Tokyo, Japan.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Goto', 'Affiliation': 'Janssen Pharmaceutical K.K, Tokyo, Japan.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Zheng', 'Affiliation': 'Janssen Pharmaceutical K.K, Tokyo, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Terui', 'Affiliation': 'Department of Dermatology, Nihon University School of Medicine, Tokyo, Japan.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16355']
783,30298608,Benefit of Early versus Deferred Antiretroviral Therapy on Progression of Liver Fibrosis among People with HIV in the START Randomized Trial.,"The role of antiretroviral therapy (ART) in reducing or contributing to liver fibrosis in persons with human immunodeficiency virus (HIV) is unclear. We evaluated participants in the Strategic Timing of AntiRetroviral Treatment (START) trial for liver fibrosis using the AST to Platelet Ratio Index (APRI) and Fibrosis-4 Index (FIB-4), and assessed for a benefit of early versus delayed ART on liver fibrosis progression. ART-naïve persons with high CD4 counts (>500 cells/µL) from 222 clinical sites in 35 countries were randomized to receive ART either at study enrollment (immediate treatment arm) or when their CD4 count fell below 350 cells/µL (deferred treatment arm). The following outcomes were evaluated: fibrosis (APRI > 0.5 or FIB-4 > 1.45), significant fibrosis (APRI > 1.5 or FIB-4 > 3.25), hepatic flare, and resolution of elevated APRI and FIB-4 scores. Of the 4,684 enrolled into the START study, 104 did not have APRI or FIB-4 results and were excluded. Among 4,580 participants (2,273 immediate treatment; 2,307 deferred treatment), the median age was 36 years, 26.9% were female, and 30.4% were black. Three percent had an alcoholism or substance abuse history, 6.4% had hepatitis B and/or C, and 1.1% had significant fibrosis at baseline. The median CD4 count was 651, and 5.3% had HIV RNA ≤ 200. Immediate arm participants were at lower risk of developing increased fibrosis scores than deferred arm participants (hazard ratio [HR] = 0.66; 95% confidence interval [CI] = 0.57-0.78; P < 0.001) and more likely to have resolution of elevated baseline scores (HR 1.6; 95% CI 1.3-1.9; P < 0.001). Conclusions: Significant liver fibrosis was rare among ART-naïve HIV-positive persons with high CD4 counts. Our findings suggest a benefit of early ART in preventing the development of liver fibrosis.",2019,Immediate arm participants were at lower risk of developing increased fibrosis scores than deferred arm participants (hazard ratio [HR] = 0.66; 95% confidence interval [CI] = 0.57-0.78; P < 0.001) and more likely to have resolution of elevated baseline scores (HR 1.6; 95% CI 1.3-1.9; P < 0.001).,"['ART-naïve persons with high CD4 counts (>500 cells/µL) from 222 clinical sites in 35 countries', '4,580 participants (2,273 immediate treatment; 2,307 deferred treatment), the median age was 36 years, 26.9% were female, and 30.4% were black', 'People with HIV', 'persons with human immunodeficiency virus (HIV', '4,684 enrolled into the START study, 104 did not have APRI or FIB-4 results and were excluded']","['Early versus Deferred Antiretroviral Therapy', 'antiretroviral therapy (ART']","['hepatic flare, and resolution of elevated APRI and FIB-4 scores', 'Platelet Ratio Index (APRI) and Fibrosis-4 Index (FIB-4', 'alcoholism or substance abuse history', 'fibrosis scores', 'Significant liver fibrosis', 'median CD4 count', 'Progression of Liver Fibrosis']","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0910435', 'cui_str': 'AM 36'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4304377', 'cui_str': 'Fibrosis-4 index'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C0740858', 'cui_str': 'Substance Abuse'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",4684.0,0.154622,Immediate arm participants were at lower risk of developing increased fibrosis scores than deferred arm participants (hazard ratio [HR] = 0.66; 95% confidence interval [CI] = 0.57-0.78; P < 0.001) and more likely to have resolution of elevated baseline scores (HR 1.6; 95% CI 1.3-1.9; P < 0.001).,"[{'ForeName': 'Nila J', 'Initials': 'NJ', 'LastName': 'Dharan', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Neuhaus', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota, United States.'}, {'ForeName': 'Juergen K', 'Initials': 'JK', 'LastName': 'Rockstroh', 'Affiliation': 'University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Peters', 'Affiliation': 'CHIP, Department of Infectious Disease, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Gordin', 'Affiliation': 'VA Medical Center, Washington, DC.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Arenas-Pinto', 'Affiliation': 'MRC Clinical Trails Unit, University College London, London, United Kingdom.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Emerson', 'Affiliation': 'Belfast Healthcare Trust, Belfast, United Kingdom.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Marks', 'Affiliation': 'Weill Medical College of Cornell University, New York, NY.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Hidalgo', 'Affiliation': 'Vía Libre / Guillermo Almenara Hospital, Lima, Peru.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Sarmento-Castro', 'Affiliation': 'University Hospital of Porto, Porto, Portugal.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Stephan', 'Affiliation': 'Johann Wolfgang Goethe University Hospital, Frankfurt, Germany.'}, {'ForeName': 'Nagalingeswaran', 'Initials': 'N', 'LastName': 'Kumarasamy', 'Affiliation': 'YRGCARE Medical Centre, Voluntary Health Services, Chennai, India.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Emery', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Gail V', 'Initials': 'GV', 'LastName': 'Matthews', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30296']
784,32072695,"Orally administered mixed carotenoids protect human skin against ultraviolet A-induced skin pigmentation: A double-blind, placebo-controlled, randomized clinical trial.","BACKGROUND


Photoprotection of human skin is determined as the capacity of sunscreens to prevent ultraviolet (UV) B radiation-induced erythema and UVA radiation-induced pigmentation. It is unequivocal that, in addition to sunscreens, oral supplementation with carotenoids can protect human skin against UVB radiation-induced erythema. It is not known if this is also the case for UVA radiation-induced pigmentation.
OBJECTIVE


To clinically evaluate the photoprotective effects of daily supplementation with carotenoids against UVA radiation-induced pigmentation.
METHODS


In this double-blind, placebo-controlled trial, 60 subjects (Fitzpatrick types II-IV) were randomized to receive Nutrilite™ Multi Carotene supplement or placebo for 12 weeks. UVB-induced minimal erythemal dose (MED), UVA-induced minimal persistent pigmentation dose (MPPD) and skin carotenoid levels were measured at baseline, 4, 8, and 12 weeks of intervention. Skin color was evaluated by expert clinical graders and by colorimetry. Carotenoid levels in the skin were measured by the Biozoom ®  device.
RESULTS


In the intervention group, a significant increase in comparison with the placebo group was observed in (a) skin carotenoid levels, (b) UVB-induced MED, and (c) UVA-induced MPPD values obtained by colorimetry.
CONCLUSION


Daily supplementation with carotenoids protects human skin against both UVB-induced erythema and UVA-induced pigmentation.",2020,"In the intervention group, a significant increase in comparison with the placebo group was observed in (i) skin carotenoid levels, (ii) UVB-induced MED and (iii) UVA-induced MPPD values obtained by colorimetry.
","['60 subjects (Fitzpatrick types II-IV', 'induced skin pigmentation']","['carotenoids against UVA radiation-induced pigmentation', 'placebo', 'mixed carotenoids protect human skin against Ultraviolet A', 'UVB-induced Minimal Erythemal dose (MED', 'Nutrilite™ Multi Carotene supplement or placebo']","[' UVA-induced Minimal Persistent Pigmentation Dose (MPPD) and skin carotenoid levels', 'Carotenoid levels', 'i) skin carotenoid levels, (ii) UVB-induced MED and (iii) UVA-induced MPPD values', 'Skin color']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1269684', 'cui_str': 'Skin pigmented'}]","[{'cui': 'C0007271', 'cui_str': 'Carotenes and Carotenoids'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C1532472', 'cui_str': 'Ultraviolet'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0373568', 'cui_str': 'Carotene measurement (procedure)'}]","[{'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0007271', 'cui_str': 'Carotenes and Carotenoids'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0037290', 'cui_str': 'Skin Tone'}]",60.0,0.224159,"In the intervention group, a significant increase in comparison with the placebo group was observed in (i) skin carotenoid levels, (ii) UVB-induced MED and (iii) UVA-induced MPPD values obtained by colorimetry.
","[{'ForeName': 'Sudhir M', 'Initials': 'SM', 'LastName': 'Baswan', 'Affiliation': 'Global Discovery R&D, Amway Corporation, Ada, MI, USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Marini', 'Affiliation': 'IUF - Leibniz Research Institute for Environmental Medicine, Düsseldorf, Germany.'}, {'ForeName': 'Allison E', 'Initials': 'AE', 'LastName': 'Klosner', 'Affiliation': 'Nutrilite Health Institute R&D, Amway Corporation, Buena Park, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaenicke', 'Affiliation': 'IUF - Leibniz Research Institute for Environmental Medicine, Düsseldorf, Germany.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Leverett', 'Affiliation': 'Global Discovery R&D, Amway Corporation, Ada, MI, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Murray', 'Affiliation': 'Nutrilite Health Institute R&D, Amway Corporation, Buena Park, CA, USA.'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Gellenbeck', 'Affiliation': 'Nutrilite Health Institute R&D, Amway Corporation, Buena Park, CA, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Krutmann', 'Affiliation': 'IUF - Leibniz Research Institute for Environmental Medicine, Düsseldorf, Germany.'}]","Photodermatology, photoimmunology & photomedicine",['10.1111/phpp.12541']
785,32167664,First-line crizotinib versus platinum-pemetrexed chemotherapy in patients with advanced ROS1-rearranged non-small-cell lung cancer.,"OBJECTIVES


Food and Drug Administration (FDA) approved crizotinib for advanced ROS1-rearranged (ROS1+) non-small-cell lung cancer (NSCLC) patients due to a single-arm study PROFILE 1001. However, there is no direct comparison between crizotinib and platinum-pemetrexed chemotherapy.
MATERIALS AND METHODS


Clinical data of advanced ROS1+NSCLC patients treated with first-line crizotinib or platinum-pemetrexed chemotherapy between August 2010 and December 2017 were analyzed.
RESULTS


Seventy-seven patients were eligible, including 30 (39.0%) in the crizotinib group and 47 (61.0%) in the platinum-pemetrexed chemotherapy group. The median follow-up was 28.1 months (95% confidence interval [CI]: 19.2-39.0). The objective response rate (ORR) of crizotinib (86.7%, 95% CI: 73.3-96.7) was higher than that of platinum-pemetrexed chemotherapy (44.7%, 95% CI: 29.8-57.4, P < .001). The disease control rate (DCR) was 96.7% (95% CI: 90.0-100) in the crizotinib group and 85.1% (95% CI: 74.5-95.7) in the chemotherapy group (P = .140). Significantly longer progression-free survival (PFS) was observed in the patients treated with crizotinib (18.4 months, 95% CI: 6.4-30.3) versus platinum-pemetrexed chemotherapy (8.6 months, 95% CI: 6.9-10.3, P < .001). Overall survival (OS) was also compared between the two groups and no significant difference was seen (Not reach vs 28.4 months [95% CI: 20.7-36.0], P = .176). Notably, a total of 37 patients have treatment crossover after the failure of first-line treatment. Among those patients, difference in OS was not statistically significant between seven patients who have given first-line crizotinib (38.6 months, 95% CI: 0-81.0) and 30 patients who have given platinum-pemetrexed chemotherapy initially (32.8 months, 95% CI: 11.9-53.8, P = .805).
CONCLUSIONS


Our results suggested that first-line crizotinib had higher ORR and longer PFS than platinum-pemetrexed chemotherapy in patients with advanced ROS1+NSCLC, but the differences were not observed for OS.",2020,The disease control rate (DCR) was 96.7% (95% CI: 90.0-100) in the crizotinib group and 85.1% (95% CI: 74.5-95.7) in the chemotherapy group (P = .140).,"['Seventy-seven patients were eligible, including 30 (39.0%) in the crizotinib group and 47 (61.0%) in the platinum-pemetrexed chemotherapy group', 'Clinical data of advanced ROS1+NSCLC patients treated with first-line crizotinib or platinum-pemetrexed chemotherapy between August 2010 and December 2017 were analyzed', 'patients with advanced ROS1-rearranged non-small-cell lung cancer']","['First-line crizotinib versus platinum-pemetrexed chemotherapy', 'platinum-pemetrexed chemotherapy']","['progression-free survival (PFS', 'Overall survival (OS', 'objective response rate (ORR) of crizotinib', 'ORR and longer PFS', 'disease control rate (DCR', 'OS']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",77.0,0.125517,The disease control rate (DCR) was 96.7% (95% CI: 90.0-100) in the crizotinib group and 85.1% (95% CI: 74.5-95.7) in the chemotherapy group (P = .140).,"[{'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Qiang', 'Affiliation': 'Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Ziming', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Ding', 'Affiliation': 'Department of Oncology, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'Yongfeng', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}]",Cancer medicine,['10.1002/cam4.2972']
786,31618706,A randomised controlled trial of blood pressure self-monitoring in the management of hypertensive pregnancy. OPTIMUM-BP: A feasibility trial.,"OBJECTIVE


To assess the feasibility of a blood pressure self-monitoring intervention for managing pregnancy hypertension.
STUDY DESIGN


OPTIMUM-BP was an unmasked randomised controlled trial comparing a self-monitoring of blood pressure (SMBP) intervention versus usual care for the management of pregnancy hypertension. Women with chronic (CH) or gestational hypertension (GH) from 4 UK centres were randomised (2:1) intervention to control. Self-monitoring involved daily home blood pressure (BP) measurements, with recording via study diary or telemonitoring. Clinicians were invited to use the home readings in clinical and antihypertensive titration decisions.
MAIN OUTCOMES


The primary outcomes were recruitment, retention, adherence and persistence with the intervention.
RESULTS


Women from four UK centres were randomised: 158/222 (71%) of those approached agreed, comprising: 86 women with chronic hypertension (55 SMBP, 31 control) and 72 with gestational hypertension (49 SMBP, 23 control) of whom outcome data were available from 154 (97%) and were included in the analysis. The median (IQR) number of days with home BP readings per week were 5.5 (3.1-6.5) for those with chronic hypertension and 6.1 (4.5-6.7) with gestational hypertension. Participants persisted with the intervention for 80% or more of their time from enrolment until delivery in 86% (43/50) and 76% (38/49) of those with chronic and gestational hypertension respectively. Recorded clinic and study BPs were similar for both groups.
CONCLUSIONS


This is the first randomised investigation of BP self-monitoring for the management of pregnancy hypertension and indicates that a large RCT would be feasible.",2019,"Recorded clinic and study BPs were similar for both groups.
","['pregnancy hypertension', 'BP', 'hypertensive pregnancy', 'Women with chronic (CH) or gestational hypertension (GH) from 4 UK centres', 'Women from four UK centres were randomised: 158/222 (71%) of those approached agreed, comprising: 86 women with chronic hypertension (55 SMBP, 31 control) and 72 with gestational hypertension (49 SMBP, 23 control) of whom outcome data were available from 154 (97%) and were included in the analysis']","['self-monitoring of blood pressure (SMBP) intervention versus usual care', 'blood pressure self-monitoring intervention', 'blood pressure self-monitoring']","['median (IQR) number of days with home BP readings', 'recruitment, retention, adherence and persistence with the intervention', 'daily home blood pressure (BP) measurements']","[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0852036', 'cui_str': 'Hypertension, Pregnancy-Induced'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking (procedure)'}]",86.0,0.160276,"Recorded clinic and study BPs were similar for both groups.
","[{'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'Pealing', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GG, UK. Electronic address: louise.pealing@phc.ox.ac.uk.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Tucker', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GG, UK. Electronic address: katherine.tucker@phc.ox.ac.uk.'}, {'ForeName': 'Lucy H', 'Initials': 'LH', 'LastName': 'Mackillop', 'Affiliation': ""Women's Centre, Oxford University Hospitals NHS Foundation Trust, Level 6, John Radcliffe Hospital, Headley Way, Oxford OX3 9DU, UK. Electronic address: Lucy.mackillop@ouh.nhs.uk.""}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Crawford', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GG, UK. Electronic address: carole.crawford@phc.ox.ac.uk.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Wilson', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK. Electronic address: hannah.1.wilson@kcl.ac.uk.""}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Nickless', 'Affiliation': ""Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GG, UK; Atmospheric Chemistry Research Group, School of Chemistry, University of Bristol, Cantock's Close BS8 1TS, UK. Electronic address: alecia.nickless@bristol.ac.uk.""}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Temple', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GG, UK. Electronic address: Eleanor.temple@phc.ox.ac.uk.'}, {'ForeName': 'Lucy C', 'Initials': 'LC', 'LastName': 'Chappell', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK. Electronic address: lucy.chappell@kcl.ac.uk.""}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'McManus', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GG, UK. Electronic address: richard.mcmanus@phc.ox.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pregnancy hypertension,['10.1016/j.preghy.2019.09.018']
787,32162214,Cost-Effectiveness of IncobotulinumtoxinA in the Treatment of Sialorrhea in Patients with Various Neurological Conditions.,"INTRODUCTION


Sialorrhea is a common and debilitating symptom associated with neurological conditions, which can result in considerable physical and psychosocial complications. In Australia, management options are limited and further impeded by the lack of approved treatments. Whilst there is emerging evidence for the efficacy and tolerability of botulinum toxin (BoNT) for the treatment of sialorrhea in patients with neurological conditions, the cost-effectiveness of the treatment is yet to be established.
OBJECTIVES


To evaluate the cost-effectiveness of incobotulinumtoxinA for the treatment of chronic troublesome sialorrhea caused by various neurological conditions from the Australian healthcare perspective.
METHODS


A Markov state transition model was developed to perform a cost-utility analysis comparing incobotulinumtoxinA with standard of care (SoC). The model consisted of a hypothetical cohort of patients transiting between three severity-based health states, defined according to the Drooling Severity and Frequency Scale (DSFS), in 16-weekly cycles over 5 years. All clinical and utility inputs were sourced from a single placebo-controlled randomised clinical trial. Only direct healthcare costs were considered, and potential indirect costs such as carer's time and lost productivity were ignored. The primary outcome measure was the incremental cost per quality-adjusted life-year (QALY). Univariate and probabilistic sensitivity analyses were conducted.
RESULTS


The model demonstrated that proportionally more patients spent time in less severe sialorrhea health states in the incobotulinumtoxinA arm. For example, over the 5-year period, patients receiving incobotulinumtoxinA were estimated to spend 1.6 years with minimal or no sialorrhea, while no patients achieved this level of improvement under SoC. IncobotulinumtoxinA was shown to have an incremental cost per QALY gained of A$23,445 when compared with SoC.
CONCLUSIONS


The quality of life (QoL) of patients with sialorrhea caused by neurological conditions was considerably compromised. IncobotulinumtoxinA was shown to successfully alleviate sialorrhea and it was demonstrated to be a cost-effective intervention when compared with SoC alone.",2020,The model demonstrated that proportionally more patients spent time in less severe sialorrhea health states in the incobotulinumtoxinA arm.,"['patients with neurological conditions', 'Patients with Various Neurological Conditions']","['botulinum toxin (BoNT', 'incobotulinumtoxinA', 'IncobotulinumtoxinA', 'incobotulinumtoxinA with standard of care (SoC']","['severe sialorrhea health states', 'efficacy and tolerability', 'incremental cost per quality-adjusted life-year (QALY', 'quality of life (QoL', 'Drooling Severity and Frequency Scale (DSFS', 'neurological conditions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C2930113', 'cui_str': 'incobotulinumtoxinA'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0037036', 'cui_str': 'Hypersalivation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0034380'}, {'cui': 'C0013132', 'cui_str': 'Drooling'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",,0.0288848,The model demonstrated that proportionally more patients spent time in less severe sialorrhea health states in the incobotulinumtoxinA arm.,"[{'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Makino', 'Affiliation': 'THEMA Consulting Pty. Ltd., Sydney, Australia. kmakino@thema.net.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Mahant', 'Affiliation': 'Neurology, Westmead Hospital, Sydney, Australia.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Tilden', 'Affiliation': 'THEMA Consulting Pty. Ltd., Sydney, Australia.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Aghajanian', 'Affiliation': 'THEMA Consulting Pty. Ltd., Sydney, Australia.'}]",Neurology and therapy,['10.1007/s40120-020-00182-8']
788,32163578,Serum bicarbonate and cardiovascular events in hypertensive adults: results from the Systolic Blood Pressure Intervention Trial.,"BACKGROUND


Low serum bicarbonate level is associated with increased mortality, but its role as a predictor of cardiovascular disease (CVD) is unclear. This study evaluates the association between serum bicarbonate concentration and CVD and whether the effect of intensive blood pressure (BP) lowering on CVD outcomes is modified by serum bicarbonate level.
METHODS


The Systolic Blood Pressure Intervention Trial (SPRINT) randomized participants to a systolic BP target <120 mmHg (intensive treatment) or <140 mmHg (standard treatment). The primary CVD outcome was a composite of nonfatal myocardial infarction (MI), acute coronary syndrome not resulting in MI, stroke, acute decompensated heart failure and CVD death. Cox proportional hazards models adjusted for demographic, clinical and laboratory characteristics were used to evaluate the association of interest in 9334 SPRINT participants (ClinicalTrials.gov: NCT01206062).
RESULTS


Over a median follow-up of 3.33 years (interquartile range 2.87-3.87 years), 618 (6.6%) participants experienced a primary CVD outcome. Participants with serum bicarbonate <22 mEq/L had a significantly higher risk of the primary CVD outcome (hazard ratio 1.54; 95% confidence interval 1.11-2.14, P = 0.01), compared with participants with bicarbonate 22-26 mEq/L. The magnitude of the CVD risk reduction with intensive BP lowering was similar across bicarbonate strata (P-value for interaction = 0.97).
CONCLUSIONS


In hypertensive individuals, serum bicarbonate level <22 mEq/L was associated with an increased CVD risk. The effect of intensive BP lowering on CVD outcomes was not modified by the serum bicarbonate level.",2019,"Participants with serum bicarbonate <22 mEq/L had a significantly higher risk of the primary CVD outcome (hazard ratio 1.54; 95% confidence interval 1.11-2.14, P = 0.01), compared with participants with bicarbonate 22-26 mEq/L.","['participants to a systolic BP target <120\u2009mmHg (intensive treatment) or <140\u2009mmHg (standard treatment', 'hypertensive adults']","['intensive blood pressure (BP', 'intensive BP lowering']","['CVD outcomes', 'Serum bicarbonate and cardiovascular events', 'composite of nonfatal myocardial infarction (MI), acute coronary syndrome not resulting in MI, stroke, acute decompensated heart failure and CVD death', 'CVD risk', 'risk of the primary CVD outcome', 'serum bicarbonate level']","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]","[{'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]",9334.0,0.215464,"Participants with serum bicarbonate <22 mEq/L had a significantly higher risk of the primary CVD outcome (hazard ratio 1.54; 95% confidence interval 1.11-2.14, P = 0.01), compared with participants with bicarbonate 22-26 mEq/L.","[{'ForeName': 'Mirela', 'Initials': 'M', 'LastName': 'Dobre', 'Affiliation': 'Division of Nephrology and Hypertension, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Beddhu', 'Affiliation': 'Veterans Affairs Salt Lake City Healthcare System, University of Utah Health, Salt Lake City, UT, USA.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Renal Diseases and Hypertension, University of Colorado Denver Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Hostetter', 'Affiliation': 'Division of Nephrology and Hypertension, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'VA Medical Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Mahboob', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'Division of Nephrology and Hypertension, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Servilla', 'Affiliation': 'Nephrology, New Mexico VA Health Care System, Albuquerque, NM, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Weiner', 'Affiliation': 'Medicine, Nephrology, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Jackson T', 'Initials': 'JT', 'LastName': 'Wright', 'Affiliation': 'Division of Nephrology and Hypertension, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Kalani L', 'Initials': 'KL', 'LastName': 'Raphael', 'Affiliation': 'Veterans Affairs Salt Lake City Healthcare System, University of Utah Health, Salt Lake City, UT, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz149']
789,32091536,Association of Black Race With Early Recurrence After Minor Ischemic Stroke or Transient Ischemic Attack: Secondary Analysis of the POINT Randomized Clinical Trial.,"Importance


Stroke incidence is higher among black than white individuals in the United States. It is unclear whether black individuals have a higher risk of stroke recurrence after a minor ischemic stroke or transient ischemic attack (TIA), a high-risk setting in which focused preventive efforts can be effective.
Objective


To examine the association between black race and early ischemic stroke recurrence.
Design, Setting, and Participants


This cohort study analyzed data from the Platelet Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial conducted at 269 sites from May 28, 2010, to December 19, 2017. The trial enrolled 4881 adults within 12 hours of onset of a minor ischemic stroke (National Institutes of Health Stroke Scale score, 0-3) or high-risk TIA (ABCD2 score, ≥4). For this analysis, we excluded 598 patients enrolled outside the United States and 239 US patients with missing race/ethnicity data.
Main Outcomes and Measures


The primary outcome for this analysis was ischemic stroke within 90 days after randomization. Covariates included age, sex, Hispanic ethnicity, study assignment to take clopidogrel vs placebo, index stroke vs TIA, vascular risk factors, statin use, study drug adherence, and index event etiological subtype.
Results


Among 4044 patients included in the analysis, 918 (22.7%) were black. In an adjusted Cox model, black race was associated with a higher risk of recurrence compared with white race (hazard ratio, 1.6; 95% CI, 1.1-2.3). Findings were similar in subgroup analyses and in analyses limited to sites that enrolled black patients.
Conclusions and Relevance


Among US participants in the POINT trial, black individuals faced a higher risk of early stroke recurrence after a minor ischemic stroke or TIA. Our findings support research into black-white racial differences in the underlying mechanisms of recurrent stroke. In the meantime, extra effort should be made to ensure that black patients have access to proven secondary prevention measures.
Trial Registration


clinicaltrials.gov Identifier: NCT00991029.",2020,"In an adjusted Cox model, black race was associated with a higher risk of recurrence compared with white race (hazard ratio, 1.6; 95% CI, 1.1-2.3).","['4044 patients included in the analysis, 918 (22.7%) were black', '598 patients enrolled outside the United States and 239 US patients with missing race/ethnicity data', 'Participants\n\n\nThis cohort study analyzed data from the Platelet Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial conducted at 269 sites from May 28, 2010, to December 19, 2017', '4881 adults within 12 hours of onset of a minor ischemic stroke (National Institutes of Health Stroke Scale score, 0-3) or high-risk TIA (ABCD2 score, ≥4']",['clopidogrel vs placebo'],"['risk of early stroke recurrence', 'ischemic stroke', 'Black Race']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}]",4881.0,0.352948,"In an adjusted Cox model, black race was associated with a higher risk of recurrence compared with white race (hazard ratio, 1.6; 95% CI, 1.1-2.3).","[{'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Kamel', 'Affiliation': 'Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute and Department of Neurology, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Cenai', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute and Department of Neurology, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Dawn O', 'Initials': 'DO', 'LastName': 'Kleindorfer', 'Affiliation': 'Department of Neurology, University of Cincinnati, Ohio.'}, {'ForeName': 'Emily B', 'Initials': 'EB', 'LastName': 'Levitan', 'Affiliation': 'Department of Epidemiology, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Virginia J', 'Initials': 'VJ', 'LastName': 'Howard', 'Affiliation': 'Department of Epidemiology, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Howard', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Elsayed Z', 'Initials': 'EZ', 'LastName': 'Soliman', 'Affiliation': 'Epidemiological Cardiology Research Center, Division of Cardiology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""Dell Medical School, Dean's Office, University of Texas at Austin, Austin.""}]",JAMA neurology,['10.1001/jamaneurol.2020.0010']
790,31018869,Effects of a footwear intervention on foot pain and disability in people with gout: a randomised controlled trial.,"BACKGROUND


There is limited evidence supporting the long-term effect of a foot care package that includes footwear for people with gout. The aim of this study was to investigate the effectiveness of a footwear intervention on foot pain and disability in people with gout over 6 months.
METHODS


Participants with gout (n = 94) were randomly allocated to either a control group (podiatric care and gout education) or footwear intervention group (podiatric care and gout education plus a commercially available athletic shoe). Measurements were undertaken at baseline and 2, 4, and 6 months. Primary outcome was foot pain severity. Secondary outcomes were overall pain, foot impairment/disability, footwear comfort, fit, ease and weight. Data were analysed using repeated measures models.
RESULTS


Baseline foot pain scores were low, and no differences in foot pain scores were observed between groups over 6 months (adjusted effect estimate: - 6.7, 95% CI - 16.4 to 2.9, P = 0.17). Improvements between groups in overall pain scores (adjusted effect estimate: - 13.2, 95% CI - 22.2 to - 4.3, P < 0.01) and foot impairment/disability scores (- 4.7, 95% CI - 9.1 to - 0.3, P = 0.04) favouring the footwear intervention were observed at 2 months, but not at 4 or 6 months. Improvements between groups in footwear fit (adjusted effect estimate: - 11.1, 95% CI - 21.1 to - 1.0, P = 0.03), ease (- 13.2, 95% CI - 23.8 to - 2.7, P = 0.01) and weight (- 10.3, 95% CI - 19.8 to - 0.8, P = 0.03) favouring the footwear intervention were also observed over 6 months. Similar improvements were observed for footwear comfort at 2 and 4 months. No other differences in secondary outcomes measured were observed at 6 months (P > 0.05).
CONCLUSIONS


Addition of footwear to a foot care package did not improve foot pain in people with gout. Short-term improvements in overall pain and foot impairment/disability and more durable improvements in footwear comfort and fit were observed with the footwear intervention.
TRIAL REGISTRATION


ACTRN12614000209695. Registered 27 February 2014, http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12614000209695&isBasic=True.",2019,"Improvements between groups in footwear fit (adjusted effect estimate: - 11.1, 95% CI - 21.1 to - 1.0, P = 0.03), ease (- 13.2, 95% CI - 23.8 to - 2.7, P = 0.01) and weight (- 10.3, 95% CI - 19.8 to - 0.8, P = 0.03) favouring the footwear intervention were also observed over 6 months.","['people with gout', 'people with gout over 6\xa0months', 'Participants with gout (n\u2009=\u200994']","['footwear intervention', 'control group (podiatric care and gout education) or footwear intervention group (podiatric care and gout education plus a commercially available athletic shoe']","['overall pain and foot impairment/disability', 'overall pain scores', 'Baseline foot pain scores', 'foot pain scores', 'foot pain severity', 'foot impairment/disability scores', 'overall pain, foot impairment/disability, footwear comfort, fit, ease and weight', 'foot pain', 'foot pain and disability', 'weight']","[{'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0336894', 'cui_str': 'Footwear (physical object)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3266521', 'cui_str': 'Gout education (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0185506', 'cui_str': 'Shoeing'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0016512', 'cui_str': 'Foot pain (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0336894', 'cui_str': 'Footwear (physical object)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",,0.252563,"Improvements between groups in footwear fit (adjusted effect estimate: - 11.1, 95% CI - 21.1 to - 1.0, P = 0.03), ease (- 13.2, 95% CI - 23.8 to - 2.7, P = 0.01) and weight (- 10.3, 95% CI - 19.8 to - 0.8, P = 0.03) favouring the footwear intervention were also observed over 6 months.","[{'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Frecklington', 'Affiliation': 'Health and Rehabilitation Research Institute, AUT University, Private Bag 92006, Auckland, 1142, New Zealand. mike.frecklington@aut.ac.nz.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Dalbeth', 'Affiliation': 'Department of Medicine, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McNair', 'Affiliation': 'Health and Rehabilitation Research Institute, AUT University, Private Bag 92006, Auckland, 1142, New Zealand.'}, {'ForeName': 'Trish', 'Initials': 'T', 'LastName': 'Morpeth', 'Affiliation': 'Health and Rehabilitation Research Institute, AUT University, Private Bag 92006, Auckland, 1142, New Zealand.'}, {'ForeName': 'Alain C', 'Initials': 'AC', 'LastName': 'Vandal', 'Affiliation': 'Department of Biostatistics & Epidemiology, AUT University, Auckland, New Zealand.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gow', 'Affiliation': 'Counties Manukau District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Rome', 'Affiliation': 'Health and Rehabilitation Research Institute, AUT University, Private Bag 92006, Auckland, 1142, New Zealand.'}]",Arthritis research & therapy,['10.1186/s13075-019-1886-y']
791,32155254,Feasibility and preliminary effectiveness of group antenatal care in Senegalese health posts: a pilot implementation trial.,"Almost all pregnant women in Senegal receive some antenatal care (ANC), yet only around half receive four or more visits and provision of education and counselling during ANC is often inadequate and, in some cases, non-existent. This results in missed opportunities to provide support and to counsel women regarding appropriate care-seeking practices and health behaviours during pregnancy and across the continuum of care. This pilot effectiveness-implementation randomized controlled trial explored whether group ANC (G-ANC), a model that integrates standard individual pregnancy care with facilitated participatory group education activities and peer support, could potentially address some of these challenges. The G-ANC model adapted for Senegal builds on local healthcare delivery systems and aligns with World Health Organization recommendations for a shift towards women-centred models of maternity services. It was implemented at the health post level, and a total of 330 pregnant women participated in the study, of whom 85% were followed up at 6-10 weeks post-delivery. We assessed implementation outcomes (e.g. acceptability, cost) to establish the feasibility of the model in Senegal and explored effectiveness outcomes related to maternal and infant health for the planning of a large-scale trial. Results indicate that women and ANC providers were overwhelmingly enthusiastic about the G-ANC model, and exploratory analyses suggested improvements in exclusive breastfeeding, intention to use family planning, birth preparations and knowledge around maternal and newborn danger signs. This article provides timely and relevant evidence on the feasibility of G-ANC as an alternative model of care during pregnancy and a solid basis for recommending the conduct of a large-scale implementation study of G-ANC in Senegal.",2020,The G-ANC model adapted for Senegal builds on local healthcare delivery systems and aligns with World Health Organization recommendations for a shift towards women-centred models of maternity services.,"['330 pregnant women', 'Senegalese health posts', 'pregnant women in Senegal receive some antenatal care (ANC', ""six health posts in Senegal's Kaolack district""]","['group ANC (G-ANC', 'Key Messages Group antenatal care (G-ANC', 'G-ANC']","['exclusive breastfeeding, intention to use family planning, birth preparations and knowledge around maternal and newborn danger signs']","[{'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0337846', 'cui_str': 'Senegalese (ethnic group)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0036644', 'cui_str': 'Republic of Senegal'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}]","[{'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0009861', 'cui_str': 'Family Planning Services'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0311392', 'cui_str': 'Sign'}]",330.0,0.0342214,The G-ANC model adapted for Senegal builds on local healthcare delivery systems and aligns with World Health Organization recommendations for a shift towards women-centred models of maternity services.,"[{'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'McKinnon', 'Affiliation': 'Centre for Global Child Health, The Hospital for Sick Children, 686 Bay Street, Toronto, ON M5G 0A4, Canada.'}, {'ForeName': 'Mohamadou', 'Initials': 'M', 'LastName': 'Sall', 'Affiliation': 'Institut de Recherche et Formation en Population, Développement et Santé de la Reproduction, Université Cheik Anta Diop, P.O. Box 45 550 Dakar Fann, Dakar, Senegal.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Vandermorris', 'Affiliation': 'Division of Adolescent Medicine, The Hospital for Sick Children, 686 Bay Street, Toronto, ON M5G 0A4, Canada.'}, {'ForeName': 'Mahamadou', 'Initials': 'M', 'LastName': 'Traoré', 'Affiliation': 'Institut de Recherche et Formation en Population, Développement et Santé de la Reproduction, Université Cheik Anta Diop, P.O. Box 45 550 Dakar Fann, Dakar, Senegal.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Lamesse-Diedhiou', 'Affiliation': 'Institut de Recherche et Formation en Population, Développement et Santé de la Reproduction, Université Cheik Anta Diop, P.O. Box 45 550 Dakar Fann, Dakar, Senegal.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'McLaughlin', 'Affiliation': 'Centre for Global Child Health, The Hospital for Sick Children, 686 Bay Street, Toronto, ON M5G 0A4, Canada.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Bassani', 'Affiliation': 'Centre for Global Child Health, The Hospital for Sick Children, 686 Bay Street, Toronto, ON M5G 0A4, Canada.'}]",Health policy and planning,['10.1093/heapol/czz178']
792,31543954,Does handwriting the name of a potential trial participant on an invitation letter improve recruitment rates? A randomised controlled study within a trial.,"Background:  Randomised controlled trials (RCTs) often fail to recruit to target, resulting in a lack of generalisability of findings. A wide range of strategies for potentially increasing recruitment have been identified; however, their effectiveness has not been established. The aim of this study within a trial (SWAT) was to evaluate the effectiveness of handwritten personalisation of an invitation letter as part of a trial recruitment pack on recruitment to a host RCT.  Methods:  A pragmatic, two-armed RCT was conducted, embedded within an existing falls prevention trial (OTIS) in men and women aged 65 years and over living in the community. Participants were randomised 1:1 to receive an OTIS recruitment pack containing an invitation letter on which their name was handwritten (intervention group), or one on which it was printed (control group). The primary outcome was randomisation into the host trial.  Secondary outcomes related to trial eligibility and retention.  Analyses were via logistic regression and Cox Proportional Hazards regression.  Results:  Of the 317 SWAT participants, 12 (3.8%) were randomised into the OTIS trial: 3 (handwritten: 3/159 [1.9%]; printed: 9/158 [5.7%]; difference -3.8%, 95% CI -8.0% to 0.4%). There was weak evidence, against the intervention, of a difference in the likelihood of participants being randomised into the host trial between the two groups (OR 0.32, 95% CI 0.08 to 1.20, p=0.09). There were no statistically significant differences between the intervention and control groups on any of the secondary outcomes.  Conclusions:  There was no evidence that personalisation of invitation letters improved recruitment to the OTIS trial. However, due to the small sample size, the results should be interpreted with caution. These findings need to be replicated across larger studies and wider populations.  Registration:  ISRCTN22202133.",2019,"There was weak evidence, against the intervention, of a difference in the likelihood of participants being randomised into the host trial between the two groups (OR 0.32, 95% CI 0.08 to 1.20, p=0.09).","['317 SWAT participants, 12 (3.8', 'men and women aged 65 years and over living in the community']","['OTIS recruitment pack containing an invitation letter on which their name was handwritten (intervention group), or one on which it was printed (control group']","['personalisation of invitation letters', 'trial eligibility and retention']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",,0.478752,"There was weak evidence, against the intervention, of a difference in the likelihood of participants being randomised into the host trial between the two groups (OR 0.32, 95% CI 0.08 to 1.20, p=0.09).","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McCaffery', 'Affiliation': 'Department of Health Sciences, University of York, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Mitchell', 'Affiliation': 'Department of Health Sciences, University of York, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': 'Department of Health Sciences, University of York, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cockayne', 'Affiliation': 'Department of Health Sciences, University of York, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Rodgers', 'Affiliation': 'Department of Health Sciences, University of York, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Relton', 'Affiliation': 'SCHARR, University of Sheffield, Sheffield, South Yorkshire, S1 4DA, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Torgerson', 'Affiliation': 'Department of Health Sciences, University of York, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",F1000Research,['10.12688/f1000research.18939.1']
793,31122969,"Melatonin, temazepam and placebo in hospitalised older patients with sleeping problems (MATCH): a study protocol of randomised controlled trial.","INTRODUCTION


Hospitalised older patients frequently suffer from inadequate sleep, which can lead to patient distress and delayed recovery from acute illness or surgical procedure. Currently, no evidence-based treatments exist for sleeping problems in hospitalised older patients. Benzodiazepines, such as temazepam, are regularly prescribed by physicians, although they have serious side effects; for older patients in particular. Melatonin is proposed as a safe alternative for sleeping problems in hospitalised older patients, but the efficacy of melatonin is unclear in this population. Therefore, the aim of this study is to investigate the effects of melatonin and temazepam compared with placebo on sleep quality among hospitalised older patients with sleeping problems.
METHODS AND ANALYSIS


This study is a multicentre, randomised, placebo-controlled trial. A total of 663 patients will be randomised in a 1:1:1 fashion to receive either melatonin (n=221), temazepam (n=221) or placebo (n=221). The study population consists of hospitalised patients aged 60 years and older, with new or aggravated sleeping problems for which an intervention is needed. The primary outcome is sleep quality measured with the Leeds Sleep Evaluation Questionnaire (LSEQ). Secondary outcomes include sleep parameters measured with actigraphy and medication-related adverse effects.
ETHICS AND DISSEMINATION


This study was approved by the Medical Ethics Committee of the Academic Medical Centre Amsterdam, (No 2015_302). Study findings will be disseminated through presentations at professional and scientific conferences and publications in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NTR6908; Pre-results.",2019,"Melatonin is proposed as a safe alternative for sleeping problems in hospitalised older patients, but the efficacy of melatonin is unclear in this population.","['hospitalised patients aged 60 years and older, with new or aggravated sleeping problems for which an intervention is needed', 'older patients in particular', 'hospitalised older patients', 'hospitalised older patients with sleeping problems (MATCH', 'hospitalised older patients with sleeping problems', '663 patients', 'Hospitalised older patients frequently suffer from inadequate sleep']","['melatonin', 'placebo', 'Benzodiazepines', 'melatonin and temazepam', 'Melatonin, temazepam and placebo', 'temazepam', 'Melatonin', 'temazepam (n=221) or placebo']","['sleep parameters measured with actigraphy and medication-related adverse effects', 'sleep quality measured with the Leeds Sleep Evaluation Questionnaire (LSEQ', 'sleep quality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0039468', 'cui_str': 'Temazepam'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",663.0,0.474364,"Melatonin is proposed as a safe alternative for sleeping problems in hospitalised older patients, but the efficacy of melatonin is unclear in this population.","[{'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Stenveld', 'Affiliation': 'Department of Geriatric Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Sjanne', 'Initials': 'S', 'LastName': 'Bosman', 'Affiliation': 'Department of Geriatric Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'van Munster', 'Affiliation': 'Department of Geriatric Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Beishuizen', 'Affiliation': 'Department of Internal Medicine, Geriatrics Section, Amsterdam Public Health, Academic Medical Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Hempenius', 'Affiliation': 'Department of Geriatric Medicine, Medical Centre Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'van der Velde', 'Affiliation': 'Department of Internal Medicine, Geriatrics Section, Amsterdam Public Health, Academic Medical Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'Nynke', 'Initials': 'N', 'LastName': 'Smidt', 'Affiliation': 'Department of Geriatric Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Sophia E', 'Initials': 'SE', 'LastName': 'de Rooij', 'Affiliation': 'Department of Geriatric Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2018-025514']
794,31083056,Blended Collaborative Care to Treat Heart Failure and Comorbid Depression: Rationale and Study Design of the Hopeful Heart Trial.,"OBJECTIVE


Despite numerous improvements in care, morbidity from heart failure (HF) has remained essentially unchanged in recent years. One potential reason is that depression, which is comorbid in approximately 40% of hospitalized HF patients and associated with adverse HF outcomes, often goes unrecognized and untreated. The Hopeful Heart Trial is the first study to evaluate whether a widely generalizable telephone-delivered collaborative care program for treating depression in HF patients improves clinical outcomes.
METHODS


The Hopeful Heart Trial aimed to enroll 750 patients with reduced ejection fraction (HFrEF) (ejection fraction ≤ 45%) including the following: (A) 625 patients who screened positive for depression both during their hospitalization (Patient Health Questionnaire [PHQ-2]) and two weeks following discharge (PHQ-9 ≥ 10); and (B) 125 non-depressed control patients (PHQ-2(-)/PHQ-9 < 5). We randomized depressed patients to either their primary care physician's ""usual care"" (UC) or to one of two nurse-delivered 12-month collaborative care programs for (a) depression and HFrEF (""blended"") or (b) HrEFF alone (enhanced UC). Our co-primary hypotheses will test whether ""blended"" care can improve mental health-related quality of life versus UC and versus enhanced UC, respectively, on the Mental Component Summary of the Short-Form 12 Health Survey. Secondary hypotheses will evaluate the effectiveness of our interventions on mood, functional status, hospital readmissions, deaths, provision of evidence-based care for HFrEF, and treatment costs.
RESULTS


Not applicable.
CONCLUSIONS


The Hopeful Heart Trial will determine whether ""blended"" collaborative care for depression and HFrEF is more effective at improving patient-relevant outcomes than collaborative care for HFrEF alone or doctors' UC for HFrEF.
TRIAL REGISTRATION


ClinicalTrials.gov identifier NCT02044211.",2019,"Our co-primary hypotheses will test whether ""blended"" care can improve mental health-related quality of life versus UC and versus enhanced UC, respectively, on the Mental Component Summary of the Short-Form 12 Health Survey.","['depressed patients to either their primary care physician\'s ""usual care"" (UC) or to one of two nurse-delivered 12-month', '750 patients with reduced ejection fraction (HFrEF) (ejection fraction ≤ 45%) including the following: (A) 625 patients who screened positive for depression both during their hospitalization (Patient Health Questionnaire [PHQ-2]) and two weeks following discharge (PHQ-9 ≥ 10); and (B) 125 non-depressed control patients (PHQ-2(-)/PHQ-9 < 5']","['Blended Collaborative Care', 'collaborative care programs for (a) depression and HFrEF (""blended"") or (b) HrEFF alone (enhanced UC', 'generalizable telephone-delivered collaborative care program']","['mood, functional status, hospital readmissions, deaths, provision of evidence-based care for HFrEF, and treatment costs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033131', 'cui_str': 'Primary Care Physicians'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C4517838', 'cui_str': 'Six hundred and twenty-five'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}]",750.0,0.153453,"Our co-primary hypotheses will test whether ""blended"" care can improve mental health-related quality of life versus UC and versus enhanced UC, respectively, on the Mental Component Summary of the Short-Form 12 Health Survey.","[{'ForeName': 'Bea', 'Initials': 'B', 'LastName': 'Herbeck Belnap', 'Affiliation': 'From the Division of General Internal Medicine (Herbeck Belnap, Anderson, Abebe, Rollman), and Center for Behavioral Health and Smart Technology (Herbeck Belnap, Anderson, Rollman), University of Pittsburgh School of Medicine, Pittsburgh, PA; Department of Psychosomatic Medicine and Psychotherapy (Herbeck Belnap), University of Göttingen Medical Center, Göttingen, Germany; and Center for Clinical Trials & Data Coordination (Abebe), Cardiovascular Institute (Ramani, Muldoon), and Department of Psychiatry (Karp), University of Pittsburgh School of Medicine, Pittsburgh, PA. www.healthtech.pitt.edu and @HealthTechPitt.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'Kaleab Z', 'Initials': 'KZ', 'LastName': 'Abebe', 'Affiliation': ''}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Ramani', 'Affiliation': ''}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Muldoon', 'Affiliation': ''}, {'ForeName': 'Jordan F', 'Initials': 'JF', 'LastName': 'Karp', 'Affiliation': ''}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Rollman', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000706']
795,31243712,A Novel Dual-Frequency Deep Brain Stimulation Paradigm for Parkinson's Disease.,"INTRODUCTION


Deep brain stimulation (DBS) of the subthalamic nucleus (STN) using high-frequency (130-185 Hz) stimulation (HFS) is more effective for appendicular than for axial symptoms. Low-frequency stimulation (LFS) of the STN may reduce gait/balance and speech impairment but can result in worsened appendicular symptoms, limiting its clinical usefulness. A novel dual-frequency paradigm (interleave-interlink, IL-IL) was created in order to reduce gait/balance and speech impairment while maintaining appendicular symptom control in Parkinson's disease (PD) patients chronically stimulated with DBS.
METHODS


Two overlapping LFS programs are applied to each DBS lead, with the overlapping area focused around the optimal electrode contact. As a result, this area receives HFS, controlling appendicular symptoms. The non-overlapping area receives LFS, potentially reducing gait/balance and speech impairment. Patients were separated into three categories based on their chief complaint(s): gait/balance impairment, speech impairment, and/or incomplete PD symptom control. The Clinical- Global Impression of Change scale (CGI-C) was completed retrospectively based on patient/caregiver feedback in patients who remained on IL-IL (at 3 months and at the last follow-up).
RESULTS


Seventy-six patients were switched from optimized HFS to IL-IL. Fifty-five (72%) patients remained on IL-IL after 22 ± 8.7 months. The median (range) CGI-C for gait was 2 (1-5) at 3 months and 3 (1-4) at last follow-up, for dysarthria it was 4 (1-4) at 3 months and 4 (1-5) at last follow-up, and for PD motor it was 2 (1-3) at 3 months and 2 (1-3) at last follow-up.
CONCLUSION


A substantial number of patients remained on IL-IL because of subjective improvements in gait/balance, speech, or PD symptoms. A prospective, double-blind, crossover study with objective/quantitative outcome measures is underway.",2019,"A substantial number of patients remained on IL-IL because of subjective improvements in gait/balance, speech, or PD symptoms.","['Seventy-six patients', ""Parkinson's disease (PD) patients chronically stimulated with DBS"", ""Parkinson's Disease"", 'Patients were separated into three categories based on their chief complaint(s): gait/balance impairment, speech impairment, and/or incomplete PD symptom control']","['Novel Dual-Frequency Deep Brain Stimulation Paradigm', 'Deep brain stimulation (DBS) of the subthalamic nucleus (STN) using high-frequency (130-185\xa0Hz) stimulation (HFS', 'Low-frequency stimulation (LFS) of the STN']","['Clinical- Global Impression of Change scale (CGI-C', 'gait/balance and speech impairment', 'gait/balance, speech, or PD symptoms', 'median (range) CGI-C for gait']","[{'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0241981', 'cui_str': 'Unable to balance (finding)'}, {'cui': 'C0233715', 'cui_str': 'Speech abnormality'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0394162', 'cui_str': 'Deep Brain Stimulation'}, {'cui': 'C0152355', 'cui_str': 'Nucleus Subthalamicus'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0233715', 'cui_str': 'Speech abnormality'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",76.0,0.0257422,"A substantial number of patients remained on IL-IL because of subjective improvements in gait/balance, speech, or PD symptoms.","[{'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Karl', 'Affiliation': 'Movement Disorder Section of Neurological Sciences, Rush University Medical Center, 1725\xa0W. Harrison Street, Suite 755, Chicago, IL, 60612, USA. jessica_karl@rush.edu.'}, {'ForeName': 'Bichun', 'Initials': 'B', 'LastName': 'Ouyang', 'Affiliation': 'Movement Disorder Section of Neurological Sciences, Rush University Medical Center, 1725\xa0W. Harrison Street, Suite 755, Chicago, IL, 60612, USA.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Verhagen Metman', 'Affiliation': 'Movement Disorder Section of Neurological Sciences, Rush University Medical Center, 1725\xa0W. Harrison Street, Suite 755, Chicago, IL, 60612, USA.'}]",Neurology and therapy,['10.1007/s40120-019-0140-5']
796,31061026,Effects of native language on CPR skills and willingness to intervene in out-of-hospital cardiac arrest after film-based basic life support training: a subgroup analysis of a randomised trial.,"OBJECTIVES


The aim was to investigate whether the students' native language, Swedish as native language (SNL) versus other native language (ONL), affects cardiopulmonary resuscitation (CPR) skills or willingness to act after film-based training in Swedish.
SETTING


13-year-old students in two municipalities.
DESIGN


A subgroup from a previous randomised study was analysed. During 2013 to 2014, a film-based CPR method was evaluated. Practical skills and willingness to act were assessed directly after training and after 6 months. CPR skills were evaluated using a modified Cardiff test.
PARTICIPANTS


A total of 641 students were included in the analysis (SNL, n=499; ONL, n=142).
PRIMARY AND SECONDARY OUTCOME MEASURES


Primary endpoint was the total score of the modified Cardiff test at 6 months. The secondary endpoints were total score directly after training, individual variables for the test and self-reported willingness to act.
RESULTS


At the practical test, SNL students scored better than ONL students; directly after training, 67% vs 61% of maximum score, respectively (p<0.001); at 6 months, 61% vs 56% of maximum score (p<0.001). Most students were willing to perform compressions and ventilation on a friend (SNL 85% vs ONL 84%). However, if the victim was a stranger, ONL students were more willing to perform both compressions and ventilation than SNL students (52% vs 38% after training, p<0.001; 42% vs 31% at 6 months, p=0.032). SNL students preferred to initiate chest compressions only.
CONCLUSIONS


SNL students scored slightly higher in the practical CPR skill test than ONL students. Willingness to act was generally high, however ONL students reported higher willingness to perform both compressions and ventilation if the victim was a stranger. Further research is needed to investigate how CPR educational material should be designed and simplified for optimal learning by students. Different language versions or including feedback in CPR training can be a way to increase learning.
ETHICS APPROVAL


The study was approved by the Regional Ethical Review Board of Linköping, Sweden (2013/358-31).
TRIAL REGISTRATION NUMBER


NCT03233490; Pre-results.",2019,"Willingness to act was generally high, however ONL students reported higher willingness to perform both compressions and ventilation if the victim was a stranger.","['13-year-old students in two municipalities', 'A total of 641 students were included in the analysis (SNL, n=499; ONL, n=142']","['film-based basic life support training', 'native language', 'feedback in CPR training', ""students' native language, Swedish as native language (SNL) versus other native language (ONL"", 'cardiopulmonary resuscitation (CPR) skills or willingness to act after film-based training in Swedish']","['total score of the modified Cardiff test', 'total score directly after training, individual variables for the test and self-reported willingness to act', 'practical CPR skill test', 'CPR skills']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0600182'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085873', 'cui_str': 'Basic life support (procedure)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}]",641.0,0.0643642,"Willingness to act was generally high, however ONL students reported higher willingness to perform both compressions and ventilation if the victim was a stranger.","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Hollenberg', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Claesson', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Ringh', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Nordberg', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Ingela', 'Initials': 'I', 'LastName': 'Hasselqvist-Ax', 'Affiliation': ''}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Nord', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2018-025531']
797,31095263,Clinical Performance Evaluation of a Personal Sound Amplification Product vs a Basic Hearing Aid and a Premium Hearing Aid.,"Importance


Hearing loss is a highly prevalent condition with multiple negative associated outcomes, yet few persons with hearing loss have hearing aids (HAs). Personal sound amplification products (PSAPs) could be an alternative low-cost solution to HAs, but data are lacking on the performance of PSAPs.
Objective


To evaluate the clinical efficacy of a PSAP by comparing its performance with that of a basic HA and a premium HA in participants with mild, moderate, and moderately severe hearing impairment.
Design, Setting, and Participants


A prospective, single-institution cohort study was performed with a total of 56 participants, including 19 with mild hearing loss, 20 with moderate hearing loss, and 17 with moderately severe hearing loss. All participants underwent 4 clinical hearing tests with each of the PSAP, basic HA, and premium HA, and all completed an evaluative questionnaire.
Interventions


All hearing devices (PSAP, basic HA, and premium HA) were applied by a clinician to prevent bias and order effects; participants were blinded to the device in use, and sequence of devices was randomized.
Main Outcomes and Measures


The study used the Korean version of the hearing in noise test, the speech intelligibility in noise test, listening effort measurement using a dual-task paradigm, pupillometry, and a self-rating questionnaire regarding sound quality and preference. These tests were administered under the following 4 hearing conditions: unaided hearing, use of PSAP, use of basic HA, and use of premium HA.
Results


The study included 56 participants with a mean age of 56 years (interquartile range, 48-59 years); 29 (52%) were women. In the mild and moderate hearing loss groups, there was no meaningful difference between PSAP, basic HA, and premium HA for speech perception (Cohen d = 0.06-1.05), sound quality (Cohen d = 0.06-0.71), listening effort (Cohen d = 0.10-0.92), and user preference (PSAP, 41%; basic HA, 28%; premium HA, 31%). However, for the patients with moderately severe hearing loss, the premium HA had better performance across most tests (Cohen d = 0.60-1.59), and 70% of participants preferred to use the premium HA.
Conclusions and Relevance


The results indicate that basic and premium HAs were not superior to the PSAP in patients with mild to moderate hearing impairment, which suggests that PSAPs might be used as an alternative to HAs in these patient populations. However, if hearing loss is more severe, then HAs, especially premium HAs, should be considered as an option to manage hearing loss.",2019,"The results indicate that basic and premium HAs were not superior to the PSAP in patients with mild to moderate hearing impairment, which suggests that PSAPs might be used as an alternative to HAs in these patient populations.","['All participants underwent 4 clinical hearing tests with each of the PSAP, basic HA, and premium HA, and all completed an evaluative questionnaire', 'patients with mild to moderate hearing impairment', '56 participants, including 19 with mild hearing loss, 20 with moderate hearing loss, and 17 with moderately severe hearing loss', 'participants with mild, moderate, and moderately severe hearing impairment', '56 participants with a mean age of 56 years (interquartile range, 48-59 years); 29 (52%) were women']","['Personal sound amplification products (PSAPs', 'PSAP', 'Personal Sound Amplification Product vs a Basic Hearing Aid and a Premium Hearing Aid']","['PSAP, basic HA, and premium HA for speech perception', 'sound quality', 'listening effort']","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C3874334', 'cui_str': 'Severe hearing loss (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0018768', 'cui_str': 'Hearing Aids'}]","[{'cui': 'C0037826', 'cui_str': 'Speech Perception'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}]",56.0,0.0479195,"The results indicate that basic and premium HAs were not superior to the PSAP in patients with mild to moderate hearing impairment, which suggests that PSAPs might be used as an alternative to HAs in these patient populations.","[{'ForeName': 'Young Sang', 'Initials': 'YS', 'LastName': 'Cho', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Su Yeon', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Hearing Research Laboratory, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Hye Yoon', 'Initials': 'HY', 'LastName': 'Seol', 'Affiliation': 'Hearing Research Laboratory, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Ji Hyun', 'Initials': 'JH', 'LastName': 'Lim', 'Affiliation': 'Center for Clinical Epidemiology, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Yang-Sun', 'Initials': 'YS', 'LastName': 'Cho', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Sung Hwa', 'Initials': 'SH', 'LastName': 'Hong', 'Affiliation': 'Hearing Research Laboratory, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Il Joon', 'Initials': 'IJ', 'LastName': 'Moon', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South Korea.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2019.0667']
798,31226342,Facts or stories? How to use social media for cervical cancer prevention: A multi-method study of the effects of sender type and content type on increased message sharing.,"Social media has become a valuable tool for disseminating cancer prevention information. However, the design of messages for achieving wide dissemination remains poorly understood. We conducted a multi-method study to identify the effects of sender type (individuals or organizations) and content type (personal experiences or factual information) on promoting the spread of cervical cancer prevention messages over social media. First, we used observational Twitter data to examine correlations between sender type and content type with retweet activity. Then, to confirm the causal impact of message properties, we constructed 900 experimental tweets according to a 2 (sender type) by 2 (content type) factorial design and tested their probabilities of being shared in an online platform. A total of 782 female participants were randomly assigned to 87 independent 9-person online groups and each received a unique message feed of 100 tweets drawn from the 4 experimental cells over 5 days. We conducted both tweet-level and group-level analyses to examine the causal effects of tweet properties on influencing sharing behaviors. Personal experience tweets and organizational senders were associated with more retweets. However, the experimental study revealed that informational tweets were shared significantly more (19%, 95% CI: 11 to 27) than personal experience tweets; and organizational senders were shared significantly more (10%, 95% CI: 3 to 18) than individual senders. While rare personal experience messages can achieve large success, they are generally unsuccessful; however, there is a reproducible causal effect of messages that use organizational senders and factual information for achieving greater peer-to-peer dissemination.",2019,Personal experience tweets and organizational senders were associated with more retweets.,['782 female participants'],['sender type (individuals or organizations) and content type (personal experiences or factual information'],['organizational senders'],"[{'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C4319824', 'cui_str': 'Content type (foundation metadata concept)'}]",[],782.0,0.0323419,Personal experience tweets and organizational senders were associated with more retweets.,"[{'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'University of California, Davis, Department of Communication, One Shields Avenue, Davis, CA 95616, USA.'}, {'ForeName': 'Gem', 'Initials': 'G', 'LastName': 'Le', 'Affiliation': 'University of California San Francisco, Center for Vulnerable Populations, Division of General Internal Medicine, San Francisco, CA 94143, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Larochelle', 'Affiliation': 'University of Pennsylvania, Annenberg School for Communication, 3620 Walnut Street, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Rena', 'Initials': 'R', 'LastName': 'Pasick', 'Affiliation': 'University of California San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco, CA 94143, USA.'}, {'ForeName': 'George F', 'Initials': 'GF', 'LastName': 'Sawaya', 'Affiliation': 'University of California San Francisco, Department of Obstetrics and Gynecology, San Francisco, CA 94143, USA.'}, {'ForeName': 'Urmimala', 'Initials': 'U', 'LastName': 'Sarkar', 'Affiliation': 'University of California San Francisco, Center for Vulnerable Populations, Division of General Internal Medicine, San Francisco, CA 94143, USA.'}, {'ForeName': 'Damon', 'Initials': 'D', 'LastName': 'Centola', 'Affiliation': 'University of Pennsylvania, Annenberg School for Communication, 3620 Walnut Street, Philadelphia, PA 19104, USA. Electronic address: dcentola@asc.upenn.edu.'}]",Preventive medicine,['10.1016/j.ypmed.2019.105751']
799,31286906,A pragmatic randomised trial of two counselling models at the Swedish national alcohol helpline.,"BACKGROUND


Alcohol telephone helplines targeting alcohol consumers in the general population can extend the reach of brief interventions while preserving in-person counselling. So far, studies of client outcomes in the setting of alcohol helplines are scarce. This study aims to compare the 6-months alcohol-related outcomes of two counselling models delivered at the Swedish National Alcohol Helpline.
METHODS


A pragmatic randomised trial was set up at the Swedish National Alcohol Helpline. First-time callers with current hazardous or harmful alcohol use who contacted the helpline, from May 2015 to December 2017, were invited to participate. Clients were allocated with 1:1 ratio to two groups: (1) brief, structured intervention (n = 128), including self-help material and one counsellor-initiated call, and (2) usual care (n = 133), i.e. multiple-session counselling using Motivational Interviewing (MI). The primary outcome was a downward change in AUDIT risk-zone between baseline and 6-months follow-up. The analysis followed an intention-to-treat approach.
RESULTS


Recruitment ended in December 2017. At 6-months follow-up, 70% of the enrolled participants had data on the outcome. In the brief, structured intervention (n = 107) 68% changed to a lower risk-level, compared to 61% in the usual care group (n = 117), yielding a risk ratio (RR) of 1.12 (95% CI 0.93 to 1.37) and risk difference of 0.08 (95% CI -0.05 to 0.20). The total AUDIT score and the scores from the AUDIT consumption questions (AUDIT-C) did not reveal any between-group differences in the mean change at follow-up.
CONCLUSIONS


The counselling at the Swedish National Alcohol Helpline was followed by a significant decrease in alcohol use among clients, without clear superiority for either counselling model.
TRIAL REGISTRATION


This trial was retrospectively registered with ISRCNT.com (ID: ISRCTN13160878 ) 18/01/2016.",2019,"The counselling at the Swedish National Alcohol Helpline was followed by a significant decrease in alcohol use among clients, without clear superiority for either counselling model.
","['two counselling models at the Swedish national alcohol helpline', 'Swedish National Alcohol Helpline', 'First-time callers with current hazardous or harmful alcohol use who contacted the helpline, from May 2015 to December 2017, were invited to participate']","['structured intervention (n\xa0=\u2009128), including self-help material and one counsellor-initiated call, and (2) usual care (n\xa0=\u2009133), i.e. multiple-session counselling using Motivational Interviewing (MI']",['downward change in AUDIT risk-zone'],"[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]","[{'cui': 'C0205104', 'cui_str': 'Down (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.109609,"The counselling at the Swedish National Alcohol Helpline was followed by a significant decrease in alcohol use among clients, without clear superiority for either counselling model.
","[{'ForeName': 'Eleonor', 'Initials': 'E', 'LastName': 'Säfsten', 'Affiliation': 'Department of Public Health Sciences, Karolinska Institutet, 171 77, Stockholm, Sweden. eleonor.safsten@ki.se.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Forsell', 'Affiliation': 'Department of Public Health Sciences, Karolinska Institutet, 171 77, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Ramstedt', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, 171 77, Stockholm, Sweden.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Damström Thakker', 'Affiliation': 'Centre for Epidemiology and Community Medicine, Stockholm Health Care District, Stockholm County Council, 104 31, Stockholm, Sweden.'}, {'ForeName': 'Maria Rosaria', 'Initials': 'MR', 'LastName': 'Galanti', 'Affiliation': 'Department of Public Health Sciences, Karolinska Institutet, 171 77, Stockholm, Sweden.'}]",BMC psychiatry,['10.1186/s12888-019-2199-z']
800,30928969,Effect of communicating phenotypic and genetic risk of coronary heart disease alongside web-based lifestyle advice: the INFORM Randomised Controlled Trial.,"OBJECTIVE


To determine whether provision of web-based lifestyle advice and coronary heart disease risk information either based on phenotypic characteristics or phenotypic plus genetic characteristics affects changes in objectively measured health behaviours.
METHODS


A parallel-group, open randomised trial including 956 male and female blood donors with no history of cardiovascular disease (mean [SD] age=56.7 [8.8] years) randomised to four study groups: control group (no information provided); web-based lifestyle advice only (lifestyle group); lifestyle advice plus information on estimated 10-year coronary heart disease risk based on phenotypic characteristics (phenotypic risk estimate) (phenotypic group) and lifestyle advice plus information on estimated 10-year coronary heart disease risk based on phenotypic (phenotypic risk estimate) and genetic characteristics (genetic risk estimate) (genetic group). The primary outcome was change in physical activity from baseline to 12 weeks assessed by wrist-worn accelerometer.
RESULTS


928 (97.1%) participants completed the trial. There was no evidence of intervention effects on physical activity (difference in adjusted mean change from baseline): lifestyle group vs control group 0.09 milligravity (mg) (95% CI -1.15 to 1.33); genetic group vs phenotypic group -0.33 mg (95% CI -1.55 to 0.90); phenotypic group and genetic group vs control group -0.52 mg (95% CI -1.59 to 0.55) and vs lifestyle group -0.61 mg (95% CI -1.67 to 0.46). There was no evidence of intervention effects on secondary biological, emotional and health-related behavioural outcomes except self-reported fruit and vegetable intake.
CONCLUSIONS


Provision of risk information, whether based on phenotypic or genotypic characteristics, alongside web-based lifestyle advice did not importantly affect objectively measured levels of physical activity, other health-related behaviours, biological risk factors or emotional well-being.
TRIAL REGISTRATION NUMBER


ISRCTN17721237; Pre-results.",2019,"There was no evidence of intervention effects on secondary biological, emotional and health-related behavioural outcomes except self-reported fruit and vegetable intake.
","['956 male and female blood donors with no history of cardiovascular disease (mean [SD] age=56.7 [8.8] years', '928 (97.1%) participants completed the trial']","['control group (no information provided); web-based lifestyle advice only (lifestyle group); lifestyle advice plus information on estimated 10-year coronary heart disease risk based on phenotypic characteristics (phenotypic risk estimate) (phenotypic group) and lifestyle advice plus information on estimated 10-year coronary heart disease risk based on phenotypic (phenotypic risk estimate) and genetic characteristics (genetic risk estimate) (genetic group', 'coronary heart disease alongside web-based lifestyle advice']","['change in physical activity', 'wrist-worn accelerometer', 'physical activity, other health-related behaviours, biological risk factors or emotional well-being', 'physical activity', 'secondary biological, emotional and health-related behavioural outcomes except self-reported fruit and vegetable intake']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0005795', 'cui_str': 'Blood donor (person)'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517882', 'cui_str': '8.8 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1277690', 'cui_str': 'Coronary heart disease risk'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}]","[{'cui': 'C0851408', 'cui_str': 'Changes in physical activity'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0237121', 'cui_str': 'Health-related behavior (observable entity)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}]",956.0,0.214895,"There was no evidence of intervention effects on secondary biological, emotional and health-related behavioural outcomes except self-reported fruit and vegetable intake.
","[{'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'Silarova', 'Affiliation': 'MRC Epidemiology Unit, School of Clinical Medicine, Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sharp', 'Affiliation': 'MRC Epidemiology Unit, School of Clinical Medicine, Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Juliet A', 'Initials': 'JA', 'LastName': 'Usher-Smith', 'Affiliation': 'Department of Public Health and Primary Care, The Primary Care Unit, Cambridge, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Lucas', 'Affiliation': 'Department of Public Health and Primary Care, MRC/BHF Cardiovascular Epidemiology Unit, Cambridge, UK.'}, {'ForeName': 'Rupert A', 'Initials': 'RA', 'LastName': 'Payne', 'Affiliation': 'University of Bristol Centre for Academic Primary Care, Bristol, Bristol, UK.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Shefer', 'Affiliation': 'MRC Epidemiology Unit, School of Clinical Medicine, Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Carmel', 'Initials': 'C', 'LastName': 'Moore', 'Affiliation': 'Department of Public Health and Primary Care, MRC/BHF Cardiovascular Epidemiology Unit, Cambridge, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Girling', 'Affiliation': 'Patient and Public Involvement representative, Cambridge, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Lawrence', 'Affiliation': 'Patient and Public Involvement representative, Cambridge, UK.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Tolkien', 'Affiliation': 'Department of Public Health and Primary Care, MRC/BHF Cardiovascular Epidemiology Unit, Cambridge, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Walker', 'Affiliation': 'Department of Public Health and Primary Care, MRC/BHF Cardiovascular Epidemiology Unit, Cambridge, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Butterworth', 'Affiliation': 'Department of Public Health and Primary Care, MRC/BHF Cardiovascular Epidemiology Unit, Cambridge, UK.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Di Angelantonio', 'Affiliation': 'Department of Public Health and Primary Care, MRC/BHF Cardiovascular Epidemiology Unit, Cambridge, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Danesh', 'Affiliation': 'Department of Public Health and Primary Care, MRC/BHF Cardiovascular Epidemiology Unit, Cambridge, UK.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': 'MRC Epidemiology Unit, School of Clinical Medicine, Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2018-314211']
801,30984388,Using pens as an incentive for trial recruitment of older adults: An embedded randomised controlled trial.,"Background : Meeting recruitment targets for randomised controlled trials is challenging.  This trial evaluated the effectiveness of including a pen within the trial invitation pack on the recruitment of older adults into a randomised controlled trial.  Methods : This trial was embedded within the Occupational Therapist Intervention Study, a falls-prevention randomised controlled trial.  Potential participants (n = 1862), who were posted an invitation pack from two General Practitioner practices, were randomised to either not receive a pen (n = 1295) or receive a pen (n = 648) with their invitation pack, using a 2:1 ratio.  The primary outcome was the likelihood of being randomised, and therefore fully recruited, to the host trial.  To be randomised to the host trial, participants had to: return a consent form and screening form; be eligible on their screening form; and return a baseline questionnaire and a monthly falls calendar.  Secondary outcomes were: the likelihood of returning (and time to return) a screening form; being eligible for the host trial; and remaining in the trial for at least 3 months.  Results : The likelihood of being randomised to the host trial did not differ between the pen group (4.5%) and no pen group (4.3%; odds ratio 1.04; 95% confidence interval: 0.65 to 1.67;  p  = 0.86).  There were marginal differences in secondary outcomes in favour of the pen group, particularly in screening form return rates, though these differences were not statistically significant.  Conclusion : Pens may not be an effective incentive for the recruitment of older adults into randomised controlled trials, though future trials are required.  Registration:  ISRCTN22202133; SWAT 37.",2019,"There were marginal differences in secondary outcomes in favour of the pen group, particularly in screening form return rates, though these differences were not statistically significant.  ","['Potential participants (n = 1862), who were posted an invitation pack from two General Practitioner practices', 'participants had to: return a consent form and screening form; be eligible on their screening form; and return a baseline questionnaire and a monthly falls calendar', 'older adults']",[' '],['likelihood of returning (and time to return) a screening form; being eligible for the host trial'],"[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0009797', 'cui_str': 'Informed Consent Documents'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1516147', 'cui_str': 'Calendar'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0376315', 'cui_str': 'Form'}]",648.0,0.391683,"There were marginal differences in secondary outcomes in favour of the pen group, particularly in screening form return rates, though these differences were not statistically significant.  ","[{'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Whiteside', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Flett', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Mitchell', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cockayne', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Rodgers', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",F1000Research,['10.12688/f1000research.18300.1']
802,30999929,"Efficacy and safety of namilumab, a human monoclonal antibody against granulocyte-macrophage colony-stimulating factor (GM-CSF) ligand in patients with rheumatoid arthritis (RA) with either an inadequate response to background methotrexate therapy or an inadequate response or intolerance to an anti-TNF (tumour necrosis factor) biologic therapy: a randomized, controlled trial.","BACKGROUND


Namilumab (AMG203), an immunoglobulin G1 monoclonal antibody that binds with high affinity to granulocyte-macrophage colony-stimulating factor (GM-CSF), was evaluated in a phase II randomized, double-blind, placebo-controlled study to investigate the efficacy and safety in patients with rheumatoid arthritis (RA) with an inadequate response to methotrexate (MTX-IR) or anti-tumour necrosis factor therapy (TNF-IR).
METHODS


Subcutaneous namilumab (20, 80, or 150 mg) or placebo was administered at baseline and weeks 2, 6, and 10 in patients on stable background methotrexate therapy who were with MTX-IR or TNF-IR. Primary endpoint was mean change from baseline in the 28-joint Disease Activity Score, C-reactive protein version (DAS28-CRP) at week 12 comparing each of the three doses of namilumab to placebo. Safety and tolerability were assessed by adverse events (AEs) and pulmonary parameters. Results were analysed using the per-protocol population.
RESULTS


One hundred eight patients from Europe and Japan (48.4 ± 12.02 years old; 77.8% female; mean DAS28-CRP 5.60-5.79; rheumatoid factor/anti-citrullinated protein antibodies + 75%) were randomized to placebo or namilumab 20, 80, or 150 mg (n = 27, 28, 25, and 28, respectively). Ninety-two were MTX-IR; 16 were TNF-IR. At week 12, a statistically significant difference in DAS28-CRP (p = 0.005) was seen for namilumab 150 mg versus placebo and separation was seen as early as week 2 for namilumab 150 mg (p < 0.05), with higher ACR50 and response rates versus placebo at week 12. A dose-response effect was observed across the DAS28-CRP endpoint with separation versus placebo evident from week 2. The most common treatment-emergent AEs were nasopharyngitis (18.5%, 17.9%, 4.0%, 14.3%), dyspnoea (0.0%, 3.6%, 8.0%, 10.7%), bronchitis (7.4%, 3.6%, 4.0%, 3.6%), and headache (3.7%, 3.6%, 12.0%, 0.0%) for placebo and 20, 80, or 150 mg of namilumab, respectively. No serious infections were observed. One serious AE (myocardial infarction) was observed with 150 mg of namilumab. There was no apparent dose relationship for AEs. A biomarker-based disease activity score showed a dose-dependent decrease at week 12.
CONCLUSIONS


This phase II study demonstrates the benefit of inhibiting macrophage activity targeting the GM-CSF for RA. The study met its primary endpoint with a clear dose-response effect. An acceptable tolerability profile was demonstrated over the 12-week study.
TRIAL REGISTRATION


ClinicalTrials.gov, NEXUS; NCT02379091 , submitted November 28, 2014.",2019,"At week 12, a statistically significant difference in DAS28-CRP (p = 0.005) was seen for namilumab 150 mg versus placebo and separation was seen as early as week 2 for namilumab 150 mg (p < 0.05), with higher ACR50 and response rates versus placebo at week 12.","['patients with rheumatoid arthritis (RA', 'One hundred eight patients from Europe and Japan (48.4\u2009±\u200912.02\u2009years old; 77.8% female; mean DAS28-CRP 5.60-5.79; rheumatoid factor/anti-citrullinated protein antibodies +\u200975']","['namilumab, a human monoclonal antibody against granulocyte-macrophage colony-stimulating factor ', 'methotrexate therapy', 'placebo', 'placebo or namilumab', 'stable background methotrexate therapy who were with MTX-IR or TNF-IR', 'methotrexate (MTX-IR) or anti-tumour necrosis factor therapy (TNF-IR']","['adverse events (AEs) and pulmonary parameters', 'serious infections', 'mean change from baseline in the 28-joint Disease Activity Score, C-reactive protein version (DAS28-CRP', 'nasopharyngitis', 'DAS28-CRP', 'headache', 'ACR50 and response rates', 'bronchitis', 'efficacy and safety', 'dyspnoea', 'Safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0201660', 'cui_str': 'Rheumatoid factor measurement (procedure)'}, {'cui': 'C4505301', 'cui_str': 'Citrullinated Protein Antibodies'}]","[{'cui': 'C3273714', 'cui_str': 'namilumab'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0006277', 'cui_str': 'Bronchitis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}]",108.0,0.258654,"At week 12, a statistically significant difference in DAS28-CRP (p = 0.005) was seen for namilumab 150 mg versus placebo and separation was seen as early as week 2 for namilumab 150 mg (p < 0.05), with higher ACR50 and response rates versus placebo at week 12.","[{'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Taylor', 'Affiliation': 'Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Windmill Road, Oxford, OX3 7LD, UK. peter.taylor@kennedy.ox.ac.uk.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Saurigny', 'Affiliation': 'Takeda Development Centre, London, UK.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Vencovsky', 'Affiliation': 'Institute of Rheumatology, Prague, Czech Republic.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Rheumatology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Kumamoto Shinto General Hospital, Kumamoto, Japan.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Matsievskaia', 'Affiliation': 'Clinical Rheumatology Hospital #25, Saint-Petersburg, Russian Federation.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hunt', 'Affiliation': 'Statistics, Takeda International, Deerfield, IL, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wagner', 'Affiliation': 'Modeling and Simulation, Takeda Pharmaceuticals International GmbH, Zurich, Switzerland.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Souberbielle', 'Affiliation': 'Takeda Development Centre, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Arthritis research & therapy,['10.1186/s13075-019-1879-x']
803,30831180,Both increases and decreases in energy density lead to sustained changes in preschool children's energy intake over 5 days.,"BACKGROUND AND OBJECTIVE


To investigate preschool children's ability to self-regulate their energy intake, we assessed their response to increases or decreases in dietary energy density (ED) over 5 consecutive days, a period likely long enough for compensatory behavior.
METHODS


Using a crossover design, over 3 periods we served the same 5 daily menus to 49 children aged 3-5 y in their childcare centers. During each 5-day period, 3 main dishes and 1 snack per day were systematically varied in ED, from baseline ED to either higher ED (increased by 20%) or lower ED (decreased by 20%). All of the served items were weighed to determine individual intakes.
RESULTS


Modifying the ED of 4 dishes per day had a significant and sustained effect on preschool children's daily energy intake across 5 days. In the baseline condition, children's intakes were similar to daily energy needs (98 ± 2%), but serving higher-ED foods increased energy intake by 84 ± 16 kcal/d (to 105 ± 2% of needs) and serving lower-ED foods decreased energy intake by 72 ± 17 kcal/d (to 89 ± 2% of needs; both P < .0001). The patterns of daily energy intake over the 5 days did not differ across conditions (P = .20), thus there was no evidence that either surfeits or deficits in energy intake led to adjustment over this time period. Furthermore, the response to ED varied, as children with a higher weight status had greater amounts of overconsumption when served higher-ED foods and of underconsumption when served lower-ED foods compared to children with a lower weight status.
CONCLUSIONS


These findings counter the suggestion that preschool children's regulatory systems can be relied on to adjust intake in response to energy imbalances. Increasing or decreasing the ED of several foods per day leads to sustained changes in the energy intake of preschool children.",2019,"The patterns of daily energy intake over the 5 days did not differ across conditions (P = .20), thus there was no evidence that either surfeits or deficits in energy intake led to adjustment over this time period.","['preschool children', ""preschool children's"", '49 children aged 3-5 y in their childcare centers']",[],"['dietary energy density (ED', 'energy intake', 'energy density', ""preschool children's daily energy intake""]","[{'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",[],"[{'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",49.0,0.10082,"The patterns of daily energy intake over the 5 days did not differ across conditions (P = .20), thus there was no evidence that either surfeits or deficits in energy intake led to adjustment over this time period.","[{'ForeName': 'Alissa D', 'Initials': 'AD', 'LastName': 'Smethers', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Liane S', 'Initials': 'LS', 'LastName': 'Roe', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Sanchez', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Faris M', 'Initials': 'FM', 'LastName': 'Zuraikat', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Kathleen L', 'Initials': 'KL', 'LastName': 'Keller', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA; Department of Food Science, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Rolls', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA. Electronic address: bjr4@psu.edu.'}]",Physiology & behavior,['10.1016/j.physbeh.2019.02.042']
804,31407191,Can Generic Intravenous Levetiracetam Be Used for Acute Repetitive Convulsive Seizure or Status Epilepticus? A Randomized Controlled Trial.,"INTRODUCTION


Intravenous levetiracetam (IV LEV) is approved for treatment status epilepticus (SE). However, the drug's high cost must be considered when deciding on a treatment strategy. This study aimed to compare the efficacy of brand-name and generic IV LEV for acute repetitive convulsive seizure (ARCS) or SE.
METHODS


Forty patients aged 18 years or older who had been diagnosed with SE or ARCS were included in this double-blind study. Patients were randomly assigned at a 1:1 ratio (via computer-generated code) to receive either brand-name or generic IV LEV. The primary outcomes were seizure control and the number of seizure exacerbations during the 24 h after drug administration, while the secondary outcomes were electroencephalographic (EEG) findings, serious adverse events, and clinical outcome at hospital discharge.
RESULTS


Forty patients were randomly assigned administration with either brand-name IV LEV (10 SE and 10 ARCS patients) or generic IV LEV; 7 SE and 13 ARCS patients). There was no significant difference in patients' baseline characteristics. The seizure control rate was 75% in the brand-name IV LEV group and 65% in the generic IV LEV group (p value: 0.490). Five (25%) patients in the brand-name IV LEV group, and six (30%) patients in the generic IV LEV group developed seizure exacerbations within 24 h after drug administration (p value 0.723). There were no reports of drug-related adverse events. Two of the patients taking brand-name IV LEV and one taking the generic IV LEV died (p value > 0.999).
CONCLUSION


Treatment with the generic IV LEV had comparable outcomes with brand-name IV LEV. The generic IV LEV may be an alternative medication for the treatment of SE and ARCS to reduce treatment costs.
TRIAL REGISTRATION


TCTR20190513001.
FUNDING


Great Eastern Drug Company.",2019,The seizure control rate was 75% in the brand-name IV LEV group and 65% in the generic IV LEV group (p value: 0.490).,"['Forty patients aged 18\xa0years or older who had been diagnosed with SE or ARCS were included in this double-blind study', 'Forty patients']","['generic IV LEV', 'brand-name or generic IV LEV', 'brand-name and generic IV LEV', 'brand-name IV LEV', 'levetiracetam (IV LEV']","['seizure exacerbations', 'seizure control rate', 'electroencephalographic (EEG) findings, serious adverse events, and clinical outcome at hospital discharge', 'seizure control and the number of seizure exacerbations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001857', 'cui_str': 'Lymphadenopathy Syndrome'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013072', 'cui_str': 'Double-Masked Method'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",40.0,0.0950176,The seizure control rate was 75% in the brand-name IV LEV group and 65% in the generic IV LEV group (p value: 0.490).,"[{'ForeName': 'Rachot', 'Initials': 'R', 'LastName': 'Wongjirattikarn', 'Affiliation': 'Department of Medicine, Faculty of Medicine, and Integrated Epilepsy Research Group, Khon Kaen University, Khon Kaen, 40002, Thailand.'}, {'ForeName': 'Kittisak', 'Initials': 'K', 'LastName': 'Sawanyawisuth', 'Affiliation': 'Department of Medicine, Faculty of Medicine, and North-eastern Stroke Research Group, Research Center in Back, Neck, Other Joint Pain and Human Performance (BNOJPH), Research and Training Center for Enhancing Quality of Life of Working Age People, and Research and Diagnostic Center for Emerging Infectious Diseases (RCEID), Khon Kaen University, Khon Kaen, 40002, Thailand.'}, {'ForeName': 'Sineenard', 'Initials': 'S', 'LastName': 'Pranboon', 'Affiliation': 'Nursing Division, Faculty of Medicine, Srinagarind Hospital, Khon Kaen University, Khon Kaen, 40002, Thailand.'}, {'ForeName': 'Siriporn', 'Initials': 'S', 'LastName': 'Tiamkao', 'Affiliation': 'Department of Pharmacy, Faculty of Medicine, Khon Kaen University, Khon Kaen, 40002, Thailand.'}, {'ForeName': 'Somsak', 'Initials': 'S', 'LastName': 'Tiamkao', 'Affiliation': 'Department of Medicine, Faculty of Medicine, and Integrated Epilepsy Research Group, Khon Kaen University, Khon Kaen, 40002, Thailand. somtia@kku.ac.th.'}]",Neurology and therapy,['10.1007/s40120-019-00150-x']
805,31788029,Spray on skin for diabetic foot ulcers: an open label randomised controlled trial.,"Background


One Australian loses a limb every 3 h as a result of infected diabetic foot ulcers (DFU). This common condition accounts for substantial morbidity and mortality for affected individuals and heavy economic costs for the health sector and the community. There is an urgent need to test interventions that improve wound healing time, prevent amputations and recurrent ulceration in patients presenting with DFU whilst improving quality of life and reducing health care costs.
Methods


One hundred and fifty eligible participants will be randomised to receive an autologous skin cell suspension, also termed 'spray-on' skin (ReCell®) or standard care interventions for their DFU. The primary outcome is complete wound healing at 6 months, but participants will be followed up for a total of 12 months to enable secondary outcomes including total overall costs, ulcer free days at 12 months and quality of life to be assessed.
Discussion


Outpatient costs for dressings, home nursing visits and outpatient appointments are key cost drivers for DFU. If spray-on skin is effective, large cost savings to WA Health will be realised immediately through a shortened time to healing, and through a higher proportion of patients achieving complete healing. Shortened healing times may enable participants to return to work earlier. Any economic benefits are likely to be amplified across Australia and other similar demographic settings where aging populations with increased diabetes rates are considered major future challenges.
Trial registration


Australian New Zealand Clinical Trials Registry ACTRN12618000511235. Registered on 9 April 2018.",2019,"There is an urgent need to test interventions that improve wound healing time, prevent amputations and recurrent ulceration in patients presenting with DFU whilst improving quality of life and reducing health care costs.
","['diabetic foot ulcers', 'One hundred and fifty eligible participants']","[""autologous skin cell suspension, also termed 'spray-on' skin (ReCell®) or standard care interventions for their DFU"", 'Spray']","['wound healing time', 'total overall costs, ulcer free days at 12\u2009months and quality of life to be assessed', 'complete wound healing', 'Shortened healing times']","[{'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0814995', 'cui_str': 'Skin cell'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}]",150.0,0.112913,"There is an urgent need to test interventions that improve wound healing time, prevent amputations and recurrent ulceration in patients presenting with DFU whilst improving quality of life and reducing health care costs.
","[{'ForeName': 'Laurens', 'Initials': 'L', 'LastName': 'Manning', 'Affiliation': '1Department of Infectious Diseases, Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, WA 6150 Australia.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Hamilton', 'Affiliation': '2Endocrinology Department, Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, WA 6150 Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Raby', 'Affiliation': '1Department of Infectious Diseases, Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, WA 6150 Australia.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Norman', 'Affiliation': '3Medical School, University of Western Australia, Crawley, WA 6009 Australia.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Davis', 'Affiliation': '3Medical School, University of Western Australia, Crawley, WA 6009 Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Wood', 'Affiliation': '5State Burns Unit, Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, WA 6150 Australia.'}, {'ForeName': 'Keryln', 'Initials': 'K', 'LastName': 'Carville', 'Affiliation': '6Silver Chain Group and School of Nursing and Midwifery, Curtin University, Bentley, WA 6102 Australia.'}, {'ForeName': 'Mendel', 'Initials': 'M', 'LastName': 'Baba', 'Affiliation': '7Podiatry Department, Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, WA 6150 Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hiew', 'Affiliation': '7Podiatry Department, Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, WA 6150 Australia.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Ryan', 'Affiliation': '7Podiatry Department, Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, WA 6150 Australia.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Ferreira', 'Affiliation': '7Podiatry Department, Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, WA 6150 Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gittings', 'Affiliation': '8Burns Department, Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, WA 6150 Australia.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Ritter', 'Affiliation': '9Department of Vascular Surgery, Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, WA 6150 Australia.'}]",Journal of foot and ankle research,['10.1186/s13047-019-0362-x']
806,31372936,"Bioavailability and Pharmacokinetics of Once-Daily Amantadine Extended-Release Tablets in Healthy Volunteers: Results from Three Randomized, Crossover, Open-Label, Phase 1 Studies.","INTRODUCTION


In February 2018, OS320-an amantadine extended-release (ER) tablet formulation with once-daily morning administration-was approved for the treatment of Parkinson's disease and drug-induced extrapyramidal reactions in adults. The purpose of this study was to describe three phase 1 studies that assessed the pharmacokinetics (PK) and bioavailability of amantadine ER in healthy adult volunteers.
METHODS


Study 1 was an open-label, four-treatment, single-dose, crossover study comparing amantadine ER 129, 193, and 258 mg tablets with an equivalent dose of immediate-release (IR) amantadine 40 mg/5 mL syrup. Study 2 was an open-label, single-dose, crossover food-effect study with amantadine ER 258 mg. Study 3 was an open-label, multiple-dose, crossover study comparing amantadine ER and amantadine IR syrup.
RESULTS


Amantadine ER displayed a steady release of amantadine, with the peak amantadine concentration occurring at ~ 7.5 h postdose or in the middle of the day (following a morning dose) with steady-state administration. Administration of amantadine ER 258 mg with a high-fat meal did not affect amantadine bioavailability. Amantadine plasma exposure increased proportionally with increasing doses, and at steady state, amantadine exposure from an amantadine ER 258-mg tablet was bioequivalent to twice-daily 129-mg amantadine IR syrup.
CONCLUSION


The PK profile of amantadine ER 129-mg, 193-mg, and 258-mg tablets allows for once-daily dosing in the morning; the 24-h average amantadine plasma concentration is equivalent to that for the same daily dose of IR amantadine administered twice daily.
FUNDING


Osmotica Pharmaceutical US LLC.",2019,"Amantadine plasma exposure increased proportionally with increasing doses, and at steady state, amantadine exposure from an amantadine ER 258-mg tablet was bioequivalent to twice-daily 129-mg amantadine IR syrup.
","[""Parkinson's disease and drug-induced extrapyramidal reactions in adults"", 'healthy adult volunteers', 'Healthy Volunteers']","['OS320-an amantadine', 'immediate-release (IR) amantadine 40\xa0mg/5\xa0mL syrup', 'amantadine', 'IR amantadine', 'amantadine ER', 'Amantadine Extended-Release Tablets', 'amantadine ER and amantadine IR syrup', 'Amantadine ER']","['peak amantadine concentration', 'Amantadine plasma exposure', 'Bioavailability and Pharmacokinetics', 'pharmacokinetics (PK) and bioavailability', 'amantadine bioavailability']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0458082', 'cui_str': 'Drug-induced (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0002403', 'cui_str': 'Amantadine'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0458173', 'cui_str': 'Syrup (substance)'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0002403', 'cui_str': 'Amantadine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.0310868,"Amantadine plasma exposure increased proportionally with increasing doses, and at steady state, amantadine exposure from an amantadine ER 258-mg tablet was bioequivalent to twice-daily 129-mg amantadine IR syrup.
","[{'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'deVries', 'Affiliation': 'Osmotica Pharmaceutical US LLC, Bridgewater, NJ, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Dentiste', 'Affiliation': 'Osmotica Pharmaceutical US LLC, Bridgewater, NJ, USA.'}, {'ForeName': 'Lata', 'Initials': 'L', 'LastName': 'Handiwala', 'Affiliation': 'Osmotica Pharmaceutical US LLC, Bridgewater, NJ, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jacobs', 'Affiliation': 'Osmotica Pharmaceutical US LLC, Bridgewater, NJ, USA. djacobs@osmotica.com.'}]",Neurology and therapy,['10.1007/s40120-019-0144-1']
807,31122968,Effects of electrical muscle stimulation in frail elderly patients during haemodialysis (DIAL): rationale and protocol for a crossover randomised controlled trial.,"INTRODUCTION


The phenomenon of population ageing is accompanied by increases in the number of elderly haemodialysis patients worldwide. The incidence of frailty is high in the haemodialysis population and is associated with poor clinical outcome. Although several interventions have been developed for use in general haemodialysis patients, the efficacy of such rehabilitation programmes in frail elderly patients on haemodialysis has not been elucidated. Here, we examined whether electrical muscle stimulation (EMS) would show beneficial effects in frail elderly patients on haemodialysis.
METHODS AND ANALYSIS


This is a randomised, two-period, controlled crossover trial, which will enrol 20 patients. Haemodialysis patients aged ≥65 years and defined as frail (ie, Short Physical Performance Battery score 4-9), will be randomly assigned to either group 1 (EMS intervention beginning in treatment period I, followed by reallocation as controls in treatment period II after a 5-week washout period) or group 2 (opposite schedule) in a 1:1 ratio. The two intervention periods will last 5 weeks each with an intervening washout period of 5 weeks. In the EMS intervention group, the treatment will be applied to the skeletal muscle of the entire lower extremity for 5 weeks, three times/week for 30-40 min during haemodialysis. The primary outcome of this study is the change in quadriceps isometric strength after the interventions. The secondary outcomes are the changes in physical function, physical activity, difficulty in activities of daily living, body composition, cognitive function, depressive symptoms, quality of life, blood test results and the clinical safety and feasibility of EMS therapy.
ETHICS AND DISSEMINATION


This study has been approved by the institutional review board/ethics committee of Kitasato University Allied Health Sciences. This study will be reported in peer reviewed publications and at conference presentations.
TRIAL REGISTRATION NUMBER


UMIN000032501.",2019,"The secondary outcomes are the changes in physical function, physical activity, difficulty in activities of daily living, body composition, cognitive function, depressive symptoms, quality of life, blood test results and the clinical safety and feasibility of EMS therapy.
","['frail elderly patients on haemodialysis', 'Haemodialysis patients aged ≥65 years and defined as frail (ie, Short Physical Performance Battery score 4-9', 'frail elderly patients during haemodialysis (DIAL', 'enrol 20 patients', 'elderly haemodialysis patients worldwide', 'general haemodialysis patients']","['group 1 (EMS intervention', 'electrical muscle stimulation', 'electrical muscle stimulation (EMS']","['changes in physical function, physical activity, difficulty in activities of daily living, body composition, cognitive function, depressive symptoms, quality of life, blood test results and the clinical safety and feasibility of EMS therapy', 'quadriceps isometric strength']","[{'cui': 'C0079377', 'cui_str': 'Frail Elders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score (observable entity)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]","[{'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.0460218,"The secondary outcomes are the changes in physical function, physical activity, difficulty in activities of daily living, body composition, cognitive function, depressive symptoms, quality of life, blood test results and the clinical safety and feasibility of EMS therapy.
","[{'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Rehabilitation Sciences, Kitasato University Graduate School of Medical Sciences, Sagamihara, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kamiya', 'Affiliation': 'Rehabilitation, Kitasato University School of Allied Health Sciences, Sagamihara, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Rehabilitation, Kitasato University School of Allied Health Sciences, Sagamihara, Japan.'}, {'ForeName': 'Keika', 'Initials': 'K', 'LastName': 'Hoshi', 'Affiliation': 'Department of Hygiene, Kitasato University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Rehabilitation Sciences, Kitasato University Graduate School of Medical Sciences, Sagamihara, Japan.'}, {'ForeName': 'Manae', 'Initials': 'M', 'LastName': 'Harada', 'Affiliation': 'Rehabilitation Sciences, Kitasato University Graduate School of Medical Sciences, Sagamihara, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Matsuzawa', 'Affiliation': 'Department of Rehabilitation, Kitasato University Hospital, Sagamihara, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Shimoda', 'Affiliation': 'Rehabilitation Sciences, Kitasato University Graduate School of Medical Sciences, Sagamihara, Japan.'}, {'ForeName': 'Shohei', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Rehabilitation Sciences, Kitasato University Graduate School of Medical Sciences, Sagamihara, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Matsunaga', 'Affiliation': 'Sleep Medicine, Kitasato University Graduate School of Medical Sciences, Sagamihara, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Yoneki', 'Affiliation': 'Rehabilitation Sciences, Kitasato University Graduate School of Medical Sciences, Sagamihara, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Yoshida', 'Affiliation': 'Haemodialysis Center, Sagami Circulatory Organ Clinic, Sagahihara, Japan.'}, {'ForeName': 'Atsuhiko', 'Initials': 'A', 'LastName': 'Matsunaga', 'Affiliation': 'Rehabilitation Sciences, Kitasato University Graduate School of Medical Sciences, Sagamihara, Japan.'}]",BMJ open,['10.1136/bmjopen-2018-025389']
808,31079080,What works best when implementing a physical activity intervention for teenagers? Reflections from the ACTIVE Project: a qualitative study.,"OBJECTIVE


This paper explores what aspects of a multicomponent intervention were deemed strengths and weaknesses by teenagers and the local council when promoting physical activity to young people.
DESIGN


Qualitative findings at 12 months from a mixed method randomised control trial.
METHODS


Active Children Through Incentive Vouchers-Evaluation (ACTIVE) gave teenagers £20 of activity enabling vouchers every month for a year. Peer mentors were also trained and a support worker worked with teenagers to improve knowledge of what was available. Semistructured focus groups took place at 12 months to assess strengths and weaknesses of the intervention. Eight focus groups (n=64 participants) took place with teenagers and one additional focus group was dedicated to the local council's sport development team (n=8 participants). Thematic analysis was used to analyse the data.
RESULTS


Teenagers used the vouchers on three main activities: trampolining, laser tag or the water park. These appeal to both genders, are social, fun and require no prior skill or training. Choice and financial support for teenagers in deprived areas was considered a strength by teenagers and the local council. Teenagers did not engage with a trained peer mentor but the support worker was considered helpful.
CONCLUSIONS


The ACTIVE Project's delivery had both strengths and weakness that could be used to underpin future physical activity promotion. Future interventions should focus on improving access to low cost, fun, unstructured and social activities rather than structured organised exercise/sport. The lessons learnt from this project can help bridge the gap between what is promoted to teenagers and what they actually want from activity provision.
TRIAL REGISTRATION NUMBER


ISRCTN75594310.",2019,"RESULTS


Teenagers used the vouchers on three main activities: trampolining, laser tag or the water park.","['Active Children', 'Eight focus groups (n=64 participants) took place with teenagers and one additional focus group was dedicated to the']","['physical activity intervention', ""local council's sport development team""]",[],"[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C1521910', 'cui_str': 'Teens'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0243107', 'cui_str': 'development'}]",[],64.0,0.0377466,"RESULTS


Teenagers used the vouchers on three main activities: trampolining, laser tag or the water park.","[{'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'James', 'Affiliation': 'College of Medicine, Swansea University, Swansea, UK.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Christian', 'Affiliation': 'Department of Sport and Physical Activity, Edgehill University, Ormskirk, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Scott', 'Affiliation': 'College of Medicine, Swansea University, Swansea, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Todd', 'Affiliation': 'College of Medicine, Swansea University, Swansea, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Stratton', 'Affiliation': 'College of Engineering, Swansea University, Swansea, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Demmler', 'Affiliation': 'College of Medicine, Swansea University, Swansea, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'McCoubrey', 'Affiliation': 'Active Young People Department, City and County of Swansea, Swansea, UK.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Halcox', 'Affiliation': 'College of Medicine, Swansea University, Swansea, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Audrey', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Ellins', 'Affiliation': 'Institute of Life Sciences, Swansea University, Swansea, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Irvine', 'Affiliation': 'College of Medicine, Swansea University, Swansea, UK.'}, {'ForeName': 'Sinead', 'Initials': 'S', 'LastName': 'Brophy', 'Affiliation': 'College of Medicine, Swansea University, Swansea, UK.'}]",BMJ open,['10.1136/bmjopen-2018-025618']
809,32150484,"Effects of  Aster glehni  Extract on Serum Uric Acid in Subjects with Mild Hyperuricemia: A Randomized, Placebo-Controlled Trial.","Aster glehni  extracts (AGE) reduced serum uric acid levels in hyperuricemia rats in several previous studies. However, its efficacy in human has not been yet explored. This study aimed at investigating the efficacy and safety of AGE on the anti-hyperuricemia effect in subjects with slightly high serum uric acid. A randomized, double-blinded, placebo-controlled clinical trial was conducted for 12 weeks. Eligible subjects were randomly assigned to either AGE (480 mg/day) or placebo. The primary endpoint was the change in serum uric acid concentrations from baseline to follow-up time points. The secondary endpoints were the change of serum xanthine oxidase activity, and the levels of C-reactive protein (CRP) and tumor necrosis factor alpha (TNF- α ) in the blood from baseline to follow-up time points. Safety was assessed by clinical laboratory parameters and adverse events reported by subjects. Six weeks of AGE supplementation significantly reduced serum uric acid level from baseline ( P  = .0468) but at the end of the intervention the participants did not show the beneficial effect of AGE supplementation. Also, the serum uric acid level in the AGE group was not significantly different at the follow-up time points, when compared with placebo. The mean changes of secondary endpoints from baseline to each time point did not show significant differences within and between the two groups. There were no adverse events reported by subjects or changes in safety parameters after intervention. In conclusion, AGE supplementation for 12 weeks did not show significant benefits for reducing serum uric acid concentrations in subjects with mild hyperuricemia.",2020,The mean changes of secondary endpoints from baseline to each time point did not show significant differences within and between the two groups.,"['subjects with slightly high serum uric acid', 'hyperuricemia rats', 'subjects with mild hyperuricemia', 'Eligible subjects', 'Subjects with Mild Hyperuricemia']","['Aster glehni  Extract', 'placebo', 'AGE', 'Aster glehni  extracts (AGE', 'Placebo']","['serum uric acid level', 'serum uric acid concentrations', 'Serum Uric Acid', 'change of serum xanthine oxidase activity, and the levels of C-reactive protein (CRP) and tumor necrosis factor alpha (TNF- α ', 'Safety', 'serum uric acid levels', 'change in serum uric acid concentrations']","[{'cui': 'C0750482', 'cui_str': 'Slightly (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}]","[{'cui': 'C0331312', 'cui_str': 'Aster Plant'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0043317', 'cui_str': 'Hypoxanthine Dehydrogenase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.299161,The mean changes of secondary endpoints from baseline to each time point did not show significant differences within and between the two groups.,"[{'ForeName': 'Soyeon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Division of Life Sciences, College of Life Sciences and Biotechnology, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Eun Hye', 'Initials': 'EH', 'LastName': 'Han', 'Affiliation': 'R&D Center, Koreaeundan Healthcare Co., Ansan-si, Republic of Korea.'}, {'ForeName': 'Sang Ho', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'R&D Center, Koreaeundan Healthcare Co., Ansan-si, Republic of Korea.'}, {'ForeName': 'Mi Kyung', 'Initials': 'MK', 'LastName': 'Lim', 'Affiliation': 'R&D Center, Koreaeundan Co., Seongnam-si, Republic of Korea.'}, {'ForeName': 'Chang-O', 'Initials': 'CO', 'LastName': 'Kim', 'Affiliation': 'Clinical Research Center, Yangji Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Seongman', 'Initials': 'S', 'LastName': 'Kang', 'Affiliation': 'Division of Life Sciences, College of Life Sciences and Biotechnology, Korea University, Seoul, Republic of Korea.'}]",Journal of medicinal food,['10.1089/jmf.2019.4513']
810,31655359,DNA epigenetic signature predictive of benefit from neoadjuvant chemotherapy in oesophageal adenocarcinoma: results from the MRC OE02 trial.,"BACKGROUND


DNA methylation signatures describing distinct histological subtypes of oesophageal cancer have been reported. We studied DNA methylation in samples from the MRC OE02 phase III trial, which randomised patients with resectable oesophageal cancer to surgery alone (S) or neoadjuvant chemotherapy followed by surgery (CS).
AIM


The aim of the study was to identify epigenetic signatures predictive of chemotherapy benefit in patients with oesophageal adenocarcinoma (OAC) from the OE02 trial and validate the findings in an independent cohort.
METHODS


DNA methylation was analysed using the Illumina GoldenGate platform on surgically resected OAC specimens from patients in the OE02 trial. Cox proportional hazard analysis was performed to select probes predictive of survival in the CS arm. Non-negative matrix factorisation was used to perform clustering and delineate DNA methylation signatures. The findings were validated in an independent cohort of patients with gastroesophageal adenocarcinoma treated with neoadjuvant chemotherapy.
RESULTS


A total of 229 patients with OAC were analysed from the OE02 trial (118 in the CS arm and 111 in the S arm). There was no difference in DNA methylation status between the CS and S arms. A metagene signature was created by dichotomising samples into two clusters. In cluster 1, patients in the CS arm had significant overall survival (OS) benefit (median OS CS: 931 days vs. S: 536 days [HR: 1.54, P = 0.031]). In cluster 2, patients in the CS arm had similar (or worse) OS compared with patients in the S arm (CS: 348 days vs. S: 472 days [HR: 0.70, P = 0.1], and test of interaction was significant (p = 0.005). In the validation cohort (n = 13), there was no difference in DNA methylation status in paired pre- and post-treatment samples. When the epigenetic signature was applied, cluster 1 samples had better OS (median OS, cluster 1: 1174 days vs. cluster 2: 392 days, HR: 3.47, p = 0.059) CONCLUSIONS: This is the first and largest study of DNA methylation in patients with OAC uniformly treated in a randomised phase III trial. We identified an epigenetic signature that may serve as a predictive biomarker for chemotherapy benefit in OAC.",2019,"When the epigenetic signature was applied, cluster 1 samples had better OS (median OS, cluster 1: 1174 days vs. cluster 2: 392 days, HR: 3.47, p = 0.059)","['229 patients with OAC were analysed from the OE02 trial (118 in the CS arm and 111\xa0in the S arm', 'oesophageal adenocarcinoma', 'patients with resectable oesophageal cancer to surgery alone (S) or neoadjuvant chemotherapy followed by surgery (CS', 'patients with OAC', 'patients with gastroesophageal adenocarcinoma treated with neoadjuvant chemotherapy', 'patients with oesophageal adenocarcinoma (OAC', 'surgically resected OAC specimens from\xa0patients in the OE02 trial']",['neoadjuvant chemotherapy'],"['DNA methylation status', 'overall survival (OS) benefit']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0303403', 'cui_str': 'Indium-111'}, {'cui': 'C0279628', 'cui_str': 'Adenocarcinoma Of Esophagus'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",229.0,0.148295,"When the epigenetic signature was applied, cluster 1 samples had better OS (median OS, cluster 1: 1174 days vs. cluster 2: 392 days, HR: 3.47, p = 0.059)","[{'ForeName': 'Raghav', 'Initials': 'R', 'LastName': 'Sundar', 'Affiliation': 'Department of Haematology-Oncology, National University Health System, Singapore; Cancer and Stem Cell Biology Program, Duke-NUS Medical School, Singapore; Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Ng', 'Affiliation': 'Cancer and Stem Cell Biology Program, Duke-NUS Medical School, Singapore; Centre for Computational Biology, Duke-NUS Medical School, Singapore; NUS Graduate School for Integrative Sciences and Engineering, Singapore.'}, {'ForeName': 'Hermioni', 'Initials': 'H', 'LastName': 'Zouridis', 'Affiliation': 'Cancer and Stem Cell Biology Program, Duke-NUS Medical School, Singapore; Technology Innovation and Delivery Excellence, AstraZeneca, USA.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Padmanabhan', 'Affiliation': 'Cancer and Stem Cell Biology Program, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Taotao', 'Initials': 'T', 'LastName': 'Sheng', 'Affiliation': 'Cancer and Stem Cell Biology Program, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Shenli', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Cancer and Stem Cell Biology Program, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Ming Hui', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Cancer and Stem Cell Biology Program, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Wen Fong', 'Initials': 'WF', 'LastName': 'Ooi', 'Affiliation': 'Cancer and Stem Cell Biology Program, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Qamra', 'Affiliation': 'Cancer and Stem Cell Biology Program, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Inam', 'Affiliation': ""Division of Pathology and Data Analytics, Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'Lindsay C', 'Initials': 'LC', 'LastName': 'Hewitt', 'Affiliation': 'Department of Pathology, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Center+, Maastricht, the Netherlands.'}, {'ForeName': 'Jimmy Bok-Yan', 'Initials': 'JB', 'LastName': 'So', 'Affiliation': 'Department of Surgery, National University Health System, Singapore; Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Koh', 'Affiliation': 'Department of Haematology-Oncology, National University Health System, Singapore; Cancer Science Institute of Singapore, National University of Singapore, Singapore.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Nankivell', 'Affiliation': 'MRC Clinical Trials Unit at University College London, London, UK.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Langley', 'Affiliation': 'MRC Clinical Trials Unit at University College London, London, UK.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Allum', 'Affiliation': 'Department of Surgery, Royal Marsden Hospital, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Department of Medicine, The Royal Marsden NHS Trust, London and Sutton, United Kingdom.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Rozen', 'Affiliation': 'Centre for Computational Biology, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Wei Peng', 'Initials': 'WP', 'LastName': 'Yong', 'Affiliation': 'Department of Haematology-Oncology, National University Health System, Singapore; Cancer Science Institute of Singapore, National University of Singapore, Singapore.'}, {'ForeName': 'Heike I', 'Initials': 'HI', 'LastName': 'Grabsch', 'Affiliation': ""Division of Pathology and Data Analytics, Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK; Department of Pathology, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Center+, Maastricht, the Netherlands. Electronic address: h.grabsch@maastrichtuniversity.nl.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Tan', 'Affiliation': 'Cancer and Stem Cell Biology Program, Duke-NUS Medical School, Singapore; Cancer Science Institute of Singapore, National University of Singapore, Singapore; Biomedical Research Council, Agency for Science, Technology and Research, Singapore; SingHealth/Duke-NUS Institute of Precision Medicine, National Heart Centre Singapore, Singapore. Electronic address: gmstanp@duke-nus.edu.sg.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.09.016']
811,31388222,Assessing the impact of an asset-based intervention on educational outcomes of orphaned children and adolescents: findings from a randomised experiment in Uganda.,"This paper examines the effect of an asset-based intervention on academic performance and school transition among orphaned and vulnerable children in Uganda. Participants were randomly assigned to either the control arm or two treatment arms receiving an asset-based intervention. Participants in the treatment arms scored better grades; and had higher odds of transitioning to post-primary education relative to the control arm. Programmes which target financial insecurity may have a positive impact on the educational achievement and progression of orphaned children. There is a need to consider incorporating asset-based interventions within the development of educational policy, especially in low-income countries.",2019,Participants in the treatment arms scored better grades; and had higher odds of transitioning to post-primary education relative to the control arm.,"['orphaned and vulnerable children in Uganda', 'orphaned children and adolescents']","['control arm or two treatment arms receiving an asset-based intervention', 'asset-based intervention']",['academic performance and school transition'],"[{'cui': 'C0425119', 'cui_str': 'Child at risk (finding)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0036373', 'cui_str': 'Academic Performance'}, {'cui': 'C0036375', 'cui_str': 'School'}]",,0.0422924,Participants in the treatment arms scored better grades; and had higher odds of transitioning to post-primary education relative to the control arm.,"[{'ForeName': 'Nabunya', 'Initials': 'N', 'LastName': 'Proscovia', 'Affiliation': 'Brown School of Social Work, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Namatovu', 'Initials': 'N', 'LastName': 'Phionah', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Damulira', 'Initials': 'D', 'LastName': 'Christopher', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Kivumbi', 'Initials': 'K', 'LastName': 'Apollo', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Byansi', 'Affiliation': 'Brown School of Social Work, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Mukasa', 'Initials': 'M', 'LastName': 'Miriam', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Nattabi', 'Initials': 'N', 'LastName': 'Jennifer', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Ssewamala M', 'Initials': 'SM', 'LastName': 'Fred', 'Affiliation': 'Brown School of Social Work, Washington University in St. Louis, St. Louis, MO, USA.'}]",Asia Pacific journal of social work and development,['10.1080/02185385.2019.1575271']
812,31434161,Integration of a Commercial Barcode-Assisted Medication Dispensing System in a Teaching Hospital.,"OBJECTIVES


A commercial barcode-assisted medication administration (BCMA) system was integrated to secure the medication process and particularly the dispensing stage by technicians and the administration stage with nurses. We aimed to assess the impact of this system on medication dispensing errors and barriers encountered during integration process.
METHODS


We conducted a controlled randomized study in a teaching hospital, during dispensing process at the pharmacy department. Four wards were randomized in the experimental group and control group, with two wards using the system during 3 days with dedicated pharmacy technicians. The system was a closed loop system without information return to the computerized physician order entry system. The two dedicated technicians had a 1-week training session. Observations were performed by one observer among the four potential observers previously trained. The main outcomes assessed were dispensing error rates and the identification of barriers encountered to expose lessons learned from this study.
RESULTS


There was no difference between the dispensing error rate of the control and experimental groups (7.9% for both,  p  = 0.927). We identified 10 barriers to pharmacy barcode-assisted system technology deployment. They concerned technical (problems with semantic interoperability interfaces, bad user interface, false errors generated, lack of barcodes), structural (poor integration with local information technology), work force (short staff training period, insufficient workforce), and strategic issues (system performance problems, insufficient budget).
CONCLUSION


This study highlights the difficulties encountered in integrating a commercial system in current hospital information systems. Several issues need to be taken into consideration before the integration of a commercial barcode-assisted system in a teaching hospital. In our experience, interoperability of this system with the electronic health record is the key for the success of this process with an entire closed loop system from prescription to administration. BCMA system at the dispensing process remains essential to purchase securing medication administration process.",2019,"There was no difference between the dispensing error rate of the control and experimental groups (7.9% for both,  p  = 0.927).",[],"['pharmacy barcode-assisted system technology deployment', 'Commercial Barcode-Assisted Medication Dispensing System', 'commercial barcode-assisted medication administration (BCMA) system']","['dispensing error rate', 'dispensing error rates and the identification of barriers encountered to expose lessons learned from this study']",[],"[{'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C3469597', 'cui_str': 'Medication treatment'}]","[{'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",,0.0504472,"There was no difference between the dispensing error rate of the control and experimental groups (7.9% for both,  p  = 0.927).","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Berdot', 'Affiliation': 'Department of Pharmacy, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Abdelali', 'Initials': 'A', 'LastName': 'Boussadi', 'Affiliation': 'Equipe 22, Centre de Recherche des Cordeliers, UMR 1138 INSERM, Paris, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Vilfaillot', 'Affiliation': 'Unité de Recherche Clinique, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Depoisson', 'Affiliation': 'Department of Pharmacy, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Guihaire', 'Affiliation': 'Hospital Nursing staff (DSAP), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Durieux', 'Affiliation': 'Equipe 22, Centre de Recherche des Cordeliers, UMR 1138 INSERM, Paris, France.'}, {'ForeName': 'Laetitia Minh Maï', 'Initials': 'LMM', 'LastName': 'Le', 'Affiliation': 'Department of Pharmacy, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Sabatier', 'Affiliation': 'Department of Pharmacy, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France.'}]",Applied clinical informatics,['10.1055/s-0039-1694749']
813,30704877,Mortality in the UK STRIDER trial of sildenafil therapy for the treatment of severe early-onset fetal growth restriction.,,2019,,['severe early-onset fetal growth restriction'],['sildenafil therapy'],['Mortality'],"[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0015934', 'cui_str': 'Intrauterine Growth Restriction'}]","[{'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0320241,,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Sharp', 'Affiliation': ""Department of Women's and Children's Health, University of Liverpool, Liverpool, L8 7SS, UK.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Cornforth', 'Affiliation': 'Liverpool Clinical Trials Unit, University of Liverpool, Liverpool, L8 7SS, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Jackson', 'Affiliation': 'Liverpool Clinical Trials Unit, University of Liverpool, Liverpool, L8 7SS, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Harrold', 'Affiliation': 'Liverpool Clinical Trials Unit, University of Liverpool, Liverpool, L8 7SS, UK.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Turner', 'Affiliation': ""Department of Women's and Children's Health, University of Liverpool, Liverpool, L8 7SS, UK.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Kenny', 'Affiliation': ""Department of Women's and Children's Health, University of Liverpool, Liverpool, L8 7SS, UK.""}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Baker', 'Affiliation': 'College of Medicine, University of Leicester, Leicester, UK.'}, {'ForeName': 'Edward D', 'Initials': 'ED', 'LastName': 'Johnstone', 'Affiliation': 'Maternal and Fetal Health Research Centre, Division of Developmental Biology, Faculty of Medicine Biology and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Khalil', 'Affiliation': ""Fetal Medicine Unit, St George's Hospital, and Molecular and Clinical Sciences Research Institute St George's University of London, London, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Women's and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Aris T', 'Initials': 'AT', 'LastName': 'Papageorghiou', 'Affiliation': ""Fetal Medicine Unit, St George's Hospital, and Molecular and Clinical Sciences Research Institute St George's University of London, London, UK.""}, {'ForeName': 'Zarko', 'Initials': 'Z', 'LastName': 'Alfirevic', 'Affiliation': ""Department of Women's and Children's Health, University of Liverpool, Liverpool, L8 7SS, UK. Electronic address: zarko@liverpool.ac.uk.""}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(19)30020-3']
814,31147361,"Multicentre, randomised trial comparing acellular porcine collagen implant versus gluteus maximus myocutaneous flap for reconstruction of the pelvic floor after extended abdominoperineal excision of rectum: study protocol for the Nordic Extended Abdominoperineal Excision (NEAPE) study.","INTRODUCTION


Different surgical techniques are used to cover the defect in the floor of the lesser pelvis after an 'extralevator' or 'extended' abdominoperineal excision for advanced rectal cancer. However, these operations are potentially mutilating, and the reconstruction method of the pelvic floor has been studied only sparsely. We aim to study whether a porcine-collagen implant is superior or equally beneficial to a gluteus maximus myocutaneous flap as a reconstruction method.
METHODS AND ANALYSIS


This is a multicentre non-blinded randomised controlled trial with the experimental arm using a porcine-collagen implant and the control arm using a gluteus maximus muscle and skin rotation flap. Considered for inclusion are patients with rectal cancer, who are operated on with a wide abdominoperineal rectal excision including most of the levator muscles and where the muscle remnants cannot be closed in the midline with sutures. Patients with a primary or recurrent rectal cancer with an estimated survival of more than a year are eligible. The randomisation is computer generated with a concealed sequence and stratified by participating hospital and preoperative radiotherapy regimen. The main outcome is physical performance 6 months after surgery measured with the timed-stands test. Secondary outcomes are perineal wound healing, surgical complications, quality of life, ability to sit and other outcomes measured at 3, 6 and 12 months after surgery. To be able to state experimental arm non-inferiority with a 10% margin of the primary outcome with 90% statistical power and assuming 10% attrition, we aim to enrol 85 patients from May 2011 onwards.
ETHICS AND DISSEMINATION


The study has been approved by the Regional Ethical Review board at Umeå University (protocol no: NEAPE-2010-335-31M). The results will be disseminated through patient associations and conventional scientific channels.
TRIAL REGISTRATION NUMBER


NCT01347697; Pre-results.",2019,"INTRODUCTION


Different surgical techniques are used to cover the defect in the floor of the lesser pelvis after an 'extralevator' or 'extended' abdominoperineal excision for advanced rectal cancer.","['patients with rectal cancer', 'Patients with a primary or recurrent rectal cancer with an estimated survival of more than a year are eligible', 'for reconstruction of the pelvic floor after extended abdominoperineal excision of rectum']","['acellular porcine collagen implant versus gluteus maximus myocutaneous flap', 'abdominoperineal excision', 'Nordic Extended Abdominoperineal Excision (NEAPE', 'porcine-collagen implant', 'abdominoperineal rectal excision', 'porcine-collagen implant and the control arm using a gluteus maximus muscle and skin rotation flap']","['perineal wound healing, surgical complications, quality of life, ability to sit and other outcomes', 'physical performance 6 months after surgery measured with the timed-stands test']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C2004459', 'cui_str': 'Abdominoperineal Excision'}, {'cui': 'C0034896', 'cui_str': 'Rectum'}]","[{'cui': 'C0590992', 'cui_str': 'Collagen implant (substance)'}, {'cui': 'C0438800', 'cui_str': 'Gluteus maximus myocutaneous flap (substance)'}, {'cui': 'C2004459', 'cui_str': 'Abdominoperineal Excision'}, {'cui': 'C0442411', 'cui_str': 'Abdominoperineal approach (qualifier value)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0224424', 'cui_str': 'Structure of gluteus maximus muscle'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C4544575', 'cui_str': 'Rotation flap (substance)'}]","[{'cui': 'C0031066', 'cui_str': 'Perineum'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0034380'}, {'cui': 'C0560879', 'cui_str': 'Ability to sit (observable entity)'}, {'cui': 'C2607857'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.166988,"INTRODUCTION


Different surgical techniques are used to cover the defect in the floor of the lesser pelvis after an 'extralevator' or 'extended' abdominoperineal excision for advanced rectal cancer.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rutegård', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Surgery, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Jörgen', 'Initials': 'J', 'LastName': 'Rutegård', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Surgery, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Markku M', 'Initials': 'MM', 'LastName': 'Haapamäki', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Surgery, Umeå University, Umeå, Sweden.'}]",BMJ open,['10.1136/bmjopen-2018-027255']
815,31142519,Effect of cervical manipulation on vertebral artery and cerebral haemodynamics in patients with chronic neck pain: a crossover randomised controlled trial.,"OBJECTIVE


It is hypothesised that cervical manipulation may increase the risk of cerebrovascular accidents. We aimed to determine whether cervical spine manipulation is associated with changes in vertebral artery and cerebrovascular haemodynamics measured with MRI compared with neutral neck position and maximum neck rotation in patients with chronic neck pain.
SETTING


The Imaging Research Centre at St. Joseph's Hospital in Hamilton, Ontario, Canada.
PARTICIPANTS


Twenty patients were included. The mean age was 32 years (SD ±12.5), mean neck pain duration was 5.3 years (SD ±5.7) and mean neck disability index score was 13/50 (SD ±6.4).
INTERVENTIONS


Following baseline measurement of cerebrovascular haemodynamics, we randomised participants to: (1) maximal neck rotation followed by cervical manipulation or (2) cervical manipulation followed by maximal neck rotation. The primary outcome, vertebral arteries and cerebral haemodynamics, was measured after each intervention and was obtained by measuring three-dimensional T1-weighted high-resolution anatomical images, arterial spin labelling and phase-contrast flow encoded MRI. Our secondary outcome was functional connectivity within the default mode network measured with resting state functional MRI.
RESULTS


Compared with neutral neck position, we found a significant change in contralateral blood flow following maximal neck rotation. There was also a significant change in contralateral vertebral artery blood velocity following maximal neck rotation and cervical manipulation. We found no significant changes within the cerebral haemodynamics following cervical manipulation or maximal neck rotation. However, we observed significant increases in functional connectivity in the posterior cerebrum and cerebellum (resting state MRI) after manipulation and maximum rotation.
CONCLUSION


Our results are in accordance with previous work, which has shown a decrease in blood flow and velocity in the contralateral vertebral artery with head rotation. This may explain why we also observed a decrease in blood velocity with manipulation because it involves neck rotation. Our work is the first to show that cervical manipulation does not result in brain perfusion changes compared with a neutral neck position or maximal neck rotation. The changes observed were found to not be clinically meaningful and suggests that cervical manipulation may not increase the risk of cerebrovascular events through a haemodynamic mechanism.
TRIAL REGISTRATION NUMBER


NCT02667821.",2019,"The changes observed were found to not be clinically meaningful and suggests that cervical manipulation may not increase the risk of cerebrovascular events through a haemodynamic mechanism.
","[""The Imaging Research Centre at St. Joseph's Hospital in Hamilton, Ontario, Canada"", 'patients with chronic neck pain', 'Twenty patients were included']","['maximal neck rotation followed by cervical manipulation or (2) cervical manipulation followed by maximal neck rotation', 'cervical spine manipulation', 'neutral neck position and maximum neck rotation', 'cervical manipulation']","['blood velocity', 'risk of cerebrovascular accidents', 'risk of cerebrovascular events', 'dimensional T1-weighted high-resolution anatomical images, arterial spin labelling and phase-contrast flow encoded MRI', 'functional connectivity', 'vertebral artery and cerebral haemodynamics', 'mean neck pain duration', 'cerebral haemodynamics', 'blood flow and velocity', 'functional connectivity within the default mode network measured with resting state functional MRI', 'contralateral vertebral artery blood velocity', 'vertebral artery and cerebrovascular haemodynamics', 'vertebral arteries and cerebral haemodynamics', 'contralateral blood flow', 'brain perfusion changes', 'mean neck disability index score']","[{'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C4518350', 'cui_str': 'Neck rotation'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0600576', 'cui_str': 'Cervical Manipulation'}, {'cui': 'C0728985', 'cui_str': 'Cervical spine'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C4302506', 'cui_str': 'Neutral neck position (finding)'}]","[{'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0026024', 'cui_str': 'Microscopy, Phase-Contrast'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0042559', 'cui_str': 'Vertebral Artery'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2959538', 'cui_str': 'Neck disability index score'}]",20.0,0.119639,"The changes observed were found to not be clinically meaningful and suggests that cervical manipulation may not increase the risk of cerebrovascular events through a haemodynamic mechanism.
","[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Moser', 'Affiliation': 'Graduate Studies, Canadian Memorial Chiropractic College, Toronto, Ontario, Canada.'}, {'ForeName': 'Silvano', 'Initials': 'S', 'LastName': 'Mior', 'Affiliation': 'Graduate Studies, Canadian Memorial Chiropractic College, Toronto, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Noseworthy', 'Affiliation': 'Radiology, McMaster University Faculty of Engineering, Hamilton, Ontario, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Côté', 'Affiliation': 'Faculty of Health Sciences, University of Ontario Institute of Technology, Oshawa, Ontario, Canada.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Wells', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Behr', 'Affiliation': 'Department of Medicine, Division of Physical Medicine and Rehabilitation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Triano', 'Affiliation': 'Graduate Studies, Canadian Memorial Chiropractic College, Toronto, Ontario, Canada.'}]",BMJ open,['10.1136/bmjopen-2018-025219']
816,32152513,Effects of substituting eggs for high-carbohydrate breakfast foods on the cardiometabolic risk-factor profile in adults at risk for type 2 diabetes mellitus.,"OBJECTIVES


To assess effects of egg-based versus non-egg, higher-carbohydrate (CHO) breakfast meals on cardiometabolic health markers in overweight or obese adults with prediabetes and/or metabolic syndrome.
METHODS


This randomized, crossover study included two 4-week dietary interventions, separated by a ≥4-week washout. Subjects incorporated into their habitual diets breakfast meals containing either 2 eggs/day for 6 days/week (Egg condition), or energy-matched, non-egg, higher-CHO-based foods (Non-Egg condition). Dietary intakes, insulin sensitivity, and other CHO metabolism indices, lipid biomarkers, high-sensitivity C-reactive protein, and blood pressures were measured.
RESULTS


Thirty men and women with mean age 54.1 ± 1.9 years and body mass index 31.9 ± 0.7 kg/m 2  provided data. Neither diet condition significantly altered insulin sensitivity indices, but the homeostasis model assessment for insulin resistance was significantly (p = 0.028) higher after the Non-Egg vs. the Egg condition. Low-density lipoprotein cholesterol (LDL-C) was decreased from baseline (119 mg/dL) by 2.9 and 6.0% with Egg and Non-Egg breakfasts, respectively (p = 0.023). Systolic blood pressure was reduced from baseline (127 mm Hg) by 2.7 and 0.0% with Egg and Non-Egg, respectively (p = 0.018). Diet records indicated 149 kcal/day higher (p = 0.008) energy intake from non-study foods during the Egg condition; however, weight change from baseline did not differ between conditions.
CONCLUSION


Compared with the baseline diet, consumption of 12 eggs/week for 4 weeks at breakfast was associated with less reduction in LDL-C, and more lowering of systolic blood pressure, than observed with non-egg-based, energy-matched, control foods higher in CHO.",2020,"Diet records indicated 149 kcal/day higher (p = 0.008) energy intake from non-study foods during the Egg condition; however, weight change from baseline did not differ between conditions.
","['overweight or obese adults with prediabetes and/or metabolic syndrome', 'Thirty men and women with mean age 54.1\u2009±\u20091.9\u2009years and body mass index 31.9\u2009±\u20090.7\u2009kg/m 2  provided data', 'adults at risk for type 2 diabetes mellitus']","['egg-based versus non-egg, higher-carbohydrate (CHO) breakfast meals']","['lowering of systolic blood pressure', 'Systolic blood pressure', 'Low-density lipoprotein cholesterol (LDL-C', 'Dietary intakes, insulin sensitivity, and other CHO metabolism indices, lipid biomarkers, high-sensitivity C-reactive protein, and blood pressures', 'weight change', 'cardiometabolic risk-factor profile', 'insulin sensitivity indices', 'homeostasis model assessment for insulin resistance', 'cardiometabolic health markers']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517517', 'cui_str': '1.9 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0693838,"Diet records indicated 149 kcal/day higher (p = 0.008) energy intake from non-study foods during the Egg condition; however, weight change from baseline did not differ between conditions.
","[{'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA. kmaki@mbclinicalresearch.com.'}, {'ForeName': 'Orsolya M', 'Initials': 'OM', 'LastName': 'Palacios', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA.'}, {'ForeName': 'Melvyn W', 'Initials': 'MW', 'LastName': 'Kramer', 'Affiliation': 'MB Clinical Research, Boca Raton, FL, USA.'}, {'ForeName': 'Rupal', 'Initials': 'R', 'LastName': 'Trivedi', 'Affiliation': 'Great Lakes Clinical Trials, Chicago, IL, USA.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Dicklin', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Wilcox', 'Affiliation': 'MB Clinical Research, Boca Raton, FL, USA.'}, {'ForeName': 'Cathleen E', 'Initials': 'CE', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA.'}]",European journal of clinical nutrition,['10.1038/s41430-020-0599-2']
817,30659468,The KEEP SIMPLEST Study: Improving In-House Delays and Periinterventional Management in Stroke Thrombectomy-A Matched Pair Analysis.,"BACKGROUND AND PURPOSE


Although the treatment window for mechanical thrombectomy (MT) in patients with acute ischemic stroke (AIS) has been extended in recent years, it has been proven that recanalizing treatment must be administered as soon as possible. We present a new standard operating procedure (SOP) to reduce in-house delay, standardize periinterventional management and improve patient safety during MT.
METHODS


KEep Evaluating Protocol Simplification In Managing Periinterventional Light Sedation for Endovascular Stroke Treatment (KEEP SIMPLEST) was a prospective, single-center observational study aimed to compare aspects of periinterventional management in AIS patients treated according to our new SOP using a combination of esketamine and propofol with patients having been randomized into conscious sedation (CS) in the Sedation versus Intubation for Endovascular Stroke TreAtment (SIESTA) trial. Primary outcome was early neurological improvement at 24h using the National Institutes of Health Stroke Scale, and secondary outcomes were door-to-recanalization, recanalization grade, conversion rate and modified Rankin Scale (mRS) at 3 months.
RESULTS


Door-to-recanalization time (128.6 ± 69.47 min vs. 156.8 ± 75.91 min; p = 0.02), mean duration of MT (92.01 ± 52 min vs. 131.9 ± 64.03 min; p < 0.001), door-to-first angiographic image (51.61 ± 31.7 min vs. 64.23 ± 21.53 min; p = 0.003) and computed tomography-to-first angiographic image time (31.61 ± 20.6 min vs. 44.61 ± 19.3 min; p < 0.001) were significantly shorter in the group treated under the new SOP. There were no differences in early neurological improvement, mRS at 3 months or other secondary outcomes between the groups. Conversion rates of CS to general anesthesia were similar in both groups.
CONCLUSION


An SOP using a novel sedation regimen and optimization of equipment and procedures directed at a leaner, more integrative and compact periinterventional management can reduce in-house treatment delays significantly in stroke patients receiving thrombectomy in light sedation and demonstrated the safety and feasibility of our improved approach.",2019,"There were no differences in early neurological improvement, mRS at 3 months or other secondary outcomes between the groups.","['patients with acute ischemic stroke (AIS', 'stroke patients receiving thrombectomy in light sedation', 'AIS patients treated according to our new SOP using a combination of']","['mechanical thrombectomy (MT', 'esketamine and propofol', 'new standard operating procedure (SOP', 'conscious sedation (CS']","['early neurological improvement at 24h using the National Institutes of Health Stroke Scale, and secondary outcomes were door-to-recanalization, recanalization grade, conversion rate and modified Rankin Scale (mRS', 'Conversion rates of CS to general anesthesia', 'Door-to-recanalization time', 'mean duration of MT', 'early neurological improvement, mRS', 'computed tomography-to-first angiographic image time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C2825616'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0079159', 'cui_str': 'Sedation, Moderate'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0557698', 'cui_str': 'Door (physical object)'}, {'cui': 'C0034771', 'cui_str': 'Recanalization (morphologic abnormality)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]",,0.0504011,"There were no differences in early neurological improvement, mRS at 3 months or other secondary outcomes between the groups.","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Schönenberger', 'Affiliation': 'Department of Neurology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. silvia.schoenenberger@med.uni-heidelberg.de.'}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Weber', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Matthias N', 'Initials': 'MN', 'LastName': 'Ungerer', 'Affiliation': 'Department of Neurology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Pfaff', 'Affiliation': 'Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Schieber', 'Affiliation': 'Department of Neurology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Uhlmann', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Heidenreich', 'Affiliation': 'Department of Neurology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bendszus', 'Affiliation': 'Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Meinhard', 'Initials': 'M', 'LastName': 'Kieser', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Wick', 'Affiliation': 'Department of Neurology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Markus A', 'Initials': 'MA', 'LastName': 'Möhlenbruch', 'Affiliation': 'Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Ringleb', 'Affiliation': 'Department of Neurology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Bösel', 'Affiliation': 'Department of Neurology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}]",Neurocritical care,['10.1007/s12028-018-00667-3']
818,32152811,"Inter-study repeatability of circumferential strain and diastolic strain rate by CMR tagging, feature tracking and tissue tracking in ST-segment elevation myocardial infarction.","Strain assessment allows accurate evaluation of myocardial function and mechanics in ST-segment elevation myocardial infarction (STEMI). Strain using cardiovascular magnetic resonance (CMR) has traditionally been assessed with tagging but limitations of this technique have led to more widespread use of alternative methods, which may be more robust. We compared the inter-study repeatability of circumferential global peak-systolic strain (Ecc) and peak-early diastolic strain rate (PEDSR) derived by tagging with values obtained using novel cine-based software: Feature Tracking (FT) (TomTec, Germany) and Tissue Tracking (TT) (Circle cvi 42 , Canada) in patients following STEMI. Twenty male patients (mean age 56 ± 10 years, mean infarct size 13.7 ± 7.1% of left ventricular mass) were randomised to undergo CMR 1-5 days post-STEMI at 1.5 T or 3.0 T, repeated after ten minutes at the same field strength. Ecc and PEDSR were assessed using tagging, FT and TT. Inter-study repeatability was evaluated using Bland-Altman analyses, coefficients of variation (CoV) and intra-class correlation coefficient (ICC). Ecc (%) was significantly lower with tagging than with FT or TT at 1.5 T (- 9.5 ± 3.3 vs. - 17.5 ± 3.8 vs. -15.5 ± 5.2, respectively, p < 0.001) and 3.0 T (- 13.1 ± 1.8 vs. - 19.4 ± 2.9 vs. - 17.3 ± 2.1, respectively, p = 0.001). This was similar for PEDSR (.s -1 ): 1.5 T (0.6 ± 0.2 vs. 1.5 ± 0.4 vs. 1.0 ± 0.4, for tagging, FT and TT respectively, p < 0.001) and 3.0 T (0.6 ± 0.2 vs. 1.5 ± 0.3 vs. 0.9 ± 0.3, respectively, p < 0.001). Inter-study repeatability for Ecc at 1.5 T was good for tagging and excellent for FT and TT: CoV 16.7%, 6.38%, and 8.65%, respectively. Repeatability for Ecc at 3.0 T was good for all three techniques: CoV 14.4%, 11.2%, and 13.0%, respectively. However, repeatability of PEDSR was generally lower than that for Ecc at 1.5 T (CoV 15.1%, 13.1%, and 34.0% for tagging, FT and TT, respectively) and 3.0 T (CoV 23.0%, 18.6%, and 26.2%, respectively). Following STEMI, Ecc and PEDSR are higher when measured with FT and TT than with tagging. Inter-study repeatability of Ecc is good for tagging, excellent for FT and TT at 1.5 T, and good for all three methods at 3.0 T. The repeatability of PEDSR is good to moderate at 1.5 T and moderate at 3.0 T. Cine-based methods to assess Ecc following STEMI may be preferable to tagging.",2020,Inter-study repeatability for Ecc at 1.5 T was good for tagging and excellent for FT and TT:,"['Twenty male patients (mean age 56\u2009±\u200910\xa0years, mean infarct size 13.7\u2009±\u20097.1% of left ventricular mass', 'ST-segment elevation myocardial infarction']","['cardiovascular magnetic resonance (CMR', 'tagging with values obtained using novel cine-based software: Feature Tracking (FT) (TomTec, Germany) and Tissue Tracking (TT', 'circumferential strain and diastolic strain rate by CMR tagging, feature tracking and tissue tracking', 'TT']","['circumferential global peak-systolic strain (Ecc) and peak-early diastolic strain rate (PEDSR', 'repeatability of PEDSR', 'coefficients of variation (CoV) and intra-class correlation coefficient (ICC', 'Ecc and PEDSR']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}]","[{'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0037293', 'cui_str': 'Tag (morphologic abnormality)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0205113', 'cui_str': 'Circumferential (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}]","[{'cui': 'C0205113', 'cui_str': 'Circumferential (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic, function (observable entity)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C4077283', 'cui_str': '(67Ga)ECC'}]",20.0,0.0337012,Inter-study repeatability for Ecc at 1.5 T was good for tagging and excellent for FT and TT:,"[{'ForeName': 'Sheraz A', 'Initials': 'SA', 'LastName': 'Nazir', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health for Research (NIHR) Leicester Cardiovascular Biomedical Research Centre, Glenfield Hospital, Leicester, LE3 9QF, UK. sn191@le.ac.uk.'}, {'ForeName': 'Abhishek M', 'Initials': 'AM', 'LastName': 'Shetye', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health for Research (NIHR) Leicester Cardiovascular Biomedical Research Centre, Glenfield Hospital, Leicester, LE3 9QF, UK.'}, {'ForeName': 'Jamal N', 'Initials': 'JN', 'LastName': 'Khan', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health for Research (NIHR) Leicester Cardiovascular Biomedical Research Centre, Glenfield Hospital, Leicester, LE3 9QF, UK.'}, {'ForeName': 'Anvesha', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health for Research (NIHR) Leicester Cardiovascular Biomedical Research Centre, Glenfield Hospital, Leicester, LE3 9QF, UK.'}, {'ForeName': 'Jayanth R', 'Initials': 'JR', 'LastName': 'Arnold', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health for Research (NIHR) Leicester Cardiovascular Biomedical Research Centre, Glenfield Hospital, Leicester, LE3 9QF, UK.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Squire', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health for Research (NIHR) Leicester Cardiovascular Biomedical Research Centre, Glenfield Hospital, Leicester, LE3 9QF, UK.'}, {'ForeName': 'Gerry P', 'Initials': 'GP', 'LastName': 'McCann', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health for Research (NIHR) Leicester Cardiovascular Biomedical Research Centre, Glenfield Hospital, Leicester, LE3 9QF, UK.'}]",The international journal of cardiovascular imaging,['10.1007/s10554-020-01806-8']
819,30157976,Cost-effectiveness of PoNDER health visitor training for mothers at lower risk of depression: findings on prevention of postnatal depression from a cluster-randomised controlled trial.,"BACKGROUND


There is evidence for the cost-effectiveness of health visitor (HV) training to assess postnatal depression (PND) and deliver psychological approaches to women at risk of depression. Whether this approach is cost-effective for lower-risk women is unknown. There is a need to know the cost of HV-delivered universal provision, and how much it might cost to improve health-related quality of life for postnatal women. A sub-study of a cluster-randomised controlled trial in the former Trent region (England) previously investigated the effectiveness of PoNDER HV training in mothers at lower risk of PND. We conducted a parallel cost-effectiveness analysis at 6-months postnatal for all mothers with lower-risk status attributed to an Edinburgh Postnatal Depression Scale (EPDS) score &lt;12 at 6-weeks postnatal.
METHODS


Intervention HVs were trained in assessment and cognitive behavioural or person-centred psychological support techniques to prevent depression. Outcomes examined: quality-adjusted life-year (QALY) gains over the period between 6 weeks and 6 months derived from SF-6D (from SF-36); risk-of-depression at 6 months (dichotomising 6-month EPDS scores into lower risk (&lt;12) and at-risk (⩾12).
RESULTS


In lower-risk women, 1474 intervention (63 clusters) and 767 control participants (37 clusters) had valid 6-week and 6-month EPDS scores. Costs and outcomes data were available for 1459 participants. 6-month adjusted costs were £82 lower in intervention than control groups, with 0.002 additional QALY gained. The probability of cost-effectiveness at £20 000 was very high (99%).
CONCLUSIONS


PoNDER HV training was highly cost-effective in preventing symptoms of PND in a population of lower-risk women and cost-reducing over 6 months.",2019,"6-month adjusted costs were £82 lower in intervention than control groups, with 0.002 additional QALY gained.","['mothers with lower-risk status attributed to an Edinburgh Postnatal Depression Scale (EPDS) score &lt;12 at 6-weeks postnatal', 'mothers at lower risk of depression', 'women at risk of depression', 'mothers at lower risk of PND', '1459 participants']","['PoNDER health visitor training', 'PoNDER HV training', 'health visitor (HV) training', 'cognitive behavioural or person-centred psychological support techniques to prevent depression']","['6-month adjusted costs', 'quality-adjusted life-year (QALY) gains', 'probability of cost-effectiveness']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449234', 'cui_str': 'Attribute (attribute)'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score (observable entity)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C2976665', 'cui_str': 'P(TGTDI)Nd'}]","[{'cui': 'C0018765', 'cui_str': 'Health Visitors'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0600015', 'cui_str': 'Emotional support (regime/therapy)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.15181,"6-month adjusted costs were £82 lower in intervention than control groups, with 0.002 additional QALY gained.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Henderson', 'Affiliation': 'Personal Social Services Unit,London School of Economics and Political Science,London,UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Dixon', 'Affiliation': 'School of Health and Related Research, University of Sheffield,Sheffield,UK.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Bauer', 'Affiliation': 'Personal Social Services Unit,London School of Economics and Political Science,London,UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Knapp', 'Affiliation': 'Personal Social Services Unit,London School of Economics and Political Science,London,UK.'}, {'ForeName': 'C Jane', 'Initials': 'CJ', 'LastName': 'Morrell', 'Affiliation': 'School of Health Sciences, University of Nottingham,Nottingham,UK.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Slade', 'Affiliation': 'Institute of Psychology Health and Society, University of Liverpool,Liverpool,UK.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Walters', 'Affiliation': 'School of Health and Related Research, University of Sheffield,Sheffield,UK.'}, {'ForeName': 'Traolach', 'Initials': 'T', 'LastName': 'Brugha', 'Affiliation': 'Department of Health Sciences,University of Leicester,Leicester,UK.'}]",Psychological medicine,['10.1017/S0033291718001940']
820,32147329,Colour change of ceramic brackets with the use of coloured beverages in adolescent patients: A randomized clinical trial.,"OBJECTIVE


To clinically evaluate colour change of ceramic orthodontic brackets with the use of coloured beverages as ceramic brackets' resistance to discoloration has become a major concern.
MATERIAL AND METHODS


A prospective two parallel groups-split mouth randomized trial with a 1:1 allocation ratio. Two equal groups including 40 adolescent patients from the orthodontic department (Faculty of Dentistry, Mansoura University, Egypt), scheduled for maxillary premolar extractions were bonded with 2 types of mono-crystalline ceramic brackets: Type 1 (Inspire ICETM) and Type 2 (Radiance PlusTM). Participants in each group were asked to rinse with either black tea or Cola. After extraction, the colour of the 80 debonded brackets was compared to that of 20 control brackets from each type by spectrophotometer according to the international standard CIELAB colour space (CIE L*a*b*). The latter consists of three coordinates: L* (lightness value), a* and b* (the colour channels). The total colour difference ΔE* is the distance between two colours in this three-dimensional colour space. The colour change was also assessed by digital image analysis according to the RGB model.
RESULTS


Type 1 brackets showed mean ΔE* values of 2.24±0.25 in black tea and 1.76±0.1 in Cola groups (P<0.001), while Type 2 brackets showed means of 1.99±0.15 in black tea and 1.56±0.1 in Cola groups (P<0.001). The mean RGB values were 174.3±12.02 in black tea and 185.6±6.9 in the Cola groups of type 1 brackets (P<0.001), while were 166.5±17.8 in black tea and 190.8±8.9 in Cola groups of type 2 brackets (P<0.001).
CONCLUSION


Black tea showed more significant effect than Cola on the two bracket types. Bracket type affected the colour change in each beverage group.",2020,Bracket type affected the colour change in each beverage group.,"['40 adolescent patients from the orthodontic department (Faculty of Dentistry, Mansoura University, Egypt), scheduled for maxillary premolar extractions were bonded with 2 types of mono-crystalline ceramic brackets: Type 1 (Inspire ICETM) and Type 2 (Radiance PlusTM', 'adolescent patients']","['Black tea', 'rinse with either black tea or Cola']",['mean RGB values'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0587511', 'cui_str': 'Orthodontics department (environment)'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0013715', 'cui_str': 'Arab Republic of Egypt'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0007742', 'cui_str': 'Ceramics'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0452440', 'cui_str': 'Black Tea'}, {'cui': 'C0684195', 'cui_str': 'Cola'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",40.0,0.106843,Bracket type affected the colour change in each beverage group.,"[{'ForeName': 'Adnan M', 'Initials': 'AM', 'LastName': 'Shibani', 'Affiliation': 'Mansoura University, Faculty of Dentistry, Orthodontic Department, Mansoura, Egypt.'}, {'ForeName': 'Marwa Sameh', 'Initials': 'MS', 'LastName': 'Shamaa', 'Affiliation': 'Mansoura University, Faculty of Dentistry, Orthodontic Department, Mansoura, Egypt.'}, {'ForeName': 'Mona A', 'Initials': 'MA', 'LastName': 'Montasser', 'Affiliation': 'Mansoura University, Faculty of Dentistry, Orthodontic Department, Mansoura, Egypt. Electronic address: mmontasser11@yahoo.com.'}]",International orthodontics,['10.1016/j.ortho.2020.02.002']
821,31432434,"Effect of Anodal tDCS on Articulatory Accuracy, Word Production, and Syllable Repetition in Subjects with Aphasia: A Crossover, Double-Blinded, Sham-Controlled Trial.","INTRODUCTION


Transcranial direct-current stimulation (tDCS) has been used to modulate and induce changes in brain function and excitability. tDCS is a promising tool for the treatment of aphasia.
OBJECTIVE


To evaluate whether tDCS improves articulatory accuracy and speech production in patients with aphasia after stroke.
METHODS AND RESULTS


Twelve right-handed subjects participated in a double-blind, sham-controlled, crossover offline trial. We assessed (1) articulatory accuracy at a naming task, (2) number of words correctly produced, (3) number of syllables repeated correctly, and (4) qualitative assessment of speech. Articulatory accuracy improved when using tDCS over Broca's area in subjects with aphasia post-stroke (p ≤ 0.05). Qualitative improvement in the naming and syllable repetition tasks was observed, but the difference was not statistically significant (respectively, p = 0.15 and p = 0.79).
CONCLUSION


The current results corroborate the potential of tDCS to be used as an alternative and complementary treatment for individuals with aphasia.",2019,Articulatory accuracy improved when using tDCS over Broca's area in subjects with aphasia post-stroke (p ≤ 0.05).,"['Subjects with Aphasia', 'individuals with aphasia', 'patients with aphasia after stroke', 'Twelve right-handed subjects']","['tDCS', 'Transcranial direct-current stimulation (tDCS', 'Anodal tDCS']","['articulatory accuracy and speech production', 'Articulatory accuracy', 'Articulatory Accuracy, Word Production, and Syllable Repetition', 'articulatory accuracy at a naming task, (2) number of words correctly produced, (3) number of syllables repeated correctly, and (4) qualitative assessment of speech', 'naming and syllable repetition tasks']","[{'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0033268'}, {'cui': 'C4522128', 'cui_str': 'Name (property)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",12.0,0.18755,Articulatory accuracy improved when using tDCS over Broca's area in subjects with aphasia post-stroke (p ≤ 0.05).,"[{'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Vila-Nova', 'Affiliation': 'União Metropolitana de Educação e Cultura-UNIME, Kroton and University of the State of Bahia, Avenida Luis Tarquínio Pontes, 600, Lauro de Freitas, BA, Brazil. camivnova@gmail.com.'}, {'ForeName': 'Pedro H', 'Initials': 'PH', 'LastName': 'Lucena', 'Affiliation': 'Bahiana School of Medicine and Public Health, Av. Dom João VI, 275, Brotas, Salvador, BA, Brazil.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Lucena', 'Affiliation': 'School of Medicine of Bahia, Federal University of Bahia, Av. Luis Viana Filho S/N, Canela, Salvador, BA, Brazil.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Armani-Franceschi', 'Affiliation': 'Federal University of Bahia, Av. Luís Viana Filho S/N, Canela, Salvador, BA, Brazil.'}, {'ForeName': 'Fernanda Q', 'Initials': 'FQ', 'LastName': 'Campbell', 'Affiliation': 'The Heller School for Social Policy and Management, Brandeis University, 415 South Street, Waltham, MA, USA.'}]",Neurology and therapy,['10.1007/s40120-019-00149-4']
822,31857893,A study protocol for a randomised crossover study evaluating the effect of diets differing in carbohydrate quality on ileal content and appetite regulation in healthy humans.,"Introduction:  A major component of the digesta reaching the colon from the distal ileum is carbohydrate. This carbohydrate is subject to microbial fermentation and can radically change bacterial populations in the colon and the metabolites they produce, particularly short-chain fatty acids (SCFA). However, very little is currently known about the forms and levels of carbohydrate in the ileum and the composition of the ileal microbiota in humans. Most of our current understanding of carbohydrate that is not absorbed by the small intestine comes from ileostomy models, which may not reflect the physiology of an intact gastrointestinal tract.  Methods:  We will investigate how ileal content changes depending on diet using a randomised crossover study in healthy humans. Participants will be inpatients at the research facility for three separate 4-day visits. During each visit, participants will consume one of three diets, which differ in carbohydrate quality: 1) low-fibre refined diet; 2) high-fibre diet with intact cellular structures; 3) high-fibre diet where the cellular structures have been disrupted (e.g. milling, blending). On day 1, a nasoenteric tube will be placed into the distal ileum and its position confirmed under fluoroscopy. Ileal samples will be collected via the nasoenteric tube and metabolically profiled, which will determine the amount and type of carbohydrate present, and the composition of the ileal microbiota will be measured. Blood samples will be collected to assess circulating hormones and metabolites. Stool samples will be collected to assess faecal microbiota composition. Subjective appetite measures will be collected using visual analogue scales. Breath hydrogen will be measured in real-time as a marker of intestinal fermentation. Finally, an  in vitro  continuous fermentation model will be inoculated with ileal fluid in order to understand the shift in microbial composition and SCFA produced in the colon following the different diets.  Registration:  ISRCTN11327221.",2019,"During each visit, participants will consume one of three diets, which differ in carbohydrate quality: 1) low-fibre refined diet; 2) high-fibre diet with intact cellular structures; 3) high-fibre diet where the cellular structures have been disrupted (e.g. milling, blending).",['healthy humans'],['diets differing in carbohydrate quality'],"['faecal microbiota composition', 'Subjective appetite measures']","[{'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0406295,"During each visit, participants will consume one of three diets, which differ in carbohydrate quality: 1) low-fibre refined diet; 2) high-fibre diet with intact cellular structures; 3) high-fibre diet where the cellular structures have been disrupted (e.g. milling, blending).","[{'ForeName': 'Claire S', 'Initials': 'CS', 'LastName': 'Byrne', 'Affiliation': 'Section for Nutrition Research, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Blunt', 'Affiliation': 'Department of Imaging, Charing Cross Hospital, Imperial NHS Trust, London, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Burn', 'Affiliation': 'Department of Imaging, Charing Cross Hospital, Imperial NHS Trust, London, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Chambers', 'Affiliation': 'Section for Nutrition Research, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Aygul', 'Initials': 'A', 'LastName': 'Dagbasi', 'Affiliation': 'Section for Nutrition Research, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Franco Becker', 'Affiliation': 'Section for Nutrition Research, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Gibson', 'Affiliation': 'Department of Food and Nutritional Sciences, University of Reading, Reading, UK.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Mendoza', 'Affiliation': 'Section for Nutrition Research, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Murphy', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Poveda', 'Affiliation': 'Department of Food and Nutritional Sciences, University of Reading, Reading, UK.'}, {'ForeName': 'Anya', 'Initials': 'A', 'LastName': 'Ramgulam', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Tashkova', 'Affiliation': 'Section for Nutrition Research, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Walton', 'Affiliation': 'Department of Food and Nutritional Sciences, University of Reading, Reading, UK.'}, {'ForeName': 'Chaiwat', 'Initials': 'C', 'LastName': 'Washirasaksiri', 'Affiliation': 'Section for Nutrition Research, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Frost', 'Affiliation': 'Section for Nutrition Research, Department of Medicine, Imperial College London, London, UK.'}]",F1000Research,['10.12688/f1000research.17870.2']
823,31745072,High-dose eicosapentaenoic acid (EPA) improves attention and vigilance in children and adolescents with attention deficit hyperactivity disorder (ADHD) and low endogenous EPA levels.,"No studies have examined the relationship between endogenous polyunsaturated fatty acids (PUFAs) levels and treatment response to PUFAs. We conducted a 12-week, double-blind, placebo-controlled trial comparing the effects of high-dose eicosapentaenoic acid (EPA, 1.2 g) and placebo on cognitive function (continuous performance test) in n = 92 youth (age 6-18-years-old) with Attention Deficit Hyperactivity Disorder (ADHD). Blood erythrocytes PUFAs were measured before and after treatment, to examine the effects of baseline endogenous EPA levels on treatment response and the effects of EPA treatment on PUFAs levels. Secondary measures included other ADHD symptoms, emotional symptoms, and levels of plasma high-sensitivity c-reactive protein (hs-CRP) and brain-derived neurotrophic factor (BDNF). Overall, EPA group improved more than placebo group on focused attention (variability, Effect size (ES) = 0.38, p = 0.041); moreover, within youth with the lowest baseline endogenous EPA levels, EPA group improved more than placebo group in another measure of focused attention (hit reaction time, HRT, ES = 0.89, p = 0.015) and in vigilance (HRT interstimulus interval changes, HRTISIC, ES = 0.83, p = 0.036). Interestingly, EPA group improved less than placebo group in impulsivity (commission errors), both overall and in youth with the highest baseline EPA levels, who also showed less improvement in other ADHD and emotional symptoms. EPA increased blood erythrocytes EPA by 1.6-fold but not DHA levels, and did not affect hs-CRP and BDNF plasma levels. In conclusion, EPA treatment improves cognitive symptoms in ADHD youth, especially if they have a low baseline endogenous EPA level, while youth with high EPA levels may be negatively affected by this treatment.",2019,"EPA increased blood erythrocytes EPA by 1.6-fold but not DHA levels, and did not affect hs-CRP and BDNF plasma levels.","['children and adolescents with attention deficit hyperactivity disorder (ADHD', 'n\u2009=\u200992 youth (age 6-18-years-old) with Attention Deficit Hyperactivity Disorder (ADHD']","['placebo', 'eicosapentaenoic acid (EPA', 'high-dose eicosapentaenoic acid (EPA, 1.2\u2009g) and placebo', 'EPA']","['blood erythrocytes EPA', 'endogenous polyunsaturated fatty acids (PUFAs) levels', 'ADHD and emotional symptoms', 'cognitive symptoms', 'Blood erythrocytes PUFAs', 'impulsivity (commission errors', 'hs-CRP and BDNF plasma levels', 'vigilance (HRT interstimulus interval changes', 'cognitive function (continuous performance test', 'PUFAs levels', 'ADHD symptoms, emotional symptoms, and levels of plasma high-sensitivity c-reactive protein (hs-CRP) and brain-derived neurotrophic factor (BDNF']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4068880', 'cui_str': 'One point two'}]","[{'cui': 'C0005768'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0525041', 'cui_str': 'Cognitive Symptoms'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy (procedure)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",92.0,0.570182,"EPA increased blood erythrocytes EPA by 1.6-fold but not DHA levels, and did not affect hs-CRP and BDNF plasma levels.","[{'ForeName': 'Jane Pei-Chen', 'Initials': 'JP', 'LastName': 'Chang', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, WC2R 2LS, UK.""}, {'ForeName': 'Kuan-Pin', 'Initials': 'KP', 'LastName': 'Su', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, WC2R 2LS, UK. cobolsu@gmail.com.""}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Mondelli', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, WC2R 2LS, UK.""}, {'ForeName': 'Senthil Kumaran', 'Initials': 'SK', 'LastName': 'Satyanarayanan', 'Affiliation': 'Department of Psychiatry, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Hui-Ting', 'Initials': 'HT', 'LastName': 'Yang', 'Affiliation': 'College of Nutrition, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yi-Ju', 'Initials': 'YJ', 'LastName': 'Chiang', 'Affiliation': 'Department of Psychiatry, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Hui-Ting', 'Initials': 'HT', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Carmine M', 'Initials': 'CM', 'LastName': 'Pariante', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, WC2R 2LS, UK.""}]",Translational psychiatry,['10.1038/s41398-019-0633-0']
824,31709970,"Glycaemic, gastrointestinal, hormonal and appetitive responses to pearl millet or oats porridge breakfasts: a randomised, crossover trial in healthy humans.","Whole-grain cereal breakfast consumption has been associated with beneficial effects on glucose and insulin metabolism as well as satiety. Pearl millet is a popular ancient grain variety that can be grown in hot, dry regions. However, little is known about its health effects. The present study investigated the effect of a pearl millet porridge (PMP) compared with a well-known Scottish oats porridge (SOP) on glycaemic, gastrointestinal, hormonal and appetitive responses. In a randomised, two-way crossover trial, twenty-six healthy participants consumed two isoenergetic/isovolumetric PMP or SOP breakfast meals, served with a drink of water. Blood samples for glucose, insulin, glucagon-like peptide 1, glucose-dependent insulinotropic polypeptide (GIP), peptide YY, gastric volumes and appetite ratings were collected 2 h postprandially, followed by an ad libitum meal and food intake records for the remainder of the day. The incremental AUC (iAUC2h) for blood glucose was not significantly different between the porridges (P > 0·05). The iAUC2h for gastric volume was larger for PMP compared with SOP (P = 0·045). The iAUC2h for GIP concentration was significantly lower for PMP compared with SOP (P = 0·001). Other hormones and appetite responses were similar between meals. In conclusion, the present study reports, for the first time, data on glycaemic and physiological responses to a pearl millet breakfast, showing that this ancient grain could represent a sustainable alternative with health-promoting characteristics comparable with oats. GIP is an incretin hormone linked to TAG absorption in adipose tissue; therefore, the lower GIP response for PMP may be an added health benefit.",2019,The iAUC2h for gastric volume was larger for PMP compared with SOP (P = 0·045).,"['twenty-six healthy participants consumed two isoenergetic/isovolumetric PMP or SOP breakfast meals, served with a drink of water', 'healthy humans']","['pearl millet porridge (PMP', 'pearl millet or oats porridge breakfasts', 'well-known Scottish oats porridge (SOP']","['GIP concentration', 'Blood samples for glucose, insulin, glucagon-like peptide 1, glucose-dependent insulinotropic polypeptide (GIP), peptide YY, gastric volumes and appetite ratings', 'glycaemic, gastrointestinal, hormonal and appetitive responses', 'incremental AUC (iAUC2h) for blood glucose', 'Glycaemic, gastrointestinal, hormonal and appetitive responses']","[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0331550', 'cui_str': 'Millet, Pearl'}, {'cui': 'C0452575', 'cui_str': 'Porridge (substance)'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}]","[{'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1305923', 'cui_str': 'Polypeptides'}, {'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",26.0,0.111805,The iAUC2h for gastric volume was larger for PMP compared with SOP (P = 0·045).,"[{'ForeName': 'Jaber', 'Initials': 'J', 'LastName': 'Alyami', 'Affiliation': 'Department of Diagnostic Radiology, Faculty of Applied Medical Science, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Whitehouse', 'Affiliation': 'Nottingham Digestive Diseases Centre, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Gleb E', 'Initials': 'GE', 'LastName': 'Yakubov', 'Affiliation': 'Division of Food, Nutrition and Dietetics, School of Biosciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Pritchard', 'Affiliation': 'Sir Peter Mansfield Imaging Centre, School of Physics and Astronomy, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Caroline L', 'Initials': 'CL', 'LastName': 'Hoad', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Blackshaw', 'Affiliation': 'Medical Physics and Clinical Engineering, Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Heissam', 'Affiliation': 'Nottingham Digestive Diseases Centre, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Sally M', 'Initials': 'SM', 'LastName': 'Cordon', 'Affiliation': 'School of Life Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'H Frances J', 'Initials': 'HFJ', 'LastName': 'Bligh', 'Affiliation': 'Unilever R&D, Colworth Science Park, Sharnbrook, Bedfordshire, UK.'}, {'ForeName': 'Robin C', 'Initials': 'RC', 'LastName': 'Spiller', 'Affiliation': 'Nottingham Digestive Diseases Centre, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Macdonald', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Guruprasad P', 'Initials': 'GP', 'LastName': 'Aithal', 'Affiliation': 'Nottingham Digestive Diseases Centre, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Penny A', 'Initials': 'PA', 'LastName': 'Gowland', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Moira A', 'Initials': 'MA', 'LastName': 'Taylor', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Marciani', 'Affiliation': 'Nottingham Digestive Diseases Centre, School of Medicine, University of Nottingham, Nottingham, UK.'}]",The British journal of nutrition,['10.1017/S0007114519001880']
825,30511292,A School-Based Program to Promote Well-Being in Preadolescents: Results From a Cluster Quasi-Experimental Controlled Study.,"Diario della Salute [My Health Diary] is a school-based program designed to enhance the subjective well-being and health of 12- to 13-year-old students. We hypothesized that providing students with the social and emotional skills to fulfill their potential and deal with common developmental tasks of adolescence (e.g., onset of puberty, identity development, increased responsibilities and academic demands) would result in improved well-being and health. The program comprises five standardized interactive lessons concerning common psychosocial and health issues in adolescence, and two narrative booklets addressed to both students and their parents. We evaluated the effectiveness of the program in terms of the students' subjective well-being, aggressive behavior, and health behavior. Using a quasi-experimental study design, schools in the intervention group implemented the full program and those in the comparison group received their regular curriculum. We administered measures of the study's objectives both before and after program implementation. Statistical analyses accounted for within-school clustering, potential socioeconomic and demographic confounding, and pre-implementation levels of these measures. We sampled 62 schools and allocated 2630 students to either an intervention or comparison group. Sociodemographic characteristics and baseline outcomes were balanced across study groups. Unexpectedly, respondents in the intervention group had 0.38 greater mean adjusted score of the WHO/Europe Health Behaviour in School-Aged Children Symptom Checklist instrument than respondents in the comparison group, indicating a reduction in subjective well-being. We did not observe any program effects on aggressive and health behaviors. The apparent reduction in subjective well-being reflected by an increased perception of psychosomatic complaints is suggestive of either increased emotional competence or, potentially, iatrogenic program effects. While greater emotional competence is positively associated with well-being over the course of life, the program in its present form should not be disseminated due to the possibility of adverse unintended effects.",2019,"Unexpectedly, respondents in the intervention group had 0.38 greater mean adjusted score of the WHO/Europe Health Behaviour in School-Aged Children Symptom Checklist instrument than respondents in the comparison group, indicating a reduction in subjective well-being.","['Preadolescents', '62 schools and allocated 2630 students to either an intervention or comparison group']",['Diario della Salute [My Health Diary'],"['mean adjusted score of the WHO/Europe Health Behaviour', 'aggressive and health behaviors', 'emotional competence']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0018700', 'cui_str': 'Health Diaries'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018687'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",,0.0150131,"Unexpectedly, respondents in the intervention group had 0.38 greater mean adjusted score of the WHO/Europe Health Behaviour in School-Aged Children Symptom Checklist instrument than respondents in the comparison group, indicating a reduction in subjective well-being.","[{'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Allara', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK. elias.allara@med.uniupo.it.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Beccaria', 'Affiliation': 'Eclectica Institute of Research, Training and Communication, Turin, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Molinar', 'Affiliation': 'Department of Translational Medicine, Università del Piemonte Orientale, Via Solaroli 17, Novara, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Marinaro', 'Affiliation': 'Epidemiology Unit, Prevention Department, CN2 Local Health Authority, Alba, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Ermacora', 'Affiliation': 'Eclectica Institute of Research, Training and Communication, Turin, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Coppo', 'Affiliation': 'Department of Translational Medicine, Università del Piemonte Orientale, Via Solaroli 17, Novara, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Faggiano', 'Affiliation': 'Department of Translational Medicine, Università del Piemonte Orientale, Via Solaroli 17, Novara, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of primary prevention,['10.1007/s10935-018-0530-y']
826,31482848,The Use of and Experiences With Telelactation Among Rural Breastfeeding Mothers: Secondary Analysis of a Randomized Controlled Trial.,"BACKGROUND


Telelactation services connect breastfeeding mothers to remotely located lactation consultants through audio-visual technology and can increase access to professional breastfeeding support in rural areas.
OBJECTIVE


The objective of this study was to identify maternal characteristics associated with the demand for and use of telelactation and to describe visit characteristics.
METHODS


We conducted a descriptive study within the context of a randomized controlled trial. Participant survey data and vendor electronic medical record data were used to assess video call characteristics like timing, duration, topics discussed, and participant satisfaction. Recruitment occurred from 2016-2018 at a rural critical access hospital in Pennsylvania. The 102 women enrolled in the study were given access to unlimited, on-demand video calls with lactation consultants through a mobile phone app and were tracked for 12 weeks following their postpartum hospitalization.
RESULTS


A total of 94 participants out of 102 recruits (92%) participated in the final, 12-week survey assessment were included in the analysis. Of those, 47 (50%) participants reported participating in one or more video calls, and 31 (33%) completed one or more calls that included a substantive discussion of a breastfeeding challenge. Participants who used telelactation (21/31, 68%; P=.02) were more likely to be working at 12 weeks postpartum compared to others (26/63, 41%), were less likely (12/31, 39%; P=.02) to have prior breastfeeding experience on average compared to nonusers (41/63, 65%), and were less likely to have breastfed exclusively (16/31, 52%; P<.001) prior to hospital discharge compared to mothers who didn't use telelactation services (51/63, 81%). Most video calls (58/83, 70%) occurred during the infant's first month of life and 41% (34/83) occurred outside of business hours. The most common challenges discussed included: breast pain, soreness, and infection (25/83, 30%), use of nipple shields (21/83, 25%), and latch or positioning (17/83, 24%). Most telelactation users (43/47, 91%) expressed satisfaction with the help received.
CONCLUSIONS


Telelactation is an innovation in the delivery of professional breastfeeding support. This research documents both demand for and positive experiences with telelactation in an underserved population.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02870413; https://clinicaltrials.gov/ct2/show/NCT02870413.",2019,"Participants who used telelactation (21/31, 68%; P=.02) were more likely to be working at 12 weeks postpartum compared to others (26/63, 41%), were less likely (12/31, 39%; P=.02) to have prior breastfeeding experience on average compared to nonusers (41/63, 65%), and were less likely to have breastfed exclusively (16/31, 52%; P<.001) prior to hospital discharge compared to mothers who didn't use telelactation services (51/63, 81%).","['102 women enrolled in the study were given access to unlimited, on-demand video calls with lactation consultants through a mobile phone app and were tracked for 12 weeks following their postpartum hospitalization', 'Rural Breastfeeding Mothers', '94 participants out of 102 recruits (92%) participated in the final, 12-week survey assessment were included in the analysis']",[],"['hospital discharge', 'breast pain, soreness, and infection']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0558270', 'cui_str': 'Lactation consultant (occupation)'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",[],"[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0024902', 'cui_str': 'Mammalgia'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",94.0,0.184576,"Participants who used telelactation (21/31, 68%; P=.02) were more likely to be working at 12 weeks postpartum compared to others (26/63, 41%), were less likely (12/31, 39%; P=.02) to have prior breastfeeding experience on average compared to nonusers (41/63, 65%), and were less likely to have breastfed exclusively (16/31, 52%; P<.001) prior to hospital discharge compared to mothers who didn't use telelactation services (51/63, 81%).","[{'ForeName': 'Kandice', 'Initials': 'K', 'LastName': 'Kapinos', 'Affiliation': 'RAND Corporation, Arlington, VA, United States.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Kotzias', 'Affiliation': 'RAND Corporation, Arlington, VA, United States.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Bogen', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, United States.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Ray', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, United States.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Demirci', 'Affiliation': 'University of Pittsburgh School of Nursing, Pittsburgh, PA, United States.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Rigas', 'Affiliation': 'UPMC Cole Hospital, Coudersport, PA, United States.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Uscher-Pines', 'Affiliation': 'RAND Corporation, Arlington, VA, United States.'}]",Journal of medical Internet research,['10.2196/13967']
827,31823314,Translating CKD Research into Primary Care Practice: a Group-Randomized Study.,"BACKGROUND


Chronic kidney disease (CKD) is common in the primary care setting. Early interventions may prevent progression of renal disease and reduce risk for cardiovascular complications, yet quality gaps have been documented. Successful approaches to improve identification and management of CKD in primary care are needed.
OBJECTIVE


To assess whether implementation of a primary care improvement model results in improved identification and management of CKD DESIGN: 18-month group-randomized study PARTICIPANTS: 21 primary care practices in 13 US states caring for 107,094 patients INTERVENTIONS: To promote implementation of CKD improvement strategies, intervention practices received clinical quality measure (CQM) reports at least quarterly, hosted an on-site visit and 2 webinars, and sent clinician/staff representatives to a ""best practice"" meeting. Control practices received CQM reports at least quarterly.
MAIN MEASURES


Changes in practice adherence to a set of 11 CKD CQMs KEY RESULTS: We observed significantly greater improvements among intervention practices for annual screening for albuminuria in patients with diabetes or hypertension (absolute change 22% in the intervention group vs. - 2.6% in the control group, p < 0.0001) and annual monitoring for albuminuria in patients with CKD (absolute change 21% in the intervention group vs. - 2.0% in the control group, p < 0.0001). Avoidance of NSAIDs in patients with CKD declined in both intervention and control groups, with a significantly greater decline in the control practices (absolute change - 5.0% in the intervention group vs. - 10% in the control group, p < 0.0001). There were no other significant changes found for the other CQMs. Variable implementation of CKD improvement strategies was noted across the intervention practices.
CONCLUSIONS


Implementation of a primary care improvement model designed to improve CKD identification and management resulted in significantly improved care on 3 out of 11 CQMs. Incomplete adoption of improvement strategies may have limited further improvement. Improving CKD identification and management likely requires a longer and more intensive intervention.",2020,"Avoidance of NSAIDs in patients with CKD declined in both intervention and control groups, with a significantly greater decline in the control practices (absolute change - 5.0% in the intervention group vs. - 10% in the control group, p < 0.0001).","['Chronic kidney disease (CKD', ' 21 primary care practices in 13 US states caring for 107,094 patients', 'patients with CKD']",[],"['annual monitoring for albuminuria', 'control practices']","[{'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.0267615,"Avoidance of NSAIDs in patients with CKD declined in both intervention and control groups, with a significantly greater decline in the control practices (absolute change - 5.0% in the intervention group vs. - 10% in the control group, p < 0.0001).","[{'ForeName': 'Cara B', 'Initials': 'CB', 'LastName': 'Litvin', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA. litvincb@musc.edu.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Nietert', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Ruth G', 'Initials': 'RG', 'LastName': 'Jenkins', 'Affiliation': 'Department of Family Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Wessell', 'Affiliation': 'Department of Family Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Lynne S', 'Initials': 'LS', 'LastName': 'Nemeth', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Ornstein', 'Affiliation': 'Department of Family Medicine, Medical University of South Carolina, Charleston, SC, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05353-4']
828,31425580,"TAILoR (TelmisArtan and InsuLin Resistance in Human Immunodeficiency Virus [HIV]): An Adaptive-design, Dose-ranging Phase IIb Randomized Trial of Telmisartan for the Reduction of Insulin Resistance in HIV-positive Individuals on Combination Antiretroviral Therapy.","BACKGROUND


Combination antiretroviral therapy results in metabolic abnormalities which increase cardiovascular disease risk. We evaluated whether telmisartan reduces insulin resistance in human immunodeficiency virus (HIV)-positive individuals on antiretrovirals.
METHODS


We conducted a multicenter, randomized, open-label, dose-ranging controlled trial of telmisartan. Participants with HIV infection receiving combination antiretroviral therapy were randomized equally to either no intervention (control) or 20, 40, or 80 mg telmisartan once daily. The adaptive design allowed testing of all dose(s) of telmisartan in stage I, with the promising dose(s) being taken into stage II. The primary outcome measure was reduction in homeostasis model assessment of insulin resistance (HOMA-IR) at 24 weeks.
RESULTS


A total of 377 patients were recruited. In stage I, 48, 49, 47, and 45 patients were randomized to control and 20, 40, and 80 mg telmisartan, respectively (total n = 189). At the interim analysis, 80 mg telmisartan was taken forward into stage II. At the end of stage II (n = 105, control; 106, 80-mg arm), there were no differences in HOMA-IR (estimated effect, 0.007; SE, 0.106) at 24 weeks between the telmisartan (80 mg) and nonintervention arms. Longitudinal analysis over 48 weeks showed no change in HOMA-IR, lipid or adipokine levels. There were significant (P ≤ .05), but marginal, improvements in revised Quantitative Insulin Sensitivity Check Index (QUICKI) (0.004) and plasma hs-CRP (-0.222 mg/L) and reduction in liver fat content (1.714 mean reduction; P = .005).
CONCLUSIONS


No significant effect of telmisartan was demonstrated on the primary outcome (HOMA-IR), but there were marginal improvements with some secondary outcome measures. Further studies in this population are warranted to identify novel strategies for preventing cardiovascular morbidity and mortality.
CLINICAL TRIAL REGISTRATION


ISRCTN registry (51069819).",2020,"There were significant (P ≤ .05), but marginal, improvements in revised Quantitative Insulin Sensitivity Check Index (QUICKI) (0.004) and plasma hs-CRP (-0.222 mg/L) and reduction in liver fat content (1.714 mean reduction; P = .005).
","['Human Immunodeficiency Virus [HIV', 'In stage I, 48, 49, 47, and 45 patients', 'Participants with HIV infection receiving combination antiretroviral therapy', 'A total of 377 patients were recruited', 'human immunodeficiency virus (HIV)-positive individuals on antiretrovirals', 'HIV-positive Individuals on Combination Antiretroviral Therapy']","['Telmisartan', 'telmisartan', 'TAILoR', 'no intervention (control) or 20, 40, or 80 mg telmisartan', 'TelmisArtan and InsuLin Resistance']","['primary outcome (HOMA-IR', 'HOMA-IR', 'HOMA-IR, lipid or adipokine levels', 'reduction in homeostasis model assessment of insulin resistance (HOMA-IR', 'insulin resistance', 'revised Quantitative Insulin Sensitivity Check Index (QUICKI) (0.004) and plasma hs-CRP', 'liver fat content']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}]","[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1955907', 'cui_str': 'Adipocytokines'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",377.0,0.260865,"There were significant (P ≤ .05), but marginal, improvements in revised Quantitative Insulin Sensitivity Check Index (QUICKI) (0.004) and plasma hs-CRP (-0.222 mg/L) and reduction in liver fat content (1.714 mean reduction; P = .005).
","[{'ForeName': 'Sudeep', 'Initials': 'S', 'LastName': 'Pushpakom', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, University of Liverpool, United Kingdom.'}, {'ForeName': 'Ruwanthi', 'Initials': 'R', 'LastName': 'Kolamunnage-Dona', 'Affiliation': 'Department of Biostatistics, University of Liverpool, United Kingdom.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, United Kingdom.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Foster', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, University of Liverpool, United Kingdom.'}, {'ForeName': 'Cath', 'Initials': 'C', 'LastName': 'Spowart', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, United Kingdom.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'García-Fiñana', 'Affiliation': 'Department of Biostatistics, University of Liverpool, United Kingdom.'}, {'ForeName': 'Graham J', 'Initials': 'GJ', 'LastName': 'Kemp', 'Affiliation': 'Liverpool Magnetic Resonance Imaging Centre, University of Liverpool, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': 'Department of Mathematics and Statistics, Lancaster University, United Kingdom.'}, {'ForeName': 'Saye', 'Initials': 'S', 'LastName': 'Khoo', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, University of Liverpool, United Kingdom.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Williamson', 'Affiliation': 'Department of Biostatistics, University of Liverpool, United Kingdom.'}, {'ForeName': 'Munir', 'Initials': 'M', 'LastName': 'Pirmohamed', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, University of Liverpool, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz589']
829,31654272,Efficacy and Safety of Alemtuzumab in Patients of African Descent with Relapsing-Remitting Multiple Sclerosis: 8-Year Follow-up of CARE-MS I and II (TOPAZ Study).,"INTRODUCTION


Multiple sclerosis (MS) patients of African descent have increased risk for disease progression and may be less responsive to disease-modifying therapy.
METHODS


Patients in the CARE-MS studies received alemtuzumab 12 mg/day [initial alemtuzumab treatment (IAT); baseline: 5 days; 12 months later: 3 days] or subcutaneous interferon beta-1a (SC IFNB-1a) 3 ×/week. Core study outcomes were compared between treatment groups. In the extension study CAMMS03409, SC IFNB-1a-treated patients switched to alemtuzumab [delayed alemtuzumab treatment (DAT)]. Data from IAT and DAT arms were pooled to assess outcomes through 6 years post alemtuzumab initiation; IAT patients had an additional 2 years of follow-up in TOPAZ.
RESULTS


Of 1200 CARE-MS patients, 43 (4%) were of African descent (35 IAT; 8 DAT) and received alemtuzumab in the 2-year core and/or 6-year extension; 29 (67%) remained on study at the time of analysis (24 IAT patients completed year 8 post alemtuzumab; 5 DAT patients completed year 6 post alemtuzumab). In year 2, annualized relapse rate (ARR; 0.09 versus 0.42), percentage of patients with improved Expanded Disability Status Scale (EDSS; 18% versus 11%), 6-month confirmed disability improvement (CDI; 28% versus 13%), no evidence of disease activity (55% versus 13%), and cumulative brain volume loss (BVL; - 0.55% versus - 1.32%) favored alemtuzumab versus SC IFNB-1a. Alemtuzumab remained efficacious at year 6 (pooled IAT/DAT) and at year 8 (IAT only) post alemtuzumab (ARR: 0.15 and 0.30; improved EDSS: 17% and 25%; CDI: 47% and 55%; BVL: - 1.14% and - 0.70%, respectively). No safety signals were unique to this population.
CONCLUSIONS


Alemtuzumab was efficacious in a small cohort of relapsing-remitting MS patients of African descent over 8 years. Safety was consistent with the overall CARE-MS population, although the small sample size may have prevented the detection of known low-frequency adverse events. CLINICALTRIALS.
GOV REGISTRATION NUMBERS


CARE-MS I, II, extension, TOPAZ: NCT00530348, NCT00548405, NCT00930553, NCT02255656.
FUNDING


Sanofi (Cambridge, MA, USA) and Bayer HealthCare Pharmaceuticals (Leverkusen, Germany).",2019,"In year 2, annualized relapse rate (ARR; 0.09 versus 0.42), percentage of patients with improved Expanded Disability Status Scale (EDSS; 18% versus 11%), 6-month confirmed disability improvement (CDI; 28% versus 13%), no evidence of disease activity (55% versus 13%), and cumulative brain volume loss (BVL; - 0.55% versus - 1.32%) favored alemtuzumab versus SC IFNB-1a.","['Patients of African Descent with Relapsing-Remitting Multiple Sclerosis', 'Patients in the CARE-MS studies received']","['alemtuzumab', 'alemtuzumab 12\xa0mg/day [initial alemtuzumab treatment (IAT); baseline: 5\xa0days; 12\xa0months later: 3\xa0days] or subcutaneous interferon beta-1a (SC IFNB-1a', 'TOPAZ', 'Alemtuzumab', 'alemtuzumab [delayed alemtuzumab treatment (DAT']","['Efficacy and Safety', 'disease activity', 'EDSS', 'Expanded Disability Status Scale', '6-month confirmed disability improvement', 'annualized relapse rate', 'cumulative brain volume loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751967', 'cui_str': 'Multiple Sclerosis, Relapsing-Remitting'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0383429', 'cui_str': 'alemtuzumab'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0254119', 'cui_str': 'Interferon beta-1a'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",1200.0,0.0589401,"In year 2, annualized relapse rate (ARR; 0.09 versus 0.42), percentage of patients with improved Expanded Disability Status Scale (EDSS; 18% versus 11%), 6-month confirmed disability improvement (CDI; 28% versus 13%), no evidence of disease activity (55% versus 13%), and cumulative brain volume loss (BVL; - 0.55% versus - 1.32%) favored alemtuzumab versus SC IFNB-1a.","[{'ForeName': 'Annette F', 'Initials': 'AF', 'LastName': 'Okai', 'Affiliation': 'Multiple Sclerosis Treatment Center of Dallas, Dallas, TX, USA. afokai@gmail.com.'}, {'ForeName': 'Lilyana', 'Initials': 'L', 'LastName': 'Amezcua', 'Affiliation': 'Keck School of Medicine of University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Regina R', 'Initials': 'RR', 'LastName': 'Berkovich', 'Affiliation': 'Keck School of Medicine of University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Angel R', 'Initials': 'AR', 'LastName': 'Chinea', 'Affiliation': 'San Juan Multiple Sclerosis Center, Guaynabo, PR, USA.'}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Edwards', 'Affiliation': 'MS Center of Northeastern New York, Latham, NY, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Steingo', 'Affiliation': 'Fort Lauderdale Multiple Sclerosis Center, Fort Lauderdale, FL, USA.'}, {'ForeName': 'Aljoeson', 'Initials': 'A', 'LastName': 'Walker', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Alan K', 'Initials': 'AK', 'LastName': 'Jacobs', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Daizadeh', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Mitzi J', 'Initials': 'MJ', 'LastName': 'Williams', 'Affiliation': 'Multiple Sclerosis Center of Atlanta, Mableton, GA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology and therapy,['10.1007/s40120-019-00159-2']
830,31242065,"Mechanisms and perceived mental health changes after a livelihood intervention for HIV-positive Kenyans: Longitudinal, qualitative findings.","While food insecurity and poverty worsen mental health outcomes among people living with HIV/AIDS (PLHIV), few intervention studies have targeted poverty and food insecurity as a way to improve mental health. Among HIV-positive patients, addressing such upstream determinants may prove crucial to ensure better mental health and HIV clinical outcomes. We integrated longitudinal, qualitative research into a randomized trial of a livelihood intervention to understand processes and mechanisms for how the intervention may affect mental health among HIV-infected Kenyan adults. In-depth interviews were conducted with intervention participants ( n  = 45) and control participants ( n  = 9) at two time-points (after intervention start and upon intervention end). Interviews ( n  = 85) were translated, double-coded, and analyzed thematically using an inductive-deductive team approach. Participants reported numerous mental health improvements post-intervention including reduced stress, fewer symptoms of anxiety, improved mood, lower depressive symptoms, fewer repetitive and ruminating thoughts, and more hopefulness for the future. Improvements in mental health appear to occur via several mechanisms including: 1) better food security and income; 2) increased physical activity and ability to create fruitful routines around farm work; and, 3) improved sense of self as an active member of the community. Qualitative, longitudinal interviews may help identify intervention mechanisms for improved mental health, but additional research is required to confirm self-reports of mental health changes. These findings suggest that livelihood interventions may improve mental health in multi-faceted ways, and help PLHIV better integrate with their communities.  Trial registered  at ClinicalTrials.gov: NCT01548599.",2020,"Participants reported numerous mental health improvements post-intervention including reduced stress, fewer symptoms of anxiety, improved mood, lower depressive symptoms, fewer repetitive and ruminating thoughts, and more hopefulness for the future.","['people living with HIV/AIDS (PLHIV', 'HIV-infected Kenyan adults', 'Interviews ( n \u2009']","['livelihood interventions', 'livelihood intervention']","['physical activity and ability to create fruitful routines around farm work; and, 3) improved sense of self', 'mental health', 'reduced stress, fewer symptoms of anxiety, improved mood, lower depressive symptoms, fewer repetitive and ruminating thoughts']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0337839', 'cui_str': 'Kenyans (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0557759', 'cui_str': 'Farmland'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C4319827', 'cui_str': 'Thought'}]",85.0,0.122443,"Participants reported numerous mental health improvements post-intervention including reduced stress, fewer symptoms of anxiety, improved mood, lower depressive symptoms, fewer repetitive and ruminating thoughts, and more hopefulness for the future.","[{'ForeName': 'Abigail M', 'Initials': 'AM', 'LastName': 'Hatcher', 'Affiliation': 'University of California and University of the Witwatersrand.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Lemus Hufstedler', 'Affiliation': 'University of California.'}, {'ForeName': 'Kathryne', 'Initials': 'K', 'LastName': 'Doria', 'Affiliation': 'Yale University.'}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Dworkin', 'Affiliation': 'University of Washington.'}, {'ForeName': 'Elly', 'Initials': 'E', 'LastName': 'Weke', 'Affiliation': 'Kenya Medical Research Institute.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Conroy', 'Affiliation': 'University of California.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'Kenya Medical Research Institute and University of Washington.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Cohen', 'Affiliation': 'University of California.'}, {'ForeName': 'Sheri D', 'Initials': 'SD', 'LastName': 'Weiser', 'Affiliation': 'University of California.'}]",Transcultural psychiatry,['10.1177/1363461519858446']
831,31678769,Overestimated treatment effects in randomised phase II trials: What's up doctor?,,2019,,[],[],[],[],[],[],,0.0191432,,"[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Michiels', 'Affiliation': ""Service de Biostatistique et D'Épidémiologie, Gustave Roussy, Université Paris-Saclay, 94805 Villejuif, France; CESP INSERM U1018, Université Paris-Sud, Université Paris-Saclay, 94805 Villejuif, France. Electronic address: stefan.michiels@gustaveroussy.fr.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wason', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle Upon Tyne, UK; MRC Biostatistics Unit, University of Cambridge, Cambridge, UK.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.09.023']
832,31791405,"Improving risk perception and uptake of pre-exposure prophylaxis (PrEP) through interactive feedback-based counselling with and without community engagement in young women in Manicaland, East Zimbabwe: study protocol for a pilot randomized trial.","BACKGROUND


HIV incidence in adolescent girls and young women remains high in sub-Saharan Africa. Progress towards uptake of HIV prevention methods remains low. Studies of oral pre-exposure prophylaxis (PrEP) have shown that uptake and adherence may be low due to low-risk perception and ambivalence around using antiretrovirals for prevention. No evidence exists on whether an interactive intervention aimed at adjusting risk perception and addressing the uncertainty around PrEP will improve uptake. This pilot research trial aims to provide an initial evaluation of the impact of an interactive digital tablet-based counselling session, correcting risk perception, and addressing ambiguity around availability, usability, and effectiveness of PrEP.
METHODS/DESIGN


This is a matched-cluster randomized controlled trial which will compare an interactive tablet-based education intervention against a control with no intervention. The study will be implemented in eight sites. In each site, two matched clusters of villages will be created. One cluster will be randomly allocated to intervention. In two sites, a community engagement intervention will also be implemented to address social obstacles and to increase support from peers, families, and social structures. A total of 1200 HIV-negative young women aged 18-24 years, not on PrEP at baseline, will be eligible. Baseline measures of endpoints will be gathered in surveys. Follow-up assessment at six months will include biomarkers of PrEP uptake and surveys.
DISCUSSION


This will be the first randomized controlled trial to determine whether interactive feedback counselling leads to uptake of HIV prevention methods such as PrEP and reduces risky sexual behavior. If successful, policymakers could consider such an intervention in school-based education campaigns or as post-HIV-testing counselling for young people.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT03565575. Registered on 21 June 2018.",2019,This is a matched-cluster randomized controlled trial which will compare an interactive tablet-based education intervention against a control with no intervention.,"['young women in Manicaland, East Zimbabwe', '1200 HIV-negative young women aged 18-24\u2009years, not on PrEP at baseline, will be eligible', 'adolescent girls and young women remains high in sub-Saharan Africa']","['pre-exposure prophylaxis (PrEP) through interactive feedback-based counselling with and without community engagement', 'oral pre-exposure prophylaxis (PrEP', 'interactive digital tablet-based counselling session', 'interactive tablet-based education intervention', 'interactive feedback counselling']",['risky sexual behavior'],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0001738', 'cui_str': 'Subsaharan Africa'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}]",1200.0,0.205144,This is a matched-cluster randomized controlled trial which will compare an interactive tablet-based education intervention against a control with no intervention.,"[{'ForeName': 'Ranjeeta', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': 'Department of Health Policy, London School of Economics and Political Science, Cowdray House, London, WC2 2AE, UK. r.a.thomas@lse.ac.uk.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Skovdal', 'Affiliation': 'Section of Health Services Research, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5 opg. B, Postb, 15, Building: 15.0.17, 1014, København K, Denmark.'}, {'ForeName': 'Matteo M', 'Initials': 'MM', 'LastName': 'Galizzi', 'Affiliation': 'Department of Psychological and Behavioural Science, London School of Economics and Political Science, London, WC2 2AE, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Schaefer', 'Affiliation': ""Department of Infectious Disease Epidemiology, Imperial College London, St Mary's Campus Norfolk Place, London, W2 1PG, UK.""}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Moorhouse', 'Affiliation': ""Department of Infectious Disease Epidemiology, Imperial College London, St Mary's Campus Norfolk Place, London, W2 1PG, UK.""}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Nyamukapa', 'Affiliation': ""Department of Infectious Disease Epidemiology, Imperial College London, St Mary's Campus Norfolk Place, London, W2 1PG, UK.""}, {'ForeName': 'Rufurwokuda', 'Initials': 'R', 'LastName': 'Maswera', 'Affiliation': 'Biomedical Research and Training Institute, 10 Seagrave, Avondale, Harare, Zimbabwe.'}, {'ForeName': 'Phyllis', 'Initials': 'P', 'LastName': 'Mandizvidza', 'Affiliation': 'Biomedical Research and Training Institute, 10 Seagrave, Avondale, Harare, Zimbabwe.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Hallett', 'Affiliation': ""Department of Infectious Disease Epidemiology, Imperial College London, St Mary's Campus Norfolk Place, London, W2 1PG, UK.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gregson', 'Affiliation': ""Department of Infectious Disease Epidemiology, Imperial College London, St Mary's Campus Norfolk Place, London, W2 1PG, UK.""}]",Trials,['10.1186/s13063-019-3791-8']
833,30876658,"Physical Activity, Quality of Life, and Biomarkers in Atrial Fibrillation and Heart Failure With Preserved Ejection Fraction (from the NEAT-HFpEF Trial).","Although atrial fibrillation/atrial flutter (AF/AFL) and heart failure with preserved ejection fraction (HFpEF) frequently coexist, the influence of AF/AFL on physical activity, N-terminal pro-B-type natriuretic peptide (NT-proBNP), and quality of life in HFpEF is unclear and could have relevance to HFpEF trial design. We evaluated the association between AF/AFL and volitional physical activity, functional performance, NT-proBNP, and quality of life in patients with HFpEF in the Nitrate's Effect on Activity Tolerance (NEAT)-HFpEF trial. Of 99 patients with accelerometer data, 35 (35%) had AF/AFL. There were no differences between AF/AFL versus no AF/AFL in baseline average daily accelerometer units (ADAUs; 9.06 ± 0.54 vs 9.06 ± 0.48, p = 0.75), hours active per day (9.7 ± 2.3 vs 9.2 ± 2.2, p = 0.86), or 6-minute walk distance (6MWD; 307 ± 136m vs 321 ± 110m, p = 0.85). AF/AFL status was associated with higher baseline NT-proBNP (586 [25th to 75th percentile: 291 to 1254] pg/ml vs 154 [25th to 75th percentile: 92 to 288] pg/ml, p <0.001) and Kansas City Cardiomyopathy Questionnaire scores (69 [25th to 75th percentile: 46 to 88] vs 48 [25th to 75th percentile: 37 to 70], p = 0.01). Although treatment responses to isosorbide mononitrate measured by change in ADAUs, hours active per day, or 6MWD did not vary by AF/AFL status (interaction p >0.05 for all), AF/AFL patients had greater reductions in NT-proBNP after isosorbide mononitrate than patients without AF/AFL (interaction p <0.001), possibly due to regression to the mean. In conclusion, baseline measures and treatment-related changes in volitional physical activity (ADAUs) and functional performance (6MWD) did not differ by AF/AFL in NEAT-HFpEF, whereas NT-proBNP did. In HFpEF-where AF/AFL prevalence is high-functional measures may be superior to natriuretic peptides as trial endpoints.",2019,"There were no differences between AF/AFL versus no AF/AFL in baseline average daily accelerometer units (ADAUs; 9.06 ± 0.54 vs 9.06 ± 0.48, p = 0.75), hours active per day (9.7 ± 2.3 vs 9.2 ± 2.2, p = 0.86), or 6-minute walk distance (6MWD; 307 ± 136m vs 321 ± 110m, p = 0.85).","['99 patients with accelerometer data, 35 (35%) had AF/AFL', ""patients with HFpEF in the Nitrate's Effect on Activity Tolerance (NEAT)-HFpEF trial""]",[],"['Kansas City Cardiomyopathy Questionnaire scores', 'AF/AFL status', 'NT-proBNP', 'volitional physical activity (ADAUs) and functional performance (6MWD', 'AF/AFL and volitional physical activity, functional performance, NT-proBNP, and quality of life', 'Physical Activity, Quality of Life, and Biomarkers in Atrial Fibrillation and Heart Failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1319203', 'cui_str': 'Activity tolerance'}]",[],"[{'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3853978'}, {'cui': 'C0034380'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",99.0,0.0336532,"There were no differences between AF/AFL versus no AF/AFL in baseline average daily accelerometer units (ADAUs; 9.06 ± 0.54 vs 9.06 ± 0.48, p = 0.75), hours active per day (9.7 ± 2.3 vs 9.2 ± 2.2, p = 0.86), or 6-minute walk distance (6MWD; 307 ± 136m vs 321 ± 110m, p = 0.85).","[{'ForeName': 'Ravi B', 'Initials': 'RB', 'LastName': 'Patel', 'Affiliation': 'Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois. Electronic address: ravi.patel@northwestern.edu.'}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Brigham and Women's Heart & Vascular Center, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Redfield', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}]",The American journal of cardiology,['10.1016/j.amjcard.2019.02.025']
834,30620389,Association between age and sex and mortality after adjuvant therapy for renal cancer.,"BACKGROUND


In phase 3 trials of patients with resected high-risk renal cell carcinoma, adjuvant sunitinib has demonstrated no overall survival (OS) benefit, an uncertain disease-free survival (DFS) benefit, and increased toxicity versus placebo. To identify patients who may derive benefit or harm from adjuvant therapy, the authors assessed the effects of age and sex on treatment outcomes in the phase 3 Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Cancer (ASSURE) trial.
METHODS


The authors conducted a post hoc subgroup analysis of age and sex among patients in the ASSURE trial. Adjusted hazard ratios (HRs) for OS and DFS were evaluated with sunitinib or sorafenib versus placebo in 4 patient subgroups defined by sex and median age at the time of the study.
RESULTS


Sunitinib treatment was associated with decreased OS (HR, 2.21; 95% confidence interval, 1.29-3.80) among women aged >56 years, but not in women aged ≤56 years or men of any age. Similar associations with age and sex were observed for DFS, but these were not statistically significant (women aged >56 years: HR, 1.41 [95% confidence interval, 0.94-2.10]). No such association was found for sorafenib. The interaction by age and sex on mortality was found to be statistically significant for sunitinib (P = .01), but not sorafenib (P = .10).
CONCLUSIONS


Adjuvant sunitinib may increase mortality among older women with renal cell carcinoma. Given the recent approval of adjuvant sunitinib for patients with high-risk resected renal cell carcinoma, additional studies are needed to confirm these findings.",2019,"The interaction by age and sex on mortality was found to be statistically significant for sunitinib (P = .01), but not sorafenib (P = .10).
","['renal cancer', 'patients with resected high-risk renal cell carcinoma', 'patients with high-risk resected renal cell carcinoma', 'older women with renal cell carcinoma', 'for Unfavorable Renal Cancer (ASSURE) trial']","['sunitinib or sorafenib', 'placebo', 'Sorafenib or Sunitinib']","['mortality', 'Adjusted hazard ratios (HRs) for OS and DFS', 'overall survival (OS) benefit']","[{'cui': 'C0740457', 'cui_str': 'Cancer of Kidney'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.20279,"The interaction by age and sex on mortality was found to be statistically significant for sunitinib (P = .01), but not sorafenib (P = .10).
","[{'ForeName': 'Ronac', 'Initials': 'R', 'LastName': 'Mamtani', 'Affiliation': 'Abramson Cancer Center, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Xin Victoria', 'Initials': 'XV', 'LastName': 'Wang', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Bishal', 'Initials': 'B', 'LastName': 'Gyawali', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'DiPaola', 'Affiliation': 'University of Kentucky College of Medicine, Lexington, Kentucky.'}, {'ForeName': 'C Neill', 'Initials': 'CN', 'LastName': 'Epperson', 'Affiliation': 'Penn PROMOTES Research on Sex and Gender in Health, Department of Psychiatry, Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Naomi B', 'Initials': 'NB', 'LastName': 'Haas', 'Affiliation': 'Abramson Cancer Center, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Janice P', 'Initials': 'JP', 'LastName': 'Dutcher', 'Affiliation': 'Cancer Research Foundation Inc, Chappaqua, New York.'}]",Cancer,['10.1002/cncr.31955']
835,31094434,Parenting a child with cancer: a couple-based approach.,"Couples co-parenting a child with cancer face significant stressors that can adversely affect their couple relationship. How parents respond as a couple may affect the psychological adjustment of each parent and the child, as well as the ability of the family to cope with the child's illness. The purpose of this study was to assess the feasibility and acceptability of a couple-based intervention for parents of children with cancer. We conducted a randomized pilot intervention study (N = 21 couples randomized with a 2:1 allocation to the couple-based intervention or education control) testing a six-session, telephone-based intervention that trained couples in relationship skills to help them care for their child, strengthen their relationship, and support each other. We examined feasibility and acceptability of the intervention to the parents. In this study, 56% of eligible couples agreed to participate; 82% of randomized couples completed post-intervention surveys, and 62% completed all six sessions. Satisfaction with the intervention was high (mean = 3.3 on a 4-point scale). Changes in both groups were small in magnitude and mixed in direction, with some outcomes favoring the couple-based intervention and other favoring the education condition. Supporting couples is important to optimize individual and parental functioning when a child has cancer. However, there are significant challenges to delivering couple-based interventions to these parents. More research is needed to establish optimal timing and content of couple-based interventions for these parents as well as feasible methods of delivery.",2019,"Changes in both groups were small in magnitude and mixed in direction, with some outcomes favoring the couple-based intervention and other favoring the education condition.","['parents of children with cancer', 'Parenting a child with cancer']","['couple-based intervention or education control) testing a six-session, telephone-based intervention that trained couples in relationship skills to help them care', 'couple-based intervention']","['Satisfaction', 'feasibility and acceptability']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",21.0,0.0264426,"Changes in both groups were small in magnitude and mixed in direction, with some outcomes favoring the couple-based intervention and other favoring the education condition.","[{'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Porter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Donald H', 'Initials': 'DH', 'LastName': 'Baucom', 'Affiliation': 'Department of Psychology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Bonner', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Linardic', 'Affiliation': 'Department of Pediatrics-Hematology/Oncology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Kazak', 'Affiliation': ""Center for Healthcare Delivery Science, Nemours Children's Health System, Sidney Kimmel Medical College of Thomas Jefferson University, Wilmington, DE, USA.""}]",Translational behavioral medicine,['10.1093/tbm/ibz016']
836,31094440,A four-group experiment to improve Western high school students' sun protection behaviors.,"Multicomponent skin cancer preventive interventions for adolescents that aim to decrease ultraviolet radiation (UVR) exposure and sunburns are particularly needed given their intentional tanning and infrequent use of sun protection. The purpose of this study was to conduct an early-phase study within the Multiphase Optimization Strategy framework that experimentally tested four unique intervention components targeting high school students' skin cancer prevention behaviors. Schools (11 total, N = 1,573 students) were assigned to receive one of four interventions: skin cancer education (control), education plus a sunscreen activity (to illustrate sunscreen's UVR-blocking properties), or behavior change worksheet (sun protection goal setting and planning) or receipt of a personalized UV damage photograph (photograph of facial damage). Sun protection, sunburn, and tanning outcomes were assessed before intervention and at 1-month follow-up. Within- and between-intervention changes in outcomes were examined using generalized estimating equation modeling. All interventions were associated with significant improvements in sun protection. The photograph was superior in controlling intentional tanning and sunburn when compared to the behavior change worksheet (ps < .05). In contrast, the worksheet was associated with greater increases in sun protection use when compared with the photograph (ps < .05). In this experiment testing four skin cancer preventive intervention components that varied in approach, content, and interactivity, the behavior change worksheet was superior in improving sun protection use whereas the UV photograph was superior in controlling intentional tanning and sunburn. Future randomized trials to test combinations of these intervention components are needed, and could identify mechanisms underlying improved effects and demographic or behavioral moderators of intervention effects.",2019,"In contrast, the worksheet was associated with greater increases in sun protection use when compared with the photograph (ps < .05).","['Schools (11 total, N = 1,573 students', ""school students' skin cancer prevention behaviors""]","[""skin cancer education (control), education plus a sunscreen activity (to illustrate sunscreen's UVR-blocking properties), or behavior change worksheet (sun protection goal setting and planning) or receipt of a personalized UV damage photograph (photograph of facial damage"", 'Multicomponent skin cancer preventive interventions']","['sun protection', 'sun protection use', 'Sun protection, sunburn, and tanning outcomes']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038818', 'cui_str': 'Sunscreens'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0441468', 'cui_str': 'Photograph (physical object)'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}]","[{'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0038814', 'cui_str': 'Sunburn'}, {'cui': 'C0039295', 'cui_str': 'Tannings'}]",1573.0,0.0221638,"In contrast, the worksheet was associated with greater increases in sun protection use when compared with the photograph (ps < .05).","[{'ForeName': 'Yelena P', 'Initials': 'YP', 'LastName': 'Wu', 'Affiliation': 'Department of Dermatology, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Bridget G', 'Initials': 'BG', 'LastName': 'Parsons', 'Affiliation': 'Cancer Control and Population Sciences, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Nagelhout', 'Affiliation': 'Department of Family and Preventive Medicine, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Haaland', 'Affiliation': 'Cancer Control and Population Sciences, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'Cancer Control and Population Sciences, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Zaugg', 'Affiliation': 'Cancer Control and Population Sciences, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Heloisa', 'Initials': 'H', 'LastName': 'Caputo', 'Affiliation': 'Cancer Control and Population Sciences, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Riley', 'Initials': 'R', 'LastName': 'Lensink', 'Affiliation': 'Cancer Control and Population Sciences, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Garrett', 'Initials': 'G', 'LastName': 'Harding', 'Affiliation': 'Community Outreach and Prevention Education, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Yancey', 'Affiliation': 'Community Outreach and Prevention Education, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Stephanie Z', 'Initials': 'SZ', 'LastName': 'Klein', 'Affiliation': 'Department of Dermatology, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Sancy A', 'Initials': 'SA', 'LastName': 'Leachman', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Tercyak', 'Affiliation': 'Cancer Prevention and Control Program, Georgetown Lombardi Comprehensive Cancer Center, NW Washington, DC, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibz021']
837,31094443,"Exercise effects on quality of life, mood, and self-worth in overweight children: the SMART randomized controlled trial.","Overweight children are at risk for poor quality of life (QOL), depression, self-worth, and behavior problems. Exercise trials with children have shown improved mood and self-worth. Few studies utilized an attention control condition, QOL outcomes, or a follow-up evaluation after the intervention ends. The purpose is to test effects of an exercise program versus sedentary program on psychological factors in overweight children. One hundred seventy-five overweight children (87% black, 61% female, age 9.7 ± 0.9 years, 73% obese) were randomized to an 8 month aerobic exercise or sedentary after-school program. Depressive symptoms, anger expression, self-worth, and QOL were measured at baseline and post-test. Depressive symptoms and QOL were also measured at follow-up. Intent-to-treat mixed models evaluated intervention effects, including sex differences. At post-test, QOL, depression, and self-worth improved; no group by time or sex by group by time interaction was detected for QOL or self-worth. Boys' depressive symptoms improved more and anger control decreased in the sedentary intervention relative to the exercise intervention at post-test. At follow-up, depressive symptoms in boys in the sedentary group decreased more than other groups. Exercise provided benefits to QOL, depressive symptoms, and self-worth comparable to a sedentary program. Sedentary programs with games and artistic activities, interaction with adults and peers, and behavioral structure may be more beneficial to boys' mood than exercise. Some benefits of exercise in prior studies are probably attributable to program elements such as attention from adults. Trial Registration: Clinicaltrials.gov, NCT02227095.",2019,Boys' depressive symptoms improved more and anger control decreased in the sedentary intervention relative to the exercise intervention at post-test.,"['overweight children', 'Overweight children', 'One hundred seventy-five overweight children (87% black, 61% female, age 9.7 ± 0.9 years, 73% obese']","['exercise program versus sedentary program', 'aerobic exercise or sedentary after-school program']","['Depressive symptoms, anger expression, self-worth, and QOL', 'quality of life (QOL), depression, self-worth, and behavior problems', 'QOL, depression, and self-worth improved; no group by time or sex', 'quality of life, mood, and self-worth', 'depressive symptoms', 'Depressive symptoms and QOL', ""Boys' depressive symptoms improved more and anger control""]","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034380'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",175.0,0.0667887,Boys' depressive symptoms improved more and anger control decreased in the sedentary intervention relative to the exercise intervention at post-test.,"[{'ForeName': 'Celestine F', 'Initials': 'CF', 'LastName': 'Williams', 'Affiliation': 'Department of Population Health Sciences, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Eduardo E', 'Initials': 'EE', 'LastName': 'Bustamante', 'Affiliation': 'Department of Kinesiology & Nutrition, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Waller', 'Affiliation': 'Biostatistics & Data Science, Department of Population Health Sciences, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Davis', 'Affiliation': 'Department of Population Health Sciences, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibz015']
838,30996057,Network-targeted stimulation engages neurobehavioral hallmarks of age-related memory decline.,"OBJECTIVE


To test whether targeting hippocampal-cortical brain networks with high-frequency transcranial magnetic stimulation in older adults influences behavioral and neural measures characteristic of age-related memory impairment.
METHODS


Fifteen adults aged 64 to 80 years (mean = 72 years) completed a single-blind, sham-controlled experiment. Stimulation targets in parietal cortex were determined based on fMRI connectivity with the hippocampus. Recollection and recognition memory were assessed after 5 consecutive daily sessions of full-intensity stimulation vs low-intensity sham stimulation using a within-subjects crossover design. Neural correlates of recollection and recognition memory formation were obtained via fMRI, measured within the targeted hippocampal-cortical network vs a control frontal-parietal network. These outcomes were measured approximately 24 hours after the final stimulation session.
RESULTS


Recollection was specifically impaired in older adults compared to a young-adult control sample at baseline. Relative to sham, stimulation improved recollection to a greater extent than recognition. Stimulation increased recollection fMRI signals throughout the hippocampal-cortical network, including at the targeted location of the hippocampus. Effects of stimulation on fMRI recollection signals were greater than those for recognition and were greater in the targeted network compared to the control network.
CONCLUSIONS


Age-related recollection impairments were causally related to hippocampal-cortical network function in older adults. Stimulation selectively modified neural and behavioral hallmarks of age-related memory impairment, indicating effective engagement of memory intervention targets in older adults.",2019,"Effects of stimulation on fMRI recollection signals were greater than those for recognition and were greater in the targeted network compared to the control network.
","['Fifteen adults aged 64 to 80 years (mean = 72 years', 'older adults']",['hippocampal-cortical brain networks with high-frequency transcranial magnetic stimulation'],"['Recollection and recognition memory', 'recollection fMRI signals', 'fMRI recollection signals']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]",15.0,0.122317,"Effects of stimulation on fMRI recollection signals were greater than those for recognition and were greater in the targeted network compared to the control network.
","[{'ForeName': 'Aneesha S', 'Initials': 'AS', 'LastName': 'Nilakantan', 'Affiliation': ""From the Departments of Medical Social Sciences (A.S.N., E.L.K., J.L.V.), Ken and Ruth Davee Department of Neurology (M.-M.M., S.V., J.L.V.), and Psychiatry and Behavioral Sciences (S.W., J.L.V.), Cognitive Neurology and Alzheimer's Disease Center (A.S.N., M.-M.M., S.W.), Feinberg School of Medicine, Northwestern University, Chicago, IL.""}, {'ForeName': 'M-Marsel', 'Initials': 'MM', 'LastName': 'Mesulam', 'Affiliation': ""From the Departments of Medical Social Sciences (A.S.N., E.L.K., J.L.V.), Ken and Ruth Davee Department of Neurology (M.-M.M., S.V., J.L.V.), and Psychiatry and Behavioral Sciences (S.W., J.L.V.), Cognitive Neurology and Alzheimer's Disease Center (A.S.N., M.-M.M., S.W.), Feinberg School of Medicine, Northwestern University, Chicago, IL.""}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Weintraub', 'Affiliation': ""From the Departments of Medical Social Sciences (A.S.N., E.L.K., J.L.V.), Ken and Ruth Davee Department of Neurology (M.-M.M., S.V., J.L.V.), and Psychiatry and Behavioral Sciences (S.W., J.L.V.), Cognitive Neurology and Alzheimer's Disease Center (A.S.N., M.-M.M., S.W.), Feinberg School of Medicine, Northwestern University, Chicago, IL.""}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Karp', 'Affiliation': ""From the Departments of Medical Social Sciences (A.S.N., E.L.K., J.L.V.), Ken and Ruth Davee Department of Neurology (M.-M.M., S.V., J.L.V.), and Psychiatry and Behavioral Sciences (S.W., J.L.V.), Cognitive Neurology and Alzheimer's Disease Center (A.S.N., M.-M.M., S.W.), Feinberg School of Medicine, Northwestern University, Chicago, IL.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'VanHaerents', 'Affiliation': ""From the Departments of Medical Social Sciences (A.S.N., E.L.K., J.L.V.), Ken and Ruth Davee Department of Neurology (M.-M.M., S.V., J.L.V.), and Psychiatry and Behavioral Sciences (S.W., J.L.V.), Cognitive Neurology and Alzheimer's Disease Center (A.S.N., M.-M.M., S.W.), Feinberg School of Medicine, Northwestern University, Chicago, IL.""}, {'ForeName': 'Joel L', 'Initials': 'JL', 'LastName': 'Voss', 'Affiliation': ""From the Departments of Medical Social Sciences (A.S.N., E.L.K., J.L.V.), Ken and Ruth Davee Department of Neurology (M.-M.M., S.V., J.L.V.), and Psychiatry and Behavioral Sciences (S.W., J.L.V.), Cognitive Neurology and Alzheimer's Disease Center (A.S.N., M.-M.M., S.W.), Feinberg School of Medicine, Northwestern University, Chicago, IL. joel-voss@northwestern.edu.""}]",Neurology,['10.1212/WNL.0000000000007502']
839,30633331,The effects of a randomized trial of brief forms of stress management on RAGE-associated S100A8/A9 in patients with breast cancer undergoing primary treatment.,"BACKGROUND


Women with breast cancer (BCa) experience heightened distress, which is related to greater inflammation and poorer outcomes. The s100 protein family facilitates the inflammatory response by regulating myeloid cell function through the binding of Toll-like receptor 4 and the receptor for advanced glycation end products (RAGE). The heterodimer s100A8/A9 RAGE ligand is associated with hastened tumor development and metastasis. Previously, a 10-week stress-management intervention using cognitive behavioral therapy (CBT) and relaxation training (RT) was associated with less leukocyte inflammatory gene expression in patients with BCa; however, its impact on s100A8/A9 was not examined. Because a 10-week intervention may be impractical during primary treatment for BCa, the authors developed briefer forms of CBT and RT and demonstrated their efficacy in reducing distress over 12 months of primary treatment. Here, the effects of these briefer interventions were tested effects on s100A8/A9 levels over the initial 12 months of BCa treatment.
METHODS


Postsurgical patients with BCa (stage 0-IIIB) were randomized to a 5-week, group-based condition: CBT, RT, or health education control (HE). At baseline and at 12 months, women provided sera from which s100A8/A9 levels were determined using any enzyme-linked immunosorbent assay.
RESULTS


Participants (mean age ± standard deviation, 54.81 ± 9.63 years) who were assigned to either CBT (n = 41) or RT (n = 38) had significant s100A8/A9 decreases over 12 months compared with those who were assigned to HE (n = 44; F [1,114]   = 4.500; P = .036) controlling for age, stage, time since surgery, and receipt of chemotherapy or radiation. Greater increases in stress-management skills from preintervention to postintervention predicted greater reductions in s100A8/A9 levels over 12 months (β = -0.379; t [101]   = -4.056; P < .001).
CONCLUSIONS


Brief, postsurgical, group-based stress management reduces RAGE-associated s100A8/A9 ligand levels during primary treatment for BCa.",2019,Greater increases in stress-management skills from preintervention to postintervention predicted greater reductions in s100A8/A9 levels over 12 months (β = -0.379;,"['Women with breast cancer (BCa', 'patients with breast cancer undergoing primary treatment', 'patients with BCa', 'Participants (mean age\xa0±\xa0standard deviation, 54.81\xa0±\xa09.63 years) who were assigned to either', 'Postsurgical patients with BCa (stage 0-IIIB']","['stress management on RAGE-associated S100A8/A9', 'chemotherapy or radiation', 'CBT', 'cognitive behavioral therapy (CBT) and relaxation training (RT', 'group-based condition: CBT, RT, or health education control (HE']","['stress-management skills', 's100A8/A9 levels']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0441763', 'cui_str': 'Stage 0 (qualifier value)'}]","[{'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0034634', 'cui_str': 'Rage'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0282333', 'cui_str': 'Relaxation Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0018701'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0304827,Greater increases in stress-management skills from preintervention to postintervention predicted greater reductions in s100A8/A9 levels over 12 months (β = -0.379;,"[{'ForeName': 'Chloe J', 'Initials': 'CJ', 'LastName': 'Taub', 'Affiliation': 'Department of Psychology, University of Miami, Coral Gables, Florida.'}, {'ForeName': 'Marc E', 'Initials': 'ME', 'LastName': 'Lippman', 'Affiliation': 'Sylvester Cancer Center, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Barry I', 'Initials': 'BI', 'LastName': 'Hudson', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Bonnie B', 'Initials': 'BB', 'LastName': 'Blomberg', 'Affiliation': 'Sylvester Cancer Center, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Diaz', 'Affiliation': 'Department of Microbiology and Immunology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Fisher', 'Affiliation': 'Department of Psychology, University of Miami, Coral Gables, Florida.'}, {'ForeName': 'Erica R', 'Initials': 'ER', 'LastName': 'Nahin', 'Affiliation': 'Department of Psychology, University of Miami, Coral Gables, Florida.'}, {'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'Lechner', 'Affiliation': 'Sylvester Cancer Center, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Taekyoung', 'Initials': 'T', 'LastName': 'Kwak', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Gyong Ha', 'Initials': 'GH', 'LastName': 'Hwang', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Antoni', 'Affiliation': 'Department of Psychology, University of Miami, Coral Gables, Florida.'}]",Cancer,['10.1002/cncr.31965']
840,31125101,Short- and Long-term Effects of a Mobile Phone App in Conjunction With Brief In-Person Counseling on Physical Activity Among Physically Inactive Women: The mPED Randomized Clinical Trial.,"Importance


Mobile phone applications (apps) and activity trackers allow researchers to remotely deliver an intervention and monitor physical activity but have not been rigorously evaluated for longer periods.
Objective


To determine whether a mobile phone-based physical activity education app, in conjunction with brief in-person counseling, increases and then maintains levels of physical activity.
Design, Setting, and Participants


In this parallel randomized clinical trial, community-dwelling physically inactive women recruited between May 2011 and April 2014 were randomized in equal proportions into the control (n = 69), regular (n = 71), and plus (n = 70) groups. Data were analyzed using intention to treat from September 16, 2016, through June 30, 2018.
Interventions


The regular and plus groups were instructed to use the app on their mobile phone and an accelerometer every day for 3 months and attend brief in-person counseling. During the 6-month maintenance period, the plus group continued to use the app and accelerometer, while the regular group stopped using the app but continued using the accelerometer. The control group used the accelerometer throughout.
Main Outcomes and Measures


The primary and secondary outcomes were daily accelerometer-measured total steps and time spent in moderate to vigorous physical activity (MVPA).
Results


The 210 participants had a mean (SD) age of 52.4 (11.0) years. At baseline, the mean (SD) daily total steps by accelerometer in the control, regular, and plus groups were 5384 (2920), 5063 (2526), and 5837 (3235), respectively. During the 3-month intervention period, daily steps and MVPA increased in the combined regular and plus groups compared with the control group (between-group differences, 2060 steps per day; 95% CI, 1296-2825 steps per day; P < .001 and 18.2 min/d MVPA; 95% CI, 10.9-25.4 min/d MVPA; P < .001). During the subsequent 6-month maintenance period, mean activity level remained higher in the combined plus and regular groups than among controls (between-group difference, 1360 steps per day; 95% CI, 694-2026 steps per day; P <. 001), but trends in total daily steps and MVPA were similar in the plus and regular groups.
Conclusions and Relevance


In this trial, the intervention groups substantially increased their physical activity. However, use of both the app and accelerometer for an additional 6 months after the initial 3-month intervention did not help to maintain increases in physical activity compared with continued use of the accelerometer alone.
Trial Registration


ClinicalTrials.gov identifier: NCT01280812.",2019,"During the subsequent 6-month maintenance period, mean activity level remained higher in the combined plus and regular groups than among controls (between-group difference, 1360 steps per day; 95% CI, 694-2026 steps per day; P <. ","['community-dwelling physically inactive women recruited between May 2011 and April 2014', '210 participants had a mean (SD) age of 52.4 (11.0) years', 'Physically Inactive Women']","['mobile phone-based physical activity education', 'Mobile Phone App']","['daily accelerometer-measured total steps and time spent in moderate to vigorous physical activity (MVPA', 'mean activity level', 'mean (SD) daily total steps', 'Physical Activity', 'total daily steps and MVPA', 'physical activity', 'daily steps and MVPA']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.105574,"During the subsequent 6-month maintenance period, mean activity level remained higher in the combined plus and regular groups than among controls (between-group difference, 1360 steps per day; 95% CI, 694-2026 steps per day; P <. ","[{'ForeName': 'Yoshimi', 'Initials': 'Y', 'LastName': 'Fukuoka', 'Affiliation': 'Department of Physiological Nursing, Institute for Health & Aging, School of Nursing, University of California, San Francisco.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Haskell', 'Affiliation': 'Stanford Prevention Research Center, Stanford University, Palo Alto, California.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vittinghoff', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.4281']
841,31740727,Comparison of pressure- and volume-controlled ventilation during laparoscopic colectomy in patients with colorectal cancer.,"This study investigated the differences in airway mechanics and postoperative respiratory complications using two mechanical ventilation modalities and the relationship between biomarkers and postoperative respiratory complications in patients with colorectal cancer who underwent laparoscopic colectomy. Forty-six patients with colorectal cancer scheduled for laparoscopic colectomy were randomly allocated to receive mechanical ventilation using either volume-controlled ventilation (VCV) (n = 23) or pressure-controlled ventilation (PCV) (n = 23). Respiratory parameters were measured and plasma sRAGE and S100A12 were collected 20 minutes after the induction of anesthesia in the supine position without pneumoperitoneum (T1), 40 minutes after 30° Trendelenburg position with pneumoperitoneum (T2), at skin closure in the supine position (T3), and 24 hours after the operation (T4). The peak airway pressure (Ppeak) at T2 was lower in the PCV group than in the VCV group. The plateau airway pressures (Pplat) at T2 and T3 were higher in the VCV group than in the PCV group. Plasma levels of sRAGE at T2 and T3 were 1.6- and 1.4-fold higher in the VCV group than in the PCV group, while plasma S100A12 levels were 2.6- and 2.2-fold higher in the VCV group than in the PCV group, respectively. There were significant correlations between Ppeak and sRAGE, and between Ppeak and S100A12. There were also correlations between Pplat and sRAGE, and between Pplat and S100A12. sRAGE and S100A12 levels at T2 and T3 showed high sensitivity and specificity for postoperative respiratory complications. Postoperative respiratory complications were 3-fold higher in the VCV group than in the PCV group. In conclusion, during laparoscopic colectomy in patients with colorectal cancer, the peak airway pressure, the incidence of postoperative respiratory complications, and plasma sRAGE and S100A12 levels were lower in the PCV group than in the VCV group. Intra- and postoperative plasma sRAGE and S100A12 were useful for predicting the development of postoperative respiratory complications.",2019,sRAGE and S100A12 levels at T2 and T3 showed high sensitivity and specificity for postoperative respiratory complications.,"['Forty-six patients with colorectal cancer scheduled for laparoscopic colectomy', 'patients with colorectal cancer', 'patients with colorectal cancer who underwent laparoscopic colectomy']","['pressure- and volume-controlled ventilation', 'mechanical ventilation using either volume-controlled ventilation (VCV) (n\u2009=\u200923) or pressure-controlled ventilation (PCV', 'laparoscopic colectomy', 'VCV', 'mechanical ventilation modalities']","['Plasma levels of sRAGE', 'sRAGE and S100A12 levels', 'plasma S100A12 levels', 'peak airway pressure (Ppeak', 'Postoperative respiratory complications', 'plateau airway pressures (Pplat', 'peak airway pressure, the incidence of postoperative respiratory complications, and plasma sRAGE and S100A12 levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1517722', 'cui_str': 'Laparoscopic colectomy'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1320708', 'cui_str': 'Volume controlled ventilation'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0564626', 'cui_str': 'Pressure controlled ventilation (procedure)'}, {'cui': 'C0018935', 'cui_str': 'Erythrocyte Volume, Packed'}, {'cui': 'C1517722', 'cui_str': 'Laparoscopic colectomy'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4019423', 'cui_str': 'ENRAGE Protein'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0161818', 'cui_str': 'Respiratory complication'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",46.0,0.0391975,sRAGE and S100A12 levels at T2 and T3 showed high sensitivity and specificity for postoperative respiratory complications.,"[{'ForeName': 'Sangbong', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Division of Respirology, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea.'}, {'ForeName': 'So Young', 'Initials': 'SY', 'LastName': 'Yang', 'Affiliation': 'Anesthesiology and Pain Medicine, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Geun Joo', 'Initials': 'GJ', 'LastName': 'Choi', 'Affiliation': 'Anesthesiology and Pain Medicine, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Beom Gyu', 'Initials': 'BG', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyun', 'Initials': 'H', 'LastName': 'Kang', 'Affiliation': 'Anesthesiology and Pain Medicine, Chung-Ang University College of Medicine, Seoul, Korea. roman00@naver.com.'}]",Scientific reports,['10.1038/s41598-019-53503-9']
842,30396098,Testing a brief motivational-interviewing educational commitment module for at-risk college drinkers: A randomized trial.,"BACKGROUND


The goal of the present study was to test the drink and harm reduction effects of a novel educational commitment (EC) module as a complement to a standard brief MI protocol (i.e., the Brief Alcohol Screening and Intervention for College Students; BASICS, Dimeff, Baer, Kivlahan, & Marlatt, 1999).
METHODS


Using a randomized trial design, 180 university students were assigned to one of three conditions: Information, BASICS, or BASICS+EC. Participants completed an alcohol consumption interview and measures of alcohol-related problems, partying decision-making, subjective student role investment, and self-control-related traits at baseline and at two- and nine-month follow-ups.
RESULTS


Linear models showed significant condition effects for two-month and nine-month drink quantity, but not for alcohol problems/consequences. Secondary outcome analyses showed significant condition effects for two-month high-risk high-reward partying decision-making and nine-month conscientiousness. Somewhat larger-sized decreases in consumption were observed at two months for the BASICS+EC condition compared to the BASICS condition, although these differences were not present at nine months.
CONCLUSIONS


The differential efficacy between the BASICS and BASICS+EC conditions compared to the Information condition reinforces the utility of in-person feedback modalities as more intensive indicated prevention strategies for at-risk college drinkers. The limited differential efficacy for BASICS+EC compared to BASICS suggests a brief MI module for the academic/vocational aspects of the student role is not associated with greater long-term drink and harm reduction. Future research should examine more intensive educational commitment modalities, the utility of on-going academic goal and action feedback, and mechanisms of differential efficacy across intervention groups.",2019,"RESULTS


Linear models showed significant condition effects for two-month and nine-month drink quantity, but not for alcohol problems/consequences.","['for at-risk college drinkers', 'at-risk college drinkers', '180 university students']","['motivational-interviewing educational commitment module', 'BASICS+EC', 'novel educational commitment (EC) module']","['alcohol consumption interview and measures of alcohol-related problems, partying decision-making, subjective student role investment, and self-control-related traits', 'significant condition effects for two-month high-risk high-reward partying decision-making and nine-month conscientiousness']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0021953', 'cui_str': 'Investments'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}]",,0.0370845,"RESULTS


Linear models showed significant condition effects for two-month and nine-month drink quantity, but not for alcohol problems/consequences.","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Bogg', 'Affiliation': 'Wayne State University, Department of Psychology, United States. Electronic address: tdbogg@gmail.com.'}, {'ForeName': 'Michelle R', 'Initials': 'MR', 'LastName': 'Marshbanks', 'Affiliation': 'Meridian Health Services, United States.'}, {'ForeName': 'Heather K', 'Initials': 'HK', 'LastName': 'Doherty', 'Affiliation': 'Wayne State University, Department of Psychology, United States.'}, {'ForeName': 'Phuong T', 'Initials': 'PT', 'LastName': 'Vo', 'Affiliation': 'Michigan State University, Department of Psychology, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2018.10.028']
843,30524137,Metabolomic consequences of genetic inhibition of PCSK9 compared with statin treatment.,"Background


Both statins and PCSK9 inhibitors lower blood low-density lipoprotein cholesterol (LDL-C) levels to reduce risk of cardiovascular events. To assess potential differences between metabolic effects of these two lipid-lowering therapies, we performed detailed lipid and metabolite profiling of a large randomized statin trial and compared the results with the effects of genetic inhibition of PCSK9, acting as a naturally occurring trial.
Methods


228 circulating metabolic measures were quantified by nuclear magnetic resonance spectroscopy, including lipoprotein subclass concentrations and their lipid composition, fatty acids, and amino acids, for 5,359 individuals (2,659 on treatment) in the PROspective Study of Pravastatin in the Elderly at Risk (PROSPER) trial at 6-months post-randomization. The corresponding metabolic measures were analyzed in eight population cohorts (N=72,185) using  PCSK9  rs11591147 as an unconfounded proxy to mimic the therapeutic effects of PCSK9 inhibitors.
Results


Scaled to an equivalent lowering of LDL-C, the effects of genetic inhibition of PCSK9 on 228 metabolic markers were generally consistent with those of statin therapy ( R   2 =0.88). Alterations in lipoprotein lipid composition and fatty acid distribution were similar. However, discrepancies were observed for very-low-density lipoprotein (VLDL) lipid measures. For instance, genetic inhibition of PCSK9 had weaker effects on lowering of VLDL-cholesterol compared with statin therapy (54% vs. 77% reduction, relative to the lowering effect on LDL-C;  P =2x10 -7  for heterogeneity). Genetic inhibition of PCSK9 showed no significant effects on amino acids, ketones, or a marker of inflammation (GlycA) whereas statin treatment weakly lowered GlycA levels.
Conclusions


Genetic inhibition of PCSK9 had similar metabolic effects to statin therapy on detailed lipid and metabolite profiles. However, PCSK9 inhibitors are predicted to have weaker effects on VLDL lipids compared with statins for an equivalent lowering of LDL-C, which potentially translate into smaller reductions in cardiovascular disease risk.",2018,"Genetic inhibition of PCSK9 showed no significant effects on amino acids, ketones, or a marker of inflammation (GlycA) whereas statin treatment weakly lowered GlycA levels.
",[],['Pravastatin'],"['amino acids, ketones, or a marker of inflammation (GlycA', 'blood low-density lipoprotein cholesterol (LDL-C) levels', 'lowering of VLDL-cholesterol', 'lipoprotein lipid composition and fatty acid distribution', 'lipoprotein subclass concentrations and their lipid composition, fatty acids, and amino acids']",[],"[{'cui': 'C0085542', 'cui_str': 'Pravastatin'}]","[{'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0022634', 'cui_str': 'Ketones'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005768'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0023826', 'cui_str': 'Pre-beta-Lipoprotein Cholesterol'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0445604', 'cui_str': 'Subclass (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",,0.0837646,"Genetic inhibition of PCSK9 showed no significant effects on amino acids, ketones, or a marker of inflammation (GlycA) whereas statin treatment weakly lowered GlycA levels.
","[{'ForeName': 'Eeva', 'Initials': 'E', 'LastName': 'Sliz', 'Affiliation': 'Center for Life Course Health Research, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Kettunen', 'Affiliation': 'Center for Life Course Health Research, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Holmes', 'Affiliation': 'Medical Research Council Population Health Research Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Clare Oliver', 'Initials': 'CO', 'LastName': 'Williams', 'Affiliation': 'MRC/BHF Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Boachie', 'Affiliation': 'Robertson Centre for Biostatistics, Boyd Orr Building, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Center for Life Course Health Research, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Männikkö', 'Affiliation': 'Northern Finland Birth Cohorts, Faculty of Medicine, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Sebert', 'Affiliation': 'Center for Life Course Health Research, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Walters', 'Affiliation': 'Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Kuang', 'Initials': 'K', 'LastName': 'Lin', 'Affiliation': 'Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Iona Y', 'Initials': 'IY', 'LastName': 'Millwood', 'Affiliation': 'Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Clarke', 'Affiliation': 'Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Chinese Academy of Medical Sciences, 9 Dongdan San Tiao, Beijing, China.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Rankin', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Welsh', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Delles', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, UK.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Trompet', 'Affiliation': 'Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Robertson Centre for Biostatistics, Boyd Orr Building, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Perola', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Veikko', 'Initials': 'V', 'LastName': 'Salomaa', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Marjo-Riitta', 'Initials': 'MR', 'LastName': 'Järvelin', 'Affiliation': 'Center for Life Course Health Research, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Zhengming', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Debbie A', 'Initials': 'DA', 'LastName': 'Lawlor', 'Affiliation': 'Medical Research Council Integrative Epidemiology Unit at the University of Bristol, Bristol, UK.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Ala-Korpela', 'Affiliation': 'Center for Life Course Health Research, University of Oulu, Oulu, Finland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Danesh', 'Affiliation': 'MRC/BHF Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Davey Smith', 'Affiliation': 'Medical Research Council Integrative Epidemiology Unit at the University of Bristol, Bristol, UK.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Butterworth', 'Affiliation': 'MRC/BHF Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Würtz', 'Affiliation': 'Diabetes and Obesity Research Program, University of Helsinki, Helsinki, Finland.'}]",Circulation,['10.1161/CIRCULATIONAHA.118.034942']
844,31505228,A Phase 3 Randomized Study of Remestemcel-L versus Placebo Added to Second-Line Therapy in Patients with Steroid-Refractory Acute Graft-versus-Host Disease.,"Uncontrolled studies have suggested that bone marrow-derived mesenchymal stem cells (MSCs) may be effective against acute graft-versus-host disease (aGVHD). We conducted a multicenter, randomized study to assess the efficacy of using ex vivo cultured adult human MSC (remestemcel-L) in addition to second-line therapy to treat steroid-refractory aGVHD (NCT00366145). In total, 260 patients, 6 months to 70 years of age, were enrolled from August 2006 to May 2009 and were randomized 2:1 to receive 8 intravenous infusions of remestemcel-L or placebo, given over 4 weeks, in addition to second-line therapy according to institutional standards. Four additional infusions over 4 weeks were indicated for patients with incomplete response at day 28. Randomization was stratified by aGVHD grade. Efficacy and safety were assessed through 180 days of follow-up, with the primary endpoint being durable complete response (DCR), defined as complete resolution of aGVHD symptoms for any period of at least 28 days after beginning treatment. Remestemcel-L did not meet the primary endpoint of greater DCR in the intent-to-treat population (35% versus 30%; P = 0.42). In post hoc analyses, patients with liver involvement who received at least 1 infusion of remestemcel-L had a higher DCR, and higher overall complete or partial response rate (OR) than those who received placebo (29% versus 5%; P = .047). Among high-risk patients (aGVHD grades C and D), remestemcel-L demonstrated significantly higher OR at day 28 than placebo (58% versus 37%; P = 0.03). Furthermore, pediatric patients had a higher OR with MSCs compared with placebo (64% versus 23%; P = .05). Similar rates of adverse events were observed between treatment groups. Remestemcel-L was safe and well tolerated. Results of this study did not demonstrate superior DCR compared with placebo when added to standard of care. The favorable clinical responses seen in some patient subsets may warrant further investigation.",2020,"Furthermore, pediatric patients had a higher OR with MSCs compared with placebo (64% versus 23%; P = .05).","['260 patients, 6 months to 70 years of age, were enrolled from August 2006 to May 2009', 'Patients with Steroid-Refractory Acute Graft-versus-Host Disease']","['placebo', 'ex vivo cultured adult human MSC (remestemcel-L', 'Remestemcel-L versus Placebo Added to Second-Line Therapy', 'intravenous infusions of remestemcel-L or placebo']","['overall complete or partial response rate (OR', 'adverse events', 'durable complete response (DCR), defined as complete resolution of aGVHD symptoms', 'Efficacy and safety', 'safe and well tolerated']","[{'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",260.0,0.32227,"Furthermore, pediatric patients had a higher OR with MSCs compared with placebo (64% versus 23%; P = .05).","[{'ForeName': 'Partow', 'Initials': 'P', 'LastName': 'Kebriaei', 'Affiliation': 'Department of Stem Cell and Cellular Therapy, University of Texas MD Anderson Cancer Center, Houston, Texas. Electronic address: pkebriae@mdanderson.org.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Hayes', 'Affiliation': 'Mesoblast, New York, New York.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Daly', 'Affiliation': 'Tom Baker Cancer Center, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Uberti', 'Affiliation': 'Barbara Ann Karmanos Cancer Institute, Detroit, Michigan.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Marks', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Soiffer', 'Affiliation': 'Dana-Farber Cancer Institute, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Edmund K', 'Initials': 'EK', 'LastName': 'Waller', 'Affiliation': 'Emory University Bone Marrow and Stem Cell Transplant Center, Atlanta, Georgia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Burke', 'Affiliation': 'Mesoblast, New York, New York.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Skerrett', 'Affiliation': 'Mesoblast, New York, New York.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Shpall', 'Affiliation': 'Department of Stem Cell and Cellular Therapy, University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Martin', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2019.08.029']
845,31974286,"Sodium Bicarbonate Supplementation and Urinary TGF- β 1 in Nonacidotic Diabetic Kidney Disease: A Randomized, Controlled Trial.","BACKGROUND AND OBJECTIVES


In early-phase studies of individuals with hypertensive CKD and normal serum total CO 2 , sodium bicarbonate reduced urinary TGF- β 1 levels and preserved kidney function. The effect of sodium bicarbonate on kidney fibrosis and injury markers in individuals with diabetic kidney disease and normal serum total CO 2  is unknown.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


We conducted a randomized, double-blinded, placebo-controlled study in 74 United States veterans with type 1 or 2 diabetes mellitus, eGFR of 15-89 ml/min per 1.73 m 2 , urinary albumin-to-creatinine ratio (UACR) ≥30 mg/g, and serum total CO 2  of 22-28 meq/L. Participants received oral sodium bicarbonate (0.5 meq/kg lean body wt per day;  n =35) or placebo ( n =39) for 6 months. The primary outcome was change in urinary TGF- β 1-to-creatinine from baseline to months 3 and 6. Secondary outcomes included changes in urinary kidney injury molecule-1 (KIM-1)-to-creatinine, fibronectin-to-creatinine, neutrophil gelatinase-associated lipocalin (NGAL)-to-creatinine, and UACR from baseline to months 3 and 6.
RESULTS


Key baseline characteristics were age 72±8 years, eGFR of 51±18 ml/min per 1.73 m 2 , and serum total CO 2  of 24±2 meq/L. Sodium bicarbonate treatment increased mean total CO 2  by 1.2 (95% confidence interval [95% CI], 0.3 to 2.1) meq/L, increased urinary pH by 0.6 (95% CI, 0.5 to 0.8), and decreased urinary ammonium excretion by 5 (95% CI, 0 to 11) meq/d and urinary titratable acid excretion by 11 (95% CI, 5 to 18) meq/d. Sodium bicarbonate did not significantly change urinary TGF- β 1/creatinine (difference in change, 13%, 95% CI, -10% to 40%; change within the sodium bicarbonate group, 8%, 95% CI, -10% to 28%; change within the placebo group, -4%, 95% CI, -19% to 13%). Similarly, no significant effect on KIM-1-to-creatinine (difference in change, -10%, 95% CI, -38% to 31%), fibronectin-to-creatinine (8%, 95% CI, -15% to 37%), NGAL-to-creatinine (-33%, 95% CI, -56% to 4%), or UACR (1%, 95% CI, -25% to 36%) was observed.
CONCLUSIONS


In nonacidotic diabetic kidney disease, sodium bicarbonate did not significantly reduce urinary TGF- β 1, KIM-1, fibronectin, NGAL, or UACR over 6 months.",2020,Sodium bicarbonate did not significantly change urinary,"['74 United States veterans with type 1 or 2 diabetes mellitus, eGFR of 15-89 ml/min per 1.73 m 2 , urinary albumin-to-creatinine ratio (UACR) ≥30', 'individuals with hypertensive CKD and normal serum total CO 2 ', 'Nonacidotic Diabetic Kidney Disease', 'individuals with diabetic kidney disease and normal serum total CO 2']","['sodium bicarbonate', 'Sodium Bicarbonate Supplementation and Urinary TGF', 'oral sodium bicarbonate', 'placebo', 'Sodium bicarbonate', 'TGF']","['urinary pH', 'fibronectin-to-creatinine', 'urinary ammonium excretion', 'KIM-1-to-creatinine', 'NGAL-to-creatinine', 'change urinary', 'urinary titratable acid excretion', 'UACR', 'kidney fibrosis and injury markers', 'changes in urinary kidney injury molecule-1 (KIM-1)-to-creatinine, fibronectin-to-creatinine, neutrophil gelatinase-associated lipocalin (NGAL)-to-creatinine, and UACR', 'urinary TGF- β 1, KIM-1, fibronectin, NGAL, or UACR', 'mean total CO 2', 'change in urinary TGF- β 1-to-creatinine']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0016055', 'cui_str': 'Opsonic alpha(2)SB Glycoprotein'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0002611', 'cui_str': 'Ammonium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0151650', 'cui_str': 'Renal fibrosis (disorder)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2681921', 'cui_str': 'Kidney injury molecule-1'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206528', 'cui_str': 'Gelatinases'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.452047,Sodium bicarbonate did not significantly change urinary,"[{'ForeName': 'Kalani L', 'Initials': 'KL', 'LastName': 'Raphael', 'Affiliation': 'Medicine Section, Veterans Affairs Salt Lake City Health Care System, Salt Lake City, Utah; and kalani.raphael@hsc.utah.edu.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'Department of Internal Medicine, University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Wei', 'Affiliation': 'Department of Internal Medicine, University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'Tristin', 'Initials': 'T', 'LastName': 'Bullshoe', 'Affiliation': 'Department of Internal Medicine, University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'Kunani', 'Initials': 'K', 'LastName': 'Tuttle', 'Affiliation': 'Department of Internal Medicine, University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Medicine Section, Veterans Affairs Salt Lake City Health Care System, Salt Lake City, Utah; and.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Beddhu', 'Affiliation': 'Medicine Section, Veterans Affairs Salt Lake City Health Care System, Salt Lake City, Utah; and.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.06600619']
846,30195661,"Efficacy of brief behavioral treatment for insomnia in older adults: examination of sleep, mood, and cognitive outcomes.","OBJECTIVE


The aim of the present study was to examine the effects of a brief behavioral intervention for insomnia (BBTi) on sleep parameters, mood, and cognitive functioning in older adults.
METHODS


Older adults (aged 65 years or more) underwent four weekly sessions of BBTi or self-monitoring control (SMC). Participants completed 14 days of sleep diaries and actigraphy measuring sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), sleep efficiency (SE), and sleep quality ratings at baseline, post-treatment, and three month follow-up. Participants also completed mood scales (Geriatric Depression Scale [GDS]; Beck Depression Inventory-II; and State Trait Anxiety Inventory) and neuropsychological testing (measuring global cognition, language, memory, attention and processing speed, and executive function) at the three timepoints.
RESULTS


Significant condition (BBTi vs. SMC) x time (baseline vs. post-treatment vs. follow-up) interactions revealed that BBTi improved relative to baseline in sleep diary-reported SOL, WASO, SE, and sleep quality, and these improvements were maintained at follow-up. SMC showed no change in these measures. A main effect of time showed that actigraphy-measured WASO improved from baseline for both BBTi and SMC at post-treatment. A main effect of time revealed that both BBTi and SMC patients endorsed fewer GDS symptoms relative to baseline at post-treatment and follow-up. We observed no change in performance on neuropsychological measures.
CONCLUSIONS


A four-week BBTi is an efficacious intervention for reducing insomnia symptoms in older adults. BBTi does not selectively improve mood or cognitive functioning. Future work should examine effects of BBTi on physiological measures of sleep architecture and day-to-day cognition.
CLINICAL TRIAL IDENTIFER


NCT02967185.",2018,A main effect of time revealed that both BBTi and SMC patients endorsed fewer GDS symptoms relative to baseline at post-treatment and follow-up.,"['Older adults (aged 65 years or more', 'older adults']","['BBTi or self-monitoring control (SMC', 'brief behavioral treatment', 'behavioral intervention for insomnia (BBTi']","['sleep parameters, mood, and cognitive functioning', 'sleep diaries and actigraphy measuring sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), sleep efficiency (SE), and sleep quality ratings', 'sleep diary-reported SOL, WASO, SE, and sleep quality', 'mood scales (Geriatric Depression Scale [GDS]; Beck Depression Inventory-II; and State Trait Anxiety Inventory) and neuropsychological testing (measuring global cognition, language, memory, attention and processing speed, and executive function', 'GDS symptoms', 'mood or cognitive functioning', 'insomnia symptoms', 'actigraphy-measured WASO']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0701413', 'cui_str': 'Sol'}, {'cui': 'C0222045'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]",,0.0485785,A main effect of time revealed that both BBTi and SMC patients endorsed fewer GDS symptoms relative to baseline at post-treatment and follow-up.,"[{'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'McCrae', 'Affiliation': 'Department of Psychiatry, University of Missouri-Columbia, Columbia, MO, USA. Electronic address: mccraec@health.missouri.edu.'}, {'ForeName': 'Ashley F', 'Initials': 'AF', 'LastName': 'Curtis', 'Affiliation': 'Department of Psychiatry, University of Missouri-Columbia, Columbia, MO, USA.'}, {'ForeName': 'Jacob M', 'Initials': 'JM', 'LastName': 'Williams', 'Affiliation': 'TIRR Memorial Hermann, Houston, TX, USA.'}, {'ForeName': 'Natalie D', 'Initials': 'ND', 'LastName': 'Dautovich', 'Affiliation': 'Psychology Department, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Joseph P H', 'Initials': 'JPH', 'LastName': 'McNamara', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Stripling', 'Affiliation': 'College of Psychology, Nova Southeastern University, Fort Lauderdale, FL, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Dzierzewski', 'Affiliation': 'Psychology Department, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Wai Sze', 'Initials': 'WS', 'LastName': 'Chan', 'Affiliation': 'Department of Psychiatry, Geisel School of Medicine, Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Berry', 'Affiliation': 'College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Karin J M', 'Initials': 'KJM', 'LastName': 'McCoy', 'Affiliation': 'Neuropsychology Service, South Texas Veterans Health Care System, San Antonio, TX, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Marsiske', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}]",Sleep medicine,['10.1016/j.sleep.2018.05.018']
847,32144133,Randomized Phase II Trial Evaluating Treatment with EGFR-TKI Associated with Antiestrogen in Women with Nonsquamous Advanced-Stage NSCLC: IFCT-1003 LADIE Trial.,"PURPOSE


The incidence of lung cancer has dramatically increased in women. Preclinical data have suggested that combining EGFR-tyrosine kinase inhibitor (TKI) with an antiestrogen may overcome resistance to EGFR-TKI.
PATIENTS AND METHODS


The IFCT-1003 LADIE trial was a 2 × 2 arms parallel open-label randomized phase II trial. EGFR-TKI-naïve postmenopausal women with advanced lung cancer were treated with gefitinib (G) versus gefitinib + fulvestrant (G+F) in the EGFR-mutated group (EGFR + ) or with erlotinib (E) versus erlotinib + fulvestrant (E+F) in the EGFR wild-type group (EGFR-WT). The primary objective was progression-free survival (PFS) at 3 and 9 months for EGFR-WT and EGFR +  patients.
RESULTS


Overall, 204 patients (gefitinib 104 and G+F 100) and 175 patients (erlotinib 87 and E+F 88) were enrolled in the EGFR +  and EGFR-WT cohorts. In the EGFR +  cohort, the primary endpoint was reached, with 58% of the G+F group patients being nonprogressive at 9 months. Adding fulvestrant to gefitinib was not associated with improved PFS (9.9 vs 9.4 months) or overall survival (OS; 22.1 vs 28.6 months). In the EGFR-WT cohort, the primary endpoint was also achieved (33.7% of the patients were nonprogressive at 3 months). Adding fulvestrant to erlotinib was not associated with improved outcome (PFS 1.8 vs 2.0 and OS 10.3 vs 7.3 months). No PFS difference was observed regarding estrogen receptor alpha expression. The tolerance was as expected with no treatment-related death.
CONCLUSIONS


Adding fulvestrant to EGFR-TKI is feasible, but not associated with prolonged PFS regardless of EGFR status. The lack of benefits while combining fulvestrant to EGFR-TKI does not support its future development in an unselected population.",2020,Adding F to G was not associated with improved PFS (9.9 vs 9.4 months) or OS (22.1 vs 28.6 months).,"['women with non-squamous advanced stage NSCLC', 'women', '204 patients and 175 patients were enrolled in the EGFR+ and EGFR-WT cohorts', 'EGFR-TKI-naïve post-menopausal women with advanced lung cancer']","['EGFR mutated group (EGFR+) or with erlotinib (E) vs. E + fulvestrant (E+F', 'gefitinib (G) vs. G + fulvestrant (G+F', 'G+F', 'EGFR-TKI associated with anti-estrogen']","['progression-free survival (PFS', 'PFS', 'Estrogen Receptor alpha expression']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C4524268', 'cui_str': 'Advanced lung cancer'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0014930', 'cui_str': 'Estrogen Antagonists'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0665341', 'cui_str': 'Estrogen Receptor alpha'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",204.0,0.0564342,Adding F to G was not associated with improved PFS (9.9 vs 9.4 months) or OS (22.1 vs 28.6 months).,"[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Mazieres', 'Affiliation': 'Service de Pneumologie, Hôpital Larrey, Centre Hospitalier Universitaire Toulouse, Toulouse, France. mazieres.j@chu-toulouse.fr.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Barlesi', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Rouquette', 'Affiliation': ""Service d'Anatomopathologie, Centre Hospitalier Universitaire Toulouse, Toulouse, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Molinier', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Besse', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Monnet', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Audigier-Valette', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Anne-Claire', 'Initials': 'AC', 'LastName': 'Toffart', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Patrick Aldo', 'Initials': 'PA', 'LastName': 'Renault', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Séverine', 'Initials': 'S', 'LastName': 'Fraboulet', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Hiret', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Mennecier', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Debieuvre', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Westeel', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Masson', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Madroszyk-Flandin', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Pichon', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Alexis B', 'Initials': 'AB', 'LastName': 'Cortot', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Amour', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Morin', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Zalcman', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Moro-Sibilot', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Pierre-Jean', 'Initials': 'PJ', 'LastName': 'Souquet', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3056']
848,30095158,Validation of the MCL35 gene expression proliferation assay in randomized trials of the European Mantle Cell Lymphoma Network.,"Mantle cell lymphoma (MCL) is still considered incurable and the course of the disease is highly variable. Established risk factors include the Mantle Cell Lymphoma International Prognostic Index (MIPI) and the quantification of the proliferation rate of the tumour cells, e.g. by Ki-67 immunohistochemistry. In this study, we aimed to validate the prognostic value of the gene expression-based MCL35 proliferation assay in patient cohorts from randomized trials of the European Mantle Cell Lymphoma Network. Using this assay, we analysed the gene expression proliferation signature in routine diagnostic lymph node specimens from MCL Younger and MCL Elderly trial patients, and the calculated MCL35 score was used to assign MCL patients to low (61%), standard (27%) or high (12%) risk groups with significantly different outcomes. We confirm here in our prospective clinical trial cohort of MCL patients, that the MCL35 assay is strongly prognostic, providing additional information to the Ki-67 index and the MIPI. Thus, this robust assay may assist in making treatment decisions or in devising risk-adapted prospective clinical trials in the future.",2019,"Established risk factors include the Mantle Cell Lymphoma International Prognostic Index (MIPI) and the quantification of the proliferation rate of the tumour cells, e.g. by Ki-67 immunohistochemistry.","['European Mantle Cell Lymphoma Network', 'patient cohorts from randomized trials of the European Mantle Cell Lymphoma Network', 'routine diagnostic lymph node specimens from MCL Younger and MCL Elderly trial patients']","['gene expression-based MCL35 proliferation assay', 'MCL']",[],"[{'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0334634', 'cui_str': 'Lymphoma, Small-Cell, Centrocytic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}]",[],,0.0313025,"Established risk factors include the Mantle Cell Lymphoma International Prognostic Index (MIPI) and the quantification of the proliferation rate of the tumour cells, e.g. by Ki-67 immunohistochemistry.","[{'ForeName': 'Hilka', 'Initials': 'H', 'LastName': 'Rauert-Wunderlich', 'Affiliation': 'Institute of Pathology, University of Würzburg and Comprehensive Cancer Centre (CCC) Mainfranken, Würzburg, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Mottok', 'Affiliation': 'Institute of Pathology, University of Würzburg and Comprehensive Cancer Centre (CCC) Mainfranken, Würzburg, Germany.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Scott', 'Affiliation': 'Centre for Lymphoid Cancer, British Columbia Cancer Agency, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Rimsza', 'Affiliation': 'Laboratory Medicine and Pathology, Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'German', 'Initials': 'G', 'LastName': 'Ott', 'Affiliation': 'Department of Clinical Pathology, Robert-Bosch-Krankenhaus, Stuttgart, Germany.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Klapper', 'Affiliation': 'Department of Pathology, Haematopathology Section\xa0and Lymph Node Registry, University of Kiel, Kiel, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Unterhalt', 'Affiliation': 'Department of Medicine III, University Hospital of the Ludwig Maximilians University Munich, Munich, Germany.'}, {'ForeName': 'Hanneke C', 'Initials': 'HC', 'LastName': 'Kluin-Nelemans', 'Affiliation': 'Department of Haematology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Hermine', 'Affiliation': 'Department of Haematology, Necker Hospital, Public Assistance - Hospital of Paris, University Paris Descartes, Paris, France.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Hartmann', 'Affiliation': 'Dr. Senckenberg Institute of Pathology, Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Thorns', 'Affiliation': 'Institute of Pathology, Marienkrankenhaus, Hamburg, Germany.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Rymkiewicz', 'Affiliation': 'Department of Pathology and Laboratory Diagnostics, Maria Sklodowska-Curie Institute-Oncology Centre, Warsaw, Poland.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Holte', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dreyling', 'Affiliation': 'Department of Medicine III, University Hospital of the Ludwig Maximilians University Munich, Munich, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hoster', 'Affiliation': 'Department of Medicine III, University Hospital of the Ludwig Maximilians University Munich, Munich, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Rosenwald', 'Affiliation': 'Institute of Pathology, University of Würzburg and Comprehensive Cancer Centre (CCC) Mainfranken, Würzburg, Germany.'}]",British journal of haematology,['10.1111/bjh.15519']
849,29808473,The independent effects of hypovolaemia and pulmonary vasoconstriction on ventricular function and exercise capacity during acclimatisation to 3800 m.,"KEY POINTS


We sought to determine the isolated and combined influence of hypovolaemia and hypoxic pulmonary vasoconstriction on the decrease in left ventricular (LV) function and maximal exercise capacity observed under hypobaric hypoxia. We performed echocardiography and maximal exercise tests at sea level (344 m), and following 5-10 days at the Barcroft Laboratory (3800 m; White Mountain, California) with and without (i) plasma volume expansion to sea level values and (ii) administration of the pulmonary vasodilatator sildenafil in a double-blinded and placebo-controlled trial. The high altitude-induced reduction in LV filling and ejection was abolished by plasma volume expansion but to a lesser extent by sildenafil administration; however, neither intervention had a positive effect on maximal exercise capacity. Both hypovolaemia and hypoxic pulmonary vasoconstriction play a role in the reduction of LV filling at 3800 m, but the increase in LV filling does not influence exercise capacity at this moderate altitude.
ABSTRACT


We aimed to determine the isolated and combined contribution of hypovolaemia and hypoxic pulmonary vasoconstriction in limiting left ventricular (LV) function and exercise capacity under chronic hypoxaemia at high altitude. In a double-blinded, randomised and placebo-controlled design, 12 healthy participants underwent echocardiography at rest and during submaximal exercise before completing a maximal test to exhaustion at sea level (SL; 344 m) and after 5-10 days at 3800 m. Plasma volume was normalised to SL values, and hypoxic pulmonary vasoconstriction was reversed by administration of sildenafil (50 mg) to create four unique experimental conditions that were compared with SL values: high altitude (HA), Plasma Volume Expansion (HA-PVX), Sildenafil (HA-SIL) and Plasma Volume Expansion with Sildenafil (HA-PVX-SIL). High altitude exposure reduced plasma volume by 11% (P < 0.01) and increased pulmonary artery systolic pressure (19.6 ± 4.3 vs. 26.0 ± 5.4, P < 0.001); these differences were abolished by PVX and SIL respectively. LV end-diastolic volume (EDV) and stroke volume (SV) were decreased upon ascent to high altitude, but were comparable to sea level in the HA-PVX trial. LV EDV and SV were also elevated in the HA-SIL and HA-PVX-SIL trials compared to HA, but to a lesser extent. Neither PVX nor SIL had a significant effect on the LV EDV and SV response to exercise, or the maximal oxygen consumption or peak power output. In summary, at 3800 m both hypovolaemia and hypoxic pulmonary vasoconstriction contribute to the decrease in LV filling, but restoring LV filling does not confer an improvement in maximal exercise performance.",2019,"LV end-diastolic volume (EDV) and stroke volume (SV) were decreased upon ascent to high altitude, but were comparable to sea level in the HA-PVX trial.","['12 healthy participants underwent', 'acclimatisation to 3800\xa0m', 'chronic hypoxaemia at high altitude']","['placebo', 'Sildenafil', 'echocardiography at rest and during submaximal exercise', 'sildenafil', 'echocardiography and maximal exercise tests at sea level (344\xa0m), and following 5-10\xa0days at the Barcroft Laboratory (3800\xa0m; White Mountain, California) with and without (i) plasma volume expansion to sea level values and (ii) administration of the pulmonary vasodilatator sildenafil', 'hypovolaemia and hypoxic pulmonary vasoconstriction', 'hypovolaemia and pulmonary vasoconstriction']","['left ventricular (LV) function and maximal exercise capacity', 'plasma volume', 'pulmonary artery systolic pressure', 'ventricular function and exercise capacity', 'SL values, and hypoxic pulmonary vasoconstriction', 'altitude (HA), Plasma Volume Expansion (HA-PVX), Sildenafil (HA-SIL) and Plasma Volume Expansion', 'LV end-diastolic volume (EDV) and stroke volume (SV', 'LV EDV and SV response to exercise, or the maximal oxygen consumption or peak power output', 'maximal exercise performance', 'LV EDV and SV', 'maximal exercise capacity', 'Plasma volume']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0238617', 'cui_str': 'High altitude (physical force)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0036493', 'cui_str': 'Sea (environment)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0442533', 'cui_str': 'Mountain (environment)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0032127', 'cui_str': 'Blood Plasma Volume'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0546884', 'cui_str': 'Hypovolemia'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C1456863', 'cui_str': 'Vasoconstriction'}]","[{'cui': 'C0080309', 'cui_str': 'Ventricular Function'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0032127', 'cui_str': 'Blood Plasma Volume'}, {'cui': 'C0428643', 'cui_str': 'Pulmonary artery systolic pressure (observable entity)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C1456863', 'cui_str': 'Vasoconstriction'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0333873', 'cui_str': 'Squamous intraepithelial lesion'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}]",12.0,0.082604,"LV end-diastolic volume (EDV) and stroke volume (SV) were decreased upon ascent to high altitude, but were comparable to sea level in the HA-PVX trial.","[{'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Stembridge', 'Affiliation': 'Cardiff Centre for Exercise and Health, Cardiff Metropolitan University, Cardiff, UK.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Ainslie', 'Affiliation': 'Centre for Heart Lung and Vascular Health, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Boulet', 'Affiliation': 'Centre for Heart Lung and Vascular Health, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Anholm', 'Affiliation': 'VA Loma Linda Healthcare System and Loma Linda University School of Medicine, Loma Linda, CA, USA.'}, {'ForeName': 'Prajan', 'Initials': 'P', 'LastName': 'Subedi', 'Affiliation': 'VA Loma Linda Healthcare System and Loma Linda University School of Medicine, Loma Linda, CA, USA.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Tymko', 'Affiliation': 'Centre for Heart Lung and Vascular Health, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Willie', 'Affiliation': 'Centre for Heart Lung and Vascular Health, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Stephen-Mark', 'Initials': 'SM', 'LastName': 'Cooper', 'Affiliation': 'Cardiff Centre for Exercise and Health, Cardiff Metropolitan University, Cardiff, UK.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Shave', 'Affiliation': 'Cardiff Centre for Exercise and Health, Cardiff Metropolitan University, Cardiff, UK.'}]",The Journal of physiology,['10.1113/JP275278']
850,29914843,Diagnostic accuracy of magnetic resonance enterography and small bowel ultrasound for the extent and activity of newly diagnosed and relapsed Crohn's disease (METRIC): a multicentre trial.,"BACKGROUND


Magnetic resonance enterography (MRE) and ultrasound are used to image Crohn's disease, but their comparative accuracy for assessing disease extent and activity is not known with certainty. Therefore, we did a multicentre trial to address this issue.
METHODS


We recruited patients from eight UK hospitals. Eligible patients were 16 years or older, with newly diagnosed Crohn's disease or with established disease and suspected relapse. Consecutive patients had MRE and ultrasound in addition to standard investigations. Discrepancy between MRE and ultrasound for the presence of small bowel disease triggered an additional investigation, if not already available. The primary outcome was difference in per-patient sensitivity for small bowel disease extent (correct identification and segmental localisation) against a construct reference standard (panel diagnosis). This trial is registered with the International Standard Randomised Controlled Trial, number ISRCTN03982913, and has been completed.
FINDINGS


284 patients completed the trial (133 in the newly diagnosed group, 151 in the relapse group). Based on the reference standard, 233 (82%) patients had small bowel Crohn's disease. The sensitivity of MRE for small bowel disease extent (80% [95% CI 72-86]) and presence (97% [91-99]) were significantly greater than that of ultrasound (70% [62-78] for disease extent, 92% [84-96] for disease presence); a 10% (95% CI 1-18; p=0·027) difference for extent, and 5% (1-9; p=0·025) difference for presence. The specificity of MRE for small bowel disease extent (95% [85-98]) was significantly greater than that of ultrasound (81% [64-91]); a difference of 14% (1-27; p=0·039). The specificity for small bowel disease presence was 96% (95% CI 86-99) with MRE and 84% (65-94) with ultrasound (difference 12% [0-25]; p=0·054). There were no serious adverse events.
INTERPRETATION


Both MRE and ultrasound have high sensitivity for detecting small bowel disease presence and both are valid first-line investigations, and viable alternatives to ileocolonoscopy. However, in a national health service setting, MRE is generally the preferred radiological investigation when available because its sensitivity and specificity exceed ultrasound significantly.
FUNDING


National Institute of Health and Research Health Technology Assessment.",2018,The specificity of MRE for small bowel disease extent (95% [85-98]) was significantly greater than that of ultrasound (81% [64-91]); a difference of 14% (1-27; p=0·039).,"[""233 (82%) patients had small bowel Crohn's disease"", 'Consecutive patients had MRE and ultrasound in addition to standard investigations', ""Eligible patients were 16 years or older, with newly diagnosed Crohn's disease or with established disease and suspected relapse"", 'recruited patients from eight UK hospitals', ""newly diagnosed and relapsed Crohn's disease (METRIC"", '284 patients completed the trial (133 in the newly diagnosed group, 151 in the relapse group']","['magnetic resonance enterography and small bowel ultrasound', 'Magnetic resonance enterography (MRE']","['specificity for small bowel disease presence', 'sensitivity of MRE for small bowel disease extent', 'per-patient sensitivity for small bowel disease extent (correct identification and segmental localisation) against a construct reference standard (panel diagnosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C4274338', 'cui_str': 'Magnetic resonance enterography (procedure)'}, {'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0205122', 'cui_str': 'Segmental (qualifier value)'}, {'cui': 'C0475264', 'cui_str': 'Localization - action (qualifier value)'}, {'cui': 'C0034925', 'cui_str': 'Reference Standards'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",284.0,0.272938,The specificity of MRE for small bowel disease extent (95% [85-98]) was significantly greater than that of ultrasound (81% [64-91]); a difference of 14% (1-27; p=0·039).,"[{'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Taylor', 'Affiliation': 'Centre for Medical Imaging, University College London (UCL), London, UK. Electronic address: stuart.taylor1@nhs.net.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Mallett', 'Affiliation': 'Institute of Applied Health Research, National Institute of Health and Research Birmingham Biomedical Research Centre, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Gauraang', 'Initials': 'G', 'LastName': 'Bhatnagar', 'Affiliation': 'Centre for Medical Imaging, University College London (UCL), London, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Baldwin-Cleland', 'Affiliation': ""Intestinal Imaging Centre, St Mark's Hospital, London North West University Healthcare (LNWUH) National Health Service (NHS) Trust, Harrow, UK.""}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Bloom', 'Affiliation': 'Department of Gastroenterology, University College Hospital, London, UK.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': ""Intestinal Imaging Centre, St Mark's Hospital, London North West University Healthcare (LNWUH) National Health Service (NHS) Trust, Harrow, UK.""}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Hamlin', 'Affiliation': ""Department of Gastroenterology, St James's University Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, UK.""}, {'ForeName': 'Ailsa L', 'Initials': 'AL', 'LastName': 'Hart', 'Affiliation': ""Inflammatory Bowel Disease Unit, St Mark's Hospital, LNWUH NHS Trust, Harrow, UK.""}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Higginson', 'Affiliation': 'Department of Radiology, Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Jacobs', 'Affiliation': 'Centre for Medical Imaging, UCL, London, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'McCartney', 'Affiliation': 'Department of Gastroenterology, University College Hospital, London, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Miles', 'Affiliation': 'Department of Psychological Sciences, Birkbeck University of London, London, UK.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Murray', 'Affiliation': 'Department of Gastroenterology and Endoscopy, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Plumb', 'Affiliation': 'Centre for Medical Imaging, University College London (UCL), London, UK.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Pollok', 'Affiliation': ""Department of Gastroenterology, St George's Hospital, London, UK.""}, {'ForeName': 'Shonit', 'Initials': 'S', 'LastName': 'Punwani', 'Affiliation': 'Centre for Medical Imaging, University College London (UCL), London, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Quinn', 'Affiliation': 'Institute of Applied Health Research, National Institute of Health and Research Birmingham Biomedical Research Centre, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Rodriguez-Justo', 'Affiliation': 'Department of Histopathology, University College Hospital, London, UK.'}, {'ForeName': 'Zainib', 'Initials': 'Z', 'LastName': 'Shabir', 'Affiliation': 'Comprehensive Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, Holborn, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Slater', 'Affiliation': 'Department of Radiology, Oxford University Hospitals NHS Trust, Oxford, UK.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Tolan', 'Affiliation': ""Department of Radiology, St James's University Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, UK.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Travis', 'Affiliation': 'Translational Gastroenterology Unit, Oxford University Hospitals, Oxford, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Windsor', 'Affiliation': 'Department of Surgery, University College Hospital, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wylie', 'Affiliation': 'Department of Radiology, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Zealley', 'Affiliation': 'Department of Radiology, Ninewells Hospital, Dundee, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Halligan', 'Affiliation': 'Centre for Medical Imaging, University College London (UCL), London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(18)30161-4']
851,32406553,Alcohol Cue-Induced Ventral Striatum Activity Predicts Subsequent Alcohol Self-Administration.,"BACKGROUND


Human laboratory paradigms are a pillar in medication development for alcohol use disorders (AUD). Neuroimaging paradigms, in which individuals are exposed to cues that elicit neural correlates of alcohol craving (e.g., mesocorticolimbic activation), are increasingly utilized to test the effects of AUD medications. Elucidation of the translational effects of these neuroimaging paradigms on human laboratory paradigms, such as self-administration, is warranted. The current study is a secondary analysis examining whether alcohol cue-induced activation in the ventral striatum is predictive of subsequent alcohol self-administration in the laboratory.
METHODS


Non-treatment-seeking heavy drinkers of East Asian descent (n = 41) completed a randomized, placebo-controlled, double-blind, crossover experiment on the effects of naltrexone on neuroimaging and human laboratory paradigms. Participants completed 5 days of study medication (or placebo); on day 4, they completed a neuroimaging alcohol taste cue-reactivity task. On the following day (day 5), participants completed a 60-minute alcohol self-administration paradigm.
RESULTS


Multilevel Cox regressions indicated a significant effect of taste cue-elicited ventral striatum activation on latency to first drink, Wald χ 2   = 2.88, p = 0.05, such that those with higher ventral striatum activation exhibited shorter latencies to consume their first drink. Similarly, ventral striatum activation was positively associated with total number of drinks consumed, F(1, 38) = 5.90, p = 0.02. These effects were significant after controlling for alcohol use severity, OPRM1 genotype, and medication. Other potential regions of interest (anterior cingulate, thalamus) were not predictive of self-administration outcomes.
CONCLUSIONS


Neuroimaging alcohol taste cue paradigms may be predictive of laboratory paradigms such as self-administration. Elucidation of the relationships among different paradigms will inform how these paradigms may be used synergistically in experimental medicine and medication development.",2020,"Other potential regions of interest (anterior cingulate, thalamus) were not predictive of self-administration outcomes.
",['Non-treatment-seeking heavy drinkers of East Asian descent (n\xa0=\xa041'],"['naltrexone', 'placebo']","['taste cue-elicited ventral striatum activation', 'ventral striatum activation']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0205386', 'cui_str': 'Descending'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0750950', 'cui_str': 'Ventral Striatum'}]",41.0,0.0517698,"Other potential regions of interest (anterior cingulate, thalamus) were not predictive of self-administration outcomes.
","[{'ForeName': 'Aaron C', 'Initials': 'AC', 'LastName': 'Lim', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'ReJoyce', 'Initials': 'R', 'LastName': 'Green', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Grodin', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Venegas', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'Lindsay R', 'Initials': 'LR', 'LastName': 'Meredith', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'Suzanna', 'Initials': 'S', 'LastName': 'Donato', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Burnette', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'Lara A', 'Initials': 'LA', 'LastName': 'Ray', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14342']
852,31982328,Psychoneuroendocrinoimmunology-based meditation (PNEIMED) training reduces salivary cortisol under basal and stressful conditions in healthy university students: Results of a randomized controlled study.,"BACKGROUND


Meditation represents an effective and safe practice to lower distress and promote well-being. PsychoNeuroEndocrinoImmunology-based Meditation (PNEIMED) is a validated method that can reduce stress-related symptoms and salivary cortisol secretion. To date, few randomised controlled trials (RCTs) have assessed cortisol levels through salivary samples, collected both in the morning phase and during acute mental stress elicitation, in healthy young subjects following brief meditation training.
AIM


The present study aims to investigate, in healthy young undergraduate students, the effects of a brief PNEIMED training course on HPA axis by measuring salivary cortisol levels.
METHODS


Forty students attending the Faculty of Psychology, without comorbidities and previous experience of meditation, were enrolled in the study. Twenty subjects were randomly assigned to 30 h of PNEIMED training (intervention group, IG), and twenty subjects were randomly assigned to 30 h of academic lessons (control group, CG). Salivary cortisol measures included basal morning (t0 = baseline time, collected 30 min after waking) and under stress-eliciting task values. Cortisol measurement under the stress-eliciting task was provided through the Subtraction Stress Task (SST) at scheduled time intervals (t1 = 5 min pre-SST, t2 = 10 min post-SST, t3 = 30 min = post-SST). Salivary cortisol was measured among all subjects (IG + CG) at the beginning (pre-test) and at the end (post-test, four days later) of the study.
RESULTS


ANOVA between-group analysis of basal diurnal salivary cortisol showed a significant hormone deflection in the IG at the end of the PNEIMED course (post-test) when compared to the CG (IG post-test 5.64 ± 4.2 vs CG post-test 9.44 ± 4.9; F 1,38  = 6.838; p = 0.013). RM-ANOVA within-group analysis for the IG also showed that time and condition effects were statistically significant, with Ftime = 5.438; p = 0.002 and Fcondition = 10.478; p = 0.004, respectively. The IG group presented a significant reduction in basal morning cortisol at the end of the PNEIMED course (post-test) compared to the salivary concentration at baseline (pre-test) (IG pre-test 9.42 ± 6.0 vs IG post-test 5.64 ± 4.2; F 1,38  8,354; p = 0.009). RM-ANOVA for the control group showed only the main effect of time (F 1,38  = 40.348; p < 0.001). Regarding cortisol measures under the SST-stress eliciting task, ANOVA between-groups analysis showed higher cortisol levels in the IG than in the CG before the PNEIMED course, with significant differences between groups at time t2 and time t3. After the PNEIMED course, the cortisol levels in the IG had decreased, although the differences between groups were not significant. Interestingly, ANOVA within-groups analysis showed that in the IG, the cortisol levels post-test (after the PNEIMED course) were lower than at pre-test (before the PNEIMED course), showing a significant difference of cortisol salivary concentration between conditions at t3 (F = 5.326; p = 0.032). In the control group, the post-hoc analyses for pairwise comparisons between conditions (pre-test vs post-test) did not show significant differences.
CONCLUSION


Although the low number of subjects enrolled in the study does not allow for definitive conclusions to be drawn, the present findings confirmed the capability of the PNEIMED method to lower stress hormone secretion both at baseline and under acute mental stimulation in a group of young naïve practitioners and make a contribution to the existing literature by increasing the number of published RCTs about the topic.",2020,"RM-ANOVA for the control group showed only the main effect of time (F 1,38  = 40.348; p < 0.001).","['healthy university students', 'Forty students attending the Faculty of Psychology, without comorbidities and previous experience of meditation, were enrolled in the study', 'healthy young subjects', 'healthy young undergraduate students', 'Twenty subjects']","['PsychoNeuroEndocrinoImmunology-based Meditation (PNEIMED', 'PNEIMED training (intervention group, IG', 'brief meditation training', 'Psychoneuroendocrinoimmunology-based meditation (PNEIMED) training', 'academic lessons (control group, CG']","['Salivary cortisol measures included basal morning (t0\xa0= baseline time, collected 30\xa0min after waking) and under stress-eliciting task values', 'salivary concentration', 'basal morning cortisol', 'basal diurnal salivary cortisol', 'cortisol levels', 'Salivary cortisol', 'hormone deflection', 'salivary cortisol under basal and stressful conditions', 'time and condition effects', 'cortisol salivary concentration']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0150277'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150277'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",20.0,0.0431604,"RM-ANOVA for the control group showed only the main effect of time (F 1,38  = 40.348; p < 0.001).","[{'ForeName': 'Anna Giulia', 'Initials': 'AG', 'LastName': 'Bottaccioli', 'Affiliation': 'Faculty of Psychology, University ""Vita-Salute San Raffaele"", Milan, Italy; Italian Society of Psycho Neuro Endocrino Immunology (SIPNEI), Italy. Electronic address: annagiulia.bottaccioli@gmail.com.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bottaccioli', 'Affiliation': ""Italian Society of Psycho Neuro Endocrino Immunology (SIPNEI), Italy; Department of Clinical Medicine, Public Health, Life Sciences and the Environment, University of L'Aquila, Italy.""}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Carosella', 'Affiliation': ""Italian Society of Psycho Neuro Endocrino Immunology (SIPNEI), Italy; Department of Clinical Medicine, Public Health, Life Sciences and the Environment, University of L'Aquila, Italy.""}, {'ForeName': 'Vincenza', 'Initials': 'V', 'LastName': 'Cofini', 'Affiliation': ""Department of Clinical Medicine, Public Health, Life Sciences and the Environment, University of L'Aquila, Italy.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Muzi', 'Affiliation': ""Department of Clinical Medicine, Public Health, Life Sciences and the Environment, University of L'Aquila, Italy.""}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Bologna', 'Affiliation': ""Italian Society of Psycho Neuro Endocrino Immunology (SIPNEI), Italy; Department of Clinical Medicine, Public Health, Life Sciences and the Environment, University of L'Aquila, Italy.""}]","Explore (New York, N.Y.)",['10.1016/j.explore.2019.10.006']
853,31981557,Effect of facility-based HIV self-testing on uptake of testing among outpatients in Malawi: a cluster-randomised trial.,"BACKGROUND


HIV self-testing increases testing uptake in sub-Saharan Africa but scale-up is challenging because of resource constraints. We evaluated an HIV self-testing intervention integrated into high-burden outpatient departments in Malawi.
METHODS


In this cluster-randomised trial, we recruited participants aged 15 years or older from 15 outpatient departments at high-burden health facilities (including health centres, mission hospitals, and district hospitals) in central and southern Malawi. The trial was clustered at the health facility level. We used constrained randomisation to allocate each cluster (1:1:1) to one of the following groups: standard provider-initiated testing and counselling with no intervention (provider offered during consultations), optimised provider-initiated testing and counselling (with additional provider training and morning HIV testing), and facility-based HIV self-testing (Oraquick HIV self-test, group demonstration and distribution, and private spaces for interpretation and counselling). The primary outcome was the proportion of outpatients tested for HIV on the day of enrolment, measured through exit surveys with a sample of outpatients. Analyses were on an intention-to-treat basis. The trial is registered with ClinicalTrials.gov, NCT03271307, and Pan African Clinical Trials, PACTR201711002697316.
FINDINGS


Between Sept 12, 2017, and Feb 23, 2018, 5885 outpatients completed an exit survey-2097 in the HIV self-testing group, 1951 in the standard provider-initiated testing and counselling group, and 1837 in the optimised provider-initiated testing and counselling group. 1063 (51%) of 2097 patients in the HIV self-testing group had HIV testing on the same day as enrolment, compared with 248 (13%) of 1951 in the standard provider-initiated testing and counselling group and 261 (14%) of 1837 in the optimised provider-initiated testing and counselling group. The odds of same-day HIV testing were significantly higher in the facility-based HIV self-testing group compared with either standard provider-initiated testing and counselling (adjusted odds ratio 8·52, 95% CI 3·98-18·24) or optimised provider-initiated testing and counselling (6·29, 2·96-13·38). Around 4% of those tested in the standard provider-initiated testing and counselling and optimised provider-initiated testing and counselling groups felt coerced to test, and around 1% felt coerced to share test results. No coercion was reported in the facility-based HIV self-testing group.
INTERPRETATION


Facility-based HIV self-testing increased HIV testing among outpatients in Malawi, with a minimal risk of adverse events. Facility-based HIV self-testing should be considered for scale-up in settings with a high unmet need for HIV testing.
FUNDING


United States Agency for International Development.",2020,"The odds of same-day HIV testing were significantly higher in the facility-based HIV self-testing group compared with either standard provider-initiated testing and counselling (adjusted odds ratio 8·52, 95% CI 3·98-18·24) or optimised provider-initiated testing and counselling (6·29, 2·96-13·38).","['outpatients in Malawi, with a minimal risk of adverse events', 'participants aged 15 years or older from 15 outpatient departments at high-burden health facilities (including health centres, mission hospitals, and district hospitals) in central and southern Malawi', '5885 outpatients completed an exit survey-2097 in the HIV self-testing group, 1951 in the standard provider-initiated testing and counselling group, and 1837 in the optimised provider-initiated testing and counselling group', '1063 (51%) of 2097 patients in the HIV self-testing group had HIV testing on the same day as enrolment, compared with 248 (13%) of 1951 in the standard provider-initiated testing and counselling group and 261 (14%) of 1837 in the optimised provider-initiated testing and counselling group', 'outpatients in Malawi', 'high-burden outpatient departments in Malawi']","['facility-based HIV self-testing', 'standard provider-initiated testing and counselling with no intervention (provider offered during consultations), optimised provider-initiated testing and counselling (with additional provider training and morning HIV testing), and facility-based HIV self-testing (Oraquick HIV self-test, group demonstration and distribution, and private spaces for interpretation and counselling']",['proportion of outpatients tested for HIV'],"[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0026219', 'cui_str': 'Missions'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0020006', 'cui_str': 'Hospitals, District'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0337094', 'cui_str': 'Exit (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1321876', 'cui_str': 'Human immunodeficiency virus test (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0459471', 'cui_str': 'Interpretation (attribute)'}]","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",5885.0,0.0574598,"The odds of same-day HIV testing were significantly higher in the facility-based HIV self-testing group compared with either standard provider-initiated testing and counselling (adjusted odds ratio 8·52, 95% CI 3·98-18·24) or optimised provider-initiated testing and counselling (6·29, 2·96-13·38).","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Dovel', 'Affiliation': 'Division of Infectious Diseases, University of California Los Angeles, Los Angeles, CA, USA; Partners in Hope, Lilongwe, Malawi. Electronic address: kdovel@mednet.ucla.edu.'}, {'ForeName': 'Frackson', 'Initials': 'F', 'LastName': 'Shaba', 'Affiliation': 'Partners in Hope, Lilongwe, Malawi.'}, {'ForeName': 'O Agatha', 'Initials': 'OA', 'LastName': 'Offorjebe', 'Affiliation': 'Department of Medicine and David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA; School of Medicine, Charles R Drew University of Medicine and Science, Los Angeles, CA, USA.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Balakasi', 'Affiliation': 'Partners in Hope, Lilongwe, Malawi.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Nyirenda', 'Affiliation': 'Partners in Hope, Lilongwe, Malawi.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Phiri', 'Affiliation': 'Partners in Hope, Lilongwe, Malawi.'}, {'ForeName': 'Sundeep K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': 'Division of Infectious Diseases, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Wong', 'Affiliation': 'USAID Global Health Bureau, Washington, DC, USA.'}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Brooke E', 'Initials': 'BE', 'LastName': 'Nichols', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Global Health, School of Public Health, Boston University, Boston, MA, USA.'}, {'ForeName': 'Refiloe', 'Initials': 'R', 'LastName': 'Cele', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lungu', 'Affiliation': 'Partners in Hope, Lilongwe, Malawi.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Masina', 'Affiliation': 'Malawi Ministry of Health, HIV/AIDS Unit, Lilongwe, Malawi.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Coates', 'Affiliation': 'Division of Infectious Diseases, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Risa M', 'Initials': 'RM', 'LastName': 'Hoffman', 'Affiliation': 'Division of Infectious Diseases, University of California Los Angeles, Los Angeles, CA, USA.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30534-0']
854,32406431,Adjunctive vitamin A and D during pulmonary tuberculosis treatment: a randomized controlled trial with a 2 × 2 factorial design.,"BACKGROUND AND OBJECTIVE


Vitamin A and D have immunoregulatory effects and may improve the response to pulmonary tuberculosis treatment. The interaction of vitamin A and D on pulmonary tuberculosis treatment has not been studied. The objective is to investigate the effects of adjunctive supplementation of vitamin A, D and their interaction on the outcome of pulmonary tuberculosis treatment, primarily time to sputum smear conversion.
METHODS


We conducted a randomized controlled trial with a 2 × 2 factorial design in Qingdao, China. Eight hundred patients were enrolled to receive standard pulmonary tuberculosis therapy alone (control), or together with vitamin A (2000 IU d-1), or vitamin D (400 IU d-1) or a combination of vitamin A (2000 IU d-1) and D (400 IU d-1) during the intensive-phase of pulmonary tuberculosis treatment.
RESULTS


761 patients were included in the tuberculosis symptom analysis; 521 patients with positive baseline sputum smear results were included in the sputum smear analysis. The allocation to vitamin A or D did not significantly influence the time to sputum smear conversion [vitamin A: adjusted hazard ratio: 1.021, 95% CI: (0.821, 1.271); vitamin D: adjusted hazard ratio: 0.949, 95% CI: (0.760, 1.185)]. No significant interaction was observed between vitamin A and D supplementation (p = 0.660). Vitamin D supplementation significantly relieved the tuberculosis symptoms as indicated by decreased TBscore [mean difference: -0.2, 95% CI: (-0.4, 0)] in week 2 to 4.
CONCLUSIONS


Adjunctive supplementation of vitamin A and/or D did not improve the time to smear conversion in pulmonary tuberculosis patients. However vitamin D supplementation significantly improved tuberculosis symptoms during the first month of pulmonary tuberculosis treatment.",2020,"Vitamin D supplementation significantly relieved the tuberculosis symptoms as indicated by decreased TBscore [mean difference: -0.2, 95% CI: (-0.4, 0)] in week 2 to 4.
","['761 patients were included in the tuberculosis symptom analysis; 521 patients with positive baseline sputum smear results were included in the sputum smear analysis', 'pulmonary tuberculosis patients', 'Eight hundred patients were enrolled to receive', '2 × 2 factorial design in Qingdao, China']","['Vitamin D supplementation', 'standard pulmonary tuberculosis therapy alone (control), or together with vitamin A (2000 IU d-1), or vitamin D (400 IU d-1) or a combination of vitamin A', 'vitamin A', 'Adjunctive vitamin A and D', 'vitamin D supplementation']","['time to smear conversion', 'tuberculosis symptoms', 'time to sputum smear conversion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3653679', 'cui_str': 'Combinations of vitamins'}, {'cui': 'C0310589', 'cui_str': 'Vitamin A- and vitamin D-containing product'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}]",800.0,0.539665,"Vitamin D supplementation significantly relieved the tuberculosis symptoms as indicated by decreased TBscore [mean difference: -0.2, 95% CI: (-0.4, 0)] in week 2 to 4.
","[{'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Nutrition and Health, School of Public Health, Qingdao University, Qingdao, Shandong 266021, China. magfood@qdu.edu.cn.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xiong', 'Affiliation': 'Institute of Nutrition and Health, School of Public Health, Qingdao University, Qingdao, Shandong 266021, China. magfood@qdu.edu.cn.'}, {'ForeName': 'Qiuzhen', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Qingdao University, Qingdao, Shandong 266021, China.'}, {'ForeName': 'Shanliang', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': ""The People's Hospital of Linyi, Linyi, Shandong 276000, China.""}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Qingdao Chest Hospital, Qingdao, Shandong 266042, China.'}, {'ForeName': 'Aiguo', 'Initials': 'A', 'LastName': 'Ma', 'Affiliation': 'Institute of Nutrition and Health, School of Public Health, Qingdao University, Qingdao, Shandong 266021, China. magfood@qdu.edu.cn.'}]",Food & function,['10.1039/c9fo02751c']
855,31974670,Delayed cord clamping in Rh-alloimmunised infants: a randomised controlled trial.,"Despite advancement in medical care, Rh alloimmunisation remains a major cause of neonatal hyperbilirubinaemia, neuro-morbidity, and late-onset anaemia. Delayed cord clamping (DCC), a standard care now-a-days, is yet not performed in Rh-alloimmunised infants due to paucity of evidence. Hence, we randomised these infants of 28- to 41-week gestation to delayed cord clamping (N = 36) or early cord clamping (N = 34) groups. The primary outcome variable was venous packed cell volume (PCV) at 2 h of birth. The secondary outcomes were incidence of double volume exchange transfusion (DVET) and partial exchange transfusion (PET), duration of phototherapy (PT), functional echocardiography (parameters measured: superior vena cava flow, M-mode fractional shortening, left ventricular output, myocardial perfusion index, and inferior vena cava collapsibility) during hospital stay, and blood transfusion (BT) until 14 weeks of life. Neonates were managed as per unit protocol. The baseline characteristics of enrolled infants were comparable between the groups. The median (IQR) gestation and mean (SD) birth weight of enrolled infants were 35 (33-37) weeks and 2440 (542) g, respectively. The DCC group had a higher mean PCV at 2 h of life (48.4 ± 9.2 vs. 43.5 ± 8.7, mean difference 4.9% (95% CI 0.6-9.1), p = 0.03). However, incidence of DVET and PET, duration of PT, echocardiography parameters, and BT until 14 weeks of postnatal age were similar between the groups.Conclusion: DCC in Rh-alloimmunised infants improved PCV at 2 h of age without significant adverse effects.Trial registration: Clinical Trial Registry of India (CTRI), Ref/2016/11/012572 http://ctri.nic.in/Clinicaltrials, date of trial registration 19.12.2016, date of first patient enrolment 1 January 2017.What is Known:•Delayed cord clamping improves haematocrit, results in better haemodynamic stability, and decreases the need of transfusion in early infancy.•However, due to lack of evidence, potential risk of hyperbilirubinaemia, and exacerbation of anaemia (following delayed cord clamping), early cord clamping is the usual norm in Rh-alloimmunised infantsinfants.What is New:•Delayed cord clamping in Rh-alloimmunised infants improves haematocrit at 2 h of life without any increase in incidence of serious adverse effects.",2020,Conclusion: DCC in Rh-alloimmunised infants improved PCV at 2 h of age without significant adverse effects.,"['in Rh-alloimmunised infants', 'infants of 28- to 41-week gestation to delayed cord clamping (N\u2009=\u200936) or early cord clamping (N\u2009=\u200934) groups']","['Delayed cord clamping (DCC', 'Delayed cord clamping']","['haematocrit', 'PCV', 'venous packed cell volume (PCV) at 2\xa0h of birth', 'incidence of DVET and PET, duration of PT, echocardiography parameters', 'incidence of double volume exchange transfusion (DVET) and partial exchange transfusion (PET), duration of phototherapy (PT), functional echocardiography (parameters measured: superior vena cava flow, M-mode fractional shortening, left ventricular output, myocardial perfusion index, and inferior vena cava collapsibility) during hospital stay, and blood transfusion (BT) until 14\xa0weeks of life', 'mean PCV', 'median (IQR) gestation and mean (SD) birth weight']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]","[{'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0018935', 'cui_str': 'Erythrocyte Volume, Packed'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0596292', 'cui_str': 'Cell Volume'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0015236', 'cui_str': 'Exchange Transfusion, Whole Blood'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0042459', 'cui_str': 'Vena Cava, Superior'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042458', 'cui_str': 'Vena Cava, Inferior'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}]",,0.389608,Conclusion: DCC in Rh-alloimmunised infants improved PCV at 2 h of age without significant adverse effects.,"[{'ForeName': 'Tanushree', 'Initials': 'T', 'LastName': 'Sahoo', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Thukral', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India. dranuthukral@gmail.com.'}, {'ForeName': 'M Jeeva', 'Initials': 'MJ', 'LastName': 'Sankar', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Saurabh Kumar', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': 'Department of Cardiology, Division of Pediatric Cardiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Ashok K', 'Initials': 'AK', 'LastName': 'Deorari', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Vinod K', 'Initials': 'VK', 'LastName': 'Paul', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}]",European journal of pediatrics,['10.1007/s00431-020-03578-8']
856,31975359,Back Squat vs. Hip Thrust Resistance-training Programs in Well-trained Women.,"The study compared the effects of back squat (BS) and hip thrust (HT) exercises on muscle strength and hypertrophy in well-trained women. Twenty-two participants were divided in two groups: BS group (n=12, 26.4±1.32 years, 171.8±3.79 cm, and 69.5±4.9 kg) performed the BS exercise and HT group (n=10, 27.5±1.42 years, 170.8±4.4 cm, 67.5±4.7 kg) performed the HT exercise. Training was performed for 12 weeks. Before and after the training period, participants were assessed for quadriceps femoris and gluteus maximus muscle thickness (MT) and 1 repetition maximum (1RM) test on the BS and HT. Both groups significantly increased hip extensors MT and HT 1RM; however, the improvements in BS group were higher than in HT group on quadriceps femoris (12.2% for BS and 2% for HT, P<0.001) and gluteus maximus MT (9.4% for BS and 3.7% for HT, P=0.001) and BS 1 RM (35.9% for BS and 4.3% for HT, P<0.001). BS was more efficient than HT, since it resulted in greater muscle hypertrophy of the quadriceps femoris and gluteus maximus, increases in BS 1RM and similar increases in HT.",2020,"Both groups significantly increased hip extensors MT and HT 1RM; however, the improvements in BS group were higher than in HT group on quadriceps femoris (12.2% for BS and 2% for HT, P<0.001) and gluteus maximus","['Well-trained Women', 'well-trained women']","['BS exercise and HT', 'HT exercise', 'back squat (BS) and hip thrust (HT) exercises', 'Back Squat vs. Hip Thrust Resistance-training Programs']","['muscle strength and hypertrophy', 'quadriceps femoris and gluteus maximus muscle thickness (MT) and 1 repetition maximum (1RM) test on the BS and HT', 'hip extensors MT and HT 1RM', 'muscle hypertrophy of the quadriceps femoris and gluteus maximus, increases in BS 1RM and similar increases in HT', 'BS 1 RM', 'MT']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0224424', 'cui_str': 'Structure of gluteus maximus muscle'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0236033', 'cui_str': 'Muscle hypertrophy (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",22.0,0.0277146,"Both groups significantly increased hip extensors MT and HT 1RM; however, the improvements in BS group were higher than in HT group on quadriceps femoris (12.2% for BS and 2% for HT, P<0.001) and gluteus maximus","[{'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Barbalho', 'Affiliation': 'Faculdade de Educação Física e Dança, Universidade Federal de Goiás, Goiania, Brazil.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Coswig', 'Affiliation': 'Faculdade de Educação Física, Universidade Federal do Pará - Campus Castanhal, Castanhal, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Souza', 'Affiliation': 'Faculdade de Educação Física e Dança, Universidade Federal de Goiás, Goiania, Brazil.'}, {'ForeName': 'Julio Cerca', 'Initials': 'JC', 'LastName': 'Serrão', 'Affiliation': 'Escola de Educação Física e Esporte, Universidade de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Mário', 'Initials': 'M', 'LastName': 'Hebling Campos', 'Affiliation': 'Faculdade de Educação Física e Dança, Universidade Federal de Goiás, Goiania, Brazil.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Gentil', 'Affiliation': 'Faculdade de Educação Física e Dança, Universidade Federal de Goiás, Goiania, Brazil.'}]",International journal of sports medicine,['10.1055/a-1082-1126']
857,31975537,Comparative analysis on the effect of Z-plasty versus conventional simple excision for the treatment of sacrococcygeal pilonidal sinus: A retrospective randomised clinical study.,"Sacrococcygeal pilonidal sinus is one of common diseases in general department. However, it is characterised, for surgeons, by high post-surgical recurrence and high incidence of post-surgical wound complications. Due to that fact, this retrospective randomised clinical study was designed to evaluate the surgical procedure effect of Z-plasty (ZP), compared with convention simple excision (SE). A total of 67 patients from May 2015 to May 2019 in our department were studied into two groups randomly, the group of ZP and the group of SE. The patients' characteristics, surgical data, hospital length of stay (LOS), and post-surgery complications were recorded. Statistical approaches were proceed with P-value analysis. The results are as follows. No significant differences were found between these two groups of the ages, gender distribution, Body Mass Index (BMI), smoking history, diabetes mellitus, and blood hypertension. The estimated blood loss, specimen volume, distance to anus, and drain output on the first day of post-surgery between the two groups were not statistically significant, either. However, surgical time in the ZP group was longer than that in the SE group (P < .0001). LOS in the ZP group was obviously shorter than that in the SE group (P = .0051). Furthermore, the patients of the ZP group were tending to suffer from fewer post-surgical complications than the ones of the SE group. In a conclusion, we hold the point view that the surgical procedure of ZP can lead a better outcome than SE because it demonstrated shortened LOS and fewer post-surgical complications.",2020,"However, surgical time in the ZP group was longer than that in the SE group (P < .0001).","['67 patients from May 2015 to May 2019 in our department', 'sacrococcygeal pilonidal sinus']","['convention simple excision (SE', 'Z-plasty versus conventional simple excision', 'Z-plasty (ZP']","['gender distribution, Body Mass Index (BMI), smoking history, diabetes mellitus, and blood hypertension', 'estimated blood loss, specimen volume, distance to anus, and drain output on the first day of post-surgery', 'surgical data, hospital length of stay (LOS), and post-surgery complications', 'LOS', 'surgical time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031925', 'cui_str': 'Pilonidal Cyst'}]","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0184998', 'cui_str': 'Plastic repair by z plasty (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0005768'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0370005', 'cui_str': 'Specimen volume'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0003461', 'cui_str': 'Anus'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",67.0,0.0179024,"However, surgical time in the ZP group was longer than that in the SE group (P < .0001).","[{'ForeName': 'Yong-Ping', 'Initials': 'YP', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, Second Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Ling-Yun', 'Initials': 'LY', 'LastName': 'Yu', 'Affiliation': 'Department of Ear Nose and Throat Surgery, First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Yi-Zhuo', 'Initials': 'YZ', 'LastName': 'Wang', 'Affiliation': 'Department of Cancer Center, First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of General Surgery, Second Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Jian-Nan', 'Initials': 'JN', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, Second Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Feng-Jia', 'Initials': 'FJ', 'LastName': 'Shang', 'Affiliation': 'Department of General Surgery, Second Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Andrology, First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Tong-Jun', 'Initials': 'TJ', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, Second Hospital of Jilin University, Changchun, China.'}]",International wound journal,['10.1111/iwj.13315']
858,32406601,Goal achievement of A1C and LDL in a Randomized Trial Comparing Colesevelam vs. Ezetimibe: GOAL-RCT.,"AIMS


To compare the efficacy and safety of colesevelam and ezetimibe as second-line LDL lowering options in type 2 diabetes (T2D).
MATERIALS AND METHODS


GOAL-RCT is a 24-week, open label, randomized, pragmatic clinical trial. Subjects with T2D with uncontrolled A1C (7.1-10%) and LDL-c (>2.0 mmol/L) were randomized 1:1 to colesevelam 3.75 g or ezetimibe 10 mg daily. The primary composite outcome was the proportion of participants achieving LDL-c target ≤2.0 mmol/L and A1C target ≤7.0%. Intention to treat analysis was performed.
RESULTS


200 subjects were enrolled: mean age 59 ± 10 years; mean A1C 8.0%; mean LDL-c 2.5 mmol/L; 97% on statin therapy. The primary composite outcome was achieved by similar proportion of participants with colesevelam (14.6%) and ezetimibe (10.5%), p non-inferiority   < 0.001, p superiority   = 0.41. LDL-c reduction from baseline was less with colesevelam compared to ezetimibe (14.0% vs. 23.2%, p < 0.01), as was the proportion of subjects achieving LDL-c target ≤2.0 mmol/L (47.6% and 67.0%, respectively; p = 0.007). Mean A1C was reduced with colesevelam (-0.26 ± 0.10%), while no change was observed with ezetimibe (difference p = 0.06). Adverse events (AE) and discontinuation rates were higher for colesevelam (20.2% and 31.1%) compared to ezetimibe (7.2% and 6.2%), respectively.
CONCLUSIONS


Among subjects with T2D, the initiation of colesevelam or ezetimibe led to similar achievement of primary composite outcome (LDL-c and A1c within target), with ezetimibe recording a greater LDL-c reduction and better toleratability than colesevelam.
CLINICAL TRIAL REGISTRATION


NCT02682680.",2020,"LDL-c reduction from baseline was less with colesevelam compared to ezetimibe (14.0% vs. 23.2%, p < 0.01), as was the proportion of subjects achieving LDL-c target ≤2.0 mmol/L (47.6% and 67.0%, respectively; p = 0.007).","['Subjects with T2D with uncontrolled A1C (7.1-10%) and LDL-c (>2.0\u2009mmol/L', '200 subjects were enrolled: mean age 59\u2009±\u200910\u2009years; mean A1C 8.0%; mean LDL-c 2.5\u2009mmol/L; 97% on statin therapy', 'subjects with T2D, the initiation of colesevelam or', 'type 2 diabetes (T2D']","['colesevelam and ezetimibe', 'Colesevelam vs. Ezetimibe', 'colesevelam 3.75\u2009g or ezetimibe 10\u2009mg daily', 'ezetimibe']","['Mean A1C', 'proportion of participants achieving LDL-c target ≤2.0\u2009mmol/L and A1C target ≤7.0', 'LDL-c reduction', 'efficacy and safety', 'similar proportion of participants with colesevelam', 'LDL-c reduction and better toleratability', 'Adverse events (AE) and discontinuation rates']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0541155', 'cui_str': 'colesevelam'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0541155', 'cui_str': 'colesevelam'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C4517697', 'cui_str': '3.75'}, {'cui': 'C1166438', 'cui_str': 'ezetimibe 10 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0541155', 'cui_str': 'colesevelam'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",200.0,0.101302,"LDL-c reduction from baseline was less with colesevelam compared to ezetimibe (14.0% vs. 23.2%, p < 0.01), as was the proportion of subjects achieving LDL-c target ≤2.0 mmol/L (47.6% and 67.0%, respectively; p = 0.007).","[{'ForeName': 'Harpreet S', 'Initials': 'HS', 'LastName': 'Bajaj', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Brown', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Dishay', 'Initials': 'D', 'LastName': 'Jiandani', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Karri', 'Initials': 'K', 'LastName': 'Venn', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Al-Asaad', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Hasnain', 'Initials': 'H', 'LastName': 'Khandwala', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Steen', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Abdel-Salam', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14084']
859,31975053,Short-term time-restricted feeding is safe and feasible in non-obese healthy midlife and older adults.,"Chronic calorie restriction (CR) improves cardiovascular function and several other physiological markers of healthspan. However, CR is impractical in non-obese older humans due to potential loss of lean mass and bone density, poor adherence, and risk of malnutrition. Time-restricted feeding (TRF), which limits the daily feeding period without requiring a reduction in calorie intake, may be a promising alternative healthspan-extending strategy for midlife and older adults; however, there is limited evidence for its feasibility and efficacy in humans. We conducted a randomized, controlled pilot study to assess the safety, tolerability, and overall feasibility of short-term TRF (eating <8 h day -1  for 6 weeks) without weight loss in healthy non-obese midlife and older adults, while gaining initial insight into potential efficacy for improving cardiovascular function and other indicators of healthspan. TRF was safe and well-tolerated, associated with excellent adherence and reduced hunger, and did not influence lean mass, bone density, or nutrient intake. Cardiovascular function was not enhanced by short-term TRF in this healthy cohort, but functional (endurance) capacity and glucose tolerance were modestly improved. These results provide a foundation for conducting larger clinical studies of TRF in midlife and older adults, including trials with a longer treatment duration.",2020,"TRF was safe and well-tolerated, associated with excellent adherence and reduced hunger, and did not influence lean mass, bone density, or nutrient intake.","['non-obese healthy midlife and older adults', 'healthy non-obese midlife and older adults', 'midlife and older adults']","['Chronic calorie restriction (CR', 'TRF', 'short-term TRF (eating <8\xa0h\xa0day -1  for 6\xa0weeks) without weight loss', 'Time-restricted feeding (TRF', 'Short-term time-restricted feeding']","['Cardiovascular function', 'functional (endurance) capacity and glucose tolerance', 'safe and well-tolerated', 'safety, tolerability, and overall feasibility', 'lean mass, bone density, or nutrient intake', 'cardiovascular function']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0040162', 'cui_str': 'protirelin'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}]","[{'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}]",,0.0344111,"TRF was safe and well-tolerated, associated with excellent adherence and reduced hunger, and did not influence lean mass, bone density, or nutrient intake.","[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Martens', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA. cmartens@udel.edu.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Rossman', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Mazzo', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA.'}, {'ForeName': 'Lindsey R', 'Initials': 'LR', 'LastName': 'Jankowski', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA.'}, {'ForeName': 'Erzsebet E', 'Initials': 'EE', 'LastName': 'Nagy', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA.'}, {'ForeName': 'Blair A', 'Initials': 'BA', 'LastName': 'Denman', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Richey', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Johnson', 'Affiliation': 'Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Ziemba', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Center for Innovative Design & Analysis, University of Colorado School of Public Health, Aurora, CO, 80045, USA.'}, {'ForeName': 'Courtney M', 'Initials': 'CM', 'LastName': 'Peterson', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, 35294, USA.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, Denver, CO, USA.'}, {'ForeName': 'Douglas R', 'Initials': 'DR', 'LastName': 'Seals', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA.'}]",GeroScience,['10.1007/s11357-020-00156-6']
860,32406655,Three-Dimensional Volumetric Changes After Socket Augmentation with Deproteinized Bovine Bone and Collagen Matrix.,"PURPOSE


Socket augmentation decreases the magnitude of alveolar ridge resorption, but the literature is limited in respect to quantifying soft tissue remodeling. The aim of this study was to determine the volumetric and linear dimensional changes at the buccal surface for both hard and soft tissues after socket augmentation treated with a xenogeneic collagen matrix in combination with bone grafting.
MATERIALS AND METHODS


Twenty-four individuals indicated for tooth extraction were enrolled in this investigation. Each participant was randomly assigned to one of two groups: (1) deproteinized bovine bone + collagen plug, or (2) deproteinized bovine bone + xenogeneic collagen matrix. A cone beam computed tomography scan was taken prior to extraction and at 6 months postextraction. Intraoral scanning images were taken at baseline, 3 months, and 6 months postextraction. Hard and soft tissue analyses were performed to compare linear ridge remodeling and volumetric changes by noncontact reverse-engineering software.
RESULTS


Both groups showed bone and soft tissue remodeling. For hard tissue remodeling, there was no significant difference between the collagen plug and collagen matrix groups. For soft tissue remodeling, the collagen matrix group showed a reduced soft tissue loss compared with the collagen plug group. The volumetric analysis demonstrated that the mean buccal soft tissue volume loss for the collagen matrix group was 68.6 mm 3  compared with 87.6 mm 3  found in the collagen plug group (P = .009) over a 6-month period.
CONCLUSION


This clinical investigation provides early evidence of using the total tissue volume to compare soft and hard tissue remodeling after socket augmentation. The results of this study demonstrated that the use of a xenogeneic collagen matrix reduced the buccal soft tissue loss after tooth extraction, but additional studies are necessary to evaluate the clinical significance of soft tissue augmentation after tooth extraction.",2020,"For hard tissue remodeling, there was no significant difference between the collagen plug and collagen matrix groups.",['Twenty-four individuals indicated for tooth extraction were enrolled in this investigation'],"['Deproteinized Bovine Bone and Collagen Matrix', 'xenogeneic collagen matrix', 'deproteinized bovine bone + collagen plug, or (2) deproteinized bovine bone + xenogeneic collagen matrix']","['mean buccal soft tissue volume loss', 'alveolar ridge resorption', 'soft tissue loss', 'bone and soft tissue remodeling', 'buccal soft tissue loss']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}]","[{'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0182324', 'cui_str': 'Plug'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}]",24.0,0.0170066,"For hard tissue remodeling, there was no significant difference between the collagen plug and collagen matrix groups.","[{'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Morelli', 'Affiliation': ''}, {'ForeName': 'Shaoping', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Monaghan', 'Affiliation': ''}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Moss', 'Affiliation': ''}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Lopez', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Marchesan', 'Affiliation': ''}]",The International journal of oral & maxillofacial implants,['10.11607/jomi.7961']
861,32406569,Loop Drainage Is Noninferior to Traditional Incision and Drainage of Cutaneous Abscesses in the Emergency Department.,"BACKGROUND


There is limited research on loop drainage (LD) compared to incision and drainage (I&D) for treatment of cutaneous abscesses. We investigated whether LD was noninferior to I&D for abscess resolution and whether there was any difference in repeat ED visits or complication rates between these techniques.
METHODS


We performed a prospective randomized controlled trial, using a convenience sample at an urban academic emergency department (ED). Subjects over 18 years who presented for first-time management of an abscess were eligible. Patients requiring specialist drainage or hospital admission or had previous treatment for the abscess were excluded. Enrolled subjects were seen 2 weeks after treatment for blinded reevaluation of abscess resolution, and the electronic medical record was reviewed for return ED visits/abscess complications.
RESULTS


Of 2,889 patients screened, 238 subjects consented and were randomized to LD or I&D. Abscess resolution was achieved in 53/65 (81.5%) of patients in the I&D arm, compared to 66/75 (88%) in the LD arm. Fewer patients in the LD group compared to the I&D group returned to the ED for abscess-related management during the following 14 days (37.3% vs 67.1%, p = 0.002). Among returning subjects, there was a significant difference in mean visits per subject between LD and I&D groups (0.5 vs. 1.2, p = 0.001). There were fewer complications among LD than I&D subjects (9.3% vs. 24.6%, p = 0.01).
CONCLUSION


Our study provides evidence that LD is noninferior to I&D in achieving complete abscess resolution at 14 days and is associated with fewer return ED visits and fewer complications. This makes it an attractive alternative treatment option for abscesses.",2020,"Fewer patients in the LD group compared to the I&D group returned to the ED for abscess-related management during the following 14 days (37.3% vs 67.1%,","['convenience sample at an urban academic emergency department (ED', 'Patients requiring specialist drainage or hospital admission or had previous treatment for the abscess were excluded', 'Subjects over 18\xa0years who presented for first-time management of an abscess were eligible', '238 subjects consented', '2,889 patients screened']","['incision and drainage (I&D', 'LD']","['repeat ED visits or complication rates', 'mean visits']","[{'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0206209', 'cui_str': 'Time Management'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0152277', 'cui_str': 'Incision AND drainage'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0205546', 'cui_str': 'Repeat emergency'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",238.0,0.11263,"Fewer patients in the LD group compared to the I&D group returned to the ED for abscess-related management during the following 14 days (37.3% vs 67.1%,","[{'ForeName': 'Elissa M', 'Initials': 'EM', 'LastName': 'Schechter-Perkins', 'Affiliation': 'From the, Department of Emergency Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Kristin H', 'Initials': 'KH', 'LastName': 'Dwyer', 'Affiliation': 'the, Department of Emergency Medicine, Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Anish', 'Initials': 'A', 'LastName': 'Amin', 'Affiliation': 'the, Department of Emergency Medicine, Kaiser Permanante Medical Center, Oakland, CA, USA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Tyler', 'Affiliation': 'the, Department of Emergency Medicine, Advocate Christ Medical Center, Oak Lawn, IL, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'From the, Department of Emergency Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Kerrie P', 'Initials': 'KP', 'LastName': 'Nelson', 'Affiliation': 'and the, School of Public Health, Boston University, Boston, MA, USA.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Mitchell', 'Affiliation': 'From the, Department of Emergency Medicine, Boston University School of Medicine, Boston, MA, USA.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.13981']
862,32406658,Influence of the Dimensions of the Antrostomy on Osseointegration of Mini-implants Placed in the Grafted Region After Sinus Floor Elevation: A Randomized Clinical Trial.,"PURPOSE


To evaluate the osseointegration of mini-implants placed in grafted sinuses with lateral windows of two different dimensions.
MATERIALS AND METHODS


Sinus floor augmentation was performed in volunteers using a lateral window. The antrostomy was systematically prepared with a height of either 8 mm (large group) or 4 mm (small group). After 6 months of healing, mini-implants were placed in the grafted region. Biopsy specimens including the mini-implants were harvested 3 months after placement.
RESULTS


Twenty biopsy specimens, 10 from each group, were suitable for the histologic analysis. Similar amounts of new bone-to-implant contact were obtained in both the large (41.1% ± 19.5%) and the small (42.8% ± 13.2%) groups (P = .940). Small percentages of residues of xenograft were found in contact with the implant surface, with 0.6% ± 1.1% in the large group and 5.9% ± 9.5% in the small group (P = .098). The new bone density around the implants was 31.7% ± 8.2% and 34.0% ± 7.9% in the large and small groups, respectively (P = .623).
CONCLUSION


The dimensions of the antrostomy did not influence the histologic healing of implants placed 6 months after sinus floor augmentation.",2020,The dimensions of the antrostomy did not influence the histologic healing of implants placed 6 months after sinus floor augmentation.,['Sinus floor augmentation was performed in volunteers using a lateral window'],[],"['histologic healing', 'new bone density', 'Small percentages of residues of xenograft']","[{'cui': 'C3178819', 'cui_str': 'Sinus Augmentation Therapy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0557702', 'cui_str': 'Window'}]",[],"[{'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0520484', 'cui_str': 'Xenogeneic transplantation'}]",,0.0382678,The dimensions of the antrostomy did not influence the histologic healing of implants placed 6 months after sinus floor augmentation.,"[{'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Imai', 'Affiliation': ''}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Iezzi', 'Affiliation': ''}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Piattelli', 'Affiliation': ''}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Ferri', 'Affiliation': ''}, {'ForeName': 'Karol Alí Apaza', 'Initials': 'KAA', 'LastName': 'Alccayhuaman', 'Affiliation': ''}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Botticelli', 'Affiliation': ''}]",The International journal of oral & maxillofacial implants,['10.11607/jomi.8005']
863,32406659,Masticatory Efficiency in Implant-Supported Fixed Complete Dentures Compared with Conventional Dentures: A Randomized Clinical Trial by Color-Mixing Analysis Test.,"PURPOSE


To compare the masticatory efficiency of an All-on-4 prosthesis with complete dentures on a Class I ridge with a color-mixing analysis test.
MATERIALS AND METHODS


Ten patients with fixed complete dentures on implants and an additional 10 patients with conventional complete dentures on a Class I ridge (Atwood) chewed a bicolor chewing gum (Hubba Bubba) for different numbers of cycles (5, 10, 15, and 20). The chewed gum was retrieved, scanned, and weighted to quantify masticatory efficiency.
RESULTS


This study showed higher values for implant-supported fixed complete dentures than conventional complete dentures. These findings were significant with the color-mixing test in cycles 5 and 10 between both groups. The reduction in weight was not significantly different between the two groups but was noteworthy in intercycle comparison.
CONCLUSION


Implant-supported fixed complete dentures showed superior masticatory efficiency compared with conventional complete dentures constructed over well-formed ridges in the early chewing cycles.",2020,"CONCLUSION


Implant-supported fixed complete dentures showed superior masticatory efficiency compared with conventional complete dentures constructed over well-formed ridges in the early chewing cycles.","['Implant-Supported Fixed Complete Dentures', 'Ten patients with fixed complete dentures on implants and an additional 10 patients with conventional complete dentures on a Class I ridge (Atwood) chewed a bicolor chewing gum (Hubba Bubba) for different numbers of cycles (5, 10, 15, and 20']",['Conventional Dentures'],"['reduction in weight', 'masticatory efficiency', 'superior masticatory efficiency', 'Masticatory Efficiency']","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0008037', 'cui_str': 'Chewing Gum'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C0457285', 'cui_str': 'Conventional denture'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1282910', 'cui_str': 'Upper'}]",10.0,0.0321325,"CONCLUSION


Implant-supported fixed complete dentures showed superior masticatory efficiency compared with conventional complete dentures constructed over well-formed ridges in the early chewing cycles.","[{'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Jasser', 'Affiliation': ''}, {'ForeName': 'Zahraa', 'Initials': 'Z', 'LastName': 'Salami', 'Affiliation': ''}, {'ForeName': 'Fady', 'Initials': 'F', 'LastName': 'El Hage', 'Affiliation': ''}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Makzoumé', 'Affiliation': ''}, {'ForeName': 'Paul Jamil', 'Initials': 'PJ', 'LastName': 'Boulos', 'Affiliation': ''}]",The International journal of oral & maxillofacial implants,['10.11607/jomi.7911']
864,32406573,Efficacy and safety of lobeglitazone versus sitagliptin as an add-on to metformin in type 2 diabetes with metabolic syndrome over 24 weeks.,"We aimed to evaluate the efficacy and safety profile of lobeglitazone compared with sitagliptin as an add-on to metformin in patients with type 2 diabetes mellitus (T2DM) as well as other components of metabolic syndrome. Patients inadequately controlled by metformin were randomly assigned to lobeglitazone (0.5 mg, n = 121) or sitagliptin (100 mg, n = 126) for 24 weeks. The mean changes in HbA1c of the lobeglitazone and sitagliptin groups were - 0.79% and - 0.86%, respectively; the between-group difference was 0.08% (95% confidence interval, -0.14% to 0.30%), demonstrating non-inferiority. The proportion of patients having two or more factors of other metabolic syndrome components decreased to a greater extent in the lobeglitazone group than in the sitagliptin group (-11.9% vs. -4.8%; P < 0.0174). Favor changes in the lipid metabolism were also observed with lobeglitazone in similar safety to sitagliptin. Lobeglitazone was comparable to sitagliptin as an add-on to metformin in terms of their efficacy and safety. Trial registrations. ClinicalTrials.gov number NCT02480465.",2020,Lobeglitazone was comparable to sitagliptin as an add-on to metformin in terms of their efficacy and safety.,"['type 2 diabetes with metabolic syndrome over 24\u2009weeks', 'patients with type 2 diabetes mellitus (T2DM', 'Patients inadequately controlled by']","['Lobeglitazone', 'lobeglitazone', 'metformin', 'sitagliptin', 'lobeglitazone versus sitagliptin']","['lipid metabolism', 'metabolic syndrome components', 'Efficacy and safety', 'efficacy and safety profile', 'efficacy and safety']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332298', 'cui_str': 'Controlled by'}]","[{'cui': 'C2744790', 'cui_str': 'lobeglitazone'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}]","[{'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",126.0,0.0305888,Lobeglitazone was comparable to sitagliptin as an add-on to metformin in terms of their efficacy and safety.,"[{'ForeName': 'Sin Gon', 'Initials': 'SG', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyoung Jin', 'Initials': 'KJ', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kun Ho', 'Initials': 'KH', 'LastName': 'Yoon', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Sung Wan', 'Initials': 'SW', 'LastName': 'Chun', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, South Korea.'}, {'ForeName': 'Kyong Soo', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Kyung Mook', 'Initials': 'KM', 'LastName': 'Choi', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, South Korea University Guro Hospital, South Korea.'}, {'ForeName': 'Soo', 'Initials': 'S', 'LastName': 'Lim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Ji-Oh', 'Initials': 'JO', 'LastName': 'Mok', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, South Korea.'}, {'ForeName': 'Hyoung Woo', 'Initials': 'HW', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, South Korea.'}, {'ForeName': 'Ji A', 'Initials': 'JA', 'LastName': 'Seo', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University Ansan Hospital, Korea University College of Medicine, Ansan, South Korea.'}, {'ForeName': 'Bong-Soo', 'Initials': 'BS', 'LastName': 'Cha', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Mi Kyung', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Inje University Haeundae Paik Hospital, Inje University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Ho Sang', 'Initials': 'HS', 'LastName': 'Shon', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Dong Seop', 'Initials': 'DS', 'LastName': 'Choi', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Doo Man', 'Initials': 'DM', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, South Korea.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14085']
865,32406581,"Effect of a Water, Sanitation, and Hygiene Program on Handwashing with Soap among Household Members of Diarrhea Patients in Health Facilities in Bangladesh: A Cluster-Randomized Controlled Trial of the CHoBI7 Mobile Health Program.","OBJECTIVE


The Cholera-Hospital-Based-Intervention-for-7-days (CHoBI7) is a water treatment and handwashing with soap intervention for patients and household members which is initially delivered in a health facility setting. This study evaluated the effectiveness of CHoBI7 program delivery in increasing handwashing with soap in a health facility setting.
METHODS


A randomized controlled trial of the CHoBI7 program was conducted among 404 diarrhea patients and their accompanying household members in health facilities in Dhaka, Bangladesh. The ""Standard Message"" arm received the standard message given in Bangladesh to diarrhea patients on the use of oral rehydration solution. The ""Health Facility Visit + Soapy Water"" arm received the standard message, the CHoBI7 communication module delivered bedside to the patient; and a soapy water bottle in the health facility. The ""Health Facility Visit + Handwashing Station"" arm received this same intervention plus a small plastic handwashing station. Within 24 hours of intervention delivery, three-hour structured observation of handwashing practices at stool/vomit and food related events (key events) was conducted in health facilities.
RESULTS


Compared to the Standard Message Arm, there was significantly more handwashing with soap at key events in both the Health Facility Visit + Handwashing Station Arm (58% vs. 25%) (Odds Ratio (OR): 4.12; (95% Confidence Interval (CI): 1.86, 9.14), and the Health Facility Visit + Soapy Water Arm (51% vs. 25 %) (OR: 3.02; (95% CI: 1.41, 6.45).
CONCLUSION


These findings demonstrate that delivery of the CHoBI7 module presents a promising approach to increase handwashing with soap in a health facility setting in Bangladesh.",2020,"Compared to the Standard Message Arm, there was significantly more handwashing with soap at key events in both the Health Facility Visit + Handwashing Station Arm (58% vs. 25%)","['404 diarrhea patients and their accompanying household members in health facilities in Dhaka, Bangladesh', 'Handwashing with Soap among Household Members of Diarrhea Patients in Health Facilities in Bangladesh']","['CHoBI7 program delivery', 'Water, Sanitation, and Hygiene Program', 'Cholera-Hospital-Based-Intervention-for-7-days (CHoBI7', 'CHoBI7 program']",['Health Facility Visit + Soapy Water Arm'],"[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0037392', 'cui_str': 'Soap'}]","[{'cui': 'C0008354', 'cui_str': 'Cholera'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}]","[{'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]",404.0,0.0475223,"Compared to the Standard Message Arm, there was significantly more handwashing with soap at key events in both the Health Facility Visit + Handwashing Station Arm (58% vs. 25%)","[{'ForeName': 'Fatema', 'Initials': 'F', 'LastName': 'Zohura', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Md Sazzadul', 'Initials': 'MS', 'LastName': 'Islam Bhuyian', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'Saxton', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Tahmina', 'Initials': 'T', 'LastName': 'Parvin', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Shirajum', 'Initials': 'S', 'LastName': 'Monira', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Shwapon K', 'Initials': 'SK', 'LastName': 'Biswas', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Jahed', 'Initials': 'J', 'LastName': 'Masud', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Sharika', 'Initials': 'S', 'LastName': 'Nuzhat', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Nowshin', 'Initials': 'N', 'LastName': 'Papri', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tasdik Hasan', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Thomas', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sack', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Perin', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Munirul', 'Initials': 'M', 'LastName': 'Alam', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Marie George', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13416']
866,31972848,Health Literacy and Outcomes of a Community-Based Self-Help Intervention: A Case of Korean Americans With Type 2 Diabetes.,"BACKGROUND


Although scientific reports increasingly document the negative impact of inadequate health literacy on health-seeking behaviors, health literacy's effect on health outcomes in patients with diabetes is not entirely clear, owing to insufficient empirical studies, mixed findings, and insufficient longitudinal research.
OBJECTIVE


The aim of this study was to empirically examine underlying mechanisms of health literacy's role in diabetes management among a group of Korean Americans with Type 2 diabetes mellitus.
METHODS


Data from a randomized clinical trial of a health literacy-focused Type 2 diabetes self-management intervention conducted during 2012-2016 in the Korean American community were collected at baseline and at 3, 6, 9, and 12 months. A total of 250 Korean Americans with Type 2 diabetes participated (intervention, 120; control, 130). Participants were first-generation Korean American immigrants. Health literacy knowledge was measured with the original Rapid Estimate of Adult Literacy in Medicine and the diabetes mellitus-specific Rapid Estimate of Adult Literacy in Medicine. Functional health literacy was measured with the numeracy subscale of the Test of Functional Health Literacy in Adults and the Newest Vital Sign screening instrument, which also uses numeracy. Primary outcomes included glucose control and diabetes quality of life. Multivariate analyses included latent variable modeling.
RESULTS


A series of path analyses identified self-efficacy and self-care skills as significant mediators between health literacy and glucose control and quality of life. Education and acculturation were the most significant correlates of health literacy.
DISCUSSION


Despite inconsistent findings in the literature, this study indicates that health literacy may indirectly influence health outcomes through mediators such as self-care skills and self-efficacy. The study highlights the importance of health literacy, as well as underlying mechanisms with which health literacy influences processes and outcomes of diabetes self-management.",2020,A series of path analyses identified self-efficacy and self-care skills as significant mediators between health literacy and glucose control and quality of life.,"['Korean Americans with Type 2 Diabetes', 'patients with diabetes', '250 Korean Americans with type 2 diabetes participated (intervention, 120; control, 130', 'Korean Americans with type 2 diabetes mellitus', 'Participants were first-generation Korean American immigrants']","['health literacy-focused type 2 diabetes self-management intervention', 'Community-Based Self-Help Intervention']","['glucose control and diabetes quality of life', 'health literacy', 'Health literacy knowledge', 'Functional health literacy', 'health literacy and glucose control and quality of life']","[{'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0597921', 'cui_str': 'Korean Americans'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0034380'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",250.0,0.0347658,A series of path analyses identified self-efficacy and self-care skills as significant mediators between health literacy and glucose control and quality of life.,"[{'ForeName': 'Miyong T', 'Initials': 'MT', 'LastName': 'Kim', 'Affiliation': 'Miyong T. Kim, PhD, RN, FAAN, is Professor, School of Nursing, The University of Texas at Austin. Kim B. Kim, PhD, is President, Korean Resource Center, Ellicott City, Maryland. Jisook Ko, PhD, RN, is Assistant Professor, The University of Texas Health Science Center at San Antonio. Nicole Murry, RN, PhD, is Assistant Professor, School of Nursing, The University of Texas at Austin. Bo Xie, PhD, is Professor, School of Nursing, The University of Texas at Austin. Kavita Radhakrishnan, RN, PhD, is Associate Professor, School of Nursing, The University of Texas at Austin. Hae-Ra Han, PhD, RN, FAAN, is Professor, Johns Hopkins University School of Nursing, Baltimore, Maryland.'}, {'ForeName': 'Kim B', 'Initials': 'KB', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Jisook', 'Initials': 'J', 'LastName': 'Ko', 'Affiliation': ''}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Murry', 'Affiliation': ''}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Radhakrishnan', 'Affiliation': ''}, {'ForeName': 'Hae-Ra', 'Initials': 'HR', 'LastName': 'Han', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000409']
867,30370752,"Land-based and aquatic trunk exercise program improve trunk control, balance and activities of daily living ability in stroke: a randomized clinical trial.","BACKGROUND


There are many land-based or aquatic exercise programs for improving trunk control, balance, and activities of daily living in stroke patients. However, no study has reported the effects of an exercise program that combines land-based and aquatic trunk exercises in stroke patients.
AIM


To investigate the effects of a land-based and aquatic trunk exercise (LATE) program on trunk control, balance, and activities of daily living in chronic stroke patients.
DESIGN


This study was designed as a single-blind randomized controlled trial.
SETTING


Inpatient rehabilitation ward, Goyang, Republic of Korea.
POPULATION


Twenty-nine patients participated in this study.
METHODS


Participants were randomly allocated to the LATE group (N.=14) and control group (N.=15). The LATE program consisted of land-based and aquatic trunk exercises, performed for 30 minutes per day, 5 days per week, for 4 weeks as an adjunct to 30 minutes of conventional physical therapy. The control group underwent only conventional physical therapy for 30 minutes each time, twice per day, 5 days per week, for 4 weeks. The participants were tested before and after the intervention using the Korean Trunk Impairment Scale (K-TIS) and the 5-item, 3-level Postural Assessment Scale for Stroke (PASS-3L) to assess trunk control; the 7-item, 3-level Berg Balance Scale (BBS-3L) and the Functional Reach Test (FRT) to evaluate balance; and the Modified Barthel Index (MBI) to assess activities of daily living.
RESULTS


The LATE group exhibited improvements in K-TIS, PASS-3L, BBS-3L, and MBI scores and FRT distance compared with the control group (P<0.05).
CONCLUSIONS


The results of this study suggest that the LATE program can help improve trunk control, balance, and activities of daily living in chronic stroke patients and may be used as a practical adjunct to conventional physical therapy.
CLINICAL REHABILITATION IMPACT


The LATE program can improve postural control in stroke patients and improve independence in daily activities.",2019,"The LATE group exhibited improvements in K-TIS, PASS-3L, BBS-3L, and MBI scores and FRT distance compared with the control group (P<0.05).
","['Participants were randomly allocated to the LATE group (n=14) and control group (n=15', 'Twenty-nine patients participated in this study', 'stroke patients', 'chronic stroke patients', 'stroke']","['aquatic exercise programs', 'exercise program that combines land-based and aquatic trunk exercises', 'land-based and aquatic trunk exercises', 'land-based and aquatic trunk exercise (LATE) program', 'Land-based and acquatic trunk exercise program', 'conventional physical therapy']","['K-TIS, PASS-3L, BBS-3L, and MBI scores and FRT distance', 'trunk control, balance and activities of daily living ability', 'postural control', 'trunk control, balance, and activities of daily living', 'Korean Trunk Impairment Scale (KTIS) and the 5-item, 3-level Postural Assessment Scale for Stroke (PASS-3L) to assess trunk control; the 7-item, 3-level Berg Balance Scale (BBS-3L) and the Functional Reach Test (FRT) to evaluate balance; and the Modified Barthel Index (MBI) to assess activities of daily living']","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0454352', 'cui_str': 'Trunk exercises (regime/therapy)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0426971', 'cui_str': 'Trunk control (observable entity)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0582381', 'cui_str': 'Assess activities of daily living (ADLS)'}]",29.0,0.02065,"The LATE group exhibited improvements in K-TIS, PASS-3L, BBS-3L, and MBI scores and FRT distance compared with the control group (P<0.05).
","[{'ForeName': 'Hye-Kang', 'Initials': 'HK', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Graduate School Sahmyook University, Seoul, Republic of Korea.'}, {'ForeName': 'Hwang-Jae', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Health Sciences and Technology, Samsung Advanced Institute for Health Science and Technology (SAIHST), Samsung Medical Center, Sungkyunkwan University, Seoul, Republic of Korea.'}, {'ForeName': 'Su-Jin', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, Graduate School Sahmyook University, Seoul, Republic of Korea.'}, {'ForeName': 'Wan-Hee', 'Initials': 'WH', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, Sahmyook University College of Health Science, Seoul, Republic of Korea - whlee@syu.ac.kr.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.18.05369-8']
868,31644514,Glottic visibility for laryngeal surgery: Tritube vs. microlaryngeal tube: A randomised controlled trial.,"BACKGROUND


Good visibility is essential for successful laryngeal surgery. A Tritube with outer diameter 4.4 mm, combined with flow-controlled ventilation (FCV), enables ventilation by active expiration with a sealed trachea and may improve laryngeal visibility.
OBJECTIVES


We hypothesised that a Tritube with FCV would provide better laryngeal visibility and surgical conditions for laryngeal surgery than a conventional microlaryngeal tube (MLT) with volume-controlled ventilation (VCV).
DESIGN


Randomised, controlled trial.
SETTING


University Medical Centre.
PATIENTS


A total of 55 consecutive patients (>18 years) undergoing elective laryngeal surgery were assessed for participation, providing 40 evaluable data sets with 20 per group.
INTERVENTIONS


Random allocation to intubation with Tritube and ventilation with FCV (Tritube-FCV group) or intubation with MLT 6.0 and ventilation with VCV (MLT-VCV) as control. Tidal volumes of 7 ml kg predicted body weight, and positive end-expiratory pressure of 7 cmH2O were standardised between groups.
MAIN OUTCOME MEASURES


Primary endpoint was the tube-related concealment of laryngeal structures, measured on videolaryngoscopic photographs by appropriate software. Secondary endpoints were surgical conditions (categorical four-point rating scale), respiratory variables and change of end-expiratory lung volume from atmospheric airway pressure to ventilation with positive end-expiratory pressure. Data are presented as median [IQR].
RESULTS


There was less concealment of laryngeal structures with the Tritube than with the MLT; 7 [6 to 9] vs. 22 [18 to 27] %, (P < 0.001). Surgical conditions were rated comparably (P = 0.06). A subgroup of residents in training perceived surgical conditions to be better with the Tritube compared with the MLT (P = 0.006). Respiratory system compliance with the Tritube was higher at 61 [52 to 71] vs. 46 [41 to 51] ml cmH2O (P < 0.001), plateau pressure was lower at 14 [13 to 15] vs. 17 [16 to 18] cmH2O (P < 0.001), and change of end-expiratory lung volume was higher at 681 [463 to 849] vs. 414 [194 to 604] ml, (P = 0.023) for Tritube-FCV compared with MLT-VCV.
CONCLUSION


During laryngeal surgery a Tritube improves visibility of the surgical site but not surgical conditions when compared with a MLT 6.0. FCV improves lung aeration and respiratory system compliance compared with VCV.
TRIAL REGISTRY NUMBER


DRKS00013097.",2019,During laryngeal surgery a Tritube improves visibility of the surgical site but not surgical conditions when compared with a MLT 6.0.,"['55 consecutive patients (>18 years) undergoing elective laryngeal surgery were assessed for participation, providing 40 evaluable data sets with 20 per group', 'laryngeal surgery', 'University Medical Centre']","['conventional microlaryngeal tube (MLT) with volume-controlled ventilation (VCV', 'Tritube® vs. microlaryngeal tube', 'cmH2O', 'FCV', 'combined with flow-controlled ventilation (FCV', 'Random allocation to intubation with Tritube and ventilation with FCV (Tritube-FCV group) or intubation with MLT 6.0 and ventilation with VCV (MLT-VCV']","['concealment of laryngeal structures', 'Respiratory system compliance', 'plateau pressure', 'change of end-expiratory lung volume', 'laryngeal visibility and surgical conditions', 'surgical conditions (categorical four-point rating scale), respiratory variables and change of end-expiratory lung volume from atmospheric airway pressure to ventilation with positive end-expiratory pressure', 'visibility of the surgical site', 'tube-related concealment of laryngeal structures, measured on videolaryngoscopic photographs by appropriate software', 'lung aeration and respiratory system compliance', 'Glottic visibility', 'Tidal volumes of 7\u200aml\u200akg predicted body weight, and positive end-expiratory pressure of 7\u200acmH2O']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C1320708', 'cui_str': 'Volume controlled ventilation'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C0015763', 'cui_str': 'Calicivirus, Feline'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0419011', 'cui_str': 'Controlled ventilation (procedure)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C3541375', 'cui_str': 'RESPIRATORY SYSTEM'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0445176', 'cui_str': 'Plateau pressure (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0442700', 'cui_str': 'End-expiration'}, {'cui': 'C0231953', 'cui_str': 'Lung volume, function (observable entity)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441468', 'cui_str': 'Photograph (physical object)'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}]",55.0,0.107937,During laryngeal surgery a Tritube improves visibility of the surgical site but not surgical conditions when compared with a MLT 6.0.,"[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': 'From the Department of Anaesthesiology and Critical Care (JS, FG, JW, VK, CW, SB, SW, SS) and Department of Otorhinolaryngology (JP, CB), Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Günther', 'Affiliation': ''}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Weber', 'Affiliation': ''}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Kehm', 'Affiliation': ''}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Pfeiffer', 'Affiliation': ''}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Becker', 'Affiliation': ''}, {'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Wenzel', 'Affiliation': ''}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Borgmann', 'Affiliation': ''}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Wirth', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schumann', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001110']
869,31957558,Prenatal docosahexaenoic acid supplementation has long-term effects on childhood behavioral and brain responses during performance on an inhibitory task.,"Introduction:  Offsprings from a prenatal docosahexaenoic acid (DHA) supplementation trial, in which pregnant women were assigned to placebo or 600mg DHA/day, were followed to determine the effect of prenatal DHA supplementation on the behavior and brain function at 5.5 years (n=81 placebo, n=86 supplemented). Methods:  Event-related potentials (ERP) were recorded during a visual task requiring a button press (Go) to frequent target stimuli and response inhibition to the rare stimuli (No-Go). Univariate ANOVAs were used to test differences between group and sex for behavioral measures. ERP differences were tested using a three-way mixed-design multivariate analysis of variance (MANOVA). Results:  There was a significant sex × group interaction for hit rate and errors of omission; there was no difference between males and females in the placebo group, but DHA males outperformed DHA females. Males overall and the placebo group made more errors requiring response inhibition; DHA females were significantly better than placebo females and DHA males. ERP P2 amplitude was larger in the DHA group. A significant N2 amplitude condition effect was observed in females and DHA group males, but not in placebo group males. Discussion:  Prenatal DHA supplementation improved inhibitory performance overall, especially for females in the DHA group, possibly accounting for their conservative behavior during Go trials. Development of brain regions responsible for visual processing may be sensitive to maternal DHA status, evidenced by greater P2 amplitude. Males may benefit more from maternal DHA supplementation, indicated by the N2 condition effect seen only in males in the DHA group.",2020,Males overall and the placebo group made more errors requiring response inhibition; DHA females were significantly better than placebo females and DHA males.,['pregnant women'],"['placebo', 'Prenatal docosahexaenoic acid supplementation', 'prenatal DHA supplementation', 'Prenatal DHA supplementation', 'prenatal docosahexaenoic acid (DHA) supplementation']","['errors requiring response inhibition; DHA females', 'hit rate and errors of omission', 'N2 amplitude condition effect', 'Event-related potentials (ERP', 'ERP P2 amplitude', 'childhood behavioral and brain responses']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556102', 'cui_str': 'DHA - Docosahexaenoic acid supplementation'}]","[{'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0596020', 'cui_str': 'Does hit (finding)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0282171', 'cui_str': 'Potentials, Event-Related'}, {'cui': 'C0337380', 'cui_str': 'Endoscopic retrograde pancreatography (procedure)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}]",86.0,0.176488,Males overall and the placebo group made more errors requiring response inhibition; DHA females were significantly better than placebo females and DHA males.,"[{'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Gustafson', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center (KUMC), Kansas City, KS, USA.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Liao', 'Affiliation': 'Hoglund Brain Imaging Center, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Nicole B', 'Initials': 'NB', 'LastName': 'Mathis', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center (KUMC), Kansas City, KS, USA.'}, {'ForeName': 'D Jill', 'Initials': 'DJ', 'LastName': 'Shaddy', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Kerling', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Danielle N', 'Initials': 'DN', 'LastName': 'Christifano', 'Affiliation': 'Hoglund Brain Imaging Center, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Colombo', 'Affiliation': 'Department of Psychology/Schiefelbusch Institute for Life Span Studies, University of Kansas (KU), Lawrence, KS, USA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Carlson', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, KS, USA.'}]",Nutritional neuroscience,['10.1080/1028415X.2020.1712535']
870,31977929,Placebo effect in children: the role of expectation and learning.,"Classical conditioning and expectations are well-known underlying mechanisms of placebo hypoalgesia. Only little is known about their differential effect in adults, however, and even less in children. Previous studies in children evoked placebo hypoalgesia either with expectations alone or in combination with classical conditioning and revealed conflicting results. Furthermore, these studies investigated children of different ages making it even more difficult to draw conclusions. This study tried to disentangle classical conditioning and expectations by investigating them separately. To examine age effects, n = 172 children (6-9, 10-13, and 14-17 years) as well as n = 32 adults (> = 18 years) were tested using a heat pain paradigm investigating the effectiveness of creams some of which were bogusly introduced as analgesic. In addition to subjective pain intensity ratings, peripheral physiological measures were recorded. Results showed a successful induction of placebo hypoalgesia by both mechanisms for pain ratings and heart rate acceleration. Placebo hypoalgesia was particularly pronounced in children younger than 14 years. Furthermore, placebo hypoalgesia was more marked in children whose mothers raised the expectations. It was also stronger in participants who noticed a strong pain reduction during learning trials. These results encourage the use of placebo effect in clinical practice, particularly for younger children. They underline the relevance of an initial pain reduction and encourage the inclusion of parents in treatment.",2020,Placebo hypoalgesia was particularly pronounced in children under fourteen years.,"['children', '172 children (6-9, 10-13 and 14-17 years) as well as n = 32 adults (> 18 years', 'younger children', 'children under fourteen years']","['Placebo', 'placebo']","['pain ratings and heart rate acceleration', 'subjective pain intensity ratings peripheral physiological measures']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",172.0,0.0940302,Placebo hypoalgesia was particularly pronounced in children under fourteen years.,"[{'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Gniß', 'Affiliation': 'Department of Clinical Psychology, Justus-Liebig-University Giessen, Giessen, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Kappesser', 'Affiliation': ''}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Hermann', 'Affiliation': ''}]",Pain,['10.1097/j.pain.0000000000001811']
871,31615192,The therapeutic role of motor imagery during the chronic phase after total knee arthroplasty: a pilot randomized controlled trial.,"BACKGROUND


There is now ample evidence that motor imagery contributes to enhance motor learning and promote motor recovery in patients with motor disorders. Whether motor imagery practice is likely to facilitate mobility in patients suffering from knee osteoarthritis, at 6-months after total knee arthroplasty, remains unknown.
AIM


This trial was designed to evaluate the therapeutic effectiveness of implementing motor imagery into the classical course of physical therapy at 6-months after total knee arthroplasty.
DESIGN


Randomized controlled trial.
POPULATION


Twenty-four patients with unilateral total knee arthroplasty were assigned to a motor imagery or control group in a test-retest procedure, following a rehabilitation program as outpatients.
METHODS


During both the pre- and post-test, a set of strength and functional mobility measures were assessed: quadriceps strength, peak knee flexion during the swing phase, performance at the timed up and go test, stair climbing test, and 6-minute walk test, and finally Oxford knee score. In addition to a common physical therapy program, the motor imagery group practiced additional motor imagery exercises, while participants of the control group were subjected to a period of neutral activities for an equivalent amount of time.
RESULTS


Data provided evidence that motor imagery enhanced the quadriceps muscle strength of the operated knee (F (1, 22)=10.36, P=0.003), improved the peak knee flexion during the swing phase (F (1, 22)=31.52, P<0.001), and increased the speed to climb and descend stairs (F (1, 22)=14.28, P=0.001).
CONCLUSIONS


This study demonstrated the effectiveness of motor imagery exercises in gait performance and functional recovery in a small sample of individuals who underwent total knee arthroplasty. However, before drawing final conclusions sample size calculation should be conducted in the future.
CLINICAL REHABILITATION IMPACT


While waiting for further research, our findings encourage incorporating motor imagery exercises into classical physical therapy protocols at 6-months after total knee arthroplasty.",2019,"10.36, p = 0.003), improved the peak knee flexion during the swing phase (F (1, 22) =","['Twenty-four patients with unilateral total knee arthroplasty', 'individuals who underwent total knee arthroplasty', 'patients suffering from knee osteoarthritis', 'patients with motor disorders', 'chronic phase after total knee arthroplasty']","['motor imagery or control group in a test-retest procedure', 'physical therapy', 'motor imagery exercises', 'motor imagery group practiced additional motor imagery exercises']","['speed to climb and descend stairs', 'quadriceps strength, peak knee flexion during the swing phase, performance at the timed up and go test, stair climbing test, and 6- minute walk test, and finally Oxford knee score', 'quadriceps muscle strength', 'gait performance and functional recovery', 'peak knee flexion']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0221163', 'cui_str': 'Motor Disorders'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase (qualifier value)'}]","[{'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018262', 'cui_str': 'Group Practice'}]","[{'cui': 'C0561942', 'cui_str': 'Does climb (finding)'}, {'cui': 'C0205386', 'cui_str': 'Descending (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0430519', 'cui_str': 'Stair-climbing test (procedure)'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score (observable entity)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",24.0,0.06458,"10.36, p = 0.003), improved the peak knee flexion during the swing phase (F (1, 22) =","[{'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Moukarzel', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology (LIBM, EA7424), Claude Bernard Lyon 1 University, Lyon, France.'}, {'ForeName': 'Aymeric', 'Initials': 'A', 'LastName': 'Guillot', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology (LIBM, EA7424), Claude Bernard Lyon 1 University, Lyon, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Di Rienzo', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology (LIBM, EA7424), Claude Bernard Lyon 1 University, Lyon, France.'}, {'ForeName': 'Nady', 'Initials': 'N', 'LastName': 'Hoyek', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology (LIBM, EA7424), Claude Bernard Lyon 1 University, Lyon, France - nady.hoyek@univ-lyon1.fr.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.19.05136-0']
872,31644511,Laryngoscopic techniques modulate anaesthesiologists' perception of halitosis in patients: A randomised controlled trial.,"BACKGROUND


Perception of halitosis in patients during intubation is a common and additional stressor for anaesthesiologists and may lead to potential health risks.
OBJECTIVES


We hypothesised that intubation with videolaryngoscopy could help reduce the anaesthesiologists' perception of patients' oral malodor during intubation.
DESIGN


A single-blinded, randomised controlled trial.
SETTING


Single centre general hospital, Guangdong Province, China.
PARTICIPANTS


A total of 440 patients who underwent intubation under general anaesthesia for elective surgery, aged 18 to 60 years old, American Society of Anaesthesiologists class I to III, without upper airway abnormality or airway infection were enrolled.
INTERVENTION


Patients were randomly assigned to receive either UE videolaryngoscopy (UE) or Macintosh's direct laryngoscopy (Macintosh) group. All intubations were performed by one of six very experienced anaesthesiologists.
MAIN OUTCOME MEASURES


The patient's oral odour score was measured prior to induction of anaesthesia. The anaesthesiologists' perception of the patient's oral malodor during intubation was recorded. The shortest distance from patient's mouth to the anaesthesiologist's nose (MN distance), the exertion rating and discomfort were also measured.
RESULTS


The oral malodor score did not differ in the UE and Macintosh groups prior to the induction of anaesthesia. However, the incidence of the anaesthesiologists' perception of halitosis during intubation was significantly lower in the UE group compared with the Macintosh group (P < 0.001). Similarly, the MN distance was significantly greater in the UE group compared with the Macintosh group (P < 0.001). The first-attempt success rate was higher in the UE group compared to the Macintosh group (P < 0.001). However, the exertion scores were considerably higher in the Macintosh group. After intubation, anaesthesiologists experienced more waist and shoulder discomfort with the Macintosh than the UE technique of intubation.
CONCLUSION


Compared with direct laryngoscopy, videolaryngoscopy might reduce the anaesthesiologists' perception of the patients' oral malodor, help improve first-attempt success rate, as well as alleviate the anaesthesiologists' waist and shoulder discomfort.
TRIAL REGISTRATION


Clinicaltrials.gov (ChiCTR-IOR-15007038).",2019,The oral malodor score did not differ in the UE and Macintosh groups prior to the induction of anaesthesia.,"['A total of 440 patients who underwent intubation under general anaesthesia for elective surgery, aged 18 to 60 years old, American Society of Anaesthesiologists class I to III, without upper airway abnormality or airway infection were enrolled', 'Single centre general hospital, Guangdong Province, China', 'halitosis in patients', ""patients' oral malodor during intubation""]","['videolaryngoscopy', 'Laryngoscopic techniques', 'direct laryngoscopy, videolaryngoscopy', ""UE videolaryngoscopy (UE) or Macintosh's direct laryngoscopy (Macintosh) group""]","['success rate', 'oral malodor score', 'exertion rating and discomfort', 'waist and shoulder discomfort', 'exertion scores', ""anaesthesiologists' perception of halitosis during intubation"", 'MN distance']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517777', 'cui_str': '440 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0018520', 'cui_str': 'Halitosis'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0429689', 'cui_str': 'Exertion rating (staging scale)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C1096593', 'cui_str': 'Shoulder discomfort'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018520', 'cui_str': 'Halitosis'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}]",440.0,0.0872739,The oral malodor score did not differ in the UE and Macintosh groups prior to the induction of anaesthesia.,"[{'ForeName': 'Chaojin', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Ziqing', 'Initials': 'Z', 'LastName': 'Hei', 'Affiliation': ''}, {'ForeName': 'Jibin', 'Initials': 'J', 'LastName': 'Xing', 'Affiliation': ''}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Rongzong', 'Initials': 'R', 'LastName': 'Qiu', 'Affiliation': ''}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Chulian', 'Initials': 'C', 'LastName': 'Gong', 'Affiliation': ''}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Shaoli', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Shen', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001115']
873,31489809,Pillow preferences of people with neck pain and known spinal degeneration: a pilot randomized controlled trial.,"BACKGROUND


In people without cervical pathologies, changing to a latex or polyester pillow is reported to decrease waking cervical symptoms. Whether this also occurs for people with spinal degeneration in the neck is unknown.
AIM


This pilot study tested recruitment strategies for people with cervical spine degeneration, and the effect of different pillows on cervical waking symptoms, sleep quality, cervical range of motion, neck disability index and quality of life.
DESIGN


A randomized sequential-block double-blind controlled trial.
SETTING


A community-based study.
POPULATION


Adult volunteers (18+ years) with regular waking cervical symptoms (headache, cervical pain and/or stiffness, scapular pain), confirmed radiologic evidence of cervical spine degeneration, side sleeper and ""usual"" use of one pillow.
METHODS


Participants were recruited, through community advertising at medical and physiotherapy practices, local community groups, and via newspaper, radio and websites. After screening for eligibility, they tested latex and polyester pillows for 28 days each, interspersed with 28 days on ""usual"" pillow for washout, and comparison. Subjects ceased using a trial pillow if it affected sleep quality or waking symptoms. Cervical range of motion, neck disability index and quality of life were measured pre-post each pillow trial, whilst waking symptoms and sleep quality were assessed daily.
RESULTS


Of 117 local volunteers, 92 had radiologically-confirmed cervical spondylosis, and a further 45 (48.9%) were excluded for medical conditions, sleep position and/or pillow use. Approximately 70% ""usual"" pillows were polyester. Overall no pillow significantly altered any outcome measure. Considering trends however, the polyester pillow significantly increased side flexion range of movement on waking and showed some effect on nocturnal-waking cervical pain. The latex pillow did not perform well on any outcome measure. Significantly more subjects completed the polyester pillow trial than the latex pillow trial (post-hoc power 80% vs. 55%).
CONCLUSIONS


Well-powered studies to truly detect pillow impact on waking symptoms and sleep quality require 400+ symptomatic subjects.
CLINICAL REHABILITATION IMPACT


It has previously been reported that using a latex or polyester pillow significantly improves waking cervical symptoms in the general population. This pilot study did not replicate these results in people with known cervical spine degeneration.",2019,The latex pillow did not perform well on any outcome measure.,"['117 local volunteers, 92 had radiologically-confirmed cervical spondylosis, and a further 45 (48.9%) were excluded for medical conditions, sleep position and/or pillow use', 'people with cervical spine degeneration', 'Participants were recruited, through community advertising at medical and physiotherapy practices, local community groups, and via newspaper, radio and websites', ""Adult volunteers (18+ years) with regular waking cervical symptoms (headache, cervical pain and/or stiffness, scapular pain), confirmed radiologic evidence of cervical spine degeneration, side sleeper and 'usual' use of one pillow"", 'A community based study', 'people with neck pain and known spinal degeneration', 'people with known cervical spine degeneration']",['latex or polyester pillow'],"['Cervical range of motion, neck disability index and quality of life', 'side flexion range of movement on waking', 'cervical waking symptoms, sleep quality, cervical range of motion, neck disability index and quality of life', 'sleep quality or waking symptoms', 'nocturnal - waking cervical pain', 'waking cervical symptoms', 'waking symptoms and sleep quality']","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1384641', 'cui_str': 'Cervical spondylosis (disorder)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0182291', 'cui_str': 'Pillow, device (physical object)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1442868', 'cui_str': 'Cervical spine degeneration'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0027989', 'cui_str': 'Newspapers'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205483', 'cui_str': 'Radiologic (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0850918', 'cui_str': 'Degeneration of spine'}]","[{'cui': 'C0023115', 'cui_str': 'Latex'}, {'cui': 'C0032474', 'cui_str': 'Polyesters'}, {'cui': 'C0182291', 'cui_str': 'Pillow, device (physical object)'}]","[{'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034380'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0585034', 'cui_str': 'On waking (qualifier value)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}]",,0.461643,The latex pillow did not perform well on any outcome measure.,"[{'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Gordon', 'Affiliation': 'Flinders University, Adelaide, Australia - sue.gordon@flinders.edu.au.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Grimmer', 'Affiliation': 'Flinders University, Adelaide, Australia.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Buttner', 'Affiliation': 'James Cook University, Douglas, Australia.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.19.05263-8']
874,30788810,Pretreatment with glucose-insulin-potassium improves ventricular performances after coronary artery bypass surgery: a randomized controlled trial.,"Heart failure is the main cause of poor outcome following open heart surgery and experimental studies have demonstrated that glucose-insulin-potassium (GIK) infusion exerts cardioprotective effects by reducing myocardial ischemia-reperfusion injuries. This randomized controlled trial was designed to assess the effects of GIK on left ventricular function in moderate-to-high risk patients undergoing on-pump isolated coronary artery bypass surgery (CABGS), or combined with aortic valve replacement. The primary outcomes were the effects of GIK on two- and three-dimensional left ventricular ejection fraction (2D and 3D-LVEF), and on transmitral flow propagation velocity (Vp), that occurred between the pre- and post-CPB periods. GIK administration was associated with favorable interaction effects (p < 0.001) on 2D-LVEF, 3D-LVEF and Vp changes over the study periods. In GIK pretreated patients (N = 54), 2-D and 3D-LVEF and Vp increased slightly during surgery (mean difference [MD] + 3.5%, 95% confidence interval [95% CI] - 0.2 to 7.1%, MD + 4.0%, 95% CI 0.6-7.4%, and MD + 22.2%, 95% CI 16.0-28.4%, respectively). In contrast, in the Placebo group (N = 46), 2D-and 3D-LVEF, as well as Vp all decreased after CPB (MD - 7.5% [- 11.6 to - 3.4%], MD - 12.0% [- 15.2 to - 8.8%] and MD - 21.3% [- 25.7 to - 16.9%], respectively). In conclusion, the administration of GIK resulted in better preservation of systolic and diastolic ventricular function in the early period following weaning from CPB.",2020,"GIK administration was associated with favorable interaction effects (p < 0.001) on 2D-LVEF, 3D-LVEF and Vp changes over the study periods.","['after coronary artery bypass surgery', 'moderate-to-high risk patients undergoing on-pump isolated coronary artery bypass surgery (CABGS), or combined with aortic valve replacement']","['Placebo', 'glucose-insulin-potassium (GIK) infusion', 'GIK', 'glucose-insulin-potassium']","['favorable interaction effects', 'ventricular performances', 'systolic and diastolic ventricular function', 'effects of GIK on two- and three-dimensional left ventricular ejection fraction (2D and 3D-LVEF), and on transmitral flow propagation velocity (Vp']","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}]",,0.276672,"GIK administration was associated with favorable interaction effects (p < 0.001) on 2D-LVEF, 3D-LVEF and Vp changes over the study periods.","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Licker', 'Affiliation': 'Department of Anaesthesiology, Pharmacology and Intensive Care, University Hospital of Geneva, Rue Gabrielle-Perret-Gentil 4, 1211, Geneva, Switzerland. marc-joseph.licker@hcuge.ch.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Reynaud', 'Affiliation': 'Department of Anaesthesiology, Pharmacology and Intensive Care, University Hospital of Geneva, Rue Gabrielle-Perret-Gentil 4, 1211, Geneva, Switzerland.'}, {'ForeName': 'Najia', 'Initials': 'N', 'LastName': 'Garofano', 'Affiliation': 'Department of Anaesthesiology, Pharmacology and Intensive Care, University Hospital of Geneva, Rue Gabrielle-Perret-Gentil 4, 1211, Geneva, Switzerland.'}, {'ForeName': 'Tornike', 'Initials': 'T', 'LastName': 'Sologashvili', 'Affiliation': 'Division of Cardiovascular Surgery, University Hospital of Geneva, Geneva, Switzerland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Diaper', 'Affiliation': 'Department of Anaesthesiology, Pharmacology and Intensive Care, University Hospital of Geneva, Rue Gabrielle-Perret-Gentil 4, 1211, Geneva, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Ellenberger', 'Affiliation': 'Department of Anaesthesiology, Pharmacology and Intensive Care, University Hospital of Geneva, Rue Gabrielle-Perret-Gentil 4, 1211, Geneva, Switzerland.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-019-00280-5']
875,31939265,"Extracorporeal shock wave therapy for treatment of vulvodynia: a prospective, randomized, double-blind, placebo-controlled study.","BACKGROUND


Currently, there are no effective therapy strategies for idiopathic, non-organic vulvodynia in women. ESWT (extracorporeal shock wave therapy) is a nonsurgical/noninvasive technique widely used to treat musculoskeletal diseases, muscle spasticity and hypertonia, renal and biliary calculi and urological disorders.
AIM


We examined the effects of ESWT on vulvodynia in women.
DESIGN


A prospective, randomized, double-blind, placebo-controlled study was conducted between 2015 and 2018 following a feasibility study.
SETTING


Obstetrics and Gynecology Hospital departments.
POPULATION


The study included 62 women with vulvodynia for at least 3 months.
METHODS


The women were randomly assigned to either a treatment group (N.=31) or a placebo group (N.=31). The patients in the treatment group received perineally applied ESWT weekly (3000 pulses each for four consecutive weeks). The energy flux density was 0.25 mJ/mm2, frequency 4 Hz, focus zone 0-30 mm, therapeutic efficacy 0-90 mm, stand-off II. The device used was a standard electromagnetic shock wave unit with a focused shock wave handpiece. The position of the shock wave transducer was changed six times after every 500 pulses. Patients in the placebo group underwent the same treatment procedure, but the handpiece was provided with a placebo stand-off that disabled energy transmission. Subjective pain was self-evaluated by each patient using two tools before and after treatment: a 10 cm linear visual analogue scale (VAS, 0-10) and a cotton-swab test (CST, Goetsch scale 0-4). Follow-ups were done 1, 4, and 12 weeks post-ESWT.
RESULTS


In all, 61 women completed the study. We tested for differences in the VAS and CST within and between the treatment and placebo groups. The testing was between before treatment and particular follow-up. We found significant changes in the treatment group. Reductions in VAS (P<0.01) and CST (P<0.01) were observed at all three follow-ups. At all assessments, pain reduction was always >30%. In the placebo group there were no statistically significant changes between before and after treatment. There were no differences between the treatment and placebo groups before treatment but statistically significant differences at all three follow-ups (VAS P<0.01); CST P<0.01).
CONCLUSIONS


ESWT seems to reduce pain perception in our treatment group. Thus, we are encouraged to explore this technique further.
CLINICAL REHABILITATION IMPACT


The method is easily replicable, inexpensive, and without known side effects.",2020,"There were no differences between the treatment and placebo groups before treatment but statistically significant differences at all three follow-ups (VAS p<0.01); CST p<0.01).
","['2015 and 2018 following a feasibility study', 'women', '62 women with vulvodynia for at least 3 months', 'vulvodynia', '61 women completed the study']","['perineally applied ESWT', 'Extracorporeal shock wave therapy', 'ESWT (extracorporeal shock wave therapy', 'ESWT', 'placebo', 'placebo stand- off that disabled energy transmission']","['pain perception', 'pain reduction', 'Reductions in VAS', 'Subjective pain', 'energy flux density']","[{'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0015730', 'cui_str': 'Feasibility Studies'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0406670', 'cui_str': 'Vulvodynias'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0522650', 'cui_str': 'External prosthesis for sonographic procedure, device (physical object)'}, {'cui': 'C0040722', 'cui_str': 'transmission'}]","[{'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}]",62.0,0.185785,"There were no differences between the treatment and placebo groups before treatment but statistically significant differences at all three follow-ups (VAS p<0.01); CST p<0.01).
","[{'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Hurt', 'Affiliation': 'Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University, Prague, Czech Republic - hurt@infoprague.com.'}, {'ForeName': 'Frantisek', 'Initials': 'F', 'LastName': 'Zahalka', 'Affiliation': 'Sports Motoric Laboratory, Faculty of Physical Education and Sport, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Halaska', 'Affiliation': 'Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Rakovicova', 'Affiliation': 'OBGYN Department Amedeana Prague, Prague, Czech Republic.'}, {'ForeName': 'Aneta', 'Initials': 'A', 'LastName': 'Krajcova', 'Affiliation': 'Department of Plastic Surgery, First Faculty of Medicine, Charles University, Prague, Czech Republic.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.20.05903-1']
876,32406725,Are Fitbits implicated in body image concerns and disordered eating in women?,"OBJECTIVE


Using a daily monitoring framework, we examined the psychological consequences of Fitbit self-tracking on state body satisfaction, disordered eating (DE; i.e., binge eating and dietary restraint), levels of exercise engagement, and motivations (appearance vs. fitness/health) in adult women. A further aim within the Fitbit group was to assess whether the level of steps achieved on 1 day would be associated with the state-based outcome measures on the subsequent day.
METHOD


In total, 262 participants who had never used a wearable fitness self-tracking device were allocated to a Fitbit ( n  = 101) or control condition ( n  = 161). Participants provided baseline data on sociodemographics, eating pathology, and exercise and then completed a 10-day Ecological Momentary Assessment (EMA) protocol assessing exercise amount and motives, body satisfaction, and DE symptoms via a mobile application. Those in the Fitbit condition wore a Fitbit over the entire assessment period.
RESULTS


The use of a Fitbit over a 10-day period had no significant effects on exercise behavior or body satisfaction compared to a control group. However, those in the Fitbit group were more likely to exercise to reach fitness goals and less likely to engage in dietary restraint and binge-eating behavior. Among participants in the Fitbit condition, steps achieved the previous day were not predictive of exercise engagement, body satisfaction, or DE symptoms on the subsequent day.
CONCLUSIONS


Our study failed to link fitness self-tracking to body dissatisfaction and DE, at least in the early stages of use. Future research directions regarding alternative pathways through which self-tracking devices may exert negative influences are discussed. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,The use of a Fitbit over a 10-day period had no significant effects on exercise behavior or body satisfaction compared to a control group.,"['262 participants who had never used a wearable fitness self-tracking device', 'adult women']","['Fitbit self-tracking', 'control condition']","['dietary restraint and binge-eating behavior', '10-day Ecological Momentary Assessment (EMA) protocol assessing exercise amount and motives, body satisfaction, and DE symptoms via a mobile application', 'exercise behavior or body satisfaction', 'exercise engagement, body satisfaction, or DE symptoms', 'state body satisfaction, disordered eating (DE; i.e., binge eating and dietary restraint), levels of exercise engagement, and motivations (appearance vs. fitness/health']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",262.0,0.0275696,The use of a Fitbit over a 10-day period had no significant effects on exercise behavior or body satisfaction compared to a control group.,"[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Gittus', 'Affiliation': 'Melbourne School of Psychological Sciences.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Fuller-Tyszkiewicz', 'Affiliation': 'Centre for Social and Early Emotional Development.'}, {'ForeName': 'Haley E', 'Initials': 'HE', 'LastName': 'Brown', 'Affiliation': 'Melbourne School of Psychological Sciences.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Richardson', 'Affiliation': 'School of Psychology.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Fassnacht', 'Affiliation': 'Research School of Psychology.'}, {'ForeName': 'Georgina R', 'Initials': 'GR', 'LastName': 'Lennard', 'Affiliation': 'Research School of Psychology.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Holland', 'Affiliation': 'School of Psychological Sciences.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Krug', 'Affiliation': 'School of Psychological Sciences.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000881']
877,32406728,A cluster randomized controlled trial of a positive physical activity intervention.,"OBJECTIVE


Due to global urbanization, technological advancements, and increasing convenience in daily activities, reduced energy expenditure in all aspects of life has become a major public health concern. A positive physical activity (PPA) intervention was developed to promote physical activity and fitness among Hong Kong families. PPA utilizes positive affective attitudes to circumvent barriers to health behavior change by helping families associate feelings of enjoyment with physical activity. Zero-Time Exercise (ZTEx) was introduced and promoted as a foot-in-the-door approach.
METHOD


Using a community-based collaborative approach, the research team worked with social service organizations, a government department, and schools to implement a cluster randomized controlled crossover trial at a citywide scale. A total of 1,983 eligible participants from 1,467 families were recruited from all 18 districts in Hong Kong. Data were collected using structured questionnaires and physical fitness assessments at preintervention and 1-month and 3-month follow-up.
RESULTS


PPA was effective in increasing ZTEx and ZTEx with family members at 1-month and 3-month follow-up and in improving balance and endurance at 3-month follow-up. Semistructured focus groups provided further support for the intervention effectiveness and added in-depth insights into the participants' motivational, interpersonal, and affective experiences.
CONCLUSION


The results not only shed light on the intervention's effectiveness for physical activity and fitness but also demonstrated that the community-based collaborative approach was successful in engaging relevant stakeholders in an active and fruitful partnership with effective capacity building for program development. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"RESULTS


PPA was effective in increasing ZTEx and ZTEx with family members at 1-month and 3-month follow-up and in improving balance and endurance at 3-month follow-up.","['Using a community-based collaborative approach', '1,983 eligible participants from 1,467 families were recruited from all 18 districts in Hong Kong']","['Zero-Time Exercise (ZTEx', 'positive physical activity (PPA) intervention', 'positive physical activity intervention', 'PPA']",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],1467.0,0.0423359,"RESULTS


PPA was effective in increasing ZTEx and ZTEx with family members at 1-month and 3-month follow-up and in improving balance and endurance at 3-month follow-up.","[{'ForeName': 'Henry C Y', 'Initials': 'HCY', 'LastName': 'Ho', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Moses Wai-Keung', 'Initials': 'MW', 'LastName': 'Mui', 'Affiliation': 'Hong Kong Council of Social Service.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Wan', 'Affiliation': 'School of Public Health.'}, {'ForeName': 'Carol Wing-See', 'Initials': 'CW', 'LastName': 'Yew', 'Affiliation': 'United Centre of Emotional Health and Positive Living.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000885']
878,31276981,Evaluating the addition of bevacizumab to endocrine therapy as first-line treatment for hormone receptor-positive metastatic breast cancer: a pooled analysis from the LEA (GEICAM/2006-11_GBG51) and CALGB 40503 (Alliance) trials.,"BACKGROUND


Randomised trials comparing the efficacy of standard endocrine therapy (ET) versus experimental ET + bevacizumab (Bev) in 1st line hormone receptor-positive patients with metastatic breast cancer have thus far shown conflicting results.
PATIENTS AND METHODS


We pooled data from two similar phase III randomised trials of ET ± Bev (LEA and Cancer and Leukemia Group B 40503) to increase precision in estimating treatment effect. Primary end-point was progression-free survival (PFS). Secondary end-points were overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR) and safety. Exploratory analyses were performed within subgroups defined by patients with recurrent disease, de novo disease, prior endocrine sensitivity or resistance and reported grades III-IV hypertension and proteinuria.
RESULTS


The pooled sample consisted of 749 patients randomised to ET or ET + Bev. Median PFS was 14.3 months for ET versus 19 months for ET + Bev (unadjusted hazard ratio [HR] 0.77; 95% confidence interval [CI] 0.66-0.91; p < 0.01). ORR and CBR with ET and ET + Bev were 40 versus 61% (p < 0.01) and 64 versus 77% (p < 0.01), respectively. There was no difference in OS (HR 0.96; 95% CI 0.77-1.18; p = 0.68). PFS was superior for ET + Bev for endocrine-sensitive patients (HR 0.68; 95% CI 0.53-0.89; p = 0.004). Grade III-IV hypertension (2.2 versus 20.1%), proteinuria (0 versus 9.3%), cardiovascular (0.5 versus 4.2%) and liver events (0 versus 2.9%) were significantly higher for ET + Bev (all p < 0.01). Hypertension and proteinuria were not predictors of efficacy (interaction test p = 0.33).
CONCLUSION


The addition of Bev to ET increased PFS overall and in endocrine-sensitive patients but not OS at the expense of significant additional toxicity.
TRIALS REGISTRATION


ClinicalTrial.Gov NCT00545077 and NCT00601900.",2019,PFS was superior for ET + Bev for endocrine-sensitive patients (HR 0.68; 95% CI 0.53-0.89; p = 0.004).,"['We pooled data from two similar phase III randomised trials of ET\xa0±', '1st line hormone receptor-positive\xa0patients with metastatic breast cancer', '749 patients randomised to ET or ET\xa0+\xa0Bev', 'patients with recurrent disease, de novo disease, prior endocrine sensitivity or resistance\xa0and reported grades III-IV hypertension and proteinuria', 'hormone receptor-positive metastatic breast cancer']","['standard endocrine therapy (ET) versus experimental ET\xa0+\xa0bevacizumab (Bev', 'bevacizumab']","['Grade III-IV hypertension', 'progression-free survival (PFS', 'Hypertension and proteinuria', 'OS', 'proteinuria', 'Bev ', 'ORR and CBR with ET and ET', 'overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR) and safety', 'cardiovascular', 'liver events', 'Median PFS']","[{'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205435', 'cui_str': 'First (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease (disorder)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.14133,PFS was superior for ET + Bev for endocrine-sensitive patients (HR 0.68; 95% CI 0.53-0.89; p = 0.004).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Martín', 'Affiliation': 'Medical Oncology, Instituto de Investigación Sanitaria Gregorio Marañón, Universidad Complutense Madrid, Centro de Investigación Biomédica en Red de Oncología, CIBERONC-ISCIII, GEICAM Spanish Breast Cancer Group, Spain. Electronic address: mmartín@geicam.org.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'GBG (German Breast Group), Neu-Isenburg, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hyslop', 'Affiliation': 'Alliance Statistics and Data Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'De la Haba-Rodríguez', 'Affiliation': 'Oncology Department and Research Unit, Instituto Maimónides de Investigación Biomédica de Córdoba, Hospital Reina Sofía, Universidad de Córdoba Spain. Centro de Investigación Biomédica en Red de Oncología, CIBERONC-ISCIII, GEICAM Spanish Breast Cancer Group, Spain.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Aktas', 'Affiliation': ""University Women's Hospital Leipzig, Leipzig, Germany.""}, {'ForeName': 'C T', 'Initials': 'CT', 'LastName': 'Cirrincione', 'Affiliation': 'Alliance Statistics and Data Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Mehta', 'Affiliation': 'GBG (German Breast Group), Neu-Isenburg, Germany.'}, {'ForeName': 'W T', 'Initials': 'WT', 'LastName': 'Barry', 'Affiliation': 'Alliance Statistics and Data Center, Dana-Farber/Partners Cancer Care, Boston, MA, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Morales', 'Affiliation': 'Medical Oncology, Hospital Arnau de Vilanova de Lérida, GEICAM Spanish Breast Cancer Group, Spain.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Carey', 'Affiliation': 'University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Garcia-Saenz', 'Affiliation': 'Medical Oncology, Instituto de Investigación Sanitaria del Hospital Clinico San Carlos (IdISSC) Madrid, Centro de Investigación Biomédica en Red de Oncología, CIBERONC-ISCIII, GEICAM Spanish Breast Cancer Group, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Partridge', 'Affiliation': 'Dana-Farber/Partners CancerCare, Boston, MA, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Martinez-Jañez', 'Affiliation': 'Medical Oncology. Universitary Hospital Ramon y Cajal. GEICAM, Spanish Breast Cancer Group; Madrid, Spain.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Hahn', 'Affiliation': 'Alliance Protocol Operations Office, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Winer', 'Affiliation': 'Dana-Farber/Partners CancerCare, Boston, MA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Guerrero-Zotano', 'Affiliation': 'Medical Oncology. Valencian Institute of Oncology. GEICAM Spanish Breast Cancer Group, Valencia, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hudis', 'Affiliation': 'American Society of Clinical Oncology (ASCO), Alexandria, VA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Casas', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rodriguez-Martin', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Furlanetto', 'Affiliation': 'GBG (German Breast Group), Neu-Isenburg, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Carrasco', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Dickler', 'Affiliation': 'Eli Lilly and Co. Indianapolis, IN, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.06.002']
879,31314952,Nerve growth factor-induced muscle hyperalgesia facilitates ischaemic contraction-evoked pain.,"BACKGROUND


Intramuscular injection of Nerve Growth Factor (NGF) may influence the responsiveness of active chemo-sensitive channels affecting muscle pain sensitivity. This double-blinded crossover study in healthy humans assessed contraction-evoked pain responses and pain sensitivity during acute ischaemia in the tibialis anterior (TA) muscle before and 24 hr after five distributed NGF injections (1 µg, 4 cm interval) compared with control injections (isotonic-saline).
METHODS


Twenty-one subjects participated in two experimental phases, each including five sessions over 7 days, with a gap of 4 weeks in-between. Muscle pain intensity evoked with daily functional tasks (Likert scale score) was collected using a paper diary. Pain intensity evoked by ischaemic and non-ischaemic contractions numerical rating scale (NRS) was collected at Day0 and Day1. Pressure pain thresholds (PPTs) on the TA were recorded before (Day0), 3 hr, 1, 3, and 7 days post-injection, and after the ischaemic-contractions and post-cuff deflation at Day0 and Day1.
RESULTS


Increased Likert scores of pain were present for 7 days after NGF compared to control injections (p < .05). Higher NRS pain scores of ischaemic-contractions were seen when contracting the muscle injected with NGF compared to baseline (p = .003) and control (p = .012). Pain during non-ischaemic contractions was not significantly affected by NGF injections. Decreased PPTs were found at 3 hr, Day1 and Day3 post-injection (p < .05) in both conditions. Compared with pre-contractions, PPTs were increased following ischaemic contractions at Day0 (p < .05) and Day1 (p < .05) in both conditions.
CONCLUSION


This study showed that ischaemic contraction-evoked pain was facilitated in an NGF-sensitized muscle.
SIGNIFICANCE


Acidification of the muscle environment may affect muscle nociceptors and pain by different mechanisms, including activation of ASIC 3  and TRPV1. In this study, pain evoked following ischaemic contractions was increased in the Nerve Growth Factor (NGF)-sensitized muscle compared with non-ischaemic contractions and in the non-sensitized muscle. These findings illustrate that responses of peripheral afferents under ischaemic conditions are altered by a pre-sensitized muscle. This highlights the role of growth factors, including NGF, in peripheral muscle sensitization with clinical implications for ischaemic myalgia.",2019,"RESULTS


Increased Likert scores of pain were present for 7 days after NGF compared to control injections (p < .05).","['healthy humans assessed', 'Twenty-one subjects participated in two experimental phases, each including five sessions over 7\xa0days, with a gap of 4\xa0weeks in-between']","['control injections (isotonic-saline', 'Nerve Growth Factor (NGF']","['Higher NRS pain scores of ischaemic-contractions', 'contraction-evoked pain responses and pain sensitivity', 'ischaemic contraction-evoked pain', 'Likert scores of pain', 'Muscle pain intensity evoked with daily functional tasks (Likert scale score', 'Pressure pain thresholds (PPTs', 'Decreased PPTs', 'Pain', 'pain evoked following ischaemic contractions', 'Pain intensity evoked by ischaemic and non-ischaemic contractions numerical rating scale (NRS']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}]",21.0,0.0926177,"RESULTS


Increased Likert scores of pain were present for 7 days after NGF compared to control injections (p < .05).","[{'ForeName': 'Line Bay', 'Initials': 'LB', 'LastName': 'Sørensen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Gazerani', 'Affiliation': 'Biomedicine, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Graven-Nielsen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}]","European journal of pain (London, England)",['10.1002/ejp.1455']
880,31523904,Evaluation of the effects of sodium-glucose co-transporter 2 inhibition with empagliflozin on morbidity and mortality in patients with chronic heart failure and a preserved ejection fraction: rationale for and design of the EMPEROR-Preserved Trial.,"BACKGROUND


The principal biological processes that characterize heart failure with a preserved ejection fraction (HFpEF) are systemic inflammation, epicardial adipose tissue accumulation, coronary microcirculatory rarefaction, myocardial fibrosis and vascular stiffness; the resulting impairment of left ventricular and aortic distensibility (especially when accompanied by impaired glomerular function and sodium retention) causes increases in cardiac filling pressures and exertional dyspnoea despite the relative preservation of left ventricular ejection fraction. Independently of their actions on blood glucose, sodium-glucose co-transporter 2 (SGLT2) inhibitors exert a broad range of biological effects (including actions to inhibit cardiac inflammation and fibrosis, antagonize sodium retention and improve glomerular function) that can ameliorate the pathophysiological derangements in HFpEF. Such SGLT2 inhibitors exert favourable effects in experimental models of HFpEF and have been found in large-scale trials to reduce the risk for serious heart failure events in patients with type 2 diabetes, many of whom were retrospectively identified as having HFpEF.
STUDY DESIGN


The EMPEROR-Preserved Trial is enrolling ≈5750 patients with HFpEF (ejection fraction >40%), with and without type 2 diabetes, who are randomized to receive placebo or empagliflozin 10 mg/day, which is added to all appropriate treatments for HFpEF and co-morbidities.
STUDY AIMS


The primary endpoint is the time-to-first-event analysis of the combined risk for cardiovascular death or hospitalization for heart failure. The trial will also evaluate the effects of empagliflozin on renal function, cardiovascular death, all-cause mortality and recurrent hospitalization events, and will assess a wide range of biomarkers that reflect important pathophysiological mechanisms that may drive the evolution of HFpEF. The EMPEROR-Preserved Trial is well positioned to determine if empagliflozin can have a meaningful impact on the course of HFpEF, a disorder for which there are currently few therapeutic options.",2019,"The EMPEROR-Preserved Trial is well positioned to determine if empagliflozin can have a meaningful impact on the course of HFpEF, a disorder for which there are currently few therapeutic options.","['patients with type\u20092 diabetes', 'patients with chronic heart failure and a preserved ejection fraction', '≈5750 patients with HFpEF']","['placebo or empagliflozin', 'sodium-glucose co-transporter 2 inhibition with empagliflozin', 'empagliflozin']","['time-to-first-event analysis of the combined risk for cardiovascular death or hospitalization for heart failure', 'morbidity and mortality', 'renal function, cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",,0.0591386,"The EMPEROR-Preserved Trial is well positioned to determine if empagliflozin can have a meaningful impact on the course of HFpEF, a disorder for which there are currently few therapeutic options.","[{'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK) and Berlin Institute of Health Centre for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) Partner Site, Berlin, Germany.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'University of Mississippi School of Medicine, Jackson, MI, USA.'}, {'ForeName': 'Gerasimos S', 'Initials': 'GS', 'LastName': 'Filippatos', 'Affiliation': 'School of Medicine, National and Kapodistrian University of Athens, Athens University Hospital Attikon, Athens, Greece.'}, {'ForeName': 'Waheed', 'Initials': 'W', 'LastName': 'Jamal', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Salsali', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Schnee', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Boehringer Ingelheim Canada Ltd, Burlington, ON, Canada.'}, {'ForeName': 'Cordula', 'Initials': 'C', 'LastName': 'Zeller', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Jyothis', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'Inserm INI-CRCT, CHRU, University of Lorraine, Nancy, France.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1596']
881,31944270,Iontophoretic delivery of methotrexate in the treatment of palmar psoriasis: A randomised controlled study.,"BACKGROUND/OBJECTIVES


Palmoplantar psoriasis is a localised variant of psoriasis. Topical therapy is the preferred treatment modality, but in severe and recalcitrant cases, systemic drugs like methotrexate are prescribed, with potential for significant adverse effects. Iontophoresis is gaining popularity in enhancing the transdermal delivery of drugs in ionic state. This study was undertaken to evaluate and compare the efficacy of topical methotrexate by iontophoresis technique with clobetasol propionate 0.05% ointment in the treatment of palmar psoriasis.
METHODS


This was a prospective randomised controlled study conducted on patients with palmar psoriasis. Group 1 patients (n = 31) were treated with once weekly iontophoretic delivery of methotrexate over 6 sittings, and group 2 patients (n = 31) were treated with clobetasol propionate 0.05% ointment, twice daily for 6 weeks. Severity of palmar psoriasis was assessed by modified Palmoplantar Pustular Psoriasis Area and Severity Index (m-PPPASI), and treatment was considered as satisfactory when there was >50% improvement.
RESULTS


Sixty two patients were recruited, of which 50 completed the study. Eight out of 25 (32%) patients in group 1 and 12 out of 25 (48%) patients in group 2 showed satisfactory improvement at the end of 6 weeks. However, this difference was statistically not significant (P = 0.25). Burn injury was noted in 12 (48%) group 1 patients with no adverse effects in group 2.
CONCLUSION


Iontophoretic delivery of methotrexate is a promising therapeutic modality, the efficacy of which is comparable to that of clobetasol propionate ointment in the treatment of palmar psoriasis.",2020,"Burn injury was noted in 12 (48%) group 1 patients with no adverse effects in group 2.
CONCLUSION


","['patients with palmar psoriasis', 'palmar psoriasis', 'Sixty two patients were recruited, of which 50 completed the study']","['clobetasol propionate 0.05% ointment', 'Topical therapy', 'methotrexate', 'clobetasol propionate ointment', 'topical methotrexate']","['Severity of palmar psoriasis', 'satisfactory improvement', 'modified Palmoplantar Pustular Psoriasis Area and Severity Index (m-PPPASI', 'Burn injury']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1184147', 'cui_str': 'Palmar (qualifier value)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0055895', 'cui_str': 'Clobetasol Propionate'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1184147', 'cui_str': 'Palmar (qualifier value)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0030246', 'cui_str': 'Pustulosis of Palms and Soles'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006434', 'cui_str': 'Burns'}]",50.0,0.0385666,"Burn injury was noted in 12 (48%) group 1 patients with no adverse effects in group 2.
CONCLUSION


","[{'ForeName': 'Naveen Kumar', 'Initials': 'NK', 'LastName': 'Andanooru Chandrappa', 'Affiliation': 'Department of D.V.L, Hassan Institute of Medical Sciences, Hassan, Karnataka, India.'}, {'ForeName': 'Banavase', 'Initials': 'B', 'LastName': 'Channakeshavaiah Ravikumar', 'Affiliation': 'Department of D.V.L, Hassan Institute of Medical Sciences, Hassan, Karnataka, India.'}, {'ForeName': 'Suresh Mahadevarahalli', 'Initials': 'SM', 'LastName': 'Rangegowda', 'Affiliation': 'Department of D.V.L, Hassan Institute of Medical Sciences, Hassan, Karnataka, India.'}]",The Australasian journal of dermatology,['10.1111/ajd.13228']
882,31944277,Characterisation of the inflammatory response triggered by topical ingenol mebutate 0.05% gel in basal cell carcinoma.,"BACKGROUND/OBJECTIVE


Ingenol mebutate gel is approved for actinic keratosis field therapy, but little has been published as a treatment of basal cell carcinoma (BCC). Our objective is to characterise the histopathological changes and the infiltrating cell populations to better understand its mechanism of action.
METHODS


Sixteen patients with various BCC subtypes were prospectively evaluated and treated once daily for two consecutive days with ingenol mebutate gel 0.05% under occlusion. Patients were randomised to two arms: the first arm was biopsied between the third and the tenth day after treatment initiation ('early immune response'), and the second arm was biopsied at day 30 after treatment initiation ('late immune response'). The immunopathology was evaluated by immunohistochemistry: anti-CD3, anti-CD4, anti-CD8, anti-CD20, anti-CD56, anti-CD68, anti-Bcl-2, anti-CASP3, anti-FoxP3, anti-GrzB and anti-TIA-1.
RESULTS


Ten BCCs were in complete remission after 2 years of follow-up. The early immune response was characterised by a quick recruitment of T lymphocytes, macrophages and natural killer cells. At later time-points, T-regulatory cells and some pro-apoptotic markers were detected. Treatment-related adverse events were described.
CONCLUSION


Ingenol mebutate gel produces a transient immuno-inflammatory response and an important necrosis reaction in BCCs. Larger studies will be required to determine the maximum effective tolerated dose of ingenol mebutate gel for BCC.",2020,"Treatment-related adverse events were described.
",['Sixteen patients with various BCC subtypes'],['ingenol mebutate gel 0.05% under occlusion'],"['quick recruitment of T lymphocytes, macrophages and natural killer cells']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}]","[{'cui': 'C2825682', 'cui_str': 'ingenol mebutate'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0024432', 'cui_str': 'Monocyte-Derived Macrophages'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}]",,0.0248902,"Treatment-related adverse events were described.
","[{'ForeName': 'Mª Reyes', 'Initials': 'MR', 'LastName': 'García-de-la-Fuente', 'Affiliation': 'Department of Dermatology, University Hospital Arnau de Vilanova, Lleida, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Santacana', 'Affiliation': 'Lleida Institute for Biomedical Research Dr. Pifarré Foundation (IRBLleida), Lleida, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Verdaguer', 'Affiliation': 'Lleida Institute for Biomedical Research Dr. Pifarré Foundation (IRBLleida), Lleida, Spain.'}, {'ForeName': 'Felip', 'Initials': 'F', 'LastName': 'Vilardell', 'Affiliation': 'Department of Pathology, University Hospital Arnau de Vilanova, Lleida, Spain.'}, {'ForeName': 'Eloi', 'Initials': 'E', 'LastName': 'Garí', 'Affiliation': 'Lleida Institute for Biomedical Research Dr. Pifarré Foundation (IRBLleida), Lleida, Spain.'}, {'ForeName': 'Josep Manel', 'Initials': 'JM', 'LastName': 'Casanova', 'Affiliation': 'Department of Dermatology, University Hospital Arnau de Vilanova, Lleida, Spain.'}]",The Australasian journal of dermatology,['10.1111/ajd.13229']
883,31912434,"A Randomized, Double-Blind, Placebo-Controlled Trial of Ibuprofen Lysinate in Comparison to Ibuprofen Acid for Acute Postoperative Dental Pain.","INTRODUCTION


Ibuprofen acid is poorly soluble in the stomach, thus reaching maximum plasma levels at approximately 90 min post-dose. Ibuprofen lysinate has been developed to accelerate absorption of ibuprofen to shorten the time to analgesic efficacy. This study compared analgesic efficacy and onset of effect of a single dose of ibuprofen lysinate or ibuprofen acid in patients undergoing third molar extraction.
METHODS


Randomized, double-blind, placebo-controlled, multi-center, parallel-group single-dose study. Adults (18-60 years) undergoing extraction of ≥ 1 third molar were randomized 2:2:1 to ibuprofen lysinate, ibuprofen acid, or placebo postoperatively. Pain relief (PAR, 5-point scale, 0 = none to 4 = complete pain relief) and pain intensity (PI, 100 mm visual analog scale) were assessed between 15 and 360 min post-dose. The primary endpoint was the weighted sum of PAR scores at 6 h (TOTPAR). Time to onset of effect, global assessment of efficacy, and adverse events were also assessed.
RESULTS


Overall, 351 patients received ibuprofen lysinate (N = 141), ibuprofen acid (N = 139), or placebo (N = 71). Both active treatments significantly reduced pain compared with placebo, from 15 min post-dose to 6 h (TOTPAR: ibuprofen lysinate: 19.57; ibuprofen acid: 19.96; placebo: 8.27). Ibuprofen lysinate was significantly more effective than placebo, but non-inferior to ibuprofen acid, at providing pain relief over 6 h. There was no significant difference between ibuprofen lysinate and ibuprofen acid for onset of analgesia. Both ibuprofen formulations were well tolerated; all adverse events were mild to moderate and considered unrelated to treatment.
CONCLUSIONS


A single dose of ibuprofen lysinate is non-inferior to ibuprofen acid in terms of analgesic efficacy, onset of action, and tolerability in patients who have recently undergone dental surgery.
TRIAL REGISTRATION


EudraCT No. 2006-006942-33. Plain language summary available for this article.",2020,"Ibuprofen lysinate was significantly more effective than placebo, but non-inferior to ibuprofen acid, at providing pain relief over 6 h.","['patients undergoing third molar extraction', 'patients who have recently undergone dental surgery', '2006', 'Adults (18-60\xa0years) undergoing extraction of\u2009≥\u20091 third molar', 'Acute Postoperative Dental Pain', '351 patients received']","['Ibuprofen Lysinate', 'Placebo', 'ibuprofen lysinate or ibuprofen acid', 'ibuprofen', 'ibuprofen acid', 'ibuprofen lysinate', 'Ibuprofen lysinate', 'placebo', 'EudraCT', 'Ibuprofen acid', 'Ibuprofen Acid', 'ibuprofen lysinate, ibuprofen acid, or placebo']","['pain relief', 'weighted sum of PAR scores at 6\xa0h (TOTPAR', 'Time to onset of effect, global assessment of efficacy, and adverse events', 'Pain relief (PAR, 5-point scale, 0\u2009=\u2009none to 4\u2009=\u2009complete pain relief) and pain intensity (PI, 100\xa0mm visual analog scale', 'pain', 'analgesic efficacy, onset of action, and tolerability', 'tolerated; all adverse events', 'analgesic efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0204324', 'cui_str': 'Dental surgical procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0074814', 'cui_str': 'solufenum'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0001128', 'cui_str': 'Acids'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0222045'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}]",351.0,0.64321,"Ibuprofen lysinate was significantly more effective than placebo, but non-inferior to ibuprofen acid, at providing pain relief over 6 h.","[{'ForeName': 'Ján', 'Initials': 'J', 'LastName': 'Kyselovič', 'Affiliation': 'Clinical Research Unit, 5th Department of Internal Medicine, Medical Faculty of Comenius University, University Hospital, Bratislava, Slovak Republic.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Koscova', 'Affiliation': 'CHC Medical Affairs, Eastern Europe Zone, Sanofi-Aventis Pharma Slovakia s.r.o, Bratislava, Slovak Republic.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Lampert', 'Affiliation': 'Medical CHC, Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Weiser', 'Affiliation': 'Medical CHC, Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany. thomas.weiser@sanofi.com.'}]",Pain and therapy,['10.1007/s40122-019-00148-1']
884,31925317,A randomised phase II trial of hydroxychloroquine and imatinib versus imatinib alone for patients with chronic myeloid leukaemia in major cytogenetic response with residual disease.,"In chronic-phase chronic myeloid leukaemia (CP-CML), residual BCR-ABL1+ leukaemia stem cells are responsible for disease persistence despite TKI. Based on in vitro data, CHOICES (CHlorOquine and Imatinib Combination to Eliminate Stem cells) was an international, randomised phase II trial designed to study the safety and efficacy of imatinib (IM) and hydroxychloroquine (HCQ) compared with IM alone in CP-CML patients in major cytogenetic remission with residual disease detectable by qPCR. Sixty-two patients were randomly assigned to either arm. Treatment 'successes' was the primary end point, defined as ≥0.5 log reduction in 12-month qPCR level from trial entry. Selected secondary study end points were 24-month treatment 'successes', molecular response and progression at 12 and 24 months, comparison of IM levels, and achievement of blood HCQ levels >2000 ng/ml. At 12 months, there was no difference in 'success' rate (p = 0.58); MMR was achieved in 80% (IM) vs 92% (IM/HCQ) (p = 0.21). At 24 months, the 'success' rate was 20.8% higher with IM/HCQ (p = 0.059). No patients progressed. Seventeen serious adverse events, including four serious adverse reactions, were reported; diarrhoea occurred more frequently with combination. IM/HCQ is tolerable in CP-CML, with modest improvement in qPCR levels at 12 and 24 months, suggesting autophagy inhibition maybe of clinical value in CP-CML.",2020,"At 12 months, there was no difference in 'success' rate (p = 0.58); MMR was achieved in 80% (IM) vs 92% (IM/HCQ) (p = 0.21).","['2000', 'CP-CML patients in major cytogenetic remission with residual disease detectable by qPCR', 'patients with chronic myeloid leukaemia in major cytogenetic response with residual disease', 'Sixty-two patients']","['hydroxychloroquine and imatinib versus imatinib alone', 'IM/HCQ', 'imatinib (IM) and hydroxychloroquine (HCQ']","['MMR', 'diarrhoea', ""24-month treatment 'successes', molecular response and progression at 12 and 24 months, comparison of IM levels, and achievement of blood HCQ levels"", 'qPCR levels', ""success' rate""]","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4055168', 'cui_str': 'Cytogenetic response'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",62.0,0.0257648,"At 12 months, there was no difference in 'success' rate (p = 0.58); MMR was achieved in 80% (IM) vs 92% (IM/HCQ) (p = 0.21).","[{'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Horne', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stobo', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mukhopadhyay', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Latif', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dixon-Hughes', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'McMahon', 'Affiliation': 'Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Cony-Makhoul', 'Affiliation': 'Haematology department, CH Annecy-Genevois, Pringy, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Byrne', 'Affiliation': 'Department of Haematology, Nottingham City Hospital, Nottingham, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Smith', 'Affiliation': ""Department of Haematology, St James's University Hospital, Leeds, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Koschmieder', 'Affiliation': 'Department of Medicine (Hematology Oncology, Hemostaseology, and Stem Cell Transplantation), Faculty of Medicine, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'BrÜmmendorf', 'Affiliation': 'Department of Medicine (Hematology Oncology, Hemostaseology, and Stem Cell Transplantation), Faculty of Medicine, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schafhausen', 'Affiliation': 'Department of Internal Medicine, University Medical Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gallipoli', 'Affiliation': 'Centre for Haemato-Oncology, Barts Cancer Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Thomson', 'Affiliation': 'Experimental therapeutics, Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Cong', 'Affiliation': 'Experimental therapeutics, Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Clark', 'Affiliation': 'Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Milojkovic', 'Affiliation': 'Department of Haematology, Hammersmith Hospital, London, UK.'}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Helgason', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Foroni', 'Affiliation': 'Department of Haematology, Imperial College London, London, UK.'}, {'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'Nicolini', 'Affiliation': 'Hématologie Clinique and INSERM U1052, CRCL, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Holyoake', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Copland', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK. Mhairi.Copland@glasgow.ac.uk.""}]",Leukemia,['10.1038/s41375-019-0700-9']
885,31250427,The MedSafer Study: A Controlled Trial of an Electronic Decision Support Tool for Deprescribing in Acute Care.,"OBJECTIVES


Polypharmacy is common, costly, and harmful for hospitalized older adults. Scalable strategies to reduce the burden of potentially inappropriate medications (PIMs) are needed. We sought to leverage medication reconciliation in hospitalized older adults by pairing with MedSafer, an electronic decision support tool for deprescribing.
DESIGN


This was a nonrandomized controlled before-and-after study.
SETTING


The study took place on four internal medicine clinical teaching units.
PARTICIPANTS


Subjects were aged 65 years and older, had an expected prognosis of 3 or more months, and were taking five or more usual home medications.
INTERVENTION


In the baseline phase, patients received usual care that was medication reconciliation. Patients in the intervention arm also had a ""deprescribing opportunity report"" generated by MedSafer and provided to their in-hospital treating team.
MEASUREMENTS


The primary outcome was ascertained at the time of hospital discharge and was the proportion of patients who had one or more PIMs deprescribed.
RESULTS


A total of 1066 patients were enrolled, and deprescribing opportunities were present for 873 (82%; 418 during the control and 455 during the intervention phases, respectively). The proportion of patients with one or more PIMs deprescribed at discharge increased from 46.9% in the control period to 54.7% in the intervention period with an adjusted absolute risk difference of 8.3% (2.9%-13.9%). Not all classes of drugs in the intervention arm were associated with an increase in deprescribing, and new PIM starts were equally common in both arms of the study.
CONCLUSION


Using an electronic decision support tool for deprescribing, we increased the proportion of patients with one or more PIMs deprescribed at hospital discharge as compared with usual care. Although this type of intervention may help address medication overload in hospitalized patients, it also underscores the importance of powering future trials for a reduction in adverse drug events.
TRIAL REGISTRATION


NCT02918058. J Am Geriatr Soc 67:1843-1850, 2019.",2019,"Not all classes of drugs in the intervention arm were associated with an increase in deprescribing, and new PIM starts were equally common in both arms of the study.
","['Subjects were aged 65\u2009years and older, had an expected prognosis of 3 or more months, and were taking five or more usual home medications', '1066 patients were enrolled, and deprescribing opportunities were present for 873 (82%; 418 during the control and 455 during the intervention phases, respectively', 'Deprescribing in Acute Care', 'hospitalized older adults', 'hospitalized patients']",[],"['increase in deprescribing, and new PIM starts', 'time of hospital discharge and was the proportion of patients who had one or more PIMs deprescribed', 'proportion of patients with one or more PIMs deprescribed at discharge']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4046040', 'cui_str': 'Deprescribing'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4046040', 'cui_str': 'Deprescribing'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}]",1066.0,0.041767,"Not all classes of drugs in the intervention arm were associated with an increase in deprescribing, and new PIM starts were equally common in both arms of the study.
","[{'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Wu', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Rashidi', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Forster', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Huang', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Pilote', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Papillon-Ferland', 'Affiliation': 'Department of Pharmacy, McGill University Health Centre, Montréal, Québec, Canada.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Bonnici', 'Affiliation': 'Department of Pharmacy, McGill University Health Centre, Montréal, Québec, Canada.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Tamblyn', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Whitty', 'Affiliation': 'Leslie L. Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Porter', 'Affiliation': 'Leslie L. Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Battu', 'Affiliation': 'Leslie L. Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Downar', 'Affiliation': 'Division of Palliative Care, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, McGill University, Montréal, Québec, Canada.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16040']
886,31309699,The Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial: baseline characteristics.,"BACKGROUND


The aims of this study were to: (i) report the baseline characteristics of patients enrolled in the Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial, (ii) compare DAPA-HF patients to participants in contemporary heart failure (HF) registries and in other recent HF trials, and (iii) compare individuals with diabetes, pre-diabetes and a normal glycated haemoglobin (HbA1c) in DAPA-HF.
METHODS AND RESULTS


Adults with HF in New York Heart Association functional class ≥ II, a left ventricular ejection fraction ≤ 40%, an elevated N-terminal pro-B-type natriuretic peptide concentration and receiving standard treatment were eligible for DAPA-HF, which is comparing dapagliflozin 10 mg once daily to matching placebo. In patients without a history of diabetes, previously undiagnosed diabetes was defined as a confirmed HbA1c ≥ 6.5%. Among patients without known or undiagnosed diabetes, pre-diabetes was defined as a HbA1c ≥ 5.7% The remainder of patients, with a HbA1c < 5.7%, were defined as normoglycaemic. Of the 4744 patients (mean age 66 years; 23% women) randomized, 42% had known diabetes and 3% undiagnosed diabetes. Of the remainder, 67% had pre-diabetes and 33% normal HbA1c. Overall, DAPA-HF patients were generally similar to those in recent registries and in relevant trials and had high levels of background therapy: 94% angiotensin-converting enzyme inhibitor/angiotensin receptor blocker/angiotensin receptor-neprilysin inhibitor, 96% beta-blocker, and 71% mineralocorticoid receptor antagonist; 26% had a defibrillator. Patients with diabetes had worse HF status, more co-morbidity, and greater renal impairment but received similar HF therapy. Patients with diabetes received non-insulin hypoglycaemic therapy alone in 49%, insulin alone in 11%, both in 14%, and none in 26%.
CONCLUSIONS


Patients randomized in DAPA-HF were similar to those in other contemporary HF with reduced ejection fraction (HFrEF) registries and trials. These patients were receiving recommended HFrEF therapy and those with diabetes were also treated with conventional glucose-lowering therapy. Consequently, DAPA-HF will test the incremental efficacy and safety of dapagliflozin in HFrEF patients with and without diabetes.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT03036124.",2019,"Patients with diabetes had worse HF status, more co-morbidity, and greater renal impairment but received similar HF therapy.","['Adults with HF in New York Heart Association functional class ≥\u2009II, a left ventricular ejection fraction ≤\u200940%, an elevated N-terminal pro-B-type natriuretic peptide concentration and receiving standard treatment were eligible for DAPA-HF, which is comparing dapagliflozin 10', 'HFrEF patients with and without diabetes', 'patients to participants in contemporary heart failure (HF) registries and in other recent HF trials, and (iii) compare individuals with diabetes, pre-diabetes and a normal glycated haemoglobin (HbA1c) in DAPA-HF', 'patients enrolled in the Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial', '4774 patients (mean age 66\u2009years; 23% women) randomized, 42% had known diabetes and 3% undiagnosed diabetes', 'Patients with diabetes received non']","['insulin alone', 'placebo', 'insulin hypoglycaemic therapy', 'angiotensin-converting enzyme inhibitor/angiotensin receptor blocker/angiotensin receptor-neprilysin inhibitor', 'dapagliflozin', 'DAPA-HF', 'HFrEF therapy', 'conventional glucose-lowering therapy']","['co-morbidity', 'renal impairment']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor (substance)'}, {'cui': 'C0025250', 'cui_str': 'CALLA Antigen'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}]",4774.0,0.157524,"Patients with diabetes had worse HF status, more co-morbidity, and greater renal impairment but received similar HF therapy.","[{'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'DeMets', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'National University of Cordoba, Cordoba, Argentina.'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1548']
887,31837079,Improved Display of Hepatic Arterial Anatomy Using Differential Subsampling With Cartesian Ordering (DISCO) With Gadoxetic Acid-Enhanced MRI: Comparison With Single Arterial Phase MRI and Computed Tomographic Angiography.,"BACKGROUND


In clinical practice arterial anatomy evaluation is often determined using computed tomographic angiography (CTA); the effect of enhanced MRI has been neglected.
PURPOSE


To evaluate whether multiple arterial phase (MAP) images from patients who underwent differential subsampling with Cartesian ordering (DISCO) acquisition would improve the hepatic arterial display compared with single arterial phase (SAP) and CTA.
STUDY TYPE


A prospective, randomized trial.
SUBJECTS


In all, 130 patients (mean age, 55.81 ± 9.43 years; range, 35-78 years) including 89 men and 41 women.
FIELD STRENGTH/SEQUENCE


3.0T, DISCO, liver acquisition with volume acceleration-flexible (LAVA-Flex), CTA.
ASSESSMENT


A simple randomization was conducted and the study was subdivided into study part I (DISCO vs. SAP) and study part II (DISCO vs. CTA). Ten hepatic arterial segments were independently evaluated by three readers in the axial plane and the quality of hepatic arterial display was assessed using a four-point scale.
STATISTICAL TESTS


Kendall's W-test, χ 2  test, Mann-Whitney U-test, and Kruskal-Wallis one-way analysis of variance (ANOVA) test.
RESULTS


Excellent interobserver agreement was obtained for hepatic arterial display (all Kendall's W values >0.80). For study part I, the mean arterial display scores for the common hepatic artery (CHA), proper hepatic artery (PHA), left hepatic artery (LHA), right hepatic artery (RHA), left gastric artery (LGA), and gastroduodenal artery (GDA) obtained with DISCO were higher than that obtained with SAP imaging (all P < 0.01). For study part II, comparable image quality for CHA (P = 0.798), PHA (P = 0.440), LHA (P = 0.211), RHA (P = 0.775) LGA (P = 0.468), and GDA (P = 0.801) was obtained with DISCO and CTA.
DATA CONCLUSION


The use of MAP acquisition with DISCO is superior to the use of SAP in hepatic arterial display and compares favorably with CTA; in the future, DISCO possibly can replace the latter ionization-related method to provide a more comprehensive evaluation of the liver arterial vessels.
LEVEL OF EVIDENCE


1 Technical Efficacy Stage: 1 J. Magn. Reson. Imaging 2020;51:1766-1776.",2020,Excellent interobserver agreement was obtained for hepatic arterial display (all Kendall's W values >0.80).,"['In all, 130 patients (mean age, 55.81\u2009±\u20099.43\u2009years; range, 35-78\u2009years) including 89 men and 41 women', 'patients who underwent differential subsampling with Cartesian ordering (DISCO) acquisition']","['Differential Subsampling With Cartesian Ordering (DISCO', 'liver acquisition with volume acceleration-flexible (LAVA-Flex), CTA', 'Gadoxetic Acid-Enhanced MRI', 'computed tomographic angiography (CTA', 'Single Arterial Phase MRI and Computed Tomographic Angiography']","['hepatic arterial display', 'quality of hepatic arterial display', 'mean arterial display scores for the common hepatic artery (CHA), proper hepatic artery (PHA), left hepatic artery (LHA), right hepatic artery (RHA), left gastric artery (LGA), and gastroduodenal artery (GDA) obtained with DISCO']","[{'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}]","[{'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C3489483', 'cui_str': 'Gadoxetic acid'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0226300', 'cui_str': 'Structure of common hepatic artery'}, {'cui': 'C0019145', 'cui_str': 'Hepatic artery (body structure)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0226298', 'cui_str': 'Left Gastric Artery'}, {'cui': 'C0226311', 'cui_str': 'Structure of gastroduodenal artery'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}]",130.0,0.0315587,Excellent interobserver agreement was obtained for hepatic arterial display (all Kendall's W values >0.80).,"[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Guoyong', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Hehan', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zixing', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiaopeng', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiaocheng', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'GE Healthcare China, Beijing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Song', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.27020']
888,31852021,A self-help intervention for reducing time to diagnosis in Indonesian women with breast cancer symptoms.,"OBJECTIVE


We investigated the effectiveness of a self-help intervention named PERANTARA, which aims to improve adherence to diagnostic procedures among women with breast cancer (BC) symptoms to reduce the time to a definitive diagnosis.
METHODS


With a cluster randomized crossover design across four hospitals, PERANTARA and treatment as usual (TAU) or TAU only was provided at successive periods in a randomly determined order. The main outcome was the time between the first medical consultation and the definitive diagnosis. Secondary outcomes were BC knowledge, measured by the Breast Cancer Knowledge Test (BCKT); symptoms of anxiety and depression, measured by the Hospital Anxiety and Depression Scale (HADS); quality of life, measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF); and health status, measured by the EQ-5D-5L. A linear mixed model analysis was conducted to analyse the outcomes.
RESULTS


We recruited 132 women with BC symptoms from four hospitals; 67 participants were in the intervention group, and 65 participants were in the control group. PERANTARA reduced the time to definitive diagnosis by 13.3 days (M [SD]: 25.90 [23.20] in the intervention group vs 39.29 [35.10] in the control group; mean difference = -13.26, 95% CI = -24.51 to -2.00, P = .02). No significant difference was found between the groups in BC knowledge, symptoms of anxiety, depression, quality of life, or health status.
CONCLUSIONS


PERANTARA reduced the time to definitive diagnosis among Indonesian women with BC symptoms. Psychoeducation may be an important addition to regular BC care to prevent undue delays in diagnostic procedures.",2020,"No significant difference was found between the groups in BC knowledge, symptoms of anxiety, depression, quality of life, or health status.
","['132 women with BC symptoms from four hospitals; 67 participants were in the intervention group, and 65 participants were in the control group', 'women with breast cancer (BC) symptoms', 'Indonesian women with BC symptoms', 'Indonesian women with breast cancer symptoms']",[],"['time between the first medical consultation and the definitive diagnosis', 'BC knowledge, symptoms of anxiety, depression, quality of life, or health status', 'BC knowledge, measured by the Breast Cancer Knowledge Test (BCKT); symptoms of anxiety and depression, measured by the Hospital Anxiety and Depression Scale (HADS); quality of life, measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF); and health status, measured by the EQ-5D-5L', 'time to definitive diagnosis']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0337900', 'cui_str': 'Indonesians (ethnic group)'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034380'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}]",132.0,0.100029,"No significant difference was found between the groups in BC knowledge, symptoms of anxiety, depression, quality of life, or health status.
","[{'ForeName': 'Hari', 'Initials': 'H', 'LastName': 'Setyowibowo', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Joke A M', 'Initials': 'JAM', 'LastName': 'Hunfeld', 'Affiliation': 'Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Aulia', 'Initials': 'A', 'LastName': 'Iskandarsyah', 'Affiliation': 'Department of Clinical Psychology, Faculty of Psychology, Universitas Padjadjaran, Jatinangor, Indonesia.'}, {'ForeName': 'Whisnu', 'Initials': 'W', 'LastName': 'Yudiana', 'Affiliation': 'Department of Experimental Psychology, Faculty of Psychology, Universitas Padjadjaran, Jatinangor, Indonesia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Passchier', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Sawitri S', 'Initials': 'SS', 'LastName': 'Sadarjoen', 'Affiliation': 'Department of Clinical Psychology, Faculty of Psychology, Universitas Padjadjaran, Jatinangor, Indonesia.'}, {'ForeName': 'Dharmayanti F', 'Initials': 'DF', 'LastName': 'Badudu', 'Affiliation': 'Department of Surgical Oncology, Hasan Sadikin Hospital, Bandung, Indonesia.'}, {'ForeName': 'Drajat R', 'Initials': 'DR', 'LastName': 'Suardi', 'Affiliation': 'Department of Surgical Oncology, Hasan Sadikin Hospital, Bandung, Indonesia.'}, {'ForeName': ""Edith Van't"", 'Initials': 'EV', 'LastName': 'Hof', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Sijbrandij', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]",Psycho-oncology,['10.1002/pon.5316']
889,31801940,Ofatumumab maintenance prolongs progression-free survival in relapsed chronic lymphocytic leukemia: final analysis of the PROLONG study.,"We report the final analysis of the PROLONG study on ofatumumab maintenance in relapsed chronic lymphocytic leukemia (CLL). In all, 480 patients with CLL in complete or partial remission after second- or third-line treatment were randomized 1:1 to ofatumumab (300 mg first week, followed by 1000 mg every 8 weeks for up to 2 years) or observation. Median follow-up duration was 40.9 months. Median progression-free survival was 34.2 and 16.9 months for ofatumumab and observation arms, respectively, (hazard ratio, 0.55 [95% confidence interval, 0.43-0.70]; P < 0.0001). Median time to next treatment for ofatumumab and observation arms, respectively, was 37.4 and 27.6 months (0.72 [0.57-0.91]; P = 0.0044). Overall survival was similar in both arms; median was not reached (0.99 [0.72-1.37]). Grade ≥ 3 adverse events occurred in 62% and 51% of patients in ofatumumab and observation arms, respectively, the most common being neutropenia (23% and 10%), pneumonia (13% and 12%) and febrile neutropenia (6% and 4%). Up to 60 days after the last treatment, four deaths were reported in the ofatumumab arm versus six in the observation arm, none considered related to ofatumumab. Ofatumumab maintenance significantly prolonged progression-free survival in patients with relapsed CLL and was well tolerated.",2019,Overall survival was similar in both arms; median was not reached (0.99 [0.72-1.37]).,"['relapsed chronic lymphocytic leukemia (CLL', 'relapsed chronic lymphocytic leukemia', '480 patients with CLL in complete or partial remission after second- or third-line treatment']",['Ofatumumab maintenance'],"['Median progression-free survival', 'tolerated', 'Grade\u2009≥', 'progression-free survival', 'Median time', 'neutropenia', 'pneumonia', 'febrile neutropenia', 'Overall survival', '3 adverse events']","[{'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C2986605', 'cui_str': 'Third line treatment'}]","[{'cui': 'C1832027', 'cui_str': 'ofatumumab'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",480.0,0.0753233,Overall survival was similar in both arms; median was not reached (0.99 [0.72-1.37]).,"[{'ForeName': 'Marinus', 'Initials': 'M', 'LastName': 'van Oers', 'Affiliation': 'Academisch Medisch Centrum and HOVON, Amsterdam, The Netherlands. m.h.vanoers@amc.uva.nl.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Smolej', 'Affiliation': 'University Hospital and Faculty of Medicine, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Petrini', 'Affiliation': 'Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Offner', 'Affiliation': 'Universitair Ziekenhuis Gent, Gent, Belgium.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Grosicki', 'Affiliation': 'Department of Hematology and Cancer Prevention, Silesian Medical University, Katowice, Poland.'}, {'ForeName': 'Mark-David', 'Initials': 'MD', 'LastName': 'Levin', 'Affiliation': 'Albert Schweitzer Ziekenhuis Dordrecht and HOVON, Dordrecht, The Netherlands.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Novartis Oncology, East Hanover, NJ, USA.'}, {'ForeName': 'Hiya', 'Initials': 'H', 'LastName': 'Banerjee', 'Affiliation': 'Novartis Oncology, East Hanover, NJ, USA.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Stefanelli', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Hoever', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Geisler', 'Affiliation': 'Rigshospitalet-Koebenhavn, Copenhagen, Denmark.'}]",Blood cancer journal,['10.1038/s41408-019-0260-2']
890,31348731,Immunogenicity and safety of a meningococcal serogroups A and C tetanus toxoid conjugate vaccine (MenAC-TT): two immune schedules in toddles aged 12-23 months in China.,"Background : This exploratory study aimed to assess the immunogenicity and safety of 1 and 2 doses of meningococcal serogroups A and C tetanus toxoid-conjugate vaccine (MenAC-TT) in toddles. Methods : Healthy participants aged 12-23 months were randomized into two groups to receive 1 or 2 doses of the tested vaccine. The interval was 28 days between two doses. Blood samples were collected at day 0 before the immunization and day 28 post-each dose. Safety observation was conducted during 28 days after each vaccination. Serious adverse event (SAE) was conducted throughout 6 month observation period. Results : Overall 301 toddles were vaccinated. Twenty-eight days post full-course vaccination, ≥97.20% toddles had titers ≥1:8 and ≥81.48% had titers ≥1:128 for MenA and MenC in the two schedules groups. There were no significant differences between the two schedule groups for each titer thresholds and serogroups. Up to month 12 post the first dose, titers ≥1:8 and 1:128 were declined to 71.32-80.83% and 26.67-57.85% for each meningococcal serogroups. Most adverse reactions (ARs) were mild or moderate, and the incidence of grade 3 ARs was below 3.33%. The incidence of redness was significantly higher in the two doses group than that in the one dose group, in terms of grade 1 and grade 2 were higher. No SAEs were considered causally related to vaccination. Conclusion : The MenAC-TT showed similarly safety and immunogenicity profile in toddles with two schedules. It will be more important to provide the data for formulating appropriate immunization strategies in different age groups in China.",2019,"The incidence of redness was significantly higher in the two doses group than that in the one dose group, in terms of grade 1 and grade 2 were higher.","['Healthy participants aged 12-23\xa0months', 'toddles aged 12-23 months in China', 'different age groups in China']","[' ', 'meningococcal serogroups A and C tetanus toxoid-conjugate vaccine (MenAC-TT', 'meningococcal serogroups A and C tetanus toxoid conjugate vaccine (MenAC-TT']","['Blood samples', 'Immunogenicity and safety', 'Serious adverse event (SAE', 'safety and immunogenicity profile', 'immunogenicity and safety', 'incidence of redness']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}]","[{'cui': 'C0449543', 'cui_str': 'Serogroup'}, {'cui': 'C0305062', 'cui_str': 'Clostridium tetani toxoid antigen, inactivated'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}]",28.0,0.132365,"The incidence of redness was significantly higher in the two doses group than that in the one dose group, in terms of grade 1 and grade 2 were higher.","[{'ForeName': 'Jialei', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Jiangsu Provincial Center for Diseases Control and Prevention, Nanjing, China.'}, {'ForeName': 'Hongguang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Public Health, Southeast University, Nanjing, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Chu', 'Affiliation': 'Jiangsu Provincial Center for Diseases Control and Prevention, Nanjing, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Liang', 'Affiliation': 'Jiangsu Provincial Center for Diseases Control and Prevention, Nanjing, China.'}, {'ForeName': 'Jingxin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Jiangsu Provincial Center for Diseases Control and Prevention, Nanjing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': 'OLYMVAX biopharmaceutical Co., LTD., Chengdu, China.'}, {'ForeName': 'Yuemei', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Jiangsu Provincial Center for Diseases Control and Prevention, Nanjing, China.'}, {'ForeName': 'Fanyue', 'Initials': 'F', 'LastName': 'Meng', 'Affiliation': 'Jiangsu Provincial Center for Diseases Control and Prevention, Nanjing, China.'}, {'ForeName': 'Fengcai', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'Jiangsu Provincial Center for Diseases Control and Prevention, Nanjing, China.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1627816']
891,31814316,Effects of walking on sundown syndrome in community-dwelling people with Alzheimer's disease.,"BACKGROUND


Sundown syndrome is an important care issue for people with dementia (PwD) and for family caregivers. Walking is a safe and simple physical activity for most PwD, yet no research has explored the effects of different long-term walking periods on sundown syndrome.
OBJECTIVES


This study aimed to determine the effects of walking on sundown syndrome, and to identify whether different walking time periods would show different effects on sundown syndrome in community-dwelling people with Alzheimer's disease.
METHODS


A quasi-experimental designed study with repeated measurements was conducted. Sixty PwD were recruited and assigned to either the control group or the morning or afternoon walking group according to their caregiver's preference. The participants in the two walking groups completed an average of 120-min walking per week, accompanied by their caregivers. Forty-six achieved the 6-month intervention. Four measurements were taken, one at the pretest and one at weeks 8, 16 and 24. The Chinese version of the Cohen-Mansfield Agitation Inventory, community form (C-CMAI) was used to assess the severity of the sundown syndrome. The generalised estimating equation (GEE) was applied for the longitudinal data analysis.
RESULTS


There was a significant change across the study period (p = .048) in the morning walking group, indicating that the score for sundown syndrome decreased when PwD walked in the morning. Considering group effects, compared to the control group, the C-CMAI scores significantly decreased after 16 weeks of walking in the afternoon walking group (p = .001) and after 24 weeks in both the morning and afternoon walking groups (p = .001), indicating that after PwD had walked for 16 weeks, sundown syndrome ameliorated in the afternoon group and continually decreased after 24 weeks in both the morning and afternoon groups. However, there was no significant group difference between the morning and afternoon walking groups during the 24-week walking intervention.
CONCLUSIONS


The results indicated that both morning walking and afternoon walking are beneficial for ameliorating the symptoms of sundown syndrome; however, walking in the afternoon may have a faster effect on the symptoms than walking in the morning. Walking is a safe, simple, feasible and effective intervention to benefit individuals with sundown syndrome.
IMPLICATIONS FOR PRACTICE


Regularly walking for 30 min a day, four times a week, is beneficial to alleviate sundown syndrome among PwD living in the community. Either morning or afternoon walking is effective for decreasing sundown syndrome, and the longer the walking time, the greater the impact on sundown syndrome.",2020,"Considering group effects, compared to the control group, the C-CMAI scores significantly decreased after 16 weeks of walking in the afternoon walking group (p = .001) and after 24 weeks in both the morning and afternoon walking groups (p = .001), indicating that after PwD had walked for 16 weeks, sundown syndrome ameliorated in the afternoon group and continually decreased after 24 weeks in both the morning and afternoon groups.","[""community-dwelling people with Alzheimer's disease"", 'Sixty PwD', 'people with dementia (PwD) and for family caregivers']","[""control group or the morning or afternoon walking group according to their caregiver's preference"", 'afternoon walking']","['sundown syndrome', 'C-CMAI scores']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0439550', 'cui_str': 'Afternoon (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}]","[{'cui': 'C1142436', 'cui_str': 'Sundowning (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0219769,"Considering group effects, compared to the control group, the C-CMAI scores significantly decreased after 16 weeks of walking in the afternoon walking group (p = .001) and after 24 weeks in both the morning and afternoon walking groups (p = .001), indicating that after PwD had walked for 16 weeks, sundown syndrome ameliorated in the afternoon group and continually decreased after 24 weeks in both the morning and afternoon groups.","[{'ForeName': 'Yen-Hua', 'Initials': 'YH', 'LastName': 'Shih', 'Affiliation': 'Department of Nursing, MeiHo University, Pingtung, Taiwan ROC.'}, {'ForeName': 'Ming-Chyi', 'Initials': 'MC', 'LastName': 'Pai', 'Affiliation': 'Division of Behavioral Neurology, Department of Neurology, College of Medicine, National Cheng Kung University, Tainan, Taiwan ROC.'}, {'ForeName': 'Huey-Shyan', 'Initials': 'HS', 'LastName': 'Lin', 'Affiliation': 'Department of Health-Business Administration, Fooyin University, Kaohsiung, Taiwan ROC.'}, {'ForeName': 'Pi-Shan', 'Initials': 'PS', 'LastName': 'Sung', 'Affiliation': 'Department of Neurology, College of Medicine, National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan ROC.'}, {'ForeName': 'Jing-Jy', 'Initials': 'JJ', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, National Cheng Kung University, Tainan, Taiwan ROC.'}]",International journal of older people nursing,['10.1111/opn.12292']
892,31676585,A Magic Therapy Program to Alleviate Anxiety in Pediatric Inpatients.,"OBJECTIVES


Hospitalization generates increased psychological discomfort for children and their caregivers. This anxiety can affect the patient-caretaker response to the health care team and the course of treatment. We aim to evaluate the impacts of a magic therapy program, organized and facilitated by medical students, on alleviating pediatric inpatient and caregiver anxiety.
METHODS


Patients aged 5 to 16 years admitted to an inpatient pediatric unit and their caregivers were eligible for inclusion. Patient-caregiver pairs were randomly assigned to a magic therapy intervention group or a control group. Anxiety was measured before and after the intervention by using validated self-report tools. The Facial Image Scale and Venham Picture Test were used to measure anxiety for young patients, the short State-Trait Anxiety Inventory and Facial Image Scale were used for older patients, and the short State-Trait Inventory was used for caregivers. A subset of the intervention group was reevaluated at 1 hour posttherapy. Health professionals were also surveyed regarding their opinions of the program.
RESULTS


One hundred patients and 90 caregivers were enrolled. The patient magic group's standardized anxiety was reduced by 25% ( n  = 47;  P  < .001) posttherapy. The caregiver magic group's anxiety was reduced by 24% ( n  = 34;  P  < .001). Data suggest that anxiety reductions lasted through at least 1 hour posttherapy. Physicians ( n  = 9), nurses ( n  = 8), and pediatric residents ( n  = 20) supported program continuance, reported favorable impressions, and suggested patient, caregiver, and staff benefits.
CONCLUSIONS


Integration of a magic therapy program into pediatric inpatient care was feasible and successful in decreasing patient and caretaker anxiety. Health care professionals support the program's continuance.",2019,The caregiver magic group's anxiety was reduced by 24% ( n  = 34;  P  < .001).,"['Patient-caregiver pairs', 'Patients aged 5 to 16 years admitted to an inpatient pediatric unit and their caregivers were eligible for inclusion', 'children and their caregivers', 'One hundred patients and 90 caregivers were enrolled', 'Pediatric Inpatients']","['magic therapy intervention group or a control group', 'Magic Therapy Program']","[""caregiver magic group's anxiety"", 'short State-Trait Anxiety Inventory and Facial Image Scale', 'Anxiety', 'psychological discomfort', 'standardized anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0024460', 'cui_str': 'Magic'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0024460', 'cui_str': 'Magic'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0222045'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}]",100.0,0.0248254,The caregiver magic group's anxiety was reduced by 24% ( n  = 34;  P  < .001).,"[{'ForeName': 'Harrison D', 'Initials': 'HD', 'LastName': 'Pravder', 'Affiliation': 'Department of Pediatrics, Renaissance School of Medicine, Stony Brook University, Stony Brook, New York; and harrison@magic-aid.org.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Leng-Smith', 'Affiliation': 'Department of Pediatrics, Renaissance School of Medicine, Stony Brook University, Stony Brook, New York; and.'}, {'ForeName': 'Andrew I', 'Initials': 'AI', 'LastName': 'Brash', 'Affiliation': 'Department of Pediatrics, Renaissance School of Medicine, Stony Brook University, Stony Brook, New York; and.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Elkin', 'Affiliation': 'Department of Pediatrics, Renaissance School of Medicine, Stony Brook University, Stony Brook, New York; and.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Attard', 'Affiliation': 'Child Life Program and.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Rose', 'Affiliation': 'Child Life Program and.'}, {'ForeName': 'Catherine R', 'Initials': 'CR', 'LastName': 'Messina', 'Affiliation': 'Department of Family, Population, and Preventive Medicine and.'}, {'ForeName': 'Maribeth B', 'Initials': 'MB', 'LastName': 'Chitkara', 'Affiliation': 'Department of Pediatrics, Renaissance School of Medicine, Stony Brook University, Stony Brook, New York; and.'}]",Hospital pediatrics,['10.1542/hpeds.2019-0212']
893,31899739,"Did Osteoblastic Cell Therapy Improve the Prognosis of Pre-fracture Osteonecrosis of the Femoral Head? A Randomized, Controlled Trial.","BACKGROUND


In patients with nontraumatic osteonecrosis of the femoral head (ONFH), implantation of bone marrow aspirate concentrate (BMAC) could delay the progression of osteonecrosis and improve symptoms in pre-fracture ONFH. However, the BMAC content, especially in osteoblastic stem cells, could have an important individual variability. An autologous osteoblastic cell product could improve the effect of such cell-based therapy.
QUESTIONS/PURPOSES


(1) Does autologous osteoblastic cell therapy decrease the likelihood of progression to subchondral fracture with or without early collapse corresponding to Association Research Circulation Osseous (ARCO) classification Stage III or higher, and provide a clinically important pain improvement compared with BMAC treatment alone? (2) Were patients treated with osteoblastic cell therapy less likely to undergo subsequent THA? (3) What proportion of patients in the treatment and control groups experienced adverse events after surgery?
METHODS


Between 2004 and 2011, we treated 279 patients for Stage I to II hip osteonecrosis (ON) with surgery. During that time, our general indications for surgery in this setting included non-fracture ON lesions. To be eligible for this randomized, single-blind trial, patients needed to have an ONFH Stage I or II; we excluded those with traumatic ONFH, hemoglobinopathies and positive serology for hepatitis B, C or HIV. Of those treated surgically for this diagnosis during the study period, 24% (67) agreed to participate in this randomized trial. Hips with pre-fracture ONFH were randomly treated with a core decompression procedure associated with either implantation of a BMAC (BMAC group; n = 26) or osteoblastic cell (osteoblastic cell group; n = 30). The groups were not different in terms of clinical and imaging characteristics. The primary study outcome was treatment response, defined as the absence of progression to subchondral fracture stage (ARCO stage III or higher) plus a clinically important pain improvement defined as 1 cm on a 10-cm VAS. The secondary endpoint of interest was the frequency in each group of subsequent THA and the frequency of adverse events. The follow-up duration was 36 months. We used an as-treated analysis (rather than intention-to-treat) for our efficacy endpoint, and an intention-to-treat analysis for adverse events. Overall, 26 of 26 patients in the BMAC group and 27 of 30 in the osteoblastic cell group completed the trial.
RESULTS


At 36 months, no clinically important differences were found in any study endpoint. There was no difference in the proportion of patients who had progressed to fracture (ARCO stage III or higher; 46% of the BMAC hips [12 of 26] versus 22% in the hips with osteoblastic cells [six of 27], hazard ratio, 0.47 [95% CI 0.17 to 1.31]; p = 0.15). There was no clinically important difference in VAS pain scores. No differences were found for either the WOMAC or the Lequesne indexes. With the numbers available, there was no difference in the proportion of patients in the groups who underwent THA at 36 months 15% (four of 27) with osteoblastic cells versus 35% (nine of 26) with BMAC; p = 0.09 With the numbers available, we found no differences between the treatment and control groups in terms of the frequencies of major adverse events.
CONCLUSIONS


We found no benefit to osteoblastic cells over BMAC in patients with pre-collapse ONFH; side effects were uncommon and generally mild in both groups. This study could be used as pilot data to help determine sample sizes for larger (presumably multicenter) randomized controlled trials. However, this novel treatment cannot be recommended in routine practice until future, larger studies demonstrate efficacy.
LEVEL OF EVIDENCE


Level II, therapeutic study.",2020,No differences were found for either the WOMAC or the Lequesne indexes.,"['patients needed to have an ONFH Stage I or II; we excluded those with traumatic ONFH, hemoglobinopathies and positive serology for hepatitis B, C or HIV', '26 patients in the BMAC group and 27 of 30 in the osteoblastic cell group completed the trial', 'Hips with pre-fracture ONFH', 'patients with nontraumatic osteonecrosis of the femoral head (ONFH), implantation of', 'Between 2004 and 2011', '279 patients for Stage I to II hip osteonecrosis (ON) with surgery']","['autologous osteoblastic cell therapy', 'bone marrow aspirate concentrate (BMAC', 'core decompression procedure associated with either implantation of a BMAC (BMAC group; n = 26) or osteoblastic cell (osteoblastic cell', 'Osteoblastic Cell Therapy', 'osteoblastic cell therapy']","['absence of progression to subchondral fracture stage (ARCO stage III or higher) plus a clinically important pain improvement defined as 1 cm on a 10-cm VAS', 'subsequent THA and the frequency of adverse events', 'adverse events', 'VAS pain scores']","[{'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0019045', 'cui_str': 'Hemoglobinopathies'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0036745', 'cui_str': 'Serology'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0029445', 'cui_str': 'Osteonecrosis'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0302189', 'cui_str': 'Cell Therapy'}, {'cui': 'C0857285', 'cui_str': 'Marrow aspirate'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}]","[{'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C2743413', 'cui_str': 'ARCO'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",,0.116832,No differences were found for either the WOMAC or the Lequesne indexes.,"[{'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Hauzeur', 'Affiliation': 'J.-P. Hauzeur, Rheumatology and Physical Medicine Department, Hospital Erasme, Université Libre de Bruxelles, Brussels, Belgium C. Lechanteur, Y. Beguin, E. Baudoux, Haematology & Laboratory of Cell Therapy, CHU de Liège, Université de Liège, Liège, Belgium V. De Maertelaer, SBIM & IRIBHM, Faculty of Medicine, Université Libre de Bruxelles, Brussels, Belgium S. Pather, R. Katz, Radiology Department, Hospital Erasme, Université Libre de Bruxelles, Brussels, Belgium. M. Malaise, J.-P. Hauzeur, Department of Rheumatology, CHU de Liège, Université de Liège, Liège, Belgium J. Ino, Bone Therapeutics S.A., Gosselies, Belgium.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Lechanteur', 'Affiliation': ''}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Baudoux', 'Affiliation': ''}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'De Maertelaer', 'Affiliation': ''}, {'ForeName': 'Sanjiva', 'Initials': 'S', 'LastName': 'Pather', 'Affiliation': ''}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Katz', 'Affiliation': ''}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Malaise', 'Affiliation': ''}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Ino', 'Affiliation': ''}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Beguin', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001107']
894,31898776,Pressure support ventilation-pro decreases propofol consumption and improves postoperative oxygenation index compared with pressure-controlled ventilation in children undergoing ambulatory surgery: a randomized controlled trial.,"PURPOSE


The PSVPro mode is increasingly being used for surgeries under laryngeal mask airway owing to improved ventilator-patient synchrony and decreased work of breathing. We hypothesized that PSVPro ventilation mode would reduce consumption of anesthetic agents compared with pressure control ventilation (PCV).
METHODS


Seventy children between three and eight years of age undergoing elective lower abdominal and urological surgery were randomized into PCV group (n = 35) or PSVPro group (n = 35). General anesthesia was induced with sevoflurane and a Proseal LMA™ was inserted. Anesthesia was maintained with propofol infusion to maintain the entropy values between 40 and 60. In the PCV mode, the inspiratory pressure was adjusted to obtain an expiratory tidal volume of 8 mL·kg -1  and a respiratory rate of 12-20/min. In the PSVPRO group, the flow trigger was set at 0.4 L·min -1  and pressure support was adjusted to obtain expiratory tidal volume of 8 mL·kg -1 . Consumption of anesthetic agent was recorded as the primary outcome. Emergence time and discharge time were recorded as secondary outcomes.
RESULTS


The PSVPro group showed significant reduction in propofol consumption compared with the PCV group (mean difference, 33.3 µg -1 ·kg -1 ·min -1 ; 95% confidence interval [CI], 24.2 to 42.2). There was decrease in the emergence time in the PSVPro group compared with the PCV group (mean difference, 3.5 min; 95% CI, 2.8 to 4.2) and in time to achieve modified Aldrete score > 9 (mean difference, 3.6 min; 95% CI, 1.9 to 5.2).
CONCLUSION


The PSVPro mode decreases propofol consumption and emergence time, and improves oxygenation index in children undergoing ambulatory surgery.
TRIAL REGISTRATION


Clinical Trial Registry of India (CTRI/2017/12/010942); registered 21 December, 2017.",2020,"The PSVPro group showed significant reduction in propofol consumption compared with the PCV group (mean difference, 33.3 µg -1 ·kg -1 ·min -1 ; 95% confidence interval [CI], 24.2 to 42.2).","['children undergoing ambulatory surgery', 'Seventy children between three and eight years of age undergoing elective lower abdominal and urological surgery']","['pressure-controlled ventilation', 'propofol', 'PCV', 'Pressure support ventilation-pro decreases propofol consumption', 'PSVPro ventilation', 'sevoflurane', 'PSVPro']","['emergence time', 'Emergence time and discharge time', 'oxygenation index', 'postoperative oxygenation index', 'inspiratory pressure', 'propofol consumption and emergence time', 'propofol consumption']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory Surgery'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0564626', 'cui_str': 'Pressure controlled ventilation (procedure)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0018935', 'cui_str': 'Erythrocyte Volume, Packed'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",70.0,0.136987,"The PSVPro group showed significant reduction in propofol consumption compared with the PCV group (mean difference, 33.3 µg -1 ·kg -1 ·min -1 ; 95% confidence interval [CI], 24.2 to 42.2).","[{'ForeName': 'Swapnabharati', 'Initials': 'S', 'LastName': 'Moharana', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Sector-12, Chandigarh, 160012, India.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Jain', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Sector-12, Chandigarh, 160012, India. jaindivya77@rediffmail.com.'}, {'ForeName': 'Neerja', 'Initials': 'N', 'LastName': 'Bhardwaj', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Sector-12, Chandigarh, 160012, India.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Gandhi', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Sector-12, Chandigarh, 160012, India.'}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Yaddanapudi', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Sector-12, Chandigarh, 160012, India.'}, {'ForeName': 'Badal', 'Initials': 'B', 'LastName': 'Parikh', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Sector-12, Chandigarh, 160012, India.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-019-01556-9']
895,31899602,Ubrogepant Is Not Associated With Clinically Meaningful Elevations of Alanine Aminotransferase in Healthy Adult Males.,"Ubrogepant is a novel, oral calcitonin gene-related peptide (CGRP) receptor antagonist intended for the acute treatment of migraine attacks. Ubrogepant has a chemical structure distinct from previous small-molecule CGRP receptor antagonists that were associated with elevated serum alanine aminotransferase (ALT) in clinical trials. Here, we report overall and hepatic safety data from two placebo-controlled phase I trials of ubrogepant, spray-dried oral compressed tablet (SD-OCT) in healthy male volunteers. Trial A was a pharmacokinetic (PK) trial of single (100-400 mg) and multiple (40-400 mg) ascending doses. Trial B was a dedicated hepatic safety trial assessing daily use of ubrogepant 150 mg for 28 days. Serum ALT (as hepatotoxicity biomarker) and PK data are reported. Ubrogepant was well-tolerated in both trials, with a low incidence of adverse events that did not differ greatly from placebo. Changes in mean ALT levels were minimal and similar to placebo. Over 28 days of treatment, the mean percentage change in ALT from baseline was < 5% at all time points. No participant in either trial demonstrated ALT ≥ 3× upper limit of normal at any time. Ubrogepant SD-OCT demonstrated linear PK appropriate for acute treatment of migraine, with rapid uptake (time of maximum plasma concentration (t max  ): 2-3 hours) and no accumulation with daily use. Overall, there was no evidence of ubrogepant-associated hepatotoxicity with daily doses up to 400 mg for 10 days or with daily ubrogepant 150 mg for 28 days. Supratherapeutic dosing is a useful strategy for characterizing hepatic safety in early drug development.",2020,No participant in either trial demonstrated ALT ≥ ,"['Healthy Adult Males', 'healthy male volunteers']","['placebo', 'ubrogepant, spray-dried oral compressed tablet (SD-OCT', 'Supratherapeutic']","['adverse events', 'mean ALT levels', 'Serum ALT']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4505936', 'cui_str': 'ubrogepant'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0332260', 'cui_str': 'Compressing (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.337401,No participant in either trial demonstrated ALT ≥ ,"[{'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Ankrom', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Phung', 'Initials': 'P', 'LastName': 'Bondiskey', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Chi-Chung', 'Initials': 'CC', 'LastName': 'Li', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Palcza', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Marissa F', 'Initials': 'MF', 'LastName': 'Dockendorf', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Matthews', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Panebianco', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Reynders', 'Affiliation': 'MSD, Brussels, Belgium.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Wagner', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Abhijeet', 'Initials': 'A', 'LastName': 'Jakate', 'Affiliation': 'Allergan plc, Madison, New Jersey, USA.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Mesens', 'Affiliation': 'SGS Life Science Services, Antwerp, Belgium.'}, {'ForeName': 'Walter K', 'Initials': 'WK', 'LastName': 'Kraft', 'Affiliation': 'Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Eugene E', 'Initials': 'EE', 'LastName': 'Marcantonio', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.'}]",Clinical and translational science,['10.1111/cts.12728']
896,31899035,Incidence of Macular Atrophy after Untreated Neovascular Age-Related Macular Degeneration: Age-Related Eye Disease Study Report 40.,"PURPOSE


To report the natural history of untreated neovascular age-related macular degeneration (nAMD) regarding subsequent macular atrophy.
DESIGN


Prospective cohort within a randomized, controlled trial of oral micronutrient supplements.
PARTICIPANTS


Age-Related Eye Disease Study (AREDS) participants (55-80 years) who demonstrated nAMD during follow-up (1992-2005), prior to anti-vascular endothelial growth factor (VEGF) therapy.
METHODS


Color fundus photographs were collected at annual study visits and graded centrally for late age-related macular degeneration (AMD). Incident macular atrophy after nAMD was examined by Kaplan-Meier analysis and proportional hazards regression.
MAIN OUTCOME MEASURES


Incident macular atrophy after nAMD.
RESULTS


Of the 4757 AREDS participants, 708 eyes (627 participants) demonstrated nAMD during follow-up and were eligible. The cumulative risks of incident macular atrophy after untreated nAMD were 9.6% (standard error, 1.2%), 31.4% (standard error, 2.2%), 43.1% (standard error, 2.6%), and 61.5% (standard error, 4.3%) at 2, 5, 7, and 10 years, respectively. This corresponded to a linear risk of 6.5% per year. The cumulative risk of central involvement was 30.4% (standard error, 3.2%), 43.4% (standard error, 3.8%), and 57.0% (standard error, 4.8%) at first appearance of atrophy, 2 years, and 5 years, respectively. Geographic atrophy (GA) in the fellow eye was associated with increased risk of macular atrophy (hazard ratio [HR], 1.70; 95% confidence interval [CI], 1.17-2.49; P = 0.006). However, higher 52-single nucleotide polymorphism AMD genetic risk score was not associated with increased risk of macular atrophy (HR, 1.03; 95% CI, 0.90-1.17; P = 0.67). Similarly, no significant differences were observed according to SNPs at CFH, ARMS2, or C3.
CONCLUSIONS


The rate of incident macular atrophy after untreated nAMD is relatively high, increasing linearly over time and affecting half of eyes by 8 years. Hence, factors other than anti-VEGF therapy are involved in atrophy development, including natural progression to GA. Comparison with studies of treated nAMD suggests it may not be necessary to invoke a large effect of anti-VEGF therapy on inciting macular atrophy, although a contribution remains possible. Central involvement is present in one third of eyes at the outset (similar to pure GA) and increases linearly to half at 3 years.",2019,"Geographic atrophy (GA) in the fellow eye was associated with increased risk of macular atrophy (hazard ratio [HR], 1.70; 95% confidence interval [CI], 1.17-2.49; P = 0.006).","['Of the 4757 AREDS participants, 708 eyes (627 participants) demonstrated nAMD during follow-up and were eligible', 'Macular Atrophy after Untreated Neovascular Age-Related Macular Degeneration', 'Color fundus photographs were collected at annual study visits and graded centrally for late age-related macular degeneration (AMD', 'Age-Related Eye Disease Study (AREDS) participants (55-80 years) who demonstrated nAMD during follow-up (1992-2005), prior to anti-vascular endothelial growth factor (VEGF) therapy']",['oral micronutrient supplements'],"['risk of macular atrophy', 'cumulative risk of central involvement', 'higher 52-single nucleotide polymorphism AMD genetic risk score', 'cumulative risks of incident macular atrophy', 'SNPs at CFH, ARMS2, or C3', 'rate of incident macular atrophy', 'Geographic atrophy (GA']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1288283', 'cui_str': 'Anetoderma'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0227817', 'cui_str': 'Uterine Fundus'}, {'cui': 'C0441468', 'cui_str': 'Photograph (physical object)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0242383', 'cui_str': 'Maculopathy, Age-Related'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0015397', 'cui_str': 'Eye Diseases'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1288283', 'cui_str': 'Anetoderma'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}]",627.0,0.0872275,"Geographic atrophy (GA) in the fellow eye was associated with increased risk of macular atrophy (hazard ratio [HR], 1.70; 95% confidence interval [CI], 1.17-2.49; P = 0.006).","[{'ForeName': 'Panos G', 'Initials': 'PG', 'LastName': 'Christakis', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Agrón', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Klein', 'Affiliation': 'Casey Eye Institute, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Traci E', 'Initials': 'TE', 'LastName': 'Clemons', 'Affiliation': 'Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'J Peter', 'Initials': 'JP', 'LastName': 'Campbell', 'Affiliation': 'Casey Eye Institute, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Frederick L', 'Initials': 'FL', 'LastName': 'Ferris', 'Affiliation': 'Ophthalmic Research Consultants, LLC, Waxhaw, North Carolina.'}, {'ForeName': 'Emily Y', 'Initials': 'EY', 'LastName': 'Chew', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Tiarnan D', 'Initials': 'TD', 'LastName': 'Keenan', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland. Electronic address: tiarnan.keenan@nih.gov.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2019.11.016']
897,31762222,Comparison of the Effects of Proximal Humeral Internal Locking System (PHILOS) Alone and PHILOS Combined with Fibular Allograft in the Treatment of Neer Three- or Four-part Proximal Humerus Fractures in the Elderly.,"OBJECTIVE


To compare and analyze the clinical outcomes of the proximal humeral internal locking system (PHILOS) alone and the PHILOS combined with fibular allograft in the treatment of Neer three- and four-part proximal humerus fractures (PHF) in the elderly.
METHODS


From January 2014 to January 2018, a total of 42 elderly patients with Neer three- or four-part PHF admitted to our hospital were randomly divided into observation group and control group, with 21 patients in each group. The observation group was treated with the PHILOS combined with fibular allograft. The control group was treated with the PHILOS alone. Perioperative parameters and fracture classification were recorded in the two groups. Function results were assessed by Visual Analog Scale (VAS), Constant-Murley score (CMS), American Shoulder and Elbow Surgeons (ASES) score, and the Disability of Arm-Shoulder-Hand (DASH) score. Radiological results were evaluated using the neck-shaft angle (NSA) and humeral head height (HHH), and complications were also recorded in each group.
RESULTS


There were no significant differences between the two groups in terms of preoperative status, age, gender, cause of trauma, fracture site, and fracture classification. The average follow-up time was 12 months. At the last follow-up, the VAS and DASH observation groups were lower than the control group, and there was significant difference between the two groups (P < 0.05). The CMS and ASES were higher in the observation group than the control group, and there was significant difference between the two groups (P < 0.05). The mean difference in the NSA and HHH were lower in the observation group than the control group, and there was a significant difference between the two groups (P < 0.05). There was one postoperative complication in the observation group, which was humeral head avascular necrosis (AVN). There were seven postoperative complications in the control group, including three cases of humeral head collapse and three cases of screw cutout and one case of humeral head AVN. The incidence of postoperative complications in the observation group was significantly lower than the control group (P < 0.05), there was a significant difference between the two groups.
CONCLUSIONS


For Neer three- or four-part PHF in the elderly patients, PHILOS fixation with fibular allograft shows satisfactory short-term results with respect to humeral head support and maintenance of reduction, and may reduce the incidence of complications associated with fixation using a PHILOS alone.",2019,"The incidence of postoperative complications in the observation group was significantly lower than the control group (P < 0.05), there was a significant difference between the two groups.
","['Neer Three- or Four-part Proximal Humerus Fractures in the Elderly', 'From January 2014 to January 2018, a total of 42 elderly patients with Neer three- or four-part PHF admitted to our hospital', 'Neer three- and four-part proximal humerus fractures (PHF) in the elderly']","['Alone and PHILOS Combined with Fibular Allograft', 'Proximal Humeral Internal Locking System (PHILOS', 'PHILOS combined with fibular allograft', 'proximal humeral internal locking system (PHILOS) alone and the PHILOS combined with fibular allograft']","['neck-shaft angle (NSA) and humeral head height (HHH), and complications', 'NSA and HHH', 'postoperative complications', 'postoperative complication', 'humeral head avascular necrosis (AVN', 'Visual Analog Scale (VAS), Constant-Murley score (CMS), American Shoulder and Elbow Surgeons (ASES) score, and the Disability of Arm-Shoulder-Hand (DASH) score', 'CMS and ASES', 'incidence of postoperative complications', 'Perioperative parameters and fracture classification', 'preoperative status, age, gender, cause of trauma, fracture site, and fracture classification']","[{'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0020162', 'cui_str': 'Humeral Fractures'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0337141', 'cui_str': 'Shaft (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0223683', 'cui_str': 'Humerus Head'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C3887513', 'cui_str': 'Avascular necrosis (morphologic abnormality)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]",42.0,0.0145125,"The incidence of postoperative complications in the observation group was significantly lower than the control group (P < 0.05), there was a significant difference between the two groups.
","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Orthopaedic Surgery, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yi-Min', 'Initials': 'YM', 'LastName': 'Qi', 'Affiliation': 'Department of Orthopaedic Surgery, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopaedic Surgery, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Gang-Rui', 'Initials': 'GR', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedic Surgery, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Sheng-Nai', 'Initials': 'SN', 'LastName': 'Zheng', 'Affiliation': 'Department of Orthopaedic Surgery, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedic Surgery, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Liang', 'Affiliation': 'Department of Orthopaedic Surgery, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Chun-Zhi', 'Initials': 'CZ', 'LastName': 'Jiang', 'Affiliation': 'Department of Orthopaedic Surgery, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}]",Orthopaedic surgery,['10.1111/os.12564']
898,31553438,"Final overall survival results of WJTOG3405, a randomized phase III trial comparing gefitinib versus cisplatin with docetaxel as the first-line treatment for patients with stage IIIB/IV or postoperative recurrent EGFR mutation-positive non-small-cell lung cancer.","BACKGROUND


Primary analysis of the phase III study WJTOG 3405 demonstrated superiority of progression-free survival (PFS) for gefitinib (G) in patients treated with the epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) gefitinib compared with cisplatin plus docetaxel (CD) as the first-line treatment of stage IIIB/IV or postoperative recurrent EGFR mutation-positive non-small-cell lung cancer. This report presents final overall survival (OS) data.
PATIENTS AND METHODS


Patients were randomized between G (250 mg/day orally) and cisplatin (80 mg/m2 intravenously) plus docetaxel (60 mg/m2 i.v.), administered every 21 days for three to six cycles. After the exclusion of 5 patients, 172 patients (86 in each group, modified intention-to-treat population) were included in the survival analysis. OS was re-evaluated using updated data (data cutoff, 30 September 2013; median follow-up time 59.1 months). The Kaplan-Meier method and the log-rank test were used for analysis, and hazard ratios (HRs) for death were calculated using the Cox proportional hazards model.
RESULTS


OS events in the G group and CD group were 68 (79.1%) out of 86 and 59 (68.6%) out of 86, respectively. Median survival time for G and CD were 34.9 and 37.3 months, respectively, with an HR of 1.252 [95% confidence interval (CI): 0.883-1.775, P = 0.2070]. Multivariate analysis identified postoperative recurrence and stage IIIB/IV disease as independent prognostic factors, with an HR of 0.459 (95% CI: 0.312-0.673, P < 0.001). Median survival time (postoperative recurrence versus stage IIIB/IV disease) were 44.5 and 27.5 months in the G group and 45.5 and 32.8 months in the CD group, respectively.
CONCLUSION


G did not show OS benefits over CD as the first-line treatment. OS of patients with postoperative recurrence was better than that of stage IIIB/IV disease, even though both groups had metastatic disease.This study was registered with UMIN (University Hospital Medical Information Network in Japan), number 000000539.",2019,"Median survival time (postoperative recurrence versus stage IIIB/IV disease) were 44.5 and 27.5 months in G group and 45.5 and 32.8 months in CD group, respectively.
","['Patients', 'patients with stage IIIB/IV or postoperative recurrent EGFR mutation-positive non-small cell lung cancer', 'registered with UMIN (University Hospital Medical Information Network in Japan']","['gefitinib (G)in patients treated with the epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) gefitinib compared with cisplatin plus docetaxel (CD', 'cisplatin (80mg/m2 intravenously) plus docetaxel', 'gefitinib versus cisplatin with docetaxel']","['Median survival time for G and CD', 'hazard ratios (HRs) for death', 'postoperative recurrence and stage IIIB/IV disease', 'postoperative recurrence', 'Median survival time (postoperative recurrence versus stage IIIB/IV disease']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0021419', 'cui_str': 'Information Networks'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0034802', 'cui_str': 'c-erbB-1 Protein'}, {'cui': 'C0033681', 'cui_str': 'Tyrosylprotein Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",172.0,0.15013,"Median survival time (postoperative recurrence versus stage IIIB/IV disease) were 44.5 and 27.5 months in G group and 45.5 and 32.8 months in CD group, respectively.
","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yoshioka', 'Affiliation': 'Department of Thoracic Oncology, Kansai Medical University Hospital, Hirakata.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shimokawa', 'Affiliation': 'Department of Cancer Information Research, National Hospital Organization Kyushu Cancer Center, Fukuoka; Department of Biostatistics, Yamaguchi University Graduate School of Medicine, Ube.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Seto', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Yatabe', 'Affiliation': 'Department of Pathology and Molecular Genetics, Aichi Cancer Center Hospital, Nagoya.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Okamoto', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyusyu University, Fukuoka.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tsurutani', 'Affiliation': 'Advanced Cancer Translational Research Institute, Showa University, Tokyo.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Satouchi', 'Affiliation': 'Department of Thoracic Oncology, Hyogo Cancer Center, Akashi.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hirashima', 'Affiliation': 'Department of Thoracic Oncology, Osaka Habikino Medical Center, Habikino.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Atagi', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Kinki-chuo Chest Medical Center, Sakai.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Shibata', 'Affiliation': 'Department of Medical Oncology, Kouseiren Takaoka Hospital, Takaoka.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': 'Department of Respiratory Medicine, Aichi Cancer Center Aichi Hospital, Okazaki.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Toyooka', 'Affiliation': 'Department of General Thoracic Surgery and Breast and Endocrinological Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Internal Medicine III, Wakayama Medical University Hospital, Wakayama.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Kindai University Hospital, Osaka-Sayama.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mitsudomi', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Kindai University Hospital, Osaka-Sayama, Japan. Electronic address: mitsudom@med.kindai.ac.jp.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz399']
899,31007059,A novel muscle cramp scale (MCS) in amyotrophic lateral sclerosis (ALS).,"Objective:  To develop a novel muscle cramp scale (MCS) to assess frequency, severity and clinically meaningful information related to cramps among patients with amyotrophic lateral sclerosis (ALS).  Methods:  This new scale comprises four 5-point subdomains: (1) triggering factors, (2) frequency, (3) location, (4) severity, and (5) the degree to which cramps affect overall daily living. Thirty patients with ALS, who experienced at least 5 cramps per week, participated in a randomized test-retest study. An additional 26 patients participated in a second study assessing cramp changes over 4 weeks using the MCS and a detailed cramp diary.  Results:  To establish internal reliability of the scale, a Cronbach's coefficient value of 0.75 or higher was considered acceptable. Test/retest evaluations comparing in-person and telephone administration were assessed using paired  t -tests and Cohen's kappa statistics. Non-significant differences were identified, and the results revealed moderate to high agreement for each item (range 0.60 to 0.95,  p  < 0.0001). Scale construct validity against the cramp diary was acceptable. There were essentially no significant mean differences in muscle cramps over 4 weeks measured using the MCS and diary, respectively.  Conclusions:  The MCS is a valid, simple, and quick measure for the assessment of muscle cramps in patients with ALS. It can be reliably administered either in person or by telephone and provides richer information than the routinely utilized cramp diary.",2019,"There were essentially no significant mean differences in muscle cramps over 4 weeks measured using the MCS and diary, respectively.  ","['Thirty patients with ALS, who experienced at least 5 cramps per week', 'patients with ALS', '26 patients participated in a second study assessing cramp changes over 4 weeks using the MCS and a detailed cramp diary', 'amyotrophic lateral sclerosis (ALS', 'patients with amyotrophic lateral sclerosis (ALS']",['MCS'],"['muscle cramps', 'degree to which cramps affect overall daily living']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446787', 'cui_str': 'Cramping'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0002736', 'cui_str': 'ALS (Amyotrophic Lateral Sclerosis)'}]",[],"[{'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C1446787', 'cui_str': 'Cramping'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",30.0,0.0232035,"There were essentially no significant mean differences in muscle cramps over 4 weeks measured using the MCS and diary, respectively.  ","[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Mitsumoto', 'Affiliation': 'a Department of Neurology , Eleanor and Lou Gehrig ALS Center, Columbia University Medical Center , New York , NY , USA.'}, {'ForeName': 'Codruta', 'Initials': 'C', 'LastName': 'Chiuzan', 'Affiliation': 'b Department of Biostatistics , Mailman School of Public Health, Columbia University , New York , NY , USA , and.'}, {'ForeName': 'Madison', 'Initials': 'M', 'LastName': 'Gilmore', 'Affiliation': 'a Department of Neurology , Eleanor and Lou Gehrig ALS Center, Columbia University Medical Center , New York , NY , USA.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'b Department of Biostatistics , Mailman School of Public Health, Columbia University , New York , NY , USA , and.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Ibagon', 'Affiliation': 'a Department of Neurology , Eleanor and Lou Gehrig ALS Center, Columbia University Medical Center , New York , NY , USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'McHale', 'Affiliation': 'a Department of Neurology , Eleanor and Lou Gehrig ALS Center, Columbia University Medical Center , New York , NY , USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hupf', 'Affiliation': 'a Department of Neurology , Eleanor and Lou Gehrig ALS Center, Columbia University Medical Center , New York , NY , USA.'}, {'ForeName': 'BjÖrn', 'Initials': 'B', 'LastName': 'Oskarsson', 'Affiliation': 'c Department of Neurology , Mayo Clinic Jacksonville , Jacksonville , FL , USA.'}]",Amyotrophic lateral sclerosis & frontotemporal degeneration,['10.1080/21678421.2019.1603310']
900,31883356,"Rationale and design of the AFFIRM-AHF trial: a randomised, double-blind, placebo-controlled trial comparing the effect of intravenous ferric carboxymaltose on hospitalisations and mortality in iron-deficient patients admitted for acute heart failure.","AIMS


Iron deficiency (ID) is a common co-morbidity in heart failure (HF), associated with impaired functional capacity, poor quality of life and increased morbidity and mortality. Treatment with intravenous (i.v.) ferric carboxymaltose (FCM) has shown improvements in functional capacity, symptoms and quality of life in stable HF patients with reduced ejection fraction. The effect of i.v. iron supplementation on morbidity and mortality in patients hospitalised for acute HF (AHF) and who have ID has yet to be established. The objective of the present article is to present the rationale and design of the AFFIRM-AHF trial (ClinicalTrials.gov NCT02937454) which will investigate the effect of i.v. FCM (vs. placebo) on recurrent HF hospitalisations and cardiovascular (CV) mortality in iron-deficient patients hospitalised for AHF.
METHODS


AFFIRM-AHF is a multicentre, randomised (1:1), double-blind, placebo-controlled trial which recruited 1100 patients hospitalised for AHF and who had iron deficiency ID defined as serum ferritin <100 ng/mL or 100-299 ng/mL if transferrin saturation <20%. Eligible patients were randomised (1:1) to either i.v. FCM or placebo and received the first dose of study treatment just prior to discharge for the index hospitalisation. Patients will be followed for 52 weeks. The primary outcome is the composite of recurrent HF hospitalisations and CV mortality. The main secondary outcomes include the composite of recurrent CV hospitalisations and CV mortality, recurrent HF hospitalisations and safety-related outcomes.
CONCLUSION


The AFFIRM-AHF trial will evaluate, compared to placebo, the effect of i.v. FCM on morbidity and mortality in iron-deficient patients hospitalised for AHF.",2019,"The main secondary outcomes include the composite of recurrent CV hospitalisations and CV mortality, recurrent HF hospitalisations and safety-related outcomes.
","['1100 patients hospitalised for AHF and who had iron deficiency ID defined as serum ferritin <100\u2009ng/mL or 100-299', 'patients hospitalised for acute HF (AHF', 'iron-deficient patients hospitalised for AHF', 'stable HF patients with reduced ejection fraction', 'iron-deficient patients admitted for acute heart failure']","['FCM or placebo', 'FCM (vs. placebo', 'FCM', 'ferric carboxymaltose (FCM', 'placebo', 'iron supplementation', 'intravenous ferric carboxymaltose']","['composite of recurrent HF hospitalisations and CV mortality', 'functional capacity, symptoms and quality of life', 'hospitalisations and mortality', 'composite of recurrent CV hospitalisations and CV mortality, recurrent HF hospitalisations and safety-related outcomes', 'recurrent HF hospitalisations and cardiovascular (CV) mortality', 'morbidity and mortality']","[{'cui': 'C4517537', 'cui_str': 'One thousand one hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C0240066', 'cui_str': 'Iron deficiency (disorder)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",1100.0,0.73917,"The main secondary outcomes include the composite of recurrent CV hospitalisations and CV mortality, recurrent HF hospitalisations and safety-related outcomes.
","[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Department of Heart Diseases, Wrocław Medical University, Wrocław, Poland.'}, {'ForeName': 'Bridget-Anne', 'Initials': 'BA', 'LastName': 'Kirwan', 'Affiliation': 'Department of Clinical Research, SOCAR Research SA, Nyon, Switzerland.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK); and Berlin Institute of Health Center for Regenerative Therapies (BCRT); German Centre for Cardiovascular Research (DZHK) partner site Berlin; Charité Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dorobantu', 'Affiliation': 'Cardiology Department, Emergency Hospital of Bucharest, Bucharest, Romania.'}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Drozdz', 'Affiliation': 'Klinika Kardiologii, Uniwersytet Medyczny w Łodzi, Lodz, Poland.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Fabien', 'Affiliation': 'Vifor Pharma, Opfikon, Switzerland.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'Department of Cardiology, Heart Failure Unit, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Teba', 'Initials': 'T', 'LastName': 'Haboubi', 'Affiliation': 'Vifor Pharma, Opfikon, Switzerland.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Keren', 'Affiliation': 'Assuta Hashalom Heart Institute, Assuta Hospitals, Tel-Aviv, Israel.'}, {'ForeName': 'Irakli', 'Initials': 'I', 'LastName': 'Khintibidze', 'Affiliation': 'Aleksandre Aladashvili Clinic, LLC, Tbilisi, Georgia.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Kragten', 'Affiliation': 'Molenberglaan, Heerlen, The Netherlands.'}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'Universidad Nacional de Córdoba, International Society of Cardiovascular Pharmacotherapy, Córdoba, Argentina.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'McDonagh', 'Affiliation': ""King's College Hospital, London, UK.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Cardiology, University of Brescia and Civil Hospital, Brescia, Italy.'}, {'ForeName': 'Davor', 'Initials': 'D', 'LastName': 'Milicic', 'Affiliation': 'University Hospital Centre Zagreb, Zagreb, Croatia.'}, {'ForeName': 'José C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Faculdade de Medicina FMUSP, Instituto do Coracao (InCor), Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Ohlsson', 'Affiliation': 'Department of Nephrology and Transplantation, Skane University Hospital Malmoe, Malmo, Sweden.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Parhomenko', 'Affiliation': 'The M.D. Strazhesko Institute of Cardiology, Kyiv, Ukraine.'}, {'ForeName': 'Domingo A', 'Initials': 'DA', 'LastName': 'Pascual-Figal', 'Affiliation': 'Cardiology Department, Hospital Virgen de la Arrixaca, University of Murcia, Murcia, Spain.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Ruschitzka', 'Affiliation': 'UniversitätsSpietal Zürich, Klinik für Kardiologie, Zürich, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sim', 'Affiliation': 'National Heart Centre, Clinical Translational and Research Office, Singapore, Singapore.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Skouri', 'Affiliation': 'American University of Beirut, Medical Center Beirut, Beirut, Lebanon.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van der Meer', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Ewa A', 'Initials': 'EA', 'LastName': 'Jankowska', 'Affiliation': 'Department of Heart Diseases, Wrocław Medical University, Wrocław, Poland.'}]",European journal of heart failure,['10.1002/ejhf.1710']
901,31842788,Continuous versus discontinuous suture in perineal injuries produced during delivery in primiparous women: a randomized controlled trial.,"BACKGROUND


The technique used in the repair of a perineal injury resulting from childbirth could avoid discomfort and morbidity during the postpartum period. Recent studies show inconsistent results and support the need for new research with the inclusion of new health parameters not yet studied. Therefore, this study aims to evaluate if the suture technique (continuous or interrupted) has an effect on pain and other postpartum problems, incidence of incontinence (urinary and/or fecal), and the restart of sexual relations.
METHODS


A single-blind randomized clinical trial was conducted in five hospitals in south-east Spain. The participants were primiparous women who had experienced a perineal injury during delivery (second-degree tear or episiotomy). Data was collected on sociodemographic variables, variables associated with pregnancy, labor and delivery, and the postpartum period, and outcomes during the 3 months after delivery: pain, incontinence, and restart of sexual relations. Odds ratios (OR) were calculated by binary logistic regression to assess the influence of the suture type on binary outcomes and t-test used for comparing continuous outcomes. Multivariate analyses (using logistic regression -adjusted (aOR)- and analysis of covariance) were carried out to adjust for unbalanced variables after randomization.
RESULTS


A total of 70 women were included in the intervention group (continuous suture) and 64 in the reference group (interrupted sutures). A negative association was observed (aOR = 0.39; 95% CI = 0.18-0.86) between a continuous suture and the need for analgesia at 24 h postpartum. Pain experienced by the women at 24 h postpartum was assessed as 4.4 ± 0.3 compared with a score of 3.4 ± 0.3 in the group with continuous sutures (p = 0.011). At 15 days postpartum, women in the intervention group experienced less pain (aOR = 0.38; 95% CI = 0.18-0.80) (p = 0.019). Urinary sphincter incontinence was also evaluated at 15 days, with 4.3% (n = 3) of the women in the intervention group presenting with urinary incontinence compared with 18.8% (n = 12) in the control group (aOR = 0.11; 95% CI = 0.03-0.47) (P = 0.003).
CONCLUSIONS


The women who had a continuous suture repair showed lower levels of pain from delivery to 3 months after delivery and had a lower incidence of urinary incontinence at 15 days postpartum.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03825211 posted January 31, 2019 (retrospectively registered).",2019,"At 15 days postpartum, women in the intervention group experienced less pain (aOR = 0.38; 95% CI = 0.18-0.80) (p = 0.019).","['participants were primiparous women who had experienced a perineal injury during delivery (second-degree tear or episiotomy', 'primiparous women', 'five hospitals in south-east Spain', 'A total of 70 women were included in the intervention group (continuous suture) and 64 in the reference group (interrupted sutures']","['discontinuous suture', 'continuous suture repair', 'suture technique (continuous or interrupted']","['pregnancy, labor and delivery, and the postpartum period, and outcomes during the 3\u2009months after delivery: pain, incontinence, and restart of sexual relations', 'Pain', 'pain and other postpartum problems, incidence of incontinence (urinary and/or fecal', 'urinary incontinence', 'pain', 'levels of pain', 'Urinary sphincter incontinence', 'Odds ratios (OR']","[{'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3544174', 'cui_str': 'Perineal injury'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0443298', 'cui_str': 'Second degree (qualifier value)'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}]","[{'cui': 'C0439599', 'cui_str': 'Discontinuous (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0038968', 'cui_str': 'Suture Technics'}]","[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",70.0,0.23148,"At 15 days postpartum, women in the intervention group experienced less pain (aOR = 0.38; 95% CI = 0.18-0.80) (p = 0.019).","[{'ForeName': 'Juan Miguel', 'Initials': 'JM', 'LastName': 'Martínez-Galiano', 'Affiliation': 'Department of Nursing, University of Jaen, Jaen, Spain. juanmimartinezg@hotmail.com.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Arredondo-López', 'Affiliation': 'Andalusian Health Service, Jaen, Spain.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Molina-Garcia', 'Affiliation': 'Andalusian Health Service, Jaen, Spain.'}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Cámara-Jurado', 'Affiliation': 'Andalusian Health Service, Jaen, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Cocera-Ruiz', 'Affiliation': 'Andalusian Health Service, Jaen, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Rodríguez-Delgado', 'Affiliation': 'Consortium for Biomedical Research in Epidemiology and Public Health (CIBERESP), Madrid, Spain.'}]",BMC pregnancy and childbirth,['10.1186/s12884-019-2655-2']
902,29954931,"A phase II/III randomized, multicenter trial of prednisone/sirolimus  versus  prednisone/ sirolimus/calcineurin inhibitor for the treatment of chronic graft- versus -host disease: BMT CTN 0801.","Initial therapy of chronic graft- versus -host disease is prednisone ± a calcineurin-inhibitor, but most patients respond inadequately. In a randomized, adaptive, phase II/III, multicenter trial we studied whether prednisone/sirolimus or prednisone/sirolimus/photopheresis was more effective than prednisone/sirolimus/calcineurin-inhibitor for treating chronic graft- versus -host disease in treatment-naïve or early inadequate responders. Primary endpoints of this study were proportions of subjects alive without relapse or secondary therapy with 6-month complete or partial response in phase II, or with 2-year complete response in phase III. The prednisone/sirolimus/photopheresis arm closed prematurely because of slow accrual and the remaining two-drug  versus  three-drug study ended in phase II due to statistical futility with 138 evaluable subjects. The two-drug and three-drug arms did not differ in rates of 6-month complete or partial response (48.6%  versus  50.0%,  P =0.87), or 2-year complete response (14.7%  versus  15.5%,  P =0.90). Serum creatinine values >1.5 times baseline were less frequent in the calcineurin-inhibitor-free arm at 2 months (1.5%  versus  11.7%,  P =0.025) and 6 months (7.8%  versus  24.0%,  P =0.016). Higher adjusted Short Form-36 Physical Component Summary and Physical Functioning scores were seen in the two-drug arm at both 2 months ( P =0.02 and  P =0.04, respectively) and 6 months ( P =0.007 and  P =0.001, respectively). Failure-free survival and overall survival rates at 2 years were similar for patients in the the two-drug and three-drug arms (48.6%  versus  46.2%,  P =0.78; 81.5%  versus  74%,  P =0.28). Based on similar long-term outcomes, prednisone/sirolimus is a therapeutic alternative to prednisone/sirolimus/calcineurin-inhibitor for chronic graft- versus -host disease, being easier to administer and better tolerated.  Clinicaltrials.gov identifier: NCT01106833.",2018,"Failure-free survival and overall survival rates at 2 years were similar for patients in the the two-drug and three-drug arms (48.6%  versus  46.2%,  P =0.78; 81.5%  versus  74%,  P =0.28).",['138 evaluable subjects'],"['prednisone/sirolimus/calcineurin-inhibitor', 'prednisone/sirolimus', 'prednisone/sirolimus or prednisone/sirolimus/photopheresis', 'prednisone/sirolimus/photopheresis', 'prednisone/sirolimus  versus  prednisone/ sirolimus/calcineurin inhibitor']","['Serum creatinine values', 'Failure-free survival and overall survival rates', 'proportions of subjects alive without relapse or secondary therapy with 6-month complete or partial response in phase II, or with 2-year complete response', 'Form-36 Physical Component Summary and Physical Functioning scores', '2-year complete response', 'rates of 6-month complete or partial response']",[],"[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}, {'cui': 'C0206373', 'cui_str': 'Photochemotherapy, Extracorporeal'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",138.0,0.044931,"Failure-free survival and overall survival rates at 2 years were similar for patients in the the two-drug and three-drug arms (48.6%  versus  46.2%,  P =0.78; 81.5%  versus  74%,  P =0.28).","[{'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Carpenter', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA pcarpent@fredhutch.org.'}, {'ForeName': 'Brent R', 'Initials': 'BR', 'LastName': 'Logan', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Weisdorf', 'Affiliation': 'University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Johnston', 'Affiliation': 'Stanford Hospital and Clinics, Stanford, CA.'}, {'ForeName': 'Luciano J', 'Initials': 'LJ', 'LastName': 'Costa', 'Affiliation': 'University of Alabama at Birmingham, AL.'}, {'ForeName': 'Carrie L', 'Initials': 'CL', 'LastName': 'Kitko', 'Affiliation': 'Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Bolaños-Meade', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Sarantopoulos', 'Affiliation': 'Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Amin M', 'Initials': 'AM', 'LastName': 'Alousi', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Abhyankar', 'Affiliation': 'The University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Edmund K', 'Initials': 'EK', 'LastName': 'Waller', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Mendizabal', 'Affiliation': 'The Emmes Corporation, Rockville, MD.'}, {'ForeName': 'Jiaxi', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'The Emmes Corporation, Rockville, MD.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': ""O'Brien"", 'Affiliation': 'The Emmes Corporation, Rockville, MD.'}, {'ForeName': 'Aleksandr', 'Initials': 'A', 'LastName': 'Lazaryan', 'Affiliation': 'University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'The Emmes Corporation, Rockville, MD.'}, {'ForeName': 'Eneida R', 'Initials': 'ER', 'LastName': 'Nemecek', 'Affiliation': 'Oregon Health and Sciences University, Portland, OR.'}, {'ForeName': 'Steven Z', 'Initials': 'SZ', 'LastName': 'Pavletic', 'Affiliation': 'Experimental Transplantation and Immunology Branch, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Corey S', 'Initials': 'CS', 'LastName': 'Cutler', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Horowitz', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Mukta', 'Initials': 'M', 'LastName': 'Arora', 'Affiliation': 'University of Minnesota, Minneapolis, MN.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Haematologica,['10.3324/haematol.2018.195123']
903,31766216,New Zealand Bitter Hops Extract Reduces Hunger During a 24 h Water Only Fast.,"Intermittent fasting improves metabolic and cardiac health. However, increased hunger towards the end of the fasting period may affect compliance and limit its application. Our aim was to determine the effect of anorexigenic agent co-therapy on subjective ratings of appetite during the 16-24 h period of a day-long water-only intermittent fast. Thirty adult men were recruited and required to fast for 24 h from 18:00 h to 18:00 h on the same day of the week for three subsequent weeks. Treatments of either a placebo or one of two doses (high dose; HD: 250 mg or low dose; LD: 100 mg) of a bitter hops-based appetite suppressant (Amarasate®) were given twice per day at 16 and 20 h into the fast. From 18-24 h of the 24 h fast, both the HD and LD treatment groups exhibited a statistically significant ( p  < 0.05) > 10% reduction in hunger. Additionally, the expected lunchtime increase in hunger that was present in the placebo group (12:00 h) was absent in both the HD and LD groups. These data suggest that appetite suppressant co-therapy may be useful in reducing hunger during intermittent fasting, and show that bitter compounds may regulate appetite independently of meal timing.",2019,"From 18-24 h of the 24 h fast, both the HD and LD treatment groups exhibited a statistically significant ( p  < 0.05) > 10% reduction in hunger.",['Thirty adult men'],"['placebo', 'bitter hops-based appetite suppressant (Amarasate®', 'anorexigenic agent co-therapy']","['metabolic and cardiac health', 'subjective ratings of appetite', 'Hunger', 'hunger']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4018995', 'cui_str': 'Hop'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0003620', 'cui_str': 'Appetite Suppressants'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}]",30.0,0.0634686,"From 18-24 h of the 24 h fast, both the HD and LD treatment groups exhibited a statistically significant ( p  < 0.05) > 10% reduction in hunger.","[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Walker', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Auckland 1025, New Zealand.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Lo', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Auckland 1025, New Zealand.'}, {'ForeName': 'Sze', 'Initials': 'S', 'LastName': 'Tham', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Palmerston North 4442, New Zealand.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Pahl', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Auckland 1025, New Zealand.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Lomiwes', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Palmerston North 4442, New Zealand.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Cooney', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Hamilton 3240, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wohlers', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Auckland 1025, New Zealand.'}, {'ForeName': 'Pramod', 'Initials': 'P', 'LastName': 'Gopal', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Palmerston North 4442, New Zealand.'}]",Nutrients,['10.3390/nu11112754']
904,31766250,"Effect of Micronutrient Powder (MNP) with a Low-Dose of Iron on Hemoglobin and Iron Biomarkers, and Its Effect on Morbidities in Rural Bangladeshi Children Drinking Groundwater with a High-Level of Iron: A Randomized Controlled Trial.","Micronutrient Powder (MNP) is beneficial to control anemia, but some iron-related side-effects are common. A high level of iron in the groundwater used for drinking may exacerbate the side-effects among MNP users. We conducted a randomized controlled trial examining the effect of a low-dose iron MNP compared with the standard MNP in children aged 2-5 years residing in a high-groundwater-iron area in rural Bangladesh. We randomized 327 children, who were drinking from the ""high-iron"" wells (≥2 mg/L), to receive either standard (12.5 mg iron) or low-dose iron (5.0 mg iron) MNP, one sachet per day for two months. Iron parameters were measured both at baseline and end-point. The children were monitored weekly for morbidities. A generalized linear model was used to determine the treatment effect of the low-dose iron MNP. Poisson regressions were used to determine the incidence rate ratios of the morbidities. The trial was registered at ISRCTN60058115. Changes in the prevalence of anemia (defined as a hemoglobin level < 11.0 g/dL) were 5.4% (baseline) to 1.0% (end-point) in the standard MNP; and 5.8% (baseline) to 2.5% (end-point) in the low-dose iron MNP groups. The low-dose iron MNP was non-inferior to the standard MNP on hemoglobin outcome (β = -0.14, 95% CI: -0.30, 0.013;  p  = 0.07). It resulted in a lower incidence of diarrhea (IRR = 0.29,  p  = 0.01, 95% CI: 0.11-0.77), nausea (IRR = 0.24,  p  = 0.002, 95% CI: 0.09-0.59) and fever (IRR = 0.26,  p  < 0.001, 95% CI: 0.15-0.43) compared to the standard MNP. Low-dose iron MNP was non-inferior to the standard MNP in preventing anemia yet demonstrated an added advantage of lowering the key side-effects.",2019,Low-dose iron MNP was non-inferior to the standard MNP in preventing anemia yet demonstrated an added advantage of lowering the key side-effects.,"['Rural Bangladeshi Children Drinking Groundwater with a High-Level of Iron', 'children aged 2-5 years residing in a high-groundwater-iron area in rural Bangladesh', '327 children, who were drinking from the ""high-iron"" wells (≥2 mg/L']","['Micronutrient Powder (MNP', 'low-dose iron MNP', 'standard MNP', 'Low-dose iron MNP', 'standard (12.5 mg iron) or low-dose iron (5.0 mg iron) MNP']","['incidence rate ratios of the morbidities', 'prevalence of anemia', 'fever', 'diarrhea', 'hemoglobin outcome', 'nausea']","[{'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0596631', 'cui_str': 'Underground Water'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0439268', 'cui_str': 'microgram/mL'}]","[{'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",327.0,0.204233,Low-dose iron MNP was non-inferior to the standard MNP in preventing anemia yet demonstrated an added advantage of lowering the key side-effects.,"[{'ForeName': 'Sabuktagin', 'Initials': 'S', 'LastName': 'Rahman', 'Affiliation': 'Public Health, School of Medicine, Griffith University, Gold Coast Campus, QLD 4220, Australia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Lee', 'Affiliation': 'Public Health, School of Medicine, Griffith University, Gold Coast Campus, QLD 4220, Australia.'}, {'ForeName': 'Rubhana', 'Initials': 'R', 'LastName': 'Raqib', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Mohakhali Dhaka 1212, Bangladesh.'}, {'ForeName': 'Anjan K', 'Initials': 'AK', 'LastName': 'Roy', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Mohakhali Dhaka 1212, Bangladesh.'}, {'ForeName': 'Moududur R', 'Initials': 'MR', 'LastName': 'Khan', 'Affiliation': 'Institute of Nutrition and Food Science, University of Dhaka, Dhaka 1000, Bangladesh.'}, {'ForeName': 'Faruk', 'Initials': 'F', 'LastName': 'Ahmed', 'Affiliation': 'Public Health, School of Medicine, Griffith University, Gold Coast Campus, QLD 4220, Australia.'}]",Nutrients,['10.3390/nu11112756']
905,31848765,Telephone-Delivered Mindfulness Training to Promote Medication Adherence and Reduce Sexual Risk Behavior Among Persons Living with HIV: An Exploratory Clinical Trial.,"This study explored whether telephone-delivered mindfulness training (MT) to promote medication adherence and reduce sexual risk behavior was feasible for and acceptable to people living with HIV. Participants (N = 42; 50% female; M age = 47.5 years) were randomized to MT or health coaching (HC). Pre- and post-intervention, and at 3-month follow-up, we assessed adherence to ART, sexual risk behavior, and hypothesized mediators; we also conducted individual interviews to obtain qualitative data. Results showed that 55% of patients assigned to MT completed ≥ 50% of the training calls compared with 86% of HC patients (p < .05). Most patients reported satisfaction with their intervention (MT = 88%, HC = 87%). Patients in MT and HC reported improvements in medication adherence, mindfulness, and sexual risk reduction as well as reductions in anxiety, depressive symptoms, perceived stress, and impulsivity over time; however, no between-groups differences were observed.",2020,"Patients in MT and HC reported improvements in medication adherence, mindfulness, and sexual risk reduction as well as reductions in anxiety, depressive symptoms, perceived stress, and impulsivity over time; however, no between-groups differences were observed.","['people living with HIV', 'Participants (N\u2009=\u200942; 50% female; M age\u2009=\u200947.5\xa0years', 'Persons Living with HIV']","['telephone-delivered mindfulness training (MT', 'MT or health coaching (HC', 'Telephone-Delivered Mindfulness Training']","['Sexual Risk Behavior', 'anxiety, depressive symptoms, perceived stress, and impulsivity over time', 'adherence to ART, sexual risk behavior, and hypothesized mediators', 'medication adherence, mindfulness, and sexual risk reduction']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",,0.0292532,"Patients in MT and HC reported improvements in medication adherence, mindfulness, and sexual risk reduction as well as reductions in anxiety, depressive symptoms, perceived stress, and impulsivity over time; however, no between-groups differences were observed.","[{'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Carey', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, CORO West, Suite 309, 164 Summit Avenue, Providence, RI, 02903, USA. Michael_Carey@brown.edu.'}, {'ForeName': 'Eugene M', 'Initials': 'EM', 'LastName': 'Dunne', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, CORO West, Suite 309, 164 Summit Avenue, Providence, RI, 02903, USA.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Norris', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, CORO West, Suite 309, 164 Summit Avenue, Providence, RI, 02903, USA.'}, {'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Dunsiger', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, CORO West, Suite 309, 164 Summit Avenue, Providence, RI, 02903, USA.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Rich', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, CORO West, Suite 309, 164 Summit Avenue, Providence, RI, 02903, USA.'}, {'ForeName': 'Rochelle K', 'Initials': 'RK', 'LastName': 'Rosen', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, CORO West, Suite 309, 164 Summit Avenue, Providence, RI, 02903, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Chan', 'Affiliation': 'Department of Behavioral and Social Science, School of Public Health, Brown University, Providence, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Salmoirago-Blotcher', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, CORO West, Suite 309, 164 Summit Avenue, Providence, RI, 02903, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02768-2']
906,31852444,Effects of alternate-day fasting on body weight and dyslipidaemia in patients with non-alcoholic fatty liver disease: a randomised controlled trial.,"BACKGROUND


Alternate-day fasting (ADF) is a novel diet therapy that may achieve reduction in body weight and improvement of dyslipidaemia, but the impact of this diet on patients with non-alcoholic fatty liver disease (NAFLD) remains unknown. The aim of this study was to evaluate the effects of ADF on the body weight and lipid profile of individuals with NAFLD.
METHODS


NAFLD patients (n = 271) were randomised to the ADF group, time-restricted feeding (TRF) group, or the control group and subjected to the respective diet for 12 weeks. Anthropometric measurements (body weight, fat mass/fat-free mass) were performed, and plasma lipids were analysed enzymatically.
RESULTS


Within 4 weeks, the body weight decreased significantly (P < 0.001) in the ADF group by 4.56 ± 0.41 kg (6.1 ± 0.5%) and the TRF group by 3.62 ± 0.65 kg (4.83 ± 0.9%) compared to the control group, and it decreased even more after 12 weeks in both groups (ADF: - 4.04 ± 0.54 kg, 5.4 ± 0.7%; TRF: - 3.25 ± 0.67 kg, 4.3 ± 0.9%). Fat mass was significantly reduced by ADF (- 3.49 ± 0.37 kg; 11 ± 1.2%) and TRF (- 2.91 ± 0.41 kg; 9.6 ± 1.3%), with ADF leading to a further reduction in fat mass after 12 weeks (- 3.48 ± 0.38 kg; 11 ± 1.2%). Total cholesterol was significantly decreased at both time points in the ADF group (- 0.91 ± 0.07 mmol/L; 18.5 ± 1.5%) compared to the control and TRF groups. Both ADF (- 0.64 ± 0.06 mmol/L; 25 ± 1.9%) and TRF (0.58 ± 0.07 mmol/L; 20 ± 1.7%) achieved a significant reduction in serum triglycerides (P < 0.001) after 12 weeks. Changes in fat free mass, HDL, LDL, fasting insulin, glucose, liver stiffness, and systolic or diastolic blood pressure did not differ between the groups.
CONCLUSIONS


ADF appears to be an effective diet therapy for individuals with NAFLD that can achieve weight loss and improvement of dyslipidaemia within a relatively short period of time (4 to 12 weeks). Potential preventive effects of ADF on cardiovascular disease need to be confirmed by future investigations.
TRIAL REGISTRATION


ChiCTR1900024411, this trial was retrospectively registered on July 10, 2019.",2019,Total cholesterol was significantly decreased at both time points in the ADF group (- 0.91 ± 0.07 mmol/L; 18.5 ± 1.5%) compared to the control and TRF groups.,"['NAFLD patients (n\u2009=\u2009271', 'patients with non-alcoholic fatty liver disease (NAFLD', 'patients with non-alcoholic fatty liver disease', 'individuals with NAFLD']","['ADF group, time-restricted feeding (TRF', 'alternate-day fasting', 'ADF']","['body weight', 'fat free mass, HDL, LDL, fasting insulin, glucose, liver stiffness, and systolic or diastolic blood pressure', 'Total cholesterol', 'body weight and lipid profile', 'body weight and improvement of dyslipidaemia', 'weight loss and improvement of dyslipidaemia', 'Fat mass', 'body weight and dyslipidaemia', 'Anthropometric measurements (body weight, fat mass/fat-free mass', 'serum triglycerides']","[{'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0040162', 'cui_str': 'protirelin'}, {'cui': 'C0558287', 'cui_str': 'Alternate days (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1869029', 'cui_str': 'Dyslipidaemia (SMQ)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}]",,0.0356463,Total cholesterol was significantly decreased at both time points in the ADF group (- 0.91 ± 0.07 mmol/L; 18.5 ± 1.5%) compared to the control and TRF groups.,"[{'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': ""Department of Gastroenterology, Hunan Provincial People' Hospital, The First Affiliated Hospital of Human Normal University, Jiefang Road West, Changsha, 410005, Hunan, China.""}, {'ForeName': 'Yue-Lan', 'Initials': 'YL', 'LastName': 'Qin', 'Affiliation': ""Department of Gastroenterology, Hunan Provincial People' Hospital, The First Affiliated Hospital of Human Normal University, Jiefang Road West, Changsha, 410005, Hunan, China.""}, {'ForeName': 'Ze-Ya', 'Initials': 'ZY', 'LastName': 'Shi', 'Affiliation': ""Department of Gastroenterology, Hunan Provincial People' Hospital, The First Affiliated Hospital of Human Normal University, Jiefang Road West, Changsha, 410005, Hunan, China.""}, {'ForeName': 'Jin-Hui', 'Initials': 'JH', 'LastName': 'Chen', 'Affiliation': ""Department of Gastroenterology, Hunan Provincial People' Hospital, The First Affiliated Hospital of Human Normal University, Jiefang Road West, Changsha, 410005, Hunan, China.""}, {'ForeName': 'Min-Jie', 'Initials': 'MJ', 'LastName': 'Zeng', 'Affiliation': ""Department of Gastroenterology, Hunan Provincial People' Hospital, The First Affiliated Hospital of Human Normal University, Jiefang Road West, Changsha, 410005, Hunan, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': ""Department of Gastroenterology, Hunan Provincial People' Hospital, The First Affiliated Hospital of Human Normal University, Jiefang Road West, Changsha, 410005, Hunan, China.""}, {'ForeName': 'Ru-Qun', 'Initials': 'RQ', 'LastName': 'Chen', 'Affiliation': ""Department of Gastroenterology, Hunan Provincial People' Hospital, The First Affiliated Hospital of Human Normal University, Jiefang Road West, Changsha, 410005, Hunan, China.""}, {'ForeName': 'Zhi-Yuan', 'Initials': 'ZY', 'LastName': 'Chen', 'Affiliation': ""Department of Gastroenterology, Hunan Provincial People' Hospital, The First Affiliated Hospital of Human Normal University, Jiefang Road West, Changsha, 410005, Hunan, China. chenzhiyuan@hunnu.edu.cn.""}]",BMC gastroenterology,['10.1186/s12876-019-1132-8']
907,31844886,"Safety and efficacy of VB-111, an anticancer gene therapy, in patients with recurrent glioblastoma: results of a phase I/II study.","BACKGROUND


VB-111 is a non-replicating adenovirus carrying a Fas-chimera transgene, leading to targeted apoptosis of tumor vascular endothelium and induction of a tumor-specific immune response. This phase I/II study evaluated the safety, tolerability, and efficacy of VB-111 with and without bevacizumab in recurrent glioblastoma (rGBM).
METHODS


Patients with rGBM (n = 72) received VB-111 in 4 treatment groups: subtherapeutic (VB-111 dose escalation), limited exposure (LE; VB-111 monotherapy until progression), primed combination (VB-111 monotherapy continued upon progression with combination of bevacizumab), and unprimed combination (upfront combination of VB-111 and bevacizumab). The primary endpoint was median overall survival (OS). Secondary endpoints were safety, overall response rate, and progression-free survival (PFS).
RESULTS


VB-111 was well tolerated. The most common adverse event was transient mild-moderate fever. Median OS time was significantly longer in the primed combination group compared with both LE (414 vs 223 days; hazard ratio [HR], 0.48; P = 0.043) and unprimed combination (414 vs 141.5 days; HR, 0.24; P = 0.0056). Patients in the combination phase of the primed combination group had a median PFS time of 90 days compared with 60 in the LE group (HR, 0.36; P = 0.032), and 63 in the unprimed combination group (P = 0.72). Radiographic responders to VB-111 exhibited characteristic, expansive areas of necrosis in the areas of initial enhancing disease.
CONCLUSIONS


Patients with rGBM who were primed with VB-111 monotherapy that continued after progression with the addition of bevacizumab showed significant survival and PFS advantage, as well as specific imaging characteristics related to VB-111 mechanism of action. These results warrant further assessment in a randomized controlled study.",2020,"Median OS time was significantly longer in the Primed Combination group compared to both LE (414 vs 223 days; HR 0.48; p=0.043), and Unprimed Combination (414 vs. 141.5 days; HR 0.24; p=0.0056); Patients in the combination phase of the Primed Combination group had a median PFS time of 90 days compared to 60 in the LE group (HR 0.36; p=0.032), and 63 in the Unprimed Combination group (p=0.72).","['patients with recurrent glioblastoma', 'Patients with rGBM', 'Patients with rGBM (n=72) received', 'recurrent glioblastoma (rGBM']","['bevacizumab', 'VB-111', 'Unprimed Combination (upfront combination of VB-111 and bevacizumab', 'Sub-Therapeutic (VB-111 dose escalation), Limited Exposure (LE, VB-111 monotherapy until progression), Primed Combination ', 'VB-111 with and without bevacizumab']","['median PFS time', 'safety, tolerability and efficacy', 'Median OS time', 'median overall survival (OS', 'safety, overall response rate, and progression-free survival (PFS', 'tolerated', 'survival and PFS advantage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0889918,"Median OS time was significantly longer in the Primed Combination group compared to both LE (414 vs 223 days; HR 0.48; p=0.043), and Unprimed Combination (414 vs. 141.5 days; HR 0.24; p=0.0056); Patients in the combination phase of the Primed Combination group had a median PFS time of 90 days compared to 60 in the LE group (HR 0.36; p=0.032), and 63 in the Unprimed Combination group (p=0.72).","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Brenner', 'Affiliation': 'University of Texas Health San Antonio Mays Cancer Center, San Antonio, Texas, USA.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Peters', 'Affiliation': 'Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Vredenburgh', 'Affiliation': 'Saint Francis Hospital and Medical Center, Hartford, Connecticut, USA.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Bokstein', 'Affiliation': 'Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Deborah T', 'Initials': 'DT', 'LastName': 'Blumenthal', 'Affiliation': 'Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Shlomit', 'Initials': 'S', 'LastName': 'Yust-Katz', 'Affiliation': 'Neuro-Oncology Unit, Davidoff Cancer Center at Rabin Medical Center, Petach Tikvah, Israel and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Idit', 'Initials': 'I', 'LastName': 'Peretz', 'Affiliation': 'Neuro-Oncology Unit, Davidoff Cancer Center at Rabin Medical Center, Petach Tikvah, Israel and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Bernice', 'Initials': 'B', 'LastName': 'Oberman', 'Affiliation': 'Biostatistics and Biomathematics Unit, Gertner Institute for Epidemiology and Health Policy Research, Chaim Sheba Medical Center, Tel Hashomer, Israel.'}, {'ForeName': 'Laurence S', 'Initials': 'LS', 'LastName': 'Freedman', 'Affiliation': 'Biostatistics and Biomathematics Unit, Gertner Institute for Epidemiology and Health Policy Research, Chaim Sheba Medical Center, Tel Hashomer, Israel.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Ellingson', 'Affiliation': 'UCLA Brain Tumor Imaging Laboratory, Center for Computer Vision and Imaging Biomarkers, Department of Radiological Sciences, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Cloughesy', 'Affiliation': 'Department of Neurology, Ronald Reagan UCLA Medical Center, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Naamit', 'Initials': 'N', 'LastName': 'Sher', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Yael C', 'Initials': 'YC', 'LastName': 'Cohen', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Lowenton-Spier', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Rachmilewitz Minei', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Niva', 'Initials': 'N', 'LastName': 'Yakov', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Itzhak', 'Initials': 'I', 'LastName': 'Mendel', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Breitbart', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Patrick Y', 'Initials': 'PY', 'LastName': 'Wen', 'Affiliation': 'Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}]",Neuro-oncology,['10.1093/neuonc/noz231']
908,31844890,A randomized controlled phase III study of VB-111 combined with bevacizumab vs bevacizumab monotherapy in patients with recurrent glioblastoma (GLOBE).,"BACKGROUND


Ofranergene obadenovec (VB-111) is an anticancer viral therapy that demonstrated in a phase II study a survival benefit for patients with recurrent glioblastoma (rGBM) who were primed with VB-111 monotherapy that was continued after progression with concomitant bevacizumab.
METHODS


This pivotal phase III randomized, controlled trial compared the efficacy and safety of upfront combination of VB-111 and bevacizumab versus bevacizumab monotherapy. Patients were randomized 1:1 to receive VB-111 1013 viral particles every 8 weeks in combination with bevacizumab 10 mg/kg every 2 weeks (combination arm) or bevacizumab monotherapy (control arm). The primary endpoint was overall survival (OS), and secondary endpoints were objective response rate (ORR) by Response Assessment in Neuro-Oncology (RANO) criteria and progression-free survival (PFS).
RESULTS


Enrolled were 256 patients at 57 sites. Median exposure to VB-111 was 4 months. The study did not meet its primary or secondary goals. Median OS was 6.8 versus 7.9 months in the combination versus control arm (hazard ratio, 1.20; 95% CI: 0.91-1.59; P = 0.19) and ORR was 27.3% versus 21.9% (P = 0.26). A higher rate of grades 3-5 adverse events was reported in the combination arm (67% vs 40%), mainly attributed to a higher rate of CNS and flu-like/fever events. Trends for improved survival with combination treatment were seen in the subgroup of patients with smaller tumors and in patients who had a posttreatment febrile reaction.
CONCLUSIONS


In this study, upfront concomitant administration of VB-111 and bevacizumab failed to improve outcomes in rGBM. Change of treatment regimen, with the lack of VB-111 monotherapy priming, may explain the differences from the favorable phase II results.
CLINICAL TRIALS REGISTRATION


NCT02511405.",2020,A higher rate of grade 3-5 Adverse Events was reported in the combination arm (67% vs 40%) mainly attributed to a higher rate of CNS and flu-like/fever events.,"['patients with recurrent glioblastoma (rGBM', 'patients with recurrent glioblastoma (GLOBE', '256 patients were enrolled at 57 sites']","['bevacizumab', 'VB-111 and bevacizumab versus bevacizumab monotherapy', 'VB-111 1013 viral particles q8W in combination with bevacizumab 10mg/Kg q2W (combination arm) or bevacizumab monotherapy (control arm', 'VB-111 and bevacizumab', 'VB-111 combined with bevacizumab vs. bevacizumab monotherapy']","['survival', 'rate of CNS and flu-like/fever events', 'overall survival (OS', 'objective response rate (ORR) by RANO and Progression Free Survival (PFS', 'efficacy and safety', 'ORR', 'Median OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0042760', 'cui_str': 'Viral Particles'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",256.0,0.111146,A higher rate of grade 3-5 Adverse Events was reported in the combination arm (67% vs 40%) mainly attributed to a higher rate of CNS and flu-like/fever events.,"[{'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Cloughesy', 'Affiliation': 'Department of Neurology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Brenner', 'Affiliation': 'University of Texas Health San Antonio Cancer Center, San Antonio, Texas, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'de Groot', 'Affiliation': 'Department of Neuro-Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Butowski', 'Affiliation': 'Department of Neurological Surgery, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Leor', 'Initials': 'L', 'LastName': 'Zach', 'Affiliation': 'Oncology Institute, Chaim Sheba Medical Center, Tel HaShomer, Israel.'}, {'ForeName': 'Jian L', 'Initials': 'JL', 'LastName': 'Campian', 'Affiliation': 'Division of Medical Oncology, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Ellingson', 'Affiliation': 'UCLA Brain Tumor Imaging Laboratory, Center for Computer Vision and Imaging Biomarkers, Department of Radiological Sciences, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Laurence S', 'Initials': 'LS', 'LastName': 'Freedman', 'Affiliation': 'Biostatistics and Biomathematics Unit, Gertner Institute for Epidemiology and Health Policy Research, Chaim Sheba Medical Center, Tel HaShomer, Israel.'}, {'ForeName': 'Yael C', 'Initials': 'YC', 'LastName': 'Cohen', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Lowenton-Spier', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Rachmilewitz Minei', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Shifra', 'Initials': 'S', 'LastName': 'Fain Shmueli', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Patrick Y', 'Affiliation': 'Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}]",Neuro-oncology,['10.1093/neuonc/noz232']
909,29146543,"Cardiac resynchronisation therapy optimisation of interventricular delay by the systolic dyssynchrony index: A comparative, randomised, 12-month follow-up study.","BACKGROUND


The aim of our study was to compare the effect of interventricular (VV) delay optimisation in CRT recipients on the basis of systolic dyssynchrony index (SDI) derived from the three-dimensional echocardiography (3DE) versus QRS width assessment on left ventricle volume reduction at the 12-month follow-up.
METHODS


We included 63 patients with recently implanted CRT in this randomised, open-label trial. Patients were randomised to VV delay optimisation according to QRS complex width measurement in group 1 (n = 31) to obtain the narrowest QRS complex and SDI in group 2 (n = 32) to achieve its lowest possible value. We evaluated left ventricular end-systolic volume (LVESv), left ventricular ejection fraction (LVEF) and SDI by 3DE before CRT implantation and at a 12-month follow-up in all the patients. We also obtained the New York Heart Association functional class, the 6-minute walk test, the quality of life questionnaire and the level of NT-proBNP.
RESULTS


The number of volumetric responders was similar in both groups (17 vs. 20, P = 0.786). There were also no significant differences in the reduction of LVESv (-41 ± 55 mL vs. - 61 ± 51 mL, P = 0.111), improvement in LVEF (+10.1 ± 10.6% vs. + 13.0 ± 9.9%, P = 0.213) or differences in clinical outcomes between both groups at the 12-month follow-up.
CONCLUSION


CRT optimisation of interventricular delay using SDI compared with QRS width assessment did not reveal any significant difference in terms of volumetric and clinical response at the 12-month follow-up.",2019,"The number of volumetric responders was similar in both groups (17 vs. 20, P = 0.786).",['63 patients with recently'],"['VV delay optimisation according to QRS complex width measurement in group 1 (n\xa0=\xa031) to obtain the narrowest QRS complex and SDI', 'implanted CRT', 'Cardiac resynchronisation therapy']","['quality of life questionnaire and the level of NT-proBNP', 'systolic dyssynchrony index (SDI', 'number of volumetric responders', 'improvement in LVEF', 'left ventricular end-systolic volume (LVESv), left ventricular ejection fraction (LVEF) and SDI by 3DE before CRT implantation', 'reduction of LVESv', 'volumetric and clinical response', 'systolic dyssynchrony index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C0429097', 'cui_str': 'QRS complex feature'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0429027', 'cui_str': 'Narrow QRS complex (finding)'}, {'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}]","[{'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0445383', 'cui_str': 'Volumetric (qualifier value)'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",63.0,0.0425646,"The number of volumetric responders was similar in both groups (17 vs. 20, P = 0.786).","[{'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Vondrak', 'Affiliation': 'Department of Cardiology, Pardubice Regional Hospital a.s., Pardubice, Czech Republic. Electronic address: jiri.vondrak@centrum.cz.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Marek', 'Affiliation': 'Department of Internal Medicine I - Cardiology, Faculty of Medicine and Dentistry, Olomouc, Czech Republic; Department of Internal Medicine, Hospital Prerov, SMN a.s., Prerov, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Vecera', 'Affiliation': 'Department of Cardiology, Pardubice Regional Hospital a.s., Pardubice, Czech Republic; Cardiology Center, Agel a.s., Pardubice, Czech Republic.'}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Benesova', 'Affiliation': 'Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Matejka', 'Affiliation': 'Department of Cardiology, Pardubice Regional Hospital a.s., Pardubice, Czech Republic; Cardiology Center, Agel a.s., Pardubice, Czech Republic.'}]",Hellenic journal of cardiology : HJC = Hellenike kardiologike epitheorese,['10.1016/j.hjc.2017.11.003']
910,31268266,Impact of spinal needle design and approach to postdural puncture headache and spinal anesthesia failure in obstetrics.,"BACKGROUND


Concern has been raised that Sprotte needles predispose to spinal anes-thesia failure. Nevertheless, these needles are associated with a low incidence of postdural puncture headache. The impact of the paramedian approach to postdural puncture headache remains controversial. The objective of this prospective randomized study was to compare Sprotte, Quincke and Atraucan needles as well as the midline and the paramedian approach in terms of postdural puncture headache and spinal anesthesia failure in patients undergoing Caesarean section.
METHODS


655 patients were randomized to 5 groups. A midline approach was used in four groups. The spinal needles were the 25G Sprotte, 27G Sprotte, 26G Atraucan and 25G Quincke. In the fifth group a 25G Quincke needle was used by the paramedian approach.
RESULTS


The incidence of postdural puncture headache was 0% in both 25G and 27G Sprotte groups, 2.5% in the 26G Atraucan group, and 7.2% and 2.7% in the 25G Quincke midline and paramedian approach respectively. A significant difference in terms of postdural puncture headache was found between 25G Sprotte and 25G Quincke needles (P = 0.004), while the failure rate was similar between these two needles. A significant difference in spinal anesthesia failure rate was observed between midline and paramedian approaches (P = 0.041).
CONCLUSIONS


Sprotte but not Atraucan needle design correlates with lower incidence of postdural puncture headache compared to Quincke design. Sprotte needles are not associated with a higher spinal anesthesia failure compared to Quincke needles. The incidence of postdural puncture headache by the paramedian approach is not significantly reduced whereas the spinal anesthesia failure rate is increased in comparison to the midline approach.",2019,"A significant difference in spinal anesthesia failure rate was observed between midline and paramedian approaches (P = 0.041).
","['postdural puncture headache and spinal anesthesia failure in obstetrics', 'patients undergoing Caesarean section', '655 patients']",[],"['spinal anesthesia failure rate', 'failure rate', 'postdural puncture headache and spinal anesthesia failure', 'spinal anesthesia failure', 'postdural puncture headache']","[{'cui': 'C0751188', 'cui_str': 'Post-Dural Puncture Headaches'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]",[],"[{'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0751188', 'cui_str': 'Post-Dural Puncture Headaches'}]",655.0,0.0183527,"A significant difference in spinal anesthesia failure rate was observed between midline and paramedian approaches (P = 0.041).
","[{'ForeName': 'Roumiana', 'Initials': 'R', 'LastName': 'Batova', 'Affiliation': ""Department of Anesthesiology and Intensive Care, University Hospital of Obstetrics and Gynecology 'Maichin Dom', Medical University, Sofia, Bulgaria.""}, {'ForeName': 'Silvi', 'Initials': 'S', 'LastName': 'Georgiev', 'Affiliation': ""Department of Anesthesiology and Intensive Care, University Hospital of Obstetrics and Gynecology 'Maichin Dom', Medical University, Sofia, Bulgaria.""}]",Anaesthesiology intensive therapy,['10.5114/ait.2019.86166']
911,31268273,Relationship between the regurgitated and the aspirated volume of water. A manikin study.,"BACKGROUND


The relationship between gastric fluid volume, volume of fluid regurgitated, and aspirated fluid volume remains unclear. Using a life-like manikin suitable for a pulmonary aspiration model, we aimed to assess the relationship between regurgitated and aspirated clear fluid volumes, and to determine the minimal value of the volume of liquid regurgitated that may lead to pulmonary aspiration of fluid volume ≥ 0.8 mL kg-1 (around 60 mL) that is likely to cause lung injury.
METHODS


Several volumes of water ranging from 30 to 150 mL were injected in a randomized order, at a flow rate of 20 mL per second, into the esophagus of a manikin lying in the supine position on a non-tilted table, with the manikin head in the extension or in the sniffing position. Aspirated volumes were measured in the manikin bronchi, by an investigator blinded to the volume injected. Aspiration was defined as positive when the volume of collected water was ≥ 60 mL for at least one of the five injections of each volume of water.
RESULTS


The minimal volume of water injected into the esophagus for an aspirated volume ≥ 0.8 mL kg-1 was 85 mL in the sniffing position, and was 150 mL in the extension position.
CONCLUSIONS


These results suggest that the critical cut-off value of gastric fluid volume to be considered for the risk of significant pulmonary aspiration would be ≥ 85 mL (≥ 1 mL kg-1), in the sniffing position. These results should however be confirmed in further studies using other models.",2019,"The minimal volume of water injected into the esophagus for an aspirated volume ≥ 0.8 mL kg-1 was 85 mL in the sniffing position, and was 150 mL in the extension position.
",['Several volumes of water ranging from 30 to 150 mL'],"['manikin lying in the supine position on a\xa0non-tilted table, with the manikin head in the extension or in the sniffing position']",[],"[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C0038846', 'cui_str': 'Dorsal Position'}, {'cui': 'C1706074', 'cui_str': 'Table'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}]",[],,0.0684872,"The minimal volume of water injected into the esophagus for an aspirated volume ≥ 0.8 mL kg-1 was 85 mL in the sniffing position, and was 150 mL in the extension position.
","[{'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Bouvet', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Hospices Civils de Lyon, Femme Mère Enfant Hospital, Bron, France.'}, {'ForeName': 'Eloïse', 'Initials': 'E', 'LastName': 'Cercueil', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Hospices Civils de Lyon, Femme Mère Enfant Hospital, Bron, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Barnoud', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Hospices Civils de Lyon, Femme Mère Enfant Hospital, Bron, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Lilot', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Hospices Civils de Lyon, Femme Mère Enfant Hospital, Bron, France.'}, {'ForeName': 'François-Pierrick', 'Initials': 'FP', 'LastName': 'Desgranges', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Hospices Civils de Lyon, Femme Mère Enfant Hospital, Bron, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Chassard', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Hospices Civils de Lyon, Femme Mère Enfant Hospital, Bron, France.'}]",Anaesthesiology intensive therapy,['10.5114/ait.2019.85953']
912,31303184,Iron status and inherited haemoglobin disorders modify the effects of micronutrient powders on linear growth and morbidity among young Lao children in a double-blind randomised trial.,"Some studies found that providing micronutrient powder (MNP) causes adverse health outcomes, but modifying factors are unknown. We aimed to investigate whether Fe status and inherited Hb disorders (IHbD) modify the impact of MNP on growth and diarrhoea among young Lao children. In a double-blind controlled trial, 1704 children of age 6-23 months were randomised to daily MNP (with 6 mg Fe plus fourteen micronutrients) or placebo for about 36 weeks. IHbD, and baseline and final Hb, Fe status and anthropometrics were assessed. Caregivers provided weekly morbidity reports. At enrolment, 55·6 % were anaemic; only 39·3 % had no sign of clinically significant IHbD. MNP had no overall impact on growth and longitudinal diarrhoea prevalence. Baseline Hb modified the effect of MNP on length-for-age (LAZ) (P for interaction = 0·082). Among children who were initially non-anaemic, the final mean LAZ in the MNP group was slightly lower (-1·93 (95 % CI -1·88, -1·97)) v. placebo (-1·88 (95 % CI -1·83, -1·92)), and the opposite occurred among initially anaemic children (final mean LAZ -1·90 (95 % CI -1·86, -1·94) in MNP v. -1·92 (95 % CI -1·88, -1·96) in placebo). IHbD modified the effect on diarrhoea prevalence (P = 0·095). Among children with IHbD, the MNP group had higher diarrhoea prevalence (1·37 (95 % CI 1·17, 1·59) v. 1·21 (95 % CI 1·04, 1·41)), while it was lower among children without IHbD who received MNP (1·15 (95 % CI 0·95, 1·39) v. 1·37 (95 % CI 1·13, 1·64)). In conclusion, there was a small adverse effect of MNP on growth among non-anaemic children and on diarrhoea prevalence among children with IHbD.",2019,"Among children with IHbD, the MNP group had higher diarrhea prevalence (1.37 (95%CI: 1.17, 1.59) vs. 1.21 (95%CI: 1.04, 1.41)), while it was lower among children without IHbD who received MNP (1.15 (95%CI: 0.95, 1.39) vs. 1.37 (95%CI: 1.13, 1.64)).","['Young Lao Children', 'children with IHbD', '1704 children ages 6-23mo', 'young Lao children']","['placebo', 'micronutrient powder (MNP', '95%CI', 'daily MNP (with 6mg iron plus 14 micronutrients) or placebo', 'Micronutrient Powders', 'MNP']","['Linear Growth and Morbidity', 'IHbD, and baseline and final hemoglobin (Hb), iron status, and anthropometrics', 'growth and longitudinal diarrhea prevalence', 'growth and diarrhea', 'diarrhea prevalence']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0534702', 'cui_str': 'lanthanum oxide'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",1704.0,0.679542,"Among children with IHbD, the MNP group had higher diarrhea prevalence (1.37 (95%CI: 1.17, 1.59) vs. 1.21 (95%CI: 1.04, 1.41)), while it was lower among children without IHbD who received MNP (1.15 (95%CI: 0.95, 1.39) vs. 1.37 (95%CI: 1.13, 1.64)).","[{'ForeName': 'Sonja Y', 'Initials': 'SY', 'LastName': 'Hess', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'K Ryan', 'Initials': 'KR', 'LastName': 'Wessells', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Guy-Marino', 'Initials': 'GM', 'LastName': 'Hinnouho', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Maxwell A', 'Initials': 'MA', 'LastName': 'Barffour', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Kanokwan', 'Initials': 'K', 'LastName': 'Sanchaisuriya', 'Affiliation': 'Center for Research and Development of Medical Diagnostic Laboratories, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Brown', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Charles P', 'Initials': 'CP', 'LastName': 'Larson', 'Affiliation': 'Canadian Coalition for Global Health Research, Ottawa, Canada.'}, {'ForeName': 'Supan', 'Initials': 'S', 'LastName': 'Fucharoen', 'Affiliation': 'Center for Research and Development of Medical Diagnostic Laboratories, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Sengchanh', 'Initials': 'S', 'LastName': 'Kounnavong', 'Affiliation': ""Lao Tropical and Public Health Institute, Vientiane, Lao People's Democratic Republic.""}]",The British journal of nutrition,['10.1017/S0007114519001715']
913,31320290,"Tenofovir disoproxil fumarate intravaginal ring for HIV pre-exposure prophylaxis in sexually active women: a phase 1, single-blind, randomised, controlled trial.","BACKGROUND


An intravaginal ring that releases the tenofovir prodrug, tenofovir disoproxil fumarate, provided 100% protection in macaques against simian HIV and was safe in a 14-day clinical trial in sexually abstinent women. We aimed to assess the safety and pharmacokinetics of this intravaginal ring over 90 days in sexually active women.
METHODS


We did a phase 1, single-blind, randomised, placebo-controlled trial to assess safety, pharmacokinetics, and acceptability of a tenofovir disoproxil fumarate intravaginal ring used continuously with monthly ring changes for 3 months. Sexually active women who were HIV negative were randomly assigned (3:1) to a tenofovir disoproxil fumarate ring or placebo ring. Primary safety endpoint was the proportion of women who had grade 2 or higher genitourinary adverse events judged related to study product and any grade 2 or higher adverse event as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. We quantified tenofovir disoproxil fumarate and tenofovir concentrations in cervicovaginal fluid, tenofovir in plasma, and tenofovir diphosphate, the active metabolite, in cervical tissue and dried blood spots 1 month after each ring insertion. We compared changes over time in cervicovaginal fluid cytokine and chemokine concentrations and vaginal microbiota. The study was electively stopped early and is registered with ClinicalTrials.gov, number NCT02762617.
FINDINGS


Between Feb 24 and July 20, 2017, 17 women were enrolled before study termination. 12 were assigned to receive the tenofovir disoproxil fumarate ring and five were assigned to receive the placebo ring. Two participants in the tenofovir disoproxil fumarate ring group completed 3 months of continuous ring use; eight were asked to discontinue ring use early because of ulcerations (grade 1) near the ring; in the remaining two women, rings were electively removed by study staff on day 20 and day 23. Ulcers were detected a mean of 32 days after ring use (range 23-56). Four of eight participants with ulcers were symptomatic with vaginal discharge; four had ulcers identified when examined; three had two ulcers; all ulcers resolved after ring removal. No participants in the placebo group developed ulcers. No grade 2 product-related adverse events were reported in either group and four non-product-related grade 2 adverse events were reported in the tenofovir disoproxil fumarate ring group. Cervicovaginal fluid tenofovir concentrations did not differ at day 14 (p=0·14) comparing the eight patients who did (median 1·0 × 10 5  ng/mL [IQR 9·1 × 10 4 -1·1 × 10 5 ]) with the four who did not (6·0 × 10 4  ng/mL [5·6 × 10 4 -1·1 × 10 5 ]) develop ulcers. No significant changes in vaginal microbiota were detected in either group. Concentrations of multiple inflammatory cytokines and chemokines were significantly higher at days 14 and 28 compared with baseline in the tenofovir disoproxil fumarate ring group but not the placebo group.
INTERPRETATION


Future studies are needed to establish whether the unanticipated finding of ulcerations is specific to this tenofovir disoproxil fumarate ring or generalisable to other sustained topical release formulations of tenofovir or its prodrugs.
FUNDING


National Institutes of Health.",2019,Cervicovaginal fluid tenofovir concentrations did not differ at day 14 (p=0·14) comparing the eight patients who did (median 1·0 × 10,"['10 5 ]) with the four who did not (6·0', 'sexually abstinent women', 'Sexually active women who were HIV negative', 'Between Feb 24 and July 20, 2017', '17 women were enrolled before study termination', 'sexually active women']","['tenofovir disoproxil fumarate', 'tenofovir', 'tenofovir disoproxil fumarate ring or placebo ring', 'placebo', 'Tenofovir disoproxil fumarate intravaginal ring for HIV pre-exposure prophylaxis', 'tenofovir disoproxil fumarate and tenofovir', 'tenofovir prodrug, tenofovir disoproxil fumarate', 'placebo ring', 'tenofovir disoproxil fumarate intravaginal']","['grade 2 product-related adverse events', 'Cervicovaginal fluid tenofovir concentrations', 'ulcers', 'Concentrations of multiple inflammatory cytokines and chemokines', 'Ulcers', 'safety, pharmacokinetics, and acceptability', 'proportion of women who had grade 2 or higher genitourinary adverse events judged related to study product and any grade 2 or higher adverse event as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events', 'safety and pharmacokinetics', 'vaginal microbiota']","[{'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C4520512', 'cui_str': 'Sexually abstinent (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C1260969', 'cui_str': 'Ring, device (physical object)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal (qualifier value)'}, {'cui': 'C1096319', 'cui_str': 'HIV pre-exposure prophylaxis'}, {'cui': 'C0033262', 'cui_str': 'Drug Precursors'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0221191', 'cui_str': 'Judge (occupation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1293097', 'cui_str': 'Division - action (qualifier value)'}, {'cui': 'C1706074', 'cui_str': 'Table'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",17.0,0.405657,Cervicovaginal fluid tenofovir concentrations did not differ at day 14 (p=0·14) comparing the eight patients who did (median 1·0 × 10,"[{'ForeName': 'Marla J', 'Initials': 'MJ', 'LastName': 'Keller', 'Affiliation': 'Department of Medicine, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Lianna', 'Initials': 'L', 'LastName': 'Wood', 'Affiliation': 'Department of Pediatrics, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Billingsley', 'Affiliation': 'Yerkes National Primate Research Center, Atlanta, GA, USA.'}, {'ForeName': 'Laurie L', 'Initials': 'LL', 'LastName': 'Ray', 'Affiliation': 'Department of Medicine, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Goymer', 'Affiliation': 'Department of Pediatrics, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Shada', 'Initials': 'S', 'LastName': 'Sinclair', 'Affiliation': 'Department of Pediatrics, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Aileen P', 'Initials': 'AP', 'LastName': 'McGinn', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Marzinke', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Frank', 'Affiliation': 'Particle Sciences, Bethlehem, PA, USA.'}, {'ForeName': 'Sujatha', 'Initials': 'S', 'LastName': 'Srinivasan', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Congzhou', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Atrio', 'Affiliation': ""Department of Obstetrics and Gynecology and Women's Health, Albert Einstein College of Medicine, Bronx, NY, USA.""}, {'ForeName': 'Lilia', 'Initials': 'L', 'LastName': 'Espinoza', 'Affiliation': 'Department of Medicine, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Nelly', 'Initials': 'N', 'LastName': 'Mugo', 'Affiliation': 'Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Hans M L', 'Initials': 'HML', 'LastName': 'Spiegel', 'Affiliation': 'Division of AIDS, Kelly Government Solutions, Contractor to National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, Rockville, MD, USA.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Anderson', 'Affiliation': 'Department of Pharmaceutical Sciences, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO, USA.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Fredricks', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Craig W', 'Initials': 'CW', 'LastName': 'Hendrix', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Marrazzo', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Bosinger', 'Affiliation': 'Yerkes National Primate Research Center, Atlanta, GA, USA.'}, {'ForeName': 'Betsy C', 'Initials': 'BC', 'LastName': 'Herold', 'Affiliation': 'Department of Pediatrics, Albert Einstein College of Medicine, Bronx, NY, USA. Electronic address: betsy.herold@einstein.yu.edu.'}]",The lancet. HIV,['10.1016/S2352-3018(19)30145-6']
914,31309910,"Associations between sweet taste function, oral complex carbohydrate sensitivity, liking and consumption of  ad libitum  sweet and non-sweet carbohydrate milkshakes among female adults.","Excess energy intake is recognised as a strong contributing factor to the global rise of being overweight and obese. The aim of this paper was to investigate if oral sensitivity to complex carbohydrate relates to ad libitum consumption of complex carbohydrate foods in a sample group of female adults. Participants' ((n 51 females): age 23·0 (sd 0·6) years (range 20·0-41·0 years); excluding restrained eaters) sensitivity towards maltodextrin (oral complex carbohydrate) and glucose (sweet taste) was assessed by measuring detection threshold (DT) and suprathreshold intensity perception (ST). A crossover design was used to assess consumption of two different iso-energetic preload milkshakes and ad libitum milkshakes - (1) glucose-based milkshake, (2) maltodextrin-based milkshake. Ad libitum intake (primary outcome) and eating rate, liking, hunger, fullness and prospective consumption ratings were measured. Participants who were more sensitive towards complex carbohydrate (maltodextrin DT) consumed significantly more maltodextrin-based milkshake in comparison with less-sensitive participants (P = 0·01) and this was independent of liking. Participants who had higher liking for glucose-based milkshake consumed significantly more glucose-based milkshake in comparison with participants with lower hedonic ratings (P = 0·049). The results provide support regarding the role of the oral system sensitivity (potentially taste) to complex carbohydrate and the prospective to overconsume complex carbohydrate-based milkshake in a single sitting.",2019,Participants who were more sensitive towards complex carbohydrate (maltodextrin DT) consumed significantly more maltodextrin based milkshake in comparison to less sensitive participants (P=0.01) and this was independent of liking.,"['female adults', 'a sample group of female adults', ""Participants' [(n = 51 females): age 23.0 ± 0.6 years (range 20.0 - 41.0 years); excluding restrained eaters] sensitivity towards""]","['caloric preload milkshakes and ad libitum milkshakes - 1) glucose based milkshake, 2) maltodextrin based milkshake', 'complex carbohydrate (maltodextrin DT', 'maltodextrin', 'sweet taste function, oral complex carbohydrate sensitivity, liking and consumption of ad libitum sweet and non-sweet carbohydrate milkshakes', 'maltodextrin (oral complex carbohydrate) and glucose (sweet taste']","['eating rate, liking, hunger, fullness, and prospective consumption ratings', 'hedonic ratings', 'detection threshold (DT) and suprathreshold intensity perception (ST']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0556154', 'cui_str': 'Complex carbohydrate (substance)'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}]","[{'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0349783,Participants who were more sensitive towards complex carbohydrate (maltodextrin DT) consumed significantly more maltodextrin based milkshake in comparison to less sensitive participants (P=0.01) and this was independent of liking.,"[{'ForeName': 'Julia Y Q', 'Initials': 'JYQ', 'LastName': 'Low', 'Affiliation': 'Centre for Advanced Sensory Science, School of Exercise and Nutrition Sciences, Deakin University, Burwood, Victoria 3125, Australia.'}, {'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Lacy', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Victoria 3220, Australia.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'McBride', 'Affiliation': 'Centre for Advanced Sensory Science, School of Exercise and Nutrition Sciences, Deakin University, Burwood, Victoria 3125, Australia.'}, {'ForeName': 'Russell S J', 'Initials': 'RSJ', 'LastName': 'Keast', 'Affiliation': 'Centre for Advanced Sensory Science, School of Exercise and Nutrition Sciences, Deakin University, Burwood, Victoria 3125, Australia.'}]",The British journal of nutrition,['10.1017/S0007114519001703']
915,31337448,"Protein supplementation combined with low-intensity resistance training in geriatric medical patients during and after hospitalisation: a randomised, double-blind, multicentre trial.","Sarcopenia (loss of muscle mass/strength) burdens many older adults - hospitalised older adults being particularly vulnerable. Treating the condition, protein supplementation (PrS) and resistance training (RT) may act synergistically. Therefore, this block-randomised, double-blind, multicentre intervention study, recruiting geriatric patients > 70 years from three medical departments, investigated the effect of PrS combined with RT during hospitalisation and 12 weeks after discharge. Participants were randomly allocated (1:1) to receive PrS (totally 27·5 g whey protein/d, about 2000 kJ/d) or isoenergetic placebo-products (< 1·5 g protein/d) divided into two servings per d to supplement the habitual diet. Both groups were engaged in a standardised, progressive low-intensity RT programme for the lower extremities (hospital: supervised daily/after discharge: self-training 4×/week). From April 2016 to September 2017, 2351 patients were screened, 462 were eligible, and 165 included. Fourteen were excluded and ten dropped out, leaving 141 participants in the intention-to-treat analysis. The average total protein intake during hospitalisation/after discharge was 1·0 (interquartile range (IQR) 0·8, 1·3)/1·1 (IQR 0·9, 1·3) g/kg per d (protein-group) and 0·6 (IQR 0·5, 0·8)/0·9 (IQR 0·6, 1·0) g/kg per d (placebo group). Both groups improved significantly for the primary and secondary endpoints of muscle mass/strength, functional measurements and quality of life, but no additional effect of PrS was seen for the primary endpoint (30-s chair stand test, repetitions, median changes from baseline: (standard test: 0 (IQR 0, 5) (protein group) v. 2 (IQR 0, 6) (placebo group) and modified test: 2 (IQR 0, 5) (protein group) v. 2 (IQR -1, 5) (placebo group)) or any secondary endpoints (Mann-Whitney U tests, P > 0·05). In conclusion, PrS increasing the total protein intake by 0·4 and 0·2 g/kg per d during hospitalisation and after discharge, respectively, does not seem to increase the adaptive response to low-intensity RT in geriatric medical patients.",2019,"In conclusion, PrS increasing total protein intake by 0.4 and 0.2 g/kg/d during hospitalization and after discharge, respectively, does not seem to increase the adaptive response to low intensity/volume RT in geriatric medical patients.","['geriatric medical patients during and after hospitalization', 'older adults - hospitalized older adults', 'geriatric patients &gt;70 years from three Medical Departments', 'geriatric medical patients']","['protein-supplementation (PrS) and resistance-training (RT', 'PrS combined with RT', 'Protein supplementation combined with low-intensity resistance training', 'PrS (totally 27.5 g whey protein/day, ≈2000 kJ/day) or iso-energetic placebo']",['total protein intake'],"[{'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0587450', 'cui_str': 'Medical department (environment)'}]","[{'cui': 'C0770246', 'cui_str': 'Protein supplement'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0456646', 'cui_str': 'kilojoules/day'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0555903', 'cui_str': 'Total protein measurement'}]",,0.287345,"In conclusion, PrS increasing total protein intake by 0.4 and 0.2 g/kg/d during hospitalization and after discharge, respectively, does not seem to increase the adaptive response to low intensity/volume RT in geriatric medical patients.","[{'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Gade', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Copenhagen University, 2200 Copenhagen, Denmark.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Beck', 'Affiliation': 'Dietetics and Clinical Nutrition Research Unit, Herlev and Gentofte Hospital, 2730 Herlev, Denmark.'}, {'ForeName': 'Hanne E', 'Initials': 'HE', 'LastName': 'Andersen', 'Affiliation': 'Medical Department M, Rigshospitalet-Glostrup, 2600 Glostrup, Denmark.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'Christensen', 'Affiliation': 'Arla Foods Amba, 8260 Viby, Denmark.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Rønholt', 'Affiliation': 'Medical Department, Herlev and Gentofte Hospital, 2730 Herlev, Denmark.'}, {'ForeName': 'Tobias W', 'Initials': 'TW', 'LastName': 'Klausen', 'Affiliation': 'Department of Haematology, Herlev and Gentofte Hospital, 2730 Herlev, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Vinther', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy and QD-Research Unit, Herlev and Gentofte Hospital, 2730 Herlev, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Copenhagen University, 2200 Copenhagen, Denmark.'}]",The British journal of nutrition,['10.1017/S0007114519001831']
916,32406746,[High intensity interval training increases the utilization of fatty acids in subjects with overweight or obesity. A randomized study].,"INTRODUCTION


the effect of high intensity interval training (HIIT) on fat utilization during exercise needs to be studied in depth.
OBJECTIVE


to determine the effect of HIIT training program in subjects with overweight or obesity on the use of fat during exercise, body composition and cardiovascular variables. The second objective was to compare the variables according to the duration of the program (i.e., 12, 16 and 20 weeks).
MATERIAL AND METHODS


30 subjects were studied (age 44.8 ± 11.6 years). Three groups were formed at random, the G1 (12 weeks, n = 12, 48.08 ± 8.20 years), G2 (16 weeks, n = 10, 42.10 ± 11.60 years) and G3 (20 weeks, n = 8, 43.38 ± 15.76 years). All groups performed HIIT 3 times per week.
RESULTS


the three groups showed a significant decrease in body fat percentage (p < 0.05), without differences between groups. Similarly, cardiovascular variables did not report differences between groups (p-interaction > 0.05) after the intervention; however, the groups reported a significant decrease systolic blood pressure (p < 0, 05). In the pre vs. post analysis by groups, the three groups showed improvements in VO2max without differences between groups (p-interaction > 0.05). Finally, the three groups increased the fats utilization during exercise (p < 0.05).
CONCLUSION


the program increased fat utilization during exercise, decreased body fat % and improved cardiovascular parameters, however after 12 training weeks it is advisable to apply variations to training to maximize results.",2020,"the three groups showed a significant decrease in body fat percentage (p < 0.05), without differences between groups.","['subjects with overweight or obesity on the use of fat during exercise, body composition and cardiovascular variables', 'subjects with overweight or obesity', '30 subjects were studied (age 44.8 ± 11.6 years']","['High intensity interval training', 'HIIT training program', 'high intensity interval training (HIIT']","['fats utilization', 'body fat percentage', 'fat utilization during exercise, decreased body fat % and improved cardiovascular parameters', 'VO2max', 'systolic blood pressure', 'utilization of fatty acids', 'cardiovascular variables']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",30.0,0.0214989,"the three groups showed a significant decrease in body fat percentage (p < 0.05), without differences between groups.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Moris', 'Affiliation': 'Departamento de Educación Física, Deportes y Recreación. Universidad de la Frontera.'}, {'ForeName': 'Pedro Antonio', 'Initials': 'PA', 'LastName': 'Delgado Floody', 'Affiliation': 'Departamento de Educación Física, Deportes y Recreación. Universidad de la Frontera.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Martínez Salazar', 'Affiliation': 'Departamento de Educación Física, Deportes y Recreación. Universidad de la Frontera.'}]",Nutricion hospitalaria,['10.20960/nh.02940']
917,4619395,"Double blind trial of mefenamic acid, aspirin and placebo in patients with post-operative pain.",,1974,,['patients with post-operative pain'],"['mefenamic acid, aspirin and placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0025152', 'cui_str': 'Mefenamic Acid'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.2691,,"[{'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Vaidya', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Sheth', 'Affiliation': ''}, {'ForeName': 'K K', 'Initials': 'KK', 'LastName': 'Manghani', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Shroff', 'Affiliation': ''}, {'ForeName': 'K K', 'Initials': 'KK', 'LastName': 'Vora', 'Affiliation': ''}, {'ForeName': 'U K', 'Initials': 'UK', 'LastName': 'Sheth', 'Affiliation': ''}]",Indian journal of medical sciences,[]
918,31334882,"Impact of web-based learning for health program planning competency, knowledge and skills among mid-level public health nurses: A randomized controlled trial.","OBJECTIVES


To evaluate the impact of web-based learning modules for health program planning competency, recognition, knowledge and skills among mid-level public health nurses (PHNs).
DESIGN


Parallel-group randomized controlled trial.
SAMPLE


During 2018, 244 Japanese PHNs were eligible as participants with 5-20 years experiences as a PHN were randomly allocated to the intervention (n = 121) or control group (n = 123).
MEASUREMENTS


The outcome was assessed using the Competency Measurement of Creativity for PHNs (CMC) and 26 questions about recognition, knowledge, and skills for health program planning.
INTERVENTIONS


Eight web-based modules.
RESULTS


No significant differences in CMC scores between the control and intervention groups at base line and post-intervention. By contrast, significant differences in total score of the 26 items of knowledge and skills. In an exploratory analysis, there was a significant difference identified in CMC scores in the demographic of post graduate training in program planning at base line and post-intervention. (p = .034).
CONCLUSIONS


The findings suggested that web-based learning with flexibility in terms of time and location would improve competency, skills and knowledge of health program planning among mid-level PHNs.",2019,"The findings suggested that web-based learning with flexibility in terms of time and location would improve competency, skills and knowledge of health program planning among mid-level PHNs.","['mid-level public health nurses (PHNs', 'mid-level public health nurses', 'During 2018, 244 Japanese PHNs were eligible as participants with 5-20\xa0years experiences as a PHN']",[],"['CMC scores', 'total score', 'Competency Measurement of Creativity for PHNs (CMC) and 26 questions about recognition, knowledge, and skills for health program planning']","[{'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034022', 'cui_str': 'Public Health Nurses'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0010297', 'cui_str': 'Creative Thinking'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}]",244.0,0.0519518,"The findings suggested that web-based learning with flexibility in terms of time and location would improve competency, skills and knowledge of health program planning among mid-level PHNs.","[{'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Yoshioka-Maeda', 'Affiliation': 'Department of Health Promotion, National Institute of Public Health, Saitama, Japan.'}, {'ForeName': 'Misa', 'Initials': 'M', 'LastName': 'Shiomi', 'Affiliation': 'Department of Community Health Nursing, School of Nursing, College of Nursing Art and Science, University of Hyogo, Hyogo, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Katayama', 'Affiliation': 'Department of Statistic and Computer Science, College of Nursing Art and Science, University of Hyogo, Hyogo, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Hosoya', 'Affiliation': 'Department of Community Health Nursing, School of Nursing, Chiba Prefectural University of Health Sciences, Chiba, Japan.'}]","Public health nursing (Boston, Mass.)",['10.1111/phn.12642']
919,31327625,Ocular surface response and subjective symptoms associated to lens care solutions in Palestine.,"PURPOSE


To compare the biocompatibility and subjective symptoms of four multipurpose solutions marketed in Palestine with hydrogel contact lenses.
METHODS


50 habitual soft contact lens wearers were recruited in this interventional crossover study. Subjects were asked to attend the optometry clinic five times. A new pair of hydrogel lenses (Bioxifilcon-B) were fitted each time. This pair was soaked randomly overnight in one of the following four-multipurpose solutions (NEOPLUS ® , AvizorUnicaSensitive ® , ReNuMultiPlus ®  and COMPLETERevitaLens ® ) which contain different disinfecting agents (PHMB, Phx, PAPB, and PQ-1+Alexidine, respectively), or non-preserved saline. At each visit, corneal staining, ocular redness and subjective symptoms were assessed.
RESULTS


The percentage of corneal staining increased significantly (P≤0.050) after soaking the lenses with PHMB (86%), PAPB (64%) and Phx (32%) based-solutions. However, a non-significant increase was noticed after the use of PQ-1+Alexidine based solution (30%, P=0.083). Ocular redness evaluation showed a significant increase (P≤0.050) in limbal hyperemia after the use of all solutions, while bulbar redness was significantly increased after the use of biguanide-based solutions (P≤0.050). The subjective assessment analysis showed a non-significant change in comfort, dryness, photophobia and scratchiness (P≥0.050) at 2-h intervention using all solutions, except for the PHMB based solution which showed a significant change in subjective symptoms (P≤0.050).
CONCLUSION


The combination of Bioxifilcon-B hydrogel contact lenses and solution containing PHMB, PAPB and Phx-disinfectants induced a significant increase in corneal staining after 2h of CL-wear with a higher severity when the PHMB-based solution was used, while the PQ-1+Alexidine-based solution did not. Only the PHMB-based solution triggered a significant change in subjective symptoms which might which suggests that it might be related to the severity of staining rather than the induction of staining.",2019,"The percentage of corneal staining increased significantly (P≤0.050) after soaking the lenses with PHMB (86%), PAPB (64%) and Phx (32%) based-solutions.","['Palestine', '50 habitual soft contact lens wearers']","['hydrogel lenses (Bioxifilcon-B', 'Bioxifilcon-B hydrogel contact lenses and solution containing PHMB, PAPB and Phx-disinfectants', 'PQ-1+Alexidine']","['subjective symptoms', 'Ocular surface response and subjective symptoms', 'corneal staining', 'percentage of corneal staining', 'bulbar redness', 'comfort, dryness, photophobia and scratchiness', 'limbal hyperemia', 'corneal staining, ocular redness and subjective symptoms', 'Ocular redness evaluation', 'biocompatibility and subjective symptoms']","[{'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0009838', 'cui_str': 'Soft Contact Lenses'}]","[{'cui': 'C0063083', 'cui_str': 'Hydrogel, Polyethylene Glycol Dimethacrylate'}, {'cui': 'C0009836', 'cui_str': 'Contact Lenses'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0084110', 'cui_str': 'polyaminopropyl biguanide'}, {'cui': 'C0012682', 'cui_str': 'Disinfectants'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern (observable entity)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0085636', 'cui_str': 'Light Sensitivity'}, {'cui': 'C0423193', 'cui_str': 'Limbal injection (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.0518076,"The percentage of corneal staining increased significantly (P≤0.050) after soaking the lenses with PHMB (86%), PAPB (64%) and Phx (32%) based-solutions.","[{'ForeName': 'Ithar M', 'Initials': 'IM', 'LastName': 'Beshtawi', 'Affiliation': 'Optometry Department, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, West Bank, Palestine. Electronic address: Ithar.Beshtawi@najah.edu.'}, {'ForeName': 'Jamal', 'Initials': 'J', 'LastName': 'Qaddomi', 'Affiliation': 'Nursing Department, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, West Bank, Palestine.'}, {'ForeName': 'Hanady', 'Initials': 'H', 'LastName': 'Khuffash', 'Affiliation': 'Optometry Department, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, West Bank, Palestine.'}, {'ForeName': 'Safa', 'Initials': 'S', 'LastName': 'El-Titi', 'Affiliation': 'Medicine Department, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, West Bank, Palestine.'}, {'ForeName': 'Malak', 'Initials': 'M', 'LastName': 'Ghannam', 'Affiliation': 'Optometry Department, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, West Bank, Palestine.'}, {'ForeName': 'Reema', 'Initials': 'R', 'LastName': 'Otaibi', 'Affiliation': 'Medicine Department, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, West Bank, Palestine.'}]",Journal of optometry,['10.1016/j.optom.2019.03.001']
920,31337877,Randomised phase 3 study of adjuvant chemotherapy with or without nadroparin in patients with completely resected non-small-cell lung cancer: the NVALT-8 study.,"BACKGROUND


Retrospective studies suggest that low molecular weight heparin may delay the development of metastasis in patients with resected NSCLC.
METHODS


Multicentre phase 3 study with patients with completely resected NSCLC who were randomised after surgery to receive chemotherapy with or without nadroparin. The main exclusion criteria were R1/2 and wedge/segmental resection. FDG-PET was required. The primary endpoint was recurrence-free survival (RFS).
RESULTS


Among 235 registered patients, 202 were randomised (nadroparin: n = 100; control n = 102). Slow accrual enabled a decrease in the number of patients needed from 600 to 202, providing 80% power to compare RFS with 94 events (α = 0.05; 2-sided). There were no differences in bleeding events between the two groups. The median RFS was 65.2 months (95% CI, 36-NA) in the nadroparin arm and 37.7 months (95% CI, 22.7-NA) in the control arm (HR 0.77 (95% CI, 0.53-1.13, P = 0.19). FDG-PET SUVmax ≥10 predicted a greater likelihood of recurrence in the first year (HR 0.48, 95% CI 0.22-0.9, P = 0.05).
CONCLUSIONS


Adjuvant nadroparin did not improve RFS in patients with resected NSCLC. In this study, a high SUVmax predicted a greater likelihood of recurrence in the first year.
CLINICAL TRIAL REGISTRATION


Netherlands Trial registry: NTR1250/1217.",2019,"FDG-PET SUVmax ≥10 predicted a greater likelihood of recurrence in the first year (HR 0.48, 95% CI 0.22-0.9, P = 0.05).
","['patients with completely resected non-small-cell lung cancer', '235 registered patients, 202 were randomised (nadroparin: n\u2009=\u2009100; control n\u2009=\u2009102', 'patients with resected NSCLC', 'patients with resected NSCLC.\nMETHODS\n\n\nMulticentre phase 3 study with patients with completely resected NSCLC who were randomised after surgery to receive']","['adjuvant chemotherapy with or without nadroparin', 'chemotherapy with or without nadroparin']","['median RFS', 'RFS', 'recurrence-free survival (RFS', 'bleeding events', 'likelihood of recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0206232', 'cui_str': 'Nadroparin'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0206232', 'cui_str': 'Nadroparin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",202.0,0.512985,"FDG-PET SUVmax ≥10 predicted a greater likelihood of recurrence in the first year (HR 0.48, 95% CI 0.22-0.9, P = 0.05).
","[{'ForeName': 'Harry J M', 'Initials': 'HJM', 'LastName': 'Groen', 'Affiliation': 'Department of Pulmonary Disease, University of Groningen and University Medical Center Groningen, Hanzeplein 1, Box 30.001, 9700 RB, Groningen, Netherlands. h.j.m.groen@umcg.nl.'}, {'ForeName': 'Erik H F M', 'Initials': 'EHFM', 'LastName': 'van der Heijden', 'Affiliation': 'Department of Pulmonary Diseases, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, Netherlands.'}, {'ForeName': 'Theo J', 'Initials': 'TJ', 'LastName': 'Klinkenberg', 'Affiliation': 'Department of Cardiothoracic Surgery, University of Groningen and University Medical Center Groningen, Hanzeplein 1, Box 30.001, 9700 RB, Groningen, Netherlands.'}, {'ForeName': 'Bonne', 'Initials': 'B', 'LastName': 'Biesma', 'Affiliation': ""Department of Pulmonary Diseases, Jeroen Bosch Hospital, Henri Dunantstraat 1, 5223 GZ, 's-Hertogenbosch, Netherlands.""}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Aerts', 'Affiliation': 'Department of Pulmonary Diseases, Erasmus Medical Center, Dr Molewaterplein 40, 3015 GD, Rotterdam, Netherlands.'}, {'ForeName': 'Ad', 'Initials': 'A', 'LastName': 'Verhagen', 'Affiliation': 'Department of Cardiothoracic Surgery, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, Netherlands.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Kloosterziel', 'Affiliation': 'Department of Pulmonary Diseases, Isala Hospital, Dokter van Heesweg 2, 8025 AB, Zwolle, Netherlands.'}, {'ForeName': 'Remge', 'Initials': 'R', 'LastName': 'Pieterman', 'Affiliation': 'Department of Pulmonary Diseases, Ommelander Hospital Group, Pastorieweg 1, 9679 BJ, Scheemda, Netherlands.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'van den Borne', 'Affiliation': 'Department of Pulmonary Diseases, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, Netherlands.'}, {'ForeName': 'Hans J M', 'Initials': 'HJM', 'LastName': 'Smit', 'Affiliation': 'Department of Pulmonary Diseases, Rijnstate Hospital, Wagnerlaan 55, 6815 AD, Arnhem, Netherlands.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Hoekstra', 'Affiliation': 'Department of Nuclear Medicine, Amsterdam University Medical Center, De Boelelaan 1117, 1081, HVAmsterdam, Netherlands.'}, {'ForeName': 'Frans M N H', 'Initials': 'FMNH', 'LastName': 'Schramel', 'Affiliation': 'Department of Pulmonary Diseases, St Antonius Hospital, Koekoekslaan 1, 3435 CM, Nieuwegein, Netherlands.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'van der Noort', 'Affiliation': 'Department of Biometrics, Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, Netherlands.'}, {'ForeName': 'Harm', 'Initials': 'H', 'LastName': 'van Tinteren', 'Affiliation': 'Department of Biometrics, Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, Netherlands.'}, {'ForeName': 'Egbert F', 'Initials': 'EF', 'LastName': 'Smit', 'Affiliation': 'Department of Thoracic Oncology, Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, Netherlands.'}, {'ForeName': 'Anne-Marie C', 'Initials': 'AC', 'LastName': 'Dingemans', 'Affiliation': 'Department of Pulmonary Diseases, Maastricht University Medical Center, P. Debijelaan 25, 6229 HX, Maastricht, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of cancer,['10.1038/s41416-019-0533-3']
921,31255521,Impact of an immunization platform in community pharmacies.,"OBJECTIVES


To assess the impact of incorporating a bidirectional immunization forecasting and reporting platform in the workflow of a regional community pharmacy chain with the use of time and motion methodologies.
SETTING


Six Bartell Drugs Pharmacies in Seattle, Washington.
PRACTICE DESCRIPTION


Bartell Drugs is a 63-store family-owned regional community pharmacy chain that offers all routine vaccinations and travel vaccinations.
PRACTICE INNOVATION


Six pharmacies were selected based on immunization performance the previous year. These pharmacies were divided into 3 immunization performance groups. Within each performance group, one store had implemented the bidirectional immunization forecasting and reporting platform (intervention) and the other had not (control).
EVALUATION


Observations were conducted for 4 to 8 hours at each store to determine the time required for each immunization encounter. Each encounter was divided into 7 time subcategories, which were assigned to the pharmacist, technician, or patient. Time and motion methodologies were used to estimate total pharmacist and technician time and the number of immunizations administered per patient encounter. All data were analyzed with the use of descriptive statistics.
RESULTS


Ten vaccinations were administered during 5 patient encounters in the intervention group compared with 8 vaccinations during 8 patient encounters in the control group. The average time spent on each patient encounter in the intervention group was 24.8 minutes, compared with 18.5 minutes in the control group. In the intervention group, pharmacists spent an average of 9.3 minutes per patient encounter compared with 7.6 minutes in the control group. In the intervention group, technicians spent an average of 10.8 minutes per encounter compared with 9.1 minutes in the control group.
CONCLUSION


Incorporation of a bidirectional immunization platform into the workflow of a community pharmacy increased staff time but also resulted in a greater number of immunizations per patient, suggesting enhanced immunization care in the intervention pharmacies.",2019,"RESULTS


Ten vaccinations were administered during 5 patient encounters in the intervention group compared with 8 vaccinations during 8 patient encounters in the control group.","['community pharmacies', 'Six Bartell Drugs Pharmacies in Seattle, Washington']",['immunization platform'],"['average time spent on each patient encounter', 'total pharmacist and technician time and the number of immunizations administered per patient encounter']","[{'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0043038', 'cui_str': 'Washington'}]","[{'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]",10.0,0.0283179,"RESULTS


Ten vaccinations were administered during 5 patient encounters in the intervention group compared with 8 vaccinations during 8 patient encounters in the control group.","[{'ForeName': 'Austin B', 'Initials': 'AB', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Bacci', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Amoo', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Ree', 'Affiliation': ''}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Firebaugh', 'Affiliation': ''}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Odegard', 'Affiliation': ''}]",Journal of the American Pharmacists Association : JAPhA,['10.1016/j.japh.2019.05.007']
922,32207984,Efficacy and Safety of Wendan Decoction for Acute Brain Injury: A Randomized Controlled Study.,"Objectives:  Despite the remarkable advances in critical care management of acute brain injury for the past 20 years, the prognoses remain poor. However, numerous reports indicate the efficacy of Traditional Chinese Medicine (TCM) therapy in stroke rehabilitation. This study aimed to determine the efficacy and safety of integrated TCM (Wendan decoction [WDD]) in patients with acute brain injury as a combination therapy in the early stages.  Design:  Prospective randomized controlled trial.  Setting:  Single-center study.  Subjects:  Sixty patients diagnosed with acute brain injury were randomly assigned to intervention and control groups, equally, and 41 patients completed the study.  Interventions:  All patients were treated by conventional neurologic intensive care. The 23 patients in the intervention group were administered with an integrated WDD in the early stages three times daily; combination treatment was initiated within 14 days and lasted >1 month.  Outcome measures:  Duration of ventilator use, intensive care unit stays, Glasgow Coma Scale (GCS) scores, motor response, the best muscle power, disability rating scale (DRS) scores, modified Rankin scale (mRS) scores, and the mortality rate for the first month. The other outcome measures were GCS scores, motor response, the best muscle power, DRS, mRS, and Barthel index (BI) scores 6 months later.  Results:  There was no mortality in the intervention group, but the rate was 39% in the control group for first month. Comparisons between groups showed significant differences ( p  < 0.05) in GCS, DRS, mRS, and BI scores, indicating improvements in the intervention group after 6 months.  Conclusions:  In the early stages of acute brain injury, combination treatment with WDD was found to be safe. Furthermore, this treatment may improve neurologic functional outcomes after 6 months.",2020,"Comparisons between groups showed significant differences ( p  < 0.05) in GCS, DRS, mRS, and BI scores, indicating improvements in the intervention group after 6 months.  ","['41 patients completed the study', 'Subjects:  Sixty patients diagnosed with acute brain injury', 'Acute Brain Injury', 'All patients were treated by conventional neurologic intensive care', 'patients with acute brain injury as a combination therapy in the early stages']","['Wendan Decoction', 'integrated TCM (Wendan decoction [WDD', 'Traditional Chinese Medicine (TCM) therapy']","['mortality', 'Efficacy and Safety', 'efficacy and safety', 'GCS scores, motor response, the best muscle power, DRS, mRS, and Barthel index (BI) scores', 'Outcome measures:  Duration of ventilator use, intensive care unit stays, Glasgow Coma Scale (GCS) scores, motor response, the best muscle power, disability rating scale (DRS) scores, modified Rankin scale (mRS) scores, and the mortality rate for the first month', 'neurologic functional outcomes', 'GCS, DRS, mRS, and BI scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0085742', 'cui_str': 'Injuries, Acute Brain'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0085559'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}]","[{'cui': 'C2353275', 'cui_str': 'wen-dan decoction'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1285623', 'cui_str': 'Motor response'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C4305168', 'cui_str': 'DRS (Disability Rating Scale) score'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",60.0,0.042874,"Comparisons between groups showed significant differences ( p  < 0.05) in GCS, DRS, mRS, and BI scores, indicating improvements in the intervention group after 6 months.  ","[{'ForeName': 'Chung-Chun', 'Initials': 'CC', 'LastName': 'Huang', 'Affiliation': 'Department of Chinese Medicine, Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taichung, Taiwan.'}, {'ForeName': 'Pei-Yeh', 'Initials': 'PY', 'LastName': 'Chiang', 'Affiliation': 'Department of Neurosurgery, Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taichung, Taiwan.'}, {'ForeName': 'Yu-Chen', 'Initials': 'YC', 'LastName': 'Cheng', 'Affiliation': 'Department of Chinese Medicine, Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taichung, Taiwan.'}, {'ForeName': 'Bor-Ren', 'Initials': 'BR', 'LastName': 'Huang', 'Affiliation': 'Department of Neurosurgery, Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taichung, Taiwan.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0349']
923,31314661,A Randomized Clinical Trial Comparing the Impact of a Web-Based Multimedia Intervention Versus an Educational Pamphlet on Patient Outcomes in Breast Cancer Survivors with Chronic Secondary Lymphedema.,"Objective:  The purpose of this study was to evaluate the effects of a Web-based Multimedia Intervention (WBMI) for breast cancer-related lymphedema (BCRL) patients on symptom burden, function, psychological well-being, costs, and arm volume.  Methods:  Women with BCRL were randomized to intervention ( n  = 80) or control ( n  = 80) groups. The WBMI offered 12 modules, each of which took about 30 minutes to complete. The Pamphlet took about 2 hours to read. Data on symptom burden, psychological well-being, function, and costs were collected preintervention; and 1, 3, 6, and 12 months postintervention. A subgroup of 45 regional patients had arm extracellular fluid measured by bioimpedance at baseline and at 3, 6, and 12 months postintervention. Intervention perceived value was also captured.  Results:  A statistically significant difference ( p  = 0.011) was observed for rates of intervention completion, WBMI (58%), and Pamphlet (77%). With the exception of the number of biobehavioral symptoms (mood), no statistically significant differences between groups in symptom reduction were apparent between baseline and 1 or 12 months (effect sizes = 0.05-0.28,  p  > 0.05) based on the Lymphedema Symptom Intensity and Distress Scale-Arm (LSIDS-A). No statistically significant differences between the groups were observed for changes in other variables. The WBMI was perceived as providing better self-care information than the Pamphlet ( p  = 0.001).  Conclusions:  WBMI participants experienced improved biobehavioral symptoms and higher perceived quality of information. The lack of significant differences on other variables may be due to the high percentage of participants who did not complete the WBMI.",2020,The WBMI was perceived as providing better self-care information than the Pamphlet ( p  = 0.001).  ,"['breast cancer-related lymphedema (BCRL) patients on', 'Women with BCRL', 'Breast Cancer Survivors with Chronic Secondary Lymphedema']","['Web-Based Multimedia Intervention', 'Web-based Multimedia Intervention (WBMI', 'Educational Pamphlet']","['number of biobehavioral symptoms (mood', 'Lymphedema Symptom Intensity and Distress Scale-Arm (LSIDS-A', 'symptom reduction', 'WBMI', 'biobehavioral symptoms and higher perceived quality of information', 'symptom burden, psychological well-being, function, and costs', 'rates of intervention completion, WBMI', 'symptom burden, function, psychological well-being, costs, and arm volume']","[{'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0265191', 'cui_str': 'Chronic acquired lymphedema (disorder)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0222045'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",12.0,0.107559,The WBMI was perceived as providing better self-care information than the Pamphlet ( p  = 0.001).  ,"[{'ForeName': 'Sheila H', 'Initials': 'SH', 'LastName': 'Ridner', 'Affiliation': 'Center for Research Development and Scholarship, School of Nursing, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Mary S', 'Initials': 'MS', 'LastName': 'Dietrich', 'Affiliation': 'Center for Research Development and Scholarship, School of Nursing, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Davis', 'Affiliation': 'Center for Research Development and Scholarship, School of Nursing, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Vaughn', 'Initials': 'V', 'LastName': 'Sinclair', 'Affiliation': 'Center for Research Development and Scholarship, School of Nursing, Vanderbilt University, Nashville, Tennessee.'}]",Journal of women's health (2002),['10.1089/jwh.2019.7676']
924,31307948,"Efficacy and safety of dolutegravir-rilpivirine for maintenance of virological suppression in adults with HIV-1: 100-week data from the randomised, open-label, phase 3 SWORD-1 and SWORD-2 studies.","BACKGROUND


Primary analyses of the SWORD-1 and SWORD-2 trials at 48 weeks showed that switching to a two-drug regimen of dolutegravir plus rilpivirine was non-inferior to continuing a standard three-drug or four-drug antiretroviral regimen for maintenance of virological suppression in people with HIV-1. Here, we present efficacy and safety data from the 100-week analysis of the trials.
METHODS


SWORD-1 and SWORD-2 are identically designed, randomised, open-label phase 3 studies at 65 centres in 13 countries and 60 centres in 11 countries, respectively. Adults aged 18 years or older who were on a standard three-drug or four-drug antiretroviral therapy (ART) and had had fewer than 50 HIV-1 RNA copies per mL of plasma for at least 6 months were randomly assigned (1:1) to 50 mg dolutegravir plus 25 mg rilpivirine orally once daily (early-switch group) or to continue their standard regimen for 52 weeks before switching to the dolutegravir plus rilpivirine combination (ie, the late-switch group). In this analysis of week 100 data, the efficacy endpoint of interest was the proportion of participants with fewer than 50 copies of HIV-1 RNA per mL of plasma (per the US Food and Drug Administration snapshot algorithm). This outcome was assessed in all randomly assigned participants who received at least one dose of the study drug. Data were analysed after the last participant completed week 100 (Sept 15, 2017) and verified through the data cutoff (Nov 21, 2017). SWORD-1 and SWORD-2 are registered with ClinicalTrials.gov, numbers NCT02429791 and NCT02422797, respectively.
FINDINGS


513 participants were randomly assigned to dolutegravir plus rilpivirine (ie, the early-switch group) and 511 to continue their standard ART regimen, 477 of whom then switched to dolutegravir plus rilpivirine at week 52 (ie, the late-switch group). At week 100, 456 (89% [95% CI 86-92]) of 513 participants in the early-switch group and 444 (93% [91-95]) of 477 in the late-switch group had fewer than 50 HIV-1 RNA copies per mL. Drug-related adverse events occurred in 103 (20%) participants in the early-switch group and 58 (12%) in the late-switch group. The most common drug-related adverse events were headache (11 participants in the early-switch group [2%] vs eight [2%] in the late-switch group) and nausea (eight [2%] vs five [1%]).
INTERPRETATION


The combination of dolutegravir plus rilpivirine sustained virological suppression of HIV-1, was associated with a low frequency of virological failure, and had a favourable safety profile, which support its use as a nucleoside reverse transcriptase inhibitor-sparing and protease inhibitor-sparing alternative to three-drug regimens that reduces overall exposure to ART.
FUNDING


ViiV Healthcare and Janssen Pharmaceutica.",2019,RNA copies per mL. Drug-related adverse events occurred in 103 (20%) participants in the early-switch group and 58 (12%) in the late-switch group.,"['65 centres in 13 countries and 60 centres in 11 countries, respectively', '513 participants', 'people with HIV-1', 'adults with HIV-1', 'Adults aged 18 years or older who were on a standard three-drug or four-drug antiretroviral therapy (ART) and had had fewer than 50 HIV-1']","['dolutegravir-rilpivirine', 'rilpivirine combination', 'dolutegravir plus 25 mg rilpivirine', 'dolutegravir plus rilpivirine']","['headache', 'nausea', 'RNA copies per mL. Drug-related adverse events']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C1566826', 'cui_str': 'Rilpivirine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",513.0,0.24491,RNA copies per mL. Drug-related adverse events occurred in 103 (20%) participants in the early-switch group and 58 (12%) in the late-switch group.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Aboud', 'Affiliation': 'ViiV Healthcare, Brentford, UK.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Orkin', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Podzamczer', 'Affiliation': ""IDIBELL-Hospital Universitari de Bellvitge, L'Hospitalet, Barcelona, Spain.""}, {'ForeName': 'Johannes R', 'Initials': 'JR', 'LastName': 'Bogner', 'Affiliation': 'Hospital of the University of Munich, Munich, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baker', 'Affiliation': 'East Sydney Doctors, Darlinghurst, Sydney, NSW, Australia.'}, {'ForeName': 'Marie-Aude', 'Initials': 'MA', 'LastName': 'Khuong-Josses', 'Affiliation': 'CHG-Hôpital Delafontaine, Saint Denis, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Parks', 'Affiliation': 'Central West Clinical Research, St Louis, MO, USA.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Angelis', 'Affiliation': 'GlaxoSmithKline, Uxbridge, UK.'}, {'ForeName': 'Lesley P', 'Initials': 'LP', 'LastName': 'Kahl', 'Affiliation': 'ViiV Healthcare, Brentford, UK. Electronic address: lesley.p.kahl@viivhealthcare.com.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Blair', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Adkison', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Matthews', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Wynne', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Vandermeulen', 'Affiliation': 'Janssen Pharmaceutica, Beerse, Belgium.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gartland', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(19)30149-3']
925,32409760,Comparison of Centella with Flavonoids for Treatment of Symptoms in Hemorrhoidal Disease and After Surgical Intervention: A Randomized Clinical Trial.,"Phlebotonics' effects were evaluated to reduce time-to-stop bleeding and anal irritation in 130 patients who complained of hemorrhoidal disease (HD); bleeding and pain after hemorrhoidectomy (31 patients) and hemorrhoidal thrombosis (34 patients) in the short time. Sixty patients were randomized to receive the routine treatment (both conservative and surgical) (control Group C). The treated group (both conservative and surgical) was divided into two subgroups: one treated with flavonoids (Group A, n = 73), the other with Centella (Group B, n = 66). Time-to-stop bleeding was checked at baseline and checkups (0 up to day 42). Healing was estimated with Kaplan-Meier method, the Kruskal-Wallis test estimated changes in the VAS scores. The HD median time-to-stop bleeding was 2 weeks for Groups A and B; 3 weeks for Group C. VAS scores comparison among Groups (irritation): A vs C, p = 0.007; B vs C, p = 0.041; and A vs B, p = 0.782 resulted respectively. As for operated hemorrhoids, the time-to-stop bleeding was 3 and 4 weeks in Groups A and B and 5 in Group C. Histopathology showed an association between flavonoids and piles' fibrosis (p = 0.008). Phlebotonics in HD, as well as after surgery, showed significant beneficial effects. Flavonoids are the most effective phlebotonics against bleeding and anal irritation.",2020,Phlebotonics' effects were evaluated to reduce time-to-stop bleeding and anal irritation in 130 patients who complained of hemorrhoidal disease (HD); bleeding and pain after hemorrhoidectomy (31 patients) and hemorrhoidal thrombosis (34 patients) in the short time.,"['Hemorrhoidal Disease and After Surgical Intervention', 'Groups (irritation', 'Sixty patients', '130 patients who complained of hemorrhoidal disease (HD); bleeding and pain after hemorrhoidectomy (31 patients) and hemorrhoidal thrombosis (34 patients) in the short time']","['routine treatment (both conservative and surgical) (control Group C', 'Flavonoids', 'Centella with Flavonoids', 'flavonoids']","['time-to-stop bleeding', 'Time-to-stop bleeding', 'HD median time-to-stop bleeding', 'time-to-stop bleeding and anal irritation', 'Healing', 'VAS scores']","[{'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0596577', 'cui_str': 'Flavonoid'}, {'cui': 'C0936041', 'cui_str': 'Hydrocotyle'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1735348', 'cui_str': 'Anal irritation'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",130.0,0.0194777,Phlebotonics' effects were evaluated to reduce time-to-stop bleeding and anal irritation in 130 patients who complained of hemorrhoidal disease (HD); bleeding and pain after hemorrhoidectomy (31 patients) and hemorrhoidal thrombosis (34 patients) in the short time.,"[{'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Chiaretti', 'Affiliation': 'Department of General Surgery and Specialties ""Paride Stefanini"", Sapienza University of Rome, Rome, 00161, Italy. massimo.chiaretti@uniroma1.it.'}, {'ForeName': 'Danilo Alunni', 'Initials': 'DA', 'LastName': 'Fegatelli', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, 00161, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pappalardo', 'Affiliation': 'Department of General Surgery and Specialties ""Paride Stefanini"", Sapienza University of Rome, Rome, 00161, Italy.'}, {'ForeName': 'Michele Dello Spedale', 'Initials': 'MDS', 'LastName': 'Venti', 'Affiliation': 'Department of Molecular Medicine, Sapienza University of Rome, Rome, 00161, Italy.'}, {'ForeName': 'Annalisa Italia', 'Initials': 'AI', 'LastName': 'Chiaretti', 'Affiliation': 'Department of General Surgery and Specialties ""Paride Stefanini"", Sapienza University of Rome, Rome, 00161, Italy.'}]",Scientific reports,['10.1038/s41598-020-64772-0']
926,31034594,Older Adults with Cancer: A Randomized Controlled Trial of Occupational and Physical Therapy.,"OBJECTIVES


The impact of occupational therapy (OT) and physical therapy (PT) on functional outcomes in older adults with cancer is unknown.
DESIGN


Two-arm single-institution randomized controlled trial of outpatient OT/PT.
SETTING


Comprehensive cancer center with two off-site OT/PT clinics.
PARTICIPANTS


We recruited adults 65 years and older with a recent diagnosis or recurrence of cancer within 5 years, with at least one functional limitation as identified by a geriatric assessment. Participants were randomized to OT/PT or usual care.
INTERVENTION


Rehabilitation consisted of individualized OT and PT that addressed functional activities and strength/endurance needs.
MEASUREMENTS


Primary outcome was functional status as measured by the Nottingham Extended Activities of Daily Living scale. Secondary outcomes were Patient-Reported Outcomes Measurement Information System-Global Mental Health (GMH) and Global Physical Health (GPH), ability to participate in Social Roles (SR), physical function, and activity expectations and self-efficacy (Possibilities for Activity Scale [PActS]).
RESULTS


Among those recruited (N = 63), only 45 patients (71%) were evaluable due to loss of follow-up and/or nonreceipt of intervention. The median age was 74 years; 53% were female, and 91% were white. Overall, 30% patients had hematologic malignancies, 30% breast cancer, and 16% colorectal cancers. A total of 65% were in active treatment; 49% had stage 3 or 4 disease. At follow-up, both OT/PT (P = .02) and usual care (P = .03) groups experienced a decline in functional status. PActS scores between groups (P = .04) was significantly improved in the intervention group. GMH and SR met criteria for minimally important clinical difference favoring the intervention, but not statistical significance. Several barriers were noted in the implementation of the intervention program: recruitment, concerns about cost, distance, scheduling, and limited treatment provided.
CONCLUSION


OT/PT may positively influence activity expectations and self-efficacy. Future research needs to address significant barriers to implementation to increase use of OT/PT services and access to quality care. J Am Geriatr Soc 67:953-960, 2019.",2019,"At follow-up, both OT/PT (P = .02) and usual care (P = .03) groups experienced a decline in functional status.","['Older Adults with Cancer', 'The median age was 74\u2009years; 53% were female, and 91% were white', 'older adults with cancer', 'Comprehensive cancer center with two off-site OT/PT clinics', 'We recruited adults 65\u2009years and older with a recent diagnosis or recurrence of cancer within 5\u2009years, with at least one functional limitation as identified by a geriatric assessment']","['occupational therapy (OT) and physical therapy (PT', 'OT/PT or usual care', 'Occupational and Physical Therapy', 'Rehabilitation consisted of individualized OT and PT that addressed functional activities and strength/endurance needs']","['Information System-Global Mental Health (GMH) and Global Physical Health (GPH), ability to participate in Social Roles (SR), physical function, and activity expectations and self-efficacy', 'activity expectations and self-efficacy', 'functional status as measured by the Nottingham Extended Activities of Daily Living scale', 'PActS scores', 'hematologic malignancies', 'functional status']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0017463', 'cui_str': 'Geriatric Assessment'}]","[{'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C0021428', 'cui_str': 'Information Systems'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451151', 'cui_str': 'Extended activities of daily living scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}]",65.0,0.037498,"At follow-up, both OT/PT (P = .02) and usual care (P = .03) groups experienced a decline in functional status.","[{'ForeName': 'Mackenzi', 'Initials': 'M', 'LastName': 'Pergolotti', 'Affiliation': 'Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Deal', 'Affiliation': 'Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Grant R', 'Initials': 'GR', 'LastName': 'Williams', 'Affiliation': 'Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Ashley L', 'Initials': 'AL', 'LastName': 'Bryant', 'Affiliation': 'Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'McCarthy', 'Affiliation': 'Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Kirsten A', 'Initials': 'KA', 'LastName': 'Nyrop', 'Affiliation': 'Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Kelley R', 'Initials': 'KR', 'LastName': 'Covington', 'Affiliation': 'Department of Occupational Therapy, Colorado State University, Fort Collins, Colorado.'}, {'ForeName': 'Bryce B', 'Initials': 'BB', 'LastName': 'Reeve', 'Affiliation': 'Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Basch', 'Affiliation': 'Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Hyman B', 'Initials': 'HB', 'LastName': 'Muss', 'Affiliation': 'Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.15930']
927,32208397,Safety and Efficacy of Prasugrel in Elderly/Low Body Weight Japanese Patients with Ischemic Stroke: Randomized PRASTRO-II.,"INTRODUCTION


The safety of prasugrel in elderly and/or low body weight Japanese patients with ischemic stroke who have a relatively high bleeding risk with antiplatelet therapy remains unknown.
OBJECTIVE


We aimed to investigate the safety and efficacy of long-term prasugrel monotherapy for stroke prevention compared with clopidogrel in elderly and/or low body weight Japanese patients with non-cardioembolic ischemic stroke.
METHODS


In this randomized, double-blind, comparative, phase III study, elderly (age ≥75 years) and/or low body weight (≤50 kg) Japanese patients with a previous history of non-cardioembolic ischemic stroke were assigned to a prasugrel 3.75 mg (PRA3.75) group, a prasugrel 2.5 mg (PRA2.5) group, or a clopidogrel 50 mg (CLO50) group and followed up for 48 weeks. The primary safety endpoint was the combined incidence of primary safety events, defined as life-threatening, major, and other clinically relevant bleeding. The efficacy endpoint was a composite of ischemic stroke, myocardial infarction, and death from other vascular causes.
RESULTS


A total of 654 patients (age 76.4 ± 7.3 years, body weight 55.6 ± 9.3 kg, women 43.9%) from 74 medical institutions within Japan were enrolled. The combined incidence (95% CI) of primary safety events was 4.2% (1.9-7.8%), 1.9% (0.5-4.7%), and 3.6% (1.6-6.9%) in the PRA3.75 group (n = 216), PRA2.5 group (n = 215), and CLO50 group (n = 223), respectively (hazard ratios [HR] PRA3.75/CLO50, 1.13 [0.44-2.93]; PRA2.5/CLO50, 0.51 [0.15-1.69]). The incidences of bleeding leading to treatment discontinuation (95% CI) were 2.3% (0.8-5.3%), 0.9% (0.1-3.3%), and 2.2% (0.7-5.2%) in the PRA3.75, PRA2.5, and CLO50 groups, respectively (HRs PRA3.75/CLO50, 1.01 [0.29-3.48]; PRA2.5/CLO50, 0.41 [0.08-2.12]). There was no significant difference in all bleeding events between groups. The incidence of ischemic stroke, myocardial infarction, and death from other vascular causes was lower, but not significantly so, in patients treated with prasugrel than in patients treated with clopidogrel: PRA3.75, 0.0% (0/216); PRA2.5, 3.3% (7/215); and CLO50, 3.6% (8/223; HRs PRA3.75/CLO50, 0.00 [0.00-0.00]; PRA2.5/CLO50, 0.90 [0.32-2.47]).
CONCLUSIONS


Elderly and/or low body weight -Japanese patients with previous non-cardioembolic ischemic stroke who received PRA3.75 showed similar results in terms of primary safety endpoint, and a numerically lower incidence of ischemic stroke, myocardial infarction, and death from other vascular causes, compared with those who received CLO50.",2020,"The incidence of ischemic stroke, myocardial infarction, and death from other vascular causes was lower, but not significantly so, in patients treated with prasugrel than in patients treated with clopidogrel: PRA3.75, 0.0% (0/216); PRA2.5, 3.3% (7/215); and CLO50, 3.6% (8/223; HRs PRA3.75/CLO50, 0.00 [0.00-0.00]; PRA2.5/CLO50, 0.90 [0.32-2.47]).
","['Elderly/Low Body Weight Japanese Patients with Ischemic Stroke', '654 patients (age 76.4 ± 7.3 years, body weight 55.6 ± 9.3 kg, women 43.9%) from 74 medical institutions within Japan were enrolled', 'elderly and/or low body weight Japanese patients with non-cardioembolic ischemic stroke', 'elderly and/or low body weight Japanese patients with ischemic stroke who have a relatively high bleeding risk with antiplatelet therapy remains unknown', 'elderly (age ≥75 years) and/or low body weight (≤50 kg) Japanese patients with a previous history of non-cardioembolic ischemic stroke']","['clopidogrel', 'Prasugrel', 'prasugrel 3.75 mg (PRA3.75', 'clopidogrel 50 mg (CLO50', 'PRA3.75', 'prasugrel 2.5\xa0mg (PRA2.5', 'long-term prasugrel monotherapy', 'prasugrel']","['combined incidence of primary safety events, defined as life-threatening, major, and other clinically relevant bleeding', 'Safety and Efficacy', 'composite of ischemic stroke, myocardial infarction, and death from other vascular causes', 'bleeding events', 'incidences of bleeding leading to treatment discontinuation', 'incidence of ischemic stroke, myocardial infarction, and death from other vascular causes', 'ischemic stroke, myocardial infarction, and death', 'safety and efficacy']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C4517697', 'cui_str': 'Three point seven five'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",654.0,0.052672,"The incidence of ischemic stroke, myocardial infarction, and death from other vascular causes was lower, but not significantly so, in patients treated with prasugrel than in patients treated with clopidogrel: PRA3.75, 0.0% (0/216); PRA2.5, 3.3% (7/215); and CLO50, 3.6% (8/223; HRs PRA3.75/CLO50, 0.00 [0.00-0.00]; PRA2.5/CLO50, 0.90 [0.32-2.47]).
","[{'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kitagawa', 'Affiliation': ""Department of Neurology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan, kitagawa.kazuo@twmu.ac.jp.""}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Takanari', 'Initials': 'T', 'LastName': 'Kitazono', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Masakatsu', 'Initials': 'M', 'LastName': 'Nishikawa', 'Affiliation': 'Clinical Research Support Center, Mie University Hospital, Mie, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Nanto', 'Affiliation': 'Department of Cardiology, Nishinomiya Municipal Central Hospital, Hyogo, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ikeda', 'Affiliation': 'Waseda University Faculty of Science and Engineering, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Abe', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Ogawa', 'Affiliation': 'Department of Neurosurgery, Iwate Medical University, Iwate, Japan.'}]","Cerebrovascular diseases (Basel, Switzerland)",['10.1159/000506825']
928,31133624,Lifestyle Interventions to Promote Healthy Nutrition and Physical Activity in Middle-Age (40-60 Years) Adults: A Randomized Controlled Trial in the North of Iran.,"BACKGROUND


This study was conducted to evaluate the effectiveness of short-term structured interventions on healthy lifestyle behaviors, dietary intake, anthropometric measures, blood pressure, fasting blood glucose, and serum lipid profile of middle-aged adults.
STUDY DESIGN


Randomized controlled trial study.
METHODS


Overall, 300 individuals out of apparently healthy (non-patient) adults aged 40-60 yr living in Amirkola, Babol the north of Iran were enrolled in 2016-2017. The Persian translation of the Health Promoting Lifestyle Profile II (HPLP-II) and two days 24-h food recall questionnaires were used for data collection. Eligible participants were allocated randomly in three groups (high-intensive, low-intensive and the control). The follow-up examination has been conducted after 16 wk of intervention.
RESULTS


The three study groups had no significant difference in age (P=0.888), sex (P=0.395), BMI (P=0.969), healthy lifestyle score (P=0.675) and total daily energy intake (P=0.612). After intervention, the mean scores of all the six subdomains of HPLP-II questionnaire had significant improvement (P<0.001). Mean weight loss was 1.5, 1.0 and 0.3 kg, in high-intensive, low-intensive and control groups, respectively. BMI although reduced, was still in the overweight range in two sexes. Mean of neck, arm, waist and buttock size, diastolic blood pressure, serum triglyceride, total cholesterol, and HDL levels have been changed to a better condition in comparison with the baseline values (P<0.001). Dietary intake had good changes in total daily energy (P<0.001), daily intake of carbohydrate, protein, and fat (P<0.001), and proportion of energy from carbohydrate (P=0.007) and fat (P=0.022) after the intervention.
CONCLUSION


Our intervention program could have positive impact on healthy lifestyle behaviors, dietary intake and weight in addition to some other anthropometric variables and serum lipid profile of middle-aged adults.",2019,"Dietary intake had good changes in total daily energy (P<0.001), daily intake of carbohydrate, protein, and fat (P<0.001), and proportion of energy from carbohydrate (P=0.007) and fat (P=0.022) after the intervention.
","['Adults', '40-60 Years', '300 individuals out of apparently healthy (non-patient) adults aged 40-60 yr living in Amirkola, Babol the north of Iran were enrolled in 2016-2017', 'Eligible participants', 'North of Iran', 'Middle-Age', 'middle-aged adults']","['Lifestyle Interventions to Promote Healthy Nutrition and Physical Activity', 'short-term structured interventions']","['BMI', 'total daily energy (P<0.001), daily intake of carbohydrate, protein, and fat (P<0.001), and proportion of energy from carbohydrate', 'Mean weight loss', 'healthy lifestyle behaviors, dietary intake, anthropometric measures, blood pressure, fasting blood glucose, and serum lipid profile', 'Mean of neck, arm, waist and buttock size, diastolic blood pressure, serum triglyceride, total cholesterol, and HDL levels', 'total daily energy intake', 'healthy lifestyle score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0026062', 'cui_str': 'Middle Age'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0006497', 'cui_str': 'Buttocks'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0380534,"Dietary intake had good changes in total daily energy (P<0.001), daily intake of carbohydrate, protein, and fat (P<0.001), and proportion of energy from carbohydrate (P=0.007) and fat (P=0.022) after the intervention.
","[{'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Mouodi', 'Affiliation': 'Social Determinants of Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Hosseini', 'Affiliation': 'Social Determinants of Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. hosseinirezaseyed@gmail.com.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Ghadimi', 'Affiliation': 'Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Robert Graham', 'Initials': 'RG', 'LastName': 'Cumming', 'Affiliation': 'School of Public Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Bijani', 'Affiliation': 'Social Determinants of Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Mouodi', 'Affiliation': 'Department of Internal Medicine, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Yadollah', 'Initials': 'Y', 'LastName': 'Zahed Pasha', 'Affiliation': 'Non-communicable Pediatric Diseases Research Center, Babol University of Medical Sciences, Babol, Iran.'}]",Journal of research in health sciences,[]
929,32027446,Once-Daily Oxycodone Prolonged-Release Tablets Are Resistant to Alcohol-Induced Dose Dumping: Results From a Randomized Trial in Healthy Volunteers.,"The objective of this study was to determine the effect of concomitant alcohol intake on the bioavailability of oxycodone from an oxycodone once-daily (OOD) formulation and an oxycodone twice-daily (OTD) formulation. A phase I, open-label, randomized, crossover alcohol interaction study in 20 healthy volunteers under fasting conditions was conducted. Participants received five treatments, OOD with 240 mL of 0%, 20%, or 40% alcohol; and OTD with 240 mL of 0% or 40% alcohol. Pharmacokinetic parameters did not differ between participants taking OOD with water or with 240 mL of 20% alcohol. There was a slight increase in overall oxycodone absorption from OOD with 40% alcohol but no increase in peak absorption. Oxycodone absorption from OTD showed peak and overall increases with 40% alcohol but maintained a prolonged-release profile. Although it is recommended that alcohol be avoided while taking opioids, there was no evidence of alcohol-induced dose dumping in these oxycodone formulations.",2020,Oxycodone absorption from OTD showed peak and overall increases with 40% alcohol but maintained a prolonged-release profile.,"['20 healthy volunteers under fasting conditions was conducted', 'healthy volunteers']","['oxycodone twice-daily (OTD) formulation', 'OOD with 240 mL of 0, 20, or 40% alcohol; and OTD with 240 mL of 0 or 40% alcohol']","['Pharmacokinetic parameters', 'peak absorption', 'overall oxycodone absorption', 'bioavailability of oxycodone']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}]",20.0,0.028047,Oxycodone absorption from OTD showed peak and overall increases with 40% alcohol but maintained a prolonged-release profile.,"[{'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Burger', 'Affiliation': 'Develco Pharma Schweiz AG, Pratteln, Switzerland.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Fraser', 'Affiliation': 'Develco Pharma Schweiz AG, Pratteln, Switzerland.'}, {'ForeName': 'Martina Alice', 'Initials': 'MA', 'LastName': 'Maritz', 'Affiliation': 'Develco Pharma Schweiz AG, Pratteln, Switzerland.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Faulkner', 'Affiliation': 'BioPharma Services Inc., Toronto, Ontario, Canada.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Rey', 'Affiliation': 'Develco Pharma Schweiz AG, Pratteln, Switzerland.'}]",Clinical and translational science,['10.1111/cts.12737']
930,31311018,A Clinical Significance of Intermittent Infusion Hemodiafiltration Using Backfiltration of Ultrapure Dialysis Fluid Compared to Hemodialysis: A Multicenter Randomized Controlled Crossover Trial.,"BACKGROUND


Intermittent infusion hemodiafiltration -(I-HDF) using repeated infusion of ultrapure dialysis fluid through a dialysis membrane or sterile nonpyrogenic substitution fluid was developed to prevent a rapid decrease in blood pressure by increasing the patient's circulating blood volume, to enhance the plasma refilling rate by improving peripheral circulation, and to enhance solute transfer from the extravascular space to the intravascular space by enhancing the plasma refilling rate. Furthermore, the effect of fouling caused by attachment of proteins to the membrane as a result of ultrafiltration can be reduced by backflushing of the membrane with the purified dialysate in I-HDF. Although there have been several clinical trials of I-HDF, there have been no comparisons of the clinical significance of and indications for -I-HDF with those of conventional hemodialysis (HD).
OBJECTIVE


The aim of this multicenter randomized controlled crossover trial was to compare the clinical significance of -I-HDF with that of HD in Japan.
METHOD


Patients were randomized to receive HD, I-HDF, and HD (group A) or I-HDF, HD, and I-HDF (group B) in that order for 14 weeks each. The sample size of 70 was determined based on the operability and patient availability. Treatment outcomes were evaluated 5 and 14 weeks after the start of each treatment period. The patients received 4-h treatment sessions with no changes in session duration or anticoagulant therapy during the study. I-HDF was performed using a GC-110N dialysis machine. Two hundred milliliters of ultrapure dialysis fluid were infused at a rate of 150 mL/min by backfiltration every 30 min during treatment. The first and last infusions were performed 30 min after the start and 30 min before the end of treatment, respectively. The total estimated infusion volume per session was 1.4 L (i.e., 200 mL × 7 infusions). I-HDF is a type of online HDF with a small fluid replacement volume. An ABH-P polysulfone membrane hemodiafilter was used for -I-HDF and a class 1 or 2 hemodialyzer with a polysulfone membrane not coated with vitamin E and approved by the Japanese reimbursement system was used for HD. The primary outcomes were the Short Form-36 version 2 summary scores for quality of life and the visual analog scale scores for clinical symptoms. Secondary outcomes were vital signs, number of interventions, and pre-treatment blood test results. These variables were evaluated 1 week before at the start of the study, and at 5 and 14 weeks after the start of each treatment period. The removal characteristics of the various solutes were evaluated when possible on the first day of each treatment period. All patients provided written informed consent to participate.
RESULTS


Thirty-two patients in group A and 32 patients in group B completed the trial. There were no differences in the primary or secondary outcomes between I-HDF and HD. Serum α1-microglobulin (MG) levels at 14 weeks were significantly lower for I-HDF than for HD. During treatment, the removal rates for urea and creatinine, which are low molecular weight substances, were significantly lower during I-HDF than during HD. In contrast, the β2-MG and α1-MG removal rates were significantly higher during I-HDF than during HD. Furthermore, there was significantly less albumin leak during I-HDF than during HD. The solute removal results reflect the difference in pore size between the hemodiafilter used for I-HDF and the hemodialyzer used for HD and the difference in convective transport attributable to filtration between the 2 methods.
CONCLUSIONS


These findings show that the removal rates of low molecular weight substances are significantly lower and those of medium to high molecular weight substances are significantly higher with I-HDF than with HD. They also indicate that there is significantly less albumin leak during I-HDF than during HD, meaning that I-HDF may be a particularly suitable dialysis modality for patients with malnutrition and the elderly in Japan.",2019,Serum α1-microglobulin (MG) levels at 14 weeks were significantly lower for I-HDF than for HD.,"['Japan', 'Hemodialysis', 'Patients', 'patients with malnutrition and the elderly in Japan']","['GC-110N dialysis machine', 'HD, I-HDF, and HD (group A) or I-HDF, HD, and I-HDF', '4-h treatment sessions with no changes in session duration or anticoagulant therapy', 'ABH-P polysulfone membrane hemodiafilter']","['Short Form-36 version 2 summary scores for quality of life and the visual analog scale scores for clinical symptoms', 'albumin leak', 'vital signs, number of interventions, and pre-treatment blood test results', 'Serum α1-microglobulin (MG) levels', 'removal rates for urea and creatinine', 'blood pressure', 'removal rates of low molecular weight substances', 'β2-MG and α1-MG removal rates']","[{'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy (procedure)'}, {'cui': 'C0137909', 'cui_str': 'polysulfone'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0332234', 'cui_str': 'Leaking (qualifier value)'}, {'cui': 'C0518766'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}]",200.0,0.0368732,Serum α1-microglobulin (MG) levels at 14 weeks were significantly lower for I-HDF than for HD.,"[{'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Mineshima', 'Affiliation': ""Department of Clinical Engineering, Tokyo Women's Medical University, Tokyo, Japan, mmine@twmu.ac.jp.""}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'International Kidney Evaluation Association Japan, Tokyo, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Tomo', 'Affiliation': 'Clinical Engineering Research Center, Oita University, Oita, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Kawanishi', 'Affiliation': 'Tsuchiya General Hospital, Hiroshima, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kawaguchi', 'Affiliation': 'Joban Hospital, Fukushima, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Minakuchi', 'Affiliation': 'Kawashima Hospital, Tokushima, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nakanishi', 'Affiliation': 'Division of Kidney and Dialysis, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Meiko Kyoritsu Clinic, Nagoya, Japan.'}, {'ForeName': 'Kosaku', 'Initials': 'K', 'LastName': 'Nitta', 'Affiliation': ""Department of Clinical Engineering, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Tsuchiya', 'Affiliation': ""Department of Clinical Engineering, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Ikuto', 'Initials': 'I', 'LastName': 'Masakane', 'Affiliation': 'Yabuki Hospital, Yamagata, Japan.'}, {'ForeName': 'Noritomo', 'Initials': 'N', 'LastName': 'Itami', 'Affiliation': 'Itami Kidney Clinic, Noboribetsu, Japan.'}]",Blood purification,['10.1159/000501511']
931,17469886,Personalized mailed feedback for college drinking prevention: a randomized clinical trial.,"The current study was designed to evaluate the efficacy of a mailed feedback and tips intervention as a universal prevention strategy for college drinking. Participants (N = 1,488) were randomly assigned to feedback or assessment-only control conditions. Results indicated that the mailed feedback intervention had a preventive effect on drinking rates overall, with participants in the feedback condition consuming less alcohol at follow-up in comparison with controls. In addition, abstainers in the feedback condition were twice as likely to remain abstinent from alcohol at follow-up in comparison with control participants (odds ratio = 2.02), and feedback participants were significantly more likely to refrain from heavy episodic drinking (odds ratio = 1.43). Neither gender nor severity of baseline drinking moderated the efficacy of the intervention in these analyses, but more conservative analyses utilizing last-observation carryforward suggested women and abstainers benefited more from this prevention approach. Protective behaviors mediated intervention efficacy, with participants who received the intervention being more likely to use strategies such as setting limits and alternating alcohol with nonalcoholic beverages. Implications of these findings for universal prevention of college drinking are discussed.",2007,"Results indicated that the mailed feedback intervention had a preventive effect on drinking rates overall, with participants in the feedback condition consuming less alcohol at follow-up in comparison with controls.","['college drinking prevention', 'Participants (N = 1,488', 'college drinking']","['feedback or assessment-only control conditions', 'mailed feedback intervention', 'mailed feedback and tips intervention']",[],"[{'cui': 'C4042862', 'cui_str': 'University Student Drinking'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0024492', 'cui_str': 'Mail'}]",[],1488.0,0.0181692,"Results indicated that the mailed feedback intervention had a preventive effect on drinking rates overall, with participants in the feedback condition consuming less alcohol at follow-up in comparison with controls.","[{'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Larimer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA 98105, USA. larimer@u.washington.edu'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Kilmer', 'Affiliation': ''}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Fabiano', 'Affiliation': ''}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Stark', 'Affiliation': ''}, {'ForeName': 'Irene M', 'Initials': 'IM', 'LastName': 'Geisner', 'Affiliation': ''}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Mallett', 'Affiliation': ''}, {'ForeName': 'Ty W', 'Initials': 'TW', 'LastName': 'Lostutter', 'Affiliation': ''}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Cronce', 'Affiliation': ''}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Feeney', 'Affiliation': ''}, {'ForeName': 'Clayton', 'Initials': 'C', 'LastName': 'Neighbors', 'Affiliation': ''}]",Journal of consulting and clinical psychology,[]
932,31299067,An apparent paradox: resistance mutations in HIV-1 DNA predict improved virological responses to antiretroviral therapy.,"BACKGROUND


In sub-Saharan Africa, detecting resistance-associated mutations (RAMs) at failure of first-line ART with two NRTIs plus an NNRTI predicts improved virological responses to second-line therapy with two NRTIs plus a ritonavir-boosted PI (PI/r). This indicates residual NRTI activity in the presence of RAMs, although additional factors may contribute to the effect.
OBJECTIVES


The aim of this study was to investigate the influence of pre-existing RAMs on the outcomes of maintenance monotherapy with ritonavir-boosted darunavir within a randomized trial in Cameroon.
METHODS


RAMs were detected in HIV-1 DNA using PBMCs collected at initiation of darunavir/ritonavir monotherapy. Adherence was assessed by pill count and visual analogue scale (VAS). Predictors of virological failure (confirmed or last available viral load >400 copies/mL) were explored by logistic regression analysis. Trial name = MANET (NCT02155101).
RESULTS


After NNRTI-based therapy, participants (n = 81) had received PI/r-based therapy for a median of 3.2 years and had a confirmed viral load <60 copies/mL and a median CD4 count of 466 cells/mm3. NRTI and NNRTI RAMs were detected in 39/60 (65.0%) and 41/60 (68.3%) HIV-1 DNA sequences, respectively. Over 48 weeks of monotherapy, 16/81 (19.8%) patients experienced virological failure. After adjusting for age, HIV-1 DNA load, adherence by VAS and RAM status, virological failure was less likely with higher VAS-measured adherence (adjusted OR 0.04, 95% CI 0.01-0.37; P = 0.004) and detectable HIV-1 DNA RAMs (adjusted OR 0.15, 95% CI 0.03-0.82; P = 0.028).
CONCLUSIONS


Pre-existing NRTI and NNRTI RAMs are associated with improved virological responses to NRTI-sparing ART in sub-Saharan Africa, indicating a predictive effect that is independent of residual NRTI activity.",2019,"CONCLUSIONS


Pre-existing NRTI and NNRTI RAMs are associated with improved virological responses to NRTI-sparing ART in sub-Saharan Africa, indicating a predictive effect that is independent of residual NRTI activity.","['RAMs were detected in HIV-1 DNA using PBMCs collected at initiation of darunavir/ritonavir monotherapy', 'Cameroon']",['ritonavir-boosted darunavir'],"['detectable HIV-1 DNA RAMs', 'pill count and visual analogue scale (VAS', 'virological responses', 'HIV-1', 'virological failure', 'Adherence', 'NRTI and NNRTI RAMs', 'HIV-1 DNA load, adherence by VAS and RAM status, virological failure']","[{'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0006802', 'cui_str': 'Republic of Cameron'}]","[{'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}]","[{'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",,0.446561,"CONCLUSIONS


Pre-existing NRTI and NNRTI RAMs are associated with improved virological responses to NRTI-sparing ART in sub-Saharan Africa, indicating a predictive effect that is independent of residual NRTI activity.","[{'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Geretti', 'Affiliation': 'Institute of Infection & Global Health, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Abdullahi', 'Affiliation': 'Institute of Infection & Global Health, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Mafotsing Fopoussi', 'Affiliation': 'Institute of Infection & Global Health, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bonnett', 'Affiliation': 'Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Victoire Fokom', 'Initials': 'VF', 'LastName': 'Defo', 'Affiliation': 'Chantal Biya International Reference Centre for Research on HIV/AIDS Prevention & Management (CIRCB), Yaoundé, Cameroon.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Moudourou', 'Affiliation': 'Chantal Biya International Reference Centre for Research on HIV/AIDS Prevention & Management (CIRCB), Yaoundé, Cameroon.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Fokam', 'Affiliation': 'Chantal Biya International Reference Centre for Research on HIV/AIDS Prevention & Management (CIRCB), Yaoundé, Cameroon.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kouanfack', 'Affiliation': 'Hôpital Central Yaoundé, Ministry of Public Health, Yaoundé, Cameroon.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Torimiro', 'Affiliation': 'Chantal Biya International Reference Centre for Research on HIV/AIDS Prevention & Management (CIRCB), Yaoundé, Cameroon.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz264']
933,31303297,"The effect of report cards on the coverage of maternal and neonatal health care: a factorial, cluster-randomised controlled trial in Uttar Pradesh, India.","BACKGROUND


Report cards are a prominent strategy to increase the ability of citizens to express their view, improve public accountability, and foster community participation in the provision of health services in low-income and middle-income countries. In India, social accountability interventions that incorporate report cards and community meetings have been implemented at scale, attracting considerable policy attention, but there is little evidence on their effectiveness in improving health. We aimed to evaluate the effect of report cards, which contain information on village-level indicators of maternal and neonatal health care, and participatory meetings targeted at health providers and community members (including local leaders) on the coverage of maternal and neonatal health care in Uttar Pradesh, India.
METHODS


We conducted a repeated cross-sectional, 2 × 2 factorial, cluster-randomised controlled trial, in which each cluster was a village (rural) or ward (urban). The clusters were randomly assigned to one of four groups: the provider group, in which we shared report cards and held participatory meetings with providers of maternal and neonatal health services; the community group, in which we shared report cards and held participatory meetings with community members (including local leaders); the providers and community group, in which report cards were targeted at both health providers and the community; and the control group, in which report cards were not shared with anyone. We generated these report cards by collating data from household surveys and shared the report cards with the recipients (as determined by their assigned groups) in participatory meetings. The primary outcome was the proportion of women who had at least four antenatal care visits (ie, attended a clinic or were visited at home by a health-care worker) during their last pregnancy. We measured outcomes with cross-sectional household surveys that were taken at baseline, at a first follow-up (after 8 months of the intervention), and at a second follow-up (21 months after the start of the intervention). Analyses were by intention to treat. This trial is registered with ISRCTN, number ISRCTN11070792.
FINDINGS


We surveyed eligible women for the baseline survey between Jan 13, and Feb 5, 2015. We then randomly assigned 44 clusters to the provider group, 45 clusters to the community group, 45 clusters to the provider and community group, and 44 clusters to the control group. Report cards of collated survey data were provided to recipient groups, as per their random allocation, in October, 2015, and in September, 2016. We ran the first follow-up survey between May 16 and June 10, 2016. We ran the second follow-up survey between June 18 and July 18, 2017. We measured the primary outcome in 3133 women (795 in the provider group, 781 in the community group, 798 in the provider and community group, and 759 in the control group) who gave birth during implementation of the intervention, between Feb 1, 2016, and July 18, 2017 (the end of the second follow-up survey). The report card intervention did not significantly affect the proportion of women who had at least four antenatal care visits (provider vs non-provider: odds ratio 0·85, 95% CI 0·65-1·13; community vs non-community: 0·86, 0·65-1·13).
INTERPRETATION


Maternal health report cards containing information on village performance, targeted at either the community or health providers, had no detectable effect on the coverage of maternal and neonatal health care. Future research should seek to understand how the content of information and the delivery of report cards affect the success of this type of social accountability intervention.
FUNDING


Merck Sharp and Dohme.",2019,"The report card intervention did not significantly affect the proportion of women who had at least four antenatal care visits (provider vs non-provider: odds ratio 0·85, 95% CI 0·65-1·13; community vs non-community: 0·86, 0·65-1·13).
","['3133 women (795 in the provider group, 781 in the community group, 798 in the provider and community group, and 759 in the control group) who gave birth during implementation of the intervention, between Feb 1, 2016, and July 18, 2017 (the end of the second follow-up survey', 'repeated cross-sectional, 2\u2008×\u20082 factorial, cluster-randomised controlled trial, in which each cluster was a village (rural) or ward (urban', 'health providers and community members (including local leaders) on the coverage of maternal and neonatal health care in Uttar Pradesh, India', 'surveyed eligible women for the baseline survey between Jan 13, and Feb 5, 2015']","['provider group, in which we shared report cards and held participatory meetings with providers of maternal and neonatal health services; the community group, in which we shared report cards and held participatory meetings with community members (including local leaders); the providers and community group, in which report cards were targeted at both health providers and the community; and the control group, in which report cards were not shared with anyone']","['proportion of women who had at least four antenatal care visits (ie, attended a clinic or were visited at home by a health-care worker']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4042838', 'cui_str': 'Health of Newborn Infants'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4042838', 'cui_str': 'Health of Newborn Infants'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1553387', 'cui_str': 'Hold'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]",3133.0,0.104485,"The report card intervention did not significantly affect the proportion of women who had at least four antenatal care visits (provider vs non-provider: odds ratio 0·85, 95% CI 0·65-1·13; community vs non-community: 0·86, 0·65-1·13).
","[{'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Fabbri', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Dutt', 'Affiliation': 'Sambodhi Research and Communications, Noida, Uttar Pradesh, India.'}, {'ForeName': 'Vasudha', 'Initials': 'V', 'LastName': 'Shukla', 'Affiliation': 'Sambodhi Research and Communications, Noida, Uttar Pradesh, India.'}, {'ForeName': 'Kultar', 'Initials': 'K', 'LastName': 'Singh', 'Affiliation': 'Sambodhi Research and Communications, Noida, Uttar Pradesh, India.'}, {'ForeName': 'Nehal', 'Initials': 'N', 'LastName': 'Shah', 'Affiliation': 'Sambodhi Research and Communications, Noida, Uttar Pradesh, India.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Powell-Jackson', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK. Electronic address: Timothy.Powell-Jackson@lshtm.ac.uk.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30254-2']
934,31287437,Intratympanic Steroid Treatment of Bell's Palsy in Patients with Comorbid Disease: A Preliminary Report.,"OBJECTIVES


This study evaluated the efficacy of intratympanic steroid injection (ITSI)as initial treatment and therecovery speed for Bell's palsy (BP)inpatients with diabetes mellitus (DM)and/or hypertension (HT).
MATERIALS AND METHODS


In total,90 patients with comorbid diseases diagnosed with BP received either ITSI (study group, n=61) or systemic steroid treatment (SST) (control group, n=29).The facial nerve function was assessed using the House-Brackmann (HB) grading system for up to 6 months or until complete recovery from BP. To investigate a relationship with the complete recovery time from BP, hematologic and baseline characteristic parameters were analyzed.
RESULTS


The complete recovery rate of the ITSI and SST groups was 47.5% and 44.8% at the 1st month, 70.5% and 89.7% at the 3rd month, and 96.7% and 100% at the 6th month of the study, respectively. Lymphocyte and neutrophil values were significantly associated with the complete recovery time from BP. No major adverse events from ITSI itself were noticed during the procedure and during the follow-up of the treatment.
CONCLUSION


Both treatment types have no superiorities over each other in initial treatment for BP in patients with comorbid diseases. ITSI is effective and safe and may avoid the unwanted side effects associated with systemic steroids inthese patients.",2020,"No major adverse events from ITSI itself were noticed during the procedure and during the follow-up of the treatment.
","['patients with comorbid diseases', 'Patients with Comorbid Disease', 'total,90 patients with comorbid diseases diagnosed with BP received either', ""Bell's palsy (BP)inpatients with diabetes mellitus (DM)and/or hypertension (HT""]","['systemic steroid treatment (SST) (control group, n=29).The facial nerve function was assessed using the House-Brackmann (HB) grading system', 'ITSI', 'intratympanic steroid injection (ITSI)as initial treatment']","['complete recovery rate', 'Lymphocyte and neutrophil values']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0376175', 'cui_str': 'Facial Paralysis, Idiopathic'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234290', 'cui_str': 'Seventh cranial nerve function (observable entity)'}, {'cui': 'C2003847', 'cui_str': 'House (environment)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.028857,"No major adverse events from ITSI itself were noticed during the procedure and during the follow-up of the treatment.
","[{'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Demir', 'Affiliation': 'Department of Otorhinolaryngology, Sakarya University School of Medicine, Sakarya, Turkey.'}, {'ForeName': 'Sena', 'Initials': 'S', 'LastName': 'Genç', 'Affiliation': 'Department of Otorhinolaryngology, Sakarya University School of Medicine, Sakarya, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Güven', 'Affiliation': 'Department of Otorhinolaryngology, Sakarya University School of Medicine, Sakarya, Turkey.'}, {'ForeName': 'Mahmut Sinan', 'Initials': 'MS', 'LastName': 'Yılmaz', 'Affiliation': 'Department of Otorhinolaryngology, Sakarya University School of Medicine, Sakarya, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Kara', 'Affiliation': 'Department of Otorhinolaryngology, Sakarya University School of Medicine, Sakarya, Turkey.'}, {'ForeName': 'Ünal', 'Initials': 'Ü', 'LastName': 'Erkorkmaz', 'Affiliation': 'Department of Biostatistics, Sakarya University School of Medicine, Sakarya, Turkey.'}]",The journal of international advanced otology,['10.5152/iao.2019.5415']
935,32406770,Development of Quality-Controlled Low-Dose Protocols for Radiography in the Neonatal ICU Using a New Mobile Digital Radiography System.,"OBJECTIVE.  The aim of this study was to develop a low-dose radiography protocol for the neonatal ICU (NICU) using a new mobile digital radiography system with advanced denoising image processing and to evaluate the noninferiority of that protocol.  SUBJECTS AND METHODS.  In this prospective randomized study, 40 neonates in the NICU underwent radiography of the thorax and abdomen with two different mobile radiography units: conventional technique on one unit (50 kV, 1.6 mAs, and no additional filtration) and a new technique on another unit (54 kV, 0.1-mm Cu filtration). Three low-dose protocols for the second unit were developed in a phantom study: protocol A (100% equivalent dose with conventional protocol), protocol B (80% equivalent dose), and protocol C (64% equivalent dose). The noninferiority of each low-dose protocol was assessed by three independent readers using image quality criteria.  RESULTS.  Forty patients each underwent three pairs of radiography examinations (protocol A and the conventional protocol, protocol B and the conventional protocol, and protocol C and the conventional protocol), except one pair that did not include one image of the conventional protocol. The interrater reliability among the three readers was 0.91 ( p  < 0.001). Both of the low-dose protocols (B and C) were statistically noninferior to the conventional protocol with respect to overall image quality. Protocol B better depicted almost all anatomic landmarks and had better overall image quality than the conventional protocol.  CONCLUSION.  Using appropriate technique and acquisition factors, radiation dose can be lowered on a digital radiography system without significant effect on the image quality by adding filtrations and a new denoising technique.",2020,"Using appropriate technique and acquisition factors, radiation dose can be lowered on a digital radiography system without significant effect on the image quality by adding filtrations and a new denoising technique.","['40 neonates in the NICU underwent radiography of the thorax and abdomen with two different mobile radiography units: conventional technique on one unit (50 kV, 1.6 mAs, and no additional filtration) and a new technique on another unit (54 kV', 'Forty patients each underwent three pairs of']","['radiography examinations (protocol A and the conventional protocol, protocol B and the conventional protocol, and protocol C and the conventional protocol), except one pair that did not include one image of the conventional protocol']","['overall image quality', 'interrater reliability']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0016107', 'cui_str': 'Filtration'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",,0.0597311,"Using appropriate technique and acquisition factors, radiation dose can be lowered on a digital radiography system without significant effect on the image quality by adding filtrations and a new denoising technique.","[{'ForeName': 'Gayoung', 'Initials': 'G', 'LastName': 'Choi', 'Affiliation': 'Department of Radiology and Institute of Radiation Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongo-gu, Seoul 03080, Korea.'}, {'ForeName': 'Jung-Eun', 'Initials': 'JE', 'LastName': 'Cheon', 'Affiliation': 'Department of Radiology and Institute of Radiation Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongo-gu, Seoul 03080, Korea.'}, {'ForeName': 'Seunghyun', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology and Institute of Radiation Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongo-gu, Seoul 03080, Korea.'}, {'ForeName': 'Young Hun', 'Initials': 'YH', 'LastName': 'Choi', 'Affiliation': 'Department of Radiology and Institute of Radiation Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongo-gu, Seoul 03080, Korea.'}, {'ForeName': 'Seung Han', 'Initials': 'SH', 'LastName': 'Shin', 'Affiliation': 'Department of Pediatrics, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Yeon Jin', 'Initials': 'YJ', 'LastName': 'Cho', 'Affiliation': 'Department of Radiology and Institute of Radiation Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongo-gu, Seoul 03080, Korea.'}, {'ForeName': 'Sun Won', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': 'Department of Radiology, Seoul National University, Seoul Metropolitan Government Boramae Medical Center, Seoul, Korea.'}]",AJR. American journal of roentgenology,['10.2214/AJR.19.22269']
936,31297968,Efficacy and safety of linagliptin to improve glucose control in older people with type 2 diabetes on stable insulin therapy: A randomized trial.,"AIM


To assess the addition of linagliptin as an alternative to insulin uptitration in older people with type 2 diabetes on stable insulin therapy.
MATERIALS AND METHODS


This phase 4, randomized, multicentre, double-blinded, placebo-controlled, 24-week study recruited individuals on stable insulin, with baseline HbA1c 7.0%-10.0%, aged ≥60 years and body mass index ≤45 kg/m 2  . HbA1c and fasting plasma glucose were measured at study visits, and participants assessed glycaemic control with a self-monitoring blood glucose device. Adverse events (AEs) were reported during the study.
RESULTS


Three hundred and two participants were randomized 1:1 to linagliptin 5 mg qd and placebo, with one third of patients from Japan. Study population age and HbA1c (baseline mean ± SD) were 72.4 ± 5.4 years and 8.2 ± 0.8%, respectively; ~80% of participants were aged ≥70 years; 80% had macrovascular complications, one third had a baseline estimated glomerular filtration rate <60 mL/min/1.73 m 2  ; and half had been diagnosed with diabetes for >15 years. Linagliptin significantly improved glucose control at 24 weeks (HbA1c-adjusted mean change vs. placebo: -0.63%; P <0.0001) and the probability of achieving predefined HbA1c targets without hypoglycaemia (HbA1c <8.0%: OR 2.02; P <0.05 and HbA1c <7.0%: OR 2.44; P <0.01). Linagliptin versus placebo was well tolerated, with similar incidences of AEs, including clinically important hypoglycaemia (blood glucose <54 mg/dL) or severe hypoglycaemia.
CONCLUSIONS


Addition of linagliptin improves glucose control without an excess of hypoglycaemia in older patients with type 2 diabetes on stable insulin therapy.",2019,Linagliptin significantly improved glucose control at 24 weeks (HbA1c-adjusted mean change vs. placebo: -0.63%; P <0.0001) and the probability of achieving predefined HbA1c targets without hypoglycaemia (HbA1c <8.0%: OR 2.02; P <0.05 and HbA1c <7.0%: OR 2.44; P <0.01).,"['older patients with type 2 diabetes on stable insulin therapy', 'older people with type 2 diabetes', 'Study population age and HbA1c (baseline mean\u2009±\u2009SD) were 72.4\u2009±\u20095.4 years and 8.2\u2009±\u20090.8%, respectively; ~80% of participants were aged ≥70\u2009years; 80% had macrovascular complications, one third had a baseline estimated glomerular filtration rate', 'older people with type 2 diabetes on stable insulin therapy', '24-week study recruited individuals on stable insulin, with baseline HbA1c 7.0%-10.0%, aged ≥60\u2009years and body mass index ≤45\u2009kg/m 2  ']","['linagliptin', 'placebo', 'Linagliptin', 'linagliptin 5 mg qd and placebo']","['severe hypoglycaemia', 'glycaemic control with a self-monitoring blood glucose device', 'glucose control', 'hypoglycaemia', 'Efficacy and safety', 'probability of achieving predefined HbA1c targets without hypoglycaemia', 'HbA1c and fasting plasma glucose', 'Adverse events (AEs']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C3811844'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3153993', 'cui_str': 'Linagliptin 5 MG'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1318607', 'cui_str': 'HBA1c target'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",302.0,0.638143,Linagliptin significantly improved glucose control at 24 weeks (HbA1c-adjusted mean change vs. placebo: -0.63%; P <0.0001) and the probability of achieving predefined HbA1c targets without hypoglycaemia (HbA1c <8.0%: OR 2.02; P <0.05 and HbA1c <7.0%: OR 2.44; P <0.01).,"[{'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Ledesma', 'Affiliation': 'Arlington Family Health Pavilion, PA, Arlington, Texas.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Morley', 'Affiliation': 'Division of Geriatric Medicine, Saint Louis University, St. Louis, Missouri.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': ""Lewis-D'Agostino"", 'Affiliation': 'Merck & Co. Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Annett', 'Initials': 'A', 'LastName': 'Keller', 'Affiliation': 'Global BDS, Boehringer Ingelheim Pharma GmbH & Co, KG, Ingelheim, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Meinicke', 'Affiliation': 'TA CardioMetabolism, Boehringer Ingelheim International GmbH, Biberach, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'van der Walt', 'Affiliation': 'International Project Management Cardiometabolic/CNS, Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'von Eynatten', 'Affiliation': 'TA CardioMetabolism, Boehringer Ingelheim International GmbH, Biberach, Germany.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13829']
937,31838589,Personal Approach to Treatment Choices for HIV (PATCH): Randomized Controlled Trial of a Brief Motivational Enhancement Intervention to Improve Medication Adherence in Persons with HIV.,"This pilot randomized controlled trial evaluated the feasibility and efficacy of a brief motivational enhancement intervention to improve adherence to antiretroviral therapy in persons with HIV called Personal Approach to Treatment Choices for HIV (PATCH). We compared PATCH to an active control condition on self-reported adherence, clinical outcomes, and psychosocial outcomes. Participants were 34 individuals (61.8% male, M age  = 47.1) receiving HIV-related services who were suboptimally engaged in care. Participants completed baseline measures, participated in either PATCH or a stress reduction skills control intervention, and completed post-treatment and 3-month follow-up assessments. Results revealed no differences between conditions on adherence or clinical outcomes. At post-treatment, PATCH participants reported greater improvements in alcohol use, psychiatric symptoms, subjective mental functioning, and emotion-focused coping; improvements in subjective mental functioning were maintained at 3-months. Results suggest that motivational enhancement interventions can improve psychosocial outcomes for people with HIV. That some improvements were not maintained at follow-up suggests that effects wane over time and longer treatment may be indicated for lasting effects.",2020,"At post-treatment, PATCH participants reported greater improvements in alcohol use, psychiatric symptoms, subjective mental functioning, and emotion-focused coping; improvements in subjective mental functioning were maintained at 3-months.","['people with HIV', 'HIV (PATCH', 'Persons with HIV', 'Participants were 34 individuals (61.8% male, M age \u2009=\u200947.1) receiving HIV-related services who were suboptimally engaged in care', 'persons with HIV called Personal Approach to Treatment Choices for HIV (PATCH']","['motivational enhancement intervention', 'Motivational Enhancement Intervention', 'motivational enhancement interventions', 'PATCH or a stress reduction skills control intervention, and completed post-treatment and 3-month follow-up assessments']","['psychosocial outcomes', 'Medication Adherence', 'alcohol use, psychiatric symptoms, subjective mental functioning, and emotion-focused coping; improvements in subjective mental functioning']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0580931', 'cui_str': 'In care (finding)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}]",34.0,0.0572077,"At post-treatment, PATCH participants reported greater improvements in alcohol use, psychiatric symptoms, subjective mental functioning, and emotion-focused coping; improvements in subjective mental functioning were maintained at 3-months.","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Scharer', 'Affiliation': 'Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Arnold', 'Affiliation': 'Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Wald', 'Affiliation': 'Minds in Focus Psychological Services, Baltimore, MD, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Nichols', 'Affiliation': 'Mount Sinai Hospital, New York, NY, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Medoff', 'Affiliation': 'Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Himelhoch', 'Affiliation': 'Department of Psychiatry, University of Kentucky College of Medicine, Lexington, KY, USA.'}, {'ForeName': 'Melanie E', 'Initials': 'ME', 'LastName': 'Bennett', 'Affiliation': 'Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA. mbennett@som.umaryland.edu.'}]",AIDS and behavior,['10.1007/s10461-019-02759-3']
938,31228760,"Analgesia-first sedation in critically ill adults: A U.S. pilot, randomized controlled trial.","PURPOSE


To determine the feasibility of conducting a multicenter ICU RCT of AFS compared to either protocol-directed sedation (PDS) or both PDS and daily sedation interruption (DSI) in North America.
MATERIALS AND METHODS


This single-center RCT compared AFS [fentanyl (bolus ± infusions) to reach CPOT ≤2; if RASS ≥1, CPOT ≤2 and additional fentanyl failed to reach RASS goal (-2 to 0), low-dose propofol (up to 6 h) was given] with either PDS or both PDS and DSI daily in adults mechanically ventilated (MV) ≥48 h. Relevant feasibility, safety, and clinical outcomes were defined and evaluated.
RESULTS


90 of 160 eligible patients were enrolled [AFS = 27; PDS = 28; PDS + DSI = 31]; rate = 3/month. Time from intubation to randomization was 17.5 ± 11.6 h. Study days fully adherent to the study intervention [AFS = 95%; PDS = 99%; PDS + DSI = 96%] and time spent in the first 48 h after randomization without pain (CPOT ≤2)[AFS = 82%; PDS = 78%; PDS + DSI = 77%] and at goal RASS[AFS = 88%; PDS = 83%; PDS + DSI = 95%] were high and similar. Nurse-perceived [median (IQR)] study workload (10-point VAS) was higher with AFS [4(2-6)] than PDS [1(1-3)] or PDS + DSI [2(1-5)]; p = .002). Unplanned extubation was rare (AFS = 1; PDS = 0; PDS + DSI = 1). Days [median (IQR)] free of MV in the 28d after intubation [AFS 24(23,26); PDS 24(20,26); PDS + DSI 24(21,26)] was not different (p = .62).
CONCLUSION


A multicenter RCT evaluating AFS is feasible to conduct in North America.",2019,study workload (10-point VAS) was higher with AFS [4(2-6)] than PDS [1(1-3)] or PDS + DSI [2(1-5)];,"['North America', '90 of 160 eligible patients were enrolled [AFS\u202f=\u202f27; PDS\u202f=\u202f28; PDS\u202f+\u202fDSI\u202f=\u202f31]; rate\u202f=\u202f3/month', 'critically ill adults']","['Analgesia-first sedation', 'protocol-directed sedation (PDS) or both PDS and daily sedation interruption (DSI', 'propofol']","['Nurse-perceived [median (IQR', 'study workload (10-point VAS', 'Days [median (IQR)] free of MV', 'PDS 24(20,26); PDS\u202f+\u202fDSI 24(21,26', 'time spent', 'Unplanned extubation']","[{'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}]",160.0,0.108096,study workload (10-point VAS) was higher with AFS [4(2-6)] than PDS [1(1-3)] or PDS + DSI [2(1-5)];,"[{'ForeName': 'Maged', 'Initials': 'M', 'LastName': 'Tanios', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, MemorialCare Long Beach Medical Center, Long Beach, CA, United States of America.'}, {'ForeName': 'Huan Mark', 'Initials': 'HM', 'LastName': 'Nguyen', 'Affiliation': 'Department of Pharmacy Practice and Administration, Western University of Health Sciences, Pomona, CA, United States of America.'}, {'ForeName': 'Hyunsoon', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Nursing, MemorialCare Long Beach Medical Center, Long Beach, CA, United States of America.'}, {'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Department of Critical Care, Sinai Health System and Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Scott K', 'Initials': 'SK', 'LastName': 'Epstein', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center, United States of America.'}, {'ForeName': 'Fady', 'Initials': 'F', 'LastName': 'Youssef', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, MemorialCare Long Beach Medical Center, Long Beach, CA, United States of America.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Beltran', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, MemorialCare Long Beach Medical Center, Long Beach, CA, United States of America.'}, {'ForeName': 'Gabe', 'Initials': 'G', 'LastName': 'Flores', 'Affiliation': 'Department of Critical Care, Universidad Autonoma de Guadalajara School of Medicine, Guadalajara, Mexico.'}, {'ForeName': 'Ramy', 'Initials': 'R', 'LastName': 'Sidhom', 'Affiliation': 'Department of Internal Medicine, University of California Medical Center, Orange, CA, United States of America.'}, {'ForeName': 'Arunpal', 'Initials': 'A', 'LastName': 'Sehgal', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, MemorialCare Long Beach Medical Center, Long Beach, CA, United States of America.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Leo', 'Affiliation': 'Department of Medicine, MemorialCare Health System, Fountain Valley, CA, United States of America.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Devlin', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center, United States of America; School of Pharmacy, Northeastern University, Boston, MA, United States of America. Electronic address: j.devlin@neu.edu.'}]",Journal of critical care,['10.1016/j.jcrc.2019.06.008']
939,31174172,Variability in triage practices for critically ill cancer patients: A randomized controlled trial.,"PURPOSE


Intensive care triage practices and end-user interpretation of triage guidelines have rarely been assessed. We evaluated agreement between providers on the prioritization of patients for ICU admission using different triage guidelines.
MATERIALS AND METHODS


A multi-centered randomized study on providers from 18 different countries was conducted using clinical vignettes of oncological patients. The level of agreement between providers was measured using two different guidelines, with one being cancer specific.
RESULTS


Amongst 257 providers, 52.5% randomly received the Society of Critical Care Prioritization Model, and 47.5% received a cancer specific flowchart as a guide. In the Prioritization Model arm the average entropy was 1.193, versus 1.153 in the flowchart arm (P = .095) indicating similarly poor agreement. The Fleiss' kappa coefficients were estimated to be 0.2136 for the SCCMPM arm and 0.2457 for the flowchart arm, also similarly implying poor agreement.
CONCLUSIONS


The low agreement amongst practitioners on the prioritization of cancer patient cases for ICU admission existed using both general triage guidelines and guidelines tailored only to cancer patients. The lack of consensus on intensive care unit triage practices in the oncological population exposes a potential barrier to appropriate resource allocation that needs to be addressed.",2019,The low agreement amongst practitioners on the prioritization of cancer patient cases for ICU admission existed using both general triage guidelines and guidelines tailored only to cancer patients.,"['critically ill cancer patients', 'providers from 18 different countries was conducted using clinical vignettes of oncological patients']",[],"[""Fleiss' kappa coefficients"", 'average entropy']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",[],"[{'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}]",,0.0951624,The low agreement amongst practitioners on the prioritization of cancer patient cases for ICU admission existed using both general triage guidelines and guidelines tailored only to cancer patients.,"[{'ForeName': 'Nisha K', 'Initials': 'NK', 'LastName': 'Rathi', 'Affiliation': 'Department of Critical Care, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Unit 112, Houston, TX 77030, United States of America. Electronic address: nrathi@mdanderson.org.'}, {'ForeName': 'Sajid A', 'Initials': 'SA', 'LastName': 'Haque', 'Affiliation': 'Department of Critical Care, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Unit 112, Houston, TX 77030, United States of America. Electronic address: shaque@mdanderson.org.'}, {'ForeName': 'Freddy', 'Initials': 'F', 'LastName': 'Morales', 'Affiliation': 'Hospital Oncológico ""Dr. Julio Villacreses Colmont"" SOLCA Manabí, Núcleo de Portoviejo, Autopista del Valle Manabí Guillen en Portoviejo, Manibi, Ecuador.'}, {'ForeName': 'Bhavika', 'Initials': 'B', 'LastName': 'Kaul', 'Affiliation': 'Department of Critical Care, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Unit 112, Houston, TX 77030, United States of America. Electronic address: Bhavika.kaul@ucsf.edu.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Ramirez', 'Affiliation': 'Department of Critical Care, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Unit 112, Houston, TX 77030, United States of America. Electronic address: rramirezfernand@augusta.edu.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Ovu', 'Affiliation': 'Department of Critical Care, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Unit 112, Houston, TX 77030, United States of America. Electronic address: Sto9021@nyp.org.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, United States of America. Electronic address: leifeng@mdanderson.org.'}, {'ForeName': 'Wenli', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, United States of America. Electronic address: wdong@mdanderson.org.'}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Price', 'Affiliation': 'Department of Critical Care, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Unit 112, Houston, TX 77030, United States of America. Electronic address: kjprice@mdanderson.org.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Ugarte', 'Affiliation': ""INDISA Clinic, Salvador's Hospital, Avenida Santa Maria 1810, Providencia Region Metropolitana, Santiago, Chile.""}, {'ForeName': 'Nestor', 'Initials': 'N', 'LastName': 'Raimondi', 'Affiliation': 'Juan A. Fernandez Hospital, Cervino 3356, C1425AGP CABA, Buenos Aires, Argentina.'}, {'ForeName': 'Agamenon', 'Initials': 'A', 'LastName': 'Quintero', 'Affiliation': 'Imatoncomedica S.A., Carrera 6A #72-34, Monteria, Cordoba, Colombia.'}, {'ForeName': 'Yenny R', 'Initials': 'YR', 'LastName': 'Cardenas', 'Affiliation': 'Critical Care Department, Universidad del Rosario, Hospital Universitario Fundacion Santa Fe de Bogota, Carrera 7 No. 117 - 15, Bogota DC, Colombia.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Nates', 'Affiliation': 'Department of Critical Care, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Unit 112, Houston, TX 77030, United States of America. Electronic address: jlnates@mdanderson.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of critical care,['10.1016/j.jcrc.2019.05.012']
940,31282418,Can Adults with Mild Cognitive Impairment Build Cognitive Reserve and Learn Mindfulness Meditation? Qualitative Theme Analyses from a Small Pilot Study.,"BACKGROUND/OBJECTIVE


High levels of chronic stress negatively impact the hippocampus and are associated with increased incidence of mild cognitive impairment (MCI) and Alzheimer's disease. While mindfulness meditation may mitigate the effects of chronic stress, it is uncertain if adults with MCI have the capacity to learn mindfulness meditation.
METHODS


14 adults with MCI were randomized 2:1 to Mindfulness Based Stress Reduction (MBSR) or a wait-list control group. We conducted qualitative interviews with those who completed MBSR. Transcribed interviews were: a) coded using an emergent themes inductive approach informed by grounded theory; b) rated 0-10, with higher scores reflecting greater perceived benefit from, and understanding of, mindfulness meditation. Ratings were correlated with daily home practice times and baseline level of cognitive function.
RESULTS


Seven themes emerged from the interviews: positive perceptions of class; development of mindfulness skills, including meta-cognition; importance of the group experience; enhanced well-being; shift in MCI perspective; decreased stress reactivity and increased relaxation; improvement in interpersonal skills. Ratings of perceived benefit and understanding ranged from 2-10 (mean = 7) and of 0-9.5 (mean = 6), respectively. Many participants experienced substantial benefit/understanding, some had moderate, and a few had minimal benefit/understanding. Understanding the key concepts of mindfulness was highly positively correlated with ≥20 minutes/day of home practice (r = 0.90) but not with baseline cognitive function (r = 0.13).
CONCLUSIONS


Most adults with MCI were able to learn mindfulness meditation and had improved MCI acceptance, self-efficacy, and social engagement. Cognitive reserve may be enhanced through a mindfulness meditation program even in patients with MCI.",2019,"CONCLUSIONS


Most adults with MCI were able to learn mindfulness meditation and had improved MCI acceptance, self-efficacy, and social engagement.","['14 adults with MCI', 'patients with MCI']",['Mindfulness Based Stress Reduction (MBSR) or a wait-list control group'],"['Cognitive reserve', 'positive perceptions of class; development of mindfulness skills, including meta-cognition; importance', 'daily home practice times and baseline level of cognitive function', 'MCI acceptance, self-efficacy, and social engagement', 'stress reactivity and increased relaxation; improvement in interpersonal skills']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2936352', 'cui_str': 'Brain Reserve'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0589513', 'cui_str': 'Meta-cognition'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}]",14.0,0.0172474,"CONCLUSIONS


Most adults with MCI were able to learn mindfulness meditation and had improved MCI acceptance, self-efficacy, and social engagement.","[{'ForeName': 'Rebecca Erwin', 'Initials': 'RE', 'LastName': 'Wells', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Kerr', 'Affiliation': 'Department of Family Medicine and Mindfulness-Wellness Program, Brown University School of Medicine, Providence, RI, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Dossett', 'Affiliation': 'Department of Medicine and Benson-Henry Institute for Mind Body Medicine, Division of General Internal Medicine, Massachusetts General Hospital; and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'Danhauer', 'Affiliation': 'Department of Social Sciences and Health Policy, Division of Public Health Sciences, Wake Forest School of Medicine, Winston Salem, NC, USA.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Sohl', 'Affiliation': 'Department of Social Sciences and Health Policy, Division of Public Health Sciences, Wake Forest School of Medicine, Winston Salem, NC, USA.'}, {'ForeName': 'Bonnie C', 'Initials': 'BC', 'LastName': 'Sachs', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Jacquelyn Walsh', 'Initials': 'JW', 'LastName': 'Feeley', 'Affiliation': 'Graduate School of Nursing, University of Massachusetts Medical School, Worcester, MA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wolkin', 'Affiliation': 'BrainCurves, New York, NY, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wall', 'Affiliation': 'Mclean Hospital Borden Cottage, Camden, ME, USA.'}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Kaptchuk', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Daniel Z', 'Initials': 'DZ', 'LastName': 'Press', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Russell S', 'Initials': 'RS', 'LastName': 'Phillips', 'Affiliation': 'Department of Medicine, Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Gloria Y', 'Initials': 'GY', 'LastName': 'Yeh', 'Affiliation': 'Department of Medicine, Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190191']
941,32406783,A Robotic Camera Holder Controlled by Head Movements: Exploring This New Robot-Surgeon Interface.,"Background.  Most robotic camera steering devices (RCSDs) require active steering by the surgeon and necessarily increase workload. Clinical experience shows that standard laparoscopic procedures can be performed safely as solo surgery aided by RCSDs. No evidence exists concerning exploratory or emergency procedures. We compared the performance during unexpected laparoscopic tasks on surgical simulators aided either by an RCSD controllable by head movements of the surgeon or by a human camera assistant.  Methods.  Forty-five medical students without previous experience with minimal invasive surgery were randomized in 2 groups, and they performed standard and unexpected laparoscopic tasks requiring complex camera movements on box trainers either using an RCSD or assisted by a human camera assistant. Efficiency and performance parameters were recorded.  Results.  Performance in simulated standard procedures was equivalent. In simulated exploratory procedures, we saw significantly better performance scores in the conventional group versus the RCSD group. The strongest factor for these differences was the longer camera-adjusting time in the RCSD group versus the conventional group (PEG task = 208 ± 51 seconds vs 170 ± 36 seconds,  P  = .005; suture task = 563 ± 126 seconds vs 454 ± 201 seconds,  P  = .041).  Conclusion.  These results, obtained on surgical simulators, indicate that the solo approach to standard surgical tasks, facilitated by an RCSD controllable by head movements, can most likely be viewed as safe. Exploratory procedures with a relevant chance for complications or procedures that require rapid, often, or complex camera movements should rather be performed with a human camera assistant.",2020,Performance in simulated standard procedures was equivalent.,"['Head Movements', 'Forty-five medical students without previous experience with minimal invasive surgery']","['standard laparoscopic procedures', 'robotic camera steering devices (RCSDs', 'standard and unexpected laparoscopic tasks requiring complex camera movements on box trainers either using an RCSD or assisted by a human camera assistant', 'RCSD controllable by head movements of the surgeon or by a human camera assistant']","['Efficiency and performance parameters', 'performance scores']","[{'cui': 'C0376591', 'cui_str': 'Head Movements'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0553654', 'cui_str': 'Does steer'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0376591', 'cui_str': 'Head Movements'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0290005,Performance in simulated standard procedures was equivalent.,"[{'ForeName': 'Julian Nikolaus', 'Initials': 'JN', 'LastName': 'Bucher', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Bruewer', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Louisa Jutta', 'Initials': 'LJ', 'LastName': 'Dietz', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Trebesius', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Hidding', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Wysocki', 'Affiliation': 'Jagiellonian University, Kraków, Poland.'}, {'ForeName': 'Markus Bo', 'Initials': 'MB', 'LastName': 'Schoenberg', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Werner', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Karcz', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Ludwig-Maximilians-University, Munich, Germany.'}]",Surgical innovation,['10.1177/1553350620916573']
942,31268268,The influence of biphasic positive airway pressure vs. sham biphasic positive airway pressure on pulmonary function in morbidly obese patients after bariatric surgery.,"BACKGROUND


The effect of biphasic positive airway pressure (BPAP) at individualized pressures on the postoperative pulmonary recovery of morbidly obese patients (MOP) undergoing open bariatric surgery (OBS) and possible <i><i><i>placebo</i></i></i> device-related effects (sham BPAP) were investigated.
METHODS


Forty-eight MOP scheduled for OBS were initially enrolled. Subjects were randomly assigned to: A) the BPAP group in which BPAP, at individualized inspiratory positive airway pressure/expiratory positive airway pressure (IPAP/EPAP), was applied for 3 days postoperatively and B) the sham BPAP group in which sham BPAP was applied for the same time. Pulmonary function was assessed by spirometry 24 h prior to surgery and at 24, 48 and 72 h postoperatively and respiratory complications were recorded.
RESULTS


Thirty-five subjects, 21 in the BPAP group and 14 in the sham BPAP group, completed the study. Baseline characteristics and pulmonary function were similar between groups preoperatively. Subjects in the BPAP group showed in general better spirometric performance and SpO2 values postoperatively and expedited pulmonary recovery. Atelectasis combined with respiratory distress syndrome (RDS) symptoms was observed in 21% of subjects in the sham BPAP group and one of these subjects developed lower respiratory tract infection. No respiratory complications were recorded in the BPAP group. Use of higher BPAP pressures was not associated with anastomosis leakage or disruption in any patient.
CONCLUSION


Use of BPAP, at individualized pressures, expedites postoperative pulmonary recovery and eliminates respiratory complications in MOP who have undergone OBS.",2019,Subjects in the BPAP group showed in general better spirometric performance and SpO2 values postoperatively and expedited pulmonary recovery.,"['morbidly obese patients (MOP) undergoing', 'Thirty-five subjects, 21 in the BPAP group and 14 in the sham BPAP group, completed the study', 'morbidly obese patients after bariatric surgery', 'Forty-eight MOP scheduled for OBS were initially enrolled']","['biphasic positive airway pressure vs. sham biphasic positive airway pressure', 'BPAP group in which BPAP, at individualized inspiratory positive airway pressure/expiratory positive airway pressure (IPAP/EPAP', 'BPAP', 'sham BPAP', 'open bariatric surgery (OBS) and possible <i><i><i>placebo</i></i></i> device-related effects (sham BPAP', 'sham BPAP group in which sham BPAP', 'biphasic positive airway pressure (BPAP']","['general better spirometric performance and SpO2 values postoperatively and expedited pulmonary recovery', 'Pulmonary function', 'lower respiratory tract infection', 'respiratory distress syndrome (RDS) symptoms', 'respiratory complications', 'Baseline characteristics and pulmonary function']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0066823', 'cui_str': 'morpholinopropane sulfonic acid'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]","[{'cui': 'C0205184', 'cui_str': 'Biphasic (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C3697361', 'cui_str': 'Expiratory positive airway pressure'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0035220', 'cui_str': 'Respiratory Distress Syndrome, Newborn'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0161818', 'cui_str': 'Respiratory complication'}]",,0.0991337,Subjects in the BPAP group showed in general better spirometric performance and SpO2 values postoperatively and expedited pulmonary recovery.,"[{'ForeName': 'Aikaterini N', 'Initials': 'AN', 'LastName': 'Alexandropoulou', 'Affiliation': 'Department of Anesthesiology, Evangelismos General Hospital, Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Louis', 'Affiliation': '3rd Department of Obstetrics-Gynaecology, ""Attikon"" University Hospital, Medical School, National Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Papakonstantinou', 'Affiliation': 'Organ Transplantation Unit, 1st Department of General Surgery, Evangelismos General Hospital, Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Tzirogiannis', 'Affiliation': '2nd Department of Internal Medicine, Elpis General Hospital, Athens, Greece.'}, {'ForeName': 'Elissavet', 'Initials': 'E', 'LastName': 'Stamataki', 'Affiliation': 'Department of Anesthesiology, Evangelismos General Hospital, Athens, Greece.'}, {'ForeName': 'Charis', 'Initials': 'C', 'LastName': 'Roussos', 'Affiliation': 'Center of Sleep Disorders, Department of Critical Care and Pulmonary Services, Evangelismos General Hospital, School of Medicine, National Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Manos', 'Initials': 'M', 'LastName': 'Alchanatis', 'Affiliation': 'Sotiria Hospital of Chest Diseases, School of Medicine, National Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Gratziou', 'Affiliation': 'Department of Pulmonary Medicine, Evgenidio Hospital, National Kapodistrian University of Athens, School of Medicine, Athens, Greece.'}, {'ForeName': 'Emanouil', 'Initials': 'E', 'LastName': 'Vagiakis', 'Affiliation': 'Center of Sleep Disorders, Department of Critical Care and Pulmonary Services, Evangelismos General Hospital, School of Medicine, National Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Roditis', 'Affiliation': ""Junior Doctors' Network-Hellas (JDN-Hellas), Athens, Greece.""}]",Anaesthesiology intensive therapy,['10.5114/ait.2019.85868']
943,32409830,A phase III randomized controlled trial comparing surgery plus adjuvant chemotherapy with preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy for locally recurrent rectal cancer: Japan Clinical Oncology Group study JCOG1801 (RC-SURVIVE study).,"A randomized phase III trial was initiated in Japan in August 2019 to confirm the superiority of preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy compared to the standard treatment, i.e. surgery plus adjuvant chemotherapy, for locally recurrent rectal cancer in local relapse-free survival. In all, 110 patients from 43 Japanese institutions will be recruited over a period of 6 years. Eligible patients would be registered and randomly assigned to each group with an allocation ratio of 1:1. The primary endpoint is local relapse-free survival. The secondary endpoints are overall survival, relapse-free survival, proportion of local relapse, proportion of distant relapse, proportion of patients with pathological R0 resection, response rate of preoperative chemoradiotherapy (preoperative chemoradiotherapy arm), pathological complete response rate (preoperative chemoradiotherapy arm), proportion of patients who completed the protocol treatment, incidence of adverse events (adverse reactions) and quality of life after surgery. This trial has been registered at the Japan Registry of Clinical Trial: jRCTs031190076 [https://jrct.niph.go.jp/latest-detail/jRCTs031190076] and ClinicalTrials.gov: NCT04288999 [https://clinicaltrials.gov/ct2/show/NCT04288999].",2020,"The secondary endpoints are overall survival, relapse-free survival, proportion of local relapse, proportion of distant relapse, proportion of patients with pathological R0 resection, response rate of preoperative chemoradiotherapy (preoperative chemoradiotherapy arm), pathological complete response rate (preoperative chemoradiotherapy arm), proportion of patients who completed the protocol treatment, incidence of adverse events (adverse reactions) and quality of life after surgery.","['locally recurrent rectal cancer', '110 patients from 43 Japanese institutions will be recruited over a period of 6\xa0years', 'Eligible patients']","['preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy', 'surgery plus adjuvant chemotherapy with preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy']","['local relapse-free survival', 'overall survival, relapse-free survival, proportion of local relapse, proportion of distant relapse, proportion of patients with pathological R0 resection, response rate of preoperative chemoradiotherapy (preoperative chemoradiotherapy arm), pathological complete response rate (preoperative chemoradiotherapy arm), proportion of patients who completed the protocol treatment, incidence of adverse events (adverse reactions) and quality of life after surgery']","[{'cui': 'C0278554', 'cui_str': 'Rectal cancer recurrent'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",110.0,0.319184,"The secondary endpoints are overall survival, relapse-free survival, proportion of local relapse, proportion of distant relapse, proportion of patients with pathological R0 resection, response rate of preoperative chemoradiotherapy (preoperative chemoradiotherapy arm), pathological complete response rate (preoperative chemoradiotherapy arm), proportion of patients who completed the protocol treatment, incidence of adverse events (adverse reactions) and quality of life after surgery.","[{'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Kadota', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Tsukada', 'Affiliation': 'Department of Colorectal Surgery, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'Department of Colorectal Surgery, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Katayama', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Junki', 'Initials': 'J', 'LastName': 'Mizusawa', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Nakamura', 'Affiliation': 'Department of Radiation Oncology and Particle Therapy, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Department of Radiation Oncology, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Bando', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Onaya', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Fukuda', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yukihide', 'Initials': 'Y', 'LastName': 'Kanemitsu', 'Affiliation': 'Department of Colorectal Surgery, National Cancer Center Hospital, Tokyo, Japan.'}]",Japanese journal of clinical oncology,['10.1093/jjco/hyaa058']
944,31679621,Early and Mid-Term Vascular Responses to Optical Coherence Tomography-Guided Everolimus-Eluting Stent Implantation in Stable Coronary Artery Disease.,"BACKGROUND


Analysis of pooled clinical data has shown the safety of 3 months of dual antiplatelet therapy with everolimus-eluting cobalt-chromium stents (Co-Cr EESs). This study evaluated early and mid-term vascular responses to Co-Cr EESs in patients with stable coronary artery disease.
METHODS


The Multicenter Comparison of Early and Late Vascular Responses to Everolimus-Eluting Cobalt-Chromium Stent and Platelet Aggregation Studies in Patients With Stable Angina Managed as Elective Case (MECHANISM-Elective) study (NCT02014818) is a multicenter optical coherence tomography (OCT) registry. Enrolled patients were evaluated by OCT immediately after everolimus-eluting stent implantation were prospectively allocated to 1 month (n = 50) or 3 months (n = 50) OCT follow-up and then received a 12-month OCT evaluation. The incidences of intrastent thrombus (IS-Th) and irregular protrusion (IRP) were also assessed.
RESULTS


The percentage of uncovered struts was 6.4% ± 10.3% at 1 month (P < 0.001 vs. postprocedure) and 0.5% ± 0.9% at 12 months (P < 0.001 vs. 1 month). The corresponding values in the 3-month cohort were 2.0% ± 2.5% (P < 0.001 vs. postprocedure) and 0.5% ± 1.5% (P < 0.001 vs. 3 months). The incidence of IS-Th was 32.7% at 1 month, 5.4% at 3 months, and 2.0% at 12 months. IRP was observed in 21.8% of patients post-EES but had totally resolved at 1, 3, and 12 months.
CONCLUSION


Early and mid-term vascular reactions after Co-Cr EES implantation in stable patients with coronary artery disease in the MECHANISM-Elective included dynamic resolution of IS-Th and IRP and rapid decrease in uncovered struts. Thus, EES may allow shortening of dual antiplatelet therapy duration less than 3 months in this patient subset.",2019,The percentage of uncovered struts was 6.4% ± 10.3% at 1 month (P < 0.001 vs. postprocedure) and 0.5% ± 0.9% at 12 months (P < 0.001 vs. 1 month).,"['stable patients with coronary artery disease', 'Patients', 'Enrolled patients were evaluated by OCT immediately after everolimus-eluting stent implantation', 'patients with stable coronary artery disease', 'Stable Coronary Artery Disease']","['Optical Coherence Tomography-Guided Everolimus-Eluting Stent Implantation', 'Early and mid-term vascular reactions after Co-Cr EES implantation', 'Co-Cr EESs', 'everolimus-eluting cobalt-chromium stents (Co-Cr EESs', 'Everolimus-Eluting Cobalt-Chromium Stent']","['IRP', 'incidences of intrastent thrombus (IS-Th) and irregular protrusion (IRP']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0008574', 'cui_str': 'Chromium'}]","[{'cui': 'C0205271', 'cui_str': 'Irregular'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}]",50.0,0.0322582,The percentage of uncovered struts was 6.4% ± 10.3% at 1 month (P < 0.001 vs. postprocedure) and 0.5% ± 0.9% at 12 months (P < 0.001 vs. 1 month).,"[{'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Shinke', 'Affiliation': 'Kobe University Graduate School of Medicine, Kobe, Japan; Showa University School of Medicine, Tokyo, Japan. Electronic address: shinke@med.showa-u.ac.jp.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Itoh', 'Affiliation': 'Iwate Medical University, Morioka, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Ishida', 'Affiliation': 'Iwate Medical University, Morioka, Japan.'}, {'ForeName': 'Hiromasa', 'Initials': 'H', 'LastName': 'Otake', 'Affiliation': 'Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Terashita', 'Affiliation': 'Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Fusazaki', 'Affiliation': 'Iwate Medical University, Morioka, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Kikuchi', 'Affiliation': 'Edogawa Hospital, Tokyo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Okamura', 'Affiliation': 'Yamaguchi University Graduate School of Medicine, Ube, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Morita', 'Affiliation': 'Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'Himeji Cardiovascular Center, Himeji, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Sawada', 'Affiliation': 'Himeji Cardiovascular Center, Himeji, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Yasaka', 'Affiliation': 'Kobe University Graduate School of Medicine, Kobe, Japan; Himeji Cardiovascular Center, Himeji, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Awaji Medical Center, Sumoto, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Matsuura', 'Affiliation': 'Akashi Medical Center, Akashi, Japan.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Kawata', 'Affiliation': 'Akashi Medical Center, Akashi, Japan.'}, {'ForeName': 'Amane', 'Initials': 'A', 'LastName': 'Kozuki', 'Affiliation': 'Osaka Saiseikai Nakatsu Hospital, Osaka, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Shite', 'Affiliation': 'Osaka Saiseikai Nakatsu Hospital, Osaka, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Kataoka', 'Affiliation': 'Bell Land General Hospital, Sakai, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Hibi', 'Affiliation': 'Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Shozo', 'Initials': 'S', 'LastName': 'Ishihara', 'Affiliation': 'Mimihara General Hospital, Sakai, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Akasaka', 'Affiliation': 'Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kubo', 'Affiliation': 'Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Ino', 'Affiliation': 'Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Shinjo', 'Initials': 'S', 'LastName': 'Sonoda', 'Affiliation': 'University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Jungo', 'Initials': 'J', 'LastName': 'Furuya', 'Affiliation': 'Hokkaido Social Insurance Hospital, Sapporo, Japan.'}, {'ForeName': 'Teppei', 'Initials': 'T', 'LastName': 'Sugaya', 'Affiliation': 'Hokkaido Social Insurance Hospital, Sapporo, Japan.'}, {'ForeName': 'Yoshisato', 'Initials': 'Y', 'LastName': 'Shibata', 'Affiliation': 'Miyazaki Medical Association Hospital, Miyazaki, Japan.'}, {'ForeName': 'Nehiro', 'Initials': 'N', 'LastName': 'Kuriyama', 'Affiliation': 'Miyazaki Medical Association Hospital, Miyazaki, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Igarashi', 'Affiliation': 'Kobe Red Cross Hospital, Kobe, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Matsumoto', 'Affiliation': 'Yodogawa Christian Hospital, Osaka, Japan.'}, {'ForeName': 'Noritoshi', 'Initials': 'N', 'LastName': 'Hiranuma', 'Affiliation': 'Ako City Hospital, Ako, Japan.'}, {'ForeName': 'Yoritaka', 'Initials': 'Y', 'LastName': 'Otsuka', 'Affiliation': 'Fukuoka Wajiro Hospital, Fukuoka, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Morino', 'Affiliation': 'Iwate Medical University, Morioka, Japan.'}]",The Canadian journal of cardiology,['10.1016/j.cjca.2019.07.633']
945,32409778,A pragmatic randomized controlled trial testing the effects of the international scientific SCI exercise guidelines on SCI chronic pain: protocol for the EPIC-SCI trial.,"STUDY DESIGN


Protocol for a pragmatic randomized controlled trial (the Exercise guideline Promotion and Implementation in Chronic SCI [EPIC-SCI] Trial).
PRIMARY OBJECTIVES


To test if home-/community-based exercise, prescribed according to the international SCI exercise guidelines, significantly reduces chronic bodily pain in adults with SCI.
SECONDARY OBJECTIVES


To investigate: (1) the effects of exercise on musculoskeletal and neuropathic chronic pain; (2) if reduced inflammation and increased descending inhibitory control are viable pathways by which exercise reduces pain; (3) the effects of chronic pain reductions on subjective well-being; and (4) efficiency of a home-/community-based exercise intervention.
SETTING


Exercise in home-/community-based settings; assessments in university-based laboratories in British Columbia, Canada.
METHOD


Eighty-four adults with chronic SCI, reporting chronic musculoskeletal or neuropathic pain, and not meeting the current SCI exercise guidelines, will be recruited and randomized to a 6-month Exercise or Wait-List Control condition. Exercise will occur in home/community settings and will be supported through behavioral counseling. All measures will be taken at baseline, 3-months and 6-months. Analyses will consist of linear mixed effect models, multiple regression analyses and a cost-utility analysis. The economic evaluation will examine the incremental costs and health benefits generated by the intervention compared with usual care.
ETHICS AND DISSEMINATION


The University of British Columbia Clinical Research Ethics Board approved the protocol (#H19-01650). Using an integrated knowledge translation approach, stakeholders will be engaged throughout the trial and will co-create and disseminate evidence-based recommendations and messages regarding the use of exercise to manage SCI chronic pain.",2020,"Using an integrated knowledge translation approach, stakeholders will be engaged throughout the trial and will co-create and disseminate evidence-based recommendations and messages regarding the use of exercise to manage SCI chronic pain.","['adults with SCI', 'Exercise in home-/community-based settings; assessments in university-based laboratories in British Columbia, Canada', 'Eighty-four adults with chronic SCI, reporting chronic musculoskeletal or neuropathic pain, and not meeting the current SCI exercise guidelines']","['home-/community-based exercise intervention', 'international scientific SCI exercise guidelines', '6-month Exercise or Wait-List Control condition', 'exercise']","['chronic bodily pain', 'musculoskeletal and neuropathic chronic pain', 'SCI chronic pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0006193', 'cui_str': 'British Columbia'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]",84.0,0.155033,"Using an integrated knowledge translation approach, stakeholders will be engaged throughout the trial and will co-create and disseminate evidence-based recommendations and messages regarding the use of exercise to manage SCI chronic pain.","[{'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Martin Ginis', 'Affiliation': 'Department of Medicine, Division of Physical Medicine and Rehabilitation, University of British Columbia, Vancouver, BC, Canada. kathleen_martin.ginis@ubc.ca.'}, {'ForeName': 'Jan W', 'Initials': 'JW', 'LastName': 'van der Scheer', 'Affiliation': 'Department of Medicine, Division of Physical Medicine and Rehabilitation, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Kendra R', 'Initials': 'KR', 'LastName': 'Todd', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Davis', 'Affiliation': 'Centre for Chronic Disease Prevention and Management, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Gaudet', 'Affiliation': 'Spinal Cord Injury British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Hoekstra', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Mohammad Ehsanul', 'Initials': 'ME', 'LastName': 'Karim', 'Affiliation': 'School of Population and Public Health and Centre for Health Evaluation and Outcome Sciences, Providence Health Care, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'John L K', 'Initials': 'JLK', 'LastName': 'Kramer', 'Affiliation': 'International Collaboration on Repair Discoveries (ICORD), University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Jonathan Peter', 'Initials': 'JP', 'LastName': 'Little', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': 'School of Population and Public Health, UBC; Centre for Health Evaluation and Outcome Sciences, Vancouver, BC, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Townson', 'Affiliation': 'Department of Medicine, Division of Physical Medicine and Rehabilitation, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'West', 'Affiliation': 'International Collaboration on Repair Discoveries (ICORD), University of British Columbia, Vancouver, BC, Canada.'}]",Spinal cord,['10.1038/s41393-020-0478-7']
946,31202690,"Low-dose ritonavir-boosted darunavir once daily versus ritonavir-boosted lopinavir for participants with less than 50 HIV RNA copies per mL (WRHI 052): a randomised, open-label, phase 3, non-inferiority trial.","BACKGROUND


Pilot studies suggest that ritonavir-boosted darunavir could show high efficacy at doses below those currently approved. We investigated whether switch to 400 mg of darunavir boosted with 100 mg ritonavir once daily could show equivalent efficacy to continuation of ritonavir-boosted lopinavir (a protease inhibitor commonly used in low-income and middle-income countries) for individuals with HIV RNA suppression.
METHODS


In the WRHI 052 study, a randomised, parallel-group, open-label, non-inferiority phase 3 trial, adults who were HIV-1 positive were enrolled in Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, South Africa. Eligible participants were 18 years or older, who tolerated ritonavir-boosted lopinavir in combination with two nucleoside analogues (standard of care) for 6 months or more, and had plasma HIV-1 RNA of less than 50 copies per mL within 60 days of enrolment. We randomly assigned participants (1:1), using a computer-generated randomisation plan, to switch to darunavir (400 mg) boosted with ritonavir (100 mg) once daily or remain on ritonavir-boosted lopinavir (800 mg [plus 200 mg ritonavir]), with nucleoside analogues left unchanged. The primary endpoint was the proportion of patients with less than 50 HIV-1 RNA copies per mL at week 48 (US Food and Drug Administration snapshot algorithm; non-inferiority margin -4%). Primary and safety analyses included participants receiving at least one dose of darunavir boosted with ritonavir. This trial is registered with ClinicalTrials.gov, number NCT02671383.
FINDINGS


Between June 30, 2016, and June 15, 2017, 148 participants were assigned to ritonavir-boosted darunavir 400 mg and 152 continued on their lopinavir-containing regimen. Four (3%) patients in the darunavir group and three (2%) in the lopinavir group discontinued before week 48. At week 48, darunavir was non-inferior to lopinavir for the primary outcome (142 [96%] of 148 participants on darunavir had <50 HIV-1 RNA copies per mL vs 143 [94%] of 152 participants on lopinavir; difference 1·9% [95% CI -3·4 to 7·3]), with a predefined margin of -4%. More participants taking darunavir (30 [20%] participants) had drug-related adverse events than those on lopinavir (eight [5%]), but the adverse events were generally asymptomatic and resolved when switching back to lopinavir. Elevated liver transaminase in three (1%; one symptomatic) darunavir participants led to study withdrawal; all transaminase elevations resolved on restarting lopinavir.
INTERPRETATION


Low-dose ritonavir-boosted darunavir might be a safe and efficacious switch option to maintain HIV suppression for patients on lopinavir. However, an adequately powered and designed study in viraemic participants is needed.
FUNDING


South African Medical Research Council, United States Agency for International Development, and US National Institute of Allergy and Infectious Diseases.",2019,"At week 48, darunavir was non-inferior to lopinavir for the primary outcome (142 [96%] of 148 participants on darunavir had <50 HIV-1 RNA copies per mL vs 143 [94%] of 152 participants on lopinavir; difference 1·9% [95% CI -3·4 to 7·3]), with a predefined margin of -4%.","['Eligible participants were 18 years or older, who tolerated ritonavir-boosted lopinavir in combination with two nucleoside analogues (standard of care) for 6 months or more, and had plasma HIV-1 RNA of less than 50 copies per mL within 60 days of enrolment', 'viraemic participants', 'Between June 30, 2016, and June 15, 2017', '148 participants were assigned to', 'participants with less than 50 HIV RNA copies per mL (WRHI 052', 'adults who were HIV-1 positive were enrolled in Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, South Africa', 'low-income and middle-income countries) for individuals with HIV RNA suppression', 'participants receiving at least one dose of darunavir boosted with']","['lopinavir', 'ritonavir-boosted lopinavir', 'ritonavir', 'Low-dose ritonavir-boosted darunavir once daily versus ritonavir-boosted lopinavir', 'darunavir (400 mg) boosted with ritonavir (100 mg) once daily or remain on ritonavir-boosted lopinavir (800 mg [plus 200 mg ritonavir', 'ritonavir-boosted darunavir']","['Elevated liver transaminase', 'adverse events', 'drug-related adverse events', 'proportion of patients with less than 50 HIV-1 RNA']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C1579410', 'cui_str': 'Nucleoside Analogs'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}]","[{'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]",148.0,0.437795,"At week 48, darunavir was non-inferior to lopinavir for the primary outcome (142 [96%] of 148 participants on darunavir had <50 HIV-1 RNA copies per mL vs 143 [94%] of 152 participants on lopinavir; difference 1·9% [95% CI -3·4 to 7·3]), with a predefined margin of -4%.","[{'ForeName': 'Willem D F', 'Initials': 'WDF', 'LastName': 'Venter', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: fventer@wrhi.ac.za.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Moorhouse', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Simiso', 'Initials': 'S', 'LastName': 'Sokhela', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Celicia', 'Initials': 'C', 'LastName': 'Serenata', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Godspower', 'Initials': 'G', 'LastName': 'Akpomiemie', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ambar', 'Initials': 'A', 'LastName': 'Qavi', 'Affiliation': 'Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Nonkululeko', 'Initials': 'N', 'LastName': 'Mashabane', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Arulappan', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Joel W', 'Initials': 'JW', 'LastName': 'Sim', 'Affiliation': 'Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Phumla Z', 'Initials': 'PZ', 'LastName': 'Sinxadi', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Lubbe', 'Initials': 'L', 'LastName': 'Wiesner', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Ellisha', 'Initials': 'E', 'LastName': 'Maharaj', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Wallis', 'Affiliation': 'BARC, Lancet Laboratories, Johannesburg, South Africa.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Boyles', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ripin', 'Affiliation': 'Clinton Health Access Initiative, Boston, MA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Stacey', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Division of Infectious Diseases, Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Gila', 'Initials': 'G', 'LastName': 'Chitauri', 'Affiliation': 'Division of Infectious Diseases, Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.'}]",The lancet. HIV,['10.1016/S2352-3018(19)30081-5']
947,31823111,"The Feasibility, Acceptability and Preliminary Impact of Mobile Application to Increase Repeat HIV Testing Among Sexual Minority Men.","We pilot tested the Status Update Project (SUP) mobile app intervention to promote repeat HIV testing among HIV-negative US MSM. Participants (Mean age = 29 years; 51% racial/ethnic minority; 63% single) who were eligible and enrolled were randomized to either the SUP mobile app or a no-treatment condition, with assessments at baseline and month 4 and 8. Eighty-three percent of men were retained at the 8-month follow up. Among men randomized to the SUP arm, the app's ease and simplicity, health information, HIV testing locator, and HIV test reminders were most liked. At month 4, men randomized to the SUP arm were more likely to be repeat testers compared to those in the control arm (RR = 4.4; 95% CI 0.9, 19.9), although differences diminished by month 8 (RR = 1.2; 95% CI 0.8, 2.0). These findings add to our understanding of how mHealth interventions may play an important role in encouraging repeat HIV testing among MSM.",2020,"Among men randomized to the SUP arm, the app's ease and simplicity, health information, HIV testing locator, and HIV test reminders were most liked.","['Sexual Minority Men', 'Eighty-three percent of men were retained at the 8-month follow up', '29\xa0years; 51% racial/ethnic minority; 63% single) who were eligible and enrolled', 'Participants (Mean age\u2009']","['SUP', 'Mobile Application', 'SUP mobile app or a no-treatment condition', 'Status Update Project (SUP) mobile app intervention']",[],"[{'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0374778,"Among men randomized to the SUP arm, the app's ease and simplicity, health information, HIV testing locator, and HIV test reminders were most liked.","[{'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Horvath', 'Affiliation': 'SDSU/UCSD Joint Doctoral Program in Clinical Psychology, Department of Psychology, San Diego State University, 6363 Alvarado Court, San Diego, CA, 92120, USA. khorvath@sdsu.edu.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lammert', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Thu', 'Initials': 'T', 'LastName': 'Danh', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Jason W', 'Initials': 'JW', 'LastName': 'Mitchell', 'Affiliation': ""Office of Public Health Studies, University of Hawai'i at Mānoa, Honolulu, HI, USA.""}]",AIDS and behavior,['10.1007/s10461-019-02755-7']
948,32409917,Evaluation of FOLFOX or CAPOX reintroduction with or without bevacizumab in relapsed colorectal cancer patients treated with oxaliplatin as adjuvant chemotherapy (REACT study).,"BACKGROUND


Chemotherapy in relapsed colorectal cancer patients treated with oxaliplatin as adjuvant chemotherapy is under debate. REACT study aimed to investigate the efficacy of reintroducing modified FOLFOX6 (mFOLFOX6) or CAPOX with or without bevacizumab in recurrent colorectal cancer patients after oxaliplatin adjuvant chemotherapy.
METHODS


Patients that participated in this trial had a medical history of adjuvant chemotherapy, including oxaliplatin with a cumulative dose greater than 400 mg/m 2 , and recurrence that was diagnosed more six months post adjuvant chemotherapy. Primary endpoints were response rate (RR) and disease control rate (DCR), while key secondary endpoints were time to treatment failure (TTF), progression-free survival (PFS), overall survival (OS), and safety.
RESULTS


A total of 31 patients were enrolled between October 2012 and October 2016. Of the 29 eligible patients, 7 received mFOLFOX6 and 22 received CAPOX. The RR was 62.1% (95% confidence interval 42.3-79.3) and the DCR was 82.8% (95% confidence interval 64.2-94.2). The RR for oxaliplatin-free interval was 100.0% in months 6-12 and 56.0% after 12 months. Median TTF, PFS, and OS were 6.3, 10.8, and 28.7 months, respectively. Grade 3 or worse peripheral sensory neuropathy developed in 6.5%. Allergic reactions occurred in 12.9% of the patients, with one (3.2%) grade 3 episode. There were no other severe treatment-related adverse events.
CONCLUSION


Reintroduction of oxaliplatin was feasible and achieved high RR or DCR in patients after more than 6 months post oxaliplatin adjuvant chemotherapy.",2020,Reintroduction of oxaliplatin was feasible and achieved high RR or DCR in patients after more than 6 months post oxaliplatin adjuvant chemotherapy.,"['31 patients were enrolled between October 2012 and October 2016', 'relapsed colorectal cancer patients treated with', '29 eligible patients, 7 received mFOLFOX6 and 22 received', 'recurrent colorectal cancer patients after oxaliplatin adjuvant chemotherapy', 'Patients that participated in this trial had a medical history of adjuvant chemotherapy, including oxaliplatin with a cumulative dose greater than 400\xa0mg/m 2 , and recurrence that was diagnosed more six months post adjuvant chemotherapy']","['oxaliplatin', 'reintroducing modified FOLFOX6 (mFOLFOX6) or CAPOX with or without bevacizumab', 'oxaliplatin adjuvant chemotherapy', 'FOLFOX or CAPOX reintroduction with or without bevacizumab', 'CAPOX']","['RR for oxaliplatin-free interval', 'time to treatment failure (TTF), progression-free survival (PFS), overall survival (OS), and safety', 'Median TTF, PFS, and OS', 'Allergic reactions', 'Grade 3 or worse peripheral sensory neuropathy', 'response rate (RR) and disease control rate (DCR', 'severe treatment-related adverse events', 'DCR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0854750', 'cui_str': 'Colorectal cancer recurrent'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",31.0,0.339237,Reintroduction of oxaliplatin was feasible and achieved high RR or DCR in patients after more than 6 months post oxaliplatin adjuvant chemotherapy.,"[{'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Kotaka', 'Affiliation': 'Gastrointestinal Cancer Center, Sano Hospital, 2-5-1, Shimizugaoka, Tarumi-ku, Kobe, 655-0031, Japan. tomomakotaka6410@yahoo.co.jp.'}, {'ForeName': 'Shigeyoshi', 'Initials': 'S', 'LastName': 'Iwamoto', 'Affiliation': 'Cancer Center, Aichi Medical University, Aichi, Japan.'}, {'ForeName': 'Hironaga', 'Initials': 'H', 'LastName': 'Satake', 'Affiliation': 'Cancer Treatment Center, Kansai Medical University Hospital, Osaka, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sakai', 'Affiliation': 'Department of Frontier Science for Cancer and Chemotherapy, Graduate School of Medicine, Osaka University, Osaka, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Kudo', 'Affiliation': 'Department of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Mutsumi', 'Initials': 'M', 'LastName': 'Fukunaga', 'Affiliation': 'Department of Surgery, Hyogo Prefectural Nishinomiya Hospital, Hyogo, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Konishi', 'Affiliation': 'Department of Surgery, Hyogo Prefectural Nishinomiya Hospital, Hyogo, Japan.'}, {'ForeName': 'Yoshihito', 'Initials': 'Y', 'LastName': 'Ide', 'Affiliation': 'Department of Surgery, Yao Municipal Hospital, Osaka, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Ikumoto', 'Affiliation': 'Gastrointestinal Cancer Center, Sano Hospital, 2-5-1, Shimizugaoka, Tarumi-ku, Kobe, 655-0031, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Tsuji', 'Affiliation': 'Department of Clinical Oncology, Faculty of Medicine, Kagawa University, Kagawa, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Sano', 'Affiliation': 'Gastrointestinal Center, Sano Hospital, Hyogo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Surgery, National Hospital Organization, Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Naotoshi', 'Initials': 'N', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Taroh', 'Initials': 'T', 'LastName': 'Satoh', 'Affiliation': 'Department of Frontier Science for Cancer and Chemotherapy, Graduate School of Medicine, Osaka University, Osaka, Japan.'}, {'ForeName': 'Akiyoshi', 'Initials': 'A', 'LastName': 'Kanazawa', 'Affiliation': 'Department of Surgery, Shimane Prefectural Central Hospital, Shimane, Japan.'}, {'ForeName': 'Takayasu', 'Initials': 'T', 'LastName': 'Kurata', 'Affiliation': 'Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Tomita', 'Affiliation': 'Division of Lower GI Surgery, Department of Surgery, Hyogo College of Medicine, Hyogo, Japan.'}]",International journal of clinical oncology,['10.1007/s10147-020-01701-1']
949,32406798,Can hippotherapy make a difference in the quality of life of children with cerebral palsy? A pragmatic study.,"Objective : To determine if the addition of 12 weekly therapy sessions, incorporating hippotherapy as the primary intervention to each child's usual therapy program, will improve balance, participation, and quality of life. Methods : Pragmatic, multi-center, randomized, controlled trial of 13 children with cerebral palsy (CP), ages 3 to 6 years. A treatment group received 12 weeks of weekly hippotherapy intervention in addition to their usual therapy. A control group continued with their usual therapy only. Assessments were completed for the treatment group pre-intervention (P0), post intervention (P1), and 12 weeks post no intervention (P2). Control group assessments occurred in the same timeframe: baseline, 12 weeks and 24 weeks. Results : The only significant difference between the groups, post intervention, was on the Pediatric Balance Scale (PBS). Within group analysis showed no significant changes for the control group between any pretest/posttest measures. The treatment group demonstrated significant improvement on the PBS (P0-P1,  p  = .02; P0-P2,  p  = .02) and Activities Scale for Kids (P0-P1,  p  = .02; P0-P2,  p  = .02) with delayed improvement on the 1 Minute Walk Test (P1-P2,  p  = .02) and Pediatric Quality of Life - CP Module (P0-P2,  p  = .03). Conclusions : Improvements in balance in children with CP may promote increased participation and quality of life when hippotherapy is added to their treatment plan.",2020,"The treatment group demonstrated significant improvement on the PBS (P0-P1,  p  = .02; P0-P2,  p  = .02) and Activities Scale for Kids (P0-P1,  p  = .02; P0-P2,  p  = .02) with delayed improvement on the 1 Minute Walk Test (P1-P2,  p  = .02) and Pediatric Quality of Life - CP Module (P0-P2,  p  = .03).","['13 children with cerebral palsy (CP), ages 3 to 6\xa0years', 'children with CP', 'children with cerebral palsy']","['hippotherapy intervention', 'intervention (P0), post intervention (P1), and 12\xa0weeks post no intervention (P2']","['quality of life', 'PBS', 'participation and quality of life', 'balance, participation, and quality of life', 'Activities Scale', 'Pediatric Quality of Life - CP Module', 'Pediatric Balance Scale (PBS']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0454416', 'cui_str': 'Hippotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C3542953', 'cui_str': 'Module'}]",13.0,0.0229906,"The treatment group demonstrated significant improvement on the PBS (P0-P1,  p  = .02; P0-P2,  p  = .02) and Activities Scale for Kids (P0-P1,  p  = .02; P0-P2,  p  = .02) with delayed improvement on the 1 Minute Walk Test (P1-P2,  p  = .02) and Pediatric Quality of Life - CP Module (P0-P2,  p  = .03).","[{'ForeName': 'Debbie J', 'Initials': 'DJ', 'LastName': 'Silkwood-Sherer', 'Affiliation': 'Doctoral Program in Physical Therapy, Central Michigan University, Mt. Pleasant, MI, USA.'}, {'ForeName': 'Nancy H', 'Initials': 'NH', 'LastName': 'McGibbon', 'Affiliation': 'Therapeutic Riding of Tucson (TROT), Therapy Clinic, TROT Therapy Services, Tucson, AZ, USA.'}]",Physiotherapy theory and practice,['10.1080/09593985.2020.1759167']
950,31272592,"Continuous Positive Airway Pressure Therapy Restores Cardiac Mechanical Function in Patients With Severe Obstructive Sleep Apnea: A Randomized, Sham-Controlled Study.","BACKGROUND


Continuous positive airway pressure (CPAP) therapy might decrease left ventricular (LV) and right ventricular (RV) loads and improve cardiac mechanical function in patients with obstructive sleep apnea (OSA). However, the benefits of CPAP therapy for cardiac mechanical function in patients with OSA have not previously been proved in a randomized, sham-controlled clinical trial. This study therefore investigated the effects of CPAP therapy on LV and RV mechanical function in patients with severe OSA and compared them with the effects of a sham intervention.
METHODS


In this randomized sham-controlled trial, we analyzed LV and RV function by conventional and speckle-tracking echocardiography before and after 3 months of treatment in 52 patients with severe OSA. Patients were randomly assigned (1:1) to receive either CPAP or sham treatment for 3 months. The main investigator and patients were masked to the trial randomization.
RESULTS


After 3 months, CPAP treatment significantly improved LV global longitudinal strain (GLS) compared with the sham treatment (-20.0% ± 2.1% vs -18.0% ± 2.5%; P = .004), although there were no differences in LV dimension or ejection fraction. CPAP treatment reduced RV size and improved the fractional area change (51.3% ± 7.9% vs 46.9% ± 6.7%; P = .038) compared with the sham treatment. CPAP treatment did not ameliorate the RV GLS compared with the sham treatment.
CONCLUSIONS


In patients with severe OSA, CPAP treatment for 3 months improved LV and RV function compared with sham treatment. LV mechanical function assessed by speckle-tracking echocardiography and RV fractional area change assessed by two-dimensional echocardiography were significantly improved by CPAP treatment.",2019,CPAP treatment reduced RV size and improved the fractional area change (51.3% ± 7.9% vs 46.9% ± 6.7%; P = .038) compared with the sham treatment.,"['52 patients with severe OSA', 'Patients With Severe Obstructive Sleep Apnea', 'patients with severe OSA', 'patients with obstructive sleep apnea (OSA', 'patients with OSA']","['CPAP therapy', 'Continuous positive airway pressure (CPAP) therapy', 'conventional and speckle-tracking echocardiography', 'Continuous Positive Airway Pressure Therapy Restores Cardiac Mechanical Function', 'CPAP']","['RV size', 'left ventricular (LV) and right ventricular (RV) loads', 'RV GLS', 'cardiac mechanical function', 'LV and RV mechanical function', 'LV mechanical function assessed by speckle-tracking echocardiography and RV fractional area change', 'LV dimension or ejection fraction', 'fractional area change', 'LV and RV function', 'LV global longitudinal strain (GLS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439691', 'cui_str': 'Speckled (qualifier value)'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]","[{'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439691', 'cui_str': 'Speckled (qualifier value)'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}]",52.0,0.117563,CPAP treatment reduced RV size and improved the fractional area change (51.3% ± 7.9% vs 46.9% ± 6.7%; P = .038) compared with the sham treatment.,"[{'ForeName': 'Darae', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Chi Young', 'Initials': 'CY', 'LastName': 'Shim', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yang-Je', 'Initials': 'YJ', 'LastName': 'Cho', 'Affiliation': 'Department of Neurology, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sungha', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Chan Joo', 'Initials': 'CJ', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Joo Hee', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyoung Joo', 'Initials': 'HJ', 'LastName': 'Cho', 'Affiliation': 'Department of Otorhinolaryngology, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jong-Won', 'Initials': 'JW', 'LastName': 'Ha', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Geu-Ru', 'Initials': 'GR', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: grhong@yuhs.ac.'}]",Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography,['10.1016/j.echo.2019.03.020']
951,30929973,Does prior coronary angioplasty affect outcomes of surgical coronary revascularization? Insights from the STICH trial.,"BACKGROUND


The STICH trial showed superiority of coronary artery bypass plus medical treatment (CABG) over medical treatment alone (MED) in patients with left ventricular ejection fraction (LVEF) ≤35%. In previous publications, percutaneous coronary intervention (PCI) prior to CABG was associated with worse prognosis.
OBJECTIVES


The main purpose of this study was to analyse if prior PCI influenced outcomes in STICH.
METHODS AND RESULTS


Patients in the STICH trial (n = 1212), followed for a median time of 9.8 years, were included in the present analyses. In the total population, 156 had a prior PCI (74 and 82, respectively, in the MED and CABG groups). In those with vs. without prior PCI, the adjusted hazard-ratios (aHRs) were 0.92 (95% CI = 0.74-1.15) for all-cause mortality, 0.85 (95% CI = 0.64-1.11) for CV mortality, and 1.43 (95% CI = 1.15-1.77) for CV hospitalization. In the group randomized to CABG without prior PCI, the aHRs were 0.82 (95% CI = 0.70-0.95) for all-cause mortality, 0.75 (95% CI = 0.62-0.90) for CV mortality and 0.67 (95% CI = 0.56-0.80) for CV hospitalization. In the group randomized to CABG with prior PCI, the aHRs were 0.76 (95% CI = 0.50-1.15) for all-cause mortality, 0.81 (95% CI = 0.49-1.36) for CV mortality and 0.61 (95% CI = 0.41-0.90) for CV hospitalization. There was no evidence of interaction between randomized treatment and prior PCI for any endpoint (all adjusted p > 0.05).
CONCLUSION


In the STICH trial, prior PCI did not affect the outcomes of patients whether they were treated medically or surgically, and the superiority of CABG over MED remained unchanged regardless of prior PCI.
CLINICAL TRIAL REGISTRATION


Clinicaltrials.gov; Identifier: NCT00023595.",2019,"There was no evidence of interaction between randomized treatment and prior PCI for any endpoint (all adjusted p > 0.05).
","['patients with left ventricular ejection fraction (LVEF) ≤35', 'Patients in the STICH trial (n\u202f=\u202f1212), followed for a median time of 9.8\u202fyears, were included in the present analyses']","['CABG', 'coronary artery bypass plus medical treatment (CABG']","['adjusted hazard-ratios (aHRs', 'CV mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.177077,"There was no evidence of interaction between randomized treatment and prior PCI for any endpoint (all adjusted p > 0.05).
","[{'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil. Electronic address: jose.nicolau@incor.usp.br.'}, {'ForeName': 'Susanna R', 'Initials': 'SR', 'LastName': 'Stevens', 'Affiliation': 'Duke Clinical Research Institute and Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Hussein R', 'Initials': 'HR', 'LastName': 'Al-Khalidi', 'Affiliation': 'Duke Clinical Research Institute and Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Fabio B', 'Initials': 'FB', 'LastName': 'Jatene', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Remo H M', 'Initials': 'RHM', 'LastName': 'Furtado', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Luis A O', 'Initials': 'LAO', 'LastName': 'Dallan', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Luiz A F', 'Initials': 'LAF', 'LastName': 'Lisboa', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Haissam', 'Initials': 'H', 'LastName': 'Haddad', 'Affiliation': 'Department of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'E Marc', 'Initials': 'EM', 'LastName': 'Jolicoeur', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, Quebec, Canada.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Doenst', 'Affiliation': 'Department of Cardiothoracic Surgery, University of Jena, Jena, Germany.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Michler', 'Affiliation': 'Department of Cardiothoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY, USA.'}, {'ForeName': 'E Magnus', 'Initials': 'EM', 'LastName': 'Ohman', 'Affiliation': 'Duke Clinical Research Institute and Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Jyotsna', 'Initials': 'J', 'LastName': 'Maddury', 'Affiliation': 'Department of Cardiology, Nizams Institute of Medical Sciences, Hyderabad, India.'}, {'ForeName': 'Imtiaz', 'Initials': 'I', 'LastName': 'Ali', 'Affiliation': 'Libin Cardiovascular Institute of Alberta, University of Calgary, Foothills Medical Centre, Calgary, Alberta, Canada.'}, {'ForeName': 'Marek A', 'Initials': 'MA', 'LastName': 'Deja', 'Affiliation': 'Department of Cardiac Surgery, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Jean L', 'Initials': 'JL', 'LastName': 'Rouleau', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, Quebec, Canada.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Velazquez', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Hill', 'Affiliation': 'Department of Medicine, University of Florida, Gainesville, FL, USA.'}]",International journal of cardiology,['10.1016/j.ijcard.2019.03.029']
952,32409838,Study on the prevention of infection in terminal cancer patients applying epidural analgesia by adding cefazolin to anesthetics: a randomized controlled trial.,"OBJECTIVE


To observe the antibacterial effect of adding cefazolin into anesthetics in patients with terminal cancer undergoing long-term epidural analgesia.
METHODS


Patients undergoing epidural analgesia with terminal cancer were randomly divided into two groups: the conventional drug group (group C) and the cefazolin group (group G). Both groups were given levobupivacaine and morphine, while cefazolin was added to group G. The mean arterial pressure (MAP), heart rate (HR), respiratory rates (R), visual analogue scale (VAS) scores, satisfaction and complications of patients in the two groups were observed. 3 ml of the used analgesic was taken for bacterial culture when replacing the new analgesic case.
RESULTS


HR, MAP, R, VAS scores, dosages of morphine, satisfaction of the analgesic and the complications were not significantly different between the two groups (P > 0.05). The overall satisfaction of patients in group G was significantly higher than that in group C (P < 0.05). One patient's anesthetics in group C were infected with colibacillus. Four patients in group C got infected in their epidural puncture sites. There was no infection in group G (P < 0.05).
CONCLUSION


Adding cefazolin to local anesthetics could effectively prevent bacterial infection and ensured the safety of epidural analgesia for patients with terminal cancer.",2020,"VAS scores, dosages of morphine, satisfaction of the analgesic and the complications were not significantly different between the two groups (P > 0.05).","['terminal cancer patients applying', 'Patients undergoing epidural analgesia with terminal cancer', 'patients with terminal cancer undergoing long-term epidural analgesia', 'patients with terminal cancer']","['cefazolin to anesthetics', 'cefazolin into anesthetics', 'epidural analgesia', 'cefazolin', 'levobupivacaine and morphine, while cefazolin']","['mean arterial pressure (MAP), heart rate (HR), respiratory rates (R), visual analogue scale (VAS) scores, satisfaction and complications', 'overall satisfaction', 'VAS scores, dosages of morphine, satisfaction of the analgesic and the complications']","[{'cui': 'C0741884', 'cui_str': 'End stage cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0007546', 'cui_str': 'Cefazolin'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",4.0,0.0318469,"VAS scores, dosages of morphine, satisfaction of the analgesic and the complications were not significantly different between the two groups (P > 0.05).","[{'ForeName': 'Pengcheng', 'Initials': 'P', 'LastName': 'Xie', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Pudong, Shanghai, China.'}, {'ForeName': 'Zhanfang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Pudong, Shanghai, China.'}, {'ForeName': 'Jingli', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Pudong, Shanghai, China.'}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Pudong, Shanghai, China.'}]",Japanese journal of clinical oncology,['10.1093/jjco/hyaa060']
953,32409903,"A commentary on ""Benefit of a nurse-led telephone-based intervention prior to the first urogynecology outpatient visit: a randomized-controlled trial"".",,2020,,[],['nurse-led telephone-based intervention'],[],[],"[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0597638,,"[{'ForeName': 'Dominique Malacarne', 'Initials': 'DM', 'LastName': 'Pape', 'Affiliation': 'NYU Langone Health, New York, NY, USA. Dominique.Malacarne@nyulangone.org.'}]",International urogynecology journal,['10.1007/s00192-020-04327-z']
954,32409944,"Evidence for improved survival with bevacizumab treatment in recurrent high-grade gliomas: a retrospective study with (""pseudo-randomized"") treatment allocation by the health insurance provider.","INTRODUCTION


Despite a large number of trials, the role of bevacizumab (BEV) in the treatment of recurrent high-grade gliomas is still controversial. Evidence regarding an effect on overall survival in this context is ultimately inconclusive. At the Department of Radiation Oncology at Erlangen, Germany we treated a large cohort of patients with recurrent gliomas where bevacizumab use was determined exclusively by the health care provider's approval of reimbursement.
METHODS


61 patients (between 06/2008 and 01/2014) with recurrent high-grade gliomas had reimbursement requests for BEV sent to their health insurance. 37 patients out of 61 (60.7%) had their requests approved and therefore received bevacizumab (BEV-arm) as part of their treatment. The remaining 24 (39.3%) patients received standard therapy without bevacizumab (non-BEV-arm). Survival endpoints were defined with reference to the first BEV request to the health insurance provider.
RESULTS


Median overall survival (OS) for the whole cohort was 7.0 months. OS was significantly better for BEV vs. Non-BEV patients (median, 10.3 vs. 4.2 months, logrank p = 0.023). There was an increased BEV benefit in cases of higher-order recurrences (first order recurrence BEV vs. Non-BEV, 12.5 vs. 10.2 months, p = 0.578) (second or higher order of recurrence, 9.9 vs. 2.6 months, p = 0.010). On multivariate analysis for overall survival the prognostic impact of bevacizumab (HR = 0.43, p = 0.034) remained significant.
CONCLUSION


Our results suggest an influence of BEV on overall survival in a heavily pretreated patient population suffering from high-grade gliomas with BEV benefit being greatest in case of second or later recurrence.",2020,"On multivariate analysis for overall survival the prognostic impact of bevacizumab (HR = 0.43, p = 0.034) remained significant.
","['recurrent high-grade gliomas', '61 patients (between 06/2008 and 01/2014) with recurrent high-grade gliomas had reimbursement requests for BEV sent to their health insurance', '37 patients out of 61 (60.7%) had their requests approved and therefore received']","['standard therapy without bevacizumab', 'bevacizumab (BEV', 'bevacizumab']","['OS', 'overall survival', 'survival', 'Median overall survival (OS', 'BEV benefit', 'Survival endpoints']","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0555198', 'cui_str': 'Glioma, malignant, no ICD-O subtype'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]",61.0,0.0806815,"On multivariate analysis for overall survival the prognostic impact of bevacizumab (HR = 0.43, p = 0.034) remained significant.
","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Hofmann', 'Affiliation': 'Department of Radiotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitaetsstraße 27, 91054, Erlangen, Germany.'}, {'ForeName': 'Manuel Alexander', 'Initials': 'MA', 'LastName': 'Schmidt', 'Affiliation': 'Department of Neuroradiology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Schwabachanlage 6, 91054, Erlangen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Weissmann', 'Affiliation': 'Department of Radiotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitaetsstraße 27, 91054, Erlangen, Germany.'}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Eyüpoglu', 'Affiliation': 'Department of Neurosurgery, Friedrich-Alexander-Universität Erlangen-Nürnberg, Schwabachanlage 6, 91054, Erlangen, Germany.'}, {'ForeName': 'Annedore', 'Initials': 'A', 'LastName': 'Strnad', 'Affiliation': 'Department of Radiotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitaetsstraße 27, 91054, Erlangen, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Semrau', 'Affiliation': 'Department of Radiotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitaetsstraße 27, 91054, Erlangen, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Fietkau', 'Affiliation': 'Department of Radiotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitaetsstraße 27, 91054, Erlangen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Putz', 'Affiliation': 'Department of Radiotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitaetsstraße 27, 91054, Erlangen, Germany. florian.putz@uk-erlangen.de.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Lettmaier', 'Affiliation': 'Department of Radiotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitaetsstraße 27, 91054, Erlangen, Germany.'}]",Journal of neuro-oncology,['10.1007/s11060-020-03533-5']
955,31801937,Effects of intranasal oxytocin administration on empathy and approach motivation in women with borderline personality disorder: a randomized controlled trial.,"Borderline personality disorder (BPD) is characterized by severe interpersonal dysfunction with problems in social cognition, empathy and social approach. Although the neuropeptide oxytocin is known to regulate complex social cognition and behavior in healthy individuals and clinical populations, there is still a lack of evidence for a potential beneficial effect of oxytocin administration on social cognition and social approach in BPD. Fifty-one women with BPD and 51 matched healthy controls were randomized to a double-blind, placebo-controlled, between-subject experimental trial. We administered a single dose of 24 IU oxytocin or placebo intranasally prior to a standardized task measuring affective and cognitive empathy and approach motivation. All participants were free of hormonal contraception and tested in the mid-luteal phase of their menstrual cycle. In the placebo condition, patients with BPD showed reduced cognitive and affective empathy, and less approach behavior motivation than healthy controls. Intranasal oxytocin significantly increased affective empathy and approach motivation in both BPD patients and healthy controls compared to placebo. More importantly, oxytocin administration led to similar scores between BPD and healthy controls. These findings provide the first evidence for a beneficial effect of oxytocin on deficits in affective empathy and approach motivation of BPD. Our results indicate a beneficial effect of a single dose of oxytocin on affective empathy and approach motivation in women with BPD adapting their level of social functioning to healthy controls. Future clinical trials will need to investigate the long-term effects and effectiveness of oxytocin as an add-on treatment for social impairments in BPD.",2019,"In the placebo condition, patients with BPD showed reduced cognitive and affective empathy, and less approach behavior motivation than healthy controls.","['women with BPD adapting their level of social functioning to healthy controls', 'Fifty-one women with BPD and 51 matched healthy controls', 'healthy individuals and clinical populations', 'Borderline personality disorder (BPD', 'women with borderline personality disorder', 'All participants were free of hormonal contraception and tested in the mid-luteal phase of their menstrual cycle']","['oxytocin', 'placebo', 'Intranasal oxytocin', 'neuropeptide oxytocin', 'intranasal oxytocin', 'oxytocin or placebo']","['reduced cognitive and affective empathy', 'approach behavior motivation', 'affective empathy and approach motivation', 'empathy and approach motivation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C2985296', 'cui_str': 'Hormonal contraception'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0024153', 'cui_str': 'Postovulatory Phase'}, {'cui': 'C4553712', 'cui_str': 'Onset of menstrual cycle'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptides'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C4046027', 'cui_str': 'Approach Behavior'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]",51.0,0.175967,"In the placebo condition, patients with BPD showed reduced cognitive and affective empathy, and less approach behavior motivation than healthy controls.","[{'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Domes', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, Freiburg, Germany. domes@uni-trier.de.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ower', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'von Dawans', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Franny B', 'Initials': 'FB', 'LastName': 'Spengler', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Dziobek', 'Affiliation': 'Department of Psychology, Clinical Psychology of Social Interaction, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bohus', 'Affiliation': 'Institute of Psychosomatic and Psychiatric Psychotherapy, Central Institute of Mental Health, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Swantje', 'Initials': 'S', 'LastName': 'Matthies', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Philipsen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heinrichs', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, Freiburg, Germany. heinrichs@psychologie.uni-freiburg.de.'}]",Translational psychiatry,['10.1038/s41398-019-0658-4']
956,31258108,Short-term impact of sucralose consumption on the metabolic response and gut microbiome of healthy adults.,"Sucralose is an artificial non-nutritive sweetener used in foods aimed to reduce sugar and energy intake. While thought to be inert, the impact of sucralose on metabolic control has shown to be the opposite. The gut microbiome has emerged as a factor shaping metabolic responses after sweetener consumption. We examined the short-term effect of sucralose consumption on glucose homeostasis and gut microbiome of healthy male volunteers. We performed a randomised, double-blind study in thirty-four subjects divided into two groups, one that was administered sucralose capsules (780 mg/d for 7 d; n 17) and a control group receiving placebo (n 17). Before and after the intervention, glycaemic and insulinaemic responses were assessed with a standard oral glucose load (75 g). Insulin resistance was determined using homeostasis model assessment of insulin resistance and Matsuda indexes. The gut microbiome was evaluated before and after the intervention by 16S rRNA sequencing. During the study, body weight remained constant in both groups. Glycaemic control and insulin resistance were not affected during the 7-d period. At the phylum level, gut microbiome was not modified in any group. We classified subjects according to their change in insulinaemia after the intervention, to compare the microbiome of responders and non-responders. Independent of consuming sucralose or placebo, individuals with a higher insulinaemic response after the intervention had lower Bacteroidetes and higher Firmicutes abundances. In conclusion, consumption of high doses of sucralose for 7 d does not alter glycaemic control, insulin resistance, or gut microbiome in healthy individuals. However, it highlights the need to address individual responses to sucralose.",2019,"Independent of consuming sucralose or placebo, individuals with a higher insulinemic response after the intervention had lower Bacteroidetes and higher Firmicutes abundances.","['34 subjects divided into two groups', 'healthy individuals', 'Healthy Adults', 'healthy male volunteers']","['placebo', 'control group receiving placebo', 'sucralose consumption', 'Sucralose Consumption', 'sucralose capsules']","['glycemic and insulinemic responses', 'Insulin resistance', 'Glycemic control and insulin resistance', 'glucose homeostasis', 'glycemic control, insulin resistance, or gut microbiome', 'Metabolic Response and Gut Microbiome']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0077046', 'cui_str': 'sucralose'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}]",34.0,0.0395037,"Independent of consuming sucralose or placebo, individuals with a higher insulinemic response after the intervention had lower Bacteroidetes and higher Firmicutes abundances.","[{'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Thomson', 'Affiliation': 'Department of Chemical and Bioprocess Engineering, School of Engineering, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Santibañez', 'Affiliation': 'Department of Chemical and Bioprocess Engineering, School of Engineering, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Aguirre', 'Affiliation': 'Departamento Ciencias de la Salud, Carrera de Nutrición y Dietética, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Jose E', 'Initials': 'JE', 'LastName': 'Galgani', 'Affiliation': 'Departamento Ciencias de la Salud, Carrera de Nutrición y Dietética, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Garrido', 'Affiliation': 'Department of Chemical and Bioprocess Engineering, School of Engineering, Pontificia Universidad Católica de Chile, Santiago, Chile.'}]",The British journal of nutrition,['10.1017/S0007114519001570']
957,31255591,Evaluation of integrated interventions layered on mass drug administration for urogenital schistosomiasis elimination: a cluster-randomised trial.,"BACKGROUND


Elimination of schistosomiasis as a public health problem and interruption of transmission in selected areas are targets set by WHO for 2025. Our aim was to assess biannual mass drug administration (MDA) applied alone or with complementary snail control or behaviour change interventions for the reduction of Schistosoma haematobium prevalence and infection intensity in children from Zanzibar and to compare the effect between the clusters.
METHODS


In a 5-year repeated cross-sectional cluster-randomised trial, 90 shehias (small administrative regions; clusters) in Zanzibar eligible owing to available natural open freshwater bodies and public primary schools were randomly allocated (ratio 1:1:1) to receive one of three interventions: biannual MDA with praziquantel alone (arm 1) or in combination with snail control (arm 2), or behaviour change activities (arm 3). Neither participants nor field or laboratory personnel were blinded to the intervention arms. From 2012 to 2017, annually, a single urine sample was collected from approximately 100 children aged 9-12 years in the main public primary school of each shehia. The primary outcome was S haematobium infection prevalence and intensity in 9-12-year-old children after 5 years of follow-up. This study is completed and was registered with the ISRCTN, number 48837681.
FINDINGS


The trial was done from Nov 1, 2011, through to Dec 31, 2017 and recruitment took place from Nov 2, 2011, until May 17, 2017. At baseline we enrolled 8278 participants, of whom 2899 (35%) were randomly allocated to arm 1, 2741 (33%) to arm 2, and 2638 (32%) to arm 3. 120 (4·2%) of 2853 in arm 1, 209 (7·8%) of 2688 in arm 2, and 167 (6·4%) of 2613 in arm 3 had S haematobium infections at baseline. Heavy infections (≥50 eggs per 10 mL of urine) were found in 126 (1·6%) of 8073 children at baseline. At the 5-year endline survey, 46 (1·4%) of 3184 in arm 1, 56 (1·7%) of 3217 (odds ratio [OR] 1·2 [95% CI 0·6-2·7] vs arm 1) in arm 2, and 58 (1·9%) of 3080 (1·3 [0·6-2·9]) in arm 3 had S haematobium infections. Heavy infections were detected in 33 (0·3%) of 9462 children.
INTERPRETATION


Biannual MDA substantially reduced the S haematobium prevalence and infection intensity but was insufficient to interrupt transmission. Although snail control or behaviour change activities did not significantly boost the effect of MDA in our study, they might enhance interruption of transmission when tailored to focal endemicity and applied for a longer period. It is now necessary to focus on reducing prevalence in remaining hotspot areas and to introduce new methods of surveillance and public health response so that the important gains can be maintained and advanced.
FUNDING


University of Georgia Research Foundation Inc and Bill & Melinda Gates Foundation.",2019,Heavy infections (≥50 eggs per 10 mL of urine) were found in 126 (1·6%) of 8073 children at baseline.,"['8278 participants, of whom 2899 (35', 'From 2012 to 2017, annually, a single urine sample was collected from approximately 100 children aged 9-12 years in the main public primary school of each shehia', '1·2', '90 shehias (small administrative regions; clusters) in Zanzibar eligible owing to available natural open freshwater bodies and public primary schools', 'urogenital schistosomiasis elimination', 'Neither participants nor field or laboratory personnel']","['biannual mass drug administration (MDA) applied alone or with complementary snail control or behaviour change interventions', 'biannual MDA with praziquantel alone (arm 1) or in combination with snail control (arm 2), or behaviour change activities']","['S haematobium infections', 'Heavy infections', 'Schistosoma haematobium prevalence and infection intensity', 'S haematobium infection prevalence and intensity']","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0205959', 'cui_str': 'Zanzibar'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0016710', 'cui_str': 'Freshwater'}, {'cui': 'C1704430', 'cui_str': 'Urinary Schistosomiasis'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C3178774', 'cui_str': 'Laboratory Personnel'}]","[{'cui': 'C4505223', 'cui_str': 'Mass Drug Administration'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C3853310', 'cui_str': 'Snail'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0036316', 'cui_str': 'Schistosoma haematobiums'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",8278.0,0.290061,Heavy infections (≥50 eggs per 10 mL of urine) were found in 126 (1·6%) of 8073 children at baseline.,"[{'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Knopp', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland; Wolfson Wellcome Biomedical Laboratories, Department of Life Sciences, Natural History Museum, London, UK. Electronic address: s.knopp@swisstph.ch.'}, {'ForeName': 'Bobbie', 'Initials': 'B', 'LastName': 'Person', 'Affiliation': 'Schistosomiasis Consortium for Operational Research and Evaluation, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Shaali M', 'Initials': 'SM', 'LastName': 'Ame', 'Affiliation': 'Public Health Laboratory-Ivo de Carneri, Pemba, Tanzania.'}, {'ForeName': 'Said M', 'Initials': 'SM', 'LastName': 'Ali', 'Affiliation': 'Public Health Laboratory-Ivo de Carneri, Pemba, Tanzania.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hattendorf', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Saleh', 'Initials': 'S', 'LastName': 'Juma', 'Affiliation': 'Public Health Laboratory-Ivo de Carneri, Pemba, Tanzania.'}, {'ForeName': 'Juma', 'Initials': 'J', 'LastName': 'Muhsin', 'Affiliation': 'Neglected Diseases Programme, Ministry of Health, Zanzibar, Tanzania.'}, {'ForeName': 'Iddi S', 'Initials': 'IS', 'LastName': 'Khamis', 'Affiliation': 'Neglected Diseases Programme, Ministry of Health, Zanzibar, Tanzania.'}, {'ForeName': 'Khalfan A', 'Initials': 'KA', 'LastName': 'Mohammed', 'Affiliation': 'Neglected Diseases Programme, Ministry of Health, Zanzibar, Tanzania.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Utzinger', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hollenberg', 'Affiliation': 'Schistosomiasis Control Initiative, Department of Infectious Disease Epidemiology, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Kabole', 'Affiliation': 'Neglected Diseases Programme, Ministry of Health, Zanzibar, Tanzania.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rollinson', 'Affiliation': 'Wolfson Wellcome Biomedical Laboratories, Department of Life Sciences, Natural History Museum, London, UK.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30189-5']
958,32409433,Antivirals for COVID-19.,"Drugs targeting RNA respiratory viruses has resulted in few effective therapies, highlighting challenges for antivirals to treat COVID-19. Several antivirals are being investigated for symptomatic COVID-19 but no definitive data support their clinical use. Remdesivir, with good in vitro activity against SARS-CoV2, appeared to result in favorable outcomes for hospitalized patients in a compassionate use series with shortened time to recovery and a modest decrease in mortality. Currently, remdesivir is available in phase III clinical trials, the compassionate use program, and eventually through the emergency use authorization. A randomized controlled trial of lopinavir/ritonavir demonstrated no apparent clinical or virologic benefit and drug-drug interactions and side effects further limit its utility. Antivirals to treat influenza (oseltamivir) have limited activity against SARS-CoV-2, but favipiravir and umifenovir, influenza antivirals available internationally, have distinct viral targets and require further investigation. Antivirals with evidence of clinical activity must be studied as treatment and prophylaxis for those at high risk for severe COVID-19.",2020,A randomized controlled trial of lopinavir/ritonavir demonstrated no apparent clinical or virologic benefit and drug-drug interactions and side effects further limit its utility.,[],"['lopinavir/ritonavir', 'influenza (oseltamivir']",['mortality'],[],"[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0487895,A randomized controlled trial of lopinavir/ritonavir demonstrated no apparent clinical or virologic benefit and drug-drug interactions and side effects further limit its utility.,"[{'ForeName': 'Pavithra', 'Initials': 'P', 'LastName': 'Srinivas', 'Affiliation': 'Inpatient Pharmacy, Cleveland Clinic.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Sacha', 'Affiliation': 'Inpatient Pharmacy, Cleveland Clinic.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Koval', 'Affiliation': 'Infectious Disease, Respiratory Institute, Cleveland Clinic.'}]",Cleveland Clinic journal of medicine,['10.3949/ccjm.87a.ccc030']
959,31250356,Broccoli sprout supplementation in patients with advanced pancreatic cancer is difficult despite positive effects-results from the POUDER pilot study.,"Pancreatic ductal adenocarcinoma is a highly aggressive malignancy with short survival and limited therapeutic options. Broccoli sulforaphane is a promising new treatment due to the results of recent epidemiological, experimental and patient studies. Upon approval from the ethics committee and registration at ClinicalTrials.gov, 40 patients with palliative chemotherapy were placed into a placebo and treatment group in an unblinded fashion. Fifteen capsules with pulverized broccoli sprouts containing 90 mg/508 μmol sulforaphane and 180 mg/411 μmol glucoraphanin or methylcellulose were administered daily for up to 1 year. Twenty-nine patients were included in the treatment group and 11 patients were in the placebo group; these patients were followed for up to 1 year. The patient characteristics, overall survival and feasibility were assessed. Compared to those of the placebo group, the mean death rate was lower in the treatment group during the first 6 months after intake (day 30: 0%/18%, day 90: 0%/25%, and day 180: 25%/43%), and Kaplan-Meier analysis revealed a higher survival rate. There was a high drop-out rate (72% in the treatment group and 55% in the placebo group) after 1 year. We concluded from the Karnofsky index that the broccoli sprouts did not impact patient's self-care and overall abilities severely. The intake of 15 capsules daily was difficult for some patients, and the broccoli sprouts sometimes increased digestive problems, nausea and emesis. We did not obtain statistically significant results (p = 0.291 for the endpoint at day 180), but the knowledge about the feasibility is the basis for the development of new sulforaphane drugs.",2020,There was a high drop-out rate (72% in the treatment group and 55% in the placebo group) after 1 year.,"['40 patients with palliative chemotherapy', 'Twenty-nine patients were included in the treatment group and 11 patients were in the', 'patients with advanced pancreatic cancer']","['Broccoli sprout supplementation', 'pulverized broccoli sprouts containing 90\xa0mg/508\xa0μmol sulforaphane and 180\xa0mg/411\xa0μmol glucoraphanin', 'Broccoli sulforaphane', 'placebo']","['mean death rate', 'digestive problems, nausea and emesis', 'survival rate', 'overall survival and feasibility']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}]","[{'cui': 'C0330499', 'cui_str': 'Broccoli'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0163159', 'cui_str': '4-methylsulphinylbutyl glucosinolate'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0768176', 'cui_str': 'beta-D-glucopyranose, 1-thio-, 1-(5-(methylsulfinyl)-N-(sulfooxy)pentanimidate)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",40.0,0.469328,There was a high drop-out rate (72% in the treatment group and 55% in the placebo group) after 1 year.,"[{'ForeName': 'Vladimir J', 'Initials': 'VJ', 'LastName': 'Lozanovski', 'Affiliation': 'Department of General, Visceral, and Transplant Surgery, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Polychronidis', 'Affiliation': 'Department of General, Visceral, and Transplant Surgery, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Gross', 'Affiliation': 'Department of General, Visceral, and Transplant Surgery, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Gharabaghi', 'Affiliation': 'Department of General, Visceral, and Transplant Surgery, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Arianeb', 'Initials': 'A', 'LastName': 'Mehrabi', 'Affiliation': 'Department of General, Visceral, and Transplant Surgery, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Hackert', 'Affiliation': 'Department of General, Visceral, and Transplant Surgery, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schemmer', 'Affiliation': 'Division of Transplant Surgery, Department of Surgery, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Herr', 'Affiliation': 'Department of General, Visceral, and Transplant Surgery, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany. i.herr@uni-heidelberg.de.'}]",Investigational new drugs,['10.1007/s10637-019-00826-z']
960,31262371,"Effects of  n -3 PUFA on endothelial function in patients with peripheral arterial disease: a randomised, placebo-controlled, double-blind trial.","As only limited evidence is available for potential benefits of n-3 PUFA supplementation in patients with peripheral arterial disease (PAD), we studied the effects of 4 g n-3 PUFA on endothelial function and inflammatory markers. Seventy patients with stable PAD classified as Rutherford stage 2 or 3 and good control of cardiovascular factors were randomised to receive either 4 g n-3 PUFA or placebo daily for 3 months in a double-blind fashion. Primary endpoint was endothelial function assessed by flow-mediated vasodilation (FMD). In addition, ankle-brachial index, maximum and pain-free walking distances were determined. Lipid parameters including the omega-3 index reflecting n-3 PUFA intake as well as pro-inflammatory, endothelial and platelet activation markers were measured over the same time interval. After 3 months of treatment with 4 g n-3 PUFA daily, a significant improvement of FMD was observed compared with placebo (n-3 PUFA, median Δ 3·7 (interquartile range (IQR) -1·8, 7·1) % v. placebo, Δ -0·5 (IQR -6·5, 3·0) %, P = 0·01 between the groups). After a 3-month washout period, this benefit was not sustained (n-3 PUFA, median Δ 0·6 (IQR -2·2, 5·6) % v. placebo, Δ -0·9 (IQR -6·6, 6·7) %, P = 0·20). In response to n-3 PUFA, an improvement of lipid parameters with a pronounced increase in the omega-3 index was seen. No changes were found for other parameters. In conclusion, in patients with PAD, 4 g/d n-3 PUFA improved cardiovascular risk in PAD patients, which needs testing in large-scale trials.",2019,"In response to n3-PUFA, an improvement of lipid parameters with a pronounced increase of omega-3 index was seen.","['Seventy patients with stable PAD classified as Rutherford stage 2 or 3 and good control of cardiovascular factors', 'patients with peripheral arterial disease (PAD', 'Patients with Peripheral Arterial Disease']","['N3-PUFA supplementation', 'n3-PUFA or placebo', 'placebo', 'Placebo', 'omega-3 polyunsaturated fatty acids (n3-PUFA) supplementation', 'Omega-3-Polyunsaturated Fatty']","['FMD', 'endothelial function', 'endothelial function assessed by flow-mediated vasodilation (FMD', 'omega-3 index reflecting n3-PUFA intake as well as pro-inflammatory, endothelial and platelet activation markers', 'Endothelial Function', 'ankle-brachial index (ABI), maximum and pain-free walking distances', 'omega-3 index']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0042401', 'cui_str': 'Vasorelaxation'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0032173', 'cui_str': 'Platelet Activation'}, {'cui': 'C1328319', 'cui_str': 'Ankle Brachial Index'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}]",70.0,0.502667,"In response to n3-PUFA, an improvement of lipid parameters with a pronounced increase of omega-3 index was seen.","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Hammer', 'Affiliation': 'Division of Angiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Deddo', 'Initials': 'D', 'LastName': 'Moertl', 'Affiliation': 'Karl Landsteiner Institute for the Research of Ischemic Cardiac Diseases and Rhythmology, St. Poelten, Austria.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Schlager', 'Affiliation': 'Division of Angiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Matschuck', 'Affiliation': 'Department of Angiology, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Seidinger', 'Affiliation': 'Division of Angiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Koppensteiner', 'Affiliation': 'Division of Angiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Steiner', 'Affiliation': 'Department of Angiology, University Hospital Leipzig, Leipzig, Germany.'}]",The British journal of nutrition,['10.1017/S0007114519001582']
961,30368021,Sleep quality in cigarette smokers: Associations with smoking-related outcomes and exercise.,"INTRODUCTION


Compared to the general population, cigarette smokers report poorer sleep quality. Poor sleep quality in cigarette smokers is associated with greater nicotine dependence. While exercise is known to improve sleep quality in the general population, less is known about how exercise effects sleep in those who smoke. The goal of this study was to explore the relationships between exercise, sleep, and smoking in cigarette smokers.
METHODS


Data on sleep quality (Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI)), smoking-related outcomes (e.g., cigarettes/day, Fagerstrom Test for Nicotine Dependence, Minnesota Nicotine and Withdrawal Scale, and Questionnaire of Smoking Urges) and exercise (Fitbit activity measures) were collected for 32 participants (63% female, mean age 30.3 ± 1.0 years) participating in a 12-week clinical research study. Analyses included simple linear regression models.
RESULTS


Overall, participants reported poor sleep quality at baseline (PSQI > 5). Poorer sleep quality at baseline was associated with increased withdrawal (β = 1.63 ± 0.53, p = 0.0043), craving (β = 0.51 ± 0.43, p = 0.2471), and total smoking urges (β = 1.10 ± 0.41, p = 0.0118). During follow-up (i.e., from baseline to week 12), a daily increase in exercise was associated with improved sleep quality over the same time period (PSQI: β = -0.82 ± 0.35, p = 0.0379).
CONCLUSION


Our data suggest that better sleep quality may be associated with lower levels of withdrawal, craving, and smoking urges. Further, exercise may be associated with better sleep quality in cigarette smokers. Future work should explore how increasing exercise and improving sleep quality could inform future smoking cessation interventions.",2019,"Poorer sleep quality at baseline was associated with increased withdrawal (β = 1.63 ± 0.53, p = 0.0043), craving (β = 0.51 ± 0.43, p = 0.2471), and total smoking urges (β = 1.10 ± 0.41, p = 0.0118).","['32 participants (63% female, mean age 30.3\u202f±\u202f1.0\u202fyears) participating in a 12-week clinical research study', 'cigarette smokers']",[],"['poor sleep quality', 'sleep quality (Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI)), smoking-related outcomes (e.g., cigarettes/day, Fagerstrom Test for Nicotine Dependence, Minnesota Nicotine and Withdrawal Scale, and Questionnaire of Smoking Urges) and exercise (Fitbit activity measures', 'total smoking urges', 'Sleep quality', 'Poor sleep quality', 'Poorer sleep quality', 'sleep quality']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}]",[],"[{'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0451156', 'cui_str': 'Fagerstrom test for nicotine dependence'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0155231,"Poorer sleep quality at baseline was associated with increased withdrawal (β = 1.63 ± 0.53, p = 0.0043), craving (β = 0.51 ± 0.43, p = 0.2471), and total smoking urges (β = 1.10 ± 0.41, p = 0.0118).","[{'ForeName': 'Himal', 'Initials': 'H', 'LastName': 'Purani', 'Affiliation': 'Department of Family Medicine & Community Health, Medical School, University of Minnesota, 717 Delaware Street SE, Suite 454, Minneapolis, MN 55414, United States.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Friedrichsen', 'Affiliation': 'Department of Family Medicine & Community Health, Medical School, University of Minnesota, 717 Delaware Street SE, Suite 454, Minneapolis, MN 55414, United States.'}, {'ForeName': 'Alicia M', 'Initials': 'AM', 'LastName': 'Allen', 'Affiliation': 'Department of Family & Community Medicine, College of Medicine, University of Arizona, 3950 South Country Club Drive, Suite 330, Tucson, AZ 85716, United States. Electronic address: aliciaallen@email.arizona.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2018.10.023']
962,32298728,Palivizumab Following Extremely Premature Birth Does Not Affect Pulmonary Outcomes in Adolescents.,"BACKGROUND


Prematurity is a risk factor for impaired lung function. We sought to assess the long-term effect of palivizumab immunization and extreme prematurity (<29 weeks gestation) on respiratory symptoms and pulmonary function at adolescence.
RESEARCH QUESTIONS


STUDY DESIGN AND METHODS: We examined survivors of extreme prematurity (<29 weeks gestation) at 13 to 18 years of age (study group). Study group babies who were born immediately before palivizumab immunization (nonpalivizumab group [NPG]) were compared with those babies who were born just after implementation (PG) and with a control group. For study group patients, lung function at adolescence was further compared longitudinally with that at primary school age.
RESULTS


Sixty-four adolescents aged 15.76 ± 1.52 years were included: 46 in the study group (17 PG and 29 NPG) and 18 in the control group. For the study group, wheezing episodes, inhaler use, and hospitalizations were uncommon. For the study group compared with the control group, FEV 1  percent predicted was 82.60% ± 13.54% vs 105.83% ± 13.12% (P < .001), and the lung clearance index was 7.67 ± 1.02 vs 7.46 ± 0.70 (P = .48), respectively. Study group adolescents with bronchopulmonary dysplasia had a higher lung clearance index than did adolescents with no bronchopulmonary dysplasia (7.94 ± 1.11 vs 7.20 ± 0.60; P = .002). PG and NPG adolescents were not significantly different. Comparing the study group in adolescence with primary school age, we found improvement in mean FEV 1  percent predicted bronchodilator response (0.37% ± 9.98% vs 5.67% ± 9.87%; P = .036) and mean provocative concentration causing 20% decline in FEV 1  (12.16 ± 4.71 mg/mL vs 4.14 ± 4.51 mg/mL, respectively; P < .001).
INTERPRETATION


Palivizumab did not provide any discernable long-term protective effect. Nevertheless, adolescent survivors of extreme prematurity showed good clinical and physiologic outcomes, except for mildly raised lung clearance index in patients with bronchopulmonary dysplasia. Airway hyperreactivity detected at primary school age, decreased by adolescence.",2020,"For the study group compared with the control group, FEV 1  percent predicted was 82.60% ± 13.54% vs 105.83% ± 13.12% (P < .001), and the lung clearance index was 7.67 ± 1.02 vs 7.46 ± 0.70","['Adolescents', 'patients with bronchopulmonary dysplasia', 'Sixty-four adolescents aged 15.76 ± 1.52 years were included: 46 in the study group (17 PG and 29 NPG) and 18 in the control group', 'Extremely Premature Birth', 'survivors of extreme prematurity (<29\xa0weeks gestation) at 13 to 18 years of age (study group']","['palivizumab immunization (nonpalivizumab group [NPG', 'palivizumab immunization and extreme prematurity (<29\xa0weeks gestation', 'Palivizumab']","['respiratory symptoms and pulmonary function at adolescence', 'lung clearance index', 'Airway hyperreactivity', 'bronchodilator response', 'mean provocative concentration', 'lung function at adolescence', 'wheezing episodes, inhaler use, and hospitalizations']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0068260', 'cui_str': 'N-palmitoylgalactosylsphingosine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0672596', 'cui_str': 'palivizumab'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0068260', 'cui_str': 'N-palmitoylgalactosylsphingosine'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0231990', 'cui_str': 'Lung clearance index'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",64.0,0.149305,"For the study group compared with the control group, FEV 1  percent predicted was 82.60% ± 13.54% vs 105.83% ± 13.12% (P < .001), and the lung clearance index was 7.67 ± 1.02 vs 7.46 ± 0.70","[{'ForeName': 'Nofar', 'Initials': 'N', 'LastName': 'Amitai', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Stafler', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv.""}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Blau', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv.""}, {'ForeName': 'Eytan', 'Initials': 'E', 'LastName': 'Kaplan', 'Affiliation': ""Pediatric Intensive Care Unit, Schneider Children's Medical Center of Israel, Petah Tikva; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv.""}, {'ForeName': 'Huda', 'Initials': 'H', 'LastName': 'Mussaffi', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv.""}, {'ForeName': 'Hagit', 'Initials': 'H', 'LastName': 'Levine', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv.""}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Steuer', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva.""}, {'ForeName': 'Ephraim', 'Initials': 'E', 'LastName': 'Bar-Yishay', 'Affiliation': 'Faculty of Health Sciences, Ben Gurion University of the Negev, Beer Sheba, Israel.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Klinger', 'Affiliation': ""Neonatal Intensive Care Unit, Schneider Children's Medical Center of Israel, Petah Tikva; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv.""}, {'ForeName': 'Meir Mei', 'Initials': 'MM', 'LastName': 'Zahav', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv.""}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Prais', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv. Electronic address: nofar1402@hotmail.com.""}]",Chest,['10.1016/j.chest.2020.02.075']
963,31219671,"Comparison of the effect of a compact vs a conventional, long-term education program on metabolic control in children and adolescents with type 1 diabetes: A pilot, randomized clinical trial.","BACKGROUND


Effective education is considered essential for people with type 1 diabetes mellitus (T1DM) to adhere to a complex and long-term medical regimen and to delay or prevent the onset of diabetes-related complications.
OBJECTIVE


We compared the effect of a compact, cost-effective, education program (CEPT1) vs a long-term program on the metabolic control of children and adolescents with T1DM.
METHODS


Young people aged 8 to 21 years with T1DM were randomized to a short-term (experimental) or an extensive education program (control). The experimental group participated in three sessions of 90 minutes, with one session per week, containing five short videos. The control group attended an extended program delivered through 45-minute PowerPoint lectures, with one class every 3 months. The primary outcome was change in glycated hemoglobin A1c (HbA1c) levels from baseline to endpoint (baseline, 3, 6, 9, and 12 months).
RESULTS


In total, 62 patients were randomized to the experimental (CEPT1) (n = 32) or control (n = 30) groups. Both groups showed comparable improvement in HbA1c levels at the end of 12 months (P = .183). In a per-protocol analysis, the mean HbA1c level reduction was -2.3% (-2.6, -2.0) in the experimental group and - 1.8% (-2.0, -1.5) in the control group (P = .008).
CONCLUSION


CEPT1 was comparable with an extensive education program in reducing HbA1c levels. In a per-protocol analysis, the CEPT1 was more effective than the control program in reducing HbA1c levels. CEPT1 is a simple and cost-effective tool that can equally be used in settings with limited resources and specialized centers.",2019,"In a per-protocol analysis, the CEPT1 was more effective than the control program in reducing HbA1c levels.","['children and adolescents with type 1 diabetes', '62 patients were randomized to the experimental (CEPT1) (n = 32) or control (n = 30) groups', 'Young people aged 8 to 21 years with T1DM', 'children and adolescents with T1DM', 'people with type 1 diabetes mellitus (T1DM']","['CEPT1', 'extended program delivered through 45-minute PowerPoint lectures', 'compact, cost-effective, education program (CEPT1) vs a long-term program', 'compact vs a conventional, long-term education program', 'extensive education program', 'short-term (experimental) or an extensive education program (control']","['mean HbA1c level reduction', 'glycated hemoglobin A1c (HbA1c) levels', 'HbA1c levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes (qualifier value)'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}]",62.0,0.0628227,"In a per-protocol analysis, the CEPT1 was more effective than the control program in reducing HbA1c levels.","[{'ForeName': 'César', 'Initials': 'C', 'LastName': 'Geremia', 'Affiliation': 'Institute for Children with Diabetes, Grupo Hospitalar Conceição, Porto Alegre, Brazil.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Fornari', 'Affiliation': 'Instituto da Criança com Diabetes, Grupo Hospitalar Conceição, Porto Alegre, Brazil.'}, {'ForeName': 'Balduino', 'Initials': 'B', 'LastName': 'Tschiedel', 'Affiliation': 'Instituto da Criança com Diabetes, Grupo Hospitalar Conceição, Porto Alegre, Brazil.'}]",Pediatric diabetes,['10.1111/pedi.12879']
964,31798918,"First use of cenerimod, a selective S1P 1  receptor modulator, for the treatment of SLE: a double-blind, randomised, placebo-controlled, proof-of-concept study.","Objective


To investigate the pharmacodynamics, pharmacokinetics and safety of cenerimod-a potent, oral, selective sphingosine 1-phosphate 1 receptor modulator-in patients with SLE.
Methods


This multicentre, double-blind, placebo-controlled study was conducted in two parts. In part A, patients with SLE were randomised 1:1:1:1 to receive oral cenerimod 0.5, 1 or 2 mg, or placebo once daily for 12 weeks. Following an interim safety review of part A, additional patients were randomised 3:1 for part B and received cenerimod 4 mg or placebo once daily for 12 weeks. Endpoints included changes in total lymphocyte count, SLE Disease Activity Index-2000 (SLEDAI-2K) score (modified (mSLEDAI-2K) to exclude leucopenia), biomarker anti-double-stranded DNA (anti-dsDNA) antibodies, pharmacokinetic assessments and treatment-emergent adverse events (TEAEs).
Results


Part A included 49 patients (1:1:1:1 receiving cenerimod 0.5, 1 or 2 mg, or placebo) and part B included 18 patients (13 cenerimod; 5 placebo). Cenerimod caused a statistically significant dose-dependent reduction in total lymphocyte count from baseline to end of treatment (EOT). Compared with placebo at EOT, cenerimod 4 mg had an estimated treatment effect on change from baseline in mSLEDAI-2K score of -2.420 (p=0.0306), and on anti-dsDNA antibodies of -64.55 U/mL (p=0.0082), suggesting clinical and biological improvement in these exploratory efficacy analyses. Trough plasma concentrations were dose proportional and reached steady-state conditions after 4 weeks of once daily dosing. All groups reported similar, non-dose-related frequencies of TEAEs (cenerimod 0.5 mg: 41.7%; 1 mg: 41.7%; 2 mg: 46.2%; 4 mg: 38.5% and placebo: 58.8%). A small, dose-related, non-clinically relevant decrease in heart rate was only observed in the first 6 hours after initiation.
Conclusions


With an acceptable safety profile, the efficacy findings suggest that cenerimod has the potential to treat patients with SLE. Further investigation in larger patient populations with longer treatment duration is warranted.",2019,Cenerimod caused a statistically significant dose-dependent reduction in total lymphocyte count from baseline to end of treatment (EOT).,"['patients with SLE', '49 patients (1:1:1:1 receiving']","['placebo', 'cenerimod 4\u2009mg or placebo', 'cenerimod 0.5, 1 or 2\u2009mg, or placebo', 'oral cenerimod 0.5, 1 or 2\u2009mg, or placebo']","['total lymphocyte count', 'total lymphocyte count, SLE Disease Activity Index-2000 (SLEDAI-2K) score (modified (mSLEDAI-2K) to exclude leucopenia), biomarker anti-double-stranded DNA (anti-dsDNA) antibodies, pharmacokinetic assessments and treatment-emergent adverse events (TEAEs', 'heart rate', 'Trough plasma concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0200635', 'cui_str': 'Lymphocyte Number'}, {'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0311474', 'cui_str': 'DNA, Double-Stranded'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",49.0,0.482983,Cenerimod caused a statistically significant dose-dependent reduction in total lymphocyte count from baseline to end of treatment (EOT).,"[{'ForeName': 'Viktoria', 'Initials': 'V', 'LastName': 'Hermann', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Anastas', 'Initials': 'A', 'LastName': 'Batalov', 'Affiliation': 'Rheumatology Department, Medical University of Plovdiv, Plovdiv, Bulgaria.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Smakotina', 'Affiliation': 'Kemerovo Regional Clinical Hospital, Kemerovo, Russia.'}, {'ForeName': 'Pierre-Eric', 'Initials': 'PE', 'LastName': 'Juif', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Cornelisse', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}]",Lupus science & medicine,['10.1136/lupus-2019-000354']
965,32409493,Exercise-Induced Increases in Insulin Sensitivity After Bariatric surgery are Mediated by Muscle Extracellular Matrix Remodeling.,"Exercise seems to enhance the beneficial effect of bariatric surgery (RYGB) on insulin resistance. We hypothesized that skeletal muscle extracellular matrix (ECM) remodeling may underly these benefits. Women were randomized to either a combined aerobic and resistance exercise training program following RYGB or standard of care (RYGB). Insulin sensitivity was assessed by OGTT. Muscle biopsies were obtained at baseline, and 3 and 9 months after surgery and subjected to comprehensive phenotyping, transcriptome profiling, molecular pathway identification and validation  in vitro  Exercise training improved insulin sensitivity beyond surgery alone ( e.g , Matsuda index - RYGB: +123% vs. RYGB + ET: +325%;  P  ≤ 0.0001). ECM remodeling was reduced by surgery alone, with an additive benefit of surgery and exercise training ( e.g.,  collagen I - RYGB: -41% vs. RYGB + ET: -76%;  P  ≤ 0.0001). Exercise and RYGB had an additive effect on enhancing insulin sensitivity, but surgery alone did not resolve insulin resistance and ECM remodeling. We identified candidates modulated by exercise training that may become therapeutic targets for treating insulin resistance, in particular, the transforming growth factor-beta 1/SMAD 2/3 pathway and its antagonist follistatin. Exercise-induced increases in insulin sensitivity after bariatric surgery are at least partially mediated by muscle extracellular matrix remodeling. Clinicaltrial.gov: NCT02441361.",2020,"Exercise and RYGB had an additive effect on enhancing insulin sensitivity, but surgery alone did not resolve insulin resistance and ECM remodeling.",[],"['surgery and exercise training ( e.g.,  collagen', 'combined aerobic and resistance exercise training program following RYGB or standard of care (RYGB', 'I - RYGB', 'exercise training']","['enhancing insulin sensitivity', 'ECM remodeling', 'insulin resistance and ECM remodeling', 'Insulin Sensitivity', 'insulin sensitivity', 'Insulin sensitivity']",[],"[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0015350', 'cui_str': 'Matrix, Extracellular'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",,0.0522588,"Exercise and RYGB had an additive effect on enhancing insulin sensitivity, but surgery alone did not resolve insulin resistance and ECM remodeling.","[{'ForeName': 'Wagner S', 'Initials': 'WS', 'LastName': 'Dantas', 'Affiliation': 'Integrated Physiology and Molecular Metabolism Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Hamilton', 'Initials': 'H', 'LastName': 'Roschel', 'Affiliation': 'Applied Physiology & Nutrition Research Group; School of Physical Education and Sport; Laboratory of Assessment and Conditioning in Rheumatology; Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Igor H', 'Initials': 'IH', 'LastName': 'Murai', 'Affiliation': 'Applied Physiology & Nutrition Research Group; School of Physical Education and Sport; Laboratory of Assessment and Conditioning in Rheumatology; Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Saulo', 'Initials': 'S', 'LastName': 'Gil', 'Affiliation': 'Applied Physiology & Nutrition Research Group; School of Physical Education and Sport; Laboratory of Assessment and Conditioning in Rheumatology; Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Gangarao', 'Initials': 'G', 'LastName': 'Davuluri', 'Affiliation': 'Integrated Physiology and Molecular Metabolism Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Axelrod', 'Affiliation': 'Integrated Physiology and Molecular Metabolism Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Sujoy', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Genomics Core, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Newman', 'Affiliation': 'Genomics Core, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Integrated Physiology and Molecular Metabolism Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Samuel K', 'Initials': 'SK', 'LastName': 'Shinjo', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, BR.'}, {'ForeName': 'Willian das', 'Initials': 'WD', 'LastName': 'Neves', 'Affiliation': 'Clinical Oncology Service, Instituto do Câncer do Estado de São Paulo, Sao Paulo, BR.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Merege-Filho', 'Affiliation': 'Applied Physiology & Nutrition Research Group; School of Physical Education and Sport; Laboratory of Assessment and Conditioning in Rheumatology; Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Walcy R', 'Initials': 'WR', 'LastName': 'Teodoro', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, BR.'}, {'ForeName': 'Vera L', 'Initials': 'VL', 'LastName': 'Capelozzi', 'Affiliation': 'Department of Pathology, School of Medicine, Universidade de Sao Paulo, Sao Paulo, BR.'}, {'ForeName': 'Rosa Maria', 'Initials': 'RM', 'LastName': 'Pereira', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, BR.'}, {'ForeName': 'Fabiana B', 'Initials': 'FB', 'LastName': 'Benatti', 'Affiliation': 'School of Applied Sciences, Universidade Estadual de Campinas, Sao Paulo, BR.'}, {'ForeName': 'Ana L', 'Initials': 'AL', 'LastName': 'de Sá-Pinto', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, BR.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'de Cleva', 'Affiliation': 'Department of Digestive Division, School of Medicine, Universidade de Sao Paulo, Sao Paulo, BR.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Santo', 'Affiliation': 'Department of Digestive Division, School of Medicine, Universidade de Sao Paulo, Sao Paulo, BR.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Integrated Physiology and Molecular Metabolism Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gualano', 'Affiliation': 'Applied Physiology & Nutrition Research Group; School of Physical Education and Sport; Laboratory of Assessment and Conditioning in Rheumatology; Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR gualano@usp.br.'}]",Diabetes,['10.2337/db19-1180']
966,32409561,"Hydroxychloroquine in patients with mainly mild to moderate coronavirus disease 2019: open label, randomised controlled trial.","OBJECTIVE


To assess the efficacy and safety of hydroxychloroquine plus standard of care compared with standard of care alone in adults with coronavirus disease 2019 (covid-19).
DESIGN


Multicentre, open label, randomised controlled trial.
SETTING


16 government designated covid-19 treatment centres in China, 11 to 29 February 2020.
PARTICIPANTS


150 patients admitted to hospital with laboratory confirmed covid-19 were included in the intention to treat analysis (75 patients assigned to hydroxychloroquine plus standard of care, 75 to standard of care alone).
INTERVENTIONS


Hydroxychloroquine administrated at a loading dose of 1200 mg daily for three days followed by a maintenance dose of 800 mg daily (total treatment duration: two or three weeks for patients with mild to moderate or severe disease, respectively).
MAIN OUTCOME MEASURE


Negative conversion of severe acute respiratory syndrome coronavirus 2 by 28 days, analysed according to the intention to treat principle. Adverse events were analysed in the safety population in which hydroxychloroquine recipients were participants who received at least one dose of hydroxychloroquine and hydroxychloroquine non-recipients were those managed with standard of care alone.
RESULTS


Of 150 patients, 148 had mild to moderate disease and two had severe disease. The mean duration from symptom onset to randomisation was 16.6 (SD 10.5; range 3-41) days. A total of 109 (73%) patients (56 standard of care; 53 standard of care plus hydroxychloroquine) had negative conversion well before 28 days, and the remaining 41 (27%) patients (19 standard of care; 22 standard of care plus hydroxychloroquine) were censored as they did not reach negative conversion of virus. The probability of negative conversion by 28 days in the standard of care plus hydroxychloroquine group was 85.4% (95% confidence interval 73.8% to 93.8%), similar to that in the standard of care group (81.3%, 71.2% to 89.6%). The difference between groups was 4.1% (95% confidence interval -10.3% to 18.5%). In the safety population, adverse events were recorded in 7/80 (9%) hydroxychloroquine non-recipients and in 21/70 (30%) hydroxychloroquine recipients. The most common adverse event in the hydroxychloroquine recipients was diarrhoea, reported in 7/70 (10%) patients. Two hydroxychloroquine recipients reported serious adverse events.
CONCLUSIONS


Administration of hydroxychloroquine did not result in a significantly higher probability of negative conversion than standard of care alone in patients admitted to hospital with mainly persistent mild to moderate covid-19. Adverse events were higher in hydroxychloroquine recipients than in non-recipients.
TRIAL REGISTRATION


ChiCTR2000029868.",2020,"CONCLUSIONS


Administration of hydroxychloroquine did not result in a significantly higher probability of negative conversion than standard of care alone in patients admitted to hospital with mainly persistent mild to moderate covid-19.","['adults with coronavirus disease 2019 (covid-19', 'patients with mainly mild to moderate coronavirus disease 2019', 'Of 150 patients, 148 had mild to moderate disease and two had severe disease', 'A total of 109 (73%) patients (56 standard of care; 53 standard of care plus', '16 government designated covid-19 treatment centres in China, 11 to 29 February 2020', '150 patients admitted to hospital with laboratory confirmed covid-19 were included in the intention to treat analysis (75 patients assigned to', 'patients admitted to hospital with mainly persistent mild to moderate covid-19']","['care plus hydroxychloroquine', 'hydroxychloroquine', 'Hydroxychloroquine', 'hydroxychloroquine plus standard of care, 75 to standard of care alone', 'hydroxychloroquine plus standard of care compared with standard of care alone', 'hydroxychloroquine and hydroxychloroquine']","['probability of negative conversion', 'Adverse events', 'diarrhoea', 'efficacy and safety', 'serious adverse events', 'mean duration from symptom onset to randomisation', 'adverse events', 'negative conversion']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",150.0,0.283224,"CONCLUSIONS


Administration of hydroxychloroquine did not result in a significantly higher probability of negative conversion than standard of care alone in patients admitted to hospital with mainly persistent mild to moderate covid-19.","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhujun', 'Initials': 'Z', 'LastName': 'Cao', 'Affiliation': 'Department of Infectious Disease, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.'}, {'ForeName': 'Mingfeng', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': ""Department of Respiratory Medicine, No 2 People's Hospital of Fuyang City, Fuyang, Anhui, China.""}, {'ForeName': 'Zhengyan', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory Medicine, Suizhou Hospital, Hubei University of Medicine, Suizhou, Hubei, China.'}, {'ForeName': 'Junwen', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Xiangyang No 1 People's Hospital, Hubei University of Medicine, Xiangyang, Hubei, China.""}, {'ForeName': 'Wenjin', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Department of Infectious Diseases, Central Hospital of Ezhou, Ezhou, Hubei, China.'}, {'ForeName': 'Yaojie', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Department of Cardiovascular Medicine, Yunmeng People's Hospital, Xiaogan, Hubei, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': ""Department of Respiratory Medicine, First People's Hospital of Jingzhou City, Jingzhou, Hubei, China.""}, {'ForeName': 'Shengyong', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Infectious Diseases, Xiaogan Hospital Affiliated to Wuhan University of Science and Technology, Xiaogan, Hubei, China.'}, {'ForeName': 'Erzhen', 'Initials': 'E', 'LastName': 'Chen', 'Affiliation': 'Department of Emergency Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiongbiao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory Medicine, Putuo Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jiuyong', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Respiratory Medicine, Hubei Space Hospital of Xiaogan, Xiaogan, Hubei, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Gastroenterology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Qingxia', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': ""Department of Infectious Disease, The Sixth People's Hospital of Zhengzhou, Zhengzhou, Henan, China.""}, {'ForeName': 'Youqin', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Department of Infectious Disease, Wuhan No 7 Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Zhibin', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Departments of Respiratory Medicine, Xiaogan Hospital Affiliated to Wuhan University of Science and Technology, Xiaogan, Hubei, China xieqingrjh@163.com.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Department of Respiratory Medicine, The Third People's Hospital of Yichang, Yichang, Hubei, China.""}, {'ForeName': 'Yaofeng', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Respiratory Medicine, Xiao Gan First People's Hospital, Xiaogan, Hubei Province, China.""}, {'ForeName': 'Leshan', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Clinical Research Centre, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jieming', 'Initials': 'J', 'LastName': 'Qu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Ning', 'Affiliation': 'Shanghai National Research Centre for Endocrine and Metabolic Diseases, State Key Laboratory of Medical Genomics, Shanghai Institute for Endocrine and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Guochao', 'Initials': 'G', 'LastName': 'Shi', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xie', 'Affiliation': 'Department of Infectious Disease, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China xieqingrjh@163.com.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m1849']
967,32116827,A Multicenter Phase II RCT to Compare the Effectiveness of EMDR Versus TAU in Patients With a First-Episode Psychosis and Psychological Trauma: A Protocol Design.,"Background


Patients with a first episode psychosis (FEP) who are admitted for the first time to a psychiatric hospital frequently have experienced prior psychological trauma. Additionally, 40-80% develop posttraumatic stress symptoms, which are summarized as a post-psychotic post-traumatic syndrome (PPS). Eye Movement Desensitization and reprocessing (EMDR) therapy could be an effective psychotherapy to treat a PPS and prior psychological traumas in this population.
Objectives


To assess if EMDR therapy leads to: 1) a reduction of relapses after intervention, 2) an improvement of trauma-related, psychotic and affective symptoms, 3) an improvement of overall functioning, and 4) an improvement in quality of life.
Methods


This is a multicenter phase II rater-blinded randomized controlled trial in which 80 FEP patients with a history of psychological trauma will be randomly assigned to EMDR (n = 40) or to TAU (n = 40). Traumatic events will be measured by the Global Assessment of Posttraumatic Stress Questionnaire, the Cumulative Trauma Screening, the Impact of Event Scale-Revised, the Dissociative Experiences Scale, the Childhood Trauma Scale, the Holmes-Rahe Life Stress Inventory, and the Dissociative Experiences Questionnaire. Clinical symptomatology will be evaluated using the Suicide and Drug Consumption module of the International Neuropsychiatric Interview, Structured Clinical Interview for Positive and Negative Syndrome Scale, Young's Scale for Mania Evaluation, and Beck Depression II Questionnaire. Functionality will be assessed with the Global Assessment of Functioning and the Quality of Life with the Standardized Instrument developed by the EuroQol Group. The cognitive insight and adherence to the treatment will be assessed with the Beck Cognitive Insight Scale and the Drug Attitude Inventory. All variables will be measured at baseline, post-treatment and at 12-month follow-up.
Conclusion


This study will provide evidence of whether EMDR therapy is effective in reducing trauma and clinical symptoms, reducing relapses and in improving functionality and quality of life in patients with FEP and a history of trauma.
Clinical Trial Registration


www.ClinicalTrials.gov, identifier: NCT03991377.",2019,"To assess if EMDR therapy leads to: 1) a reduction of relapses after intervention, 2) an improvement of trauma-related, psychotic and affective symptoms, 3) an improvement of overall functioning, and 4) an improvement in quality of life.
","['patients with FEP and a history of trauma', 'Patients With a First-Episode Psychosis and Psychological Trauma', '80 FEP patients with a history of psychological trauma', '\n\n\nPatients with a first episode psychosis (FEP) who are admitted for the first time to a psychiatric hospital frequently have experienced prior psychological trauma']","['EMDR Versus TAU', 'TAU', 'EMDR therapy', 'Eye Movement Desensitization and reprocessing (EMDR) therapy', 'EMDR']","['posttraumatic stress symptoms', 'Traumatic events', 'Beck Cognitive Insight Scale and the Drug Attitude Inventory', 'functionality and quality of life', 'quality of life', 'Global Assessment of Posttraumatic Stress Questionnaire, the Cumulative Trauma Screening, the Impact of Event Scale-Revised, the Dissociative Experiences Scale, the Childhood Trauma Scale, the Holmes-Rahe Life Stress Inventory, and the Dissociative Experiences Questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C3203533', 'cui_str': 'Psychological Trauma'}, {'cui': 'C0455506', 'cui_str': 'H/O: psychological trauma'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0020021', 'cui_str': 'Mental Hospitals'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}]","[{'cui': 'C0870535', 'cui_str': 'EMDR'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0556520', 'cui_str': 'Desensitization (Psychology)'}]","[{'cui': 'C0521991', 'cui_str': 'Symptoms of stress (finding)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0233820', 'cui_str': 'Self-understanding'}, {'cui': 'C0222045'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034380'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C3472482', 'cui_str': 'Impact of event scale revised (assessment scale)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0038443', 'cui_str': 'Stressor, Psychological'}]",80.0,0.0779765,"To assess if EMDR therapy leads to: 1) a reduction of relapses after intervention, 2) an improvement of trauma-related, psychotic and affective symptoms, 3) an improvement of overall functioning, and 4) an improvement in quality of life.
","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Valiente-Gómez', 'Affiliation': 'Centre Forum Research Unit, Institut de Neuropsiquiatria i Addiccions (INAD), Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Pujol', 'Affiliation': 'IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Moreno-Alcázar', 'Affiliation': 'Centre Forum Research Unit, Institut de Neuropsiquiatria i Addiccions (INAD), Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Radua', 'Affiliation': ""Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Eila', 'Initials': 'E', 'LastName': 'Monteagudo-Gimeno', 'Affiliation': 'Department of Psychiatry and Forensic Medicine, School of Medicine Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Itxaso', 'Initials': 'I', 'LastName': 'Gardoki-Souto', 'Affiliation': 'Centre Forum Research Unit, Institut de Neuropsiquiatria i Addiccions (INAD), Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Hogg', 'Affiliation': 'Centre Forum Research Unit, Institut de Neuropsiquiatria i Addiccions (INAD), Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'Maria José', 'Initials': 'MJ', 'LastName': 'Álvarez', 'Affiliation': 'Mental Health Department, Vic Hospital Consortium, Barcelona, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Safont', 'Affiliation': 'CIBERSAM, Madrid, Spain.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Lupo', 'Affiliation': 'Centre Forum Research Unit, Institut de Neuropsiquiatria i Addiccions (INAD), Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Pérez', 'Affiliation': 'IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.'}, {'ForeName': 'Benedikt L', 'Initials': 'BL', 'LastName': 'Amann', 'Affiliation': 'Centre Forum Research Unit, Institut de Neuropsiquiatria i Addiccions (INAD), Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Frontiers in psychiatry,['10.3389/fpsyt.2019.01023']
968,31800812,Educational intervention to promote self-care in older adults with diabetes mellitus.,"OBJECTIVE


To evaluate the efficacy of an educational nursing intervention in self-care for older adults who have Diabetes Mellitus.
METHOD


A quasi-experimental study with control and intervention two groups conducted with older adults living with Diabetes Mellitus, attended at Primary Health Care Units of Fortaleza/Ceará. The intervention was a group educational approach with guidelines on diabetes treatment and foot care. The Brazilian adapted version of the Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) was used for evaluating before-and-after self-care. A significance level of 0.05 was considered.
RESULTS


103 older adults participated in the study. There was an increase in self-care for diabetes after the educational intervention related to the aspects: healthy diet (p = 0.027), dietary instruction (p = 0.013) and foot examination (p = 0.012).
CONCLUSION


The performed intervention promoted positive behavioral changes, favoring the adoption of healthy habits and the promotion of self-care in older adult patients with Diabetes Mellitus.",2019,"There was an increase in self-care for diabetes after the educational intervention related to the aspects: healthy diet (p = 0.027), dietary instruction (p = 0.013) and foot examination (p = 0.012).
","['older adult patients with Diabetes Mellitus', 'older adults living with Diabetes Mellitus, attended at Primary Health Care Units of Fortaleza/Ceará', '103 older adults participated in the study', 'older adults with diabetes mellitus', 'older adults who have Diabetes Mellitus']","['educational nursing intervention', 'educational approach with guidelines on diabetes treatment and foot care', 'Educational intervention']","['Diabetes Self-Care Activities Questionnaire (SDSCA', 'positive behavioral changes', 'self-care for diabetes']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0150240', 'cui_str': 'Foot care'}]","[{'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",103.0,0.0129108,"There was an increase in self-care for diabetes after the educational intervention related to the aspects: healthy diet (p = 0.027), dietary instruction (p = 0.013) and foot examination (p = 0.012).
","[{'ForeName': 'Marilia Braga', 'Initials': 'MB', 'LastName': 'Marques', 'Affiliation': 'Universidade Federal do Ceará, Faculdade de Farmácia, Odontologia e Enfermagem, Programa de Pós-Graduação em Enfermagem, Fortaleza, Ceará, Brasil.'}, {'ForeName': 'Janaína Fonseca Victor', 'Initials': 'JFV', 'LastName': 'Coutinho', 'Affiliation': 'Universidade Federal do Ceará, Faculdade de Farmácia, Odontologia e Enfermagem, Programa de Pós-Graduação em Enfermagem, Fortaleza, Ceará, Brasil.'}, {'ForeName': 'Mariana Cavalcante', 'Initials': 'MC', 'LastName': 'Martins', 'Affiliation': 'Universidade Federal do Ceará, Faculdade de Farmácia, Odontologia e Enfermagem, Programa de Pós-Graduação em Enfermagem, Fortaleza, Ceará, Brasil.'}, {'ForeName': 'Marcos Venícios de Oliveira', 'Initials': 'MVO', 'LastName': 'Lopes', 'Affiliation': 'Universidade Federal do Ceará, Faculdade de Farmácia, Odontologia e Enfermagem, Programa de Pós-Graduação em Enfermagem, Fortaleza, Ceará, Brasil.'}, {'ForeName': 'Juliana Cunha', 'Initials': 'JC', 'LastName': 'Maia', 'Affiliation': 'Universidade Federal do Ceará, Faculdade de Farmácia, Odontologia e Enfermagem, Programa de Pós-Graduação em Enfermagem, Fortaleza, Ceará, Brasil.'}, {'ForeName': 'Maria Josefina da', 'Initials': 'MJD', 'LastName': 'Silva', 'Affiliation': 'Universidade Federal do Ceará, Faculdade de Farmácia, Odontologia e Enfermagem, Programa de Pós-Graduação em Enfermagem, Fortaleza, Ceará, Brasil.'}]",Revista da Escola de Enfermagem da U S P,['10.1590/S1980-220X2018026703517']
969,31800817,Auricular acupressure in the quality of life of women with breast cancer: a randomized clinical trial.,"OBJECTIVE


To evaluate the effects of an auricular acupressure intervention on the quality of life of women with breast cancer undergoing chemotherapy compared with those who did not undergo the intervention.
METHOD


A randomized clinical trial with 54 women followed weekly for 12 weeks, with 27 being allocated to the intervention group in which crystal pellets were applied to six acupoints (shen men, kidney, stomach, cardia, brainstem and endocrine), and 27 in the control group. Quality of life was measured in five stages; the first before starting the intervention, and the following stages every three weeks using the Quality of Life Questionnaire - Core 30 and the Quality of Life Questionnaire - Breast Cancer BR-23 instruments.
RESULTS


There was improvement in all domains related to quality of life; however, there was significance regarding nausea, vomiting and breast symptoms in the intervention group.
CONCLUSION


Auricular acupressure has proven to be a safe, effective, low cost method with no side effects and easily applicable by trained nurses. It may be recommended as complementary therapy in treating breast cancer to improve the quality of life of these women. The study was registered in the Brazilian Registry of Clinical Trials with the code no. RBR-36zcfg.",2019,"There was improvement in all domains related to quality of life; however, there was significance regarding nausea, vomiting and breast symptoms in the intervention group.
","['54 women followed weekly for 12 weeks, with 27 being allocated to the intervention group in which crystal pellets were applied to six acupoints (shen men, kidney, stomach, cardia, brainstem and endocrine), and 27 in the control group', 'women with breast cancer', 'women with breast cancer undergoing chemotherapy compared with those who did not undergo the intervention']","['Auricular acupressure', 'RBR-36zcfg', 'auricular acupressure intervention']","['nausea, vomiting and breast symptoms', 'Quality of Life Questionnaire - Core 30 and the Quality of Life Questionnaire - Breast Cancer BR-23 instruments', 'Quality of life', 'quality of life']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0427896', 'cui_str': 'Crystal - human material (substance)'}, {'cui': 'C1998480', 'cui_str': 'Pellet - unit of product usage (qualifier value)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C3714551', 'cui_str': 'Stomach structure (body structure)'}, {'cui': 'C0007144', 'cui_str': 'Cardia'}, {'cui': 'C0006121', 'cui_str': 'Truncus Cerebri'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C4551823', 'cui_str': 'instruments'}]",,0.0515652,"There was improvement in all domains related to quality of life; however, there was significance regarding nausea, vomiting and breast symptoms in the intervention group.
","[{'ForeName': 'Elizabeth Tischenberg Aguiar', 'Initials': 'ETA', 'LastName': 'Vallim', 'Affiliation': 'Universidade Federal do Paraná, Programa de Pós-Graduação em Enfermagem, Curitiba, PR, Brasil.'}, {'ForeName': 'Angela da Costa Barcellos', 'Initials': 'ADCB', 'LastName': 'Marques', 'Affiliation': 'Universidade Federal do Paraná, Programa de Pós-Graduação em Enfermagem, Curitiba, PR, Brasil.'}, {'ForeName': 'Raquel de Castro Figueiredo Pereira', 'Initials': 'RCFP', 'LastName': 'Coelho', 'Affiliation': 'Universidade Federal do Paraná, Programa de Pós-Graduação em Enfermagem, Curitiba, PR, Brasil.'}, {'ForeName': 'Paulo Ricardo Bittencourt', 'Initials': 'PRB', 'LastName': 'Guimarães', 'Affiliation': 'Universidade Federal do Paraná, Programa de Pós-Graduação em Engenharia Florestal, Curitiba, PR, Brasil.'}, {'ForeName': 'Jorge Vinicius Cestari', 'Initials': 'JVC', 'LastName': 'Felix', 'Affiliation': 'Universidade Federal do Paraná, Departamento de Enfermagem, Curitiba, PR, Brasil.'}, {'ForeName': 'Luciana Puchalski', 'Initials': 'LP', 'LastName': 'Kalinke', 'Affiliation': 'Pontifícia Universidade Católica do Paraná, Curitiba, PR, Brasil.'}]",Revista da Escola de Enfermagem da U S P,['10.1590/S1980-220X2018043603525']
970,31800822,The effectiveness of an online training program in a nursing unit: extraction of blood cultures.,"OBJECTIVE


To assess the effectiveness of an online training platform for procedures among nurses in an internal medicine unit to reduce the number of contaminated blood cultures.
METHOD


This was a quasi-experimental pre-post intervention parallel group study. The sample consisted of internal medicine nurses in a tertiary hospital who participated in an online training program about blood culture extraction technique. Knowledge about the technique was measured pre- and post-intervention. Additionally, the study compared the number of blood cultures taken 6 months before and 3 months after the intervention.
RESULTS


Forty-eight nurses participated. Pre-intervention knowledge was homogeneous among both groups, improving significantly after the online training program (p=0.0001). The blood cultures taken prior to the training showed contamination levels above international standards; post-intervention, contamination levels fell by up to 3% in the intervention group.
CONCLUSION


The educational intervention using the digital platform increased knowledge about the procedure and its application in clinical practice.",2019,"intervention knowledge was homogeneous among both groups, improving significantly after the online training program (p=0.0001).","['internal medicine nurses in a tertiary hospital who participated in an', 'Forty-eight nurses participated']","['online training program about blood culture extraction technique', 'online training platform', 'online training program']",['number of blood cultures'],"[{'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0200949', 'cui_str': 'Blood Culture Test'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0200949', 'cui_str': 'Blood Culture Test'}]",48.0,0.0168508,"intervention knowledge was homogeneous among both groups, improving significantly after the online training program (p=0.0001).","[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Zaragoza-García', 'Affiliation': 'Universidad Complutense de Madrid, Facultad de Enfermería, Fisioterapia y Podología, Departamento de Enfermería, Madrid, España.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Pérez-García', 'Affiliation': 'Universidad Complutense de Madrid, Facultad de Enfermería, Fisioterapia y Podología, Departamento de Enfermería, Madrid, España.'}, {'ForeName': 'María de Los Ángeles', 'Initials': 'MLÁ', 'LastName': 'Orellana-Miguel', 'Affiliation': 'Instituto de Investigación Sanitaria Hospital 12 de Octubre (Instituto i+12), Madrid, España.'}, {'ForeName': 'Clotilde', 'Initials': 'C', 'LastName': 'Posé-Becerra', 'Affiliation': 'Instituto de Investigación Sanitaria Hospital 12 de Octubre (Instituto i+12), Madrid, España.'}, {'ForeName': 'María Andión', 'Initials': 'MA', 'LastName': 'Goñi-Olangua', 'Affiliation': 'Instituto de Investigación Sanitaria Hospital 12 de Octubre (Instituto i+12), Madrid, España.'}]",Revista da Escola de Enfermagem da U S P,['10.1590/S1980-220X2018040003531']
971,31244434,Co-ultraPEALut: Role in Preclinical and Clinical Delirium Manifestations.,"BACKGROUND


Delirium is a disorder in awareness, attention and cognition. Pathophysiologically it is a response to stress. Postoperative delirium (POD) is a usual complication in aged patients following hip fracture surgery. Neuroinflammation is an important factor linked with the progress of POD. Though there are no efficient cures for delirium the endocannabinoid system may have a role in neuropsychiatric disorders.
OBJECTIVE


Therefore, we examined the effects of co-ultramicronized PEALut (co-ultraPEALut) in the LPS murine model of delirium and in elderly hip fractured patients.
METHODS


In the preclinical study, mice were injected intraperitoneally (i.p.) with Escherichia coli LPS (10 mg/kg). Co-ultraPEALut (1 mg/kg o.s.) was administered 1h before LPS injection or 1h and 6h after LPS injection or 1h before LPS injection and 1h and 6h after LPS. In the clinical study, the effects of Glialia® (co-ultramicronized 700 mg PEA + 70 mg luteolin) administration was evaluated in elderly hip fractured patients with an interventional, randomized, single-blind, monocentric study.
RESULTS


Administration of co-ultraPEALut to LPS-challenged mice ameliorated cognitive dysfunctions and locomotor activity; moreover, it reduced inflammation and apoptosis, while stimulating antioxidant response and limiting the loss of neurotrophins. In the clinical study, the results obtained demonstrated that administration of Glialia® to these surgical patients prevented the onset of POD and attenuated symptom intensity and their duration.
CONCLUSION


Therefore, the results obtained enhanced the idea that co-ultraPEALut may be a potential treatment to control cognitive impairment and the inflammatory and oxidative processes associated with delirium.",2019,"RESULTS


Administration of co-ultraPEALut to LPS-challenged mice ameliorated cognitive dysfunctions and locomotor activity; moreover, it reduced inflammation and apoptosis, while stimulating antioxidant response and limiting the loss of neurotrophins.","['elderly hip fractured patients', 'aged patients following hip fracture surgery', 'elderly hip fractured patients with an interventional, randomized, single-blind, monocentric study']","['Glialia® (co-ultramicronized 700 mg PEA + 70 mg luteolin', 'Co-ultraPEALut', 'Glialia®', 'co-ultramicronized PEALut (co-ultraPEALut', 'Escherichia coli LPS']","['cognitive dysfunctions and locomotor activity', 'Postoperative delirium (POD', 'onset of POD and attenuated symptom intensity and their duration']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0030738', 'cui_str': 'Peas'}, {'cui': 'C0065264', 'cui_str': 'Luteolin'}, {'cui': 'C4309121', 'cui_str': 'co-ultraPEALut'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}]","[{'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}, {'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",,0.0447037,"RESULTS


Administration of co-ultraPEALut to LPS-challenged mice ameliorated cognitive dysfunctions and locomotor activity; moreover, it reduced inflammation and apoptosis, while stimulating antioxidant response and limiting the loss of neurotrophins.","[{'ForeName': 'Maria Lia', 'Initials': 'ML', 'LastName': 'Lunardelli', 'Affiliation': ""Geriatric Unit - Orthogeriatric Ward, Universitary Sant'Orsola Policlinic Bologna, Bologna, Italy.""}, {'ForeName': 'Rosalia', 'Initials': 'R', 'LastName': 'Crupi', 'Affiliation': 'Department of Chemical, Biological, Pharmaceutical and Environmental Science, University of Messina, Messina, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Siracusa', 'Affiliation': 'Department of Chemical, Biological, Pharmaceutical and Environmental Science, University of Messina, Messina, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Cocuzza', 'Affiliation': ""Geriatric Unit - Orthogeriatric Ward, Universitary Sant'Orsola Policlinic Bologna, Bologna, Italy.""}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Cordaro', 'Affiliation': 'Department of Chemical, Biological, Pharmaceutical and Environmental Science, University of Messina, Messina, Italy.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Martini', 'Affiliation': ""Geriatric Unit - Orthogeriatric Ward, Universitary Sant'Orsola Policlinic Bologna, Bologna, Italy.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Impellizzeri', 'Affiliation': 'Department of Chemical, Biological, Pharmaceutical and Environmental Science, University of Messina, Messina, Italy.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Di Paola', 'Affiliation': 'Department of Chemical, Biological, Pharmaceutical and Environmental Science, University of Messina, Messina, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Cuzzocrea', 'Affiliation': 'Department of Chemical, Biological, Pharmaceutical and Environmental Science, University of Messina, Messina, Italy.'}]",CNS & neurological disorders drug targets,['10.2174/1871527318666190617162041']
972,32409691,A dose-finding Phase 2 study of single agent isatuximab (anti-CD38 mAb) in relapsed/refractory multiple myeloma.,"A Phase 2 dose-finding study evaluated isatuximab, an anti-CD38 monoclonal antibody, in relapsed/refractory multiple myeloma (RRMM; NCT01084252). Patients with ≥3 prior lines or refractory to both immunomodulatory drugs and proteasome inhibitors (dual refractory) were randomized to isatuximab 3 mg/kg every 2 weeks (Q2W), 10 mg/kg Q2W(2 cycles)/Q4W, or 10 mg/kg Q2W. A fourth arm evaluated 20 mg/kg QW(1 cycle)/Q2W. Patients (N = 97) had a median (range) age of 62 years (38-85), 5 (2-14) prior therapy lines, and 85% were double refractory. The overall response rate (ORR) was 4.3, 20.0, 29.2, and 24.0% with isatuximab 3 mg/kg Q2W, 10 mg/kg Q2W/Q4W, 10 mg/kg Q2W, and 20 mg/kg QW/Q2W, respectively. At doses ≥10 mg/kg, median progression-free survival and overall survival were 4.6 and 18.7 months, respectively, and the ORR was 40.9% (9/22) in patients with high-risk cytogenetics. CD38 receptor density was similar in responders and non-responders. The most common non-hematologic adverse events (typically grade ≤2) were nausea (34.0%), fatigue (32.0%), and upper respiratory tract infections (28.9%). Infusion reactions (typically with first infusion and grade ≤2) occurred in 51.5% of patients. In conclusion, isatuximab is active and generally well tolerated in heavily pretreated RRMM, with greatest efficacy at doses ≥10 mg/kg.",2020,"median progression-free survival and overall survival were 4.6 and 18.7 months, respectively, and the ORR was 40.9% (9/22) in patients with high-risk cytogenetics.","['Patients with ≥3 prior lines or refractory to both immunomodulatory drugs and proteasome inhibitors (dual refractory', 'Patients (N\u2009=\u200997) had a median (range) age of 62 years (38-85), 5 (2-14) prior therapy lines, and 85% were double refractory', 'relapsed/refractory multiple myeloma']","['isatuximab 3\u2009mg/kg every 2 weeks (Q2W), 10\u2009mg/kg Q2W(2 cycles)/Q4W, or 10\u2009mg/kg Q2W', 'QW(1 cycle)/Q2W', 'single agent isatuximab (anti-CD38 mAb']","['fatigue', 'upper respiratory tract infections', 'overall response rate (ORR', 'ORR', 'median progression-free survival and overall survival', 'hematologic adverse events', 'nausea', 'CD38 receptor density']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1443643', 'cui_str': 'Proteasome inhibitor'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}]","[{'cui': 'C4330502', 'cui_str': 'isatuximab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0075742', 'cui_str': 'Lymphocyte antigen CD38'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0075742', 'cui_str': 'Lymphocyte antigen CD38'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",,0.0601734,"median progression-free survival and overall survival were 4.6 and 18.7 months, respectively, and the ORR was 40.9% (9/22) in patients with high-risk cytogenetics.","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Mikhael', 'Affiliation': 'Mayo Clinic, Scottsdale, AZ, USA. jmikhael@myeloma.org.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Richter', 'Affiliation': 'Hackensack University Medical Center, Hackensack, NJ, USA.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Vij', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Cole', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Zonder', 'Affiliation': 'Karmanos Cancer Institute, Detroit, MI, USA.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Kaufman', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, GA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Bensinger', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Meletios', 'Initials': 'M', 'LastName': 'Dimopoulos', 'Affiliation': 'National and Kapodistrian University of Athens School of Medicine, Athens, Greece.'}, {'ForeName': 'Nikoletta', 'Initials': 'N', 'LastName': 'Lendvai', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Parameswaran', 'Initials': 'P', 'LastName': 'Hari', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Enrique M', 'Initials': 'EM', 'LastName': 'Ocio', 'Affiliation': 'Hospital Universitario Marqués de Valdecilla (IDIVAL), Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gasparetto', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Shaji', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Oprea', 'Affiliation': 'Sanofi Oncology R&D, Vitry/Alfortville, France.'}, {'ForeName': 'Marielle', 'Initials': 'M', 'LastName': 'Chiron', 'Affiliation': 'Sanofi Oncology R&D, Vitry/Alfortville, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Brillac', 'Affiliation': 'Sanofi Oncology R&D, Vitry/Alfortville, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Charpentier', 'Affiliation': 'Sanofi Genzyme Oncology, Cambridge, MA, USA.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'San-Miguel', 'Affiliation': 'Clinica Universidad de Navarra, CIMA, IDISNA, CIBERONC, Pamplona, Spain.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Martin', 'Affiliation': 'University of California at San Francisco, San Francisco, CA, USA.'}]",Leukemia,['10.1038/s41375-020-0857-2']
973,31233079,Twenty-Four Months' Resistance and Endurance Training Improves Muscle Size and Physical Functions but Not Muscle Quality in Older Adults Requiring Long-Term Care.,"OBJECTIVES


To assess the effects of 24 months training on muscle quality, size, strength, and gait abilities in older adults who need long-term care.
DESIGN


Non-randomized controlled trial Setting: Kawai Rehabilitation Center and Kajinoki Medical Clinic.
PARTICIPANTS


Ten older participants who needed long-term care (age, 76.7 ± 5.6 years) were participated as training group (Tr-group) and 10 older men and women who did not require long-term care (age, 72.9 ± 6.6 years) comprised the control group (Cont-group).
INTERVENTION


Tr-group performed resistive and endurance exercises once or twice a week for 24 months.
MEASUREMENTS


Using ultrasound images, echo intensity (EI) and muscle thickness were measured in the rectus femoris and biceps femoris as an index of muscle quality and size. Physical performance was measured before and after the training; performance parameters included knee extension peak torque, 5-m normal and maximal walk test, sit-to-stand and timed up and go test.
RESULTS


After the training, there was no change in EI, while BF thickness was increased (pre; 1.82 ± 0.29 cm, 24 months; 2.14 ± 0.23 cm, p < 0.05) in Tr-group. Walk-related performances were improved after the training in Tr-group (i.e. 5-m walk test and timed up and go test). The percent change of knee extension peak torque explained the percent change of EI in the rectus femoris (regression coefficient = 1.24, R = 0.91, adjusted R2 = 0.82, p < 0.001).
CONCLUSIONS


Twenty-four months' training induced muscle hypertrophy and improved physical functions. Increased muscle quality in the rectus femoris could be a key to improved knee extension peak torque, with the potential to eventually reduce the need for long-term care in older individuals.",2019,Walk-related performances were improved after the training in Tr-group (i.e. 5-m walk test and timed up and go test).,"['Ten older participants who needed long-term care (age, 76.7 ± 5.6 years) were participated as training group (Tr-group) and 10 older men and women who did not require long-term care (age, 72.9 ± 6.6 years', 'Older Adults Requiring Long-Term Care', 'older adults who need long-term care']","['Endurance Training', 'Tr-group performed resistive and endurance exercises', 'control group (Cont-group']","['change in EI, while BF thickness', 'Muscle Size and Physical Functions', 'Physical performance', 'muscle hypertrophy and improved physical functions', 'knee extension peak torque', 'muscle quality', 'knee extension peak torque, 5-m normal and maximal walk test, sit-to-stand and timed up and go test', 'muscle quality, size, strength, and gait abilities', 'Using ultrasound images, echo intensity (EI) and muscle thickness', 'rectus femoris and biceps femoris as an index of muscle quality and size']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0023977'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C4517823', 'cui_str': '6.6 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise (regime/therapy)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2607857'}, {'cui': 'C0236033', 'cui_str': 'Muscle hypertrophy (finding)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0584894', 'cui_str': 'Rectus Femoris'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",10.0,0.0197952,Walk-related performances were improved after the training in Tr-group (i.e. 5-m walk test and timed up and go test).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Yoshiko', 'Affiliation': 'Akito Yoshiko, Ph.D. School of International Liberal Studies, Chukyo University, 101 Tokodachi, Kaizu, Toyota, Aichi 470-0393, Japan, Tel: +81 (565) 46-6952, E-mail: yoshiko@lets.chukyo-u.ac.jp.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kaji', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Sugiyama', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Koike', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Oshida', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Akima', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-019-1208-8']
974,30910531,"A multifaceted intervention to improve syphilis screening and treatment in pregnant women in Kinshasa, Democratic Republic of the Congo and in Lusaka, Zambia: a cluster randomised controlled trial.","BACKGROUND


Despite international recommendations, coverage of syphilis testing in pregnant women and treatment of those found seropositive remains limited in sub-Saharan Africa. We assessed whether combining the provision of supplies with a behavioural intervention was more effective than providing supplies only, to improve syphilis screening and treatment during antenatal care.
METHODS


In this 18-month, cluster randomised controlled trial, we randomly assigned (1:1) 26 urban antenatal care clinics in Kinshasa, Democratic Republic of the Congo, and Lusaka, Zambia, to receive a behavioural intervention (opinion leader selection, academic detailing visits, reminders, audits and feedback, and supportive supervision) plus supplies for syphilis testing and treatment (intervention group) or to receive supplies only (control group). The primary outcomes were proportion of pregnant women who had syphilis screening out of the total who attended the clinic; and the proportion of women who had treatment with benzathine benzylpenicillin out of those who tested positive for syphilis at their first antenatal care visit. This trial is registered at ClinicalTrials.gov, number NCT02353117.
FINDINGS


The 18-month study period was Feb 1, 2016, to July 14, 2017. 18 357 women were enrolled at the 13 intervention clinics and 17 679 women were enrolled at the 13 control clinics at their first antenatal care visit. Syphilis screening was done in a median of 99·9% (IQR 99·0-100·0) of women in the intervention clinics and 93·8% (85·0-98·9) in the control clinics (absolute difference 6·1% [95% CI 1·1-14·1]; p=0·00092). Syphilis treatment at the first visit was done in a median of 100% (IQR 99·7-100·0) of seropositive women in intervention clinics and 43·2% (2·6-83·2) of seropositive women in control clinics (absolute difference 56·8% [12·8-99·0]; p=0·0028).
INTERPRETATION


A behavioural intervention, together with the provision of supplies, can lead to more than 95% of women being screened and treated for syphilis. The sole provision of supplies is sufficient to reach such levels of screening coverage but is not sufficient to ensure high levels of treatment.
FUNDING


Bill & Melinda Gates Foundation.",2019,Syphilis screening was done in a median of 99·9% (IQR 99·0-100·0) of women in the intervention clinics and 93·8% (85·0-98·9) in the control clinics (absolute difference 6·1% [95% CI 1·1-14·1]; p=0·00092).,"['pregnant women who had syphilis screening out of the total who attended the clinic; and the proportion of women who had treatment with benzathine benzylpenicillin out of those who tested positive for syphilis at their first antenatal care visit', 'pregnant women', '18\u2008357 women were enrolled at the 13 intervention clinics and 17\u2008679 women were enrolled at the 13 control clinics at their first antenatal care visit', 'pregnant women in Kinshasa, Democratic Republic of the Congo and in Lusaka, Zambia', '26 urban antenatal care clinics in Kinshasa, Democratic Republic of the Congo, and Lusaka, Zambia, to receive a']","['behavioural intervention (opinion leader selection, academic detailing visits, reminders, audits and feedback, and supportive supervision) plus supplies for syphilis testing and treatment (intervention group) or to receive supplies only (control group', 'multifaceted intervention']",[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030829', 'cui_str': 'penicillin G benzathine'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0043444', 'cui_str': 'Belgian Congo'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}]","[{'cui': 'C0871010', 'cui_str': 'Opinions'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0039128', 'cui_str': 'Great Pox'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205291', 'cui_str': 'Multifaceted (qualifier value)'}]",[],18357.0,0.140212,Syphilis screening was done in a median of 99·9% (IQR 99·0-100·0) of women in the intervention clinics and 93·8% (85·0-98·9) in the control clinics (absolute difference 6·1% [95% CI 1·1-14·1]; p=0·00092).,"[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Althabe', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina; UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Reproductive Health and Research, WHO, Geneva, Switzerland.'}, {'ForeName': 'Elwyn', 'Initials': 'E', 'LastName': 'Chomba', 'Affiliation': 'University Teaching Hospital of Lusaka, Lusaka, Zambia.'}, {'ForeName': 'Antoinette K', 'Initials': 'AK', 'LastName': 'Tshefu', 'Affiliation': 'Kinshasa School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Banda', 'Affiliation': 'University Teaching Hospital of Lusaka, Lusaka, Zambia.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Belizán', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bergel', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.'}, {'ForeName': 'Mabel', 'Initials': 'M', 'LastName': 'Berrueta', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina. Electronic address: mberrueta@iecs.org.ar.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Bertrand', 'Affiliation': 'Tulane University School of Public Health and Tropical Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Bose', 'Affiliation': 'University of North Carolina (UNC) School of Medicine, UNC Hospitals, Chapel Hill, NC, USA.'}, {'ForeName': 'Maria Luisa', 'Initials': 'ML', 'LastName': 'Cafferata', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.'}, {'ForeName': 'Waldemar A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Ciganda', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Donnay', 'Affiliation': 'Tulane University School of Public Health and Tropical Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Ezequiel', 'Initials': 'E', 'LastName': 'García Elorrio', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.'}, {'ForeName': 'Luz', 'Initials': 'L', 'LastName': 'Gibbons', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Klein', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.'}, {'ForeName': 'Jerker', 'Initials': 'J', 'LastName': 'Liljestrand', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, WA, USA.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Lusamba', 'Affiliation': 'Kinshasa School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Arlette K', 'Initials': 'AK', 'LastName': 'Mavila', 'Affiliation': 'Kinshasa School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Agustina', 'Initials': 'A', 'LastName': 'Mazzoni', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.'}, {'ForeName': 'Dalau M', 'Initials': 'DM', 'LastName': 'Nkamba', 'Affiliation': 'Kinshasa School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Friday H', 'Initials': 'FH', 'LastName': 'Mwanakalanga', 'Affiliation': 'University Teaching Hospital of Lusaka, Lusaka, Zambia.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Mwapule Tembo', 'Affiliation': 'University Teaching Hospital of Lusaka, Lusaka, Zambia.'}, {'ForeName': 'Musaku', 'Initials': 'M', 'LastName': 'Mwenechanya', 'Affiliation': 'University Teaching Hospital of Lusaka, Lusaka, Zambia.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Pyne-Mercier', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, WA, USA.'}, {'ForeName': 'Cintia', 'Initials': 'C', 'LastName': 'Spira', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.'}, {'ForeName': 'Jean D', 'Initials': 'JD', 'LastName': 'Wetshikoy', 'Affiliation': 'Kinshasa School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Xiong', 'Affiliation': 'Tulane University School of Public Health and Tropical Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Buekens', 'Affiliation': 'Tulane University School of Public Health and Tropical Medicine, Los Angeles, CA, USA.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30075-0']
975,32409485,Randomized phase 2 study of adjunctive cenobamate in patients with uncontrolled focal seizures.,"OBJECTIVE


To evaluate the efficacy and safety of adjunctive cenobamate 200 mg/d in patients with uncontrolled focal (partial-onset) seizures despite treatment with 1 to 3 antiepileptic drugs.
METHODS


In this multicenter, double-blind, placebo-controlled study, adults 18 to 65 years of age with focal seizures were randomized 1:1 (cenobamate:placebo) after an 8-week baseline period. The 12-week double-blind treatment period consisted of a 6-week titration phase and a 6-week maintenance phase. The primary outcome was percent change in seizure frequency (from baseline) per 28 days during double-blind treatment.
RESULTS


Two hundred twenty-two patients were randomized; 113 received cenobamate and 109 received placebo; and 90.3% and 90.8% of patients, respectively, completed double-blind treatment. Median baseline seizure frequency was 6.5 in 28 days (range 0-237). Compared to placebo, cenobamate conferred a greater median percent seizure reduction (55.6% vs 21.5%;  p  < 0.0001) The responder rate (≥50% reduction in seizure frequency) was 50.4% for cenobamate and 22.2% for placebo ( p  < 0.0001). Focal seizures with motor component, impaired awareness, and focal to bilateral tonic-clonic seizures were significantly reduced with cenobamate vs placebo. During maintenance, 28.3% of cenobamate-treated and 8.8% of placebo-treated patients were seizure-free. Treatment-emergent adverse events reported in >10% in either group (cenobamate vs placebo) were somnolence (22.1% vs 11.9%), dizziness (22.1% vs 16.5%), headache (12.4% vs 12.8%), nausea (11.5% vs 4.6%), and fatigue (10.6% vs 6.4%).
CONCLUSION


Adjunctive treatment with cenobamate 200 mg/d significantly improved seizure control in adults with uncontrolled focal seizures and was well tolerated.
CLINICALTRIALSGOV IDENTIFIER


NCT01397968.
CLASSIFICATION OF EVIDENCE


This study provides Class I evidence that, for patients with uncontrolled focal seizures, adjunctive cenobamate reduces seizures.",2020,The responder rate (≥50% reduction in seizure frequency) was 50.4% for cenobamate and 22.2% for placebo ( p  < 0.0001).,"['patients with uncontrolled focal seizures', 'adults 18 to 65 years of age with focal seizures', 'Two hundred twenty-two patients were randomized; 113 received', 'patients with uncontrolled focal (partial-onset) seizures despite treatment with 1 to 3 antiepileptic drugs', 'patients with uncontrolled focal seizures, adjunctive cenobamate reduces seizures']","['adjunctive cenobamate', 'cenobamate vs placebo', 'cenobamate', 'placebo']","['headache', 'Median baseline seizure frequency', 'dizziness', 'responder rate', 'fatigue', 'seizure-free', 'efficacy and safety', 'somnolence', 'Focal seizures with motor component, impaired awareness, and focal to bilateral tonic-clonic seizures', 'nausea', 'percent change in seizure frequency', 'median percent seizure reduction', 'seizure control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",222.0,0.791106,The responder rate (≥50% reduction in seizure frequency) was 50.4% for cenobamate and 22.2% for placebo ( p  < 0.0001).,"[{'ForeName': 'Steve S', 'Initials': 'SS', 'LastName': 'Chung', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ. steve.chung@bannerhealth.com.'}, {'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'French', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Kowalski', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Krauss', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}, {'ForeName': 'Sang Kun', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Maciejowski', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Rosenfeld', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Sperling', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Mizne', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Kamin', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}]",Neurology,['10.1212/WNL.0000000000009530']
976,31799981,Irisin and troponin I expression in dialysis patients submitted to remote ischemic preconditioning: a pilot study.,"BACKGROUND


Renal replacement therapy continues to be related to high hospitalization rates and poor quality of life. All-cause morbidity and mortality in renal replacement therapy in greater than 20% per year, being 44 times greater when diabetes is present, and over 10 times that of the general population. Regardless of treatment, the 5-year survival is 40%, surpassing many types of cancers. Irisin is a hormone that converts white adipose tissue into beige adipose tissue, aggregating positive effects like fat mass control, glucose tolerance, insulin resistance, prevention of muscle loss, and reduction in systemic inflammation.
OBJECTIVES


To determine the serum levels of troponin I in hemodialysis patients submitted to remote ischemic preconditioning (RIPC) associated with irisin expression.
METHODS


This was a prospective, randomized, double-blind clinical trial with patients with chronic kidney disease submitted to hemodialysis for a 6-month period. Troponin I, IL-6, urea, TNF-α, and creatinine levels were determined from blood samples. The expressions of irisin, thioredoxin, Nf-kb, GPX4, selenoprotein and GADPH were also evaluated by RT-PCR.
RESULTS


Samples from 14 hypertensive patients were analyzed, 9 (64.3%) of whom were type 2 diabetics, aged 44-64 years, and 50% of each sex. The difference between pre- and post-intervention levels of troponin I was not significant. No differences were verified between the RIPC and control groups, except for IL-6, although a significant correlation was observed between irisin and troponin I.
CONCLUSION


Remote ischemic preconditioning did not modify irisin or troponin I expression, independent of the time of collection.",2020,"The expressions of irisin, thioredoxin, Nf-kb, GPX4, selenoprotein and GADPH were also evaluated by RT-PCR.
","['patients with chronic kidney disease submitted to hemodialysis for a 6-month period', '14 hypertensive patients were analyzed, 9 (64.3%) of whom were type 2 diabetics, aged 44-64 years, and 50% of each sex']","['remote ischemic preconditioning', 'remote ischemic preconditioning (RIPC']","['Irisin and troponin', 'serum levels of troponin', '5-year survival', 'irisin or troponin', 'expressions of irisin, thioredoxin, Nf-kb, GPX4, selenoprotein and GADPH', 'Troponin I, IL-6, urea, TNF-α, and creatinine levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1709632', 'cui_str': 'Precondition (attribute)'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}]","[{'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C3496084', 'cui_str': 'Thioredoxin'}, {'cui': 'C0079904', 'cui_str': 'Nuclear Factor-Kappab'}, {'cui': 'C0074302', 'cui_str': 'Selenoproteins'}, {'cui': 'C0920210', 'cui_str': 'Troponin I measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0428279', 'cui_str': 'Finding of creatinine level (finding)'}]",,0.1188,"The expressions of irisin, thioredoxin, Nf-kb, GPX4, selenoprotein and GADPH were also evaluated by RT-PCR.
","[{'ForeName': 'Flávia de Sousa', 'Initials': 'FS', 'LastName': 'Gehrke', 'Affiliation': 'Departamento de Farmácia, Universidade Paulista, São Paulo, SP, Brasil.'}, {'ForeName': 'Mariana Carvalho', 'Initials': 'MC', 'LastName': 'Gouveia', 'Affiliation': 'Departamento de Nefrologia, Centro Universitário em Saúde do ABC, Santo André, SP, Brasil.'}, {'ForeName': 'Carla Gabriela Marques', 'Initials': 'CGM', 'LastName': 'Barbosa', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Instituto de Assistência Médica ao Servidor Público Estadual, São Paulo, SP, Brasil.'}, {'ForeName': 'Neif', 'Initials': 'N', 'LastName': 'Murad', 'Affiliation': 'Departamento de Cardiologia, Centro Universitário em Saúde do ABC, Santo André, SP, Brasil.'}, {'ForeName': 'Beatriz da Costa Aguiar Alves', 'Initials': 'BCAA', 'LastName': 'Reis', 'Affiliation': 'Laboratório de Análises Clínicas, Centro Universitário em Saúde do ABC, Santo André, SP, Brasil.'}, {'ForeName': 'Fernando Luiz Affonso', 'Initials': 'FLA', 'LastName': 'Fonseca', 'Affiliation': 'Laboratório de Análises Clínicas, Centro Universitário em Saúde do ABC, Santo André, SP, Brasil.'}, {'ForeName': 'Edimar Cristiano', 'Initials': 'EC', 'LastName': 'Pereira', 'Affiliation': 'Departamento de Ciências Farmacêuticas, Universidade Federal de São Paulo, Diadema, SP, Brasil.'}, {'ForeName': 'Marcelo Rodrigues', 'Initials': 'MR', 'LastName': 'Bacci', 'Affiliation': 'Departamento de Nefrologia, Centro Universitário em Saúde do ABC, Santo André, SP, Brasil.'}]",Jornal brasileiro de nefrologia : 'orgao oficial de Sociedades Brasileira e Latino-Americana de Nefrologia,['10.1590/2175-8239-jbn-2019-0051']
977,32068418,Mechanisms of change in female-specific and gender-neutral cognitive behavioral therapy for women with alcohol use disorder.,"OBJECTIVE


In a randomized trial for women with alcohol use disorders (AUD), the efficacy of Female-Specific Cognitive Behavioral Therapy (FS-CBT) was compared with Gender-Neutral CBT (GN-CBT; Epstein et al., 2018). The current study examined whether putative mechanisms of change differed between treatment conditions, using a novel statistical approach. Both treatments were hypothesized to work by increasing use of alcohol-related coping skills (coping) and confidence to abstain from drinking (confidence), but FS-CBT additionally targeted female-salient mechanisms: anxiety, depression, sociotropy (i.e., overinvestment in others' opinion of oneself), autonomy, and social networks supportive of abstinence.
METHOD


Ninety-nine women with AUD (55 in GN-CBT, 44 in FS-CBT) completed self-report assessments at baseline and 0, 6, and 12 months posttreatment. Multilevel vector autoregression estimation was used to analyze associations between putative mechanisms of change, and network models of those associations were generated using network analysis.
RESULTS


Across conditions, higher confidence and coping were directly associated with less drinking; autonomy was directly and indirectly associated with drinking. Additionally, network analysis indicated that although variation in depression was associated with change in other variables specifically for GN-CBT, sociotropy was associated with change specifically in FS-CBT.
CONCLUSIONS


Women receiving CBT-AUD changed their drinking through increased confidence to abstain and greater use of coping skills. Autonomy played a central role in behavior change across treatment conditions. Participants receiving treatment tailored to women also changed through decreases in sociotropy and increases in social support for abstinence. For women who received standard CBT, changes in depression were important to clinical improvement. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Both treatments were hypothesized to work by increasing use of alcohol-related coping skills (coping) and confidence to abstain from drinking (confidence), but FS-CBT additionally targeted female-salient mechanisms: anxiety, depression, sociotropy (i.e., overinvestment in others' opinion of oneself), autonomy, and social networks supportive of abstinence.
","['women with alcohol use disorders (AUD', 'women with alcohol use disorder', 'Ninety-nine women with AUD (55 in GN-CBT, 44 in FS-CBT) completed self-report assessments at baseline and 0, 6, and 12 months posttreatment']",['Female-Specific Cognitive Behavioral Therapy (FS-CBT'],['social support for abstinence'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]",[{'cui': 'C0037438'}],99.0,0.0294468,"Both treatments were hypothesized to work by increasing use of alcohol-related coping skills (coping) and confidence to abstain from drinking (confidence), but FS-CBT additionally targeted female-salient mechanisms: anxiety, depression, sociotropy (i.e., overinvestment in others' opinion of oneself), autonomy, and social networks supportive of abstinence.
","[{'ForeName': 'Cathryn Glanton', 'Initials': 'CG', 'LastName': 'Holzhauer', 'Affiliation': 'Division of Addiction Psychiatry, Department of Psychiatry, University of Massachusetts Medical School.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hildebrandt', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Epstein', 'Affiliation': 'Division of Addiction Psychiatry, Department of Psychiatry, University of Massachusetts Medical School.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'McCrady', 'Affiliation': 'Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Hallgren', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': 'Center of Alcohol Studies, Rutgers University.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000492']
978,31241362,EFFICACY AND SAFETY OF IGLARLIXI IN HISPANICS AND NON-HISPANIC WHITES WITH TYPE 2 DIABETES.,"Objective:  Type 2 diabetes (T2D) is more common in Hispanic than non-Hispanic white (NHW) populations worldwide, and ethnicity, among other factors, may affect response to therapy. The efficacy and safety of insulin glargine 100 units/mL (iGlar) and the fixed-ratio combination of iGlar and the glucagon-like peptide 1 receptor agonist lixisenatide (iGlarLixi) was assessed in Hispanic and NHW patients with T2D from 25 countries.  Methods:  In this post hoc analysis, data from two 30-week randomized controlled trials comparing iGlar and iGlarLixi in patients with T2D uncontrolled on basal insulin ± oral antidiabetes drugs (OADs; LixiLan-L: NCT02058160) or uncontrolled on metformin ± OADs (LixiLan-O: NCT02058147) were evaluated.  Results:  Of the 1,512 patients included across trials, 301 were Hispanic and 1,211 NHW. Compared with iGlar, iGlarLixi resulted in greater reductions in glycated hemoglobin (A1C) and 2-hour postprandial glucose and a higher proportion of patients at target A1C <7.0% (<53 mmol/mol), regardless of ethnicity. Among NHWs from the LixiLan-L trial, documented symptomatic hypoglycemia (plasma glucose ≤70 mg/dL) rates were higher with iGlar compared with iGlarLixi ( P  = .06), whereas this trend was reversed among Hispanics ( P  = .07). Nevertheless, in both trials, a greater proportion of patients taking iGlarLixi than iGlar reached the composite efficacy endpoints of target A1C without hypoglycemia and target A1C without weight gain, regardless of ethnicity.  Conclusion:  These results indicate that iGlarLixi is a viable therapeutic option for both Hispanic and NHW patients with T2D, as it is efficacious without a significant increase in hypoglycemia, irrespective of ethnicity.  Abbreviations: A1C  = glycated hemoglobin;  BMI  = body mass index;  FPG  = fasting plasma glucose;  FRC  = fixed-ratio combination;  GLP-1 RA  = glucagon-like peptide 1 receptor agonist;  HDL-C  = high-density-lipoprotein cholesterol;  iGlar  = insulin glargine;  iGlarLixi  = insulin glargine + lixisenatide;  LDL-C  = low-density-lipoprotein cholesterol;  NHW  = non-Hispanic white;  OAD  = oral antidiabetes drug;  PPG  = postprandial glucose;  T2D  = type 2 diabetes.",2019,"mg/dL) rates were higher with iGlar compared with iGlarLixi ( P =.06), whereas, this trend was reversed among Hispanics ( P =.07).","['1,512 patients included across trials, 301 were Hispanic and 1,211 NHW', '≤70', 'Hispanic and NHW patients with T2D from 25 countries', 'patients with T2D uncontrolled on basal insulin ± oral antidiabetes drugs (OADs; LixiLan-L']","['iGlarLixi', 'iGlar, iGlarLixi', 'iGlar and iGlarLixi', 'fixed-ratio combination of iGlar and the glucagon-like peptide-1 receptor agonist lixisenatide (iGlarLixi', 'insulin glargine']","['glycated hemoglobin (A1C) and 2-hour postprandial glucose', 'symptomatic hypoglycemia (plasma glucose', 'hypoglycemia', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C2973895', 'cui_str': 'Lixisenatide'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1512.0,0.0880236,"mg/dL) rates were higher with iGlar compared with iGlarLixi ( P =.06), whereas, this trend was reversed among Hispanics ( P =.07).","[{'ForeName': 'Pablo F', 'Initials': 'PF', 'LastName': 'Mora', 'Affiliation': ''}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Chao', 'Affiliation': ''}, {'ForeName': 'Aramesh', 'Initials': 'A', 'LastName': 'Saremi', 'Affiliation': ''}, {'ForeName': 'Terry A', 'Initials': 'TA', 'LastName': 'Dex', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Roberts', 'Affiliation': ''}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': ''}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.4158/EP-2018-0615']
979,30801508,Glass Slippers and Glass Cliffs: Fitting In and Falling Off.,"BACKGROUND


A glass ceiling effect exists for women in male-dominated professions. Recent studies also show a glass-cliff effect where senior women can more easily fall from positions of leadership. Transplantation remains a male-dominated specialty. This study investigated gender and the perception of adverse clinical incidents in transplantation.
METHODS


Prospective randomised web-based survey involving five clinical scenarios presenting two versions of episodes with errors or mistakes, with either a male or female as a randomly named protagonist (Set1 and Set2). To address unconscious bias, the study was described as examining actions following clinical adverse incidents in transplantation. Each scenario was followed by 2 closed questions: (1) clinical performance rating and (2) selection of action required. Reasoning was invited (open-text comments). Responses were analyzed using quantitative and qualitative methods.
RESULTS


One hundred ninety-one invitees responded; 134 completed questionnaires. There were no statistically significant differences (P > 0.05) in responses between sets for performance ratings or recommended actions. However, for ""first solo laparoscopic surgery"" scenario, there was some indication that ""No Action"" was more likely if surgeon was male (P = 0.056). Male responses rated female performance as significantly worse (P = 0.035) for the laboratory-based scenario. One hundred two participants provided open-text comments. Thematic analysis identified 7 themes. Acceptable levels of risk theme demonstrated engendered leadership beliefs, that is, when clinical judgment proved incorrect, males described as forceful but females as needing support. In cases where things went wrong, respondents were more likely to comment females should not have decided to proceed.
CONCLUSIONS


While gender may no longer be an overt issue in perceived performance of senior staff in transplantation, respondents' use of language and their choice of words display elements of unconscious (covert) engendered views.",2019,There were no statistically significant differences (P > 0.05) in responses between sets for performance ratings or recommended actions.,"['women in male-dominated professions', 'Prospective randomised web-based survey involving five clinical scenarios presenting two versions of episodes with errors or mistakes, with either a male or female as a randomly named protagonist (Set1 and Set2', 'One hundred ninety-one invitees responded; 134 completed questionnaires']",['Glass Slippers and Glass Cliffs'],[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4522128', 'cui_str': 'Name (property)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0017596', 'cui_str': 'Glass'}, {'cui': 'C0453958', 'cui_str': 'Slippers (physical object)'}, {'cui': 'C0442530', 'cui_str': 'Cliff (environment)'}]",[],102.0,0.064063,There were no statistically significant differences (P > 0.05) in responses between sets for performance ratings or recommended actions.,"[{'ForeName': 'Nithya', 'Initials': 'N', 'LastName': 'Krishnan', 'Affiliation': 'Renal Unit, University Hospitals Coventry & Warwickshire NHS Trust, Coventry, United Kingdom.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Biggerstaff', 'Affiliation': 'Mental Health and Wellbeing, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, United Kingdom.'}, {'ForeName': 'Ala', 'Initials': 'A', 'LastName': 'Szczepura', 'Affiliation': 'Enterprise & Innovation, University of Coventry, Coventry, United Kingdom.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Dolton', 'Affiliation': 'Transplantation Research Immunology Group, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Sondra', 'Initials': 'S', 'LastName': 'Livingston', 'Affiliation': 'Director of Operations, The Transplantation Society, Montreal, QC, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hattersley', 'Affiliation': 'Renal Unit, University Hospitals Coventry & Warwickshire NHS Trust, Coventry, United Kingdom.'}, {'ForeName': 'Josette', 'Initials': 'J', 'LastName': 'Eris', 'Affiliation': 'Renal Transplantation, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Ascher', 'Affiliation': 'Transplantation, University College San Francisco, San Francisco, CA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Higgins', 'Affiliation': 'Renal Unit, University Hospitals Coventry & Warwickshire NHS Trust, Coventry, United Kingdom.'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Braun', 'Affiliation': 'Transplantation, University College San Francisco, San Francisco, CA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Wood', 'Affiliation': 'Transplantation Research Immunology Group, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Raymond', 'Affiliation': 'Renal Unit, University Hospitals Coventry & Warwickshire NHS Trust, Coventry, United Kingdom.'}]",Transplantation,['10.1097/TP.0000000000002603']
980,31056676,Evidence in a Cluster Randomized Controlled Trial of Increased 2009 Pandemic Risk Associated With 2008-2009 Seasonal Influenza Vaccine Receipt.,,2019,,['2009 pandemic risk associated with 2008-09 seasonal influenza vaccine receipt'],[],[],"[{'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course (qualifier value)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]",[],[],,0.236922,,"[{'ForeName': 'Danuta M', 'Initials': 'DM', 'LastName': 'Skowronski', 'Affiliation': 'Communicable Diseases and Immunization Services, British Columbia Centre for Disease Control, Vancouver.'}, {'ForeName': 'Gaston', 'Initials': 'G', 'LastName': 'De Serres', 'Affiliation': 'Direction of Biological and Occupational Risks, Institut National de Santé Publique du Québec, Quebec, Canada.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz351']
981,31195357,"Nivolumab plus ipilimumab versus chemotherapy as first-line treatment in advanced non-small-cell lung cancer with high tumour mutational burden: patient-reported outcomes results from the randomised, open-label, phase III CheckMate 227 trial.","BACKGROUND


In the phase III CheckMate 227 study, first-line nivolumab + ipilimumab significantly prolonged progression-free survival (co-primary end-point) versus chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC) and high tumour mutational burden (TMB; ≥10 mutations/megabase).
AIM


To evaluate patient-reported outcomes (PROs) in this population.
METHODS


Disease-related symptoms and general health status were assessed using the validated PRO questionnaires Lung Cancer Symptom Scale (LCSS) and EQ-5D, respectively. LCSS average symptom burden index (ASBI) and three-item global index (3-IGI) and EQ-5D visual analogue scale (VAS) and utility index (UI) scores and changes from baseline were analysed descriptively. Longitudinal changes were assessed by mixed-effect model repeated measures (MMRMs) and time to first deterioration/improvement analyses.
RESULTS


In the high TMB population, PRO questionnaire completion rates were ∼90% at baseline and >80% for most on-treatment assessments. During treatment, mean changes from baseline with nivolumab + ipilimumab showed early, clinically meaningful improvements in LCSS ASBI/3-IGI and EQ-5D VAS/UI; with chemotherapy, symptoms and health-related quality of life remained stable (LCSS ASBI/3-IGI, EQ-5D UI) or improved following induction (EQ-5D VAS). MMRM-assessed changes in symptom burden were improved with nivolumab + ipilimumab versus chemotherapy. Symptom deterioration by week 12 was lower with nivolumab + ipilimumab versus chemotherapy (22.3% versus 35.0%; absolute risk reduction: 12.7% [95% confidence interval 2.4-22.5]), irrespective of discontinuation. Time to first deterioration was delayed with nivolumab + ipilimumab versus chemotherapy across LCSS and EQ-5D summary measures.
CONCLUSION


First-line nivolumab + ipilimumab demonstrated early, sustained improvements in PROs versus chemotherapy in patients with advanced NSCLC and high TMB.
CLINICAL TRIAL REGISTRATION


NCT02477826.",2019,"Time to first deterioration was delayed with nivolumab + ipilimumab versus chemotherapy across LCSS and EQ-5D summary measures.
","['patients with advanced non-small-cell lung cancer (NSCLC) and high tumour mutational burden (TMB; ≥10 mutations/megabase', 'advanced non-small-cell lung cancer with high tumour mutational burden', 'patients with advanced NSCLC and high TMB']","['Nivolumab plus ipilimumab versus chemotherapy', 'chemotherapy']","['PRO questionnaire completion rates', 'progression-free survival', 'MMRM-assessed changes in symptom burden', 'utility index (UI) scores', 'LCSS ASBI/3-IGI and EQ-5D VAS/UI; with chemotherapy, symptoms and health-related quality of life remained stable (LCSS ASBI/3-IGI, EQ-5D UI', 'Symptom deterioration', 'LCSS average symptom burden index (ASBI) and three-item global index (3-IGI)\xa0and EQ-5D visual analogue scale (VAS) and', 'validated PRO questionnaires Lung Cancer Symptom Scale (LCSS) and EQ-5D, respectively']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1533164', 'cui_str': 'Megabase'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0222045'}]",,0.0904609,"Time to first deterioration was delayed with nivolumab + ipilimumab versus chemotherapy across LCSS and EQ-5D summary measures.
","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'LungenClinic Grosshansdorf, Airway Research Center North (ARCN), German Center for Lung Research (DZL), Wöhrendamm 80, 22927 Grosshansdorf, Germany. Electronic address: m.reck@lungenclinic.de.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schenker', 'Affiliation': 'Centrul de Oncologie Sf Nectarie, 23A Caracal St, Craiova, 200347, Romania. Electronic address: mike_schenker@yahoo.com.'}, {'ForeName': 'Ki Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Chungbuk National University Hospital, 776, 1 Sunhwan-ro, Seowon-gu, Cheongju-si, Chungcheonbuk-do, 28644, South Korea. Electronic address: kihlee@chungbuk.ac.kr.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Provencio', 'Affiliation': 'Universidad Autónoma de Madrid, Instituto de Investigación Puerta de Hierro, Hospital Puerta de Hierro de Majadahonda, C / Manuel de Falla 1, Madrid, Majadahonda, 28222, Spain. Electronic address: mprovenciop@gmail.com.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Nishio', 'Affiliation': 'The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Tokyo, Koto-ku, 135-8550, Japan. Electronic address: mnishio@jfcr.or.jp.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Lesniewski-Kmak', 'Affiliation': 'Oddzial Onkologii Radioterapii Szpital/Gdansk Medical University, UI. Powstania Styczniowego 1, Gdynia, 81-519, Poland. Electronic address: krzychu03@hotmail.com.'}, {'ForeName': 'Randeep', 'Initials': 'R', 'LastName': 'Sangha', 'Affiliation': 'Cross Cancer Institute, 11560 University Ave, Edmonton, Alberta, T6G 1Z2, Canada. Electronic address: randeep.sangha@albertahealthservices.ca.'}, {'ForeName': 'Samreen', 'Initials': 'S', 'LastName': 'Ahmed', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Department of Infection, Leicester, Leicestershire, LE1 5WW, UK. Electronic address: samreen.ahmed@uhl-tr.nhs.uk.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Raimbourg', 'Affiliation': ""Institut de Cancérologie de l'Ouest, Centre Rene Gauducheau, Boulevard Jacques Monod, 44805 Nantes-Saint Herblain Cedex, France. Electronic address: judith.raimbourg@ico.unicancer.fr.""}, {'ForeName': 'Kynan', 'Initials': 'K', 'LastName': 'Feeney', 'Affiliation': 'Notre Dame University and Edith Cowan University, 100 Murdoch Drive, Murdoch, Perth, Western Australia, 6150, Australia. Electronic address: kynan@oncowest.com.au.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Corre', 'Affiliation': 'CHU de Rennes, 2 Rue Henri le Guilloux, Rennes, 35033, France. Electronic address: romain.corre@chu-rennes.fr.'}, {'ForeName': 'Fabio Andre', 'Initials': 'FA', 'LastName': 'Franke', 'Affiliation': 'CACON, Hospital de Caridade de Ijuí, Av David Jose Martins, Centro, Ijuí, Rio Grande do Sul, 98700-000, Brazil. Electronic address: ff.oncosite@gmail.com.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Richardet', 'Affiliation': 'IONC - Universidad Católica de Córdoba, Parana 560. 2 Piso, Cordoba, 5000, Argentina. Electronic address: eduardorichardet@gmail.com.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Penrod', 'Affiliation': 'Bristol-Myers Squibb, 3401 Princeton Pike, Lawrenceville, NJ, 08648, USA. Electronic address: john.penrod@bms.com.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Bristol-Myers Squibb, 3401 Princeton Pike, Lawrenceville, NJ, 08648, USA. Electronic address: yong.yuan@bms.com.'}, {'ForeName': 'Faith E', 'Initials': 'FE', 'LastName': 'Nathan', 'Affiliation': 'Bristol-Myers Squibb, 3401 Princeton Pike, Lawrenceville, NJ, 08648, USA. Electronic address: faith.nathan@bms.com.'}, {'ForeName': 'Prabhu', 'Initials': 'P', 'LastName': 'Bhagavatheeswaran', 'Affiliation': 'Bristol-Myers Squibb, 3401 Princeton Pike, Lawrenceville, NJ, 08648, USA. Electronic address: prabhu.bhagavatheeswaran@bms.com.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'DeRosa', 'Affiliation': 'Adelphi Values, 290 Congress Street 7th Floor, Boston, MA, 02210, USA. Electronic address: michael.derosa@adelphivalues.com.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Taylor', 'Affiliation': 'Adelphi Values, 290 Congress Street 7th Floor, Boston, MA, 02210, USA. Electronic address: fiona.taylor@adelphivalues.com.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Lawrance', 'Affiliation': 'Adelphi Values, Adelphi Mill, Grimshaw Ln, Bollington, Cheshire, SK10 5JB, UK. Electronic address: rachael.lawrance@adelphivalues.com.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Brahmer', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, 1650 Orleans St, CRB1-G94, Baltimore, MD, 21287, USA. Electronic address: brahmju@jhmi.edu.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.05.008']
982,14069731,CLINICAL TRIAL WITH ENTAMIDE FUROATE IN ACUTE AMEBIC DYSENTERY.,,1963,,[],[],[],[],[],[],,0.0615179,,"[{'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'DHARIWAL', 'Affiliation': ''}, {'ForeName': 'N P', 'Initials': 'NP', 'LastName': 'VERMA', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'NIOGUY', 'Affiliation': ''}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'PAL', 'Affiliation': ''}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'SINGH', 'Affiliation': ''}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'CHATTERJEE', 'Affiliation': ''}, {'ForeName': 'D B', 'Initials': 'DB', 'LastName': 'BISHT', 'Affiliation': ''}]",Indian journal of medical sciences,[]
983,31228006,"Comparison between hemodynamic effects of propofol and thiopental during general anesthesia induction with remifentanil infusion: a double-blind, age-stratified, randomized study.","PURPOSE


Propofol is commonly used with remifentanil for induction of general anesthesia (GA); however, it often leads to hypotension. Intraoperative hypotension is associated with postoperative adverse events. By contrast, thiopental has less negative inotropic effects on hemodynamics compared to propofol, which could be suitable to prevent hypotension during GA induction. In the present age-stratified, randomized, assessor-blinded study, using the ClearSight ®  system, we compared the hemodynamic effects of propofol and thiopental during GA induction under remifentanil infusion in non-cardiac surgery.
METHODS


Patients were divided into young (20-40 year), middle (41-70 year), and elderly (> 70 year) groups (n = 20, each group). General anesthesia was induced with remifentanil 0.3 μg/kg/min, followed by propofol (2.0, 1.5, and 1.2 mg/kg) or thiopental (5.0, 4.0, and 3.0 mg/kg) in the young, middle, and elderly groups, respectively. The primary outcome was the difference in the decrease in mean arterial blood pressure between patients receiving propofol and thiopental in each age group. The secondary outcomes included other hemodynamic parameters and minimal bispectral index values measured up to 10 min after tracheal intubation.
RESULTS


The decrease in mean arterial blood pressure was greater in patients receiving propofol than those receiving thiopental (- 45.4 vs - 26.6 mmHg and - 45.7 vs - 28.9 mmHg, P = 0.003 and 0.007, respectively), whereas no significant difference was observed in the young age group (P = 0.96).
CONCLUSIONS


Thiopental is a more suitable agent than propofol for avoiding hypotension during GA induction under remifentanil infusion in the middle and elderly patients.",2019,"The decrease in mean arterial blood pressure was greater in patients receiving propofol than those receiving thiopental (- 45.4 vs - 26.6 mmHg and - 45.7 vs - 28.9 mmHg, P = 0.003 and 0.007, respectively), whereas no significant difference was observed in the young age group (P = 0.96).
","['Patients were divided into young (20-40\xa0year), middle (41-70\xa0year), and elderly (>\u200970\xa0year) groups (n\u2009=\u200920, each group', 'middle and elderly patients']","['remifentanil infusion', 'remifentanil 0.3\xa0μg/kg/min, followed by propofol', 'propofol and thiopental', 'propofol and thiopental during GA induction under remifentanil infusion', 'propofol', 'remifentanil', 'thiopental', 'Propofol', 'Thiopental']","['mean arterial blood pressure', 'Intraoperative hypotension', 'hemodynamic parameters and minimal bispectral index values']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0039925', 'cui_str': 'Thiopental'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0620839,"The decrease in mean arterial blood pressure was greater in patients receiving propofol than those receiving thiopental (- 45.4 vs - 26.6 mmHg and - 45.7 vs - 28.9 mmHg, P = 0.003 and 0.007, respectively), whereas no significant difference was observed in the young age group (P = 0.96).
","[{'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Hino', 'Affiliation': 'Department of Anesthesiology, Osaka City University Graduate School of Medicine, 1-5-7 Asahimachi, Abeno-ku, Osaka, 545-8586, Japan. m1165192@yahoo.co.jp.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Matsuura', 'Affiliation': 'Department of Anesthesiology, Osaka City University Graduate School of Medicine, 1-5-7 Asahimachi, Abeno-ku, Osaka, 545-8586, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Kihara', 'Affiliation': 'Department of Anesthesiology, Osaka City University Graduate School of Medicine, 1-5-7 Asahimachi, Abeno-ku, Osaka, 545-8586, Japan.'}, {'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Tsujikawa', 'Affiliation': 'Department of Anesthesiology, Osaka City University Graduate School of Medicine, 1-5-7 Asahimachi, Abeno-ku, Osaka, 545-8586, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Mori', 'Affiliation': 'Department of Anesthesiology, Osaka City University Graduate School of Medicine, 1-5-7 Asahimachi, Abeno-ku, Osaka, 545-8586, Japan.'}, {'ForeName': 'Kiyonobu', 'Initials': 'K', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Anesthesiology, Osaka City University Graduate School of Medicine, 1-5-7 Asahimachi, Abeno-ku, Osaka, 545-8586, Japan.'}]",Journal of anesthesia,['10.1007/s00540-019-02657-x']
984,32410398,Retraction: Cervical mucus removal prior to intrauterine insemination: a randomized trial.,,2020,,[],['Retraction: Cervical mucus removal prior to intrauterine insemination'],[],[],"[{'cui': 'C0332523', 'cui_str': 'Retraction'}, {'cui': 'C0007872', 'cui_str': 'Cervical mucus'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}]",[],,0.0306512,,[],BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16164']
985,32410400,Expression of concern: Nifedipine alone or combined with sildenafil citrate for management of threatened preterm labour: a randomised trial.,,2020,,['threatened preterm labour'],['Nifedipine alone or combined with sildenafil citrate'],[],"[{'cui': 'C0022876', 'cui_str': 'Premature labor'}]","[{'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}]",[],,0.271786,,[],BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16082']
986,31520608,A factorial-design randomized controlled trial comparing misoprostol alone to Dilapan with misoprostol and comparing buccal to vaginal misoprostol for same-day cervical preparation prior to dilation & evacuation at 14 weeks 0 days-19 weeks 6 days gestation .,"OBJECTIVES


To compare procedure times following same-day cervical preparation using misoprostol 400 mcg alone or misoprostol 400 mcg plus hygroscopic dilators for dilation and evacuation (D&E) before 20 weeks gestation and to compare side effects of buccal and vaginal misoprostol administration.
STUDY DESIGN


We randomized women undergoing D&E at 14 weeks 0 days-19 weeks 6 days gestation to receive (1) hygroscopic dilators or not and (2) buccal or vaginal misoprostol using a 2 × 2 factorial design. We assessed two primary outcomes: (1) total procedure time, defined as time to insert hygroscopic dilators plus D&E time, and (2) side effects of misoprostol 4-6 h after initiation of cervical preparation using a 5-point Likert scale assessing nausea, emesis, diarrhea, chills and cramps.
RESULTS


We randomized 163 women and 161 completed the study. We completed all procedures in one day. Mean total procedure time was 14.0 and 10.8 min. with and without hygroscopic dilators (difference 3.2 minutes, 95% CI 1.7, 4.6). Mean D&E procedure time was 0.7 (95% CI -0.8, 2.1) min longer without hygroscopic dilators. Initial cervical dilation was 15.6 and 11.7 mm with and without hygroscopic dilators (difference 3.9 mm, 95% CI 3.1, 4.8). Participants receiving buccal misoprostol reported less chills (1.9) than women receiving vaginal misoprostol (2.3), p = 0.04.
CONCLUSIONS


Hygroscopic dilators with misoprostol requires more time and increases cervical dilation without shortening D&E time when used for cervical preparation 4-6 h prior to D&E before 20 weeks. Women receiving vaginal misoprostol may have more chills compared to buccal misoprostol.
IMPLICATIONS


Adding hygroscopic dilators to misoprostol for same day D&E procedures at less than 20 weeks gestation increases total intervention time without reducing D&E time and is less favored by patients. Clinical judgment requires balancing relative effectiveness with patient preference. Further studies should evaluate the side effect profile of vaginal misoprostol.",2019,"Participants receiving buccal misoprostol reported less chills (1.9) than women receiving vaginal misoprostol (2.3), p=.04.
","['women undergoing D&E at 14weeks 0days', '163 women and 161 completed the study', 'same-day cervical preparation prior to Dilation & Evacuation at 14weeks 0days to 19weeks 6days gestation']","['misoprostol 400 mcg alone or misoprostol 400 mcg plus hygroscopic dilators', 'buccal misoprostol', 'misoprostol', 'hygroscopic dilators or not and (2) buccal or vaginal misoprostol', 'vaginal misoprostol', 'Dilapan with misoprostol and comparing buccal to vaginal misoprostol']","['total intervention time', 'Initial cervical dilation', 'chills', 'Mean D&E procedure time', 'Mean total procedure time', 'total procedure time, defined as time to insert hygroscopic dilators plus D&E time, and (2) side effects of misoprostol 4-6h after initiation of cervical preparation using a 5-point Likert scale assessing nausea, emesis, diarrhea, chills and cramps']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0180431', 'cui_str': 'Dilator, device (physical object)'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0174425', 'cui_str': 'dilapan'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0085593', 'cui_str': 'Chills'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0180431', 'cui_str': 'Dilator, device (physical object)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1446787', 'cui_str': 'Cramping'}]",163.0,0.384578,"Participants receiving buccal misoprostol reported less chills (1.9) than women receiving vaginal misoprostol (2.3), p=.04.
","[{'ForeName': 'Jamilah M', 'Initials': 'JM', 'LastName': 'Shakir-Reese', 'Affiliation': 'MedStar Washington Hospital Center, 106 Irving St., Suite 4700, Washington, DC 20010, USA. Electronic address: jmshakir@gmail.com.'}, {'ForeName': 'Peggy P', 'Initials': 'PP', 'LastName': 'Ye', 'Affiliation': 'MedStar Washington Hospital Center, 106 Irving St., Suite 4700, Washington, DC 20010, USA.'}, {'ForeName': 'Jamila B', 'Initials': 'JB', 'LastName': 'Perritt', 'Affiliation': 'Planned Parenthood of Metropolitan Washington, DC, 1225 4th. St., NE, Washington, DC 20002, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Lotke', 'Affiliation': 'MedStar Washington Hospital Center, 106 Irving St., Suite 4700, Washington, DC 20010, USA; Georgetown University School of Medicine, 4000 Reservoir Rd NW, 120 Building D, Washington, DC 20007, USA.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Reeves', 'Affiliation': 'MedStar Washington Hospital Center, 106 Irving St., Suite 4700, Washington, DC 20010, USA; DuPont Clinic, 1120 19th St. NW, Suite 316, Washington, DC 20036, USA; Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St. Baltimore, MD 21205, USA.'}]",Contraception,['10.1016/j.contraception.2019.09.001']
987,32410259,Long-term results of the MCL01 phase II trial of rituximab plus HyperCVAD alternating with high-dose cytarabine and methotrexate for the initial treatment of patients with mantle cell lymphoma.,"Mantle cell lymphoma is a rare and incurable lymphoproliferative disorder. In the MCL01 trial, patients were treated with the R-HCVAD regimen [rituximab plus HyperCVAD (hyperfractionated cyclophosphamide, vincristine, doxorubicin, dexamethasone; R-CVAD) alternating with high-dose methotrexate and cytarabine (AM)] for four cycles followed by autologous stem cell transplantation (ASCT) for those who reached only a partial response. After a median follow-up of 10·5 years, we reported 10-year progression-free and overall survival rates of 35% and 61% respectively, with a 10-years cumulative incidence rate of second malignancies of 10·6%. Mature results of the MCL01 trial confirmed the efficacy of HyperCVAD-AM as a frontline regimen for younger patients (≤65 years).",2020,"After a median follow-up of 10·5 years, we reported 10-year progression-free and overall survival rates of 35% and 61% respectively, with a 10-years cumulative incidence rate of second malignancies of 10·6%.","['patients with mantle cell lymphoma', 'younger patients (≤65\xa0years']","['cytarabine and methotrexate', 'rituximab plus HyperCVAD (hyperfractionated cyclophosphamide, vincristine, doxorubicin, dexamethasone; R-CVAD) alternating with high-dose methotrexate and cytarabine (AM', 'autologous stem cell transplantation (ASCT', 'rituximab plus HyperCVAD', 'HyperCVAD-AM']",['10-year progression-free and overall survival rates'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0334634', 'cui_str': 'Mantle cell lymphoma'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0082139', 'cui_str': 'CVAD protocol'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0310082,"After a median follow-up of 10·5 years, we reported 10-year progression-free and overall survival rates of 35% and 61% respectively, with a 10-years cumulative incidence rate of second malignancies of 10·6%.","[{'ForeName': 'Fulvio', 'Initials': 'F', 'LastName': 'Massaro', 'Affiliation': 'Hematology, AUSL/IRCCS Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Stepanishyna', 'Affiliation': 'Research Department of Hemoblastosis Chemotherapy, National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Manni', 'Affiliation': 'CHIMOMO Department, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Luminari', 'Affiliation': 'Hematology, AUSL/IRCCS Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Galimberti', 'Affiliation': 'Division of Hematology, Department of Clinical and Experimental Medicine, University of Pisa, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Marcheselli', 'Affiliation': 'Fondazione Italiana Linfomi (FIL) Onlus, Modena, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Visco', 'Affiliation': 'Department of Medicine, Section of Hematology and Bone Marrow Transplant Unit, University of Verona, Verona, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Tecchio', 'Affiliation': 'Department of Medicine, Section of Hematology and Bone Marrow Transplant Unit, University of Verona, Verona, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Stelitano', 'Affiliation': 'Division of Haematology, Azienda Ospedaliera Bianchi-Melacrino-Morelli, Reggio Calabria, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Angrilli', 'Affiliation': 'Ematologia Ospedale Civile dello Spirito Santo, Pescara, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Petrini', 'Affiliation': 'Division of Hematology, Department of Clinical and Experimental Medicine, University of Pisa, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Merli', 'Affiliation': 'Hematology, AUSL/IRCCS Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Federico', 'Affiliation': 'CHIMOMO Department, University of Modena and Reggio Emilia, Modena, Italy.'}]",British journal of haematology,['10.1111/bjh.16714']
988,31226322,Tamoxifen for the prevention of unscheduled bleeding in new users of the levonorgestrel 52-mg intrauterine system: a randomized controlled trial.,"OBJECTIVE


To determine if a course of oral tamoxifen initiated following placement of a levonorgestrel 52-mg intrauterine system (IUS) reduces bleeding/spotting days over 30 days.
STUDY DESIGN


In this single-center, double-blind, placebo-controlled trial, we recruited women ages 15-45 years initiating the levonorgestrel 52-mg IUS. We randomized eligible women to tamoxifen 10 mg or placebo twice daily for 7 days starting 21 days after levonorgestrel 52-mg IUS insertion. Participants tracked bleeding/spotting days via daily electronic diaries for 30 days after starting drug treatment. We assessed participant satisfaction with their bleeding pattern and the IUS using a visual analog scale (0-100 mm). A sample size of 42 provided 80% power to detect a difference of 7 bleeding/spotting days in 30 days by two-sample t test, accounting for an expected 20% dropout rate.
RESULTS


From September 2016 to January 2018, 42 women enrolled. A total of 34 women provided complete bleeding/spotting data, and 30 women provided satisfaction data. Mean bleeding/spotting days over 30 days did not differ between tamoxifen (12.0±5.8 days) and placebo users (16.8±9.0 days), p=.08. We found no significant differences in mean satisfaction with bleeding profiles (51 mm tamoxifen vs. 59 mm placebo, p=.48) or with the IUS (83 mm vs. 75 mm, p=.36) between groups. Both groups reported similar rates of adverse events, with no serious adverse events reported.
CONCLUSION


A course of oral tamoxifen did not improve early breakthrough bleeding or satisfaction in new users of the levonorgestrel 52-mg IUS.
IMPLICATIONS


Although tamoxifen treatment caused a trend toward modest bleeding/spotting day reduction in new levonorgestrel 52-mg IUS users, bleeding satisfaction did not improve. Future studies of tamoxifen treatment for IUS-related bleeding issues may be best targeted toward users with ongoing bleeding irregularities or lower-dose IUS products which cause more bleeding irregularities.",2019,"A course of oral tamoxifen did not improve early breakthrough bleeding or satisfaction in new users of the levonorgestrel 52mg IUS.
","['new users of the Levonorgestrel 52mg intrauterine system', 'From September 2016 to January 2018, 42 women enrolled', '34 women provided complete bleeding/spotting data, and 30 women provided satisfaction data', 'recruited women ages 15-45years initiating the']","['Tamoxifen', 'placebo', 'levonorgestrel 52mg intrauterine system (IUS', 'levonorgestrel 52mg IUS insertion', 'levonorgestrel 52mg IUS', 'tamoxifen', 'tamoxifen 10mg or placebo', 'oral tamoxifen']","['bleeding/spotting days via daily electronic diaries', 'rates of adverse events', 'modest bleeding/spotting day reduction', 'Mean bleeding/spotting days over 30days', 'mean satisfaction with bleeding profiles', 'early breakthrough bleeding or satisfaction', 'unscheduled bleeding', 'bleeding satisfaction', 'participant satisfaction with their bleeding pattern and the IUS using a visual analog scale']","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0937459', 'cui_str': 'levonorgestrel 52 MG 5 Year Intrauterine System'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0937459', 'cui_str': 'levonorgestrel 52 MG 5 Year Intrauterine System'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1596572', 'cui_str': 'Tamoxifen 10 MG [Nolvadex]'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",42.0,0.675474,"A course of oral tamoxifen did not improve early breakthrough bleeding or satisfaction in new users of the levonorgestrel 52mg IUS.
","[{'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Cohen', 'Affiliation': 'Department of Obstetrics & Gynecology, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, UHN 50, Portland, Oregon 97239. Electronic address: mcohen82@jhu.edu.'}, {'ForeName': 'Katharine B', 'Initials': 'KB', 'LastName': 'Simmons', 'Affiliation': 'The Permanente Medical Group, Department of Obstetrics & Gynecology, 2500 Merced Street, San Leandro, CA 94577.'}, {'ForeName': 'Alison B', 'Initials': 'AB', 'LastName': 'Edelman', 'Affiliation': 'Department of Obstetrics & Gynecology, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, UHN 50, Portland, Oregon 97239.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Jensen', 'Affiliation': 'Department of Obstetrics & Gynecology, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, UHN 50, Portland, Oregon 97239.'}]",Contraception,['10.1016/j.contraception.2019.06.009']
989,13574863,A preliminary clinical trial of bacitracin and its combination with streptomycin in amebiasis.,,1958,,[],['bacitracin'],[],[],"[{'cui': 'C0004599', 'cui_str': 'Bacitracin'}]",[],,0.0266084,,"[{'ForeName': 'E R', 'Initials': 'ER', 'LastName': 'DEMELLO', 'Affiliation': ''}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'PATEL', 'Affiliation': ''}]",Indian journal of medical sciences,[]
990,31122797,Neurodevelopmental effects of ante-partum and post-partum antiretroviral exposure in HIV-exposed and uninfected children versus HIV-unexposed and uninfected children in Uganda and Malawi: a prospective cohort study.,"BACKGROUND


Antiretroviral medication during pregnancy and breastfeeding substantially decreases the risk of HIV transmission from mothers to infants, but its effects on the child's neurodevelopment are unknown. This study compared neurodevelopmental outcomes of ante-partum and post-partum antiretroviral exposure in HIV-exposed and uninfected children with HIV-unexposed and uninfected children at ages 12, 24, 48, and 60 months.
METHODS


For this study, a prospective cohort of HIV-exposed and uninfected children was identified from two research sites in the PROMISE-BF trial (at Blantyre, Malawi, and Kampala, Uganda), in which pregnant HIV-infected mothers were randomly assigned to triple antiretroviral prophylaxis (lopinavir-ritonavir plus either lamivudine and zidovudine or emtricitabine and tenofovir), versus zidovudine alone. Post partum, the mother-infant pairs were randomly assigned to maternal triple antiretroviral treatment or infant nevirapine during breastfeeding. HIV-unexposed and uninfected children matched for age, sex, and socioeconomic background were enrolled at vaccination and well-child clinics at the study sites. We included only children without a history of documented brain infection or injury or substantial malnutrition, and whose mothers were randomly assigned and maintained within their assigned ante-partum and post-partum phases throughout their treatment arm periods. Primary outcomes were the Mullen Scales of Early Learning (MSEL) cognitive composite score at age 12 months, 24 months, and 48 months; and the mental processing index for the Kaufman Assessment Battery for Children, second edition (KABC-II) global score at 48 months and 60 months. Repeated measures were analysed using a linear mixed-effects model controlling for data collection site.
FINDINGS


Between Aug 23, 2013, and Dec 17, 2014, we co-enrolled 861 children. For MSEL assessments, 738 were eligible for inclusion at age 12 months, 790 at age 24 months, and 692 at age 48 months. For KABC-II assessments, 685 were eligible for inclusion at age 48 months and 445 at age 60 months. There were no differences in MSEL cognitive composite scores according to exposure at age 12 and 24 months (p=0·19 and 0·24, respectively, for comparison of all groups). At 48 months, MSEL cognitive composite scores were worse for children of mothers who did not remain on triple antiretroviral treatment throughout both the ante-partum and post-partum treatment phases (adjusted means 80·64 [95% CI 77·74-83·54] and 81·34 [78·19-84·48], respectively), compared with those who did remain on triple treatment (adjusted mean 85·93, 95% CI 83·05-88·80; p=0·0486 for the comparison of all groups). The KABC-II composite scores (mental processing index) did not differ at 48 or 60 months according to exposure (p=0·81 and 0·89, respectively, for comparison of all groups). Scores for MSEL and KABC-II for children of mothers on triple antiretrovirals in both the ante-partum and post-partum treatment phases were similar to those for children in the HIV-unexposed and uninfected reference group at all timepoints.
INTERPRETATION


Maternal triple antiretroviral exposure during both the ante-partum and post-partum phases did not result in greater developmental risks for the mothers' HIV-exposed and uninfected children through age 60 months, compared with children who were HIV-unexposed and uninfected. This might be because ante-partum triple antiretroviral protection of the health of mothers with HIV during pregnancy might be neuroprotective for the child, and when continued post partum, could enhance the quality of caregiving for the child through better clinical care for the mother.
FUNDING


National Institutes of Health and Eunice Kennedy Shriver National Institute of Child Health and Human Development.",2019,"At 48 months, MSEL cognitive composite scores were worse for children of mothers who did not remain on triple antiretroviral treatment throughout both the ante-partum and post-partum treatment phases (adjusted means 80·64","['children without a history of documented brain infection or injury or substantial malnutrition, and whose mothers', 'Between Aug 23, 2013, and Dec 17, 2014, we co-enrolled 861 children', 'HIV-unexposed and uninfected children matched for age, sex, and socioeconomic background were enrolled at vaccination and well-child clinics at the study sites', 'HIV-exposed and uninfected children versus HIV-unexposed and uninfected children in Uganda and Malawi', '738 were eligible for inclusion at age 12 months, 790 at age 24 months, and 692 at age 48 months', 'pregnant HIV-infected mothers', '685 were eligible for inclusion at age 48 months and 445 at age 60 months', 'HIV-exposed and uninfected children with HIV-unexposed and uninfected children at ages 12, 24, 48, and 60 months', 'mother-infant pairs']","['maternal triple antiretroviral treatment or infant nevirapine', 'zidovudine alone', 'ante-partum and post-partum antiretroviral exposure', 'triple antiretroviral prophylaxis (lopinavir-ritonavir plus either lamivudine and zidovudine or emtricitabine and tenofovir']","['KABC-II composite scores (mental processing index', 'mental processing index for the Kaufman Assessment Battery for Children, second edition (KABC-II) global score', 'Mullen Scales of Early Learning (MSEL) cognitive composite score', 'MSEL cognitive composite scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0582638', 'cui_str': 'Kaufman assessment battery for children (assessment scale)'}, {'cui': 'C0441795', 'cui_str': 'Second edition (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",861.0,0.101645,"At 48 months, MSEL cognitive composite scores were worse for children of mothers who did not remain on triple antiretroviral treatment throughout both the ante-partum and post-partum treatment phases (adjusted means 80·64","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Boivin', 'Affiliation': 'Department of Psychiatry, Michigan State University, East Lansing, MI, USA; Department of Neurology & Ophthalmology, Michigan State University, East Lansing, MI, USA; Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA. Electronic address: boivin@msu.edu.'}, {'ForeName': 'Limbika', 'Initials': 'L', 'LastName': 'Maliwichi-Senganimalunje', 'Affiliation': 'Malawi College of Medicine, Johns Hopkins University Research Project, Blantyre, Malawi; Department of Psychology, Chancellor College, University of Malawi, Zomba, Malawi.'}, {'ForeName': 'Lillian W', 'Initials': 'LW', 'LastName': 'Ogwang', 'Affiliation': 'Department of Psychology, Chancellor College, University of Malawi, Zomba, Malawi.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kawalazira', 'Affiliation': 'Malawi College of Medicine, Johns Hopkins University Research Project, Blantyre, Malawi.'}, {'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Sikorskii', 'Affiliation': 'Department of Psychiatry, Michigan State University, East Lansing, MI, USA; Department of Statistics & Probability, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Familiar-Lopez', 'Affiliation': 'Department of Psychiatry, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Agatha', 'Initials': 'A', 'LastName': 'Kuteesa', 'Affiliation': 'Makerere University-Johns Hopkins University, Kampala, Uganda.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Nyakato', 'Affiliation': 'Makerere University-Johns Hopkins University, Kampala, Uganda.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Mutebe', 'Affiliation': 'Makerere University-Johns Hopkins University, Kampala, Uganda.'}, {'ForeName': 'Jackie L', 'Initials': 'JL', 'LastName': 'Namukooli', 'Affiliation': 'Makerere University-Johns Hopkins University, Kampala, Uganda.'}, {'ForeName': 'MacPherson', 'Initials': 'M', 'LastName': 'Mallewa', 'Affiliation': 'Malawi College of Medicine, Johns Hopkins University Research Project, Blantyre, Malawi.'}, {'ForeName': 'Horacio', 'Initials': 'H', 'LastName': 'Ruiseñor-Escudero', 'Affiliation': 'Department of Psychiatry, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Aizire', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Taha E', 'Initials': 'TE', 'LastName': 'Taha', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Mary G', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Department of Pathology, Johns Hopkins University Medical Institute, Baltimore, MD, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(19)30083-9']
991,30846659,"Does the chromagen blue filter lens affect the reading speed, accuracy and contrast sensitivity.","PURPOSE


To determine the effects of ChromaGen blue filter lens in reading speed, accuracy and contrast sensitivity.
METHODS


A cross-over, randomised study was carried out on 40 individuals (11 males and 29 females) aged 21 to 30 years. The rate of reading and reading accuracy was calculated with and without ChromaGen blue filter lens in all subjects. Wilkins Rate of Reading Test was used to measure the rate of reading and reading accuracy. Contrast sensitivity was also evaluated by using with and without the ChromaGen blue filter lens.
RESULTS


The mean rate of reading with and without ChromaGen blue filter lens was 160.58±16.03 words per minute and 150.52±15.66 words per minute respectively, with significant difference of p<0.001. The mean of reading accuracy (words correctly read per minute) in subjects, with ChromaGen blue filter was 149.30±0.79 words and without using filter lens was 148.53±1.11 words and found to be significant (p<0.001). There was no significant difference in the contrast sensitivity between subjects with and without the ChromaGen blue filter lens (p=0.083). No significant correlation was noted between the reading speed with age, spherical equivalent, contrast sensitivity, and reading accuracy.
CONCLUSION


This study concludes that there was an increase of 6.68% in the rate of reading and improvement of 0.52% in accuracy among subjects with ChromaGen blue filter lens.",2019,There was no significant difference in the contrast sensitivity between subjects with and without the ChromaGen blue filter lens (p=0.083).,"['subjects with ChromaGen blue filter lens', '40 individuals (11 males and 29 females) aged 21 to 30 years']",['ChromaGen blue filter lens'],"['reading speed, accuracy and contrast sensitivity', 'Contrast sensitivity', 'contrast sensitivity', 'mean of reading accuracy', 'rate of reading and reading accuracy', 'reading speed with age, spherical equivalent, contrast sensitivity, and reading accuracy', 'Wilkins Rate of Reading Test', 'mean rate of reading with and without ChromaGen blue filter lens']","[{'cui': 'C1260957', 'cui_str': 'Blue color (qualifier value)'}, {'cui': 'C0180860', 'cui_str': 'Filter, device (physical object)'}, {'cui': 'C0023317', 'cui_str': 'Lens, Eye'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1260957', 'cui_str': 'Blue color (qualifier value)'}, {'cui': 'C0180860', 'cui_str': 'Filter, device (physical object)'}, {'cui': 'C0023317', 'cui_str': 'Lens, Eye'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0009928', 'cui_str': 'Visual Contrast Sensitivity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1260957', 'cui_str': 'Blue color (qualifier value)'}, {'cui': 'C0180860', 'cui_str': 'Filter, device (physical object)'}, {'cui': 'C0023317', 'cui_str': 'Lens, Eye'}]",40.0,0.0206116,There was no significant difference in the contrast sensitivity between subjects with and without the ChromaGen blue filter lens (p=0.083).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': 'UCSI University, Taman Connaught, Kuala Lumpur, Malaysia. madhavendra_opto@yahoo.co.in.'}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Wei Ern', 'Affiliation': 'Twintech International University Collage of Technology, Kuala Lumpur, Malaysia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Majumder', 'Affiliation': 'UCSI University, Taman Connaught, Kuala Lumpur, Malaysia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ho', 'Affiliation': 'Twintech International University Collage of Technology, Kuala Lumpur, Malaysia.'}]",The Medical journal of Malaysia,[]
992,32410260,The simplified follicular lymphoma PRIMA-prognostic index is useful in patients with first-line chemo-free rituximab-based therapy.,"Follicular lymphoma (FL) is a heterogeneous disease; therefore, reliable prognostic tools are needed to plan treatment strategies. The FL International Prognostic Index (FLIPI) was developed before the rituximab era, while the PRIMA-PI was built on rituximab chemotherapy. Our objective was to evaluate these two prognostic tools in a cohort of 291 patients with FL treated in two prospective randomised Nordic Lymphoma Group trials with rituximab ± interferon. All patients had symptomatic/progressive disease and were previously untreated. The PRIMA-PI was prognostic for both time to treatment failure (TTF) and overall survival (OS) (log-rank P = 0·003 and P < 0·001, respectively). The PRIMA-PI high-risk identified a small group of patients with a very short TTF and OS compared to the low-risk group, with a hazard ratio (HR) of 1·90 (95% confidence interval [CI] 1·30-2·78, P = 0·001) and HR of 3·19 (95% CI 1·75-5·83, P < 0·001), respectively. The FLIPI risk groups were prognostic only for OS (log-rank P = 0·018). The simplified PRIMA-PI was valid in our FL cohort with first-line rituximab-containing chemo-free therapy and shows an improved risk stratification compared to the FLIPI, especially in patients aged >60 years. Patients in the PRIMA-PI high-risk group should be considered for alternative therapies.",2020,The PRIMA-PI was prognostic for both time to treatment failure (TTF) and overall survival (OS) (log-rank P = 0·003 and P ,"['291 patients with FL', 'patients aged >60\xa0years', 'All patients had symptomatic/progressive disease and were previously untreated', 'patients with first-line chemo-free rituximab-based therapy']",['rituximab\xa0±\xa0interferon'],"['overall survival (OS', 'FL International Prognostic Index (FLIPI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4040298', 'cui_str': 'Follicular Lymphoma International Prognostic Index'}, {'cui': 'C1512894', 'cui_str': 'International Prognostic Index'}]",291.0,0.0482468,The PRIMA-PI was prognostic for both time to treatment failure (TTF) and overall survival (OS) (log-rank P = 0·003 and P ,"[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kimby', 'Affiliation': 'Unit of Hematology, Department of Medicine at Huddinge, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Lockmer', 'Affiliation': 'Unit of Hematology, Department of Medicine at Huddinge, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Holte', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Hagberg', 'Affiliation': 'Department of Oncology, Academic Hospital, Uppsala, Sweden.'}, {'ForeName': 'Björn E', 'Initials': 'BE', 'LastName': 'Wahlin', 'Affiliation': 'Unit of Hematology, Department of Medicine at Huddinge, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brown', 'Affiliation': 'Department of Hematology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Østenstad', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}]",British journal of haematology,['10.1111/bjh.16692']
993,32409981,Intravenous Tramadol is Effective in the Management of Postoperative Pain Following Abdominoplasty: A Three-Arm Randomized Placebo- and Active-Controlled Trial.,"BACKGROUND AND OBJECTIVE


Oral tramadol, an atypical opioid approved in the United States (US) since 1995 and a Schedule IV controlled substance, has less abuse liability compared to Schedule II conventional opioids. Intravenous (IV) tramadol is not available in the US, but has the potential to fill a gap between non-opioid medications and conventional opioids for treatment of acute pain. This study evaluates IV tramadol in the management of postoperative pain compared to placebo and standard-of-care active control.
METHODS


A phase 3, multicenter, double-blind, three-arm, randomized, placebo- and active-controlled, multiple-dose, parallel-group study was conducted to evaluate the efficacy and safety of 50 mg IV tramadol versus placebo and 4 mg IV morphine over 48 h in patients with postoperative pain following abdominoplasty surgery.
RESULTS


IV tramadol was statistically superior (p < 0.05) to placebo and comparable to IV morphine for the primary and all key secondary efficacy outcomes and demonstrated numerically lower rates for the incidence of most common treatment-emergent adverse events (TEAEs) compared to morphine. No unexpected findings were observed for TEAEs, laboratory tests, vital signs, or electrocardiograms (ECGs). Over 90% of patients completed the study.
CONCLUSION


The study demonstrated that IV tramadol 50 mg is highly effective in the management of postoperative pain following abdominoplasty. The consistency of effects between tramadol and morphine (as compared to placebo) for primary and key secondary endpoints validates the efficacy of tramadol observed. The study also provided direct evidence of improved tolerability of IV tramadol over a standard-of-care conventional Schedule II opioid. IV tramadol may become a useful option in patients where exposure to conventional opioids is not desired.",2020,"RESULTS


IV tramadol was statistically superior (p < 0.05) to placebo and comparable to IV morphine for the primary and all key secondary efficacy outcomes and demonstrated numerically lower rates for the incidence of most common treatment-emergent adverse events (TEAEs) compared to morphine.",['patients with postoperative pain following abdominoplasty surgery'],"['Placebo', 'IV tramadol', 'placebo and standard-of-care active control', 'morphine', 'Abdominoplasty', 'tramadol', '50\xa0mg IV tramadol versus placebo and 4\xa0mg IV morphine', 'Intravenous Tramadol', 'Intravenous (IV) tramadol', 'tramadol and morphine', 'placebo']","['Postoperative Pain', 'postoperative pain', 'TEAEs, laboratory tests, vital signs, or electrocardiograms (ECGs', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.353103,"RESULTS


IV tramadol was statistically superior (p < 0.05) to placebo and comparable to IV morphine for the primary and all key secondary efficacy outcomes and demonstrated numerically lower rates for the incidence of most common treatment-emergent adverse events (TEAEs) compared to morphine.","[{'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Minkowitz', 'Affiliation': 'Clinical Investigation, HD Research, LLC, Bellaire, TX, USA.'}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Salazar', 'Affiliation': 'Clinical Investigation, Endeavor Clinical Trials, HD, San Antonio, TX, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leiman', 'Affiliation': 'Clinical Investigation, HD Research, LLC, Bellaire, TX, USA.'}, {'ForeName': 'Daneshvari', 'Initials': 'D', 'LastName': 'Solanki', 'Affiliation': 'Clinical Investigation, HD Research, LLC, Bellaire, TX, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Clinical Research, Avenue Therapeutics, 1140 Avenue of the Americas, 9th Floor, New York, NY, 10036, USA. llu@avenuetx.com.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Reines', 'Affiliation': 'Clinical Research, Avenue Therapeutics, 1140 Avenue of the Americas, 9th Floor, New York, NY, 10036, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ryan', 'Affiliation': 'Clinical Research, Avenue Therapeutics, 1140 Avenue of the Americas, 9th Floor, New York, NY, 10036, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Harnett', 'Affiliation': 'Clinical Research, Avenue Therapeutics, 1140 Avenue of the Americas, 9th Floor, New York, NY, 10036, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Singla', 'Affiliation': 'Clinical Investigation, Lotus Clinical Research, LLC, Pasadena, CA, USA.'}]",Drugs in R&D,['10.1007/s40268-020-00309-0']
994,30846665,A cluster randomised controlled trial on effectiveness of carbon monoxide measurement feedback among college smoker : A study protocol.,"INTRODUCTION


For the last 30 years, tobacco smoking has continued to be the leading cause of premature deaths in Malaysia. Majority of the smokers in Malaysia are at the precontemplation and contemplation stages. Therefore, for the purpose of increasing smoking cessation among this group, the strategies that motivate them to quit smoking have to be reviewed.
OBJECTIVE


This study aims to evaluate the effectiveness of carbon monoxide measurement feedback and the standard brief motivation adopted to encourage the smoker to quit.
METHODS


A single-blind, cluster randomised controlled trial was conducted at ten tertiary colleges in Selangor. The study recruited young adult smokers at the precontemplation and contemplation stages. The subjects in the control group received a standard brief motivational strategy. On the other hand, the intervention group received additional carbon monoxide measurement and a motivational feedback module. A follow up was conducted at the first, third and sixth month to measure changes in smoking cessation stage. Subsequently, the secondary outcomes of a mean number of cigarette consumption and quit smoking attempt were analysed. A total of 160 subjects were required to detect the expected difference of 17% in primary outcomes between the groups. This study utilised Generalised Estimating Equations (GEE) to handle the clustering effects.
CONCLUSION


Biomedical risk assessment feedback mechanism by using carbon monoxide is a promising aid to motivate the smoker to quit. This mechanism is a relatively easy, quick and non-invasive technique. Thus, it can be utilised as a reinforcement relating to the harmful effect of smoking. Besides, it can also increase the smokers' selfefficacy and decisional balance to adopt behavioural changes.",2019,"Therefore, for the purpose of increasing smoking cessation among this group, the strategies that motivate them to quit smoking have to be reviewed.
","['young adult smokers at the precontemplation and contemplation stages', 'ten tertiary colleges in Selangor', '160 subjects', 'college smoker ']","['carbon monoxide measurement feedback', 'standard brief motivational strategy', 'additional carbon monoxide measurement and a motivational feedback module']","['mean number of cigarette consumption and quit smoking attempt', 'smoking cessation stage', ""smokers' selfefficacy and decisional balance""]","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1277196', 'cui_str': 'Contemplation stage'}, {'cui': 'C0557807', 'cui_str': 'Tertiary college (environment)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}]","[{'cui': 'C0201932', 'cui_str': 'Carboxyhemoglobin measurement (procedure)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption (observable entity)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",160.0,0.0282442,"Therefore, for the purpose of increasing smoking cessation among this group, the strategies that motivate them to quit smoking have to be reviewed.
","[{'ForeName': 'Z A', 'Initials': 'ZA', 'LastName': 'Muhammad Aidil', 'Affiliation': 'Universiti Putra Malaysia, Faculty of Medicine and Health Sciences, Department of Community Health, Serdang, Selangor, Malaysia. adilzainal@gmail.com.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hayati', 'Affiliation': 'Universiti Putra Malaysia, Faculty of Medicine and Health Sciences, Department of Community Health, Serdang, Selangor, Malaysia.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Rosliza', 'Affiliation': 'Universiti Putra Malaysia, Faculty of Medicine and Health Sciences, Department of Community Health, Serdang, Selangor, Malaysia.'}]",The Medical journal of Malaysia,[]
995,32410362,Combination of oral methotrexate and oral mini-pulse dexamethasone versus either agent alone in vitiligo treatment with follow up by dermoscope.,"This study aimed to compare the efficacy and safety of oral methotrexate (MTX) and oral mini-pulse (OMP) dexamethasone alone and in combination in the treatment of vitiligo. PATIENTS AND METHODS: A total of 42 patients with vitiligo were included in the study. The patients were treated for three months and randomly assigned into three groups including 14 patients each: group A received oral MTX, group B received OMP dexamethasone, and group C received a combination of both. Follow-up was performed using digital photographs, Vitiligo European Task Force score, and dermoscopy. RESULTS: Disease extension significantly decreased in group C compared with that in groups A (p < 0.001) and B (p < 0.05). The frequency of intralesional pigmentation significantly increased (p < 0.05) in groups A and C and decreased (p < 0.05) in group B posttreatment noted using a dermoscope. Moreover, the frequency of micro-Koebner's phenomenon and starburst pattern significantly decreased (p < 0.05) in groups B and C and that of tapioca sago in group C only posttreatment. This article is protected by copyright. All rights reserved.",2020,Disease extension significantly decreased in group C compared with that in groups A (p < 0.001) and B (p < 0.05).,"['42 patients with vitiligo were included in the study', 'vitiligo']","['oral methotrexate (MTX) and oral mini-pulse (OMP) dexamethasone', 'oral methotrexate and oral mini-pulse dexamethasone', 'oral MTX', 'OMP dexamethasone']","[""frequency of micro-Koebner's phenomenon and starburst pattern"", 'efficacy and safety', 'Disease extension', 'frequency of intralesional pigmentation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0263367', 'cui_str': 'Köbner phenomenon'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}]",42.0,0.0246827,Disease extension significantly decreased in group C compared with that in groups A (p < 0.001) and B (p < 0.05).,"[{'ForeName': 'Mohamed Ibrahim', 'Initials': 'MI', 'LastName': 'ElGhareeb', 'Affiliation': 'Consultant and Lecturer of Dermatology at Faculty of Medicine Zagazig University, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Metwally', 'Affiliation': 'Professor of Dermatology at Faculty of Medicine Zagazig University, Egypt.'}, {'ForeName': 'Nehal', 'Initials': 'N', 'LastName': 'AbdelMoneim', 'Affiliation': 'Resident Dermatologist.'}]",Dermatologic therapy,['10.1111/dth.13586']
996,32409982,"A Phase 1, Randomised, Placebo-Controlled, Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Cannabidiol in Fed Healthy Volunteers.","BACKGROUND


There is increasing interest in the use of purified cannabidiol (CBD) as a treatment for a wide range of conditions due to its reported anti-inflammatory, anxiolytic, antiemetic and anticonvulsant properties.
OBJECTIVE


The objective of this study was to assess the safety, tolerability and pharmacokinetics of a single ascending dose of a new lipid-based oral formulation of CBD in healthy volunteers after a high-fat meal.
METHODS


A total of 24 eligible healthy volunteers (aged 18-48 years) were randomised to one of three sequential cohorts (each with six active  and two placebo subjects). Cohort 1 received 5 mg/kg CBD or placebo, cohort 2 received 10 mg/kg CBD or placebo (cohort 2), and cohort 3 received 20 mg/kg CBD or placebo. Data relating to adverse events, vital signs, clinical laboratory assessments, 12-lead ECGs, physical examinations and concomitant medications were collected to assess safety and tolerability. Blood samples were collected up to 8 days postdose and plasma was analysed by liquid chromatography and mass spectrometry to assess the pharmacokinetics of the CBD formulation.
RESULTS


CBD was well tolerated in the healthy volunteers (mean age: 24.0 years) treated with a single oral dose of CBD. There were no safety concerns with increasing the dose and the safety profiles of the CBD-treated and placebo-treated subjects were similar. The most frequently reported treatment emergent adverse events (TEAEs) were headache (17%) and diarrhoea (8%). There were no reported serious adverse events (SAEs) and no clinical laboratory findings, vital signs, ECGs or physical examination findings that were reported as TEAEs or were of clinical significance during the study. After a high-fat meal, CBD was detected in plasma samples at 15 min postdose; the median time to maximum plasma concentration (T max ) was 4 h across all three CBD dose cohorts. The CBD plasma exposure [maximum observed plasma concentration (C max ) and the area under the concentration-time curve (AUC)] increased in a dose-proportional manner and declined to levels approaching the lower level of quantification by day 8. The terminal elimination half-life was approximately 70 h, suggesting that 2-3 weeks are needed to fully eliminate CBD.
CONCLUSIONS


This new CBD formulation demonstrated a favourable safety and tolerability profile in healthy volunteers that was consistent with the profiles reported for other purified CBD products. No severe or serious AEs were observed in this study and there were no safety concerns.
TRIAL REGISTRATION


ACTRN12618001424291. Registered August 2018.",2020,There were no safety concerns with increasing the dose and the safety profiles of the CBD-treated and placebo-treated subjects were similar.,"['Fed Healthy Volunteers', 'healthy volunteers', 'healthy volunteers (mean age: 24.0\xa0years', '24 eligible healthy volunteers (aged 18-48\xa0years', 'healthy volunteers after a high-fat meal']","['new lipid-based oral formulation of CBD', 'Placebo', '10\xa0mg/kg CBD or placebo', '5\xa0mg/kg CBD or placebo', '20\xa0mg/kg CBD or placebo', 'purified cannabidiol (CBD', 'placebo']","['headache', 'Safety, Tolerability and Pharmacokinetics of Cannabidiol', 'safety profiles', 'adverse events, vital signs, clinical laboratory assessments, 12-lead ECGs, physical examinations and concomitant medications', 'tolerated', 'safety, tolerability and pharmacokinetics', 'median time to maximum plasma concentration (T max ', 'safety and tolerability', 'diarrhoea', 'severe or serious AEs', 'safety and tolerability profile', 'serious adverse events (SAEs) and no clinical laboratory findings, vital signs, ECGs or physical examination findings', 'CBD plasma exposure [maximum observed plasma concentration (C max ) and the area under the concentration-time curve (AUC']","[{'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",24.0,0.234806,There were no safety concerns with increasing the dose and the safety profiles of the CBD-treated and placebo-treated subjects were similar.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Perkins', 'Affiliation': 'Department of Health and Human Services, Office of Medicinal Cannabis, 50 Lonsdale St, Melbourne, VIC, 3000, Australia. daniel.perkins@dhhs.vic.gov.au.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Health and Human Services, Office of Medicinal Cannabis, 50 Lonsdale St, Melbourne, VIC, 3000, Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Ong', 'Affiliation': 'Department of Health and Human Services, Office of Medicinal Cannabis, 50 Lonsdale St, Melbourne, VIC, 3000, Australia.'}, {'ForeName': 'Tri-Hung', 'Initials': 'TH', 'LastName': 'Nguyen', 'Affiliation': 'Medicines Manufacturing Innovation Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Cox', 'Affiliation': 'Neuroscience Trials Australia, Heidelberg, VIC, Australia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Francis', 'Affiliation': 'Avance Clinical, Thebarton, SA, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Mcintosh', 'Affiliation': 'Medicines Manufacturing Innovation Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lilley', 'Affiliation': ""Royal Children's Hospital, Parkville, VIC, Australia.""}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-020-00624-6']
997,30855708,"[Efficacy and safety of transcranial magnetic stimulation in patients with non-fluent aphasia, following an ischaemic stroke. A controlled, randomised and double-blind clinical trial].","INTRODUCTION


Non-fluent aphasia is a frequent complication in post-ischemic stroke patients, with repetitive transcranial magnetic stimulation (rTMS) being one of the possible treatment alternatives.
AIM


To assess the efficacy and safety of rTMS in patients with non-fluent after-ischemic stroke aphasia.
PATIENTS AND METHODS


Double blind, randomized controlled clinical trial in post-stroke patients who were assigned to receive 10 sessions (one daily) of active treatment or placebo of rTMS, without the addition of language therapy. The baseline characteristics were compared initially and the efficacy between the active group versus the placebo group at day 30 was evaluated through a Mann-Whitney U test.
RESULTS


82 patients were included: active group (n = 41) and placebo group (n = 41). At baseline, statistically significant differences were found between the groups in favor of the placebo in the domains of the Boston test of auditory compression (p = 0.024), denomination (p = 0.014) and praxis (p = 0.026), and also occurred on the 30th day in the naming domains (p = 0.037) and reading (p = 0.001). There were 39 adverse reactions: 23 (26.83%) in the active group vs 16 (21.96%) in the placebo group (p = 0.290); the majority corresponded to episodes of mild headache.
CONCLUSION


rTMS is a safe therapy, however, given the conditions of this study, we could not demonstrate the efficacy of rTMS versus placebo in patients with non-fluent aphasia with involvement of Broca's area after an ischemic stroke.",2019,"At baseline, statistically significant differences were found between the groups in favor of the placebo in the domains of the Boston test of auditory compression (p = 0.024), denomination (p = 0.014) and praxis (p = 0.026), and also occurred on the 30th day in the naming domains (p = 0.037) and reading (p = 0.001).","['post-stroke patients', ""patients with non-fluent aphasia with involvement of Broca's area after an ischemic stroke"", '82 patients were included: active group (n = 41) and', 'patients with non-fluent after-ischemic stroke aphasia', 'patients with non-fluent aphasia, following an ischaemic stroke']","['placebo', 'active treatment or placebo of rTMS, without the addition of language therapy', 'transcranial magnetic stimulation', 'repetitive transcranial magnetic stimulation (rTMS', 'rTMS', 'rTMS versus placebo']","['Boston test of auditory compression', 'efficacy and safety']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0349390', 'cui_str': 'Non-fluent aphasia'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0006208', 'cui_str': ""Broca's Region""}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023017', 'cui_str': 'Language Therapy'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",82.0,0.554684,"At baseline, statistically significant differences were found between the groups in favor of the placebo in the domains of the Boston test of auditory compression (p = 0.024), denomination (p = 0.014) and praxis (p = 0.026), and also occurred on the 30th day in the naming domains (p = 0.037) and reading (p = 0.001).","[{'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Lopez-Romero', 'Affiliation': 'Hospital Internacional de Colombia, Bucaramanga, Colombia.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Riano-Carreno', 'Affiliation': 'Hospital Internacional de Colombia, Bucaramanga, Colombia.'}, {'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Pachon-Poveda', 'Affiliation': 'Hospital Internacional de Colombia, Bucaramanga, Colombia.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Mendoza-Sanchez', 'Affiliation': 'Hospital Internacional de Colombia, Bucaramanga, Colombia.'}, {'ForeName': 'Y K', 'Initials': 'YK', 'LastName': 'Leon-Vargas', 'Affiliation': 'Universidad Pontificia Bolivariana, Bucaramanga, Colombia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moreno-Pabon', 'Affiliation': 'Hospital Internacional de Colombia, Bucaramanga, Colombia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Trillos-Leal', 'Affiliation': 'Hospital Internacional de Colombia, Bucaramanga, Colombia.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Garcia-Gomez', 'Affiliation': 'Hospital Internacional de Colombia, Bucaramanga, Colombia.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Rueda-Guzman', 'Affiliation': 'Hospital Internacional de Colombia, Bucaramanga, Colombia.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Silva', 'Affiliation': 'Hospital Internacional de Colombia, Bucaramanga, Colombia.'}]",Revista de neurologia,['10.33588/rn.6806.2018300']
998,32410404,"Human Recombinant Apyrase Therapy Protects Against Myocardial Ischemia/Reperfusion Injury and Preserves Left Ventricular Systolic Function in Rats, as Evaluated by 7T Cardiovascular Magnetic Resonance Imaging.","OBJECTIVE


The occurrence of intramyocardial hemorrhage (IMH) and microvascular obstruction (MVO) in myocardial infarction (MI), known as severe ischemia/reperfusion injury (IRI), has been associated with adverse remodeling. APT102, a soluble human recombinant ecto-nucleoside triphosphate diphosphohydrolase-1, can hydrolyze extracellular nucleotides to attenuate their prothrombotic and proinflammatory effects. The purpose of this study was to temporally evaluate the therapeutic effect of APT102 on IRI in rats and to elucidate the evolution of IRI in the acute stage using cardiovascular magnetic resonance imaging (CMRI).
MATERIALS AND METHODS


Fifty-four rats with MI, induced by ligation of the origin of the left anterior descending coronary artery for 60 minutes, were randomly divided into the APT102 (n = 27) or control (n = 27) group. Intravenous infusion of APT102 (0.3 mg/kg) or placebo was administered 15 minutes before reperfusion, and then 24 hours, 48 hours, 72 hours, and on day 4 after reperfusion. CMRI was performed at 24 hours, 48 hours, 72 hours, and on day 5 post-reperfusion using a 7T system and the hearts were collected for histopathological examination. Cardiac function was quantified using cine imaging and IMH/edema using T2 mapping, and infarct/MVO using late gadolinium enhancement.
RESULTS


The extent of infarction ( p  < 0.001), edema ( p  < 0.001), IMH ( p  = 0.013), and MVO ( p  = 0.049) was less severe in the APT102 group than in the control group. IMH size at 48 hours was significantly greater than that at 24 hours, 72 hours, and 5 days after reperfusion (all  p  < 0.001). The left ventricular ejection fraction (LVEF) was significantly greater in the APT102 group than in the control group ( p  = 0.006). There was a negative correlation between LVEF and IMH ( r  = -0.294,  p  = 0.010) and a positive correlation between IMH and MVO ( r  = 0.392,  p  < 0.001).
CONCLUSION


APT102 can significantly alleviate damage to the ischemic myocardium and microvasculature. IMH size peaked at 48 hours post reperfusion and IMH is a downstream consequence of MVO. IMH may be a potential therapeutic target to prevent adverse remodeling in MI.",2020,"IMH size at 48 hours was significantly greater than that at 24 hours, 72 hours, and 5 days after reperfusion (all  p  < 0.001).","['Fifty-four rats with MI, induced by ligation of the origin of the left anterior descending coronary artery for 60 minutes']","['IMH', 'APT102', 'Human Recombinant Apyrase Therapy', 'placebo']","['intramyocardial hemorrhage (IMH) and microvascular obstruction (MVO', 'Cardiac function', 'LVEF and IMH', 'edema', 'IMH', 'Left Ventricular Systolic Function', 'MVO', 'left ventricular ejection fraction (LVEF', 'IMH size']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0226032', 'cui_str': 'Structure of anterior descending branch of left coronary artery'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0003652', 'cui_str': 'Apyrase'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",54.0,0.0676234,"IMH size at 48 hours was significantly greater than that at 24 hours, 72 hours, and 5 days after reperfusion (all  p  < 0.001).","[{'ForeName': 'Ziqian', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital of Kunming Medical College, Kunming, China.'}, {'ForeName': 'Ruzhi', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Ridong', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'APT Therapeutics Inc., St Louis, MO, USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Fabao', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China. gaofabao@wchscu.cn.'}]",Korean journal of radiology,['10.3348/kjr.2019.0853']
999,31206613,N-Acetyl Cysteine Is Associated With Dopaminergic Improvement in Parkinson's Disease.,"This study assessed the biological and clinical effects in patients with Parkinson's disease (PD) of N-acetyl-cysteine (NAC), the prodrug to l-cysteine, a precursor to the natural biological antioxidant glutathione. Forty-two patients with PD were randomized to either weekly intravenous infusions of NAC (50 mg/kg) plus oral doses (500 mg twice per day) for 3 months or standard of care only. Participants received prebrain and postbrain imaging with ioflupane (DaTscan) to measure dopamine transporter (DAT) binding. In the NAC group, significantly increased DAT binding was found in the caudate and putamen (mean increase from 3.4% to 8.3%) compared with controls (P < 0.05), along with significantly improved PD symptoms (P < 0.0001). The results suggest NAC may positively affect the dopaminergic system in patients with PD, with corresponding positive clinical effects. Larger scale studies are warranted.",2019,"In the NAC group significantly increased DAT binding was found in the caudate and putamen (mean increase from 3.4% to 8.3%) compared to controls (p<0.05), along with significantly improved PD symptoms (p<0.0001).","['Forty-two patients with PD', ""patients with Parkinson's disease (PD) of N-acetyl-cysteine (NAC""]","['pre and post brain imaging with ioflupane (DaTscan) to measure dopamine transporter (DAT) binding', 'NAC', 'N-Acetyl Cysteine']","['PD symptoms', 'DAT binding', 'dopaminergic system']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C1956795', 'cui_str': '8-azabicyclo(3,2,1)octane-2-carboxylic acid, 8-(3-fluoropropyl)-3-(4-iodophenyl)-, methyl ester, (1R-(exo,exo))-'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0114838', 'cui_str': 'Dopamine Plasma Membrane Transport Proteins'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",42.0,0.0451377,"In the NAC group significantly increased DAT binding was found in the caudate and putamen (mean increase from 3.4% to 8.3%) compared to controls (p<0.05), along with significantly improved PD symptoms (p<0.0001).","[{'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Monti', 'Affiliation': 'Department of Integrative Medicine and Nutritional Sciences, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Zabrecky', 'Affiliation': 'Department of Integrative Medicine and Nutritional Sciences, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kremens', 'Affiliation': ""Department of Neurology, Jefferson Comprehensive Parkinson's Disease and Movement Disorders Center, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Tsao-Wei', 'Initials': 'TW', 'LastName': 'Liang', 'Affiliation': ""Department of Neurology, Jefferson Comprehensive Parkinson's Disease and Movement Disorders Center, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Wintering', 'Affiliation': 'Department of Integrative Medicine and Nutritional Sciences, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Bazzan', 'Affiliation': 'Department of Integrative Medicine and Nutritional Sciences, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'Marcus Institute of Integrative Health, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Brendan K', 'Initials': 'BK', 'LastName': 'Bowens', 'Affiliation': 'Marcus Institute of Integrative Health, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Chervoneva', 'Affiliation': 'Department of Biostatistics, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Intenzo', 'Affiliation': 'Division of Nuclear Medicine, Department of Radiology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Newberg', 'Affiliation': 'Department of Integrative Medicine and Nutritional Sciences, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1548']
1000,32410424,[Evaluation of multimodal analgesia in treatment of avascular necrosis of femoral head with free vascularized fibular grafting].,"Objective


To prospective study the effectiveness and safety of multimodal analgesia (MA) in treatment of avascular necrosis of the femoral head with free vascularized fibular grafting (FVFG).
Methods


Sixty patients with avascular necrosis of the femoral head, who were scheduled to unilateral primary FVFG between February 2016 and December 2016 and met the selection criteria, were included in the study. All patients were allocated to two groups according to the method of random number table: MA group (  n =30) and control group (  n =30). There was no significant difference in gender, age, body mass index, side, duration and stage of avascular necrosis of the femoral head, preoperative visual analogue scale (VAS) scores under quiescent and active states, and range of motion (ROM) of hip flexion and abduction before operation (  P >0.05). The patients in the MA group were treated with MA therapy, including oral administration of celecoxib before operation, local anesthetic wound infiltration during operation, and ice compression and oral administration of celecoxib after operation. The patients in control group were only treated with patient-controlled intravenous analgesia pump. The postoperative VAS scores under quiescent and active states, ROM of hip flexion and abduction, prescription of Tramadol and adverse reaction were recorded and compared.
Results


The operations were completed successfully in both groups without obvious complications and adverse reaction. The Tramadol was used in 4 cases (13.3%) of MA group and in 11 cases (36.7%) of control group, but no significant difference was found between the two groups (  χ   2 =4.356,  P =0.072). The VAS scores under quiescent state at 6 and 24 hours postoperatively were significantly lower in MA group than in control group (  P <0.05), while VAS scores under active state at 48 hours postoperatively and on the day of discharge were significantly lower in MA group than in control group (  P <0.05). There was no significant difference in VAS score between two groups at other time points (  P >0.05). The ROM of hip flexion in MA group was better than that in control group at 1 day postoperatively and the day of discharge (  P <0.05), while no significant difference was found at 2 and 3 days postoperatively (  P >0.05). The ROM of hip abduction in MA group was superior to the control group at 1, 2, and 3 days postoperatively and the day of discharge (  P <0.05).
Conclusion


The MA can effectively relieve the pain following FVFG and facilitate early functional exercises of the hip. The usage of opioids was also relatively fewer for MA protocol.",2020,"The ROM of hip abduction in MA group was superior to the control group at 1, 2, and 3 days postoperatively and the day of discharge (  P <0.05).
","['avascular necrosis of femoral head with free vascularized fibular grafting', 'Sixty patients with avascular necrosis of the femoral head, who were scheduled to unilateral primary FVFG between February 2016 and December 2016 and met the selection criteria, were included in the study', 'avascular necrosis of the femoral head with free vascularized fibular grafting (FVFG']","['patient-controlled intravenous analgesia pump', 'multimodal analgesia (MA', 'Tramadol', 'celecoxib', 'MA therapy', 'multimodal analgesia']","['VAS score', 'postoperative VAS scores under quiescent and active states, ROM of hip flexion and abduction, prescription of Tramadol and adverse reaction', 'gender, age, body mass index, side, duration and stage of avascular necrosis of the femoral head, preoperative visual analogue scale (VAS) scores under quiescent and active states, and range of motion (ROM) of hip flexion and abduction before operation', 'VAS scores under quiescent state', 'ROM of hip abduction', 'VAS scores under active state', 'ROM of hip flexion']","[{'cui': 'C0410480', 'cui_str': 'Avascular necrosis of the head of femur'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0042382', 'cui_str': 'Vascularized'}, {'cui': 'C0016068', 'cui_str': 'Bone structure of fibula'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0410480', 'cui_str': 'Avascular necrosis of the head of femur'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",60.0,0.0218635,"The ROM of hip abduction in MA group was superior to the control group at 1, 2, and 3 days postoperatively and the day of discharge (  P <0.05).
","[{'ForeName': 'Difei', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, P.R.China.""}, {'ForeName': 'Yani', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, P.R.China.""}, {'ForeName': 'Yigang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, P.R.China.""}, {'ForeName': 'Sanlian', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': ""Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, P.R.China.""}]",Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery,['10.7507/1002-1892.201907023']
1001,31208475,Sex differences in postprandial responses to different dairy products on lipoprotein subclasses: a randomised controlled cross-over trial.,"Men have earlier first-time event of CHD and higher postprandial TAG response compared with women. The aim of this exploratory sub-study was to investigate if intake of meals with the same amount of fat from different dairy products affects postprandial lipoprotein subclasses differently in healthy women and men. A total of thirty-three women and fourteen men were recruited to a randomised controlled cross-over study with four dairy meals consisting of butter, cheese, whipped cream or sour cream, corresponding to 45 g of fat (approximately 60 energy percent). Blood samples were taken at 0, 2, 4 and 6 h postprandially. Lipoprotein subclasses were measured using NMR and analysed using a linear mixed model. Sex had a significant impact on the response in M-VLDL (P=0·04), S-LDL (P=0·05), XL-HDL (P=0·009) and L-HDL (P=0·001) particle concentration (P), with women having an overall smaller increase in M-VLDL-P, a larger decrease in S-LDL-P and a larger increase in XL- and L-HDL-P compared with men, independent of meal. Men showed a decrease in XS-VLDL-P compared with women after intake of sour cream (P<0·01). In men only, XS-VLDL-P decreased after intake of sour cream compared with all other meals (v. butter: P=0·001; v. cheese: P=0·04; v. whipped cream: P=0·006). Meals with the same amount of fat from different dairy products induce different postprandial effects on lipoprotein subclass concentrations in men and women.",2019,Men showed a decrease in XS-VLDL-P compared to women after intake of sour cream (P&lt;0.01).,"['healthy women and men', 'men and women', 'Thirty-three women and 14 men']","['Dairy Products', 'dairy meals consisting of butter, cheese, whipped cream or sour cream']","['lipoprotein subclass concentrations', 'Sex Differences', 'postprandial triglyceride response', 'Lipoprotein subclasses', 'XL-HDL', 'L-HDL', 'XL-, and L-HDL-P', 'postprandial lipoprotein subclasses', 'M-VLDL-P', 'XS-VLDL-P', 'response in M-VLDL', 'S-LDL']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}]","[{'cui': 'C0010947', 'cui_str': 'Dairy Products'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0006494', 'cui_str': 'Butter'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0452750', 'cui_str': 'Whipping cream (substance)'}, {'cui': 'C0452749', 'cui_str': 'Soured cream (substance)'}]","[{'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0445604', 'cui_str': 'Subclass (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036866', 'cui_str': 'Sexual Dimorphism'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0523560', 'cui_str': 'VLDL cholesterol measurement'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]",,0.0856183,Men showed a decrease in XS-VLDL-P compared to women after intake of sour cream (P&lt;0.01).,"[{'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Hansson', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, P.O. Box 1046, Blindern, 0317 Oslo, Norway.'}, {'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Holven', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, P.O. Box 1046, Blindern, 0317 Oslo, Norway.'}, {'ForeName': 'Linn K L', 'Initials': 'LKL', 'LastName': 'Øyri', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, P.O. Box 1046, Blindern, 0317 Oslo, Norway.'}, {'ForeName': 'Hilde K', 'Initials': 'HK', 'LastName': 'Brekke', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, P.O. Box 1046, Blindern, 0317 Oslo, Norway.'}, {'ForeName': 'Gyrd O', 'Initials': 'GO', 'LastName': 'Gjevestad', 'Affiliation': 'TINE SA, Centre for Research and Development, P.O. Box 7, Kalbakken, 0902 Oslo, Norway.'}, {'ForeName': 'Magne', 'Initials': 'M', 'LastName': 'Thoresen', 'Affiliation': 'Oslo Center for Biostatistics and Epidemiology, Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, P.O. Box 1122, Blindern, 0317 Oslo, Norway.'}, {'ForeName': 'Stine M', 'Initials': 'SM', 'LastName': 'Ulven', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, P.O. Box 1046, Blindern, 0317 Oslo, Norway.'}]",The British journal of nutrition,['10.1017/S0007114519001429']
1002,31867673,"Delivery of home-based post-partum contraception in rural Guatemalan women: feasibility, recruitment and retention in a cluster-randomized trial.","BACKGROUND


Few cluster-randomized trials have been performed in rural Guatemala. Our objective was to describe the feasibility, recruitment and retention in our cluster-randomized trial.
METHODS


In our cluster-randomized trial, a range of contraceptives were brought to mothers' homes in rural Guatemala.
RESULTS


Of 173 women approached, 33 were excluded. Of the 140 eligible women, 127 (91%) consented to participate. Of the 87 women who should have been assessed for the primary outcome, three were lost to follow-up, which represents a retention rate of 97%.
CONCLUSIONS


Nurses who are both clinical providers and study staff can feasibly conduct research, which leads to high enrollment and retention rates.",2019,"In our cluster-randomized trial, a range of contraceptives were brought to mothers' homes in rural Guatemala.
","['rural Guatemalan women', ""mothers' homes in rural Guatemala"", '87 women who should have been assessed for the primary outcome', 'Of 173 women approached, 33 were excluded', '140 eligible women, 127 (91%) consented to participate']",['home-based post-partum contraception'],['retention rate'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}]",173.0,0.401071,"In our cluster-randomized trial, a range of contraceptives were brought to mothers' homes in rural Guatemala.
","[{'ForeName': 'Margo S', 'Initials': 'MS', 'LastName': 'Harrison', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Room 4211, Aurora, CO 80045, USA.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Bunge-Montes', 'Affiliation': 'Fundación para la Salud Integral de los Guatemaltecos, Quetzaltenango, Guatemala (FSIG), Calzada Roosevelt 6-25 zona 11 P.O.B 1188, Guatemala City.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Rivera', 'Affiliation': 'Fundación para la Salud Integral de los Guatemaltecos, Quetzaltenango, Guatemala (FSIG), Calzada Roosevelt 6-25 zona 11 P.O.B 1188, Guatemala City.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Jimenez-Zambrano', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Room 4211, Aurora, CO 80045, USA.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Heinrichs', 'Affiliation': 'Denver Health, 777 Bannock St, Denver, CO 80204, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Scarbro', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Room 4211, Aurora, CO 80045, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Juarez-Colunga', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Room 4211, Aurora, CO 80045, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bolanos', 'Affiliation': 'Fundación para la Salud Integral de los Guatemaltecos, Quetzaltenango, Guatemala (FSIG), Calzada Roosevelt 6-25 zona 11 P.O.B 1188, Guatemala City.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Asturias', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Room 4211, Aurora, CO 80045, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Berman', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Room 4211, Aurora, CO 80045, USA.'}, {'ForeName': 'Jeanelle', 'Initials': 'J', 'LastName': 'Sheeder', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Room 4211, Aurora, CO 80045, USA.'}]",International health,['10.1093/inthealth/ihz098']
1003,31195354,High prevalence of severe hypovitaminosis D in patients with advanced gastric cancer treated with first-line chemotherapy with or without anti-EGFR-directed monoclonal antibody (EXPAND trial) showing no prognostic impact.,"PURPOSE


The goal of our analysis was to study pretherapeutic circulating 25-OHD plasma levels in patients with previously untreated advanced gastric cancer treated in the randomised controlled phase III Erbitux (cetuximab) in combination with Xeloda (capecitabine) and cisplatin in advanced esophago-gastric cancer (EXPAND) trial (NCT00678535) and to explore whether low 25-OHD plasma levels are associated with worse prognosis and may compromise the clinical efficacy of cetuximab.
METHODS


Six hundred thirty patients with available pretherapeutic 25-OHD plasma levels and treated with chemotherapy based on capecitabine and cisplatin, or chemotherapy and cetuximab, were included. The Cox proportional hazard regression model was used to analyse the association between low 25-OHD and survival in both treatment arms.
RESULTS


Majority of study patients were found to have severe vitamin D deficiency. No prognostic impact of 25-OHD plasma levels could be found in our patient cohort, and there was no indication of an interference of 25-OHD plasma levels and the efficacy of treatment with the anti-epidermal growth factor receptor monoclonal antibody cetuximab.
CONCLUSIONS


Although majority of patients with advanced gastric cancer show hypovitaminosis D deficiency, there is no proof for a negative impact on survival or reduced treatment response. A prospective study is needed to investigate the potential benefit of vitamin D supplementation in this patient cohort during first-line chemotherapy.",2019,"No prognostic impact of 25-OHD plasma levels could be found in our patient cohort, and there was no indication of an interference of 25-OHD plasma levels and the efficacy of treatment with the anti-epidermal growth factor receptor monoclonal antibody cetuximab.
","['patients with advanced gastric cancer', 'patients with advanced gastric cancer treated with', 'patients with previously untreated advanced gastric cancer', 'Six hundred thirty patients with available pretherapeutic 25-OHD plasma levels and treated with chemotherapy based on', 'patient cohort during first-line chemotherapy']","['capecitabine and cisplatin, or chemotherapy and cetuximab', 'Erbitux (cetuximab) in combination with Xeloda (capecitabine) and cisplatin', 'vitamin D supplementation', 'first-line chemotherapy with or without anti-EGFR-directed monoclonal antibody']","['25-OHD plasma levels', 'severe vitamin D deficiency']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C1173436', 'cui_str': 'Erbitux'}, {'cui': 'C0724419', 'cui_str': 'Xeloda'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}]",630.0,0.0376936,"No prognostic impact of 25-OHD plasma levels could be found in our patient cohort, and there was no indication of an interference of 25-OHD plasma levels and the efficacy of treatment with the anti-epidermal growth factor receptor monoclonal antibody cetuximab.
","[{'ForeName': 'Radka', 'Initials': 'R', 'LastName': 'Obermannova', 'Affiliation': 'Department of Comprehensive Cancer Care, Masaryk Memorial Cancer Institute and Faculty of Medicine, Masaryk University, Brno, Czech Republic; Regional Center of Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Brno, Czech Republic; Department of Pharmacology, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Dalibor', 'Initials': 'D', 'LastName': 'Valik', 'Affiliation': 'Regional Center of Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Brno, Czech Republic; Department of Laboratory Medicine, Masaryk Memorial Cancer Institute, Brno, Czech Republic; Department of Pharmacology, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Hasenclever', 'Affiliation': 'Institute for Medical Informatics, Statistics and Epidemiology, Medical Faculty of University Leipzig, Germany.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Zdrazilova-Dubska', 'Affiliation': 'Regional Center of Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Brno, Czech Republic; Department of Laboratory Medicine, Masaryk Memorial Cancer Institute, Brno, Czech Republic; Department of Pharmacology, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Hacker', 'Affiliation': '1st Medical Department (Hematology, Cell Therapy, Medical Oncology and Hemostaseology), University Cancer Center Leipzig (UCCL), University Leipzig Medical Center, Germany.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Demlova', 'Affiliation': 'Regional Center of Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Brno, Czech Republic; Department of Pharmacology, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Iveta', 'Initials': 'I', 'LastName': 'Selingerova', 'Affiliation': 'Regional Center of Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Brno, Czech Republic; Department of Laboratory Medicine, Masaryk Memorial Cancer Institute, Brno, Czech Republic.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Lordick', 'Affiliation': '1st Medical Department (Hematology, Cell Therapy, Medical Oncology and Hemostaseology), University Cancer Center Leipzig (UCCL), University Leipzig Medical Center, Germany. Electronic address: florian.lordick@medizin.uni-leipzig.de.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.05.011']
1004,31201785,Proteomic Profiling to Identify Blood Biomarkers Predictive of Response to Azithromycin in Children and Adolescents With Cystic Fibrosis.,"BACKGROUND


Azithromycin reduces pulmonary exacerbation (PEx) risk in cystic fibrosis (CF), but not all individuals benefit. The goal of this study was to discover blood protein biomarkers predictive of clinical response to azithromycin treatment in children and adolescents with CF.
METHODS


Novel proteomic technologies were applied to examine 188 serum and plasma protein samples from 40 patients with CF who were randomized to receive azithromycin in the AZ0004 trial. Early changes in blood protein levels from day 0 to day 28 of treatment were examined in relation to changes in FEV 1  percent predicted and weight by days 28 and 168, and to predict PEx risk by day 168.
RESULTS


Early changes in the levels of 15 plasma proteins following 28 days of azithromycin significantly correlated with changes in FEV 1  percent predicted from day 0 to day 28 (Q value < 0.10), but this finding was not sustained to day 168. Early changes in serum calprotectin levels following 28 days of azithromycin were predictive of PEx risk by day 168 of treatment (area under the curve = 0.76; 95% CI, 0.57-0.95). Based on a calprotectin cutoff to maximize test sensitivity (88%) and specificity (68%), 40% of subjects who had a calprotectin reduction less than the cutoff experienced at least one PEx compared with only 8% of subjects with calprotectin reduction greater than the cutoff.
CONCLUSIONS


Early changes in blood protein biomarkers following azithromycin treatment were associated with short-term changes, but not longer term changes, in lung function. Early change in serum calprotectin level was predictive of response to azithromycin in terms of modifying PEx risk.",2019,"Early changes in serum calprotectin levels following 28 days of azithromycin were predictive of PEx risk by day 168 of treatment (area under the curve = 0.76; 95% CI, 0.57-0.95).","['40 patients with CF', 'Children and Adolescents With Cystic Fibrosis', 'cystic fibrosis (CF', 'children and adolescents with CF']","['Azithromycin', 'azithromycin']","['levels of 15 plasma proteins', 'PEx risk', 'serum calprotectin levels', 'FEV', 'pulmonary exacerbation (PEx) risk', 'blood protein biomarkers', 'serum calprotectin level', 'blood protein levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032120', 'cui_str': 'Plasma Proteins'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0950624', 'cui_str': 'Calgranulin'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0005832', 'cui_str': 'Blood Proteins'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",40.0,0.0297186,"Early changes in serum calprotectin levels following 28 days of azithromycin were predictive of PEx risk by day 168 of treatment (area under the curve = 0.76; 95% CI, 0.57-0.95).","[{'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Dong', 'Affiliation': 'Centre for Heart Lung Innovation, Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Amrit', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'PROOF Centre of Excellence, Vancouver, BC, Canada.'}, {'ForeName': 'Raymond T', 'Initials': 'RT', 'LastName': 'Ng', 'Affiliation': 'PROOF Centre of Excellence, Vancouver, BC, Canada.'}, {'ForeName': 'Don D', 'Initials': 'DD', 'LastName': 'Sin', 'Affiliation': 'Centre for Heart Lung Innovation, Department of Medicine, University of British Columbia, Vancouver, BC, Canada; Division of Respiratory Medicine, Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Tebbutt', 'Affiliation': 'Centre for Heart Lung Innovation, Department of Medicine, University of British Columbia, Vancouver, BC, Canada; Division of Respiratory Medicine, Department of Medicine, University of British Columbia, Vancouver, BC, Canada; PROOF Centre of Excellence, Vancouver, BC, Canada.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Ratjen', 'Affiliation': 'Division of Respiratory Medicine, Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Quon', 'Affiliation': 'Centre for Heart Lung Innovation, Department of Medicine, University of British Columbia, Vancouver, BC, Canada; Division of Respiratory Medicine, Department of Medicine, University of British Columbia, Vancouver, BC, Canada. Electronic address: bradley.quon@hli.ubc.ca.'}]",Chest,['10.1016/j.chest.2019.05.017']
1005,31129386,"FOLFOX alone or combined with rilotumumab or panitumumab as first-line treatment for patients with advanced gastroesophageal adenocarcinoma (PRODIGE 17-ACCORD 20-MEGA): a randomised, open-label, three-arm phase II trial.","BACKGROUND


Epidermal growth factor receptor (EGFR) and hepatocyte growth factor (HGF)/mesenchymal-epithelial transition (MET) pathways, which promote tumour growth and proliferation, are often deregulated in advanced gastroesophageal adenocarcinomas. We assessed whether adding panitumumab (an EGFR inhibitor) or rilotumumab (a HGF inhibitor) to first-line fluoropyrimidine-based and platinum-based chemotherapy (modified oxaliplatin, leucovorin and fluorouracil [mFOLFOX6]) benefits to patients with advanced gastroesophageal adenocarcinoma.
PATIENTS AND METHODS


This phase II, open-label, randomised, three-arm study enrolled patients ≥18 years, with advanced gastroesophageal adenocarcinoma, Eastern Cooperative Oncology Group performance status 0-1 and no known HER2 overexpression. Patients were randomly assigned (1:1:1) mFOLFOX6 (oxaliplatin 85 mg/m 2 , leucovorin 400 mg/m 2 , 5-fluorouracil 400 mg/m 2  bolus then 2400 mg/m 2  over 46 h) alone or combined with panitumumab (6 mg/kg) or rilotumumab (10 mg/kg) every 2 weeks until limiting toxicity, patient's refusal or disease progression. The primary end-point was the 4-month progression-free survival (PFS) rate. Secondary end-points included overall survival (OS) and tolerance.
RESULTS


The study enrolled 162 patients in 29 French centres. The median follow-up was 23.6 months (interquartile range = 16.4-29.0). The 4-month PFS rate was 71% (95% confidence interval [CI] = 57-82) with chemotherapy alone, 57% (95% CI = 42-71) combined with panitumumab and 61% (95% CI = 47-74) combined with rilotumumab. Median OS was 13.1 months (95% CI = 8.7-16.9) with chemotherapy alone, 8.3 months (95% CI = 6.2-13.2) combined with panitumumab and 11.5 months (95% CI = 7.9-17.1) combined with rilotumumab. Adverse events grade ≥III occurred less frequently with chemotherapy alone (62%) than with panitumumab (83%) and rilotumumab (89%).
CONCLUSIONS


We found no benefit in adding panitumumab or rilotumumab to mFOLFOX6 first-line chemotherapy to treat advanced gastroesophageal adenocarcinoma patients.
TRIAL REGISTRATION


European Clinical Trials Database, number 2009-012797-12.",2019,"Median OS was 13.1 months (95% CI = 8.7-16.9) with chemotherapy alone, 8.3 months (95% CI = 6.2-13.2) combined with panitumumab and 11.5 months (95% CI = 7.9-17.1) combined with rilotumumab.","['162 patients in 29 French centres', 'patients with advanced gastroesophageal adenocarcinoma (PRODIGE 17-ACCORD 20-MEGA', 'patients with advanced gastroesophageal adenocarcinoma', 'advanced gastroesophageal adenocarcinoma patients', 'enrolled patients ≥18 years, with advanced gastroesophageal adenocarcinoma, Eastern Cooperative Oncology Group performance status 0-1 and no known HER2 overexpression']","['FOLFOX alone or combined with rilotumumab or panitumumab', 'panitumumab', 'mFOLFOX6 (oxaliplatin 85\xa0mg/m 2 , leucovorin 400\xa0mg/m 2 , 5-fluorouracil 400', 'mg/m 2  over 46\xa0h) alone or combined with panitumumab', 'panitumumab (an EGFR inhibitor) or rilotumumab (a HGF inhibitor) to first-line fluoropyrimidine-based and platinum-based chemotherapy (modified oxaliplatin, leucovorin and fluorouracil [mFOLFOX6', 'rilotumumab']","['4-month PFS rate', 'Median OS', '4-month progression-free survival (PFS) rate', 'Adverse events grade ≥III', 'overall survival (OS) and tolerance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2743963', 'cui_str': 'rilotumumab'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}]",162.0,0.235601,"Median OS was 13.1 months (95% CI = 8.7-16.9) with chemotherapy alone, 8.3 months (95% CI = 6.2-13.2) combined with panitumumab and 11.5 months (95% CI = 7.9-17.1) combined with rilotumumab.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Malka', 'Affiliation': 'Department of Cancer Medicine, Gustave Roussy, Université Paris-Saclay, Villejuif, France. Electronic address: david.malka@gustaveroussy.fr.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'François', 'Affiliation': 'Department of Medical Oncology, Centre Antoine Lacassagne, Nice, France.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Penault-Llorca', 'Affiliation': 'Pathology Unit, Centre Jean Perrin, UMR 1240 INSERM IMoST, Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Castan', 'Affiliation': ""Biometrics Unit, Institut du Cancer de Montpellier-Val d'Aurelle, Université de Montpellier, Montpellier, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bouché', 'Affiliation': 'Department of Hepatogastroenterology and Digestive Oncology, Hôpital Robert Debré, Reims, France.'}, {'ForeName': 'Jaafar', 'Initials': 'J', 'LastName': 'Bennouna', 'Affiliation': ""Department of Medical Oncology, Institut de Cancérologie de l'Ouest René Gauducheau, Saint-Herblain, France.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Ghiringhelli', 'Affiliation': 'Department of Medical Oncology, Centre Georges Francois Leclerc, Dijon, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'de la Fouchardière', 'Affiliation': 'Department of Medical Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'Cancer Immunotherapy, INSERM U1098 EFS/BFC, Besançon, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Samalin', 'Affiliation': ""Digestive Oncology Unit, Institut du Cancer de Montpellier-Val d'Aurelle, Montpellier, Université de Montpellier, France.""}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Bachet', 'Affiliation': 'Sorbonne Université, Hôpitaux Universitaires Pitié-Salpétrière, Department of Hepatogastroenterology, APHP, Paris, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Raoul', 'Affiliation': 'Department of Medical Oncology, Institut Paoli Calmettes, Marseille, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Miglianico', 'Affiliation': 'Department of Radiotherapy, Centre Hospitalier Privé Saint Grégoire, Saint Grégoire, France.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Bengrine-Lefèvre', 'Affiliation': 'Department of Medical Oncology, Hôpital Saint Antoine, Paris, France.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Dahan', 'Affiliation': 'Department of Digestive Oncology, Centre Hospitalier La Timone, Marseille, France.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Lecaille', 'Affiliation': 'Department of Hepatogastroenterology, Polyclinique Bordeaux Nord Aquitaine, Bordeaux, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Aparicio', 'Affiliation': 'Department of Gastroenterology and Digestive Cancerology, Hôpital Avicenne, HUPSSD, Bobigny, Paris 13 University, Sorbonne, Paris Cité, France.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Stanbury', 'Affiliation': 'R&D Unicancer, Paris, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Perrier', 'Affiliation': 'Department of Medical Oncology, Hôpital Saint Joseph, Marseille, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Cayre', 'Affiliation': 'Department of Pathology, LBM OncoGenAuvergne, Clermont Ferrand, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Laurent-Puig', 'Affiliation': 'Université Paris Descartes, Centre de Ressources Biologiques EPIGENETEC, Unité INSERM U775U1147, Paris, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Gourgou', 'Affiliation': ""Biometrics Unit, Institut du Cancer de Montpellier-Val d'Aurelle, Université de Montpellier, Montpellier, France.""}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Emile', 'Affiliation': 'Department of Pathology & EA4340, Hôpital Ambroise Paré & Versailles University, Boulogne Billancourt, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Taïeb', 'Affiliation': 'Department of Hepatogastroenterology and Gastrointestinal Oncology, Hôpital Européen Georges Pompidou, Paris, Sorbonne Paris Cité, Paris Descartes University, France.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.04.020']
1006,28231494,Marijuana and other substance use among male and female underage drinkers who drive after drinking and ride with those who drive after drinking.,"The study sought to describe the occurrence of adolescent driving after drinking (DD) and riding with a driver who had been drinking (RWDD) and associations with substance use for both males and females. As part of screening for a randomized controlled trial, we surveyed 16-20year olds (N=3418) recruited from an emergency department (ED) and analyzed data from those reporting past-year alcohol consumption (n=2150, 58% females). DD was reported by 22% of females and 28% of males and RWDD was reported by 39% of females and 38% of males, also in the past year. In regression models, risky alcohol use and past-year marijuana use were associated with increased odds of DD and RWDD for females and males. Marijuana use was a strong predictor, with odds increased by 2.3 and 1.7 times for DD among females and males respectively and 1.4 times for RWDD for females and males. Prescription drug misuse was also associated with RWDD for females and for both males' and females' reported DD. The findings highlight the alarming rate of DD and RWDD among both males and females and suggest ED-based injury prevention efforts consider such risky road behavior as well as consider their substance use. Future research might also further examine the effects of driving under influence of substances, particularly marijuana, and the negative synergistic effects of co-ingestion prior to driving.",2017,"Marijuana use was a strong predictor, with odds increased by 2.3 and 1.7 times for DD among females and males respectively and 1.4 times for RWDD for females and males.","['male and female underage drinkers who drive after drinking and ride with those who drive after drinking', 'surveyed 16-20year olds (N=3418) recruited from an emergency department (ED) and analyzed data from those reporting past-year alcohol consumption (n=2150, 58% females']",['adolescent driving after drinking (DD) and riding with a driver who had been drinking (RWDD'],"['RWDD', 'rate of DD and RWDD', 'DD']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]",[],3418.0,0.0166934,"Marijuana use was a strong predictor, with odds increased by 2.3 and 1.7 times for DD among females and males respectively and 1.4 times for RWDD for females and males.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Buckley', 'Affiliation': 'University of Michigan Transportation Research Institute, Ann Arbor, MI, United States; University of Michigan Injury Center, Ann Arbor, MI, United States. Electronic address: buckleylisad@gmail.com.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Bonar', 'Affiliation': 'University of Michigan, Department of Psychiatry, Addiction Center, Ann Arbor, MI, United States.'}, {'ForeName': 'Maureen A', 'Initials': 'MA', 'LastName': 'Walton', 'Affiliation': 'University of Michigan Injury Center, Ann Arbor, MI, United States; University of Michigan, Department of Psychiatry, Addiction Center, Ann Arbor, MI, United States.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Carter', 'Affiliation': 'University of Michigan Injury Center, Ann Arbor, MI, United States; University of Michigan, Department of Emergency Medicine, Ann Arbor, MI, United States; Michigan Youth Violence Prevention Center, University of Michigan School of Public Health, Ann Arbor, MI, United States.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Voloshyna', 'Affiliation': 'V.N. Karazin Kharkiv National University, Department of Psychiatry, Narcology, Neurology and Medical Psychology, Kharkiv, Ukraine.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Ehrlich', 'Affiliation': ""University of Michigan Injury Center, Ann Arbor, MI, United States; University of Michigan Health System, C.S. Mott Children's Hospital, Department of Surgery, Section of Pediatric Medicine, Ann Arbor, MI, United States.""}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Cunningham', 'Affiliation': 'University of Michigan Injury Center, Ann Arbor, MI, United States; University of Michigan, Department of Emergency Medicine, Ann Arbor, MI, United States; Michigan Youth Violence Prevention Center, University of Michigan School of Public Health, Ann Arbor, MI, United States; Department of Health Behavior Health Education, University of Michigan School of Public Health, Ann Arbor, MI, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2017.02.016']
1007,31706395,A pilot randomised controlled trial of a programme of psychosocial interventions (Resettle) for high risk personality disordered offenders.,"BACKGROUND


Offenders with personality disorder experience significant co-morbid mental health problems and present with an increased risk of offending. The evidence for the effectiveness of interventions for personality disordered offenders in the community is limited. This study was a pilot study to determine the feasibility of a randomised controlled trial (RCT) of an intervention known as Resettle for personality disordered offenders and to explore the possible effects of this intervention.
METHODS


Potential participants were recruited from referrals of male prisoners to Resettle. Those consenting underwent baseline assessments before being randomised to Resettle or treatment as usual. Officially recorded and self-report offending was assessed over two years following release from custody. Of the 110 eligible participants, 72 (65%) participated in the study of whom 38 were randomised to Resettle and 34 to treatment as usual. The two groups had a similar psychiatric and offending profile.
RESULTS


Analysis of officially recorded offences at two years found mixed results, but whether adopting an intent-to-treat approach or including only those who received the intervention there was no clear evidence of an effect of the intervention. A comparison of self-report offending found no effect of Resettle in an intent-to-treat analysis, but there was an effect when the analysis involved only those participating in the intervention.
CONCLUSIONS


This study demonstrated that with some adjustments it was possible to carry out an RCT of a complex intervention for personality disordered offenders in a criminal justice setting. Some, but not conclusive, evidence was found in favour of the intervention.",2019,"A comparison of self-report offending found no effect of Resettle in an intent-to-treat analysis, but there was an effect when the analysis involved only those participating in the intervention.
","['Potential participants were recruited from referrals of male prisoners to Resettle', 'personality disordered offenders', 'high risk personality disordered offenders', 'Offenders with personality disorder experience significant co-morbid mental health problems', '110 eligible participants, 72 (65%) participated in the study of whom 38 were randomised to Resettle and 34 to treatment as usual', 'personality disordered offenders in a criminal justice setting']","['complex intervention', 'psychosocial interventions (Resettle']",[],"[{'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0031212', 'cui_str': 'Personality Disorders'}, {'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086072', 'cui_str': 'Criminal Justice'}]","[{'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}]",[],110.0,0.139347,"A comparison of self-report offending found no effect of Resettle in an intent-to-treat analysis, but there was an effect when the analysis involved only those participating in the intervention.
","[{'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Nathan', 'Affiliation': 'Institute of Population Health Sciences, University of Liverpool, Block B, Waterhouse Building, 1-5 Dover Street, Liverpool L69 3BX, United Kingdom; Cheshire Wirral Partnerships Research Department, Churton House, Countess of Chester Health Park, Parsons Lane, Chester CH2 1HJ, United Kingdom; Chester Medical School, University of Chester, Bache Hall, Chester CH2 1BR, United Kingdom. Electronic address: taj.nathan@nhs.net.'}, {'ForeName': 'Luna', 'Initials': 'L', 'LastName': 'Centifanti', 'Affiliation': 'Institute of Life and Human Sciences, Department of Clinical Psychology, University of Liverpool, Whelan Building, Quadrangle, Brownlow Hill, Liverpool L69 3GB, United Kingdom.'}, {'ForeName': 'Vikki', 'Initials': 'V', 'LastName': 'Baker', 'Affiliation': 'Mersey Care NHS Trust, Unit 1, 3 de Havilland Drive, International Business Park, Speke, Liverpool L24 8RN, United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'University of Reading, Whiteknights, Po Box 217, Reading, Berkshire RG6 6AH, United Kingdom.'}]",International journal of law and psychiatry,['10.1016/j.ijlp.2019.101463']
1008,31780429,"Effects of massage on vital signs, pain and comfort levels in liver transplant patients.","OBJECTIVES


This study aimed to determine the effects of back massage on postoperative vital signs, pain, and comfort levels in liver transplant patients.
METHODS


A quasi-experimental model with a pretest, a posttest, and a control group was used. The population of the study comprised adult patients who had liver transplantation for the first time. The study sample comprised 84 adult patients who had liver transplantation: 42 experimental (study group) and 42 control group, selected by power analysis and the random sampling method from the population. The data were collected between May and September 2016 using the short-form McGill Pain Questionnaire (SF-MPQ) and the General Comfort Scale. In the study group, the researcher performed back massage twice per day in the morning and evening in the organ transplant service. No treatment was performed in the control group. To analyse the data, descriptive statistics, a chi-squared test, a t-test for dependant groups, and a t-test for independent groups were used.
RESULTS


According to morning and evening follow-ups after liver transplantation, the mean scores of pulse rate, respiration rate, blood pressure values, and pain intensity was lower, and the mean score of sPO 2  (oxygen saturation) levels and comfort levels was higher, with a statistical significance in the experimental group compared with the control group in all measurements before and after back massage (p < 0.001).
CONCLUSIONS


The back massage applied to liver transplant patients positively affected vital signs, decreased the severity of pain, and increased the comfort levels of the patients.",2020,"According to morning and evening follow-ups after liver transplantation, the mean scores of pulse rate, respiration rate, blood pressure values, and pain intensity was lower, and the mean score of sPO 2  (oxygen saturation) levels and comfort levels was higher, with a statistical significance in the experimental group compared with the control group in all measurements before and after back massage (p < 0.001).
","['liver transplant patients', '84 adult patients who had liver transplantation: 42 experimental (study group) and 42 control group, selected by power analysis and the random sampling method from the population', 'adult patients who had liver transplantation for the first time']","['back massage', 'massage']","['mean scores of pulse rate, respiration rate, blood pressure values, and pain intensity', 'McGill Pain Questionnaire (SF-MPQ) and the General Comfort Scale', 'mean score of sPO 2  (oxygen saturation) levels and comfort levels', 'vital signs, pain and comfort levels', 'postoperative vital signs, pain, and comfort levels', 'severity of pain']","[{'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0024985', 'cui_str': 'McGill Pain Questionnaire'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0518766'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",84.0,0.0210863,"According to morning and evening follow-ups after liver transplantation, the mean scores of pulse rate, respiration rate, blood pressure values, and pain intensity was lower, and the mean score of sPO 2  (oxygen saturation) levels and comfort levels was higher, with a statistical significance in the experimental group compared with the control group in all measurements before and after back massage (p < 0.001).
","[{'ForeName': 'Bilsev', 'Initials': 'B', 'LastName': 'Demir', 'Affiliation': 'Vocational School of Health Sciences, Selçuk University, Konya, Turkey.'}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Saritas', 'Affiliation': 'Department of Surgical Nursing, Faculty of Nursing, Inonu University, Malatya, Turkey. Electronic address: serdar.saritas@inonu.edu.tr.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2019.10.004']
1009,31780640,Imaginal retraining decreases craving for high-calorie food in overweight and obese women: A randomized controlled trial.,"Overweight and obesity are epidemic conditions. Obesity is associated with somatic and psychological sequelae, including serious life-shortening disorders (e.g., diabetes). This study aimed to evaluate the efficacy of a newly developed imaginal variant of approach bias modification (i.e., imaginal retraining) for the reduction of craving for high-calorie food. In a randomized controlled trial, 384 women with a body mass index above 25 were allocated to a wait-list control group or to two variants of imaginal retraining (ratio: 1; 0.5; 0.5). The two intervention groups were sent a manual on imaginal retraining. One group was explicitly encouraged and instructed to use electronic reminders (R ER ); the standard retraining group (R S ) was not encouraged to use electronic reminders. Assessments were 6 weeks apart and were carried out online. Craving for high-calorie food represented the primary outcome (based on the Visual Analog Scale, VAS). Secondary outcomes included the Food Cravings Questionnaire (FCQ-T-R). The study was registered as DRKS00017220. Women in the R ER  group utilized the retraining technique more often than those in the R S  condition, and utilization frequency in turn was associated with improvement on craving and eating behavior scales. Both intention-to-treat and per-protocol analyses showed a favorable effect of the R ER  group, which achieved significance on the primary outcome, as well as on several other outcomes relative to controls at a small to medium effect size. For those participants who measured their weight before and after the assessment using a scale, weight loss in the R ER  group was significantly greater compared to the control group. Both retraining groups (R ER : 39.4%; R S : 31.1%) reduced their subjective amount of eating relative to controls (24.2%). Approximately two-thirds of the sample (68.3%) performed the exercises at least once during the study period. The present results show that, when used regularly, imaginal retraining may reduce craving for high-calorie food in overweight and obese women. Of note, there was also evidence suggestive of weight reduction, although no diet or lifestyle change was recommended in the manual. Because a large subgroup neither read the manual nor performed the exercises, we recommend that future imaginal retraining be conveyed via short video clips.",2019,"Women in the R ER  group utilized the retraining technique more often than those in the R S  condition, and utilization frequency in turn was associated with improvement on craving and eating behavior scales.","['384 women with a body mass index above 25', 'overweight and obese women']","['Imaginal retraining', 'wait-list control group or to two variants of imaginal retraining', 'electronic reminders (R ER ); the standard retraining group (R S ) was not encouraged to use electronic reminders', 'manual on imaginal retraining']","['subjective amount of eating relative', 'craving and eating behavior scales', 'Food Cravings Questionnaire (FCQ-T-R', 'weight loss', 'Visual Analog Scale, VAS']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0222045'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",384.0,0.0639822,"Women in the R ER  group utilized the retraining technique more often than those in the R S  condition, and utilization frequency in turn was associated with improvement on craving and eating behavior scales.","[{'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. moritz@uke.uni-hamburg.de.'}, {'ForeName': 'Anja S', 'Initials': 'AS', 'LastName': 'Göritz', 'Affiliation': 'Department of Occupational and Consumer Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Schmotz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Weierstall-Pust', 'Affiliation': 'MSH Medical School Hamburg, University of Applied Sciences and Medical University, Hamburg, Germany.'}, {'ForeName': 'Josefine', 'Initials': 'J', 'LastName': 'Gehlenborg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Gallinat', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Kühn', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Translational psychiatry,['10.1038/s41398-019-0655-7']
1010,31782377,Reproductive state and choline intake influence enrichment of plasma lysophosphatidylcholine-DHA: a  post hoc  analysis of a controlled feeding trial.,"The major facilitator superfamily domain 2a protein was identified recently as a lysophosphatidylcholine (LPC) symporter with high affinity for LPC species enriched with DHA (LPC-DHA). To test the hypothesis that reproductive state and choline intake influence plasma LPC-DHA, we performed a post hoc analysis of samples available through 10 weeks of a previously conducted feeding study, which provided two doses of choline (480 and 930 mg/d) to non-pregnant (n 21), third-trimester pregnant (n 26), and lactating (n 24) women; all participants consumed 200 mg of supplemental DHA and 22 % of their daily choline intake as 2H-labelled choline. The effects of reproductive state and choline intake on total LPC-DHA (expressed as a percentage of LPC) and plasma enrichments of labelled LPC and LPC-DHA were assessed using mixed and generalised linear models. Reproductive state interacted with time (P = 0·001) to influence total LPC-DHA, which significantly increased by week 10 in non-pregnant women, but not in pregnant or lactating women. Contrary to total LPC-DHA, patterns of labelled LPC-DHA enrichments were discordant between pregnant and lactating women (P < 0·05), suggestive of unique, reproductive state-specific mechanisms that result in reduced production and/or enhanced clearance of LPC-DHA during pregnancy and lactation. Regardless of the reproductive state, women consuming 930 v. 480 mg choline per d exhibited no change in total LPC-DHA but higher d3-LPC-DHA (P = 0·02), indicating that higher choline intakes favour the production of LPC-DHA from the phosphatidylethanolamine N-methyltransferase pathway of phosphatidylcholine biosynthesis. Our results warrant further investigation into the effect of reproductive state and dietary choline on LPC-DHA dynamics and its contribution to DHA status.",2019,"Reproductive state interacted with time (P = 0·001) to influence total LPC-DHA, which significantly increased by week 10 in non-pregnant women, but not in pregnant or lactating women.",[],"['reproductive state and choline intake', 'choline', 'supplemental DHA and 22\xa0% of their daily choline intake as 2H-labelled choline']","['total LPC-DHA (expressed as a percentage of LPC) and plasma enrichments of labelled LPC and LPC-DHA', 'total LPC-DHA']",[],"[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0008405', 'cui_str': 'Choline'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",,0.065026,"Reproductive state interacted with time (P = 0·001) to influence total LPC-DHA, which significantly increased by week 10 in non-pregnant women, but not in pregnant or lactating women.","[{'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Klatt', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY 14853, USA.'}, {'ForeName': 'Melissa Q', 'Initials': 'MQ', 'LastName': 'McDougall', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY 14853, USA.'}, {'ForeName': 'Olga V', 'Initials': 'OV', 'LastName': 'Malysheva', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY 14853, USA.'}, {'ForeName': 'J Thomas', 'Initials': 'JT', 'LastName': 'Brenna', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY 14853, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Roberson', 'Affiliation': 'Department of Biomedical Sciences, College of Veterinary Medicine, Cornell University, Ithaca, NY 14853, USA.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Caudill', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY 14853, USA.'}]",The British journal of nutrition,['10.1017/S0007114519002009']
1011,32410425,[Effect of different use time of intermittent pneumatic compression on the incidence of deep vein thrombosis of lower extremities after arthroplasty].,"Objective


To investigate the effect of different use time of intermittent pneumatic compression (IPC) on the incidence of deep vein thrombosis (DVT) of lower extremities after arthroplasty.
Methods


Between October 2018 and February 2019, 94 patients who planned to undergo unilateral total hip or knee arthroplsty and met the selection criteria were randomly divided into a control group (47 cases) and a trial group (47 cases). There was no significant difference in gender, age, surgical site, and surgical reason between the two groups (  P >0.05). After returning to the ward, all patients were treated with IPC. And the IPC was used until 9:00 pm on the day after operation in the trial group and until 8:00 am the next day after operation in the control group. The levels of hemoglobin, platelet count, D-dimer, hospital stay, treatment costs, patients' satisfaction with IPC, the parameters of thromboelastrography [kinetics (K value), freezing angle (α angle), reaction time (R value), maximum amplitude (MA value)], visual analogue scale (VAS) score, circumference difference of calf before and after operation, Pittsburgh sleep assessment score, and the incidence of DVT of lower limbs were recorded and compared between the two groups.
Results


The K value and D-dimer before operation were significant different between the two groups (  P <0.05). There was no significant difference in pre- and post-operative hemoglobin, platelet count, and the other parameters of thromboelastography between the two groups (  P >0.05). There was no significant difference in pre- and post-operative VAS scores and post-operative circumference difference of calf between the two groups (  P >0.05). The sleep assessment score of the trial group at 1 day after operation was significant lower than that of the control group (  t =2.107,  P =0.038). There was no significant difference in the hospital stay and treatment costs between the two groups (  P >0.05). There was 1 case (2.1%) of DVT, 3 cases (6.4%) of intermuscular venous thrombosis, and 1 case (2.1%) of infection in the trial group, and 2 cases (4.3%), 4 cases (8.5%), and 0 (0) in the control group. The differences were not significant (  P >0.05). After the completion of postoperative IPC treatment, the satisfaction rates of using IPC were 89.4%(42/47) in the trial group and 70.2% (33/47) in the control group, and the difference was not significant (  χ   2 =0.097,  P =0.104).
Conclusion


IPC using for a short period of time after arthroplasty do not increase the degrees of the pain and the swelling of calf; it can effectively prevent DVT of the lower extremity, improve the quality of sleep in patients, and is good for the limbs rehabilitation.",2020,There was no significant difference in the hospital stay and treatment costs between the two groups (  P >0.05).,"['deep vein thrombosis (DVT) of lower extremities after arthroplasty', 'deep vein thrombosis of lower extremities after arthroplasty', 'Methods\n\n\nBetween October 2018 and February 2019, 94 patients who planned to undergo unilateral total hip or knee arthroplsty and met the selection criteria']","['intermittent pneumatic compression (IPC', 'intermittent pneumatic compression', 'IPC']","['pre- and post-operative VAS scores and post-operative circumference difference of calf', 'quality of sleep', 'gender, age, surgical site, and surgical reason', 'satisfaction rates of using IPC', 'hospital stay and treatment costs', 'K value and D-dimer before operation', 'sleep assessment score', ""levels of hemoglobin, platelet count, D-dimer, hospital stay, treatment costs, patients' satisfaction with IPC, the parameters of thromboelastrography [kinetics (K value), freezing angle (α angle), reaction time (R value), maximum amplitude (MA value)], visual analogue scale (VAS) score, circumference difference of calf before and after operation, Pittsburgh sleep assessment score, and the incidence of DVT of lower limbs"", 'pre- and post-operative hemoglobin, platelet count, and the other parameters of thromboelastography', 'intermuscular venous thrombosis']","[{'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0340708', 'cui_str': 'Deep venous thrombosis of lower extremity'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}]",,0.0215101,There was no significant difference in the hospital stay and treatment costs between the two groups (  P >0.05).,"[{'ForeName': 'Liqun', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, P.R.China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Duan', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, P.R.China.'}, {'ForeName': 'Dengbin', 'Initials': 'D', 'LastName': 'Liao', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, P.R.China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Luo', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, P.R.China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Hou', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, P.R.China.'}]",Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery,['10.7507/1002-1892.201907095']
1012,31779056,Evaluation of Waning Immunity at 6 Months after Both Trivalent and Quadrivalent Influenza Vaccination in Korean Children Aged 6-35 Months.,"BACKGROUND


The titer of influenza vaccine-induced antibodies declines over time, and younger children have lower immunogenicity and shorter duration of immunity. This study aimed to compare persistence of antibody at 6 months after influenza vaccination according to influenza virus strains, vaccine type, antigen dose, and primed status in children aged 6 to 35 months.
METHODS


A total 124 healthy children aged 6 to 35 months were enrolled from September to December 2016 at 10 hospitals in Korea and randomly assigned to either a full dose of quadrivalent influenza vaccine or a half dose of trivalent influenza vaccine with Victoria B strain group. Hemagglutination inhibition antibody titers (that measure the seroprotection rates) were assessed for the recommended influenza strains at 6 months post vaccination.
RESULTS


The seroprotection rates at 6 months for strains A (H1N1), A (H3N2), B/Yamagata, and B/Victoria were 88.7%, 97.4%, 36.6%, and 27.6%, respectively. The seroprotection rates for A (H1N1), A (H3N2) and B (Victoria) were 91.4%, 98.7% and 27.5% in a full dose of quadrivalent vaccine vs. 83.7%, 94.6% and 27.9% in a half dose trivalent vaccine, respectively. The seroprotection rate for the B (Yamagata) strain was 23.8% in the quadrivalent group and 14.0% in the trivalent group.
CONCLUSION


Persistence of antibodies at 6 months was more favorable against the influenza A strains than against the B strains. Persistence of antibodies to additional B strain at 6 months was superior in the quadrivalent vaccine group. The immunity of primed children with different B strains was not superior to that of the unprimed group with another B strain.",2019,The immunity of primed children with different B strains was not superior to that of the unprimed group with another B strain.,"['Korean Children Aged 6-35 Months', 'A total 124 healthy children aged 6 to 35 months were enrolled from September to December 2016 at 10 hospitals in Korea', 'children aged 6 to 35 months']","['Trivalent and Quadrivalent Influenza Vaccination', 'quadrivalent influenza vaccine or a half dose of trivalent influenza vaccine with Victoria B strain group']","['seroprotection rate for the B (Yamagata) strain', 'seroprotection rates for A (H1N1), A (H3N2) and B (Victoria', 'seroprotection rates', 'Hemagglutination inhibition antibody titers']","[{'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0591126', 'cui_str': 'AT 10'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}, {'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0770694'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}]",124.0,0.0470298,The immunity of primed children with different B strains was not superior to that of the unprimed group with another B strain.,"[{'ForeName': 'Jee Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Pediatrics, Korea University Ansan Hospital, Ansan, Korea.'}, {'ForeName': 'Hye Kyung', 'Initials': 'HK', 'LastName': 'Cho', 'Affiliation': 'Department of Pediatrics, Gachon University College of Medicine, Incheon, Korea.'}, {'ForeName': 'Ki Hwan', 'Initials': 'KH', 'LastName': 'Kim', 'Affiliation': ""Department of Pediatrics, Incheon St. Mary's Hospital, The Catholic University of Korea, Incheon, Korea.""}, {'ForeName': 'Jina', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Pediatrics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yae Jean', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Pediatrics, School of Medicine, Sungkyunkwan University, Seoul, Korea.'}, {'ForeName': 'Byung Wook', 'Initials': 'BW', 'LastName': 'Eun', 'Affiliation': 'Department of Pediatrics, Nowon Eulji Medical Center, Eulji University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Nam Hee', 'Initials': 'NH', 'LastName': 'Kim', 'Affiliation': 'Department of Pediatrics, Inje University Ilsan Paik Hospital, Goyang, Korea.'}, {'ForeName': 'Dong Ho', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Pediatrics, Korea Institute of Radiological Medical Sciences, Seoul, Korea.'}, {'ForeName': 'Dae Sun', 'Initials': 'DS', 'LastName': 'Jo', 'Affiliation': ""Department of Pediatrics, Chonbuk National University Children's Hospital, Jeonju, Korea.""}, {'ForeName': 'Hwang Min', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'Department of Pediatrics, Yonsei University, Wonju College of Medicine, Wonju, Korea.'}, {'ForeName': 'Yun Kyung', 'Initials': 'YK', 'LastName': 'Kim', 'Affiliation': 'Department of Pediatrics, Korea University Ansan Hospital, Ansan, Korea. byelhana@korea.ac.kr.'}]",Journal of Korean medical science,['10.3346/jkms.2019.34.e279']
1013,31781732,Is the Effect of a High-Intensity Functional Exercise Program on Functional Balance Influenced by Applicability and Motivation among Older People with Dementia in Nursing Homes?,"BACKGROUND AND OBJECTIVES


Exercise can be an important way of maintaining balance function in people with dementia, but further investigation is needed to determine the optimal way of exercising. The objective was to evaluate whether exercise applicability (i.e., attendance, exercise intensity, and adverse events) and motivation were associated with the effect on functional balance of a high-intensity functional exercise program for older people with dementia in nursing homes.
DESIGN, SETTING AND PARTICIPANTS


Exercise intervention participants (n = 81; 60 women, 21 men) from a randomized controlled trial (UMDEX) were included. Their mean age was 84 and mean Mini-Mental State Examination score was 15.
INTERVENTION


Groups of 3-8 participants participated in the High-Intensity Functional Exercise (HIFE) Program, with 5 sessions per 2-week period, for 4 months (total, 40 sessions).
MEASUREMENTS


Outcome was the Berg Balance Scale (BBS), assessed at baseline and follow up, and the score difference, dichotomized to classify participants into two groups: responders (≥5-point increase) and non-responders (<5-point increase). Target variables were measures of applicability and motivation. Associations between each target variable and the outcome were analyzed using multivariable logistic regression. Baseline characteristics and new medical conditions developing during the intervention period were compared between responders and non-responders and included in the analyses when p < 0.10.
RESULTS


The BBS score was 28.6 ± 14.3 at baseline and 31.2 ± 15.3 at follow up, with the difference between follow-up and baseline scores ranging from -35 to 24. Twenty-nine (35.8%) participants were responders. The multivariable models showed no significant association between responders vs. non-responders and any target variable.
CONCLUSION


Participation in a 4-month high-intensity functional exercise program can improve balance in many individuals with dementia in nursing homes, despite the progressiveness of dementia disorders and several co-existing medical conditions. Predicting balance exercise response based on applicability and motivation seem not to be possible, which lends no support for excluding this group from functional exercise, even when exercise intensity or motivation is not high.",2019,"The BBS score was 28.6 ± 14.3 at baseline and 31.2 ± 15.3 at follow up, with the difference between follow-up and baseline scores ranging from -35 to 24.","['older people with dementia in nursing homes', 'people with dementia', 'Exercise intervention participants (n = 81; 60 women, 21 men', 'Older People with Dementia in Nursing Homes']","['High-Intensity Functional Exercise (HIFE', 'High-Intensity Functional Exercise Program', 'high-intensity functional exercise program', 'intensity functional exercise program']","['Berg Balance Scale (BBS', 'BBS score', 'mean Mini-Mental State Examination score', 'exercise applicability (i.e., attendance, exercise intensity, and adverse events) and motivation']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",60.0,0.0709431,"The BBS score was 28.6 ± 14.3 at baseline and 31.2 ± 15.3 at follow up, with the difference between follow-up and baseline scores ranging from -35 to 24.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sondell', 'Affiliation': 'Anna Sondell, Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, SE-90187 Umeå, Sweden, Phone: +46907865289, Fax: +469058093, Email: anna.sondell@umu.se.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Littbrand', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Holmberg', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Lindelöf', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rosendahl', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-019-1269-8']
1014,31770139,"Efficacy and Safety of Vonoprazan in Patients With Nonerosive Gastroesophageal Reflux Disease: A Randomized, Placebo-Controlled, Phase 3 Study.","OBJECTIVES


To assess the efficacy and safety of vonoprazan on heartburn symptoms in patients with nonerosive reflux disease (NERD) (ClinicalTrials.gov: NCT02954848).
METHODS


This phase 3, double-blind, placebo-controlled study included Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn. Patients received placebo (n = 245) or vonoprazan 10 mg (n = 238) for 4 weeks. The primary efficacy outcome was frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn). Other outcomes included cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution in the fourth week of treatment, and safety.
RESULTS


Compared with placebo, the proportion of days without heartburn was not significantly higher in the vonoprazan group in the full analysis (primary end point, 72.55% vs 61.50%, vonoprazan vs placebo, P = 0.0643) but was significantly higher in the per-protocol-set sensitivity analysis (P = 0.0341). Early onset of response and significantly greater cumulative improvement rates of heartburn were observed in the vonoprazan group (P = 0.0003). In a post hoc analysis, a greater proportion of patients with complete heartburn resolution in the fourth week of treatment were reported in the vonoprazan group (P = 0.0023). Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
DISCUSSION


Although vonoprazan 10 mg was not superior to placebo with respect to proportion of days without heartburn in Japanese patients with NERD, vonoprazan had a significantly higher cumulative rate of heartburn resolution and was well tolerated.",2019,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","['Patients With Nonerosive Gastroesophageal Reflux Disease', 'Japanese patients with NERD', 'patients with nonerosive reflux disease (NERD', 'Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn']","['placebo', 'Placebo', 'Vonoprazan', 'vonoprazan']","['cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution', 'safety', 'tolerated', 'cumulative rate of heartburn resolution', 'Incidence of treatment-emergent adverse events', 'efficacy and safety', 'complete heartburn resolution', 'heartburn symptoms', 'cumulative improvement rates of heartburn', 'proportion of days without heartburn', 'Efficacy and Safety', 'frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4080009', 'cui_str': 'Vonoprazan'}]","[{'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.488409,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Izumo, Japan.'}, {'ForeName': 'Yuuichi', 'Initials': 'Y', 'LastName': 'Sakurai', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Takabayashi', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kudou', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Araki', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Miyagi', 'Affiliation': 'Department of Internal Medicine, Fukuyama Daiichi Hospital, Hiroshima, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Iwakiri', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Ashida', 'Affiliation': 'Department of Gastroenterology, Rakuwakai Otowa Hospital, Kyoto, Japan.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000101']
1015,31774376,Influence of Foot-Landing Positions at Initial Contact on Knee Flexion Angles for Single-Leg Drop Landings.,"Purpose : Small knee flexion angles are associated with increased non-contact anterior cruciate ligament (ACL) injury risks. The purpose of this study was to provide insights into how ankle plantar flexion angles influenced knee flexion angles at initial contact during single-leg drop landings.  Method : Thirteen male recreational basketball players performed single-leg drop landings from a 30-cm high platform using three randomized foot-landing positions (natural, fore-foot, and flat-foot). A motion capture system and a force plate were used to measure lower extremity kinematics and vertical ground reaction force (VGRF). A one-way repeated measures Analysis of Variance and the Friedman test were conducted (α = .05).  Results : Foot-landing position had a significant effect on knee flexion angles at initial contact ( p  < .001). As compared to flat-foot landings (18° ( SD  5°), significantly smaller knee flexion angles were found for natural (mean 12° ( SD  5°),  p  = .004) and fore-foot landings (mean 12° ( SD  3°),  p  = .001). There was however significantly smaller knee flexion range of motion in flat-foot landings (mean 42° ( SD  3°), as compared to natural landings (mean 48° ( SD  4°) ( p  < .001). Flat-foot landings also resulted in a 1.4 times higher maximum VGRF than fore-foot landings ( p  < .001) and 1.3 times higher than natural landings ( p  = .005).  Conclusions : Natural and fore-foot landings are better for force absorption but are associated with smaller knee flexion angles at initial contact. These findings have important implications for non-contact ACL injuries.",2020,Natural and fore-foot landings are better for force absorption but are associated with smaller knee flexion angles at initial contact.,"['Single-leg Drop Landings', 'Thirteen male recreational basketball players']",[],"['knee flexion angles', 'extremity kinematics and vertical ground reaction force (VGRF', 'smaller knee flexion range of motion in flat-foot landings', 'fore-foot landings', 'smaller knee flexion angles']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0557668', 'cui_str': 'Landing (environment)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}]",[],"[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0016202', 'cui_str': 'Splayfoot'}, {'cui': 'C0557668', 'cui_str': 'Landing (environment)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}]",13.0,0.0199017,Natural and fore-foot landings are better for force absorption but are associated with smaller knee flexion angles at initial contact.,"[{'ForeName': 'Phillis Soek Po', 'Initials': 'PSP', 'LastName': 'Teng', 'Affiliation': 'Nanyang Technological University.'}, {'ForeName': 'Kah Fai', 'Initials': 'KF', 'LastName': 'Leong', 'Affiliation': 'Nanyang Technological University.'}, {'ForeName': 'Pui Wah', 'Initials': 'PW', 'LastName': 'Kong', 'Affiliation': 'Nanyang Technological University.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2019.1669765']
1016,31774380,Seeing Is Believing: Blind Putting Drills Confer No Advantage to the Novice Golfer.,"Purpose : Golf coaches may recommend ""blind"" putting drills in which golfers close their eyes to improve their feel. Research on specificity of learning suggests, however, that adding or removing a source of sensory information after practicing under differing circumstances can cause performance decrements. Specificity of learning is also dependent upon specific task requirements. The purpose of this study was to examine whether golf putting, requiring body positioning and aiming an implement, would benefit from blind training.  Method : Novice golfers (n = 24) in Vision Training (VT) & No-Vision Training (NVT) groups completed 108 trials of a 10-ft putt. After a 24-hr delay, both groups completed sighted- and blind-putting tests.  Results : Acquisition results revealed Group × Block interactions in RE ( p  = .025) and y-VE ( p  = .032). Post hoc procedures revealed significant differences between the groups on Block 2 ( p  = .017), with the NVT group producing longer mean RE. During testing, RE and x-VE results revealed Group × Test interactions ( p  = .027 & .041), such that performance of the VT group suffered when transferred to blind putting, while performance of the NVT group did not differ when transferred.  Conclusion : NVT did not confer any advantage for subsequent performance with vision. Moreover, results were not consistent with the specificity of learning hypothesis and suggest that putting does not rely on complete sensory integration to support subsequent performance. Presumably, task requirements related to body positioning provided adequate sensory cues for successful performance.",2020,Acquisition results revealed Group × Block interactions in RE ( p  = .025) and y-VE ( p  = .032).,[],"['Vision Training (VT) ', 'NVT', 'No-Vision Training (NVT']",[],[],"[{'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",[],,0.0352187,Acquisition results revealed Group × Block interactions in RE ( p  = .025) and y-VE ( p  = .032).,"[{'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Fisher', 'Affiliation': 'Central Michigan University.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Fairbrother', 'Affiliation': 'University of Tennessee.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2019.1674443']
1017,31774382,Can the Stereotype Threat and Lift Phenomenon Be Applicable to a Muscular Endurance Task?,"Purpose . Inducing a negative stereotype toward women usually leads to a decrease in women performance and an increase in men performance. These effects were observed during technical tasks. The purpose of the present study was to investigate the effect of this sex stereotype during a non-technical muscular endurance task. The perception of effort, closely related to endurance performance, was also recorded. Based on the type of task and the mere effort account, we predicted that both men and women in the negative stereotype toward women condition would perform better than participants in the two other groups.  Method . Seventy-seven participants (38 women and 39 men) were randomly assigned to a negative stereotype toward women, a nullified-stereotype, or a control condition. Then, they performed a submaximal handgrip task until exhaustion at 50% of their maximal strength.  Results . This study showed that performance at T2 was reduced for men and women in the nullified-stereotype and control conditions, but not in the negative stereotype toward women condition, revealing that participants in the negative stereotype toward women condition performed better than participants in the other conditions. No significant difference was observed concerning the perception of effort according to the conditions.  Conclusion . As compared to technical tasks, inducing a negative stereotype toward women increased women's performance. The perception of effort could be responsible for this performance improvement. However, more research is needed to investigate the mechanisms involved. Concerning men, in line with the stereotype lift phenomenon, a performance increase was observed in this same condition.",2020,"This study showed that performance at T2 was reduced for men and women in the nullified-stereotype and control conditions, but not in the negative stereotype toward women condition, revealing that participants in the negative stereotype toward women condition performed better than participants in the other conditions.",['Seventy-seven participants (38 women and 39 men'],"['negative stereotype toward women, a nullified-stereotype, or a control condition', 'sex stereotype during a non-technical muscular endurance task']",['men performance'],"[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}]",77.0,0.0306224,"This study showed that performance at T2 was reduced for men and women in the nullified-stereotype and control conditions, but not in the negative stereotype toward women condition, revealing that participants in the negative stereotype toward women condition performed better than participants in the other conditions.","[{'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Deshayes', 'Affiliation': ""Université Côte d'Azur.""}, {'ForeName': 'Raphaël', 'Initials': 'R', 'LastName': 'Zory', 'Affiliation': ""Université Côte d'Azur.""}, {'ForeName': 'Allison E', 'Initials': 'AE', 'LastName': 'Seitchik', 'Affiliation': 'Merrimack College.'}, {'ForeName': 'Aïna', 'Initials': 'A', 'LastName': 'Chalabaev', 'Affiliation': 'Université Grenoble Alpes.'}, {'ForeName': 'Corentin', 'Initials': 'C', 'LastName': 'Clément-Guillotin', 'Affiliation': ""Université Côte d'Azur.""}]",Research quarterly for exercise and sport,['10.1080/02701367.2019.1668518']
1018,31585702,Which hospitalized smokers receive a prescription for quit-smoking medication at discharge? A secondary analysis of a smoking cessation randomized clinical trial.,"OBJECTIVE


To determine the prevalence and predictors of receiving a smoking cessation medication prescription at discharge.
METHODS


Retrospective analysis of ongoing Human Studies Committee-approved clinical trial data at large tertiary care center, The University of Kansas Medical Center. Patients included were smokers over 18, either Spanish or English speaking, those admitted between October 1, 2016 through May 31, 2018. Other eligibility criteria include access to a telephone or mobile phone, not currently be pregnant or breastfeeding, have no significant co-morbidity that precludes participation (acute, life-threatening illness, and communication barriers such as tracheal tube or altered mental status). Those included in this analysis were those randomized into the trial who expressed interest in receiving a smoking cessation medication prescription at discharge.
RESULTS


Two hundred fourteen patients were recommended a prescription by their smoking cessation counselor, 88 patients (41.12%) were approved a prescription at discharge. Out of those approved, 50.70 (14.05 SD) was the average age, 12.84 (8.47 SD) was the average number of cigarettes used per day, 47 patients (53.41%) were White, 49 patients (55.68%) were admitted through the emergency department, 55 patients (62.50%) had used smoking cessation medication in the past, 49 patients (55.68%) had used inpatient smoking cessation, 36 patients (40.91%) had Medicaid. A binary logistic regression determined to show insurance status (P = 0.042) and use of inpatient smoking cessation medication use (P < 0.001) as statistically significant predictors of receiving a prescription at discharge.
CONCLUSION


It was determined that among the population recommended for medication, 41.12% actually received a prescription at discharge. The variables of ""health insurance status"" and ""use of inpatient smoking cessation medication"" demonstrated to be predictors of receiving a prescription. It is important to further study this as many patients rely on a prescription to afford these medications that are useful in a quit attempt.",2019,"A binary logistic regression determined to show insurance status (P = 0.042) and use of inpatient smoking cessation medication use (P < 0.001) as statistically significant predictors of receiving a prescription at discharge.
","['Two hundred fourteen patients were recommended a prescription by their smoking cessation counselor, 88 patients (41.12%) were approved a prescription at discharge', 'Patients included were smokers over 18, either Spanish or English speaking, those admitted between October 1, 2016 through May 31, 2018', 'Retrospective analysis of ongoing Human Studies Committee-approved clinical trial data at large tertiary care center, The University of Kansas Medical Center', 'Out of those approved, 50.70 (14.05 SD) was the average age, 12.84 (8.47 SD) was the average number of cigarettes used per day, 47 patients (53.41%) were White, 49 patients (55.68%) were admitted through the emergency department, 55 patients (62.50%) had used smoking cessation medication in the past, 49 patients (55.68%) had used inpatient smoking cessation, 36 patients (40.91%) had Medicaid']",[],[],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}]",[],[],214.0,0.0332641,"A binary logistic regression determined to show insurance status (P = 0.042) and use of inpatient smoking cessation medication use (P < 0.001) as statistically significant predictors of receiving a prescription at discharge.
","[{'ForeName': 'Vivek N', 'Initials': 'VN', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'Kimber P', 'Initials': 'KP', 'LastName': 'Richter', 'Affiliation': ''}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Mussulman', 'Affiliation': ''}, {'ForeName': 'Niaman', 'Initials': 'N', 'LastName': 'Nazir', 'Affiliation': ''}, {'ForeName': 'Byron', 'Initials': 'B', 'LastName': 'Gajewski', 'Affiliation': ''}]",Journal of the American Pharmacists Association : JAPhA,['10.1016/j.japh.2019.08.010']
1019,30499929,Preliminary Efficacy of Online Traumatic Brain Injury Professional Development for Educators: An Exploratory Randomized Clinical Trial.,"OBJECTIVE


To examine the efficacy of an online traumatic brain injury (TBI) professional development intervention, In the Classroom After Concussion: Best Practices for Student Success.
DESIGN


A randomized controlled trial with a sample of 100 general educators, who were randomly assigned to the In the Classroom Web site (treatment group) or the LEARNet Web site (control group). Participants completed the pretest, accessed the In the Classroom or LEARNet site and the posttest and completed follow-up assessments 60 days after posttest.
MEASURES


(1) Knowledge of effective strategies for working with students with TBI; (2) knowledge application; (3) self-efficacy in handling situations presented in text and video scenarios, and (4) a standardized self-efficacy measure.
RESULTS


On the posttest assessment, In the Classroom educators showed significantly greater gains in knowledge (P < .0001, d = 1.36 [large effect]), TBI knowledge application (P = .0261, d = 0.46), and general self-efficacy (P = .0106, d = 0.39) than the LEARNet controls. In the Classroom educators maintained significant gains in knowledge (P = .001, d = 0.82) and general self-efficacy (P = .018, d = 0.38) but not in TBI knowledge application (P = .921, d = 0.02).
CONCLUSION


Given the prevalence of TBI, it is important to develop evidence-based, cost-effective approaches to knowledge transfer and exchange in TBI professional development. In the Classroom is one such approach.",2019,"In the Classroom educators maintained significant gains in knowledge (P = .001, d = 0.82) and general self-efficacy (P =","['100 general educators', 'Educators']","['Classroom Web site (treatment group) or the LEARNet Web site (control group', 'Online Traumatic Brain Injury Professional Development', 'online traumatic brain injury (TBI) professional development intervention']","['knowledge', 'TBI knowledge application', 'general self-efficacy', '1) Knowledge of effective strategies for working with students with TBI; (2) knowledge application; (3) self-efficacy', 'gains in knowledge']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0243107', 'cui_str': 'development'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]",100.0,0.0959726,"In the Classroom educators maintained significant gains in knowledge (P = .001, d = 0.82) and general self-efficacy (P =","[{'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'Glang', 'Affiliation': 'The Center on Brain Injury Research and Training, University of Oregon, Eugene.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'McCart', 'Affiliation': ''}, {'ForeName': 'Jody', 'Initials': 'J', 'LastName': 'Slocumb', 'Affiliation': ''}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Gau', 'Affiliation': ''}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Davies', 'Affiliation': ''}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Gomez', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Beck', 'Affiliation': ''}]",The Journal of head trauma rehabilitation,['10.1097/HTR.0000000000000447']
1020,31773444,"Changes in Days of Unhealthy Alcohol Use and Antiretroviral Therapy Adherence, HIV RNA Levels, and Condomless Sex: A Secondary Analysis of Clinical Trial Data.","In a sample of people with HIV (PWH) enrolled in an alcohol intervention trial and followed for 12 months, we examined the association of changes in days (i.e., decrease, increase, no change [reference]) of unhealthy drinking (consuming ≥ 4/≥ 5 drinks for women/men) with antiretroviral therapy adherence (≥ 95% adherent), viral suppression (HIV RNA < 75 copies/mL), condomless sex with HIV-negative/unknown status partners, and dual-risk outcome (HIV RNA ≥ 75 copies/mL plus condomless sex). The sample included 566 PWH (96.8% male; 63.1% White; 93.9% HIV RNA < 75 copies/mL) who completed baseline, 6-, and 12-month assessments. Decrease in days of unhealthy drinking was associated with increased likelihood of viral suppression (odds ratio [OR] 3.78; 95% confidence interval [CI] 1.06, 13.51, P = .04) versus no change. Increase in days of unhealthy drinking was associated with increased likelihood of condomless sex (OR 3.13; 95% CI 1.60, 6.12, P < .001). Neither increase nor decrease were associated with adherence or dual-risk outcome. On a continuous scale, for each increase by 1 day of unhealthy drinking in the prior month, the odds of being 95% adherent decreased by 6% (OR 0.94, 95% CI 0.88, 1.00, P = 0.04).",2020,"Increase in days of unhealthy drinking was associated with increased likelihood of condomless sex (OR 3.13; 95% CI 1.60, 6.12, P < .001).","['for women/men) with antiretroviral therapy adherence (≥\u200995% adherent), viral suppression (HIV RNA\u2009<\u200975 copies/mL), condomless sex with HIV-negative/unknown status partners, and dual-risk outcome (HIV RNA\u2009≥\u200975 copies/mL plus condomless sex', 'The sample included 566 PWH (96.8% male; 63.1% White; 93.9% HIV RNA\u2009<\u200975 copies/mL) who completed baseline, 6-, and 12-month assessments', 'people with HIV (PWH']",['unhealthy drinking (consuming\u2009≥\u20094/≥\u20095 drinks'],"['adherence or dual-risk outcome', 'likelihood of viral suppression', 'Changes in Days of Unhealthy Alcohol Use and Antiretroviral Therapy Adherence, HIV RNA Levels, and Condomless Sex', 'likelihood of condomless sex']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]",566.0,0.042416,"Increase in days of unhealthy drinking was associated with increased likelihood of condomless sex (OR 3.13; 95% CI 1.60, 6.12, P < .001).","[{'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Satre', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA. derek.satre@ucsf.edu.'}, {'ForeName': 'Varada', 'Initials': 'V', 'LastName': 'Sarovar', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Leyden', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Hare', 'Affiliation': 'Department of Adult and Family Medicine, Kaiser Permanente San Francisco Medical Center, San Francisco, CA, USA.'}, {'ForeName': 'Sheryl L', 'Initials': 'SL', 'LastName': 'Catz', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California at Davis, Sacramento, CA, USA.'}, {'ForeName': 'Kendall J', 'Initials': 'KJ', 'LastName': 'Bryant', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Williams', 'Affiliation': 'Health Services Research & Development Center of Innovation for Veteran-Centered and Value-Driven Care, VA Puget Sound, Seattle, WA, USA.'}, {'ForeName': 'J Carlo', 'Initials': 'JC', 'LastName': 'Hojilla', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Horberg', 'Affiliation': 'Mid-Atlantic Permanente Research Institute, Kaiser Permanente Mid-Atlantic States, Rockville, MD, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Silverberg', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02742-y']
1021,31200891,Exercise intervention in the management of urinary incontinence in older women in villages in Bangladesh: a cluster randomised trial.,"BACKGROUND


Group exercise-based programmes for urinary incontinence appear to be promising low-cost interventions for women in developing countries, but no evidence exists to support whether they could be implemented or effective in such populations. We aimed to evaluate whether a group intervention that comprised pelvic floor muscle training, mobility exercises, and bladder education would be more effective than education alone, and report changes between villages (ie, clusters) rather than between individual participants.
METHODS


In this cluster randomised trial, we recruited women from 16 pairs of villages in Bangladesh, with each pair comprising similar villages from the same sub-district. Women aged 60-75 years were interviewed to establish eligibility. Women were eligible if they had current urinary incontinence, and were excluded if they had a third degree or higher uterine prolapse, if they were unable to walk or stand without help, or if they had insufficient intellectual capacity to understand questions and follow instructions. The villages were randomly assigned within each pair to either exercise plus education or education-only intervention by use of a random number generator from a fixed seed. Women were excluded after consenting if they lived too far from the centre of the village. The exercise intervention was a physiotherapist-led group exercise class that was held twice weekly for 12 weeks, with home exercises between classes and to 24 weeks. Both groups received bladder-health education. Participants were followed up for 24 weeks. A 3-day continence record was collected at recruitment and every 4 weeks up until 24 weeks. This record involved the participant tying a knot in ribbons worn under the clothing each time they had an episode of urinary leakage. The primary outcome was change in number of knots (recorded leakage episodes) from recruitment to 24 weeks. Safety was assessed in all participants in the exercise intervention group. The trial is registered at ClinicalTrials.gov, number NCT02453100.
FINDINGS


Between Aug 22, 2015, and July 2, 2018, of 3577 women aged 60-75 years identified, 1003 were eligible, of whom 625 consented to participate (n=335 exercise plus education villages, and n=290 in education-only villages). Of these consenting women, 46 were excluded (n=37 exercise plus education, n=9 education only) because they lived too far from the centre of the village. At week 24, 283 (95%) of 298 in the exercise plus education group and 274 (98%) of 281 in the education-only group completed a 3-day continence record. The estimate of change in number of leakage episodes between baseline and 24 weeks was -7·7 (95% CI -10·6 to -4·8) at the village level in an unadjusted model, and -6·64 (-7·95 to -5·33) in a random-effects model accounting for cluster randomisation. No adverse events were reported.
INTERPRETATION


A structured group-exercise intervention has the potential to manage urinary incontinence in older women in communities largely outside the reach of pharmaceutical or surgical interventions.
FUNDING


Canadian Institutes for Health Research.",2019,"INTERPRETATION


A structured group-exercise intervention has the potential to manage urinary incontinence in older women in communities largely outside the reach of pharmaceutical or surgical interventions.
","['Between Aug 22, 2015, and July 2, 2018, of 3577 women aged 60-75 years identified, 1003 were eligible, of whom 625 consented to participate (n=335 exercise plus education villages, and n=290 in education-only villages', 'Women aged 60-75 years', 'older women in villages in Bangladesh', 'consenting women, 46 were excluded (n=37 exercise plus education, n=9 education only) because they lived too far from the centre of the village', 'older women in communities largely outside the reach of pharmaceutical or surgical interventions', 'recruited women from 16 pairs of villages in Bangladesh, with each pair comprising similar villages from the same sub-district', 'Women were excluded after consenting if they lived too far from the centre of the village', 'Women were eligible if they had current urinary incontinence, and were excluded if they had a third degree or higher uterine prolapse, if they were unable to walk or stand without help, or if they had insufficient intellectual capacity to understand questions and follow instructions']","['exercise intervention', 'pelvic floor muscle training, mobility exercises, and bladder education', 'Exercise intervention', 'exercise plus education or education-only intervention by use of a random number generator from a fixed seed']","['adverse events', 'urinary incontinence', 'number of leakage episodes', 'change in number of knots (recorded leakage episodes', 'Safety']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C4517838', 'cui_str': 'Six hundred and twenty-five'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0067954', 'cui_str': 'TOOS'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0549433', 'cui_str': 'Surgical intervention'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0443323', 'cui_str': 'Third degree (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0042140', 'cui_str': 'Uterine Prolapse'}, {'cui': 'C0560046', 'cui_str': 'Unable to walk (finding)'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0237638', 'cui_str': 'Generator'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0036563', 'cui_str': 'Zygotes, Plant'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",3577.0,0.27217,"INTERPRETATION


A structured group-exercise intervention has the potential to manage urinary incontinence in older women in communities largely outside the reach of pharmaceutical or surgical interventions.
","[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wagg', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Zafrullah', 'Initials': 'Z', 'LastName': 'Chowdhury', 'Affiliation': 'Gonoshasthaya Kendra, Savar, Bangladesh.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Galarneau', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Rezaul', 'Initials': 'R', 'LastName': 'Haque', 'Affiliation': 'Gonoshasthaya Kendra, Savar, Bangladesh; Department of Social Medicine, Gono Bishwabidyalay University, Savar, Bangladesh.'}, {'ForeName': 'Fardous', 'Initials': 'F', 'LastName': 'Kabir', 'Affiliation': 'Gonoshasthaya Kendra, Savar, Bangladesh.'}, {'ForeName': 'Dianna', 'Initials': 'D', 'LastName': 'MacDonald', 'Affiliation': 'Lois Hole Hospital for Women, Edmonton, AB, Canada.'}, {'ForeName': 'Kamrun', 'Initials': 'K', 'LastName': 'Naher', 'Affiliation': 'Gonoshasthaya Kendra, Savar, Bangladesh; Department of Physiotherapy, Gono Bishwabidyalay University, Savar, Bangladesh.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Yasui', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Cherry', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, University of Alberta, Edmonton, AB, Canada. Electronic address: nicola.cherry@ualberta.ca.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30205-0']
1022,31200893,Efficacy of inactivated trivalent influenza vaccine in rural India: a 3-year cluster-randomised controlled trial.,"BACKGROUND


Paediatric vaccination against influenza can result in indirect protection, by reducing transmission to their unvaccinated contacts. We investigated whether influenza vaccination of children would protect them and their household members in a resource-limited setting.
METHODS


We did a cluster-randomised, blinded, controlled study in three villages in India. Clusters were defined as households (ie, dwellings that shared a courtyard), and children aged 6 months to 10 years were eligible for vaccination as and when they became age-eligible throughout the study. Households were randomly assigned (1:1) by a computer-based system to intramuscular trivalent inactivated influenza vaccine (IIV3) or a control of inactivated poliovirus vaccine (IPV) in the beginning of the study; vaccination occurred once a year for 3 years. The primary efficacy outcome was laboratory-confirmed influenza in a vaccinated child with febrile acute respiratory illness, analysed in the modified intention-to-treat population (ie, children who received at least one dose of vaccine, were under surveillance, and had not an influenza infection within 15 days of last vaccine dose). The secondary outcome for indirect effectiveness (surveillance study) was febrile acute respiratory illness in an unvaccinated household member of a vaccine study participant. Data from each year (year 1: November, 2009, to October, 2010; year 2: October, 2010, to October, 2011; and year 3: October, 2011, to May, 2012) were analysed separately. Safety was analysed among all participants who were vaccinated with at least one dose of the vaccine. This trial is registered with ClinicalTrials.gov, number NCT00934245.
FINDINGS


Between Nov 1, 2009, to May 1, 2012, we enrolled 3208 households, of which 1959 had vaccine-eligible children. 1010 households were assigned to IIV3 and 949 households were assigned to IPV. In 3 years, we vaccinated 4345 children (2132 with IIV3 and 2213 with IPV) from 1868 households (968 with IIV3 and 900 with IPV) with 10 813 unvaccinated household contacts. In year 1, influenza virus was detected in 151 (10%) of 1572 IIV3 recipients and 206 (13%) of 1633 of IPV recipients (total IIV3 vaccine efficacy 25·6% [95% CI 6·8-40·6]; p=0·010). In year 2, 105 (6%) of 1705 IIV3 recipients and 182 (10%) of 1814 IPV recipients had influenza (vaccine efficacy 41·0% [24·1-54·1]; p<0·0001). In year 3, 20 (1%) of 1670 IIV3 recipients and 81 (5%) of 1786 IPV recipients had influenza (vaccine efficacy 74·2% [57·8-84·3]; p<0·0001). In year 1, total vaccine efficacy against influenza A(H1N1)pdm09 was 14·5% (-20·4 to 39·3). In year 2, total vaccine efficacy against influenza A(H3N2) was 64·5% (48·5-75·5). Total vaccine efficacy against influenza B was 32·5% (11·3-48·6) in year 1, 4·9% (-38·9 to 34·9) in year 2, and 76·5% (59·4-86·4) in year 3. Indirect vaccine effectiveness was statistically significant only in year 3 (38·1% [7·4-58·6], p=0·0197) when influenza was detected in 39 (1%) of 4323 IIV3-allocated and 60 (1%) of 4121 IPV-allocated household unvaccinated individuals. In the IIV3 group, 225 (12%) of 1632 children in year 1, 375 (22%) of 1718 in year 2, and 209 (12%) of 1673 in year 3 had an adverse reaction (compared with 216 [13%] of 1730, 380 [21%] of 1825, and 235 [13%] of 1796, respectively, in the IPV group). The most common reactions in both groups were fever and tenderness at site. No vaccine-related deaths occurred in either group.
INTERPRETATION


IIV3 provided variable direct and indirect protection against influenza infection. Indirect protection was significant during the year of highest direct protection and should be considered when quantifying the effect of vaccination programmes.
FUNDING


US Centers for Disease Control and Prevention.",2019,"Total vaccine efficacy against influenza B was 32·5% (11·3-48·6) in year 1, 4·9% (-38·9 to 34·9) in year 2, and 76·5% (59·4-86·4) in year 3.","['1010 households were assigned to IIV3 and 949 households were assigned to', '4345 children (2132 with IIV3 and 2213 with IPV) from 1868 households (968 with IIV3 and 900 with IPV) with 10\u2008813 unvaccinated household contacts', 'enrolled 3208 households, of which 1959 had vaccine-eligible children', 'households (ie, dwellings that shared a courtyard), and children aged 6 months to 10 years were eligible for vaccination as and when they became age-eligible throughout the study', 'children would protect them and their household members in a resource-limited setting', 'rural India', 'participants who were vaccinated with at least one dose of the vaccine', 'three villages in India']","['inactivated trivalent influenza vaccine', 'IPV', 'computer-based system to intramuscular trivalent inactivated influenza vaccine (IIV3) or a control of inactivated poliovirus vaccine (IPV']","['Efficacy', 'Indirect vaccine effectiveness', 'febrile acute respiratory illness', 'Total vaccine efficacy', 'total vaccine efficacy', 'deaths', 'Safety', 'adverse reaction']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0150269', 'cui_str': 'Limit setting (procedure)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}]","[{'cui': 'C0770694'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0718003', 'cui_str': 'Poliovirus Vaccine, Inactivated'}]","[{'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",3208.0,0.452958,"Total vaccine efficacy against influenza B was 32·5% (11·3-48·6) in year 1, 4·9% (-38·9 to 34·9) in year 2, and 76·5% (59·4-86·4) in year 3.","[{'ForeName': 'Wayne M', 'Initials': 'WM', 'LastName': 'Sullender', 'Affiliation': 'Department of Pediatrics, School of Medicine, and Center for Global Health, School of Public Health, University of Colorado Denver, Denver, CO, USA. Electronic address: wayne.sullender@ucdenver.edu.'}, {'ForeName': 'Karen B', 'Initials': 'KB', 'LastName': 'Fowler', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Community Ophthalmology Department, All India Institute of Medical Sciences, Delhi, India.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Krishnan', 'Affiliation': 'Centre for Community Medicine, All India Institute of Medical Sciences, Delhi, India.'}, {'ForeName': 'Debjani', 'Initials': 'D', 'LastName': 'Ram Purakayastha', 'Affiliation': 'Centre for Community Medicine, All India Institute of Medical Sciences, Delhi, India.'}, {'ForeName': 'Raghuram', 'Initials': 'R', 'LastName': 'Srungaram Vln', 'Affiliation': 'Microbiology Department, All India Institute of Medical Sciences, Delhi, India.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Lafond', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Siddhartha', 'Initials': 'S', 'LastName': 'Saha', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Francisco S', 'Initials': 'FS', 'LastName': 'Palomeque', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gargiullo', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Renu', 'Initials': 'R', 'LastName': 'Lal', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Marc-Alain', 'Initials': 'MA', 'LastName': 'Widdowson', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Broor', 'Affiliation': 'Microbiology Department, All India Institute of Medical Sciences, Delhi, India.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30079-8']
1023,31784747,Biomarkers and Noncalcified Coronary Artery Plaque Progression in Older Men Treated With Testosterone.,"OBJECTIVE


Recent results from the Cardiovascular Trial of the Testosterone Trials showed that testosterone treatment of older men with low testosterone was associated with greater progression of noncalcified plaque (NCP). We evaluated the effect of anthropometric measures and cardiovascular biomarkers on plaque progression in individuals in the Testosterone Trial.
METHODS


The Cardiovascular part of the trial included 170 men aged 65 years or older with low testosterone. Participants received testosterone gel or placebo gel for 12 months. The primary outcome was change in NCP volume from baseline to 12 months, as determined by coronary computed tomography angiography (CCTA). We assayed several markers of cardiovascular risk and analyzed each marker individually in a model as predictive variables and change in NCP as the dependent variable.
RESULTS


Of 170 enrollees, 138 (73 testosterone, 65 placebo) completed the study and were available for the primary analysis. Of 10 markers evaluated, none showed a significant association with the change in NCP volume, but a significant interaction between treatment assignment and waist-hip ratio (WHR) (P = 0.0014) indicated that this variable impacted the testosterone effect on NCP volume. The statistical model indicated that for every 0.1 change in the WHR, the testosterone-induced 12-month change in NCP volume increased by 26.96 mm3 (95% confidence interval, 7.72-46.20).
CONCLUSION


Among older men with low testosterone treated for 1 year, greater WHR was associated with greater NCP progression, as measured by CCTA. Other biomarkers and anthropometric measures did not show statistically significant association with plaque progression.",2020,Other biomarkers and anthropometric measures did not show statistically significant association with plaque progression.,"['individuals in the T Trial', '170 men aged 65 years or older with low T. Participants received', 'older men', 'Older Men Treated with', '170 enrollees', 'older men with low T']","['Testosterone(T', 'T gel or placebo gel', 'Testosterone']","['change in NCP volume', 'waist-hip ratio', 'NCP volume', 'coronary computed tomography angiography (CCTA', 'testosterone effect on non-calcified plaque volume', 'non-calcified plaque volume', 'plaque progression', 'progression of non-calcified plaque (NCP']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",170.0,0.301467,Other biomarkers and anthropometric measures did not show statistically significant association with plaque progression.,"[{'ForeName': 'Kashif', 'Initials': 'K', 'LastName': 'Shaikh', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Ellenberg', 'Affiliation': 'Department of Biostatistics and Epidemiology, Perelman School of Medicine at The University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Rine', 'Initials': 'R', 'LastName': 'Nakanishi', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Snyder', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Juhwan', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Nanette K', 'Initials': 'NK', 'LastName': 'Wenger', 'Affiliation': 'Department of Medicine, Division of Cardiology, Emory Heart and Vascular Center Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Division of Preventive Medicine, University of Alabama at Birmingham, Alabama.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Swerdloff', 'Affiliation': 'Division of Endocrinology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Preston', 'Affiliation': 'Department of Biostatistics and Epidemiology, Perelman School of Medicine at The University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Sajad', 'Initials': 'S', 'LastName': 'Hamal', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Alisa', 'Initials': 'A', 'LastName': 'Stephens-Sheilds', 'Affiliation': 'Department of Biostatistics and Epidemiology, Perelman School of Medicine at The University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Shalender', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': 'Department of Family and Preventive Medicine, Division of Epidemiology, University of California, San Diego School of Medicine, La Jolla, California.'}, {'ForeName': 'Lavanya', 'Initials': 'L', 'LastName': 'Cherukuri', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Cauley', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Graduate School of Public Health, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jill P', 'Initials': 'JP', 'LastName': 'Crandall', 'Affiliation': 'Divisions of Endocrinology and Geriatrics, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Glenn R', 'Initials': 'GR', 'LastName': 'Cunningham', 'Affiliation': ""Departments of Medicine and Molecular & Cellular Biology, Division of Diabetes, Endocrinology and Metabolism, Baylor College of Medicine and Baylor St. Luke's Medical Center, Houston, Texas.""}, {'ForeName': 'Kristine E', 'Initials': 'KE', 'LastName': 'Ensrud', 'Affiliation': 'Department of Medicine, Division of Epidemiology & Community Health, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Alvin M', 'Initials': 'AM', 'LastName': 'Matsumoto', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, Department of Veterans Affairs, Puget Sound Health System, and Division of Gerontology and Geriatric Medicine, Department of Internal Medicine, University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Molich', 'Affiliation': 'Division of Endocrinology, Metabolism and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Venkata M', 'Initials': 'VM', 'LastName': 'Alla', 'Affiliation': 'Division of Cardiovascular Diseases, Creighton University School of Medicine, Omaha, Nebraska.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Birudaraju', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Nezarat', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Kelash', 'Initials': 'K', 'LastName': 'Rai', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Shone', 'Initials': 'S', 'LastName': 'Almeida', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Sion K', 'Initials': 'SK', 'LastName': 'Roy', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sheikh', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Trad', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Mathew J', 'Initials': 'MJ', 'LastName': 'Budoff', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz242']
1024,30499926,A Comparison of 2 Online Parent Skills Training Interventions for Early Childhood Brain Injury: Improvements in Internalizing and Executive Function Behaviors.,"OBJECTIVE


To examine the effectiveness of a web-based parenting intervention (Internet-Based Interacting Together Everyday: Recovery After Childhood TBI [I-InTERACT]) and an abbreviated version (Express) in reducing executive dysfunction and internalizing problems among young children following traumatic brain injury (TBI).
METHOD


Parents of 113 children (ages 3-9 years) who had sustained a TBI were randomized to 1 of 3 treatment groups: I-InTERACT, Express, or an Internet Resource Comparison (IRC) group. Parents who participated in either I-InTERACT or Express completed self-guided web sessions and received live coaching of their parenting skills via videoconferencing with a therapist. I-InTERACT included additional psychoeducation, stress management, and family communication skills (eg, marriage, grief, pain, and sleep). Analyses of covariance were utilized to compare the groups on parent-reported executive function behaviors (ie, Behavior Rating Inventory of Executive Function) and internalizing symptoms (ie, Child Behavior Checklist) at baseline and 6 months.
RESULTS


Parents who participated in Express reported significantly lower levels of executive dysfunction than those in I-InTERACT, β = -0.49; t(2, 73) = -2.47, P = .048, and significantly lower levels of withdrawal than those in the IRC group, β = -0.44; t(2, 74) = -2.22, P = .03. The Express group did not significantly differ from the IRC group on executive function behaviors or the I-InTERACT group on internalizing problems, all P > .05. Children with more problems at baseline, families with lower education levels, and parents with more symptoms of depression benefited most.
CONCLUSION


A brief, online parent training intervention may be efficacious in improving executive dysfunction and internalizing problems following early TBI, particularly among children of lower socioeconomic status or with existing behavioral concerns.",2019,"The Express group did not significantly differ from the IRC group on executive function behaviors or the I-InTERACT group on internalizing problems, all P > .05.","['Everyday', 'young children following traumatic brain injury (TBI', 'Parents of 113 children (ages 3-9 years) who had sustained a TBI', 'Early Childhood Brain Injury', 'After Childhood TBI', 't(2, 74) ', ' t(2, 73) ']","['web-based parenting intervention (Internet-Based Interacting Together', 'Internet Resource Comparison (IRC) group', 'online parent training intervention', 'abbreviated version (Express', 'live coaching of their parenting skills via videoconferencing with a therapist', 'IRC', '2 Online Parent Skills Training Interventions']","['family communication skills (eg, marriage, grief, pain, and sleep', 'Recovery', 'executive function behaviors', 'levels of withdrawal', 'executive dysfunction and internalizing problems', 'levels of executive dysfunction', 'executive function behaviors (ie, Behavior Rating Inventory of Executive Function) and internalizing symptoms (ie, Child Behavior Checklist']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0018235', 'cui_str': 'Grief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2748208', 'cui_str': 'Executive dysfunction'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",113.0,0.0494341,"The Express group did not significantly differ from the IRC group on executive function behaviors or the I-InTERACT group on internalizing problems, all P > .05.","[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Aguilar', 'Affiliation': ""Division of Physical Medicine and Rehabilitation (Drs Aguilar and Wade and Ms Shultz) and Division of Biostatistics and Epidemiology (Dr Cassedy), Cincinnati Children's Hospital Medical Center, Ohio; University of Cincinnati, Ohio (Ms Shultz and Dr Wade); Children's Hospital Colorado, Denver (Dr Kirkwood); Metrohealth Medical Center, Cleveland, Ohio (Dr Stancin); Case Western Reserve University, Cleveland, Ohio (Drs Stancin and Taylor); Department of Pediatrics and Clinical Neurosciences, University of Calgary, Ontario (Dr Yeates); and Rainbow Babies and Children's Hospital, University Hospitals Case Medical Center, Cleveland, Ohio (Dr Taylor).""}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Cassedy', 'Affiliation': ''}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Shultz', 'Affiliation': ''}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Kirkwood', 'Affiliation': ''}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Stancin', 'Affiliation': ''}, {'ForeName': 'Keith Owen', 'Initials': 'KO', 'LastName': 'Yeates', 'Affiliation': ''}, {'ForeName': 'H Gerry', 'Initials': 'HG', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Wade', 'Affiliation': ''}]",The Journal of head trauma rehabilitation,['10.1097/HTR.0000000000000443']
1025,31766273,Natural Choline from Egg Yolk Phospholipids Is More Efficiently Absorbed Compared with Choline Bitartrate; Outcomes of A Randomized Trial in Healthy Adults.,"Choline is a vitamin-like essential nutrient, important throughout one's lifespan. Therefore, choline salts are added to infant formula, supplements and functional foods. However, if choline is present in a natural form, e.g. bound to phospholipids, it may be more efficiently absorbed. The study's aim was to evaluate if choline uptake is improved after consumption of an egg yolk phospholipid drink, containing 3 g of phospholipid bound choline, compared to a control drink with 3 g of choline bitartrate. We performed a randomized, double blind, cross-over trial with 18 participants. Plasma choline, betaine and dimethylglycine concentrations were determined before and up to six hours after consumption of the drinks. The plasma choline response, as determined by the incremental area under the curve, was four times higher after consumption of the egg yolk phospholipid drink compared with the control drink ( p <  0.01). Similar outcomes were also observed for choline's main metabolites, betaine ( p <  0.01) and dimethylglycine ( p =  0.01). Consumption of natural choline from egg yolk phospholipids improved choline absorption compared to consumption of chemically produced choline bitartrate. This information is of relevance for the food industry, instead of adding choline-salts, adding choline from egg yolk phospholipids can improve choline uptake and positively impact health.",2019,"Similar outcomes were also observed for choline's main metabolites, betaine ( p <  0.01) and dimethylglycine ( p =  0.01).","['Healthy Adults', '18 participants']","['control drink with 3 g of choline bitartrate', 'Choline', 'Choline Bitartrate', 'choline salts']","['Plasma choline, betaine and dimethylglycine concentrations', 'plasma choline response']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0008408', 'cui_str': 'Choline Bitartrate'}, {'cui': 'C0008405', 'cui_str': 'Choline'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0058265', 'cui_str': 'glycine, N,N-dimethyl-'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.169534,"Similar outcomes were also observed for choline's main metabolites, betaine ( p <  0.01) and dimethylglycine ( p =  0.01).","[{'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Smolders', 'Affiliation': 'AAK, Department of Special Nutrition, AAK Netherlands BV, Zaandijk, Kreeftstraat 1, 1544 CK Zaandijk, The Netherlands.'}, {'ForeName': 'Nicole J W', 'Initials': 'NJW', 'LastName': 'de Wit', 'Affiliation': 'Wageningen Food and Biobased Research, Wageningen University & Research, 6708 WG Wageningen, The Netherlands.'}, {'ForeName': 'Michiel G J', 'Initials': 'MGJ', 'LastName': 'Balvers', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University and Research, 6708 WE Wageningen, The Netherlands.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Obeid', 'Affiliation': 'Department of Clinical Chemistry and Laboratory Medicine, Saarland University Hospital, D-66421 Homburg, Germany.'}, {'ForeName': 'Marc M M', 'Initials': 'MMM', 'LastName': 'Vissers', 'Affiliation': 'AAK, Department of Special Nutrition, AAK Netherlands BV, Zaandijk, Kreeftstraat 1, 1544 CK Zaandijk, The Netherlands.'}, {'ForeName': 'Diederik', 'Initials': 'D', 'LastName': 'Esser', 'Affiliation': 'Wageningen Food and Biobased Research, Wageningen University & Research, 6708 WG Wageningen, The Netherlands.'}]",Nutrients,['10.3390/nu11112758']
1026,32410463,Empagliflozin in Heart Failure: Diuretic and Cardio-Renal Effects.,"Background:  Sodium-glucose cotransporter-2 inhibitors (SGLT-2i's) improve heart failure (HF) related outcomes. The mechanisms underlying these benefits are not well understood, but diuretic properties may contribute. Traditional diuretics, such as furosemide, induce substantial neurohormonal activation contributing to the limited improvement in intravascular volume often seen with these agents. However, the proximal tubular site of action of the SGLT-2i's may help circumvent these limitations.  Methods:  20 patients with type-2 diabetes and chronic, stable HF completed a randomized placebo-controlled crossover study of empagliflozin 10mg daily vs. placebo. Patients underwent an intensive 6-hour biospecimen collection and cardio-renal phenotyping at baseline and again after 14 days of study drug. After a 2-week washout, patients crossed over to the alternate therapy with repeat of the above protocol.  Results:  Oral empagliflozin was rapidly absorbed as evidenced by a 27-fold increase in urinary glucose excretion by 3 hours (p<0.0001). Fractional excretion of sodium (FENa) increased significantly with empagliflozin monotherapy vs. placebo (FENa 1.2 ± 0.7% vs. 0.7 ± 0.4% p=0.001) and there was a synergistic effect in combination with bumetanide (FENa 5.8 ± 2.5% vs. 3.9 ± 1.9%, p=0.001). At 14 days, the natriuretic effect of empagliflozin persisted, resulting in a reduction in blood volume (-208mL, IQR -536 to 153 mL vs -14mL, IQR -282 to 335 mL, p=0.035), and plasma volume (-138mL, IQR -379 to 154mL ± 453 mL, p=0.04). This natriuresis was not, however, associated with evidence of neurohormonal activation as change in norepinephrine was superior (p = 0.02) and all other neurohormones similar (p<0.34) during the empagliflozin vs. placebo period. Furthermore, there was no evidence of potassium wasting (p=0.20), or renal dysfunction (p>0.11 for all biomarkers), whereas both serum magnesium (p<0.001) and uric acid levels (p=0.008) improved.  Conclusions: Empagliflozin causes significant natriuresis, particularly when combined with loop diuretics, resulting in an improvement in blood volume. However, off-target electrolyte wasting, renal dysfunction, and neurohormonal activation were not observed. This favorable diuretic profile may offer significant advantage in the management of volume status in HF patients and may represent a mechanism contributing to the superior long-term HF outcomes observed with these agents.  Clinical Trial Registration:  URL: https://clinicaltrials.gov Unique Identifier: NCT03029760.",2020,"Fractional excretion of sodium (FENa) increased significantly with empagliflozin monotherapy vs. placebo (FENa 1.2 ± 0.7% vs. 0.7 ± 0.4% p=0.001) and there was a synergistic effect in combination with bumetanide (FENa 5.8 ± 2.5% vs. 3.9 ± 1.9%, p=0.001).","['HF patients', '20 patients with type-2 diabetes and chronic, stable HF completed a randomized', 'Heart Failure']","['bumetanide', 'empagliflozin', 'empagliflozin monotherapy vs. placebo', ""Sodium-glucose cotransporter-2 inhibitors (SGLT-2i's"", 'intensive 6-hour biospecimen collection and cardio-renal phenotyping', 'Empagliflozin', 'Oral empagliflozin', 'empagliflozin vs. placebo', 'empagliflozin 10mg daily vs. placebo', 'placebo']","['plasma volume', 'urinary glucose excretion', 'serum magnesium (p<0.001) and uric acid levels', 'synergistic effect', 'Fractional excretion of sodium (FENa', 'blood volume', 'renal dysfunction', 'renal dysfunction, and neurohormonal activation', 'natriuretic effect', 'potassium wasting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0006376', 'cui_str': 'Bumetanide'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3848773', 'cui_str': 'empagliflozin 10 MG [Jardiance]'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0428601', 'cui_str': 'Measurement of fractional excretion of sodium'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C3179308', 'cui_str': 'Natriuretic Effects'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}]",20.0,0.14824,"Fractional excretion of sodium (FENa) increased significantly with empagliflozin monotherapy vs. placebo (FENa 1.2 ± 0.7% vs. 0.7 ± 0.4% p=0.001) and there was a synergistic effect in combination with bumetanide (FENa 5.8 ± 2.5% vs. 3.9 ± 1.9%, p=0.001).","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Griffin', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Veena S', 'Initials': 'VS', 'LastName': 'Rao', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Ivey-Miranda', 'Affiliation': 'Hospital de Cardiologia, Instituto Mexicano del Seguro Social, Mexico City, Mexico.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Fleming', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Mahoney', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Maulion', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Suda', 'Affiliation': 'Montefiore Medical Center, Albert Einstein College of Medicine, New York, NY.'}, {'ForeName': 'Krishmita', 'Initials': 'K', 'LastName': 'Siwakoti', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Diabetes and Metabolism, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Ahmad', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jacoby', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Riello', 'Affiliation': 'Division of Pharmacy, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Lavanya', 'Initials': 'L', 'LastName': 'Bellumkonda', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Cox', 'Affiliation': 'Department of Pharmacy Practice, Lipscomb University College of Pharmacy, Nashville, TN.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Collins', 'Affiliation': 'Deparment of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Sangchoon', 'Initials': 'S', 'LastName': 'Jeon', 'Affiliation': 'Yale School of Nursing, West Haven, CT.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Turner', 'Affiliation': 'Department of Medicine, Division of Nephrology, Yale University School of Medicine, New Haven CT.'}, {'ForeName': 'F Perry', 'Initials': 'FP', 'LastName': 'Wilson', 'Affiliation': 'Program of Applied Translational Research, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi, Jackson, MS.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Department of Internal Medicine, Section of Endocrinology, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Testani', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, CT.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.045691']
1027,30721647,"Randomised controlled trial of a brief, clinic-based intervention to promote safer sex among young Black men who have sex with men: implications for pre-exposure prophylaxis-related counselling.","Background The aim of this study was to determine the 3-month efficacy of a single-session, clinic-based intervention promoting condom use for anal and oral sex among HIV-uninfected Black young men who have sex with men (YBMSM).
METHODS


A pre-post test randomised controlled trial (RCT) was conducted from 2012 to 2015 using a 3-month period of observation. Recruitment and assessment occurred in sexually transmissible infection (STI) clinics. Men were randomised to either the intervention condition (n=142) or a standard-of-care control condition (n=135). The experimental condition comprised a single session of a one-to-one program designed for use in STI clinics. YBMSM completed both baseline and 3-month follow-up assessments. Outcomes measures were condomless anal insertive sex, condomless anal receptive sex and condomless oral sex.
RESULTS


Among men receiving the intervention, 11.2% (n=15) reported any condomless anal insertive sex at follow-up, compared with 20.6% (n=27) among controls (rate ratio=0.54, P=0.04). In addition, 12.0% (n=17) of men receiving the intervention reported any condomless anal receptive sex at follow-up, compared with 21.6% (n=29) among controls (rate ratio=0.55, P=0.03). When combining insertive and receptive anal sex, 18.3% (n=26) of men receiving the intervention reported any condomless sex, compared with 31.1% (n=42) among controls (rate ratio=0.59, P=0.01). Furthermore, 45.8% (n=33) of men receiving the intervention reported any condomless oral sex at follow-up, compared with 63.2% (n=48) among controls (rate ratio=0.72, P=0.03).
CONCLUSIONS


This analysis of data from a Phase 3 RCT suggests that a single session of a clinic-based behavioural intervention may effectively promote the consistent use of condoms for anal and oral sex among HIV-uninfected YBMSM. The single-session program may be a valuable counselling tool for use in conjunction with recommended quarterly clinic appointments for YBMSM using pre-exposure prophylaxis.",2019,"Among men receiving the intervention, 11.2% (n=15) reported any condomless anal insertive sex at follow-up, compared with 20.6% (n=27) among controls (rate ratio=0.54, P=0.04).","['HIV-uninfected Black young men who have sex with men (YBMSM', '2012 to 2015 using a 3-month period of observation', 'young Black men who have sex with men']","['clinic-based intervention', 'single-session, clinic-based intervention promoting condom', 'intervention condition (n=142) or a standard-of-care control condition']","['condomless anal receptive sex', 'condomless anal insertive sex, condomless anal receptive sex and condomless oral sex', 'condomless oral sex', 'condomless anal insertive sex']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2939124', 'cui_str': 'Anal (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0282348', 'cui_str': 'Oral Sex'}]",,0.0530849,"Among men receiving the intervention, 11.2% (n=15) reported any condomless anal insertive sex at follow-up, compared with 20.6% (n=27) among controls (rate ratio=0.54, P=0.04).","[{'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Crosby', 'Affiliation': 'College of Public Health at the University of Kentucky, 111 Washington Avenue, Lexington, KY 40506-0003, USA; and Kinsey Institute for Research in Sex, Gender, and Reproduction, Indiana University, Bloomington, IN 47408, USA; and University of Mississippi Medical Center, 2500 North State Street, Jackson, MS 39216, USA; and Corresponding author. Email: crosbyr3@gmail.com.'}, {'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Mena', 'Affiliation': 'University of Mississippi Medical Center, 2500 North State Street, Jackson, MS 39216, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Vickers Smith', 'Affiliation': 'College of Public Health at the University of Kentucky, 111 Washington Avenue, Lexington, KY 40506-0003, USA; and Present address: University of Louisville, School of Nursing, Louisville, KY 40292, USA.'}]",Sexual health,['10.1071/SH18156']
1028,31013499,Effects of Acupuncture Treatment on Lower Limb Spasticity in Patients Following Hemorrhagic Stroke: A Pilot Study.,"BACKGROUND AND PURPOSE


Lower limb spasticity is often a significant problem in stoke rehabilitation. The purpose of this study was to investigate the effects of acupuncture treatment on lower limb spasticity in patients following hemorrhagic stroke.
METHODS


Fifty-nine patients following hemorrhagic stroke were randomized to receive acupuncture treatment combined with conventional treatment (treatment group [TG]) or conventional treatment only (control group [CG]). Acupuncture treatments were given in 24 sessions over 4 weeks. Blinded evaluation was based on Modified Ashworth Scale (MAS), short intracortical inhibition (SICI), and Hmax/Mmax ratio as the primary outcomes. In addition, Fugl-Meyer Assessment (FMA), Barthel Index (BI), motor evoked potential (MEP) and surface integrated electromyogram (IEMG) were employed as the secondary outcomes. All the evaluations were performed at 14 and 28 days after the start of the treatment.
RESULTS


Compared with the CG, the TG showed a significantly greater over-time decrease in MAS for knee (p = 0.022) and ankle (p = 0.017), SICI (p = 0.000) and Hmax/Mmax ratio (p = 0.000). In all patients of TG, we found a greater improvement in lower-limb FMA and MEP but not in BI. IEMG show that TG obtained a greater reduction in spastic agonist muscles and a greater enhancement in spastic antagonist muscles. A significant correlation between a greater decrease in ankle MAS and a greater increase in SICI for spastic muscles was found (r = 0.390, p = 0.002).
CONCLUSIONS


Acupuncture could improve the lower limb spasticity and motor function, thus providing a safe and economical approach for treating stroke patients. The potential mechanism underpinning the greater improvement may be attributed to a reshape of corticospinal plasticity induced by acupuncture.",2019,"A significant correlation between a greater decrease in ankle MAS and a greater increase in SICI for spastic muscles was found (r = 0.390, p = 0.002).
","['patients following hemorrhagic stroke', 'Fifty-nine patients following hemorrhagic stroke', 'Patients Following Hemorrhagic Stroke']","['Acupuncture Treatment', 'acupuncture treatment combined with conventional treatment (treatment group [TG]) or conventional treatment only (control group [CG', 'Acupuncture', 'IEMG', 'acupuncture']","['spastic agonist muscles', 'SICI for spastic muscles', 'limb spasticity', 'Lower Limb Spasticity', 'Modified Ashworth Scale (MAS), short intracortical inhibition (SICI), and Hmax/Mmax ratio', 'lower-limb FMA and MEP', 'spastic antagonist muscles', 'Fugl-Meyer Assessment (FMA), Barthel Index (BI), motor evoked potential (MEP) and surface integrated electromyogram (IEMG', 'MAS for knee', 'Hmax/Mmax ratio', 'ankle MAS', 'SICI', 'lower limb spasticity and motor function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}, {'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}]","[{'cui': 'C0394664', 'cui_str': 'Acupuncture Treatment'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0443306', 'cui_str': 'Spastic'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C1271100', 'cui_str': 'Lower limb spasticity'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale (assessment scale)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}]",59.0,0.107652,"A significant correlation between a greater decrease in ankle MAS and a greater increase in SICI for spastic muscles was found (r = 0.390, p = 0.002).
","[{'ForeName': 'Hai-Qiao', 'Initials': 'HQ', 'LastName': 'Wang', 'Affiliation': 'Department of Traditional Chinese Medicine, South Campus, Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China, haiqiaodr@163.com.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Hou', 'Affiliation': ""Department of Neurology and Rehabilitation, Qingdao Women and Children's Hospital, Qingdao University, Qingdao, China.""}, {'ForeName': 'Chun-Ling', 'Initials': 'CL', 'LastName': 'Bao', 'Affiliation': 'Department of Acupuncture, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Min', 'Affiliation': 'Department of Traditional Chinese Medicine, South Campus, Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Traditional Chinese Medicine, South Campus, Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.'}]",European neurology,['10.1159/000499133']
1029,32410543,The Value of Low-dose Prospective Dual-energy Computed Tomography with Iodine Mapping in the Diagnosis of Gastric Cancer.,"OBJECTIVES


This study investigated the radiation dose and value of prospective dualenergy computed tomography (DECT) in the diagnosis of gastric cancer.
METHODS


Sixty patients scheduled for computed tomography (CT) for preoperative staging were divided into two groups. Thirty patients (Group A) underwent a single contrast-enhanced abdominal CT acquisition using a dual-source mode (100 kV/140 kV). Weighted average images of the two-kilovolt acquisitions and iodine maps were created. The remaining 30 patients underwent a standard CT scan (Group B). Two observers performed a blinded read of the images for gastric lesions, evaluating the image quality and recording effective dose.
RESULTS


During the blinded read, observers found 90% (27/30) of the cancers in both groups. The mean imaging quality scores were 2.1±0.9 for Group A, and 2.3±1.1 for Group B. The effective mean doses were 6.59±0.59 mSv and 25.86±0.44 mSv for Groups A and B, respectively. Compared with the control group (B), the imaging quality in the low-dose group decreased a little, but the radiation dose substantially decreased by 74.6%.
CONCLUSION


The new DECT technique is valuable for examining gastric cancer patients. The dualkV scan mode can substantially reduce radiation dose while preserving good diagnostic image quality.",2020,"Compared with the control group (B), the imaging quality in the low-dose group decreased a little, but the radiation dose substantially decreased by 74.6%.
","['Thirty patients (Group A) underwent a', 'Sixty patients scheduled for computed tomography (CT) for preoperative staging', 'gastric cancer patients']","['Dual-energy Computed Tomography with Iodine Mapping', 'single contrast-enhanced abdominal CT acquisition using a dual-source mode', 'dualenergy computed tomography (DECT', 'standard CT scan']","['imaging quality', 'mean imaging quality scores']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}]","[{'cui': 'C4055114', 'cui_str': 'Dual energy computed tomography'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0445261', 'cui_str': 'Single contrast technique'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.014807,"Compared with the control group (B), the imaging quality in the low-dose group decreased a little, but the radiation dose substantially decreased by 74.6%.
","[{'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Intervention, The First People's Hospital of Wujiang District, Suzhou, China.""}, {'ForeName': 'Xingxing', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': ""Department of Gastroenterology, the First People's Hospital of Yancheng, Yancheng, China.""}, {'ForeName': 'Zhenguo', 'Initials': 'Z', 'LastName': 'Qiao', 'Affiliation': ""Department of Gastroenterology, The First People's Hospital of Wujiang District, Suzhou, China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ""Department of Intervention, The First People's Hospital of Wujiang District, Suzhou, China.""}, {'ForeName': 'Jiaqing', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}]",Current medical imaging,['10.2174/1573405614666181023114051']
1030,31192515,Masseter corticomotor excitability is decreased after intramuscular administration of nerve growth factor.,"BACKGROUND


Quantification of motor-evoked potentials (MEPs) can contribute to better elucidate the central modulation of motor pathways in response to nociceptive inputs. The primary aim of this study was to assess the modulatory effects of nerve growth factor (NGF) injection on masseter corticomotor excitability.
METHODS


The healthy participants of this randomized, double blind placebo-controlled experiment were assigned to have injected into the right masseter muscle either NGF (n = 25) or isotonic saline (IS, n = 17). The following variables were assessed at baseline and 48 hr after the injection: right masseter MEP amplitude and corticomotor mapping and clinical assessment of jaw pain intensity and function. Repeated Measures ANOVA was applied to the data.
RESULTS


NGF caused jaw pain and increased jaw functional disability after the injection (p < 0.050). Also, the participants in the NGF group decreased the MEP amplitude (p < 0.001) but the IS group did not present any significant modulation after the injection (p > 0.050). Likewise, the participants in the NGF group reduced corticomotor map area and volume (p < 0.001), but the IS group did not show any significant corticomotor mapping changes after the injection (p > 0.050). Finally, there was a significant correlation between the magnitude of decreased corticomotor excitability and jaw pain intensity on chewing 48 hr after the NGF injection (r = -0.51, p = 0.009).
CONCLUSION


NGF-induced masseter muscle soreness can significantly reduce jaw muscle corticomotor excitability, which in turn is associated with lower jaw pain intensity and substantiates the occurrence of central changes that most likely aim to protect the musculoskeletal orofacial structures.
SIGNIFICANCE


Intramuscular administration of nerve growth factor into masseter muscle causes inhibitory corticomotor plasticity, which likely occurs to prevent further damage and seems associated with lower pain intensity on function.",2019,"Likewise, the participants in the NGF group reduced corticomotor map area and volume (p<0.001), but the IS group did not show any significant corticomotor mapping changes after the injection (p>0.050).",['healthy participants'],"['NGF-induced masseter muscle soreness', 'placebo', 'isotonic saline', 'NGF', 'motor-evoked potentials (MEPs', 'nerve growth factor (NGF) injection']","['jaw pain and increased jaw functional disability', 'MEP amplitude', 'right masseter MEP amplitude and corticomotor mapping and clinical assessment of jaw pain intensity and function', 'Masseter corticomotor excitability', 'corticomotor excitability and jaw pain intensity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0024876', 'cui_str': 'Masseter Muscle'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0236000', 'cui_str': 'Jaw pain (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}]",,0.209691,"Likewise, the participants in the NGF group reduced corticomotor map area and volume (p<0.001), but the IS group did not show any significant corticomotor mapping changes after the injection (p>0.050).","[{'ForeName': 'Yuri M', 'Initials': 'YM', 'LastName': 'Costa', 'Affiliation': 'Department of Physiological Sciences, Piracicaba Dental School, University of Campinas, Piracicaba, Brazil.'}, {'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Exposto', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Kothari', 'Affiliation': 'Scandinavian Center for Orofacial Neurosciences (SCON), Aarhus, Denmark.'}, {'ForeName': 'Eduardo E', 'Initials': 'EE', 'LastName': 'Castrillon', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Paulo César R', 'Initials': 'PCR', 'LastName': 'Conti', 'Affiliation': 'Department of Prosthodontics, Bauru School of Dentistry, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Leonardo R', 'Initials': 'LR', 'LastName': 'Bonjardim', 'Affiliation': 'Section of Head and Face Physiology, Department of Biological Sciences, Bauru School of Dentistry, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Svensson', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}]","European journal of pain (London, England)",['10.1002/ejp.1438']
1031,32410485,"Caffeinated Beverage Intake, Dyspnea With Ticagrelor, and Cardiovascular Outcomes: Insights From the PEGASUS-TIMI 54 Trial.","Background A proposed cause of dyspnea induced by ticagrelor is an increase in adenosine blood levels. Because caffeine is an adenosine antagonist, it can potentially improve drug tolerability with regard to dyspnea. Furthermore, association between caffeine and cardiovascular events is of clinical interest. Methods and Results This prespecified analysis used data from the PEGASUS TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54) trial, which randomized 21 162 patients with prior myocardial infarction to ticagrelor 60 mg or 90 mg or matching placebo (twice daily). Baseline caffeine intake in cups per week was prospectively collected for 9694 patients. Outcomes of interest included dyspnea, major adverse cardiovascular events (ie, the composite of cardiovascular death, myocardial infarction, or stroke), and arrhythmias. Dyspnea analyses considered the pooled ticagrelor group, whereas cardiovascular outcome analyses included patients from the 3 randomized arms. After adjustment, caffeine intake, compared with no intake, was not associated with lower rates of dyspnea in patients taking ticagrelor (adjusted hazard ratio (HR), 0.91; 95% CI, 0.76-1.10;  P =0.34). There was no excess risk with caffeine for major adverse cardiovascular events (adjusted HR, 0.78; 95% CI, 0.63-0.98;  P =0.031), sudden cardiac death (adjusted HR, 0.98; 95% CI, 0.57-1.70;  P =0.95), or atrial fibrillation (adjusted odds ratio, 1.07; 95% CI, 0.56-2.04;  P =0.84). Conclusions In patients taking ticagrelor for secondary prevention after myocardial infarction, caffeine intake at baseline was not associated with lower rates of dyspnea compared with no intake. Otherwise, caffeine appeared to be safe in this population, with no apparent increase in atherothrombotic events or clinically significant arrhythmias. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT01225562.",2020,"There was no excess risk with caffeine for major adverse cardiovascular events (adjusted HR, 0.78; 95% CI, 0.63-0.98;  P =0.031), sudden cardiac death (adjusted HR, 0.98; 95% CI, 0.57-1.70;  P =0.95), or atrial fibrillation (adjusted odds ratio, 1.07; 95% CI, 0.56-2.04;  P =0.84).","['9694 patients', 'Patients With Prior Heart Attack Using', '162 patients with prior myocardial infarction to']","['Ticagrelor', 'Placebo', 'Aspirin-Thrombolysis', 'caffeine', 'ticagrelor 60\xa0mg or 90\xa0mg or matching placebo', 'ticagrelor']","['dyspnea, major adverse cardiovascular events (ie, the composite of cardiovascular death, myocardial infarction, or stroke), and arrhythmias', 'Caffeinated Beverage Intake, Dyspnea With Ticagrelor, and Cardiovascular Outcomes', 'atrial fibrillation', 'major adverse cardiovascular events', 'rates of dyspnea', 'atherothrombotic events', 'sudden cardiac death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C5191360', 'cui_str': '162'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C4051377', 'cui_str': 'Ticagrelor 60 MG'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0085298', 'cui_str': 'Sudden cardiac death'}]",21162.0,0.16121,"There was no excess risk with caffeine for major adverse cardiovascular events (adjusted HR, 0.78; 95% CI, 0.63-0.98;  P =0.031), sudden cardiac death (adjusted HR, 0.98; 95% CI, 0.57-1.70;  P =0.95), or atrial fibrillation (adjusted odds ratio, 1.07; 95% CI, 0.56-2.04;  P =0.84).","[{'ForeName': 'Remo H M', 'Initials': 'RHM', 'LastName': 'Furtado', 'Affiliation': ""TIMI Study Group Brigham and Women's Hospital Harvard Medical School Boston MA.""}, {'ForeName': 'Ramkumar V', 'Initials': 'RV', 'LastName': 'Venkateswaran', 'Affiliation': ""TIMI Study Group Brigham and Women's Hospital Harvard Medical School Boston MA.""}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor) Hospital das Clinicas da Faculdade de Medicina Universidade de Sao Paulo Brazil.'}, {'ForeName': 'Yared', 'Initials': 'Y', 'LastName': 'Gurmu', 'Affiliation': ""TIMI Study Group Brigham and Women's Hospital Harvard Medical School Boston MA.""}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""TIMI Study Group Brigham and Women's Hospital Harvard Medical School Boston MA.""}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'University of Sheffield United Kingdom.'}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de Paris, and Assistance Publique-Hôpitaux de Paris Paris France.'}, {'ForeName': 'Giuglia', 'Initials': 'G', 'LastName': 'Magnani', 'Affiliation': 'University Hospital of Parma Italy.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Goto', 'Affiliation': 'Department of Medicine (Cardiology) Tokai University Hospital Isehara Japan.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Dellborg', 'Affiliation': 'Sahlgrenska Academy University of Gothenburg Sweden.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Kamensky', 'Affiliation': 'Department of Non-invasive Cardiovascular Diagnostics University Hospital Bratislava Bratislava Slovakia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Isaza', 'Affiliation': 'Fundacion Cardioinfantil Instituto de Cardiologia Bogotá Colombia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Aylward', 'Affiliation': 'South Australian Health and Medical Research Institute Flinders University and Medical Centre Adelaide Australia.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Johanson', 'Affiliation': 'AstraZeneca Mölndal Sweden.'}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': ""TIMI Study Group Brigham and Women's Hospital Harvard Medical School Boston MA.""}]",Journal of the American Heart Association,['10.1161/JAHA.119.015785']
1032,31178342,"Hartmann's procedure versus sigmoidectomy with primary anastomosis for perforated diverticulitis with purulent or faecal peritonitis (LADIES): a multicentre, parallel-group, randomised, open-label, superiority trial.","BACKGROUND


Previous studies have suggested that sigmoidectomy with primary anastomosis is superior to Hartmann's procedure. The likelihood of stoma reversal after primary anastomosis has been reported to be higher and reversal seems to be associated with lower morbidity and mortality. Although promising, results from these previous studies remain uncertain because of potential selection bias. Therefore, this study aimed to assess outcomes after Hartmann's procedure versus sigmoidectomy with primary anastomosis, with or without defunctioning ileostomy, for perforated diverticulitis with purulent or faecal peritonitis (Hinchey III or IV disease) in a randomised trial.
METHODS


A multicentre, randomised, open-label, superiority trial was done in eight academic hospitals and 34 teaching hospitals in Belgium, Italy, and the Netherlands. Patients aged between 18 and 85 years who presented with clinical signs of general peritonitis and suspected perforated diverticulitis were eligible for inclusion if plain abdominal radiography or CT scan showed diffuse free air or fluid. Patients with Hinchey I or II diverticulitis were not eligible for inclusion. Patients were allocated (1:1) to Hartmann's procedure or sigmoidectomy with primary anastomosis, with or without defunctioning ileostomy. Patients were enrolled by the surgeon or surgical resident involved, and secure online randomisation software was used in the operating room or by the trial coordinator on the phone. Random and concealed block sizes of two, four, or six were used, and randomisation was stratified by age (<60 and ≥60 years). The primary endpoint was 12-month stoma-free survival. Patients were analysed according to a modified intention-to-treat principle. The trial is registered with the Netherlands Trial Register, number NTR2037, and ClinicalTrials.gov, number NCT01317485.
FINDINGS


Between July 1, 2010, and Feb 22, 2013, and June 9, 2013, and trial termination on June 3, 2016, 133 patients (93 with Hinchey III disease and 40 with Hinchey IV disease) were randomly assigned to Hartmann's procedure (68 patients) or primary anastomosis (65 patients). Two patients in the Hartmann's group were excluded, as was one in the primary anastomosis group; the modified intention-to-treat population therefore consisted of 66 patients in the Hartmann's procedure group (46 with Hinchey III disease, 20 with Hinchey IV disease) and 64 in the primary anastomosis group (46 with Hinchey III disease, 18 with Hinchey IV disease). In 17 (27%) of 64 patients assigned to primary anastomosis, no stoma was constructed. 12-month stoma-free survival was significantly better for patients undergoing primary anastomosis compared with Hartmann's procedure (94·6% [95% CI 88·7-100] vs 71·7% [95% CI 60·1-83·3], hazard ratio 2·79 [95% CI 1·86-4·18]; log-rank p<0·0001). There were no significant differences in short-term morbidity and mortality after the index procedure for Hartmann's procedure compared with primary anastomosis (morbidity: 29 [44%] of 66 patients vs 25 [39%] of 64, p=0·60; mortality: two [3%] vs four [6%], p=0·44).
INTERPRETATION


In haemodynamically stable, immunocompetent patients younger than 85 years, primary anastomosis is preferable to Hartmann's procedure as a treatment for perforated diverticulitis (Hinchey III or Hinchey IV disease).
FUNDING


Netherlands Organisation for Health Research and Development.",2019,"12-month stoma-free survival was significantly better for patients undergoing primary anastomosis compared with Hartmann's procedure (94·6% [95% CI 88·7-100] vs 71·7% [95% CI 60·1-83·3], hazard ratio 2·79 [95% CI 1·86-4·18]; log-rank p<0·0001).","['Patients aged between 18 and 85 years who presented with clinical signs of general peritonitis and suspected perforated diverticulitis were eligible for inclusion if plain abdominal radiography or CT scan showed diffuse free air or fluid', 'Patients were enrolled by the surgeon or surgical resident involved, and secure online randomisation software was used in the operating room or by the trial coordinator on the phone', ""Two patients in the Hartmann's group were excluded, as was one in the primary anastomosis group; the modified intention-to-treat population therefore consisted of 66 patients in the Hartmann's procedure group (46 with Hinchey III disease, 20 with Hinchey IV disease) and 64 in the primary anastomosis group (46 with Hinchey III disease, 18 with Hinchey IV disease"", 'Patients with Hinchey I or II diverticulitis were not eligible for inclusion', '133 patients (93 with Hinchey III disease and 40 with Hinchey IV disease', 'Between July 1, 2010, and Feb 22, 2013, and June 9, 2013, and trial termination on June 3, 2016', 'eight academic hospitals and 34 teaching hospitals in Belgium, Italy, and the Netherlands']","[""Hartmann's procedure versus sigmoidectomy with primary anastomosis"", ""Hartmann's procedure versus sigmoidectomy with primary anastomosis, with or without defunctioning ileostomy, for perforated diverticulitis with purulent or faecal peritonitis (Hinchey III or IV disease"", ""Hartmann's procedure or sigmoidectomy with primary anastomosis, with or without defunctioning ileostomy"", ""Hartmann's procedure (68 patients) or primary anastomosis""]","['short-term morbidity and mortality', '12-month stoma-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0012813', 'cui_str': 'Diverticulitis'}, {'cui': 'C0034573', 'cui_str': 'Radiography, Abdominal'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0205219', 'cui_str': 'Diffuse (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0400084', 'cui_str': 'Hartmann operation, rectal resection (procedure)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C0400084', 'cui_str': 'Hartmann operation, rectal resection (procedure)'}, {'cui': 'C0192866', 'cui_str': 'Sigmoid colectomy (procedure)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0020883', 'cui_str': 'Ileostomy'}, {'cui': 'C0544794', 'cui_str': 'Perforated diverticulitis'}, {'cui': 'C0439665', 'cui_str': 'Purulent (morphologic abnormality)'}, {'cui': 'C0473119', 'cui_str': 'Fecal peritonitis (disorder)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1955856', 'cui_str': 'Surgical Stoma'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.188953,"12-month stoma-free survival was significantly better for patients undergoing primary anastomosis compared with Hartmann's procedure (94·6% [95% CI 88·7-100] vs 71·7% [95% CI 60·1-83·3], hazard ratio 2·79 [95% CI 1·86-4·18]; log-rank p<0·0001).","[{'ForeName': 'Daniël P V', 'Initials': 'DPV', 'LastName': 'Lambrichts', 'Affiliation': 'Department of Surgery, Erasmus University Medical Centre, Rotterdam, Netherlands; Department of Surgery, University Medical Centre Amsterdam, AMC, Amsterdam, Netherlands. Electronic address: d.lambrichts@erasmusmc.nl.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Vennix', 'Affiliation': 'Department of Radiology, University Medical Centre Amsterdam, VUmc, Amsterdam, Netherlands.'}, {'ForeName': 'Gijsbert D', 'Initials': 'GD', 'LastName': 'Musters', 'Affiliation': 'Department of Surgery, University Medical Centre Amsterdam, AMC, Amsterdam, Netherlands.'}, {'ForeName': 'Irene M', 'Initials': 'IM', 'LastName': 'Mulder', 'Affiliation': 'Department of Surgery, Rode Kruis Hospital, Beverwijk, Netherlands.'}, {'ForeName': 'Hilko A', 'Initials': 'HA', 'LastName': 'Swank', 'Affiliation': 'Department of Surgery, University Medical Centre Amsterdam, AMC, Amsterdam, Netherlands.'}, {'ForeName': 'Anton G M', 'Initials': 'AGM', 'LastName': 'Hoofwijk', 'Affiliation': 'Department of Surgery, Zuyderland Medical Centre, Sittard-Geleen, Netherlands.'}, {'ForeName': 'Eric H J', 'Initials': 'EHJ', 'LastName': 'Belgers', 'Affiliation': 'Department of Surgery, Zuyderland Medical Centre, Sittard-Geleen, Netherlands.'}, {'ForeName': 'Hein B A C', 'Initials': 'HBAC', 'LastName': 'Stockmann', 'Affiliation': 'Department of Surgery, Spaarne Gasthuis, Haarlem, Netherlands.'}, {'ForeName': 'Quirijn A J', 'Initials': 'QAJ', 'LastName': 'Eijsbouts', 'Affiliation': 'Department of Surgery, Spaarne Gasthuis, Haarlem, Netherlands.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Gerhards', 'Affiliation': 'Department of Surgery, OLVG, Amsterdam, Netherlands.'}, {'ForeName': 'Bart A', 'Initials': 'BA', 'LastName': 'van Wagensveld', 'Affiliation': 'Department of Surgery, OLVG, Amsterdam, Netherlands.'}, {'ForeName': 'Anna A W', 'Initials': 'AAW', 'LastName': 'van Geloven', 'Affiliation': 'Department of Surgery, Tergooi Hospital, Hilversum, Netherlands.'}, {'ForeName': 'Rogier M P H', 'Initials': 'RMPH', 'LastName': 'Crolla', 'Affiliation': 'Department of Surgery, Amphia Hospital, Breda, Netherlands.'}, {'ForeName': 'Simon W', 'Initials': 'SW', 'LastName': 'Nienhuijs', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, Netherlands.'}, {'ForeName': 'Marc J P M', 'Initials': 'MJPM', 'LastName': 'Govaert', 'Affiliation': 'Department of Surgery, Dijklander Hospital, Hoorn, Netherlands.'}, {'ForeName': 'Salomone', 'Initials': 'S', 'LastName': 'di Saverio', 'Affiliation': ""Department of Surgery, Maggiore Hospital, Bologna, Italy; Cambridge Colorectal Unit, Addenbrooke's Hospital, Cambridge University Hospitals NHS Trust, Cambridge, UK.""}, {'ForeName': 'André J L', 'Initials': 'AJL', 'LastName': ""D'Hoore"", 'Affiliation': 'Department of Abdominal Surgery, University Hospitals, Leuven, Belgium.'}, {'ForeName': 'Esther C J', 'Initials': 'ECJ', 'LastName': 'Consten', 'Affiliation': 'Department of Surgery, Meander Medical Centre, Amersfoort, Netherlands.'}, {'ForeName': 'Wilhelmina M U', 'Initials': 'WMU', 'LastName': 'van Grevenstein', 'Affiliation': 'Department of Surgery, University Medical Centre Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Robert E G J M', 'Initials': 'REGJM', 'LastName': 'Pierik', 'Affiliation': 'Department of Surgery, Isala Hospital, Zwolle, Netherlands.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Kruyt', 'Affiliation': 'Department of Surgery, Gelderse Vallei Hospital, Ede, Netherlands.'}, {'ForeName': 'Joost A B', 'Initials': 'JAB', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Surgery, Albert Schweitzer Hospital, Dordrecht, Netherlands.'}, {'ForeName': 'Willem H', 'Initials': 'WH', 'LastName': 'Steup', 'Affiliation': 'Department of Surgery, Haga Hospital, Den Haag, Netherlands.'}, {'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Catena', 'Affiliation': 'Department of Surgery, Maggiore Hospital, Parma, Italy.'}, {'ForeName': 'Joop L M', 'Initials': 'JLM', 'LastName': 'Konsten', 'Affiliation': 'Department of Surgery, VieCuri, Venlo, Netherlands.'}, {'ForeName': 'Jefrey', 'Initials': 'J', 'LastName': 'Vermeulen', 'Affiliation': 'Department of Surgery, Maasstad Hospital, Rotterdam, Netherlands.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'van Dieren', 'Affiliation': 'Department of Surgery, University Medical Centre Amsterdam, AMC, Amsterdam, Netherlands.'}, {'ForeName': 'Willem A', 'Initials': 'WA', 'LastName': 'Bemelman', 'Affiliation': 'Department of Surgery, University Medical Centre Amsterdam, AMC, Amsterdam, Netherlands.'}, {'ForeName': 'Johan F', 'Initials': 'JF', 'LastName': 'Lange', 'Affiliation': 'Department of Surgery, Erasmus University Medical Centre, Rotterdam, Netherlands; Department of Surgery, IJsselland Hospital, Capelle aan den IJssel, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30174-8']
1033,31575021,Baseline Serum Vitamin A and D Levels Determine Benefit of Oral Vitamin A&D Supplements to Humoral Immune Responses Following Pediatric Influenza Vaccination.,"Maximizing vaccine efficacy is critical, but previous research has failed to provide a one-size-fits-all solution. Although vitamin A and vitamin D supplementation studies have been designed to improve vaccine efficacy, experimental results have been inconclusive. Information is urgently needed to explain study discrepancies and to provide guidance for the future use of vitamin supplements at the time of vaccination. We conducted a randomized, blinded, placebo-controlled study of influenza virus vaccination and vitamin supplementation among 2 to 8 (inclusive) year old children over three seasons, including 2015-2016 ( n  = 9), 2016-2017 ( n  = 44), and 2017-2018 ( n  = 26). Baseline measurements of vitamins A and D were obtained from all participants. Measurements were of serum retinol, retinol-binding protein (RBP, a surrogate for retinol), and 25-hydroxyvitamin D (25(OH)D). Participants were stratified into two groups based on high and low incoming levels of RBP. Children received two doses of the seasonal influenza virus vaccine on days 0 and 28, either with an oral vitamin supplement (termed A&D; 20,000 IU retinyl palmitate and 2000 IU cholecalciferol) or a matched placebo. Hemagglutination inhibition (HAI) antibody responses were evaluated toward all four components of the influenza virus vaccines on days 0, 28, and 56. Our primary data were from season 2016-2017, as enrollment was highest in this season and all children exhibited homogeneous and negative HAI responses toward the Phuket vaccine at study entry. Responses among children who entered the study with insufficient or deficient levels of RBP and 25(OH)D benefited from the A&D supplement ( p  < 0.001 for the day 28 Phuket response), whereas responses among children with replete levels of RBP and 25(OH)D at baseline were unaffected or weakened ( p  = 0.02 for the day 28 Phuket response). High baseline RBP levels associated with high HAI titers, particularly for children in the placebo group (baseline RBP correlated positively with Phuket HAI titers on day 28,  r  = 0.6,  p  = 0.003). In contrast, high baseline 25(OH)D levels associated with weak HAI titers, particularly for children in the A&D group (baseline 25(OH)D correlated negatively with Phuket HAI titers on day 28,  r  = -0.5,  p  = 0.02). Overall, our study demonstrates that vitamin A&D supplementation can improve immune responses to vaccines when children are vitamin A and D-insufficient at baseline. Results provide guidance for the appropriate use of vitamins A and D in future clinical vaccine studies.",2019,"High baseline RBP levels associated with high HAI titers, particularly for children in the placebo group (baseline RBP correlated positively with Phuket HAI titers on day 28,  r  = 0.6,  p  = 0.003).","['2 to 8 (inclusive) year old children over three seasons, including 2015-2016 ( n  = 9), 2016-2017 ( n  = 44), and 2017-2018 ( n  = 26', 'Pediatric Influenza Vaccination']","['Oral Vitamin A&D Supplements', 'vitamin A and vitamin D supplementation', 'oral vitamin supplement (termed A&D; 20,000 IU retinyl palmitate and 2000 IU cholecalciferol', 'seasonal influenza virus vaccine', 'placebo', 'influenza virus vaccination and vitamin supplementation', 'vitamin A&D supplementation']","['vaccine efficacy', 'serum retinol, retinol-binding protein (RBP, a surrogate for retinol), and 25-hydroxyvitamin D (25(OH)D', 'High baseline RBP levels', 'Hemagglutination inhibition (HAI) antibody responses', 'HAI titers', 'Phuket HAI titers', 'negative HAI responses']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0681579', 'cui_str': 'Vitamin supplement'}, {'cui': 'C0073115', 'cui_str': 'retinyl palmitate'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course (qualifier value)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4316910', 'cui_str': 'Influenzavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1533658', 'cui_str': 'Vitamin supplement therapy'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0087161', 'cui_str': 'All-Trans-Retinol'}, {'cui': 'C1446172', 'cui_str': 'Retinol binding protein measurement (procedure)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",,0.313418,"High baseline RBP levels associated with high HAI titers, particularly for children in the placebo group (baseline RBP correlated positively with Phuket HAI titers on day 28,  r  = 0.6,  p  = 0.003).","[{'ForeName': 'Nehali', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. nehali.patel@stjude.org.""}, {'ForeName': 'Rhiannon R', 'Initials': 'RR', 'LastName': 'Penkert', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. rhiannon.penkert@stjude.org.""}, {'ForeName': 'Bart G', 'Initials': 'BG', 'LastName': 'Jones', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. bart.jones@stjude.org.""}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Sealy', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. bob.sealy@stjude.org.""}, {'ForeName': 'Sherri L', 'Initials': 'SL', 'LastName': 'Surman', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. sherri.surman@stjude.org.""}, {'ForeName': 'Yilun', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. yilun.sun@stjude.org.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. li.tang@stjude.org.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'DeBeauchamp', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. jennifer.deBeauchamp@stjude.org.""}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Webb', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. ashley.webb@stjude.org.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Richardson', 'Affiliation': ""Department of Pharmaceuticals, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. julie.richardson@stjude.org.""}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Heine', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. ryan.heine@stjude.org.""}, {'ForeName': 'Ronald H', 'Initials': 'RH', 'LastName': 'Dallas', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. ronald.dallas@stjude.org.""}, {'ForeName': 'A Catharine', 'Initials': 'AC', 'LastName': 'Ross', 'Affiliation': 'Department of Nutritional Sciences, Pennsylvania State University, University Park, PA 16802, USA. acr6@psu.edu.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Webby', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. richard.webby@stjude.org.""}, {'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Hurwitz', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. julia.hurwitz@stjude.org.""}]",Viruses,['10.3390/v11100907']
1034,30945740,Sleep Apnea Multilevel Surgery (SAMS) trial protocol: a multicenter randomized clinical trial of upper airway surgery for patients with obstructive sleep apnea who have failed continuous positive airway pressure.,"STUDY OBJECTIVES


Obstructive sleep apnea (OSA) is a serious and costly public health problem. The main medical treatment, continuous positive airway pressure, is efficacious when used, but poorly tolerated in up to 50% of patients. Upper airway reconstructive surgery is available when medical treatments fail but randomized trial evidence supporting its use is limited. This protocol details a randomized controlled trial designed to assess the clinical effectiveness, safety, and cost-effectiveness of a multilevel upper airway surgical procedure for OSA.
METHODS


A prospective, parallel-group, open label, randomized, controlled, multicenter clinical trial in adults with moderate or severe OSA who have failed or refused medical therapies. Six clinical sites in Australia randomly allocated participants in a 1:1 ratio to receive either an upper airway surgical procedure consisting of a modified uvulopalatopharyngoplasty and minimally invasive tongue volume reduction, or to continue with ongoing medical management, and followed them for 6 months.
RESULTS


Primary outcomes: difference between groups in baseline-adjusted 6 month OSA severity (apnea-hypopnea index) and subjective sleepiness (Epworth Sleepiness Scale). Secondary outcomes: other OSA symptoms (e.g. snoring and objective sleepiness), other polysomnography parameters (e.g. arousal index and 4% oxygen desaturation index), quality of life, 24 hr ambulatory blood pressure, adverse events, and adherence to ongoing medical therapies (medical group).
CONCLUSIONS


The Sleep Apnea Multilevel Surgery (SAMS) trial is of global public health importance for testing the effectiveness and safety of a multilevel surgical procedure for patients with OSA who have failed medical treatment.
CLINICAL TRIAL REGISTRATION


Multilevel airway surgery in patients with moderate-severe Obstructive Sleep Apnea (OSA) who have failed medical management to assess change in OSA events and daytime sleepiness. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366019&isReview=true Australian New Zealand Clinical Trials Registry ACTRN12614000338662, prospectively registered on 31 March 2014.",2019,"The main medical treatment, continuous positive airway pressure, is efficacious when used, but poorly tolerated in up to 50% of patients.","['patients with moderate-severe Obstructive Sleep Apnea (OSA', 'patients with obstructive sleep apnea who have failed continuous positive airway pressure', 'adults with moderate or severe OSA who have failed or refused medical therapies', 'Obstructive sleep apnea (OSA', 'patients with OSA who have failed medical treatment']","['Upper airway reconstructive surgery', 'upper airway surgery', 'Sleep Apnea Multilevel Surgery (SAMS', 'upper airway surgical procedure consisting of a modified uvulopalatopharyngoplasty and minimally invasive tongue volume reduction, or to continue with ongoing medical management, and followed them for 6 months', 'Multilevel airway surgery', 'multilevel upper airway surgical procedure']","['clinical effectiveness, safety, and cost-effectiveness', 'OSA symptoms (e.g. snoring and objective sleepiness), other polysomnography parameters (e.g. arousal index and 4% oxygen desaturation index), quality of life, 24 hr ambulatory blood pressure, adverse events, and adherence to ongoing medical therapies (medical group', 'baseline-adjusted 6 month OSA severity (apnea-hypopnea index) and subjective sleepiness (Epworth Sleepiness Scale', 'OSA events and daytime sleepiness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1535578', 'cui_str': 'Uvulopalatopharyngoplasty (procedure)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037384', 'cui_str': 'Snorings'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0034380'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}]",,0.0881314,"The main medical treatment, continuous positive airway pressure, is efficacious when used, but poorly tolerated in up to 50% of patients.","[{'ForeName': 'A Simon', 'Initials': 'AS', 'LastName': 'Carney', 'Affiliation': 'Department of Surgery, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Antic', 'Affiliation': 'Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Catcheside', 'Affiliation': 'Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.'}, {'ForeName': 'Ching', 'Initials': 'C', 'LastName': 'Li Chai-Coetzer', 'Affiliation': 'Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Cistulli', 'Affiliation': 'Department of Respiratory Medicine and Sleep, Royal North Shore Hospital, St Leonards, NSW, Australia.'}, {'ForeName': 'Billingsley', 'Initials': 'B', 'LastName': 'Kaambwa', 'Affiliation': 'Health Economics Unit, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.'}, {'ForeName': 'Stuart G', 'Initials': 'SG', 'LastName': 'MacKay', 'Affiliation': 'Illawarra ENT Head and Neck Clinic, Wollongong, NSW, Australia.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Pinczel', 'Affiliation': 'Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Weaver', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, University of Washington, Staff Surgeon, Seattle Veterans Affairs Medical Center, Seattle, WA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Woodman', 'Affiliation': 'Flinders Centre for Epidemiology and Biostatistics, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.'}, {'ForeName': 'Charmaine M', 'Initials': 'CM', 'LastName': 'Woods', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Southern Adelaide Local Health Network, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.'}, {'ForeName': 'R Doug', 'Initials': 'RD', 'LastName': 'McEvoy', 'Affiliation': 'Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.'}]",Sleep,['10.1093/sleep/zsz056']
1035,31106666,Predictive value of serum amyloid a levels for requirement of concomitant methotrexate in tocilizumab initiation: A  post hoc  analysis of the SURPRISE study.,"Objectives:  To identify predictive factors for remission by tocilizumab monotherapy in rheumatoid arthritis (RA) patients. Methods:  This is a  post hoc  analysis of the SURPRISE study, a 2-year randomized, controlled study comparing the efficacy of tocilizumab with (ADD-ON) and without methotrexate (SWITCH). The primary endpoint was DAS28-ESR remission (<2.6) at week 24. The change in modified total Sharp score from baseline to week 52 (ΔmTSS/year) was also assessed as an endpoint. The effect of clinical parameters at baseline on remission was estimated by logistic regression analysis. Results:  In SWITCH ( n  = 96), CRP, SAA, RF, and DAS28 at baseline showed predictive value for DAS28 remission in unadjusted analysis. Adjusted analysis confirmed SAA and DAS28 as predictive factors, with SAA having the highest value (ROC-AUC = 0.731). Furthermore, structural remission (ΔmTSS/year ≤ 0.5) rate was significantly higher in patients with SAA of < 50.0 μg/mL than other patients. In contrast, in ADD-ON ( n  = 98), only DAS28 showed predictive value for DAS28 remission. In patients with SAA < 50.0 μg/mL, both DAS28 remission and structural remission rate were comparable between SWITCH and ADD-ON. Conclusion:  RA patients with low SAA levels at baseline may benefit similarly from tocilizumab with and without methotrexate. Trial registration number:  NCT01120366.",2020,"Furthermore, structural remission (ΔmTSS/year ≤ 0.5) rate was significantly higher in patients with SAA of < 50.0 μg/mL than other patients.",['rheumatoid arthritis (RA) patients'],"['tocilizumab', 'tocilizumab with (ADD-ON) and without methotrexate (SWITCH', 'tocilizumab monotherapy']","['structural remission (ΔmTSS/year ≤\u20090.5) rate', 'low SAA levels', 'DAS28-ESR remission', 'DAS28 remission and structural remission rate']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.372353,"Furthermore, structural remission (ΔmTSS/year ≤ 0.5) rate was significantly higher in patients with SAA of < 50.0 μg/mL than other patients.","[{'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Kaneko', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Inoo', 'Affiliation': 'Department of Internal Medicine, Utazu Hospital, Ehime, Japan.'}, {'ForeName': 'Hitomi', 'Initials': 'H', 'LastName': 'Kobayashi-Haraoka', 'Affiliation': 'Division of Hematology and Rheumatology, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Amano', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Miyata', 'Affiliation': 'Department of Internal Medicine, Fukushima Red Cross Hospital, Fukushima, Japan.'}, {'ForeName': 'Yohko', 'Initials': 'Y', 'LastName': 'Murakawa', 'Affiliation': 'Department of Rheumatology, Shimane University Faculty of Medicine, Izumo, Japan.'}, {'ForeName': 'Hidekata', 'Initials': 'H', 'LastName': 'Yasuoka', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Hirata', 'Affiliation': 'Department of Clinical Immunology and Rheumatology, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Hayato', 'Initials': 'H', 'LastName': 'Nagasawa', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Tanaka', 'Affiliation': ""Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Miyasaka', 'Affiliation': 'Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Yamanaka', 'Affiliation': ""Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Allergy and Rheumatology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Yokota', 'Affiliation': 'Department of Biostatistics, Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}]",Modern rheumatology,['10.1080/14397595.2019.1621026']
1036,32410578,Application of the matched nested case-control design to the secondary analysis of trial data.,"BACKGROUND


A nested case-control study is an efficient design that can be embedded within an existing cohort study or randomised trial. It has a number of advantages compared to the conventional case-control design, and has the potential to answer important research questions using untapped prospectively collected data.
METHODS


We demonstrate the utility of the matched nested case-control design by applying it to a secondary analysis of the Abnormal Doppler Enteral Prescription Trial. We investigated the role of milk feed type and changes in milk feed type in the development of necrotising enterocolitis in a group of 398 high risk growth-restricted preterm infants.
RESULTS


Using matching, we were able to generate a comparable sample of controls selected from the same population as the cases. In contrast to the standard case-control design, exposure status was ascertained prior to the outcome event occurring and the comparison between the cases and matched controls could be made at the point at which the event occurred. This enabled us to reliably investigate the temporal relationship between feed type and necrotising enterocolitis.
CONCLUSIONS


A matched nested case-control study can be used to identify credible associations in a secondary analysis of clinical trial data where the exposure of interest was not randomised, and has several advantages over a standard case-control design. This method offers the potential to make reliable inferences in scenarios where it would be unethical or impractical to perform a randomised clinical trial.",2020,"It has a number of advantages compared to the conventional case-control design, and has the potential to answer important research questions using untapped prospectively collected data.
",['necrotising enterocolitis in a group of 398 high risk growth-restricted preterm infants'],[],[],"[{'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]",[],[],,0.039978,"It has a number of advantages compared to the conventional case-control design, and has the potential to answer important research questions using untapped prospectively collected data.
","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Partlett', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK. chris.partlett@nottingham.ac.uk.'}, {'ForeName': 'Nigel J', 'Initials': 'NJ', 'LastName': 'Hall', 'Affiliation': 'University Surgery Unit, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Leaf', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Juszczak', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Linsell', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}]",BMC medical research methodology,['10.1186/s12874-020-01007-w']
1037,32410495,Intervention Adherence and Self-Efficacy as Predictors of Child Outcomes in School Nurse-Delivered Interventions for Anxiety.,"This study examined the association between two implementation factors, nurse-reported intervention adherence and self-efficacy, and children's outcomes in school nurse-delivered anxiety interventions. Data were collected in a pilot randomized controlled effectiveness trial with 54 children and 21 school nurses. Nurses implemented either a cognitive behavioral or relaxation-skills-only intervention. Nurse questionnaires assessed implementation factors. Independent evaluators assessed changes in children's anxiety symptoms at postintervention and at 3-month follow-up using clinical improvement and global functioning scales. Regression analyses indicated that greater intervention adherence was associated with greater anxiety symptom improvement at follow-up. Nurse self-efficacy interacted with intervention group, such that nurses with higher self-efficacy who implemented the cognitive behavioral intervention tended to have children show improvement and higher postintervention functioning. The impact of implementation factors on children's outcomes may differ depending on intervention type. Self-efficacy may be important for nurses using relatively complex interventions. Intervention adherence should be supported through training and consultation.",2020,"Nurse self-efficacy interacted with intervention group, such that nurses with higher self-efficacy who implemented the cognitive behavioral intervention tended to have children show improvement and higher postintervention functioning.","['54 children and 21 school nurses', 'School Nurse-Delivered Interventions for Anxiety']","['school nurse-delivered anxiety interventions', 'cognitive behavioral or relaxation-skills-only intervention', 'cognitive behavioral intervention']","[""children's anxiety symptoms"", 'anxiety symptom improvement', 'Self-efficacy']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0302833', 'cui_str': 'School nurse'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0302833', 'cui_str': 'School nurse'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",54.0,0.0180323,"Nurse self-efficacy interacted with intervention group, such that nurses with higher self-efficacy who implemented the cognitive behavioral intervention tended to have children show improvement and higher postintervention functioning.","[{'ForeName': 'E B', 'Initials': 'EB', 'LastName': 'Caron', 'Affiliation': 'Department of Psychological Science, Fitchburg State University, MA, USA.'}, {'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Drake', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Stewart', 'Affiliation': 'Department of Psychological Sciences, University of Connecticut, Storrs, CT, USA.'}, {'ForeName': 'Michela A', 'Initials': 'MA', 'LastName': 'Muggeo', 'Affiliation': 'Clarus Health Alliance, Norwich, CT, USA.'}, {'ForeName': 'Golda S', 'Initials': 'GS', 'LastName': 'Ginsburg', 'Affiliation': 'Department of Psychiatry, University of Connecticut School of Medicine, West Hartford, CT, USA.'}]",The Journal of school nursing : the official publication of the National Association of School Nurses,['10.1177/1059840520925522']
1038,32410519,Comparison and Evaluation of Three Techniques for Treating Auricular Pseudocyst.,"BACKGROUND


Auricular pseudocyst is a benign cystic lesion in cartilages of the auricle. Different methods are currently used to manage this disease. In these methods, simple aspiration combined with pressure dressing, local steroid injection and surgery are the most prevalent therapies.
OBJECTIVE


To find the best clinical path for the treatment of auricular pseudocyst.
METHODS


Eighty-four subjects were randomly allocated into three equal groups (Group A: simple suction combined with pressure dressing; Group B: suction and local steroid injection; and, Group C: surgery). Two otolaryngologists assessed effective rate, sequelae and degree of satisfaction at three-month follow-up. A visual analog scale was used to determine degree of satisfaction.
RESULTS


Group A had the lowest effective rate (54%). Group C was highest in terms of effectiveness (100%) but also in incidence of sequelae (71%). Group B had a slightly lower effective rate (86%) than Group C, but the incidence of sequelae was lowest (42%). Degree of satisfaction was highest (7.0 ± 2.7) for Group B.
CONCLUSION


Local steroid injection should be the first choice for the treatment of auricular pseudocyst because of high satisfaction, favorable effectiveness and few sequelae. Where this method is ineffective, surgery should be used.",2020,"Group B had a slightly lower effective rate (86%) than Group C, but the incidence of sequelae was lowest (42%).",['Eighty-four subjects'],"['simple suction combined with pressure dressing; Group B: suction and local steroid injection', 'Local steroid injection']","['Degree of satisfaction', 'incidence of sequelae', 'lowest effective rate', 'effective rate, sequelae and degree of satisfaction', 'effective rate']","[{'cui': 'C4319623', 'cui_str': '84'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1289828', 'cui_str': 'Pressure dressing'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0243088', 'cui_str': 'sequels'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",84.0,0.0604002,"Group B had a slightly lower effective rate (86%) than Group C, but the incidence of sequelae was lowest (42%).","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Otolaryngology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, 250021, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Shandong University of Tradition Chinese Medicine, Jinan, Shandong, 250014, China.'}, {'ForeName': 'Qianru', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Department of Otolaryngology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, 250021, China.'}, {'ForeName': 'Benling', 'Initials': 'B', 'LastName': 'Guan', 'Affiliation': 'Shandong University of Tradition Chinese Medicine, Jinan, Shandong, 250014, China.'}, {'ForeName': 'Chengfang', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Otolaryngology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, 250021, China.'}, {'ForeName': 'Shudong', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Otolaryngology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, 250021, China.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1770169']
1039,29631457,"Effects of Kinesio taping in  rectus femoris  activity and sit-to-stand movement in children with unilateral cerebral palsy: placebo-controlled, repeated-measure design.","Background:  Although it has been commonly used in rehabilitation sets, there is a lack of studies verifying the effects of Kinesio taping to improve functionality in children with Cerebral Palsy (CP). This information would promote evidence-based practice.  Purpose:  To verify the effects of Kinesio taping in the performance of sit-to-stand movement in children with unilateral CP.  Methods and materials:  A blinded, single placebo-controlled and repeated-measure design. The setting was the rehabilitation clinic of the university and care facilities. A total of 11 children from 6 to 12 years of age (mean: 10.5 years; standard deviation: 2.8 years) and classified as levels I and II by the Gross Motor Function Classification System were included. Kinesio taping was applied over the  rectus femoris  of the affected limb. Three taping conditions were used: Kinesio taping, without Kinesio taping and placebo. Three seat heights were used: neutral (100%), lowered (80%), and elevated (120%). Muscle activity (electromyography) and trunk and lower limb alignment (kinematics) were evaluated as body structures and function measures. The time required to perform sit-to-stand was used as a functionality measure. Mixed analysis of variation (ANOVA) measured angular variables of the hip, knee, ankle, and  rectus femoris  activity. Repeated ANOVA measured angular variables of trunk and pelvis and total duration. Significance was accepted for values of  p  ≤ 0.05.  Results:  Kinesio taping increased  rectus femoris  activity, decreased peak flexion of the trunk, knee, hip, and ankle, and increased trunk extension in the end of sit-to-stand when compared with without Kinesio taping and placebo. Total duration was decreased with lower effect sizes.  Conclusions:  Immediate application of Kinesio taping modified body structures and function measures during sit-to-stand in children with unilateral CP, but it did not alter functionality. Implications for Rehabilitation Evidence-based practice about the use of Kinesio taping in Cerebral Palsy. Knowledge about alternative rehabilitation techniques in Cerebral Palsy. Knowledge about sensory stimulation in Cerebral Palsy. Effectiveness of Kinesio taping in muscle activation.",2019,"Results:  Kinesio taping increased  rectus femoris  activity, decreased peak flexion of the trunk, knee, hip, and ankle, and increased trunk extension in the end of sit-to-stand when compared with without Kinesio taping and placebo.","['11 children from 6 to 12\xa0years of age (mean: 10.5\xa0years; standard deviation: 2.8\xa0years) and classified as levels', 'children with Cerebral Palsy (CP', 'Cerebral Palsy', 'children with unilateral cerebral palsy', 'children with unilateral CP']","['Kinesio taping modified body structures', 'Kinesio taping, without Kinesio taping and placebo', 'placebo', 'Kinesio taping']","['hip, knee, ankle, and  rectus femoris  activity', 'rectus femoris  activity, decreased peak flexion of the trunk, knee, hip, and ankle, and increased trunk extension', 'Total duration', 'Muscle activity (electromyography) and trunk and lower limb alignment (kinematics']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1268086', 'cui_str': 'Body structure'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0584894', 'cui_str': 'Rectus Femoris'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}]",11.0,0.027882,"Results:  Kinesio taping increased  rectus femoris  activity, decreased peak flexion of the trunk, knee, hip, and ankle, and increased trunk extension in the end of sit-to-stand when compared with without Kinesio taping and placebo.","[{'ForeName': 'Adriana Neves', 'Initials': 'AN', 'LastName': 'Dos Santos', 'Affiliation': 'a Department of Physiotherapy , Universidade Federal de São Carlos , São Carlos , Brazil.'}, {'ForeName': 'Livia Pessarelli', 'Initials': 'LP', 'LastName': 'Visicatto', 'Affiliation': 'a Department of Physiotherapy , Universidade Federal de São Carlos , São Carlos , Brazil.'}, {'ForeName': 'Ana Beatriz', 'Initials': 'AB', 'LastName': 'de Oliveira', 'Affiliation': 'a Department of Physiotherapy , Universidade Federal de São Carlos , São Carlos , Brazil.'}, {'ForeName': 'Nelci Adriana Cicuto Ferreira', 'Initials': 'NACF', 'LastName': 'Rocha', 'Affiliation': 'a Department of Physiotherapy , Universidade Federal de São Carlos , São Carlos , Brazil.'}]",Disability and rehabilitation,['10.1080/09638288.2018.1458912']
1040,31053213,Effects of Two-Week Sleep Extension on Glucose Metabolism in Chronically Sleep-Deprived Individuals.,"STUDY OBJECTIVES


Sleep deprivation is known to be associated with insulin resistance and diabetes risk. This study investigated whether 2-week sleep extension in chronically sleep-deprived individuals would improve glucose metabolism.
METHODS


A crossover study was conducted in volunteers without diabetes who reported sleeping ≤ 6 h/night. They were randomized to maintain their habitual sleep or extend sleep time for 2 weeks, then crossed over after a washout period. Sleep was monitored by actigraphy. Oral glucose tolerance tests (75 g) with insulin levels was performed at the end of each period. Mixed-effect linear regression analysis, adjusting for sequence and period effects, was applied.
RESULTS


A total of 21 participants (19 females) with mean (standard deviation) age of 33.1 (6.1) years completed the protocol. Mean sleep duration during habitual sleep was 318.7 (44.3) minutes and the participants extended their sleep by 36.0 (45.2) minutes during sleep extension. The average washout period was 21 (11) days. There were no significant effects of sleep extension on any metabolic parameters. The per-protocol analysis included eight participants who could sleep more than 6 hours during sleep extension (mean sleep duration 396 [25] minutes, extended by 60.1 [28.5] minutes). Among these individuals, sleep extension improved Homeostatic Model Assessment of Insulin Resistance (adjusted mean difference -0.50 [95% confidence interval [CI] -0.89, -0.11,  P  = .013]), early insulin secretion (insulinogenic index; mean difference 0.39 [95% CI 0.15, 0.63,  P  = .001]), and β-cell function (disposition index, mean difference 1.07 [95% CI 0.17, 1.97,  P  = .02]).
CONCLUSIONS


Sleep extension in chronically sleep-deprived individuals improved glucose metabolism in only those who could objectively extend their sleep to more than 6 h/night. Our findings suggest that a critical amount of sleep is needed to benefit metabolic outcomes.",2019,"Among these individuals, sleep extension improved Homeostatic Model Assessment of Insulin Resistance (adjusted mean difference","['volunteers without diabetes who reported sleeping ≤ 6 h/night', 'Chronically Sleep-Deprived Individuals', 'eight participants who could sleep more than 6 hours during sleep extension (mean sleep duration 396 [25] minutes, extended by 60.1 [28.5] minutes', '21 participants (19 females) with mean (standard deviation) age of 33.1 (6.1) years completed the protocol', 'chronically sleep-deprived individuals']",['Two-Week Sleep Extension'],"['early insulin secretion (insulinogenic index', 'Sleep', 'Glucose Metabolism', 'Oral glucose tolerance tests', 'glucose metabolism', 'β-cell function (disposition index', 'Homeostatic Model Assessment of Insulin Resistance', 'Mean sleep duration during habitual sleep']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0587116', 'cui_str': 'During sleep (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0743223', 'cui_str': 'Disposition (disposition)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}]",8.0,0.0585718,"Among these individuals, sleep extension improved Homeostatic Model Assessment of Insulin Resistance (adjusted mean difference","[{'ForeName': 'Apichart', 'Initials': 'A', 'LastName': 'So-Ngern', 'Affiliation': 'Division of Sleep Medicine, Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Naricha', 'Initials': 'N', 'LastName': 'Chirakalwasan', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Sunee', 'Initials': 'S', 'LastName': 'Saetung', 'Affiliation': 'Division of Endocrinology and Metabolism, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Suwannee', 'Initials': 'S', 'LastName': 'Chanprasertyothin', 'Affiliation': 'Research Center, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Ammarin', 'Initials': 'A', 'LastName': 'Thakkinstian', 'Affiliation': 'Section for Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sirimon', 'Initials': 'S', 'LastName': 'Reutrakul', 'Affiliation': 'Division of Endocrinology and Metabolism, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7758']
1041,31182181,Does food insulin index in the context of mixed meals affect postprandial metabolic responses and appetite in obese adolescents with insulin resistance? A randomised cross-over trial.,"The food insulin index (II) is a novel classification to rank foods based on their physiological insulin demand relative to an isoenergetic reference food and may be a valid predictor of postprandial insulin responses and appetite. The present study aimed to compare the postprandial metabolic responses and appetite sensations to two macronutrient- and glycaemic index-matched meals with either high or low II in obese adolescents with insulin resistance (IR). A randomised, single-blind and cross-over trial included fifteen obese adolescents aged 12-18 years with IR. All participants were provided with two different breakfasts: low glycaemic index, low insulin index (LGI-LII) and low glycaemic index, high insulin index (LGI-HII), with a 1-week washout period between meals. At time 0 (just before breakfast), 15, 30, 45, 60, 90, 120, 180 and 240 min after the meal, serum glucose, insulin and C-peptide levels and appetite scores were measured. At the end of 4 h, participants were served ad libitum lunch. Early (0-30 min), late (45-240 min) and total (0-240 min) postprandial insulin responses were lowered by 56·1, 34·6 and 35·6 % after the LGI-LII meal v. LGI-HII meal (P < 0·05). The feeling of hunger was also decreased by 25·8 and 27·5 % after the LGI-LII meal v. LGI-HII meal during the late and total responses (P < 0·05). The calculation II of meals or diets may be a useful dietary approach to reduce postprandial hyperinsulinaemia and the perceived hunger in obese adolescents with IR.",2019,The feeling of hunger was also decreased by 25.8% and 27.5% after LGI-LII meal vs. LGI-HII meal during the late and total responses (p&lt;0.05).,"['obese adolescents with insulin resistance', 'obese adolescents with insulin resistance (IR', '15 obese adolescents aged 12-18 years with IR', 'obese adolescents with IR']",['macronutrient- and glycaemic index-matched meals with either high or low II'],"['postprandial hyperinsulinaemia', 'postprandial metabolic responses and appetite sensations', 'feeling of hunger', 'glycaemic index, low insulin index (LGI-LII) and low glycaemic index, high insulin index (LGI-HII', 'postprandial insulin responses', 'serum glucose, insulin and C-peptide levels, and appetite scores']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinemia'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement (procedure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",15.0,0.0682935,The feeling of hunger was also decreased by 25.8% and 27.5% after LGI-LII meal vs. LGI-HII meal during the late and total responses (p&lt;0.05).,"[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Caferoglu', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Health Sciences, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Hatipoglu', 'Affiliation': 'Department of Paediatric Endocrinology, Faculty of Medicine, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gokmen Ozel', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Health Sciences, Hacettepe University, Ankara, Turkey.'}]",The British journal of nutrition,['10.1017/S0007114519001351']
1042,29474851,Active learning improves on-task behaviors in 4th grade children.,"While increased opportunities for physical activity (PA) are a critical, public health need for children, school-based interventions often place teachers in the position to choose between PA and time spent on academic lessons. Active learning is designed to overcome this by combining PA with academic material. Moreover, teachers are likely to be more responsive to change in academic-related outcomes than in PA. This study utilizes a large, cluster randomized control trial in which student attention, or time on task (TOT) and accelerometer-based PA is assessed in conjunction with active learning. Participants were 2716 children (46% male, 46% white) from 28 elementary schools in Central Texas that were assigned to either: 1) active learning (math n = 10; spelling n = 9); or 2) traditional, sedentary academic lessons (n = 9). PA was measured with accelerometers. TOT was measured through a momentary time sampling protocol. A series of three-level (student, classroom, school) regression models estimated the effect of the intervention. The intervention lead to significantly increased TOT. Moreover, the dose of PA (steps) during the intervention was positively associated with the increase in TOT. In contrast, a greater dose of PA was associated with reduced TOT for students in control schools. Race, gender, and SES did not moderate these effects. Planned PA - as a part of an active, academic lesson - positively impacted TOT. In contrast, a traditional, sedentary lesson was associated with lower TOT. This differential impact offers intriguing possibilities to better understand the relationship between PA and academic performance.",2018,The intervention lead to significantly increased TOT.,"['Participants were 2716 children (46% male, 46% white) from 28 elementary schools in Central Texas that were assigned to either: 1', '4th grade children']","['active learning (math n\u202f=\u202f10; spelling n\u202f=\u202f9); or 2) traditional, sedentary academic lessons', 'Active learning']","['TOT', 'task behaviors']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C0243012', 'cui_str': 'Experiential Learning'}, {'cui': 'C0331515', 'cui_str': 'Triticum spelta'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior'}]",2716.0,0.0344585,The intervention lead to significantly increased TOT.,"[{'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Bartholomew', 'Affiliation': 'The University of Texas at Austin, Austin, TX, United States. Electronic address: jbart@austin.utexas.edu.'}, {'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'Golaszewski', 'Affiliation': 'The University of Texas at Austin, Austin, TX, United States.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jowers', 'Affiliation': 'The University of Texas at Austin, Austin, TX, United States.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Korinek', 'Affiliation': 'The University of Texas at Austin, Austin, TX, United States.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Roberts', 'Affiliation': 'The Meadows Center for Preventing Educational Risk, The University of Texas at Austin, United States.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fall', 'Affiliation': 'The Meadows Center for Preventing Educational Risk, The University of Texas at Austin, United States.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Vaughn', 'Affiliation': 'The Meadows Center for Preventing Educational Risk, The University of Texas at Austin, United States.'}]",Preventive medicine,['10.1016/j.ypmed.2018.02.023']
1043,32410608,The role of text messaging intervention in Inner Mongolia among patients with type 2 diabetes mellitus: a randomized controlled trial.,"BACKGROUND


Short messages service (SMS) provides a practical medium for delivering content to address patients to adherence to self-management. The aim of study was to design some patient-centered health education messages, evaluate the feasibility of messages, and explore the effect of this model.
METHODS


The messages were designed by a panel of experts, and SMS Quality Evaluation Questionnaire was used to evaluate their quality. A two-arm randomized controlled trial was conducted to evaluate the effectiveness of this management model. Participants were randomly divided into an intervention group (IG) who received evaluated messages and a control group (CG) who received regular education. The primary outcomes were changes in plasma glucose and control rates, and the secondary outcomes were improvements in diet control, physical activities, weight control, etc. RESULTS: A total of 42 messages covering five main domains: health awareness, diet control, physical activities, living habits and weight control were designed, and the average scores of the messages were 8.0 (SD 0.7), 8.5 (SD 0.6), 7.9 (SD 1.0), 8.0 (SD 0.7), and 8.4 (SD 0.9), respectively. In the SMS intervention, 171 patients with an average age of 55.1 years were involved, including 86 in the CG and 85 in the IG. At 12 months, compared with the control group (CG), the decrease of fasting plasma glucose (FPG) (1.5 vs. 0.4, P = 0.011) and control rate (49.4% vs. 33.3%, P = 0.034), the postprandial glucose (PPG) (5.8 vs. 4.2, P = 0.009) and control rate (57.8% vs. 33.7%, P = 0.002) were better in the intervention group (IG). In terms of self-management, improvements in weight control (49.3% vs. 28.2%, P = 0.031), vegetables consumption (87.3% vs. 29.0%, P < 0.001), fruits consumption (27.5% vs. 7.4%, P = 0.022), and physical activities (84.7% vs. 70.0%, P = 0.036) were better in the IG than in the CG.
CONCLUSIONS


The overall quality of the messages was high. It was effective and feasible to carry out an SMS intervention to improve the behavioral habits of patients with chronic diseases in remote and undeveloped areas.
TRIAL REGISTRATION


Clinicaltrials.gov, ChiCTR1900023445. Registered May 28, 2019--Retrospectively registered.",2020,"It was effective and feasible to carry out an SMS intervention to improve the behavioral habits of patients with chronic diseases in remote and undeveloped areas.
","['patients with type 2 diabetes mellitus', '171 patients with an average age of 55.1\u2009years were involved, including 86 in the CG and 85 in the IG', 'patients with chronic diseases in remote and undeveloped areas']","['intervention group (IG) who received evaluated messages and a control group (CG) who received regular education', 'Short messages service (SMS', 'SMS intervention', 'text messaging intervention']","['fruits consumption', 'fasting plasma glucose (FPG', 'weight control', 'physical activities', 'overall quality', 'diet control, physical activities, weight control, etc', 'postprandial glucose (PPG', 'vegetables consumption', 'behavioral habits', 'control rate', 'changes in plasma glucose and control rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}]",171.0,0.0897911,"It was effective and feasible to carry out an SMS intervention to improve the behavioral habits of patients with chronic diseases in remote and undeveloped areas.
","[{'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Health Statistics, School of Public Health, Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Health Statistics, School of Public Health, Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Maolin', 'Initials': 'M', 'LastName': 'Du', 'Affiliation': 'Department of Health Statistics, School of Public Health, Inner Mongolia Medical University, Hohhot, China. dumaolin2016@163.com.'}, {'ForeName': 'Ruiqi', 'Initials': 'R', 'LastName': 'Hao', 'Affiliation': 'Department of Health Statistics, School of Public Health, Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Huiqiu', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Health Statistics, School of Public Health, Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Chaoli', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'Department of Endocrinology, Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China.'}]",BMC medical informatics and decision making,['10.1186/s12911-020-01129-7']
1044,32410586,Stigma and utilization of treatment for adolescent perinatal depression in Ibadan Nigeria.,"BACKGROUND


Depression is a common and severe disorder among low-income adolescent mothers in low-and middle-income countries where resources for treatment are limited. We wished to identify factors influencing health service utilization for adolescent perinatal depression, in Nigeria to inform new strategies of care delivery.
METHODS


Focus Group Discussions (FGDs) were conducted among purposively selected low-income young mothers (with medical histories of adolescent perinatal depression), and separately with primary care clinicians treating this condition in Ibadan, Nigeria. Participants from this community-based study were from the database of respondents who participated in a previous randomized control trial (RCT) conducted between 2014 and 2016 in 28 primary health care facilities in the 11 Local government areas in Ibadan. Semi-structured interview guides, framed by themes of the Behavioral Model for Vulnerable Populations, was developed to obtain views of participants on the factors that promote or hinder help-seeking and engagement (see additional files 1 & 2). FGDs were conducted, and saturation of themes was achieved after discussions with six groups. Transcripts were analyzed using content analysis.
RESULTS


A total of 42 participants, 17 mothers (who were adolescents at the time of the RCT), and 25 care providers participated in 6 FGDs. The availability of care for perinatal depression at the primary care level was an important enabling factor in healthcare utilization for the adolescents. Perceived health benefits of treatment received for perinatal depression were strong motivation for service use. Significant stigma and negative stereotypes expressed by care providers towards adolescent pregnancy and perinatal depression were obstacles to care. However, individual patient resilience was a major enabling factor, facilitating service engagement. Providers trained in the management of perinatal depression were perceived to deliver more tolerant and supportive care that adolescent mothers valued.
CONCLUSIONS


Participants identified unsupportive and stigmatizing clinic environments towards pregnant and parenting adolescents as significant barriers to accessing available care. Interventions to reduce stigma among healthcare providers may improve services for this vulnerable population.",2020,The availability of care for perinatal depression at the primary care level was an important enabling factor in healthcare utilization for the adolescents.,"['42 participants, 17 mothers (who were adolescents at the time of the RCT), and 25 care providers participated in 6 FGDs', 'Focus Group Discussions (FGDs) were conducted among purposively selected low-income young mothers (with medical histories of adolescent perinatal depression), and separately with primary care clinicians treating this condition in Ibadan, Nigeria', 'adolescent perinatal depression in Ibadan Nigeria', 'Participants from this community-based study were from the database of respondents who participated in a previous randomized control trial (RCT) conducted between 2014 and 2016 in 28 primary health care facilities in the 11 Local government areas in Ibadan']",[],[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282440', 'cui_str': 'Randomized Controlled Trials as Topic'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0559477', 'cui_str': 'Perinatal asphyxia'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0026788', 'cui_str': 'Government, Local'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",[],[],42.0,0.0691441,The availability of care for perinatal depression at the primary care level was an important enabling factor in healthcare utilization for the adolescents.,"[{'ForeName': 'Lola', 'Initials': 'L', 'LastName': 'Kola', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria. lola_kola2004@yahoo.com.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Bennett', 'Affiliation': 'Departments of Family Medicine, University of Washington, Seattle, USA.'}, {'ForeName': 'Amritha', 'Initials': 'A', 'LastName': 'Bhat', 'Affiliation': 'Departments of Family Medicine, University of Washington, Seattle, USA.'}, {'ForeName': 'Olatunde O', 'Initials': 'OO', 'LastName': 'Ayinde', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Bibilola D', 'Initials': 'BD', 'LastName': 'Oladeji', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Dolapo', 'Initials': 'D', 'LastName': 'Abiona', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Jibril', 'Initials': 'J', 'LastName': 'Abdumalik', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Faregh', 'Affiliation': 'Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Pamela Y', 'Initials': 'PY', 'LastName': 'Collins', 'Affiliation': 'Psychiatry and Behavioral Science, University of Washington, Seattle, USA.'}, {'ForeName': 'Oye', 'Initials': 'O', 'LastName': 'Gureje', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-02970-4']
1045,32410596,Interpretation of within-group change in randomised trials.,"In medicine, it is common to observe improvement after intervention, at least partly because patients present for care in extremis and would have improved without intervention. Controlling for this counterfactual explanation for improvement is the principle reason to conduct a trial in which patients are randomised to treatment or a control group. Accordingly, it is not reasonable to infer that both interventions are effective when the groups show similar improvements in outcome.",2020,"Accordingly, it is not reasonable to infer that both interventions are effective when the groups show similar improvements in outcome.",[],[],[],[],[],[],,0.069099,"Accordingly, it is not reasonable to infer that both interventions are effective when the groups show similar improvements in outcome.","[{'ForeName': 'Kypros', 'Initials': 'K', 'LastName': 'Kypri', 'Affiliation': 'Centre for Clinical Epidemiology and Biostatistics, School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia. kypros.kypri@newcastle.edu.au.'}]",BMC psychiatry,['10.1186/s12888-020-02641-w']
1046,32409986,A pilot study of a group-based perinatal depression intervention on reducing depressive symptoms and improving maternal-fetal attachment and maternal sensitivity.,"To conduct a pilot study of a group-based perinatal depression intervention, the Mothers and Babies Course, on depressive symptomatology, maternal-fetal attachment, and maternal sensitivity, 60 pregnant women with moderate to severe depressive symptomatology were randomized to a 6-week intervention or usual care group at their initial prenatal care visit. Measures of depressive symptomatology and maternal-fetal attachment were collected at baseline and 36 weeks gestation. At 12 weeks postpartum, participants completed a measure of depressive symptomatology, and an objective measure of maternal sensitivity was collected. Participants randomized to the intervention group completed an average of 5.2 sessions, and 70% of women completed all six sessions. Exploratory analyses showed that at 12 weeks postpartum, participants randomized to the intervention group had an 8.32-point decrease from baseline on the Edinburgh Postnatal Depression Scale (EPDS) as compared to a 4.59-point decrease among participants randomized to usual care. Participants randomized to the intervention group had a mean change score of 12.60 in maternal-fetal attachment via the Maternal Fetal Attachment Scale (MFAS) as compared to 4.60 among participants in usual care. Maternal sensitivity scores, assessed via the Nursing Child Assessment Satellite Training-Feeding Scale (NCAST-Feeding), were higher at 12 weeks postpartum for women in the intervention group as compared to women in usual care (59.2 and 51.8, respectively). Our pilot study findings provide preliminary support for the benefits of a perinatal depression intervention, delivered in a group setting, on reducing depressive symptomatology, and improving maternal-fetal attachment and maternal sensitivity. Further research, conducted with larger samples, is necessary to determine the effect of this intervention on indicators of maternal attachment.",2020,Participants randomized to the intervention group had a mean change score of 12.60 in maternal-fetal attachment via the Maternal Fetal Attachment Scale (MFAS) as compared to 4.60 among participants in usual care.,"['Mothers and Babies Course, on depressive symptomatology, maternal-fetal attachment, and maternal sensitivity, 60 pregnant women with moderate to severe depressive symptomatology']","['6-week intervention or usual care group at their initial prenatal care visit', 'group-based perinatal depression intervention']","['depressive symptomatology and maternal-fetal attachment', 'Edinburgh Postnatal Depression Scale (EPDS', 'depressive symptomatology', 'Maternal sensitivity scores, assessed via the Nursing Child Assessment Satellite Training-Feeding Scale (NCAST-Feeding', 'maternal-fetal attachment via the Maternal Fetal Attachment Scale (MFAS', 'depressive symptoms and improving maternal-fetal attachment and maternal sensitivity', 'depressive symptomatology, and improving maternal-fetal attachment and maternal sensitivity']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0559477', 'cui_str': 'Perinatal asphyxia'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036238', 'cui_str': 'Associated Viruses'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",60.0,0.0857981,Participants randomized to the intervention group had a mean change score of 12.60 in maternal-fetal attachment via the Maternal Fetal Attachment Scale (MFAS) as compared to 4.60 among participants in usual care.,"[{'ForeName': 'Jeanne L', 'Initials': 'JL', 'LastName': 'Alhusen', 'Affiliation': 'University of Virginia School of Nursing, 225 Jeanette Lancaster Avenue, Charlottesville, VA, 22903, USA. Jla7e@virginia.edu.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Hayat', 'Affiliation': 'Georgia State University, Urban Life, 140 Decatur Street, Atlanta, GA, 30303, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Borg', 'Affiliation': 'University of Virginia School of Nursing, 225 Jeanette Lancaster Avenue, Charlottesville, VA, 22903, USA.'}]",Archives of women's mental health,['10.1007/s00737-020-01032-0']
1047,32410152,Letter to the Editor Re: Sera of Obese Type 2 Diabetic Patients Undergoing Metabolic Surgery Instead of Conventional Treatment Exert Beneficial Effects on Beta Cell Survival and Function: Results of a Randomized Clinical Study.,,2020,,['Sera of Obese Type 2 Diabetic Patients Undergoing'],"['Metabolic Surgery', 'Letter to the Editor Re']",['Beta Cell Survival and Function'],"[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}]","[{'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.0341806,,"[{'ForeName': 'Walter J', 'Initials': 'WJ', 'LastName': 'Pories', 'Affiliation': 'Department of Surgery, Brody School of Medicine, East Carolina University, 600 Moye Blvd, Greenville, NC, 27834, USA. poriesw@ecu.edu.'}, {'ForeName': 'G Lynis', 'Initials': 'GL', 'LastName': 'Dohm', 'Affiliation': 'Department of Surgery, Brody School of Medicine, East Carolina University, 600 Moye Blvd, Greenville, NC, 27834, USA.'}]",Obesity surgery,['10.1007/s11695-020-04665-3']
1048,32410636,Augmented reality-based navigation increases precision of pedicle screw insertion.,"BACKGROUND


Precise insertion of pedicle screws is important to avoid injury to closely adjacent neurovascular structures. The standard method for the insertion of pedicle screws is based on anatomical landmarks (free-hand technique). Head-mounted augmented reality (AR) devices can be used to guide instrumentation and implant placement in spinal surgery. This study evaluates the feasibility and precision of AR technology to improve precision of pedicle screw insertion compared to the current standard technique.
METHODS


Two board-certified orthopedic surgeons specialized in spine surgery and two novice surgeons were each instructed to drill pilot holes for 40 pedicle screws in eighty lumbar vertebra sawbones models in an agar-based gel. One hundred and sixty pedicles were randomized into two groups: the standard free-hand technique (FH) and augmented reality technique (AR). A 3D model of the vertebral body was superimposed over the AR headset. Half of the pedicles were drilled using the FH method, and the other half using the AR method.
RESULTS


The average minimal distance of the drill axis to the pedicle wall (MAPW) was similar in both groups for expert surgeons (FH 4.8 ± 1.0 mm vs. AR 5.0 ± 1.4 mm, p = 0.389) but for novice surgeons (FH 3.4 mm ± 1.8 mm, AR 4.2 ± 1.8 mm, p = 0.044). Expert surgeons showed 0 primary drill pedicle perforations (PDPP) in both the FH and AR groups. Novices showed 3 (7.5%) PDPP in the FH group and one perforation (2.5%) in the AR group, respectively (p > 0.005). Experts showed no statistically significant difference in average secondary screw pedicle perforations (SSPP) between the AR and the FH set 6-, 7-, and 8-mm screws (p > 0.05). Novices showed significant differences of SSPP between most groups: 6-mm screws, 18 (45%) vs. 7 (17.5%), p = 0.006; 7-mm screws, 20 (50%) vs. 10 (25%), p = 0.013; and 8-mm screws, 22 (55%) vs. 15 (37.5%), p = 0.053, in the FH and AR group, respectively. In novices, the average optimal medio-lateral convergent angle (oMLCA) was 3.23° (STD 4.90) and 0.62° (STD 4.56) for the FH and AR set screws (p = 0.017), respectively. Novices drilled with a higher precision with respect to the cranio-caudal inclination angle (CCIA) category (p = 0.04) with AR.
CONCLUSION


In this study, the additional anatomical information provided by the AR headset superimposed to real-world anatomy improved the precision of drilling pilot holes for pedicle screws in a laboratory setting and decreases the effect of surgeon's experience. Further technical development and validations studies are currently being performed to investigate potential clinical benefits of the herein described AR-based navigation approach.",2020,Experts showed no statistically significant difference in average secondary screw pedicle perforations (SSPP) between the AR and the FH set,"['Two board-certified orthopedic surgeons specialized in spine surgery and two novice surgeons', 'One hundred and sixty pedicles']","['Head-mounted augmented reality (AR) devices', 'standard free-hand technique (FH) and augmented reality technique (AR']","['SSPP', 'average minimal distance of the drill axis to the pedicle wall (MAPW', 'average secondary screw pedicle perforations (SSPP', 'average optimal medio-lateral convergent angle (oMLCA', 'primary drill pedicle perforations (PDPP']","[{'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0334891', 'cui_str': 'Orthopedic surgeon'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0456605', 'cui_str': 'Pedicle'}]","[{'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0181909', 'cui_str': 'Mount'}, {'cui': 'C5197824', 'cui_str': 'Mixed Reality'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0456980', 'cui_str': 'Hand endodontic technique'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0456605', 'cui_str': 'Pedicle'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0324815', 'cui_str': 'Mandrillus leucophaeus'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",160.0,0.0294771,Experts showed no statistically significant difference in average secondary screw pedicle perforations (SSPP) between the AR and the FH set,"[{'ForeName': 'Cyrill', 'Initials': 'C', 'LastName': 'Dennler', 'Affiliation': 'Spine Division, University Hospital Balgrist, University of Zürich, Forchstrasse 340, 8008, Zurich, Switzerland. cyrill.dennler@gmail.com.'}, {'ForeName': 'Laurenz', 'Initials': 'L', 'LastName': 'Jaberg', 'Affiliation': 'Spine Division, University Hospital Balgrist, University of Zürich, Forchstrasse 340, 8008, Zurich, Switzerland.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Spirig', 'Affiliation': 'Spine Division, University Hospital Balgrist, University of Zürich, Forchstrasse 340, 8008, Zurich, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Agten', 'Affiliation': 'Department of Radiology, University Hospital Balgrist, University of Zürich, Zurich, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Götschi', 'Affiliation': 'Laboratory for Biomechanics, University Hospital Balgrist, University of Zürich, Zurich, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Fürnstahl', 'Affiliation': 'Computer Assisted Research and Development Group, University Hospital Balgrist, University of Zürich, Zurich, Switzerland.'}, {'ForeName': 'Mazda', 'Initials': 'M', 'LastName': 'Farshad', 'Affiliation': 'Spine Division, University Hospital Balgrist, University of Zürich, Forchstrasse 340, 8008, Zurich, Switzerland.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01690-x']
1049,32410200,Effect of Photobiomodulation on Ecchymosis after Rhinoplasty: A Randomized Single-Blind Controlled Trial.,"BACKGROUND


This study was conducted to compare the effect of photobiomodulation therapy (low-level laser therapy) on ecchymosis after rhinoplasty.
SUBJECTS AND METHODS


Sixty rhinoplasty candidates were randomly divided into two groups. Photobiomodulation, including red light (660 nm), infrared light (840 nm), and infrared laser, was used in the first group on the first postoperative day, and its effect on periorbital ecchymosis was evaluated.
RESULTS


The findings showed that low-power laser reduced ecchymosis significantly (p = 0.005 * ).
CONCLUSION


Photobiomodulation may be effectively used for reducing ecchymosis after rhinoplasty.
LEVEL OF EVIDENCE II


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266. RCT registration number is IRCT20080820001056N3.",2020,"The findings showed that low-power laser reduced ecchymosis significantly (p = 0.005 * ).
",['Sixty rhinoplasty candidates'],"['Photobiomodulation, including red light (660\xa0nm), infrared light (840\xa0nm), and infrared laser', 'photobiomodulation therapy (low-level laser therapy', 'Photobiomodulation']","['Ecchymosis', 'periorbital ecchymosis', 'ecchymosis']","[{'cui': 'C0035467', 'cui_str': 'Rhinoplasty'}]","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0563227', 'cui_str': 'Red light'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0021431', 'cui_str': 'Infrared radiation'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}]","[{'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C2053461', 'cui_str': 'Periorbital ecchymosis'}]",,0.0712924,"The findings showed that low-power laser reduced ecchymosis significantly (p = 0.005 * ).
","[{'ForeName': 'Somaye', 'Initials': 'S', 'LastName': 'Karimi', 'Affiliation': 'Otolaryngology Research Center, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Bagherkhan Street, Chamran Highway, Tehran, 141973141, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sadeghi', 'Affiliation': 'Otolaryngology Research Center, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Bagherkhan Street, Chamran Highway, Tehran, 141973141, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Amali', 'Affiliation': 'Otolaryngology Research Center, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Bagherkhan Street, Chamran Highway, Tehran, 141973141, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Saedi', 'Affiliation': 'Otolaryngology Research Center, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Bagherkhan Street, Chamran Highway, Tehran, 141973141, Iran. saedi@tums.ac.ir.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01760-9']
1050,31374188,"Medroxyprogesterone acetate concentrations among HIV-infected depot-medroxyprogesterone acetate users receiving antiretroviral therapy in Lilongwe, Malawi.","OBJECTIVE


To compare medroxyprogesterone acetate (MPA) concentrations between HIV-positive women on antiretroviral therapy (ART) and HIV-negative women initiating depot medroxyprogesterone (DMPA) injectable.
STUDY DESIGN


Secondary analysis of 28 HIV-positive women on non-nucleoside reverse transcriptase inhibitor-containing ART regimens and 10 HIV-negative women randomized to initiate DMPA in a clinical trial of progestin contraception in Malawi.
RESULTS


MPA concentrations were significantly lower among HIV-positive women on ART, compared with HIV-negative women, at week 4 and week 13 (p=.03 for both), but not at day 3 or week 26 post-DMPA initiation.
CONCLUSIONS


Antiretroviral medications may affect MPA metabolism in HIV-positive African women.",2019,"RESULTS


MPA concentrations were significantly lower among HIV-positive women on ART, compared with HIV-negative women, at week 4 and week 13 (p=.03 for both), but not at day 3 or week 26 post-DMPA initiation.
","['28 HIV-positive women on non-nucleoside reverse transcriptase inhibitor-containing ART regimens and 10 HIV-negative women', 'HIV-positive African women', 'HIV-positive women on antiretroviral therapy (ART) and HIV-negative women initiating depot', 'HIV-infected depot-medroxyprogesterone acetate users receiving antiretroviral therapy in Lilongwe, Malawi']","['medroxyprogesterone (DMPA', 'DMPA', 'progestin contraception', 'medroxyprogesterone acetate (MPA', 'Medroxyprogesterone acetate']","['MPA concentrations', 'MPA metabolism']","[{'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3541376', 'cui_str': 'Non-nucleoside reverse transcriptase inhibitors'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0065864', 'cui_str': 'medroxyprogesterone acetate'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}]","[{'cui': 'C0025147', 'cui_str': 'Medroxyprogesterone'}, {'cui': 'C0067376', 'cui_str': 'N,N-dimethyl-para-anisidine'}, {'cui': 'C0033306', 'cui_str': 'Progestins'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}, {'cui': 'C0065864', 'cui_str': 'medroxyprogesterone acetate'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",28.0,0.386095,"RESULTS


MPA concentrations were significantly lower among HIV-positive women on ART, compared with HIV-negative women, at week 4 and week 13 (p=.03 for both), but not at day 3 or week 26 post-DMPA initiation.
","[{'ForeName': 'Yasaman', 'Initials': 'Y', 'LastName': 'Zia', 'Affiliation': 'Centers for Disease Control and Prevention, Division of Reproductive Health, Atlanta, GA; Association of Schools and Programs of Public Health, Washington, DC. Electronic address: yaszia@gmail.com.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Tang', 'Affiliation': 'University of North Carolina- Chapel Hill, School of Medicine, Chapel Hill, NC; UNC Project-Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Lameck', 'Initials': 'L', 'LastName': 'Chinula', 'Affiliation': 'UNC Project-Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Tegha', 'Affiliation': 'UNC Project-Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Frank Z', 'Initials': 'FZ', 'LastName': 'Stanczyk', 'Affiliation': 'University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Athena P', 'Initials': 'AP', 'LastName': 'Kourtis', 'Affiliation': 'Centers for Disease Control and Prevention, Division of Reproductive Health, Atlanta, GA.'}]",Contraception,['10.1016/j.contraception.2019.07.144']
1051,31101534,"Docetaxel plus cisplatin and S-1 versus cisplatin and S-1 in patients with advanced gastric cancer (JCOG1013): an open-label, phase 3, randomised controlled trial.","BACKGROUND


We investigated the superiority of docetaxel plus cisplatin and S-1 compared with cisplatin and S-1 in chemotherapy-naive patients with advanced gastric cancer.
METHODS


In this open-label, phase 3, randomised controlled trial, patients were recruited from 56 hospitals in Japan. We enrolled individuals aged 20-75 years who had unresectable or recurrent gastric cancer, had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, had received no previous chemotherapy (except adjuvant chemotherapy completed 24 weeks before reccurence), radiotherapy, or hormonal therapy, could take drugs orally, and had adequate organ function. Patients were randomly assigned (1:1) to receive docetaxel plus cisplatin and S-1 (docetaxel 40 mg/m 2  and cisplatin 60 mg/m 2  on day 1 intravenously, and S-1 40-60 mg twice a day orally for 2 weeks, every 4 weeks) or cisplatin and S-1 (cisplatin 60 mg/m 2  intravenously on day 8, and S-1 40-60 mg orally twice a day for 3 weeks, every 5 weeks). Randomisation was done centrally with the minimisation method, with a random component balancing for institution, ECOG performance status (0 vs 1), disease status at enrolment (unresectable vs recurrent), measurable lesion (yes vs no), number of metastatic sites (0-1 vs ≥2), and histological type (differentiated vs undifferentiated). Neither investigators or patients were masked to the study treatment. The primary endpoint was overall survival in the intention-to-treat population. The study is registered with UMIN-CTR, number UMIN000007652.
FINDINGS


Between April 3, 2012, and March 18, 2016, 741 patients were randomly assigned to receive docetaxel plus cisplatin and S-1 (n=370) or cisplatin and S-1 (n=371). Median overall survival was 14·2 months (95% CI 12·9-15·9) in the docetaxel plus cisplatin and S-1 group and 15·3 months (14·2-16·2) in the cisplatin and S-1 group (hazard ratio [HR] 0·99 [95% CI 0·85-1·16]; one-sided stratified log-rank p=0·47). The most common grade 3 or worse adverse events were neutropenia (209 [59%] of 357 patients in the docetaxel plus cisplatin and S-1 group vs 117 [32%] of 365 patients in the cisplatin and S-1 group), leukopenia (120 [34%] vs 60 [16%]), and anorexia (94 [26%] vs 81 [22%]). The deaths of one patient in the cisplatin and S-1 group and in three patients in the docetaxel plus cisplatin and S-1 group were deemed treatment-related.
INTERPRETATION


The addition of docetaxel to cisplatin and S-1 did not improve overall survival in chemotherapy-naive Japanese patients with advanced gastric cancer. Therefore, cisplatin and S-1 remains the standard first-line chemotherapy.
FUNDING


Ministry of Health, Labour and Welfare and Japan Agency for Medical Research and Development.",2019,Median overall survival was 14·2 months (95% CI 12·9-15·9) in the docetaxel plus cisplatin and S-1 group and 15·3 months (14·2-16·2) in the cisplatin and S-1 group (hazard ratio [HR] 0·99,"['patients were recruited from 56 hospitals in Japan', 'Between April 3, 2012, and March 18, 2016', 'chemotherapy-naive Japanese patients with advanced gastric cancer', 'patients with advanced gastric cancer (JCOG1013', 'enrolled individuals aged 20-75 years who had unresectable or recurrent gastric cancer, had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, had received no previous chemotherapy (except adjuvant chemotherapy completed 24 weeks before reccurence', 'chemotherapy-naive patients with advanced gastric cancer', '741 patients']","['cisplatin', 'docetaxel plus cisplatin and S-1 (docetaxel 40 mg/m 2  and cisplatin', 'cisplatin and S-1', 'cisplatin and S-1 ', 'docetaxel plus cisplatin and S-1 (n=370) or cisplatin and', 'Docetaxel plus cisplatin and S-1 versus cisplatin and S-1', 'docetaxel plus cisplatin', 'docetaxel to cisplatin and S-1', 'radiotherapy, or hormonal therapy', 'docetaxel plus cisplatin and S-1']","['number of metastatic sites', 'leukopenia', 'neutropenia', 'anorexia', 'Median overall survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",741.0,0.21854,Median overall survival was 14·2 months (95% CI 12·9-15·9) in the docetaxel plus cisplatin and S-1 group and 15·3 months (14·2-16·2) in the cisplatin and S-1 group (hazard ratio [HR] 0·99,"[{'ForeName': 'Yasuhide', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Comprehensive Cancer Center, National Center for Global Health and Medicine, Shinjuku-ku, Tokyo, Japan; Department of Medical Oncology, Hamamatsu University School of Medicine, Shizuoka, Japan; Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan. Electronic address: yayamada@hosp.ncgm.go.jp.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Junki', 'Initials': 'J', 'LastName': 'Mizusawa', 'Affiliation': 'Japan Clinical Oncology Group Data Center and Operations Office, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Iwasa', 'Affiliation': 'Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Shigenori', 'Initials': 'S', 'LastName': 'Kadowaki', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Chikusa-ku, Nagoya, Aichi, Japan.'}, {'ForeName': 'Norisuke', 'Initials': 'N', 'LastName': 'Nakayama', 'Affiliation': 'Department of Gastroenterology, Kanagawa Cancer Center Hospital, Asahi-ku, Yokohama, Kanagawa, Japan.'}, {'ForeName': 'Mizutomo', 'Initials': 'M', 'LastName': 'Azuma', 'Affiliation': 'Department of Gastroenterology, Kitasato University School of Medicine, Minami, Sagamihara, Kanagawa, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Gastroenterology, Hyogo Cancer Center, Akashi, Hyogo, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': 'Department of Medical Oncology, Kindai University, Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Keisho', 'Initials': 'K', 'LastName': 'Chin', 'Affiliation': 'Department of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Koto-ku, Tokyo, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Hata', 'Affiliation': 'Department of Surgery, National Hospital Organization Kyoto Medical Center, Fushimi-ku, Kyoto, Japan.'}, {'ForeName': 'Mikihito', 'Initials': 'M', 'LastName': 'Nakamori', 'Affiliation': 'Second Department of Surgery, School of Medicine, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Gastroenterology, Saitama Cancer Center, Inamachi, Kitaadachi-gun, Saitama, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Yasui', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Katayama', 'Affiliation': 'Japan Clinical Oncology Group Data Center and Operations Office, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Fukuda', 'Affiliation': 'Japan Clinical Oncology Group Data Center and Operations Office, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Takaki', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Gastrointestinal Surgery, Kanagawa Cancer Center Hospital, Asahi-ku, Yokohama, Kanagawa, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Sasako', 'Affiliation': 'Department of Surgery, Hyogo College of Medicine, Fushimi-ku Mukogawa-cho, Nishinomiya-shi, Hyogo, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Terashima', 'Affiliation': 'Division of Gastric Surgery, Shizuoka Cancer Center, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30083-4']
1052,31116908,Impact of percutaneous closure device type on vascular and bleeding complications after TAVR: A post hoc analysis from the BRAVO-3 randomized trial.,"BACKGROUND/OBJECTIVE


Prostar XL (PS) and ProGlide (PG) are common vascular closure devices (VCD) used in TAVR via transfemoral vascular approach. The impact of these VCD on vascular and bleeding complications remains unclear.
METHODS


The BRAVO-3 trial randomized 802 patients undergoing transfemoral TAVR. We stratified patients according to type of VCD used and examined the 30-day incidence of major or minor vascular complications, major bleeding (BARC ≥3b), AKI and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction or stroke).
RESULTS


A total of 746 (93%) patients were treated with either PS (n = 352, 47%) or PG (n = 394, 53%) VCD, without significant differences in successful deployment rate (PS 322 [91.2%] vs. PG 373 [94.2%] respectively, p = .20). PG was associated with a significantly lower incidence of major or minor vascular complications, compared to PS (adjusted OR: 0.54; 95% CI: 0.37-0.80; p < .01). Rates of acute kidney injury were also lower with the PG device. There was no significant difference between bleeding, MACCE, and death.
CONCLUSIONS


Compared to PS, the PG VCD was associated with a lower rate of major or minor vascular complications and lower rates of AKI after transfemoral TAVR.",2019,"Compared to PS, the PG VCD was associated with a lower rate of major or minor vascular complications and lower rates of AKI after transfemoral TAVR.",['802 patients undergoing transfemoral TAVR'],"['TAVR', 'percutaneous closure device type', 'Prostar XL (PS) and ProGlide (PG', 'VCD']","['incidence of major or minor vascular complications', 'Rates of acute kidney injury', 'successful deployment rate', '30-day incidence of major or minor vascular complications, major bleeding (BARC ≥3b), AKI and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction or stroke', 'bleeding, MACCE, and death', 'vascular and bleeding complications', 'rate of major or minor vascular complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",802.0,0.534714,"Compared to PS, the PG VCD was associated with a lower rate of major or minor vascular complications and lower rates of AKI after transfemoral TAVR.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Power', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai New York City, New York.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schäfer', 'Affiliation': 'Division of Cardiology, University Heart Center, Hamburg, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Guedeney', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai New York City, New York.'}, {'ForeName': 'Bimmer E', 'Initials': 'BE', 'LastName': 'Claessen', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai New York City, New York.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Sartori', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai New York City, New York.'}, {'ForeName': 'Sabato', 'Initials': 'S', 'LastName': 'Sorrentino', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai New York City, New York.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lefèvre', 'Affiliation': 'Department of Cardiology, Hôpital Privé Jacques Cartier, Massy, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kupatt', 'Affiliation': 'Department of Cardiology, LMU Munich, Munich, Germany.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Tchetche', 'Affiliation': 'Department of Cardiology, Clinique Pasteur Toulouse, Toulouse, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Dumonteil', 'Affiliation': 'Department of Cardiology, CHU Rangueil, Toulouse, France.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Webb', 'Affiliation': ""Department of Cardiology, St. Paul's Hospital, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Colombo', 'Affiliation': 'Interventional Cardiology Unit, San Raffaele Hospital, Milan, Italy.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology Bern University Hosp, Bern, Switzerland.'}, {'ForeName': 'Jurriën M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'Department of Cardiology, St. Antonius Ziekenhuis, Nieuwegein, Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hildick-Smith', 'Affiliation': 'Department of Interventional Cardiology, Sussex Cardiac Center, Brighton, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Boekstegers', 'Affiliation': 'Helios Heart Center Siegburg, Siegburg, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Linke', 'Affiliation': 'Herzzentrum Leipzig, Leipzig, Germany.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Tron', 'Affiliation': 'Department of Cardiology, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Belle', 'Affiliation': 'Department of Cardiology and INSERM UMR 1011, CHU Lille, Lille, France.'}, {'ForeName': 'Anita W', 'Initials': 'AW', 'LastName': 'Asgar', 'Affiliation': 'Institute de Cardiologie de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Raban', 'Initials': 'R', 'LastName': 'Jeger', 'Affiliation': 'Cardiology, University Hospital Basel, University of Basel, Switzerland.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Sardella', 'Affiliation': 'Division of Cardiology, Policlinico Umberto I, Rome, Italy.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Hink', 'Affiliation': 'Department of Cardiology, Universitätsmedizin Mainz, Mainz, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Husser', 'Affiliation': 'Deutsches Herzzentrum München, Munich, Germany.'}, {'ForeName': 'Eberhard', 'Initials': 'E', 'LastName': 'Grube', 'Affiliation': 'Universitätsklinikum Bonn, Bonn, Germany.'}, {'ForeName': 'Ilknur', 'Initials': 'I', 'LastName': 'Lechthaler', 'Affiliation': 'The Medicines Company, Zurich, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wijngaard', 'Affiliation': 'The Medicines Company, Zurich, Switzerland.'}, {'ForeName': 'Prodromos', 'Initials': 'P', 'LastName': 'Anthopoulos', 'Affiliation': 'The Medicines Company, Zurich, Switzerland.'}, {'ForeName': 'Efthymios N', 'Initials': 'EN', 'LastName': 'Deliargyris', 'Affiliation': 'Science and Strategy Consulting Group, Basking Ridge, New Jersey.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Bernstein', 'Affiliation': 'Science and Strategy Consulting Group, Basking Ridge, New Jersey.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hengstenberg', 'Affiliation': 'Department of Internal Medicine II, Division of Cardiology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai New York City, New York.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Dangas', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai New York City, New York.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28295']
1053,31116913,Impact of intravascular ultrasound-guided drug-eluting stent implantation on patients with chronic kidney disease: Results from ULTIMATE trial.,"OBJECTIVES


This study aimed to investigate the impacts of intravascular ultrasound (IVUS)-guided drug-eluting stent (DES) implantation on patients with chronic kidney disease (CKD) based on the ULTIMATE trial.
BACKGROUND


IVUS-guided DES implantation improves clinical outcomes in complex lesions. However, routine IVUS guidance in patients with CKD remains controversial.
METHODS


CKD was defined as an estimated glomerular filtration rate (eGFR) <60 mL min -1  1.73 m -2  . The primary end point was target vessel failure (TVF) at 12 months, including cardiac death, target vessel myocardial infarction, and clinically driven target vessel revascularization.
RESULTS


eGFR was available in 1,443 patients, of whom 723 were in the IVUS guidance group, and 720 were in the angiography guidance group. Finally, CKD was present in 349 (24.2%) patients. At 12 months, TVF in the CKD group was 7.2%, which was significantly higher than 3.2% in the non-CKD group (p = .001). Moreover, there were 25 TVFs in the CKD patients, with 7 (3.9%) TVFs in the IVUS group and 18 (10.7%) TVFs in the angiography group (hazard ratio [HR]: 0.35; 95% confidence interval [CI]: 0.15-0.84; p = .01), whereas 35 TVFs occurred in patients without CKD, with 14 (2.6%) TVFs in the IVUS group and 21 (3.8%) TVFs in the angiography group (HR: 0.67; 95% CI: 0.34-1.32; p = .25; p for interaction = .24).
CONCLUSIONS


This study demonstrated that CKD patients undergoing DES implantations were associated with a higher risk of TVF at 12 months. More importantly, the risk of TVF in the CKD patients could be significantly decreased through IVUS guidance.
CLINICAL TRIAL


NCT02215915.",2019,"TVFs in the angiography group (HR: 0.67; 95% CI: 0.34-1.32; p = .25; p for interaction = .24).
","['1,443 patients, of whom 723 were in the IVUS guidance group, and 720 were in the angiography guidance group', 'patients with chronic kidney disease', 'patients with chronic kidney disease (CKD', 'CKD patients undergoing DES implantations', 'patients with CKD']","['IVUS-guided DES implantation', 'intravascular ultrasound (IVUS)-guided drug-eluting stent (DES) implantation', 'intravascular ultrasound-guided drug-eluting stent implantation']","['TVFs', 'target vessel failure (TVF) at 12\u2009months, including cardiac death, target vessel myocardial infarction, and clinically driven target vessel revascularization', 'risk of TVF', 'glomerular filtration rate (eGFR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517866', 'cui_str': 'Seven hundred and twenty-three'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517865', 'cui_str': 'Seven hundred and twenty'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]","[{'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}]",,0.0580723,"TVFs in the angiography group (HR: 0.67; 95% CI: 0.34-1.32; p = .25; p for interaction = .24).
","[{'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Ge', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Leng', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': ""Department of Cardiology, Changshu No. 1 People's Hospital, Changshu, China.""}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': ""Department of Cardiology, The First People's Hospital of Taicang, Taicang, China.""}, {'ForeName': 'Xuesong', 'Initials': 'X', 'LastName': 'Qian', 'Affiliation': ""Department of Cardiology, The First People's Hospital of Zhangjiagang, Zhangjiagang, China.""}, {'ForeName': 'Qihua', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Changzhou Traditional Chinese Medicine Hospital, Changzhou, China.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Department of Cardiology, The Second Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Chonghao', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Wuxi Third People's Hospital, Wuxi, China.""}, {'ForeName': 'Shao-Liang', 'Initials': 'SL', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28308']
1054,32410198,The Role of Skin Thickness in the Choice of a Rhinoplasty Technique for Thin-Skinned Patients: Analysis of Long-Term Results and Patient Satisfaction.,"INTRODUCTION


This randomized controlled study aimed to analyse the long-term results of thin-skinned patients who underwent rhinoplasty.
MATERIALS AND METHODS


All the included study patients had the following characteristics: underwent primary rhinoplasty for functional and/or cosmetic problems, were thin-skinned, had been followed for almost 2 years, underwent both standard pre- and post-operative photography, had a good understanding of the Italian language, and had signed a consent form for inclusion in the study. The patients were randomly divided into 4 groups as follows: group 1, camouflage of the dorsum by diced cartilage; group 2, camouflage of the dorsum with lipofilling; group 3, camouflage of the dorsum by a temporal fascia graft; and group 4 (control group), without camouflage of the dorsum. Patients answered the Italian version of the FACE-Q rhinoplasty module. The Obagi skin pinch test was used to measure nasal skin thickness. We compared pre- and post-operative patient satisfaction with the appearance of their nose between the 4 patient groups by the Chi-squared test for unpaired data. Two plastic surgeons reviewed all the post-operative photographs of the study patients and rated the photographs on a scale of 1 to 5.
RESULTS


A total of 101 patients who underwent primary rhinoplasty between January 2016 and March 2018 in our department of plastic surgery and satisfied the inclusion criteria were enrolled in this study. The mean patient age was 38.5 years. The mean follow-up time was 2.5 years. The differences between the preoperative and post-operative FACE-Q values for group 1 were significant (P < 0.01), whereas the differences between the preoperative and post-operative FACE-Q values for the other groups were not significant. The results for group 1 patients remained stable over the long-term follow-up compared with the results for other groups (P < 0.01). Groups 2 and 4 underwent more secondary procedures than groups 1 and 3 (P < 0.01). The 2 reviewers determined that patient groups 1 and 3 obtained more satisfactory outcomes than groups 1 and 4 (P < 0.01).
CONCLUSIONS


This was the first randomized study to demonstrate that diced cartilage grafts used for thin-skinned patients was the best approach for obtaining a satisfactory long-term outcome and durable natural appearance.
LEVEL OF EVIDENCE I


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.",2020,The results for group 1 patients remained stable over the long-term follow-up compared with the results for other groups (P < 0.01).,"['All the included study patients had the following characteristics: underwent primary rhinoplasty for functional and/or cosmetic problems, were thin-skinned, had been followed for almost 2\xa0years, underwent both standard pre- and post-operative photography, had a good understanding of the Italian language, and had signed a consent form for inclusion in the study', '101 patients who underwent primary rhinoplasty between January 2016 and March 2018 in our department of plastic surgery and satisfied the inclusion criteria were enrolled in this study', 'thin-skinned patients who underwent rhinoplasty', 'mean patient age was 38.5\xa0years']","['diced cartilage grafts', 'camouflage of the dorsum by diced cartilage; group 2, camouflage of the dorsum with lipofilling; group 3, camouflage of the dorsum by a temporal fascia graft; and group 4 (control group), without camouflage of the dorsum']","['preoperative and post-operative FACE-Q values', 'satisfactory outcomes', 'Skin Thickness', 'nasal skin thickness']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0035467', 'cui_str': 'Rhinoplasty'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0009797', 'cui_str': 'Informed Consent Forms'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0038911', 'cui_str': 'Plastic surgery - specialty'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1271247', 'cui_str': 'Grafting of cartilage'}, {'cui': 'C0004600', 'cui_str': 'Back'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0225213', 'cui_str': 'Temporal fascia structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0423756', 'cui_str': 'Thickness of skin'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}]",101.0,0.030166,The results for group 1 patients remained stable over the long-term follow-up compared with the results for other groups (P < 0.01).,"[{'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Barone', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy. maurosabbarone@gmail.com.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Cogliandro', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Salzillo', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ciarrocchi', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Panasiti', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Coppola', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Russo', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Tenna', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Persichetti', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01763-6']
1055,31171470,Daily Passive Muscle Stretching Improves Flow-Mediated Dilation of Popliteal Artery and 6-minute Walk Test in Elderly Patients with Stable Symptomatic Peripheral Artery Disease.,"BACKGROUND


Patients with peripheral arterial disease (PAD) often have walking impairment due to insufficient oxygen supply to skeletal muscle. In aged rats, we have shown that daily stretching of calf muscles improves endothelium-dependent dilation of arterioles from the soleus muscle and increases capillarity and muscle blood flow during exercise. Therefore, we hypothesized that daily muscle stretching of calf muscles would improve endothelium-dependent vasodilation of the popliteal artery and walking function in PAD patients.
METHODS


We performed a randomized, non-blinded, crossover study whereby 13 patients with stable symptomatic PAD were randomized to undergo either 4 weeks of passive calf muscle stretching (ankle dorsiflexion applied 30 min/d, 5 days/wk) followed by 4 weeks of no muscle stretching and vice versa. Endothelium-dependent flow-mediated dilation (FMD) and endothelium-independent nitroglycerin-induced dilation of the popliteal artery and 6 minute walk test (6MWT) were evaluated at baseline and after each 4 week interval.
RESULTS


After 4 weeks of muscle stretching, FMD and 6MWT improved significantly in the muscle stretching group vs. the control (FMD: 5.1 ± 0.5% vs. 3.7 ± 0.3%, P = 0.005; 6MWT continuous walking distance: 304 ± 43 m vs. 182 ± 34 m; P = 0.0006). No difference in nitroglycerin-induced dilation was found between groups (10.9 ± 1.2 vs. 9.9 ± 0.4%, P = 0.48). Post-stretching, 6MWT total walking distance was positively correlated with normalized FMD (R = 0.645, P = 0.02).
CONCLUSIONS


Passive calf muscle stretching enhanced vascular endothelial function and improved walking function in elderly patients with stable symptomatic PAD. These findings merit further investigation in a prospective randomized trial.",2019,"Post-stretching, 6MWT total walking distance was positively correlated with normalized FMD (R = 0.645, P = 0.02).
","['elderly patients with stable symptomatic PAD', 'PAD patients', 'Patients with peripheral arterial disease (PAD', 'aged rats', 'elderly patients with stable symptomatic peripheral artery disease', '13 patients with stable symptomatic PAD']","['Passive calf muscle stretching', 'Daily passive muscle stretching', 'passive calf muscle stretching (ankle dorsiflexion applied 30\u202fmin/d, 5\u202fdays/wk) followed by 4\u202fweeks of no muscle stretching and vice versa']","['normalized FMD', '6MWT total walking distance', 'Endothelium-dependent flow-mediated dilation (FMD) and endothelium-independent nitroglycerin-induced dilation of the popliteal artery and 6\u202fminute walk test (6MWT', 'muscle stretching, FMD and 6MWT', 'walking function', 'nitroglycerin-induced dilation', 'vascular endothelial function']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0034721', 'cui_str': 'Rats'}]","[{'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0014257', 'cui_str': 'Endothelium'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0032649', 'cui_str': 'Popliteal Artery'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0031843', 'cui_str': 'function'}]",13.0,0.14241,"Post-stretching, 6MWT total walking distance was positively correlated with normalized FMD (R = 0.645, P = 0.02).
","[{'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Hotta', 'Affiliation': 'Department of Biomedical Sciences, Florida State University College of Medicine, Tallahassee, FL, USA; Department of Physical Therapy, Niigata University of Health and Welfare, Niigata, Japan.'}, {'ForeName': 'Wayne B', 'Initials': 'WB', 'LastName': 'Batchelor', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, VA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Graven', 'Affiliation': 'Tallahassee Memorial Healthcare, Tallahassee, FL, USA.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Dahya', 'Affiliation': 'Summa Health Medical Group, Akron, OH, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Noel', 'Affiliation': 'Southern Medical Group, P.A., Tallahassee, FL, USA.'}, {'ForeName': 'Akash', 'Initials': 'A', 'LastName': 'Ghai', 'Affiliation': 'Southern Medical Group, P.A., Tallahassee, FL, USA.'}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Katopodis', 'Affiliation': 'Southern Medical Group, P.A., Tallahassee, FL, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Dixon', 'Affiliation': 'Southern Medical Group, P.A., Tallahassee, FL, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Andrews', 'Affiliation': 'Southern Medical Group, P.A., Tallahassee, FL, USA.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Pragle', 'Affiliation': 'Florida State University College of Medicine, Tallahassee, FL, USA.'}, {'ForeName': 'Jegghna', 'Initials': 'J', 'LastName': 'Chheda', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Florida State University College of Human Sciences, Tallahassee, FL, USA.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Liberatore', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Florida State University College of Human Sciences, Tallahassee, FL, USA.'}, {'ForeName': 'Brad J', 'Initials': 'BJ', 'LastName': 'Behnke', 'Affiliation': 'Department of Kinesiology, Kansas State University College of Human Ecology, Manhattan, KS, USA.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Muller-Delp', 'Affiliation': 'Department of Biomedical Sciences, Florida State University College of Medicine, Tallahassee, FL, USA. Electronic address: judy.delp@med.fsu.edu.'}]",Cardiovascular revascularization medicine : including molecular interventions,['10.1016/j.carrev.2019.05.003']
1056,30954567,Doxorubicin-loaded nanoparticles for patients with advanced hepatocellular carcinoma after sorafenib treatment failure (RELIVE): a phase 3 randomised controlled trial.,"BACKGROUND


Cytotoxic chemotherapy is generally ineffective in patients with hepatocellular carcinoma. We assessed the intravenous perfusion of doxorubicin-loaded nanoparticles in patients with hepatocellular carcinoma in whom previous sorafenib therapy had failed.
METHODS


We did a multicentre, open-label, randomised, controlled phase 3 trial at 70 sites in 11 countries. Patients with hepatocellular carcinoma with one or more previous systemic therapies, including sorafenib, were randomly assigned to receive 30 mg/m 2  doxorubicin-loaded nanoparticles (30 mg/m 2  group), 20 mg/m 2  doxorubicin-loaded nanoparticles (20 mg/m 2  group), or standard care using a computer-generated randomisation list prepared by the funder and stratified by geographic region. Patients in the experimental groups received perfusion of the drug every 4 weeks and those in the control group received any systemic anticancer therapy (except sorafenib) as per investigator decision. The primary endpoint was overall survival in the intention-to-treat population. Safety was assessed in the population of patients who received at least one dose of their assigned treatment. This trial is registered with ClinicalTrials.gov, number NCT01655693.
FINDINGS


Between June 15, 2012, and Jan 27, 2017, 541 patients were screened, of whom 144 were excluded and 397 were randomly assigned to one of the groups (133 to the 30 mg/m 2  group; 130 to the 20 mg/m 2  group; and 134 to the control group). Median follow-up was 22·7 months (IQR 11·2-34·9). After pooling the doxorubicin groups for the efficacy analysis, median overall survival was 9·1 months (95% CI 8·1-10·4) in the pooled doxorubicin-loaded nanoparticles group and 9·0 months (7·1-11·8) in the control group (HR 1·00 [95% CI 0·78-1·28], two-sided p=0·99). 227 (94%) of 242 patients who received doxorubicin-loaded nanoparticles and 100 (75%) of 134 patients in the control group had at least one treatment-emergent adverse event. The most common drug-related grade 3 or 4 treatment-emergent adverse events were neutropenia (25 [10%] of 242 treated with doxorubicin-loaded nanoparticles and eight [6%] of 134 in the control group), asthenia (six [2%] and four [3%]), and thrombocytopenia (three [1%] and ten [7%]). Six (2%) patients treated with doxorubicin-loaded nanoparticles and one (1%) of those in the control group were deemed by investigators to have had a drug-related death. Serious adverse events occurred in 74 (31%) patients who received doxorubicin-loaded nanoparticles and 48 (36%) in the control group.
INTERPRETATION


Doxorubicin-loaded nanoparticles did not improve overall survival for patients with hepatocellular carcinoma in whom previous sorafenib treatment had failed.
FUNDING


Onxeo.",2019,"INTERPRETATION


Doxorubicin-loaded nanoparticles did not improve overall survival for patients with hepatocellular carcinoma in whom previous sorafenib treatment had failed.
","['70 sites in 11 countries', 'Patients with hepatocellular carcinoma with one or more previous systemic therapies, including', 'patients with hepatocellular carcinoma in whom previous sorafenib treatment had failed', 'patients with hepatocellular carcinoma in whom previous sorafenib therapy had failed', 'patients with advanced hepatocellular carcinoma after sorafenib treatment failure (RELIVE', 'Between June 15, 2012, and Jan 27, 2017, 541 patients were screened, of whom 144 were excluded and 397', 'patients with hepatocellular carcinoma']","['Doxorubicin-loaded nanoparticles', 'doxorubicin-loaded nanoparticles', 'doxorubicin-loaded nanoparticles (30 mg/m 2  group), 20 mg/m 2  doxorubicin-loaded nanoparticles (20 mg/m 2  group), or standard care using a computer-generated randomisation list prepared by the funder and stratified by geographic region', 'doxorubicin', 'systemic anticancer therapy (except sorafenib', 'Cytotoxic chemotherapy', 'sorafenib']","['thrombocytopenia', 'neutropenia', 'asthenia', 'efficacy analysis, median overall survival', 'overall survival', 'Safety', 'Serious adverse events']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0162643'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C4521706', 'cui_str': 'Cytotoxic'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",541.0,0.142065,"INTERPRETATION


Doxorubicin-loaded nanoparticles did not improve overall survival for patients with hepatocellular carcinoma in whom previous sorafenib treatment had failed.
","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Merle', 'Affiliation': ""Service d'Hépatologie et Gastroentérologie, Hôpital de la Croix-Rousse, Lyon, France. Electronic address: philippe.merle@chu-lyon.fr.""}, {'ForeName': 'Jean-Frederic', 'Initials': 'JF', 'LastName': 'Blanc', 'Affiliation': 'Hôpital Haut Lévèque, Pessac, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Phelip', 'Affiliation': 'Centre Hospitalier Universitaire (CHU) de Saint-Étienne, Saint-Étienne, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Pelletier', 'Affiliation': 'Hôpital Paul Brousse, Villejuif, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Bronowicki', 'Affiliation': 'CHU de Nancy-Hôpital Brabois, Nancy, France.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Touchefeu', 'Affiliation': 'CHU Nantes-Hôpital Hôtel Dieu, Nantes, France.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Pageaux', 'Affiliation': 'CHU de Montpellier-Hôpital Saint-Eloi, Montpellier, France.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Gerolami', 'Affiliation': 'Hôpital de la Conception, Marseille, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Habersetzer', 'Affiliation': 'Centre Hospitalier Regional Universitaire de Strasbourg-Hôpital Civil, Strasbourg, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Nguyen-Khac', 'Affiliation': ""CHU d'Amiens, Hôpital Nord, Amiens, France.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Casadei-Gardini', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), IRCCS, Meldola, Italy.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Borbath', 'Affiliation': 'Université Catholique de Louvain Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Tran', 'Affiliation': 'CHU de Nice-Hôpital Archet, Nice, France.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Wege', 'Affiliation': 'Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Amr Shafik', 'Initials': 'AS', 'LastName': 'Saad', 'Affiliation': 'Department of Oncology, Ain Shams University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Colombo', 'Affiliation': ""Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda-Ospedale Maggiore Policlinico, Milano, Italy.""}, {'ForeName': 'Armand', 'Initials': 'A', 'LastName': 'Abergel', 'Affiliation': 'CHU de Clermont-Ferrand-Hôpital Estaing, Clermont-Ferrand, France.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Richou', 'Affiliation': 'CHU Jean Minjoz, Besançon, France.'}, {'ForeName': 'Imam', 'Initials': 'I', 'LastName': 'Waked', 'Affiliation': 'National Liver Institute, Menoufyia University, Menoufyia, Egypt.'}, {'ForeName': 'Nelson S', 'Initials': 'NS', 'LastName': 'Yee', 'Affiliation': 'Penn State Cancer Institute Milton S Hershey Medical Center, Hershey, PA, USA.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Molé', 'Affiliation': 'Onxeo, Paris, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Attali', 'Affiliation': 'Onxeo, Paris, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Le Boulicaut', 'Affiliation': 'eXYSTAT, Malakoff, France.'}, {'ForeName': 'Bérangère', 'Initials': 'B', 'LastName': 'Vasseur', 'Affiliation': 'Onxeo, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30040-8']
1057,32410641,Effect of acupuncture and its influence on cerebral activity in patients with persistent asthma: study protocol for a randomized controlled clinical trial.,"BACKGROUND


Previous studies suggested that acupuncture was a promising adjunctive treatment for asthma. However, the underlying mechanism of acupuncture for asthma remains unclear. The aim of the present trial is to explore whether and how specific meridian acupuncture works in quality of life and symptomatic improvement by modulating brain function in patients with asthma.
METHODS/DESIGN


This is a randomized controlled functional brain imaging trial currently being conducted in Sichuan, China. In total, 48 patients with mild to moderate persistent asthma will be recruited randomly and allocated to either of two acupuncture groups: acupuncture at the lung meridian or acupuncture at the heart meridian. The treatment period will last 4 weeks. The Asthma Quality of Life Questionnaire is the primary outcome. The Asthma Control Test, peak expiratory flow rate, forced expiratory volume in 1 s, Montreal Cognitive Assessment, Zung Self-rating Anxiety Scale, and Zung Self-rating Depression Scale will also be used to assess the clinical efficacy of different interventions. Functional magnetic resonance imaging (fMRI) will be performed to detect cerebral activity changes in each group. The clinical data and fMRI data will be analyzed between groups, then, the Pearson correlation analysis will be used to assess the association between the changes of cerebral activity features and the improvement of clinical outcomes in each group.
DISCUSSION


The present study has been established on the basis of the ""meridian-viscera relationship"" theory of traditional Chinese medicine and the modern central mechanism of acupuncture. The results of this trial would be useful to identify the efficiency of the specific meridian acupuncture for asthma. The investigation of its central mechanism would further expand knowledge of acupuncture for asthma.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1900027478. Registered on 15 November 2019.",2020,"The Asthma Control Test, peak expiratory flow rate, forced expiratory volume in 1 s, Montreal Cognitive Assessment, Zung Self-rating Anxiety Scale, and Zung Self-rating Depression Scale will also be used to assess the clinical efficacy of different interventions.","['patients with asthma', 'patients with persistent asthma', '48 patients with mild to moderate persistent asthma']","['acupuncture', 'Functional magnetic resonance imaging (fMRI', 'acupuncture at the lung meridian or acupuncture']","['Asthma Control Test, peak expiratory flow rate, forced expiratory volume in 1\u2009s, Montreal Cognitive Assessment, Zung Self-rating Anxiety Scale, and Zung Self-rating Depression Scale', 'Asthma Quality of Life Questionnaire', 'cerebral activity', 'cerebral activity changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0085282', 'cui_str': 'Jingluo'}]","[{'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C0030735', 'cui_str': 'Peak expiratory flow rate'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0451595', 'cui_str': ""Zung's self-rating anxiety scale""}, {'cui': 'C0451593', 'cui_str': 'Zung self-rating depression scale'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",48.0,0.161571,"The Asthma Control Test, peak expiratory flow rate, forced expiratory volume in 1 s, Montreal Cognitive Assessment, Zung Self-rating Anxiety Scale, and Zung Self-rating Depression Scale will also be used to assess the clinical efficacy of different interventions.","[{'ForeName': 'Siyi', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Brain Research Center, Acupuncture and Tuina School/Third Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37 Shierqiao Road, Chengdu, 610075, Sichuan, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'Brain Research Center, Acupuncture and Tuina School/Third Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37 Shierqiao Road, Chengdu, 610075, Sichuan, China.'}, {'ForeName': 'Ruirui', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'Brain Research Center, Acupuncture and Tuina School/Third Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37 Shierqiao Road, Chengdu, 610075, Sichuan, China.'}, {'ForeName': 'Zhaoxuan', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Brain Research Center, Acupuncture and Tuina School/Third Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37 Shierqiao Road, Chengdu, 610075, Sichuan, China.'}, {'ForeName': 'Chuantao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610072, Sichuan, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ""Fifth People's Hospital of Chengdu, Chengdu, 611130, Sichuan, China.""}, {'ForeName': 'Xiaojuan', 'Initials': 'X', 'LastName': 'Hong', 'Affiliation': 'Brain Research Center, Acupuncture and Tuina School/Third Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37 Shierqiao Road, Chengdu, 610075, Sichuan, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Lan', 'Affiliation': 'Brain Research Center, Acupuncture and Tuina School/Third Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37 Shierqiao Road, Chengdu, 610075, Sichuan, China. lanleicdutcm281@foxmail.com.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zeng', 'Affiliation': 'Brain Research Center, Acupuncture and Tuina School/Third Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37 Shierqiao Road, Chengdu, 610075, Sichuan, China. zeng_fang@cdutcm.edu.cn.'}]",Trials,['10.1186/s13063-020-04319-w']
1058,31068270,"Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial.","BACKGROUND


Bictegravir co-formulated with emtricitabine and tenofovir alafenamide as a fixed-dose combination is recommended for treatment of HIV-1-infection and might be better tolerated than other integrase inhibitor-based single-tablet regimens, but long-term outcomes data are not available. We assessed the efficacy, safety and tolerability of bictegravir, emtricitabine, and tenofovir alafenamide compared with co-formulated dolutegravir, abacavir, and lamivudine at week 96.
METHODS


This ongoing, randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial was done at 122 outpatient centres in nine countries. We enrolled adults (aged ≥18 years) living with HIV who were treatment naive and HLA-B*5701 negative, did not have hepatitis B virus infection, and had an estimated glomerular filtration rate of at least 50 mL/min. We randomly assigned participants (1:1) to receive co-formulated bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg (the bictegravir group) or co-formulated dolutegravir 50 mg, abacavir 600 mg, and lamivudine 300 mg (the dolutegravir group), each with matching placebo, once daily for 144 weeks. Treatment allocation was masked to all participants and investigators. All participants who received at least one dose of study drug were included in primary efficacy and safety analyses. We previously reported the primary endpoint. Here, we report the week 96 secondary outcome of proportion of participants with plasma HIV-1 RNA less than 50 copies per mL at week 96 by US Food and Drug Administration snapshot algorithm, with a prespecified non-inferiority margin of -12%. This study was registered with ClinicalTrials.gov, number NCT02607930.
FINDINGS


Between Nov 13, 2015, and July 14, 2016, we screened 739 participants, of whom 108 were excluded and 631 enrolled and randomly assigned to bictegravir, emtricitabine, and tenofovir alafenamide (n=316) or dolutegravir, abacavir, and lamivudine (n=315). Two participants in the bictegravir group did not receive at least one dose of their assigned drug and were excluded from analyses. At week 96, bictegravir, emtricitabine, and tenofovir alafenamide was non-inferior to dolutegravir, abacavir, and lamivudine, with 276 (88%) of 314 participants in the bictegravir group versus 283 (90%) of 315 participants in the dolutegravir group achieving HIV-1 RNA less than 50 copies per mL (difference -1·9%; 95% CI -6·9 to 3·1). The most common adverse events were nausea (36 [11%] of 314 for the bictegravir group vs 76 [24%] of 315 for the dolutegravir group), diarrhoea (48 [15%] vs 50 [16%]), and headache (41 [13%] vs 51 [16%]). 36 (11%) participants in the bictegravir group versus 39 (12%) participants in the dolutegravir group had a serious adverse event. Two individuals died in the bictegravir group (recreational drug overdose and suicide, neither of which was treatment related) and none died in the dolutegravir group. No participants discontinued because of adverse events in the bictegravir group compared with five (2%) of 315 in the dolutegravir group. Study drug-related adverse events were reported for 89 (28%) participants in the bictegravir group and 127 (40%) in the dolutegravir group.
INTERPRETATION


These week 96 data support bictegravir, emtricitabine, and tenofovir alafenamide as a safe, well tolerated, and durable treatment for people living with HIV-1 with no emergent resistance.
FUNDING


Gilead Sciences, Inc.",2019,No participants discontinued because of adverse events in the bictegravir group compared with five (2%) of 315 in the dolutegravir group.,"['HIV-1 infection', 'enrolled adults (aged ≥18 years) living with HIV who were treatment naive and HLA-B*5701 negative, did not have hepatitis B virus infection, and had an estimated glomerular filtration rate of at least 50 mL/min', 'people living with HIV-1 with no emergent resistance', 'Between Nov 13, 2015, and July 14, 2016, we screened 739 participants, of whom 108 were excluded and 631 enrolled and randomly assigned to', '122 outpatient centres in nine countries', 'n=315']","['Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine', 'dolutegravir group achieving HIV-1 RNA', 'bictegravir, emtricitabine, and tenofovir alafenamide (n=316) or dolutegravir, abacavir, and lamivudine', 'emtricitabine 200 mg, and tenofovir', 'emtricitabine and tenofovir alafenamide', 'bictegravir', 'bictegravir, emtricitabine, and tenofovir alafenamide compared with co-formulated dolutegravir, abacavir, and lamivudine', 'alafenamide 25 mg (the bictegravir group) or co-formulated dolutegravir 50 mg, abacavir 600 mg, and lamivudine 300 mg (the dolutegravir group), each with matching placebo']","['serious adverse event', 'efficacy, safety and tolerability', 'adverse events', 'headache', 'diarrhoea', 'proportion of participants with plasma HIV-1 RNA less', 'nausea']","[{'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0440557', 'cui_str': 'B*5701 (substance)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C3811844'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C4507568', 'cui_str': 'bictegravir'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4059167', 'cui_str': 'emtricitabine / tenofovir alafenamide'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0663655', 'cui_str': 'abacavir'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C1594209', 'cui_str': 'emtricitabine 200 MG [Emtriva]'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C3663830', 'cui_str': 'dolutegravir 50 MG'}, {'cui': 'C1629814', 'cui_str': 'abacavir 600 MG'}, {'cui': 'C1166421', 'cui_str': 'Lamivudine 300 MG'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",739.0,0.593634,No participants discontinued because of adverse events in the bictegravir group compared with five (2%) of 315 in the dolutegravir group.,"[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Wohl', 'Affiliation': 'Department of Medicine, Institute of Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Yazdan', 'Initials': 'Y', 'LastName': 'Yazdanpanah', 'Affiliation': 'Department of Medicine, Paris Diderot University, Paris, France.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Baumgarten', 'Affiliation': 'Zentrum für Infektiologie Berlin Prenzlauer Berg, Berlin, Germany.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Clarke', 'Affiliation': 'Claude Nicol Centre, Royal Sussex County Hospital, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Melanie A', 'Initials': 'MA', 'LastName': 'Thompson', 'Affiliation': 'AIDS Research Consortium of Atlanta, Atlanta, GA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Brinson', 'Affiliation': 'Central Texas Clinical Research, Austin, TX, USA.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Hagins', 'Affiliation': 'Georgia Department of Public Health, Coastal Health District, Chatham Care Center, Savannah, GA, USA.'}, {'ForeName': 'Moti N', 'Initials': 'MN', 'LastName': 'Ramgopal', 'Affiliation': 'Midway Immunology Center, Fort Pierce, FL, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Antinori', 'Affiliation': 'National Institute for Infectious Diseases Lazzaro Spallanzani-IRCCS, Roma, Italy.'}, {'ForeName': 'Xuelian', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Department of Biometrics, Gilead Sciences Inc, Foster City, CA, USA.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Acosta', 'Affiliation': 'Department of Virology, Gilead Sciences Inc, Foster City, CA, USA.'}, {'ForeName': 'Sean E', 'Initials': 'SE', 'LastName': 'Collins', 'Affiliation': 'Department of HIV Clinical Research, Gilead Sciences Inc, Foster City, CA, USA. Electronic address: sean.collins@gilead.com.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Brainard', 'Affiliation': 'Department of HIV Clinical Research, Gilead Sciences Inc, Foster City, CA, USA.'}, {'ForeName': 'Hal', 'Initials': 'H', 'LastName': 'Martin', 'Affiliation': 'Department of HIV Clinical Research, Gilead Sciences Inc, Foster City, CA, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(19)30077-3']
1059,31068272,"Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial.","BACKGROUND


The single-tablet regimen consisting of bictegravir, emtricitabine, and tenofovir alafenamide is recommended for treatment of HIV-1 infection on the basis of data from 48 weeks of treatment. Here, we examine the longer-term efficacy, safety, and tolerability of bictegravir, emtricitabine, and tenofovir alafenamide compared with dolutegravir plus co-formulated emtricitabine and tenofovir alafenamide at week 96.
METHODS


This ongoing, randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial was done at 126 outpatient centres in ten countries. We enrolled treatment-naive adults (aged ≥18 years) with HIV-1 infection who had an estimated glomerular filtration rate of at least 30 mL/min and sensitivity to emtricitabine and tenofovir. People with chronic hepatitis B or C infection, or both, and those who had used antivirals previously for prophylaxis were allowed. We randomly assigned participants (1:1) to receive treatment with either co-formulated bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg (the bictegravir group) or dolutegravir 50 mg with co-formulated emtricitabine 200 mg and tenofovir alafenamide 25 mg (the dolutegravir group), each with matching placebo, once daily for 144 weeks. Treatment allocation was masked to all participants and investigators. All participants who received at least one dose of study drug were included in primary efficacy and safety analyses. We previously reported the primary endpoint. Here, we report the week 96 secondary outcome of proportion of participants with plasma HIV-1 RNA less than 50 copies per mL at week 96 by US Food and Drug Administration snapshot algorithm, with a prespecified non-inferiority margin of -12%. This study was registered with ClinicalTrials.gov, number NCT02607956.
FINDINGS


Between Nov 13, 2015, and July 14, 2016, we screened 742 individuals, of whom 657 were enrolled. 327 participants were assigned to the bictegravir group and 330 to the dolutegravir group. Of these, 320 in the bictegravir group and 325 in the dolutegravir group received at least one dose of study drug. At week 96, HIV-1 RNA less than 50 copies per mL was achieved by 269 (84%) of 320 participants in the bictegravir group and 281 (86%) of 325 in the dolutegravir group (difference -2·3%, 95% CI -7·9 to 3·2), demonstrating non-inferiority of the bictegravir regimen compared with the dolutegravir regimen. Both treatments continued to be well tolerated through 96 weeks; 283 (88%) of 320 participants in the bictegravir group and 288 (89%) of 325 in the dolutegravir group had any adverse event and 55 (17%), and 33 (10%) had any serious adverse event. The most common adverse events were diarrhoea (57 [18%] of 320 in the bictegravir group vs 51 [16%] of 325 in the dolutegravir group) and headache (51 [16%] of 320 vs 48 [15%] of 325). Deaths were reported for three (1%) individuals in each group (one cardiac arrest, one gastric adenocarcinoma, and one hypertensive heart disease and congestive cardiac failure in the bictegravir group and one unknown causes, one pulmonary embolism, and one lymphoma in the dolutegravir group); none were considered to be treatment related. Adverse events led to discontinuation in six (2%) participants in the bictegravir group and five (2%) in the dolutegravir group; one of these events in the bictegravir group versus four in the dolutegravir group occurred between weeks 48 and 96. Study drug-related adverse events were reported for 64 (20%) participants in the bictegravir group and 92 (28%) in the dolutegravir group.
INTERPRETATION


These week 96 data support bictegravir, emtricitabine, and tenofovir alafenamide as a safe, well tolerated, and durable treatment for people living with chronic HIV.
FUNDING


Gilead Sciences, Inc.",2019,"Both treatments continued to be well tolerated through 96 weeks; 283 (88%) of 320 participants in the bictegravir group and 288 (89%) of 325 in the dolutegravir group had any adverse event and 55 (17%), and 33 (10%) had any serious adverse event.","['enrolled treatment-naive adults (aged ≥18 years) with HIV-1 infection who had an estimated glomerular filtration rate of at least 30 mL/min and sensitivity to', 'Between Nov 13, 2015, and July 14, 2016, we screened 742 individuals, of whom 657 were enrolled', 'HIV-1 infection', '126 outpatient centres in ten countries', '327 participants were assigned to the bictegravir group and 330 to the dolutegravir group', 'people living with chronic HIV', 'People with chronic hepatitis B or C infection, or both, and those who had used antivirals previously for prophylaxis were allowed']","['alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide', 'emtricitabine and tenofovir', 'co-formulated bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg (the bictegravir group) or dolutegravir 50 mg with co-formulated emtricitabine 200 mg and tenofovir alafenamide 25 mg (the dolutegravir group), each with matching placebo', 'Co-formulated bictegravir, emtricitabine, and tenofovir', 'dolutegravir plus co-formulated emtricitabine and tenofovir alafenamide', 'bictegravir', 'bictegravir, emtricitabine, and tenofovir alafenamide']","['hypertensive heart disease and congestive cardiac failure', 'serious adverse event', 'Deaths', 'adverse events', 'headache', 'diarrhoea', 'proportion of participants with plasma HIV-1 RNA less', 'longer-term efficacy, safety, and tolerability', 'adverse event']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}, {'cui': 'C3811844'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4507568', 'cui_str': 'bictegravir'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C1874329', 'cui_str': 'Antivirals, topical'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C4059167', 'cui_str': 'emtricitabine / tenofovir alafenamide'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C4551053', 'cui_str': 'bictegravir 50 MG'}, {'cui': 'C1594209', 'cui_str': 'emtricitabine 200 MG [Emtriva]'}, {'cui': 'C4293420', 'cui_str': 'tenofovir alafenamide 25 MG [Vemlidy]'}, {'cui': 'C4507568', 'cui_str': 'bictegravir'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3663830', 'cui_str': 'dolutegravir 50 MG'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}]","[{'cui': 'C0152105', 'cui_str': 'Hypertensive heart disease (disorder)'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",327.0,0.332056,"Both treatments continued to be well tolerated through 96 weeks; 283 (88%) of 320 participants in the bictegravir group and 288 (89%) of 325 in the dolutegravir group had any adverse event and 55 (17%), and 33 (10%) had any serious adverse event.","[{'ForeName': 'Hans-Jürgen', 'Initials': 'HJ', 'LastName': 'Stellbrink', 'Affiliation': 'Department of Internal Medicine, Infectious Diseases, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'José R', 'Initials': 'JR', 'LastName': 'Arribas', 'Affiliation': 'Department of HIV and Infectious Diseases, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Stephens', 'Affiliation': 'Department of Internal Medicine, Mercer University School of Medicine, Macon, GA, USA.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Albrecht', 'Affiliation': 'Department of Internal Medicine, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Sax', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Maggiolo', 'Affiliation': 'Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Creticos', 'Affiliation': 'Howard Brown Health Center, Chicago, IL, USA.'}, {'ForeName': 'Claudia T', 'Initials': 'CT', 'LastName': 'Martorell', 'Affiliation': 'Infectious Disease and The Research Institute, Springfield, MA, USA.'}, {'ForeName': 'Xuelian', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Department of Biometrics, Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Acosta', 'Affiliation': 'Department of Virology, Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Sean E', 'Initials': 'SE', 'LastName': 'Collins', 'Affiliation': 'Department of HIV Clinical Research, Gilead Sciences, Inc, Foster City, CA, USA. Electronic address: sean.collins@gilead.com.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Brainard', 'Affiliation': 'Department of HIV Clinical Research, Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Hal', 'Initials': 'H', 'LastName': 'Martin', 'Affiliation': 'Department of HIV Clinical Research, Gilead Sciences, Inc, Foster City, CA, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(19)30080-3']
1060,31133627,Water Pipe Smoking Reduction in the Male Adolescent Students: An Educational Intervention Using Multi-Theory Model.,"BACKGROUND


Water pipe smoking (WPS) has increased and is becoming a major leisure pastime among young people in Iran. The aim of this study was to determine of efficacy of an educational intervention based on Multi-Theory Model (MTM) to reduce WPS in the male adolescent students in Iran.
STUDY DESIGN


A randomized controlled trial.
METHODS


Overall, 94 male adolescent students (grades 10, 11) smoked water pipe (WP) in the past month (current WP smokers) were selected, allocated randomly in two groups (47 students in intervention group and 47 students in control group), in two different schools in 2018 in Hamadan City, western Iran. Data were collected utilizing a valid and reliable questionnaire based on MTM constructs and demographic variables. Educational intervention was designed in five 45-min sessions. Two groups were followed-up three-months after completion of intervention. The collected data were analyzed using SPSS 22 software through Chi-square test, independent-sample t-test, paired-samples t-test, and Friedman test.
RESULTS


There were significant differences between the mean score of participatory dialogue, behavioral confidence, emotional transformation and practice for change in the intervention group compared with the control group after the intervention (P<0.001). In addition, significant reductions in the frequency of WPS (from 14.9% to 4.3%) were observed in the intervention group compared to the control group (P<0.001).
CONCLUSION


The developed educational intervention based on MTM constructs was efficacious and can be replicated for effectiveness studies to reduce WPS in the male adolescent students in Iran.",2019,"There were significant differences between the mean score of participatory dialogue, behavioral confidence, emotional transformation and practice for change in the intervention group compared with the control group after the intervention (P<0.001).","['young people in Iran', 'male adolescent students in Iran', 'Male Adolescent Students', '94 male adolescent students (grades 10, 11) smoked water pipe (WP) in the past month (current WP smokers) were selected, allocated randomly in two groups (47 students in intervention group and 47 students in control group), in two different schools in 2018 in Hamadan City, western Iran']","['Educational intervention', 'educational intervention based on Multi-Theory Model (MTM', 'Water pipe smoking (WPS']","['frequency of WPS', 'mean score of participatory dialogue, behavioral confidence, emotional transformation and practice for change']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0071109', 'cui_str': ""piperazine-N,N'-bis(2-ethanesulfonic acid), sodium salt""}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C4505138', 'cui_str': 'Water Pipe Smoking'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C3714584', 'cui_str': 'Transformation, function (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",94.0,0.0455586,"There were significant differences between the mean score of participatory dialogue, behavioral confidence, emotional transformation and practice for change in the intervention group compared with the control group after the intervention (P<0.001).","[{'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Bashirian', 'Affiliation': 'Social Determinants of Health Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Barati', 'Affiliation': 'Social Determinants of Health Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Behavioral & Environmental Health, School of Public Health, Jackson State University, Jackson, MS, USA.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Abasi', 'Affiliation': 'Department of Public Health, School of Health, Hamadan University of Medical Sciences, Hamadan, Iran. hamid_mehdi29@yahoo.com.'}, {'ForeName': 'Manoochehr', 'Initials': 'M', 'LastName': 'Karami', 'Affiliation': 'Research Center for Health Sciences, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Journal of research in health sciences,[]
1061,30470466,The Effect of Foot Massage on Postoperative Pain and Anxiety Levels in Laparoscopic Cholecystectomy Surgery: A Randomized Controlled Experimental Study.,"PURPOSE


This study determined the effect of foot massage on postoperative pain and anxiety levels in patients undergoing laparoscopic cholecystectomy surgery.
DESIGN


A randomized controlled trial.
METHODS


This study was conducted in a general surgery clinic of a university hospital between May 2016 and March 2018. The research sample consisted of 167 patients (85 in the experimental group and 82 in the control group) who met the research inclusion criteria.
FINDINGS


The pain intensity of patients in the experimental group was less than in the control group at 30, 60, 90, and 120 minutes after intervention (P < .05). A significant reduction was determined in the need for analgesics for the patients in the experimental group compared with the control group (P < .05). A significant positive relationship was found between pain intensity and state anxiety levels in patients of the experimental group.
CONCLUSIONS


Foot massage decreased postoperative pain and anxiety levels in patients undergoing laparoscopic cholecystectomy surgery.",2019,A significant reduction was determined in the need for analgesics for the patients in the experimental group compared with the control group (P < .05).,"['167 patients (85 in the experimental group and 82 in the control group) who met the research inclusion criteria', 'patients undergoing laparoscopic cholecystectomy surgery', 'general surgery clinic of a university hospital between May 2016 and March 2018', 'Laparoscopic Cholecystectomy Surgery']","['Foot massage', 'Foot Massage', 'foot massage']","['pain intensity and state anxiety levels', 'need for analgesics', 'Postoperative Pain and Anxiety Levels', 'postoperative pain and anxiety levels', 'pain intensity']","[{'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035168'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3840262', 'cui_str': 'General surgery clinic'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",,0.0679828,A significant reduction was determined in the need for analgesics for the patients in the experimental group compared with the control group (P < .05).,"[{'ForeName': 'Kezban', 'Initials': 'K', 'LastName': 'Koraş', 'Affiliation': ''}, {'ForeName': 'Neziha', 'Initials': 'N', 'LastName': 'Karabulut', 'Affiliation': ''}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2018.07.006']
1062,31748939,A Latent Class Analysis of HIV Risk Factors Among Men and Women with Opioid Use Disorder in Pre-trial Detention.,"Adults entering pre-trial detention who inject drugs are at high risk for acquiring HIV/AIDS. In the current study, we examined pre-incarceration HIV risk behaviors among 114 people with opioid use disorder who inject drugs. Participants were recruited from the Baltimore City Detention Center as part of a randomized controlled trial of pre-release methadone treatment. Using latent class analysis, we found three separate latent classes, which we identified as the sex exchange class (14.2%), drug equipment sharing class (36.8%) and lower risk class (49.0%). Women in the sex exchange class (n = 16) reported having multiple male partners and selling sex for money or drugs; however, this group also reported more consistent condom use and less frequent injection drug and equipment sharing than participants in the drug equipment sharing class. Our findings highlight distinct profiles of jail detainees with OUD based on their risks for HIV, and could inform more targeted interventions for each group.Clinical Trials Registration: Clinicaltrials.gov NCT02334215.",2020,"Women in the sex exchange class (n = 16) reported having multiple male partners and selling sex for money or drugs; however, this group also reported more consistent condom use and less frequent injection drug and equipment sharing than participants in the drug equipment sharing class.","['Adults entering pre-trial detention who inject drugs are at high risk for acquiring HIV/AIDS', '114 people with opioid use disorder who inject drugs', 'Men and Women with Opioid Use Disorder in Pre-trial Detention', 'Participants were recruited from the Baltimore City Detention Center as part of a randomized controlled trial of pre-release']",['methadone treatment'],['HIV Risk Factors'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",114.0,0.105735,"Women in the sex exchange class (n = 16) reported having multiple male partners and selling sex for money or drugs; however, this group also reported more consistent condom use and less frequent injection drug and equipment sharing than participants in the drug equipment sharing class.","[{'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute, 1040 Park Ave, Suite 103, Baltimore, MD, 21201, USA. mmitchell@friendsresearch.org.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gryczynski', 'Affiliation': 'Friends Research Institute, 1040 Park Ave, Suite 103, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Shannon G', 'Initials': 'SG', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute, 1040 Park Ave, Suite 103, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Kelly', 'Affiliation': 'Friends Research Institute, 1040 Park Ave, Suite 103, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': ""O'Grady"", 'Affiliation': 'Friends Research Institute, 1040 Park Ave, Suite 103, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Monico', 'Affiliation': 'Friends Research Institute, 1040 Park Ave, Suite 103, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Schwartz', 'Affiliation': 'Friends Research Institute, 1040 Park Ave, Suite 103, Baltimore, MD, 21201, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02726-y']
1063,31748836,Conservative oxygen therapy for mechanically ventilated adults with sepsis: a post hoc analysis of data from the intensive care unit randomized trial comparing two approaches to oxygen therapy (ICU-ROX).,"PURPOSE


Sepsis is a common reason for intensive care unit (ICU) admission and mortality in ICU patients. Despite increasing interest in treatment strategies limiting oxygen exposure in ICU patients, no trials have compared conservative vs. usual oxygen in patients with sepsis.
METHODS


We undertook a post hoc analysis of the 251 patients with sepsis enrolled in a trial that compared conservative oxygen therapy with usual oxygen therapy in 1000 mechanically ventilated ICU patients. The primary end point for the current analysis was 90-day mortality. Key secondary outcomes were cause-specific mortality, ICU and hospital length of stay, ventilator-free days, vasopressor-free days, and the proportion of patients receiving renal replacement therapy in the ICU.
RESULTS


Patients with sepsis allocated to conservative oxygen therapy spent less time in the ICU with an SpO 2  ≥ 97% (23.5 h [interquartile range (IQR) 8-70] vs. 47 h [IQR 11-93], absolute difference, 23 h; 95% CI 8-38), and more time receiving an FiO 2  of 0.21 than patients allocated to usual oxygen therapy (20.5 h [IQR 1-79] vs. 0 h [IQR 0-10], absolute difference, 20 h; 95% CI 14-26). At 90-days, 47 of 130 patients (36.2%) assigned to conservative oxygen and 35 of 120 patients (29.2%) assigned to usual oxygen had died (absolute difference, 7 percentage points; 95% CI - 4.6 to 18.6% points; P = 0.24; interaction P = 0.35 for sepsis vs. non-sepsis). There were no statistically significant differences between groups for secondary outcomes but point estimates of treatment effects consistently favored usual oxygen therapy.
CONCLUSIONS


Point estimates for the treatment effect of conservative oxygen therapy on 90-day mortality raise the possibility of clinically important harm with this intervention in patients with sepsis; however, our post hoc analysis was not powered to detect the effects suggested and our data do not exclude clinically important benefit or harm from conservative oxygen therapy in this patient group.
CLINICAL TRIALS REGISTRY


ICU-ROX Australian and New Zealand Clinical Trials Registry number ACTRN12615000957594.",2020,"At 90-days, 47 of 130 patients (36.2%) assigned to conservative oxygen and 35 of 120 patients (29.2%) assigned to usual oxygen had died (absolute difference, 7 percentage points; 95% CI - 4.6 to 18.6% points; P = 0.24; interaction P = 0.35 for sepsis vs. non-sepsis).","['patients with sepsis', 'Patients with sepsis allocated to', 'ICU patients', 'mechanically ventilated adults with sepsis', '251 patients with sepsis enrolled in a trial that compared', '1000 mechanically ventilated ICU patients']","['oxygen therapy (ICU-ROX', 'conservative oxygen therapy', 'usual oxygen therapy', 'Conservative oxygen therapy', 'conservative oxygen therapy with usual oxygen therapy']","['cause-specific mortality, ICU and hospital length of stay, ventilator-free days, vasopressor-free days, and the proportion of patients receiving renal replacement therapy in the ICU', '90-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}]",1000.0,0.413117,"At 90-days, 47 of 130 patients (36.2%) assigned to conservative oxygen and 35 of 120 patients (29.2%) assigned to usual oxygen had died (absolute difference, 7 percentage points; 95% CI - 4.6 to 18.6% points; P = 0.24; interaction P = 0.35 for sepsis vs. non-sepsis).","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand. paul.young@ccdhb.org.nz.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Mackle', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Deane', 'Affiliation': 'University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Eastwood', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Finfer', 'Affiliation': 'Division of Critical Care and Trauma, The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Freebairn', 'Affiliation': 'Intensive Care Unit, Hawkes Bay Hospital, Hastings, New Zealand.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'King', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Linke', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, WA, Australia.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Rakshit', 'Initials': 'R', 'LastName': 'Panwar', 'Affiliation': 'Intensive Care Unit, John Hunter Hospital, New Lambton Heights, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-019-05857-x']
1064,31141424,"Acute Effects of Hip Mobilization With Movement Technique on Pain and Biomechanics in Females With Patellofemoral Pain: A Randomized, Placebo-Controlled Trial.","CONTEXT


People with patellofemoral pain (PFP) present altered lower-limb movements during some activities. Perhaps, joint misalignment in the hip is one of the reasons for altered movement patterns in people with PFP. Some mobilization techniques have been designed to address joint misalignments.
OBJECTIVE


To investigate the acute effects of hip mobilization with movement (MWM) technique on pain and biomechanics during squats and jumps in females with and without PFP.
DESIGN


Randomized, placebo-controlled trial.
SETTING


Movement analysis laboratory.
PATIENTS


Fifty-six physically active females (28 with PFP and 28 asymptomatic) were divided into 4 groups: experimental group with PFP, sham group with PFP, experimental group without PFP, and sham group without PFP.
INTERVENTION(S)


The experimental groups received MWM for the hip, and the sham groups received sham mobilization.
MAIN OUTCOME MEASURES


Pain, trunk, and lower-limb kinematics, and hip and knee kinetics during single-leg squats and landings.
RESULTS


After the interventions, no difference between groups was found for pain. The PFP experimental group decreased hip internal rotation during squats compared with the PFP sham group (P = .03). There was no other significant difference between PFP groups for kinematic or kinetic outcomes during squats, as well as for any outcome during landings. There was no difference between asymptomatic groups for any of the outcomes in any of the tasks.
CONCLUSIONS


Hip mobilization was ineffective to reduce pain in people with PFP. Hip MWM may contribute to dynamic lower-limb realignment in females with PFP by decreasing hip internal rotation during squats. Therefore, hip MWM could be potentially useful as a complementary intervention for patients with PFP.",2019,The PFP experimental group decreased hip internal rotation during squats compared to the PFP sham group (p=0.03).,"['Females With Patellofemoral Pain', 'patients with PFP', 'people with PFP', 'People with patellofemoral pain (PFP', 'Fifty-six physically active females (28 with PFP and 28 asymptomatic) divided into four groups', 'pain and biomechanics during squats and jumps in females with and without PFP']","['placebo', 'PFP experimental and sham, and asymptomatic experimental and sham', 'Hip Mobilization With Movement Technique', 'Placebo', 'MWM', 'hip mobilization-with-movement (MWM) technique', 'Hip mobilization', 'sham mobilization']","['Pain and Biomechanics', 'hip internal rotation', 'Pain, trunk and lower limb kinematics, and hip and knee kinetics during single-leg squats and landings', 'pain']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0231459', 'cui_str': 'Medial rotation - action (qualifier value)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0557668', 'cui_str': 'Landing (environment)'}]",56.0,0.177057,The PFP experimental group decreased hip internal rotation during squats compared to the PFP sham group (p=0.03).,"[{'ForeName': 'Guilherme S', 'Initials': 'GS', 'LastName': 'Nunes', 'Affiliation': ''}, {'ForeName': 'Débora Faria', 'Initials': 'DF', 'LastName': 'Wolf', 'Affiliation': ''}, {'ForeName': 'Daniel Augusto', 'Initials': 'DA', 'LastName': 'Dos Santos', 'Affiliation': ''}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'de Noronha', 'Affiliation': ''}, {'ForeName': 'Fábio Viadanna', 'Initials': 'FV', 'LastName': 'Serrão', 'Affiliation': ''}]",Journal of sport rehabilitation,['10.1123/jsr.2018-0497']
1065,31117088,"Enarodustat, Conversion and Maintenance Therapy for Anemia in Hemodialysis Patients: A Randomized, Placebo-Controlled Phase 2b Trial Followed by Long-Term Trial.","BACKGROUND


Enarodustat (JTZ-951) is an orally available hypoxia-inducible factor prolyl hydroxylase inhibitor that increases endogenous erythropoietin levels in the treatment of anemia associated with chronic kidney disease (CKD).
OBJECTIVE


A phase 2b study of enarodustat to assess the hemoglobin (Hb) response, safety, and maintenance dosage was conducted in Japanese anemic patients with hemodialysis-dependent CKD.
METHODS


Subjects receiving a stable dose of an erythropoiesis-stimulating agent were randomized to receive once-daily enarodustat at a dose of 2, 4, or 6 mg or placebo in a double-blind manner for 6 weeks (Period 1) followed by 24-week open treatment with enarodustat, adjusted in the range of 2-8 mg to maintain Hb within a target range (10.0-12.0 g/dL; Period 2).
RESULTS


Change in Hb from baseline increased with enarodustat dose in Period 1. In Period 2, the proportion of subjects who maintained their Hb level within the target range at the end of treatment was 65.1%. To maintain Hb levels within the target range over the course of Period 2, approximately 80% of subjects required 2 dose adjustments or fewer. Enarodustat decreased hepcidin and ferritin levels, increased total iron-binding capacity, and was generally well tolerated.
CONCLUSIONS


Enarodustat corrected and maintained Hb levels in anemic patients with hemodialysis-dependent CKD. Phase 3 studies of enarodustat are currently ongoing.",2019,"Enarodustat decreased hepcidin and ferritin levels, increased total iron-binding capacity, and was generally well tolerated.
","['Subjects receiving a stable dose of an erythropoiesis-stimulating agent', 'anemic patients with hemodialysis-dependent CKD', 'Anemia in Hemodialysis Patients', 'anemia associated with chronic kidney disease (CKD', 'Japanese anemic patients with hemodialysis-dependent CKD']","['Placebo', 'Enarodustat (JTZ-951', 'placebo']","['hepcidin and ferritin levels', 'tolerated', 'total iron-binding capacity', 'hemoglobin (Hb) response, safety', 'endogenous erythropoietin levels']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1959590', 'cui_str': 'Erythropoiesis Stimulating Agents'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0966897', 'cui_str': 'Liver-Expressed Antimicrobial Peptide'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0202001', 'cui_str': 'Erythropoietin measurement (procedure)'}]",,0.0666146,"Enarodustat decreased hepcidin and ferritin levels, increased total iron-binding capacity, and was generally well tolerated.
","[{'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Akizawa', 'Affiliation': 'Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan, akizawa@med.showa-u.ac.jp.'}, {'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Nangaku', 'Affiliation': 'Division of Nephrology and Endocrinology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Biostatistics, Tohoku University Graduate School of Medicine, Miyagi, Japan.'}, {'ForeName': 'Masanobu', 'Initials': 'M', 'LastName': 'Arai', 'Affiliation': 'Pharmaceutical Division, Japan Tobacco Inc., Tokyo, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Koretomo', 'Affiliation': 'Pharmaceutical Division, Japan Tobacco Inc., Tokyo, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Maeda', 'Affiliation': 'Pharmaceutical Division, Japan Tobacco Inc., Tokyo, Japan.'}, {'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Miyazawa', 'Affiliation': 'Pharmaceutical Division, Japan Tobacco Inc., Tokyo, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Hirakata', 'Affiliation': 'Fukuoka Renal Clinic, Fukuoka, Japan.'}]",Nephron,['10.1159/000500487']
1066,30132262,Effect of metformin on blood pressure in patients with hypertension: a randomized clinical trial.,"OBJECTIVE


Part of the beneficial effects of metformin on the prevention of cardiovascular events in diabetes can be attributed to pleiotropic effects, including a blood pressure (BP)-lowering effect. In a double-blind parallel clinical trial (NCT02072382), the effect of metformin on BP evaluated by ambulatory blood pressure monitoring (ABPM) was measured.
METHODS


Ninety-seven patients with hypertension, but without diabetes mellitus, were randomized to receive 850-1700 mg of metformin (n = 48) or placebo (n = 49). Clinical, laboratory, and ABPM data were collected at the baseline and after 8 weeks of follow-up.
RESULTS


The sample consisted mainly of White overweight women. There was no difference in BP reduction measured by ABPM between both groups. There was no effect in BP measured in the different periods of ABP monitoring and office BP. Additionally, fasting plasma glucose, lipids, and C-reactive protein remained unchanged during the trial. There was a significant reduction in waist circumference with metformin (95.1 ± 10.4 to 89.3 ± 27.4 cm; p = 0.02).
CONCLUSION


In the present trial, metformin did not reduce BP, measured by ABP monitoring, in hypertensive patients without diabetes.",2019,There was no difference in BP reduction measured by ABPM between both groups.,"['hypertensive patients without diabetes', 'Ninety-seven patients with hypertension, but without diabetes mellitus', 'patients with hypertension', 'White overweight women']","['850-1700\u2009mg of metformin', 'placebo', 'metformin']","['blood pressure', 'waist circumference', 'fasting plasma glucose, lipids, and C-reactive protein', 'BP reduction', 'BP evaluated by ambulatory blood pressure monitoring (ABPM', 'BP', 'Clinical, laboratory, and ABPM data']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C3840657', 'cui_str': '850 (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0242876', 'cui_str': 'Blood Pressure Monitoring, Ambulatory'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]",97.0,0.148384,There was no difference in BP reduction measured by ABPM between both groups.,"[{'ForeName': 'Vicente Corrêa', 'Initials': 'VC', 'LastName': 'Júnior', 'Affiliation': 'Postgraduate Program in Medicine: Cardiology, School of Medicine, Universidade Federal do Rio Grande do Sul, Rio Grande do Sul, Brazil. vicentecorreajunior@terra.com.br.'}, {'ForeName': 'Flávio Danni', 'Initials': 'FD', 'LastName': 'Fuchs', 'Affiliation': 'Division of Cardiology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Beatriz D', 'Initials': 'BD', 'LastName': 'Schaan', 'Affiliation': 'Postgraduate Program in Medicine: Endocrinology, School of Medicine, Universidade Federal do Rio Grande do Sul, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Leila Beltrami', 'Initials': 'LB', 'LastName': 'Moreira', 'Affiliation': 'Postgraduate Program in Medicine: Cardiology, School of Medicine, Universidade Federal do Rio Grande do Sul, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Sandra Costa', 'Initials': 'SC', 'LastName': 'Fuchs', 'Affiliation': 'Postgraduate Program in Medicine: Cardiology, School of Medicine, Universidade Federal do Rio Grande do Sul, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Gus', 'Affiliation': 'Division of Cardiology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}]",Endocrine,['10.1007/s12020-018-1722-1']
1067,31119849,The therapeutic relationship in Cognitive Behaviour Therapy with depressed adolescents: A qualitative study of good-outcome cases.,"OBJECTIVES


This paper aimed to explore client experiences of the therapeutic relationship among adolescents with good outcomes after receiving Cognitive Behaviour Therapy (CBT) for moderate to severe depression.
DESIGN


This was a qualitative study employing Interpretative Phenomenological Analysis (IPA).
METHODS


As part of a randomized clinical trial, 77 adolescents with moderate to severe depression were interviewed using a semi-structured interview, which was audio-recorded. Five of these interviews, with adolescents aged 14-18 years who completed CBT and had good outcomes, were purposively sampled and analysed using IPA.
RESULTS


The findings indicated that a positive therapeutic relationship was fostered with therapists who respected the adolescents' autonomy and sense of individuality, while offering experiences of emotional closeness and connection. This was achieved by balancing the dual roles of being 'friendly' and affable, with being a 'professional expert' thereby embodying a collaborative and egalitarian approach.
CONCLUSIONS


The therapeutic relationship in CBT can help to motivate adolescents to engage with cognitively and emotionally challenging tasks. By providing an understanding of what helps and hinders the development of a positive therapeutic relationship, the current findings offer important insight into how therapists can foster positive relationships with depressed adolescents. This knowledge will make it more likely that adolescents will engage in the treatment process and in turn experience greater therapeutic gains.
PRACTITIONER POINTS


Offers a detailed phenomenological analysis of what fostered a positive therapeutic relationship in good outcome CBT, and what was experienced as harmful from the adolescents' perspective. Provides support that the therapeutic relationship is crucial in CBT; a respectful and understanding relationship provides a platform for the adolescent to carry out CBT activities and tasks.",2020,"The findings indicated that a positive therapeutic relationship was fostered with therapists who respected the adolescents' autonomy and sense of individuality, while offering experiences of emotional closeness and connection.","['adolescents aged 14-18\xa0years who completed CBT and had good outcomes', '77 adolescents with moderate to severe depression', 'depressed adolescents', 'adolescents with good outcomes after receiving']","['CBT', 'Cognitive Behaviour Therapy', 'Cognitive Behaviour Therapy (CBT']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]",[],77.0,0.0309412,"The findings indicated that a positive therapeutic relationship was fostered with therapists who respected the adolescents' autonomy and sense of individuality, while offering experiences of emotional closeness and connection.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Wilmots', 'Affiliation': 'UCL and the Anna Freud National Centre for Children and Families, London, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Midgley', 'Affiliation': 'Child Attachment and Psychological Therapies Research Unit (ChAPTRe), UCL and the Anna Freud National Centre for Children and Families, London, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Thackeray', 'Affiliation': 'UCL and the Anna Freud National Centre for Children and Families, London, UK.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Reynolds', 'Affiliation': 'Charlie Waller Institute, School of Psychology and Clinical Language Sciences, University of Reading, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Loades', 'Affiliation': 'Department of Psychology, University of Bath, UK.'}]",Psychology and psychotherapy,['10.1111/papt.12232']
1068,30413359,"Single-Blinded Randomized Controlled Study on Use of Interactive Distraction Versus Oral Midazolam to Reduce Pediatric Preoperative Anxiety, Emergence Delirium, and Postanesthesia Length of Stay.","PURPOSE


The purpose of this study was to compare effects of tablet-based interactive distraction (TBID; 1 minute preseparation) with oral midazolam (15 to 45 minutes of preseparation) on preoperative anxiety, emergence delirium, and postanesthesia length of stay in children, 4 to 12 years undergoing outpatient surgery.
DESIGN


Single-blinded prospective design with randomized assignment to TBID or oral midazolam group was conducted at a large pediatric hospital in southwestern United States.
METHODS


A total of 102 children and caregivers were enrolled. Outcome measures included anxiety scores at baseline, separation, and mask induction; postemergence delirium scores; caregiver ratings of child anxiety and satisfaction; and time from postanesthesia care unit arrival to discharge and posthospital behaviors.
FINDINGS


The TBID group demonstrated significantly lower anxiety at separation and mask induction (P < .001) and emergence delirium at 15 minutes postawakening (P = .001), were extubated earlier (P = .007), arrived to phase II earlier (P = .03), and discharged earlier (P = .0001).
CONCLUSIONS


TBID was more effective than oral midazolam in reducing preoperative anxiety, emergence delirium, and postanesthesia length of stay.",2019,"The TBID group demonstrated significantly lower anxiety at separation and mask induction (P < .001) and emergence delirium at 15 minutes postawakening (P = .001), were extubated earlier (P = .007), arrived to phase II earlier (P = .03), and discharged earlier (P = .0001).
","['children, 4 to 12\xa0years undergoing outpatient surgery', 'group was conducted at a large pediatric hospital in southwestern United States', '102 children and caregivers were enrolled']","['tablet-based interactive distraction (TBID', 'Interactive Distraction Versus Oral Midazolam', 'oral midazolam', 'midazolam']","['lower anxiety at separation and mask induction', 'emergence delirium', 'preoperative anxiety, emergence delirium, and postanesthesia length of stay', 'anxiety scores at baseline, separation, and mask induction; postemergence delirium scores; caregiver ratings of child anxiety and satisfaction; and time from postanesthesia care unit arrival to discharge and posthospital behaviors', 'Pediatric Preoperative Anxiety, Emergence Delirium, and Postanesthesia Length of Stay']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]","[{'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C0412768', 'cui_str': 'Inhalational induction (procedure)'}, {'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care (regime/therapy)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]",102.0,0.0635377,"The TBID group demonstrated significantly lower anxiety at separation and mask induction (P < .001) and emergence delirium at 15 minutes postawakening (P = .001), were extubated earlier (P = .007), arrived to phase II earlier (P = .03), and discharged earlier (P = .0001).
","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Stewart', 'Affiliation': ''}, {'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Cazzell', 'Affiliation': ''}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Pearcy', 'Affiliation': ''}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2018.08.004']
1069,31145885,"Timing of postpartum etonogestrel-releasing implant insertion and bleeding patterns, weight change, 12-month continuation and satisfaction rates: a randomized controlled trial.","OBJECTIVES


To evaluate whether timing of etonogestrel (ENG) implant insertion during the postpartum period affects maternal bleeding patterns, body mass index (BMI) and 12-month satisfaction and continuation rates.
STUDY DESIGN


This is a secondary analysis of an open, randomized, controlled trial. Postpartum women were block-randomized to early (up to 48 h postpartum) or delayed (6 weeks postpartum) insertion of an ENG implant. Bleeding patterns and BMI were evaluated every 90 days for 12 months. At 12 months, we measured implant continuation rates and used Likert and face scales to measure users' satisfaction. The level of significance was 0.4% (adjusted by Bonferroni test for multiplicity).
RESULTS


We enrolled 100 postpartum women; we randomized 50 to early and 50 to delayed postpartum ENG implant insertion. Bleeding patterns were similar between groups. Amenorrhea rates were high in both groups during the follow-up (52%-56% and 46%-62% in the early and delayed insertion group, respectively). Prolonged bleeding episodes were unusual in both groups during the follow-up (0-2%). Maternal BMI was similar between groups and decreased over time. Twelve-month continuation rates were similar between groups (early insertion: 98% vs. delayed insertion: 100%, p=.99). Most participants were either very satisfied or satisfied with the ENG implant in both groups (p=.9).
CONCLUSION


Women who underwent immediate postpartum insertion of the ENG implant have similar bleeding patterns, BMI changes, and 12-month satisfaction and continuation rates compared to those who underwent delayed insertion.
IMPLICATIONS


Our results from a secondary analysis of a clinical trial support that satisfaction, continuation and bleeding patterns do not differ when women received contraceptive implants immediately postpartum or at 6 weeks. However, the emphasis on infant growth in the trial and easy access to delayed placement may have influenced results.",2019,"Twelve-month continuation rates were similar between groups (early insertion: 98% vs. delayed insertion: 100%, p=.99).",['We enrolled 100 postpartum women'],"['delayed postpartum ENG implant insertion', 'postpartum etonogestrel-releasing implant insertion', 'etonogestrel (ENG) implant insertion']","[""implant continuation rates and used Likert and face scales to measure users' satisfaction"", 'bleeding patterns, weight change, 12-month continuation and satisfaction rates', 'Amenorrhea rates', 'Maternal BMI', 'satisfaction, continuation and bleeding patterns', 'bleeding patterns, BMI changes, and 12-month satisfaction and continuation rates', 'Prolonged bleeding episodes', 'maternal bleeding patterns, body mass index (BMI) and 12-month satisfaction and continuation rates', 'Bleeding patterns and BMI', 'Bleeding patterns']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0047683', 'cui_str': 'Etonogestrel'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0222045'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",100.0,0.239124,"Twelve-month continuation rates were similar between groups (early insertion: 98% vs. delayed insertion: 100%, p=.99).","[{'ForeName': 'Carolina Sales', 'Initials': 'CS', 'LastName': 'Vieira', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical School of Ribeirao Preto, University of São Paulo, Brazil. Avenida Bandeirantes, 3900 Campus Universitário Monte Alegre, CEP: 14049-900, Ribeirão Preto, SP, Brazil. Electronic address: carol.sales@uol.com.br.'}, {'ForeName': 'Mariane Nunes', 'Initials': 'MN', 'LastName': 'de Nadai', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical School of Ribeirao Preto, University of São Paulo, Brazil. Avenida Bandeirantes, 3900 Campus Universitário Monte Alegre, CEP: 14049-900, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Lilian Sheila', 'Initials': 'LS', 'LastName': 'de Melo Pereira do Carmo', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical School of Ribeirao Preto, University of São Paulo, Brazil. Avenida Bandeirantes, 3900 Campus Universitário Monte Alegre, CEP: 14049-900, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Giordana Campos', 'Initials': 'GC', 'LastName': 'Braga', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical School of Ribeirao Preto, University of São Paulo, Brazil. Avenida Bandeirantes, 3900 Campus Universitário Monte Alegre, CEP: 14049-900, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Bruna Fregonesi', 'Initials': 'BF', 'LastName': 'Infante', 'Affiliation': ""Women' s Health Reference Center of Ribeirão Preto. Avenida Wanderley Taffo, 330 Quintino Facci II, CEP: 14070-000, Ribeirão Preto, SP, Brazil.""}, {'ForeName': 'Bianca M', 'Initials': 'BM', 'LastName': 'Stifani', 'Affiliation': ""Department of Obstetrics, Gynecology and Women's Health of Albert Einstein College of Medicine / Montefiore Medical Center, 1300 Morris Park Avenue, Bronx, NY, 10461, USA.""}, {'ForeName': 'Rui Alberto', 'Initials': 'RA', 'LastName': 'Ferriani', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical School of Ribeirao Preto, University of São Paulo, Brazil. Avenida Bandeirantes, 3900 Campus Universitário Monte Alegre, CEP: 14049-900, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Silvana Maria', 'Initials': 'SM', 'LastName': 'Quintana', 'Affiliation': ""Department of Gynecology and Obstetrics, Medical School of Ribeirao Preto, University of São Paulo, Brazil. Avenida Bandeirantes, 3900 Campus Universitário Monte Alegre, CEP: 14049-900, Ribeirão Preto, SP, Brazil; Women' s Health Reference Center of Ribeirão Preto. Avenida Wanderley Taffo, 330 Quintino Facci II, CEP: 14070-000, Ribeirão Preto, SP, Brazil.""}]",Contraception,['10.1016/j.contraception.2019.05.007']
1070,31129929,Biomarker guidance allows a more personalized allocation of patients for remote patient management in heart failure: results from the TIM-HF2 trial.,"AIMS


The TIM-HF2 study showed less days lost due to unplanned cardiovascular hospitalization or all-cause death and improved survival in patients randomly assigned to remote patient management (RPM) instead of standard of care.
METHODS AND RESULTS


This substudy explored whether the biomarkers mid-regional pro-adrenomedullin (MR-proADM) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) could be used to identify low-risk patients unlikely to benefit from RPM, thereby allowing more efficient allocation of the intervention. For 1538 patients of the trial (median age 73 years, interquartile range 64-78 years, 30% female), baseline biomarkers were used to select subpopulations recommended for RPM with various safety endpoints (100%, 98%, 95% sensitivity), and efficacy of RPM was assessed. Both biomarkers were strongly associated with events. The primary endpoint of lost days increased from 1.0% (1.4%) in the lowest to 17.3% (17.6%) in the highest quintile of NT-proBNP (MR-proADM). After combining biomarkers to identify patients recommended for RPM with 95% sensitivity, in the most efficient scenario (excluding 27% of patients; NT-proBNP < 413.7 pg/mL and MR-proADM < 0.75 nmol/L), the effect of RPM on patients was highly similar to the original trial (ratio of lost days: 0.78, hazard ratio for all-cause death: 0.68). Number needed to treat for all-cause death was lowered from 28 to 21. Rates of emergencies and telemedical efforts were significantly lower among patients not recommended for RPM. Biomarker guidance would have saved about 150 h effort/year per 100 patients of the eligible population.
CONCLUSIONS


The combined use of MR-proADM and NT-proBNP may allow safe, more precise, effective and cost-saving allocation of patients with heart failure to RPM and warrants further prospective studies.",2019,Rates of emergencies and telemedical efforts were significantly lower among patients not recommended for RPM.,"['1538 patients of the trial (median age 73\u2009years, interquartile range 64-78\u2009years, 30% female', 'patients for remote patient management in heart failure', 'patients with heart failure to RPM']","['biomarkers mid-regional pro-adrenomedullin (MR-proADM) and N-terminal pro-B-type natriuretic peptide (NT-proBNP', 'MR-proADM and NT-proBNP']","['efficacy of RPM', 'Rates of emergencies and telemedical efforts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0582523', 'cui_str': 'rpm'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0215825', 'cui_str': 'Adrenomedullin (1-52)'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}]","[{'cui': 'C0582523', 'cui_str': 'rpm'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}]",,0.110128,Rates of emergencies and telemedical efforts were significantly lower among patients not recommended for RPM.,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Möckel', 'Affiliation': 'Division of Emergency and Acute Medicine, Cardiovascular Process Research, Campus Mitte and Virchow, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Koehler', 'Affiliation': 'Centre for Cardiovascular Telemedicine, Department of Cardiology and Angiology, Campus Mitte, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK) and Berlin Institute of Health, Center for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) partner site Berlin Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Jörn', 'Initials': 'J', 'LastName': 'Vollert', 'Affiliation': 'Clinical Diagnostics, Thermo Fisher Scientific, Hennigsdorf, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Moeller', 'Affiliation': 'Centre for Cardiovascular Telemedicine, Department of Cardiology and Angiology, Campus Mitte, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Koehler', 'Affiliation': 'Technical University Munich, Department of Prevention, Rehabilitation and Sports Medicine, Ludwig-Maximilians-Universität, Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Gehrig', 'Affiliation': 'Clinical Diagnostics, Thermo Fisher Scientific, Hennigsdorf, Germany.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Wiemer', 'Affiliation': 'Clinical Diagnostics, Thermo Fisher Scientific, Hennigsdorf, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'von Haehling', 'Affiliation': 'Department of Cardiology and Pneumology, Universitätsmedizin Göttingen, Göttingen, Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Koehler', 'Affiliation': 'Centre for Cardiovascular Telemedicine, Department of Cardiology and Angiology, Campus Mitte, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}]",European journal of heart failure,['10.1002/ejhf.1530']
1071,28082323,Second Generation Electronic Nicotine Delivery System Vape Pen Exposure Generalizes as a Smoking Cue.,"Introduction


Second generation electronic nicotine delivery systems (ENDS; also known as e-cigarettes, vaporizers or vape pens) are designed for a customized nicotine delivery experience and have less resemblance to regular cigarettes than first generation ""cigalikes."" The present study examined whether they generalize as a conditioned cue and evoke smoking urges or behavior in persons exposed to their use.
Methods


Data were analyzed in N = 108 young adult smokers (≥5 cigarettes per week) randomized to either a traditional combustible cigarette smoking cue or a second generation ENDS vaping cue in a controlled laboratory setting. Cigarette and e-cigarette urge and desire were assessed pre- and post-cue exposure. Smoking behavior was also explored in a subsample undergoing a smoking latency phase after cue exposure (N = 26).
Results


The ENDS vape pen cue evoked both urge and desire for a regular cigarette to a similar extent as that produced by the combustible cigarette cue. Both cues produced similar time to initiate smoking during the smoking latency phase. The ENDS vape pen cue elicited smoking urge and desire regardless of ENDS use history, that is, across ENDS naїve, lifetime or current users. Inclusion of past ENDS or cigarette use as covariates did not significantly alter the results.
Conclusions


These findings demonstrate that observation of vape pen ENDS use generalizes as a conditioned cue to produce smoking urge, desire, and behavior in young adult smokers. As the popularity of these devices may eventually overtake those of first generation ENDS cigalikes, exposure effects will be of increasing importance.
Implications


This study shows that passive exposure to a second generation ENDS vape pen cue evoked smoking urge, desire, and behavior across a range of daily and non-daily young adult smokers. Smoking urge and desire increases after vape pen exposure were similar to those produced by exposure to a first generation ENDS cigalike and a combustible cigarette, a known potent cue. Given the increasing popularity of ENDS tank system products, passive exposures to these devices will no doubt increase, and may contribute to tobacco use in young adult smokers.",2018,"Smoking urge and desire increases after vape pen exposure were similar to those produced by exposure to a first generation ENDS cigalike and a combustible cigarette, a known potent cue.","['young adult smokers', 'subsample undergoing a smoking latency phase after cue exposure (N = 26', '108 young adult smokers (≥5 cigarettes per week) randomized to either a']","['Introduction\n\n\nSecond generation electronic nicotine delivery systems (ENDS', 'traditional combustible cigarette smoking cue or a second generation ENDS vaping cue']","['Cigarette and e-cigarette urge and desire', 'Smoking behavior']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C1293116', 'cui_str': 'Introduction'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C4083280', 'cui_str': 'Vaping'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C1519383', 'cui_str': 'Smoking Behaviors'}]",108.0,0.00981272,"Smoking urge and desire increases after vape pen exposure were similar to those produced by exposure to a first generation ENDS cigalike and a combustible cigarette, a known potent cue.","[{'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'King', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago IL.'}, {'ForeName': 'Lia J', 'Initials': 'LJ', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago IL.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McNamara', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago IL.'}, {'ForeName': 'Dingcai', 'Initials': 'D', 'LastName': 'Cao', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago IL.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntw327']
1072,31748169,Long-term effects of intensive multifactorial therapy in individuals with screen-detected type 2 diabetes in primary care: 10-year follow-up of the ADDITION-Europe cluster-randomised trial.,"BACKGROUND


The multicentre, international ADDITION-Europe study investigated the effect of promoting intensive treatment of multiple risk factors among people with screen-detected type 2 diabetes over 5 years. Here we report the results of a post-hoc 10-year follow-up analysis of ADDITION-Europe to establish whether differences in treatment and cardiovascular risk factors have been maintained and to assess effects on cardiovascular outcomes.
METHODS


As previously described, general practices from four centres (Denmark, Cambridge [UK], Leicester [UK], and the Netherlands) were randomly assigned by computer-generated list to provide screening followed by routine care of diabetes, or screening followed by intensive multifactorial treatment. Population-based stepwise screening programmes among people aged 40-69 years (50-69 years in the Netherlands), between April, 2001, and December, 2006, identified patients with type 2 diabetes. Allocation was concealed from patients. Following the 5-year follow-up, no attempts were made to maintain differences in treatment between study groups. In this report, we did a post-hoc analysis of cardiovascular and renal outcomes over 10 years following randomisation, including a 5 years post-intervention follow-up. As in the original trial, the primary endpoint was a composite of first cardiovascular event, including cardiovascular mortality, cardiovascular morbidity (non-fatal myocardial infarction and non-fatal stroke), revascularisation, and non-traumatic amputation, up to Dec 31, 2014. Analyses were based on the intention-to-treat principle. ADDITION-Europe is registered with ClinicalTrials.gov, NCT00237549.
FINDINGS


343 general practices were randomly assigned to routine diabetes care (n=176) or intensive multifactorial treatment (n=167). 317 of these general practices (157 in the routine care group, 161 in the intensive treatment group) included eligible patients between April, 2001, and December, 2006. Of the 3233 individuals with screen-detected diabetes, 3057 agreed to participate (1379 in the routine care group, 1678 in the intensive treatment group), but at the 10-year follow-up 14 were lost to follow-up and 12 withdrew, leaving 3031 to enter 10-year follow-up analysis. Mean duration of follow-up was 9·61 years (SD 2·99). Sustained reductions over 10 years following diagnosis were apparent for bodyweight, HbA 1c , blood pressure, and cholesterol in both study groups, but between-group differences identified at 1 and 5 years were attenuated at the 10-year follow-up. By 10 years, 443 participants had a first cardiovascular event and 465 died. There was no significant difference between groups in the incidence of the primary composite outcome (16·1 per 1000 person-years in the routine care group vs 14·3 per 1000 person-years in the intensive treatment group; hazard ratio [HR] 0·87, 95% CI 0·73-1·04; p=0·14) or all-cause mortality (15·6 vs 14·3 per 1000 person-years; HR 0·90, 0·76-1·07).
INTERPRETATION


Sustained reductions in glycaemia and related cardiovascular risk factors over 10 years among people with screen-detected diabetes managed in primary care are achievable. The differences in prescribed treatment and cardiovascular risk factors in the 5 years following diagnosis were not maintained at 10 years, and the difference in cardiovascular events and mortality remained non-significant.
FUNDING


National Health Service Denmark, Danish Council for Strategic Research, Danish Research Foundation for General Practice, Novo Nordisk, Novo Nordisk Foundation, Danish Centre for Evaluation and Health Technology Assessment, Danish National Board of Health, Danish Medical Research Council, Aarhus University Research Foundation, Astra, Pfizer, GlaxoSmithKline, Servier, HemoCue, Wellcome Trust, UK Medical Research Council, UK National Institute for Health Research, UK National Health Service, Merck, Julius Center for Health Sciences and Primary Care, UK Department of Health, and Nuts-OHRA.",2019,"Sustained reductions over 10 years following diagnosis were apparent for bodyweight, HbA 1c , blood pressure, and cholesterol in both study groups, but between-group differences identified at 1 and 5 years were attenuated at the 10-year follow-up.","['people aged 40-69 years (50-69 years in the Netherlands), between April, 2001, and December, 2006, identified patients with type 2 diabetes', 'people with screen-detected type 2 diabetes over 5 years', '343 general practices', 'individuals with screen-detected type 2 diabetes in primary care', '3233 individuals with screen-detected diabetes, 3057 agreed to participate (1379 in the routine care group, 1678 in the intensive treatment group), but at the 10-year follow-up 14 were lost to follow-up and 12 withdrew, leaving 3031 to enter 10-year follow-up analysis', '443 participants had a first cardiovascular event and 465 died', 'As previously described, general practices from four centres (Denmark, Cambridge [UK], Leicester [UK], and the Netherlands', '317 of these general practices (157 in the routine care group, 161 in the intensive treatment group) included eligible patients between April, 2001, and December, 2006']","['routine diabetes care (n=176) or intensive multifactorial treatment', 'computer-generated list to provide screening followed by routine care of diabetes, or screening followed by intensive multifactorial treatment', 'intensive multifactorial therapy']","['Mean duration', 'cardiovascular risk factors', 'bodyweight, HbA 1c , blood pressure, and cholesterol', 'cardiovascular events and mortality', 'composite of first cardiovascular event, including cardiovascular mortality, cardiovascular morbidity (non-fatal myocardial infarction and non-fatal stroke), revascularisation, and non-traumatic amputation']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1269815', 'cui_str': 'Patient identification'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0002694', 'cui_str': 'Amputation, Traumatic'}]",443.0,0.0983433,"Sustained reductions over 10 years following diagnosis were apparent for bodyweight, HbA 1c , blood pressure, and cholesterol in both study groups, but between-group differences identified at 1 and 5 years were attenuated at the 10-year follow-up.","[{'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Primary Care Unit, Institute of Public Health, School of Clinical Medicine, University of Cambridge, Cambridge, UK. Electronic address: profgp@medschl.cam.ac.uk.'}, {'ForeName': 'Guy E H M', 'Initials': 'GEHM', 'LastName': 'Rutten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Witte', 'Affiliation': 'Section of Epidemiology, Aarhus University, Aarhus, Denmark; Department of Public Health, Aarhus University, Aarhus, Denmark; Danish Diabetes Academy, Odense, Denmark.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Lauritzen', 'Affiliation': 'Section for General Practice, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Sharp', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Else-Marie', 'Initials': 'EM', 'LastName': 'Dalsgaard', 'Affiliation': 'Section for General Practice, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'Greg J', 'Initials': 'GJ', 'LastName': 'Irving', 'Affiliation': 'Primary Care Unit, Institute of Public Health, School of Clinical Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Rimke C', 'Initials': 'RC', 'LastName': 'Vos', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht University, Utrecht, Netherlands; Department of Public Health and Primary Care, Leiden University Medical Center, Campus The Hague, The Hague, Netherlands.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Webb', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Wareham', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Annelli', 'Initials': 'A', 'LastName': 'Sandbæk', 'Affiliation': 'Section for General Practice, Aarhus University, Aarhus, Denmark; Steno Diabetes Center, Aarhus University Hospital, Aarhus, Denmark.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30349-3']
1073,31911641,Comparison of extubation success using noninvasive positive pressure ventilation (NIPPV) versus noninvasive neurally adjusted ventilatory assist (NI-NAVA).,"OBJECTIVE


Compare rates of initial extubation success in preterm infants extubated to NIPPV or NI-NAVA.
STUDY DESIGN


In this pilot study, we randomized 30 mechanically ventilated preterm infants at the time of initial elective extubation to NI-NAVA or NIPPV in a 1:1 assignment. Primary study outcome was initial extubation success.
RESULTS


Rates of continuous extubation for 120 h were 92% in the NI-NAVA group and 69% in the NIPPV group (12/13 vs. 9/13, respectively, p = 0.14). Infants extubated to NI-NAVA remained extubated longer (median 18 vs. 4 days, p = 0.02) and experienced lower peak inspiratory pressures (PIP) than infants managed with NIPPV throughout the first 3 days after extubation. Survival analysis through 14 days post extubation showed a sustained difference in the primary study outcome until 12 days post extubation.
CONCLUSIONS


Our study is the first to suggest that a strategy of extubating preterm infants to NI-NAVA may be more successful.",2020,"Survival analysis through 14 days post extubation showed a sustained difference in the primary study outcome until 12 days post extubation.
","['30 mechanically ventilated preterm infants at the time of initial elective extubation to NI-NAVA or NIPPV in a 1:1 assignment', 'preterm infants extubated to NIPPV or NI-NAVA']",['noninvasive positive pressure ventilation (NIPPV) versus noninvasive neurally adjusted ventilatory assist (NI-NAVA'],"['peak inspiratory pressures (PIP', 'initial extubation success', 'Rates of continuous extubation', 'Infants extubated to NI-NAVA remained extubated longer']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}]","[{'cui': 'C3164735', 'cui_str': 'Noninvasive positive pressure ventilation (procedure)'}, {'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}]","[{'cui': 'C0232021', 'cui_str': 'Maximum inspiratory pressure (observable entity)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",30.0,0.203056,"Survival analysis through 14 days post extubation showed a sustained difference in the primary study outcome until 12 days post extubation.
","[{'ForeName': 'Kartikeya', 'Initials': 'K', 'LastName': 'Makker', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA. kmakker@gmail.com.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Cortez', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.'}, {'ForeName': 'Kanishk', 'Initials': 'K', 'LastName': 'Jha', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.'}, {'ForeName': 'Sanket', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.'}, {'ForeName': 'Padma', 'Initials': 'P', 'LastName': 'Nandula', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lowrie', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Smotherman', 'Affiliation': 'Center for Health Equity and Research (CHEQR), University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Gautam', 'Affiliation': 'Center for Health Equity and Research (CHEQR), University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Hudak', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0578-4']
1074,31532482,Challenges and opportunities using online portals to recruit diverse patients to behavioral trials.,"We describe the use of an online patient portal to recruit and enroll primary care patients in a randomized trial testing the effectiveness of a colorectal cancer (CRC) screening decision support program. We use multiple logistic regression to identify patient characteristics associated with trial recruitment, enrollment, and engagement. We found that compared to Whites, Blacks had lower odds of viewing the portal message (OR = 0.46, 95% CI = 0.37-0.57), opening the attached link containing the study material (OR = 0.75, 95% CI = 0.62-0.92), and consenting to participate in the trial (OR = 0.85, 95% CI = 0.67-0.93). We also found that compared to Whites, Asians had lower odds of viewing the portal message (OR = 0.53, 95% CI = 0.33-0.64), opening the attached link containing the study material (OR = 0.76, 95% CI = 0.54-0.97), consenting to participate in the trial (OR = 0.68, 95% CI = 0.53-0.95), and completing the trial's baseline questionnaire (OR = 0.59, 95% CI = 0.36-0.90). While portals offer an opportunity to mitigate human bias in trial invitations, because of racial disparities-not only in who has a portal account, but in how they interact with trial recruitment and enrollment material within the portal-using portals alone for trial recruitment may generate study samples that are not racially diverse.",2019,"We found that compared to Whites, Blacks had lower odds of viewing the portal message (OR = 0.46, 95% CI = 0.37-0.57), opening the attached link containing the study material (OR = 0.75, 95% CI = 0.62-0.92), and consenting to participate in the trial (OR = 0.85, 95% CI = 0.67-0.93).",[],['colorectal cancer (CRC) screening decision support program'],['viewing the portal message'],[],"[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}]",,0.136261,"We found that compared to Whites, Blacks had lower odds of viewing the portal message (OR = 0.46, 95% CI = 0.37-0.57), opening the attached link containing the study material (OR = 0.75, 95% CI = 0.62-0.92), and consenting to participate in the trial (OR = 0.85, 95% CI = 0.67-0.93).","[{'ForeName': 'Amir Alishahi', 'Initials': 'AA', 'LastName': 'Tabriz', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Patrice Jordan', 'Initials': 'PJ', 'LastName': 'Fleming', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Yongyun', 'Initials': 'Y', 'LastName': 'Shin', 'Affiliation': 'Department of Biostatistics, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Health Behavior & Health Education, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Resa M', 'Initials': 'RM', 'LastName': 'Jones', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Public Health and Fox Chase Cancer Center, Temple University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Flocke', 'Affiliation': 'Department of Family Medicine, Oregon Health Sciences University, Portland, Oregon, USA.'}, {'ForeName': 'Deirdre A', 'Initials': 'DA', 'LastName': 'Shires', 'Affiliation': 'School of Social Work, Michigan State University, East Lansing, Michigan, USA.'}, {'ForeName': 'Sarah T', 'Initials': 'ST', 'LastName': 'Hawley', 'Affiliation': 'Department of Medicine, Center for Health Communications Research, University of Michigan and Ann Arbor VA Center for Clinical Management Research, Ann Arbor, Michigan, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Willens', 'Affiliation': 'Henry Ford Health System, Detroit, Michigan, USA.'}, {'ForeName': 'Jennifer Elston', 'Initials': 'JE', 'LastName': 'Lafata', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocz157']
1075,31702415,Participant-level characteristics differ by recruitment setting when evaluating a behavioral intervention targeting adolescents with asthma.,"Objective:  The recruitment setting plays a key role in the evaluation of behavioral interventions. We evaluated a behavioral intervention for urban adolescents with asthma in three randomized trials conducted separately in three different settings over the course of 8 years. We hypothesized that characteristics of trial participants recruited from the ED and clinic settings would be significantly different from that of youth participating in the school-based trials. The intervention evaluated was Puff City, a web-based program that uses tailoring to improve asthma management behaviors. Methods:  The present analysis includes youth aged 13-19 years who reported a physician diagnosis of asthma and symptoms at trial baseline. In the three trials, all participants were randomized post-baseline to a web-based, tailored intervention (treatment) or generic web-based asthma education (control). Results:  Compared to school-based trial participants, ED participants had significantly more acute-care visits for asthma ( p  < 0.001) and more caregiver depression ( p  < 0.001). Clinic-based participants were more likely to have computer/ internet access than participants from the school-based trial ( p  < 0.001). Both ED and clinic participants were more likely to report controller medication ( p 's < 0.001) and higher teen emotional support ( p 's < 0.01) when compared to the schools, but were less likely to report Medicaid ( p 's < 0.014) and exposure to environmental tobacco smoke ( p  < 0.001). Conclusion:  Compared to participants in the school-based trials, participants recruited from ED and clinic settings differed significantly in terms of healthcare use, as well as psychosocial and sociodemographic factors. These factors can inform intervention content, and may impact external validity of behavioral interventions for asthma.",2019,"Both ED and clinic participants were more likely to report controller medication (p's < 0.001) and higher teen emotional support (p's < 0.01) when compared to the schools, but were less likely to report Medicaid (p's < 0.014) and exposure to environmental tobacco smoke (p < 0.001).Compared to participants in the school-based trials, participants recruited from ED and clinic settings differed significantly in terms of healthcare use, as well as psychosocial and sociodemographic factors.","['targeting adolescents with asthma', 'urban adolescents with asthma in three randomized trials conducted separately in three different settings over the course of 8 years', 'youth aged 13-19 years who reported a physician diagnosis of asthma and symptoms at trial baseline']","['behavioral intervention', 'tailored intervention (treatment) or generic web-based asthma education (control']","['higher teen emotional support', 'acute-care visits for asthma', 'environmental tobacco smoke', 'caregiver depression']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1679754', 'cui_str': 'Asthma education (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0600015', 'cui_str': 'Emotional support (regime/therapy)'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for (contextual qualifier) (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke (substance)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",,0.133058,"Both ED and clinic participants were more likely to report controller medication (p's < 0.001) and higher teen emotional support (p's < 0.01) when compared to the schools, but were less likely to report Medicaid (p's < 0.014) and exposure to environmental tobacco smoke (p < 0.001).Compared to participants in the school-based trials, participants recruited from ED and clinic settings differed significantly in terms of healthcare use, as well as psychosocial and sociodemographic factors.","[{'ForeName': 'Christine L M', 'Initials': 'CLM', 'LastName': 'Joseph', 'Affiliation': 'Department of Public Health Sciences, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Mahajan', 'Affiliation': 'Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Buzzelli-Stokes', 'Affiliation': 'Department of Emergency Medicine, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Jacobsen', 'Affiliation': 'Department of Public Health Sciences, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Dayna A', 'Initials': 'DA', 'LastName': 'Johnson', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Duffy', 'Affiliation': 'Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'Department of Public Health Sciences, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Havstad', 'Affiliation': 'Department of Public Health Sciences, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Zoratti', 'Affiliation': 'Division of Allergy and Immunology, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Dennis R', 'Initials': 'DR', 'LastName': 'Ownby', 'Affiliation': 'Department of Pediatrics, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Christine Cole', 'Initials': 'CC', 'LastName': 'Johnson', 'Affiliation': 'Department of Public Health Sciences, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'Department of Public Health Sciences, Henry Ford Health System, Detroit, MI, USA.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2019.1690661']
1076,31096099,High versus low mean arterial pressures in hepatorenal syndrome: A randomized controlled pilot trial.,"There is controversy regarding the mean arterial pressure (MAP) goals that should be targeted in the treatment of hepatorenal syndrome (HRS.) We conducted a study to assess different MAP targets in HRS in the intensive care unit (ICU).
MATERIALS AND METHODS


This is a prospective randomized controlled pilot trial. ICU patients had target mean arterial pressure (MAP) ≥ 85 mmHg (control arm) or 65-70 mmHg (study arm). Urine output and serum creatinine were trended and recorded.
RESULTS


A total of 18 patients were enrolled. The day four urine output in the high and low MAP group was 1194 (SD = 1249) mL/24 h and 920 (SD = 812) mL/24 h, respectively. The difference in day four - day one urine output was -689 (SD = 1684) mL/24 h and 272 (SD = 582) mL/24 h for the high and low MAP groups. The difference in serum creatinine at day four - day one was -0.54 (SD = 0.63) mg/dL and - 0.77 (SD = 1.14) mg/dL in the high and low MAP groups, respectively.
CONCLUSION


In this study, we failed to prove non-inferiority between a low and high target MAP in patients with HRS.
TRIAL REGISTRATION


This trial was registered with and approved by the University of Louisville Internal Review Board and hospital research review committees (IRB # 14.1190). The trial was registered with ClinicalTrials.gov (ID # NCT02789150). The IRB committee roster 7/21/2014-2/26/2015 is registered with IORG (IORG # IORG0000147; OMB # 0990-0279) and is available at http://louisville.edu/research/humansubjects/about-the-irb/rosters/RosterEffective20140721thru20150226.pdf.",2019,The difference in serum creatinine at day four - day one was -0.54,"['ICU patients had target mean arterial pressure (MAP)\u202f≥\u202f85\u202fmmHg (control arm) or 65-70\u202fmmHg (study arm', '18 patients were enrolled', 'hepatorenal syndrome', 'patients with HRS']",[],"['serum creatinine', 'Urine output and serum creatinine', 'mean arterial pressure (MAP) goals']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0019212', 'cui_str': 'Hepatorenal Syndrome'}]",[],"[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C1287298', 'cui_str': 'UO - Urine output'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018017', 'cui_str': 'Goals'}]",18.0,0.265903,The difference in serum creatinine at day four - day one was -0.54,"[{'ForeName': 'Benadin', 'Initials': 'B', 'LastName': 'Varajic', 'Affiliation': 'Department of Internal Medicine, University of Louisville, USA. Electronic address: b0vara01@louisville.edu.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Cavallazzi', 'Affiliation': 'Department of Pulmonary, Critical Care, and Sleep Disorders Medicine, University of Louisville, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Mann', 'Affiliation': 'Department of Pulmonary, Critical Care, and Sleep Disorders Medicine, University of Louisville, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Furmanek', 'Affiliation': 'Department of Infectious Disease, University of Louisville, USA.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Guardiola', 'Affiliation': 'Department of Pulmonary, Critical Care, and Sleep Disorders Medicine, University of Louisville, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Saad', 'Affiliation': 'Department of Pulmonary, Critical Care, and Sleep Disorders Medicine, University of Louisville, USA.'}]",Journal of critical care,['10.1016/j.jcrc.2019.04.006']
1077,30920584,Comparison of intra-procedural vs. post-stenting prolonged bivalirudin infusion for residual thrombus burden in patients with ST-segment elevation myocardial infarction undergoing: the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) OCT study.,"AIMS


To compare prolonged bivalirudin infusion vs. an intra-procedural only bivalirudin infusion administration in subjects with ST-segment elevation myocardial infarction (STEMI) regarding residual stent strut thrombosis.
METHODS AND RESULTS


Multivessel STEMI patients undergoing primary percutaneous coronary intervention (PPCI) and scheduled for a staged percutaneous coronary intervention (PCI) before hospital discharge were selected among those allocated to either prolonged bivalirudin or intra-procedural only bivalirudin infusion in the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) Treatment-Duration study. Optical coherence tomography (OCT) of the infarct-related artery was performed at the end of PPCI and 4-5 days thereafter during staged intervention. The predefined endpoint was the percentage difference in the number of stent cross-sections with a thrombotic area >5% at the end of PPCI and at the time of staged PCI (ΔThCS). Between September 2013 and November 2015, 137 were randomized to either intra-procedural only bivalirudin infusion (N = 64) or prolonged bivalirudin (N = 73) at 16 European sites. Mean stent area, minimum lumen area, percentage of malapposed struts, and mean percent thrombotic area were comparable after index or staged PCI. The difference in the proportion of frames with percent thrombotic area >5% (ΔTh > 5%) were -7.7 (-22.1 to 5.1) in the intra-procedural bivalirudin infusion group and -8.8 (-23.1 to 2.6) in the prolonged infusion group (P = 0.994). Time from index to follow-up OCT imaging and the infarct vessel artery did not affect this OCT-based endpoint.
CONCLUSION


A strategy of prolonged bivalirudin infusion after PPCI did not reduce residual stent strut thrombosis when compared with intra-procedural only bivalirudin infusion administration (funded by The Medicines Company and Terumo; MATRIX ClinicalTrials.gov number, NCT01433627).",2019,"A strategy of prolonged bivalirudin infusion after PPCI did not reduce residual stent strut thrombosis when compared with intra-procedural only bivalirudin infusion administration (funded by The Medicines Company and Terumo; MATRIX ClinicalTrials.gov number, NCT01433627).","['Between September 2013 and November 2015, 137 were randomized to either', 'Multivessel STEMI patients undergoing primary percutaneous coronary intervention (PPCI) and scheduled for a staged percutaneous coronary intervention (PCI) before hospital discharge', 'subjects with ST-segment elevation myocardial infarction (STEMI) regarding residual stent strut thrombosis', 'patients with ST-segment elevation myocardial infarction undergoing']","['bivalirudin or intra-procedural only bivalirudin infusion in the MATRIX', 'intra-procedural only bivalirudin infusion (N\u2009=\u200964) or prolonged bivalirudin', 'intra-procedural vs. post-stenting prolonged bivalirudin infusion', 'bivalirudin infusion administration', 'bivalirudin']","['Mean stent area, minimum lumen area, percentage of malapposed struts, and mean percent thrombotic area', 'residual stent strut thrombosis', 'number of stent cross-sections with a thrombotic area', 'Optical coherence tomography (OCT', 'proportion of frames with percent thrombotic area']","[{'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}]","[{'cui': 'C0168273', 'cui_str': 'bivalirudin'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0449958', 'cui_str': 'Number of stent(s) (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}]",,0.121127,"A strategy of prolonged bivalirudin infusion after PPCI did not reduce residual stent strut thrombosis when compared with intra-procedural only bivalirudin infusion administration (funded by The Medicines Company and Terumo; MATRIX ClinicalTrials.gov number, NCT01433627).","[{'ForeName': 'Hector M', 'Initials': 'HM', 'LastName': 'Garcia-Garcia', 'Affiliation': 'MedStar Washington Hospital Center, Washington, DC, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Picchi', 'Affiliation': 'Misericordia Hospital, Grosseto, Italy.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Sardella', 'Affiliation': 'Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Adamo', 'Affiliation': 'Azienda Ospedaliera Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Frigoli', 'Affiliation': 'Clinical Trials Unit, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Limbruno', 'Affiliation': 'Misericordia Hospital, Grosseto, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Rigattieri', 'Affiliation': 'Sandro Pertini Hospital, Rome, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Diletti', 'Affiliation': 'Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Boccuzzi', 'Affiliation': 'San Giovanni Bosco Hospital, Turin, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Zimarino', 'Affiliation': 'Università degli Studi ""G. d\'Annunzio"" Chieti e Pescara, Chieti, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Contarini', 'Affiliation': 'Ospedale Umberto I, Siracusa, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Russo', 'Affiliation': ""Azienda Ospedaliera Sant'Anna, Como, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': ""Calabro'"", 'Affiliation': 'Division of Cardiology, Department of Cardiothoracic and Respiratory Sciences, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Andò', 'Affiliation': 'Azienda Ospedaliera Universitaria G. Martino, Messina, Italy.'}, {'ForeName': 'Ferdinando', 'Initials': 'F', 'LastName': 'Varbella', 'Affiliation': 'Cardiology Unit, Ospedali Riuniti di Rivoli, ASL Torino 3, Turin, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Garducci', 'Affiliation': ""Unita' Operativa Complessa di Cardiologia ASST di Vimercate (MB), Vimercate, Italy.""}, {'ForeName': 'Cataldo', 'Initials': 'C', 'LastName': 'Palmieri', 'Affiliation': 'Institute of Clinical Physiology, C.N.R./G. Monasterio Foundation, Massa, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Briguori', 'Affiliation': 'Clinica Mediterranea, Napoli, Italy.'}, {'ForeName': 'Kayode O', 'Initials': 'KO', 'LastName': 'Kuku', 'Affiliation': 'Misericordia Hospital, Grosseto, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Rothenbühler', 'Affiliation': 'Clinical Trials Unit, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Alexios', 'Initials': 'A', 'LastName': 'Karagiannis', 'Affiliation': 'Clinical Trials Unit, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Swiss Cardiovascular Center Bern, Bern University Hospital, Freiburgstrasse 8, Bern, Switzerland.'}]",European heart journal cardiovascular Imaging,['10.1093/ehjci/jez040']
1078,31113214,Cluster Randomized Controlled Trial of Disability Education Module During Clinical Clerkship.,"The effect of a randomized disability education program on medical student knowledge and attitudes concerning disability was performed. Intervention group received bedside teaching of physical examination/interview skills and case-based discussion. Twenty-three participants completed the study (control group n = 11; intervention group n = 12). Pre-clerkship, 39% of all participants reported no personal experience and 43% reported no professional experience with people with disabilities. Post-clerkship knowledge was higher for both groups; the test of group-by-time interaction was not significant. Qualitative analysis of post-clerkship attitude responses demonstrated that intervention group gave more detailed answers. Intervention group used terms representing functional aspects of disability twice as frequently as control group. Intervention group responses described long-term experience of a disability within community and family; control group responses focused on acute medical management. Participation in disability education resulted in changed attitude toward disability and better understanding of aspects of disability.",2019,Post-clerkship knowledge was higher for both groups; the test of group-by-time interaction was not significant.,['Twenty-three participants completed the study (control group n = 11; intervention group n = 12'],"['Disability Education Module', 'Intervention group responses described long-term experience of a disability within community and family; control group responses focused on acute medical management', 'randomized disability education program', 'bedside teaching of physical examination/interview skills and case-based discussion']",['medical student knowledge and attitudes concerning disability'],"[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441848', 'cui_str': 'Group N (qualifier value)'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}]","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",23.0,0.029739,Post-clerkship knowledge was higher for both groups; the test of group-by-time interaction was not significant.,"[{'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Santoro', 'Affiliation': 'Massachusetts General Hospital, Boston MA, USA.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Whitgob', 'Affiliation': 'Santa Clara Valley Medical Center, San Jose, CA, USA.'}, {'ForeName': 'Lynne C', 'Initials': 'LC', 'LastName': 'Huffman', 'Affiliation': ""Lucile Packard Children's Hospital, Palo Alto, CA, USA.""}]",Clinical pediatrics,['10.1177/0009922819850475']
1079,31687845,Considering abuse liability and neurocognitive effects of cannabis and cannabis-derived products when assessing analgesic efficacy: a comprehensive review of randomized-controlled studies.,"Background : Pain is the most frequent indication for which medical cannabis treatment is sought. Objectives : The clinical potential of cannabis and cannabis-derived products (CDPs) relies on their efficacy to treat an indication and potential adverse effects that impact outcomes, including abuse liability and neurocognitive effects. To ascertain the extent to which these effects impact therapeutic utility, studies investigating cannabis and CDPs for pain were reviewed for analgesic efficacy and assessments of abuse liability and neurocognitive effects. Methods : A comprehensive review of placebo-controlled studies investigating cannabis and CDP analgesia was performed. Methods and findings related to adverse effects, abuse liability, and neurocognitive effects were extracted. Results : Thirty-eight studies were reviewed; 29 assessed cannabis and CDPs for chronic pain, 1 for acute pain, and 8 used experimental pain tests. Most studies ascertained adverse effects through self-report (N = 27). Fewer studies specifically probed abuse liability (N = 7) and cognitive and psychomotor effects (N = 12). Many studies related to chronic and experimental pain (N = 18 and N = 5, respectively) found cannabis and CDPs to reduce pain. Overall, adverse effects were mild to moderate, and dose-related. Studies investigating the impact of cannabis and CDPs on abuse liability and neurocognitive endpoints were mostly limited to inhaled administration and confirmed dose-related effects. Conclusion : Few studies investigating cannabis and CDP analgesia assess abuse liability and cognitive endpoints, adverse effects that impact the long-term clinical utility of these drugs. Future studies should include these measures to optimize research and clinical care related to cannabis-based therapeutics.",2019,"Overall, adverse effects were mild to moderate, and dose-related.","['Thirty-eight studies were reviewed; 29 assessed cannabis and CDPs for chronic pain, 1 for acute pain, and 8 used experimental pain tests']","['cannabis and cannabis-derived products', 'cannabis and cannabis-derived products (CDPs', ' ', 'placebo']","['analgesic efficacy', 'adverse effects, abuse liability, and neurocognitive effects', 'cognitive and psychomotor effects', 'abuse liability and neurocognitive endpoints', 'Pain', 'adverse effects']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0991028,"Overall, adverse effects were mild to moderate, and dose-related.","[{'ForeName': 'Ziva D', 'Initials': 'ZD', 'LastName': 'Cooper', 'Affiliation': 'UCLA Cannabis Research Initiative, Jane and Terry Semel Institute for Neuroscience and Human Behavior, Department of Psychiatry and Biobehavioral Science, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Donald I', 'Initials': 'DI', 'LastName': 'Abrams', 'Affiliation': 'Divison of Oncology, Department of Medicine, Zuckerberg San Francisco General, University of California San Francisco, San Francisco, CA, USA.'}]",The American journal of drug and alcohol abuse,['10.1080/00952990.2019.1669628']
1080,31609772,Early Palliative Care Consultation in the Medical ICU: A Cluster Randomized Crossover Trial.,"OBJECTIVES


To assess the impact of early triggered palliative care consultation on the outcomes of high-risk ICU patients.
DESIGN


Single-center cluster randomized crossover trial.
SETTING


Two medical ICUs at Barnes Jewish Hospital.
PATIENTS


Patients (n = 199) admitted to the medical ICUs from August 2017 to May 2018 with a positive palliative care screen indicating high risk for morbidity or mortality.
INTERVENTIONS


The medical ICUs were randomized to intervention or usual care followed by washout and crossover, with independent assignment of patients to each ICU at admission. Intervention arm patients received a palliative care consultation from an interprofessional team led by board-certified palliative care providers within 48 hours of ICU admission.
MEASUREMENTS AND MAIN RESULTS


Ninety-seven patients (48.7%) were assigned to the intervention and 102 (51.3%) to usual care. Transition to do-not-resuscitate/do-not-intubate occurred earlier and significantly more often in the intervention group than the control group (50.5% vs 23.4%; p < 0.0001). The intervention group had significantly more transfers to hospice care (18.6% vs 4.9%; p < 0.01) with fewer ventilator days (median 4 vs 6 d; p < 0.05), tracheostomies performed (1% vs 7.8%; p < 0.05), and postdischarge emergency department visits and/or readmissions (17.3% vs 38.9%; p < 0.01). Although total operating cost was not significantly different, medical ICU (p < 0.01) and pharmacy (p < 0.05) operating costs were significantly lower in the intervention group. There was no significant difference in ICU length of stay (median 5 vs 5.5 d), hospital length of stay (median 10 vs 11 d), in-hospital mortality (22.6% vs 29.4%), or 30-day mortality between groups (35.1% vs 36.3%) (p > 0.05).
CONCLUSIONS


Early triggered palliative care consultation was associated with greater transition to do-not-resuscitate/do-not-intubate and to hospice care, as well as decreased ICU and post-ICU healthcare resource utilization. Our study suggests that routine palliative care consultation may positively impact the care of high risk, critically ill patients.",2019,"Although total operating cost was not significantly different, medical ICU (p < 0.01) and pharmacy (p < 0.05) operating costs were significantly lower in the intervention group.","['high-risk ICU patients', 'Two medical ICUs at Barnes Jewish Hospital', 'Patients (n = 199) admitted to the medical ICUs from August 2017 to May 2018 with a positive palliative care screen indicating high risk for morbidity or mortality']",['palliative care consultation from an interprofessional team led by board-certified palliative care providers'],"['ICU length of stay', 'postdischarge emergency department visits and/or readmissions', 'total operating cost', 'hospital mortality', 'transfers to hospice care', 'hospital length of stay', '30-day mortality', 'medical ICU', 'operating costs']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0178443', 'cui_str': 'Jewish, follower of religion (person)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]","[{'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0085555', 'cui_str': 'Hospice Care'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]",97.0,0.0982293,"Although total operating cost was not significantly different, medical ICU (p < 0.01) and pharmacy (p < 0.05) operating costs were significantly lower in the intervention group.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Duke Palliative Care, Department of Medicine, Duke University and Health System, Durham, NC.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Chi', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Buettner', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Pollard', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Muir', 'Affiliation': 'Division of Palliative Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Charu', 'Initials': 'C', 'LastName': 'Kolekar', 'Affiliation': 'Division of Palliative Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Noor', 'Initials': 'N', 'LastName': 'Al-Hammadi', 'Affiliation': 'Division of Biostatistics, Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Division of Biostatistics, Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Marin', 'Initials': 'M', 'LastName': 'Kollef', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dans', 'Affiliation': 'Division of Palliative Medicine, Washington University School of Medicine, St. Louis, MO.'}]",Critical care medicine,['10.1097/CCM.0000000000004016']
1081,31912274,"""She is Like a Sister to Me."" Gender-Affirming Services and Relationships are Key to the Implementation of HIV Care Engagement Interventions with Transgender Women of Color.","We present findings from qualitative interviews (N = 67) with 36 staff and 31 participants of nine distinct individual and/or group level interventions to engage transgender women of color (TWOC) in HIV care in the U.S. We examine the commonalities amongst the intervention services (addressing unmet basic needs, facilitating engagement in HIV care, health system navigation, improving health literacy, emotional support), and the relationships formed during implementation of the interventions (between interventionists and participants, among participants in intervention groups, between participants and peers in the community). Interventionists, often TWOC themselves, who provided these services developed caring relationships, promoted personal empowerment, and became role models for participants and the community. Intervention groups engaged participants to reinforce the importance of health and HIV care and provided mutual support. Gender affirming services and caring relationships may be two key characteristics of interventions that address individual and structural-level barriers to engage TWOC in HIV care.",2020,"Interventionists, often TWOC themselves, who provided these services developed caring relationships, promoted personal empowerment, and became role models for participants and the community.",[],['nine distinct individual and/or group level interventions to engage transgender women of color (TWOC) in HIV care in the U.S'],[],[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",[],,0.045641,"Interventionists, often TWOC themselves, who provided these services developed caring relationships, promoted personal empowerment, and became role models for participants and the community.","[{'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Maiorana', 'Affiliation': 'Center for AIDS Prevention Studies, University of California San Francisco, 550 16th Street, 3rd floor, Box 0886, San Francisco, CA, 94143, USA. andres.maiorana@ucsf.edu.'}, {'ForeName': 'Jae', 'Initials': 'J', 'LastName': 'Sevelius', 'Affiliation': 'Center for AIDS Prevention Studies and Center of Excellence for Transgender Health, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'JoAnne', 'Initials': 'J', 'LastName': 'Keatley', 'Affiliation': 'Center of Excellence for Transgender Health, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Rebchook', 'Affiliation': 'Center for AIDS Prevention Studies, University of California San Francisco, 550 16th Street, 3rd floor, Box 0886, San Francisco, CA, 94143, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02777-6']
1082,31747009,INTELLANCE 2/EORTC 1410 randomized phase II study of Depatux-M alone and with temozolomide vs temozolomide or lomustine in recurrent EGFR amplified glioblastoma.,"BACKGROUND


Depatuxizumab mafodotin (Depatux-M) is a tumor-specific antibody-drug conjugate consisting of an antibody (ABT-806) directed against activated epidermal growth factor receptor (EGFR) and the toxin monomethylauristatin-F. We investigated Depatux-M in combination with temozolomide or as a single agent in a randomized controlled phase II trial in recurrent EGFR amplified glioblastoma.
METHODS


Eligible were patients with centrally confirmed EGFR amplified glioblastoma at first recurrence after chemo-irradiation with temozolomide. Patients were randomized to either Depatux-M 1.25 mg/kg every 2 weeks intravenously, or this treatment combined with temozolomide 150-200 mg/m2 day 1-5 every 4 weeks, or either lomustine or temozolomide. The primary endpoint of the study was overall survival.
RESULTS


Two hundred sixty patients were randomized. In the primary efficacy analysis with 199 events (median follow-up 15.0 mo), the hazard ratio (HR) for the combination arm compared with the control arm was 0.71 (95% CI = 0.50, 1.02; P = 0.062). The efficacy of Depatux-M monotherapy was comparable to that of the control arm (HR = 1.04, 95% CI = 0.73, 1.48; P = 0.83). The most frequent toxicity in Depatux-M treated patients was a reversible corneal epitheliopathy, occurring as grades 3-4 adverse events in 25-30% of patients. In the long-term follow-up analysis with median follow-up of 28.7 months, the HR for the comparison of the combination arm versus the control arm was 0.66 (95% CI = 0.48, 0.93).
CONCLUSION


This trial suggests a possible role for the use of Depatux-M in combination with temozolomide in EGFR amplified recurrent glioblastoma, especially in patients relapsing well after the end of first-line adjuvant temozolomide treatment. (NCT02343406).",2020,"The efficacy of Depatux-M monotherapy was comparable to that of the control arm (HR =1.04, 95%CI","['Eligible were patients with centrally confirmed EGFR amplified glioblastoma at first recurrence after chemo-irradiation with', '260 patients were randomized', 'recurrent EGFRamplified glioblastoma']","['Depatux-M alone and with temozolomide vs temozolomide or lomustine', 'Depatux-M', 'temozolomide', 'Depatux-M monotherapy', '2/EORTC', 'lomustine or temozolomide']","['reversible corneal epitheliopathy', 'hazard ratio (HR', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]","[{'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0023972', 'cui_str': 'Lomustine'}]","[{'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",260.0,0.131555,"The efficacy of Depatux-M monotherapy was comparable to that of the control arm (HR =1.04, 95%CI","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Van Den Bent', 'Affiliation': 'Brain Tumor Institute Erasmus Medical Center (MC) Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Marica', 'Initials': 'M', 'LastName': 'Eoli', 'Affiliation': 'Department of Neurology, Carlo Besta Institute, Milan, Italy.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Sepulveda', 'Affiliation': 'University Hospital 12 October, Madrid, Spain.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Smits', 'Affiliation': 'Department of Radiology, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'Walenkamp', 'Affiliation': 'Department of Medical Oncology, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Jean-Sebastian', 'Initials': 'JS', 'LastName': 'Frenel', 'Affiliation': 'Department of Medical Oncology, René Gauducheau Center for Cancer Care, Nantes, France.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Franceschi', 'Affiliation': 'Department of Medical Oncology, Local Health Unit Agency/Scientific Institute for Research, Hospitalization, and Healthcare (AUSL/IRCCS) Neurological Sciences, Bologna, Italy.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Clement', 'Affiliation': 'Department of Medical Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chinot', 'Affiliation': 'Department of Neuro-Oncology, Institute of Neurophysiopathology, Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'De Vos', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Whenham', 'Affiliation': 'Department of Medical Oncology, European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sanghera', 'Affiliation': 'University Hospitals Birmingham, Birmingham, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Dubbink', 'Affiliation': 'Department of Pathology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'French', 'Affiliation': 'Brain Tumor Institute Erasmus Medical Center (MC) Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Looman', 'Affiliation': 'Abbvie, Chicago, IL USA.'}, {'ForeName': 'Jyotirmoy', 'Initials': 'J', 'LastName': 'Dey', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Krause', 'Affiliation': 'Abbvie, Chicago, IL USA.'}, {'ForeName': 'Pete', 'Initials': 'P', 'LastName': 'Ansell', 'Affiliation': 'Abbvie, Chicago, IL USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Nuyens', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Spruyt', 'Affiliation': 'Brain Tumor Institute Erasmus Medical Center (MC) Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Brilhante', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Coens', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Gorlia', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Golfinopoulos', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}]",Neuro-oncology,['10.1093/neuonc/noz222']
1083,31567351,Ramelteon for Prevention of Postoperative Delirium: A Randomized Controlled Trial in Patients Undergoing Elective Pulmonary Thromboendarterectomy.,"OBJECTIVES


To assess the efficacy of ramelteon in preventing delirium, an acute neuropsychiatric condition associated with increased morbidity and mortality, in the perioperative, ICU setting.
DESIGN


Parallel-arm, randomized, double-blinded, placebo-controlled trial.
SETTING


Academic medical center in La Jolla, California.
PATIENTS


Patients greater than or equal to 18 years undergoing elective pulmonary thromboendarterectomy.
INTERVENTIONS


Ramelteon 8 mg or matching placebo starting the night prior to surgery and for a maximum of six nights while in the ICU.
MEASUREMENTS AND MAIN RESULTS


Incident delirium was measured twice daily using the Confusion Assessment Method-ICU. The safety outcome was coma-free days assessed by the Richmond Agitation-Sedation Scale. One-hundred twenty participants were enrolled and analysis completed in 117. Delirium occurred in 22 of 58 patients allocated to placebo versus 19 of 59 allocated to ramelteon (relative risk, 0.8; 95% CI, 0.5-1.4; p = 0.516). Delirium duration, as assessed by the number of delirium-free days was also similar in both groups (placebo median 2 d [interquartile range, 2-3 d] vs ramelteon 3 d [2-5 d]; p = 0.181). Coma-free days was also similar between groups (placebo median 2 d [interquartile range, 1-3 d] vs ramelteon 3 d [2-4 d]; p = 0.210). We found no difference in ICU length of stay (median 4 d [interquartile range, 3-5 d] vs 4 d [3-6 d]; p = 0.349), or in-hospital mortality (four vs three deaths; relative risk ratio, 0.7; 95% CI, 0.2-3.2; p = 0.717), all placebo versus ramelteon, respectively.
CONCLUSIONS


Ramelteon 8 mg did not prevent postoperative delirium in patients admitted for elective cardiac surgery.",2019,"Delirium occurred in 22 of 58 patients allocated to placebo versus 19 of 59 allocated to ramelteon (relative risk, 0.8; 95% CI, 0.5-1.4; p = 0.516).","['Postoperative Delirium', 'Academic medical center in La Jolla, California', 'Patients Undergoing Elective Pulmonary Thromboendarterectomy', 'Patients greater than or equal to 18 years undergoing elective pulmonary thromboendarterectomy', 'One-hundred twenty participants were enrolled and analysis completed in 117', 'patients admitted for elective cardiac surgery']","['placebo', 'Ramelteon 8 mg or matching placebo']","['ICU length of stay', 'postoperative delirium', 'hospital mortality', 'safety outcome was coma-free days assessed by the Richmond Agitation-Sedation Scale', 'number of delirium-free days', 'Delirium duration', 'Delirium']","[{'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1959997', 'cui_str': 'Pulmonary thromboendarterectomy (procedure)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1652106', 'cui_str': 'ramelteon 8 MG [Rozerem]'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",120.0,0.772122,"Delirium occurred in 22 of 58 patients allocated to placebo versus 19 of 59 allocated to ramelteon (relative risk, 0.8; 95% CI, 0.5-1.4; p = 0.516).","[{'ForeName': 'Stuti J', 'Initials': 'SJ', 'LastName': 'Jaiswal', 'Affiliation': 'Scripps Research Translational Institute, La Jolla, CA.'}, {'ForeName': 'Anuja D', 'Initials': 'AD', 'LastName': 'Vyas', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Heisel', 'Affiliation': 'Division of Hospital Medicine, Scripps Clinic/Scripps Green Hospital, La Jolla, CA.'}, {'ForeName': 'Haritha', 'Initials': 'H', 'LastName': 'Ackula', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Ashna', 'Initials': 'A', 'LastName': 'Aggarwal', 'Affiliation': 'Scripps Research Translational Institute, La Jolla, CA.'}, {'ForeName': 'Nick H', 'Initials': 'NH', 'LastName': 'Kim', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Kerr', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Madani', 'Affiliation': 'Division of Cardiovascular and Thoracic Surgery, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Pretorius', 'Affiliation': 'Division of Cardiovascular and Thoracic Surgery, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Auger', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Fernandes', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Owens', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.'}]",Critical care medicine,['10.1097/CCM.0000000000004004']
1084,31712735,Early symptoms and sensations as predictors of lung cancer: a machine learning multivariate model.,"The aim of this study was to identify a combination of early predictive symptoms/sensations attributable to primary lung cancer (LC). An interactive e-questionnaire comprised of pre-diagnostic descriptors of first symptoms/sensations was administered to patients referred for suspected LC. Respondents were included in the present analysis only if they later received a primary LC diagnosis or had no cancer; and inclusion of each descriptor required ≥4 observations. Fully-completed data from 506/670 individuals later diagnosed with primary LC (n = 311) or no cancer (n = 195) were modelled with orthogonal projections to latent structures (OPLS). After analysing 145/285 descriptors, meeting inclusion criteria, through randomised seven-fold cross-validation (six-fold training set: n = 433; test set: n = 73), 63 provided best LC prediction. The most-significant LC-positive descriptors included a cough that varied over the day, back pain/aches/discomfort, early satiety, appetite loss, and having less strength. Upon combining the descriptors with the background variables current smoking, a cold/flu or pneumonia within the past two years, female sex, older age, a history of COPD (positive LC-association); antibiotics within the past two years, and a history of pneumonia (negative LC-association); the resulting 70-variable model had accurate cross-validated test set performance: area under the ROC curve = 0.767 (descriptors only: 0.736/background predictors only: 0.652), sensitivity = 84.8% (73.9/76.1%, respectively), specificity = 55.6% (66.7/51.9%, respectively). In conclusion, accurate prediction of LC was found through 63 early symptoms/sensations and seven background factors. Further research and precision in this model may lead to a tool for referral and LC diagnostic decision-making.",2019,An interactive e-questionnaire comprised of pre-diagnostic descriptors of first symptoms/sensations was administered to patients referred for suspected LC.,"['Respondents were included in the present analysis only\xa0if they later received a primary LC diagnosis or had no cancer; and inclusion of each descriptor required ≥4 observations', 'primary lung cancer (LC', '506/670 individuals later diagnosed with primary LC (n\u2009=\u2009311) or no cancer (n\u2009=\u2009195']",[],"['cough that varied over the day, back pain/aches/discomfort, early satiety, appetite loss, and having less strength']","[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4517624', 'cui_str': '195'}]",[],"[{'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0234238', 'cui_str': 'Ache'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0239233', 'cui_str': 'Early satiety (fullness)'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}]",63.0,0.067058,An interactive e-questionnaire comprised of pre-diagnostic descriptors of first symptoms/sensations was administered to patients referred for suspected LC.,"[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Levitsky', 'Affiliation': 'Division of Innovative Care Research, Department of Learning, Informatics, Management and Ethics (LIME), Karolinska Institutet, SE-171 77, Solna, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pernemalm', 'Affiliation': 'Cancer Proteomics Mass Spectrometry, Department of Oncology-Pathology, Karolinska Institutet, Science for Life Laboratory, SE-171 65, Solna, Sweden.'}, {'ForeName': 'Britt-Marie', 'Initials': 'BM', 'LastName': 'Bernhardson', 'Affiliation': 'Division of Innovative Care Research, Department of Learning, Informatics, Management and Ethics (LIME), Karolinska Institutet, SE-171 77, Solna, Sweden.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Forshed', 'Affiliation': 'Cancer Proteomics Mass Spectrometry, Department of Oncology-Pathology, Karolinska Institutet, Science for Life Laboratory, SE-171 65, Solna, Sweden.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Kölbeck', 'Affiliation': 'Lung Oncology Center, Cancer Theme, Karolinska University Hospital, SE-171 76, Solna, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Olin', 'Affiliation': 'Lung Oncology Center, Cancer Theme, Karolinska University Hospital, SE-171 76, Solna, Sweden.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Henriksson', 'Affiliation': 'Department of Radiation Sciences and Oncology, University of Umeå, SE-901 87, Umeå, Sweden.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Lehtiö', 'Affiliation': 'Cancer Proteomics Mass Spectrometry, Department of Oncology-Pathology, Karolinska Institutet, Science for Life Laboratory, SE-171 65, Solna, Sweden.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Tishelman', 'Affiliation': 'Division of Innovative Care Research, Department of Learning, Informatics, Management and Ethics (LIME), Karolinska Institutet, SE-171 77, Solna, Sweden.'}, {'ForeName': 'Lars E', 'Initials': 'LE', 'LastName': 'Eriksson', 'Affiliation': 'Division of Innovative Care Research, Department of Learning, Informatics, Management and Ethics (LIME), Karolinska Institutet, SE-171 77, Solna, Sweden. lars.eriksson@ki.se.'}]",Scientific reports,['10.1038/s41598-019-52915-x']
1085,31712574,Early stimulation of the left posterior parietal cortex promotes representation change in problem solving.,"When you suddenly understand how to solve a problem through an original and efficient strategy, you experience the so-called ""Eureka"" effect. The appearance of insight usually occurs after setting the problem aside for a brief period of time (i.e. incubation), thereby promoting unconscious and novel associations on problem-related representations leading to a new and efficient solving strategy. The left posterior parietal cortex (lPPC) has been showed to support insight in problem solving, when this region is activated during the initial representations of the task. The PPC is further activated during the next incubation period when the mind starts to wander. The aim of this study was to investigate whether stimulating the lPPC, either during the initial training on the problem or the incubation period, might enhance representation change in problem solving. To address this question, participants performed the Number Reduction Task (NRT, convergent problem-solving), while excitatory or sham (placebo) transcranial direct current stimulation (tDCS) was applied over the lPPC. The stimulation was delivered either during the initial problem representation or during the subsequent incubation period. Impressively, almost all participants (94%) with excitatory tDCS during the initial training gained representational change in problem solving, compared to only 39% in the incubation period and 33% in the sham groups. We conclude that the lPPC plays a role during the initial problem representation, which may be considerably strengthened by means of short brain stimulation.",2019,"The left posterior parietal cortex (lPPC) has been showed to support insight in problem solving, when this region is activated during the initial representations of the task.",[],"['Number Reduction Task (NRT, convergent problem-solving), while excitatory or sham (placebo) transcranial direct current stimulation (tDCS']",[],[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]",[],,0.0231378,"The left posterior parietal cortex (lPPC) has been showed to support insight in problem solving, when this region is activated during the initial representations of the task.","[{'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Debarnot', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, Villeurbanne, France. Ursula.debarnot@univ-lyon1.fr.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Schlatter', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, Villeurbanne, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Monteil', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, Villeurbanne, France.'}, {'ForeName': 'Aymeric', 'Initials': 'A', 'LastName': 'Guillot', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, Villeurbanne, France.'}]",Scientific reports,['10.1038/s41598-019-52668-7']
1086,31035187,"Effect of physostigmine on recovery from septic shock following intra-abdominal infection - Results from a randomized, double-blind, placebo-controlled, monocentric pilot trial (Anticholium® per Se).","PURPOSE


The cholinergic anti-inflammatory pathway has been shown to be accessible by physostigmine salicylate in animal models. However, the cholinesterase inhibitor is not approved for adjunctive therapy in sepsis, and tolerability and safety of high initial doses followed by continuous infusion have not been investigated.
MATERIALS AND METHODS


In this trial, 20 patients with perioperative septic shock due to intra-abdominal infection were eligible. The physostigmine group received an initial dose of 0.04 mg/kg physostigmine salicylate, followed by continuous infusion of 1 mg/h for 120 h; the placebo group was treated with 0.9% sodium chloride. Primary outcome was the mean Sequential Organ Failure Assessment (SOFA) score during treatment and up to 14 days.
RESULTS


Administration of physostigmine salicylate was well tolerated. Mean SOFA scores were 8.9 ± 2.5 and 11.3 ± 3.6 (mean ± SD) for physostigmine and placebo group, respectively. Adjusted for age, difference between means was not statistically significant (-2.37, 95% CI: -5.43 to 0.70, p = 0.121). Norepinephrine doses required only appeared lower in the physostigmine group (p = 0.064), along with a more rapid reduction from an elevated heart rate possibly indicating less hemodynamic instability.
CONCLUSIONS


Treatment with physostigmine salicylate was feasible and safe. Further studies are justified to assess the effect on recovery from septic shock.
TRIAL REGISTRATION


EudraCT Number 2012-001650-26, ClinicalTrials.gov identifier NCT03013322.",2019,"Norepinephrine doses required only appeared lower in the physostigmine group (p = 0.064), along with a more rapid reduction from an elevated heart rate possibly indicating less hemodynamic instability.
",['20 patients with perioperative septic shock due to intra-abdominal infection were eligible'],"['physostigmine salicylate', 'placebo', 'Norepinephrine', 'physostigmine', '0.9% sodium chloride', 'physostigmine and placebo']","['Mean SOFA scores', 'tolerated', 'mean Sequential Organ Failure Assessment (SOFA) score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1112209', 'cui_str': 'Intra-Abdominal Infections'}]","[{'cui': 'C0071002', 'cui_str': 'physostigmine salicylate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0031849', 'cui_str': 'Physostigmine'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3494459', 'cui_str': 'SOFAS Scores'}]",20.0,0.709518,"Norepinephrine doses required only appeared lower in the physostigmine group (p = 0.064), along with a more rapid reduction from an elevated heart rate possibly indicating less hemodynamic instability.
","[{'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Pinder', 'Affiliation': 'Department of Anesthesiology, Heidelberg University Hospital, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany; Pharmacy Department, Heidelberg University Hospital, Im Neuenheimer Feld 670, 69120 Heidelberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bruckner', 'Affiliation': 'Institute of Medical Biometry and Informatics (IMBI), Heidelberg University Hospital, Marsilius-Arkaden, Tower West, Im Neuenheimer Feld 130.3, 69120 Heidelberg, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Lehmann', 'Affiliation': 'Coordination Centre for Clinical Trials (KKS), Heidelberg University Hospital, Marsilius-Arkaden, Tower West, Im Neuenheimer Feld 130.3, 69120 Heidelberg, Germany.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Motsch', 'Affiliation': 'Department of Anesthesiology, Heidelberg University Hospital, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Brenner', 'Affiliation': 'Department of Anesthesiology, Heidelberg University Hospital, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Larmann', 'Affiliation': 'Department of Anesthesiology, Heidelberg University Hospital, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Knebel', 'Affiliation': 'Department of General, Visceral, and Transplant Surgery, Heidelberg University Hospital, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Hoppe-Tichy', 'Affiliation': 'Pharmacy Department, Heidelberg University Hospital, Im Neuenheimer Feld 670, 69120 Heidelberg, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Swoboda', 'Affiliation': 'Pharmacy Department, Heidelberg University Hospital, Im Neuenheimer Feld 670, 69120 Heidelberg, Germany.'}, {'ForeName': 'Markus A', 'Initials': 'MA', 'LastName': 'Weigand', 'Affiliation': 'Department of Anesthesiology, Heidelberg University Hospital, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hofer', 'Affiliation': 'Department of Anesthesiology, Kaiserslautern Westpfalz Hospital, Hellmut-Hartert-Straße 1, 67655 Kaiserslautern, Germany.'}, {'ForeName': 'Johannes B', 'Initials': 'JB', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Anesthesiology, Heidelberg University Hospital, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany. Electronic address: j.zimmermann@med.uni-heidelberg.de.'}]",Journal of critical care,['10.1016/j.jcrc.2019.04.012']
1087,31103533,Clustered randomized controlled trial of a clinic-based problem-solving intervention to improve adherence in adolescents with cystic fibrosis.,"BACKGROUND


In Cystic Fibrosis (CF), adherence to pulmonary medications is about 50% and decreases during adolescence. Effective interventions have not been integrated into CF care. This effectiveness study tested a brief, clinic-based behavioral intervention to improve adherence.
METHODS


iCARE (I Change Adherence and Raise Expectations) was a pragmatic, clustered, 2-arm randomized controlled trial at 18 CF Centers. 607 adolescents with CF, ages 11-20 years, participated. Centers were randomized to IMPACT (n = 9; 300 adolescents), a brief problem-solving + education intervention, or standard care (SC; n = 9; 307 adolescents). IMPACT was delivered during a regularly scheduled clinic visit by a member of the clinical care team. The primary outcome was composite pulmonary medication possession ratio (cMPR); secondary endpoints were lung function, Body Mass Index percentile, courses of IV antibiotics, and health-related quality of life at 12 months.
RESULTS


Effectiveness of the intervention was tested using mixed models, generalized estimating equations comparing IMPACT to SC. Fifty-eight percent of problem-solving sessions targeted barriers to airway clearance, exercise or nutrition, while 18% addressed pulmonary medications. Average intervention fidelity score was 67% (SD = 14%; Range = 25-100%). No significant intervention effects were found for cMPR or any of the secondary outcomes compared to SC.
CONCLUSIONS


The IMPACT intervention did not improve medication adherence or health outcomes over 12 months. Challenges to implementing the intervention as intended during busy clinic visits were identified.
TRIAL REGISTRY


ClinicalTrials.gov; No.: NCT01232478; URL: www.clinicaltrials.gov.",2019,The IMPACT intervention did not improve medication adherence or health outcomes over 12 months.,"['n\u202f=\u202f9; 307 adolescents', 'adolescents with cystic fibrosis', '607 adolescents with CF, ages 11-20\u202fyears, participated']","['clinic-based behavioral intervention', 'brief problem-solving + education intervention, or standard care (SC', 'clinic-based problem-solving intervention', 'iCARE', 'IMPACT']","['medication adherence or health outcomes', 'composite pulmonary medication possession ratio (cMPR); secondary endpoints were lung function, Body Mass Index percentile, courses of IV antibiotics, and health-related quality of life at 12\u202fmonths', 'Average intervention fidelity score']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",607.0,0.162581,The IMPACT intervention did not improve medication adherence or health outcomes over 12 months.,"[{'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Quittner', 'Affiliation': ""Nicklaus Children's Research Institute, Nicklaus Children's Hospital, Miami, FL, USA. Electronic address: Alexandra.Quittner@mch.com.""}, {'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Eakin', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, The Johns Hopkins School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, MD 21224, USA.'}, {'ForeName': 'Adrianne N', 'Initials': 'AN', 'LastName': 'Alpern', 'Affiliation': 'Department of Psychology, University of Miami, P.O. Box 248185, Miami, FL, USA.'}, {'ForeName': 'Alana K', 'Initials': 'AK', 'LastName': 'Ridge', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, The Johns Hopkins School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, MD 21224, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'McLean', 'Affiliation': 'Department of Psychology, University of Miami, P.O. Box 248185, Miami, FL, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bilderback', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, The Johns Hopkins School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, MD 21224, USA.'}, {'ForeName': 'Kristen K', 'Initials': 'KK', 'LastName': 'Criado', 'Affiliation': 'Department of Psychology, University of Miami, P.O. Box 248185, Miami, FL, USA.'}, {'ForeName': 'Shang-En', 'Initials': 'SE', 'LastName': 'Chung', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, The Johns Hopkins School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, MD 21224, USA.'}, {'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Riekert', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, The Johns Hopkins School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, MD 21224, USA.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2019.05.004']
1088,31478182,Vitamin D supplementation ameliorates severity of generalized anxiety disorder (GAD).,"This study investigated the effects of vitamin D supplementation on Generalized Anxiety Disorder (GAD) clinical symptoms and neurochemical biomarkers including serotonin, neopterin and kynurenine. Thirty male and female patients diagnosed with GAD and had vitamin D deficiency were recruited from the psychiatric clinic at King Abdulaziz University Hospital and divided into two groups; one group of patients (n = 15) received standard of care (SOC) plus 50,000 IU vitamin D (once/week) for 3 months, while the other group (n = 15) received SOC alone. Biochemical parameters including serum vitamin D, serotonin, neopterin and kynurenine were measured for all patients enrolled in the trial. In addition, the Generalized Anxiety Disorder 7-item (GAD-7) scale was used to measure the severity of GAD symptoms in both vitamin D treated- and untreated-patients. Significant improvements in GAD scores were observed in the vitamin D-treated group compared to the group that did not receive vitamin D. In addition, serum serotonin concentrations were significantly increased while serum neopterin were significantly decreased in vitamin D-treated vs. untreated patients. In contrast, no significant differences were found in serum kynurenine concentrations at the end of the study period between the two groups. No changes either in GAD-7 scores or in any of the biochemical measurements were observed in the group that received only SOC after 3 months. Vitamin D supplementation was effective in ameliorating the severity of GAD symptoms by increasing serotonin concentrations and decreasing the levels of the inflammatory biomarker neopterin in GAD patients.",2019,No changes either in GAD-7 scores or in any of the biochemical measurements were observed in the group that received only SOC after 3 months.,"['GAD patients', 'Thirty male and female patients diagnosed with GAD and had vitamin D deficiency were recruited from the psychiatric clinic at King Abdulaziz University Hospital and divided into two groups; one group of patients (n\u2009=\u200915) received', 'generalized anxiety disorder (GAD']","['vitamin D supplementation', 'standard of care (SOC) plus 50,000\xa0IU vitamin D', 'vitamin D', 'SOC alone', 'Vitamin D supplementation']","['severity of GAD symptoms', 'serum vitamin D, serotonin, neopterin and kynurenine', 'serum neopterin', 'serum kynurenine concentrations', 'GAD-7 scores', 'Generalized Anxiety Disorder 7-item (GAD-7) scale', 'Generalized Anxiety Disorder (GAD) clinical symptoms and neurochemical biomarkers including serotonin, neopterin and kynurenine', 'serum serotonin concentrations', 'GAD scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder (disorder)'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0068527', 'cui_str': '2-Amino-6-(1,2,3-trihydroxypropyl)-4(3H)-pteridinone'}, {'cui': 'C0022818', 'cui_str': 'Benzenebutanoic acid, alpha,2-diamino-gamma-oxo-'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder (disorder)'}, {'cui': 'C0222045'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2209695', 'cui_str': 'Serum serotonin'}]",30.0,0.0271414,No changes either in GAD-7 scores or in any of the biochemical measurements were observed in the group that received only SOC after 3 months.,"[{'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Eid', 'Affiliation': 'Department of Biochemistry, Faculty of Science, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Sawsan', 'Initials': 'S', 'LastName': 'Khoja', 'Affiliation': 'Department of Biochemistry, Faculty of Science, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Shareefa', 'Initials': 'S', 'LastName': 'AlGhamdi', 'Affiliation': 'Department of Biochemistry, Faculty of Science, King Abdulaziz University, Jeddah, Saudi Arabia. saaalghamdi1@kau.edu.sa.'}, {'ForeName': 'Hadeil', 'Initials': 'H', 'LastName': 'Alsufiani', 'Affiliation': 'Department of Biochemistry, Faculty of Science, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Faten', 'Initials': 'F', 'LastName': 'Alzeben', 'Affiliation': 'Division of Psychiatry, Department of Internal Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Alhejaili', 'Affiliation': 'Division of Psychiatry, Department of Internal Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Haythum O', 'Initials': 'HO', 'LastName': 'Tayeb', 'Affiliation': 'Division of Neurology, Department of Internal Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Frank I', 'Initials': 'FI', 'LastName': 'Tarazi', 'Affiliation': 'Department of Psychiatry and Neuroscience Program, Harvard Medical School and McLean Hospital, Boston, MA, USA.'}]",Metabolic brain disease,['10.1007/s11011-019-00486-1']
1089,31082669,Radium-223 in combination with docetaxel in patients with castration-resistant prostate cancer and bone metastases: a phase 1 dose escalation/randomised phase 2a trial.,"PURPOSE


Radium 223 dichloride (radium-223) is an alpha particle-emitting bone-directed therapy that prolongs overall survival in men with bone-predominant metastatic castration-resistant prostate cancer (mCRPC). Docetaxel is an antimicrotubule cytotoxic agent that improves survival in mCRPC. We investigated whether combining these potentially cross-sensitising agents to dually target tumour and bone would be safe and effective.
PATIENTS AND METHODS


Phase 1 was a dose escalation study to define a recommended phase 2 dose (RP2D) of docetaxel and radium-223. In phase 2a, patients were randomised 2:1 to the recommended combination regimen or docetaxel at a dose of 75 mg/m 2  every 3 weeks (q3w). Patients with bone-predominant mCRPC were eligible. End-points were safety, efficacy and treatment-related changes in serum and imaging biomarkers.
RESULTS


Twenty patients were enrolled in phase 1; 53 patients were randomised in phase 2a: 36 to combination treatment and 17 to docetaxel alone. The RP2D for the combination was radium-223 55 kBq/kg every six weeks × 5 doses, plus docetaxel 60 mg/m 2  q3w × 10 doses. Febrile neutropenia was dose limiting. A higher rate of febrile neutropenia was seen in the docetaxel monotherapy arm (15% vs 0%); the safety profile of the treatment groups was otherwise similar. The combination arm had more durable suppression of prostate-specific antigen (median time to progression, 6.6 vs 4.8 months, respectively), alkaline phosphatase (9 vs 7 months) and osteoblastic bone deposition markers.
CONCLUSIONS


Radium-223 in combination with docetaxel at the RP2D was well tolerated. Exploratory efficacy data suggested enhanced antitumour activity for the combination relative to docetaxel alone. Comparative studies with end-points of clinical benefit are warranted. ClinicalTrials.gov number: NCT01106352.",2019,"The combination arm had more durable suppression of prostate-specific antigen (median time to progression, 6.6 vs 4.8 months, respectively), alkaline phosphatase (9 vs 7 months) and osteoblastic bone deposition markers.
","['patients with castration-resistant prostate cancer and bone metastases', 'men with bone-predominant metastatic castration-resistant prostate cancer (mCRPC', 'Twenty patients were enrolled in phase 1; 53 patients', 'Patients with bone-predominant mCRPC were eligible']","['Radium 223 dichloride', 'plus docetaxel 60\xa0mg/m 2  q3w', 'Radium-223 in combination with docetaxel', 'docetaxel', 'docetaxel alone', 'docetaxel and radium-223', 'Docetaxel']","['tolerated', 'alkaline phosphatase', 'antitumour activity', 'safety profile', 'Febrile neutropenia', 'rate of febrile neutropenia', 'durable suppression of prostate-specific antigen', 'safety, efficacy\xa0and treatment-related changes in serum and imaging biomarkers', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}]","[{'cui': 'C0303282', 'cui_str': 'Ra-223 radioisotope'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",20.0,0.0447673,"The combination arm had more durable suppression of prostate-specific antigen (median time to progression, 6.6 vs 4.8 months, respectively), alkaline phosphatase (9 vs 7 months) and osteoblastic bone deposition markers.
","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medicine, New York, NY, USA. Electronic address: morrism@mskcc.org.'}, {'ForeName': 'Yohann', 'Initials': 'Y', 'LastName': 'Loriot', 'Affiliation': 'Department of Cancer Medicine, INSERM U981, Gustave Roussy, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Sweeney', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Department of Cancer Medicine, INSERM U981, Gustave Roussy, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Ryan', 'Affiliation': 'Department of Medicine and Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Shevrin', 'Affiliation': 'NorthShore Medical Group, NorthShore University Health System, Evanston Hospital Kellogg Cancer Center, Evanston, IL, USA.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'The Sydney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Neeta', 'Initials': 'N', 'LastName': 'Pandit-Taskar', 'Affiliation': 'Department of Radiology, Molecular Imaging and Therapy Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'Deandreis', 'Affiliation': 'Nuclear Medicine and Endocrine Oncology, Institut Gustave Roussy, University of Paris Sud, Villejuif, France.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Jacene', 'Affiliation': ""Department of Imaging, Dana-Farber Cancer Institute, Boston, MA, USA; Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Vesselle', 'Affiliation': 'Division of Nuclear Medicine, Department of Radiology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Oana', 'Initials': 'O', 'LastName': 'Petrenciuc', 'Affiliation': 'Department of Global Clinical Development, Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Department of Global Clinical Development, Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Carrasquillo', 'Affiliation': 'Department of Radiology, Molecular Imaging and Therapy Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Celestia S', 'Initials': 'CS', 'LastName': 'Higano', 'Affiliation': 'Department of Medicine, University of Washington, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.04.007']
1090,31059974,Prognostic role of serum thymidine kinase 1 activity in patients with hormone receptor-positive metastatic breast cancer: Analysis of the randomised phase III Evaluation of Faslodex versus Exemestane Clinical Trial (EFECT).,"BACKGROUND


Thymidine kinase 1 (TK1) plays a critical role in DNA synthesis and cell proliferation. Recent studies have shown potential for serum TK1 activity (sTKa) as a prognostic marker and indicator of early response to endocrine therapy in advanced breast cancer. The aim of this study is to assess the correlation between sTKa and patient outcome.
PATIENTS AND METHODS


The Evaluation of Faslodex versus Exemestane Clinical Trial (EFECT) was a double-blind, double-dummy, randomised trial of fulvestrant versus exemestane after progression on non-steroidal aromatase inhibitor therapy, in postmenopausal women with advanced breast cancer. Retrospective analyses of serum archived from EFECT were conducted. sTKa was assessed using the DiviTum® assay on samples collected at baseline, after three and six months of endocrine therapy, and at disease progression.
RESULTS


The median time to progression (mTTP) for patients with low baseline sTKa levels was 5.03 months (95% confidence interval [CI]: 3.91-5.89) versus 2.57 months (95% CI: 2.04-3.52) in patients with high sTKa baseline levels (P < 0.0001). On treatment, patients whose sTKa increased from baseline had a significantly shorter mTTP (3.39 months, 95% CI: 2.14-4.11) than those without an sTKa increase (5.39 months, 95% CI: 4.01-6.68) (P = 0.0045). Similar results were observed in the separate EFECT treatment arms. After adjusting for major prognostic factors, sTKa remained an independent marker.
CONCLUSION


sTKa is a potential circulating prognostic marker in patients with advanced breast cancer treated with endocrine therapy. It may also represent a tool for upfront identification of endocrine therapy resistance and early positive response to therapy. Independent validation of these results is warranted.",2019,"On treatment, patients whose sTKa increased from baseline had a significantly shorter mTTP (3.39 months, 95% CI: 2.14-4.11) than those without an sTKa increase (5.39 months, 95% CI: 4.01-6.68) (P = 0.0045).","['patients with hormone receptor-positive metastatic breast cancer', 'advanced breast cancer', 'postmenopausal women with advanced breast cancer', 'patients with advanced breast cancer treated with endocrine therapy']","['sTKa', 'Faslodex versus Exemestane', 'serum thymidine kinase 1 activity', 'fulvestrant versus exemestane']",['median time to progression (mTTP'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}]","[{'cui': 'C0701491', 'cui_str': 'Faslodex'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0295748', 'cui_str': 'thymidine kinase 1'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0069187', 'cui_str': 'O(4)-methylthymidine triphosphate'}]",,0.26271,"On treatment, patients whose sTKa increased from baseline had a significantly shorter mTTP (3.39 months, 95% CI: 2.14-4.11) than those without an sTKa increase (5.39 months, 95% CI: 4.01-6.68) (P = 0.0045).","[{'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'McCartney', 'Affiliation': '""Sandro Pitigliani"" Medical Oncology Department, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Biagioni', 'Affiliation': '""Sandro Pitigliani"" Medical Oncology Department, Hospital of Prato, Prato, Italy; Bioinformatics Unit, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Schiavon', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Bergqvist', 'Affiliation': 'Biovica International, Uppsala, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Mattsson', 'Affiliation': 'Biovica International, Uppsala, Sweden.'}, {'ForeName': 'Ilenia', 'Initials': 'I', 'LastName': 'Migliaccio', 'Affiliation': 'Translational Research Unit, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Benelli', 'Affiliation': 'Bioinformatics Unit, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Romagnoli', 'Affiliation': 'Bioinformatics Unit, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Bonechi', 'Affiliation': 'Translational Research Unit, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Boccalini', 'Affiliation': 'Translational Research Unit, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Pestrin', 'Affiliation': '""Sandro Pitigliani"" Medical Oncology Department, Hospital of Prato, Prato, Italy; Translational Research Unit, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Galardi', 'Affiliation': 'Translational Research Unit, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'De Luca', 'Affiliation': 'Translational Research Unit, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Biganzoli', 'Affiliation': '""Sandro Pitigliani"" Medical Oncology Department, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': 'Department of Medical Oncology, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Gradishar', 'Affiliation': 'Department of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Chia', 'Affiliation': 'Department of Medical Oncology, British Columbia Cancer Agency, Vancouver, BC, Canada.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Di Leo', 'Affiliation': '""Sandro Pitigliani"" Medical Oncology Department, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Malorni', 'Affiliation': '""Sandro Pitigliani"" Medical Oncology Department, Hospital of Prato, Prato, Italy; Translational Research Unit, Hospital of Prato, Prato, Italy. Electronic address: luca.malorni@uslcentro.toscana.it.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.04.002']
1091,31655810,"A Phase 3 Multicenter, Prospective, Open-Label Efficacy and Safety Study of Immune Globulin (Human) 10% Caprylate/Chromatography Purified in Patients with Myasthenia Gravis Exacerbations.","BACKGROUND


Myasthenia gravis (MG) is an autoimmune disorder affecting neuromuscular transmission. Exacerbations may involve increasing bulbar weakness and/or sudden respiratory failure, both of which can be critically disabling. Management of MG exacerbations includes plasma exchange and intravenous immunoglobulin (IVIG); they are equally effective, but patients experience fewer side effects with IVIG. The objective of this study was to assess the efficacy and safety of immune globulin caprylate/chromatography purified (IGIV-C) in subjects with MG exacerbations.
METHODS


This prospective, open-label, non-controlled 28-day clinical trial was conducted in adults with MG Foundation of America class IVb or V status. Subjects received IGIV-C 2 g/kg over 2 consecutive days (1 g/kg/day) and were assessed for efficacy/safety on Days 7, 14, 21, and 28. The primary efficacy endpoint was the change from Baseline in quantitative MG (QMG) score to Day 14. Secondary endpoints of clinical response, Baseline to Day 14, included at least a 3-point decrease in QMG and MG Composite and a 2-point decrease in MG-activities of daily living (MG-ADL).
RESULTS


Forty-nine subjects enrolled. The change in QMG score at Day 14 was significant (p < 0.001) in the Evaluable (-6.4, n = 43) and Safety (-6.7, n = 49) populations. Among evaluable subjects, Day 14 response rates were 77, 86, and 88% for QMG, MG Composite, and MG-ADL, respectively. IGIV-C showed good tolerability with no serious adverse events.
CONCLUSIONS


The results of this study show that IGIV-C was effective, safe, and well tolerated in the treatment of MG exacerbations.",2019,"The change in QMG score at Day 14 was significant (p < 0.001) in the Evaluable (-6.4, n = 43) and Safety (-6.7, n = 49) populations.","['adults with MG Foundation of America class IVb or V status', 'Patients with Myasthenia Gravis Exacerbations', 'subjects with MG exacerbations', 'Forty-nine subjects enrolled']","['immune globulin caprylate/chromatography purified (IGIV-C', 'Caprylate/Chromatography Purified', 'Immune Globulin (Human) 10']","['effective, safe, and well tolerated', 'QMG and MG Composite and a 2-point decrease in MG-activities of daily living (MG-ADL', 'efficacy and safety', 'efficacy/safety', 'QMG score', 'plasma exchange and intravenous immunoglobulin (IVIG', 'quantitative MG (QMG) score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0002454', 'cui_str': 'Americas'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0475273', 'cui_str': 'Venous tumor invasion status values (tumor staging)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia Gravis'}]","[{'cui': 'C0021027', 'cui_str': 'Immune Globulins'}, {'cui': 'C0006930', 'cui_str': 'Octanoates'}, {'cui': 'C0008550', 'cui_str': 'Chromatography'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032113', 'cui_str': 'Plasma Exchange'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}]",49.0,0.147929,"The change in QMG score at Day 14 was significant (p < 0.001) in the Evaluable (-6.4, n = 43) and Safety (-6.7, n = 49) populations.","[{'ForeName': 'Guntis', 'Initials': 'G', 'LastName': 'Karelis', 'Affiliation': 'Department of Infectology and Dermatology, Rīga Stradiņš University, Rīga, Latvia, guntis.karelis@gmail.com.'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Balasa', 'Affiliation': 'Spitalul Clinic Judeţean de Urgenţă Târgu Mureş, Clinica Neurologie I, Târgu Mureş, Romania.'}, {'ForeName': 'Jan L', 'Initials': 'JL', 'LastName': 'De Bleecker', 'Affiliation': 'Department of Neurology and Neuromuscular Reference Center, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Tima', 'Initials': 'T', 'LastName': 'Stuchevskaya', 'Affiliation': 'City Hospital No. 2, Department of Neurology (Neuromuscular Center), Saint Petersburg, Russian Federation.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Villa', 'Affiliation': 'Hospital General de Agudos Dr. J. M. Ramos Mejia Urquiza 609, CABA, Buenos Aires, Argentina.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Van Damme', 'Affiliation': 'Department of Neurology, University Hospitals Leuven, Department of Neurosciences, KU Leuven and Center for Brain and Disease Research, VIB, Leuven, Belgium.'}, {'ForeName': 'Emmeline', 'Initials': 'E', 'LastName': 'Lagrange', 'Affiliation': 'Service de Neurologie, Centre Hospitalier Universitaire de Grenoble, Grenoble, France.'}, {'ForeName': 'Jeannine M', 'Initials': 'JM', 'LastName': 'Heckmann', 'Affiliation': 'Division of Neurology, Department of Medicine, University of Cape Town, New Groote Schuur Hospital, Cape Town, South Africa.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nicolle', 'Affiliation': 'Department of Clinical Neurological Sciences, Western University, London, Ontario, Canada.'}, {'ForeName': 'Crisandra', 'Initials': 'C', 'LastName': 'Vilciu', 'Affiliation': 'Department of Neurology, Institutul Clinic Fundeni, Bucharest, Romania.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Bril', 'Affiliation': 'Ellen and Martin Prosserman Centre for Neuromuscular Diseases, Division of Neurology, Department of Medicine, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Mondou', 'Affiliation': 'Grifols Bioscience Research Group, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Rhonda', 'Initials': 'R', 'LastName': 'Griffin', 'Affiliation': 'Grifols Bioscience Research Group, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Junliang', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Grifols Bioscience Research Group, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Waleska', 'Initials': 'W', 'LastName': 'Henriquez', 'Affiliation': 'Grifols Bioscience Research Group, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Garcia', 'Affiliation': 'Grifols Bioscience Research Group, Sant Cugat del Vallès, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Camprubi', 'Affiliation': 'Grifols Bioscience Research Group, Sant Cugat del Vallès, Spain.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Ayguasanosa', 'Affiliation': 'Grifols Bioscience Research Group, Sant Cugat del Vallès, Spain.'}]",European neurology,['10.1159/000502818']
1092,31526071,Efficacy of Proximal Resin Infiltration on Caries Inhibition: Results from a 3-Year Randomized Controlled Clinical Trial.,"This study reports 3-y outcomes of a split-mouth randomized clinical trial. Resin infiltration's capacity to arrest caries lesion progression in noncavitated proximal lesions is affirmed. Forty-two consented young adults, blinded to tooth surface allocation, were treated with resin infiltration on 1 randomly selected surface and concurrently experienced a mock infiltration procedure on another. Both treatments were provided as an adjunct to the currently accepted standard-of-care regimen (periodic prophylaxis and serial fluoride varnish applications) appropriate for the management of high caries risk. Challenging periods of low oral hygiene compliance were expected. The primary outcome measure was 3-y radiographic lesion progression. Blinded investigators evaluated each study surface for lesion progression with a series of images obtained at intervals over the 3-y course of study. Proportions of progressing lesions were compared with McNemar's test. Twenty-nine noncavitated lesion pairs in permanent posterior teeth demonstrating caries penetrating into inner enamel or outer dentin were included in the analyses. No adverse events were reported. Radiographic progression was recorded in 4 of 29 infiltrated lesions (14%) and 14 of 29 control lesions (48%,  P  < .003). Adjunct resin infiltration demonstrated a high 3-y efficacy of 71% (relative risk reduction). The prevented fraction was 86% for infiltration versus 52% for controls. Resin infiltration was 100% successful in arresting caries progression in inner enamel lesions (E2) and 64% in outer dentin lesions (D1). Supplementary microinvasive resin infiltration is significantly more efficacious in reducing proximal lesion progression than management by standard noninvasive therapy alone. Long-term results may shed light on whether this represents the arrest or delay of the caries disease process (ClinicalTrials.gov NCT01584024).",2019,Resin infiltration was 100% successful in arresting caries progression in inner enamel lesions (E2) and 64% in outer dentin lesions (D1).,"['Forty-two consented young adults', 'Twenty-nine noncavitated lesion pairs in permanent posterior teeth demonstrating caries penetrating into inner enamel or outer dentin']",['Proximal Resin Infiltration'],"['Radiographic progression', 'adverse events', 'proximal lesion progression', 'Caries Inhibition', '3-y radiographic lesion progression']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0205321', 'cui_str': 'Penetrating (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]",,0.0841222,Resin infiltration was 100% successful in arresting caries progression in inner enamel lesions (E2) and 64% in outer dentin lesions (D1).,"[{'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Peters', 'Affiliation': 'School of Dentistry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Hopkins', 'Affiliation': 'Operative and Comprehensive Dentistry, USADC West Point, NY, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Biostatistics Program, Louisiana State University, New Orleans, LA, USA.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Biostatistics Program, Louisiana State University, New Orleans, LA, USA.'}]",Journal of dental research,['10.1177/0022034519876853']
1093,31099033,Possibility of a risk-adapted treatment strategy for untreated aggressive adult T-cell leukaemia-lymphoma (ATL) based on the ATL prognostic index: a supplementary analysis of the JCOG9801.,"JCOG9801, a randomized phase III trial, reported that vincristine, cyclophosphamide, doxorubicin and prednisone (VCAP); doxorubicin, ranimustine and prednisone (AMP); and vindesine, etoposide, carboplatin and prednisone (VECP) (VCAP-AMP-VECP; mLSG15) showed superior clinical outcomes when compared to cyclophosphamide, doxorubicin, vincristine and prednisone every 2 weeks (CHOP-14; mLSG19) in patients with untreated aggressive adult T-cell leukaemia-lymphoma (ATL). To identify patients who require VCAP-AMP-VECP, we conducted a supplementary analysis of JCOG9801. Overall, 105 patients were included and categorized into low- (n = 44), intermediate- (n = 54) and high-risk (n = 7) groups according to the age-adjusted ATL prognostic index (ATL-PI). We excluded the high-risk group due to small numbers of patients. VCAP-AMP-VECP did not show any superior trend for overall survival (OS) in the low-risk group (hazard ratio: 1·04; 95% confidence interval: 0·54-2·04). Better OS was observed in the intermediate-risk group treated with VCAP-AMP-VECP (hazard ratio: 0·65; 95% confidence interval: 0·36-1·19). In the intermediate-risk group, the VCAP-AMP-VECP arm showed higher complete response rates than the CHOP-14 arm (44·0% vs. 13·8%). The VCAP-AMP-VECP arm in both risk groups exhibited grade 4 thrombocytopenia, while grade 4 neutropenia was only observed in the intermediate-risk group. VCAP-AMP-VECP remains suitable for the intermediate-risk group, whereas its benefits appear modest in the low-risk group.",2019,VCAP-AMP-VECP did not show any superior trend for overall survival (OS) in the low-risk group (hazard ratio: 1·04; 95% confidence interval: 0·54-2·04).,"['untreated aggressive adult T-cell leukaemia-lymphoma (ATL', 'patients who require VCAP-AMP-VECP', 'patients with untreated aggressive adult T-cell leukaemia-lymphoma (ATL', '105 patients were included and categorized into low']","['VCAP-AMP-VECP', 'vincristine, cyclophosphamide, doxorubicin and prednisone (VCAP); doxorubicin, ranimustine and prednisone (AMP); and vindesine, etoposide, carboplatin and prednisone (VECP) (VCAP-AMP-VECP; mLSG15', 'JCOG9801', 'cyclophosphamide, doxorubicin, vincristine and prednisone every 2\xa0weeks (CHOP-14; mLSG19']","['Better OS', 'grade 4 thrombocytopenia, while grade 4 neutropenia', 'complete response rates', 'overall survival (OS']","[{'cui': 'C0023493', 'cui_str': 'ATLL'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0645200', 'cui_str': 'diphosphoribosyl-adenosine monophosphate'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0645200', 'cui_str': 'diphosphoribosyl-adenosine monophosphate'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0243666', 'cui_str': 'ranimustine'}, {'cui': 'C0042682', 'cui_str': 'Vindesine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",105.0,0.0402397,VCAP-AMP-VECP did not show any superior trend for overall survival (OS) in the low-risk group (hazard ratio: 1·04; 95% confidence interval: 0·54-2·04).,"[{'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'Department of Hematology, Rheumatology and Infectious Diseases, Faculty of Life Sciences, Kumamoto University of Medicine, Kumamoto, Japan.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Tsukasaki', 'Affiliation': 'Department of Hematology, International Medical Centre, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Ryunosuke', 'Initials': 'R', 'LastName': 'Machida', 'Affiliation': 'Japan Clinical Oncology Group Data Centre/Operations Office, National Cancer Centre Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Kadota', 'Affiliation': 'Japan Clinical Oncology Group Data Centre/Operations Office, National Cancer Centre Hospital, Tokyo, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Fukushima', 'Affiliation': 'Laboratory of Hematoimmunology, School of Health Sciences, Faculty of Medicine, University of the Ryukyus, Okinawa, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ishitsuka', 'Affiliation': 'Department of Hematology and Immunology, Kagoshima University Hospital, Kagoshima, Japan.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Maruyama', 'Affiliation': 'Department of Hematology, National Cancer Centre Hospital, Tokyo, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Nagai', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagoya Medical Centre, Nagoya, Japan.'}]",British journal of haematology,['10.1111/bjh.15950']
1094,31109849,"Hereditary angioedema, emergency management of attacks by a call center.","OBJECTIVE


Hereditary angiœdema (HAE) is a rare autosomal dominant disease characterized by recurrent, unpredictable, potentially life-threatening swelling. Objective is to assess the management of the acute HAE attacks in the real life setting through a call center in France.
METHODS


A pre-specified ancillary study of SOS-HAE, a cluster-randomized prospective multicenter trial, was conducted. HAE patients were recruited from 8 participating reference centers. The outcome of interest was the rate of hospitalization.
RESULTS


onerhundred patients were included. The median (quartile) age was 38 (29-53) years, and 66 (66%) were female. Eighty (80%) patients had HAE type I, 8 (8%) had HAE type II and 12 (12%) patients had FXII-HAE. Fifty-one (51%) patients had experienced at least one time the call center during the follow-up. Nine over 166 (5%) attacks for 9 different patients resulted in hospital admission to the hospital (in the short-stay unit, ie, <24 h) during the follow-up period. During 2 years, there were 166 calls to call center for 166 attacks. All attacks were treated at home after call center contact.
CONCLUSIONS


Use of emergency departments and hospitalizations are reduced by the use of a coordinated national call center in HAE after therapeutic education program that promoted self-administration of specific treatment and use of call to call center.
TRIAL REGISTRATION


clinicalTrials.gov identifier: NCT01679912.",2019,"CONCLUSIONS


Use of emergency departments and hospitalizations are reduced by the use of a coordinated national call center in HAE after therapeutic education program that promoted self-administration of specific treatment and use of call to call center.
","['onerhundred patients were included', 'Eighty (80', 'Fifty-one (51', 'HAE patients were recruited from 8 participating reference centers', 'patients had HAE type I, 8 (8%) had HAE type II and 12 (12', 'The median (quartile) age was 38 (29-53) years, and 66 (66%) were female']",['SOS-HAE'],"['rate of hospitalization', 'FXII-HAE', 'hospital admission to the hospital']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]",[],"[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",,0.0954971,"CONCLUSIONS


Use of emergency departments and hospitalizations are reduced by the use of a coordinated national call center in HAE after therapeutic education program that promoted self-administration of specific treatment and use of call to call center.
","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Javaud', 'Affiliation': 'AP-HP, Urgences, Centre de référence sur les angiœdèmes à kinines, Hôpital Louis Mourier, Université Paris 7, 92700 Colombes, France; AP-HP, Urgences - Samu 93, Hôpital Avicenne, Université Paris 13, Inserm U942, 93000 Bobigny, France. Electronic address: nicolas.javaud@aphp.fr.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Altar', 'Affiliation': 'AP-HP, Urgences, Centre de référence sur les angiœdèmes à kinines, Hôpital Louis Mourier, Université Paris 7, 92700 Colombes, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Fain', 'Affiliation': 'AP-HP, Médecine Interne, DHUi2B, Centre de Référence associé sur les angiœdèmes à kinines (CRéAk), Hôpital Saint-Antoine, Université Paris 6, 75 012 Paris, France. Electronic address: olivier.fain@aphp.fr.'}, {'ForeName': 'Paul-Georges', 'Initials': 'PG', 'LastName': 'Reuter', 'Affiliation': 'AP-HP, Urgences - Samu 93, Hôpital Avicenne, Université Paris 13, Inserm U942, 93000 Bobigny, France. Electronic address: paul-georges.reuter@aphp.fr.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Desmaizieres', 'Affiliation': 'AP-HP, Urgences - Samu 93, Hôpital Avicenne, Université Paris 13, Inserm U942, 93000 Bobigny, France. Electronic address: michel.desmaizieres@aphp.fr.'}, {'ForeName': 'Tomislav', 'Initials': 'T', 'LastName': 'Petrovic', 'Affiliation': 'AP-HP, Urgences - Samu 93, Hôpital Avicenne, Université Paris 13, Inserm U942, 93000 Bobigny, France. Electronic address: tomislav.petrovic@aphp.fr.'}, {'ForeName': 'Aiham', 'Initials': 'A', 'LastName': 'Ghazali', 'Affiliation': 'AP-HP, Urgences, Hôpital Bichat, Université Paris 7, 75018 Paris, France.. Electronic address: aiham.ghazali@aphp.fr.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Durand-Zaleski', 'Affiliation': ""AP-HP, URCEco Ile de France, Hôpital de l'Hôtel-Dieu, Université Paris 12, 75 004 Paris, France. Electronic address: isabelle.durand-zaleski@aphp.fr.""}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Bouillet', 'Affiliation': 'Médecine Interne, Centre de Référence sur les angiœdèmes à kinines (CRéAk), CHU de Grenoble, 38043 Grenoble, France. Electronic address: LBouillet@chu-grenoble.fr.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'AP-HP, Unité de Recherche Clinique, Hôpital Fernand Widal, Paris, France. Electronic address: eric.vicaut@aphp.fr.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Launay', 'Affiliation': 'Université de Lille, CHRU de Lille, Médecine Interne, Centre de Référence sur les angiœdèmes à kinines (CRéAk), Hôpital Claude Huriez, 59037 Lille Cedex, France. Electronic address: david.launay@chru-lille.fr.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': ""Dermatologie, Centre de Référence sur les angiœdèmes à kinines (CRéAk), Université d'Angers, CHU d'Angers, 49 933 Angers, cedex, France. Electronic address: LuMartin@chu-angers.fr.""}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Floccard', 'Affiliation': 'Hospices Civils de Lyon, Réanimation, Centre de Référence sur les angiœdèmes à kinines (CRéAk), CHU Edouard Herriot, 69 437 Lyon, Cedex, France. Electronic address: bernard.floccard@chu-lyon.fr.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gompel', 'Affiliation': 'Université de Paris-Descartes, AP-HP, HUPC, Unité de Gynécologie Endocrinienne, Hôpital Port Royal, 75001 Paris, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Sobel', 'Affiliation': 'AP-HP, Hôpital Hôtel Dieu, Université Paris 5, 75004 Paris, France. Electronic address: alain.sobel@aphp.fr.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boccon-Gibod', 'Affiliation': 'Médecine Interne, Centre de Référence sur les angiœdèmes à kinines (CRéAk), CHU de Grenoble, 38043 Grenoble, France. Electronic address: IBoccon-gibod@chu-grenoble.fr.'}, {'ForeName': 'Gisele', 'Initials': 'G', 'LastName': 'Kanny', 'Affiliation': 'Médecine Interne, Centre de Référence sur les angiœdèmes à kinines (CRéAk), CHU de Nancy, 54 035 Nancy, France. Electronic address: gisele.kanny@univ-lorraine.fr.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Lapostolle', 'Affiliation': 'AP-HP, Urgences - Samu 93, Hôpital Avicenne, Université Paris 13, Inserm U942, 93000 Bobigny, France. Electronic address: frederic.lapostolle@aphp.fr.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Adnet', 'Affiliation': 'AP-HP, Urgences - Samu 93, Hôpital Avicenne, Université Paris 13, Inserm U942, 93000 Bobigny, France. Electronic address: frederic.adnet@aphp.fr.'}]",European journal of internal medicine,['10.1016/j.ejim.2019.05.007']
1095,31099272,Economic evaluation of a supported employment program for veterans with spinal cord injury.,"Objective:  To estimate the net monetary benefit of an individual placement and support-based supported employment program for Veterans with spinal cord injuries. Design:  Economic evaluation comparing a supported employment program to treatment as usual, using cost and quality-of-life data from a longitudinal study of Veterans with spinal cord injuries. Setting:  Spinal cord injury centers in the Veterans Health Administration. Participants:  Subjects ( N  = 213) who participated in a 24-month supported employment program at seven spinal cord injury centers. Supported employment participants were compared with a group of spinal cord injury Veterans who received treatment as usual in a prior study. Main outcome measures:  Costs and quality-adjusted life years using the Veterans Rand-6 Dimension, estimated from the Veterans Rand 36-Item Health Survey. Results:  The supported employment program was more effective at both 1- and 2-year periods compared with treatment as usual. Outpatient costs were significantly higher for supported employment, but inpatient costs were not significantly different from treatment as usual. When cost and effectiveness were compared jointly using net monetary benefit, a supported employment program following the core principles of Individual Placement and Supported employment was more effective but not cost-effective at standard willingness to pay thresholds. When we considered a sub-group of the supported employment participants who more closely resemble the treatment as usual group from a randomized trial, there was no significant difference in the cost-effectiveness of supported employment when compared to treatment as usual. Conclusions:  With higher effectiveness and similar costs, supported employment for spinal cord injury Veterans has the potential to be cost-effective. Future studies need to randomize participants or carefully match participants based on observable patient characteristics to improve cost-effectiveness evaluations of this population.Implications for RehabilitationSupported employment as part of ongoing rehabilitation care helps individuals with spinal cord injury return to work and improve their quality of life.Many studies show that supported employment programs are cost effective for persons with mental disabilities, but there is only limited economic evaluation data on use of supported employment with persons with spinal cord injury.This study shows that supported employment integrated with ongoing rehabilitation care is more effective in restoring employment and health-related quality of life.",2020,"Outpatient costs were significantly higher for supported employment, but inpatient costs were not significantly different from treatment as usual.","['Veterans with spinal cord injuries', 'Subjects (N\u2009=\u2009213) who participated in a 24-month supported employment program at seven spinal cord injury centers', 'Spinal cord injury centers in the Veterans Health Administration', 'spinal cord injury Veterans', 'veterans with spinal cord injury', 'persons with mental disabilities']","['individual placement and support-based supported employment program', 'supported employment program']","['Costs and quality-adjusted life years using the Veterans Rand-6 Dimension, estimated from the Veterans Rand 36-Item Health Survey', 'inpatient costs', 'cost-effectiveness of supported employment', 'Outpatient costs']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0085362', 'cui_str': 'Employment, Supported'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0178672', 'cui_str': 'Health administration'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1306341', 'cui_str': 'Mental handicap (finding)'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085362', 'cui_str': 'Employment, Supported'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0014003', 'cui_str': 'Employment'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]",,0.054043,"Outpatient costs were significantly higher for supported employment, but inpatient costs were not significantly different from treatment as usual.","[{'ForeName': 'Bryce S', 'Initials': 'BS', 'LastName': 'Sutton', 'Affiliation': 'Center of Innovation on Disability and Rehabilitation Research, James A. Haley Veterans Hospital, Tampa, FL, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ottomanelli', 'Affiliation': 'Center of Innovation on Disability and Rehabilitation Research, James A. Haley Veterans Hospital, Tampa, FL, USA.'}, {'ForeName': 'Eni', 'Initials': 'E', 'LastName': 'Njoh', 'Affiliation': 'Center of Innovation on Disability and Rehabilitation Research, James A. Haley Veterans Hospital, Tampa, FL, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Barnett', 'Affiliation': 'Center of Innovation on Disability and Rehabilitation Research, James A. Haley Veterans Hospital, Tampa, FL, USA.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Goetz', 'Affiliation': 'Hunter Holmes McGuire VA Medical Center, Richmond, VI, USA.'}]",Disability and rehabilitation,['10.1080/09638288.2018.1527955']
1096,31095810,Evaluation of four injection profiles for uniform contrast-enhanced signal intensity profiles in MR angiography.,"BACKGROUND


Gadolinium concentration variation during acquisition of contrast-enhanced MR angiography (CE-MRA) may lead to artifacts.
PURPOSE


To compare signal intensity (SI) profiles of four different contrast agent injection strategies during CE-MRA with the goal of minimizing SI variation during acquisition.
STUDY TYPE


Prospective.
SUBJECTS


Forty subjects randomized to receive one of four injection profiles of gadobenate dimeglumine (0.1 mmol/kg), either undiluted (0.5 M) or diluted to 40 ml total volume. Tested profiles: 1) nondiluted single-phase (""standard"" NS; 1.6 ml/s), 2) diluted single-phase (DS; 1.6 ml/s), 3) diluted biphasic (DB; 9 ml @ 3.3 ml/s, 29 ml @ 1.4 ml/s), 4) patient-tailored protocol using linear prediction (DT).
FIELD STRENGTH/SEQUENCE


Time-resolved SI measured at 3T with spoiled gradient echo sequences having analogous parameters to those of CE-MRA.
ASSESSMENT


Plateau arrival time, rise time, duration, peak and tail SI, plateau quality (sum of squared residuals; SSR), average SI for each injection type derived were used.
STATISTICAL TEST


Two-tailed t-test.
RESULTS


Peak SI, arrival, and rise times were not significantly different between groups, excepting peak SI DB slightly > DS (P = 0.042). Duration of NS vs. the diluted groups was significantly shorter (all P < 0.0001), and DS duration was significantly shorter than that of DT and DB (NS 11.4 ± 3.5 vs. DS 22.9 ± 4.3, DB 25.4 ± 2.3, DT 28.3 ± 4.1 sec). Quality (SSR) of the 20-second plateau was significantly better for DS, DB, DT as compared with NS (all P < 0.001).
DATA CONCLUSION


Three different strategies to power-inject diluted gadobenate dimeglumine targeting a 20-second plateau produced SI profiles with longer duration, more consistent plateau, and no significant loss in peak SI. Such injection profiles may provide more uniform SI during CE-MRA, potentially reducing blurring artifacts.
LEVEL OF EVIDENCE


2 Technical Efficacy: Stage 1 J. Magn. Reson. Imaging 2019;50:1808-1816.",2019,"Quality (SSR) of the 20-second plateau was significantly better for DS, DB, DT as compared with NS (all P < 0.001).
","['MR angiography', 'Forty subjects']","['diluted biphasic (DB; 9 ml ', 'gadobenate dimeglumine', 'undiluted (0.5 M) or diluted to 40 ml total volume', 'MR angiography (CE-MRA']","['DS duration', 'peak SI', 'Plateau arrival time, rise time, duration, peak and tail SI, plateau quality (sum of squared residuals; SSR), average SI', 'Quality (SSR', 'signal intensity (SI) profiles', 'Peak SI, arrival, and rise times']","[{'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0205184', 'cui_str': 'Biphasic (qualifier value)'}, {'cui': 'C0209453', 'cui_str': 'Gadobenate dimeglumine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0039259', 'cui_str': 'Tail'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",40.0,0.0486019,"Quality (SSR) of the 20-second plateau was significantly better for DS, DB, DT as compared with NS (all P < 0.001).
","[{'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Maki', 'Affiliation': 'The Department of Radiology, University of Colorado Denver, Aurora, Colorado, USA.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Wilson', 'Affiliation': 'Department of Radiology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Toshimasa J', 'Initials': 'TJ', 'LastName': 'Clark', 'Affiliation': 'The Department of Radiology, University of Colorado Denver, Aurora, Colorado, USA.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.26793']
1097,31207232,Guselkumab Efficacy after Withdrawal Is Associated with Suppression of Serum IL-23-Regulated IL-17 and IL-22 in Psoriasis: VOYAGE 2 Study.,"BACKGROUND


Guselkumab selectively inhibits IL-23 and in psoriasis, produces high clinical responses, including durable maintenance after treatment withdrawal in some patients. The relationships between IL-23 blockade, serum markers downstream of IL-23 signaling, and withdrawal were explored with guselkumab in VOYAGE 2.
METHODS


At week 28, patients with ≥90% Psoriasis Area and Severity Index improvement from baseline (PASI 90) were rerandomized to withdrawal and received placebo (n = 182), or maintenance therapy (n = 193). The guselkumab withdrawal group reinitiated guselkumab upon loss of ≥50% of week- 28 PASI improvement or by week 72. Cytokine changes associated with psoriasis recurrence (serum IL-17A, IL-17F, IL-22, and IL-23) after withdrawal were evaluated.
RESULTS


Efficacy in the guselkumab maintenance group was sustained through week 72, whereas efficacy diminished in the guselkumab withdrawal group (PASI 90, 86.0% vs. 11.5%). After 20 weeks of retreatment, 80.4% of guselkumab withdrawal patients achieved PASI 90 responses versus baseline. Maintenance of response after withdrawal was associated with suppression of IL-17A, IL-17F, and IL-22. Increases in cytokine levels had poor predictive power for psoriasis reoccurrence as these increases lagged behind increases in PASI scores.
CONCLUSION


Upon guselkumab withdrawal, most patients lost clinical response and regained responses with retreatment. Correlation of IL-23 signaling serum cytokines increased with disease recurrence, supporting the role of IL-23 in expansion and maintenance of CD4+ T helper type 17, T helper type 22, and related CD8+ T-cell subsets producing IL-17A, IL-17F, and IL-22.",2019,"Maintenance of response following withdrawal was associated with suppression of IL-17A, IL-17F and IL-22.",[],['placebo'],"['psoriasis recurrence (serum IL-17A, IL-17F, IL-22, and IL-23', 'PASI 90 responses', 'PASI scores']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1705947', 'cui_str': 'CTLA8'}, {'cui': 'C1705097', 'cui_str': 'Interleukin-17F'}, {'cui': 'C0961814', 'cui_str': 'interleukin-22'}, {'cui': 'C0963088', 'cui_str': 'IL-23'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0857612,"Maintenance of response following withdrawal was associated with suppression of IL-17A, IL-17F and IL-22.","[{'ForeName': 'Kenneth B', 'Initials': 'KB', 'LastName': 'Gordon', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'April W', 'Initials': 'AW', 'LastName': 'Armstrong', 'Affiliation': 'University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Foley', 'Affiliation': ""The University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia; Probity Medical Research Inc., Skin & Cancer Foundation Inc., Carlton, Victoria, Australia.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Yaung-Kaung', 'Initials': 'YK', 'LastName': 'Shen', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Ernesto J', 'Initials': 'EJ', 'LastName': 'Muñoz-Elías', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Branigan', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Xuejun', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Skinflammation Center, Hamburg, Germany; Dermatologikum Berlin, Berlin, Germany. Electronic address: k.reich@uke.de.'}]",The Journal of investigative dermatology,['10.1016/j.jid.2019.05.016']
1098,31740973,Recoarctation of the aorta after the Norwood procedure may be treated during the second stage of the surgical palliation.,"OBJECTIVES


Recoarctation of the aorta (re-CoA) after the Norwood procedure is traditionally treated during catheter-based aortoplasty (CB-A) performed as a separate procedure preceding stage II surgical palliation (S II SP). Our goal was to determine the efficacy of the protocol according to which re-CoA after the Norwood procedure in patients with hypoplastic left heart syndrome is treated during S II SP using hybrid catheter-based aortoplasty.
METHODS


We compared 2 groups of infants who developed re-CoA after the Norwood procedure and were treated at the same institution: In group I (n = 18), CB-A was traditionally performed before S II SP; in group II (n = 15), CB-A was performed during S II SP using a hybrid procedure (catheter access was through an aortic cannula routinely used for cardiopulmonary bypass). The right ventricular fractional area change was analysed.
RESULTS


The CB-A was performed effectively in both groups. S II SP was performed at a younger age in group II (5.4 ± 0.3 vs 6.0 ± 0.4 months; P = 0.003), with lower body weight (5.6 ± 0.5 vs 6.0 ± 0.4; P = 0.03, respectively). The duration of hospital stay did not differ between the groups (10.6 ± 6.2 vs 11.6 ± 6.4 days; P = 0.91). The right ventricular fractional area change measured before S II SP was higher in group I (39.7 ± 4.2% vs 36.8 ± 3.6%, respectively; P = 0.009), but the difference was not seen 1 month after S II SP (41.0 ± 5.6 vs 39.8 ± 4.1; P > 0.05). The total radiation dose was significantly lower in group II.
CONCLUSIONS


re-CoA after the Norwood procedure in patients with hypoplastic left heart syndrome can be treated effectively during S II SP using a hybrid procedure. The strategy allows for reduction of the total radiation dose and of the number of procedures and does not prolong the postoperative course, even in patients with decreased right ventricular systolic function.",2019,"The strategy allows for reduction of the total radiation dose and of the number of procedures and does not prolong the postoperative course, even in patients with decreased right ventricular systolic function.",['patients with hypoplastic left heart syndrome'],"['CB-A was traditionally performed before S II SP', 'CB-A was performed during S II SP using a hybrid procedure']","['total radiation dose', 'duration of hospital stay', 'right ventricular systolic function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0152101', 'cui_str': 'Left Heart Hypoplasia Syndrome'}]","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.022685,"The strategy allows for reduction of the total radiation dose and of the number of procedures and does not prolong the postoperative course, even in patients with decreased right ventricular systolic function.","[{'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Mroczek', 'Affiliation': 'Department of Pediatric Cardiac Surgery, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Czerżyńska', 'Affiliation': 'Department of Pediatric Cardiac Surgery, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Julita', 'Initials': 'J', 'LastName': 'Sacharczuk', 'Affiliation': 'Department of Pediatric Cardiac Surgery, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Żurek', 'Affiliation': 'Department of Pediatric Cardiac Surgery, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Elżbieta', 'Initials': 'E', 'LastName': 'Wójcik', 'Affiliation': 'Department of Pediatric Cardiac Surgery, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Morka', 'Affiliation': 'Department of Pediatric Cardiac Surgery, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Kuźma', 'Affiliation': 'Department of Pediatric Cardiology, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Janusz H', 'Initials': 'JH', 'LastName': 'Skalski', 'Affiliation': 'Department of Pediatric Cardiac Surgery, Jagiellonian University Medical College, Krakow, Poland.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezz241']
1099,31719604,Total adiponectin is associated with incident cardiovascular and renal events in treated hypertensive patients: subanalysis of the ATTEMPT-CVD randomized trial.,"The predictive value of serum adiponectin for hypertensive cardiovascular outcomes is unknown. This study was performed to investigate the association of adiponectin with incident cardiovascular and renal events (CV events) in hypertensive patients. We performed post-hoc analysis on 1,228 hypertensive patients enrolled in the ATTEMPT-CVD study, a prospective randomized study comparing the effects of two antihypertensive therapies. The participants were divided into quartiles of baseline serum total adiponectin or high molecular weight (HMW) adiponectin. Multivariable Cox proportional hazards analysis was performed to determine the prognostic factors associated with CV events. Kaplan-Meier analysis for CV events by quartiles of baseline total adiponectin showed that patients in the highest total adiponectin quartile (Q4) had more CV events (P = 0.0135). On the other hand, no significant difference was noted regarding the incidence of CV events among patients stratified by HMW adiponectin quartile (P = 0.2551). Even after adjustment for potential confounders, the highest total adiponectin quartile (Q4) remained independently associated with incident CV events in hypertensive patients (HR = 1.949: 95%CI 1.051-3.612; P = 0.0341). These results showed that total adiponectin, but not HMW adiponectin, was independently associated with the incidence of CV events in treated hypertensive patients, thereby highlighting total adiponectin as a valuable predictor for hypertensive cardiovascular outcomes.",2019,Kaplan-Meier analysis for CV events by quartiles of baseline total adiponectin showed that patients in the highest total adiponectin quartile (Q4) had more CV events (P = 0.0135).,"['1,228 hypertensive patients enrolled in the ATTEMPT-CVD study', 'hypertensive patients', 'treated hypertensive patients']",[],"['CV events', 'incident CV events', 'incidence of CV events', 'baseline serum total adiponectin or high molecular weight (HMW) adiponectin', 'adiponectin with incident cardiovascular and renal events (CV events', 'highest total adiponectin quartile (Q4', 'total adiponectin']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]",[],"[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C2733715', 'cui_str': 'High molecular weight adiponectin (substance)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.019825,Kaplan-Meier analysis for CV events by quartiles of baseline total adiponectin showed that patients in the highest total adiponectin quartile (Q4) had more CV events (P = 0.0135).,"[{'ForeName': 'Shokei', 'Initials': 'S', 'LastName': 'Kim-Mitsuyama', 'Affiliation': 'Department of Pharmacology and Molecular Therapeutics, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan. mitsuyam@gpo.kumamoto-u.ac.jp.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Soejima', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yasuda', 'Affiliation': 'Department of Sports and Life Sciences, National Institute of Fitness and Sports in Kanoya, Kanoya, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Jinnouchi', 'Affiliation': 'Diabetes Care Center, Jinnouchi Clinic, Kumamoto, Japan.'}, {'ForeName': 'Eiichiro', 'Initials': 'E', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Taiji', 'Initials': 'T', 'LastName': 'Sekigami', 'Affiliation': 'Division of Internal Medicine & Diabetes and Endocrine, Sekigami Clinic, Yatsushiro, Japan.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': 'National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Matsui', 'Affiliation': 'Department of General and Community Medicine, Kumamoto University Hospital, Kumamoto, Japan.'}]",Scientific reports,['10.1038/s41598-019-52977-x']
1100,30815689,Rifampicin effect on intracellular and plasma pharmacokinetics of tenofovir alafenamide.,"OBJECTIVES


Tenofovir alafenamide produces lower plasma tenofovir and higher intracellular tenofovir diphosphate (DP) concentrations than tenofovir disoproxil fumarate but it is likely a victim of interactions with rifampicin. We aimed to investigate the pharmacokinetics of tenofovir alafenamide/emtricitabine with rifampicin.
PATIENTS AND METHODS


Healthy volunteers received tenofovir alafenamide/emtricitabine at 25/200 mg once daily, followed by tenofovir alafenamide/emtricitabine + rifampicin daily followed by tenofovir disoproxil fumarate. Plasma tenofovir alafenamide, tenofovir, emtricitabine and intracellular tenofovir-DP and emtricitabine triphosphate pharmacokinetics and genetic polymorphisms were assessed.
RESULTS


Tenofovir alafenamide exposure decreased when tenofovir alafenamide/emtricitabine + rifampicin was used compared with tenofovir alafenamide/emtricitabine [geometric mean ratio (GMR) (90% CI): 0.45 (0.33-0.60)]. Plasma tenofovir and intracellular tenofovir-DP concentrations decreased with rifampicin [GMR (90% CI): 0.46 (0.40-0.52) and 0.64 (0.54-0.75), respectively]. GMR (90% CI) of intracellular tenofovir-DP AUC0-24 for tenofovir alafenamide/emtricitabine + rifampicin versus tenofovir disoproxil fumarate was 4.21 (2.98-5.95). Rifampicin did not affect emtricitabine pharmacokinetics. CYP3A4*22 rs35599367 was associated with higher plasma tenofovir alafenamide AUC0-24 at day 56.
CONCLUSIONS


Following tenofovir alafenamide/emtricitabine administration with rifampicin, intracellular tenofovir-DP concentrations were still 4.21-fold higher than those achieved by tenofovir disoproxil fumarate, supporting further study during HIV/TB co-infection.",2019,"Plasma tenofovir and intracellular tenofovir-DP concentrations decreased with rifampicin [GMR (90% CI): 0.46 (0.40-0.52) and 0.64 (0.54-0.75), respectively].",['Healthy volunteers'],"['tenofovir alafenamide/emtricitabine', 'CYP3A4', 'Rifampicin', 'rifampicin', 'Tenofovir alafenamide', 'tenofovir disoproxil fumarate', 'tenofovir alafenamide/emtricitabine + rifampicin daily followed by tenofovir disoproxil fumarate', 'rifampicin, intracellular tenofovir-DP concentrations', 'tenofovir alafenamide/emtricitabine with rifampicin', 'intracellular tenofovir-DP AUC0-24 for tenofovir alafenamide/emtricitabine + rifampicin versus tenofovir disoproxil fumarate']","['Plasma tenofovir alafenamide, tenofovir, emtricitabine and intracellular tenofovir-DP and emtricitabine triphosphate pharmacokinetics and genetic polymorphisms', 'GMR', 'Plasma tenofovir and intracellular tenofovir-DP concentrations', 'emtricitabine pharmacokinetics', 'tenofovir alafenamide/emtricitabine [geometric mean ratio (GMR', 'higher plasma tenofovir alafenamide AUC0', 'Tenofovir alafenamide exposure', 'intracellular and plasma pharmacokinetics of tenofovir alafenamide']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C3714798', 'cui_str': 'CYP3A4'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C0146894', 'cui_str': 'triphosphate'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0032529', 'cui_str': 'Polymorphism (Genetics)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",,0.0357761,"Plasma tenofovir and intracellular tenofovir-DP concentrations decreased with rifampicin [GMR (90% CI): 0.46 (0.40-0.52) and 0.64 (0.54-0.75), respectively].","[{'ForeName': 'Maddalena', 'Initials': 'M', 'LastName': 'Cerrone', 'Affiliation': ""St Stephen's AIDS Trust, Chelsea and Westminster Hospital, London, UK.""}, {'ForeName': 'Omamah', 'Initials': 'O', 'LastName': 'Alfarisi', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Neary', 'Affiliation': 'Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Marzinke', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Teresa L', 'Initials': 'TL', 'LastName': 'Parsons', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Owen', 'Affiliation': 'Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Maartens', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Pozniak', 'Affiliation': ""St Stephen's AIDS Trust, Chelsea and Westminster Hospital, London, UK.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Flexner', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Boffito', 'Affiliation': ""St Stephen's AIDS Trust, Chelsea and Westminster Hospital, London, UK.""}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz068']
1101,30859184,The pharmacokinetics of nitrofurantoin in healthy female volunteers: a randomized crossover study.,"BACKGROUND


Use of nitrofurantoin has increased significantly since its recent repositioning as a first-line agent for uncomplicated cystitis by multiple guidelines. However, current dosing regimens were developed in an era before robust pharmacokinetic testing and may not be optimal. Furthermore, formulations have been modified over the years.
OBJECTIVES


To reassess the plasma and urinary pharmacokinetic profile of macrocrystalline nitrofurantoin in two commonly used dosing regimens.
METHODS


In this open-label, randomized crossover pharmacokinetic trial, 12 healthy adult female volunteers were randomized to receive oral nitrofurantoin 100 mg q8h on days 1 and 2 and, after a washout period, 50 mg q6h on days 30 and 31, or the same dosing schemes in reversed order. Urine and blood were collected at steady state and analysed by UPLC. Pharmacokinetic analysis was performed by WinNonlin.
RESULTS


Plasma peak concentrations were low (mean 0.33 mg/L, SD 0.08, and 0.69 mg/L, SD 0.35, after 50 and 100 mg, respectively) and dose dependent. The AUC0-24 was higher (6.49 versus 4.43 mg·h/L, P = 0.021) for the 100 mg q8h dosing regimen, but the dose-normalized AUC was similar for the two regimens. In contrast, urinary concentrations were dose independent: increasing the nitrofurantoin dose delayed the time to peak urinary concentration, while steady-state AUC0-24 values remained unchanged (943.49 and 855.95 mg·h/L at 50 mg q6h and 100 mg q8h, respectively).
CONCLUSIONS


Plasma concentrations were relatively low and dose dependent. The dose-independent urinary concentrations suggest that excretion of nitrofurantoin into the urine is saturable. Pharmacodynamic studies are urgently required to determine the impact of these findings.",2019,"The AUC0-24 was higher (6.49 versus 4.43 mg·h/L, P = 0.021) for the 100 mg q8h dosing regimen, but the dose-normalized AUC was similar for the two regimens.","['healthy female volunteers', '12 healthy adult female volunteers']","['oral nitrofurantoin', 'nitrofurantoin']","['Plasma peak concentrations', 'urinary concentrations', 'Urine and blood']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0028156', 'cui_str': 'Nitrofurantoin'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0232827', 'cui_str': 'Urinary concentration, function (observable entity)'}, {'cui': 'C0042037'}, {'cui': 'C0005768'}]",12.0,0.0491764,"The AUC0-24 was higher (6.49 versus 4.43 mg·h/L, P = 0.021) for the 100 mg q8h dosing regimen, but the dose-normalized AUC was similar for the two regimens.","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Huttner', 'Affiliation': 'Division of Infectious Diseases, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Rixt A', 'Initials': 'RA', 'LastName': 'Wijma', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus University Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Stewardson', 'Affiliation': 'Department of Infectious Disease, Alfred Health and Central Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Flaminia', 'Initials': 'F', 'LastName': 'Olearo', 'Affiliation': 'Division of Infectious Diseases, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Von Dach', 'Affiliation': 'Division of Infectious Diseases, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Harbarth', 'Affiliation': 'Division of Infectious Diseases, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Roger J M', 'Initials': 'RJM', 'LastName': 'Brüggemann', 'Affiliation': 'Department of Pharmacy and Center of Expertise in Mycology, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Johan W', 'Initials': 'JW', 'LastName': 'Mouton', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus University Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Anouk E', 'Initials': 'AE', 'LastName': 'Muller', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus University Medical Centre, Rotterdam, The Netherlands.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz095']
1102,31094619,Does an Accelerated Program Give Equivalent Results in Both Elite Athletes and Nonathletes?,"CONTEXT


Although many researchers have investigated the functional outcomes of different accelerated rehabilitation programs after anterior cruciate ligament reconstruction (ACLR), the functional results of the same accelerated rehabilitation program following ACLR applied for both elite athletes and nonathletes have not yet been investigated.
OBJECTIVE


To examine the effects of the same accelerated anterior cruciate ligament rehabilitation program on pain and functionality of elite athletes and nonathletes.
DESIGN


Prospective preintervention-postintervention design.
SETTING


Physiotherapy department.
PARTICIPANTS


Fifteen elite athletes and 15 nonathletes who underwent unilateral ACLR with autologous hamstring tendon graft.
INTERVENTION


All participants received the same protocol for 6 weeks (5 sessions in a week).
MAIN OUTCOME MEASURES


Primary measurements were pain intensity, which was measured by visual analog scale, range of motion measurement using universal goniometer, and functionality, which was detected by Lysholm score. Secondary measurements were short form-36 and Beck Depression Inventory.
RESULTS


Higher Lysholm (P = .001) and Beck Depression Inventory (P = .03) scores were observed in the elite athlete group, and higher pain (P = .001) was observed in the nonathlete group at baseline assessments. Significant improvement detected for pain (P < .05), knee flexion range (P < .05), Lysholm score (P < .05), and Beck Depression Inventory (P < .05) compared with preintervention for both groups. Finally, after comparing the mean change values, the nonathlete group displayed greater decrease in pain level (P = .01) and participants in the elite athlete group further showed a greater decrease in depression level (P = .001).
CONCLUSIONS


This study found that the same accelerated rehabilitation protocol provides significant improvements for pain, functionality, and depression in both elite athletes and nonathletes after ACLR. Clinicians should consider our results when applying an anterior cruciate ligament rehabilitation program for nonathlete groups.",2019,"Significant improvement detected for pain (p<0.05), knee flexion range (p<0.05), Lysholm score (p<0.05) and BDI (p<0.05) compared to pre-intervention for both groups.","['anterior cruciate ligament reconstruction (ACLR', 'Physiotherapy department', 'elite athletes and non-athletes', '15 elite athletes and 15 non-athletes who underwent', 'elite athletes and non-athletes after ACLR']","['unilateral ACLR with autologous hamstring tendon graft', 'anterior cruciate ligament (ACL) rehabilitation program', 'ACL rehabilitation program']","['pain (p<0.05), knee flexion range (p<0.05), Lysholm score (p<0.05) and BDI', 'higher pain', 'pain, functionality and depression', 'SF-36 and Beck Depression Inventory (BDI', 'depression level', 'pain intensity which was measured by visual analogue scale, range of motion measurement using universal goniometer and functionality which was detected by Lysholm score', 'BDI ', 'pain and functionality', 'pain level']","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0587975', 'cui_str': 'Physiotherapy department (environment)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1279739', 'cui_str': 'Tendon transplantation (procedure)'}, {'cui': 'C0078960', 'cui_str': 'Anterior Cranial Cruciate Ligament'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",15.0,0.0261674,"Significant improvement detected for pain (p<0.05), knee flexion range (p<0.05), Lysholm score (p<0.05) and BDI (p<0.05) compared to pre-intervention for both groups.","[{'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Feyzioğlu', 'Affiliation': ''}, {'ForeName': 'Özgul', 'Initials': 'Ö', 'LastName': 'Öztürk', 'Affiliation': ''}, {'ForeName': 'Bilsen', 'Initials': 'B', 'LastName': 'Sirmen', 'Affiliation': ''}, {'ForeName': 'Selim', 'Initials': 'S', 'LastName': 'Muğrabi', 'Affiliation': ''}]",Journal of sport rehabilitation,['10.1123/jsr.2018-0346']
1103,31094639,The Effects of Blood Flow Restriction on Muscle Activation and Hypoxia in Individuals With Chronic Ankle Instability.,"CONTEXT


Muscle dysfunction is common in patients with chronic ankle instability (CAI). Blood flow restriction (BFR) may enhance muscle responses during exercise and provide an opportunity to enhance muscle adaptations to ankle rehabilitation exercises; however, there is no evidence examining the effect of BFR on muscle function in CAI patients.
OBJECTIVE


Examine the effects of BFR on muscle activation and oxygen saturation during submaximal ankle eversion and dorsiflexion exercises in individuals with CAI.
DESIGN


Cross-over study design.
SETTING


Laboratory setting. Patients (or Other Participants): Nineteen young adults with a history of CAI.
INTERVENTIONS


Participants performed 4 sets (30, 15, 15, and 15) of eversion and dorsiflexion resistance exercises at 30% of maximum voluntary isometric contraction during 2 conditions, BFR and control. For BFR, a cuff was applied above the knee at 80% of blood flow occlusion. For control, the cuff was not inflated.
MAIN OUTCOME MEASURES


Fibularis longus and tibialis anterior electromyography muscle activation, lower-leg muscle oxygen saturation, and ratings of perceived exertion were recorded during exercises.
RESULTS


Average grand mean muscle activation was 5.6% greater during eversion (P = .03) and 7.7% greater during dorsiflexion (P = .01) resistance exercises with BFR compared with control; however, the magnitudes of the effects of BFR were only clinically important during the dorsiflexion exercises. Lower-leg muscle oxygen saturation was 31% to 44% lower (P < .001) during BFR exercises. Ratings of perceived exertion were significantly higher during BFR exercises (P < .001).
CONCLUSIONS


Greater muscle activation and hypoxia were present during submaximal resistance exercise with BFR in participants with CAI. Greater muscle activation and hypoxia during BFR exercises may be important acute responses mediating the training-related muscle adaptations that have been observed with BFR. The presence of these acute responses in CAI patients supports further research examining BFR as a potential ankle rehabilitation tool.",2019,Lower-leg muscle oxygen saturation was 31-44% lower ( P <.001) during BFR exercises.,"['CAI patients', 'Individuals with Chronic Ankle Instability', '\n\n\nNineteen (n=19) young adults with a history of CAI', 'patients with chronic ankle instability (CAI', 'participants with CAI', 'individuals with CAI']","['eversion and dorsiflexion resistance exercises at 30% of maximum voluntary isometric contraction (MVIC', 'BFR', 'Blood Flow Restriction', 'Blood flow restriction (BFR']","['Lower-leg muscle oxygen saturation', 'Fibularis longus and tibialis anterior electromyography (EMG) muscle activation, lower-leg muscle oxygen saturation (SmO 2 ), and ratings of perceived exertion (RPE', 'RPE', 'muscle activation and oxygen saturation', 'mean muscle activation', 'Muscle Activation and Hypoxia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0015211', 'cui_str': 'Eversion (morphologic abnormality)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0022205', 'cui_str': 'Isometric Contraction'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}]","[{'cui': 'C1140621', 'cui_str': 'Leg'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]",,0.0162878,Lower-leg muscle oxygen saturation was 31-44% lower ( P <.001) during BFR exercises.,"[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Killinger', 'Affiliation': ''}, {'ForeName': 'Jakob D', 'Initials': 'JD', 'LastName': 'Lauver', 'Affiliation': ''}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Donovan', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Goetschius', 'Affiliation': ''}]",Journal of sport rehabilitation,['10.1123/jsr.2018-0416']
1104,31094640,Effects of Taping and Balance Exercises on Knee and Lower-Extremity Function in Amateur Soccer Players: A Randomized Controlled Trial.,"CONTEXT


Knee injury prevention is a critical aspect in sport rehabilitation sciences, and taping is a widely used technique in this field. Nevertheless, the role and effectiveness of a long-term application of Kinesio Taping (KT) on knee function, disability, and injury prevention remain unclear.
OBJECTIVE


To determine the effect of KT, alone or in combination with balance exercises (BE), on dynamic and static knee balance and flexibility.
DESIGN


Randomized trial design.
SETTING


University of Valencia (Spain).
PARTICIPANTS


Forty-eight male amateur soccer players.
INTERVENTION


Participants were assigned to 3 groups: Sham KT (sKT) + BE, KT + BE, and KT in isolation. The intervention period lasted 4 weeks. Three evaluations were performed: at baseline (pre), at 2 weeks (mid), and at 4 weeks posttreatment (post).
MAIN OUTCOME MEASURES


Y Balance Test, unipedal stance test, the toe touch test, and the Knee Injury and Osteoarthritis Outcome Score.
RESULTS


Both sKT + BE and KT + BE groups achieved significant pre-post improvements in SEBT, unipedal stance test, and toe touch test. The KT group only showed significant intragroup differences in the left and right unipedal stance test variable (P < .05, d = 0.76, d = 0.62, respectively). The sham KT group obtained the strongest results in all physical variables. Regarding the Knee Injury and Osteoarthritis Outcome Score, pre-post significant changes were found in the sham group (P < .05, d = 0.28).
CONCLUSIONS


Both sham and real KT in combination with BE achieved significant improvements on all physical variables, and these differences were significantly greater compared with those found in the KT in the isolation group, suggesting that benefits in knee function are due to the BE.
LEVEL OF EVIDENCE


Therapy level 1b.",2019,"Both sham and real KT in combination with BE achieved significant improvements on all physical variables, and these differences were significantly greater compared to those found in the KT in isolation group, suggesting that benefits in knee function are due to the BE.
","['Amateur Soccer Players', '48 male amateur soccer players', 'University of Valencia (Spain']","['Kinesio Taping, alone or in combination with balance exercises', 'Taping and Balance Exercises', 'Kinesio Taping', 'Sham KT (sKT) + BE; KT + BE']","['left and right UST variable', 'Y-Balance Test (YBT), Unipedal Stance Test (UST), the Toe Touch Test (TTT) and the Knee Injury and Osteoarthritis Outcome Score', 'Knee and Lower Extremity Function']","[{'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0040357', 'cui_str': 'Toes'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0031843', 'cui_str': 'function'}]",48.0,0.0502271,"Both sham and real KT in combination with BE achieved significant improvements on all physical variables, and these differences were significantly greater compared to those found in the KT in isolation group, suggesting that benefits in knee function are due to the BE.
","[{'ForeName': 'Gemma V', 'Initials': 'GV', 'LastName': 'Espí-López', 'Affiliation': ''}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Serra-Añó', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cobo-Pascual', 'Affiliation': ''}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Zarzoso', 'Affiliation': ''}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Suso-Martí', 'Affiliation': ''}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Cuenca-Martínez', 'Affiliation': ''}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Inglés', 'Affiliation': ''}]",Journal of sport rehabilitation,['10.1123/jsr.2018-0452']
1105,31748505,Effects of cannabidivarin (CBDV) on brain excitation and inhibition systems in adults with and without Autism Spectrum Disorder (ASD): a single dose trial during magnetic resonance spectroscopy.,"Autism spectrum disorder (ASD) is a high cost neurodevelopmental condition; and there are currently no effective pharmacological treatments for its core symptoms. This has led some families and researchers to trial alternative remedies - including the non-intoxicating Cannabis sativa-derived compound cannabidivarin (CBDV). However, how CBDV affects the human brain is unknown. Previous (pre)clinical evidence suggests that CBDV may modulate brain excitatory-inhibitory systems, which are implicated in ASD. Hence, our main aim was to test, for the first time, if CBDV shifts glutamate and/or GABA metabolites - markers of the brain's primary excitatory and inhibitory system - in both the 'typical' and autistic brain. Our subsidiary aim was to determine whether, within ASD, brain responsivity to CBDV challenge is related to baseline biological phenotype. We tested this using a repeated-measures, double-blind, randomized-order, cross-over design. We used magnetic resonance spectroscopy (MRS) to compare glutamate (Glx = glutamate + glutamine) and GABA + (GABA + macromolecules) levels following placebo (baseline) and 600 mg CBDV in 34 healthy men with (n = 17) and without (n = 17) ASD. Data acquisition from regions previously reliably linked to ASD (dorsomedial prefrontal cortex, DMPFC; left basal ganglia, BG) commenced 2 h (peak plasma levels) after placebo/CBDV administration. Where CBDV significantly shifted metabolite levels, we examined the relationship of this change with baseline metabolite levels. Test sessions were at least 13 days apart to ensure CBDV wash-out. CBDV significantly increased Glx in the BG of both groups. However, this impact was not uniform across individuals. In the ASD group, and not in the typically developing controls, the 'shift' in Glx correlated negatively with baseline Glx concentration. In contrast, CBDV had no significant impact on Glx in the DMPFC, or on GABA+ in either voxel in either group. Our findings suggest that, as measured by MRS, CBDV modulates the glutamate-GABA system in the BG but not in frontal regions. Moreover, there is individual variation in response depending on baseline biochemistry. Future studies should examine the effect of CBDV on behaviour and if the response to an acute dose of CBDV could predict a potential clinical treatment response in ASD.",2019,"In contrast, CBDV had no significant impact on Glx in the DMPFC, or on GABA+ in either voxel in either group.","['34 healthy men with (n\u2009=\u200917) and without (n\u2009=\u200917) ASD', 'adults with and without Autism Spectrum Disorder (ASD', 'Autism spectrum disorder (ASD']","['placebo (baseline) and 600\u2009mg CBDV', 'cannabidivarin (CBDV', 'magnetic resonance spectroscopy (MRS) to compare glutamate (Glx\u2009=\u2009glutamate\u2009+\u2009glutamine) and GABA\u2009+\u2009(GABA', 'magnetic resonance spectroscopy']",['brain excitation and inhibition systems'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3657549', 'cui_str': 'CBDV compound'}, {'cui': 'C0024487', 'cui_str': 'MR Spectroscopy'}, {'cui': 'C0220839', 'cui_str': 'Glutamate'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0016904', 'cui_str': 'gamma-Aminobutyric Acid'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",34.0,0.290473,"In contrast, CBDV had no significant impact on Glx in the DMPFC, or on GABA+ in either voxel in either group.","[{'ForeName': 'Charlotte M', 'Initials': 'CM', 'LastName': 'Pretzsch', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Bogdan', 'Initials': 'B', 'LastName': 'Voinescu', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lythgoe', 'Affiliation': ""Department of Neuroimaging Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Horder', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Maria Andreina', 'Initials': 'MA', 'LastName': 'Mendez', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wichers', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ajram', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Glynis', 'Initials': 'G', 'LastName': 'Ivin', 'Affiliation': 'South London and Maudsley NHS Foundation Trust Pharmacy, London, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Heasman', 'Affiliation': 'South London and Maudsley NHS Foundation Trust Pharmacy, London, UK.'}, {'ForeName': 'Richard A E', 'Initials': 'RAE', 'LastName': 'Edden', 'Affiliation': 'Russel H Morgan Department of Radiology and Radiological Science, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': ""Department of Neuroimaging Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Declan G M', 'Initials': 'DGM', 'LastName': 'Murphy', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Daly', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Gráinne M', 'Initials': 'GM', 'LastName': 'McAlonan', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK. grainne.mcalonan@kcl.ac.uk.""}]",Translational psychiatry,['10.1038/s41398-019-0654-8']
1106,31062373,Influence of Calcineurin Inhibitor and Sex on Mycophenolic Acid Pharmacokinetics and Adverse Effects Post-Renal Transplant.,"Tacrolimus or cyclosporine is prescribed with mycophenolic acid posttransplant and contributes to interpatient variability in mycophenolic acid pharmacokinetics and response. Cyclosporine inhibits enterohepatic circulation of the metabolite mycophenolic acid glucuronide, which is not described with tacrolimus. This study investigated mycophenolic acid pharmacokinetics and adverse effects in stable renal transplant recipients and the association with calcineurin inhibitors, sex, and race. Mycophenolic acid and mycophenolic acid glucuronide area under the concentration-time curve from 0 to 12 hours (AUC 0-12h  ) and apparent clearance were determined at steady state in 80 patients receiving cyclosporine with mycophenolate mofetil and 67 patients receiving tacrolimus with mycophenolate sodium. Gastrointestinal adverse effects and hematologic parameters were evaluated. Statistical models evaluated mycophenolic acid pharmacokinetics and adverse effects. Mycophenolic acid AUC 0-12h  was 1.70-fold greater with tacrolimus (68.9 ± 30.9 mg·h/L) relative to cyclosporine (40.8 ± 17.6 mg·h/L); P < .001. Target mycophenolic acid AUC 0-12h  of 30-60 mg·h/L was achieved in 56.3% on cyclosporine compared with 34.3% receiving tacrolimus (P < .001). Mycophenolic acid clearance was 48% slower with tacrolimus (10.6 ± 4.7 L/h) relative to cyclosporine (20.5 ± 10.0 L/h); P < .001. Enterohepatic circulation occurred less frequently with cyclosporine (45%) compared with tacrolimus (78%); P < 0.001; with a 2.9-fold greater mycophenolic acid glucuronide AUC 0-12h  to mycophenolic acid AUC 0-12h  ratio (P < .001). Race did not affect mycophenolic acid pharmacokinetics. Gastrointestinal adverse effect scores were 2.2-fold higher with tacrolimus (P < .001) and more prominent in women (P = .017). Lymphopenia was more prevalent with tacrolimus (52.2%) than cyclosporine (22.5%); P < 0.001. Calcineurin inhibitors and sex contributed to interpatient variability in mycophenolic acid pharmacokinetics and adverse effects post-renal transplant, which could be attributed to differences in enterohepatic circulation.",2019,Enterohepatic circulation occurred less frequently with cyclosporine (45%) compared with tacrolimus (78%); P < 0.001; with a 2.9-fold greater mycophenolic acid glucuronide AUC 0-12h  to mycophenolic acid AUC 0-12h  ratio (P ,"['stable renal transplant recipients', '80 patients receiving', '17.6']","['tacrolimus with mycophenolate sodium', 'Calcineurin Inhibitor', 'cyclosporine', 'Calcineurin inhibitors', 'tacrolimus', 'cyclosporine with mycophenolate mofetil', 'Mycophenolic acid and mycophenolic acid glucuronide', 'mycophenolic acid pharmacokinetics', 'Tacrolimus or cyclosporine', 'Mycophenolic acid AUC', 'Cyclosporine']","['Lymphopenia', 'Gastrointestinal adverse effects and hematologic parameters', 'mycophenolic acid pharmacokinetics and adverse effects', 'Mycophenolic acid clearance', 'Enterohepatic circulation', 'mycophenolic acid pharmacokinetics', 'Target mycophenolic acid AUC', 'Gastrointestinal adverse effect scores', 'mycophenolic acid glucuronide AUC']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C1337395', 'cui_str': 'mycophenolate sodium'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0676811', 'cui_str': 'mycophenolic acid 7-O-glucuronide'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]","[{'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0014362', 'cui_str': 'Entero-Hepatic Circulation'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0676811', 'cui_str': 'mycophenolic acid 7-O-glucuronide'}]",80.0,0.0689333,Enterohepatic circulation occurred less frequently with cyclosporine (45%) compared with tacrolimus (78%); P < 0.001; with a 2.9-fold greater mycophenolic acid glucuronide AUC 0-12h  to mycophenolic acid AUC 0-12h  ratio (P ,"[{'ForeName': 'Calvin J', 'Initials': 'CJ', 'LastName': 'Meaney', 'Affiliation': 'Immunosuppressive Pharmacology Research Program, Translational Pharmacology Research Core, Buffalo, NY, USA.'}, {'ForeName': 'Patcharaporn', 'Initials': 'P', 'LastName': 'Sudchada', 'Affiliation': 'Immunosuppressive Pharmacology Research Program, Translational Pharmacology Research Core, Buffalo, NY, USA.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Consiglio', 'Affiliation': 'Department of Biostatistics, School of Public Health and Health Professions, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Wilding', 'Affiliation': 'Department of Biostatistics, School of Public Health and Health Professions, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'Cooper', 'Affiliation': 'Immunosuppressive Pharmacology Research Program, Translational Pharmacology Research Core, Buffalo, NY, USA.'}, {'ForeName': 'Rocco C', 'Initials': 'RC', 'LastName': 'Venuto', 'Affiliation': 'Department of Medicine; Nephrology Division, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Tornatore', 'Affiliation': 'Immunosuppressive Pharmacology Research Program, Translational Pharmacology Research Core, Buffalo, NY, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1428']
1107,31177364,Conventional Versus Distal Laparoscopic One-Anastomosis Gastric Bypass: a Randomized Controlled Trial with 1-Year Follow-up.,"BACKGROUND


There is no consensus on the ideal small bowel length that should be bypassed in laparoscopic one-anastomosis gastric bypass (OAGB). This study aimed to compare the safety and efficacy of conventional versus distal techniques of laparoscopic OAGB.
METHODS


This randomized controlled trial involved 60 adults with morbid obesity scheduled for laparoscopic OAGB randomly assigned to one of the two techniques; conventional technique (fixed anastomosis 200 cm from the ligament of Treitz) and distal technique (anastomosis 400 cm from the ileocecal valve). Total small bowel length (TSBL) was measured in all cases. Quality of life was assessed using the Gastrointestinal Quality of Life Index (GIQLI). Outcome measures were excess body weight loss percentage (EBWL%), resolution of associated comorbidities, frequency of nutritional deficiencies, and quality of life.
RESULTS


No patients were lost to follow-up. The two groups were comparable in TSBL, EBWL%, and complete resolution of comorbidities up to 12 months. The percentage of afferent loop length to TSBL was significantly higher in the distal group (p < 0.001) but was not correlated with EBWL%. The levels of hemoglobin, cholesterol, triglycerides, iron, and albumin were significantly lower and parathormone hormone was higher in the distal group. The GIQLI score was significantly higher in the conventional group during follow-up.
CONCLUSION


OAGB achieves optimum results when the afferent loop length is 200 cm; bypassing more than 200 cm does not improve weight loss or comorbidity resolution. Measuring TSBL is recommended to avoid excessive small bowel shortening that increases the risk of nutritional consequences.",2019,The percentage of afferent loop length to TSBL was significantly higher in the distal group (p < 0.001) but was not correlated with EBWL%.,['60 adults with morbid obesity scheduled for laparoscopic OAGB randomly assigned to one of the two techniques'],"['Conventional Versus Distal Laparoscopic One-Anastomosis Gastric Bypass', 'conventional technique (fixed anastomosis 200\xa0cm from the ligament of Treitz) and distal technique (anastomosis 400\xa0cm from the ileocecal valve']","['safety and efficacy', 'percentage of afferent loop length to TSBL', 'Quality of life', 'weight loss or comorbidity resolution', 'Total small bowel length (TSBL', 'TSBL, EBWL%, and complete resolution of comorbidities', 'parathormone hormone', 'Gastrointestinal Quality of Life Index (GIQLI', 'excess body weight loss percentage (EBWL%), resolution of associated comorbidities, frequency of nutritional deficiencies, and quality of life', 'levels of hemoglobin, cholesterol, triglycerides, iron, and albumin', 'GIQLI score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1261087', 'cui_str': 'Ligament of Treitz'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0020880', 'cui_str': 'Ileocecal Valve'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205115', 'cui_str': 'Afferent (qualifier value)'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0034380'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index (assessment scale)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",60.0,0.0909236,The percentage of afferent loop length to TSBL was significantly higher in the distal group (p < 0.001) but was not correlated with EBWL%.,"[{'ForeName': 'Tamer M', 'Initials': 'TM', 'LastName': 'Nabil', 'Affiliation': 'Department of General Surgery, Beni Suef University, Beni Suef, Egypt.'}, {'ForeName': 'Ahmed H', 'Initials': 'AH', 'LastName': 'Khalil', 'Affiliation': 'Department of General Surgery, Cairo University, Fom El Khalig, Cairo, Egypt. dr_ahmedhussein76@yahoo.com.'}, {'ForeName': 'Sameh', 'Initials': 'S', 'LastName': 'Mikhail', 'Affiliation': 'Department of General Surgery, Cairo University, Fom El Khalig, Cairo, Egypt.'}, {'ForeName': 'Salah S', 'Initials': 'SS', 'LastName': 'Soliman', 'Affiliation': 'Department of General Surgery, Fayoum University, Faiyum, Egypt.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Aziz', 'Affiliation': 'Department of General Surgery, Cairo University, Fom El Khalig, Cairo, Egypt.'}, {'ForeName': 'Halepian', 'Initials': 'H', 'LastName': 'Antoine', 'Affiliation': 'Department of General Surgery, Cairo University, Fom El Khalig, Cairo, Egypt.'}]",Obesity surgery,['10.1007/s11695-019-03991-5']
1108,31590926,Pharmacist linkage in care transitions: From academic medical center to community.,"OBJECTIVES


To improve the care of patients discharged from the University of Mississippi Medical Center (UMMC) after treatment for acute myocardial infarction, heart failure, pneumonia, and chronic obstructive pulmonary disease; reduce preventable hospital readmissions; and inform future care transition collaborations between hospital teams and community pharmacies.
SETTING


Study was conducted at UMMC, UMMC outpatient pharmacies, and targeted community pharmacies.
PRACTICE DESCRIPTION


UMMC is the state's only academic health science center, providing all levels of care. Participants were at UMMC's 722-bed hospital in Jackson, MS. Participating pharmacies included 2 UMMC outpatient pharmacies and community pharmacy research partner sites within 60 miles of UMMC.
PRACTICE INNOVATION


A pharmacist transitions coordinator (PTC) worked with inpatient and community-based pharmacists to provide predischarge medication reconciliation and 30 days of medications on discharge. The PTC with access to inpatient and outpatient records facilitated communication among settings/providers. Community pharmacists provided telephonic and face-to-face medication therapy management (MTM).
EVALUATION


The project was structured as a prospective, randomized controlled trial of pharmacist-led care coordination during transition from inpatient to community setting, with follow-up MTM by community pharmacists. In this intention-to-treat analysis, readmission rates were assessed with propensity adjustment. Drug therapy problems (DTPs) identified/resolved were assessed and reported through descriptive statistics.
RESULTS


Ninety-six patients were enrolled. Positive outcomes in overall reduced readmission rates were observed in the intervention group at 30, 60, 90, and 180 days, although statistical significance was not achieved because of limited enrollment. Approximately 60% participated in MTM postdischarge, with 453 interventions and 169 DTPs identified and addressed (98% > 1 DTP; 20% > 5 DTPs). Implementation experience includes PTC successes, new partnerships, and connectivity among all providers, as well as enrollment challenges, follow-up, and service delivery timeframe.
CONCLUSION


With access to patient records, pharmacists have the potential to positively affect patient outcomes through medication management during care transitions.",2019,"Positive outcomes in overall reduced readmission rates were observed in the intervention group at 30, 60, 90, and 180 days, although statistical significance was not achieved because of limited enrollment.","['Participating pharmacies included 2 UMMC outpatient pharmacies and community pharmacy research partner sites within 60 miles of UMMC', ""Participants were at UMMC's 722-bed hospital in Jackson, MS"", 'Study was conducted at UMMC, UMMC outpatient pharmacies, and targeted community pharmacies', 'Ninety-six patients were enrolled', 'patients discharged from the University of Mississippi Medical Center (UMMC) after treatment for acute myocardial infarction, heart failure, pneumonia, and chronic obstructive pulmonary disease']",['UMMC'],['readmission rates'],"[{'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0035168'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0331865', 'cui_str': 'Mile (qualifier value)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030685', 'cui_str': 'Patient Discharge'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0026221', 'cui_str': 'Mississippi'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]",[],[],96.0,0.0436658,"Positive outcomes in overall reduced readmission rates were observed in the intervention group at 30, 60, 90, and 180 days, although statistical significance was not achieved because of limited enrollment.","[{'ForeName': 'Lauren S', 'Initials': 'LS', 'LastName': 'Bloodworth', 'Affiliation': ''}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Malinowski', 'Affiliation': ''}, {'ForeName': 'Seth T', 'Initials': 'ST', 'LastName': 'Lirette', 'Affiliation': ''}, {'ForeName': 'Leigh Ann', 'Initials': 'LA', 'LastName': 'Ross', 'Affiliation': ''}]",Journal of the American Pharmacists Association : JAPhA,['10.1016/j.japh.2019.08.011']
1109,31062459,MRI-Based Radiomics Signature for the Preoperative Prediction of Extracapsular Extension of Prostate Cancer.,"BACKGROUND


Radiomics approaches based on multiparametric MRI (mp-MRI) have shown high accuracy in prostate cancer (PCa) management. However, there is a need to apply radiomics to the preoperative prediction of extracapsular extension (ECE).
PURPOSE


To develop and validate a radiomics signature to preoperatively predict the probability of ECE for patients with PCa, compared with the radiologists' interpretations.
STUDY TYPE


Retrospective.
POPULATION


In total, 210 patients with pathology-confirmed ECE status (101 positive, 109 negative) were enrolled.
FIELD STRENGTH/SEQUENCE


T 2  -weighted imaging (T 2  WI), diffusion-weighted imaging, and dynamic contrast-enhanced imaging were performed on two 3.0T MR scanners.
ASSESSMENT


A radiomics signature was constructed to predict the probability of ECE prior to radical prostatectomy (RP). In all, 17 stable radiomics features of 1619 extracted features based on T 2  WI were selected. The same images were also evaluated by three radiologists. The predictive performance of the radiomics signature was validated and compared with radiologists' interpretations.
STATISTICAL TESTS


A radiomics signature was developed by a least absolute shrinkage and selection operator (LASSO) regression algorithm. Samples enrolled were randomly divided into two groups (143 for training and 67 for validation). Discrimination, calibration, and clinical usefulness were validated by analysis of the receiver operating characteristic (ROC) curve, calibration curve, and the decision curve, respectively. The predictive performance was then compared with visual assessments of three radiologists.
RESULTS


The radiomics signature yielded an AUC of 0.902 and 0.883 in the training and validation cohort, respectively, and outperformed the visual assessment (AUC: 0.600-0.697) in the validation cohort. Pairwise comparisons demonstrated that the radiomics signature was more sensitive than the radiologists (75.00% vs. 46.88%-50.00%, all P < 0.05), but obtained comparable specificities (91.43% vs. (88.57%-94.29%); P ranged from 0.64-1.00).
DATA CONCLUSION


A radiomics signature was developed and validated that outperformed the radiologists' visual assessments in predicting ECE status.
LEVEL OF EVIDENCE


4 Technical Efficacy Stage: 2 J. Magn. Reson. Imaging 2019;50:1914-1925.",2019,"The radiomics signature yielded an AUC of 0.902 and 0.883 in the training and validation cohort, respectively, and outperformed the visual assessment (AUC: 0.600-0.697) in the validation cohort.","['210 patients with pathology-confirmed ECE status (101 positive, 109 negative) were enrolled', 'patients with PCa', 'T 2  -weighted', '17 stable radiomics features of 1619 extracted features based on T 2  WI were selected']",[],['probability of ECE prior to radical prostatectomy (RP'],"[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",[],"[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]",210.0,0.025447,"The radiomics signature yielded an AUC of 0.902 and 0.883 in the training and validation cohort, respectively, and outperformed the visual assessment (AUC: 0.600-0.697) in the validation cohort.","[{'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'Department of Radiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Huihui', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Department of Radiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Huihui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Department of Radiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Jiejin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Radiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Lin', 'Affiliation': 'Department of Radiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Peking University First Hospital and Institute of Urology, Peking University, Beijing, China.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': 'Department of Urology, Peking University First Hospital and Institute of Urology, Peking University, Beijing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yingpu', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Radiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Peking University First Hospital, Beijing, China.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.26777']
1110,31086947,"Efficacy, Safety, and Immunogenicity of an Escherichia coli-Produced Bivalent Human Papillomavirus Vaccine: An Interim Analysis of a Randomized Clinical Trial.","BACKGROUND


The high cost and insufficient supply of human papillomavirus (HPV) vaccines have slowed the pace of controlling cervical cancer. A phase III clinical trial was conducted to evaluate the efficacy, safety, and immunogenicity of a novel Escherichia coli-produced bivalent HPV-16/18 vaccine.
METHODS


A multicenter, randomized, double-blind trial started on November 22, 2012 in China. In total, 7372 eligible women aged 18-45 years were age-stratified and randomly assigned to receive three doses of the test or control (hepatitis E) vaccine at months 0, 1, and 6. Co-primary endpoints included high-grade genital lesions and persistent infection (over 6 months) associated with HPV-16/18. The primary analysis was performed on a per-protocol susceptible population of individuals who were negative for relevant HPV type-specific neutralizing antibodies (at day 0) and DNA (at day 0 through month 7) and who received three doses of the vaccine. This report presents data from a prespecified interim analysis used for regulatory submission.
RESULTS


In the per-protocol cohort, the efficacies against high-grade genital lesions and persistent infection were 100.0% (95% confidence interval = 55.6% to 100.0%, 0 of 3306 in the vaccine group vs 10 of 3296 in the control group) and 97.8% (95% confidence interval = 87.1% to 99.9%, 1 of 3240 vs 45 of 3246), respectively. The side effects were mild. No vaccine-related serious adverse events were noted. Robust antibody responses for both types were induced and persisted for at least 42 months.
CONCLUSIONS


The E coli-produced HPV-16/18 vaccine is well tolerated and highly efficacious against HPV-16/18-associated high-grade genital lesions and persistent infection in women.",2020,The Escherichia coli-produced HPV-16/18 vaccine is well tolerated and highly efficacious against HPV-16/18 associated high-grade genital lesions and persistent infection in women.,"['7372 eligible women aged 18-45 years were age-stratified', 'November 22, 2012, in China']","['novel Escherichia coli-produced bivalent HPV-16/18 vaccine', 'Escherichia coli-produced bivalent human papillomavirus vaccine', 'test or control (hepatitis E) vaccine', 'vaccine']","['efficacy, safety and immunogenicity', 'efficacies against high-grade genital lesions and persistent infection', 'Efficacy, safety, and immunogenicity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0085293', 'cui_str': 'Hepatitis, Water-Borne'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0744369', 'cui_str': 'Lesion of genitalia'}, {'cui': 'C1264606', 'cui_str': 'Persistent infection'}]",7372.0,0.594263,The Escherichia coli-produced HPV-16/18 vaccine is well tolerated and highly efficacious against HPV-16/18 associated high-grade genital lesions and persistent infection in women.,"[{'ForeName': 'You-Lin', 'Initials': 'YL', 'LastName': 'Qiao', 'Affiliation': 'National Cancer Center, National Center for Cancer Clinical Research, The Cancer Institute, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'Rong-Cheng', 'Initials': 'RC', 'LastName': 'Li', 'Affiliation': 'Guangxi Center for Disease Control and Prevention, Nanning, Guangxi, China.'}, {'ForeName': 'Yue-Mei', 'Initials': 'YM', 'LastName': 'Hu', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China.'}, {'ForeName': 'Li-Hui', 'Initials': 'LH', 'LastName': 'Wei', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Chang-Gui', 'Initials': 'CG', 'LastName': 'Li', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'National Cancer Center, National Center for Cancer Clinical Research, The Cancer Institute, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shou-Jie', 'Initials': 'SJ', 'LastName': 'Huang', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'Fang-Hui', 'Initials': 'FH', 'LastName': 'Zhao', 'Affiliation': 'National Cancer Center, National Center for Cancer Clinical Research, The Cancer Institute, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ming-Qiang', 'Initials': 'MQ', 'LastName': 'Li', 'Affiliation': 'Liuzhou Center for Disease Control and Prevention, Liuzhou, Guangxi, China.'}, {'ForeName': 'Qin-Jing', 'Initials': 'QJ', 'LastName': 'Pan', 'Affiliation': 'National Cancer Center, National Center for Cancer Clinical Research, The Cancer Institute, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'National Cancer Center, National Center for Cancer Clinical Research, The Cancer Institute, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Shenzhen Maternity and Child Healthcare Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Hong', 'Affiliation': 'The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Wen-Hua', 'Initials': 'WH', 'LastName': 'Zhang', 'Affiliation': 'National Cancer Center, National Center for Cancer Clinical Research, The Cancer Institute, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yan-Ping', 'Initials': 'YP', 'LastName': 'Li', 'Affiliation': 'Guangxi Center for Disease Control and Prevention, Nanning, Guangxi, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Chu', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yun-Fei', 'Initials': 'YF', 'LastName': 'Jiang', 'Affiliation': 'The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Zhi-Jie', 'Initials': 'ZJ', 'LastName': 'Lin', 'Affiliation': 'Xiamen Innovax Biotech Company, Xiamen, Fujian, China.'}, {'ForeName': 'Xue-Lian', 'Initials': 'XL', 'LastName': 'Cui', 'Affiliation': 'Liuzhou Center for Disease Control and Prevention, Liuzhou, Guangxi, China.'}, {'ForeName': 'Wen-Yu', 'Initials': 'WY', 'LastName': 'Liu', 'Affiliation': 'Funing Center for Disease Control and Prevention, Funing, Jiangsu, China.'}, {'ForeName': 'Cai-Hong', 'Initials': 'CH', 'LastName': 'Li', 'Affiliation': 'Xinmi Maternal and Child Health Hospital, Xinmi, Henan, China.'}, {'ForeName': 'Dong-Ping', 'Initials': 'DP', 'LastName': 'Guo', 'Affiliation': 'Yangcheng Maternal and Child Health Hospital, Yangcheng, Shanxi, China.'}, {'ForeName': 'Li-Dong', 'Initials': 'LD', 'LastName': 'Ke', 'Affiliation': 'Fengning Hospital of Traditional Chinese Medicine, Fengning, Hebei, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Liuzhou Center for Disease Control and Prevention, Liuzhou, Guangxi, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Funing Center for Disease Control and Prevention, Funing, Jiangsu, China.'}, {'ForeName': 'Guo-Qi', 'Initials': 'GQ', 'LastName': 'Gao', 'Affiliation': 'Xinmi Maternal and Child Health Hospital, Xinmi, Henan, China.'}, {'ForeName': 'Ba-Yi', 'Initials': 'BY', 'LastName': 'Li', 'Affiliation': 'Yangcheng Maternal and Child Health Hospital, Yangcheng, Shanxi, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Fengning Hospital of Traditional Chinese Medicine, Fengning, Hebei, China.'}, {'ForeName': 'Feng-Xian', 'Initials': 'FX', 'LastName': 'Zheng', 'Affiliation': 'Xinmi Maternal and Child Health Hospital, Xinmi, Henan, China.'}, {'ForeName': 'Cui-Hong', 'Initials': 'CH', 'LastName': 'Dai', 'Affiliation': 'Fengning Hospital of Traditional Chinese Medicine, Fengning, Hebei, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'Ying-Ying', 'Initials': 'YY', 'LastName': 'Su', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'Jun-Zhi', 'Initials': 'JZ', 'LastName': 'Wang', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Feng-Cai', 'Initials': 'FC', 'LastName': 'Zhu', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China.'}, {'ForeName': 'Shao-Wei', 'Initials': 'SW', 'LastName': 'Li', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'Hui-Rong', 'Initials': 'HR', 'LastName': 'Pan', 'Affiliation': 'Xiamen Innovax Biotech Company, Xiamen, Fujian, China.'}, {'ForeName': 'Yi-Min', 'Initials': 'YM', 'LastName': 'Li', 'Affiliation': 'Xiamen Innovax Biotech Company, Xiamen, Fujian, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'Ning-Shao', 'Initials': 'NS', 'LastName': 'Xia', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China.'}]",Journal of the National Cancer Institute,['10.1093/jnci/djz074']
1111,31067489,Mnemonic strategy training increases neocortical activation in healthy older adults and patients with mild cognitive impairment.,"Learning and memory deficits characterize the diagnosis of amnestic mild cognitive impairment (aMCI), which is widely viewed as a clinical precursor to Alzheimer's type dementia. There is a growing interest in non-pharmacologic interventions, such as mnemonic strategies, for improving learning and memory in patients with aMCI as well as for maintaining functioning in healthy older adults. Using an ecologically relevant object-location association paradigm, we conducted a randomized, controlled, single-blind study in which healthy older adults and patients with aMCI were randomized to either mnemonic strategy training or a control group that was matched for stimulus exposure. We previously reported that mnemonic strategy training resulted in significantly greater learning and memory improvements compared to the matched exposure condition, in both aMCI patients and healthy controls. The current study examined changes in neocortical activation during encoding in a subset of participants who underwent functional magnetic resonance imaging (fMRI) scanning both before and after training. To minimize potential confounds in between-group comparisons, we employed non-linear cortex based alignment and included only correctly encoded stimuli in our analyses. When re-encoding stimuli learned during training (i.e., trained stimuli), we found a general enhancement of activation in right prefrontal and parietal regions, possibly reflecting practice-related improvement in coordinate spatial processing in all but the aMCI exposure group. Left hemisphere activation was typically only evident in the mnemonic strategy trained participants, regardless of diagnostic status, with the ventrolateral prefrontal cortex appearing especially important for strategy use. While encoding relatively novel stimuli, both mnemonic strategy groups (aMCI patients and healthy controls) demonstrated increased activation in a subset of regions showing change for the trained stimuli, indicating a mnemonic strategy-induced change in the processing of new information. These findings could not be explained by repeated exposure since there was little to no activation overlap in the respective exposure control groups. The current results reinforce the potential benefits of cognitive interventions in these growing populations and indicate that neuroplastic change in key rostral and lateral prefrontal regions mediate this behavioral change.",2019,"There is a growing interest in non-pharmacologic interventions, such as mnemonic strategies, for improving learning and memory in patients with aMCI as well as for maintaining functioning in healthy older adults.","['amnestic mild cognitive impairment (aMCI', 'healthy older adults and patients with mild cognitive impairment', 'healthy older adults', 'healthy older adults and patients with aMCI']","['mnemonic strategy training', 'Mnemonic strategy training', 'functional magnetic resonance imaging (fMRI) scanning']","['neocortical activation', 'learning and memory improvements', 'Left hemisphere activation']","[{'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0589105', 'cui_str': 'Strategy training (regime/therapy)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}]",,0.0213011,"There is a growing interest in non-pharmacologic interventions, such as mnemonic strategies, for improving learning and memory in patients with aMCI as well as for maintaining functioning in healthy older adults.","[{'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Hampstead', 'Affiliation': 'Mental Health Service, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America; Neuropsychology Section, Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States of America; Department of Rehabilitation Medicine, Emory University, Atlanta, GA, United States of America. Electronic address: bhampste@med.umich.edu.'}, {'ForeName': 'Anthony Y', 'Initials': 'AY', 'LastName': 'Stringer', 'Affiliation': 'Department of Rehabilitation Medicine, Emory University, Atlanta, GA, United States of America; Department of Psychology, Emory University, Atlanta, GA, United States of America.'}, {'ForeName': 'Randall F', 'Initials': 'RF', 'LastName': 'Stilla', 'Affiliation': 'Department of Neurology, Emory University, Atlanta, GA, United States of America.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sathian', 'Affiliation': 'Department of Rehabilitation Medicine, Emory University, Atlanta, GA, United States of America; Department of Neurology, Emory University, Atlanta, GA, United States of America; Department of Psychology, Emory University, Atlanta, GA, United States of America; Departments of Neurology, Neural & Behavioral Sciences, and Psychology, Pennsylvania State University, Hershey, PA, United States of America.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2019.04.011']
1112,30954691,Bolus therapy with 3% hypertonic saline or 0.9% saline in emergency department patients with suspected sepsis: A pilot randomised controlled trial.,"OBJECTIVE AND DESIGN


Hypertonic saline administered during fluid resuscitation may mitigate endothelial glycocalyx (EG) shedding and inflammation. The objective of this pilot randomised controlled trial was to measure the effect of hypertonic saline, compared to isotonic saline, on biomarkers of EG shedding and inflammation in emergency department patients with suspected sepsis.
METHODS


Patients received either 5 mL/kg of 3% saline (hypertonic group, n = 34) or 10 mL/kg of 0.9% saline (isotonic group, n = 31). Change in serum biomarker concentrations of syndecan-1, hyaluronan, intercellular adhesion molecule-1, vascular cell adhesion molecule-1, interleukin-6, -8, -10, interferon-γ, neutrophil gelatinase-associated lipocalin and resistin were compared from baseline (T0) to after fluid (T1), 3 h (T3) and 12-24 h (T24) later, as was serum osmolality, using linear mixed effects models.
RESULTS


The hypertonic group had significantly increased mean serum osmolality compared to the isotonic group at T1 (P < .001) and T3 (P = .004). Minor differences were found in some biomarker outcomes, including a decreased fold-change in syndecan-1 at T1 (P = .012) and in interleukin-10 at T24 (P = .006) in the isotonic group, compared to the hypertonic group.
CONCLUSIONS


Although a single bolus of hypertonic saline increased serum osmolality, it did not reduce biomarkers of EG shedding or inflammation, compared to patients that received isotonic saline.
TRIAL REGISTRATION


ANZCTR.org.au, ACTRN12611001021965, Registered on 23rd September 2011.",2019,"Change in serum biomarker concentrations of syndecan-1, hyaluronan, intercellular adhesion molecule-1, vascular cell adhesion molecule-1, interleukin-6, -8, -10, interferon-γ, neutrophil gelatinase-associated lipocalin and resistin were compared from baseline (T0) to after fluid (T1), 3 h (T3) and 12-24 h (T24) later, as was serum osmolality, using linear mixed effects models.
","['Patients received either', 'emergency department patients with suspected sepsis']","['5\u202fmL/kg of 3% saline (hypertonic group, n\u202f=\u202f34) or 10\u202fmL/kg of 0.9% saline (isotonic', 'hypertonic saline', 'hypertonic saline or 0.9% saline', 'isotonic saline']","['serum biomarker concentrations of syndecan-1, hyaluronan, intercellular adhesion molecule-1, vascular cell adhesion molecule-1, interleukin-6, -8, -10, interferon-γ, neutrophil gelatinase-associated lipocalin and resistin', 'serum osmolality', 'mean serum osmolality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}]","[{'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1609943', 'cui_str': 'CD138 Antigens'}, {'cui': 'C0813622', 'cui_str': 'Hyaluronan'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206528', 'cui_str': 'Gelatinases'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}, {'cui': 'C0963992', 'cui_str': 'Adipocyte Cysteine-Rich Secreted Protein FIZZ3'}, {'cui': 'C0202151', 'cui_str': 'Osmolality measurement, serum (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.483211,"Change in serum biomarker concentrations of syndecan-1, hyaluronan, intercellular adhesion molecule-1, vascular cell adhesion molecule-1, interleukin-6, -8, -10, interferon-γ, neutrophil gelatinase-associated lipocalin and resistin were compared from baseline (T0) to after fluid (T1), 3 h (T3) and 12-24 h (T24) later, as was serum osmolality, using linear mixed effects models.
","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Smart', 'Affiliation': 'Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, Perth, Australia; Emergency Medicine, University of Western Australia, Perth, Australia; Comparative Health Research Group, School of Veterinary Medicine, Murdoch University, Perth, Australia. Electronic address: Lisa.smart@research.uwa.edu.au.'}, {'ForeName': 'Stephen P J', 'Initials': 'SPJ', 'LastName': 'Macdonald', 'Affiliation': 'Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, Perth, Australia; Emergency Medicine, University of Western Australia, Perth, Australia; Emergency Department, Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Bosio', 'Affiliation': 'Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, Perth, Australia; Emergency Medicine, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fatovich', 'Affiliation': 'Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, Perth, Australia; Emergency Medicine, University of Western Australia, Perth, Australia; Emergency Department, Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Neil', 'Affiliation': 'Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, Perth, Australia; Emergency Medicine, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Arendts', 'Affiliation': 'Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, Perth, Australia; Emergency Medicine, University of Western Australia, Perth, Australia; Emergency Department, Fiona Stanley Hospital, Perth, Australia.'}]",Journal of critical care,['10.1016/j.jcrc.2019.03.009']
1113,32410657,OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the emergency department: chest X-ray or ultra-low-dose chest CT (OPTIMACT) trial-statistical analysis plan.,"BACKGROUND


A chest X-ray is a standard imaging procedure in the diagnostic work-up of patients suspected of having non-traumatic pulmonary disease. Compared to a chest X-ray, an ultra-low-dose (ULD) chest computed tomography (CT) scan provides substantially more detailed information on pulmonary conditions. To what extent this translates into an improvement in patient outcomes and health care efficiency is yet unknown. The OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the emergency department: chest X-ray or ultra-low-dose chest CT (OPTIMACT) study is a multicenter, pragmatic, non-inferiority randomized controlled trial designed to evaluate replacement of chest X-ray by ULD chest CT in the diagnostic work-up of such patients, in terms of patient-related health outcomes and costs. During randomly assigned periods of 1 calendar month, either conventional chest X-ray or ULD chest CT scan was used as the imaging strategy. This paper presents in detail the statistical analysis plan of the OPTIMACT trial, developed prior to data analysis.
METHODS/RESULTS


Functional health at 28 days is the primary clinical outcome. Functional health at 28 days is measured by the physical component summary scale of the Short Form (SF)-12 questionnaire version 1. Secondary outcomes are mental health (mental component summary scale of the SF-12), length of hospital stay, mortality within 28 days, quality-adjusted life year equivalent during the first 28 days (derived from the EuroQol five-dimension, five-level instrument), correct diagnoses at emergency department discharge as compared to the final post hoc diagnosis at day 28, number of patients in follow-up because of incidental findings on chest X-ray or ULD chest CT, and health care costs.
CONCLUSIONS


After this pragmatic trial we will have precise estimates of the effectiveness of replacing chest X-ray with ULD chest CT in terms of patient-related health outcomes and costs.
TRIAL REGISTRATION


Netherlands National Trial Register: NTR6163. Registered on 6 December 2016.",2020,Functional health at 28 days is measured by the physical component summary scale of the Short Form (SF)-12 questionnaire version 1.,"['patients suspected of having non-traumatic pulmonary disease', 'patients suspected of non-traumatic pulmonary disease at the emergency department']","['replacing chest X-ray with ULD chest CT', 'chest X-ray by ULD chest CT', 'ultra-low-dose (ULD) chest computed tomography (CT) scan', 'conventional chest X-ray or ULD chest CT scan', 'chest X-ray or ultra-low-dose chest CT']","['Functional health', 'mental health (mental component summary scale of the SF-12), length of hospital stay, mortality within 28\u2009days, quality-adjusted life year equivalent during the first 28\u2009days (derived from the EuroQol five-dimension, five-level instrument), correct diagnoses at emergency department discharge']","[{'cui': 'C0522483', 'cui_str': 'Patient suspected of'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]","[{'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C4075962', 'cui_str': 'Low dose computed tomography of thorax'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",,0.0871583,Functional health at 28 days is measured by the physical component summary scale of the Short Form (SF)-12 questionnaire version 1.,"[{'ForeName': 'Maadrika M N P', 'Initials': 'MMNP', 'LastName': 'Kanglie', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, location AMC, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, the Netherlands. m.m.kanglie@amsterdamumc.nl.'}, {'ForeName': 'Shandra', 'Initials': 'S', 'LastName': 'Bipat', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, location AMC, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, the Netherlands.'}, {'ForeName': 'Inge A H', 'Initials': 'IAH', 'LastName': 'van den Berk', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, location AMC, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, the Netherlands.'}, {'ForeName': 'Tjitske S R', 'Initials': 'TSR', 'LastName': 'van Engelen', 'Affiliation': 'Center of Experimental and Molecular Medicine, Amsterdam UMC, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, the Netherlands.'}, {'ForeName': 'Marcel G W', 'Initials': 'MGW', 'LastName': 'Dijkgraaf', 'Affiliation': 'Department of Clinical Epidemiology, Biostatics and Bioinformatics, Amsterdam UMC, location AMC, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, the Netherlands.'}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'Prins', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, the Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Stoker', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, location AMC, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, the Netherlands.'}, {'ForeName': 'Patrick M M', 'Initials': 'PMM', 'LastName': 'Bossuyt', 'Affiliation': 'Department of Clinical Epidemiology, Biostatics and Bioinformatics, Amsterdam UMC, location AMC, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, the Netherlands.'}]",Trials,['10.1186/s13063-020-04343-w']
1114,31021358,"Effects of 12 Weeks of Essential Amino Acids (EAA)-Based Multi-Ingredient Nutritional Supplementation on Muscle Mass, Muscle Strength, Muscle Power and Fatigue in Healthy Elderly Subjects: A Randomized Controlled Double-Blind Study.","OBJECTIVE


To counteract muscle mass, muscle strength and power loss during aging, and to study age-related change of neuromuscular manifestation of fatigue in relation to nutritional supplementation.
DESIGN


randomized controlled double-blind study.
SETTING


Twice-daily consumption for 12 weeks of an Essential Amino Acids (EAA)-based multi-ingredient nutritional supplement containing EAA, creatine, vitamin D and Muscle Restore Complex®.
PARTICIPANTS


38 healthy elderly subjects (8 male, 30 female; age: 68.91±4.60 years; body weight: 69.40±15.58 kg; height: 1.60±0.09 m) were randomized and allocated in supplement (SUPP) or placebo (PLA) group. Mean Measurements: Vitamin D blood level; Appendicular Lean Mass (ALM); Visceral Adipose Tissue (VAT); Maximal Voluntary Contraction (MVC) and Peak Power (PP); myoelectric descriptors of fatigue: Fractal Dimension and Conduction Velocity initial values (FD iv, CV iv), their rates of change (FD slopes, CV slopes) and the Time to perform the Task (TtT). Mean Results: Significant changes were found in SUPP compared to baseline: Vitamin D (+8.73 ng/ml; p<0.001); ALM (+0.34 kg; p<0.001); VAT (-76.25 g; p<0.001); MVC (+0.52 kg; p<0.001); PP (+4.82 W; p<0.001). Between group analysis (SUPP Vs. PLA) showed improvements: vitamin D blood levels (+11,72 ng/ml; p<0.001); Legs FFM (+443.7 g; p<0.05); ALM (+0.53 kg; p<0.05); MVC (+1.38 kg; p<0.05); PP (+9.87 W; p<0.05). No statistical changes were found for FD iv, CV iv, FD and CV slopes and TtT, either compared to baseline or between groups. Significant correlations between mean differences in SUPP group were also found.
CONCLUSION


The study demonstrates that in healthy elderly subjects an EAA-based multi-ingredient nutritional supplementation of 12 weeks is not effective to change myoelectric manifestation of fatigue and TtT failure but can positively affect muscle mass, muscle strength, muscle power and VAT, counterbalancing more than one year of age-related loss of muscle mass and strength.",2019,"PLA) showed improvements: vitamin D blood levels (+11,72 ng/ml; p<0.001); Legs FFM (+443.7 g; p<0.05); ALM (+0.53 kg; p<0.05); MVC (+1.38 kg; p<0.05); PP (+9.87 W; p<0.05).","['38 healthy elderly subjects (8 male, 30 female; age: 68.91±4.60 years; body weight: 69.40±15.58 kg; height: 1.60±0.09 m', 'Healthy Elderly Subjects', 'healthy elderly subjects']","['Essential Amino Acids (EAA)-based multi-ingredient nutritional supplement containing EAA, creatine, vitamin D and Muscle Restore Complex®', 'Essential Amino Acids (EAA)-Based Multi-Ingredient Nutritional Supplementation', 'supplement (SUPP) or placebo (PLA', 'PLA']","['Legs FFM', 'SUPP', 'improvements: vitamin D blood levels', 'Mean Measurements: Vitamin D blood level; Appendicular Lean Mass (ALM); Visceral Adipose Tissue (VAT); Maximal Voluntary Contraction (MVC) and Peak Power (PP); myoelectric descriptors of fatigue: Fractal Dimension and Conduction Velocity initial values (FD iv, CV iv), their rates of change (FD slopes, CV slopes) and the Time to perform the Task (TtT', 'FD iv, CV iv, FD and CV slopes and TtT', 'Muscle Mass, Muscle Strength, Muscle Power and Fatigue']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]","[{'cui': 'C0002525', 'cui_str': 'Amino Acids, Essential'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0282354', 'cui_str': 'Descriptors'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0206163', 'cui_str': 'Fractals'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0234084', 'cui_str': 'Conduction rate of nerve cell and nerve fiber, function (observable entity)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}]",38.0,0.230669,"PLA) showed improvements: vitamin D blood levels (+11,72 ng/ml; p<0.001); Legs FFM (+443.7 g; p<0.05); ALM (+0.53 kg; p<0.05); MVC (+1.38 kg; p<0.05); PP (+9.87 W; p<0.05).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Negro', 'Affiliation': ""Giuseppe D'Antona, CRIAMS-Sport Medicine Centre, University of Pavia, Voghera, Italy, gdantona@unipv.it.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Perna', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Spadaccini', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Castelli', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Calanni', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Barbero', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cescon', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rondanelli', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': ""D'Antona"", 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-019-1163-4']
1115,31075459,Design of the PReferences for Open Versus Endovascular Repair of Abdominal Aortic Aneurysm (PROVE-AAA) Trial.,"For patients with abdominal aortic aneurysm (AAA), randomized trials have found endovascular AAA repair (EVAR) is associated with lower perioperative morbidity and mortality than open surgical repair (OSR). However, OSR has fewer long-term aneurysm-related complications, such as endoleak or late rupture. Patients treated with EVAR and OSR have similar survival rates within two years after surgery, and OSR does not require intensive surveillance. Few have examined if patient preferences are aligned with the type of treatment they receive for their AAA. Although many assume that patients may universally prefer the less-invasive nature of EVAR, our preliminary work suggests that patients who value the lower risk of late complications may prefer OSR. In this study, called The PReferences for Open Versus Endovascular Repair of Abdominal Aortic Aneurysm (PROVE-AAA) trial, we describe a cluster-randomized trial to test if a decision aid can better align patients' preferences and their treatment type for AAA. Patients enrolled in the study are candidates for either endovascular or open repair and are followed up at VA hospitals by vascular surgery teams who regularly perform both types of repair. In Aim 1, we will determine patients' preferences for endovascular or open repair and identify domains associated with each repair type. In Aim 2, we will assess alignment between patients' preferences and the repair type elected and then compare the impact of a decision aid on this alignment between the intervention and control groups. This study will help us to accomplish two goals. First, we will better understand the factors that affect patient preference when choosing between EVAR and OSR. Second, we will better understand if a decision aid can help patients be more likely to receive the treatment strategy they prefer for their AAA. Study enrollment began on June 1, 2017. Between June 1, 2017 and November 1, 2018, we have enrolled 178 of a total goal of 240 veterans from 20 VA medical centers and their vascular surgery teams across the country. We anticipate completing enrollment in PROVE-AAA in June 2019, and study analyses will be performed thereafter.",2020,"Patients treated with EVAR and OSR have similar survival rates within two years following surgery, and OSR does not require intensive surveillance.","['Patients enrolled in the study are candidates for either endovascular or open repair, and are followed at VA hospitals by vascular surgery teams who regularly perform both types of repair', 'Between June 1, 2017 and November 1, 2018, we have enrolled 178 of a total goal of 240 Veterans from 20 VA Medical Centers and their vascular surgery teams across the country', 'patients with abdominal aortic aneurysm', ""patients' preferences for endovascular or open repair and identify domains associated with each repair type""]","['endovascular AAA repair (EVAR', 'EVAR and OSR']",['survival rates'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C3714645', 'cui_str': 'Vascular surgery'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0449521', 'cui_str': 'Type of repair (attribute)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0162871', 'cui_str': 'Aortic Aneurysm, Abdominal'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.15694,"Patients treated with EVAR and OSR have similar survival rates within two years following surgery, and OSR does not require intensive surveillance.","[{'ForeName': 'Jesse A', 'Initials': 'JA', 'LastName': 'Columbo', 'Affiliation': 'Department of Surgery and VA Outcomes Group, White River Junction VA Medical Center, White River Junction, VT.'}, {'ForeName': 'Ravinder', 'Initials': 'R', 'LastName': 'Kang', 'Affiliation': 'Department of Surgery and VA Outcomes Group, White River Junction VA Medical Center, White River Junction, VT.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Spangler', 'Affiliation': 'Department of Vascular Surgery, Birmingham VA Medical Center, Birmingham, AL.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Newhall', 'Affiliation': 'Department of Surgery and VA Outcomes Group, White River Junction VA Medical Center, White River Junction, VT.'}, {'ForeName': 'Benjamin S', 'Initials': 'BS', 'LastName': 'Brooke', 'Affiliation': 'Department of Vascular Surgery, George E. Wahlen Department of Veterans Affairs Medical Center, Salt Lake City, UT.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Dosluoglu', 'Affiliation': 'Department of Vascular Surgery, Buffalo VA Medical Center, Buffalo, NY.'}, {'ForeName': 'Eugene S', 'Initials': 'ES', 'LastName': 'Lee', 'Affiliation': 'Department of Vascular Surgery, Sacramento VA Medical Center, Mather, CA.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Raffetto', 'Affiliation': 'Department of Vascular Surgery, West Roxbury VA Medical Center, West Roxbury, MA.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Henke', 'Affiliation': 'Department of Vascular Surgery, VA Ann Arbor Healthcare System, Ann Arbor, MI.'}, {'ForeName': 'Gale S', 'Initials': 'GS', 'LastName': 'Tang', 'Affiliation': 'Department of Vascular Surgery, VA Puget Sound Health Care System, Seattle, WA.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Mureebe', 'Affiliation': 'Department of Vascular Surgery, Durham VA Health Care System, Durham, NC.'}, {'ForeName': 'Panagoitis', 'Initials': 'P', 'LastName': 'Kougias', 'Affiliation': 'Department of Vascular Surgery, Michael E. DeBakey VA Medical Center, Houston, TX.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Johanning', 'Affiliation': 'Department of Vascular Surgery, Omaha VA Medical Center-VA Nebraska-Western Iowa HCS, Omaha, NE.'}, {'ForeName': 'Shipra', 'Initials': 'S', 'LastName': 'Arya', 'Affiliation': 'Department of Vascular Surgery, Atlanta VA Medical Center, Decatur, GA.'}, {'ForeName': 'Salvatore T', 'Initials': 'ST', 'LastName': 'Scali', 'Affiliation': 'Department of Vascular Surgery, Malcom Randall VA Medical Center, Gainesville, FL.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Stone', 'Affiliation': 'Department of Surgery and VA Outcomes Group, White River Junction VA Medical Center, White River Junction, VT.'}, {'ForeName': 'Bjoern D', 'Initials': 'BD', 'LastName': 'Suckow', 'Affiliation': 'Department of Surgery and VA Outcomes Group, White River Junction VA Medical Center, White River Junction, VT.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Orion', 'Affiliation': 'Department of Vascular Surgery, West Haven VA Medical Center, West Haven, CT.'}, {'ForeName': 'Vivienne', 'Initials': 'V', 'LastName': 'Halpern', 'Affiliation': 'Department of Vascular Surgery, Phoenix VA Health Care System, Phoenix, AZ.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': ""O'Connell"", 'Affiliation': 'Department of Vascular Surgery, West Los Angeles Medical Center, Los Angeles, CA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Inhat', 'Affiliation': 'Department of Vascular Surgery, Minneapolis VA Health Care System, Minneapolis, MN.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nelson', 'Affiliation': ""Department of Vascular Surgery, James A. Haley Veterans' Hospital, Tampa, FL.""}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Tzeng', 'Affiliation': 'Department of Vascular Surgery, VA Pittsburg Healthcare System, Pittsburg, PA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Department of Vascular Surgery, Southern Arizona VA Health Care System, Tucson, AZ.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Barry', 'Affiliation': 'Massachusetts General Hospital Center for Shared Decision Making, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Sirovich', 'Affiliation': 'Department of Surgery and VA Outcomes Group, White River Junction VA Medical Center, White River Junction, VT.'}, {'ForeName': 'Philip P', 'Initials': 'PP', 'LastName': 'Goodney', 'Affiliation': 'Department of Surgery and VA Outcomes Group, White River Junction VA Medical Center, White River Junction, VT. Electronic address: Philip.goodney@hitchcock.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of vascular surgery,['10.1016/j.avsg.2019.02.034']
1116,30207423,A behaviour change intervention with lipid-based nutrient supplements had little impact on young child feeding indicators in rural Kenya.,"Poor infant and young child feeding (IYCF) practices are associated with linear growth faltering. Our objective was to evaluate the impact of a nutrition and water and sanitation for health intervention on three IYCF indicators-minimum dietary diversity (MDD), minimum meal frequency (MMF), and minimum acceptable diet (MAD) in Kenyan children. Households were randomized into one of eight groups: (a) active control; (b) passive control; (c) water quality (W); (d) sanitation (S); (e) handwashing (H); (f) combined Water, Sanitation, and Handwashing; (g) nutrition (N); and (h) combined WSH + N. In the N and WSH + N arms, community-based promoters counselled households on optimal IYCF practices, and small-quantity lipid-based nutrient supplements (SQ-LNS) were provided to children 6-24 months of age. Twelve months (Year 1) and 24 months (Year 2) after interventions began, enumerators surveyed mothers to ascertain IYCF practices. We made pairwise comparisons of each intervention arm versus the active control arm using log binomial models. In total, 3,652 caretakers were surveyed at Year 1 and 4,987 caretakers at Year 2. Compared with the active control, there were no differences in any of the arms in MDD, MMF, or MAD, aside from an increase in MDD at Year 1 in the nutrition only arm but not in the combined WSH + N arm (N: 68%; WSH + N: 61%; C: 61%; N arm prevalence ratio: 1.13 95% CI [1.01, 1.25]). In this setting, a nutrition behaviour change communication intervention had little impact on IYCF indicators. The provision of SQ-LNS was not detrimental to current IYCF indicators in the community.",2019,"Compared with the active control, there were no differences in any of the arms in MDD, MMF, or MAD, aside from an increase in MDD at Year 1 in the nutrition only arm but not in the combined WSH ","['3,652 caretakers were surveyed at Year 1 and 4,987 caretakers at Year 2', 'young child feeding indicators in rural Kenya', 'Kenyan children']","['active control; (b) passive control; (c) water quality (W); (d) sanitation (S); (e) handwashing (H); (f) combined Water, Sanitation, and Handwashing; (g) nutrition (N); and (h) combined WSH\xa0+\xa0N', 'lipid-based nutrient supplements', 'nutrition and water and sanitation for health intervention']","['IYCF indicators-minimum dietary diversity (MDD), minimum meal frequency (MMF), and minimum acceptable diet (MAD', 'MDD, MMF, or MAD, aside from an increase in MDD']","[{'cui': 'C0335350', 'cui_str': 'Building caretaker'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0337839', 'cui_str': 'Kenyans (ethnic group)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0597680', 'cui_str': 'Water Quality'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0671759', 'cui_str': 'MAD'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",3652.0,0.0701926,"Compared with the active control, there were no differences in any of the arms in MDD, MMF, or MAD, aside from an increase in MDD at Year 1 in the nutrition only arm but not in the combined WSH ","[{'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Byrd', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, California.'}, {'ForeName': 'Holly N', 'Initials': 'HN', 'LastName': 'Dentz', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, California.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': 'Department of Global Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Kiprotich', 'Affiliation': 'Innovations for Poverty Action, Kakamega, Kenya.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Pickering', 'Affiliation': 'Department of Civil and Environmental Engineering, Tufts University, Medford, Massachusetts.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Omondi', 'Affiliation': 'Center for International Policy Research, Mathematica Policy Research, Washington, District of Columbia.'}, {'ForeName': 'Osborne', 'Initials': 'O', 'LastName': 'Kwena', 'Affiliation': 'Center for International Policy Research, Mathematica Policy Research, Washington, District of Columbia.'}, {'ForeName': 'Gouthami', 'Initials': 'G', 'LastName': 'Rao', 'Affiliation': 'Innovations for Poverty Action, Kakamega, Kenya.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, California.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Arnold', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health, University of California Berkeley, Berkeley, California.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, California.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Colford', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health, University of California Berkeley, Berkeley, California.'}, {'ForeName': 'Clair', 'Initials': 'C', 'LastName': 'Null', 'Affiliation': 'Innovations for Poverty Action, Kakamega, Kenya.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Stewart', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, California.'}]",Maternal & child nutrition,['10.1111/mcn.12660']
1117,31609774,Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients: The VANCS II Randomized Clinical Trial.,"OBJECTIVES


Previous trials suggest that vasopressin may improve outcomes in patients with vasodilatory shock. The aim of this study was to evaluate whether vasopressin could be superior to norepinephrine to improve outcomes in cancer patients with septic shock.
DESIGN


Single-center, randomized, double-blind clinical trial, and meta-analysis of randomized trials.
SETTING


ICU of a tertiary care hospital.
PATIENTS


Two-hundred fifty patients 18 years old or older with cancer and septic shock.
INTERVENTIONS


Patients were assigned to either vasopressin or norepinephrine as first-line vasopressor therapy. An updated meta-analysis was also conducted including randomized trials published until October 2018.
MEASUREMENTS AND MAIN RESULTS


The primary outcome was all-cause mortality at 28 days after randomization. Prespecified secondary outcomes included 90-days all-cause mortality rate; number of days alive and free of advanced organ support at day 28; and Sequential Organ Failure Assessment score 24 hours and 96 hours after randomization. We also measure the prevalence of adverse effects in 28 days. A total of 250 patients were randomized. The primary outcome was observed in 71 patients (56.8%) in the vasopressin group and 66 patients (52.8%) in the norepinephrine group (p = 0.52). There were no significant differences in 90-day mortality (90 patients [72.0%] and 94 patients [75.2%], respectively; p = 0.56), number of days alive and free of advanced organ support, adverse events, or Sequential Organ Failure Assessment score.
CONCLUSIONS


In cancer patients with septic shock, vasopressin as first-line vasopressor therapy was not superior to norepinephrine in reducing 28-day mortality rate.",2019,"There were no significant differences in 90-day mortality (90 patients [72.0%] and 94 patients [75.2%], respectively; p = 0.56), number of days alive and free of advanced organ support, adverse events, or Sequential Organ Failure Assessment score.
","['Cancer Patients', 'patients with vasodilatory shock', 'cancer patients with septic shock', 'Two-hundred fifty patients 18 years old or older with cancer and septic shock', '250 patients were randomized', 'ICU of a tertiary care hospital']","['vasopressin or norepinephrine', 'norepinephrine', 'Vasopressin Versus Norepinephrine', 'vasopressin']","['28-day mortality rate', '90-days all-cause mortality rate; number of days alive and free of advanced organ support at day 28; and Sequential Organ Failure Assessment score', 'number of days alive and free of advanced organ support, adverse events, or Sequential Organ Failure Assessment score', '90-day mortality', 'cause mortality', 'prevalence of adverse effects']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}]","[{'cui': 'C0201849', 'cui_str': 'Antidiuretic hormone measurement (procedure)'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C3494459', 'cui_str': 'SOFAS Scores'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",250.0,0.621102,"There were no significant differences in 90-day mortality (90 patients [72.0%] and 94 patients [75.2%], respectively; p = 0.56), number of days alive and free of advanced organ support, adverse events, or Sequential Organ Failure Assessment score.
","[{'ForeName': 'Ludhmila Abrahão', 'Initials': 'LA', 'LastName': 'Hajjar', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cristiane', 'Initials': 'C', 'LastName': 'Zambolim', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Belletti', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Juliano Pinheiro', 'Initials': 'JP', 'LastName': 'de Almeida', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Gordon', 'Affiliation': 'Section of Anaesthetics, Pain Medicine and Intensive Care, Faculty of Medicine, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Gisele', 'Initials': 'G', 'LastName': 'Oliveira', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Clarice Hyesuk Lee', 'Initials': 'CHL', 'LastName': 'Park', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Julia Tizue', 'Initials': 'JT', 'LastName': 'Fukushima', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Stephanie Itala', 'Initials': 'SI', 'LastName': 'Rizk', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Tais Felix', 'Initials': 'TF', 'LastName': 'Szeles', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Nestor Cordeiro', 'Initials': 'NC', 'LastName': 'Dos Santos Neto', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Roberto Kalil', 'Initials': 'RK', 'LastName': 'Filho', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Filomena Regina Barbosa Gomes', 'Initials': 'FRBG', 'LastName': 'Galas', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}]",Critical care medicine,['10.1097/CCM.0000000000004023']
1118,30986760,The hospital-based evaluation of laxative prophylaxis in ICU (HELP-ICU): A pilot cluster-crossover randomized clinical trial.,"PURPOSE


Prophylactic laxative regimens may prevent constipation but may increase diarrhea and subsequent rectal tube insertion. Our aim was to compare three prophylactic laxative regimens on the rate of rectal tube insertion (primary outcome) and major constipation- or diarrhea-associated complications.
MATERIAL AND METHODS


We conducted a cluster-crossover trial. Three pods in a single ICU were each randomized to one of three regimens for four months with rolling cross-over. All mechanically-ventilated and enterally-fed adult patients received either regimen: A) one coloxyl with senna BD from day one; B) two coloxyl with senna +20 ml lactulose BD commencing on day 3; or C) two coloxyl with senna tablets +20 ml lactulose BD commencing on day 6.
RESULTS


We enrolled 570 patients (A = 170, B = 205, C = 195) with similar baseline features. Overall, 53 (9.3%) patients received a rectal tube, and insertion rate was not statistically different between the three regimens (A = 12.9%, B = 7.8%, C = 7.7%; p = 0.15). The proportions of patients with other major constipation- or diarrhea-associated complications were similar, as were major patient-centred outcomes.
CONCLUSION


Earlier commencement of a prophylactic coloxyl-based laxative regimen (day 1 or 3) did not affect the rates of complications associated with constipation or diarrhea when compared to delayed introduction (day 6).",2019,"Overall, 53 (9.3%) patients received a rectal tube, and insertion rate was not statistically different between the three regimens (A = 12.9%, B = 7.8%, C = 7.7%; p = 0.15).","['We enrolled 570 patients (A\u202f=\u202f170, B\u202f=\u202f205, C\u202f=\u202f195) with similar baseline features']","['coloxyl with senna +20\u202fml lactulose BD', 'coloxyl with senna tablets +20\u202fml lactulose BD', 'prophylactic coloxyl-based laxative regimen']","['diarrhea-associated complications', 'rate of rectal tube insertion (primary outcome) and major constipation- or diarrhea-associated complications', 'rates of complications associated with constipation or diarrhea', 'rectal tube, and insertion rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C3489575', 'cui_str': 'sennosides, USP'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0282090', 'cui_str': 'Laxatives'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0178099', 'cui_str': 'Insertion of tube into rectum (procedure)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]",570.0,0.141363,"Overall, 53 (9.3%) patients received a rectal tube, and insertion rate was not statistically different between the three regimens (A = 12.9%, B = 7.8%, C = 7.7%; p = 0.15).","[{'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Hay', 'Affiliation': 'The University of Melbourne, Melbourne Medical School, Parkville, Victoria, Australia.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Deane', 'Affiliation': 'The University of Melbourne, Melbourne Medical School, Department of Medicine and Radiology, Royal Melbourne Hospital, Parkville, VIC 3050, Australia; Intensive Care Unit, The Royal Melbourne Hospital, Parkville, Victoria, Australia. Electronic address: adam.deane@mh.org.au.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Rechnitzer', 'Affiliation': 'Intensive Care Unit, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Fetterplace', 'Affiliation': 'The University of Melbourne, Melbourne Medical School, Department of Medicine and Radiology, Royal Melbourne Hospital, Parkville, VIC 3050, Australia; Intensive Care Unit, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Reilly', 'Affiliation': 'Intensive Care Unit, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Ankravs', 'Affiliation': 'The University of Melbourne, Melbourne Medical School, Department of Medicine and Radiology, Royal Melbourne Hospital, Parkville, VIC 3050, Australia; Intensive Care Unit, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, Melbourne, Australia; The University of Melbourne, Department of Medicine and Radiology, Parkville, Victoria, Australia.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Fazio', 'Affiliation': 'The University of Melbourne, Melbourne Medical School, Department of Medicine and Radiology, Royal Melbourne Hospital, Parkville, VIC 3050, Australia; Business Intelligence Unit, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Anstey', 'Affiliation': 'The University of Melbourne, Melbourne Medical School, Department of Medicine and Radiology, Royal Melbourne Hospital, Parkville, VIC 3050, Australia; Intensive Care Unit, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': ""D'Costa"", 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, Melbourne, Australia.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Presneill', 'Affiliation': 'The University of Melbourne, Melbourne Medical School, Department of Medicine and Radiology, Royal Melbourne Hospital, Parkville, VIC 3050, Australia; Intensive Care Unit, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'MacIsaac', 'Affiliation': 'The University of Melbourne, Melbourne Medical School, Department of Medicine and Radiology, Royal Melbourne Hospital, Parkville, VIC 3050, Australia; Intensive Care Unit, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'The University of Melbourne, Melbourne Medical School, Department of Medicine and Radiology, Royal Melbourne Hospital, Parkville, VIC 3050, Australia; Intensive Care Unit, The Royal Melbourne Hospital, Parkville, Victoria, Australia; Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, Melbourne, Australia; Intensive Care Unit, The Austin Hospital, Heidelberg, Victoria, Australia.'}]",Journal of critical care,['10.1016/j.jcrc.2019.04.010']
1119,31083052,Moderators of Response to Cognitive Behavior Therapy for Major Depression in Patients With Heart Failure.,"OBJECTIVE


Although cognitive behavior therapy (CBT) is efficacious for major depression in patients with heart failure (HF), approximately half of patients do not remit after CBT. To identify treatment moderators that may help guide treatment allocation strategies and serve as new treatment targets, we performed a secondary analysis of a randomized clinical trial. Based on evidence of their prognostic relevance, we evaluated whether clinical and activity characteristics moderate the effects of CBT.
METHODS


Participants were randomized to enhanced usual care (UC) alone or CBT plus enhanced UC. The single-blinded outcomes were 6-month changes in Beck Depression Inventory total scores and remission (defined as a Beck Depression Inventory ≤ 9). Actigraphy was used to assess daily physical activity patterns. We performed analyses to identify the specific activity and clinical moderators of the effects of CBT in 94 adults (mean age = 58, 49% female) with HF and major depressive disorder.
RESULTS


Patients benefited more from CBT (versus UC) if they had the following: more medically severe HF (i.e., a higher New York Heart Association class or a lower left ventricular ejection fraction), more stable activity patterns, wider active periods, and later evening settling times. These individual moderator effects were small (|r| = 0.10-0.21), but combining the moderators yielded a medium moderator effect size (r = 0.38; 95% CI = 0.20-0.52).
CONCLUSIONS


These findings suggest that increasing the cross-daily stability of activity patterns, and prolonging the daily active period, might help increase the efficacy of CBT. Given moderating effects of HF severity measures, research is also needed to clarify and address factors in patients with less severe HF that diminish the efficacy of CBT.
CLINICAL TRIAL REGISTRATION


clinicaltrials.gov identifier: NCT01028625.",2019,"These individual moderator effects were small (|r| = 0.10-0.21), but combining the moderators yielded a medium moderator effect size (r = 0.38; 95% CI = 0.20-0.52).
","['patients with heart failure (HF', 'patients with less severe HF', 'Patients With Heart Failure', '94 adults (mean age = 58, 49% female) with HF and major depressive disorder', 'Participants']","['cognitive behavior therapy (CBT', 'Cognitive Behavior Therapy', 'enhanced usual care (UC) alone or CBT plus enhanced UC', 'CBT']","['daily physical activity patterns', 'Beck Depression Inventory total scores and remission (defined as a Beck Depression Inventory ≤ 9']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}]",,0.103956,"These individual moderator effects were small (|r| = 0.10-0.21), but combining the moderators yielded a medium moderator effect size (r = 0.38; 95% CI = 0.20-0.52).
","[{'ForeName': 'Stephen F', 'Initials': 'SF', 'LastName': 'Smagula', 'Affiliation': 'From the Department of Psychiatry (Smagula, Wallace), School of Medicine, University of Pittsburgh; Department of Epidemiology (Smagula), Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA; Department of Psychiatry (Freedland, Steinmeyer, R.M. Carney), Washington University School of Medicine; and Division of Cardiology (M.W. Carney), Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Freedland', 'Affiliation': ''}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Steinmeyer', 'Affiliation': ''}, {'ForeName': 'Meredith J', 'Initials': 'MJ', 'LastName': 'Wallace', 'Affiliation': ''}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Carney', 'Affiliation': ''}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Rich', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000712']
1120,31074184,Acetazolamide to increase natriuresis in congestive heart failure at high risk for diuretic resistance.,"AIMS


To investigate the effects of acetazolamide on natriuresis, decongestion, kidney function and neurohumoral activation in acute heart failure (AHF).
METHODS AND RESULTS


This prospective, two-centre study included 34 AHF patients on loop diuretics with volume overload. All had a serum sodium concentration < 135 mmol/L and/or serum urea/creatinine ratio > 50 and/or an admission serum creatinine increase of > 0.3 mg/dL compared to baseline. Patients were randomised towards acetazolamide 250-500 mg daily plus bumetanide 1-2 mg bid vs. high-dose loop diuretics (bumetanide bid with daily dose twice the oral maintenance dose). The primary endpoint was natriuresis after 24 h. Natriuresis after 24 h was similar in the combinational treatment vs. loop diuretic only arm (264 ± 126 vs. 234 ± 133 mmol; P = 0.515). Loop diuretic efficiency, defined as natriuresis corrected for loop diuretic dose, was higher in the group receiving acetazolamide (84 ± 46 vs. 52 ± 42 mmol/mg bumetanide; P = 0.048). More patients in the combinational treatment arm had an increase in serum creatinine levels > 0.3 mg/dL (P = 0.046). N-terminal pro-B-type natriuretic peptide reduction and peak neurohumoral activation within 72 h were comparable among treatment arms. There was a non-significant trend towards lower all-cause mortality or heart failure readmissions in the group receiving acetazolamide with low-dose loop diuretics vs. high-dose loop diuretic monotherapy (P = 0.098).
CONCLUSION


Addition of acetazolamide increases the natriuretic response to loop diuretics compared to an increase in loop diuretic dose in AHF at high risk for diuretic resistance.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01973335.",2019,"There was a non-significant trend towards lower all-cause mortality or heart failure readmissions in the group receiving acetazolamide with low-dose loop diuretics vs. high-dose loop diuretic monotherapy (P = 0.098).
","['acute heart failure (AHF', 'congestive heart failure at high risk for diuretic resistance', '34 AHF patients on loop diuretics with volume overload']","['bumetanide', 'acetazolamide 250-500\u2009mg daily plus bumetanide', 'Acetazolamide', 'acetazolamide', 'loop diuretics (bumetanide']","['natriuresis, decongestion, kidney function and neurohumoral activation', 'natriuretic response', 'serum sodium concentration', 'cause mortality or heart failure readmissions', 'natriuresis after 24\u2009h. Natriuresis', 'serum creatinine levels ']","[{'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0354100', 'cui_str': 'Loop Diuretics'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia (disorder)'}]","[{'cui': 'C0006376', 'cui_str': 'Bumetanide'}, {'cui': 'C0000981', 'cui_str': 'Acetazolamide'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}]","[{'cui': 'C0027477', 'cui_str': 'Natriuresis'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0600061', 'cui_str': 'Serum creatinine level - finding'}]",34.0,0.257808,"There was a non-significant trend towards lower all-cause mortality or heart failure readmissions in the group receiving acetazolamide with low-dose loop diuretics vs. high-dose loop diuretic monotherapy (P = 0.098).
","[{'ForeName': 'Frederik H', 'Initials': 'FH', 'LastName': 'Verbrugge', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Martens', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Ameloot', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Haemels', 'Affiliation': 'Department of Cardiovascular Medicine, UZ Leuven, Leuven, Belgium.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Penders', 'Affiliation': 'Department of Laboratory Medicine, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Dupont', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Wai Hong Wilson', 'Initials': 'WHW', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Droogné', 'Affiliation': 'Department of Cardiovascular Medicine, UZ Leuven, Leuven, Belgium.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Mullens', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}]",European journal of heart failure,['10.1002/ejhf.1478']
1121,31736279,Comparison of macular buckling and vitrectomy for the treatment of macular schisis and associated macular detachment in high myopia: a randomized clinical trial.,"OBJECTIVE


To compare the efficacy and safety of macular buckling and vitrectomy for myopic traction maculopathy showing macular schisis (MS) and associated macular detachment (MD) but without full-thickness macular hole (FTMH).
DESIGN


Prospective, randomized, parallel, open-label study.
METHODS


Patients were randomly assigned to either buckling or vitrectomy group. Macular buckling and intravitreal C3F8 gas injection were performed in the buckling group. Small gauge vitrectomy, internal limiting membrane peeling (ILMP) and C3F8 gas tamponade were performed in the vitrectomy group. The patients were followed for 12 months.
MAIN OUTCOME MEASURES


Best-corrected visual acuity (BCVA) at 12 months.
RESULTS


A total of 85 patients were randomized, 80 eyes were included (41 receiving buckling, 39 received vitrectomy), and 78 patients completed the study. There were less eyes determined as surgical failure and required a second surgery in the buckling group than vitrectomy the group (2.4% versus 18.4%, p = 0.021). After surgery, macular buckling achieved more improvement in BCVA (+21.7 versus +4.5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, p = 0.002). FTMH development was observed in only 1 (2.4%) eye, after removing of the implant due to recurrent conjunctival erosion, in the buckling group and 10 (26.3%) eyes (seven with-, three without MD) in the vitrectomy group (p < 0.001). More eyes developed cataracts in the vitrectomy group than did in the buckling group (28.9% versus 7.5%, p = 0.014). Macular buckling-associated strabismus (esotropia), binocular diplopia and implant exposure were observed in limited cases.
CONCLUSIONS AND RELEVANCE


Macular buckling is superior to vitrectomy with ILM peeling plus gas injection for surgical treatment of MS and associated MD in high myopia.",2020,"There were less eyes determined as surgical failure and required a second surgery in the buckling group than vitrectomy the group (2.4% versus 18.4%, p = 0.021).","['Patients', '85 patients were randomized, 80 eyes were included (41 receiving buckling, 39 received vitrectomy), and 78 patients completed the study', 'myopic traction maculopathy showing macular schisis (MS) and associated macular detachment (MD', 'macular schisis and associated macular detachment in high myopia']","['macular buckling and vitrectomy', 'Small gauge vitrectomy, internal limiting membrane peeling (ILMP) and C3F8 gas tamponade', 'Macular buckling and intravitreal C3F8 gas injection', 'buckling or vitrectomy']","['Best-corrected visual acuity ', 'efficacy and safety', 'recurrent conjunctival erosion', 'cataracts', 'surgical failure and required a second surgery', 'FTMH development', 'Macular buckling-associated strabismus (esotropia), binocular diplopia and implant exposure', 'BCVA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0231748', 'cui_str': 'Giving-way (finding)'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4552411', 'cui_str': 'Myopic traction maculopathy'}, {'cui': 'C3888987', 'cui_str': 'Macular detachment'}, {'cui': 'C0271183', 'cui_str': 'Severe myopia (disorder)'}]","[{'cui': 'C0231748', 'cui_str': 'Giving-way (finding)'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0456564', 'cui_str': 'Gauges (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0937858', 'cui_str': 'Perflutren'}, {'cui': 'C0579016', 'cui_str': 'Tamponade - action (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0859994', 'cui_str': 'Conjunctival erosion'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C1868733', 'cui_str': 'Surgical failure'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0231748', 'cui_str': 'Giving-way (finding)'}, {'cui': 'C0038379', 'cui_str': 'Phorias'}, {'cui': 'C0422985', 'cui_str': 'Double vision with both eyes open (disorder)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",85.0,0.0555161,"There were less eyes determined as surgical failure and required a second surgery in the buckling group than vitrectomy the group (2.4% versus 18.4%, p = 0.021).","[{'ForeName': 'Bingqian', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Shida', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Yonghao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lian', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Xiujuan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Xiling', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Chenjin', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Suber S', 'Initials': 'SS', 'LastName': 'Huang', 'Affiliation': 'Retina Center of Ohio, South Euclid, Ohio, USA.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}]",Acta ophthalmologica,['10.1111/aos.14260']
1122,31056441,"CFTR activity is enhanced by the novel corrector GLPG2222, given with and without ivacaftor in two randomized trials.","BACKGROUND


Several treatment approaches in cystic fibrosis (CF) aim to correct CF transmembrane conductance regulator (CFTR) function; the efficacy of each approach is dependent on the mutation(s) present. A need remains for more effective treatments to correct functional deficits caused by the F508del mutation.
METHODS


Two placebo-controlled, phase 2a studies evaluated GLPG2222, given orally once daily for 29 days, in subjects homozygous for F508del (FLAMINGO) or heterozygous for F508del and a gating mutation, receiving ivacaftor (ALBATROSS). The primary objective of both studies was to assess safety and tolerability. Secondary objectives included assessment of pharmacokinetics, and of the effect of GLPG2222 on sweat chloride concentrations, pulmonary function and respiratory symptoms.
RESULTS


Fifty-nine and 37 subjects were enrolled into FLAMINGO and ALBATROSS, respectively. Treatment-related treatment-emergent adverse events (TEAEs) were reported by 29.2% (14/48) of subjects in FLAMINGO and 40.0% (12/30) in ALBATROSS; most were mild to moderate in severity and comprised primarily respiratory, gastrointestinal, and infection events. There were no deaths or discontinuations due to TEAEs. Dose-dependent decreases in sweat chloride concentrations were seen in GLPG2222-treated subjects (maximum decrease in FLAMINGO: -17.6 mmol/L [GLPG2222 200 mg], p < 0.0001; ALBATROSS: -7.4 mmol/L [GLPG2222 300 mg], p < 0.05). No significant effects on pulmonary function or respiratory symptoms were reported. Plasma GLPG2222 concentrations in CF subjects were consistent with previous studies in healthy volunteers and CF subjects.
CONCLUSIONS


GLPG2222 was well tolerated. Sweat chloride reductions support on-target enhancement of CFTR activity in subjects with F508del mutation(s). Significant improvements in clinical endpoints were not demonstrated. Observed safety results support further evaluation of GLPG2222, including in combination with other CFTR modulators.
FUNDING


Galapagos NV. Clinical trial registration numbers FLAMINGO, NCT03119649; ALBATROSS, NCT03045523.",2019,"Treatment-related treatment-emergent adverse events (TEAEs) were reported by 29.2% (14/48) of subjects in FLAMINGO and 40.0% (12/30) in ALBATROSS; most were mild to moderate in severity and comprised primarily respiratory, gastrointestinal, and infection events.","['subjects homozygous for F508del (FLAMINGO) or heterozygous for F508del and a gating mutation, receiving ivacaftor (ALBATROSS', 'healthy volunteers and CF subjects', 'Fifty-nine and 37 subjects', 'subjects with F508del mutation(s', 'CF subjects', 'cystic fibrosis (CF']",['GLPG2222'],"['sweat chloride concentrations', 'safety and tolerability', 'tolerated', 'CFTR activity', 'Plasma GLPG2222 concentrations', 'sweat chloride concentrations, pulmonary function and respiratory symptoms', 'pulmonary function or respiratory symptoms']","[{'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C1006611', 'cui_str': 'Albatrosses'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}]",[],"[{'cui': 'C0428295', 'cui_str': 'Cystic fibrosis sweat test (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}]",,0.067018,"Treatment-related treatment-emergent adverse events (TEAEs) were reported by 29.2% (14/48) of subjects in FLAMINGO and 40.0% (12/30) in ALBATROSS; most were mild to moderate in severity and comprised primarily respiratory, gastrointestinal, and infection events.","[{'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Bell', 'Affiliation': 'Department of Thoracic Medicine, The Prince Charles Hospital and QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia. Electronic address: scott.bell@health.qld.gov.au.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Barry', 'Affiliation': 'Manchester Adult Cystic Fibrosis Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'De Boeck', 'Affiliation': 'University Hospital Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Drevinek', 'Affiliation': 'Department of Medical Microbiology, Charles University, Motol University Hospital, Prague, Czech Republic.'}, {'ForeName': 'J Stuart', 'Initials': 'JS', 'LastName': 'Elborn', 'Affiliation': ""Queen's University, Belfast, UK.""}, {'ForeName': 'Barry J', 'Initials': 'BJ', 'LastName': 'Plant', 'Affiliation': 'University College Cork, Cork, Ireland.'}, {'ForeName': 'Predag', 'Initials': 'P', 'LastName': 'Minić', 'Affiliation': 'Mother and Child Health Institute of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Van Braeckel', 'Affiliation': 'Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Verhulst', 'Affiliation': 'Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Muller', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Desirée', 'Initials': 'D', 'LastName': 'Kanters', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Bellaire', 'Affiliation': 'Galapagos UBV, Leiden, the Netherlands.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'de Kock', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Geller', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Conrath', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Van de Steen', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Kors', 'Initials': 'K', 'LastName': 'van der Ent', 'Affiliation': 'UMC Utrecht, Utrecht, the Netherlands.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2019.04.014']
1123,31362189,Cardiac output during targeted temperature management and renal function after out-of-hospital cardiac arrest.,"PURPOSE


After resuscitation from out-of-hospital cardiac arrest (OHCA), renal injury and hemodynamic instability are common. We aimed to assess the association between low cardiac output during targeted temperature management (TTM) and acute kidney injury (AKI) after OHCA.
MATERIALS AND METHODS


Single-center substudy of 171 patients included in the prospective, randomized TTM-trial. Hemodynamic evaluation was performed with serial measurements by pulmonary artery catheter. AKI was the primary endpoint and was defined according to the KDIGO-criteria.
RESULTS


Of 152 patients with available hemodynamic data, 49 (32%) had AKI and 21 (14%) had AKI with need for renal replacement therapy (RRT) in the first three days. During targeted temperature management, patients with AKI had higher heart rate (11 beats/min, p group  < 0.0001), higher mean arterial pressure (MAP) (4 mmHg, p group  = 0.001) and higher lactate (1 mmol/L, p group  < 0.0001) compared to patients without AKI. However, there was no difference in cardiac index (p group  = 0.25). In a multivariate logistic regression model, adjusting for potential confounders, MAP (p = .03), heart rate (p = .01) and lactate (p = .006), but not cardiac output, were independently associated with AKI.
CONCLUSIONS


Blood pressure, heart rate and lactate, but not cardiac output, during 24 h of TTM were associated with AKI in comatose OHCA-patients.",2019,"During targeted temperature management, patients with AKI had higher heart rate (11 beats/min, p group  < 0.0001), higher mean arterial pressure (MAP) (4 mmHg, p group  = 0.001) and higher lactate (1 mmol/L, p group  < 0.0001) compared to patients without AKI.","['152 patients with available hemodynamic data, 49 (32%) had AKI and 21 (14%) had AKI with need for renal replacement therapy (RRT) in the first three days', 'Single-center substudy of 171 patients included in the prospective, randomized TTM-trial']",[],"['cardiac index', 'Blood pressure, heart rate and lactate', 'heart rate', 'higher lactate', 'mean arterial pressure (MAP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",[],"[{'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}]",171.0,0.0898083,"During targeted temperature management, patients with AKI had higher heart rate (11 beats/min, p group  < 0.0001), higher mean arterial pressure (MAP) (4 mmHg, p group  = 0.001) and higher lactate (1 mmol/L, p group  < 0.0001) compared to patients without AKI.","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Grand', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Denmark. Electronic address: johannes.grand@regionh.dk.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bro-Jeppesen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hassager', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Rundgren', 'Affiliation': 'Department of Clinical Sciences, Lund University, Intensive and Perioperative Care, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Winther-Jensen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Jakob Hartvig', 'Initials': 'JH', 'LastName': 'Thomsen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Nielsen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wanscher', 'Affiliation': 'Department of Cardiothoracic Anaesthesia 4142, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Kjærgaard', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Denmark.'}]",Journal of critical care,['10.1016/j.jcrc.2019.07.013']
1124,31389835,"Comparing the McGrath Mac Video Laryngoscope and Direct Laryngoscopy for Prehospital Emergency Intubation in Air Rescue Patients: A Multicenter, Randomized, Controlled Trial.","OBJECTIVES


Tracheal intubation in prehospital emergency care is challenging. The McGrath Mac Video Laryngoscope (Medtronic, Minneapolis, MN) has been proven to be a reliable alternative for in-hospital airway management. This trial compared the McGrath Mac Video Laryngoscope and direct laryngoscopy for the prehospital setting.
DESIGN


Multicenter, prospective, randomized, controlled equivalence trial.
SETTING


Oesterreichischer Automobil- und Touring Club (OEAMTC) Helicopter Emergency Medical Service in Austria, 18-month study period.
PATIENTS


Five-hundred fourteen adult emergency patients (≥ 18 yr old).
INTERVENTIONS


Helicopter Emergency Medical Service physicians followed the institutional algorithm, comprising a maximum of two tracheal intubation attempts with each device, followed by supraglottic, then surgical airway access in case of tracheal intubation failure. No restrictions were given for tracheal intubation indication.
MEASUREMENTS MAIN RESULTS


The Primary outcome was the rate of successful tracheal intubation; equivalence range was ± 6.5% of success rates. Secondary outcomes were the number of attempts to successful tracheal intubation, time to glottis passage and first end-tidal CO2 measurement, degree of glottis visualization, and number of problems. The success rate for the two devices was equivalent: direct laryngoscopy 98.5% (254/258), McGrath Mac Video Laryngoscope 98.1% (251/256) (difference, 0.4%; 99% CI, -2.58 to 3.39). There was no statistically significant difference with regard to tracheal intubation times, number of attempts or difficulty. The view to the glottis was significantly better, but the number of technical problems was increased with the McGrath Mac Video Laryngoscope. After a failed first tracheal intubation attempt, immediate switching of the device was significantly more successful than after the second attempt (90.5% vs 57.1%; p = 0.0003), regardless of the method.
CONCLUSIONS


Both devices are equivalently well suited for use in prehospital emergency tracheal intubation of adult patients. Switching the device following a failed first tracheal intubation attempt was more successful than a second attempt with the same device.",2019,"The success rate for the two devices was equivalent: direct laryngoscopy 98.5% (254/258), McGrath Mac Video Laryngoscope 98.1% (251/256) (difference, 0.4%; 99% CI, -2.58 to 3.39).","['prehospital emergency tracheal intubation of adult patients', 'Oesterreichischer Automobil- und Touring Club (OEAMTC', 'Five-hundred fourteen adult emergency patients (≥ 18 yr old', 'Prehospital Emergency Intubation in Air Rescue Patients']","['McGrath Mac Video Laryngoscope and Direct Laryngoscopy', 'McGrath Mac Video Laryngoscope and direct laryngoscopy']","['tracheal intubation times, number of attempts or difficulty', 'success rate', 'number of attempts to successful tracheal intubation, time to glottis passage and first end-tidal CO2 measurement, degree of glottis visualization, and number of problems', 'number of technical problems', 'rate of successful tracheal intubation; equivalence range']","[{'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C0009545', 'cui_str': 'C5b-9'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}, {'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy (procedure)'}]","[{'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure (body structure)'}, {'cui': 'C3267130', 'cui_str': 'End-tidal CO2'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]",514.0,0.185522,"The success rate for the two devices was equivalent: direct laryngoscopy 98.5% (254/258), McGrath Mac Video Laryngoscope 98.1% (251/256) (difference, 0.4%; 99% CI, -2.58 to 3.39).","[{'ForeName': 'Janett', 'Initials': 'J', 'LastName': 'Kreutziger', 'Affiliation': 'Department of General and Surgical Critical Care Medicine, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Hornung', 'Affiliation': 'Department of Anesthesiology, Emergency and Critical Care Medicine, Wiener Neustadt General Hospital, Wiener Neustadt, Austria.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Harrer', 'Affiliation': 'OEAMTC Air Rescue, Vienna, Austria.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Urschl', 'Affiliation': 'OEAMTC Air Rescue, Vienna, Austria.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Doppler', 'Affiliation': 'OEAMTC Air Rescue, Vienna, Austria.'}, {'ForeName': 'Wolfgang G', 'Initials': 'WG', 'LastName': 'Voelckel', 'Affiliation': 'OEAMTC Air Rescue, Vienna, Austria.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Trimmel', 'Affiliation': 'Department of Anesthesiology, Emergency and Critical Care Medicine, Wiener Neustadt General Hospital, Wiener Neustadt, Austria.'}]",Critical care medicine,['10.1097/CCM.0000000000003918']
1125,31707181,Modified gemcitabine and oxaliplatin or gemcitabine + cisplatin in unresectable gallbladder cancer: Results of a phase III randomised controlled trial.,"AIM


To determine equivalence of modified gemcitabine and oxaliplatin compared with gemcitabine and cisplatin in unresectable gallbladder cancer (GBC). Primary end-point was overall survival (OS).
METHODS


Open label, prospective, randomised phase III equivalence study. Inclusion criteria included histologically proven unresectable GBC, 18 years or older, adequate organ functions and Eastern Cooperative Oncology Group ≤2.
SAMPLE SIZE


108 patients were required in each arm to have an equivalence margin of ±2 months with power of 80%.
TREATMENT


Modified gemcitabine and oxaliplatin (mGemOx)-gemcitabine 900 mg/m2, oxaliplatin 80 mg/m2, maximum 6 cycles; gemcitabine + cisplatin (CisGem)-gemcitabine 1000 mg/m2, cisplatin 25 mg/m2, maximum 8 cycles, all day 1 and 8 every 3 weeks.
RESULTS


Two hundred sixty subjects were recruited between February 2011 and July 2015. Two hundred forty-three patients (119, mGemOx and 124, CisGem) received at least 1 dose and analysed for safety and efficacy (modified intention to treat). Median OS was 8·5 months for whole group (95% confidence interval [CI]: 7·9-9·1). Median OS in mGemOx was 9 months and 8·3 months in CisGem; p = 0·057 (hazard ratio = 0·78; 95% CI = 0·60-1·02). Restricted mean OS for follow-up limited to 30 months was 11·2 months (95% CI: 9·8-12·6) in mGemOx and 10·4 months (95% CI: 9·1-11·7) in CisGem. Difference of the mean was 0·8 months with 95% CI, exceeding 2 months (-1·1 to 2·7), hence rejecting equivalence. Peripheral neuropathy, thrombocytopaenia in mGemOx and nephrotoxicity was higher with CisGem.
CONCLUSION


This trial failed to show equivalence of eight cycles of CisGem to six cycles of mGemOx. Numerically OS was better with mGemOx. Toxicities were different. The trial was not powered to answer superiority.
CLINICAL TRIAL REGISTRATION


CTRI/2010/091/001406.",2019,Median OS in mGemOx was 9 months and 8·3 months in CisGem; p = 0·057,"['Two hundred sixty subjects were recruited between February 2011 and July 2015', 'unresectable gallbladder cancer', 'Inclusion criteria included histologically proven unresectable GBC, 18 years or older, adequate organ functions and Eastern Cooperative Oncology Group ≤2', 'unresectable gallbladder cancer (GBC', 'Two hundred forty-three patients (119, mGemOx and 124, CisGem']","['gemcitabine and oxaliplatin', 'gemcitabine and cisplatin', 'gemcitabine + cisplatin (CisGem)-gemcitabine 1000 mg/m2, cisplatin', 'mGemOx)-gemcitabine 900 mg/m2, oxaliplatin', 'modified gemcitabine and oxaliplatin', 'Modified gemcitabine and oxaliplatin or gemcitabine + cisplatin']","['Peripheral neuropathy, thrombocytopaenia in mGemOx and nephrotoxicity', 'Median OS in mGemOx', 'Toxicities', 'overall survival (OS', 'Median OS']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0153452', 'cui_str': 'Cancer of Gallbladder'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C4057589', 'cui_str': 'gemcitabine 1000 MG'}, {'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0599918', 'cui_str': 'Nephrotoxicity'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",260.0,0.107962,Median OS in mGemOx was 9 months and 8·3 months in CisGem; p = 0·057,"[{'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Department of Medical Oncology, Dr BRA IRCH, AIIMS, New Delhi 110029, India. Electronic address: Atul1@hotmail.com.'}, {'ForeName': 'Bidhu', 'Initials': 'B', 'LastName': 'Kalyan Mohanti', 'Affiliation': 'Department of Radiation Oncology, Dr BRA IRCH, AIIMS, New Delhi 110029, India. Electronic address: drbkmohanti@gmail.com.'}, {'ForeName': 'Surendra', 'Initials': 'S', 'LastName': 'Pal Chaudhary', 'Affiliation': 'Department of Medical Oncology, Dr BRA IRCH, AIIMS, New Delhi 110029, India. Electronic address: Drsurendra101@gmail.com.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Sreenivas', 'Affiliation': 'Department of Biostatistics, AIIMS, New Delhi 110029, India. Electronic address: sreevishnubhatla@gmail.com.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Kumar Sahoo', 'Affiliation': 'Department of Medical Oncology, Dr BRA IRCH, AIIMS, New Delhi 110029, India. Electronic address: drranjitmd@gmail.com.'}, {'ForeName': 'Nootan', 'Initials': 'N', 'LastName': 'Kumar Shukla', 'Affiliation': 'Department of Surgical Oncology, Dr BRA IRCH, AIIMS, New Delhi 110029, India. Electronic address: Nkshukla2@yahoo.com.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Thulkar', 'Affiliation': 'Department of Radio Diagnosis, Dr BRA IRCH, AIIMS, New Delhi 110029, India. Electronic address: sanjaythulkar@gmail.com.'}, {'ForeName': 'Sujoy', 'Initials': 'S', 'LastName': 'Pal', 'Affiliation': 'Department of Gastrointestinal Surgery and Liver Transplantation, AIIMS, New Delhi 110029, India. Electronic address: sujoypal@hotmail.com.'}, {'ForeName': 'Surya V', 'Initials': 'SV', 'LastName': 'Deo', 'Affiliation': 'Department of Surgical Oncology, Dr BRA IRCH, AIIMS, New Delhi 110029, India. Electronic address: svsdeo@yahoo.co.in.'}, {'ForeName': 'Sushmita', 'Initials': 'S', 'LastName': 'Pathy', 'Affiliation': 'Department of Radiation Oncology, Dr BRA IRCH, AIIMS, New Delhi 110029, India. Electronic address: drspathy@gmail.com.'}, {'ForeName': 'Nihar', 'Initials': 'N', 'LastName': 'Ranjan Dash', 'Affiliation': 'Department of Gastrointestinal Surgery and Liver Transplantation, AIIMS, New Delhi 110029, India. Electronic address: nagranjan@gmail.com.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Department of Surgical Oncology, Dr BRA IRCH, AIIMS, New Delhi 110029, India. Electronic address: Dr_sunilk@hotmail.com.'}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Bhatnagar', 'Affiliation': 'Department of Onco-anaesthesia and Palliative Medicine, Dr BRA IRCH, AIIMS, New Delhi, 110029, India. Electronic address: sushmabhatnagar1@gmail.com.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Professor Department of Nuclear Medicine, AIIMS, New Delhi, 110029, India. Electronic address: rkphulia@yahoo.com.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Mishra', 'Affiliation': 'Professor Department of Nuclear Medicine, AIIMS, New Delhi, 110029, India. Electronic address: seemamishra2003@gmail.com.'}, {'ForeName': 'Peush', 'Initials': 'P', 'LastName': 'Sahni', 'Affiliation': 'Department of Gastrointestinal Surgery and Liver Transplantation, AIIMS, New Delhi 110029, India. Electronic address: peush_sahni@hotmail.com.'}, {'ForeName': 'Venkateswaran K', 'Initials': 'VK', 'LastName': 'Iyer', 'Affiliation': 'Department of Pathology, AIIMS, New Delhi 110029, India. Electronic address: iyervenkat4@gmail.com.'}, {'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Raina', 'Affiliation': 'Department of Medical Oncology, Dr BRA IRCH, AIIMS, New Delhi 110029, India. Electronic address: vinodraina@hotmail.com.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.10.004']
1126,31053619,Heat-moulded versus custom-made mandibular advancement devices for obstructive sleep apnoea: a randomised non-inferiority trial.,"RATIONALE


Custom-made mandibular advancement devices (MADs) are reported as providing higher efficacy rates compared with thermoplastic heat-moulded MADs but at the price of higher costs and treatment delays.
OBJECTIVE


To determine whether a thermoplastic heat-moulded titratable MAD (ONIRIS; ONIRIS SAS, Rueil Malmaison, France) is non-inferior to a custom-made acrylic titratable MAD (TALI; ONIRIS SAS, Rueil Malmaison, France) for obstructive sleep apnoea (OSA).
METHODS


We conducted a multicentre, open, randomised controlled trial of patients with OSA refusing or not tolerating continuous positive airway pressure (CPAP). Participants were randomly assigned to a thermoplastic heat-moulded titratable device or a custom-made acrylic device for 2 months with stratification by centre and OSA severity. The non-inferiority primary outcome was a ≥50% reduction in apnoea-hypopnoea index (AHI) or achieving AHI <10 events/hour at 2 months. The non-inferiority margin was preset as a difference between groups of 20% for the primary outcome in the per-protocol analysis.
MAIN RESULTS


Of 198 patients (mean age 51 [SD, 12] years; 138 [72.6%] men; mean body mass index 26 [SD, 2.7] kg/m 2 ; mean AHI 26.6/hour [SD, 10.4]), 100 received TALI and 98 ONIRIS. In per-protocol analysis, the response rate was 51.7% in the TALI group versus 53.6% in the ONIRIS group (absolute difference 1.9%; 90% CI: 11% to 15%, within the non-inferiority margin). Effectiveness was the same for severity, symptoms, quality of life and blood pressure reduction. Patients in ONIRIS group reported more side effects and adherence was slightly better with TALI.
CONCLUSION


In patients with OSA refusing or not tolerating CPAP, the thermoplastic heat-moulded titratable MAD was non-inferior in the short-term to the custom-made acrylic MAD.
TRIAL REGISTRATION NUMBER


NCT02348970.",2019,The non-inferiority primary outcome was a ≥50% reduction in apnoea-hypopnoea index (AHI) or achieving AHI <10 events/hour at 2 months.,"['Of 198 patients (mean age 51 [SD, 12] years; 138 [72.6%] men; mean body mass index 26 [SD, 2.7] kg/m 2 ; mean AHI 26.6/hour [SD, 10.4]), 100 received TALI and 98 ONIRIS', 'obstructive sleep apnoea', 'patients with OSA refusing or not tolerating continuous positive airway pressure (CPAP', 'patients with OSA refusing or not tolerating CPAP']","['thermoplastic heat-moulded titratable MAD (ONIRIS', 'Heat-moulded versus custom-made mandibular advancement devices', 'thermoplastic heat-moulded titratable device or a custom-made acrylic device', 'TALI']","['side effects and adherence', 'response rate', 'apnoea-hypopnoea index (AHI) or achieving AHI', 'ONIRIS SAS, Rueil Malmaison, France) for obstructive sleep apnoea (OSA', 'severity, symptoms, quality of life and blood pressure reduction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0039277', 'cui_str': 'Astragalus Bone'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0369241', 'cui_str': 'Molds'}, {'cui': 'C0671759', 'cui_str': 'MAD'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0376461', 'cui_str': 'Mandibular Advancement'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material (substance)'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",198.0,0.322971,The non-inferiority primary outcome was a ≥50% reduction in apnoea-hypopnoea index (AHI) or achieving AHI <10 events/hour at 2 months.,"[{'ForeName': 'Jean Louis', 'Initials': 'JL', 'LastName': 'Pépin', 'Affiliation': ""HP2 (Hypoxia Pathopysiologies) Laboratory, Universite Grenoble Alpes, Saint-Martin-d'Heres 38400, France jpepin@chu-grenoble.fr.""}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Raymond', 'Affiliation': 'Sleep Apnoea Centre, New Bel-Air Clinic, Bordeaux, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Lacaze', 'Affiliation': 'Perpignan Sleep Medicine Practice, Perpignan, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Aisenberg', 'Affiliation': 'Les Pavillons sous Bois ENT Practice, Les Pavillons sous Bois, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Forcioli', 'Affiliation': 'Ear, Nose and Throat Department, New Bel-Air Clinic, Bordeaux, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bonte', 'Affiliation': 'Odontology Department, Hôpital Bretonneau, AP-HP, Paris, French Polynesia.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Bourdin', 'Affiliation': 'Department of Pneumology, CHRU Montpellier, Montpellier, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Launois', 'Affiliation': 'HP2 (Hypoxia Pathopysiologies) Laboratory, INSERM U1042 Unit, University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Tamisier', 'Affiliation': 'HP2 (Hypoxia Pathopysiologies) Laboratory, INSERM U1042 Unit, University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Molinari', 'Affiliation': 'Medical Information, CHRU Montpellier, UMR 729 MISTEA, University of Montpellier I, Montpellier, France.'}]",Thorax,['10.1136/thoraxjnl-2018-212726']
1127,31047956,Association of Angiotensin Modulators With the Course of Idiopathic Pulmonary Fibrosis.,"BACKGROUND


Angiotensin peptides have been implicated in idiopathic pulmonary fibrosis (IPF) pathogenesis. Angiotensin modulators are used to treat arterial hypertension, a frequent comorbidity of IPF. This post hoc analysis evaluated associations of antihypertensive treatments with disease-related outcomes in IPF.
METHODS


All patients randomized to placebo (n = 624) in the CAPACITY and ASCEND studies were categorized by antihypertensive treatment at baseline. Outcomes of disease progression (first occurrence of ≥ 10% absolute decline in % predicted FVC, ≥ 50-m decline in 6-min walk distance, or death) and all-cause mortality were assessed over 52 weeks.
RESULTS


At baseline, 111 and 121 patients were receiving an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB), respectively; 392 were receiving neither. In multivariable analyses adjusted for differences in baseline characteristics compared with the non-ACEi/ARB group, ACEi treatment (hazard ratio [HR], 0.6 [95% CI, 0.4-0.9]; P = .026), but not ARB (HR, 0.9 [95% CI, 0.6-1.2]; P = .413), was associated with slower disease progression. Furthermore, the increase in all-cause mortality associated with cardiovascular disease was not observed in the ACEi group (HR, 1.1 [95% CI, 0.5-2.9]; P = .782), which presented a similar percentage of IPF-related mortality as the non-ACEi/ARB group (3.6% vs 3.6%). In contrast, patients in the ARB group had greater risk of all-cause mortality (HR, 2.5 [95% CI, 1.2-5.2]). These observations were validated in a pooled analysis that included patients from the INSPIRE trial.
CONCLUSIONS


Prospective clinical trials are needed to evaluate whether angiotensin modulators may be beneficial to clinical outcomes in IPF.
TRIAL REGISTRY


ClinicalTrials.gov; Nos.: NCT01366209, NCT00287716, NCT00287729, NCT00075998; URL: www.clinicaltrials.gov).",2019,"In contrast, patients in the ARB group had greater risk of all-cause mortality (HR, 2.5 [95% CI, 1.2-5.2]).","['ARB), respectively; 392 were receiving neither', '121 patients were receiving an']","['angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker', 'placebo']","['cardiovascular disease', '50-m decline in 6-min walk distance, or death) and all-cause mortality', 'disease progression', 'greater risk of all-cause mortality']","[{'cui': 'C1264693', 'cui_str': 'Arbitrary'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II Receptor Blockers'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.213252,"In contrast, patients in the ARB group had greater risk of all-cause mortality (HR, 2.5 [95% CI, 1.2-5.2]).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kreuter', 'Affiliation': 'Center for Interstitial and Rare Lung Disease, Thoraxklinik, University of Heidelberg, Heidelberg, Germany. Electronic address: michael.kreuter@med.uni-heidelberg.de.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Lederer', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Molina-Molina', 'Affiliation': ""University Hospital of Bellvitge, Institut d'Investigació Biomédica de Bellvitge, Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Noth', 'Affiliation': 'Division of Pulmonary and Critical Care, Department of Medicine, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Valenzuela', 'Affiliation': 'Pulmonology Department, Hospital Universitario de la Princesa, Madrid, Spain.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Frankenstein', 'Affiliation': 'Department of Cardiology, Angiology, and Pulmonology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Weycker', 'Affiliation': 'Policy Analysis Inc. (PAI), Brookline, MA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Atwood', 'Affiliation': 'Policy Analysis Inc. (PAI), Brookline, MA.'}, {'ForeName': 'Klaus-Uwe', 'Initials': 'KU', 'LastName': 'Kirchgaessler', 'Affiliation': 'F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Cottin', 'Affiliation': 'Department of Respiratory Medicine, Reference Center for Rare Pulmonary Diseases, Louis Pradel Hospital, Claude Bernard University Lyon 1, UMR754, Lyon, France.'}]",Chest,['10.1016/j.chest.2019.04.015']
1128,32410683,Effect of ulinastatin on post-operative blood loss and allogeneic transfusion in patients receiving cardiac surgery with cardiopulmonary bypass: a prospective randomized controlled study with 10-year follow-up.,"BACKGROUND


Major bleeding and allogeneic transfusion leads to negative outcomes in patients receiving cardiac surgery with cardiopulmonary bypass (CPB). Ulinastatin, a urine trypsin inhibitor, relieves systemic inflammation and improves coagulation profiles with however sparse evidence of its effects on blood loss and allogeneic transfusion in this specific population.
METHODS


In this prospective randomized controlled trial, 426 consecutive patients receiving open heart surgery with CPB were randomly assigned into three groups to receive ulinastatin (group U, n = 142), tranexamic acid (group T, n = 143) or normal saline (group C, n = 141). The primary outcome was the total volume of post-operative bleeding and the secondary outcome included the volume and exposure of allogeneic transfusion, the incidence of stroke, post-operative myocardial infarction, renal failure, respiratory failure and all-cause mortality. A ten-year follow-up was carried on to evaluate long-term safety.
RESULTS


Compared with placebo, ulinastatin significantly reduced the volume of post-operative blood loss within 24 h (688.39 ± 393.55 ml vs 854.33 ± 434.03 ml MD - 165.95 ml, 95%CI - 262.88 ml to - 69.01 ml, p < 0.001) and the volume of allogeneic erythrocyte transfusion (2.57 ± 3.15 unit vs 3.73 ± 4.21 unit, MD-1.16 unit, 95%CI - 2.06 units to - 0.26 units, p = 0.002). The bleeding and transfusion outcomes were comparable between the ulinastatin group and the tranexamic acid group. In-hospital outcomes and 10-year follow-up showed no statistical difference in mortality and major morbidity among groups.
CONCLUSIONS


Ulinastatin reduced post-operative blood loss and allogeneic erythrocyte transfusion in heart surgery with CPB. The mortality and major morbidity was comparable among the groups shown by the 10-year follow-up.
TRIAL REGISTRATION


The trial was retrospectively registered on February 2, 2010.
TRIAL REGISTRATION NUMBER


https://www.clinicaltrials.gov Identifier: NCT01060189.",2020,"In-hospital outcomes and 10-year follow-up showed no statistical difference in mortality and major morbidity among groups.
","['patients receiving cardiac surgery with cardiopulmonary bypass (CPB', 'heart surgery with CPB', '426 consecutive patients receiving open heart surgery with CPB', 'patients receiving cardiac surgery with cardiopulmonary bypass']","['Ulinastatin', 'normal saline', 'placebo, ulinastatin', 'tranexamic acid', 'ulinastatin']","['blood loss and allogeneic transfusion', 'volume of post-operative blood loss', 'bleeding and transfusion outcomes', 'mortality and major morbidity', 'total volume of post-operative bleeding and the secondary outcome included the volume and exposure of allogeneic transfusion, the incidence of stroke, post-operative myocardial infarction, renal failure, respiratory failure and all-cause mortality', 'volume of allogeneic erythrocyte transfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery'}]","[{'cui': 'C0077906', 'cui_str': 'urinastatin'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}]",426.0,0.171357,"In-hospital outcomes and 10-year follow-up showed no statistical difference in mortality and major morbidity among groups.
","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 Beilishi Rd., Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Lv', 'Affiliation': 'Department of Anaesthesiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 Beilishi Rd., Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': ""Department of Anaesthesiology, People's Hospital of Ningxia Hui Autonomous Region, 148 Huaiyuanxi Rd. Xixia District, Ningxia Hui Autonomous Region, Yinchuan, 750021, China.""}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': 'Department of Anaesthesiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 Beilishi Rd., Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Xue', 'Affiliation': 'Department of Anaesthesiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 Beilishi Rd., Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Anaesthesiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 Beilishi Rd., Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Lihuan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Anaesthesiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 Beilishi Rd., Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Anaesthesiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 Beilishi Rd., Xicheng District, Beijing, 100037, China. shijia@fuwai.com.'}]",Journal of cardiothoracic surgery,['10.1186/s13019-020-01144-9']
1129,32410684,A sex education program for teachers of preschool children: a quasi-experimental study in Iran.,"BACKGROUND


Sex education is an important educational dimension. Together with families, teachers play a significant role in providing sex education to children. However, in most cases, they do not have enough information on this topic. The present study aimed to determine the effects of a preschool sex education program on preschool teachers' knowledge and attitude.
METHODS


In this quasi-experimental study, 80 teachers working at preschools in Tehran, Iran, were randomly allocated to experimental and control groups. The educational program was provided in two 90-min sessions for the experimental group while the control group received no intervention. A self-designed knowledge and attitude questionnaire was completed by both groups before and 1 month after the intervention. This questionnaire evaluated knowledge and attitude in six domains of principles of sex education, sexual identity, stages of development and proper methods of sex education, sex-related questions, masturbation, and sexual abuse. Data were analysed in SPSS 18 using descriptive statistics as well as independent samples t-test, paired-samples t-test, chi-squared test, and ANCOVA at p < 0.05.
RESULTS


Mean scores of knowledge and attitude in all dimensions showed a significant increase in the experimental group following the educational intervention. However, no difference was observed in the control group. Following the educational intervention, mean scores of teachers' knowledge and attitude in all six domains showed a significant difference with that of the control group (p < 0.001).
CONCLUSIONS


Results revealed that the sex education program can promote the knowledge and attitude of preschool teachers in all domains.
TRIAL REGISTRATION


Iranian Registry of Clinical Trials: IRCT2016122320854N5. Registered on 9 March 2017. ""Retrospectively registered"".",2020,"Following the educational intervention, mean scores of teachers' knowledge and attitude in all six domains showed a significant difference with that of the control group (p < 0.001).
","['80 teachers working at preschools in Tehran, Iran', 'teachers of preschool children']","['preschool sex education program', 'control group received no intervention']","[""preschool teachers' knowledge and attitude"", 'Mean scores of knowledge and attitude', ""mean scores of teachers' knowledge and attitude""]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}]","[{'cui': 'C0036879', 'cui_str': 'Sexuality education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",80.0,0.0143106,"Following the educational intervention, mean scores of teachers' knowledge and attitude in all six domains showed a significant difference with that of the control group (p < 0.001).
","[{'ForeName': 'Jeno', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Department of Midwifery and Reproductive Health, Student Research Committee, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hedyeh', 'Initials': 'H', 'LastName': 'Riazi', 'Affiliation': 'Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, ValiAsr Ave., Cross of Niayesh Highway and ValiAsr, Tehran, 1996835119, Iran. h.riazi@sbmu.ac.ir.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Firoozi', 'Affiliation': 'Department of Psychology, School of Psychology and Social Sciences, Islamic Azad University Roudehen branch, Tehran, Iran.'}, {'ForeName': 'Maliheh', 'Initials': 'M', 'LastName': 'Nasiri', 'Affiliation': 'Department of Biostatics, School of Paramedical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",BMC public health,['10.1186/s12889-020-08826-y']
1130,31729933,Psychological and endocannabinoid responses to aerobic exercise in substance use disorder patients.,"Background : Exercise has been examined as an adjunctive treatment for substance use disorders (SUDs), yet few exercise interventions have been conducted among patients undergoing intensive outpatient (IOP) treatment, who may be the most vulnerable to relapse and for whom exercise could provide the most benefits. This study examined the effects of aerobic exercise, in addition to IOP treatment, on psychological variables and endocannabinoids in individuals with SUDs.  Methods : Twenty-one SUD patients (mean age 35 years) were recruited from local IOPs. Participants were randomized to either treatment-as-usual (TAU, at their outpatient clinic) or TAU plus aerobic exercise training (EX). EX participants engaged in supervised, moderate-intensity exercise for 30 min, 3 times/week for 6 weeks. TAU participants came into the laboratory once per week for assessments and a 30-min quiet rest session. Participants provided blood samples and completed questionnaires evaluating substance use, mood states, depression, anxiety, perceived stress, self-efficacy to abstain from substance use, and craving. Data were analyzed with Mann-Whitney  U  tests or mixed model ANOVAs to determine group differences in outcomes acutely and over 6 weeks.  Results : Over 6 weeks, there were reductions in perceived stress ( p  < 0.01) and craving ( p  < 0.05) for both groups. There were no group differences in abstinence rates or changes from baseline in self-efficacy, depression, or anxiety ( p  > 0.05). Acutely, both exercise and quiet rest sessions led to reductions in craving, tension, depression, anger, confusion, and total mood disturbance (all  p s < 0.05). In addition, the EX group experienced acute increases in vigor and circulating concentrations of the endocannabinoid, anandamide ( p  < 0.01).  Conclusions : An adjunctive aerobic exercise program during SUD treatment was associated with similar reductions in perceived stress and drug craving as standard care. Thirty minutes of exercise or quiet rest led to acute improvements in mood, but exercise produced the additional benefit of increases in vigor and circulating anandamide.",2019,"There were no group differences in abstinence rates or changes from baseline in self-efficacy, depression, or anxiety ( p  > 0.05).","['patients undergoing intensive outpatient (IOP) treatment', 'Twenty-one SUD patients (mean age 35\u2009years', 'substance use disorder patients', 'individuals with SUDs']","['adjunctive aerobic exercise program', 'TAU plus aerobic exercise training (EX', 'exercise or quiet rest', 'exercise and quiet rest sessions', 'aerobic exercise']","['craving', 'blood samples and completed questionnaires evaluating substance use, mood states, depression, anxiety, perceived stress, self-efficacy to abstain from substance use, and craving', 'perceived stress and drug craving', 'self-efficacy, depression, or anxiety', 'abstinence rates', 'vigor and circulating anandamide', 'vigor and circulating concentrations', 'perceived stress', 'craving, tension, depression, anger, confusion, and total mood disturbance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439654', 'cui_str': 'Quiet (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0556446', 'cui_str': 'Craves for drugs (finding)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0211726', 'cui_str': 'anandamide (20.4,n-6)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0009676', 'cui_str': 'Confusional State'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",21.0,0.0933737,"There were no group differences in abstinence rates or changes from baseline in self-efficacy, depression, or anxiety ( p  > 0.05).","[{'ForeName': 'Angelique G', 'Initials': 'AG', 'LastName': 'Brellenthin', 'Affiliation': 'Department of Kinesiology, University of Wisconsin, Madison, Wisconsin, USA.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Crombie', 'Affiliation': 'Department of Kinesiology, University of Wisconsin, Madison, Wisconsin, USA.'}, {'ForeName': 'Cecilia J', 'Initials': 'CJ', 'LastName': 'Hillard', 'Affiliation': 'Department of Pharmacology and Toxicology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Randall T', 'Initials': 'RT', 'LastName': 'Brown', 'Affiliation': 'Department of Family Medicine, University of Wisconsin, Madison, Wisconsin, USA.'}, {'ForeName': 'Kelli F', 'Initials': 'KF', 'LastName': 'Koltyn', 'Affiliation': 'Department of Kinesiology, University of Wisconsin, Madison, Wisconsin, USA.'}]",Substance abuse,['10.1080/08897077.2019.1680480']
1131,32410694,"Long-term safety and tolerability of atabecestat (JNJ-54861911), an oral BACE1 inhibitor, in early Alzheimer's disease spectrum patients: a randomized, double-blind, placebo-controlled study and a two-period extension study.","BACKGROUND


Atabecestat, a potent brain-penetrable inhibitor of BACE1 activity that reduces CSF amyloid beta (Aβ), was developed for oral treatment for Alzheimer's disease (AD). The long-term safety and effect of atabecestat on cognitive performance in participants with predementia AD in two phase 2 studies were assessed.
METHODS


In the placebo-controlled double-blind parent ALZ2002 study, participants aged 50 to 85 years were randomized (1:1:1) to placebo or atabecestat 10 or 50 mg once daily (later reduced to 5 and 25 mg) for 6 months. Participants entered ALZ2004, a 12-month treatment extension with placebo or atabecestat 10 or 25 mg, followed by an open-label phase. Safety, changes in CSF biomarker levels, brain volume, and effects on cognitive performance were assessed.
RESULTS


Of 114 participants randomized in ALZ2002, 99 (87%) completed, 90 entered the ALZ2004 double-blind phase, and 77 progressed to the open-label phase. CSF Aβ fragments and sAPPβ were reduced dose-proportionately. Decreases in whole brain and hippocampal volumes were greater in participants with mild cognitive impairment (MCI) due to AD than in preclinical AD, but were not affected by treatment. In ALZ2004, change from baseline in RBANS trended toward worse scores for atabecestat versus placebo. Elevated liver enzyme adverse events reported in 12 participants on atabecestat resulted in dosage modification and increased frequency of safety monitoring. Treatment discontinuation normalized ALT or AST in all except one with pretreatment elevation, which remained mildly elevated. No case met ALT/AST > 3× ULN and total bilirubin > 2× ULN (Hy's law).
CONCLUSION


Atabecestat was associated with trend toward declines in cognition, and elevation of liver enzymes.
TRIAL REGISTRATION


ALZ2002: ClinicalTrials.gov, NCT02260674, registered October 9, 2014; ALZ2004: ClinicalTrials.gov, NCT02406027, registered April 1, 2015.",2020,Elevated liver enzyme adverse events reported in 12 participants on atabecestat resulted in dosage modification and increased frequency of safety monitoring.,"[""early Alzheimer's disease spectrum patients"", 'participants aged 50 to 85\u2009years', '114 participants randomized in ALZ2002, 99 (87%) completed', 'participants with predementia AD in two phase 2 studies were assessed', ""Alzheimer's disease (AD""]","['placebo or atabecestat 10 or 25\u2009mg, followed by an open-label phase', 'atabecestat', 'placebo or atabecestat', 'atabecestat (JNJ-54861911', 'placebo-controlled double-blind parent ALZ2002', 'placebo']","['cognitive performance', 'cognition, and elevation of liver enzymes', 'total bilirubin', 'Safety, changes in CSF biomarker levels, brain volume, and effects on cognitive performance', 'whole brain and hippocampal volumes', 'Elevated liver enzyme adverse events', 'frequency of safety monitoring']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0235996', 'cui_str': 'Hepatic enzyme increased'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]",114.0,0.639533,Elevated liver enzyme adverse events reported in 12 participants on atabecestat resulted in dosage modification and increased frequency of safety monitoring.,"[{'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Novak', 'Affiliation': 'Janssen Research and Development LLC, 1125 Trenton-Harbourton Rd, Titusville, NJ, 08560, USA. gnovak1@its.jnj.com.'}, {'ForeName': 'Johannes Rolf', 'Initials': 'JR', 'LastName': 'Streffer', 'Affiliation': 'Janssen Research and Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Timmers', 'Affiliation': 'Janssen Research and Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Henley', 'Affiliation': 'Janssen Research and Development LLC, 1125 Trenton-Harbourton Rd, Titusville, NJ, 08560, USA.'}, {'ForeName': 'H Robert', 'Initials': 'HR', 'LastName': 'Brashear', 'Affiliation': 'Janssen Research and Development LLC, 1125 Trenton-Harbourton Rd, Titusville, NJ, 08560, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Bogert', 'Affiliation': 'Janssen Research and Development LLC, Raritan, NJ, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Russu', 'Affiliation': 'Janssen Research and Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Janssens', 'Affiliation': 'Janssen Research and Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Tesseur', 'Affiliation': 'Janssen Research and Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Tritsmans', 'Affiliation': 'Janssen Research and Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Van Nueten', 'Affiliation': 'Janssen Research and Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Engelborghs', 'Affiliation': 'Reference Center for Biological Markers of Dementia (BIODEM), Institute Born-Bunge, University of Antwerp, Antwerp, Belgium.'}]",Alzheimer's research & therapy,['10.1186/s13195-020-00614-5']
1132,30681720,Pharmacological Management of Delirium in the Intensive Care Unit: A Randomized Pragmatic Clinical Trial.,"BACKGROUND/OBJECTIVE


Delirium in the intensive care units (ICUs) is prevalent, with both delirium duration and delirium severity associated with adverse outcomes. We designed a pragmatic trial to test the efficacy of a pharmacological management of delirium (PMD) bundle in improving delirium/coma-free days and reducing delirium severity among ICU patients.
DESIGN


A randomized pragmatic clinical trial.
SETTING


Medical, surgical, and progressive ICUs of three tertiary care hospitals.
PARTICIPANTS


A total of 351 critically ill patients.
INTERVENTION


A multicomponent PMD bundle consisting of reducing the exposure to 20 definite anticholinergic medications and benzodiazepines and prescribing low-dose haloperidol.
MEASUREMENTS


The primary outcomes were delirium/coma-free days, measured through the Richmond Agitation-Sedation Scale and the Confusion Assessment Method for the ICU (CAM-ICU), and delirium severity, measured through Delirium Rating Scale-Revised-98 and the CAM-ICU-7. Secondary outcomes were in-hospital and posthospital discharge 30-day mortality, ICU and hospital lengths of stay, and delirium-related hospital complications.
RESULTS


We randomized 351 critically ill delirious patients (mean age = 59.3 years [SD = 16.9 years]; 52% female, 42% African Americans) to receive the PMD bundle or usual care. There were no significant differences in median delirium/coma-free days at day 8 (PMD vs usual care = 4 [interquartile range {IQR} = 2-7] days vs 5 [IQR = 1-7] days; P = .888) or at day 30 (PMD vs usual care = 26 [IQR 19-29] days vs 26 [IQR, 14-29] days; P = .991). There were no significant differences for decrease in delirium severity at day 8, but at hospital discharge, the intervention group showed a greater reduction in delirium severity (mean decrease in CAM-ICU-7 score for PMD vs usual care = 3.2 [SD = 3.3] vs 2.5 [SD = 3.2]; P = .046). No differences were observed between groups for ICU and hospital lengths of stay, mortality, and delirium-related hospital complications. Similar results were observed when analyses were limited to patients 65 years or older and 75 years or older.
CONCLUSION AND RELEVANCE


Implementing the PMD bundle in the ICU did not reduce delirium duration or severity among critically ill patients.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT00842608. J Am Geriatr Soc 67:1057-1065, 2019.",2019,"There were no significant differences for decrease in delirium severity at day 8, but at hospital discharge, the intervention group showed a greater reduction in delirium severity (mean decrease in CAM-ICU-7 score for PMD vs usual care = 3.2 [SD = 3.3] vs 2.5 [SD = 3.2]; P = .046).","['Delirium in the Intensive Care Unit', 'Medical, surgical, and progressive ICUs of three tertiary care hospitals', 'patients 65 years or older and 75 years or older', 'ICU patients', '351 critically ill delirious patients (mean age = 59.3 years [SD = 16.9 years]; 52% female, 42% African Americans', 'critically ill patients', 'A total of 351 critically ill patients']","['benzodiazepines and prescribing low-dose haloperidol', 'PMD bundle or usual care']","['delirium severity', 'ICU and hospital lengths of stay, mortality, and delirium-related hospital complications', 'delirium duration or severity', 'delirium/coma-free days, measured through the Richmond Agitation-Sedation Scale and the Confusion Assessment Method for the ICU (CAM-ICU), and delirium severity, measured through Delirium Rating Scale-Revised-98 and the CAM-ICU-7', 'CAM-ICU-7 score', 'hospital and posthospital discharge 30-day mortality, ICU and hospital lengths of stay, and delirium-related hospital complications', 'median delirium/coma-free days']","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0009676', 'cui_str': 'Confusional State'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",351.0,0.199976,"There were no significant differences for decrease in delirium severity at day 8, but at hospital discharge, the intervention group showed a greater reduction in delirium severity (mean decrease in CAM-ICU-7 score for PMD vs usual care = 3.2 [SD = 3.3] vs 2.5 [SD = 3.2]; P = .046).","[{'ForeName': 'Babar A', 'Initials': 'BA', 'LastName': 'Khan', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Perkins', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Noll L', 'Initials': 'NL', 'LastName': 'Campbell', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Sujuan', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Mark O', 'Initials': 'MO', 'LastName': 'Farber', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Sikandar H', 'Initials': 'SH', 'LastName': 'Khan', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Ben L', 'Initials': 'BL', 'LastName': 'Zarzaur', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Malaz A', 'Initials': 'MA', 'LastName': 'Boustani', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.15781']
1133,31727915,Safety profile of sedative endoscopy including cognitive performance in liver cirrhosis: A double-blind randomized controlled trial.,"The indiscriminate use of sedative drugs during endoscopy can pose multiple risks including cognitive impairment in advanced liver cirrhosis. However, the data are scarce regarding which sedative drugs are safest in these populations. The aim of this study was to evaluate the safety profiles including cognitive performance among midazolam, propofol, and combination therapy in advanced cirrhotic patients. This double-blind randomized controlled study included 60 consecutive advanced cirrhotic patients who underwent upper gastrointestinal endoscopy. The Stroop application was used to screen for cognitive impairment. Patients were randomly assigned to one of 3 groups, midazolam, propofol, or the combination group, and underwent Stroop test before and two hours after the completion of endoscopy. Hemodynamic safety and the subjective satisfaction score were also evaluated. Patients did not show significant changes in on-time or off-time on the Stroop test before and two hours after sedatives, and there was no significant difference among the 3 treatment groups. Also, there were no significant vital sign changes after sedatives. Time-to-recovery was longest in midazolam group, and patient awakening and patient memory were highest in propofol group. However, all 3 groups showed no difference in patient satisfaction, but the combination group was more preferred in terms of subjective satisfaction by physicians. Factors affecting worsened Stroop speed after sedatives were older age, low education level and high MELD score. All sedative methods using midazolam, propofol, or combination therapy showed similar safety profile in advanced cirrhosis, and were not associated with increased risk of cognitive impairment.",2019,"Patients did not show significant changes in on-time or off-time on the Stroop test before and two hours after sedatives, and there was no significant difference among the 3 treatment groups.","['advanced cirrhotic patients', 'liver cirrhosis', 'advanced liver cirrhosis', '60 consecutive advanced cirrhotic patients who underwent upper gastrointestinal endoscopy']","['sedative endoscopy', 'midazolam, propofol, or combination therapy', 'midazolam', 'midazolam, propofol, and combination therapy', 'midazolam, propofol, or the combination group, and underwent Stroop test']","['Hemodynamic safety and the subjective satisfaction score', 'Time-to-recovery', 'cognitive performance', 'subjective satisfaction', 'risk of cognitive impairment', 'patient satisfaction', 'time or off-time on the Stroop test']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0439686', 'cui_str': 'Cirrhotic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023890', 'cui_str': 'Hepatic Cirrhosis'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}]","[{'cui': 'C0036557', 'cui_str': 'Sedatives'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}]",60.0,0.135558,"Patients did not show significant changes in on-time or off-time on the Stroop test before and two hours after sedatives, and there was no significant difference among the 3 treatment groups.","[{'ForeName': 'Jeong-Ju', 'Initials': 'JJ', 'LastName': 'Yoo', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Soonchunhyang University school of medicine Bucheon Hospital, Bucheon, Korea.'}, {'ForeName': 'Hyeon Jeong', 'Initials': 'HJ', 'LastName': 'Goong', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Soonchunhyang University school of medicine Bucheon Hospital, Bucheon, Korea.'}, {'ForeName': 'Ji Eun', 'Initials': 'JE', 'LastName': 'Moon', 'Affiliation': 'Department of Biostatistics, Clinical Trial Center, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.'}, {'ForeName': 'Sang Gyune', 'Initials': 'SG', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Soonchunhyang University school of medicine Bucheon Hospital, Bucheon, Korea.'}, {'ForeName': 'Young Seok', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Soonchunhyang University school of medicine Bucheon Hospital, Bucheon, Korea. liverkys@schmc.ac.kr.'}]",Scientific reports,['10.1038/s41598-019-52897-w']
1134,31727962,Taxane-based Chemotherapy Induced Androgen Receptor Splice Variant 7 in Patients with Castration-Resistant Prostate Cancer: A Tissue-based Analysis.,"In total, 95 prostate cancer (Pca) patients who underwent transurethral resection of the prostate from 2000 to 2013 were assigned to four groups: Group 1, hormone-naïve and T1a or T1b Pca (n = 17); Group 2, hormone-sensitive and metastatic Pca (n = 33); Group 3, chemo-naïve castration-resistant Pca (CRPC), (n = 18); and Group 4, CRPC with chemotherapy (n = 27). Full-length androgen receptor (ARfl) transcript levels significantly increased from Group 1 through to Group 3 (p = 0.045), but decreased from Group 3 through to Group 4. AR splice variant 7 (ARV7) and glucocorticoid receptor (GR) transcript levels significantly increased from Group 1 through to Group 4 (p = 0.002 and 0.049, respectively). Kaplan-Meier curve revealed that the high transcript level of these three receptors resulted in significantly poorer cancer-specific survival (CSS) than that by low transcript level, although Cox regression analysis revealed that the ARV7 level alone was an independent prognostic factor for CSS in CRPC patients (high vs. low: hazard ratio, 1.897; 95% confidence interval, 1.102-3.625; p = 0.042). In conclusion, ARV7 and GR transcript levels significantly increase as Pca progresses to CRPC.",2019,"ARfl) transcript levels significantly increased from Group 1 through to Group 3 (p = 0.045), but decreased from Group 3 through to Group 4.","['95 prostate cancer (Pca) patients who underwent transurethral resection of the prostate from 2000 to 2013', 'Patients with Castration-Resistant Prostate Cancer']","['hormone-naïve and T1a or T1b', 'CRPC with chemotherapy', 'chemo-naïve castration-resistant Pca (CRPC', 'Taxane-based Chemotherapy', 'Full-length androgen receptor ']","['ARV7 and GR transcript levels', 'ARfl) transcript levels', 'poorer cancer-specific survival (CSS', 'AR splice variant 7 (ARV7) and glucocorticoid receptor (GR) transcript levels']","[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}]","[{'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0034786', 'cui_str': 'Testosterone Receptor'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0034809', 'cui_str': 'Glucocorticoid Receptor'}]",2013.0,0.0268213,"ARfl) transcript levels significantly increased from Group 1 through to Group 3 (p = 0.045), but decreased from Group 3 through to Group 4.","[{'ForeName': 'Myungsun', 'Initials': 'M', 'LastName': 'Shim', 'Affiliation': 'Department of Urology, Hallym University College of Medicine, Hallym University Sacred Heart Hospital, 22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, 14068, South Korea.'}, {'ForeName': 'Yunlim', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Institute for Innovative Cancer Research, Asan Institute for Life Science, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Yangsoon', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'Department of Pathology, University of Ulsan College of Medicine, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Hanjong', 'Initials': 'H', 'LastName': 'Ahn', 'Affiliation': 'Department of Urology, University of Ulsan College of Medicine, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea. hjahn@amc.seoul.kr.'}]",Scientific reports,['10.1038/s41598-019-53280-5']
1135,31036397,Everolimus Eluting Stents in Patients with Diabetes Mellitus and Chronic Kidney Disease: Insights from the TUXEDO Trial.,"BACKGROUND


Patients with diabetes and those with chronic kidney disease (CKD) are at increased risk of cardiovascular events. Everolimus eluting stents (EES) have been shown to be superior to paclitaxel eluting stents (PES) in patients with diabetes. However, it is not known if EES is as beneficial in diabetic patients with CKD compared with those without CKD.
METHODS AND RESULTS


Patients enrolled in the TUXEDO-India trial, which is a clinical trial of patients with diabetes and coronary artery disease (CAD) randomly assigned to EES vs. thin-strut PES (Taxus Element), with data on baseline renal function were selected. CKD was defined as an estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m 2  using the Cockcroft-Gault formula. Primary outcome was target vessel failure (TVF-defined as cardiac death, TV myocardial infarction (MI) or ischemia driven TV revascularization) at 1 year. Various secondary outcomes including stent thrombosis were evaluated. Among the 1821 patients with diabetes included in this analysis, 344 (19%) had CKD. In a propensity score adjusted analysis, patients with CKD had a significant increase in MACE (HR = 2.02; 95% CI 1.17-3.50; P = 0.01); death/MI/TVR (HR = 1.99; 95% CI 1.18-3.34; P = 0.009); death/MI (HR = 2.31; 95% CI 1.30-4.08; P = 0.004); cardiac death/MI (HR = 2.40; 95% CI 1.31-4.42; P = 0.005); death (HR = 2.88; 95% CI 1.35-6.13; P = 0.006) driven by an increase in cardiac death (HR = 3.33; 95% CI 1.42-7.83; P = 0.006) when compared with those without CKD. However, stent related events (TV-MI, TVR, TLR and stent thrombosis) were not different between CKD and non CKD groups. A significant interaction between CKD status and stent type (EES vs. PES) was noted for the outcomes of TVF (P interaction  = 0.046), MACE (P interaction  = 0.02), cardiac death or MI (P interaction  = 0.05), non-target vessel related MI (P interaction  = 0.04), non-Q-wave MI (P interaction  = 0.03) and deaths/MI/TVR (P interaction  = 0.04) such that EES was superior to PES in the non-CKD cohort but not in the CKD cohort.
CONCLUSIONS


In subjects with diabetes, CKD is an independent predictor of adverse cardiovascular outcomes including increased risk of death driven largely by non-stent related events. While EES was superior to PES in patients without CKD, this was not the case in those with CKD (Clinical Trials Registry-India number, CTRI/2011/06/001830).",2019,"However, stent related events (TV-MI, TVR, TLR and stent thrombosis) were not different between CKD and non CKD groups.","['patients with diabetes', 'Patients with diabetes and those with chronic kidney disease (CKD', 'diabetic patients with CKD', '1821 patients with diabetes included in this analysis, 344 (19%) had CKD', 'Patients enrolled in the TUXEDO-India trial, which is a clinical trial of patients with diabetes and coronary artery disease (CAD) randomly assigned to', 'patients with diabetes mellitus and chronic kidney disease']","['EES', 'EES vs. thin-strut PES (Taxus Element', 'Everolimus eluting stents (EES', 'Everolimus eluting stents', 'paclitaxel eluting stents (PES']","['MACE', 'stent thrombosis', 'cardiac death', 'stent related events (TV-MI, TVR, TLR and stent thrombosis', 'glomerular filtration rate (eGFR', 'cardiac death or MI', 'target vessel failure (TVF-defined as cardiac death, TV myocardial infarction (MI) or ischemia driven TV revascularization', 'deaths/MI/TVR', 'cardiac death/MI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C0330199', 'cui_str': 'Taxus'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",1821.0,0.16802,"However, stent related events (TV-MI, TVR, TLR and stent thrombosis) were not different between CKD and non CKD groups.","[{'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': 'New York University School of Medicine, New York, NY, USA. Electronic address: sripalbangalore@gmail.com.'}, {'ForeName': 'Rajpal', 'Initials': 'R', 'LastName': 'Abhaichand', 'Affiliation': 'Department of Cardiology, L.R.G. Naidu Cardiology Research Institute and Clinic, Kuppuswamy Naidu Memorial Hospital, Coimbatore, India.'}, {'ForeName': 'Ajit', 'Initials': 'A', 'LastName': 'Mullasari', 'Affiliation': 'Department of Cardiology, The Madras Medical Mission, Chennai, India.'}, {'ForeName': 'Rajneesh', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': 'Department of Cardiology, Sir Ganga Ram Hospitals, New Delhi, India.'}, {'ForeName': 'R K Prem', 'Initials': 'RKP', 'LastName': 'Chand', 'Affiliation': 'Department of Cardiology, Krishna Institute of Medical Sciences, Secunderabad, India.'}, {'ForeName': 'Priyadarshini', 'Initials': 'P', 'LastName': 'Arambam', 'Affiliation': 'Batra Hospital and Medical Research Center, New Delhi, India.'}, {'ForeName': 'Upendra', 'Initials': 'U', 'LastName': 'Kaul', 'Affiliation': 'Batra Hospital and Medical Research Center, New Delhi, India.'}]",Cardiovascular revascularization medicine : including molecular interventions,['10.1016/j.carrev.2019.02.017']
1136,31579987,"Disease aetiology-based design of multifunctional microemulsion eye drops for moderate or severe dry eye: a randomized, quadruple-masked and active-controlled clinical trial.","PURPOSE


To assess the safety and efficacy of multi-ingredient sacha inchi microemulsion (SIME) eye drops designed to target (1) tear film instability, (2) tear hyperosmolarity, and (3) ocular surface damage and inflammation in moderate or severe dry eye.
METHODS


This randomized, quadruple-masked, active-controlled parallel study in 64 adult patients comprised three parts. Part 1 (n = 3): one eye was treated with SIME for one day. Part 2 (n = 9): randomized eyes were treated with SIME and 0.2% hyaluronic acid (HA) control eye drops 3 times a day for 10 days. Part 3 (n = 26 + 26): randomized treatment was applied on both eyes 3 times a day for 30 days. OSDI change was tested for superiority of SIME over HA. Ocular assessments were performed at baseline and after the last dose.
RESULTS


Both treatments were well tolerated without adverse device effects. Tear film break-up time (p = 0.0025) and ocular protection index (p = 0.0026; change vs. HA, p = 0.047) increased significantly with SIME after 30 days. Tear osmolarity decreased more in SIME than in the HA group and significantly with both eye drops in hyperosmolar subgroups. Corneal (p = 0.014) and nasal conjunctival staining (p = 0.043) were reduced with SIME in per-protocol patients (n = 24). Conjunctival (p = 0.001) and lid redness (p = 0.012) decreased with SIME in all patients (n = 26). Symptoms decreased by about 25 OSDI units with both treatments (p < 0.0001) and with nonsignificant difference between treatments.
CONCLUSIONS


Sacha inchi microemulsion (SIME) proved safe and efficacious in improving each aetiologic factor for dry eye as revealed through objective tests. Hyperosmolar stress dominating blink cycles must be disrupted by biophysical protection of the ocular surface to facilitate resolution of cellular damage and inflammation, and relief of ocular symptoms.",2020,"Symptoms decreased by about 25 OSDI units with both treatments (p < 0.0001) and with nonsignificant difference between treatments.
","['moderate or severe dry eye', '64 adult patients comprised three parts']","['multifunctional microemulsion eye drops', 'SIME and 0.2% hyaluronic acid (HA) control eye', 'multi-ingredient sacha inchi microemulsion (SIME', 'Sacha inchi microemulsion (SIME']","['Tear film break-up time', 'ocular protection index', 'tolerated without adverse device effects', 'Tear osmolarity decreased more in SIME', 'lid redness', 'Symptoms', 'nasal conjunctival staining', 'safety and efficacy', 'OSDI change']","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}]","[{'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C3266262', 'cui_str': 'Multi'}]","[{'cui': 'C0429495', 'cui_str': 'Tear film break-up time (observable entity)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0029387', 'cui_str': 'Osmolarity'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C3203718', 'cui_str': 'Conjunctival staining'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",64.0,0.127677,"Symptoms decreased by about 25 OSDI units with both treatments (p < 0.0001) and with nonsignificant difference between treatments.
","[{'ForeName': 'Jarmo', 'Initials': 'J', 'LastName': 'Laihia', 'Affiliation': 'Finnsusp Ltd, Lieto, Finland.'}, {'ForeName': 'Riikka', 'Initials': 'R', 'LastName': 'Järvinen', 'Affiliation': 'Finnsusp Ltd, Lieto, Finland.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Wylęgała', 'Affiliation': 'Department of Ophthalmology, District Railway Hospital Katowice, Katowice, Poland.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Kaarniranta', 'Affiliation': 'Department of Ophthalmology, Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland.'}]",Acta ophthalmologica,['10.1111/aos.14252']
1137,32407272,Influence of Rifampicin Pre-treatment on the In Vivo Pharmacokinetics of Metoclopramide in Pakistani Healthy Volunteers Following Concurrent Oral Administration.,"BACKGROUND


Metoclopramide is metabolized by various cytochrome P450 (CYP) enzymes such as CYP3A4, CYP1A2, CYP2D6, CYP2C9, and CYP2C19. Rifampicin is a nonselective inducer of P-glycoprotein (P-gp) and CYP enzymes such as CYP3A4 and others.
OBJECTIVE


This study was aimed at the evaluation of rifampicin's enzyme induction effect on the pharmacokinetic parameters of orally administered metoclopramide.
METHOD


This randomized, single-blind, two-phase cross-over pharmacokinetic study separated by a 4-week wash-out period was conducted at a single center in Pakistan. It involved twelve Pakistani healthy male volunteers (non-smokers) divided into two groups. In the reference phase, each volunteer received a single oral dose of 20 mg metoclopramide (Maxolon 10 mg, GlaxoSmithKline, Pakistan), while in the rifampicin-treated phase, each volunteer received 600 mg rifampicin once daily for 6 days through oral route. On day 6, metoclopramide (20 mg) was administered 2 hours after the last pretreatment dose of rifampicin. The serial blood samples were collected on predetermined time points (0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, and 18 h) and analyzed using a validated HPLC method for the determination of pharmacokinetic parameters, i.e. Cmax, Tmax, and AUC0-∞ of metoclopramide. The whole study was monitored by an unblinded clinician for the purpose of volunteer's health safety.
RESULTS


All the volunteers participated in the study until the end. Twelve healthy Pakistani males having to mean age 26.0 (range 20.6-34.1) years and body mass index 25.1 (range 16.2-31.5) kg/m2 were included in this study after taking written informed consent. Rifampicin significantly (P < 0.05) decreased the mean Cmax, AUC0-∞ and T1/2 of metoclopramide by 35%, 68%, and 44%, respectively. The laboratory tests did not reveal any significant change in the biochemical, physical, hematological, or urinalytical values before and after metoclopramide treatment. None of the volunteers complained of any discomfort during the study.
CONCLUSION


Rifampicin noticeably decreased the concentration of plasma metoclopramide. These results give in vivo confirmation of the CYP3A4 involvement in the metoclopramide metabolism, in addition to CYP2D6. Therefore, metoclopramide pharmacokinetics may be clinically affected by rifampicin and other potent enzyme inducers.",2020,"The laboratory tests did not reveal any significant change in the biochemical, physical, hematological, or urinalytical values before and after metoclopramide treatment.","['Pakistani Healthy Volunteers Following Concurrent Oral Administration', 'twelve Pakistani healthy male volunteers (non-smokers', 'Twelve healthy Pakistani males having to mean age 26.0 (range 20.6-34.1) years and body mass index 25.1 (range']","['Rifampicin', 'Rifampicin Pre-treatment', 'metoclopramide', 'rifampicin', 'Metoclopramide', 'metoclopramide (Maxolon 10 mg, GlaxoSmithKline, Pakistan']","['biochemical, physical, hematological, or urinalytical values', 'concentration of plasma metoclopramide', 'pharmacokinetic parameters, i.e. Cmax, Tmax, and AUC0-∞ of metoclopramide', 'serial blood samples', 'mean Cmax, AUC0-∞']","[{'cui': 'C0240620', 'cui_str': 'Pakistani'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0699913', 'cui_str': 'Maxolon'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",12.0,0.0264346,"The laboratory tests did not reveal any significant change in the biochemical, physical, hematological, or urinalytical values before and after metoclopramide treatment.","[{'ForeName': 'Iram', 'Initials': 'I', 'LastName': 'Kaukab', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Bahauddin Zakariya University, Multan. Pakistan.'}, {'ForeName': 'Syed Nisar Hussain', 'Initials': 'SNH', 'LastName': 'Shah', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Bahauddin Zakariya University, Multan. Pakistan.'}, {'ForeName': 'Muhammad Asad', 'Initials': 'MA', 'LastName': 'Abrar', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Bahauddin Zakariya University, Multan. Pakistan.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Anwer', 'Affiliation': 'Saulat Institute of Pharmaceutical Sciences, Quaid-e-Azam University, Islamabad. Pakistan.'}, {'ForeName': 'Ghulam', 'Initials': 'G', 'LastName': 'Murtaza', 'Affiliation': 'Department of Pharmacy, COMSATS Institute of Information Technology, Lahore. Pakistan.'}]",Current drug metabolism,['10.2174/1389200221666200514132654']
1138,30676818,"Rationale and design for fractional microablative CO 2  laser versus photothermal non-ablative erbium:YAG laser for the management of genitourinary syndrome of menopause: a non-inferiority, single-blind randomized controlled trial.","Genitourinary syndrome of menopause (GSM) is a common condition affecting up to 50% of postmenopausal women and up to 70% of postmenopausal breast cancer survivors. GSM is a chronic condition with a significant impact on sexual health and quality of life. The mainstay of treatment has been with symptomatic relief using topical emollients or lubricants. Second-line treatment is with topical vaginal estrogens to restore the physiology of the vaginal epithelium. For some, the latter is not suitable or acceptable. Newer treatments with ospemifene and vaginal lasers have now been introduced. The two main types of laser currently used for the treatment of GSM are the fractional microablative CO 2  laser and the non-ablative photothermal erbium:YAG laser. We present a study protocol for a multicenter, prospective, non-inferiority, single-blinded, randomized controlled trial comparing the fractional microablative CO 2  laser versus the photothermal non-ablative erbium:YAG laser for the management of GSM. We will recruit 88 postmenopausal women across two sites who will be randomized to one of the two laser groups. Participants will all have GSM symptoms and a Vaginal Health Index Score < 15. All participants will receive an active treatment. Each participant will receive three applications of vaginal laser 1 month apart and will be followed up at 1 month, 6 months, and 12 months. Our primary outcomes will look at all changes of GSM symptoms (dryness, dyspareunia, itching, burning, dysuria, frequency, urgency), urinary incontinence (if present), and overall sexual satisfaction. Both subjective and objective means will be used to assess participants. The findings of this trial have the potential to allow clinicians and women suffering from GSM to make an informed decision when opting for a specific laser type. The trial will add to the current growing body of evidence for the safe use of vaginal lasers in GSM as an alternative treatment. We hope this trial will provide robust and long-term data for the safe use of both lasers.",2019,The trial will add to the current growing body of evidence for the safe use of vaginal lasers in GSM as an alternative treatment.,"['genitourinary syndrome of menopause', '88 postmenopausal women across two sites who will be randomized to one of the two laser groups', 'postmenopausal breast cancer survivors', 'Genitourinary syndrome of menopause (GSM']","['GSM', 'ospemifene and vaginal lasers', 'fractional microablative CO 2  laser versus photothermal non-ablative erbium:YAG laser', 'topical vaginal estrogens', 'fractional microablative CO 2  laser versus the photothermal non-ablative erbium:YAG laser']","['GSM symptoms and a Vaginal Health Index Score', 'GSM symptoms (dryness, dyspareunia, itching, burning, dysuria, frequency, urgency), urinary incontinence (if present), and overall sexual satisfaction', 'sexual health and quality of life']","[{'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0567312', 'cui_str': 'Menopause present (finding)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0069228', 'cui_str': 'O-(glucuronic acid 2-sulfate)-(1--4)-O-(2,5)-anhydromannitol 6-sulfate'}]","[{'cui': 'C0069228', 'cui_str': 'O-(glucuronic acid 2-sulfate)-(1--4)-O-(2,5)-anhydromannitol 6-sulfate'}, {'cui': 'C1313616', 'cui_str': 'Ospemifene'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0014688', 'cui_str': 'Erbium'}, {'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C0069228', 'cui_str': 'O-(glucuronic acid 2-sulfate)-(1--4)-O-(2,5)-anhydromannitol 6-sulfate'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse (finding)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0871356', 'cui_str': 'Sexual Satisfaction'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0034380'}]",88.0,0.112239,The trial will add to the current growing body of evidence for the safe use of vaginal lasers in GSM as an alternative treatment.,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Flint', 'Affiliation': ""a King's College Hospital , London, UK.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Cardozo', 'Affiliation': ""a King's College Hospital , London, UK.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Grigoriadis', 'Affiliation': ""b First Department of Obstetrics and Gynecology , National and Kapodistrian University of Athens, 'Alexandra' Hospital , Athens , Greece.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rantell', 'Affiliation': ""a King's College Hospital , London, UK.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pitsouni', 'Affiliation': 'c First Department of Obstetrics and Gynecology , National and Kapodistrian University of Athens , Athens , Greece.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Athanasiou', 'Affiliation': 'c First Department of Obstetrics and Gynecology , National and Kapodistrian University of Athens , Athens , Greece.'}]",Climacteric : the journal of the International Menopause Society,['10.1080/13697137.2018.1559806']
1139,31034591,Effects of a Home-based Exercise Program on Anxiety and Mood Disturbances in Older Adults with Cancer Receiving Chemotherapy.,"BACKGROUND/OBJECTIVE


Exercise interventions improve anxiety and mood disturbances in patients with cancer. However, studies are limited in older adults with cancer. We assessed the effects of exercise on anxiety, mood, and social and emotional well-being in older patients with cancer during their first 6 weeks of chemotherapy.
DESIGN


Exploratory secondary analysis of a randomized controlled trial (RCT).
SETTING


Community oncology practices.
PARTICIPANTS


Older patients (aged 60 years or older) undergoing chemotherapy (N = 252).
INTERVENTION


Patients were randomized to Exercise for Cancer Patients (EXCAP) or usual care (control) for the first 6 weeks of chemotherapy. EXCAP is a home-based, low- to moderate-intensity progressive walking and resistance training program.
MEASUREMENTS


Analysis of covariance, with study arm as the factor, baseline value as the covariate, and study arm × baseline interaction, was used to evaluate arm effects on postintervention anxiety (State Trait Anxiety Inventory [STAI]), mood (Profile of Mood States [POMS]), and social and emotional well-being (Functional Assessment of Cancer Therapy-General subscales) after 6 weeks.
RESULTS


Median age was 67 years; 77% had breast cancer. Statistically significant group differences were observed in the STAI score (P = .001), POMS score (P = .022), social well-being (P = .002), and emotional well-being (P = .048). For each outcome, EXCAP patients with worse baseline scores had larger improvements at 6 weeks; these improvements were clinically significant for STAI score and social well-being.
CONCLUSIONS


Among older cancer patients receiving chemotherapy, a 6-week structured exercise program improved anxiety and mood, especially among those participants with worse baseline symptoms. Additional RCTs are needed to confirm these findings and evaluate the appropriate exercise prescription for managing anxiety, mood, and well-being in this patient population. J Am Geriatr Soc 67:1005-1011, 2019.",2019,"For each outcome, EXCAP patients with worse baseline scores had larger improvements at 6 weeks; these improvements were clinically significant for STAI score and social well-being.
","['Older patients (aged 60\u2009years or older) undergoing chemotherapy (N\u2009=\u2009252', 'older adults with cancer', 'Median age was 67\u2009years; 77% had breast cancer', 'older cancer patients receiving', 'Older Adults with Cancer Receiving Chemotherapy', 'patients with cancer', 'Community oncology practices', 'older patients with cancer during their first 6 weeks of chemotherapy']","['structured exercise program', 'chemotherapy', 'EXCAP', 'Exercise for Cancer Patients (EXCAP) or usual care (control) for the first 6 weeks of chemotherapy', 'Home-based Exercise Program', 'Exercise interventions']","['POMS score', 'anxiety, mood, and social and emotional well-being', 'STAI score', 'STAI score and social well-being', 'anxiety and mood', 'Anxiety and Mood Disturbances', 'anxiety and mood disturbances', 'postintervention anxiety (State Trait Anxiety Inventory [STAI]), mood (Profile of Mood States [POMS]), and social and emotional well-being (Functional Assessment of Cancer Therapy-General subscales']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states (assessment scale)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",,0.0455002,"For each outcome, EXCAP patients with worse baseline scores had larger improvements at 6 weeks; these improvements were clinically significant for STAI score and social well-being.
","[{'ForeName': 'Kah Poh', 'Initials': 'KP', 'LastName': 'Loh', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Kleckner', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Po-Ju', 'Initials': 'PJ', 'LastName': 'Lin', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Supriya G', 'Initials': 'SG', 'LastName': 'Mohile', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Beverly E', 'Initials': 'BE', 'LastName': 'Canin', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Flannery', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Chunkit', 'Initials': 'C', 'LastName': 'Fung', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Dunne', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Bautista', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Culakova', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Amber S', 'Initials': 'AS', 'LastName': 'Kleckner', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Luke J', 'Initials': 'LJ', 'LastName': 'Peppone', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Janelsins', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McHugh', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Conlin', 'Affiliation': 'Pacific Cancer Research Consortium National Cancer Institute Community Oncology Research Program (NCORP), Seattle, Washington.'}, {'ForeName': 'Jonathan K', 'Initials': 'JK', 'LastName': 'Cho', 'Affiliation': 'Hawaii Minority Underserved National Cancer Institute Community Oncology Research Program (NCORP), Honolulu, Hawaii.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Kasbari', 'Affiliation': 'Southeast Clinical Oncology Research Consortium, Winston-Salem, North Carolina.'}, {'ForeName': 'Benjamin T', 'Initials': 'BT', 'LastName': 'Esparaz', 'Affiliation': 'Heartland National Cancer Institute Community Oncology Research Program (NCORP), Decatur, Illinois.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Kuebler', 'Affiliation': 'Columbus National Cancer Institute Community Oncology Research Program (NCORP), Columbus, Ohio.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Mustian', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.15951']
1140,32410697,Comparison of the clinical and cost effectiveness of two management strategies (rehabilitation versus surgical reconstruction) for non-acute anterior cruciate ligament (ACL) injury: study protocol for the ACL SNNAP randomised controlled trial.,"BACKGROUND


Anterior cruciate ligament (ACL) rupture is a common knee injury that can lead to poor quality of life, decreased activity and increased risk of secondary osteoarthritis of the knee. Management of patients with a non-acute ACL injury can include a non-surgical (rehabilitation) or surgical (reconstruction) approach. However, insufficient evidence to guide treatment selection has led to high variation in treatment choice for patients with non-acute presentation of ACL injury. The objective of the ACL SNNAP trial is to determine in patients with non-acute anterior cruciate ligament deficiency (ACLD) whether a strategy of non-surgical management (rehabilitation) (with option for later ACL reconstruction only if required) is more clinically effective and cost effective than a strategy of surgical management (reconstruction) without prior rehabilitation with all patients followed up at 18 months.
METHODS


The study is a pragmatic, multi-centre, superiority, randomised controlled trial with two-arm parallel groups and 1:1 allocation. Patients with a symptomatic non-acute ACL deficient knee will be randomised to either non-surgical management (rehabilitation) or surgical management (reconstruction). We aim to recruit 320 patients from approximately 30 secondary care orthopaedic units from across the United Kingdom. Randomisation will occur using a web-based randomisation system. Blinding of patients and clinicians to treatment allocation will not be possible because of the nature of the interventions. Participants will be followed up via self-reported questionnaires at 6, 12 and 18 months. The primary outcome is the Knee injury and Osteoarthritis Outcome Score (KOOS) at 18 months post randomisation. Secondary outcomes will include a return to sport/activity, intervention-related complications, patient satisfaction, expectations of activity, generic health quality of life, knee specific quality of life and resource usage.
DISCUSSION


At present, no evidence-based treatment of non-acute ACL deficiency exists, particularly in the NHS. Moreover, little consensus exists on the management approach for these patients. The proposed trial will address this gap in knowledge regarding the clinical and cost effectiveness of ACL treatment and inform future standards of care for this condition.
TRIAL REGISTRATION


ISRCTN: 10110685. Registered on 16 November 2016. ClinicalTrials.gov: NCT02980367. Registered in December 2016.",2020,"Secondary outcomes will include a return to sport/activity, intervention-related complications, patient satisfaction, expectations of activity, generic health quality of life, knee specific quality of life and resource usage.
","['Anterior cruciate ligament (ACL) rupture', '320 patients from approximately 30 secondary care orthopaedic units from across the United Kingdom', 'patients with a non-acute ACL injury can include a non-surgical (rehabilitation) or surgical (reconstruction) approach', 'non-acute anterior cruciate ligament', 'ACL) injury', 'patients with non-acute anterior cruciate ligament deficiency (ACLD', 'Patients with a symptomatic non-acute ACL deficient knee', 'patients with non-acute presentation of ACL injury']","['ACL SNNAP', 'non-surgical management (rehabilitation) or surgical management (reconstruction', 'management strategies (rehabilitation versus surgical reconstruction']","['Knee injury and Osteoarthritis Outcome Score (KOOS', 'return to sport/activity, intervention-related complications, patient satisfaction, expectations of activity, generic health quality of life, knee specific quality of life and resource usage']","[{'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1456574', 'cui_str': 'Injury of anterior cruciate ligament'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0449446', 'cui_str': 'Surgical approach'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}]","[{'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0457083', 'cui_str': 'Usage'}]",,0.109903,"Secondary outcomes will include a return to sport/activity, intervention-related complications, patient satisfaction, expectations of activity, generic health quality of life, knee specific quality of life and resource usage.
","[{'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Davies', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Headington, Oxford, OX3 7LD, UK. loretta.davies@ndorms.ox.ac.uk.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Headington, Oxford, OX3 7LD, UK.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Leal', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Department of Public Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Carlos Morgado', 'Initials': 'CM', 'LastName': 'Areia', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Headington, Oxford, OX3 7LD, UK.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Shirkey', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Headington, Oxford, OX3 7LD, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Jackson', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Campbell', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Department of Public Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Fletcher', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Headington, Oxford, OX3 7LD, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Carr', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Headington, Oxford, OX3 7LD, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Barker', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Headington, Oxford, OX3 7LD, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Monk', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Headington, Oxford, OX3 7LD, UK.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': ""O'Leary"", 'Affiliation': 'Royal Berkshire NHS Foundation Trust, Reading, UK.'}, {'ForeName': 'Fares', 'Initials': 'F', 'LastName': 'Haddad', 'Affiliation': 'University College Hospital, London, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Wilson', 'Affiliation': 'University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Price', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Headington, Oxford, OX3 7LD, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Beard', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Headington, Oxford, OX3 7LD, UK.'}]",Trials,['10.1186/s13063-020-04298-y']
1141,32407327,How much is enough? Exploring the dose-response relationship between cash transfers and surgical utilization in a resource-poor setting.,"OBJECTIVE


Cash transfers are a common intervention to incentivize salutary behavior in resource-constrained settings. Many cash transfer studies do not, however, account for the effect of the size of the cash transfer in design or analysis. A randomized, controlled trial of a cash-transfer intervention is planned to incentivize appropriate surgical utilization in Guinea. The aim of the current study is to determine the size of that cash transfer so as to maximize compliance while minimizing cost.
METHODS


Data were collected from nine coastal Guinean hospitals on their surgical capabilities and the cost of receiving surgery. These data were combined with publicly available data about the general Guinean population to create an agent-based model predicting surgical utilization. The model was validated to the available literature on surgical utilization. Cash transfer sizes from 0 to 1,000,000 Guinean francs were evaluated, with surgical compliance as the primary outcome.
RESULTS


Compliance with scheduled surgery increases as the size of a cash transfer increases. This increase is asymptotic, with a leveling in utilization occurring when the cash transfer pays for all the costs associated with surgical care. Below that cash transfer size, no other optima are found. Once a cash transfer completely covers the costs of surgery, other barriers to care such as distance and hospital quality dominate.
CONCLUSION


Cash transfers to incentivize health-promoting behavior appear to be dose-dependent. Maximal impact is likely only to occur when full patient costs are eliminated. These findings should be incorporated in the design of future cash transfer studies.",2020,"This increase is asymptotic, with a leveling in utilization occurring when the cash transfer pays for all the costs associated with surgical care.","['Data were collected from nine coastal Guinean hospitals on their surgical capabilities and the cost of receiving surgery', 'Guinea']",['cash-transfer intervention'],[],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018381', 'cui_str': 'Guinea Republic'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0274983,"This increase is asymptotic, with a leveling in utilization occurring when the cash transfer pays for all the costs associated with surgical care.","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Strader', 'Affiliation': 'Program in Global Surgery and Social Change, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Ashby', 'Affiliation': 'Program in Global Surgery and Social Change, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Vervoort', 'Affiliation': 'Program in Global Surgery and Social Change, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Aref', 'Initials': 'A', 'LastName': 'Ebrahimi', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Shoghi', 'Initials': 'S', 'LastName': 'Agbortoko', 'Affiliation': 'Harvard College, Cambridge, MA, United States of America.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Harvard College, Cambridge, MA, United States of America.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Reiner', 'Affiliation': 'Harvard Graduate School of Education, Cambridge, MA, United States of America.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Zeme', 'Affiliation': 'Harvard College, Cambridge, MA, United States of America.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Shrime', 'Affiliation': 'Program in Global Surgery and Social Change, Harvard Medical School, Boston, MA, United States of America.'}]",PloS one,['10.1371/journal.pone.0232761']
1142,32410703,Urinary angiotensinogen as a surrogate marker predicting the antiproteinuric effects of angiotensin receptor blockers in patients with overt proteinuria: a multicenter prospective study.,"BACKGROUND


Although urinary angiotensinogen (AGT) and renin reflect intrarenal renin-angiotensin system activity and are enhanced in proteinuric chronic kidney disease, the clinical value of urinary AGT and renin levels during antiproteinuric treatment has yet to be determined. We investigated the clinical usefulness of initial urinary AGT or renin to determine the antiproteinuric effects of angiotensin receptor blockers (ARBs).
METHODS


This multicenter, prospective, single-arm study included 205 patients with overt proteinuria (urinary protein/creatinine ratio [uPCR] ≥ 1 mg/mg) enrolled between April 2009 and December 2011. All patients were treated with valsartan. The urinary AGT/creatinine ratio (uAGT/Cr) was measured at the baseline and 24 weeks, and the renin/creatinine ratio (uR/Cr) was measured at the baseline. Fifty-six patients were followed-up for 5 years.
RESULTS


The mean age was 47.6 years and 51.2% were male. The mean uPCR was 2.32 mg/mg and the mean eGFR was 63.2 mL/min/1.73m 2 . Natural logarithms (ln) (uAGT/Cr), ln(uR/Cr), and diabetes mellitus were associated with proteinuria decrement (decrease in uPCR ≥1 mg/mg). Ln(uAGT/Cr) was an independent predictor for proteinuria decrement (OR 1.372, 95% CI, 1.068-1.762, P = 0.013). Among the 56 patients followed-up for 5 years, Δln(uAGT/Cr) at 24 weeks was an independent predictor for uPCR < 1 mg/mg at 5 years (OR 0.379, 95% CI, 0.20-0.715, P = 0.003).
CONCLUSIONS


Our study demonstrates the potential role of both baseline urinary AGT and changes in urinary AGT during the initial 24 weeks as surrogate markers predicting the antiproteinuric effects of ARBs in patients with overt proteinuria.",2020,"Ln(uAGT/Cr) was an independent predictor for proteinuria decrement (OR 1.372, 95% CI, 1.068-1.762, P = 0.013).","['205 patients with overt proteinuria (urinary protein/creatinine ratio [uPCR]\u2009≥\u20091\u2009mg/mg) enrolled between April 2009 and December 2011', 'patients with overt proteinuria', 'Fifty-six patients were followed-up for 5\u2009years', 'The mean age was 47.6\u2009years and 51.2% were male']","['valsartan', 'angiotensin receptor blockers', 'angiotensin receptor blockers (ARBs']","['mean uPCR', 'urinary AGT/creatinine ratio (uAGT/Cr', 'proteinuria decrement', 'Natural logarithms (ln) (uAGT/Cr), ln(uR/Cr), and diabetes mellitus', 'renin/creatinine ratio (uR/Cr']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0428627', 'cui_str': 'Protein/creatinine ratio measurement'}, {'cui': 'C1319635', 'cui_str': 'mg/mg'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003017', 'cui_str': 'Angiotensinogen'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0002555', 'cui_str': 'Aminoglutethimide'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035094', 'cui_str': 'Renin'}]",205.0,0.0182478,"Ln(uAGT/Cr) was an independent predictor for proteinuria decrement (OR 1.372, 95% CI, 1.068-1.762, P = 0.013).","[{'ForeName': 'Junseok', 'Initials': 'J', 'LastName': 'Jeon', 'Affiliation': 'Division of Nephrology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Do Hee', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Division of Nephrology, Department of Medicine, Chungbuk National University Hospital, Cheongju, 28644, Republic of Korea.'}, {'ForeName': 'Hye Ryoun', 'Initials': 'HR', 'LastName': 'Jang', 'Affiliation': 'Division of Nephrology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea. shinehr@gmail.com.'}, {'ForeName': 'Jung Eun', 'Initials': 'JE', 'LastName': 'Lee', 'Affiliation': 'Division of Nephrology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Wooseong', 'Initials': 'W', 'LastName': 'Huh', 'Affiliation': 'Division of Nephrology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Hye-Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Division of Nephrology, Department of Medicine, Chungbuk National University Hospital, Cheongju, 28644, Republic of Korea.'}, {'ForeName': 'Dae Joong', 'Initials': 'DJ', 'LastName': 'Kim', 'Affiliation': 'Division of Nephrology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Yoon-Goo', 'Initials': 'YG', 'LastName': 'Kim', 'Affiliation': 'Division of Nephrology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}]",BMC nephrology,['10.1186/s12882-020-01825-6']
1143,31003961,"Optimal dilation time for combined small endoscopic sphincterotomy and balloon dilation for common bile duct stones: a multicentre, single-blinded, randomised controlled trial.","BACKGROUND


Endoscopic sphincterotomy is the established treatment for common bile duct stones. Balloon dilation offers an alternative. Prolonged dilation (300 s) with a 10 mm diameter balloon decreases the occurrence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). We aimed to determine the optimal duration of dilation for combined endoscopic sphincterotomy and balloon dilation for the removal of common bile duct stones.
METHODS


We did a multicentre, single-blinded, randomised controlled trial at 15 tertiary surgical centres in China. Eligible patients (≥18 years) with native papilla and common bile duct stones (≤1·5 cm in size and <2 cm in diameter) undergoing ERCP were randomly assigned (1:1:1:1:1) to receive balloon dilation for 0, 30, 60, 180, or 300 s after deep bile duct cannulation. Randomisation was done by an independent statistician using a computer-generated randomisation list with a block size of ten, stratified by centre. Patients and outcome assessors, but not endoscopists and investigators, were masked to treatment allocation. Balloon dilation was done with controlled radial expansion balloons according to common bile duct stone size. Stones were removed using stone retrieval balloons or baskets. The primary endpoint was overall frequency of post-ERCP pancreatitis. The primary efficacy analysis and safety analyses were done in the modified intention-to-treat population, which included all randomly assigned patients with successful cannulation, but excluded those who withdrew consent after randomisation. This study was registered with ClinicalTrials.gov, number NCT02510495, and is complete.
FINDINGS


Between July 29, 2015, and Dec 1, 2017, 3721 consecutive patients with common bile duct stones were recruited, 1718 of whom were excluded. The remaining 2003 patients underwent a small (3-5 mm) endoscopic sphincterotomy. 83 patients withdrew consent after the ERCP procedure, thus 1920 patients were included in the modified intention-to-treat analysis (0 s [n=371], 30 s [n=384], 60 s [n=388], 180 s [n=390], and 300 s [n=387]). Overall, post-ERCP pancreatitis occurred in 199 (10%) of 1920 patients (44 [12%] patients in the 0 s group, 28 [7%] in the 30 s group, 32 [8%] in the 60 s group, 36 [9%] in the 180 s group, and 59 [15%] in the 300 s group). Prolonged dilation (300 s) significantly increased the occurrence of post-ERCP pancreatitis compared with shorter balloon dilation (p=0·002). The frequency of post-ERCP pancreatitis was significantly lower in the 30, 60, and 180 s groups than in the 300 s group (relative risk [RR] 0·48, 95% CI 0·31-0·73; p=0·0005 vs the 30 s group; 0·54, 0·36-0·81; p=0·003 vs the 60 s group; 0·61, 0·41-0·89; p=0·01 vs the 180 s group). The frequency of post-ERCP pancreatitis was significantly higher in the 0 s group than the 30 s group (RR 1·62, 1·04-2·56; p=0·03). No difference in stone extraction (all ≥90%) was observed between groups. Following ERCP, 90 (5%) of 1920 patients had acute cholangitis, 14 (<1%) had acute cholecystitis, and five (<1%) had gastrointestinal bleeding, with no significant differences between groups. One (<1%) patient had Stapfer II perforation, which resolved spontaneously with conservative treatment.
INTERPRETATION


A balloon dilation time of 30 s for combined endoscopic sphincterotomy and balloon dilation reduced the frequency of post-ERCP pancreatitis and was determined to be the optimum dilation time for the removal of common bile duct stones.
FUNDING


National Natural Science Foundation of China, Gansu Competitive Foundation Projects for Technology Development and Innovation.",2019,"A balloon dilation time of 30 s for combined endoscopic sphincterotomy and balloon dilation reduced the frequency of post-ERCP pancreatitis and was determined to be the optimum dilation time for the removal of common bile duct stones.
","['Eligible patients (≥18 years) with native papilla and common bile duct stones (≤1·5 cm in size and <2 cm in diameter) undergoing ERCP', 'common bile duct stones', '15 tertiary surgical centres in China', 'Between July 29, 2015, and Dec 1, 2017, 3721 consecutive patients with common bile duct stones were recruited, 1718 of whom were excluded', '83 patients withdrew consent after the ERCP procedure, thus 1920 patients were included in the modified intention-to-treat analysis (0 s [n=371], 30 s [n=384], 60 s [n=388], 180 s [n=390], and 300 s [n=387']","['Balloon dilation', 'balloon dilation', 'combined endoscopic sphincterotomy and balloon dilation', 'Prolonged dilation (300 s) with a 10 mm diameter balloon', 'small endoscopic sphincterotomy and balloon dilation', 'endoscopic retrograde cholangiopancreatography (ERCP', 'endoscopic sphincterotomy', 'endoscopic sphincterotomy and balloon dilation', 'Endoscopic sphincterotomy']","['occurrence of pancreatitis', 'frequency of post-ERCP pancreatitis', 'occurrence of post-ERCP pancreatitis', 'acute cholangitis', 'Prolonged dilation', 'gastrointestinal bleeding', 'Overall, post-ERCP pancreatitis', 'acute cholecystitis', 'overall frequency of post-ERCP pancreatitis', 'stone extraction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0009438', 'cui_str': 'Common Bile Duct Gall Stones'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0085263', 'cui_str': 'Endoscopic Biliary Sphincterotomy'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0267917', 'cui_str': 'Acute cholangitis (disorder)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0149520', 'cui_str': 'Acute Cholecystitis'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}]",3721.0,0.246079,"A balloon dilation time of 30 s for combined endoscopic sphincterotomy and balloon dilation reduced the frequency of post-ERCP pancreatitis and was determined to be the optimum dilation time for the removal of common bile duct stones.
","[{'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Meng', 'Affiliation': 'Department of Special Minimally Invasive Surgery, CHESS Center, The First Hospital of Lanzhou University, Lanzhou, China; Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Leung', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of California, Davis Medical Center and Sacramento Veterans Affairs Medical Center, Sacramento, CA, USA.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Hepatobiliary Surgery Department, Shandong Provincial Third Hospital, Jinan, China.'}, {'ForeName': 'Wence', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China; Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China; Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Leida', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatobiliary Surgery, Southwest Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': ""Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Xue', 'Affiliation': 'Department of Hepatobiliary Surgery, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Minimal Invasive Surgery Centre, Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Minimal Invasive Surgery Centre, Second Xiangya Hospital, Central South University, Changsha, China; Department of Hepatobiliary Surgery, The General Hospital of Ningxia Medical University, Yinchuan, Ningxia, China.'}, {'ForeName': 'Jijun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of General Surgery, Sixth Hospital of Shanxi Medical University (General Hospital of TISCO), Taiyuan, China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Biliary Tract Disease Research, Shanghai, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Yingmei', 'Initials': 'Y', 'LastName': 'Shao', 'Affiliation': 'Department of Hepatobiliary and Hydatid, Digestive and Vascular Surgery Centre, Xinjiang Key Laboratory of Echinococcosis and Liver Surgery Research, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Kailin', 'Initials': 'K', 'LastName': 'Cai', 'Affiliation': 'Gastrointestinal Surgery Department, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Senlin', 'Initials': 'S', 'LastName': 'Hou', 'Affiliation': 'Department of Biliopancreatic Endoscopic Surgery, Second Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Qiyong', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, School of Medicine, Shulan (Hangzhou) Hospital, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Fifth Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China; Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Kexiang', 'Initials': 'K', 'LastName': 'Zhu', 'Affiliation': 'Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China; Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yue', 'Affiliation': 'Department of Special Minimally Invasive Surgery, CHESS Center, The First Hospital of Lanzhou University, Lanzhou, China; Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Haiping', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Hepatobiliary Surgery Department, Shandong Provincial Third Hospital, Jinan, China.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Centre of Minimally Invasive Surgery, Tianjin Nankai Hospital, Tianjin, China.'}, {'ForeName': 'Zhiqing', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Hepatobiliary Surgery, Southwest Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': ""Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Zilong', 'Initials': 'Z', 'LastName': 'Wen', 'Affiliation': 'Department of Hepatobiliary Surgery, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Qunwei', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Minimal Invasive Surgery Centre, Second Xiangya Hospital, Central South University, Changsha, China; Department of Hepatobiliary Surgery, The General Hospital of Ningxia Medical University, Yinchuan, Ningxia, China.'}, {'ForeName': 'Bendong', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Hepatobiliary Surgery, The General Hospital of Ningxia Medical University, Yinchuan, Ningxia, China.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Shao', 'Affiliation': 'Department of General Surgery, Sixth Hospital of Shanxi Medical University (General Hospital of TISCO), Taiyuan, China.'}, {'ForeName': 'Mingning', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Department of General Surgery, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Biliary Tract Disease Research, Shanghai, China.'}, {'ForeName': 'Ruoyan', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Tiemin', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Department of Hepatobiliary and Hydatid, Digestive and Vascular Surgery Centre, Xinjiang Key Laboratory of Echinococcosis and Liver Surgery Research, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Gastrointestinal Surgery Department, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Lichao', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Biliopancreatic Endoscopic Surgery, Second Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Kangjie', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, School of Medicine, The First Affiliated Hospital, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Xiaoliang', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Fifth Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China; Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China; Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Miao', 'Affiliation': 'Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China; Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Zhengfeng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China; Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Jiajia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Xiaowen', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China.'}, {'ForeName': 'Fangzhao', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Lingen', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Azumi', 'Initials': 'A', 'LastName': 'Suzuki', 'Affiliation': 'Department of Gastroenterology, Kyoto Second Red Cross Hospital, Kyoto, Japan.'}, {'ForeName': 'Kiyohito', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Gastroenterology, Kyoto Second Red Cross Hospital, Kyoto, Japan.'}, {'ForeName': 'Ula', 'Initials': 'U', 'LastName': 'Nur', 'Affiliation': 'Department of Public Health, College of Health Sciences, Qatar University Health, Qatar University, Doha, Qatar.'}, {'ForeName': 'Elisabete', 'Initials': 'E', 'LastName': 'Weiderpass', 'Affiliation': 'International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Fifth Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China; Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China; Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, China. Electronic address: drlixun@163.com.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30075-5']
1144,31033228,"Low-Load Resistance Training With Blood-Flow Restriction in Relation to Muscle Function, Mass, and Functionality in Women With Rheumatoid Arthritis.","OBJECTIVE


To evaluate the effects of a low-load resistance training program associated with partial blood-flow restriction in patients with rheumatoid arthritis (RA).
METHODS


Forty-eight women with RA were randomized into 1 of 3 groups: high-load resistance training (HL-RT; 70% 1 repetition maximum [1RM]), low-load resistance training (30% 1RM) with partial blood-flow restriction training (BFRT), and a control group. Patients completed a 12-week supervised training program and were assessed for lower-extremity 1RM, quadriceps cross-sectional area (CSA), physical function (timed-stands test [TST], timed-up-and-go test [TUG], and Health Assessment Questionnaire [HAQ]), and quality of life (Short Form 36 health survey [SF-36]) at baseline and after the intervention.
RESULTS


BFRT and HL-RT were similarly effective in increasing maximum dynamic strength in both leg press (22.8% and 24.2%, respectively; P < 0.0001 for all) and knee extension (19.7% and 23.8%, respectively; P < 0.0001 for all). Quadriceps CSA was also significantly increased in both BFRT and HL-RT (9.5% and 10.8%, respectively; P < 0.0001 for all). Comparable improvements in TST (11.2% and 14.7%; P < 0.0001 for all) and TUG (-6.8% [P < 0.0053] and -8.7% [P < 0.0001]) were also observed in BFRT and HL-RT, respectively. Improvements in both groups were significantly greater than those of the control group (P < 0.05 for all). SF-36 role physical and bodily pain and HAQ scores were improved only in BFRT (45.7%, 22.5%, and -55.9%, respectively; P < 0.05 for all). HL-RT resulted in 1 case of withdrawal and several cases of exercise-induced pain, which did not occur in BFRT.
CONCLUSION


BFRT was effective in improving muscle strength, mass, function, and health-related quality of life in patients with RA, emerging as a viable therapeutic modality in RA management.",2019,"SF-36 role physical, bodily pain and HAQ scores were improved only in BFRT (+45.7%, +22.5% and -55.9%, respectively; all p<0.05).","['Forty-eight women with RA', 'patients with rheumatoid arthritis (RA', 'women with rheumatoid arthritis']","['low-load resistance training program', 'high-load resistance training (HL-RT: 70% one repetition maximum [1RM]); low-load resistance training (30% 1RM) with partial blood flow restriction (BFRT) and control group', 'supervised training program', 'Low-load resistance training with blood flow restriction', 'BFRT']","['knee extension', 'SF-36 role physical, bodily pain and HAQ scores', 'Quadriceps CSA', 'muscle strength, mass, function and health-related quality of life', 'partial blood flow restriction', 'maximal dynamic strength', 'TUG', 'lower-limb 1RM, quadriceps cross-sectional area (CSA), physical function (timed-stands test [TST], timed-up-and-go test [TUG], Health Assessment Questionnaire [HAQ]) and quality of life (Short Form Health Survey [SF-36', 'TST']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0102923', 'cui_str': 'HAQ'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",48.0,0.0203149,"SF-36 role physical, bodily pain and HAQ scores were improved only in BFRT (+45.7%, +22.5% and -55.9%, respectively; all p<0.05).","[{'ForeName': 'Reynaldo', 'Initials': 'R', 'LastName': 'Rodrigues', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rodrigo B', 'Initials': 'RB', 'LastName': 'Ferraz', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ceci O', 'Initials': 'CO', 'LastName': 'Kurimori', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lissiane K', 'Initials': 'LK', 'LastName': 'Guedes', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fernanda R', 'Initials': 'FR', 'LastName': 'Lima', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ana L', 'Initials': 'AL', 'LastName': 'de Sá-Pinto', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gualano', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Hamilton', 'Initials': 'H', 'LastName': 'Roschel', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}]",Arthritis care & research,['10.1002/acr.23911']
1145,32410715,Effects of multidomain versus single-domain training on executive control and memory in older adults: study protocol for a randomized controlled trial.,"BACKGROUND


Previous research suggests that both cognitive training and physical exercise help to maintain brain health and cognitive functions that decline with age. Some studies indicate that combined interventions may produce larger effects than each intervention alone. The aim of this study is to investigate the effects of combined cognitive and physical training compared to cognitive training and physical training alone on executive control and memory functions in healthy older adults.
OBJECTIVES


The main objectives of this four-arm randomized controlled trial (RCT) are: to investigate the synergetic effects of a simultaneous, group-based multidomain training program that combines cognitive video-game training with physical exercise, in comparison to those produced by cognitive training combined with physical control activity, physical training combined with cognitive control activity, or a combination of both control activities; to investigate whether event-related potential latencies of the P2 component are shorter and N2 and P3b components assessed in a memory-based task switching task are enhanced after training; and to find out whether possible enhancements persist after a 3-month period without training.
METHODS


In this randomized, single-blind, controlled trial, 144 participants will be randomly assigned to one of the four combinations of cognitive training and physical exercise. The cognitive component will be either video-game training (cognitive intervention, CI) or video games not specifically designed to train cognition (cognitive control, CC). The physical exercise component will either emphasize endurance, strength, and music-movement coordination (exercise intervention, EI) or stretching, toning, and relaxation (exercise control, EC).
DISCUSSION


This RCT will investigate the short and long-term effects of multidomain training, compared to cognitive training and physical training alone, on executive control and memory functions in healthy older adults, in comparison with the performance of an active control group.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03823183. Registered on 21 January 2019.",2020,"This RCT will investigate the short and long-term effects of multidomain training, compared to cognitive training and physical training alone, on executive control and memory functions in healthy older adults, in comparison with the performance of an active control group.
","['healthy older adults', '144 participants', 'older adults']","['cognitive training and physical exercise', 'video-game training (cognitive intervention, CI) or video games not specifically designed to train cognition (cognitive control, CC', 'multidomain versus single-domain training', 'cognitive training and physical training alone', 'combined cognitive and physical training', 'multidomain training', 'physical exercise component will either emphasize endurance, strength, and music-movement coordination (exercise intervention, EI) or stretching, toning, and relaxation (exercise control, EC', 'cognitive training combined with physical control activity, physical training combined with cognitive control activity, or a combination of both control activities']","['executive control and memory functions', 'executive control and memory']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4760627', 'cui_str': '144'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",144.0,0.0322726,"This RCT will investigate the short and long-term effects of multidomain training, compared to cognitive training and physical training alone, on executive control and memory functions in healthy older adults, in comparison with the performance of an active control group.
","[{'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Ballesteros', 'Affiliation': 'Studies on Aging and Neurodegenerative Diseases Research Group, Universidad Nacional de Educación a Distancia, Madrid, Spain. mballesteros@psi.uned.es.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Rieker', 'Affiliation': 'Studies on Aging and Neurodegenerative Diseases Research Group, Universidad Nacional de Educación a Distancia, Madrid, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Mayas', 'Affiliation': 'Studies on Aging and Neurodegenerative Diseases Research Group, Universidad Nacional de Educación a Distancia, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Prieto', 'Affiliation': 'Studies on Aging and Neurodegenerative Diseases Research Group, Universidad Nacional de Educación a Distancia, Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Toril', 'Affiliation': 'Studies on Aging and Neurodegenerative Diseases Research Group, Universidad Nacional de Educación a Distancia, Madrid, Spain.'}, {'ForeName': 'María Pilar', 'Initials': 'MP', 'LastName': 'Jiménez', 'Affiliation': 'Studies on Aging and Neurodegenerative Diseases Research Group, Universidad Nacional de Educación a Distancia, Madrid, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Reales', 'Affiliation': 'Studies on Aging and Neurodegenerative Diseases Research Group, Universidad Nacional de Educación a Distancia, Madrid, Spain.'}]",Trials,['10.1186/s13063-020-04293-3']
1146,31436494,Evaluating the Acceptability and Feasibility of Providing Egg or Cereal Breakfast during a Family-Based Treatment for Children with Overweight/Obesity: The Families and Breakfast Pilot Trial.,"Background:  Family-based behavioral treatment (FBT) is the most successful weight-loss treatment for children with overweight and obesity, however, long-term success is only achieved by a third of children over time. The use of foods that induce satiety, such as eggs, could improve adherence to calorically restricted diets in children and improve outcomes. This study explored the consumption of eggs (FBT+egg) or cereal (FBT+cereal) for breakfast as part of an FBT program, when breakfast foods were provided to families.  Methods:  Fifty 8-12-year-old children with overweight and obesity and their parents were randomized to a 4-month FBT+egg or FBT+cereal treatment program. Families were provided the ingredients for their assigned breakfast at each treatment session, and instructed to consume the breakfast a minimum of 5 days per week. Families attended assessments at baseline, post-treatment, and 4-months post-treatment.  Results:  Results showed that both treatments were well liked, FBT attendance was similar, and there was high compliance with consumption of the specified breakfast. Children experienced moderate weight loss at post-treatment [-0.11 standardized BMI (BMIz)] through 4-month follow-up (-0.09 BMIz), with no statistically significant differences (mean difference -0.05 BMIz, 95% confidence interval -0.19 to 0.09) observed between egg and cereal conditions across any anthropometric or appetitive measures.  Conclusions:  The use of eggs for breakfast in children enrolled in FBT was well tolerated, and future studies should include larger samples and longer follow-up periods to assess the potential differential effects of prescribed breakfasts on children's weight and eating behaviors.",2019,"The use of foods that induce satiety, such as eggs, could improve adherence to calorically restricted diets in children and improve outcomes.","['children enrolled in', 'children with overweight and obesity', 'Fifty 8-12-year-old children with overweight and obesity and their parents', 'Children with Overweight/Obesity']","[':  Family-based behavioral treatment (FBT', 'FBT', 'Providing Egg or Cereal Breakfast', 'FBT+egg or FBT+cereal treatment program']","['moderate weight loss', 'well liked, FBT attendance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0007757', 'cui_str': 'Cereal Grain'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0596794,"The use of foods that induce satiety, such as eggs, could improve adherence to calorically restricted diets in children and improve outcomes.","[{'ForeName': 'Kerri N', 'Initials': 'KN', 'LastName': 'Boutelle', 'Affiliation': 'Department of Pediatrics, University of California, San Diego, La Jolla, CA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Manzano', 'Affiliation': 'Department of Pediatrics, University of California, San Diego, La Jolla, CA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Strong', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, CA.'}, {'ForeName': 'Kyung E', 'Initials': 'KE', 'LastName': 'Rhee', 'Affiliation': 'Department of Pediatrics, University of California, San Diego, La Jolla, CA.'}]",Childhood obesity (Print),['10.1089/chi.2018.0331']
1147,32410722,"Targeted outdoor residual spraying, autodissemination devices and their combination against  Aedes  mosquitoes: field implementation in a Malaysian urban setting.","Currently, dengue control relies largely on reactive vector control programmes. Proactive vector-control using a rational, well-balanced integrated vector management approach may prove more successful for dengue control. As part of the development of a cluster randomized controlled epidemiological trial, a study was conducted in Johor Bahru, Malaysia. The study included one control site (three buildings) and three intervention sites which were treated as follows: targeted outdoor residual spraying only (TORS site, two buildings); deployment of autodissemination devices only (ADD site, four buildings); and the previous two treatments combined (TORS + ADD site, three buildings). The primary entomological measurement was per cent of positive ovitraps-ovitrap index (OI). The effect of each intervention on OI was analyzed by a modified ordinary least squares regression model. Relative to the control site, the TORS and ADD sites showed a reduction in the Aedes OI (-6.5%, P = 0.04 and -8.3%, P = 0.10, respectively). Analysis by species showed that, relative to control, the Ae. aegypti OI was lower in ADD (-8.9%, P = 0.03) and in TORS (-10.4%, P = 0.02). No such effect was evident in the TORS + ADD site. The present study provides insights into the methods to be used for the main trial. The combination of multiple insecticides with different modes of action in one package is innovative, although we could not demonstrate the additive effect of TORS + ADD. Further work is required to strengthen our understanding of how these interventions impact dengue vector populations and dengue transmission.",2020,"aegypti OI was lower in ADD (-8.9%, P = 0.03) and in TORS (-10.4%, P = 0.02).",['Malaysian urban setting'],"['outdoor residual spraying only (TORS site, two buildings); deployment of autodissemination devices only (ADD site, four buildings); and the previous two treatments combined (TORS + ADD site, three buildings', 'Targeted outdoor residual spraying, autodissemination devices and their combination against']","['per cent of positive ovitraps-ovitrap index (OI', 'TORS', 'aegypti OI']","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0521124', 'cui_str': 'Against'}]","[{'cui': 'C0562018', 'cui_str': 'cent'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0233349,"aegypti OI was lower in ADD (-8.9%, P = 0.03) and in TORS (-10.4%, P = 0.02).","[{'ForeName': 'Nurulhusna Ab', 'Initials': 'NA', 'LastName': 'Hamid', 'Affiliation': 'Medical Entomology Unit, Institute for Medical Research, WHO Collaborating Centre, Institute for Medical Research, Ministry of Health Malaysia, Jalan Pahang, 50588Kuala Lumpur, Malaysia.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Alexander', 'Affiliation': 'MRC Tropical Epidemiology Group, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, Keppel St, London, WC1E 7HT, United Kingdom.'}, {'ForeName': 'Remco', 'Initials': 'R', 'LastName': 'Suer', 'Affiliation': 'In2Care B.V., Marijkeweg 22, 6871SE Wageningen, the Netherlands.'}, {'ForeName': 'Nazni Wasi', 'Initials': 'NW', 'LastName': 'Ahmed', 'Affiliation': 'Medical Entomology Unit, Institute for Medical Research, WHO Collaborating Centre, Institute for Medical Research, Ministry of Health Malaysia, Jalan Pahang, 50588Kuala Lumpur, Malaysia.'}, {'ForeName': 'Rose Nani', 'Initials': 'RN', 'LastName': 'Mudin', 'Affiliation': 'Vector Borne Disease Sector, Disease Control Division, Federal Government Administrative Center, Ministry of Health Malaysia, Level 4, Block E10, Complex E, 62590Putrajaya, Malaysia.'}, {'ForeName': 'Topek', 'Initials': 'T', 'LastName': 'Omar', 'Affiliation': 'Vector Borne Disease Sector, Disease Control Division, Federal Government Administrative Center, Ministry of Health Malaysia, Level 4, Block E10, Complex E, 62590Putrajaya, Malaysia.'}, {'ForeName': 'Rahmat', 'Initials': 'R', 'LastName': 'Dapari', 'Affiliation': 'Vector Borne Disease Sector, Disease Control Division, Federal Government Administrative Center, Ministry of Health Malaysia, Level 4, Block E10, Complex E, 62590Putrajaya, Malaysia.'}, {'ForeName': 'Shahrom Nor Azian', 'Initials': 'SNA', 'LastName': 'Che Mat Din', 'Affiliation': 'Public Health Division, Johor, Johor State Health Department, Ministry of Health Malaysia, Jalan Persiaran Permai, 81200Johor Bahru Johor, Malaysia.'}, {'ForeName': 'Roslinda Abdul', 'Initials': 'RA', 'LastName': 'Rahman', 'Affiliation': 'Public Health Division, Johor, Johor State Health Department, Ministry of Health Malaysia, Jalan Persiaran Permai, 81200Johor Bahru Johor, Malaysia.'}, {'ForeName': 'Ropiah', 'Initials': 'R', 'LastName': 'Jaraee', 'Affiliation': 'Entomology and Pest Unit Public Health Division, Johor, Johor State Health Department, Ministry of Health Malaysia, Jalan Persiaran Permai, 81200Johor Bahru Johor, Malaysia.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Baur', 'Affiliation': 'Bayer S.A.S, Environmental Science, Crop Science Division, 16 rue Jean Marie Leclair; 69266 Lyon Cedex 09, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Schmitt', 'Affiliation': 'Bayer S.A.S, Environmental Science, Crop Science Division, 16 rue Jean Marie Leclair; 69266 Lyon Cedex 09, France.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Hamon', 'Affiliation': 'Innovative Vector Control Consortium, Pembroke Place, L3 5QA, Liverpool, UK.'}, {'ForeName': 'Jason H', 'Initials': 'JH', 'LastName': 'Richardson', 'Affiliation': 'Innovative Vector Control Consortium, Pembroke Place, L3 5QA, Liverpool, UK.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Langlois-Jacques', 'Affiliation': 'Hospices Civils de Lyon, Service de Biostatistique et Bioinformatique, F-69003 Lyon, France; Université de Lyon, F-69000 Lyon, France; Université Lyon 1, F-69100 Villeurbanne, France; CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, F-69100Villeurbanne, France.'}, {'ForeName': 'Rabilloud', 'Initials': 'R', 'LastName': 'Muriel', 'Affiliation': 'Hospices Civils de Lyon, Service de Biostatistique et Bioinformatique, F-69003 Lyon, France; Université de Lyon, F-69000 Lyon, France; Université Lyon 1, F-69100 Villeurbanne, France; CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, F-69100Villeurbanne, France.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Saadatian-Elahi', 'Affiliation': ""Service d'Hygiène, Epidémiologie et Prévention, Hospices Civils de Lyon, F-69437Lyon, France and Laboratoire des Pathogènes Emergents - Fondation Mérieux, Centre International de Recherche en Infectiologie, Institut National de la Santé et de la Recherche Médicale U1111, Centre National de la Recherche Scientifique, UMR5308, Ecole Normale Supérieure de Lyon, Université Claude Bernard Lyon 1, 21, Avenue Tony Garnier, 69007Lyon, France.""}]",Bulletin of entomological research,['10.1017/S0007485320000188']
1148,31562889,Clinical and OCT outcomes of a universal adhesive in a randomized clinical trial after 12 months.,"OBJECTIVES


To assess the performance of a universal adhesive in different application modes in non-carious cervical lesions clinically and by optical coherence tomography (OCT).
METHODS


55 adult patients with three non-carious cervical lesions (NCCL) each participated in the study. Lesions were restored with Scotchbond™ Universal (SBU, 3 M) applied in the self-etch (SBU-SE) and the selective-enamel-etch mode (SBU-SEE) in combination with Filtek™ Supreme XTE (3 M). OptiBond™ FL (OFL, Kerr) was used as a control. Restorations were clinically assessed (FDI criteria) after 14 days, 6 and 12 months and in parallel imaged by OCT (interfacial adhesive defects), starting immediately after filling placement. Cumulative failure rates (CFR) and means of interfacial adhesive defect were statistically evaluated.
RESULTS


After 12 months, CFRs were lower in the SBU groups (0.0% each) than in the OFL group (20.0%, p = 0.001). Clinically, small marginal fractures occurred three times more often in the SBU-SE than in the SBU-SEE group (p = 0.001). Immediately after filling placement and at each reassessment OCT revealed more interfacial defects at enamel interfaces for SBU/SE compared to SBU/SEE and OFL (p i  ≤ 0.044). At dentin/cement more defects were seen with OFL compared to SBU/SE and SBU/SEE (p i  ≤ 0.001). Before restoration loss, more interfacial defects appeared compared to remaining restorations (p immediately/6M  = 0.132/0.002).
CONCLUSIONS


Clinical evaluation and OCT imaging revealed higher interfacial integrity for SBU in both application modes compared to OFL. OCT detected interfacial bond failures prior to clinical deterioration or restoration loss.
CLINICAL SIGNIFICANCE


Scotchbond Universal showed an equivalent or improved bonding performance compared to the reference adhesive. Selective enamel etching is recommended. The parameter interfacial adhesive defect seems to be a valuable predictor for evaluation of adhesive restoration systems.",2019,Immediately after filling placement and at each reassessment OCT revealed more interfacial defects at enamel interfaces for SBU/SE compared to SBU/SEE and OFL (p i  ≤ 0.044).,['55 adult patients with three non-carious cervical lesions (NCCL) each participated in the study'],['OFL'],"['bonding performance', 'interfacial defects', 'CFRs', 'small marginal fractures', 'OptiBond TM  FL (OFL, Kerr', 'Cumulative failure rates (CFR) and means of interfacial adhesive defect']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4274086', 'cui_str': 'Non carious lesion at cervical margin of tooth (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0296330', 'cui_str': 'Optibond'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}]",55.0,0.0371188,Immediately after filling placement and at each reassessment OCT revealed more interfacial defects at enamel interfaces for SBU/SE compared to SBU/SEE and OFL (p i  ≤ 0.044).,"[{'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Haak', 'Affiliation': 'Department of Cariology, Endodontology and Periodontology, University of Leipzig, Liebigstraße 12, 04103 Leipzig, Germany. Electronic address: rainer.haak@medizin.uni-leipzig.de.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Hähnel', 'Affiliation': 'Department of Cariology, Endodontology and Periodontology, University of Leipzig, Liebigstraße 12, 04103 Leipzig, Germany. Electronic address: marcus.haehnel@medizin.uni-leipzig.de.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Schneider', 'Affiliation': 'Department of Cariology, Endodontology and Periodontology, University of Leipzig, Liebigstraße 12, 04103 Leipzig, Germany. Electronic address: hartmut.schneider@medizin.uni-leipzig.de.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Rosolowski', 'Affiliation': 'Institute for Medical Informatics, Statistics and Epidemiology (IMISE), Härtelstraße 16-18, 04107 Leipzig, University of Leipzig, Germany. Electronic address: maciej.rosolowski@medizin.uni-leipzig.de.'}, {'ForeName': 'Kyung-Jin', 'Initials': 'KJ', 'LastName': 'Park', 'Affiliation': 'Department of Cariology, Endodontology and Periodontology, University of Leipzig, Liebigstraße 12, 04103 Leipzig, Germany. Electronic address: kyung-jin.park@medizin.uni-leipzig.de.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Ziebolz', 'Affiliation': 'Department of Cariology, Endodontology and Periodontology, University of Leipzig, Liebigstraße 12, 04103 Leipzig, Germany. Electronic address: dirk.ziebolz@medizin.uni-leipzig.de.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Häfer', 'Affiliation': 'Department of Cariology, Endodontology and Periodontology, University of Leipzig, Liebigstraße 12, 04103 Leipzig, Germany. Electronic address: matthias.haefer@medizin.uni-leipzig.de.'}]",Journal of dentistry,['10.1016/j.jdent.2019.103200']
1149,31718499,Impact of a Design-Based Bike Exergame on Young Adults' Physical Activity Metrics and Situational Interest.,"Purpose : Despite the benefits of commercial exergames, in the practical application, players might not be spending sufficient time in physical activity levels compatible with health outcomes. We adopted a design-based exergame approach to build a bike exergame called Greedy Rabbit. The purpose of this study was to identify the impact of Greedy Rabbit on players' physical activity metrics and situational interest.  Method : Sixty undergraduate students were assigned to two groups: an experimental group playing Greedy Rabbit (N = 41) and a control group playing a placebo version of Greedy Rabbit (N = 19). The physical activity metrics measured were maximum oxygen consumption, heart rate and cadence.  Results : The experimental group reported higher scores for all physical activity metrics and for two dimensions of situational interest (instant enjoyment and attention demand). Furthermore, the physical activity metrics increased more during the exergame for the experimental group, reaching the standard guidelines for vigorous physical activity.  Conclusion : This study demonstrated that a design-based bike exergame might be a good option to enhance players' health-related physical activity outcomes and situational interest.",2020,The experimental group reported higher scores for all physical activity metrics and for two dimensions of situational interest (instant enjoyment and attention demand).,"['Sixty undergraduate students', 'Young Adults']","['Design-Based Bike Exergame', 'control group playing a placebo version of Greedy Rabbit', 'experimental group playing Greedy Rabbit']","['maximum oxygen consumption, heart rate and cadence', 'Physical Activity Metrics and Situational Interest', 'situational interest (instant enjoyment and attention demand', 'physical activity metrics']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C3887509', 'cui_str': 'Rabbits'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0246847,The experimental group reported higher scores for all physical activity metrics and for two dimensions of situational interest (instant enjoyment and attention demand).,"[{'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Roure', 'Affiliation': 'University of Teacher Education.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Pasco', 'Affiliation': 'University of Bourgogne Franche-Comté.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Benoît', 'Affiliation': 'Université Catholique de Louvain.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Deldicque', 'Affiliation': 'Université Catholique de Louvain.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2019.1665621']
1150,31665808,Laparoscopy for living donor left nephrectomy: Comparison of three-dimensional and two-dimensional vision.,"The main objective of this preliminary study was to evaluate the feasibility and safety of 3-D laparoscopic living donor left nephrectomy (LDLN). The secondary objective was to compare intraoperative and postoperative outcomes between 3-D and 2-D laparoscopic LDLN. All patients who underwent a laparoscopic LDLN from January 2015 to April 2018 in a university center were included. All surgeries were performed by three experienced surgeons. Seventy three patients were included the following: 16 underwent a 3-D laparoscopic LDLN (3-D group), and 57 underwent a 2-D laparoscopic LDLN (2-D group). Operative time and warm ischemia time (WIT) were significantly lower in the 3-D group (operative time: 80.9 ± 10.2 vs 114.1 ± 32.3 minutes in the 3-D and 2-D groups, P = .0002) (WIT: 1.7 ± 0.6 vs 2.3 ± 0.9 minutes in the 3-D and 2-D groups, P = .02). No conversion to open surgery occurred in both groups. Length of hospital stay was significantly shorter in the 3-D group. No major postoperative complications (Clavien ≥ III) occurred. One-year postoperative GFR was similar to 3-D and 2-D groups. Our preliminary study demonstrates that 3-D laparoscopic LDLN is a feasible and safe surgical procedure. Intraoperative and postoperative outcomes were similar in both 2-D and 3-D vision systems, but 3-D vision systems allow reduction in WIT and operative time.",2019,"Intraoperative and postoperative outcomes were similar in both 2-D and 3-D vision systems, but 3-D vision systems allow reduction in WIT and operative time.","['All patients who underwent a laparoscopic LDLN from January 2015 to April 2018 in a university center were included', '73 patients were included: 16 underwent a']","['3-D laparoscopic living donor left nephrectomy (LDLN', '3-D laparoscopic LDLN', '3-D laparoscopic LDLN (3-D group) and 57 underwent a 2-D laparoscopic LDLN', 'Laparoscopy for Living Donor']","['Length of hospital stay', 'Intraoperative and postoperative outcomes', 'major postoperative complications (Clavien ≥III', 'WIT and operative time', 'feasibility and safety', 'Operative time and warm ischemia time (WIT', 'GFR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C2222800', 'cui_str': 'Excision of left kidney'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0348050', 'cui_str': 'Living Donors'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0043197', 'cui_str': 'Wit as Topic'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1563923', 'cui_str': 'Warm Ischemic Time'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}]",73.0,0.0698087,"Intraoperative and postoperative outcomes were similar in both 2-D and 3-D vision systems, but 3-D vision systems allow reduction in WIT and operative time.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Prudhomme', 'Affiliation': 'Department of Urology, Kidney Transplantation and Andrology, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Roumiguié', 'Affiliation': 'Department of Urology, Kidney Transplantation and Andrology, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Thibaut', 'Initials': 'T', 'LastName': 'Benoit', 'Affiliation': 'Department of Urology, Kidney Transplantation and Andrology, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Lesourd', 'Affiliation': 'Department of Urology, Kidney Transplantation and Andrology, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Jean Baptiste', 'Initials': 'JB', 'LastName': 'Beauval', 'Affiliation': 'Department of Urology, Clinique La Croix du Sud, Toulouse, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Doumerc', 'Affiliation': 'Department of Urology, Kidney Transplantation and Andrology, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Sallusto', 'Affiliation': 'Department of Urology, Kidney Transplantation and Andrology, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Soulié', 'Affiliation': 'Department of Urology, Kidney Transplantation and Andrology, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Kamar', 'Affiliation': 'Department of Nephrology and Organ Transplantation, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Gamé', 'Affiliation': 'Department of Urology, Kidney Transplantation and Andrology, Toulouse University Hospital, Toulouse, France.'}]",Clinical transplantation,['10.1111/ctr.13745']
1151,31370912,"Trajectories and Predictors of Children's Early-Starting Conduct Problems: Child, Family, Genetic, and Intervention Effects.","Several research teams have previously traced patterns of emerging conduct problems (CP) from early or middle childhood. The current study expands on this previous literature by using a genetically-informed, experimental, and long-term longitudinal design to examine trajectories of early-emerging conduct problems and early childhood discriminators of such patterns from the toddler period to adolescence. The sample represents a cohort of 731 toddlers and diverse families recruited based on socioeconomic, child, and family risk, varying in urbanicity and assessed on nine occasions between ages 2 and 14. In addition to examining child, family, and community level discriminators of patterns of emerging conduct problems, we were able to account for genetic susceptibility using polygenic scores and the study's experimental design to determine whether random assignment to the Family Check-Up (FCU) discriminated trajectory groups. In addition, in accord with differential susceptibility theory, we tested whether the effects of the FCU were stronger for those children with higher genetic susceptibility. Results augmented previous findings documenting the influence of child (inhibitory control [IC], gender) and family (harsh parenting, parental depression, and educational attainment) risk. In addition, children in the FCU were overrepresented in the persistent low versus persistent high CP group, but such direct effects were qualified by an interaction between the intervention and genetic susceptibility that was consistent with differential susceptibility. Implications are discussed for early identification and specifically, prevention efforts addressing early child and family risk.",2019,"In addition, children in the FCU were overrepresented in the persistent low versus persistent high CP group, but such direct effects were qualified by an interaction between the intervention and genetic susceptibility that was consistent with differential susceptibility.","['731 toddlers and diverse families recruited based on socioeconomic, child, and family risk, varying in urbanicity and assessed on nine occasions between ages 2 and 14']",[],"['child (inhibitory control [IC], gender) and family (harsh parenting, parental depression, and educational attainment) risk']","[{'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",731.0,0.0284405,"In addition, children in the FCU were overrepresented in the persistent low versus persistent high CP group, but such direct effects were qualified by an interaction between the intervention and genetic susceptibility that was consistent with differential susceptibility.","[{'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Shaw', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Chardée A', 'Initials': 'CA', 'LastName': 'Galán', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Lemery-Chalfant', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Dishion', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Kit K', 'Initials': 'KK', 'LastName': 'Elam', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Melvin N', 'Initials': 'MN', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychology, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Gardner', 'Affiliation': 'Department of Social Policy & Intervention, University of Oxford, Oxford, UK.'}]",Development and psychopathology,['10.1017/S0954579419000828']
1152,30965213,Prophylactic antibiotics reduce hospitalisations and cost in locally advanced head and neck cancer patients treated with chemoradiotherapy: A randomised phase 2 study.,"BACKGROUND


Platinum-based chemoradiotherapy for locally advanced head and neck cancer (LAHNC) induces a high rate of acute toxicity, including dysphagia and aspiration pneumonia. We hypothesised that prophylactic antibiotics can prevent pneumonia and hospitalisations and can be cost-effective.
PATIENT AND METHODS


In this multicentre randomised trial, patients with LAHNC treated with chemoradiotherapy received prophylactic amoxicillin/clavulanic acid from day 29 after the start of treatment until 14 days after completion of chemoradiotherapy or standard care without prophylaxis. The primary objective was to observe a reduction in pneumonias. Secondary objectives were to evaluate the hospitalisation rate, adverse events, costs and health-related quality of life.
RESULTS


One hundred six patients were included; of which, 95 were randomised: 48 patients were allocated to the standard group and 47 patients to the prophylaxis group. A pneumonia during chemoradiotherapy and follow-up until 3.5 months was observed in 22 (45.8%) of 48 patients in the standard group and in 22 (46.8%) of 47 patients in the prophylaxis group (p = 0.54). Hospitalisation rate was significantly higher in the standard group versus the prophylaxis group, 19 of 48 pts (39.6%) versus 9 of 47 pts (19.1%), respectively (p = 0.03). Significantly more episodes with fever of any grade were observed in the standard group (29.2% vs 10.2%, p = 0.028). A significant difference in costs was found, with an average reduction of €1425 per patient in favour of the prophylaxis group.
CONCLUSION


Although prophylactic antibiotics during chemoradiotherapy for patients with LAHNC did not reduce the incidence of pneumonias, it did reduce hospitalisation rates and episodes with fever significantly and consequently tended to be cost-effective.",2019,"A significant difference in costs was found, with an average reduction of €1425 per patient in favour of the prophylaxis group.
","['One hundred six patients were included; of which, 95 were randomised: 48 patients were allocated to the standard group and 47 patients to the prophylaxis group', 'locally advanced head and neck cancer patients treated with', 'patients with LAHNC treated with', 'locally advanced head and neck cancer (LAHNC']","['prophylactic antibiotics', 'Platinum-based chemoradiotherapy', 'chemoradiotherapy or standard care without prophylaxis', 'chemoradiotherapy received prophylactic amoxicillin/clavulanic acid', 'chemoradiotherapy', 'Prophylactic antibiotics']","['hospitalisation rate, adverse events, costs and health-related quality of life', 'pneumonias', 'Hospitalisation rate', 'episodes with fever of any grade', 'costs', 'hospitalisation rates and episodes with fever']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0055860', 'cui_str': 'Clavulanic Acid'}]","[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",106.0,0.12302,"A significant difference in costs was found, with an average reduction of €1425 per patient in favour of the prophylaxis group.
","[{'ForeName': 'Janneke C', 'Initials': 'JC', 'LastName': 'Ham', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Postbox 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Chantal M', 'Initials': 'CM', 'LastName': 'Driessen', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Postbox 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Mathijs P', 'Initials': 'MP', 'LastName': 'Hendriks', 'Affiliation': 'Department of Internal Medicine, Northwest Clinics, Alkmaar, The Netherlands.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Fiets', 'Affiliation': 'Department of Internal Medicine, Medical Center Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Kreike', 'Affiliation': 'Department of Radiation Oncology, Radiotherapeutic Institute Arnhem, Arnhem, The Netherlands.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Hoeben', 'Affiliation': 'Department of Medical Oncology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Slingerland', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Claudia C', 'Initials': 'CC', 'LastName': 'van Opstal', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Postbox 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Bart Jan', 'Initials': 'BJ', 'LastName': 'Kullberg', 'Affiliation': 'Department of Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, Postbox 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Marianne A', 'Initials': 'MA', 'LastName': 'Jonker', 'Affiliation': 'Biostatistics, Radboud Institute for Health Sciences, Radboud University Medical Center, Postbox 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Eddy M', 'Initials': 'EM', 'LastName': 'Adang', 'Affiliation': 'Biostatistics, Radboud Institute for Health Sciences, Radboud University Medical Center, Postbox 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Johannes H', 'Initials': 'JH', 'LastName': 'Kaanders', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Postbox 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Winette T', 'Initials': 'WT', 'LastName': 'van der Graaf', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Postbox 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'van Herpen', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Postbox 9101, 6500 HB, Nijmegen, The Netherlands. Electronic address: Carla.vanHerpen@radboudumc.nl.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.02.013']
1153,31714986,Effect of Bempedoic Acid vs Placebo Added to Maximally Tolerated Statins on Low-Density Lipoprotein Cholesterol in Patients at High Risk for Cardiovascular Disease: The CLEAR Wisdom Randomized Clinical Trial.,"Importance


Additional treatment options are needed for patients who do not achieve sufficient reduction in low-density lipoprotein cholesterol (LDL-C) level with available lipid-lowering therapies.
Objective


To assess the efficacy of bempedoic acid vs placebo in patients at high cardiovascular risk receiving maximally tolerated lipid-lowering therapy.
Design, Setting, and Participants


Phase 3, randomized, double-blind, placebo-controlled clinical trial conducted at 91 clinical sites in North America and Europe from November 2016 to September 2018, with a final date of follow-up of September 22, 2018. A total of 779 patients with atherosclerotic cardiovascular disease, heterozygous familial hypercholesterolemia, or both met randomization criteria, which included LDL-C level 70 mg/dL (1.8 mmol/L) or greater while receiving maximally tolerated lipid-lowering therapy.
Interventions


Patients were randomized 2:1 to treatment with bempedoic acid (180 mg) (n = 522) or placebo (n = 257) once daily for 52 weeks.
Main Outcomes and Measures


The primary end point was percent change from baseline in LDL-C level at week 12. Secondary measures included changes in levels of lipids, lipoproteins, and biomarkers.
Results


Among 779 randomized patients (mean age, 64.3 years; 283 women [36.3%]), 740 (95.0%) completed the trial. At baseline, mean LDL-C level was 120.4 (SD, 37.9) mg/dL. Bempedoic acid lowered LDL-C levels significantly more than placebo at week 12 (-15.1% vs 2.4%, respectively; difference, -17.4% [95% CI, -21.0% to -13.9%]; P < .001). Significant reductions with bempedoic acid vs placebo were observed at week 12 for non-high-density lipoprotein cholesterol (-10.8% vs 2.3%; difference, -13.0% [95% CI, -16.3% to -9.8%]; P < .001), total cholesterol (-9.9% vs 1.3%; difference, -11.2% [95% CI, -13.6% to -8.8%]; P < .001), apolipoprotein B (-9.3% vs 3.7%; difference, -13.0% [95% CI, -16.1% to -9.9%]; P < .001), and high-sensitivity C-reactive protein (median, -18.7% vs -9.4%; difference, -8.7% [asymptotic confidence limits, -17.2% to -0.4%]; P = .04). Common adverse events included nasopharyngitis (5.2% vs 5.1% with bempedoic acid and placebo, respectively), urinary tract infection (5.0% vs 1.9%), and hyperuricemia (4.2% vs 1.9%).
Conclusions and Relevance


Among patients at high risk for cardiovascular disease receiving maximally tolerated statins, the addition of bempedoic acid compared with placebo resulted in a significant lowering of LDL-C level over 12 weeks. Further research is needed to assess the durability and clinical effect as well as long-term safety.
Trial Registration


ClinicalTrials.gov Identifier: NCT02991118.",2019,"Significant reductions with bempedoic acid vs placebo were observed at week 12 for non-high-density lipoprotein cholesterol (-10.8% vs 2.3%; difference, -13.0% [95% CI, -16.3% to -9.8%]; P < .001), total cholesterol (-9.9% vs 1.3%; difference, -11.2% [95% CI, -13.6% to -8.8%]; P < .001), apolipoprotein B (-9.3% vs 3.7%; difference, -13.0% [95% CI, -16.1% to -9.9%]; P < .001), and high-sensitivity C-reactive protein (median, -18.7% vs -9.4%; difference, -8.7% [asymptotic confidence limits, -17.2% to -0.4%]; P = .04).","['Patients at High Risk for Cardiovascular Disease', '779 patients with atherosclerotic cardiovascular disease, heterozygous familial hypercholesterolemia, or both met randomization criteria, which included LDL-C level 70 mg/dL (1.8 mmol/L) or greater while receiving maximally tolerated lipid-lowering therapy', '779 randomized patients (mean age, 64.3 years; 283 women [36.3%]), 740 (95.0%) completed the trial', 'patients at high risk for cardiovascular disease receiving maximally tolerated statins', 'patients at high cardiovascular risk receiving maximally tolerated lipid-lowering therapy', 'controlled clinical trial conducted at 91 clinical sites in North America and Europe from November 2016 to September 2018, with a final date of follow-up of September 22, 2018']","['placebo', 'Bempedoic Acid vs Placebo', 'bempedoic acid vs placebo', 'bempedoic acid']","['high-sensitivity C-reactive protein', 'urinary tract infection', 'hyperuricemia', 'apolipoprotein B', 'changes in levels of lipids, lipoproteins, and biomarkers', 'Low-Density Lipoprotein Cholesterol', 'low-density lipoprotein cholesterol (LDL-C) level', 'LDL-C level', 'total cholesterol', 'density lipoprotein cholesterol', 'mean LDL-C level', 'nasopharyngitis', 'LDL-C levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0342882', 'cui_str': 'Familial hypercholesterolemia - heterozygous (disorder)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4708786', 'cui_str': 'Two hundred and eighty-three'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0936233', 'cui_str': 'Controlled Clinical Trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3659310', 'cui_str': '8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}]",779.0,0.807018,"Significant reductions with bempedoic acid vs placebo were observed at week 12 for non-high-density lipoprotein cholesterol (-10.8% vs 2.3%; difference, -13.0% [95% CI, -16.3% to -9.8%]; P < .001), total cholesterol (-9.9% vs 1.3%; difference, -11.2% [95% CI, -13.6% to -8.8%]; P < .001), apolipoprotein B (-9.3% vs 3.7%; difference, -13.0% [95% CI, -16.1% to -9.9%]; P < .001), and high-sensitivity C-reactive protein (median, -18.7% vs -9.4%; difference, -8.7% [asymptotic confidence limits, -17.2% to -0.4%]; P = .04).","[{'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Goldberg', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Erik S G', 'Initials': 'ESG', 'LastName': 'Stroes', 'Affiliation': 'Department of Vascular Medicine, Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Seth J', 'Initials': 'SJ', 'LastName': 'Baum', 'Affiliation': 'Preventive Cardiology Inc, Boca Raton, Florida.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Hanselman', 'Affiliation': 'Esperion Therapeutics Inc, Ann Arbor, Michigan.'}, {'ForeName': 'LeAnne T', 'Initials': 'LT', 'LastName': 'Bloedon', 'Affiliation': 'Esperion Therapeutics Inc, Ann Arbor, Michigan.'}, {'ForeName': 'Narendra D', 'Initials': 'ND', 'LastName': 'Lalwani', 'Affiliation': 'Esperion Therapeutics Inc, Ann Arbor, Michigan.'}, {'ForeName': 'Pragna M', 'Initials': 'PM', 'LastName': 'Patel', 'Affiliation': 'Esperion Therapeutics Inc, Ann Arbor, Michigan.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Esperion Therapeutics Inc, Ann Arbor, Michigan.'}, {'ForeName': 'P Barton', 'Initials': 'PB', 'LastName': 'Duell', 'Affiliation': 'Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health & Science University, Portland.'}]",JAMA,['10.1001/jama.2019.16585']
1154,31491379,Feasibility of a hospital outpatient day procedure for medication abortion at 13-18 weeks gestation: Findings from Nepal .,"OBJECTIVES


To evaluate the safety, acceptability and feasibility of a one-day outpatient medication abortion service at gestations 13-18 weeks.
STUDY DESIGN


Open-label prospective study in which participants received mifepristone 200 mg orally to swallow at home or at the clinic followed 24 h later by misoprostol 400 mcg buccally. They presented to the outpatient clinic 24-48 h after mifepristone for misoprostol 400 mcg buccally every three hours (no maximum dose). The primary outcome was successful abortion without transfer to overnight inpatient care. Secondary outcomes included time to abortion from initial misoprostol dose, safety, additional interventions and side effects.
RESULTS


We enrolled 230 women from December 2017 to November 2018. Approximately nine of ten (n = 206, 89.6%) achieved a successful abortion without transfer to overnight care. Twenty-four were transferred to overnight inpatient care; of these 18 were to manage a complication, five for incomplete abortion and two by choice. Among these 24, three women experienced an SAE. The median time to successful abortion from time of the first misoprostol dose was 7.2 h (range: 0.75-92.3), with an average of three misoprostol doses. Most participants expelled the fetus and the placenta at or around the same time; median time between fetal and placental expulsion was 15 minutes (range: 0-4.5 h). Fifteen participants (6.6%) received more than five misoprostol doses and were transferred to inpatient care. Administration of more than five doses of misoprostol was associated with nulliparity. Provision of antibiotics (27.9%, n = 64), manual removal of placenta (15.3%, n = 35), uterotonics (4.4%, n = 10) and surgical interventions (4.4%, n = 10) were also reported. About one in four participants experienced nausea, vomiting and chills; fever was infrequent (2.5%, n = 5).
CONCLUSIONS


For gestations 13-18 weeks, an outpatient day process for medication abortion is safe, effective and feasible.
IMPLICATIONS


Medication abortion in 13 - 18 weeks need not be limited to inpatient care; nine of ten cases can be managed as an outpatient day service.",2019,"Approximately nine of ten (n=206, 89.6%) achieved a successful abortion without transfer to overnight care.","['230 women from December 2017 to November 2018', 'Twenty-four were transferred to overnight inpatient care; of these 18 to manage a complication, five for incomplete abortion and two by choice', 'medication abortion at 13-18weeks gestation']","['mifepristone 200 mg orally to swallow', 'misoprostol', 'hospital outpatient day procedure', 'misoprostol 400 mcg buccally', 'mifepristone for misoprostol']","['time to abortion from initial misoprostol dose, safety, additional interventions and side effects', 'safe, effective and feasible', 'successful abortion without transfer to overnight care', 'median time to successful abortion', 'manual removal of placenta', 'successful abortion without transfer to overnight inpatient care', 'nausea, vomiting and chills; fever', 'safety, acceptability and feasibility']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0000810', 'cui_str': 'Abortion, Incomplete'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C1592637', 'cui_str': 'Mifepristone 200 MG [Mifeprex]'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0026088', 'cui_str': 'Mifepristone'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0195755', 'cui_str': 'Manual removal of retained placenta (procedure)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0085593', 'cui_str': 'Chills'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",230.0,0.147657,"Approximately nine of ten (n=206, 89.6%) achieved a successful abortion without transfer to overnight care.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Blum', 'Affiliation': 'Gynuity Health Projects, USA. Electronic address: jblum@gynuity.org.'}, {'ForeName': 'Chanda', 'Initials': 'C', 'LastName': 'Karki', 'Affiliation': 'Kathmandu Medical College, Nepal.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Tamang', 'Affiliation': 'CREHPA, Nepal.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Shochet', 'Affiliation': 'Gynuity Health Projects, USA.'}, {'ForeName': 'Achala', 'Initials': 'A', 'LastName': 'Shrestha', 'Affiliation': 'CREHPA, Nepal.'}, {'ForeName': 'Heera', 'Initials': 'H', 'LastName': 'Tuladhar', 'Affiliation': 'KIST Medical College, Teaching Hospital, Nepal.'}, {'ForeName': 'Aruna', 'Initials': 'A', 'LastName': 'Karki', 'Affiliation': 'Kathmandu Model Hospital, Nepal.'}, {'ForeName': 'Jyotsna', 'Initials': 'J', 'LastName': 'Sharma', 'Affiliation': 'Kathmandu Medical College, Nepal.'}, {'ForeName': 'Dina F', 'Initials': 'DF', 'LastName': 'Abbas', 'Affiliation': 'Gynuity Health Projects, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Dragoman', 'Affiliation': 'Gynuity Health Projects, USA.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Winikoff', 'Affiliation': 'Gynuity Health Projects, USA.'}]",Contraception,['10.1016/j.contraception.2019.08.007']
1155,31000477,"Safety and efficacy of VRC01 broadly neutralising antibodies in adults with acutely treated HIV (RV397): a phase 2, randomised, double-blind, placebo-controlled trial.","BACKGROUND


HIV-1-specific broadly neutralising antibodies such as VRC01 could promote HIV remission by halting viral replication and clearing infected cells. We investigated whether VRC01 could promote sustained viral control off antiretroviral therapy (ART) in adults who initiated ART during acute HIV infection.
METHODS


We did a randomised, double-blind, placebo-controlled trial at the Thai Red Cross AIDS Research Centre in Bangkok, Thailand. Eligible participants were aged 20-50 years, had initiated ART during acute infection (ie, Fiebig stages I-III), had been taking ART for more than 24 months, had fewer than 50 HIV-1 RNA copies per mL on three consecutive measurements, had more than 400 CD4 cells per μL, had fewer than ten copies of integrated HIV-1 DNA per 10 6  peripheral blood mononuclear cells, and were in generally good health. Eligible participants were randomly assigned (3:1) based on computer-generated lists with a blocking factor of 4 to receive VRC01 (40 mg/kg) or placebo (saline) intravenously every 3 weeks for up to 24 weeks during analytic interruption of ART, followed by continued observation off all therapies. Randomisation was stratified by Fiebig stage (I vs II vs III) at HIV diagnosis. Participants were monitored closely and resumed ART if 1000 or more HIV-1 RNA copies were detected per mL of plasma. The primary outcomes were the frequency of serious adverse events and the proportion of participants with fewer than 50 HIV-1 RNA copies per mL 24 weeks after treatment interruption. Efficacy analyses included all participants who received at least one full dose of study product, and safety analyses included all participants exposed to any study product. The trial was registered with ClinicalTrials.gov, number NCT02664415. This trial is completed.
FINDINGS


Between Aug 8, 2016, and Jan 9, 2017, 19 men were randomly assigned, 14 to the VRC01 group and five to the placebo group. One participant in the VRC01 group received a partial infusion without undergoing treatment interruption. The other 18 participants all received at least one full study infusion and underwent ART interruption. No serious adverse events were reported in either group. Only one participant in the VRC01 group achieved the primary efficacy endpoint of viral suppression 24 weeks after ART interruption. The other 17 restarted ART because of a confirmed recording of 1000 or more HIV-1 RNA copies per mL before 24 weeks.
INTERPRETATION


VRC01 monotherapy in individuals who initiated ART during acute HIV infection was well tolerated but did not significantly increase the number of participants with viral suppression 24 weeks after ART interruption. Further development of VRC01 and other immunotherapies for HIV will probably occur as part of combination regimens that include several treatments directed against unique therapeutic targets.
FUNDING


US Department of the Army, US National Institutes of Health, and the Thai Red Cross AIDS Research Centre.",2019,No serious adverse events were reported in either group.,"['adults who initiated ART during acute HIV infection', 'Thai Red Cross AIDS Research Centre in Bangkok, Thailand', 'adults with acutely treated HIV (RV397', 'Eligible participants were aged 20-50 years, had initiated ART during acute infection (ie, Fiebig stages I-III), had been taking ART for more than 24 months, had fewer than 50 HIV-1', 'participants who received at least one full dose of study product, and safety analyses included all participants exposed to any study product', 'Between Aug 8, 2016, and Jan 9, 2017, 19 men', 'Eligible participants', '18 participants all received at least one full study infusion and underwent ART interruption']","['VRC01', 'placebo', 'placebo (saline', 'computer-generated lists with a blocking factor of 4 to receive VRC01', 'partial infusion without undergoing treatment interruption', 'antiretroviral therapy (ART']","['serious adverse events', 'frequency of serious adverse events', 'Safety and efficacy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0343752', 'cui_str': 'Acute human immunodeficiency virus seroconversion illness'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0034907', 'cui_str': 'Red Crescent'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0275518', 'cui_str': 'Acute infectious disease (disorder)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0053851', 'cui_str': 'blocking factor'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",19.0,0.746782,No serious adverse events were reported in either group.,"[{'ForeName': 'Trevor A', 'Initials': 'TA', 'LastName': 'Crowell', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA. Electronic address: tcrowell@hivresearch.org.'}, {'ForeName': 'Donn J', 'Initials': 'DJ', 'LastName': 'Colby', 'Affiliation': 'SEARCH, the Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Suteeraporn', 'Initials': 'S', 'LastName': 'Pinyakorn', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Sacdalan', 'Affiliation': 'SEARCH, the Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Pagliuzza', 'Affiliation': 'Centre de Recherche du CHUM and Department of Microbiology, Infectiology and Immunology, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Jintana', 'Initials': 'J', 'LastName': 'Intasan', 'Affiliation': 'SEARCH, the Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Khunthalee', 'Initials': 'K', 'LastName': 'Benjapornpong', 'Affiliation': 'SEARCH, the Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Kamonkan', 'Initials': 'K', 'LastName': 'Tangnaree', 'Affiliation': 'SEARCH, the Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Nitiya', 'Initials': 'N', 'LastName': 'Chomchey', 'Affiliation': 'SEARCH, the Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Eugène', 'Initials': 'E', 'LastName': 'Kroon', 'Affiliation': 'SEARCH, the Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'de Souza', 'Affiliation': 'Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA; SEARCH, the Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Sodsai', 'Initials': 'S', 'LastName': 'Tovanabutra', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Morgane', 'Initials': 'M', 'LastName': 'Rolland', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Eller', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Paquin-Proulx', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Diane L', 'Initials': 'DL', 'LastName': 'Bolton', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Tokarev', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Rasmi', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Takata', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Lydie', 'Initials': 'L', 'LastName': 'Trautmann', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Shelly J', 'Initials': 'SJ', 'LastName': 'Krebs', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Kayvon', 'Initials': 'K', 'LastName': 'Modjarrad', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Adrian B', 'Initials': 'AB', 'LastName': 'McDermott', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Bailer', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Doria-Rose', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bijal', 'Initials': 'B', 'LastName': 'Patel', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gorelick', 'Affiliation': 'AIDS and Cancer Virus Program, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.'}, {'ForeName': 'Brandie A', 'Initials': 'BA', 'LastName': 'Fullmer', 'Affiliation': 'AIDS and Cancer Virus Program, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Schuetz', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA; Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Pornsuk V', 'Initials': 'PV', 'LastName': 'Grandin', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': ""O'Connell"", 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Ledgerwood', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Barney S', 'Initials': 'BS', 'LastName': 'Graham', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Tressler', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Mascola', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Chomont', 'Affiliation': 'Centre de Recherche du CHUM and Department of Microbiology, Infectiology and Immunology, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Nelson L', 'Initials': 'NL', 'LastName': 'Michael', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Merlin L', 'Initials': 'ML', 'LastName': 'Robb', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Nittaya', 'Initials': 'N', 'LastName': 'Phanuphak', 'Affiliation': 'SEARCH, the Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Jintanat', 'Initials': 'J', 'LastName': 'Ananworanich', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA; SEARCH, the Thai Red Cross AIDS Research Center, Bangkok, Thailand; Department of Global Health, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(19)30053-0']
1156,4590333,A comparative study of doxepin and placebo in depression.,,1973,,[],['doxepin and placebo'],[],[],"[{'cui': 'C0013085', 'cui_str': 'Doxepin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0185902,,"[{'ForeName': 'D V', 'Initials': 'DV', 'LastName': 'Jeste', 'Affiliation': ''}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Vahia', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ravindranath', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1157,31718393,Do Violence Acceptance and Bystander Actions Explain the Effects of Green Dot on Reducing Violence Perpetration in High Schools?,"This study extends prior analyses from a 5-year multisite cluster-randomized controlled trial to examine how the previously reported effects of the Green Dot bystander-based prevention program worked to reduce violence perpetration. Bystander-based interventions are hypothesized to prevent violence by reducing violence acceptance and increasing trained participants' willingness and ability to actively engage others in violence prevention using safe and effective bystander actions to diffuse or avoid potentially violent situations. We tested this hypothesis by examining whether Green Dot worked to reduce violence through two mediators measured over time: reducing violence acceptance and increasing bystander actions. When accounting for changes in these mediators over time, the effect of this intervention on violence perpetration was hypothesized to be attenuated or explained. At baseline (spring 2010) and annually (2011-2014), all students in recruited high schools (13 intervention, 13 control) completed an anonymous survey (response rate = 83.9%). Student responses were aggregated as school-level counts for the analysis. Path analyses estimated direct and indirect effects at specific points in the implementation of the intervention. Longitudinal models were used to determine if changes in violence acceptance and bystander actions could explain or attenuate the effect of the intervention. Time-framed path model analyses indicated that the intervention worked as expected to increase bystander behaviors and reduce violence acceptance; both potential mediators were significantly associated with sexual violence perpetration. In addition, after adjusting intent-to-treat models for the hypothesized mediators, the intervention was no longer associated with violence perpetration. In conclusion, these findings indicate that this bystander intervention worked as hypothesized to reduce sexual violence perpetration by creating theory-based changes in students' violence acceptance and bystander actions.",2019,Time-framed path model analyses indicated that the intervention worked as expected to increase bystander behaviors and reduce violence acceptance; both potential mediators were significantly associated with sexual violence perpetration.,"['At baseline (spring 2010) and annually (2011-2014), all students in recruited high schools (13 intervention, 13 control) completed an anonymous survey (response rate = 83.9']","['Green Dot bystander-based prevention program', 'Green Dot']","['sexual violence perpetration', 'bystander behaviors and reduce violence acceptance', 'violence acceptance and increasing bystander actions']","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}]",,0.0240952,Time-framed path model analyses indicated that the intervention worked as expected to increase bystander behaviors and reduce violence acceptance; both potential mediators were significantly associated with sexual violence perpetration.,"[{'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Bush', 'Affiliation': 'University of Kentucky, Lexington, USA.'}, {'ForeName': 'Ann L', 'Initials': 'AL', 'LastName': 'Coker', 'Affiliation': 'University of Kentucky, Lexington, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'DeGue', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Clear', 'Affiliation': 'University of Kentucky, Lexington, USA.'}, {'ForeName': 'Candace J', 'Initials': 'CJ', 'LastName': 'Brancato', 'Affiliation': 'University of Kentucky, Lexington, USA.'}, {'ForeName': 'Bonnie S', 'Initials': 'BS', 'LastName': 'Fisher', 'Affiliation': 'University of Cincinnati, OH, USA.'}]",Journal of interpersonal violence,['10.1177/0886260519888206']
1158,30981618,Efficacy of Non-ablative Laser Therapy for Lichen Sclerosus: A Randomized Controlled Trial.,"OBJECTIVE


The aim of this randomized controlled trial was to evaluate the safety and efficacy of neodymium: yttrium aluminum garnet laser treatment of lichen sclerosus (LS) by comparing it with topical corticosteroid treatment.
METHODS


A total of 40 female patients with vulvar LS were randomized 1:1 into a study (laser) group and a control (topical corticosteroids) group. The laser group received three laser treatments. Blinded evaluators evaluated biopsies and graded improvement on clinical photographs at baseline and at 3 months. Patients graded the intensity of symptoms on a 0 to 10 visual analogue scale at baseline and 1-, 3-, and 6-month follow-up. Patients also rated the tolerability of laser treatments, and side effects were monitored. (Canadian Task Force classification I) RESULTS: Laser treatment discomfort was on average 1.5 of 10 on the visual analogue scale. At 1- and 3-month follow-up, patients in the laser group had significantly greater improvement in LS symptoms (burning, itching, pain, and dyspareunia), better patient satisfaction, and greater reduction of sclerosis than patients in the topical corticosteroid group. At 6-month follow-up, the improvement of symptoms in the laser group was still significant. The correct order of photographs (before and after treatment) was assigned significantly more often in the laser-treated patients compared with the control group.
CONCLUSION


Laser therapy for LS caused minimal patient discomfort during the treatment, with no adverse effects, and demonstrated better efficacy than in the control group, with significant improvement lasting up to 6 months. Laser therapy is a promising option for patients not responding to topical corticosteroid therapy or patients wishing to reduce long-term corticosteroid maintenance use.",2019,"At 1- and 3-month follow-up, patients in the laser group had significantly greater improvement in LS symptoms (burning, itching, pain, and dyspareunia), better patient satisfaction, and greater reduction of sclerosis than patients in the topical corticosteroid group.","['patients not responding to topical corticosteroid therapy or patients wishing to reduce long-term corticosteroid maintenance use', 'Lichen Sclerosus', '40 female patients with vulvar LS']","['Non-ablative Laser Therapy', 'control (topical corticosteroids', 'Laser therapy', 'neodymium: yttrium aluminum garnet laser treatment']","['Laser treatment discomfort', 'safety and efficacy', 'minimal patient discomfort', 'tolerability of laser treatments, and side effects', 'LS symptoms (burning, itching, pain, and dyspareunia), better patient satisfaction', 'intensity of symptoms on a 0 to 10 visual analogue scale', 'improvement of symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0023652', 'cui_str': 'Lichen Sclerosus'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse (finding)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",40.0,0.0832864,"At 1- and 3-month follow-up, patients in the laser group had significantly greater improvement in LS symptoms (burning, itching, pain, and dyspareunia), better patient satisfaction, and greater reduction of sclerosis than patients in the topical corticosteroid group.","[{'ForeName': 'Urška', 'Initials': 'U', 'LastName': 'Bizjak Ogrinc', 'Affiliation': 'Gynecology Clinic Juna, Ljubljana, Slovenia. Electronic address: urska.bizjak-ogrinc@juna.si.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Senčar', 'Affiliation': 'Gynecology Clinic Juna, Ljubljana, Slovenia.'}, {'ForeName': 'Boštjan', 'Initials': 'B', 'LastName': 'Luzar', 'Affiliation': 'Institute of Pathology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Adolf', 'Initials': 'A', 'LastName': 'Lukanović', 'Affiliation': 'Department of Gynecology, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2019.01.023']
1159,30974479,Cognitive functional therapy in patients with non-specific chronic low back pain-a randomized controlled trial 3-year follow-up.,"OBJECTIVES


This randomized controlled trial investigated the efficacy of cognitive functional therapy (CFT) compared with manual therapy and exercise (MT-EX) for people with non-specific chronic low back pain (NSCLBP) at 3-year follow-up.
METHODS


Hundred and twenty-one patients were randomized to CFT (n = 62) or MT-EX (n = 59). Three-year data were available for 30 (48.4%) participants in the CFT group, and 33 (55.9%) participants in the MT-EX group. The primary outcomes were disability (Oswestry disability Index [ODI]) and pain intensity (numerical rating scale) and secondary outcomes were anxiety/depression (Hopkins Symptoms Checklist) and pain-related fear (Fear-Avoidance Belief Questionnaire). A full intention to treat analysis was conducted using linear mixed models.
RESULTS


Significantly greater reductions in disability were observed for the CFT group, with ODI scores at 3 years 6.6 points lower in the CFT than the MT-EX group (95%CI:-10.1 to -3.1, p < 0.001, standardized effect size = 0.70). There was no significant difference in pain intensity between the groups at 3 years (0.6 points 95%CI:-1.4-0.3, p = 0.195). Significantly greater reductions were also observed for the CFT group for Hopkins Symptoms Checklist and Fear-Avoidance Belief Questionnaire (Work).
CONCLUSIONS


CFT is more effective at reducing disability, depression/anxiety and pain-related fear, but not pain, at 3-year follow-up than MT-EX.
SIGNIFICANCE


Cognitive functional therapy (CFT) was more effective than manual therapy and exercise (MT-EX) in reducing disability at 3-year follow-up, in people with non-specific chronic low back pain. The sustained reduction in disability without concomitant reductions in pain intensity in the CFT group suggests a de-coupling of the pain-disability relationship. CFT resulted in long-lasting reductions in anxiety and depression, and pain-related fear regarding work compared to MT-EX. The findings support the long-term benefits of a individualized behaviourally orientated intervention that targets pain beliefs, functional restoration and lifestyle factors.",2019,"CFT resulted in long-lasting reductions in anxiety and depression, and pain-related fear regarding work compared to MT-EX.","['patients with non-specific chronic low back pain', 'people with non-specific chronic low back pain', 'Hundred and twenty-one patients', 'people with non-specific chronic low back pain (NSCLBP) at 3-year follow-up']","['CFT', 'cognitive functional therapy (CFT', 'manual therapy and exercise (MT-EX', 'Cognitive functional therapy (CFT', 'MT-EX', 'Cognitive functional therapy']","['anxiety and depression, and pain-related fear regarding work', 'disability (Oswestry disability Index [ODI]) and pain intensity (numerical rating scale) and secondary outcomes were anxiety/depression (Hopkins Symptoms Checklist) and pain-related fear (Fear-Avoidance Belief Questionnaire', 'pain beliefs, functional restoration and lifestyle factors', 'Hopkins Symptoms Checklist and Fear-Avoidance Belief Questionnaire (Work', 'pain intensity', 'disability, depression/anxiety and pain-related fear', 'disability', 'ODI scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0454525', 'cui_str': 'Manual Therapies'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",21.0,0.144855,"CFT resulted in long-lasting reductions in anxiety and depression, and pain-related fear regarding work compared to MT-EX.","[{'ForeName': 'Kjartan', 'Initials': 'K', 'LastName': 'Vibe Fersum', 'Affiliation': 'Physiotherapy Research Group, Department of Public Health and Primary Health Care, University of Bergen, Norway.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'School of Physiotherapy, Curtin University, Bentley, WA, Australia.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Kvåle', 'Affiliation': 'Research group Movement and Function, Western Norway University of Applied Science, Bergen, Norway.'}, {'ForeName': 'Jan Sture', 'Initials': 'JS', 'LastName': 'Skouen', 'Affiliation': 'Physiotherapy Research Group, Department of Public Health and Primary Health Care, University of Bergen, Norway.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""O'Sullivan"", 'Affiliation': 'School of Physiotherapy, Curtin University, Bentley, WA, Australia.'}]","European journal of pain (London, England)",['10.1002/ejp.1399']
1160,31000133,Effect of standard dose paracetamol versus placebo as antipyretic therapy on liver injury in adult dengue infection: a multicentre randomised controlled trial.,"BACKGROUND


Dengue is a common cause of acute liver failure in tropical countries. Paracetamol is the recommended antipyretic for dengue. Related observational studies in dengue have suggested that excessive paracetamol intake is related to hepatic injury. We aimed to evaluate whether standard dose paracetamol as an antipyretic in dengue infection caused transaminase elevation, and to evaluate the efficacy of paracetamol.
METHODS


In this randomised, double-blind, placebo-controlled trial, adult participants (aged ≥18 years) with dengue, as confirmed by either positive NS1 antigen, positive dengue IgM antigen with thrombocytopenia, or positive PCR test, were enrolled at three Royal Thai Army hospitals in Thailand. Key exclusion criteria were baseline AST or ALT concentrations of more than 3 times the upper limit of normal, cirrhosis, indication of paracetamol other than dengue infection, concurrent diagnosis of other causes of fever, or pregnancy. Patients were randomly assigned (1:1), by a computer-generated block randomisation procedure (block size of six), to receive either paracetamol (500 mg) or placebo (500 mg) every 4 h when body temperature exceeded 38°C during hospitalisation. Participants and investigators were masked to treatment assignment. The primary outcome was the proportion of participants with transaminase elevation, defined as serum aspartate transaminase (AST) and alanine transaminase (ALT) concentrations of more than 3 times the upper limit of normal on recovery day, in the intention-to-treat population. Prespecified interim analyses for safety and efficacy were performed with group sequential stopping boundaries. This trial is registered with ClinicalTrials.gov, number NCT02833584.
FINDINGS


Between Sept 1, 2016, and Dec 12, 2017, 125 participants were randomly assigned to receive either paracetamol (n=63) or placebo (n=62). 123 participants were included in the intention-to-treat population. The median daily dose of study medication was 1·5 g (IQR 0·8-2·0). The study was terminated early owing to a higher rate of transaminase elevation in the paracetamol group than in the placebo group (22% vs 10%; incidence rate ratio 3·77, 95% CI 1·36-10·46, p=0·011). The change of AST and ALT concentrations in the paracetamol group was higher than in the placebo group (mean difference 12·43 U/L per day, 7·16-17·71, p<0·0001 for AST; 7·40 U/L per day, 95% CI 3·68-11·13, p=0·0001 for ALT). Three participants in the paracetamol group had severe dengue: two had upper gastric haemorrhage and one had acute kidney injury. No patients died or had liver failure.
INTERPRETATION


Use of standard dose paracetamol in dengue infection increased the incidence of transaminase elevation, and also overall transaminase concentrations in the absence of a counterbalancing reduced fever or pain score.
FUNDING


Phramongkutklao College of Medicine.",2019,"The change of AST and ALT concentrations in the paracetamol group was higher than in the placebo group (mean difference 12·43 U/L per day, 7·16-17·71, p<0·0001 for AST; 7·40 U/L per day, 95% CI 3·68-11·13, p=0·0001 for ALT).","['Between Sept 1, 2016, and Dec 12, 2017, 125 participants', 'group had severe dengue: two had upper gastric haemorrhage and one had acute kidney injury', '123 participants were included in the intention-to-treat population', 'liver injury in adult dengue infection', 'adult participants (aged ≥18 years) with dengue, as confirmed by either positive NS1 antigen, positive dengue IgM antigen with thrombocytopenia, or positive PCR test, were enrolled at three Royal Thai Army hospitals in Thailand']","['Paracetamol', 'paracetamol', 'paracetamol (500 mg) or placebo', 'placebo']","['rate of transaminase elevation', 'proportion of participants with transaminase elevation, defined as serum aspartate transaminase (AST) and alanine transaminase (ALT) concentrations', 'safety and efficacy', 'change of AST and ALT concentrations', 'died or had liver failure']","[{'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0019100', 'cui_str': 'Philippine Hemorrhagic Fever'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0235325', 'cui_str': 'Gastric hemorrhage (disorder)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011311', 'cui_str': 'Break-Bone Fever'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0020861', 'cui_str': 'IgM'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0019997', 'cui_str': 'Hospitals, Army'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine Aminotransferase'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0085605', 'cui_str': 'Hepatic Failure'}]",123.0,0.787739,"The change of AST and ALT concentrations in the paracetamol group was higher than in the placebo group (mean difference 12·43 U/L per day, 7·16-17·71, p<0·0001 for AST; 7·40 U/L per day, 95% CI 3·68-11·13, p=0·0001 for ALT).","[{'ForeName': 'Vasin', 'Initials': 'V', 'LastName': 'Vasikasin', 'Affiliation': 'Division of Infectious Diseases, Phramongkutklao Hospital, Bangkok, Thailand. Electronic address: vvasin@gmail.com.'}, {'ForeName': 'Thanawith', 'Initials': 'T', 'LastName': 'Rojdumrongrattana', 'Affiliation': 'Department of Internal Medicine, Phramongkutklao Hospital, Bangkok, Thailand.'}, {'ForeName': 'Worayon', 'Initials': 'W', 'LastName': 'Chuerboonchai', 'Affiliation': 'Fort Adisorn Hospital, Saraburi, Thailand.'}, {'ForeName': 'Thanawhan', 'Initials': 'T', 'LastName': 'Siriwiwattana', 'Affiliation': 'Department of Internal Medicine, Phramongkutklao Hospital, Bangkok, Thailand.'}, {'ForeName': 'Wittaya', 'Initials': 'W', 'LastName': 'Thongtaeparak', 'Affiliation': 'Department of Internal Medicine, Phramongkutklao Hospital, Bangkok, Thailand.'}, {'ForeName': 'Suchada', 'Initials': 'S', 'LastName': 'Niyasom', 'Affiliation': 'Department of Internal Medicine, Ananda Mahidol Hospital, Lopburi, Thailand.'}, {'ForeName': 'Nawarat', 'Initials': 'N', 'LastName': 'Lertliewtrakool', 'Affiliation': 'Fort Adisorn Hospital, Saraburi, Thailand.'}, {'ForeName': 'Sitawee', 'Initials': 'S', 'LastName': 'Jitsiri', 'Affiliation': 'Fort Adisorn Hospital, Saraburi, Thailand.'}, {'ForeName': 'Dhitiwat', 'Initials': 'D', 'LastName': 'Changpradub', 'Affiliation': 'Division of Infectious Diseases, Phramongkutklao Hospital, Bangkok, Thailand.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30032-4']
1161,31719658,Effects of ventilatory strategy on arterial oxygenation and respiratory mechanics in overweight and obese patients undergoing posterior spine surgery.,"Prolonged inspiratory to expiratory (I:E) ratio ventilation may improve arterial oxygenation or gas exchange and respiratory mechanics in patients with obesity. We performed a randomised study to compare the effects of the conventional ratio ventilation (CRV) of 1:2 and the equal ratio ventilation (ERV) of 1:1 on arterial oxygenation and respiratory mechanics during spine surgery in overweight and obese patients. Fifty adult patients with a body mass index of ≥25 kg/m 2  were randomly allocated to receive an I:E ratio either l:2 (CRV; n = 25) or 1:1 (ERV; n = 25). Arterial oxygenation and respiratory mechanics were recorded in the supine position, and at 30 minutes and 90 minutes after placement in the prone position. The changes in partial arterial oxygen pressure (PaO 2 ) over time did not differ between the groups. The changes in partial arterial carbon dioxide pressure over time were significantly different between the two groups (P = 0.040). The changes in mean airway pressure (Pmean) over time were significantly different between the two groups (P = 0.044). Although ERV provided a significantly higher Pmean than CRV during surgery, the changes in PaO 2  did not differ between the two groups.",2019,The changes in partial arterial carbon dioxide pressure over time were significantly different between the two groups (P = 0.040).,"['overweight and obese patients', 'Fifty adult patients with a body mass index of ≥25\u2009kg/m 2', 'overweight and obese patients undergoing posterior spine surgery', 'patients with obesity']","['ventilatory strategy', 'conventional ratio ventilation (CRV) of 1:2 and the equal ratio ventilation (ERV', 'Prolonged inspiratory to expiratory (I:E) ratio ventilation']","['mean airway pressure (Pmean) over time', 'partial arterial carbon dioxide pressure over time', 'Arterial oxygenation and respiratory mechanics', 'arterial oxygenation and respiratory mechanics', 'partial arterial oxygen pressure (PaO 2 ) over time']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0600466', 'cui_str': 'ERVs'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}]",50.0,0.0465739,The changes in partial arterial carbon dioxide pressure over time were significantly different between the two groups (P = 0.040).,"[{'ForeName': 'Kyung Mi', 'Initials': 'KM', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jung Ju', 'Initials': 'JJ', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Dongchul', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Wol Seon', 'Initials': 'WS', 'LastName': 'Jung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Su Bin', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Hyun Jeong', 'Initials': 'HJ', 'LastName': 'Kwak', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea. hyun615@gilhospital.com.'}]",Scientific reports,['10.1038/s41598-019-53194-2']
1162,31701163,Neural correlates of oxytocin and cue reactivity in cocaine-dependent men and women with and without childhood trauma.,"RATIONALE


Women with cocaine use disorder have worse treatment outcomes compared with men. Sex differences in cocaine addiction may be driven by differences in neurobiology or stress reactivity. Oxytocin is a potential therapeutic for stress reduction in substance use disorders, but no studies have examined the effect of oxytocin on neural response to drug cues in individuals with cocaine use disorders or potential sex differences in this response.
OBJECTIVES


The goal of this study was to examine the effect of intranasal oxytocin on cocaine cue reactivity in cocaine dependence, modulated by gender and history of childhood trauma.
METHODS


Cocaine-dependent men with (n = 24) or without (n = 19) a history of childhood trauma and cocaine-dependent women with (n = 16) or without (n = 8) a history of childhood trauma completed an fMRI cocaine cue reactivity task under intranasal placebo or oxytocin (40 IU) on two different days. fMRI response was measured in the right amygdala and dorsomedial prefrontal cortex (DMPFC).
RESULTS


In the DMPFC, oxytocin reduced fMRI response to cocaine cues across all subject groups. However, in the amygdala, only men with a history of childhood trauma showed a significantly reduced fMRI response to cocaine cues on oxytocin versus placebo, while women with a history of childhood trauma showed an enhanced amygdala response to cocaine cues following oxytocin administration. Cocaine-dependent subjects with no history of childhood trauma showed no effect of oxytocin on amygdala response.
CONCLUSIONS


Oxytocin can reduce cue reactivity in cocaine dependence, but its effect is modified by sex and childhood trauma history. Whereas men with cocaine dependence may benefit from oxytocin administration, additional studies are needed to determine whether oxytocin can be an effective therapeutic for cocaine-dependent women.",2019,"In the DMPFC, oxytocin reduced fMRI response to cocaine cues across all subject groups.","['Cocaine-dependent men with (n = 24) or without (n = 19) a history of childhood trauma and cocaine-dependent women with (n = 16) or without (n = 8) a history of childhood trauma completed an', 'dependent subjects with no history of childhood trauma', 'Women with cocaine use disorder', 'cocaine-dependent men and women with and without childhood trauma']","['Cocaine', 'oxytocin', 'placebo', 'Oxytocin', 'fMRI cocaine cue reactivity task under intranasal placebo or oxytocin', 'intranasal oxytocin', 'DMPFC, oxytocin']",['fMRI response'],"[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}]",,0.110319,"In the DMPFC, oxytocin reduced fMRI response to cocaine cues across all subject groups.","[{'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Joseph', 'Affiliation': 'Department of Neuroscience, Medical University of South Carolina, 96 Jonathan Lucas St., Clinical Sciences Building Room 325E, Charleston, SC, 29425, USA. josep@musc.edu.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'McRae-Clark', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 96 Jonathan Lucas St., Clinical Sciences Building Room 325E, Charleston, SC, 29425, USA.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Sherman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 96 Jonathan Lucas St., Clinical Sciences Building Room 325E, Charleston, SC, 29425, USA.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, 96 Jonathan Lucas St., Clinical Sciences Building Room 325E, Charleston, SC, 29425, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Moran-Santa Maria', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 96 Jonathan Lucas St., Clinical Sciences Building Room 325E, Charleston, SC, 29425, USA.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 96 Jonathan Lucas St., Clinical Sciences Building Room 325E, Charleston, SC, 29425, USA.'}]",Psychopharmacology,['10.1007/s00213-019-05360-7']
1163,30975627,"Erlotinib plus bevacizumab versus erlotinib alone in patients with EGFR-positive advanced non-squamous non-small-cell lung cancer (NEJ026): interim analysis of an open-label, randomised, multicentre, phase 3 trial.","BACKGROUND


Resistance to first-generation or second-generation EGFR tyrosine kinase inhibitor (TKI) monotherapy develops in almost half of patients with EGFR-positive non-small-cell lung cancer (NSCLC) after 1 year of treatment. The JO25567 phase 2 trial comparing erlotinib plus bevacizumab combination therapy with erlotinib monotherapy established the activity and manageable toxicity of erlotinib plus bevacizumab in patients with NSCLC. We did a phase 3 trial to validate the results of the JO25567 study and report here the results from the preplanned interim analysis.
METHODS


In this prespecified interim analysis of the randomised, open-label, phase 3 NEJ026 trial, we recruited patients with stage IIIB-IV disease or recurrent, cytologically or histologically confirmed non-squamous NSCLC with activating EGFR genomic aberrations from 69 centres across Japan. Eligible patients were at least 20 years old, and had an Eastern Cooperative Oncology Group performance status of 2 or lower, no previous chemotherapy for advanced disease, and one or more measurable lesions based on Response Evaluation Criteria in Solid Tumours (1.1). Patients were randomly assigned (1:1) to receive oral erlotinib 150 mg per day plus intravenous bevacizumab 15 mg/kg once every 21 days, or erlotinib 150 mg per day monotherapy. Randomisation was done by minimisation, stratified by sex, smoking status, clinical stage, and EGFR mutation subtype. The primary endpoint was progression-free survival. This study is ongoing; the data cutoff for this prespecified interim analysis was Sept 21, 2017. Efficacy was analysed in the modified intention-to-treat population, which included all randomly assigned patients who received at least one dose of treatment and had at least one response evaluation. Safety was analysed in all patients who received at least one dose of study drug. The trial is registered with the University Hospital Medical Information Network Clinical Trials Registry, number UMIN000017069.
FINDINGS


Between June 3, 2015, and Aug 31, 2016, 228 patients were randomly assigned to receive erlotinib plus bevacizumab (n=114) or erlotinib alone (n=114). 112 patients in each group were evaluable for efficacy, and safety was evaluated in 112 patients in the combination therapy group and 114 in the monotherapy group. Median follow-up was 12·4 months (IQR 7·0-15·7). At the time of interim analysis, median progression-free survival for patients in the erlotinib plus bevacizumab group was 16·9 months (95% CI 14·2-21·0) compared with 13·3 months (11·1-15·3) for patients in the erlotinib group (hazard ratio 0·605, 95% CI 0·417-0·877; p=0·016). 98 (88%) of 112 patients in the erlotinib plus bevacizumab group and 53 (46%) of 114 patients in the erlotinib alone group had grade 3 or worse adverse events. The most common grade 3-4 adverse event was rash (23 [21%] of 112 patients in the erlotinib plus bevacizumab group vs 24 [21%] of 114 patients in the erlotinib alone group). Nine (8%) of 112 patients in the erlotinib plus bevacizumab group and five (4%) of 114 patients in the erlotinib alone group had serious adverse events. The most common serious adverse events were grade 4 neutropenia (two [2%] of 112 patients in the erlotinib plus bevacizumab group) and grade 4 hepatic dysfunction (one [1%] of 112 patients in the erlotinib plus bevacizumab group and one [1%] of 114 patients in the erlotinib alone group). No treatment-related deaths occurred.
INTERPRETATION


The results of this interim analysis showed that bevacizumab plus erlotinib combination therapy improves progression-free survival compared with erlotinib alone in patients with EGFR-positive NSCLC. Future studies with longer follow-up, and overall survival and quality-of-life data will be required to further assess the efficacy of this combination in this setting.
FUNDING


Chugai Pharmaceutical.",2019,The most common grade 3-4 adverse event was rash (23 [21%] of 112 patients in the erlotinib plus bevacizumab group vs 24 [21%] of 114 patients in the erlotinib alone group).,"['patients with stage IIIB-IV disease or recurrent, cytologically or histologically confirmed non-squamous NSCLC with activating EGFR genomic aberrations from 69 centres across Japan', 'patients with EGFR-positive NSCLC', '112 patients in the combination therapy group and 114 in the monotherapy group', 'patients with NSCLC', 'patients with EGFR-positive advanced non-squamous non-small-cell lung cancer (NEJ026', 'Eligible patients were at least 20 years old, and had an Eastern Cooperative Oncology Group performance status of 2 or lower, no previous chemotherapy for advanced disease, and one or more measurable lesions based on Response Evaluation Criteria in Solid Tumours (1.1', 'Between June 3, 2015, and Aug 31, 2016, 228 patients']","['bevacizumab', 'Erlotinib plus bevacizumab', 'erlotinib alone', 'oral erlotinib 150 mg per day plus intravenous bevacizumab', 'erlotinib 150 mg per day monotherapy', 'erlotinib plus bevacizumab', 'bevacizumab plus erlotinib combination therapy']","['Efficacy', 'grade 3 or worse adverse events', 'median progression-free survival', 'serious adverse events', 'progression-free survival', 'grade 4 hepatic dysfunction', 'activity and manageable toxicity', 'efficacy, and safety', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0887950', 'cui_str': 'Genomics'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0303405', 'cui_str': '114In radioisotope'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C4517491', 'cui_str': 'One point one'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2978152', 'cui_str': 'erlotinib 150 MG [Tarceva]'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0086565', 'cui_str': 'Liver Dysfunction'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",228.0,0.181871,The most common grade 3-4 adverse event was rash (23 [21%] of 112 patients in the erlotinib plus bevacizumab group vs 24 [21%] of 114 patients in the erlotinib alone group).,"[{'ForeName': 'Haruhiro', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': 'Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Fukuhara', 'Affiliation': 'Miyagi Cancer Center, Natori, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Furuya', 'Affiliation': 'St Marianna University School of Medicine, Kawasaki, Japan.'}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Miyagi Cancer Center, Natori, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Sendai Kousei Hospital, Sendai, Japan.'}, {'ForeName': 'Shunichiro', 'Initials': 'S', 'LastName': 'Iwasawa', 'Affiliation': 'Chiba University, Chiba, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Tsunezuka', 'Affiliation': 'Ishikawa Prefectural Central Hospital, Kanazawa, Japan.'}, {'ForeName': 'Ou', 'Initials': 'O', 'LastName': 'Yamaguchi', 'Affiliation': 'Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Morihito', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': 'Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Kozo', 'Initials': 'K', 'LastName': 'Yoshimori', 'Affiliation': 'Fukujuji Hospital, Tokyo, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Nakachi', 'Affiliation': 'Saiseikai Utsunomiya Hospital, Utsunomiya, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Gemma', 'Affiliation': 'Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Azuma', 'Affiliation': 'Kurume University, Kurume, Japan.'}, {'ForeName': 'Futoshi', 'Initials': 'F', 'LastName': 'Kurimoto', 'Affiliation': 'Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Tsubata', 'Affiliation': 'Shimane University, Shimane, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Fujita', 'Affiliation': 'National Hospital Organization Asahikawa Medical Center, Asahikawa, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Nagashima', 'Affiliation': 'Iwate Medical University School of Medicine, Morioka, Japan.'}, {'ForeName': 'Gyo', 'Initials': 'G', 'LastName': 'Asai', 'Affiliation': 'Aichi Cancer Center Aichi Hospital, Okazaki, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Watanabe', 'Affiliation': 'Niigata University Medical and Dental Hospital, Niigata, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Miyazaki', 'Affiliation': 'Suita Municipal Hospital, Osaka, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hagiwara', 'Affiliation': 'Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Nukiwa', 'Affiliation': 'Tohoku University, Miyagi, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Maemondo', 'Affiliation': 'Iwate Medical University School of Medicine, Morioka, Japan. Electronic address: maemondo-ma693@aioros.ocn.ne.jp.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30035-X']
1164,30771362,Improving child weight management uptake through enhanced National Child Measurement Programme parental feedback letters: A randomised controlled trial.,"This single-blind, pragmatic, cluster randomised controlled trial aims to investigate uptake of children's weight management services in response to enhanced National Child Measurement Programme (NCMP) letters providing weight status feedback to parents in three English counties in 2015. Parents of 2642 overweight or very overweight (obese) children aged 10-11 years received an intervention or control letter informing them of their child's weight status. Intervention letters included (i) a visual tool to help weight status recognition, (ii) a social norms statement, and for very overweight children, (iii) a prepopulated booking form for weight management services. The primary outcome was weight management service enrolment. Additional outcome measures included attendance at and contact made with weight management services, and a number of self-report variables. A small effect was observed, with intervention parents being significantly more likely to enrol their children in weight management services (4.33% of Intervention group) than control parents (2.19% of Control group) in both unadjusted (OR = 2.08, p = .008) and adjusted analyses (AOR = 2.48, p = .001). A similar picture emerged for contact with services (4.80% Intervention vs. 2.41% Control; OR = 2.10, p = .003; AOR = 2.46, p < .001) and attendance at services, although group differences in the latter measure were not significant after corrections for multiple comparisons (1.89% Intervention vs. 1.02% Control; AOR = 2.11, p = .047). No effects were found on self-report variables. Theoretically informed weight status feedback letters appear to be an effective strategy to improve enrolment in paediatric weight management services.",2019,"A similar picture emerged for contact with services (4.80% Intervention vs. 2.41% Control; OR = 2.10, p = .003; AOR = 2.46, p < .001) and attendance at services, although group differences in the latter measure were not significant after corrections for multiple comparisons (1.89% Intervention vs. 1.02% Control; AOR = 2.11, p = .047).","['Parents of 2642 overweight or very overweight (obese) children aged 10-11\u202fyears', ""children's weight management services in response to enhanced National Child Measurement Programme (NCMP) letters providing weight status feedback to parents in three English counties in 2015""]","[""intervention or control letter informing them of their child's weight status"", 'Intervention letters included (i) a visual tool to help weight status recognition, (ii) a social norms statement, and for very overweight children, (iii) a prepopulated booking form for weight management services']","['weight management service enrolment', 'weight management services', 'attendance at and contact made with weight management services, and a number of self-report variables']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0454838', 'cui_str': 'English counties (geographic location)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",2642.0,0.0642017,"A similar picture emerged for contact with services (4.80% Intervention vs. 2.41% Control; OR = 2.10, p = .003; AOR = 2.46, p < .001) and attendance at services, although group differences in the latter measure were not significant after corrections for multiple comparisons (1.89% Intervention vs. 1.02% Control; AOR = 2.11, p = .047).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sallis', 'Affiliation': 'PHE Behavioural Insights Team (PHE BI), Research, Translation & Innovation Division, 6th Floor, Wellington House, 133-155 Waterloo Road, London SE1 8UG, United Kingdom of Great Britain and Northern Ireland. Electronic address: anna.sallis@phe.gov.uk.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Porter', 'Affiliation': 'PHE Behavioural Insights Team (PHE BI), Research, Translation & Innovation Division, 6th Floor, Wellington House, 133-155 Waterloo Road, London SE1 8UG, United Kingdom of Great Britain and Northern Ireland; School of Psychology, University of Exeter, Washington Singer Laboratories, Perry Road, Exeter EX4 4QG, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Tan', 'Affiliation': 'PHE Behavioural Insights Team (PHE BI), Research, Translation & Innovation Division, 6th Floor, Wellington House, 133-155 Waterloo Road, London SE1 8UG, United Kingdom of Great Britain and Northern Ireland; HM Courts and Tribunals Services, 6.02, 102 Petty France, London SW1H 9AJ, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Howard', 'Affiliation': 'Leicestershire County Council, County Hall, Glenfield, Leicestershire LE3 8TB, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'PHE Behavioural Insights Team (PHE BI), Research, Translation & Innovation Division, 6th Floor, Wellington House, 133-155 Waterloo Road, London SE1 8UG, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jones', 'Affiliation': 'Human Nutrition Research Centre and Institute of Health & Society, Newcastle University, M1.51 William Leech Building, Framlington Place, Newcastle-Upon-Tyne NE2 4HH, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ells', 'Affiliation': 'School of Health and Social Care, Teesside University, Middlesbrough, TS1 3BA, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Adamson', 'Affiliation': 'Human Nutrition Research Centre and Institute of Health & Society, Newcastle University, M1.51 William Leech Building, Framlington Place, Newcastle-Upon-Tyne NE2 4HH, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Health Intelligence Division, Public Health England, Wellington House, 133-155 Waterloo Road, London SE1 8UG, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Vlaev', 'Affiliation': 'Warwick Business School, University of Warwick, Scarman Road, Coventry CV4 7AL, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Chadborn', 'Affiliation': 'PHE Behavioural Insights Team (PHE BI), Research, Translation & Innovation Division, 6th Floor, Wellington House, 133-155 Waterloo Road, London SE1 8UG, United Kingdom of Great Britain and Northern Ireland.'}]",Preventive medicine,['10.1016/j.ypmed.2019.01.023']
1165,30980514,Efficacy and Safety of Intravenous Golimumab Through One Year in Patients With Active Psoriatic Arthritis.,"OBJECTIVE


The present study was undertaken to evaluate the safety and efficacy of intravenous (IV) golimumab in patients with active psoriatic arthritis (PsA) through 1 year.
METHODS


GO-VIBRANT was a phase III, randomized, placebo-controlled trial of 480 adults with active PsA. Patients were randomized to receive IV placebo (n = 239) or golimumab 2 mg/kg (n = 241) at weeks 0, 4, and every 8 weeks, with placebo crossover to golimumab at weeks 24, 28, and every 8 weeks thereafter. Efficacy through week 52 was assessed using the American College of Rheumatology (ACR) ≥20%, 50%, or 70% improvement criteria (ACR20/50/70), and the Psoriasis Area and Severity Index ≥75% improvement criteria (PASI75). Radiographic progression was measured using the PsA-modified Sharp/van der Heijde score (SHS). Adverse events (AEs) were monitored through week 60.
RESULTS


The primary and major secondary end points through week 24 were achieved. At week 52, 76.8% of patients in the golimumab group and 77.0% in the placebo-crossover group achieved an ACR20 response, 58.1% and 53.6%, respectively, achieved an ACR50 response, and 38.6% and 33.9%, respectively, achieved an ACR70 response. Among patients with ≥3% body surface area affected, 71.9% in the golimumab group and 60.6% in the placebo-crossover group achieved a PASI75 response at week 52. Mean change from baseline in total SHS at week 52 was -0.5 in the golimumab group and 0.8 in the placebo-crossover group. Through week 60, 50.9% of all golimumab-treated patients had ≥1 AE, and 5.2% had ≥1 serious AE. There were no opportunistic infections, 2 malignancies, and 1 death in patients treated with golimumab.
CONCLUSION


Sustained improvements in joint and skin disease in patients with PsA were maintained through 1 year in the GO-VIBRANT study. No new safety signals for IV golimumab were identified.",2019,"CONCLUSION


Sustained improvements in joint and skin disease in patients with PsA were maintained through 1 year in the GO-VIBRANT study.","['Patients with Active Psoriatic Arthritis', 'patients with active psoriatic arthritis (PsA) through 1 year', '480 adults with active PsA. Patients', 'patients with PsA']","['intravenous golimumab', 'Intravenous Golimumab', 'placebo', 'intravenous placebo', 'placebo crossover to golimumab', 'golimumab']","['ACR70 response', 'Psoriasis Area and Severity Index (PASI75); radiographic progression', 'ACR criteria (ACR20/50/70), Health Assessment Questionnaire-Disability Index (HAQ-DI', 'ACR50 response', 'PASI75 response', 'total vdH-S score', 'Efficacy and Safety', 'Adverse events (AEs', 'joint and skin disease', 'ACR20 response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C2353893', 'cui_str': 'golimumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0102923', 'cui_str': 'HAQ'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0037274', 'cui_str': 'Dermatoses'}]",480.0,0.512219,"CONCLUSION


Sustained improvements in joint and skin disease in patients with PsA were maintained through 1 year in the GO-VIBRANT study.","[{'ForeName': 'M Elaine', 'Initials': 'ME', 'LastName': 'Husni', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Kavanaugh', 'Affiliation': 'University of California San Diego, La Jolla.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Murphy', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, Pennsylvania.'}, {'ForeName': 'Dmytro', 'Initials': 'D', 'LastName': 'Rekalov', 'Affiliation': 'Zaporizhzhia Regional Hospital, Zaporozhe, Ukraine.'}, {'ForeName': 'Diane D', 'Initials': 'DD', 'LastName': 'Harrison', 'Affiliation': 'Janssen Research & Development, Spring House, Pennsylvania.'}, {'ForeName': 'Lilianne', 'Initials': 'L', 'LastName': 'Kim', 'Affiliation': 'Janssen Research & Development, Spring House, Pennsylvania.'}, {'ForeName': 'Kim Hung', 'Initials': 'KH', 'LastName': 'Lo', 'Affiliation': 'Janssen Research & Development, Spring House, Pennsylvania.'}, {'ForeName': 'Jocelyn H', 'Initials': 'JH', 'LastName': 'Leu', 'Affiliation': 'Janssen Research & Development, Spring House, Pennsylvania.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Janssen Research & Development, Spring House, Pennsylvania, and University of Pennsylvania, Philadelphia.'}]",Arthritis care & research,['10.1002/acr.23905']
1166,30945297,Effect of pomegranate seed oil supplementation on the GLUT-4 gene expression and glycemic control in obese people with type 2 diabetes: A randomized controlled clinical trial.,"Abnormality in glucose transporter type 4 (GLUT-4) function and insulin secretion are the main causes of type 2 diabetes mellitus (T2DM). Due to adverse effects of antidiabetic drugs, nowadays, nutraceuticals have been of much interest to investigators. The aim of the present study was to determine the effect of pomegranate seed oil (PSO) on the GLUT-4 gene expression and glycemic control in obese people with T2DM. This randomized clinical trial was conducted on 52 obese type 2 diabetic patients for 8 weeks in Tabriz, Iran, in 2018. Patients were divided into the intervention group (n = 26; who consumed daily three capsules containing 1 g PSO) and the placebo group (n = 26; the same amounts paraffin). GLUT-4 gene expression and glycemic indices were evaluated by standard methods. GLUT-4 gene expression was increased significantly in the PSO group. Within-group changes in fasting blood sugar (FBS) and quantitative insulin sensitivity check index were significant in the PSO group. After adjusting the age, gender, and baseline values, FBS was significantly decreased. Insulin concentration, HbA1C, HOMA-IR, and HOMA-β did not manifest significant changes. PSO increased the GLUT-4 gene expression in diabetic patients without any side effects. However, future clinical studies are needed to confirm the obtained results.",2019,"Insulin concentration, HbA1C, HOMA-IR, and HOMA-β did not manifest significant changes.","['52 obese type 2 diabetic patients for 8 weeks in Tabriz, Iran, in 2018', 'obese people with T2DM', 'obese people with type 2 diabetes', 'diabetic patients']","['pomegranate seed oil supplementation', 'placebo', 'consumed daily three capsules containing 1\u2009g PSO', 'pomegranate seed oil (PSO', 'PSO']","['quantitative insulin sensitivity check index', 'fasting blood sugar (FBS', 'GLUT-4 gene expression and glycemic indices', 'GLUT-4 gene expression', 'Insulin concentration, HbA1C, HOMA-IR, and HOMA-β', 'GLUT-4 gene expression and glycemic control']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3256645', 'cui_str': 'POMEGRANATE SEED OIL'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",52.0,0.0660053,"Insulin concentration, HbA1C, HOMA-IR, and HOMA-β did not manifest significant changes.","[{'ForeName': 'Yaser', 'Initials': 'Y', 'LastName': 'Khajebishak', 'Affiliation': 'Talented Student Center, Student Research Committee, Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Payahoo', 'Affiliation': 'Department of Nutrition, Maragheh University of Medical Sciences, Maragheh, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Alivand', 'Affiliation': 'Department of Medical Genetics, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Hamishehkar', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mobasseri', 'Affiliation': 'Endocrinology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Vahide', 'Initials': 'V', 'LastName': 'Ebrahimzadeh', 'Affiliation': 'Department of Nutrition, Maragheh University of Medical Sciences, Maragheh, Iran.'}, {'ForeName': 'Mahdiye', 'Initials': 'M', 'LastName': 'Alipour', 'Affiliation': 'Dental and Periodontal Research Center, Faculty of Dentistry, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Beitollah', 'Initials': 'B', 'LastName': 'Alipour', 'Affiliation': 'Department of Community Nutrition, Faculty of Nutrition, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Journal of cellular physiology,['10.1002/jcp.28561']
1167,32410819,Phase I Study in Healthy Women of a Novel Antimycotic Vaginal Ovule Combining Econazole and Benzydamine.,"Purpose


A novel fixed-dose combination of 150 mg of econazole with 6 mg of benzydamine formulated in vaginal ovules was investigated in a randomised, double-blind, four-parallel group, tolerability, and pharmacokinetic Phase I study in healthy women.
Methods


The fixed-dose combination was compared to econazole and benzydamine single-drug formulations and with placebo after daily applications for 3 consecutive days. Safety and tolerability were evaluated recording the adverse drug reactions, local and general tolerability scores, clinical laboratory assays, and vital signs. Econazole, benzydamine, and its metabolite benzydamine N-oxide pharmacokinetics were investigated after single and multiple applications.
Results


Local reactions were generally absent. Pruritus and pain at the application site were infrequently reported. According to the subjects' evaluations, the overall tolerability of the ovules was rated as excellent or good. No significant effect of any treatment on laboratory parameters, vital signs, body weight, vaginal pH, or ECG was observed. Very low econazole, benzydamine, and benzydamine-N-oxide concentrations were measured in plasma, though quantifiable in almost all samples.
Conclusion


The tested fixed-dose combination showed a good safety profile consistently with the known tolerability of both active substances. In addition, the confirmed low bioavailability of the drugs excludes the possibility of any accumulation effects and limits the risk of undesired systemic effects. This trial is registered at ClinicalTrials.gov with the identifier NCT02720783 last updated on 07 February 2017.",2020,"No significant effect of any treatment on laboratory parameters, vital signs, body weight, vaginal pH, or ECG was observed.","['07 February 2017', 'Healthy Women of a Novel Antimycotic Vaginal Ovule Combining Econazole and Benzydamine', 'healthy women']","['Econazole, benzydamine', '150\u2009mg of econazole with 6\u2009mg of benzydamine', 'placebo']","['Safety and tolerability', 'Pruritus and pain', 'adverse drug reactions, local and general tolerability scores, clinical laboratory assays, and vital signs', 'Very low econazole, benzydamine, and benzydamine-N-oxide concentrations', 'laboratory parameters, vital signs, body weight, vaginal pH, or ECG', 'overall tolerability']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C2718098', 'cui_str': 'Ovule'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013547', 'cui_str': 'Econazole'}, {'cui': 'C0005099', 'cui_str': 'Benzydamine'}]","[{'cui': 'C0013547', 'cui_str': 'Econazole'}, {'cui': 'C0005099', 'cui_str': 'Benzydamine'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0013547', 'cui_str': 'Econazole'}, {'cui': 'C0005099', 'cui_str': 'Benzydamine'}, {'cui': 'C0081742', 'cui_str': 'benzydamine N-oxide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.138482,"No significant effect of any treatment on laboratory parameters, vital signs, body weight, vaginal pH, or ECG was observed.","[{'ForeName': 'A F D', 'Initials': 'AFD', 'LastName': 'Di Stefano', 'Affiliation': 'CROSS Research S.A., Via F. A. Giorgioli, 14, CH-6864 Arzo, Switzerland.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Radicioni', 'Affiliation': 'CROSS Research S.A., Via F. A. Giorgioli, 14, CH-6864 Arzo, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vaccani', 'Affiliation': 'CROSS Research S.A., Via F. A. Giorgioli, 14, CH-6864 Arzo, Switzerland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Caccia', 'Affiliation': 'Service for Gynaecology and Obstetrics, Ospedale Regionale di Mendrisio, Mendrisio, Switzerland.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Focanti', 'Affiliation': 'Angelini S.p.A., S. Palomba, Rome, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Salvatori', 'Affiliation': 'Angelini S.p.A., S. Palomba, Rome, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Pelacchi', 'Affiliation': 'Angelini S.p.A., S. Palomba, Rome, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Picollo', 'Affiliation': 'Angelini S.p.A., S. Palomba, Rome, Italy.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Rosignoli', 'Affiliation': 'Angelini S.p.A., S. Palomba, Rome, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Olivieri', 'Affiliation': 'Angelini S.p.A., S. Palomba, Rome, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Bovi', 'Affiliation': 'Angelini S.p.A., S. Palomba, Rome, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Comandini', 'Affiliation': 'Angelini S.p.A., S. Palomba, Rome, Italy.'}]",Infectious diseases in obstetrics and gynecology,['10.1155/2020/7201840']
1168,32410922,Personalization of CM Injection Protocols in Coronary Computed Tomographic Angiography (People CT Trial).,"Aim


To evaluate the performance of three contrast media (CM) injection protocols for cardiac computed tomography angiography (CCTA) based on body weight (BW), lean BW (LBW), and cardiac output (CO).  Materials and methods . A total of 327 consecutive patients referred for CCTA were randomized into one of the three CM injection protocols, where CM injection was based on either BW (112 patients), LBW (108 patients), or CO (107 patients). LBW and CO were calculated via formulas. All scans were ECG-gated and performed on a third-generation dual-source CT with 70-120 kV (automated tube voltage selection) and 100 kV qual.ref /330 mAs qual.ref . CM injection protocols were also adapted to scan time and tube voltage. The primary outcome was the proportion of patients with optimal intravascular attenuation (325-500 HU). Secondary outcomes were mean and standard deviation of intravascular attenuation values (HU), contrast-to-noise ratio (CNR), and subjective image quality with a 4-point Likert scale (1 = poor/2 = sufficient/3 = good/4 = excellent). The  t -test for independent samples was used for pairwise comparisons between groups, and a chi-square test ( χ 2) was used to compare categorical variables between groups. All  p  values were 2-sided, and a  p  < 0.05 was considered statistically significant.
Results


Mean overall HU and CNR were 423 ± 60HU/14 ± 3 (BW), 404 ± 62HU/14 ± 3 (LBW), and 413 ± 63HU/14 ± 3 (CO) with a significant difference between groups BW and LBW ( p =0.024). The proportion of patients with optimal intravascular attenuation (325-500 HU) was 83.9%, 84.3%, and 86.9% for groups BW, LBW, and CO, respectively, and between-group differences were small and nonsignificant. Mean CNR was diagnostic (≥10) in all groups. The proportion of scans with good-excellent image quality was 94.6%, 86.1%, and 90.7% in the BW, LBW, and CO groups, respectively. The difference between proportions was significant between the BW and LBW groups.
Conclusion


Personalization of CM injection protocols based on BW, LBW, and CO, and scan time and tube voltage in CCTA resulted in low variation between patients in terms of intravascular attenuation and a high proportion of scans with an optimal intravascular attenuation. The results suggest that personalized CM injection protocols based on LBW or CO have no additional benefit when compared with CM injection protocols based on BW.",2020,The results suggest that personalized CM injection protocols based on LBW or CO have no additional benefit when compared with CM injection protocols based on BW.,['327 consecutive patients referred for CCTA'],['three contrast media (CM) injection protocols for cardiac computed tomography angiography (CCTA'],"['mean and standard deviation of intravascular attenuation values (HU), contrast-to-noise ratio (CNR), and subjective image quality with a 4-point Likert scale', 'proportion of patients with optimal intravascular attenuation', 'LBW and CO', 'proportion of scans with good-excellent image quality', 'body weight (BW), lean BW (LBW), and cardiac output (CO', 'Mean CNR', 'Mean overall HU and CNR', 'BW, LBW, and CO, and scan time and tube voltage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0175730', 'cui_str': 'Tube'}]",327.0,0.0186532,The results suggest that personalized CM injection protocols based on LBW or CO have no additional benefit when compared with CM injection protocols based on BW.,"[{'ForeName': 'N G', 'Initials': 'NG', 'LastName': 'Eijsvoogel', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center+, P. Debyelaan 25, PO Box 5800, 6202 AZ Maastricht, Netherlands.'}, {'ForeName': 'B M F', 'Initials': 'BMF', 'LastName': 'Hendriks', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center+, P. Debyelaan 25, PO Box 5800, 6202 AZ Maastricht, Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Nelemans', 'Affiliation': 'Department of Epidemiology, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mihl', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center+, P. Debyelaan 25, PO Box 5800, 6202 AZ Maastricht, Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Willigers', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center+, P. Debyelaan 25, PO Box 5800, 6202 AZ Maastricht, Netherlands.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Martens', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center+, P. Debyelaan 25, PO Box 5800, 6202 AZ Maastricht, Netherlands.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Wildberger', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center+, P. Debyelaan 25, PO Box 5800, 6202 AZ Maastricht, Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Das', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center+, P. Debyelaan 25, PO Box 5800, 6202 AZ Maastricht, Netherlands.'}]",Contrast media & molecular imaging,['10.1155/2020/5407936']
1169,30932133,The Effect of Branched Chain Amino Acids-Enriched Nutritional Supplements on Activities of Daily Living and Muscle Mass in Inpatients with Gait Impairments: A Randomized Controlled Trial.,"OBJECTIVE


To investigate the effects of continuous intervention with branched chain amino acids-enriched nutritional supplements from the acute phase to convalescent rehabilitation wards in inpatients with gait impairments.
DESIGN


Open-label, randomized, parallel-group comparison study (UMIN Clinical Trials Registry ID: UMIN000018640).
SETTING


Acute care and convalescent rehabilitation wards.
PARTICIPANTS


We studied 80 patients undergoing stand/gait training.
INTERVENTIONS


Participants in the intervention group (RJ group) received nutritional supplements (jelly foods comprising 2500 mg BCAA and 20 IU vitamin D) twice a day until hospital discharge.
MEASUREMENTS


The primary outcome was the motor components of the Functional Independence Measure (FIM-m), and the secondary outcome was skeletal muscle mass index.
RESULTS


Analyses were conducted on 55 patients who were able to perform stand/gait training continuously from the acute until the recovery phases. FIM-m was significantly elevated in the RJ group and the control group , but no difference was noted between the two groups. Only the RJ group showed a significant increase in skeletal muscle mass index, and the amount of variation was significantly different between the two groups (the control group decreased an average of 2.2% and the RJ group increased an average of 4.3%; P = 0.014). A significant decrease in body weight was found only in the control group (P = 0.084).
CONCLUSIONS


Nutritional interventions using branched chain amino acids (BCAA)-enriched nutritional supplements demonstrated no significant difference in activities of daily living; however, an increase in skeletal muscle mass was noted. Skeletal muscle mass and body weight differed significantly between the two groups, and BCAA-enriched nutritional supplements intake in acute and convalescent rehabilitation wards may be effective for the prevention of malnutrition and sarcopenia.",2019,"FIM-m was significantly elevated in the RJ group and the control group , but no difference was noted between the two groups.","['80 patients undergoing stand/gait training', 'Inpatients with Gait Impairments', 'Acute care and convalescent rehabilitation wards', '55 patients who were able to perform stand/gait training continuously from the acute until the recovery phases', 'inpatients with gait impairments']","['Branched Chain Amino Acids-Enriched Nutritional Supplements', 'RJ', 'continuous intervention with branched chain amino acids-enriched nutritional supplements', 'nutritional supplements (jelly foods comprising 2500 mg BCAA and 20 IU vitamin D']","['skeletal muscle mass', 'skeletal muscle mass index', 'FIM-m', 'Skeletal muscle mass and body weight', 'amount of variation', 'motor components of the Functional Independence Measure (FIM-m), and the secondary outcome was skeletal muscle mass index', 'activities of daily living', 'body weight', 'Activities of Daily Living and Muscle Mass']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure (procedure)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0453543', 'cui_str': 'Jello'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C4319601', 'cui_str': '2500 (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure (assessment scale)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}]",80.0,0.0975411,"FIM-m was significantly elevated in the RJ group and the control group , but no difference was noted between the two groups.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Moriwaki', 'Affiliation': 'Misa Moriwaki MD, Department of Rehabilitation Medicine, Midorigaoka Hospital, 3-13-1 Makami-cho, Takatsuki, Osaka, Japan 569-1121, Tel.: +81-72-681-5717, Fax: +81-72-681-5796, E-mail: hanamizuki.rehab@gmail.com.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wakabayashi', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sakata', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Domen', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-019-1172-3']
1170,30932134,Regulation of Amino Acid Transporters and Sensors in Response to a High protein Diet: A Randomized Controlled Trial in Elderly Men.,"BACKGROUND


The mammalian target of rapamycin complex 1 (mTORC1) is fundamental for many cellular processes, yet it is often dysregulated with aging. Increased amino acid (AA) availability is correlated with the expression of AA transporters (AAT) and mTORC1 activity. Although many AA sensors and mediators have been proposed to relay the AA signal to mTORC1, it has not yet been determined if chronic dietary intervention affects the expression of AAT, sensors and mediators and their relationships with mTORC1 activity.
OBJECTIVE AND DESIGN


This study investigated whether the consumption of a diet containing either the current recommended daily allowance (RDA) of protein intake (0.8 g/kg/d) or twice the RDA (2RDA) for ten weeks affected the expression of targets associated with AA transport, sensing and mTORC1 regulation in 26 older men (70-81 years).
METHOD


Muscle biopsies were collected before and after the intervention under fasting conditions. Diets were controlled by providing fully prepared meals and snacks. Western blot and quantitative polymerase chain reaction were used to measure protein and gene expression respectively.
RESULTS


Consumption of 2RDA reduced the protein expression of L-type amino acid transporter 1 (LAT1). However, plasma leucine concentration and basal mTORC1 activity were unaltered. The downregulation of LAT1 did not affect the expression of AA sensors and mediators, including leucyl tRNA synthetase (LRS), cytosolic arginine sensor for mTORC1 (CASTOR1), Sestrin2 and Rag proteins. Instead, total ribosomal protein S6 (RPS6) was upregulated with 2RDA.
CONCLUSION


Ten weeks of 2RDA diet did not affect the fasting mTORC1 signaling, but increased total RPS6 might suggest improved muscular translational capacity to maintain muscular mass.",2019,"The downregulation of LAT1 did not affect the expression of AA sensors and mediators, including leucyl tRNA synthetase (LRS), cytosolic arginine sensor for mTORC1 (CASTOR1), Sestrin2 and Rag proteins.","['26 older men (70-81 years', 'Elderly Men']",['diet containing either the current recommended daily allowance (RDA) of protein intake (0.8 g/kg/d) or twice the RDA (2RDA'],"['total ribosomal protein S6 (RPS6', 'expression of AA sensors and mediators, including leucyl tRNA synthetase (LRS), cytosolic arginine sensor for mTORC1 (CASTOR1), Sestrin2 and Rag proteins', 'Increased amino acid (AA) availability', 'plasma leucine concentration and basal mTORC1 activity', 'protein expression of L-type amino acid transporter 1 (LAT1', 'fasting mTORC1 signaling']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0524337', 'cui_str': 'Elderly man (person)'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0524786', 'cui_str': 'Recommended Daily Allowances'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C1720725', 'cui_str': 'Twice'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0073336', 'cui_str': 'Ribosomal Protein S6'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0023414', 'cui_str': 'Leucine-tRNA Synthetase'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C3888046', 'cui_str': 'mTORC1 Complex'}, {'cui': 'C0380301', 'cui_str': 'LERK-7 Protein'}, {'cui': 'C1291157', 'cui_str': 'Increased amino acid'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0949771', 'cui_str': 'Amino Acid Transporter'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]",,0.0337827,"The downregulation of LAT1 did not affect the expression of AA sensors and mediators, including leucyl tRNA synthetase (LRS), cytosolic arginine sensor for mTORC1 (CASTOR1), Sestrin2 and Rag proteins.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Zeng', 'Affiliation': 'Dr. Cameron Mitchell Faculty of Education | School of Kinesiology, The University of British Columbia | Vancouver Campus, 2553 Wesbrook Mall | Vancouver British Columbia | V6T 1Z3 Canada, Phone 604 827 2072| Cell 604 790 3815, cameron.mitchell@ubc.ca.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Prodhan', 'Affiliation': ''}, {'ForeName': 'R F', 'Initials': 'RF', 'LastName': ""D'Souza"", 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ramzan', 'Affiliation': ''}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Mitchell', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'S O', 'Initials': 'SO', 'LastName': 'Knowles', 'Affiliation': ''}, {'ForeName': 'N C', 'Initials': 'NC', 'LastName': 'Roy', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sjödin', 'Affiliation': ''}, {'ForeName': 'K-H', 'Initials': 'KH', 'LastName': 'Wagner', 'Affiliation': ''}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Milan', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cameron-Smith', 'Affiliation': ''}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Mitchell', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-019-1171-4']
1171,32410849,Pioglitazone Metformin Complex Improves Polycystic Ovary Syndrome Comorbid Psychological Distress via Inhibiting NLRP3 Inflammasome Activation: A Prospective Clinical Study.,"Objective


This study aimed at investigating the therapeutic effect and mechanism of pioglitazone metformin complex preparation (PM) in polycystic ovary syndrome (PCOS) comorbid psychological distress.
Methods


Seventy-five patients with PCOS comorbid psychological distress were randomly allocated into the PM, metformin, and placebo groups. The primary efficacy measure was the change from baseline to week 12 on the Symptom Checklist 90-R (SCL-90-R) scores. NLRP3 inflammasome, IL-1 β , IL-6, TNF- α , and biochemical parameters were determined at baseline and at week 12. The participants were required to meet the criteria for PCOS (Rotterdam, NIH) and psychological distress (any factor scores of SCL - 90 - R > 2).
Results


The participants had significantly high scores on the SCL-90-R scales of anxiety and depression. PM significantly decreased anxiety and depression symptom severity (from 2.31 ± 0.75 to 1.65 ± 0.38,  p  < 0.001, and from 2.08 ± 0.74 to 1.61 ± 0.46,  p  = 0.010, at week 12, respectively). PM significantly decreased the expression of NRPL3 and caspase-1. Patients in the PM group experienced a significant reduction in IL-1 β  (from 98.42 ± 14.38 to 71.76 ± 13.66,  p  = 0.02), IL-6 (from 87.51 ± 8.74 to 71.98 ± 15.87,  p  = 0.02), and TNF- α  (from 395.33 ± 88.55 to 281.98 ± 85.69,  p  = 0.04). PM was superior to metformin in reducing total testosterone (2.24 ± 0.74 versus 3.06 ± 0.83,  p  = 0.024, at week 12).
Conclusions


This study is the first to reveal that PM alleviates psychological distress via inhibiting NLRP3 inflammasome and improves several markers, including total testosterone.",2020,"Patients in the PM group experienced a significant reduction in IL-1 β  (from 98.42 ± 14.38 to 71.76 ± 13.66,  p  = 0.02), IL-6","['Polycystic Ovary Syndrome Comorbid Psychological Distress via Inhibiting NLRP3', 'polycystic ovary syndrome (PCOS) comorbid psychological distress', 'Methods\n\n\nSeventy-five patients with PCOS comorbid psychological distress']","['pioglitazone metformin complex preparation (PM', 'Pioglitazone Metformin Complex', 'PM, metformin, and placebo', 'metformin']","['Inflammasome Activation', 'expression of NRPL3 and caspase-1', 'Symptom Checklist 90-R (SCL-90-R) scores', 'IL-1 β', 'total testosterone', 'NLRP3 inflammasome, IL-1 β , IL-6, TNF- α , and biochemical parameters', 'anxiety and depression symptom severity', 'criteria for PCOS (Rotterdam, NIH) and psychological distress', 'SCL-90-R scales of anxiety and depression', 'IL-6']","[{'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2936529', 'cui_str': 'Inflammasome'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0534519', 'cui_str': 'Caspase-1'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",75.0,0.046925,"Patients in the PM group experienced a significant reduction in IL-1 β  (from 98.42 ± 14.38 to 71.76 ± 13.66,  p  = 0.02), IL-6","[{'ForeName': 'Qing-Jun', 'Initials': 'QJ', 'LastName': 'Guo', 'Affiliation': 'Department of Endocrinology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shan', 'Affiliation': 'Department of Traditional Chinese Medicine, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Yi-Feng', 'Initials': 'YF', 'LastName': 'Xu', 'Affiliation': 'Department of Endocrinology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Hu', 'Affiliation': 'Department of Endocrinology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Cui-Lan', 'Initials': 'CL', 'LastName': 'Huo', 'Affiliation': 'Department of Endocrinology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Jing-Yun', 'Initials': 'JY', 'LastName': 'Song', 'Affiliation': 'Department of Endocrinology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Chao-Qun', 'Initials': 'CQ', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Changning Retirement Cadre Rest Care Clinic, Garrison District Shanghai, China.'}, {'ForeName': 'Chao-Qin', 'Initials': 'CQ', 'LastName': 'Yu', 'Affiliation': 'Department of Traditional Chinese Medicine, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Endocrinology, Changhai Hospital, Naval Medical University, Shanghai, China.'}]",Mediators of inflammation,['10.1155/2020/3050487']
1172,31070986,"A phase 2/3 double-blind, randomized, placebo-controlled study to evaluate the safety and immunogenicity of a seasonal trivalent inactivated split-virion influenza vaccine (IVACFLU-S) in healthy adults in Vietnam.","Background : Under the WHO's Global Action Plan for influenza vaccines, we conducted a phase 2-3 study of IVACFLU-S, a trivalent, seasonal inactivated influenza vaccine candidate. Methods : In the phase 2 portion of the study, 252 participants received one dose of 15 mcg hemagglutinin (HA) vaccine per strain or placebo. Following determination of safety, 636 additional participants were randomized in phase 3 to receive vaccine or placebo. Immunogenicity was assessed in a subset of the participants in the phase 3 study. Results : Higher proportion (70%) of participants in the IVACFLU-S arm reported solicited local adverse events (AEs) ( p  < .0001) as compared to placebo (25%). Mild injection site pain and tenderness were most common AEs seen in 55% and 60% of participants in the vaccine group. The solicited systemic AEs were comparable ( p  = .4149). The majority of solicited and unsolicited AEs were mild to moderate in severity. In the vaccine arm for the combined age group of 18-60 years of age, seroconversion against antigens A/H1N1, A/H3N2, and B was achieved in 70.3%, 76.1%, and 54.1% of participants respectively; seroprotection against antigens A/H1N1, A/H3N2, and B was achieved in 83.3%, 86.6%, and 60.3% of participants respectively; and the geometric mean fold rise for the hemagglutinin-inhibition (HI) antibody titers against antigen A/H1N1, A/H3N2, and B were 13.15, 11.85, and 5.87, respectively. Conclusion : This study demonstrates the local reactogenicity, other safety, and immunogenicity of IVACFLU-S, first domestically produced influenza vaccine in Vietnam. ClinicalTrials.gov number  NCT03095599 (March 29, 2017).",2019,Mild injection site pain and tenderness were most common AEs seen in 55% and 60% of participants in the vaccine group.,"['healthy adults in Vietnam', '252 participants', '636 additional participants', 'Vietnam']","['vaccine or placebo', 'placebo', ' ', 'hemagglutinin (HA) vaccine per strain or placebo', 'seasonal trivalent inactivated split-virion influenza vaccine (IVACFLU-S']","['geometric mean fold rise for the hemagglutinin-inhibition (HI) antibody titers', 'solicited systemic AEs', 'seroprotection against antigens', 'solicited local adverse events (AEs', 'Mild injection site pain and tenderness', 'safety and immunogenicity', 'Immunogenicity']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course (qualifier value)'}, {'cui': 'C0042760', 'cui_str': 'Viral Particles'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain (disorder)'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",252.0,0.614258,Mild injection site pain and tenderness were most common AEs seen in 55% and 60% of participants in the vaccine group.,"[{'ForeName': 'Phan Trong', 'Initials': 'PT', 'LastName': 'Lan', 'Affiliation': 'Pasteur Institute, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Nguyen Trong', 'Initials': 'NT', 'LastName': 'Toan', 'Affiliation': 'Pasteur Institute, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Hoang Anh', 'Initials': 'HA', 'LastName': 'Thang', 'Affiliation': 'Pasteur Institute, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Tran Cong', 'Initials': 'TC', 'LastName': 'Thang', 'Affiliation': 'PATH, Hanoi, Viet Nam.'}, {'ForeName': 'Le Van', 'Initials': 'LV', 'LastName': 'Be', 'Affiliation': 'Institute of Vaccines and Medical Biologicals, Nha Trang, Viet Nam.'}, {'ForeName': 'Duong Huu', 'Initials': 'DH', 'LastName': 'Thai', 'Affiliation': 'Institute of Vaccines and Medical Biologicals, Nha Trang, Viet Nam.'}, {'ForeName': 'Vu Minh', 'Initials': 'VM', 'LastName': 'Huong', 'Affiliation': 'PATH, Hanoi, Viet Nam.'}, {'ForeName': 'Nguyen Tuyet', 'Initials': 'NT', 'LastName': 'Nga', 'Affiliation': 'PATH, Hanoi, Viet Nam.'}, {'ForeName': 'Yuxiao', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'PATH, Seattle, WA, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Holt', 'Affiliation': 'PATH, Seattle, WA, USA.'}, {'ForeName': 'Berlanda Scorza', 'Initials': 'BS', 'LastName': 'Francesco', 'Affiliation': 'PATH, Seattle, WA, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Flores', 'Affiliation': 'PATH, Seattle, WA, USA.'}, {'ForeName': 'Tushar', 'Initials': 'T', 'LastName': 'Tewari', 'Affiliation': 'PATH, Seattle, WA, USA.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1613127']
1173,32407060,A split-mouth study comparing piezo electric surgery and traditional rotary burs on impacted third molars in young patients: an intraoperative and postoperative evaluation.,"BACKGROUND


Surgery has been used in many different medical fields, for instance it is used in the field of oral surgery, as a valuable alternative to traditional rotary burs. Its first use dates to 1975 by Horton even if the first effective device for use in dentistry, has been developed by Vercellotti after the year 2000. The hypothesis of this study is that piezosurgery technology is more suitable in terms of specific intra-operative and post-operative evaluations compared to the rotary technology in ostectomy for the avulsion of the third molar germ. The null hypothesis presented is the lack of significant differences between the two technologies after and during surgery.
MATERIAL AND METHODS


Intraoperative and postoperative aspects are evaluated for a comparison between traditional rotary instruments and piezosurgery during germectomies in young patients through a blind randomized study (split-mouth). The surgical technique to employ for each hemi-arch was randomly selected from a computer algorithm. Different criteria were considered during the surgical procedure, in order to compare the two techniques.
RESULTS


The piezoelectric technique demanded more time than traditional rotary method, and the difference was statistically significant both for the time of the entire procedure and the time only required for the ostectomy itself. Post-operative evaluations such as: maximum mouth opening, facial swelling and post- operative pain showed no statistical difference.
CONCLUSIONS


Even if the adopted clinical trial did not highlight any statistical difference the following review of literature showed an encouraging reduction in post-operative discomfort given by the piezosurgery as opposed to the traditional rotary bur surgery. The time taken to complete the operation however, was longer with piezosurgery compared to traditional burs.",2020,"The piezoelectric technique demanded more time than traditional rotary method, and the difference was statistically significant both for the time of the entire procedure and the time only required for the ostectomy itself.",['young patients'],['piezo electric surgery and traditional rotary burs'],"['maximum mouth opening, facial swelling and post- operative pain']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3178856', 'cui_str': 'Piezo-Electric Surgery'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0700351', 'cui_str': 'Bur'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0151602', 'cui_str': 'Facial swelling'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",,0.0339926,"The piezoelectric technique demanded more time than traditional rotary method, and the difference was statistically significant both for the time of the entire procedure and the time only required for the ostectomy itself.","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Zara', 'Affiliation': 'Sapienza Università di Roma, D.A.I Testa-Collo, U.O.C di Odontoiatria Pediatrica, Policlinico Umberto I, Rome, Italy - zarafrancesca94@gmail.com.'}, {'ForeName': 'Claudio M', 'Initials': 'CM', 'LastName': 'De Sanctis', 'Affiliation': 'Sapienza Università di Roma, D.A.I Testa-Collo, U.O.C di Odontoiatria Pediatrica, Policlinico Umberto I, Rome, Italy.'}, {'ForeName': 'Fabia C', 'Initials': 'FC', 'LastName': 'Dede', 'Affiliation': 'Sapienza Università di Roma, D.A.I Testa-Collo, U.O.C di Odontoiatria Pediatrica, Policlinico Umberto I, Rome, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Bossù', 'Affiliation': 'Sapienza Università di Roma, D.A.I Testa-Collo, U.O.C di Odontoiatria Pediatrica, Policlinico Umberto I, Rome, Italy.'}, {'ForeName': 'Gian Luca', 'Initials': 'GL', 'LastName': 'Sfasciotti', 'Affiliation': 'Sapienza Università di Roma, D.A.I Testa-Collo, U.O.C di Odontoiatria Pediatrica, Policlinico Umberto I, Rome, Italy.'}]",Minerva stomatologica,['10.23736/S0026-4970.20.04349-6']
1174,32410951,Angiotensin II-Type I Receptor Antagonism Does Not Influence the Chemoreceptor Reflex or Hypoxia-Induced Central Sleep Apnea in Men.,"Components of the renin-angiotensin system (RAS) situated within the carotid body or central nervous system may promote hypoxia-induced chemoreceptor reflex sensitization or central sleep apnea (CSA). We determined if losartan, an angiotensin-II type-I receptor (AT 1 R) antagonist, would attenuate chemoreceptor reflex sensitivity before or after 8 h of nocturnal hypoxia, and consequently CSA severity. In a double-blind, randomized, placebo-controlled, crossover protocol, 14 men (age: 25 ± 2 years; BMI: 24.6 ± 1.1 kg/m 2 ; means ± SEM) ingested 3 doses of either losartan (50 mg) or placebo every 8 h. Chemoreceptor reflex sensitivity was assessed during hypoxic and hyperoxic hypercapnic ventilatory response (HCVR) tests and during six-20s hypoxic apneas before and after 8 h of sleep in normobaric hypoxia (F  I  O 2  = 0.135). Loop gain was assessed from a ventilatory control model fitted to the ventilatory pattern of CSA recorded during polysomnography. Prior to nocturnal hypoxia, losartan had no effect on either the hyperoxic (losartan: 3.6 ± 1.1, placebo: 4.0 ± 0.6 l/min/mmHg;  P  = 0.9) or hypoxic HCVR (losartan: 5.3 ± 1.4, placebo: 5.7 ± 0.68 l/min/mmHg;  P  = 1.0). Likewise, losartan did not influence either the hyperoxic (losartan: 4.2 ± 1.3, placebo: 3.8 ± 1.1 l/min/mmHg;  P  = 0.5) or hypoxic HCVR (losartan: 6.6 ± 1.8, placebo: 6.3 ± 1.5 l/min/mmHg;  P  = 0.9) after nocturnal hypoxia. Cardiorespiratory responses to apnea and participants' apnea hypopnea indexes during placebo and losartan were similar (73 ± 15 vs. 75 ± 14 events/h;  P  = 0.9). Loop gain, which correlated with CSA severity ( r  = 0.94,  P  < 0.001), was similar between treatments. In summary, in young healthy men, hypoxia-induced CSA severity is strongly associated with loop gain, but the AT 1 R does not modulate chemoreceptor reflex sensitivity before or after 8 h of nocturnal hypoxia.",2020,"Prior to nocturnal hypoxia, losartan had no effect on either the hyperoxic (losartan: 3.6 ± 1.1, placebo: 4.0 ± 0.6 l/min/mmHg;  P  = 0.9) or hypoxic HCVR (losartan: 5.3 ± 1.4, placebo: 5.7 ± 0.68 l/min/mmHg;  P  = 1.0).","['14 men (age: 25 ± 2 years; BMI: 24.6 ± 1.1 kg/m 2 ; means ± SEM) ingested 3 doses of either', 'young healthy men', 'Men']","['losartan, an angiotensin-II type-I receptor (AT 1 R) antagonist', 'Angiotensin II-Type I Receptor Antagonism', 'hyperoxic (losartan', 'losartan', 'placebo and losartan', 'placebo']","['CSA severity', 'chemoreceptor reflex sensitivity', ""Cardiorespiratory responses to apnea and participants' apnea hypopnea indexes"", 'hypoxic and hyperoxic hypercapnic ventilatory response (HCVR) tests']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0520680', 'cui_str': 'Apnea, Central Sleep'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0232041', 'cui_str': 'Chemoreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.124751,"Prior to nocturnal hypoxia, losartan had no effect on either the hyperoxic (losartan: 3.6 ± 1.1, placebo: 4.0 ± 0.6 l/min/mmHg;  P  = 0.9) or hypoxic HCVR (losartan: 5.3 ± 1.4, placebo: 5.7 ± 0.68 l/min/mmHg;  P  = 1.0).","[{'ForeName': 'Courtney V', 'Initials': 'CV', 'LastName': 'Brown', 'Affiliation': 'Centre for Heart, Lung, and Vascular Health, School of Health and Exercise Science, University of British Columbia - Okanagan, Kelowna, BC, Canada.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Boulet', 'Affiliation': 'Centre for Heart, Lung, and Vascular Health, School of Health and Exercise Science, University of British Columbia - Okanagan, Kelowna, BC, Canada.'}, {'ForeName': 'Tyler D', 'Initials': 'TD', 'LastName': 'Vermeulen', 'Affiliation': 'Centre for Heart, Lung, and Vascular Health, School of Health and Exercise Science, University of British Columbia - Okanagan, Kelowna, BC, Canada.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Sands', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States.""}, {'ForeName': 'Richard J A', 'Initials': 'RJA', 'LastName': 'Wilson', 'Affiliation': 'Department of Physiology and Pharmacology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Najib T', 'Initials': 'NT', 'LastName': 'Ayas', 'Affiliation': 'Sleep Disorders Program, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Floras', 'Affiliation': 'University Health Network and Sinai Health System Division of Cardiology, Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Glen E', 'Initials': 'GE', 'LastName': 'Foster', 'Affiliation': 'Centre for Heart, Lung, and Vascular Health, School of Health and Exercise Science, University of British Columbia - Okanagan, Kelowna, BC, Canada.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.00382']
1175,31711041,The Effectiveness of the Mézières Method in Elite Rhythmic Gymnastics Athletes With Low Back Pain: A Randomized Controlled Trial.,"CONTEXT


One of the main reasons why athletes with a high physical condition suffer from low back pain disease is because they often participate in sports that involve disc compression movements during flexion, lifting loads, or torsion movement.
OBJECTIVES


This study aims to examine the effectiveness of the postural treatment of the Mézières method on elite rhythmic gymnastics athletes with low back pain.
DESIGN


Double-blind, randomized, controlled trial.
SETTING


The sports hall of ""Puente Tocinos,"" Murcia, Spain.
PARTICIPANTS


Ninety gymnastics athletes were randomized into 2 parallel groups (intervention: n = 39; control: n = 51), of whom 98.9% were women (women = 89; man = 1).
INTERVENTION


The Mézières method postural therapy was implemented. It lasted about 60 minutes in repeated sessions of 2 to 3 meetings per week by counting in overall 60 sessions during a 24-week period.
MAIN OUTCOME MEASURES


Visual analog scale of pain, sit and reach flexibility test, Runtastic (pedometer performance android application), Roland-Morris Questionnaire for the physical disability, and the Health Status Questionnaire were used.
RESULTS


The univariate analysis of variance and independent sample t test revealed a significant improvement in the intervention group concerning the visual analog scale pain assessment scale (P < .05, ηp2=.625), and, also, the between-groups effect size was high during the 24 sessions of treatment (d > 0.8) compared with the control one. The same situation persists even for Roland-Morris Questionnaire (P < .05, ηp2=.802), physical score (P < .05, ηp2=.613), mental score (P < .05, ηp2=.736), sit and reach flexibility test (P < .05, ηp2=.666), and Runtastic performance (P < .05, ηp2=.790), where the between-groups effect size was high during the 24 sessions of treatment (d > 0.8).
CONCLUSION


The Mézières method treatment performed on athletes with low back pain has caused positive effects on all the outcomes analyzed compared with the ones of control group.",2019,"The univariate analysis of variance and independent sample t test revealed a significant improvement in the intervention group concerning the visual analog scale pain assessment scale (P < .05, ηp2=.625), and, also, the between-groups effect size was high during the 24 sessions of treatment (d > 0.8) compared with the control one.","['elite rhythmic gymnastics athletes with low back pain', 'Ninety gymnastics athletes were randomized into 2 parallel groups (intervention: n = 39; control: n = 51), of whom 98.9% were women (women = 89; man = 1', 'athletes with a high physical condition suffer from low back pain disease', 'The sports hall of ""Puente Tocinos,"" Murcia, Spain', 'Elite Rhythmic Gymnastics Athletes With Low Back Pain']",[],"['Runtastic performance', 'sit and reach flexibility test', 'mental score', 'physical score', 'Visual analog scale of pain, sit and reach flexibility test, Runtastic (pedometer performance android application), Roland-Morris Questionnaire for the physical disability, and the Health Status Questionnaire', 'visual analog scale pain assessment scale']","[{'cui': 'C0018409', 'cui_str': 'Gymnastics'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2356088', 'cui_str': 'Halls'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]",[],"[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0718532', 'cui_str': 'Android'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap (finding)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0030198', 'cui_str': 'Nociception Tests'}, {'cui': 'C0222045'}]",,0.0725206,"The univariate analysis of variance and independent sample t test revealed a significant improvement in the intervention group concerning the visual analog scale pain assessment scale (P < .05, ηp2=.625), and, also, the between-groups effect size was high during the 24 sessions of treatment (d > 0.8) compared with the control one.","[{'ForeName': 'Orges', 'Initials': 'O', 'LastName': 'Lena', 'Affiliation': ''}, {'ForeName': 'Jasemin', 'Initials': 'J', 'LastName': 'Todri', 'Affiliation': ''}, {'ForeName': 'Ardita', 'Initials': 'A', 'LastName': 'Todri', 'Affiliation': ''}, {'ForeName': 'José Luis Martínez', 'Initials': 'JLM', 'LastName': 'Gil', 'Affiliation': ''}, {'ForeName': 'Maria Gomez', 'Initials': 'MG', 'LastName': 'Gallego', 'Affiliation': ''}]",Journal of sport rehabilitation,['10.1123/jsr.2019-0204']
1176,31712967,The Efficacy of a Gambling Prevention Program Among High-School Students.,"Youth problem gambling has become an emergent public health issue, and adolescents constitute a vulnerable age group for the development of gambling-related problems. Although there is research concerning the risk factors of youth problem gambling, rigorous evaluations of the effectiveness of preventive initiatives is still rare. The present study evaluated the efficacy of an integrative intervention to prevent youth problem gambling based on a multidimensional set of factors including gambling-related knowledge, misconceptions, attitudes, gambling frequency, amount of money spent, total hours spent gambling per week, and sensation seeking. A pre- and post-test design was performed with 111 Portuguese high-school students randomly assigned to two groups (experimental and control). The findings demonstrated that the intervention was effective in improving correct knowledge about gambling, reducing misconceptions and attitudes, and in decreasing the total hours spent gambling per week. The intervention was also effective in reducing the number of at-risk/problem gamblers during the study period. Furthermore, these findings were stable after a 6-week follow-up. Overall, the intervention program appeared to be effective in correcting some gambling-related behaviours, and provides suggestions for future interventions.",2020,"The findings demonstrated that the intervention was effective in improving correct knowledge about gambling, reducing misconceptions and attitudes, and in decreasing the total hours spent gambling per week.","['High-School Students', '111 Portuguese high-school students']","['Gambling Prevention Program', 'integrative intervention']","['number of at-risk/problem gamblers', 'correct knowledge about gambling, reducing misconceptions and attitudes']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0032730', 'cui_str': 'Portuguese (ethnic group)'}]","[{'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.018052,"The findings demonstrated that the intervention was effective in improving correct knowledge about gambling, reducing misconceptions and attitudes, and in decreasing the total hours spent gambling per week.","[{'ForeName': 'Filipa', 'Initials': 'F', 'LastName': 'Calado', 'Affiliation': 'Department of Psychology, Nottingham Trent University, 50 Shakespeare Street, Nottingham, NG1 4FQ, UK. filipa.calado2013@my.ntu.ac.uk.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Alexandre', 'Affiliation': 'Department of Psychology, ISCTE - CIS/IUL - Lisbon University Institute, Avenida das Forças Armadas, 1649-026, Lisbon, Portugal.'}, {'ForeName': 'Liah', 'Initials': 'L', 'LastName': 'Rosenfeld', 'Affiliation': 'Department of Psychology, ISCTE - CIS/IUL - Lisbon University Institute, Avenida das Forças Armadas, 1649-026, Lisbon, Portugal.'}, {'ForeName': 'Rafaela', 'Initials': 'R', 'LastName': 'Pereira', 'Affiliation': 'Department of Psychology, ISCTE - CIS/IUL - Lisbon University Institute, Avenida das Forças Armadas, 1649-026, Lisbon, Portugal.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Griffiths', 'Affiliation': 'Department of Psychology, Nottingham Trent University, 50 Shakespeare Street, Nottingham, NG1 4FQ, UK.'}]",Journal of gambling studies,['10.1007/s10899-019-09908-2']
1177,30852136,"Reduced-dose combination chemotherapy (S-1 plus oxaliplatin) versus full-dose monotherapy (S-1) in older vulnerable patients with metastatic colorectal cancer (NORDIC9): a randomised, open-label phase 2 trial.","BACKGROUND


Older or vulnerable patients with metastatic colorectal cancer are seldom included in randomised trials. The multicentre NORDIC9 trial evaluated reduced-dose combination chemotherapy compared with full-dose monotherapy in older, vulnerable patients.
METHODS


This randomised, open-label phase 2 trial was done in 23 Nordic oncology clinics and included patients aged 70 years or older with previously untreated metastatic colorectal cancer who were not candidates for full-dose combination chemotherapy. Patients were block randomised (1:1) using a web-based tool to full-dose S-1 (30 mg/m 2  orally twice daily on days 1-14 every 3 weeks) followed by second-line treatment at progression with irinotecan (250 mg/m 2  intravenously on day 1 every 3 weeks or 180 mg/m 2  intravenously on day 1 every 2 weeks) or reduced-dose combination chemotherapy with S-1 (20 mg/m 2  orally twice daily on days 1-14) and oxaliplatin (100 mg/m 2  intravenously on day 1 every 3 weeks) followed by second-line treatment at progression with S-1 (20 mg/m 2  orally twice daily on days 1-14) and irinotecan (180 mg/m 2  intravenously on day 1 every 3 weeks). Use of bevacizumab (7·5 mg/kg intravenously on day 1 of each cycle) was optional. Treatment allocation was not masked and randomisation was stratified for institution and bevacizumab. The primary outcome was progression-free survival. Survival analyses were by intention to treat and safety analyses were done on the treated population. This trial is registered with EudraCT, number 2014-000394-39, and is closed to new participants.
FINDINGS


From March 9, 2015, to Oct 11, 2017, 160 patients with a median age of 78 years (IQR 76-81) were randomly assigned to full-dose monotherapy (n=83) or reduced-dose combination chemotherapy (n=77). At data cutoff (Sept 1, 2018; median follow-up 23·8 months [IQR 18·8-30·9]), 81 (98%) patients in the full-dose monotherapy group and 71 (92%) patients in the reduced-dose combination group had progressed or died. Median progression-free survival was significantly longer with reduced-dose combination chemotherapy (6·2 months [95% CI 5·3-8·3]) than with full-dose monotherapy (5·3 months [4·1-6·8]; hazard ratio [HR] 0·72 [95% CI 0·52-0·99]; p=0·047). Toxicity was evaluated in 157 patients who received treatment. Significantly more patients in the full-dose monotherapy group (51 [62%] of 82 patients) experienced at least one grade 3-4 adverse event than in the reduced-dose combination group (32 [43%] of 75 patients; p=0·014). Grade 3-4 diarrhoea (12 [15%] vs two [3%]; p=0·018), fatigue (ten [12%] vs three [4%]; p=0·083), and dehydration (five [6%] vs none; p=0·060) were more frequent in the full-dose monotherapy group than in the reduced-dose combination group. Treatment-related deaths occurred in three patients during first-line treatment and three patients during second-line treatment (two in the full-dose monotherapy group vs one in the reduced-dose combination group in both cases).
INTERPRETATION


Reduced-dose combination chemotherapy with S-1 and oxaliplatin for older, vulnerable patients with metastatic colorectal cancer was more effective and resulted in less toxicity than full-dose monotherapy with S-1. Reduced-dose combination chemotherapy could be a preferred treatment for this population.
FUNDING


Taiho Pharmaceuticals, Nordic Group, the Danish Cancer Society, the Swedish Cancer Society, Academy of Geriatric Research (AgeCare), and Region of Southern Denmark.",2019,Median progression-free survival was significantly longer with reduced-dose combination chemotherapy (6·2 months [95% CI 5·3-8·3]) than with full-dose monotherapy (5·3 months [4·1-6·8]; hazard ratio [HR] 0·72,"['older, vulnerable patients', '157 patients who received treatment', 'Older or vulnerable patients with metastatic colorectal cancer', 'older vulnerable patients with metastatic colorectal cancer (NORDIC9', 'older, vulnerable patients with metastatic colorectal cancer', '160 patients with a median age of 78 years', '23 Nordic oncology clinics and included patients aged 70 years or older with previously untreated metastatic colorectal cancer who were not candidates for full-dose combination chemotherapy']","['bevacizumab', 'S-1 and oxaliplatin', 'reduced-dose combination chemotherapy with S-1', 'monotherapy (n=83) or reduced-dose combination chemotherapy', 'full-dose monotherapy (S-1', 'oxaliplatin', 'irinotecan', 'combination chemotherapy', 'combination chemotherapy (S-1 plus oxaliplatin']","['fatigue', 'Grade 3-4 diarrhoea', 'dehydration', 'progressed or died', 'progression-free survival', 'toxicity', 'Toxicity', 'deaths', 'Median progression-free survival']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",160.0,0.341383,Median progression-free survival was significantly longer with reduced-dose combination chemotherapy (6·2 months [95% CI 5·3-8·3]) than with full-dose monotherapy (5·3 months [4·1-6·8]; hazard ratio [HR] 0·72,"[{'ForeName': 'Stine Braendegaard', 'Initials': 'SB', 'LastName': 'Winther', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark; Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Gabor', 'Initials': 'G', 'LastName': 'Liposits', 'Affiliation': 'Department of Oncology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Halla', 'Initials': 'H', 'LastName': 'Skuladottir', 'Affiliation': 'Department of Oncology, Regional Hospital West Jutland, Herning, Denmark.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hofsli', 'Affiliation': 'Department of Oncology, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Carl-Henrik', 'Initials': 'CH', 'LastName': 'Shah', 'Affiliation': 'Theme Cancer, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Laurids Østergaard', 'Initials': 'LØ', 'LastName': 'Poulsen', 'Affiliation': 'Department of Oncology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Ryg', 'Affiliation': 'Department of Geriatric Medicine, Odense University Hospital, Odense, Denmark; Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Osterlund', 'Affiliation': 'Department of Oncology, Tampere University Hospital, Tampere University, Tampere, Finland; Department of Oncology, Helsinki University Hospital, Helsinki University, Finland.'}, {'ForeName': 'Åke', 'Initials': 'Å', 'LastName': 'Berglund', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Qvortrup', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark; Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Glimelius', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Halfdan', 'Initials': 'H', 'LastName': 'Sorbye', 'Affiliation': 'Department of Oncology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Pfeiffer', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark; Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Odense, Denmark; OPEN, Odense Patient data Explorative Network, Odense University Hospital, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark. Electronic address: per.pfeiffer@rsyd.dk.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30041-X']
1178,32410952,Cerebellar Repetitive Transcranial Magnetic Stimulation and Noisy Galvanic Vestibular Stimulation Change Vestibulospinal Function.,"Background


The cerebellum strongly contributes to vestibulospinal function, and the modulation of vestibulospinal function is important for rehabilitation. As transcranial magnetic stimulation (TMS) and electrical stimulation may induce functional changes in neural systems, we investigated whether cerebellar repetitive TMS (crTMS) and noisy galvanic vestibular stimulation (nGVS) could modulate vestibulospinal response excitability. We also sought to determine whether crTMS could influence the effect of nGVS.
Methods


Fifty-nine healthy adults were recruited; 28 were randomly allocated to a real-crTMS group and 31 to a sham-crTMS group. The crTMS was conducted using 900 pulses at 1 Hz, while the participants were in a static position. After the crTMS, each participant was allocated to either a real-nGVS group or sham-nGVS group, and nGVS was delivered (15 min., 1 mA; 0.1-640 Hz) while patients were in a static position. The H-reflex ratio (with/without bilateral bipolar square wave pulse GVS), which reflects vestibulospinal excitability, was measured at pre-crTMS, post-crTMS, and post-nGVS.
Results


We found that crTMS alone and nGVS alone have no effect on H-reflex ratio but that the effect of nGVS was obtained after crTMS.
Conclusion


crTMS and nGVS appear to act as neuromodulators of vestibulospinal function.",2020,"After the crTMS, each participant was allocated to either a real-nGVS group or sham-nGVS group, and nGVS was delivered (15 min.",['Methods\n\n\nFifty-nine healthy adults were recruited; 28'],"['Cerebellar Repetitive Transcranial Magnetic Stimulation and Noisy Galvanic Vestibular Stimulation Change Vestibulospinal Function', 'real-crTMS group and 31 to a sham-crTMS', 'real-nGVS group or sham-nGVS group, and nGVS', 'cerebellar repetitive TMS (crTMS) and noisy galvanic vestibular stimulation (nGVS', 'transcranial magnetic stimulation (TMS) and electrical stimulation']",['H-reflex ratio'],"[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0018447', 'cui_str': 'H-reflex'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",59.0,0.112908,"After the crTMS, each participant was allocated to either a real-nGVS group or sham-nGVS group, and nGVS was delivered (15 min.","[{'ForeName': 'Akiyoshi', 'Initials': 'A', 'LastName': 'Matsugi', 'Affiliation': 'Faculty of Rehabilitation, Shijonawate Gakuen University, Daito, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Douchi', 'Affiliation': 'Department of Rehabilitation, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Rikiya', 'Initials': 'R', 'LastName': 'Hasada', 'Affiliation': 'Department of Rehabilitation, Nagahara Hospital, Higasiosaka, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Mori', 'Affiliation': 'Department of Neuromodulation and Neurosurgery, Graduate School of Medicine, Osaka University, Osaka, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'Faculty of Health Sciences, Kio University, Koryo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Yoshida', 'Affiliation': 'Institute of Rehabilitation Science, Tokuyukai Medical Corporation, Toyonaka, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Nishishita', 'Affiliation': 'Institute of Rehabilitation Science, Tokuyukai Medical Corporation, Toyonaka, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hosomi', 'Affiliation': 'Department of Neuromodulation and Neurosurgery, Graduate School of Medicine, Osaka University, Osaka, Japan.'}, {'ForeName': 'Youichi', 'Initials': 'Y', 'LastName': 'Saitoh', 'Affiliation': 'Department of Neuromodulation and Neurosurgery, Graduate School of Medicine, Osaka University, Osaka, Japan.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.00388']
1179,30444479,Transanal repair of rectocele with high frequency radio scalpel.,"AIM


This is a prospective randomized study to analyze results obtained in two groups of patients, affected by stage 2 rectocele and treated with rectum anterior wall repair and strength, performed with standard or modified Khubchandani technique, using High Frequency (HF) Radio Scalpel.
MATERIALS AND METHODS


A cohort of 24 patients with stage 2 rectocele (Mellgren's classification) have been included. Twelve (group A) underwent surgery with standard technique and twelve (group B) underwent surgery using the HF Radio Scalpel, which cuts and coagulates tissues without damage thanks to its low working temperature (45-70°C). Each patient underwent proctolo-gical examination and anoscopy in 7th, 15th, 45th POD and after 6 and 12 months.
RESULTS


During post-operative follow-up 5 patients from group A and 1 from group B didn't show up so that they drop out the study. As a result, group A is composed by 7 patients and group B by 11 patients. Mean operating time was significantly favourable in group B (51 vs 33 minutes, p< 0.01). The differences between other parameters weren't statistically significant, even if post-operative course was less difficult in HF Radio Scalpel group.
CONCLUSIONS


The surgical technique to repair and reinforce anterior rectal wall is easier and faster if performed with HF Radio Scalpel respect to the standard procedure described by Khubchandani. Post-operative course was less painful and, even more importantly considering the patient age, surgical time was shorter. Therefore, the results obtained cast positive light on using this technique to treat uncomplicated grade 2 rectocele.",2018,"Mean operating time was significantly favourable in group B (51 vs 33 minutes, p< 0.01).","[""24 patients with stage 2 rectocele (Mellgren's classification"", 'two groups of patients, affected by stage 2 rectocele and treated with']","['HF Radio Scalpel', 'Transanal repair of rectocele with high frequency radio scalpel', 'rectum anterior wall repair and strength, performed with standard or modified Khubchandani technique, using High Frequency (HF) Radio Scalpel', 'surgery with standard technique and twelve (group B) underwent surgery using the HF Radio Scalpel, which cuts and coagulates tissues without damage thanks to its low working temperature']",['Mean operating time'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0149771', 'cui_str': 'Proctocele'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0392220', 'cui_str': 'Surgical knife, device (physical object)'}, {'cui': 'C0589371', 'cui_str': 'Transanal approach (qualifier value)'}, {'cui': 'C0677487', 'cui_str': 'Repair of rectocele (procedure)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0034896', 'cui_str': 'Rectum'}, {'cui': 'C0442070', 'cui_str': 'Anterior wall (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",24.0,0.0266572,"Mean operating time was significantly favourable in group B (51 vs 33 minutes, p< 0.01).","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sforza', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Belardi', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pellicciaro', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Filingeri', 'Affiliation': ''}]",Il Giornale di chirurgia,[]
1180,31704549,Health-related quality of life in patients with fully resected BRAF V600  mutation-positive melanoma receiving adjuvant vemurafenib.,"AIM OF STUDY


The aim of the study was to assess the impact of treatment with adjuvant vemurafenib monotherapy on health-related quality of life (HRQOL) in patients with resected stage IIC-IIIC melanoma.
METHODS


The phase 3 BRIM8 study (NCT01667419) randomised patients with BRAF V600  mutation-positive resected stage IIC-IIIC melanoma to 960 mg of vemurafenib twice daily or matching placebo for 52 weeks (13 × 28-day cycles). Patients completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3 at baseline, cycle 1 (days 1, 15 and 22), cycle 2 (days 1 and 15), day 1 of every subsequent 4-week cycle, the end-of-treatment visit and each visit during the follow-up period.
RESULTS


Completion rates for the EORTC QLQ-C30 questionnaire were high (>80%). There was a mean decline in the global health status (GHS)/quality of life (QOL) score of 17.4 (±22.9) and 17.3 (±24.1) points at days 15 and 22 of cycle 1, respectively, among vemurafenib-treated patients who recovered to approximately 10 points below baseline for the remainder of the treatment period. A similar trend was observed in all functional scales except for cognitive function (<10-point change from baseline at all visits) and in the symptom scores for appetite loss, fatigue and pain. As observed for the GHS/QOL score, all scores rapidly returned to baseline after completion of planned vemurafenib treatment or treatment discontinuation.
CONCLUSIONS


The schedule of HRQOL assessments allowed for an accurate and complete evaluation of the impact of acute treatment-related symptoms. Vemurafenib-treated patients experience clinically meaningful moderate worsening in some treatment- or disease-related symptoms and GHS/QOL that resolve over time.",2019,"A similar trend was observed in all functional scales except for cognitive function (<10-point change from baseline at all visits) and in the symptom scores for appetite loss, fatigue and pain.","['patients with resected stage IIC-IIIC melanoma', 'patients with BRAF V600  mutation-positive resected stage IIC-IIIC melanoma to 960\xa0mg of', 'patients with fully resected BRAF V600  mutation-positive melanoma receiving adjuvant']","['adjuvant vemurafenib monotherapy', 'vemurafenib', 'Vemurafenib', 'vemurafenib twice daily or matching placebo']","['appetite loss, fatigue and pain', 'Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version', 'cognitive function', 'global health status (GHS)/quality of life (QOL) score', 'GHS/QOL score', 'health-related quality of life (HRQOL', 'EORTC QLQ-C30 questionnaire', 'Health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457161', 'cui_str': 'Stage IIc'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4517908', 'cui_str': '960 (qualifier value)'}]","[{'cui': 'C3192263', 'cui_str': 'Vemurafenib'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",,0.376995,"A similar trend was observed in all functional scales except for cognitive function (<10-point change from baseline at all visits) and in the symptom scores for appetite loss, fatigue and pain.","[{'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Hufelandstr. 55, 45122, Essen, Germany; The German Cancer Consortium, Heidelberg, Germany. Electronic address: dirk.schadendorf@uk-essen.de.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Di Giacomo', 'Affiliation': 'Division of Medical Oncology and Immunotherapy, Center for Immuno-Oncology, University Hospital of Siena, Banchi di Sotto, 55, 53100, Siena, SI, Italy.'}, {'ForeName': 'Lev', 'Initials': 'L', 'LastName': 'Demidov', 'Affiliation': 'N. N. Blokhin Russian Cancer Research Center, Ministry of Health, Russian Academy of Medical Sciences, Kashirskoye Shosse 24, 115478, Moscow, Russian Federation.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Merelli', 'Affiliation': 'Department of Oncology and Haematology, Papa Giovanni XXIII Cancer Center Hospital, Centro Ospedaliero, 24129, Bergamo, BG, Italy.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Dnipropetrovsk State Medical Academy, Volodymyra Vernadskoho St, 9, Dnipropetrovsk, 49044, Ukraine.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Melanoma Unit, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori, IRCCS Fondazione Pascale, Via Mariano Semmola, 53, 80131, Napoli, NA, Italy.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Herbert', 'Affiliation': 'Bristol Haematology and Oncology Centre, Horfield Rd, Avon, Bristol, BS2 8ED, United Kingdom.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Mackiewicz', 'Affiliation': 'Department of Cancer Immunology, Poznan University for Medical Sciences, Med-POLONIA, Collegium Maius, Fredry 10, 61-701, Poznań, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Institute - Oncology Center, Wawelska 15 B, 00-001, Warsaw, Poland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Guminski', 'Affiliation': 'Melanoma Translational Research Group, Melanoma Institute Australia, 40 Rocklands Rd, Wollstonecraft NSW, 2065, New South Wales, Australia.'}, {'ForeName': 'Grant R', 'Initials': 'GR', 'LastName': 'Goodman', 'Affiliation': 'Genentech, Inc., 410 Allerton Ave, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Simmons', 'Affiliation': 'Genentech, Inc., 410 Allerton Ave, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Chenglin', 'Initials': 'C', 'LastName': 'Ye', 'Affiliation': 'Genentech, Inc., 410 Allerton Ave, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Hong', 'Affiliation': 'Genentech, Inc., 410 Allerton Ave, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Lewis', 'Affiliation': 'University of Colorado Comprehensive Cancer Center, 1665 Aurora Court Anschutz Cancer Pavilion, Aurora, CO 80045, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.09.019']
1181,32407148,DIABEO System Combining a Mobile App Software with and without Telemonitoring versus Standard Care: A Randomized Controlled Trial in Diabetic Patients Poorly Controlled with a Basal-Bolus Insulin Regimen.,"BACKGROUND


The DIABEO system (DS) is a telemedicine solution that combines a mobile app for patients with a web portal for health care providers. DS allows real-time monitoring of basal-bolus insulin therapy as well as therapeutic decision making integrating both basal and bolus dose calculation. Real-life studies have shown a very low rate of use of mobile health applications by patients. Therefore, we conducted a large randomized controlled trial study to investigate the efficacy of DS in conditions close to real-life (TELESAGE study).
METHODS


TELESAGE was a multicenter, randomized, open study with three parallel arms: arm 1 (standard care), arm 2 (DIABEO® alone) and arm 3 (DIABEO® + telemonitoring by trained nurses). The primary outcome assessed the reduction in HbA1c levels after a 12-month follow-up.
RESULTS


Six hundred sixty-five (665) patients were included in the study. Participants who used DIABEO® once or more times a day (DIABEO® users) showed a significant and meaningful reduction of HbA1c versus standard care after 12-months follow up: mean difference -0.41% for arm 2 - arm 1 (P=0.001) and -0.51% for arm 3 - arm 1 (P≤0.001). DIABEO® users included 25.1% of participants in arm 2 and 37.6% in arm 3. In the intention-to-treat population, HbA1c changes and incidence of hypoglycemia were comparable between arms.
CONCLUSIONS


A clinical and statistically significant reduction in HbA1c levels was found in those patients who used DIABEO® at least once a day.",2020,"CONCLUSIONS


A clinical and statistically significant reduction in HbA1c levels was found in those patients who used DIABEO® at least once a day.","['Six hundred sixty-five (665) patients were included in the study', 'patients with a web portal for health care providers', 'Diabetic Patients']",['Mobile App Software with and without Telemonitoring versus Standard Care'],"['HbA1c changes and incidence of hypoglycemia', 'reduction in HbA1c levels', 'HbA1c levels']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",665.0,0.181033,"CONCLUSIONS


A clinical and statistically significant reduction in HbA1c levels was found in those patients who used DIABEO® at least once a day.","[{'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Franc', 'Affiliation': 'Sud-Francilien Hospital, Department of Diabetes, Corbeil-Essonnes, France.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Hanaire', 'Affiliation': 'CHU Toulouse, Diabetology, TSA50032, Toulouse, France, 31059; hanaire.h@chu-toulouse.fr.'}, {'ForeName': 'Pierre Yves', 'Initials': 'PY', 'LastName': 'Benhamou', 'Affiliation': 'University Hospital Grenoble, Department of Diabetology, Pôle DigiDune, Grenoble, France; pybenhamou@chu-grenoble.fr.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Schaepelynck', 'Affiliation': 'Marseille University Hospital, Sainte Marguerite Hospital, Department of Nutrition-Endocrinology-Metabolic Disorders, Marseille, France; pauline.schaepelynck@ap-hm.fr.'}, {'ForeName': 'Bogdan', 'Initials': 'B', 'LastName': 'Catargi', 'Affiliation': 'University Hospital, Department of Endocrinology and Diabetes, Bordeaux, France; bogdan.catargi@chu-bordeaux.fr.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Farret', 'Affiliation': 'University Hospital, Department of Endocrinology, Diabetes, Nutrition, Montpellier, France; a-farret@chu-montpellier.fr.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Fontaine', 'Affiliation': 'University Hospital, Department of Diabetology, Lille, France; Pierre.FONTAINE@CHRU-LILLE.FR.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Guerci', 'Affiliation': 'University of Lorraine, Endocrinology-Diabetes Care Unit, Vandoeuvre Les Nancy, France; b.guerci@gmail.com.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Reznik', 'Affiliation': 'University of Caen Côte de Nacre Regional Hospital Center, Department of Endocrinology, Caen , France; reznik-y@chu-caen.fr.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Jeandidier', 'Affiliation': 'University Hospital, Department of Endocrinology-Diabetes and Nutrition, Strasbourg, France; nathalie.jeandidier@chru-strasbourg.fr.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Penfornis', 'Affiliation': 'Universite Paris-Sud, 27048, Endocrinology, Orsay, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Borot', 'Affiliation': 'University Hospital Jean Minjoz, Department of Endocrinology-Metabolism and Diabetology-Nutrition, Besancon, France; sophie.borot@univ-fcomte.fr.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Chaillous', 'Affiliation': 'University Hospital (Institut du Thorax), Department of Diabetology, Nantes, France; lucy.chaillous@chu-nantes.fr.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Serusclat', 'Affiliation': 'Groupe Hospitalier Mutualiste Les Portes du Sud, Department of Endocrinology, Diabetology and Nutrition, Vénissieux, France; p.serusclat@lesportesdusud.fr.'}, {'ForeName': 'Yacine', 'Initials': 'Y', 'LastName': 'Kherbachi', 'Affiliation': 'Sanofi-Diabetes, Gentilly, France; ElYacine.KHERBACHI@sanofi.com.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': ""d'Orsay"", 'Affiliation': 'Voluntis, Suresnes, France; genevieve.dorsay@voluntis.com.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Detournay', 'Affiliation': 'CEMKA-EVAL, 55352, Bourg-La-Reine, France; bruno.detournay@cemka.fr.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Simon', 'Affiliation': 'National Association of Telemedicine, Evry, France; pierresimon491@yahoo.fr.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Charpentier', 'Affiliation': 'CERITD, Evry, France; kerbonac@free.fr.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0021']
1182,32407239,Effects of histamine-receptor antagonism on leg blood flow during exercise.,"Histamine mediates vasodilation during inflammatory and immune responses as well as following endurance exercise. During exercise, intramuscular histamine concentration increases and its production appears related to exercise intensity and duration. However, whether histamine contributes to exercise hyperemia and promotes exercise blood flow in an intensity or duration dependent pattern is unknown. The purpose of this study was to compare leg blood flow across a range of exercise intensities, before and after prolonged exercise, with and without histamine-receptor antagonism. It was hypothesized that combined oral histamine H 1 /H 2 -receptor antagonism would decrease leg blood flow and the effect would be greater at higher intensities and following prolonged exercise. Sixteen (7F, 9M) volunteers performed single-leg knee-extension exercise after consuming either Placebo or combined histamine H 1 /H 2 -receptor antagonists (Blockade). Exercise consisted of two graded protocols at 20, 40, 60, and 80% of peak power, separated by 60 min of knee-extension exercise at 60% of peak power. Femoral artery blood flow was measured by ultrasonography. Femoral artery blood flow increased with exercise intensity up to 2660±97 ml·min -1  at 80% of peak power during Placebo (P<0.05). Blood flow was further elevated with Blockade to 2836±124 ml·min -1  (P<0.05) at 80% peak power (9.1 ± 4.8% higher than Placebo). These patterns were not affected by prolonged exercise (P=0.13). On average, femoral blood flow during prolonged exercise was 12.7± 2.8% higher with Blockade versus Placebo (P<0.05). Contrary to the hypothesis, these results suggest that histamine-receptor antagonism during exercise, regardless of intensity or duration, increases leg blood flow measured by ultrasonography.",2020,Blood flow was further elevated with Blockade to 2836±124 ml·min -1  (P<0.05) at 80% peak power (9.1 ± 4.8% higher than Placebo).,[],"['Placebo', 'single-leg knee-extension exercise after consuming either Placebo or combined histamine H 1 /H 2 -receptor antagonists (Blockade', 'histamine-receptor antagonism', 'histamine', 'Histamine']","['leg blood flow', 'Blood flow', 'Femoral artery blood flow', 'femoral blood flow']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0034813', 'cui_str': 'Histamine receptor'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]",,0.0688832,Blood flow was further elevated with Blockade to 2836±124 ml·min -1  (P<0.05) at 80% peak power (9.1 ± 4.8% higher than Placebo).,"[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Ely', 'Affiliation': 'Department of Human Physiology, University of Oregon, United States.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Ratchford', 'Affiliation': 'University of Utah, United States.'}, {'ForeName': 'D Taylor', 'Initials': 'DT', 'LastName': 'La Salle', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, United States.'}, {'ForeName': 'Joel D', 'Initials': 'JD', 'LastName': 'Trinity', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Utah, United States.'}, {'ForeName': 'D Walter', 'Initials': 'DW', 'LastName': 'Wray', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Utah, United States.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Halliwill', 'Affiliation': 'Department of Human Physiology, University of Oregon, United States.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00689.2019']
1183,32407170,Effect of nostalgia as a motivational force for depressed students to seek professional psychological help.,"In times of distress, people show a tendency to remember the 'good old days,' a bittersweet emotion called Nostalgia. This study explores how experimentally-induced nostalgia improves attitude toward counseling center and behavioral intentions to contact the counseling center on a college campus. Students living with depression ( N  = 148) were randomly assigned to view a public service announcement (PSA) for the campus counseling center that was designed with or without a nostalgia-inducing narrative and imagery. Participants exposed to the nostalgic PSA expressed significantly higher positive emotions compared to the control condition, after controlling for the effects of stigma, past counseling experience, levels of depression, and friends or family with mental illness. Mediation analyses showed that the higher positive emotions participants felt, the more positive was their attitude toward the campus counseling center, which in turn increased behavioral intention to seek help. The study suggests nostalgia-themed messages to promote help-seeking intentions among students experiencing depression.",2020,"Participants exposed to the nostalgic PSA expressed significantly higher positive emotions compared to the control condition, after controlling for the effects of stigma, past counseling experience, levels of depression, and friends or family with mental illness.","['depressed students to seek professional psychological help', 'Students living with depression ( N \u2009=\u2009148', 'students experiencing depression']","['nostalgia', 'public service announcement (PSA) for the campus counseling center that was designed with or without a nostalgia-inducing narrative and imagery']","['effects of stigma, past counseling experience, levels of depression, and friends or family with mental illness', 'positive emotions']","[{'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0687688', 'cui_str': 'Public Service Announcements'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",148.0,0.0201216,"Participants exposed to the nostalgic PSA expressed significantly higher positive emotions compared to the control condition, after controlling for the effects of stigma, past counseling experience, levels of depression, and friends or family with mental illness.","[{'ForeName': 'Syed Ali', 'Initials': 'SA', 'LastName': 'Hussain', 'Affiliation': 'Walter Cronkite School of Journalism and Mass Communication, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Saleem', 'Initials': 'S', 'LastName': 'Alhabash', 'Affiliation': 'Department of Advertising\u2009+\u2009Public Relations, Michigan State University, East Lansing, MI, USA.'}]",Journal of American college health : J of ACH,['10.1080/07448481.2020.1754838']
1184,32407216,Randomized Phase III Study of Pemetrexed Plus Cisplatin Versus Vinorelbine Plus Cisplatin for Completely Resected Stage II to IIIA Nonsquamous Non-Small-Cell Lung Cancer.,"PURPOSE


To evaluate the efficacy of pemetrexed plus cisplatin versus vinorelbine plus cisplatin as postoperative adjuvant chemotherapy in patients with pathologic stage II-IIIA nonsquamous non-small-cell lung cancer (NSCLC).
PATIENTS AND METHODS


We performed a randomized, open-label, phase III study at 50 institutions within 7 clinical study groups in Japan. Patients with completely resected pathologic stage II-IIIA (TNM 7th edition) nonsquamous NSCLC were randomly assigned to receive either pemetrexed (500 mg/m 2 , day 1) plus cisplatin (75 mg/m 2 , day 1) or vinorelbine (25 mg/m 2 , days 1 and 8) plus cisplatin (80 mg/m 2 , day 1) with stratification by sex, age, pathologic stage,  EGFR  mutation, and institution. These treatments were planned to be given every 3 weeks for 4 cycles. The primary end point was recurrence-free survival in the modified intent-to-treat population, excluding ineligible patients.
RESULT


Between March 2012 and August 2016, 804 patients were enrolled (402 assigned to vinorelbine plus cisplatin and 402 assigned to pemetrexed plus cisplatin). Of 784 eligible patients, 410 (52%) had stage IIIA disease and 192 (24%) had  EGFR -sensitive mutations. At a median follow-up of 45.2 months, median recurrence-free survival was 37.3 months for vinorelbine plus cisplatin and 38.9 months for pemetrexed plus cisplatin, with a hazard ratio of 0.98 (95% CI, 0.81 to 1.20; 1-sided  P  = .474). Grade 3-4 toxicities reported more frequently for vinorelbine plus cisplatin than for pemetrexed plus cisplatin were febrile neutropenia (11.6%  v  0.3%, respectively), neutropenia (81.1%  v  22.7%, respectively), and anemia (9.3%  v  2.8%, respectively). One treatment-related death occurred in each arm.
CONCLUSION


Although this study failed to show the superiority of pemetrexed plus cisplatin for patients with resected nonsquamous NSCLC, this regimen showed a better tolerability as adjuvant chemotherapy.",2020,"Grade 3-4 toxicities reported more frequently for vinorelbine plus cisplatin than for pemetrexed plus cisplatin were febrile neutropenia (11.6%  v  0.3%, respectively), neutropenia (81.1%  v  22.7%, respectively), and anemia (9.3%  v  2.8%, respectively).","['nonsquamous NSCLC', 'patients with pathologic stage II-IIIA nonsquamous non-small-cell lung cancer (NSCLC', 'We performed a randomized, open-label, phase III study at 50 institutions within 7 clinical study groups in Japan', '784 eligible patients, 410 (52%) had stage IIIA disease and 192 (24%) had  EGFR -sensitive mutations', 'Completely Resected Stage II to IIIA Nonsquamous Non-Small-Cell Lung Cancer', 'Between March 2012 and August 2016, 804 patients were enrolled (402 assigned to', 'patients with resected nonsquamous NSCLC', 'Patients with completely resected pathologic stage II-IIIA (TNM 7th edition']","['vinorelbine', 'Pemetrexed Plus Cisplatin Versus Vinorelbine Plus Cisplatin', 'cisplatin', 'vinorelbine plus cisplatin', 'pemetrexed plus cisplatin', 'vinorelbine plus cisplatin and 402 assigned to pemetrexed plus cisplatin', 'pemetrexed']","['febrile neutropenia', 'neutropenia', 'death', 'anemia', 'recurrence-free survival', 'Grade 3-4 toxicities', 'median recurrence-free survival']","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1320480', 'cui_str': 'Pathologic stage'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0039694', 'cui_str': 'Tetranitromethane'}, {'cui': 'C0441792', 'cui_str': 'Editions'}]","[{'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",804.0,0.219795,"Grade 3-4 toxicities reported more frequently for vinorelbine plus cisplatin than for pemetrexed plus cisplatin were febrile neutropenia (11.6%  v  0.3%, respectively), neutropenia (81.1%  v  22.7%, respectively), and anemia (9.3%  v  2.8%, respectively).","[{'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Kenmotsu', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi-cho Sunto-gun, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Katsuo', 'Initials': 'K', 'LastName': 'Yoshiya', 'Affiliation': 'Department of Chest Surgery, Niigata Cancer Center Hospital, Niigata, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi-cho Sunto-gun, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Ueno', 'Affiliation': 'Department of Thoracic Surgery, National Hospital Organization, Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Goto', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Daga', 'Affiliation': 'Department of Medical Oncology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Norihiko', 'Initials': 'N', 'LastName': 'Ikeda', 'Affiliation': 'Department of Surgery, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Sugio', 'Affiliation': 'Department of Thoracic and Breast Surgery, Oita University, Oita, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Seto', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Toyooka', 'Affiliation': 'Department of General Thoracic Surgery, Breast and Endocrinological Surgery, Okayama University, Okayama, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Date', 'Affiliation': 'Department of Thoracic Surgery, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Mitsudomi', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.'}, {'ForeName': 'Isamu', 'Initials': 'I', 'LastName': 'Okamoto', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Yokoi', 'Affiliation': 'Department of Thoracic Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Saka', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Okamoto', 'Affiliation': ""Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.""}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Takiguchi', 'Affiliation': 'Department of Medical Oncology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Tsuboi', 'Affiliation': 'Division of Thoracic Surgery, National Cancer Center Hospital East, Kashiwa, Japan.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02674']
1185,30932951,Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials.,"OBJECTIVE


Compared with tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF) has been associated with improvement in markers of renal dysfunction in individual randomized trials; however, the comparative incidence of clinically significant renal events remains unclear.
DESIGN


We used a pooled data approach to increase the person-years of drug exposure analysed, maximizing our ability to detect differences in clinically significant outcomes.
METHODS


We pooled clinical renal safety data across 26 treatment-naive and antiretroviral switch studies to compare the incidence of proximal renal tubulopathy and discontinuation due to renal adverse events between participants taking TAF-containing regimens vs. those taking TDF-containing regimens. We performed secondary analyses from seven large randomized studies (two treatment-naive and five switch studies) to compare incidence of renal adverse events, treatment-emergent proteinuria, changes in serum creatinine, creatinine clearance, and urinary biomarkers (albumin, beta-2-microglobulin, and retinol binding protein-to-creatinine ratios).
RESULTS


Our integrated analysis included 9322 adults and children with HIV (n = 6360 TAF, n = 2962 TDF) with exposure of 12 519 person-years to TAF and 5947 to TDF. There were no cases of proximal renal tubulopathy in participants receiving TAF vs. 10 cases in those receiving TDF (P < 0.001), and fewer individuals on TAF (3/6360) vs. TDF (14/2962) (P < 0.001) discontinued due to a renal adverse event. Participants initiating TAF-based vs. TDF-based regimens had more favourable changes in renal biomarkers through 96 weeks of therapy.
CONCLUSION


These pooled data from 26 studies, with over 12 500 person-years of follow-up in children and adults, support the comparative renal safety of TAF over TDF.",2019,"Participants initiating TAF-based vs. TDF-based regimens had more favourable changes in renal biomarkers through 96 weeks of therapy.
","['participants taking TAF-containing regimens vs. those taking TDF-containing regimens', '9322 adults and children with HIV (n\u200a=\u200a6360 TAF, n\u200a=\u200a2962 TDF) with exposure of 12\u200a519 person-years to TAF and 5947 to TDF']","['tenofovir alafenamide vs. tenofovir disoproxil fumarate', 'tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF']","['Renal safety', 'proximal renal tubulopathy', 'renal adverse events, treatment-emergent proteinuria, changes in serum creatinine, creatinine clearance, and urinary biomarkers (albumin, beta-2-microglobulin, and retinol binding protein-to-creatinine ratios', 'renal biomarkers']","[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0201910', 'cui_str': 'Beta-2-microglobulin measurement (procedure)'}, {'cui': 'C1446172', 'cui_str': 'Retinol binding protein measurement (procedure)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",9322.0,0.10091,"Participants initiating TAF-based vs. TDF-based regimens had more favourable changes in renal biomarkers through 96 weeks of therapy.
","[{'ForeName': 'Samir K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Post', 'Affiliation': ""King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'José R', 'Initials': 'JR', 'LastName': 'Arribas', 'Affiliation': 'Instituto de Investigación Hospital Universitario La Paz, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Eron', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, UNC School of Medicine.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Wohl', 'Affiliation': 'Division of Infectious Diseases, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Amanda E', 'Initials': 'AE', 'LastName': 'Clarke', 'Affiliation': 'Sexual Health and Clinical Trials, Royal Sussex County Hospital, Brighton, UK.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Sax', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Hans-Jürgen', 'Initials': 'HJ', 'LastName': 'Stellbrink', 'Affiliation': 'Infectious Disease Medical Center, Hamburg.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Esser', 'Affiliation': 'Universitatsklinikum, Essen, Germany.'}, {'ForeName': 'Anton L', 'Initials': 'AL', 'LastName': 'Pozniak', 'Affiliation': 'Chelsea and Westminster Hospital and St Stephens AIDS Trust, London, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Podzamczer', 'Affiliation': 'Infectious Diseases Service, Hospital Universitario de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Waters', 'Affiliation': 'Mortimer Market Centre.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Orkin', 'Affiliation': 'Barts Health NHS Trust, Ambrose King Centre, Royal London Hospital, London, UK.'}, {'ForeName': 'Jürgen K', 'Initials': 'JK', 'LastName': 'Rockstroh', 'Affiliation': 'University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Mudrikova', 'Affiliation': 'Department of Internal Medicine and Infectious Diseases, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Negredo', 'Affiliation': 'Universitat de Vic-Universitat Central de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Elion', 'Affiliation': 'Department of Clinical Investigations, Whitman-Walker Health, Washington, District of Columbia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': 'Departments of Biometrics and HIV & Emerging Viral Infections Clinical Research, Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Lijie', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'Departments of Biometrics and HIV & Emerging Viral Infections Clinical Research, Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Carter', 'Affiliation': 'Departments of Biometrics and HIV & Emerging Viral Infections Clinical Research, Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Hal', 'Initials': 'H', 'LastName': 'Martin', 'Affiliation': 'Departments of Biometrics and HIV & Emerging Viral Infections Clinical Research, Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Brainard', 'Affiliation': 'Departments of Biometrics and HIV & Emerging Viral Infections Clinical Research, Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Devi', 'Initials': 'D', 'LastName': 'SenGupta', 'Affiliation': 'Departments of Biometrics and HIV & Emerging Viral Infections Clinical Research, Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Moupali', 'Initials': 'M', 'LastName': 'Das', 'Affiliation': 'Departments of Biometrics and HIV & Emerging Viral Infections Clinical Research, Gilead Sciences, Inc., Foster City, California, USA.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002223']
1186,30926276,"A prospective, single-blind, randomized, phase III study to evaluate the safety and efficacy of Fibrin Sealant Grifols as an adjunct to hemostasis compared with manual compression in vascular surgery.","OBJECTIVE


New formulations and applications of hemostatic adjuncts such as fibrin sealant (FS) to support local hemostasis and sutures continue to be developed. In a pivotal, confirmatory, controlled, prospective, single-blinded, randomized, multicenter phase III clinical trial, the efficacy and safety of FS Grifols during vascular surgeries were evaluated.
METHODS


Patients undergoing a nonemergency, open, peripheral vascular surgical procedure with moderate arterial bleeding were recruited. In an initial preliminary part of the study, all patients were treated with FS Grifols. In a subsequent primary part, patients were randomized (2:1) to FS Grifols or manual compression (MC). The primary efficacy end point was the proportion of the primary part patients achieving hemostasis by 4 minutes after the start of treatment. Cumulative proportion and time to hemostasis were secondary efficacy end points. Safety end points (in pooled preliminary and primary parts) included adverse events (AEs), vital signs, physical assessments, clinical laboratory tests, viral markers, and immunogenicity.
RESULTS


The primary efficacy end point was met by 76.1% of patients (83/109) for the FS Grifols group versus 22.8% of patients (13/57) for the MC group (P < .001). The cumulative proportion of patients at 5, 7, and 10 minutes was 80.7%, 84.4%, and 88.1%, respectively, in the FS Grifols treatment group, and 28.1%, 35.1%, and 45.6% in the MC treatment group (P < .001). The median time to hemostasis was shorter in the FS Grifols group (4 minutes vs ≥10 minutes in the MC group; P < .001). The nature of AEs reported were those expected in the study patient profile. The percentage of patients experiencing treatment-emergent AEs were similar in both the FS Grifols (pooled n = 59 + 109) and MC groups (81.0% and 77.2%, respectively), most recurrent being procedural pain (34.5% and 36.8%, respectively) and pyrexia (11.3% and 10.5%, respectively).
CONCLUSIONS


FS Grifols was superior in efficacy and similar in safety to MC as an adjunct local hemostatic agent in patients undergoing open vascular surgeries.",2019,The median time to hemostasis was shorter in the FS Grifols group (4 minutes vs ≥10 minutes in the MC group; P < .001).,"['Patients undergoing a nonemergency, open, peripheral vascular surgical procedure with moderate arterial bleeding were recruited', 'patients undergoing open vascular surgeries']","['fibrin sealant (FS', 'Fibrin Sealant Grifols', 'FS Grifols or manual compression (MC']","['pyrexia', 'safety and efficacy', 'cumulative proportion', 'percentage of patients experiencing treatment-emergent AEs', 'recurrent being procedural pain', 'Cumulative proportion and time to hemostasis', 'adverse events (AEs), vital signs, physical assessments, clinical laboratory tests, viral markers, and immunogenicity', 'proportion of the primary part patients achieving hemostasis', 'median time to hemostasis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0042381', 'cui_str': 'Vascular Surgical Procedures'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0340654', 'cui_str': 'Arterial bleed'}, {'cui': 'C3714645', 'cui_str': 'Vascular surgery'}]","[{'cui': 'C0016004', 'cui_str': 'Fibrin Glue'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}]","[{'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1619712', 'cui_str': 'Pain, Procedural'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518766'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}, {'cui': 'C0162492', 'cui_str': 'Viral Markers'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.0815489,The median time to hemostasis was shorter in the FS Grifols group (4 minutes vs ≥10 minutes in the MC group; P < .001).,"[{'ForeName': 'Dragoslav', 'Initials': 'D', 'LastName': 'Nenezić', 'Affiliation': 'Institute for Cardiovascular Diseases ""Dedinje"", Clinic for Vascular Surgery, Belgrade, Serbia. Electronic address: neneza55@gmail.com.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Ayguasanosa', 'Affiliation': 'Grifols Bioscience Research Group, Grifols, Barcelona, Spain.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Menyhei', 'Affiliation': 'Department of Vascular Surgery, Pecs University Clinical Center, Pecs, Hungary.'}, {'ForeName': 'Holjencsik', 'Initials': 'H', 'LastName': 'Tamás', 'Affiliation': 'Department of Vascular Surgery, Csolnoky Ferenc County Hospital, Veszprem, Hungary.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Mátyás', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Borsod Teaching County Hospital Miskolc, Borsod, Hungary.'}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Muluk', 'Affiliation': 'Division of Vascular Surgery, Allegheny General Hospital, Pittsburgh, Pa.'}, {'ForeName': 'Kecia', 'Initials': 'K', 'LastName': 'Courtney', 'Affiliation': 'Grifols Bioscience Research Group, Grifols, Barcelona, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Ibáñez', 'Affiliation': 'Grifols Bioscience Research Group, Grifols, Barcelona, Spain.'}, {'ForeName': 'Junliang', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Grifols Bioscience Research Group, Grifols, Barcelona, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of vascular surgery,['10.1016/j.jvs.2018.12.051']
1187,30922873,Long-term efficacy and safety of obeticholic acid for patients with primary biliary cholangitis: 3-year results of an international open-label extension study.,"BACKGROUND


The aim of this study was to evaluate the long-term efficacy and safety of obeticholic acid for patients with primary biliary cholangitis using 3-year interim data from the 5-year open-label extension of the pivotal phase 3 POISE trial.
METHODS


In the double-blind phase of POISE, 217 patients with primary biliary cholangitis with inadequate response to or intolerance to ursodeoxycholic acid were randomised to receive placebo, obeticholic acid 5 to 10 mg, or obeticholic acid 10 mg once daily for 12 months. During the open-label extension phase, patients received variable, adjusted doses of obeticholic acid. Markers of cholestasis and liver injury, alkaline phosphatase (ALP), and total and direct bilirubin were evaluated, and safety was assessed for up to 48 months of treatment with obeticholic acid. All analyses in the open-label extension were done in the safety population, defined as any patient randomised in the double-blind phase who received at least one dose of obeticholic acid during the open-label extension. This trial is registered at ClinicalTrials.gov (NCT01473524) and with EudraCT (2011-004728-36).
FINDINGS


193 patients were treated during the open-label extension. In this 3-year interim analysis, ALP concentrations were significantly reduced compared with baseline at 12 months (mean change -105·2 U/L [SD 87·6]), 24 months (-101·0 U/L [98·5]), 36 months (-108·6 U/L [95·7]), and 48 months (-95·6 U/L [121·1]; p<0·0001 for all yearly time points). Total bilirubin concentrations were stabilised, with significant reductions versus baseline at 12 months (mean change -0·9 μmol/L [SD 4·1]; p=0·0042) and 48 months (-0·8 μmol/L [3·8]; p=0·016). Stabilisation was also noted for direct bilirubin, with a significant change from baseline at 12 months (mean change -0·5 μmol/L [SD 3·0]; p=0·021). However, changes in total and direct bilirubin were not significant at other time points. Obeticholic acid was generally well tolerated, with pruritus (149 [77%] patients) and fatigue (63 [33%]) being the most common adverse events. No serious adverse events were considered related to obeticholic acid.
INTERPRETATION


Interim analyses suggest long-term efficacy and safety of obeticholic acid in patients with primary biliary cholangitis who are intolerant to or inadequately responsive to ursodeoxycholic acid.
FUNDING


Intercept Pharmaceuticals.",2019,"Total bilirubin concentrations were stabilised, with significant reductions versus baseline at 12 months (mean change -0·9 μmol/L [SD 4·1]; p=0·0042) and 48 months (-0·8 μmol/L [3·8]; p=0·016).","['patients with primary biliary cholangitis', 'patients with primary biliary cholangitis using 3-year interim data from the 5-year open-label extension of the pivotal phase 3 POISE trial', 'patients with primary biliary cholangitis who are intolerant to or inadequately responsive to ursodeoxycholic acid', '217 patients with primary biliary cholangitis with inadequate response to or intolerance to', '193 patients were treated during the open-label extension']","['EudraCT', 'obeticholic acid', 'Obeticholic acid', 'placebo, obeticholic acid 5 to 10 mg, or obeticholic acid', 'ursodeoxycholic acid']","['fatigue', 'Total bilirubin concentrations', 'Markers of cholestasis and liver injury, alkaline phosphatase (ALP), and total and direct bilirubin', 'ALP concentrations', 'direct bilirubin', 'total and direct bilirubin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008312', 'cui_str': 'Primary Billiary Cholangitis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0042105', 'cui_str': 'ursodesoxycholic acid'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C1143018', 'cui_str': 'obeticholic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042105', 'cui_str': 'ursodesoxycholic acid'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0008370', 'cui_str': 'Bile Duct Obstruction'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver (disorder)'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0236556', 'cui_str': 'Direct reacting bilirubin (substance)'}]",217.0,0.383306,"Total bilirubin concentrations were stabilised, with significant reductions versus baseline at 12 months (mean change -0·9 μmol/L [SD 4·1]; p=0·0042) and 48 months (-0·8 μmol/L [3·8]; p=0·016).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Trauner', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Vienna, Vienna, Austria. Electronic address: michael.trauner@meduniwien.ac.at.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Nevens', 'Affiliation': 'University Hospital KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Mitchell L', 'Initials': 'ML', 'LastName': 'Shiffman', 'Affiliation': 'Bon Secours Liver Institute of Hampton Roads, Newport News, VA, USA.'}, {'ForeName': 'Joost P H', 'Initials': 'JPH', 'LastName': 'Drenth', 'Affiliation': 'Radboudumc, Nijmegen, Netherlands.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Bowlus', 'Affiliation': 'University of California, Davis, Sacramento, CA, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Vargas', 'Affiliation': ""Liver Unit, Hospital Vall d'Hebron, Universitat Autònoma de Barcelona, CIBERehd, Barcelona, Spain.""}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Andreone', 'Affiliation': 'Center for Research and Study of Hepatitis, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Gideon M', 'Initials': 'GM', 'LastName': 'Hirschfield', 'Affiliation': 'Centre for Liver Research, NIHR Birmingham Liver Biomedical Research Unit, Institute of Immunology and Immunotherapy, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pencek', 'Affiliation': 'Intercept Pharmaceuticals, New York, NY, USA.'}, {'ForeName': 'Elizabeth Smoot', 'Initials': 'ES', 'LastName': 'Malecha', 'Affiliation': 'Intercept Pharmaceuticals, New York, NY, USA.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'MacConell', 'Affiliation': 'Intercept Pharmaceuticals, New York, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shapiro', 'Affiliation': 'Intercept Pharmaceuticals, New York, NY, USA.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30094-9']
1188,30844795,Effects of L-Menthol and Carbon Dioxide on the Adenoma Detection Rate during Colonoscopy: L-Menthol and Carbon Dioxide on Colonoscopy.,"BACKGROUND AND AIMS


We examined the efficacy of the combined use of L-menthol spraying (L-mentholS) as an antispasmodic agent and carbon dioxide insufflation (CO2I) on the adenoma detection rate (ADR) in a prospective, single-center trial with a 2 × 2 factorial design.
METHODS


We randomly assigned 611 patients scheduled to undergo colonoscopy to 4 groups: (1) the L-mentholS + CO2I (n = 153), (2) L-mentholS + air insufflation (AI; n = 156), (3) CO2I (n = 153), and (4) AI (n = 149) groups. We used 20 mL of 0.8%-L-menthol solution for the L-mentholS. The primary outcome was the difference in the ADR, and the secondary outcomes were the differences in colonic peristalsis and abdominal pain. -Results: The ADRs were not different among the groups: 1/2/3/4; 39.9%/43.6%/41.2%/51.0%. CO2I was associated with a significant decrease in the ADR (OR 0.57; 95% CI 0.35- 0.93) with a multiple logistic regression. The interaction between L-mentholS and CO2I was associated with a suppression of the decrease in the ADR. Both L-mentholS and CO2I were associated with a significant decrease in abdominal pain, and L-mentholS was associated with a significant improvement of peristalsis.
CONCLUSIONS


The fact that CO2I was associated with significant decreases in the ADR was a problem. The combined use of L-mentholS and CO2I could help to suppress the decrease in the ADR.",2020,CO2I was associated with a significant decrease in the ADR (OR 0.57; 95% CI 0.35- 0.93) with a multiple logistic regression.,"['611 patients scheduled to', 'Results']","['0.8%-L-menthol solution for the L-mentholS', 'L-mentholS + air insufflation', 'carbon dioxide insufflation (CO2I', 'L-Menthol and Carbon Dioxide', 'L-menthol spraying (L-mentholS', 'Colonoscopy: L-Menthol and Carbon Dioxide', 'undergo colonoscopy to 4 groups: (1) the L-mentholS + CO2I']","['Adenoma Detection Rate', 'colonic peristalsis and abdominal pain', 'ADR', 'adenoma detection rate (ADR', 'CO2I', 'abdominal pain, and L-mentholS']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0771655', 'cui_str': 'LEVOMENTHOL'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0031133', 'cui_str': 'Peristalsis'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0449207', 'cui_str': 'ADR (body structure)'}, {'cui': 'C0771655', 'cui_str': 'LEVOMENTHOL'}]",611.0,0.054965,CO2I was associated with a significant decrease in the ADR (OR 0.57; 95% CI 0.35- 0.93) with a multiple logistic regression.,"[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Inoue', 'Affiliation': 'Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan, keninoue71@koto.kpu-m.ac.jp.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Okuda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Fukuchiyama City Hospital, Kyoto, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Oka', 'Affiliation': 'Department of Molecular Gastroenterology and Hepatology, North Medical Center Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Sugino', 'Affiliation': 'Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Endo', 'Affiliation': 'Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Ota', 'Affiliation': 'Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Minagawa', 'Affiliation': 'Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Yasue', 'Affiliation': 'Department of Gastroenterology, Cancer Institute Hospital of JFCR, Tokyo, Japan.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Tsuji', 'Affiliation': 'Department of Gastroenterology and Hepatology, Fukuchiyama City Hospital, Kyoto, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Katayama', 'Affiliation': 'Department of Gastroenterology and Hepatology, Saiseikai Suita Hospital, Suita, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Nakamura', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nishijin Hospital, Kyoto, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Nagata', 'Affiliation': 'Department of Surgical Pathology, Fukuchiyama City Hospital, Kyoto, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Komaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Fukuchiyama City Hospital, Kyoto, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Naito', 'Affiliation': 'Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Yoshito', 'Initials': 'Y', 'LastName': 'Itoh', 'Affiliation': 'Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Keizo', 'Initials': 'K', 'LastName': 'Kagawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Fukuchiyama City Hospital, Kyoto, Japan.'}]",Digestion,['10.1159/000498941']
1189,30899327,Utilizing a family-based economic strengthening intervention to improve mental health wellbeing among female adolescent orphans in Uganda.,"Background


It is estimated that almost 20% of the world's adolescents have experienced or are experiencing a mental health problem. Several factors have been associated with the onset of adolescent mental health disorders, including poverty, child abuse and violence, particularly among adolescent girls. This paper examines the effect of participating in a family-based economic strengthening intervention on the mental health well-being of female adolescent orphans impacted by HIV/AIDS in rural Uganda.
Methods


Data utilized in this study was from the Bridges to the Future Study (2011-2016), an economic empowerment intervention aimed at improving health outcomes of orphaned children. Adolescents were randomly assigned to either the control condition receiving bolstered standard of care services for orphaned adolescents; or one of two treatment conditions receiving bolstered standard of care as well as an economic empowerment intervention comprising of a child development account, a mentorship program and workshops on financial management and microenterprise development. Data was collected at baseline, 12- and 24-months post intervention initiation. Multilinear regression analyses were conducted to examine the impact of an economic empowerment intervention on mental health functioning of female participants over time. Mental health functioning was measured by: (1) the Child Depression Inventory; (2) Beck Hopelessness Scale; and (3) Tennessee Self Concept Scale.
Results


Analysis results show an improvement in mental health functioning over time among female participants receiving the intervention compared to their control counterparts. Specifically, compared to participants in the control condition, participants receiving the intervention reported a reduction in depressive symptoms from baseline to 12-months follow-up (b = - 1.262, 95% CI - 2.476, - 0.047), and an additional 0.645-point reduction between baseline and 24-months follow-up (b = - 1.907, 95% CI - 3.192, - 0.622). Participants receiving the intervention reported significant improvement in their reported self-concept from baseline to 24 months follow-up (b = 3.503 (95% CI 1.469, 5.538) compared to participants in the control condition.
Conclusions


Empowerment of young girls, either in the form of peer mentorship and/or economic strengthening seems to significantly improve the overall mental health functioning of adolescent girls impacted by HIV and AIDS in low-income settings.",2019,"Results


Analysis results show an improvement in mental health functioning over time among female participants receiving the intervention compared to their control counterparts.","['female adolescent orphans impacted by HIV/AIDS in rural Uganda', 'female adolescent orphans in Uganda', 'adolescent girls', 'young girls', 'Adolescents', 'female participants over time']","['control condition receiving bolstered standard of care services for orphaned adolescents; or one of two treatment conditions receiving bolstered standard of care as well as an economic empowerment intervention comprising of a child development account, a mentorship program and workshops on financial management and microenterprise development', 'family-based economic strengthening intervention', 'Utilizing a family-based economic strengthening intervention', 'economic empowerment intervention']","['self-concept', 'depressive symptoms', 'mental health functioning', 'Child Depression Inventory; (2) Beck Hopelessness Scale; and (3) Tennessee Self Concept Scale', 'Mental health functioning', 'overall mental health functioning', 'mental health wellbeing']","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0242299', 'cui_str': 'Orphans'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0025370', 'cui_str': 'Mentorships'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0220830', 'cui_str': 'financial management'}, {'cui': 'C2936313', 'cui_str': 'Microenterprise'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0582612', 'cui_str': 'Beck hopelessness scale (assessment scale)'}, {'cui': 'C0039514', 'cui_str': 'Tennessee'}, {'cui': 'C0222045'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0445717,"Results


Analysis results show an improvement in mental health functioning over time among female participants receiving the intervention compared to their control counterparts.","[{'ForeName': 'Apollo', 'Initials': 'A', 'LastName': 'Kivumbi', 'Affiliation': 'International Center for Child Health and Development, P.O. Box 1988, Circular Rd, Masaka, Uganda.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Byansi', 'Affiliation': '3Brown School, Washington University in St. Louis, St. Louis, USA.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'International Center for Child Health and Development, P.O. Box 1988, Circular Rd, Masaka, Uganda.'}, {'ForeName': 'Nabunya', 'Initials': 'N', 'LastName': 'Proscovia', 'Affiliation': '2New York University Silver School of Social Work, New York, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Damulira', 'Affiliation': 'International Center for Child Health and Development, P.O. Box 1988, Circular Rd, Masaka, Uganda.'}, {'ForeName': 'Phionah', 'Initials': 'P', 'LastName': 'Namatovu', 'Affiliation': 'International Center for Child Health and Development, P.O. Box 1988, Circular Rd, Masaka, Uganda.'}]",Child and adolescent psychiatry and mental health,['10.1186/s13034-019-0273-4']
1190,28796940,Telephone-Based Depression Care Management for Postpartum Women: A Randomized Controlled Trial.,"OBJECTIVE


With a period prevalence of 21.9% in the year after birth, depression is a common complication of childbearing. We assessed the impact of telephone-delivered depression care management (DCM) on symptom levels, health service utilization, and functional status 3, 6, and 12 months postpartum.
METHODS


The randomized controlled trial was conducted at the University of Pittsburgh, Pittsburgh, Pennsylvania, from March 2006 through September 2010. Women (N = 628) who screened positive for depression (a score of 10 or greater on the Edinburgh Postnatal Depression Scale) 4 to 6 weeks postpartum were evaluated with the Structured Clinical Interview for DSM-IV-TR Axis I Disorders, Research Version, Patient Edition With Psychotic Screen and enrolled in a randomized trial of DCM compared to enhanced usual care (EUC). Clinicians conducted telephone contacts to educate, assist with treatment decisions, monitor symptoms, facilitate access to services, and encourage links to community resources. Independent evaluators collected symptom scores, functional status, and health services use at 3, 6, and 12 months postpartum. Primary outcome was reduction of symptoms as measured by the Structured Interview Guide for the Hamilton Depression Rating Scale with Atypical Depression Supplement.
RESULTS


Mean depressive symptom and function scores significantly improved (by greater than 50%) in both groups of women but did not differ by DCM versus EUC assignment. Health services use was similar in women randomly assigned to DCM compared to EUC. Women with childhood sexual abuse responded significantly more favorably to DCM on depression and functional measures (all P values < .02).
CONCLUSIONS


Both DCM and EUC favorably impacted depression symptom levels and function. The subgroup of women with childhood sexual abuse benefited significantly more from DCM compared to the EUC condition. Regular telephone availability of a clinician is a resource that appears to be particularly therapeutic to women with childhood sexual abuse.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT00282776.",2017,Mean depressive symptom and function scores significantly improved (by greater than 50%) in both groups of women but did not differ by DCM versus EUC assignment.,"['Women (N = 628) who screened positive for depression (a score of 10 or greater on the Edinburgh Postnatal Depression Scale) 4 to 6 weeks postpartum were evaluated with the Structured Clinical Interview for DSM-IV-TR Axis', 'women with childhood sexual abuse', 'Postpartum Women', 'Women with childhood sexual abuse', 'University of Pittsburgh, Pittsburgh, Pennsylvania, from March 2006 through September 2010']","['DCM', 'DCM and EUC', 'telephone-delivered depression care management (DCM', 'Telephone-Based Depression Care Management']","['reduction of symptoms as measured by the Structured Interview Guide for the Hamilton Depression Rating Scale with Atypical Depression Supplement', 'symptom scores, functional status, and health services use', 'Mean depressive symptom and function scores', 'depression and functional measures']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0199182', 'cui_str': 'Taking health history'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse (event)'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C4708576', 'cui_str': 'Depression care management'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.143457,Mean depressive symptom and function scores significantly improved (by greater than 50%) in both groups of women but did not differ by DCM versus EUC assignment.,"[{'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Wisner', 'Affiliation': '676 N St Clair St, Ste 1000, Chicago, IL 60611. katherine.wisner@northwestern.edu.'}, {'ForeName': 'Dorothy K Y', 'Initials': 'DKY', 'LastName': 'Sit', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'McShea', 'Affiliation': 'VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Luther', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Heather F', 'Initials': 'HF', 'LastName': 'Eng', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Dills', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Eydie L', 'Initials': 'EL', 'LastName': 'Moses-Kolko', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Wisniewski', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.15m10563']
1191,31821654,Randomised clinical trial of group-based physiotherapy in extremely low birthweight children with minimal/mild motor impairment: A preliminary study.,"AIM


Extremely low birthweight infants often present with mild neurodevelopmental impairments in gross motor function and postural stability in early childhood. The aim of the study was to undertake a randomised controlled trial to determine the short- and longer-term effects of group-based physiotherapy compared to standard care on performance in extremely low birthweight children with minimal/mild impairment.
METHODS


Fifty children aged 4 years, born <28 weeks gestation and/or birthweight <1000 g with minimal/mild motor impairment were enrolled in a randomised controlled trial and randomly allocated to 6 weeks of group-based intervention (n = 24) or standard care (n = 26). The intervention consisted of a combination of traditional physiotherapy and task-oriented approaches of approximately 1 h in duration and varied according to each child's strengths and weaknesses. Baseline, post intervention and 1 year post baseline assessments included Movement Assessment Battery for Children-2 (MABC-2), single leg stance, lateral reach and long jump.
RESULTS


Forty-eight (96%) children completed the study, which demonstrated no significant differences between the intervention and standard care groups on any of the assessments. Both groups improved initially from baseline to initial reassessment on the MABC-2 (P < 0.001). For both groups, however, MABC-2 manual dexterity, aiming/catching and total score declined from baseline to 1 year follow-up. However, for both groups, single leg stance and limb strength were significantly improved from baseline to 1 year follow-up.
CONCLUSIONS


There were no differences in outcomes between groups. Both approaches may contribute to improved short-term performance and longer-term improvements on functional skills in extremely preterm children.",2020,"However, for both groups, single leg stance and limb strength were significantly improved from baseline to 1 year follow-up.
","['Forty-eight (96', 'extremely low birthweight children with minimal/mild impairment', 'extremely preterm children', 'Fifty children aged 4\u2009years, born <28\u2009weeks gestation and/or birthweight <1000\u2009g with minimal/mild motor impairment', 'extremely low birthweight children with minimal/mild motor impairment']","['group-based physiotherapy', 'standard care']","['functional skills', 'single leg stance and limb strength', 'MABC-2 manual dexterity, aiming/catching and total score', 'MABC-2', 'Movement Assessment Battery for Children-2 (MABC-2), single leg stance, lateral reach and long jump']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}]",50.0,0.176483,"However, for both groups, single leg stance and limb strength were significantly improved from baseline to 1 year follow-up.
","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'Growth and Development Unit, Mater Health Services, Brisbane, Queensland, Australia.'}, {'ForeName': 'Yvonne R', 'Initials': 'YR', 'LastName': 'Burns', 'Affiliation': 'Growth and Development Unit, Mater Health Services, Brisbane, Queensland, Australia.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Watter', 'Affiliation': 'School of Health and Rehabilitation, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Kristen S', 'Initials': 'KS', 'LastName': 'Gibbons', 'Affiliation': 'Mater Research Institute, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Gray', 'Affiliation': 'Growth and Development Unit, Mater Health Services, Brisbane, Queensland, Australia.'}]",Journal of paediatrics and child health,['10.1111/jpc.14712']
1192,31821664,Randomised controlled trial: Shoulder-umbilicus length versus body weight measurement for optimal endotracheal tube depth estimation in ventilated infants.,"AIM


The optimal placement of the endotracheal tube (ETT) in ventilated infants is essential, but birthweight may be not the best parameter to predict it. The aim of this study was a direct comparison of shoulder-umbilical length (experimental group) versus birthweight (control group) as predictor of optimal ETT placement in Malaysian ventilated infants.
METHODS


All infants requiring ventilation in the neonatal intensive care unit of a tertiary hospital in Malaysia during the 4-month study period were eligible to enter this randomised controlled trial. All participants were randomised into two groups: experimental and control group. The main outcome measure was malposition of the ETT (requiring adjustment), as seen on the chest X-ray performed within 1 h after intubation. Tube placement was assessed by two neonatologists, blinded to the allocation.
RESULTS


One hundred and ten infants were randomised, 55 in each group. The ETT was malpositioned in 13 of 55 infants (23%) for the experimental group and 22 of 55 infants (40%) in the control group (P = 0.06).
CONCLUSION


In the experimental group, fewer infants showed a need for tube adjustment than in the control group. While a larger study may be necessary to show statistical significance, the difference shown in this study may be large enough to be of clinical significance.",2020,"In the experimental group, fewer infants showed a need for tube adjustment than in the control group.","['One hundred and ten infants', 'Malaysian ventilated infants', 'ventilated infants', 'All infants requiring ventilation in the neonatal intensive care unit of a tertiary hospital in Malaysia during the 4-month study period']","['Shoulder-umbilicus length versus body weight measurement', 'endotracheal tube (ETT', 'shoulder-umbilical length (experimental group) versus birthweight (control group']","['malposition of the ETT (requiring adjustment), as seen on the chest X-ray']","[{'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0041638', 'cui_str': 'Umbilicus'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0333042', 'cui_str': 'Malposition (morphologic abnormality)'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0039985', 'cui_str': 'Radiologic examination of chest'}]",110.0,0.123552,"In the experimental group, fewer infants showed a need for tube adjustment than in the control group.","[{'ForeName': 'Adam Al-Anas Bin', 'Initials': 'AAB', 'LastName': 'Mat Ali', 'Affiliation': 'Paediatric Department, Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, Kubang Kerian, Malaysia.'}, {'ForeName': 'Ariffin', 'Initials': 'A', 'LastName': 'Nasir', 'Affiliation': 'Paediatric Department, Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, Kubang Kerian, Malaysia.'}, {'ForeName': 'Noraida', 'Initials': 'N', 'LastName': 'Ramli', 'Affiliation': 'Paediatric Department, Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, Kubang Kerian, Malaysia.'}, {'ForeName': 'Nor R', 'Initials': 'NR', 'LastName': 'Ibrahim', 'Affiliation': 'Paediatric Department, Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, Kubang Kerian, Malaysia.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Van Rostenberghe', 'Affiliation': 'Paediatric Department, Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, Kubang Kerian, Malaysia.'}]",Journal of paediatrics and child health,['10.1111/jpc.14705']
1193,29088393,"Exercise, Manual Therapy, and Booster Sessions in Knee Osteoarthritis: Cost-Effectiveness Analysis From a Multicenter Randomized Controlled Trial.",,2018,,['Knee Osteoarthritis'],"['Exercise, Manual Therapy, and Booster Sessions']",[],"[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0454525', 'cui_str': 'Manual Therapies'}, {'cui': 'C1697762', 'cui_str': 'Booster'}]",[],,0.106947,,"[{'ForeName': 'Allyn M', 'Initials': 'AM', 'LastName': 'Bove', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh, 100 Technology Drive, Suite 210, Pittsburgh PA 15219.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Smith', 'Affiliation': 'Section of Decision Sciences, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Bise', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Fritz', 'Affiliation': 'Department of Physical Therapy, College of Health, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Childs', 'Affiliation': 'Evidence in Motion, San Antonio, and Doctoral Program in Physical Therapy, Baylor University, Waco, Texas.'}, {'ForeName': 'Gerard P', 'Initials': 'GP', 'LastName': 'Brennan', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, Utah.'}, {'ForeName': 'J Haxby', 'Initials': 'JH', 'LastName': 'Abbott', 'Affiliation': 'Centre for Musculoskeletal Outcomes Research, Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'G Kelley', 'Initials': 'GK', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh.'}]",Physical therapy,['10.1093/ptj/pzx104']
1194,32407179,"The synergic effects of alpha-lipoic acid supplementation and electrical isotonic contraction on anthropometric measurements and the serum levels of VEGF, NO, sirtuin-1, and PGC1-α in obese people undergoing a weight loss diet.","Background:  The anti-obesity effects of Alpha-lipoic acid (α-LA) and isotonic contraction has been reported. However, the underlying mechanism is not fully understood. This study aimed to investigate the effect of 1200 mg/day α-LA supplementation and 3 sessions per week of Faradic (an electrical stimulating system) on anthropometric parameters, body composition, VEGF, Sirtuin-1, nitric oxide (NO), and PGC1-α in obese people undergoing a weight loss regime. Methods:  This randomised clinical trial was carried out on 100 obese adults. The subjects were randomly assigned to four groups of 25 subjects including Faradic, α-LA, α-LA + Faradic, and control. A Bio Impedance Analyser (BIA) was used to estimate anthropometric measurements including weight, body mass index (BMI), fat mass, and fat free mass. The serum levels of Sirtuin-1, PGC1-α, VEGF, and NO levels were measured. All measurements were done at baseline and after 8 weeks of the intervention. Results:  A significant weight reduction was observed in all four groups compared to baseline ( p <.01). The placebo group had significantly higher weight, BMI, weight circumstance (WC), and body fat (BF) compared with the other groups. The α-LA + Faradic group had significantly lower weight, BMI, BF, WC than control, faradic, and α-LA groups and higher, Sirtuin and PGC than the control group (all  p  < .05). Conclusions:  The findings indicated that the α-LA and Faradic interventions may have a synergistic effect on weight, BMI, BF, WC, and SLM, possibly through changes in serum level of VEGF, NO, and PGC. Further studies are warranted to clarify the mutual effects of -α-LA and Faradic on obesity and its molecular mechanisms.  Name of the registry:  Iranian Registry of Clinical Trials Trial registration number:  IRCT20131117015424N2 Date of registration:  04/04/2018 URL of trial registry record:  https://www.irct.ir/search/result?query=IRCT20131117015424N2.",2020,"The placebo group had significantly higher weight, BMI, weight circumstance (WC), and body fat (BF) compared with the other groups.","['obese people undergoing a weight loss regime', '100 obese adults', 'obese people undergoing a weight loss diet']","['Alpha-lipoic acid (α-LA) and isotonic contraction', 'Faradic, α-LA, α-LA\u2009+\u2009Faradic, and control', 'alpha-lipoic acid supplementation and electrical isotonic contraction', '1200\u2009mg/day α-LA supplementation and 3 sessions per week of Faradic (an electrical stimulating system', 'placebo']","['weight, body mass index (BMI), fat mass, and fat free mass', 'anthropometric measurements and the serum levels of VEGF, NO, sirtuin-1, and PGC1-α', 'serum levels of Sirtuin-1, PGC1-α, VEGF, and NO levels', 'weight, BMI, BF, WC', 'anthropometric parameters, body composition, VEGF, Sirtuin-1, nitric oxide (NO), and PGC1-α', 'weight, BMI, weight circumstance (WC), and body fat (BF', 'weight, BMI, BF, WC, and SLM', 'weight reduction']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}]","[{'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0022259', 'cui_str': 'Muscle isotonic contraction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C2720167', 'cui_str': 'Sirt1'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",100.0,0.0456817,"The placebo group had significantly higher weight, BMI, weight circumstance (WC), and body fat (BF) compared with the other groups.","[{'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mohammadshahi', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical sciences, Ahvaz, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Zakizadeh', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical sciences, Ahvaz, Iran.'}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Ahmadi-Angali', 'Affiliation': 'Faculty of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ravanbakhsh', 'Affiliation': 'Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Helli', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical sciences, Ahvaz, Iran.'}]",Archives of physiology and biochemistry,['10.1080/13813455.2020.1762660']
1195,30938299,"Maternal pertussis vaccination and its effects on the immune response of infants aged up to 12 months in the Netherlands: an open-label, parallel, randomised controlled trial.","BACKGROUND


Maternal tetanus, diphtheria, and acellular pertussis (Tdap) vaccination offers protection for neonates against clinical pertussis until primary vaccinations, but maternal antibodies also interfere with infants' immune responses to primary vaccinations. We investigated the effect of maternal Tdap vaccination on the pertussis antibody responses of infants starting primary vaccinations at age 3 months.
METHODS


In an open-label, parallel, randomised, controlled trial, pregnant women aged 18-40 years with a low risk of pregnancy complications were recruited through independent midwives at 36 midwife clinics in the Netherlands and received Tdap vaccination either at 30-32 weeks of pregnancy (maternal Tdap group) or within 48 h after delivery (control group). All term-born infants were vaccinated with the diphtheria, tetanus, and pertussis-inactivated poliomyelitis-Haemophilus influenzae type B-hepatitis B six-in-one vaccine and a ten-valent pneumococcal vaccine at 3 months, 5 months, and 11 months. Randomisation was done using a number generator in a 1:1 ratio and with sealed envelopes. Participants and clinical trial staff were not masked, but laboratory technicians were unaware of study group assignments. The primary endpoint was serum IgG pertussis toxin antibody concentrations at age 3 months. Cord blood and infant blood samples were collected at age 2 months, 3 months, 6 months, 11 months, and 12 months. Analysis was done by modified intention to treat with all randomly assigned participants in case a laboratory result was available. This trial is registered with ClinicaltTrialsRegister.eu (EudraCT 2012-004006-9) and trialregister.nl (NTR number NTR4314). The trial is now closed to new participants.
FINDINGS


Between Jan 16, 2014, and March 4, 2016, 118 pregnant women were enrolled into our study, with 58 in the maternal Tdap group and 60 in the control group. The geometric mean concentration (GMC) of pertussis toxin antibodies were higher in infants in the maternal Tdap group than in the control group infants at age 3 months (GMC ratio 16·6, 95% CI 10·9-25·2) and also significantly higher compared with control infants at age 2 months. After primary vaccinations, antibody concentrations for pertussis toxin, filamentous haemagglutinin, and pertactin were significantly lower at all timepoints in infants of the maternal Tdap group than in infants in the control group. No safety issues after maternal Tdap vaccination were encountered.
INTERPRETATION


In view of the high pertussis toxin antibody concentrations at age 3 months, maternal vaccination supports a delay of the first pertussis vaccination in infants until at least age 3 months. Maternal antibody interference affects antibody concentrations after primary and booster vaccinations. The clinical consequences of this interference remain to be established.
FUNDING


The Dutch Ministry of Health, Welfare, and Sport.",2019,"After primary vaccinations, antibody concentrations for pertussis toxin, filamentous haemagglutinin, and pertactin were significantly lower at all timepoints in infants of the maternal Tdap group than in infants in the control group.","['118 pregnant women were enrolled into our study, with 58 in the maternal Tdap group and 60 in the control group', 'infants starting primary vaccinations at age 3 months', 'pregnant women aged 18-40 years with a low risk of pregnancy complications were recruited through independent midwives at 36 midwife clinics in the Netherlands and received', 'infants aged up to 12 months in the Netherlands', 'Between Jan 16, 2014, and March 4, 2016']","['maternal Tdap vaccination', 'diphtheria, and acellular pertussis (Tdap) vaccination', 'Tdap vaccination either at 30-32 weeks of pregnancy (maternal Tdap group) or within 48 h after delivery (control group', 'diphtheria, tetanus, and pertussis-inactivated poliomyelitis-Haemophilus influenzae type B-hepatitis B six-in-one vaccine and a ten-valent pneumococcal vaccine']","['Maternal antibody interference affects antibody concentrations', 'antibody concentrations for pertussis toxin, filamentous haemagglutinin, and pertactin', 'serum IgG pertussis toxin antibody concentrations', 'geometric mean concentration (GMC) of pertussis toxin antibodies', 'Cord blood and infant blood samples']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0032962', 'cui_str': 'Pregnancy Complications'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0026083', 'cui_str': 'Midwife'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0042203', 'cui_str': 'Pertussis vaccination (procedure)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C0121772', 'cui_str': 'Haemophilus influenzae type b'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0358314', 'cui_str': 'Pneumococcal vaccine (substance)'}]","[{'cui': 'C0729663', 'cui_str': 'Maternal antibody (substance)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0020731', 'cui_str': 'Histamine-Sensitizing Factor'}, {'cui': 'C0136166', 'cui_str': 'pertactin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",118.0,0.177939,"After primary vaccinations, antibody concentrations for pertussis toxin, filamentous haemagglutinin, and pertactin were significantly lower at all timepoints in infants of the maternal Tdap group than in infants in the control group.","[{'ForeName': 'Daan', 'Initials': 'D', 'LastName': 'Barug', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Pronk', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}, {'ForeName': 'Marlies A', 'Initials': 'MA', 'LastName': 'van Houten', 'Affiliation': 'Department of Paediatrics, Spaarne Hospital, Hoofddorp, Netherlands.'}, {'ForeName': 'Florens G A', 'Initials': 'FGA', 'LastName': 'Versteegh', 'Affiliation': ""University Groningen, University Medical Centre Groningen/Beatrix Children's Hospital, Groningen, Netherlands.""}, {'ForeName': 'Mirjam J', 'Initials': 'MJ', 'LastName': 'Knol', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'van de Kassteele', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}, {'ForeName': 'Guy A M', 'Initials': 'GAM', 'LastName': 'Berbers', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}, {'ForeName': 'Elisabeth A M', 'Initials': 'EAM', 'LastName': 'Sanders', 'Affiliation': ""Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands; Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, Utrecht, Netherlands.""}, {'ForeName': 'Nynke Y', 'Initials': 'NY', 'LastName': 'Rots', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands. Electronic address: nynke.rots@rivm.nl.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30717-5']
1196,30885505,"Feasibility and economic assessment of chromocolonoscopy for detection of proximal serrated neoplasia within a population-based colorectal cancer screening programme (CONSCOP): an open-label, randomised controlled non-inferiority trial.","BACKGROUND


Most post-colonoscopy interval colorectal cancers are proximal; serrated polyps are often precursors to these cancers and are considered difficult to detect. We assessed the safety, feasibility, and economic effect of chromocolonoscopy on detection of proximal serrated neoplasia.
METHODS


We did an open-label, multicentre, randomised, controlled non-inferiority trial including patients from Bowel Screening Wales centres. Participants who tested positive for faecal occult blood and who were eligible for and considered fit to have colonoscopy (patients with known cases of polyposis syndromes, Lynch syndrome, and chronic inflammatory disease were excluded) were randomly assigned (1:1; with the use of minimisation, stratified by centre with an 80:20 random element) to either standard white light colonoscopy (standard group) or chromocolonoscopy (indigo carmine dye [0·2%]; chromocolonoscopy group) using a secure, internet-based, computerised, randomisation system that used centralised, dynamic allocation. Participants were followed up for 1 year and data from index colonoscopies and associated clearance procedures were analysed. All proximal polyps were reviewed by an expert pathologist panel. The main outcome on which power was based was time taken to perform the colonoscopy procedure, defined as from the time when the scope was inserted to withdrawal from the anus, assessed in the per-protocol population. The non-inferiority margin was 15 min. This trial is complete and is registered with ClinicalTrials.gov, number NCT01972451.
FINDINGS


Between Nov 20, 2014, and June 16, 2016, 741 (72%) of 1031 patients screened were eligible and consented: 360 were randomly assigned to white light colonoscopy and 381 to chromocolonoscopy. In the chromocolonoscopy group, the procedure took a mean of 36·8 min (SD 15·0), compared with a mean of 30·6 min (13·7) in the standard group (mean difference 6·3 min [95% CI 4·2-8·4] longer with chromocolonoscopy than in the standard group). The mean difference was within the prespecified non-inferiority margin. Detection rates for proximal serrated lesions were significantly higher in the chromocolonoscopy group than in the control group (45 [12%] of 381 patients vs 23 [6%] of 360 patients; odds ratio 1·96 [95% CI 1·16-3·32]; p=0·012). Serious adverse events (four cases of postpolypectomy bleeding [two in each group], and one case of anxiety and hyperventilation [in the chromocolonoscopy group]), colonoscopy quality measures, comfort scores, and sedation were similar between groups.
INTERPRETATION


Chromocolonoscopy is feasible within a population-based colorectal cancer screening programme, is safe, and has significantly increased detection of proximal serrated neoplasia and other polyp types compared with standard colonoscopy. Larger randomised trials of chromocolonoscopy, powered for improved detection of significant serrated polyps and for longer-term follow-up to investigate the effect on reduction of interval cancers within screening populations, are warranted.
FUNDING


Health and Care Research Wales (RfPPB-1021).",2019,Detection rates for proximal serrated lesions were significantly higher in the chromocolonoscopy group than in the control group (45 [12%] of 381 patients vs 23 [6%] of 360 patients; odds ratio 1·96 [95% CI 1·16-3·32]; p=0·012).,"['Between Nov 20, 2014, and June 16, 2016, 741 (72%) of 1031 patients screened were eligible and consented: 360', 'Participants who tested positive for faecal occult blood and who were eligible for and considered fit to have colonoscopy (patients with known cases of polyposis syndromes, Lynch syndrome, and chronic inflammatory disease were excluded', 'patients from Bowel Screening Wales centres']","['white light colonoscopy', 'standard white light colonoscopy (standard group) or chromocolonoscopy (indigo carmine dye [0·2%]; chromocolonoscopy group) using a secure, internet-based, computerised, randomisation system that used centralised, dynamic allocation', 'chromocolonoscopy', 'colorectal cancer screening programme (CONSCOP']","['Serious adverse events', 'Detection rates for proximal serrated lesions', 'colonoscopy quality measures, comfort scores, and sedation', 'safety, feasibility, and economic effect']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces (procedure)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0334108', 'cui_str': 'Multiple polyps (morphologic abnormality)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C4552100', 'cui_str': 'Lynch Syndrome'}, {'cui': 'C1290886', 'cui_str': 'Chronic inflammatory disorder'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0563228', 'cui_str': 'White light (physical force)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0021219', 'cui_str': 'indigotindisulfonate sodium'}, {'cui': 'C0013343', 'cui_str': 'Dyes'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.28329,Detection rates for proximal serrated lesions were significantly higher in the chromocolonoscopy group than in the control group (45 [12%] of 381 patients vs 23 [6%] of 360 patients; odds ratio 1·96 [95% CI 1·16-3·32]; p=0·012).,"[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Hurt', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rajeswari', 'Initials': 'R', 'LastName': 'Ramaraj', 'Affiliation': 'Division of Population Medicine, Cardiff University School of Medicine, Cardiff, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Farr', 'Affiliation': 'College of Human and Health Sciences, Swansea Centre for Health Economics, Swansea University, Swansea, UK.'}, {'ForeName': 'Meleri', 'Initials': 'M', 'LastName': 'Morgan', 'Affiliation': 'Department of Pathology, Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Namor', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'Department of Pathology, Abertawe Bro Morgannwg University Health Board, Port Talbot, UK.'}, {'ForeName': 'Ceri J', 'Initials': 'CJ', 'LastName': 'Philips', 'Affiliation': 'College of Human and Health Sciences, Swansea Centre for Health Economics, Swansea University, Swansea, UK.'}, {'ForeName': 'Geraint T', 'Initials': 'GT', 'LastName': 'Williams', 'Affiliation': 'Department of Pathology, Cardiff University School of Medicine, Cardiff, UK.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Gardner', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Porter', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Sampson', 'Affiliation': 'Division of Cancer and Genetics, Department of Medical Genetics, Cardiff University School of Medicine, Cardiff, UK.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Hillier', 'Affiliation': 'Screening Division, Public Health Wales, Cardiff, UK.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Heard', 'Affiliation': 'Bowel Screening Wales, Public Health Wales, Llantrisant, UK.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Dolwani', 'Affiliation': 'Division of Population Medicine, Cardiff University School of Medicine, Cardiff, UK. Electronic address: dolwanis@cardiff.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30035-4']
1197,32407242,Exogenous ketosis impacts neither performance nor muscle glycogen breakdown in prolonged endurance exercise.,"Available evidence indicates that ketone bodies inhibit glycolysis in contracting muscles. Therefore, we investigated whether acute exogenous ketosis by oral ketone ester (KE) intake early in a simulated cycling race, can induce transient glycogen sparing by glycolytic inhibition thereby increasing glycogen availability in the final phase of the event. In a randomized cross-over design, 12 highly-trained male cyclists completed a simulated cycling race (RACE), which consisted of 3h intermittent cycling (IMT 180' ), a 15-min time-trial (TT 15' ) and a maximal sprint (SPRINT). During RACE subjects received 60g carbohydrates per h combined with three boluses (25-20-20g) (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (KE) or a control drink (CON) at 60 and 20 min before, and at 30 min during RACE.KE intake transiently increased blood D-ß-hydroxybutyrate to ~3 mM (range: 2.6-5.2 mM) during the first half of RACE (p<0.001 vs. CON). Blood pH concomitantly decreased from ~7.42 to 7.36 (range: 7.29-7.40), whilst bicarbonate dropped from 26.0 to 21.6 mM (range: 20.1-23.7) (both p<0.001 vs. CON) .  Net muscle glycogen breakdown during IMT 180'  (KE: -78±30 (SD); CON: -60±22 mmol/kg ww, p=0.08) and TT 15'  (KE: -9±18; CON: -18±18 mmol/kg ww, p=0.35) was similar between KE and CON. Accordingly, mean power output during TT 15'  (KE: 273±38; CON: 272±37 W, p=0.83) and time-to-exhaustion in the SPRINT (KE: 59±16; CON: 58±17 s, p=0.66) were similar between conditions. In conclusion, KE intake during a simulated cycling race does not cause glycogen sparing, neither does it affect all-out performance in the final stage of a simulated race.",2020,"CON: -60±22 mmol/kg ww, p=0.08) and TT 15'  (KE: -9±18; CON: -18±18 mmol/kg ww, p=0.35) was similar between KE and CON.",['12 highly-trained male cyclists completed a simulated cycling race (RACE'],"[""IMT 180'  (KE: -78±30 (SD"", 'R)-3-hydroxybutyl (R)-3-hydroxybutyrate (KE) or a control drink (CON', 'oral ketone ester (KE', 'maximal sprint (SPRINT']","['time-to-exhaustion', 'Blood pH', 'Net muscle glycogen breakdown']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}]","[{'cui': 'C0334121', 'cui_str': 'Inflammatory myofibroblastic tumor'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0014898', 'cui_str': 'Ester'}, {'cui': 'C3529323', 'cui_str': '(R)-3-hydroxybutyl (R)-3-hydroxybutyrate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0853363', 'cui_str': 'Blood pH'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0596624', 'cui_str': 'Glycogenolysis'}]",,0.132524,"CON: -60±22 mmol/kg ww, p=0.08) and TT 15'  (KE: -9±18; CON: -18±18 mmol/kg ww, p=0.35) was similar between KE and CON.","[{'ForeName': 'Chiel', 'Initials': 'C', 'LastName': 'Poffé', 'Affiliation': 'Department of Movement Sciences, KU Leuven, Belgium.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Ramaekers', 'Affiliation': 'Department of Movemnet, KU Leuven, Belgium.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Bogaerts', 'Affiliation': 'Department of Development and Regeneration, KU Leuven, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hespel', 'Affiliation': 'Department of Movement Sciences, KU Leuven, Belgium.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00092.2020']
1198,30304644,The effects and costs of home-based rehabilitation for heart failure with reduced ejection fraction: The REACH-HF multicentre randomized controlled trial.,"BACKGROUND


Cardiac rehabilitation improves health-related quality of life (HRQoL) and reduces hospitalizations in patients with heart failure, but international uptake of cardiac rehabilitation for heart failure remains low.
DESIGN AND METHODS


The aim of this multicentre randomized trial was to compare the REACH-HF (Rehabilitation EnAblement in CHronicHeart Failure) intervention, a facilitated self-care and home-based cardiac rehabilitation programme to usual care for adults with heart failure with reduced ejection fraction (HFrEF). The study primary hypothesis was that the addition of the REACH-HF intervention to usual care would improve disease-specific HRQoL (Minnesota Living with Heart Failure questionnaire (MLHFQ)) at 12 months compared with usual care alone.
RESULTS


The study recruited 216 participants, predominantly men (78%), with an average age of 70 years and mean left ventricular ejection fraction of 34%. Overall, 185 (86%) participants provided data for the primary outcome. At 12 months, there was a significant and clinically meaningful between-group difference in the MLHFQ score of -5.7 points (95% confidence interval -10.6 to -0.7) in favour of the REACH-HF intervention group ( p = 0.025). With the exception of patient self-care ( p < 0.001) there was no significant difference in other secondary outcomes, including clinical events ( p > 0.05) at follow-up compared with usual care. The mean cost of the REACH-HF intervention was £418 per participant.
CONCLUSIONS


The novel REACH-HF home-based facilitated intervention for HFrEF was clinically superior in disease-specific HRQoL at 12 months and offers an affordable alternative to traditional centre-based programmes to address current low cardiac rehabilitation uptake rates for heart failure.",2019,"With the exception of patient self-care ( p < 0.001) there was no significant difference in other secondary outcomes, including clinical events ( p > 0.05) at follow-up compared with usual care.","['216 participants, predominantly men (78%), with an average age of 70 years and mean left ventricular ejection fraction of 34', 'adults with heart failure with reduced ejection fraction (HFrEF', 'patients with heart failure', 'heart failure with reduced ejection fraction']","['usual care alone', 'home-based rehabilitation', 'REACH-HF (Rehabilitation EnAblement in CHronicHeart Failure) intervention, a facilitated self-care and home-based cardiac rehabilitation programme']","['MLHFQ score', 'health-related quality of life (HRQoL', 'clinical events', 'mean cost of the REACH-HF intervention', 'disease-specific HRQoL (Minnesota Living with Heart Failure questionnaire (MLHFQ']","[{'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",216.0,0.130828,"With the exception of patient self-care ( p < 0.001) there was no significant difference in other secondary outcomes, including clinical events ( p > 0.05) at follow-up compared with usual care.","[{'ForeName': 'Hasnain M', 'Initials': 'HM', 'LastName': 'Dalal', 'Affiliation': '1 Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Rod S', 'Initials': 'RS', 'LastName': 'Taylor', 'Affiliation': '1 Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jolly', 'Affiliation': '3 Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Russell C', 'Initials': 'RC', 'LastName': 'Davis', 'Affiliation': '4 Cardiology Department, Sandwell & West Birmingham Hospitals NHS Trust, Birmingham, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Doherty', 'Affiliation': '5 Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Miles', 'Affiliation': '6 Research and Development, Aneurin Bevan University Health Board, St Woolos Hospital, Newport, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'van Lingen', 'Affiliation': '7 Duchy Hospital, Truro, UK.'}, {'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Warren', 'Affiliation': '1 Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': '1 Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wingham', 'Affiliation': '1 Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Greaves', 'Affiliation': '8 Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Sadler', 'Affiliation': '1 Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Melvyn', 'Initials': 'M', 'LastName': 'Hillsdon', 'Affiliation': '9 Sport and Health Sciences, University of Exeter, Exeter, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Abraham', 'Affiliation': '10 Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Britten', 'Affiliation': '1 Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Frost', 'Affiliation': '1 Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': '11 Centre for Exercise and Rehabilitation Science, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hayward', 'Affiliation': '12 Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Eyre', 'Affiliation': '13 Re:Cognition Health, London, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Paul', 'Affiliation': '14 REACH-HF Patient and Public Involvement Group, c/o Research, Development & Innovation, Royal Cornwall Hospitals NHS Trust, Truro, UK.'}, {'ForeName': 'Chim C', 'Initials': 'CC', 'LastName': 'Lang', 'Affiliation': '15 School of Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': '16 School of Nursing and Health Sciences, University of Dundee, Dundee, UK.'}]",European journal of preventive cardiology,['10.1177/2047487318806358']
1199,17679735,Management of patients with fibromyalgia using biofeedback: a randomized control trial.,"OBJECTIVE


Fibromyalgia syndrome (FMS) is a chronic rheumatological condition which could be characterized by generalized pain and fatigue. Cognitive and behavioral therapy has been found to be a suitable technique in the management of FMS. This study intends to evaluate the efficacy of electromyography (EMG) biofeedback to reduce pain in patients with FMS.
MATERIALS AND METHODS


A randomized controlled trial involving two groups of FMS patients, one receiving EMG biofeedback and the other a sham biofeedback, was carried out. The assessment tools included in the study were fibromyalgia impact questionnaire (FIQ), visual analogue scale (VAS), six-minute walk test (SMWT) and number of tender points; and tenderness of each tender point was done for both the groups.
STATISTICS


A Student's 't' test was used to study the test for significance.
RESULTS


After using biofeedback, the mean VAS scores and the mean number of tender points were found to be 3 out of 10 and 6 out of 18 respectively. Subjective analysis from both groups showed improvement in physical and psychological realms. Statistical significance.
CONCLUSION


Biofeedback as a treatment modality reduces pain in patients with FMS, along with improvements in FIQ, SMWT and the number of tender points.",2007,"CONCLUSION


Biofeedback as a treatment modality reduces pain in patients with FMS, along with improvements in FIQ, SMWT and the number of tender points.","['patients with FMS', 'patients with fibromyalgia using biofeedback', 'Fibromyalgia syndrome (FMS', 'two groups of FMS patients, one receiving']","['electromyography (EMG) biofeedback', 'EMG biofeedback and the other a sham biofeedback', 'Cognitive and behavioral therapy']","['pain', 'physical and psychological realms', 'fibromyalgia impact questionnaire (FIQ), visual analogue scale (VAS), six-minute walk test (SMWT) and number of tender points; and tenderness of each tender point', 'mean VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1562820', 'cui_str': 'Tender point'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0782063,"CONCLUSION


Biofeedback as a treatment modality reduces pain in patients with FMS, along with improvements in FIQ, SMWT and the number of tender points.","[{'ForeName': 'Abraham S', 'Initials': 'AS', 'LastName': 'Babu', 'Affiliation': 'Department of Physiotherapy, Christian Medical College, Vellore, India. abrahambabu@gmail.com'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Mathew', 'Affiliation': ''}, {'ForeName': 'Debashish', 'Initials': 'D', 'LastName': 'Danda', 'Affiliation': ''}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Prakash', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1200,17558098,Immunomodulatory role of Tinospora cordifolia as an adjuvant in surgical treatment of diabetic foot ulcers: a prospective randomized controlled study.,"BACKGROUND


Chronic diabetic patients with wounds have deficient growth factors and impaired local and systemic cellular immunity. Treatment with growth factors is expensive with risk of infection transmission and these factors may not achieve optimum wound concentration. We evaluated the role of generalized immunomodulation in diabetic ulcers by using Tinospora cordifolia as an adjuvant therapy and studied its influence on parameters/determinants of healing, on bacterial eradication and on polymorphonuclear phagocytosis.
MATERIALS AND METHODS


A prospective double-blind randomized controlled study lasting for over 18 months in 50 patients. The ulcer was classified by wound morphology and severity with Wound Severity Score (Pecoraro-Reiber system). Mean ulcer area, depth and perimeter were measured and swabs taken for culture. Blood was collected to assess polymorphonuclear % phagocytosis (PMN function by Lehrer-Cline C. albicans method). Medical therapy, glycemic control, debridement, wound care were optimized. At 4 weeks, parameters were reassessed. PMN function was reviewed at 3 months.
RESULTS AND ANALYSIS


Forty-five patients completed the trial: study group - 23 (M:F = 17:1; mean age = 56.3 years; mean ulcer duration = 21.1 days); control group 22 (M:F = 19:3; mean age = 56.3 years; mean ulcer duration = 30.4 days). Net improvement was seen in 17 patients (73.9%) in the study group; while in the control group, in 13 patients (59.1%); P = 0.292. Specific parameters included rate of change of ulcer area - cm(2) /day (study - 0.15; control - 0.07; P = 0.145); rate of change of ulcer perimeter - mm/day (study - 0.09; control = - 0.07; P = 0.089); change of depth - mm (study - 2.2; control - 1.4; P = 0.096); change of wound score (study - 14.4; control - 10.6; P = 0.149); total number of debridements (study - 1.9; control - 2.5; P = 0.03) and change in % phagocytosis (study - 3.9; control - 2.3; P = 0.048).
CONCLUSION


Diabetic patients with foot ulcers on T. cordifolia as an adjuvant therapy showed significantly better final outcome with improvement in wound healing. Reduced debridements and improved phagocytosis were statistically significant, indicating beneficial effects of immunomodulation for ulcer healing.",2007,"Net improvement was seen in 17 patients (73.9%) in the study group; while in the control group, in 13 patients (59.1%); P = 0.292.","['50 patients', 'Forty-five patients completed the trial: study group - 23 (M:F = 17:1; mean age = 56.3 years; mean ulcer duration = 21.1 days); control group 22 (M:F = 19:3; mean age = 56.3 years; mean ulcer duration = 30.4 days', 'diabetic foot ulcers', 'Chronic diabetic patients with wounds']",['Tinospora cordifolia'],"['wound healing', 'Net improvement', 'Mean ulcer area, depth and perimeter', 'change of wound score', 'rate of change of ulcer area - cm(2) /day', 'Reduced debridements and improved phagocytosis', 'PMN function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0021501', 'cui_str': 'wounds'}]","[{'cui': 'C1009737', 'cui_str': 'Tinospora'}]","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0182215', 'cui_str': 'Perimeter'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0031308', 'cui_str': 'Phagocytosis'}, {'cui': 'C0031843', 'cui_str': 'function'}]",50.0,0.025259,"Net improvement was seen in 17 patients (73.9%) in the study group; while in the control group, in 13 patients (59.1%); P = 0.292.","[{'ForeName': 'Harshad', 'Initials': 'H', 'LastName': 'Purandare', 'Affiliation': 'Department of Surgery, Seth G. S. Medical College and K. E. M. Hospital, Mumbai, India.'}, {'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Supe', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1201,30895611,"Combined vaginal administration of nystatin, diiodohydroxyquin, and benzalkonium chloride versus oral metronidazole for the treatment of bacterial vaginosis.","OBJECTIVE


To compare combined vaginal administration of nystatin, diiodohydroxyquin, and benzalkonium chloride versus oral metronidazole for the treatment of bacterial vaginosis (BV).
METHODS


A randomized controlled trial was conducted among women diagnosed with BV using the Amsel criteria (n=90) at a university hospital in Khon Kaen, Thailand, between June 27, 2017, and April 30, 2018. The oral metronidazole group (n=44) received 400 mg of metronidazole, administered three times per day. The combined vaginal tablet group (n=46) received a vaginal suppository once daily, which comprised nystatin (100 000 U), diiodohydroxyquin (100 mg), and benzalkonium chloride (7 mg). Treatment was administered for 7 days in both groups. Follow-up visits at 14 and 42 days assessed treatment outcomes and adverse effects.
RESULTS


Remission of BV occurred among 41 (93%) women in the oral metronidazole group and 39 (85%) women in the combined vaginal tablet group. The adjusted relative risk was 0.92 (95% confidence interval 0.80-1.06). The rate of nausea and/or vomiting was significantly higher in the oral metronidazole group than that in the combined vaginal tablet group.
CONCLUSION


Treatment efficacy of the combined vaginal tablet versus oral metronidazole was equivalent.
CLINICAL TRIAL REGISTRATION


TCTR20170627001 (www.clinicaltrials.in.th).",2019,"The rate of nausea and/or vomiting was significantly higher in the oral metronidazole group than that in the combined vaginal tablet group.
","['bacterial vaginosis', 'bacterial vaginosis (BV', 'women diagnosed with BV using the Amsel criteria (n=90) at a university hospital in Khon Kaen, Thailand, between June 27, 2017, and April 30, 2018']","['diiodohydroxyquin', 'vaginal suppository once daily, which comprised nystatin', 'metronidazole', 'nystatin, diiodohydroxyquin, and benzalkonium chloride versus oral metronidazole', 'benzalkonium chloride', '400\xa0mg of metronidazole']","['Remission of BV', 'adverse effects', 'rate of nausea and/or vomiting']","[{'cui': 'C0085166', 'cui_str': 'Vaginitis, Nonspecific'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}]","[{'cui': 'C0012341', 'cui_str': 'diiodohydroxyquinoline'}, {'cui': 'C1136199', 'cui_str': 'Vaginal Suppository'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0028741', 'cui_str': 'Nystatin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0005026', 'cui_str': 'Benzalkonium Chloride'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}]",,0.189946,"The rate of nausea and/or vomiting was significantly higher in the oral metronidazole group than that in the combined vaginal tablet group.
","[{'ForeName': 'Wichinee', 'Initials': 'W', 'LastName': 'Chooprasertsuk', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Woraluk', 'Initials': 'W', 'LastName': 'Somboonporn', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Sukree', 'Initials': 'S', 'LastName': 'Soontrapa', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'LingLing', 'Initials': 'L', 'LastName': 'Salang', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Siriruthai', 'Initials': 'S', 'LastName': 'Amnatbuddee', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.12805']
1202,31709969,Vitamin A intakes remain higher among intervention participants 3 years after a biofortification intervention in Mozambique.,"The Reaching End Users (REU) project introduced orange sweet potatoes (OSP) to farmers in northern Mozambique between 2006 and 2009, and the associated cluster randomised control trial found increased vitamin A intake among targeted children and women of child-bearing age and reduced prevalence of inadequate vitamin A intake. Yet little is known about whether successful agricultural-nutrition interventions have lasting effects. This study measures the lasting effects of the REU project, 3 years after the project ended, on vitamin A intake. To do so, dietary intake data were collected in the same thirty-six villages as the original study, focusing on both women of child-bearing age and children under 6 years old, the latter including both children who had been measured before and younger children (under 3 years old) in the same farmer groups. The dietary intake is then converted to micronutrient intake to compare treated households with control households. Vitamin A intake remains higher in treated villages than in control villages among both children under 3 years old, who had not been born when the original intervention ended, and mothers of child-bearing age. Differences in vitamin A intake can wholly be attributed to differences in OSP intake. Therefore, the REU project appears to have had lasting impacts on vitamin A intake beyond the intervention period. Had the vine retention component been enhanced, lasting impacts could have been even larger.",2019,"Vitamin A intake remains higher in treated villages than in control villages among both children under 3 years old, who had not been born when the original intervention ended, and mothers of child-bearing age.","['children under 3 years old, who had not been born when the original intervention ended, and mothers of child-bearing age', 'treated households with control households', 'same thirty-six villages as the original study, focusing on both women of child-bearing age and children under 6 years old, the latter including both children who had been measured before and younger children (under 3 years old) in the same farmer groups']",[],['vitamin A intake'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0221460', 'cui_str': 'Agricultural Workers'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0564436', 'cui_str': 'Vitamin A intake (observable entity)'}]",,0.0309355,"Vitamin A intake remains higher in treated villages than in control villages among both children under 3 years old, who had not been born when the original intervention ended, and mothers of child-bearing age.","[{'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'de Brauw', 'Affiliation': 'Markets, Trade, and Institutions Division, International Food Policy Research Institute, Washington, DC 20005, USA.'}, {'ForeName': 'Mourad', 'Initials': 'M', 'LastName': 'Moursi', 'Affiliation': 'FHI 360, Washington, DC 20009; Formerly HarvestPlus/International Food Policy Research Institute, Washington, DC 20005, USA.'}, {'ForeName': 'A Bernardinho', 'Initials': 'AB', 'LastName': 'Munhaua', 'Affiliation': 'MUVA, Monitoring, Evaluation, and Learning Department, Francisco Orlando Magumbwé Avenue, Maputo, Mozambique.'}]",The British journal of nutrition,['10.1017/S0007114519002162']
1203,30895706,Long-term impact of diabetes in patients with ST-segment elevation myocardial infarction: Insights from the EXAMINATION randomized trial.,"BACKGROUND


Long-term outcomes of diabetic patients suffering from ST-segment elevation myocardial infarction (STEMI) and treated with second-generation drug-eluting stent have been scarcely evaluated. The aim of this posthoc subanalysis of the EXAMINATION trial was to compare 5-year outcomes according to the presence of diabetes mellitus.
METHODS


From a total of 1,497 patients included in the trial, 258 were diabetics (n = 137, received everolimus-eluting stent (EES) and n = 121 bare-metal stent (BMS); whereas 1,239 were nondiabetics (n = 613 treated with EES and n = 626 with BMS). Patient-oriented combined endpoint (POCE) defined as all-cause death, any MI or any revascularization, and other clinical parameters were collected up to 5-years. All results were adjusted for various potential confounders.
RESULTS


At 5-years, patients with diabetes showed similar rates of POCE between diabetics treated with EES and those treated with BMS (32.8% vs. 32.2%; p = 0.88). However, rates of TLR were significantly lower in the EES group (4.4% vs. 9.9%; HR 0.52 (0.29-0.94); P = 0.03). In non-diabetics, the use of EES was associated with a significant improvement in all-clinical parameters except for MI rate: POCE: [10.0% vs. 12.6%; HR 0.78(0.62-0.98); P = 0.038], all cause death: [7.0% vs. 12.1%; HR 0.62(0.42-0.90); P = 0.014], and [TLR: 4.2 vs. 6.7; HR 0.60 (0.37-0.98); P = 0.04]. Overall, diabetics showed higher rate of POCE at 5-years (32.6% vs. 21.5% in nondiabetics HR1.45[1.03-2.04];p = 0.03) driven by increased rates of MI and the need for revascularization that occurred in coronary segments remote from target lesions [2.7% vs. 1.1%; HR: 2.27 (1.12-5.23); P = 0.02 and 14% vs. 6.2%; HR: 2.11 (1.38-3.22); P = 0.001, respectively].
CONCLUSIONS


Diabetics had worse clinical outcomes than nondiabetics after STEMI mainly due to atherosclerosis progression. At 5-years, the treatment with EES did not reduce the rate of POCE in diabetics but reduced the need for revascularization compared with BMS.",2019,"In non-diabetics, the use of EES was associated with a significant improvement in all-clinical parameters except for MI rate: POCE: [10.0% vs. 12.6%; HR 0.78(0.62-0.98); P = 0.038], all cause death: [7.0% vs. 12.1%; HR 0.62(0.42-0.90); P = 0.014], and [TLR: 4.2 vs. 6.7; HR 0.60 (0.37-0.98); P = 0.04].","['1,497 patients included in the trial, 258 were diabetics (n =\u2009137, received everolimus-eluting stent (EES) and n =\u2009121 bare-metal stent (BMS); whereas 1,239 were nondiabetics (n =\u2009613 treated with EES and n =\u2009626 with BMS', 'patients with ST-segment elevation myocardial infarction', 'diabetic patients suffering from ST-segment elevation myocardial infarction (STEMI']","['BMS', 'EES']","['rates of MI and the need for revascularization', 'rates of POCE', 'cause death', 'rate of POCE', 'rates of TLR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent (physical object)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}]",[],"[{'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1497.0,0.0986733,"In non-diabetics, the use of EES was associated with a significant improvement in all-clinical parameters except for MI rate: POCE: [10.0% vs. 12.6%; HR 0.78(0.62-0.98); P = 0.038], all cause death: [7.0% vs. 12.1%; HR 0.62(0.42-0.90); P = 0.014], and [TLR: 4.2 vs. 6.7; HR 0.60 (0.37-0.98); P = 0.04].","[{'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Jimenez-Quevedo', 'Affiliation': 'Interventional Cardiology Department, Clinico San Carlos University Hospital, IdISSC, Madrid, Spain.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Brugaletta', 'Affiliation': ""Interventional Cardiology Department, University Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Cequier', 'Affiliation': 'Interventional Cardiology Department, University Hospital of Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Iñiguez', 'Affiliation': 'Interventional Cardiology Department, Hospital do Meixoeiro, Vigo, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Serra', 'Affiliation': 'Interventional Cardiology Department, University Hospital of Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Mainar', 'Affiliation': 'Interventional Cardiology Department, Hospital General of Alicante, Alicante, Spain.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Campo', 'Affiliation': 'Interventional Cardiology Department, University Hospital Ferrara, Ferrara, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Tespili', 'Affiliation': 'Interventional Cardiology Department, University Hospital Bolognini Seriate, Bergamo, Italy.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Nombela-Franco', 'Affiliation': 'Interventional Cardiology Department, Clinico San Carlos University Hospital, IdISSC, Madrid, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Del Trigo', 'Affiliation': 'Interventional Cardiology Department, Clinico San Carlos University Hospital, IdISSC, Madrid, Spain.'}, {'ForeName': 'Nieves', 'Initials': 'N', 'LastName': 'Gonzalo', 'Affiliation': 'Interventional Cardiology Department, Clinico San Carlos University Hospital, IdISSC, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Interventional Cardiology Department, Clinico San Carlos University Hospital, IdISSC, Madrid, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Salinas', 'Affiliation': 'Interventional Cardiology Department, Clinico San Carlos University Hospital, IdISSC, Madrid, Spain.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Nuñez-Gil', 'Affiliation': 'Interventional Cardiology Department, Clinico San Carlos University Hospital, IdISSC, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fernandez-Perez', 'Affiliation': 'Interventional Cardiology Department, Clinico San Carlos University Hospital, IdISSC, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Fernández-Ortiz', 'Affiliation': 'Interventional Cardiology Department, Clinico San Carlos University Hospital, IdISSC, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Macaya', 'Affiliation': 'Interventional Cardiology Department, Clinico San Carlos University Hospital, IdISSC, Madrid, Spain.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Interventional Cardiology Department, International Centre of Circulatory Health, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabate Tenas', 'Affiliation': ""Interventional Cardiology Department, University Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28194']
1204,31710269,A mobile app to promote alcohol and drug SBIRT skill translation among multi-disciplinary health care trainees: Results of a randomized controlled trial.,"Background : Adherence to clinical practice guidelines for alcohol and drug screening, brief intervention, and referral to treatment (SBIRT) is often inadequate. Mobile apps developed as clinical translation tools could improve the delivery of high fidelity SBIRT.  Methods : This study tested the effectiveness of an SBIRT mobile app conceptually aligned with the Theory of Planned Behavior (TPB) to support SBIRT delivery by health care trainees (nursing, social work, internal medicine, psychiatry, and psychology) working in clinical settings ( N  = 101). Bivariate analyses examined the rate of SBIRT delivery between trainees assigned to the experimental (app) and control (no app) study conditions; as well as the relationship between TPB-based constructs, intention to deliver SBIRT, and screening rates.  Results : No significant differences were identified between the study conditions in SBIRT delivery. Significant correlations were found between intent to screen and TPB variables including attitudes/behavioral beliefs concerning substance use treatment ( r  = .49,  p  = .01); confidence in clinical skills ( r  = .36,  p  = .01); subjective norms ( r  = .54,  p  = .01) and perceived behavioral control over appointment time constraints ( r  = .42,  p  = .01). Also significant were correlations between percent of patients screened and confidence ( r  = .24,  p  = .05); subjective norms ( r  = .22,  p  = .05) and perceived behavioral control ( r  = .28,  p  = .01).  Conclusions : The negative results of the study condition comparisons indicate the need for further investigation of strategies to optimize mobile app utilization, engagement, and effectiveness as a clinical translation tool. Findings of significant correlations between substance use screening rates and both norms and confidence support the potential value of the TPB model in explaining behavior of health care learners in SBIRT delivery.",2019,"Bivariate analyses examined the rate of SBIRT delivery between trainees assigned to the experimental (app) and control (no app) study conditions; as well as the relationship between TPB-based constructs, intention to deliver SBIRT, and screening rates.  ",['multi-disciplinary health care trainees'],"[' ', 'SBIRT mobile app conceptually aligned with the Theory of Planned Behavior (TPB']","['rate of SBIRT delivery', 'screen and TPB variables including attitudes/behavioral beliefs concerning substance use treatment', 'behavioral control']","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C2369992', 'cui_str': 'Align'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0150359', 'cui_str': 'Substance use treatments and procedures'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.0380138,"Bivariate analyses examined the rate of SBIRT delivery between trainees assigned to the experimental (app) and control (no app) study conditions; as well as the relationship between TPB-based constructs, intention to deliver SBIRT, and screening rates.  ","[{'ForeName': 'Alexa C', 'Initials': 'AC', 'LastName': 'Curtis', 'Affiliation': 'School of Nursing and Health Professions, University of San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Satre', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, San Francisco, California, USA.'}, {'ForeName': 'Varada', 'Initials': 'V', 'LastName': 'Sarovar', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Wamsley', 'Affiliation': 'Division of General Internal Medicine, University of California, San Francisco, California, USA.'}, {'ForeName': 'Khanh', 'Initials': 'K', 'LastName': 'Ly', 'Affiliation': 'Division of General Internal Medicine, University of California, San Francisco, California, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Satterfield', 'Affiliation': 'Division of General Internal Medicine, University of California, San Francisco, California, USA.'}]",Substance abuse,['10.1080/08897077.2019.1686723']
1205,31708152,"Effect of co-trimoxazole prophylaxis on morbidity and mortality of HIV-exposed, HIV-uninfected infants in South Africa: a randomised controlled, non-inferiority trial.","BACKGROUND


WHO guidelines recommend co-trimoxazole prophylaxis for HIV-exposed, HIV-uninfected infants. These guidelines date back to an era in which HIV testing of infants was impossible and mothers had poor access to antiretroviral treatment. To determine whether this guideline requires revision in the current era of effective prevention of mother-to-child transmission and early infant diagnosis programmes, we aimed to investigate whether receiving no co-trimoxazole prophylaxis is inferior to receiving co-trimoxazole prophylaxis in the resulting incidence of grade 3 or 4 common childhood illnesses or mortality in breastfed HIV-exposed, HIV-uninfected infants.
METHODS


We investigated our aim in a randomised controlled, non-inferiority trial. We enrolled the HIV-negative infants of mothers living with HIV who were actively involved in transmission prevention programmes in two clinics in Durban, South Africa. Infants were included in the study if they were breastfeeding at the screening and enrolment visits, and their mother was planning to breastfeed for at least 6 months; were a singleton birth and had a birthweight of 2 kg or more; had no clinically observed genetic disorders; and had no serious illnesses and had not received antibiotics or traditional medications (such as herbal remedies). Infants were randomly assigned (1:1) to receive co-trimoxazole or no co-trimoxazole. In the co-trimoxazole group, infants received the drug until all exposure to HIV had ceased (ie, 6 weeks after last exposure to breastmilk) and the infant was confirmed to be uninfected with HIV. The drug was administered by mothers in once-daily regimens of 20 mg trimethoprim and 100 mg sulfamethoxazole orally (age <6 months or bodyweight <5 kg), or 40 mg trimethoprim and 200 mg sulfamethoxazole orally (age >6 months or bodyweight >5 kg). Clinical and laboratory staff always remained masked to group assignment, but mothers and study counsellors were not. Infants and their mothers attended study visits at ages 6 weeks (for enrolment and randomisation), 10 weeks, 14 weeks, and then monthly from 4 to 12 months. Our primary outcome was the incidence of grade 3 or 4 common childhood illnesses (pneumonia or diarrhoea) or mortality in breastfed HIV-exposed, HIV-uninfected infants by age 12 months. A non-inferiority bound of 5% was used. The study is registered with the Pan African Clinical Trials Registry, number PACTR201311000621110, and the South African National Clinical Trials Registry, number DOH-27-0614-4728.
FINDINGS


We screened 1570 mother-child pairs for study enrolment, from whom (78%) eligible infants were enrolled into the study between Oct 16, 2013, and May 23, 2018. Of the infants enrolled, 611 (50%) were randomly assigned to the co-trimoxazole group and 609 (50%) were randomly assigned to the no co-trimoxazole group. One (<1%) infant in the no co-trimoxazole group was excluded from the analysis of the final outcomes for having received traditional medicine (which only became apparent after randomisation); therefore, 611 (50%) infants in the co-trimoxazole group and 608 (50%) infants in the no co-trimoxazole group were included in the final intention-to-treat analysis. 136 (22%) infants in the co-trimoxazole group and 139 (23%) infants in the no co-trimoxazole group did not complete the 12-month study visit, predominantly because of loss to follow-up (93 [15%] infants in the co-trimoxazole group; 90 [15%] infants in the no co-trimoxazole group). The cumulative probability of the composite primary outcome was 0·114 (95% CI 0·076 to 0·147; 49 events) in the co-trimoxazole group versus 0·0795 (0·044 to 0·115; 39 events) in the no co-trimoxazole group. The risk difference (no co-trimoxazole group minus co-trimoxazole group) was -0·0319 (-0·075 to 0·011), meaning that the risk was around 3 percentage points lower in the no co-trimoxazole group on the additive scale.
INTERPRETATION


We can conclude that no co-trimoxazole is not inferior to daily co-trimoxazole among breastfed HIV-exposed, HIV-uninfected infants whose mothers are accessing a prevention of mother-to-child transmission programme in an area unaffected by malaria. We therefore believe that WHO should revise the co-trimoxazole guidelines for HIV-exposed, HIV-uninfected infants in areas unaffected by malaria.
FUNDING


HIV Prevention Research Unit of the South African Medical Research Council and the Family Larsson-Rosenquist Foundation.",2019,The risk difference (no co-trimoxazole group minus co-trimoxazole group) was -0·0319,"['Infants were included in the study if they were breastfeeding at the screening and enrolment visits, and their mother was planning to breastfeed for at least 6 months; were a singleton birth and had a birthweight of 2 kg or more; had no clinically observed genetic disorders; and had no serious illnesses and had not received antibiotics or traditional medications (such as herbal remedies', 'HIV-negative infants of mothers living with HIV who were actively involved in transmission prevention programmes in two clinics in Durban, South Africa', '1570 mother-child pairs for study enrolment, from whom (78%) eligible infants were enrolled into the study between Oct 16, 2013, and May 23, 2018', 'for HIV-exposed, HIV-uninfected infants', 'HIV-exposed, HIV-uninfected infants in South Africa', 'group and 609 (50', 'infants enrolled, 611 (50']","['trimoxazole', 'trimethoprim', 'co-trimoxazole prophylaxis', 'sulfamethoxazole', 'co-trimoxazole or no co-trimoxazole', 'trimoxazole prophylaxis', 'no co-trimoxazole']","['incidence of grade 3 or 4 common childhood illnesses (pneumonia or diarrhoea) or mortality', 'cumulative probability of the composite primary outcome', 'morbidity and mortality']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0205172', 'cui_str': 'More (qualifier value)'}, {'cui': 'C0019247', 'cui_str': 'Hereditary Diseases'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0041041', 'cui_str': 'Trimethoprim'}, {'cui': 'C0041044', 'cui_str': 'Sulfamethoxazole / Trimethoprim'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0038689', 'cui_str': 'Sulfamethoxazole'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",1570.0,0.0844087,The risk difference (no co-trimoxazole group minus co-trimoxazole group) was -0·0319,"[{'ForeName': 'Brodie', 'Initials': 'B', 'LastName': 'Daniels', 'Affiliation': 'Department of Paediatrics and Child Health, School of Clinical Medicine, University of KwaZulu-Natal, Durban, South Africa; HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Coutsoudis', 'Affiliation': 'Department of Paediatrics and Child Health, School of Clinical Medicine, University of KwaZulu-Natal, Durban, South Africa. Electronic address: coutsoud@ukzn.ac.za.'}, {'ForeName': 'Eshia', 'Initials': 'E', 'LastName': 'Moodley-Govender', 'Affiliation': 'Department of Obstetrics and Gynaecology, School of Clinical Medicine, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Mulol', 'Affiliation': 'Department of Paediatrics and Child Health, School of Clinical Medicine, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Spooner', 'Affiliation': 'Department of Paediatrics and Child Health, School of Clinical Medicine, University of KwaZulu-Natal, Durban, South Africa; HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'Photini', 'Initials': 'P', 'LastName': 'Kiepiela', 'Affiliation': 'Medical Research Council of South Africa/Wits Health Consortium, Durban, South Africa.'}, {'ForeName': 'Shabashini', 'Initials': 'S', 'LastName': 'Reddy', 'Affiliation': 'Medical Research Council of South Africa/Wits Health Consortium, Durban, South Africa.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Zako', 'Affiliation': 'eThekwini Municipality Health Unit, Durban, South Africa.'}, {'ForeName': 'Nhan T', 'Initials': 'NT', 'LastName': 'Ho', 'Affiliation': 'Department of Epidemiology, Mailman School of Public Health, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Kuhn', 'Affiliation': 'Department of Epidemiology, Mailman School of Public Health, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Ramjee', 'Affiliation': 'HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa; Aurum Institute, Johannesburg, South Africa.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30422-X']
1206,28231626,Default mode network deactivation to smoking cue relative to food cue predicts treatment outcome in nicotine use disorder.,"Identifying predictors of treatment outcome for nicotine use disorders (NUDs) may help improve efficacy of established treatments, like varenicline. Brain reactivity to drug stimuli predicts relapse risk in nicotine and other substance use disorders in some studies. Activity in the default mode network (DMN) is affected by drug cues and other palatable cues, but its clinical significance is unclear. In this study, 143 individuals with NUD (male n = 91, ages 18-55 years) received a functional magnetic resonance imaging scan during a visual cue task during which they were presented with a series of smoking-related or food-related video clips prior to randomization to treatment with varenicline (n = 80) or placebo. Group independent components analysis was utilized to isolate the DMN, and temporal sorting was used to calculate the difference between the DMN blood-oxygen-level dependent signal during smoke cues and that during food cues for each individual. Food cues were associated with greater deactivation compared with smoke cues in the DMN. In correcting for baseline smoking and other clinical variables, which have been shown to be related to treatment outcome in previous work, a less positive Smoke - Food difference score predicted greater smoking at 6 and 12 weeks when both treatment groups were combined (P = 0.005, β = -0.766). An exploratory analysis of executive control and salience networks demonstrated that a more positive Smoke - Food difference score for executive control network predicted a more robust response to varenicline relative to placebo. These findings provide further support to theories that brain reactivity to palatable cues, and in particular in DMN, may have a direct clinical relevance in NUD.",2018,"Food difference score predicted greater smoking at 6 and 12 weeks when both treatment groups were combined (P = 0.005, β = -0.766).","['143 individuals with NUD (male n\xa0=\xa091, ages 18-55\xa0years']","['varenicline', 'functional magnetic resonance imaging scan during a visual cue task during which they were presented with a series of smoking-related or food-related video clips prior to randomization to treatment with varenicline', 'placebo']",['DMN blood-oxygen-level dependent signal during smoke cues'],"[{'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0441633'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]",143.0,0.086673,"Food difference score predicted greater smoking at 6 and 12 weeks when both treatment groups were combined (P = 0.005, β = -0.766).","[{'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Wilcox', 'Affiliation': 'Department of Psychiatry, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Claus', 'Affiliation': 'Mind Research Network and Lovelace Biomedical and Environmental Research Institute, Albuquerque, NM, USA.'}, {'ForeName': 'Vince D', 'Initials': 'VD', 'LastName': 'Calhoun', 'Affiliation': 'Mind Research Network and Lovelace Biomedical and Environmental Research Institute, Albuquerque, NM, USA.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Rachakonda', 'Affiliation': 'Mind Research Network and Lovelace Biomedical and Environmental Research Institute, Albuquerque, NM, USA.'}, {'ForeName': 'Rae A', 'Initials': 'RA', 'LastName': 'Littlewood', 'Affiliation': 'Mind Research Network and Lovelace Biomedical and Environmental Research Institute, Albuquerque, NM, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mickey', 'Affiliation': 'Mind Research Network and Lovelace Biomedical and Environmental Research Institute, Albuquerque, NM, USA.'}, {'ForeName': 'Pamela B', 'Initials': 'PB', 'LastName': 'Arenella', 'Affiliation': 'Department of Psychiatry, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Goodreau', 'Affiliation': 'Mind Research Network and Lovelace Biomedical and Environmental Research Institute, Albuquerque, NM, USA.'}, {'ForeName': 'Kent E', 'Initials': 'KE', 'LastName': 'Hutchison', 'Affiliation': 'Mind Research Network and Lovelace Biomedical and Environmental Research Institute, Albuquerque, NM, USA.'}]",Addiction biology,['10.1111/adb.12498']
1207,31708151,"Safety and effectiveness of intravenous iron sucrose versus standard oral iron therapy in pregnant women with moderate-to-severe anaemia in India: a multicentre, open-label, phase 3, randomised, controlled trial.","BACKGROUND


Intravenous iron sucrose is a promising therapy for increasing haemoglobin concentration; however, its effect on clinical outcomes in pregnancy is not yet established. We aimed to assess the safety and clinical effectiveness of intravenous iron sucrose (intervention) versus standard oral iron (control) therapy in the treatment of women with moderate-to-severe iron deficiency anaemia in pregnancy.
METHODS


We did a multicentre, open-label, phase 3, randomised, controlled trial at four government medical colleges in India. Pregnant women, aged 18 years or older, at 20-28 weeks of gestation with a haemoglobin concentration of 5-8 g/dL, or at 29-32 weeks of gestation with a haemoglobin concentration of 5-9 g/dL, were randomly assigned (1:1) to receive intravenous iron sucrose (dose was calculated using a formula based on bodyweight and haemoglobin deficit) or standard oral iron therapy (100 mg elemental iron twice daily). Logistic regression was used to compare the primary maternal composite outcome consisting of potentially life-threatening conditions during peripartum and postpartum periods (postpartum haemorrhage, the need for blood transfusion during and after delivery, puerperal sepsis, shock, prolonged hospital stay [>3 days following vaginal delivery and >7 days after lower segment caesarean section], and intensive care unit admission or referral to higher centres) adjusted for site and severity of anaemia. The primary outcome was analysed in a modified intention-to-treat population, which excluded participants who refused to participate after randomisation, those who were lost to follow-up, and those whose outcome data were missing. Safety was assessed in both modified intention-to-treat and as-treated populations. The data safety monitoring board recommended stopping the trial after the first interim analysis because of futility (conditional power 1·14% under the null effects, 3·0% under the continued effects, and 44·83% under hypothesised effects). This trial is registered with the Clinical Trial Registry of India, CTRI/2012/05/002626.
FINDINGS


Between Jan 31, 2014, and July 31, 2017, 2018 women were enrolled, and 999 were randomly assigned to the intravenous iron sucrose group and 1019 to the standard therapy group. The primary maternal composite outcome was reported in 89 (9%) of 958 patients in the intravenous iron sucrose group and in 95 (10%) of 976 patients in the standard therapy group (adjusted odds ratio 0·95, 95% CI 0·70-1·29). 16 (2%) of 958 women in the intravenous iron sucrose group and 13 (1%) of 976 women in the standard therapy group had serious maternal adverse events. Serious fetal and neonatal adverse events were reported by 39 (4%) of 961 women in the intravenous iron sucrose group and 45 (5%) of 982 women in the standard therapy group. At 6 weeks post-randomisation, minor side-effects were reported by 117 (16%) of 737 women in the intravenous iron sucrose group versus 155 (21%) of 721 women in the standard therapy group. None of the serious adverse events was found to be related to the trial procedures or the interventions as per the causality assessment made by the trial investigators, ethics committees, and regulatory body.
INTERPRETATION


The study was stopped due to futility. There is insufficient evidence to show the effectiveness of intravenous iron sucrose in reducing clinical outcomes compared with standard oral iron therapy in pregnant women with moderate-to-severe anaemia.
FUNDING


WHO, India.",2019,"None of the serious adverse events was found to be related to the trial procedures or the interventions as per the causality assessment made by the trial investigators, ethics committees, and regulatory body.
","['958 women in the', 'pregnant women with moderate-to-severe anaemia in India', 'women with moderate-to-severe iron deficiency anaemia in pregnancy', '961 women in the', '737 women in the', 'Between Jan 31, 2014, and July 31, 2017, 2018', 'four government medical colleges in India', 'Pregnant women, aged 18 years or older, at 20-28 weeks of gestation with a haemoglobin concentration of 5-8 g/dL, or at 29-32 weeks of gestation with a haemoglobin concentration of 5-9 g/dL', 'pregnant women with moderate-to-severe anaemia']","['intravenous iron sucrose versus standard oral iron therapy', 'intravenous iron sucrose', 'standard oral iron therapy', 'intravenous iron sucrose (dose was calculated using a formula based on bodyweight and haemoglobin deficit) or standard oral iron therapy', 'intravenous iron sucrose (intervention) versus standard oral iron (control) therapy']","['Safety', 'modified intention-to-treat population', 'serious maternal adverse events', 'potentially life-threatening conditions during peripartum and postpartum periods (postpartum haemorrhage, the need for blood transfusion during and after delivery, puerperal sepsis, shock, prolonged hospital stay [>3 days following vaginal delivery and >7 days after lower segment caesarean section], and intensive care unit admission or referral to higher centres) adjusted for site and severity of anaemia', 'Serious fetal and neonatal adverse events', 'safety and clinical effectiveness', 'Safety and effectiveness']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C1318217', 'cui_str': '8G'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0060241', 'cui_str': 'iron saccharate'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1444752', 'cui_str': 'Status during (qualifier value)'}, {'cui': 'C2936491', 'cui_str': 'Peripartum'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0032797', 'cui_str': 'Postpartum Hemorrhage'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0269936', 'cui_str': 'Postpartum Sepsis'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0195620', 'cui_str': 'Low cervical cesarean section (procedure)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",982.0,0.316237,"None of the serious adverse events was found to be related to the trial procedures or the interventions as per the causality assessment made by the trial investigators, ethics committees, and regulatory body.
","[{'ForeName': 'Sutapa B', 'Initials': 'SB', 'LastName': 'Neogi', 'Affiliation': 'Indian Institute of Public Health-Delhi, Public Health Foundation of India, Gurgaon, India. Electronic address: sutapa.bneogi@iiphd.org.'}, {'ForeName': 'Niveditha', 'Initials': 'N', 'LastName': 'Devasenapathy', 'Affiliation': 'Indian Institute of Public Health-Delhi, Public Health Foundation of India, Gurgaon, India.'}, {'ForeName': 'Ranjana', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Indian Institute of Public Health-Delhi, Public Health Foundation of India, Gurgaon, India.'}, {'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Bhushan', 'Affiliation': 'National Health Systems Resource Centre, New Delhi, India.'}, {'ForeName': 'Duru', 'Initials': 'D', 'LastName': 'Shah', 'Affiliation': 'Breach Candy Hospital, Mumbai, India; Indian College of Obstetricians and Gynaecologists, Federation of Obstetrics and Gynaecology Society of India, Mumbai, India.'}, {'ForeName': 'Hema', 'Initials': 'H', 'LastName': 'Divakar', 'Affiliation': ""Divakar's Speciality Hospital, Bangalore, India.""}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Zodpey', 'Affiliation': 'Indian Institute of Public Health-Delhi, Public Health Foundation of India, Gurgaon, India.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Malik', 'Affiliation': 'Department of Obstetrics and Gynaecology, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Smiti', 'Initials': 'S', 'LastName': 'Nanda', 'Affiliation': 'Department of Obstetrics and Gynaecology, Pt Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences (PGIMS), Rohtak, India.'}, {'ForeName': 'Pratima', 'Initials': 'P', 'LastName': 'Mittal', 'Affiliation': 'Department of Obstetrics and Gynaecology, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Achla', 'Initials': 'A', 'LastName': 'Batra', 'Affiliation': 'Department of Obstetrics and Gynaecology, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Meenakshi B', 'Initials': 'MB', 'LastName': 'Chauhan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Pt Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences (PGIMS), Rohtak, India.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Yadav', 'Affiliation': 'Department of Obstetrics and Gynaecology, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Dongre', 'Affiliation': 'Department of Obstetrics and Gynaecology, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Sumita', 'Initials': 'S', 'LastName': 'Saluja', 'Affiliation': 'Department of Hematology, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Vani', 'Initials': 'V', 'LastName': 'Malhotra', 'Affiliation': 'Department of Obstetrics and Gynaecology, Pt Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences (PGIMS), Rohtak, India.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Department of Obstetrics and Gynaecology, Pt Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences (PGIMS), Rohtak, India.'}, {'ForeName': 'Roopa', 'Initials': 'R', 'LastName': 'Sangwan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Pt Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences (PGIMS), Rohtak, India.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Radhika', 'Affiliation': 'Department of Obstetrics and Gynaecology, Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Alpana', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Obstetrics and Gynaecology, Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Sruti', 'Initials': 'S', 'LastName': 'Bhaskaran', 'Affiliation': 'Department of Obstetrics and Gynaecology, Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Mrinalini', 'Initials': 'M', 'LastName': 'Kotru', 'Affiliation': 'Department of Pathology, Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Sikka', 'Affiliation': 'Department of Pathology, Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Sonika', 'Initials': 'S', 'LastName': 'Agarwal', 'Affiliation': 'Department of Obstetrics and Gynaecology, Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Francis', 'Affiliation': 'WHO, New Delhi, India.'}, {'ForeName': 'Kasonde', 'Initials': 'K', 'LastName': 'Mwingak', 'Affiliation': 'WHO, Kigali, Rwanda.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Baswal', 'Affiliation': 'Ministry of Health and Family Welfare, Government of India, New Delhi, India.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30427-9']
1208,30880176,"Glepaglutide, a novel long-acting glucagon-like peptide-2 analogue, for patients with short bowel syndrome: a randomised phase 2 trial.","BACKGROUND


Patients with short bowel syndrome might have impaired postprandial endogenous glucagon-like peptide-2 (GLP-2) secretion, which is required for optimal intestinal adaptation. We aimed to assess the therapeutic potential of glepaglutide, a novel long-acting GLP-2 analogue, for reducing faecal output and increasing intestinal absorption in patients with short bowel syndrome.
METHODS


In this single-centre, double-blind, crossover, randomised phase 2 trial, adults (aged ≥18 to ≤90 years) with short bowel syndrome and with a faecal wet weight output of 1500 g/day or more were randomly assigned to receive one of six dose sequences of glepaglutide (10 mg, 1 mg; 10 mg, 0·1 mg; 1 mg, 10 mg; 1 mg, 0·1 mg; 0·1 mg, 10 mg; or 0·1 mg, 1 mg). Patients received daily subcutaneous injections of the first assigned dose of glepaglutide for 3 weeks, followed by a washout period of 4-8 weeks, and then the second dose of glepaglutide for 3 weeks. An unmasked statistician generated the randomisation list, and the trial investigator enrolled patients and assigned them their patient numbers. Trial investigators, patients, and other care providers were masked throughout the trial. The primary endpoint was the absolute change from baseline in faecal wet weight output, measured separately over the two treatment periods. Metabolic balance studies were done before and after each treatment period to assess the primary endpoint. Per-protocol analysis was used to assess the efficacy. Safety analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, number NCT02690025, and has completed.
FINDINGS


Of the 22 patients screened between Feb 5, 2016, and Jan 25, 2017, 18 patients were randomly assigned and treated with glepaglutide; 16 patients completed the trial. Treatment with 1 mg and 10 mg glepaglutide changed the adjusted mean faecal output by -592 g/day (95% CI -913 to -272; p=0·002) and -833 g/day (-1152 to -515; p=0·0002) from baseline, respectively. No changes were observed with 0·1 mg glepaglutide. Of the 18 patients who were randomly assigned to treatment, common treatment-related adverse events were stoma complications (13 [72%] patients), injection site reactions (11 [61%]), peripheral oedema (ten [56%]), nausea and abdominal pain (eight [44%] each), polyuria and fatigue (six [33%] each), abdominal distention, vomiting, and dizziness (five [28%] each); and cough and decreased appetite (four [22%] each). Related or possibly related serious adverse events were reported in two patients in the 0·1 mg dose group and two patients in the 10 mg dose group. These events included abdominal pain, stoma obstruction, catheter-related sepsis, and infection of unknown origin. No patients died during the trial.
INTERPRETATION


Glepaglutide was well tolerated, and was associated with improved intestinal absorption in patients with short bowel syndrome with 1 mg and 10 mg glepaglutide, but not with 0·1 mg glepaglutide. Larger phase 3 clinical trials of longer durations have been initiated to fully assess the safety and efficacy of glepaglutide.
FUNDING


Zealand Pharma.",2019,Related or possibly related serious adverse events were reported in two patients in the 0·1 mg dose group and two patients in the 10 mg dose group.,"['Patients with short bowel syndrome', 'adults (aged ≥18 to ≤90 years) with short bowel syndrome and with a faecal wet weight output of 1500 g/day or more', '18 patients', '22 patients screened between Feb 5, 2016, and Jan 25, 2017, 18 patients', 'patients with short bowel syndrome', '16 patients completed the trial']","['glepaglutide', 'Glepaglutide, a novel long-acting glucagon-like peptide-2 analogue']","['polyuria and fatigue', 'cough and decreased appetite', 'abdominal pain, stoma obstruction, catheter-related sepsis, and infection of unknown origin', 'nausea and abdominal pain', 'injection site reactions', 'adjusted mean faecal output', 'absolute change from baseline in faecal wet weight output', 'abdominal distention, vomiting, and dizziness', 'peripheral oedema', 'intestinal absorption']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036992', 'cui_str': 'Short Bowel Syndrome'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0439417', 'cui_str': 'g/day'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0912332', 'cui_str': 'Proglucagon (126-158)'}]","[{'cui': 'C0032617', 'cui_str': 'Polyuria'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C3805041', 'cui_str': 'Stoma obstruction'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0439659', 'cui_str': 'Origins (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen (finding)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema (morphologic abnormality)'}, {'cui': 'C0021826', 'cui_str': 'Intestinal Absorption'}]",18.0,0.381207,Related or possibly related serious adverse events were reported in two patients in the 0·1 mg dose group and two patients in the 10 mg dose group.,"[{'ForeName': 'Rahim M', 'Initials': 'RM', 'LastName': 'Naimi', 'Affiliation': 'Department of Medical Gastroenterology and Hepatology, Rigshospitalet, Copenhagen, Denmark. Electronic address: rahim.mohammad.naimi@regionh.dk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hvistendahl', 'Affiliation': 'Department of Medical Gastroenterology and Hepatology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lotte H', 'Initials': 'LH', 'LastName': 'Enevoldsen', 'Affiliation': 'Department of Clinical Physiology, Nuclear Medicine, and PET, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jan L', 'Initials': 'JL', 'LastName': 'Madsen', 'Affiliation': 'Department of Clinical Physiology and Nuclear Medicine, Centre for Functional and Diagnostic Imaging and Research, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Fuglsang', 'Affiliation': 'Department of Clinical Physiology and Nuclear Medicine, Centre for Functional and Diagnostic Imaging and Research, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Steen S', 'Initials': 'SS', 'LastName': 'Poulsen', 'Affiliation': 'Department of Biomedical Sciences, The Panum Institute, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hannelouise', 'Initials': 'H', 'LastName': 'Kissow', 'Affiliation': 'Novo Nordisk Foundation Centre of Basic Metabolic Research and Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Pedersen', 'Affiliation': 'Novo Nordisk Foundation Centre of Basic Metabolic Research and Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nikolaj', 'Initials': 'N', 'LastName': 'Nerup', 'Affiliation': 'Department of Surgical Gastroenterology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Rikard', 'Initials': 'R', 'LastName': 'Ambrus', 'Affiliation': 'Department of Surgical Gastroenterology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Achiam', 'Affiliation': 'Department of Surgical Gastroenterology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lars B', 'Initials': 'LB', 'LastName': 'Svendsen', 'Affiliation': 'Department of Surgical Gastroenterology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Novo Nordisk Foundation Centre of Basic Metabolic Research and Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Novo Nordisk Foundation Centre of Basic Metabolic Research and Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Svend H', 'Initials': 'SH', 'LastName': 'Hansen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lars O', 'Initials': 'LO', 'LastName': 'Dragsted', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Steensberg', 'Affiliation': 'Research and Development, Zealand Pharma, Glostrup, Denmark.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Mouritzen', 'Affiliation': 'Research and Development, Zealand Pharma, Glostrup, Denmark.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Hansen', 'Affiliation': 'Research and Development, Zealand Pharma, Glostrup, Denmark.'}, {'ForeName': 'Palle B', 'Initials': 'PB', 'LastName': 'Jeppesen', 'Affiliation': 'Department of Medical Gastroenterology and Hepatology, Rigshospitalet, Copenhagen, Denmark.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30077-9']
1209,30898609,Alirocumab in Patients With Polyvascular Disease and Recent Acute Coronary Syndrome: ODYSSEY OUTCOMES Trial.,"BACKGROUND


Patients with acute coronary syndrome (ACS) and concomitant noncoronary atherosclerosis have a high risk of major adverse cardiovascular events (MACEs) and death. The impact of lipid lowering by proprotein convertase subtilisin-kexin type 9 inhibition in such patients is undetermined.
OBJECTIVES


This pre-specified analysis from ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) determined whether polyvascular disease influenced risks of MACEs and death and their modification by alirocumab in patients with recent ACS and dyslipidemia despite intensive statin therapy.
METHODS


Patients were randomized to alirocumab or placebo 1 to 12 months after ACS. The primary MACEs endpoint was the composite of coronary heart disease death, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization. All-cause death was a secondary endpoint.
RESULTS


Median follow-up was 2.8 years. Of 18,924 patients, 17,370 had monovascular (coronary) disease, 1,405 had polyvascular disease in 2 beds (coronary and peripheral artery or cerebrovascular), and 149 had polyvascular disease in 3 beds (coronary, peripheral artery, cerebrovascular). With placebo, the incidence of MACEs by respective vascular categories was 10.0%, 22.2%, and 39.7%. With alirocumab, the corresponding absolute risk reduction was 1.4% (95% confidence interval [CI]: 0.6% to 2.3%), 1.9% (95% CI: -2.4% to 6.2%), and 13.0% (95% CI: -2.0% to 28.0%). With placebo, the incidence of death by respective vascular categories was 3.5%, 10.0%, and 21.8%; the absolute risk reduction with alirocumab was 0.4% (95% CI: -0.1% to 1.0%), 1.3% (95% CI: -1.8% to 4.3%), and 16.2% (95% CI: 5.5% to 26.8%).
CONCLUSIONS


In patients with recent ACS and dyslipidemia despite intensive statin therapy, polyvascular disease is associated with high risks of MACEs and death. The large absolute reductions in those risks with alirocumab are a potential benefit for these patients. (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab [ODYSSEY OUTCOMES]: NCT01663402).",2019,"With alirocumab, corresponding absolute risk reduction (ARR [95% confidence interval]) was 1.4% (0.6, 2.3), 1.9% (-2.4%, 6.2%), and 13.0% (-2.0, 28.0).","['Patients with Recent Acute Coronary Syndrome and Polyvascular Disease', 'Patients with acute coronary syndrome (ACS', 'patients with recent ACS and dyslipidemia despite intensive statin therapy', 'patients with recent ACS and dyslipidemia despite intensive statin therapy, polyVD', 'Patients', '18,924 patients, 17,370 had monovascular (coronary) disease, 1,405 had polyVD in two beds (coronary and peripheral artery or cerebrovascular), and 149 had polyVD in three beds (coronary, peripheral artery, cerebrovascular']","['alirocumab', 'lipid-lowering by proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibition', 'placebo', 'alirocumab or placebo', 'Alirocumab']","['composite of coronary heart disease death, nonfatal myocardial infarction, fatal/nonfatal ischemic stroke, or unstable angina requiring hospitalization', 'incidence of death by respective vascular categories', 'incidence of MACE by respective vascular categories']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1100660', 'cui_str': 'Proprotein Convertases'}, {'cui': 'C0038601', 'cui_str': 'Subtilisins'}, {'cui': 'C0165249', 'cui_str': 'kexin protein, S cerevisiae'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}]",18924.0,0.26158,"With alirocumab, corresponding absolute risk reduction (ARR [95% confidence interval]) was 1.4% (0.6, 2.3), 1.9% (-2.4%, 6.2%), and 13.0% (-2.0, 28.0).","[{'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: j.w.jukema@lumc.nl.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'State University of New York, Downstate School of Public Health, Brooklyn, New York.'}, {'ForeName': 'Laurien E', 'Initials': 'LE', 'LastName': 'Zijlstra', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'H Asita', 'Initials': 'HA', 'LastName': 'de Silva', 'Affiliation': 'Clinical Trials Unit, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Latinoamerican Cardiological Studies, Cardiovascular Institute of Rosario, Rosario, Argentina.'}, {'ForeName': 'Jay M', 'Initials': 'JM', 'LastName': 'Edelberg', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada; St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Hanotin', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Harrington', 'Affiliation': 'Stanford Center for Clinical Research, Department of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Karpov', 'Affiliation': 'Russian Cardiological Scientific-Productive Complex, Moscow, Russian Federation.'}, {'ForeName': 'Angèle', 'Initials': 'A', 'LastName': 'Moryusef', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Prieto', 'Affiliation': 'University of Chile Clinical Hospital, Santiago, Chile.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina; Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Paris and Paris Diderot University, Sorbonne Paris Cité, FACT (French Alliance for Cardiovascular Trials), INSERM U1148, Paris, France; National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.03.013']
1210,30892782,Total cerebrovascular blood flow and whole brain perfusion in children sedated using propofol with or without ketamine at induction: An investigation with 2D-Cine PC and ASL.,"BACKGROUND


Multiple sedation regimes may be used to facilitate pediatric MRI scans. These regimes might affect cerebral blood flow and hemodynamics to varying degrees, particularly in children who may be vulnerable to anesthetic side effects.
PURPOSE


To compare the effects of propofol monosedation solely (Pm group) vs. a combination of propofol and ketamine (KP group) on brain hemodynamics and perfusion.
STUDY TYPE


Prospective double-blind randomized trial.
FIELD STRENGTH/SEQUENCES


1.5T and 3T. 2D-Cine phase contrast (2D-Cine PC) and pseudocontinuous arterial spin labeling (ASL).
POPULATION


Children aged from 3 months to 10 years referred for MRI with deep sedation were randomized into either the KP or the Pm group. Perfusion images were acquired with ASL followed by single-slice 2D-Cine PC acquired between the cervical vertebra C2 and C3.
ASSESSMENT


Average whole-brain perfusion (WBP ml.min -1  .100 ml -1  ) was extracted from the ASL perfusion maps and total cerebrovascular blood flow (CVF) was quantified by bilaterally summing the flow in the vertebral and the internal carotid arteries. The CVF values were converted to units of ml.min -1  .100 g -1  to calculate the tissue CVF 100g  (ml.min -1  .100 g -1  ). Images were assessed by a neuroradiologist and data from n = 81 (ASL) and n = 55 (PC) cases with no apparent pathology were entered into the analysis.
STATISTICAL TESTS


Multivariate analysis of covariance was performed to compare drug sedation effects on WBP, CVF, and CVF 100g  .
RESULTS


No significant difference in arterial flow was observed (P = 0.57), but the KP group showed significantly higher WBP than the Pm group, covarying for scanner and age (P = 0.003). A correlation analysis showed a significant positive correlation between mean WBP (ml.min -1  .100 g -1  ) and mean CVF 100g  .
DATA CONCLUSION


The KP group showed higher perfusion but no significant difference in vascular flow compared with the Pm group. WBP and CVF 100g  correlated significantly, but ASL appeared to have more susceptibility to perfusion differences arising from the different sedation regimes.
LEVEL OF EVIDENCE


1 Technical Efficacy: Stage 4 J. Magn. Reson. Imaging 2019;50:1433-1440.",2019,"No significant difference in arterial flow was observed (P = 0.57), but the KP group showed significantly higher WBP than the Pm group, covarying for scanner and age (P = 0.003).","['Children Sedated Using', 'at Induction', 'Children aged from 3\u2009months to 10\u2009years referred for MRI with deep sedation']","['KP', 'propofol and ketamine (KP group', 'pseudocontinuous arterial spin labeling (ASL', 'propofol', 'Propofol With or Without Ketamine']","['CVF values', 'vascular flow', 'Total Cerebrovascular Blood Flow and Whole Brain Perfusion', 'total cerebrovascular blood flow (CVF', 'WBP', 'brain hemodynamics and perfusion', 'mean WBP', 'arterial flow']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1956064', 'cui_str': 'Deep Sedation'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0429856', 'cui_str': 'Arterial flow (observable entity)'}]",,0.0329544,"No significant difference in arterial flow was observed (P = 0.57), but the KP group showed significantly higher WBP than the Pm group, covarying for scanner and age (P = 0.003).","[{'ForeName': 'Malek I', 'Initials': 'MI', 'LastName': 'Makki', 'Affiliation': ""MRI Research Center, University Children's Hospital, Zurich, Switzerland.""}, {'ForeName': 'Ruth L', 'Initials': 'RL', 'LastName': ""O'Gorman"", 'Affiliation': ""MRI Research Center, University Children's Hospital, Zurich, Switzerland.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Buhler', 'Affiliation': 'Anesthesia, University Children Hospital, Zurich, Switzerland.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Baledent', 'Affiliation': 'BioFlow Image, CHU Amiens Picardie, Amiens, France.'}, {'ForeName': 'Christian J', 'Initials': 'CJ', 'LastName': 'Kellenberger', 'Affiliation': ""Children's Research Center, University Children's Hospital, Zurich, Switzerland.""}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Sabandal', 'Affiliation': ""Children's Research Center, University Children's Hospital, Zurich, Switzerland.""}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': ""Children's Research Center, University Children's Hospital, Zurich, Switzerland.""}, {'ForeName': 'Ianina', 'Initials': 'I', 'LastName': 'Scheer', 'Affiliation': ""Children's Research Center, University Children's Hospital, Zurich, Switzerland.""}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Schmitz', 'Affiliation': ""Children's Research Center, University Children's Hospital, Zurich, Switzerland.""}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.26725']
1211,30854721,"Comments on the paper by Nielsen et al. entitled ""Intraoperative S-ketamine for the reduction of opioid consumption and pain one year after spine surgery: A randomized clinical trial of opioid-dependent patients"".",,2019,,"['dependent patients', 'after spine surgery']","['entitled ""Intraoperative S-ketamine', 'opioid']",['opioid consumption and pain one year'],"[{'cui': 'C0581116', 'cui_str': 'Dependent patient (finding)'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4082117', 'cui_str': 'One year'}]",,0.0997881,,"[{'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesiology, Changzheng Hospital, Shanghai, China.'}, {'ForeName': 'Ni', 'Initials': 'N', 'LastName': 'An', 'Affiliation': 'Department of Anaesthesiology, Changzheng Hospital, Shanghai, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Anaesthesiology, Changzheng Hospital, Shanghai, China.'}, {'ForeName': 'Hongbin', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Department of Anaesthesiology, Changzheng Hospital, Shanghai, China.'}]","European journal of pain (London, England)",['10.1002/ejp.1394']
1212,31488260,Effectiveness of a self-management programme in the treatment of antivitamin K oral anticoagulants. A feasibility study.,"BACKGROUND AND OBJECTIVES


To compare the efficacy of a self-monitoring programme vs. the conventional method used before the intervention in maintaining the international normalised ratio (INR) in the therapeutic range in patients receiving oral anticoagulants, as well as complications, quality of life and the time invested in the tests.
PATIENTS AND METHODS


Pre-pospilot and feasibility study. The study included 15 patients over the age of 18 years who had been attending the monitoring programme for more than 6months. In the pre phase, patients performed the tests and follow-up in the outpatient clinic. After conducting an individual training session with each patient to teach them how to perform venipuncture, use the coagulometer, manage dosing tables and subsequent follow-up from the virtual clinic, we compared the percentage of in-range INR tests, complications, quality of life, and the time invested in performing the tests pre- (conventional) and post-intervention (intervention for self-monitoring).
RESULTS


The percentage of INR tests in the therapeutic range was significantly higher in the post-phase than in the pre-phase (65.6% vs. 37.8%, p<.001). Likewise, the incidence of both minor and serious complications decreased in the post-phase (20% vs. 0%, and 6.7% vs. 0%, respectively). Finally, all 5dimensions of the quality of life questionnaire improved significantly, while the time invested decreased.
CONCLUSIONS


In our experience, OAT self-monitoring is associated with a significant improvement in patient management, a reduction in the rate of complications, improved quality of life and timesaving.",2020,"The percentage of INR tests in the therapeutic range was significantly higher in the post-phase than in the pre-phase (65.6% vs. 37.8%, p<.001).","['15 patients over the age of 18 years who had been attending the monitoring programme for more than 6months', 'patients receiving oral anticoagulants']","['conventional) and post-intervention', 'self-management programme']","['incidence of both minor and serious complications', 'quality of life questionnaire', 'rate of complications, improved quality of life and timesaving', 'percentage of INR tests']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0525032', 'cui_str': 'INR'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.0260948,"The percentage of INR tests in the therapeutic range was significantly higher in the post-phase than in the pre-phase (65.6% vs. 37.8%, p<.001).","[{'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Vall Vargas', 'Affiliation': 'Departamento de Hematología, Althaia-Xarxa Assistencial Universitària de Manresa, Manresa, Barcelona, España. Electronic address: avall@althaia.cat.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Altes Hernandez', 'Affiliation': 'Departamento de Hematología, Althaia-Xarxa Assistencial Universitària de Manresa, Manresa, Barcelona, España.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Arnau', 'Affiliation': 'Departamento de Investigación e Innovación, Althaia-Xarxa Assistencial Universitària de Manresa, Manresa, Barcelona, España.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Constans Cots', 'Affiliation': 'Departamento de Hematología, Althaia-Xarxa Assistencial Universitària de Manresa, Manresa, Barcelona, España.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Gallart Fernández-Puebla', 'Affiliation': 'Departamento de Enfermería, Facultad de Medicina y Ciencias de la Salud, Universitat Internacional de Catalunya, Barcelona, Grupo de Investigación Emergente en Educación en Salud UICBarcelona, 2017 SGR 141.'}, {'ForeName': 'María Ángeles', 'Initials': 'MÁ', 'LastName': 'de Juan Pardo', 'Affiliation': 'Departamento de Enfermería, Facultad de Medicina y Ciencias de la Salud, Universitat Internacional de Catalunya, Barcelona, Grupo de Investigación Emergente en Educación en Salud UICBarcelona, 2017 SGR 141.'}]",Medicina clinica,['10.1016/j.medcli.2019.06.016']
1213,27808528,Avoidant coping and diabetes-related distress: Pathways to adolescents' Type 1 diabetes outcomes.,"OBJECTIVE


Adolescents with Type 1 diabetes (T1D) are vulnerable to diabetes-related distress and often struggle to complete self-management tasks needed to maintain blood glucose values in target range. One way that youth with T1D handle problems is through avoidant coping. The current study examined cross-time associations between avoidant coping style and diabetes outcomes and tested the possible mediating role of diabetes-related distress.
METHOD


Adolescents with T1D (N = 264) were assessed 4 times over 1 year to measure avoidant coping style, diabetes-related distress, adherence (on the basis of glucometer data and self-report), and glycemic control (hemoglobin A1c). Mediation and direct effects were tested across time using time-lagged autoregressive path models, making use of the repeated measurement of all constructs.
RESULTS


The hypothesized mediation effect was found for all 3 diabetes outcomes. Higher levels of avoidant coping style were associated with greater diabetes-related distress at the subsequent time point, which was related in turn to fewer blood glucose checks, less frequent self-care behaviors, and poorer glycemic control (higher A1c) at the next assessment.
CONCLUSIONS


In the context of diabetes, an avoidant coping style may contribute to greater diabetes-specific distress followed by deterioration in self-management and glycemic control over time. Maladaptive coping styles are modifiable factors that offer an entry point into intervention before further difficulties can take hold. (PsycINFO Database Record",2017,"Higher levels of avoidant coping style were associated with greater diabetes-related distress at the subsequent time point, which was related in turn to fewer blood glucose checks, less frequent self-care behaviors, and poorer glycemic control (higher A1c) at the next assessment.
","['Adolescents with T1D (N = 264', 'Adolescents with Type 1 diabetes (T1D']",[],"['Higher levels of avoidant coping style', 'Avoidant coping and diabetes-related distress', 'blood glucose checks, less frequent self-care behaviors, and poorer glycemic control', 'avoidant coping style, diabetes-related distress, adherence (on the basis of glucometer data and self-report), and glycemic control (hemoglobin A1c']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}, {'cui': 'C0342299', 'cui_str': 'Poor glycemic control (disorder)'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}]",264.0,0.0137314,"Higher levels of avoidant coping style were associated with greater diabetes-related distress at the subsequent time point, which was related in turn to fewer blood glucose checks, less frequent self-care behaviors, and poorer glycemic control (higher A1c) at the next assessment.
","[{'ForeName': 'Esti', 'Initials': 'E', 'LastName': 'Iturralde', 'Affiliation': 'Department of Pediatrics, Stanford University School of Medicine.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Weissberg-Benchell', 'Affiliation': ""Northwestern University Feinberg School of Medicine/Ann and Robert H. Lurie Children's Hospital of Chicago.""}, {'ForeName': 'Korey K', 'Initials': 'KK', 'LastName': 'Hood', 'Affiliation': 'Department of Pediatrics, Stanford University School of Medicine.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000445']
1214,30897584,Effect of EP1 Receptor Antagonist on Transient Lower Esophageal Sphincter Relaxations in Humans.,"BACKGROUND/AIMS


Transient lower esophageal sphincter relaxations (TLESRs) are the major cause of gastroesophageal reflux. Recently, an EP1 receptor antagonist, ONO-8539, showed the reduction of TLESRs in monkeys. However, its effect on TLESRs in humans remains unclear. This study investigated the effect of ONO-8539 on postprandial TLESRs in healthy male subjects.
METHODS


Twenty-seven subjects participated in this placebo-controlled, cross-over study. The subjects received either placebo or ONO-8539 (450 mg) after a standardized breakfast. A 30-min basal recording was performed 4 h after drug administration. Subsequently, TLESR recordings were performed after a high-fat test meal for 3 h. The examination was repeated at least 7 days from the first evaluation for washout.
RESULTS


Thirteen patients were ultimately analyzed. The basal lower esophageal sphincter pressure was not different between the 2 groups (16.3 and 18.0 mm Hg for placebo and ONO-8539, respectively; p = 0.88). ONO-8539 significantly reduced the number of TLESRs from 15.0 to 12.0 for 3 h (p < 0.05). The proportion of terminating events of TLESRs was significantly different between the 2 groups (p < 0.05). No events and swallowing terminated more TLESRs with ONO-8539 than with placebo.
CONCLUSIONS


ONO-8539 suppressed TLESRs mildly. EP1 receptor may be involved with the mechanism of human TLESRs.",2020,The proportion of terminating events of TLESRs was significantly different between the 2 groups (p < 0.05).,"['Twenty-seven subjects participated in this placebo-controlled, cross-over study', 'Thirteen patients were ultimately analyzed', 'Humans', 'healthy male subjects']","['ONO-8539', 'EP1 Receptor Antagonist', 'placebo or ONO-8539']","['number of TLESRs', 'Transient Lower Esophageal Sphincter Relaxations', 'proportion of terminating events of TLESRs', 'basal lower esophageal sphincter pressure']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0014865', 'cui_str': 'Esophageal sphincter (body structure)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",13.0,0.0851733,The proportion of terminating events of TLESRs was significantly different between the 2 groups (p < 0.05).,"[{'ForeName': 'Akinari', 'Initials': 'A', 'LastName': 'Sawada', 'Affiliation': 'Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan, m1164972@med.osaka-cu.ac.jp.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Uemura', 'Affiliation': 'Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Yamagami', 'Affiliation': 'Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Tanigawa', 'Affiliation': 'Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan.'}]",Digestion,['10.1159/000499333']
1215,30824364,Tuberculosis case detection by trained inmate peer educators in a resource-limited prison setting in Ethiopia: a cluster-randomised trial.,"BACKGROUND


To improve tuberculosis case detection, interventions that are feasible with available resources are needed. We investigated whether involving trained prison inmates in a tuberculosis control programme improved tuberculosis case detection, shortened pre-treatment symptom duration, and increased treatment success in a resource-limited prison setting in Ethiopia.
METHODS


In this cluster-randomised trial we randomly assigned prisons in the regions Amhara and Tigray of Ethiopia to an intervention group or a control group, after matching them into pairs based on their geographical proximity and size. Larger prisons were considered eligible whereas smaller prisons were excluded. We selected three to six prison inmates in each intervention prison. The recruited prison inmates who received a 3-day training course and were capable of identifying presumptive tuberculosis cases then provided health education to all other prison inmates about tuberculosis prevention and control every 2 weeks for 1 year. They also actively searched for symptomatic prison inmates and undertook routine symptom-based tuberculosis screening. The control prisons followed the existing passive case finding system. The primary outcome was the mean case detection rate at the end of the year, measured at cluster (prison) level. This trial is registered at ClinicalTrials.gov, number NCT02744521.
FINDINGS


We randomly assigned 16 prisons with a total population of 18 032 inmates to either the intervention group (n=8) or the control group (n=8) from April 1, 2016, to March 31, 2017. During the 1-year study period, 75 new tuberculosis cases (1% of 8874 total inmates) were detected in the intervention prisons and 25 new cases (<1% of 9158 total inmates) were detected in the control prisons. The mean case detection rate was significantly higher in the intervention group than in the control group (mean difference 52·9 percentage points, 95% CI 17·5-88·3, p=0·010).
INTERPRETATION


Involving trained inmate peer educators in the tuberculosis control programme in Ethiopian prisons significantly improved the tuberculosis case detection rate. The findings have important implications for clinical and public health policy, particularly in prisons of low-income countries where tuberculosis burden is high and the recommended tuberculosis diagnostic and treatment algorithms have generally not been implemented.
FUNDING


Nuffic, Mekelle University.",2019,"The mean case detection rate was significantly higher in the intervention group than in the control group (mean difference 52·9 percentage points, 95% CI 17·5-88·3, p=0·010).
","['recruited prison inmates who received a', '16 prisons with a total population of 18\u2008032 inmates to either the intervention group (n=8) or the control group (n=8) from April 1, 2016, to March 31, 2017', '75 new tuberculosis cases (1% of 8874 total inmates', 'Tuberculosis case detection by trained inmate peer educators in a resource-limited prison setting in Ethiopia', 'trained prison inmates', 'six prison inmates in each intervention prison']",['3-day training course and were capable of identifying presumptive tuberculosis cases then provided health education to all other prison inmates about tuberculosis prevention and control every 2 weeks for 1 year'],"['mean case detection rate at the end of the year, measured at cluster (prison) level', 'tuberculosis case detection', 'tuberculosis case detection rate', 'mean case detection rate']","[{'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0015024', 'cui_str': 'Federal Democratic Republic of Ethiopia'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0018701'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}]",16.0,0.209595,"The mean case detection rate was significantly higher in the intervention group than in the control group (mean difference 52·9 percentage points, 95% CI 17·5-88·3, p=0·010).
","[{'ForeName': 'Kelemework', 'Initials': 'K', 'LastName': 'Adane', 'Affiliation': 'Department of Medical Microbiology and Immunology, College of Health Sciences, Mekelle University, Mekelle, Ethiopia; Department of Family Medicine, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, Netherlands. Electronic address: ingoldmlt@gmail.com.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Spigt', 'Affiliation': 'Department of Family Medicine, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, Netherlands; Department of Community Medicine, General Practice Research Unit, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Winkens', 'Affiliation': 'Department of Methodology and Statistics, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Geert-Jan', 'Initials': 'GJ', 'LastName': 'Dinant', 'Affiliation': 'Department of Family Medicine, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, Netherlands.'}]",The Lancet. Global health,['10.1016/S2214-109X(18)30477-7']
1216,30185793,Individual and combined effects of acute delta-9-tetrahydrocannabinol and cannabidiol on psychotomimetic symptoms and memory function.,"The main active ingredient in cannabis, delta-9-tetrahydrocannabinol (THC), can acutely induce psychotic symptoms and impair episodic and working memory. Another major constituent, cannabidiol (CBD), may attenuate these effects. This study aimed to determine the effects of THC and CBD, both alone and in combination on psychotic symptoms and memory function. A randomised, double-blind crossover design compared the effects of (i) placebo, (ii) THC 8 mg, (iii) CBD 16 mg and (iv) THC 8 mg + CBD 16 mg administered by inhalation through a vaporiser. Using an experimental medicine approach to predict treatment sensitivity, we selected 48 cannabis users from the community on the basis of (1) schizotypal personality questionnaire scores (low, high) and (2) frequency of cannabis use (light, heavy). The Brief Psychiatric Rating Scale (BPRS), Psychotomimetic States Inventory (PSI), immediate and delayed prose recall (episodic memory), 1- and 2-back (working memory) were assessed on each day. Results indicated that THC increased overall scores on the PSI, negative symptoms on BPRS, and robustly impaired episodic and working memory. Co-administration of CBD did not attenuate these effects. CBD alone reduced PSI scores in light users only. At a ratio of 2:1, CBD does not attenuate the acute psychotic and memory impairing effects of vaporised THC. Frequent cannabis users may show a blunted anti- psychotic response to CBD, which is of concern due to the high rates of cannabis use disorders in patients with schizophrenia.",2018,"At a ratio of 2:1, CBD does not attenuate the acute psychotic and memory impairing effects of vaporised THC.","['48 cannabis users from the community on the basis of (1) schizotypal personality questionnaire scores (low, high) and (2) frequency of cannabis use (light, heavy', 'patients with schizophrenia']","['Co', 'THC', 'THC and CBD', 'placebo, (ii', 'CBD', 'acute delta-9-tetrahydrocannabinol and cannabidiol']","['psychotomimetic symptoms and memory function', 'PSI scores', 'psychotic symptoms and memory function', '1- and 2-back (working memory', 'psychotic symptoms and impair episodic and working memory', 'acute psychotic and memory impairing effects of vaporised THC', 'overall scores on the PSI, negative symptoms on BPRS, and robustly impaired episodic and working memory', 'Brief Psychiatric Rating Scale (BPRS), Psychotomimetic States Inventory (PSI), immediate and delayed prose recall (episodic memory']","[{'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0036363', 'cui_str': 'Schizotypal Personality Disorder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1706489', 'cui_str': 'Psi'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0233794', 'cui_str': 'Memory Deficits'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0029941', 'cui_str': 'Overall and Gorham Brief Psychiatric Rating Scale'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}]",48.0,0.253084,"At a ratio of 2:1, CBD does not attenuate the acute psychotic and memory impairing effects of vaporised THC.","[{'ForeName': 'Celia J A', 'Initials': 'CJA', 'LastName': 'Morgan', 'Affiliation': 'Psychopharmacology and Addiction Research Centre, University of Exeter, Exeter, UK. celia.morgan@exeter.ac.uk.'}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Freeman', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'Chandni', 'Initials': 'C', 'LastName': 'Hindocha', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'Grainne', 'Initials': 'G', 'LastName': 'Schafer', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Gardner', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'H Valerie', 'Initials': 'HV', 'LastName': 'Curran', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}]",Translational psychiatry,['10.1038/s41398-018-0191-x']
1217,30858014,"An environmental cleaning bundle and health-care-associated infections in hospitals (REACH): a multicentre, randomised trial.","BACKGROUND


The hospital environment is a reservoir for the transmission of microorganisms. The effect of improved cleaning on patient-centred outcomes remains unclear. We aimed to evaluate the effectiveness of an environmental cleaning bundle to reduce health care-associated infections in hospitals.
METHODS


The REACH study was a pragmatic, multicentre, randomised trial done in 11 acute care hospitals in Australia. Eligible hospitals had an intensive care unit, were classified by the National Health Performance Authority as a major hospital (public hospitals) or having more than 200 inpatient beds (private hospitals), and had a health-care-associated infection surveillance programme. The stepped-wedge design meant intervention periods varied from 20 weeks to 50 weeks. We introduced the REACH cleaning bundle, a multimodal intervention, focusing on optimising product use, technique, staff training, auditing with feedback, and communication, for routine cleaning. The primary outcomes were incidences of health-care-associated Staphylococcus aureus bacteraemia, Clostridium difficile infection, and vancomycin-resistant enterococci infection. The secondary outcome was the thoroughness of cleaning of frequent touch points, assessed by a fluorescent marking gel. This study is registered with the Australian and New Zealand Clinical Trial Registry, number ACTRN12615000325505.
FINDINGS


Between May 9, 2016, and July 30, 2017, we implemented the cleaning bundle in 11 hospitals. In the pre-intervention phase, there were 230 cases of vancomycin-resistant enterococci infection, 362 of S aureus bacteraemia, and 968 C difficile infections, for 3 534 439 occupied bed-days. During intervention, there were 50 cases of vancomycin-resistant enterococci infection, 109 of S aureus bacteraemia, and 278 C difficile infections, for 1 267 134 occupied bed-days. After the intervention, vancomycin-resistant enterococci infections reduced from 0·35 to 0·22 per 10 000 occupied bed-days (relative risk 0·63, 95% CI 0·41-0·97, p=0·0340). The incidences of S aureus bacteraemia (0·97 to 0·80 per 10 000 occupied bed-days; 0·82, 0·60-1·12, p=0·2180) and C difficile infections (2·34 to 2·52 per 10 000 occupied bed-days; 1·07, 0·88-1·30, p=0·4655) did not change significantly. The intervention increased the percentage of frequent touch points cleaned in bathrooms from 55% to 76% (odds ratio 2·07, 1·83-2·34, p<0·0001) and bedrooms from 64% to 86% (1·87, 1·68-2·09, p<0·0001).
INTERPRETATION


The REACH cleaning bundle was successful at improving cleaning thoroughness and showed great promise in reducing vancomycin-resistant enterococci infections. Our work will inform hospital cleaning policy and practice, highlighting the value of investment in both routine and discharge cleaning practice.
FUNDING


National Health and Medical Research Council (Australia).",2019,"occupied bed-days; 1·07, 0·88-1·30, p=0·4655) did not change significantly.","['hospitals (REACH', '11 acute care hospitals in Australia', 'hospitals', 'Eligible hospitals had an intensive care unit, were classified by the National Health Performance Authority as a major hospital (public hospitals) or having more than 200 inpatient beds (private hospitals), and had a health-care-associated infection surveillance programme', 'Between May 9, 2016, and July 30, 2017']",['environmental cleaning bundle'],"['incidences of S aureus bacteraemia', 'incidences of health-care-associated Staphylococcus aureus bacteraemia, Clostridium difficile infection, and vancomycin-resistant enterococci infection', 'percentage of frequent touch points cleaned', 'C difficile infections', 'vancomycin-resistant enterococci infections', 'thoroughness of cleaning of frequent touch points, assessed by a fluorescent marking gel']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C3661916', 'cui_str': 'Acute care hospital'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0033173', 'cui_str': 'Hospitals, Private'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0419786', 'cui_str': 'Infection surveillance (regime/therapy)'}]",[],"[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1142423', 'cui_str': 'Bacteremia caused by Staphylococcus aureus'}, {'cui': 'C0343386', 'cui_str': 'Clostridium difficile infection (disorder)'}, {'cui': 'C1265175', 'cui_str': 'Vancomycin-Resistant Enterococci'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]",,0.165914,"occupied bed-days; 1·07, 0·88-1·30, p=0·4655) did not change significantly.","[{'ForeName': 'Brett G', 'Initials': 'BG', 'LastName': 'Mitchell', 'Affiliation': 'Faculty of Nursing and Health, Avondale College, Wahroonga, NSW, Australia; School of Nursing and Midwifery, University of Newcastle, Newcastle, NSW, Australia. Electronic address: brett.mitchell@avondale.edu.au.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hall', 'Affiliation': 'School of Public Health, University of Queensland, Herston, QLD, Australia; School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'White', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, Australia; School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Adrian G', 'Initials': 'AG', 'LastName': 'Barnett', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, Australia; School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Halton', 'Affiliation': 'School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Paterson', 'Affiliation': ""University of Queensland Centre for Clinical Research, Royal Brisbane and Women's Hospital, Herston, QLD, Australia.""}, {'ForeName': 'Thomas V', 'Initials': 'TV', 'LastName': 'Riley', 'Affiliation': 'School of Biomedical Sciences, The University of Western Australia, Crawley, WA, Australia; School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia; School of Veterinary and Life Sciences, Murdoch University, Murdoch, WA, Australia; PathWest Laboratory Medicine, QEII Medical Centre, Nedlands, WA, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gardner', 'Affiliation': 'School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Page', 'Affiliation': 'School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Farrington', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, Australia; School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Gericke', 'Affiliation': 'School of Clinical Medicine, University of Queensland, Herston, QLD, Australia; College of Public Health, Medical and Veterinary Sciences and College of Medicine and Dentistry, James Cook University, Cairns, QLD, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Graves', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, Australia; School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30714-X']
1218,30859185,Pharmacokinetics of ascending doses of ivermectin in Trichuris trichiura-infected children aged 2-12 years.,"BACKGROUND


Yearly, millions of children are treated globally with ivermectin mainly for neglected tropical diseases. Anatomical, physiological and biochemical differences between children and adults may result in changes in pharmacokinetics. However, paediatric pharmacokinetic data of ivermectin are lacking.
METHODS


In the framework of a randomized controlled dose-finding trial in rural Côte d'Ivoire, Trichuris trichiura-infected pre-school-aged children (PSAC, 2-5 years) and school-aged children (SAC, 6-12 years) were assigned to 100 or 200 μg/kg and 200, 400 or 600 μg/kg ivermectin, respectively (ISRCTN registry no. ISRCTN15871729). Capillary blood was collected on dried blood spot cards until 72 h post-treatment. Ivermectin was quantified by LC-MS/MS, and pharmacokinetic parameters were evaluated by non-compartmental analysis.
RESULTS


C max and AUC increased in PSAC and SAC with ascending doses and were similar in both age groups when the current standard dose (200 μg/kg) was administered (∼23 ng/mL and ∼350 ng×h/mL, respectively). PSAC with lower BMI were associated with significantly higher AUCs. AUC and Cmax were ∼2-fold lower in children compared with parameters previously studied in adults, whereas body weight-adjusted CL/F (∼0.35 L/h/kg) was significantly higher in children. Tmax (∼6 h), t1/2 (∼18 h), mean residence time (MRTINF) (∼28 h) and V/F (∼8 L/kg) were similar in all paediatric treatment arms.
CONCLUSIONS


A positive association of AUC or Cmax with dose was observed in both age groups. Undernutrition might influence the AUC of ivermectin in PSAC. Ivermectin shows a lower exposure profile in children compared with adults, highlighting the need to establish dosing recommendations for different age groups.",2019,"RESULTS


C max and AUC increased in PSAC and SAC with ascending doses and were similar in both age groups when the current standard dose (200 μg/kg) was administered (∼23 ng/mL and ∼350 ng×h/mL, respectively).","['Trichuris trichiura-infected children aged 2-12 years', ""rural Côte d'Ivoire, Trichuris trichiura-infected pre-school-aged children (PSAC, 2-5\u2009years) and school-aged children (SAC, 6-12\u2009years""]","['Ivermectin', 'ivermectin']","['AUC and Cmax', 'Capillary blood', 'Tmax (∼6 h), t1/2 (∼18\u2009h), mean residence time (MRTINF) (∼28\u2009h) and V/F', 'C max and AUC increased in PSAC and SAC']","[{'cui': 'C0040913', 'cui_str': 'Trichuris trichiura'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0424930', 'cui_str': 'Pre-school (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}]","[{'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood (substance)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.325026,"RESULTS


C max and AUC increased in PSAC and SAC with ascending doses and were similar in both age groups when the current standard dose (200 μg/kg) was administered (∼23 ng/mL and ∼350 ng×h/mL, respectively).","[{'ForeName': 'Jessica D', 'Initials': 'JD', 'LastName': 'Schulz', 'Affiliation': 'Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Jean T', 'Initials': 'JT', 'LastName': 'Coulibaly', 'Affiliation': 'Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schindler', 'Affiliation': 'Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wimmersberger', 'Affiliation': 'Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Keiser', 'Affiliation': 'Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, Basel, Switzerland.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz083']
1219,30864528,Investigation of the Roles of New Antiepileptic Drugs and Serum BDNF Levels in Efficacy and Safety Monitoring and Quality of Life: A Clinical Research.,"OBJECTIVE


We aimed to determine the therapeutic drug monitoring (TDM) features and the relation to Brain-Derived Neurotrophic Factor (BDNF) of frequently used new antiepileptic drugs (NADs) including lamotrigine (LTG), oxcarbazepine (OXC), zonisamide (ZNS) and lacosamide (LCM). Moreover, we investigated their effect on the quality of life (QoL).
METHODS


Eighty epileptic patients who had been using the NADs, and thirteen healthy participants were included in this cross-sectional study. The participants were randomized into groups. The QOLIE-31 test was used for the assessment of QoL. We also prepared and applied ""Safety Test"". HPLC method for TDM, and ELISA method for BDNF measurements were used consecutively.
RESULTS


In comparison to healthy participants, epileptic participants had lower marriage rate (p=0.049), education level (p˂0.001), alcohol use (p=0.002). BDNF levels were higher in patients with focal epilepsy (p=0.013) and in those with higher education level (p=0.016). There were negative correlations between serum BDNF levels and serum ZNS levels (p=0.042) with LTGpolytherapy, serum MHD levels (a 10-monohydroxy derivative of OXC, p=0.041) with OXCmonotherapy. There was no difference in BDNF according to monotherapy-polytherapy, drugresistant groups, regarding seizure frequency. There was a positive correlation between total health status and QoL (p˂0.001). QOLIE-31 overall score (OS) was higher in those with OXCmonotherapy (76.5±14.5). OS (p˂0.001), seizure worry (SW, p=0.004), cognition (C, p˂0.001), social function (SF, p˂0.001) were different in the main groups. Forgetfulness was the most common unwanted effect.
CONCLUSION


While TDM helps the clinician to use more effective and safe NADs, BDNF may assist in TDM for reaching the therapeutic target in epilepsy.",2020,BDNF levels were higher in patients with focal epilepsy (p=0.013) and in those with higher education level (p=0.016).,"['Eighty epileptic patients who had been using the NAD, thirteen healthy participants were included in this cross-sectional study', 'Conclussion']","['OXC-monotherapy', 'lamotrigine (LTG), oxcarbazepine (OXC), zonisamide (ZNS) and lacosamide (LCM']","['marriage rate', 'serum MHD levels (10-monohydroxy derivative of OXC', 'BDNF', 'seizure worry (SW, p=0.004), cognition (C, p˂0.001), social function', 'total health status and QoL', 'QOLIE-31 overall score (OS', 'BDNF levels', 'quality of life (QoL', 'serum BDNF levels and serum ZNS levels', 'education level', 'efficacy and safety monitoring and quality of life']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0621630', 'cui_str': 'NAD(S)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0010362', 'cui_str': 'Disease Frequency Surveys'}]","[{'cui': 'C0064636', 'cui_str': 'lamotrigine'}, {'cui': 'C0069751', 'cui_str': 'oxcarbazepine'}, {'cui': 'C0078844', 'cui_str': 'zonisamide'}, {'cui': 'C0893761', 'cui_str': 'lacosamide'}]","[{'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",13.0,0.0902854,BDNF levels were higher in patients with focal epilepsy (p=0.013) and in those with higher education level (p=0.016).,"[{'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Demir', 'Affiliation': 'Department of Medical and Clinical Pharmacology, Istanbul Faculty of Medicine, Istanbul University, Fatih / Capa 34093, Istanbul, Turkey.'}, {'ForeName': 'Emel O', 'Initials': 'EO', 'LastName': 'Akarsu', 'Affiliation': 'Department of Neurology, Istanbul Faculty of Medicine, Istanbul University, Fatih / Capa 34093, Istanbul, Turkey.'}, {'ForeName': 'Hava O', 'Initials': 'HO', 'LastName': 'Dede', 'Affiliation': 'Department of Neurology, Istanbul Faculty of Medicine, Istanbul University, Fatih / Capa 34093, Istanbul, Turkey.'}, {'ForeName': 'Nerses', 'Initials': 'N', 'LastName': 'Bebek', 'Affiliation': 'Department of Neurology, Istanbul Faculty of Medicine, Istanbul University, Fatih / Capa 34093, Istanbul, Turkey.'}, {'ForeName': 'Sevda O', 'Initials': 'SO', 'LastName': 'Yıldız', 'Affiliation': 'Department of Biostatistics, Istanbul Faculty of Medicine, Istanbul University, Fatih / Capa 34093, Istanbul, Turkey.'}, {'ForeName': 'Betül', 'Initials': 'B', 'LastName': 'Baykan', 'Affiliation': 'Department of Neurology, Istanbul Faculty of Medicine, Istanbul University, Fatih / Capa 34093, Istanbul, Turkey.'}, {'ForeName': 'Ahmet G', 'Initials': 'AG', 'LastName': 'Akkan', 'Affiliation': 'Department of Medical and Clinical Pharmacology, Cerrahpasa Faculty of Medicine, Istanbul University, Cerrahpasa Street / Fatih 34093, Istanbul, Turkey.'}]",Current clinical pharmacology,['10.2174/1574884714666190312145409']
1220,30820517,Effect of Creatine Supplementation Dosing Strategies on Aging Muscle Performance.,"OBJECTIVE


This study compared the effects of different creatine supplementation dosages, independent of resistance training, on aging muscle performance and functionality.
DESIGN AND PARTICIPANTS


Using a double-blind, repeated measures design, participants were randomized to one of three groups: Creatine-High (CR-H; n=11; 0.3 g/kg/day of creatine + 0.1 g/kg/day of maltodextrin), Creatine-Moderate (CR-M: n=11; 0.1 g/kg/day of creatine + 0.3 g/kg/day of maltodextrin) or Placebo (PLA; n=11; 0.4 g/kg/day of maltodextrin) for 10 consecutive days.
MEASUREMENTS


The primary dependent variables measured at baseline and after supplementation included muscle strength (1-repetition maximum leg press, chest press, hand-grip), muscle endurance (leg press and chest press; maximal number of repetitions performed for 1 set at 80% and 70% baseline 1-repetition maximum respectively), and physical performance (dynamic balance).
RESULTS


There was a significant increase over time for muscle strength (Leg press: CR-H pre 161.5 ± 55.1 kg, post 169.2 ± 59.2 kg; CR-M pre 145.2 ± 47.7 kg, post 151.7 ± 45.0 kg; PLA pre 163.7 ± 51.5 kg, post 178.2 ± 65.6 kg, p = 0.001; Chest press: CR-H pre 57.0 ± 26.2 kg, post 58.8 ± 28.0 kg; CR-M pre 54.5 ± 27.9 kg, post 56.8 ± 30.1 kg; PLA pre 55.1 ± 26.9 kg, post 58.5 ± 30.1 kg, p = 0.001) and endurance (Leg press: CR-H pre 17.1 ± 6.0 reps, post 21.0 ± 7.2 reps; CR-M pre 24.1 ± 11.6 reps, post 29.1 ± 17.0 reps; PLA pre 23.8 ± 9.7 reps, post 29.5 ± 11.9 reps, p = 0. 001; Chest press: CR-H pre 15.6 ± 2.7 reps, post 18.9 ± 2.7 reps; CR-M pre 18.0 ± 5.0 reps, post 19.9 ± 7.1 reps; PLA pre 20.5 ± 6.2 reps, post 21.6 ± 5.5 reps, p = 0. 001), with no other differences.
CONCLUSION


Short-term creatine supplementation, independent of dosage and resistance training, has no effect on aging muscle performance.",2019,"There was a significant increase over time for muscle strength (Leg press: CR-H pre 161.5 ± 55.1 kg, post 169.2 ± 59.2 kg; CR-M pre 145.2 ± 47.7 kg, post 151.7 ± 45.0 kg; PLA pre 163.7 ± 51.5 kg, post 178.2 ± 65.6 kg, p = 0.001; Chest press: CR-H pre 57.0 ± 26.2 kg, post 58.8 ± 28.0 kg; CR-M pre 54.5 ± 27.9 kg, post 56.8 ± 30.1 kg; PLA pre 55.1 ± 26.9 kg, post 58.5 ± 30.1 kg, p = 0.001) and endurance (Leg press: CR-H pre 17.1 ± 6.0 reps, post 21.0 ± 7.2 reps; CR-M pre 24.1 ± 11.6 reps, post 29.1 ± 17.0 reps; PLA pre 23.8 ± 9.7 reps, post 29.5 ± 11.9 reps, p = 0.",[],"['Creatine-High (CR-H; n=11; 0.3 g/kg/day of creatine + 0.1 g/kg/day of maltodextrin), Creatine-Moderate', 'Creatine Supplementation', 'creatine + 0.3 g/kg/day of maltodextrin) or Placebo', 'maltodextrin']","['Aging Muscle Performance', 'time for muscle strength', 'physical performance (dynamic balance', 'muscle strength (1-repetition maximum leg press, chest press, hand-grip), muscle endurance (leg press and chest press; maximal number of repetitions performed for 1 set']",[],"[{'cui': 'C0860942', 'cui_str': 'Creatine increased'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C1532536', 'cui_str': 'g/kg/day'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2607857'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0036849', 'cui_str': 'Set'}]",,0.217584,"There was a significant increase over time for muscle strength (Leg press: CR-H pre 161.5 ± 55.1 kg, post 169.2 ± 59.2 kg; CR-M pre 145.2 ± 47.7 kg, post 151.7 ± 45.0 kg; PLA pre 163.7 ± 51.5 kg, post 178.2 ± 65.6 kg, p = 0.001; Chest press: CR-H pre 57.0 ± 26.2 kg, post 58.8 ± 28.0 kg; CR-M pre 54.5 ± 27.9 kg, post 56.8 ± 30.1 kg; PLA pre 55.1 ± 26.9 kg, post 58.5 ± 30.1 kg, p = 0.001) and endurance (Leg press: CR-H pre 17.1 ± 6.0 reps, post 21.0 ± 7.2 reps; CR-M pre 24.1 ± 11.6 reps, post 29.1 ± 17.0 reps; PLA pre 23.8 ± 9.7 reps, post 29.5 ± 11.9 reps, p = 0.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chami', 'Affiliation': 'Darren G. Candow, PhD, Professor and Associate Dean-Graduate Studies and Research, Faculty of Kinesiology and Health Studies, 3737 Wascana Parkway, University of Regina, Regina SK Canada, S4S 0A2, KHS.GSR-AssocDean@uregina.ca.'}, {'ForeName': 'D G', 'Initials': 'DG', 'LastName': 'Candow', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-018-1148-8']
1221,29659963,Saturated Fats from Butter but Not from Cheese Increase HDL-Mediated Cholesterol Efflux Capacity from J774 Macrophages in Men and Women with Abdominal Obesity.,"Background


Recent evidence suggests that the association between dietary saturated fatty acids (SFAs) and coronary artery disease risk varies according to food sources. How SFAs from butter and cheese influence HDL-mediated cholesterol efflux capacity (CEC), a key process in reverse cholesterol transport, is currently unknown.
Objective


In a predefined secondary analysis of a previously published trial, we have examined how diets rich in SFAs from either cheese or butter influence HDL-mediated CEC, compared with diets rich in either monounsaturated fatty acids (MUFAs) or polyunsaturated fatty acids (PUFAs).
Methods


In a randomized crossover controlled consumption trial, 46 men and women with abdominal obesity consumed 5 isocaloric diets, each for 4 wk. Two diets were rich in SFAs either from cheese (CHEESE) or butter (BUTTER) [12.4-12.6% of energy (%E) as SFAs, 32%E as fat, 52%E as carbohydrates]. In 2 other diets, SFAs (5.8%E) were replaced with either MUFAs from refined olive oil (MUFA) or PUFAs from corn oil (PUFA). Finally, a lower fat and carbohydrate diet was used as a control (5.8%E as SFAs, 25.0%E as fat, 59%E as carbohydrates; CHO). Post-diet HDL-mediated CEC was determined ex vivo using radiolabelled J774 macrophages incubated with apolipoprotein B-depleted serum from the participants.
Results


Mean (±SD) age was 41.4 ± 14.2 y, and waist circumference was 107.6 ± 11.5 cm in men and 94.3 ± 12.4 cm in women. BUTTER and MUFA increased HDL-mediated CEC compared with CHEESE (+4.3%, P = 0.026 and +4.7%, P = 0.031, respectively). Exploring the significant diet × sex interaction (P = 0.044) revealed that the increase in HDL-mediated CEC after BUTTER compared with CHEESE was significant among men (+6.0%, P = 0.047) but not women (+2.9%, P = 0.19), whereas the increase after MUFA compared with CHEESE was significant among women (+9.1%, P = 0.008) but not men (-0.6%, P = 0.99).
Conclusion


These results provide evidence of a food matrix effect modulating the impact of dairy SFAs on HDL-mediated CEC with potential sex-related differences that deserve further investigation. This trial was registered at clinicaltrials.gov as NCT02106208.",2018,"BUTTER and MUFA increased HDL-mediated CEC compared with CHEESE (+4.3%, P = 0.026 and +4.7%, P = 0.031, respectively).","['Mean (±SD) age was 41.4\xa0±\xa014.2 y, and waist circumference was 107.6\xa0±\xa011.5 cm in men and 94.3\xa0±\xa012.4 cm in women', 'Men and Women with Abdominal Obesity', '46 men and women with abdominal obesity consumed 5 isocaloric diets, each for 4 wk']","['MUFAs from refined olive oil (MUFA) or PUFAs from corn oil (PUFA', 'Saturated Fats from Butter', 'monounsaturated fatty acids (MUFAs) or polyunsaturated fatty acids (PUFAs']",['HDL-mediated CEC'],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C4517534', 'cui_str': '11.5 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517543', 'cui_str': '12.4 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0311277', 'cui_str': 'Central Obesity'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C0006494', 'cui_str': 'Butter'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0318601', 'cui_str': 'Canine enteric calicivirus (organism)'}]",46.0,0.0601803,"BUTTER and MUFA increased HDL-mediated CEC compared with CHEESE (+4.3%, P = 0.026 and +4.7%, P = 0.031, respectively).","[{'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Brassard', 'Affiliation': ""Institute of Nutrition and Functional Foods (INAF), School of Nutrition, Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ) and Department of Medicine, Department of Social and Preventive Medicine, CHU de Quebec Research Center, and Department of Kinesiology, Faculty of Medicine, Laval University, Quebec, Canada.""}, {'ForeName': 'Benoît J', 'Initials': 'BJ', 'LastName': 'Arsenault', 'Affiliation': ""Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ) and Department of Medicine, Department of Social and Preventive Medicine, CHU de Quebec Research Center, and Department of Kinesiology, Faculty of Medicine, Laval University, Quebec, Canada.""}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Boyer', 'Affiliation': ""Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ) and Department of Medicine, Department of Social and Preventive Medicine, CHU de Quebec Research Center, and Department of Kinesiology, Faculty of Medicine, Laval University, Quebec, Canada.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Bernic', 'Affiliation': ""Institute of Nutrition and Functional Foods (INAF), School of Nutrition, Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ) and Department of Medicine, Department of Social and Preventive Medicine, CHU de Quebec Research Center, and Department of Kinesiology, Faculty of Medicine, Laval University, Quebec, Canada.""}, {'ForeName': 'Maude', 'Initials': 'M', 'LastName': 'Tessier-Grenier', 'Affiliation': ""Institute of Nutrition and Functional Foods (INAF), School of Nutrition, Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ) and Department of Medicine, Department of Social and Preventive Medicine, CHU de Quebec Research Center, and Department of Kinesiology, Faculty of Medicine, Laval University, Quebec, Canada.""}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Talbot', 'Affiliation': 'Department of Social and Preventive Medicine, CHU de Quebec Research Center, and Department of Kinesiology, Faculty of Medicine, Laval University, Quebec, Canada.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Tremblay', 'Affiliation': ""Institute of Nutrition and Functional Foods (INAF), School of Nutrition, Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ) and Department of Medicine, Department of Social and Preventive Medicine, CHU de Quebec Research Center, and Department of Kinesiology, Faculty of Medicine, Laval University, Quebec, Canada.""}, {'ForeName': 'Emile', 'Initials': 'E', 'LastName': 'Levy', 'Affiliation': ""Institute of Nutrition and Functional Foods (INAF), School of Nutrition, Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ) and Department of Medicine, Department of Social and Preventive Medicine, CHU de Quebec Research Center, and Department of Kinesiology, Faculty of Medicine, Laval University, Quebec, Canada.""}, {'ForeName': 'Bela', 'Initials': 'B', 'LastName': 'Asztalos', 'Affiliation': 'Cardiovascular Nutrition Laboratory, Human Nutrition Research Center on Aging, Tufts University, Boston, MA.'}, {'ForeName': 'Peter J H', 'Initials': 'PJH', 'LastName': 'Jones', 'Affiliation': 'Richardson Centre for Functional Foods and Nutraceuticals (RCFFN), University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Couture', 'Affiliation': ""Institute of Nutrition and Functional Foods (INAF), School of Nutrition, Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ) and Department of Medicine, Department of Social and Preventive Medicine, CHU de Quebec Research Center, and Department of Kinesiology, Faculty of Medicine, Laval University, Quebec, Canada.""}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Lamarche', 'Affiliation': ""Institute of Nutrition and Functional Foods (INAF), School of Nutrition, Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ) and Department of Medicine, Department of Social and Preventive Medicine, CHU de Quebec Research Center, and Department of Kinesiology, Faculty of Medicine, Laval University, Quebec, Canada.""}]",The Journal of nutrition,['10.1093/jn/nxy014']
1222,16679630,"Results of a single blind, randomized, placebo-controlled clinical trial to study the effect of intravenous L-carnitine supplementation on health-related quality of life in Indian patients on maintenance hemodialysis.","BACKGROUND


Carnitine insufficiency is responsible for various co-morbid conditions in maintenance hemodialysis (MHD) patients. L-carnitine supplementation is expected to improve the quality of life (QoL) of patients on MHD.
AIMS


To study the effect of L-carnitine supplementation on QoL of Indian patients on MHD.
SETTING AND DESIGN


This was a single (patient) blind, randomized, placebo-controlled clinical trial conducted on patients on MHD attending hemodialysis unit of the study center.
MATERIALS AND METHODS


Twenty patients on MHD suffering from hemodialysis-related symptoms were randomly assigned to receive intravenous L-carnitine 20 mg/kg or placebo after every dialysis session for 8 weeks. SF36 (Short Form with 36 questions) score for QoL, laboratory investigations and dialysis related symptoms were recorded at baseline and after 8 weeks. Improvement in QoL, laboratory parameters and dialysis related symptoms in the two groups after 8 weeks was compared.
STATISTICAL ANALYSIS USED


Depending on normality of data, unpaired T test or Mann Whitney U test was used for comparison of change (8 weeks-baseline) in SF36 scores and laboratory parameters observed in the two groups.
RESULTS


L-carnitine supplementation increased total SF36 score by 18.29 +/- 12.71 (95% CI: 10.41 to 26) while placebo resulted in reduction in total SF36 score by 6.4 +/- 16.39 (95% CI: -16.59 to 3.73). L-carnitine also resulted in significant increase in hemoglobin and serum albumin and decrease in serum creatinine as compared to placebo. More patients were relieved of dialysis related symptoms in L-carnitine group.
CONCLUSION


Intravenous L-carnitine supplementation improves QoL in patients on MHD.",2006,L-carnitine also resulted in significant increase in hemoglobin and serum albumin and decrease in serum creatinine as compared to placebo.,"['patients on MHD', 'Indian patients on maintenance hemodialysis', 'patients on MHD attending hemodialysis unit of the study center', 'maintenance hemodialysis (MHD) patients', 'Indian patients on MHD', 'Twenty patients on MHD suffering from hemodialysis-related symptoms']","['intravenous L-carnitine 20 mg/kg or placebo', 'L-carnitine supplementation', 'placebo', 'Intravenous L-carnitine supplementation', 'intravenous L-carnitine supplementation']","['health-related quality of life', 'SF36 scores and laboratory parameters', 'serum creatinine', 'hemoglobin and serum albumin', 'quality of life (QoL', 'total SF36 score', 'QoL, laboratory parameters and dialysis related symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0087163', 'cui_str': 'l-carnitine'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.266676,L-carnitine also resulted in significant increase in hemoglobin and serum albumin and decrease in serum creatinine as compared to placebo.,"[{'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Rathod', 'Affiliation': 'Department of Pharmacology, Department of Medicine, Govt. Medical College, Aurangabad, India.'}, {'ForeName': 'Mirza Siraz', 'Initials': 'MS', 'LastName': 'Baig', 'Affiliation': ''}, {'ForeName': 'P N', 'Initials': 'PN', 'LastName': 'Khandelwal', 'Affiliation': ''}, {'ForeName': 'S G', 'Initials': 'SG', 'LastName': 'Kulkarni', 'Affiliation': ''}, {'ForeName': 'P R', 'Initials': 'PR', 'LastName': 'Gade', 'Affiliation': ''}, {'ForeName': 'Samra', 'Initials': 'S', 'LastName': 'Siddiqui', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1223,20075555,The placebo therapy.,,2009,,[],['placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.230129,,"[{'ForeName': 'Sourabh', 'Initials': 'S', 'LastName': 'Aggarwal', 'Affiliation': ''}]",Indian journal of medical sciences,['10.4103/0019-5359.58883']
1224,30851861,The iCook 4-H Study: An Intervention and Dissemination Test of a Youth/Adult Out-of-School Program.,"OBJECTIVE


To describe outcomes from intervention and dissemination of iCook 4-H.
DESIGN


Five-state, community-based participatory research and a randomized, controlled trial followed by a 5-state, nonrandomized dissemination test of the iCook 4-H curriculum with control and treatment groups.
SETTING


Community and university sites.
PARTICIPANTS


Youths aged 9-10 years and their adult food preparer; 228 dyads in the intervention and 74 dyads in dissemination.
INTERVENTION(S)


Theoretical frameworks were Social Cognitive Theory and the experiential 4-H learning model. Six 2-hour, biweekly sessions on cooking, eating, and playing together followed by monthly newsletters and boosters until 24 months, expanded to 8 sessions for dissemination.
MAIN OUTCOME MEASURE(S)


Youth body mass index (BMI) z-scores, measured height and weight, and youth/adult program outcome evaluations surveys.
ANALYSIS


Linear mixed models, group, time, and group × time interaction for BMI z-score and program outcomes changes. Significance levels = P ≤ .05; interaction term significance = P ≤ .10.
RESULTS


In intervention, treatment BMI z-scores increased compared with controls based on significant interaction (P = .04). For odds of being overweight or obese at 24 months, there was no significant interaction (P = .18). In dissemination, based on significant interaction, treatment youths increased cooking skills (P = .03) and treatment adults increased cooking together (P = .08) and eating together (P = .08) compared with controls.
CONCLUSIONS AND IMPLICATIONS


iCook 4-H program outcomes were positive for mealtime activities of cooking and eating together. The program can be successfully implemented by community educators. The increase in BMI z-scores needs further evaluation for youths in cooking programs.",2019,"In dissemination, based on significant interaction, treatment youths increased cooking skills (P = .03) and treatment adults increased cooking together (P = .08) and eating together (P = .08) compared with controls.
","['Youth/Adult Out-of-School Program', 'Community and university sites', 'Youths aged 9-10 years and their adult food preparer; 228 dyads in the intervention and 74 dyads in dissemination']",[],"['BMI) z-scores, measured height and weight, and youth/adult program outcome evaluations surveys', 'Youth body mass index', 'mealtime activities of cooking and eating together', 'cooking skills', 'BMI z-scores', 'treatment BMI z-scores']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",[],"[{'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0424638', 'cui_str': 'Height and weight'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0587119', 'cui_str': 'Meal Times'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1306756', 'cui_str': 'Cook (occupation)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.0283478,"In dissemination, based on significant interaction, treatment youths increased cooking skills (P = .03) and treatment adults increased cooking together (P = .08) and eating together (P = .08) compared with controls.
","[{'ForeName': 'Adrienne A', 'Initials': 'AA', 'LastName': 'White', 'Affiliation': 'School of Food and Agriculture, University of Maine, Orono, ME. Electronic address: awhite@maine.edu.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Colby', 'Affiliation': 'Department of Nutrition, University of Tennessee, Knoxville, TN.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Franzen-Castle', 'Affiliation': 'Nutrition and Health Sciences Department, University of Nebraska-Lincoln, Lincoln, NE.'}, {'ForeName': 'Kendra K', 'Initials': 'KK', 'LastName': 'Kattelmann', 'Affiliation': 'Department of Health and Nutritional Sciences, South Dakota State University, Brookings, SD.'}, {'ForeName': 'Melissa D', 'Initials': 'MD', 'LastName': 'Olfert', 'Affiliation': 'Davis College of Agriculture, Natural Resources, and Design, Division of Animal and Nutritional Sciences, West Virginia University, Morgantown, WV.'}, {'ForeName': 'Tara A', 'Initials': 'TA', 'LastName': 'Gould', 'Affiliation': 'School of Food and Agriculture, University of Maine, Orono, ME.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Hagedorn', 'Affiliation': 'Davis College of Agriculture, Natural Resources, and Design, Division of Animal and Nutritional Sciences, West Virginia University, Morgantown, WV.'}, {'ForeName': 'Douglas R', 'Initials': 'DR', 'LastName': 'Mathews', 'Affiliation': 'School of Food and Agriculture, University of Maine, Orono, ME.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Moyer', 'Affiliation': 'School of Public Health and Health Sciences, Department of Biostatistics and Epidemiology, University of Massachusetts, Amherst, MA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'Department of Health and Nutritional Sciences, South Dakota State University, Extension, Brookings, SD.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Yerxa', 'Affiliation': 'University of Maine Cooperative Extension, Orono, ME.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2018.11.012']
1225,30861694,Different exercise modalities exert opposite acute effects on short-term blood pressure variability in male patients with hypertension.,"BACKGROUND


The aim of this study was to compare the acute effects produced by a single bout of three different exercise modalities on short-term blood pressure variability.
METHODS


The study enrolled 21 sedentary male patients with hypertension and a mean age of 63 ± 7.2 years. Blood pressure variability was evaluated through ambulatory blood pressure monitoring that was performed twice: during an ordinary daily activity and after an exercise session lasting 60 minutes. Patients were divided into three groups according to the different exercise modality performed during the session: aerobic continuous training, interval training or combined training including aerobic and resistance training.
RESULTS


Twenty-four-hour systolic blood pressure variability increased in the interval training group, was unchanged in the aerobic continuous training group and decreased in the combined training group (intergroup  P  = 0.03). Daytime systolic blood pressure variability increased in the interval training and aerobic continuous training groups while it decreased in the combined training group (intergroup  P  = 0.0006). Twenty-four-hour diastolic blood pressure variability decreased in the aerobic continuous training and combined training groups while it increased in the interval training group (intergroup  P  = 0.002).
CONCLUSION


Different training modalities have similar hypotensive action but exert different acute effects on blood pressure variability. Combined training seems to be the most suitable training modality for sedentary men with hypertension.",2019,Daytime systolic blood pressure variability increased in the interval training and aerobic continuous training groups while it decreased in the combined training group (intergroup  P  = 0.0006).,"['male patients with hypertension', '21 sedentary male patients with hypertension and a mean age of 63\u2009±\u20097.2 years', 'sedentary men with hypertension']","['aerobic continuous training, interval training or combined training including aerobic and resistance training']","['Daytime systolic blood pressure variability', 'systolic blood pressure variability', 'Blood pressure variability', 'blood pressure variability', 'diastolic blood pressure variability']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}]",21.0,0.0147415,Daytime systolic blood pressure variability increased in the interval training and aerobic continuous training groups while it decreased in the combined training group (intergroup  P  = 0.0006).,"[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Caminiti', 'Affiliation': '1 Department of Medical Sciences, IRCCS San Raffaele, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Mancuso', 'Affiliation': '1 Department of Medical Sciences, IRCCS San Raffaele, Italy.'}, {'ForeName': 'Ana Filipa', 'Initials': 'AF', 'LastName': 'Raposo', 'Affiliation': '2 Department of Internal Medicine, Hospital de Cascais, Dr Jose de Almeida, Cascais, Portugal.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Fossati', 'Affiliation': '3 Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Selli', 'Affiliation': '1 Department of Medical Sciences, IRCCS San Raffaele, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Volterrani', 'Affiliation': '1 Department of Medical Sciences, IRCCS San Raffaele, Italy.'}]",European journal of preventive cardiology,['10.1177/2047487318819529']
1226,30833160,Immunogenicity and safety of measles-rubella vaccine co-administered with attenuated Japanese encephalitis SA 14-14-2 vaccine in infants aged 8 months in China: a non-inferiority randomised controlled trial.,"BACKGROUND


In China, measles-rubella vaccine and live attenuated SA 14-14-2 Japanese encephalitis vaccine (LJEV) are recommended for simultaneous administration at 8 months of age, which is the youngest recommended age for these vaccines worldwide. We aimed to assess the effect of the co-administration of these vaccines at 8 months of age on the immunogenicity of measles-rubella vaccine.
METHODS


We did a multicentre, open-label, non-inferiority, two-group randomised controlled trial in eight counties or districts in China. We recruited healthy infants aged 8 months who had received all scheduled vaccinations according to the national immunisation recommendations and who lived in the county of the study site. Enrolled infants were randomly assigned (1:1) to receive either measles-rubella vaccine and LJEV simultaneously (measles-rubella plus LJEV group) or measles-rubella vaccine alone (measles-rubella group). The primary outcome was the proportion of infants with IgG antibody seroconversion for measles 6 weeks after vaccination, and a secondary outcome was the proportion of infants with IgG antibody seroconversion for rubella 6 weeks after vaccination. Analyses included all infants who completed the study. We used a 5% margin to establish non-inferiority. This trial was registered at ClinicalTrials.gov (NCT02643433).
FINDINGS


1173 infants were assessed for eligibility between Aug 13, 2015, and June 10, 2016. Of 1093 (93%) enrolled infants, 545 were randomly assigned to the measles-rubella plus LJEV group and 548 to the measles-rubella group. Of the infants assigned to each group, 507 in the measles-rubella plus LJEV group and 506 in the measles-rubella group completed the study. Before vaccination, six (1%) of 507 infants in the measles-rubella plus LJEV group and one (<1%) of 506 in the measles-rubella group were seropositive for measles; eight (2%) infants in the measles-rubella plus LJEV group and two (<1%) in the measles-rubella group were seropositive for rubella. 6 weeks after vaccination, measles seroconversion in the measles-rubella plus LJEV group (496 [98%] of 507) was non-inferior to that in the measles-rubella group (499 [99%] of 506; difference -0·8% [90% CI -2·6 to 1·1]) and rubella seroconversion in the measles-rubella plus LJEV group (478 [94%] of 507) was non-inferior to that in the measles-rubella group (473 [94%] of 506 infants; difference 0·8% [90% CI -1·8 to 3·4]). There were no serious adverse events in either group and no evidence of a difference between the two groups in the prevalence of any local adverse event (redness, rashes, and pain) or systemic adverse event (fever, allergy, respiratory infections, diarrhoea, and vomiting). Fever was the most common adverse event (97 [19%] of 507 infants in the measles-rubella plus LJEV group; 108 [21%] of 506 infants in the measles-rubella group).
INTERPRETATION


The evidence of similar seroconversion and safety with co-administered LJEV and measles-rubella vaccines supports the co-administration of these vaccines to infants aged 8 months. These results will be important for measles and rubella elimination and the expansion of Japanese encephalitis vaccination in countries where it is endemic.
FUNDING


US Centers for Disease Control and Prevention, US Department of Health and Human Services; China-US Collaborative Program on Emerging and Re-emerging Infectious Diseases.",2019,"There were no serious adverse events in either group and no evidence of a difference between the two groups in the prevalence of any local adverse event (redness, rashes, and pain) or systemic adverse event (fever, allergy, respiratory infections, diarrhoea, and vomiting).","['Of 1093 (93%) enrolled infants, 545', '1173 infants were assessed for eligibility between Aug 13, 2015, and June 10, 2016', 'healthy infants aged 8 months who had received all scheduled vaccinations according to the national immunisation recommendations and who lived in the county of the study site', 'eight counties or districts in China', 'group and 506 in the measles-rubella group completed the study', 'group and 548 to the measles-rubella group', 'infants aged 8 months in China']","['measles-rubella vaccine and LJEV simultaneously (measles-rubella plus LJEV group) or measles-rubella vaccine alone (measles-rubella group', 'LJEV', 'measles-rubella plus LJEV', 'measles-rubella vaccine co-administered with attenuated Japanese encephalitis SA 14-14-2 vaccine']","['measles seroconversion', 'proportion of infants with IgG antibody seroconversion', 'prevalence of any local adverse event (redness, rashes, and pain) or systemic adverse event (fever, allergy, respiratory infections, diarrhoea, and vomiting', 'rubella seroconversion', 'serious adverse events', 'Fever', 'Immunogenicity and safety']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4517809', 'cui_str': 'Five hundred and forty-five'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0025007', 'cui_str': 'Rubeola'}, {'cui': 'C0035920', 'cui_str': 'Measles, German'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0035923', 'cui_str': 'rubella, live attenuated'}, {'cui': 'C0025007', 'cui_str': 'Rubeola'}, {'cui': 'C0035920', 'cui_str': 'Measles, German'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0014057', 'cui_str': 'Viral Encephalitis, Japanese B'}, {'cui': 'C4277085', 'cui_str': 'SA-14-14-2 vaccine'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0035920', 'cui_str': 'Measles, German'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1173.0,0.180644,"There were no serious adverse events in either group and no evidence of a difference between the two groups in the prevalence of any local adverse event (redness, rashes, and pain) or systemic adverse event (fever, allergy, respiratory infections, diarrhoea, and vomiting).","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'National Immunization Programme, Chinese Center for Disease Control and Prevention, Beijing, China; Immunization Program Department, Lishui Prefectural Center for Disease Control and Prevention, Lishui, China.'}, {'ForeName': 'Susan Y', 'Initials': 'SY', 'LastName': 'Chu', 'Affiliation': 'Global Immunization Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Chenyan', 'Initials': 'C', 'LastName': 'Yue', 'Affiliation': 'National Immunization Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Wannemuehler', 'Affiliation': 'Global Immunization Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Shuyun', 'Initials': 'S', 'LastName': 'Xie', 'Affiliation': 'Immunization Program Department, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, China.'}, {'ForeName': 'Fubin', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Immunization Program Department, Hebei Provincial Center for Disease Control and Prevention, Shijiazhuang, China.'}, {'ForeName': 'Yamin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'National Immunization Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Yuxi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Immunization Program Department, Baoding Prefectural Center for Disease Control and Prevention, Baoding, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': 'Immunization Program Department, Ningbo Prefectural Center for Disease Control and Prevention, Ningbo, China.'}, {'ForeName': 'Yumin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'National Immunization Programme, Chinese Center for Disease Control and Prevention, Beijing, China; Immunization Program Department, Lishui Prefectural Center for Disease Control and Prevention, Lishui, China.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Zuo', 'Affiliation': 'Immunization Program Department, Baoding Prefectural Center for Disease Control and Prevention, Baoding, China.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Rodewald', 'Affiliation': 'Global Immunization Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Qiyou', 'Initials': 'Q', 'LastName': 'Xiao', 'Affiliation': 'National Immunization Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Zijian', 'Initials': 'Z', 'LastName': 'Feng', 'Affiliation': 'National Immunization Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Huaqing', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'National Immunization Programme, Chinese Center for Disease Control and Prevention, Beijing, China. Electronic address: wanghq@chinacdc.cn.'}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'An', 'Affiliation': 'National Immunization Programme, Chinese Center for Disease Control and Prevention, Beijing, China. Electronic address: anzj@chinacdc.cn.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30650-9']
1227,30739837,Ten-year outcomes of survival and toxicity for a phase III randomised trial of concurrent chemoradiotherapy versus radiotherapy alone in stage II nasopharyngeal carcinoma.,"PURPOSE


Our previous results showed survival benefits of concurrent chemoradiotherapy (CCRT) in treating stage II nasopharyngeal carcinoma (NPC) compared with radiotherapy (RT) alone. Here, we present the updated 10-year survival results and late toxicity profile to assess the ultimate effectiveness of concurrent chemotherapy.
METHODS


Patients with stage II NPC were randomly assigned to RT arm (n = 114) or to CCRT arm (n = 116) with a concurrent weekly cisplatin regimen. The primary end-point was overall survival (OS).
RESULTS


With a median follow-up of 125 months, significant improvements in OS (83.6% vs 65.8%, P = 0.001), progression-free survival (76.7% vs 64.0%, P = 0.014), cancer-specific survival (86.2% vs 71.9%, P = 0.002), distant-metastasis free survival (94.0% vs 83.3%, P = 0.007) were observed in CCRT arm. In point of locoregional-relapse free survival, the impact of CCRT was not remarkable. The findings were in accordance with our previous report. The survival benefits earned by CCRT mainly reflected in T2N1 population. Although CCRT brought more acute toxic effects (P = 0.001), as presented in previous report, the late toxicities and treatment-associated deaths events were comparable between two arms.
CONCLUSIONS


Ten-year outcomes confirmed that CCRT could improve the OS of stage II patients without adding late toxicities compared with conventional RT.",2019,"Although CCRT brought more acute toxic effects (P = 0.001), as presented in previous report, the late toxicities and treatment-associated deaths events were comparable between two arms.
","['Patients with stage II NPC', 'stage II nasopharyngeal carcinoma']","['cisplatin regimen', 'conventional RT', 'radiotherapy (RT) alone', 'concurrent chemoradiotherapy (CCRT', 'radiotherapy alone', 'CCRT', 'concurrent chemoradiotherapy']","['OS', 'progression-free survival', 'distant-metastasis free survival', 'overall survival (OS', 'acute toxic effects', 'survival and toxicity', 'late toxicities and treatment-associated deaths events', 'survival benefits', 'cancer-specific survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma (disorder)'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",,0.299839,"Although CCRT brought more acute toxic effects (P = 0.001), as presented in previous report, the late toxicities and treatment-associated deaths events were comparable between two arms.
","[{'ForeName': 'Xiao-Yun', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: lixy1@sysucc.org.cn.'}, {'ForeName': 'Qiu-Yan', 'Initials': 'QY', 'LastName': 'Chen', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: chenqy@sysucc.org.cn.'}, {'ForeName': 'Xue-Song', 'Initials': 'XS', 'LastName': 'Sun', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: sunxs@sysucc.org.cn.'}, {'ForeName': 'Sai-Lan', 'Initials': 'SL', 'LastName': 'Liu', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: liusl@sysucc.org.cn.'}, {'ForeName': 'Jin-Jie', 'Initials': 'JJ', 'LastName': 'Yan', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: yanjj@sysucc.org.cn.'}, {'ForeName': 'Shan-Shan', 'Initials': 'SS', 'LastName': 'Guo', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: guoshsh@sysucc.org.cn.'}, {'ForeName': 'Li-Ting', 'Initials': 'LT', 'LastName': 'Liu', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: liult@sysucc.org.cn.'}, {'ForeName': 'Hao-Jun', 'Initials': 'HJ', 'LastName': 'Xie', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: xiehj@sysucc.org.cn.'}, {'ForeName': 'Qing-Nan', 'Initials': 'QN', 'LastName': 'Tang', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: tangqn@sysucc.org.cn.'}, {'ForeName': 'Yu-Jing', 'Initials': 'YJ', 'LastName': 'Liang', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: liangyuj@sysucc.org.cn.'}, {'ForeName': 'Yue-Feng', 'Initials': 'YF', 'LastName': 'Wen', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: wenyf@sysucc.org.cn.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: guoling@sysucc.org.cn.'}, {'ForeName': 'Hao-Yuan', 'Initials': 'HY', 'LastName': 'Mo', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: mohy@sysucc.org.cn.'}, {'ForeName': 'Ming-Yuan', 'Initials': 'MY', 'LastName': 'Chen', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: chenmy@sysucc.org.cn.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: sunying@sysucc.org.cn.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: majun@sysucc.org.cn.'}, {'ForeName': 'Lin-Quan', 'Initials': 'LQ', 'LastName': 'Tang', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: tanglq@sysucc.org.cn.'}, {'ForeName': 'Hai-Qiang', 'Initials': 'HQ', 'LastName': 'Mai', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, PR China. Electronic address: maihq@sysucc.org.cn.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2018.10.020']
1228,30822378,Economic evaluation of a tailored therapist-guided internet-based cognitive behavioural treatment for patients with psoriasis: a randomized controlled trial.,,2019,,['patients with psoriasis'],['tailored therapist-guided internet-based cognitive behavioural treatment'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.151877,,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'van Beugen', 'Affiliation': 'Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ferwerda', 'Affiliation': 'Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'van Middendorp', 'Affiliation': 'Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'J V', 'Initials': 'JV', 'LastName': 'Smit', 'Affiliation': 'Department of Dermatology, Rijnstate Hospital, Velp, the Netherlands.'}, {'ForeName': 'M E J', 'Initials': 'MEJ', 'LastName': 'Zeeuwen-Franssen', 'Affiliation': 'Department of Dermatology, Canisius-Wilhelmina Hospital, Nijmegen, the Netherlands.'}, {'ForeName': 'E B M', 'Initials': 'EBM', 'LastName': 'Kroft', 'Affiliation': 'Department of Dermatology, Ziekenhuisgroep Twente, Almelo, the Netherlands.'}, {'ForeName': 'E M G J', 'Initials': 'EMGJ', 'LastName': 'de Jong', 'Affiliation': 'Department of Dermatology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'P C M', 'Initials': 'PCM', 'LastName': 'van de Kerkhof', 'Affiliation': 'Department of Dermatology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Kievit', 'Affiliation': 'Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'A W M', 'Initials': 'AWM', 'LastName': 'Evers', 'Affiliation': 'Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}]",The British journal of dermatology,['10.1111/bjd.17848']
1229,31704161,Cardiovascular risk and the implications for clinical practice of cardiovascular outcome trials in type 2 diabetes.,"Cardiovascular disease (CVD) is the primary cause of morbidity and mortality in patients with type 2 diabetes (T2D). This review examines the impact of cardiovascular outcome trials (CVOTs) on clinical practice. To date, all CVOTs have shown non-inferiority versus placebo (both added to standard of care) against a primary endpoint of 3- or 4-point major adverse cardiovascular event (MACE), confirming CV safety of these treatments. Additionally, some CVOTs have shown superiority to placebo against the same MACE endpoint, suggesting a cardioprotective action for these treatments. This is reflected in guideline updates, which primary care physicians should consider when personalizing treatments.",2019,"To date, all CVOTs have shown non-inferiority versus placebo (both added to standard of care) against a primary endpoint of 3- or 4-point major adverse cardiovascular event (MACE), confirming CV safety of these treatments.","['patients with type 2 diabetes (T2D', 'type 2 diabetes']",['placebo'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.166855,"To date, all CVOTs have shown non-inferiority versus placebo (both added to standard of care) against a primary endpoint of 3- or 4-point major adverse cardiovascular event (MACE), confirming CV safety of these treatments.","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Chilton', 'Affiliation': 'Division of Cardiology, University of Texas Health Science Center, San Antonio, TX, USA. Electronic address: chilton@uthscsa.edu.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Dungan', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Jay H', 'Initials': 'JH', 'LastName': 'Shubrook', 'Affiliation': 'Touro University California College of Osteopathic Medicine, Primary Care Department, Vallejo, CA, USA.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Center of Diabetes and Metabolism, Emory University, Atlanta, GA, USA.'}]",Primary care diabetes,['10.1016/j.pcd.2019.09.008']
1230,16062017,Evaluation of the efficacy of mifepristone/misoprostol and methotrexate/misoprostol for medical abortion.,"BACKGROUND


Unsafe abortion is a major cause of mortality among women in India accounting for 12% of all maternal deaths. In developing countries, annually, up to 200,000 women die of complications after illegal abortion. Medical abortion is potentially a simple and a safe method for use in developing countries. We conducted a prospective controlled trial to compare the efficacy of low-lose mifepristone and methotrexate for medical abortion.
OBJECTIVE


To find out the efficacy of low-dose mifepristone and methotrexate for inducing abortion.
METHOD


In this prospective clinical study, 100 women opted for a medical method of abortion. Out of these, 50 patients were given 50 mg/m2 of methotrexate intramuscularly followed by 800 micro gm of intravaginal misoprostol, and 50 patients were given 200 mg of mifepristone orally followed by 800 micro gm of intravaginal misoprostol.
MAIN OUTCOME MEASURES


Complete abortion was the principal outcome measure. Secondary outcome measures were side effects and acceptability data.
RESULTS


The rate of expulsion by first week after initiation of treatment was 58% in methotrexate and 98% in mifepristone group (P <0.001).
CONCLUSION


Low-dose mifepristone and intravaginal misoprostol is safe, effective, and well tolerated as compared to methotrexate and misoprostol.",2005,"The rate of expulsion by first week after initiation of treatment was 58% in methotrexate and 98% in mifepristone group (P <0.001).
","['medical abortion', 'women in India accounting for 12% of all maternal deaths', '100 women opted for a medical method of abortion']","['low-lose mifepristone and methotrexate', 'mifepristone and intravaginal misoprostol', 'methotrexate', 'methotrexate and misoprostol', 'mifepristone/misoprostol and methotrexate/misoprostol', 'mifepristone orally followed by 800 micro gm of intravaginal misoprostol', 'methotrexate intramuscularly followed by 800 micro gm of intravaginal misoprostol', 'mifepristone and methotrexate', 'mifepristone']","['side effects and acceptability data', 'rate of expulsion']","[{'cui': 'C3146283', 'cui_str': 'Medical abortion'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C3494405', 'cui_str': 'Maternal Death'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal (qualifier value)'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1293107', 'cui_str': 'Expulsion (procedure)'}]",200000.0,0.110423,"The rate of expulsion by first week after initiation of treatment was 58% in methotrexate and 98% in mifepristone group (P <0.001).
","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dahiya', 'Affiliation': 'Department of Obstetrics and Gynaecology, Pt. B.D. Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana, India. krishnadahiya@rediffmail.com'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Madan', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hooda', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sangwan', 'Affiliation': ''}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Khosla', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1231,29078018,Cervical mucus removal prior to intrauterine insemination: a randomized trial.,"OBJECTIVE


To detect if removing the cervical mucus before performing intrauterine insemination (IUI) could improve pregnancy outcomes in patients with unexplained infertility.
DESIGN


Prospective randomized study.
SETTING


An Egyptian University Hospital.
POPULATION


Seven hundred and fourteen couples with unexplained infertility who underwent intrauterine insemination (IUI) with or without cervical mucus removal.
METHODS


Using computer-generated numbers, patients were randomly allocated to cervical-mucus-removal (removed from both internal and external os) or non-mucus-removal groups. Only participants were blinded as to group assignment.
MAIN OUTCOME MEASURES


The clinical pregnancy rate.
RESULTS


Of 714 IUI patients between November 2014 and March 2017, 361 were in the mucus removal group, and 353 in the non-mucus-removal group. Difficult catheterization was encountered in 17 cases out of 666 (2.6%) 12 in the cervical-mucus-removal group and five in the non-mucus-removal group). A total of 666 IUI cycles were completed while 48 were either cancelled or lost in their follow-up. The clinical pregnancy rate was significantly higher in the mucus-removal group [31.0% (n = 112)] than in the non-mucus-removal group [21.8% (n = 77); P = 0.005]. Ovarian hyperstimulation developed in 33 (4.6%) cases: 18 cervical mucus-removal and 15 non-mucus-removal. All except one were mild and managed with outpatient care.
CONCLUSIONS


Cervical mucus removal before IUI could improve pregnancy outcomes in women with unexplained infertility.
TWEETABLE ABSTRACT


Cervical mucus removal before IUI can improve pregnancy outcomes.",2018,The clinical pregnancy rate was significantly higher in the mucus-removal group [31.0% (n = 112)] than in the non-mucus-removal group [21.8% (n = 77); P = 0.005].,"['women with unexplained infertility', 'patients with unexplained infertility', '714 IUI patients between November 2014 and March 2017', ' 361 were in the mucus removal group, and 353 in the non-mucus-removal group', 'An Egyptian University Hospital', 'A total of 666 IUI cycles were completed while 48 were either cancelled or lost in their follow-up', 'Seven hundred and fourteen couples with unexplained infertility who underwent intrauterine insemination (IUI) with or without cervical mucus removal']","['intrauterine insemination (IUI', 'Cervical mucus removal prior to intrauterine insemination', 'cervical-mucus-removal (removed from both internal and external os) or non-mucus-removal groups']","['Ovarian hyperstimulation', 'clinical pregnancy rate', 'pregnancy outcomes']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026727', 'cui_str': 'Mucus'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0337801', 'cui_str': 'Egyptians (ethnic group)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205544', 'cui_str': 'Canceled (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination (procedure)'}, {'cui': 'C0007872', 'cui_str': 'Cervical Mucus'}]","[{'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination (procedure)'}, {'cui': 'C0007872', 'cui_str': 'Cervical Mucus'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1292747', 'cui_str': 'Removes from'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C1185785', 'cui_str': 'External os structure'}, {'cui': 'C0026727', 'cui_str': 'Mucus'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0549383', 'cui_str': 'Hyperstimulation of ovaries (disorder)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",714.0,0.110632,The clinical pregnancy rate was significantly higher in the mucus-removal group [31.0% (n = 112)] than in the non-mucus-removal group [21.8% (n = 77); P = 0.005].,"[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Maher', 'Affiliation': 'Obstetrics and Gynaecology, Faculty of Medicine, Menoufia University, Shebin El-Kom, Egypt.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Sayyed', 'Affiliation': 'Obstetrics and Gynaecology, Faculty of Medicine, Menoufia University, Shebin El-Kom, Egypt.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Elkhouly', 'Affiliation': 'Obstetrics and Gynaecology, Faculty of Medicine, Menoufia University, Shebin El-Kom, Egypt.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.15003']
1232,30821897,A synbiotic supplement for inflammation and oxidative stress and lipid abnormalities in hemodialysis patients.,"INTRODUCTION


Among the most important risk factors for cardiovascular disease in hemodialysis patients are high concentrations of serum inflammation markers, lipid profiles, and oxidative stress. The present study aimed to investigate the effects of a synbiotic supplement on serum systemic inflammation, oxidative stress markers, and lipid profile in hemodialysis patients.
METHODS


Fifty hemodialysis patients were randomly allocated to synbiotic and placebo groups. The synbiotic group received 2 tablets per day of a synbiotic supplement (100 mg) Lactobacillus coagulans and fructo-oligosaccharides for 8 weeks; whereas the placebo group received a similar appearing placebo. At the beginning and end of the study, 5 mL blood was taken after 12-14 hours of fasting.
FINDINGS


Mean values of serum C-reactive protein (hs-CRP) and malondialdehyde (MDA) significantly decreased in the synbiotic group at the end compared to the beginning of the study (P = 0.01). This reduction was significant in comparison with changes in the placebo group (P = 0.01). The synbiotic supplement also reduced serum total cholesterol (P = 0.001) and low-density lipoprotein cholesterol (LDL-c; P = 0.001) compared to the placebo group.
DISCUSSION


The synbiotic supplement used improves serum hs-CRP and MDA, total cholesterol and LDL-c in hemodialysis patients, which are known risk factors for cardiovascular disease.",2019,"The synbiotic supplement also reduced serum total cholesterol (P = 0.001) and low-density lipoprotein cholesterol (LDL-c; P = 0.001) compared to the placebo group.
","['hemodialysis patients', 'Fifty hemodialysis patients']","['synbiotic and placebo', 'placebo', 'synbiotic supplement']","['serum systemic inflammation, oxidative stress markers, and lipid profile', 'Mean values of serum C-reactive protein (hs-CRP) and malondialdehyde (MDA', 'inflammation and oxidative stress and lipid abnormalities', 'Lactobacillus coagulans and fructo-oligosaccharides', 'low-density lipoprotein cholesterol', 'serum inflammation markers, lipid profiles, and oxidative stress', 'serum total cholesterol', 'serum hs-CRP and MDA, total cholesterol and LDL-c']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharides'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]",50.0,0.104253,"The synbiotic supplement also reduced serum total cholesterol (P = 0.001) and low-density lipoprotein cholesterol (LDL-c; P = 0.001) compared to the placebo group.
","[{'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Kooshki', 'Affiliation': 'Traditional and Complementary Medicine Center, Department of Nutrition & Biochemistry, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Tofighiyan', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Miri', 'Affiliation': 'Cellular and Molecular Research Center, Department of Environmental Health Engineering, School of Public Health, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12748']
1233,30834652,"The effect of blood flow rate on dialysis recovery time in patients undergoing maintenance hemodialysis: A prospective, parallel-group, randomized controlled trial.","INTRODUCTION


A majority of patients with end-stage renal disease (ESRD) on in-center hemodialysis (HD) require several hours to recover from an HD session. Patients and caregivers identify fatigue as a high priority for improvement. However, evidence for practical interventions to improve recovery time from conventional in-center HD is lacking. The effect of blood flow rate reduction on dialysis recovery time (DRT) is unknown.
METHODS


Multicenter, single-blinded, randomized, parallel-design controlled trial of blood flow rate reduction vs. usual care. One-hundred two patients with ESRD undergoing maintenance HD in 18 centers with baseline DRT of greater than 6 hours were included as subjects. The intervention was a blood flow rate reduction of 100 mL/min, to a minimum of 300 mL/min. The primary outcome was the between-group difference in change in DRT. Secondary outcomes were changes in London Evaluation of Illness (LEVIL) survey responses from baseline.
FINDINGS


Baseline median DRT was 720 (IQR 360-1013) minutes in controls and 720 (IQR 360-1106) minutes in the intervention group. DRT decreased in both groups. Mean change from baseline (95% confidence interval) at Week 4 in the study was -324 (-473, -175) minutes in the control group and -120 (-329, 90) minutes in the intervention group. The change from baseline was more profound in the control group (P = 0.05). Secondary outcomes of measures of quality of life reported on the LEVIL survey showed more improvement in patients' feelings of general well-being in the control group (P = 0.01). Differences between groups in pain, feeling washed out or drained, sleep quality, shortness of breath, and appetite were not statistically significant.
DISCUSSION


Blood flow rate reduction did not improve DRT over usual care. Though more work needs to be done to address patient-reported fatigue, a significant positive impact may not be achieved without substantial changes in dialysis prescription.",2019,"Differences between groups in pain, feeling washed out or drained, sleep quality, shortness of breath, and appetite were not statistically significant.
","['One-hundred two patients with ESRD undergoing maintenance HD in 18 centers with baseline DRT of greater than 6 hours were included as subjects', 'patients with end-stage renal disease (ESRD) on in-center hemodialysis (HD) require several hours to recover from an HD session', 'patients undergoing maintenance hemodialysis']","['blood flow rate reduction vs. usual care', 'blood flow rate', 'blood flow rate reduction']","['changes in London Evaluation of Illness (LEVIL) survey responses from baseline', 'change in DRT', 'quality of life', 'blood flow rate reduction', 'DRT', ""patients' feelings of general well-being"", 'pain, feeling washed out or drained, sleep quality, shortness of breath, and appetite', 'dialysis recovery time (DRT']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0521108', 'cui_str': 'Recovering from (contextual qualifier) (qualifier value)'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034380'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C2939150', 'cui_str': 'General wellbeing (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",102.0,0.0922163,"Differences between groups in pain, feeling washed out or drained, sleep quality, shortness of breath, and appetite were not statistically significant.
","[{'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Duggal', 'Affiliation': 'Department of Medicine, Division of Nephrology, Stanford University School of Medicine, Palo Alto, California, USA.'}, {'ForeName': 'Wael F', 'Initials': 'WF', 'LastName': 'Hussein', 'Affiliation': 'Department of Medicine, Division of Nephrology, Stanford University School of Medicine, Palo Alto, California, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Reiterman', 'Affiliation': 'Medical Clinical Affairs, Satellite Healthcare, California, San Jose, USA.'}, {'ForeName': 'Sumi J', 'Initials': 'SJ', 'LastName': 'Sun', 'Affiliation': 'Medical Clinical Affairs, Satellite Healthcare, California, San Jose, USA.'}, {'ForeName': 'Graham E', 'Initials': 'GE', 'LastName': 'Abra', 'Affiliation': 'Department of Medicine, Division of Nephrology, Stanford University School of Medicine, Palo Alto, California, USA.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Schiller', 'Affiliation': 'Department of Medicine, Division of Nephrology, Stanford University School of Medicine, Palo Alto, California, USA.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12741']
1234,30833068,"Peginterferon alfa-2a plus tenofovir disoproxil fumarate for hepatitis D (HIDIT-II): a randomised, placebo controlled, phase 2 trial.","BACKGROUND


Hepatitis D is the most severe form of chronic viral hepatitis. Treatment guidelines recommend 1 year of peginterferon alfa, which is effective in 25-30% of patients only. Whether prolonged therapy with peginterferon alfa-2a for 96 weeks and combination therapy with tenofovir disoproxil fumarate (TDF) would increase hepatitis D virus (HDV) RNA suppression is unknown. We aimed to explore whether prolonged treatment of HDV with 96 weeks of peginterferon would increase HDV RNA response rates and reduces post-treatment relapses.
METHODS


We did two parallel, investigator-initiated, multicentre, double-blind randomised, controlled trials at 14 study sites in Germany, Greece, Romania, and Turkey. Patients with chronic HDV infection and compensated liver disease who were aged 18 years or older were eligible for inclusion. All patients were HBsAg positive for at least 7 months, anti-HDV positive for at least 3 months, and HDV-RNA positive at the local laboratory at the screening visit. Patients were ineligible if alanine aminotransferase levels were higher than ten times above the upper limit of normal and if platelet counts were lower than 90 000 per μL, or if they had received interferon therapy or treatment with a nucleoside and nucleotide analogue within the preceding 6 months. Patients were randomly assigned by blinded stratified block randomisation (1:1) to receive 180 μg of peginterferon alfa-2a weekly plus either TDF (300 mg once daily) or placebo for 96 weeks. The primary endpoint was the percentage of patients with undetectable HDV RNA at the end of treatment assessed by intention to treat. The trials are registered as NCT00932971 and NCT01088659.
FINDINGS


Between June 24, 2009, and Feb 28, 2011, we randomly assigned 59 HDV RNA-positive patients to receive peginterferon alfa-2a plus TDF and 61 to receive peginterferon alfa-2a plus placebo, including 48 (40%) patients with cirrhosis to the two treatment groups (23 in the peginterferon alfa-2a plus TDF group and 25 in the peginterferon alfa-2a plus placebo group). The primary endpoint was achieved in 28 (48%) of 59 patients in the peginterferon alfa-2a plus TDF group and in 20 (33%) of 61 patients in the peginterferon alfa-2a plus placebo group (odds ratio 1·84, 95% CI 0·86-3·91, p=0·12). We recorded 944 adverse events (459 in the peginterferon alfa-2a plus TDF group and 485 in the peginterferon alfa-2a plus placebo group). The most common adverse events were haematological, behavioural (eg, fatigue), musculoskeletal, influenza-like syndromes, and psychiatric complaints.
INTERPRETATION


Addition of TDF resulted in no significant improvement in HDV RNA response rates at the end of treatment. These findings highlight that alternative treatment options are needed for hepatitis D.
FUNDING


The HepNet Study-House (a project of the German Liver Foundation founded by the German Liver Foundation, the German Ministry for Education and Research, and the German Center for Infectious Disease Research), Hoffmann-La Roche, and Gilead Sciences.",2019,"The most common adverse events were haematological, behavioural (eg, fatigue), musculoskeletal, influenza-like syndromes, and psychiatric complaints.
","['Between June 24, 2009, and Feb 28, 2011, we randomly assigned 59 HDV RNA-positive patients to receive', 'Patients with chronic HDV infection and compensated liver disease who were aged 18 years or older were eligible for inclusion', 'hepatitis D (HIDIT-II']","['tenofovir disoproxil fumarate (TDF', 'peginterferon alfa-2a weekly plus either TDF', 'peginterferon alfa-2a plus placebo', 'placebo', 'peginterferon alfa-2a plus TDF', 'peginterferon alfa', 'interferon therapy or treatment with a nucleoside and nucleotide analogue', 'peginterferon alfa-2a', 'Peginterferon alfa-2a plus tenofovir disoproxil fumarate', 'peginterferon']","['haematological, behavioural (eg, fatigue), musculoskeletal, influenza-like syndromes, and psychiatric complaints', 'HDV RNA response rates', 'hepatitis D virus (HDV) RNA suppression', 'percentage of patients with undetectable HDV RNA', 'alanine aminotransferase levels']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0205432', 'cui_str': 'Compensated (qualifier value)'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0011226', 'cui_str': 'Delta Infection'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0391001', 'cui_str': 'peginterferon alfa-2a'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0279030', 'cui_str': 'Interferon therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3884490', 'cui_str': '4-amino-3-(2-(6-cyano-2-naphthyl)ethynyl)-1-(2-deoxypentofuranosyl)-1H-pyrazolo(3,4-d)pyrimidine'}, {'cui': 'C0028630', 'cui_str': 'Nucleotides'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0486926', 'cui_str': 'Hepatitis D virus RNA'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",59.0,0.728827,"The most common adverse events were haematological, behavioural (eg, fatigue), musculoskeletal, influenza-like syndromes, and psychiatric complaints.
","[{'ForeName': 'Heiner', 'Initials': 'H', 'LastName': 'Wedemeyer', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany; German Center for Infectious Disease Research, HepNet Study-House, Hannover, Germany; Department of Gastroenterology and Hepatology, Essen University Hospital, Essen, Germany; Medical Faculty of the University of Duisburg-Essen, Essen, Germany. Electronic address: heiner.wedemeyer@uk-essen.de.'}, {'ForeName': 'Cihan', 'Initials': 'C', 'LastName': 'Yurdaydin', 'Affiliation': 'Department of Gastroenterology, Ankara University Medical School, Ankara, Turkey; Department of Internal Medicine, Koc University Medical School, Istanbul, Turkey.'}, {'ForeName': 'Svenja', 'Initials': 'S', 'LastName': 'Hardtke', 'Affiliation': 'German Center for Infectious Disease Research, HepNet Study-House, Hannover, Germany.'}, {'ForeName': 'Florin Alexandru', 'Initials': 'FA', 'LastName': 'Caruntu', 'Affiliation': 'Institutul de Boli Infectioase, Bucharest, Romania.'}, {'ForeName': 'Manuela G', 'Initials': 'MG', 'LastName': 'Curescu', 'Affiliation': 'Spitalul Clinic de Boli Infectioase si, Timisoara, Romania.'}, {'ForeName': 'Kendal', 'Initials': 'K', 'LastName': 'Yalcin', 'Affiliation': 'Dicle University Medical Faculty, Diyarbakir, Turkey.'}, {'ForeName': 'Ulus S', 'Initials': 'US', 'LastName': 'Akarca', 'Affiliation': 'Ege University Medical Faculty, Izmir, Turkey.'}, {'ForeName': 'Selim', 'Initials': 'S', 'LastName': 'Gürel', 'Affiliation': 'Uludağ University Medical Faculty, Bursa, Turkey.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Zeuzem', 'Affiliation': 'Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Erhardt', 'Affiliation': 'Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Lüth', 'Affiliation': 'University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'George V', 'Initials': 'GV', 'LastName': 'Papatheodoridis', 'Affiliation': 'School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Keskin', 'Affiliation': 'Department of Gastroenterology, Ankara University Medical School, Ankara, Turkey.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Port', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Radu', 'Affiliation': 'Institutul de Boli Infectioase, Bucharest, Romania.'}, {'ForeName': 'Mustafa K', 'Initials': 'MK', 'LastName': 'Celen', 'Affiliation': 'Dicle University Medical Faculty, Diyarbakir, Turkey.'}, {'ForeName': 'Ramazan', 'Initials': 'R', 'LastName': 'Idilman', 'Affiliation': 'Department of Gastroenterology, Ankara University Medical School, Ankara, Turkey.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Weber', 'Affiliation': 'Institute for Biometry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Stift', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Wittkop', 'Affiliation': 'Hannover Clinical Trial Center, Hannover, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Heidrich', 'Affiliation': 'German Center for Infectious Disease Research, HepNet Study-House, Hannover, Germany.'}, {'ForeName': 'Ingmar', 'Initials': 'I', 'LastName': 'Mederacke', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'von der Leyen', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany; Hannover Clinical Trial Center, Hannover, Germany.'}, {'ForeName': 'Hans Peter', 'Initials': 'HP', 'LastName': 'Dienes', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Cornberg', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Koch', 'Affiliation': 'Institute for Biometry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Manns', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany; German Center for Infectious Disease Research, HepNet Study-House, Hannover, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30663-7']
1235,30784635,"Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings: a pragmatic, stepped-wedge, cluster-randomised controlled trial.","BACKGROUND


In 2015, an estimated 303 000 women died in pregnancy and childbirth. Obstetric haemorrhage, sepsis, and hypertensive disorders of pregnancy account for more than 50% of maternal deaths worldwide. There are effective treatments for these pregnancy complications, but they require early detection by measurement of vital signs and timely administration to save lives. The primary aim of this trial was to determine whether implementation of the CRADLE Vital Sign Alert and an education package into community and facility maternity care in low-resource settings could reduce a composite of all-cause maternal mortality or major morbidity (eclampsia and hysterectomy).
METHODS


We did a pragmatic, stepped-wedge, cluster-randomised controlled trial in ten clusters across Africa, India, and Haiti, introducing the device into routine maternity care. Each cluster contained at least one secondary or tertiary hospital and their main referral facilities. Clusters crossed over from existing routine care to the CRADLE intervention in one of nine steps at 2-monthly intervals, with CRADLE devices replacing existing equipment at the randomly allocated timepoint. A computer-generated randomly allocated sequence determined the order in which the clusters received the intervention. Because of the nature of the intervention, this trial was not masked. Data were gathered monthly, with 20 time periods of 1 month. The primary composite outcome was at least one of eclampsia, emergency hysterectomy, and maternal death. This study is registered with the ISRCTN registry, number ISRCTN41244132.
FINDINGS


Between April 1, 2016, and Nov 30, 2017, among 536 223 deliveries, the primary outcome occurred in 4067 women, with 998 maternal deaths, 2692 eclampsia cases, and 681 hysterectomies. There was an 8% decrease in the primary outcome from 79·4 per 10 000 deliveries pre-intervention to 72·8 per 10 000 deliveries post-intervention (odds ratio [OR] 0·92, 95% CI 0·86-0·97; p=0·0056). After planned adjustments for variation in event rates between and within clusters over time, the unexpected degree of variability meant we were unable to judge the benefit or harms of the intervention (OR 1·22, 95% CI 0·73-2·06; p=0·45).
INTERPRETATION


There was an absolute 8% reduction in primary outcome during the trial, with no change in resources or staffing, but this reduction could not be directly attributed to the intervention due to variability. We encountered unanticipated methodological challenges with this trial design, which can provide valuable learning for future research and inform the trial design of future international stepped-wedge trials.
FUNDING


Newton Fund Global Research Programme: UK Medical Research Council; Department of Biotechnology, Ministry of Science & Technology, Government of India; and UK Department of International Development.",2019,"There was an absolute 8% reduction in primary outcome during the trial, with no change in resources or staffing, but this reduction could not be directly attributed to the intervention due to variability.","['Between April 1, 2016, and Nov 30, 2017, among 536\u2008223 deliveries', 'low-resource settings', 'In 2015, an estimated 303\u2008000', 'women died in pregnancy and childbirth', '4067 women, with 998 maternal deaths, 2692 eclampsia cases, and 681 hysterectomies']",['novel vital sign device'],"['maternal mortality and morbidity', 'least one of eclampsia, emergency hysterectomy, and maternal death', 'Obstetric haemorrhage, sepsis, and hypertensive disorders of pregnancy account']","[{'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C3494405', 'cui_str': 'Maternal Death'}, {'cui': 'C0013537', 'cui_str': 'Eclampsia'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}]","[{'cui': 'C0518766'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0024923', 'cui_str': 'Maternal Mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0013537', 'cui_str': 'Eclampsia'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C3494405', 'cui_str': 'Maternal Death'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",536223.0,0.375814,"There was an absolute 8% reduction in primary outcome during the trial, with no change in resources or staffing, but this reduction could not be directly attributed to the intervention due to variability.","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Vousden', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK. Electronic address: nicola.vousden@kcl.ac.uk.""}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lawley', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Muchabayiwa Francis', 'Initials': 'MF', 'LastName': 'Gidiri', 'Affiliation': 'Department of Obstetrics and Gynaecology, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Shivaprasad', 'Initials': 'S', 'LastName': 'Goudar', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belgaum, Karnataka, India.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Sandall', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Lucy C', 'Initials': 'LC', 'LastName': 'Chappell', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Global health,['10.1016/S2214-109X(18)30526-6']
1236,30784636,The effect of the Alive & Thrive initiative on exclusive breastfeeding in rural Burkina Faso: a repeated cross-sectional cluster randomised controlled trial.,"BACKGROUND


The benefits of exclusive breastfeeding on mortality, health, and development of children have been well documented. In Burkina Faso, the Alive & Thrive initiative combined interpersonal communication and community mobilisation activities with the aim of improving knowledge, beliefs, skills, and, ultimately, breastfeeding outcomes. The objective of this study was to determine the effect of the Alive & Thrive initiative on exclusive breastfeeding in Boucle du Mouhoun, Burkina Faso.
METHODS


We did a cluster-randomised trial with data collected with two independent, population-representative, cross-sectional surveys: a baseline survey done before the start of the initiative implementation and an endline survey done 2 years later. Rural villages in Boucle du Mouhoun, Burkina Faso, were randomly allocated by use of computer generated pseudo-random numbers, and women were eligible for participation if they had a livebirth in the 12 months preceding the survey and resided in a village selected for the study. The primary outcome was exclusive breastfeeding among infants younger than 6 months. Masking was not possible for the intervention implementation. All women who participated in the trial were included in the analysis population. The trial is registered with ClinicalTrials.gov, number NCT02435524.
FINDINGS


Between June 2 and July 28, 2015, 2288 mothers participated in the baseline survey and between June 12 and July 25, 2017, 2253 mothers participated in the endline survey. At endline, there was a risk difference of 38·9% (95% CI 32·2-45·6, p<0·001) between the reported prevalence of exclusive breastfeeding in the intervention group and that of the control group.
INTERPRETATION


A multidimensional intervention deliverable at scale in a low-income setting resulted in substantial increases in mothers' optimal breastfeeding knowledge and beliefs and in reported exclusive breastfeeding practices. However, it is possible that the findings might have been influenced by social desirability bias.
FUNDING


Bill & Melinda Gates Foundation, London School of Hygiene & Tropical Medicine.",2019,"At endline, there was a risk difference of 38·9% (95% CI 32·2-45·6, p<0·001) between the reported prevalence of exclusive breastfeeding in the intervention group and that of the control group.
","['Rural villages in Boucle du Mouhoun, Burkina Faso, were randomly allocated by use of computer generated pseudo-random numbers, and women were eligible for participation if they had a livebirth in the 12 months preceding the survey and resided in a village selected for the study', 'Between June 2 and July 28, 2015, 2288 mothers participated in the baseline survey and between June 12 and July 25, 2017, 2253 mothers participated in the endline survey', 'rural Burkina Faso', 'All women who participated in the trial were included in the analysis population']",[],['exclusive breastfeeding'],"[{'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],"[{'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}]",2288.0,0.121856,"At endline, there was a risk difference of 38·9% (95% CI 32·2-45·6, p<0·001) between the reported prevalence of exclusive breastfeeding in the intervention group and that of the control group.
","[{'ForeName': 'Jenny A', 'Initials': 'JA', 'LastName': 'Cresswell', 'Affiliation': 'MARCH Centre for Maternal, Adolescent, Reproductive & Child Health, London School of Hygiene & Tropical Medicine, London, UK. Electronic address: jenny.cresswell@lshtm.ac.uk.'}, {'ForeName': 'Rasmané', 'Initials': 'R', 'LastName': 'Ganaba', 'Affiliation': 'AFRICSanté, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Sarrassat', 'Affiliation': 'MARCH Centre for Maternal, Adolescent, Reproductive & Child Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Somé', 'Affiliation': 'AFRICSanté, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Abdoulaye Hama', 'Initials': 'AH', 'LastName': 'Diallo', 'Affiliation': 'Centre MURAZ, Bobo-Dioulasso, Burkina Faso; Université Ouaga I Pr Joseph Ki-Zerbo, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Cousens', 'Affiliation': 'MARCH Centre for Maternal, Adolescent, Reproductive & Child Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Filippi', 'Affiliation': 'MARCH Centre for Maternal, Adolescent, Reproductive & Child Health, London School of Hygiene & Tropical Medicine, London, UK.'}]",The Lancet. Global health,['10.1016/S2214-109X(18)30494-7']
1237,15985728,Indigenous recombinant streptokinase vs natural streptokinase in acute myocardial infarction patients: Phase III multicentric randomized double blind trial.,"BACKGROUND


Streptokinase is the most widely used thrombolytic agent and can now be made using recombinant DNA technology. The present trial was initiated to assess an indigenous recombinant streptokinase (Shankinase, r-SK).
AIM


To compare the efficacy and safety of indigenous recombinant streptokinase (Shankinase, r-SK) and natural streptokinase (Streptase, n-SK).
SETTINGS AND DESIGN


Double blind, randomized, non-inferiority, multicentric, parallel study.
MATERIALS AND METHODS


Patients of AMI < 6 hours of chest pain and 2 mm ST elevation in 2 contiguous chest leads V(1)-V(6) or 1 mm in limb leads were randomized to receive 1.5 miu of either r-SK or n-SK. CK Peaking and decrease of > or = 50% ST segment were used to assess reperfusion.
STATISTICAL ANALYSIS


Difference in the groups was assessed by chi-square or paired t test as required. Probability value < 0.05 was considered significant with 95% confidence interval.
RESULTS


Overall 150 patients were recruited (96 r-SK group and 54 in n-SK group) and demographic and clinical profile of the groups was comparable. Reperfusion was seen in 68.2% (58) and 69.4% (34) patients in r-SK and n-SK groups respectively. Commonly seen adverse events were fever in 7 (8.5%), hypotension in 3 (3.6%), nausea in 2 (2.4%) patients. Minor bleeding were seen in 4 (4.8%) of patients.
CONCLUSION


Indigenous recombinant Streptokinase (r-SK) is as efficacious as natural streptokinase (n-SK) in establishing reperfusion as assessed by non-invasive parameters with comparable side effect profile.",2005,Indigenous recombinant Streptokinase (r-SK) is as efficacious as natural streptokinase (n-SK) in establishing reperfusion as assessed by non-invasive parameters with comparable side effect profile.,"['acute myocardial infarction patients', 'Patients of AMI', 'Overall 150 patients']","['Indigenous recombinant streptokinase vs natural streptokinase', 'indigenous recombinant streptokinase (Shankinase, r-SK) and natural streptokinase (Streptase, n-SK', 'indigenous recombinant streptokinase (Shankinase, r-SK', 'Indigenous recombinant Streptokinase (r-SK']","['efficacy and safety', 'nausea', 'hypotension', 'Reperfusion', 'Minor bleeding']","[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0038418', 'cui_str': 'Streptokinase'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0699213', 'cui_str': 'Streptase'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0026193', 'cui_str': 'Minors'}]",150.0,0.414366,Indigenous recombinant Streptokinase (r-SK) is as efficacious as natural streptokinase (n-SK) in establishing reperfusion as assessed by non-invasive parameters with comparable side effect profile.,"[{'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Diwedi', 'Affiliation': 'Department of Cardiology K.G.M.C. Hospital, Lucknow, India.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Hiremath', 'Affiliation': ''}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Kerkar', 'Affiliation': ''}, {'ForeName': 'Krishna N', 'Initials': 'KN', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'C N', 'Initials': 'CN', 'LastName': 'Manjunath', 'Affiliation': ''}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Ramesh', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Prabhavati', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dhobe', 'Affiliation': ''}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bhusari', 'Affiliation': ''}, {'ForeName': 'Raman', 'Initials': 'R', 'LastName': 'Rao', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1238,30239113,Regional anesthesia with epinephrine-containing lidocaine reduces pericatheter bleeding after tunneled hemodialysis catheter placement.,"INTRODUCTION


Pericatheter bleeding (PB) following tunneled hemodialysis catheter (THC) placement is a common phenomenon. In addition to complicating securement of the THC, the PB may loosen the adhesive catheter dressing and delay wound healing. The primary aim of this study was to determine whether epinephrine-containing local anesthetics rather than plain ones reduce superficial PB after THC placement.
METHODS


The study was based on the retrospective analysis of the prospectively gathered data. Forty-six patients receiving local analgesia during THC placement were randomly assigned in a double-blind manner to two groups according to local anesthetic mixtures used (n =22 to prilocaine group [group 1]; n =24 to epinephrine-containing lidocaine group [group 2]). Presence or absence of PB after the THC placement was evaluated. Differences between groups with and without controlling other variables were statistically analyzed.
FINDINGS


Epinephrine-containing lidocaine (group 2) significantly reduced PB in comparison with prilocaine, P = 0.003. Use of epinephrine-containing lidocaine (group 2) was associated with a reduction in the likelihood of PB (Odds ratio = 0.017). Meanwhile, use of prilocaine (group 1) had 59.7 times higher odds in the likelihood of PB after THC placement. Lower rate of systolic blood pressure (SBP) in group 2 patients after 5 minutes of injections was also noted, P = 0.008. Epinephrine-containing lidocaine was well tolerated and caused no significant cardiovascular disturbance.
DISCUSSION


Local infiltration of epinephrine-containing lidocaine instead of plain local anesthetics during THC insertion may reduce superficial PB and improve patient comfort.",2019,"FINDINGS


Epinephrine-containing lidocaine (group 2) significantly reduced PB in comparison with prilocaine, P = 0.003.","['after tunneled hemodialysis catheter placement', 'Forty-six patients receiving local analgesia during THC placement']","['tunneled hemodialysis catheter (THC) placement', 'local anesthetic mixtures', 'epinephrine-containing lidocaine', 'epinephrine-containing local anesthetics rather than plain', 'prilocaine', 'Epinephrine-containing lidocaine']","['pericatheter bleeding', 'PB', 'superficial PB', 'Lower rate of systolic blood pressure (SBP']","[{'cui': 'C0179760', 'cui_str': 'Hemodialysis catheter'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}]","[{'cui': 'C0179760', 'cui_str': 'Hemodialysis catheter'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}]","[{'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]",46.0,0.112234,"FINDINGS


Epinephrine-containing lidocaine (group 2) significantly reduced PB in comparison with prilocaine, P = 0.003.","[{'ForeName': 'Ilhan Nahit', 'Initials': 'IN', 'LastName': 'Mutlu', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Istanbul Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Burak', 'Initials': 'B', 'LastName': 'Kocak', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Istanbul Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Melis', 'Initials': 'M', 'LastName': 'Baykara Ulusan', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Istanbul Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Kivilcim', 'Initials': 'K', 'LastName': 'Ulusan', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Istanbul Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mehmet Semih', 'Initials': 'MS', 'LastName': 'Cakir', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Istanbul Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ozgur', 'Initials': 'O', 'LastName': 'Kilickesmez', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Istanbul Training and Research Hospital, Istanbul, Turkey.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12686']
1239,30769227,Effects of adjuvant tamoxifen over three decades on breast cancer-free and distant recurrence-free interval among premenopausal women with oestrogen receptor-positive breast cancer randomised in the Swedish SBII:2pre trial.,"AIMS


The primary aim was to compare 2 years of adjuvant tamoxifen versus no systemic treatment in premenopausal patients with oestrogen receptor (ER)-positive tumours, regarding breast cancer-free interval (BCFi) and distant recurrence-free interval (D-RFi), with 30 years of follow-up and for specified intervals. Moreover, we aimed to investigate the effects of adjuvant tamoxifen on the incidence of secondary malignancies and survival after distant recurrence.
METHODS


Premenopausal patients with primary breast cancer were randomised to 2 years of tamoxifen (n = 277) or no systemic treatment (n = 287), irrespective of ER status. Information regarding events was collected by a review of medical records and from national registers.
RESULTS


The median follow-up for all patients without events was 28 years, and only four of the patients alive had a follow-up of <20 years. With 30 years of follow-up, tamoxifen prolonged BCFi in the intention-to-treat population (hazard ratio [HR] = 0.76, 95% confidence interval (CI) 0.61-0.94, p = 0.011) compared with no treatment. In patients with ER-positive tumours (n = 362), tamoxifen prolonged BCFi (HR = 0.62, 95% CI 0.47-0.82, p = 0.001) and D-RFi (HR = 0.73, 95% CI 0.54-0.99, p = 0.043). The positive effect on BCFi was significant also for the interval >15-30 years (HR = 0.53, 95% CI 0.28-0.98, p = 0.042). For patients with ER-positive tumours who were diagnosed with distant recurrence (n = 165), survival after distant recurrence was shorter among tamoxifen-treated patients (median, 29 months versus 43 months). The incidence of contralateral breast cancer was 42% lower in the tamoxifen group (HR = 0.58, 95% CI 0.35-0.96, p = 0.035), whereas no differences were observed regarding other secondary malignancies.
CONCLUSIONS


With three decades of follow-up, 2 years of adjuvant tamoxifen reduced the incidence of breast cancer-related events and distant recurrence, and the carryover effect seems to extend beyond 15 years. Moreover, adjuvant tamoxifen seems to be associated with shorter survival after diagnosis of distant recurrence.",2019,"2 years of adjuvant tamoxifen reduced the incidence of breast cancer-related events and distant recurrence, and the carryover effect seems to extend beyond 15 years.","['premenopausal patients with oestrogen receptor (ER)-positive tumours, regarding breast cancer-free interval (BCFi) and distant recurrence-free interval (D-RFi), with 30 years of follow-up and for specified intervals', 'Premenopausal patients with primary breast cancer', 'premenopausal women with oestrogen receptor-positive breast cancer randomised in the Swedish SBII:2pre trial']","['tamoxifen (n\xa0=\xa0277) or no systemic treatment', 'tamoxifen', 'adjuvant tamoxifen']","['distant recurrence', 'survival after distant recurrence', 'breast cancer-free and distant recurrence-free interval', 'incidence of contralateral breast cancer', 'shorter survival', 'BCFi', 'incidence of breast cancer-related events and distant recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1562312', 'cui_str': 'Estrogen receptor positive tumor'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2938924', 'cui_str': 'Oestrogen receptor positive breast cancer'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1096616', 'cui_str': 'Contralateral breast cancer'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.361185,"2 years of adjuvant tamoxifen reduced the incidence of breast cancer-related events and distant recurrence, and the carryover effect seems to extend beyond 15 years.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ekholm', 'Affiliation': 'Department of Oncology, Jönköping, Region Jönköping County, and Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden; Department of Clinical Sciences Lund, Division of Oncology and Pathology, Lund University, Lund, Sweden. Electronic address: maria.ekholm@med.lu.se.'}, {'ForeName': 'P O', 'Initials': 'PO', 'LastName': 'Bendahl', 'Affiliation': 'Department of Clinical Sciences Lund, Division of Oncology and Pathology, Lund University, Lund, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fernö', 'Affiliation': 'Department of Clinical Sciences Lund, Division of Oncology and Pathology, Lund University, Lund, Sweden.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Nordenskjöld', 'Affiliation': 'Department of Clinical and Experimental Medicine and Department of Oncology, Linköping University, Linköping, Sweden.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Stål', 'Affiliation': 'Department of Clinical and Experimental Medicine and Department of Oncology, Linköping University, Linköping, Sweden.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rydén', 'Affiliation': 'Department of Clinical Sciences Lund, Division of Surgery, Lund University, Lund, Sweden; Department of Surgery and Gastroenterology, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2018.12.034']
1240,31216086,"Deferred treatment with a fixed-dose combination of sofosbuvir-velpatasvir for chronic hepatitis C virus genotype 1, 2, 4 and 6 infection.","Sofosbuvir-velpatasvir is approved for the treatment of chronic hepatitis C virus (HCV) infection. In this single-arm, open-label, phase 3, deferred treatment study, we investigated the efficacy and safety of sofosbuvir-velpatasvir among patients randomized to the placebo group in the ASTRAL-1 study. Patients received sofosbuvir-velpatasvir (400/100 mg) once daily for 12 weeks. The primary efficacy endpoint was the proportion of patients with sustained virologic response 12 weeks after the end of therapy (SVR12). The primary safety endpoint was any adverse events (AEs) leading to the permanent discontinuation of study drug. Overall, 108/111 (97%, 95% confidence interval [CI], 92%-99%) achieved SVR12, and only one patient had virological failure. SVR12 was achieved by 61/63 (97%, 95%CI, 89%-100%) genotype 1 patients, 20/20 (100%; 95%CI, 83%-100%) with genotype 2, 19/19 (100%; 95%CI, 82%-100%) with genotype 4 and 8/9 (89%; 95% CI, 52%-100%) with genotype 6. All (19/19; 95%CI, 82-100) patients with cirrhosis and all (31/31, 95%CI, 89-100) with prior treatment experience achieved SVR12. The safety profile during treatment was similar to that observed in patients receiving placebo treatment. The most common AEs were headache, fatigue and nausea. One patient (1%) discontinued treatment due to an AE of gallbladder carcinoma, which was not considered related to treatment. Of five reported serious AEs, none were considered related to study drug. Sofosbuvir-velpatasvir for 12 weeks was effective and well tolerated among untreated and previously treated patients with HCV genotype 1, 2, 4 or 6 infection, including those with compensated cirrhosis (ClinicalTrials.gov NCT02346721).",2019,"SVR12 was achieved by 61/63 (97%, 95%CI, 89-100%) genotype 1 patients, 20/20 (100%; 95%CI, 83-100%) with genotype 2, 19/19 (100%; 95%CI, 82-100%) with genotype 4, and 8/9 (89%; 95% CI, 52-100%) with genotype 6.",[],"['placebo', 'sofosbuvir-velpatasvir']","['proportion of patients with sustained virologic response', 'headache, fatigue, and nausea', 'SVR12', 'SVR12.The safety profile', 'effective and well-tolerated', 'efficacy and safety', 'adverse events (AEs) leading to the permanent discontinuation of study drug', 'virological failure']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C4079582', 'cui_str': 'velpatasvir'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",100.0,0.418454,"SVR12 was achieved by 61/63 (97%, 95%CI, 89-100%) genotype 1 patients, 20/20 (100%; 95%CI, 83-100%) with genotype 2, 19/19 (100%; 95%CI, 82-100%) with genotype 4, and 8/9 (89%; 95% CI, 52-100%) with genotype 6.","[{'ForeName': 'Tarik', 'Initials': 'T', 'LastName': 'Asselah', 'Affiliation': 'Hepatology Department, Head of Viral Hepatitis Team, INSERM UMR1149, Beaujon Hospital, Université Paris Diderot, Paris, France.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Shafran', 'Affiliation': 'University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bourgeois', 'Affiliation': 'Ziekenhuis Netwerk Antwerpen STER Site Stuivenberg, Antwerpen, Belgium.'}, {'ForeName': 'Ching-Lung', 'Initials': 'CL', 'LastName': 'Lai', 'Affiliation': 'The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Mathurin', 'Affiliation': 'Hôpital Claude Huriez, Lille, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Willems', 'Affiliation': 'Université de Montréal, Québec, Canada.'}, {'ForeName': 'Mindie H', 'Initials': 'MH', 'LastName': 'Nguyen', 'Affiliation': 'Stanford University Medical Center, Stanford, California, USA.'}, {'ForeName': 'Mitchell N', 'Initials': 'MN', 'LastName': 'Davis', 'Affiliation': 'South Florida Center of Gastroenterology, Wellington, Florida, USA.'}, {'ForeName': 'K C', 'Initials': 'KC', 'LastName': 'Huang', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California, USA.'}, {'ForeName': 'Evguenia', 'Initials': 'E', 'LastName': 'Svarovskaia', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California, USA.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Osinusi', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McNally', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California, USA.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Brainard', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California, USA.'}, {'ForeName': 'Obaid S', 'Initials': 'OS', 'LastName': 'Shaikh', 'Affiliation': 'VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Tram T', 'Initials': 'TT', 'LastName': 'Tran', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California, USA.'}]",Journal of viral hepatitis,['10.1111/jvh.13159']
1241,30815995,Microwave ablation vs. parathyroidectomy for secondary hyperparathyroidism in maintenance hemodialysis patients.,"INTRODUCTION


Secondary hyperparathyroidism (SHPT) is a serious and common problem in patients undergoing maintenance hemodialysis. Minimally invasive microwave ablation (MWA) has been used to treat SHPT and shows some advantages. However, its efficacy is still undefined. The primary purpose of this study was to determine the efficacy and safety of MWA compared to total parathyroidectomy plus forearm autotransplantation.
METHODS


The SHPT patients who were undergoing maintenance hemodialysis (follow-up for 6 to 24 months after treatments) were divided into a MWA group (n = 33) and a parathyroidectomy group (n = 48). The efficacy (serum intact parathyroid hormone [iPTH], calcium, and phosphorus levels) and safety (hoarseness, hypocalcaemia, and persistently low iPTH) were compared between the two groups. Additionally, the study explored potential predictors of response to MWA by a logistic regression analysis.
FINDINGS


There were no significant differences in baseline characteristics between the two groups. The rates of achieving the recommended goal for iPTH were significantly higher in the MWA group than that in the parathyroidectomy group at all follow-up times: 57.58% vs. 12.50% at one-day (P < 0.001), 45.45% vs. 16.67% at 1-week (P = 0.005), 57.58% vs. 16.67% at 2-week (P < 0.001), 57.58% vs. 22.92% at 1-month (P = 0.002), and 69.70% vs. 35.42% at 3-month (P = 0.002), 76.47% vs. 28.57% at 6-month (P = 0.005), 87.50% vs. 47.37% at 12-month (P = 0.008), and 81.82% vs. 52.63% at 24-month (P = 0.015), respectively. However, there were no significant differences for phosphorus or calcium at any of the follow-up times (P > 0.05). The persistently low iPTH was more in the parathyroidectomy group (64.6%) than that in the MWA group (0%) (P < 0.001), but there was no significant difference in hoarseness or hypocalcaemia (P > 0.05). Baseline levels of iPTH (P = 0.021) and patient age (P = 0.011) were determined as predictors by univariate logistic regression analysis.
CONCLUSION


The MWA could be an alternative to parathyroidectomy for SHPT but its eventual superiority has to be demonstrated by a proper study.",2019,"Baseline levels of iPTH (P = 0.021) and patient age (P = 0.011) were determined as predictors by univariate logistic regression analysis.
","['maintenance hemodialysis patients', 'The SHPT patients who were undergoing maintenance hemodialysis (follow-up for 6 to 24\u2009months after treatments', 'patients undergoing maintenance hemodialysis']","['total parathyroidectomy plus forearm autotransplantation', 'parathyroidectomy', 'Microwave ablation vs. parathyroidectomy', 'Minimally invasive microwave ablation (MWA', 'MWA']","['phosphorus or calcium', 'hoarseness or hypocalcaemia', 'efficacy and safety', 'efficacy (serum intact parathyroid hormone [iPTH], calcium, and phosphorus levels) and safety (hoarseness, hypocalcaemia, and persistently low iPTH', 'Baseline levels of iPTH', 'rates of achieving the recommended goal for iPTH']","[{'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}]","[{'cui': 'C0193696', 'cui_str': 'Complete parathyroidectomy (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}, {'cui': 'C3854551', 'cui_str': 'Microwave ablation'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}]","[{'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0019825', 'cui_str': 'Voice Hoarseness'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0047008', 'cui_str': 'IPTHS'}, {'cui': 'C0018017', 'cui_str': 'Goals'}]",,0.0218008,"Baseline levels of iPTH (P = 0.021) and patient age (P = 0.011) were determined as predictors by univariate logistic regression analysis.
","[{'ForeName': 'Binghu', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'Department of Radiology, Nanchong Central Hospital, The Second Clinical Medical College, North Sichuan Medical College, Nanchong, China.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, BenQ Medical Center, The Affiliated BenQ Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'Department of Ultrasonography, BenQ Medical Center, The Affiliated BenQ Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Hongfei', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Urology, BenQ Medical Center, The Affiliated BenQ Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Leijuan', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Nephrology, BenQ Medical Center, The Affiliated BenQ Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Gong', 'Affiliation': 'Department of Ultrasonography, BenQ Medical Center, The Affiliated BenQ Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Zhanhui', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'Department of Nephrology, BenQ Medical Center, The Affiliated BenQ Hospital of Nanjing Medical University, Nanjing, China.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12740']
1242,30811543,Disseminating Tai Chi in the Community: Promoting Home Practice and Improving Balance.,"BACKGROUND AND OBJECTIVES


Falls among older adults is a pressing public health challenge. Considerable research documents that longer tai chi courses can reduce falls and improve balance. However, longer courses can be challenging to implement. Our goal was to evaluate whether a short 6-week modified tai chi course could be effective at reducing falls risk if older adults designed a personal home practice plan to receive a greater tai chi ""dose"" during the 6 weeks.
DESIGN


A 3-city wait-listed randomized trial was conducted. Habituation Intention and Social Cognitive Theories framed the ""coaching"" strategy by which participants designed practice plans. RE-AIM and Treatment Fidelity Frameworks were used to evaluate implementation and dissemination issues. Three advisory groups advised the study on intervention planning, implementation, and evaluation. To measure effectiveness, we used Centers for Disease Control and Prevention recommended measures for falls risk including leg strength, balance, and mobility and gait. In addition, we measured balance confidence and executive function.
RESULTS


Program Implementation resulted in large class sizes, strong participant retention, high program fidelity and effectiveness. Participants reported practicing an average of 6 days a week and more than 25 min/day. Leg strength, tandem balance, mobility and gait, balance confidence, and executive function were significantly better for the experimental group than control group.
CONCLUSION


The tai chi short course resulted in substantial tai chi practice by older adults outside of class as well as better physical and executive function. The course reach, retention, fidelity, and implementation across 3 cities suggest strong potential for implementation and dissemination of the 6-week course.",2020,"Leg strength, tandem balance, mobility and gait, balance confidence, and executive function were significantly better for the experimental group than control group.
",['older adults'],['tai chi'],"['large class sizes, strong participant retention, high program fidelity and effectiveness', 'Leg strength, tandem balance, mobility and gait, balance confidence, and executive function', 'balance confidence and executive function', 'course reach, retention, fidelity, and implementation', 'falls risk including leg strength, balance, and mobility and gait', 'substantial tai chi practice']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0376403', 'cui_str': 'Taiji'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0557314', 'cui_str': 'Number of pupils in class (observable entity)'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}]",,0.0343028,"Leg strength, tandem balance, mobility and gait, balance confidence, and executive function were significantly better for the experimental group than control group.
","[{'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Chewning', 'Affiliation': 'Social and Administrative Sciences Division, School of Pharmacy.'}, {'ForeName': 'Kristine M', 'Initials': 'KM', 'LastName': 'Hallisy', 'Affiliation': 'Doctor of Physical Therapy Program, Department of Family Medicine and Community Health.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Mahoney', 'Affiliation': 'Division of Geriatrics, Department of Medicine, School of Medicine and Public Health.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Wilson', 'Affiliation': 'Social and Administrative Sciences Division, School of Pharmacy.'}, {'ForeName': 'Nisaratana', 'Initials': 'N', 'LastName': 'Sangasubana', 'Affiliation': 'Sonderegger Research Center, School of Pharmacy.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Gangnon', 'Affiliation': 'Population Health, Department of Population Health Sciences.'}]",The Gerontologist,['10.1093/geront/gnz006']
1243,25646022,The Efficacy of a Brief Behavioral Sleep Intervention in School-Aged Children With ADHD and Comorbid Autism Spectrum Disorder.,"OBJECTIVE


Sleep problems are common in children with autism spectrum disorders (ASD) and ADHD and impact adversely on child and parent well-being. The study evaluated the efficacy of a brief behavioral sleep intervention in children with comorbid ADHD-ASD.
METHOD


A subsample of children with ADHD-ASD ( n = 61; 5-13 years; 89% male) participating in the Sleeping Sound With ADHD study were included in the current investigation. The subsample comprised of 28 children randomized to the sleep intervention group, while 33 were randomized to usual clinical care. The intervention consisted of two clinical consultations and a follow-up phone call covering sleep hygiene and standardized behavioral strategies.
RESULTS


Children with ADHD-ASD who received the intervention had large improvements in sleep problems and moderate improvements in child behavioral functioning 3 and 6 months post-randomization.
CONCLUSION


These findings suggest that a brief behavioral sleep intervention can improve sleep problems in children with ADHD-ASD.",2019,"RESULTS


Children with ADHD-ASD who received the intervention had large improvements in sleep problems and moderate improvements in child behavioral functioning 3 and 6 months post-randomization.
","['children with comorbid ADHD-ASD', 'children with autism spectrum disorders (ASD', 'children with ADHD-ASD', 'Children with ADHD-ASD', 'A subsample of children with ADHD-ASD ( n = 61; 5-13 years; 89% male) participating in the Sleeping Sound', 'School-Aged Children With ADHD and Comorbid Autism']","['clinical consultations and a follow-up phone call covering sleep hygiene and standardized behavioral strategies', 'sleep intervention', 'behavioral sleep intervention', 'Brief Behavioral Sleep Intervention']","['sleep problems', 'child behavioral functioning']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",28.0,0.0377517,"RESULTS


Children with ADHD-ASD who received the intervention had large improvements in sleep problems and moderate improvements in child behavioral functioning 3 and 6 months post-randomization.
","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Papadopoulos', 'Affiliation': '1 Deakin University, Burwood, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sciberras', 'Affiliation': ""2 Murdoch Children's Research Institute, Melbourne, Australia.""}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Hiscock', 'Affiliation': ""2 Murdoch Children's Research Institute, Melbourne, Australia.""}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Mulraney', 'Affiliation': ""2 Murdoch Children's Research Institute, Melbourne, Australia.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'McGillivray', 'Affiliation': '1 Deakin University, Burwood, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Rinehart', 'Affiliation': '1 Deakin University, Burwood, Australia.'}]",Journal of attention disorders,['10.1177/1087054714568565']
1244,31729825,Primary baerveldt versus trabeculectomy study after 5 years of follow-up.,"PURPOSE


Although the Baerveldt glaucoma implant (BGI) initially was reserved for refractory glaucoma, its role in the surgical management of glaucoma has shifted towards a primary treatment choice. We performed a randomized prospective study to compare BGI surgery and trabeculectomy (TE) in patients without previous ocular surgery.
METHODS


We included 119 glaucoma patients without previous ocular surgery. One eye of each subject was randomized to either a BGI or TE. Follow-up visits were at 1 day, 2 weeks, 6 weeks, 3 months, 6 months and 1, 2, 3, 4 and 5 years postoperatively. Primary outcomes were intraocular pressure (IOP) and failure rate. Secondary outcomes were medication, anterior chamber laser flare value and complications.
RESULTS


After 5 years, an IOP of 12.7 ± 3.9 mmHg (mean ± SD) was achieved in the TE group and 12.9 ± 3.9 mmHg in the BGI group. We found no statistically significant difference in failure rate between the groups (p = 0.72). More BGI patients needed additional medication to control their IOP (85%; 1.9 ± 1.2 types of glaucoma medication) compared to the TE patients (57%; 0.5 ± 0.9 types of glaucoma medication). Diplopia was significantly more present in the BGI group than in the TE group (27% versus 4%; p < 0.001). The self-limiting complication rate was similar in both groups.
CONCLUSIONS


Our study demonstrates that, in the long term, the final IOP and failure rate are similar after TE and BGI surgery. However, the need for additional medication after BGI surgery is higher than after TE. Also, the increased risk of developing diplopia after BGI surgery must be taken into consideration.",2020,We found no statistically significant difference in failure rate between the groups (p = 0.72).,"['patients without previous ocular surgery', '119 glaucoma patients without previous ocular surgery']","['BGI or TE', 'BGI surgery and trabeculectomy (TE']","['medication, anterior chamber laser flare value and complications', 'Diplopia', 'self-limiting complication rate', 'intraocular pressure (IOP) and failure rate', 'failure rate', 'final IOP and failure rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1705869', 'cui_str': 'Ophthalmic surgery (qualifier value)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}]","[{'cui': 'C0003151', 'cui_str': 'Anterior Chamber'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0012569', 'cui_str': 'Double Vision'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}]",119.0,0.0647951,We found no statistically significant difference in failure rate between the groups (p = 0.72).,"[{'ForeName': 'Esma', 'Initials': 'E', 'LastName': 'Islamaj', 'Affiliation': 'Rotterdam Eye Hospital, Rotterdam Ophthalmic Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'René J', 'Initials': 'RJ', 'LastName': 'Wubbels', 'Affiliation': 'Rotterdam Eye Hospital, Rotterdam Ophthalmic Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Peter W T', 'Initials': 'PWT', 'LastName': 'de Waard', 'Affiliation': 'Glaucoma Department, Rotterdam Eye Hospital, Rotterdam, The Netherlands.'}]",Acta ophthalmologica,['10.1111/aos.14265']
1245,25646023,Effects of Physical Exercise Intervention on Motor Skills and Executive Functions in Children With ADHD: A Pilot Study.,"OBJECTIVE


This study examined the effect of a 12-week table tennis exercise on motor skills and executive functions in children with ADHD.
METHOD


Fifteen children with ADHD received the intervention, whereas 15 children with ADHD and 30 typically developing children did not. The Test of Gross Motor Development-2, Stroop, and Wisconsin Card Sorting Test (WCST) were conducted before and after the intervention.
RESULTS


After the intervention, the ADHD training group scored significantly higher in the locomotor as well as object-control skills, Stroop Color-Word condition, and WCST total correct performance compared with the ADHD non-training group, and we noted improvements in the locomotor as well as object-control skills, Stroop Color-Word condition, and three aspects of the WCST performances of the ADHD training group over time.
CONCLUSION


A 12-week table tennis exercise may have clinical relevance in motor skills and executive functions of children with ADHD.",2019,"After the intervention, the ADHD training group scored significantly higher in the locomotor as well as object-control skills, Stroop Color-Word condition, and WCST total correct performance compared with the ADHD non-training group, and we noted improvements in the locomotor as well as object-control skills, Stroop Color-Word condition, and three aspects of the WCST performances of the ADHD training group over time.
","['Children With ADHD', 'Fifteen children with ADHD received the intervention, whereas 15 children with ADHD and 30 typically developing children did not', 'children with ADHD']","['Physical Exercise Intervention', 'ADHD training', 'table tennis exercise']","['Motor Skills and Executive Functions', 'locomotor as well as object-control skills, Stroop Color-Word condition, and three aspects of the WCST performances', 'locomotor as well as object-control skills, Stroop Color-Word condition, and WCST total correct performance', 'motor skills and executive functions', 'Gross Motor Development-2, Stroop, and Wisconsin Card Sorting Test (WCST']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1706074', 'cui_str': 'Table'}, {'cui': 'C0039515', 'cui_str': 'Tennis'}]","[{'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",15.0,0.0121317,"After the intervention, the ADHD training group scored significantly higher in the locomotor as well as object-control skills, Stroop Color-Word condition, and WCST total correct performance compared with the ADHD non-training group, and we noted improvements in the locomotor as well as object-control skills, Stroop Color-Word condition, and three aspects of the WCST performances of the ADHD training group over time.
","[{'ForeName': 'Chien-Yu', 'Initials': 'CY', 'LastName': 'Pan', 'Affiliation': '1 National Kaohsiung Normal University, Kaohsiung, Taiwan.'}, {'ForeName': 'Chia-Liang', 'Initials': 'CL', 'LastName': 'Tsai', 'Affiliation': '2 National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Chia-Hua', 'Initials': 'CH', 'LastName': 'Chu', 'Affiliation': '1 National Kaohsiung Normal University, Kaohsiung, Taiwan.'}, {'ForeName': 'Ming-Chih', 'Initials': 'MC', 'LastName': 'Sung', 'Affiliation': '1 National Kaohsiung Normal University, Kaohsiung, Taiwan.'}, {'ForeName': 'Chu-Yang', 'Initials': 'CY', 'LastName': 'Huang', 'Affiliation': '1 National Kaohsiung Normal University, Kaohsiung, Taiwan.'}, {'ForeName': 'Wei-Ya', 'Initials': 'WY', 'LastName': 'Ma', 'Affiliation': '1 National Kaohsiung Normal University, Kaohsiung, Taiwan.'}]",Journal of attention disorders,['10.1177/1087054715569282']
1246,30799142,Effect of Novartis Access on availability and price of non-communicable disease medicines in Kenya: a cluster-randomised controlled trial.,"BACKGROUND


Novartis Access is a Novartis programme that offers a portfolio of non-communicable disease medicines at a wholesale price of US$1 per treatment per month in low-income and middle-income countries. We evaluated the effect of Novartis Access in Kenya, the first country to receive the programme.
METHODS


We did a cluster-randomised controlled trial in eight counties in Kenya. Counties (clusters) were randomly assigned to the intervention or the control group with a covariate-constrained randomisation procedure that maximised balance on a set of demographic and health variables. In intervention counties, public and non-profit health facilities were allowed to purchase Novartis Access medicines from the Mission for Essential Drugs and Supplies (MEDS). Data were collected from all facilities served by MEDS and a sample of households in study counties. Households were eligible if they had at least one adult patient who had been diagnosed and prescribed medicines for one of the non-communicable diseases targeted by the programme: hypertension, heart failure, dyslipidaemia, type 2 diabetes, asthma, or breast cancer. Primary outcomes were availability and price of portfolio medicines at health facilities, irrespective of brand; and availability of medicines at patient households. Impacts were estimated with intention-to-treat analysis. This trial is registered with ClinicalTrials.gov (NCT02773095).
FINDINGS


On March 8, 2016, we randomly assigned eight clusters to intervention (four clusters; 74 health facilities; 342 patients) or control (four clusters; 63 health facilities; 297 patients). 69 intervention and 58 control health facilities, and 306 intervention and 265 control patients were evaluated after a 15 month intervention period (last visit February 28, 2018). Novartis Access significantly increased the availability of amlodipine (adjusted odds ratio [aOR] 2·84, 95% CI 1·10 to 7·37; p=0·031) and metformin (aOR 4·78, 95% CI 1·44 to 15·86; p=0·011) at health facilities, but did not affect the availability of portfolio medicines overall (adjusted β [aβ] 0·05, 95% CI -0·01 to 0·10; p=0·096) or their price (aβ 0·48, 95% CI -1·12 to 0·72; p=0·500). The programme did not affect medicine availability at patient households (aOR 0·83, 95% CI 0·44 to 1·57; p=0·569).
INTERPRETATION


Novartis Access had little effect in its first year in Kenya. Access programmes operate within complex health systems and reducing the wholesale price of medicines might not always or immediately translate to improved patient access. The evidence generated by this study will inform Novartis's efforts to improve their programme going forward. The study also contributes to the public evidence base on strategies for improving access to medicines globally.
FUNDING


Sandoz International (a subsidiary of Novartis International).",2019,"The programme did not affect medicine availability at patient households (aOR 0·83, 95% CI 0·44 to 1·57; p=0·569).
","['eight counties in Kenya', '69 intervention and 58 control health facilities, and 306 intervention and 265 control patients', 'Households were eligible if they had at least one adult patient who had been diagnosed and prescribed medicines for one of the non-communicable diseases targeted by the programme: hypertension, heart failure, dyslipidaemia, type 2 diabetes, asthma, or breast cancer', 'Counties (clusters', 'Kenya']","['control group with a covariate-constrained randomisation procedure that maximised balance', 'amlodipine', 'Novartis Access', 'metformin']","['availability and price of portfolio medicines at health facilities, irrespective of brand; and availability of medicines at patient households', 'availability and price of non-communicable disease medicines']","[{'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C4505065', 'cui_str': 'Non-infectious Diseases'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1869029', 'cui_str': 'Dyslipidaemia (SMQ)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C4505065', 'cui_str': 'Non-infectious Diseases'}]",,0.189302,"The programme did not affect medicine availability at patient households (aOR 0·83, 95% CI 0·44 to 1·57; p=0·569).
","[{'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Rockers', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA. Electronic address: prockers@bu.edu.'}, {'ForeName': 'Richard O', 'Initials': 'RO', 'LastName': 'Laing', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA; School of Public Health, Faculty of Community and Health Sciences, University of Western Cape, Cape Town, South Africa.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Ashigbie', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Monica A', 'Initials': 'MA', 'LastName': 'Onyango', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Carol K', 'Initials': 'CK', 'LastName': 'Mukiira', 'Affiliation': 'Department of Demography and Population Studies, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Veronika J', 'Initials': 'VJ', 'LastName': 'Wirtz', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}]",The Lancet. Global health,['10.1016/S2214-109X(18)30563-1']
1247,31736269,Aqueous humour cytokine changes during a loading phase of intravitreal ranibizumab or dexamethasone implant in diabetic macular oedema.,"PURPOSE


To determine the effect of intravitreal ranibizumab and a dexamethasone implant on aqueous humour cytokine, protein and enzyme levels and to correlate findings to morphologic and functional changes.
METHODS


In a prospective, randomized, controlled, double-blind study, patients with clinically significant diabetic macular oedema (CSME) were randomly allocated to receive either monthly intravitreal injections of ranibizumab (Lucentis, Novartis Pharma) or a single dexamethasone implant (Ozurdex, Pharm-Allergan) at baseline (BL). Aqueous humour samples were collected at BL and weeks 2, 8 and 20.
RESULTS


The study included 18 eyes of 18 patients. In the dexamethasone implant group, soluble intercellular adhesion molecule 1 (sICAM-1) (weeks 2 and 8), CXCL9/monokine induced by gamma interferon (MIG) (weeks 2 and 8), soluble vascular cell adhesion protein 1 (sVCAM-1) (weeks 2 and 8) and monocyte chemo-attractant protein 1 (MCP-1) (week 2) levels were significantly decreased compared with baseline. In the ranibizumab group, placental growth factor (PIGF) (week 2) and vascular endothelial growth factor (VEGF) (week 2 and 8) levels were significantly decreased compared with baseline. No significant changes in central retinal thickness (CRT) or Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) were observed in the Ozurdex group at any time-points. ETDRS scores significantly increased at week 20 (84.88 ± 8.88 letters) compared with baseline (74.78 ± 14.85 letters), and the CRT decreased significantly at week 4 (381.00 ± 114.64 μm) compared with baseline (440 ± 144 μm) in the Lucentis group.
CONCLUSION


The dexamethasone implant affected the aqueous cytokines and proteins MCP-1, sICAM-1, sVCAM-1 and MIG, whereas ranibizumab treatments reduced VEGF and PIGF levels. Morphological changes may diverge from cytokine changes. Results may indicate a rationale for a combination therapy for CSME using both agents, the dexamethasone implant and repeatedly administered ranibizumab injections.",2020,"In the dexamethasone implant group, soluble intercellular adhesion molecule 1 (sICAM-1) (weeks 2 and 8), CXCL9/monokine induced by gamma interferon (MIG) (weeks 2 and 8), soluble vascular cell adhesion protein 1","['diabetic macular oedema', '144\xa0μm) in the Lucentis group', '18 eyes of 18 patients', 'patients with clinically significant diabetic macular oedema (CSME']","['ranibizumab', 'ranibizumab (Lucentis, Novartis Pharma) or a single dexamethasone implant (Ozurdex, Pharm-Allergan) at baseline (BL', 'dexamethasone', 'dexamethasone implant', 'intravitreal ranibizumab']","['aqueous humour cytokine, protein and enzyme levels', 'placental growth factor (PIGF) (week 2) and vascular endothelial growth factor (VEGF', 'aqueous cytokines and proteins MCP-1, sICAM-1, sVCAM-1 and MIG', 'CRT', 'ETDRS scores', 'central retinal thickness (CRT) or Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA', 'soluble vascular cell adhesion protein 1', 'VEGF and PIGF levels', 'soluble intercellular adhesion molecule 1 (sICAM-1']","[{'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C1721374', 'cui_str': 'Lucentis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0730284', 'cui_str': 'Clinically significant macular edema (disorder)'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1721374', 'cui_str': 'Lucentis'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C2702456', 'cui_str': 'Ozurdex'}]","[{'cui': 'C0003662', 'cui_str': 'Intraocular Fluid'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1287349', 'cui_str': 'Finding of enzyme level (finding)'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0007577', 'cui_str': 'Cell Adhesion'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}]",,0.0854803,"In the dexamethasone implant group, soluble intercellular adhesion molecule 1 (sICAM-1) (weeks 2 and 8), CXCL9/monokine induced by gamma interferon (MIG) (weeks 2 and 8), soluble vascular cell adhesion protein 1","[{'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Podkowinski', 'Affiliation': 'Department of Ophthalmology and Optometry, Kepler University Clinic, Linz, Austria.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Orlowski-Wimmer', 'Affiliation': 'Department of Ophthalmology and Optometry, Kepler University Clinic, Linz, Austria.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Zlabinger', 'Affiliation': 'Division of Clinical and Experimental Immunology, Institute of Immunology, Medical University Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Pollreisz', 'Affiliation': 'Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Anna-Sophie', 'Initials': 'AS', 'LastName': 'Mursch-Edlmayr', 'Affiliation': 'Department of Ophthalmology and Optometry, Kepler University Clinic, Linz, Austria.'}, {'ForeName': 'Siegfried', 'Initials': 'S', 'LastName': 'Mariacher', 'Affiliation': 'Department of Ophthalmology and Optometry, Kepler University Clinic, Linz, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ring', 'Affiliation': 'Center for Medical Research, Johannes Kepler University, Linz, Austria.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Bolz', 'Affiliation': 'Department of Ophthalmology and Optometry, Kepler University Clinic, Linz, Austria.'}]",Acta ophthalmologica,['10.1111/aos.14297']
1248,32407460,Cost-Effectiveness of Low-Dose Colchicine after Myocardial Infarction in the Colchicine Cardiovascular Outcomes Trial (COLCOT).,"AIMS


In the randomized, placebo-controlled Colchicine Cardiovascular Outcomes Trial (COLCOT) of 4745 patients enrolled within 30 days after myocardial infarction, low-dose colchicine (0.5 mg once daily) reduced the incidence of the primary composite endpoint of cardiovascular death, resuscitated cardiac arrest, myocardial infarction (MI), stroke, or urgent hospitalization for angina leading to coronary revascularization. To assess the in-trial period and lifetime cost-effectiveness of low-dose colchicine therapy compared to placebo in post-MI patients on standard-of-care therapy.
METHODS AND RESULTS


A multistate Markov model was developed incorporating the primary efficacy and safety results from COLCOT, as well as healthcare costs and utilities from the Canadian healthcare system perspective. All components of the primary outcome, non-cardiovascular deaths, and pneumonia were included as health states in the model as both primary and recurrent events. In the main analysis, a deterministic approach was used to estimate the incremental cost-effectiveness ratio (ICER) for the trial period (24 months) and lifetime (20 years). Over the in-trial period, the addition of colchicine to post-MI standard-of-care treatment decreased the mean overall per patient costs by 47%, from $502 to $265 CAD, and increased the quality adjusted life years (QALYs) from 1.30 to 1.34. The lifetime per patient costs were further reduced (69%) and QALYs increased with colchicine therapy (from 8.82 to 11.68). As a result, both in-trial and lifetime ICERs indicated colchicine therapy was a dominant strategy.
CONCLUSION


Cost-effectiveness analyses indicate that the addition of colchicine to standard-of-care therapy after myocardial infarction is economically dominant and therefore generates cost savings.",2020,The lifetime per patient costs were further reduced (69%) and QALYs increased with colchicine therapy (from 8.82 to 11.68).,"['4745 patients enrolled within 30 days after myocardial infarction, low-dose', 'post-MI patients on standard-of-care therapy']","['colchicine therapy', 'low-dose colchicine therapy', 'Low-Dose Colchicine', 'placebo-controlled Colchicine', 'colchicine', 'placebo']","['lifetime per patient costs', 'mean overall per patient costs', 'cardiovascular death, resuscitated cardiac arrest, myocardial infarction (MI), stroke, or urgent hospitalization for angina leading to coronary revascularization', 'non-cardiovascular deaths, and pneumonia', 'Cost-Effectiveness', 'incremental cost-effectiveness ratio (ICER']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2587207', 'cui_str': 'For resuscitation'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",4745.0,0.209886,The lifetime per patient costs were further reduced (69%) and QALYs increased with colchicine therapy (from 8.82 to 11.68).,"[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Samuel', 'Affiliation': 'From the Montreal Heart Institute, Montreal, Canada.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Tardif', 'Affiliation': 'From the Montreal Heart Institute, Montreal, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Khairy', 'Affiliation': 'From the Montreal Heart Institute, Montreal, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Roubille', 'Affiliation': 'Université de Montpellier, INSERM, CNRS, CHU de Montpellier, France.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Waters', 'Affiliation': 'San Francisco General Hospital, California.'}, {'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'Grégoire', 'Affiliation': 'From the Montreal Heart Institute, Montreal, Canada.'}, {'ForeName': 'Fausto J', 'Initials': 'FJ', 'LastName': 'Pinto', 'Affiliation': 'Santa Maria University Hospital (CHULN); CAML, CCUL, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'From the Montreal Heart Institute, Montreal, Canada.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'From the Montreal Heart Institute, Montreal, Canada.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'University of Glasgow and NHS Glasgow Clinical Research Facility, Glasgow, United Kingdom.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Koenig', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Germany.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Ostadal', 'Affiliation': 'Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Lopez-Sendon', 'Affiliation': 'H La Paz, IdiPaz, UAM, Ciber-CV Madrid, Spain.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Gamra', 'Affiliation': 'Fattouma Bourguiba University Hospital, Monastir, Tunisia.'}, {'ForeName': 'Ghassan S', 'Initials': 'GS', 'LastName': 'Kiwan', 'Affiliation': 'Bellevue Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Dubé', 'Affiliation': 'From the Montreal Heart Institute, Montreal, Canada.'}, {'ForeName': 'Mylène', 'Initials': 'M', 'LastName': 'Provencher', 'Affiliation': 'the Montreal Health Innovations Coordinating Center Montreal, Canada (MHICC:).'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Orfanos', 'Affiliation': 'Institut de Cardiologie et Pneumologie de Québec, Quebec City, Canada.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Blondeau', 'Affiliation': 'the Montreal Health Innovations Coordinating Center Montreal, Canada (MHICC:).'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kouz', 'Affiliation': 'Centre Hospitalier Régional de Lanaudière, Joliette, Canada.'}, {'ForeName': 'Philippe L', 'Initials': 'PL', 'LastName': ""L'Allier"", 'Affiliation': 'From the Montreal Heart Institute, Montreal, Canada.'}, {'ForeName': 'Reda', 'Initials': 'R', 'LastName': 'Ibrahim', 'Affiliation': 'From the Montreal Heart Institute, Montreal, Canada.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Bouabdallaoui', 'Affiliation': 'From the Montreal Heart Institute, Montreal, Canada.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Mitchell', 'Affiliation': 'CHRU de Tours and EA4245 T2I Loire Valley Cardiovascular Collaboration, Tours University, Tours, France.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Guertin', 'Affiliation': 'the Montreal Health Innovations Coordinating Center Montreal, Canada (MHICC:).'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Lelorier', 'Affiliation': 'From the Montreal Heart Institute, Montreal, Canada.'}]",European heart journal. Quality of care & clinical outcomes,['10.1093/ehjqcco/qcaa045']
1249,32407583,Proprioceptive neuromuscular facilitation Improves Pain and Descending Mechanics among Elderly with Knee Osteoarthritis.,"PURPOSE


Knee osteoarthritis (KOA) is a common disease that causes pain and limits functionality in the elderly during daily activities, especially during stair descent. Proprioceptive neuromuscular facilitation (PNF) practices promote multiple-plane joint movements, which relieve pain and increase joint range of motion (ROM). This study aims to examine the effects of a 12-week PNF intervention on pain relief, passive and active joint ROM, external knee adduction moment (KAM) and hip adduction moment (HAM) in the elderly with KOA during stair descent.
MATERIALS AND METHODS


Seventy-six elderly who were diagnosed with KOA were assessed for eligibility and, 36 of them met the inclusive criteria, were randomly divided into two groups: the twelve-week PNF intervention group and the control group. Pain score was measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC). Passive joint ROM was measured using a goniometer. Active joint ROM, KAM, and HAM during stair descent were measured using a motion analysis system with a force platform. All the data were recorded at weeks 0, 6, and 12.
RESULTS


Compared to the control group, the PNF group showed a decreased pain score; increased passive hip, knee, and ankle ROM; a decreased minimum knee flexion angle, and increased HAM during stair descent.
PERSPECTIVE


PNF intervention is a successful method to relieve symptoms of KOA. It relieves pain without increasing KAM, enhances passive ROM, increases active knee flexion ROM, and increases HAM during stair descent in the elderly with KOA.",2020,"Compared to the control group, the PNF group showed a decreased pain score; increased passive hip, knee, and ankle ROM; a decreased minimum knee flexion angle, and increased HAM during stair descent.
","['Seventy-six elderly who were diagnosed with KOA were assessed for eligibility and, 36 of them met the inclusive criteria', 'elderly with KOA during stair descent', 'Elderly with Knee Osteoarthritis']","['Proprioceptive neuromuscular facilitation (PNF) practices', 'Proprioceptive neuromuscular facilitation', 'PNF', 'PNF intervention']","['minimum knee flexion angle, and increased HAM during stair descent', 'Pain score', 'Passive joint ROM', 'pain score; increased passive hip, knee, and ankle ROM', 'HAM', 'pain and increase joint range of motion (ROM', 'Active joint ROM, KAM, and HAM during stair descent', 'Western Ontario and McMaster Universities Arthritis Index (WOMAC', 'pain relief, passive and active joint ROM, external knee adduction moment (KAM) and hip adduction moment (HAM', 'active knee flexion ROM']","[{'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205386', 'cui_str': 'Descending'}]","[{'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0576183', 'cui_str': 'Ankle joint - range of movement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205101', 'cui_str': 'External'}]",76.0,0.023522,"Compared to the control group, the PNF group showed a decreased pain score; increased passive hip, knee, and ankle ROM; a decreased minimum knee flexion angle, and increased HAM during stair descent.
","[{'ForeName': 'Qipeng', 'Initials': 'Q', 'LastName': 'Song', 'Affiliation': 'Shandong Sport University, Jinan, China, 250102.'}, {'ForeName': 'Peixin', 'Initials': 'P', 'LastName': 'Shen', 'Affiliation': 'Beijing Sport University, Beijing, China, 100091.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Mao', 'Affiliation': 'The University of North Carolina at Chapel Hill, Chapel Hill, USA, 27510.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Shandong Institute of Sport Science, Jinan, China, 250102.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Shandong Institute of Sport Science, Jinan, China, 250102.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Georgia Southern University, Statesboro, USA, 30460.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13709']
1250,30801523,"Phase I/II Trial of Liver-derived Mesenchymal Stem Cells in Pediatric Liver-based Metabolic Disorders: A Prospective, Open Label, Multicenter, Partially Randomized, Safety Study of One Cycle of Heterologous Human Adult Liver-derived Progenitor Cells (HepaStem) in Urea Cycle Disorders and Crigler-Najjar Syndrome Patients.","BACKGROUND


Regenerative medicine using stem cell technology is an emerging field that is currently tested for inborn and acquired liver diseases.
OBJECTIVE


This phase I/II prospective, open label, multicenter, randomized trial aimed primarily at evaluating the safety of Heterologous Human Adult Liver-derived Progenitor Cells (HepaStem) in pediatric patients with urea cycle disorders (UCDs) or Crigler-Najjar (CN) syndrome 6 months posttransplantation. The secondary objective included the assessment of safety up to 12 months postinfusion and of preliminary efficacy.
METHODS


Fourteen patients with UCDs and 6 with CN syndrome were divided into 3 cohorts by body weight and intraportally infused with 3 doses of HepaStem. Clinical status, portal vein hemodynamics, morphology of the liver, de novo detection of circulating anti-human leukocyte antigen antibodies, and clinically significant adverse events (AEs) and serious adverse events to infusion were evaluated by using an intent-to-treat analysis.
RESULTS


The overall safety of HepaStem was confirmed. For the entire study period, patient-month incidence rate was 1.76 for the AEs and 0.21 for the serious adverse events, of which 38% occurred within 1 month postinfusion. There was a trend of higher events in UCD as compared with CN patients. Segmental left portal vein thrombosis occurred in 1 patient and intraluminal local transient thrombus in a second patient. The other AEs were in line with expectations for catheter placement, cell infusion, concomitant medications, age, and underlying diseases.
CONCLUSIONS


This study led to European clinical trial authorization for a phase II study in a homogeneous patient cohort, with repeated infusions and intermediate doses.",2019,"For the entire study period, patient-month incidence rate was 1.76 for the AEs and 0.21 for the SAEs, of which 38% occurred within one month post-infusion.","['Fourteen patients with UCDs and 6 with CN syndrome', 'Pediatric Liver Based Metabolic Disorders', 'Urea Cycle Disorders and Crigler-Najjar Syndrome patients', 'homogeneous patient cohort, with repeated infusions and intermediate doses', 'pediatric patients with urea cycle disorders (UCDs) or Crigler-Najjar (CN) syndrome 6 months post-transplantation']","['Heterologous Human Adult Liver-Derived Progenitor Cells (HepaStem®', 'Liver Derived Mesenchymal Stem Cells', 'Heterologous Human Adult Liver-derived Progenitor Cells (HepaStem']","['patient-month incidence rate', 'overall safety of HepaStem', 'Segmental left portal vein thrombosis']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025517', 'cui_str': 'Thesaurismosis'}, {'cui': 'C0154246', 'cui_str': 'Urea Cycle Disorders'}, {'cui': 'C0010324', 'cui_str': 'Familial Nonhemolytic Unconjugated Hyperbilirubinemia'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0439860', 'cui_str': 'Heterologous (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal Stem Cells'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205122', 'cui_str': 'Segmental (qualifier value)'}, {'cui': 'C0933785', 'cui_str': 'Left portal vein'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}]",14.0,0.0438568,"For the entire study period, patient-month incidence rate was 1.76 for the AEs and 0.21 for the SAEs, of which 38% occurred within one month post-infusion.","[{'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Smets', 'Affiliation': 'Department of Paediatrics, Paediatric Gastroenterology and Hepatology Unit, Cliniques Universitaires St Luc, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Dries', 'Initials': 'D', 'LastName': 'Dobbelaere', 'Affiliation': ""Medical Reference Center for Inherited Metabolic Diseases, University Children's Hospital Jeanne de Flandre and RADEME Research Team for Rare Metabolic and Developmental Diseases, EA 7364, University Lille 2, CHRU Lille, Lille, France.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'McKiernan', 'Affiliation': ""Liver Unit, Birmingham Children's Hospital, Birmingham, United Kingdom.""}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Dionisi-Vici', 'Affiliation': 'Department of Hepatology, Gastroenterology and Nutrition, Ospedale Pediatrico Bambino Gesù di Roma, Roma, Italy.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Broué', 'Affiliation': 'Hépatologie pédiatrique et maladies héréditaires du métabolisme, Centre de compétences maladies héréditaires du métabolisme, Hôpital des enfants, CHU Toulouse, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Jacquemin', 'Affiliation': 'Pediatric Hepatology and Liver Transplantation Unit, Reference Centre for Rare Liver Diseases, CHU Bicêtre, Assistance Publique, Hôpitaux de Paris, DHU Hepatinov, INSERM 1174, University Paris Sud, Paris, France.'}, {'ForeName': 'Ana Isabel', 'Initials': 'AI', 'LastName': 'Lopes', 'Affiliation': 'Department of Pediatrics, Gastroenterology Unit, Medical Faculty of Lisbon, University Hospital Santa Maria, Lisbon, Portugal.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Gonçalves', 'Affiliation': 'Hospital Pediátrico de Coimbra, Centro Hospitalar da Universidade de Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Mandel', 'Affiliation': ""Department of Pediatrics, Metabolic Unit, Rambam Medical Center, Meyer Children's Hospital, Haifa, Israel.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Pawlowska', 'Affiliation': ""Department of Gastroenterology, Hepatology and Nutritional Disorders, The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Kamińska', 'Affiliation': ""Department of Gastroenterology, Hepatology and Nutritional Disorders, The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Shteyer', 'Affiliation': 'Department of Pediatrics, Hadassah Ein-Kerem Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Giuliano', 'Initials': 'G', 'LastName': 'Torre', 'Affiliation': 'Department of Hepatology, Gastroenterology and Nutrition, Ospedale Pediatrico Bambino Gesù di Roma, Roma, Italy.'}, {'ForeName': 'Riki', 'Initials': 'R', 'LastName': 'Shapiro', 'Affiliation': ""Liver Transplantation Unit, Institute of Gastroenterology, Schneider Children's Medical Center of Israel, Petach Tikva, Israel.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Eyskens', 'Affiliation': 'Paediatric department, Universitair Ziekenhuis Antwerpen, Edegem, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Clapuyt', 'Affiliation': 'Department of Radiology, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gissen', 'Affiliation': 'GOSH UCL Biomedical Center, UCL Great Ormond Street Institute of Child Health, London, United Kingdom.'}, {'ForeName': 'Danièle', 'Initials': 'D', 'LastName': 'Pariente', 'Affiliation': 'Department of Radiology, CHU Bicêtre, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Grunewald', 'Affiliation': 'Centre for Inborn Errors of Metabolism, Great Ormond Street Hospital and Institute of Child Health, UCL, London, United Kingdom.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Yudkoff', 'Affiliation': ""Mass Spectroscopy Center, The Children's Hospital of Philadelphia, Philadelphia, USA.""}, {'ForeName': 'Maria Mercedes', 'Initials': 'MM', 'LastName': 'Binda', 'Affiliation': 'Promethera Biosciences, Mont-Saint-Guibert, Belgium.'}, {'ForeName': 'Mustapha', 'Initials': 'M', 'LastName': 'Najimi', 'Affiliation': 'Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Belmonte', 'Affiliation': 'Promethera Biosciences, Mont-Saint-Guibert, Belgium.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'de Vos', 'Affiliation': 'Promethera Biosciences, Mont-Saint-Guibert, Belgium.'}, {'ForeName': 'Joelle', 'Initials': 'J', 'LastName': 'Thonnard', 'Affiliation': 'Promethera Biosciences, Mont-Saint-Guibert, Belgium.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Sokal', 'Affiliation': 'Department of Paediatrics, Paediatric Gastroenterology and Hepatology Unit, Cliniques Universitaires St Luc, Université Catholique de Louvain, Brussels, Belgium.'}]",Transplantation,['10.1097/TP.0000000000002605']
1251,30801548,Safety of Everolimus With Reduced Calcineurin Inhibitor Exposure in De Novo Kidney Transplants: An Analysis From the Randomized TRANSFORM Study.,"BACKGROUND


The safety profiles of standard therapy versus everolimus with reduced-exposure calcineurin inhibitor (CNI) therapy using contemporary protocols in de novo kidney transplant recipients have not been compared in detail.
METHODS


TRANSFORM was a randomized, international trial in which de novo kidney transplant patients were randomized to everolimus with reduced-exposure CNI (N = 1014) or mycophenolic acid (MPA) with standard-exposure CNI (N = 1012), both with induction and corticosteroids.
RESULTS


Within the safety population (everolimus 1014, MPA 1012), adverse events with a suspected relation to study drug occurred in 62.9% versus 59.2% of patients given everolimus or MPA, respectively (P = 0.085). Hyperlipidemia, interstitial lung disease, peripheral edema, proteinuria, stomatitis/mouth ulceration, thrombocytopenia, and wound healing complications were more frequent with everolimus, whereas diarrhea, nausea, vomiting, leukopenia, tremor, and insomnia were more frequent in the MPA group. The incidence of viral infections (17.2% versus 29.2%; P < 0.001), cytomegalovirus (CMV) infections (8.1% versus 20.1%; P < 0.001), CMV syndrome (13.6% versus 23.0%, P = 0.044), and BK virus (BKV) infections (4.3% versus 8.0%, P < 0.001) were less frequent with everolimus. CMV infection was less common with everolimus versus MPA after adjusting for prophylaxis therapy in the D+/R- subgroup (P < 0.001). Study drug was discontinued more frequently due to rejection or impaired healing with everolimus, and more often due to BKV infection or BKV nephropathy with MPA.
CONCLUSIONS


De novo everolimus with reduced-exposure CNI yielded a comparable incidence, though a distinctly different pattern, of adverse events versus current standard of care. Both regimens are safe and effective, yet their distinct profiles may enable tailoring for individual kidney transplant recipients.",2019,"The incidence of viral infections (17.2% versus 29.2%; p<0.001), CMV infections (8.1% versus 20.1%; p<0.001), CMV syndrome (13.6% versus 23.0%, p=0.044) and BKV infections (4.3% versus 8.0%, p<0.001) were less frequent with everolimus.","['de novo kidney transplant patients', 'individual kidney transplant recipients', 'de novo kidney transplant recipients', 'De Novo Kidney Transplants']","['everolimus with reduced-exposure CNI (N=1014) or mycophenolic acid (MPA) with standard-exposure CNI (N=1012), both with induction and corticosteroids', 'Everolimus', 'standard therapy versus everolimus with reduced-exposure calcineurin inhibitor (CNI) therapy']","['CMV syndrome', 'incidence of viral infections', 'diarrhea, nausea, vomiting, leukopenia, tremor and insomnia', 'CMV infections', 'adverse events', 'Hyperlipidemia, interstitial lung disease, peripheral edema, proteinuria, stomatitis/mouth ulceration, thrombocytopenia and wound healing complications', 'BKV infections', 'CMV infection']","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}]","[{'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0042769', 'cui_str': 'Viral Infections'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0010823', 'cui_str': 'Salivary Gland Virus Disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C1869044', 'cui_str': 'Interstitial lung disease (SMQ)'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema (morphologic abnormality)'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0149745', 'cui_str': 'Mouth Ulcer'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0043187', 'cui_str': 'Wind'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",,0.0213168,"The incidence of viral infections (17.2% versus 29.2%; p<0.001), CMV infections (8.1% versus 20.1%; p<0.001), CMV syndrome (13.6% versus 23.0%, p=0.044) and BKV infections (4.3% versus 8.0%, p<0.001) were less frequent with everolimus.","[{'ForeName': 'Helio', 'Initials': 'H', 'LastName': 'Tedesco-Silva', 'Affiliation': 'Division of Nephrology, Hospital do Rim, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Pascual', 'Affiliation': 'Department of Nephrology, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Ondrej', 'Initials': 'O', 'LastName': 'Viklicky', 'Affiliation': 'Department of Nephrology, Transplant Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Nikolina', 'Initials': 'N', 'LastName': 'Basic-Jukic', 'Affiliation': 'Department of Nephrology, Arterial Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, School of Medicine, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Cassuto', 'Affiliation': 'Department of Nephrology and Renal Transplantation, Hôpital Pasteur, Nice, France.'}, {'ForeName': 'Dean Y', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Division of Transplant and Hepatobiliary Surgery, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Cruzado', 'Affiliation': 'Department of Nephrology, Hospital Universitari de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Sommerer', 'Affiliation': 'Department of Nephrology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Adel Bakr', 'Affiliation': 'Mansoura Urology and Nephrology Center, Mansoura, Egypt.'}, {'ForeName': 'Valter D', 'Initials': 'VD', 'LastName': 'Garcia', 'Affiliation': 'Department of Renal Transplantation, Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Huynh-Do', 'Initials': 'HD', 'LastName': 'Uyen', 'Affiliation': 'Department of Nephrology and Hypertension, Inselspital Bern, Bern, Switzerland.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Russ', 'Affiliation': 'Central and Northern Adelaide Renal and Transplantation Services, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Myoung', 'Initials': 'M', 'LastName': 'Soo Kim', 'Affiliation': 'Department of Transplantation Surgery, Severance Hospital Yonsei University Health System, Seoul, Republic of Korea.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Kuypers', 'Affiliation': 'Department of Nephrology and Renal Transplantation, Gasthuisberg University Hospital, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Buchler', 'Affiliation': 'Department of Nephrology and Renal Transplantation, CHRU de Tours, Hôpital Bretonneau, Tours, France.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Citterio', 'Affiliation': 'Policlinico Foundation, A Gemelli University, IRCCS, Catholic University of the Sacred Heart, Rome, Italy.'}, {'ForeName': 'Maria Pilar', 'Initials': 'MP', 'LastName': 'Hernandez Gutierrez', 'Affiliation': 'Research and Development, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bernhardt', 'Affiliation': 'Research and Development, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Chadban', 'Affiliation': 'Department of Renal Medicine, Royal Prince Alfred Hospital, University of Sydney, Sydney, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Transplantation,['10.1097/TP.0000000000002626']
1252,30795958,Safety and efficacy of stopping tenofovir disoproxil fumarate in patients with chronic hepatitis B following at least 8 years of therapy: a prespecified follow-up analysis of two randomised trials.,"BACKGROUND


Effective and well tolerated nucleos(t)ide analogue treatment exists for patients with chronic hepatitis B, although treatment is generally anticipated to be life-long, with concomitant costs and treatment-related side-effects. We aimed to characterise the outcomes of patients with persistent viral suppression who discontinued nucleotide analogue use after extended treatment.
METHODS


The primary objective of this prespecified analysis was to evaluate the safety of stopping long-term tenofovir disoproxil fumarate therapy in patients enrolled in two (completed) randomised controlled studies, GS-US-174-0102 (ClinicalTrials.gov, number NCT00117676) and GS-US-174-0103 (ClinicalTrials.gov, number NCT00116805). In those studies, patients who had completed 8 years or more of nucleotide analogue treatment, were hepatitis B surface antigen (HBsAg)-positive with hepatitis B virus (HBV) DNA concentration of less than 29 IU/mL, and were unwilling or unable to continue therapy were required by protocol to enter a 24-week treatment-free follow-up (TFFU) phase. We present data for patients in the TFFU phase who were assessed at baseline and monitored every 4 weeks for changes in qualitative serum HBsAg, HBV DNA, and alanine aminotransferase (ALT) concentrations in addition to standard safety assessments.
FINDINGS


Of 124 patients who entered the TFFU phase, 54 (44%) patients did not complete 24 weeks of follow-up (median 12 weeks; IQR 0-20). Overall, 32 (26%) patients reported an adverse event. Serious adverse events occurred in five (4%) patients, including elevated ALT concentrations in two patients, hepatic flare in two patients, and increased lipase in one patient. 38 (31%) of patients had grade 3 or higher laboratory abnormalities, the majority of which were ALT elevations (36 patients). Of the 106 hepatitis B e antigen (HBeAg)-negative patients who entered the TFFU phase, 63 (59%) were followed for 24 weeks. HBsAg loss was observed in five (5%) of the 106 HBeAg-negative patients who entered the TFFU phase, and 37 (35%) had both HBV DNA concentrations of less than 2000 IU/mL and ALT concentrations less than the ULN at TFFU week 24. 18 HBeAg-positive patients entered the TFFU phase, of whom seven (39%) were followed up for 24 weeks. Of these seven patients, none had HBsAg loss or HBV DNA of less than 2000 IU/mL and one (14%) had an ALT less than the ULN at week 24.
INTERPRETATION


Within 24 weeks of stopping 8 years or more of nucleotide analogue therapy almost a third of patients experienced a grade 3 or higher laboratory abnormality. Although few patients achieved HBsAg loss, a subgroup of HBeAg-negative patients can achieve a low-replicative state within a short duration of follow-up.
FUNDING


Gilead Sciences, Inc.",2019,"Serious adverse events occurred in five (4%) patients, including elevated ALT concentrations in two patients, hepatic flare in two patients, and increased lipase in one patient.","['patients with chronic hepatitis B following at least 8 years of therapy', '124 patients who entered the TFFU phase, 54 (44', 'patients with persistent viral suppression who discontinued nucleotide analogue use after extended treatment', '106 hepatitis B e antigen (HBeAg)-negative patients who entered the TFFU phase, 63 (59%) were followed for 24 weeks', 'patients enrolled in two (completed', 'patients with chronic hepatitis B']","['stopping tenofovir disoproxil fumarate', 'nucleotide analogue therapy', 'stopping long-term tenofovir disoproxil fumarate therapy']","['qualitative serum HBsAg, HBV DNA, and alanine aminotransferase (ALT) concentrations', 'hepatitis B surface antigen (HBsAg)-positive with hepatitis B virus (HBV) DNA concentration', 'HBsAg loss or HBV DNA', 'HBV DNA concentrations', 'hepatic flare', 'HBsAg loss', 'elevated ALT concentrations', 'adverse event', 'Serious adverse events', 'Safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0028630', 'cui_str': 'Nucleotides'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0948827', 'cui_str': 'Hepatitis B e antigen negative'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0028630', 'cui_str': 'Nucleotides'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement (procedure)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0149709', 'cui_str': 'HBsAg positive'}, {'cui': 'C0369332', 'cui_str': 'Hepatitis B virus DNA'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.185683,"Serious adverse events occurred in five (4%) patients, including elevated ALT concentrations in two patients, hepatic flare in two patients, and increased lipase in one patient.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Buti', 'Affiliation': ""Liver Unit, Hospital Universitari Vall d'Hebron and CIBEREHD del Instituto Carlos III, Barcelona, Spain. Electronic address: mbuti@vhebron.net.""}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Wong', 'Affiliation': 'Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Gane', 'Affiliation': 'New Zealand Liver Transplant Unit, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Flisiak', 'Affiliation': 'Department of Infectious Diseases and Hepatology, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Manns', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany; Helmholtz Center for Infection Research, Braunschweig, Hannover, Germany.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Kaita', 'Affiliation': 'Viral Hepatitis Investigative Unit, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Harry L A', 'Initials': 'HLA', 'LastName': 'Janssen', 'Affiliation': 'Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Marjoleine', 'Initials': 'M', 'LastName': 'Op den Brouw', 'Affiliation': 'Gilead Sciences Europe, Uxbridge, UK.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Jump', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Kitrinos', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Crans', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Flaherty', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Gaggar', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Marcellin', 'Affiliation': 'Viral Hepatitis Research Unit, Hôpital Beaujon, Clichy, France.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30015-9']
1253,32407535,Comparative Reactogenicity of Enhanced Influenza Vaccines in Older Adults.,"BACKGROUND


We analysed data from a randomized controlled trial on the reactogenicity of three enhanced influenza vaccines compared to standard-dose inactivated influenza vaccine.
METHODS


We enrolled community-dwelling older adults in Hong Kong, and randomly allocated them to receive 2017/18 northern hemisphere formulations of: standard-dose vaccine (FluQuadri, Sanofi Pasteur); MF59-adjuvanted vaccine (FLUAD, Seqirus); high-dose vaccine (Fluzone High Dose, Sanofi Pasteur); or recombinant-hemagglutinin vaccine (Flublok, Sanofi Pasteur). Local and systemic reactions were evaluated at Days 1, 3, 7 and 14 after vaccination.
RESULTS


Reported reactions were generally mild and short-lived. Systemic reactions occurred in similar proportions of participants by vaccine. Some local reactions were slightly more frequently reported among recipients of the MF59-adjuvanted vaccine and the high-dose vaccine compared to standard dose recipients. Participants reporting feverishness one day after vaccination had mean-fold-rises in post-vaccination hemagglutination inhibition titers that were 1.85-fold higher (95% CI: 1.01, 3.38) for A(H1N1) compared to those who did not report feverishness.
CONCLUSIONS


Some acute local reactions were more frequent following vaccination with MF59-adjuvanted and high-dose influenza vaccines compared to standard-dose inactivated influenza vaccine, while systemic symptoms occurred at similar frequencies in all groups. The association between feverishness and immunogenicity should be further investigated in a larger population.",2020,"Participants reporting feverishness one day after vaccination had mean-fold-rises in post-vaccination hemagglutination inhibition titers that were 1.85-fold higher (95% CI: 1.01, 3.38) for A(H1N1) compared to those who did not report feverishness.
","['enrolled community-dwelling older adults in Hong Kong', 'Older Adults']","['standard-dose inactivated influenza vaccine', 'influenza vaccines', 'Enhanced\xa0Influenza\xa0Vaccines', '2017/18 northern hemisphere formulations of: standard-dose vaccine (FluQuadri, Sanofi Pasteur); MF59-adjuvanted vaccine (FLUAD, Seqirus); high-dose vaccine (Fluzone High Dose, Sanofi Pasteur); or recombinant-hemagglutinin vaccine (Flublok, Sanofi Pasteur']","['local reactions', 'acute local reactions', 'Systemic reactions', 'Local and systemic reactions', 'mean-fold-rises in post-vaccination hemagglutination inhibition titers', 'systemic symptoms']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0289787', 'cui_str': 'MF59 oil emulsion'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C2740348', 'cui_str': 'Fluzone High-Dose'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C2353376', 'cui_str': 'FluBlok'}]","[{'cui': 'C0853813', 'cui_str': 'Local reaction'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.154772,"Participants reporting feverishness one day after vaccination had mean-fold-rises in post-vaccination hemagglutination inhibition titers that were 1.85-fold higher (95% CI: 1.01, 3.38) for A(H1N1) compared to those who did not report feverishness.
","[{'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Cowling', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Thompson', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Tiffany W Y', 'Initials': 'TWY', 'LastName': 'Ng', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Vicky J', 'Initials': 'VJ', 'LastName': 'Fang', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Ranawaka A P M', 'Initials': 'RAPM', 'LastName': 'Perera', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Nancy H L', 'Initials': 'NHL', 'LastName': 'Leung', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Yuyun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Hau Chi', 'Initials': 'HC', 'LastName': 'So', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Dennis K M', 'Initials': 'DKM', 'LastName': 'Ip', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'A Danielle', 'Initials': 'AD', 'LastName': 'Iuliano', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa255']
1254,26689935,Effect of Anodal and Cathodal Transcranial Direct Current Stimulation on DLPFC on Modulation of Inhibitory Control in ADHD.,"OBJECTIVE


The purpose of this study was to improve the inhibitory control functions through transcranial direct current stimulation (tDCS) in adolescents with ADHD symptoms.
METHOD


Twenty high school students with ADHD symptoms participated in this single-blinded, crossover, sham-controlled study. All the participants were tested during the application of Stroop and Go/No-Go tasks that is used to measure inhibitory control, using 1.5 mA of tDCS for 15 min over the left dorsolateral prefrontal cortex (DLPFC).
RESULTS


Anodal stimulation on left DLPFC had no effect on interference inhibition during the Stroop task and increased the proportion of correct responses in the ""Go stage"" of the Go/No-Go test compared with sham condition. Cathodal stimulation on the left DLPFC increased the inhibition accuracy in the inhibition stage during Go/No-Go task in comparison with sham.
CONCLUSION


tDCS over the left DLPFC of adolescents who suffer from ADHD symptoms can improve inhibitory control in prepotent response inhibition.",2019,"Cathodal stimulation on the left DLPFC increased the inhibition accuracy in the inhibition stage during Go/No-Go task in comparison with sham.
","['Twenty high school students with ADHD symptoms participated', 'adolescents with ADHD symptoms']","['Anodal and Cathodal Transcranial Direct Current Stimulation', 'tDCS', 'transcranial direct current stimulation (tDCS']","['proportion of correct responses', 'interference inhibition']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]",20.0,0.0282462,"Cathodal stimulation on the left DLPFC increased the inhibition accuracy in the inhibition stage during Go/No-Go task in comparison with sham.
","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Soltaninejad', 'Affiliation': '1 Shahid Beheshti University, Tehran, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Nejati', 'Affiliation': '1 Shahid Beheshti University, Tehran, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Ekhtiari', 'Affiliation': '2 Tehran University of Medical Sciences, Iran.'}]",Journal of attention disorders,['10.1177/1087054715618792']
1255,30784637,"Integrating an early childhood development programme into Bangladeshi primary health-care services: an open-label, cluster-randomised controlled trial.","BACKGROUND


Poor development in young children in developing countries is a major problem. Child development experts are calling for interventions that aim to improve child development to be integrated into health services, but there are few robust evaluations of such programmes. Previous small Bangladeshi trials that used individual play sessions with mothers and their children (at home or in clinics), which were predominantly run by employed women, found moderate improvements on child development. We aimed to integrate an early childhood development programme into government clinics that provide primary health care and to evaluate the effects of this intervention on child cognition, language, and motor development, growth, and behaviour in a subsample of the children.
METHODS


In this open-label cluster-randomised controlled trial, we recruited individuals from community clinics in Narsingdi district, Bangladesh. These clinics were randomly selected from a larger sample of eligible clinics, and they were assigned (1:1) to either deliver an intervention of 25 sessions, in which mothers of eligible children were shown how to support their child's development through play and interactions, or to deliver no intervention (control group). Participants were underweight children, defined as a weight-for-age Z score of -2 SDs of the WHO standard, who were aged 5-24 months and who lived near the clinic (defined as a walk of less than 30 min). Government health workers ran these sessions at the clinics as part of their routine work, and mothers and children attended fortnightly in pairs (instead of individual weekly home visits that were specified in the original programme). A subsample of children from each clinic was randomly selected for impact evaluation, and these children were assessed on the Bayley Scales of Infant and Toddler Development for their cognitive, language, and motor performance and for their behaviour with Wolke's ratings, before and after implementation of the intervention. The primary outcomes were the performance of this evaluation subsample on the Bayley and Wolke scales and their anthropometric measurements (weight, length or height, and head circumference) after 1 year of the intervention. This study is registered with ClinicalTrials.gov, number NCT02208531.
FINDINGS


Between Nov 29, 2014, and April 30, 2015, 12 054 children in 90 clinics were screened, and between six and 25 underweight children were enrolled from each clinic. From the 2423 (20%) underweight children, we excluded 656 (27%) children who lived more than 30-min walking distance from the community clinics, and 30 (1%) children whose mothers did not consent to participate. We therefore enrolled 1737 (72%) children from these 90 clinics. After randomisation, the control group clinics included 878 (51%) children (who all received no intervention) and the intervention group clinics included 859 (49%) children (who all received the child development programme sessions). Eight children from each clinic (360 [41%] children from the control group clinics and 358 [42%] children from the intervention group clinics) were randomly selected for inclusion in the evaluation subsample. Between Feb 24, 2016, and Sept 7, 2016, 344 (96%) children in control group clinics and 343 (96%) children in intervention group clinics were assessed for the primary outcome. 16 (5%) children in the control group clinics and 15 (4%) children in the intervention group clinics did not provide all data and were not included in final analyses. An intention-to-treat analysis showed that the intervention significantly improved children's cognition (effect size 1·3 SDs, 95% CI 1·1 to 1·5; p=0·006), language (1·1 SDs, 0·9 to 1·2; p=0·01), and motor composite scores (1·2 SDs, 1·0 to 1·3; p=0·006) and behaviour ratings (ranging from 0·7 SDs, 0·5 to 0·9; p=0·02; to 1·1 SDs, 1·0 to 1·2; p=0·007), but the intervention had no significant effect on growth (p values ranged from 0·05 to 0·74). Three (1%) children in the intervention group died, but their deaths were not related to the intervention.
INTERPRETATION


The extent and range of benefits of our intervention are encouraging. Health workers ran most of the sessions effectively and attendance was good, which is promising for scale-up of the intervention model. However, researchers trained and supervised the health workers, and the next step will be to determine whether the Bangladeshi ministry of health can perform these tasks. In future programmes, more attention needs to be paid to the nutrition of the children.
FUNDING


Grand Challenges Canada (Saving Brains).",2019,"An intention-to-treat analysis showed that the intervention significantly improved children's cognition (effect size 1·3 SDs, 95% CI 1·1 to 1·5; p=0·006), language (1·1 SDs, 0·9 to 1·2; p=0·01), and motor composite scores (1·2 SDs, 1·0 to 1·3; p=0·006) and behaviour ratings (ranging from 0·7 SDs, 0·5","['Between Nov 29, 2014, and April 30, 2015', 'mothers and their children (at home or in clinics', 'young children', 'From the 2423 (20%) underweight children, we excluded 656 (27%) children who lived more than 30-min walking distance from the community clinics, and 30 (1%) children whose mothers did not consent to participate', 'control group clinics included 878 (51%) children (who all received no intervention) and the intervention group clinics included 859 (49%) children (who all received the child development programme sessions', 'Eight children from each clinic (360 [41%] children from the control group clinics and 358 [42%] children from the intervention group clinics', 'recruited individuals from community clinics in Narsingdi district, Bangladesh', 'Participants were underweight children, defined as a weight-for-age Z score of -2 SDs of the WHO standard, who were aged 5-24 months and who lived near the clinic (defined as a walk of less than 30 min', 'enrolled 1737 (72%) children from these 90 clinics', ' 12\u2008054 children in 90 clinics were screened, and between six and 25 underweight children were enrolled from each clinic']","['early childhood development programme into Bangladeshi primary health-care services', ""support their child's development through play and interactions, or to deliver no intervention (control group""]","[""Bayley Scales of Infant and Toddler Development for their cognitive, language, and motor performance and for their behaviour with Wolke's ratings"", 'motor composite scores', 'behaviour ratings', 'performance of this evaluation subsample on the Bayley and Wolke scales and their anthropometric measurements (weight, length or height, and head circumference', ""children's cognition"", 'child cognition, language, and motor development, growth, and behaviour']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0205172', 'cui_str': 'More (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0587907', 'cui_str': 'Community clinic (environment)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0332273', 'cui_str': 'Through (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0222045'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",8.0,0.0456209,"An intention-to-treat analysis showed that the intervention significantly improved children's cognition (effect size 1·3 SDs, 95% CI 1·1 to 1·5; p=0·006), language (1·1 SDs, 0·9 to 1·2; p=0·01), and motor composite scores (1·2 SDs, 1·0 to 1·3; p=0·006) and behaviour ratings (ranging from 0·7 SDs, 0·5","[{'ForeName': 'Jena D', 'Initials': 'JD', 'LastName': 'Hamadani', 'Affiliation': 'Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh. Electronic address: jena@icddrb.org.'}, {'ForeName': 'Syeda F', 'Initials': 'SF', 'LastName': 'Mehrin', 'Affiliation': 'Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Fahmida', 'Initials': 'F', 'LastName': 'Tofail', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Mohammad I', 'Initials': 'MI', 'LastName': 'Hasan', 'Affiliation': 'Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Syed N', 'Initials': 'SN', 'LastName': 'Huda', 'Affiliation': 'Toronto, ON, Canada.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Baker-Henningham', 'Affiliation': 'School of Psychology, Bangor University, Bangor, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Ridout', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Grantham-McGregor', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, London, UK.'}]",The Lancet. Global health,['10.1016/S2214-109X(18)30535-7']
1256,30784638,Household contact investigation for the detection of tuberculosis in Vietnam: economic evaluation of a cluster-randomised trial.,"BACKGROUND


Active case finding is recommended as an important strategy to control tuberculosis, particularly in low-income and middle-income countries with a high prevalence of the disease. However, the costs and cost-effectiveness of active case finding are unclear due to the absence of evidence from randomised trials. We assessed the costs and cost-effectiveness of an active case finding strategy in Vietnam, where there is a high prevalence of tuberculosis.
METHODS


We conducted an economic evaluation alongside the Active Case Finding in Tuberculosis (ACT2) trial-a pragmatic cluster-randomised controlled trial in 70 districts across eight provinces of Vietnam. Patients aged 15 years and older with smear-positive pulmonary tuberculosis were recruited to the trial if they lived with one or more other household members. Household contacts were verbally invited to the clinic by the index patient with tuberculosis. ACT2 compared a combination of active and passive case finding with usual care (passive case finding) of household contacts of patients with tuberculosis from a health system perspective. Clustering occurred at the district and household level. Districts were the unit of randomisation, and we used minimisation to ensure balance of intervention and control districts within each province. In the intervention group, participants were invited to attend screening at baseline, 6 months, 12 months, and 24 months. We determined health-care costs with a standardised national costing survey and reported results in 2017 $US. The primary outcome of our study was disability-adjusted life years (DALYs) averted over a 24-month period. ACT2 was registered prospectively with the Australian and New Zealand Clinical Trials Registry, number ACTRN126.100.00600044.
FINDINGS


Between Aug 11, 2010, and Aug 11, 2015, 10 964 index patients and 25 707 household contacts completed the ACT2 study. There were 10 069 household contacts in the intervention group and 15 638 household contacts in the control group. The incremental cost-effectiveness ratio per DALY averted was $544 (330-1375).
INTERPRETATION


Active case finding was shown to be highly cost-effective in a setting with a high prevalence of tuberculosis. Investment in the wide-scale implementation of this programme in Vietnam should be strongly supported.
FUNDING


Australian National Health and Medical Research Council.",2019,"The incremental cost-effectiveness ratio per DALY averted was $544 (330-1375).
","['patients with tuberculosis from a health system perspective', 'Between Aug 11, 2010, and Aug 11, 2015, 10\u2008964 index patients and 25\u2008707 household contacts', '70 districts across eight provinces of Vietnam', 'Patients aged 15 years and older with smear-positive pulmonary tuberculosis were recruited to the trial if they lived with one or more other household members', 'There were 10\u2008069 household contacts in the intervention group and 15\u2008638 household contacts in the control group']",['ACT2'],"['costs and cost-effectiveness', 'incremental cost-effectiveness ratio per DALY averted', 'disability-adjusted life years (DALYs) averted over a 24-month period']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0282620', 'cui_str': 'Adjusted Life Years'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",,0.343951,"The incremental cost-effectiveness ratio per DALY averted was $544 (330-1375).
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lung', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, NSW, Australia; Faculty of Medicine and Health, University of Sydney, NSW, Australia. Electronic address: tlung@georgeinstitute.org.au.'}, {'ForeName': 'Guy B', 'Initials': 'GB', 'LastName': 'Marks', 'Affiliation': 'South Western Sydney Clinical School, University of New South Wales, Kensington, NSW, Australia; Woolcock Institute of Medical Research, Glebe, NSW, Australia.'}, {'ForeName': 'Nguyen Viet', 'Initials': 'NV', 'LastName': 'Nhung', 'Affiliation': 'National Lung Hospital, Ba Dinh, Hanoi, Vietnam; Hanoi Medical University, Hanoi, Vietnam.'}, {'ForeName': 'Nguyen Thu', 'Initials': 'NT', 'LastName': 'Anh', 'Affiliation': 'Woolcock Institute of Medical Research, Glebe, NSW, Australia.'}, {'ForeName': 'Nghiem Le Phuong', 'Initials': 'NLP', 'LastName': 'Hoa', 'Affiliation': 'Woolcock Institute of Medical Research, Glebe, NSW, Australia.'}, {'ForeName': 'Le Thi Ngoc', 'Initials': 'LTN', 'LastName': 'Anh', 'Affiliation': 'Woolcock Institute of Medical Research, Glebe, NSW, Australia.'}, {'ForeName': 'Nguyen Binh', 'Initials': 'NB', 'LastName': 'Hoa', 'Affiliation': 'National Lung Hospital, Ba Dinh, Hanoi, Vietnam; Centre for Operational Research, International Union Against Tuberculosis and Lung Disease, Paris, France.'}, {'ForeName': 'Warwick John', 'Initials': 'WJ', 'LastName': 'Britton', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, NSW, Australia; Centenary Institute of Cancer Medicine and Cell Biology, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Bestrashniy', 'Affiliation': 'Woolcock Institute of Medical Research, Glebe, NSW, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jan', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, NSW, Australia; Faculty of Medicine and Health, University of Sydney, NSW, Australia.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Fox', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, NSW, Australia; Woolcock Institute of Medical Research, Glebe, NSW, Australia.'}]",The Lancet. Global health,['10.1016/S2214-109X(18)30520-5']
1257,31742849,Five-year results of a modified left atrial maze IV procedure in the treatment of atrial fibrillation: a randomized study.,"BACKGROUND


The left atrial maze IV (LAM-IV) alone has been used to eliminate atrial fibrillation (AF) without severe right heart diseases. However, we felt that it could be improved and developed a modified LAM-IV (MLAM-IV). In this prospective trial, we aimed to investigate 5-year clinical outcomes of AF in patients treated by the novel MLAM-IV technique.
METHODS


Between September 2012 and October 2013, 120 patients who underwent valve surgery and bipolar radiofrequency ablation for AF were randomized into the LAM-IV group (n = 60) or MLAM-IV group (n = 60). At postoperative follow-up examinations, data were recorded at 1, 3 and 6 months, and annually thereafter.
RESULTS


The mean ablation time and postoperative ventilation time were shorter in the MLAM-IV group than in the LAM-IV group (P < 0.001 and P = 0.03, respectively). At 5 years, the rate of freedom from AF was 69.0% in the MLAM-IV group and 60.0% in the LAM-IV group (hazard ratio 0.71, 95% confidence interval 0.39 to 1.32, P = 0.42). There were no differences with respect to the early operative mortality and major complications, late mortality, and major adverse events.
CONCLUSIONS


The MLAM-IV provides a technically simpler ablation process. The MLAM-IV was associated with less ventilation support in the early postoperative period. The long-term efficacy of the MLAM-IV in the treatment of AF is comparable to that of the LAM-IV.",2020,"The mean ablation time and postoperative ventilation time were shorter in the MLAM-IV group than in the LAM-IV group (P < 0.001 and P = 0.03, respectively).","['atrial fibrillation', 'Between September 2012 and October 2013, 120 patients who underwent', 'patients treated by the novel MLAM-IV technique']","['modified left atrial maze IV procedure', 'MLAM-IV', 'LAM-IV group (n =\u200960) or MLAM-IV group', 'valve surgery and bipolar radiofrequency ablation for AF']","['rate of freedom from AF', 'mean ablation time and postoperative ventilation time', 'early operative mortality and major complications, late mortality, and major adverse events']","[{'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0065041', 'cui_str': 'lipoarabinomannan'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",120.0,0.0358957,"The mean ablation time and postoperative ventilation time were shorter in the MLAM-IV group than in the LAM-IV group (P < 0.001 and P = 0.03, respectively).","[{'ForeName': 'Dengshen', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Huayan', 'Initials': 'H', 'LastName': 'Quan', 'Affiliation': 'West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Yingqiang', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}]",ANZ journal of surgery,['10.1111/ans.15486']
1258,30584025,The role of weight gain in explaining the effects of antipsychotic drugs on positive and negative symptoms: An analysis of the CATIE schizophrenia trial.,"Second-generation antipsychotics are associated with moderate benefits in terms of improved schizophrenia symptoms, but also with higher rates of side-effects such as excessive weight gain (WG); a consensus on their efficacy has not been reached. To date, no study has evaluated the interplay of treatments and side-effects in a single framework, which is a critical step to clarify the role of side-effects in explaining the efficacy of these antipsychotics. We used recent methods for mediation and interaction to clarify the role of WG in explaining the effects of second-generation drugs on schizophrenia symptoms. We used data from 1460 participants in the CATIE trial, assigned to either perphenazine (first-generation comparison drug), olanzapine, quetiapine, risperidone, or ziprasidone. The primary outcome was an individual's score on the Positive and Negative Syndrome Scale (PANSS) for symptoms of schizophrenia after 9 months, separately evaluated as positive (PANSS+), negative (PANSS-), and total PANSS score. WG after 6 months was investigated as a potential mediator and effect modifier. Results showed that, by limiting WG, patients would benefit of a considerably better improvement in terms of PANSS symptoms. In the scenario of weight change being controlled between -2% and 1% for all participants, patients assigned to olanzapine would experience the highest significant improvements in both PANSS+ (-2.66 points; 95% CI: -4.98, -0.35), PANSS- (-1.59; 95% CI: -4.31, 1.14), and total PANSS (-6.11; 95% CI: -13.13, 0.92). In conclusion, occurrence of excessive WG hampers the potentially beneficial effects of second-generation antipsychotics, thus suggesting future directions for treatment and interventions.",2019,"Second-generation antipsychotics are associated with moderate benefits in terms of improved schizophrenia symptoms, but also with higher rates of side-effects such as excessive weight gain (WG); a consensus on their efficacy has not been reached.","['1460 participants in the CATIE trial, assigned to either']","['antipsychotic drugs', 'olanzapine, quetiapine, risperidone, or ziprasidone', 'olanzapine', 'perphenazine']","['PANSS symptoms', 'positive (PANSS+), negative (PANSS-), and total PANSS score', ""individual's score on the Positive and Negative Syndrome Scale (PANSS) for symptoms of schizophrenia"", 'weight gain', 'positive and negative symptoms']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0380393', 'cui_str': 'ziprasidone'}, {'cui': 'C0031184', 'cui_str': 'Perphenazine'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",1460.0,0.0386453,"Second-generation antipsychotics are associated with moderate benefits in terms of improved schizophrenia symptoms, but also with higher rates of side-effects such as excessive weight gain (WG); a consensus on their efficacy has not been reached.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bellavia', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, United States of America; Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, United States of America.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Centorrino', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Jackson', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, United States of America; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States of America.'}, {'ForeName': 'Garrett', 'Initials': 'G', 'LastName': 'Fitzmaurice', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, United States of America; Department of Psychiatry, Harvard Medical School, Boston, MA, United States of America; Laboratory for Psychiatric Biostatistics, McLean Hospital, Belmont, MA, United States of America.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Valeri', 'Affiliation': 'Department of Biostatistics, Columbia University Mailman School of Public Health, New York, NY, United States of America. Electronic address: lv2424@cumc.columbia.edu.'}]",Schizophrenia research,['10.1016/j.schres.2018.12.006']
1259,30704873,Intrauterine metformin exposure and offspring cardiometabolic risk factors (PedMet study): a 5-10 year follow-up of the PregMet randomised controlled trial.,"BACKGROUND


Metformin is increasingly used to treat gestational diabetes and type 2 diabetes in pregnancy, and in attempts to improve pregnancy outcomes in polycystic ovary syndrome and obesity. It passes across the placenta with possible long-term consequences for the offspring. We previously explored the effect of metformin, given to women with polycystic ovary syndrome during pregnancy, on children's growth up to 4 years of age. In this 5-10 year follow-up, we examined the cardiometabolic risk factors in these children.
METHODS


This is a follow-up of children from the PregMet study, a double-blind, randomised controlled trial comparing metformin with placebo in polycystic ovary syndrome pregnancies. In the PregMet study, between Feb 4, 2005, and Jan 27, 2009, 257 pregnant women aged 18-45 years with polycystic ovary syndrome according to the Rotterdam criteria were included with 274 singleton pregnancies at 5-12 weeks of gestation at 11 study centres in Norway. 17 women participated twice. Pregnant women were randomised to metformin (2000 mg/day) or placebo from inclusion in the first trimester to birth. Randomisation was stratified according to metformin use at conception. In this follow-up, the primary endpoint was body-mass index (BMI) in the offspring at 5-10 years of age assessed by the standard deviation score (Z score). The primary endpoint was analysed with independent sample t tests. ClinicalTrials.gov number NCT00159536.
FINDINGS


Of the 255 invited children from the PregMet study, 141 (55%) consented to participate and were included between April 29, 2014, and July 12, 2016. Maternal baseline characteristics in the first trimester were similar between groups. Children in the metformin group had a higher BMI Z score than those in the placebo group (difference in means=0·41, 95% CI 0·03-0·78, p=0·03).
INTERPRETATION


The increased BMI in metformin-exposed children might indicate a potential risk of inferior cardiometabolic health. Implications for adult health cannot be excluded.
FUNDING


The Research Council of Norway, Novo Nordisk Foundation, St Olavs University Hospital, and the Norwegian University of Science and Technology.",2019,"Children in the metformin group had a higher BMI Z score than those in the placebo group (difference in means=0·41, 95% CI 0·03-0·78, p=0·03).
","[""women with polycystic ovary syndrome during pregnancy, on children's growth up to 4 years of age"", '17 women participated twice', '257 pregnant women aged 18-45 years with polycystic ovary syndrome according to the Rotterdam criteria were included with 274 singleton pregnancies at 5-12 weeks of gestation at 11 study centres in Norway', 'Of the 255 invited children from the PregMet study, 141 (55%) consented to participate and were included between April 29, 2014, and July 12, 2016', 'polycystic ovary syndrome pregnancies', 'Pregnant women']","['Intrauterine metformin', 'placebo', 'metformin', 'metformin with placebo', 'Metformin']","['cardiometabolic risk factors', 'BMI', 'Maternal baseline characteristics', 'body-mass index (BMI', 'BMI Z score']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C0694756', 'cui_str': 'Intrauterine (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",17.0,0.265124,"Children in the metformin group had a higher BMI Z score than those in the placebo group (difference in means=0·41, 95% CI 0·03-0·78, p=0·03).
","[{'ForeName': 'Liv Guro Engen', 'Initials': 'LGE', 'LastName': 'Hanem', 'Affiliation': 'Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway. Electronic address: liv.g.e.hanem@ntnu.no.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Salvesen', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Petur B', 'Initials': 'PB', 'LastName': 'Juliusson', 'Affiliation': 'Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway; Department of Health Registries, Norwegian Institute of Public Health, Sentrum, Bergen, Norway; Department of Clinical Science, University of Bergen, Bergen, Norway; Department of Pediatrics, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Sven M', 'Initials': 'SM', 'LastName': 'Carlsen', 'Affiliation': 'Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway; Department of Endocrinology, St. Olavs Hospital, Trondheim University Hospital, Torgarden, Trondheim, Norway.'}, {'ForeName': 'Marit Cecilie Fonn', 'Initials': 'MCF', 'LastName': 'Nossum', 'Affiliation': 'Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Marte Øye', 'Initials': 'MØ', 'LastName': 'Vaage', 'Affiliation': 'Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Rønnaug', 'Initials': 'R', 'LastName': 'Ødegård', 'Affiliation': 'Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway; Centre for Obesity Research, St. Olavs Hospital, Trondheim University Hospital, Torgarden, Trondheim, Norway.'}, {'ForeName': 'Eszter', 'Initials': 'E', 'LastName': 'Vanky', 'Affiliation': 'Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway; Department of Obstetrics and Gynecology, St. Olavs Hospital, Trondheim University Hospital, Torgarden, Trondheim, Norway.'}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(18)30385-7']
1260,32408245,"The impact of a three-phase video-assisted debriefing on nursing students' debriefing experiences, perceived stress and facilitators' practices: A mixed methods study.","BACKGROUND


As an integral part of simulation, debriefing helps learners to construct knowledge through reflecting, internalizing, and relating. Video-assisted debriefing (VAD) adds audio-visual captures and reviews to support traditional verbal debriefing (VD), but evidence evaluating its educational effects has been mixed, with limited attention focusing on its structure development.
AIMS


This study aimed to 1) investigate the effects of a three-phase VAD in enhancing nursing students' debriefing experiences and perceived stress compared to VD and 2) to explore its impact on facilitators' debriefing practices.
METHODS


A mixed-methods design was adopted. The quantitative phase involved a prospective controlled trial on 145 nursing students from a university in Singapore who were randomized into the intervention cluster (n = 72) and the control cluster (n = 73). The debriefing experience scale (DES), the stress visual analogue scale (Stress VAS), and the debriefing assessment for simulation in healthcare (DASH© student version) were used as outcome measures. For the qualitative component, a purposive sample of eight facilitators evaluated their own debriefing practices using the DASH© instructor version and each completed an open-ended question survey. Qualitative data were analyzed using content analysis.
RESULTS


Students from the intervention cluster significantly improved their debriefing experiences (p = 0.01), experienced comparable stress, and had better impressions of VAD facilitators' practices (p < 0.001) compared to those in the control cluster. Repeated VAD significantly reduced students' stress (p < 0.001). Students viewed the VAD facilitators as more effective than the VD facilitators. Three categories were derived from the qualitative comments: the act of debriefing, the crux of VAD, and debriefing for success.
CONCLUSION


The three-phase VAD significantly improved nursing students' debriefing experiences without adding extra stress. It also helped to improve facilitators' practices. Future research will benefit from exploring how experts facilitate the three-phase VAD ""on the ground"" and its effect on learning transfer and cost-effectiveness.",2020,"RESULTS


Students from the intervention cluster significantly improved their debriefing experiences (p = 0.01), experienced comparable stress, and had better impressions of VAD facilitators' practices (p < 0.001) compared to those in the control cluster.",['145 nursing students from a university in Singapore who were randomized into the intervention cluster (n\xa0=\xa072) and the control cluster (n\xa0=\xa073'],"['Video-assisted debriefing (VAD', 'three-phase video-assisted debriefing']","[""impressions of VAD facilitators' practices"", 'debriefing experience scale (DES), the stress visual analogue scale (Stress VAS), and the debriefing assessment for simulation in healthcare (DASH© student version', 'debriefing experiences']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",145.0,0.0300089,"RESULTS


Students from the intervention cluster significantly improved their debriefing experiences (p = 0.01), experienced comparable stress, and had better impressions of VAD facilitators' practices (p < 0.001) compared to those in the control cluster.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Sweden and Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: nurzh@nus.edu.sg.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: nurww@nus.edu.sg.'}, {'ForeName': 'S H L', 'Initials': 'SHL', 'LastName': 'Goh', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: nurghs@nus.edu.sg.'}, {'ForeName': 'X V', 'Initials': 'XV', 'LastName': 'Wu', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: nurwux@nus.edu.sg.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mörelius', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Sweden and School of Nursing and Midwifery, Edith Cowan University, Joondalup, Western Australia, Australia. Electronic address: e.morelius@ecu.edu.au.'}]",Nurse education today,['10.1016/j.nedt.2020.104460']
1261,30762289,Aiming for the optimal bicarbonate prescription for maintenance hemodialysis therapy in end-stage renal disease.,"INTRODUCTION


Acidemia and alkalemia, as a result of gradual depletion of the body's buffers followed by rapid repletion during hemodialysis (HD), are linked to adverse consequences. We examined the acid-base status with dialysis bath of higher bicarbonate (HC03 -  ) concentration or standard HC03 -  bath plus oral HC03 -  supplementation.
METHODS


A total of 60 stable HD patients (pts) were evaluated according to their pre-dialysis acid-base status both before the first and the second session of the week dialyzed against standard base dialysate of 35 mmol/L. Those who presented predialysis HC03 -  <22 mmol/L (25 pts) were assigned to dialysis against bath of increased HC03 -  levels (37 mmol/L) for 2 weeks (period A) and subsequently to dialysis with the standard dialysate bath plus daily oral sodium bicarbonate at a dose of 5 g/day for 2 weeks (period B). Pre and post-dialysis acid-base status at each study period and relevant laboratory tests were recorded.
FINDINGS


Pre-dialysis acid-base values were similar between the first and the second dialysis session. Twenty-five points had pre-dialysis pH <7.35, while 42 (the younger ones) presented pre-dialysis HC03 -  <22 mmol/L. After dialysis session 18 pts had pH >7.45. Comparing the two study periods, interdialytic weight was similar, pre-dialysis HC03 -  levels were improved with oral bicarbonate, while post-dialysis HC03 -  were higher during period A. Three pts could not tolerate the symptoms of alkalemia during period A.
DISCUSSION


The impact of conventional HC03 -  concentrations of 35 mmol/L results in a considerable degree of pre-dialysis acidemia. Increasing the HC03 -  in bath results in more prominent post-dialysis alkalemia, however, it is not sufficient to maintain acid-base status during the interdialytic period. Oral bicarbonate supplement at a dose of 5 g/day (divided in three daily doses) results in a more balanced acid-base status, avoiding post-dialysis alkalemia.",2019,"Comparing the two study periods, interdialytic weight was similar, pre-dialysis HC03 -  levels were improved with oral bicarbonate, while post-dialysis HC03 -  were higher during period A. Three pts could not tolerate the symptoms of alkalemia during period A.
DISCUSSION


The impact of conventional HC03 -  concentrations of 35 mmol/L results in a considerable degree of pre-dialysis acidemia.","['60 stable HD patients (pts', 'end-stage renal disease']","['oral bicarbonate', 'dialysis bath of higher bicarbonate (HC03 -  ) concentration or standard HC03 -  bath plus oral HC03 -  supplementation', 'dialyzed against standard base dialysate of 35 mmol/L. Those who presented predialysis HC03 -  <22 mmol/L (25 pts) were assigned to dialysis against bath of increased HC03 -  levels (37 mmol/L) for 2 weeks (period A) and subsequently to dialysis with the standard dialysate bath plus daily oral sodium bicarbonate', 'bicarbonate prescription', 'Oral bicarbonate supplement']","['interdialytic weight was similar, pre-dialysis HC03 -  levels']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0005367', 'cui_str': 'Hydrogen Carbonates'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0150141'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0011947', 'cui_str': 'Dialyzates'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1264634', 'cui_str': 'Pre-dialysis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",60.0,0.0386873,"Comparing the two study periods, interdialytic weight was similar, pre-dialysis HC03 -  levels were improved with oral bicarbonate, while post-dialysis HC03 -  were higher during period A. Three pts could not tolerate the symptoms of alkalemia during period A.
DISCUSSION


The impact of conventional HC03 -  concentrations of 35 mmol/L results in a considerable degree of pre-dialysis acidemia.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Bozikas', 'Affiliation': 'General Hospital of Thessaloniki ""Agios Pavlos"", Nephrology Department, Thessaloniki, Greece.'}, {'ForeName': 'Iliana', 'Initials': 'I', 'LastName': 'Kiriakoutzik', 'Affiliation': 'General Hospital of Thessaloniki ""Agios Pavlos"", Nephrology Department, Thessaloniki, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Petrou', 'Affiliation': 'General Hospital of Thessaloniki ""Agios Pavlos"", Nephrology Department, Thessaloniki, Greece.'}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Touroutzis', 'Affiliation': 'General Hospital of Thessaloniki ""Agios Pavlos"", Nephrology Department, Thessaloniki, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Kitoukidi', 'Affiliation': 'General Hospital of Thessaloniki ""Agios Pavlos"", Nephrology Department, Thessaloniki, Greece.'}, {'ForeName': 'Pinelopi', 'Initials': 'P', 'LastName': 'Pisanidou', 'Affiliation': 'General Hospital of Thessaloniki ""Agios Pavlos"", Nephrology Department, Thessaloniki, Greece.'}, {'ForeName': 'Styliani', 'Initials': 'S', 'LastName': 'Vakiani', 'Affiliation': 'General Hospital of Thessaloniki ""Agios Pavlos"", Nephrology Department, Thessaloniki, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Georgilas', 'Affiliation': 'General Hospital of Thessaloniki ""Agios Pavlos"", Nephrology Department, Thessaloniki, Greece.'}, {'ForeName': 'Antigoni', 'Initials': 'A', 'LastName': 'Martika', 'Affiliation': 'General Hospital of Thessaloniki ""Agios Pavlos"", Nephrology Department, Thessaloniki, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Pangidis', 'Affiliation': 'General Hospital of Thessaloniki ""Agios Pavlos"", Nephrology Department, Thessaloniki, Greece.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Spaia', 'Affiliation': 'General Hospital of Thessaloniki ""Agios Pavlos"", Nephrology Department, Thessaloniki, Greece.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12710']
1262,32408166,Using immersive virtual reality to modify body image.,"We tested the efficacy of a training programme, delivered in virtual reality (VR), to modify the perceptual boundary between what participants classify as a fat versus a thin body. Three cohorts of 20 female volunteers with high body image concerns were recruited to two intervention groups and one control group. All participants completed a 4-day training programme in VR where they categorised a series of 3D models as either thin or fat; one intervention group was presented with the stimuli briefly, while the other group had no time limits imposed. Both intervention groups were given inflationary feedback to shift their categorisations of the stimulus models towards higher BMIs. Our results show that, compared to controls, both intervention groups shifted their categorical boundaries between Day 1 and follow-up on Day 14. Unlimited stimulus presentation times were associated with a larger training effect. Furthermore, both intervention groups experienced statistically significant reductions in their concerns about their own body shape, weight and eating habits. However, only in the group with longer stimulus presentation times were these reductions consistent with a clinically meaningful effect. These findings suggest that manipulating categorical perception in VR might provide a complementary addition to existing treatments for eating disorders.",2020,"Our results show that, compared to controls, both intervention groups shifted their categorical boundaries between Day 1 and follow-up on Day 14.",['20 female volunteers with high body image concerns'],"['training programme, delivered in virtual reality (VR', '4-day training programme']","['body shape, weight and eating habits']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",20.0,0.01014,"Our results show that, compared to controls, both intervention groups shifted their categorical boundaries between Day 1 and follow-up on Day 14.","[{'ForeName': 'Kamila R', 'Initials': 'KR', 'LastName': 'Irvine', 'Affiliation': 'Department of Psychology, Faculty of health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE1 8ST, UK. Electronic address: kirvine@lincoln.ac.uk.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Irvine', 'Affiliation': 'Virtual Research Innovations Ltd., UK; School of Psychology, College of Social Science, University of Lincoln, Lincolnshire, LN6 7TS, UK.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Maalin', 'Affiliation': 'School of Psychology, College of Social Science, University of Lincoln, Lincolnshire, LN6 7TS, UK.'}, {'ForeName': 'Kristofor', 'Initials': 'K', 'LastName': 'McCarty', 'Affiliation': 'Department of Psychology, Faculty of health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE1 8ST, UK.'}, {'ForeName': 'Katri K', 'Initials': 'KK', 'LastName': 'Cornelissen', 'Affiliation': 'Department of Psychology, Faculty of health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE1 8ST, UK.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Tovée', 'Affiliation': 'Department of Psychology, Faculty of health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE1 8ST, UK.'}, {'ForeName': 'Piers L', 'Initials': 'PL', 'LastName': 'Cornelissen', 'Affiliation': 'Department of Psychology, Faculty of health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE1 8ST, UK.'}]",Body image,['10.1016/j.bodyim.2020.03.007']
1263,31900815,Preventive Epidural Analgesia in Bilateral Single-Stage Knee Arthroplasty: A Randomized Controlled Trial.,"INTRODUCTION


Although controversial, pre-emptive analgesia has shown some promise in preventing altered pain perception and reducing pain amplification after surgery. Hence, it has the potential to be more effective than a similar analgesic regimen started after surgery with an appropriate combination of patient category and analgesic modality. Hence, the present study was undertaken to evaluate the effect of preventive epidural analgesia in reducing pain severity and duration after bilateral single-stage knee arthroplasty.
METHODS


Fifty patients, 18-70 years, with American Society of Anesthesiologists physical status class I & II posted for bilateral single-stage knee replacement under regional anesthesia were randomly allocated into preventive versus postoperative epidural analgesia group to compare severity of post-operative pain, analgesic consumption, day of mobilization, C-reactive protein (CRP) levels, and hospital stay.
RESULTS


The pain score after surgery [2.0 (1.5, 2.0); 3.0 (1.5, 3.0), p = 0.005] and day of mobilization [(2. 92 ± 0. 28; 3. 31 ± 0. 48; p value 0.02)] were significantly lesser in the preventive epidural group. However, there was no difference in the hospital stay (9.92 ± 3.71 and 9.00 ± 2.12, p = 0.95) and analgesic consumption (65.38 ± 37.55 and 73.08 ± 43.85, p = 0.30). The preventive group had a larger drop in CRP and experienced a lesser number of days with pain after surgery as compared to the controls [(64.29 ± 21.29); (142.37 ± 80.04), p = 0.0001]. Six patients in the preemptive group (24%) and 13 of the control group (24 vs. 56.5%; p = 0.02) had chronic postsurgical pain.
CONCLUSIONS


Preventive epidural analgesia reduces the severity and number of chronic pain days after bilateral single-stage knee replacement.
TRIAL REGISTRATION


The study was registered in the Indian national registry (CTRI/2017/03/008240 on 28/03/2017).",2020,"The preventive group had a larger drop in CRP and experienced a lesser number of days with pain after surgery as compared to the controls [(64.29 ± 21.29); (142.37 ± 80.04), p = 0.0001].","['Bilateral Single-Stage Knee Arthroplasty', 'Fifty patients, 18-70\xa0years, with American Society of Anesthesiologists physical status class', 'after bilateral single-stage knee replacement', 'after bilateral single-stage knee arthroplasty', 'I & II posted for bilateral single-stage knee replacement under regional anesthesia']","['Preventive Epidural Analgesia', 'preventive epidural analgesia']","['hospital stay', 'severity of post-operative pain, analgesic consumption, day of mobilization, C-reactive protein (CRP) levels, and hospital stay', 'pain amplification', 'number of days with pain', 'pain score', 'severity and number of chronic pain days', 'pain severity and duration', 'chronic postsurgical pain', 'analgesic consumption']","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0578808', 'cui_str': 'American Society of Anesthesiologists physical status class'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0002911', 'cui_str': 'Anesthesia, Regional'}]","[{'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]",50.0,0.162012,"The preventive group had a larger drop in CRP and experienced a lesser number of days with pain after surgery as compared to the controls [(64.29 ± 21.29); (142.37 ± 80.04), p = 0.0001].","[{'ForeName': 'Parnandi Bhaskar', 'Initials': 'PB', 'LastName': 'Rao', 'Affiliation': 'Department of Anaesthesiology, All India Institute of Medical Science, Sijua, Bhubaneswar, India. drbhaskar.com@gmail.com.'}, {'ForeName': 'Indraprava', 'Initials': 'I', 'LastName': 'Mandal', 'Affiliation': 'Department of Anaesthesiology, All India Institute of Medical Science, Sijua, Bhubaneswar, India.'}, {'ForeName': 'Sujit', 'Initials': 'S', 'LastName': 'Tripathy', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Science, Sijua, Bhubaneswar, India.'}, {'ForeName': 'Debapriya', 'Initials': 'D', 'LastName': 'Bandyopadhyay', 'Affiliation': 'Department of Biochemistry, All India Institute of Medical Science, Sijua, Bhubaneswar, India.'}, {'ForeName': 'Swagata', 'Initials': 'S', 'LastName': 'Tripathy', 'Affiliation': 'Department of Anaesthesiology, All India Institute of Medical Science, Sijua, Bhubaneswar, India.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesiology, All India Institute of Medical Science, Sijua, Bhubaneswar, India.'}, {'ForeName': 'Aparajita', 'Initials': 'A', 'LastName': 'Panda', 'Affiliation': 'Department of Anaesthesiology, All India Institute of Medical Science, Sijua, Bhubaneswar, India.'}]",Pain and therapy,['10.1007/s40122-019-00145-4']
1264,31693918,The prebiotic effect of CPP-ACP sugar-free chewing gum.,"OBJECTIVES


To determine if chewing gum containing casein phosphopeptide stabilised amorphous calcium phosphate (CPP-ACP) promoted an increase in the abundance of Streptococcus sanguinis and other species associated with dental health in supragingival plaque in a clinical study.
MATERIALS AND METHODS


Nineteen participants were recruited for a three-leg cross-over, randomised, controlled clinical trial. Participants chewed a sugar-free gum with or without CPP-ACP six times daily for 20 min over two weeks. The study also involved no gum chewing (no gum) for the same two week period. Participants were randomly assigned to one of the test gums or no gum for each intervention period. Participants abstained from oral hygiene and had washout periods of two weeks between intervention periods. After each intervention period, supragingival plaque was collected and analysed for bacterial composition by sequencing the V4 variable region of the 16S rRNA gene. Data were analysed using a linear mixed model.
RESULTS


The CPP-ACP gum intervention produced a significant (p < 0.01) increase in the proportions of S. sanguinis (112%), as well as the commensal species Rothia dentocariosa (127%), Corynebacterium durum (80%) and Streptococcus mitis (55%) when compared with the no gum intervention. All the species that were promoted by the CPP-ACP gum are known to possess one or both of the alkali-producing enzymes arginine deiminase and nitrate reductase.
CONCLUSION


This clinical study demonstrated that chewing a sugar-free gum containing CPP-ACP promoted prebiosis by significantly increasing the proportion of S. sanguinis and other health-associated bacterial species in supragingival plaque.
CLINICAL SIGNIFICANCE


Regular chewing of CPP-ACP sugar-free gum increases the proportions of health-associated commensal species in supragingival plaque to promote prebiosis and oral homeostasis.",2019,"The CPP-ACP gum intervention produced a significant (p < 0.01) increase in the proportions of S. sanguinis (112%), as well as the commensal species Rothia dentocariosa (127%), Corynebacterium durum (80%) and Streptococcus mitis (55%) when compared with the no gum intervention.",['Nineteen participants were recruited for a three-leg cross'],"['chewing gum containing casein phosphopeptide stabilised amorphous calcium phosphate (CPP-ACP', 'test gums or no gum', 'sugar-free gum with or without CPP-ACP', 'CPP-ACP sugar-free gum', 'CPP-ACP Sugar-Free Chewing Gum']","['proportions of S. sanguinis', 'supragingival plaque']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}]","[{'cui': 'C4321298', 'cui_str': 'Chewing gum'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0031684', 'cui_str': 'Phosphopeptides'}, {'cui': 'C1956739', 'cui_str': 'Ca9(PO4)6'}, {'cui': 'C1120338', 'cui_str': 'casein phosphopeptide-amorphous calcium phosphate nanocomplex'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1378701', 'cui_str': 'Gum (basic dose form)'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}]","[{'cui': 'C0399452', 'cui_str': 'Supragingival dental plaque (disorder)'}]",19.0,0.0149478,"The CPP-ACP gum intervention produced a significant (p < 0.01) increase in the proportions of S. sanguinis (112%), as well as the commensal species Rothia dentocariosa (127%), Corynebacterium durum (80%) and Streptococcus mitis (55%) when compared with the no gum intervention.","[{'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Fernando', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Butler', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Geoffrey G', 'Initials': 'GG', 'LastName': 'Adams', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Helen L', 'Initials': 'HL', 'LastName': 'Mitchell', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Stuart G', 'Initials': 'SG', 'LastName': 'Dashper', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Escobar', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Hoffmann', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Peiyan', 'Initials': 'P', 'LastName': 'Shen', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Glenn D', 'Initials': 'GD', 'LastName': 'Walker', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'Reynolds', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Reynolds', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia. Electronic address: e.reynolds@unimelb.edu.au.'}]",Journal of dentistry,['10.1016/j.jdent.2019.103225']
1265,30768161,A 14 day esomeprazole- and amoxicillin-containing high-dose dual therapy regimen achieves a high eradication rate as first-line anti-Helicobacter pylori treatment in Taiwan: a prospective randomized trial.,"BACKGROUND


The first-line eradication rate of standard triple therapy for Helicobacter pylori infection has declined to <80%, and alternative therapies with >90% success rates are needed. Inconsistent eradication rates were reported for proton pump inhibitor- and amoxicillin-containing high-dose dual therapy.
OBJECTIVES


We performed a prospective, randomized controlled study to assess the efficacy of esomeprazole- and amoxicillin-containing high-dose dual therapy and investigated the influencing clinical factors.
PATIENTS AND METHODS


We recruited 240/278 eligible H. pylori-infected patients after exclusion. They were randomly assigned to 14 day high-dose dual therapy (esomeprazole 40 mg three times daily and amoxicillin 750 mg four times daily for 14 days; EA group) or 7 day non-bismuth quadruple therapy (esomeprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days; EACM group). Urea breath tests were followed up 8 weeks later.
RESULTS


The eradication rates for the EA and EACM groups were 91.7% (95% CI = 85.3%-96.0%) and 86.7% (95% CI = 79.3%-92.2%) (P = 0.21) in ITT analysis; and 95.7% (95% CI = 90.2%-98.6%) and 92.0% (95% CI = 85.4%-96.3%) (P = 0.26) in PP analysis. The adverse event rates were 9.6% versus 23.0% in the two groups (P = 0.01). The H. pylori culture positivity rate was 91.8%. The antibiotic resistance rates were amoxicillin, 0%; clarithromycin, 14.6%; and metronidazole, 33.7%.
CONCLUSIONS


A 14 day esomeprazole- and amoxicillin-containing high-dose dual therapy achieves a high eradication rate as first-line anti-H. pylori therapy, comparable to that with 7 day non-bismuth quadruple therapy but with fewer adverse events.",2019,The eradication rates for the EA and EACM groups were 91.7% (95% CI = 85.3%-96.0%) and 86.7% (95% CI = 79.3%-92.2%) (P = 0.21) in ITT analysis; and 95.7% (95% CI = 90.2%-98.6%) and 92.0% (95% CI = 85.4%-96.3%) (P = 0.26) in PP analysis.,"['Taiwan', 'We recruited 240/278 eligible H. pylori-infected patients after exclusion']","['clarithromycin', 'amoxicillin', 'dual therapy (esomeprazole 40\u2009mg three times daily and amoxicillin 750\u2009mg four times daily for 14\u2009days; EA group) or 7\u2009day non-bismuth quadruple therapy (esomeprazole 40\u2009mg twice daily, clarithromycin 500\u2009mg twice daily, amoxicillin 1\u2009g twice daily and metronidazole', 'metronidazole', 'esomeprazole- and amoxicillin-containing high-dose dual therapy', 'esomeprazole- and amoxicillin-containing high-dose dual therapy regimen']","['Helicobacter pylori infection', 'H. pylori culture positivity rate', 'antibiotic resistance rates', 'adverse events', 'Urea breath tests', 'adverse event rates', 'eradication rates', 'eradication rate']","[{'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1127610', 'cui_str': 'Esomeprazole 40 MG'}, {'cui': 'C0556984', 'cui_str': 'Three times daily (qualifier value)'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0585291', 'cui_str': 'Four times daily (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0205175', 'cui_str': 'Quadruple (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0984982', 'cui_str': 'Clarithromycin 500 MG'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}]","[{'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance, Microbial'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C0006153', 'cui_str': 'Breath Tests'}]",,0.0367119,The eradication rates for the EA and EACM groups were 91.7% (95% CI = 85.3%-96.0%) and 86.7% (95% CI = 79.3%-92.2%) (P = 0.21) in ITT analysis; and 95.7% (95% CI = 90.2%-98.6%) and 92.0% (95% CI = 85.4%-96.3%) (P = 0.26) in PP analysis.,"[{'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Tai', 'Affiliation': 'Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Chih-Ming', 'Initials': 'CM', 'LastName': 'Liang', 'Affiliation': 'Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Chung-Mou', 'Initials': 'CM', 'LastName': 'Kuo', 'Affiliation': 'Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Pao-Yuan', 'Initials': 'PY', 'LastName': 'Huang', 'Affiliation': 'Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Cheng-Kun', 'Initials': 'CK', 'LastName': 'Wu', 'Affiliation': 'Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Shih-Cheng', 'Initials': 'SC', 'LastName': 'Yang', 'Affiliation': 'Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Yuan-Hung', 'Initials': 'YH', 'LastName': 'Kuo', 'Affiliation': 'Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Ming-Tsung', 'Initials': 'MT', 'LastName': 'Lin', 'Affiliation': 'Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Chen-Hsiang', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Chien-Ning', 'Initials': 'CN', 'LastName': 'Hsu', 'Affiliation': 'Department of Pharmacy, Kaohsiung Gang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Keng-Liang', 'Initials': 'KL', 'LastName': 'Wu', 'Affiliation': 'Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Tsung-Hui', 'Initials': 'TH', 'LastName': 'Hu', 'Affiliation': 'Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Seng-Kee', 'Initials': 'SK', 'LastName': 'Chuah', 'Affiliation': 'Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz046']
1266,30747564,The Feasibility of Remotely Delivered Exercise Session in Adults With Alzheimer's Disease and Their Caregivers.,"Adults with Alzheimer's disease (AD) and their caregivers represent a segment of the population with low levels of moderate-intensity physical activity (MPA) and limited options for increasing MPA. The purpose of this study was to evaluate the feasibility of a group video conference approach for increasing MPA in adults with AD and their caregivers. Adults with AD and their caregivers attended 30-min group exercise sessions three times per week for 12 weeks. Exercise sessions and support sessions were delivered in their homes on a tablet computer over video conferencing software. Nine adults with AD/caregiver dyads enrolled, and seven completed the 12-week intervention. Adults with AD attended 77.3% of the group exercise sessions, and caregivers attended 79.2% of group exercise sessions. Weekly MPA increased in both adults with AD (49%) and caregivers (30%). Exercise delivered by group video conferencing is a feasible and potentially effective approach for increasing MPA in adults with AD and their caregivers.",2019,Exercise delivered by group video conferencing is a feasible and potentially effective approach for increasing MPA in adults with AD and their caregivers.,"['Adults with AD and their caregivers', ""Adults with Alzheimer's disease (AD) and their caregivers represent a segment of the population with low levels of moderate-intensity physical activity (MPA) and limited options for increasing MPA"", ""Adults With Alzheimer's Disease and Their Caregivers"", 'Nine adults with AD/caregiver dyads enrolled, and seven completed the 12-week intervention', 'adults with AD and their caregivers']","['Remotely Delivered Exercise Session', 'Exercise delivered by group video conferencing']",['Weekly MPA'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]",9.0,0.0413417,Exercise delivered by group video conferencing is a feasible and potentially effective approach for increasing MPA in adults with AD and their caregivers.,"[{'ForeName': 'Lauren T', 'Initials': 'LT', 'LastName': 'Ptomey', 'Affiliation': ''}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Vidoni', 'Affiliation': ''}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Montenegro-Montenegro', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Thompson', 'Affiliation': ''}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Sherman', 'Affiliation': ''}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Gorczyca', 'Affiliation': ''}, {'ForeName': 'Jerry L', 'Initials': 'JL', 'LastName': 'Greene', 'Affiliation': ''}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Washburn', 'Affiliation': ''}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2018-0298']
1267,30740858,New modes of continuous renal replacement therapy using a refiltering technique to reduce micronutrient loss.,"INTRODUCTION


Micronutrient depletion is a major drawback of high-dose continuous renal replacement therapy (CRRT). We tested two novel CRRT modes, double-filtration hemofiltration (DHF) and dialysate-recycling hemodiafiltration (DHDF), aimed at reducing micronutrient loss while maintaining a high clearance rate of midsized solutes comparable to that of high-volume hemofiltration (HVHF).
METHODS


Forty patients with renal failure requiring CRRT were randomly assigned to receive predilutional standard-volume hemofiltration (SVHF, effluent rate 35 mL/kg/h), predilutional HVHF (100 mL/kg/h), DHF (35 mL/kg/h), and DHDF (30 mL/kg/h). In the two novel modes of CRRT, part of the high-volume primary effluent fluid produced by a high-flux filter (AV600S) was refiltered by two low-flux filters (15 L) for recycling as replacement fluid in DHF and dialysate in DHDF, while the remainder was discarded as final effluent fluid. Specimens were collected for measurement of trace elements, folic acid, amino acids (AAs), β2-microglobulin, cystatin C, and creatinine and for calculation of solute clearance.
FINDINGS


The clearance of 17 AAs, phosphorus, folic acid, copper, and zinc by DHF and DHDF was much lower than that by HVHF and comparable to that by SVHF. The estimated amount of AA loss by SVHF, HVHF, DHF, and DHDF was 10.3 (7.2-13.4) g/d, 22.1 (17.8-24.0) g/d, 10.6 (8.6-14.0) g/d, and 10.0 (8.6-11.4) g/d, respectively. Clearance of cystatin C and β2-microglobulin by DHF and DHDF was much greater than that by SVHF and equal to that by HVHF.
DISCUSSION


Compared to HVHF, DHF, and DHDF have an equal capacity for removal of large solutes but show substantially reduced micronutrient loss.",2019,"Clearance of cystatin C and β2-microglobulin by DHF and DHDF was much greater than that by SVHF and equal to that by HVHF.
",['Forty patients with renal failure requiring CRRT'],"['predilutional standard-volume hemofiltration (SVHF, effluent rate 35 mL/kg/h), predilutional HVHF', 'high-volume hemofiltration (HVHF', 'double-filtration hemofiltration (DHF) and dialysate-recycling hemodiafiltration (DHDF', 'DHF']","['clearance of 17 AAs, phosphorus, folic acid, copper, and zinc by DHF and DHDF', 'trace elements, folic acid, amino acids (AAs), β2-microglobulin, cystatin C, and creatinine and for calculation of solute clearance', 'AA loss by SVHF, HVHF, DHF, and DHDF', 'Clearance of cystatin C and β2-microglobulin by DHF and DHDF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0019014', 'cui_str': 'Hemofiltration'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0016107', 'cui_str': 'Filtration - action'}, {'cui': 'C0011947', 'cui_str': 'Dialyzates'}, {'cui': 'C0282114', 'cui_str': 'Recycling'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}]","[{'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0373587', 'cui_str': 'Copper measurement (procedure)'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0040577', 'cui_str': 'Trace Elements'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",40.0,0.0684729,"Clearance of cystatin C and β2-microglobulin by DHF and DHDF was much greater than that by SVHF and equal to that by HVHF.
","[{'ForeName': 'Buyun', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.'}, {'ForeName': 'Daxi', 'Initials': 'D', 'LastName': 'Ji', 'Affiliation': 'National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Fan', 'Affiliation': 'National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.'}, {'ForeName': 'Dehua', 'Initials': 'D', 'LastName': 'Gong', 'Affiliation': 'National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12709']
1268,30773797,Efficacy of the SEPARPROCATH® radiation drape to reduce radiation exposure during cardiac catheterization: A pilot comparative study.,"BACKGROUND


Interventional cardiologists are exposed to radiation-induced diseases, partly due to patient's scatter radiation.
OBJECTIVES


We sought to compare the radiation exposure (RE) of the cardiac catheterization room staff using SEPARPROCATH®, a novel radio-protective drape versus standard shielding equipment.
METHODS


This was a two-step prospective, randomized pilot trial: first, in experimental conditions using a phantom model, and second, during cardiac catheterization. Primary end-point was operator RE corresponding to the ratio between operator cumulative dose (CD) and dose area product (DAP). Secondary end-points were nurse RE, operator and nurse CD, DAP, and fluoroscopy time.
RESULTS


A total of 51 patients were included. SEPARPROCATH® was associated with a lower operator RE (0.07 [0-0.19] vs. 0.37 [0.23-0.81] μSv/Gy.cm 2  without SEPARPROCATH®, p value <0.0001) and lower nurse RE (0 [0-0.05] vs. 0.13 [0.03-0.28] μSv/Gy.cm 2  , p value <0.0001) corresponding to an RE relative risk reduction of 81% and 99%, respectively. Similar reductions were observed for operator and nurse CDs. No difference was found in DAP (19 [11-29] vs. 14 [10-32] Gy.cm 2  without SEPARPROCATH®, p value 0.81).
CONCLUSION


SEPARPROCATH® offers significant additional radioprotection to the operator and nurse during cardiac catheterization without affecting patient safety.",2019,"SEPARPROCATH® was associated with a lower operator RE (0.07 [0-0.19] vs. 0.37 [0.23-0.81] μSv/Gy.cm 2  without SEPARPROCATH®, p value <0.0001) and lower nurse RE (0 [0-0.05] vs. 0.13 [0.03-0.28] μSv/Gy.cm 2  , p value <0.0001) corresponding to an RE relative risk reduction of 81% and 99%, respectively.","['cardiac catheterization', 'A total of 51 patients were included']","['SEPARPROCATH® radiation drape', 'SEPARPROCATH®']","['lower nurse RE', 'nurse RE, operator and nurse CD, DAP, and fluoroscopy time', 'operator RE corresponding to the ratio between operator cumulative dose (CD) and dose area product (DAP', 'DAP']","[{'cui': 'C0018795', 'cui_str': 'Catheterization, Heart'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0525921', 'cui_str': 'alpha,beta-diacryloxypropionic acid'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",51.0,0.0353946,"SEPARPROCATH® was associated with a lower operator RE (0.07 [0-0.19] vs. 0.37 [0.23-0.81] μSv/Gy.cm 2  without SEPARPROCATH®, p value <0.0001) and lower nurse RE (0 [0-0.05] vs. 0.13 [0.03-0.28] μSv/Gy.cm 2  , p value <0.0001) corresponding to an RE relative risk reduction of 81% and 99%, respectively.","[{'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Patet', 'Affiliation': 'Department of Cardiology, University and Hospital of Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Ryckx', 'Affiliation': 'Department of Radiation Physics, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Arroyo', 'Affiliation': 'Department of Cardiology, University and Hospital of Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': 'Department of Cardiology, University and Hospital of Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Goy', 'Affiliation': 'Department of Cardiology, University and Hospital of Fribourg, Fribourg, Switzerland.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28130']
1269,25179153,A novel approach to reduce radial artery occlusion after transradial catheterization: postprocedural/prehemostasis intra-arterial nitroglycerin.,"OBJECTIVE


To evaluate whether administration of nitroglycerin through the sheath at the end of a transradial procedure might preserve the patency of the radial artery.
BACKGROUND


Despite the increasing acceptance of transradial approach, radial artery occlusion (RAO) continues to be a vexing problem of transradial access and limits utility of the radial artery as an access site in the future.
METHODS


We conducted a multicenter, prospective, randomized, placebo-controlled, operator-blinded trial and enrolled 1,706 patients who underwent transradial catheterization in three experienced radial centers. Patients were randomized to receive either 500 µg nitroglycerin (n=853) or placebo (n=853), given intra-arterially through the sheath at the end of the radial procedure. The primary outcome was the incidence of RAO as confirmed by absence of antegrade flow at one day after the transradial procedure evaluated by duplex ultrasound of the radial artery.
RESULTS


The use of nitroglycerin, as compared with placebo, reduced the risk of the primary outcome [8.3% vs. 11.7%; odds ratio, 0.62; 95% confidence interval (CI), 0.44-0.87; P=0.006]. From a multivariable analysis, duration of hemostasis was a predictor of RAO (odds ratio, (odds ratio, 3.11; 95% CI, 1.66 to 5.82; P<0.001). There were no significant differences between the groups with respect to the sheath size (P=0.311), number of puncture attempts (P=0.941), duration of hemostasis (P=0.379) and procedural time (P=0.095).
CONCLUSION


The administration of nitroglycerin at the end of a transradial catheterization, reduced the incidence of RAO, examined 1 day after the radial procedure by ultrasound. Postprocedural/prehemostasis pharmacologic regimens may represent a novel target for further investigation to reduce RAO.",2015,"There were no significant differences between the groups with respect to the sheath size (P=0.311), number of puncture attempts (P=0.941), duration of hemostasis (P=0.379) and procedural time (P=0.095).
","['enrolled 1,706 patients who underwent transradial catheterization in three experienced radial centers']","['500 µg nitroglycerin', 'placebo', 'nitroglycerin']","['number of puncture attempts', 'duration of hemostasis', 'sheath size', 'radial artery occlusion (RAO', 'incidence of RAO as confirmed by absence of antegrade flow', 'procedural time', 'duplex ultrasound of the radial artery', 'incidence of RAO', 'radial artery occlusion']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0677513', 'cui_str': 'Antegrade (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242845', 'cui_str': 'Ultrasonography, Doppler, Duplex'}]",1706.0,0.558375,"There were no significant differences between the groups with respect to the sheath size (P=0.311), number of puncture attempts (P=0.941), duration of hemostasis (P=0.379) and procedural time (P=0.095).
","[{'ForeName': 'Surya', 'Initials': 'S', 'LastName': 'Dharma', 'Affiliation': 'Department of Cardiology and Vascular Medicine, Faculty of Medicine, University of Indonesia, National Cardiovascular Center Harapan Kita Jakarta, Indonesia.'}, {'ForeName': 'Sasko', 'Initials': 'S', 'LastName': 'Kedev', 'Affiliation': ''}, {'ForeName': 'Tejas', 'Initials': 'T', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Kiemeneij', 'Affiliation': ''}, {'ForeName': 'Ian C', 'Initials': 'IC', 'LastName': 'Gilchrist', 'Affiliation': ''}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.25661']
1270,32408153,Safety and feasibility of various fasting-mimicking diets among people with multiple sclerosis.,"BACKGROUND


Fasting-mimicking diets have shown promise in experimental autoimmune encephalitis and are currently being investigated among people with multiple sclerosis (MS). Ensuring adherence to diet changes is critical to determining the efficacy of such interventions.
OBJECTIVE


Our primary aim was to evaluate the safety and feasibility of several fasting-mimicking diets and investigate whether various levels of clinical support improve diet adherence among people with MS. Secondarily, this study evaluated the impact of fasting-mimicking diets on weight and patient-reported outcomes (PROs).
METHODS


We conducted three pilot studies (two randomized controlled for 6 months; one randomized with transition to single arm) restricting either the amount or timing of calorie intake over 24 or 48 weeks. Interventions included calorie restriction (daily or intermittently) or time-restricted feeding. Adherence measures varied across studies but were collected at study visits along with weight and PRO data.
RESULTS


A total of 90 participants enrolled; 70 completed the studies, with no serious adverse events reported. Overall adherence to the calorie restriction diets was poor. When participants were tasked with maintaining a diet in a pragmatic setting, neither previously completed intense clinical support and education, nor weekly electronic communication throughout the diet period appeared to improve diet adherence. Participants who were able to adhere to a calorie restriction diet predictably lost weight. In contrast to calorie restriction, adherence to a time-restricted feeding (TRF) diet was relatively good. No statistically significant changes in PROs were observed in an intention-to-treat analysis.
CONCLUSION


The role diet may play in clinical outcomes in MS remains unknown, as class I evidence is lacking. Diet adherence remains a primary barrier to the feasible conduct of large, randomized controlled diet trials. Strict adherence to a TRF dietary change may be more feasible than calorie restriction and should be considered in future fasting-mimicking diet trials. ClinicalTrials.gov Registry:A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis - NCT02647502. A Pragmatic Trial of Dietary Programs in People with Multiple Sclerosis (MS) - NCT02846558.",2020,"No statistically significant changes in PROs were observed in an intention-to-treat analysis.
","['people with MS', 'Participants who were able to adhere to a calorie restriction diet predictably lost weight', 'people with multiple sclerosis (MS', 'people with multiple sclerosis', 'People with Multiple Sclerosis (MS) - NCT02846558', 'A total of 90 participants enrolled; 70 completed the studies, with no serious adverse events reported']","['Dietary Programs', 'various fasting-mimicking diets', 'Intermittent Calorie Restriction', 'several fasting-mimicking diets']","['PROs', 'calorie restriction (daily or intermittently) or time-restricted feeding', 'Overall adherence']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]","[{'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",90.0,0.0618671,"No statistically significant changes in PROs were observed in an intention-to-treat analysis.
","[{'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Roman', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United State. Electronic address: sroman6@jhmi.edu.'}, {'ForeName': 'K C', 'Initials': 'KC', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United State.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Beier', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine, Baltimore, MD, United State.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Mowry', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United State.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102149']
1271,30772898,Person-Centered Sexual Expression: Determining Preferences of Future Nursing Home Residents.,"BACKGROUND AND OBJECTIVES


Approaches to sexual expression in nursing homes are often devoid of person-centered components, such as resident choice. Little is known about residents' preferences for sexual and intimate expression across different situations. To evaluate future resident preferences, a convenience sample of 389 midlife and older adults in the United States were assessed for their perceptions of appropriateness of sexual and intimate activity among couples in nursing homes, given certain situational factors (e.g., cognitive impairment, relationship status, assent behaviors).
RESEARCH DESIGN AND METHODS


A randomized experimental vignette design was implemented to determine situational factors that influence future resident preferences for sexual expression in nursing homes. Data were analyzed via multilevel modeling, allowing for multiple vignette ratings to be nested among respondents.
RESULTS


Behavioral indications of assent, level of intimacy between the couple, and age of respondent affected respondents' ratings of appropriateness of sexual and intimate activities. Also, cognition and relationship levels interacted for more nuanced effects on activity appropriateness.
DISCUSSION AND IMPLICATIONS


Future resident preferences are often incongruent with attitudes and common practices for approaching sexual expression in nursing home settings. This marks a unique opportunity for person-centered policy development and implementation in the realm of sexual expression.",2020,"RESULTS


Behavioral indications of assent, level of intimacy between the couple, and age of respondent affected respondents' ratings of appropriateness of sexual and intimate activities.","['nursing homes', 'Future Nursing Home Residents', '389 midlife and older adults in the United States were assessed for their perceptions of appropriateness of sexual and intimate activity among couples in nursing homes, given certain situational factors (e.g., cognitive impairment, relationship status, assent behaviors']",[],[],"[{'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C4517752', 'cui_str': '389 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205423', 'cui_str': 'Certainty (attribute)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",[],[],,0.0293967,"RESULTS


Behavioral indications of assent, level of intimacy between the couple, and age of respondent affected respondents' ratings of appropriateness of sexual and intimate activities.","[{'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Syme', 'Affiliation': 'Center on Aging, Kansas State University, Manhattan.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Johnson', 'Affiliation': 'Center for Research Methods and Data Analysis, University of Kansas, Lawrence.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Fager', 'Affiliation': 'Center for Research Methods and Data Analysis, University of Kansas, Lawrence.'}]",The Gerontologist,['10.1093/geront/gnz016']
1272,31494019,Evaluation of a technology assisted physical activity intervention among hospitalised patients: A randomised study.,"BACKGROUND


Physical inactivity is common during hospitalisation and poses a threat to functional capacity and independency in the elderly.
AIM


We aimed to assess the effect of physical activity measurements with visual feedback about time spent in various activities on the average daily time spent out of bed during hospitalisation.
METHODS


We recorded physical activity during hospitalisation by accelerometers and compared the effect of the visual feedback (intervention) with no feedback (control) on time spent out of bed. Patients admitted to the pulmonary ward were invited and assigned to intervention with feedback or control with no feedback in 6 alternating waves of approximately 18 patients each. The order of feedback/no feedback was randomised at the outset of the study. The visual feedback intervention group was provided with visual feedback of the daily time spent in bed, sitting, standing, and walking. The control group did not receive feedback.
RESULTS


93 patients completed the study with a median length of stay of 5 days. Across all patients there were no statistically significant group differences in daily time out of bed; however, patients with independent mobility spent 51 minutes (95% CI 0 to 102; P = .049) more out of bed when provided with visual feedback compared to no feedback.
CONCLUSIONS


A simple technology assisted physical activity intervention with visual feedback to encourage mobility was not effective at increasing time spent out of bed among hospitalised patients. With feedback, a subgroup of patients with independent walking abilities increased time out of bed and may benefit from this type of intervention.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT01945749.",2019,A simple technology assisted physical activity intervention with visual feedback to encourage mobility was not effective at increasing time spent out of bed among hospitalised patients.,"['hospitalised patients', 'Patients admitted to the pulmonary ward', '93 patients completed the study with a median length of stay of 5 days']","['visual feedback (intervention) with no feedback (control', 'visual feedback intervention', 'technology assisted physical activity intervention', 'intervention with feedback or control with no feedback']",['daily time out of bed'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0004916', 'cui_str': 'Beds'}]",93.0,0.0776366,A simple technology assisted physical activity intervention with visual feedback to encourage mobility was not effective at increasing time spent out of bed among hospitalised patients.,"[{'ForeName': 'Christian Have', 'Initials': 'CH', 'LastName': 'Dall', 'Affiliation': 'Department of Physical and Occupational Therapy, Bispebjerg Frederiksberg University Hospital, Copenhagen and University of Copenhagen, Denmark; Department of Cardiology, Bispebjerg Frederiksberg University Hospital, Copenhagen and University of Copenhagen, Denmark; The Parker Institute, Bispebjerg Frederiksberg University Hospital, Copenhagen and University of Copenhagen, Denmark. Electronic address: christian.have.dall@regionh.dk.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Andersen', 'Affiliation': 'Department of Physical and Occupational Therapy, Bispebjerg Frederiksberg University Hospital, Copenhagen and University of Copenhagen, Denmark.'}, {'ForeName': 'Tina Myung', 'Initials': 'TM', 'LastName': 'Povlsen', 'Affiliation': 'VihTek, Rigshospitalet, Valdemar Hansens Vej 2, 2600 Glostrup, Denmark.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Henriksen', 'Affiliation': 'Department of Physical and Occupational Therapy, Bispebjerg Frederiksberg University Hospital, Copenhagen and University of Copenhagen, Denmark; The Parker Institute, Bispebjerg Frederiksberg University Hospital, Copenhagen and University of Copenhagen, Denmark.'}]",European journal of internal medicine,['10.1016/j.ejim.2019.08.019']
1273,30765264,"Laparoscopic versus open adhesiolysis for adhesive small bowel obstruction (LASSO): an international, multicentre, randomised, open-label trial.","BACKGROUND


Although laparoscopic adhesiolysis for adhesive small bowel obstruction is being done more frequently, it is not widely accepted due to the lack of supporting evidence of its superiority over an open approach and concerns regarding its benefits. We aimed to investigate whether laparoscopic adhesiolysis was a superior treatment for adhesive small bowel obstruction compared with an open approach in terms of length of postoperative hospital stay and morbidity.
METHODS


In this international, multicentre, parallel, open-label trial, we randomly assigned patients (1:1) aged 18-95 years who had adhesive small bowel obstruction that had not resolved with conservative management to have either open or laparoscopic adhesiolysis. The study was done in five academic university hospitals and three community (central) hospitals in two countries (Finland [n=3 academic university hospitals; n=3 community hospitals] and Italy [n=2 academic university hospitals]). We included only patients with high likelihood of a single adhesive band in the trial; additionally, patients who had an anaesthesiological contraindication, were pregnant, living in institutionalised care, or who had a hospital stay of more than 1 week before the surgical consultation were excluded from the trial. The randomisation sequence was generated using block randomisation, with randomly varied block sizes and stratified according to centre. The primary outcome was postoperative length of hospital stay assessed at time of discharge in the modified intention-to-treat population.
FINDINGS


Between July 18, 2013, and April 9, 2018, 566 patients were assessed for eligibility, of whom 104 patients were randomly assigned to the open surgery group (n=51) or to the laparoscopy group (n=53). Of these patients, 100 were included in the modified intention-to-treat analyses (49 in the open surgery group; 51 in the laparoscopy group). The postoperative length of hospital stay for open surgery group was on average 1·3 days longer than that in the laparoscopy group (geometric mean 5·5 days [range 2-19] vs 4·2 days [range 1 -20]; ratio of geometric means 1·31 [95% CI 1·06-1·61]; p=0·013). 21 (43%) patients in the open surgery group and 16 (31%) patients in the laparoscopy group had postoperative complications (Clavien-Dindo any grade) within 30 days (odds ratio 0·61 [95% CI 0·27-1·38]; p=0·23). One patient died in each group within 30 days.
INTERPRETATION


Laparoscopic adhesiolysis provides quicker recovery in selected patients with adhesive small bowel obstruction than open adhesiolysis.
FUNDING


Vatsatautien Tutkimussäätiö Foundation, Mary and Georg Ehrnrooth's Foundation, Martti I Turunen Foundation, and governmental (Finland) competitive research funds (EVO/VTR/TYH).",2019,The postoperative length of hospital stay for open surgery group was on average 1·3 days longer than that in the laparoscopy group (geometric mean 5·5 days [range 2-19] vs 4·2 days,"['selected patients with adhesive small bowel obstruction than open adhesiolysis', 'Of these patients, 100 were included in the modified intention-to-treat analyses (49 in the open surgery group; 51 in the laparoscopy group', 'patients with high likelihood of a single adhesive band in the trial; additionally, patients who had an anaesthesiological contraindication, were pregnant, living in institutionalised care, or who had a hospital stay of more than 1 week before the surgical consultation were excluded from the trial', '0·61', 'adhesive small bowel obstruction (LASSO', 'Between July 18, 2013, and April 9, 2018, 566 patients were assessed for eligibility, of whom 104 patients', 'randomly assigned patients (1:1) aged 18-95 years who had adhesive small bowel obstruction that had not resolved with conservative management to have either open or laparoscopic adhesiolysis', 'five academic university hospitals and three community (central) hospitals in two countries (Finland [n=3 academic university hospitals; n=3 community hospitals] and Italy [n=2 academic university hospitals']","['laparoscopic adhesiolysis', 'laparoscopy', 'Laparoscopic versus open adhesiolysis']","['postoperative complications', 'postoperative length of hospital stay', 'postoperative hospital stay and morbidity', 'postoperative length of hospital stay assessed at time of discharge in the modified intention-to-treat population']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C0235329', 'cui_str': 'Small bowel obstruction (disorder)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0012826', 'cui_str': 'Lysis of adhesions (procedure)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0348025', 'cui_str': 'Open approach - access (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C1301624', 'cui_str': 'Contraindications'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3714811', 'cui_str': 'Resolved (qualifier value)'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C0198539', 'cui_str': 'Laparoscopic adhesiolysis'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C0198539', 'cui_str': 'Laparoscopic adhesiolysis'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0012826', 'cui_str': 'Lysis of adhesions (procedure)'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",566.0,0.224955,The postoperative length of hospital stay for open surgery group was on average 1·3 days longer than that in the laparoscopy group (geometric mean 5·5 days [range 2-19] vs 4·2 days,"[{'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Sallinen', 'Affiliation': 'Department of Abdominal Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Department of Transplantation and Liver Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland. Electronic address: ville.sallinen@helsinki.fi.'}, {'ForeName': 'Salomone', 'Initials': 'S', 'LastName': 'Di Saverio', 'Affiliation': ""Maggiore Hospital Bologna, Bologna, Italy; Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge Biomedical Campus, Cambridge, UK.""}, {'ForeName': 'Eija', 'Initials': 'E', 'LastName': 'Haukijärvi', 'Affiliation': 'Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Risto', 'Initials': 'R', 'LastName': 'Juusela', 'Affiliation': 'Vaasa Central Hospital, Vaasa, Finland.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Wikström', 'Affiliation': 'Peijas Hospital, Vantaa, Finland.'}, {'ForeName': 'Vesa', 'Initials': 'V', 'LastName': 'Koivukangas', 'Affiliation': 'Department of Surgery, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Catena', 'Affiliation': 'Emergency Surgery Department, Parma University Hospital, Parma, Italy.'}, {'ForeName': 'Berndt', 'Initials': 'B', 'LastName': 'Enholm', 'Affiliation': 'Department of Surgery, Päijät-Häme Central Hospital, Lahti, Finland.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Birindelli', 'Affiliation': 'Department of Surgery, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Leppäniemi', 'Affiliation': 'Department of Abdominal Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Panu', 'Initials': 'P', 'LastName': 'Mentula', 'Affiliation': 'Department of Abdominal Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30016-0']
1274,30765242,"Protection against varicella with two doses of combined measles-mumps-rubella-varicella vaccine or one dose of monovalent varicella vaccine: 10-year follow-up of a phase 3 multicentre, observer-blind, randomised, controlled trial.","BACKGROUND


The duration of protection provided by varicella vaccines is unclear. We assessed the 10-year vaccine efficacy of two doses of a combined measles-mumps-rubella-varicella vaccine (MMRV), one live attenuated varicella vaccine (V) dose given after one measles-mumps-rubella vaccine (MMR) dose (MMR + V), versus two MMR doses (control vaccine) for the prevention of confirmed varicella.
METHODS


This was a phase 3b follow-up of an observer-blinded, randomised, controlled trial. In phase a, children aged 12-22 months (at first vaccination) from Czech Republic (Czechia), Greece, Italy, Lithuania, Norway, Poland, Romania, Russia, Slovakia, and Sweden were randomly assigned by computer-generated randomisation list (3:3:1) to receive two doses of MMRV, one dose of MMR and one dose of varicella vaccine, or two doses of MMR, 42 days apart. Varicella cases were confirmed by detection of viral DNA, or epidemiological link and clinical assessment, by an independent data monitoring committee; disease severity was based on a modified Vázquez scale. Hazard ratios for MMRV and MMR + V versus MMR estimated in the per-protocol cohort using a Cox proportional hazards regression model were used to calculate vaccine efficacy and 95% CI. Serious adverse events were recorded throughout the study in all vaccinated children. Study objectives were secondary and descriptive. The trial is registered at ClinicalTrials.gov, number NCT00226499.
FINDINGS


Between Sept 1, 2005, and May 10, 2006, 5803 children (mean age 14·2 months, SD 2·5) were vaccinated. The per-protocol cohort included 2279 children from the MMRV group, 2266 from the MMR + V group, and 744 from the MMR group. From baseline to a median follow-up of 9·8 years, 76 (3%) children in the MMRV group, 469 (21%) in the MMR + V group, and 352 (47%) in the MMR group had varicella. Vaccine efficacy against all varicella was 95·4% (95% CI 94·0-96·4) for MMRV and 67·2% (62·3-71·5) for MMR + V; vaccine efficacy against moderate or severe varicella was 99·1% (97·9-99·6) for MMRV and 89·5% (86·1-92·1) for MMR + V. During phase b, serious adverse events were reported by 290 (15%) of 1961 children in the MMRV group, 317 (16%) of 1978 in the MMR + V group, and 93 (15%) of 641 in the MMR group. There were no treatment-related deaths.
INTERPRETATION


The 10-years vaccine efficacy observed, suggests that a two-dose schedule of varicella vaccine provided optimum long-term protection for the prevention of varicella by offering individual protection against all severities of disease and leading to a potential reduction in transmission, as observed in the US experience with universal mass vaccination.
FUNDING


GlaxoSmithKline Biologicals.",2019,Vaccine efficacy against all varicella was 95·4% (95% CI 94·0-96·4) for MMRV and 67·2% (62·3-71·5) for MMR + V; vaccine efficacy against moderate or severe varicella was 99·1% (97·9-99·6) for MMRV and 89·5% (86·1-92·1) for MMR + V.,"['5803 children (mean age 14·2 months, SD 2·5) were vaccinated', '2279 children from the MMRV group, 2266 from the MMR\u2008+\u2008V group, and 744 from the MMR group', 'children aged 12-22 months (at first vaccination) from Czech Republic (Czechia), Greece, Italy, Lithuania, Norway, Poland, Romania, Russia, Slovakia, and Sweden']","['combined measles-mumps-rubella-varicella vaccine', 'monovalent varicella vaccine', 'combined measles-mumps-rubella-varicella vaccine (MMRV), one live attenuated varicella vaccine (V) dose given after one measles-mumps-rubella vaccine (MMR) dose (MMR\u2008+\u2008V), versus two MMR doses (control vaccine', 'MMRV, one dose of MMR and one dose of varicella vaccine']","['vaccine efficacy against moderate or severe varicella', '10-year vaccine efficacy', 'Hazard ratios for MMRV and MMR\u2008+\u2008V versus MMR', 'Vaccine efficacy', 'serious adverse events', 'Serious adverse events']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0206578', 'cui_str': 'Czech Republic'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0023879', 'cui_str': 'Lithuania'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0035826', 'cui_str': 'Romania'}, {'cui': 'C0035970', 'cui_str': 'Russian Federation (Europe)'}, {'cui': 'C0206579', 'cui_str': 'Slovak Republic'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0035920', 'cui_str': 'Measles, German'}, {'cui': 'C0078048', 'cui_str': 'Varicella Vaccine'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0025007', 'cui_str': 'Rubeola'}, {'cui': 'C0035923', 'cui_str': 'rubella, live attenuated'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0008049', 'cui_str': 'Varicella'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2279.0,0.272594,Vaccine efficacy against all varicella was 95·4% (95% CI 94·0-96·4) for MMRV and 67·2% (62·3-71·5) for MMR + V; vaccine efficacy against moderate or severe varicella was 99·1% (97·9-99·6) for MMRV and 89·5% (86·1-92·1) for MMR + V.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Povey', 'Affiliation': 'GlaxoSmithKline, Wavre, Belgium. Electronic address: michael.x.povey@gsk.com.'}, {'ForeName': 'Ouzama', 'Initials': 'O', 'LastName': 'Henry', 'Affiliation': 'GlaxoSmithKline, Rockville, MD, USA.'}, {'ForeName': 'Marianne A', 'Initials': 'MA', 'LastName': 'Riise Bergsaker', 'Affiliation': 'Division of Health Services, Department of Global Health, Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Chlibek', 'Affiliation': 'University of Defence, Faculty of Military Health Sciences, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Esposito', 'Affiliation': 'Pediatric Clinic, Department of Surgical and Biomedical Sciences, Università degli Studi di Perugia, Perugia, Italy.'}, {'ForeName': 'Carl-Erik', 'Initials': 'CE', 'LastName': 'Flodmark', 'Affiliation': 'Department of Paediatrics, Skånes University Hospital, Malmo, Sweden.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Gothefors', 'Affiliation': 'The Public Health Agency of Sweden and Department of Clinical Sciences/Pediatrics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Sorin', 'Initials': 'S', 'LastName': 'Man', 'Affiliation': '3rd Pediatric Department, Iuliu Hațieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Sven-Arne', 'Initials': 'SA', 'LastName': 'Silfverdal', 'Affiliation': 'Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Mária', 'Initials': 'M', 'LastName': 'Štefkovičová', 'Affiliation': 'Faculty of Health Care, Alexander Dubček University of Trenčín, Trenčín, Slovakia.'}, {'ForeName': 'Vytautas', 'Initials': 'V', 'LastName': 'Usonis', 'Affiliation': ""Clinic of Children's Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.""}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Wysocki', 'Affiliation': 'Department of Preventive Medicine, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gillard', 'Affiliation': 'GlaxoSmithKline, Wavre, Belgium.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Prymula', 'Affiliation': 'University of Defence, Faculty of Military Health Sciences, Hradec Kralove, Czech Republic; Charles University, Faculty of Medicine in Hradec Kralove, Department of Social Medicine, Hradec Kralove, Czech Republic.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30716-3']
1275,30229989,Prevalence and Impact of De Novo Donor-Specific Antibodies During a Multicenter Immunosuppression Withdrawal Trial in Adult Liver Transplant Recipients.,"The development of human leukocyte antigen (HLA) donor-specific antibody/antibodies (DSA) is not well described in liver transplant (LT) patients undergoing immunosuppression (IS) withdrawal protocols despite the allograft risk associated with de novo DSA (dnDSA). We analyzed the development of dnDSA in 69 LT patients who received calcineurin inhibitor monotherapy and were enrolled in the ITN030ST study. Of these 69 patients, 40 stable patients were randomized to IS maintenance (n = 9) or IS minimization (n = 31). Nine of the 31 IS minimization patients achieved complete withdrawal and were free of IS. Among patients who achieved stable IS monotherapy 1 year after transplantation, the prevalence of dnDSA was 18.8%. Acute rejections and the biopsy-proven findings disqualifying patients from IS withdrawal attempt were factors associated with dnDSA development (P = 0.011 and P = 0.041, respectively). Among randomized patients, dnDSA prevalence was 51.7% after IS minimization and 66.7% in IS-free patients. dnDSA prevalence in patients on IS maintenance was 44.4%. dnDSA development during IS minimization was a risk factor for acute rejection (P = 0.015). The majority of dnDSA were against HLA-DQ antigens (78.7%). Conclusion. During the first year following transplantation, acute rejections increase the risk of developing dnDSA, so dnDSA positivity should be considered for IS withdrawal eligibility; during IS minimization, dnDSA development was associated with acute rejection, which prevented further IS withdrawal attempts.",2019,dnDSA development during IS minimization was a risk factor for acute rejection (P = 0.015).,"['Adult Liver Transplant Recipients', 'patients on', '69 LT patients who received', 'liver transplant (LT) patients undergoing immunosuppression (IS) withdrawal protocols despite the allograft risk associated with de novo DSA (dnDSA', '69 patients, 40 stable patients']",['calcineurin inhibitor monotherapy'],"['dnDSA prevalence', 'complete withdrawal', 'Prevalence and Impact of De Novo Donor-Specific Antibodies', 'Acute rejections']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3811922', 'cui_str': 'Transplanted liver present (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]","[{'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody (substance)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}]",69.0,0.0330249,dnDSA development during IS minimization was a risk factor for acute rejection (P = 0.015).,"[{'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Jucaud', 'Affiliation': 'Terasaki Research Institute, Los Angeles, CA.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Shaked', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'DesMarais', 'Affiliation': 'Immune Tolerance Network, San Francisco, CA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sayre', 'Affiliation': 'Immune Tolerance Network, San Francisco, CA.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Levitsky', 'Affiliation': 'Northwestern University, Chicago, IL.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Everly', 'Affiliation': 'Terasaki Research Institute, Los Angeles, CA.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30281']
1276,30732940,"Dolutegravir versus ritonavir-boosted lopinavir both with dual nucleoside reverse transcriptase inhibitor therapy in adults with HIV-1 infection in whom first-line therapy has failed (DAWNING): an open-label, non-inferiority, phase 3b trial.","BACKGROUND


Doubts exist regarding optimal second-line treatment options for HIV-1-infected patients in resource-limited settings. We assessed safety and efficacy of dolutegravir compared with ritonavir-boosted lopinavir, plus two nucleoside reverse transcriptase inhibitors (NRTIs) in adults in whom previous first-line antiretroviral therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI) plus two NRTIs has failed.
METHODS


DAWNING is a phase 3b, open-label, parallel-group, non-inferiority, active-controlled trial done at 58 sites in 13 countries. Eligible adults were aged at least 18 years and, during at least 6 months of treatment with a first-line treatment containing an NNRTI and two NRTIs, had virological failure (confirmed HIV-1 RNA ≥400 copies per mL). Participants were randomly assigned by a central randomisation system to receive oral dolutegravir (50 mg once daily) or ritonavir-boosted lopinavir (800 mg lopinavir plus 200 mg ritonavir once daily or 400 mg plus 100 mg twice daily), plus two investigator-selected NRTIs (at least one fully active based on resistance testing at screening). The primary outcome was the proportion of participants achieving viral suppression (defined as plasma HIV-1 RNA <50 copies per mL) at week 48 using the snapshot algorithm and a non-inferiority margin of -12%. The primary analysis was done in an intention-to-treat-exposed (ITT-E) population of participants who received at least one dose of study medication, according to original group assignment. Safety was analysed in all participants who received at least one dose of study drug, according to which drug was received. The study was registered at ClinicalTrials.gov, number NCT02227238, and viiv-studyregister.com, number 200304.
FINDINGS


Between Dec 11, 2014, and June 27, 2016, 968 adults were screened and 627 were randomly assigned to the dolutegravir group (n=312) or the ritonavir-boosted lopinavir group (n=315). Three patients in the ritonavir-boosted lopinavir group did not receive study medication and so 624 were included in the ITT-E population. At week 48, 261 (84%) of 312 participants in the dolutegravir group achieved viral suppression compared with 219 (70%) of 312 in the ritonavir-boosted lopinavir group (adjusted difference 13·8%; 95% CI 7·3-20·3). Non-inferiority was achieved on the basis of the 95% CI of the adjusted treatment difference having a lower bound greater than -12% (prespecified non-inferiority margin). Because the lower bound of the 95% CI is greater than zero (7·3%), superiority of dolutegravir was also concluded (p<0·0001). The safety profile for dolutegravir was favourable compared with that of ritonavir-boosted lopinavir. More grade 2-4 drug-related adverse events occurred with ritonavir-boosted lopinavir than dolutegravir (44 [14%] of 310 with ritonavir-boosted lopinavir vs 11 [4%] of 314 with dolutegravir), mainly driven by gastrointestinal disorders.
INTERPRETATION


When administered with two NRTIs, dolutegravir was superior to ritonavir-boosted lopinavir at 48 weeks and can be considered a suitable option for second-line treatment.
FUNDING


ViiV Healthcare.",2019,"At week 48, 261 (84%) of 312 participants in the dolutegravir group achieved viral suppression compared with 219 (70%) of 312 in the ritonavir-boosted lopinavir group (adjusted difference 13·8%; 95% CI 7·3-20·3).","['adults in whom previous first-line antiretroviral therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI) plus two NRTIs has failed', 'HIV-1-infected patients in resource-limited settings', '968 adults were screened and 627 were randomly assigned to the dolutegravir group (n=312) or the', 'adults with HIV-1 infection in whom first-line therapy', 'Between Dec 11, 2014, and June 27, 2016', 'Eligible adults were aged at least 18 years and, during at least 6 months of treatment with a first-line treatment containing an NNRTI and two NRTIs, had virological failure (confirmed HIV-1 RNA ≥400 copies per mL']","['oral dolutegravir', 'ritonavir-boosted lopinavir (800 mg lopinavir plus 200 mg ritonavir once daily or 400 mg plus 100 mg twice daily), plus two investigator-selected NRTIs (at least one fully active based on resistance testing at screening', 'ritonavir-boosted lopinavir', 'ritonavir-boosted lopinavir, plus two nucleoside reverse transcriptase inhibitors (NRTIs', 'Dolutegravir versus ritonavir-boosted lopinavir both with dual nucleoside reverse transcriptase inhibitor therapy', 'dolutegravir']","['viral suppression', 'adverse events', 'superiority of dolutegravir', 'proportion of participants achieving viral suppression', 'Safety', 'safety profile for dolutegravir']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C3541376', 'cui_str': 'Non-nucleoside reverse transcriptase inhibitors'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0028621', 'cui_str': 'Nucleosides'}, {'cui': 'C4521921', 'cui_str': 'Reverse transcriptase inhibitor'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",968.0,0.462844,"At week 48, 261 (84%) of 312 participants in the dolutegravir group achieved viral suppression compared with 219 (70%) of 312 in the ritonavir-boosted lopinavir group (adjusted difference 13·8%; 95% CI 7·3-20·3).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Aboud', 'Affiliation': 'ViiV Healthcare, Brentford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kaplan', 'Affiliation': 'Desmond Tutu HIV Foundation, Cape Town, South Africa.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Lombaard', 'Affiliation': 'Josha Research, Bloemfontein, South Africa.'}, {'ForeName': 'Fujie', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Hidalgo', 'Affiliation': 'Vía Libre, Lima, Peru.'}, {'ForeName': 'Elmira', 'Initials': 'E', 'LastName': 'Mamedova', 'Affiliation': 'Kiev City AIDS Centre, Kiev, Ukraine.'}, {'ForeName': 'Marcelo H', 'Initials': 'MH', 'LastName': 'Losso', 'Affiliation': 'Hospital JM Ramos Mejia, Buenos Aires, Argentina.'}, {'ForeName': 'Ploenchan', 'Initials': 'P', 'LastName': 'Chetchotisakd', 'Affiliation': 'Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Brites', 'Affiliation': 'Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Sievers', 'Affiliation': 'ViiV Healthcare, Brentford, UK. Electronic address: jorg.x.sievers@viivhealthcare.com.'}, {'ForeName': 'Dannae', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'ViiV Healthcare, Abbotsford, Australia.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Hopking', 'Affiliation': 'GlaxoSmithKline, Stockley Park, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Maria Claudia', 'Initials': 'MC', 'LastName': 'Nascimento', 'Affiliation': 'ViiV Healthcare, Brentford, UK.'}, {'ForeName': 'Yogesh', 'Initials': 'Y', 'LastName': 'Punekar', 'Affiliation': 'ViiV Healthcare, Brentford, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gartland', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30036-2']
1277,31690491,The impact of exercise modality and menstrual cycle phase on circulating cardiac troponin T.,"OBJECTIVES


It is unclear whether exercise modality (moderate-intensity continuous [MCE]; high-intensity interval [HIE]) and menstrual cycle phase (follicular [FP]; luteal [LP]), individually or in combination, mediate the commonly observed exercise-induced elevation in cardiac troponin T (cTnT). This study examines cTnT responses to MCE and HIE during both the FP and LP.
DESIGN


Randomised crossover study.
METHODS


Seventeen healthy, eumenorrheic women completed four trials including MCE (60% VO 2max  steady-state cycling until 300kJ) and work-equivalent HIE (repeated 4-min cycling at 90% VO 2max  interspersed with 3-min rest) during both the FP and LP. The FP and LP were verified based on ovarian hormones. Serum cTnT was assessed using a high-sensitivity assay before, immediately after, and 1 (1HR), 3 (3HR) and 4 (4HR) hours after exercise. cTnT values were corrected for plasma volume changes.
RESULTS


cTnT was significantly elevated (p<0.05) post-exercise in both MCE (at 3HR and 4HR) and HIE (at 1HR, 3HR and 4HR). No statistically significant difference (p>0.05) in peak post-exercise cTnT, which mostly occurred at 3HR, was seen among the four trials (median [range], ngl -1 : 5.2 [1.7-18.1] after MCE during FP; 4.8 [1.7-24.9] after MCE during LP, 8.2 [3.9-24.8] after HIE during FP and 6.9 [1.7-23.1] after HIE during LP).
CONCLUSIONS


A single 300kJ bout of both MCE or HIE resulted in a significant post-exercise increase in cTnT, with no differences in peak cTnT response between menstrual cycle phases or between exercise modes, but the cTnT elevation occurs slightly earlier after HIE.",2020,"A single 300kJ bout of both MCE or HIE resulted in a significant post-exercise increase in cTnT, with no differences in peak cTnT","['Seventeen healthy, eumenorrheic women completed four trials including']","['MCE (60% VO 2max  steady-state cycling until 300kJ) and work-equivalent HIE (repeated 4-min cycling at 90% VO 2max  interspersed with 3-min rest', 'cTnT']","['FP and LP', 'peak cTnT', 'cardiac troponin T (cTnT']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0256930', 'cui_str': 'mesochlorin e6 monoethylenediamine'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C3538889', 'cui_str': 'Cardiac troponin T (substance)'}]",17.0,0.0583995,"A single 300kJ bout of both MCE or HIE resulted in a significant post-exercise increase in cTnT, with no differences in peak cTnT","[{'ForeName': 'Jinlei', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': 'School of Health Sciences and Sports, Macao Polytechnic Institute, Macao.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Physical Education College, Hebei Normal University, China; Hebei Provincial Key Lab of Measurement and Evaluation in Human Movement and Bio-Information, China. Electronic address: zhanghaifeng@hebtu.edu.cn.'}, {'ForeName': 'Zhaowei', 'Initials': 'Z', 'LastName': 'Kong', 'Affiliation': 'Faculty of Education, University of Macau, Macao.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Physical Education College, Hebei Normal University, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Physical Education College, Hebei Normal University, China.'}, {'ForeName': 'Qingde', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'School of Health Sciences and Sports, Macao Polytechnic Institute, Macao.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'George', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, UK.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2019.10.003']
1278,32407786,Study To Reduce Infection Prior to Elective Cesarean Deliveries (STRIPES): A randomized clinical trial of chlorhexidine.,"BACKGROUND


Surgical site infections after cesarean delivery are a source of maternal morbidity and usually due to skin microbial flora. Preadmission application of chlorhexidine gluconate via impregnated cloths may decrease surgical site infections by decreasing the abundance of microbial flora.
OBJECTIVE(S)


To determine if the application of chlorhexidine gluconate-impregnated cloths the night before and morning of scheduled cesarean delivery decreases the risk of surgical site infections by 6 weeks post-operatively compared to placebo cloths.
STUDY DESIGN


In this single-center, double-blind, placebo-controlled trial, patients were randomized (1:1) to receive either Sage 2% chlorhexidine cloths or Sage Comfort Bath fragrance-free cloths (placebo) to apply to 6 skin sites on the body (neck/shoulders/chest, arm pits/arms/hands, abdomen/groin, left leg/foot, right leg/foot, back/buttocks) the night before and after a shower the morning of scheduled cesarean delivery. Routine clinical and operative procedures were followed. The primary outcome was surgical site infections (superficial or deep -incisional and/or organ space-endometritis) by 6 weeks after cesarean delivery. The secondary outcomes were surgical site infections by 2 weeks and other wound-related complications by 2 and 6 weeks after cesarean delivery.
RESULTS


From April 2015 through August 2019, 1,356 patients were enrolled: 682 were assigned to the chlorhexidine group and 674 to the placebo group. The groups were similar in demographic and medical characteristics. Fourteen patients were lost to follow-up prior to cesarean delivery (10 in chlorhexidine and 4 in placebo) and 33 were lost to follow-up after cesarean delivery (10 in chlorhexidine and 23 in placebo). Among the remaining 1309 (97%), no difference was found in surgical site infections by 6 weeks between the groups (2.6% in chlorhexidine vs. 3.7% in placebo, P=0.24). There were no differences in secondary outcomes at 2 or 6 weeks, and no differences in primary outcome in a per-protocol analysis Conclusion(s): Pre-admission use of chlorhexidine gluconate cloths compared to placebo does not result in a reduction in surgical site infection after scheduled cesarean deliveries. Patients and physicians who follow the standard of care guidelines have a low risk of surgical site infections in this group of patients.",2020,Patients and physicians who follow the standard of care guidelines have a low risk of surgical site infections in this group of patients.,"['1,356 patients were enrolled: 682', 'From April 2015 through August 2019', 'Prior to Elective Cesarean Deliveries (STRIPES', 'Fourteen patients were lost to follow-up prior to cesarean delivery (10 in']","['chlorhexidine gluconate-impregnated cloths', 'chlorhexidine and 23 in placebo', 'chlorhexidine', 'Sage 2% chlorhexidine cloths or Sage Comfort Bath fragrance-free cloths (placebo', 'chlorhexidine gluconate', 'chlorhexidine and 4 in placebo', 'placebo']","['risk of surgical site infections', 'surgical site infection', 'surgical site infections (superficial or deep -incisional and/or organ space-endometritis', 'surgical site infections by 2 weeks and other wound-related complications', 'Infection', 'surgical site infections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C1532935', 'cui_str': 'Striped'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1122976', 'cui_str': 'Sage'}, {'cui': 'C0031000', 'cui_str': 'Perfume'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",1356.0,0.327365,Patients and physicians who follow the standard of care guidelines have a low risk of surgical site infections in this group of patients.,"[{'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Stone', 'Affiliation': 'New York NY Icahn School of Medicine at Mount Sinai Department of Obstetrics, Gynecology and Reproductive Sciences. Electronic address: Joanne.stone@mssm.edu.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Bianco', 'Affiliation': 'New York NY Icahn School of Medicine at Mount Sinai Department of Obstetrics, Gynecology and Reproductive Sciences.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Monro', 'Affiliation': 'New York NY Icahn School of Medicine at Mount Sinai Department of Obstetrics, Gynecology and Reproductive Sciences.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Overbey', 'Affiliation': 'New York NY Icahn School of Medicine at Mount Sinai Department of Population Health Science and Policy.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Cadet', 'Affiliation': 'New York NY Icahn School of Medicine at Mount Sinai Department of Obstetrics, Gynecology and Reproductive Sciences.'}, {'ForeName': 'Katie Hyewon', 'Initials': 'KH', 'LastName': 'Choi', 'Affiliation': 'New York NY Icahn School of Medicine at Mount Sinai Department of Population Health Science and Policy.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Pena', 'Affiliation': 'New York NY Icahn School of Medicine at Mount Sinai Department of Obstetrics, Gynecology and Reproductive Sciences.'}, {'ForeName': 'Brittany N', 'Initials': 'BN', 'LastName': 'Robles', 'Affiliation': 'New York NY Icahn School of Medicine at Mount Sinai Department of Obstetrics, Gynecology and Reproductive Sciences.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Mella', 'Affiliation': 'New York NY Icahn School of Medicine at Mount Sinai Department of Obstetrics, Gynecology and Reproductive Sciences.'}, {'ForeName': 'Kathy C', 'Initials': 'KC', 'LastName': 'Matthews', 'Affiliation': 'New York NY Icahn School of Medicine at Mount Sinai Department of Obstetrics, Gynecology and Reproductive Sciences.'}, {'ForeName': 'Stephanie H', 'Initials': 'SH', 'LastName': 'Factor', 'Affiliation': 'New York NY Icahn School of Medicine at Mount Sinai Department of Obstetrics, Gynecology and Reproductive Sciences and Department of Medicine.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.05.021']
1279,32407608,"Liver function and prognosis, and influence of sacubitril/valsartan in patients with heart failure with reduced ejection fraction.","AIMS


The prevalence of liver function abnormalities is common in patients with heart failure (HF) with reduced ejection fraction (HFrEF). We assessed the impact of liver function on prognosis and the effect of sacubitril/valsartan on measures of liver function in patients with HFrEF.
METHODS AND RESULTS


The PARADIGM-HF trial was a randomized, double-blind, active treatment-controlled trial. We included 8232 HFrEF patients with available measures of liver function, including transaminases, alkaline phosphatase (ALP) and bilirubin; the primary endpoint was a composite of HF hospitalization and cardiovascular (CV) death. At screening, 11.6% of study patients had total bilirubin above the upper limit of normal (20.5 μmol/L) and 9.2% had ALP above the upper limit of normal (123 IU/L). Although ALP and albumin were associated with an increased risk of outcomes, among conventional test of liver function, total bilirubin was the strongest predictor for the primary endpoint [hazard ratio (HR) 1.10; 95% confidence interval (CI) 1.04-1.15; P < 0.001], HF hospitalization (HR 1.14; 95% CI 1.07-1.22; P < 0.001); CV death (HR 1.07; 95% CI 1.00-1.14; P = 0.040), and all-cause death (HR 1.08; 95% CI 1.02-1.14; P = 0.009). All conventional measures of liver function were significantly improved in the sacubitril/valsartan group compared with the enalapril group after randomization (between-group reduction: total bilirubin 2.4%, 95% CI 0.7-4.2%, P = 0.007; aspartate aminotransferase 7.9%, 95% CI 6.7-9.0%, P < 0.001; alanine aminotransferase 7.7%; 95% CI 6.2-9.3%, P < 0.001; ALP 5.4%, 95% CI 4.4-6.4%, P < 0.001).
CONCLUSION


Total bilirubin was a significant and independent predictor of CV death or HF hospitalization and all-cause mortality in patients with HFrEF enrolled in PARADIGM-HF. Sacubitril/valsartan improved measures of liver function compared with enalapril.",2020,Total bilirubin was a significant and independent predictor of CV death or HF hospitalization and all-cause mortality in patients with HFrEF enrolled in PARADIGM-HF.,"['patients with HFrEF', 'patients with HFrEF enrolled in PARADIGM-HF', 'patients with heart failure with reduced ejection fraction', '8232 HFrEF patients with available measures of liver function, including transaminases, alkaline phosphatase (ALP) and bilirubin; the primary endpoint was a', 'patients with heart failure (HF) with reduced ejection fraction (HFrEF']","['enalapril', 'sacubitril/valsartan', 'Sacubitril/valsartan']","['composite of HF hospitalization and cardiovascular (CV) death', 'HF hospitalization', 'total bilirubin', 'Total bilirubin', 'CV death', 'CV death or HF hospitalization and all-cause mortality', 'liver function', 'liver function, total bilirubin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C1285893', 'cui_str': 'Measure of liver'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}]",8232.0,0.350391,Total bilirubin was a significant and independent predictor of CV death or HF hospitalization and all-cause mortality in patients with HFrEF enrolled in PARADIGM-HF.,"[{'ForeName': 'Kota', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Claggett', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Minamisawa', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Zile', 'Affiliation': 'Medical University of South Carolina and Ralph H. Johnson Department of Veterans Affairs Medical Center, Charleston, SC, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Rouleau', 'Affiliation': 'University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Swedberg', 'Affiliation': 'University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lefkowitz', 'Affiliation': 'Novartis, East Hanover, NJ, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Shi', 'Affiliation': 'Novartis, East Hanover, NJ, USA.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Zucker', 'Affiliation': ""Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}]",European journal of heart failure,['10.1002/ejhf.1853']
1280,32407710,"The effect of lactoferrin supplementation on death or major morbidity in very low birthweight infants (LIFT): a multicentre, double-blind, randomised controlled trial.","BACKGROUND


Very low birthweight or preterm infants are at increased risk of adverse outcomes including sepsis, necrotising enterocolitis, and death. We assessed whether supplementing the enteral diet of very low-birthweight infants with lactoferrin, an antimicrobial protein, reduces all-cause mortality or major morbidity.
METHODS


We did a multicentre, double-blind, pragmatic, randomised superiority trial in 14 Australian and two New Zealand neonatal intensive care units. Infants born weighing less than 1500 g and aged less than 8 days, were eligible and randomly assigned (1:1) using minimising web-based randomisation to receive once daily 200 mg/kg pasteurised bovine lactoferrin supplements or no lactoferrin supplement added to breast or formula milk until 34 weeks' post-menstrual age (or for 2 weeks, if longer), or until discharge from the study hospital if that occurred first. Designated nurses preparing the daily feeds were not masked to group assignment, but other nurses, doctors, parents, caregivers, and investigators were unaware. The primary outcome was survival to hospital discharge or major morbidity (defined as brain injury, necrotising enterocolitis, late-onset sepsis at 36 weeks' post-menstrual age, or retinopathy treated before discharge) assessed in the intention-to-treat population. Safety analyses were by treatment received. We also did a prespecified, PRISMA-compliant meta-analysis, which included this study and other relevant randomised controlled trials, to estimate more precisely the effects of lactoferrin supplementation on late-onset sepsis, necrotising enterocolitis, and survival. This trial is registered with the Australian and New Zealand Clinical Trials Registry, ACTRN12611000247976.
FINDINGS


Between June 27, 2014, and Sept 1, 2017, we recruited 1542 infants; 771 were assigned to the intervention group and 771 to the control group. One infant who had consent withdrawn before beginning lactoferrin treatment was excluded from analysis. In-hospital death or major morbidity occurred in 162 (21%) of 770 infants in the intervention group and in 170 (22%) of 771 infants in the control group (relative risk [RR] 0·95, 95% CI 0·79-1·14; p=0·60). Three suspected unexpected serious adverse reactions occurred; two in the lactoferrin group, namely unexplained late jaundice and inspissated milk syndrome, but were not attributed to the intervention and one in the control group had fatal inspissated milk syndrome. Our meta-analysis identified 13 trials completed before Feb 18, 2020, including this Article, in 5609 preterm infants. Lactoferrin supplements significantly reduced late-onset sepsis (RR 0·79, 95% CI 0·71-0·88; p<0·0001; I 2 =58%), but not necrotising enterocolitis or all-cause mortality.
INTERPRETATION


Lactoferrin supplementation did not improve death or major morbidity in this trial, but might reduce late-onset sepsis, as found in our meta-analysis of over 5000 infants. Future collaborative studies should use products with demonstrated biological activity, be large enough to detect moderate and clinically important effects reliably, and assess greater doses of lactoferrin in infants at increased risk, such as those not exclusively receiving breastmilk or infants of extremely low birthweight.
FUNDING


Australian National Health and Medical Research Council.",2020,"Lactoferrin supplements significantly reduced late-onset sepsis (RR 0·79, 95% CI 0·71-0·88; p<0·0001; I 2 =58%), but not necrotising enterocolitis or all-cause mortality.
INTERPRETATION


Lactoferrin supplementation did not improve death or major morbidity in this trial, but might reduce late-onset sepsis, as found in our meta-analysis of over 5000 infants.","['Infants born weighing less than 1500 g and aged less than 8 days, were eligible and randomly assigned (1:1) using', '14 Australian and two New Zealand neonatal intensive care units', '5609 preterm infants', 'One infant who had consent withdrawn before beginning lactoferrin treatment was excluded from analysis', '1542 infants; 771 were assigned to the intervention group and 771 to the control group', 'very low birthweight infants (LIFT', 'Between June 27, 2014, and Sept 1, 2017']","['Lactoferrin supplements', 'lactoferrin supplementation', 'lactoferrin', ""minimising web-based randomisation to receive once daily 200 mg/kg pasteurised bovine lactoferrin supplements or no lactoferrin supplement added to breast or formula milk until 34 weeks' post-menstrual age""]","['death or major morbidity', 'hospital death or major morbidity', 'fatal inspissated milk syndrome', 'unexplained late jaundice and inspissated milk syndrome', ""survival to hospital discharge or major morbidity (defined as brain injury, necrotising enterocolitis, late-onset sepsis at 36 weeks' post-menstrual age, or retinopathy treated before discharge) assessed in the intention-to-treat population"", 'late-onset sepsis', 'late-onset sepsis, necrotising enterocolitis, and survival']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}]","[{'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C1440867', 'cui_str': 'Bovine lactoferrin'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0452742', 'cui_str': 'Formula milk'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0277608', 'cui_str': 'Death in hospital'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0022346', 'cui_str': 'Jaundice'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035309', 'cui_str': 'Retinal disorder'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",5609.0,0.688179,"Lactoferrin supplements significantly reduced late-onset sepsis (RR 0·79, 95% CI 0·71-0·88; p<0·0001; I 2 =58%), but not necrotising enterocolitis or all-cause mortality.
INTERPRETATION


Lactoferrin supplementation did not improve death or major morbidity in this trial, but might reduce late-onset sepsis, as found in our meta-analysis of over 5000 infants.","[{'ForeName': 'William O', 'Initials': 'WO', 'LastName': 'Tarnow-Mordi', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia. Electronic address: william.tarnow-mordi@ctc.usyd.edu.au.'}, {'ForeName': 'Mohamed E', 'Initials': 'ME', 'LastName': 'Abdel-Latif', 'Affiliation': 'Australian National University, Canberra, ACT, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Pammi', 'Affiliation': 'Texas Medical Centre, Houston, TX, USA.'}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'Robledo', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Manzoni', 'Affiliation': 'Nuovo Ospedale Degli Infermi, Ponderano, Italy.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osborn', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Lui', 'Affiliation': 'University of New South Wales, Kensington, NSW, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Keech', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hague', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Alpana', 'Initials': 'A', 'LastName': 'Ghadge', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Javeed', 'Initials': 'J', 'LastName': 'Travadi', 'Affiliation': 'University of Newcastle, Newcastle, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Darlow', 'Affiliation': 'University of Otago, Otago, New Zealand.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Liley', 'Affiliation': 'University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Margo', 'Initials': 'M', 'LastName': 'Pritchard', 'Affiliation': 'University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Kochar', 'Affiliation': 'University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Isaacs', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Gordon', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Askie', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Cruz', 'Affiliation': 'Miracle Babies Foundation, Chipping Norton, NSW, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Schindler', 'Affiliation': 'University of New South Wales, Kensington, NSW, Australia.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Dixon', 'Affiliation': 'University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Girish', 'Initials': 'G', 'LastName': 'Deshpande', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tracy', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Schofield', 'Affiliation': 'Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Austin', 'Affiliation': 'University of Otago, Otago, New Zealand.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sinn', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'R John', 'Initials': 'RJ', 'LastName': 'Simes', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(20)30093-6']
1281,32407827,A simulation approach to measure critical safety behaviors when evaluating training methods for respirator education in healthcare workers.,"BACKGROUND


The N95 respirator is the most common safety tool used in hospitals to protect healthcare workers (HCW) from inhaling airborne particles. Focusing on HCW behavior related to respirator use is an effective route to improve HCW safety and respiratory health.
METHODS


Participants were asked to perform the donning and doffing of an N95 respirator to camera. Then they were randomized to a video alone or a reflective practice intervention. After the intervention they repeated the donning and doffing to camera. A critical safety behavior scoring tool (CSBST) was developed to compare the performance of the participants over time at pre-test, post-test and one month later for follow-up.
RESULTS


The reflective practice intervention group was found to have significantly higher scores on the CSBST at post-test and follow-up than the video alone group. In the reflective practice intervention group, the participants perceived they were better at performing the N95 donning and doffing than the experts scored them.
CONCLUSIONS


The CSBST is a tool to measure the performance of HCWs on a specific targeted safety behaviors. The addition of a reflective practice intervention may result in a measurable and sustained improvement in the safety behaviors demonstrated when using the N95 respirator.",2020,The reflective practice intervention group was found to have significantly higher scores on the CSBST at post-test and follow-up than the video alone group.,"['Participants were asked to perform the donning and doffing of an N95 respirator to camera', 'hospitals to protect healthcare workers (HCW) from inhaling airborne particles', 'healthcare workers']","['video alone or a reflective practice intervention', 'CSBST']","['safety behaviors', 'HCW safety and respiratory health']","[{'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0429406', 'cui_str': 'Pattern ERG N95'}, {'cui': 'C0035208', 'cui_str': 'Air-purifying respirator'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1321226', 'cui_str': 'Safety behavior'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C1321226', 'cui_str': 'Safety behavior'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.036832,The reflective practice intervention group was found to have significantly higher scores on the CSBST at post-test and follow-up than the video alone group.,"[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Beam', 'Affiliation': 'College of Nursing, University of Nebraska Medical Center, Omaha, Nebraska; Nebraska Biocontainment Unit, Omaha, Nebraska. Electronic address: ebeam@unmc.edu.'}, {'ForeName': 'Jocelyn J', 'Initials': 'JJ', 'LastName': 'Herstein', 'Affiliation': 'Nebraska Biocontainment Unit, Omaha, Nebraska; Department of Environmental, Agricultural, and Occupational Health, University of Nebraska Medical Center, College of Public Health, Omaha, Nebraska.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Kupzyk', 'Affiliation': 'College of Nursing, University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Shawn G', 'Initials': 'SG', 'LastName': 'Gibbs', 'Affiliation': 'Department of Environmental and Occupational Health, Indiana University School of Public Health, Bloomington, Indiana.'}]",American journal of infection control,['10.1016/j.ajic.2020.05.005']
1282,32407654,Caffeine Increases Peripheral Fatigue in Low- but not in High-Performing Cyclists.,"The influence of cyclist's performance level on caffeine-induced increases in neuromuscular fatigue after a 4-km cycling TT was investigated. Nineteen cyclists performed a 4-km cycling TT one hour after ingesting caffeine (5 mg‧kg-1) or placebo (cellulose). Changes from baseline to post-exercise in voluntary activation (VA) and potentiated 1 Hz force twitch (Qtw,pot) were used as markers of central and peripheral fatigue, respectively. Participants were classified as ""high-performing"" (HP, n=8) or ""low-performing"" (LP, n=8) in accordance with their performance in placebo trial. Compared with placebo, caffeine increased the power, the anaerobic mechanical power and the anaerobic work, reducing the time to complete the trial for both groups (p<0.05). There was a group vs. supplement and group vs. supplement vs. trial interaction for Qtw,pot, where the post-exercise reduction was higher after caffeine compared with placebo in LP (Qtw,pot=-34±17 vs. -21±11%, p=0.02) but not in HP (Qtw,pot=-22±8 vs. -23±10%, p=0.64). There was no effect of caffeine on VA, but there was a group vs. trial interaction with lower post-exercise values in LP than in HP (p=0.03). Caffeine-induced improvement on 4-km cycling TT performance seems to be at the expense of greater locomotor muscle fatigue in low- but not in high-performing cyclists. BULLET POINTS -Caffeine improves exercise performance at the expense of a greater end-exercise peripheral fatigue in low-performing athletes. -Caffeine-induced improvement on exercise performance does not affect end-exercise peripheral fatigue in high-performing athletes. -High-performing athletes seems to have augmented tolerance to central fatigue during a high-intensity time-trial.",2020,"Compared with placebo, caffeine increased the power, the anaerobic mechanical power and the anaerobic work, reducing the time to complete the trial for both groups (p<0.05).",['Nineteen cyclists'],"['High', 'caffeine', 'Caffeine', 'placebo in LP', 'caffeine (5 mg‧kg-1) or placebo (cellulose', 'placebo, caffeine']","['4-km cycling TT performance', 'Peripheral Fatigue', 'locomotor muscle fatigue', 'anaerobic mechanical power and the anaerobic work', 'neuromuscular fatigue', 'exercise performance']","[{'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0234116', 'cui_str': 'Neuromuscular fatigue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",19.0,0.100991,"Compared with placebo, caffeine increased the power, the anaerobic mechanical power and the anaerobic work, reducing the time to complete the trial for both groups (p<0.05).","[{'ForeName': 'Pamela Souza', 'Initials': 'PS', 'LastName': 'Santos', 'Affiliation': 'Federal University of Parana, 28122, Department of Physical Education, Curitiba, Parana, Brazil.'}, {'ForeName': 'Leandro Camati', 'Initials': 'LC', 'LastName': 'Felippe', 'Affiliation': 'Federal University of Pernambuco, Sport Science Research Group, Department of Physical Education and Sports Science (CAV), Vitória do Santo Antao, Pernambuco, Brazil.'}, {'ForeName': 'Guilherme Assunção', 'Initials': 'GA', 'LastName': 'Ferreira', 'Affiliation': 'Federal University of Pernambuco, 28116, Sport Science Research Group, Department of Physical Education and Sports Science (CAV), Vitoria do Santo Antao, Pernambuco, Brazil.'}, {'ForeName': 'Sara Kely', 'Initials': 'SK', 'LastName': 'Learsi DA Silva Santos Alves', 'Affiliation': 'Federal University of Pernambuco, 28116, Sport Science Research Group, Department of Physical Education and Sports Science (CAV), Vitoria do Santo Antao, Pernambuco, Brazil.'}, {'ForeName': 'Patrícia Guimarães', 'Initials': 'PG', 'LastName': 'Couto', 'Affiliation': 'University of Sao Paulo, 28133, Endurance Sports Research Group (GEDAE-USP), Sao Paulo, São Paulo, Brazil ; patriciagcouto@usp.br.'}, {'ForeName': 'Romulo', 'Initials': 'R', 'LastName': 'Bertuzzi', 'Affiliation': 'University of Sao Paulo, 28133, Endurance Sports Research Group (GEDAE-USP), Sao Paulo, São Paulo, Brazil ; bertuzzi@usp.br.'}, {'ForeName': 'Gleber', 'Initials': 'G', 'LastName': 'Pereira', 'Affiliation': 'Federal University of Parana, 28122, Department of Physical Education, Curitiba, Brazil ; gleber.pereira@gmail.com.'}, {'ForeName': 'Adriano Eduardo', 'Initials': 'AE', 'LastName': 'Lima-Silva', 'Affiliation': 'Universidade Tecnologica Federal do Parana, 74354, Human Performance Research Group , Pedro Gusso Street, Neoville , Curitiba, Parana, Brazil , 81310-900 ; aesilva@utfpr.edu.br.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0992']
1283,32407655,Methodology Matters: The Impact of Research Design on Conversational Entrainment Outcomes.,"Purpose Conversational entrainment describes the tendency for individuals to alter their communicative behaviors to more closely align with those of their conversation partner. This communication phenomenon has been widely studied, and thus, the methodologies used to examine it are diverse. Here, we summarize key differences in research design and present a test case to examine the effect of methodology on entrainment outcomes. Method Sixty neurotypical adults were randomly assigned to experimental groups formed by a 2 × 2 factorial combination of two independent variables: stimuli organization (blocked vs. random presentation) and stimuli modality (auditory-only vs. audiovisual stimuli). Individuals participated in a quasiconversational design in which the speech of a virtual interlocutor was manipulated to produce fast and slow speech rate conditions. Results There was a significant effect of stimuli organization on entrainment outcomes. Individuals in the blocked, but not the random, groups altered their speech rate to align with the speech rate of the virtual interlocutor. There were no effect of stimuli modality and no interaction between modality and organization on entrainment outcomes. Conclusion Findings highlight the importance of methodological decisions on entrainment outcomes. This underscores the need for more comprehensive research regarding entrainment methodology.",2020,There were no effect of stimuli modality and no interaction between modality and organization on entrainment outcomes.,"['Method Sixty neurotypical adults', 'Methodology Matters']",['stimuli organization (blocked vs. random presentation) and stimuli modality (auditory-only vs. audiovisual stimuli'],[],"[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0969625', 'cui_str': 'methodology'}]","[{'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}]",[],60.0,0.0260353,There were no effect of stimuli modality and no interaction between modality and organization on entrainment outcomes.,"[{'ForeName': 'Camille J', 'Initials': 'CJ', 'LastName': 'Wynn', 'Affiliation': 'Department of Communicative Disorders and Deaf Education, Utah State University, Logan.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Borrie', 'Affiliation': 'Department of Communicative Disorders and Deaf Education, Utah State University, Logan.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-19-00243']
1284,32407810,Mifepristone-misoprostol versus misoprostol-alone regimen for medication abortion at ≥24 weeks' gestation.,"OBJECTIVE


To compare time from misoprostol initiation to fetal expulsion for mifepristone-misoprostol versus misoprostol-alone regimens of medication abortion performed at ≥24 weeks' gestation.
STUDY DESIGN


We conducted a retrospective study of medication abortion performed at ≥24 weeks' gestation between May 2016 and January 2018 at one site, comparing outcomes of patients receiving mifepristone-misoprostol versus misoprostol alone during two periods. All patients received feticidal injection and laminaria; the mifepristone-misoprostol group also received mifepristone 200 mg orally around the time of initial laminaria. Beginning 24-72 hours later (depending on cervical assessment), both groups received misoprostol buccally every two hours.
RESULTS


Analyses included 257 patients in the mifepristone-misoprostol group and 152 patients in the misoprostol-alone group. Median time from misoprostol initiation to fetal expulsion was similar between groups (4.8 hours v. 4.9 hours; p=0.43). Patients in the mifepristone-misoprostol group received less misoprostol overall (median [IQR]: 800 mcg [800-1200 mcg] vs. 1200 mcg [800-1600 mcg]; p<0.01) and fewer patients received a second round of laminaria (n=56, 22% vs. n=58, 33%; p<0.01) than the misoprostol-alone group. Seven patients (2%) were transferred to a hospital for complications; this proportion did not vary by regimen.
CONCLUSIONS


Addition of mifepristone was not associated with a reduction in induction interval at ≥24 weeks. However, patients in the mifepristone-misoprostol group received a lower total dose of misoprostol and were less likely to require two days of laminaria. The clinical significance of these differences is unclear, but may have implications for patient experience. Both regimens had low rates of complications.
IMPLICATIONS STATEMENT


A randomized controlled trial comparing the mifepristone-misoprostol and misoprostol-alone regimens at ≥24 weeks is needed, as is evidence on patient perspectives on these regimens. Given the existing evidence, either regimen is reasonable.",2020,"Both regimens had low rates of complications.
","['257 patients in the', ""medication abortion at ≥24 weeks' gestation"", 'group and 152 patients in the misoprostol-alone group']","['Mifepristone-misoprostol', 'misoprostol-alone', 'mifepristone-misoprostol versus misoprostol', 'mifepristone', 'misoprostol-alone group', 'misoprostol', 'mifepristone-misoprostol', 'misoprostol-alone regimen', 'mifepristone-misoprostol and misoprostol-alone regimens']","['Median time from misoprostol initiation to fetal expulsion', 'low rates of complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}]","[{'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.139039,"Both regimens had low rates of complications.
","[{'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Wingo', 'Affiliation': 'Advancing New Standards in Reproductive Health (ANSIRH), Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco, 1330 Broadway Suite 1100, Oakland, CA 94612, USA. Electronic address: erin.wingo@ucsf.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Raifman', 'Affiliation': 'Advancing New Standards in Reproductive Health (ANSIRH), Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco, 1330 Broadway Suite 1100, Oakland, CA 94612, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Landau', 'Affiliation': ""Southwestern Women's Options, 522 Lomas Blvd NE, Albuquerque, NM 87102, USA.""}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Sella', 'Affiliation': ""Southwestern Women's Options, 522 Lomas Blvd NE, Albuquerque, NM 87102, USA.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Grossman', 'Affiliation': 'Advancing New Standards in Reproductive Health (ANSIRH), Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco, 1330 Broadway Suite 1100, Oakland, CA 94612, USA.'}]",Contraception,['10.1016/j.contraception.2020.05.001']
1285,30709665,"Cadazolid for the treatment of Clostridium difficile infection: results of two double-blind, placebo-controlled, non-inferiority, randomised phase 3 trials.","BACKGROUND


Cadazolid is a novel quinoxolidinone antibiotic developed for treating Clostridium difficile infection. We aimed to investigate the safety and efficacy of cadazolid compared with vancomycin in patients with C difficile infection.
METHODS


IMPACT 1 and IMPACT 2 were identically designed, multicentre, double-blind, placebo-controlled, non-inferiority, randomised phase 3 trials. IMPACT 1 was done in Australia, Brazil, Canada, France, Germany, Italy, the Netherlands, Peru, Poland, Romania, Spain, and the USA, and IMPACT 2 was done in Argentina, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Greece, Hungary, Israel, Romania, Slovakia, South Korea, the UK, and the USA. Patients (aged 18 years or older) with mild-to-moderate or severe C difficile infection (diarrhoea with positive glutamate dehydrogenase and toxin A or B enzyme immunoassays) were randomly assigned (1:1) with a randomisation list stratified by centre and C difficile infection episode type (block size of four), and allocation was masked to investigators and participants. Patients received either oral cadazolid 250 mg twice daily with vancomycin-matching placebo capsule four times daily or oral vancomycin 125 mg four times a day with cadazolid-matching placebo suspension twice daily for 10 days, with 30 days of follow-up. The primary efficacy outcome was non-inferiority (margin -10%) of cadazolid versus vancomycin for clinical cure in the modified intention-to-treat and per-protocol populations. Clinical cure was defined as resolution of diarrhoea with no additional treatment for C difficile infection. These trials are registered with ClinicalTrials.gov, numbers NCT01987895 (IMPACT 1) and NCT01983683 (IMPACT 2).
FINDINGS


Between March 28, 2014, and March 24, 2017, for IMPACT 1, and Dec 13, 2013, and May 2, 2017, for IMPACT 2, 1263 participants were randomly assigned to receive cadazolid (306 in IMPACT 1 and 298 in IMPACT 2) or vancomycin (326 in IMPACT 1 and 311 in IMPACT 2). In the modified intention-to-treat population in IMPACT 1, 253 (84%) of 302 had clinical cure in the cadazolid group versus 271 (85%) of 318 in the vancomycin group. In IMPACT 2, 235 (81%) of 290 versus 258 (86%) of 301 had clinical cure. In the per-protocol population, 247 (88%) of 282 versus 264 (92%) of 288 had clinical cure in IMPACT 1 and 214 (87%) of 247 versus 237 (92%) of 259 in IMPACT 2. Non-inferiority for clinical cure to vancomycin was shown in IMPACT 1 but not in IMPACT 2 (IMPACT 1 treatment difference: -1·4 [95% CI -7·2 to 4·3] for modified intention to treat and -4·1 [-9·2 to 1·0] for per protocol; IMPACT 2: -4·7 [-10·7 to 1·3] for modified intention to treat and -4·9 [-10·4 to 0·6] for per protocol). The safety and tolerability profiles of the two antibiotics were similar.
INTERPRETATION


Cadazolid was safe and well tolerated but did not achieve its primary endpoint of non-inferiority to vancomycin for clinical cure in one of two phase 3 C difficile infection trials. Therefore, further commercial development of cadazolid for C difficile infection is unlikely.
FUNDING


Actelion Pharmaceuticals.",2019,"INTERPRETATION


Cadazolid was safe and well tolerated but did not achieve its primary endpoint of non-inferiority to vancomycin for clinical cure in one of two phase 3 C difficile infection trials.","['patients with C difficile infection', 'Patients (aged 18 years or older) with mild-to-moderate or severe C difficile infection (diarrhoea with positive glutamate dehydrogenase and toxin A or B enzyme immunoassays', '1263 participants', 'Clostridium difficile infection']","['placebo', 'modified intention to treat and -4·9', 'cadazolid', 'vancomycin', 'cadazolid versus vancomycin', 'Cadazolid', 'oral cadazolid 250 mg twice daily with vancomycin-matching placebo capsule four times daily or oral vancomycin 125 mg four times a day with cadazolid-matching placebo suspension']","['safety and efficacy', 'safety and tolerability profiles', 'resolution of diarrhoea', 'clinical cure', 'Clinical cure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0017786', 'cui_str': 'L-Glutamate:NAD+ oxidoreductase (deaminating)'}, {'cui': 'C0076851', 'cui_str': 'toxin A (Pseudomonas)'}, {'cui': 'C0086231', 'cui_str': 'Enzyme Immunoassay'}, {'cui': 'C0343386', 'cui_str': 'Clostridium difficile infection (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C3885553', 'cui_str': 'cadazolid'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0585291', 'cui_str': 'Four times daily (qualifier value)'}, {'cui': 'C1598458', 'cui_str': 'Vancomycin 125 MG [Vancocin]'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",1263.0,0.705883,"INTERPRETATION


Cadazolid was safe and well tolerated but did not achieve its primary endpoint of non-inferiority to vancomycin for clinical cure in one of two phase 3 C difficile infection trials.","[{'ForeName': 'Dale N', 'Initials': 'DN', 'LastName': 'Gerding', 'Affiliation': 'Edward Hines Jr Veterans Administration Hospital, Hines, IL, USA. Electronic address: dale.gerding2@va.gov.'}, {'ForeName': 'Oliver A', 'Initials': 'OA', 'LastName': 'Cornely', 'Affiliation': 'Department of Internal Medicine, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases, Clinical Trials Centre Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Grill', 'Affiliation': 'Actelion Pharmaceuticals, Allschwil, Switzerland.'}, {'ForeName': 'Hilke', 'Initials': 'H', 'LastName': 'Kracker', 'Affiliation': 'Actelion Pharmaceuticals, Allschwil, Switzerland.'}, {'ForeName': 'Anne Claire', 'Initials': 'AC', 'LastName': 'Marrast', 'Affiliation': 'Actelion Pharmaceuticals, Allschwil, Switzerland.'}, {'ForeName': 'Carl Erik', 'Initials': 'CE', 'LastName': 'Nord', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'George H', 'Initials': 'GH', 'LastName': 'Talbot', 'Affiliation': 'Talbot Advisors, Anna Maria, FL, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Buitrago', 'Affiliation': 'Snake River Research, Idaho Falls, ID, USA.'}, {'ForeName': 'Iulian', 'Initials': 'I', 'LastName': 'Gheorghe Diaconescu', 'Affiliation': 'Victor Babes Clinical Hospital of Infectious Diseases and Pneumophysiology, Craiova, Romania.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Murta de Oliveira', 'Affiliation': 'Santa Casa de Belo Horizonte, Serviço de Controle de Infecção Hospitalar, Belo Horizonte, Brazil.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Preotescu', 'Affiliation': 'Matei Bals National Institute of Infectious Diseases, Bucharest, Romania.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Pullman', 'Affiliation': 'Mercury Street Medical Group, Butte, MT, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Louie', 'Affiliation': 'Foothills Medical Center, Alberta Health Services & University of Calgary, Cumming School of Medicine, Calgary, AB, Canada.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Wilcox', 'Affiliation': 'Microbiology, Old Medical School, Leeds General Infirmary, Leeds, UK.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30614-5']
1286,28916479,Dietary Nitrate Increases VO 2 peak and Performance but Does Not Alter Ventilation or Efficiency in Patients With Heart Failure With Reduced Ejection Fraction.,"BACKGROUND


Patients with heart failure with reduced ejection fraction (HFrEF) exhibit lower efficiency, dyspnea, and diminished peak oxygen uptake (VO 2 peak) during exercise. Dietary nitrate (NO 3 - ), a source of nitric oxide (NO), has improved these measures in some studies of other populations. We determined the effects of acute NO 3 -  ingestion on exercise responses in 8 patients with HFrEF using a randomized, double-blind, placebo-controlled, crossover design.
METHODS AND RESULTS


Plasma NO 3 - , nitrite (NO 2 - ), and breath NO were measured at multiple time points and respiratory gas exchange was determined during exercise after ingestion of beetroot juice containing or devoid of 11.2 mmol of NO 3 - . NO 3 -  intake increased (P < .05-0.001) plasma NO 3 -  and NO 2 -  and breath NO by 1469 ± 245%, 105 ± 34%, and 60 ± 18%, respectively. Efficiency and ventilation during exercise were unchanged. However, NO 3 -  ingestion increased (P < .05) VO 2 peak by 8 ± 2% (ie, from 21.4 ± 2.1 to 23.0 ± 2.3 mL . min -1. kg -1 ). Time to fatigue improved (P < .05) by 7 ± 3 % (ie, from 582 ± 84 to 612 ± 81 seconds).
CONCLUSIONS


Acute dietary NO 3 -  intake increases VO 2 peak and performance in patients with HFrEF. These data, in conjunction with our recent data demonstrating that dietary NO 3 -  also improves muscle contractile function, suggest that dietary NO 3 -  supplementation may be a valuable means of enhancing exercise capacity in this population.",2018,"However, NO 3 -  ingestion increased (P < .05) VO 2 peak by 8 ± 2% (ie, from 21.4 ± 2.1 to 23.0 ± 2.3 mL .","['Patients With Heart Failure With Reduced Ejection Fraction', '8 patients with HFrEF', 'patients with HFrEF', 'Patients with heart failure with reduced ejection fraction (HFrEF']","['acute NO 3 -  ingestion', 'Dietary nitrate (NO 3 - ', 'placebo']","['Efficiency and ventilation during exercise', 'muscle contractile function', 'Time to fatigue', 'multiple time points and respiratory gas exchange', 'NO 3 - , nitrite (NO 2 - ), and breath', 'peak oxygen uptake']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}]",8.0,0.0838639,"However, NO 3 -  ingestion increased (P < .05) VO 2 peak by 8 ± 2% (ie, from 21.4 ± 2.1 to 23.0 ± 2.3 mL .","[{'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Coggan', 'Affiliation': 'Department of Kinesiology, Indiana University Purdue University Indianapolis, Indianapolis, Indiana; Department of Cellular and Integrative Physiology, Indiana University Purdue University Indianapolis, Indianapolis, Indiana; Department of Radiology, Washington University School of Medicine, St. Louis, Missouri. Electronic address: acoggan@iupui.edu.'}, {'ForeName': 'Seth R', 'Initials': 'SR', 'LastName': 'Broadstreet', 'Affiliation': 'Department of Kinesiology, Indiana University Purdue University Indianapolis, Indianapolis, Indiana.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Mahmood', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Deana', 'Initials': 'D', 'LastName': 'Mikhalkova', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Madigan', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Indra', 'Initials': 'I', 'LastName': 'Bole', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Soo', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Leibowitz', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Kadkhodayan', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Deepak P', 'Initials': 'DP', 'LastName': 'Thomas', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Dakkota', 'Initials': 'D', 'LastName': 'Thies', 'Affiliation': 'Department of Radiology, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Peterson', 'Affiliation': 'Department of Radiology, Washington University School of Medicine, St. Louis, Missouri; Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2017.09.004']
1287,25646024,Does Increased Consolidated Nighttime Sleep Facilitate Attentional Control? A Pilot Study of Nap Restriction in Preschoolers.,"OBJECTIVE


The aim of this study is to understand the impact of a 5-day period of nap restriction on sleep patterns and cognitive function in typically developing preschoolers, aged 3 to 4 years.
METHOD


Following 1 week of baseline assessment, 28 children were randomly assigned to either a ""napping as usual"" group ( n = 15) or a 5-day period of nap restriction ( n = 13). Sleep was assessed with sleep logs and actigraphy; cognition was assessed at baseline and at the end of the intervention week.
RESULTS


No group differences in sleep or cognitive function were observed at baseline. For the no-nap group, the 5-day period of daytime nap restriction resulted in increased nighttime sleep. Children in the no-nap group also showed a significant improvement in attentional control compared with baseline, whereas no such changes were observed among children in the napping-as-usual group.
CONCLUSION


In preschool children who typically take naps, short-term nap restriction is associated with increased nighttime sleep and may contribute to improved attentional function.",2019,"Children in the no-nap group also showed a significant improvement in attentional control compared with baseline, whereas no such changes were observed among children in the napping-as-usual group.
","['typically developing preschoolers, aged 3 to 4 years', 'Preschoolers', '28 children', 'preschool children who typically take naps, short-term nap restriction']","['Nap Restriction', 'napping as usual"" group ( n = 15) or a 5-day period of nap restriction', 'nap restriction']","['sleep logs and actigraphy; cognition', 'Sleep', 'attentional control', 'sleep patterns and cognitive function', 'attentional function', 'sleep or cognitive function', 'nighttime sleep']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0067518', 'cui_str': 'NAPS'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C0067518', 'cui_str': 'NAPS'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0474396', 'cui_str': 'Sleep pattern finding'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",28.0,0.0249515,"Children in the no-nap group also showed a significant improvement in attentional control compared with baseline, whereas no such changes were observed among children in the napping-as-usual group.
","[{'ForeName': 'Janet C', 'Initials': 'JC', 'LastName': 'Lam', 'Affiliation': '1 Kennedy Krieger Institute, Baltimore, MD, USA.'}, {'ForeName': 'Taylor A', 'Initials': 'TA', 'LastName': 'Koriakin', 'Affiliation': '1 Kennedy Krieger Institute, Baltimore, MD, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Scharf', 'Affiliation': '3 University of Maryland, Baltimore, USA.'}, {'ForeName': 'Thornton B A', 'Initials': 'TBA', 'LastName': 'Mason', 'Affiliation': ""4 Children's Hospital of Philadelphia, PA, USA.""}, {'ForeName': 'E Mark', 'Initials': 'EM', 'LastName': 'Mahone', 'Affiliation': '1 Kennedy Krieger Institute, Baltimore, MD, USA.'}]",Journal of attention disorders,['10.1177/1087054715569281']
1288,29396374,"Efficacy of vildagliptin for prevention of postpartum diabetes in women with a recent history of insulin-requiring gestational diabetes: A phase II, randomized, double-blind, placebo-controlled study.","OBJECTIVE


Women with insulin-requiring gestational diabetes mellitus (GDM) are at high risk of developing diabetes within a few years postpartum. We implemented this phase II study to test the hypothesis that vildagliptin, a dipeptidyl peptidase-4 inhibitor, is superior to placebo in terms of reducing the risk of postpartum diabetes.
METHODS


Women with insulin-requiring GDM were randomized to either placebo or 50 mg vildagliptin twice daily for 24 months followed by a 12-month observation period (EudraCT: 2007-000634-39). Both groups received lifestyle counseling. The primary efficacy outcomes were the diagnosis of diabetes (American Diabetes Association (ADA) criteria) or impaired fasting glucose (IFG)/impaired glucose tolerance (IGT).
RESULTS


Between 2008 and 2015, 113 patients (58 vildagliptin, 55 placebo) were randomized within 2.2-10.4 (median 8.6) months after delivery. At the interim analysis, nine diabetic events and 28 IFG/IGT events had occurred. Fifty-two women withdrew before completing the treatment phase. Because of the low diabetes rate, the study was terminated. Lifestyle adherence was similar in both groups. At 24 months, the cumulative probability of postpartum diabetes was 3% and 5% (hazard ratio: 1.03; 95% confidence interval: 0.15-7.36) and IFG/IGT was 43% and 22% (hazard ratio: 0.55; 95% confidence interval: 0.26-1.19) in the placebo and vildagliptin groups, respectively. Vildagliptin was well tolerated with no unexpected adverse events.
CONCLUSIONS


The study did not show significant superiority of vildagliptin over placebo in terms of reducing the risk of postpartum diabetes. However, treatment was safe and suggested some improvements in glycemic control, insulin resistance, and β-cell function. The study identified critical issues in performing clinical trials in the early postpartum period in women with GDM hampering efficacy assessments. With this knowledge, we have set a basis for which properly powered trials could be performed in women with recent GDM. TRIAL REGISTRATION NUMBER AT CLINICALTRIALS.GOV: NCT01018602.",2018,The study did not show significant superiority of vildagliptin over placebo in terms of reducing the risk of postpartum diabetes.,"['Women with insulin-requiring gestational diabetes mellitus (GDM', 'women with GDM hampering efficacy assessments', 'Between 2008 and 2015, 113 patients (58', 'women with a recent history of insulin-requiring gestational diabetes', 'Women with insulin-requiring GDM', 'women with recent GDM']","['placebo', 'vildagliptin', 'vildagliptin, 55 placebo', 'lifestyle counseling', 'Vildagliptin']","['glycemic control, insulin resistance, and β-cell function', 'Lifestyle adherence', 'postpartum diabetes', 'cumulative probability of postpartum diabetes', 'risk of postpartum diabetes', 'diagnosis of diabetes (American Diabetes Association (ADA) criteria) or impaired fasting glucose (IFG)/impaired glucose tolerance (IGT']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0181113', 'cui_str': 'Hamper (physical object)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}]",,0.225407,The study did not show significant superiority of vildagliptin over placebo in terms of reducing the risk of postpartum diabetes.,"[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Hummel', 'Affiliation': 'Forschergruppe Diabetes e.V. am Helmholtz Zentrum München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany; Institute of Diabetes Research, Helmholtz Zentrum München, and Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Beyerlein', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, and Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Pfirrmann', 'Affiliation': 'Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie (IBE), Ludwig-Maximilians University Munich, Marchioninistr. 15, 81377 München, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hofelich', 'Affiliation': 'Forschergruppe Diabetes e.V. am Helmholtz Zentrum München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany; Institute of Diabetes Research, Helmholtz Zentrum München, and Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Much', 'Affiliation': 'Forschergruppe Diabetes e.V. am Helmholtz Zentrum München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany; Institute of Diabetes Research, Helmholtz Zentrum München, and Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Hivner', 'Affiliation': 'Forschergruppe Diabetes e.V. am Helmholtz Zentrum München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany; Institute of Diabetes Research, Helmholtz Zentrum München, and Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Bunk', 'Affiliation': 'Forschergruppe Diabetes e.V. am Helmholtz Zentrum München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Herbst', 'Affiliation': 'Forschergruppe Diabetes e.V. am Helmholtz Zentrum München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Peplow', 'Affiliation': 'Forschergruppe Diabetes e.V. am Helmholtz Zentrum München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany; Institute of Diabetes Research, Helmholtz Zentrum München, and Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Walter', 'Affiliation': 'Forschergruppe Diabetes e.V. am Helmholtz Zentrum München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Kohn', 'Affiliation': 'Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie (IBE), Ludwig-Maximilians University Munich, Marchioninistr. 15, 81377 München, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Hummel', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, and Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Kratzsch', 'Affiliation': 'Institut für Laboratoriumsmedizin, Klinische Chemie und Molekulare Diagnostik, Uniklinikum Leipzig, Paul-List-Str. 13/15, 04103 Leipzig, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hummel', 'Affiliation': 'Forschergruppe Diabetes e.V. am Helmholtz Zentrum München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Füchtenbusch', 'Affiliation': 'Forschergruppe Diabetes e.V. am Helmholtz Zentrum München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Hasford', 'Affiliation': 'Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie (IBE), Ludwig-Maximilians University Munich, Marchioninistr. 15, 81377 München, Germany.'}, {'ForeName': 'Anette-G', 'Initials': 'AG', 'LastName': 'Ziegler', 'Affiliation': 'Forschergruppe Diabetes e.V. am Helmholtz Zentrum München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany; Institute of Diabetes Research, Helmholtz Zentrum München, and Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany. Electronic address: anette-g.ziegler@helmholtz-muenchen.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Molecular metabolism,['10.1016/j.molmet.2017.12.015']
1289,30679107,"Four courses versus eight courses of adjuvant S-1 for patients with stage II gastric cancer (JCOG1104 [OPAS-1]): an open-label, phase 3, non-inferiority, randomised trial.","BACKGROUND


Postoperative adjuvant chemotherapy with S-1 for 1 year (corresponding to eight courses) is standard care for stage II gastric cancer. Whether the duration of S-1 could be shortened to 6 months (corresponding to four courses) without worsening survival is unclear. The aim of this study was to investigate the non-inferiority of four courses of S-1 compared with eight courses of S-1 for patients with stage II gastric cancer.
METHODS


We did a phase 3, open-label, randomised controlled, non-inferiority trial at 59 hospitals in Japan. Patients aged 20-80 years with stage II adenocarcinoma of the stomach were randomly assigned (1:1) to eight courses or four courses of S-1. Randomisation was done by the Japan Clinical Oncology Group Data Center website, using a minimisation method with a random component using institution, stage (IIA vs IIB), age (<70 years vs ≥70 years), and mode of operation (open gastrectomy with bursectomy vs open gastrectomy without bursectomy vs laparoscopic gastrectomy) as adjustment factors. One course was 80 mg/day per m 2  of S-1 administered for 4 weeks followed by a rest for 2 weeks. The primary endpoint was relapse-free survival, analysed by intention to treat, with a non-inferiority margin for the hazard ratio (HR) set at 1·37. This study is registered at UMIN-Clinical Trial Registry, number UMIN000007306.
FINDINGS


Between Feb 16, 2012, and March 19, 2017, 590 patients were enrolled (295 per group). 528 (89%) patients were analysed at the first planned interim analysis in March, 2017, at which time the point estimate of HR for the four-course group compared with the eight-course group was 2·52 (95% CI 1·11-5·77), which exceeded 1·37 and met the prespecified criteria for early termination. Predictive probability for showing non-inferiority at the final analysis was calculated to be 2·9%. The study was stopped for futility. Updated 3-year relapse-free survival analysed in May, 2017, was 93·1% (95% CI 87·8-96·1) for the eight-course group and 89·8% (84·2-93·5) for the four-course group (HR 1·84, 95% CI 0·93-3·63). The most common grade 3-4 adverse event was neutropenia, observed in 46 (16%) patients in the eight-course group and 51 (17%) patients in the four-course group.
INTERPRETATION


S-1 for 1 year should remain as standard adjuvant chemotherapy for stage II gastric cancer.
FUNDING


Japan Agency for Medical Research and Development; the Ministry of Health, Labour and Welfare of Japan; the National Cancer Center Research and Development Fund, Japan.",2019,"The most common grade 3-4 adverse event was neutropenia, observed in 46 (16%) patients in the eight-course group and 51 (17%) patients in the four-course group.
","['patients with stage II gastric cancer (JCOG1104 [OPAS-1', 'stage II gastric cancer', 'Between Feb 16, 2012, and March 19, 2017', '590 patients were enrolled (295 per group', 'Patients aged 20-80 years with stage II adenocarcinoma of the stomach', '59 hospitals in Japan', 'patients with stage II gastric cancer']","['S-1', 'mode of operation (open gastrectomy with bursectomy vs open gastrectomy without bursectomy vs laparoscopic gastrectomy', 'adjuvant S-1']","['neutropenia', 'relapse-free survival, analysed by intention to treat, with a non-inferiority margin for the hazard ratio (HR', 'Updated 3-year relapse-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C3714551', 'cui_str': 'Stomach structure (body structure)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0185298', 'cui_str': 'Resection of bursa'}]","[{'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",590.0,0.245289,"The most common grade 3-4 adverse event was neutropenia, observed in 46 (16%) patients in the eight-course group and 51 (17%) patients in the four-course group.
","[{'ForeName': 'Takaki', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Gastric Surgery, National Cancer Center Hospital, Chuo-Ku, Tokyo, Japan. Electronic address: tayoshik@ncc.go.jp.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Terashima', 'Affiliation': 'Division of Gastric Surgery, Shizuoka Cancer Center, Nagaizumi-cho, Sunto-gun, Shizuoka Prefecture, Japan.'}, {'ForeName': 'Junki', 'Initials': 'J', 'LastName': 'Mizusawa', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Chuo-Ku, Tokyo, Japan.'}, {'ForeName': 'Souya', 'Initials': 'S', 'LastName': 'Nunobe', 'Affiliation': 'Gastroenterological Surgery, Cancer Institute Ariake Hospital, Koto-Ku, Tokyo, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Nishida', 'Affiliation': 'Department of Surgery, Keiyukai Sapporo Hospital, Siroishi-Ku, Sapporo, Japan.'}, {'ForeName': 'Takanobu', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 2-3-2 Nakao, Asahi-Ku, Japan.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Kaji', 'Affiliation': 'Department of Surgery, Toyama Prefectural Central Hospital, Toyama, Japan.'}, {'ForeName': 'Norimasa', 'Initials': 'N', 'LastName': 'Fukushima', 'Affiliation': 'Department of Surgery, Yamagata Prefectural Central Hospital, Yamagata, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Hato', 'Affiliation': 'Department of Surgery, National Hospital Organization, Shikoku Cancer Center, Minami-umemotocho, Matsuyama Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Choda', 'Affiliation': 'Department of Surgery, Hiroshima City Hiroshima Citizens Hospital, Naka-Ku, Hiroshima, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yabusaki', 'Affiliation': 'Department of Digestive Surgery, Niigata Cancer Center Hospital, Kawagishimachi, Chuo-Ku, Niigata, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Department of Surgical Oncology, Gifu University, Graduate School of Medicine, Gifu City, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Chikusa-ku, Nagoya.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takeno', 'Affiliation': 'Department of Surgery, Kansai Rosai Hospital, Amagasaki, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yasuda', 'Affiliation': 'Department of Gastroenterological Surgery, Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Kawachi', 'Affiliation': 'Department of Surgery, Nagaoka Chuo General Hospital, Nagaoka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Katayama', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Chuo-Ku, Tokyo, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Fukuda', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Chuo-Ku, Tokyo, Japan.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Chuo-Ku, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sano', 'Affiliation': 'Gastroenterological Surgery, Cancer Institute Ariake Hospital, Koto-Ku, Tokyo, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Sasako', 'Affiliation': 'Department of Multidisciplinary Surgical Oncology, Hyogo College of Medicine, Nishinomiya, Japan.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(18)30383-2']
1290,30698279,Vitamin D and Falls in Older African American Women: The PODA Randomized Clinical Trial.,"BACKGROUND


Limited information is available on the influence of vitamin D on falls in older high-functioning black American women. Endocrine Society guidelines propose serum 25(OH)D levels over 30 ng/mL.
OBJECTIVE


To determine if maintenance of serum 25(OH)D above 30 ng/mL protects against falls.
DESIGN


The Physical Performance, Osteoporosis and Vitamin D in African American Women (PODA) trial had a prospective, randomized, placebo-controlled, double-dummy design with two arms: one with placebo and one with vitamin D 3  adjusted to maintain serum 25(OH)D above 30 ng/mL. The primary outcomes were the prevention of bone loss and the decline in physical performance.
PATIENTS


The target population was healthy black women older than 60 years with serum 25(OH)D between 8 and 26 ng/mL. The trial was 3 years in duration with a falls questionnaire administered every 3 months. A total of 260 women entered the study, and 184 completed the 3 years. Mean age was 68.2 years.
SETTING


Research center in an academic health center.
MAIN OUTCOMES MEASURE


Prevention of falls.
INTERVENTION


Participants were randomly assigned to placebo or active vitamin D. Vitamin D 3  dose was adjusted to maintain serum 25(OH)D above 30 ng/mL in the active group using a double-dummy design.
RESULTS


Baseline 25(OH)D was 22 ng/mL. Mean serum 25(OH)D reached 47 ng/mL in the active group compared with 21 ng/mL in the placebo group. There were 14.2% falls in the previous year recalled at baseline. During the study, 46% reported falling in the treatment group compared with 47% in the placebo group. There was no association of serum 25(OH)D or vitamin D dose with the risk of falling.
CONCLUSIONS


There is no benefit of maintaining serum 25(OH)D above 30 ng/mL compared with the Institute of Medicine recommendation (20 ng/mL) in preventing falls in healthy older black American women. J Am Geriatr Soc 67:1043-1049, 2019.",2019,"There was no association of serum 25(OH)D or vitamin D dose with the risk of falling.
","['African American Women (PODA', 'Research center in an academic health center', 'older high-functioning black American women', 'Mean age was 68.2 years', 'A total of 260 women entered the study, and 184 completed the 3 years', 'healthy black women older than 60 years with serum 25(OH)D between 8 and 26 ng/mL', 'healthy older black American women', 'Older African American Women']","['vitamin D', 'placebo or active vitamin D. Vitamin D', 'Vitamin D and Falls', 'placebo and one with vitamin D', 'placebo']","['prevention of bone loss and the decline in physical performance', 'serum 25(OH)D or vitamin D', 'Mean serum 25(OH)D', 'Prevention of falls', 'serum 25(OH)D levels', 'Physical Performance, Osteoporosis and Vitamin D']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0000921', 'cui_str': 'Falls'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C2607857'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]",260.0,0.540694,"There was no association of serum 25(OH)D or vitamin D dose with the risk of falling.
","[{'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Aloia', 'Affiliation': 'NYU Winthrop Hospital, Mineola, New York.'}, {'ForeName': 'Rakhil', 'Initials': 'R', 'LastName': 'Rubinova', 'Affiliation': 'NYU Winthrop Hospital, Mineola, New York.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Fazzari', 'Affiliation': 'NYU Winthrop Hospital, Mineola, New York.'}, {'ForeName': 'Shahidul', 'Initials': 'S', 'LastName': 'Islam', 'Affiliation': 'NYU Winthrop Hospital, Mineola, New York.'}, {'ForeName': 'Mageda', 'Initials': 'M', 'LastName': 'Mikhail', 'Affiliation': 'NYU Winthrop Hospital, Mineola, New York.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Ragolia', 'Affiliation': 'NYU Winthrop Hospital, Mineola, New York.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.15760']
1291,31685694,Estimating the social value of mechanical thrombectomy randomized trials on an established stroke network.,"BACKGROUND


Given the relative strength of prior mechanical thrombectomy (MT) data in face of the perceived poor natural history of emergent large vessel occlusion strokes, randomization to medical therapy during the recent clinical MT trials raised ethical challenges at individual and institutional levels despite overall clinical equipoise.
METHODS


In a thrombectomy stroke registry, we compared treatment rates preceding and following the SWIFT-PRIME and DAWN trials. Based on effect sizes of treatment in both trials, we estimated missed opportunities due to randomization to medical therapy and estimated the societal benefit resulting from additional patients who benefited as a result of these studies.
RESULTS


The average monthly thrombectomy rate in the SWIFT-PRIME time window increased from 14.1±4 patients-per-month (ppm) to 23.8±6 ppm (p<0·001). Twelve subjects were enrolled in SWIFT-PRIME and we estimated a missed opportunity of benefiting 2.3 of six subjects randomized to medical therapy. This was offset by providing treatment to an additional 9.7 ppm, resulting in an additional functional benefit to 3.7 ppm. Similarly, the thrombectomy rate in the DAWN window increased from 8.6±4 ppm pre-DAWN to 11.9±3.6 ppm post-DAWN (p<0.01). 38 subjects were enrolled in the DAWN trial with a missed opportunity to benefit eight of 16 subjects randomized to medical therapy. This was offset by the ability to offer MT to an additional 3.3 ppm, bringing definite benefit to an additional 1.65 ppm.
CONCLUSION


Completion of recent trials resulted in observable increases in rates of thrombectomy, translating to functional benefits that rapidly offset any missed opportunities due to randomization to medical therapy arms.",2020,"Similarly, the thrombectomy rate in the DAWN window increased from 8.6±4 ppm pre-DAWN to 11.9±3.6 ppm post-DAWN (p<0.01).","['38 subjects were enrolled in the DAWN trial with a missed opportunity to benefit eight of 16 subjects randomized to', 'Twelve subjects were enrolled in SWIFT-PRIME and we estimated a missed opportunity of benefiting 2.3 of six subjects randomized to']",['medical therapy'],[],"[{'cui': 'C1831581', 'cui_str': 'Subfamily Apodinae'}]","[{'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]",[],38.0,0.0553262,"Similarly, the thrombectomy rate in the DAWN window increased from 8.6±4 ppm pre-DAWN to 11.9±3.6 ppm post-DAWN (p<0.01).","[{'ForeName': 'Gabriel Martins', 'Initials': 'GM', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Neurology, Marcus Stroke & Neuroscience Center - Grady Memorial Hospital / Emory University, Atlanta, Georgia, United States.'}, {'ForeName': 'Diogo C', 'Initials': 'DC', 'LastName': 'Haussen', 'Affiliation': 'Department of Neurology, Marcus Stroke & Neuroscience Center - Grady Memorial Hospital / Emory University, Atlanta, Georgia, United States.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Bouslama', 'Affiliation': 'Department of Neurology, Marcus Stroke & Neuroscience Center - Grady Memorial Hospital / Emory University, Atlanta, Georgia, United States.'}, {'ForeName': 'Srikant', 'Initials': 'S', 'LastName': 'Rangaraju', 'Affiliation': 'Department of Neurology, Marcus Stroke & Neuroscience Center - Grady Memorial Hospital / Emory University, Atlanta, Georgia, United States.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Frankel', 'Affiliation': 'Department of Neurology, Marcus Stroke & Neuroscience Center - Grady Memorial Hospital / Emory University, Atlanta, Georgia, United States.'}, {'ForeName': 'Raul G', 'Initials': 'RG', 'LastName': 'Nogueira', 'Affiliation': 'Department of Neurology, Marcus Stroke & Neuroscience Center - Grady Memorial Hospital / Emory University, Atlanta, Georgia, United States rnoguei@emory.edu.'}]",Journal of neurointerventional surgery,['10.1136/neurintsurg-2019-015204']
1292,32408253,Effect of amino acids on IGF1 gene expression in human myotubes and skeletal muscle.,"OBJECTIVE


Insulin-like growth factor I (IGF1) is an important regulator of collagen and extracellular matrix protein expression. We aimed to evaluate the effect of amino acids (AAs) on expression of IGF1 and IGF1-dependent genes in human myotubes and skeletal muscle and supposed that AAs administration increases IGF1 levels in blood and expression of IGF1 and IGF1-dependent genes in trained skeletal muscle, thereby reducing training-induced muscle damage.
DESIGN


Human myotubes were incubated with Arg and Leu for 24 h. Then, the effects of long-term branched chain AAs administration (10 weeks, 0.1 g/kg body mass/day) to volunteers (six subjects per AAs and placebo groups) performing large training volumes regularly (cross country skiers, training twice a day) were examined.
RESULTS


Incubating the myotubes with AAs increases expression of IGF1 mRNA isoforms and IGF1 secretion by 2-3 times. In athletes, long-term AAs administration increased basal blood levels of IGF1 (~50%) and expression of IGF1Ea mRNA slightly in skeletal muscle. There is no marked increase in expression of COL1A1, COL3A1, COL5A1, and LOX genes in skeletal muscle after AAs administration. However, expression of these genes in the combined group (placebo + AAs; n = 12) significantly correlated with the expression of IGF1Ea mRNA in muscle and did not correlate with IGF1 levels in the blood.
CONCLUSIONS


AAs administration increases IGF1 expression in vitro and in vivo. To obtain more pronounced changes in expression of IGF1 and IGF1-dependent genes in skeletal muscle, it may be necessary to increase the dose and/or duration of AAs administration.",2020,"There is no marked increase in expression of COL1A1, COL3A1, COL5A1, and LOX genes in skeletal muscle after AAs administration.","['human myotubes and skeletal muscle', 'Human myotubes were incubated with Arg and Leu for 24\xa0h']","['Insulin-like growth factor', 'amino acids', 'amino acids (AAs']","['IGF1 gene expression', 'IGF1 expression', 'basal blood levels of IGF1', 'expression of IGF1 mRNA isoforms and IGF1 secretion', 'expression of IGF1Ea mRNA', 'expression of COL1A1, COL3A1, COL5A1, and LOX genes in skeletal muscle', 'IGF1 levels']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1704336', 'cui_str': 'Skeletal muscle fiber'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}]","[{'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}]","[{'cui': 'C0202220', 'cui_str': 'Somatomedin-C measurement'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0597298', 'cui_str': 'Isoforms'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0972255', 'cui_str': 'type I collagen alpha 1'}, {'cui': 'C0024375', 'cui_str': 'Protein-lysine 6-oxidase'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}]",,0.0302591,"There is no marked increase in expression of COL1A1, COL3A1, COL5A1, and LOX genes in skeletal muscle after AAs administration.","[{'ForeName': 'Egor M', 'Initials': 'EM', 'LastName': 'Lednev', 'Affiliation': 'Institute of Biomedical Problems of the RAS, 76A Khoroshevskoye Shosse, Moscow 123007, Russian Federation. Electronic address: ledhauz@gmail.com.'}, {'ForeName': 'Irina V', 'Initials': 'IV', 'LastName': 'Kravchenko', 'Affiliation': 'Federal Research Centre «Fundamentals of Biotechnology» of the Russian Academy of Sciences, 33 build 2, Leninsky prospect, Moscow 119071, Russian Federation.'}, {'ForeName': 'Vladimir A', 'Initials': 'VA', 'LastName': 'Furalyov', 'Affiliation': 'Federal Research Centre «Fundamentals of Biotechnology» of the Russian Academy of Sciences, 33 build 2, Leninsky prospect, Moscow 119071, Russian Federation.'}, {'ForeName': 'Evgeny A', 'Initials': 'EA', 'LastName': 'Lysenko', 'Affiliation': 'Institute of Biomedical Problems of the RAS, 76A Khoroshevskoye Shosse, Moscow 123007, Russian Federation.'}, {'ForeName': 'Iulia S', 'Initials': 'IS', 'LastName': 'Lemesheva', 'Affiliation': 'Institute of Biomedical Problems of the RAS, 76A Khoroshevskoye Shosse, Moscow 123007, Russian Federation.'}, {'ForeName': 'Alexandr A', 'Initials': 'AA', 'LastName': 'Grushin', 'Affiliation': 'Russian Olympic Committee, Luzhnetskaya Embankment 8, Russia, Moscow 119991, Russian Federation.'}, {'ForeName': 'Vadim E', 'Initials': 'VE', 'LastName': 'Dubrov', 'Affiliation': 'Lomonosov Moscow State University, Faculty of Fundamental Medicine, 27 build. 1, Lomonosovsky Prospekt, Moscow 119991, Russian Federation.'}, {'ForeName': 'Olga L', 'Initials': 'OL', 'LastName': 'Vinogradova', 'Affiliation': 'Institute of Biomedical Problems of the RAS, 76A Khoroshevskoye Shosse, Moscow 123007, Russian Federation.'}, {'ForeName': 'Daniil V', 'Initials': 'DV', 'LastName': 'Popov', 'Affiliation': 'Institute of Biomedical Problems of the RAS, 76A Khoroshevskoye Shosse, Moscow 123007, Russian Federation.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.101323']
1293,30685489,"Laparoscopic versus open pancreatoduodenectomy for pancreatic or periampullary tumours (LEOPARD-2): a multicentre, patient-blinded, randomised controlled phase 2/3 trial.","BACKGROUND


Laparoscopic pancreatoduodenectomy may improve postoperative recovery compared with open pancreatoduodenectomy. However, there are concerns that the extensive learning curve of this complex procedure could increase the risk of complications. We aimed to assess whether laparoscopic pancreatoduodenectomy could reduce time to functional recovery compared with open pancreatoduodenectomy.
METHODS


This multicentre, patient-blinded, parallel-group, randomised controlled phase 2/3 trial was performed in four centres in the Netherlands that each do 20 or more pancreatoduodenectomies annually; surgeons had to have completed a dedicated training programme for laparoscopic pancreatoduodenectomy and have done 20 or more laparoscopic pancreatoduodenectomies before trial participation. Patients with a benign, premalignant, or malignant indication for pancreatoduodenectomy, without signs of vascular involvement, were randomly assigned (1:1) to undergo either laparoscopic or open pancreatoduodenectomy using a central web-based system. Randomisation was stratified for annual case volume and preoperative estimated risk of pancreatic fistula. Patients were blinded to treatment allocation. Analysis was done according to the intention-to-treat principle. The main objective of the phase 2 part of the trial was to assess the safety of laparoscopic pancreatoduodenectomy (complications and mortality), and the primary outcome of phase 3 was time to functional recovery in days, defined as all of the following: adequate pain control with only oral analgesia; independent mobility; ability to maintain more than 50% of the daily required caloric intake; no need for intravenous fluid administration; and no signs of infection (temperature <38·5°C). This trial is registered with Trialregister.nl, number NTR5689.
FINDINGS


Between May 13 and Dec 20, 2016, 42 patients were randomised in the phase 2 part of the trial. Two patients did not receive surgery and were excluded from analyses in accordance with the study protocol. Three (15%) of 20 patients died within 90 days after laparoscopic pancreatoduodenectomy, compared with none of 20 patients after open pancreatoduodenectomy. Based on safety data from the phase 2 part of the trial, the data and safety monitoring board and protocol committee agreed to proceed with phase 3. Between Jan 31 and Nov 14, 2017, 63 additional patients were randomised in phase 3 of the trial. Four patients did not receive surgery and were excluded from analyses in accordance with the study protocol. After randomisation of 105 patients (combining patients from both phase 2 and phase 3), of whom 99 underwent surgery, the trial was prematurely terminated by the data and safety monitoring board because of a difference in 90-day complication-related mortality (five [10%] of 50 patients in the laparoscopic pancreatoduodenectomy group vs one [2%] of 49 in the open pancreatoduodenectomy group; risk ratio [RR] 4·90 [95% CI 0·59-40·44]; p=0·20). Median time to functional recovery was 10 days (95% CI 5-15) after laparoscopic pancreatoduodenectomy versus 8 days (95% CI 7-9) after open pancreatoduodenectomy (log-rank p=0·80). Clavien-Dindo grade III or higher complications (25 [50%] of 50 patients after laparoscopic pancreatoduodenectomy vs 19 [39%] of 49 after open pancreatoduodenectomy; RR 1·29 [95% CI 0·82-2·02]; p=0·26) and grade B/C postoperative pancreatic fistulas (14 [28%] vs 12 [24%]; RR 1·14 [95% CI 0·59-2·22]; p=0·69) were comparable between groups.
INTERPRETATION


Although not statistically significant, laparoscopic pancreatoduodenectomy was associated with more complication-related deaths than was open pancreatoduodenectomy, and there was no difference between groups in time to functional recovery. These safety concerns were unexpected and worrisome, especially in the setting of trained surgeons working in centres performing 20 or more pancreatoduodenectomies annually. Experience, learning curve, and annual volume might have influenced the outcomes; future research should focus on these issues.
FUNDING


Grant for investigator-initiated studies by Johnson & Johnson Medical Limited.",2019,Median time to functional recovery was 10 days (95% CI 5-15) after laparoscopic pancreatoduodenectomy versus 8 days (95% CI 7-9) after open pancreatoduodenectomy (log-rank p=0·80).,"['42 patients were randomised in the phase 2 part of the trial', 'Patients with a benign, premalignant, or malignant indication for pancreatoduodenectomy, without signs of vascular involvement', 'Between Jan 31 and Nov 14, 2017, 63 additional patients', 'Between May 13 and Dec 20, 2016', '4·90', 'four centres in the Netherlands that each do 20 or more pancreatoduodenectomies annually; surgeons had to have completed a dedicated training programme for laparoscopic pancreatoduodenectomy and have done 20 or more laparoscopic pancreatoduodenectomies before trial participation']","['Laparoscopic pancreatoduodenectomy', 'open pancreatoduodenectomy', 'adequate pain control with only oral analgesia', 'pancreatoduodenectomy', 'laparoscopic pancreatoduodenectomy', 'laparoscopic or open pancreatoduodenectomy using a central web-based system', 'Laparoscopic versus open pancreatoduodenectomy']","['Median time to functional recovery', 'grade B/C postoperative pancreatic fistulas', 'Clavien-Dindo grade III or higher complications', 'time to functional recovery', 'safety of laparoscopic pancreatoduodenectomy (complications and mortality', 'risk of complications', 'postoperative recovery', '90-day complication-related mortality', 'risk ratio [RR', 'complication-related deaths']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441806', 'cui_str': 'Grade B (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic Fistula'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",42.0,0.429736,Median time to functional recovery was 10 days (95% CI 5-15) after laparoscopic pancreatoduodenectomy versus 8 days (95% CI 7-9) after open pancreatoduodenectomy (log-rank p=0·80).,"[{'ForeName': 'Jony', 'Initials': 'J', 'LastName': 'van Hilst', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Netherlands.'}, {'ForeName': 'Thijs', 'Initials': 'T', 'LastName': 'de Rooij', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Netherlands.'}, {'ForeName': 'Koop', 'Initials': 'K', 'LastName': 'Bosscha', 'Affiliation': ""Department of Surgery, Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Brinkman', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, Netherlands.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'van Dieren', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Netherlands.'}, {'ForeName': 'Marcel G', 'Initials': 'MG', 'LastName': 'Dijkgraaf', 'Affiliation': 'Clinical Research Unit, Amsterdam UMC, University of Amsterdam, Netherlands.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Gerhards', 'Affiliation': 'Department of Surgery, OLVG, Amsterdam, Netherlands.'}, {'ForeName': 'Ignace H', 'Initials': 'IH', 'LastName': 'de Hingh', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, Netherlands; Netherlands Comprehensive Cancer Organisation (IKNL), Utrecht, Netherlands.'}, {'ForeName': 'Tom M', 'Initials': 'TM', 'LastName': 'Karsten', 'Affiliation': 'Department of Surgery, OLVG, Amsterdam, Netherlands.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Lips', 'Affiliation': ""Department of Surgery, Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands; Department of Surgery, Medisch Spectrum Twente, Enschede, Netherlands.""}, {'ForeName': 'Misha D', 'Initials': 'MD', 'LastName': 'Luyer', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, Netherlands.'}, {'ForeName': 'Olivier R', 'Initials': 'OR', 'LastName': 'Busch', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Festen', 'Affiliation': 'Department of Surgery, OLVG, Amsterdam, Netherlands.'}, {'ForeName': 'Marc G', 'Initials': 'MG', 'LastName': 'Besselink', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Netherlands. Electronic address: m.g.besselink@amc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30004-4']
1294,32407901,"A novel, extended prophylactic antibiotic regimen in preterm pre-labor rupture of membranes: a randomized trial.","OBJECTIVES


Prophylactic antibiotic use in preterm pre-labor rupture of membranes (PPROM) is associated with a significant reduction in intra-amniotic infection and improved neonatal outcome. However, data is insufficient to determine the optimal antibiotic regimen. Considering the rise in Escherichia coli and Klebsiella pneumonia early-onset sepsis rate and the emergence of ampicillin resistance, our aim is to compare the efficiency of two antibiotic regimens in prolonging pregnancy and reducing infectious morbidity.
DESIGN


This multicenter randomized unblinded controlled prospective trial compared two antibiotic prophylactic protocols in PPROM: ampicillin + roxithromycin vs cefuroxime + roxithromycin in 84 women with PPROM, from 12/2015-12/2019.
RESULTS


The median latency period was significantly longer (p = 0.039) in the cefuroxime + roxithromycin group (4.63 [0.59-50.18] days) than in the ampicillin + roxithromycin group (2.3 [0.15-58.3] days). Neonatal admission to neonatal intensive care unit rate, hospitalization length, neonatal respiratory distress syndrome, neonatal fever, and need for respiratory support or mechanical ventilation, were similar between the groups. K. pneumonia cultures were significantly more frequent in the ampicillin + roxithromycin group. None of the cultures were group B Streptococcus positive.
CONCLUSIONS


To prolong latency period and reduce gram-negative early-onset sepsis, cefuroxime + roxithromycin is recommended as the first-line protocol in PPROM.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02819570.",2020,The median latency period was significantly longer (p = 0.039) in the cefuroxime + roxithromycin group (4.63 [0.59-50.18] days) than in the ampicillin + roxithromycin group (2.3 [0.15-58.3] days).,"['preterm pre-labor rupture of membranes', 'PPROM', '84 women with PPROM, from 12/2015-12/2019', 'preterm pre-labor rupture of membranes (PPROM']","['ampicillin\u2009+\u2009roxithromycin vs cefuroxime\u2009+\u2009roxithromycin', 'ampicillin\u2009+\u2009roxithromycin', 'cefuroxime\u2009+\u2009roxithromycin', 'prophylactic antibiotic regimen']","['K. pneumonia cultures', 'median latency period', 'Neonatal admission to neonatal intensive care unit rate, hospitalization length, neonatal respiratory distress syndrome, neonatal fever, and need for respiratory support or mechanical ventilation']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0233308', 'cui_str': 'Spontaneous rupture of fetal membranes'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0002680', 'cui_str': 'Ampicillin'}, {'cui': 'C0035891', 'cui_str': 'Roxithromycin'}, {'cui': 'C0007562', 'cui_str': 'Cefuroxime'}, {'cui': 'C0362063', 'cui_str': 'Other prophylactic chemotherapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023103', 'cui_str': 'Latency Period (Psychology)'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0235839', 'cui_str': 'Fever of the newborn'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",84.0,0.100097,The median latency period was significantly longer (p = 0.039) in the cefuroxime + roxithromycin group (4.63 [0.59-50.18] days) than in the ampicillin + roxithromycin group (2.3 [0.15-58.3] days).,"[{'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Frank Wolf', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, and Azrieli Faculty of Medicine, Bar Ilan University, Israel. Electronic address: homesickid@yahoo.com.'}, {'ForeName': 'Inshirah', 'Initials': 'I', 'LastName': 'Sgayer', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, and Azrieli Faculty of Medicine, Bar Ilan University, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Miron', 'Affiliation': 'Department of Pediatrics A, Emek Medical Center, Afula, and Rappaport Faculty of Medicine, Technion- Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Krencel', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, and Azrieli Faculty of Medicine, Bar Ilan University, Israel.'}, {'ForeName': 'Vered Fleisher', 'Initials': 'VF', 'LastName': 'Sheffer', 'Affiliation': 'Neonatal Intensive Care Unit, Galilee Medical Center, Nahariya, and Azrieli Faculty of Medicine, Bar Ilan University, Israel.'}, {'ForeName': 'Suraya Saied', 'Initials': 'SS', 'LastName': 'Idriss', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center and Technion - Israel Institute of Technology.'}, {'ForeName': 'Rami N', 'Initials': 'RN', 'LastName': 'Sammour', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center and Technion - Israel Institute of Technology.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Peleg', 'Affiliation': 'Department of Obstetrics and Gynecology, Ziv Medical Center, Safed and Azrieli Faculty of Medicine, Bar Ilan University, Israel.'}, {'ForeName': 'Inbar Ben', 'Initials': 'IB', 'LastName': 'Shachar', 'Affiliation': 'Department of Obstetrics and Gynecology, Ziv Medical Center, Safed and Azrieli Faculty of Medicine, Bar Ilan University, Israel.'}, {'ForeName': 'Hagai', 'Initials': 'H', 'LastName': 'Rechnitzer', 'Affiliation': 'Clinical Microbiology Laboratory, Galilee Medical Center, Nahariya, and Azrieli Faculty of Medicine, Bar Ilan University, Israel.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bornstein', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, and Azrieli Faculty of Medicine, Bar Ilan University, Israel.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.05.005']
1295,30683239,Cost-effectiveness of urine-based tuberculosis screening in hospitalised patients with HIV in Africa: a microsimulation modelling study.,"BACKGROUND


Testing urine improves the number of tuberculosis diagnoses made among patients in hospital with HIV. In conjunction with the two-country randomised Rapid Urine-based Screening for Tuberculosis to Reduce AIDS-related Mortality in Hospitalised Patients in Africa (STAMP) trial, we used a microsimulation model to estimate the effects on clinical outcomes and the cost-effectiveness of adding urine-based tuberculosis screening to sputum screening for hospitalised patients with HIV.
METHODS


We compared two tuberculosis screening strategies used irrespective of symptoms among hospitalised patients with HIV in Malawi and South Africa: a GeneXpert assay (Cepheid, Sunnyvale, CA, USA) for Mycobacterium tuberculosis and rifampicin resistance (Xpert) in sputum samples (standard of care) versus sputum Xpert combined with a lateral flow assay for M tuberculosis lipoarabinomannan in urine (Determine TB-LAM Ag test, Abbott, Waltham, MA, USA [formerly Alere]; TB-LAM) and concentrated urine Xpert (intervention). A cohort of simulated patients was modelled using selected characteristics of participants, tuberculosis diagnostic yields, and use of hospital resources in the STAMP trial. We calibrated 2-month model outputs to the STAMP trial results and projected clinical and economic outcomes at 2 years, 5 years, and over a lifetime. We judged the intervention to be cost-effective if the incremental cost-effectiveness ratio (ICER) was less than US$750/year of life saved (YLS) in Malawi and $940/YLS in South Africa. A modified intervention of adding only TB-LAM to the standard of care was also evaluated. We did a budget impact analysis of countrywide implementation of the intervention.
FINDINGS


The intervention increased life expectancy by 0·5-1·2 years and was cost-effective, with an ICER of $450/YLS in Malawi and $840/YLS in South Africa. The ICERs decreased over time. At lifetime horizon, the intervention remained cost-effective under nearly all modelled assumptions. The modified intervention was at least as cost-effective as the intervention (ICERs $420/YLS in Malawi and $810/YLS in South Africa). Over 5 years, the intervention would save around 51 000 years of life in Malawi and around 171 000 years of life in South Africa. Health-care expenditure for screened individuals was estimated to increase by $37 million (10·8%) and $261 million (2·8%), respectively.
INTERPRETATION


Urine-based tuberculosis screening of all hospitalised patients with HIV could increase life expectancy and be cost-effective in resource-limited settings. Urine TB-LAM is especially attractive because of high incremental diagnostic yield and low additional cost compared with sputum Xpert, making a compelling case for expanding its use to all hospitalised patients with HIV in areas with high HIV burden and endemic tuberculosis.
FUNDING


UK Medical Research Council, UK Department for International Development, Wellcome Trust, US National Institutes of Health, Royal College of Physicians, Massachusetts General Hospital.",2019,"The intervention increased life expectancy by 0·5-1·2 years and was cost-effective, with an ICER of $450/YLS in Malawi and $840/YLS in South Africa.","['hospitalised patients with HIV in Africa', 'hospitalised patients with HIV', 'hospitalised patients with HIV in areas with high HIV burden and endemic tuberculosis', 'hospitalised patients with HIV in Malawi and South Africa', 'patients in hospital with HIV', 'Hospitalised Patients in Africa (STAMP) trial']","['urine-based tuberculosis screening to sputum screening', 'urine-based tuberculosis screening']","['incremental cost-effectiveness ratio (ICER', 'ICERs', 'life expectancy', 'Cost-effectiveness', 'Health-care expenditure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital (finding)'}]","[{'cui': 'C0042037'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0420004', 'cui_str': 'Tuberculosis screening (procedure)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}]",,0.136736,"The intervention increased life expectancy by 0·5-1·2 years and was cost-effective, with an ICER of $450/YLS in Malawi and $840/YLS in South Africa.","[{'ForeName': 'Krishna P', 'Initials': 'KP', 'LastName': 'Reddy', 'Affiliation': 'Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, MA, USA; Division of Pulmonary and Critical Care Medicine, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: kpreddy@mgh.harvard.edu.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Gupta-Wright', 'Affiliation': 'TB Centre, London School of Hygiene & Tropical Medicine, London, UK; Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Fielding', 'Affiliation': 'TB Centre, London School of Hygiene & Tropical Medicine, London, UK; University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Costantini', 'Affiliation': 'Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Zheng', 'Affiliation': 'Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Corbett', 'Affiliation': 'TB Centre, London School of Hygiene & Tropical Medicine, London, UK; Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi.'}, {'ForeName': 'Liyang', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Joep J', 'Initials': 'JJ', 'LastName': 'van Oosterhout', 'Affiliation': 'Dignitas International, Zomba, Malawi; Department of Medicine, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Resch', 'Affiliation': 'Department of Health Policy and Management, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Douglas P', 'Initials': 'DP', 'LastName': 'Wilson', 'Affiliation': 'Department of Internal Medicine, Edendale Hospital, University of KwaZulu-Natal, Pietermaritzburg, South Africa.'}, {'ForeName': 'C Robert', 'Initials': 'CR', 'LastName': 'Horsburgh', 'Affiliation': 'Department of Epidemiology, Boston University School of Medicine, Boston, MA, USA; Section of Infectious Diseases, Department of Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Wood', 'Affiliation': 'Desmond Tutu HIV Foundation, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Alufandika-Moyo', 'Affiliation': 'Dignitas International, Zomba, Malawi.'}, {'ForeName': 'Jurgens A', 'Initials': 'JA', 'LastName': 'Peters', 'Affiliation': 'TB Centre, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Freedberg', 'Affiliation': 'Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, MA, USA; Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA, USA; Division of Infectious Diseases, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Department of Health Policy and Management, Harvard T H Chan School of Public Health, Boston, MA, USA; Department of Epidemiology, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Lawn', 'Affiliation': 'TB Centre, London School of Hygiene & Tropical Medicine, London, UK; Desmond Tutu HIV Foundation, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Rochelle P', 'Initials': 'RP', 'LastName': 'Walensky', 'Affiliation': 'Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, MA, USA; Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA, USA; Division of Infectious Diseases, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}]",The Lancet. Global health,['10.1016/S2214-109X(18)30436-4']
1296,32407947,"Intralymphatic immunotherapy for mountain cedar pollinosis: A randomized, double-blind, placebo-controlled trial.","BACKGROUND


Allergen immunotherapy can provide long-term benefits, including symptomatic relief and reduced disease progression, but requires a lengthy regimen that presents barriers to patient adherence. Thus, there is a need for improved approaches to immunotherapy. Recently, several clinical trials have reported successful results from intralymphatic immunotherapy.
OBJECTIVE


To evaluate the efficacy, safety and tolerability of intralymphatic immunotherapy for allergies caused by mountain cedar pollen in a proof-of-concept study.
METHODS


Twenty-one patients with allergic rhinoconjunctivitis due to mountain cedar pollen were randomized to receive three monthly intralymphatic injections of allergenic extract or placebo prior to the 2018-2019 mountain cedar pollen season. Safety was monitored during treatment thru the end of pollen season using structured and spontaneous reports. Clinical efficacy information was collected using a daily electronic diary of symptoms and allergy medication. Allergen-specific serum IgE was assessed before treatment and at the end of the study.
RESULTS


There were no serious adverse events or systemic reactions in either group. Four patients experienced mild injection-site reactions. Patients receiving intralymphatic immunotherapy experienced a significant improvement in allergy symptoms and medication use relative to patients receiving placebo (p < 0.001) and the active treatment group had lower average total combined scores on 20 of 27 days during peak pollen season (p < 0.05). There was not a significant difference between groups in changes to mean mountain cedar-specific serum IgE levels.
CONCLUSION


In this proof-of-concept trial, intralymphatic immunotherapy was well tolerated and reduced the symptoms and medication use associated with allergic rhinoconjunctivitis caused by mountain cedar pollen.",2020,Patients receiving intralymphatic immunotherapy experienced a significant improvement in allergy symptoms and medication use relative to patients receiving placebo (p < 0.001) and the active treatment group had lower average total combined scores on 20 of 27 days during peak pollen season (p < 0.05).,"['mountain cedar pollinosis', 'prior to the 2018-2019 mountain cedar pollen season', 'Twenty-one patients with allergic rhinoconjunctivitis due to mountain cedar pollen']","['allergenic extract or placebo', 'intralymphatic immunotherapy', 'Intralymphatic immunotherapy', 'placebo']","['Safety', 'allergy symptoms and medication use relative', 'serious adverse events or systemic reactions', 'efficacy, safety and tolerability', 'mild injection-site reactions', 'mean mountain cedar-specific serum IgE levels', 'average total combined scores']","[{'cui': 'C0330154', 'cui_str': 'Juniperus mexicana'}, {'cui': 'C0018621', 'cui_str': 'Seasonal allergic rhinitis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0440386', 'cui_str': 'Mountain cedar pollen'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0861154', 'cui_str': 'Allergic rhinoconjunctivitis'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0440016', 'cui_str': 'Allergenic extract'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1512956', 'cui_str': 'Intralymphatic route'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0330154', 'cui_str': 'Juniperus mexicana'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",21.0,0.239599,Patients receiving intralymphatic immunotherapy experienced a significant improvement in allergy symptoms and medication use relative to patients receiving placebo (p < 0.001) and the active treatment group had lower average total combined scores on 20 of 27 days during peak pollen season (p < 0.05).,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Thompson', 'Affiliation': 'Aspire Allergy & Sinus, Austin, TX. Electronic address: drthompson@aspireallergy.com.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Silvers', 'Affiliation': 'Aspire Allergy & Sinus, Austin, TX.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Shapiro', 'Affiliation': 'Pharma Initiatives Consulting, Chapel Hill, NC.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2020.04.030']
1297,31465818,Randomized controlled clinical trial of resin infiltration in primary molars: 2 years follow-up.,"OBJECTIVE


The aim of this split-mouth, randomized, controlled clinical trial was to evaluate the efficacy of resin infiltration in controlling the progression of non-cavitated proximal lesions in primary molars after two-years follow-up.
METHODS


Fifty healthy children presenting at least two primary molars with proximal lesion detected radiographically (in the inner half of enamel or the outer third of dentin) were included in the study. The proximal lesions were randomly allocated into resin infltration + flossing (test group) or flossing (control group). All patients received oral hygiene instructions for daily brushing with fluoride toothpaste (1100 ppmF) and flossing. The proportion of caries progression was compared using the McNemar test. The main outcome after 2-years, caries progression in the radiography was assessed by pair-wise reading by an independent examiner who was blind regarding the treatment.
RESULTS


The sample comprised 28 (56%) girls and 22 (44%) boys with a defs of 7,3 (SD = 6,5), mainly of moderate (46%) to high (48%) caries risk. Results after one year were published previously. After 2-years, 29 (58%) patients were assessed. Caries progression was observed in 24.1% (7/29) of the test lesions, compared with 55.2% (16/29) of the control lesions (p = 0.012). The therapeutic effect was 31.1% and the relative risk reduction (RRR) was 56.3%. Eigth lesions from the control group and two lesions from the test group progressed to the inner third of dentin and were restored.
CONCLUSIONS


In conclusion, resin infiltration was more efficacious in controlling proximal caries lesions in primary molars than non-invasive approach alone.
CLINICAL SIGNIFICANCE


The results indicate that resin infiltration was an efficacious method in controlling proximal caries lesions in primary molars after 2 years, even in patients with high caries risk, reaffirming the results of 1-year follow-up.",2019,"The results indicate that resin infiltration was an efficacious method in controlling proximal caries lesions in primary molars after 2 years, even in patients with high caries risk, reaffirming the results of 1-year follow-up.","['Fifty healthy children presenting at least two primary molars with proximal lesion detected radiographically (in the inner half of enamel or the outer third of dentin) were included in the study', 'primary molars', 'The sample comprised 28 (56%) girls and 22 (44%) boys with a defs of 7,3 (SD\u2009=\u20096,5), mainly of moderate (46%) to high (48%) caries risk', 'primary molars after two-years follow-up']","['resin infltration\u2009+\u2009flossing (test group) or flossing (control group', 'oral hygiene instructions', 'fluoride toothpaste (1100ppmF) and flossing', 'resin infiltration']","['Caries progression', 'proximal caries lesions', 'proportion of caries progressions', 'relative risk reduction (RRR', 'therapeutic effect', 'caries progression']","[{'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C4041253', 'cui_str': 'Inner half of enamel'}, {'cui': 'C4038556', 'cui_str': 'Outer third of dentin (body structure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0054282', 'cui_str': 'tribufos'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1527144'}]",50.0,0.0686572,"The results indicate that resin infiltration was an efficacious method in controlling proximal caries lesions in primary molars after 2 years, even in patients with high caries risk, reaffirming the results of 1-year follow-up.","[{'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Jorge', 'Affiliation': 'Department of Preventive and Community Dentistry, School of Dentistry, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, RJ, Brazil; Dental School, Faculty of Arthur Sá Earp Neto, Petrópolis, RJ, Brazil.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Ammari', 'Affiliation': 'Department of Specific Training, School of Dentistry, Universidade Federal Fluminense - UFF, Nova Friburgo, RJ, Brazil; Department of Pediatric Dentistry and Orthodontics, School of Dentistry, Universidade Federal do Rio de Janeiro, UFRJ, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'V M', 'Initials': 'VM', 'LastName': 'Soviero', 'Affiliation': 'Department of Preventive and Community Dentistry, School of Dentistry, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, RJ, Brazil; Dental School, Faculty of Arthur Sá Earp Neto, Petrópolis, RJ, Brazil. Electronic address: verasoviero@gmail.com.'}, {'ForeName': 'I P R', 'Initials': 'IPR', 'LastName': 'Souza', 'Affiliation': 'Department of Pediatric Dentistry and Orthodontics, School of Dentistry, Universidade Federal do Rio de Janeiro, UFRJ, Rio de Janeiro, RJ, Brazil.'}]",Journal of dentistry,['10.1016/j.jdent.2019.103184']
1298,32107269,"Electroacupuncture for treatment-resistant insomnia: study protocol for a randomised, controlled, assessor-blinded, pilot clinical trial.","INTRODUCTION


A considerable number of insomnia patients experience sleep disturbance even with long-term use of hypnotic medication. Previous studies have indicated that electroacupuncture (EA) could be an efficacious treatment for managing insomnia. However, few trials have been conducted to evaluate the effectiveness and safety of EA for treatment-resistant insomnia. This pilot study aims to explore the feasibility and preliminary effectiveness and safety of EA as an adjunct treatment for treatment-resistant insomnia.
METHODS AND ANALYSIS


This is a multicentre, randomised, usual care controlled and assessor-blinded pilot study protocol. Fifty patients presenting with sleep problems who have been taking hypnotic medication for more than 3 months will be randomly allocated to either an EA group or a usual care group at a 1:1 ratio. The EA group will undergo 12 EA treatment sessions twice a week for 6 weeks whereas the usual care group will not receive EA treatment. All the participants will receive a brochure containing educational information on sleep hygiene. The primary outcome will be the measured mean change of the total score of the Insomnia Severity Index from the baseline to week 7. The secondary outcome regarding sleep quality will be measured using the Pittsburgh Sleep Quality Index, a sleep diary and actigraphy. Moreover, we will assess the quality of life, the direct and indirect cost of treating insomnia for economic evaluation. After 4 weeks, the subjects will visit the research sites for a follow-up assessment.
ETHICS AND DISSEMINATION


Ethical approval of this study protocol was established by the institutional review boards of the each involved study site. All potential subjects will be provided written informed consent. The results of this study will be accessible in peer-reviewed publications and be presented at academic conference.
TRIAL REGISTRATION NUMBER


KCT0003235.",2020,The primary outcome will be the measured mean change of the total score of the Insomnia Severity Index from the baseline to week 7.,['Fifty patients presenting with sleep problems who have been taking hypnotic medication for more than 3 months'],"['Electroacupuncture', 'usual care group will not receive EA treatment', 'EA', 'brochure containing educational information', 'electroacupuncture (EA', 'EA group or a usual care']","['mean change of the total score of the Insomnia Severity Index', 'quality of life', 'sleep quality will be measured using the Pittsburgh Sleep Quality Index, a sleep diary and actigraphy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0020591', 'cui_str': 'Hypnotics'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0034380'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}]",50.0,0.115802,The primary outcome will be the measured mean change of the total score of the Insomnia Severity Index from the baseline to week 7.,"[{'ForeName': 'Jung-Hwa', 'Initials': 'JH', 'LastName': 'Lim', 'Affiliation': 'Department of Neuropsychiatry, School of Korean Medicine, Pusan National University, Yangsan-si, Gyeongsanganm-do, Korea (the Republic of).'}, {'ForeName': 'Kyung-Ok', 'Initials': 'KO', 'LastName': 'Kim', 'Affiliation': 'Department of Oriental Neuropsychiatry, Dongshin University College of Korean Medicine, Gwangju, Korea (the Republic of).'}, {'ForeName': 'Sang-Ho', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Neuropsychiatry of Korean Medicine, Pohang Korean Medicine Hospital, Daegu Haany University College of Oriental Medicine, Pohang-si, Gyeongsangbuk-do, Korea (the Republic of).'}, {'ForeName': 'Chang-Wan', 'Initials': 'CW', 'LastName': 'Kang', 'Affiliation': 'Division of Industrial Convergence System Engineering, Dong Eui University, Busan, Busan, Korea (the Republic of).'}, {'ForeName': 'Bo-Kyung', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Department of Neuropsychiatry, School of Korean Medicine, Pusan National University, Yangsan-si, Gyeongsanganm-do, Korea (the Republic of) npjolie@hanmail.net.'}]",BMJ open,['10.1136/bmjopen-2019-034239']
1299,31687762,Efficacy and safety of edoxaban compared with warfarin according to the burden of diseases in patients with atrial fibrillation: insights from the ENGAGE AF-TIMI 48 trial.,"AIMS


Non-vitamin K antagonist oral anticoagulants represent a new option for prevention of embolic events in patients with atrial fibrillation (AF). However, little is known about the impact of non-cardiac comorbidities on the efficacy and safety profile of these drugs.
METHODS AND RESULTS


In a post hoc analysis of the ENGAGE AF-TIMI 48 trial, we analysed 21 105 patients with AF followed for an average of 2.8 years and randomized to either a higher-dose edoxaban regimen (HDER), a lower-dose edoxaban regimen, or warfarin. We used the updated Charlson Comorbidity Index (CCI) to stratify the patients according to the burden of concomitant disease (CCI = 0, 1, 2, 3, and ≥4). The treatment groups were then compared for safety, efficacy, and net clinical outcomes across CCI categories. There were 32.0%, 7.3%, 42.1%, 12.7%, and 6.0% of patients with CCI scores of 0, 1, 2, 3, and ≥4, respectively. A CCI score ≥4 was associated with significantly higher rates of thromboembolic events, bleeding, and death compared to CCI = 0 (P < 0.05 for each). The annualized rates of the primary net clinical outcome (stroke/systemic embolism, major bleeding, or death) for CCI = 0, 1, 2, 3, or ≥4 were 5.9%, 8.7%, 6.6%, 10.3%, and 13.6% (Ptrend < 0.001). There were no significant interactions between treatment with HDER vs. warfarin and efficacy, safety, and net outcomes across the CCI groups (P-interaction > 0.10 for each).
CONCLUSION 


Although increasing CCI scores are associated with worse outcomes, the efficacy, safety, and net clinical outcomes of edoxaban vs. warfarin were independent of the degree of comorbidity present.",2020,"There were no significant interactions between treatment with HDER vs warfarin and efficacy, safety, and net outcomes across the CCI groups (P-interaction >0.10 for each).
","['21,105 patients with AF followed for an average of 2.8 years', 'patients with atrial fibrillation (AF', 'Patients with Atrial Fibrillation']","['edoxaban regimen (HDER), a lower-dose edoxaban regimen (LDER), or warfarin', 'edoxaban', 'HDER vs warfarin', 'Warfarin', 'vitamin K antagonist oral anticoagulants', 'Edoxaban']","['thromboembolic events, bleeding, and death', 'safety, efficacy', 'efficacy, safety, and net outcomes', 'CCI scores', 'Efficacy and Safety', 'efficacy, safety', 'Updated Charlson Comorbidity Index (CCI', 'annualized rates of the primary net clinical outcome (stroke/systemic embolism, major bleeding, or death) for CCI=0, 1, 2, 3 or\u2009≥\u20094']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}]","[{'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index (assessment scale)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.0264034,"There were no significant interactions between treatment with HDER vs warfarin and efficacy, safety, and net outcomes across the CCI groups (P-interaction >0.10 for each).
","[{'ForeName': 'André M', 'Initials': 'AM', 'LastName': 'Nicolau', 'Affiliation': 'Escola Paulista de Medicina, Universidade Federal de São Paulo, Rua Botucatu, 720 São Paulo, Brazil.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Corbalan', 'Affiliation': 'Hospital Clinico Pontificia Universidad Catolica de Chile, Facultad de Medicina, Santiago, Chile.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Departamento de Cardiopneumologia, Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Ruff', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Hale Building, Room 7022, 60 Fenwood Road, Boston, MA 02115, USA.""}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Zierhut', 'Affiliation': 'Daiichi Sankyo Europe GmbH, Medical Affairs Antithrombotic & Cardiovascular Therapeutic Area, Zielstattstraße 48, 81379 Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kerschnitzki', 'Affiliation': 'Daiichi Sankyo Europe GmbH, Medical Affairs Antithrombotic & Cardiovascular Therapeutic Area, Zielstattstraße 48, 81379 Munich, Germany.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Duris', 'Affiliation': 'Fakultná nemocnica s poliklinikou, Nové Zámky, Slovakia.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Juul-Möller', 'Affiliation': 'Skåne University Hospital (SUS), Malmö, Sweden.'}, {'ForeName': 'Juri', 'Initials': 'J', 'LastName': 'Voitk', 'Affiliation': 'Department of Invasive Cardiology, Center of Cardiology, North Estonia Medical Center Foundation, J. Sütiste tee 19, 13419 Tallinn, Estonia.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Trevisan', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Nordio', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Hale Building, Room 7022, 60 Fenwood Road, Boston, MA 02115, USA.""}, {'ForeName': 'Elliott M', 'Initials': 'EM', 'LastName': 'Antman', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Hale Building, Room 7022, 60 Fenwood Road, Boston, MA 02115, USA.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Hale Building, Room 7022, 60 Fenwood Road, Boston, MA 02115, USA.""}]",European heart journal. Cardiovascular pharmacotherapy,['10.1093/ehjcvp/pvz061']
1300,32407835,An anti-IL-13 antibody reverses epithelial-mesenchymal transition biomarkers in eosinophilic esophagitis: phase 2 trial results.,"BACKGROUND


Fibrostenosis, the most serious eosinophilic esophagitis (EoE) complication, is mediated by epithelial-mesenchymal transition (EMT). Transitioned cells contribute to pathogenesis by overproducing extracellular matrix.
OBJECTIVE


To determine whether RPC4046 (anti‒IL-13 monoclonal antibody) modulates EMT biomarkers in biopsies from adults with active EoE in a substudy of a double-blind, placebo-controlled phase 2 trial.
METHODS


Baseline and week-16 esophageal biopsies were taken from 69 patients randomized to weekly subcutaneous RPC4046 180 mg (n=19), 360 mg (n=26), or placebo (n=24). Duplex immunofluorescence slides stained for e-cadherin and vimentin were digitally analyzed by mapping each epithelial cell and recording fluorescence intensities. Endpoints included change from baseline to week 16 in percentage vimentin-positive epithelial cells (primary), total e-cadherin, and vimentin:e-cadherin ratio per cell (average of 47,000 cells/biopsy analyzed).
RESULTS


Mean percentage vimentin-positive cells decreased 0.94%, 2.75%, and 4.24% in the placebo, low-dose, and high-dose groups (P = 0.032, high-dose vs placebo). Mean e-cadherin expression per cell increased 5.6-fold in both dose groups versus placebo (high-dose P = 0.047). Increases in e-cadherin per cell from baseline to week 16 were correlated with improvements in histology, eosinophil counts, endoscopic findings, and symptoms.
CONCLUSION


RPC4046 significantly reduced EMT markers in adults with active EoE, with greater effects at 360 mg. Together with results for eosinophil density and clinical endpoints from the main trial, these data support the hypothesis that pharmacologic IL-13 inhibition ameliorates both inflammatory and remodeling pathways, and could potentially reduce the risk of fibrostenotic complications.",2020,"Increases in e-cadherin per cell from baseline to week 16 were correlated with improvements in histology, eosinophil counts, endoscopic findings, and symptoms.
","['biopsies from adults with active EoE', 'eosinophilic esophagitis']","['subcutaneous RPC4046', 'RPC4046', 'RPC4046 (anti‒IL-13 monoclonal antibody', 'placebo']","['EMT markers', 'Mean e-cadherin expression per cell', 'percentage vimentin-positive epithelial cells (primary), total e-cadherin, and vimentin:e-cadherin ratio per cell (average of 47,000 cells/biopsy analyzed', 'histology, eosinophil counts, endoscopic findings, and symptoms', 'Mean percentage vimentin-positive cells']","[{'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0341106', 'cui_str': 'Eosinophilic esophagitis'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4547951', 'cui_str': 'RPC4046'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1523298', 'cui_str': 'Epithelial-Mesenchymal Transformation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042172', 'cui_str': 'E-Cadherin'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0042666', 'cui_str': 'Vimentin'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0014597', 'cui_str': 'Epithelial cell'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}]",69.0,0.430787,"Increases in e-cadherin per cell from baseline to week 16 were correlated with improvements in histology, eosinophil counts, endoscopic findings, and symptoms.
","[{'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Gann', 'Affiliation': 'Department of Pathology, University of Illinois College of Medicine, Chicago, IL, U.S. Electronic address: pgann@uic.edu.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Deaton', 'Affiliation': 'Department of Pathology, University of Illinois College of Medicine, Chicago, IL, U.S.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'McMahon', 'Affiliation': 'Department of Pathology, University of Illinois College of Medicine, Chicago, IL, U.S.'}, {'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Collins', 'Affiliation': ""Division of Pathology and Laboratory Medicine, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, U.S.""}, {'ForeName': 'Evan S', 'Initials': 'ES', 'LastName': 'Dellon', 'Affiliation': 'Department of Medicine, Univ. of North Carolina School of Medicine, Chapel Hill, NC, U.S.'}, {'ForeName': 'Ikuo', 'Initials': 'I', 'LastName': 'Hirano', 'Affiliation': 'Northwestern University, Feinberg School of Medicine, Chicago, IL, U.S.'}, {'ForeName': 'Steven Ye', 'Initials': 'SY', 'LastName': 'Hua', 'Affiliation': 'Celgene Corporation, Summit, NJ, U.S.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Rodriguez', 'Affiliation': 'Celgene Corporation, Summit, NJ, U.S.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'Celgene Corporation, Summit, NJ, U.S.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.03.045']
1301,30695166,Effects of an Online Mindfulness Intervention Focusing on Attention Monitoring and Acceptance in Pregnant Women: A Randomized Controlled Trial.,"INTRODUCTION


Attention monitoring and acceptance underlie the effects of mindfulness meditation. This study tested the feasibility and acceptability of an online mindfulness intervention for pregnant women as an approach to reduce depressive and anxious symptoms.
METHOD


We developed an 8-week mindfulness intervention program that trained participants to monitor their internal and external experiences in an accepting way. The mindfulness course was based on the Wechat platform. This study was conducted in a women's hospital in China. A total of 123 women with scores on the Generalized Anxiety Disorder Scale and Patient Health Questionnaire suggesting mild or moderate symptoms of depression and anxiety were recruited from the outpatient department between April and June 2018. The participants were randomized to receive the mindfulness intervention or routine prenatal care. The Generalized Anxiety Disorder Scale, the Patient Health Questionnaire, and the Five Facets of Mindfulness Questionnaire were used to evaluate the levels of anxiety, depression, and mindfulness, respectively, before and after the intervention.
RESULTS


Of the 123 women enrolled in this study, 10 in the intervention group and 11 in the control group did not complete the intervention. The retention rate and feedback suggested that the mindfulness intervention was feasible and acceptable among pregnant women. Participants in the intervention group showed greater declines in depressive and anxious symptoms compared with those in the control group, as well a significant improvement in mindfulness skills (eg, attention monitoring and acceptance).
DISCUSSION


These results suggest that an online mindfulness intervention may be a promising technique to help women use mindfulness skills to reduce depressive and anxious symptoms. The mindfulness intervention could constitute part of the psychological care provided to pregnant women.",2019,"Participants in the intervention group showed greater declines in depressive and anxious symptoms compared with those in the control group, as well a significant improvement in mindfulness skills (eg, attention monitoring and acceptance).
","[""women's hospital in China"", 'Pregnant Women', '123 women with scores on the Generalized Anxiety Disorder Scale and Patient Health Questionnaire suggesting mild or moderate symptoms of depression and anxiety were recruited from the outpatient department between April and June 2018', 'pregnant women', '123 women enrolled in this study, 10 in the intervention group and 11 in the control group']","['Online Mindfulness Intervention', 'mindfulness intervention or routine prenatal care', 'online mindfulness intervention']","['depressive and anxious symptoms', 'mindfulness skills (eg, attention monitoring and acceptance', 'feasibility and acceptability', 'Generalized Anxiety Disorder Scale, the Patient Health Questionnaire', 'retention rate and feedback']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0222045'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",123.0,0.0257761,"Participants in the intervention group showed greater declines in depressive and anxious symptoms compared with those in the control group, as well a significant improvement in mindfulness skills (eg, attention monitoring and acceptance).
","[{'ForeName': 'Mengye', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Ge', 'Initials': 'G', 'LastName': 'Jia', 'Affiliation': ''}, {'ForeName': 'Shiwen', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Cuiwei', 'Initials': 'C', 'LastName': 'Ye', 'Affiliation': ''}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': ''}]",Journal of midwifery & women's health,['10.1111/jmwh.12944']
1302,31633603,The role of goal-directed therapy in the prevention of acute kidney injury after major gastrointestinal surgery: Substudy of the OPTIMISE trial.,"BACKGROUND


Acute kidney injury (AKI) is an important adverse outcome after major surgery. Peri-operative goal-directed haemodynamic therapy (GDT) may improve outcomes by reducing complications such as AKI.
OBJECTIVE


To determine if GDT was associated with a reduced incidence of postoperative AKI according to specific renal biomarkers.
DESIGN


Prospective substudy of the OPTIMISE trial, a multicentre randomised controlled trial comparing peri-operative GDT to usual patient care.
SETTING


Four UK National Health Service hospitals.
PATIENTS


A total of 287 high-risk patients aged at least 50 years undergoing major gastrointestinal surgery.
OUTCOME MEASURES


The primary outcome measure was AKI defined as urinary neutrophil gelatinase-associated lipase (NGAL) at least 150 ng ml 24 and 72 h after surgery. Secondary outcomes were between-group differences in NGAL measurements and NGAL : creatinine ratios 24 and 72 h after surgery and AKI stage 2 or greater according to Kidney Disease Improving Global Outcomes (KDIGO) criteria within 30 days of surgery.
RESULTS


In total, 20 of 287 patients (7%) experienced postoperative AKI of KDIGO grade 2 or 3 within 30 days. The proportion of patients with urinary NGAL at least 150 ng ml 24 or 72 h after surgery was similar in the two groups [GDT 31/144 (21.5%) patients vs. usual patient care 28/143 (19.6%) patients; P = 0.88]. Absolute values of urinary NGAL were also similar at 24 h (GDT 53.5 vs. usual patient care 44.1 ng ml; P = 0.38) and 72 h (GDT 45.1 vs. usual patient care 41.1 ng ml; P = 0.50) as were urinary NGAL : creatinine ratios at 24 h (GDT 45 vs. usual patient care 43 ng mg; P = 0.63) and 72 h (GDT 66 vs. usual patient care 63 ng mg; P = 0.62). The incidence of KDIGO-defined AKI was also similar between the groups [GDT 9/144 (6%) patients vs. usual patient care 11/143 (8%) patients; P = 0.80].
CONCLUSION


In this trial, GDT did not reduce the incidence of AKI amongst high-risk patients undergoing major gastrointestinal surgery. This may reflect improving standards in usual patient care.
TRIAL REGISTRATION


OPTIMISE Trial Registration ISRCTN04386758.",2019,"In this trial, GDT did not reduce the incidence of AKI amongst high-risk patients undergoing major gastrointestinal surgery.","['risk patients undergoing major gastrointestinal surgery', '287 high-risk patients aged at least 50 years undergoing major gastrointestinal surgery', 'acute kidney injury after major gastrointestinal surgery', 'Four UK National Health Service hospitals']","['Peri-operative goal-directed haemodynamic therapy (GDT', 'GDT', 'peri-operative GDT']","['postoperative AKI', 'NGAL measurements and NGAL\u200a:\u200acreatinine ratios 24 and 72\u200ah after surgery and AKI stage 2 or greater according to Kidney Disease Improving Global Outcomes (KDIGO) criteria', 'incidence of KDIGO-defined AKI', 'proportion of patients with urinary NGAL', 'Absolute values of urinary NGAL', 'AKI defined as urinary neutrophil gelatinase-associated lipase (NGAL']","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal Surgical Procedure'}, {'cui': 'C4517682', 'cui_str': '287 (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206528', 'cui_str': 'Gelatinases'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}]",287.0,0.516856,"In this trial, GDT did not reduce the incidence of AKI amongst high-risk patients undergoing major gastrointestinal surgery.","[{'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'MacDonald', 'Affiliation': 'From the Department of Peri-operative Medicine and Pain, Royal London Hospital, London, UK (NM), UCD School of Medicine (PTM, PD), Clinical Research Centre, UCD School of Medicine, University College Dublin, Dublin, Ireland (RI) and William Harvey Research Institute, Queen Mary University of London, Charterhouse Square, London, UK (RMP, JRP).'}, {'ForeName': 'Rupert M', 'Initials': 'RM', 'LastName': 'Pearse', 'Affiliation': ''}, {'ForeName': 'Patrick T', 'Initials': 'PT', 'LastName': 'Murray', 'Affiliation': ''}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Inzitari', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Doran', 'Affiliation': ''}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Prowle', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001104']
1303,31644512,Laryngeal Mask Airway Supreme vs. the Spritztube tracheal cannula in anaesthetised adult patients: A randomised controlled trial.,"BACKGROUND


The Spritztube is a new supraglottic airway device combining the ability to allow extraglottic ventilation of the lungs with the opportunity to perform fibreoptic-assisted intubation.
OBJECTIVES


To compare the Spritztube tracheal cannula with the Laryngeal Mask Airway Supreme (LMA-S) in anaesthetised adult patients.
DESIGN


A single-centre, randomised controlled study.
SETTING


Tertiary hospital.
PATIENTS


Mechanically ventilated patients undergoing elective surgery in the supine position under general anaesthesia were included. Main exclusion criteria were a history of, or predicted, difficult airway management according to SIAARTI guidelines and absence of written informed consent.
INTERVENTIONS


Patients received the LMA-S or Spritztube tracheal cannula to facilitate ventilation of the lungs.
MAIN OUTCOME MEASURES


Successful placement (primary outcome), time required for insertion, number of attempts, subjective assessment of ease of insertion, safety and incidence of complications were recorded.
RESULTS


One hundred and sixty seven patients were allocated to the LMA-S or Spritztube group, respectively, a total of 334 patients. In the LMA-S group, the device insertion failed in nine patients, compared with none in the Spritztube group (P = 0.002). Spritztube insertion was easy in 100% of cases compared with 94.6% of the cases in the LMA-S group (P = 0.03). The number of attempts was significantly higher with the LMA-S compared with the Spritztube (P = 0.0007), whereas the insertion times were comparable (P = 0.06). Except for the incidence of blood-staining, which was higher in the LMA-S group (P = 0.01), the number of complications was comparable in the two groups.
CONCLUSION


The Spritztube was as effective as the LMA-S in maintaining the airway with all patients being successfully ventilated without difficulty. The success rate of achieving a patent airway was comparable between the groups, with a similar occurrence of complications.
TRIAL REGISTRATION


NCT03443219.",2019,The Spritztube was as effective as the LMA-S in maintaining the airway with all patients being successfully ventilated without difficulty.,"['Tertiary hospital', 'Mechanically ventilated patients undergoing elective surgery in the supine position under general anaesthesia were included', 'anaesthetised adult patients', 'One hundred and sixty seven patients']","['LMA-S or Spritztube', 'Laryngeal Mask Airway Supreme™ vs. the Spritztube® tracheal cannula', 'LMA-S or Spritztube tracheal cannula to facilitate ventilation of the lungs', 'Spritztube tracheal cannula with the Laryngeal Mask Airway Supreme (LMA-S']","['incidence of blood-staining', 'time required for insertion, number of attempts, subjective assessment of ease of insertion, safety and incidence of complications', 'success rate of achieving a patent airway', 'number of complications', 'number of attempts']","[{'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0038846', 'cui_str': 'Dorsal Position'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C3282376', 'cui_str': 'Supreme'}, {'cui': 'C2945595', 'cui_str': 'Tracheal (qualifier value)'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0005768'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030650', 'cui_str': 'Patent'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}]",334.0,0.107823,The Spritztube was as effective as the LMA-S in maintaining the airway with all patients being successfully ventilated without difficulty.,"[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'De Rosa', 'Affiliation': 'From the Department of Anaesthesiology and Intensive Care, San Bortolo Hospital, Vicenza (SDR, AR, AP, EB, PG, VU, AP, RB, SCC), Department of Anaesthesia and Intensive Care Medicine, Maggiore Della Carità University Hospital, Novara (AM, DC) and Anesthesia and Intensive Care, AOU Policlinico Vittorio Emanuele, Catania, Italy (MS).'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Messina', 'Affiliation': ''}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Sorbello', 'Affiliation': ''}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rigobello', 'Affiliation': ''}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Colombo', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Piccolo', 'Affiliation': ''}, {'ForeName': 'Efrem', 'Initials': 'E', 'LastName': 'Bonaldi', 'Affiliation': ''}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Gennaro', 'Affiliation': ''}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Urukalo', 'Affiliation': ''}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Pellizzari', 'Affiliation': ''}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Bonato', 'Affiliation': ''}, {'ForeName': 'Stefano Checcacci', 'Initials': 'SC', 'LastName': 'Carboni', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001106']
1304,32407919,Application of a Microsurgical Space Restrictor in Microsurgical Simulation Training.,"OBJECTIVE


To investigate the effect of the application of a microsurgical space restrictor in microsurgical simulation training.
METHODS


A microsurgical space restrictor that can restrict the operation space was designed and produced. Forty neurosurgery residents with standardized training were selected as the study subjects and were randomly divided into the experimental group (group A) and the control group (group B). Group A was trained using the space restrictor, and group B was trained using the traditional method. The skills and overall performance of the two groups of trainees were assessed by the Stanford Microsurgery and Resident Training (SMaRT) scale. The assessment was divided into two stages: the unobstructed microsurgery test and the test with the microsurgical operation space restrictor.
RESULTS


In group A, the score for the first stage (A1) was 3.9 ± 0.6, the score for the second stage (A2) was 3.4 ± 0.6, and the score for A1 was better than that for A2 (P = 0.000); in group B, the score for the first stage (B1) was 3.57 ± 0.6, the score for the second stage (B2) was 3.0 ± 0.6, and the score for B1 was better than that for B2 (P = 0.000). Overall, the score for A1 was better than that for B1 (P = 0.046), and the score for A2 was better than that for B2 (P = 0.009).
CONCLUSION


Microsurgical space restrictor use can improve the effect of microsurgical simulation training and help trainees better master microsurgical operation skills.",2020,"Overall, the score for A1 was better than that for B1 (P = 0.046), and the score for A2 was better than that for B2 (P = 0.009).
",['Forty neurosurgery residents with standardized training were selected as the study subjects'],"['microsurgical simulation training', 'Microsurgical Space Restrictor']",['Stanford Microsurgery and Resident Training (SMaRT) scale'],"[{'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}]","[{'cui': 'C0026035', 'cui_str': 'Microsurgery'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",40.0,0.0137644,"Overall, the score for A1 was better than that for B1 (P = 0.046), and the score for A2 was better than that for B2 (P = 0.009).
","[{'ForeName': 'Zuowei', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Neurospine center, China International Neuroscience Institute, Beijing, People's Republic of China, 100053; Department of Neurosurgery, Education Department, Beijing Hospital, National Center of Gerontology, Beijing, People's Republic of China, 100730.""}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosurgery, Education Department, Beijing Hospital, National Center of Gerontology, Beijing, People's Republic of China, 100730.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Kong', 'Affiliation': ""Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Neurospine center, China International Neuroscience Institute, Beijing, People's Republic of China, 100053.""}, {'ForeName': 'Zan', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ""Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Neurospine center, China International Neuroscience Institute, Beijing, People's Republic of China, 100053.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Neurospine center, China International Neuroscience Institute, Beijing, People's Republic of China, 100053.""}, {'ForeName': 'Xingwen', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Neurospine center, China International Neuroscience Institute, Beijing, People's Republic of China, 100053.""}, {'ForeName': 'Fengzeng', 'Initials': 'F', 'LastName': 'Jian', 'Affiliation': ""Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Neurospine center, China International Neuroscience Institute, Beijing, People's Republic of China, 100053. Electronic address: jianfengzeng@xwh.ccmu.edu.cn.""}]",World neurosurgery,['10.1016/j.wneu.2020.05.031']
1305,32408011,"Cold versus hot adenoidectomy: A prospective, randomized controlled trial.","OBJECTIVE


Adenoidectomy can be performed using the cold method (mainly adenoid curettes) or the hot method (suction diathermy). Both techniques have similar intra and postoperative outcomes. However, the long-term clinical outcome of improving sleep disorder symptoms has not been well established. The objective of this study was to compare outcomes of hot method and cold method adenoidectomy one year following the surgery.
STUDY DESIGN


A prospective, randomized, single-blinded study of children under age 16 years who underwent adenoidectomy during the years 2014-2017. Patients were randomized to hot or cold adenoidectomy techniques.
SETTING


A tertiary health care referral center.
SUBJECTS AND METHODS


The final analysis included 58 children, mean age 5.9 years (range 1.2-15). The primary outcome was change in the Pediatric Sleep Questionnaire (PSQ) scores one month and one year after surgery. The secondary outcome was complication rate.
RESULTS


Clinical and demographic parameters were similar between the patients in the hot method group (n = 30) and the cold method group (n = 28). Adenoid size and estimated bleeding were similar between the groups. At one month after surgery, PSQ score was improved by a mean + 0.31 in the hot method group compared to +0.32 in the cold method group (p = 0.54). Improvement in PSQ scores was greater following hot than cold adenoidectomy at one year after surgery (+0.31 points vs. +0.22 points, p = 0.009).
CONCLUSION


Hot adenoidectomy is associated with better outcome than the cold technique, as reflected by PSQ scores one year after the surgery.",2020,"At one month after surgery, PSQ score was improved by a mean + 0.31 in the hot method group compared to +0.32 in the cold method group (p = 0.54).","['A tertiary health care referral center', 'children under age 16 years who underwent adenoidectomy during the years 2014-2017', '58 children, mean age 5.9 years (range 1.2-15']","['hot method and cold method adenoidectomy', 'Cold versus hot adenoidectomy', 'cold adenoidectomy', 'Hot adenoidectomy', 'hot or cold adenoidectomy techniques']","['sleep disorder symptoms', 'Pediatric Sleep Questionnaire (PSQ) scores', 'complication rate', 'PSQ scores', 'PSQ score', 'Adenoid size and estimated bleeding']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001425', 'cui_str': 'Adenoid excision'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4068880', 'cui_str': '1.2'}]","[{'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0001425', 'cui_str': 'Adenoid excision'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0426463', 'cui_str': 'Adenoids size'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",58.0,0.101449,"At one month after surgery, PSQ score was improved by a mean + 0.31 in the hot method group compared to +0.32 in the cold method group (p = 0.54).","[{'ForeName': 'Shorook', 'Initials': 'S', 'LastName': ""Na'ara"", 'Affiliation': 'The Laboratory for Applied Cancer Research, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel; Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Waseem', 'Initials': 'W', 'LastName': 'Sayegh', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Waseem', 'Initials': 'W', 'LastName': 'Nassar', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Shinnawi', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Ziv', 'Initials': 'Z', 'LastName': 'Gil', 'Affiliation': 'The Laboratory for Applied Cancer Research, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel; Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Gordin', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel. Electronic address: a_gordin@rambam.health.gov.il.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110087']
1306,32408022,Supporting Syrian families displaced by armed conflict: A pilot randomized controlled trial of the Caregiver Support Intervention.,"BACKGROUND


The impact of armed conflict and displacement on children's mental health is strongly mediated by compromised parenting stemming from persistently high caregiver stress. Parenting interventions for refugees emphasize the acquisition of parenting knowledge and skills, while overlooking the deleterious effects of chronic stress on parenting. War Child Holland's Caregiver Support Intervention (CSI) aims to strengthen parenting by lowering stress and improving psychosocial wellbeing among refugee parents, while also increasing knowledge and skill related to positive parenting. The CSI is a nine-session group intervention delivered by non-specialist providers.
OBJECTIVE


We describe the findings of a two-arm pilot randomized controlled trial of the CSI with Syrian refugees in Lebanon. The primary aim was to test the feasibility of our study methodology prior to conducting a definitive RCT.
METHODS


We recruited 78 families (151 parents), who were randomized to the CSI or a waitlist control group. Data were collected at baseline and post-intervention.
RESULTS


Randomization was successful, retention was high (99 %), as was intervention completion (95 % among women, 86 % among men). Implementation fidelity was excellent. Blinding was largely, though not completely effective. The CSI group showed significantly increased parental warmth and responsiveness, decreased harsh parenting, lowered stress and distress, improved psychosocial wellbeing, and improved stress management. CSI parents reported increased child psychosocial wellbeing. Control families showed no significant change on any variable.
CONCLUSIONS


Findings demonstrate the feasibility of our methodology for a definitive RCT, and suggest that the CSI shows promise as a scalable approach to strengthening parenting in refugee communities. Trial registration # ISRCTN33665023.",2020,"The CSI group showed significantly increased parental warmth and responsiveness, decreased harsh parenting, lowered stress and distress, improved psychosocial wellbeing, and improved stress management.","['78 families (151 parents', ""children's mental health""]","['CSI', 'Caregiver Support Intervention', ""War Child Holland's Caregiver Support Intervention (CSI""]","['parental warmth and responsiveness, decreased harsh parenting, lowered stress and distress, improved psychosocial wellbeing, and improved stress management', 'child psychosocial wellbeing']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0150162', 'cui_str': 'Caregiver support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043027', 'cui_str': 'War'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",78.0,0.126032,"The CSI group showed significantly increased parental warmth and responsiveness, decreased harsh parenting, lowered stress and distress, improved psychosocial wellbeing, and improved stress management.","[{'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Miller', 'Affiliation': 'War Child Holland, Helmholtzstraat 61g, 1098LE Amsterdam, The Netherlands. Electronic address: Kenneth.Miller@warchild.nl.'}, {'ForeName': 'Gabriela V', 'Initials': 'GV', 'LastName': 'Koppenol-Gonzalez', 'Affiliation': 'War Child Holland, Helmholtzstraat 61g, 1098LE Amsterdam, The Netherlands. Electronic address: Gabriela.Koppenol@warchild.nl.'}, {'ForeName': 'Maguy', 'Initials': 'M', 'LastName': 'Arnous', 'Affiliation': 'War Child Holland, Lebanon. Electronic address: Maguy.Arnous@warchild.nl.'}, {'ForeName': 'Fadila', 'Initials': 'F', 'LastName': 'Tossyeh', 'Affiliation': 'War Child Holland, Lebanon. Electronic address: Fadila.Tossyeh@warchild.nl.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Harvard University, United States. Electronic address: Alexandra.chen@post.harvard.edu.'}, {'ForeName': 'Nayla', 'Initials': 'N', 'LastName': 'Nahas', 'Affiliation': 'University of Balamand, Lebanon. Electronic address: Nayla.Nahas@balamand.edu.lb.'}, {'ForeName': 'Mark J D', 'Initials': 'MJD', 'LastName': 'Jordans', 'Affiliation': 'War Child Holland, Helmholtzstraat 61g, 1098LE Amsterdam, The Netherlands; Amsterdam Institute of Social Science Research, University of Amsterdam, The Netherlands. Electronic address: Mark.Jordans@warchild.nl.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104512']
1307,31376435,"Prospective, Randomized, Phase II, Non-Inferiority Study to Evaluate the Safety and Efficacy of Topical Thrombin (Human) Grifols as Adjunct to Hemostasis During Vascular, Hepatic, Soft Tissue, and Spinal Open Surgery.","BACKGROUND


Thrombin-based formulations have been used for topical hemostasis in surgery for decades. However, the number of randomized clinical trials comparing bovine vs human thrombin is limited.
STUDY DESIGN


A randomized, double-blind, non-inferiority phase II study evaluated the hemostatic efficacy and safety of plasma-derived topical thrombin (human) Grifols (TTH-Grifols; Instituto Grifols SA) vs bovine THROMBIN JMI (BT-JMI; GenTrac Inc) (2:1 ratio) in vascular, hepatic, soft tissue, and spinal operations. The primary efficacy end point was the percentage of patients achieving hemostasis at target bleeding sites with mild to moderate bleeding (response) within 5 minutes (T 5 ) of treatment application. Non-inferiority was met if the lower limit of the 95% CI of the response ratio of TTH-Grifols relative to BT-JMI by T 5  exceeded 0.8. Secondary efficacy variables were the cumulative response by 3 and 4 minutes (T 3  and T 4 ), and the number of treatment failures. Safety parameters were assessed.
RESULTS


Randomized patients in TTH-Grifols and BT-JMI groups were n = 137 and n = 68, respectively. In modified intention-to-treat population, rates of hemostasis by T 5  were 78.3% (94 of 120) in TTH-Grifols and 80.3% (49 of 61) in BT-JMI (response ratio: 0.973; 95% CI 0.833 to 1.135). Rates of hemostasis in vascular, hepatic, soft tissue, and spinal operations ranged from 75.0% to 82.5% for TTH-Grifols and from 54.5% to 91.7% for BT-JMI. No significant differences in adverse events were observed between treatment groups. Antibodies to bovine factor V antigen were detected in 2 patients exposed to BT-JMI and in none exposed to TTH-Grifols.
CONCLUSIONS


The TTH-Grifols was safe and well tolerated as a local hemostatic agent and was non-inferior to BT-JMI. No antibodies to thrombin developed in TTH-Grifols-treated patients.",2019,"CONCLUSIONS


TTH-Grifols was safe and well tolerated as a local hemostatic agent and was non-inferior to BT-JMI.",[],"['plasma-derived Topical Thrombin (Human) Grifols (TTH-Grifols) vs. Bovine Thrombin JMI® (BT-JMI', 'bovine vs. human thrombin', 'Topical Thrombin (Human) Grifols']","['Rates of hemostasis in vascular, hepatic, soft tissue, and spinal surgeries', 'rates of hemostasis', 'adverse events', 'antibodies to thrombin', 'safe and well tolerated', 'cumulative response', 'percentage of patients achieving hemostasis at target bleeding sites with mild-moderate bleeding (response', 'number of treatment failures']",[],"[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0863178', 'cui_str': 'Thrombin'}, {'cui': 'C1337342', 'cui_str': 'Bovine thrombin'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0863178', 'cui_str': 'Thrombin'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0162643'}]",,0.119924,"CONCLUSIONS


TTH-Grifols was safe and well tolerated as a local hemostatic agent and was non-inferior to BT-JMI.","[{'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Minkowitz', 'Affiliation': 'Anesthesia Department, Memorial Hermann-Memorial City Medical Center, Houston, TX. Electronic address: harold@minkowitzMD.com.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Navarro-Puerto', 'Affiliation': 'Grifols Bioscience Research Group, Grifols, Barcelona, Spain.'}, {'ForeName': 'Shankar', 'Initials': 'S', 'LastName': 'Lakshman', 'Affiliation': 'Lotus Clinical Research, Pasadena, CA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Singla', 'Affiliation': 'Lotus Clinical Research, Pasadena, CA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Cousar', 'Affiliation': 'River City Clinical Research, Jacksonville, FL.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Kim', 'Affiliation': 'University of Utah Hospital, Salt Lake City, UT.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Villavicencio', 'Affiliation': 'Boulder Neurosurgical and Spine Associates, Boulder, CO.'}, {'ForeName': 'Levester', 'Initials': 'L', 'LastName': 'Kirksey', 'Affiliation': 'Cleveland Clinic Heart and Vascular Institute, Cleveland, OH.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Ayguasanosa', 'Affiliation': 'Grifols Bioscience Research Group, Grifols, Barcelona, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2019.07.008']
1308,32408038,Does eccentric-concentric resistance training improve early functional outcomes compared to concentric resistance training after total knee arthroplasty?,"BACKGROUND


Total knee arthroplasty (TKA) is the preferred surgical treatment of end stage osteoarthritis of the knee. However, up to 20% of patients are dissatisfied after TKA. Moreover, kinesiophobia is negatively correlated with functional outcomes.
RESEARCH QUESTION


The aim of this study was to compare the effects of combined concentric-eccentric versus concentric program on muscular strength assessment and quality of life, after total knee arthroplasty in elderly people.
METHOD


A prospective study including 20 subjects (72.1 ± 6.3 years), following a rehabilitation program after TKA was performed. Subjects were randomized in combined eccentricconcentric (ECC-CON, n = 10) versus concentric (CN, n = 10) early rehabilitation protocols. There were no significant differences between groups with respect to demographic data. Data were collected before and after protocol: performance-based physical function (timed up and go test, 10-meter walk test, isokinetic assessment), Selfreported physical function and quality of life (Lequesne-ISK, WOMAC, OAKHQOL) and kinesiophobia assessment (TSK-CF). The Gaussian distribution for the whole population of this study was tested by a Kolmogorov-Smirnov test. Statistical analysis was performed using non-parametric Mann-Whitney U or Fisher's exact probability test, as appropriate.
RESULTS AND CONCLUSION


Performance-based physical function tests showed a significant improvement after early rehabilitation in the ECC-CON group for timed up and go (p = 0.0002) and 10-meter walk test (p = 0.001). Operated hamstring muscle peak torque was significantly improved in the ECC-CON group (p = 0.03). Self-reported physical function and quality of life tests were significantly better in the ECC-CON group for ISK (p = 0.03) and WOMAC (p = 0.04). Self-reported kinesiophobia significantly decreased after rehabilitation in both groups (p = 0.01) whilst there were no differences between groups. Early combined eccentric-concentric rehabilitation after TKA appears to be associated with improved outcomes compared to classic concentric rehabilitation protocols, on both physical function and quality of life. This information is new. Assessment and care of kinesiophobia should be considered in rehabilitation protocols standards.",2020,Self-reported physical function and quality of life tests were significantly better in the ECC-CON group for ISK (p = 0.03) and WOMAC (p = 0.04).,"['elderly people', '20 subjects (72.1\u202f±\u202f6.3 years), following a rehabilitation program after TKA was performed']","['combined concentric-eccentric versus concentric program', 'Total knee arthroplasty (TKA', 'concentric resistance training', 'eccentric-concentric resistance training', 'combined eccentricconcentric (ECC-CON, n\u202f=\u202f10) versus concentric (CN, n\u202f=\u202f10) early rehabilitation protocols', 'ECC-CON']","['Self-reported kinesiophobia', 'physical function and quality of life', 'Operated hamstring muscle peak torque', 'performance-based physical function (timed up and go test, 10-meter walk test, isokinetic assessment), Selfreported physical function and quality of life ', 'muscular strength assessment and quality of life', 'Self-reported physical function and quality of life tests']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4077283', 'cui_str': '67Ga-ethylenecysteamine cysteine'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}]",20.0,0.023474,Self-reported physical function and quality of life tests were significantly better in the ECC-CON group for ISK (p = 0.03) and WOMAC (p = 0.04).,"[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Teissier', 'Affiliation': 'Université Paris, Laboratoire de Biologie Bioingénierie et Bioimagerie Ostéo-Articulaire (B3OA), UMR CNRS 7052, INSERM U1273, 10 Av de Verdun, 75010, Paris, France; Department of Orthopaedic Surgery, Hospital Cochin, APHP, Université Paris 5, Paris, France. Electronic address: vic.teissier@gmail.com.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Leclercq', 'Affiliation': ""Université d'Orléans, COST, 45100, Orléans, France. Electronic address: apa.olivet@orpea.net.""}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Schiano-Lomoriello', 'Affiliation': 'Université Orléans, CIAMS, 45067, Orléans, France; CIAMS, Université Paris-Sud, Université Paris-Saclay, 91405, Orsay Cedex, France. Electronic address: sandrine.schiano-lomoriello@univ-orleans.fr.'}, {'ForeName': 'Rémy', 'Initials': 'R', 'LastName': 'Nizard', 'Affiliation': 'Université Paris, Laboratoire de Biologie Bioingénierie et Bioimagerie Ostéo-Articulaire (B3OA), UMR CNRS 7052, INSERM U1273, 10 Av de Verdun, 75010, Paris, France; 6-AP-HP, Hôpital Lariboisière, Service de chirurgie orthopédique, F-75010, Paris, France. Electronic address: remy.nizard@aphp.fr.'}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Portier', 'Affiliation': ""Université Paris, Laboratoire de Biologie Bioingénierie et Bioimagerie Ostéo-Articulaire (B3OA), UMR CNRS 7052, INSERM U1273, 10 Av de Verdun, 75010, Paris, France; Université d'Orléans, COST, 45100, Orléans, France. Electronic address: hugues.portier@univ-orleans.fr.""}]",Gait & posture,['10.1016/j.gaitpost.2020.04.020']
1309,30509675,"Cefiderocol versus imipenem-cilastatin for the treatment of complicated urinary tract infections caused by Gram-negative uropathogens: a phase 2, randomised, double-blind, non-inferiority trial.","BACKGROUND


Carbapenem-resistant Gram-negative bacteria represent the highest priority for addressing global antibiotic resistance. Cefiderocol (S-649266), a new siderophore cephalosporin, has broad activity against Enterobacteriaceae and non-fermenting bacteria, such as Pseudomonas aeruginosa and Acinetobacter baumannii, including carbapenem-resistant strains. We assessed the efficacy and safety of cefiderocol versus imipenem-cilastatin for the treatment of complicated urinary tract infection in patients at risk of multidrug-resistant Gram-negative infections.
METHODS


We did a phase 2, multicentre, double-blind, parallel-group non-inferiority trial at 67 hospitals in 15 countries. Adults (≥18 years) admitted to hospital with a clinical diagnosis of complicated urinary tract infection with or without pyelonephritis or those with acute uncomplicated pyelonephritis were randomly assigned (2:1) by an interactive web or voice response system to receive 1 h intravenous infusions of cefiderocol (2 g) or imipenem-cilastatin (1 g each) three times daily, every 8 h for 7-14 days. Patients were excluded if they had a baseline urine culture with more than two uropathogens, a fungal urinary tract infection, or pathogens known to be carbapenem resistant. The primary endpoint was the composite of clinical and microbiological outcomes at test of cure (ie, 7 days after treatment cessation), which was used to establish non-inferiority (15% and 20% margins) of cefiderocol versus imipenem-cilastatin. The primary efficacy analysis was done on a modified intention-to-treat population, which included all randomly assigned individuals who received at least one dose of study drug and had a qualifying Gram-negative uropathogen (≥1 × 10 5  colony-forming units [CFU]/mL). Safety was assessed in all randomly assigned individuals who received at least one dose of study drug, according to the treatment they received. This study is registered with ClinicalTrials.gov, number NCT02321800.
FINDINGS


Between Feb 5, 2015, and Aug 16, 2016, 452 patients were randomly assigned to cefiderocol (n=303) or imipenem-cilastatin (n=149), of whom 448 patients (n=300 in the cefiderocol group; n=148 in the imipenem-cilastatin group) received treatment. 371 patients (n=252 patients in the cefiderocol group; n=119 patients in the imipenem-cilastatin group) had qualifying Gram-negative uropathogen (≥1 × 10 5  CFU/mL) and were included in the primary efficacy analysis. At test of cure, the primary efficacy endpoint was achieved by 183 (73%) of 252 patients in the cefiderocol group and 65 (55%) of 119 patients in the imipenem-cilastatin group, with an adjusted treatment difference of 18·58% (95% CI 8·23-28·92; p=0·0004), establishing the non-inferiority of cefiderocol. Cefiderocol was well tolerated. Adverse events occurred in 122 (41%) of 300 patients in the cefiderocol group and 76 (51%) of 148 patients in the imipenem-cilastatin group, with gastrointestinal disorders (ie, diarrhoea, constipation, nausea, vomiting, and abdominal pain) the most common adverse events for both treatment groups (35 [12%] patients in the cefiderocol group and 27 [18%] patients in the imipenem-cilastatin group).
INTERPRETATION


Intravenous infusion of cefiderocol (2 g) three times daily was non-inferior compared with imipenem-cilastatin (1 g each) for the treatment of complicated urinary tract infection in people with multidrug-resistant Gram-negative infections. The results of this study will provide the basis for submission of a New Drug Application to the US Food and Drug Administration. Clinical trials of hospital-acquired pneumonia and carbapenem-resistant infections are ongoing.
FUNDING


Shionogi & Co Ltd, Shionogi Inc.",2018,three times daily was non-inferior compared with imipenem-cilastatin (1 g each) for the treatment of complicated urinary tract infection in people with multidrug-resistant Gram-negative infections.,"['patients at risk of multidrug-resistant Gram-negative infections', '371 patients (n=252 patients in the cefiderocol group; n=119 patients in the', '67 hospitals in 15 countries', 'n=149), of whom 448 patients (n=300 in the cefiderocol group; n=148 in the', 'Adults (≥18 years) admitted to hospital with a clinical diagnosis of complicated urinary tract infection with or without pyelonephritis or those with acute uncomplicated pyelonephritis', 'Patients were excluded if they had a baseline urine culture with more than two uropathogens, a fungal urinary tract infection, or pathogens known to be carbapenem resistant', 'group) had qualifying Gram-negative uropathogen (≥1', 'people with multidrug-resistant Gram-negative infections', '452 patients']","['cefiderocol (2 g', 'Cefiderocol', 'cefiderocol', 'cefiderocol versus imipenem-cilastatin', 'imipenem-cilastatin', 'Cefiderocol (S-649266', 'interactive web or voice response system to receive 1 h intravenous infusions of cefiderocol (2 g) or imipenem-cilastatin (1 g each', 'Cefiderocol versus imipenem-cilastatin']","['Adverse events', 'tolerated', 'gastrointestinal disorders (ie, diarrhoea, constipation, nausea, vomiting, and abdominal pain', 'efficacy and safety', 'composite of clinical and microbiological outcomes at test of cure', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C4548369', 'cui_str': 'cefiderocol'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C4552431', 'cui_str': 'Complicated urinary tract infection'}, {'cui': 'C0034186', 'cui_str': 'Pyelonephritis'}, {'cui': 'C4524264', 'cui_str': 'Uncomplicated pyelonephritis'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0430404', 'cui_str': 'Urine culture (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}]","[{'cui': 'C4548369', 'cui_str': 'cefiderocol'}, {'cui': 'C0071972', 'cui_str': 'Cilastatin / Imipenem'}, {'cui': 'C4548370', 'cui_str': 'S-649266'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",452.0,0.570167,three times daily was non-inferior compared with imipenem-cilastatin (1 g each) for the treatment of complicated urinary tract infection in people with multidrug-resistant Gram-negative infections.,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Portsmouth', 'Affiliation': 'Shionogi Inc, Florham Park, NJ, USA. Electronic address: simon.portsmouth@shionogi.com.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'van Veenhuyzen', 'Affiliation': 'Shionogi Inc, Florham Park, NJ, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Echols', 'Affiliation': 'ID3C, Easton, CT, USA.'}, {'ForeName': 'Mitsuaki', 'Initials': 'M', 'LastName': 'Machida', 'Affiliation': 'Shionogi & Co Ltd, Osaka, Japan.'}, {'ForeName': 'Juan Camilo Arjona', 'Initials': 'JCA', 'LastName': 'Ferreira', 'Affiliation': 'Shionogi Inc, Florham Park, NJ, USA.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Ariyasu', 'Affiliation': 'Shionogi & Co Ltd, Osaka, Japan.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Tenke', 'Affiliation': 'Department of Urology, Jahn Ferenc Dél-Pesti Hospital, Budapest, Hungary.'}, {'ForeName': 'Tsutae Den', 'Initials': 'TD', 'LastName': 'Nagata', 'Affiliation': 'Shionogi & Co Ltd, Osaka, Japan.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30554-1']
1310,30888253,The effect of selenium and zinc on CD4(+) count and opportunistic infections in HIV/AIDS patients: a randomized double blind trial.,"Objectives : We assessed the effect of selenium and zinc supplementation on CD4 cell count and the risk of developing opportunistic infections. Methods : In a double blind clinical trial, 146 HIV(+) patients receiving combination antiretroviral therapy with CD4(+) >200/cubic millimeter were screened for comorbidities and opportunistic infections, and randomized to receive daily selenium (200 µg), zinc (50 mg) or placebo for 6 months, before a 3-month follow-up period. CD4 cell counts were measured in the 3 th , 6 th  and 9 th  months. The serum selenium and zinc were measured in the 6 th  month. The incidence of opportunistic infection was assessed monthly for 6 months and at the end of the 9 th  month. Results : The final incidence of supplement deficiency for placebo, zinc and selenium were 46.7%, 44.7% and 50.0%, respectively. Overall compliance with supplementation was 99.42%. Although the changes from baseline were not statistically significant, zinc supplementation was significantly associated with reduced risk of opportunistic infections. Conclusion : Development of the opportunistic infections after zinc supplementation significantly decreased; however, significant improvement in CD4 count was not observed in this group.",2020,"Although the changes from baseline were not statistically significant, zinc supplementation was significantly associated with reduced risk of opportunistic infections.
","['HIV/AIDS patients', '146 HIV(+) patients receiving combination antiretroviral therapy with CD4(+) >200/cubic millimeter were screened for comorbidities and opportunistic infections']","['selenium and zinc supplementation', 'selenium and zinc', 'daily selenium (200\xa0µg), zinc (50\xa0mg) or placebo']","['CD4(+) count and opportunistic infections', 'CD4 count', 'CD4 cell count and the risk of developing opportunistic infections', 'final incidence of supplement deficiency for placebo, zinc and selenium', 'Overall compliance', 'incidence of opportunistic infection', 'CD4 cell counts', 'serum selenium and zinc', 'risk of opportunistic infections']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439243', 'cui_str': 'mm3'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic Infections'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic Infections'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0858170', 'cui_str': 'Serum selenium'}]",146.0,0.548748,"Although the changes from baseline were not statistically significant, zinc supplementation was significantly associated with reduced risk of opportunistic infections.
","[{'ForeName': 'Azar', 'Initials': 'A', 'LastName': 'Hadadi', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Ostovar', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Edalat Noor', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehrnaz', 'Initials': 'M', 'LastName': 'Rasoolinejad', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahboobeh', 'Initials': 'M', 'LastName': 'Haji Abdolbaghi', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Yousefi', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Manshoori', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Khashayar', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Alipour', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Safari', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.'}]",Acta clinica Belgica,['10.1080/17843286.2019.1590023']
1311,31648099,"Patritumab or placebo, with cetuximab plus platinum therapy in recurrent or metastatic squamous cell carcinoma of the head and neck: A randomised phase II study.","BACKGROUND


The fully human monoclonal antibody patritumab blocks HER3 activation, a resistance mechanism to cetuximab, induced by heregulin (HRG). A phase Ib study in recurrent and/or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) demonstrated tolerability and tumour response of patritumab + cetuximab + platinum.
METHODS


This was a randomised, double-blind, phase II study of patritumab + cetuximab with platinum-based therapy for first-line treatment of R/M SCCHN (Clinicaltrials.gov identifier: NCT02633800). Patients aged ≥18 years received patritumab or placebo, both combined with cetuximab + cisplatin or carboplatin. Co-primary end-points were progression-free survival (PFS) in the intent-to-treat (ITT) and the high-expression HRG (HRG high) populations.
RESULTS


Eighty-seven patients (n = 43 in the patritumab group; n = 44 in placebo group) enrolled. A median (range) of 6.5 (1-24) patritumab cycles were completed. Median PFS was similar between the patritumab group and placebo group in the ITT population (5.6 versus 5.5 months; hazard ratio [HR] 0.99 [95% confidence interval [CI], 0.6-1.7]; P = 0.96) and HRG-high subgroup (n = 51; 5.6 versus 5.6 months; HR 0.93 [95% CI, 0.5-1.8]; P = 0.82). Median overall survival in the ITT population was also similar (10.0 versus 12.7 months; HR 1.3 [95% CI, 0.69-2.29]; P = 0.46). All patients experienced ≥1 treatment-emergent adverse event (TEAE). Grade ≥III TEAEs were more frequent in the patritumab than the placebo group (84.1% versus 60.5%). The most common grade ≥III patritumab-related TEAE in the patritumab group (20.5% overall) was rash (6.8%).
CONCLUSION


Patritumab + cetuximab + platinum was tolerable but not superior to cetuximab + platinum.",2019,"Median overall survival in the ITT population was also similar (10.0 versus 12.7 months; HR 1.3 [95% CI, 0.69-2.29]; P = 0.46).","['recurrent or metastatic squamous cell carcinoma of the head and neck', 'recurrent and/or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN', '43 in the patritumab group; n\xa0=\xa044 in placebo group) enrolled', 'Eighty-seven patients (n\xa0', 'Patients aged ≥18 years received']","['cetuximab plus platinum therapy', 'placebo', 'patritumab or placebo, both combined with cetuximab\xa0+\xa0cisplatin or carboplatin', 'Patritumab\xa0', 'Patritumab or placebo', 'patritumab\xa0+\xa0cetuximab with platinum-based therapy', 'cetuximab\xa0+\xa0platinum']","['Grade ≥III', 'progression-free survival (PFS', '≥1 treatment-emergent adverse event (TEAE', 'Median overall survival', 'Median PFS']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C3897976'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3897976'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",87.0,0.269585,"Median overall survival in the ITT population was also similar (10.0 versus 12.7 months; HR 1.3 [95% CI, 0.69-2.29]; P = 0.46).","[{'ForeName': 'Martin D', 'Initials': 'MD', 'LastName': 'Forster', 'Affiliation': 'Department of Oncology, UCL Cancer Institute/University College London Hospitals, London, UK.'}, {'ForeName': 'Magnus T', 'Initials': 'MT', 'LastName': 'Dillon', 'Affiliation': 'Head and Neck Unit, Royal Marsden Hospital/Institute of Cancer Research, National Institute of Health Research Biomedical Research Center, London, UK.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Kocsis', 'Affiliation': 'Oncology Department, Debrecen University Clinical Center, Debrecen, Hungary; Department of Oncoradiology, Bács-kiskun County Teaching Hospital (BKMK) Centre of Oncoradiology, Kecskemét, Hungary.'}, {'ForeName': 'Éva', 'Initials': 'É', 'LastName': 'Remenár', 'Affiliation': 'Hospitalier Order of Saint John of God Hospital Buda, Budapest, Hungary.'}, {'ForeName': 'Gabor', 'Initials': 'G', 'LastName': 'Pajkos', 'Affiliation': 'Department of Oncoradiology, Bács-kiskun County Teaching Hospital (BKMK) Centre of Oncoradiology, Kecskemét, Hungary.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Rolland', 'Affiliation': ""Department of Medical Oncology, Institut de Cancerologie de l'Ouest (ICO) - Site René Gauducheau, Saint-Herblain, France.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Greenberg', 'Affiliation': 'Research and Development Oncology, Daiichi Sankyo, Edison, NJ, USA.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Harrington', 'Affiliation': 'Head and Neck Unit, Royal Marsden Hospital/Institute of Cancer Research, National Institute of Health Research Biomedical Research Center, London, UK. Electronic address: Kevin.Harrington@icr.ac.uk.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.08.017']
1312,32408117,"Effects of saffron supplementation on glycemia and inflammation in patients with type 2 diabetes mellitus: A randomized double-blind, placebo-controlled clinical trial study.","BACKGROUND


New evidence indicates that overproduction of pro-inflammatory cytokines is responsible for the development of diabetes difficulties. Some herbals such as saffron, may control inflammation and improve the hyperglycemic states in diabetic patients. Therefore, this investigation aimed to assess the effects of saffron supplementation on fasting glucose and inflammatory markers levels in patients with type2 diabetes mellitus (T2DM).
METHODS


In this randomized double-blind, placebo-controlled clinical trial, 60 T2DM patients were randomly assigned into two groups as saffron and placebo (n = 30) receiving 100 mg/day saffron powder or starch capsules (1 capsule) for a duration of 8 weeks. Fasting blood sample was collected at baseline and at the end of the intervention. Fasting blood glucose (FBG) was immediately analyzed by the auto-analyzer. The serum level of Interleukin -6 (IL-6), Tumor necrosis factor-alpha (TNF-α), and Interleukin-10 (IL-10) were measured using ELISA assay by laboratory kits. Also, Real-time quantitative reverse transcription (RT-PCR) assay measured the expression level of TNF-α, IL-6, and IL-10 at the mRNA level.
RESULTS


Saffron supplementation significantly decreased the FBG levels within 8 weeks compared to placebo (130.93 ± 21.21 vs 135.13 ± 23.03 mg/dl, P = 0.012). Moreover, the serum level of TNF-α notably reduced in the saffron group compared to the placebo group (114.40 ± 24.28 vs 140.90 ± 25.49 pg/ml, P < 0.001). Also, saffron supplementation significantly down-regulated the expressions of TNF-α (P = 0.035) and IL-6 mRNA levels (P = 0.014).
CONCLUSION


In our study, it was indicated that saffron modulates glucose levels as well as inflammation status in T2DM patients through decreasing the expressions levels of some inflammatory mediators. Also, further investigations are necessary to confirm the positive effects of saffron as a complementary therapy for T2DM patients.",2020,"Also, saffron supplementation significantly down-regulated the expressions of TNF-α (P = 0.035) and IL-6 mRNA levels (P = 0.014).
","['60 T2DM patients', 'patients with type 2 diabetes mellitus', 'patients with type2 diabetes mellitus (T2DM', 'diabetic patients', 'T2DM patients']","['saffron supplementation', 'saffron and placebo (n\xa0=\xa030) receiving 100\xa0mg/day saffron powder or starch capsules', 'placebo']","['IL-6 mRNA levels', 'hyperglycemic states', 'glycemia and inflammation', 'Real-time quantitative reverse transcription (RT-PCR) assay measured the expression level of TNF-α, IL-6, and IL-10 at the mRNA level', 'FBG levels', 'expressions of TNF-α', 'fasting glucose and inflammatory markers levels', 'Fasting blood glucose (FBG', 'serum level of Interleukin\xa0-6 (IL-6), Tumor necrosis factor-alpha (TNF-α), and Interleukin-10 (IL-10', 'serum level of TNF-α', 'Fasting blood sample']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0162753', 'cui_str': 'Saffron Stain'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0035380', 'cui_str': 'Transcription, Reverse'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",60.0,0.491142,"Also, saffron supplementation significantly down-regulated the expressions of TNF-α (P = 0.035) and IL-6 mRNA levels (P = 0.014).
","[{'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mobasseri', 'Affiliation': 'Department of Medicine, Endocrine Section, Endocrine Research Center, Tabriz University of Medical Sciences, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ostadrahimi', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Aynaz', 'Initials': 'A', 'LastName': 'Tajaddini', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Pharmacology School of Medical Sciences, Faculty of Medicine, The University of New South Wales, Sydney, NSW, 2052, Australia.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Asghari', 'Affiliation': 'Stem Cell and Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Meisam', 'Initials': 'M', 'LastName': 'Barati', 'Affiliation': 'Student Research Committee, Department of Cellular and Molecular Nutrition, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Moloud', 'Initials': 'M', 'LastName': 'Akbarzadeh', 'Affiliation': 'Stem Cell and Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Nikpayam', 'Affiliation': 'Students Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Clinical Nutrition, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Jalil', 'Initials': 'J', 'LastName': 'Houshyar', 'Affiliation': 'Department of Medicine, Endocrine Section, Endocrine Research Center, Tabriz University of Medical Sciences, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Roshanravan', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: roshanravann@tbzmed.ac.ir.'}, {'ForeName': 'Naimeh Mesri', 'Initials': 'NM', 'LastName': 'Alamdari', 'Affiliation': 'Student Research Committee, Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: mesrialamdari.n@tak.iums.ac.ir.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.04.031']
1313,32408065,Spending the night next to a router - Results from the first human experimental study investigating the impact of Wi-Fi exposure on sleep.,"BACKGROUND


The use of wireless telecommunication systems such as wireless fidelity (Wi-Fi)-enabled devices has steadily increased in recent years. There are persistent concerns that radiofrequency electromagnetic field (RF-EMF) exposure might affect health. Possible effects of RF-EMF exposure on human sleep were examined with regard to mobile phones and base stations, but not with regard to Wi-Fi exposure.
OBJECTIVES


The present double-blind, sham-controlled, randomized, fully counterbalanced cross-over study addressed for the first time the question whether a whole night Wi-Fi exposure has an effect on sleep.
METHODS


Thirty-four healthy young male subjects (mean ± SD: 24.1 ± 2.9 years) spent five nights in the sleep laboratory. A screening and adaptation night was followed by two experimental nights. Each of the experimental nights was preceded by a baseline night. Sleep was evaluated at the subjective level by a questionnaire and at the objective level (macro- and microstructure) by polysomnography. Either 2.45 GHz Wi-Fi (max psSAR10g of 6.4 mW/kg) or sham signals were delivered by a newly developed head exposure facility.
RESULTS


Results showed no statistically significant acute effects of a whole-night Wi-Fi exposure on subjective sleep parameters as well as on parameters characterizing the macrostructure of sleep. Analyses of the microstructure of sleep revealed a reduction in global EEG power in the alpha frequency band (8.00-11.75 Hz) during NREM sleep under acute Wi-Fi exposure compared to sham.
DISCUSSION


The results of the present human experimental study are well in line with several other neurophysiological studies showing that acute RF-EMF exposure has no effect on the macrostructure of sleep. The slight physiological changes in EEG power observed under Wi-Fi exposure are neither reflected in the subjective assessment of sleep nor at the level of objective measurements. The present results are not indicative of a sleep disturbing effect of Wi-Fi exposure.",2020,"RESULTS


Results showed no statistically significant acute effects of a whole-night Wi-Fi exposure on subjective sleep parameters as well as on parameters characterizing the macrostructure of sleep.",['Thirty-four healthy young male subjects (mean\xa0±\xa0SD: 24.1\xa0±\xa02.9 years) spent five nights in the sleep laboratory'],"['GHz Wi-Fi', 'RF-EMF exposure', 'radiofrequency electromagnetic field (RF-EMF']","['subjective sleep parameters', 'global EEG power', 'Sleep']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0556961', 'cui_str': 'GHz'}, {'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",34.0,0.0200575,"RESULTS


Results showed no statistically significant acute effects of a whole-night Wi-Fi exposure on subjective sleep parameters as well as on parameters characterizing the macrostructure of sleep.","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Danker-Hopfe', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Competence Center for Sleep Medicine, Berlin, Germany. Electronic address: heidi.danker-hopfe@charite.de.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Bueno-Lopez', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Competence Center for Sleep Medicine, Berlin, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Dorn', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Competence Center for Sleep Medicine, Berlin, Germany.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Schmid', 'Affiliation': 'Seibersdorf Laboratories, 2444, Seibersdorf, Austria.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Hirtl', 'Affiliation': 'Seibersdorf Laboratories, 2444, Seibersdorf, Austria.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Eggert', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Competence Center for Sleep Medicine, Berlin, Germany.'}]",International journal of hygiene and environmental health,['10.1016/j.ijheh.2020.113550']
1314,30489352,The Effect of Acute Glutamine Supplementation on Markers of Inflammation and Fatigue During Consecutive Days of Simulated Wildland Firefighting.,"OBJECTIVE


To examine the effect of oral glutamine supplementation on inflammation and fatigue during and after simulated wildland firefighting (WLFF) tasks in hot conditions over 2 consecutive days.
METHODS


Eleven men and women ingested a glutamine supplement or a placebo before and after simulated wildland firefighting in an environmental chamber (38 °C, 35% relative humidity). Subjective fatigue, markers of inflammation, and cellular stress were measured pre, post and 4 hours post-exercise on both days.
RESULTS


Gastrointestinal damage, subjective fatigue, and ratings of perceived exertion were lower after glutamine supplementation compared with placebo. Heat shock protein 70 (HSP70) and nuclear factor kappa-inhibitor alpha (IκBα) levels were higher on both days of the glutamine trial compared with placebo.
CONCLUSIONS


Glutamine supplementation may improve recovery after fire suppression in WLFFs. This may result from the upregulation of HSP70 which inhibits inflammation and protects against gastrointestinal (GI) barrier damage.",2019,"Heat shock protein 70 (HSP70) and nuclear factor kappa-inhibitor alpha (IκBα) levels were higher on both days of the glutamine trial compared with placebo.
","['Eleven men and women ingested a', 'before and after simulated wildland firefighting in an environmental chamber (38\u200a°C, 35% relative humidity', 'hot conditions over 2 consecutive days']","['Acute Glutamine Supplementation', 'placebo', 'glutamine supplement or a placebo', 'oral glutamine supplementation', 'Glutamine supplementation']","['Heat shock protein 70 (HSP70) and nuclear factor kappa-inhibitor alpha (IκBα) levels', 'Markers of Inflammation and Fatigue', 'Subjective fatigue, markers of inflammation, and cellular stress', 'Gastrointestinal damage, subjective fatigue, and ratings of perceived exertion']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0428696', 'cui_str': 'Relative humidity (observable entity)'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0243043', 'cui_str': 'HSP70 Heat-Shock Proteins'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}]",11.0,0.196751,"Heat shock protein 70 (HSP70) and nuclear factor kappa-inhibitor alpha (IκBα) levels were higher on both days of the glutamine trial compared with placebo.
","[{'ForeName': 'Roberto C', 'Initials': 'RC', 'LastName': 'Nava', 'Affiliation': 'Department of Health, Exercise, and Sport Science, College of Education, Exercise Physiology Lab, Johnson Center B143 MSC04 2610, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Micah N', 'Initials': 'MN', 'LastName': 'Zuhl', 'Affiliation': ''}, {'ForeName': 'Terence A', 'Initials': 'TA', 'LastName': 'Moriarty', 'Affiliation': ''}, {'ForeName': 'Fabiano T', 'Initials': 'FT', 'LastName': 'Amorim', 'Affiliation': ''}, {'ForeName': 'Kelsey C', 'Initials': 'KC', 'LastName': 'Bourbeau', 'Affiliation': ''}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Welch', 'Affiliation': ''}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'McCormick', 'Affiliation': ''}, {'ForeName': 'Kelli E', 'Initials': 'KE', 'LastName': 'King', 'Affiliation': ''}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Mermier', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001507']
1315,30401602,The Effect of Preoperative Oral Carbohydrate Administration on Insulin Resistance and Comfort Level in Patients Undergoing Surgery.,"PURPOSE


The aim of this study was to evaluate the effect of preoperative oral carbohydrate solution (OCS) administration on postoperative insulin resistance and patient comfort in elective laparoscopic cholecystectomy.
DESIGN


Randomized controlled clinical study.
METHODS


The experimental group received OCS. The control group did not eat or drink before surgery. Glucose and insulin level were measured at baseline, 2 hours before surgery, and at the first and third hour after surgery. Insulin resistance was assessed by the homeostasis model assessment of insulin resistance (HOMA-IR). The visual analogue scale (VAS) and general comfort scale (GCS) were used to assess postoperative comfort level.
FINDINGS


A significant increase in the glucose level was observed in both groups (P < 0.05). A change in glucose level was significantly higher in the control group (P = .014). HOMA-IR values did not change significantly in the OCS group (P = .160). In the OCS group VAS scores were significantly lower (P < .0001). The OCS group had significantly higher relief (P = .014), ease (P = .001), and transcendence (P < .0001) scores.
CONCLUSIONS


OCS decreases insulin resistance and increases comfort.",2019,"The OCS group had significantly higher relief (P = .014), ease (P = .001), and transcendence (P < .0001) scores.
","['elective laparoscopic cholecystectomy', 'Patients Undergoing Surgery']","['preoperative oral carbohydrate solution (OCS', 'Preoperative Oral Carbohydrate Administration', 'control group did not eat or drink before surgery', 'OCS']","['Glucose and insulin level', 'Insulin resistance', 'postoperative insulin resistance and patient comfort', 'Insulin Resistance and Comfort Level', 'VAS scores', 'relief', 'HOMA-IR values', 'glucose level', 'insulin resistance and increases comfort', 'homeostasis model assessment of insulin resistance (HOMA-IR', 'visual analogue scale (VAS) and general comfort scale (GCS']","[{'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0566308', 'cui_str': 'Does not eat (finding)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}]",,0.0420731,"The OCS group had significantly higher relief (P = .014), ease (P = .001), and transcendence (P < .0001) scores.
","[{'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Onalan', 'Affiliation': ''}, {'ForeName': 'Isil I', 'Initials': 'II', 'LastName': 'Andsoy', 'Affiliation': ''}, {'ForeName': 'Omer F', 'Initials': 'OF', 'LastName': 'Ersoy', 'Affiliation': ''}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2018.07.007']
1316,32408361,22G Acquire vs. 20G Procore needle for endoscopic ultrasound-guided biopsy of pancreatic masses: a randomized study comparing histologic sample quantity and diagnostic accuracy.,"BACKGROUND : Endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) has been suggested for obtaining high quality tissue samples from pancreatic tumors. We performed a multicenter randomized crossover trial comparing EUS-FNB with a 20G Procore needle vs. a 22G Acquire needle. The aims were to compare the quantity of targeted tissue (pancreas) and diagnostic accuracy for the two needles. METHODS : 60 patients admitted for EUS-FNB in three endoscopy units were included. One pass was performed consecutively with each needle, in a randomized order. Histologic material was studied in a blinded manner with respect to the needle. The primary end point was mean cumulative length of tissue core biopsies per needle pass. RESULTS : Final diagnosis was adenocarcinoma (n = 46; 77 %), neuroendocrine neoplasm (n = 11; 18 %), autoimmune pancreatitis (n = 2), and mass-forming chronic pancreatitis (n = 1). The mean cumulative length of tissue core biopsies per needle pass was significantly higher with the 22G Acquire needle at 11.4 mm (95 % confidence interval [CI] 9.0 - 13.8] vs. 5.4 mm (95 %CI 3.8 - 7.0) for the 20G Procore needle ( P  < 0.001), as was the mean surface area (3.5 mm 2  [95 %CI 2.7 - 4.3] vs. 1.8 mm 2  [95 %CI 1.2 - 2.3];  P  < 0.001). Diagnostic adequacy and accuracy were 100 % and 87 % with the 22G Acquire needle, and 82 % and 67 % with the 20G Procore needle ( P  = 0.001 and  P  = 0.02, respectively). CONCLUSIONS : EUS-guided biopsy of pancreatic masses with the 22G Acquire needle provided more tissue for histologic evaluation and better diagnostic accuracy than the 20G Procore needle.",2020,EUS-guided biopsy of pancreatic masses with the 22G Acquire needle provided more tissue for histologic evaluation and better diagnostic accuracy than the 20G Procore needle.,['60 patients admitted for EUS-FNB in three endoscopy units were included'],"['Endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB', '22G Acquire vs. 20G Procore needle for endoscopic ultrasound-guided biopsy of pancreatic masses', 'EUS-FNB with a 20G Procore needle vs. a 22G Acquire needle']","['quantity of targeted tissue (pancreas) and diagnostic accuracy', 'Diagnostic adequacy and accuracy', 'autoimmune pancreatitis', 'mean cumulative length of tissue core biopsies per needle pass']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0085846', 'cui_str': 'Fine needle biopsy'}, {'cui': 'C0450404', 'cui_str': '22G'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0877425', 'cui_str': 'Mass of pancreas'}]","[{'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C2609129', 'cui_str': 'Autoimmune pancreatitis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1318309', 'cui_str': 'Core needle biopsy'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]",60.0,0.0430272,EUS-guided biopsy of pancreatic masses with the 22G Acquire needle provided more tissue for histologic evaluation and better diagnostic accuracy than the 20G Procore needle.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Karsenti', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique de Paris-Bercy, Charenton-le-Pont, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Palazzo', 'Affiliation': 'Digestive Endoscopy Unit, Clinique du Trocadéro, Paris, France.'}, {'ForeName': 'Bastien', 'Initials': 'B', 'LastName': 'Perrot', 'Affiliation': 'UMR1246_SPHERE Methods for Patient-Centered Outcomes and Health Research, Nantes University, France.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Zago', 'Affiliation': 'Pathology Department, 29 rue du Colisée, Paris, France.'}, {'ForeName': 'Anne-Isabelle', 'Initials': 'AI', 'LastName': 'Lemaistre', 'Affiliation': 'Department of Pathology, Eurofins Biomnis, Lyon, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Cros', 'Affiliation': 'Beaujon Hospital, Pathology Department, Université de Paris, INSERM U1149, Clichy, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Napoléon', 'Affiliation': 'Digestive Endoscopy Unit, Hôpital Privé Jean Mermoz, Ramsay Générale de Santé, Lyon, France.'}]",Endoscopy,['10.1055/a-1160-5485']
1317,31313123,A simple risk score for prediction of sepsis associated-acute kidney injury in critically ill patients.,"BACKGROUND


Sepsis is common and frequently fatal condition in critically ill patients and is a major cause of acute kidney injury (AKI). In this retrospective study, we sought to develop a comprehensive risk score model of sepsis associated-AKI (SA-AKI).
METHODS


A total of 2617 patients were randomly assigned to a development (1554 patients) and a validation group (777 patients). The risk score model for SA-AKI was developed with multivariate regression analysis in development group and the model was further evaluated on validation group.
RESULTS


We identified 16 independent predictors of SA-AKI in development group (age ≥ 60 years, hypertension/coronary heart disease, diabetes, chronic kidney disease, heart failure, chronic obstructive pulmonary disease, acute severe pancreatitis, hypotension, hypoproteinemia, lactic acidosis, the length of stay in intensive care unit(ICU), 60 g/L<hemoglobin < 90 g/L, hemoglobin ≤ 60 g/L, and ≥ 2 failed organs. This model had excellent performance characteristics in validation cohort(c statistic 0.857, 95% CI 0.839-0.874).
CONCLUSION


The novel risk score model for SA-AKI in ICU can identify patients at high risk to develop AKI. Application of this model could help clinicians to stratify patients for primary prevention, surveillance and early therapeutic intervention to improve care and prognosis of sepsis patients in ICU.",2019,"This model had excellent performance characteristics in validation cohort(c statistic 0.857, 95% CI 0.839-0.874).
","['60\xa0years, hypertension/coronary heart disease, diabetes, chronic kidney disease, heart failure, chronic obstructive pulmonary disease, acute severe pancreatitis, hypotension, hypoproteinemia, lactic acidosis, the length of stay in intensive care unit(ICU), 60\xa0g/L<hemoglobin\u2009<\u200990\xa0g/L, hemoglobin', 'sepsis patients in ICU', '2617 patients were randomly assigned to a development (1554 patients) and a validation group (777 patients', 'critically ill patients']",[],[],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0020639', 'cui_str': 'Hypoproteinemia'}, {'cui': 'C1869036', 'cui_str': 'Lactic acidosis (SMQ)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439087', 'cui_str': '<90 (qualifier value)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}]",[],[],2617.0,0.0635966,"This model had excellent performance characteristics in validation cohort(c statistic 0.857, 95% CI 0.839-0.874).
","[{'ForeName': 'Jiaojiao', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Division of Ultrasound, West China Hospital of Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Yajun', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Division of Nephrology, Nanchong Central Hospital, Nanchong, 637000, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Division of Nephrology, West China Hospital of Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Division of Nephrology, West China Hospital of Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Fu', 'Affiliation': 'Division of Nephrology, West China Hospital of Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Dingming', 'Initials': 'D', 'LastName': 'Cai', 'Affiliation': 'Division of Ultrasound, West China Hospital of Sichuan University, Chengdu, 610041, China. doccai@163.com.'}, {'ForeName': 'Lichuan', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Division of Nephrology, West China Hospital of Sichuan University, Chengdu, 610041, China. ylcgh@163.com.'}]",Journal of nephrology,['10.1007/s40620-019-00625-y']
1318,31618704,"Cetuximab, fluorouracil and cisplatin with or without docetaxel for patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (CeFCiD): an open-label phase II randomised trial (AIO/IAG-KHT trial 1108).","BACKGROUND


The combination of cisplatin, 5-fluorouracil (5-FU) and cetuximab (PFC) is the reference first-line treatment for recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN). We analysed whether treatment intensification by the addition of docetaxel to PFC improved efficacy in R/M SCCHN.
METHODS


A total of 180 patients with R/M SCCHN (1:1) were assigned to receive either cisplatin (40 mg/m 2 ), docetaxel (40 mg/m 2 ) and 5-FU (2000 mg/m 2 ) at days 1 and 8 and cetuximab (400/250 mg/m 2 ) at days 1, 8 and 15 (DPFC) or standard cisplatin (100 mg/m 2 ) at day 1, 5-FU (1000 mg/m 2 ) at days 1-4 and cetuximab (400/250 mg/m 2 ) at days 1, 8 and 15 (PFC). Chemotherapy was repeated every 21 days and continued for a maximum of 6 cycles in absence of disease progression or limiting toxicity, followed by cetuximab maintenance (500 mg/m 2  every 2 weeks). The primary end-point was progression-free survival (PFS).
RESULTS


A preplanned interim analysis for toxicity after 20 patients/arm revealed excessive grade 3 and 4 gastrointestinal (65%) and infectious toxicities (35%) in arm A, which led to dose reduction of cisplatin to 30 mg/m 2  and 5-FU to 1000 mg/m 2  for subsequent patients. With a median follow-up of 2 years, grade 4 toxicities were 21.3% vs. 30.8% for DPFC and PFC, respectively. More treatment-related deaths occurred with DPFC vs. PFC, with 11.2% and 6.6%, respectively. For DPFC and PFC, the median PFS was 6.3 vs. 6.4 months (hazard ratio [HR] = 0.97, p = 0.87), the median overall survival was 8.9 vs. 10.6 months (HR = 1.29 p = 0.1) and response rates were 38.2% vs. 31.9% (p = 0.9), respectively.
CONCLUSIONS


DPFC failed to improve efficacy in R/M SCCHN. On the contrary, a high toxicity and mortality rate was detected in both arms, which underscores the vulnerability of patients with R/M SCCHN, and research on the need for further optimisation of the front-line chemotherapy backbone is ongoing.",2019,"More treatment-related deaths occurred with DPFC vs. PFC, with 11.2% and 6.6%, respectively.","['180 patients with R/M SCCHN (1:1', 'recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN', 'patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (CeFCiD']","['docetaxel', '5-FU', 'cetuximab', 'Cetuximab, fluorouracil and cisplatin with or without docetaxel', 'cisplatin, 5-fluorouracil (5-FU) and cetuximab (PFC', 'standard cisplatin', 'cisplatin', 'Chemotherapy']","['median PFS', 'grade 4 toxicities', 'progression-free survival (PFS', 'median overall survival', 'infectious toxicities', 'toxicity and mortality rate', 'response rates', 'deaths', 'toxicity']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",180.0,0.0574359,"More treatment-related deaths occurred with DPFC vs. PFC, with 11.2% and 6.6%, respectively.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Klinghammer', 'Affiliation': 'Department of Hematology & Oncology, Charité University, Berlin, Germany. Electronic address: konrad.klinghammer@charite.de.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Gauler', 'Affiliation': 'Department of Radiation Oncology, West German Cancer Center, University of Duisburg-Essen Medical School, Essen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dietz', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, University Leipzig, Leipzig, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Grünwald', 'Affiliation': 'Interdisciplinary Urooncology, West German Cancer Center, Clinic for Internal Medicine (tumor research) and Clinic for Urology, University of Duisburg-Essen Medical School, Essen, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stöhlmacher', 'Affiliation': 'Department of Tumorgenetics Bonn, Bonn, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Knipping', 'Affiliation': 'Department of Head and Neck Surgery, Klinikum Dessau, Dessau-Roßlau, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schroeder', 'Affiliation': 'Department of Hematology and Oncology, Helios Duisburg, Duisburg, Germany.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Guntinas-Lichius', 'Affiliation': 'Department of Otorhinolaryngology, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Frickhofen', 'Affiliation': 'Department of Hematology & Oncology and Palliative Care, HELIOS Dr Horst Schmidt Kliniken, Wiesbaden, Germany.'}, {'ForeName': 'H-W', 'Initials': 'HW', 'LastName': 'Lindeman', 'Affiliation': 'Department of Hematology & Oncology, KKH Hagen, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Fietkau', 'Affiliation': 'Department of Radiation Oncology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Haxel', 'Affiliation': 'Department of Otolaryngology, AMEOS Klinikum Haldensleben, Haldensleben, Germany; Department of Otolaryngology, Head and Neck Surgery, University Medical Center of the Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Große-Thie', 'Affiliation': 'Department of Medicine, Clinic III - Hematology, Oncology, Palliative Medicine, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Maschmeyer', 'Affiliation': 'Department of Hematology, Oncology and Palliative Care, Klinikum Ernst von Bergmann, Potsdam, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zipfel', 'Affiliation': 'Department of Internal Medicine III, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Martus', 'Affiliation': 'Institute for Clinical Epidemiology and Applied Biometry, University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Knoedler', 'Affiliation': 'University Cancer Center Leipzig, University Leipzig, Leipzig, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Keilholz', 'Affiliation': 'Charité Comprehensive Cancer Center, Berlin, Germany.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.08.018']
1319,30656453,2D versus 3D laparoscopic total mesorectal excision: a developmental multicentre randomised controlled trial.,"AIMS


The role of laparoscopy in rectal cancer has been questioned. 3D laparoscopic systems are suggested to aid optimal surgical performance but have not been evaluated in advanced procedures. We hypothesised that stereoscopic imaging could improve the performance of laparoscopic total mesorectal excision (TME).
METHODS


A multicentre developmental randomised controlled trial comparing 2D and 3D laparoscopic TME was performed (ISRCTN59485808). Trial surgeons were colorectal consultants that had completed their TME proficiency curve and underwent stereoscopic visual testing. Patients requiring elective laparoscopic TME with curative intent were centrally randomised (1:1) to 2D or 3D using Karl Storz IMAGE1 S D3-Link™ and 10-mm TIPCAM®1S 3D passive polarising laparoscopic systems. Outcomes were enacted adverse events as assessed by the observational clinical human reliability analysis technique, intraoperative data, 30-day patient outcomes, histopathological specimen assessment and surgeon cognitive load.
RESULTS


88 patients were included. There were no differences in patient or tumour demographics, surgeon stereopsis, case difficulty, cognitive load, operative time, blood loss or conversion between the trial arms. 1377 intraoperative adverse events were identified (median 18 per case, IQR 14-21, range 2-49) with no differences seen between the 2D and 3D arms (18 (95% CI 17-21) vs. 17 (95% CI 16-19), p = 0.437). 3D laparoscopy had non-significantly higher mesorectal fascial plane resections (94 vs. 77%, p = 0.059; OR 0.23 (95% CI 0.05-1.16)) but equal lymph node yield and circumferential margin distance and involvement. 30-day morbidity, anastomotic leak, re-operation, length of stay and readmission rates were equal between the 2D and 3D arms.
CONCLUSION


Feasibility of performing multicentre 3D laparoscopic multicentre trials of specialist performed complex procedures is shown. 3D imaging did not alter the number of intraoperative adverse events; however, a potential improvement in mesorectal specimen quality was observed and should form the focus of future 3D laparoscopic TME trials.",2019,"30-day morbidity, anastomotic leak, re-operation, length of stay and readmission rates were equal between the 2D and 3D arms.
","['88 patients were included', 'Trial surgeons were colorectal consultants that had completed their TME proficiency curve and underwent stereoscopic visual testing', 'Patients requiring elective laparoscopic TME with curative intent']","['2D versus 3D laparoscopic total mesorectal excision', '2D or 3D using Karl Storz IMAGE1', '3D laparoscopic TME']","['mesorectal specimen quality', 'number of intraoperative adverse events', 'observational clinical human reliability analysis technique, intraoperative data, 30-day patient outcomes, histopathological specimen assessment and surgeon cognitive load', 'performance of laparoscopic total mesorectal excision (TME', '1377 intraoperative adverse events', '30-day morbidity, anastomotic leak, re-operation, length of stay and readmission rates', 'patient or tumour demographics, surgeon stereopsis, case difficulty, cognitive load, operative time, blood loss or conversion', 'mesorectal fascial plane resections']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0042793', 'cui_str': 'Vision Tests'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}]","[{'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic Leakage'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0011586', 'cui_str': 'Stereopsis'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]",88.0,0.528959,"30-day morbidity, anastomotic leak, re-operation, length of stay and readmission rates were equal between the 2D and 3D arms.
","[{'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'Curtis', 'Affiliation': ""Department of Surgery and Cancer, Imperial College London, St Mary's Hospital, Level 10, Praed Street, London, UK. nathancurtis@doctors.org.uk.""}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Conti', 'Affiliation': 'Department of Colorectal Surgery, Portsmouth Hospitals NHS Trust, Southwick Hill Road, Cosham, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dalton', 'Affiliation': 'Department of General Surgery, Yeovil District Hospital NHS Foundation Trust, Higher Kingston, Yeovil, UK.'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Rockall', 'Affiliation': 'Colorectal Surgery, Royal Surrey County Hospital, Egerton Road, Guildford, UK.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Allison', 'Affiliation': 'Department of General Surgery, Yeovil District Hospital NHS Foundation Trust, Higher Kingston, Yeovil, UK.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Ockrim', 'Affiliation': 'Department of General Surgery, Yeovil District Hospital NHS Foundation Trust, Higher Kingston, Yeovil, UK.'}, {'ForeName': 'I C', 'Initials': 'IC', 'LastName': 'Jourdan', 'Affiliation': 'Colorectal Surgery, Royal Surrey County Hospital, Egerton Road, Guildford, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Torkington', 'Affiliation': 'Colorectal Surgery, University Hospital of Wales, Heath Park, Cardiff, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Phillips', 'Affiliation': 'Colorectal Surgery, University Hospital of Wales, Heath Park, Cardiff, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Allison', 'Affiliation': 'Department of General Surgery, Yeovil District Hospital NHS Foundation Trust, Higher Kingston, Yeovil, UK.'}, {'ForeName': 'G B', 'Initials': 'GB', 'LastName': 'Hanna', 'Affiliation': ""Department of Surgery and Cancer, Imperial College London, St Mary's Hospital, Level 10, Praed Street, London, UK.""}, {'ForeName': 'N K', 'Initials': 'NK', 'LastName': 'Francis', 'Affiliation': 'Department of General Surgery, Yeovil District Hospital NHS Foundation Trust, Higher Kingston, Yeovil, UK.'}]",Surgical endoscopy,['10.1007/s00464-018-06630-9']
1320,31404527,Interstitial Lung Abnormalities and Lung Cancer Risk in the National Lung Screening Trial.,"BACKGROUND


Some interstitial lung diseases are associated with lung cancer. However, it is unclear whether asymptomatic interstitial lung abnormalities convey an independent risk.
OBJECTIVES


The goal of this study was to assess whether interstitial lung abnormalities are associated with an increased risk of lung cancer.
METHODS


Data from all participants in the National Lung Cancer Trial were analyzed, except for subjects with preexisting interstitial lung disease or prevalent lung cancers. The primary analysis included those who underwent low-dose CT imaging; those undergoing chest radiography were included in a confirmatory analysis. Participants with evidence of reticular/reticulonodular opacities, honeycombing, fibrosis, or scarring were classified as having interstitial lung abnormalities. Lung cancer incidence and mortality in participants with and without interstitial lung abnormalities were compared by using Poisson and Cox regression, respectively.
RESULTS


Of the 25,041 participants undergoing low-dose CT imaging included in the primary analysis, 20.2% had interstitial lung abnormalities. Participants with interstitial lung abnormalities had a higher incidence of lung cancer (incidence rate ratio, 1.61; 95% CI, 1.30-1.99). Interstitial lung abnormalities were associated with higher lung cancer incidence on adjusted analyses (incidence rate ratio, 1.33; 95% CI, 1.07-1.65). Lung cancer-specific mortality was also greater in participants with interstitial lung abnormalities. Similar findings were obtained in the analysis of participants undergoing chest radiography.
CONCLUSIONS


Asymptomatic interstitial lung abnormalities are an independent risk factor for lung cancer that can be incorporated into risk score models.",2019,"Participants with interstitial lung abnormalities had higher incidence of lung cancer (IRR 1.61, 95% CI: 1.30-1.99).","['all participants in the National Lung Cancer Trial (NSLT) except for subjects with pre-existing interstitial lung disease or prevalent lung cancers', 'Participants with evidence of reticular/reticulonodular opacities, honeycombing, fibrosis, or scarring were classified as having interstitial lung abnormalities', 'participants with and without interstitial lung abnormalities', 'participants with interstitial lung abnormalities', '25,041 participants undergoing']","['LDCT', 'low-dose computed tomography; those undergoing chest radiography']","['lung cancer', 'Lung cancer-specific mortality', 'Interstitial lung abnormalities', 'Lung cancer incidence and mortality', 'Interstitial Lung Abnormalities and Lung Cancer Risk', 'lung cancer incidence', 'interstitial lung abnormalities']","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0332300', 'cui_str': 'Except for (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1869044', 'cui_str': 'Interstitial lung disease (SMQ)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439739', 'cui_str': 'Reticular (qualifier value)'}, {'cui': 'C1265876', 'cui_str': 'Abnormally opaque structure (morphologic abnormality)'}, {'cui': 'C0349384', 'cui_str': 'Honeycomb (substance)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0034571', 'cui_str': 'radiography'}]","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.122423,"Participants with interstitial lung abnormalities had higher incidence of lung cancer (IRR 1.61, 95% CI: 1.30-1.99).","[{'ForeName': 'Stacey-Ann', 'Initials': 'SA', 'LastName': 'Whittaker Brown', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: stacey-ann.brown@mountsinai.org.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Padilla', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Mhango', 'Affiliation': 'Division of General Internal Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Powell', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Salvatore', 'Affiliation': 'Division of Radiology, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Henschke', 'Affiliation': 'Division of Radiology, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Yankelevitz', 'Affiliation': 'Division of Radiology, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Sigel', 'Affiliation': 'Division of General Internal Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'de-Torres', 'Affiliation': 'Division of Respiratory Medicine, Clínica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wisnivesky', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Icahn School of Medicine at Mount Sinai, New York, NY; Division of General Internal Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.'}]",Chest,['10.1016/j.chest.2019.06.041']
1321,30569067,"Native Whey Induces Similar Post Exercise Muscle Anabolic Responses as Regular Whey, Despite Greater Leucinemia, in Elderly Individuals.","OBJECTIVE


Elderly muscle seems less sensitive to the anabolic stimulus of a meal. Changes in blood concentrations of leucine are suggested as one important trigger of the anabolic response in muscle. The aim of this study was to investigate whether native whey protein, containing high amounts of leucine, may be a more potent stimulator of muscle protein synthesis (MPS) in elderly than regular whey protein (WPC-80) or milk.
DESIGN


Randomized controlled partial crossover.
SETTING


Norwegian School of Sport Sciences.
PARTICIPANTS


21 healthy elderly men and women (≥70 years).
INTERVENTION


Participants received either 20 g of WPC-80 and native whey (n = 11) on separate days in a crossover design, or milk (n = 10). Supplements were ingested immediately and two hours after a bout of lower body heavy-load resistance exercise.
MEASUREMENTS


Blood samples and muscle biopsies were collected to measure blood concentrations of amino acids by gas-chromatography mass spectrometry (GCMS), phosphorylation of p70S6K, 4E-BP1 and eEF-2 by immunoblotting and mixed muscle fractional synthetic rate (FSR) by use of [2H5]phenylalanine-infusion, GCMS and isotope-ratio mass spectrometry.
RESULTS


Native whey increased blood leucine concentrations more than WPC-80 (P < 0.05), but not p70S6K phosphorylation or mixed muscle FSR. Both whey supplements increased blood leucine concentrations (P < 0.01) and P70S6K phosphorylation more than milk (P = 0.014). Native whey reached higher mixed muscle FSR values than milk (P = 0.026) 1-3h after exercise.
CONCLUSIONS


Despite greater increases in blood leucine concentrations than WPC-80 and milk, native whey was only superior to milk concerning increases in MPS and phosphorylation of P70S6K during a 5-hour post-exercise period in elderly individuals.",2019,Both whey supplements increased blood leucine concentrations (P < 0.01) and P70S6K phosphorylation more than milk (P = 0.014).,"['Elderly Individuals', '21 healthy elderly men and women (≥70 years', 'Norwegian School of Sport Sciences', 'elderly than regular whey protein (WPC-80) or milk', 'elderly individuals']","['20 g of WPC-80 and native whey', 'WPC-80']","['blood concentrations of amino acids by gas-chromatography mass spectrometry (GCMS), phosphorylation of p70S6K, 4E-BP1 and eEF-2 by immunoblotting and mixed muscle fractional synthetic rate (FSR) by use of [2H5]phenylalanine-infusion, GCMS and isotope-ratio mass spectrometry', 'blood leucine concentrations', 'MPS and phosphorylation of P70S6K', 'mixed muscle FSR values', 'p70S6K phosphorylation or mixed muscle FSR', 'P70S6K phosphorylation']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0524337', 'cui_str': 'Elderly man (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0450403', 'cui_str': '20G (qualifier value)'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0452720', 'cui_str': 'Whey'}]","[{'cui': 'C1313904', 'cui_str': 'Blood concentration, test strip measurement'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0024868', 'cui_str': 'Spectrum Analysis, Mass-Gas Chromatography'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C1136240', 'cui_str': 'Ribosomal Protein S6 Kinases, 70-kDa'}, {'cui': 'C0020985', 'cui_str': 'Immunoblotting'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0022262', 'cui_str': 'Isotopes'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0037813', 'cui_str': 'Spectrum Analysis, Mass'}, {'cui': 'C0005768'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",21.0,0.0224732,Both whey supplements increased blood leucine concentrations (P < 0.01) and P70S6K phosphorylation more than milk (P = 0.014).,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hamarsland', 'Affiliation': 'Håvard Hamarsland, Department of Physical Performance, Norwegian School of Sport Sciences, P.O. Box 4014 Ullevål Stadion, 0806 Oslo, Norway, Tel: +47 93445916. Havard.hamarsland@gmail.com.'}, {'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Aas', 'Affiliation': ''}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Nordengen', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Holte', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Garthe', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Paulsen', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cotter', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Børsheim', 'Affiliation': ''}, {'ForeName': 'H B', 'Initials': 'HB', 'LastName': 'Benestad', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Raastad', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-018-1105-6']
1322,30660371,Effect of Lavender Oil on the Anxiety of Patients Before Breast Surgery.,"PURPOSE


Anxiety is a common problem before surgery. This study aimed to investigate the effects of inhaling lavender oil on anxiety levels in patients before breast surgery.
DESIGN


A randomized controlled design was used.
METHODS


The study was conducted in surgery clinics of a university hospital in Adana, Turkey. The study included a total of 80 patients, 40 patients in the intervention group, and 40 patients in the control group, who were scheduled for breast surgery. Lavender oil was used by inhalation. A Personal Information Form and the State Anxiety Inventory were used to collect data.
FINDINGS


The mean State Anxiety Inventory pretest and post-test scores were 43.00 ± 11.48 and 37.28 ± 9.93, respectively, in the intervention group, indicating a statistically significant difference (P < .05). The mean pretest and post-test State Anxiety Inventory scores were 44.6 ± 11.45 and 42.43 ± 11.48, respectively, in the control group; however, the difference was not statistically significant (P > .05).
CONCLUSIONS


Inhalation of lavender oil before breast surgery decreased anxiety levels of patients. Our study results suggest that the inhalation of lavender oil offered by nurses has positive effects in reducing anxiety levels.",2019,"The mean State Anxiety Inventory pretest and post-test scores were 43.00 ± 11.48 and 37.28 ± 9.93, respectively, in the intervention group, indicating a statistically significant difference (P < .05).","['80 patients, 40 patients in the intervention group, and 40 patients in the control group, who were scheduled for breast surgery', 'patients before breast surgery', 'Patients Before Breast Surgery', 'surgery clinics of a university hospital in Adana, Turkey']","['Lavender Oil', 'lavender oil', 'Lavender oil']","['mean pretest and post-test State Anxiety Inventory scores', 'mean State Anxiety Inventory pretest and post-test scores', 'anxiety levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}]","[{'cui': 'C0064694', 'cui_str': 'lavender oil'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}]",80.0,0.0567346,"The mean State Anxiety Inventory pretest and post-test scores were 43.00 ± 11.48 and 37.28 ± 9.93, respectively, in the intervention group, indicating a statistically significant difference (P < .05).","[{'ForeName': 'Ayşe', 'Initials': 'A', 'LastName': 'Beyliklioğlu', 'Affiliation': ''}, {'ForeName': 'Sevban', 'Initials': 'S', 'LastName': 'Arslan', 'Affiliation': ''}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2018.10.002']
1323,31678062,"Gastric bypass versus sleeve gastrectomy in patients with type 2 diabetes (Oseberg): a single-centre, triple-blind, randomised controlled trial.","BACKGROUND


For patients with obesity and type 2 diabetes, weight loss improves insulin sensitivity and β-cell function, and can induce remission of diabetes. The comparative efficacy of various bariatric procedures for the remission of type 2 diabetes has not been fully elucidated. We aimed to compare the effects of the two most common bariatric procedures, gastric bypass and sleeve gastrectomy, on remission of diabetes and β-cell function.
METHODS


We conducted a single-centre, triple-blind, randomised trial at Vestfold Hospital Trust (Tønsberg, Norway), in which patients (aged ≥18 years) with type 2 diabetes and obesity were randomly assigned (1:1) to receive gastric bypass or sleeve gastrectomy (the Oseberg study). Randomisation was performed with a computerised random number generator and a block size of 10. Treatment allocation was masked from participants, study personnel, and outcome assessors and was concealed with sealed opaque envelopes. Surgeons used identical skin incisions during both surgeries and were not involved in patient follow-up. The primary clinical outcome was the proportion of participants with complete remission of type 2 diabetes (HbA 1c  of ≤6·0% [42 mmol/mol] without the use of glucose-lowering medication) at 1 year after surgery. The primary physiological outcome was disposition index (a measure of β-cell function) at 1 year after surgery, as assessed by an intravenous glucose tolerance test. Primary outcomes were analysed in the intention-to-treat and per-protocol populations. This trial is ongoing and closed to recruitment, and is registered with ClinicalTrials.gov, NCT01778738.
FINDINGS


Between Oct 15, 2012, and Sept 1, 2017, 1305 patients who were preparing for bariatric surgery were screened, of whom 319 consecutive patients with type 2 diabetes were assessed for eligibility. 109 patients were enrolled and randomly assigned to gastric bypass (n=54) or sleeve gastrectomy (n=55). 107 (98%) of 109 patients completed 1-year follow-up, with one patient in each group withdrawing after surgery (per-protocol population). In the intention-to-treat population, diabetes remission rates were higher in the gastric bypass group than in the sleeve gastrectomy group (risk difference 27% [95% CI 10 to 44]; relative risk [RR] 1·57 [1·14 to 2·16], p=0·0054); results were similar in the per-protocol population (risk difference 27% [95% CI 10 to 45]; RR 1·57 [1·14 to 2·15], p=0·0036). In the intention-to-treat population, disposition index increased in both groups (between-group difference 55 [-111 to 220], p=0·52); results were similar in the per-protocol population (between-group difference 21 [-214 to 256], p=0.86). In the gastric bypass group, ten of 54 participants had early complications and 17 of 53 had late side-effects. In the sleeve gastrectomy group, eight of 55 participants had early complications and 22 of 54 had late side-effects. No deaths occurred in either group.
INTERPRETATION


Gastric bypass was found to be superior to sleeve gastrectomy for remission of type 2 diabetes at 1 year after surgery, and the two procedures had a similar beneficial effect on β-cell function. The use of gastric bypass as the preferred bariatric procedure for patients with obesity and type 2 diabetes could improve diabetes care and reduce related societal costs.
FUNDING


Morbid Obesity Centre, Vestfold Hospital Trust.",2019,"INTERPRETATION


Gastric bypass was found to be superior to sleeve gastrectomy for remission of type 2 diabetes at 1 year after surgery, and the two procedures had a similar beneficial effect on β-cell function.","['patients (aged ≥18 years) with type 2 diabetes and obesity', 'patients with obesity and type 2 diabetes', 'Between Oct 15, 2012, and Sept 1, 2017, 1305 patients who were preparing for bariatric surgery were screened, of whom 319 consecutive patients with type 2 diabetes', 'patients with type 2 diabetes (Oseberg', '109 patients']","['sleeve gastrectomy', 'gastric bypass and sleeve gastrectomy', 'gastric bypass', 'gastric bypass or sleeve gastrectomy', 'various bariatric procedures', 'Gastric bypass versus sleeve gastrectomy']","['diabetes remission rates', 'disposition index', 'intravenous glucose tolerance test', 'disposition index (a measure of β-cell function', 'proportion of participants with complete remission of type 2 diabetes', 'early complications', 'deaths', 'intention-to-treat and per-protocol populations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0743223', 'cui_str': 'Disposition (disposition)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021911', 'cui_str': 'Intravenous Glucose Tolerance Test'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0231243', 'cui_str': 'Early complication (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",1305.0,0.153451,"INTERPRETATION


Gastric bypass was found to be superior to sleeve gastrectomy for remission of type 2 diabetes at 1 year after surgery, and the two procedures had a similar beneficial effect on β-cell function.","[{'ForeName': 'Dag', 'Initials': 'D', 'LastName': 'Hofsø', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Farhat', 'Initials': 'F', 'LastName': 'Fatima', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Borgeraas', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Kåre Inge', 'Initials': 'KI', 'LastName': 'Birkeland', 'Affiliation': 'Department of Transplantation, Institute of Clinical Medicine, University of Oslo and Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Hanne Løvdal', 'Initials': 'HL', 'LastName': 'Gulseth', 'Affiliation': 'Department of Chronic Diseases and Ageing, Norwegian Institute of Public Health, Oslo, Norway; Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jens Kristoffer', 'Initials': 'JK', 'LastName': 'Hertel', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Line Kristin', 'Initials': 'LK', 'LastName': 'Johnson', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Lindberg', 'Affiliation': 'Department of Laboratory Medicine, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Njord', 'Initials': 'N', 'LastName': 'Nordstrand', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Milada', 'Initials': 'M', 'LastName': 'Cvancarova Småstuen', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway; Department of Nutrition and Management, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Darko', 'Initials': 'D', 'LastName': 'Stefanovski', 'Affiliation': 'New Bolton Center, School of Veterinary Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Svanevik', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway; Department of Surgery, Vestfold Hospital Trust, Tønsberg, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Gretland Valderhaug', 'Affiliation': 'Department of Endocrinology, Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Sandbu', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway; Department of Surgery, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Jøran', 'Initials': 'J', 'LastName': 'Hjelmesæth', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway; Department of Endocrinology, Morbid Obesity and Preventive Medicine, Institute of Clinical Medicine, University of Oslo, Norway. Electronic address: joran.hjelmeseth@siv.no.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30344-4']
1324,30648520,The Effect of Methylphenidate on Reed Scaling in Benzodiazepine Poisoning: A Prospective Trial.,"BACKGROUND


Benzodiazepine is one of the most important causes of substance abuse and intoxication throughout the world and Iran.
OBJECTIVE


The aim of our study is to determine the role of stimulants in reversing CNS level in acute Benzodiazepine poisoning patients who were hospitalized at referral poison center.
METHOD


This was a randomized double-blind placebo-controlled trial study on 32 cases with pure acute Benzodiazepine poisoning from March 2016 to February 2017. Diagnosis of pure acute poisoning was based on history, and laboratory confirmation. We gathered the demographics, clinical data, laboratory data, hospitalization and outcome. Participants were randomized into two groups: Methylphenidate Group (MPH) and Placebo Group (PBO).
RESULTS


The randomized sample consisted of 32 participants who were predominately female (83%). The majority of the PBO group and the MPH group reported improvement in their consciousness with a significant difference between the two groups (p = .005). Paired sample t-test analyses on Reed Scale data revealed an increase in the probability of improvement during the trial for the MPH group compared to the PBO group. Furthermore, the HCo3 (bicarbonate) level has a significant p-value with respect to age groups (p = .02). None of our cases required either the ICU facility or intubation.
CONCLUSION


Our study provided the MPH superiority over PBO in reversing CNS symptoms in loss of consciousness in acute BZD poisoned patients. Thus, this trial provides concrete evidence that improvement in consciousness levels (Reed Scale rated) among those patients receiving MPH was associated with a methylphenidate use.",2020,The majority of the PBO group and the MPH group reported improvement in their consciousness with a significant difference between the two groups (p = .005).,"['32 cases with pure acute Benzodiazepine poisoning from March 2016 to February 2017', '32 participants who were predominately female (83', 'acute Benzodiazepine poisoning patients who were hospitalized a referral poison center', 'acute BZD poisoned patients']","['Benzodiazepine', 'Methylphenidate Group (MPH) and Placebo Group (PBO', 'methylphenidate', 'placebo']","['HCo3 (bicarbonate) level', 'consciousness levels']","[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0412862', 'cui_str': 'Benzodiazepine poisoning'}, {'cui': 'C0332251', 'cui_str': 'Predominate (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0032344', 'cui_str': 'poisoning'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}]",32.0,0.146873,The majority of the PBO group and the MPH group reported improvement in their consciousness with a significant difference between the two groups (p = .005).,"[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Latifi-Pour', 'Affiliation': 'Toxicological Research Center and Excellence Center of Clinical Toxicology, Department of Clinical Toxicology, Loghman Hakim Hospital Poison Center, Shahid Beheshti University of Medical Sciences, Kamali Avenue, South Karegar Street, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Hassanian-Moghaddam', 'Affiliation': 'Toxicological Research Center and Excellence Center of Clinical Toxicology, Department of Clinical Toxicology, Loghman Hakim Hospital Poison Center, Shahid Beheshti University of Medical Sciences, Kamali Avenue, South Karegar Street, Tehran, Iran.'}, {'ForeName': 'Helya-Sadat', 'Initials': 'HS', 'LastName': 'Mortazavi', 'Affiliation': 'Toxicological Research Center and Excellence Center of Clinical Toxicology, Department of Clinical Toxicology, Loghman Hakim Hospital Poison Center, Shahid Beheshti University of Medical Sciences, Kamali Avenue, South Karegar Street, Tehran, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Shadnia', 'Affiliation': 'Toxicological Research Center and Excellence Center of Clinical Toxicology, Department of Clinical Toxicology, Loghman Hakim Hospital Poison Center, Shahid Beheshti University of Medical Sciences, Kamali Avenue, South Karegar Street, Tehran, Iran.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Zamani', 'Affiliation': 'Toxicological Research Center and Excellence Center of Clinical Toxicology, Department of Clinical Toxicology, Loghman Hakim Hospital Poison Center, Shahid Beheshti University of Medical Sciences, Kamali Avenue, South Karegar Street, Tehran, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Rahimi', 'Affiliation': 'Toxicological Research Center and Excellence Center of Clinical Toxicology, Department of Clinical Toxicology, Loghman Hakim Hospital Poison Center, Shahid Beheshti University of Medical Sciences, Kamali Avenue, South Karegar Street, Tehran, Iran.'}]",Current clinical pharmacology,['10.2174/1574884714666190112153157']
1325,30635252,"Comparison of two schedules of two-dose priming with the ten-valent pneumococcal conjugate vaccine in Nepalese children: an open-label, randomised non-inferiority controlled trial.","BACKGROUND


Nepalese infants receive ten-valent pneumococcal conjugate vaccine (PCV10) with a 1 month interval between priming doses for programmatic reasons. We aimed to investigate whether immune responses to PCV10 serotypes were non-inferior if the second priming dose of PCV10 was delivered at a 1 month interval as opposed to a 2 month interval.
METHODS


We did an open-label, randomised, parallel group trial in healthy Nepalese infants aged 40-60 days at Patan Hospital, Kathmandu, Nepal. Children were eligible for inclusion if they were healthy, were born at more than or equal to 37 weeks' gestation, were residing in Kathmandu, and had not had any previous vaccinations other than BCG, and oral polio vaccine. Participants were randomly assigned (1:1) by means of a computer-generated list with randomly varying permuted block sizes accessed through a validated web-based interface, to receive PCV10 either at 6 weeks and 10 weeks of age (6 + 10 group) or at 6 weeks and 14 weeks of age (6 + 14 group), with both groups receiving a booster at 9 months of age. Laboratory staff, masked to study intervention, analysed serum samples for antibodies against PCV10 serotypes by ELISA. The primary outcome was to determine whether the 6 + 10 schedule was non-inferior to the 6 + 14 schedule at 9 months of age, on the basis of the proportion of infants with serotype-specific IgG greater than or equal to 0·35 μg/mL. Non-inferiority was established with a 10% margin, and the primary endpoint was measured in a modified intention-to-treat population, which included only participants who successfully had a blood sample collected. This trial is registered at ClinicalTrials.gov, number NCT02385513.
FINDINGS


Between Aug 21, 2015, and April 4, 2016, 304 Nepalese children were randomly assigned to either the 6 + 10 group (n=152) or the 6 + 14 group (n=152). At 9 months of age, the 6 + 10 schedule was non-inferior for serotype 5 (79 [55·2%] of 143 vs 78 [53·4%] of 146, difference 1·82% [95% CI -9·6 to 13·25], p=0·021), serotype 9V (66 [46·1%] of 143 vs 55 [37·6%] of 146, difference 8·48% [-2·84 to 19·8], p=0·001), serotype 14 (110 [77·4%] of 142 vs 110 [74·8%] of 147, difference 2·63% [-7·27 to 12·54], p=0·006), and serotype 19F (135 [95%] of 142 vs 146 [100%] of 146, difference -4·92% [-9·86 to 0], p=0·022). At the same timepoint, non-inferiority was not shown for serotype 1 (36 [25·1%] of 143 vs 42 [28·5%] of 147, difference -3·39% [95% CI -13·56 to 6·77], p=0·102), serotype 4 (70 [48·9%] of 143 vs 87 [59·1%] of 147, difference -10·23% [-21·64 to 1·18], p=0·516), serotype 6B (96 [67·1%] of 143 vs 114 [77·5%] of 147, difference -10·41% [-20·65 to -0·18], p=0·532), serotype 7F (99 [69·2%] of 143 vs 109 [74·1%] of 147, difference -4·91% [-15·26 to 5·42], p=0·168), serotype 18C (89 [62·2%] of 143 vs 114 [77·5%] of 147, difference -15·31% [-25·78 to -4·83], p=0·840), and serotype 23F (37 [25·8%] of 143 vs 41 [27·8%] of 147, difference -2·01% [-12·19 to 8·16], p=0·062). After the booster dose, at 10 months of age, there were no significant differences in immunogenicity (proportion of children with antibody greater than or equal to 0.35 μg/mL) for any of the ten serotypes, when comparing the two schedules. Serious adverse events occurred in 32 participants, 11 (7%) of 152 in the 6 + 10 group and 21 (14%) of 152 in the 6  +  14 group.
INTERPRETATION


The 6 week, 14 week, and 9 month schedule should be implemented where possible. However, post-booster responses, which are thought to drive herd immunity, were similar in the two schedules. Therefore, the 6 week, 10 week, and 9 month schedule is an alternative that can be used when logistically necessary, and is expected to provide herd protection.
FUNDING


Gavi, the Vaccine Alliance.",2019,"At the same timepoint, non-inferiority was not shown for serotype 1 (36 [25·1%] of 143 vs 42 [28·5%] of 147, difference -3·39% [95% CI -13·56 to 6·77], p=0·102), serotype 4 (70 [48·9%] of 143 vs 87 [59·1%] of 147, difference -10·23% [-21·64 to 1·18], p=0·516), serotype 6B (96 [67·1%] of 143 vs 114 [77·5%] of 147, difference -10·41% [-20·65 to -0·18], p=0·532), serotype 7F (99 [69·2%] of 143 vs 109 [74·1%] of 147, difference -4·91% [-15·26 to 5·42], p=0·168), serotype 18C (89 [62·2%] of 143 vs 114 [77·5%] of 147, difference -15·31% [-25·78 to -4·83], p=0·840), and serotype 23F (37 [25·8%] of 143 vs 41 [27·8%] of 147, difference -2·01% [-12·19 to 8·16], p=0·062).","['304 Nepalese children', 'Nepalese children', 'Nepalese infants receive ten', ""Children were eligible for inclusion if they were healthy, were born at more than or equal to 37 weeks' gestation, were residing in Kathmandu, and had not had any previous vaccinations other than BCG, and oral polio vaccine"", 'healthy Nepalese infants aged 40-60 days at Patan Hospital, Kathmandu, Nepal', 'Between Aug 21, 2015, and April 4, 2016']","['valent pneumococcal conjugate vaccine (PCV10', 'valent pneumococcal conjugate vaccine', 'PCV10', 'computer-generated list with randomly varying permuted block sizes accessed through a validated web-based interface, to receive PCV10']","['immunogenicity', 'Serious adverse events']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205394', 'cui_str': 'Other (qualifier value)'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0027689', 'cui_str': 'Federal Democratic Republic of Nepal'}]","[{'cui': 'C1579319', 'cui_str': 'Streptococcus pneumoniae conjugate vaccine'}, {'cui': 'C3849486', 'cui_str': 'ten-valent PCV'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}]",304.0,0.327707,"At the same timepoint, non-inferiority was not shown for serotype 1 (36 [25·1%] of 143 vs 42 [28·5%] of 147, difference -3·39% [95% CI -13·56 to 6·77], p=0·102), serotype 4 (70 [48·9%] of 143 vs 87 [59·1%] of 147, difference -10·23% [-21·64 to 1·18], p=0·516), serotype 6B (96 [67·1%] of 143 vs 114 [77·5%] of 147, difference -10·41% [-20·65 to -0·18], p=0·532), serotype 7F (99 [69·2%] of 143 vs 109 [74·1%] of 147, difference -4·91% [-15·26 to 5·42], p=0·168), serotype 18C (89 [62·2%] of 143 vs 114 [77·5%] of 147, difference -15·31% [-25·78 to -4·83], p=0·840), and serotype 23F (37 [25·8%] of 143 vs 41 [27·8%] of 147, difference -2·01% [-12·19 to 8·16], p=0·062).","[{'ForeName': 'Rama', 'Initials': 'R', 'LastName': 'Kandasamy', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK. Electronic address: rama.kandasamy@paediatrics.ox.ac.ukw.'}, {'ForeName': 'Meeru', 'Initials': 'M', 'LastName': 'Gurung', 'Affiliation': 'Paediatric Research Unit, Patan Academy of Health Sciences, Kathmandu, Nepal.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Thorson', 'Affiliation': 'Paediatric Research Unit, Patan Academy of Health Sciences, Kathmandu, Nepal.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ushma', 'Initials': 'U', 'LastName': 'Galal', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Merryn', 'Initials': 'M', 'LastName': 'Voysey', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kelly', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Wahl', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Berbers', 'Affiliation': 'National Institute for Public Health and the Environment, Bilthoven, Utrecht, Netherlands.'}, {'ForeName': 'Kier', 'Initials': 'K', 'LastName': 'Finnegan', 'Affiliation': 'Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Ansari', 'Affiliation': 'Paediatric Research Unit, Patan Academy of Health Sciences, Kathmandu, Nepal.'}, {'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Paudel', 'Affiliation': 'Child Health Division, Ministry of Health, Kathmandu, Nepal.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Murdoch', 'Affiliation': 'Department of Pathology, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': ""O'Brien"", 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Dominic F', 'Initials': 'DF', 'LastName': 'Kelly', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Goldblatt', 'Affiliation': 'Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Shrijana', 'Initials': 'S', 'LastName': 'Shrestha', 'Affiliation': 'Paediatric Research Unit, Patan Academy of Health Sciences, Kathmandu, Nepal.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30568-1']
1326,30660594,Financial incentives for achieving and maintaining viral suppression among HIV-positive adults in Uganda: a randomised controlled trial.,"BACKGROUND


Viral suppression among HIV-positive individuals is essential for protecting health and preventing HIV transmission. Financial incentives have shown promise in modifying various health behaviours in low-income countries but few studies have assessed whether they can improve HIV treatment outcomes. We aimed to determine the impact of time-limited financial incentives on viral suppression among HIV-positive adults in rural Uganda.
METHODS


We did a randomised controlled trial in four rural Ugandan parishes. We recruited HIV-positive individuals (aged ≥18 years) from community health campaigns that included HIV testing services or at a local government health facility where HIV treatment is offered. Participants included those who were initiating antiretroviral therapy (ART) or already receiving ART. Eligibility to participate in the study did not depend on current ART or viral suppression status. Participants were randomly allocated (1:1) to the financial incentive intervention or the control group in computer-generated blocks (block size 10 participants) and pre-printed scratch cards were used to reveal study group assignment. We measured participants' viral load at baseline and at weeks 6, 12, 24, and 48. At each timepoint, we provided results and viral load counselling. Participants in the intervention group received financial incentives for viral suppression at weeks 6, 12, and 24, with incentive amounts increasing from US$4 to $12·5. The primary outcome was viral suppression (viral load <400 copies per mL) at 24 weeks in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02890459.
FINDINGS


Between June 27, 2016, and May 25, 2018, we enrolled 400 adults in the study, of whom 203 were randomly assigned to the intervention group and 197 to the control group. Of these, 324 were enrolled from community health campaigns and 76 from the government clinic. Eight (2%) withdrew from the study and were not included in analyses. Over the 48-week follow-up period, 35 (9%) died or were lost-to-follow-up. Participants' median daily income was $0·79. At baseline, 300 participants (77%) were virally suppressed. In intention-to-treat analyses, 168 participants (84%) in the intervention group and 156 (82%) in the control group were virally suppressed at 24 weeks (odds ratio 1·14, 95% CI 0·68-1·93, p=0·62). Six participants (3%) in the control group and four (2%) in the intervention group had adverse events. Six of the adverse events were serious, including two deaths in the intervention group, three deaths in the control group, and one serious injury (tibia fracture) after an auto accident. No adverse events or deaths were related to study participation.
INTERPRETATION


Financial incentives had no effect on viral suppression among HIV-positive adults. High baseline viral suppression and provision of viral load results might have contributed to high viral suppression among participants. These findings highlight the need for interventions that promote achievement of viral suppression among unsuppressed individuals.
FUNDING


National Institute of Mental Health at the US National Institutes of Health.",2019,"Six of the adverse events were serious, including two deaths in the intervention group, three deaths in the control group, and one serious injury (tibia fracture) after an auto accident.","['HIV-positive adults in Uganda', 'HIV-positive individuals', 'HIV-positive adults in rural Uganda', '324 were enrolled from community health campaigns and 76 from the government clinic', 'four rural Ugandan parishes', 'HIV-positive individuals (aged ≥18 years) from community health campaigns that included HIV testing services or at a local government health facility where HIV treatment is offered', 'Between June 27, 2016, and May 25, 2018, we enrolled 400 adults in the study, of whom 203 were randomly assigned to the intervention group and 197 to the control group', 'Participants included those who were initiating antiretroviral therapy (ART) or already receiving ART']","['financial incentives for viral suppression', 'financial incentive intervention or the control group in computer-generated blocks (block size 10 participants) and pre-printed scratch cards']","['viral suppression', 'viral suppression (viral load', 'adverse events or deaths', 'adverse events', 'median daily income']","[{'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0241520', 'cui_str': 'Ugandans (ethnic group)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0026788', 'cui_str': 'Local Government'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C4704708', 'cui_str': 'Pre-Print'}, {'cui': 'C1384489', 'cui_str': 'Scratch marks (finding)'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}]",400.0,0.343513,"Six of the adverse events were serious, including two deaths in the intervention group, three deaths in the control group, and one serious injury (tibia fracture) after an auto accident.","[{'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Thirumurthy', 'Affiliation': 'Department of Medical Ethics and Health Policy, Perelman School of Medicine and Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: hthirumu@upenn.edu.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Ndyabakira', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Marson', 'Affiliation': 'Division of HIV, Infectious Diseases and Global Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Devy', 'Initials': 'D', 'LastName': 'Emperador', 'Affiliation': 'Division of HIV, Infectious Diseases and Global Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Kamya', 'Affiliation': 'Makerere University, Kampala, Uganda.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Havlir', 'Affiliation': 'Division of HIV, Infectious Diseases and Global Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Dalsone', 'Initials': 'D', 'LastName': 'Kwarisiima', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Chamie', 'Affiliation': 'Division of HIV, Infectious Diseases and Global Medicine, University of California, San Francisco, CA, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(18)30330-8']
1327,30576085,Improvement of bone mineral density and markers of proximal renal tubular function in chronic hepatitis B patients switched from tenofovir disoproxil fumarate to tenofovir alafenamide.,"Tenofovir alafenamide (TAF) is a novel prodrug that reduces tenofovir plasma levels by 90% compared to tenofovir disoproxil fumarate (TDF), resulting in decreased bone mineral density (BMD) loss and renal toxicity. We aimed to study changes in BMD and markers of renal function of chronic hepatitis B (CHB) patients previously treated with TDF who were switched to TAF in as early as 12 weeks. This was a prospective single-arm open-label study of 75 CHB patients treated with TDF 300 mg daily who were switched to TAF 25 mg daily and followed for 24 weeks. All patients had been treated with TDF for at least 12 months and had HBV DNA <21 IU/mL at the time of switch. BMD and markers of renal function were taken on the day of switch and repeated after 12 and 24 weeks of TAF treatment. Hip and spine bone mineral density significantly increased from baseline to week 12 (+12.9% and +2.4%, respectively, P < 0.01). There were significant decreases in urinary beta-2-microglobulin to creatinine and retinol-binding protein to creatinine ratios by week 12 (P < 0.01 for both). Mean estimated glomerular filtration rate (GFR) did not change. Tubular reabsorption of phosphate was decreased at week 24 (P < 0.05). In conclusion, CHB patients previously treated with TDF experienced significant improvement in bone density and some markers of renal tubular function and as early as 12 weeks after switching to TAF. Bone density changes associated with TDF may not be entirely related to renal handling of phosphate.",2019,There were significant decreases in urinary beta-2-microglobulin to creatinine and retinol-binding protein to creatinine ratios by week 12 (P ,"['chronic hepatitis B patients switched from', '75 CHB patients treated with']","['tenofovir disoproxil fumarate (TDF', 'TDF', 'TAF', 'tenofovir disoproxil fumarate to tenofovir alafenamide', 'TDF 300\xa0mg daily who were switched to TAF', 'Tenofovir alafenamide (TAF']","['Hip and spine bone mineral density', 'BMD and markers of renal function', 'bone density and some markers of renal tubular function', 'bone mineral density and markers of proximal renal tubular function', 'Tubular reabsorption of phosphate', 'bone mineral density (BMD) loss and renal toxicity', 'Mean estimated glomerular filtration rate (GFR', 'urinary beta-2-microglobulin to creatinine and retinol-binding protein to creatinine ratios', 'tenofovir plasma levels']","[{'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0332208', 'cui_str': 'Tubular (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0232816', 'cui_str': 'Tubular reabsorption, function (observable entity)'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3811844'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0201910', 'cui_str': 'Beta-2-microglobulin measurement (procedure)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C1446172', 'cui_str': 'Retinol binding protein measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",75.0,0.0191624,There were significant decreases in urinary beta-2-microglobulin to creatinine and retinol-binding protein to creatinine ratios by week 12 (P ,"[{'ForeName': 'Tse-Ling', 'Initials': 'TL', 'LastName': 'Fong', 'Affiliation': 'Asian Pacific Liver Center at Saint Vincent Medical Center, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Lee', 'Affiliation': 'Division of Gastrointestinal and Liver Diseases, Keck School of Medicine, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Tien', 'Affiliation': 'Asian Pacific Liver Center at Saint Vincent Medical Center, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Chang', 'Affiliation': 'Asian Pacific Liver Center at Saint Vincent Medical Center, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Lim', 'Affiliation': 'Asian Pacific Liver Center at Saint Vincent Medical Center, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Aiden', 'Initials': 'A', 'LastName': 'Ahn', 'Affiliation': 'Asian Pacific Liver Center at Saint Vincent Medical Center, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Ho S', 'Initials': 'HS', 'LastName': 'Bae', 'Affiliation': 'Asian Pacific Liver Center at Saint Vincent Medical Center, University of Southern California, Los Angeles, California.'}]",Journal of viral hepatitis,['10.1111/jvh.13053']
1328,32408390,Does tamsulosin or mirabegron improve ureteral stent-related symptoms? A prospective placebo-controlled study.,"OBJECTIVE


The main objective of this study was to evaluate the efficacy of tamsulosin or mirabegron on ureteral stent-related symptoms.
PATIENTS AND METHODS


This was a prospective, randomized, controlled, and single-blinded study. In total, 180 patients who had undergone ureterolithotripsy and ureteral stent insertion were included. Patients were randomly divided into three groups as follows: Group 1 was the control group taking placebo; group 2 was administered tamsulosin (0.4 mg) once a day; and group 3 received mirabegron (50 mg) once a day. The Turkish version of the ureteral stent symptom questionnaire was filled out after 4 weeks.
RESULTS


After excluding patients who were lost to follow-up, 161 patients were included in the final analysis. Analgesic usage doses were lower in the tamsulosin (5.1 ± 1.8) and mirabegron (4.5 ± 1.4) groups than in the control group (5.9 ± 2.1; P < .001). The urinary symptoms score was lower in tamsulosin group than it was in the control group (22.1 vs 27.8; P = .001); however, the other scores (body pain, general health, work performance, sexual matters, and other problems) were similar between the groups.
CONCLUSIONS


Tamsulosin improves only urinary symptoms due to the ureteral stent and decreases the need for analgesics. Mirabegron has no effect on ureteral stent-related symptoms, but it decreases analgesic need.",2020,Analgesic usage doses were lower in the tamsulosin (5.1 ± 1.8) and mirabegron (4.5 ± 1.4) groups than in the control group (5.9 ± 2.1; P < .001).,"['After excluding patients who were lost to follow-up, 161 patients were included in the final analysis', '180 patients who had undergone ureterolithotripsy and ureteral stent insertion were included']","['tamsulosin', 'Tamsulosin', 'mirabegron', 'placebo']","['urinary symptoms score', 'Analgesic usage doses', 'scores (body pain, general health, work performance, sexual matters, and other problems', 'Turkish version of the ureteral stent symptom questionnaire']","[{'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0864052', 'cui_str': 'Ureteral stent insertion'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0041402', 'cui_str': 'Turkish language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0183518', 'cui_str': 'Ureteric stent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",180.0,0.0625317,Analgesic usage doses were lower in the tamsulosin (5.1 ± 1.8) and mirabegron (4.5 ± 1.4) groups than in the control group (5.9 ± 2.1; P < .001).,"[{'ForeName': 'Abdulmecit', 'Initials': 'A', 'LastName': 'Yavuz', 'Affiliation': 'Urology Department, Gelisim Private Hospital, Hatay, Turkey.'}, {'ForeName': 'Muhammet F', 'Initials': 'MF', 'LastName': 'Kilinc', 'Affiliation': 'Urology Department, Ankara Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Aydin', 'Affiliation': 'Urology Department, Samsun Training and Research Hospital, Samsun, Turkey.'}, {'ForeName': 'Yilmaz', 'Initials': 'Y', 'LastName': 'Ofluoglu', 'Affiliation': 'Urology Department, Medical Park Private Hospital, Trabzon, Turkey.'}, {'ForeName': 'Göksel', 'Initials': 'G', 'LastName': 'Bayar', 'Affiliation': 'Urology Department, Sancaktepe Martyr Prof Dr Ilhan Varank Training and Research Hospital, Istanbul, Turkey.'}]",Lower urinary tract symptoms,['10.1111/luts.12320']
1329,30644784,"Identifying the barriers and perceptions of non-Hispanic black and Hispanic/Latino persons with uncontrolled type 2 diabetes for participation in a home Telemonitoring feasibility study: a quantitative analysis of those who declined participation, withdrew or were non-adherent.","Objectives:  Type 2 Diabetes Mellitus and its complications disproportionately affect non-Hispanic blacks and Hispanic/Latinos more than non-Hispanic whites. These disparities stem from complex interactions between biological, behavioral and socioeconomic factors. In recent years, telemedicine has been used to manage Type 2 Diabetes; however limited recruitment and retention of black and Hispanic/Latino patients into clinical trials exploring the use of telemedicine have necessitated the elucidation of their perceptions regarding participation in such trials. This study investigated patient-reported reasons for declining participation, prematurely terminating participation or demonstrating poor adherence to the study protocol in an ongoing randomized clinical trial, 'Feasibility of Telehealth Management of Diabetes Mellitus type 2 (T2DM) in Black and Hispanic Minority Patients'. Design:  Semi-structured interviews comprised of open-ended questions and prompts were conducted by telephone to gauge patients' actual and perceived challenges to participating in the trial and using telemedicine to manage their diabetes. Data were collated with that of the original clinical trial and subsequently content analyzed for overarching themes and trends. Results:  Eight semi-structured interviews were completed telephonically. Themes that emerged from analysis included disinterest (47%), inconvenience (33%), lack of perceived benefit (13%), lack of awareness of diabetes diagnosis (7%) and perceived lack of ability to fully participate in the study (7%). Conclusion:  Adoption of telemedicine to help minority patients manage diabetes holds promise but is limited by patient factors such as disinterest, inconvenience and lack of perceived benefit. Greater awareness and understanding of these issues will be critical as we strive for greater health equity in disparity patients with uncontrolled diabetes.",2020,"CONCLUSION


Adoption of telemedicine to help minority patients manage diabetes holds promise but is limited by patient factors such as disinterest, inconvenience and lack of perceived benefit.","['disparity patients with uncontrolled diabetes', 'Type 2 Diabetes Mellitus and its complications disproportionately affect non-Hispanic blacks and Hispanic/Latinos more than non-Hispanic whites', 'Diabetes Mellitus type 2 (T2DM) in Black and Hispanic Minority Patients']",['telemedicine'],['lack of awareness of diabetes diagnosis'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205172', 'cui_str': 'More (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0589402', 'cui_str': 'Lack of awareness'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",,0.0285775,"CONCLUSION


Adoption of telemedicine to help minority patients manage diabetes holds promise but is limited by patient factors such as disinterest, inconvenience and lack of perceived benefit.","[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Tong', 'Affiliation': 'Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.'}, {'ForeName': 'Alyson K', 'Initials': 'AK', 'LastName': 'Myers', 'Affiliation': 'Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.'}, {'ForeName': 'Aditya A', 'Initials': 'AA', 'LastName': 'Bissoonauth', 'Affiliation': 'Department of Medicine, Division of Endocrinology, North Shore University Hospital, Northwell Health, Manhasset, NY, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Pekmezaris', 'Affiliation': 'Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Kozikowski', 'Affiliation': 'National Commission on Certification of Physician Assistants, Johns Creek, GA, USA.'}]",Ethnicity & health,['10.1080/13557858.2019.1566520']
1330,30660617,"Treatment of acute hepatitis C genotypes 1 and 4 with 8 weeks of grazoprevir plus elbasvir (DAHHS2): an open-label, multicentre, single-arm, phase 3b trial.","BACKGROUND


Direct-acting antivirals effectively treat chronic hepatitis C virus (HCV) infection but there is a paucity of data on their efficacy for acute HCV, when immediate treatment could prevent onward transmission. We assessed the efficacy of grazoprevir plus elbasvir treatment in acute HCV infection and investigated whether treatment can be shortened during the acute phase of HCV infection.
METHODS


The Dutch Acute HCV in HIV study number 2 (DAHHS2) study was a single-arm, open-label, multicentre, phase 3b trial. Adult patients (≥18 years) with acute HCV genotype 1 or 4 infection (duration of infection 26 weeks or less, according to presumed day of infection) were recruited at 15 HIV outpatient clinics in the Netherlands and Belgium. All patients were treated with 8 weeks of grazoprevir 100 mg plus elbasvir 50 mg administered as one oral fixed drug combination tablet once daily. The primary efficacy endpoint was sustained virological response at 12 weeks after the end of treatment (SVR12; HCV RNA <15 IU/mL) in all patients who started treatment. Reinfection with a different HCV virus was not considered treatment failure in the primary analysis. This trial is registered with ClinicalTrials.gov, number NCT02600325.
FINDINGS


Between Feb 15, 2016, and March 2, 2018, we assessed 146 patients with a recently acquired HCV infection for eligibility, of whom 86 were enrolled and 80 initiated therapy, all within 6 months after infection. All patients who initiated treatment completed treatment and no patients were lost to follow-up. 79 (99%, 95% CI 93-100) of 80 patients achieved SVR12. All 14 patients who were infected with a virus carrying a clinically significant polymorphism in NS5A were cured. If reinfections were considered treatment failures, 75 (94%, 86-98) of 80 patients achieved SVR12. Two serious adverse events not considered related to the treatment were reported (traumatic rectal bleeding and low back surgery). The most common adverse event was a new sexually transmitted infection (19 [24%] of 80 patients). The most common reported possibly drug-related adverse events were fatigue (11 [14%] patients), headache (seven [9%] patients), insomnia (seven [9%] patients), mood changes (five [6%] patients), dyspepsia (five [6%] patients), concentration impairment (four [5%] patients), and dizziness (4 [5%] patients), all of which were regarded as mild by the treating physician. No adverse events led to study drug discontinuation.
INTERPRETATION


8 weeks of grazoprevir plus elbasvir was highly effective for the treatment of acute HCV genotype 1 or 4 infection. The ability to treat acute HCV immediately after diagnosis might help physicians to reach the WHO goal of HCV elimination by 2030.
FUNDING


Merck Sharp and Dohme and Health-Holland.",2019,"INTERPRETATION


8 weeks of grazoprevir plus elbasvir was highly effective for the treatment of acute HCV genotype 1 or 4 infection.","['All 14 patients who were infected with a virus carrying a clinically significant polymorphism in NS5A were cured', '146 patients with a recently acquired HCV infection for eligibility, of whom 86 were enrolled and 80 initiated therapy, all within 6 months after infection', 'chronic hepatitis C virus (HCV) infection', 'Between Feb 15, 2016, and March 2, 2018', 'Adult patients (≥18 years) with acute HCV genotype 1 or 4 infection (duration of infection 26 weeks or less, according to presumed day of infection) were recruited at 15 HIV outpatient clinics in the Netherlands and Belgium', 'The Dutch Acute HCV in HIV']","['grazoprevir plus elbasvir (DAHHS2', 'grazoprevir plus elbasvir', 'grazoprevir 100 mg plus elbasvir']","['concentration impairment', 'dyspepsia', 'headache', 'SVR12', 'mood changes', 'sustained virological response', 'dizziness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0032529', 'cui_str': 'Polymorphism (Genetics)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0524910', 'cui_str': 'Hepatitis C, Chronic'}, {'cui': 'C0042769', 'cui_str': 'Viral Infections'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}]","[{'cui': 'C4080053', 'cui_str': 'grazoprevir'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4080052', 'cui_str': 'elbasvir'}, {'cui': 'C4080449', 'cui_str': 'grazoprevir 100 MG'}]","[{'cui': 'C0235198', 'cui_str': 'Unable to concentrate (finding)'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0085633', 'cui_str': 'Mood swings (finding)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",146.0,0.111107,"INTERPRETATION


8 weeks of grazoprevir plus elbasvir was highly effective for the treatment of acute HCV genotype 1 or 4 infection.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Boerekamps', 'Affiliation': 'Department of Internal Medicine and Infectious Diseases, Erasmus MC, Rotterdam, Netherlands. Electronic address: anneboerekamps@gmail.com.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'De Weggheleire', 'Affiliation': 'Department of Clinical Sciences, Institute of Tropical Medicine Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Guido E', 'Initials': 'GE', 'LastName': 'van den Berk', 'Affiliation': 'Department of Internal Medicine and Infectious Diseases, OLVG, Amsterdam, Netherlands.'}, {'ForeName': 'Fanny N', 'Initials': 'FN', 'LastName': 'Lauw', 'Affiliation': 'Department of Internal Medicine and Infectious Diseases, Slotervaart MC, Amsterdam, Netherlands.'}, {'ForeName': 'Mark A A', 'Initials': 'MAA', 'LastName': 'Claassen', 'Affiliation': 'Department of Internal Medicine and Infectious Diseases, Rijnstate Ziekenhuis, Arnhem, Netherlands.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Posthouwer', 'Affiliation': 'Department of Internal Medicine and Medical Microbiology, Maastricht UMC+, Maastricht, Netherlands.'}, {'ForeName': 'Wouter F', 'Initials': 'WF', 'LastName': 'Bierman', 'Affiliation': 'Department of Internal Medicine and Infectious Diseases, Universitair Medisch Centrum Groningen, Groningen, Netherlands.'}, {'ForeName': 'Sebastiaan J', 'Initials': 'SJ', 'LastName': 'Hullegie', 'Affiliation': 'Department of Internal Medicine and Infectious Diseases, Erasmus MC, Rotterdam, Netherlands.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Popping', 'Affiliation': 'Department of Viroscience, Erasmus MC, Rotterdam, Netherlands.'}, {'ForeName': 'David A C M', 'Initials': 'DACM', 'LastName': 'van de Vijver', 'Affiliation': 'Department of Viroscience, Erasmus MC, Rotterdam, Netherlands.'}, {'ForeName': 'Anthonius S M', 'Initials': 'ASM', 'LastName': 'Dofferhoff', 'Affiliation': 'Department of Internal Medicine and Infectious Diseases, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Gert Jan', 'Initials': 'GJ', 'LastName': 'Kootstra', 'Affiliation': 'Department of Internal Medicine and Infectious Diseases, Medisch Spectrum Twente, Enschede, Netherlands.'}, {'ForeName': 'Eliane M', 'Initials': 'EM', 'LastName': 'Leyten', 'Affiliation': 'Department of Internal Medicine and Infectious Diseases, MC Haaglanden, The Hague, Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'den Hollander', 'Affiliation': 'Department of Internal Medicine and Infectious Diseases, Maasstad Ziekenhuis, Rotterdam, Netherlands.'}, {'ForeName': 'Marjo E', 'Initials': 'ME', 'LastName': 'van Kasteren', 'Affiliation': 'Department of Internal Medicine and Infectious Diseases, Elisabeth-TweeSteden Ziekenhuis, Tilburg, Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Soetekouw', 'Affiliation': 'Department of Internal Medicine and Infectious Diseases, Spaarne Gasthuis, Haarlem, Netherlands.'}, {'ForeName': 'Heidi S M', 'Initials': 'HSM', 'LastName': 'Ammerlaan', 'Affiliation': 'Department of Internal Medicine, Catharina Hospital, Eindhoven, Netherlands.'}, {'ForeName': 'Janke', 'Initials': 'J', 'LastName': 'Schinkel', 'Affiliation': 'Department of Medical Microbiology, Section of Clinical Virology, Academic Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Florence', 'Affiliation': 'Department of Clinical Sciences, Institute of Tropical Medicine Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Joop E', 'Initials': 'JE', 'LastName': 'Arends', 'Affiliation': 'Department of Internal Medicine and Infectious Diseases, Universitair Medisch Centrum Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Bart J A', 'Initials': 'BJA', 'LastName': 'Rijnders', 'Affiliation': 'Department of Internal Medicine and Infectious Diseases, Erasmus MC, Rotterdam, Netherlands.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(18)30414-X']
1331,27216875,Process Evaluation of Making HEPA Policy Practice: A Group Randomized Trial.,"This study examines the link between implementation of Strategies to Enhance Practice (STEPs) and outcomes. Twenty after-school programs (ASPs) participated in an intervention to increase children's accumulation of 30 minutes/day of moderate to vigorous physical activity (MVPA) and quality of snacks served during program time. Outcomes were measured via accelerometer (MVPA) and direct observation (snacks). STEPs implementation data were collected via document review and direct observation. Based on implementation data, ASPs were divided into high/low implementers. Differences between high/low implementers' change in percentage of boys accumulating 30 minutes/day of MVPA were observed. There was no difference between high/low implementers for girls. Days fruits and/or vegetables and water were served increased in the high/low implementation groups, while desserts and sugar-sweetened beverages decreased. Effect sizes (ES) for the difference in changes between the high and low group ranged from low (ES = 0.16) to high (ES = 0.97). Higher levels of implementation led to increased MVPA for boys, whereas girls MVPA benefited from the intervention regardless of high/low implementation. ESs of the difference between high/low implementers indicate that increased implementation of STEPs increases days healthier snacks are served. Programs in the high-implementation group implemented a variety of STEPs strategies, suggesting local adoption/adaptation is key to implementation.",2016,Differences between high/low implementers' change in percentage of boys accumulating 30 minutes/day of MVPA were observed.,[],[],"['via accelerometer (MVPA) and direct observation (snacks', 'vigorous physical activity (MVPA) and quality of snacks served during program time']",[],[],"[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0218382,Differences between high/low implementers' change in percentage of boys accumulating 30 minutes/day of MVPA were observed.,"[{'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Weaver', 'Affiliation': 'University of South Carolina, Columbia, SC, USA weaverrg@mailbox.sc.edu.'}, {'ForeName': 'Justin B', 'Initials': 'JB', 'LastName': 'Moore', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Huberty', 'Affiliation': 'Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Darcy', 'Initials': 'D', 'LastName': 'Freedman', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Brie', 'Initials': 'B', 'LastName': 'Turner-McGrievy', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Beighle', 'Affiliation': 'University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Ward', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Pate', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Saunders', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Brazendale', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Chandler', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Rahma', 'Initials': 'R', 'LastName': 'Ajja', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Becky', 'Initials': 'B', 'LastName': 'Kyryliuk', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Beets', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}]",Health promotion practice,['10.1177/1524839916647331']
1332,30621368,Endocrine response after cervical manipulation and mobilization in people with chronic mechanical neck pain: a randomized controlled trial.,"BACKGROUND


Most of the research on the effects of spinal manipulation on endocrine function has been done on healthy subjects and has yielded contradictory results. The potential role of cervical manual therapy intervention in order to induce changes in the endocrine system has not yet been investigated.
AIM


The aim of this trial is to compare the effects on salivary cortisol levels and clinical outcomes of cervical manipulation versus cervical mobilization or sham manipulation in patients with chronic mechanical neck pain.
DESIGN


Randomized controlled trial.
SETTING


University of Alcala de Henares: outpatient (referrals from office workers).
POPULATION


A total of 83 patients with chronic mechanical neck pain.
METHODS


Participants were randomized to receive one session of cervical manipulation, cervical mobilization, or sham manipulation. The measured variables were salivary cortisol levels, neck pain and disability, pressure pain thresholds (PPT), and cervical range of motion (ROM). They were obtained at baseline, immediately after treatment (except neck disability), and at one-week follow-up (except cortisol).
RESULTS


A significant and comparable increase in cortisol levels was observed immediately after cervical manipulation and mobilization (both P<0.001). Neck disability improved to a similar degree in the cervical manipulation and mobilization groups at the one-week follow-up (both P<0.001). Neck pain was reduced immediately after cervical manipulation (P<0.001), cervical mobilization (P=0.001), and sham manipulation (P<0.001). There were no significant changes in most ROM directions after either treatment. No significant interaction effect was observed for PPT.
CONCLUSIONS


Cervical manipulation and mobilization resulted in a similar increase in cortisol concentrations immediately post-treatment in people with chronic mechanical neck pain. Supraspinal mechanisms may thus play a role in the hypoalgesic effects that follow the application of both interventions.
CLINICAL REHABILITATION IMPACT


The increase in cortisol levels was similar with cervical manipulation and mobilization so induced stress levels can be similar in both interventions.",2019,"Neck pain was reduced immediately after cervical manipulation (p<0.001), cervical mobilization (p=0.001), and sham manipulation (p<0.001).","['healthy subjects', 'University of Alcala de Henares: outpatient (referrals from office workers', 'people with chronic mechanical neck pain', 'Participants', '83 patients with chronic mechanical neck pain', 'patients with chronic mechanical neck pain']","['cervical manipulation versus cervical mobilization or sham manipulation', 'cervical manual therapy intervention', 'cervical manipulation, cervical mobilization, or sham manipulation', 'cervical manipulation and mobilization']","['Neck pain', 'cervical mobilization', 'most ROM directions', 'salivary cortisol levels, neck pain and disability, pressure pain thresholds (PPT), and cervical range of motion (ROM', 'cortisol levels', 'Neck disability', 'cortisol concentrations', 'Endocrine response']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0600576', 'cui_str': 'Cervical Manipulation'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0454525', 'cui_str': 'Manual Therapies'}]","[{'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",83.0,0.161551,"Neck pain was reduced immediately after cervical manipulation (p<0.001), cervical mobilization (p=0.001), and sham manipulation (p<0.001).","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Valera-Calero', 'Affiliation': 'Department of Physical Therapy, University of Alcalá, Madrid, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Lluch Girbés', 'Affiliation': 'Department of Physical Therapy, University of Valencia, Valencia, Spain - enrique.lluch@uv.es.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Gallego-Izquierdo', 'Affiliation': 'Department of Physical Therapy, University of Alcalá, Madrid, Spain.'}, {'ForeName': 'Anneleen', 'Initials': 'A', 'LastName': 'Malfliet', 'Affiliation': 'Department of Physical Therapy, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pecos-Martín', 'Affiliation': 'Department of Physical Therapy, University of Alcalá, Madrid, Spain.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.19.05475-3']
1333,32408610,Changes in Developmental Trajectories of Preschool Children with Autism Spectrum Disorder during Parental Based Intensive Intervention.,"(1) Background: Research highlights the positive effects of early intensive intervention with parent and school involvement for preschool children with Autism Spectrum Disorder (ASD) on general developmental outcomes and social skills in randomized controlled trials. However, given the inter-individual variability in the response to treatment, it is necessary to investigate intervention effects in terms of mediators and moderators in order to explain variability and to highlight mechanisms of change. (2) Methods: 25 children in the experimental group were exposed to early intensive intervention and 14 children in the control group were subjected to ""as usual"" intervention. The initial assessment was obtained at the time of diagnosis (T1) and the follow-up assessment was conducted after 15 months of intervention (T2) in both groups. (3) Results: Participants in the experimental group achieved more prominent gains in both cognitive and socio-interactive skills. The role of specific factors able to predict general quotient and language quotient after intervention were investigated, pointing out the contribution of personal-social and performance abilities. (4) Conclusions: The findings support the importance of parental involvement in targeting ASD core symptoms. Further, results informed our understanding of early predictors in order to identify specific elements to be targeted in the individualized intervention design.",2020,Participants in the experimental group achieved more prominent gains in both cognitive and socio-interactive skills.,"['preschool children with Autism Spectrum Disorder (ASD', 'Preschool Children with Autism']","['early intensive intervention and 14 children in the control group were subjected to ""as usual"" intervention']",['prominent gains in both cognitive and socio-interactive skills'],"[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205402', 'cui_str': 'Prominent'}]",25.0,0.02477,Participants in the experimental group achieved more prominent gains in both cognitive and socio-interactive skills.,"[{'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Bentenuto', 'Affiliation': 'Department of Psychology and Cognitive Science, Laboratory of Observation, Diagnosis and Educational (ODFLAB), University of Trento, Rovereto, 38068 Trento, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Bertamini', 'Affiliation': 'Department of Psychology and Cognitive Science, Laboratory of Observation, Diagnosis and Educational (ODFLAB), University of Trento, Rovereto, 38068 Trento, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Perzolli', 'Affiliation': 'Department of Psychology and Cognitive Science, Laboratory of Observation, Diagnosis and Educational (ODFLAB), University of Trento, Rovereto, 38068 Trento, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Venuti', 'Affiliation': 'Department of Psychology and Cognitive Science, Laboratory of Observation, Diagnosis and Educational (ODFLAB), University of Trento, Rovereto, 38068 Trento, Italy.'}]",Brain sciences,['10.3390/brainsci10050289']
1334,32408413,"The effects of elastic band exercises and nutritional education on frailty, strength, and nutritional intake in elderly women.","PURPOSE


The purpose of this study was to examine the effects of elastic band exercises and nutritional education, as well as to identify the factors influencing frailty, strength, and nutritional intake of elderly women.
METHODS


The subjects in this study were 30 elderly women who were divided into four groups. All groups agreed to participate in four programs: health education only (HE), elastic band exercises only (EX), nutritional education only (NU), and elastic band exercises plus nutritional education (EX+NU). Frailty was evaluated by measuring the frailty factors according to Fried et al. Leg strength was measured using a leg-extension machine. Nutritional intake was assessed by the 24-hour recall method and food records. Nutritional intake was analyzed by CAN Pro 5.0 program.
RESULTS


After three months, the prevalence of frailty significantly decreased in the EX+NU group (P=0.013) compared with that of the HE group (P=0.088). There was significant improvement in leg strength in both the EX (P=0.012) and EX+NU groups (P=0.003) compared with that of the HE group (EX, P=0.005; EX+NU, P=0.002). The nutritional intake significantly decreased in the EX group compared with that of the HE group (P<0.05, P<0.05).
CONCLUSION


The combination of elastic exercises and nutrition education had positive effects on frailty and leg strength, while having negative effects on total calories, carbohydrate, sodium, and iron intake in elderly women. Elastic exercises only had positive effects on leg strength while having negative effects on nutritional intake in elderly women.",2020,"There was significant improvement in leg strength in both the EX (P=0.012) and EX+NU groups (P=0.003) compared with that of the HE group (EX, P=0.005; EX+NU, P=0.002).","['30 elderly women who were divided into four groups', 'elderly women']","['EX+NU', 'health education only (HE), elastic band exercises only (EX), nutritional education only (NU), and elastic band exercises plus nutritional education (EX+NU', 'elastic band exercises and nutritional education', 'Elastic exercises', 'elastic exercises and nutrition education']","['Leg strength', 'Nutritional intake', 'leg strength', 'prevalence of frailty', 'nutritional intake', 'frailty and leg strength', 'total calories, carbohydrate, sodium, and iron intake', 'frailty, strength, and nutritional intake']","[{'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0204934', 'cui_str': 'Nutrition education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0518043', 'cui_str': 'Iron intake'}]",30.0,0.0132178,"There was significant improvement in leg strength in both the EX (P=0.012) and EX+NU groups (P=0.003) compared with that of the HE group (EX, P=0.005; EX+NU, P=0.002).","[{'ForeName': 'Yena', 'Initials': 'Y', 'LastName': 'Bong', 'Affiliation': ''}, {'ForeName': 'Wook', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': ''}]",Journal of exercise nutrition & biochemistry,['10.20463/pan.2020.0007']
1335,30332336,Are the Hands of Veterinary Staff a Reservoir for Antimicrobial-Resistant Bacteria? A Randomized Study to Evaluate Two Hand Hygiene Rubs in a Veterinary Hospital.,"Hand hygiene (HH) is the most successful intervention for hospital infection control. HH rubs with residual action are desired. This study aimed to compare the efficacy of alcohol (A-HH) and lactic acid (LA-HH) rubs, with the latter being marketed as having residual activity. We investigated reductions in bacterial colony-forming units (CFUs), prevalence of antimicrobial-resistant (AMR) organisms, and risk factors for increased counts on the hands of veterinary staff. A randomized, crossover study (53 individuals) was performed in a referral veterinary teaching hospital. Hand plates were taken before, immediately after, and 6 hours after HH. A blinded investigator counted CFUs per plate. Methicillin-resistant  Staphylococcus aureus / pseudintermedius  (MRSA/MRSP), Enterobacteriaceae, and  Pseudomonas  species (spp.) were characterized. Gender, profession, time point, and HH product were included as variables within multivariable analyses. A significant reduction in bacterial CFU was seen immediately after A-HH rub application ( p  < 0.001); however, neither product showed any significant residual action. Veterinarians had higher bacterial CFUs than nurses ( p  = 0.005); contact with patients, rather than the environment, was also associated with higher counts ( p  < 0.001). MRSA, MRSP, Enterobacteriaceae spp., and  Pseudomonas  spp. were detected on 7%, 2%, 14%, and 2% of study participant's hands ( n  = 208 samples), respectively. Frequent HH administration using an A-HH rub was effective at reducing bacterial CFU on hands  in vivo  in this veterinary hospital setting, but its use needs further encouragement in veterinary staff. The high prevalence of antimicrobial bacteria on hands is of concern; they might act as reservoirs for patients, the environment, and in-contact people.",2018,"A significant reduction in bacterial CFU was seen immediately after A-HH rub application (p < 0.001); however, neither product showed any significant residual action.",['53 individuals) was performed in a referral veterinary teaching hospital'],"['Hand hygiene (HH', 'alcohol (A-HH) and lactic acid (LA-HH']","['bacterial colony-forming units (CFUs), prevalence of antimicrobial-resistant (AMR) organisms, and risk factors', 'bacterial CFUs', 'bacterial CFU']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0042614', 'cui_str': 'veterinary'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}]","[{'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0064582', 'cui_str': 'Lactic acid'}]","[{'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C1444089', 'cui_str': 'Resistant organism'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",,0.0234711,"A significant reduction in bacterial CFU was seen immediately after A-HH rub application (p < 0.001); however, neither product showed any significant residual action.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Espadale', 'Affiliation': 'Department of Small Animal Clinical Science, Institute of Veterinary Science, University of Liverpool, Neston, United Kingdom.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Pinchbeck', 'Affiliation': 'Department of Epidemiology and Population Health and Institute of Infection and Global Health, University of Liverpool, Neston, United Kingdom.'}, {'ForeName': 'Nicola J', 'Initials': 'NJ', 'LastName': 'Williams', 'Affiliation': 'Department of Epidemiology and Population Health and Institute of Infection and Global Health, University of Liverpool, Neston, United Kingdom.'}, {'ForeName': 'Dorina', 'Initials': 'D', 'LastName': 'Timofte', 'Affiliation': 'Department of Small Animal Clinical Science, Institute of Veterinary Science, University of Liverpool, Neston, United Kingdom.'}, {'ForeName': 'K Marie', 'Initials': 'KM', 'LastName': 'McIntyre', 'Affiliation': 'Department of Epidemiology and Population Health and Institute of Infection and Global Health, University of Liverpool, Neston, United Kingdom.'}, {'ForeName': 'Vanessa M', 'Initials': 'VM', 'LastName': 'Schmidt', 'Affiliation': 'Department of Small Animal Clinical Science, Institute of Veterinary Science, University of Liverpool, Neston, United Kingdom.'}]","Microbial drug resistance (Larchmont, N.Y.)",['10.1089/mdr.2018.0183']
1336,31586587,Combination of baicalein and ethanol-wet-bonding improves dentin bonding durability.,"OBJECTIVES


This study aimed to investigate the potential of baicalein combined with ethanol-wet bonding (EWB) in improving dentin bonding durability.
METHODS


Sixty caries-free human third molars were randomly allocated into four groups and pretreated with solutions after sectioning and polishing. The pretreatments were prepared via dissolving baicalein in ethanol at concentrations of 0, 0.01%, 0.05% and 0.1% (w/v). Microtensile bond strength (MTBS) test, failure mode analysis and interfacial nanoleakage evaluation were conducted immediately or after thermocycling or 1 month of collagenase aging. In situ zymography, contact angle, antibacterial activity and bioactivity were comprehensively assessed.
RESULTS


Results demonstrated that the three experimental groups exhibited higher MTBS and lower nanoleakage expression regardless of aging. MMP activity within hybrid layer and Streptococcus. mutans biofilm formation were inhibited in the experimental groups in a dose-dependent manner. Baicalein also reduced reactive oxygen species (ROS) expression in human dental pulp cells and resisted adhesive-induced cytotoxicity. Baicalein exhibited remarkable capabilities at concentrations higher than 0.05% (w/v).
CONCLUSION


Baicalein is a prospective candidate as bioactive dentin bonding agent. Combined with EWB, baicalein may form a functional bonding interface, thereby enhancing dentin bond strength and durability.
SIGNIFICANCE


Joint efforts by baicalein and EWB provides a novel therapeutic strategy for obtaining ideal adhesive-dentin interface and prolonging the longevity of restorations.",2019,Baicalein also reduced reactive oxygen species (ROS) expression in human dental pulp cells and resisted adhesive-induced cytotoxicity.,['Sixty caries-free human third molars'],"['solutions after sectioning and polishing', 'EWB, baicalein', 'baicalein and ethanol-wet-bonding', 'baicalein combined with ethanol-wet bonding (EWB']","['mutans biofilm formation', 'reactive oxygen species (ROS) expression', 'contact angle, antibacterial activity and bioactivity', 'Microtensile bond strength (MTBS) test, failure mode analysis and interfacial nanoleakage evaluation', 'dentin bond strength and durability', 'MMP activity', 'dentin bonding durability']","[{'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}]","[{'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0052927', 'cui_str': 'baicalein'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0081786', 'cui_str': 'Biofilms'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0162772', 'cui_str': 'Active Oxygen'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0279516', 'cui_str': 'Anti-Bacterial Agents'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}]",60.0,0.0209834,Baicalein also reduced reactive oxygen species (ROS) expression in human dental pulp cells and resisted adhesive-induced cytotoxicity.,"[{'ForeName': 'Luyao', 'Initials': 'L', 'LastName': 'Yi', 'Affiliation': 'The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) & Key Laboratory for Oral Biomedical Ministry of Education, School & Hospital of Stomatology, Wuhan University, Wuhan, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) & Key Laboratory for Oral Biomedical Ministry of Education, School & Hospital of Stomatology, Wuhan University, Wuhan, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': 'CR&WISCO General Hospital, Wuhan, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Lanzhou Hospital of Stomatology, Lanzhou, China.'}, {'ForeName': 'Hongye', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) & Key Laboratory for Oral Biomedical Ministry of Education, School & Hospital of Stomatology, Wuhan University, Wuhan, China. Electronic address: yanghongye@whu.edu.cn.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) & Key Laboratory for Oral Biomedical Ministry of Education, School & Hospital of Stomatology, Wuhan University, Wuhan, China. Electronic address: huangcui@whu.edu.cn.'}]",Journal of dentistry,['10.1016/j.jdent.2019.103207']
1337,32408412,The effect of short-term creatine intake on blood lactic acid and muscle fatigue measured by accelerometer-based tremor response to acute resistance exercise.,"PURPOSE


The purpose of this study was to investigate the effects of short-term creatine intake on muscle fatigue induced by resistance exercise in healthy adolescent men, i.e., lactic acid concentration and wrist and head tremor measured by an accelerometer.
METHODS


Twelve healthy adolescent men who had no experience with creatine intake were included. The subjects were randomly assigned to the creatine group and the placebo group, followed by 5 days of creatine and placebo intake, and 5 times of 5 sets of leg press, leg extension, bench press, and arm curl exercises at 70% repetition maximum (RM). The lactic acid concentration before and after exercising, rate of perceived exertion (RPE), and accelerometer-based wrist tremor and head tremor during exercise were measured. Subsequently, after 7 days to allow for creatine washout, the same exercise treatment and measurement were performed in each group after switching drug and placebo between the groups.
RESULTS


The level of lactic acid before and after the acute resistance exercise trial was significantly lower in the creatine group than in the placebo group (P <0.05). The mean RPE during the resistance exercise was significantly lower in the creatine group than in the placebo group (P <0.05). There was no difference between the two groups in the mean wrist tremor during resistance exercise, but the mean head tremor values were significantly lower in the creatine group than in the placebo group in the arm curl, the last event of the exercise trials (P <0.05).
CONCLUSION


Short-term creatine intake reduces the blood fatigue factor increased by resistance exercise, and is thought to suppress fatigue, especially in the latter half of resistance exercise. Therefore, these findings indicate that short-term creatine intake can have an improved effect on anaerobic exercise performance.",2020,"There was no difference between the two groups in the mean wrist tremor during resistance exercise, but the mean head tremor values were significantly lower in the creatine group than in the placebo group in the arm curl, the last event of the exercise trials (P <0.05).
","['healthy adolescent men', 'Twelve healthy adolescent men who had no experience with creatine intake were included']","['short-term creatine intake', 'creatine', 'creatine and placebo intake, and 5 times of 5 sets of leg press, leg extension, bench press, and arm curl exercises at 70% repetition maximum (RM', 'placebo']","['mean wrist tremor during resistance exercise', 'rate of perceived exertion (RPE), and accelerometer-based wrist tremor and head tremor during exercise', 'level of lactic acid', 'mean head tremor values', 'mean RPE during the resistance exercise', 'anaerobic exercise performance', 'blood fatigue factor', 'lactic acid concentration', 'blood lactic acid and muscle fatigue', 'lactic acid concentration and wrist and head tremor']","[{'cui': 'C0686747', 'cui_str': 'Well adolescent'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0239882', 'cui_str': 'Head tremor'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0853170', 'cui_str': 'Blood lactic acid'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}]",12.0,0.0980171,"There was no difference between the two groups in the mean wrist tremor during resistance exercise, but the mean head tremor values were significantly lower in the creatine group than in the placebo group in the arm curl, the last event of the exercise trials (P <0.05).
","[{'ForeName': 'Sinwook', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Gyuseog', 'Initials': 'G', 'LastName': 'Hong', 'Affiliation': ''}, {'ForeName': 'Wonil', 'Initials': 'W', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Jaeseong', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Nahyun', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Hyejoon', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Jonghoon', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': ''}]",Journal of exercise nutrition & biochemistry,['10.20463/pan.2020.0006']
1338,30606271,Modulation of anterior cingulate cortex reward and penalty signalling in medication-naive young-adult subjects with depressive symptoms following acute dose lurasidone.,"BACKGROUND


Aberrations in reward and penalty processing are implicated in depression and putatively reflect altered dopamine signalling. This study exploits the advantages of a placebo-controlled design to examine how a novel D2 antagonist with adjunctive antidepressant properties modifies activity in the brain's reward network in depression.
METHODS


We recruited 43 medication-naïve subjects across the range of depression severity (Beck's Depression Inventory-II score range: 0-43), including healthy volunteers, as well as people meeting full-criteria for major depressive disorder. In a double-blind placebo-controlled cross-over design, all subjects received either placebo or lurasidone (20 mg) across two visits separated by 1 week. Functional magnetic resonance imaging with the Monetary Incentive Delay (MID) task assessed reward functions via neural responses during anticipation and receipt of gains and losses. Arterial spin labelling measured cerebral blood flow (CBF) at rest.
RESULTS


Lurasidone altered fronto-striatal activity during anticipation and outcome phases of the MID task. A significant three-way Medication-by-Depression severity-by-Outcome interaction emerged in the anterior cingulate cortex (ACC) after correction for multiple comparisons. Follow-up analyses revealed significantly higher ACC activation to losses in high- v. low depression participants in the placebo condition, with a normalisation by lurasidone. This effect could not be accounted for by shifts in resting CBF.
CONCLUSIONS


Lurasidone acutely normalises reward processing signals in individuals with depressive symptoms. Lurasidone's antidepressant effects may arise from reducing responses to penalty outcomes in individuals with depressive symptoms.",2019,"Follow-up analyses revealed significantly higher ACC activation to losses in high- v. low depression participants in the placebo condition, with a normalisation by lurasidone.","[""43 medication-naïve subjects across the range of depression severity (Beck's Depression Inventory-II score range: 0-43), including healthy volunteers, as well as people meeting full-criteria for major depressive disorder"", 'individuals with depressive symptoms', 'medication-naive young-adult subjects with depressive symptoms following acute dose lurasidone']","['placebo or lurasidone', 'Functional magnetic resonance imaging with the Monetary Incentive Delay (MID) task assessed reward functions', 'placebo']","['Lurasidone altered fronto-striatal activity', 'ACC activation to losses', 'Arterial spin labelling measured cerebral blood flow (CBF']","[{'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C4273555', 'cui_str': 'BDI-II (Beck Depression Inventory Second Edition) score'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C2003424', 'cui_str': 'lurasidone'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0031843', 'cui_str': 'function'}]","[{'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}]",,0.285157,"Follow-up analyses revealed significantly higher ACC activation to losses in high- v. low depression participants in the placebo condition, with a normalisation by lurasidone.","[{'ForeName': 'Selina A', 'Initials': 'SA', 'LastName': 'Wolke', 'Affiliation': ""Department of Child and Adolescent Psychiatry,Institute of Psychiatry, Psychology, and Neuroscience, King's College London,London,UK.""}, {'ForeName': 'Mitul A', 'Initials': 'MA', 'LastName': 'Mehta', 'Affiliation': ""Department of Neuroimaging,Institute of Psychiatry, Psychology, and Neuroscience, King's College London,London,UK.""}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': ""O'Daly"", 'Affiliation': ""Department of Neuroimaging,Institute of Psychiatry, Psychology, and Neuroscience, King's College London,London,UK.""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Zelaya', 'Affiliation': ""Department of Neuroimaging,Institute of Psychiatry, Psychology, and Neuroscience, King's College London,London,UK.""}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Zahreddine', 'Affiliation': 'Department of Psychiatry,Saint-Joseph University,Beirut,Lebanon.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Keren', 'Affiliation': 'Mood Brain and Development Unit, Emotion and Development Branch,National Institute of Mental Health, National Institutes of Health,MD,USA.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': ""O'Callaghan"", 'Affiliation': 'Mood Brain and Development Unit, Emotion and Development Branch,National Institute of Mental Health, National Institutes of Health,MD,USA.'}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""Department of Psychological Medicine,Institute of Psychiatry, Psychology, and Neuroscience, King's College London,London,UK.""}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Leibenluft', 'Affiliation': 'Section on Mood Dysregulation and Neuroscience, Emotion and Development Branch,National Institute of Mental Health, National Institutes of Health,MD,USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Pine', 'Affiliation': 'Section on Development and Affective Neuroscience, Emotion and Development Branch,National Institute of Mental Health,MD,USA.'}, {'ForeName': 'Argyris', 'Initials': 'A', 'LastName': 'Stringaris', 'Affiliation': 'Mood Brain and Development Unit, Emotion and Development Branch,National Institute of Mental Health, National Institutes of Health,MD,USA.'}]",Psychological medicine,['10.1017/S0033291718003306']
1339,31667987,Lung ultrasound-guided treatment in ambulatory patients with heart failure: a randomized controlled clinical trial (LUS-HF study).,"AIMS


Lung ultrasound (LUS) is a useful tool with which to assess subclinical pulmonary congestion and to stratify the prognosis of patients with heart failure (HF). The aim of this study was to evaluate whether an LUS-guided follow-up protocol improves the outcomes of patients with HF.
METHODS AND RESULTS


In this single-blind clinical trial, 123 patients admitted for HF were randomized to either a standard follow-up (n = 62, control group) or a LUS-guided follow-up (n = 61, LUS group). The primary endpoint was a composite of urgent visit, hospitalization for worsening HF and death during follow-up. Visits were scheduled at 14, 30, 90 and 180 days after discharge. Treating physicians were encouraged to modify diuretic therapy in accordance with the number of B-lines recorded by LUS. The mean ± standard deviation (SD) age of the patients was 69 ± 12 years and 72% were male. The mean ± SD left ventricular ejection fraction was 39 ± 14%. The hazard ratio for the primary outcome in the LUS group was 0.518 [95% confidence interval (CI) 0.268-0.998; P = 0.049], mainly resulting from a decrease in the number of urgent visits for worsening HF. The number of patients needed to treat to avoid an event was 5 (95% CI 3-62). Other secondary endpoints such as N-terminal pro-B-type natriuretic peptide reduction were not achieved. The safety parameters were similar in the two groups. Patients in the LUS group received more loop diuretics [51 (91%) vs. 42 (75%); P = 0.02] and showed an improvement in the distance achieved in the 6-min walking test [60 m (interquartile range: 29-125 m) vs. 37 m (interquartile range: 5-70 m); P = 0.023].
CONCLUSIONS


Tailored LUS-guided diuretic treatment of pulmonary congestion in this proof-of-concept study reduced the number of decompensations and improved walking capacity in patients with HF. LUS is a non-invasive, safe and easy-to-use technique with potential clinical applicability to guide pulmonary congestion treatment in patients with HF.",2019,"LUS is a non-invasive, safe and easy-to-use technique with potential clinical applicability to guide pulmonary congestion treatment in patients with HF.","['123 patients admitted for HF', 'patients with HF', 'patients with heart failure (HF', 'ambulatory patients with heart failure', 'age of the patients was 69\u2009±\u200912\u2009years and 72% were male']","['Lung ultrasound-guided treatment', 'LUS-guided follow-up protocol', 'LUS-guided follow-up', 'loop diuretics', 'Lung ultrasound (LUS', 'LUS']","['number of decompensations and improved walking capacity', 'number of urgent visits for worsening HF', 'mean\u2009±\u2009SD left ventricular ejection fraction', 'composite of urgent visit, hospitalization for worsening HF and death', 'distance achieved in the 6-min walking test', 'N-terminal pro-B-type natriuretic peptide reduction', 'hazard ratio', 'mean\u2009±\u2009standard deviation (SD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0231187', 'cui_str': 'Decompensation (finding)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for (contextual qualifier) (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",123.0,0.137983,"LUS is a non-invasive, safe and easy-to-use technique with potential clinical applicability to guide pulmonary congestion treatment in patients with HF.","[{'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Rivas-Lasarte', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Álvarez-García', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Fernández-Martínez', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Maestro', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'López-López', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Solé-González', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Pirla', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Mesado', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Mirabet', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Fluvià', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Vicens', 'Initials': 'V', 'LastName': 'Brossa', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Sionis', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Eulàlia', 'Initials': 'E', 'LastName': 'Roig', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Cinca', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}]",European journal of heart failure,['10.1002/ejhf.1604']
1340,32408551,Changing Exposure Perceptions: A Randomized Controlled Trial of an Intervention with Smoking Parents.,"Children who live with smokers are at risk of poor health, and of becoming smokers themselves. Misperceptions of the nature of tobacco smoke exposure have been demonstrated among parents, resulting in continued smoking in their children's environment. This study aimed to change parents' perceptions of exposure by providing information on second- and third-hand exposure and personalised information on children's exposure [NIH registry (NCT02867241)]. One hundred and fifty-nine families with a child < 8 years and at least one smoking parent were randomized into intervention (69), control (70), and enhanced control (20) groups. Reported exposure, parental smoking details, and a child hair sample were obtained at the start of the study and 6-8 months later. Parental perceptions of exposure (PPE) were assessed via a questionnaire. The intervention consisted of motivational interviews, feedback of home air quality and child's hair nicotine level, and information brochures. PPE were significantly higher at the study end (94.6 ± 17.6) compared to study beginning (86.5 ± 19.3) in intervention and enhanced control groups (t(72) = -3.950;  p  < 0.001). PPE at study end were significantly higher in the intervention group compared to the regular control group ( p  = 0.020). There was no significant interaction between time and group. Parallel changes in parental smoking behaviour were found. Parental perceptions of exposure were increased significantly post intervention, indicating that they can be altered. By making parents more aware of exposure and the circumstances in which it occurs, we can help parents change their smoking behaviour and better protect their children.",2020,PPE at study end were significantly higher in the intervention group compared to the regular control group ( p  = 0.020).,"['Children who live with smokers', 'One hundred and fifty-nine families with a child < 8 years and at least one smoking parent']","[""motivational interviews, feedback of home air quality and child's hair nicotine level, and information brochures""]","['parental smoking behaviour', 'PPE', 'Parental perceptions of exposure (PPE']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C2371710', 'cui_str': 'Air Quality'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0202431', 'cui_str': 'Nicotine measurement'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",159.0,0.0176672,PPE at study end were significantly higher in the intervention group compared to the regular control group ( p  = 0.020).,"[{'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Myers', 'Affiliation': 'Department of Health Promotion, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Ramat Aviv, Tel Aviv 6997801, Israel.'}, {'ForeName': 'Shoshana', 'Initials': 'S', 'LastName': 'Shiloh', 'Affiliation': 'School of Psychological Sciences, Gershon H. Gordon Faculty of Social Sciences, Tel Aviv University, Ramat Aviv, Tel Aviv 6997801, Israel.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Zucker', 'Affiliation': 'Department of Statistics, Hebrew University, Mount Scopus, Jerusalem 9190501, Israel.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Rosen', 'Affiliation': 'Department of Health Promotion, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Ramat Aviv, Tel Aviv 6997801, Israel.'}]",International journal of environmental research and public health,['10.3390/ijerph17103349']
1341,32408644,Efficacy of the Rotary Instrument XP-Endo Finisher in the Removal of Calcium Hydroxide Intracanal Medicament in Combination with Different Irrigation Techniques: A Microtomographic Study.,"OBJECTIVES


This study aims to evaluate the efficacy of the rotary instrument XP-endo Finisher for the removal of Ca(OH) 2  aided by different irrigation regimens.
METHODS


Sixteen double-rooted upper premolar human teeth were selected for the study. Thirty-two canals were prepared using a ProTaper Next rotary system up to X3. Then, the canals were filled with Ca(OH) 2 . The volume of Ca(OH) 2  inside the canals was measured by microcomputed tomography (micro-CT). After that, the teeth were randomly allocated into two experimental groups, i.e., A and B (n = 16 canals). In group A, Ca(OH) 2  was removed using the master apical file (X3). In group B, Ca(OH) 2  was removed using a XP-endo finisher. In half of both groups (n = 8), syringe irrigation (SI) was used, while passive ultrasonic irrigation (PUI) was used for the other half. After removal, the remaining volume of Ca(OH) 2  was measured. All data were statistically analyzed using two-way ANOVA with Tukey's post hoc test.
RESULTS


The percentages of remaining Ca(OH) 2  in the apical thirds of all canals were significantly higher as compared with the middle and coronal thirds in all groups ( p  < 0.05). There was no significant difference between different files and techniques ( p  > 0.05).
CLINICAL SIGNIFICANCE


This study presents a new method for the removal of Ca(OH) 2  from root canals.",2020,The percentages of remaining Ca(OH) 2  in the apical thirds of all canals were significantly higher as compared with the middle and coronal thirds in all groups ( p  < 0.05).,['Sixteen double-rooted upper premolar human teeth were selected for the study'],"['syringe irrigation (SI', 'rotary instrument XP-endo Finisher', 'Calcium Hydroxide', 'Rotary Instrument XP-Endo Finisher']","['volume of Ca(OH', 'percentages of remaining Ca(OH']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",32.0,0.0135907,The percentages of remaining Ca(OH) 2  in the apical thirds of all canals were significantly higher as compared with the middle and coronal thirds in all groups ( p  < 0.05).,"[{'ForeName': 'Jameela', 'Initials': 'J', 'LastName': 'Denna', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, King Abdulaziz University, Jeddah 21589, Saudi Arabia.'}, {'ForeName': 'Lubna A', 'Initials': 'LA', 'LastName': 'Shafie', 'Affiliation': 'Faculty of Oral and Dental Medicine, Cairo University affiliated to Faculty of Dentistry, King Abdulaziz University, Jeddah 21589, Saudi Arabia.'}, {'ForeName': 'Loai', 'Initials': 'L', 'LastName': 'Alsofi', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, King Abdulaziz University, Jeddah 21589, Saudi Arabia.'}, {'ForeName': 'Mey', 'Initials': 'M', 'LastName': 'Al-Habib', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, King Abdulaziz University, Jeddah 21589, Saudi Arabia.'}, {'ForeName': 'Emad', 'Initials': 'E', 'LastName': 'AlShwaimi', 'Affiliation': 'Endodontic Division, Restorative Dental Sciences Department, College of Dentistry, Imam Abdulrahman Bin Faisal University, Dammam 31441, Saudi Arabia.'}]","Materials (Basel, Switzerland)",['10.3390/ma13102222']
1342,31674219,Are self-efficacy measures confounded with motivation? An experimental test.,"Standard measures of self-efficacy (SE) may confound  perceived capability  and  motivation  because respondents interpret the word ""can"" as ""will"".  Objective:  To test whether priming for the meaning of the word ""can"" changes self-efficacy ratings.  Design:  In an experimental test, 134 university students responded to an on-line standardized measure of exercise SE and provided definitions of the words ""can"" and ""will"". One month later participants were randomized to complete (a) the same questionnaire (control), (b) the same questionnaire but with presentation of each participant's definition of ""can"" prior to the SE measure (definition priming), or (c) the same questionnaire but with SE items (""I can exercise…"") placed side-by-side with behavioral intention items (""I will exercise…"") (side-by-side priming).  Results:  SE increased relative to controls for side-by-side (b = 12.08,  SE  = 2.70,  p <.01) but not definition priming (ns), with the former even stronger among participants ( n  = 91) who provided strict (i.e., literal) rather than liberal definitions of ""can"" (b = 15.38,  SE  = 3.21,  p <.001).  Conclusion:  Priming of the meaning of the word ""can"" led to increases in self-efficacy ratings among those who hold a literal meaning of the word ""can"". This suggests that for many respondents standard assessments of SE may be confounded by motivation.",2020,"increased relative to controls for side-by-side (b = 12.08,  SE  = 2.70,  p <.01) but not definition priming (ns), with the former even stronger among participants ( n  = 91) who provided strict (i.e., literal) rather than liberal definitions of ""can"" (b = 15.38,  SE  = 3.21,  p <.001).  ",['134 university students'],"['can"" prior to the SE measure (definition priming), or (c) the same questionnaire but with SE items (""I can exercise…"") placed side-by-side with behavioral intention items (""I will exercise…', 'SE']",['self-efficacy ratings'],"[{'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",134.0,0.0141905,"increased relative to controls for side-by-side (b = 12.08,  SE  = 2.70,  p <.01) but not definition priming (ns), with the former even stronger among participants ( n  = 91) who provided strict (i.e., literal) rather than liberal definitions of ""can"" (b = 15.38,  SE  = 3.21,  p <.001).  ","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Williams', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Dunsiger', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Emerson', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dionne', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Rhodes', 'Affiliation': 'Behavioural Medicine Laboratory, School of Exercise Science, Physical and Health Education, University of Victoria, Victoria, Canada.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Beauchamp', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, Canada.'}]",Psychology & health,['10.1080/08870446.2019.1683179']
1343,31676222,"Odanacatib for the treatment of postmenopausal osteoporosis: results of the LOFT multicentre, randomised, double-blind, placebo-controlled trial and LOFT Extension study.","BACKGROUND


Odanacatib, a cathepsin K inhibitor, reduces bone resorption while maintaining bone formation. Previous work has shown that odanacatib increases bone mineral density in postmenopausal women with low bone mass. We aimed to investigate the efficacy and safety of odanacatib to reduce fracture risk in postmenopausal women with osteoporosis.
METHODS


The Long-term Odanacatib Fracture Trial (LOFT) was a multicentre, randomised, double-blind, placebo-controlled, event-driven study at 388 outpatient clinics in 40 countries. Eligible participants were women aged at least 65 years who were postmenopausal for 5 years or more, with a femoral neck or total hip bone mineral density T-score between -2·5 and -4·0 if no previous radiographic vertebral fracture, or between -1·5 and -4·0 with a previous vertebral fracture. Women with a previous hip fracture, more than one vertebral fracture, or a T-score of less than -4·0 at the total hip or femoral neck were not eligible unless they were unable or unwilling to use approved osteoporosis treatment. Participants were randomly assigned (1:1) to either oral odanacatib (50 mg once per week) or matching placebo. Randomisation was done using an interactive voice recognition system after stratification for previous radiographic vertebral fracture, and treatment was masked to study participants, investigators and their staff, and sponsor personnel. If the study completed before 5 years of double-blind treatment, consenting participants could enrol in a double-blind extension study (LOFT Extension), continuing their original treatment assignment for up to 5 years from randomisation. Primary endpoints were incidence of vertebral fractures as assessed using radiographs collected at baseline, 6 and 12 months, yearly, and at final study visit in participants for whom evaluable radiograph images were available at baseline and at least one other timepoint, and hip and non-vertebral fractures adjudicated as being a result of osteoporosis as assessed by clinical history and radiograph. Safety was assessed in participants who received at least one dose of study drug. The adjudicated cardiovascular safety endpoints were a composite of cardiovascular death, myocardial infarction, or stroke, and new-onset atrial fibrillation or flutter. Individual cardiovascular endpoints and death were also assessed. LOFT and LOFT Extension are registered with ClinicalTrials.gov (number NCT00529373) and the European Clinical Trials Database (EudraCT number 2007-002693-66).
FINDINGS


Between Sept 14, 2007, and Nov 17, 2009, we randomly assigned 16 071 evaluable patients to treatment: 8043 to odanacatib and 8028 to placebo. After a median follow-up of 36·5 months (IQR 34·43-40·15) 4297 women assigned to odanacatib and 3960 assigned to placebo enrolled in LOFT Extension (total median follow-up 47·6 months, IQR 35·45-60·06). In LOFT, cumulative incidence of primary outcomes for odanacatib versus placebo were: radiographic vertebral fractures 3·7% (251/6770) versus 7·8% (542/6910), hazard ratio (HR) 0·46, 95% CI 0·40-0·53; hip fractures 0·8% (65/8043) versus 1·6% (125/8028), 0·53, 0·39-0·71; non-vertebral fractures 5·1% (412/8043) versus 6·7% (541/8028), 0·77, 0·68-0·87; all p<0·0001. Combined results from LOFT plus LOFT Extension for cumulative incidence of primary outcomes for odanacatib versus placebo were: radiographic vertebral fractures 4·9% (341/6909) versus 9·6% (675/7011), HR 0·48, 95% CI 0·42-0·55; hip fractures 1·1% (86/8043) versus 2·0% (162/8028), 0·52, 0·40-0·67; non-vertebral fractures 6·4% (512/8043) versus 8·4% (675/8028), 0·74, 0·66-0·83; all p<0·0001. In LOFT, the composite cardiovascular endpoint of cardiovascular death, myocardial infarction, or stroke occurred in 273 (3·4%) of 8043 patients in the odanacatib group versus 245 (3·1%) of 8028 in the placebo group (HR 1·12, 95% CI 0·95-1·34; p=0·18). New-onset atrial fibrillation or flutter occurred in 112 (1·4%) of 8043 patients in the odanacatib group versus 96 (1·2%) of 8028 in the placebo group (HR 1·18, 0·90-1·55; p=0·24). Odanacatib was associated with an increased risk of stroke (1·7% [136/8043] vs 1·3% [104/8028], HR 1·32, 1·02-1·70; p=0·034), but not myocardial infarction (0·7% [60/8043] vs 0·9% [74/8028], HR 0·82, 0·58-1·15; p=0·26). The HR for all-cause mortality was 1·13 (5·0% [401/8043] vs 4·4% [356/8028], 0·98-1·30; p=0·10). When data from LOFT Extension were included, the composite of cardiovascular death, myocardial infarction, or stroke occurred in significantly more patients in the odanacatib group than in the placebo group (401 [5·0%] of 8043 vs 343 [4·3%] of 8028, HR 1·17, 1·02-1·36; p=0·029, as did stroke (2·3% [187/8043] vs 1·7% [137/8028], HR 1·37, 1·10-1·71; p=0·0051).
INTERPRETATION


Odanacatib reduced the risk of fracture, but was associated with an increased risk of cardiovascular events, specifically stroke, in postmenopausal women with osteoporosis. Based on the overall balance between benefit and risk, the study's sponsor decided that they would no longer pursue development of odanacatib for treatment of osteoporosis.
FUNDING


Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc, Kenilworth, NJ, USA.",2019,"Odanacatib was associated with an increased risk of stroke (1·7% [136/8043] vs 1·3% [104/8028],","['consenting participants could enrol in a double-blind extension study (LOFT Extension), continuing their original treatment assignment for up to 5 years from randomisation', 'postmenopausal women with low bone mass', 'participants who received at least one dose of study drug', 'Women with a previous hip fracture, more than one vertebral fracture, or a T-score of less than -4·0 at the total hip or femoral neck were not eligible unless they were unable or unwilling to use approved osteoporosis treatment', 'postmenopausal women with osteoporosis', '388 outpatient clinics in 40 countries', 'Between Sept 14, 2007, and Nov 17, 2009, we randomly assigned 16\u2008071 evaluable patients to treatment: 8043 to odanacatib and 8028 to', 'postmenopausal osteoporosis', 'Eligible participants were women aged at least 65 years who were postmenopausal for 5 years or more, with a femoral neck or total hip bone mineral density T-score between -2·5 and -4·0 if no previous radiographic vertebral fracture, or between -1·5 and -4·0 with a previous vertebral fracture']","['LOFT plus LOFT', 'odanacatib', 'placebo', 'interactive voice recognition system', 'Odanacatib', 'oral odanacatib (50 mg once per week) or matching placebo']","['risk of stroke', 'Safety', 'composite of cardiovascular death, myocardial infarction, or stroke, and new-onset atrial fibrillation or flutter', 'efficacy and safety', 'incidence of vertebral fractures', 'risk of cardiovascular events', 'fracture risk', 'composite of cardiovascular death, myocardial infarction, or stroke', 'radiographic vertebral fractures', 'bone mineral density', 'myocardial infarction', 'Individual cardiovascular endpoints and death', 'hazard ratio (HR', 'New-onset atrial fibrillation or flutter', 'composite cardiovascular endpoint of cardiovascular death, myocardial infarction, or stroke']","[{'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0563050', 'cui_str': 'Attic (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C4303745', 'cui_str': 'Treatment for osteoporosis (procedure)'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal Bone Loss'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}]","[{'cui': 'C0563050', 'cui_str': 'Attic (environment)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2351970', 'cui_str': 'odanacatib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.693385,"Odanacatib was associated with an increased risk of stroke (1·7% [136/8043] vs 1·3% [104/8028],","[{'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'McClung', 'Affiliation': 'Oregon Osteoporosis Center, Portland, OR, USA; Mary MacKillop Center for Health Research, Australian Catholic Unversity, Melbourne, VIC, Australia.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': ""O'Donoghue"", 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Socrates E', 'Initials': 'SE', 'LastName': 'Papapoulos', 'Affiliation': 'Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Bone', 'Affiliation': 'Michigan Bone and Mineral Clinic, Detroit, MI, USA.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Langdahl', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Kenneth G', 'Initials': 'KG', 'LastName': 'Saag', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Reid', 'Affiliation': 'University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Douglas P', 'Initials': 'DP', 'LastName': 'Kiel', 'Affiliation': 'Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Cavallari', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'de Villiers', 'Affiliation': 'Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Ling', 'Affiliation': 'Peking Union Medical College, Dongcheng, Beijing, China.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Lippuner', 'Affiliation': 'Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Reginster', 'Affiliation': 'Department of Public Health, Epidemiology and Health Economics and WHO Collaborating Centre for Public Health Aspects of Musculoskeletal Health and Aging, University of Liège, Liège, Belgium.'}, {'ForeName': 'Jose Adolfo', 'Initials': 'JA', 'LastName': 'Rodriguez-Portales', 'Affiliation': 'Pontifical Catholic University of Chile, Santiago, Chile.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Roux', 'Affiliation': 'Paris Descartes University, Cochin Hospital, Paris, France.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Zanchetta', 'Affiliation': 'Institute of Metabolic Research, Buenos Aires, Argentina.'}, {'ForeName': 'Cristiano A F', 'Initials': 'CAF', 'LastName': 'Zerbini', 'Affiliation': 'Paulista Center of Investigations, São Paulo, Brazil.'}, {'ForeName': 'Jeong-Gun', 'Initials': 'JG', 'LastName': 'Park', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'KyungAh', 'Initials': 'K', 'LastName': 'Im', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Cange', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Laura T', 'Initials': 'LT', 'LastName': 'Grip', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Heyden', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'DaSilva', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Dosinda', 'Initials': 'D', 'LastName': 'Cohn', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Rachid', 'Initials': 'R', 'LastName': 'Massaad', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Boyd B', 'Initials': 'BB', 'LastName': 'Scott', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Verbruggen', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Gurner', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Miller', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Micki L', 'Initials': 'ML', 'LastName': 'Blair', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Adam B', 'Initials': 'AB', 'LastName': 'Polis', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'S Aubrey', 'Initials': 'SA', 'LastName': 'Stoch', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Santora', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Lombardi', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Albert T', 'Initials': 'AT', 'LastName': 'Leung', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Keith D', 'Initials': 'KD', 'LastName': 'Kaufman', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA. Electronic address: keith_kaufman@merck.com.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30346-8']
1344,31650069,Graded exposure treatment for adolescents with chronic pain (GET Living): Protocol for a randomized controlled trial enhanced with single case experimental design.,"Chronic musculoskeletal pain in adolescence is a significant public health concern with 3-5% of adolescents suffering from significant pain-related disability. Pain-related fear and avoidance of activities has been found to have a significant influence on pain outcomes in children and adolescents and is a risk factor for less favorable response to treatment. To address this need, we developed graded exposure treatment for youth with chronic pain (GET Living). We describe the rationale, design, and implementation of a two-group randomized controlled trial (RCT) enhanced with single-case experimental design (SCED) methodology with a sample of 74 adolescents with chronic musculosketal pain and their parent caregivers. GET Living includes education, behavioral exposures, and parent intervention jointly delivered by pain psychology and physical therapy providers. The multidisciplinary pain management control group includes pain psychology delivered education and pain self-management skills training (e.g., relaxation, cognitive skills) and separate physical therapy. Assessments include brief daily diaries (baseline to discharge, 7-days at 3-month and 6-month follow-up), comprehensive in-person evaluations at baseline and discharge, and questionnaire across all time points (baseline, discharge, 3-month and 6-month follow-up). Primary outcome is pain-related fear avoidance. Secondary outcome is functional disability. We also outline all additional outcomes, exploratory outcomes, covariates, and implementation measures. The objective is to offer a mechanism-based, targeted intervention to youth with musculoskeletal pain to enhance likelihood of return to function.",2019,Pain-related fear and avoidance of activities has been found to have a significant influence on pain outcomes in children and adolescents and is a risk factor for less favorable response to treatment.,"['adolescents with chronic pain (GET Living', 'youth with chronic pain (GET Living', 'children and adolescents', '74 adolescents with chronic musculosketal pain and their parent caregivers']","['multidisciplinary pain management control group includes pain psychology delivered education and pain self-management skills training (e.g., relaxation, cognitive skills) and separate physical therapy', 'single-case experimental design (SCED) methodology', 'Graded exposure treatment']","['pain outcomes', 'brief daily diaries (baseline to discharge, 7-days at 3-month and 6-month follow-up), comprehensive in-person evaluations at baseline and discharge, and questionnaire across all time points (baseline, discharge, 3-month and 6-month follow-up', 'pain-related fear avoidance', 'functional disability', 'Chronic musculoskeletal pain']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0015320', 'cui_str': 'Experimental Design'}, {'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}]",74.0,0.100904,Pain-related fear and avoidance of activities has been found to have a significant influence on pain outcomes in children and adolescents and is a risk factor for less favorable response to treatment.,"[{'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Simons', 'Affiliation': 'Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Harrison', 'Affiliation': 'Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Shannon F', 'Initials': 'SF', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Marissa S', 'Initials': 'MS', 'LastName': 'Heirich', 'Affiliation': 'Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Loecher', 'Affiliation': 'Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Derek B', 'Initials': 'DB', 'LastName': 'Boothroyd', 'Affiliation': 'Quantitative Statistical Unit, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Johan W S', 'Initials': 'JWS', 'LastName': 'Vlaeyen', 'Affiliation': 'Research Group Health Psychology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Rikard K', 'Initials': 'RK', 'LastName': 'Wicksell', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Schofield', 'Affiliation': 'Center for Economic Impacts of Genomic Medicine, Department of Economics, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Korey K', 'Initials': 'KK', 'LastName': 'Hood', 'Affiliation': 'Division of Endocrinology and Diabetes, Diabetes Research Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Orendurff', 'Affiliation': ""Motion and Sports Performance Lab, Department of Orthopedic Sports Medicine, Lucile Packard Children's Hospital, Stanford, CA, USA.""}, {'ForeName': 'Salinda', 'Initials': 'S', 'LastName': 'Chan', 'Affiliation': ""Motion and Sports Performance Lab, Department of Orthopedic Sports Medicine, Lucile Packard Children's Hospital, Stanford, CA, USA.""}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Lyons', 'Affiliation': ""Motion and Sports Performance Lab, Department of Orthopedic Sports Medicine, Lucile Packard Children's Hospital, Stanford, CA, USA.""}]",Contemporary clinical trials communications,['10.1016/j.conctc.2019.100448']
1345,31567725,Extended Prophylaxis With Nevirapine Does Not Affect Growth in HIV-Exposed Infants.,"BACKGROUND


Effects of prolonged nevirapine prophylaxis exposure on growth among HIV-exposed uninfected (HEU) infants are unknown. This study examines the impact of extended nevirapine prophylaxis from 6 weeks to 6 months on the growth of HEU infants followed for 18 months and also identifies correlates of incident wasting, stunting, underweight, and low head circumference in the HPTN 046 trial.
METHODS


Intention-to-treat analysis examined the effect of extended nevirapine exposure on: weight-for-age Z-score, length-for-age Z-score, weight-for-length Z-score, and head circumference-for-age Z-score. Multivariable linear mixed-effects and Cox proportional hazard models were used to compare growth outcomes between the study arms and identify correlates of incident adverse growth outcomes, respectively.
RESULTS


Compared to placebo, extended prophylactic nevirapine given daily from 6 weeks to 6 months did not affect growth in HEU breastfeeding (BF) infants over time (treatment × time: P > 0.05). However, overall growth declined over time (time effect: P < 0.01) when compared with WHO general population norms. Male sex was associated with higher risk of all adverse growth outcomes (P < 0.05), whereas short BF duration was associated with wasting (P = 0.03). Maternal antiretroviral therapy exposure was protective against underweight (P = 0.02). Zimbabwe tended to have worse growth outcomes especially stunting, compared to South Africa, Uganda and Tanzania (P < 0.05).
CONCLUSIONS


It is reassuring that prolonged exposure to nevirapine for prevention-of-mother-to-child HIV transmission does not restrict growth. However, targeted interventions are needed to improve growth outcomes among at-risk HEU infants (i.e., male sex, short BF duration, lack of maternal antiretroviral therapy exposure, and resident in Zimbabwe).",2019,"Zimbabwe tended to have worse growth outcomes especially stunting, compared to South Africa, Uganda and Tanzania (p<.05).
","['HEU infants followed for 18 months and also identifies correlates of incident wasting, stunting, underweight, and low head circumference in the HPTN 046 trial']","['extended nevirapine', 'nevirapine', 'nevirapine prophylaxis', 'nevirapine prophylaxis exposure', 'placebo, extended prophylactic nevirapine', 'Zimbabwe']","[' weight-for-age Z-score (WAZ), length-for-age Z-score (LAZ), weight-for-length Z-score (WLZ) and head circumference-for-age (HCZ', 'overall growth', 'short BF duration']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}]","[{'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",,0.0927972,"Zimbabwe tended to have worse growth outcomes especially stunting, compared to South Africa, Uganda and Tanzania (p<.05).
","[{'ForeName': 'Carolyne', 'Initials': 'C', 'LastName': 'Onyango-Makumbi', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration/MU-JHU CARE LTD, Kampala, Uganda.'}, {'ForeName': 'Arthur H', 'Initials': 'AH', 'LastName': 'Owora', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration/MU-JHU CARE LTD, Kampala, Uganda.'}, {'ForeName': 'Ramadhani S', 'Initials': 'RS', 'LastName': 'Mwiru', 'Affiliation': 'Division of Global HIV/AIDS, Center for Global Health, U.S. Centers for Disease Control and Prevention, Dar es Salaam, Tanzania.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Mwatha', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention (SCHARP), Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Alicia M', 'Initials': 'AM', 'LastName': 'Young', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention (SCHARP), Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Dhayendre', 'Initials': 'D', 'LastName': 'Moodley', 'Affiliation': 'Department of Obstetrics and Gynaecology, Centre for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R Mandela School of Medicine, University of KwaZulu Natal, Durban, South Africa.'}, {'ForeName': 'Hoosen M', 'Initials': 'HM', 'LastName': 'Coovadia', 'Affiliation': 'Maternal Adolescent and Child Health (MatCH), University of the Witwatersrand, South Africa.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Stranix-Chibanda', 'Affiliation': 'College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Manji', 'Affiliation': 'Department of Paediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Maldonado', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Stanford University, School of Medicine, Stanford, CA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Richardson', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore,MD.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Andrew', 'Affiliation': 'Family Health International, Durham, NC.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'George', 'Affiliation': 'Family Health International, Durham, NC.'}, {'ForeName': 'Wafaie', 'Initials': 'W', 'LastName': 'Fawzi', 'Affiliation': 'Departments of Global Health and Population, Nutrition and Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, MD.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002145']
1346,32408846,A randomized controlled trial of acceptance and commitment therapy for psychological distress among persons with traumatic brain injury.,"Psychological distress is common in persons with traumatic brain injury (TBI) but treatments remain underdeveloped. This randomized controlled trial of Acceptance and Commitment Therapy (ACT) was designed to address this gap. Ninety-three persons with medically-documented complicated mild to severe TBI, normal-to-mildly impaired memory, and clinically significant psychological distress in the chronic phase of recovery were randomized to receive eight weeks of ACT (manualized with adaptations to address TBI-related cognitive impairments) or a single session of needs assessment, brief counseling/education, and referral. The ACT group showed significantly greater reduction of psychological distress (Brief Symptom Inventory 18) and demonstrated improvements in psychological flexibility and commitment to action (Acceptance and Action Questionnaire-II (AAQ-II) scores). The number of treatment responders (post-treatment BSI 18 GSI T scores <63) was larger in the ACT group than in the control group. Entry of AAQ-II scores into the model of between-group differences in BSI 18 GSI T scores indicated that core ACT processes explained the variance in treatment group outcomes. Provision of ACT reduces psychological distress in persons with TBI in the chronic phase of recovery when adaptations are made to accommodate TBI-related cognitive impairments. Additional clinical trials with a structurally equivalent control group are needed.",2020,The ACT group showed significantly greater reduction of psychological distress (Brief Symptom Inventory 18) and demonstrated improvements in psychological flexibility and commitment to action (Acceptance and Action Questionnaire-II (AAQ-II) scores).,"['Ninety-three persons with medically-documented complicated mild to severe TBI, normal-to-mildly impaired memory, and clinically significant psychological distress in the chronic phase of recovery', 'persons with traumatic brain injury', 'persons with TBI', 'persons with traumatic brain injury (TBI']","['Acceptance and Commitment Therapy (ACT', 'acceptance and commitment therapy', 'ACT', 'ACT (manualized with adaptations to address TBI-related cognitive impairments) or a single session of needs assessment, brief counseling/education, and referral']","['psychological flexibility and commitment to action (Acceptance and Action Questionnaire-II (AAQ-II) scores', 'psychological distress', 'Psychological distress', 'BSI 18 GSI T scores']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0233794', 'cui_str': 'Memory impairment'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0558005', 'cui_str': 'Assessment of needs'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0045870', 'cui_str': '2-aminoanthraquinone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C3854607', 'cui_str': 'T score'}]",93.0,0.0977811,The ACT group showed significantly greater reduction of psychological distress (Brief Symptom Inventory 18) and demonstrated improvements in psychological flexibility and commitment to action (Acceptance and Action Questionnaire-II (AAQ-II) scores).,"[{'ForeName': 'Angelle M', 'Initials': 'AM', 'LastName': 'Sander', 'Affiliation': 'H. Ben Taub Department of Physical Medicine and Rehabilitation, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Allison N', 'Initials': 'AN', 'LastName': 'Clark', 'Affiliation': 'H. Ben Taub Department of Physical Medicine and Rehabilitation, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Arciniegas', 'Affiliation': 'Brain Injury Research Center, TIRR Memorial Hermann, Houston, TX, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Tran', 'Affiliation': 'Brain Injury Research Center, TIRR Memorial Hermann, Houston, TX, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Leon-Novelo', 'Affiliation': 'Department of Biostatistics and Data Science, School of Public Health , University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Ngan', 'Affiliation': 'Department of Biostatistics and Data Science, School of Public Health , University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Bogaards', 'Affiliation': 'Brain Injury Research Center, TIRR Memorial Hermann, Houston, TX, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sherer', 'Affiliation': 'Brain Injury Research Center, TIRR Memorial Hermann, Houston, TX, USA.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Walser', 'Affiliation': 'National Center for Posttraumatic Stress Disorder, Palo Alto, CA, USA.'}]",Neuropsychological rehabilitation,['10.1080/09602011.2020.1762670']
1347,32408692,The Wildman Programme. A Nature-Based Rehabilitation Programme Enhancing Quality of Life for Men on Long-Term Sick Leave: Study Protocol for a Matched Controlled Study In Denmark.,"Many men have poor mental health and need help to recover. However, designing a rehabilitation intervention that appeals to men is challenging. This study protocol aims to describe the 'Wildman Programme', which will be a nature-based rehabilitation programme for men on long-term sick leave due to health problems such as stress, anxiety, depression, post-cancer and chronic cancer, chronic obstructive pulmonary disease (COPD), cardiovascular disease, or diabetes type II. The programme will be a nature-based rehabilitation initiative combining nature experiences, attention training, body awareness training, and supporting community spirit. The aim of the study will be to examine whether the 'Wildman Programme' can help to increase quality of life and reduce stress among men with health problems compared to treatment as usual. The study will be a matched control study where an intervention group (number of respondents,  N  = 52) participating in a 12-week nature-based intervention will be compared to a control group ( N  = 52) receiving treatment as usual. Outcomes are measured at baseline (T1), post-treatment (T2), and at follow up 6 months post-intervention (T3). The results of this study will be important to state whether the method in the 'Wildman Programme' can be implemented as a rehabilitation offer in the Danish Healthcare System to help men with different health problems.",2020,The aim of the study will be to examine whether the 'Wildman Programme' can help to increase quality of life and reduce stress among men with health problems compared to treatment as usual.,['men with health problems'],['control group ( N  = 52) receiving treatment as usual'],"['quality of life and reduce stress', 'Quality of Life']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",52.0,0.0257458,The aim of the study will be to examine whether the 'Wildman Programme' can help to increase quality of life and reduce stress among men with health problems compared to treatment as usual.,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Høegmark', 'Affiliation': 'Department of Psychology, University of Southern Denmark, 5230 Odense M, Denmark.'}, {'ForeName': 'Tonny Elmose', 'Initials': 'TE', 'LastName': 'Andersen', 'Affiliation': 'Department of Psychology, University of Southern Denmark, 5230 Odense M, Denmark.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Grahn', 'Affiliation': 'Department of Work Science, Business Economics and Environmental Psychology, Swedish University of Agricultural Sciences, SE-230 53 Alnarp, Sweden.'}, {'ForeName': 'Kirsten Kaya', 'Initials': 'KK', 'LastName': 'Roessler', 'Affiliation': 'Department of Psychology, University of Southern Denmark, 5230 Odense M, Denmark.'}]",International journal of environmental research and public health,['10.3390/ijerph17103368']
1348,30982356,Post-hoc  analyses of the edaravone clinical trials Study 16 and Study 19: a step toward more efficient clinical trial designs in amyotrophic lateral sclerosis.,"Objectives:  The edaravone development program established a study design in which a treatment effect slowing functional loss in amyotrophic lateral sclerosis (ALS) could be documented within a 24-week time frame. This report elucidates the strategic enrichment design utilized to create efficiency and precision in the development program.  Methods: Post-hoc  analyses describe learning, sequential iteration, and evolution in study design.  Results:  The first Phase 3 study of edaravone in ALS (Study MCI186-16) included a large proportion (35%) of placebo patients who were minimal progressors. These patients demonstrated high heterogeneity in change in ALSFRS-R score (-4 median with interquartile range [IQR] 7.5) and a modal distribution score of 0, suggesting evidence of minimal change in ALSFRS-R during the study. This level of variability and rate of progression may have made it difficult to detect a prospective treatment effect in the study. A strategic enrichment strategy provided the second Phase 3 study (Study MCI186-19) with the ability to detect a treatment effect. In Study MCI186-19, only 13% of the placebo patients were minimal progressors. Further, these placebo patients demonstrated less heterogeneity and greater functional progression of ALS, thereby providing greater likelihood of detecting a treatment effect. The enrichment strategy may have excluded some rapidly progressing patients, potentially supporting the detection of a treatment effect. As previously published, Study MCI186-19 prospectively documented a 33% reduction in rate of progression of ALS ( p  = 0.0013).  Conclusions:  Strategic choices in the design of Study MCI186-19 reduced the proportion of minimally progressing patients and supported detection of a treatment effect.",2019,"As previously published, Study MCI186-19 prospectively documented a 33% reduction in rate of progression of ALS ( p  = 0.0013).  ","['patients who were minimal progressors', 'amyotrophic lateral sclerosis (ALS', 'amyotrophic lateral sclerosis']",['placebo'],"['rate of progression of ALS', 'ALSFRS-R score', 'minimal progressors', 'functional progression of ALS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0002736', 'cui_str': 'ALS (Amyotrophic Lateral Sclerosis)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.0932916,"As previously published, Study MCI186-19 prospectively documented a 33% reduction in rate of progression of ALS ( p  = 0.0013).  ","[{'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Palumbo', 'Affiliation': 'a Mitsubishi Tanabe Pharma Development America , Jersey City , NJ , USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Hubble', 'Affiliation': 'c Mitsubishi Tanabe Pharma America , Jersey City , NJ , USA , and.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Apple', 'Affiliation': 'c Mitsubishi Tanabe Pharma America , Jersey City , NJ , USA , and.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Takei', 'Affiliation': 'b Mitsubishi Tanabe Pharma Corporation , Tokyo , Japan.'}, {'ForeName': 'Kikumi', 'Initials': 'K', 'LastName': 'Tsuda', 'Affiliation': 'b Mitsubishi Tanabe Pharma Corporation , Tokyo , Japan.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'a Mitsubishi Tanabe Pharma Development America , Jersey City , NJ , USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'd Princeton Pharmatech , Princeton , NJ , USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Agnese', 'Affiliation': 'c Mitsubishi Tanabe Pharma America , Jersey City , NJ , USA , and.'}]",Amyotrophic lateral sclerosis & frontotemporal degeneration,['10.1080/21678421.2019.1599955']
1349,30790446,Index of microvascular resistance to assess the effect of rosuvastatin on microvascular function in women with chest pain and no obstructive coronary artery disease: A double-blind randomized study.,"INTRODUCTION


Many women undergoing coronary angiography for chest pain have no or only minimal coronary artery disease (CAD). However, despite the lack of obstructive CAD, they still have an increased risk of major adverse cardiovascular events. Pleiotropic effects of statins may influence microvascular function, but if statins improve microvascular function in unselected chest pain patients is not well studied. This study assessed microvascular function by using the thermodilution-derived test ""the index of microvascular resistance"" (IMR) with the aim of determining the (i) IMR level in women with chest pain and non-obstructive CAD and if (ii) IMR is modified by high-dose statin treatment in these patients. Additional objectives were to identify the influence of statins on the health status as assessed with generic health questionnaires and on biomarkers of endothelial activation.
MATERIALS AND METHODS


The study was a randomized, double-blind, single-center trial comparing 6 months of rosuvastatin treatment with placebo. In total, 66 women without obstructive CAD were included. Mean age was 52.7 years and 55.5 years in the placebo and rosuvastatin group, respectively. Microvascular function was assessed using the IMR, health status was assessed using the SF-36 and EQ-5D questionnaires, and biochemical values were assessed at baseline and 6 months later.
RESULTS AND CONCLUSIONS


In the placebo group IMR was 14.6 (SD 5.7) at baseline and 14.4 (SD 6.5) at follow-up. In the rosuvastatin group IMR was 16.5 (SD 7.5) at baseline and 14.2 (SD 5.8) at follow-up. IMR did not differ significantly between the two study groups at follow-up controlled for preintervention values. C-reactive protein (CRP) was comparable between the groups at baseline, while at follow-up CRP was significantly lower in the rosuvastatin group compared to placebo [0.6 (±0.5) mg/L vs. 2.6 (±3.0) mg/L; p = 0.002]. Whereas rosuvastatin treatment for 6 months attenuated CRP levels, it did not improve microvascular function as assessed by IMR (Clinical Trials.gov NCT01582165, EUDRACT 2011-002630-39.3tcAZ).",2019,"Whereas rosuvastatin treatment for 6 months attenuated CRP levels, it did not improve microvascular function as assessed by IMR (Clinical Trials.gov NCT 01582165, EUDRACT 2011-002630-39.3tcAZ).","['women with chest pain and non-obstructive CAD and if (ii) IMR', 'Mean age was 52.7 years and 55.5 years in the', 'women with chest pain and no obstructive coronary artery disease', '66 women without obstructive CAD', 'unselected chest pain patients', 'women undergoing coronary angiography for chest pain have no or only minimal coronary artery disease (CAD']","['rosuvastatin', 'placebo', 'placebo and rosuvastatin']","['IMR, health status', 'Microvascular function', 'microvascular function', 'CRP levels', 'SF-36 and EQ-5D questionnaires, and biochemical values', 'C-reactive protein (CRP', 'IMR']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0205304', 'cui_str': 'Non-obstructive (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",66.0,0.239016,"Whereas rosuvastatin treatment for 6 months attenuated CRP levels, it did not improve microvascular function as assessed by IMR (Clinical Trials.gov NCT 01582165, EUDRACT 2011-002630-39.3tcAZ).","[{'ForeName': 'Ole Geir', 'Initials': 'OG', 'LastName': 'Solberg', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Stavem', 'Affiliation': 'Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Asgrimur', 'Initials': 'A', 'LastName': 'Ragnarsson', 'Affiliation': 'Department of Radiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Jan-Otto', 'Initials': 'JO', 'LastName': 'Beitnes', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Skårdal', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Ingebjørg', 'Initials': 'I', 'LastName': 'Seljeflot', 'Affiliation': 'Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Ueland', 'Affiliation': 'Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Aukrust', 'Affiliation': 'Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Aaberge', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28157']
1350,32408795,Measuring outcomes of a peer-led social communication skills intervention for adults with acquired brain injury: A pilot investigation.,"Reduced social competence following severe acquired brain injury (ABI) is well-documented. This pilot study investigated a peer-led group intervention based on the claim that peer models may be a more effective mechanism for behaviour change than clinician-led approaches. Twelve participants with severe ABI were recruited from a post-acute neurorehabilitation setting and randomly assigned to either a peer-led intervention or a staff-led activity group (usual care) (Clinicaltrials.gov: NCT02211339). The groups met twice a week for 8 weeks. A peer was trained separately to facilitate interaction in the intervention group. Training comprised 16 individual sessions over 4 weeks. Group behaviour was measured twice at baseline, after intervention and at maintenance (4 weeks), using the Adapted Measure of Participation in Conversation (MPC) and the Interactional Network Tool (INT), a newly devised measure of group conversational interaction. Outcome measures showed differential sensitivity. The groups did not differ in baseline behaviour. Findings showed a significant improvement in the treated group on the MPC transaction scale post-intervention ( p  = .02). The intervention group showed more balanced interaction post-intervention on the INT and at follow-up. Findings show preliminary evidence of the advantage for peer-led groups. The INT shows promise as a method to detect a change in group communication behaviour.Trial registration: ClinicalTrials.gov identifier: NCT02211339.",2020,Findings showed a significant improvement in the treated group on the MPC transaction scale post-intervention ( p  = .02).,"['Twelve participants with severe ABI were recruited from a post-acute neurorehabilitation setting', 'adults with acquired brain injury']","['peer-led social communication skills intervention', 'Adapted Measure of Participation in Conversation (MPC) and the Interactional Network Tool (INT', 'peer-led intervention or a staff-led activity group (usual care']","['social competence', 'MPC transaction scale', 'differential sensitivity']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0204096', 'cui_str': 'Neurological rehabilitation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",12.0,0.0719811,Findings showed a significant improvement in the treated group on the MPC transaction scale post-intervention ( p  = .02).,"[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Howell', 'Affiliation': 'Division of Psychology and Language Sciences, University College London, London, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Beeke', 'Affiliation': 'Division of Psychology and Language Sciences, University College London, London, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Pring', 'Affiliation': 'Division of Language and Communication Science, City, University of London, London, UK.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Varley', 'Affiliation': 'Division of Psychology and Language Sciences, University College London, London, UK.'}]",Neuropsychological rehabilitation,['10.1080/09602011.2020.1760892']
1351,30544227,In the Eyes of Those Who Were Randomized: Perceptions of Disadvantaged Older Adults in a Tai Chi Trial.,"BACKGROUND AND OBJECTIVES


Older adults living in subsidized housing have typically been excluded from exercise intervention studies. We conducted a qualitative study to explore the perceived physical, psychological, social, and economic factors that influenced participation in and adherence to a year-long Tai Chi intervention within an ongoing cluster-randomized controlled trial (RCT) for older adults living within subsidized housing facilities.
RESEARCH DESIGN AND METHODS


Focus groups were held with participants of the RCT who were allocated to the trial's Tai Chi intervention. Individual phone interviews were conducted with those allocated to Tai Chi who had low adherence or who had withdrawn their participation from the study. Emergent themes were extracted using grounded-theory methods.
RESULTS


In this qualitative study, we enrolled 41 participants who were allocated to the RCT's Tai Chi intervention: 38 completed and 3 withdrew from the study. Average Tai Chi class attendance was 64.3%. Pragmatic factors that led to higher adherence and retention included: locating classes within each facility; providing programs at no cost; and deployment of a skilled research support team. In addition, the use of an accessible, simplified Tai Chi program improved confidence, social support, self-efficacy, and self-reported improvements in physical and psychological well-being.
DISCUSSION AND IMPLICATIONS


Perceived physical, psychological, social benefits, and self-efficacy likely enhance adherence and retention to research-based Tai Chi interventions for older adults. Delivering an on-site, no cost, and supportive program appears critical to overcoming financial and environmental barriers to participation for those living within subsidized housing.",2020,"In addition, the use of an accessible, simplified Tai Chi program improved confidence, social support, self-efficacy, and self-reported improvements in physical and psychological well-being.
","['Individual phone interviews were conducted with those allocated to Tai Chi who had low adherence or who had withdrawn their participation from the study', 'older adults living within subsidized housing facilities', 'older adults', 'Disadvantaged Older Adults', ""41 participants who were allocated to the RCT's Tai Chi intervention: 38 completed and 3 withdrew from the study"", 'Older adults living in subsidized housing']",[],"['confidence, social support, self-efficacy, and self-reported improvements in physical and psychological well-being', 'Average Tai Chi class attendance']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",[],"[{'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0037438'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]",41.0,0.0925067,"In addition, the use of an accessible, simplified Tai Chi program improved confidence, social support, self-efficacy, and self-reported improvements in physical and psychological well-being.
","[{'ForeName': 'On-Yee', 'Initials': 'OY', 'LastName': 'Lo', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife, Boston, Massachusetts.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Conboy', 'Affiliation': 'New England School of Acupuncture, Newton, Massachusetts.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Rukhadze', 'Affiliation': 'New England School of Acupuncture, Newton, Massachusetts.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Georgetti', 'Affiliation': 'New England School of Acupuncture at Massachusetts College of Pharmacy and Health Sciences, Worcester, Massachusetts.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Gagnon', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife, Boston, Massachusetts.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Manor', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife, Boston, Massachusetts.'}, {'ForeName': 'Margie E', 'Initials': 'ME', 'LastName': 'Lachman', 'Affiliation': 'Department of Psychology, Brandeis University, Waltham, Massachusetts.'}, {'ForeName': 'Lewis A', 'Initials': 'LA', 'LastName': 'Lipsitz', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife, Boston, Massachusetts.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}]",The Gerontologist,['10.1093/geront/gny165']
1352,28832927,Innovation in a Learning Health Care System: Veteran-Directed Home- and Community-Based Services.,"A path-breaking example of the interplay between geriatrics and learning healthcare systems is the Veterans Health Administration's (VHA's) planned roll-out of a program for providing participant-directed home- and community-based services to veterans with cognitive and functional limitations. We describe the design of a large-scale, stepped-wedge, cluster-randomized trial of the Veteran-Directed Home- and Community-Based Services (VD-HCBS) program. From March 2017 through December 2019, up to 77 Veterans Affairs Medical Centers will be randomized to times to begin offering VD-HCBS to veterans at risk of nursing home placement. Services will be provided to community-dwelling participants with support from Aging and Disability Network Agencies. The VHA Partnered Evidence-based Policy Resource Center (PEPReC) is coordinating the evaluation, which includes collaboration from operational stakeholders from the VHA and Administration for Community Living and interdisciplinary researchers from the Center of Innovation in Long-Term Services and Supports and the Center for Health Services Research in Primary Care. For older veterans with functional limitations who are eligible for VD-HCBS, we will evaluate health outcomes (hospitalizations, emergency department visits, nursing home admissions, days at home) and healthcare costs associated with VD-HCBS availability. Learning healthcare systems facilitate diffusion of innovation while enabling rigorous evaluation of effects on patient outcomes. The VHA's randomized rollout of VD-HCBS to veterans at risk of nursing home placement is an example of how to achieve these goals simultaneously. PEPReC's experience designing an evaluation with researchers and operations stakeholders may serve as a framework for others seeking to develop rapid, rigorous, large-scale evaluations of delivery system innovations targeted to older adults.",2017,The VHA's randomized rollout of VD-HCBS to veterans at risk of nursing home placement is an example of how to achieve these goals simultaneously.,"['older veterans with functional limitations who are eligible for VD-HCBS', 'From March 2017 through December 2019, up to 77 Veterans Affairs Medical Centers']","['Veteran-Directed Home- and Community-Based Services (VD-HCBS) program', 'VD-HCBS']",[],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],,0.0207107,The VHA's randomized rollout of VD-HCBS to veterans at risk of nursing home placement is an example of how to achieve these goals simultaneously.,"[{'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Garrido', 'Affiliation': 'Partnered Evidence-Based Policy Resource Center, Veterans Affairs Boston Healthcare System, Boston, Massachusetts.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Allman', 'Affiliation': 'Geriatrics and Extended Care Services, Office of Patient Care Services, Veterans Health Administration, Washington, District of Columbia.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Pizer', 'Affiliation': 'Partnered Evidence-Based Policy Resource Center, Veterans Affairs Boston Healthcare System, Boston, Massachusetts.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Rudolph', 'Affiliation': 'Center of Innovation for Long Term Services and Supports, Providence Veterans Affairs Medical Center, Providence, Rhode Island.'}, {'ForeName': 'Kali S', 'Initials': 'KS', 'LastName': 'Thomas', 'Affiliation': 'Center of Innovation for Long Term Services and Supports, Providence Veterans Affairs Medical Center, Providence, Rhode Island.'}, {'ForeName': 'Nina R', 'Initials': 'NR', 'LastName': 'Sperber', 'Affiliation': 'Center for Health Services Research in Primary Care, Health Services Research and Development Service, Durham, North Carolina.'}, {'ForeName': 'Courtney H', 'Initials': 'CH', 'LastName': 'Van Houtven', 'Affiliation': 'Department of Population Health Sciences, School of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Austin B', 'Initials': 'AB', 'LastName': 'Frakt', 'Affiliation': 'Partnered Evidence-Based Policy Resource Center, Veterans Affairs Boston Healthcare System, Boston, Massachusetts.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.15053']
1353,27194545,Impact of Telephone-Based Care Coordination on Use of Cessation Medications Posthospital Discharge: A Randomized Controlled Trial.,"Introduction


Smokers benefit from ongoing cessation support upon leaving the hospital and returning to their home environment. This study examined the impact of telephone-delivered care coordination on utilization of and adherence to cessation pharmacotherapy after hospital discharge.
Methods


Inpatient smokers (n = 606) were randomized to receive counseling with care coordination (CCC) or counseling alone (C) for smoking cessation. Both groups received written materials and telephone-based cessation counseling during hospitalization and postdischarge. CCC recipients received help in selecting, obtaining, and refilling affordable pharmacotherapy prescriptions during and after hospitalization. Study outcomes included self-reported utilization, duration of use, and type of medication during the 3 months postdischarge.
Results


Of the 487 (80%) of participants completing 3-month follow-up, 211 (43.3%) reported using cessation pharmacotherapy postdischarge; this did not differ by study arm (CCC: 44.7%, C: 42.0%, p = .55). Use of pharmacotherapy postdischarge was associated with smoking at least 20 cigarettes/day at baseline (odds ratio [OR]: 1.48; 95% confidence interval [CI]: 1.00-2.19) and receipt of pharmacotherapy during hospitalization (OR: 4.00; 95% CI: 2.39-6.89). Smokers with Medicaid (OR: 2.29; 95% CI: 1.32-4.02) or other insurance (OR: 1.69; 95% CI: 1.01-2.86) were more likely to use pharmacotherapy postdischarge than those with no health care coverage. Less than one in four (23.8% of CCC; 22.2% of C) continued pharmacotherapy beyond 4 weeks.
Conclusions


Supplemental care coordination did not improve use of postdischarge pharmacotherapy beyond that of inpatient treatment and behavioral counseling. Insurance coverage and use of medications during the hospitalization are associated with higher use of evidence-based treatment postdischarge.
Implications


Many hospitalized smokers do not receive the benefits of cessation pharmacotherapy postdischarge and telephone quitline programs often fail to help smokers procure pharmacotherapy. Thus, effective strategies are needed to improve utilization and adherence to evidence-based cessation therapies when smokers leave the hospital. We found that use of postdischarge pharmacotherapy was strongly associated with receipt of pharmacotherapy during the hospitalization and with the availability of insurance to cover the costs of treatment. Additional efforts to coordinate pharmacotherapy services did not improve either utilization or adherence to therapy.",2017,"Insurance coverage and use of medications during the hospitalization are associated with higher use of evidence-based treatment postdischarge.
","['Many hospitalized smokers', 'Cessation Medications Posthospital Discharge', 'Methods\n\n\nInpatient smokers (n = 606']","['telephone-delivered care coordination', 'counseling with care coordination (CCC) or counseling alone (C) for smoking cessation', 'telephone quitline programs', 'CCC', 'Telephone-Based Care Coordination', 'written materials and telephone-based cessation counseling']","['self-reported utilization, duration of use, and type of medication during the 3 months postdischarge', 'cessation pharmacotherapy postdischarge']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]",606.0,0.0451026,"Insurance coverage and use of medications during the hospitalization are associated with higher use of evidence-based treatment postdischarge.
","[{'ForeName': 'Caleb', 'Initials': 'C', 'LastName': 'Tague', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Kimber P', 'Initials': 'KP', 'LastName': 'Richter', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Lisa S', 'Initials': 'LS', 'LastName': 'Cox', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Keighley', 'Affiliation': 'Department of Biostatistics, University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Tresza', 'Initials': 'T', 'LastName': 'Hutcheson', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Sharon A', 'Initials': 'SA', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Ellerbeck', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, KS.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntw138']
1354,32408817,Comparative Significance of Invasive Measures of Microvascular Injury in Acute Myocardial Infarction.,"BACKGROUND


The resistive reserve ratio (RRR) expresses the ratio between basal and hyperemic microvascular resistance. RRR measures the vasodilatory capacity of the microcirculation. We compared RRR, index of microcirculatory resistance (IMR), and coronary flow reserve (CFR) for predicting microvascular obstruction (MVO), myocardial hemorrhage, infarct size, and clinical outcomes, after ST-segment-elevation myocardial infarction.
METHODS


In the T-TIME trial (Trial of Low-Dose Adjunctive Alteplase During Primary PCI), 440 patients with acute ST-segment-elevation myocardial infarction from 11 UK hospitals were prospectively enrolled. In a subset of 144 patients, IMR, CFR, and RRR were measured post-primary percutaneous coronary intervention. MVO extent (% left ventricular mass) was determined by cardiovascular magnetic resonance imaging at 2 to 7 days. Infarct size was determined at 3 months. One-year major adverse cardiac events, heart failure hospitalizations, and all-cause death/heart failure hospitalizations were assessed.
RESULTS


In these 144 patients (mean age, 59±11 years, 80% male), median IMR was 29.5 (interquartile range: 17.0-55.0), CFR was 1.4 (1.1-2.0), and RRR was 1.7 (1.3-2.3). MVO occurred in 41% of patients. IMR>40 was multivariably associated with more MVO (coefficient, 0.53 [95% CI, 0.05-1.02];  P =0.031), myocardial hemorrhage presence (odds ratio [OR], 3.20 [95% CI, 1.25-8.24];  P =0.016), and infarct size (coefficient, 5.05 [95% CI, 0.84-9.26];  P =0.019), independently of CFR≤2.0, RRR≤1.7, myocardial perfusion grade≤1, and Thrombolysis in Myocardial Infarction frame count. RRR was multivariably associated with MVO extent (coefficient, -0.60 [95% CI, -0.97 to -0.23];  P =0.002), myocardial hemorrhage presence (OR, 0.34 [95% CI, 0.15-0.75];  P =0.008), and infarct size (coefficient, -3.41 [95% CI, -6.76 to -0.06];  P =0.046). IMR>40 was associated with heart failure hospitalization (OR, 5.34 [95% CI, 1.80-15.81]  P =0.002), major adverse cardiac events (OR, 4.46 [95% CI, 1.70-11.70]  P =0.002), and all-cause death/ heart failure hospitalization (OR, 4.08 [95% CI, 1.55-10.79]  P =0.005). RRR was associated with heart failure hospitalization (OR, 0.44 [95% CI, 0.19-0.99]  P =0.047). CFR was not associated with infarct characteristics or clinical outcomes.
CONCLUSIONS


In acute ST-segment-elevationl infarction, IMR and RRR, but not CFR, were associated with MVO, myocardial hemorrhage, infarct size, and clinical outcomes. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02257294.",2020,"IMR>40 was associated with heart failure hospitalization (OR, 5.34 [95% CI, 1.80-15.81]  P =0.002), major adverse cardiac events (OR, 4.46 [95% CI, 1.70-11.70]  P =0.002), and all-cause death/ heart failure hospitalization (OR, 4.08 [95% CI, 1.55-10.79]  P =0.005).","['440 patients with acute ST-segment-elevation myocardial infarction from 11 UK hospitals were prospectively enrolled', 'Acute Myocardial Infarction', '144 patients (mean age, 59±11 years, 80% male']",[],"['CFR', 'heart failure hospitalization', 'RRR', 'MVO', 'infarct size', 'Infarct size', 'RRR, index of microcirculatory resistance (IMR), and coronary flow reserve (CFR) for predicting microvascular obstruction (MVO), myocardial hemorrhage, infarct size, and clinical outcomes, after ST-segment-elevation myocardial infarction', 'myocardial hemorrhage presence', 'adverse cardiac events, heart failure hospitalizations, and all-cause death/heart failure hospitalizations', 'MVO, myocardial hemorrhage, infarct size, and clinical outcomes', 'IMR, CFR, and RRR', 'CFR≤2.0, RRR≤1.7, myocardial perfusion grade≤1, and Thrombolysis in Myocardial Infarction frame count', 'IMR>40', 'median IMR', 'major adverse cardiac events']","[{'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],"[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0877077', 'cui_str': 'Myocardial haemorrhage'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",440.0,0.426171,"IMR>40 was associated with heart failure hospitalization (OR, 5.34 [95% CI, 1.80-15.81]  P =0.002), major adverse cardiac events (OR, 4.46 [95% CI, 1.70-11.70]  P =0.002), and all-cause death/ heart failure hospitalization (OR, 4.08 [95% CI, 1.55-10.79]  P =0.005).","[{'ForeName': 'Annette M', 'Initials': 'AM', 'LastName': 'Maznyczka', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.C.P., C.B.).'}, {'ForeName': 'Keith G', 'Initials': 'KG', 'LastName': 'Oldroyd', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.C.P., C.B.).'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Greenwood', 'Affiliation': 'Leeds University and Leeds Teaching Hospitals NHS Trust, United Kingdom (J.P.G.).'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'McCartney', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.C.P., C.B.).'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Cotton', 'Affiliation': 'Wolverhampton University Hospital NHS Trust, United Kingdom (J.C.).'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Lindsay', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.L., M.McE., J.P.R., R.G., K.R., H.E., S.W., A.S., C.B.).'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McEntegart', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.L., M.McE., J.P.R., R.G., K.R., H.E., S.W., A.S., C.B.).'}, {'ForeName': 'J Paul', 'Initials': 'JP', 'LastName': 'Rocchiccioli', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.L., M.McE., J.P.R., R.G., K.R., H.E., S.W., A.S., C.B.).'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Good', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.L., M.McE., J.P.R., R.G., K.R., H.E., S.W., A.S., C.B.).'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Robertson', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.L., M.McE., J.P.R., R.G., K.R., H.E., S.W., A.S., C.B.).'}, {'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'Eteiba', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.L., M.McE., J.P.R., R.G., K.R., H.E., S.W., A.S., C.B.).'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Watkins', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.L., M.McE., J.P.R., R.G., K.R., H.E., S.W., A.S., C.B.).'}, {'ForeName': 'Aadil', 'Initials': 'A', 'LastName': 'Shaukat', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.L., M.McE., J.P.R., R.G., K.R., H.E., S.W., A.S., C.B.).'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Petrie', 'Affiliation': 'University Hospital Monklands, NHS Lanarkshire, United Kingdom (C.J.P.).'}, {'ForeName': 'Aengus', 'Initials': 'A', 'LastName': 'Murphy', 'Affiliation': ''}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.C.P., C.B.).'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.C.P., C.B.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008505']
1355,30562138,Embodied Precision: Intranasal Oxytocin Modulates Multisensory Integration.,"Multisensory integration processes are fundamental to our sense of self as embodied beings. Bodily illusions, such as the rubber hand illusion (RHI) and the size-weight illusion (SWI), allow us to investigate how the brain resolves conflicting multisensory evidence during perceptual inference in relation to different facets of body representation. In the RHI, synchronous tactile stimulation of a participant's hidden hand and a visible rubber hand creates illusory body ownership; in the SWI, the perceived size of the body can modulate the estimated weight of external objects. According to Bayesian models, such illusions arise as an attempt to explain the causes of multisensory perception and may reflect the attenuation of somatosensory precision, which is required to resolve perceptual hypotheses about conflicting multisensory input. Recent hypotheses propose that the precision of sensorimotor representations is determined by modulators of synaptic gain, like dopamine, acetylcholine, and oxytocin. However, these neuromodulatory hypotheses have not been tested in the context of embodied multisensory integration. The present, double-blind, placebo-controlled, crossover study ( n = 41 healthy volunteers) aimed to investigate the effect of intranasal oxytocin (IN-OT) on multisensory integration processes, tested by means of the RHI and the SWI. Results showed that IN-OT enhanced the subjective feeling of ownership in the RHI, only when synchronous tactile stimulation was involved. Furthermore, IN-OT increased an embodied version of the SWI (quantified as estimation error during a weight estimation task). These findings suggest that oxytocin might modulate processes of visuotactile multisensory integration by increasing the precision of top-down signals against bottom-up sensory input.",2019,"Furthermore, IN-OT increased an embodied version of the SWI (quantified as estimation error during a weight estimation task).",['41 healthy volunteers'],"['intranasal oxytocin (IN-OT', 'oxytocin', 'Intranasal Oxytocin', 'placebo']","['Embodied Precision', 'Bodily illusions, such as the rubber hand illusion (RHI) and the size-weight illusion (SWI', 'visuotactile multisensory integration', 'subjective feeling of ownership']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0020903', 'cui_str': 'Illusions'}, {'cui': 'C0035918', 'cui_str': 'Natural Rubber'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0029981', 'cui_str': 'Ownership'}]",41.0,0.0402953,"Furthermore, IN-OT increased an embodied version of the SWI (quantified as estimation error during a weight estimation task).","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Crucianelli', 'Affiliation': 'University College London.'}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Paloyelis', 'Affiliation': ""King's College London.""}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Ricciardi', 'Affiliation': ""St. George's University of London.""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Jenkinson', 'Affiliation': 'University of Hertfordshire.'}, {'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Fotopoulou', 'Affiliation': 'University College London.'}]",Journal of cognitive neuroscience,['10.1162/jocn_a_01366']
1356,30564847,Ultrasound-guided low thoracic paravertebral block versus peritubal infiltration for percutaneous nephrolithotomy: a prospective randomized study.,"The aim of this study was to investigate the efficacy of peritubular infiltration and ultrasound-guided low thoracal paravertebral block in patients undergoing percutaneous nephrolithotomy (PCNL). Sixty patients, American Society of Anesthesiologists I-II, between the ages of 18 and 65 years undergoing PCNL were randomized into three groups. Group peritubal infiltration (Pi, n = 20) received infiltration along the nephrostomy tube 20 ml 0.25% bupivacaine, in 6 and 12 o'clock position. Group paravertebral block (Pv, n = 20) received single-shot paravertebral block with 20 ml 0.25% bupivacaine at the level of T8-T9. Group control (C, n = 20): no intervention is performed. Postoperative opioid consumption and pain scores, opioid-related side effects, and additional analgesic requirement were recorded. The fentanyl consumption in Group Pv was significantly lower in comparison to Group C in all time intervals (p < 0.05). In the comparison of Group Pv and Group Pi, fentanyl consumptions in the postoperative 0-4th hours (100.00 ± 50.65 and 145.00 ± 61.55, respectively), 4-8th hours (50.00 ± 64.88 and 121.25 ± 56.93 respectively), and in the total of 24 h (197.50 ± 133.74 and 368.75 ± 116.66 respectively) were significantly lower in Group Pv (p < 0.05). The dynamic VAS scores analyzed at the 1st and 2nd hours were significantly lower in Group Pv than Group Pi (p < 0.05). Eight patients in Group C, two patients in Group Pi and 1 patient in Group Pv required additional analgesics and the difference was significant (p < 0.05). Paravertebral block achieved more effective analgesia by reducing postoperative opioid consumption and VAS scores comparison to the control and peritubal infiltration groups in patients undergoing percutaneous nephrolithotomy.",2020,The fentanyl consumption in Group Pv was significantly lower in comparison to Group C in all time intervals (p < 0.05).,"['Sixty patients, American Society of Anesthesiologists I-II, between the ages of 18 and 65\xa0years undergoing PCNL', 'patients undergoing percutaneous nephrolithotomy (PCNL']","['peritubular infiltration and ultrasound-guided low thoracal paravertebral block', 'infiltration along the nephrostomy tube 20\xa0ml 0.25% bupivacaine', 'single-shot paravertebral block with 20\xa0ml 0.25% bupivacaine', 'Ultrasound-guided low thoracic paravertebral block versus peritubal infiltration for percutaneous nephrolithotomy', 'percutaneous nephrolithotomy']","['dynamic VAS scores', 'Postoperative opioid consumption and pain scores, opioid-related side effects, and additional analgesic requirement', 'postoperative opioid consumption and VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}]","[{'cui': 'C0456918', 'cui_str': 'Peritubular (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0184149', 'cui_str': 'Nephrostomy tube (physical object)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1444774', 'cui_str': 'Shooting'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}]",,0.0300188,The fentanyl consumption in Group Pv was significantly lower in comparison to Group C in all time intervals (p < 0.05).,"[{'ForeName': 'Ahmet Murat', 'Initials': 'AM', 'LastName': 'Yayik', 'Affiliation': 'Department of Anesthesiology, Regional Training and Research Hospital, Erzurum, Turkey. m_yayik@hotmail.com.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ahiskalioglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Saban Oguz', 'Initials': 'SO', 'LastName': 'Demirdogen', 'Affiliation': 'Department of Urology, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Elif Oral', 'Initials': 'EO', 'LastName': 'Ahiskalioglu', 'Affiliation': 'Department of Anesthesiology, Regional Training and Research Hospital, Erzurum, Turkey.'}, {'ForeName': 'Haci Ahmet', 'Initials': 'HA', 'LastName': 'Alici', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Husnu', 'Initials': 'H', 'LastName': 'Kursad', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}]",Urolithiasis,['10.1007/s00240-018-01106-w']
1357,31148494,Effects of Radial Shockwave Therapy and Orthotics Applied with Physical Training on Motor Function of Children with Spastic Diplegia: A Randomized Trial.,"Aims:  To explore the effects of radial shockwave therapy (rSWT) combined with standard orthotic management (SOM) on spasticity, functional balance, and gait in children with spastic diplegia.  Methods:  Sixty children with diplegia were allocated to group I (rSWT,  n  = 20), group II (SOM,  n  = 20), or group III (rSWT + SOM,  n  = 20). All groups received a physical training program 3 times/week for 3 months. Assessments were completed before and immediately after the intervention and included the Hoffman reflex/Myogenic response ratio of the soleus muscle (H/M ratio), balance, and gait.  Results:  At a significance criterion adjusted to  p  ˂ .006, there were no between-group differences in balance or gait ( p  > .006). The rSWT + SOM group had a greater improvement of H/M ratio compared to rSWT alone ( p  = .001) but not to SOM alone ( p  = .04). Within-group analysis demonstrated significant improvement of all variables for rSWT + SOM ( p  ˂ .006). The H/M ratio and knee midstance angle exhibited clinically meaningful improvement for rSWT alone ( p  ˂ .006). No significant changes were observed in any variable for SOM alone ( p  > .006).  Conclusions:  Radial shockwave and orthotics together, or either of them along with physical training did not differ in improving balance or gait. Their combination was more effective than rSWT alone in reducing spasticity.",2019,The H/M ratio and knee midstance angle exhibited clinically meaningful improvement for rSWT alone ( p  ˂ .006).,"['Children with Spastic Diplegia', 'children with spastic diplegia', 'Sixty children with diplegia']","['Radial shockwave and orthotics together, or either of them along with physical training', 'physical training program', 'Radial Shockwave Therapy and Orthotics Applied with Physical Training', 'rSWT + SOM', 'radial shockwave therapy (rSWT) combined with standard orthotic management (SOM', 'rSWT']","['rSWT + SOM', 'spasticity', 'Motor Function', 'Hoffman reflex/Myogenic response ratio of the soleus muscle (H/M ratio), balance, and gait', 'spasticity, functional balance, and gait', 'H/M ratio', 'balance or gait']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023882', 'cui_str': 'Spastic Diplegia'}, {'cui': 'C0221165', 'cui_str': 'Bilateral paralysis'}]","[{'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0277839', 'cui_str': ""Hoffman's Reflex""}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0242694', 'cui_str': 'Soleus Muscle'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",60.0,0.0149269,The H/M ratio and knee midstance angle exhibited clinically meaningful improvement for rSWT alone ( p  ˂ .006).,"[{'ForeName': 'Ragab K', 'Initials': 'RK', 'LastName': 'Elnaggar', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University , Cairo , Egypt.'}, {'ForeName': 'Amira M', 'Initials': 'AM', 'LastName': 'Abd-Elmonem', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University , Cairo , Egypt.'}]",Physical & occupational therapy in pediatrics,['10.1080/01942638.2019.1597821']
1358,32408862,Comparison of C-MAC D-blade videolaryngoscope and McCoy laryngoscope efficacy for nasotracheal intubation in simulated cervical spinal injury: a prospective randomized comparative study.,"BACKGROUND


Immobilization with cervical spine worsens endotracheal intubation condition. Though various intubation devices have been demonstrated to perform well in oral endotracheal intubation, limited information is available concerning nasotracheal intubation (NTI) in patients with cervical spine immobilization. The present study compared the performance of the C-MAC D-Blade videolaryngoscope with the McCoy laryngoscope for NTI in patients with simulated cervical spine injuries.
METHODS


This was a prospective, randomized, controlled, study done in a tertiary hospital. Ninety-five patients requiring NTI were included in data analysis: McCoy group (group M, n = 47) or C-MAC D-Blade videolaryngoscope group (group C, n = 48). A Philadelphia neck collar was applied before anesthetic induction to immobilize the cervical spine. Single experienced anesthesiologist performed NTI. The primary outcome was duration of intubation divided by three steps: nose to oropharynx; oropharynx into glottic inlet; and glottic inlet to trachea. Secondary outcomes included glottic view as percentage of glottis opening (POGO) score and Cormack-Lehance (CL) grade, modified nasal intubation-difficulty scale (NIDS) rating, hemodynamic changes before and after intubation, and complications.
RESULTS


Total intubation duration was significantly shorter in group C (39.5 ± 11.4 s) compared to group M (48.1 ± 13.9 s). Group C required significantly less time for glottic visualization and endotracheal tube placement in the trachea. More patients in group C had CL grade I and higher POGO scores (P <  0.001, for both measures). No difficulty in NTI (modified NIDS = 0) was more in group C than group M. Hemodynamic changes and incidence of complications were comparable between groups.
CONCLUSION


The C-MAC D-Blade videolaryngoscope is an effective tool for NTI in a simulated difficult airway, which improves glottic visualization and shortens intubation time relative to those with McCoy laryngoscope.
TRIAL REGISTRATION


Clinical Research Information Service of the Korea National Institute of Health, Identification number: KCT 0004535, Registered December 10, 2019, Retrospectively registered, http://cris.nih.go.kr.",2020,"RESULTS


Total intubation duration was significantly shorter in group C (39.5 ± 11.4 s) compared to group M (48.1 ± 13.9 s).","['patients with simulated cervical spine injuries', 'Immobilization with cervical spine worsens endotracheal intubation condition', 'simulated cervical spinal injury', 'patients with cervical spine immobilization', 'Ninety-five patients requiring NTI were included in data analysis']","['nasotracheal intubation', 'C-MAC D-Blade videolaryngoscope with the McCoy laryngoscope for NTI', 'McCoy', 'C-MAC D-Blade videolaryngoscope group', 'C-MAC D-blade videolaryngoscope and McCoy laryngoscope efficacy']","['Hemodynamic changes and incidence of complications', 'duration of intubation divided by three steps', 'time for glottic visualization and endotracheal tube placement', 'CL grade', 'Total intubation duration', 'POGO scores', 'glottic view as percentage of glottis opening (POGO) score and Cormack-Lehance (CL) grade, modified nasal intubation-difficulty scale (NIDS) rating, hemodynamic changes before and after intubation, and complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0432666', 'cui_str': 'Injury of cervical spine'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037937', 'cui_str': 'Spinal injury'}, {'cui': 'C1301792', 'cui_str': 'Cervical spine immobilization'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C2948008', 'cui_str': 'Blade'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.119102,"RESULTS


Total intubation duration was significantly shorter in group C (39.5 ± 11.4 s) compared to group M (48.1 ± 13.9 s).","[{'ForeName': 'Kwon Hui', 'Initials': 'KH', 'LastName': 'Seo', 'Affiliation': 'Department of anesthesiology and pain medicine, Hallym University Sacred Heart Hospital, Hallym University School of Medicine, 22, Gwanpyeong-ro 170 beon-gil, Dong-gu, Anyang-si, Gyeonggi-do, 14068, Republic of Korea.'}, {'ForeName': 'Kyung Mi', 'Initials': 'KM', 'LastName': 'Kim', 'Affiliation': 'Clinical assistant professor, Department of anesthesiology and pain medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea. sumsonyo@gmail.com.'}, {'ForeName': 'Hyunji', 'Initials': 'H', 'LastName': 'John', 'Affiliation': 'Department of anesthesiology and pain medicine, Hallym University Sacred Heart Hospital, Hallym University School of Medicine, 22, Gwanpyeong-ro 170 beon-gil, Dong-gu, Anyang-si, Gyeonggi-do, 14068, Republic of Korea.'}, {'ForeName': 'Joo Hyun', 'Initials': 'JH', 'LastName': 'Jun', 'Affiliation': 'Department of anesthesiology and pain medicine, Kangnam Sacred Heart Hospital, Hallym University School of Medicine, 12, Siheung-daero 187-gil, Yeongdeungpo-gu, Seoul, 07441, Republic of Korea.'}, {'ForeName': 'Minsoo', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'Department of anesthesiology and pain medicine, Hallym University Sacred Heart Hospital, Hallym University School of Medicine, 22, Gwanpyeong-ro 170 beon-gil, Dong-gu, Anyang-si, Gyeonggi-do, 14068, Republic of Korea.'}, {'ForeName': 'Soyoun', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of anesthesiology and pain medicine, Hallym University Sacred Heart Hospital, Hallym University School of Medicine, 22, Gwanpyeong-ro 170 beon-gil, Dong-gu, Anyang-si, Gyeonggi-do, 14068, Republic of Korea.'}]",BMC anesthesiology,['10.1186/s12871-020-01021-x']
1359,21593352,Glutamine reduces postprandial glycemia and augments the glucagon-like peptide-1 response in type 2 diabetes patients.,"Impaired glucagon-like peptide (GLP-1) secretion or response may contribute to ineffective insulin release in type 2 diabetes. The conditionally essential amino acid glutamine stimulates GLP-1 secretion in vitro and in vivo. In a randomized, crossover study, we evaluated the effect of oral glutamine, with or without sitagliptin (SIT), on postprandial glycemia and GLP-1 concentration in 15 type 2 diabetes patients (glycated hemoglobin 6.5 ± 0.6%). Participants ingested a low-fat meal (5% fat) after receiving either water (control), 30 g l-glutamine (Gln-30), 15 g L-glutamine (Gln-15), 100 mg SIT, or 100 mg SIT and 15 g L-glutamine (SIT+Gln-15). Studies were conducted 1-2 wk apart. Blood was collected at baseline and postprandially for 180 min for measurement of circulating glucose, insulin, C-peptide, glucagon, and total and active GLP-1. Gln-30 and SIT+Gln-15 reduced the early (t = 0-60 min) postprandial glycemic response compared with control. All Gln treatments enhanced the postprandial insulin response from t = 60-180 min but had no effect on the C-peptide response compared with control. The postprandial glucagon concentration was increased by Gln-30 and Gln-15 compared with control, but the insulin:glucagon ratio was not affected by any treatment. In contrast to Gln-30, which tended to increase the total GLP-1 AUC, SIT tended to decrease the total GLP-1 AUC relative to control (both P = 0.03). Gln-30 and SIT increased the active GLP-1 AUC compared with control (P = 0.008 and P = 0.01, respectively). In summary, Gln-30 decreased the early postprandial glucose response, enhanced late postprandial insulinemia, and augmented postprandial active GLP-1 responses compared with control. These findings suggest that glutamine may be a novel agent for stimulating GLP-1 concentration and limiting postprandial glycemia in type 2 diabetes.",2011,"Gln-30 and SIT increased the active GLP-1 AUC compared with control (P = 0.008 and P = 0.01, respectively).","['type 2 diabetes patients', '15 type 2 diabetes patients (glycated hemoglobin 6.5 ± 0.6']","['Gln-30 and SIT+Gln-15', 'oral glutamine, with or without sitagliptin (SIT', 'low-fat meal (5% fat) after receiving either water (control), 30 g l-glutamine (Gln-30), 15 g L-glutamine (Gln-15), 100 mg SIT, or 100 mg SIT and 15 g L-glutamine', 'Glutamine', 'glutamine']","['postprandial glycemia', 'total GLP-1', 'postprandial glycemia and GLP-1 concentration', 'Gln-30 and SIT increased the active GLP-1 AUC', 'postprandial glycemic response', 'insulin:glucagon ratio', 'total GLP-1 AUC, SIT', 'postprandial glucagon concentration', 'C-peptide response', 'postprandial insulin response', 'early postprandial glucose response, enhanced late postprandial insulinemia, and augmented postprandial active GLP-1 responses', 'circulating glucose, insulin, C-peptide, glucagon, and total and active GLP-1']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}]",,0.0300533,"Gln-30 and SIT increased the active GLP-1 AUC compared with control (P = 0.008 and P = 0.01, respectively).","[{'ForeName': 'Dorit', 'Initials': 'D', 'LastName': 'Samocha-Bonet', 'Affiliation': 'Diabetes and Obesity Research Program, Garvan Institute of Medical Research, Sydney 2010, Australia.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Emma-Leigh', 'Initials': 'EL', 'LastName': 'Synnott', 'Affiliation': ''}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Piyaratna', 'Affiliation': ''}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Douglas', 'Affiliation': ''}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Gribble', 'Affiliation': ''}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': ''}, {'ForeName': 'Donald J', 'Initials': 'DJ', 'LastName': 'Chisholm', 'Affiliation': ''}, {'ForeName': 'Jerry R', 'Initials': 'JR', 'LastName': 'Greenfield', 'Affiliation': ''}]",The Journal of nutrition,['10.3945/jn.111.139824']
1360,30558978,Neurocognition as a predictor of transition to psychotic disorder and functional outcomes in ultra-high risk participants: Findings from the NEURAPRO randomized clinical trial.,"BACKGROUND


Neurocognitive impairments experienced by individuals at ultra-high risk (UHR) for psychosis are potential predictors of outcome within this population, however there is inconsistency regarding the specific neurocognitive domains implicated. This study aimed to examine whether baseline neurocognition predicted transition to psychosis, or functional outcomes, at medium-term (mean = 3.4 years) follow-up, while controlling for other clinical/treatment variables associated with transition to psychosis.
METHOD


Analysis of data collected as part of a multi-centre RCT of omega-3 fatty acids and cognitive-behavioural case management (NEURAPRO) for UHR individuals was conducted on the 294 participants (134 males, 160 females) who completed neurocognitive assessment (Brief Assessment of Cognition for Schizophrenia) at baseline. Transition to psychosis was determined using the Comprehensive Assessment of At-Risk Mental States (CAARMS), and functioning was measured with the Global Functioning: Social and Role Scales.
RESULTS


Mean baseline z-scores indicated that UHR participants performed a quarter to half a standard deviation below normative means in all domains (range mean z = -0.24 to -0.47), except for executive functioning (mean z = 0.16). After adjusting for covariates, poorer Executive (p = .010) and Motor (p = .030) functions were predictive of transition to psychosis. Processing Speed and Verbal Fluency were significant predictors of role functioning at 12 months (p = .004), and social functioning at medium-term follow-up (p = .015), respectively.
CONCLUSIONS


Neurocognitive abilities are independent predictors of both transition to psychosis and functional outcomes within the UHR population. Further research is needed to determine the best combination of risk variables in UHR individuals for prediction of psychosis transition, functioning and other psychopathology outcomes.",2019,"After adjusting for covariates, poorer Executive (p = .010) and Motor (p = .030) functions were predictive of transition to psychosis.","['ultra-high risk participants', 'Analysis of data collected as part of a multi-centre RCT of omega-3 fatty acids and cognitive-behavioural case management (NEURAPRO) for UHR individuals was conducted on the 294 participants (134 males, 160 females) who completed neurocognitive assessment (Brief Assessment of Cognition for Schizophrenia) at baseline']",[],"['Processing Speed and Verbal Fluency', 'z-scores', 'Comprehensive Assessment of At-Risk Mental States (CAARMS), and functioning', 'social functioning', 'executive functioning']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0085971', 'cui_str': 'Case Management'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}]",[],"[{'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C4305073', 'cui_str': 'Comprehensive Assessment of At-risk Mental States (assessment scale)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",294.0,0.10395,"After adjusting for covariates, poorer Executive (p = .010) and Motor (p = .030) functions were predictive of transition to psychosis.","[{'ForeName': 'Luke K', 'Initials': 'LK', 'LastName': 'Bolt', 'Affiliation': 'Department of Psychology and Counselling, La Trobe University, Bundoora, Australia.'}, {'ForeName': 'G Paul', 'Initials': 'GP', 'LastName': 'Amminger', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, Parkville, Australia; The Centre for Youth Mental Health, The University of Melbourne, Melbourne, Australia; Department of Child and Adolescent Psychiatry, Medical University Vienna, Vienna, Austria. Electronic address: paul.amminger@orygen.org.au.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Farhall', 'Affiliation': 'Department of Psychology and Counselling, La Trobe University, Bundoora, Australia. Electronic address: j.farhall@latrobe.edu.au.'}, {'ForeName': 'Patrick D', 'Initials': 'PD', 'LastName': 'McGorry', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, Parkville, Australia; The Centre for Youth Mental Health, The University of Melbourne, Melbourne, Australia. Electronic address: pat.mcgorry@orygen.org.au.'}, {'ForeName': 'Barnaby', 'Initials': 'B', 'LastName': 'Nelson', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, Parkville, Australia; The Centre for Youth Mental Health, The University of Melbourne, Melbourne, Australia. Electronic address: barnaby.nelson@orygen.org.au.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Markulev', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, Parkville, Australia; The Centre for Youth Mental Health, The University of Melbourne, Melbourne, Australia. Electronic address: connie.markulev@orygen.org.au.'}, {'ForeName': 'Hok Pan', 'Initials': 'HP', 'LastName': 'Yuen', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, Parkville, Australia; The Centre for Youth Mental Health, The University of Melbourne, Melbourne, Australia. Electronic address: hokpan.yuen@orygen.org.au.'}, {'ForeName': 'Miriam R', 'Initials': 'MR', 'LastName': 'Schäfer', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, Parkville, Australia; Department of Child and Adolescent Psychiatry, Medical University Vienna, Vienna, Austria.'}, {'ForeName': 'Nilufar', 'Initials': 'N', 'LastName': 'Mossaheb', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Medical University Vienna, Vienna, Austria. Electronic address: nilufar.mossaheb@meduniwien.ac.at.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Schlögelhofer', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Medical University Vienna, Vienna, Austria. Electronic address: monika.schloegelhofer@meduniwien.ac.at.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Smesny', 'Affiliation': 'Department of Psychiatry, University Hospital Jena, Jena, Germany. Electronic address: stefan.smesny@med.uni-jena.de.'}, {'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Hickie', 'Affiliation': 'Brain and Mind Centre, University of Sydney, Sydney, Australia. Electronic address: Ian.hickie@sydney.edu.au.'}, {'ForeName': 'Gregor Emanuel', 'Initials': 'GE', 'LastName': 'Berger', 'Affiliation': 'Child and Adolescent Psychiatric Service of the Canton of Zurich, Zurich, Switzerland. Electronic address: gregor.berger@puk.zh.ch.'}, {'ForeName': 'Eric Y H', 'Initials': 'EYH', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, University of Hong Kong, Hong Kong. Electronic address: eyhchen@hkusua.hku.hk.'}, {'ForeName': 'Lieuwe', 'Initials': 'L', 'LastName': 'de Haan', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Centers, the Netherlands. Electronic address: l.dehaan@amc.uva.nl.'}, {'ForeName': 'Dorien H', 'Initials': 'DH', 'LastName': 'Nieman', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Centers, the Netherlands. Electronic address: d.h.nieman@amc.uva.nl.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Nordentoft', 'Affiliation': 'Psychiatric Centre Bispebjerg, Copenhagen, Denmark. Electronic address: merete.nordentoft@regionh.dk.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Riecher-Rössler', 'Affiliation': 'Psychiatric University Clinics Basel, Basel, Switzerland. Electronic address: anita.riecher@upkbs.ch.'}, {'ForeName': 'Swapna', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Institute of Mental Health, Singapore, Singapore. Electronic address: swapna_verma@imh.com.sg.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Thompson', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, Parkville, Australia; Division of Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, England, United Kingdom of Great Britain and Northern Ireland; North Warwickshire Early Intervention in Psychosis Service, Coventry and Warwickshire National Health Service Partnership Trust, Coventry, England, United Kingdom of Great Britain and Northern Ireland. Electronic address: andrew.d.thompson@warwick.ac.uk.'}, {'ForeName': 'Alison Ruth', 'Initials': 'AR', 'LastName': 'Yung', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, Parkville, Australia; Division of Psychology and Mental Health, University of Manchester, Manchester, United Kingdom of Great Britain and Northern Ireland; Greater Manchester Mental Health NHS Foundation Trust, Manchester, United Kingdom of Great Britain and Northern Ireland. Electronic address: alison.yung@manchester.ac.uk.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Allott', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, Parkville, Australia; The Centre for Youth Mental Health, The University of Melbourne, Melbourne, Australia. Electronic address: kelly.allott@orygen.org.au.'}]",Schizophrenia research,['10.1016/j.schres.2018.12.013']
1361,31335572,"A Randomized, Double-blind, Active-controlled Phase III Trial of a Cell Culture-derived Quadrivalent Inactivated Influenza Vaccine in Healthy South Korean Children and Adolescents 6 Months to 18 Years of Age.","BACKGROUND


Cell culture-derived influenza vaccines have several important advantages over egg-based influenza vaccines. The quadrivalent influenza vaccine may offer broader protection against seasonal influenza than trivalent influenza vaccine by containing 1 more B strain. The purpose of this study was to evaluate the immunogenicity and safety of NBP607-QIV, a novel cell culture-derived inactivated quadrivalent influenza vaccine (cIIV4), in children and adolescents.
METHODS


This phase III, randomized, double-blind, multicenter trial in children/adolescents (6 mo to 18 yr) was conducted in South Korea during 2014-2015 season. Subjects were randomized 4:1 to receive either NBP607-QIV or control inactivated trivalent influenza vaccine. Hemagglutination inhibition antibody titers were assessed in prevaccination and 28 days postvaccination sera. Safety data were collected for up to 6 months postvaccination.
RESULTS


A total of 454 participants completed the study. Three-hundred sixty-six subjects received cIIV4 and 88 subjects received inactivated trivalent influenza vaccine. Overall, NBP607-QIV met the immunogenicity criteria of Committee for Medicinal Products for Human Use for each of the 4 strains. Between the NBP607-QIV and control groups, immunogenicity endpoints were comparable. Participants younger than 3 years of age had lower immunologic responses to 2 influenza B strains in both NBP607-QIV and control group. No deaths, vaccine-related serious adverse events (AEs) or withdrawals because of AEs were reported. The solicited AEs reported were generally of mild intensity.
CONCLUSIONS


NBP607-QIV, a novel cIIV4, showed good immunogenicity to all 4 influenza strains and had tolerable safety profiles in children and adolescents. Moreover, NBP607-QIV was more immunogenic against influenza B compared with the control, an egg-based subunit vaccine.",2019,Participants younger than 3 years of age had lower immunologic responses to 2 influenza B strains in both NBP607-QIV and control group.,"['children/adolescents (6 mo to 18 yr) was conducted in South Korea during 2014-2015 season', '454 participants completed the study', 'Three-hundred sixty-six subjects received cIIV4 and 88 subjects received', 'Participants younger than 3 years of age had lower immunologic responses to 2 influenza B strains in both NBP607-QIV and control group', 'Healthy South Korean Children and Adolescents 6 Months to 18 Years of Age', 'children and adolescents']","['NBP607-QIV', 'inactivated trivalent influenza vaccine', 'NBP607-QIV, a novel cell culture-derived inactivated quadrivalent influenza vaccine (cIIV4', 'NBP607-QIV or control inactivated trivalent influenza vaccine', 'Cell Culture-derived Quadrivalent Inactivated Influenza Vaccine']","['No deaths, vaccine-related serious adverse events (AEs) or withdrawals because of AEs', 'immunogenicity and safety', 'Hemagglutination inhibition antibody titers', 'immunogenicity endpoints']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C4517782', 'cui_str': '454 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0770694'}, {'cui': 'C0007585', 'cui_str': 'Cell Culture Techniques'}, {'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}]",366.0,0.337309,Participants younger than 3 years of age had lower immunologic responses to 2 influenza B strains in both NBP607-QIV and control group.,"[{'ForeName': 'Byung Wook', 'Initials': 'BW', 'LastName': 'Eun', 'Affiliation': 'From the Department of Pediatrics, Eulji University Eulji General Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Taek Jin', 'Initials': 'TJ', 'LastName': 'Lee', 'Affiliation': 'Department of Pediatrics, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea.'}, {'ForeName': 'Jina', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Pediatrics, Asan Medical Center, University of Ulsan College of Medicine.'}, {'ForeName': 'Ki Hwan', 'Initials': 'KH', 'LastName': 'Kim', 'Affiliation': ""Department of Pediatrics, Severance Children's Hospital, Yonsei University College of Medicine.""}, {'ForeName': 'Dong Ho', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Pediatrics, Korea Cancer Center Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Dae Sun', 'Initials': 'DS', 'LastName': 'Jo', 'Affiliation': ""Department of Pediatrics, Chonbuk National University Children's Hospital, Chonbuk National University Medical School, Jeonju, Republic of Korea.""}, {'ForeName': 'Sun Hee', 'Initials': 'SH', 'LastName': 'Shin', 'Affiliation': 'Department of Pediatrics, Dongtan Sacred Heart Hospital.'}, {'ForeName': 'Hun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'SK Bioscience, Seongnam.'}, {'ForeName': 'Kyung-Ho', 'Initials': 'KH', 'LastName': 'Kim', 'Affiliation': 'SK Bioscience, Seongnam.'}, {'ForeName': 'Yun-Kyung', 'Initials': 'YK', 'LastName': 'Kim', 'Affiliation': 'Department of Pediatrics, Korea University Ansan Hospital, Gyeonggi-do, Republic of Korea.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002406']
1362,30412909,Feasibility and acceptability of Indigenous Counselling and Nicotine (ICAN) QUIT in Pregnancy multicomponent implementation intervention and study design for Australian Indigenous pregnant women: A pilot cluster randomised step-wedge trial.,"BACKGROUND


Many health providers (HPs) lack knowledge, confidence, optimism and skills in addressing smoking with pregnant women. This study aimed to explore the feasibility and acceptability of a) a co-designed multi-component intervention for HPs at Aboriginal Medical Services (AMSs) in culturally-targeted pregnancy-specific smoking cessation care and b) the study design.
METHODS


Using a randomised step-wedge cluster design, the Indigenous Counselling And Nicotine (ICAN) QUIT in Pregnancy Trial was evaluated across six AMSs in three Australian states. HPs were provided educational resource packages including live interactive webinars, treatment manuals, patient resources, carbon monoxide (CO) meters, and oral Nicotine Replacement Therapy (NRT). Feasibility was assessed through recruitment and retention rates of both pregnant women (12-weeks) and HPs (end of study) as well as the potential to improve women's quit rates. Qualitative interviews with staff post-trial explored acceptability of the intervention and study, based on capability, opportunity and motivation from the Behaviour Change Wheel.
RESULTS


Pregnant women (n = 22; 47% (95% CI: 32%, 63%) eligible) and HPs (n = 50; 54% (95% CI: 44%, 64%) eligible) were recruited over 6 months with retention rates of 77% (95% CI: 57%, 90%) and 40% (95% CI: 28%, 54%) respectively. Self-reported 12-week 7-day point-prevalence abstinence was 13.6% (n = 3) and validated abstinent with CO readings ≤6 ppm. Staff interviewed regarding intervention implementation highlighted the importance of provision and use of resources, including training materials, patient resources, CO meters and oral NRT. Resources helped increase capability and opportunity, restructure the environment, and provided social comparison and modelling. Staff were motivated by greater engagement with pregnant women and seeing the women's reductions in CO readings. Having the intervention at the AMSs improved organisational capacity to engage with pregnant women. Staff reported changes to their routine practice that were potentially sustainable. Recommendations for improvement to the implementation of the intervention and research included reducing training length and the tasks related to conducting the study.
CONCLUSION


ICAN QUIT in Pregnancy was a pilot study with the ability to enrol Indigenous women. It was feasible to implement and acceptable to most staff of the AMSs in three states, with modifications recommended. Smoking in pregnancy is a key challenge for Indigenous health. The intervention needs to be evaluated through a methodologically rigorous fully-powered study to determine the efficacy of outcomes for women.
TRIAL REGISTRATION


Australian and New Zealand Clinical Trials Registry, ACTRN12616001603404. Registered 21 November 2016 - retrospectively registered, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371778.",2019,"RESULTS


Pregnant women (n = 22; 47% (95% CI: 32%, 63%) eligible) and HPs (n = 50; 54% (95% CI: 44%, 64%) eligible) were recruited over 6 months with retention rates of 77% (95% CI: 57%, 90%) and 40% (95% CI: 28%, 54%) respectively.","['Australian Indigenous pregnant women', 'pregnant women', 'Registered 21 November 2016 - retrospectively registered, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371778', 'enrol Indigenous women']","['co-designed multi-component intervention', 'Indigenous Counselling And Nicotine (ICAN) QUIT', 'carbon monoxide (CO) meters, and oral Nicotine Replacement Therapy (NRT', 'ICAN QUIT', 'Indigenous Counselling and Nicotine (ICAN) QUIT']","['CO readings', 'organisational capacity']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}]",[],,0.112595,"RESULTS


Pregnant women (n = 22; 47% (95% CI: 32%, 63%) eligible) and HPs (n = 50; 54% (95% CI: 44%, 64%) eligible) were recruited over 6 months with retention rates of 77% (95% CI: 57%, 90%) and 40% (95% CI: 28%, 54%) respectively.","[{'ForeName': 'Gillian S', 'Initials': 'GS', 'LastName': 'Gould', 'Affiliation': 'University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia; Hunter Medical Research Institute, New Lambton Heights, New South Wales 2305, Australia. Electronic address: gillian.gould@newcastle.edu.au.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Bovill', 'Affiliation': 'University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia. Electronic address: michelle.bovill@newcastle.edu.au.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Pollock', 'Affiliation': 'University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia. Electronic address: lauren.pollock@uon.edu.au.'}, {'ForeName': 'Billie', 'Initials': 'B', 'LastName': 'Bonevski', 'Affiliation': 'University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia. Electronic address: billie.bonevski@newcastle.edu.au.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Gruppetta', 'Affiliation': 'University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia. Electronic address: maree.gruppetta@newcastle.edu.au.'}, {'ForeName': 'Lou', 'Initials': 'L', 'LastName': 'Atkins', 'Affiliation': 'University College London, 1-19 Torrington Place, London WC1E 7HB, United Kingdom. Electronic address: l.atkins@ucl.ac.uk.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Carson-Chahhoud', 'Affiliation': 'School of Health Sciences, University of South Australia, Adelaide 5001, South Australia, Australia. Electronic address: Kristin.Carson-Chahhoud@unisa.edu.au.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Boydell', 'Affiliation': 'Black Dog Institute, University of New South Wales, Randwick, New South Wales 2031, Australia. Electronic address: k.boydell@blackdog.org.au.'}, {'ForeName': 'Gabrielle R', 'Initials': 'GR', 'LastName': 'Gribbin', 'Affiliation': 'University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia. Electronic address: gabrielle.gribbin@newcastle.edu.au.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Oldmeadow', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, New South Wales 2305, Australia. Electronic address: Christopher.Oldmeadow@hmri.org.au.'}, {'ForeName': 'Alix', 'Initials': 'A', 'LastName': 'Hall', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, New South Wales 2305, Australia. Electronic address: Alix.Hall@hmri.org.au.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Bar-Zeev', 'Affiliation': 'University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia. Electronic address: Yael.BarZeev@uon.edu.au.'}]",Addictive behaviors,['10.1016/j.addbeh.2018.10.036']
1363,30315625,Nifedipine alone or combined with sildenafil citrate for management of threatened preterm labour: a randomised trial.,"OBJECTIVE


To study the tocolytic action of nifedipine combined with sildenafil citrate (SC) and if the combination is superior to nifedipine alone in inhibiting threatened preterm labour (PTL).
DESIGN


Prospective randomised study.
SETTING


An Egyptian university hospital.
POPULATION


Women with threatened PTL who received either nifedipine with SC or nifedipine alone.
METHODS


Patients were randomly allocated to receive either (1) nifedipine 20 mg orally (stat dose), followed by 10 mg orally every 6-8 hours at the same time as vaginal administration of SC (25 mg at 8-hourly intervals) or (2) nifedipine alone. Medications were continued for 48-72 hours.
MAIN OUTCOME MEASURES


The percentage of women who remained undelivered during hospitalisation.
RESULTS


From January 2015 to November 2016, 239 women were randomised. The baseline characteristics of participants were similar. Nifedipine combined with SC was associated with more women remaining undelivered (81.8 versus 68.6%; P = 0.018) during hospitalisation. Regarding secondary outcomes, the addition of SC was also associated with fewer deliveries within 7 days of admission (9.1 versus 20.3%; P = 0.014), prolonged latency (29 versus 7 days; P = 0.002), fewer admissions to neonatal intensive care units (31.4 versus 44.1%; P = 0.043), fewer very preterm deliveries (from 28 to <32 weeks, 20.7 versus 38.1%; P = 0.043), and increased neonatal birthweight (1900 versus 1500 g; P = 0.018).
CONCLUSIONS


Vaginal SC combined with nifedipine is an effective option for tocolytic therapy during threatened PTL.
TWEETABLE ABSTRACT


Vaginal SC enhances the tocolytic effect of nifedipine.",2019,Nifedipine combined with SC was associated with more women remaining undelivered (81.8 versus 68.6%; P = 0.018) during hospitalisation.,"['threatened preterm labour', 'Patients', 'An Egyptian university hospital', 'From January 2015 to November 2016, 239 women were randomised', 'Women with threatened PTL who received either']","['Nifedipine alone or combined with sildenafil citrate', 'nifedipine 20', 'nifedipine', 'nifedipine combined with sildenafil citrate (SC', 'nifedipine alone', 'nifedipine with SC or nifedipine alone', 'Nifedipine']","['fewer deliveries within 7\xa0days of admission', 'preterm deliveries', 'tocolytic effect', 'neonatal birthweight', 'admissions to neonatal intensive care units', 'percentage of women who remained undelivered during hospitalisation', 'prolonged latency']","[{'cui': 'C0022876', 'cui_str': 'Preterm Labor'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0337801', 'cui_str': 'Egyptians (ethnic group)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}]","[{'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C3179497', 'cui_str': 'Tocolytic Effect'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}]",239.0,0.33793,Nifedipine combined with SC was associated with more women remaining undelivered (81.8 versus 68.6%; P = 0.018) during hospitalisation.,"[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Maher', 'Affiliation': 'Faculty of Medicine, Menoufia University, Shebin-Elkom, Egypt.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Sayyed', 'Affiliation': 'Faculty of Medicine, Menoufia University, Shebin-Elkom, Egypt.'}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'El-Khadry', 'Affiliation': 'Department of Epidemiology and Biostatistics, National Liver Institute, Menoufia University, Shebin-Elkom, Egypt.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.15503']
1364,30272231,Pharmacokinetics of dolutegravir with and without darunavir/cobicistat in healthy volunteers.,"Background


Dolutegravir combined with darunavir/cobicistat is a promising NRTI-sparing and/or salvage strategy for the treatment of HIV-1 infection.
Methods


This Phase I, open-label, 57 day, crossover, pharmacokinetic (PK) study, enrolled healthy volunteers aged 18-65 years, who were randomized to one of two groups. Group 1 received dolutegravir (50 mg) once daily for 14 days followed by a 7 day washout, then a 14 day dolutegravir/darunavir/cobicistat (DTG/DRV/COBI) once-daily co-administration period followed by a 7 day washout and finally a 14 day period of darunavir/cobicistat (800/150 mg) once daily. Group 2 followed the same sequence starting with darunavir/cobicistat and concluding with dolutegravir. Each group underwent intensive PK sampling over 24 h on day 14 of each drug period and DTG/DRV/COBI concentrations were measured using validated LC-MS/MS methods.
Results


Twenty participants completed all PK phases. Thirteen were female and median age and BMI were 33.5 years and 27 kg/m2. Dolutegravir geometric mean ratios (GMR, DTG/DRV/COBI versus dolutegravir alone) and 90% CI for Cmax, AUC0-24 and C24 were 1.01 (0.92-1.11), 0.95 (0.87-1.04) and 0.9 (0.8-1.0), respectively. Darunavir GMR (DRV/COBI/DTG versus darunavir/cobicistat alone) and 90% CI for Cmax, AUC0-24 and C24 were 0.90 (0.83-0.98), 0.93 (0.86-1.00) and 0.93 (0.78-1.11), respectively. No grade 3 or 4 adverse events or laboratory abnormalities were observed.
Conclusions


Concentrations of dolutegravir and darunavir, when boosted with cobicistat, decreased by <10% during co-administration, suggesting this combination can be prescribed safely in the treatment of HIV-1, with no adjustment to current guideline-recommended dosages.",2019,"No grade 3 or 4 adverse events or laboratory abnormalities were observed.
","['Thirteen were female and median age and BMI were 33.5\u2009years and 27\u2009kg/m2', 'healthy volunteers', 'enrolled healthy volunteers aged 18-65\u2009years']","['dolutegravir with and without darunavir/cobicistat', '\n\n\nDolutegravir combined with darunavir/cobicistat', 'darunavir/cobicistat and concluding with dolutegravir', 'intensive PK sampling', 'dolutegravir']","['Darunavir GMR', 'Dolutegravir geometric mean ratios (GMR, DTG/DRV/COBI versus dolutegravir alone) and 90% CI for Cmax, AUC0-24 and C24', 'grade 3 or 4 adverse events or laboratory abnormalities']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C3177235', 'cui_str': 'cobicistat'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]",20.0,0.0941133,"No grade 3 or 4 adverse events or laboratory abnormalities were observed.
","[{'ForeName': 'Emilie R', 'Initials': 'ER', 'LastName': 'Elliot', 'Affiliation': ""St Stephen's Clinical Research, Chelsea and Westminster Hospital, 369 Fulham Road, London, UK.""}, {'ForeName': 'Maddalena', 'Initials': 'M', 'LastName': 'Cerrone', 'Affiliation': ""St Stephen's Clinical Research, Chelsea and Westminster Hospital, 369 Fulham Road, London, UK.""}, {'ForeName': 'Elizabeth', 'Initials': '', 'LastName': 'Challenger', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Else', 'Affiliation': 'Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Alieu', 'Initials': 'A', 'LastName': 'Amara', 'Affiliation': 'Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Bisdomini', 'Affiliation': ""St Stephen's Clinical Research, Chelsea and Westminster Hospital, 369 Fulham Road, London, UK.""}, {'ForeName': 'Saye', 'Initials': 'S', 'LastName': 'Khoo', 'Affiliation': 'Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Owen', 'Affiliation': 'Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Boffito', 'Affiliation': ""St Stephen's Clinical Research, Chelsea and Westminster Hospital, 369 Fulham Road, London, UK.""}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dky384']
1365,30256671,Effect of intensive blood pressure lowering on cardiovascular outcomes based on cardiovascular risk: A secondary analysis of the SPRINT trial.,"BACKGROUND


It is not clear whether risk stratification can help choose the most favourable systolic blood pressure target for primary prevention of cardiovascular events.
DESIGN


A secondary analysis of Systolic Blood Pressure Intervention Trial (SPRINT).
METHODS


To perform a secondary analysis, we obtained the data from SPRINT from the National Heart, Lung, and Blood Institute data repository centre. In SPRINT, an open-label trial, participants without diabetes with systolic blood pressure of ≥130 mmHg were randomly assigned to intensive and standard treatment groups with systolic blood pressure targets of <120 and <140 mmHg, respectively. The primary composite outcome was myocardial infarction and other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes. Here, we have analysed data from participants without cardiovascular disease and chronic kidney disease aged under 75 years categorised based on the baseline 10-year Framingham risk score (<10% (low risk); ≥10% and <15% (intermediate risk); ≥15% (high risk)).
RESULTS


A total of 4298 patients were included in the analysis. With intensive treatment, there was a significant reduction in the primary outcome events in patients at high risk (0.86% per year vs. 1.81% per year; hazard ratio (HR) 0.51; 95% confidence interval (CI) 0.31 to 0.85; P = 0.010), and at intermediate risk (0.60% per year vs. 1.46% per year; HR 0.37; 95% CI 0.17 to 0.82; P = 0.014) but not for those at low risk (0.75% per year vs. 0.57% per year; HR 1.14; 95% CI 0.55 to 2.38; P = 0.714).
CONCLUSIONS


Intensive systolic blood pressure reduction is beneficial for primary prevention of cardiovascular morbidity and mortality in patients without diabetes with more than low cardiac risk (above 10%).",2019,"With intensive treatment, there was a significant reduction in the primary outcome events in patients at high risk (0.86% per year vs. 1.81% per year; hazard ratio (HR) 0.51; 95% confidence interval (CI) 0.31 to 0.85; P = 0.010), and at intermediate risk (0.60% per year vs. 1.46% per year; HR 0.37; 95% CI 0.17 to 0.82; P = 0.014) but not for those at low risk (0.75% per year vs. 0.57% per year; HR 1.14; 95% CI 0.55 to 2.38; P = 0.714).
","['patients without diabetes with more than low cardiac risk (above 10', 'participants without cardiovascular disease and chronic kidney disease aged under 75 years categorised based on the baseline 10-year Framingham risk score (<10% (low risk); ≥10% and <15% (intermediate risk); ≥15% (high risk', 'A total of 4298 patients were included in the analysis', 'participants without diabetes with systolic blood pressure of ≥130 mmHg']","['intensive blood pressure lowering', 'Intensive systolic blood pressure reduction']","['myocardial infarction and other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes', 'cardiovascular risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",4298.0,0.359369,"With intensive treatment, there was a significant reduction in the primary outcome events in patients at high risk (0.86% per year vs. 1.81% per year; hazard ratio (HR) 0.51; 95% confidence interval (CI) 0.31 to 0.85; P = 0.010), and at intermediate risk (0.60% per year vs. 1.46% per year; HR 0.37; 95% CI 0.17 to 0.82; P = 0.014) but not for those at low risk (0.75% per year vs. 0.57% per year; HR 1.14; 95% CI 0.55 to 2.38; P = 0.714).
","[{'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Attar', 'Affiliation': '1 Cardiovascular Research Center, Shiraz University of Medical Sciences, Iran.'}, {'ForeName': 'Mehrab', 'Initials': 'M', 'LastName': 'Sayadi', 'Affiliation': '1 Cardiovascular Research Center, Shiraz University of Medical Sciences, Iran.'}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Jannati', 'Affiliation': '3 Department of Cardiovascular Surgery, Shiraz University of Medical Sciences, Iran.'}]",European journal of preventive cardiology,['10.1177/2047487318800741']
1366,32409106,Safety Analysis of Five Randomized Controlled Studies of Daratumumab in Patients With Multiple Myeloma.,"BACKGROUND


Multiple studies have demonstrated the efficacy and safety of daratumumab for relapsed/refractory multiple myeloma (MM) and primary treatment for transplant-eligible and -ineligible patients.
MATERIALS AND METHODS


We conducted an integrated safety analysis to characterize the frequency, severity, natural history, and outcomes of adverse events (AEs) with daratumumab versus comparators. Data were pooled from 5 completed phase III randomized controlled studies that had included 1798 daratumumab-treated and 1797 comparator-treated patients with MM as a first line in both transplant-eligible and transplant-ineligible patients and for relapsed/refractory disease. Safety analyses included reporting of AEs using crude and exposure-adjusted incidence rates.
RESULTS


The median follow-up duration was 16.84 months (range, 7.4-28 months) for both daratumumab-treated and comparator-treated patients. Discontinuation for any reason occurred less often with daratumumab (22% vs. 33.9%), although discontinuation because of AEs occurred at similar rates (25% vs. 26%) as did deaths owing to AEs (2.25% vs. 1.84%). When adjusted for exposure, neutropenia, lymphopenia, diarrhea, fatigue, dyspnea, pneumonia, and hypertension were the only common grade 3/4 AEs reported more often with daratumumab than with the comparators. The prevalence of common grade 3/4 AEs with daratumumab were < 7% apart from neutropenia, lymphopenia, and pneumonia (45.9% vs. 32.3%, 13% vs. 7.5%, and 10.6% vs. 7.2%, respectively). Grade 3/4 daratumumab infusion-related reactions happened in 3.8% of patients. The majority of infusion-related reactions occurred after the first infusion.
CONCLUSIONS


These results from an integrated analysis support a favorable benefit/risk profile of daratumumab in patients with MM.",2020,"The prevalence of common grade 3/4 AEs with daratumumab were < 7% apart from neutropenia, lymphopenia, and pneumonia (45.9% vs. 32.3%, 13% vs. 7.5%, and 10.6% vs. 7.2%, respectively).","['patients with MM', 'Data were pooled from 5 completed phase III randomized controlled studies that had included 1798 daratumumab-treated and 1797 comparator-treated patients with MM as a first line in both transplant-eligible and transplant-ineligible patients and for relapsed/refractory disease', 'Patients With Multiple Myeloma']",[],"['exposure, neutropenia, lymphopenia, diarrhea, fatigue, dyspnea, pneumonia, and hypertension', 'reporting of AEs using crude and exposure-adjusted incidence rates', 'neutropenia, lymphopenia, and pneumonia', 'majority of infusion-related reactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",[],"[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.125714,"The prevalence of common grade 3/4 AEs with daratumumab were < 7% apart from neutropenia, lymphopenia, and pneumonia (45.9% vs. 32.3%, 13% vs. 7.5%, and 10.6% vs. 7.2%, respectively).","[{'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Al Hadidi', 'Affiliation': 'Section of Hematology and Oncology, Baylor College of Medicine, Houston, TX. Electronic address: hadidi@bcm.edu.'}, {'ForeName': 'Courtney Nicole', 'Initials': 'CN', 'LastName': 'Miller-Chism', 'Affiliation': 'Section of Hematology and Oncology, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Rammurti', 'Initials': 'R', 'LastName': 'Kamble', 'Affiliation': 'Section of Hematology and Oncology, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Mims', 'Affiliation': 'Section of Hematology and Oncology, Baylor College of Medicine, Houston, TX.'}]","Clinical lymphoma, myeloma & leukemia",['10.1016/j.clml.2020.04.004']
1367,30365464,Everolimus and Long-term Clinical Outcomes in Kidney Transplant Recipients: A Registry-based 10-year Follow-up of 5 Randomized Trials.,"BACKGROUND


Data regarding the long-term efficacy of everolimus-based immunosuppression for kidney transplantation are lacking. Existing randomized controlled trials are limited by short follow-up duration which limits capacity to assess impact on graft and patient survival.
METHODS


We linked individual trial participants to the Australian and New Zealand Dialysis and Transplant Registry. Using a 1-step meta-analysis approach, we investigated the 10-year risk of graft loss, mortality and graft function in 349 participants from 5 randomized trials of everolimus-based immunosuppression.
RESULTS


Two hundred forty-two patients randomized to everolimus and 107 control patients were followed for a median of 9 years (interquartile range, 7.1, 9.8 y). There were no significant differences in the risk of all-cause graft loss (adjusted hazard ratio [HR], 1.16; 95% confidence interval [CI], 0.69-1.94), mortality (adjusted HR, 1.51; 95% CI, 0.78-2.93) and death-censored graft loss in everolimus versus control (adjusted HR, 1.00; 95% CI, 0.50-2.01). For patients in the early initiation (de novo or <6-month conversion) everolimus trials (n = 279), decline in estimated glomerular filtration rate did not significantly differ with control (mean difference in the slope of estimated glomerular filtrate rate, 0.01 mL/min per 1.73 m [-0.06 to +0.09]).
CONCLUSIONS


This registry-based analysis with long-term follow-up found no differences in graft and recipient survival or graft function for everolimus over current standard of care.",2019,"This registry-based analysis with long-term follow-up found no differences in graft and recipient survival, or graft function for everolimus over current standard-of-care.","['349 participants from five randomised-trials of', 'Two-hundred and forty-two patients randomised to', 'Kidney Transplant Recipients', 'individual trial participants to the Australian and New Zealand Dialysis and Transplant Registry']","['everolimus-based immunosuppression', 'everolimus', 'Everolimus']","['graft and recipient survival, or graft function', 'glomerular filtration rate (eGFR', 'death-censored graft loss', 'risk of all-cause graft loss', 'mortality']","[{'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}]","[{'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",349.0,0.427661,"This registry-based analysis with long-term follow-up found no differences in graft and recipient survival, or graft function for everolimus over current standard-of-care.","[{'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Ying', 'Affiliation': 'Renal Medicine, Royal Prince Alfred Hospital, Kidney Node at Charles Perkins Centre, Sydney Medical School, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Germaine', 'Initials': 'G', 'LastName': 'Wong', 'Affiliation': ""Centre for Transplant and Renal Research, Westmead Hospital, Centre for Kidney Research, The Children's Hospital at Westmead, NSW, Australia.""}, {'ForeName': 'Wai H', 'Initials': 'WH', 'LastName': 'Lim', 'Affiliation': 'Department of Renal Medicine, Sir Charles Gairdner Hospital, School of Medicine, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Clayton', 'Affiliation': 'Central and Northern Adelaide Renal and Transplantation Services, South Australia, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kanellis', 'Affiliation': 'Department of Nephrology, Monash Health, Clayton, Centre for Inflammatory Diseases Department of Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Pilmore', 'Affiliation': 'Department of Renal Medicine, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Campbell', 'Affiliation': 'Department of Renal Medicine, University of Queensland at Princess Alexandria Hospital, Woolloongabba, QLD, Australia.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': ""O'Connell"", 'Affiliation': 'Department of Renal Medicine, Westmead Hospital, Westmead, NSW, Australia.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Russ', 'Affiliation': 'Central and Northern Adelaide Renal and Transplantation Services, South Australia, Australia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Chadban', 'Affiliation': 'Renal Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}]",Transplantation,['10.1097/TP.0000000000002499']
1368,31813076,"Effects of Depression, Stigma and Intimate Partner Violence on Postpartum Women's Adherence and Engagement in HIV Care in Kenya.","We explored the association between HIV-related stigma and experiences of intimate partner violence (IPV) and depression with viral load suppression, and medication and visit adherence in postpartum women receiving lifelong antiretroviral therapy (ART) (N = 200). We administered a cross-sectional survey to 200 women with HIV at 12 months postpartum who were enrolled in the MOTIVATE trial. The MOTIVATE study is a cluster-randomized trial evaluating the impact of community mentor mothers and text messaging on PMTCT outcomes in southwestern Kenya. Simple and multivariable logistic regression analysis was performed in STATA. Women who experienced stigma or IPV were more likely to miss clinic visits (internalized stigma aOR 1.30 95%CI 1.03-1.64; anticipated stigma aOR 1.20 95%CI 1.04-1.42; IPV aOR 15.71 95%CI 1.47-167.80), report difficulty taking ART drugs (internalized stigma aOR 1.32 95%CI 1.10-1.58; anticipated stigma aOR 1.14 95%CI 1.01-1.30) and not taking medication as prescribed (IPV aOR 2.00 95%CI 1.05-3.74). Depression was additionally associated with decreased odds of viral load suppression (aOR 0.16 95%CI 0.04-0.76). There is need to develop tailored psychosocial interventions within PMTCT programs that appropriately address mental health, stigma, and violence.",2020,Depression was additionally associated with decreased odds of viral load suppression (aOR 0.16 95%CI 0.04-0.76).,"['postpartum women receiving lifelong antiretroviral therapy (ART) (N\u2009=\u2009200', '200 women with HIV at 12\xa0months postpartum who were enrolled', 'community mentor mothers and text messaging on PMTCT outcomes in southwestern Kenya', ""Postpartum Women's Adherence and Engagement in HIV Care in Kenya""]",[],"['Depression', 'HIV-related stigma and experiences of intimate partner violence (IPV) and depression with viral load suppression, and medication and visit adherence', 'viral load suppression', 'Depression, Stigma and Intimate Partner Violence', 'stigma or IPV', 'miss clinic visits']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C4274169', 'cui_str': 'Entire period of life between birth and death'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}]",[],"[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]",200.0,0.173199,Depression was additionally associated with decreased odds of viral load suppression (aOR 0.16 95%CI 0.04-0.76).,"[{'ForeName': 'Maricianah', 'Initials': 'M', 'LastName': 'Onono', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, P.O. Box 19464-00202, Nairobi, Kenya. maricianah@gmail.com.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Odwar', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, P.O. Box 19464-00202, Nairobi, Kenya.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Abuogi', 'Affiliation': 'Department of Pediatrics, University of Colorado Denver, Aurora, CO, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Owuor', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, P.O. Box 19464-00202, Nairobi, Kenya.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Helova', 'Affiliation': 'Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bukusi', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, P.O. Box 19464-00202, Nairobi, Kenya.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Turan', 'Affiliation': 'Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hampanda', 'Affiliation': 'Center for Global Health, Colorado School of Public Health, Aurora, CO, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02750-y']
1369,30366115,Ovarian Reserve and Assisted Reproductive Technique Outcomes After Laparoscopic Proximal Tubal Occlusion or Salpingectomy in Women with Hydrosalpinx Undergoing in Vitro Fertilization: A Randomized Controlled Trial.,"STUDY OBJECTIVE


To evaluate the outcomes of assisted reproductive technology (ART) after proximal tubal occlusion (PTO) or salpingectomy in patients with hydrosalpinx undergoing in vitro fertilization-embryo transfer (IVF-ET).
DESIGN


Randomized controlled trial (Canadian Task Force classification I).
SETTING


All India Institute of Medical Sciences, New Delhi, India.
PATIENTS


A total of 165 patients were randomized and subsequently allocated to a PTO group (n = 83) or a salpingectomy group (n = 82).
INTERVENTIONS


PTO and salpingectomy.
MEASUREMENTS AND MAIN RESULTS


Following surgery, compared with the PTO group, the salpingectomy group showed significant decreases in the ovarian reserve parameters serum anti-Müllerian hormone (AMH; 3.7 ng/mL vs 2.6 ng/mL; p ˂ .001) and antral follicle count (AFC; 10.6 vs 8.6; p ˂ .001). The salpingectomy group also required a significantly higher dose of gonadotropins (3901 vs 3260; p ˂ .001) and more days of stimulation (11.3 vs 10.2; p ˂ .001) compared with the PTO group. The salpingectomy group had a significantly lower fertilization rate (0.74 vs 0.83; p ˂ .001) and a lower number of grade 1 embryos (4.1 vs 5.6; p = .02); however, there was no significant difference between the 2 groups with respect to rates of implantation (22.8% vs 23.7%; p = .87), clinical pregnancy (26.3% vs 33.7%, p = .25), live birth (27.5% vs 32.5%; p = .42), and miscarriage (4.7% vs 3.5%; p = .90) CONCLUSIONS: PTO is a superior to salpingectomy for the surgical management of patients with hydrosalpinx undergoing IVF-ET in terms of ovarian reserve. However, the 2 surgical techniques are associated with comparable pregnancy rates.",2019,"The salpingectomy group had a significantly lower fertilization rate (0.74 vs 0.83; p ˂ .001) and a lower number of grade 1 embryos (4.1 vs 5.6; p = .02); however, there was no significant difference between the 2 groups with respect to rates of implantation (22.8% vs 23.7%; p = .87), clinical pregnancy (26.3% vs 33.7%, p = .25), live birth (27.5% vs 32.5%; p = .42), and miscarriage (4.7% vs 3.5%; p = .90)","['165 patients', 'patients with hydrosalpinx undergoing in vitro fertilization-embryo transfer (IVF-ET', 'All India Institute of Medical Sciences, New Delhi, India', 'patients with hydrosalpinx undergoing IVF-ET in terms of ovarian reserve', 'Women with Hydrosalpinx Undergoing in Vitro Fertilization']","['assisted reproductive technology (ART) after proximal tubal occlusion (PTO) or salpingectomy', 'salpingectomy group', 'Laparoscopic Proximal Tubal Occlusion or Salpingectomy', 'PTO']","['fertilization rate', 'ovarian reserve parameters serum anti-Müllerian hormone', 'rates of implantation', 'live birth', 'miscarriage', 'antral follicle count', 'Ovarian Reserve and Assisted Reproductive Technique Outcomes', 'gonadotropins', 'clinical pregnancy']","[{'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221376', 'cui_str': 'Hydrosalpinx (disorder)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0872104', 'cui_str': 'Assisted Reproductive Technologies'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0041275', 'cui_str': 'Tubal Occlusion'}, {'cui': 'C0041271', 'cui_str': 'Tubectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0035151', 'cui_str': 'Reproduction Techniques'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",165.0,0.229313,"The salpingectomy group had a significantly lower fertilization rate (0.74 vs 0.83; p ˂ .001) and a lower number of grade 1 embryos (4.1 vs 5.6; p = .02); however, there was no significant difference between the 2 groups with respect to rates of implantation (22.8% vs 23.7%; p = .87), clinical pregnancy (26.3% vs 33.7%, p = .25), live birth (27.5% vs 32.5%; p = .42), and miscarriage (4.7% vs 3.5%; p = .90)","[{'ForeName': 'Chithira Pulimoottil', 'Initials': 'CP', 'LastName': 'Vignarajan', 'Affiliation': 'ART Center, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Neena', 'Initials': 'N', 'LastName': 'Malhotra', 'Affiliation': 'ART Center, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India. Electronic address: malhotraneena@yahoo.com.'}, {'ForeName': 'Neeta', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'ART Center, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2018.10.013']
1370,31654501,Alterations in retinal arteriolar microvascular structure associate with higher treatment burden in patients with diabetic macular oedema: results from a 12-month prospective clinical trial.,"PURPOSE


This study was based on data from a 12-month prospective clinical trial and aimed to examine changes in retinal microvascular structure in eyes treated with intravitreal aflibercept in combination with focal/grid laser photocoagulation for diabetic macular oedema (DME).
METHODS


We included 32 treatment naïve eyes of 22 patients with centre involving DME. The treatment algorithm comprised a loading phase of three monthly injections of aflibercept and focal/grid laser photocoagulation [baseline (BL)-month 3 (M3)] followed by a pro re nata (PRN) aflibercept phase until month 12 (M12). Eyes were divided into groups with and without need for PRN treatment after loading. Parameters of retinal microvascular structure were measured in 45° optic disc centred fundus images at BL, M3 and M12 using a semi-automated software (VAMPIRE®, Vessel Assessment and Measurement Platform for Images of the Retina, Universities of Dundee and Edinburgh, UK).
RESULTS


A significant decrease in retinal arteriolar calibre was demonstrated at both M3 (-11.2 μm, p = 0.005) and M12 (-11.5 μm, p = 0.04) as compared to BL in eyes that needed PRN treatment during follow-up. In contrast, arteriolar calibre remained unchanged in eyes without need for PRN treatment (M3: -1.6 μm, p = 0.79 and M12: -7.0 μm, p = 0.22). For retinal venules, vessel calibre decreased both in eyes with and without need for PRN therapy at M3 (-9.5 μm, p = 0.01 and -11.6 μm, p = 0.01) as well as at M12 (-15.6 μm, p = 0.001 and -11.0 μm, p = 0.04).
CONCLUSION


Early changes in retinal arteriolar calibre are associated with an increased treatment burden during the first year of DME treatment.",2020,"For retinal venules, vessel calibre decreased both in eyes with and without need for PRN therapy at M3 (-9.5 μm, p = 0.01","['32 treatment naïve eyes of 22 patients with centre involving DME', 'patients with diabetic macular oedema', 'diabetic macular oedema (DME']","['aflibercept and focal/grid laser photocoagulation [baseline (BL)-month 3 (M3)] followed by a pro re nata (PRN) aflibercept', 'intravitreal aflibercept in combination with focal/grid laser photocoagulation']","['vessel calibre', 'arteriolar calibre', 'retinal microvascular structure', 'retinal arteriolar calibre']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0641456', 'cui_str': 'DMES'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0067792', 'cui_str': 'NATA'}]","[{'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}]",32.0,0.0169828,"For retinal venules, vessel calibre decreased both in eyes with and without need for PRN therapy at M3 (-9.5 μm, p = 0.01","[{'ForeName': 'Søren L', 'Initials': 'SL', 'LastName': 'Blindbaek', 'Affiliation': 'Department of Ophthalmology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Peto', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Grauslund', 'Affiliation': 'Department of Ophthalmology, Odense University Hospital, Odense, Denmark.'}]",Acta ophthalmologica,['10.1111/aos.14278']
1371,31661693,The Effectiveness of Action Observation Therapy Based on Mirror Neuron Theory in Chinese Patients with Apraxia of Speech after Stroke.,"OBJECTIVE


The present study aimed to evaluate the efficacy of action observation therapy (AOT) on apraxia of speech (AOS) in patients after stroke.
MATERIALS AND METHODS


Forty-two patients diagnosed with AOS after stroke were randomly divided into an experimental group (n = 21) and a control group (n = 21). Both groups received 30 min of conventional language therapy twice daily, 5 days a week for 4 weeks. The patients in the experimental group additionally received 20 min of AOT before 10 min language therapy each day. The speech function and aphasia severity of the 2 groups were assessed using the speech apraxia assessment method of the China Rehabilitation Research Center, Western Aphasia Battery (WAB), and the Boston Diagnostic Aphasia Examination before and after treatment.
RESULTS


AOS and WAB scores increased significantly after treatment in both groups (p < 0.05). AOS and WAB scores exhibited significant differences between the experimental group and the control group after training (p < 0.05). The response rate in the experimental group was significantly higher than that in the control group (p < 0.05).
CONCLUSION


AOT based on mirror neuron theory may improve language function in patients with AOS after stroke.",2019,"The response rate in the experimental group was significantly higher than that in the control group (p < 0.05).
","['Chinese Patients with Apraxia of Speech after Stroke', 'Forty-two patients diagnosed with AOS after stroke', 'patients with AOS after stroke', 'patients after stroke']","['Action Observation Therapy', 'conventional language therapy', 'action observation therapy (AOT']","['AOS and WAB scores', 'apraxia of speech (AOS', 'speech function and aphasia severity', 'speech apraxia assessment method of the China Rehabilitation Research Center, Western Aphasia Battery (WAB), and the Boston Diagnostic Aphasia Examination', 'response rate', 'language function']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264611', 'cui_str': 'Apraxia of Phonation'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}]","[{'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0023017', 'cui_str': 'Language Therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0264611', 'cui_str': 'Apraxia of Phonation'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1514830', 'cui_str': 'Rehabilitation Research'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0451580', 'cui_str': 'Western aphasia battery (assessment scale)'}, {'cui': 'C0451036', 'cui_str': 'Boston Diagnostic Aphasia Examination'}, {'cui': 'C0023008', 'cui_str': 'Languages'}]",42.0,0.0250256,"The response rate in the experimental group was significantly higher than that in the control group (p < 0.05).
","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'You', 'Affiliation': 'Department of Rehabilitation, Brain Hospital Affiliated to Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation, Brain Hospital Affiliated to Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Wenli', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Zhongda Hospital Southeast University, Nanjing, China.'}, {'ForeName': 'Sicong', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Rao', 'Affiliation': 'Department of Rehabilitation, Brain Hospital Affiliated to Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation, Brain Hospital Affiliated to Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Chunlei', 'Initials': 'C', 'LastName': 'Shan', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China, neuroscl@163.com.'}]",European neurology,['10.1159/000503960']
1372,30528307,Effectiveness of a Pre-emptive Preoperative Belladonna and Opium Suppository on Postoperative Urgency and Pain After Ureteroscopy.,"PURPOSE


Postoperative ureteroscopy patients can develop bladder spasms, complaints of pain, and the urgent need to void during emergence from anesthesia. Discomfort leads to patient agitation, resulting in a risk to patient safety. The purpose of this study was to determine the effectiveness of a preemptive preoperative belladonna and opium (B + O) suppository on postoperative bladder comfort, narcotic requirements, and length of stay of ureteroscopy patients.
DESIGN


A prospective double-blind study was conducted.
METHODS


Fifty adult outpatients scheduled for ureteroscopy were assigned to routine care or a B + O suppository immediately after anesthesia induction. Urinary urgency and pain were assessed every 15 minutes.
FINDINGS


Urgency significantly decreased in the B+O group, with less than half reporting urgency at discharge.
CONCLUSIONS


Pre-emptive preoperative administration of a B + O suppository before ureteroscopy results in decreased urinary urgency during the postoperative recovery. Pre-emptive preoperative interventions can result in positive outcomes before discharge.",2019,"CONCLUSIONS


Pre-emptive preoperative administration of a B + O suppository before ureteroscopy results in decreased urinary urgency during the postoperative recovery.",['Fifty adult outpatients scheduled for'],"['ureteroscopy', 'routine care or a B + O suppository', 'preemptive preoperative belladonna and opium (B + O) suppository', 'Pre-emptive Preoperative Belladonna and Opium Suppository']","['Urinary urgency and pain', 'Postoperative Urgency and Pain', 'postoperative bladder comfort, narcotic requirements, and length of stay of ureteroscopy patients', 'Urgency', 'urinary urgency']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0038854', 'cui_str': 'Suppository'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0301370', 'cui_str': 'atropa belladona extract'}, {'cui': 'C0029112', 'cui_str': 'Opium'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]","[{'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",50.0,0.0342222,"CONCLUSIONS


Pre-emptive preoperative administration of a B + O suppository before ureteroscopy results in decreased urinary urgency during the postoperative recovery.","[{'ForeName': 'Susan Jane', 'Initials': 'SJ', 'LastName': 'Fetzer', 'Affiliation': ''}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Goodwin', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Stanizzi', 'Affiliation': ''}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2018.09.011']
1373,30414998,Barbed Suture versus Conventional Suture for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy: Randomized Controlled Clinical Trial.,"STUDY OBJECTIVE


To determine the surgical time, suture time, presence of postoperative dyspareunia, and complications that occur after closing the vaginal cuff with a barbed suture compared with conventional suture.
DESIGN


A randomized, controlled clinical trial (Canadian Task Force classification I).
SETTING


Private gynecologic clinic in Medellin, Colombia.
PATIENTS


One hundred fifty women who underwent total laparoscopic hysterectomy for benign pathology.
INTERVENTIONS


The patients underwent total laparoscopic hysterectomy with intracorporeal closure of the vaginal cuff and were randomized to 2 groups, 1 using a barbed suture (V-Loc 90; Medtronic/Covidien, New Haven, CT) and 1 using polyglactin 910 (coated Vicryl suture; Ethicon/Johnson & Johnson, New Brunswick, NJ).
MEASUREMENTS AND MAIN RESULTS


The total operative time, closing time of the vaginal vault, presence of complications in the cuff, and incidence of postoperative dyspareunia were recorded. The patients were evaluated at a postoperative office visit 2 weeks after the procedure and by telephone interview at 24 weeks. Seventy-five patients were included in the barbed suture group and 75 patients in the polyglactin 910 group. The average time to complete the suture of the vaginal cuff was 12.01 minutes (± 5.37 standard deviation) for the barbed suture group versus 13.49 minutes (± 6.48) in the polyglactin 910 group (95% confidence interval, -.44 to 3.4; p = .130). Blood loss was 31.56 ± 22.93 mL in the barbed suture group versus 30.82 ± 21.75 mL in the polyglactin 910 group (95% confidence interval, -7.95 to 6.47; p = .840). The frequency of postoperative events such as hematoma, cellulitis, cuff dehiscence, fever, emergency consultation, and hospitalization was not statistically significant between groups. No statistically significant difference was found regarding deep dyspareunia at 24 postoperative weeks.
CONCLUSION


No differences were found in surgical time or frequency of adverse events when comparing patients after vaginal cuff closure with barbed suture versus polyglactin 910.",2019,No differences were found in surgical time or frequency of adverse events when comparing patients after vaginal cuff closure with barbed suture versus polyglactin 910.,"['Seventy-five patients were included in the barbed suture group and 75 patients in the polyglactin 910 group', 'Total Laparoscopic Hysterectomy', 'One hundred fifty women who underwent', 'for benign pathology', 'Private gynecologic clinic in Medellin, Colombia']","['barbed suture compared with conventional suture', 'total laparoscopic hysterectomy with intracorporeal closure of the vaginal cuff', 'Barbed Suture versus Conventional Suture', 'total laparoscopic hysterectomy', 'barbed suture versus polyglactin', 'barbed suture (V-Loc 90; Medtronic/Covidien, New Haven, CT) and 1 using polyglactin 910 (coated Vicryl suture; Ethicon/Johnson & Johnson, New Brunswick, NJ']","['total operative time, closing time of the vaginal vault, presence of complications in the cuff, and incidence of postoperative dyspareunia', 'deep dyspareunia', 'surgical time, suture time, presence of postoperative dyspareunia, and complications', 'Blood loss', 'surgical time or frequency of adverse events', 'frequency of postoperative events such as hematoma, cellulitis, cuff dehiscence, fever, emergency consultation, and hospitalization', 'average time to complete the suture of the vaginal cuff']","[{'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0032495', 'cui_str': 'Polygalactin 910'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy (procedure)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy (procedure)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C1550321', 'cui_str': 'Vaginal cuff'}, {'cui': 'C0032494', 'cui_str': 'Poly(Lactide-Co-Glycoside)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0032495', 'cui_str': 'Polygalactin 910'}, {'cui': 'C1576039', 'cui_str': 'Vicryl suture (physical object)'}, {'cui': 'C0027963', 'cui_str': 'New Brunswick'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0549115', 'cui_str': 'Structure of vaginal vault'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse (finding)'}, {'cui': 'C0423747', 'cui_str': 'Deep pain on intercourse (finding)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1550321', 'cui_str': 'Vaginal cuff'}]",75.0,0.0741117,No differences were found in surgical time or frequency of adverse events when comparing patients after vaginal cuff closure with barbed suture versus polyglactin 910.,"[{'ForeName': 'Claudia C', 'Initials': 'CC', 'LastName': 'López', 'Affiliation': 'Clinica del Prado (Drs. López, De Los Ríos, Arango, Cifuentes, Vásquez, Castañeda, Almanza, and Jiménez), Medellín, Colombia, and the School of Medicine (Drs. González, Vásquez-Trespalacios, and Serna), CES University, Medellín, Colombia.'}, {'ForeName': 'José F De Los', 'Initials': 'JFL', 'LastName': 'Ríos', 'Affiliation': 'Clinica del Prado (Drs. López, De Los Ríos, Arango, Cifuentes, Vásquez, Castañeda, Almanza, and Jiménez), Medellín, Colombia, and the School of Medicine (Drs. González, Vásquez-Trespalacios, and Serna), CES University, Medellín, Colombia.'}, {'ForeName': 'Yenyffer', 'Initials': 'Y', 'LastName': 'González', 'Affiliation': 'Clinica del Prado (Drs. López, De Los Ríos, Arango, Cifuentes, Vásquez, Castañeda, Almanza, and Jiménez), Medellín, Colombia, and the School of Medicine (Drs. González, Vásquez-Trespalacios, and Serna), CES University, Medellín, Colombia.'}, {'ForeName': 'Elsa María', 'Initials': 'EM', 'LastName': 'Vásquez-Trespalacios', 'Affiliation': 'Clinica del Prado (Drs. López, De Los Ríos, Arango, Cifuentes, Vásquez, Castañeda, Almanza, and Jiménez), Medellín, Colombia, and the School of Medicine (Drs. González, Vásquez-Trespalacios, and Serna), CES University, Medellín, Colombia.. Electronic address: evasquez@ces.edu.co.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Serna', 'Affiliation': 'Clinica del Prado (Drs. López, De Los Ríos, Arango, Cifuentes, Vásquez, Castañeda, Almanza, and Jiménez), Medellín, Colombia, and the School of Medicine (Drs. González, Vásquez-Trespalacios, and Serna), CES University, Medellín, Colombia.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Arango', 'Affiliation': 'Clinica del Prado (Drs. López, De Los Ríos, Arango, Cifuentes, Vásquez, Castañeda, Almanza, and Jiménez), Medellín, Colombia, and the School of Medicine (Drs. González, Vásquez-Trespalacios, and Serna), CES University, Medellín, Colombia.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Cifuentes', 'Affiliation': 'Clinica del Prado (Drs. López, De Los Ríos, Arango, Cifuentes, Vásquez, Castañeda, Almanza, and Jiménez), Medellín, Colombia, and the School of Medicine (Drs. González, Vásquez-Trespalacios, and Serna), CES University, Medellín, Colombia.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Vásquez', 'Affiliation': 'Clinica del Prado (Drs. López, De Los Ríos, Arango, Cifuentes, Vásquez, Castañeda, Almanza, and Jiménez), Medellín, Colombia, and the School of Medicine (Drs. González, Vásquez-Trespalacios, and Serna), CES University, Medellín, Colombia.'}, {'ForeName': 'Juan D', 'Initials': 'JD', 'LastName': 'Castañeda', 'Affiliation': 'Clinica del Prado (Drs. López, De Los Ríos, Arango, Cifuentes, Vásquez, Castañeda, Almanza, and Jiménez), Medellín, Colombia, and the School of Medicine (Drs. González, Vásquez-Trespalacios, and Serna), CES University, Medellín, Colombia.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Almanza', 'Affiliation': 'Clinica del Prado (Drs. López, De Los Ríos, Arango, Cifuentes, Vásquez, Castañeda, Almanza, and Jiménez), Medellín, Colombia, and the School of Medicine (Drs. González, Vásquez-Trespalacios, and Serna), CES University, Medellín, Colombia.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Jiménez', 'Affiliation': 'Clinica del Prado (Drs. López, De Los Ríos, Arango, Cifuentes, Vásquez, Castañeda, Almanza, and Jiménez), Medellín, Colombia, and the School of Medicine (Drs. González, Vásquez-Trespalacios, and Serna), CES University, Medellín, Colombia.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2018.08.030']
1374,32408883,Neurally adjusted ventilatory assist versus pressure support ventilation: a randomized controlled feasibility trial performed in patients at risk of prolonged mechanical ventilation.,"BACKGROUND


The clinical effectiveness of neurally adjusted ventilatory assist (NAVA) has yet to be demonstrated, and preliminary studies are required. The study aim was to assess the feasibility of a randomized controlled trial (RCT) of NAVA versus pressure support ventilation (PSV) in critically ill adults at risk of prolonged mechanical ventilation (MV).
METHODS


An open-label, parallel, feasibility RCT (n = 78) in four ICUs of one university-affiliated hospital. The primary outcome was mode adherence (percentage of time adherent to assigned mode), and protocol compliance (binary-≥ 65% mode adherence). Secondary exploratory outcomes included ventilator-free days (VFDs), sedation, and mortality.
RESULTS


In the 72 participants who commenced weaning, median (95% CI) mode adherence was 83.1% (64.0-97.1%) and 100% (100-100%), and protocol compliance was 66.7% (50.3-80.0%) and 100% (89.0-100.0%) in the NAVA and PSV groups respectively. Secondary outcomes indicated more VFDs to D28 (median difference 3.0 days, 95% CI 0.0-11.0; p = 0.04) and fewer in-hospital deaths (relative risk 0.5, 95% CI 0.2-0.9; p = 0.032) for NAVA. Although overall sedation was similar, Richmond Agitation and Sedation Scale (RASS) scores were closer to zero in NAVA compared to PSV (p = 0.020). No significant differences were observed in duration of MV, ICU or hospital stay, or ICU, D28, and D90 mortality.
CONCLUSIONS


This feasibility trial demonstrated good adherence to assigned ventilation mode and the ability to meet a priori protocol compliance criteria. Exploratory outcomes suggest some clinical benefit for NAVA compared to PSV. Clinical effectiveness trials of NAVA are potentially feasible and warranted.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT01826890. Registered 9 April 2013.",2020,"Secondary outcomes indicated more VFDs to D28 (median difference 3.0 days, 95% CI 0.0-11.0; p = 0.04) and fewer in-hospital deaths (relative risk 0.5, 95% CI 0.2-0.9; p = 0.032) for NAVA.","['patients at risk of prolonged mechanical ventilation', 'critically ill adults at risk of prolonged mechanical ventilation (MV', 'n\u2009=\u200978) in four ICUs of one university-affiliated hospital']","['RCT', 'neurally adjusted ventilatory assist (NAVA', 'NAVA versus pressure support ventilation (PSV', 'Neurally adjusted ventilatory assist versus pressure support ventilation', 'NAVA']","['hospital deaths', 'overall sedation', 'adherence', 'Richmond Agitation and Sedation Scale (RASS) scores', 'protocol compliance', 'mode adherence (percentage of time adherent to assigned mode), and protocol compliance (binary-≥\u200965% mode adherence', 'ventilator-free days (VFDs), sedation, and mortality', 'VFDs to D28', 'duration of MV, ICU or hospital stay, or ICU, D28, and D90 mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0277608', 'cui_str': 'Death in hospital'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0525058', 'cui_str': 'Protocol Compliance'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.234937,"Secondary outcomes indicated more VFDs to D28 (median difference 3.0 days, 95% CI 0.0-11.0; p = 0.04) and fewer in-hospital deaths (relative risk 0.5, 95% CI 0.2-0.9; p = 0.032) for NAVA.","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Hadfield', 'Affiliation': ""Critical Care, King's College Hospital, London, UK. daniel.hadfield@nhs.net.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Rose', 'Affiliation': ""Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, UK.""}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Reid', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Cornelius', 'Affiliation': 'Faculty of Medicine, School of Public Health, Imperial College, London, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hart', 'Affiliation': ""Centre for Human and Applied Physiological Sciences, King's College London, London, UK.""}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Finney', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Penhaligon', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Molai', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Clair', 'Initials': 'C', 'LastName': 'Harris', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Saha', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Noble', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Clarey', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Thompson', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Phillip A', 'Initials': 'PA', 'LastName': 'Hopkins', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Gerrard F', 'Initials': 'GF', 'LastName': 'Rafferty', 'Affiliation': ""Centre for Human and Applied Physiological Sciences, King's College London, London, UK.""}]","Critical care (London, England)",['10.1186/s13054-020-02923-5']
1375,32409195,Exploring the Impact of Lung Cancer Screening on Lung Cancer Mortality of Smokers With Obstructive Lung Disease: Analysis of the NLST-ACRIN Cohort.,"BACKGROUND


Lung Cancer (LC) screening with low dose chest computed tomography (LDCT) in smokers reduces LC mortality. Patients with Obstructive Lung Disease (OLD) are at high risk for LC. The potential effect of LC screening in this population is unknown.
OBJECTIVE


To determine if screening with LDCT reduces LC mortality in smokers with spirometrically defined OLD.
METHODS


The National Lung Screening Trial-American College of Radiology Imaging Network (NLST-ACRIN) study included 13,831 subjects (55-74 years of age with ≥30 pack-year history of smoking) that had a baseline spirometry. Randomly assigned to LDCT or Chest X-ray, all had 3 annual rounds of screening. LC mortality was compared between the LDCT and chest X-ray arms during the 1st year and at 6 years of follow up. Landmark analysis explored LC mortality differences between arms after the first year.
RESULTS


From the 4584 subjects with OLD (FEV1/FVC <0.7), 152 (3.3%) died from LC. Multivariable analysis showed that screening trended to decrease LC mortality at 6 years (HR, 95%CI: 0.75, 0.55-1.04, p=0.09). During the 1st year no differences were found between arms (p=0.65). However, after this year, LDCT significantly decreased LC mortality (HR, 95%CI: 0.63, 0.44-0.91, p=0.01). The number needed to screen to avoid one LC death in these subjects was 108 while in those without OLD was 218.
CONCLUSIONS


LC screening with LDCT in smokers with spirometrically diagnosed OLD, showed a trend to reduce lung cancer mortality but a study with a larger number of patients and with a more robust design would be needed to confirm these findings.",2020,"However, after this year, LDCT significantly decreased LC mortality (HR, 95%CI: 0.63, 0.44-0.91, p=0.01).","['smokers with spirometrically defined OLD', 'Patients with Obstructive Lung Disease (OLD', 'The National Lung Screening Trial-American College of Radiology Imaging Network (NLST-ACRIN) study included 13,831 subjects (55-74 years of age with ≥30 pack-year history of smoking) that had a baseline spirometry', '4584 subjects with OLD (FEV1/FVC <0.7), 152 (3.3%) died from LC', 'Smokers With Obstructive Lung Disease', 'smokers with spirometrically diagnosed OLD']","['Lung Cancer (LC) screening with low dose chest computed tomography (LDCT', 'LC screening', 'LDCT', 'Lung Cancer Screening', 'LC screening with LDCT']","['LC mortality differences', 'Lung Cancer Mortality', 'LC mortality', 'lung cancer mortality']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0600260', 'cui_str': 'Obstructive airways disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4075962', 'cui_str': 'Low dose computed tomography of thorax'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}]","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",13831.0,0.0791144,"However, after this year, LDCT significantly decreased LC mortality (HR, 95%CI: 0.63, 0.44-0.91, p=0.01).","[{'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'de-Torres', 'Affiliation': 'Pulmonary Department, Clínica Universidad de Navarra, Pamplona, Spain; Navarra Health Research Institute (IDISNA), Pamplona, Spain. Electronic address: jupa65@hotmail.com.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Wisnivesky', 'Affiliation': 'Divisions of General Internal Medicine and Pulmonary and Critical Care Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Gorka', 'Initials': 'G', 'LastName': 'Bastarrika', 'Affiliation': 'Divisions of General Internal Medicine and Pulmonary and Critical Care Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Radiology Department, Clínica Universidad de Navarra, Spain.'}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Wilson', 'Affiliation': 'Department of Medicine, University of Pittsburgh Medical Center, USA.'}, {'ForeName': 'Bartolome R', 'Initials': 'BR', 'LastName': 'Celli', 'Affiliation': 'Pulmonary Department, Brigham and Women Hospital, Boston, MA, USA.'}, {'ForeName': 'Javier J', 'Initials': 'JJ', 'LastName': 'Zulueta', 'Affiliation': 'Pulmonary Department, Clínica Universidad de Navarra, Pamplona, Spain.'}]",Archivos de bronconeumologia,['10.1016/j.arbres.2020.03.023']
1376,30350405,Three weeks of respiratory muscle endurance training improve the O 2  cost of walking and exercise tolerance in obese adolescents.,"Obese adolescents (OB) have an increased O 2  cost of exercise, attributable in part to an increased O 2  cost of breathing. In a previous work a short (3-week) program of respiratory muscle endurance training (RMET) slightly reduced in OB the O 2  cost of high-intensity cycling and improved exercise tolerance. We hypothesized that during treadmill walking the effects of RMET would be more pronounced than those observed during cycling. Sixteen OB (age 16.0 ± 0.8 years; body mass [BM] 127.7 ± 14.2 kg; body mass index 40.7 ± 4.0 kg/m 2  ) underwent to 3-week RMET (n = 8) superimposed to a multidisciplinary BM reduction program, or (CTRL, n = 8) only to the latter. Heart rate (HR) and pulmonary O 2  uptake ( <mml:math xmlns:mml=""http://www.w3.org/1998/Math/MathML""><mml:mover><mml:mi>V</mml:mi> <mml:mo>˙</mml:mo></mml:mover> </mml:math> O 2  ) were measured during incremental exercise and 12-min constant work rate (CWR) walking at 60% (moderate-intensity, MOD) and 120% (heavy-intensity, HEAVY) of the gas exchange threshold (GET). The O 2  cost of walking (aerobic energy expenditure per unit of covered distance) was calculated as <mml:math xmlns:mml=""http://www.w3.org/1998/Math/MathML""><mml:mover><mml:mi>V</mml:mi> <mml:mo>˙</mml:mo></mml:mover> </mml:math> O 2  /velocity. BM decreased (~4-5 kg) both in CTRL and in RMET. <mml:math xmlns:mml=""http://www.w3.org/1998/Math/MathML""><mml:mover><mml:mi>V</mml:mi> <mml:mo>˙</mml:mo></mml:mover> </mml:math> O 2  peak and GET were not affected by both interventions; the time to exhaustion increased following RMET. During MOD and HEAVY RMET decreased <mml:math xmlns:mml=""http://www.w3.org/1998/Math/MathML""><mml:mover><mml:mi>V</mml:mi> <mml:mo>˙</mml:mo></mml:mover> </mml:math> O 2,  the O 2  cost of walking (MOD: 0.130 ± 0.033 mL/kg/m [before] vs. 0.109 ± 0.027 [after], P = 0.03; HEAVY: 0.196 ± 0.031 [before] vs. 0.180 ± 0.025 [after], P = 0.02), HR and rates of perceived exertion; no significant changes were observed in CTRL. In OB a short RMET program lowered the O 2  cost of MOD and HEAVY walking and improved exercise tolerance. RMET could represent a useful adjunct in the control of obesity.",2018,math> O 2  peak and GET were not affected by both interventions; the time to exhaustion increased following RMET.,"['mml:math xmlns', 'Sixteen OB (age 16.0\xa0±\xa00.8\xa0years; body mass [BM] 127.7\xa0±\xa014.2\xa0kg; body mass index 40.7\xa0±\xa04.0', 'mover><mml', 'Obese adolescents (OB', 'obese adolescents']","['respiratory muscle endurance training (RMET', 'mml=""http://www.w3.org/1998/Math/MathML""><mml', 'multidisciplinary BM reduction program, or (CTRL, n\xa0', 'RMET', 'respiratory muscle endurance training']","['incremental exercise and 12-min constant work rate (CWR) walking', 'O 2  cost of walking and exercise tolerance', 'MOD and HEAVY walking and improved exercise tolerance', 'time to exhaustion', 'Heart rate (HR) and pulmonary O 2  uptake ( <mml:math xmlns', 'HR and rates of perceived exertion', 'BM', 'exercise tolerance']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0035231', 'cui_str': 'Ventilatory Muscles'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0026766', 'cui_str': 'Organ Dysfunction Syndrome, Multiple'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C3875470', 'cui_str': 'Improved exercise tolerance'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}]",16.0,0.0205563,math> O 2  peak and GET were not affected by both interventions; the time to exhaustion increased following RMET.,"[{'ForeName': 'Hailu K', 'Initials': 'HK', 'LastName': 'Alemayehu', 'Affiliation': 'Department of Medicine, University of Udine, Udine, Italy.'}, {'ForeName': 'Desy', 'Initials': 'D', 'LastName': 'Salvadego', 'Affiliation': 'Department of Medicine, University of Udine, Udine, Italy.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Isola', 'Affiliation': 'Department of Medicine, University of Udine, Udine, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Tringali', 'Affiliation': 'Istituto Auxologico Italiano, IRCCS, Experimental Laboratory for Auxo-endocrinological Research, Milan and Piancavallo (VB), Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'De Micheli', 'Affiliation': 'Istituto Auxologico Italiano, IRCCS, Experimental Laboratory for Auxo-endocrinological Research, Milan and Piancavallo (VB), Italy.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Caccavale', 'Affiliation': 'Istituto Auxologico Italiano, IRCCS, Experimental Laboratory for Auxo-endocrinological Research, Milan and Piancavallo (VB), Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Sartorio', 'Affiliation': 'Istituto Auxologico Italiano, IRCCS, Experimental Laboratory for Auxo-endocrinological Research, Milan and Piancavallo (VB), Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Grassi', 'Affiliation': 'Department of Medicine, University of Udine, Udine, Italy.'}]",Physiological reports,['10.14814/phy2.13888']
1377,31599746,Cold Snare Polypectomy in Patients Taking Dual Antiplatelet Therapy: A Randomized Trial of Discontinuation of Thienopyridines.,"INTRODUCTION


Cold snare polypectomy (CSP) is a safe and effective method for removing polyps ≤10 mm. The aim of this study was to compare the risk of clinically significant bleeding and thromboembolic events after CSP between stopping and continuing thienopyridines in patients taking dual antiplatelet therapy (DAPT).
METHODS


The study was a single-center, noninferiority, and randomized controlled study involving patients who received colonoscopy from October 2015 to October 2016. Patients receiving DAPT with polyps ≤10 mm were randomly assigned to either the DAPT group (patients continued DAPT) or the aspirin group (patients discontinued thienopyridines for 1 week). Primary outcome was clinically significant bleeding. Secondary outcomes included intraprocedural bleeding, nonsignificant hematochezia, and occurrence of thromboembolic events.
RESULTS


Forty-two patients with 104 eligible polyps were allocated to the DAPT group, and 45 patients with 101 eligible polyps were allocated to the aspirin group. Patient demographic characteristics including size, location, shape, and pathology of the removed polyps were similar in the 2 groups. Intraprocedural bleeding and nonsignificant hematochezia rates were also similar between the 2 groups (4.8% vs 2.2%, P = 0.608; 19.0% vs 8.9%, P = 0.170). No thromboembolic event occurred in either group. Only 1 patient (2.4%) in the DAPT group showed clinically significant bleeding. No significant bleeding was found in the aspirin group.
DISCUSSION


Clinically significant bleeding rate after CSP for polyps ≤10 mm in patients continuing to take DAPT was 2.4%. Therefore, CSP is a safe method for removing small polyps even in patients taking DAPT (ClincialTrials.gov number, NCT02865824).",2019,Clinically significant bleeding rate after CSP for polyps ≤10 mm in patients continuing to take DAPT was 2.4%.,"['Patients', 'Patients receiving DAPT with polyps ≤10 mm', 'patients who received colonoscopy from October 2015 to October 2016', '45 patients with 101 eligible polyps', 'Forty-two patients with 104 eligible polyps', 'patients taking dual antiplatelet therapy (DAPT']","['Taking Dual Antiplatelet Therapy', 'Thienopyridines', 'Cold Snare Polypectomy', 'Cold snare polypectomy (CSP', 'aspirin', 'DAPT group (patients continued DAPT', 'DAPT', 'CSP']","['size, location, shape, and pathology of the removed polyps', 'clinically significant bleeding', 'Intraprocedural bleeding and nonsignificant hematochezia rates', 'bleeding rate', 'thromboembolic event', 'intraprocedural bleeding, nonsignificant hematochezia, and occurrence of thromboembolic events', 'bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C1120149', 'cui_str': 'thienopyridine'}, {'cui': 'C1446340', 'cui_str': 'Cold snare'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",42.0,0.0588917,Clinically significant bleeding rate after CSP for polyps ≤10 mm in patients continuing to take DAPT was 2.4%.,"[{'ForeName': 'Dae', 'Initials': 'D', 'LastName': 'Won', 'Affiliation': ""Division of Gastroenterology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Korea.""}, {'ForeName': 'Joon Sung', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': ""Division of Gastroenterology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Korea.""}, {'ForeName': 'Jeong-Seon', 'Initials': 'JS', 'LastName': 'Ji', 'Affiliation': ""Division of Gastroenterology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Korea.""}, {'ForeName': 'Byung-Wook', 'Initials': 'BW', 'LastName': 'Kim', 'Affiliation': ""Division of Gastroenterology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Korea.""}, {'ForeName': 'Hwang', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': ""Division of Gastroenterology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Korea.""}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000091']
1378,32408868,Strategies for evaluating self-efficacy and observed success in the practice of yoga postures for therapeutic indications: methods from a yoga intervention for urinary incontinence among middle-aged and older women.,"BACKGROUND


Most clinical investigations involving yoga lack adequate description of the specific yoga elements, including physical postures. Few studies have measured self-efficacy regarding the performance of yoga postures or assessed observed success in performing postures.
METHODS


We developed and piloted several tools to evaluate self-efficacy and observed success in practicing yoga in the context of a randomized feasibility trial of an Iyengar-based yoga intervention for urinary incontinence in ambulatory women ≥50 years. At the end of the 12-week yoga intervention involving twice weekly group yoga classes and once weekly home practice, participants rated their self-efficacy in performing each of the included 15 yoga postures on a 5-point Likert scale. During the 12th week, an expert yoga consultant observed participants and rated their competency in performing postures on a 5-point scale. Participants completed a questionnaire about self-efficacy in adhering to home yoga practice. We examined the distribution of and correlations between scores on the above measures.
RESULTS


Among 27 participants (mean age 65 years), the range of means for self-efficacy ratings for individual postures was 3.6 to 4.5. The range of means for observed competency ratings for individual postures was 3.3 to 5.0. Mean self-efficacy rating for confidence in adhering to the assigned once-weekly home yoga practice was 2.8 (range 1 to 5). Posture self-efficacy was inversely correlated with participant age (p = 0.01) and positively correlated with self-reported physical function (p = 0.03) and mobility (p = 0.01). No significant correlations were found between posture self-efficacy scale scores and expert-observed yoga competency ratings or practice adherence self-efficacy scores.
CONCLUSIONS


These measures hold promise for advancing yoga research and practice by describing methods to: 1) measure self-efficacy in performing specific yoga postures; 2) use an expert observer to assess participants' competence in performing yoga postures; and 3) measure self-efficacy in adhering to home practice. These proposed measures can be used to describe specific components of yoga interventions, to assess whether study participants are able to learn to practice physical aspects of yoga and/or maintain this practice over time, as well as to investigate relationships between self-efficacy and competency in performing yoga postures to achieve specific health outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02342678, January 21, 2015.",2020,"No significant correlations were found between posture self-efficacy scale scores and expert-observed yoga competency ratings or practice adherence self-efficacy scores.
","['27 participants (mean age 65\u2009years', 'urinary incontinence among middle-aged and older women', 'ambulatory women ≥50\u2009years']","['practicing yoga', 'Iyengar-based yoga intervention', 'yoga intervention']","['Posture self-efficacy', 'physical function', 'posture self-efficacy scale scores and expert-observed yoga competency ratings or practice adherence self-efficacy scores', 'range of means for self-efficacy ratings for individual postures', 'Mean self-efficacy rating']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",,0.0380961,"No significant correlations were found between posture self-efficacy scale scores and expert-observed yoga competency ratings or practice adherence self-efficacy scores.
","[{'ForeName': 'Francesca M', 'Initials': 'FM', 'LastName': 'Nicosia', 'Affiliation': 'Division of Geriatrics and Institute for Health & Aging, University of California, San Francisco, USA. Francesca.nicosia@ucsf.edu.'}, {'ForeName': 'Nadra E', 'Initials': 'NE', 'LastName': 'Lisha', 'Affiliation': 'Center for Tobacco Control Research and Education and Division of General Internal Medicine, University of California San Francisco, 530 Parnassus, Ste 366, San Francisco, CA, 94143-1390, USA.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Chesney', 'Affiliation': 'Department of Medicine and Osher Center for Integrative Medicine, University of California San Francisco, 1545 Divisadero, San Francisco, CA, 94118, USA.'}, {'ForeName': 'Leslee L', 'Initials': 'LL', 'LastName': 'Subak', 'Affiliation': 'Department of Obstetrics and Gynecology, Stanford University School of Medicine, 300 Pasteur Drive, HG332, Office #G-303A, Stanford, California, 94305-5317, USA.'}, {'ForeName': 'Traci M', 'Initials': 'TM', 'LastName': 'Plaut', 'Affiliation': 'Division of General Internal Medicine, University of California San Francisco, Street Suite 201, Sutter, 2320, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Huang', 'Affiliation': 'Division of General Internal Medicine, University of California San Francisco, 1545 Divisadero Street, San Francisco, CA, 94118, USA.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-02934-3']
1379,32409002,A novel EML4-ALK BIRC6-ALK double fusion variant in lung adenocarcinoma confers sensitivity to alectinib.,,2020,,[],"['BIRC6-ALK', 'EML4-ALK']",[],[],"[{'cui': 'C0910612', 'cui_str': 'BIRC6 protein, human'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}]",[],,0.0427387,,"[{'ForeName': 'Jiang-Ming', 'Initials': 'JM', 'LastName': 'Zhong', 'Affiliation': 'Department of Medical Oncology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, PR China.'}, {'ForeName': 'Gui-Feng', 'Initials': 'GF', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, PR China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Oncology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, PR China.'}, {'ForeName': 'De-Yu', 'Initials': 'DY', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, PR China.'}, {'ForeName': 'Zhen-Hua', 'Initials': 'ZH', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Oncology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, PR China. Electronic address: liuzhenhua6909@163.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.04.030']
1380,31584231,Evaluation of the effect of sodium-glucose co-transporter 2 inhibition with empagliflozin on morbidity and mortality of patients with chronic heart failure and a reduced ejection fraction: rationale for and design of the EMPEROR-Reduced trial.,"Drugs that inhibit the sodium-glucose co-transporter 2 (SGLT2) have been shown to reduce the risk of hospitalizations for heart failure in patients with type 2 diabetes. In populations that largely did not have heart failure at the time of enrolment, empagliflozin, canagliflozin and dapagliflozin decreased the risk of serious new-onset heart failure events by ≈30%. In addition, in the EMPA-REG OUTCOME trial, empagliflozin reduced the risk of both pump failure and sudden deaths, the two most common modes of death among patients with heart failure. In none of the three trials could the benefits of SGLT2 inhibitors on heart failure be explained by the actions of these drugs as diuretics or anti-hyperglycaemic agents. These observations raise the possibility that SGLT2 inhibitors could reduce morbidity and mortality in patients with established heart failure, including those without diabetes. The EMPEROR-Reduced trial is enrolling ≈3600 patients with heart failure and a reduced left ventricular ejection fraction (≤ 40%), half of whom are expected not to have diabetes. Patients are being randomized to placebo or empagliflozin 10 mg daily, which is added to all appropriate treatment with inhibitors of the renin-angiotensin system and neprilysin, beta-blockers and mineralocorticoid receptor antagonists. The primary endpoint is the time-to-first event analysis of the combined risk of cardiovascular death and hospitalization for heart failure, but the trial will also evaluate the effects of empagliflozin on renal function, cardiovascular death, all-cause mortality, and recurrent hospitalization events. By adjusting eligibility based on natriuretic peptide levels to the baseline ejection fraction, the trial will preferentially enrol high-risk patients. A large proportion of the participants is expected to have an ejection fraction < 30%, and the estimated annual event rate is expected to be at least 15%. The EMPEROR-Reduced trial is well-positioned to determine if the addition of empagliflozin can add meaningfully to current approaches that have established benefits in the treatment of chronic heart failure with left ventricular systolic dysfunction.",2019,"The primary endpoint is the time-to-first event analysis of the combined risk of cardiovascular death and hospitalization for heart failure, but the trial will also evaluate the effects of empagliflozin on renal function, cardiovascular death, all-cause mortality, and recurrent hospitalization events.","['patients with established heart failure, including those without diabetes', 'patients with heart failure', 'chronic heart failure with left ventricular systolic dysfunction', '≈3600 patients with heart failure and a reduced left ventricular ejection fraction (≤\u200940%), half of whom are expected not to have diabetes', 'patients with type 2 diabetes', 'patients with chronic heart failure and a reduced ejection fraction']","['placebo or empagliflozin', 'SGLT2 inhibitors', 'empagliflozin, canagliflozin and dapagliflozin', 'sodium-glucose co-transporter 2 inhibition with empagliflozin', 'empagliflozin']","['time-to-first event analysis of the combined risk of cardiovascular death and hospitalization for heart failure', 'morbidity and mortality', 'heart failure', 'risk of both pump failure and sudden deaths', 'renal function, cardiovascular death, all-cause mortality, and recurrent hospitalization events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0749225', 'cui_str': 'Systolic dysfunction'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0011071', 'cui_str': 'Sudden death (event)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]",,0.0677547,"The primary endpoint is the time-to-first event analysis of the combined risk of cardiovascular death and hospitalization for heart failure, but the trial will also evaluate the effects of empagliflozin on renal function, cardiovascular death, all-cause mortality, and recurrent hospitalization events.","[{'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'University of Mississippi School of Medicine, Jackson, MI, USA.'}, {'ForeName': 'Gerasimos S', 'Initials': 'GS', 'LastName': 'Filippatos', 'Affiliation': 'Department of Cardiology, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Waheed', 'Initials': 'W', 'LastName': 'Jamal', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Salsali', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Schnee', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Boehringer Ingelheim Canada Ltd., Burlington, Canada.'}, {'ForeName': 'Cordula', 'Initials': 'C', 'LastName': 'Zeller', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Jyothis', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK); and Berlin Institute of Health Center for Regenerative Therapies (BCRT); German Centre for Cardiovascular Research (DZHK) partner site, Berlin, Germany, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'Inserm INI-CRCT, CHRU, Université de Lorraine, Nancy, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1536']
1381,30475306,Cardiovascular Risk Factor Reduction in First Responders Resulting From an Individualized Lifestyle and Blood Test Program: A Randomized Controlled Trial.,"OBJECTIVE


We tested the hypothesis that a lifestyle program would improve risk factors linked to cardiovascular disease (CVD) in first responders.
METHODS


A 1-year cluster-randomized controlled clinical trial in 10 cities. Participants were 175 first responders, with increased waist circumference and/or low levels of large (α1) high-density lipoprotein (HDL) particles. The intervention group received personalized online tools and access to telephonic coaching sessions.
RESULTS


At 1 year the intervention significantly reduced body weight (P = 0.004) and waist circumference (P = 0.002), increased α1 HDL (P = 0.01), and decreased triglyceride (P = 0.005) and insulin concentrations (P = 0.03). Program adherence was associated with weight loss (P = 0.0005) and increases in α1 HDL (P = 0.03).
CONCLUSIONS


In first responders, a personalized lifestyle intervention significantly improved CVD risk factors in proportion to program adherence. Changes in large HDL particles were more sensitive indicators of lifestyle changes than HDL-cholesterol measurement.
CLINICAL TRIAL REGISTRATION NUMBER


ClinicalTrials.gov: NCT03322046.",2019,"At 1 year the intervention significantly reduced body weight (P = 0.004) and waist circumference (P = 0.002), increased α1 HDL (P = 0.01), and decreased triglyceride (P = 0.005) and insulin concentrations (P = 0.03).",['10 cities'],"['personalized lifestyle intervention', 'personalized online tools and access to telephonic coaching sessions']","['risk factors linked to cardiovascular disease (CVD', 'Cardiovascular Risk Factor Reduction', 'increased α1 HDL', 'waist circumference', 'weight loss', 'insulin concentrations', 'α1 HDL', 'CVD risk factors', 'waist circumference and/or low levels of large (α1) high-density lipoprotein (HDL) particles', 'triglyceride', 'body weight']","[{'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",10.0,0.11167,"At 1 year the intervention significantly reduced body weight (P = 0.004) and waist circumference (P = 0.002), increased α1 HDL (P = 0.01), and decreased triglyceride (P = 0.005) and insulin concentrations (P = 0.03).","[{'ForeName': 'Rosalynn', 'Initials': 'R', 'LastName': 'Gill', 'Affiliation': ""Boston Heart Diagnostics, Framingham, Massachusetts (Dr Gill, Ms Jones, Ms Ghosh, Mr Gleason, Dr Dansinger); Cholesterol, Genetics, and Heart Disease Institute, Carmel, California (Dr Superko); Heart Fit for Duty, Gilbert, Arizona (Ms McCarthy, Ms Jack); Mesa Fire Services, Mesa, Arizona (Mr Richards); Children's Hospital of Oakland, Oakland (Dr Williams), California; Tufts Medical Center, Boston, Massachusetts (Dr Dansinger).""}, {'ForeName': 'Harold Robert', 'Initials': 'HR', 'LastName': 'Superko', 'Affiliation': ''}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'McCarthy', 'Affiliation': ''}, {'ForeName': 'Kepra', 'Initials': 'K', 'LastName': 'Jack', 'Affiliation': ''}, {'ForeName': 'Briana', 'Initials': 'B', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Debanjali', 'Initials': 'D', 'LastName': 'Ghosh', 'Affiliation': ''}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Richards', 'Affiliation': ''}, {'ForeName': 'Joi A', 'Initials': 'JA', 'LastName': 'Gleason', 'Affiliation': ''}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dansinger', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001490']
1382,32409111,Melatonin and melatonin agonists as treatments for benzodiazepines and hypnotics withdrawal in patients with primary insomnia. A systematic review.,"BACKGROUND


Hypnotics (HYP) and benzodiazepines (BZD) are medicines prescribed for the insomnia treatment. Many patients present difficulties in discontinuing the treatment once established. Melatonin (MLT) has been prescribed as a treatment for BZD/HYP detoxification.
AIMS


The primary objective of this systematic review is to assess the efficacy of MLT and MLT agonists (melatoninergics) in improving the rate of BZD and/or HYP discontinuation among adults with primary insomnia attempting to discontinue BZD and/or HYP. The secondary objective is to evaluate the partial efficacy of melatoninergic drugs in the discontinuation of BZD and/or HYP consumption in subjects that could not stop their consumption.
METHOD


A search on Web of Science and Scopus was carried out from database inception to July 1st, 2019.
RESULTS


Three hundred and forty-nine articles were identified but only four were included in the final review. Two were cohort prospective, one placebo-control double blind and one double blind placebo-control cross-over designed study. Total withdrawal (TW) ranged from 0% to 25% in the placebo arm and from 64.3% to 77.8% in the MLT arm. In cohort studies TW figures ranged from 30.8% to 65%. Partial withdrawal ranged between 20% and 30.8% of patients that did not achieve TW with reduction figures of diazepam equivalent dose ranging from 25% to 75%.
CONCLUSION


MLT has a place in the physician armamentarium to treat the suspension/reduction of BZD/HYP consumption in patients with primary insomnia.",2020,Total withdrawal (TW) ranged from 0% to 25% in the placebo arm and from 64.3% to 77.8% in the MLT arm.,"['patients with primary insomnia', 'Three hundred and forty-nine articles were identified but only four were included in the final review', 'adults with primary insomnia attempting to discontinue BZD and/or HYP', 'subjects that could not stop their consumption']","['MLT and MLT agonists (melatoninergics', 'placebo-control double blind and one double blind placebo-control cross', 'MLT', 'Melatonin and melatonin agonists', 'diazepam', 'Melatonin (MLT', 'benzodiazepines', 'Hypnotics (HYP) and benzodiazepines (BZD', 'placebo']","['rate of BZD and/or HYP discontinuation', 'Total withdrawal (TW', 'Partial withdrawal ranged']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033139', 'cui_str': 'Primary insomnia'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1635027', 'cui_str': 'Melatonin agonist'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",349.0,0.110412,Total withdrawal (TW) ranged from 0% to 25% in the placebo arm and from 64.3% to 77.8% in the MLT arm.,"[{'ForeName': 'Armando L', 'Initials': 'AL', 'LastName': 'Morera-Fumero', 'Affiliation': 'Departamento de Medicina Interna, Dermatología y Psiquiatría. Facultad de Ciencias de la Salud, Universidad de La Laguna, La Laguna, Santa Cruz de Tenerife, Spain; Consultoría Psiquiátrica SC, Santa Cruz de Tenerife, Spain. Electronic address: amorera@ull.edu.es.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Fernandez-Lopez', 'Affiliation': 'Departamento de Medicina Interna, Dermatología y Psiquiatría. Facultad de Ciencias de la Salud, Universidad de La Laguna, La Laguna, Santa Cruz de Tenerife, Spain; Sociedad para la Investigación y Asistencia en Salud Mental, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Abreu-Gonzalez', 'Affiliation': 'Departamento de Ciencias Médicas Básicas: Unidad de Fisiología. Facultad de Ciencias de la Salud. Universidad de la Laguna, la Laguna, Santa Cruz de Tenerife, Spain.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.107994']
1383,32409241,[Impact of antiplatelet and anticoagulant treatments on bleeding complications in patients treated with HoLEP].,"INTRODUCTION


We aimed to assess the impact of antiplatelet and anticoagulation therapy for patients undergoing HoLEP.
METHODS


We performed a study during the learning curve on a consecutive series of patients who underwent HoLEP surgery from 2015 to 2018. The patients were divided into 3 groups: a control group, patients with antiplatelet therapy and patients with anticoagulation therapy.
RESULTS


A total of 223 patients underwent HoLEP surgery during this period: 124 in the control group, 63 in the antiplatelet group and 36 in the anticoagulant group. In the anticoagulant group, we observe significant differences with the control group for the catheterization time (2.05 days vs 5.17 days; P<0.001), the hospital length of stay (1.5 nights vs 4.49 nights; P<0.001) and complications (8.9% vs 58%; P<0.001). No difference between the control and antiplatelet groups in terms of catheterization time, hospital length of stay and complications (2.05 days vs 2.68 days; 1.5 nights vs 1.6 nights) but variation in terms of complications and bleeding complications (8.9% vs 21%; P<0,001; 8.1% vs 19%; P<0,001) CONCLUSION: Our study shows that HoLEP is therefore associated with a higher risk of bleeding for patients treated with anticoagulation therapy. Complications increase morbidity with longer catheterization time, hospitalization times and higher transfusion's rates, revision surgery and readmission.
LEVEL OF EVIDENCE


3.",2020,"No difference between the control and antiplatelet groups in terms of catheterization time, hospital length of stay and complications (2.05 days vs 2.68 days; 1.5 nights vs 1.6 nights) but variation in terms of complications and bleeding complications (8.9% vs 21%; P<0,001; 8.1% vs 19%; P<0,001) CONCLUSION:","['patients who underwent HoLEP surgery from 2015 to 2018', 'patients treated with HoLEP', '223 patients underwent HoLEP surgery during this period: 124 in the control group, 63 in the antiplatelet group and 36 in the anticoagulant group', 'patients undergoing HoLEP']","['antiplatelet and anticoagulation therapy', 'HoLEP', 'antiplatelet and anticoagulant treatments', 'anticoagulation therapy', 'antiplatelet therapy']","['hospital length of stay', 'catheterization time', 'complications and bleeding complications', 'bleeding complications', 'catheterization time, hospital length of stay and complications', ""Complications increase morbidity with longer catheterization time, hospitalization times and higher transfusion's rates, revision surgery and readmission"", 'risk of bleeding', 'complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",223.0,0.0434497,"No difference between the control and antiplatelet groups in terms of catheterization time, hospital length of stay and complications (2.05 days vs 2.68 days; 1.5 nights vs 1.6 nights) but variation in terms of complications and bleeding complications (8.9% vs 21%; P<0,001; 8.1% vs 19%; P<0,001) CONCLUSION:","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Branchu', 'Affiliation': ""Service d'urologie, CHU de Reims, rue Cognacq-Jay, 51100 Reims, France. Electronic address: bbranchu@chu-reims.fr.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Léon', 'Affiliation': ""Service d'urologie, clinique Pasteur, 17200 Royan, France.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Fournier', 'Affiliation': ""Service d'urologie, CHU de Reims, rue Cognacq-Jay, 51100 Reims, France.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lasserre', 'Affiliation': ""Service d'urologie, CHU de Reims, rue Cognacq-Jay, 51100 Reims, France.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Tambwe', 'Affiliation': ""Service d'urologie, CHU de Reims, rue Cognacq-Jay, 51100 Reims, France.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hoquetis', 'Affiliation': ""Service d'urologie, CHU de Reims, rue Cognacq-Jay, 51100 Reims, France.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Joncour', 'Affiliation': ""Service d'urologie, CHU de Reims, rue Cognacq-Jay, 51100 Reims, France.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Larré', 'Affiliation': ""Service d'urologie, CHU de Reims, rue Cognacq-Jay, 51100 Reims, France.""}]",Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise d'urologie,['10.1016/j.purol.2020.04.018']
1384,31652109,Cold-Water Immersion Does Not Accelerate Performance Recovery After 10-km Street Run: Randomized Controlled Clinical Trial.,"The use of strategies to assure better post-effort recovery is frequent in sports settings. There are several interventions available for exercise induced muscle damage recovery, but cold-water immersion (CWI) stands out among them. The effects of CWI are unclear in the literature and, although the number of street runners has been growing, there is a gap in the scientific evidence regarding the use of CWI to recover runners' performance after a 10-km street run.  Purpose:  The goal of our study was to analyze the effects of CWI on the recovery of muscle damage markers after a 10-km street run.  Method:  We randomly assigned thirty male recreational street runners, immediately after a 10-km street run, into three recovery groups: control (rest for 10 minutes), immersion (10 min immersed in water without ice at room temperature) and CWI (10 min immersed in water with ice at 10ºC). We assessed pain, triple hop distance, extensor peak torque and blood creatine kinase levels pre- and post-run, post-intervention and 24 hours after the run.  Results:  The 10-km run was enough to decrease triple hop distance and extensor peak torque, and increase levels of creatine kinase ( p  < 0.05); however, we found no time/group interactions in any of the assessed variables after we applied the appropriate interventions ( p  > 0.05).  Conclusion:  10-min CWI at 10°C was no more effective than water immersion and rest in recovering muscle damage markers after 10-km runs.",2020,"The 10-km run was enough to decrease triple hop distance and extensor peak torque, and increase levels of creatine kinase ( p  < 0.05); however, we found no time/group interactions in any of the assessed variables after we applied the appropriate interventions ( p  > 0.05).  ","['thirty male recreational street runners, immediately after a 10-km street run, into three recovery groups']","['Cold-water Immersion', 'control (rest for 10 minutes), immersion (10 min immersed in water without ice at room temperature) and CWI', 'CWI']","['pain, triple hop distance, extensor peak torque and blood creatine kinase levels pre- and post-run, post-intervention and 24 hours after the run', 'triple hop distance and extensor peak torque, and increase levels of creatine kinase']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0442658', 'cui_str': 'Street (environment)'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C4708833', 'cui_str': 'Cold water'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0349714', 'cui_str': 'Icing (substance)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C4018995', 'cui_str': 'Hop'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0853178', 'cui_str': 'Blood creatine'}, {'cui': 'C4521566', 'cui_str': 'Kinase'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}]",30.0,0.0695893,"The 10-km run was enough to decrease triple hop distance and extensor peak torque, and increase levels of creatine kinase ( p  < 0.05); however, we found no time/group interactions in any of the assessed variables after we applied the appropriate interventions ( p  > 0.05).  ","[{'ForeName': 'Glauko', 'Initials': 'G', 'LastName': 'Dantas', 'Affiliation': 'Federal University of São Carlos.'}, {'ForeName': 'Alef', 'Initials': 'A', 'LastName': 'Barros', 'Affiliation': 'Federal University of Rio Grande do Norte.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Silva', 'Affiliation': 'Federal University of Rio Grande do Norte.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Belém', 'Affiliation': 'Federal University of Rio Grande do Norte.'}, {'ForeName': 'Vitoria', 'Initials': 'V', 'LastName': 'Ferreira', 'Affiliation': 'Federal University of Rio Grande do Norte.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Fonseca', 'Affiliation': 'Federal University of Rio Grande do Norte.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Castro', 'Affiliation': 'Federal University of Rio Grande do Norte.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Santos', 'Affiliation': 'Federal University of Rio Grande do Norte.'}, {'ForeName': 'Telma', 'Initials': 'T', 'LastName': 'Lemos', 'Affiliation': 'Federal University of Rio Grande do Norte.'}, {'ForeName': 'Wouber', 'Initials': 'W', 'LastName': 'Hérickson', 'Affiliation': 'Federal University of Rio Grande do Norte.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2019.1659477']
1385,31648203,Effects of a 12-Week Chronic Stretch Training Program at Different Intensities on Joint and Muscle Mechanical Responses: A Randomized Clinical Trial.,"CONTEXT


Stretching intensity is an important variable that can be manipulated with flexibility training. However, there is a lack of evidence regarding this variable and its prescription in stretching programs.
OBJECTIVE


To investigate the effects of 12 weeks of knee flexor static stretching at different intensities on joint and muscle mechanical properties.
DESIGN


A randomized clinical trial.
SETTING


Laboratory.
PARTICIPANTS


A total of 14 untrained men were allocated into the low- or high-intensity group.
MAIN OUTCOME MEASURES


Assessments were performed before, at 6 week, and after intervention (12 wk) for biceps femoris long head architecture (resting fascicle length and angle), knee maximal range of motion (ROM) at the beginning and maximal discomfort angle, knee maximal tolerated passive torque, joint passive stiffness, viscoelastic stress relaxation, knee passive torque at a given angle, and affective responses to training.
RESULTS


No significant differences were observed between groups for any variable. ROM at the beginning and maximal discomfort angle increased at 6 and 12 weeks, respectively. ROM significantly increased with the initial angle of discomfort (P < .001, effect size = 1.38) over the pretest measures by 13.4% and 14.6% at the 6- and 12-week assessments, respectively, and significantly improved with the maximal discomfort angle (P < .001, effect size = 1.25) by 15.6% and 18.8% from the pretest to the 6- and 12-week assessments, respectively. No significant effects were seen for muscle architecture and affective responses. Initial viscoelastic relaxation for the low-intensity group was lower than ending viscoelastic relaxation.
CONCLUSION


These results suggest that stretching with either low or high discomfort intensities are effective in increasing joint maximal ROM, and that does not impact on ROM, stiffness, fascicle angle and length, or affective response differences.",2019,"ROM significantly increased with the initial angle of discomfort (P < .001, effect size = 1.38) over the pretest measures by 13.4% and 14.6% at the 6- and 12-week assessments, respectively, and significantly improved with the maximal discomfort angle (P < .001, effect size = 1.25) by 15.6% and 18.8% from the pretest to the 6- and 12-week assessments, respectively.",['A total of 14 untrained men'],"['low- or high-intensity group', '12-Week Chronic Stretch Training Program', 'knee flexor static stretching']","['muscle architecture and affective responses', 'Initial viscoelastic relaxation', 'Joint and Muscle Mechanical Responses', 'biceps femoris long head architecture (resting fascicle length and angle), knee maximal range of motion (ROM) at the beginning and maximal discomfort angle, knee maximal tolerated passive torque, joint passive stiffness, viscoelastic stress relaxation, knee passive torque at a given angle, and affective responses to training', 'ROM', 'initial angle of discomfort', 'ROM, stiffness, fascicle angle and length, or affective response differences', 'maximal discomfort angle']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",,0.0246937,"ROM significantly increased with the initial angle of discomfort (P < .001, effect size = 1.38) over the pretest measures by 13.4% and 14.6% at the 6- and 12-week assessments, respectively, and significantly improved with the maximal discomfort angle (P < .001, effect size = 1.25) by 15.6% and 18.8% from the pretest to the 6- and 12-week assessments, respectively.","[{'ForeName': 'Natália Barros', 'Initials': 'NB', 'LastName': 'Beltrão', 'Affiliation': ''}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Ximenes Santos', 'Affiliation': ''}, {'ForeName': 'Valéria Mayaly Alves', 'Initials': 'VMA', 'LastName': 'de Oliveira', 'Affiliation': ''}, {'ForeName': 'André Luiz Torres', 'Initials': 'ALT', 'LastName': 'Pirauá', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Behm', 'Affiliation': ''}, {'ForeName': 'Ana Carolina Rodarti', 'Initials': 'ACR', 'LastName': 'Pitangui', 'Affiliation': ''}, {'ForeName': 'Rodrigo Cappato', 'Initials': 'RC', 'LastName': 'de Araújo', 'Affiliation': ''}]",Journal of sport rehabilitation,['10.1123/jsr.2018-0443']
1386,30142023,Sleep facilitates consolidation of positive emotional memory in healthy older adults.,"Evidence has demonstrated that sleep-related memory consolidation declines in ageing. However, little is known about age-related changes to sleep-related emotional memory consolidation, especially when considering the positivity effect observed in older adults. In the present study, we sought to explore whether there is a positive emotional bias in sleep-related memory consolidation among healthy older adults. Young and older adults were randomly assigned either into a sleep or wake condition. All participants encoded positive, negative, and neutral stimuli and underwent recognition tests immediately ( test 1 ), after a 12-hour sleep/wake interval ( test 2 ), and 3 days after test 2 ( test 3 ). Results showed that age-related differences of sleep beneficial effect were modulated by emotion valence. In particular, sleep selectively enhanced positive memory in older adults, while in young adults sleep beneficial effect was manifested in neutral memory. Moreover, the sleep beneficial effect can be maintained at least 3 days in both young and older adults. These findings suggest that older adults had preserved but positive bias of sleep-related memory consolidation, which could be one of the underlying mechanisms for their generally better emotional well-being in daily life. These findings highlight the dynamic interplay among sleep and emotional memory in older adults.",2019,"In particular, sleep selectively enhanced positive memory in older adults, while in young adults sleep beneficial effect was manifested in neutral memory.","['young and older adults', 'healthy older adults', 'Young and older adults', 'older adults']",[],['sleep beneficial effect'],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.0396723,"In particular, sleep selectively enhanced positive memory in older adults, while in young adults sleep beneficial effect was manifested in neutral memory.","[{'ForeName': 'Wen-Jun', 'Initials': 'WJ', 'LastName': 'Gui', 'Affiliation': ""a Faculty of Psychology , Southwest University , Chongqing 400715 , People's Republic of China.""}, {'ForeName': 'Peng-Yun', 'Initials': 'PY', 'LastName': 'Wang', 'Affiliation': ""b Key Laboratory of Mental Health , Institute of Psychology, Chinese Academy of Sciences , Beijing 100101 , People's Republic of China.""}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': ""a Faculty of Psychology , Southwest University , Chongqing 400715 , People's Republic of China.""}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'c Department of Psychology , University of Florida , Gainesville , FL 32611-2250 , USA.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Horta', 'Affiliation': 'c Department of Psychology , University of Florida , Gainesville , FL 32611-2250 , USA.'}, {'ForeName': 'Xiao-Yi', 'Initials': 'XY', 'LastName': 'Liu', 'Affiliation': ""a Faculty of Psychology , Southwest University , Chongqing 400715 , People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': ""a Faculty of Psychology , Southwest University , Chongqing 400715 , People's Republic of China.""}]","Memory (Hove, England)",['10.1080/09658211.2018.1513038']
1387,31609926,Brief Report: Zinc Supplementation and Inflammation in Treated HIV.,"OBJECTIVE


In this study, we explored the effect of zinc supplementation on markers of inflammation and monocyte activation in antiretroviral therapy-treated HIV infection.
METHODS


This is a phase I open-labeled randomized double-arm study, exploring the efficacy and safety of zinc supplementation on inflammation in ≥18-year-old people living with HIV in the US, on stable antiretroviral therapy and with zinc levels ≤75 µg/dL in the last 60 days. Patients were randomized 1:1 to zinc gluconate capsules at a dose of 45 mg (low-dose), or 90 mg (high-dose) elemental zinc daily for 16 weeks. We assessed inflammatory and gut integrity biomarkers at baseline and 16 weeks.
RESULTS


Overall, a total of 52 participants were enrolled (25 participants in the low-dose arm and 27 participants in the high-dose arm). Median (Interquartile range) age was 49 (38, 60) years, 77% were men and 73% were African Americans. At baseline, median zinc levels were 73 (64, 86) µg/dL. Median circulating zinc levels increased to 91 µg/dL in the low-dose arm and to 100 µg/dL in the high-dose arm. Overall, 48%-60% of participants experienced a reduction in biomarkers levels. The margin of reduction ranged between 8% and 21%. This change was meaningful with large effect size (Cohen D ranging from 5 to 19).
CONCLUSIONS


In this pilot study, we found that zinc supplementation is effective at increasing circulating zinc levels. In addition, our findings provide novel data suggesting that zinc can affect a biological signature in people living with HIV and modulate biomarkers associated with clinical comorbidities.",2019,"At baseline, median zinc levels were 73 (64, 86) µg/dL. Median circulating zinc levels increased to 91 µg/dL in the low-dose arm and to 100 µg/dL in the high-dose arm.","['52 participants were enrolled (25 participants in the low-dose arm and 27 participants in the high-dose arm', '≥18-year-old people living with HIV in the US, on stable antiretroviral therapy and with zinc levels ≤75 µg/dL in the last 60 days', 'Median (Interquartile range) age was 49 (38, 60) years, 77% were men and 73% were African Americans', 'Treated HIV']","['zinc gluconate capsules', 'zinc supplementation']","['circulating zinc levels', 'median zinc levels', 'biomarkers levels', 'markers of inflammation and monocyte activation', 'Median circulating zinc levels', 'inflammatory and gut integrity biomarkers']","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0373748', 'cui_str': 'Zinc measurement (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0647859', 'cui_str': 'AM49'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0149381', 'cui_str': 'Zinc Gluconate'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0373748', 'cui_str': 'Zinc measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}]",52.0,0.524287,"At baseline, median zinc levels were 73 (64, 86) µg/dL. Median circulating zinc levels increased to 91 µg/dL in the low-dose arm and to 100 µg/dL in the high-dose arm.","[{'ForeName': 'Sahera', 'Initials': 'S', 'LastName': 'Dirajlal-Fargo', 'Affiliation': ""Department of Pediatrics, Division of Pediatric Infectious Diseases, Rainbow Babies and Children's Hospital, Cleveland, OH.""}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Manjusha', 'Initials': 'M', 'LastName': 'Kulkarni', 'Affiliation': 'Division of Medical Laboratory Science, Ohio State University School of Health and Rehabilitation Sciences, Columbus, OH.'}, {'ForeName': 'Abdus', 'Initials': 'A', 'LastName': 'Sattar', 'Affiliation': 'Department of Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Funderburg', 'Affiliation': 'Division of Medical Laboratory Science, Ohio State University School of Health and Rehabilitation Sciences, Columbus, OH.'}, {'ForeName': 'Hope', 'Initials': 'H', 'LastName': 'Barkoukis', 'Affiliation': 'Department of Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Grace A', 'Initials': 'GA', 'LastName': 'Mccomsey', 'Affiliation': ""Department of Pediatrics, Division of Pediatric Infectious Diseases, Rainbow Babies and Children's Hospital, Cleveland, OH.""}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002129']
1388,31504572,Reduction of inappropriate medication in older populations by electronic decision support (the PRIMA-eDS project): a survey of general practitioners' experiences.,"OBJECTIVE


We sought to investigate the experiences of general practitioners (GPs) with an electronic decision support tool to reduce inappropriate polypharmacy in older patients (the PRIMA-eDS [Polypharmacy in chronic diseases: Reduction of Inappropriate Medication and Adverse drug events in older populations by electronic Decision Support] tool) in a multinational sample of GPs and to quantify the findings from a prior qualitative study on the PRIMA-eDS-tool.
MATERIALS AND METHODS


Alongside the cluster randomized controlled PRIMA-eDS trial, a survey was conducted in all 5 participating study centers (Bolzano, Italy; Manchester, United Kingdom; Salzburg, Austria; Rostock, Germany; and Witten, Germany) between October 2016 and July 2017. Data were analyzed using descriptive statistics and chi-square tests.
RESULTS


Ninety-one (n = 160) percent of the 176 questionnaires were returned. Thirty-two percent of the respondents reported that they did not cease drugs because of the medication check. The 68% who had discontinued drugs comprise 57% who had stopped on average 1 drug and 11% who had stopped 2 drugs or more per patient. The PRIMA-eDS tool was found to be useful (69%) and the recommendations were found to help to increase awareness (86%). The greatest barrier to implementing deprescribing recommendations was the perceived necessity of the medication (69%). The majority of respondents (65%) would use the electronic medication check in routine practice if it was part of the electronic health record.
CONCLUSIONS


GPs generally viewed the PRIMA-eDS medication check as useful and as informative. Recommendations were not always followed due to various reasons. Many GPs would use the medication check if integrated into the electronic health record.",2019,The PRIMA-eDS tool was found to be useful (69%) and the recommendations were found to help to increase awareness (86%).,"['all 5 participating study centers (Bolzano, Italy; Manchester, United Kingdom; Salzburg, Austria; Rostock, Germany; and Witten, Germany) between October 2016 and July 2017', 'The 68% who had discontinued drugs comprise 57% who had stopped on average 1 drug and 11% who had stopped 2 drugs or more per patient', 'Ninety-one (n\u2009=\u2009160) percent of the 176 questionnaires were returned', 'older patients (the PRIMA-eDS [Polypharmacy in chronic diseases']",['general practitioners (GPs) with an electronic decision support tool'],[],"[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2922974', 'cui_str': 'Polymedication'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}]","[{'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}]",[],,0.0298842,The PRIMA-eDS tool was found to be useful (69%) and the recommendations were found to help to increase awareness (86%).,"[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Rieckert', 'Affiliation': 'Department of Human Medicine, Institute of General Practice and Family Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Anne-Lisa', 'Initials': 'AL', 'LastName': 'Teichmann', 'Affiliation': 'Department of Human Medicine, Institute of General Practice and Family Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Drewelow', 'Affiliation': 'Institute of General Practice, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Kriechmayr', 'Affiliation': 'Institute of General Practice, Family Medicine and Preventive Medicine, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Giuliano', 'Initials': 'G', 'LastName': 'Piccoliori', 'Affiliation': 'South Tyrolean Academy for General Practice, Bolzano, Italy.'}, {'ForeName': 'Adrine', 'Initials': 'A', 'LastName': 'Woodham', 'Affiliation': 'Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Sönnichsen', 'Affiliation': 'Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, University of Manchester, Manchester, United Kingdom.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocz104']
1389,31686430,A relatively higher intraocular pressure set at the end of vitrectomy is associated with a more stable and rapid visual recovery for patients with vitreous haemorrhage.,"PURPOSE


To compare structural and functional improvements in patients with vitreous haemorrhage (VH) with different IOPs re-established at the end of pars plana vitrectomy (PPV).
METHODS


It is a prospective, randomized, comparative, interventional study. Ninety-five patients with nonclearing VH were randomized to receive PPV with normalized IOPs of 15 mmHg (Group I: 32 eyes), 25 mmHg (Group II: 32 eyes) and 35 mmHg (Group III: 31 eyes) at the end of surgery. The grade of vitreous opacity and best-corrected visual acuity (BCVA) on postoperative day 1, week 1, month 1 and month 3 were compared with a mixed model for repeated measures analysis.
RESULTS


All 3 groups achieved significant improvement on postoperatively in BCVA (p < 0.01) and vitreous opacity (p < 0.01) compared with the baseline. The group difference was significant at the end of week 1 and showed a trend of higher IOP set at the end of PPV with better anatomical (p < 0.01) and visual recovery (p < 0.01). However, at postoperative month 1 and month 3, equivalent anatomical (month 1: p = 0.56; month 3: p = 0.36) and visual outcomes (month 1: p = 0.16; month 3: p = 0.88) were obtained in the 3 groups. The average effect of IOP on BCVA (group II versus group III: effect size (ES): 0.41, p < 0.01; group I versus group III: ES: 0.66, p < 0.01) and vitreous opacity (group II versus group III: ES: 0.70, p < 0.01; group I versus group III: ES:1.09, p < 0.01) over the course of the study period was statistically significant. The only postoperative complication was recurrent VH in two patients allocating in group I and II, respectively.
CONCLUSIONS


A relatively higher IOP set at the end of vitrectomy resulted in a more stable and rapid recovery with fewer complications in patients with non-complex VH.",2020,All 3 groups achieved significant improvement on postoperatively in BCVA (p < 0.01) and vitreous opacity (p < 0.01) compared with the baseline.,"['patients with vitreous haemorrhage (VH) with different IOPs re-established at the end of pars plana vitrectomy (PPV', 'patients with vitreous haemorrhage', 'Ninety-five patients with nonclearing VH']",['PPV with normalized IOPs of 15\xa0mmHg'],"['visual outcomes', 'visual recovery', 'vitreous opacity', 'grade of vitreous opacity and best-corrected visual acuity (BCVA', 'postoperative complication', 'higher IOP set', 'BCVA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042909', 'cui_str': 'Vitreous Hemorrhage'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C4517906', 'cui_str': '95'}]","[{'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0152006', 'cui_str': 'Vitreous opacities (disorder)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}]",95.0,0.028175,All 3 groups achieved significant improvement on postoperatively in BCVA (p < 0.01) and vitreous opacity (p < 0.01) compared with the baseline.,"[{'ForeName': 'Chuandi', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Department of Ophthalmology, Shanghai General Hospital, Shanghai Key Laboratory of Ocular Fundus Diseases, Shanghai Engineering Center for Visual Science and Photomedicine, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Ophthalmology, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Luo', 'Affiliation': 'Department of Ophthalmology, Shanghai General Hospital, Shanghai Key Laboratory of Ocular Fundus Diseases, Shanghai Engineering Center for Visual Science and Photomedicine, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Chufeng', 'Initials': 'C', 'LastName': 'Gu', 'Affiliation': 'Department of Ophthalmology, Shanghai General Hospital, Shanghai Key Laboratory of Ocular Fundus Diseases, Shanghai Engineering Center for Visual Science and Photomedicine, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Tashi', 'Initials': 'T', 'LastName': 'Lahm', 'Affiliation': ""Department of Ophthalmology, Shigatse People's Hospital, Shanghai, China.""}, {'ForeName': 'Deji', 'Initials': 'D', 'LastName': 'Draga', 'Affiliation': ""Department of Ophthalmology, Shigatse People's Hospital, Shanghai, China.""}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Qiu', 'Affiliation': 'Department of Ophthalmology, Shanghai General Hospital, Shanghai Key Laboratory of Ocular Fundus Diseases, Shanghai Engineering Center for Visual Science and Photomedicine, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}]",Acta ophthalmologica,['10.1111/aos.14293']
1390,31261247,Evaluation of a Novel Educational Tool in Adolescents With Inflammatory Bowel Disease: The NEAT Study.,"OBJECTIVES


Among adolescents with inflammatory bowel disease (IBD), nonadherence rates are 50 to 88% across medications. Improving education in adults with IBD has been shown to improve coping and adherence to treatment in adults with IBD. Therapeutic patient education (TPE) has been used in patients with chronic diseases to train patients in skills to support treatment adaptation and condition management. This study tested the feasibility and preliminary efficacy of a novel TPE intervention in adolescents with IBD.
METHODS


In this pilot, mixed-methods study, we evaluated the feasibility and preliminary efficacy of TPE with the IBD Pocket Guide on medication adherence, IBD knowledge, and transition readiness in adolescents ages 11 to 18 years. Medication adherence was monitored using a MedMinder Pill Dispensing system. Participants who were <90% adherent during a 4-week pre-intervention monitoring period were randomized to either a usual care group or an educational intervention (EI) group. Participants were followed for an additional 4 weeks after intervention.
RESULTS


Trends were found in the EI group indicating improved medication adherence and IBD knowledge compared with the usual care group, though differences between groups did not reach statistical significance. Qualitative data showed that participants perceived that they had improved knowledge after the educational intervention.
CONCLUSIONS


Therapeutic patient education may be beneficial for improving patient medication adherence and IBD knowledge. Future directions include testing the effects of the intervention with a larger sample.",2019,"RESULTS


Trends were found in the EI group indicating improved medication adherence and IBD knowledge compared to the usual care group, though differences between groups did not reach statistical significance.","['adults with IBD', 'Participants who were <90% adherent during a 4 week pre-intervention monitoring period', 'patients with chronic diseases to train patients', 'adolescents aged 11-18 years', 'adolescents with IBD', 'adolescents with Inflammatory Bowel Disease (IBD', 'Adolescents with Inflammatory Bowel Disease']","['usual care group or an educational intervention (EI) group', 'novel TPE intervention', 'Therapeutic patient education (TPE', 'TPE', 'Novel Educational Tool']","['medication adherence and IBD knowledge', 'medication adherence, IBD knowledge and transition readiness', 'Medication adherence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0439087', 'cui_str': '<90 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}]",,0.0332146,"RESULTS


Trends were found in the EI group indicating improved medication adherence and IBD knowledge compared to the usual care group, though differences between groups did not reach statistical significance.","[{'ForeName': 'Karla K H', 'Initials': 'KKH', 'LastName': 'Vaz', 'Affiliation': ""Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Cincinnati Children's Hospital Medical Center, Schubert-Martin Inflammatory Bowel Disease Center.""}, {'ForeName': 'Julia K', 'Initials': 'JK', 'LastName': 'Carmody', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Bioinformatics and Biostatistics, School of Life Sciences and Biotechnology, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Lee A', 'Initials': 'LA', 'LastName': 'Denson', 'Affiliation': ""Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Cincinnati Children's Hospital Medical Center, Schubert-Martin Inflammatory Bowel Disease Center.""}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Hommel', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002431']
1391,31356580,Therapeutic Hypothermia in Organ Donors: Follow-up and Safety Analysis.,"BACKGROUND


In a recent trial, targeted mild hypothermia in brain-dead organ donors significantly reduced the incidence of delayed graft function after kidney transplantation. This trial was stopped early for efficacy. Here, we report long-term graft survival for all organs along with donor critical care end points.
METHODS


We assessed graft survival through 1 year of all solid organs transplanted from 370 donors who had been randomly assigned to hypothermia (34-35°C) or normothermia (36.5-37.5°C) before donation. Additionally, changes in standardized critical care end points were compared between donors in each group.
RESULTS


Mild hypothermia was associated with a nonsignificant improvement in 1-year kidney transplant survival (95% versus 92%; hazard ratio, 0.61 [0.31-1.20]; P = 0.15). Mild hypothermia was associated with higher 1-year graft survival in the subgroup of standard criteria donors (97% versus 93%; hazard ratio, 0.39 [0.15 to -1.00]; P = 0.05). There were no significant differences in graft survival of extrarenal organs. There were no differences in critical care end points between groups.
CONCLUSIONS


Mild hypothermia in the donor safely reduced the rate of delayed graft function in kidney transplant recipients without adversely affecting donor physiology or extrarenal graft survival. Kidneys from standard criteria donors who received targeted mild hypothermia had improved 1-year graft survival.",2019,"Mild hypothermia was associated with a nonsignificant improvement in one-year kidney transplant survival (95% vs. 92%, hazards ratio [HR]",['370 donors who had been randomly assigned to hypothermia (34-35°C) or normothermia (36.5-37.5°C) prior to donation'],[],"['Mild hypothermia', 'year graft survival', 'graft survival of extra-renal organs', 'hazards ratio [HR', 'year kidney transplant survival', 'rate of DGF', 'graft survival']","[{'cui': 'C4517743', 'cui_str': 'Three hundred and seventy'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0445103', 'cui_str': 'Normothermia (qualifier value)'}, {'cui': 'C4517742', 'cui_str': '37.5 (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C4049936', 'cui_str': 'Donation'}]",[],"[{'cui': 'C0445043', 'cui_str': 'Mild hypothermia (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.288728,"Mild hypothermia was associated with a nonsignificant improvement in one-year kidney transplant survival (95% vs. 92%, hazards ratio [HR]","[{'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Malinoski', 'Affiliation': 'Section of Surgical Critical Care, VA Portland Healthcare System, Portland, OR.'}, {'ForeName': 'Madhukar S', 'Initials': 'MS', 'LastName': 'Patel', 'Affiliation': 'Department of Surgery, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Axelrod', 'Affiliation': 'University of Iowa Transplant Institute, Iowa City, IA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Broglio', 'Affiliation': 'Berry Consultants, LLC, Austin, TX.'}, {'ForeName': 'Roger J', 'Initials': 'RJ', 'LastName': 'Lewis', 'Affiliation': 'Berry Consultants, LLC, Austin, TX.'}, {'ForeName': 'Tahnee', 'Initials': 'T', 'LastName': 'Groat', 'Affiliation': 'Section of Surgical Critical Care, VA Portland Healthcare System, Portland, OR.'}, {'ForeName': 'Claus U', 'Initials': 'CU', 'LastName': 'Niemann', 'Affiliation': 'Department of Anesthesia and Perioperative Care, University of California San Francisco, San Francisco, CA.'}]",Transplantation,['10.1097/TP.0000000000002890']
1392,31647384,Long-Term Effects in the EXERDIET-HTA Study: Supervised Exercise Training  vs . Physical Activity Advice.,"Purpose : To determine whether improvements in cardiorespiratory fitness (CRF), blood pressure (BP) and body composition previously seen after a 16-week exercise intervention (POST) with hypocaloric diet are maintained following six months (6M) of unsupervised exercise time.  Methods : Overweight/obese, physically inactive participants with primary hypertension (HTN) (n = 190) were randomly assigned into an attention control group (physical activity recommendations) or one of three supervised exercise groups. After POST, all participants received diet and physical activity advice for the following 6M but no supervision. All anthropometric and physiological measurements were taken pre and post the 16-week supervised intervention period, as well as after 6M of no supervision.  Results : After 6M: 1) body mass (BM) (Δ = 2.5%) and waist circumference (Δ = 1.8%) were higher ( P  < .005) than POST, but lower ( P  < .005) than pre-intervention (BM, Δ = -5.1%; waist circumference, Δ = -4.7%), with high-volume and high-intensity interval training group revealing a higher BM reduction (Δ = -6.4 kg) compared to control group (Δ = -3.5 kg); 2) BP variables were higher ( P  < .001) compared to POST with no change from pre-intervention; and 3) CRF was higher compared to pre-intervention (Δ = 17.1%,  P  < .001) but lower than POST (Δ = -5.7%,  P  < .001).  Conclusions : When an overweight/obese population with HTN attains significant improvements in cardiometabolic health POST intervention with diet restriction, there is a significant reduction following 6M when exercise and diet supervision is removed, and only recommendations were applied. These results suggest the need for a regular, systematic and supervised diet and exercise programs to avoid subsequent declines in cardiometabolic health.",2020,"P  < .001) compared to POST with no change from pre-intervention; and 3) CRF was higher compared to pre-intervention (Δ = 17.1%,  P  < .001) but lower than POST (","['Overweight/obese, physically inactive participants with primary hypertension (HTN) (n = 190']","['attention control group (physical activity recommendations) or one of three supervised exercise groups', 'Supervised Exercise Training  vs ', 'exercise intervention (POST) with hypocaloric diet']","['BM reduction', 'waist circumference', 'Physical Activity Advice', 'cardiorespiratory fitness (CRF), blood pressure (BP) and body composition']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}]",,0.0224371,"P  < .001) compared to POST with no change from pre-intervention; and 3) CRF was higher compared to pre-intervention (Δ = 17.1%,  P  < .001) but lower than POST (","[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Corres', 'Affiliation': 'University of the Basque Country (UPV/EHU).'}, {'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'MartinezAguirre-Betolaza', 'Affiliation': 'University of the Basque Country (UPV/EHU).'}, {'ForeName': 'Simon M', 'Initials': 'SM', 'LastName': 'Fryer', 'Affiliation': 'University of Gloucestershire.'}, {'ForeName': 'Ilargi', 'Initials': 'I', 'LastName': 'Gorostegi-Anduaga', 'Affiliation': 'University of the Basque Country (UPV/EHU).'}, {'ForeName': 'Iñaki', 'Initials': 'I', 'LastName': 'Arratibel-Imaz', 'Affiliation': 'University of the Basque Country (UPV/EHU).'}, {'ForeName': 'G Rodrigo', 'Initials': 'GR', 'LastName': 'Aispuru', 'Affiliation': 'Igualatorio Médico Quirúrgico (IMQ-Amárica).'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Maldonado-Martín', 'Affiliation': 'University of the Basque Country (UPV/EHU).'}]",Research quarterly for exercise and sport,['10.1080/02701367.2019.1656794']
1393,32409277,Community perspectives on difference of sex development (DSD) diagnoses: A crowdsourced survey.,"INTRODUCTION AND OBJECTIVES


Differences of sex development (DSD) engender ethical, social and psychosexual complexities that can complicate medical decision-making. We performed a web-based pilot study to estimate the utility value of a DSD diagnosis and to identify community concerns regarding DSD management.
METHODS


A cross-sectional survey was posted on Amazon's Mechanical Turk, an online crowdsourcing platform. Respondents were ≥18y and were randomized to receive information on one of three common DSD conditions: Congenital Adrenal Hyperplasia (CAH), Mixed Gonadal Dysgenesis (MGD), and Partial Androgen Insensitivity Syndrome (PAIS). Time trade-off methodology was used to estimate utility values. Likert scale and statement-ranking questions were used to assess respondent perceptions.
RESULTS


Of 1,628 respondents, median age was 34y; most respondents were parents (59.1%), white (77.1%), and previously unfamiliar with DSD (60.4%). The median overall utility value was 0.70 (IQR 0.50-0.90), similar to moderately severe chronic health conditions. Utility estimates varied based on the DSD scenario presented (0.80 CAH vs. 0.70 MGD vs. 0.80 PAIS, p = 0.0006), respondent gender (p < 0.0001), race (p = 0.002), religion (p = 0.005), and prior knowledge of DSD (p < 0.0001). Reported concerns included gender identity (23.4%), urinary function (20.5%) and surgical complications (17.4%). Most (67.5%) supported early surgical intervention at 6-18 mo; 10.4% thought surgery should occur ≥18 y.
COMMENT


Limitations of this study include that survey participants were aware of the nature of the study, thus some respondents may have participated to skew the results. Given the nature of this pilot study, the representation of families with children with DSD within the study is severely limited given the rarity of DSDs. This means that their opinions may be diluted by the large sample size. However, because utility values are classically estimated according to community opinions, the utility data presented should be taken to reflect that of the specific sample studied and is not reflective of that of families with a vested interest in such cases.
CONCLUSIONS


Community-based respondents perceived that DSD conditions were associated with a reduction in utility values (0.70-0.80), on par with moderately severe chronic health conditions. Estimates varied based on respondents' gender, race, religion and prior knowledge of DSD. Gender identity was the most concerning aspect for respondents.",2020,"Most (67.5%) supported early surgical intervention at 6-18 mo; 10.4% thought surgery should occur ≥18 y.
COMMENT


Limitations of this study include that survey participants were aware of the nature of the study, thus some respondents may have participated to skew the results.","[""A cross-sectional survey was posted on Amazon's Mechanical Turk, an online crowdsourcing platform"", 'families with children with DSD', '1,628 respondents']","['DSD conditions: Congenital Adrenal Hyperplasia (CAH), Mixed Gonadal Dysgenesis (MGD), and Partial Androgen Insensitivity Syndrome (PAIS']","['urinary function', 'median overall utility value', 'utility values', 'surgical complications']","[{'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}, {'cui': 'C3494386', 'cui_str': 'Crowd Sourcing'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2930619', 'cui_str': 'Disorder of sexual differentiation'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}]","[{'cui': 'C2930619', 'cui_str': 'Disorder of sexual differentiation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001627', 'cui_str': 'Congenital adrenal hyperplasia'}, {'cui': 'C0018055', 'cui_str': 'Mixed gonadal dysgenesis'}, {'cui': 'C0268301', 'cui_str': 'Reifenstein syndrome'}]","[{'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0455143,"Most (67.5%) supported early surgical intervention at 6-18 mo; 10.4% thought surgery should occur ≥18 y.
COMMENT


Limitations of this study include that survey participants were aware of the nature of the study, thus some respondents may have participated to skew the results.","[{'ForeName': 'M Hassan', 'Initials': 'MH', 'LastName': 'Alkazemi', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Ashley W', 'Initials': 'AW', 'LastName': 'Johnston', 'Affiliation': 'Department of Surgery, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Meglin', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Adkins', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Routh', 'Affiliation': 'Department of Surgery, Duke University School of Medicine, Durham, NC, USA. Electronic address: jonathan.routh@duke.edu.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.03.023']
1394,30470465,Postoperative Recovery After General and Regional Anesthesia in Patients Undergoing Day Surgery: A Mixed Methods Study.,"PURPOSE


To investigate differences and describe experiences of postoperative recovery after day surgery between patients undergoing general anesthesia (GA) versus regional anesthesia (RA).
DESIGN


A mixed methods design.
METHODS


Day surgery patients (N = 401) were included. Postoperative recovery was assessed daily for 14 days using the Swedish Web Version of the Quality of Recovery questionnaire included in a mobile application. In addition, qualitative interviews were completed with 20 day surgery patients. Quantitative and qualitative data were first analyzed separately and then merged.
FINDINGS


There were significant differences in Swedish Web Version of the Quality of Recovery between GA and RA on days 1 to 13 (P < .05). These findings could not be confirmed in the qualitative findings, except for psychological issues as well as tiredness and fatigue. Unexpected issues contributed to a greater extent to the theme not feeling well. Pain in the surgical wound was overall the biggest problem.
CONCLUSIONS


There seems to be a poorer recovery after GA compared with RA. Tiredness or fatigue is present also after minor surgery in RA. Unexpected issues affect recovery negatively, and therefore should be addressed by health care.",2019,"These findings could not be confirmed in the qualitative findings, except for psychological issues as well as tiredness and fatigue.","['Undergoing Day Surgery', 'patients undergoing general anesthesia (GA) versus regional anesthesia (RA', 'Day surgery patients (N\xa0=\xa0401) were included', 'Patients']",[],"['Postoperative Recovery', 'Tiredness or fatigue', 'Swedish Web Version of the Quality of Recovery', 'Pain', 'Postoperative recovery']","[{'cui': 'C0282046', 'cui_str': 'Day Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",401.0,0.245127,"These findings could not be confirmed in the qualitative findings, except for psychological issues as well as tiredness and fatigue.","[{'ForeName': 'Ulrica', 'Initials': 'U', 'LastName': 'Nilsson', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Jaensson', 'Affiliation': ''}, {'ForeName': 'Karuna', 'Initials': 'K', 'LastName': 'Dahlberg', 'Affiliation': ''}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Hugelius', 'Affiliation': ''}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2018.08.003']
1395,31197602,Examining Sleep Quality Following Sleeve Gastrectomy Among Patients with Loss-of-Control Eating.,"BACKGROUND


Sleep is associated with post-bariatric surgical outcomes; however, little is known about sleep in bariatric patients with loss-of-control (LOC) eating, a consistent predictor of poorer weight outcomes. This study examined sleep quality and clinical correlates in sleeve gastrectomy patients with LOC eating.
METHODS


Participants (N = 145) were treatment-seeking post-operative sleeve gastrectomy patients with LOC eating. Eating-disorder features were assessed with the Eating Disorder Examination-Bariatric Surgery Version Interview (EDE-BSV) and participants completed established measures assessing sleep, health-related quality of life, perceived stress, depression, and night eating.
RESULTS


58.6% of participants were characterized with ""poor"" sleep. Poor sleep quality was significantly associated with greater eating-disorder psychopathology, physical and mental functioning, night eating, perceived stress, and less % excess weight loss (EWL); these findings remained significant after controlling for %EWL and race. Regression analyses, adjusting for correlated variables, revealed that sleep quality significantly predicted mental functioning.
CONCLUSIONS


Poor sleep quality was common among post-operative sleeve gastrectomy patients with LOC eating. Sleep quality was significantly associated with eating-disorder psychopathology, less post-operative weight loss, and psychosocial and physical functioning problems. These findings suggest the importance of assessment and treatment of sleep problems following sleeve gastrectomy.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov identifier NCT02259322.",2019,"Poor sleep quality was significantly associated with greater eating-disorder psychopathology, physical and mental functioning, night eating, perceived stress, and less % excess weight loss (EWL); these findings remained significant after controlling for %EWL and race.","['Participants (N\u2009=\u2009145', 'Patients with Loss-of-Control Eating', 'bariatric patients with loss-of-control (LOC) eating', 'post-operative sleeve gastrectomy patients with LOC eating', 'sleeve gastrectomy patients with LOC eating']","['Sleeve Gastrectomy', 'seeking post-operative sleeve gastrectomy patients with LOC eating']","['sleep problems', 'eating-disorder psychopathology, less post-operative weight loss, and psychosocial and physical functioning problems', 'Eating Disorder Examination-Bariatric Surgery Version Interview (EDE-BSV', 'Sleep quality', 'Poor sleep quality', 'eating-disorder psychopathology, physical and mental functioning, night eating, perceived stress, and less % excess weight loss (EWL', 'poor"" sleep', 'sleep, health-related quality of life, perceived stress, depression, and night eating', 'Eating-disorder features']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}]","[{'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}]","[{'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C2732388', 'cui_str': 'Eating disorder examination'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",145.0,0.0297924,"Poor sleep quality was significantly associated with greater eating-disorder psychopathology, physical and mental functioning, night eating, perceived stress, and less % excess weight loss (EWL); these findings remained significant after controlling for %EWL and race.","[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Lawson', 'Affiliation': 'Program for Obesity, Weight, and Eating Research, Psychiatry Department, Yale School of Medicine, 301 Cedar Street, New Haven, CT, 06519, USA. jessica.lawson@yale.edu.'}, {'ForeName': 'Ashley A', 'Initials': 'AA', 'LastName': 'Wiedemann', 'Affiliation': 'Program for Obesity, Weight, and Eating Research, Psychiatry Department, Yale School of Medicine, 301 Cedar Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Meagan M', 'Initials': 'MM', 'LastName': 'Carr', 'Affiliation': 'Program for Obesity, Weight, and Eating Research, Psychiatry Department, Yale School of Medicine, 301 Cedar Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Ivezaj', 'Affiliation': 'Program for Obesity, Weight, and Eating Research, Psychiatry Department, Yale School of Medicine, 301 Cedar Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Duffy', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Grilo', 'Affiliation': 'Program for Obesity, Weight, and Eating Research, Psychiatry Department, Yale School of Medicine, 301 Cedar Street, New Haven, CT, 06519, USA.'}]",Obesity surgery,['10.1007/s11695-019-03981-7']
1396,31149870,Role and plasticity of Th1 and Th17 responses in immunity to  Staphylococcus aureus .,"The human commensal  Staphylococcus aureus  (SA) is a leading cause of skin/soft tissue and surgical-site infections, and bacteremia. Functional antibodies and T-cell-mediated immunity, particularly Th1/Th17 responses, are thought to mediate protection. Vaccine development may be hindered by modulation of vaccine-induced T cells by pathogen-activated immunoregulatory responses, e.g., via IL-10.We screened SA proteins for CD4 +  T-cell-activating and IL-10/IL-17-inducing capacities using healthy donor-derived PBMCs. Responses were characterized (Th1/Th17/Th22/immunosuppressive IL-10-producing cells) using intracellular cytokine staining and flow cytometry. Phenotypic plasticity of Th1/Th17 cells was evaluated under pro- or anti-inflammatory conditions using modulatory cytokines. The impact of vaccination on SA-specific memory responses was assessed using samples from a clinical trial evaluating AS03-adjuvanted and non-adjuvanted multicomponent (CPS5/CPS8/α-toxin/ClfA) vaccines (NCT01160172).The donors exhibited SA-specific memory T-cell responses, indicative of pre-existing immunity to SA. We identified effective activators of Th1 responses (EbhA/IsaA/SdrE/MntC/Aaa/α-toxin), and Th17 and Th1/Th17 responses (EbhA/IsaA/SdrE and, to a lesser extent, α-toxin), but not of Th22 responses or IL-10 production. MRPII, IsdA, and ClfA were inefficient CD4 +  T-cell activators in our assays. IL-10, likely produced by innate immune cells, influenced mainly Th1 cells by suppressing IFN-γ production. The memory CD4 +  T-cells observed after long-term stimulation with α-toxin and ClfA indicated that vaccination with these proteins had induced expansion of pre-existing Th1 but not Th17 responses, without apparent adjuvant effect, confirming the trial data. The Th1/Th17-driving proteins (EbhA/IsaA/SdrE) shared low IL-10-promoting abilities and restricted phenotypic plasticity under pro- and anti-inflammatory conditions.Given the complex immunopathology and multiple virulence factors, identification of Th1/Th17-driving antigens, adjuvants and administration routes, and delineation of the role of memory responses, may advance vaccine development.",2019,Responses were characterized (Th1/Th17/Th22/immunosuppressive IL-10-producing cells) using intracellular cytokine staining and flow cytometry.,[],[],"['memory CD4 +  T-cells', 'SA-specific memory responses', 'MRPII, IsdA, and ClfA']",[],[],"[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",,0.0928145,Responses were characterized (Th1/Th17/Th22/immunosuppressive IL-10-producing cells) using intracellular cytokine staining and flow cytometry.,"[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Ferraro', 'Affiliation': 'GSK Vaccines, GSK, Rixensart, Belgium.'}, {'ForeName': 'Sofia M', 'Initials': 'SM', 'LastName': 'Buonocore', 'Affiliation': 'GSK Vaccines, GSK, Rixensart, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Auquier', 'Affiliation': 'GSK Vaccines, GSK, Rixensart, Belgium.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Nicolas', 'Affiliation': 'GSK Vaccines, GSK, Rixensart, Belgium.'}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Wallemacq', 'Affiliation': 'GSK Vaccines, GSK, Rixensart, Belgium.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Boutriau', 'Affiliation': 'GSK Vaccines, GSK, Rixensart, Belgium.'}, {'ForeName': 'Robbert G', 'Initials': 'RG', 'LastName': 'van der Most', 'Affiliation': 'GSK Vaccines, GSK, Rixensart, Belgium.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1613126']
1397,31148436,"Re-Classifying Hypertension in the Venezuelan EVESCAM Database Using 2017 AHA/ACC Criteria: High Prevalence, Poor Control, and Urgent Call for Action.","BACKGROUND


In 2017 the American Heart Association (AHA)/American College of Cardiology (ACC) changed the criteria to define hypertension (HTN).
OBJECTIVE


To re-analyze Venezuelan data to update HTN prevalence rates and estimate the number of adults with uncontrolled blood pressure (BP) using AHA/ACC criteria.
METHODS


The EVESCAM was a national population-based, cross-sectional, randomized cluster sampling study, which assessed 3,420 adults from July 2014 to January 2017, with a response rate of 77.3%. The mean of two BP measurements was obtained using a standard oscillometric device protocol. HTN was defined using both 2017 AHA/ACC guideline (BP ≥ 130/80 mmHg) and JNC7 (BP ≥ 140/90 mmHg) criteria.
FINDINGS


The crude prevalence of HTN using 2017 AHA/ACC guideline criteria was 60.4%, 13% higher than with the JNC7 criteria. The age-standardized prevalence was 55.4% in men and 49.0% in women (p < 0.001), 17.5% and 12.7% higher, respectively, compared with the JNC7 criteria. In subjects without self-reported HTN, the age-standardized prevalence of HTN was 43.4% in men and 32.3% in women, of whom, 22.9% and 19.2% were between 130-139/80-89 mmHg, respectively. In those with self-reported HTN, the prevalence of uncontrolled BP (≥130/80 mmHg) on antihypertensive medication was 66.8% in men and 65.8% in women. The total estimated number of subjects with HTN in Venezuela increased to 11 million, and only about 1.8 million are controlled.
CONCLUSION


Using the new 2017 AHA/ACC guideline, the prevalence of HTN in Venezuela is approximately half of the adult population and associated with relatively poor BP control.",2019,"The age-standardized prevalence was 55.4% in men and 49.0% in women (p < 0.001), 17.5% and 12.7% higher, respectively, compared with the JNC7 criteria.","['adults with uncontrolled blood pressure (BP) using AHA/ACC criteria', '3,420 adults from July 2014 to January 2017, with a response rate of 77.3']",['EVESCAM'],"['age-standardized prevalence', 'mean of two BP measurements', 'uncontrolled BP', 'antihypertensive medication']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",[],"[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",3420.0,0.0425789,"The age-standardized prevalence was 55.4% in men and 49.0% in women (p < 0.001), 17.5% and 12.7% higher, respectively, compared with the JNC7 criteria.","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'González-Rivas', 'Affiliation': 'The Andes Clinic of Cardio-Metabolic Studies, Mérida, VE.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Mechanick', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, US.'}, {'ForeName': 'Maritza', 'Initials': 'M', 'LastName': 'Duran', 'Affiliation': 'Avila Clinic, VE.'}, {'ForeName': 'Eunice', 'Initials': 'E', 'LastName': 'Ugel', 'Affiliation': 'School of Medicine, University Centro-Occidental ""Lisandro Alvarado"", Barquisimeto, VE.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Marulanda', 'Affiliation': 'Endocrine Associates of Florida, Orlando, Florida, US.'}, {'ForeName': 'Ramfis', 'Initials': 'R', 'LastName': 'Nieto-Martínez', 'Affiliation': 'South Florida Veterans Affairs Foundation for Research & Education and Geriatric Research, Education, and Clinical Center (GRECC), Miami VA Healthcare System, Miami, Florida, US.'}]",Annals of global health,['10.5334/aogh.2346']
1398,31218759,The assessment of cognitive-behavioral therapy skills in patients diagnosed with health anxiety: Development and pilot study on an observer-based rating scale.,"Cognitive-behavioral therapy is a highly effective treatment of health anxiety, but it remains unclear through which mechanisms treatment effects prevail. Some evidence suggests that patients acquire skills-understood as techniques helping them reach therapy goals-through psychotherapy. In the current study, an observer-based rating scale for the skills assessment of patients with health anxiety (SAPH) was developed and validated in a pilot study. Based on 177 videotapes, four independent raters evaluated the frequency of skills acquired during cognitive and exposure therapy among 66 patients diagnosed with health anxiety with the SAPH. Predictive validity was evaluated by the Yale-Brown Obsessive-Compulsive Scale for Hypochondriasis. The SAPH demonstrated good interrater reliability (ICC (1,2)   = .88, p < .001, 95% CI [.81, .92]) and internal consistency (α = .94). Although patient skills did not significantly increase during three sessions, they significantly predicted a reduction in health anxiety symptoms at the end of treatment (R 2   = .35). Patients' skills are highly important within the treatment of health anxiety. By providing external ratings of patients' skills with good psychometric properties, our pilot data suggest that the SAPH may complement current tools for the assessment of skills, specifically in targeting health anxiety.",2019,"The SAPH demonstrated good interrater reliability (ICC (1,2)   = .88, p < .001, 95% CI [.81, .92]) and internal consistency (α = .94).","['patients with health anxiety (SAPH', 'patients diagnosed with health anxiety', '66 patients diagnosed with health anxiety with the SAPH']",['Cognitive-behavioral therapy'],"['Predictive validity', 'health anxiety symptoms', 'good interrater reliability', 'cognitive-behavioral therapy skills', 'Yale-Brown Obsessive-Compulsive Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0223358,"The SAPH demonstrated good interrater reliability (ICC (1,2)   = .88, p < .001, 95% CI [.81, .92]) and internal consistency (α = .94).","[{'ForeName': 'Destina Sevde', 'Initials': 'DS', 'LastName': 'Ay', 'Affiliation': 'Department of Psychology, Clinical Psychology and Psychotherapy, University of Potsdam, Potsdam, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Kühne', 'Affiliation': 'Department of Psychology, Clinical Psychology and Psychotherapy, University of Potsdam, Potsdam, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Weck', 'Affiliation': 'Department of Psychology, Clinical Psychology and Psychotherapy, University of Potsdam, Potsdam, Germany.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2387']
1399,30370532,Prolonged exercise training improves the acute type II muscle fibre satellite cell response in healthy older men.,"KEY POINTS


Skeletal muscle stem cells, termed satellite cells, play a crucial role in repair and remodelling of muscle in response to exercise An age-related decline in satellite cell number and/or function has been hypothesized to be a key factor in the development of sarcopenia and/or the blunted muscle fibre adaptive response to prolonged exercise training in older persons We report that performing prolonged exercise training improves the acute type II muscle fibre satellite cell response following a single bout of resistance exercise in older men. The observed improvement in muscle satellite function is associated with an increase in muscle fibre capillarization following exercise training suggesting a possible functional link between capillarization and satellite cell function.
ABSTRACT


Age-related type II muscle fibre atrophy is accompanied by a fibre type-specific decline in satellite cell number and function. Exercise training restores satellite cell quantity in older adults; however, whether it can restore the impaired satellite cell response to exercise in older adults remains unknown. Therefore we assessed the acute satellite cell response to a single exercise session before and after prolonged exercise training in older men. Fourteen older men (74 ± 8 years) participated in a 12-week exercise training programme (resistance exercise performed twice per week, high intensity interval training once per week). Before and after training, percutaneous biopsies from the vastus lateralis muscle were taken prior to and following 24 and 48 h of post-exercise recovery. Muscle fibre characteristics were evaluated by immunohistochemistry and mRNA expression by RT-PCR. Whereas no changes were observed in type II muscle fibres, type I muscle fibre satellite cell content increased significantly at 24 and 48 h after a single bout of resistance exercise before the exercise training programme (P < 0.01). Following the exercise training programme, both type I and type II muscle fibre satellite cell content increased significantly at 24 and 48 h after a single bout of resistance exercise (P < 0.05). The greater acute increase in type II muscle fibre satellite cell content at 24 h post-exercise recovery after training was correlated with an increase in type II muscle fibre capillarization (r = 0.671, P = 0.012). We show that the acute muscle satellite cell response following exercise can be improved by prolonged exercise training in older men.",2019,"Following the exercise training programme, both type I and type II muscle fibre satellite cell content increased significantly at 24 and 48 h after a single bout of resistance exercise (P < 0.05).","['older adults', 'older men', 'healthy older men', 'older persons', 'Fourteen older men (74\xa0±\xa08\xa0years']","['Prolonged exercise training', 'Exercise training', 'prolonged exercise training', 'resistance exercise', 'exercise training programme (resistance exercise performed twice per week, high intensity interval training']","['acute type II muscle fibre satellite cell response', 'acute satellite cell response', 'muscle satellite function', 'type II muscle fibre capillarization', 'type II muscle fibres, type I muscle fibre satellite cell content']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0205868', 'cui_str': 'Perineuronal satellite cell'}, {'cui': 'C0036238', 'cui_str': 'Associated Viruses'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",,0.0292499,"Following the exercise training programme, both type I and type II muscle fibre satellite cell content increased significantly at 24 and 48 h after a single bout of resistance exercise (P < 0.05).","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Snijders', 'Affiliation': 'Department of Kinesiology and Medical Physics & Applied Radiation Sciences, McMaster University, Hamilton, Ontario, Canada, L8S 4K1.'}, {'ForeName': 'Joshua P', 'Initials': 'JP', 'LastName': 'Nederveen', 'Affiliation': 'Department of Kinesiology and Medical Physics & Applied Radiation Sciences, McMaster University, Hamilton, Ontario, Canada, L8S 4K1.'}, {'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Bell', 'Affiliation': 'Department of Kinesiology and Medical Physics & Applied Radiation Sciences, McMaster University, Hamilton, Ontario, Canada, L8S 4K1.'}, {'ForeName': 'Sean W', 'Initials': 'SW', 'LastName': 'Lau', 'Affiliation': 'Department of Kinesiology and Medical Physics & Applied Radiation Sciences, McMaster University, Hamilton, Ontario, Canada, L8S 4K1.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mazara', 'Affiliation': 'Department of Kinesiology and Medical Physics & Applied Radiation Sciences, McMaster University, Hamilton, Ontario, Canada, L8S 4K1.'}, {'ForeName': 'Dinesh A', 'Initials': 'DA', 'LastName': 'Kumbhare', 'Affiliation': 'Toronto Rehabilitation Institute, University of Toronto, Toronto, Ontario, Canada, M5G 2A2.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Phillips', 'Affiliation': 'Department of Kinesiology and Medical Physics & Applied Radiation Sciences, McMaster University, Hamilton, Ontario, Canada, L8S 4K1.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Parise', 'Affiliation': 'Department of Kinesiology and Medical Physics & Applied Radiation Sciences, McMaster University, Hamilton, Ontario, Canada, L8S 4K1.'}]",The Journal of physiology,['10.1113/JP276260']
1400,31641729,Red Blood Cell Omega-3 Fatty Acid Composition and Psychotropic Drug Use in Older Adults: Results from the MAPT Study.,"Low docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) concentration has been associated with the development of some psychiatric disorders.
OBJECTIVES


to assess the association between red blood cell (RBC) DHA-EPA concentration and psychotropic drug use in older adults and between the 1-year change in RBC DHA-EPA and psychotropic drug use at 12 months.
DESIGN


secondary analysis of multicenter, randomized controlled trial testing multidomain intervention and/or n-3 PUFA supplement on cognitive function (MAPT study).
SETTING


France, 2008-2014.
PARTICIPANTS


1680 participants ≥70 years, community-dwelling were included.
MEASUREMENTS


Psychotropic drug use was self-reported during medical interviews and assessments. RBC n-3 PUFA concentration was defined by % of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) among total fatty acids. Logistic regressions models controlling for age, sex, education, depression risk and intervention group were used.
RESULTS


1594 participants had baseline DHA-EPA concentration available (mean age=75.5±4.5 years, 65% females). At baseline, participants with DHA-EPA ≤4.82% (lowest quartile) reported higher prevalence of use of overall psychotropic drugs (34.0% vs 24.4%; aOR=1.33, 95%CI=[1.03-1.72]), anxiolytic/hypnotic drugs (25.0% vs 18.2%; aOR=1.42, 95%CI=[1.07-1.89]), and antidepressants (18.3% vs 13.5%; aOR=1.25, 95%CI=[0.93-1.72]) than participants with higher DHA-EPA. Participants who experienced an increase in DHA-EPA from baseline were less likely to use a psychotropic drug at 12 months than participants with no change or a decrease (aOR=0.72, 95%CI=[0.55-0.96]).
CONCLUSION


Low RBC DHA-EPA concentration was independently associated with psychotropic drug use. Future studies are needed to assess whether low RBC DHA-EPA is a risk marker for psychotropic drug use in older adults and to better understand underlying pathophysiological mechanisms. Registration number: ClinicalTrials.gov database (NCT00672685).",2019,"At baseline, participants with DHA-EPA ≤4.82% (lowest quartile) reported higher prevalence of use of overall psychotropic drugs (34.0% vs 24.4%; aOR=1.33, 95%CI=[1.03-1.72]), anxiolytic/hypnotic drugs (25.0% vs 18.2%; aOR=1.42, 95%CI=[1.07-1.89]), and antidepressants (18.3% vs 13.5%; aOR=1.25, 95%CI=[0.93-1.72]) than participants with higher DHA-EPA.","['1594 participants had baseline DHA-EPA concentration available (mean age=75.5±4.5 years, 65% females', '1680 participants ≥70 years, community-dwelling were included', 'older adults', 'Older Adults', 'France, 2008-2014']","['multidomain intervention and/or n-3 PUFA supplement', 'Low docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA', 'docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA']","['Low RBC DHA-EPA concentration', 'DHA-EPA', 'prevalence of use of overall psychotropic drugs', 'RBC n-3 PUFA concentration', 'anxiolytic/hypnotic drugs', 'red blood cell (RBC) DHA-EPA concentration']","[{'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517596', 'cui_str': '1680'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033978', 'cui_str': 'Psychoactive Drugs'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0040616', 'cui_str': 'Anti-Anxiety Drugs'}, {'cui': 'C0020591', 'cui_str': 'Hypnotics'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}]",1594.0,0.31734,"At baseline, participants with DHA-EPA ≤4.82% (lowest quartile) reported higher prevalence of use of overall psychotropic drugs (34.0% vs 24.4%; aOR=1.33, 95%CI=[1.03-1.72]), anxiolytic/hypnotic drugs (25.0% vs 18.2%; aOR=1.42, 95%CI=[1.07-1.89]), and antidepressants (18.3% vs 13.5%; aOR=1.25, 95%CI=[0.93-1.72]) than participants with higher DHA-EPA.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gallini', 'Affiliation': 'Adeline Gallini, PharmD, PhD, Epidemiology Department 37 allées Jules Guesde, 31062 Toulouse Cedex, Tel : +33 5 61 14 56 81, Fax : + 33 5 62 26 42 40, Email : adeline.gallini@univ-tlse3.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Yrondi', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cantet', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Poncet', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Schmitt', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Andrieu', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-019-1252-4']
1401,31641732,Effect of a Resistance Training Program on Sarcopenia and Functionality of the Older Adults Living in a Nursing Home.,"IMPORTANCE


There are currently few evidence about resistance training as a treatment for sarcopenia in the nursing home setting.
OBJECTIVE


To evaluate the effect of a resistance training program on the sarcopenia and functionality of the elderly living in a nursing home.
DESIGN, SETTING, AND PARTICIPANTS


A blinded longitudinal intervention study conducted in elderly people living in a nursing home from August to November 2016. Participants included a convenience sample of 19 older adults.
INTERVENTION


We prescribed a resistance exercise program three times a week for 12 weeks. The scheme was two to three sets with eight to 15 repetitions per exercise.
MAIN OUTCOME AND MEASURES


The primary outcome was an increase in muscle strength and an improvement in physical performance of the elderly people living in nursing homes.
RESULTS


19 older adults between 77.7 ± 8.9 years old, completed the 12 week resistance exercise program achieving a significant increase in muscle strength to 5.7 Kg (p = 0.0001) as well as nutritional intake for the first four weeks (p = 0.001); we found an improvement in physical performance (p = 0.0001) in balance (p = 0.0001), chair stand (p = 0.036) and gait speed (p = 0.0001). Of the 47.4% that reached sarcopenia degree, in the end it was 33.3%. A relationship with nutritional status (p = 0.004) and age (p = 0.019) was found with the initial and final handgrip strength (p = 0.041).
CONCLUSIONS AND RELEVANCE


The resistance training program improves the functionality (muscle strength and physical performance), with the benefit of the decrease in severe sarcopenia.",2019,"The primary outcome was an increase in muscle strength and an improvement in physical performance of the elderly people living in nursing homes.
","['19 older adults between 77.7 ± 8.9 years old', 'elderly living in a nursing home', 'Older Adults Living in a Nursing Home', 'elderly people living in a nursing home from August to November 2016', 'Participants included a convenience sample of 19 older adults']","['Resistance Training Program', 'resistance training program']","['physical performance of the elderly people living in nursing homes', 'gait speed', 'chair stand', 'nutritional intake', 'initial and final handgrip strength', 'physical performance', 'muscle strength', 'severe sarcopenia', 'functionality (muscle strength and physical performance']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C2607857'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home (finding)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenias'}]",19.0,0.0231637,"The primary outcome was an increase in muscle strength and an improvement in physical performance of the elderly people living in nursing homes.
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Martín Del Campo Cervantes', 'Affiliation': 'Rebeca Monroy Torres, Department of Medicine and Nutrition, Universidad de Guanajuato, Campus León, Street Name and Number: Blvd. Puente del Milenio 1001; Fraccionamiento del Predio de San Carlos, City, State, Postal code, Country: León, Guanajuato, postal code 37670, México, Tel: +52 (477) 2674900, ext 3677, E-mail: rmonroy79@gmail.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Habacuc Macías Cervantes', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Monroy Torres', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-019-1261-3']
1402,29985719,Bio-Electro-Magnetic-Energy-Regulation (BEMER) for the treatment of type I complex regional pain syndrome: A pilot study.,"Objective:  The study aimed to evaluate the efficacy of Bio-Electro-Magnetic-Energy-Regulation (BEMER) magneto-therapy on pain and functional outcome in complex regional pain syndrome type I (CRPS-I). We hypothesized that BEMER therapy, based on its declared effects on microcirculation, could be beneficial in the treatment of this condition.  Methods:  This was a randomized controlled double-blind pilot study that included 30 patients with CRPS-I. Patients were divided into two groups: a study group, in which the rehabilitation program was combined with BEMER therapy for 10 consecutive days, and a control group, in which the rehabilitation program was combined with a sham BEMER treatment. Outcome measures (Visual Analogic Scale pain; Hand Grip Strength; Disabilities of the Arm, Shoulder, and Hand ; Maryland Foot Score) were taken at the beginning and end of treatment, and at 1 month follow-up.  Results:  The study demonstrated that the group treated with BEMER combined with rehabilitation yielded better results in the short term, in terms of pain reduction and functional improvement both at the upper and lower limbs.  Conclusions:  Data from the present pilot study suggest that BEMER therapy can be indicated, in combination with traditional rehabilitation programs, for the treatment of CRPS-I.",2020,"The study demonstrated that the group treated with BEMER combined with rehabilitation yielded better results in the short term, in terms of pain reduction and functional improvement both at the upper and lower limbs.
","['30 patients with CRPS-I. Patients', 'type I complex regional pain syndrome', 'complex regional pain syndrome type']","['BEMER', 'Bio-Electro-Magnetic-Energy-Regulation (BEMER', 'rehabilitation program was combined with BEMER therapy', 'Bio-Electro-Magnetic-Energy-Regulation (BEMER) magneto-therapy']","['pain and functional outcome', 'Outcome measures (Visual Analogic Scale pain; Hand Grip Strength; Disabilities of the Arm, Shoulder, and Hand ; Maryland Foot Score', 'pain reduction and functional improvement both at the upper and lower limbs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034931', 'cui_str': 'CRPS Type I'}, {'cui': 'C0458219', 'cui_str': 'CRPS (Complex Regional Pain Syndromes)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]",30.0,0.0445093,"The study demonstrated that the group treated with BEMER combined with rehabilitation yielded better results in the short term, in terms of pain reduction and functional improvement both at the upper and lower limbs.
","[{'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Benedetti', 'Affiliation': 'Physical Medicine and Rehabilitation Unit, Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Cavazzuti', 'Affiliation': 'Physical Medicine and Rehabilitation Unit, Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Mosca', 'Affiliation': 'Orthopaedic and Traumatologic Clinic, Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Fusaro', 'Affiliation': 'Physical Medicine and Rehabilitation Unit, Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Zati', 'Affiliation': 'Physical Medicine and Rehabilitation Unit, Istituto Ortopedico Rizzoli, Bologna, Italy.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1491661']
1403,32411031,Effect of Electroacupuncture and Counseling on Sub-Threshold Depression: A Study Protocol for a Multicenter Randomized Controlled Trial.,"Background


Sub-threshold depression is common and could impair function, as well as increase the risk of developing major depression. Despite evidence of efficacy for electroacupuncture (EA) and counseling in the treatment of sub-threshold depression, the sample size is insufficient and the level of evidence remains low. This study aims to evaluate the effectiveness of sub-threshold depression treatments by comparing the treatment effects among EA, counseling, and combination therapy, as well as to further study their mechanism.
Methods


This study is a multicenter, randomized, single blind clinical trial that will be conducted in settings at four clinical centers in China. The randomized controlled trial (RCT) will examine the effectiveness of EA intervention, compared with counseling and combination therapy. A total of 138 sub-threshold depression patients (18 to 55 years of age with Beck Depression Inventory (BDI-II) score ≥ 14 points and Hamilton Depression Scale (HAMD-17) score: 7 points ≤ HAMD total score <17 points) will be recruited. The participants will be randomly assigned to receive the above treatments. The interventions will be delivered over a 6-week period (EA: 3 times a week for 6 weeks; 30 min a session. Counseling: once a week for 6 weeks; 50-60 min a session). The primary outcome measure will be the HAMD-17; BDI-II. The secondary outcome measures will be: Self-rating Depression Scale (SDS), Self-rating Anxiety Scale (SAS), and Pittsburgh Sleep Quality Index (PSQI). The assessments will occur at baseline, 2, 4, and 6 weeks and a follow-up period. Recruitment will commence in March 2020 and is anticipated to occur over a 2-year period.
Discussion


This study intends to conduct a multicenter randomized controlled trial to compare the effectiveness among EA, counseling and the combined therapy in the treatment of patients with sub-threshold depression, and to further study the mechanisms of effect.
Chinese Clinical Trial Registry registration


www.chictr.org.cn/, identifier ChiCTR1900028530.",2020,"The secondary outcome measures will be: Self-rating Depression Scale (SDS), Self-rating Anxiety Scale (SAS), and Pittsburgh Sleep Quality Index (PSQI).","['settings at four clinical centers in China', 'patients with sub-threshold depression', 'A total of 138 sub-threshold depression patients (18 to 55 years of age with Beck Depression Inventory (BDI-II) score ≥ 14 points and Hamilton Depression Scale (HAMD-17) score: 7 points ≤ HAMD total score <17 points) will be recruited']","['electroacupuncture (EA', 'Electroacupuncture and Counseling', 'EA intervention']","['HAMD-17; BDI-II', 'Self-rating Depression Scale (SDS), Self-rating Anxiety Scale (SAS), and Pittsburgh Sleep Quality Index (PSQI', 'Sub-Threshold Depression']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",,0.214497,"The secondary outcome measures will be: Self-rating Depression Scale (SDS), Self-rating Anxiety Scale (SAS), and Pittsburgh Sleep Quality Index (PSQI).","[{'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'South China Research Center for Acupuncture and Moxibustion, Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Haixiong', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'The First School of Clinical Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Xiumin', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'South China Research Center for Acupuncture and Moxibustion, Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Ma', 'Affiliation': 'Student Mental Health Counseling Center, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Shi', 'Affiliation': 'Student Mental Health Counseling Center, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Fan', 'Affiliation': 'South China Research Center for Acupuncture and Moxibustion, Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Shao', 'Affiliation': 'South China Research Center for Acupuncture and Moxibustion, Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Shengwei', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Traditional Chinese Medicine, Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Department of Traditional Chinese Medicine, Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Danian', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Rehabilitation Center, Counseling Department, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'South China Research Center for Acupuncture and Moxibustion, Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'South China Research Center for Acupuncture and Moxibustion, Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00346']
1404,32411007,"Effect of Resistance Training Under Normobaric Hypoxia on Physical Performance, Hematological Parameters, and Body Composition in Young and Older People.","Background


Resistance training (RT) under hypoxic conditions has been used to increase muscular performance under normoxic conditions in young people. However, the effects of RT and thus of RT under hypoxia (RTH) could also be valuable for parameters of physical capacity and body composition across the lifespan. Therefore, we compared the effects of low- to moderate-load RTH with matched designed RT on muscular strength capacity, cardiopulmonary capacity, hematological adaptation, and body composition in young and older people.
Methods


In a pre-post randomized, blinded, and controlled experiment, 42 young (18 to 30 year) and 42 older (60 to 75 year) participants were randomly assigned to RTH or RT (RTH young, RT young, RTH old, RT old). Both groups performed eight resistance exercises (25-40% of 1RM, 3 × 15 repetitions) four times a week over 5 weeks. The intensity of hypoxic air for the RTH was administered individually in regards to the oxygen saturation of the blood (SpO 2 ): ∼80-85%. Changes and differences in maximal isokinetic strength, cardiopulmonary capacity, total hemoglobin mass (tHb), blood volume (BV), fat free mass (FFM), and fat mass (FM) were determined pre-post, and the acute reaction of erythropoietin (EPO) was tested during the intervention.
Results


In all parameters, no significant pre-post differences in mean changes (time × group effects  p  = 0.120 to 1.000) were found between RTH and RT within the age groups. However, within the four groups, isolated significant improvements ( p  < 0.050) of the single groups were observed regarding the muscular strength of the legs and the cardiopulmonary capacity.
Discussion


Although the hypoxic dose and the exercise variables of the resistance training in this study were based on the current recommendations of RTH, the RTH design used had no superior effect on the tested parameters in young and older people in comparison to the matched designed RT under normoxia after a 5-week intervention period. Based on previous RTH-studies as well as the knowledge about RT in general, it can be assumed that the expected higher effects of RTH can may be achieved by changing exercise variables (e.g., longer intervention period, higher loads).",2020,"In all parameters, no significant pre-post differences in mean changes (time × group effects  p  = 0.120 to 1.000) were found between RTH and RT within the age groups.","['young people', 'young and older people', 'Young and Older People', '42 young (18 to 30 year) and 42 older (60 to 75 year) participants']","['Resistance Training Under Normobaric Hypoxia', '\n\n\nResistance training (RT', 'RTH or RT']","['muscular strength of the legs and the cardiopulmonary capacity', 'acute reaction of erythropoietin (EPO', 'Physical Performance, Hematological Parameters, and Body Composition', 'maximal isokinetic strength, cardiopulmonary capacity, total hemoglobin mass (tHb), blood volume (BV), fat free mass (FFM), and fat mass (FM', 'muscular strength capacity, cardiopulmonary capacity, hematological adaptation, and body composition']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0475206', 'cui_str': '% total hemoglobin'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]",,0.012693,"In all parameters, no significant pre-post differences in mean changes (time × group effects  p  = 0.120 to 1.000) were found between RTH and RT within the age groups.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Törpel', 'Affiliation': 'Department Health and Physical Activity, Institute III Sport Science, Otto von Guericke University Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Peter', 'Affiliation': 'Department Health and Physical Activity, Institute III Sport Science, Otto von Guericke University Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Schega', 'Affiliation': 'Department Health and Physical Activity, Institute III Sport Science, Otto von Guericke University Magdeburg, Magdeburg, Germany.'}]",Frontiers in physiology,['10.3389/fphys.2020.00335']
1405,32411014,Ischemic Preconditioning Did Not Affect Central and Peripheral Factors of Performance Fatigability After Submaximal Isometric Exercise.,"The present study was designed to provide further insight into the mechanistic basis for the improved exercise tolerance following ischemic preconditioning (IPC) by investigating key-determinants of performance and perceived fatigability. Using a randomized, counterbalanced, single-blind, sham-controlled, crossover design, 16 males performed an isometric time-to-exhaustion test with the knee extensors at 20% maximal voluntary torque (MVT) after an IPC and a sham treatment (SHAM). Those who improved their time-to-exhaustion following IPC performed a time-matched IPC trial corresponding to the exercise duration of SHAM (IPC tm ). Neuromuscular function was assessed before and after exercise termination during each condition (IPC, IPC tm , and SHAM) to analyze the impact of IPC on performance fatigability and its central and peripheral determinants. Muscle oxygenation (SmO 2 ), muscle activity, and perceptual responses (effort and muscle pain) were recorded during exercise. Performance fatigability as well as its central and peripheral determinants were quantified as percentage pre-post changes in MVT (ΔMVT) as well as voluntary activation (ΔVA) and quadriceps twitch torque evoked by paired electrical stimuli at 100 and 10 Hz (ΔPS100 and ΔPS10⋅PS100 -1  ratio), respectively. Time-to-exhaustion, performance fatigability, its determinants, muscle activity, SmO 2 , and perceptual responses during exercise were not different between IPC and SHAM. However, six participants improved their performance by >10% following IPC (299 ± 71 s) compared to SHAM (253 ± 66 s,  d  = 3.23). The time-matched comparisons (IPC tm  vs. SHAM) indicated that performance fatigability, its determinants, and SmO 2  were not affected, while effort perception seemed to be lower (η p   2  = 0.495) in those who improved their time-to-exhaustion. The longer time-to-exhaustion following IPC seemed to be associated with a lower effort perception (η p   2  = 0.380) and larger impairments in neuromuscular function, i.e., larger ΔMVT, ΔVA, and ΔPS10⋅PS100 -1  ratio ( d  = 0.71, 1.0, 0.92, respectively). IPC did neither affect exercise tolerance, performance fatigability, as well as its central and peripheral determinants, nor muscle activity, SmO 2 , and perceptual responses during submaximal isometric exercise. However, IPC seemed to have an ergogenic effect in a few subjects, which might have resulted from a lower effort perception during exercise. These findings support the assumption that there are 'responders' and 'non-responders' to IPC.",2020,"IPC did neither affect exercise tolerance, performance fatigability, as well as its central and peripheral determinants, nor muscle activity, SmO 2 , and perceptual responses during submaximal isometric exercise.",['16 males performed an'],"['Submaximal Isometric Exercise', 'isometric time-to-exhaustion test with the knee extensors at 20% maximal voluntary torque (MVT) after an IPC and a sham treatment (SHAM', 'IPC', 'Ischemic Preconditioning']","['Fatigability', 'Muscle oxygenation (SmO 2 ), muscle activity, and perceptual responses (effort and muscle pain', 'larger ΔMVT, ΔVA, and ΔPS10⋅PS100 -1  ratio', 'longer time-to-exhaustion', 'voluntary activation (ΔVA) and quadriceps twitch torque evoked by paired electrical stimuli', 'Central and Peripheral Factors of Performance', 'Neuromuscular function', 'exercise tolerance, performance fatigability, as well as its central and peripheral determinants, nor muscle activity, SmO 2 , and perceptual responses', 'Time-to-exhaustion, performance fatigability, its determinants, muscle activity, SmO 2 , and perceptual responses during exercise']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231230', 'cui_str': 'Fatigability'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0574401', 'cui_str': 'Samoan language'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}]",16.0,0.157523,"IPC did neither affect exercise tolerance, performance fatigability, as well as its central and peripheral determinants, nor muscle activity, SmO 2 , and perceptual responses during submaximal isometric exercise.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Behrens', 'Affiliation': 'Institute of Sport Science, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Zschorlich', 'Affiliation': 'Institute of Sport Science, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mittlmeier', 'Affiliation': 'Department of Traumatology, Hand and Reconstructive Surgery, University Medicine Rostock, Rostock, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Bruhn', 'Affiliation': 'Institute of Sport Science, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Husmann', 'Affiliation': 'Institute of Sport Science, University of Rostock, Rostock, Germany.'}]",Frontiers in physiology,['10.3389/fphys.2020.00371']
1406,31646707,Is plasma renin activity associated with worse outcomes in acute heart failure? A secondary analysis from the BLAST-AHF trial.,"AIMS


Neurohormonal activation characterizes chronic heart failure (HF) and is a well-established therapeutic target. Neurohormonal activation may also play a key role in acute HF (AHF). We aim to describe the association between plasma renin activity (PRA) and three AHF outcomes: (i) worsening HF or death through day 5 of hospitalization; (ii) HF rehospitalization or death through day 30; and (iii) all-cause death through day 30.
METHODS AND RESULTS


A secondary analysis of the BLAST-AHF trial was performed. Eligible patients had a history of HF, elevated natriuretic peptides, signs and symptoms of HF, systolic blood pressure >120 mmHg, and an estimated glomerular filtration rate between 20-75 mL/min/1.73 m 2  . The primary trial was neutral, with no differential effect of study drug by PRA levels. Baseline PRA levels were grouped into tertiles. Adjusted Cox proportional hazard model determined the association of PRA levels with outcomes (α set at P < 0.05). Of 618 randomized patients, 578 (93.5%) had a baseline PRA. PRA was modestly, but significantly, associated with each outcome without adjustment [worsening HF or death through day 5: hazard ratio (HR) 1.11, 95% confidence interval (CI) 1.01-1.23, P = 0.04; HF rehospitalization or death through day 30: HR 1.13, 95% CI 1.02-1.26, P = 0.02; all-cause death through day 30: HR 1.18, 95% CI 1.02-1.37, P = 0.03]. After multivariable adjustment, PRA was only significantly associated with HF rehospitalization or death through day 30 (HR 1.15, 95% CI 1.01-1.32, P = 0.04).
CONCLUSION


Baseline PRA levels are associated with increased risk for the composite of 30-day HF rehospitalization or death in patients with AHF.",2019,Baseline PRA levels are associated with increased risk for the composite of 30-day HF rehospitalization or death in patients with AHF.,"['Eligible patients had a history of HF, elevated natriuretic peptides, signs and symptoms of HF, systolic blood pressure >120\u2009mmHg, and an estimated glomerular filtration rate between 20-75\u2009mL/min/1.73\u2009m 2  ', 'patients with AHF', '618 randomized patients, 578 (93.5%) had a baseline PRA']",[],"['PRA levels', 'HF rehospitalization or death', 'plasma renin activity (PRA) and three AHF outcomes: (i) worsening HF or death through day 5 of hospitalization; (ii) HF rehospitalization or death through day 30; and (iii) all-cause death', 'Baseline PRA levels', 'PRA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C3811844'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}]",[],"[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]",618.0,0.221702,Baseline PRA levels are associated with increased risk for the composite of 30-day HF rehospitalization or death in patients with AHF.,"[{'ForeName': 'Rayan Jo', 'Initials': 'RJ', 'LastName': 'Rachwan', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'SUNY Stonybrook School of Medicine, New York, NY, USA.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Collins', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Gad', 'Initials': 'G', 'LastName': 'Cotter', 'Affiliation': 'Momentum Research Inc., Durham, NC, USA.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Davison', 'Affiliation': 'Momentum Research Inc., Durham, NC, USA.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Senger', 'Affiliation': 'Momentum Research Inc., Durham, NC, USA.'}, {'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Ezekowitz', 'Affiliation': 'University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'National and Kapodistrian University of Athens, School of Medicine, Heart Failure Unit, Department of Cardiology, Attikon University Hospital, Athens, Greece.'}, {'ForeName': 'Phillip D', 'Initials': 'PD', 'LastName': 'Levy', 'Affiliation': 'Wayne State University School of Medicine and Cardiovascular Research Institute, Detroit, MI, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Cardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Clinical Military Hospital, Medical University, Wroclaw, Poland.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Rudolf A', 'Initials': 'RA', 'LastName': 'de Boer', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Soergel', 'Affiliation': 'Cardiovascular and Metabolic Diseases, Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Duke University School of Medicine and the Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Pang', 'Affiliation': 'Department of Emergency Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.'}]",European journal of heart failure,['10.1002/ejhf.1607']
1407,31932571,The Effect of a Social Skills Program on Violent Behaviors in Children Aged 60~72 Months.,"PURPOSE


To determine the effects of a child and parent program on developing social skills for preventing violent behaviors in children aged 60~72 months through a specially developed pre and posttest, control group, quasi-experimental study.
METHODS


A social skills development program based on Gardner's Multiple Intelligence Theory was used. The data were collected using the Social Skills Assessment Scale (SSAS), a Chart to Monitor Verbal and Behavioral Violence in Children, the Parental Attitude Scale and the Parent Interview Form. This quasi-experimental study that included a pretest, posttest, and control group had a sample comprising 67 children and parents, with 36 in the experimental group, and 31 in the control group.
RESULTS


Over a six-month period, while the social skill scores of the children in the experimental and control groups increased, their violent behaviors decreased ( p <.050). Increase in social skill scores and decrease in violent behaviors were higher in the experimental than in the control group children ( p <.050). The parents in the experimental group stated that they had started to empathize with their children, using ""I"" language, and applied rules more consistently after the program.
CONCLUSION


This program was successful in preventing violent behaviors in children through the development of social skills. Hence, it can be effectively implemented through a teacher/nurse collaboration.",2019,Increase in social skill scores and decrease in violent behaviors were higher in the experimental than in the control group children ( p <.050).,"['67 children and parents, with 36 in the experimental group, and 31 in the control group', 'children aged 60~72 months through a specially developed pre and posttest, control group, quasi-experimental study', 'Children Aged 60~72 Months']","['child and parent program', 'Social Skills Program']","['social skill scores', 'Social Skills Assessment Scale (SSAS), a Chart to Monitor Verbal and Behavioral Violence in Children, the Parental Attitude Scale and the Parent Interview Form', 'Violent Behaviors', 'violent behaviors']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C2985410', 'cui_str': 'Clinical Trials, Nonrandomized'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0222045'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0424323', 'cui_str': 'Physical aggression (finding)'}]",67.0,0.0153299,Increase in social skill scores and decrease in violent behaviors were higher in the experimental than in the control group children ( p <.050).,"[{'ForeName': 'Tülay', 'Initials': 'T', 'LastName': 'Kuzlu Ayyildiz', 'Affiliation': 'Department of Pediatric Nursing, Faculty of Health Sciences, Zonguldak Bülent Ecevit University, Zonguldak, Turkey. tkayyildiz@beun.edu.tr.'}, {'ForeName': 'Güler', 'Initials': 'G', 'LastName': 'Cimete', 'Affiliation': 'Department of Midwery, Faculty of Health Sciences, Üsküdar University, Istanbul, Turkey.'}]",Journal of Korean Academy of Nursing,['10.4040/jkan.2019.49.6.771']
1408,29799307,"Comparison of breathing patterns, pressure, volume, and flow characteristics of three breathing techniques to encourage lung inflation in healthy older people.","Background : It is important to encourage lung inflation to prevent postsurgical pulmonary complications and we compared three breathing techniques that place different emphasis on inspiratory flow and breath-holding.  Method s : Fourteen healthy older people (69 ± 3.6 yrs) used diaphragmatic breathing (DB), Triflo II (TF), and a water pressure threshold device (BreatheMAX; BM) in a randomized and balanced crossover design. Outcome measures were inspiratory flow and pressure, inspiratory time (Ti), tidal volume (Vt), and breathing frequency.  Results : Inspiratory flow with TF was significantly faster than DB and BM (p < 0.001: 0.96 ± 0.1; 0.43 ± 0.20 and 0.28 ± 0.1 L.s -1 , respectively) and pressures greater (p < 0.001: -1.3 ± 0.6, -5.5 ± 1.2 and -2.8 ± 3.6 cm H 2 O). However, Ti was shorter (TF, 1.16 ± 0.21s; DB, 3.31 ± 0.97 s, p < 0.001; BM, 5.53 ± 1.92 s, p < 0.001), resulting in smaller Vt (TF, 1.12 ± 0.29 L; DB, 1.28 ± 0.29L, p = 0.003; BM, 1.37 ± 0.43L, p = 0.016). Breathing frequency was faster with TF compared to DB and BM (p < 0.001).  Conclusions : Substantial lung inflation could be achieved with any of the above-mentioned methods, although Vt was smaller with TF and the high inspiratory flow with this method may not inflate the lower lung. The high pressures and rapid breathing with TF could increase the sense of effort. Trials are needed to determine the clinical value of the different breathing exercises.",2019,"Inspiratory flow with TF was significantly faster than DB and BM (p < 0.001: 0.96 ± 0.1; 0.43 ± 0.20 and 0.28 ± 0.1 L.s -1 , respectively) and pressures greater (p < 0.001: -1.3 ± 0.6, -5.5 ± 1.2 and -2.8 ± 3.6 cm H 2 O).","['Fourteen healthy older people (69\xa0±\xa03.6\xa0yrs) used', 'healthy older people']","['diaphragmatic breathing (DB), Triflo II (TF), and a water pressure threshold device (BreatheMAX; BM']","['Inspiratory flow with TF', 'breathing patterns, pressure, volume, and flow characteristics', 'Breathing frequency', 'inspiratory flow and pressure, inspiratory time (Ti), tidal volume (Vt), and breathing frequency']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}]","[{'cui': 'C0231898', 'cui_str': 'Diaphragmatic breathing (finding)'}, {'cui': 'C0020309', 'cui_str': 'Hydrostatic Pressure'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0428686', 'cui_str': 'Inspiratory time (observable entity)'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}]",14.0,0.0251075,"Inspiratory flow with TF was significantly faster than DB and BM (p < 0.001: 0.96 ± 0.1; 0.43 ± 0.20 and 0.28 ± 0.1 L.s -1 , respectively) and pressures greater (p < 0.001: -1.3 ± 0.6, -5.5 ± 1.2 and -2.8 ± 3.6 cm H 2 O).","[{'ForeName': 'Chulee', 'Initials': 'C', 'LastName': 'Ubolsakka-Jones', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Wiraporn', 'Initials': 'W', 'LastName': 'Tasangkar', 'Affiliation': 'Physical Therapy Department, Bumrungrad International Hospital, Bangkok, Thailand.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Jones', 'Affiliation': 'School of Health Care Sciences, Manchester Metropolitan University, Manchester, United Kingdom.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1477890']
1409,31523892,"Safety and efficacy of the partial adenosine A1 receptor agonist neladenoson bialanate in patients with chronic heart failure with reduced ejection fraction: a phase IIb, randomized, double-blind, placebo-controlled trial.","AIMS


Neladenoson bialanate is a partial adenosine A1 receptor agonist with demonstrated beneficial effects on cardiac function in animal models. We aimed to assess the dose-response effect of neladenoson bialanate on cardiac structure and function, clinical outcome, and safety in patients with heart failure (HF) with reduced ejection fraction (HFrEF).
METHODS AND RESULTS


PANTHEON was a dose-finding, phase IIb, randomized, double-blind, placebo-controlled trial conducted in 92 centres in 11 countries including 462 patients with chronic HFrEF, randomized to once daily oral dose of neladenoson bialanate (5, 10, 20, 30, and 40 mg) or placebo. The primary endpoints were change from baseline to 20 weeks in left ventricular ejection fraction (LVEF) (echocardiography) and in N-terminal pro-B-type natriuretic peptide (NT-proBNP). Mean age of the patients was 67 years, 17% were female, mean LVEF was 28%, mean NT-proBNP was 2085 ng/L. After 20 weeks of treatment, there was no dose-effect of neladenoson bialanate on changes in NT-proBNP or LVEF (primary endpoints). No effect of neladenoson bialanate was found on left ventricular volumes, high-sensitivity troponin T, or cardiovascular mortality, HF hospitalization, and urgent visits for HF (secondary endpoints). There was a dose-dependent increase in creatinine and cystatin C, and a dose-dependent decrease in estimated glomerular filtration rate and heart rate.
CONCLUSIONS


In patients with chronic HFrEF, treatment with neladenoson bialanate was not associated with dose-dependent favourable effects on cardiac structure and function, cardiac risk markers, or clinical outcome but was associated with a dose-dependent decrease in renal function.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT02992288.",2019,"No effect of neladenoson bialanate was found on left ventricular volumes, high-sensitivity troponin T, or cardiovascular mortality, HF hospitalization, and urgent visits for HF (secondary endpoints).","['92 centres in 11 countries including 462 patients with chronic HFrEF', 'patients with heart failure (HF) with reduced ejection fraction (HFrEF', 'patients with chronic heart failure with reduced ejection fraction', 'Mean age of the patients was 67\u2009years, 17% were female, mean LVEF was 28%, mean NT-proBNP was 2085']","['placebo', 'neladenoson bialanate', 'partial adenosine A1 receptor agonist neladenoson bialanate']","['creatinine and cystatin C', 'Safety and efficacy', 'left ventricular volumes, high-sensitivity troponin T, or cardiovascular mortality, HF hospitalization, and urgent visits for HF (secondary endpoints', 'cardiac structure and function, clinical outcome, and safety', 'renal function', 'estimated glomerular filtration rate and heart rate', 'change from baseline to 20\u2009weeks in left ventricular ejection fraction (LVEF) (echocardiography) and in N-terminal pro-B-type natriuretic peptide (NT-proBNP', 'cardiac structure and function, cardiac risk markers']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4519331', 'cui_str': 'neladenoson bialanate'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C2936550', 'cui_str': 'Adenosine A1 Receptor Agonists'}]","[{'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for (contextual qualifier) (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C3811844'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",462.0,0.557535,"No effect of neladenoson bialanate was found on left ventricular volumes, high-sensitivity troponin T, or cardiovascular mortality, HF hospitalization, and urgent visits for HF (secondary endpoints).","[{'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jeroen J', 'Initials': 'JJ', 'LastName': 'Bax', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Antonieta B', 'Initials': 'AB', 'LastName': 'Wirtz', 'Affiliation': 'Bayer AG, Leverkusen, Germany.'}, {'ForeName': 'Akos F', 'Initials': 'AF', 'LastName': 'Pap', 'Affiliation': 'Bayer AG, Leverkusen, Germany.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Ferreira', 'Affiliation': 'Bayer AG, Leverkusen, Germany.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'van der Laan', 'Affiliation': 'Bayer AG, Leverkusen, Germany.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1591']
1410,31647379,Communicating Dynamic Behaviors in Basketball: The Role of Verbal Instructions and Arrow Symbols.,"Purpose:  Guided by cognitive load theory and cognitive theory of multimedia learning, the purpose of this study was to evaluate players' ability to integrate dynamic information presented under different conditions: a verbal condition, in which instructions were given orally; a visual condition, in which instructions were shown using arrow symbols; and a redundant condition, in which both visual and verbal instructions were presented simultaneously.  Method:  In a 2 × 3 design, we asked basketball players with varied levels of skill (less-skilled, skilled) to rate their invested mental effort and to perform a recall test after learning from either the verbal, visual or redundant condition.  Results:  Results demonstrated that the less-skilled players benefited more from the redundant condition, whereas the skilled participants benefited more from the visual condition.  Conclusion:  Recommendations for improving instructional design techniques aimed at the transmission of tactical instructions in team games are proposed.",2020,"Results demonstrated that the less-skilled players benefited more from the redundant condition, whereas the skilled participants benefited more from the visual condition.  ",['Basketball'],"['basketball players with varied levels of skill (less-skilled, skilled) to rate their invested mental effort and to perform a recall test after learning from either the verbal, visual or redundant condition', 'cognitive load theory and cognitive theory of multimedia learning']",[],"[{'cui': 'C0004818', 'cui_str': 'Basketball'}]","[{'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}]",[],,0.0237597,"Results demonstrated that the less-skilled players benefited more from the redundant condition, whereas the skilled participants benefited more from the visual condition.  ","[{'ForeName': 'Aïmen', 'Initials': 'A', 'LastName': 'Khacharem', 'Affiliation': 'Paris-East Créteil University.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Trabelsi', 'Affiliation': 'University of Sfax.'}, {'ForeName': 'Bachir', 'Initials': 'B', 'LastName': 'Zoudji', 'Affiliation': 'University of Polytechnique Hautes-de-France.'}, {'ForeName': 'Slava', 'Initials': 'S', 'LastName': 'Kalyuga', 'Affiliation': 'University of New South Wales.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2019.1657553']
1411,31634648,UCBG 2-04: Long-term results of the PACS 04 trial evaluating adjuvant epirubicin plus docetaxel in node-positive breast cancer and trastuzumab in the human epidermal growth factor receptor 2-positive subgroup.,"PURPOSE


We conducted a double-randomised phase III trial to evaluate a concomitant taxane-anthracycline regimen in node-positive breast cancer and the efficacy of trastuzumab in the human epidermal growth factor receptor 2 (HER2)-positive subpopulation.
METHODS


A total of 3010 patients with node-positive breast cancer were randomly assigned to receive 6 cycles of 500 mg/m 2  of fluorouracil, 100 mg/m 2  of epirubicin and 500 mg/m 2  of cyclophosphamide (FEC) or 75 mg/m 2  of epirubicin and 75 mg/m 2  of docetaxel (ED). Patients with HER2-positive tumours were secondary randomly assigned to either trastuzumab or observation. The primary end-point was disease-free survival (DFS) in the two chemotherapy arms.
RESULTS


After a 115-month median follow-up, DFS was not significantly better in the ED arm (DFS: 70%, 95% confidence interval [CI]: 67-72) than in the FEC arm (DFS: 68%, 95% CI: 65-70; hazard ratio [HR] = 0.88, 95% CI: 0.77-1.01; p = 0.064). The OS was not different between FEC (OS: 80%, 95% CI: 78-83) and ED (OS: 81%, 95% CI: 79-83); HR = 0.97, 95% CI: 0.81-1.16; p = 0.729). ED appeared more toxic. In the 528 HER2-positive subset, there was trend for a higher DFS, in the intention-to-treat population, in the trastuzumab arm (DFS: 68%, 95% CI: 61-74) than in the observation arm (DFS: 60%, 95% CI: 54-66; HR = 0.77, 95% CI: 0.57-1.03; p = 0.079). In the per-protocol population, DFS was significantly higher in the trastuzumab arm (DFS: 70%, 95% CI: 63-76) than in the observation arm (DFS: 59%, 95% CI: 53-65; HR = 0.69, 95% CI: 0.51-0.94; p = 0.0156). The OS was not different between these 2 arms.
CONCLUSION


This study did not show superiority of the concomitant anthracycline-taxane arm which was more toxic in high-risk node-positive breast cancer patients. Long-term results of the HER2-positive subpopulation are in line with those of the other adjuvant trastuzumab trials but quantitatively less pronounced mostly because of lack of power.",2019,"The OS was not different between FEC (OS: 80%, 95% CI: 78-83) and ED (OS: 81%, 95% CI: 79-83); HR = ","['Patients with HER2-positive tumours', 'high-risk node-positive breast cancer patients', 'node-positive breast cancer', '3010 patients with node-positive breast cancer', 'node-positive breast cancer and trastuzumab in the human epidermal growth factor receptor 2-positive subgroup']","['trastuzumab or observation', 'fluorouracil,\xa0100\xa0mg/m 2  of epirubicin and\xa0500\xa0mg/m 2  of cyclophosphamide (FEC) or 75', 'concomitant taxane-anthracycline regimen', 'trastuzumab', 'epirubicin plus docetaxel', 'concomitant anthracycline-taxane', 'epirubicin and 75\xa0mg/m 2  of docetaxel (ED']","['disease-free survival (DFS', 'DFS', 'toxic']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C3160887', 'cui_str': 'Node-positive breast cancer'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",3010.0,0.18372,"The OS was not different between FEC (OS: 80%, 95% CI: 78-83) and ED (OS: 81%, 95% CI: 79-83); HR = ","[{'ForeName': 'Véronique', 'Initials': 'V', 'LastName': ""D'Hondt"", 'Affiliation': 'Medical Oncology Department, Institut du Cancer, IRCM, INSERM, Univ Montpellier, France. Electronic address: veronique.dhondt@icm.unicancer.fr.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Canon', 'Affiliation': 'Medical Oncology Department, Clinique Notre Dame, Charleroi, Belgium.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Roca', 'Affiliation': 'Biometrics Unit, Institut du Cancer, Montpellier, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': 'Medical Oncology Department, Centre François Baclesse, Caen, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Pierga', 'Affiliation': 'Medical Oncology Department, Institut Curie & St Cloud, Université Paris Descartes, Paris, France.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Le Du', 'Affiliation': 'Medical Oncology Department, Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': ""Medical Oncology Department, Institut de Cancérologie de l'Ouest, Saint-Herblain, France.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Desmoulins', 'Affiliation': 'Medical Oncology Department, Centre Georges-François Leclerc, Dijon, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Goncalves', 'Affiliation': 'Medical Oncology Department, Institut Paoli-Calmettes, Marseille, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Debled', 'Affiliation': 'Medical Oncology Department, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rios', 'Affiliation': 'Medical Oncology Department, Institut de Cancérologie de Lorraine - Alexis Vautrin, Vandoeuvre-Les-Nancy, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Ferrero', 'Affiliation': 'Medical Oncology Department, Centre Antoine Lacassagne, Nice, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Serin', 'Affiliation': 'Medical Oncology Department, Institut Sainte-Catherine, Avignon, France.'}, {'ForeName': 'Anne-Claire', 'Initials': 'AC', 'LastName': 'Hardy-Bessard', 'Affiliation': ""Medical Oncology Department, Centre Armoricain de Radiothérapie, d'Imagerie et d'Oncologie, Plérin, France.""}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Piot', 'Affiliation': 'Medical Oncology Department, Centre-Médico Chirurgical Les Ormeaux, Le Havre, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Brain', 'Affiliation': 'Medical Oncology Department, Institut Curie, Centre René Huguenin, Saint-Cloud, France.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Dohollou', 'Affiliation': 'Medical Oncology Department, Polyclinique Bordeaux Nord Aquitaine, Bordeaux, France.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Orfeuvre', 'Affiliation': 'Medical Oncology Department, CH - Hôpital de Fleyriat, Bourg-en-Bresse, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Lemonnier', 'Affiliation': 'UCBG, R&D UNICANCER, Paris, France.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Roché', 'Affiliation': 'Medical Oncology Department, IUCT Claudius Regaud, Toulouse, France.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Delaloge', 'Affiliation': 'Medical Oncology Department, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Dalenc', 'Affiliation': 'Medical Oncology Department, IUCT Claudius Regaud, Toulouse, France.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.09.014']
1412,32411025,Memory Retrieval-Extinction Combined With Virtual Reality Reducing Drug Craving for Methamphetamine: Study Protocol for a Randomized Controlled Trial.,"Background


Relapse, often precipitated by drug-associated cues that evoke craving, is a key problem in the treatment of methamphetamine use disorder (MUD). Drug-associated memories play a major role in the maintenance of relapse. Extinction training is a common method for decreasing drug craving by suppressing drug-associated memories. However, the effects are often not permanent, which is evident in form of spontaneous recovery or renewal of cue-elicited responses. Based on memory reconsolidation theory, the retrieval-extinction (R-E) paradigm may be more effective in decreasing spontaneous recovery or renewal responses than extinction. After the original memory reactivated to a labile state, extinction will be introduced within the reconsolidation window, thereby updating drug-associated memories. However, there are still some controversial results, which suggest that the reactivation of drug-associated memories and the 10 min-6 h of limited time window are two main elements in the R-E protocol. Virtual reality (VR) is supposed to promote memory reactivation by providing vivid drug-related stimuli when compared with movies.
Objective


The aim of this study is to examine the effectiveness of R-E training combined with VR on reducing spontaneous recovery or renewal of cue-elicited responses, in comparison to extinction, R-E training provided outside the time window of 6 h and R-E training retrieved using videos, in methamphetamine abusers.
Methods


The study is a parallel matched controlled study including 95 participants with MUD. Participants will be randomly assigned to either a R-10 min-E group (methamphetamine-related cues retrieval in VR followed by extinction after 10 min) or a NR-10 min-E group (neutral cues retrieval in VR followed by extinction after 10 min) or a R-6 h-E group (methamphetamine-related cues retrieval in VR followed by extinction after 6 h) or a RV-10 min-E group (methamphetamine-related cues retrieval in videos followed by extinction after 10 min). Cue-evoked craving and reactivity will be assessed at pre-test and at 1 day, 1 week, 1 month, and 6-month post-tests.
Discussion


To our knowledge, this study will probably be the first study to examine the efficacy of R-E training combined with VR to reduce cue-evoked responses in people with MUD. This innovative non-pharmacological intervention targeting drug-associated memories may provide significant clinical implications for reducing relapse, providing the study confirms its efficacy.
Clinical Trial Registration


The trial is registered with Chinese Clinical Trial Registry at 17 October 2018, number: ChiCTR1800018899, URL: http://www.chictr.org.cn/showproj.aspx?proj=30854.",2020,Participants will be randomly assigned to either a R-10 min-E group (methamphetamine-related cues retrieval in VR followed by extinction after 10 min) or a NR-10 min-E group (neutral cues retrieval in VR followed by extinction after 10 min) or a R-6 h-E group (methamphetamine-related cues retrieval in VR followed by extinction after 6 h) or a RV-10 min-E group (methamphetamine-related cues retrieval in videos followed by extinction after 10 min).,"['95 participants with MUD', 'methamphetamine abusers', 'people with MUD']","['R-E training combined with VR', 'R-10 min-E group (methamphetamine-related cues retrieval in VR followed by extinction after 10 min) or a NR-10 min-E group (neutral cues retrieval in VR followed by extinction after 10 min) or a R-6 h-E group (methamphetamine-related cues retrieval in VR followed by extinction after 6 h) or a RV-10 min-E group (methamphetamine-related cues retrieval in videos followed by extinction', 'Methamphetamine', 'Memory Retrieval-Extinction Combined With Virtual Reality', 'Extinction training', 'Virtual reality (VR']","['drug craving', 'Cue-evoked craving and reactivity']","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]","[{'cui': 'C0556446', 'cui_str': 'Craves for drugs'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",95.0,0.0818371,Participants will be randomly assigned to either a R-10 min-E group (methamphetamine-related cues retrieval in VR followed by extinction after 10 min) or a NR-10 min-E group (neutral cues retrieval in VR followed by extinction after 10 min) or a R-6 h-E group (methamphetamine-related cues retrieval in VR followed by extinction after 6 h) or a RV-10 min-E group (methamphetamine-related cues retrieval in videos followed by extinction after 10 min).,"[{'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Key Laboratory of Mental Health, Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Xi-Jing', 'Initials': 'XJ', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Mental Health, Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Ya-Tong', 'Initials': 'YT', 'LastName': 'Wen', 'Affiliation': 'Key Laboratory of Mental Health, Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Markus H', 'Initials': 'MH', 'LastName': 'Winkler', 'Affiliation': 'Department of Psychology I, Biological Psychology, Clinical Psychology, and Psychotherapy, University of Wurzburg, Wurzburg, Germany.'}, {'ForeName': 'Pauli', 'Initials': 'P', 'LastName': 'Paul', 'Affiliation': 'Department of Psychology I, Biological Psychology, Clinical Psychology, and Psychotherapy, University of Wurzburg, Wurzburg, Germany.'}, {'ForeName': 'Yi-Ling', 'Initials': 'YL', 'LastName': 'He', 'Affiliation': ""Center for Mental Health, Women's Drug Rehabilitation Center of Guangdong Province, Foshan, China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Mental Health, Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Hong-Xian', 'Initials': 'HX', 'LastName': 'Chen', 'Affiliation': 'Mental Health Institute, Second Xiangya Hospital, Central South Universit\u2006y, Changsha, China.'}, {'ForeName': 'Yong-Hui', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Mental Health, Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00322']
1413,31640924,Feasibility and effect of a physical activity counselling session with or without provision of an activity tracker on maintenance of physical activity in women with breast cancer - A randomised controlled trial.,"OBJECTIVES


The SAFE-Maintain study sought to evaluate the effect and acceptability of a physical activity counselling (PAC) session, versus a PAC session plus provision of a Fitbit (Charge HR®; PAC+F), on maintenance of physical activity levels 12 weeks following participation in a supervised exercise intervention.
DESIGN


Fifty-two women with stage II+breast cancer who had recently (within the previous 7 days) completed a 12-week supervised exercise program were randomised to the PAC or PAC+F group.
METHODS


Physical activity levels, including weekly minutes of total physical activity (min/week), daily step count (steps/day), and weekly minutes of moderate to vigorous physical activity (MVPA, min/week), were assessed using the Active Australia survey and Actigraph® GT3X+ accelerometers. Self-reported outcomes were assessed at baseline and 12-week follow-up, while objectively-measured outcomes were only available at 12-week follow-up.
RESULTS


Compared with the PAC group, the PAC+F group had higher self-reported MVPA and self-reported total activity (between-group mean difference: 78.2 [95% CI=-8.3, 164.9] min/week, p<0.01, and 171.9 [95% CI=46.1, 297.8] min/week, p<0.01, respectively) at 12-week follow-up. Higher objectively-assessed MVPA (p=0.03) and steps/day (p=0.07) at 12-week follow-up was also observed in the PAC+F group compared with the PAC group. Most (>80%) of the PAC+F group reported high levels of Fitbit use and considered the device to be beneficial for physical activity maintenance.
CONCLUSIONS


Findings suggest that activity trackers show promise as an effective, feasible and acceptable approach to support physical activity maintenance following completion of a supervised exercise intervention.
TRIAL REGISTRATION


Prospectively registered on the Australian and New Zealand Clinical Trials Registry (ANZCTR, Trial registration number: ACTRN12616000954426).",2020,Higher objectively-assessed MVPA (p=0.03) and steps/day (p=0.07) at 12-week follow-up was also observed in the PAC+F group compared with the PAC group.,"['women with breast cancer ', 'Fifty-two women with stage II+breast cancer who had recently (within the previous 7 days) completed a 12-week']","['PAC+F', 'physical activity counselling (PAC) session', 'PAC session plus provision of a Fitbit (Charge HR®; PAC+F', 'supervised exercise program', 'physical activity counselling session with or without provision of an activity tracker', 'PAC or PAC+F', 'PAC']","['higher self-reported MVPA and self-reported total activity', 'total physical activity (min/week), daily step count (steps/day), and weekly minutes of moderate to vigorous physical activity (MVPA, min/week', 'physical activity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0182281', 'cui_str': 'Picture Archiving and Communication Systems'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0556975', 'cui_str': 'mins/week'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]",52.0,0.0759557,Higher objectively-assessed MVPA (p=0.03) and steps/day (p=0.07) at 12-week follow-up was also observed in the PAC+F group compared with the PAC group.,"[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': 'School of Public Health and Social Work, Queensland University of Technology, Australia; Institute of Health and Biomedical Innovation, Queensland University of Technology, Australia. Electronic address: benjmain.singh@hdr.qut.edu.au.'}, {'ForeName': 'Rosalind R', 'Initials': 'RR', 'LastName': 'Spence', 'Affiliation': 'School of Public Health and Social Work, Queensland University of Technology, Australia; Institute of Health and Biomedical Innovation, Queensland University of Technology, Australia.'}, {'ForeName': 'Carolina X', 'Initials': 'CX', 'LastName': 'Sandler', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, Australia; School of Exercise and Nutrition Science, Queensland University of Technology, Australia; UNSW Fatigue Clinic, Faculty of Medicine, University of New South Wales, Australia; School of Public Health, The University of Queensland, Australia.'}, {'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Tanner', 'Affiliation': 'School of Public Health and Social Work, Queensland University of Technology, Australia; Institute of Health and Biomedical Innovation, Queensland University of Technology, Australia.'}, {'ForeName': 'Sandra C', 'Initials': 'SC', 'LastName': 'Hayes', 'Affiliation': 'Griffith University, Menzies Health Institute Queensland, Australia.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2019.09.019']
1414,31834062,"Online Family Problem-Solving Therapy (F-PST) for Executive and Behavioral Dysfunction After Traumatic Brain Injury in Adolescents: A Randomized, Multicenter, Comparative Effectiveness Clinical Trial.","OBJECTIVE


To examine the comparative effectiveness of 3 modes of family problem-solving therapy (F-PST): therapist-guided online, self-guided online, and face-to-face.
SETTING


Four children's hospitals and a general hospital with pediatric commitment.
PARTICIPANTS


A total of 150 adolescents aged 14 to 18 years, previously hospitalized with traumatic brain injury (TBI), and evidence of behavior problems at enrollment.
DESIGN


Multicenter, randomized clinical trial.
MAIN MEASURES


Behavior Rating Inventory of Executive Function (BRIEF) Global Executive Composite (GEC), Behavior Regulation Index, and Metacognition Index, and Strengths and Difficulties Questionnaire (SDQ) Total at baseline and 6 and 9 months later.
RESULTS


Mixed-model intention-to-treat analyses of comparative effectiveness failed to reveal statistically significant differences among treatment groups. At 6 months, parent BRIEF-GEC improved for the therapist-guided and self-guided, online groups. Effects remained significant and increased in magnitude at 9 months for the self-guided online group. Scores for the Self-guided online group significantly improved from baseline to 9 months on the SDQ Total.
CONCLUSIONS


This comparative effectiveness study supports the utility of both self- and therapist-guided online F-PST in improving executive function behaviors in adolescents following TBI. Further work regarding clinical implementation and how best to integrate telehealth with ongoing rehabilitation care is warranted.",2020,This comparative effectiveness study supports the utility of both self- and therapist-guided online F-PST in improving executive function behaviors in adolescents following TBI.,"['A total of 150 adolescents aged 14 to 18 years, previously hospitalized with traumatic brain injury (TBI), and evidence of behavior problems at enrollment', 'Adolescents', 'adolescents following TBI', ""Four children's hospitals and a general hospital with pediatric commitment""]","['self- and therapist-guided online F-PST', 'Online Family Problem-Solving Therapy (F-PST', 'family problem-solving therapy (F-PST): therapist-guided online, self-guided online, and face-to-face']","['Executive and Behavioral Dysfunction', 'Behavior Rating Inventory of Executive Function (BRIEF', 'executive function behaviors', 'Global Executive Composite (GEC), Behavior Regulation Index, and Metacognition Index, and Strengths and Difficulties Questionnaire (SDQ) Total', 'parent BRIEF-GEC']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0424960', 'cui_str': 'Family problems (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]","[{'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0589513', 'cui_str': 'Meta-cognition'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]",150.0,0.091132,This comparative effectiveness study supports the utility of both self- and therapist-guided online F-PST in improving executive function behaviors in adolescents following TBI.,"[{'ForeName': 'Brad G', 'Initials': 'BG', 'LastName': 'Kurowski', 'Affiliation': ""Division of Pediatric Rehabilitation Medicine, Departments of Pediatrics and Neurology and Rehabilitation Medicine (Dr Kurowski), Division of Epidemiology and Biostatistics, Department of Pediatrics (Dr Cassedy), Division of Neurology, Department of Pediatrics (Dr Horn), and Division of Pediatric Rehabilitation Medicine, Department of Pediatrics (Dr Wade), Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Ohio; Biobehavioral Health Center, Abigail Wexner Research Institute at Nationwide Children's Hospital and The Ohio State University, Columbus, and Case Western Reserve University and Rainbow Babies & Children's Hospital, University Hospitals Cleveland Medical Center, Cleveland, Ohio (Dr Taylor); Nationwide Children's Hospital and The Ohio State University, Columbus, Ohio (Dr McNally); Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, Colorado (Dr Kirkwood); and MetroHealth Medical Center and Case Western Reserve University, Cleveland, Ohio (Dr Stancin).""}, {'ForeName': 'H Gerry', 'Initials': 'HG', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'McNally', 'Affiliation': ''}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Kirkwood', 'Affiliation': ''}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cassedy', 'Affiliation': ''}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Horn', 'Affiliation': ''}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Stancin', 'Affiliation': ''}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Wade', 'Affiliation': ''}]",The Journal of head trauma rehabilitation,['10.1097/HTR.0000000000000545']
1415,32411024,"Feasibility and Acceptability of a Student-Led Lifestyle (Diet and Exercise) Intervention Within a Residential Rehabilitation Setting for People With Severe Mental Illness, GO HEART (Group Occupation, Health, Exercise And Rehabilitation Treatment).","Purpose


People with severe mental illness (SMI) experience poor physical health and premature mortality, contributed significantly by modifiable lifestyle risk factors such as poor nutrition, low cardiorespiratory fitness, and physical inactivity. Lifestyle interventions can reduce cardiometabolic risk and confer a range of other positive mental and physical health benefits. We assessed the feasibility, acceptability, safety, and preliminary effectiveness of a lifestyle (combined dietary and exercise) intervention lead by senior exercise and dietetics students in a residential mental health rehabilitation setting.
Design


Single arm, prospective study evaluating outcomes pre and post a 10-week dietary and exercise intervention.
Method


People with SMI from three residential rehabilitation units participated in a mixed aerobic and resistance training exercise intervention three times per week that was combined with a dietary intervention (six individual and group sessions). Primary outcome considerations were feasibility (recruitment, retention, and participation rates), acceptability, and adverse events. Secondary outcomes were preliminary effectiveness; (functional exercise capacity, volume of exercise, and metabolic markers), psychiatric symptoms, quality of life, and attitudes to exercise.
Results


Forty-two participants were recruited (92% primary diagnosis of schizophrenia). Intervention feasibility was supported by high levels of recruitment (68%), retention (77%), and participation (70% exercise, 65% diet sessions); and the absence of serious adverse events. Significant improvements in functional exercise capacity, volume of exercise, general psychiatric symptoms, and negative psychotic symptoms occurred. Anthropometric and metabolic blood markers did not change. While the intervention was acceptable to participants, motivation for and perceived value of exercise reduced over 10 weeks.
Conclusions


A brief pragmatic student-led lifestyle intervention integrated into usual mental health care was feasible, acceptable, safe, and scalable across two additional mental health residential rehabilitation sites, and resulted in physical and mental health improvements. Increased frequency of dietary sessions and length of dietary intervention may improve metabolic outcomes in the future. People with SMI living in residential rehabilitation units should have access to lifestyle programs to address modifiable lifestyle risk factors. While this brief intervention was feasible and acceptable, this study highlights some of the challenges associated with maintaining motivation for healthy lifestyles for people with SMI. Longer term investigation of real-world lifestyle interventions is warranted, together with additional interventions that may support people with SMI to sustain motivation to address lifestyle factors.
Clinical Trial Registration


The trial was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), Unique Identifier: ACTRN 12618000478213, http://www.anzctr.org.au Universal trial number (UTN)-U1111-1211-4009.",2020,People with SMI living in residential rehabilitation units should have access to lifestyle programs to address modifiable lifestyle risk factors.,"['Forty-two participants were recruited (92% primary diagnosis of schizophrenia', 'People with SMI living in residential rehabilitation units', 'People with severe mental illness (SMI', 'healthy lifestyles for people with SMI', 'and dietetics students in a residential mental health rehabilitation setting', 'Method\n\n\nPeople with SMI from three residential rehabilitation units participated in a', 'People With Severe Mental Illness']","['dietary and exercise intervention', 'Lifestyle interventions', 'lifestyle (combined dietary and exercise) intervention lead by senior exercise', 'Intervention', 'Student-Led Lifestyle (Diet and Exercise', 'mixed aerobic and resistance training exercise intervention']","['Anthropometric and metabolic blood markers', 'feasibility, acceptability, safety', 'feasibility (recruitment, retention, and participation rates), acceptability, and adverse events', 'effectiveness; (functional exercise capacity, volume of exercise, and metabolic markers), psychiatric symptoms, quality of life, and attitudes to exercise', 'absence of serious adverse events', 'functional exercise capacity, volume of exercise, general psychiatric symptoms, and negative psychotic symptoms', 'cardiometabolic risk', 'metabolic outcomes', 'Feasibility and Acceptability']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0204512', 'cui_str': 'Psychiatric rehabilitation'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",42.0,0.0823209,People with SMI living in residential rehabilitation units should have access to lifestyle programs to address modifiable lifestyle risk factors.,"[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Korman', 'Affiliation': 'Addiction and Mental Health Services, Metro South Health Services, Brisbane, QLD, Australia.'}, {'ForeName': 'Harley', 'Initials': 'H', 'LastName': 'Fox', 'Affiliation': 'School of Medicine, University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Skinner', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Dodd', 'Affiliation': 'Addiction and Mental Health Services, Metro South Health Services, Brisbane, QLD, Australia.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Suetani', 'Affiliation': 'Addiction and Mental Health Services, Metro South Health Services, Brisbane, QLD, Australia.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Chapman', 'Affiliation': 'Addiction and Mental Health Services, Metro South Health Services, Brisbane, QLD, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Parker', 'Affiliation': 'Addiction and Mental Health Services, Metro South Health Services, Brisbane, QLD, Australia.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Dark', 'Affiliation': 'Addiction and Mental Health Services, Metro South Health Services, Brisbane, QLD, Australia.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Collins', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Rosenbaum', 'Affiliation': 'School of Psychiatry, Faculty of Medicine, UNSW, Sydney, NSW, Australia.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Siskind', 'Affiliation': 'Addiction and Mental Health Services, Metro South Health Services, Brisbane, QLD, Australia.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00319']
1416,31642350,Editor's Choice: Consistency tendency and the theory of planned behavior: a randomized controlled crossover trial in a physical activity context.,"Objective:  This study examined the effects of consistency tendency on the predictive power of the theory of planned behavior (TPB) in relation to physical activity behavior. Methods:  In this randomized controlled cross-over trial, we recruited 770 undergraduate students from Indonesia who were randomly assigned into two groups. Participants completed physical activity versions of TPB measures at T1 (baseline) and T2 (post 1 week), and the International Physical Activity Questionnaire at T3 (post 1 month). At T1 and T2, the TPB questions were either presented in ensemble-order (i.e., consistency tendency supressed) or alternate-order (i.e., consistency tendency facilitated). Results:  The parameter estimates of the model (CFI > .92, TLI > .90, SRMR < .08, RMSEA < .08) aligned with the tenets of TPB. As compared to ensemble-order, a TPB measured in alternate-order yielded stronger cross-sectional relationships, but this pattern did not appear in the prospective relationships in TPB (i.e., intention/perceived behavioral control and behavior). Conclusions:  Consistency tendency inflated the factor correlations of cross-sectionally measured TPB variables, but the inflation was not observed in the prospective prediction of behavior. Health psychology questionnaires with items presented in ensemble order may represent a viable means of reducing the confounding effect of consistency tendency.",2020,"As compared to ensemble-order, a TPB measured in alternate-order yielded stronger cross-sectional relationships, but this pattern did not appear in the prospective relationships in TPB (i.e., intention/perceived behavioral control and behavior).  ",['770 undergraduate students from Indonesia who were randomly assigned into two groups'],['planned behavior (TPB'],"['physical activity versions of TPB measures', 'International Physical Activity Questionnaire']","[{'cui': 'C4517873', 'cui_str': '770'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0021247', 'cui_str': 'East Indies'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",770.0,0.0292494,"As compared to ensemble-order, a TPB measured in alternate-order yielded stronger cross-sectional relationships, but this pattern did not appear in the prospective relationships in TPB (i.e., intention/perceived behavioral control and behavior).  ","[{'ForeName': 'Derwin K C', 'Initials': 'DKC', 'LastName': 'Chan', 'Affiliation': 'Faculty of Education and Human Development, The Education University of Hong Kong, New Territories, Hong Kong.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Stenling', 'Affiliation': 'University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Cleoputri', 'Initials': 'C', 'LastName': 'Yusainy', 'Affiliation': 'Department of Psychology, Brawijaya University, Malang, Indonesia.'}, {'ForeName': 'Ziadatul', 'Initials': 'Z', 'LastName': 'Hikmiah', 'Affiliation': 'Department of Psychology, Brawijaya University, Malang, Indonesia.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ivarsson', 'Affiliation': 'School of Health and Welfare, Halmstad University, Halmstad, Sweden.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Hagger', 'Affiliation': 'University of California, Merced, CA, USA.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Rhodes', 'Affiliation': 'Health and Physical Education, University of Victoria, Victoria, BC, Canada.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Beauchamp', 'Affiliation': 'University of British Columbia, Vancouver, BC, Canada.'}]",Psychology & health,['10.1080/08870446.2019.1677904']
1417,31638838,Nutritional factors influencing plasma adiponectin levels: results from a randomised controlled study with whole-grain cereals.,"Data from intervention studies about the effects of a high intake of whole-grain cereals on adiponectin expression are still inconclusive. We evaluated the effects of whole-grain or refined cereals on fasting and postprandial serum adiponectin in people at high cardiovascular risk. According to a randomised controlled parallel group design, participants with metabolic syndrome were assigned to an isoenergetic diet based on either whole-grain cereal (WGC) or refined cereal (RC) products for 12-weeks. Anthropometric and biochemical measures were taken. Compared to baseline, fasting and postprandial serum adiponectin levels increased after both RC and WGC. In the WGC and RC groups combined, adiponectin concentrations significantly increased after 12-week intervention, and are directly associated with plasma SCFAs and acetate. Only increasing whole-grain cereals may not influence adiponectin levels, which could be modified by a fibre rich, low-fat, low-glycemic index diet, possibly through changes in gut microbiota, as suggested by the relation with SCFAs.Clinical Trials number: NCT00945854.",2020,"In the WGC and RC groups combined, adiponectin concentrations significantly increased after 12-week intervention, and are directly associated with plasma SCFAs and acetate.","['participants with metabolic syndrome', 'people at high cardiovascular risk']","['isoenergetic diet based on either whole-grain cereal (WGC) or refined cereal (RC) products for 12-weeks', 'whole-grain or refined cereals']","['fasting and postprandial serum adiponectin levels', 'plasma adiponectin levels', 'adiponectin expression', 'adiponectin concentrations']","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4046096', 'cui_str': 'Whole Grain Cereals'}, {'cui': 'C0007757', 'cui_str': 'Cereal Grain'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",,0.0194812,"In the WGC and RC groups combined, adiponectin concentrations significantly increased after 12-week intervention, and are directly associated with plasma SCFAs and acetate.","[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Polito', 'Affiliation': 'CEINGE-Biotecnologie avanzate, Napoli, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Costabile', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Napoli, Italy.'}, {'ForeName': 'Ersilia', 'Initials': 'E', 'LastName': 'Nigro', 'Affiliation': 'CEINGE-Biotecnologie avanzate, Napoli, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Giacco', 'Affiliation': 'Institute of Food Science, National Research Council, Avellino, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Vetrani', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Napoli, Italy.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Anniballi', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Napoli, Italy.'}, {'ForeName': 'Delia', 'Initials': 'D', 'LastName': 'Luongo', 'Affiliation': 'CNR-Institute of Biostructures and Bioimaging, Napoli, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Riccardi', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Napoli, Italy.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Daniele', 'Affiliation': 'CEINGE-Biotecnologie avanzate, Napoli, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Annuzzi', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Napoli, Italy.'}]",International journal of food sciences and nutrition,['10.1080/09637486.2019.1680959']
1418,29803635,Enhanced Striatal Dopamine Release to Expectation of Alcohol: A Potential Risk Factor for Alcohol Use Disorder.,"BACKGROUND


We used positron emission tomography imaging with [ 11 C]raclopride to examine the effects of consumption of alcohol or placebo beverage by participants with alcohol use disorder (AUD) compared with healthy participants with and without family history of AUD. We sought to assess dopamine release following alcohol exposure in relation to AUD risk.
METHODS


Three groups were enrolled: participants with AUD (n = 15) and healthy participants with family history negative (n = 34) or positive (n = 16) for AUD. Participants consumed a placebo (n = 65) or alcohol (n = 63) beverage in counterbalanced order before positron emission tomography scanning (128 scans). Binding potential (BP ND ) in the two drink conditions and the percent change in BP ND  between conditions were evaluated across striatal subregions. Subjective effects of beverage consumption were rated. Effects of group, drink order, and sex were evaluated.
RESULTS


Alcohol resulted in greater dopamine release than did placebo in the ventral striatum (p < .001). There were no main effects of group, drink order, or sex on ventral striatum BP ND  or percent change in BP ND . However, there was a drink order-by-group interaction (p = .02) whereby family history-positive participants who received placebo first had both lower placebo BP ND  and less difference between placebo and alcohol BP ND  than all other groups, consistent with expectation of alcohol powerfully evoking dopamine release in this group. Subjective responses showed the same order-by-group interaction.
CONCLUSIONS


Hyper-responsivity of the dopaminergic system in family history-positive participants to expectation of alcohol may contribute to the expression of familial risk for AUD.",2018,"RESULTS


Alcohol resulted in greater dopamine release than did placebo in the ventral striatum (p < .001).","['Three groups were enrolled: participants with AUD (n\xa0= 15) and healthy participants with family history negative (n\xa0= 34) or positive (n\xa0= 16) for AUD', 'participants with alcohol use disorder (AUD) compared with healthy participants with and without family history of AUD']","['positron emission tomography imaging', 'placebo', 'alcohol or placebo', 'alcohol (n\xa0= 63) beverage in counterbalanced order before positron emission tomography scanning', 'Alcohol']","['drink order, or sex on ventral striatum BP ND  or percent change in BP ND ', 'dopamine release', 'Binding potential (BP ND ', 'Subjective responses']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0241889', 'cui_str': 'Family Medical History'}]","[{'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]","[{'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0750950', 'cui_str': 'Ventral Striatum'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",,0.1167,"RESULTS


Alcohol resulted in greater dopamine release than did placebo in the ventral striatum (p < .001).","[{'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Kegeles', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and the New York State Psychiatric Institute, New York, New York; Department of Radiology, Columbia University College of Physicians and Surgeons, New York, New York. Electronic address: lsk5@columbia.edu.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Horga', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and the New York State Psychiatric Institute, New York, New York.'}, {'ForeName': 'Rassil', 'Initials': 'R', 'LastName': 'Ghazzaoui', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and the New York State Psychiatric Institute, New York, New York.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Rosengard', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and the New York State Psychiatric Institute, New York, New York.'}, {'ForeName': 'Najate', 'Initials': 'N', 'LastName': 'Ojeil', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and the New York State Psychiatric Institute, New York, New York.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and the New York State Psychiatric Institute, New York, New York.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Slifstein', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and the New York State Psychiatric Institute, New York, New York.'}, {'ForeName': 'Ismene', 'Initials': 'I', 'LastName': 'Petrakis', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Anissa', 'Initials': 'A', 'LastName': 'Abi-Dargham', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and the New York State Psychiatric Institute, New York, New York; Department of Radiology, Columbia University College of Physicians and Surgeons, New York, New York.'}]",Biological psychiatry. Cognitive neuroscience and neuroimaging,['10.1016/j.bpsc.2018.03.018']
1419,32411028,Commentary: Studying a Possible Placebo Effect of an Imaginary Low-Calorie Diet.,,2020,,[],['Imaginary Low-Calorie Diet'],[],[],"[{'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}]",[],,0.0703368,,"[{'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Dickinson', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Indiana University Bloomington, Bloomington, IN, United States.'}, {'ForeName': 'Greyson', 'Initials': 'G', 'LastName': 'Foote', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Indiana University Bloomington, Bloomington, IN, United States.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Allison', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Indiana University Bloomington, Bloomington, IN, United States.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00329']
1420,31588356,"Protocol for the electroencephalography guidance of anesthesia to alleviate geriatric syndromes (ENGAGES-Canada) study: A pragmatic, randomized clinical trial.","Background:   There is some evidence that electroencephalography guidance of general anesthesia can decrease postoperative delirium after non-cardiac surgery.  There is limited evidence in this regard for cardiac surgery.  A suppressed electroencephalogram pattern, occurring with deep anesthesia, is associated with increased incidence of postoperative delirium (POD) and death.  However, it is not yet clear whether this electroencephalographic pattern reflects an underlying vulnerability associated with increased incidence of delirium and mortality, or whether it is a modifiable risk factor for these adverse outcomes.  Methods:   The  E lectroe  n cephalography  G uidance of  A nesthesia to Alleviate  Ge riatric  S yndromes (  ENGAGES-Canada ) is an ongoing pragmatic 1200 patient trial at four Canadian sites.  The study compares the effect of two anesthetic management approaches on the incidence of POD after cardiac surgery.  One approach is based on current standard anesthetic practice and the other on electroencephalography guidance to reduce POD. In the guided arm, clinicians are encouraged to decrease anesthetic administration, primarily if there is electroencephalogram suppression and secondarily if the EEG index is lower than the manufacturers recommended value (bispectral index (BIS) or WAVcns below 40 or Patient State Index below 25).  The aim in the guided group is to administer the minimum concentration of anesthetic considered safe for individual patients.  The primary outcome of the study is the incidence of POD, detected using the confusion assessment method or the confusion assessment method for the intensive care unit; coupled with structured delirium chart review.  Secondary outcomes include unexpected intraoperative movement, awareness, length of intensive care unit and hospital stay, delirium severity and duration, quality of life, falls, and predictors and outcomes of perioperative distress and dissociation.  Discussion:   The ENGAGES-Canada trial will help to clarify whether or not using the electroencephalogram to guide anesthetic administration during cardiac surgery decreases the incidence, severity, and duration of POD.  Registration:  ClinicalTrials.gov ( NCT02692300) 26/02/2016.",2019,"A suppressed electroencephalogram pattern, occurring with deep anesthesia, is associated with increased incidence of postoperative delirium (POD) and death.  ","['geriatric syndromes', '1200 patient trial at four Canadian sites']",[],"['unexpected intraoperative movement, awareness, length of intensive care unit and hospital stay, delirium severity and duration, quality of life, falls, and predictors and outcomes of perioperative distress and dissociation', 'incidence of POD, detected using the confusion assessment method or the confusion assessment method for the intensive care unit; coupled with structured delirium chart review', 'postoperative delirium', 'postoperative delirium (POD) and death']","[{'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]",[],"[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0034380'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0086168', 'cui_str': 'Dissociation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0009676', 'cui_str': 'Confusional State'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0541653', 'cui_str': 'Chart review'}, {'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.167213,"A suppressed electroencephalogram pattern, occurring with deep anesthesia, is associated with increased incidence of postoperative delirium (POD) and death.  ","[{'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Deschamps', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Montreal Heart Institute and Universite de Montreal, Montreal, Quebec, H1T 1C8, Canada.'}, {'ForeName': 'Tarit', 'Initials': 'T', 'LastName': 'Saha', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Queen's University, Kingston, Kingston, Ontario, Canada.""}, {'ForeName': 'Renée', 'Initials': 'R', 'LastName': 'El-Gabalawy', 'Affiliation': 'Department of Clinical Health Psychology, Anesthesiology, Perioperative and Pain Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Jacobsohn', 'Affiliation': 'Departments of Anesthesia and Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Overbeek', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Palermo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Robichaud', 'Affiliation': 'Montreal Heart Institute, Montreal, Quebec, H1T 1C8, Canada.'}, {'ForeName': 'Andrea Alicia', 'Initials': 'AA', 'LastName': 'Dumont', 'Affiliation': 'Montreal Health Innovation Coordinating Center, Montreal Heart Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Djaiani', 'Affiliation': 'Department of Anesthesia, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Carroll', 'Affiliation': 'Department of Anesthesia, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Morvarid S', 'Initials': 'MS', 'LastName': 'Kavosh', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Tanzola', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Queen's University, Kingston, Kingston, Ontario, Canada.""}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Schmitt', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachussetts, USA.'}, {'ForeName': 'Sharon K', 'Initials': 'SK', 'LastName': 'Inouye', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachussetts, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Oberhaus', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, St-Louis, Missouri, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Mickle', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, St-Louis, Missouri, USA.'}, {'ForeName': 'Arbi', 'Initials': 'A', 'LastName': 'Ben Abdallah', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, St-Louis, Missouri, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Avidan', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, St-Louis, Missouri, USA.'}, {'ForeName': 'Canadian Perioperative Anesthesia', 'Initials': 'CPA', 'LastName': 'Clinical Trials Group', 'Affiliation': 'Department of Anesthesia, University of Manitoba, Winnipeg, Manitoba, Canada.'}]",F1000Research,['10.12688/f1000research.19213.1']
1421,29775119,Effects of exercise in combination with autologous bone marrow stem cell transplantation for patients with type 1 diabetes.,"Stem cell therapy is a promising approach for the treatment of type 1 diabetes mellitus (T1D). Previous studies recommended regular exercise for the control of T1D. Experimental studies showed that a combination of stem cells and exercise yielded a better outcome. Yet, the effect of exercise programs following stem cell transplantation in patients with T1D has not been investigated. Thus, the current study aimed to examine the effect of a combined exercise program on measures of glycemic control in patients with T1D who received autologous bone marrow stem cell transplantation (ABMSCT). Thirty patients with controlled T1D were assigned into two equal groups. Both groups underwent ABMSCT and received insulin therapy and a diabetic diet regime. Only the exercise group followed the combined exercise program. Outcome measures of glycemic control (i.e. fasting blood glucose level [FBG], post-prandial blood glucose level [PPG], HbA1c, daily insulin dosage, and C-peptide levels) were tested before and after a 3-month rehabilitation period. There were significant ( p  < 0.05) decreases in all outcome measures except C-peptides after ABMSCT compared with before in both groups. Moreover, there was a significant decrease in the mean value of HbA1c in the exercise group compared with the control group after rehabilitation. Overall, this study strengthens the idea that adding exercise to ABMSCT is important to help control diabetes in patients with T1D.",2019,There were significant (p < 0.05) decreases in all outcome measures except C-peptides after ABMSCT compared with before in both groups.,"['type 1 diabetes mellitus (T1D', 'patients with T1D who received autologous bone marrow stem cell transplantation (ABMSCT', 'patients with type 1 diabetes', 'Thirty patients with controlled T1D', 'patients with T1D']","['Stem cell therapy', 'insulin therapy and a diabetic diet regime', 'autologous bone marrow stem cell transplantation', 'exercise', 'combined exercise program']","['glycemic control (i.e. fasting blood glucose level [FBG], post-prandial blood glucose level [PPG], HbA1c, daily insulin dosage, and C-peptide levels', 'mean value of HbA1c']","[{'cui': 'C0011854', 'cui_str': 'Diabetes Mellitus, Type 1'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0011878', 'cui_str': 'Diabetic Diet'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0428569', 'cui_str': 'Post-prandial blood glucose measurement'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",30.0,0.0233285,There were significant (p < 0.05) decreases in all outcome measures except C-peptides after ABMSCT compared with before in both groups.,"[{'ForeName': 'Marwa Taher', 'Initials': 'MT', 'LastName': 'Mohamed', 'Affiliation': 'Department of Basic Science, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Eman Ahmed', 'Initials': 'EA', 'LastName': 'Embaby', 'Affiliation': 'Department of Basic Science, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Awatif', 'Initials': 'A', 'LastName': 'Labib', 'Affiliation': 'Department of Basic Science, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'El-Husseiny', 'Affiliation': 'Department of Endocrinology, Wadi El-Neel Hospital, Cairo, Egypt.'}, {'ForeName': 'Hazem', 'Initials': 'H', 'LastName': 'Khamis', 'Affiliation': 'Department of Cardiology, 6th October University, Giza, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'El-Demery', 'Affiliation': 'Department of Medical Biocemistry, 6th October University, Elmehawar Almarkazy, Giza, Egypt.'}, {'ForeName': 'Mohamed Mounir', 'Initials': 'MM', 'LastName': 'Shoukry', 'Affiliation': 'Faculty of Pharmacy, MTI University, Cairo, Egypt.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1474511']
1422,31087216,"The Effects of Youth Anxiety Treatment on School Impairment: Differential Outcomes Across CBT, Sertraline, and their Combination.","Youth anxiety disorders are highly prevalent and are associated with considerable school impairment. Despite the identification of well-supported strategies for treating youth anxiety, research has yet to evaluate the differential effects of these treatments on anxiety-related school impairment. The present study leveraged data from the Child/Adolescent Anxiety Multimodal Study to examine differential treatment effects of CBT, sertraline, and their combination (COMB), relative to placebo (PBO), on anxiety-related school impairment among youth (N = 488). Latent growth modeling revealed that all three active treatments demonstrated superiority over PBO in reducing anxiety-related school impairment over time, with COMB showing the most robust effects. According to parent report, medication strategies may have stronger effects on anxiety-related school impairment among males than among females. Results were discrepant across parents and youth. Findings are discussed in terms of clinical implications for anxious youth and the need for continued research to examine treatment effects on anxiety-related school impairment.",2019,"Latent growth modeling revealed that all three active treatments demonstrated superiority over PBO in reducing anxiety-related school impairment over time, with COMB showing the most robust effects.","['anxiety-related school impairment among youth (N\u2009=\u2009488', 'males than among females', 'School Impairment', 'Youth anxiety disorders']","['Youth Anxiety Treatment', 'CBT, sertraline, and their combination (COMB), relative to placebo (PBO']",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}]","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}]",[],,0.0194692,"Latent growth modeling revealed that all three active treatments demonstrated superiority over PBO in reducing anxiety-related school impairment over time, with COMB showing the most robust effects.","[{'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Sanchez', 'Affiliation': 'Center for Children and Families and Department of Psychology, Florida International University, Miami, FL, USA. amasanch@fiu.edu.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Comer', 'Affiliation': 'Center for Children and Families and Department of Psychology, Florida International University, Miami, FL, USA.'}, {'ForeName': 'Stefany', 'Initials': 'S', 'LastName': 'Coxe', 'Affiliation': 'Center for Children and Families and Department of Psychology, Florida International University, Miami, FL, USA.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Albano', 'Affiliation': 'Division of Child & Adolescent Psychiatry, Department of Psychiatry, Columbia University Medical Center, New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Piacentini', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, CA, USA.'}, {'ForeName': 'Scott N', 'Initials': 'SN', 'LastName': 'Compton', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Duke University, Durham, NC, USA.'}, {'ForeName': 'Golda S', 'Initials': 'GS', 'LastName': 'Ginsburg', 'Affiliation': 'Department of Psychiatry, University of Connecticut School of Medicine, Farmington, CT, USA.'}, {'ForeName': 'Moira A', 'Initials': 'MA', 'LastName': 'Rynn', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Duke University, Durham, NC, USA.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Walkup', 'Affiliation': ""Anne and Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.""}, {'ForeName': 'Dara J', 'Initials': 'DJ', 'LastName': 'Sakolsky', 'Affiliation': 'Western Psychiatric Institute and Clinic-University of Pittsburgh Medical Center, Pittsburgh, USA.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Birmaher', 'Affiliation': 'Western Psychiatric Institute and Clinic-University of Pittsburgh Medical Center, Pittsburgh, USA.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Kendall', 'Affiliation': 'Department of Psychology, Temple University, Philadelphia, PA, USA.'}]",Child psychiatry and human development,['10.1007/s10578-019-00896-3']
1423,31538590,Docosahexaenoic Acid and Arachidonic Acid Supplementation and Sleep in Toddlers Born Preterm: Secondary Analysis of a Randomized Clinical Trial.,"STUDY OBJECTIVES


This secondary analysis characterized sleep patterns for toddlers born preterm and tested effects of docosahexaenoic acid (DHA)+ arachidonic acid (AA) supplementation on children's caregiver-reported sleep. Exploratory analyses tested whether child sex, birth weight, and caregiver depressive symptomatology were moderators of the treatment effect.
METHODS


Omega Tots was a single-site 180-day randomized (1:1), double-blinded, placebo-controlled trial. Children (n = 377) were age 10 to 16 months at enrollment, born at less than 35 weeks' gestation, assigned to 180 days of daily 200 mg DHA + 200 mg AA supplementation or placebo (400 mg corn oil), and followed after the trial ended to age 26 to 32 months. Caregivers completed a sociodemographic profile and questionnaires about their depressive symptomatology (Center for Epidemiologic Studies Depression Scale) and the child's sleep (Brief Infant Sleep Questionnaire). Analyses compared changes in sleep between the DHA+AA and placebo groups, controlling for baseline scores. Exploratory post hoc subgroup analyses were conducted.
RESULTS


Eighty-one percent (n tx  = 156; n placebo  = 150) of children had 180-day trial outcome data; 68% (n tx  = 134; n placebo  = 122) had postintervention outcome data. Differences in change between the DHA+AA and placebo groups after 180 days of supplementation were not statistically significant for the entire cohort. Male children (difference in nocturnal sleep change = 0.44, effect size = 0.26, P = .04; sleep problems odds ratio = 0.36, 95% confidence interval = 0.15, 0.82) and children of depressed caregivers (difference in nocturnal sleep change = 1.07, effect size = 0.65, P = .006; difference in total sleep change = 1.10, effect size = 0.50, P = .04) assigned to the treatment group showed improvements in sleep, compared to placebo.
CONCLUSIONS


Although there is no evidence of an overall effect of DHA+AA supplementation on child sleep, exploratory post hoc analyses identified important subgroups of children born preterm who may benefit. Future research including larger samples is warranted.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Identifier: NCT01576783.
CITATION


Boone KM, Rausch J, Pelak G, Li R, Turner AN, Klebanoff MA, Keim SA. Docosahexaenoic acid and arachidonic acid supplementation and sleep in toddlers born preterm: secondary analysis of a randomized clinical trial. J Clin Sleep Med. 2019;15(9):1197-1208.",2019,"Male children (difference in nocturnal sleep change = 0.44, effect size = 0.26, P","['Male children', 'toddlers born preterm', 'Toddlers Born Preterm', ""Children (n = 377) were age 10 to 16 months at enrollment, born at less than 35 weeks' gestation"", ""children's caregiver-reported sleep"", 'Eighty-one percent (n tx  = 156; n']","['DHA+AA supplementation', 'docosahexaenoic acid (DHA)+ arachidonic acid (AA) supplementation', 'Docosahexaenoic Acid and Arachidonic Acid Supplementation and Sleep', 'placebo', 'DHA + 200 mg AA supplementation or placebo', 'Docosahexaenoic acid and arachidonic acid supplementation']","['total sleep change', ""sociodemographic profile and questionnaires about their depressive symptomatology (Center for Epidemiologic Studies Depression Scale) and the child's sleep (Brief Infant Sleep Questionnaire"", 'child sex, birth weight, and caregiver depressive symptomatology']","[{'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}]","[{'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0556098', 'cui_str': 'Arachidonic acid supplementation (product)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]",,0.812072,"Male children (difference in nocturnal sleep change = 0.44, effect size = 0.26, P","[{'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Boone', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rausch', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Pelak', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Abigail Norris', 'Initials': 'AN', 'LastName': 'Turner', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, College of Medicine, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Klebanoff', 'Affiliation': 'Department of Pediatrics, College of Medicine, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Keim', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7902']
1424,31538598,Eye-Blink Parameters Detect On-Road Track-Driving Impairment Following Severe Sleep Deprivation.,"STUDY OBJECTIVES


Drowsiness leads to 20% of fatal road crashes, while inability to assess drowsiness has hampered drowsiness interventions. This study examined the accuracy of eye-blink parameters for detecting drowsiness related driving impairment in real time.
METHODS


Twelve participants undertook two sessions of 2-hour track-driving in an instrumented vehicle following a normal night's sleep or 32 to 34 hours of extended wake in a randomized crossover design. Eye-blink parameters and lane excursion events were monitored continuously.
RESULTS


Sleep deprivation increased the rates of out-of-lane driving events and early drive terminations. Episodes of prolonged eyelid closures, blink duration, the ratio of amplitude to velocity of eyelid closure, and John's Drowsiness Score (JDS, a composite score) were also increased following sleep deprivation. A time-on-task (drive duration) effect was evident for out-of-lane events rate and most eye-blink parameters after sleep deprivation. The JDS demonstrated the strongest association with the odds of out-of-lane events in the same minute, whereas measures of blink duration and prolonged eye closure were stronger indicators of risk for out-of-lane events over longer periods of 5 minutes and 15 minutes, respectively. Eye-blink parameters also achieved moderate accuracies (specificities from 70.12% to 84.15% at a sensitivity of 50%) for detecting out-of-lane events in the same minute, with stronger associations over longer timeframes of 5 minutes to 15 minutes.
CONCLUSIONS


Eyelid closure parameters are useful tools for monitoring and predicting drowsiness-related driving impairment (out-of-lane events) that could be utilized for monitoring drowsiness and assessing the efficacy of drowsiness interventions.
CLINICAL TRIAL REGISTRATION


This study is registered with the Australian New Zealand Clinical Trial Registry (ANCTR), http://www.anzctr.org.au/TrialSearch.aspx ACTRN12612000102875.
CITATION


Shekari Soleimanloo S, Wilkinson VE, Cori JM,Westlake J, Stevens B, Downey LA, Shiferaw BA, Rajaratnam SMW, Howard ME. Eye-blink parameters detect on-road track-driving impairment following severe sleep deprivation. J Clin Sleep Med. 2019;15(9):1271-1284.",2019,"Eye-blink parameters also achieved moderate accuracies (specificities from 70.12% to 84.15% at a sensitivity of 50%) for detecting out-of-lane events in the same minute, with stronger associations over longer timeframes of 5 minutes to 15 minutes.
",['severe sleep deprivation'],"[""2-hour track-driving in an instrumented vehicle following a normal night's sleep""]","['rates of out-of-lane driving events and early drive terminations', 'blink duration and prolonged eye closure', 'A time-on-task (drive duration) effect', 'Eye-blink parameters and lane excursion events', 'Eye-Blink Parameters Detect', ""Episodes of prolonged eyelid closures, blink duration, the ratio of amplitude to velocity of eyelid closure, and John's Drowsiness Score (JDS, a composite score""]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}]","[{'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0005757', 'cui_str': 'Blinking'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C1269837', 'cui_str': 'Surgical closure of eye structure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1293738', 'cui_str': 'Eyelid closure'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0013144', 'cui_str': 'Drowsy (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",12.0,0.019793,"Eye-blink parameters also achieved moderate accuracies (specificities from 70.12% to 84.15% at a sensitivity of 50%) for detecting out-of-lane events in the same minute, with stronger associations over longer timeframes of 5 minutes to 15 minutes.
","[{'ForeName': 'Shamsi', 'Initials': 'S', 'LastName': 'Shekari Soleimanloo', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Vanessa E', 'Initials': 'VE', 'LastName': 'Wilkinson', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Cori', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Westlake', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Stevens', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Luke A', 'Initials': 'LA', 'LastName': 'Downey', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Brook A', 'Initials': 'BA', 'LastName': 'Shiferaw', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Shantha M W', 'Initials': 'SMW', 'LastName': 'Rajaratnam', 'Affiliation': 'School of Psychological Sciences, Monash University, Australia.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Howard', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7918']
1425,31506292,Effects of Selonsertib in Patients with Diabetic Kidney Disease.,"BACKGROUND


Apoptosis signal-regulating kinase 1 (ASK1) activation in glomerular and tubular cells resulting from oxidative stress may drive kidney disease progression. Findings in animal models identified selonsertib, a selective ASK1 inhibitor, as a potential therapeutic agent.
METHODS


In a phase 2 trial evaluating selonsertib's safety and efficacy in adults with type 2 diabetes and treatment-refractory moderate-to-advanced diabetic kidney disease, we randomly assigned 333 adults in a 1:1:1:1 allocation to selonsertib (oral daily doses of 2, 6, or 18 mg) or placebo. Primary outcome was change from baseline eGFR at 48 weeks.
RESULTS


Selonsertib appeared safe, with no dose-dependent adverse effects over 48 weeks. Although mean eGFR for selonsertib and placebo groups did not differ significantly at 48 weeks, acute effects related to inhibition of creatinine secretion by selonsertib confounded eGFR differences at 48 weeks. Because of this unanticipated effect, we used piecewise linear regression, finding two dose-dependent effects: an acute and more pronounced eGFR decline from 0 to 4 weeks (creatinine secretion effect) and an attenuated eGFR decline between 4 and 48 weeks (therapeutic effect) with higher doses of selonsertib. A post hoc analysis (excluding data for 20 patients from two sites with Good Clinical Practice compliance-related issues) found that between 4 and 48 weeks, rate of eGFR decline was reduced 71% for the 18-mg group relative to placebo (difference 3.11±1.53 ml/min per 1.73 m 2  annualized over 1 year; 95% confidence interval, 0.10-6.13; nominal  P =0.043). Effects on urine albumin-to-creatinine ratio did not differ between selonsertib and placebo.
CONCLUSIONS


Although the trial did not meet its primary endpoint, exploratory post hoc analyses suggest that selonsertib may slow diabetic kidney disease progression.",2019,"Effects on urine albumin-to-creatinine ratio did not differ between selonsertib and placebo.
","['Patients with Diabetic Kidney Disease', 'adults with type 2 diabetes and treatment-refractory moderate-to-advanced diabetic kidney disease']","['Selonsertib', 'placebo']","['urine albumin-to-creatinine ratio', 'mean eGFR', 'eGFR decline', 'rate of eGFR decline', 'adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0042037'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",333.0,0.58165,"Effects on urine albumin-to-creatinine ratio did not differ between selonsertib and placebo.
","[{'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Division of Nephrology, Department of Medicine, Stanford University School of Medicine, Stanford, California; gchertow@stanford.edu.'}, {'ForeName': 'Pablo E', 'Initials': 'PE', 'LastName': 'Pergola', 'Affiliation': 'Renal Associates PA, San Antonio, Texas; and.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Kirby', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Sundy', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California.'}, {'ForeName': 'Uptal D', 'Initials': 'UD', 'LastName': 'Patel', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2018121231']
1426,31538599,Can the Orexin Antagonist Suvorexant Preserve the Ability to Awaken to Auditory Stimuli While Improving Sleep?,"STUDY OBJECTIVES


The safety profile of the dual orexin receptor antagonists (DORAs) are currently unknown with regard to nocturnal responsivity among people with insomnia. We compared the auditory awakening thresholds (AATs) of the DORA suvorexant (10 and 20 mg) versus placebo in 12 individuals with DSM-5 insomnia.
METHODS


The study used a double-blind, placebo-controlled, three-way crossover design. Participants were randomly assigned to a treatment sequence that included placebo, suvorexant 10 mg, and suvorexant 20 mg. At the time of maximum drug concentration, auditory tones were played during stable stage N2 sleep. Tones increased by 5-decibel (db) increments until the participant awakened. The db at awakening was recorded as the AAT and compared between conditions. The proportion of awakenings higher than 85 db was also compared between conditions. Finally, sensitivity analyses were also conducted using surrounding thresholds (80 db and 90 db).
RESULTS


The mean AAT did not differ significantly between either dose of suvorexant compared to placebo. Moreover, the proportions of individuals who remained asleep at the AAT 85 db cutoff did not differ across conditions. In addition, wake after sleep onset decreased and total sleep time increased in the suvorexant 20 mg condition compared to placebo.
CONCLUSIONS


Suvorexant (10 and 20 mg) preserved the ability to respond to nocturnal stimuli, whereas the 20-mg dose improved the sleep of people with insomnia. This suggests that DORAs such as suvorexant can effectively treat insomnia while allowing patients to awaken to nocturnal stimuli in the environment.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Title: A Phase IV 3-Way Double-blind, Randomized, Crossover Study to Compare the Awakening Threshold Effects (Responsivity) of Belsomra 10 mg and 20 mg to Placebo in Non-elderly Insomniacs; Identifier NCT03312517; URL: https://clinicaltrials.gov/ct2/show/NCT03312517.
CITATION


Drake CL, Kalmbach DA, Cheng P, Roth T, Tran KM, Cuamatzi-Castelan A, Atkinson R, SinghM, Tonnu CV, Fellman-Couture C. Can the orexin antagonist suvorexant preserve the ability to awaken to auditory stimuli while improving sleep? J Clin Sleep Med. 2019;15(9):1285-1291.",2019,The mean AAT did not differ significantly between either dose of suvorexant compared to placebo.,"['people with insomnia', '12 individuals with DSM-5 insomnia', 'Non-elderly Insomniacs']","['auditory awakening thresholds (AATs) of the DORA suvorexant', 'Belsomra 10 mg and 20 mg to Placebo', 'placebo, suvorexant 10 mg, and suvorexant 20 mg', 'placebo', 'dual orexin receptor antagonists (DORAs']","['total sleep time', 'mean AAT', 'sleep of people with insomnia', 'proportion of awakenings higher', 'Ability to Awaken to Auditory Stimuli']","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C3179535', 'cui_str': 'suvorexant'}, {'cui': 'C3854974', 'cui_str': 'Belsomra'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3854969', 'cui_str': 'suvorexant 10 MG'}, {'cui': 'C3854984', 'cui_str': 'suvorexant 20 MG'}, {'cui': 'C4046055', 'cui_str': 'Dual Orexin Receptor Antagonists'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus, function (observable entity)'}]",,0.0638037,The mean AAT did not differ significantly between either dose of suvorexant compared to placebo.,"[{'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roth', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Kieulinh Michelle', 'Initials': 'KM', 'LastName': 'Tran', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cuamatzi-Castelan', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Atkinson', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Meeta', 'Initials': 'M', 'LastName': 'Singh', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Christine V', 'Initials': 'CV', 'LastName': 'Tonnu', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Fellman-Couture', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7920']
1427,31538602,CPAP and Health-Related Quality of Life in Adults With Coronary Artery Disease and Nonsleepy Obstructive Sleep Apnea in the RICCADSA Trial.,"STUDY OBJECTIVES


To determine the effect of continuous positive airway pressure (CPAP) treatment on health-related quality of life (HRQoL) in adults with coronary artery disease (CAD) and nonsleepy obstructive sleep apnea (OSA).
METHODS


This was a secondary outcome analysis of the RICCADSA trial, conducted in Sweden between 2005 and 2013. Adults with CAD, nonsleepy OSA (apnea-hypopnea index [AHI] ≥ 15 events/h; Epworth Sleepiness Scale [ESS] score < 10) and complete Short-Form (SF)-36 questionnaires at baseline and after 12 months were included. Patients were randomized to CPAP (n = 102) or no CPAP (n = 104). The primary outcome was the between-group difference in absolute change in the SF-36 components. Within-group changes as well as variables associated with absolute change in the domains in the entire population were also tested.
RESULTS


Mean SF-36 scores were similar at baseline, ranging from 44.9 ± 9.6 to 92.2 ± 15.8 in various domains, and between-group changes from baseline were not statistically significant at 1 year. There was a significant increase in Role physical, Vitality, Role emotional, Mental health and Mental Component Summary (MCS), and a decrease in Bodily pain and General health scores in the CPAP group. The change in Physical Component Summary (PCS) was determined by female sex (beta coefficient -0.19, 95% confidence interval [CI] -7.25 to -0.98, P = .010), baseline AHI (beta coefficient -0.19, 95% CI -0.21 to -0.03, P = .009), CPAP use (h/night) (beta coefficient -0.16, 95% CI -0.93 to -0.06, P = .028), and acute myocardial infarction at baseline (beta coefficient 0.18, 95% CI 0.59 to 5.19, P = .014). Determinants of the change in MCS from baseline were change in the ESS score (beta coefficient -0.14, 95% CI -0.87 to -0.01, P = .054) and change in the Zung Self-rated Depression Scale scores (beta coefficient -0.33, 95% CI -0.58 to -0.24, P < .001).
CONCLUSIONS


Assignment to CPAP treatment compared to no CPAP had no significant effect on HRQoL as measured by the SF-36 in adults with CAD and nonsleepy OSA. Although several components of the SF-36 scores were improved within the CPAP group, CPAP use was associated with a decrease in PCS. The improvement in MCS was determined by the improvement in daytime sleepiness and depressive mood.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Identifier: NCT00519597.
CITATION


Wallström S, Balcan B, Thunström E, Wolf A, Peker Y. CPAP and health-related quality of life in adults with coronary artery disease and nonsleepy obstructive sleep apnea in the RICCADSA trial. J Clin Sleep Med. 2019;15(9):1311-1320.",2019,"There was a significant increase in Role physical, Vitality, Role emotional, Mental health and Mental Component Summary (MCS), and a decrease in Bodily pain and General health scores in the CPAP group.","['Adults with CAD, nonsleepy OSA (apnea-hypopnea index [AHI', 'adults with coronary artery disease and nonsleepy obstructive sleep apnea in the RICCADSA trial', 'Adults With Coronary Artery Disease and Nonsleepy Obstructive Sleep Apnea in the RICCADSA Trial', 'adults with CAD and nonsleepy OSA', 'adults with coronary artery disease (CAD) and nonsleepy obstructive sleep apnea (OSA']","['no CPAP', 'continuous positive airway pressure (CPAP', 'CPAP']","['CPAP and Health-Related Quality of Life', 'beta coefficient', 'MCS', 'baseline AHI (beta coefficient', 'HRQoL', 'ESS score', 'Zung Self-rated Depression Scale scores', 'Mean SF-36 scores', 'SF-36 scores', 'health-related quality of life (HRQoL', 'CPAP use (h/night) ', ' Epworth Sleepiness Scale [ESS] score < 10) and complete Short-Form (SF)-36 questionnaires', 'Role physical, Vitality, Role emotional, Mental health and Mental Component Summary (MCS', 'PCS', 'change in Physical Component Summary (PCS', 'Bodily pain and General health scores', 'acute myocardial infarction', 'daytime sleepiness and depressive mood', 'absolute change in the SF-36 components']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4273947', 'cui_str': 'Zung self rating depression scale score (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C4706348', 'cui_str': 'Epworth Sleepiness Scale score (observable entity)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}]",,0.224914,"There was a significant increase in Role physical, Vitality, Role emotional, Mental health and Mental Component Summary (MCS), and a decrease in Bodily pain and General health scores in the CPAP group.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wallström', 'Affiliation': 'Institute of Health and Care Sciences, University of Gothenburg, Sweden.'}, {'ForeName': 'Baran', 'Initials': 'B', 'LastName': 'Balcan', 'Affiliation': 'Department of Pulmonary Medicine, Marmara University, School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Thunström', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institution of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Institute of Health and Care Sciences, University of Gothenburg, Sweden.'}, {'ForeName': 'Yüksel', 'Initials': 'Y', 'LastName': 'Peker', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institution of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7926']
1428,29730131,Relationship between mother-infant mutual dyadic responsiveness and premature infant development as measured by the Bayley III at 6 weeks corrected age.,"BACKGROUND


The quality of mother-preterm infant interaction has been identified as a key factor in influencing the infant's later development and language acquisition. The relationship between mother-infant responsiveness and later development may be evident early in infancy, a time period which has been understudied.
AIM


Describe the relationship between mother-infant mutual dyadic responsiveness and premature infant development.
DESIGN


This study employed a secondary analysis of data from the 6-week corrected age (CA) follow-up visit of the Hospital-Home Transition: Optimizing Prematures' Environment (H-HOPE) study, a randomized clinical trial testing the efficacy of a mother- and infant- focused intervention for improving outcomes among premature infants.
SUBJECTS


Premature infants born between 29 and 34 weeks gestational age and their mothers who had social-environmental risks.
OUTCOME MEASURES


At 6-weeks corrected age, a play session was coded for the quality of mutual responsiveness (Dyadic Mutuality Code). Development was assessed via the Bayley Scales of Infant and Toddler Development, 3rd edition.
RESULTS


Of 137 mother-infant dyads, high, medium and low mutual responsiveness was observed for 35.8%, 34.3% and 29.9%, respectively. Overall motor, language and cognitive scores were 115.8 (SD = 8.2), 108.0 (7.7) and 109.3 (7.9). Multivariable linear models showed infants in dyads with high versus low mutual responsiveness had higher scores on the motor (β = 3.07, p = 0.06) and language (β = 4.47, p = 0.006) scales.
CONCLUSION


High mutual responsiveness in mother-premature infant dyads is associated with significantly better language development and marginally better motor development.",2018,"Multivariable linear models showed infants in dyads with high versus low mutual responsiveness had higher scores on the motor (β = 3.07, p = 0.06) and language (β = 4.47, p = 0.006) scales.
CONCLUSION


High mutual responsiveness in mother-premature infant dyads is associated with significantly better language development and marginally better motor development.","['Premature infants born between 29 and 34\u202fweeks gestational age and their mothers who had social-environmental risks', 'premature infants']",['mother- and infant- focused intervention'],"['Overall motor, language and cognitive scores']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0411692,"Multivariable linear models showed infants in dyads with high versus low mutual responsiveness had higher scores on the motor (β = 3.07, p = 0.06) and language (β = 4.47, p = 0.006) scales.
CONCLUSION


High mutual responsiveness in mother-premature infant dyads is associated with significantly better language development and marginally better motor development.","[{'ForeName': 'Rosemary C', 'Initials': 'RC', 'LastName': 'White-Traut', 'Affiliation': ""Department of Women, Children, and Family Health Science, University of Illinois at Chicago, College of Nursing, 845 South Damen Avenue, Chicago, IL 60612, United States; Children's Hospital of Wisconsin, Children's Corporate Center, P. O. Box 1997, MSC 140, Milwaukee, WI 53201-1997, United States. Electronic address: rwt@uic.edu.""}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Rankin', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health, University of Illinois at Chicago, 1603 West Taylor Street, Chicago, IL 60612, United States.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Yoder', 'Affiliation': 'Department of Women, Children, and Family Health Science, University of Illinois at Chicago, College of Nursing, 845 South Damen Avenue, Chicago, IL 60612, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Zawacki', 'Affiliation': 'Department of Physical and Occupational Therapy, University of Illinois Hospital and Health Sciences System, 1600 West Taylor Street, Chicago, IL 60612, United States.'}, {'ForeName': 'Suzann', 'Initials': 'S', 'LastName': 'Campbell', 'Affiliation': 'Department of Physical Therapy, College of Applied Health Sciences, University of Illinois at Chicago, 1919 West Taylor Street, Chicago, IL 60612, United States.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kavanaugh', 'Affiliation': ""Children's Hospital of Wisconsin, Children's Corporate Center, P. O. Box 1997, MSC 140, Milwaukee, WI 53201-1997, United States.""}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Brandon', 'Affiliation': 'Duke University School of Nursing, DUMC 3322, 307 Trent Drive, Durham, NC 27710, United States.'}, {'ForeName': 'Kathleen F', 'Initials': 'KF', 'LastName': 'Norr', 'Affiliation': 'Department of Women, Children, and Family Health Science, University of Illinois at Chicago, College of Nursing, 845 South Damen Avenue, Chicago, IL 60612, United States.'}]",Early human development,['10.1016/j.earlhumdev.2018.04.018']
1429,32411045,Mindfulness Training for Improving Attention Regulation in University Students: Is It Effective? and Do Yoga and Homework Matter?,"The present study examined the effects of mindfulness training on attention regulation in university students and whether the potential benefits of implementation are influenced by the yoga component of mindfulness-based interventions (MBIs) and/or by MBI homework practice. In a non-randomized trial with pre- and post-assessments,  n  = 180 university students were allocated to either mindfulness training (experimental groups), awareness activities (active control group), or no training (passive control group). Mindfulness was taught through two MBIs, one including yoga and the other excluding yoga. Attention regulation was operationalized via behavioral indicators, namely sustained attention, cognitive flexibility, cognitive inhibition, and data-driven information processing. With the exception of speed in a cognitive flexibility task, the results indicated no systematic or differential advantage arising from mindfulness training, with or without yoga, regarding the aspects of attention regulation. There was no consistent influence of homework quantity or quality. The implications for mindfulness training in academic contexts are discussed.",2020,"With the exception of speed in a cognitive flexibility task, the results indicated no systematic or differential advantage arising from mindfulness training, with or without yoga, regarding the aspects of attention regulation.","['University Students', 'university students', 'n  = 180 university students']","['Mindfulness Training', 'mindfulness training (experimental groups), awareness activities (active control group), or no training (passive control group', 'mindfulness training']",['homework quantity or quality'],"[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0589414', 'cui_str': 'Homework'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.0113017,"With the exception of speed in a cognitive flexibility task, the results indicated no systematic or differential advantage arising from mindfulness training, with or without yoga, regarding the aspects of attention regulation.","[{'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Wimmer', 'Affiliation': 'Department of Psychology, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Silja', 'Initials': 'S', 'LastName': 'Bellingrath', 'Affiliation': 'Department of Psychology, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'von Stockhausen', 'Affiliation': 'Department of Psychology, University of Duisburg-Essen, Essen, Germany.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00719']
1430,31560027,Lower-Extremity Torque Capacity and Physical Function in Mobility-Limited Older Adults.,"OBJECTIVES


Skeletal muscle weakness and an increase in fatigability independently contribute to age-related functional decline. The objective of this study was to examine the combined contribution of these deficiencies (i.e., torque capacity) to physical function, and then to assess the functional implications of progressive resistance training (PRT) mediated-torque capacity improvements in mobility-limited older adults.
DESIGN


Randomized controlled trial.
SETTING


Exercise laboratory on the Health Sciences campus of an urban university.
PARTICIPANTS


Seventy mobility-limited (Short Physical Performance Battery (SPPB) ≤9) older adults (~79 yrs).
INTERVENTION


Progressive resistance training or home-based flexibility 3 days/week for 12 weeks.
MEASUREMENTS


Torque capacity was defined as the sum of peak torques from an isokinetic knee extension fatigue test. Relationships between torque capacity and performance-based and patient-reported functional measures before and after PRT were examined using partial correlations adjusted for age, sex, and body mass index.
RESULTS


Torque capacity explained (P<0.05) 10 and 28% of the variance in six-minute walk distance and stair climb time, respectively. PRT-mediated torque capacity improvements were paralleled by increases (P<0.05) in self-reported activity participation (+20%) and advanced lower extremity function (+7%), and associated (P<0.05) with a reduction in activity limitations (r=0.44) and an improved SPPB score (r=0.32).
CONCLUSION


Skeletal muscle torque capacity, a composite of strength and fatigue, may be a proximal determinant of physical function in mobility-limited older individuals. To more closely replicate the musculoskeletal demands of real-life tasks, future studies are encouraged to consider the combined interaction of distinct skeletal muscle faculties to overall functional ability in older adults.",2019,"RESULTS


Torque capacity explained (P<0.05) 10 and 28% of the variance in six-minute walk distance and stair climb time, respectively.","['Seventy mobility-limited (Short Physical Performance Battery (SPPB) ≤9) older adults (~79 yrs', 'older adults', 'Exercise laboratory on the Health Sciences campus of an urban university', 'mobility-limited older adults', 'Mobility-Limited Older Adults']","['Progressive resistance training or home-based flexibility 3 days/week for 12 weeks', 'progressive resistance training (PRT']","['activity participation', 'Torque capacity', 'PRT-mediated torque capacity improvements', 'activity limitations', 'advanced lower extremity function', 'SPPB score', 'Lower-Extremity Torque Capacity and Physical Function', 'peak torques from an isokinetic knee extension fatigue test']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",70.0,0.0312026,"RESULTS


Torque capacity explained (P<0.05) 10 and 28% of the variance in six-minute walk distance and stair climb time, respectively.","[{'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Grosicki', 'Affiliation': 'Gregory J. Grosicki, Ph.D., Department of Health Sciences and Kinesiology, Biodynamics and Human Performance Center, Georgia Southern University (Armstrong Campus), 11935 Abercorn Street, Savannah, GA, 31419. Phone: (912) 344-3317. Fax: (912) 344-3490. Email: ggrosicki@georgiasouthern.edu.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Englund', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Price', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Iwai', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kashiwa', 'Affiliation': ''}, {'ForeName': 'K F', 'Initials': 'KF', 'LastName': 'Reid', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Fielding', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-019-1232-8']
1431,32411039,The Effect of an Enriched Sport Program on Children's Executive Functions: The ESA Program.,"Purpose


The effects of physical exercise on executive functions (EFs) are well-documented. EFs are involved in daily activities, and their development determines the quality of people's future life, both in terms of mental health and quality of life. The purpose of the current paper is to evaluate the effects of a physical education program, elaborated within the Enriched Sports Activity Program (ESA Program), an Erasmus + Project, on EFs, namely, visuospatial working memory, inhibitory control, cognitive flexibility, and task switching.
Method


Data were collected on November 2017 (t 1 ) and May 2018 (t 2 ). At t 1 , a sample of 357 children from four European countries (Italy, Germany, Lithuania, and Turkey) performed a cognitive test battery made up of Digit Span Forward/Backward, Stroop Task, and Trail Making Test (TMT), whose order was randomized. From November until May, classrooms from the experimental group followed the ESA Program, while classrooms from the control continued with the ordinary physical education class. At t 2 , children from both experimental and control groups performed again the cognitive battery.
Result


The repeated measures ANOVA showed a significant effect of the ESA Program on the TMT B and on Digit Span Backward, but no significant effects were found on Digit Span Forward and Stroop Task.
Conclusion


The introduction of a sport program enriched with cognitive stimuli has beneficial effects for children working memory and cognitive flexibility.",2020,"The repeated measures ANOVA showed a significant effect of the ESA Program on the TMT B and on Digit Span Backward, but no significant effects were found on Digit Span Forward and Stroop Task.
","[""Children's Executive Functions"", '357 children from four European countries (Italy, Germany, Lithuania, and Turkey) performed a']","['physical exercise', 'cognitive test battery made up of Digit Span Forward/Backward, Stroop Task, and Trail Making Test (TMT', 'Enriched Sport Program', 'sport program enriched with cognitive stimuli', 'physical education program, elaborated within the Enriched Sports Activity Program (ESA Program']","['executive functions (EFs', 'Digit Span Forward and Stroop Task', 'TMT B and on Digit Span Backward']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0023879', 'cui_str': 'Lithuania'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439781', 'cui_str': 'Backward'}]",357.0,0.0123656,"The repeated measures ANOVA showed a significant effect of the ESA Program on the TMT B and on Digit Span Backward, but no significant effects were found on Digit Span Forward and Stroop Task.
","[{'ForeName': 'Ambra', 'Initials': 'A', 'LastName': 'Gentile', 'Affiliation': 'Ph.D. Program in Health Promotion and Cognitive Sciences, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Boca', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Fatma Neşe', 'Initials': 'FN', 'LastName': 'Şahin', 'Affiliation': 'Faculty of Sports Science, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Özkan', 'Initials': 'Ö', 'LastName': 'Güler', 'Affiliation': 'Faculty of Sports Science, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Pajaujiene', 'Affiliation': 'Department of Coaching Science, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Vinga', 'Initials': 'V', 'LastName': 'Indriuniene', 'Affiliation': 'Department of Physical and Social Education, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Demetriou', 'Affiliation': 'Department of Sport and Health Sciences, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sturm', 'Affiliation': 'Department of Sport and Health Sciences, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Gómez-López', 'Affiliation': 'Department of Physical Activity and Sport, Faculty of Sports Sciences, University of Murcia, Murcia, Spain.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Bianco', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Alesi', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Palermo, Italy.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00657']
1432,31852811,"Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil, and Leucovorin Versus Oxaliplatin, 5-Fluorouracil, Leucovorin, and Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Preoperative Chemoradiation: A Trial of the ECOG-ACRIN Research Group (E5204).","BACKGROUND


The addition of bevacizumab to chemotherapy improved outcomes for patients with metastatic colon cancer. E5204 was designed to test whether the addition of bevacizumab to mFOLFOX6, following neoadjuvant chemoradiation and definitive surgery, could improve overall survival (OS) in patients with stage II/III adenocarcinoma of the rectum.
SUBJECTS, MATERIALS, AND METHODS


Patients with stage II/III rectal cancer who had completed neoadjuvant 5-fluorouracil-based chemoradiation and had undergone complete resection were enrolled. Patients were randomized to mFOLFOX6 (Arm A) or mFOLFOX6 with bevacizumab (Arm B) administered every 2 weeks for 12 cycles.
RESULTS


E5204 registered only 355 patients (17% of planned accrual goal) as it was terminated prematurely owing to poor accrual. At a median follow-up of 72 months, there was no difference in 5-year overall survival (88.3% vs. 83.7%) or 5-year disease-free survival (71.2% vs. 76.5%) between the two arms. The rate of treatment-related grade ≥ 3 adverse events (AEs) was 68.8% on Arm A and 70.7% on Arm B. Arm B had a higher proportion of patients who discontinued therapy early as a result of AEs and patient withdrawal than did Arm A (32.4% vs. 21.5%, p = .029).The most common grade 3-4 treatment-related AEs were neutropenia, leukopenia, neuropathy, diarrhea (without prior colostomy), and fatigue.
CONCLUSION


At 17% of its planned accrual, E5204 did not meet its primary endpoint. The addition of bevacizumab to FOLFOX6 in the adjuvant setting did not significantly improve OS in patients with stage II/III rectal cancer.
IMPLICATIONS FOR PRACTICE


At 17% of its planned accrual, E5204 was terminated early owing to poor accrual. At a median follow-up of 72 months, there was no significant difference in 5-year overall survival (88.3% vs. 83.7%) or in 5-year disease-free survival (71.2% vs. 76.5%) between the two arms. Despite significant advances in the treatment of rectal cancer, especially in improving local control rates, the risk of distant metastases and the need to further improve quality of life remain a challenge. Strategies combining novel agents with chemoradiation to improve both distant and local control are needed.",2020,"The rate of treatment-related grade ≥ 3 adverse events (AEs) was 68.8% on Arm A and 70.7% on Arm B. Arm B had a higher proportion of patients who discontinued therapy early as a result of AEs and patient withdrawal than did Arm A (32.4% vs. 21.5%,  ","['patients with stage II/III rectal cancer', 'patients with stage II/III adenocarcinoma of the rectum', 'patients with metastatic colon cancer', 'Patients with stage II/III rectal cancer who had completed neoadjuvant 5-fluorouracil-based chemoradiation and had undergone complete resection were enrolled', 'Patients with Stage II or III Rectal Cancer Receiving Preoperative Chemoradiation']","['bevacizumab', 'mFOLFOX6', 'Postoperative Oxaliplatin, 5-Fluorouracil, and Leucovorin Versus Oxaliplatin, 5-Fluorouracil, Leucovorin, and Bevacizumab', 'bevacizumab to mFOLFOX6, following neoadjuvant chemoradiation and definitive surgery', 'mFOLFOX6 with bevacizumab']","['rate of treatment-related grade ≥\u20093 adverse events (AEs', 'OS', '5-year disease-free survival', 'overall survival (OS', 'neutropenia, leukopenia, neuropathy, diarrhea (without prior colostomy), and fatigue', '5-year overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0034896', 'cui_str': 'Rectum'}, {'cui': 'C0278484', 'cui_str': 'Colon cancer Dukes D'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009410', 'cui_str': 'Colostomy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",355.0,0.170331,"The rate of treatment-related grade ≥ 3 adverse events (AEs) was 68.8% on Arm A and 70.7% on Arm B. Arm B had a higher proportion of patients who discontinued therapy early as a result of AEs and patient withdrawal than did Arm A (32.4% vs. 21.5%,  ","[{'ForeName': 'A Bapsi', 'Initials': 'AB', 'LastName': 'Chakravarthy', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Fengmin', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'ECOG-ACRIN Biostatistics Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Neal J', 'Initials': 'NJ', 'LastName': 'Meropol', 'Affiliation': 'Flatiron Health, New York, New York, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Flynn', 'Affiliation': 'Abbott-Northwestern Hospital, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Wake Forest University Health Sciences, Winston Salem, North Carolina, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Sloan', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Diasio', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Edith P', 'Initials': 'EP', 'LastName': 'Mitchell', 'Affiliation': 'Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Catalano', 'Affiliation': 'ECOG-ACRIN Biostatistics Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Bruce J', 'Initials': 'BJ', 'LastName': 'Giantonio', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Catalano', 'Affiliation': 'Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Haller', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Rashid A', 'Initials': 'RA', 'LastName': 'Awan', 'Affiliation': 'University of Pittsburgh Cancer Institute (UPCI), Johnstown, Pennsylvania, USA.'}, {'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Mulcahy', 'Affiliation': 'Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': ""O'Brien"", 'Affiliation': 'Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Santala', 'Affiliation': 'Montana Cancer Consortium, Billings, Montana, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Cripps', 'Affiliation': 'Ottawa Health Research Institute-General Division, Ottawa, Ontario, Canada.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Weis', 'Affiliation': 'Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Atkins', 'Affiliation': 'Southeast Cancer Control Consortium, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Cynthia G', 'Initials': 'CG', 'LastName': 'Leichman', 'Affiliation': 'Laura and Issac Perlmutter Cancer Center at NYU Langone, New York, New York, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Petrelli', 'Affiliation': 'Delaware/Christiana Care NCORP, Newark, Delaware, USA.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Sinicrope', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Brierley', 'Affiliation': 'University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Tepper', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': ""O'Dwyer"", 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Elin R', 'Initials': 'ER', 'LastName': 'Sigurdson', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Stanley R', 'Initials': 'SR', 'LastName': 'Hamilton', 'Affiliation': 'MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Al B', 'Initials': 'AB', 'LastName': 'Benson', 'Affiliation': 'Northwestern University, Chicago, Illinois, USA.'}]",The oncologist,['10.1634/theoncologist.2019-0437']
1433,32411250,Efficacy of Vitamin E in Methotrexate-Induced Hepatotoxicity in Rheumatoid Arthritis: An Open-Label Case-Control Study.,"Objective


To examine the efficacy of vitamin E in methotrexate- (MTX-) induced transaminitis in patients with rheumatoid arthritis (RA).
Methods


A case-control study was conducted at a tertiary rheumatology center for 12 months. Patients with RA on MTX and deranged aminotransferases were included. Patients with previous liver diseases, baseline transaminitis before methotrexate initiation, alcohol intake, muscle diseases, under hepatotoxic drugs, and  aminotransferases  > 3 times the upper normal limit were excluded. The patients were divided into treatment (vitamin E 400 mg bid for 3 months) and control groups (no vitamin E) using a random number table. The dose of MTX was unaltered. Follow-up was done after 3 and 6 months. Independent  t -test was done to compare means of two groups. Paired  t -test was done to compare differences in mean.
Results


Among 230 patients, 86.5% were female with a mean BMI of 25.9 ± 4.5 kg/m 2 . In the treatment group, SGPT and SGOT at baseline were 73.1 ± 20.4 and 60.2 ± 24.5 IU/L, respectively; at 3-month follow-up 44.6 ± 34.2 and 38.3 ± 20.8 IU/L, respectively; and at 6-month follow-up 40.4 ± 35.7 and 34.2 ± 21.9 IU/L, respectively. In the control group, SGPT and SGOT at baseline were 63.4 ± 15.1 and 46.8 ± 13.7 IU/L, respectively, and at 3-month follow-up 55.8 ± 45.9 and 45.5 ± 30.9 IU/L, respectively. Significant decrease in the level of aminotransferases was seen in the treatment group ( p  value < 0.001) and not in the control group ( p  values 0.161 and 0.728, respectively). The change in levels of SGPT and SGOT from baseline to 3 months of follow-up was statistically significant in between two study groups ( p  values 0.007 and <0.001, respectively). From the control group, 29 patients were crossed over to vitamin E for the next 3 months. SGPT and SGOT decreased from 97.6 ± 44.1 to 46.1 ± 40.9 and 69.3 ± 34.9 to 29.1 ± 11.6 IU/L, respectively ( p  values 0.031 and 0.017, respectively).
Conclusion


Vitamin E significantly attenuates MTX-induced transaminitis.",2020,"Significant decrease in the level of aminotransferases was seen in the treatment group ( p  value < 0.001) and not in the control group ( p  values 0.161 and 0.728, respectively).","['patients with rheumatoid arthritis (RA', 'Patients with previous liver diseases, baseline transaminitis before methotrexate initiation, alcohol intake, muscle diseases, under hepatotoxic drugs, and  aminotransferases  > 3 times the upper normal limit were excluded', 'Patients with RA on MTX and deranged aminotransferases were included', 'Rheumatoid Arthritis', '230 patients, 86.5% were female with a mean BMI of 25.9 ± 4.5\u2009kg/m 2 ']","['vitamin E', 'vitamin E 400\u2009mg bid for 3 months) and control groups (no vitamin E', 'Methotrexate-Induced Hepatotoxicity', 'MTX', 'Vitamin E', 'vitamin E in methotrexate- (MTX']","['levels of SGPT and SGOT', 'SGPT and SGOT', 'level of aminotransferases']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2242708', 'cui_str': 'Hypertransaminasaemia'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0026848', 'cui_str': 'Disorder of muscle'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0442816', 'cui_str': 'Normal limits'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844009', 'cui_str': '4.5'}]","[{'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036828', 'cui_str': 'SGPT'}, {'cui': 'C0201899', 'cui_str': 'Aspartate aminotransferase measurement'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}]",29.0,0.0669268,"Significant decrease in the level of aminotransferases was seen in the treatment group ( p  value < 0.001) and not in the control group ( p  values 0.161 and 0.728, respectively).","[{'ForeName': 'Binit', 'Initials': 'B', 'LastName': 'Vaidya', 'Affiliation': 'National Center for Rheumatic Diseases (NCRD), Kathmandu, Nepal.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Bhochhibhoya', 'Affiliation': 'National Center for Rheumatic Diseases (NCRD), Kathmandu, Nepal.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Nakarmi', 'Affiliation': 'National Center for Rheumatic Diseases (NCRD), Kathmandu, Nepal.'}]",International journal of rheumatology,['10.1155/2020/5723485']
1434,32411218,A Scoping Review on the Attributes of Cluster Randomized Controlled Trials in Long-Term Care Facilities.,"Cluster randomized trial design, where groups of participants are randomized instead of individual participants, is increasingly being used in long-term care research. The purpose of this review was to determine the characteristics of cluster randomized trials in long-term care facilities. A medical librarian conducted the literature search. Two independent reviewers reviewed each paper. Studies were included if the design was cluster randomized and participants were from long-term care facilities. For each included study, two independent data extractors captured data on study attributes, including: journal, location, year published, author discipline, funding, methodology, number of participants, and intervention target. The literature search yielded 7,679 unique studies, with 195 studies meeting the selection criteria and being included for data extraction. The included studies were published between 1976 and 2017, with 53% of studies published after 2009. The term cluster randomized was in the title of only 45% of the studies. The studies were conducted worldwide; the United States had the largest number of studies (23%), followed by the United Kingdom (18%). Ten percent of studies were published in journals with an impact factor >10. The most frequent discipline of the first and last authors was medicine (34%), followed by nursing (17%). Forty-nine percent of the studies had government funding, while only 20% had medical industry funding. In studies with <1000 residents, 85% of the studies obtained consent from the resident and/or their proxy, while in studies with ≥ 1000 residents, it was 31%. The most frequent intervention targets were infection (13%), falls/fracture (13%), and behavior/physical restraint (13%). Cluster randomized controlled trials in long-term care have a unique set of characteristics. Results of this review will provide guidance to researchers conducting studies in long-term care facilities.",2020,"The most frequent discipline of the first and last authors was medicine (34%), followed by nursing (17%).","['Forty-nine percent of the studies had government funding, while only 20% had medical industry funding', '7,679 unique studies, with 195 studies meeting the selection criteria and being included for data extraction']",[],"['behavior/physical restraint', 'falls/fracture']","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0376244', 'cui_str': 'funding'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]",[],"[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]",,0.116288,"The most frequent discipline of the first and last authors was medicine (34%), followed by nursing (17%).","[{'ForeName': 'Roni Y', 'Initials': 'RY', 'LastName': 'Kraut', 'Affiliation': 'Department of Family Medicine, University of Alberta, Edmonton, Alberta, Canada T6G 2T4.'}, {'ForeName': 'Lauren S', 'Initials': 'LS', 'LastName': 'Katz', 'Affiliation': 'Winnipeg Public Library, Winnipeg, Manitoba, Canada R3C 3P5.'}, {'ForeName': 'Oksana', 'Initials': 'O', 'LastName': 'Babenko', 'Affiliation': 'Department of Family Medicine, University of Alberta, Edmonton, Alberta, Canada T6G 2T4.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'Diaz Carvallo', 'Affiliation': 'Department of Family Medicine, University of Alberta, Edmonton, Alberta, Canada T6G 2T4.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Alexanders', 'Affiliation': 'Department of Family Medicine, University of Alberta, Edmonton, Alberta, Canada T6G 2T4.'}, {'ForeName': 'Derek S', 'Initials': 'DS', 'LastName': 'Chan', 'Affiliation': 'Department of Family Medicine, University of Alberta, Edmonton, Alberta, Canada T6G 2T4.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Campbell', 'Affiliation': 'John W. Scott Health Sciences, University of Alberta, Edmonton, Alberta, Canada T6G 2R7.'}, {'ForeName': 'Dean T', 'Initials': 'DT', 'LastName': 'Eurich', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Alberta, Canada T6G 2G3.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Garrison', 'Affiliation': 'Department of Family Medicine, University of Alberta, Edmonton, Alberta, Canada T6G 2T4.'}]",Current gerontology and geriatrics research,['10.1155/2020/6085368']
1435,32411217,Balance as an Additional Effect of Strength and Flexibility Aquatic Training in Sedentary Lifestyle Elderly Women.,"Objective


To evaluate the additional effects of on balance an aquatic muscle strengthening and flexibility training program in healthy sedentary lifestyle elderly women.
Method


This controlled clinical trial included 56 healthy sedentary women, aged from 65 to 70 years, divided into two groups. The aquatic group (AG) underwent aquatic training (45 minutes/session, 32 sessions), and the control group (CG) received no intervention. Data were collected pre- and post-intervention, during a one-week period. Lower limb muscle strength was measured by a force sensor (myometer). Flexibility was measured by biophotogrammetry. Functional balance was evaluated by the Performance Oriented Mobility Assessment (POMA) and the Berg Balance Scale (BBS).
Results


Muscle strength, flexibility, and balance improved in AG ( p  < 0.001), but not in CG.
Conclusion


The aquatic exercises program, which was originally developed to promote muscle strength and flexibility, also improved functional balance. Aquatic training is an option for physical health promotion for sedentary lifestyle elderly women.",2020,"Results


Muscle strength, flexibility, and balance improved in AG ( p  < 0.001), but not in CG.
","['Sedentary Lifestyle Elderly Women', 'sedentary lifestyle elderly women', 'healthy sedentary lifestyle elderly women', '56 healthy sedentary women, aged from 65 to 70 years, divided into two groups']","['Aquatic training', 'Strength and Flexibility Aquatic Training', 'control group (CG) received no intervention', 'aquatic training', 'aquatic muscle strengthening and flexibility training program']","['Muscle strength, flexibility, and balance improved in AG', 'Performance Oriented Mobility Assessment (POMA) and the Berg Balance Scale (BBS', 'Lower limb muscle strength', 'Flexibility', 'Functional balance']","[{'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C2317515', 'cui_str': 'Assessment of mobility'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",56.0,0.010815,"Results


Muscle strength, flexibility, and balance improved in AG ( p  < 0.001), but not in CG.
","[{'ForeName': 'Fernando Alves', 'Initials': 'FA', 'LastName': 'Vale', 'Affiliation': 'PT, MSc. Rehabilitation Sciences Post Graduation Program of Medical School of University of São Paulo, Laboratory of Physical Therapy and Behavior, São Paulo, Brazil.'}, {'ForeName': 'Mariana Callil', 'Initials': 'MC', 'LastName': 'Voos', 'Affiliation': 'Professor at Ibirapuera University, Physical Therapy Course, São Paulo, Brazil.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Brumini', 'Affiliation': 'Professor at Ibirapuera University, Physical Therapy Course, São Paulo, Brazil.'}, {'ForeName': 'Eneida Yuri', 'Initials': 'EY', 'LastName': 'Suda', 'Affiliation': 'Professor at Ibirapuera University, Physical Therapy Course, São Paulo, Brazil.'}, {'ForeName': 'Ronaldo Luis', 'Initials': 'RL', 'LastName': 'da Silva', 'Affiliation': 'PT, MSc. Faculté des Sciences, Université du Québec à Montréal, Quebec, Canada.'}, {'ForeName': 'Fátima Aparecida', 'Initials': 'FA', 'LastName': 'Caromano', 'Affiliation': 'PT, PhD. Rehabilitation Sciences Post Graduation Program of Medical School of University of São Paulo, Laboratory of Physical Therapy and Behavior, São Paulo, Brazil.'}]",Current gerontology and geriatrics research,['10.1155/2020/1895473']
1436,32411054,Impact of Music on Working Memory in Rwanda.,"Previous research shows that listening to pleasant, stimulating and familiar music is likely to improve working memory performance. The benefits of music on cognition have been widely studied in Western populations, but not in other cultures. The purpose of this study was to explore the impact of music on working memory in a non-Western sociocultural context: Rwanda. One hundred and nineteen participants were randomly assigned to a control group (short story) or one of four different musical conditions varying on two dimensions: arousal (relaxing, stimulating) and cultural origin (Western, Rwandan). Working memory was measured using a behavioral task, the n-back paradigm, before and after listening to music (or the short story in the control condition). Unlike in previous studies with Western samples, our results with this Rwandan sample did not show any positive effect of familiar, pleasant and stimulating music on working memory. Performance on the n-back task generally improved from pre to post, in all conditions, but this improvement was less important in participants who listened to familiar Rwandan music compared to those who listened to unfamiliar Western music or to a short story. The study highlights the importance of considering the sociocultural context in research examining the impact of music on cognition. Although different aspects of music are considered universal, there may be cultural differences that limit the generalization of certain effects of music on cognition or that modulate the characteristics that favor its beneficial impact.",2020,"Performance on the n-back task generally improved from pre to post, in all conditions, but this improvement was less important in participants who listened to familiar Rwandan music compared to those who listened to unfamiliar Western music or to a short story.","['Rwanda', 'One hundred and nineteen participants']","['control group (short story) or one of four different musical conditions varying on two dimensions: arousal (relaxing, stimulating) and cultural origin (Western, Rwandan']","['positive effect of familiar, pleasant and stimulating music on working memory', 'working memory performance']","[{'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",119.0,0.131243,"Performance on the n-back task generally improved from pre to post, in all conditions, but this improvement was less important in participants who listened to familiar Rwandan music compared to those who listened to unfamiliar Western music or to a short story.","[{'ForeName': 'Sara-Valérie', 'Initials': 'SV', 'LastName': 'Giroux', 'Affiliation': 'Groupe de Recherche CogNAC, Département de Psychologie, Université du Québec à Trois-Rivières, Trois-Rivières, Québec, QC, Canada.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Caparos', 'Affiliation': 'DysCo Laboratory, Département de Psychologie, Université Paris 8, Saint-Denis, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Gosselin', 'Affiliation': 'Groupe de Recherche CogNAC, Département de Psychologie, Université du Québec à Trois-Rivières, Trois-Rivières, Québec, QC, Canada.'}, {'ForeName': 'Eugène', 'Initials': 'E', 'LastName': 'Rutembesa', 'Affiliation': 'College of Medicine and Health Sciences, University of Rwanda, Kigali, Rwanda.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Blanchette', 'Affiliation': 'Groupe de Recherche CogNAC, Département de Psychologie, Université du Québec à Trois-Rivières, Trois-Rivières, Québec, QC, Canada.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00774']
1437,32411212,Efficacy of Tamsulosin plus Tadalafil versus Tamsulosin as Medical Expulsive Therapy for Lower Ureteric Stones: A Randomized Controlled Trial.,"Introduction


Urolithiasis is one of the common disorder with which about 1/5 th  is found in the ureter, of which 2/3 rd  is seen in the lower ureter. Medical expulsive therapy is one of the routine modalities of treatment which uses various drugs acting on the ureter smooth muscle by different mechanism. We aim to compare the efficacy of combination vs. single drug.
Methods


This randomized controlled trial was done in 176 consecutive patients over a period of six months (March 2019 to August 2019) in Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching. Participants were divided into two groups (Group A, tamsulosin plus tadalafil, and Group B, tamsulosin) from computer-generated random numbers. Therapy was continued for a maximum of 3 weeks. Stone expulsion rate, time to stone expulsion, analgesic use, number of colic and emergency room visits for pain, early intervention, and adverse effects of drugs were recorded.
Results


Among 176 patients who were enrolled in study, 7 were lost to follow-up, and 5 people required immediate intervention. There was a significant higher stone passage rate in group A than group B (64 vs. 50;  P =0.025) and shorter expulsion time (1.66 vs. 2.32 weeks  P =0.001) and less number of emergency room visits and colic episodes. No significant side effects were noted during study.
Conclusion


Tamsulosin plus Tadalafil is more effective than tamsulosin with early passage of stone and decreased number of colic episodes and emergency visits without significant side effects for lower ureteric calculi of 5 mm to 10 mm.",2020,There was a significant higher stone passage rate in group A than group B (64 vs. 50;  P =0.025) and shorter expulsion time (1.66 vs. 2.32 weeks  P =0.001) and less number of emergency room visits and colic episodes.,"['176 consecutive patients over a period of six months (March 2019 to August 2019) in Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching', '176 patients who were enrolled in study, 7 were lost to follow-up, and 5 people required immediate intervention', 'Lower Ureteric Stones']","['tamsulosin', 'Tamsulosin', 'combination vs. single drug', 'tamsulosin plus tadalafil, and Group B, tamsulosin', 'Tamsulosin plus Tadalafil']","['shorter expulsion time', 'stone passage rate', 'number of emergency room visits and colic episodes', 'Stone expulsion rate, time to stone expulsion, analgesic use, number of colic and emergency room visits for pain, early intervention, and adverse effects of drugs', 'side effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0303134', 'cui_str': 'Beryllium-7'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0232488', 'cui_str': 'Abdominal colic'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",176.0,0.0783319,There was a significant higher stone passage rate in group A than group B (64 vs. 50;  P =0.025) and shorter expulsion time (1.66 vs. 2.32 weeks  P =0.001) and less number of emergency room visits and colic episodes.,"[{'ForeName': 'Diwas', 'Initials': 'D', 'LastName': 'Gnyawali', 'Affiliation': 'Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital, Institute of Medicine, Maharajgung, Kathmandu 44600, Nepal.'}, {'ForeName': 'Manish Man', 'Initials': 'MM', 'LastName': 'Pradhan', 'Affiliation': 'Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital, Institute of Medicine, Maharajgung, Kathmandu 44600, Nepal.'}, {'ForeName': 'Prem Raj', 'Initials': 'PR', 'LastName': 'Sigdel', 'Affiliation': 'Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital, Institute of Medicine, Maharajgung, Kathmandu 44600, Nepal.'}, {'ForeName': 'Purushottam', 'Initials': 'P', 'LastName': 'Parajuli', 'Affiliation': 'Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital, Institute of Medicine, Maharajgung, Kathmandu 44600, Nepal.'}, {'ForeName': 'Sampanna', 'Initials': 'S', 'LastName': 'Chudal', 'Affiliation': 'Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital, Institute of Medicine, Maharajgung, Kathmandu 44600, Nepal.'}, {'ForeName': 'Sujeet', 'Initials': 'S', 'LastName': 'Poudyal', 'Affiliation': 'Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital, Institute of Medicine, Maharajgung, Kathmandu 44600, Nepal.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Chapagain', 'Affiliation': 'Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital, Institute of Medicine, Maharajgung, Kathmandu 44600, Nepal.'}, {'ForeName': 'Bhoj Raj', 'Initials': 'BR', 'LastName': 'Luitel', 'Affiliation': 'Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital, Institute of Medicine, Maharajgung, Kathmandu 44600, Nepal.'}, {'ForeName': 'Pawan Raj', 'Initials': 'PR', 'LastName': 'Chalise', 'Affiliation': 'Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital, Institute of Medicine, Maharajgung, Kathmandu 44600, Nepal.'}, {'ForeName': 'Uttam', 'Initials': 'U', 'LastName': 'Sharma', 'Affiliation': 'Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital, Institute of Medicine, Maharajgung, Kathmandu 44600, Nepal.'}, {'ForeName': 'Prem Raj', 'Initials': 'PR', 'LastName': 'Gyawali', 'Affiliation': 'Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital, Institute of Medicine, Maharajgung, Kathmandu 44600, Nepal.'}]",Advances in urology,['10.1155/2020/4347598']
1438,32411082,Remote Ischemic Conditioning for Intracerebral Hemorrhage (RICH-1): Rationale and Study Protocol for a Pilot Open-Label Randomized Controlled Trial.,"Background and rationale:  Although many therapies have been investigated for intracerebral hemorrhage (ICH), none have succeeded in improving the functional outcomes. Remote ischemic conditioning (RIC) has been proven to promote hematoma resolution and improve neurological outcomes in an ICH model; whether it is safe and feasible in patients with ICH remains unknown. This trial aims to assess the safety, feasibility, and preliminary efficacy of RIC in patients with ICH and to plan for a phase-2 study.  Methods:  A proof-of-concept, assessor-blinded, pilot open-label randomized controlled trial will be carried out with patients with ICH within 24-48 h of ictus. All participants will be randomly allocated to the intervention group and the control group with a 1:1 ratio ( n  = 20) and will be treated with standard managements according to the guidelines. Participants allocated to the intervention group will receive RIC once daily for 7 consecutive days. Cranial computed tomography examinations will be performed at baseline, and on days 3, 7, and 14. Neurological outcomes will be assessed at baseline, and on days 1 to 14, 30, and 90. The primary outcome to be tested is safety. Secondary tested outcomes include changes of hematoma and perihematomal edema volume, incidence of hematoma expansion, functional outcomes, and frequency of adverse events.  Discussions:  This study will be the first proof-of-concept randomized controlled trial to ascertain the safety, feasibility, and preliminary efficacy of RIC in patients with ICH, results of which will provide parameters for future studies and provide insights into the treatment of ICH.  Trial Registration:  Clinicaltrials.gov, identifier: NCT03930940.",2020,"Secondary tested outcomes include changes of hematoma and perihematomal edema volume, incidence of hematoma expansion, functional outcomes, and frequency of adverse events.  ","['Intracerebral Hemorrhage (RICH-1', 'patients with ICH', 'patients with ICH and to plan for a phase-2 study', 'patients with ICH within 24-48 h of ictus']","['Remote ischemic conditioning (RIC', 'Remote Ischemic Conditioning', 'RIC']","['changes of hematoma and perihematomal edema volume, incidence of hematoma expansion, functional outcomes, and frequency of adverse events', 'Neurological outcomes']","[{'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}]",,0.149228,"Secondary tested outcomes include changes of hematoma and perihematomal edema volume, incidence of hematoma expansion, functional outcomes, and frequency of adverse events.  ","[{'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Sijie', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Beijing Key Laboratory of Hypoxic Conditioning Translational Medicine, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Chuanjie', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Gu', 'Affiliation': 'Department of Neurology, Ningjin County Hospital, Xingtai, China.'}, {'ForeName': 'Quanzhong', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurosurgery, Heze Municipal Hospital, Heze, China.'}, {'ForeName': 'Xinjing', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Neurosurgery, The Sixth Hospital of Hengshui, Hengshui, China.'}, {'ForeName': 'Zongen', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'Department of Neurology, Shengli Oilfield Central Hospital, Dongying, China.'}, {'ForeName': 'Haiqing', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xunming', 'Initials': 'X', 'LastName': 'Ji', 'Affiliation': 'Beijing Key Laboratory of Hypoxic Conditioning Translational Medicine, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Frontiers in neurology,['10.3389/fneur.2020.00313']
1439,29706170,A randomized clinical trial of motivational enhancement therapy for alcohol problems in partner violent men.,"This study examined the efficacy of brief alcohol intervention in the context of community-based treatment for partner violence. In a randomized clinical trial, 228 partner-violent men with hazardous or problem drinking were recruited at three Intimate Partner Violence (IPV) treatment agencies and randomly assigned to receive one of two 4-session alcohol interventions: Motivational Enhancement Therapy (MET: N = 110) or Alcohol Education (AE: N = 118). After completing alcohol intervention, participants received standard agency counseling services for IPV. Participants completed assessments of alcohol use, drug use, and IPV at pre-treatment, post-alcohol intervention, and quarterly follow-ups for 12 months. At the end of the 4-session alcohol intervention, MET participants displayed greater acknowledgment of problems with alcohol than AE participants (Partial ή 2  = 0.039, p = 0.006). Significant changes from baseline across treatment conditions (at p < 0.001) were observed for percent days of alcohol abstinence [95% empirical CI for Partial ή 2  =0.226, 0.296], heavy drinking [0.292, 0.349], illicit drug use [0.096, 0.156] and partner violence [0.282, 0.334]. No significant condition differences (treatment by time interactions) were found for alcohol abstinence [95% empirical CI for Partial ή 2  = 0.007, 0.036], heavy drinking [0.016, 0.055], illicit drug use [0.005, 0.035] or partner violence [0.001, 0.004]. Results encourage continued use of brief alcohol interventions in community IPV services, but do not provide evidence of a unique benefit of MET in reducing alcohol use in this population.",2018,"Significant changes from baseline across treatment conditions (at p < 0.001) were observed for percent days of alcohol abstinence [95% empirical CI for Partial ή 2  =0.226, 0.296], heavy drinking [0.292, 0.349], illicit drug use [0.096, 0.156] and partner violence [0.282, 0.334].","['partner violence', '228 partner-violent men with hazardous or problem drinking were recruited at three Intimate Partner Violence (IPV) treatment agencies and randomly assigned to receive one of two', 'partner violent men']","['standard agency counseling services for IPV', '4-session alcohol interventions: Motivational Enhancement Therapy (MET: N\u202f=\u202f110) or Alcohol Education (AE: N\u202f=\u202f118', 'motivational enhancement therapy', 'alcohol intervention']","['acknowledgment of problems with alcohol', 'alcohol abstinence']","[{'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0242151', 'cui_str': 'Violent'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0542296', 'cui_str': 'Counselling service'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0678274', 'cui_str': 'Abstinences, Alcohol'}]",228.0,0.0297648,"Significant changes from baseline across treatment conditions (at p < 0.001) were observed for percent days of alcohol abstinence [95% empirical CI for Partial ή 2  =0.226, 0.296], heavy drinking [0.292, 0.349], illicit drug use [0.096, 0.156] and partner violence [0.282, 0.334].","[{'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Murphy', 'Affiliation': 'University of Maryland, Baltimore County, United States. Electronic address: chmurphy@umbc.edu.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Ting', 'Affiliation': 'University of Maryland, Baltimore County, United States.'}, {'ForeName': 'Lisa C', 'Initials': 'LC', 'LastName': 'Jordan', 'Affiliation': 'University of Maryland, Baltimore County, United States.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Musser', 'Affiliation': 'University of Maryland, Baltimore County, United States.'}, {'ForeName': 'Jamie J', 'Initials': 'JJ', 'LastName': 'Winters', 'Affiliation': 'University of Maryland, Baltimore County, United States.'}, {'ForeName': 'Gina M', 'Initials': 'GM', 'LastName': 'Poole', 'Affiliation': 'University of Maryland, Baltimore County, United States.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Pitts', 'Affiliation': 'University of Maryland, Baltimore County, United States.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2018.03.004']
1440,31586784,A randomized-controlled trial to assess the effect of ibuprofen on postpartum blood pressure in women with hypertensive disorders of pregnancy.,"OBJECTIVES


To test the hypothesis that ibuprofen is equivalent to acetaminophen in its effect on postpartum blood pressure in women with gestational hypertension or preeclampsia without severe features.
STUDY DESIGN


Single-center randomized, crossover, equivalence trial among women with hypertensive disorders of pregnancy without severe features after vaginal delivery. Participants were assigned in a double-blind fashion to ibuprofen 600 mg or acetaminophen 650 mg every 6 h for 24 h followed by crossover to the other drug. We assessed clinical blood pressures and ambulatory blood pressure monitor measurements. Intention-to-treat analyses were performed using a linear mixed model adjusted for time period.
MAIN OUTCOME MEASURES


The mean difference in systolic blood pressure through 24 h of drug exposure with an equivalence margin of 10 mmHg.
RESULTS


Of 185 screened women, 74 enrolled prior to delivery. Forty-three women remained eligible and were randomized to ibuprofen first (n = 20, 46.5%) or acetaminophen first (n = 23, 53.5%). A total of 37 women (86.0%) received study drug (ibuprofen first n = 19, acetaminophen first n = 18). Most participants were white (91.9%) and had gestational hypertension (86.5%); mean (SD) age was 31.0 (6.5) years. The mean adjusted difference in systolic blood pressure was 1.0 mmHg (95% CI, -3.7 to 5.7 mmHg), which was within the equivalence margin. A linear mixed model did not demonstrate a main effect of group assignment, nor did it show an interaction effect with time period.
CONCLUSIONS


Among women with gestational hypertension and preeclampsia without severe features, ibuprofen is an equally safe option as acetaminophen with respect to postpartum blood pressure concerns.",2019,"A linear mixed model did not demonstrate a main effect of group assignment, nor did it show an interaction effect with time period.
","['Forty-three women remained eligible', 'women with gestational hypertension or preeclampsia without severe features', 'women with gestational hypertension and preeclampsia without severe features', '185 screened women', 'women with hypertensive disorders of pregnancy', '74 enrolled prior to delivery', 'Most participants were white (91.9%) and had gestational hypertension (86.5%); mean (SD) age was 31.0 (6.5) years', 'women with hypertensive disorders of pregnancy without severe features after vaginal delivery', '37 women (86.0%) received']","['acetaminophen', 'study drug (ibuprofen first n\u202f=\u202f19, acetaminophen', 'ibuprofen', 'ibuprofen 600\u202fmg or acetaminophen']","['clinical blood pressures and ambulatory blood pressure monitor measurements', 'systolic blood pressure', 'postpartum blood pressure']","[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0852036', 'cui_str': 'Hypertension, Pregnancy-Induced'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C1600132', 'cui_str': 'Ibuprofen 600 MG [Ibu]'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0005825', 'cui_str': 'Continuous Sphygmomanometers'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]",74.0,0.348068,"A linear mixed model did not demonstrate a main effect of group assignment, nor did it show an interaction effect with time period.
","[{'ForeName': 'Jourdan E', 'Initials': 'JE', 'LastName': 'Triebwasser', 'Affiliation': 'Department of Obstetrics & Gynaecology, Division of Maternal-Fetal Medicine, Michigan Medicine, University of Michigan, L4000 University Hospital South, 1500 East Medical Center Drive, Ann Arbor, MI 48109-5276, United States. Electronic address: Jourdan.triebwasser@pennmedicine.upenn.edu.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Hesson', 'Affiliation': 'Department of Obstetrics & Gynaecology, Division of Maternal-Fetal Medicine, Michigan Medicine, University of Michigan, L4000 University Hospital South, 1500 East Medical Center Drive, Ann Arbor, MI 48109-5276, United States. Electronic address: ahesson@med.umich.edu.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Langen', 'Affiliation': 'Department of Obstetrics & Gynaecology, Division of Maternal-Fetal Medicine, Michigan Medicine, University of Michigan, L4000 University Hospital South, 1500 East Medical Center Drive, Ann Arbor, MI 48109-5276, United States. Electronic address: elangen@med.umich.edu.'}]",Pregnancy hypertension,['10.1016/j.preghy.2019.09.012']
1441,32411262,Assessment of the Effects of Inspiratory Muscle Training (IMT) and Aerobic Training on the Quality of Life of Patients with Chronic Obstructive Pulmonary Disease.,"Background


Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. The aim of this study was to investigate the effects of inspiratory muscle training (IMT) and aerobic exercise on health-related quality of life of patients with COPD.
Materials and Methods


This randomized controlled clinical trial was conducted on 60 patients with moderate to severe COPD, who were referred to Imam Hossein Hospital of Tehran, Iran in 2016. The patients were randomly assigned to four groups and treated for eight weeks. Group 1 (n=16) participated in 16 sessions of IMT (15 minutes per session), group 2 (n=14) performed aerobic exercises twice a week (40 minutes per session), group 3 (n=15) performed IMT and aerobic exercises, and group 4 (n=15) received no intervention, except for routine treatments (control). Quality of life was evaluated based on the Saint George's Respiratory Questionnaire (SGRQ) at baseline, week 4, and week 8 after the intervention.
Results


After eight weeks, all four groups experienced a significant improvement in their quality of life (P<0.05), and group 3 (IMT and aerobic exercise) showed the greatest improvement. However, quality of life improvement in group 4 (control) was less than the other three groups (P<0.05).
Conclusion


Aerobic exercise and IMT were more effective than routine protocols in improving the quality of life of COPD patients. Furthermore, short-term IMT plus aerobic exercise had the greatest impact on improving the health-related quality of life of COPD patients and could be used in the management of these patients.",2019,"After eight weeks, all four groups experienced a significant improvement in their quality of life (P<0.05), and group 3 (IMT and aerobic exercise) showed the greatest improvement.","['patients with COPD', '60 patients with moderate to severe COPD, who were referred to Imam Hossein Hospital of Tehran, Iran in 2016', '\n\n\nChronic obstructive pulmonary disease (COPD', 'Patients with Chronic Obstructive Pulmonary Disease']","['Inspiratory Muscle Training (IMT) and Aerobic Training', 'inspiratory muscle training (IMT) and aerobic exercise', 'IMT and aerobic exercises, and group 4 (n=15) received no intervention, except for routine treatments (control', 'Aerobic exercise and IMT', 'aerobic exercises', 'IMT']","['quality of life', 'Quality of Life', 'health-related quality of life', 'quality of life improvement', 'Quality of life', ""Saint George's Respiratory Questionnaire (SGRQ""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332300', 'cui_str': 'Except for'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0242823', 'cui_str': 'Saints'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",60.0,0.0287239,"After eight weeks, all four groups experienced a significant improvement in their quality of life (P<0.05), and group 3 (IMT and aerobic exercise) showed the greatest improvement.","[{'ForeName': 'Amir Hossein', 'Initials': 'AH', 'LastName': 'Abedi Yekta', 'Affiliation': 'Department of Sports Medicine, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehrshad', 'Initials': 'M', 'LastName': 'Poursaeid Esfahani', 'Affiliation': 'Department of Sports Medicine, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Salehi', 'Affiliation': 'Department of Sports Medicine, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hassabi', 'Affiliation': 'Department of Sports Medicine, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Khosravi', 'Affiliation': 'Department of Sports Medicine, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Kharabian', 'Affiliation': 'Department of Sports Medicine, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Sohrabi', 'Affiliation': 'Department of Sports Medicine, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir Ali', 'Initials': 'AA', 'LastName': 'Mafi', 'Affiliation': 'Clinical Research Development Center of Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Rezaei', 'Affiliation': 'Department of Sports Medicine, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Tanaffos,[]
1442,31876749,Clinical observation of bronchoscopy alveolar lavage combined with thoracoscopy in the treatment of empyema in children.,"The objective of this study was to investigate the therapeutic effects of bronchoscopy alveolar lavage (BAL) combined with thoracoscopy in the treatment of empyema in children.Retrospectively analyzed 174 cases of pediatric empyema treated with thoracoscopy combined with BAL from January 2010 to December 2016 in our hospital. All the cases, according to admission order, were randomly divided into 2 groups, the control group (group A), which contained 89 cases, was treated with thoracoscopy; and the experimental group (group B), which contained 85 cases, was treated with BAL combined with thoracoscopy. The results of BAL treatment, the inflammatory indexes including body temperature, total leukocyte count in peripheral blood and CRP, and the therapeutic effect and prognosis including the days of antibiotic use, hospital stay, the incidence of thoracotomy and lobectomy were compared between the 2 groups.There was statistical difference in all the therapeutic indexes (P < .05).Bronchoscopy alveolar lavage combined with thoracoscopy has a higher success rate in the treatment of pediatric empyema, and is more comprehensive, safe and effective in controlling inflammation.",2019,There was statistical difference in all the therapeutic indexes (P < .05).Bronchoscopy,"['Retrospectively analyzed 174 cases of pediatric empyema treated with thoracoscopy combined with BAL from January 2010 to December 2016 in our hospital', 'empyema in children']","['alveolar lavage combined with thoracoscopy', 'thoracoscopy', 'bronchoscopy alveolar lavage combined with thoracoscopy', 'BAL combined with thoracoscopy', '05).Bronchoscopy', 'bronchoscopy alveolar lavage (BAL) combined with thoracoscopy']","['body temperature, total leukocyte count in peripheral blood and CRP, and the therapeutic effect and prognosis including the days of antibiotic use, hospital stay, the incidence of thoracotomy and lobectomy']","[{'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0014009', 'cui_str': 'Empyema'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0039989', 'cui_str': 'Pleural Endoscopy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0012383', 'cui_str': 'Dimercaprol'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0039989', 'cui_str': 'Pleural Endoscopy'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C0012383', 'cui_str': 'Dimercaprol'}]","[{'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C1527144'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0039991', 'cui_str': 'Thoracotomy'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland (procedure)'}]",,0.0146992,There was statistical difference in all the therapeutic indexes (P < .05).Bronchoscopy,"[{'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yue', 'Affiliation': ''}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Yanfang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Feifei', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000018528']
1443,32038332,Delivery of Family-Based Treatment for Adolescent Anorexia Nervosa in a Public Health Care Setting: Research Versus Non-Research Specialty Care.,"Comparing evidence-based psychotherapy (EBP) to usual care typically demonstrates the superiority of EBPs, although this has not been studied for eating disorders EBPs such as family-based treatment (FBT). The current study set out to examine weight outcomes for adolescents with anorexia nervosa who received FBT through a randomized clinical research trial (RCT,  n  = 54) or non-research specialty care ( n  = 56) at the same specialist pediatric eating disorder service. Weight was recorded throughout outpatient treatment (up to 18 sessions over 6 months), as well as at 6- and 12-month follow-up. Survival curves were used to examine time to weight restoration [greater than 95% median body mass index (mBMI)] as predicted by type of care (RCT vs. non-research specialty care), baseline clinical and demographic characteristics, and their potential interaction. Results did not indicate a significant main effect for type of care, but there was a significant effect for baseline weight ( p  = .03), such that weight restoration was achieved faster across both treatment types for those with a higher initial %mBMI. These data suggest that weight restoration achieved in non-research specialty care FBT was largely similar to that achieved in a controlled research trial.
Clinical Trial Registration


http://www.anzctr.org.au/, identifier ACTRN12610000216011.",2019,"Results did not indicate a significant main effect for type of care, but there was a significant effect for baseline weight ( p  = .03), such that weight restoration was achieved faster across both treatment types for those with a higher initial %mBMI.","['adolescents with anorexia nervosa who received FBT through a randomized clinical research trial (RCT,  n  = 54) or non-research specialty care ( n  = 56) at the same specialist pediatric eating disorder service', 'Adolescent Anorexia Nervosa']",['evidence-based psychotherapy (EBP'],"['Survival curves', 'weight restoration', 'Weight', 'baseline weight']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}]",,0.0478539,"Results did not indicate a significant main effect for type of care, but there was a significant effect for baseline weight ( p  = .03), such that weight restoration was achieved faster across both treatment types for those with a higher initial %mBMI.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Le Grange', 'Affiliation': 'Department of Psychiatry, UCSF Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Gorrell', 'Affiliation': 'Department of Psychiatry, UCSF Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Elizabeth K', 'Initials': 'EK', 'LastName': 'Hughes', 'Affiliation': 'Department of Paediatrics, The University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Erin C', 'Initials': 'EC', 'LastName': 'Accurso', 'Affiliation': 'Department of Psychiatry, UCSF Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Yeo', 'Affiliation': 'Department of Paediatrics, The University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Pradel', 'Affiliation': 'Department of Paediatrics, The University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sawyer', 'Affiliation': 'Department of Paediatrics, The University of Melbourne, Melbourne, VIC, Australia.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2019.01001']
1444,32411260,"Cromolyn, a New Hope for Limited Treatment of Neutrophilic Asthma: a Phase II Randomized Clinical Trial.","Background


In this study, we aimed to determine the effects of cromolyn on the clinical outcomes and neutrophilic inflammation in patients with resistant cough-variant asthma.
Materials and Methods


Patients with cough-variant asthma, with normal physical examination and spirometry results, were treated by inhaled corticosteroids, antileukotrienes, antibiotics, and proton-pump inhibitors according to the Global Initiative for Asthma (GINA) guidelines. Seventy patients, who were resistant to these treatments, were enrolled in this double-blind randomized clinical trial. After randomization, eligible subjects received a cromolyn metered dose inhaler (MDI) or a placebo MDI, which was completely similar in appearance to the cromolyn inhaler. The primary outcomes included cough and Asthma Control Test (ACT) score.
Results


Based on the findings, cough significantly decreased with cromolyn therapy, compared to the placebo group. Other clinical findings, including dyspnea, sputum production, and nocturnal symptoms, also improved. The ACT score significantly improved to a nearly normal level (23.53±2.25) in the cromolyn group. Moreover, fractional exhaled nitric oxide (FeNO) significantly decreased with cromolyn treatment (14±9.31 ppm after treatment vs. 28.88±27.39 before treatment). The neutrophil count significantly decreased in the cromolyn group (from 44±24.2% before the trial to 34.08±16.7% after the trial), while it increased in the placebo group (from 39.67±26.47% to 56.71±27.22%).
Conclusion


Cromolyn improved the clinical findings of resistant cough-variant asthma and could suppress neutrophilic inflammation.",2019,The ACT score significantly improved to a nearly normal level (23.53±2.25) in the cromolyn group.,"['Seventy patients, who were resistant to these treatments', 'Patients with cough-variant asthma, with normal physical examination and spirometry results', 'Neutrophilic Asthma', 'patients with resistant cough-variant asthma']","['cromolyn metered dose inhaler (MDI) or a placebo MDI', 'cromolyn', 'inhaled corticosteroids, antileukotrienes, antibiotics, and proton-pump inhibitors according to the Global Initiative for Asthma (GINA) guidelines', 'placebo']","['neutrophil count', 'fractional exhaled nitric oxide (FeNO', 'dyspnea, sputum production, and nocturnal symptoms', 'ACT score', 'cough and Asthma Control Test (ACT) score']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0694548', 'cui_str': 'Cough variant asthma'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C2363774', 'cui_str': 'Neutrophilic asthma'}]","[{'cui': 'C1967783', 'cui_str': 'Cromolyn Metered Dose Inhaler'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086073', 'cui_str': 'Cromolyn'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",70.0,0.306888,The ACT score significantly improved to a nearly normal level (23.53±2.25) in the cromolyn group.,"[{'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mirsadraee', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Islamic Azad University, Mashhad Branch, Mashhad, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Sabbagh Sajadieh', 'Affiliation': 'Department of Internal Medicine, Golestan University of Medical Sciences, Sayyad Shirazi Hospital, Gorgan, Iran.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Ghafari', 'Affiliation': 'Shahid Hashemi Nezhad Research Center, Ministry of Education, Mashhad, Iran.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Tavakoli', 'Affiliation': 'Independent Pharmacist, Mashhad, Iran.'}, {'ForeName': 'Saeedeh', 'Initials': 'S', 'LastName': 'Sabbagh Sajadieh', 'Affiliation': 'Department of Pathology, Taleghani Medical Institute and Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Tanaffos,[]
1445,31542640,Influence of sex on chemotherapy efficacy and toxicity in oesophagogastric cancer: A pooled analysis of four randomised trials.,"BACKGROUND


Sex contributes to interpatient variability of chemotherapy metabolism and dose response, potentially influencing both efficacy and toxicity; however, comparative data on its effect on oesophagogastric cancer are lacking.
PATIENTS AND METHODS


Data for patients with advanced oesophagogastric cancer randomised to comparable first-line chemotherapy regimens within four United Kingdom prospective trials were pooled, and key demographic and outcome measures were compared between males and females.
RESULTS


A total of 1654 patients were included: 1328 (80.3%) males and 326 (19.7%) females. Female patients were younger, had a significantly higher proportion of gastric tumours as opposed to junctional or oesophageal tumours and experienced significantly higher rates of a number of toxicities including nausea and vomiting, diarrhoea, stomatitis and alopecia. When adjusting for potential confounding factors, the risk of female patients experiencing grade ≥III gastrointestinal toxicity was greater (adjusted odds ratio = 1.50; 95% confidence interval = 1.07-2.12). Females also had a significantly higher incidence of serious adverse events on treatment and received comparatively less cycles of chemotherapy overall than males.
CONCLUSIONS


This represents the largest pooled analysis of the effect of sex on chemotherapy outcome and toxicity in advanced oesophagogastric cancer. The differential toxicity and adverse event rates observed suggest that sex may be an important modulator of treatment tolerability and safety in this tumour type.",2019,gastrointestinal toxicity was greater (adjusted odds ratio = 1.50; 95% confidence interval = 1.07-2.12).,"['A total of 1654 patients were included: 1328 (80.3%) males and 326 (19.7%) females', 'advanced oesophagogastric cancer', 'oesophagogastric cancer', 'patients with advanced oesophagogastric cancer', 'female patients experiencing grade ≥III']",[],"['proportion of gastric tumours', 'gastrointestinal toxicity', 'toxicities including nausea and vomiting, diarrhoea, stomatitis and alopecia', 'serious adverse events', 'chemotherapy efficacy and toxicity']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",[],"[{'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]",1654.0,0.125896,gastrointestinal toxicity was greater (adjusted odds ratio = 1.50; 95% confidence interval = 1.07-2.12).,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Gastrointestinal Research Unit, Royal Marsden Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Anna Dorothea', 'Initials': 'AD', 'LastName': 'Wagner', 'Affiliation': 'Department of Medical Oncology, Centre Hospitalier Universitaire Vaudois, Switzerland.'}, {'ForeName': 'Kyriakos', 'Initials': 'K', 'LastName': 'Kouvelakis', 'Affiliation': 'Gastrointestinal Research Unit, Royal Marsden Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Nanji', 'Affiliation': 'Gastrointestinal Research Unit, Royal Marsden Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Naureen', 'Initials': 'N', 'LastName': 'Starling', 'Affiliation': 'Gastrointestinal Research Unit, Royal Marsden Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Chau', 'Affiliation': 'Gastrointestinal Research Unit, Royal Marsden Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Watkins', 'Affiliation': 'Gastrointestinal Research Unit, Royal Marsden Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Sheela', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Gastrointestinal Research Unit, Royal Marsden Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Peckitt', 'Affiliation': 'Gastrointestinal Research Unit, Royal Marsden Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Gastrointestinal Research Unit, Royal Marsden Hospitals NHS Foundation Trust, London, UK. Electronic address: david.cunningham@rmh.nhs.uk.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.08.010']
1446,29386413,"Effect of Vitamin D therapy on urinary albumin excretion, renal functions, and plasma renin among patients with diabetic nephropathy: A randomized, double-blind clinical trial.","BACKGROUND


Despite different management strategies, progression of proteinuria occurs in a sizable category of patients with diabetic nephropathy (DN). Increase in serum renin levels induced by the renin-angiotensin system (RAS) may contribute to this. Vitamin D therapy is found to have an inhibitory effect on the RAS. We aimed to study the effects of Vitamin D therapy on renal functions of patients with DN.
METHODS


This was a double-blind, randomized, placebo-controlled study. Patients with DN (urinary albumin [UA] >30 mg/g of creatinine) whose estimated glomerular filtration rate (eGFR) was more than 30 mL/min were selected and their plasma renin, parathyroid hormone, serum Vitamin D, serum calcium, serum creatinine, fasting blood sugar were done as baseline measurements. Subjects were randomized into two groups and treatment group was given Vitamin D, 50000 IU (0.25 ml) intramuscularly (IM) monthly for 6 months; control group received distilled water IM. Investigations were repeated after 6 months of therapy.
RESULTS


Of 155 patients invited, 85 were randomly assigned to two groups. After 6 months, mean reduction of UA to creatinine ratio in the treatment and control group was 51.8 mg/g (95% confidence interval [CI]; 66.1--37.5, P ≤ 0.001); 22.4 mg/g (95% CI; -45.7-0.8, P = 0.06), respectively (between group difference P = 0.001). Significant increase in the eGFR observed in the treatment group while eGFR remained unchanged in the control group (P = 0.03 for the between-group difference). Mean reduction in plasma renin in treatment group and control group was 5.85 pg/mL (95% CI; -6.7--4.6) (P < 0.001) and 0.95 pg/mL (95% CI; -1.4--0.14, P = 0.02), respectively.
CONCLUSIONS


Vitamin D 50000 IU given IM monthly for 6 months reduces urine albumin, serum creatinine, and renin levels in patients with DN.",2018,Significant increase in the eGFR observed in the treatment group while eGFR remained unchanged in the control group (P = 0.03 for the between-group difference).,"['Patients with DN (urinary albumin [UA] >30 mg/g of creatinine', 'patients with diabetic nephropathy', '155 patients invited, 85', 'patients with diabetic nephropathy (DN', 'patients with DN']","['Vitamin D 50000 IU', 'placebo', 'Vitamin D', 'Vitamin D therapy', 'distilled water IM']","['mean reduction of UA to creatinine ratio', 'urine albumin, serum creatinine, and renin levels', 'Mean reduction in plasma renin', 'glomerular filtration rate (eGFR', 'serum renin levels', 'eGFR', 'urinary albumin excretion, renal functions, and plasma renin', 'renal functions', 'plasma renin, parathyroid hormone, serum Vitamin D, serum calcium, serum creatinine, fasting blood sugar']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4319613', 'cui_str': '50000'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",85.0,0.531074,Significant increase in the eGFR observed in the treatment group while eGFR remained unchanged in the control group (P = 0.03 for the between-group difference).,"[{'ForeName': 'Plgc', 'Initials': 'P', 'LastName': 'Liyanage', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, University of Ruhuna, Galle, Sri Lanka.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lekamwasam', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Ruhuna, Galle, Sri Lanka.'}, {'ForeName': 'T P', 'Initials': 'TP', 'LastName': 'Weerarathna', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Ruhuna, Galle, Sri Lanka.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Liyanage', 'Affiliation': 'Department of Nuclear Medicine Unit, Faculty of Medicine, University of Ruhuna, Galle, Sri Lanka.'}]",Journal of postgraduate medicine,['10.4103/jpgm.JPGM_598_16']
1447,32411263,Moderate Aerobic Exercise Enhances the Th1/Th2 Ratio in Women with Asthma.,"Background


In this study, we aimed to investigate the effects of aerobic exercise training on the serum IL-4/IFN-γ ratio (Th1/Th2 balance), testosterone/cortisol ratio, levels of cortisol, testosterone, estrogen, and progesterone, and body mass index (BMI) and to determine the relationship between changes in these variables in women with asthma.
Materials and Methods


Twenty-one women with mild to moderate asthma and regular menstrual cycles were selected in this study. Eleven women in the exercise group participated in the aerobic exercise program (60 min/day, three days a week in the evening). Peripheral blood samples were collected before (week 0) and after (week 12) the program. The samples were analyzed to determine the levels of sex hormones and cortisol via chemiluminescence assay, and cytokines were examined by ELISA assay.
Results


The findings showed a significant increase in the Th1/Th2 ratio and a decrease in cortisol and BMI in the exercise group, compared to the control group (P<0.05). There was no significant correlation between changes in cortisol, sex hormones, and BMI and the increase in Th1/Th2 ratio.
Conclusion


The present results suggested that moderate aerobic exercise enhances the Th1/Th2 ratio, independent of changes in steroid hormone level and BMI in women with asthma.",2019,"The present results suggested that moderate aerobic exercise enhances the Th1/Th2 ratio, independent of changes in steroid hormone level and BMI in women with asthma.","['Women with Asthma', 'Eleven women in the exercise group participated in the', 'women with asthma', 'Materials and Methods\n\n\nTwenty-one women with mild to moderate asthma and regular menstrual cycles']","['aerobic exercise program', 'Moderate Aerobic Exercise', 'moderate aerobic exercise', 'aerobic exercise training']","['Th1/Th2 Ratio', 'IL-4/IFN-γ ratio (Th1/Th2 balance), testosterone/cortisol ratio, levels of cortisol, testosterone, estrogen, and progesterone, and body mass index (BMI', 'cortisol, sex hormones, and BMI and the increase in Th1/Th2 ratio', 'cortisol and BMI', 'Th1/Th2 ratio', 'Peripheral blood samples', 'levels of sex hormones and cortisol via chemiluminescence assay, and cytokines']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0201709', 'cui_str': 'Chemiluminescence assay'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",21.0,0.0202045,"The present results suggested that moderate aerobic exercise enhances the Th1/Th2 ratio, independent of changes in steroid hormone level and BMI in women with asthma.","[{'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Zarneshan', 'Affiliation': 'Department of Exercise Physiology, Azarbaijan Shahid Madani University, Tabriz, Iran.'}, {'ForeName': 'Mahdia', 'Initials': 'M', 'LastName': 'Gholamnejad', 'Affiliation': 'Department of Pulmonology, Urmia University of Medical Sciences, Urmia, Iran.'}]",Tanaffos,[]
1448,31629030,"18-month clinical evaluation of a copper-containing universal adhesive in non-carious cervical lesions: A double-blind, randomized controlled trial.","OBJECTIVE


This study aimed to evaluate the addition of copper nanoparticles (CuNp) on the clinical performance of a universal adhesive system used as etch-and-rinse (ER) and self-etch (SE).
METHODS


216 restorations were randomly placed in 36 subjects according to the following groups: ERcu = etch-and-rinse with 0.1% CuNp; ERct = etch-and-rinse without CuNp; SEcu = self-etch with 0.1% CuNp; SEct = self-etch without CuNp. Resin composite was placed incrementally and light-cured. The restorations were evaluated at baseline and 6, 12 and 18 months using the FDI and USPHS criteria. Statistical analyses were performed using appropriate tests (α = 0.05).
RESULTS


The addition of CuNp did not increase the clinical performance (FDI / USPHS) of the universal adhesive tested after 18-month when applied in the ER mode (p > 0.05). The addition of CuNp in SE restorations increased the retention rate significantly and decreased the marginal discrepancies after 18 months (p < 0.05).
CONCLUSION


The clinical performance of universal adhesive was significantly increased when applied in the SE mode with the addition of copper nanoparticles.
CLINICAL RELEVANCE


This is the first study that demonstrates a slight improvement in the clinical performance of universal adhesive systems in non-carious cervical lesions when added CuNp in lower concentration.",2019,The addition of CuNp did not increase the clinical performance (FDI / USPHS) of the universal adhesive tested after 18-month when applied in the ER mode (p > 0.05).,"['non-carious cervical lesions', '216 restorations were randomly placed in 36 subjects according to the following groups']","['etch-and-rinse (ER) and self-etch (SE', 'ERcu = etch-and-rinse with 0.1% CuNp; ERct = etch-and-rinse without CuNp; SEcu = self-etch with 0.1% CuNp; SEct = self-etch without CuNp. Resin composite was placed incrementally and light-cured', 'copper nanoparticles (CuNp', 'copper-containing universal adhesive']","['retention rate', 'clinical performance of universal adhesive', 'clinical performance (FDI / USPHS', 'marginal discrepancies']","[{'cui': 'C4274086', 'cui_str': 'Non carious lesion at cervical margin of tooth (finding)'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0373587', 'cui_str': 'Copper measurement (procedure)'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}]",36.0,0.110542,The addition of CuNp did not increase the clinical performance (FDI / USPHS) of the universal adhesive tested after 18-month when applied in the ER mode (p > 0.05).,"[{'ForeName': 'Thalita P', 'Initials': 'TP', 'LastName': 'Matos', 'Affiliation': 'School of Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil.'}, {'ForeName': 'Mario F', 'Initials': 'MF', 'LastName': 'Gutiérrez', 'Affiliation': 'School of Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil; Institute for Research in Dental Sciences, Faculty of Dentistry, University of Chile, Santiago, Chile; Faculty of Dentistry, Finis Terrae University, Santiago, Chile.'}, {'ForeName': 'Taise A', 'Initials': 'TA', 'LastName': 'Hanzen', 'Affiliation': 'School of Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil.'}, {'ForeName': 'Pâmela', 'Initials': 'P', 'LastName': 'Malaquias', 'Affiliation': 'School of Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'de Paula', 'Affiliation': 'School of Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil.'}, {'ForeName': 'Jullian J', 'Initials': 'JJ', 'LastName': 'de Souza', 'Affiliation': 'School of Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Hass', 'Affiliation': 'Postgraduate Program in Dentistry, University of Northern Parana, Londrina, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Fernández', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, University of Chile, Santiago, Chile; Instituto de Ciencias Biomédicas, Universidad Autónoma de Chile, Providencia, Chile.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Reis', 'Affiliation': 'Department of Restorative Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil.'}, {'ForeName': 'Alessandro D', 'Initials': 'AD', 'LastName': 'Loguercio', 'Affiliation': 'Department of Restorative Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil. Electronic address: aloguercio@hotmail.com.'}]",Journal of dentistry,['10.1016/j.jdent.2019.103219']
1449,31627057,Management of non-severe pregnancy hypertension - A summary of the CHIPS Trial (Control of Hypertension in Pregnancy Study) research publications.,"The international CHIPS Trial (Control of Hypertension In Pregnancy Study) enrolled 987 women with chronic (75%) or gestational (25%) hypertension. Pre-eclampsia developed in 48%; women remained on their allocated BP control and delivered an average of two weeks later. 'Less tight' control (target diastolic BP 100 mmHg) achieved BP that was 6/5mmHg higher (p < 0.001) than 'tight' control (target diastolic 85 mmHg, BP achieved 133/85 mmHg). 'Less tight' (vs. 'tight') control resulted in similar adverse perinatal outcomes (31.5% vs. 30.7%; p = 0.84) that balanced birthweight < 10th percentile (16.1% vs. 19.8%; p = 0.14) against preterm birth (35.6% vs. 31.5%; p = 0.18). 12-month follow-up revealed no compelling evidence for developmental programming of child growth. However, 'less tight' (vs. 'tight') control resulted in more severe maternal hypertension (40.6% vs. 27.5%; p < 0.001), and more women with platelets < 100 × 10 9 /L (4.3% vs. 1.6%; p = 0.02) or symptomatic elevated liver enzymes (4.3% vs. 1.8%; p = 0.03), with no difference in serious maternal complications (3.7% vs. 2.0%; p = 0.17). Labetalol was the drug of choice. Methyldopa did not result in inferior outcomes. Post-hoc, severe hypertension, independent of pre-eclampsia, was associated with heightened increased risk of adverse outcomes, and in 'less tight' control, of serious maternal complications. At no gestational age at initiation of BP control was 'less tight' superior to 'tight'. Women in both groups were equally satisfied with care. 'Less tight' control tended to be more expensive by CAD$6000 (p =0.07) based on neonatal care costs. Collectively, CHIPS publications have provided evidence that women with non-severe pregnancy hypertension should receive 'tight' BP control achieved by a simple algorithm.",2019,Less tight' control tended to be more expensive by CAD$6000 (p =0.07) based on neonatal care costs.,"['987 women with chronic (75%) or gestational (25%) hypertension', 'women with non-severe pregnancy hypertension']","['Labetalol', 'Methyldopa']","['preterm birth', ""risk of adverse outcomes, and in 'less tight' control, of serious maternal complications"", 'serious maternal complications', 'BP', 'severe maternal hypertension', 'eclampsia', 'diastolic BP', 'symptomatic elevated liver enzymes', 'neonatal care costs', 'severe hypertension', 'adverse perinatal outcomes']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0022860', 'cui_str': 'Labetalol'}, {'cui': 'C3652552', 'cui_str': 'methyldopa (racemic)'}]","[{'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0453911', 'cui_str': 'Tights (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0565599', 'cui_str': 'Maternal hypertension (disorder)'}, {'cui': 'C0013537', 'cui_str': 'Eclampsia'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0235996', 'cui_str': 'Hepatic enzyme increased'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",987.0,0.15639,Less tight' control tended to be more expensive by CAD$6000 (p =0.07) based on neonatal care costs.,"[{'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Women and Children's Health, King's College London, UK. Electronic address: Laura.A.Magee@kcl.ac.uk.""}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Rey', 'Affiliation': 'Departments of Medicine and Obstetrics and Gynaecology, Université de Montreal, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Asztalos', 'Affiliation': 'Department of Pediatrics, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Hutton', 'Affiliation': 'McMaster University, Hamilton, Canada.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': 'School of Population and Public Health, Centre for Health Evaluation and Outcome Science, Providence Health Care Research Institute, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Helewa', 'Affiliation': 'University of Manitoba, Canada.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Centre for Health Evaluation and Outcome Science, Providence Health Care Research Institute, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Logan', 'Affiliation': 'Department of Medicine, University of Toronto, Canada.'}, {'ForeName': 'Wessel', 'Initials': 'W', 'LastName': 'Ganzevoort', 'Affiliation': 'Department of Obstetrics, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Welch', 'Affiliation': 'University Hospitals Plymouth NHS Trust, UK.'}, {'ForeName': 'Jim G', 'Initials': 'JG', 'LastName': 'Thornton', 'Affiliation': 'Division of Child Health, Obstetrics & Gynaecology, School of Medicine, University of Nottingham, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Women and Children's Health, King's College London, UK.""}]",Pregnancy hypertension,['10.1016/j.preghy.2019.08.166']
1450,32411551,"Impact of Simulation Training on Undergraduate Clinical Decision-making in Emergencies: A Non-blinded, Single-centre, Randomised Pilot Study.","Introduction There is an increasing evidence base for the use of simulation-based medical education. Simulation is superior to more didactic methods for teaching a range of technical and non-technical skills, and students report they often derive more educational value from it compared with other teaching methods. There is currently limited evidence that simulation training improves clinical decision-making and, therefore, this pilot study sought to explore this further. Methods Students were randomised to take part in either five classroom tutorials and simulation training sessions or five classroom tutorials and an online e-learning module. On completion of the teaching, students all undertook an unseen assessment scenario (managing a simulated patient with anaphylaxis), where they were scored using a weighted marking scheme. The time taken to make decisions and student-reported confidence in decisions were also measured. Results 14/14 simulation-group participants and 12/14 e-learning-group participants completed the post-learning assessment. The simulation group identified anaphylaxis and gave adrenaline more quickly (p 0.008 and 0.005, respectively), and this cohort was more confident in making the diagnosis (p 0.044). There was no statistically significant difference between weighted global assessment scores for each group (p 0.705). The e-learning group called for help more quickly (p.0.049), although fewer students in this group called for help (five vs. nine). There was no statistical difference in confidence in decisions to administer adrenaline or call for help (p 0.539 and 0.364 respectively). Conclusions Participants who undertook simulation training were able to more confidently and quickly identify the diagnosis and initiate emergency treatment. However, there was not a statistically significant difference between groups using an overall weighted score. Using simulation to train students to perform better in emergencies and improve their decision-making shows promise but a further quantitative study is required.",2020,Conclusions Participants who undertook simulation training were able to more confidently and quickly identify the diagnosis and initiate emergency treatment.,['Undergraduate Clinical Decision-making in Emergencies'],"['adrenaline', 'Simulation Training', 'five classroom tutorials and simulation training sessions\xa0or five classroom tutorials and an online e-learning module']",['weighted global assessment scores'],"[{'cui': 'C4042877', 'cui_str': 'Medical Decision-Making'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3542953', 'cui_str': 'Module'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}]",,0.0581088,Conclusions Participants who undertook simulation training were able to more confidently and quickly identify the diagnosis and initiate emergency treatment.,"[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Everson', 'Affiliation': 'Emergency Medicine, School of Medicine, Anglia Ruskin University and Southend University Hospital, Chelmsford, GBR.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Gao', 'Affiliation': 'Emergency Medicine, School of Medicine, Anglia Ruskin University, Chelmsford, GBR.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Roder', 'Affiliation': 'Medical Education and Simulation, School of Medicine, Anglia Ruskin University, Chelmsford, GBR.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kinnear', 'Affiliation': 'Internal Medicine: Critical Care, School of Medicine, Anglia Ruskin University, Chelmsford, GBR.'}]",Cureus,['10.7759/cureus.7650']
1451,31628272,Relationship Between Pain Catastrophizing and 6-Month Outcomes Following Anterior Cruciate Ligament Reconstruction.,"BACKGROUND


Pain catastrophizing predicts poor outcomes following orthopedic procedures for patients with chronic conditions; however, limited research has focused on acute injuries. This study aimed to quantify the progression of Pain Catastrophizing Scale (PCS) scores from injury to 6-months post-anterior cruciate ligament reconstruction (ACLR) and determine if preoperative or 6-month PCS scores were related with self-reported pain or function 6 months post-ACLR. The authors hypothesized PCS scores would minimally fluctuate and would be related with worse outcomes 6-months post-ACLR.
METHODS


All 48 participants (27 male/21 female; aged 22.7 [4.6] y, body mass index 24 [3.3]) included in this secondary analysis of a randomized control trial sustained an ACL injury during sports activity. Participants completed the PCS and Pain Visual Analog Scale (VAS) at 5 time points: within 7 days of injury (INITIAL), day of surgery, 2 weeks postoperative (2W), 6 weeks postoperative (6W), and 6 months postoperative (6M). They completed the Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6M. Wilcoxon signed-rank tests and Spearman rank-order correlations were used for analysis.
RESULTS


PCS scores were not fixed (INITIAL: 11.6 [10.8], day of surgery: 2.5 [3.7], 2W: 8.0 [7.8], 6W: 3.7 [6], 6M: 0.8 [2.3]). They fluctuated in response to injury and ACLR similar to Pain VAS scores. Preoperative PCS scores were not related with 6M outcomes; however, 6M PCS scores were significantly related with 6M Pain VAS and KOOS subscales.
CONCLUSIONS


PCS scores fluctuated in response to injury and ACLR. Preoperative PCS scores were not related with 6M outcomes; however, 6M PCS scores correlated with pain and function at 6M. High pain catastrophizing appears to be a natural response immediately following acute ACL injury and ACLR, but may not be indicative of a poor postoperative result. PCS scores 6-months following ACLR may provide useful information regarding self-reported pain and function.",2019,"Preoperative PCS scores were not related with 6M outcomes; however, 6M PCS scores were significantly related with 6M Pain VAS and KOOS subscales.
","['patients with chronic conditions', 'All 48 participants (27 male/21 female; aged 22.7 [4.6] y, body mass index 24 [3.3']","['anterior cruciate ligament reconstruction (ACLR', 'Anterior Cruciate Ligament Reconstruction']","['Pain VAS scores', 'progression of Pain Catastrophizing Scale (PCS) scores', 'Preoperative PCS scores', 'Knee Injury and Osteoarthritis Outcome Score (KOOS', '6M Pain VAS and KOOS subscales', '6M PCS scores', 'PCS and Pain Visual Analog Scale (VAS', 'PCS scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517764', 'cui_str': 'Four point six'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}]","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",48.0,0.0668153,"Preoperative PCS scores were not related with 6M outcomes; however, 6M PCS scores were significantly related with 6M Pain VAS and KOOS subscales.
","[{'ForeName': 'Kate N', 'Initials': 'KN', 'LastName': 'Jochimsen', 'Affiliation': ''}, {'ForeName': 'Margaret R', 'Initials': 'MR', 'LastName': 'Pelton', 'Affiliation': ''}, {'ForeName': 'Carl G', 'Initials': 'CG', 'LastName': 'Mattacola', 'Affiliation': ''}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Huston', 'Affiliation': ''}, {'ForeName': 'Emily K', 'Initials': 'EK', 'LastName': 'Reinke', 'Affiliation': ''}, {'ForeName': 'Kurt P', 'Initials': 'KP', 'LastName': 'Spindler', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lattermann', 'Affiliation': ''}, {'ForeName': 'Cale A', 'Initials': 'CA', 'LastName': 'Jacobs', 'Affiliation': ''}]",Journal of sport rehabilitation,['10.1123/jsr.2018-0431']
1452,31523057,Understanding of prognosis in non-metastatic prostate cancer: a randomised comparative study of clinician estimates measured against the PREDICT prostate prognostic model.,"PREDICT Prostate is an individualised prognostic model that provides long-term survival estimates for men diagnosed with non-metastatic prostate cancer ( www.prostate.predict.nhs.uk ). In this study clinician estimates of survival were compared against model predictions and its potential value as a clinical tool was assessed. Prostate cancer (PCa) specialists were invited to participate in the study. 190 clinicians (63% urologists, 17% oncologists, 20% other) were randomised into two groups and shown 12 clinical vignettes through an online portal. Each group viewed opposing vignettes with clinical information alone, or alongside PREDICT Prostate estimates. 15-year clinician survival estimates were compared against model predictions and reported treatment recommendations with and without seeing PREDICT estimates were compared. 155 respondents (81.6%) reported counselling new PCa patients at least weekly. Clinician estimates of PCa-specific mortality exceeded PREDICT estimates in 10/12 vignettes. Their estimates for treatment survival benefit at 15 years were over-optimistic in every vignette, with mean clinician estimates more than 5-fold higher than PREDICT Prostate estimates. Concomitantly seeing PREDICT Prostate estimates led to significantly lower reported likelihoods of recommending radical treatment in 7/12 (58%) vignettes, particularly in older patients. These data suggest clinicians overestimate cancer-related mortality and radical treatment benefit. Using an individualised prognostic tool may help reduce overtreatment.",2019,PREDICT Prostate is an individualised prognostic model that provides long-term survival estimates for men diagnosed with non-metastatic prostate cancer ( www.prostate.predict.nhs.uk ).,"['non-metastatic prostate cancer', 'Prostate cancer (PCa) specialists', 'men diagnosed with non-metastatic prostate cancer ( www.prostate.predict.nhs.uk ', '190 clinicians (63% urologists, 17% oncologists, 20% other']",[],"['PCa-specific mortality', '15-year clinician survival estimates']","[{'cui': 'C1282496', 'cui_str': 'Metastasis from malignant tumor of prostate'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0260314', 'cui_str': 'Urologists'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}]",[],"[{'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",,0.0282638,PREDICT Prostate is an individualised prognostic model that provides long-term survival estimates for men diagnosed with non-metastatic prostate cancer ( www.prostate.predict.nhs.uk ).,"[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Thurtle', 'Affiliation': 'Academic Urology Group, University of Cambridge, Cambridge, UK. dt433@cam.ac.uk.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Jenkins', 'Affiliation': 'Sussex Health Outcomes Research & Education in Cancer, University of Sussex, Brighton, UK.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Pharoah', 'Affiliation': 'Centre for Cancer Genetic Epidemiology, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Gnanapragasam', 'Affiliation': 'Academic Urology Group, University of Cambridge, Cambridge, UK.'}]",British journal of cancer,['10.1038/s41416-019-0569-4']
1453,32411301,Angiographic Restenosis in Coronary Bifurcations Treatment with Regular Drug Eluting Stents and Dedicated Bifurcation Drug-Eluting BiOSS Stents: Analysis Based on Randomized POLBOS I and POLBOS II Studies.,"Aim


The marked variation in bifurcation anatomy has brought about an ongoing search for stents specifically constructed for coronary bifurcations. This study aimed to analyze the angiographic restenosis prevalence and patterns and predictors of different patterns in dedicated bifurcation BiOSS® vs. current generation drug-eluting stents implanted in coronary bifurcation lesions based on data from two clinical trials POLBOS I and II.
Methods


Dedicated bifurcation BiOSS® stents were compared with drug-eluting stents (DES) in patients with stable coronary artery disease (CAD) or nonST elevation acute coronary syndrome (NSTE-ACS) (POLBOS I: paclitaxel eluting BiOSS® Expert vs. DES; POLBOS II: sirolimus eluting BiOSS® LIM vs. DES). Provisional T-stenting was the default treatment. Morphological pattern of in-stent restenosis according to the modified Mehran classification adopted for bifurcation lesions was assessed with bifurcation dedicated quantitative coronary angiographic software (CAAS 5.11, Pie Medical Imaging BV, the Netherlands).
Results


In total, 445 patients (222 patients in BiOSS group and 223 patients in DES group) were included into the analysis. In BiOSS group 24 cases of angiographic restenosis (10.8%) were recorded, and in DES group-17 cases (7.6%) at 12 months follow-up (angiographic control rate at follow-up-90.3%). In the BiOSS group most frequent medina classification in restenotic cases was 0.0.1 (25%), whereas in DES-0.0.1 and 0.1.1 (23.5% each). In multivariate regression analysis proximal optimization technique was associated with the lowest chance for restenosis (OR 0.15, 95% CI 0.06-0.33), whereas diabetes on insulin was associated with the highest risk of restenosis (OR 4.21, 95% CI 1.48-11.44).
Conclusions


The angiographic restenosis pattern and rate was similar between BiOSS stents and DES in coronary bifurcation lesions.",2020,"In multivariate regression analysis proximal optimization technique was associated with the lowest chance for restenosis (OR 0.15, 95% CI 0.06-0.33), whereas diabetes on insulin was associated with the highest risk of restenosis (OR 4.21, 95% CI 1.48-11.44).
","['445 patients (222 patients in BiOSS group and 223 patients in DES group) were included into the analysis', 'patients with stable coronary artery disease (CAD) or nonST elevation acute coronary syndrome (NSTE-ACS']","['Provisional T-stenting', 'drug-eluting stents (DES', '® stents', 'Regular Drug Eluting Stents and Dedicated Bifurcation Drug-Eluting BiOSS Stents']","['angiographic restenosis', 'angiographic restenosis pattern and rate', 'highest risk of restenosis', 'Angiographic Restenosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]",445.0,0.027815,"In multivariate regression analysis proximal optimization technique was associated with the lowest chance for restenosis (OR 0.15, 95% CI 0.06-0.33), whereas diabetes on insulin was associated with the highest risk of restenosis (OR 4.21, 95% CI 1.48-11.44).
","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gil', 'Affiliation': 'Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Bil', 'Affiliation': 'Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kern', 'Affiliation': 'Department of Cardiology and Cardiosurgery, University of Varmia and Masuria, Olsztyn, Poland.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Iñigo-Garcia', 'Affiliation': 'Costa del Sol Hospital, Marbella, Spain.'}, {'ForeName': 'Radoslaw', 'Initials': 'R', 'LastName': 'Formuszewicz', 'Affiliation': '10 Clinical Military Hospital, Bydgoszcz, Poland.'}, {'ForeName': 'Slawomir', 'Initials': 'S', 'LastName': 'Dobrzycki', 'Affiliation': 'Department of Invasive Cardiology, Medical University in Bialystok, Bialystok, Poland.'}, {'ForeName': 'Dobrin', 'Initials': 'D', 'LastName': 'Vassilev', 'Affiliation': 'Alexandrovska University Hospital, Sofia, Bulgaria.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",Cardiovascular therapeutics,['10.1155/2020/6760205']
1454,32411460,Laparoscopic Suture versus Mesh Rectopexy for the Treatment of Persistent Complete Rectal Prolapse in Children: A Comparative Randomized Study.,"Purpose


To compare laparoscopic mesh rectopexy with laparoscopic suture rectopexy.  Patients and Methods . The prospective study was conducted at Pediatric Surgery Department, Al-Azhar University Hospitals, Cairo, Egypt between Feb 2010 and Jan 2015. Seventy-eight children with persistent complete rectal prolapse were subjected to laparoscopic rectopexy. Fourteen parents refused to participate. All patients received initial conservative treatment for more than one year. The remaining 64 patients were randomized divided into two equal groups. Group A; 32 patients underwent laparoscopic mesh rectopexy and group B, 32 underwent laparoscopic suture rectopexy. The operative time, recurrence rate, post-operative constipation, and effect on fecal incontinence, were reported and evaluated for each group.
Results


Sixty-four cases presented with persistent complete rectal prolapse were the material of this study. They were 40 males and 24 females. Mean age at operation was 8 (5-12) years. All cases were completed laparoscopically. Mean operative time in laparoscopic suture rectopexy was shorter than laparoscopic mesh rectopexy group. No early post-operative complications were encountered. No cases of recurrence with mesh rectopexy group while in suture rectopexy group it was 4 cases (14.2%). Post-operative constipation occurred in one case (3.57%) in suture rectopexy group and occurred in one case (3.3%) in mesh rectopexy group. Fecal incontinence improved in 26/28 cases (92.8%) in suture rectopexy while in mesh rectopexy it was improved in 30/30 cases (100%) of cases.
Conclusion


Both laparoscopic mesh and suture rectopexy are feasible and reliable methods for the treatment of complete rectal prolapse in children. However, no recurrence, low incidence of constipation and high improvement of incontinence at follow up more than 36 months with mesh rectopexy accordingly, we considered mesh rectopexy to be the procedure of choice in treatment of complete rectal prolapse.",2020,Both laparoscopic mesh and suture rectopexy are feasible and reliable methods for the treatment of complete rectal prolapse in children.,"['They were 40 males and 24 females', 'complete rectal prolapse in children', '64 patients', 'Persistent Complete Rectal Prolapse in Children', 'Fourteen parents refused to participate', 'Seventy-eight children with persistent complete rectal prolapse', 'Pediatric Surgery Department, Al-Azhar University Hospitals, Cairo, Egypt between Feb 2010 and Jan 2015']","['laparoscopic suture rectopexy', 'laparoscopic mesh rectopexy', 'laparoscopic mesh and suture rectopexy', 'laparoscopic rectopexy', 'initial conservative treatment', 'Laparoscopic Suture versus Mesh Rectopexy']","['persistent complete rectal prolapse', 'Mean operative time', 'no recurrence, low incidence of constipation and high improvement of incontinence', 'Post-operative constipation', 'operative time, recurrence rate, post-operative constipation, and effect on fecal incontinence', 'Fecal incontinence']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0341399', 'cui_str': 'Complete rectal prolapse'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0279077', 'cui_str': 'Pediatric surgery'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0193176', 'cui_str': 'Proctopexy'}, {'cui': 'C0400222', 'cui_str': 'Mesh rectopexy'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0341399', 'cui_str': 'Complete rectal prolapse'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",78.0,0.0386761,Both laparoscopic mesh and suture rectopexy are feasible and reliable methods for the treatment of complete rectal prolapse in children.,"[{'ForeName': 'AbdelAziz', 'Initials': 'A', 'LastName': 'Yehya', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Gamaan', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelrazek', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Shahin', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Seddek', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelhafez', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University Hospitals, Cairo, Egypt.'}]",Minimally invasive surgery,['10.1155/2020/3057528']
1455,31625399,Psychosocial impact of inclusion of HPV test on the management of women with atypical squamous cells of undetermined significance: a study within a randomised pragmatic trial in a middle-income country.,"Objective:  To assess the psychosocial impact of human papillomavirus (HPV) testing, colposcopy, and Pap-smear, as triage strategies after a Pap-smear with atypical squamous cells of undetermined significance (ASCUS). We also sought to evaluate the psychosocial impact based on the results of the strategies.  Methods:  Nested within a randomised pragmatic trial, which compared an immediate colposcopy, repeat Pap-smear, and high risk HPV test, we enrolled 675 women between 2012 and 2014. Participants completed surveys at enrollment, two weeks after triage test results, and 1 year thereafter to assess cervical cancer and HPV knowledge, self-esteem, anxiety and HPV impact (HIP).  Results:  Knowledge, self-esteem, anxiety and HIP improved with no differences among arms. At the baseline, 31.4% and 32.7% of the participants had state anxiety and trait anxiety, respectively, which decreased to 10.7% and 13.3% in the last survey. Compared to HPV-negative women, HPV-positive women in the second survey had worse HIP scores (HPV-:  M  22.9 [SD: 15.20]; HPV+:  M  35.9 [SD: 19.91];  p <  0.001), trait anxiety (HPV-:  M  15.4 [SD 12.73]; HPV+:  M  22.9 [SD 13.29];  p  = 0.001), and state anxiety (HPV-:  M  10.7 [SD 11.25]; HPV+:  M  21.4 [SD 14.81];  p <  0.001).  Conclusions : HPV testing as a triage strategy for women with ASCUS does not differ from colposcopies or Pap-smears in terms of psychosocial outcomes.",2020,"Results:  Knowledge, self-esteem, anxiety and HIP improved with no differences among arms.","['women with atypical squamous cells of undetermined significance', 'women with ASCUS', 'enrolled 675 women between 2012 and 2014']","['HPV test', 'human papillomavirus (HPV) testing, colposcopy, and Pap-smear', 'HPV', 'immediate colposcopy, repeat Pap-smear, and high risk HPV test']","['Results:  Knowledge, self-esteem, anxiety and HIP', 'state anxiety and trait anxiety', 'state anxiety', 'trait anxiety', 'HIP scores', 'cervical cancer and HPV knowledge, self-esteem, anxiety and HPV impact (HIP']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0521184', 'cui_str': 'ASCUS'}, {'cui': 'C4517854', 'cui_str': '675 (qualifier value)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0009417', 'cui_str': 'Colposcopy'}, {'cui': 'C0079104', 'cui_str': 'Cervical Smears'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",675.0,0.123197,"Results:  Knowledge, self-esteem, anxiety and HIP improved with no differences among arms.","[{'ForeName': 'Isabel C', 'Initials': 'IC', 'LastName': 'Garcés-Palacio', 'Affiliation': 'Grupo de Epidemiología, Facultad Nacional de Salud Pública, Universidad de Antioquia (UdeA), Medellín, Colombia.'}, {'ForeName': 'Gloria I', 'Initials': 'GI', 'LastName': 'Sanchez', 'Affiliation': 'Grupo Infección y Cáncer, Facultad de Medicina, Universidad de Antioquia (UdeA), Medellín, Colombia.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Baena Zapata', 'Affiliation': 'Grupo Infección y Cáncer, Facultad de Medicina, Universidad de Antioquia (UdeA), Medellín, Colombia.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Córdoba Sánchez', 'Affiliation': 'Grupo Atropos, Universidad de Antioquia (UdeA), Medellín, Colombia.'}, {'ForeName': 'Yenny', 'Initials': 'Y', 'LastName': 'Urrea Cosme', 'Affiliation': 'Grupo Atropos, Universidad de Antioquia (UdeA), Medellín, Colombia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rodríguez Zabala', 'Affiliation': 'Grupo Atropos, Universidad de Antioquia (UdeA), Medellín, Colombia.'}, {'ForeName': 'Mario Alberto', 'Initials': 'MA', 'LastName': 'Ruiz Osorio', 'Affiliation': 'Grupo Atropos, Universidad de Antioquia (UdeA), Medellín, Colombia.'}]",Psychology & health,['10.1080/08870446.2019.1678749']
1456,31621523,"Improving HbA 1c  with Glucose Self-Monitoring in Diabetic Patients with EpxDiabetes, a Phone Call and Text Message-Based Telemedicine Platform: A Randomized Controlled Trial.","Background:   We conducted a randomized controlled trial of EpxDiabetes, a novel digital health intervention as an adjunct therapy to reduce HbA 1c  and fasting blood glucose (FBG) among patients with type 2 diabetes mellitus (T2DM). In addition, we examined the effect of social determinants of health on our system.   Methods:   Sixty-five ( n  = 65) patients were randomized at a primary care clinic. Self-reported FBG data were collected by EpxDiabetes automated phone calls or text messages. Only intervention group responses were shared with providers, facilitating follow-up and bidirectional communication. ΔHbA 1c  and ΔFBG were analyzed after 6 months.   Results:   There was an absolute HbA 1c  reduction of 0.69% in the intervention group (95% confidence interval [CI], -1.41 to 0.02) and an absolute reduction of 0.03% in the control group (95% CI, -0.88 to 0.82). For those with baseline HbA 1c  >8%, HbA 1c  decreased significantly by 1.17% in the intervention group (95% CI, -1.90 to -0.44), and decreased by 0.02% in the control group (95% CI, -0.99 to 0.94). FBG decreased in the intervention group by 21.6 mg/dL (95% CI, -37.56 to -5.639), and increased 13.0 mg/dL in the control group (95% CI, -47.67 to 73.69). Engagement (proportion responding to ≥25% of texts or calls over 4 weeks) was 58% for the intervention group (95% CI, 0.373-0.627) and 48% for the control group (95% CI, 0.296-0.621). Smoking, number of comorbidities, and response rate were significant predictors of ΔHbA 1c .   Conclusions:   EpxDiabetes helps to reduce HbA 1c  in patients with uncontrolled T2DM and fosters patient-provider communication; it has definite merit as an adjunct therapy in diabetes management. Future work will focus on improving the acceptability of the system and implementation on a larger scale trial.",2019,"FBG decreased in the intervention group by 21.6 mg/dL (95% CI, -37.56 to -5.639), and increased 13.0 mg/dL in the control group (95% CI, -47.67 to 73.69).","['Diabetic Patients with EpxDiabetes', 'Methods:   Sixty-five ( n \u2009=\u200965', 'patients with type 2 diabetes mellitus (T2DM']",['novel digital health intervention'],"['FBG', 'HbA 1c  and fasting blood glucose (FBG', 'HbA 1c', 'Smoking, number of comorbidities, and response rate', 'ΔHbA 1c  and ΔFBG']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",,0.0600336,"FBG decreased in the intervention group by 21.6 mg/dL (95% CI, -37.56 to -5.639), and increased 13.0 mg/dL in the control group (95% CI, -47.67 to 73.69).","[{'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Xing', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Kavon', 'Initials': 'K', 'LastName': 'Javaherian', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Peters', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Ross', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Bernal-Mizrachi', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipid Research, Washington University School of Medicine, St. Louis, Missouri.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2019.0035']
1457,29254414,"A Randomized Controlled Trial to Examine the Posttreatment Efficacy of Neurofeedback, Behavior Therapy, and Pharmacology on ADHD Measures.","OBJECTIVE


To examine the efficacy of neurofeedback (NF), behavior therapy (BT), and pharmacology (PH) on the improvement of ADHD-related symptoms.
METHOD


Fifty-nine children with ADHD ( M = 8.80 years, SD = 1.92 years) were randomly assigned to one of the three treatments in a pre/post assessment design. Mother- and teacher-rated ADHD scales and children were assessed using The Integrated Visual and Auditory Continuous Performance Test (IVA/CPT).
RESULTS


The three treatments were effective on the IVA/CPT, but with different trends. BT and especially NF achieved improvement on response control and attention, and PH mainly in visual attention. On the rating scales, BT improved all measures, and NF and PH had a minor but interesting influence.
CONCLUSION


From a global perspective, behavior therapy had the most extensive results, but PH had the greatest capacity to improve overall attention. NF was able to improve both control response and inattention. Clinical implications are discussed.",2019,"On the rating scales, BT improved all measures, and NF and PH had a minor but interesting influence.
","['Fifty-nine children with ADHD ( M = 8.80 years, SD = 1.92 years']","['neurofeedback (NF), behavior therapy (BT), and pharmacology (PH', 'Neurofeedback, Behavior Therapy']","['Integrated Visual and Auditory Continuous Performance Test (IVA/CPT', 'response control and attention, and PH mainly in visual attention', 'overall attention']","[{'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0589102', 'cui_str': 'Visual attention, function (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",59.0,0.0317729,"On the rating scales, BT improved all measures, and NF and PH had a minor but interesting influence.
","[{'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Moreno-García', 'Affiliation': '1 University of Seville, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Meneres-Sancho', 'Affiliation': '1 University of Seville, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Camacho-Vara de Rey', 'Affiliation': '1 University of Seville, Spain.'}, {'ForeName': 'Mateu', 'Initials': 'M', 'LastName': 'Servera', 'Affiliation': '2 University of Balearic Island, Palma, Spain.'}]",Journal of attention disorders,['10.1177/1087054717693371']
1458,32411374,Periodized resistance training for persistent non-specific low back pain: a mixed methods feasibility study.,"Background


We investigated the feasibility of a 16-week supervised heavy resistance training program with weekly undulating periodization for individuals with persistent non-specific low-back pain (LBP).
Methods


Twenty-five adults with persistent non-specific LBP participated in this mixed methods feasibility study. Participants trained a whole-body program consisting of squat, bench press, deadlift and pendlay row two times per week for 16 weeks. We assessed pain intensity, pain-related disability, pain self-efficacy and one-repetition maximum strength at baseline, 8 weeks and 16 weeks. Three focus group interviews were conducted at the end of the program. Linear mixed models were used to assess changes in outcomes, and the qualitative data was assessed using systematic text condensation.
Results


We observed clinically meaningful reductions in pain intensity after 8 and 16 weeks of training. The mean difference on the numeric pain rating scale (0-10) in the last 2 weeks from baseline to 8 weeks was 2.6 (95% CI: 1.8-3.6) and from baseline to 16 weeks 3.4 (95% CI: 2.5-4.4). In addition, there were improvements in pain-related disability (3.9, 95% CI: 2.3-5.5), pain self-efficacy (7.7, 95% CI: 5.4-10.1) and muscle strength. In the focus group interviews, participants talked about challenges regarding technique, the importance of supervision and the advantages of periodizing the training. Perceived benefits were improved pain, daily functioning, energy level and sleep, and changes in views on physical activity.
Conclusion


Periodized resistance training with weekly undulating periodization is a feasible training method for this group of individuals with persistent non-specific LBP. A randomized clinical trial should assess the efficacy of such an intervention.
Trial registration


clinicaltrials.gov   /  Identifier - NCT04284982, Registered on February 24th 2020.",2020,"In addition, there were improvements in pain-related disability (3.9, 95% CI: 2.3-5.5), pain self-efficacy (7.7, 95% CI: 5.4-10.1) and muscle strength.","['Methods\n\n\nTwenty-five adults with persistent non-specific LBP', 'individuals with persistent non-specific LBP', 'persistent non-specific low back pain', 'individuals with persistent non-specific low-back pain (LBP']","['Periodized resistance training', 'supervised heavy resistance training program']","['muscle strength', 'pain intensity', 'pain self-efficacy', 'pain, daily functioning, energy level and sleep, and changes in views on physical activity', 'pain intensity, pain-related disability, pain self-efficacy and one-repetition maximum strength', 'numeric pain rating scale', 'pain-related disability']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",25.0,0.159802,"In addition, there were improvements in pain-related disability (3.9, 95% CI: 2.3-5.5), pain self-efficacy (7.7, 95% CI: 5.4-10.1) and muscle strength.","[{'ForeName': 'Svein O', 'Initials': 'SO', 'LastName': 'Tjøsvoll', 'Affiliation': '1Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Mork', 'Affiliation': '2Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Vegard M', 'Initials': 'VM', 'LastName': 'Iversen', 'Affiliation': '2Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Marit B', 'Initials': 'MB', 'LastName': 'Rise', 'Affiliation': '3Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Marius S', 'Initials': 'MS', 'LastName': 'Fimland', 'Affiliation': '1Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-020-00181-0']
1459,32411517,Evaluating the stress-response of dental students to the dental school environment.,"Introduction and Objective


Dentists experience high amounts of professional stress beginning with their student years in dental school. This stress, given its early onset, may negatively impact the personal and professional lives of these individuals, as well as the quality of their clinical work. We sought to create an objective scale to evaluate the levels of stress in students at different stages of their education, as well as in practicing physicians.
Materials and Methods


Thirty dental students participated in this study, with 10 students each selected from junior, mid-senior, and senior classes. They were randomly divided into two groups in which one group was subjected to stressors while the other group was not. JINS MEME ES_R (JINS) smart glasses and Garmin Vivoactive 3 smartwatches were used to obtain data, including electrooculography (EOG), heart rate (HR), and accelerometer (ACC) and gyroscope (GYRO) feedback, while the subjects performed a dental exercise on a phantom tooth.
Results


The heart rates of more experienced students were lower than those of the junior students. The EOG, ACC, and GYRO signals showed multiple differences in the measurement of amplitudes and frequency of episodes.
Conclusion


Our pilot results show that electronic tools, like smart glasses with software and sensors, are useful for monitoring the stress levels of dental students in preclinical operating conditions. We would like to further assess the stress levels in students performing dental procedures on phantom teeth and in later clinical interactions with patients.",2020,"Our pilot results show that electronic tools, like smart glasses with software and sensors, are useful for monitoring the stress levels of dental students in preclinical operating conditions.","['students at different stages of their education, as well as in practicing physicians', 'dental students to the dental school environment', 'professional stress beginning with their student years in dental school', 'students performing dental procedures on phantom teeth and in later clinical interactions with patients', 'Thirty dental students participated in this study, with 10 students each selected from junior, mid-senior, and senior classes']",[],"['electrooculography (EOG), heart rate (HR), and accelerometer (ACC) and gyroscope (GYRO) feedback', 'heart rates', 'amplitudes and frequency of episodes']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0036376', 'cui_str': 'Dental School'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C0282611', 'cui_str': 'Phantom'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0456387', 'cui_str': 'Class'}]",[],"[{'cui': 'C0013854', 'cui_str': 'Electro-oculogram examination'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",30.0,0.0162069,"Our pilot results show that electronic tools, like smart glasses with software and sensors, are useful for monitoring the stress levels of dental students in preclinical operating conditions.","[{'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Mocny-Pachońska', 'Affiliation': 'Department of Conservative Dentistry with Endodontics, Medical University of Silesia, Faculty of Medical Science, Bytom, Poland.'}, {'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Doniec', 'Affiliation': 'Faculty of Biomedical Engineering, Department of Biosensors and Biomedical Signal Processing, Silesian University of Technology, Zabrze, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Trzcionka', 'Affiliation': 'Department of Conservative Dentistry with Endodontics, Medical University of Silesia, Faculty of Medical Science, Bytom, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Pachoński', 'Affiliation': 'Pachonscy Dental Clinic, Strzebiń, Poland.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Piaseczna', 'Affiliation': 'Faculty of Biomedical Engineering, Department of Biosensors and Biomedical Signal Processing, Silesian University of Technology, Zabrze, Poland.'}, {'ForeName': 'Szymon', 'Initials': 'S', 'LastName': 'Sieciński', 'Affiliation': 'Faculty of Biomedical Engineering, Department of Biosensors and Biomedical Signal Processing, Silesian University of Technology, Zabrze, Poland.'}, {'ForeName': 'Oleksandra', 'Initials': 'O', 'LastName': 'Osadcha', 'Affiliation': 'Silesian University of Technology, Institute of Mathematics, Gliwice, Poland.'}, {'ForeName': 'Patrycja', 'Initials': 'P', 'LastName': 'Łanowy', 'Affiliation': 'Department of Conservative Dentistry with Endodontics, Medical University of Silesia, Faculty of Medical Science, Bytom, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Tanasiewicz', 'Affiliation': 'Department of Conservative Dentistry with Endodontics, Medical University of Silesia, Faculty of Medical Science, Bytom, Poland.'}]",PeerJ,['10.7717/peerj.8981']
1460,31609930,"Switching to Fixed-Dose Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) in Virologically Suppressed HIV-1 Infected Women: A Randomized, Open-Label, Multicenter, Active-Controlled, Phase 3, Noninferiority Trial.","BACKGROUND


Bictegravir, coformulated with emtricitabine/tenofovir alafenamide as a fixed-dose combination (B/F/TAF), is recommended for treatment of HIV-1-infection. Multiple studies of B/F/TAF in treatment-naive and virologically suppressed cohorts have shown high efficacy and tolerability with no treatment-emergent resistance through 48 weeks. Participants in these studies have been predominantly men. We report 48-week results from a phase 3 study evaluating switching to B/F/TAF, specifically in a globally distributed trial population of women.
METHODS


In this multicenter, randomized, open-label, active-controlled, noninferiority trial (ClinicalTrials.gov NCT02652624), women living with HIV who were virologically suppressed (HIV-1 RNA levels <50 copies/mL) on a regimen containing either TAF or tenofovir disoproxil fumarate were randomly assigned (1:1) to switch to B/F/TAF (50/200/25 mg) or stay on baseline regimen (SBR) once daily for 48 weeks. Primary endpoint was proportion of participants with plasma HIV-1 RNA ≥50 copies/mL at week 48 (U.S. Food and Drug Administration snapshot algorithm); prespecified noninferiority margin was 4%.
FINDINGS


We randomized 472 participants and treated 470 (234 B/F/TAF, 236 SBR). Switching to B/F/TAF was noninferior to SBR for the primary outcome, as 1.7% (4/234) vs 1.7% (4/236) had HIV-1 RNA ≥50 copies/mL at week 48 (difference 0.0%, 95.001% confidence interval: -2.9% to 2.9%). No individual receiving B/F/TAF developed treatment-emergent resistance. Both treatments were well-tolerated; no participant discontinued treatment because of an adverse event.
INTERPRETATION


Fixed-dose combination B/F/TAF provides a safe and efficacious option for ongoing treatment of HIV in women. This study contributes important data on safety, tolerability, and outcomes of antiretroviral therapy among women living with HIV.",2019,"mL at week 48 (difference 0.0%, 95.001% confidence interval: -2.9% to 2.9%).","['globally distributed trial population of women', 'Virologically Suppressed HIV-1', 'HIV in women', 'women living with HIV', 'Infected Women', '472 participants and treated 470 (234 B/F/TAF, 236 SBR', 'women living with HIV who were virologically suppressed (HIV-1 RNA levels <50 copies/mL) on a regimen containing either']","['antiretroviral therapy', 'TAF or tenofovir disoproxil fumarate', 'TAF', 'Switching to Fixed-Dose Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF', 'emtricitabine/tenofovir alafenamide']","['safety, tolerability', 'efficacy and tolerability', 'proportion of participants with plasma HIV-1 RNA ≥50 copies']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4507568', 'cui_str': 'bictegravir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C4059167', 'cui_str': 'emtricitabine / tenofovir alafenamide'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]",472.0,0.566234,"mL at week 48 (difference 0.0%, 95.001% confidence interval: -2.9% to 2.9%).","[{'ForeName': 'Cissy', 'Initials': 'C', 'LastName': 'Kityo', 'Affiliation': 'Joint Clinical Research Centre, Kampala, Uganda.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Hagins', 'Affiliation': 'Georgia Department of Public Health, Coastal Health District, Chatham CARE Center, Savannah, GA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Koenig', 'Affiliation': 'Zona Universitaria, Instituto Dominicano de Estudios Virológicos, Santo Domingo, Dominion Republic, Canada.'}, {'ForeName': 'Anchalee', 'Initials': 'A', 'LastName': 'Avihingsanon', 'Affiliation': 'HIV-NAT, Thai Red Cross AIDS Research Centre and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Ploenchan', 'Initials': 'P', 'LastName': 'Chetchotisakd', 'Affiliation': 'Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Khuanchai', 'Initials': 'K', 'LastName': 'Supparatpinyo', 'Affiliation': 'Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Natalya', 'Initials': 'N', 'LastName': 'Gankina', 'Affiliation': 'Krasnoyarsk Territorial Center for Prevention and Control of AIDS and Infectious Diseases, Krasnoyarsk, Russia.'}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Pokrovsky', 'Affiliation': 'Center for Prevention and Control of AIDS, Moscow, Russia.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Voronin', 'Affiliation': 'Federal Budgetary Institution ""Republican Clinical Infectious Hospital"" of the Ministry of Health of the Russian Federation, Saint-Petersburg, Russia.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Stephens', 'Affiliation': 'Mercer University School of Medicine, Macon, GA.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'DeJesus', 'Affiliation': 'Orlando Immunology Center, Orlando, FL.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Gilead Sciences Inc., Foster City, CA.'}, {'ForeName': 'Rima K', 'Initials': 'RK', 'LastName': 'Acosta', 'Affiliation': 'Gilead Sciences Inc., Foster City, CA.'}, {'ForeName': 'Huyen', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Gilead Sciences Inc., Foster City, CA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Quirk', 'Affiliation': 'Gilead Sciences Inc., Foster City, CA.'}, {'ForeName': 'Hal', 'Initials': 'H', 'LastName': 'Martin', 'Affiliation': 'Gilead Sciences Inc., Foster City, CA.'}, {'ForeName': 'Tariro', 'Initials': 'T', 'LastName': 'Makadzange', 'Affiliation': 'Gilead Sciences Inc., Foster City, CA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002137']
1461,32411324,L-Glutamine Supplementation Improves the Benefits of Combined-Exercise Training on Oral Redox Balance and Inflammatory Status in Elderly Individuals.,"Although regular combined aerobic-resistance exercises can ameliorate the inflammatory status and redox balance in elderly population, it is unclear whether protein or specific amino acid supplementation could improve such benefits. Therefore, we aimed to evaluate the inflammatory status and redox indexes through of the saliva of 34 elderly subject nonpractitioners (NP group, 73.3 ± 6.6 years) and 49 elderly subject practitioners of a combined-exercise training in moderate intensity (CET group, 71.9 ± 5.8 years) before (pre) and after (post) 30 days of supplementation with L-glutamine (Gln) or placebo (PL). Our results showed that, both in pre- and postsupplementation, the salivary levels of nitric oxide (NO · ) and TNF- α  were lower, whereas the levels of uric acid and IL-10 (as well as IL-10/TNF- α  ratio) were higher in the CET groups than in the NP groups. In postsupplementation, both groups supplemented with Gln (NP-Gln and CET-Gln) showed higher salivary uric acid levels compared to baseline. In addition, lower NO ·  levels were found in the CET-Gln group postsupplementation than presupplementation values. Whereas the CET-Gln group showed lower GSH levels postsupplementation, NP-Gln subjects showed lower GSSG levels at the same time point, both compared to baseline. Interestingly, salivary peroxidase activity was lower only in NP groups (NP-PL and NP-Gln) postsupplementation than baseline values. A positive significant correlation between salivary peroxidase activity and GSH levels, and also between salivary peroxidase activity and uric acid levels were observed in the CET-Gln group both pre- and postsupplementation. No differences were found in albumin, total antioxidant activity (TEAC), and reducing power analysis between groups, pre- or postsupplementation. In conclusion, the elderly subjects from the CET group showed a better inflammatory response and redox balance and, for the first time, it was shown that daily supplementation with Gln for 30 days can improve these benefits with putative association with a healthy aging.",2020,"No differences were found in albumin, total antioxidant activity (TEAC), and reducing power analysis between groups, pre- or postsupplementation.","['34 elderly subject nonpractitioners (NP group, 73.3 ± 6.6 years) and 49 elderly subject practitioners of a combined-exercise training in moderate intensity (CET group, 71.9 ± 5.8 years) before (pre) and after (post) 30 days of', 'Elderly Individuals', 'elderly population']","['CET-Gln', 'L-Glutamine Supplementation', 'CET', 'Combined-Exercise Training', 'Gln (NP-Gln and CET-Gln', 'supplementation with L-glutamine (Gln) or placebo (PL', 'regular combined aerobic-resistance exercises']","['salivary uric acid levels', 'levels of uric acid and IL-10', 'GSSG levels', 'salivary peroxidase activity and GSH levels', 'GSH levels', 'salivary peroxidase activity and uric acid levels', 'inflammatory response and redox balance', 'albumin, total antioxidant activity (TEAC), and reducing power analysis', 'salivary peroxidase activity', 'salivary levels of nitric oxide (NO · ) and TNF- α', 'Oral Redox Balance and Inflammatory Status']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0007735', 'cui_str': 'Cephalothin'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0007735', 'cui_str': 'Cephalothin'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0061516', 'cui_str': 'Glutathione Disulfide'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.0381931,"No differences were found in albumin, total antioxidant activity (TEAC), and reducing power analysis between groups, pre- or postsupplementation.","[{'ForeName': 'Ewin B', 'Initials': 'EB', 'LastName': 'Almeida', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Juliana M B', 'Initials': 'JMB', 'LastName': 'Santos', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Vitória', 'Initials': 'V', 'LastName': 'Paixão', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Jonatas B', 'Initials': 'JB', 'LastName': 'Amaral', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Foster', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Adriane', 'Initials': 'A', 'LastName': 'Sperandio', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Tamaris', 'Initials': 'T', 'LastName': 'Roseira', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Rossi', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Telma G', 'Initials': 'TG', 'LastName': 'Cordeiro', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Fernanda R', 'Initials': 'FR', 'LastName': 'Monteiro', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Gislene R', 'Initials': 'GR', 'LastName': 'Amirato', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Carlos A F', 'Initials': 'CAF', 'LastName': 'Santos', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Rodolfo P', 'Initials': 'RP', 'LastName': 'Vieira', 'Affiliation': 'Brazilian Institute of Teaching and Research in Pulmonary and Exercise Immunology (IBEPIPE), Rua Pedro Ernesto 240, São José dos Campos, SP 12245-520, Brazil.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Vaisberg', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Marcelo P', 'Initials': 'MP', 'LastName': 'Barros', 'Affiliation': 'Interdisciplinary Postgraduate Program in Health Sciences, Institute of Physical Activity Sciences and Sports (ICAFE), Cruzeiro do Sul University, Rua Galvão Bueno 868, São Paulo, SP 01506-000, Brazil.'}, {'ForeName': 'André L L', 'Initials': 'ALL', 'LastName': 'Bachi', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}]",Oxidative medicine and cellular longevity,['10.1155/2020/2852181']
1462,32411343,Evaluation of Inflammatory Markers in Patients Undergoing a Short-Term Aerobic Exercise Program while Hospitalized due to Acute Exacerbation of COPD.,"Introduction


Acute exacerbation is an important factor for a worse prognosis in patients with chronic obstructive pulmonary disease (COPD). It promotes the increase of the inflammatory process and worsens quality of life, lung function, and muscle weakness. It is believed that physical exercise performed during the exacerbation breaks the vicious cycle of systemic manifestations without an increase in the inflammatory process.
Objective


To evaluate the influence of short-term aerobic physical exercise during hospitalization on inflammatory markers.  Patients and Methods . 26 patients were evaluated (69.2% female, FEV 137.5 ± 12.9%, and age 68.4 ± 11.6 years) 24 hours after hospitalization for smoking history, Charlson index, quality of life, systemic inflammatory markers, and body composition. After 48 hours of hospitalization, all patients underwent a 6-minute walk test (6MWT) and a new spirometry test, and BODE index was calculated. After 72 hours of hospitalization, patients in the intervention group underwent aerobic exercise on a treadmill for 15 minutes twice daily; before and after the aerobic exercise, blood samples were collected for evaluation of inflammatory markers. Finally, a month after hospital discharge, all patients were reevaluated according to systemic inflammatory markers, quality of life, body composition, spirometry, 6MWT, and BODE index.
Results


Patients of both groups did not differ in severity of disease and general characteristics. The intervention group did not show worsening in the inflammatory process after aerobic activity: TNF- α  from 1.19 (0 99-1.71) to 1.21 (0.77-1.53) ( p  = 0.58), IL-6 from 2.41 (2.02-0.58) to 2.66 (1.69-0.48) ( p  = 0.21), and CRP from 3.88 (2.26-8.04) to 4.07 (2.65-13.3) ( p  = 0.56). There was a negative correlation between the IL-6 marker and the 6MWT; that is, with the reduction in inflammatory levels, there was an improvement in exercise capacity one month after hospital discharge.
Conclusion


The present study showed that the aerobic physical activity initiated during hospitalization in patients with exacerbated COPD did not worsen the inflammatory process.",2020,"The intervention group did not show worsening in the inflammatory process after aerobic activity: TNF- α  from 1.19 (0 99-1.71) to 1.21 (0.77-1.53) ( p  = 0.58), IL-6 from 2.41 (2.02-0.58) to 2.66 (1.69-0.48) ( p  = 0.21), and CRP from 3.88 (2.26-8.04) to 4.07 (2.65-13.3) ( p  = 0.56).","['patients with chronic obstructive pulmonary disease (COPD', 'patients with exacerbated COPD', 'Patients Undergoing a Short-Term Aerobic Exercise Program while Hospitalized due to Acute Exacerbation of COPD', '26 patients were evaluated (69.2% female, FEV 137.5\u2009±\u200912.9%, and age 68.4\u2009±\u200911.6 years) 24 hours after hospitalization for smoking history, Charlson index, quality of life, systemic inflammatory markers, and body composition']","['short-term aerobic physical exercise', 'aerobic exercise']","['inflammatory levels', '6-minute walk test (6MWT) and a new spirometry test, and BODE index', 'inflammatory process and worsens quality of life, lung function, and muscle weakness', 'severity of disease and general characteristics', 'systemic inflammatory markers, quality of life, body composition, spirometry, 6MWT, and BODE index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",26.0,0.0394306,"The intervention group did not show worsening in the inflammatory process after aerobic activity: TNF- α  from 1.19 (0 99-1.71) to 1.21 (0.77-1.53) ( p  = 0.58), IL-6 from 2.41 (2.02-0.58) to 2.66 (1.69-0.48) ( p  = 0.21), and CRP from 3.88 (2.26-8.04) to 4.07 (2.65-13.3) ( p  = 0.56).","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Knaut', 'Affiliation': 'UNESP-Univ Estadual Paulista, Campus de Botucatu, Department of Internal Medicine, Pneumology Area, SP, Brazil.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Bonfanti Mesquita', 'Affiliation': 'UNESP-Univ Estadual Paulista, Campus de Botucatu, Department of Internal Medicine, Pneumology Area, SP, Brazil.'}, {'ForeName': 'Victor Zuniga', 'Initials': 'VZ', 'LastName': 'Dourado', 'Affiliation': 'UNESP-Univ Estadual Paulista, Campus de Botucatu, Department of Internal Medicine, Pneumology Area, SP, Brazil.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'de Godoy', 'Affiliation': 'UNESP-Univ Estadual Paulista, Campus de Botucatu, Department of Internal Medicine, Pneumology Area, SP, Brazil.'}, {'ForeName': 'Suzana E', 'Initials': 'SE', 'LastName': 'Tanni', 'Affiliation': 'UNESP-Univ Estadual Paulista, Campus de Botucatu, Department of Internal Medicine, Pneumology Area, SP, Brazil.'}]",International journal of inflammation,['10.1155/2020/6492720']
1463,32411381,Feasibility of behavioral activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial.,"Background


Depression impacts the lives of millions of people worldwide. Behavioral activation (BA), derived from cognitive behavioral therapy, has the potential for improving depressive symptoms in patients with depression. Studies evaluating the effectiveness of BA specifically in the context of group therapy programs in a hospital setting for patients with depression are limited. In this study, we report findings from a pilot trial evaluating group BA for major depressive disorder.
Objective


The objectives of this pilot trial are to assess the potential of a full trial of BA group therapy in a large-scale tertiary care setting and to provide preliminary information about possible results regarding mood symptoms and quality of life in adults with depression.
Methods


Using a parallel single-cohort pragmatic pilot randomized controlled trial design, we evaluated the potential of conducting a large trial of BA effectiveness among adults with depression. Participants were randomized to the intervention (BA in addition to usual care) or control (support group in addition to usual care) groups and were assessed weekly for 18 consecutive weeks. Participants randomized to intervention underwent 28 2-h group BA therapy visits administered by trained therapists and completed assessments to examine treatment outcomes. Feasibility was measured in terms of enrollment rates (min. 20%), completion rates of study (min. 80%), and completion rates of weekly measurement scales (min. 80%). The reporting of this pilot trial is in accordance with the CONSORT extension for randomized pilot and feasibility trials.
Results


We randomized 20 individuals of mean age of 48.8 years (standard deviation = 9.7) with a DSM-5 diagnosis of major depressive disorder to intervention ( n  = 10) or control ( n  = 10) groups. Based on our feasibility criteria, our recruitment rate was excellent (20/27; 74%), study completion was found to be a moderate (80% of the total participants in both arms completed the study; BA = 100%, control = 60%), and completeness of measurements on a weekly basis was adequate overall (82%; BA = 86%, control = 79%).
Conclusions


The study has demonstrated the potential feasibility to perform a larger scale trial upon modifications to the control group to avoid the low rate of study completion (60%) in this group.
Trial registration


ClinicalTrials NCT02045771, Registered January 22, 2014.",2020,"Behavioral activation (BA), derived from cognitive behavioral therapy, has the potential for improving depressive symptoms in patients with depression.","['patients with depression', 'adults with depression', '20 individuals of mean age of 48.8\u2009years (standard deviation\u2009=\u20099.7) with a DSM-5 diagnosis of major depressive disorder to intervention ( n \u2009=\u200910) or control ( n \u2009=\u200910) groups', 'patients with depression are limited']","['BA group therapy', 'behavioral activation group therapy', 'intervention (BA in addition to usual care) or control (support group in addition to usual care']","['Behavioral activation (BA', 'depressive symptoms and improving quality of life', 'completion rates of weekly measurement scales', 'mood symptoms and quality of life', 'Feasibility']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0681887', 'cui_str': 'Measurement scales'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",20.0,0.127827,"Behavioral activation (BA), derived from cognitive behavioral therapy, has the potential for improving depressive symptoms in patients with depression.","[{'ForeName': 'Alessia', 'Initials': 'A', 'LastName': ""D'Elia"", 'Affiliation': '1Department of Psychiatry and Behavioural Neuroscience, McMaster University, 100 West 5th Street, Hamilton, ON Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Bawor', 'Affiliation': '1Department of Psychiatry and Behavioural Neuroscience, McMaster University, 100 West 5th Street, Hamilton, ON Canada.'}, {'ForeName': 'Brittany B', 'Initials': 'BB', 'LastName': 'Dennis', 'Affiliation': '2Population Genomics Program, Chanchlani Research Centre, McMaster University, 1280 Main St. W, Hamilton, ON Canada.'}, {'ForeName': 'Meha', 'Initials': 'M', 'LastName': 'Bhatt', 'Affiliation': '3Department of Health Research, Evidence and Impact, McMaster University, 1280 Main St. W, Hamilton, ON Canada.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Litke', 'Affiliation': '2Population Genomics Program, Chanchlani Research Centre, McMaster University, 1280 Main St. W, Hamilton, ON Canada.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'McCabe', 'Affiliation': '1Department of Psychiatry and Behavioural Neuroscience, McMaster University, 100 West 5th Street, Hamilton, ON Canada.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Whattam', 'Affiliation': ""4Mood Disorders Program, St. Joseph's Healthcare Hamilton, 100 West 5th St, Hamilton, ON Canada.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Garrick', 'Affiliation': ""4Mood Disorders Program, St. Joseph's Healthcare Hamilton, 100 West 5th St, Hamilton, ON Canada.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': ""O'Neill"", 'Affiliation': '1Department of Psychiatry and Behavioural Neuroscience, McMaster University, 100 West 5th Street, Hamilton, ON Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Simons', 'Affiliation': ""4Mood Disorders Program, St. Joseph's Healthcare Hamilton, 100 West 5th St, Hamilton, ON Canada.""}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Chalmers', 'Affiliation': ""4Mood Disorders Program, St. Joseph's Healthcare Hamilton, 100 West 5th St, Hamilton, ON Canada.""}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Key', 'Affiliation': '1Department of Psychiatry and Behavioural Neuroscience, McMaster University, 100 West 5th Street, Hamilton, ON Canada.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Goyert', 'Affiliation': ""4Mood Disorders Program, St. Joseph's Healthcare Hamilton, 100 West 5th St, Hamilton, ON Canada.""}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Laplante', 'Affiliation': '1Department of Psychiatry and Behavioural Neuroscience, McMaster University, 100 West 5th Street, Hamilton, ON Canada.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Vanstone', 'Affiliation': '3Department of Health Research, Evidence and Impact, McMaster University, 1280 Main St. W, Hamilton, ON Canada.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': '3Department of Health Research, Evidence and Impact, McMaster University, 1280 Main St. W, Hamilton, ON Canada.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Guyatt', 'Affiliation': '3Department of Health Research, Evidence and Impact, McMaster University, 1280 Main St. W, Hamilton, ON Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': '3Department of Health Research, Evidence and Impact, McMaster University, 1280 Main St. W, Hamilton, ON Canada.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Samaan', 'Affiliation': '1Department of Psychiatry and Behavioural Neuroscience, McMaster University, 100 West 5th Street, Hamilton, ON Canada.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00596-z']
1464,32411633,Mucopexy-Recto Anal Lifting (MuRAL) in managing obstructed defecation syndrome associated with prolapsed hemorrhoids and rectocele: preliminary results.,"Purpose


Treatment of rectocele associated with prolapsed hemorrhoids is a debated topic. Transanal stapling achieved good midterm results in patients with symptoms of obstructed defecation, nevertheless a number of severe complications have been reported. The aim of this study was to evaluate the safety and efficacy of a new endorectal manual technique in patients with obstructed defecation due to the combination of muco-hemorrhoidal prolapse and rectocele.
Methods


Patients enrolled after preoperative obstructed defecation syndrome (ODS) score, defecography and anoscopy were submitted to the novel Mucopexy-Recto Anal Lifting (MuRAL) combined with a modified Block procedure, and followed up by independent observers with digital exploration 3 weeks postoperatively, and digital exploration plus anoscopy at 3, 6, and 12 months. Operative time, hospital stay, numerating rating scale (NRS), ODS, satisfaction scores, and recurrence rate were recorded.
Results


Mean operative time was 35.7 minutes. Fifty-six patients completed 1-year follow-up: 7.1% had acute urinary retention, NRS score was < 3 from the third postoperative day, mean time of daily activity resumption was 12 days, none had persistent fecal urgency, 82% declared excellent/good satisfaction score, significant improvement of 6- and 12-month ODS score, no recurrence of rectocele, and 7.1% recurrence of prolapsed hemorrhoids were observed.
Conclusion


MuRAL associated with modified Block technique gave no severe complications and resulted in a safe and effective approach to symptomatic rectocele associated with muco-rectal prolapse. Further randomized studies, larger series, and longer follow-up are needed.",2020,"Fifty-six patients completed 1-year follow-up: 7.1% had acute urinary retention, NRS score was < 3 from the third postoperative day, mean time of daily activity resumption was 12 days, none had persistent fecal urgency, 82% declared excellent/good satisfaction score, significant improvement of 6- and 12-month ODS score, no recurrence of rectocele, and 7.1% recurrence of prolapsed hemorrhoids were observed.
","['patients with obstructed defecation due to the combination of muco-hemorrhoidal prolapse and rectocele', 'Patients enrolled after preoperative obstructed defecation syndrome (ODS) score, defecography and anoscopy were submitted to the']","['Mucopexy-Recto Anal Lifting (MuRAL', 'novel Mucopexy-Recto Anal Lifting (MuRAL) combined with a modified Block procedure, and followed up by independent observers with digital exploration 3 weeks postoperatively, and digital exploration plus anoscopy', 'new endorectal manual technique', 'Transanal stapling']","['Mean operative time', '6- and 12-month ODS score, no recurrence of rectocele, and 7.1% recurrence of prolapsed hemorrhoids', 'Operative time, hospital stay, numerating rating scale (NRS), ODS, satisfaction scores, and recurrence rate', 'acute urinary retention, NRS score', 'safety and efficacy', 'severe complications', 'persistent fecal urgency', 'mean time of daily activity resumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0149771', 'cui_str': 'Herniation of rectum into vagina'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0549186', 'cui_str': 'Obstructed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0524966', 'cui_str': 'Defecography'}, {'cui': 'C0193158', 'cui_str': 'Anoscopy'}]","[{'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0199220', 'cui_str': 'Digital palpation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0193158', 'cui_str': 'Anoscopy'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0589371', 'cui_str': 'Transanal approach'}, {'cui': 'C0185012', 'cui_str': 'Closure by staple'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0549186', 'cui_str': 'Obstructed'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0149771', 'cui_str': 'Herniation of rectum into vagina'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0341742', 'cui_str': 'Acute retention of urine'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0426636', 'cui_str': 'Urgent desire for stool'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",,0.0444938,"Fifty-six patients completed 1-year follow-up: 7.1% had acute urinary retention, NRS score was < 3 from the third postoperative day, mean time of daily activity resumption was 12 days, none had persistent fecal urgency, 82% declared excellent/good satisfaction score, significant improvement of 6- and 12-month ODS score, no recurrence of rectocele, and 7.1% recurrence of prolapsed hemorrhoids were observed.
","[{'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Pagano', 'Affiliation': 'General Surgery Unit, Vizzolo Predabissi Hospital, ASST Milano-Martesana, Vizzolo Predabissi (MI), Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Venturi', 'Affiliation': ""Day/Week Surgery Unit, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Benegiamo', 'Affiliation': 'General Surgery Unit, Vizzolo Predabissi Hospital, ASST Milano-Martesana, Vizzolo Predabissi (MI), Italy.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Melada', 'Affiliation': ""Day/Week Surgery Unit, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Contardo', 'Initials': 'C', 'LastName': 'Vergani', 'Affiliation': ""Day/Week Surgery Unit, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}]",Annals of surgical treatment and research,['10.4174/astr.2020.98.5.277']
1465,31629338,"Is an Elastic Ankle Support Effective in Improving Jump Landing Performance, and Static and Dynamic Balance in Young Adults With and Without Chronic Ankle Instability?","CONTEXT


In some patients, ankle sprains lead to chronic symptoms like pain or muscular weakness called chronic ankle instability (CAI). External ankle supports have shown to be effective in preventing sprains and reducing recurrence, but the underlying mechanisms are unclear. As sensorimotor variables are associated with injury incidence, an influence of external ankle support on landing performance and balance seems plausible.
OBJECTIVE


To analyze the effects of an elastic ankle support on jump landing performance and static and dynamic balance in patients with CAI and healthy controls.
DESIGN


Crossover study.
SETTING


Functional tests in a laboratory setting.
PATIENTS OR OTHER PARTICIPANTS


Twenty healthy students and 20 patients with CAI were included for study participation based on their scores in ankle stability and function questionnaires.
INTERVENTION


Healthy and CAI participants performed each test with and without an elastic ankle support.
MAIN OUTCOME MEASURES


(1) Jump landing performance was measured with the Landing Error Scoring System, (2) static balance was assessed with the Balance Error Scoring System, and (3) dynamic balance was assessed using the Y Balance Test. Linear mixed models were used to analyze the effects of the elastic ankle support on sensorimotor parameters.
RESULTS


Healthy controls performed significantly better in the Landing Error Scoring System (P = .01) and Y Balance Test anterior direction (P = .01). No significant effects of elastic ankle support on Landing Error Scoring System, Balance Error Scoring System, or Y Balance Test performance were observed in the CAI or control group. There were no significant group-by-ankle support interactions.
CONCLUSIONS


In the current study, the acute use of elastic ankle support was ineffective for enhancing jump landing performance, and static and dynamic balance. Further research is needed to identify the underlying mechanisms of the preventive effects of elastic ankle support.",2019,"No significant effects of elastic ankle support on Landing Error Scoring System, Balance Error Scoring System, or Y Balance Test performance were observed in the CAI or control group.","['patients with CAI and healthy controls', 'Young Adults', 'Twenty healthy students and 20 patients with CAI']",['elastic ankle support'],"['Jump Landing Performance, and Static and Dynamic Balance', 'Landing Error Scoring System, (2)\xa0static balance was assessed with the Balance Error Scoring System, and (3)\xa0dynamic balance', 'Landing Error Scoring System', 'jump landing performance and static and dynamic balance', 'ankle stability and function questionnaires', 'jump landing performance, and static and dynamic balance', 'Landing Error Scoring System, Balance Error Scoring System, or Y Balance Test performance', '1)\xa0Jump landing performance', 'Y Balance Test anterior direction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0557668', 'cui_str': 'Landing (environment)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}]",20.0,0.0256553,"No significant effects of elastic ankle support on Landing Error Scoring System, Balance Error Scoring System, or Y Balance Test performance were observed in the CAI or control group.","[{'ForeName': 'Cornelius', 'Initials': 'C', 'LastName': 'John', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Stotz', 'Affiliation': ''}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Gmachowski', 'Affiliation': ''}, {'ForeName': 'Anna Lina', 'Initials': 'AL', 'LastName': 'Rahlf', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hamacher', 'Affiliation': ''}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Hollander', 'Affiliation': ''}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Zech', 'Affiliation': ''}]",Journal of sport rehabilitation,['10.1123/jsr.2019-0147']
1466,31613706,A Pilot and Feasibility Study of Oatmeal Consumption in Children to Assess Markers of Bowel Function.,"Inadequate dietary fiber intake contributes to irregular bowel movements and may contribute to difficulty with defecation in children. Whole grain foods, such as oatmeal, may improve stool consistency and stool frequency in children; however, no studies have examined its effects. The purpose of this study was to investigate if 2 weeks of oatmeal consumption in children (ages 7-12 years) increases stool frequency, improves stool consistency, and gastrointestinal (GI) symptoms. In this single-arm intervention study, children who reported ≤5 bowel movements per week during screening, consumed two servings of instant oatmeal daily for 2 weeks. The primary outcome was stool frequency and secondary outcomes included stool consistency and GI symptoms. Participants recorded bowel movements daily, food intake, and GI symptoms during baseline and 2 intervention weeks. Photos of the children's stool were taken at three timepoints during the study to assess stool consistency. In total, 33 children (15 female and 18 male) completed the study. Linear mixed models were used to detect change between baseline and the intervention weeks and accounted for repeated measures within subjects. No statistical differences in stool frequency or consistency were observed between the intervention weeks vs. baseline; however, dietary fiber intake significantly increased during the 2 weeks of oatmeal consumption ( P  = .008). The addition of oatmeal to children's diets is an effective way to increase fiber consumption and may reduce some GI symptoms such as gas, straining, and feeling of incomplete evacuation. Trial identification number: NCT02868515.",2020,"No statistical differences in stool frequency or consistency were observed between the intervention weeks vs. baseline; however, dietary fiber intake significantly increased during the 2 weeks of oatmeal consumption ( P  = .008).","['Children to Assess Markers of Bowel Function', 'children', '33 children (15 female and 18 male) completed the study', 'children (ages 7-12 years']",['Oatmeal Consumption'],"['stool consistency and stool frequency', 'stool frequency, improves stool consistency, and gastrointestinal (GI) symptoms', 'stool frequency or consistency', 'stool consistency and GI symptoms', 'dietary fiber intake', 'bowel movements daily, food intake, and GI symptoms', 'stool frequency']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0452680', 'cui_str': 'Oatmeal (substance)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0474451', 'cui_str': 'Dietary fiber intake (observable entity)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]",33.0,0.133884,"No statistical differences in stool frequency or consistency were observed between the intervention weeks vs. baseline; however, dietary fiber intake significantly increased during the 2 weeks of oatmeal consumption ( P  = .008).","[{'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Paruzynski', 'Affiliation': 'Department of Food Science and Nutrition, University of Minnesota, St. Paul, Minnesota, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Korczak', 'Affiliation': 'Department of Food Science and Nutrition, University of Minnesota, St. Paul, Minnesota, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Clinical and Translational Science Institute, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Slavin', 'Affiliation': 'Department of Food Science and Nutrition, University of Minnesota, St. Paul, Minnesota, USA.'}]",Journal of medicinal food,['10.1089/jmf.2019.0158']
1467,32052264,"Results of Mirogabalin Treatment for Diabetic Peripheral Neuropathic Pain in Asian Subjects: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Study.","INTRODUCTION


Almost one-quarter of Asian patients with diabetes experience diabetic peripheral neuropathic pain (DPNP), which may be associated with moderate or severe levels of pain, insomnia, mood disorders, and worsened quality of life. Current treatments are generally ineffective and may be poorly tolerated. We evaluated mirogabalin as a treatment for DPNP in Asian subjects.
METHODS


This phase 2, randomized, double-blind, controlled study was conducted in Japan, South Korea, and Taiwan. Subjects (n = 450) with DPNP were randomized (1:1:1:1:1) to treatment with 5, 10, or 15 mg twice-daily (BID) mirogabalin, 150 mg BID pregabalin, or placebo. The primary endpoint was change from baseline in average daily pain score (ADPS) at week 7; secondary endpoints included responder rates, Short-Form McGill Pain Questionnaire (SF-MPQ), Patient Global Impression of Change (PGIC), average daily sleep-interference score (ADSIS), and incidence of treatment-emergent adverse events (TEAEs).
RESULTS


A greater improvement was noted for each mirogabalin treatment group for change from baseline in ADPS at week 7 compared with both placebo and with pregabalin, although these improvements were not statistically significant. The percentage of 30, 50, and 75% responders and subjects with PGIC improvements was greater in each mirogabalin group versus placebo. Mirogabalin 15 mg BID significantly improved the SF-MPQ sensory (p = 0.0313) and visual analog scale scores (p = 0.0093), and ADSIS (p = 0.0002), versus placebo. Treatment was generally well tolerated; the most frequently reported TEAEs in the mirogabalin groups were somnolence (14.7%) and dizziness (11.0%), and most AEs were mild or moderate even at the highest dose.
CONCLUSIONS


In Asian subjects with DPNP, mirogabalin (5, 10, and 15 mg BID) was well tolerated. Although no significant differences were observed in the primary endpoint, there was a tendency toward improvement of pain with mirogabalin treatment, and this trend was also observed in the secondary endpoints.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT01504412.",2020,"Mirogabalin 15 mg BID significantly improved the SF-MPQ sensory (p = 0.0313) and visual analog scale scores (p = 0.0093), and ADSIS (p = 0.0002), versus placebo.","['Japan, South Korea, and Taiwan', 'Asian Subjects', 'Subjects (n\u2009=\u2009450) with DPNP', 'Asian patients with diabetes experience diabetic peripheral neuropathic pain (DPNP', 'Asian subjects']","['Placebo', 'Mirogabalin Treatment', 'pregabalin', '15\xa0mg twice-daily (BID) mirogabalin, 150\xa0mg BID pregabalin, or placebo', 'placebo']","['PGIC improvements', 'SF-MPQ sensory', 'visual analog scale scores', 'average daily pain score (ADPS', 'tolerated', 'Diabetic Peripheral Neuropathic Pain', 'responder rates, Short-Form McGill Pain Questionnaire (SF-MPQ), Patient Global Impression of Change (PGIC), average daily sleep-interference score (ADSIS), and incidence of treatment-emergent adverse events (TEAEs', 'pain', 'somnolence', 'dizziness']","[{'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963916', 'cui_str': 'Diabetic peripheral neuropathic pain'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4043827', 'cui_str': 'mirogabalin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1963916', 'cui_str': 'Diabetic peripheral neuropathic pain'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire (assessment scale)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",450.0,0.483313,"Mirogabalin 15 mg BID significantly improved the SF-MPQ sensory (p = 0.0313) and visual analog scale scores (p = 0.0093), and ADSIS (p = 0.0002), versus placebo.","[{'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Baba', 'Affiliation': 'Aomori Prefectural Central Hospital, Aomori, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Kuroha', 'Affiliation': 'Clinical Development Department, Daiichi Sankyo Co., Ltd, Tokyo, Japan. kuroha.masanori.kh@daiichisankyo.co.jp.'}, {'ForeName': 'Shoichi', 'Initials': 'S', 'LastName': 'Ohwada', 'Affiliation': 'Biostatistics and Data Management Department, Daiichi Sankyo Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Emiko', 'Initials': 'E', 'LastName': 'Murayama', 'Affiliation': 'Asia Development Department, Daiichi Sankyo Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Norimitsu', 'Initials': 'N', 'LastName': 'Matsui', 'Affiliation': 'Clinical Development Department, Daiichi Sankyo Co., Ltd, Tokyo, Japan.'}]",Pain and therapy,['10.1007/s40122-020-00156-6']
1468,32411717,Intravenous Cyclophosphamide in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. An Open-Label Phase II Study.,"Introduction:  Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a disease with high symptom burden, of unknown etiology, with no established treatment. We observed patients with long-standing ME/CFS who got cancer, and who reported improvement of ME/CFS symptoms after chemotherapy including cyclophosphamide, forming the basis for this prospective trial.  Materials and methods:  This open-label phase II trial included 40 patients with ME/CFS diagnosed by Canadian criteria. Treatment consisted of six intravenous infusions of cyclophosphamide, 600-700 mg/m 2 , given at four-week intervals with follow-up for 18 months, extended to 4 years. Response was defined by self-reported improvements in symptoms by Fatigue score, supported by Short Form 36 (SF-36) scores, physical activity measures and other instruments. Repeated measures of outcome variables were assessed by General linear models. Responses were correlated with specific Human Leukocyte Antigen (HLA) alleles.  Results:  The overall response rate by Fatigue score was 55.0% (22 of 40 patients). Fatigue score and other outcome variables showed significant improvements compared to baseline. The SF-36 Physical Function score increased from mean 33.0 at baseline to 51.5 at 18 months (all patients), and from mean 35.0 to 69.5 among responders. Mean steps per 24 h increased from mean 3,199 at baseline to 4,347 at 18 months (all patients), and from 3,622 to 5,589 among responders. At extended follow-up to 4 years 68% (15 of 22 responders) were still in remission. Patients positive for HLA-DQB1 * 03:03 and/or HLA-C * 07:04 ( n  = 12) had significantly higher response rate compared to patients negative for these alleles ( n  = 28), 83 vs. 43%, respectively. Nausea and constipation were common grade 1-2 adverse events. There were one suspected unexpected serious adverse reaction (aggravated POTS) and 11 serious adverse events in eight patients.  Conclusion:  Intravenous cyclophosphamide treatment was feasible for ME/CFS patients and associated with an acceptable toxicity profile. More than half of the patients responded and with prolonged follow-up, a considerable proportion of patients reported ongoing remission. Without a placebo group, clinical response data must be interpreted with caution. We nevertheless believe a future randomized trial is warranted.  Clinical Trial Registration:  www.ClinicalTrials.gov, identifier: NCT02444091.",2020,"The SF-36 Physical Function score increased from mean 33.0 at baseline to 51.5 at 18 months (all patients), and from mean 35.0 to 69.5 among responders.","['40 patients with ME/CFS diagnosed by Canadian criteria', 'Myalgic Encephalomyelitis/Chronic Fatigue Syndrome']","['Intravenous Cyclophosphamide', 'Intravenous cyclophosphamide', 'cyclophosphamide', 'placebo']","['specific Human Leukocyte Antigen (HLA) alleles', 'Fatigue score', 'Nausea and constipation', 'acceptable toxicity profile', 'overall response rate by Fatigue score', 'HLA-DQB1', 'SF-36 Physical Function score', 'ME/CFS symptoms', 'serious adverse reaction (aggravated POTS) and 11 serious adverse events', 'Mean steps per 24 h', 'response rate', 'symptoms by Fatigue score, supported by Short Form 36 (SF-36) scores, physical activity measures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0555907', 'cui_str': 'Human leukocyte antigen allele'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0122020', 'cui_str': 'HLA-DQB1 antigen'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0024809', 'cui_str': 'Marihuana Abuse'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",40.0,0.0705803,"The SF-36 Physical Function score increased from mean 33.0 at baseline to 51.5 at 18 months (all patients), and from mean 35.0 to 69.5 among responders.","[{'ForeName': 'Ingrid G', 'Initials': 'IG', 'LastName': 'Rekeland', 'Affiliation': 'Department of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fosså', 'Affiliation': 'Department of Oncology, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Asgeir', 'Initials': 'A', 'LastName': 'Lande', 'Affiliation': 'Department of Medical Genetics, Oslo University Hospital and Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Irini', 'Initials': 'I', 'LastName': 'Ktoridou-Valen', 'Affiliation': 'Department of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Sørland', 'Affiliation': 'Department of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Holsen', 'Affiliation': 'Clinical Research Unit, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Karl J', 'Initials': 'KJ', 'LastName': 'Tronstad', 'Affiliation': 'Department of Biomedicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Risa', 'Affiliation': 'Department of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Kine', 'Initials': 'K', 'LastName': 'Alme', 'Affiliation': 'Department of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Marte K', 'Initials': 'MK', 'LastName': 'Viken', 'Affiliation': 'Department of Medical Genetics, Oslo University Hospital and Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Benedicte A', 'Initials': 'BA', 'LastName': 'Lie', 'Affiliation': 'Department of Medical Genetics, Oslo University Hospital and Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Dahl', 'Affiliation': 'Department of Biomedicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Mella', 'Affiliation': 'Department of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Øystein', 'Initials': 'Ø', 'LastName': 'Fluge', 'Affiliation': 'Department of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.'}]",Frontiers in medicine,['10.3389/fmed.2020.00162']
1469,31593830,Efficacy of molecularly targeted agents given in the randomised trial SHIVA01 according to the ESMO Scale for Clinical Actionability of molecular Targets.,"BACKGROUND


A randomised trial SHIVA01 compared the efficacy of matched molecularly targeted therapy outside their indications based on a prespecified treatment algorithm versus conventional chemotherapy in patients with metastatic solid tumours who had failed standard of care. No statistical difference was reported between the two groups in terms of progression-free survival (PFS), challenging treatment algorithm. The European Society for Medical Oncology (ESMO) Scale for Clinical Actionability of molecular Targets (ESCAT) recently defined criteria to prioritise molecular alterations (MAs) to select anticancer drugs. We aimed to retrospectively evaluate the efficacy of matched molecularly targeted agents (MTAs) given in SHIVA01 according to ESCAT tiers.
PATIENTS AND METHODS


MAs used in SHIVA01 were retrospectively classified into ESCAT tiers, and PFS and overall survival (OS) were compared using log-rank tests.
RESULTS


One hundred fifty-three patients were treated with matched MTAs in SHIVA01. MAs used to allocate MTAs were classified into tiers II, IIIA, IIIB and IVA according to the ESCAT. Median PFS was 2.0 months in tier II, 3.1 in tier IIIA, 1.7 in tier IIIB and 3.2 in tier IVA (p = 0.13). Median OS in tier IIIB was worse than that in tiers II, IIIA and IVA (6.3 months versus 11.7, 11.2 and 12.1, p = 0.002).
CONCLUSIONS


Most MAs used to allocate therapy in SHIVA01 were shown to improve outcomes in other tumour types (tier IIIA). Worst outcome was observed in patients treated based on another type of alteration than the one reported to improve outcomes (tier IIIB), highlighting the crucial impact of the type of the alterations beyond the gene and the signalling pathway.",2019,"No statistical difference was reported between the two groups in terms of progression-free survival (PFS), challenging treatment algorithm.","['One hundred fifty-three patients were treated with matched MTAs in SHIVA01', 'patients with metastatic solid tumours who had failed standard of care']","['IVA', 'conventional chemotherapy']","['progression-free survival (PFS', 'Median PFS', 'Median OS in tier IIIB', 'PFS and overall survival (OS']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",153.0,0.045081,"No statistical difference was reported between the two groups in terms of progression-free survival (PFS), challenging treatment algorithm.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moreira', 'Affiliation': 'Department of Drug Development and Innovation (D3i), Institut Curie, Paris, Saint-Cloud, France. Electronic address: aurelie.moreira@curie.fr.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Masliah-Planchon', 'Affiliation': 'Department of Genetics, Institut Curie, PSL Research University, Paris, France. Electronic address: julien.masliahplanchon@curie.fr.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Callens', 'Affiliation': 'Department of Genetics, Institut Curie, PSL Research University, Paris, France. Electronic address: celine.callens@curie.fr.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Vacher', 'Affiliation': 'Department of Genetics, Institut Curie, PSL Research University, Paris, France. Electronic address: sophie.vacher@curie.fr.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lecerf', 'Affiliation': 'Department of Drug Development and Innovation (D3i), Institut Curie, Paris, Saint-Cloud, France. Electronic address: charlotte.lecerf@curie.fr.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Frelaut', 'Affiliation': 'Department of Drug Development and Innovation (D3i), Institut Curie, Paris, Saint-Cloud, France. Electronic address: maxime.frelaut@curie.fr.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Borcoman', 'Affiliation': 'Department of Drug Development and Innovation (D3i), Institut Curie, Paris, Saint-Cloud, France. Electronic address: edith.borcoman@curie.fr.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Torossian', 'Affiliation': 'Department of Drug Development and Innovation (D3i), Institut Curie, Paris, Saint-Cloud, France. Electronic address: nouritza.torossian@curie.fr.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ricci', 'Affiliation': 'Department of Drug Development and Innovation (D3i), Institut Curie, Paris, Saint-Cloud, France. Electronic address: francesco.ricci@curie.fr.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hescot', 'Affiliation': 'Department of Drug Development and Innovation (D3i), Institut Curie, Paris, Saint-Cloud, France. Electronic address: segolene.hescot@curie.fr.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Sablin', 'Affiliation': 'Department of Drug Development and Innovation (D3i), Institut Curie, Paris, Saint-Cloud, France. Electronic address: mariepaule.sablin@curie.fr.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Tresca', 'Affiliation': 'Department of Drug Development and Innovation (D3i), Institut Curie, Paris, Saint-Cloud, France. Electronic address: patricia.tresca@curie.fr.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Loirat', 'Affiliation': 'Department of Drug Development and Innovation (D3i), Institut Curie, Paris, Saint-Cloud, France. Electronic address: delphine.loirat@curie.fr.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Melaabi', 'Affiliation': 'Department of Genetics, Institut Curie, PSL Research University, Paris, France. Electronic address: samia.melaabi@curie.fr.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Trabelsi-Grati', 'Affiliation': 'Department of Genetics, Institut Curie, PSL Research University, Paris, France. Electronic address: olfa.trabelsigrati@curie.fr.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pierron', 'Affiliation': 'Department of Genetics, Institut Curie, PSL Research University, Paris, France. Electronic address: gaelle.pierron@curie.fr.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Gentien', 'Affiliation': 'Department of Translational Research, Institut Curie, PSL Research University, Paris, France. Electronic address: david.gentien@curie.fr.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Bernard', 'Affiliation': 'Department of Genetics, Institut Curie, PSL Research University, Paris, France. Electronic address: Virginie.Bernard@curie.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vincent Salomon', 'Affiliation': 'Department of Pathology, Institut Curie, PSL Research University, Paris, France. Electronic address: anne.salomon@curie.fr.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Servant', 'Affiliation': 'INSERM U900, Institut Curie, Mines Paris Tech, Paris, France. Electronic address: nicolas.servant@curie.fr.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bieche', 'Affiliation': 'Department of Genetics, Institut Curie, PSL Research University, Paris, France; INSERM U1016 Research Unit, Cochin Institute, Paris, France. Electronic address: ivan.bieche@curie.fr.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Le Tourneau', 'Affiliation': 'Department of Drug Development and Innovation (D3i), Institut Curie, Paris, Saint-Cloud, France; INSERM U900, Institut Curie, Mines Paris Tech, Paris, France; Paris-Saclay University, Paris, France. Electronic address: christophe.letourneau@curie.fr.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kamal', 'Affiliation': 'Department of Drug Development and Innovation (D3i), Institut Curie, Paris, Saint-Cloud, France. Electronic address: maud.kamal@curie.fr.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.09.001']
1470,30498827,Dairy-Based and Energy-Enriched Berry-Based Snacks Improve or Maintain Nutritional and Functional Status in Older People in Home Care.,"OBJECTIVE


Consumption of energy- and nutrient-dense snacks are recommended for older people to maintain adequate nutrition. We evaluated the effects of dairy-based and energy-enriched berry products consumed as snacks on nutritional and functional status among vulnerable older people receiving home care services.
DESIGN


Randomised controlled study.
SETTING AND PARTICIPANTS


The study sample consisted of 85 home care clients, with mean age of 81.9 (SD 7.1) years in the intervention group (n=50) and 83.7 (SD 8.1) years in the control group (n=35), and 72% women in both groups.
INTERVENTION


In the intervention group, the participants consumed both high-protein dairy-based products and energy-enriched berry purées for three months. The snack products provided nearly 300 kcal and 14 g protein per day.
MEASUREMENTS


The Mini Nutritional Assessment (MNA), body mass index (BMI), mid-arm muscular area (MAMA) and concentrations of plasma albumin and prealbumin and blood haemoglobin were used to determine nutritional status, and handgrip strength was used to determine functional status at baseline and after the intervention.
RESULTS


After adjustment for age and gender, the intervention showed a significant effect on MNA scores (2.1, 95% [CI]: 1.0 to 3.3) (p=0.003), albumin concentration (2.0 g/L, 95% [CI]: 1.1 to 3.2) (p=0.006) and handgrip strength of the right hand in women (2.4 kg, 95% [CI]: 1.2 to 3.3) (p=0.007). The MNA scores improved in the intervention group, while albumin concentration and handgrip strength decreased in the control group.
CONCLUSIONS


Regular use of dairy- and energy-enriched berry-based snacks may improve or maintain nutritional and functional status among older people in home care.",2018,"The MNA scores improved in the intervention group, while albumin concentration and handgrip strength decreased in the control group.
","['older people to maintain adequate nutrition', 'vulnerable older people receiving home care services', 'older people in home care', 'Older People in Home Care', '85 home care clients, with mean age of 81.9 (SD 7.1) years in the intervention group (n=50) and 83.7 (SD 8.1) years in the control group (n=35), and 72% women in both groups']","['dairy- and energy-enriched berry-based snacks', 'dairy-based and energy-enriched berry products consumed as snacks', 'energy- and nutrient-dense snacks', 'Dairy-Based and Energy-Enriched Berry-Based Snacks']","['albumin concentration', 'Mini Nutritional Assessment (MNA), body mass index (BMI), mid-arm muscular area (MAMA) and concentrations of plasma albumin and prealbumin and blood haemoglobin', 'nutritional status, and handgrip strength', 'handgrip strength', 'albumin concentration and handgrip strength', 'MNA scores']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0019855', 'cui_str': 'Domiciliary Care'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517875', 'cui_str': '8.1 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0005135', 'cui_str': 'Berries'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}]","[{'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3850124', 'cui_str': 'Mini Nutrition Assessment'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1260311', 'cui_str': 'Plasma Albumin'}, {'cui': 'C0032923', 'cui_str': 'Transthyretin'}, {'cui': 'C0005768'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0434736,"The MNA scores improved in the intervention group, while albumin concentration and handgrip strength decreased in the control group.
","[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Nykänen', 'Affiliation': 'Irma Nykänen, Institute of Public Health and Clinical Nutrition, University of Eastern Finland, P.O. Box 1627, FI-70211 Kuopio, Finland Phone: +358 40 355 2991, Fax: +358 17 162 131, E-mail: Irma.Nykanen@uef.fi.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Törrönen', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Schwab', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-018-1076-7']
1471,31602811,Aflibercept and navigated versus conventional laser in diabetic macular oedema: a 12-month randomized clinical trial.,"PURPOSE


To examine the efficacy of intravitreal aflibercept and navigated laser as compared to intravitreal aflibercept and conventional laser in diabetic macular oedema (DME) treatment.
METHODS


In 12-month randomized clinical trial, 48 eyes of 37 patients with centre-involved DME at Odense University Hospital were randomized 1:1 to receive three monthly injections of aflibercept followed by navigated (group A) or conventional (group B) focal/grid laser. From month four through twelve, patients were examined monthly, and additional injections were given pro re nata (PRN) (central retinal thickness [CRT]>20% from lowest measurement or loss in visual acuity [VA]>5 Early Treatment Diabetic Retinopathy Study [ETDRS] letters compared with baseline). Outcome measures; (1) percentage of eyes that needed additional injections after laser in group A and B, (2) mean number of injections in group A and B, and (3) mean change in VA and CRT in group A and B.
RESULTS


In the PRN phase, 60.5% of patients needed additional injections without differences between groups A and B (58.3 versus 63.2%, p > 0.99). The mean number of injections between baseline and month 12 was 4.4 (4.2 versus 4.6, p = 0.41). From baseline to month 12, VA improved by 8.4 ETDRS letters, and CRT was reduced by 97.4 μm (+9.4 versus +7.1 letters, p = 0.17, and -83.2 versus -115.4 μm, p = 0.21).
CONCLUSION


No difference in need for retreatment was detected between treatment arms of aflibercept and navigated versus conventional laser.",2020,No difference in need for retreatment was detected between treatment arms of aflibercept and navigated versus conventional laser.,"['diabetic macular oedema', '48 eyes of 37 patients with centre-involved DME at Odense University Hospital', 'diabetic macular oedema (DME) treatment']","['intravitreal aflibercept and conventional laser', 'Aflibercept and navigated versus conventional laser', 'intravitreal aflibercept and navigated laser', 'pro re nata (PRN) (central retinal thickness [CRT]>20% from lowest measurement or loss in visual acuity [VA]>5 Early Treatment Diabetic Retinopathy Study [ETDRS] letters', 'aflibercept followed by navigated (group A) or conventional (group B) focal/grid laser']","['mean number of injections', 'CRT', 'Outcome measures; (1) percentage of eyes that needed additional injections', 'need for retreatment']","[{'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0641456', 'cui_str': 'DMES'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0067792', 'cui_str': 'NATA'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}]",,0.137379,No difference in need for retreatment was detected between treatment arms of aflibercept and navigated versus conventional laser.,"[{'ForeName': 'Søren L', 'Initials': 'SL', 'LastName': 'Blindbaek', 'Affiliation': 'Department of Ophthalmology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Peto', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Grauslund', 'Affiliation': 'Department of Ophthalmology, Odense University Hospital, Odense, Denmark.'}]",Acta ophthalmologica,['10.1111/aos.14266']
1472,31607467,"Strategies to improve control of sexually transmissible infections in remote Australian Aboriginal communities: a stepped-wedge, cluster-randomised trial.","BACKGROUND


Remote Australian Aboriginal communities have among the highest diagnosed rates of sexually transmissible infections (STIs) in the world. We did a trial to assess whether continuous improvement strategies related to sexual health could reduce infection rates.
METHODS


In this stepped-wedge, cluster-randomised trial (STIs in remote communities: improved and enhanced primary health care [STRIVE]), we recruited primary health-care centres serving Aboriginal communities in remote areas of Australia. Communities were eligible to participate if they were classified as very remote, had a population predominantly of Aboriginal people, and only had one primary health-care centre serving the population. The health-care centres were grouped into clusters on the basis of geographical proximity to each other, population size, and Aboriginal cultural ties including language connections. Clusters were randomly assigned into three blocks (year 1, year 2, and year 3 clusters) using a computer-generated randomisation algorithm, with minimisation to balance geographical region, population size, and baseline STI testing level. Each year for 3 years, one block of clusters was transitioned into the intervention phase, while those not transitioned continued usual care (control clusters). The intervention phase comprised cycles of reviewing clinical data and modifying systems to support improved STI clinical practice. All investigators and participants were unmasked to the intervention. Primary endpoints were community prevalence and testing coverage in residents aged 16-34 years for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. We used Poisson regression analyses on the final dataset and compared STI prevalences and testing coverage between control and intervention clusters. All analyses were by intention to treat and models were adjusted for time as an independent covariate in overall analyses. This study was registered with the Australia and New Zealand Clinical Trials Registry, ACTRN12610000358044.
FINDINGS


Between April, 2010, and April, 2011, we recruited 68 primary care centres and grouped them into 24 clusters, which were randomly assigned into year 1 clusters (estimated population aged 16-34 years, n=11 286), year 2 clusters (n=10 288), or year 3 clusters (n=13 304). One primary health-care centre withdrew from the study due to restricted capacity to participate. We detected no difference in the relative prevalence of STIs between intervention and control clusters (adjusted relative risk [RR] 0·97, 95% CI 0·84-1·12; p=0·66). However, testing coverage was substantially higher in intervention clusters (22%) than in control clusters (16%; RR 1·38; 95% CI 1·15-1·65; p=0·0006).
INTERPRETATION


Our intervention increased STI testing coverage but did not have an effect on prevalence. Additional interventions that will provide increased access to both testing and treatment are required to reduce persistently high prevalences of STIs in remote communities.
FUNDING


Australian National Health and Medical Research Council.",2019,"Primary endpoints were community prevalence and testing coverage in residents aged 16-34 years for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.","['recruited primary health-care centres serving Aboriginal communities in remote areas of Australia', 'Between April, 2010, and April, 2011, we recruited 68 primary care centres and grouped them into 24 clusters, which were randomly assigned into year 1 clusters (estimated population aged 16-34 years, n=11\u2008286), year 2 clusters (n=10\u2008288), or year 3 clusters (n=13\u2008304', 'Communities were eligible to participate if they were classified as very remote, had a population predominantly of Aboriginal people, and only had one primary health-care centre serving the population', 'remote Australian Aboriginal communities']",[],"['community prevalence and testing coverage in residents aged 16-34 years for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis', 'STI testing coverage', 'relative prevalence of STIs']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332286', 'cui_str': 'Into (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008151', 'cui_str': 'Chlamydia trachomatis'}, {'cui': 'C0027573', 'cui_str': 'Gonococcus'}, {'cui': 'C0040922', 'cui_str': 'Trichomonas vaginalis'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}]",68.0,0.145662,"Primary endpoints were community prevalence and testing coverage in residents aged 16-34 years for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ward', 'Affiliation': 'South Australian Health and Medical Research Institute, Adelaide, SA, Australia; Flinders University, Adelaide, SA, Australia. Electronic address: james.ward@sahmri.com.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Guy', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Alice R', 'Initials': 'AR', 'LastName': 'Rumbold', 'Affiliation': 'South Australian Health and Medical Research Institute, Adelaide, SA, Australia; Samson Institute, Adelaide University, Adelaide, SA, Australia; Menzies School of Health Research, Darwin, NT, Australia.'}, {'ForeName': 'Skye', 'Initials': 'S', 'LastName': 'McGregor', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Handan', 'Initials': 'H', 'LastName': 'Wand', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Hamish', 'Initials': 'H', 'LastName': 'McManus', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Amalie', 'Initials': 'A', 'LastName': 'Dyda', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia; Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Garton', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia; Northern Territory Department of Health, Darwin, NT, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Hengel', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia; Apunipima Cape York Health Council, Cairns, QLD, Australia.'}, {'ForeName': 'Bronwyn J', 'Initials': 'BJ', 'LastName': 'Silver', 'Affiliation': 'Central Australian Aboriginal Congress, Alice Springs, NT, Australia.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Taylor-Thomson', 'Affiliation': 'Menzies School of Health Research, Darwin, NT, Australia.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Knox', 'Affiliation': 'South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'Basil', 'Initials': 'B', 'LastName': 'Donovan', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia; Sydney Sexual Health Centre, Sydney, NSW, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Law', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Maher', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Fairley', 'Affiliation': 'Melbourne Sexual Health Centre, Melbourne, VIC, Australia; Central Clinical School Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Skov', 'Affiliation': 'Northern Territory Department of Health, Darwin, NT, Australia.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Ryder', 'Affiliation': 'Northern Territory Department of Health, Darwin, NT, Australia; Hunter New England Health Service, Newcastle, NSW, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Moore', 'Affiliation': 'Aboriginal Medical Services Alliance, Darwin, NT, Australia.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Mein', 'Affiliation': 'Wuchopperen Aboriginal Health Service, Cairns, QLD, Australia.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Reeve', 'Affiliation': 'James Cook University, Cairns, QLD, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Ah Chee', 'Affiliation': 'Central Australian Aboriginal Congress, Alice Springs, NT, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Boffa', 'Affiliation': 'Central Australian Aboriginal Congress, Alice Springs, NT, Australia.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kaldor', 'Affiliation': 'Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Global health,['10.1016/S2214-109X(19)30411-5']
1473,29154794,The relative persuasiveness of narrative versus non-narrative health messages in public health emergency communication: Evidence from a field experiment.,"Previous studies indicated that narrative health messages are more effective than non-narrative messages in influencing health outcomes. However, this body of evidence does not account for differences in health domain, and little is known about the effectiveness of this message execution strategy during public health emergencies. In this study, we examined the relative effectiveness of the two formats in influencing knowledge and perceived response efficacy related to prevention of pandemic influenza, and determined whether effects of message format vary across population sub-groups. Data for the study come from an experiment fielded in 2013 that involved a nationally representative sample of 627 American adults. Participants were randomly assigned to view either a narrative (n=322) or a non-narrative (n=305) video clip containing closely matched information about knowledge and preventive actions related to pandemic influenza, and completed pre- and post-viewing questions assessing knowledge and perceived response efficacy related to the prevention of pandemic influenza. Results indicated that participants in the non-narrative condition reported greater knowledge and rated pandemic influenza prevention measures as more effective compared with those in the narrative condition. Message format effects did not vary across population sub-groups; post-viewing scores of knowledge and perceptions related to pandemic influenza were consistently higher in the non-narrative condition compared with the narrative condition across five socio-demographic groups: age, gender, education, race/ethnicity and income. We concluded that didactic, non-narrative messages may be more effective than narrative messages to influence knowledge and perceptions during public health emergencies.",2018,"Message format effects did not vary across population sub-groups; post-viewing scores of knowledge and perceptions related to pandemic influenza were consistently higher in the non-narrative condition compared with the narrative condition across five socio-demographic groups: age, gender, education, race/ethnicity and income.","['public health emergency communication', '2013 that involved a nationally representative sample of 627 American adults']","['narrative (n=322) or a non-narrative (n=305) video clip containing closely matched information about knowledge and preventive actions related to pandemic influenza, and completed pre- and post-viewing questions assessing knowledge', 'narrative versus non-narrative health messages']",['knowledge and rated pandemic influenza prevention measures'],"[{'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",627.0,0.0673101,"Message format effects did not vary across population sub-groups; post-viewing scores of knowledge and perceptions related to pandemic influenza were consistently higher in the non-narrative condition compared with the narrative condition across five socio-demographic groups: age, gender, education, race/ethnicity and income.","[{'ForeName': 'Mesfin A', 'Initials': 'MA', 'LastName': 'Bekalu', 'Affiliation': 'Harvard T.H. Chan School of Public Health, 450 Brookline Avenue, LW 601, Boston, MA 02215, United States. Electronic address: bekalu@hsph.harvard.edu.'}, {'ForeName': 'Cabral A', 'Initials': 'CA', 'LastName': 'Bigman', 'Affiliation': 'Department of Communication, University of Illinois at Urbana-Champaign, USA.'}, {'ForeName': 'Rachel F', 'Initials': 'RF', 'LastName': 'McCloud', 'Affiliation': 'Harvard T.H. Chan School of Public Health, 450 Brookline Avenue, LW 601, Boston, MA 02215, United States.'}, {'ForeName': 'Leesa K', 'Initials': 'LK', 'LastName': 'Lin', 'Affiliation': 'Harvard T.H. Chan School of Public Health, 450 Brookline Avenue, LW 601, Boston, MA 02215, United States.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Viswanath', 'Affiliation': 'Harvard T.H. Chan School of Public Health, 450 Brookline Avenue, LW 601, Boston, MA 02215, United States.'}]",Preventive medicine,['10.1016/j.ypmed.2017.11.014']
1474,31476260,Percutaneous repair or medical treatment for secondary mitral regurgitation: outcomes at 2 years.,"AIMS


The MITRA-FR trial showed that among symptomatic patients with severe secondary mitral regurgitation, percutaneous repair did not reduce the risk of death or hospitalization for heart failure at 12 months compared with guideline-directed medical treatment alone. We report the 24-month outcome from this trial.
METHODS AND RESULTS


At 37 centres, we randomly assigned 304 symptomatic heart failure patients with severe secondary mitral regurgitation (effective regurgitant orifice area >20 mm 2  or regurgitant volume >30 mL), and left ventricular ejection fraction between 15% and 40% to undergo percutaneous valve repair plus medical treatment (intervention group, n = 152) or medical treatment alone (control group, n = 152). The primary efficacy outcome was the composite of all-cause death and unplanned hospitalization for heart failure at 12 months. At 24 months, all-cause death and unplanned hospitalization for heart failure occurred in 63.8% of patients (97/152) in the intervention group and 67.1% (102/152) in the control group [hazard ratio (HR) 1.01, 95% confidence interval (CI) 0.77-1.34]. All-cause mortality occurred in 34.9% of patients (53/152) in the intervention group and 34.2% (52/152) in the control group (HR 1.02, 95% CI 0.70-1.50). Unplanned hospitalization for heart failure occurred in 55.9% of patients (85/152) in the intervention group and 61.8% (94/152) in the control group (HR 0.97, 95% CI 0.72-1.30).
CONCLUSIONS


In patients with severe secondary mitral regurgitation, percutaneous repair added to medical treatment did not significantly reduce the risk of death or hospitalization for heart failure at 2 years compared with medical treatment alone.",2019,"All-cause mortality occurred in 34.9% of patients (53/152) in the intervention group and 34.2% (52/152) in the control group (hazard ratio, 1.02; 95% CI, 0.70 to 1.50).","['patients with severe secondary mitral regurgitation', 'group, n=152', 'symptomatic patients with severe secondary mitral regurgitation, percutaneous repair', '304 symptomatic heart failure patients with severe secondary mitral regurgitation (effective regurgitant orifice area >20\u2009mm 2  or regurgitant volume >30 mL), and left ventricular ejection fraction between 15% and 40% to undergo']","['percutaneous valve repair plus medical treatment (intervention group, n=152) or medical treatment alone (control', 'Percutaneous Repair or Medical Treatment']","['cause death and unplanned hospitalization for heart failure', 'risk of death or hospitalization for heart failure', 'All-cause mortality', 'composite of all-cause death and unplanned hospitalization for heart failure', 'Unplanned hospitalization for heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0026266', 'cui_str': 'Mitral Incompetence'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",304.0,0.156814,"All-cause mortality occurred in 34.9% of patients (53/152) in the intervention group and 34.2% (52/152) in the control group (hazard ratio, 1.02; 95% CI, 0.70 to 1.50).","[{'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Iung', 'Affiliation': 'Université de Paris and INSERM 1148, Paris, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Armoiry', 'Affiliation': 'Pharmacy Department and Laboratoire MATEIS, Hospices Civils de Lyon and Claude Bernard University, Lyon, France.'}, {'ForeName': 'Alec', 'Initials': 'A', 'LastName': 'Vahanian', 'Affiliation': 'APHP, Hôpital Bichat, DHU FIRE, Paris, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Boutitie', 'Affiliation': 'Lyon, France; Université Lyon 1, Villeurbanne, France; CNRS, UMR5558, Laboratoire de Biométrie et Biologie Évolutive, Équipe Biostatistique-Santé, Service de Biostatistique - Bioinformatique, Pôle Santé Publique, Hospices Civils de Lyon, Villeurbanne, France.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Mewton', 'Affiliation': 'Hopital Cardiovasculaire Louis Pradel, Clinical Investigation Center & Heart Failure Department, INSERM 1407, Hospices Civils de Lyon and Claude Bernard University, Lyon, France.'}, {'ForeName': 'Jean-Noël', 'Initials': 'JN', 'LastName': 'Trochu', 'Affiliation': 'CHU Nantes, INSERM, Nantes Université, Clinique Cardiologique et des Maladies Vasculaires, CIC 1413, Institut du Thorax, Nantes, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lefèvre', 'Affiliation': 'Institut Jacques Cartier, Massy, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Messika-Zeitoun', 'Affiliation': 'Université de Paris and INSERM 1148, Paris, France.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Guerin', 'Affiliation': 'CHU Nantes, INSERM, Nantes Université, Clinique Cardiologique et des Maladies Vasculaires, CIC 1413, Institut du Thorax, Nantes, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Cormier', 'Affiliation': 'Institut Jacques Cartier, Massy, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Brochet', 'Affiliation': 'Université de Paris and INSERM 1148, Paris, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Thibault', 'Affiliation': 'Hôpital Cardiovasculaire Louis Pradel, Service des Explorations Fonctionnelles Cardiovasculaires, Hospices Civils de Lyon and Claude Bernard University, Lyon, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Himbert', 'Affiliation': 'Université de Paris and INSERM 1148, Paris, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Thivolet', 'Affiliation': 'Hôpital Cardiovasculaire Louis Pradel, Service des Explorations Fonctionnelles Cardiovasculaires, Hospices Civils de Lyon and Claude Bernard University, Lyon, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Leurent', 'Affiliation': 'CHU Rennes, Hôpital Pontchaillou, Rennes, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Bonnet', 'Affiliation': 'APHM, Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Erwan', 'Initials': 'E', 'LastName': 'Donal', 'Affiliation': 'CHU Rennes, Hôpital Pontchaillou, Rennes, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Piriou', 'Affiliation': 'CHU Nantes, INSERM, Nantes Université, Clinique Cardiologique et des Maladies Vasculaires, CIC 1413, Institut du Thorax, Nantes, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Piot', 'Affiliation': 'Clinique du Millénaire, Montpellier, France.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Habib', 'Affiliation': 'APHM, Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Rouleau', 'Affiliation': 'CHU Angers, Angers, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Carrié', 'Affiliation': 'CHU Toulouse, Hôpital Rangueil, Toulouse, France.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Nejjari', 'Affiliation': 'Centre Cardiologique du Nord, Saint-Denis, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Ohlmann', 'Affiliation': 'Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Strasbourg, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Saint Etienne', 'Affiliation': 'CHRU de Tours, Hôpital Trousseau, Tours, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Leroux', 'Affiliation': 'CHU Bordeaux, Hôpital Haut-Lévêque, Pessac, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Gilard', 'Affiliation': 'CHRU Brest, Hôpital de La Cavale Blanche, Brest, France.'}, {'ForeName': 'Géraldine', 'Initials': 'G', 'LastName': 'Samson', 'Affiliation': 'Hopital Cardiovasculaire Louis Pradel, Clinical Investigation Center & Heart Failure Department, INSERM 1407, Hospices Civils de Lyon and Claude Bernard University, Lyon, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Rioufol', 'Affiliation': ""Hopital Cardiovasculaire Louis Pradel, Service d'Hémodynamique et Cardiologie Interventionnelle, Hospices Civils de Lyon and Claude Bernard University, Lyon, France.""}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Maucort-Boulch', 'Affiliation': 'Lyon, France; Université Lyon 1, Villeurbanne, France; CNRS, UMR5558, Laboratoire de Biométrie et Biologie Évolutive, Équipe Biostatistique-Santé, Service de Biostatistique - Bioinformatique, Pôle Santé Publique, Hospices Civils de Lyon, Villeurbanne, France.'}, {'ForeName': 'Jean François', 'Initials': 'JF', 'LastName': 'Obadia', 'Affiliation': 'Hopital Cardiovasculaire Louis Pradel, Chirurgie Cardio-Vasculaire et Transplantation Cardiaque, Hospices Civils de Lyon and Claude Bernard University, Lyon, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1616']
1475,31600474,The Impact of Dose and Dose Frequency on Word Learning by Kindergarten Children With Developmental Language Disorder During Interactive Book Reading.,"Purpose The goal was to determine whether interactive book reading outcomes for children with developmental language disorder (DLD) were affected by manipulation of dose (i.e., the number of exposures to the target word during a book reading session) and dose frequency (i.e., the number of repeated book reading sessions) and whether pretreatment factors predicted treatment response variation. Method Thirty-four kindergarten children with DLD (aged 5;0-6;2 [years;months]) were taught 1 set of words using the Dose 6 and Dose Frequency 6 format from a prior study (Storkel, Voelmle, et al., 2017) and taught a different set of words using an alternative format, either Dose 4 × Dose Frequency 9 or Dose 9 × Dose Frequency 4, determined through random assignment. Word learning was tracked for each treatment via a definition task prior to, during, and after treatment. Results Results showed that children with DLD learned a significant number of words during treatment regardless of the dose and dose frequency format but that significant forgetting of newly learned words occurred in all formats once treatment was withdrawn. Individual differences in word learning were related to Clinical Evaluation of Language Fundamentals Core Language and Understanding Spoken Paragraphs scores. Conclusion When administered at an adequate intensity, variation in the dose and dose frequency of interactive book reading does not appear to influence word learning by children with DLD. Although interactive book reading continues to show promise as an effective word learning intervention for children with DLD, further development is needed to enhance the effectiveness of this treatment approach. Supplemental Material https://doi.org/10.23641/asha.9745181.",2019,Results Results showed that children with DLD learned a significant number of words during treatment regardless of the dose and dose frequency format but that significant forgetting of newly learned words occurred in all formats once treatment was withdrawn.,"['Method Thirty-four kindergarten children with DLD (aged 5;0-6;2 [years;months', 'children with DLD', 'Kindergarten Children', 'children with developmental language disorder (DLD', 'With Developmental Language Disorder']",[],"['Clinical Evaluation of Language Fundamentals Core Language and Understanding Spoken Paragraphs scores', 'Word learning']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023014', 'cui_str': 'Speech or Language, Developmental Disorder'}]",[],"[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0397097,Results Results showed that children with DLD learned a significant number of words during treatment regardless of the dose and dose frequency format but that significant forgetting of newly learned words occurred in all formats once treatment was withdrawn.,"[{'ForeName': 'Holly L', 'Initials': 'HL', 'LastName': 'Storkel', 'Affiliation': 'Department of Speech-Language-Hearing: Sciences & Disorders, University of Kansas, Lawrence.'}, {'ForeName': 'Rouzana', 'Initials': 'R', 'LastName': 'Komesidou', 'Affiliation': 'Department of Speech-Language-Hearing: Sciences & Disorders, University of Kansas, Lawrence.'}, {'ForeName': 'Mollee J', 'Initials': 'MJ', 'LastName': 'Pezold', 'Affiliation': 'Department of Speech-Language-Hearing: Sciences & Disorders, University of Kansas, Lawrence.'}, {'ForeName': 'Adrienne R', 'Initials': 'AR', 'LastName': 'Pitt', 'Affiliation': 'Department of Speech-Language-Hearing: Sciences & Disorders, University of Kansas, Lawrence.'}, {'ForeName': 'Kandace K', 'Initials': 'KK', 'LastName': 'Fleming', 'Affiliation': 'Life Span Institute, University of Kansas, Lawrence.'}, {'ForeName': 'Rebecca Swinburne', 'Initials': 'RS', 'LastName': 'Romine', 'Affiliation': 'Life Span Institute, University of Kansas, Lawrence.'}]","Language, speech, and hearing services in schools",['10.1044/2019_LSHSS-VOIA-18-0131']
1476,31492643,Cognitive behavioural therapy for irritable bowel syndrome: 24-month follow-up of participants in the ACTIB randomised trial.,"BACKGROUND


Irritable bowel syndrome (IBS) is common, affecting 10-20% of the adult population worldwide, with many people reporting ongoing symptoms despite first-line therapies. Cognitive behavioural therapy (CBT) is recommended in guidelines for refractory IBS but there is insufficient access to CBT for IBS and uncertainty about whether benefits last in the longer term. Assessing Cognitive behavioural Therapy for IBS (ACTIB) was a large, randomised, controlled trial of two forms of CBT for patients with refractory IBS. ACTIB results showed that, at 12 months, both forms of CBT for IBS were significantly more effective than treatment as usual at reducing IBS symptom severity in adults with refractory IBS. This follow-up study aimed to evaluate 24-month clinical outcomes of participants in the ACTIB trial.
METHODS


In the ACTIB three-group, randomised, controlled trial, 558 adults with refractory IBS were randomly allocated to receive either therapist-delivered telephone CBT (telephone-CBT group), web-based CBT with minimal therapist support (web-CBT group), or treatment as usual (TAU group) and were followed up for 12 months. Participants were adults with refractory IBS (clinically significant symptoms for ≥12 months despite being offered first-line therapies), recruited by letter and opportunistically from 74 general practices and three gastroenterology centres in London and the south of England (UK) between May 1, 2014, and March 31, 2016. Primary outcome measures were IBS Symptom Severity Score (IBS-SSS) and Work and Social Adjustment Scale (WSAS), assessed in the intention-to-treat (ITT) population with multiple imputation. This study was a non-prespecified naturalistic follow-up and analysis of the participants of the ACTIB trial at 24 months assessing the same outcomes as the original trial. Outcome measures were completed online by participants or a paper questionnaire was posted, or telephone follow-up undertaken. The ACTIB trial is registered with the International Standard Randomised Controlled Trial Number registry, number ISRCTN44427879.
FINDINGS


24-month follow-up of outcomes was achieved for 323 (58%) of 558 participants: 119 (64%) of 186 in the telephone-CBT group, 99 (54%) of 185 in the web-CBT group, and 105 (56%) of 187 in the TAU group. At 24 months, mean IBS-SSS was 40·5 points (95% CI 15·0 to 66·0; p=0·002) lower in the telephone-CBT group and 12·9 points (-12·9 to 38·8; p=0·33) lower in the web-CBT group than in the TAU group. The mean WSAS score was 3·1 points (1·3 to 4·9; p<0·001) lower in the telephone-CBT group and 1·9 points (0·1 to 3·7; p=0·036) lower in the web-CBT group than in the TAU group. A clinically significant IBS-SSS change (≥50 points) from baseline to 24 months was found in 84 (71%) of 119 participants in the telephone-CBT group, in 62 (63%) of 99 in the web-CBT group, and in 48 (46%) of 105 in the TAU group. In total 41 adverse events were reported between 12 to 24 months: 11 in the telephone-CBT group, 15 in the web-CBT group, and 15 in the TAU group. Of these, eight were reported as gastrointestinal related, five as psychological, and six as musculoskeletal. There were no adverse events related to treatment.
INTERPRETATION


At 24-month follow-up, sustained improvements in IBS were seen in both CBT groups compared with TAU, although some previous gains were reduced compared with the 12-month outcomes. IBS-specific CBT has the potential to provide long-term improvement in IBS, achievable within a usual clinical setting. Increasing access to CBT for IBS could achieve long-term patient benefit.
FUNDING


UK National Institute for Health Research.",2019,"At 24-month follow-up, sustained improvements in IBS were seen in both CBT groups compared with TAU, although some previous gains were reduced compared with the 12-month outcomes.","['irritable bowel syndrome', 'Participants were adults with refractory IBS (clinically significant symptoms for ≥12 months despite being offered first-line therapies), recruited by letter and opportunistically from 74 general practices and three gastroenterology centres in London and the south of England (UK) between May 1, 2014, and March 31, 2016', 'adults with refractory IBS', '558 adults with refractory IBS', 'participants in the ACTIB trial', 'patients with refractory IBS']","['Cognitive behavioural therapy', 'Cognitive behavioural therapy (CBT', 'therapist-delivered telephone CBT (telephone-CBT group), web-based CBT with minimal therapist support (web-CBT group), or treatment as usual (TAU group', 'CBT']","['IBS symptom severity', 'mean IBS-SSS', 'mean WSAS score', 'IBS Symptom Severity Score (IBS-SSS) and Work and Social Adjustment Scale (WSAS), assessed in the intention-to-treat (ITT) population with multiple imputation', 'IBS', 'IBS-SSS change']","[{'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0017163', 'cui_str': 'Gastroenterology'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0451485', 'cui_str': 'Social adjustment scale (assessment scale)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",558.0,0.1374,"At 24-month follow-up, sustained improvements in IBS were seen in both CBT groups compared with TAU, although some previous gains were reduced compared with the 12-month outcomes.","[{'ForeName': 'Hazel A', 'Initials': 'HA', 'LastName': 'Everitt', 'Affiliation': 'School of Primary Care Population Sciences and Medical Education, University of Southampton, Southampton, UK. Electronic address: hae1@soton.ac.uk.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Landau', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Gilly', 'Initials': 'G', 'LastName': ""O'Reilly"", 'Affiliation': 'School of Primary Care Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Sibelli', 'Affiliation': ""Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Hughes', 'Affiliation': 'School of Primary Care Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Sula', 'Initials': 'S', 'LastName': 'Windgassen', 'Affiliation': ""Academic Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Holland', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'School of Primary Care Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""King's Health Economics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Felicity L', 'Initials': 'FL', 'LastName': 'Bishop', 'Affiliation': 'Centre for Applications of Health Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Goldsmith', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Coleman', 'Affiliation': 'Department of Gastroenterology, Southampton University Hospital, Southampton, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Logan', 'Affiliation': ""King's College Hospital, London, UK.""}, {'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""Academic Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Moss-Morris', 'Affiliation': ""Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30243-2']
1477,31397714,Antibiotic Exposure Profiles in Trials Comparing Intensity of Continuous Renal Replacement Therapy.,"OBJECTIVES


To determine whether the probability of target attainment over 72 hours of initial therapy with beta-lactam (cefepime, ceftazidime, piperacillin/tazobactam) and carbapenem (imipenem, meropenem) antibiotics were substantially influenced between intensive and less-intensive continuous renal replacement therapy groups in the Acute Renal Failure Trial Network trial and The RENAL Replacement Therapy Study trial.
DESIGN


The probability of target attainment was calculated using pharmacodynamic targets of percentage of time that free serum concentrations (fT): 1) were above the target organism's minimum inhibitory concentration (≥ fT > 1 × minimum inhibitory concentration); 2) were above four times the minimum inhibitory concentration (≥ % fT > 4 × minimum inhibitory concentration); and 3) were always above the minimum inhibitory concentration (≥ 100% fT > minimum inhibitory concentration) for the first 72 hours of antibiotic therapy. Demographic data and effluent rates from the Acute Renal Failure Trial Network and RENAL Replacement Therapy Study trials were used. Optimal doses were defined as the dose achieving greater than or equal to 90% probability of target attainment.
SETTING


Monte Carlo simulations using demographic data from Acute Renal Failure Trial Network and RENAL Replacement Therapy Study trials.
PATIENTS


Virtual critically ill patients requiring continuous renal replacement therapy.
INTERVENTIONS


None.
MEASUREMENTS AND MAIN RESULTS


The pharmacodynamic target of fT greater than 1 × minimum inhibitory concentration led to similarly high rates of predicted response with antibiotic doses often used in continuous renal replacement therapy. Achieving 100% fT greater than minimum inhibitory concentration is a more stringent benchmark compared with T greater than 4 × minimum inhibitory concentration with standard antibiotic dosing. The intensity of effluent flow rates (less intensive vs intensive) did not substantially influence the probability of target attainment of antibiotic dosing regimens regardless of pharmacodynamic target.
CONCLUSIONS


Antibiotic pharmacodynamic target attainment rates likely were not meaningfully different in the low- and high-intensity treatment arms of the Acute Renal Failure Trial Network and RENAL Replacement Therapy Study Investigators trials.",2019,"The intensity of effluent flow rates (less intensive vs intensive) did not substantially influence the probability of target attainment of antibiotic dosing regimens regardless of pharmacodynamic target.
",['Virtual critically ill patients requiring continuous renal replacement therapy'],"['Continuous Renal Replacement Therapy', 'beta-lactam (cefepime, ceftazidime, piperacillin/tazobactam) and carbapenem (imipenem, meropenem) antibiotics']",['intensity of effluent flow rates'],"[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy (procedure)'}]","[{'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy (procedure)'}, {'cui': 'C0282215', 'cui_str': 'beta-Lactams'}, {'cui': 'C0055003', 'cui_str': 'cefepime'}, {'cui': 'C0007559', 'cui_str': 'Ceftazidime'}, {'cui': 'C0250480', 'cui_str': 'Piperacillin / tazobactam'}, {'cui': 'C0006968', 'cui_str': 'Antibiotics, Carbapenem'}, {'cui': 'C0020933', 'cui_str': 'Imipenem'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}]",,0.0651326,"The intensity of effluent flow rates (less intensive vs intensive) did not substantially influence the probability of target attainment of antibiotic dosing regimens regardless of pharmacodynamic target.
","[{'ForeName': 'Soo Min', 'Initials': 'SM', 'LastName': 'Jang', 'Affiliation': 'Department of Pharmacy Practice, Loma Linda University School of Pharmacy, Loma Linda, CA.'}, {'ForeName': 'Manjunath P', 'Initials': 'MP', 'LastName': 'Pai', 'Affiliation': 'Department of Clinical Pharmacy, University of Michigan College of Pharmacy, Ann Arbor, MI.'}, {'ForeName': 'Alexander R', 'Initials': 'AR', 'LastName': 'Shaw', 'Affiliation': 'Medical Affairs, Alkermes, Waltham, MA.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Mueller', 'Affiliation': 'Department of Clinical Pharmacy, University of Michigan College of Pharmacy, Ann Arbor, MI.'}]",Critical care medicine,['10.1097/CCM.0000000000003955']
1478,32412387,The cost effectiveness of pembrolizumab versus chemotherapy or atezolizumab as second-line therapy for advanced urothelial carcinoma in the United States.,"AIMS:  Pembrolizumab demonstrated significantly prolonged overall survival (OS) vs. chemotherapy in the Phase III KEYNOTE-045 trial, and is approved in the US for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who progressed after platinum-based chemotherapy. Using longer follow-up and individual patient-data from KEYNOTE-045, this study evaluates the cost-effectiveness of pembrolizumab vs. chemotherapy or atezolizumab from a US payer perspective. MATERIALS AND METHODS:  A partitioned-survival model was developed over a 20-year time horizon. Progression-free survival (PFS) and OS for pembrolizumab and chemotherapy were extrapolated using a piecewise modelling approach, where patient-level data from KEYNOTE-045 were used for the initial period followed by parametric distributions. OS of atezolizumab was estimated by indirect treatment comparisons based on KEYNOTE-045 and IMvigor211. Different scenarios were explored in the absence of indirect comparisons on PFS and time-on-treatment (ToT) between pembrolizumab and atezolizumab. Drug acquisition/administration, disease management, adverse events and terminal care costs were considered. RESULTS:  Compared with chemotherapy, pembrolizumab resulted in a mean gain of 1.33 life-years and 1.14 quality-adjusted life-years (QALYs) and an incremental cost of $106,299, yielding an incremental cost-effectiveness ratio of $93,481/QALY gained. Pembrolizumab dominated atezolizumab in extending patients' life by 0.89 years and 0.76 QALYs, while reducing costs by $26,458. Key drivers of cost-effectiveness included survival extrapolation, OS hazard ratio of pembrolizumab vs. atezolizumab and time horizon. Pembrolizumab had a 66% and 100% probability of being cost-effective vs. chemotherapy and atezolizumab, respectively, at a $100,000 willingness-to-pay threshold. LIMITATIONS AND CONCLUSIONS:  Uncertainties remain with extrapolated PFS and OS for pembrolizumab, OS indirect comparison and ToT for atezolizumab. Despite these limitations, the model used robust methods to estimate key clinical endpoints with patient-level data from longer follow-up of KEYNOTE-045. Pembrolizumab dominates atezolizumab and is very likely cost-effective vs. chemotherapy in 2L mUC at a $100,000 willingness-to-pay threshold.",2020,"Pembrolizumab had a 66% and 100% probability of being cost-effective vs. chemotherapy and atezolizumab, respectively, at a $100,000 willingness-to-pay threshold.","['patients with locally advanced or metastatic urothelial carcinoma (mUC) who progressed after platinum-based chemotherapy', 'advanced urothelial carcinoma in the United States']","['atezolizumab', 'Pembrolizumab dominated atezolizumab', 'pembrolizumab versus chemotherapy or atezolizumab', 'Pembrolizumab', 'pembrolizumab vs. chemotherapy or atezolizumab', 'chemotherapy, pembrolizumab']","['survival extrapolation, OS hazard ratio of pembrolizumab vs. atezolizumab and time horizon', 'Progression-free survival (PFS) and OS', 'incremental cost-effectiveness ratio', 'Drug acquisition/administration, disease management, adverse events and terminal care costs', 'cost effectiveness', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039548', 'cui_str': 'Terminal care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0711215,"Pembrolizumab had a 66% and 100% probability of being cost-effective vs. chemotherapy and atezolizumab, respectively, at a $100,000 willingness-to-pay threshold.","[{'ForeName': 'Rachael Louise', 'Initials': 'RL', 'LastName': 'Slater', 'Affiliation': 'BresMed Health Solutions Ltd, Sheffield, UK.'}, {'ForeName': 'Yizhen', 'Initials': 'Y', 'LastName': 'Lai', 'Affiliation': 'Merck & Co, Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Yichen', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': 'Merck & Co, Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Haojie', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Merck & Co, Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Meng', 'Affiliation': 'BresMed Health Solutions Ltd, Sheffield, UK.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Homet Moreno', 'Affiliation': 'Merck & Co, Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'James Luke', 'Initials': 'JL', 'LastName': 'Godwin', 'Affiliation': 'Merck & Co, Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Frenkl', 'Affiliation': 'Merck & Co, Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Guru P', 'Initials': 'GP', 'LastName': 'Sonpavde', 'Affiliation': 'Dana-Farber Cancer Institute, MA, USA.'}, {'ForeName': 'Ronac', 'Initials': 'R', 'LastName': 'Mamtani', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.'}]",Journal of medical economics,['10.1080/13696998.2020.1770261']
1479,32412388,The factor structure of the Working Alliance Inventory short-form in youth psychotherapy: an empirical investigation.,"Objective:  The Working Alliance Inventory short form (WAI-S) is one of the most commonly used alliance measures with adolescents. Yet, its factor structure has received minimal attention in the youth alliance literature. This study investigated the factor structure of the WAI-S in psychotherapy for adolescent depression and explored its measurement invariance across time, therapeutic approaches and patients' and therapists' perspectives. The existence of method effects associated with the negatively worded items of the scale was also assessed. Method:  The setting of this study is the IMPACT trial, a randomized controlled trial assessing the effects of three therapeutic interventions in the treatment of adolescent depression. The WAI-S was completed at 6, 12 and 36 weeks after randomization by 338 adolescents and 159 therapists. Data were analysed using confirmatory factor analysis. Results:  The hypothesized Bond-Task-Goal alliance structure was not supported and a general, one-factor model was found to be more psychometrically valid. The existence of a method effect and measurement invariance across time and treatment arms were also found. Conclusions:  While the distinction between the specific alliance dimensions is conceptually and clinically interesting, at an empirical level the alliance features of the WAI-S in youth psychotherapy remain strongly intercorrelated.",2020,"The hypothesized Bond-Task-Goal alliance structure was not supported and a general, one-factor model was found to be more psychometrically valid.","['338 adolescents and 159 therapists', 'adolescent depression', 'youth psychotherapy']",['Working Alliance Inventory short form (WAI-S'],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",[],338.0,0.071215,"The hypothesized Bond-Task-Goal alliance structure was not supported and a general, one-factor model was found to be more psychometrically valid.","[{'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Cirasola', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Midgley', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fonagy', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Impact', 'Initials': 'I', 'LastName': 'Consortium', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': 'Child Attachment and Psychological Therapies Research Unit (ChAPTRe), Anna Freud National Centre for Children and Families, London, UK.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2020.1765041']
1480,31663905,Development and Validation of a Nomogram for Early Detection of Malignant Gallbladder Lesions.,"OBJECTIVES


Preoperative decision-making for differentiating malignant from benign lesions in the gallbladder remains challenging. We aimed to create a diagnostic nomogram to identify gallbladder cancer (GBC), especially for incidental GBC (IGBC), before surgical resection.
METHODS


A total of 587 consecutive patients with pathologically confirmed gallbladder lesions from a hospital were randomly assigned to a training cohort (70%) and an internal validation cohort (30%), with 287 patients from other centers as an external validation cohort. Radiological features were developed by the least absolute shrinkage and selection operator logistic regression model. Significant radiological features and independent clinical factors, identified by multivariate analyses, were used to construct a nomogram.
RESULTS


A diagnostic nomogram was established by age, CA19.9, and 6 radiological features. The values of area under the curve in the internal and external validation cohorts were up to 0.91 and 0.89, respectively. The calibration curves for probability of GBC showed optimal agreement between nomogram prediction and actual observation. Compared with previous methods, it demonstrated superior sensitivity (91.5%) and accuracy (85.1%) in the diagnosis of GBC. The accuracy using the nomogram was significantly higher in GBC groups compared with that by radiologists in the training cohort (P < 0.001) and similarly in each cohort. Notably, most of the IGBC, which were misdiagnosed as benign lesions, were successfully identified using this nomogram.
DISCUSSION


A novel nomogram provides a powerful tool for detecting the presence of cancer in gallbladder masses, with an increase in accuracy and sensitivity. It demonstrates an unprecedented potential for IGBC identification.",2019,"A novel nomogram provides a powerful tool for detecting the presence of cancer in gallbladder masses, with an increase in accuracy and sensitivity.","['587 consecutive patients with pathologically confirmed gallbladder lesions from a hospital were randomly assigned to a training cohort (70%) and an internal validation cohort (30%), with 287 patients from other centers as an external validation cohort']",[],"['superior sensitivity', 'values of area under the curve']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C4517682', 'cui_str': '287 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}]",[],"[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",587.0,0.0274637,"A novel nomogram provides a powerful tool for detecting the presence of cancer in gallbladder masses, with an increase in accuracy and sensitivity.","[{'ForeName': 'Mingyu', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, Sir Run-Run Shaw Hospital, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jiasheng', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Department of General Surgery, Sir Run-Run Shaw Hospital, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of General Surgery, Jinhua Municipal Central Hospital, Jinhua, China.'}, {'ForeName': 'Chenhao', 'Initials': 'C', 'LastName': 'Tong', 'Affiliation': ""Department of General Surgery, Shaoxing People's Hospital, Zhejiang University, Shaoxing, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': ""Department of General Surgery, Longyou People's Hospital, Quzhou, China.""}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Jindal', 'Affiliation': 'Department of Internal Medicine, St. Vincent Hospital, Worcester, Massachusetts, USA.'}, {'ForeName': 'Leandro Cardoso', 'Initials': 'LC', 'LastName': 'Barchi', 'Affiliation': 'Digestive Surgery Division, Department of Gastroenterology, University of Sao Paulo School of Medicine, São Paulo, Brazil.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Nadalin', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, University Hospital Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Sherry X', 'Initials': 'SX', 'LastName': 'Yang', 'Affiliation': 'National Clinical Target Validation Laboratory, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pesce', 'Affiliation': 'Department of Medical and Surgical Sciences and Advanced Technologies ""G.F. Ingrassia"" Policlinico-Vittorio Emanuele Hospital, Unit of General Surgery, University of Catania, Catania, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Panaro', 'Affiliation': 'Division of Transplantation, Department of General Surgery, University of Montpellier-College of Medicine, Saint Eloi Hospital, Montpellier, France.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Ariche', 'Affiliation': 'Department of Surgery, Hadassah Medical Center, Mount Scopus, Jerusalem, Israel.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Kai', 'Affiliation': 'Department of Pathology, Saga University Hospital, Saga, Japan.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Memeo', 'Affiliation': 'Department of Emergency and Organ Transplantation, General Surgery and Transplantation, University Aldo Moro of Bari, Bari, Italy.'}, {'ForeName': 'Tanios', 'Initials': 'T', 'LastName': 'Bekaii-Saab', 'Affiliation': 'Medical Oncology, Mayo Clinic, Phoenix, Arizona, USA.'}, {'ForeName': 'Xiujun', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': 'Department of General Surgery, Sir Run-Run Shaw Hospital, Zhejiang University, Hangzhou, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000098']
1481,32411850,Ups and downs of a peer-based smoking cessation intervention help tailored to hospital-employees with low socioeconomic status: The RESPEKT Study.,"INTRODUCTION


Smoking is one of the most important determinants of socioeconomic inequality in mortality. Few studies have tested which interventions are effective in smokers with low socioeconomic status (SES).
METHODS


All hospitals in the Capital Region of Denmark were included and randomized to intervention or control groups. The target-group was smokers with low SES. Intervention hospitals: smokers in the target-group assisted researchers to tailor a group-based smoking cessation intervention. Further they helped recruiting smoking colleagues and motivating them to stay abstinent. Control hospitals: 'as usual'. Unforeseen organizational challenges led to a change of study design; the hospital-level assessment was reduced to two cross-sectional surveys.
RESULTS


Response rates in hospitals' smoking status survey were very low. Smoking status was reported by 1876 out of 7003 employees at baseline and 2280 out of 7496 employees at 1-year follow-up. Two cross-sectional surveys showed no significant difference in self-reported smoking at 1-year follow-up between intervention and control hospitals (p=0.262). We recruited 100 smokers in the group-based smoking cessation intervention tailored to smokers with low SES (corresponding to approx. 10% of smokers in target-group); 32.4% of these were validated as continuously abstinent at 6 months follow-up.
CONCLUSIONS


Involving smokers with low SES as partners at an early stage of study design facilitated both recruitment and development of the intervention. Despite high validated long-term abstinence rates in smoking cessation groups in the intervention hospitals we found no apparent effect of the intervention at hospital-level after one year. However, larger involvement of the target-group seems feasible and is recommended.",2018,Two cross-sectional surveys showed no significant difference in self-reported smoking at 1-year follow-up between intervention and control hospitals (p=0.262).,"['All hospitals in the Capital Region of Denmark', '1876 out of 7003 employees at baseline and 2280 out of 7496 employees at 1-year follow-up', '100 smokers in the group-based smoking cessation intervention tailored to smokers with low SES (corresponding to approx', 'hospital-employees with low socioeconomic status', 'smokers with low socioeconomic status (SES']","['Ups and downs of a peer-based smoking cessation intervention', 'target-group assisted researchers to tailor a group-based smoking cessation intervention']",[],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}]","[{'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]",[],7496.0,0.019698,Two cross-sectional surveys showed no significant difference in self-reported smoking at 1-year follow-up between intervention and control hospitals (p=0.262).,"[{'ForeName': 'Charlotta', 'Initials': 'C', 'LastName': 'Pisinger', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Maj-Britt Bjerre', 'Initials': 'MB', 'LastName': 'Koch', 'Affiliation': 'Rygestopkonsulenterne Aps.'}, {'ForeName': 'Else', 'Initials': 'E', 'LastName': 'Hjortsø', 'Affiliation': 'Capital Region of Denmark, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Jørgensen', 'Affiliation': 'Institute of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Glümer', 'Affiliation': 'Center for Diabetes, Copenhagen, Denmark.'}]",Tobacco prevention & cessation,['10.18332/tpc/91426']
1482,28969438,Adjunctive Bright Light Therapy for Bipolar Depression: A Randomized Double-Blind Placebo-Controlled Trial.,"OBJECTIVE


Patients with bipolar disorder have recurrent major depression, residual mood symptoms, and limited treatment options. Building on promising pilot data, the authors conducted a 6-week randomized double-blind placebo-controlled trial to investigate the efficacy of adjunctive bright light therapy at midday for bipolar depression. The aims were to determine remission rate, depression symptom level, and rate of mood polarity switch, as well as to explore sleep quality.
METHOD


The study enrolled depressed adults with bipolar I or II disorder who were receiving stable dosages of antimanic medication (excluding patients with hypomania or mania, mixed symptoms, or rapid cycling). Patients were randomly assigned to treatment with either 7,000-lux bright white light or 50-lux dim red placebo light (N=23 for each group). Symptoms were assessed weekly with the Structured Interview Guide for the Hamilton Depression Scale With Atypical Depression Supplement (SIGH-ADS), the Mania Rating Scale, and the Pittsburgh Sleep Quality Index. Remission was defined as having a SIGH-ADS score of 8 or less.
RESULTS


At baseline, both groups had moderate depression and no hypomanic or manic symptoms. Compared with the placebo light group, the group treated with bright white light experienced a significantly higher remission rate (68.2% compared with 22.2%; adjusted odds ratio=12.6) at weeks 4-6 and significantly lower depression scores (9.2 [SD=6.6] compared with 14.9 [SD=9.2]; adjusted β=-5.91) at the endpoint visit. No mood polarity switches were observed. Sleep quality improved in both groups and did not differ significantly between them.
CONCLUSIONS


The data from this study provide robust evidence that supports the efficacy of midday bright light therapy for bipolar depression.",2018,"Sleep quality improved in both groups and did not differ significantly between them.
","['enrolled depressed adults with bipolar I or II disorder who were receiving stable dosages of antimanic medication (excluding patients with hypomania or mania, mixed symptoms, or rapid cycling', 'Patients with bipolar disorder', 'Bipolar Depression']","['placebo', 'midday bright light therapy', 'Placebo', '7,000-lux bright white light or 50-lux dim red placebo light', 'Adjunctive Bright Light Therapy', 'adjunctive bright light therapy']","['remission rate', 'depression scores', 'Hamilton Depression Scale With Atypical Depression Supplement (SIGH-ADS), the Mania Rating Scale, and the Pittsburgh Sleep Quality Index', 'remission rate, depression symptom level, and rate of mood polarity switch', 'Sleep quality', 'moderate depression and no hypomanic or manic symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0242911', 'cui_str': 'Antimanic Drugs'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0241934', 'cui_str': 'Hypomanic mood (finding)'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0585020', 'cui_str': 'Noon (qualifier value)'}, {'cui': 'C0423899', 'cui_str': 'Gifted (observable entity)'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C0560137', 'cui_str': 'lux (qualifier value)'}, {'cui': 'C0563228', 'cui_str': 'White light (physical force)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0588007', 'cui_str': 'Moderate depression (disorder)'}]",,0.291731,"Sleep quality improved in both groups and did not differ significantly between them.
","[{'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Sit', 'Affiliation': 'From the Department of Psychiatry and Behavioral Sciences and the Department of Preventive Medicine-Biostatistics Division, Feinberg School of Medicine, Northwestern University, Chicago; the Department of Psychiatry, University of Pittsburgh School of Medicine and University of Pittsburgh Medical Center, Pittsburgh; the Epidemiological Data Center, Graduate School of Public Health, University of Pittsburgh, Pittsburgh; the Department of Statistics, Carnegie Mellon University, Pittsburgh; and the Department of Psychiatry, Columbia University and New York State Psychiatric Institute, New York.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McGowan', 'Affiliation': 'From the Department of Psychiatry and Behavioral Sciences and the Department of Preventive Medicine-Biostatistics Division, Feinberg School of Medicine, Northwestern University, Chicago; the Department of Psychiatry, University of Pittsburgh School of Medicine and University of Pittsburgh Medical Center, Pittsburgh; the Epidemiological Data Center, Graduate School of Public Health, University of Pittsburgh, Pittsburgh; the Department of Statistics, Carnegie Mellon University, Pittsburgh; and the Department of Psychiatry, Columbia University and New York State Psychiatric Institute, New York.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Wiltrout', 'Affiliation': 'From the Department of Psychiatry and Behavioral Sciences and the Department of Preventive Medicine-Biostatistics Division, Feinberg School of Medicine, Northwestern University, Chicago; the Department of Psychiatry, University of Pittsburgh School of Medicine and University of Pittsburgh Medical Center, Pittsburgh; the Epidemiological Data Center, Graduate School of Public Health, University of Pittsburgh, Pittsburgh; the Department of Statistics, Carnegie Mellon University, Pittsburgh; and the Department of Psychiatry, Columbia University and New York State Psychiatric Institute, New York.'}, {'ForeName': 'Rasim Somer', 'Initials': 'RS', 'LastName': 'Diler', 'Affiliation': 'From the Department of Psychiatry and Behavioral Sciences and the Department of Preventive Medicine-Biostatistics Division, Feinberg School of Medicine, Northwestern University, Chicago; the Department of Psychiatry, University of Pittsburgh School of Medicine and University of Pittsburgh Medical Center, Pittsburgh; the Epidemiological Data Center, Graduate School of Public Health, University of Pittsburgh, Pittsburgh; the Department of Statistics, Carnegie Mellon University, Pittsburgh; and the Department of Psychiatry, Columbia University and New York State Psychiatric Institute, New York.'}, {'ForeName': 'John Jesse', 'Initials': 'JJ', 'LastName': 'Dills', 'Affiliation': 'From the Department of Psychiatry and Behavioral Sciences and the Department of Preventive Medicine-Biostatistics Division, Feinberg School of Medicine, Northwestern University, Chicago; the Department of Psychiatry, University of Pittsburgh School of Medicine and University of Pittsburgh Medical Center, Pittsburgh; the Epidemiological Data Center, Graduate School of Public Health, University of Pittsburgh, Pittsburgh; the Department of Statistics, Carnegie Mellon University, Pittsburgh; and the Department of Psychiatry, Columbia University and New York State Psychiatric Institute, New York.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Luther', 'Affiliation': 'From the Department of Psychiatry and Behavioral Sciences and the Department of Preventive Medicine-Biostatistics Division, Feinberg School of Medicine, Northwestern University, Chicago; the Department of Psychiatry, University of Pittsburgh School of Medicine and University of Pittsburgh Medical Center, Pittsburgh; the Epidemiological Data Center, Graduate School of Public Health, University of Pittsburgh, Pittsburgh; the Department of Statistics, Carnegie Mellon University, Pittsburgh; and the Department of Psychiatry, Columbia University and New York State Psychiatric Institute, New York.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Yang', 'Affiliation': 'From the Department of Psychiatry and Behavioral Sciences and the Department of Preventive Medicine-Biostatistics Division, Feinberg School of Medicine, Northwestern University, Chicago; the Department of Psychiatry, University of Pittsburgh School of Medicine and University of Pittsburgh Medical Center, Pittsburgh; the Epidemiological Data Center, Graduate School of Public Health, University of Pittsburgh, Pittsburgh; the Department of Statistics, Carnegie Mellon University, Pittsburgh; and the Department of Psychiatry, Columbia University and New York State Psychiatric Institute, New York.'}, {'ForeName': 'Jody D', 'Initials': 'JD', 'LastName': 'Ciolino', 'Affiliation': 'From the Department of Psychiatry and Behavioral Sciences and the Department of Preventive Medicine-Biostatistics Division, Feinberg School of Medicine, Northwestern University, Chicago; the Department of Psychiatry, University of Pittsburgh School of Medicine and University of Pittsburgh Medical Center, Pittsburgh; the Epidemiological Data Center, Graduate School of Public Health, University of Pittsburgh, Pittsburgh; the Department of Statistics, Carnegie Mellon University, Pittsburgh; and the Department of Psychiatry, Columbia University and New York State Psychiatric Institute, New York.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Seltman', 'Affiliation': 'From the Department of Psychiatry and Behavioral Sciences and the Department of Preventive Medicine-Biostatistics Division, Feinberg School of Medicine, Northwestern University, Chicago; the Department of Psychiatry, University of Pittsburgh School of Medicine and University of Pittsburgh Medical Center, Pittsburgh; the Epidemiological Data Center, Graduate School of Public Health, University of Pittsburgh, Pittsburgh; the Department of Statistics, Carnegie Mellon University, Pittsburgh; and the Department of Psychiatry, Columbia University and New York State Psychiatric Institute, New York.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Wisniewski', 'Affiliation': 'From the Department of Psychiatry and Behavioral Sciences and the Department of Preventive Medicine-Biostatistics Division, Feinberg School of Medicine, Northwestern University, Chicago; the Department of Psychiatry, University of Pittsburgh School of Medicine and University of Pittsburgh Medical Center, Pittsburgh; the Epidemiological Data Center, Graduate School of Public Health, University of Pittsburgh, Pittsburgh; the Department of Statistics, Carnegie Mellon University, Pittsburgh; and the Department of Psychiatry, Columbia University and New York State Psychiatric Institute, New York.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Terman', 'Affiliation': 'From the Department of Psychiatry and Behavioral Sciences and the Department of Preventive Medicine-Biostatistics Division, Feinberg School of Medicine, Northwestern University, Chicago; the Department of Psychiatry, University of Pittsburgh School of Medicine and University of Pittsburgh Medical Center, Pittsburgh; the Epidemiological Data Center, Graduate School of Public Health, University of Pittsburgh, Pittsburgh; the Department of Statistics, Carnegie Mellon University, Pittsburgh; and the Department of Psychiatry, Columbia University and New York State Psychiatric Institute, New York.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Wisner', 'Affiliation': 'From the Department of Psychiatry and Behavioral Sciences and the Department of Preventive Medicine-Biostatistics Division, Feinberg School of Medicine, Northwestern University, Chicago; the Department of Psychiatry, University of Pittsburgh School of Medicine and University of Pittsburgh Medical Center, Pittsburgh; the Epidemiological Data Center, Graduate School of Public Health, University of Pittsburgh, Pittsburgh; the Department of Statistics, Carnegie Mellon University, Pittsburgh; and the Department of Psychiatry, Columbia University and New York State Psychiatric Institute, New York.'}]",The American journal of psychiatry,['10.1176/appi.ajp.2017.16101200']
1483,32411728,Computed Tomography Angiography in Peripheral Arterial Disease: Comparison of Three Image Acquisition Techniques to Optimize Vascular Enhancement-Randomized Controlled Trial.,"Objectives:  To prospectively compare three image acquisition techniques in lower extremity CT angiography: the ""standard"" anterograde technique (SA), the adaptive anterograde technique (AA), and the retrograde acquisition technique (RA).  Materials and Methods:  Sixty consecutive patients were prospectively enrolled and randomized into three acquisition groups: 20 patients were evaluated with SA, 20 with AA as described by Qanadli et al., and 20 with caudocranial acquisition from the feet to the abdominal aorta (RA). Quantitative image quality was assessed by measuring the intraluminal attenuation at different levels of interest, with a total of 536 levels. Qualitative image quality was assessed by two radiologists in consensus using a Likert scale to rate the arterial enhancement and venous return. For each patient and limb, the presence of occlusive or aneurysmal disease was documented.  Results:  In quantitative analysis, RA showed lower attenuation values than SA and AA ( p  < 0.01). AA showed the highest and most homogeneous attenuation along the arterial tree. In qualitative analysis, AA had the lowest rate of non-diagnostic vascular segments (3.9%) compared to SA and RA (4.7 and 13.1%, respectively,  p  < 0.01). The influence of venous return was significantly different among the different techniques; venous contamination was particularly prevalent at the aortic level with RA (9.4% of patients, 0% with SA and AA,  p  < 0.01). The presence of stenosis or occlusion had no significant influence on the attenuation values across all levels and acquisition techniques. Conversely, the presence of aneurysmal disease had a significant effect on the luminal attenuation in AA (higher attenuation) and RA (lower attenuation) at the iliac ( p  = 0.03 and 0.04, respectively) and femoral levels ( p  = 0.02 and <0.01, respectively).  Conclusion:  Considering both quantitative and qualitative analysis, AA performed better than SA and RA, providing the highest percentage of optimal vascular enhancement. AA should be recommended as the technique of choice, specifically in the presence of aneurysmal disease. Alternatively, SA can be useful in case of renal failure, as the test bolus is unnecessary. Finally, the increasing availability of fast CT systems will likely overcome the limitations of RA.",2020,"Considering both quantitative and qualitative analysis, AA performed better than SA and RA, providing the highest percentage of optimal vascular enhancement.","['Peripheral Arterial Disease', 'Sixty consecutive patients were prospectively enrolled and randomized into three acquisition groups: 20 patients were evaluated with SA, 20 with AA as described by Qanadli et al., and 20 with caudocranial acquisition from the feet to the abdominal aorta (RA']","['standard"" anterograde technique (SA', 'Computed Tomography Angiography']","['Quantitative image quality', 'femoral levels', 'venous return', 'lowest rate of non-diagnostic vascular segments', 'Qualitative image quality', 'luminal attenuation in AA']","[{'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003484', 'cui_str': 'Abdominal aorta structure'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0589502', 'cui_str': 'Antegrade direction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}]",60.0,0.040684,"Considering both quantitative and qualitative analysis, AA performed better than SA and RA, providing the highest percentage of optimal vascular enhancement.","[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Rotzinger', 'Affiliation': 'Cardiothoracic and Vascular Division, Department of Diagnostic and Interventional Radiology, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Tri-Linh', 'Initials': 'TL', 'LastName': 'Lu', 'Affiliation': 'Cardiothoracic and Vascular Division, Department of Diagnostic and Interventional Radiology, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Kawkabani', 'Affiliation': ""Groupement Hospitalier de L'Ouest Lémanique, Nyon, Switzerland.""}, {'ForeName': 'Pedro-Manuel', 'Initials': 'PM', 'LastName': 'Marques-Vidal', 'Affiliation': 'Faculty of Biology and Medicine, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Fetz', 'Affiliation': ""Clinica Sant'Anna, Sorengo, Switzerland.""}, {'ForeName': 'Salah D', 'Initials': 'SD', 'LastName': 'Qanadli', 'Affiliation': 'Cardiothoracic and Vascular Division, Department of Diagnostic and Interventional Radiology, Lausanne University Hospital, Lausanne, Switzerland.'}]",Frontiers in cardiovascular medicine,['10.3389/fcvm.2020.00068']
1484,32411853,The TOBg Tobacco Treatment Guidelines for Adolescents: A real-world pilot study.,"INTRODUCTION


We conducted a pilot study to: 1) obtain feedback from prevention practitioners in terms of their satisfaction, knowledge, and self-efficacy following exposure to the Tobacco Treatment Guidelines for Adolescents (TOBg Guidelines); and 2) examine the effectiveness of a school-based intervention based on the TOBg Guidelines on quit rates among a sample of adolescent tobacco users.
METHODS


Two parallel studies were conducted. In Study 1, prevention practitioners were exposed to a 1-day training in the TOBg Guidelines with assessment occurring before, immediately after, and at 6 months following the training. In Study 2, participating adolescent smokers were exposed to a 3-session group-based smoking cessation intervention that drew on the TOBg Guidelines and was delivered by practitioners trained in Study 1. The primary outcome measure was self-reported smoking status assessed at 1 month and at 6 months following baseline.
RESULTS


A total of 18 prevention practitioners and 65 adolescent tobacco users participated in the pilot study. The majority of practitioners reported high rates of satisfaction with the TOBg Guidelines and indicated that the guidelines positively influenced the manner in which they addressed tobacco use with adolescents. Prevention practitioners' self-efficacy for intervening with adolescent smokers was also significantly increased following exposure to the TOBg Guidelines and training. Among adolescents exposed to the school-based intervention, 62.5% and 23.1% had reduced smoking by 50% or more at 1 month and at 6 months follow-up, respectively. No significant change in smoking abstinence was documented.
CONCLUSIONS


The TOBg Guidelines for adolescent smokers were well received by prevention practitioners and were feasible to implement in a real-world school setting.",2018,Prevention practitioners' self-efficacy for intervening with adolescent smokers was also significantly increased following exposure to the TOBg Guidelines and training.,"['Adolescents', '18 prevention practitioners and 65 adolescent tobacco users participated in the pilot study', 'adolescent smokers', 'participating adolescent smokers', 'adolescent tobacco users']","['3-session group-based smoking cessation intervention that drew on the TOBg Guidelines', 'TOBg Guidelines']","['self-reported smoking status', 'smoking abstinence', 'quit rates', 'reduced smoking']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C3853727', 'cui_str': 'Tobacco user'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]",,0.0228693,Prevention practitioners' self-efficacy for intervening with adolescent smokers was also significantly increased following exposure to the TOBg Guidelines and training.,"[{'ForeName': 'Anastasios', 'Initials': 'A', 'LastName': 'Fotiou', 'Affiliation': 'University Mental Health Research Institute (UMHRI), Athens, Greece.'}, {'ForeName': 'Myrto', 'Initials': 'M', 'LastName': 'Stavrou', 'Affiliation': 'University Mental Health Research Institute (UMHRI), Athens, Greece.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Papadakis', 'Affiliation': 'Division of Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, Canada.'}, {'ForeName': 'Panagiotis K', 'Initials': 'PK', 'LastName': 'Behrakis', 'Affiliation': 'George D. Behrakis Research Lab, Hellenic Cancer Society, Athens, Greece.'}, {'ForeName': 'Constantine I', 'Initials': 'CI', 'LastName': 'Vardavas', 'Affiliation': 'Institute of Public Health, American College of Greece, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kyriakidou', 'Affiliation': 'PYXIDA Prevention Centre, Thessaloniki, Greece.'}, {'ForeName': 'Sotiria', 'Initials': 'S', 'LastName': 'Makaroni', 'Affiliation': 'PRONOI Prevention Centre, Athens, Greece.'}, {'ForeName': 'Theodosia', 'Initials': 'T', 'LastName': 'Peleki', 'Affiliation': 'Institute of Public Health, American College of Greece, Athens, Greece.'}, {'ForeName': 'Vergina', 'Initials': 'V', 'LastName': 'Vyzikidou', 'Affiliation': 'Institute of Public Health, American College of Greece, Athens, Greece.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kokkevi', 'Affiliation': 'University Mental Health Research Institute (UMHRI), Athens, Greece.'}]",Tobacco prevention & cessation,['10.18332/tpc/93008']
1485,31177999,Effects of Mediterranean diet supplemented with lean pork on blood pressure and markers of cardiovascular risk: findings from the MedPork trial.,"The Mediterranean diet offers a range of health benefits. However, previous studies indicate that the restricted consumption of red meat in the diet may affect long-term sustainability in non-Mediterranean countries. A 24-week randomised controlled parallel cross-over design compared a Mediterranean diet supplemented with 2-3 serves per week of fresh, lean pork (MedPork) with a low-fat control diet (LF). Thirty-three participants at risk of CVD followed each intervention for 8 weeks, with an 8-week washout period separating interventions. The primary outcome was home-measured systolic blood pressure. Secondary outcomes included diastolic blood pressure, fasting lipids, glucose, insulin, C-reactive protein (CRP), body composition and dietary adherence. During the MedPork intervention, participants achieved high adherence to dietary guidelines. Compared with the MedPork intervention, the LF intervention led to greater reductions in weight (Δ = -0·65; 95 % CI -0·04, -1·25 kg, P = 0·04), BMI (Δ = -0·25; 95 % CI -0·03, -0·47 kg/m2, P = 0·01) and waist circumference (Δ = -1·40; 95 % CI -0·45, -2·34 cm, P < 0·01). No significant differences were observed for blood pressure, lipids, glucose, insulin or CRP. These findings indicate that Australians are capable of adhering to a Mediterranean diet with 2-3 weekly serves of fresh, lean pork. Larger intervention studies are now required to demonstrate clinical efficacy of the diet in populations with elevated blood pressure.",2019,"Compared with the MedPork intervention, the LF intervention led to greater reductions in weight (Δ = 0·65; 95 % CI: 0·04, 1·25 kg, P = 0·04),",[],"['Mediterranean diet supplemented with 2-3 serves per week of fresh, lean pork (MedPork) with a low-fat control diet (LF', 'Mediterranean diet supplemented with lean pork', 'LF intervention']","['waist circumference', 'BMI', 'blood pressure and markers of cardiovascular risk', 'blood pressure, lipids, glucose, insulin or CRP', 'home-measured systolic blood pressure', 'diastolic blood pressure, fasting lipids, glucose, insulin, C-reactive protein (CRP), body composition and dietary adherence', 'weight']",[],"[{'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0452867', 'cui_str': 'Pork'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0452286', 'cui_str': 'Fat controlled diet (finding)'}]","[{'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",,0.0709223,"Compared with the MedPork intervention, the LF intervention led to greater reductions in weight (Δ = 0·65; 95 % CI: 0·04, 1·25 kg, P = 0·04),","[{'ForeName': 'Alexandra T', 'Initials': 'AT', 'LastName': 'Wade', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, School of Health Sciences, University of South Australia, GPO Box 2471, Adelaide, SA 5001, Australia.'}, {'ForeName': 'Courtney R', 'Initials': 'CR', 'LastName': 'Davis', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, School of Health Sciences, University of South Australia, GPO Box 2471, Adelaide, SA 5001, Australia.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Dyer', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, School of Health Sciences, University of South Australia, GPO Box 2471, Adelaide, SA 5001, Australia.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Hodgson', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Perth, WA 6000, Australia.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Woodman', 'Affiliation': 'Flinders Centre for Epidemiology and Biostatistics, Flinders University, GPO Box 2100 Adelaide, SA 5001, Australia.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Murphy', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, School of Health Sciences, University of South Australia, GPO Box 2471, Adelaide, SA 5001, Australia.'}]",The British journal of nutrition,['10.1017/S0007114519001168']
1486,32411753,"Investigation of nicotinamide as more than an anti-phosphorus drug in chronic hemodialysis patients: a single-center, double-blind, randomized, placebo-controlled trial.","Background


Hyperphosphatemia is a common complication of late-stage chronic kidney disease (CKD). Nicotinamide (NAM) has been reported as an adjunctive therapy for hyperphosphatasemia, but the effect of NAM on fibroblast growth factor 23 (FGF23) and Klotho has rarely been reported.
Methods


We randomly assigned 98 patients who underwent regular hemodialysis to received NAM (0.5-1.5 g per day, or 1-3 tablets per day) or placebo (1-3 tablets per day) as an add-on therapy of calcium-based phosphorus binders in a 1:1 ratio. All enrollments were followed-up for 52 weeks. We investigated the serum phosphorus as the primary outcome and serum FGF23 and Klotho as the secondary outcomes. Abdominal aortic calcification (AAC), which had a good correlation with coronary calcification was also compared between the two groups.
Results


In total, 37 patients in the placebo group and 35 patients in the NAM group completed the 52-week follow-up. Compared with the placebo group, the NAM group showed a significant decrease of serum phosphorus at the 8 th , 12 th , 20 th , 44 th , and 52 nd  week. There was a declining trend of FGF23 and Klotho in both the placebo and NAM groups. Linear mixed models (LMMs) for overall comparisons by repeated measures of analysis of variance (ANOVA) revealed a significant decrease of FGF23 and slower declining rate of Klotho in the NAM group. No significant difference of AAC was detected between the two groups (P=0.805).
Conclusions


NAM can not only further decrease the phosphorus level but also reduce the FGF23 level and slow down the descending rate of Klotho in chronic hemodialysis patients.",2020,"Compared with the placebo group, the NAM group showed a significant decrease of serum phosphorus at the 8 th , 12 th , 20 th , 44 th , and 52 nd  week.","['chronic hemodialysis patients', '98 patients who underwent', 'late-stage chronic kidney disease (CKD', '37 patients in the']","['calcium-based phosphorus binders', 'Nicotinamide (NAM', 'regular hemodialysis to received NAM', 'NAM', 'nicotinamide', 'placebo']","['serum phosphorus', 'phosphorus level', 'Abdominal aortic calcification (AAC', 'FGF23 and Klotho', 'FGF23', 'AAC']","[{'cui': 'C1740835', 'cui_str': 'Chronic haemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C1096249', 'cui_str': 'Aortic calcification'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C1144173', 'cui_str': 'KL protein, human'}]",98.0,0.358814,"Compared with the placebo group, the NAM group showed a significant decrease of serum phosphorus at the 8 th , 12 th , 20 th , 44 th , and 52 nd  week.","[{'ForeName': 'Xiang-Yang', 'Initials': 'XY', 'LastName': 'Liu', 'Affiliation': 'NHC Key Lab of Hormones and Development (Tianjin Medical University), Tianjin Key Lab of Metabolic Diseases, Metabolic Diseases Hospital & Institute of Endocrinology, Tianjin Medical University, Tianjin 300070, China.'}, {'ForeName': 'Jing-Rui', 'Initials': 'JR', 'LastName': 'Yao', 'Affiliation': 'Department of Nephrology, Tianjin Haihe Hospital, Tianjin 300300, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'NHC Key Lab of Hormones and Development (Tianjin Medical University), Tianjin Key Lab of Metabolic Diseases, Metabolic Diseases Hospital & Institute of Endocrinology, Tianjin Medical University, Tianjin 300070, China.'}, {'ForeName': 'Lin-Xin', 'Initials': 'LX', 'LastName': 'Xu', 'Affiliation': 'NHC Key Lab of Hormones and Development (Tianjin Medical University), Tianjin Key Lab of Metabolic Diseases, Metabolic Diseases Hospital & Institute of Endocrinology, Tianjin Medical University, Tianjin 300070, China.'}, {'ForeName': 'Yue-Feng', 'Initials': 'YF', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, Tianjin Haihe Hospital, Tianjin 300300, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'NHC Key Lab of Hormones and Development (Tianjin Medical University), Tianjin Key Lab of Metabolic Diseases, Metabolic Diseases Hospital & Institute of Endocrinology, Tianjin Medical University, Tianjin 300070, China.'}, {'ForeName': 'Zhi-Heng', 'Initials': 'ZH', 'LastName': 'Xing', 'Affiliation': 'Department of Radiology, Tianjin Haihe Hospital, Tianjin 300300, China.'}, {'ForeName': 'Li-Ping', 'Initials': 'LP', 'LastName': 'Fan', 'Affiliation': 'Department of Nephrology, Tianjin Haihe Hospital, Tianjin 300300, China.'}, {'ForeName': 'Zhong-Hua', 'Initials': 'ZH', 'LastName': 'Qin', 'Affiliation': 'Department of Clinical Laboratory, Tianjin Haihe Hospital, Tianjin 300300, China.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': 'NHC Key Lab of Hormones and Development (Tianjin Medical University), Tianjin Key Lab of Metabolic Diseases, Metabolic Diseases Hospital & Institute of Endocrinology, Tianjin Medical University, Tianjin 300070, China.'}]",Annals of translational medicine,['10.21037/atm.2020.03.228']
1487,32411845,Passive exposure to e-cigarette emissions: Immediate respiratory effects.,"INTRODUCTION


The present work examined the effect of passive exposure to electronic-cigarette (e-cigarette) emissions on respiratory mechanics and exhaled inflammatory biomarkers.
METHODS


A cross-over experimental study was conducted with 40 healthy nonsmokers, 18-35 years old with normal physical examination and spirometry, with body mass index <30 kg/m 2 , who were exposed to e-cigarette emissions produced by a smoker, according to a standardized protocol based on two resistance settings, 0.5 ohm and 1.5 ohm, for e-cigarette use. All participants underwent a 30-minute control (no emissions) and two experimental sessions (0.5 and 1.5 ohm exposure) in a 35 m 3  room. The following Impulse Oscillometry (IOS) parameters were measured at pre and post sessions: impedance, resistance, reactance, resonant frequency ( fres ), frequency dependence of resistance ( fdr =R5-R20), reactance area (AX), and fractional exhaled nitric oxide (FeNO). Differences between pre and post measurements were compared using t-tests and Wilcoxon signed rank tests, while analysis of variance (ANOVA) was used for comparisons between experimental sessions (registered under ClinicalTrials.gov ID: NCT03102684).
RESULTS


IOS and FeNO parameters showed no significant changes during the control session. For IOS during the 1.5 ohm exposure session,  fres  increased significantly from 11.38 Hz at baseline to 12.16 Hz post exposure (p=0.047). FeNO decreased significantly from 24.16 ppb at baseline to 22.35 ppb post exposure in the 0.5 ohm session (p=0.006).
CONCLUSIONS


A 30-minute passive exposure to e-cigarette emissions revealed immediate alterations in respiratory mechanics and exhaled biomarkers, expressed as increased  fres  and reduced FeNO.",2018,"FeNO decreased significantly from 24.16 ppb at baseline to 22.35 ppb post exposure in the 0.5 ohm session (p=0.006).
","['40 healthy nonsmokers, 18-35 years old with normal physical examination and spirometry, with body mass index <30 kg/m 2 , who were exposed to e-cigarette emissions produced by a smoker, according to a standardized protocol based on two resistance settings, 0.5 ohm and 1.5 ohm, for e-cigarette use']","['30-minute control (no emissions) and two experimental sessions', 'passive exposure to electronic-cigarette (e-cigarette) emissions']","['impedance, resistance, reactance, resonant frequency ( fres ), frequency dependence of resistance ( fdr =R5-R20), reactance area (AX), and fractional exhaled nitric oxide (FeNO', 'respiratory mechanics and exhaled biomarkers, expressed as increased  fres  and reduced FeNO', 'FeNO', 'Impulse Oscillometry (IOS) parameters']","[{'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0560037', 'cui_str': 'ohm'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C4083280', 'cui_str': 'Vape'}]","[{'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0037370', 'cui_str': 'Passive smoking'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}]","[{'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0577554', 'cui_str': 'Resonant'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0029375', 'cui_str': 'Oscillometry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",40.0,0.0151613,"FeNO decreased significantly from 24.16 ppb at baseline to 22.35 ppb post exposure in the 0.5 ohm session (p=0.006).
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tzortzi', 'Affiliation': 'George D. Behrakis Research Lab, Hellenic Cancer Society, Athens, Greece.'}, {'ForeName': 'Stephanie I', 'Initials': 'SI', 'LastName': 'Teloniatis', 'Affiliation': 'George D. Behrakis Research Lab, Hellenic Cancer Society, Athens, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Matiampa', 'Affiliation': 'George D. Behrakis Research Lab, Hellenic Cancer Society, Athens, Greece.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Bakelas', 'Affiliation': 'George D. Behrakis Research Lab, Hellenic Cancer Society, Athens, Greece.'}, {'ForeName': 'Vergina K', 'Initials': 'VK', 'LastName': 'Vyzikidou', 'Affiliation': 'George D. Behrakis Research Lab, Hellenic Cancer Society, Athens, Greece.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Vardavas', 'Affiliation': 'George D. Behrakis Research Lab, Hellenic Cancer Society, Athens, Greece.'}, {'ForeName': 'Panagiotis K', 'Initials': 'PK', 'LastName': 'Behrakis', 'Affiliation': 'George D. Behrakis Research Lab, Hellenic Cancer Society, Athens, Greece.'}, {'ForeName': 'Esteve', 'Initials': 'E', 'LastName': 'Fernandez', 'Affiliation': ""Tobacco Control Unit, Institut Català d'Oncologia (ICO) and Institut d'Investigació Bioomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}]",Tobacco prevention & cessation,['10.18332/tpc/89977']
1488,31524123,The effects of supplementing maternal and infant diets with lipid-based nutrient supplements on physical activity and sedentary behaviour at preschool age in Ghana.,"Evidence on whether nutritional supplementation affects physical activity (PA) during early childhood is limited. We examined the long-term effects of lipid-based nutrient supplements (LNS) on total PA, moderate-to-vigorous PA (MVPA) and sedentary behaviour (SB) of children at 4-6 years using an accelerometer for 1 week. Their mothers were enrolled in the International Lipid-based Nutrient Supplement-DYAD randomised controlled trial in Ghana, assigned to daily LNS or multiple micronutrients (MMN) during pregnancy through 6 months postpartum or Fe and folic acid (IFA) during pregnancy and placebo for 6 months postpartum. From 6 to 18 months, children in the LNS group received LNS; the other two groups received no supplements. Analysis was done with intention to treat comparing two groups: LNS v. non-LNS (MMN+ IFA). Of the sub-sample of 375 children fitted with accelerometers, 353 provided sufficient data. Median vector magnitude (VM) count was 1374 (interquartile range (IQR) 309), and percentages of time in MVPA and SB were 4·8 (IQR 2) and 31 (IQR 8) %, respectively. The LNS group (n 129) had lower VM (difference in mean -73 (95 % CI -20, -126), P = 0·007) and spent more time in SB (LNS v. non-LNS: 32·3 v. 30·5 %, P = 0·020) than the non-LNS group (n 224) but did not differ in MVPA (4·4 v. 4·7 %, P = 0·198). Contrary to expectations, provision of LNS in early life slightly reduced the total PA and increased the time in SB but did not affect time in MVPA. Given reduced social-emotional difficulties in the LNS group previously reported, including hyperactivity, one possible explanation is less restless movement in the LNS group.",2019,The LNS group (n 129) had lower VM (difference in mean -73,"['children at 4-6\xa0years using an accelerometer for 1\xa0week', '375 children fitted with accelerometers, 353 provided sufficient data', 'at preschool age in Ghana']","['LNS', 'LNS v. non-LNS (MMN+ IFA', 'lipid-based nutrient supplements (LNS', 'nutritional supplementation', 'supplementing maternal and infant diets with lipid-based nutrient supplements', 'LNS or multiple micronutrients (MMN) during pregnancy through 6 months postpartum or Fe and folic acid (IFA) during pregnancy and placebo']","['total PA, moderate-to-vigorous PA (MVPA) and sedentary behaviour (SB', 'physical activity and sedentary behaviour', 'percentages of time in MVPA and SB', 'social-emotional difficulties', 'physical activity (PA', 'spent more time in SB', 'Median vector magnitude (VM) count', 'time in SB', 'lower VM', 'total PA']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4517745', 'cui_str': '375 (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0311143', 'cui_str': 'Infant diet'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0442335', 'cui_str': 'Vectors (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",375.0,0.148214,The LNS group (n 129) had lower VM (difference in mean -73,"[{'ForeName': 'Maku E', 'Initials': 'ME', 'LastName': 'Ocansey', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pulakka', 'Affiliation': 'Department of Public Health, University of Turku and Turku University Hospital, 20014 Turku, Finland.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Adu-Afarwuah', 'Affiliation': 'Department of Nutrition and Food Science, University of Ghana, Legon 20520, Ghana.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Young', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'Sika M', 'Initials': 'SM', 'LastName': 'Kumordzie', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Okronipa', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'Brietta M', 'Initials': 'BM', 'LastName': 'Oaks', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Prado', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA 95616, USA.'}]",The British journal of nutrition,['10.1017/S0007114519001636']
1489,32411854,Short-term impact of the EuroPean Accredited Curriculum on Tobacco Treatment Training (EPACTT) program.,"INTRODUCTION


The aim of this pilot study was to assess the short-term effectiveness of the EuroPean Accredited Curriculum on Tobacco Treatment Training intervention in improving health care providers' knowledge, attitudes and self-efficacy related to tobacco dependence treatment.
METHODS


A pre-post pilot study was conducted. The two-day training intervention took place in Brussels in April 2016. Health care professionals from six European countries (Russia, Ukraine, Georgia, Armenia, Romania and Greece) were purposively invited to participate in the study. Evaluation was performed before the intervention, immediately after, and at approximately two months following the intervention. Changes in outcomes of interest were examined before and after exposure to the intervention program.
RESULTS


In all, 47 health care professionals participated in the training of which 40 completed the evaluation surveys. Significant increases in providers' self-efficacy and perceived behavioral control related to tobacco treatment delivery were documented immediately following the training and at the 2 months follow-up. Significant improvement in provider knowledge and attitudes were observed in some items assessed.
CONCLUSIONS


The results demonstrate that training is able to improve provider self-efficacy related to tobacco treatment delivery in this cross-national European sample of health care professionals. Additional research is required to examine the generalizability of our findings.",2018,Significant increases in providers' self-efficacy and perceived behavioral control related to tobacco treatment delivery were documented immediately following the training and at the 2 months follow-up.,"['47 health care professionals participated in the training of which 40 completed the evaluation surveys', 'Health care professionals from six European countries (Russia, Ukraine, Georgia, Armenia, Romania and Greece) were purposively invited to participate in the study']",['EuroPean Accredited Curriculum on Tobacco Treatment Training intervention'],"['provider self-efficacy', ""providers' self-efficacy and perceived behavioral control related to tobacco treatment delivery"", 'provider knowledge and attitudes']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0041580', 'cui_str': 'Ukraine'}, {'cui': 'C0017452', 'cui_str': 'Georgia state'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0035826', 'cui_str': 'Romania'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0114828,Significant increases in providers' self-efficacy and perceived behavioral control related to tobacco treatment delivery were documented immediately following the training and at the 2 months follow-up.,"[{'ForeName': 'Theodosia', 'Initials': 'T', 'LastName': 'Peleki', 'Affiliation': 'National and Kapodistrian University of Athens, School of Health Sciences, Department of Medicine, Athens, Greece.'}, {'ForeName': 'Charis', 'Initials': 'C', 'LastName': 'Girvalaki', 'Affiliation': 'Clinic of Social and Family Medicine, Medical School, University of Crete, Heraklion, Greece.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Lozano', 'Affiliation': 'European Network for Smoking and Tobacco Prevention (ENSP), Brussels, Belgium.'}, {'ForeName': 'Cornel', 'Initials': 'C', 'LastName': 'Radu-Loghin', 'Affiliation': 'European Network for Smoking and Tobacco Prevention (ENSP), Brussels, Belgium.'}, {'ForeName': 'Dominick', 'Initials': 'D', 'LastName': 'Nguyen', 'Affiliation': 'European Network for Smoking and Tobacco Prevention (ENSP), Brussels, Belgium.'}, {'ForeName': 'Arusyak', 'Initials': 'A', 'LastName': 'Harutyunyan', 'Affiliation': 'School of Public Health, American University of Armenia, Armenia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Bakhturidze', 'Affiliation': 'FCTC Implementation and Monitoring Center, Georgia.'}, {'ForeName': 'Antigona', 'Initials': 'A', 'LastName': 'Trofor', 'Affiliation': ""University of Medicine and Pharmacy 'Grigore T.Popa', Iasi, Romania.""}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Demin', 'Affiliation': 'Federal State Funded Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University under the Ministry of Health of the Russian Federation, Russia.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Stoyka', 'Affiliation': 'Kyiv City Health Center, Ukraine.'}, {'ForeName': 'Chrysoula', 'Initials': 'C', 'LastName': 'Tsiou', 'Affiliation': 'Technological Educational Institute of Athens, Greece.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Papadakis', 'Affiliation': 'Division of Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Constantine I', 'Initials': 'CI', 'LastName': 'Vardavas', 'Affiliation': 'European Network for Smoking and Tobacco Prevention (ENSP), Brussels, Belgium.'}, {'ForeName': 'Panagiotis K', 'Initials': 'PK', 'LastName': 'Behrakis', 'Affiliation': 'Institute of Public Health, American College of Greece, Athens, Greece.'}]",Tobacco prevention & cessation,['10.18332/tpc/92484']
1490,32411903,The effectiveness of family counselling on reducing exposure to secondhand smoke at home among pregnant women in Iran.,"INTRODUCTION


Pregnant women are often exposed to secondhand smoke that affects them and their child. Our aim was to determine the effectiveness of family counselling using the BASNEF model on reducing exposure to secondhand smoke at home among pregnant women.
METHODS


A quasi-experimental study was conducted on 103 pregnant women exposed to secondhand smoke. They were selected using a multi-stage cluster sampling method and allocated into intervention (50 people) and control (53 people) groups. Four family counseling sessions using the BASNEF model were held for the intervention group while the control group received routine care. The outcomes were measured before and at one month after the last session of counselling.
RESULTS


In the timeframe before the intervention, the number of days in which there was reported exposure to secondhand smoke was 5.08 ± 1.1 in the intervention group, significantly decreasing to 3.5 ± 1.6 after the intervention (p<0.001). No significant change was observed in the control group (p=0.1). Also, the mean scores of all constructs of the BASNEF model increased significantly after the intervention compared to those of the control group (p<0.05).
CONCLUSIONS


Family counseling had a positive effect on decreasing the exposure to secondhand smoke at home among a sample of pregnant women. The BASNEF model is useful for implementing educational care programs in these settings.",2019,Four family counseling sessions using the BASNEF model were held for the intervention group while the control group received routine care.,"['Pregnant women', 'pregnant women in Iran', '103 pregnant women exposed to secondhand smoke', 'pregnant women']","['family counselling', 'BASNEF model', 'routine care']",['mean scores of all constructs of the BASNEF model'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0037370', 'cui_str': 'Passive smoking'}]","[{'cui': 'C0152055', 'cui_str': 'Family counseling'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",103.0,0.0205619,Four family counseling sessions using the BASNEF model were held for the intervention group while the control group received routine care.,"[{'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Soltani', 'Affiliation': 'Mother and Child Care Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Barzegar', 'Affiliation': 'Student Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Sangestani', 'Affiliation': 'Mother and Child Care Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Ghodratolah', 'Initials': 'G', 'LastName': 'Roshanaii', 'Affiliation': 'Modeling of Non-CommunicableDiseases Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Maleki', 'Affiliation': 'Social Determinants of Health Research Center, Zanjan University of Medical Sciences, Zanjan, Iran.'}]",Tobacco prevention & cessation,['10.18332/tpc/113105']
1491,31597484,"Effect of acute watermelon juice supplementation on post-submaximal exercise heart rate recovery, blood lactate, blood pressure, blood glucose and muscle soreness in healthy non-athletic men and women.","The objective of this study was to determine the effects of a single pre-exercise dose of watermelon juice on submaximal post-exercise heart rate (HR) recovery, blood lactate (BL), blood pressure (BP), blood glucose (BG), and muscle soreness in healthy adults. In a randomised crossover design, 27 healthy non-athletic participants (13 males/14 females) consumed 355 mL of watermelon juice, Gatorade, sugar water, or water. HR and BL were significantly higher post-exercise, and both watermelon juice and sugar water increased postprandial BG. However, there were no significant differences among the supplements in HR recovery, BL, or post-exercise muscle soreness. Watermelon juice prevented increased post-exercise systolic and diastolic BP in females, but not in males. More research is warranted to examine the effect of sex on the efficacy of watermelon consumption for controlling BP.",2020,"However, there were no significant differences among the supplements in HR recovery, BL, or post-exercise muscle soreness.","['27 healthy non-athletic participants (13 males/14 females', 'healthy adults', 'healthy non-athletic men and women']","['acute watermelon juice supplementation', 'single pre-exercise dose of watermelon juice', 'consumed 355\u2009mL of watermelon juice, Gatorade, sugar water, or water']","['submaximal post-exercise heart rate (HR) recovery, blood lactate (BL), blood pressure (BP), blood glucose (BG), and muscle soreness', 'HR recovery, BL, or post-exercise muscle soreness', 'post-exercise systolic and diastolic BP', 'post-submaximal exercise heart rate recovery, blood lactate, blood pressure, blood glucose and muscle soreness', 'HR and BL', 'watermelon juice and sugar water increased postprandial BG']","[{'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0973455', 'cui_str': 'Watermelon'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0206948', 'cui_str': 'gatorade'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0973455', 'cui_str': 'Watermelon'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}]",27.0,0.089946,"However, there were no significant differences among the supplements in HR recovery, BL, or post-exercise muscle soreness.","[{'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Blohm', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Beidler', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Rosen', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Kressler', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Mee Young', 'Initials': 'MY', 'LastName': 'Hong', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, USA.'}]",International journal of food sciences and nutrition,['10.1080/09637486.2019.1675604']
1492,32412417,A Mobile App Lifestyle Intervention to Improve Healthy Nutrition in Women Before and During Early Pregnancy: Single-Center Randomized Controlled Trial.,"BACKGROUND


Unhealthy nutrition contributes to the worldwide rising prevalence of noncommunicable diseases. As most adverse reproductive outcomes originate during the periconception period, effective interventions targeting this period are needed. Therefore, we developed the lifestyle intervention Smarter Pregnancy to empower women to adapt a healthy diet prior to conception and during early pregnancy and performed a randomized controlled trial.
OBJECTIVE


The objectives of this trial were to investigate compliance and effectiveness in women using the Smarter Pregnancy program.
METHODS


Women aged between 18 and 45 years who were contemplating pregnancy or <13 weeks pregnant and their male partners living in the urban area of Rotterdam, the Netherlands, were eligible for participation. After baseline screening, the intervention group received personal online coaching based on identified inadequate intakes of vegetables, fruits, and folic acid supplements. The sum of these risk factors was used as a dietary risk score (DRS), ranging from 0 (healthy) to 9 (unhealthy). The control group did not receive coaching. We applied an intention-to-treat principle and used a multivariable linear regression model to evaluate the change in DRS after 24 weeks. Compliance was defined as the percentage of women who completed the screening questionnaire at 24 weeks.
RESULTS


Of women recruited, 81.2% (177/218) completed the program (intervention: 91/218, 83.5%; control: 86/218, 78.9%; P=.95). After 24 weeks, the reduction in DRS of women in the intervention group was significantly larger than in the control group (β=.75, 95% CI 0.18-1.34). This reduction was mainly due to increased vegetable intake (β=.55, 95% CI 0.25-0.86).
CONCLUSIONS


The high compliance and the larger improvements in nutritional behaviors, especially vegetable intake, in women in the intervention group emphasizes the effectiveness of empowering women by using the lifestyle change intervention Smarter Pregnancy.
TRIAL REGISTRATION


Netherlands Trial Register: NL3927; https://www.trialregister.nl/trial/3927.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1186/s12884-017-1228-5.",2020,"This reduction was mainly due to increased vegetable intake (β=.55, 95% CI 0.25-0.86).
","['Women aged between 18 and 45 years who were contemplating pregnancy or <13 weeks pregnant and their male partners living in the urban area of Rotterdam, the Netherlands, were eligible for participation', 'Healthy Nutrition in Women Before and During Early Pregnancy', 'women using the Smarter Pregnancy program']","['control group did not receive coaching', 'personal online coaching based on identified inadequate intakes of vegetables, fruits, and folic acid supplements', 'Mobile App Lifestyle Intervention']","['reduction in DRS', 'vegetable intake', 'compliance and effectiveness', 'dietary risk score (DRS']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0460089', 'cui_str': 'Finding of length of gestation'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C5200690', 'cui_str': 'Healthy Nutrition'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.112521,"This reduction was mainly due to increased vegetable intake (β=.55, 95% CI 0.25-0.86).
","[{'ForeName': 'Matthijs R', 'Initials': 'MR', 'LastName': 'van Dijk', 'Affiliation': 'Department of Obstetrics and Gynaecology, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Maria P H', 'Initials': 'MPH', 'LastName': 'Koster', 'Affiliation': 'Department of Obstetrics and Gynaecology, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Elsje C', 'Initials': 'EC', 'LastName': 'Oostingh', 'Affiliation': 'Department of Obstetrics and Gynaecology, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Sten P', 'Initials': 'SP', 'LastName': 'Willemsen', 'Affiliation': 'Department of Biostatistics, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Eric A P', 'Initials': 'EAP', 'LastName': 'Steegers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Régine P M', 'Initials': 'RPM', 'LastName': 'Steegers-Theunissen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, Netherlands.'}]",Journal of medical Internet research,['10.2196/15773']
1493,26054049,"Effect of reducing portion size at a compulsory meal on later energy intake, gut hormones, and appetite in overweight adults.","OBJECTIVE


Larger portion sizes (PS) are associated with greater energy intake (EI), but little evidence exists on the appetitive effects of PS reduction. This study investigated the impact of reducing breakfast PS on subsequent EI, postprandial gastrointestinal hormone responses, and appetite ratings.
METHODS


In a randomized crossover design (n = 33 adults; mean BMI 29 kg/m(2) ), a compulsory breakfast was based on 25% of gender-specific estimated daily energy requirements; PS was reduced by 20% and 40%. EI was measured at an ad libitum lunch (240 min) and snack (360 min) and by weighed diet diaries until bed. Blood was sampled until lunch in 20 participants. Appetite ratings were measured using visual analogue scales.
RESULTS


EI at lunch (control: 2,930 ± 203; 20% reduction: 2,853 ± 198; 40% reduction: 2,911 ± 179 kJ) and over the whole day except breakfast (control: 7,374 ± 361; 20% reduction: 7,566 ± 468; 40% reduction: 7,413 ± 417 kJ) did not differ. Postprandial PYY, GLP-1, GIP, insulin, and fullness profiles were lower and hunger, desire to eat, and prospective consumption higher following 40% reduction compared to control. Appetite ratings profiles, but not hormone concentrations, were associated with subsequent EI.
CONCLUSIONS


Smaller portions at breakfast led to reductions in gastrointestinal hormone secretion but did not affect subsequent energy intake, suggesting small reductions in portion size may be a useful strategy to constrain EI.",2015,"Postprandial PYY, GLP-1, GIP, insulin, and fullness profiles were lower and hunger, desire to eat, and prospective consumption higher following 40% reduction compared to control.","['overweight adults', 'n\u2009=\u200933 adults; mean BMI 29 kg/m(2) ']",[],"['subsequent EI, postprandial gastrointestinal hormone responses, and appetite ratings', 'later energy intake, gut hormones, and appetite', 'Appetite ratings', 'Postprandial PYY, GLP-1, GIP, insulin, and fullness profiles were lower and hunger, desire to eat, and prospective consumption higher', 'gastrointestinal hormone secretion', 'Appetite ratings profiles']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",[],"[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0017182', 'cui_str': 'Gastrointestinal Hormones'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}]",,0.0624279,"Postprandial PYY, GLP-1, GIP, insulin, and fullness profiles were lower and hunger, desire to eat, and prospective consumption higher following 40% reduction compared to control.","[{'ForeName': 'Hannah B', 'Initials': 'HB', 'LastName': 'Lewis', 'Affiliation': 'Diet and Obesity Research, Medical Research Council Human Nutrition Research, Cambridge, UK.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Ahern', 'Affiliation': 'Diet and Obesity Research, Medical Research Council Human Nutrition Research, Cambridge, UK.'}, {'ForeName': 'Ivonne', 'Initials': 'I', 'LastName': 'Solis-Trapala', 'Affiliation': 'Diet and Obesity Research, Medical Research Council Human Nutrition Research, Cambridge, UK.'}, {'ForeName': 'Celia G', 'Initials': 'CG', 'LastName': 'Walker', 'Affiliation': 'Diet and Obesity Research, Medical Research Council Human Nutrition Research, Cambridge, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Reimann', 'Affiliation': 'Department of Clinical Biochemistry, Institute of Metabolic Science, University of Cambridge, UK.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Gribble', 'Affiliation': 'Department of Clinical Biochemistry, Institute of Metabolic Science, University of Cambridge, UK.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Diet and Obesity Research, Medical Research Council Human Nutrition Research, Cambridge, UK.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.21105']
1494,32412419,A Lower Leg Physical Activity Intervention for Individuals With Chronic Venous Leg Ulcers: Randomized Controlled Trial.,"BACKGROUND


Individuals with venous leg ulcers (VLUs) suffer disproportionately with multiple chronic conditions, are often physically deconditioned, and demonstrate high levels of physical inactivity.
OBJECTIVE


The primary objective of this randomized controlled trial was to establish the feasibility of a mobile health (mHealth) physical activity exercise app for individuals with VLUs to improve lower leg function.
METHODS


In a 6-week study, adults with VLUs were recruited from 2 wound centers in South Carolina, United States, and enrolled if they were aged 18 years or older with impaired functional mobility and an ankle-brachial index between 0.8 and 1.3. Participants were randomized 1:1 to receive evidence-based, phased, nonexertive physical conditioning activities for lower leg function (FOOTFIT) or FOOTFIT+ with an added patient-provider communication feature. The mHealth Conditioning Activities for Lower Leg Function app also provided automated educational and motivational messages and user reports. Foot movement on the VLU-affected leg was tracked by a Bluetooth-enabled triaxial accelerometer. The study was guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework to assess the feasibility of reach, adherence, acceptability, implementation, and maintenance.
RESULTS


A total of 24 patients were recruited, enrolled, and randomized in the study. Most patients reported difficulty following the protocol for exercising and using the accelerometer and mobile phone and did not use the provider contact feature. However, all patients were adherent to the 6-week exercise program more than 85% of the time for duration, whereas 33% (8/24) of patients adhered more than 85% for the frequency of performing the exercises. Across the three exercise levels, adherence did not differ between the two groups. Confidence limits around the difference in proportions ranged from -0.4 to 0.7. Providers in FOOTFIT+ were inconsistent in checking participant progress reports because of lack of time from competing work commitments. The technology became outdated quickly, making maintenance problematic. Participants said they would continue to exercise their foot and legs and liked being able to follow along with the demonstrations of each level of exercise provided through the app.
CONCLUSIONS


The findings of this study suggest that despite initial interest in using the app, several components of the program as originally designed had limited acceptability and feasibility. Future refinements should include the use of more modern technology including smaller wearable accelerometers, mobile phones or tablets with larger screens, an app designed with larger graphics, automated reporting for providers, and more engaging user features.
TRIAL REGISTRATION


ClinicalTrials.gov NTC02632695; https://clinicaltrials.gov/ct2/show/NCT02632695.",2020,"Across the three exercise levels, adherence did not differ between the two groups.","['Individuals With Chronic Venous Leg Ulcers', 'Individuals with venous leg ulcers (VLUs) suffer disproportionately with multiple chronic conditions', 'adults with VLUs were recruited from 2 wound centers in South Carolina, United States, and enrolled if they were aged 18 years or older with impaired functional mobility and an ankle-brachial index between 0.8 and 1.3', 'individuals with VLUs', 'A total of 24 patients']","['evidence-based, phased, nonexertive physical conditioning activities for lower leg function (FOOTFIT) or FOOTFIT+ with an added patient-provider communication feature', 'Leg Physical Activity Intervention', 'mobile health (mHealth) physical activity exercise']","['feasibility of reach, adherence, acceptability, implementation, and maintenance', 'Confidence limits']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C3266262', 'cui_str': 'Multiple chronic diseases'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037716', 'cui_str': 'South Carolina'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0230446', 'cui_str': 'Both lower legs'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",24.0,0.0958684,"Across the three exercise levels, adherence did not differ between the two groups.","[{'ForeName': 'Teresa J', 'Initials': 'TJ', 'LastName': 'Kelechi', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Prentice', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mueller', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Madisetti', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Alexey', 'Initials': 'A', 'LastName': 'Vertegel', 'Affiliation': 'Department of Bioengineering, Clemson University, Clemson, SC, United States.'}]",JMIR mHealth and uHealth,['10.2196/15015']
1495,32412097,Comparison of the efficacy of ECT plus agomelatine to ECT plus placebo in treatment-resistant depression.,"OBJECTIVE


Electroconvulsive therapy (ECT) is commonly used to treat patients with treatment-resistant depression. We aimed to investigate whether combining an antidepressant agent with ECT might enhance therapeutic efficacy and prevent early relapse.
METHODS


During the acute ECT phase, patients (N = 97) with treatment-resistant depression were randomized to receive ECT plus agomelatine 50 mg/d (n = 48) or ECT plus placebo (n =49). Symptom severity measures, including the 17-item Hamilton Depression Rating Scale (HAMD-17) and other scales, functional impairment, quality of life, neuropsychological tests, adverse events and attitudes toward ECT were assessed regularly. Remission was defined as a HAMD-17 score ≤ 7. If patients achieved post-ECT remission, they were prescribed agomelatine 50 mg/d and participated in a 12-week follow-up trial. HAMD-17 was rated at 4-week intervals. Relapse was defined as a HAMD-17 score ≥ 14, or rehospitalization for a psychiatric reason.
RESULTS


The two treatment groups were comparable at: 1) baseline variables, 2) score changes in all symptom measures, functional impairment, quality of life, and neuropsychological tests, 3) frequency of adverse events and attitudes toward ECT, and 4) post-ECT response/remission rates. There were no statistically significant differences following ECT in relapse rates and time to relapse between these two groups.
CONCLUSION


Adding agomelatine to ECT yielded comparable response/remission rates to ECT without agomelatine in the acute ECT phase. Starting agomelatine in combination with ECT did not seem to be more efficacious in preventing relapse than starting agomelatine after the acute ECT course. More research is needed to guide clinical recommendations.",2020,Starting agomelatine in combination with ECT did not seem to be more efficacious in preventing relapse than starting agomelatine after the acute ECT course.,"['patients with treatment-resistant depression', 'patients (N = 97) with treatment-resistant depression']","['ECT', 'ECT plus agomelatine to ECT plus placebo', 'ECT plus agomelatine', 'Electroconvulsive therapy (ECT', 'ECT plus placebo']","['17-item Hamilton Depression Rating Scale (HAMD-17) and other scales, functional impairment, quality of life, neuropsychological tests, adverse events and attitudes toward ECT', 'response/remission rates', 'Remission', 'Relapse', 'symptom measures, functional impairment, quality of life, and neuropsychological tests, 3) frequency of adverse events and attitudes toward ECT, and 4) post-ECT response/remission rates', 'relapse rates and time to relapse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0971637', 'cui_str': 'agomelatine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",97.0,0.124056,Starting agomelatine in combination with ECT did not seem to be more efficacious in preventing relapse than starting agomelatine after the acute ECT course.,"[{'ForeName': 'Ching-Hua', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': 'Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Wei-Cheng', 'Initials': 'WC', 'LastName': 'Yang', 'Affiliation': 'Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Cheng-Chung', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Wun-Ruei', 'Initials': 'WR', 'LastName': 'Cai', 'Affiliation': 'Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung, Taiwan.'}]",Acta psychiatrica Scandinavica,['10.1111/acps.13183']
1496,32411906,"A pilot study assessing the addition of a Quit and Win program to pharmacist-led intensive smoking cessation therapy in a predominantly underserved, minority population.","INTRODUCTION


Quit and Win programs (Q&W) have been shown to improve smoking cessation rates by offering potential rewards to encourage smoking cessation. However, few studies have combined Q&W with intensive smoking cessation programs including behavioral counseling and pharmacotherapy, or studied Q&W in underserved, minority populations. This study was conducted to assess the impact on smoking cessation rates of adding a Q&W to intensive smoking cessation therapy in a largely underserved, minority population.
METHODS


This was a single-center, prospective, open-label controlled study. Current smokers received pharmacist-led behavioral counseling and smoking cessation pharmacotherapy. Intervention group patients who successfully quit (verified by self-report and exhaled carbon monoxide) at 1 month and 3 months post-quit date were entered into a draw for $1000. The control group received the same smoking cessation services, but without a monetary incentive.
RESULTS


Enrollment was 111 patients (N=85 in the intervention group), made up of predominantly underserved (82% had annual household income <$25000), minority (69.1%), and female (58%) patients. Groups were similar except the intervention group had lower educational and income levels, while the control group was more likely to smoke more than 1 pack per day. Quit rates at 3 months were 27% and 19% in the intervention and control groups, respectively (p=0.22). Female gender (OR=2.84; p=0.04) and Fagerström score (OR=0.71; p<0.01) were significant predictors of quitting.
CONCLUSIONS


The addition of Q&W to intensive smoking cessation services increased clinic referrals and numerically improved cessation rates, although this difference was not statistically significant, possibly due to high attrition of the study.",2019,"Quit rates at 3 months were 27% and 19% in the intervention and control groups, respectively (p=0.22).","['111 patients (N=85 in the intervention group), made up of predominantly underserved (82% had annual household income <$25000), minority (69.1%), and female (58%) patients', 'Intervention group patients who successfully quit (verified by self-report and exhaled carbon monoxide) at 1 month and 3 months post-quit date were entered into a draw for $1000']","['same smoking cessation services, but without a monetary incentive', 'Q&W to intensive smoking cessation therapy', 'pharmacist-led behavioral counseling and smoking cessation pharmacotherapy', 'Quit and Win programs (Q&W', 'Quit and Win program to pharmacist-led intensive smoking cessation therapy']","['cessation rates', 'lower educational and income levels', 'smoking cessation rates', 'Fagerström score', 'Quit rates']","[{'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0557163', 'cui_str': 'Household income'}, {'cui': 'C4517664', 'cui_str': '25000'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C1883310', 'cui_str': '1000'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1095963', 'cui_str': 'Smoking cessation therapy'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0209548,"Quit rates at 3 months were 27% and 19% in the intervention and control groups, respectively (p=0.22).","[{'ForeName': 'Kirk E', 'Initials': 'KE', 'LastName': 'Evoy', 'Affiliation': 'College of Pharmacy, The University of Texas at Austin, Austin, Texas, United States.'}, {'ForeName': 'Kentya H', 'Initials': 'KH', 'LastName': 'Ford', 'Affiliation': 'College of Pharmacy, The University of Texas at Austin, Austin, Texas, United States.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Nduaguba', 'Affiliation': 'College of Pharmacy, The University of Texas at Austin, Austin, Texas, United States.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Taylor', 'Affiliation': 'Department of Pharmacy, University Health System, San Antonio, Texas, United States.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Thomas', 'Affiliation': 'Department of Pharmacy, University Health System, San Antonio, Texas, United States.'}]",Tobacco prevention & cessation,['10.18332/tpc/113356']
1497,32412085,Mind the social feedback: effects of tDCS applied to the left DLPFC on psychophysiological responses during the anticipation and reception of social evaluations.,"The left dorsolateral prefrontal cortex (lDLPFC) is implicated in anticipatory (i.e. during anticipation of emotional stimuli) and online (i.e. during confrontation with emotional stimuli) emotion regulatory processes. However, research that investigates the causal role of the lDLPFC in these processes is lacking. In this study, 74 participants received active or sham transcranial direct current stimulation (tDCS) over the lDLPFC. Participants were told strangers evaluated them. These (rigged) social evaluations were presented, and in 50% of the trials, participants could anticipate the valence (positive or negative) of the upcoming social feedback. Pupil dilation (a marker of cognitive resource allocation), and skin conductance responses (a marker of arousal) were measured. The results indicate that active (compared to sham) tDCS reduced arousal during the confrontation with anticipated feedback, but only marginally during the confrontation with unanticipated feedback. When participants were given the opportunity to anticipate the social feedback, tDCS reduced arousal, irrespective of whether one was anticipating or being confronted with the anticipated feedback. Moreover, tDCS reduced cognitive resource allocation during anticipation, which was associated with resource allocation increases during the subsequent confrontation. Altogether, results suggest that the lDLPFC is causally implicated in the interplay between anticipatory and online emotion regulatory processes.",2020,"Moreover, tDCS reduced cognitive resource allocation during anticipation, which was associated with resource allocation increases during the subsequent confrontation.",['74 participants received'],"['sham) tDCS', 'active or sham transcranial direct current stimulation (tDCS) over the lDLPFC', 'tDCS', 'lDLPFC']","['social feedback', 'cognitive resource allocation', 'Pupil dilation (a marker of cognitive resource allocation), and skin conductance responses (a marker of arousal', 'psychophysiological responses']",[],"[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0086914', 'cui_str': 'Allocation of Resources'}, {'cui': 'C0026961', 'cui_str': 'Dilated pupil'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}]",74.0,0.0328058,"Moreover, tDCS reduced cognitive resource allocation during anticipation, which was associated with resource allocation increases during the subsequent confrontation.","[{'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Allaert', 'Affiliation': 'Department of Head and Skin, Ghent University, University Hospital Ghent (UZ Ghent), Ghent, Belgium.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'De Raedt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Sanchez-Lopez', 'Affiliation': 'Department of Clinical Psychology, Universidad Complutense de Madrid, Spain.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Department of Head and Skin, Ghent University, University Hospital Ghent (UZ Ghent), Ghent, Belgium.'}, {'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Vanderhasselt', 'Affiliation': 'Department of Head and Skin, Ghent University, University Hospital Ghent (UZ Ghent), Ghent, Belgium.'}]",Social cognitive and affective neuroscience,['10.1093/scan/nsaa066']
1498,32412145,Mind and body: Psychophysiological profiles of instructional and motivational self-talk.,"Self-talk is a psychological skill that benefits motor performance by controlling and organizing performers' thoughts. While the behavioral effects of self-talk are clear, research on the mechanisms underpinning the effects of different modes of self-talk is sparse. To address this issue, we propose and test a psychophysiological model of the effects of self-talk on motor performance. Forty golf novices practiced a golf putting task while using either instructional or motivational self-talk preceding each putt. We measured performance (radial error), technique (club kinematics and muscle activity), cardiac activity (heart-rate and event-related heart-rate change), as well as electroencephalographic alpha power and connectivity in a randomized (group: instructional self-talk, motivational self-talk) experimental design. Instructional self-talk promoted superior technique and was associated with greater parietal alpha power and weaker connectivity between frontal and parietal electrodes and all other scalp sites, possibly indicative of increased top-down control of action. These findings provide initial evidence for an information-processing mechanism underlying the benefits of instructional self-talk. They also cast doubt on the validity of left-frontotemporal connectivity as a measure of verbal-analytic processing during motor tasks. Motivational self-talk led to increased heart-rate and reduced event-related heart rate variability, suggesting an effort-based mechanism to explain the benefits of motivational self-talk. Our study represents the most complete multi-measure investigation of self-talk to date. We hope that our psychophysiological model of self-talk will encourage researchers to move beyond the exclusive reliance on behavioral and self-report measures to discover the mechanisms underlying the benefits of self-talk for performance.",2020,"Instructional self-talk promoted superior technique and was associated with greater parietal alpha power and weaker connectivity between frontal and parietal electrodes and all other scalp sites, possibly indicative of increased top-down control of action.",[],['Mind and body'],"['instructional self-talk, motivational self-talk) experimental design', 'heart-rate', 'performance (radial error), technique (club kinematics and muscle activity), cardiac activity (heart-rate and event-related heart-rate change), as well as electroencephalographic alpha power and connectivity']",[],"[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443168', 'cui_str': 'Cardiac activity'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]",,0.0162807,"Instructional self-talk promoted superior technique and was associated with greater parietal alpha power and weaker connectivity between frontal and parietal electrodes and all other scalp sites, possibly indicative of increased top-down control of action.","[{'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bellomo', 'Affiliation': 'Bangor University, Bangor, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Cooke', 'Affiliation': 'Bangor University, Bangor, United Kingdom.'}, {'ForeName': 'Germano', 'Initials': 'G', 'LastName': 'Gallicchio', 'Affiliation': 'University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Ring', 'Affiliation': 'University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hardy', 'Affiliation': 'Bangor University, Bangor, United Kingdom.'}]",Psychophysiology,['10.1111/psyp.13586']
1499,32411907,"Does adding a psychosocial cessation intervention to an existing life-skills and tobacco-prevention program influence the use of tobacco and supari among secondary school students?: Findings from a quasi-experimental trial in Mumbai, India.","INTRODUCTION


This study aimed to test whether school-going adolescents who self-report tobacco and/or supari use are more likely to quit if a school-based psychosocial cessation intervention is added to an existing life-skills and tobacco-prevention program.
METHODS


A quasi-experimental trial with pre-test and post-test 20 weeks after the intervention was conducted with students from low-income families in 12 schools in Mumbai; six schools were randomly assigned to the intervention and the remaining to the comparison condition. Participants were students from grades 7, 8 and 9 who self-reported tobacco and/or supari use. Intervention schools received six sessions of LifeFirst, a psychosocial group-based tobacco cessation intervention program, in addition to SuperArmy, a school-wide life-skills and tobacco-prevention program. Trained counselors facilitated the cessation intervention, which spanned five months. All students in comparison schools received only SuperArmy. The outcome measures were self-reported use of tobacco-only, supari-only, and tobacco plus supari in the past 30 days.
RESULTS


The number of all users decreased by 19.1% in the intervention and 18.7% in the comparison schools at post-test. Although this reduction was significant (p<0.001) within each group, the difference between intervention and comparison schools was not significant. Further segregation by type of product used showed that for tobacco-only users there was a non-significant increase of 1.7% in intervention schools, and a significant 26.2% increase (p<0.001) in the comparison group. Tobacco plus supari use declined in both groups; however, supari-only use fell by 14.8% in the intervention and 32.7% in the comparison schools (p<0.01).
CONCLUSIONS


The combination of a cessation intervention along with the life-skills and tobacco-prevention program appear to have halted tobacco-only use in the intervention group. Future research needs to determine whether students are substituting supari for tobacco and to understand the psychological mechanisms underlying the cessation intervention and the interaction between cessation and prevention-only interventions.",2019,"Tobacco plus supari use declined in both groups; however, supari-only use fell by 14.8% in the intervention and 32.7% in the comparison schools (p<0.01).
","['students from low-income families in 12 schools in Mumbai; six schools', 'Participants were students from grades 7, 8 and 9 who self-reported tobacco and/or supari use', 'school-going adolescents who self-report tobacco and/or supari use']","['six sessions of LifeFirst, a psychosocial group-based tobacco cessation intervention program, in addition to SuperArmy, a school-wide life-skills and tobacco-prevention program', 'psychosocial cessation intervention']","['self-reported use of tobacco-only, supari-only, and tobacco plus supari in the past 30 days', 'number of all users']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.0229802,"Tobacco plus supari use declined in both groups; however, supari-only use fell by 14.8% in the intervention and 32.7% in the comparison schools (p<0.01).
","[{'ForeName': 'Nilesh', 'Initials': 'N', 'LastName': 'Chatterjee', 'Affiliation': 'Salaam Bombay Foundation, Mumbai, India.'}, {'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Gupte', 'Affiliation': 'Narotam Sekhsaria Foundation, Mumbai, India.'}, {'ForeName': 'Gauri', 'Initials': 'G', 'LastName': 'Mandal', 'Affiliation': 'Salaam Bombay Foundation, Mumbai, India.'}, {'ForeName': 'Tshering', 'Initials': 'T', 'LastName': 'Bhutia', 'Affiliation': 'Salaam Bombay Foundation, Mumbai, India.'}]",Tobacco prevention & cessation,['10.18332/tpc/113355']
1500,32412119,Magnetic resonance imaging guided cryoballoon ablation for left atrial substrate modification in patients with atrial fibrillation.,"BACKGROUND


Cryoballoon ablation (CBA) for pulmonary vein isolation (PVI) is an established modality for the treatment of atrial fibrillation (AF). We report feasibility of left atrial (LA) substrate modification in addition to PVI both using the cryoballoon.
METHODS


Left atrial substrates and CBA-induced scar were assessed at baseline and 3 months post-ablation using late gadolinium enhancement magnetic resonance imaging (LGE-MRI). Common peri-procedural data including post-ablation LGE-MRI for evaluation of esophageal thermal injury, and CBA-associated complications were collected. Freedom from AF recurrence at 12 months was assessed using Holter and 30-day rhythm monitors.
RESULTS


In 26 patients (64 ±11 years; 69% male; 27% persistent AF; CHADSVASC score 2.3 ±1.5; LVEF 56 ±10%; OAC with Warfarin/DOAC n=11/15), referred for first time AF ablation, CBA of the pulmonary veins (PVs) and extra-pulmonary LA substrates was performed (median 12 [IQR 7-14] freezes over 1675 secs [IQR 1168-2160]). On LGE-MRI significant post-ablation cryoballoon-induced LA scar (median 19.4% [IQR 13.4-24.7] in comparison to baseline pre-ablation LA-LGE (median 10.6% [IQR 3.1-13.1], p=0.01) was found. Freedom from AF recurrence at 12 months was 74.5% with median time-to-recurrence of 242 days [IQR 172-298]. In 15/26 patients (58%) esophageal enhancement on the post-ablation MRI was present with full recovery after three months. No major periprocedural complications were observed.
CONCLUSION


Left atrial substrate modification in addition to PVI using LGE-MRI-guided cryoballoon ablation is feasible but still experimental. The efficacy and safety have to be investigated in a prospective randomized trial. This article is protected by copyright. All rights reserved.",2020,Freedom from AF recurrence at 12 months was 74.5% with median time-to-recurrence of 242 days [IQR 172-298].,['patients with atrial fibrillation'],"['Magnetic resonance imaging guided cryoballoon ablation', 'left atrial (LA) substrate modification', 'gadolinium enhancement magnetic resonance imaging (LGE-MRI', 'Cryoballoon ablation (CBA']","['efficacy and safety', 'periprocedural complications', 'LA scar']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1141861', 'cui_str': 'Procedural complication'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}]",,0.0574296,Freedom from AF recurrence at 12 months was 74.5% with median time-to-recurrence of 242 days [IQR 172-298].,"[{'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Kirstein', 'Affiliation': 'Herzzentrum Dresden, Universitätsklinik an der TU Dresden, Department of Electrophysiology, Fetscherstrasse 76, 01307, Dresden, Germany.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Morris', 'Affiliation': 'Comprehensive Arrhythmia Research and Management (CARMA) Center, University of Utah, Division of Cardiovascular Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Baher', 'Affiliation': 'Comprehensive Arrhythmia Research and Management (CARMA) Center, University of Utah, Division of Cardiovascular Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Ibolya', 'Initials': 'I', 'LastName': 'Csécs', 'Affiliation': 'Comprehensive Arrhythmia Research and Management (CARMA) Center, University of Utah, Division of Cardiovascular Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Mobin', 'Initials': 'M', 'LastName': 'Kheirkhahan', 'Affiliation': 'Comprehensive Arrhythmia Research and Management (CARMA) Center, University of Utah, Division of Cardiovascular Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Gagandeep', 'Initials': 'G', 'LastName': 'Kaur', 'Affiliation': 'Comprehensive Arrhythmia Research and Management (CARMA) Center, University of Utah, Division of Cardiovascular Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Kholmovski', 'Affiliation': 'Comprehensive Arrhythmia Research and Management (CARMA) Center, University of Utah, Division of Cardiovascular Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Nassir F', 'Initials': 'NF', 'LastName': 'Marrouche', 'Affiliation': 'Comprehensive Arrhythmia Research and Management (CARMA) Center, University of Utah, Division of Cardiovascular Medicine, Salt Lake City, Utah, USA.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14551']
1501,32412195,[Locoregional anesthesia in endoscopic surgery of intracerebral hypertensive hemangiomas].,"Introduction


Currently, minimally invasive methods of surgical treatment of hypertensive intracerebral hematomas (ICHs) are actively used. However, anesthetic management of these surgeries are unclear. Moreover, advisability of locoregional anesthesia (LRA) for endoscopic aspiration of hypertensive ICHs has not been studied.
Objective


To analyze application of regional anesthesia in minimally invasive surgery of hypertensive intracerebral hematomas.
Material and methods


Patients were divided into 2 groups. Group 1 included 45 patients who underwent surgery under total intravenous anesthesia with mechanical ventilation (TIVA + mechanical ventilation), group 2 (n=43) - surgery under LRA. The incidence of pneumonia and postoperative outcomes in accordance with the GOS grading system were analyzed depending on the method of anesthesia.
Results


Pneumonia was 3 times more common in the first group (33%) that required prolonged ventilation and tracheostomy. Thus, there were 9 tracheostomies (20%) in the first group. In the second group, one patient required mechanical ventilation on the second postoperative day due to severe chronic obstructive pulmonary disease followed by deterioration of respiratory failure. Tracheostomy was also performed in this case. According to analysis of GOS outcomes, the LRA group was characterized by 4 times lower mortality and 1.5 times greater number of patients with good recovery and moderate disabilities compared with the first group.
Conclusions


LRA is a feasible and effective method for the anesthetic management of minimally invasive surgery in patients with hypertensive ICHs. This approach ensures decrease of mortality rate, increase of good neurological outcomes and reduce pulmonary infectious complications.",2020,"According to analysis of GOS outcomes, the LRA group was characterized by 4 times lower mortality and 1.5 times greater number of patients with good recovery and moderate disabilities compared with the first group.
","['45 patients who underwent', 'minimally invasive surgery of hypertensive intracerebral hematomas', 'intracerebral hypertensive hemangiomas', 'hypertensive intracerebral hematomas (ICHs', 'patients with hypertensive ICHs']","['Locoregional anesthesia', 'regional anesthesia', 'mechanical ventilation', 'surgery under total intravenous anesthesia with mechanical ventilation (TIVA + mechanical ventilation), group 2 (n=43) - surgery under LRA']","['severe chronic obstructive pulmonary disease followed by deterioration of respiratory failure', 'pulmonary infectious complications', 'mortality rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0021870', 'cui_str': 'Intracerebral hematoma'}, {'cui': 'C0442111', 'cui_str': 'Intracerebral'}, {'cui': 'C0018916', 'cui_str': 'Hemangioma'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}, {'cui': 'C3854651', 'cui_str': 'TIVA'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",45.0,0.0176614,"According to analysis of GOS outcomes, the LRA group was characterized by 4 times lower mortality and 1.5 times greater number of patients with good recovery and moderate disabilities compared with the first group.
","[{'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Tsilina', 'Affiliation': 'City Clinical Emergency Hospital No. 1, Omsk, Russia.'}, {'ForeName': 'Ya A', 'Initials': 'YA', 'LastName': 'Shesterikov', 'Affiliation': 'City Clinical Emergency Hospital No. 1, Omsk, Russia.'}, {'ForeName': 'V G', 'Initials': 'VG', 'LastName': 'Dashyan', 'Affiliation': 'A.I. Evdokimov Moscow State Medical and Dental University, Moscow, Russia.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Petrikov', 'Affiliation': 'A.I. Evdokimov Moscow State Medical and Dental University, Moscow, Russia.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Govorova', 'Affiliation': 'Omsk State Medical University, Omsk, Russia.'}]",Zhurnal voprosy neirokhirurgii imeni N. N. Burdenko,['10.17116/neiro20208402165']
1502,32412181,Live lectures and videos do not differ in relation to learning outcomes of dental ergonomics.,"OBJECTIVES


This study aimed to compare the knowledge attained by third-year dental students in physical ergonomics altering live lectures and videos in teaching. The second aim was to investigate implementation of the theoretical knowledge on ergonomics into practice.
MATERIAL AND METHODS


Forty-five students divided into two groups attended a live lecture (45 min) or viewed videos (45 min). After the first teaching session, the groups changed parts. All students answered a questionnaire with 13 true or false-questions on ergonomics at baseline and immediately after both teaching sessions. Friedman's test and Wilcoxon signed rank test were used to compare questionnaire scores of the student groups. Additionally, we photographed 17 randomly selected students 3 months after baseline during a simulation workshop on endodontics. We analyzed the photographs for ergonomic postures using a specific 12-point checklist.
RESULTS


At baseline, no difference in the knowledge between the two groups was discovered, when both scored 72%. After the first teaching session, significant improvement in both groups (p < .05) was found; and there was no statistically significant difference in the scores between the groups (88% in the lecture-first and 82% in the video-first group). After the second teaching session, the scores were similar in both groups. Overall all improvement in both groups was significant (p < .001). The photograph analysis showed half of the postures being in accord with the ergonomic guidelines.
CONCLUSIONS


Both live lectures and videos showed similar outcomes in teaching ergonomics. Implementation of the knowledge on ergonomics is insufficient. Videos provide an easy-to-organize alternative to live lectures in teaching dental ergonomics. New means are needed to have dental students implement their knowledge on ergonomics into practice.",2020,"After the first teaching session, significant improvement in both groups (p < .05) was found; and there was no statistically significant difference in the scores between the groups (88% in the lecture-first and 82% in the video-first group).","['Forty-five students divided into two groups attended a', 'third-year dental students in physical ergonomics altering live lectures and videos in teaching']",['live lecture (45\u2009min) or viewed videos'],['questionnaire scores'],"[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C4505395', 'cui_str': 'Physical Ergonomics'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0039401', 'cui_str': 'Education'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",17.0,0.0185547,"After the first teaching session, significant improvement in both groups (p < .05) was found; and there was no statistically significant difference in the scores between the groups (88% in the lecture-first and 82% in the video-first group).","[{'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Leinonen', 'Affiliation': 'Department of Clinical Dentistry, UiT The Arctic University of Norway, Tromso, Norway.'}, {'ForeName': 'Marja-Liisa', 'Initials': 'ML', 'LastName': 'Laitala', 'Affiliation': 'Department of Clinical Dentistry, UiT The Arctic University of Norway, Tromso, Norway.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Pirttilahti', 'Affiliation': 'Department of Clinical Dentistry, UiT The Arctic University of Norway, Tromso, Norway.'}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Niskanen', 'Affiliation': 'Department of Clinical Dentistry, UiT The Arctic University of Norway, Tromso, Norway.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Pesonen', 'Affiliation': 'Infrastructure for Population Studies, Faculty of Medicine, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Vuokko', 'Initials': 'V', 'LastName': 'Anttonen', 'Affiliation': 'Department of Clinical Dentistry, UiT The Arctic University of Norway, Tromso, Norway.'}]",Clinical and experimental dental research,['10.1002/cre2.300']
1503,32412273,Eliminating Leakage Errors in Hyperfine Qubits.,"Population leakage outside the qubit subspace presents a particularly harmful source of error that cannot be handled by standard error correction methods. Using a trapped ^{171}Yb^{+} ion, we demonstrate an optical pumping scheme to suppress leakage errors in atomic hyperfine qubits. The selection rules and narrow linewidth of a quadrupole transition are used to selectively pump population out of leakage states and back into the qubit subspace. Each pumping cycle reduces the leakage population by a factor of ∼3, allowing for an exponential suppression in the number of cycles. We use interleaved randomized benchmarking on the qubit subspace to show that this pumping procedure has negligible side effects on the qubit subspace, bounding the induced qubit memory error by ≤2.0(8)×10^{-5}  per cycle, and qubit population decay to ≤1.4(3)×10^{-7}  per cycle. These results clear a major obstacle for implementations of quantum error correction and error mitigation protocols.",2020,"Each pumping cycle reduces the leakage population by a factor of ∼3, allowing for an exponential suppression in the number of cycles.",[],['trapped ^{171}Yb'],[],[],"[{'cui': 'C1275126', 'cui_str': 'TNF receptor-associated periodic fever syndrome (TRAPS)'}]",[],,0.0471514,"Each pumping cycle reduces the leakage population by a factor of ∼3, allowing for an exponential suppression in the number of cycles.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hayes', 'Affiliation': 'Honeywell Quantum Solutions, 303 S. Technology Ct. 80021 Broomfield, Colorado, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stack', 'Affiliation': 'Honeywell Quantum Solutions, 303 S. Technology Ct. 80021 Broomfield, Colorado, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bjork', 'Affiliation': 'Honeywell Quantum Solutions, 303 S. Technology Ct. 80021 Broomfield, Colorado, USA.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Potter', 'Affiliation': 'Honeywell Quantum Solutions, 303 S. Technology Ct. 80021 Broomfield, Colorado, USA.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Baldwin', 'Affiliation': 'Honeywell Quantum Solutions, 303 S. Technology Ct. 80021 Broomfield, Colorado, USA.'}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Stutz', 'Affiliation': 'Honeywell Quantum Solutions, 303 S. Technology Ct. 80021 Broomfield, Colorado, USA.'}]",Physical review letters,['10.1103/PhysRevLett.124.170501']
1504,28754483,"Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial.","BACKGROUND


Olaparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, has previously shown efficacy in a phase 2 study when given in capsule formulation to all-comer patients with platinum-sensitive, relapsed high-grade serous ovarian cancer. We aimed to confirm these findings in patients with a BRCA1 or BRCA2 (BRCA1/2) mutation using a tablet formulation of olaparib.
METHODS


This international, multicentre, double-blind, randomised, placebo-controlled, phase 3 trial evaluated olaparib tablet maintenance treatment in platinum-sensitive, relapsed ovarian cancer patients with a BRCA1/2 mutation who had received at least two lines of previous chemotherapy. Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance status at baseline of 0-1 and histologically confirmed, relapsed, high-grade serous ovarian cancer or high-grade endometrioid cancer, including primary peritoneal or fallopian tube cancer. Patients were randomly assigned 2:1 to olaparib (300 mg in two 150 mg tablets, twice daily) or matching placebo tablets using an interactive voice and web response system. Randomisation was stratified by response to previous platinum chemotherapy (complete vs partial) and length of platinum-free interval (6-12 months vs ≥12 months) and treatment assignment was masked for patients, those giving the interventions, data collectors, and data analysers. The primary endpoint was investigator-assessed progression-free survival and we report the primary analysis from this ongoing study. The efficacy analyses were done on the intention-to-treat population; safety analyses included patients who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov, number NCT01874353, and is ongoing and no longer recruiting patients.
FINDINGS


Between Sept 3, 2013, and Nov 21, 2014, we enrolled 295 eligible patients who were randomly assigned to receive olaparib (n=196) or placebo (n=99). One patient in the olaparib group was randomised in error and did not receive study treatment. Investigator-assessed median progression-free survival was significantly longer with olaparib (19·1 months [95% CI 16·3-25·7]) than with placebo (5·5 months [5·2-5·8]; hazard ratio [HR] 0·30 [95% CI 0·22-0·41], p<0·0001). The most common adverse events of grade 3 or worse severity were anaemia (38 [19%] of 195 patients in the olaparib group vs two [2%] of 99 patients in the placebo group), fatigue or asthenia (eight [4%] vs two [2%]), and neutropenia (ten [5%] vs four [4%]). Serious adverse events were experienced by 35 (18%) patients in the olaparib group and eight (8%) patients in the placebo group. The most common in the olaparib group were anaemia (seven [4%] patients), abdominal pain (three [2%] patients), and intestinal obstruction (three [2%] patients). The most common in the placebo group were constipation (two [2%] patients) and intestinal obstruction (two [2%] patients). One (1%) patient in the olaparib group had a treatment-related adverse event (acute myeloid leukaemia) with an outcome of death.
INTERPRETATION


Olaparib tablet maintenance treatment provided a significant progression-free survival improvement with no detrimental effect on quality of life in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation. Apart from anaemia, toxicities with olaparib were low grade and manageable.
FUNDING


AstraZeneca.",2017,"INTERPRETATION


Olaparib tablet maintenance treatment provided a significant progression-free survival improvement with no detrimental effect on quality of life in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation.","['patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation', 'Between Sept 3, 2013, and Nov 21, 2014', 'patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21', 'Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance status at baseline of 0-1 and histologically confirmed, relapsed, high-grade serous ovarian cancer or high-grade endometrioid cancer, including primary peritoneal or fallopian tube cancer', '295 eligible patients', 'patients with a BRCA1 or BRCA2 (BRCA1/2) mutation using a tablet formulation of olaparib', 'patients with platinum-sensitive, relapsed high-grade serous ovarian cancer', 'platinum-sensitive, relapsed ovarian cancer patients with a BRCA1/2 mutation who had received at least two lines of previous chemotherapy']","['olaparib (300 mg in two 150 mg tablets, twice daily) or matching placebo tablets using an interactive voice and web response system', 'olaparib', 'Olaparib tablets', 'placebo']","['intestinal obstruction', 'fatigue or asthenia', 'anaemia', 'abdominal pain', 'Investigator-assessed median progression-free survival', 'constipation', 'neutropenia', 'quality of life', 'investigator-assessed progression-free survival', 'Serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0440743', 'cui_str': 'Serous (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}, {'cui': 'C0238122', 'cui_str': 'Fallopian Tube Cancer'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0021843', 'cui_str': 'Intestinal Obstruction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0034380'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",295.0,0.730915,"INTERPRETATION


Olaparib tablet maintenance treatment provided a significant progression-free survival improvement with no detrimental effect on quality of life in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation.","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Pujade-Lauraine', 'Affiliation': 'Medical Oncology Department, Université Paris Descartes, AP-HP, Paris, France. Electronic address: epujade@arcagy.org.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'Department of Oncology, University College London, London, UK.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Selle', 'Affiliation': 'Hôpital Tenon, Paris, France.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': 'Department of Biostatistics and Research Methodology, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Penson', 'Affiliation': 'Department of Hematology/Oncology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Oza', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Canada.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Korach', 'Affiliation': 'Gynecologic Oncology Department, Sheba Medical Center, Tel Aviv University, Tel Hashomer, Israel.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Huzarski', 'Affiliation': 'Department of Genetics and Pathology, Pomeranian Medical University, Szczecin, Poland.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Poveda', 'Affiliation': 'Instituto Valenciano de Oncología, Valencia, Spain.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Pignata', 'Affiliation': 'Istituto Tumori Pascale di Napoli, Naples, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Friedlander', 'Affiliation': 'Department of Medical Oncology, University of New South Wales Clinical School, Prince of Wales Hospital, Randwick, NSW, Australia.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'Gynecology Department, University of Milan-Bicocca and Istituto Europeo Oncología, Milan, Italy.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Harter', 'Affiliation': 'Department of Gynecology and Gynecologic Oncology, Kliniken Essen Mitte, Essen, Germany.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Saitama, Japan.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ray-Coquard', 'Affiliation': 'Medical Oncology Department, Centre Léon Bérard and University Claude Bernard, Lyon, France.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Lowe', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Bloomfield', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Pautier', 'Affiliation': 'Gustave Roussy Cancer Campus, Villejuif, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(17)30469-2']
1505,28781171,"First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global): a combined analysis of three multicentre, randomised, phase 3 trials.","BACKGROUND


Data suggest selective internal radiotherapy (SIRT) in third-line or subsequent therapy for metastatic colorectal cancer has clinical benefit in patients with colorectal liver metastases with liver-dominant disease after chemotherapy. The FOXFIRE, SIRFLOX, and FOXFIRE-Global randomised studies evaluated the efficacy of combining first-line chemotherapy with SIRT using yttrium-90 resin microspheres in patients with metastatic colorectal cancer with liver metastases. The studies were designed for combined analysis of overall survival.
METHODS


FOXFIRE, SIRFLOX, and FOXFIRE-Global were randomised, phase 3 trials done in hospitals and specialist liver centres in 14 countries worldwide (Australia, Belgium, France, Germany, Israel, Italy, New Zealand, Portugal, South Korea, Singapore, Spain, Taiwan, the UK, and the USA). Chemotherapy-naive patients with metastatic colorectal cancer (WHO performance status 0 or 1) with liver metastases not suitable for curative resection or ablation were randomly assigned (1:1) to either oxaliplatin-based chemotherapy (FOLFOX: leucovorin, fluorouracil, and oxaliplatin) or FOLFOX plus single treatment SIRT concurrent with cycle 1 or 2 of chemotherapy. In FOXFIRE, FOLFOX chemotherapy was OxMdG (oxaliplatin modified de Gramont chemotherapy; 85 mg/m 2  oxaliplatin infusion over 2 h, L-leucovorin 175 mg or D,L-leucovorin 350 mg infusion over 2 h, and 400 mg/m 2  bolus fluorouracil followed by a 2400 mg/m 2  continuous fluorouracil infusion over 46 h). In SIRFLOX and FOXFIRE-Global, FOLFOX chemotherapy was modified FOLFOX6 (85 mg/m 2  oxaliplatin infusion over 2 h, 200 mg leucovorin, and 400 mg/m 2  bolus fluorouracil followed by a 2400 mg/m 2  continuous fluorouracil infusion over 46 h). Randomisation was done by central minimisation with four factors: presence of extrahepatic metastases, tumour involvement of the liver, planned use of a biological agent, and investigational centre. Participants and investigators were not masked to treatment. The primary endpoint was overall survival, analysed in the intention-to-treat population, using a two-stage meta-analysis of pooled individual patient data. All three trials have completed 2 years of follow-up. FOXFIRE is registered with the ISRCTN registry, number ISRCTN83867919. SIRFLOX and FOXFIRE-Global are registered with ClinicalTrials.gov, numbers NCT00724503 (SIRFLOX) and NCT01721954 (FOXFIRE-Global).
FINDINGS


Between Oct 11, 2006, and Dec 23, 2014, 549 patients were randomly assigned to FOLFOX alone and 554 patients were assigned FOLFOX plus SIRT. Median follow-up was 43·3 months (IQR 31·6-58·4). There were 411 (75%) deaths in 549 patients in the FOLFOX alone group and 433 (78%) deaths in 554 patients in the FOLFOX plus SIRT group. There was no difference in overall survival (hazard ratio [HR] 1·04, 95% CI 0·90-1·19; p=0·61). The median survival time in the FOLFOX plus SIRT group was 22·6 months (95% CI 21·0-24·5) compared with 23·3 months (21·8-24·7) in the FOLFOX alone group. In the safety population containing patients who received at least one dose of study treatment, as treated, the most common grade 3-4 adverse event was neutropenia (137 [24%] of 571 patients receiving FOLFOX alone vs 186 (37%) of 507 patients receiving FOLFOX plus SIRT). Serious adverse events of any grade occurred in 244 (43%) of 571 patients receiving FOLFOX alone and 274 (54%) of 507 patients receiving FOLFOX plus SIRT. 10 patients in the FOLFOX plus SIRT group and 11 patients in the FOLFOX alone group died due to an adverse event; eight treatment-related deaths occurred in the FOLFOX plus SIRT group and three treatment-related deaths occurred in the FOLFOX alone group.
INTERPRETATION


Addition of SIRT to first-line FOLFOX chemotherapy for patients with liver-only and liver-dominant metastatic colorectal cancer did not improve overall survival compared with that for FOLFOX alone. Therefore, early use of SIRT in combination with chemotherapy in unselected patients with metastatic colorectal cancer cannot be recommended. To further define the role of SIRT in metastatic colorectal cancer, careful patient selection and studies investigating the role of SIRT as consolidation therapy after chemotherapy are needed.
FUNDING


Bobby Moore Fund of Cancer Research UK, Sirtex Medical.",2017,There was no difference in overall survival (hazard ratio [HR],"['naive patients with metastatic colorectal cancer (WHO performance status 0 or 1) with liver metastases not suitable for curative resection or ablation', 'patients with metastatic colorectal cancer with liver metastases', 'patients with liver-only and liver-dominant metastatic colorectal cancer', 'unselected patients with metastatic colorectal cancer', 'patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global', 'Between Oct 11, 2006, and Dec 23, 2014, 549 patients', 'FOXFIRE, SIRFLOX, and FOXFIRE-Global were randomised, phase 3 trials done in hospitals and specialist liver centres in 14 countries worldwide (Australia, Belgium, France, Germany, Israel, Italy, New Zealand, Portugal, South Korea, Singapore, Spain, Taiwan, the UK, and the USA', 'patients with colorectal liver metastases with liver-dominant disease after chemotherapy']","['selective internal radiotherapy (SIRT', 'leucovorin, and 400 mg/m 2  bolus fluorouracil', 'Chemotherapy', 'FOLFOX', 'oxaliplatin infusion over 2 h, L-leucovorin 175 mg or D,L-leucovorin', 'oxaliplatin-based chemotherapy (FOLFOX: leucovorin, fluorouracil, and oxaliplatin) or FOLFOX plus single treatment SIRT concurrent with cycle 1 or 2 of chemotherapy', 'FOXFIRE, FOLFOX chemotherapy was OxMdG (oxaliplatin modified de Gramont chemotherapy', 'FOLFOX plus SIRT', 'oxaliplatin', 'First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone', 'SIRT in combination with chemotherapy']","['median survival time', 'neutropenia', 'overall survival (hazard ratio [HR', 'deaths', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0032729', 'cui_str': 'Portuguese Republic'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0555352', 'cui_str': 'Internal radiotherapy'}, {'cui': 'C1136177', 'cui_str': 'SIRTs'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",549.0,0.103477,There was no difference in overall survival (hazard ratio [HR],"[{'ForeName': 'Harpreet S', 'Initials': 'HS', 'LastName': 'Wasan', 'Affiliation': 'Imperial College Healthcare NHS Trust and Imperial College, Hammersmith Hospital, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gibbs', 'Affiliation': 'Western Hospital, Footscray, VIC, Australia.'}, {'ForeName': 'Navesh K', 'Initials': 'NK', 'LastName': 'Sharma', 'Affiliation': 'Division of Radiation Oncology, Penn State Hershey Cancer Centre, School of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Taieb', 'Affiliation': 'Sorbonne Paris Cité, Université Paris Descartes, Georges Pompidou European Hospital, Department of Hepatogastroenterology and GI Oncology, Paris, France.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medical Oncology and Comprehensive Cancer Centre, Klinikum Grosshadern, Ludwig-Maximilian, University of Munich, Munich, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Ricke', 'Affiliation': 'Department of Radiology and Nuclear Medicine, University of Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': 'Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Findlay', 'Affiliation': 'Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Weaver', 'Affiliation': 'Oxford University NHS Foundation Trust, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Mills', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham City Hospital, Nottingham, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Wilson', 'Affiliation': ""Cambridge University Hospitals NHS Trust, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Adams', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Francis', 'Affiliation': 'Oncology Clinical Trials Office, Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Moschandreas', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Pradeep S', 'Initials': 'PS', 'LastName': 'Virdee', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dutton', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Love', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'van Hazel', 'Affiliation': 'School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Ricky A', 'Initials': 'RA', 'LastName': 'Sharma', 'Affiliation': 'Cancer Research UK Medical Research Council (CRUK-MRC) Oxford Institute for Radiation Oncology, University of Oxford, Oxford, UK; National Institute for Health Research University College London Hospitals Biomedical Research Centre, UCL Cancer Institute, London, UK. Electronic address: ricky.sharma@oncology.ox.ac.uk.'}]",The Lancet. Oncology,['10.1016/S1470-2045(17)30457-6']
1506,28784312,"Neoadjuvant cisplatin and fluorouracil versus epirubicin, cisplatin, and capecitabine followed by resection in patients with oesophageal adenocarcinoma (UK MRC OE05): an open-label, randomised phase 3 trial.","BACKGROUND


Neoadjuvant chemotherapy before surgery improves survival compared with surgery alone for patients with oesophageal cancer. The OE05 trial assessed whether increasing the duration and intensity of neoadjuvant chemotherapy further improved survival compared with the current standard regimen.
METHODS


OE05 was an open-label, phase 3, randomised clinical trial. Patients with surgically resectable oesophageal adenocarcinoma classified as stage cT1N1, cT2N1, cT3N0/N1, or cT4N0/N1 were recruited from 72 UK hospitals. Eligibility criteria included WHO performance status 0 or 1, adequate respiratory, cardiac, and liver function, white blood cell count at least 3 × 10 9  cells per L, platelet count at least 100 × 10 9  platelets per L, and a glomerular filtration rate at least 60 mL/min. Participants were randomly allocated (1:1) using a computerised minimisation program with a random element and stratified by centre and tumour stage, to receive two cycles of cisplatin and fluorouracil (CF; two 3-weekly cycles of cisplatin [80 mg/m 2  intravenously on day 1] and fluorouracil [1 g/m 2  per day intravenously on days 1-4]) or four cycles of epirubicin, cisplatin, and capecitabine (ECX; four 3-weekly cycles of epirubicin [50 mg/m 2 ] and cisplatin [60 mg/m 2 ] intravenously on day 1, and capecitabine [1250 mg/m 2 ] daily throughout the four cycles) before surgery, stratified according to centre and clinical disease stage. Neither patients nor study staff were masked to treatment allocation. Two-phase oesophagectomy with two-field (abdomen and thorax) lymphadenectomy was done within 4-6 weeks of completion of chemotherapy. The primary outcome measure was overall survival, and primary and safety analyses were done in the intention-to-treat population. This trial is registered with the ISRCTN registry (number 01852072) and ClinicalTrials.gov (NCT00041262), and is completed.
FINDINGS


Between Jan 13, 2005, and Oct 31, 2011, 897 patients were recruited and 451 were assigned to the CF group and 446 to the ECX group. By Nov 14, 2016, 327 (73%) of 451 patients in the CF group and 302 (68%) of 446 in the ECX group had died. Median survival was 23·4 months (95% CI 20·6-26·3) with CF and 26·1 months (22·5-29·7) with ECX (hazard ratio 0·90 (95% CI 0·77-1·05, p=0·19). No unexpected chemotherapy toxicity was seen, and neutropenia was the most commonly reported event (grade 3 or 4 neutropenia: 74 [17%] of 446 patients in the CF group vs 101 [23%] of 441 people in the ECX group). The proportions of patients with postoperative complications (224 [56%] of 398 people for whom data were available in the CF group and 233 [62%] of 374 in the ECX group; p=0·089) were similar between the two groups. One patient in the ECX group died of suspected treatment-related neutropenic sepsis.
INTERPRETATION


Four cycles of neoadjuvant ECX compared with two cycles of CF did not increase survival, and cannot be considered standard of care. Our study involved a large number of centres and detailed protocol with comprehensive prospective assessment of health-related quality of life in a patient population confined to people with adenocarcinomas of the oesophagus and gastro-oesophageal junction (Siewert types 1 and 2). Alternative chemotherapy regimens and neoadjuvant chemoradiation are being investigated to improve outcomes for patients with oesophageal carcinoma.
FUNDING


Cancer Research UK and Medical Research Council Clinical Trials Unit at University College London.",2017,Median survival was 23·4 months (95% CI 20·6-26·3) with CF and 26·1 months (22·5-29·7) with ECX (hazard ratio 0·90,"['patients with oesophageal cancer', 'patients with oesophageal adenocarcinoma (UK MRC OE05', 'Between Jan 13, 2005, and Oct 31, 2011, 897 patients were recruited and 451 were assigned to the CF group and 446 to the ECX group', 'patient population confined to people with adenocarcinomas of the oesophagus and gastro-oesophageal junction (Siewert types 1 and 2', 'Patients with surgically resectable oesophageal adenocarcinoma classified as stage cT1N1, cT2N1, cT3N0/N1, or cT4N0/N1 were recruited from 72 UK hospitals', 'patients with oesophageal carcinoma']","['Neoadjuvant cisplatin and fluorouracil versus epirubicin, cisplatin, and capecitabine', 'Alternative chemotherapy regimens and neoadjuvant chemoradiation', 'cisplatin and fluorouracil (CF; two 3-weekly cycles of cisplatin [80 mg/m 2  intravenously on day 1] and fluorouracil', 'Two-phase oesophagectomy with two-field (abdomen and thorax) lymphadenectomy', 'ECX', 'epirubicin, cisplatin, and capecitabine (ECX; four 3-weekly cycles of epirubicin [50 mg/m 2 ] and cisplatin [60 mg/m 2 ] intravenously on day 1, and capecitabine ']","['Median survival', 'survival', 'WHO performance status 0 or 1, adequate respiratory, cardiac, and liver function, white blood cell count', 'chemotherapy toxicity', 'postoperative complications', 'died', 'neutropenia', 'overall survival, and primary and safety analyses', 'glomerular filtration rate', 'died of suspected treatment-related neutropenic sepsis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}, {'cui': 'C0279628', 'cui_str': 'Adenocarcinoma Of Esophagus'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0014876', 'cui_str': 'Esophagus'}, {'cui': 'C0014871', 'cui_str': 'Gastroesophageal Junction'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0152018', 'cui_str': 'Carcinoma of esophagus (disorder)'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877153', 'cui_str': 'Neutropenic sepsis'}]",897.0,0.295269,Median survival was 23·4 months (95% CI 20·6-26·3) with CF and 26·1 months (22·5-29·7) with ECX (hazard ratio 0·90,"[{'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Alderson', 'Affiliation': 'Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK. Electronic address: david.cunningham@rmh.nhs.uk.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Nankivell', 'Affiliation': 'Medical Research Council Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Blazeby', 'Affiliation': 'Centre for Surgical Research, University of Bristol, Bristol and University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'S Michael', 'Initials': 'SM', 'LastName': 'Griffin', 'Affiliation': 'The Northern Oesophago-Gastric Cancer Unit, Royal Victoria Infirmary, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Crellin', 'Affiliation': 'Leeds Teaching Hospital NHS Trust, Leeds, UK.'}, {'ForeName': 'Heike I', 'Initials': 'HI', 'LastName': 'Grabsch', 'Affiliation': 'Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK; Department of Pathology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Langer', 'Affiliation': 'University of Bern, Bern, Germany.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Pritchard', 'Affiliation': 'University Hospital South Manchester, Manchester, UK.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Okines', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Krysztopik', 'Affiliation': 'Royal United Hospital, Bath, UK.'}, {'ForeName': 'Fareeda', 'Initials': 'F', 'LastName': 'Coxon', 'Affiliation': 'The Northern Oesophago-Gastric Cancer Unit, Royal Victoria Infirmary, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Birmingham Heartlands Hospital, Birmingham, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'Bristol and University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Robb', 'Affiliation': ""St George's, University of London, London, UK.""}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Stenning', 'Affiliation': 'Medical Research Council Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Langley', 'Affiliation': 'Medical Research Council Clinical Trials Unit at UCL, London, UK.'}]",The Lancet. Oncology,['10.1016/S1470-2045(17)30447-3']
1507,32412314,Randomized trial of electrodynamic microneedling combined with 5% minoxidil topical solution for treating androgenetic alopecia in Chinese males and molecular mechanistic study of the involvement of the Wnt/β-catenin signaling pathway.,"Background:  Treatment of androgenetic alopecia (AGA) with concurrent electrodynamic microneedling and 5% minoxidil may further stimulate hair growth. Objectives:  To evaluate the efficacy of microneedling combined with 5% minoxidil in Chinese male AGA patients and to explore the underlying mechanisms. Methods:  Seventy-one male volunteers with AGA completed the entire trial and follow-up. The first group (n = 23) received only 5% minoxidil twice daily for 24 weeks; the second group (n = 23) received only microneedle therapy every 3 weeks for 8 treatments; and the third group (n = 25) received the combination treatment for a total of 24 weeks. Changes in hair density and diameter were evaluated before and after treatment every 3 weeks, and patients were followed up at 6 months after the final treatment. In the combination group, a PCR array was used to detect the expression of molecules in the Wnt/β-catenin pathway within the hair loss sites on top of the head before and after treatment and within the scalp tissues from non-hair loss sites on top of the head. The tissues were obtained by punches in the most severe area of hair loss on top of the head and in the adjacent normal hair area without hair loss. Real-time quantitative PCR and western blotting were used to further examine changes in the differentially expressed molecules identified by PCR array (FZD3) and in molecules in the Wnt/β-catenin signaling pathway closely related to hair growth (β-catenin and LEF-1). Results:  Compared to single minoxidil or single microneedle treatment, the combination therapy showed superior therapeutic effects clinically, with further upregulation of FZD3, β-catenin, and LEF-1 expression levels at both mRNA and protein levels in the treated areas. Conclusions:  Microneedling combined with 5% minoxidil can improve AGA, and the underlying mechanism may involve activation of the Wnt/β-catenin signaling pathway.",2020,"Compared to single minoxidil or single microneedle treatment, the combination therapy showed superior therapeutic effects clinically, with further upregulation of FZD3, β-catenin, and LEF-1 expression levels at both mRNA and protein levels in the treated areas.","['Chinese male AGA patients', 'Methods:  Seventy-one male volunteers with AGA completed the entire trial and follow-up', 'androgenetic alopecia (AGA', 'Chinese males']","['concurrent electrodynamic microneedling and 5% minoxidil', 'minoxidil', 'microneedling combined with 5% minoxidil', 'electrodynamic microneedling combined with 5% minoxidil topical solution']","['FZD3, β-catenin, and LEF-1 expression levels', 'hair density and diameter']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0071561', 'cui_str': 'polyethylene glycol-glutaminase-asparaginase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0307514', 'cui_str': 'Minoxidil Topical Solution [Rogaine]'}]","[{'cui': 'C1175384', 'cui_str': 'FZD3 protein, human'}, {'cui': 'C1564904', 'cui_str': 'Catenin Proteins'}, {'cui': 'C1506866', 'cui_str': 'LEF1 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]",71.0,0.023775,"Compared to single minoxidil or single microneedle treatment, the combination therapy showed superior therapeutic effects clinically, with further upregulation of FZD3, β-catenin, and LEF-1 expression levels at both mRNA and protein levels in the treated areas.","[{'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Bao', 'Affiliation': ""Department of Dermatology, Shenzhen People's Hospital, 2nd Clinical Medical College of Jinan University, Shenzhen, China.""}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Zong', 'Affiliation': 'Department of NICU, Shenzhen Maternity and Child Healthcare Hospital, Shenzhen, China.'}, {'ForeName': 'Sining', 'Initials': 'S', 'LastName': 'Fang', 'Affiliation': ""Department of Dermatology, Shenzhen People's Hospital, 2nd Clinical Medical College of Jinan University, Shenzhen, China.""}, {'ForeName': 'Lixiong', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': ""Department of Dermatology, Shenzhen People's Hospital, 2nd Clinical Medical College of Jinan University, Shenzhen, China.""}, {'ForeName': 'Yuanhong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, The First Affiliated Hospital of China Medical University, Shenyang, China.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1770162']
1508,28729154,"Tremelimumab as second-line or third-line treatment in relapsed malignant mesothelioma (DETERMINE): a multicentre, international, randomised, double-blind, placebo-controlled phase 2b trial.","BACKGROUND


New therapeutic strategies for malignant mesothelioma are urgently needed. In the DETERMINE study, we investigated the effects of the cytotoxic-T-lymphocyte-associated antigen 4 (CTLA-4) monoclonal antibody tremelimumab in patients with previously treated advanced malignant mesothelioma.
METHODS


DETERMINE was a double-blind, placebo-controlled, phase 2b trial done at 105 study centres across 19 countries in patients with unresectable pleural or peritoneal malignant mesothelioma who had progressed after one or two previous systemic treatments for advanced disease. Eligible patients were aged 18 years or older with Eastern Cooperative Oncology Group performance status of 0 or 1 and measurable disease as defined in the modified Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 for pleural mesothelioma or RECIST version 1.1 for peritoneal mesothelioma. Patients were randomly assigned (2:1) in blocks of three, stratified by European Organisation for Research and Treatment of Cancer status (low risk vs high risk), line of therapy (second line vs third line), and anatomic site (pleural vs peritoneal), by use of an interactive voice or web system, to receive intravenous tremelimumab (10 mg/kg) or placebo every 4 weeks for 7 doses and every 12 weeks thereafter until a treatment discontinuation criterion was met. The primary endpoint was overall survival in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of study drug. The trial is ongoing but no longer recruiting participants, and is registered with ClinicalTrials.gov, number NCT01843374.
FINDINGS


Between May 17, 2013, and Dec 4, 2014, 571 patients were randomly assigned to receive tremelimumab (n=382) or placebo (n=189), of whom 569 patients received treatment (two patients in the tremelimumab group were excluded from the safety population because they did not receive treatment). At the data cutoff date (Jan 24, 2016), 307 (80%) of 382 patients had died in the tremelimumab group and 154 (81%) of 189 patients had died in the placebo group. Median overall survival in the intention-to-treat population did not differ between the treatment groups: 7·7 months (95% CI 6·8-8·9) in the tremelimumab group and 7·3 months (5·9-8·7) in the placebo group (hazard ratio 0·92 [95% CI 0·76-1·12], p=0·41). Treatment-emergent adverse events of grade 3 or worse occurred in 246 (65%) of 380 patients in the tremelimumab group and 91 (48%) of 189 patients in the placebo group; the most common were dyspnoea (34 [9%] patients in the tremelimumab group vs 27 [14%] patients in the placebo group), diarrhoea (58 [15%] vs one [<1%]), and colitis (26 [7%] vs none). The most common serious adverse events were diarrhoea (69 [18%] patients in the tremelimumab group vs one [<1%] patient in the placebo group), dyspnoea (29 [8%] vs 24 [13%]), and colitis (24 [6%] vs none). Treatment-emergent events leading to death occurred in 36 (9%) of 380 patients in the tremelimumab group and 12 (6%) of 189 in the placebo group; those leading to the death of more than one patient were mesothelioma (three [1%] patients in the tremelimumab group vs two [1%] in the placebo group), dyspnoea (three [1%] vs two [1%]); respiratory failure (one [<1%] vs three [2%]), myocardial infarction (three [1%] vs none), lung infection (three [1%] patients vs none), cardiac failure (one [<1%] vs one [<1%]), and colitis (two [<1%] vs none). Treatment-related adverse events leading to death occurred in five (1%) patients in the tremelimumab group and none in the placebo group. The causes of death were lung infection in one patient, intestinal perforation and small intestinal obstruction in one patient; colitis in two patients, and neuritis and skin ulcer in one patient.
INTERPRETATION


Tremelimumab did not significantly prolong overall survival compared with placebo in patients with previously treated malignant mesothelioma. The safety profile of tremelimumab was consistent with the known safety profile of CTLA-4 inhibitors. Investigations into whether immunotherapy combination regimens can provide greater efficacy than monotherapies in malignant mesothelioma are ongoing.
FUNDING


AstraZeneca.",2017,"Median overall survival in the intention-to-treat population did not differ between the treatment groups: 7·7 months (95% CI 6·8-8·9) in the tremelimumab group and 7·3 months (5·9-8·7) in the placebo group (hazard ratio 0·92 [95% CI 0·76-1·12], p=0·41).","['patients with previously treated advanced malignant mesothelioma', '105 study centres across 19 countries in patients with unresectable pleural or peritoneal malignant mesothelioma who had progressed after one or two previous systemic treatments for advanced disease', 'Eligible patients were aged 18 years or older with Eastern Cooperative Oncology Group performance status of 0 or 1 and measurable disease as defined in the modified Response Evaluation Criteria', 'Between May 17, 2013, and Dec 4, 2014, 571 patients', 'patients with previously treated malignant mesothelioma']","['European Organisation for Research and Treatment of Cancer status (low risk vs high risk), line of therapy (second line vs third line), and anatomic site (pleural vs peritoneal), by use of an interactive voice or web system, to receive intravenous tremelimumab', 'cytotoxic-T-lymphocyte-associated antigen 4 (CTLA-4) monoclonal antibody tremelimumab', 'placebo', 'Tremelimumab', 'tremelimumab']","['respiratory failure', 'colitis', 'death', 'lung infection', 'diarrhoea', 'dyspnoea ', 'myocardial infarction', 'cardiac failure', 'intestinal perforation and small intestinal obstruction', 'dyspnoea', 'Median overall survival', 'overall survival', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0345967', 'cui_str': 'Mesothelioma, malignant (morphologic abnormality)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C1522720', 'cui_str': 'Pleural (qualifier value)'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0035168'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1522720', 'cui_str': 'Pleural (qualifier value)'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0039195', 'cui_str': 'Cell-Mediated Lympholytic Cells'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3889105', 'cui_str': 'Respiratory failure (SMQ)'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0876973', 'cui_str': 'Pulmonary infection'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0021845', 'cui_str': 'Intestinal Perforation'}, {'cui': 'C0235329', 'cui_str': 'Small bowel obstruction (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",571.0,0.65839,"Median overall survival in the intention-to-treat population did not differ between the treatment groups: 7·7 months (95% CI 6·8-8·9) in the tremelimumab group and 7·3 months (5·9-8·7) in the placebo group (hazard ratio 0·92 [95% CI 0·76-1·12], p=0·41).","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Maio', 'Affiliation': 'Medical Oncology and Immunotherapy, Center for Immuno-Oncology, University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy. Electronic address: mmaiocro@gmail.com.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Scherpereel', 'Affiliation': 'Pulmonary and Thoracic Oncology, University of Lille, CHU de Lille, Lille, France.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Calabrò', 'Affiliation': 'Medical Oncology and Immunotherapy, Center for Immuno-Oncology, University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Aerts', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Susana Cedres', 'Initials': 'SC', 'LastName': 'Perez', 'Affiliation': ""Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Bearz', 'Affiliation': 'Centro di Riferimento Oncologico di Aviano, Pordenone, Italy.'}, {'ForeName': 'Kristiaan', 'Initials': 'K', 'LastName': 'Nackaerts', 'Affiliation': 'KU Leuven-University of Leuven, University Hospitals, Leuven, Belgium.'}, {'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Fennell', 'Affiliation': 'University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Kowalski', 'Affiliation': 'Maria Sklodowska-Curie Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Anne S', 'Initials': 'AS', 'LastName': 'Tsao', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Taylor', 'Affiliation': 'University Hospital of South Manchester, Manchester, UK.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Grosso', 'Affiliation': 'Mesothelioma Unit-Medical Oncology Department, SS Antonio e Biagio General Hospital, Alessandria, Italy.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Antonia', 'Affiliation': 'H Lee Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Nowak', 'Affiliation': 'School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia; Department of Medical Oncology, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Taboada', 'Affiliation': 'AstraZeneca, Alderley Park, Macclesfield, UK.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Puglisi', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Stockman', 'Affiliation': 'AstraZeneca, Alderley Park, Macclesfield, UK.'}, {'ForeName': 'Hedy L', 'Initials': 'HL', 'LastName': 'Kindler', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(17)30446-1']
1509,32412358,A Randomized Placebo Controlled Clinical Trial Demonstrating Safety & Efficacy of EnXtra ®  in Healthy Adults.,"Objective:  The present randomized, placebo-controlled study aimed to assess the long-term safety and perceivable mental acuity benefits of EnXtra ®  in healthy individuals. Methods:  Study participants were administered EnXtra ®  with or without caffeine for a period of 12 weeks. The cardiovascular safety was evaluated by assessing change in QT interval, blood pressure and heart rate. Further, other efficacy variables evaluated were change in perceived alertness and calmness by Bond and Lader mood scales, Sleep disturbance by Pittsburgh sleep quality Index and daytime sleepiness by Epworth sleepiness scale. Results:  None of the study group showed any significant change in the ECG or haemodynamic parameters as compared to baseline (p > 0.05). Post consumption, alertness and calmness scores were significantly increased in the EnXtra ® , and EnXtra ®  plus caffeine group (p < 0.001) as compared to placebo. Daytime sleep scores decreased in the EnXtra ®  group however change was not significant. Sleep quality remained undisturbed in all three arms. Conclusion:  The findings demonstrated the psychostimulant efficacy of EnXtra ®  with no safety concerns on long-term usage.",2020,"Post consumption, alertness and calmness scores were significantly increased in the EnXtra ® , and EnXtra ®  plus caffeine group (p < 0.001) as compared to placebo.","['Healthy Adults', 'healthy individuals']","['EnXtra ®', 'Placebo', 'EnXtra ®  with or without caffeine', 'placebo']","['perceived alertness and calmness by Bond and Lader mood scales, Sleep disturbance by Pittsburgh sleep quality Index and daytime sleepiness by Epworth sleepiness scale', 'QT interval, blood pressure and heart rate', 'Sleep quality', 'Daytime sleep scores', 'Post consumption, alertness and calmness scores', 'cardiovascular safety', 'ECG or haemodynamic parameters']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C4075948', 'cui_str': 'Sleeps during day'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.181249,"Post consumption, alertness and calmness scores were significantly increased in the EnXtra ® , and EnXtra ®  plus caffeine group (p < 0.001) as compared to placebo.","[{'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': 'Department of Clinical development, Enovate Biolife, Mumbai, Maharashtra, India.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mennemeier', 'Affiliation': 'Neurobiology and Developmental Sciences, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.'}, {'ForeName': 'Jayesh Anand', 'Initials': 'JA', 'LastName': 'Chaudhary', 'Affiliation': 'Vedic Lifesciences, Mumbai, Maharashtra, India.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2020.1753129']
1510,32412597,"Snacking on whole almonds for 6 weeks improves endothelial function and lowers LDL cholesterol but does not affect liver fat and other cardiometabolic risk factors in healthy adults: the ATTIS study, a randomized controlled trial.","BACKGROUND


There is convincing evidence that daily whole almond consumption lowers blood LDL cholesterol concentrations, but effects on other cardiometabolic risk factors such as endothelial function and liver fat are still to be determined.
OBJECTIVES


We aimed to investigate whether isoenergetic substitution of whole almonds for control snacks with the macronutrient profile of average snack intakes, had any impact on markers of cardiometabolic health in adults aged 30-70 y at above-average risk of cardiovascular disease (CVD).
METHODS


The study was a 6-wk randomized controlled, parallel-arm trial. Following a 2-wk run-in period consuming control snacks (mini-muffins), participants consumed either whole roasted almonds (n = 51) or control snacks (n = 56), providing 20% of daily estimated energy requirements. Endothelial function (flow-mediated dilation), liver fat (MRI/magnetic resonance spectroscopy), and secondary outcomes as markers of cardiometabolic disease risk were assessed at baseline and end point.
RESULTS


Almonds, compared with control, increased endothelium-dependent vasodilation (mean difference 4.1%-units of measurement; 95% CI: 2.2, 5.9), but there were no differences in liver fat between groups. Plasma LDL cholesterol concentrations decreased in the almond group relative to control (mean difference -0.25 mmol/L; 95% CI: -0.45, -0.04), but there were no group differences in triglycerides, HDL cholesterol, glucose, insulin, insulin resistance, leptin, adiponectin, resistin, liver function enzymes, fetuin-A, body composition, pancreatic fat, intramyocellular lipids, fecal SCFAs, blood pressure, or 24-h heart rate variability. However, the long-phase heart rate variability parameter, very-low-frequency power, was increased during nighttime following the almond treatment compared with control (mean difference 337 ms2; 95% CI: 12, 661), indicating greater parasympathetic regulation.
CONCLUSIONS


Whole almonds consumed as snacks markedly improve endothelial function, in addition to lowering LDL cholesterol, in adults with above-average risk of CVD.This trial was registered at clinicaltrials.gov as NCT02907684.",2020,"Plasma LDL cholesterol concentrations decreased in the almond group relative to control (mean difference -0.25 mmol/L; 95% CI: -0.45, -0.04), but there were no group differences in triglycerides, HDL cholesterol, glucose, insulin, insulin resistance, leptin, adiponectin, resistin, liver function enzymes, fetuin-A, body composition, pancreatic fat, intramyocellular lipids, fecal SCFAs, blood pressure, or 24-h heart rate variability.","['adults aged 30-70 y at above-average risk of cardiovascular disease (CVD', 'healthy adults']","['2-wk run-in period consuming control snacks (mini-muffins), participants consumed either whole roasted almonds (n\xa0=\xa051) or control snacks']","['liver fat', 'endothelial function', 'cardiometabolic health', 'blood LDL cholesterol concentrations', 'liver fat and other cardiometabolic risk factors', 'endothelial function and lowers LDL cholesterol', 'Endothelial function (flow-mediated dilation), liver fat (MRI/magnetic resonance spectroscopy', 'cardiometabolic disease risk', 'triglycerides, HDL cholesterol, glucose, insulin, insulin resistance, leptin, adiponectin, resistin, liver function enzymes, fetuin-A, body composition, pancreatic fat, intramyocellular lipids, fecal SCFAs, blood pressure, or 24-h heart rate variability', 'endothelium-dependent vasodilation', 'Plasma LDL cholesterol concentrations']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0452660', 'cui_str': 'Muffin'}, {'cui': 'C0440286', 'cui_str': 'Almond'}]","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C1281905', 'cui_str': 'At risk of disease'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0963992', 'cui_str': 'Resistin'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0051477', 'cui_str': 'Alpha>2< hS glycoprotein'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C1278149', 'cui_str': 'Plasma LDL cholesterol measurement'}]",,0.564696,"Plasma LDL cholesterol concentrations decreased in the almond group relative to control (mean difference -0.25 mmol/L; 95% CI: -0.45, -0.04), but there were no group differences in triglycerides, HDL cholesterol, glucose, insulin, insulin resistance, leptin, adiponectin, resistin, liver function enzymes, fetuin-A, body composition, pancreatic fat, intramyocellular lipids, fecal SCFAs, blood pressure, or 24-h heart rate variability.","[{'ForeName': 'Vita', 'Initials': 'V', 'LastName': 'Dikariyanto', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Smith', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Francis', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Robertson', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Eslem', 'Initials': 'E', 'LastName': 'Kusaslan', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': ""O'Callaghan-Latham"", 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Palanche', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""D'Annibale"", 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Dimitra', 'Initials': 'D', 'LastName': 'Christodoulou', 'Affiliation': ""Department of Radiology, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Basty', 'Affiliation': 'Research Centre for Optimal Health, School of Life Sciences, University of Westminster, London, UK.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Whitcher', 'Affiliation': 'Research Centre for Optimal Health, School of Life Sciences, University of Westminster, London, UK.'}, {'ForeName': 'Haris', 'Initials': 'H', 'LastName': 'Shuaib', 'Affiliation': ""Medical Physics, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Charles-Edwards', 'Affiliation': ""Medical Physics, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Chowienczyk', 'Affiliation': ""Department of Clinical Pharmacology, School of Cardiovascular Medicine and Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Ellis', 'Affiliation': ""Biopolymers Group, Departments of Biochemistry and Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Sarah E E', 'Initials': 'SEE', 'LastName': 'Berry', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Hall', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa100']
1511,32412629,The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Responsive Parenting Intervention for Firstborns Affects Dietary Intake of Secondborn Infants.,"BACKGROUND


Although previous work has shown that children with older siblings tend to have poorer diet quality, no study has directly compared diets of infant siblings.
OBJECTIVE


The goals of this analysis were to examine birth-order differences in dietary intake between firstborn (FB) and secondborn (SB) siblings, and to determine whether a responsive parenting (RP) intervention modified birth-order effects on diet.
METHODS


The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) study randomly assigned first-time mothers to an RP intervention, which included guidance on feeding, sleep, soothing, and interactive play, or control. INSIGHT mothers who delivered a second child enrolled in an observation-only study of their SB infant (SIBSIGHT). Mothers completed FFQs for both children at ages 6 (n = 97 sibling pairs) and 12 (n = 100) mo. FB compared with SB intake of food groups of interest were compared, and the moderating effect of the RP intervention on birth-order differences was tested using generalized linear mixed models.
RESULTS


Though FBs and SBs had similar diets, more FBs than SBs consumed 100% fruit juice at both 6 (13.8 compared with 3.2%, P = 0.006) and 12 mo (46.0 compared with 32.0%, P = 0.01). SBs consumed fruit more frequently (FB 2.8 compared with SB 3.2 times/d, P = 0.01), and were more likely to consume fried potatoes (FB 38.4 compared with SB 57.6%, P = 0.0009) and processed meats (FB 43.0 compared with SB 58.0%, P = 0.02) than FBs at 12 mo. There were no differences by birth order in intake of sweets, snacks, or sugar-sweetened beverages at 12 mo. At 12 mo, RP-group SBs ate vegetables more times per day (3.2) than control SBs (2.2, P = 0.01). RP-SBs also consumed a greater variety of vegetables (10.2) than control-SBs (7.9, P = 0.01).
CONCLUSIONS


Birth order is not consistently associated with healthy or unhealthy infant dietary intake. However, an RP intervention delivered to first-time mothers may benefit subsequent infants' vegetable intake. This trial was registered at clinicaltrials.gov as NCT01167270.",2020,"SBs consumed fruit more frequently (FB 2.8 compared with SB 3.2 times/d, P = 0.01), and were more likely to consume fried potatoes (FB 38.4 compared with SB 57.6%, P = 0.0009) and processed meats (FB 43.0 compared with SB 58.0%, P = 0.02) than FBs at 12 mo.","['Secondborn Infants', 'INSIGHT mothers who delivered a second child enrolled in an observation-only study of their SB infant (SIBSIGHT', 'children with older siblings', 'The Intervention Nurses Start Infants']","['RP intervention', 'RP intervention, which included guidance on feeding, sleep, soothing, and interactive play, or control', 'Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT']","['birth order in intake of sweets, snacks, or sugar-sweetened beverages']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0337511', 'cui_str': 'Older sibling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0005607', 'cui_str': 'Place in family order'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}]",,0.0545827,"SBs consumed fruit more frequently (FB 2.8 compared with SB 3.2 times/d, P = 0.01), and were more likely to consume fried potatoes (FB 38.4 compared with SB 57.6%, P = 0.0009) and processed meats (FB 43.0 compared with SB 58.0%, P = 0.02) than FBs at 12 mo.","[{'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Hohman', 'Affiliation': 'Center for Childhood Obesity Research, Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Savage', 'Affiliation': 'Center for Childhood Obesity Research, Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Leann L', 'Initials': 'LL', 'LastName': 'Birch', 'Affiliation': 'Department of Foods and Nutrition, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Paul', 'Affiliation': 'Departments of Pediatrics and Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa135']
1512,31729280,"An Experimental Investigation of Victim Blaming in Sexual Assault: The Roles of Victim Sexual Orientation, Coercion Type, and Stereotypes About Bisexual Women.","Bisexual women are more likely to be sexually assaulted and to receive negative reactions to disclosures of sexual assault than heterosexual and lesbian women. However, few studies have examined the extent to which victim sexual orientation and related factors influence perceptions of sexual assault victims and perpetrators. To fill this gap, the current study used an experimental manipulation to examine the influence of victim sexual orientation and coercion type on perceptions of sexual assault victims and perpetrators. Participants ( N  = 826) were randomly assigned to read one of nine vignettes in which the sexual orientation of the female victim (bisexual, lesbian, heterosexual) and the type of coercion (verbal, physical, alcohol incapacitation) were varied. Then, participants were asked a series of questions about the victim and the perpetrator. Results indicated that bisexual and heterosexual female victims were both perceived as having wanted to have sex with the perpetrator more and as having ""led the perpetrator on"" more than lesbian victims. In contrast, victim sexual orientation was not associated with explicit ratings of victim or perpetrator responsibility or victim suffering. Bisexual female victims were also perceived as more promiscuous than both lesbian and heterosexual female victims. In turn, perceiving the victim as more promiscuous was associated with perceiving the victim as more responsible, having wanted to have sex with the perpetrator more, having ""led the perpetrator on"" more, and suffering less, and with perceiving the perpetrator as less responsible. In sum, our findings suggest that efforts to reduce sexual violence toward bisexual women should attend to negative attitudes toward bisexual women, especially the perception of bisexual women as promiscuous.",2019,Bisexual women are more likely to be sexually assaulted and to receive negative reactions to disclosures of sexual assault than heterosexual and lesbian women.,"['bisexual and heterosexual female victims', 'Sexual Assault', 'Bisexual women', 'Bisexual female victims', 'Participants ( N  = 826']","['nine vignettes in which the sexual orientation of the female victim (bisexual, lesbian, heterosexual) and the type of coercion (verbal, physical, alcohol incapacitation']",['sexual violence'],"[{'cui': 'C2129310', 'cui_str': 'Bisexual (finding)'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0237236', 'cui_str': 'Sexual assault (event)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0205949', 'cui_str': 'Sexual Orientation'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2129310', 'cui_str': 'Bisexual (finding)'}, {'cui': 'C1533642', 'cui_str': 'Women Who Have Sex With Women'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0009236', 'cui_str': 'Coercion'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C3489576', 'cui_str': 'Sexual Violence'}]",826.0,0.0157665,Bisexual women are more likely to be sexually assaulted and to receive negative reactions to disclosures of sexual assault than heterosexual and lesbian women.,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dyar', 'Affiliation': 'Institute for Sexual and Gender Minority Health and Wellbeing, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Feinstein', 'Affiliation': 'Institute for Sexual and Gender Minority Health and Wellbeing, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'RaeAnn E', 'Initials': 'RE', 'LastName': 'Anderson', 'Affiliation': 'University of North Dakota, Grand Forks, USA.'}]",Journal of interpersonal violence,['10.1177/0886260519888209']
1513,31567041,Effect of cash incentives on tetanus toxoid vaccination among rural Nigerian women: a randomized controlled trial.,"Tetanus toxoid vaccination is freely available for most women in developing countries, yet maternal and neonatal tetanus are still prevalent in 13 countries, 9 of which are in sub-Saharan Africa. We evaluated whether providing cash incentives increases the uptake of tetanus toxoid vaccination among women of childbearing age in rural northern Nigeria. We randomized amounts of cash incentives to women in three groups: 5 Nigerian naira (C5), 300 naira (C300), and 800 naira (C800) (150 naira = 1 U.S. dollar). Overall, of 2,482 women from 80 villages, 1,803 (72.6%) women successfully received the vaccination (419 of 765 [54.8%] women in C5, 643 of 850 [75.7%] women in C300, and 741 of 867 [85.5%] women in C800). Women in C300 and C800 were significantly more likely to receive the vaccine than women in C5. We further found that transportation costs are one of the significant barriers that prevent women from receiving vaccination at clinics, and that cash incentives compensate for transportation costs unless such costs are large.",2020,Women in C300 and C800 were significantly more likely to receive the vaccine than women in C5.,"['women of childbearing age in rural northern Nigeria', 'women in three groups: 5 Nigerian naira (C5), 300 naira (C300), and 800 naira (C800) (150 naira = 1 U.S. dollar', 'rural Nigerian women', '2,482 women from 80 villages, 1,803 (72.6%) women successfully received the vaccination (419 of 765 [54.8%] women in C5, 643 of 850 [75.7%] women in C300, and 741 of 867 [85.5%] women in C800']","['cash incentives', 'vaccine', 'Tetanus toxoid vaccination']","['uptake of tetanus toxoid vaccination', 'tetanus toxoid vaccination']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0028075', 'cui_str': 'Federal Republic of Nigeria'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1556089', 'cui_str': 'Nigerians (ethnic group)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0562019', 'cui_str': 'dollar (qualifier value)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3840657', 'cui_str': '850 (qualifier value)'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0305062', 'cui_str': 'Clostridium tetani toxoid antigen, inactivated'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0305062', 'cui_str': 'Clostridium tetani toxoid antigen, inactivated'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",2482.0,0.0926217,Women in C300 and C800 were significantly more likely to receive the vaccine than women in C5.,"[{'ForeName': 'Ryoko', 'Initials': 'R', 'LastName': 'Sato', 'Affiliation': 'Harvard T.H.Chan School of Public Health, Global Health and Population, Boston, MA, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Fintan', 'Affiliation': 'Adamawa Satate Primary Healthcare Development Agency, Nigeria.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1672493']
1514,32412598,"Highly bioavailable curcumin derivative ameliorates Crohn's disease symptoms: A randomized, double-blind, multicenter study.","BACKGROUND & AIMS


The new curcumin derivative Theracurmin® has a 27-fold higher absorption rate than natural curcumin powder. Theracurmin® is an inhibitor of nuclear factor-κB, which mediates the expression of inflammatory cytokines. The effect of Theracurmin® on inflammatory bowel disease in humans has not been explored; therefore, we investigated the efficacy and safety of Theracurmin® in patients with Crohn's disease.
METHODS


In this randomized, double-blinded study performed at 5 independent medical centers in Japan, Theracurmin® (360 mg/day, n=20) or placebo (n=10) was administered to patients with active mild-to-moderate Crohn's disease for 12 weeks. The agent's efficacy was assessed by evaluating clinical and endoscopic remission, healing of anal lesions, and blood levels of inflammatory markers.
RESULTS


In the Theracurmin® group, a significant reduction in clinical disease activity was observed in week 12 relative to that in week 0 (P=0.005). On intention-to-treat analysis, clinical remission rates were 35%, 40%, and 40% at weeks 4, 8, and 12, respectively, which were significantly higher than those in the placebo group (all 0%; P=0.033, P=0.020, and P=0.020, respectively). Furthermore, reduction in endoscopic Crohn's disease severity (P=0.032) was observed at week 12 in the Theracurmin® group. The endoscopic remission rates were 15% and 0% in the Theracurmin® and placebo groups, respectively. Significant healing of anal lesions (P=0.017) was observed at week 8 in the Theracurmin® group. No serious adverse events were observed in either group throughout the study.
CONCLUSIONS


Theracurmin® shows significant clinical and endoscopic efficacy together with a favorable safety profile in patients with active mild-to-moderate Crohn's disease.",2020,Significant healing of anal lesions (P=0.017) was observed at week 8 in the Theracurmin® group.,"[""patients with Crohn's disease"", ""patients with active mild-to-moderate Crohn's disease"", ""n=10) was administered to patients with active mild-to-moderate Crohn's disease for 12 weeks"", '5 independent medical centers in Japan, Theracurmin® (360 mg/day, n=20) or', ""ameliorates Crohn's disease symptoms""]","['Theracurmin®', 'bioavailable curcumin derivative', 'placebo']","['endoscopic remission rates', 'clinical and endoscopic remission, healing of anal lesions, and blood levels of inflammatory markers', 'clinical remission rates', 'serious adverse events', 'clinical disease activity', ""endoscopic Crohn's disease severity"", 'Significant healing of anal lesions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0935763', 'cui_str': 'Bioavailable'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0740980', 'cui_str': 'Anal lesion'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",,0.38788,Significant healing of anal lesions (P=0.017) was observed at week 8 in the Theracurmin® group.,"[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Sugimoto', 'Affiliation': 'The First Department of Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Ikeya', 'Affiliation': 'Centre for Gastroenterology & IBD Research, Hamamatsu South Hospital, Hamamatsu, Japan.'}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Bamba', 'Affiliation': 'Division of Clinical Nutrition, Shiga University of Medical Science, Otsu, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Andoh', 'Affiliation': 'Division of Gastroenterology, Shiga University of Medical Science, Otsu, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yamasaki', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Mitsuyama', 'Affiliation': 'Inflammatory Bowel Disease Centre, Kurume University School of Medicine, Kurume, Japan.'}, {'ForeName': 'Masanao', 'Initials': 'M', 'LastName': 'Nasuno', 'Affiliation': 'IBD Centre, Sapporo Kosei General Hospital, Sapporo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'IBD Centre, Sapporo Kosei General Hospital, Sapporo, Japan.'}, {'ForeName': 'Ai', 'Initials': 'A', 'LastName': 'Matsuura', 'Affiliation': 'Centre for Gastroenterology & IBD Research, Hamamatsu South Hospital, Hamamatsu, Japan.'}, {'ForeName': 'Masaichi', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Centre for Gastroenterology & IBD Research, Hamamatsu South Hospital, Hamamatsu, Japan.'}, {'ForeName': 'Natsuki', 'Initials': 'N', 'LastName': 'Ishida', 'Affiliation': 'The First Department of Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Tamura', 'Affiliation': 'The First Department of Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Takano', 'Affiliation': 'The First Department of Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Tani', 'Affiliation': 'Department of Endoscopic and Photodynamic Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Osawa', 'Affiliation': 'Department of Endoscopic and Photodynamic Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Nishihira', 'Affiliation': 'Department of Medical Management and Informatics, Hokkaido Information University, Ebetsu, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Hanai', 'Affiliation': 'Centre for Gastroenterology & IBD Research, Hamamatsu South Hospital, Hamamatsu, Japan.'}]",Journal of Crohn's & colitis,['10.1093/ecco-jcc/jjaa097']
1515,31591045,"Effect of acupressure at Sanyinjiao on albuminuria in patients with early diabetic nephropathy: A single-blind, randomized, controlled preliminary study.","BACKGROUND


Elevated urinary albumin excretion is a clinical manifestation of early-stage diabetic nephropathy (DN).
PURPOSE


To investigate effect of acupressure at Sanyinjiao on albuminuria in patients with early DN.
METHODS


Total included 53 patients with DN and albuminuria; 21 were assigned to the sham group without acupressure, and 32 were assigned to the experimental group with acupressure at Sanyinjiao (SP6) for 8weeks. The experimental group was divided into experiment A (acupressure <45 days) and experiment B (acupressure ≥45 days). The primary outcome measure was the urine albuminuria/creatinine ratio (UACR) or logarithmic transformed urine microalbumin creatinine ratio (log-UACR) changes, and the secondary outcome measures were the estimated glomerular filtration rate and hemoglobin A1c.
RESULTS


The difference in UACR and log-UACR before and after the study was higher in the experiment B group than in the experiment A and sham groups.
CONCLUSION


Acupressure at Sanyinjiao for 8 weeks may reduce albuminuria in patients with DN. However, this study was a preliminary design.",2020,"The difference in UACR and log-UACR before and after the study was higher in the experiment B group than in the experiment A and sham groups.
","['patients with early DN', 'Total included 53 patients with DN and albuminuria', 'patients with DN', 'patients with early diabetic nephropathy']","['acupressure at Sanyinjiao', 'sham group without acupressure', 'acupressure', 'acupressure at Sanyinjiao (SP6']","['urine albuminuria/creatinine ratio (UACR) or logarithmic transformed urine microalbumin creatinine ratio (log-UACR) changes', 'glomerular filtration rate and hemoglobin A1c', 'UACR and log-UACR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0450548', 'cui_str': 'SP6 (body structure)'}]","[{'cui': 'C0042037'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0740086', 'cui_str': 'Microalbuminuria measurement'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}]",53.0,0.0926829,"The difference in UACR and log-UACR before and after the study was higher in the experiment B group than in the experiment A and sham groups.
","[{'ForeName': 'Shih-Ming', 'Initials': 'SM', 'LastName': 'Chuang', 'Affiliation': 'Graduate Institute of Integrated Medicine, College of Chinese Medicine, China Medical University, Taichung 40402, Taiwan; Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital, Taipei 10449, Taiwan; Mackay Junior College of Medicine, Nursing, and Management, Taipei 11272, Taiwan.'}, {'ForeName': 'Chun-Chuan', 'Initials': 'CC', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital, Taipei 10449, Taiwan.'}, {'ForeName': 'Wan-Yu', 'Initials': 'WY', 'LastName': 'Lo', 'Affiliation': 'Department of Biotechnoloty, Hung Kuang University, Taichung 43302, Taiwan.'}, {'ForeName': 'Ching-Liang', 'Initials': 'CL', 'LastName': 'Hsieh', 'Affiliation': 'Graduate Institute of Integrated Medicine, College of Chinese Medicine, China Medical University, Taichung 40402, Taiwan; Chinese Medicine Research Center, China Medical University, Taichung 40402, Taiwan; Research Center for Chinese Medicine and Acupuncture, China Medical University, Taichung 40402, Taiwan; Department of Chinese Medicine, China Medical University Hospital, Taichung 40402, Taiwan. Electronic address: clhsieh@mail.cmuh.org.tw.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2019.09.001']
1516,28549161,Cigarette Smoking Cessation Intervention for Buprenorphine Treatment Patients.,"Introduction


Patients receiving medication assisted therapy (MAT) for opioid use disorder have high cigarette smoking rates. Cigarette smoking interventions have had limited success. We evaluated an intervention to increase cigarette abstinence rates in patients receiving buprenorphine-assisted therapy.
Methods


Cigarette smokers (N = 175; 78% male; 69% Caucasian; 20% Hispanic), recruited from a buprenorphine clinic were randomly assigned to either an extended innovative system intervention (E-ISI) or to Standard Treatment Control (STC). The E-ISI combined motivational intervention with extended treatment (long-term nicotine replacement therapy , varenicline, and extended cognitive behavioral therapy). STC received written information about quit-lines, medication, and resources. Assessments were held at baseline and 3, 6, 12, and 18 months. Seven-day biochemically verified point-prevalence cigarette abstinence was the primary outcome measure.
Results


Fifty-four percent of E-ISI participants entered the extended treatment intervention; E-ISI and STC differed at 3 months on abstinence status but not at months 6, 12, and 18. E-ISI participants were more likely to attempt to quit, to have a goal of complete abstinence, and to be in a more advanced stage of change than STC participants. A higher number of cigarettes smoked and the use of cannabis in the previous 30 days predicted continued smoking.
Conclusions


The E-ISI was successful in increasing motivation to quit smoking but did not result in long-term abstinence. The failure of treatments that have been efficacious in the general population to produce abstinence in patients receiving MAT of opioid use disorder suggests that harm reduction and other innovative interventions should be explored.
Implications


This study demonstrates that an intervention combining motivational interviewing with an extended treatment protocol can increase cigarette quit attempts, enhance cigarette abstinence goals, and further movement through stages of change about quitting smoking in patients receiving MAT for opioid use disorder who smoke cigarettes. The intervention did not increase abstinence rates over those observed in a standard treatment control, however. The latter finding supports those of earlier investigators who also failed to find efficacy for smoking cessation in this population and who also used interventions effective in the general population. This pattern of findings suggests that patients with opioid use disorder can be motivated to change smoking behavior, but alternative and innovative approaches to cigarette smoking treatment should be studied.",2018,"The failure of treatments that have been efficacious in the general population to produce abstinence in patients receiving MAT of opioid use disorder suggests that harm reduction and other innovative interventions should be explored.
","['Treatment Patients', 'Methods\n\n\nCigarette smokers (N = 175; 78% male; 69% Caucasian; 20% Hispanic), recruited from a buprenorphine clinic', 'patients receiving buprenorphine-assisted therapy', 'patients with opioid use disorder', 'patients receiving MAT for opioid use disorder who smoke cigarettes']","['Cigarette smoking interventions', 'Cigarette Smoking Cessation Intervention', 'Buprenorphine', 'motivational intervention with extended treatment (long-term nicotine replacement therapy , varenicline, and extended cognitive behavioral therapy', 'extended innovative system intervention (E-ISI) or to Standard Treatment Control (STC', 'medication assisted therapy (MAT']","['abstinence rates', 'cigarette quit attempts, enhance cigarette abstinence goals', 'cigarette abstinence rates', 'motivation to quit smoking']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0066317', 'cui_str': 'trisulfide methyl 2-propenyl'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0066317', 'cui_str': 'trisulfide methyl 2-propenyl'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]",,0.0230266,"The failure of treatments that have been efficacious in the general population to produce abstinence in patients receiving MAT of opioid use disorder suggests that harm reduction and other innovative interventions should be explored.
","[{'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Hall', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Humfleet', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Gasper', 'Affiliation': 'California Department of Health Care Services, Sacramento, CA.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Delucchi', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Hersh', 'Affiliation': 'Desert AIDS Project, Palm Springs, CA.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Guydish', 'Affiliation': 'Philip R. Lee institute for Health Policy studies, University of California, San Francisco, CA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntx113']
1517,28734759,"Nivolumab in patients with metastatic DNA mismatch repair-deficient or microsatellite instability-high colorectal cancer (CheckMate 142): an open-label, multicentre, phase 2 study.","BACKGROUND


Metastatic DNA mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) colorectal cancer has a poor prognosis after treatment with conventional chemotherapy and exhibits high levels of tumour neoantigens, tumour-infiltrating lymphocytes, and checkpoint regulators. All of these features are associated with the response to PD-1 blockade in other tumour types. Therefore, we aimed to study nivolumab, a PD-1 immune checkpoint inhibitor, in patients with dMMR/MSI-H metastatic colorectal cancer.
METHODS


In this ongoing, multicentre, open-label, phase 2 trial, we enrolled adults (aged ≥18 years) with histologically confirmed recurrent or metastatic colorectal cancer locally assessed as dMMR/MSI-H from 31 sites (academic centres and hospitals) in eight countries (Australia, Belgium, Canada, France, Ireland, Italy, Spain, and the USA). Eligible patients had progressed on or after, or been intolerant of, at least one previous line of treatment, including a fluoropyrimidine and oxaliplatin or irinotecan. Patients were given 3 mg/kg nivolumab every 2 weeks until disease progression, death, unacceptable toxic effects, or withdrawal from study. The primary endpoint was investigator-assessed objective response as per Response Evaluation Criteria in Solid Tumors (version 1.1). All patients who received at least one dose of study drug were included in all analyses. This trial is registered with ClinicalTrials.gov, number NCT02060188.
FINDINGS


Of the 74 patients who were enrolled between March 12, 2014, and March 16, 2016, 40 (54%) had received three or more previous treatments. At a median follow-up of 12·0 months (IQR 8·6-18·0), 23 (31·1%, 95% CI 20·8-42·9) of 74 patients achieved an investigator-assessed objective response and 51 (69%, 57-79) patients had disease control for 12 weeks or longer. Median duration of response was not yet reached; all responders were alive, and eight had responses lasting 12 months or longer (Kaplan-Meier 12-month estimate 86%, 95% CI 62-95). The most common grade 3 or 4 drug-related adverse events were increased concentrations of lipase (six [8%]) and amylase (two [3%]). 23 (31%) patients died during the study; none of these deaths were deemed to be treatment related by the investigator.
INTERPRETATION


Nivolumab provided durable responses and disease control in pre-treated patients with dMMR/MSI-H metastatic colorectal cancer, and could be a new treatment option for these patients.
FUNDING


Bristol-Myers Squibb.",2017,"Median duration of response was not yet reached; all responders were alive, and eight had responses lasting 12 months or longer (Kaplan-Meier 12-month estimate 86%, 95% CI 62-95).","['enrolled adults (aged ≥18 years) with histologically confirmed recurrent or metastatic colorectal cancer locally assessed as dMMR/MSI-H from 31 sites (academic centres and hospitals) in eight countries (Australia, Belgium, Canada, France, Ireland, Italy, Spain, and the USA', 'All patients who received at least one dose of study drug were included in all analyses', '74 patients who were enrolled between March 12, 2014, and March 16, 2016, 40 (54%) had received three or more previous treatments', 'pre-treated patients with dMMR/MSI-H metastatic colorectal cancer', 'patients with metastatic DNA mismatch repair-deficient or microsatellite instability-high colorectal cancer (CheckMate 142', 'patients with dMMR/MSI-H metastatic colorectal cancer', 'Eligible patients had progressed on or after, or been intolerant of, at least one previous line of treatment, including a']","['fluoropyrimidine and oxaliplatin or irinotecan', 'conventional chemotherapy', 'Nivolumab']","['investigator-assessed objective response as per Response Evaluation Criteria in Solid Tumors', 'Median duration of response']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0022067', 'cui_str': 'Ireland, Republic of'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1155661', 'cui_str': 'Mismatch Repair'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C4544822', 'cui_str': 'MSI-H colorectal cancer'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}]","[{'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",,0.337809,"Median duration of response was not yet reached; all responders were alive, and eight had responses lasting 12 months or longer (Kaplan-Meier 12-month estimate 86%, 95% CI 62-95).","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Overman', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: moverman@mdanderson.org.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'McDermott', 'Affiliation': ""St Vincent's University Hospital and Cancer Trials Ireland, Dublin, Ireland.""}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Leach', 'Affiliation': 'Allina Health System, Minneapolis, MN, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Istituto Oncologico Veneto IOV-IRCSS, Padova, Italy.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'USC Norris Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Morse', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Jayesh', 'Initials': 'J', 'LastName': 'Desai', 'Affiliation': 'Royal Melbourne Hospital/Peter MacCallum Cancer Centre, Victoria, VIC, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'Tasman Oncology Research Ltd, Southport, Queensland, QLD, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Axelson', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Moss', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Monica V', 'Initials': 'MV', 'LastName': 'Goldberg', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Z Alexander', 'Initials': 'ZA', 'LastName': 'Cao', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Ledeine', 'Affiliation': ""Bristol-Myers Squibb, Braine-L'Alleud, Belgium.""}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Maglinte', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Kopetz', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'André', 'Affiliation': 'Hôpital Saint Antoine, Assistance Publique Hôpitaux de Paris and Sorbonne Universités, UMPC Paris 06, Paris, France.'}]",The Lancet. Oncology,['10.1016/S1470-2045(17)30422-9']
1518,31813307,Elastic pneumatic tourniquet cuff versus conventional polyurethane elastomer cuff for hand surgery: a randomized study.,,2020,,['hand surgery'],['Elastic pneumatic tourniquet cuff versus conventional polyurethane elastomer cuff'],[],"[{'cui': 'C0187067', 'cui_str': 'Operative procedure on hand'}]","[{'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0180209', 'cui_str': 'Tourniquet cuff'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0032616', 'cui_str': 'Polyisocyanate'}, {'cui': 'C0013766', 'cui_str': 'Elastomer'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}]",[],,0.0263387,,"[{'ForeName': 'Jae-Young', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Orthopedic Surgery, Kyung Hee University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Min Bom', 'Initials': 'MB', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hyuk-Soo', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University Hospital, Seoul, Republic of Korea.'}]","The Journal of hand surgery, European volume",['10.1177/1753193419892523']
1519,28471839,Brief Report: Impact of Early Antiretroviral Therapy on the Performance of HIV Rapid Tests and HIV Incidence Assays.,"BACKGROUND


Antiretroviral therapy (ART) can downregulate antibody responses to HIV infection. We evaluated the impact of early vs. delayed ART on the performance of HIV diagnostic and incidence assays.
METHODS


Samples were obtained from 207 participants in the HPTN 052 trial, who were stably suppressed on ART for ≥4 years [Malawi sites; pre-ART CD4 cell count 350-550 cells/mm (early ART arm, N = 180) or <250 cells/mm or an AIDS-defining illness (delayed ART arm, N = 27)]. Samples were tested with 2 HIV rapid tests and 2 HIV incidence assays; selected samples were also tested with two fourth-generation immunoassays and a Western blot (WB) assay. A pre-ART sample was analyzed if the follow-up sample had a false-negative or weakly-reactive rapid test result, or had an incidence assay result indicative of recent infection (false-recent result).
RESULTS


Ten (4.8%) samples had a nonreactive or weakly-reactive rapid test result (7/180 early ART arm, 3/27 delayed ART arm, P = 0.13); one sample had nonreactive fourth-generation assay results and 3 had indeterminate WBs. Forty (18.9%) samples had a false-recent incidence assay result; 16 (7.8%) had false-recent results with both incidence assays. Baseline samples had stronger rapid test and WB bands, higher fourth-generation assay signal-to-cutoff values, and fewer HIV incidence assay results indicative of recent infection.
CONCLUSIONS


False-negative/weakly-reactive HIV rapid tests and false-recent HIV incidence assay results were observed in virally-suppressed individuals, regardless of pre-ART CD4 cell count. Downregulation of the antibody response to HIV infection in the setting of ART may impact population-level surveys of HIV prevalence and incidence.",2017,Forty (18.9%) samples had a false-recent incidence assay result; 16 (7.8%) had false-recent results with both incidence assays.,"['Samples were obtained from 207 participants in the HPTN 052 trial, who were stably suppressed on ART for ≥4 years [Malawi sites; pre-ART CD4 cell count 350-550 cells/mm (early ART arm, N = 180) or <250 cells/mm or an AIDS-defining illness (delayed ART arm, N = 27']","['Early Antiretroviral Therapy', 'Antiretroviral therapy (ART']",['Performance of HIV Rapid Tests and HIV Incidence Assays'],"[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}]",,0.273749,Forty (18.9%) samples had a false-recent incidence assay result; 16 (7.8%) had false-recent results with both incidence assays.,"[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Fogel', 'Affiliation': 'Departments of *Pathology; and †Medicine, Johns Hopkins University, School of Medicine, Baltimore, MD; ‡Laboratory of Immunoregulation, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Baltimore, MD; §Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA; ‖Science Facilitation Department, FHI 360, Washington, DC; ¶Science Facilitation Department, FHI 360, Durham, NC; #UNC Project Laboratory, Tidziwe Centre, Kamuzu Central Hospital, Lilongwe, Malawi; **College of Medicine-Johns Hopkins Project, Blantyre, Malawi; ††Division of Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC; ‡‡UNC Project-Malawi, Institute for Global Health and Infectious Diseases, Lilongwe, Malawi; §§Vaccine and Infectious Disease Division and Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA; and ‖‖Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Piwowar-Manning', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Debevec', 'Affiliation': ''}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Walsky', 'Affiliation': ''}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Schlusser', 'Affiliation': ''}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Laeyendecker', 'Affiliation': ''}, {'ForeName': 'Ethan A', 'Initials': 'EA', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'Marybeth', 'Initials': 'M', 'LastName': 'McCauley', 'Affiliation': ''}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Gamble', 'Affiliation': ''}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Tegha', 'Affiliation': ''}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Soko', 'Affiliation': ''}, {'ForeName': 'Johnstone', 'Initials': 'J', 'LastName': 'Kumwenda', 'Affiliation': ''}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': ''}, {'ForeName': 'Ying Q', 'Initials': 'YQ', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Myron S', 'Initials': 'MS', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Eshleman', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000001421']
1520,31537275,Asymptomatic Patients With Abnormal Fractional Flow Reserve Treated With Medication Alone or With PCI.,,2019,,['Asymptomatic Patients With Abnormal Fractional Flow Reserve Treated With'],['Medication Alone or With PCI'],[],"[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]",[],,0.0115166,,"[{'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Fournier', 'Affiliation': ''}, {'ForeName': 'Yuhei', 'Initials': 'Y', 'LastName': 'Kobayashi', 'Affiliation': ''}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Fearon', 'Affiliation': ''}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Collet', 'Affiliation': ''}, {'ForeName': 'Bruno Roza', 'Initials': 'BR', 'LastName': 'da Costa', 'Affiliation': ''}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Rioufol', 'Affiliation': ''}, {'ForeName': 'Nico H J', 'Initials': 'NHJ', 'LastName': 'Pijls', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'De Bruyne', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.07.068']
1521,32412683,Costs and uptake of a community model of paediatric food allergy care versus specialist hospital care: A before-and-after controlled trial.,"AIM


To compare the costs of community-based food allergy model of care (intervention cohort, IC) with a tertiary-hospital, specialist allergy clinic model of care (control cohort, CC).
METHODS


In this pragmatic controlled trial, children (aged 0-12 years) newly referred to the allergy clinic at Melbourne's Royal Children's Hospital with suspected/known food allergy to three or fewer foods were allocated to see either a community-based paediatrician, trained via online webinars and web-based clinical decision support tools for food allergy diagnosis and management, or a hospital allergist. Per-patient costs to the health-care system and out-of-pocket costs to families seen within 12 months (clinician time, allergy tests and medicare billing) were compared between the two models of care.
RESULTS


At 12 months, 54/181 (30%) CC families had been seen in the allergy clinic and 93/115 (81%) of the IC families who chose to see a community paediatrician had been seen. In an intention-to-treat analysis (ITT), health-care system costs per IC patient were higher than the costs per CC patient (mean cost $333 versus $319, respectively; mean difference $14, 95% Confidence Interval (CI) -97 to 118, P = 0.81). Total out-of-pocket costs to family were $129 in the IC compared with $89 in the CC (mean difference $40, 95% CI $4-$77, P = 0.03).
CONCLUSIONS


A community-based model of care for simple food allergy showed that costs to the health-care system were similar between the community model and hospital care but did not show reduced out-of-pocket costs to the families 12-months post-enrolment.",2020,"In an intention-to-treat analysis (ITT), health-care system costs per IC patient were higher than the costs per CC patient (mean cost $333 versus $319, respectively; mean difference $14, 95% Confidence Interval (CI) -97 to 118, P = 0.81).","[""children (aged 0-12\u2009years) newly referred to the allergy clinic at Melbourne's Royal Children's Hospital with suspected/known food allergy to three or fewer foods"", 'paediatric food allergy care versus specialist hospital care']","['community-based paediatrician, trained via online webinars and web-based clinical decision support tools for food allergy diagnosis and management, or a hospital allergist', 'community-based food allergy model of care (intervention cohort, IC']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C3810819', 'cui_str': 'Allergy clinic'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0016470', 'cui_str': 'Allergy to food'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0237433', 'cui_str': 'Pediatrician'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C4042765', 'cui_str': 'Decision Support, Clinical'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0016470', 'cui_str': 'Allergy to food'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0334896', 'cui_str': 'Clinical immunologist'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]",[],,0.0944563,"In an intention-to-treat analysis (ITT), health-care system costs per IC patient were higher than the costs per CC patient (mean cost $333 versus $319, respectively; mean difference $14, 95% Confidence Interval (CI) -97 to 118, P = 0.81).","[{'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Hiscock', 'Affiliation': ""Health Services Research Unit, Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Prescilla', 'Initials': 'P', 'LastName': 'Perera', 'Affiliation': ""Health Services Research Unit, Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Mimi Lk', 'Initials': 'ML', 'LastName': 'Tang', 'Affiliation': 'Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Danchin', 'Affiliation': 'Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Sung', 'Affiliation': ""Centre for Community Child Health, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Karnon', 'Affiliation': 'School of Public Health, University of Adelaide, Adelaide, South Australia, Australia.'}]",Journal of paediatrics and child health,['10.1111/jpc.14905']
1522,29031771,A nonrandomized controlled clinical pilot trial on 8 wk of intermittent fasting (24 h/wk).,"OBJECTIVE


The aim of the study was to evaluate whether intermittent fasting (IF) is an effective preventive measure, and whether it is feasible for healthy volunteers under every day conditions.
METHODS


A nonrandomized controlled clinical trial on IF was performed with healthy volunteers over a period of 8 wk, and a subsequent 4-mo follow-up. Outcomes were assessed at baseline, after 8 wk, and after 6 mo. Volunteers who were not interested in fasting served as a control group. Participants in the fasting group were asked to continue their regular nutritional habits on the nonfasting days, whereas the control group maintained their habitual nutrition throughout the whole period. Outcomes included changes of metabolic parameters (insulin, glucose, insulin resistance, insulin-like growth factor-1, brain-derived neurotropic factor, lipids, liver enzymes, hemoglobin A1c) and coagulation markers; bioelectrical impedance analysis; body mass index; abdominal girth; blood pressure; general quality of life (five-item World Health Organization Well-Being Index [WHO-5] questionnaire), as well as mood and anxiety (Hospital Anxiety and Depression Scale [HADS], Profile of Mood States, Flourishing-Scale, visual analog scale, Likert scales). The intervention consisted of a fasting day, which was repeated every week for 8 wk, with abstinence from solid food between 00:00 and 23:59 at minimum and a maximum caloric intake of 300 kcal on each fasting day. A per-protocol analysis was performed. P < 0.05 was considered significant.
RESULTS


Thirty-six volunteers were included; 22 allocated themselves to the fasting group, and 14 to the control group. Thirty-three data sets were included in the final analysis. Although significant in-group changes were observed in both groups for a number of outcomes after 8 wk and 6 mo, no significant between-group differences were observed for any outcome other than overall body fat mass after 8 wk as well as for the HADS total score and the WHO-5 total score after 6 mo, all in favor of the fasting group. However, none of the between-group differences were clinically relevant.
CONCLUSIONS


We did not find any clinically relevant differences between groups in this controlled clinical pilot trial of 8 wk of IF in healthy volunteers. Further clinical research in this field is warranted to further analyze mechanisms and effects of IF.",2018,"Although significant in-group changes were observed in both groups for a number of outcomes after 8 wk and 6 mo, no significant between-group differences were observed for any outcome other than overall body fat mass after 8 wk as well as for the HADS total score and the WHO-5 total score after 6 mo, all in favor of the fasting group.","['Volunteers who were not interested in fasting served as a control group', 'healthy volunteers over a period of 8\xa0wk, and a subsequent 4-mo follow-up', 'healthy volunteers', 'Thirty-six volunteers were included; 22 allocated themselves to the fasting group, and 14 to the control group', 'healthy volunteers under every day conditions']",['intermittent fasting (IF'],"['HADS total score and the WHO-5 total score', 'changes of metabolic parameters (insulin, glucose, insulin resistance, insulin-like growth factor-1, brain-derived neurotropic factor, lipids, liver enzymes, hemoglobin A1c) and\xa0coagulation markers; bioelectrical impedance analysis; body mass index; abdominal girth; blood pressure; general quality of life (five-item World Health Organization', 'mood and anxiety (Hospital Anxiety and Depression Scale [HADS', 'Profile of Mood States, Flourishing-Scale, visual analog scale, Likert scales', 'overall body fat mass']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0543488', 'cui_str': 'Interested (finding)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0162536', 'cui_str': 'Bioelectrical Impedance'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",36.0,0.0688988,"Although significant in-group changes were observed in both groups for a number of outcomes after 8 wk and 6 mo, no significant between-group differences were observed for any outcome other than overall body fat mass after 8 wk as well as for the HADS total score and the WHO-5 total score after 6 mo, all in favor of the fasting group.","[{'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Kessler', 'Affiliation': 'Charité- Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, Germany; Immanuel Hospital Berlin, Department of Internal and Complementary Medicine, Berlin, Germany. Electronic address: C.kessler@immanuel.de.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Stange', 'Affiliation': 'Immanuel Hospital Berlin, Department of Internal and Complementary Medicine, Berlin, Germany.'}, {'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'Schlenkermann', 'Affiliation': 'Charité- Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jeitler', 'Affiliation': 'Charité- Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, Germany; Immanuel Hospital Berlin, Department of Internal and Complementary Medicine, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Michalsen', 'Affiliation': 'Charité- Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, Germany; Immanuel Hospital Berlin, Department of Internal and Complementary Medicine, Berlin, Germany.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Selle', 'Affiliation': 'Karl von Ossietzky University Oldenburg, Faculty V for Mathematics and Natural Sciences, Institute for Biology and Environmental Sciences, Oldenburg, Germany.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Raucci', 'Affiliation': 'IFOM FIRC Institute of Molecular Oncology, Milan, Italy.'}, {'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Steckhan', 'Affiliation': 'Charité- Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, Germany.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2017.08.004']
1523,31813281,Baseline Characteristics of the VANISH Cohort.,"BACKGROUND


The VANISH trial (Valsartan for Attenuating Disease Evolution in Early Sarcomeric Hypertrophic Cardiomyopathy) targeted young sarcomeric gene mutation carriers with early-stage hypertrophic cardiomyopathy (HCM) to test whether valsartan can modify disease progression. We describe the baseline characteristics of the VANISH cohort and compare to previous trials evaluating angiotensin receptor blockers.
METHODS


Applying a randomized, double-blinded, placebo-controlled design, 178 participants with nonobstructive HCM (age, 23.3±10.1 years; 61% men) were randomized in the primary cohort and 34 (age, 16.5±4.9 years; 50% men) in the exploratory cohort of sarcomeric mutation carriers without left ventricular hypertrophy.
RESULTS


In the primary cohort, maximal left ventricular wall thickness was 17±4 mm for adults and  Z  score 7.0±4.5 for children. Nineteen percent had late gadolinium enhancement on cardiac magnetic resonance. Mean peak oxygen consumption was 33 mL/kg per minute, and 92% of participants were New York Heart Association functional class I. New York Heart Association class II was associated with older age,  MYH7  variants, and more prominent imaging abnormalities. Six previous trials of angiotensin receptor blockers in HCM enrolled a median of 24 patients (range, 19-133) with mean age of 51.2 years; 42% of patients were in New York Heart Association class ≥II, and sarcomeric mutations were not required.
CONCLUSIONS


The VANISH cohort is much larger, younger, less heterogeneous, and has less advanced disease than prior angiotensin receptor blocker trials in HCM. Participants had relatively normal functional capacity and mild HCM features. New York Heart Association functional class II symptoms were associated with older age, more prominent imaging abnormalities, and  MYH7  variants, suggesting both phenotype and genotype contribute to disease manifestations.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT01912534.",2019,"New York Heart Association functional class II symptoms were associated with older age, more prominent imaging abnormalities, and  MYH7  variants, suggesting both phenotype and genotype contribute to disease manifestations.
","['HCM enrolled a median of 24 patients (range, 19-133) with mean age of 51.2 years; 42% of patients were in New York Heart Association class ≥II, and sarcomeric mutations were not required', '178 participants with nonobstructive HCM (age, 23.3±10.1 years; 61% men) were randomized in the primary cohort and 34 (age, 16.5±4.9 years; 50% men) in the exploratory cohort of sarcomeric mutation carriers without left ventricular hypertrophy']","['placebo', 'valsartan', 'angiotensin receptor blockers', 'VANISH trial (Valsartan']","['maximal left ventricular wall thickness', 'late gadolinium enhancement on cardiac magnetic resonance', 'normal functional capacity and mild HCM features', 'Mean peak oxygen consumption']","[{'cui': 'C0007194', 'cui_str': 'Hypertrophic cardiomyopathy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0340425', 'cui_str': 'Hypertrophic cardiomyopathy without obstruction'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0007194', 'cui_str': 'Hypertrophic cardiomyopathy'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]",178.0,0.398618,"New York Heart Association functional class II symptoms were associated with older age, more prominent imaging abnormalities, and  MYH7  variants, suggesting both phenotype and genotype contribute to disease manifestations.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Axelsson Raja', 'Affiliation': 'Copenhagen University Hospital Rigshospitalet, Denmark (A.A.R., H.B.).'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'New England Research Institutes, Watertown, MA (L.S.).'}, {'ForeName': 'Sharlene M', 'Initials': 'SM', 'LastName': 'Day', 'Affiliation': 'University of Michigan, Ann Arbor (S.M.D., M.R.).'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Russell', 'Affiliation': 'University of Michigan, Ann Arbor (S.M.D., M.R.).'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Zahka', 'Affiliation': 'Cleveland Clinic, OH (K.Z., H.L.).'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Lever', 'Affiliation': 'Cleveland Clinic, OH (K.Z., H.L.).'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Colan', 'Affiliation': ""Boston Children's Hospital, MA (S.D.C., R.M.).""}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Margossian', 'Affiliation': ""Boston Children's Hospital, MA (S.D.C., R.M.).""}, {'ForeName': 'E Kevin', 'Initials': 'EK', 'LastName': 'Hall', 'Affiliation': 'Yale University, New Haven, CT (E.K.H.).'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Becker', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN (J.B.).'}, {'ForeName': 'John Lynn', 'Initials': 'JL', 'LastName': 'Jefferies', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, OH (J.L.J.).""}, {'ForeName': 'Amit R', 'Initials': 'AR', 'LastName': 'Patel', 'Affiliation': 'University of Chicago, IL (A.R.P.).'}, {'ForeName': 'Lubna', 'Initials': 'L', 'LastName': 'Choudhury', 'Affiliation': 'Northwestern University, Chicago, IL (L.C.).'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murphy', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD (A.M.M.).'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Canter', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO (C.C., R.B.).'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bach', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO (C.C., R.B.).'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora (M.T., L.M.).'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Mestroni', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora (M.T., L.M.).'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Wheeler', 'Affiliation': 'Stanford University School of Medicine, Palo Alto, CA (M.T.W.).'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Benson', 'Affiliation': 'Toronto Hospital for Sick Children, ON, Canada (L.B.).'}, {'ForeName': 'Anjali T', 'Initials': 'AT', 'LastName': 'Owens', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, Philadelphia (A.T.O.).'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rossano', 'Affiliation': ""Children's Hospital of Philadelphia, PA (J.R., K.Y.L.).""}, {'ForeName': 'Kimberly Y', 'Initials': 'KY', 'LastName': 'Lin', 'Affiliation': ""Children's Hospital of Philadelphia, PA (J.R., K.Y.L.).""}, {'ForeName': 'Elfriede', 'Initials': 'E', 'LastName': 'Pahl', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, IL (E.P.).""}, {'ForeName': 'Alexandre C', 'Initials': 'AC', 'LastName': 'Pereira', 'Affiliation': 'Heart Institute, University of São Paulo Medical School (Instituto do Coração), Brazil (A.C.P.).'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Bundgaard', 'Affiliation': 'Copenhagen University Hospital Rigshospitalet, Denmark (A.A.R., H.B.).'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Lewis', 'Affiliation': 'Massachusetts General Hospital, Boston (G.D.L.).'}, {'ForeName': 'Jose D', 'Initials': 'JD', 'LastName': 'Vargas', 'Affiliation': 'MedStar Georgetown University Hospital, National Institutes of Health, Bethesda, MD (J.D.V.).'}, {'ForeName': 'Allison L', 'Initials': 'AL', 'LastName': 'Cirino', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA (A.L.C., C.A.M., S.D.S., E.J.O., E.B., C.Y.H.).""}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'University of Glasgow, Glasgow, UK (J.J.V.M.).'}, {'ForeName': 'Calum A', 'Initials': 'CA', 'LastName': 'MacRae', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA (A.L.C., C.A.M., S.D.S., E.J.O., E.B., C.Y.H.).""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA (A.L.C., C.A.M., S.D.S., E.J.O., E.B., C.Y.H.).""}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA (A.L.C., C.A.M., S.D.S., E.J.O., E.B., C.Y.H.).""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA (A.L.C., C.A.M., S.D.S., E.J.O., E.B., C.Y.H.).""}, {'ForeName': 'Carolyn Y', 'Initials': 'CY', 'LastName': 'Ho', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA (A.L.C., C.A.M., S.D.S., E.J.O., E.B., C.Y.H.).""}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.006231']
1524,32412700,"Esketamine Nasal Spray for Rapid Reduction of Major Depressive Disorder Symptoms in Patients Who Have Active Suicidal Ideation With Intent: Double-Blind, Randomized Study (ASPIRE I).","OBJECTIVE


To compare esketamine to placebo, each in addition to standard-of-care treatment, for rapidly reducing major depressive disorder symptoms, including suicidal ideation.
METHODS


This phase 3, double-blind, multicenter study (ASPIRE I), conducted between June 2017 and December 2018, enrolled 226 adults having major depressive disorder based on Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-5) criteria, active suicidal ideation with intent, and need for psychiatric hospitalization. Patients were randomized 1:1 to esketamine 84 mg or placebo nasal spray twice-weekly for 4 weeks, each with comprehensive standard-of-care treatment (initial psychiatric hospitalization and newly initiated or optimized oral antidepressant[s] therapy). Change from baseline to 24 hours post-first dose in Montgomery-Asberg Depression Rating Scale (MADRS) total score (primary endpoint) was analyzed using analysis of covariance (ANCOVA), and change in Clinical Global Impression of Severity of Suicidality Revised version (CGI-SS-r; key secondary endpoint) score was analyzed using ANCOVA on ranks with treatment difference estimated using the Hodges-Lehmann estimate.
RESULTS


Greater improvement in MADRS total score was observed with esketamine + standard-of-care versus placebo + standard-of-care at 24 hours (least-squares mean difference [SE]: -3.8 [1.39]; 95% CI, -6.56 to -1.09; 2-sided P = .006), as well as at earlier (4 hours) and later time points during 4-week double-blind treatment. The difference between groups in the severity of suicidality was not statistically significant (median of treatment difference [95% CI]: 0.0 [-1.00 to 0.00]; 2-sided P = .107). The most common adverse events among esketamine-treated patients were dizziness, dissociation, headache, nausea, and somnolence.
CONCLUSIONS


These findings demonstrate rapid and robust efficacy of esketamine nasal spray in reducing depressive symptoms in severely ill patients with major depressive disorder who have active suicidal ideation with intent.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03039192.",2020,The difference between groups in the severity of suicidality was not statistically significant (median of treatment difference [95% CI]: 0.0 [-1.00 to 0.00]; 2-sided P = .107).,"['severely ill patients with major depressive disorder who have active suicidal ideation with intent', 'June 2017 and December 2018, enrolled 226 adults having major depressive disorder based on Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-5) criteria, active suicidal ideation with intent, and need for psychiatric hospitalization', 'Patients', 'Who Have Active Suicidal Ideation With Intent']","['placebo', 'esketamine nasal spray', 'esketamine 84 mg or placebo nasal spray twice-weekly for 4 weeks, each with comprehensive standard-of-care treatment (initial psychiatric hospitalization and newly initiated or optimized oral antidepressant[s] therapy', 'Esketamine Nasal Spray']","['severity of suicidality', 'Clinical Global Impression of Severity of Suicidality Revised version (CGI-SS-r; key secondary endpoint) score', 'MADRS total score', 'dizziness, dissociation, headache, nausea, and somnolence', 'Major Depressive Disorder Symptoms', 'Montgomery-Asberg Depression Rating Scale (MADRS) total score', 'depressive symptoms']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0749133', 'cui_str': 'Active suicidal ideation'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1096649', 'cui_str': 'Antidepressant therapy'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0086168', 'cui_str': 'Dissociation - mental defense mechanism'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",226.0,0.482575,The difference between groups in the severity of suicidality was not statistically significant (median of treatment difference [95% CI]: 0.0 [-1.00 to 0.00]; 2-sided P = .107).,"[{'ForeName': 'Dong-Jing', 'Initials': 'DJ', 'LastName': 'Fu', 'Affiliation': 'Director, Neuroscience Clinical Development, Janssen Research and Development, LLC, 1125 Trenton-Harbourton Rd, Titusville, NJ 08560. dfu@its.jnj.com.'}, {'ForeName': 'Dawn F', 'Initials': 'DF', 'LastName': 'Ionescu', 'Affiliation': 'Neuroscience Clinical Development, Janssen Research & Development, LLC, San Diego, California, USA.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Quantitative Sciences, Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Rosanne', 'Initials': 'R', 'LastName': 'Lane', 'Affiliation': 'Department of Quantitative Sciences, Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Lim', 'Affiliation': 'Department of Quantitative Sciences, Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hough', 'Affiliation': 'Neuroscience Clinical Development, Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Husseini', 'Initials': 'H', 'LastName': 'Manji', 'Affiliation': 'Neuroscience Clinical Development, Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Wayne C', 'Initials': 'WC', 'LastName': 'Drevets', 'Affiliation': 'Neuroscience Clinical Development, Janssen Research & Development, LLC, San Diego, California, USA.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Canuso', 'Affiliation': 'Neuroscience Clinical Development, Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.19m13191']
1525,32413673,The effects of testosterone on the physiological response to social and somatic stressors.,"Higher testosterone levels in males have previously been linked to decreased stress reactivity, but in other cases, testosterone has been reported to increase the stress response. We addressed these inconsistencies in a placebo-controlled single-dose testosterone administration study, in which 120 male participants were randomly assigned to undergo a cold-pressor test (CPT, a non-social somatic stressor), a socially evaluated cold-pressor test (SECPT, a social-somatic stressor), or a lukewarm water test (LWT, a non-stressful control condition). Throughout the experiment, blood pressure and interbeat intervals were measured continuously, and saliva samples for hormonal analyses were taken repeatedly at predefined time points. When comparing the groups treated with placebo, the SECPT elicited a larger increase in the systolic blood pressure than CPT, in agreement with previous studies. However, testosterone administration altered this pattern. Compared to placebo, testosterone increased systolic blood pressure during the CPT, whereas the opposite effect was found during the SECPT. Cortisol reactivity was not affected by testosterone administration. The CAG repeat polymorphism of the androgen receptor gene was unrelated to the effects of testosterone on the stress response, but it was correlated with blood pressure across the whole sample. Our findings demonstrate that testosterone's effects on the stress response are dependent on the social context. Testosterone's ability to flexibly influence the response to stressors may be an important mechanism through which the hormone promotes adaptive behavior. Our results are also in line with research showing that testosterone decreases social anxiety and suggest it may help to modulate the effects of stress in socially challenging situations.",2020,"When comparing the groups treated with placebo, the SECPT elicited a larger increase in the systolic blood pressure than CPT, in agreement with previous studies.",['120 male participants'],"['SECPT', 'placebo, testosterone', 'testosterone', 'placebo-controlled single-dose testosterone', 'Testosterone', 'cold-pressor test (CPT, a non-social somatic stressor), a socially evaluated cold-pressor test (SECPT, a social-somatic stressor), or a lukewarm water test (LWT, a non-stressful control condition', 'placebo']","['blood pressure', 'blood pressure and interbeat intervals', 'systolic blood pressure', 'social anxiety', 'Cortisol reactivity']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",120.0,0.036,"When comparing the groups treated with placebo, the SECPT elicited a larger increase in the systolic blood pressure than CPT, in agreement with previous studies.","[{'ForeName': 'Hana H', 'Initials': 'HH', 'LastName': 'Kutlikova', 'Affiliation': 'Neuropsychopharmacology and Biopsychology Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria. Electronic address: hana.kutlikova@univie.ac.at.'}, {'ForeName': 'Jaroslava Babková', 'Initials': 'JB', 'LastName': 'Durdiaková', 'Affiliation': 'Institute of Physiology, Faculty of Medicine, Comenius University in Bratislava, Sasinkova 2, 813 72 Bratislava, Slovakia. Electronic address: durdiakova.jaroslava@fmed.uniba.sk.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Wagner', 'Affiliation': 'Institute of Biomedical Science, FH Joanneum University of Applied Sciences, Eggenberger Allee 13, 8020 Graz, Austria. Electronic address: bernhard.wagner@fh-joanneum.at.'}, {'ForeName': 'Miroslav', 'Initials': 'M', 'LastName': 'Vlček', 'Affiliation': 'Institute of Clinical and Translational Research, Biomedical Research Center, Slovak Academy of Sciences, Dúbravská cesta 9, 845 05 Bratislava, Slovakia. Electronic address: miroslav.vlcek@savba.sk.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Eisenegger', 'Affiliation': 'Neuropsychopharmacology and Biopsychology Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Lamm', 'Affiliation': 'Neuropsychopharmacology and Biopsychology Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria; Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria. Electronic address: claus.lamm@univie.ac.at.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Riečanský', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria; Department of Behavioural Neuroscience, Institute of Normal and Pathological Physiology, Centre of Experimental Medicine, Slovak Academy of Sciences, Sienkiewiczova 1, 813 71 Bratislava, Slovakia. Electronic address: igor.riecansky@savba.sk.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104693']
1526,31906054,Academic Effects of the Use of Flipped Learning in Physical Education.,"The technological characteristics of today's society have favored the inclusion of information and communication technology (ICT) and the emergence of new training methodologies in educational spaces. This study addresses flipped learning as an innovative approach in the teaching and learning processes of physical education at two educational stages, primary and secondary education. The objective of this study is to analyze the effectiveness of flipped learning with respect to traditional methodology. A descriptive and correlational experimental research design was used through a quantitative perspective. Two study groups were established, one control (traditional methodology) and one experimental (flipped learning) in each educational stage. A total of 119 students from an educational center in Ceuta (Spain) participated. These participants were chosen intentionally. The data were collected through a questionnaire. The results show that the experimental group obtained better evaluations in the academic indicators, highlighting the motivation, autonomy, and interactions between the different agents. Regarding the effectiveness of flipped learning according to the educational stage, its potential was demonstrated in both stages, highlighting a significant improvement in autonomy in secondary education.",2019,"The results show that the experimental group obtained better evaluations in the academic indicators, highlighting the motivation, autonomy, and interactions between the different agents.",['119 students from an educational center in Ceuta (Spain) participated'],['Flipped Learning'],"['motivation, autonomy, and interactions']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",119.0,0.0196858,"The results show that the experimental group obtained better evaluations in the academic indicators, highlighting the motivation, autonomy, and interactions between the different agents.","[{'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Hinojo Lucena', 'Affiliation': 'Department of Didactics and School Organization, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'López Belmonte', 'Affiliation': 'Department of Didactics and School Organization, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Fuentes Cabrera', 'Affiliation': 'Department of Didactics and School Organization, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Trujillo Torres', 'Affiliation': 'Department of Didactics and School Organization, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Pozo Sánchez', 'Affiliation': 'Department of Didactics and School Organization, University of Granada, 18071 Granada, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17010276']
1527,31582549,"Long-term outcome of a randomized controlled study in patients with newly diagnosed severe aplastic anemia treated with antithymocyte globulin and cyclosporine, with or without granulocyte colony-stimulating factor: a Severe Aplastic Anemia Working Party Trial from the European Group of Blood and Marrow Transplantation.","This follow-up study of a randomized, prospective trial included 192 patients with newly diagnosed severe aplastic anemia receiving antithymoglobulin and cyclosporine, with or without granulocyte colony-stimulating factor (G-CSF). We aimed to evaluate the long-term effect of G-CSF on overall survival, event-free survival, probability of secondary myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), clinical paroxysmal nocturnal hemoglobinuria, relapse, avascular osteonecrosis and chronic kidney disease. The median follow-up was 11.7 years (95% CI, 10.9-12.5). The overall survival rate at 15 years was 57±12% in the group given G-CSF and 63±12% in the group not given G-CSF ( P =0.92); the corresponding event-free survival rates were 24±10% and 23±10%, respectively ( P =0.36). In total, 9 patients developed MDS or AML, 10 only a clonal cytogenetic abnormality, 7 a solid cancer, 18 clinical paroxysmal nocturnal hemoglobinuria, 8 osteonecrosis, and 12 chronic kidney disease, without any difference between patients treated with or without G-CSF. The cumulative incidence of MDS, AML or isolated cytogenetic abnormality at 15 years was 8.5±3% for the G-CSF group and 8.2±3% for the non-G-CSF group ( P =0.90). The cumulative incidence of any late event including myelodysplastic syndrome or acute myeloid leukemia, isolated cytogenetic abnormalities, solid cancer, clinical paroxysmal nocturnal hemoglobinuria, aseptic osteonecrosis, chronic kidney disease and relapse was 50±12% for the G-CSF group and 49±12% for the non-G-CSF group ( P =0.65). Our results demonstrate that it is unlikely that G-CSF has an impact on the outcome of severe aplastic anemia; nevertheless, very late events are common and eventually affect the prognosis of these patients, irrespectively of their age at the time of immunosuppressive therapy (NCT01163942).",2020,"Overall survival at 15 years was 57±12% for the G-CSF and 63±12% for the non-G-CSF group (P=0.92), event-free survival 24±10% for the G-CSF, and 23±10% for the non-G-CSF group (P=0.36).","['192 patients with newly diagnosed severe aplastic anemia receiving Antithymoglobulin and Cyclosporine, with and without G-CSF', 'patients with newly diagnosed severe aplastic anemia treated with']","['G-CSF', 'antithymocyte globuline, cyclosporine, with or without G-CSF']","['Cumulative incidence', 'myelodysplastic syndrome or acute myeloid leukemia', 'Cumulative incidence of any late event including myelodysplastic syndrome or acute myeloid leukemia , isolated cytogenetic abnormalities, solid cancer, clinical paroxysmal nocturnal hemoglobinuria, aseptic osteonecrosis, chronic kidney disease and relapse', 'myelodysplastic syndrome, acute myeloid leukemia or isolated cytogenetic abnormality', 'severe aplastic anemia', 'Overall survival', 'overall survival, event-free survival, probability of secondary myelodysplastic syndrome or acute myeloid leukemia, clinical paroxysmal nocturnal hemoglobinuria, relapse, avascular osteonecrosis and chronic kidney disease']","[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}, {'cui': 'C0003442', 'cui_str': 'Lymphocyte Immune Globulin, Anti-Thymocyte Globulin'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3666007', 'cui_str': 'Myelodysplastic syndrome (SMQ)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0008625', 'cui_str': 'Abnormalities, Chromosome'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0024790', 'cui_str': 'Marchiafava-Micheli Syndrome'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C0029445', 'cui_str': 'Osteonecrosis'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",192.0,0.0456951,"Overall survival at 15 years was 57±12% for the G-CSF and 63±12% for the non-G-CSF group (P=0.92), event-free survival 24±10% for the G-CSF, and 23±10% for the non-G-CSF group (P=0.36).","[{'ForeName': 'André', 'Initials': 'A', 'LastName': 'Tichelli', 'Affiliation': 'Division of Hematology, University Hospital Basel, Basel, Switzerland tichelli@datacomm.ch.'}, {'ForeName': 'Régis Peffault', 'Initials': 'RP', 'LastName': 'de Latour', 'Affiliation': 'Université de Paris, and Hematology-Transplantation, Saint Louis Hospital (AP-HP), Paris, France.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Passweg', 'Affiliation': 'Division of Hematology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Cora', 'Initials': 'C', 'LastName': 'Knol-Bout', 'Affiliation': 'EBMT Registry Office, Leiden, the Netherlands.'}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Socié', 'Affiliation': 'Université de Paris, INSERM U976 and Hematology-Transplantation, Saint Louis Hospital (AP-HP), Paris, France.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Marsh', 'Affiliation': ""Department of Haematological Medicine, King's College Hospital/King's College London, London, UK.""}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Schrezenmeier', 'Affiliation': 'Institute of Tranfusion Medicine, University of Ulm and Institute of Clinical Transfusion Medicine and Immunogenetics Ulm, German Red Cross Blood Transfusion Service Baden-Württemberg-Hessen and University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Höchsmann', 'Affiliation': 'Institute of Tranfusion Medicine, University of Ulm and Institute of Clinical Transfusion Medicine and Immunogenetics Ulm, German Red Cross Blood Transfusion Service Baden-Württemberg-Hessen and University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bacigalupo', 'Affiliation': 'Instituto di Ematologia, Fondazione Policlinico Universitario Gemelli IRCSS, Università Cattolica del Sacro Cuore, Roma, Italy.'}, {'ForeName': 'Sujith', 'Initials': 'S', 'LastName': 'Samarasinghe', 'Affiliation': 'Sujith Samarasinghe, Great Ormond Street Hospital, London, UK.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Rovó', 'Affiliation': 'Department of Hematology and Central Hematology Laboratory, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Kulasekararaj', 'Affiliation': ""Department of Haematological Medicine, King's College Hospital, NIHR/Wellcome King's Clinical Research Facility, London, UK.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Röth', 'Affiliation': 'Department of Hematology, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Dirk-Jan', 'Initials': 'DJ', 'LastName': 'Eikema', 'Affiliation': 'EBMT Registry Office, Leiden, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bosman', 'Affiliation': 'EBMT Registry Office, Leiden, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bader', 'Affiliation': ""University Children's Hospital Frankfurt, Frankfurt, Germany.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Risitano', 'Affiliation': 'Hematology Department of Clinical Medicine and Surgery, Federico II University of Naples, Naples, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Dufour', 'Affiliation': ""Hemato-Onco-SCT Pole, Hematology Unit. G. Gaslini Children's Research Hospital, Genova, Italy.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Haematologica,['10.3324/haematol.2019.222562']
1528,31583921,The effect of soy isoflavone combined with calcium on bone mineral density in perimenopausal Chinese women: a 6-month randomised double-blind placebo-controlled study.,"This study was a prospective, randomised, double-blind, placebo-controlled clinical trial and aimed to compare the effect of placebo, soy isoflavone, calcium and soy isoflavone combined with calcium on bone mineral density (BMD). One hundred and sixty perimenopausal women with osteoporosis or osteopenia were enrolled and randomised into four groups: control, soy isoflavone, calcium and soy isoflavone combined with calcium groups. After intervention, compared with control, isoflavone and calcium groups, mean changes from their corresponding baseline values of BMD, calcium/phosphorus, vitamin D and glutathione peroxidase (GSH-pX) activity were significantly increased, however, those of phosphorus, osteocalcin, luteinizing hormone (LH) and follicle stimulating hormone (FSH) were significantly decreased in isoflavone combined with calcium group. The results showed that soy isoflavone, calcium and isoflavone combined with calcium therapy were effective and safe on attenuating BMD loss in perimenopausal women and isoflavone combined with calcium therapy was better than soy isoflavone and calcium alone.",2020,"After intervention, compared with control, isoflavone and calcium groups, mean changes from their corresponding baseline values of BMD, calcium/phosphorus, vitamin D and glutathione peroxidase (GSH-pX) activity were significantly increased, however, those of phosphorus, osteocalcin, luteinizing hormone (LH) and follicle stimulating hormone (FSH) were significantly decreased in isoflavone combined with calcium group.","['One hundred and sixty perimenopausal women with osteoporosis or osteopenia', 'perimenopausal Chinese women', 'perimenopausal women and']","['soy isoflavone', 'soy isoflavone combined with calcium', 'control, isoflavone and calcium', 'soy isoflavone, calcium and isoflavone combined with calcium therapy', 'placebo', 'placebo, soy isoflavone, calcium and soy isoflavone combined with calcium', 'control, soy isoflavone, calcium and soy isoflavone combined with calcium groups', 'isoflavone', 'isoflavone combined with calcium therapy']","['bone mineral density (BMD', 'phosphorus, osteocalcin, luteinizing hormone (LH) and follicle stimulating hormone (FSH', 'bone mineral density', 'BMD, calcium/phosphorus, vitamin D and glutathione peroxidase (GSH-pX) activity', 'BMD loss']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C4076257', 'cui_str': 'Soy isoflavone (substance)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0023607', 'cui_str': 'Luteinizing Hormone'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0017822', 'cui_str': 'Glutathione:hydrogen-peroxide oxidoreductase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.208177,"After intervention, compared with control, isoflavone and calcium groups, mean changes from their corresponding baseline values of BMD, calcium/phosphorus, vitamin D and glutathione peroxidase (GSH-pX) activity were significantly increased, however, those of phosphorus, osteocalcin, luteinizing hormone (LH) and follicle stimulating hormone (FSH) were significantly decreased in isoflavone combined with calcium group.","[{'ForeName': 'Xinsheng', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Nutrition, Chinese PLA General Hospital, Beijing, PR China.'}, {'ForeName': 'Yinghua', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Nutrition, Chinese PLA General Hospital, Beijing, PR China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': 'Department of Nutrition, Chinese PLA General Hospital, Beijing, PR China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Nutrition, Chinese PLA General Hospital, Beijing, PR China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Nutrition, Chinese PLA General Hospital, Beijing, PR China.'}, {'ForeName': 'Huizi', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition, PLA Rocket Force Characteristic Medical Center, Beijing, PR China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition, Air Force Medical Center, PLA, Beijing, PR China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Nutrition, Chinese PLA General Hospital, Beijing, PR China.'}, {'ForeName': 'Xueyan', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Nutrition, Chinese PLA General Hospital, Beijing, PR China.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Nutrition, Chinese PLA General Hospital, Beijing, PR China.'}, {'ForeName': 'Aijing', 'Initials': 'A', 'LastName': 'Kong', 'Affiliation': 'Department of Nutrition, Chinese PLA General Hospital, Beijing, PR China.'}]",International journal of food sciences and nutrition,['10.1080/09637486.2019.1673703']
1529,31575824,The Impact of a Foot-Toe Orthosis on Dynamic Balance: An Exploratory Randomized Control Trial.,"CONTEXT


The influence of custom and over-the-counter foot orthoses on dynamic balance has been investigated in the past. However, there has not been an exploration of the use of a foot-toe orthosis for improving balance. The ability of clinicians to influence balance could have important implications for injury prevention and rehabilitation.
OBJECTIVE


To determine the impact of a foot-toe orthosis on dynamic balance in healthy, young adults.
DESIGN


Randomized control trial.
SETTING


Athletic training laboratory.
PARTICIPANTS


In total, 64 healthy, recreationally active participants aged 18-29 years were randomly allocated to one of the following groups: the foot-toe orthosis and laboratory-issued shoe group, the laboratory-issued shoe only (SO) group, or the control group.
INTERVENTIONS


Subjects in the intervention group wore the foot-toe orthosis and laboratory-issued shoe with activities of daily living for 4 weeks. Subjects in the SO intervention group wore the laboratory-issued shoe with activities of daily living for 4 weeks. Participants in the control group did not receive any intervention.
MAIN OUTCOME MEASURES


The instrumented version of the Star Excursion Balance Test, known as the Lower Quarter Y-Balance Test, was used to quantify the dynamic balance at baseline and follow-up. Reaches were normalized for leg length.
RESULTS


There were statistically significant differences in postintervention scores on the Lower Quarter Y-Balance Test for both the dominant (P = .03, effect size = 0.84; 95% confidence interval, 0.25 to 1.43) and nondominant (P = .002, effect size = 0.74; 95% confidence interval, 0.15 to 1.32) legs when comparing dynamic balance scores of the foot-toe orthosis and laboratory-issued shoe group with the SO and control groups. No significant differences were observed when comparing dynamic balance between the SO and control groups.
CONCLUSIONS


A 4-week intervention with a foot-toe orthosis and laboratory-issued shoe resulted in improved dynamic balance in a healthy young adult population. These findings suggest a novel intervention for increasing balance.",2019,"There were statistically significant differences in postintervention scores on the Lower Quarter Y-Balance Test for both the dominant (P = .03, effect size = 0.84; 95% confidence interval, 0.25 to 1.43) and nondominant (P = .002, effect size = 0.74; 95% confidence interval, 0.15 to 1.32) legs when comparing dynamic balance scores of the foot-toe orthosis and laboratory-issued shoe group with the SO and control groups.","['Athletic training laboratory', '64 healthy, recreationally active participants aged 18-29 years', 'healthy young adult population', 'healthy, young adults']","['foot-toe orthosis and laboratory-issued shoe group, the laboratory-issued shoe only (SO) group, or the control group', 'foot-toe orthosis', 'Subjects in the intervention group wore the foot-toe orthosis and laboratory-issued shoe with activities of daily living for 4 weeks']","['dynamic balance', 'Dynamic Balance', 'postintervention scores']","[{'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0040357', 'cui_str': 'Toes'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0185506', 'cui_str': 'Shoeing'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",64.0,0.0670013,"There were statistically significant differences in postintervention scores on the Lower Quarter Y-Balance Test for both the dominant (P = .03, effect size = 0.84; 95% confidence interval, 0.25 to 1.43) and nondominant (P = .002, effect size = 0.74; 95% confidence interval, 0.15 to 1.32) legs when comparing dynamic balance scores of the foot-toe orthosis and laboratory-issued shoe group with the SO and control groups.","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Stanek', 'Affiliation': ''}]",Journal of sport rehabilitation,['10.1123/jsr.2017-0321']
1530,31828490,Effects of an exercise-based oncology rehabilitation program and age on strength and physical function in cancer survivors.,"PURPOSE


Cancer therapy diminishes strength and physical function in cancer survivors. Whether oncology rehabilitation (OR) exercise training following therapy can correct these deficits, and whether its effectiveness differs by age, is not clear. We examine the utility of a clinically based, 12-week, combined aerobic and resistance training intervention on muscle strength and physical function in two age groups of cancer survivors.
METHODS


Strength and physical function measures were assessed in middle-aged (45 to 64 years) and older (≥ 65 years) patients following treatment for stage 0-III cancer before and after the OR training program.
RESULTS


Older patients had lower physical function compared to middle-aged patients across a range of subjective and objective measures at baseline, and exercise improved all indices of physical function and strength in both age groups. Compared to the middle-aged individuals, older participants tended to have less improvement leg strength and the 5 time sit to stand (5TSTS) test as a result of OR. In models predicting post-intervention measures, older age contributed to less improvement in walking distance and power as well as the 5TSTS test.
CONCLUSION


Prior to beginning the OR exercise program, middle-aged patients had higher physical function compared to older patients. However, a 12-week aerobic and resistance training intervention improved physical function across both age groups, although older age did limit responsiveness in some physical function measures. The physical function and strength of middle-aged and older cancer survivors improve in response to an exercise-based OR program after cancer treatment.",2019,"RESULTS


Older patients had lower physical function compared to middle-aged patients across a range of subjective and objective measures at baseline, and exercise improved all indices of physical function and strength in both age groups.","['cancer survivors', 'Older patients', 'middle-aged and older cancer survivors', 'middle-aged (45 to 64 years) and older (≥ 65 years', 'two age groups of cancer survivors']","['aerobic and resistance training intervention', 'oncology rehabilitation (OR) exercise training', 'combined aerobic and resistance training intervention', 'exercise-based oncology rehabilitation program', 'exercise-based OR program']","['muscle strength and physical function', 'physical function and strength', 'physical function', 'improvement leg strength', 'walking distance and power as well as the 5TSTS test', 'strength and physical function']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.015497,"RESULTS


Older patients had lower physical function compared to middle-aged patients across a range of subjective and objective measures at baseline, and exercise improved all indices of physical function and strength in both age groups.","[{'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dittus', 'Affiliation': 'Department of Internal Medicine, Vermont Center on Behavior and Health, University of Vermont, Given E-214, 89 Beaumont Ave, Burlington, VT, 05405, USA. kim.dittus@vtmednet.org.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Toth', 'Affiliation': 'Departments of Internal Medicine and Molecular Physiology and Biophysics, College of Medicine, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Priest', 'Affiliation': 'Medical Biostatistics Unit, University of Vermont, Burlington, VT, 05405, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Internal Medicine, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Kokinda', 'Affiliation': 'Department of Rehabilitation and Movement Science, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Ades', 'Affiliation': 'Department of Internal Medicine, Vermont Center on Behavior and Health, University of Vermont, Given E-214, 89 Beaumont Ave, Burlington, VT, 05405, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05163-8']
1531,32119035,Dose-Ranging Effect of Adjunctive Oral Cannabidiol vs Placebo on Convulsive Seizure Frequency in Dravet Syndrome: A Randomized Clinical Trial.,"Importance


Clinical evidence supports effectiveness of cannabidiol for treatment-resistant seizures in Dravet syndrome, but this trial is the first to evaluate the 10-mg/kg/d dose.
Objective


To evaluate the efficacy and safety of a pharmaceutical formulation of cannabidiol, 10 and 20 mg/kg/d, vs placebo for adjunctive treatment of convulsive seizures in patients with Dravet syndrome.
Design, Setting, and Participants


This double-blind, placebo-controlled, randomized clinical trial (GWPCARE2) recruited patients from April 13, 2015, to November 10, 2017, with follow-up completed on April 9, 2018. Of 285 patients screened from 38 centers in the United States, Spain, Poland, the Netherlands, Australia, and Israel, 86 were excluded, and 199 were randomized. Patients were aged 2 to 18 years with a confirmed diagnosis of Dravet syndrome and at least 4 convulsive seizures during the 4-week baseline period while receiving at least 1 antiepileptic drug. Data were analyzed from November 16 (date of unblinding) to December 13 (date of final outputs), 2018, based on intention to treat and per protocol.
Interventions


Patients received cannabidiol oral solution at a dose of 10 or 20 mg/kg per day (CBD10 and CBD20 groups, respectively) or matched placebo in 2 equally divided doses for 14 weeks. All patients, caregivers, investigators, and individuals assessing data were blinded to group assignment.
Main Outcomes and Measures


The primary outcome was change from baseline in convulsive seizure frequency during the treatment period. Secondary outcomes included change in all seizure frequency, proportion with at least a 50% reduction in convulsive seizure activity, and change in Caregiver Global Impression of Change score.
Results


Of 198 eligible patients (mean [SD] age, 9.3 [4.4] years; 104 female [52.5%]), 66 were randomized to the CBD10 group, 67 to the CBD20 group, and 65 to the placebo group, and 190 completed treatment. The percentage reduction from baseline in convulsive seizure frequency was 48.7% for CBD10 group and 45.7% for the CBD20 group vs 26.9% for the placebo group; the percentage reduction from placebo was 29.8% (95% CI, 8.4%-46.2%; P = .01) for CBD10 group and 25.7% (95% CI, 2.9%-43.2%; P = .03) for the CBD20 group. The most common adverse events were decreased appetite, diarrhea, somnolence, pyrexia, and fatigue. Five patients in the CBD20 group discontinued owing to adverse events. Elevated liver transaminase levels occurred more frequently in the CBD20 (n = 13) than the CBD10 (n = 3) group, with all affected patients given concomitant valproate sodium.
Conclusions and Relevance


Adjunctive cannabidiol at doses of 10 and 20 mg/kg/d led to similar clinically relevant reductions in convulsive seizure frequency with a better safety and tolerability profile for the 10-mg/kg/d dose in children with treatment-resistant Dravet syndrome. Dose increases of cannabidiol to greater than 10 mg/kg/d should be tailored to individual efficacy and safety.
Trial Registration


ClinicalTrials.gov Identifier: NCT02224703.",2020,"Elevated liver transaminase levels occurred more frequently in the CBD20 (n = 13) than the CBD10 (n = 3) group, with all affected patients given concomitant valproate sodium.
","['198 eligible patients (mean [SD] age, 9.3 [4.4] years; 104 female [52.5%]), 66 were randomized to the CBD10 group, 67 to the CBD20 group, and 65 to the placebo group, and 190 completed treatment', 'children with treatment-resistant Dravet syndrome', '285 patients screened from 38 centers in the United States, Spain, Poland, the Netherlands, Australia, and Israel, 86 were excluded, and 199 were randomized', 'Patients were aged 2 to 18 years with a confirmed diagnosis of Dravet syndrome and at least 4 convulsive seizures during the 4-week baseline period while receiving at least 1 antiepileptic drug', 'patients with Dravet syndrome', 'Dravet Syndrome', 'patients from April 13, 2015, to November 10, 2017, with follow-up completed on April 9, 2018']","['cannabidiol', 'Adjunctive Oral Cannabidiol vs Placebo', 'placebo', 'CBD20', 'cannabidiol oral solution', 'valproate sodium']","['Elevated liver transaminase levels', 'efficacy and safety', 'appetite, diarrhea, somnolence, pyrexia, and fatigue', 'convulsive seizure frequency', 'change in all seizure frequency, proportion with at least a 50% reduction in convulsive seizure activity, and change in Caregiver Global Impression of Change score', 'safety and tolerability profile']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517802', 'cui_str': '52.5 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0751122', 'cui_str': 'Myoclonic Epilepsy, Severe, Of Infancy'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0751494', 'cui_str': 'Convulsive Seizures'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0003299', 'cui_str': 'Antiepileptic Agents'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0991536', 'cui_str': 'Oral Solution'}, {'cui': 'C0037567', 'cui_str': 'Sodium Valproate'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0751494', 'cui_str': 'Convulsive Seizures'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",198.0,0.58063,"Elevated liver transaminase levels occurred more frequently in the CBD20 (n = 13) than the CBD10 (n = 3) group, with all affected patients given concomitant valproate sodium.
","[{'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Miller', 'Affiliation': ""Department of Neurology, Nicklaus Children's Hospital, Miami, Florida.""}, {'ForeName': 'Ingrid E', 'Initials': 'IE', 'LastName': 'Scheffer', 'Affiliation': ""Epilepsy Research Centre, The University of Melbourne at Austin Health and the Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'Gunning', 'Affiliation': 'Stichting Epilepsie Instellingen Nederland, Zwolle, the Netherlands.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Sanchez-Carpintero', 'Affiliation': 'Pediatric Neurology Unit, Clínica Universidad de Navarra, Navarra Institute for Health Research, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gil-Nagel', 'Affiliation': 'Department of Neurology, Hospital Ruber Internacional, Madrid, Spain.'}, {'ForeName': 'M Scott', 'Initials': 'MS', 'LastName': 'Perry', 'Affiliation': ""Jane and John Justin Neurosciences Center, Cook Children's Medical Center, Ft Worth, Texas.""}, {'ForeName': 'Russell P', 'Initials': 'RP', 'LastName': 'Saneto', 'Affiliation': ""Neuroscience Institute, Division of Pediatric Neurology, Department of Neurology, Seattle Children's Hospital and University of Washington, Seattle.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Checketts', 'Affiliation': 'GW Research, Ltd, Cambridge, United Kingdom.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Dunayevich', 'Affiliation': 'Greenwich Biosciences, Inc, Carlsbad, California.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Knappertz', 'Affiliation': 'Greenwich Biosciences, Inc, Carlsbad, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2020.0073']
1532,31836146,Evaluation of a journal club preparatory session on student confidence for a graded journal club.,"INTRODUCTION


The purpose of this project was to describe and assess the impact of a journal club preparatory session on advanced pharmacy practice experience (APPE) student confidence pre- and post-graded journal club.
METHODS


A two-hour journal club preparatory session was implemented for APPE students on rotation with two clinical faculty members. The pre-assessment instructional activity was conducted the first week of each rotation; faculty members took turns working through a randomized-controlled clinical trial, highlighting and discussing key points based on their backgrounds and training. In week three, each student completed a graded journal club assignment that required a written critique and verbal presentation. Student confidence was evaluated pre-and post-activities; the pre-survey was completed prior to the journal club preparatory session and the post-survey was completed in week six.
RESULTS


Thirty-two APPE rotation students participated in journal club activities, with 26 students providing complete data (81% response rate). Mean scores on confidence across all 11 items improved on the post-survey and were statistically significant (p < 0.05). There were no statistically significant differences on change in confidence based on gender, age, with or without an acute care rotation, and with or without previous journal club experience.
CONCLUSION


A journal club preparatory session that walks students through a process prior to a graded activity helps to increase student self-reported confidence.",2019,"There were no statistically significant differences on change in confidence based on gender, age, with or without an acute care rotation, and with or without previous journal club experience.
","['APPE students on rotation with two clinical faculty members', 'advanced pharmacy practice experience (APPE', 'student confidence for a graded journal club', 'Thirty-two APPE rotation students']",['journal club preparatory session'],"['journal club activities', 'Mean scores on confidence']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0015538', 'cui_str': 'Nurse teacher'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0450357', 'cui_str': '32'}]","[{'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}]","[{'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.0239235,"There were no statistically significant differences on change in confidence based on gender, age, with or without an acute care rotation, and with or without previous journal club experience.
","[{'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Gurney', 'Affiliation': 'Associate Professor of Pharmacy Practice, Midwestern University College of Pharmacy, Glendale, AZ 85308, United States. Electronic address: mgurney@midwestern.edu.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Buckley', 'Affiliation': 'Associate Professor of Pharmacy Practice, Midwestern University College of Pharmacy, Glendale, AZ 85308, United States.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Karr', 'Affiliation': 'Associate Professor of Pharmacy Practice, Midwestern University College of Pharmacy, Glendale, AZ 85308, United States.'}]",Currents in pharmacy teaching & learning,['10.1016/j.cptl.2019.09.011']
1533,32413812,Effects of a mindfulness based behavioral intervention for young adults with childhood maltreatment history on hippocampal morphometry: a pilot MRI study with voxel-based morphometry.,"Childhood maltreatment has long lasting impacts on neural development of the hippocampus, which is important for learning and memory. The present study aimed to assess the effects of a mindfulness based intervention on hippocampal morphometry and episodic memory in this population. We administered MRI, psychological questionnaires and an episodic memory task to 21 participants (5 males) before and after a mindfulness-based behavioral intervention, compared to 21 participants (7 males) on the waiting list. Changes in Gray Matter Volume (GMV) in bilateral hippocampi were analyzed with Voxel-Based Morphometry (VBM). One cluster was identified in the right hippocampus with a group by time interaction effect that consisted of 130 contiguous voxels but fell short of significance with full FDR correction (p = 0.077). GMV in this cluster increased by 0.76% in the mindfulness group and decreased by 0.78% in the control group. Within the mindfulness group, changes in hippocampal GMV were negatively associated with changes in perceived stress and depression severity and positively associated with enhancement in performance accuracy on the episodic memory task. Findings from this pilot study suggest that a mindfulness-based intervention may lead to an increase in partial hippocampal GMV with associated symptom reduction and improvement in episodic memory.",2020,GMV in this cluster increased by 0.76% in the mindfulness group and decreased by 0.78% in the control group.,"['21 participants (5 males) before and after a', 'young adults with childhood maltreatment history on hippocampal morphometry']","['mindfulness based intervention', 'mindfulness-based behavioral intervention', 'mindfulness based behavioral intervention']","['perceived stress and depression severity', 'GMV', 'hippocampal morphometry and episodic memory', 'episodic memory', 'hippocampal GMV', 'partial hippocampal GMV', 'Gray Matter Volume (GMV']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0200760', 'cui_str': 'Morphometric analysis'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0200760', 'cui_str': 'Morphometric analysis'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0728938', 'cui_str': 'Partial'}]",130.0,0.0170544,GMV in this cluster increased by 0.76% in the mindfulness group and decreased by 0.78% in the control group.,"[{'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Joss', 'Affiliation': 'Developmental Biopsychiatry Research Program, McLean Hospital, Belmont, MA, USA; Department of Psychiatry, Massachusetts General Hospital, USA; Department of Psychiatry, Harvard Medical School, Boston, USA. Electronic address: djoss@mclean.harvard.edu.'}, {'ForeName': 'Sara W', 'Initials': 'SW', 'LastName': 'Lazar', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, USA; Department of Psychiatry, Harvard Medical School, Boston, USA.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Teicher', 'Affiliation': 'Developmental Biopsychiatry Research Program, McLean Hospital, Belmont, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, USA.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111087']
1534,31898118,Short-Term VA Health Care Expenditures Following a Health Risk Assessment and Coaching Trial.,"BACKGROUND


Short-term health care costs following completion of health risk assessments and coaching programs in the VA have not been assessed.
OBJECTIVE


To compare VA health care expenditures among veterans who participated in a behavioral intervention trial that randomized patients to complete a HRA followed by health coaching (HRA + coaching) or to complete the HRA without coaching (HRA-alone).
DESIGN


Four-hundred seventeen veterans at three Veterans Affairs (VA) Medical Centers or Clinics were randomized to HRA + coaching or HRA-alone. Veterans randomized to HRA-alone (n = 209) were encouraged to discuss HRA results with their primary care team, while veterans randomized to HRA + coaching (n = 208) received two brief telephone-delivered health coaching calls.
PARTICIPANTS


We included 411 veterans with available cost data.
MAIN MEASURES


Total VA health expenditures 6 months following trial enrollment were estimated using a generalized linear model with a gamma distribution and log link function. In exploratory analysis, model-based recursive partitioning was used to determine whether the intervention effect on short-term costs differed among any patient subgroups.
KEY RESULTS


Most participants were male (85%); mean age was 56, and mean body mass index was 34. From the generalized linear model, 6-month estimated mean total VA expenditures were similar ($8665 for HRA + coaching vs $9900 for HRA-alone, p = 0.25). In exploratory subgroup analysis, among unemployed veterans with good sleep and fair or poor perceived health, mean observed expenditures in the HRA + coaching group were higher than in the HRA-alone group ($12,814 vs $7971). Among unemployed veterans with good sleep and good general health, mean observed expenditures in the HRA + coaching group were lower than in the HRA-alone group ($5082 vs $11,612).
CONCLUSIONS


Compared to completing and receiving HRA results, working with health coaches to set actionable health behavior change goals following HRA completion did not reduce short-term health expenditures.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT01828567.",2020,"Among unemployed veterans with good sleep and good general health, mean observed expenditures in the HRA + coaching group were lower than in the HRA-alone group ($5082 vs $11,612).
","['veterans who participated in a behavioral intervention trial that randomized patients to complete a', 'Medical Centers or Clinics', 'Four-hundred seventeen veterans at three Veterans Affairs (VA', '411 veterans with available cost data', 'n = 209', 'Most participants were male (85%); mean age was 56, and mean body mass index was 34']","['HRA-alone', 'HRA + coaching', 'HRA followed by health coaching (HRA + coaching) or to complete the HRA without coaching (HRA-alone', 'telephone-delivered health coaching calls', 'HRA + coaching or HRA-alone']",['mean total VA expenditures'],"[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}]",411.0,0.0415601,"Among unemployed veterans with good sleep and good general health, mean observed expenditures in the HRA + coaching group were lower than in the HRA-alone group ($5082 vs $11,612).
","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Sloan', 'Affiliation': 'Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), , Durham Veterans Affairs Health Care System, Durham, NC, USA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Stechuchak', 'Affiliation': 'Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), , Durham Veterans Affairs Health Care System, Durham, NC, USA.'}, {'ForeName': 'Maren K', 'Initials': 'MK', 'LastName': 'Olsen', 'Affiliation': 'Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), , Durham Veterans Affairs Health Care System, Durham, NC, USA.'}, {'ForeName': 'Eugene Z', 'Initials': 'EZ', 'LastName': 'Oddone', 'Affiliation': 'Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), , Durham Veterans Affairs Health Care System, Durham, NC, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Damschroder', 'Affiliation': 'Ann Arbor VA HSR&D/Center for Clinical Management Research, P.O. Box 130170, Ann Arbor, MI, USA.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Maciejewski', 'Affiliation': 'Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), , Durham Veterans Affairs Health Care System, Durham, NC, USA. matthew.maciejewski@va.gov.'}]",Journal of general internal medicine,['10.1007/s11606-019-05455-z']
1535,31578954,"Bone mineral density in virologically suppressed people aged 60 years or older with HIV-1 switching from a regimen containing tenofovir disoproxil fumarate to an elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide single-tablet regimen: a multicentre, open-label, phase 3b, randomised trial.","BACKGROUND


Tenofovir alafenamide is associated with less renal and bone toxicity than tenofovir disoproxil fumarate and might improve the long-term safety of antiretroviral therapy. We aimed to investigate the effect on bone mineral density of switching from a regimen containing tenofovir disoproxil fumarate to one containing tenofovir alafenamide in participants aged 60 years and older.
METHODS


We did a prospective, open-label, multicentre, randomised trial in 36 European centres. Participants were virologically suppressed (HIV-1 RNA <50 copies per mL), aged 60 years or older, on a tenofovir disoproxil fumarate-containing regimen and were randomly assigned (2:1) via an interactive web-response system to open-label elvitegravir (150 mg), cobicistat (150 mg), emtricitabine (200 mg), and tenofovir alafenamide (10 mg) daily or continued therapy containing tenofovir disoproxil fumarate (300 mg). Participants were stratified by spine and hip bone mineral density categories. Primary endpoints were change from baseline to week 48 in spine and hip bone mineral density with a null hypothesis of zero between-group difference tested at a significance level of 0·05. This study was registered with ClinicalTrials.gov, NCT02616783.
FINDINGS


Between Dec 22, 2015, and March 21, 2018, 167 participants were randomly assigned to elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (n=111 [66%]) or tenofovir disoproxil fumarate (n=56 [34%]). One participant in the elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide group did not receive treatment and was excluded from all analyses. At week 48, the mean percentage change in spine bone mineral density was 2·24% (SD 3·27) in the elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide group and -0·10% (3·39) in the tenofovir disoproxil fumarate group (between-group difference 2·43% [95% CI 1·34-3·52]; p<0·0001), and mean percentage change in hip bone mineral density was 1·33% (2·20) in the elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide group and -0·73% (3·21) in the tenofovir disoproxil fumarate group (difference 2·04% [1·17-2·90]; p<0·0001). The most common adverse events were nasopharyngitis (12 [11%]), back pain (nine [8%]), and diarrhoea (eight [7%]) in the elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide group; and bronchitis (six [11%]), vitamin D deficiency (four [7%]), and arthralgia (four [7%]) in the tenofovir disoproxil fumarate group. 22 (20%) participants in the elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide group and one (2%) participant in the tenofovir disoproxil fumarate group had an adverse event that was considered to be related to treatment. No treatment-related serious adverse events were observed. The proportions of adverse events leading to premature treatment discontinuation were similar between groups (four [4%] in the elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide group; and one (2%) in the tenofovir disoproxil fumarate group).
INTERPRETATION


The significantly improved bone mineral density, overall safety, and efficacy data show the feasibility of switching from a regimen containing tenofovir disoproxil fumarate to elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in virologically suppressed people living with HIV aged 60 years or older.
FUNDING


Gilead Sciences.",2019,"The proportions of adverse events leading to premature treatment discontinuation were similar between groups (four [4%] in the elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide group; and one (2%) in the tenofovir disoproxil fumarate group).
","['Between Dec 22, 2015, and March 21, 2018', 'virologically suppressed people living with HIV aged 60 years or older', '167 participants were randomly assigned to', 'virologically suppressed people aged 60 years or older with HIV-1 switching from a regimen containing', '36 European centres', 'participants aged 60 years and older', 'Participants were virologically suppressed (HIV-1 RNA <50 copies per mL), aged 60 years or older, on a']","['tenofovir disoproxil fumarate to an elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide single-tablet regimen', 'tenofovir disoproxil fumarate-containing regimen and were randomly assigned (2:1) via an interactive web-response system to open-label elvitegravir (150 mg), cobicistat (150 mg), emtricitabine (200 mg), and tenofovir alafenamide (10 mg) daily or continued therapy containing tenofovir disoproxil fumarate', 'tenofovir alafenamide', 'tenofovir disoproxil fumarate to elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide', 'elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide', 'tenofovir disoproxil fumarate']","['spine and hip bone mineral density', 'vitamin D deficiency', 'Bone mineral density', 'diarrhoea', 'bone mineral density, overall safety, and efficacy data', 'bone mineral density', 'back pain', 'arthralgia', 'hip bone mineral density', 'serious adverse events', 'renal and bone toxicity', 'spine bone mineral density']","[{'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C2606637', 'cui_str': 'elvitegravir'}, {'cui': 'C3177235', 'cui_str': 'cobicistat'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",167.0,0.228122,"The proportions of adverse events leading to premature treatment discontinuation were similar between groups (four [4%] in the elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide group; and one (2%) in the tenofovir disoproxil fumarate group).
","[{'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Maggiolo', 'Affiliation': 'Division of Infectious Diseases, ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Giuliano', 'Initials': 'G', 'LastName': 'Rizzardini', 'Affiliation': 'Division of Infectious Diseases, Luigi Sacco Hospital, ASST Fatebenefratelli Sacco, Milan, Italy; School of Clinical Medicine, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Raffi', 'Affiliation': 'Department of Infectious and Tropical Diseases and CIC 1413, INSERM, University Hospital, Nantes, France.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Pulido', 'Affiliation': 'HIV Unit, University Hospital 12 de Octubre, Imas12, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Maria Gracia', 'Initials': 'MG', 'LastName': 'Mateo-Garcia', 'Affiliation': 'Infectious Diseases Unit, Hospital de la Santa Creu I Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Department of Infectious Diseases, Saint Louis Hospital, University Paris Diderot, Paris, France.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Ong', 'Affiliation': 'Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Trust, Newcastle, UK.'}, {'ForeName': 'Yongwu', 'Initials': 'Y', 'LastName': 'Shao', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Piontkowsky', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Moupali', 'Initials': 'M', 'LastName': 'Das', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'McNicholl', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haubrich', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA. Electronic address: richard.haubrich@gilead.com.'}]",The lancet. HIV,['10.1016/S2352-3018(19)30195-X']
1536,32024491,Model of goal directed behavior for limiting Latino preschoolers' television viewing: validity and reliability.,"BACKGROUND


Accurately measuring parents' attitudes and beliefs regarding limiting their children's TV viewing is important to inform the design and evaluation of effective interventions. This manuscript assesses the internal consistency reliability, test-retest reliability, convergent validity, and construct validity of the Model of Goal Directed Behavior (MGDB) scales among parents of Latino preschoolers to characterize Latino parents' attitudes and beliefs toward limiting their preschoolers' TV viewing.
METHOD


Participants included parents of Latino preschoolers in the United States, 3-5 years old (n = 186). Parents completed a socio-demographic survey and the 105-item MGDB questionnaire (Attitudes, Perceived Positive/Negative Behavioral Control, Subjective Norms, Positive and Negative Anticipated Emotions, Habits, Self-Efficacy, Desires, and Intentions surrounding their child's TV viewing) which was used to measure internal consistency reliability and construct validity. A subsample of participants completed the questionnaire twice to measure test-retest reliability. Further, parents completed a 7-day TV viewing diary for their preschooler, and a TV parenting practices questionnaire as measures of convergent validity.
RESULTS


Internal consistency reliability was generally acceptable for the MGDB scales (Cronbach's alphas> 0.7), except for the Desires scale, which was revealed to have two factors and the Attitudes and Perceived Behavioral Control scales. Test-retest reliability over 2 months had negligible to moderate correlations (r's = 0.28 to 0.61). Two structural equation models were conducted. One yielded acceptable model fit (x 2  (97) = 113.65, p = .119) and the other had questionable model fit (x 2  (97) = 125.39; p = .028). Testing convergent validity, only two MGDB scales (Habits and Self-Efficacy) were positively correlated with the TV parenting practices questionnaire (r's = 0.33 to 0.51), and none were meaningfully correlated with preschoolers' mean daily TV viewing.
CONCLUSIONS


Initial reliability and validity for some of the MGDB scales appear acceptable among parents of Latino preschoolers. Refinement of the instrument and testing among larger samples is necessary to fully evaluate psychometric properties. This instrument may be useful for characterizing Latino parents' attitudes and beliefs toward limiting their preschoolers' TV viewing and informing future TV reduction interventions.
TRIAL REGISTRATION


Clinical Trials NCT01216306 Registered October 6, 2010.",2020,"RESULTS


Internal consistency reliability was generally acceptable for the MGDB scales (Cronbach's alphas> 0.7), except for the Desires scale, which was revealed to have two factors and the Attitudes and Perceived Behavioral Control scales.","['parents of Latino preschoolers', 'Participants included parents of Latino preschoolers in the United States, 3-5\u2009years old (n\u2009=\u2009186']",[],"['MGDB scales', 'Test-retest reliability', 'TV parenting practices questionnaire', 'Goal Directed Behavior (MGDB) scales', 'MGDB scales (Habits and Self-Efficacy', ""socio-demographic survey and the 105-item MGDB questionnaire (Attitudes, Perceived Positive/Negative Behavioral Control, Subjective Norms, Positive and Negative Anticipated Emotions, Habits, Self-Efficacy, Desires, and Intentions surrounding their child's TV viewing"", 'Attitudes and Perceived Behavioral Control scales']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0011296', 'cui_str': 'Demographic Survey'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1282914', 'cui_str': 'Circumscribed'}, {'cui': 'C0449911', 'cui_str': 'View'}]",2.0,0.0167024,"RESULTS


Internal consistency reliability was generally acceptable for the MGDB scales (Cronbach's alphas> 0.7), except for the Desires scale, which was revealed to have two factors and the Attitudes and Perceived Behavioral Control scales.","[{'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Ogren', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, 1285 Franz Hall, Box 951563, Los Angeles, CA, 90095-1563, USA. Mogren@ucla.edu.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Baranowski', 'Affiliation': ""USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine, Houston, TX, USA.""}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Lowry', 'Affiliation': ""Center for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Mendoza', 'Affiliation': ""Center for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, WA, USA.""}]",BMC public health,['10.1186/s12889-020-8268-x']
1537,32412796,Glucagon-like peptide-1 (GLP-1)-based receptor agonists as a treatment for Parkinson's disease.,"Introduction : Accumulating evidence supports the evaluation of glucagon-like peptide-1 (GLP-1) receptor (R) agonists for the treatment of the underlying pathology causing Parkinson's Disease (PD). Not only are these effects evident in models of PD and other neurodegenerative disorders but recently in a randomized, double-blind, placebo-controlled clinical trial, a GLP-1R agonist has provided improved cognition motor functions in humans with moderate PD. Areas covered : In this mini-review, we describe the development of GLP-1R agonists and their potential therapeutic value in treating PD. Many GLP-1R agonists are FDA approved for the treatment of metabolic disorders, and hence can be rapidly repositioned for PD. Furthermore, we present preclinical data offering insights into the use of monomeric dual- and tri-agonist incretin-based mimetics for neurodegenerative disorders. These drugs combine active regions of GLP-1 with those of glucose-dependent insulinotropic peptide (GIP) and/or glucagon (Gcg). Expert opinion : GLP-1Ragonists offer a complementary and enhanced therapeutic value to other drugs used to treat PD. Moreover, the use of the dual- or tri-agonist GLP-1-based mimetics may provide combinatory effects that are even more powerful than GLP-1R agonism alone. We advocate for further investigations into the repurposing of GLP-1R agonists and the development of classes of multi-agonists for PD treatment.",2020,"Many GLP-1R agonists are FDA approved for the treatment of metabolic disorders, and hence can be rapidly repositioned for PD.","[""Parkinson's disease"", 'humans with moderate PD']","['Glucagon-like peptide-1 (GLP-1)-based receptor agonists', 'placebo']",['cognition motor functions'],"[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}]",,0.0631103,"Many GLP-1R agonists are FDA approved for the treatment of metabolic disorders, and hence can be rapidly repositioned for PD.","[{'ForeName': 'Elliot J', 'Initials': 'EJ', 'LastName': 'Glotfelty', 'Affiliation': 'Translational Gerontology Branch, Intramural Research Program, National Institute on Aging, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Olson', 'Affiliation': 'Department of Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Tobias E', 'Initials': 'TE', 'LastName': 'Karlsson', 'Affiliation': 'Department of Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Yazhou', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Translational Gerontology Branch, Intramural Research Program, National Institute on Aging, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'Nigel H', 'Initials': 'NH', 'LastName': 'Greig', 'Affiliation': 'Translational Gerontology Branch, Intramural Research Program, National Institute on Aging, National Institutes of Health, Baltimore, MD, USA.'}]",Expert opinion on investigational drugs,['10.1080/13543784.2020.1764534']
1538,29909789,Prolonged grief disorder: clinical utility of ICD-11 diagnostic guidelines.,"BACKGROUND


The World Health Organization (WHO) International Classification of Disease (ICD-11) is expected to include a new diagnosis for prolonged grief disorder (ICD-11PGD). This study examines the validity and clinical utility of the ICD-11PGD guideline by testing its performance in a well-characterized clinical sample and contrasting it with a very different criteria set with the same name (PGDPLOS).
METHODS


We examined data from 261 treatment-seeking participants in the National Institute of Mental Health (NIMH)-sponsored multicenter clinical trial to determine the rates of diagnosis using the ICD-11PGD guideline and compared these with diagnosis using PGDPLOS criteria.
RESULTS


The ICD-11PGD guideline identified 95.8% [95% confidence interval (CI) 93.3-98.2%] of a treatment-responsive cohort of patients with distressing and impairing grief. PGDPLOS criteria identified only 59.0% (95% CI 53.0-65.0%) and were more likely to omit those who lost someone other than a spouse, were currently married, bereaved by violent means, or not diagnosed with co-occurring depression. Those not diagnosed by PGDPLOS criteria showed the same rate of treatment response as those who were diagnosed.
CONCLUSIONS


The ICD-11PGD diagnostic guideline showed good performance characteristics in this sample, while PGDPLOS criteria did not. Limitations of the research sample used to derive PGDPLOS criteria may partly explain their poor performance in a more diverse clinical sample. Clinicians and researchers need to be aware of the important difference between these two identically named diagnostic methods.",2019,"PGDPLOS criteria identified only 59.0% (95% CI 53.0-65.0%) and were more likely to omit those who lost someone other than a spouse, were currently married, bereaved by violent means, or not diagnosed with co-occurring depression.",['261 treatment-seeking participants in the National Institute of Mental Health (NIMH)-sponsored multicenter clinical trial'],['ICD-11PGD guideline'],[],"[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027466', 'cui_str': 'National Institute of Mental Health'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0020725', 'cui_str': 'I-cell disease'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]",[],,0.0821731,"PGDPLOS criteria identified only 59.0% (95% CI 53.0-65.0%) and were more likely to omit those who lost someone other than a spouse, were currently married, bereaved by violent means, or not diagnosed with co-occurring depression.","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Mauro', 'Affiliation': 'Department of Biostatistics,Mailman School of Public Health, Columbia University,722 West 168th Street, 6th floor, New York, NY 10032,USA.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Reynolds', 'Affiliation': 'Department of Biostatistics,Mailman School of Public Health, Columbia University,722 West 168th Street, 6th floor, New York, NY 10032,USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Maercker', 'Affiliation': 'Department of Biostatistics,Mailman School of Public Health, Columbia University,722 West 168th Street, 6th floor, New York, NY 10032,USA.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Skritskaya', 'Affiliation': 'Department of Biostatistics,Mailman School of Public Health, Columbia University,722 West 168th Street, 6th floor, New York, NY 10032,USA.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Simon', 'Affiliation': 'Department of Biostatistics,Mailman School of Public Health, Columbia University,722 West 168th Street, 6th floor, New York, NY 10032,USA.'}, {'ForeName': 'Sidney', 'Initials': 'S', 'LastName': 'Zisook', 'Affiliation': 'Department of Biostatistics,Mailman School of Public Health, Columbia University,722 West 168th Street, 6th floor, New York, NY 10032,USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Lebowitz', 'Affiliation': 'Department of Biostatistics,Mailman School of Public Health, Columbia University,722 West 168th Street, 6th floor, New York, NY 10032,USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Cozza', 'Affiliation': 'Department of Biostatistics,Mailman School of Public Health, Columbia University,722 West 168th Street, 6th floor, New York, NY 10032,USA.'}, {'ForeName': 'M Katherine', 'Initials': 'MK', 'LastName': 'Shear', 'Affiliation': 'Department of Biostatistics,Mailman School of Public Health, Columbia University,722 West 168th Street, 6th floor, New York, NY 10032,USA.'}]",Psychological medicine,['10.1017/S0033291718001563']
1539,30328105,Enhanced availability of serotonin increases activation of unfatigued muscle but exacerbates central fatigue during prolonged sustained contractions.,"KEY POINTS


Animal preparations have revealed that moderate synaptic release of serotonin (5-HT) onto motoneurones enhances motor activity via activation of 5-HT 2  receptors, whereas intense release of 5-HT causes spillover of 5-HT to extrasynaptic 5-HT 1A  receptors on the axon initial segment to reduce motoneurone activity. We explored if increasing extracellular concentrations of endogenously released 5-HT (via the selective serotonin reuptake inhibitor paroxetine) influences the ability to perform unfatigued and fatigued maximal voluntary contractions in humans. Following the ingestion of paroxetine, voluntary muscle activation and torque generation increased during brief unfatigued maximal contractions. In contrast, the ability to generate maximal torque with increased 5-HT availability was compromised under fatigued conditions, which was consistent with paroxetine-induced reductions in motoneurone excitability and voluntary muscle activation. This is the first in vivo human study to provide evidence that 5-HT released onto the motoneurones could play a role in central fatigue.
ABSTRACT


Brief stimulation of the raphe-spinal pathway in the turtle spinal cord releases serotonin (5-HT) onto motoneurones to enhance excitability. However, intense release of 5-HT via prolonged stimulation results in 5-HT spillover to the motoneurone axon initial segment to activate inhibitory 5-HT 1A  receptors, thus providing a potential spinal mechanism for exercise-induced central fatigue. We examined how increased extracellular concentrations of 5-HT affect the ability to perform brief, as well as sustained, maximal voluntary contractions (MVCs) in humans. Paroxetine was used to enhance 5-HT concentrations by reuptake inhibition, and three studies were performed. Study 1 (n = 14) revealed that 5-HT reuptake inhibition caused an ∼4% increase in elbow flexion MVC. However, when maximal contractions were sustained, time-to-task failure was reduced and self-perceived fatigue was higher with enhanced availability of 5-HT. Study 2 (n = 11) used twitch interpolation to reveal that 5-HT-based changes in motor performance had a neural basis. Enhanced 5-HT availability increased voluntary activation for the unfatigued biceps brachii and decreased voluntary activation of the biceps brachii by 2-5% following repeated maximal elbow flexions. The final study (n = 8) investigated whether altered motoneurone excitability may contribute to 5-HT changes in voluntary activation. F-waves of the abductor digiti minimi (ADM) were unaffected by paroxetine for unfatigued muscle and marginally affected following a brief 2-s MVC. However, F-wave area and persistence were significantly decreased following a prolonged 60-s MVC of the ADM. Overall, high serotonergic drive provides a spinal mechanism by which higher concentrations of 5-HT may contribute to central fatigue.",2019,F-waves of the abductor digiti minimi (ADM) were unaffected by paroxetine for unfatigued muscle and marginally affected following a brief 2-s MVC.,['humans'],"['Paroxetine', 'paroxetine']","['voluntary activation of the biceps brachii', 'motoneurone excitability and voluntary muscle activation', '5-HT availability', 'time-to-task failure', 'elbow flexion MVC', '5-HT reuptake inhibition']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0070122', 'cui_str': 'Paroxetine'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",,0.0176821,F-waves of the abductor digiti minimi (ADM) were unaffected by paroxetine for unfatigued muscle and marginally affected following a brief 2-s MVC.,"[{'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Kavanagh', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Australia.'}, {'ForeName': 'Amelia J', 'Initials': 'AJ', 'LastName': 'McFarland', 'Affiliation': 'School of Pharmacy and Pharmacology, Griffith University, Gold Coast, Australia.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Perth, Australia.'}]",The Journal of physiology,['10.1113/JP277148']
1540,32412809,Practice improves court mobility and self-efficacy in tennis-specific wheelchair propulsion.,"Purpose:  Wheelchair tennis (WT) propulsion is uniquely characterized by the requirement for racket holding coupled with effective hand-rim contact. Thus, investigations involving strategies to enhance chair mobility skills are merited. The aim was to examine the effects of organized practice on WT match play responses and the impact of racket holding during practice. Materials and methods:  Following physiological profiling involving graded and peak exercise testing, 16 able-bodied (AB) participants performed bouts of WT match play interspersed with practice involving wheelchair mobility drills completed with (R) or without (NR) a tennis racket. A data logger recorded distance and speed. Self-efficacy was reported. Results and conclusions:  Significant main effects for match revealed higher post-practice overall and forwards distances ( p  < 0.05), peak ( p  < 0.005) and average ( p  < 0.05) speeds and self-efficacy (SE) ( p  = 0.001) were attained. During practice, lower distances and speeds were achieved with  R , with a lower physiological cost than NR. Practice increases court movement and SE with no associated increases in physiological cost. Changes represent enhanced court mobility. Differences between practice characteristics provide options for skill development and optimization of health outcomes.IMPLICATIONS FOR REHABILITATIONWheelchair tennis participation is likely to confer positive health effects in those with a disability or physical impairment.As chair propulsion combined with racket holding represents a complex skill challenge, novices may find the sport challenging to play.Tennis-specific mobility drills improve confidence and chair propulsion skill with likely crossover into tennis match play competence and ability.",2020,"Results and conclusions:  Significant main effects for match revealed higher post-practice overall and forwards distances ( p  < 0.05), peak ( p  < 0.005) and average ( p  < 0.05) speeds and self-efficacy (SE) ( p  = 0.001) were attained.",['tennis-specific wheelchair propulsion'],"['Wheelchair tennis (WT) propulsion', 'physiological profiling involving graded and peak exercise testing, 16 able-bodied (AB) participants performed bouts of WT match play interspersed with practice involving wheelchair mobility drills completed with (R) or without (NR) a tennis racket']","['speeds and self-efficacy (SE', 'physiological cost', 'court mobility and self-efficacy', 'Self-efficacy']","[{'cui': 'C0039515', 'cui_str': 'Tennis'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0043143', 'cui_str': 'Wheelchair'}]","[{'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C0039515', 'cui_str': 'Tennis'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0578264', 'cui_str': 'Wheelchair mobility'}, {'cui': 'C0324815', 'cui_str': 'Mandrillus leucophaeus'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0336993', 'cui_str': 'Tennis racket'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",,0.0269876,"Results and conclusions:  Significant main effects for match revealed higher post-practice overall and forwards distances ( p  < 0.05), peak ( p  < 0.005) and average ( p  < 0.05) speeds and self-efficacy (SE) ( p  = 0.001) were attained.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sindall', 'Affiliation': 'School of Health and Society, The University of Salford, Salford, UK.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Lenton', 'Affiliation': 'The Peter Harrison Centre for Disability Sport, School of Sport Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Barry S', 'Initials': 'BS', 'LastName': 'Mason', 'Affiliation': 'The Peter Harrison Centre for Disability Sport, School of Sport Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Tolfrey', 'Affiliation': 'The Peter Harrison Centre for Disability Sport, School of Sport Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Rory A', 'Initials': 'RA', 'LastName': 'Cooper', 'Affiliation': 'Human Engineering Research Laboratories, Department of Veterans Affairs, Rehabilitation Research and Development Service, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Martin Ginis', 'Affiliation': 'School of Health and Exercise Sciences, The University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Goosey-Tolfrey', 'Affiliation': 'The Peter Harrison Centre for Disability Sport, School of Sport Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}]",Disability and rehabilitation. Assistive technology,['10.1080/17483107.2020.1761892']
1541,31570519,The McCAVE Trial: Vanucizumab plus mFOLFOX-6 Versus Bevacizumab plus mFOLFOX-6 in Patients with Previously Untreated Metastatic Colorectal Carcinoma (mCRC).,"BACKGROUND


Bevacizumab, a VEGF-A inhibitor, in combination with chemotherapy, has proven to increase progression-free survival (PFS) and overall survival in multiple lines of therapy of metastatic colorectal cancer (mCRC). The angiogenic factor angiopoetin-2 (Ang-2) is associated with poor prognosis in many cancers, including mCRC. Preclinical models demonstrate improved activity when inhibiting both VEGF-A and Ang-2, suggesting that the dual VEGF-A and Ang-2 blocker vanucizumab (RO5520985 or RG-7221) may improve clinical outcomes. This phase II trial evaluated the efficacy of vanucizumab plus modified (m)FOLFOX-6 (folinic acid (leucovorin), fluorouracil (5-FU) and oxaliplatin) versus bevacizumab/mFOLFOX-6 for first-line mCRC.
PATIENTS AND METHODS


All patients received mFOLFOX-6 and were randomized 1:1 to also receive vanucizumab 2,000 mg or bevacizumab 5 mg/kg every other week. Oxaliplatin was given for eight cycles; other agents were continued until disease progression or unacceptable toxicity for a maximum of 24 months. The primary endpoint was investigator-assessed PFS.
RESULTS


One hundred eighty-nine patients were randomized (vanucizumab,  n  = 94; bevacizumab,  n  = 95). The number of PFS events was comparable (vanucizumab,  n =  39; bevacizumab,  n  = 43). The hazard ratio was 1.00 (95% confidence interval, 0.64-1.58;  p  = .98) in a stratified analysis based on number of metastatic sites and region. Objective response rate was 52.1% and 57.9% in the vanucizumab and bevacizumab arm, respectively. Baseline plasma Ang-2 levels were prognostic in both arms but not predictive for treatment effects on PFS of vanucizumab. The incidence of adverse events of grade ≥3 was similar between treatment arms (83.9% vs. 82.1%); gastrointestinal perforations (10.8% vs. 8.4%) exceeded previously reported rates in this setting. Hypertension and peripheral edema were more frequent in the vanucizumab arm.
CONCLUSION


Vanucizumab/mFOLFOX-6 did not improve PFS and was associated with increased rates of antiangiogenic toxicity compared with bevacizumab/mFOLFOX-6. Our results suggest that Ang-2 is not a relevant therapeutic target in first-line mCRC.
IMPLICATIONS FOR PRACTICE


This randomized phase II study demonstrates that additional angiopoietin-2 (Ang-2) inhibition does not result in superior benefit over anti-VEGF-A blockade alone when each added to standard chemotherapy. Moreover, the performed pharmacokinetic and pharmacodynamic analysis revealed that vanucizumab was bioavailable and affected its intended target, thereby strongly suggesting that Ang-2 is not a relevant therapeutic target in the clinical setting of treatment-naïve metastatic colorectal cancer. As a result, the further clinical development of the dual VEGF-A and Ang-2 inhibitor vanucizumab was discontinued.",2019,Baseline plasma Ang-2 levels were prognostic in both arms but not predictive for treatment effects on PFS of vanucizumab.,"['Patients with Previously Untreated Metastatic Colorectal Carcinoma (mCRC', 'One hundred eighty-nine patients', 'All patients received mFOLFOX-6']","['Vanucizumab plus mFOLFOX-6', 'Bevacizumab', 'Bevacizumab plus mFOLFOX-6', 'Oxaliplatin', 'bevacizumab', 'vanucizumab and bevacizumab', 'vanucizumab plus modified (m)FOLFOX-6 (folinic acid (leucovorin), fluorouracil (5-FU) and oxaliplatin', 'bevacizumab/mFOLFOX-6', 'vanucizumab 2,000 mg or bevacizumab']","['progression-free survival (PFS) and overall survival', 'investigator-assessed PFS', 'incidence of adverse events of grade ≥3', 'gastrointestinal perforations', 'Objective response rate', 'PFS', 'Hypertension and peripheral edema', 'hazard ratio', 'rates of antiangiogenic toxicity', 'number of PFS events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0009402', 'cui_str': 'Colorectal Carcinoma'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C4331496', 'cui_str': 'vanucizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1963976', 'cui_str': 'Gastrointestinal perforation (SMQ)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema (morphologic abnormality)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",189.0,0.110282,Baseline plasma Ang-2 levels were prognostic in both arms but not predictive for treatment effects on PFS of vanucizumab.,"[{'ForeName': 'Johanna C', 'Initials': 'JC', 'LastName': 'Bendell', 'Affiliation': 'Sarah Cannon Research Institute and Tennessee Oncology, Nashville, Tennessee, USA jbendell@tnonc.com.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Sauri', 'Affiliation': ""Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Antonio Cubillo', 'Initials': 'AC', 'LastName': 'Gracián', 'Affiliation': 'Centro Integral Oncológico Clara Campal, Hospital Madrid Norte Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Alvarez', 'Affiliation': 'Centro Integral Oncológico Clara Campal, Hospital Madrid Norte Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'López-López', 'Affiliation': 'Marqués de Valdecilla University Hospital, Santander, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'García-Alfonso', 'Affiliation': 'Hospital Universitario Gregorio Maranon, Madrid, Spain.'}, {'ForeName': 'Maen', 'Initials': 'M', 'LastName': 'Hussein', 'Affiliation': 'Florida Cancer Specialists, Leesburg, Florida, USA.'}, {'ForeName': 'Maria-Luisa Limon', 'Initials': 'ML', 'LastName': 'Miron', 'Affiliation': 'Hospital Universitario Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Cervantes', 'Affiliation': 'Department of Medical Oncology, Biomedical Research Institute, INCLIVA, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Montagut', 'Affiliation': 'Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Cristina Santos', 'Initials': 'CS', 'LastName': 'Vivas', 'Affiliation': ""Institut Català d'Oncologia and L'Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bessudo', 'Affiliation': 'California Cancer Associates for Research and Excellence, San Diego, California, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Plezia', 'Affiliation': 'Arizona Clinical Research Center, Tucson, Arizona, USA.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Moons', 'Affiliation': 'Imelda General Hospital, Bonheiden, Belgium.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Andel', 'Affiliation': 'County Hospital Steyr, Steyr, Austria.'}, {'ForeName': 'Jaafar', 'Initials': 'J', 'LastName': 'Bennouna', 'Affiliation': ""Institut de Cancerologie de l'Ouest, Saint Herblain, France.""}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'van der Westhuizen', 'Affiliation': 'Calvary Mater Hospital, Newcastle, Australia.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Samuel', 'Affiliation': 'Aberdeen Royal Infirmary, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Rossomanno', 'Affiliation': 'Roche Innovation Center Basel, Basel, Switzerland.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Boetsch', 'Affiliation': 'Roche Innovation Center Basel, Basel, Switzerland.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Lahr', 'Affiliation': 'Roche Innovation Center Munich, Penzberg, Germany.'}, {'ForeName': 'Izolda', 'Initials': 'I', 'LastName': 'Franjkovic', 'Affiliation': 'Roche Innovation Center Munich, Penzberg, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Heil', 'Affiliation': 'Roche Innovation Center Munich, Penzberg, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Lechner', 'Affiliation': 'Roche Innovation Center Munich, Penzberg, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Krieter', 'Affiliation': 'Roche Innovation Center Munich, Penzberg, Germany.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Hurwitz', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The oncologist,['10.1634/theoncologist.2019-0291']
1542,31473167,Safety and pharmacokinetics of broadly neutralising human monoclonal antibody VRC07-523LS in healthy adults: a phase 1 dose-escalation clinical trial.,"BACKGROUND


Human monoclonal antibodies that potently and broadly neutralise HIV-1 are under development to prevent and treat HIV-1 infection. In this phase 1 clinical trial we aimed to determine the safety, tolerability, and pharmacokinetic profile of the broadly neutralising monoclonal antibody VRC07-523LS, an engineered variant of VRC01 that targets the CD4 binding site of the HIV-1 envelope protein.
METHODS


This phase 1, open-label, dose-escalation clinical trial was done at the National Institutes of Health Clinical Center in Bethesda, MD, USA. Individuals were recruited from the greater Washington, DC, area by IRB-approved written and electronic media. We enrolled healthy, HIV-1-negative adults aged 18-50 years. Inclusion criteria were good general health, measured through clinical laboratory tests, medical history, and physical examination. Participants self-selected into one of seven open groups during enrolment without randomisation. Four groups received a single intravenous dose of 1, 5, 20, or 40 mg/kg of VRC07-523LS, and one group received a single 5 mg/kg subcutaneous dose. Two groups received three doses of either 20 mg/kg intravenous VRC07-523LS, or 5 mg/kg subcutaneous VRC07-523LS at 12-week intervals. The primary outcome was the safety and tolerability of VRC07-523LS, assessed by dose, route, and number of administrations. This study is registered with ClinicalTrials.gov, NCT03015181.
FINDINGS


Between Feb 21, 2017, and September 13, 2017, we enrolled 26 participants, including 11 (42%) men and 15 (58%) women. Two (8%) participants withdrew from the study early: one participant in group 1 enrolled in the study but never received VRC07-523LS, and one participant in group 6 chose to withdraw after a single administration. One (4%) participant in group 7 received only one of the three scheduled administrations. 17 participants received intravenous administrations and 8 participants received subcutaneous administrations. VRC07-523LS was safe and well tolerated, we observed no serious adverse events or dose-limiting toxic effects. All reported local and systemic reactogenicity was mild to moderate in severity. The most commonly reported symptoms following intravenous administration were malaise or myalgia in three (18%) participants and headache or chills in two (12%) participants. The most commonly reported symptoms following subcutaneous administration were pain and tenderness in four participants (50%) and malaise or headache in three (38%) participants.
INTERPRETATION


Safe and well tolerated, VRC07-523LS is a strong and practical candidate for inclusion in HIV-1 prevention and therapeutic strategies. The results from this trial also indicate that an HIV-1 broadly neutralising monoclonal antibody engineered for improved pharmacokinetic and neutralisation properties can be safe for clinical use.
FUNDING


National Institutes of Health.",2019,"VRC07-523LS was safe and well tolerated, we observed no serious adverse events or dose-limiting toxic effects.","['Between Feb 21, 2017, and September 13, 2017', 'enrolled healthy, HIV-1-negative adults aged 18-50 years', 'Participants self-selected into one of seven open groups during enrolment without randomisation', 'enrolled 26 participants, including 11 (42%) men and 15 (58%) women', 'healthy adults', '17 participants']","['20 mg/kg intravenous VRC07-523LS, or 5 mg/kg subcutaneous VRC07-523LS', 'neutralising human monoclonal antibody VRC07-523LS', 'VRC07-523LS']","['local and systemic reactogenicity', 'safety and tolerability of VRC07-523LS, assessed by dose, route, and number of administrations', 'malaise or headache', 'malaise or myalgia', 'safe and well tolerated', 'headache or chills', 'pain and tenderness', 'safety, tolerability, and pharmacokinetic profile']","[{'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0231218', 'cui_str': 'Undifferentiated illness: Vague ill health'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0085593', 'cui_str': 'Chills'}, {'cui': 'C0234242', 'cui_str': 'Pain and tenderness (finding)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",26.0,0.269949,"VRC07-523LS was safe and well tolerated, we observed no serious adverse events or dose-limiting toxic effects.","[{'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Gaudinski', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Katherine V', 'Initials': 'KV', 'LastName': 'Houser', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Doria-Rose', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Grace L', 'Initials': 'GL', 'LastName': 'Chen', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ro Shauna S', 'Initials': 'RSS', 'LastName': 'Rothwell', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Berkowitz', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Costner', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'LaSonji A', 'Initials': 'LA', 'LastName': 'Holman', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ingelise J', 'Initials': 'IJ', 'LastName': 'Gordon', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Cynthia S', 'Initials': 'CS', 'LastName': 'Hendel', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Kaltovich', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Conan-Cibotti', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Gomez Lorenzo', 'Affiliation': 'Vaccine Clinical Research Branch, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Carter', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Sitar', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Carlton', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Gall', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Laurencot', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bob C', 'Initials': 'BC', 'LastName': 'Lin', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Bailer', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Adrian B', 'Initials': 'AB', 'LastName': 'McDermott', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sung-Youl', 'Initials': 'SY', 'LastName': 'Ko', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Amarendra', 'Initials': 'A', 'LastName': 'Pegu', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Young D', 'Initials': 'YD', 'LastName': 'Kwon', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Kwong', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Aryan M', 'Initials': 'AM', 'LastName': 'Namboodiri', 'Affiliation': 'Department of Microbiology and Immunology, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Janardan P', 'Initials': 'JP', 'LastName': 'Pandey', 'Affiliation': 'Department of Microbiology and Immunology, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Schwartz', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Arnold', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Zonghui', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Biostatistics Research Branch, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Yunda', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Koup', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'School of Medicine, University of California San Diego, San Diego, CA, USA; Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Barney S', 'Initials': 'BS', 'LastName': 'Graham', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Mascola', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Ledgerwood', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. Electronic address: ledgerwood@mail.nih.gov.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(19)30181-X']
1543,27222525,Insulin Resistance Intervention After Stroke Trial of Pioglitazone: Is This Perhaps the End of the Beginning?,,2016,,[],"['Pioglitazone', 'Insulin Resistance Intervention']",[],[],"[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}]",[],,0.09727,,"[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Ntaios', 'Affiliation': 'From the Department of Medicine, University of Thessaly, Larissa, Greece (G.N.); Stroke Outcomes Laboratory, Department of Neurology, Baylor College of Medicine, Houston, TX (T.A.K.); and Center for Translational Research on Inflammatory Diseases, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX (T.A.K.). gntaios@med.uth.gr.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Kent', 'Affiliation': 'From the Department of Medicine, University of Thessaly, Larissa, Greece (G.N.); Stroke Outcomes Laboratory, Department of Neurology, Baylor College of Medicine, Houston, TX (T.A.K.); and Center for Translational Research on Inflammatory Diseases, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX (T.A.K.).'}]",Stroke,['10.1161/STROKEAHA.116.013230']
1544,31752969,Delivery of home-based postpartum contraception in rural Guatemalan women: a cluster-randomized trial protocol.,"BACKGROUND


Postpartum contraception is important to prevent unintended and closely spaced pregnancies following childbirth.
METHODS


This study is a cluster-randomized trial of communities in rural Guatemala where women receive ante- and postnatal care through a community-based nursing program. When nurses visit women for their postpartum visit in the intervention clusters, instead of providing only routine care that includes postpartum contraceptive education and counseling, the nurses will also bring a range of barrier, short-acting, and long-acting contraceptives that will be offered and administered in the home setting, after routine clinical care is provided.
DISCUSSION


A barrier to postpartum contraception is access to medications and devices. Our study removes some access barriers (distance, time, cost) by providing contraception in the home. We also trained community nurses to place implants, which are a type of long-acting reversible contraceptive method that was previously only available in the closest town which is about an hour away by vehicular travel. Therefore, our study examines how home-based delivery of routinely available contraceptives and the less routinely available implant may be associated with increased uptake of postpartum contraception within 3 months of childbirth. The potential implications of this study include that nurses may be able to be trained to safely provide contraceptives, including placing implants, in the home setting, and provision of home-based contraception may be an effective way of delivering an evidence-based intervention for preventing unintended and closely spaced pregnancies in the postpartum period.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT04005391. Retrospectively registered on 1 July 2019.",2019,"When nurses visit women for their postpartum visit in the intervention clusters, instead of providing only routine care that includes postpartum contraceptive education and counseling, the nurses will also bring a range of barrier, short-acting, and long-acting contraceptives that will be offered and administered in the home setting, after routine clinical care is provided.
","['communities in rural Guatemala where women receive ante- and postnatal care through a community-based nursing program', 'rural Guatemalan women']",['home-based postpartum contraception'],[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0032782', 'cui_str': 'Postpartum Care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}]",[],,0.184952,"When nurses visit women for their postpartum visit in the intervention clusters, instead of providing only routine care that includes postpartum contraceptive education and counseling, the nurses will also bring a range of barrier, short-acting, and long-acting contraceptives that will be offered and administered in the home setting, after routine clinical care is provided.
","[{'ForeName': 'Margo S', 'Initials': 'MS', 'LastName': 'Harrison', 'Affiliation': 'University of Colorado, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, Denver, CO, 80045, USA. margo.harrison@ucdenver.edu.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Bunge-Montes', 'Affiliation': 'Fundación para la Salud Integral de los Guatemaltecos (FSIG), Quetzaltenango, Guatemala.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Rivera', 'Affiliation': 'Fundación para la Salud Integral de los Guatemaltecos (FSIG), Quetzaltenango, Guatemala.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Jimenez-Zambrano', 'Affiliation': 'University of Colorado, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, Denver, CO, 80045, USA.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Heinrichs', 'Affiliation': 'Denver Health, Denver, CO, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Scarbro', 'Affiliation': 'University of Colorado, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, Denver, CO, 80045, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Juarez-Colunga', 'Affiliation': 'University of Colorado, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, Denver, CO, 80045, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bolanos', 'Affiliation': 'Fundación para la Salud Integral de los Guatemaltecos (FSIG), Quetzaltenango, Guatemala.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Asturias', 'Affiliation': 'University of Colorado, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, Denver, CO, 80045, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Berman', 'Affiliation': 'University of Colorado, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, Denver, CO, 80045, USA.'}, {'ForeName': 'Jeanelle', 'Initials': 'J', 'LastName': 'Sheeder', 'Affiliation': 'University of Colorado, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, Denver, CO, 80045, USA.'}]",Trials,['10.1186/s13063-019-3735-3']
1545,32412858,Predicting factors associated with hypoglycemia reduction with automated predictive insulin suspension in patients at high risk of severe hypoglycemia: an analysis from the SMILE randomized trial.,"BACKGROUND


This analysis from the SMILE randomized study was performed to identify predictive factors associated with the greatest reductions in hypoglycemia with the Medtronic MiniMed™ 640G Suspend before low feature in adults with type 1 diabetes at high risk of severe hypoglycemia.
METHODS


Clinical and treatment-related factors associated with decreased sensor hypoglycemia (SH) were identified in participants from the intervention arm by univariate and multivariate analyses.
RESULTS


The reduction in SH events <54mg/dL (<3.0 mmol/L) in the intervention group was significantly (p<0.0001) associated with the baseline mean number of sensor hypoglycemic events (MNSHE) <54mg/dL. When excluding CGM factors not readily available (MNSHE, duration of SH events, area under the curve [AUC], mean amplitude of glycemic excursions [MAGE]), only the baseline mean time spent <54mg/dL was found to be a significant independent predictor factor (p0.0001). Baseline HbA1c, mean self-monitoring of blood glucose (SMBG) and coefficient of variation (CV) of SMBG were significant, albeit weak, predictors in the absence of any CGM data.
CONCLUSIONS


The greatest reductions in SH events achieved with the MiniMed 640G system with the Suspend before low feature were seen in participants with higher baseline MNSHE. Measuring these (usually uncollected) events can be a useful tool to predict hypoglycemia reduction.",2020,"The reduction in SH events <54mg/dL (<3.0 mmol/L) in the intervention group was significantly (p<0.0001) associated with the baseline mean number of sensor hypoglycemic events (MNSHE) <54mg/dL. When excluding CGM factors not readily available (MNSHE, duration of SH events, area under the curve [AUC], mean amplitude of glycemic excursions [MAGE]), only the baseline mean time spent <54mg/dL was found to be a significant independent predictor factor (p0.0001).","['adults with type 1 diabetes at high risk of severe hypoglycemia', 'patients at high risk of severe hypoglycemia']",['automated predictive insulin suspension'],"['CGM factors not readily available (MNSHE, duration of SH events, area under the curve [AUC], mean amplitude of glycemic excursions [MAGE', 'sensor hypoglycemia (SH', 'sensor hypoglycemic events (MNSHE', 'reduction in SH events', 'Baseline HbA1c, mean self-monitoring of blood glucose (SMBG) and coefficient of variation (CV) of SMBG', 'SH events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]","[{'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]",,0.0353609,"The reduction in SH events <54mg/dL (<3.0 mmol/L) in the intervention group was significantly (p<0.0001) associated with the baseline mean number of sensor hypoglycemic events (MNSHE) <54mg/dL. When excluding CGM factors not readily available (MNSHE, duration of SH events, area under the curve [AUC], mean amplitude of glycemic excursions [MAGE]), only the baseline mean time spent <54mg/dL was found to be a significant independent predictor factor (p0.0001).","[{'ForeName': 'Aklilu', 'Initials': 'A', 'LastName': 'Habteab', 'Affiliation': 'Medtronic Bakken Research Center, Maastricht, Netherlands; aklilu.habteab@medtronic.com.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Castañeda', 'Affiliation': 'Medtronic Bakken Research Center, Maastricht, Netherlands; javier.castaneda@medtronic.com.'}, {'ForeName': 'Harold W', 'Initials': 'HW', 'LastName': 'de Valk', 'Affiliation': 'University Medical Centre Utrecht, Department of Internal Medicine1, F02.126, Heidelberglaan 100, Utrecht, Utrecht, Netherlands, 3584 CX; h.w.devalk@umcutrecht.nl.'}, {'ForeName': 'Pratik', 'Initials': 'P', 'LastName': 'Choudhary', 'Affiliation': ""King's College London, Diabetes, King's College Hospital, Denmark Hill, London, London, United Kingdom of Great Britain and Northern Ireland, SE5 9NU; pratik.choudhary@kcl.ac.uk.""}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Bosi', 'Affiliation': 'IRCC San Raffaele Hospital and San Raffaele Vita Salute University , Diabetes Research Institute , Milano, Italy; bosi.emanuele@hsr.it.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Lablanche', 'Affiliation': ""Grenoble University Hospital, Clinique d'Endocrinologie Diabétologie Nutrition , Grenoble, France; SLablanche@chu-grenoble.fr.""}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'de Portu', 'Affiliation': 'Medtronic International Trading S?rl, Rte du Molliau 31, Tolochenaz, Switzerland, 1131; simona.de.portu@medtronic.com.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Da Silva', 'Affiliation': 'Medtronic International Trading Sàrl, Diabetes, route du Molliau 31, Tolochenaz, Switzerland, 1131; julien.da.silva@medtronic.com.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Vorrink', 'Affiliation': 'Medtronic International Trading, Tolochenaz, Switzerland; linda.vorrink@medtronic.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'Medtronic Diabetes, Clinical Research, Northridge, California, United States; john.shin@medtronic.com.'}, {'ForeName': 'Ohad', 'Initials': 'O', 'LastName': 'Cohen', 'Affiliation': 'Medtronic International Trading Sàrl, Toluchenaz, Tolochenaz, Switzerland, 46733; ohad.cohen@medtronic.com.'}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0495']
1546,32412860,Effects of a Single Power Strength Training Session on Heart Rate Variability When Performed at Different Simulated Altitudes.,"Background:  This study assessed heart rate variability (HRV) after a single power strength training session performed at different hypoxic levels.  Materials and Methods:  Eight physically active subjects (31.1 ± 4.3 years; 177.6 ± 3.0 cm; 70.1 ± 5.2 kg) performed 6 bouts of 15-second continuous maximal jump exercises interspersed by 3 minutes of rest at different altitude levels (total volume of each session: 20 minutes). The normoxic hypoxia levels were FiO 2  low altitude: 20.9%; moderate altitude: 16.5%; and high altitude: 13.5%.  Results:  Average power output during the jumps was similar for all conditions (≅3150 W). Twenty-four hours before (PRE) and 24 hours after (POST) each training session, HRV parameters (R-R, square root of the mean of the sum of differences between intervals [RMSSD], pNN50, and very low frequency, low frequency, and high frequency) were determined without resulting in significant statistical differences, neither from PRE to POST nor between conditions ( p  > 0.05).  Conclusions:  This study showed a negligible perturbation of HRV parameters 24 hours after a single power strength session up to a hypoxic level equivalent to 4000 m. Further studies are needed to determine the hypoxia-dependent threshold and intensities of training loads affecting HRV.",2020,"Twenty-four hours before (PRE) and 24 hours after (POST) each training session, HRV parameters (R-R, square root of the mean of the sum of differences between intervals [RMSSD], pNN50, and very low frequency, low frequency, and high frequency) were determined without resulting in significant statistical differences, neither from PRE to POST nor between conditions ( p  > 0.05).  ",['Eight physically active subjects (31.1\u2009±\u20094.3 years; 177.6\u2009±\u20093.0\u2009cm; 70.1\u2009±\u20095.2\u2009kg) performed'],"['6 bouts of 15-second continuous maximal jump exercises', 'Single Power Strength Training Session']","['heart rate variability (HRV', 'normoxic hypoxia levels', 'Heart Rate Variability']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",8.0,0.014031,"Twenty-four hours before (PRE) and 24 hours after (POST) each training session, HRV parameters (R-R, square root of the mean of the sum of differences between intervals [RMSSD], pNN50, and very low frequency, low frequency, and high frequency) were determined without resulting in significant statistical differences, neither from PRE to POST nor between conditions ( p  > 0.05).  ","[{'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Álvarez-Herms', 'Affiliation': 'Department of Cell Biology, Physiology and Immunology, Faculty of Biology, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Julià-Sánchez', 'Affiliation': 'Department of Cell Biology, Physiology and Immunology, Faculty of Biology, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Hannes', 'Initials': 'H', 'LastName': 'Gatterer', 'Affiliation': 'Institute for Mountain Emergency Medicine, Bolzano, Italy.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Corbi', 'Affiliation': 'National Institute of Physical Education of Catalonia, University of Lleida, Lleida, Spain.'}, {'ForeName': 'Gines', 'Initials': 'G', 'LastName': 'Viscor', 'Affiliation': 'Department of Cell Biology, Physiology and Immunology, Faculty of Biology, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Burtscher', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Innsbruck, Austria.'}]",High altitude medicine & biology,['10.1089/ham.2020.0014']
1547,32412872,"Investigation of the effects of veterinarians' attire on ratings of trust, confidence, and comfort in a sample of pet owners in Canada.","OBJECTIVE


To examine companion animal owners' perceptions of appropriate veterinarian attire and investigate potential associations between a veterinarian's attire and clients' ratings of trust in, confidence in, and comfort with a veterinarian.
SAMPLE


449 pet owners.
PROCEDURES


Participants were randomly assigned to complete a questionnaire containing photos of a male or female model veterinarian photographed in 8 attire types (formal attire, white dress shirt with black pants, white casual shirt with khaki pants, surgical scrubs, white casual shirt with jeans, surgical scrub top with jeans, surgical scrub top with khaki pants, and white laboratory coat with khaki pants). Participants were asked to rate their trust in, confidence in, and comfort with the pictured individual on a response scale of 1 (low) to 7 (high), rank photos according to their preferences for attire, and provide input on the importance of attire and other appearance-related subjects. Attire and gender of photographed individual and participant demographics were investigated for associations with trust, confidence, and comfort scores.
RESULTS


Most (317/445 [71%]) respondents indicated veterinarians' attire was important. Attire type was significantly associated with respondents' trust, confidence, and comfort scores. Model veterinarian gender and participant education level were also associated with trust and comfort scores.
CONCLUSIONS AND CLINICAL RELEVANCE


Veterinarians' attire is a form of nonverbal communication that is likely to inform clients' first impressions and may influence clients' trust in, confidence in, and comfort with a veterinarian. Veterinary personnel and veterinary management should consider how attire and general appearance represent staff members or their practice.",2020,"Attire type was significantly associated with respondents' trust, confidence, and comfort scores.","['SAMPLE\n\n\n449 pet owners', 'sample of pet owners in Canada', 'Participants']","[""veterinarians' attire"", 'questionnaire containing photos of a male or female model veterinarian photographed in 8 attire types (formal attire, white dress shirt with black pants, white casual shirt with khaki pants, surgical scrubs, white casual shirt with jeans, surgical scrub top with jeans, surgical scrub top with khaki pants, and white laboratory coat with khaki pants']","['ratings of trust, confidence, and comfort']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0242856', 'cui_str': 'Veterinarian'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0453917', 'cui_str': 'Shirt'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0425488', 'cui_str': 'Rapid shallow breathing'}, {'cui': 'C2936698', 'cui_str': 'Scrubbing, Surgical'}, {'cui': 'C0453932', 'cui_str': 'Jeans'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0453946', 'cui_str': 'Coat'}]","[{'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.0405637,"Attire type was significantly associated with respondents' trust, confidence, and comfort scores.","[{'ForeName': 'Jason B', 'Initials': 'JB', 'LastName': 'Coe', 'Affiliation': ''}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': ""O'Connor"", 'Affiliation': ''}, {'ForeName': 'Christina N', 'Initials': 'CN', 'LastName': 'Pizzolon', 'Affiliation': ''}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Hester', 'Affiliation': ''}, {'ForeName': 'Leandra J', 'Initials': 'LJ', 'LastName': 'Nogueira Borden', 'Affiliation': ''}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Haley', 'Affiliation': ''}]",Journal of the American Veterinary Medical Association,['10.2460/javma.256.11.1268']
1548,28193490,Physical activity and academic achievement across the curriculum: Results from a 3-year cluster-randomized trial.,"We compared changes in academic achievement across 3years between children in elementary schools receiving the Academic Achievement and Physical Activity Across the Curriculum intervention (A+PAAC), in which classroom teachers were trained to deliver academic lessons using moderate-to-vigorous physical activity (MVPA) compared to a non-intervention control. Elementary schools in eastern Kansas (n=17) were cluster randomized to A+PAAC (N=9, target ≥100min/week) or control (N=8). Academic achievement (math, reading, spelling) was assessed using the Wechsler Individual Achievement Test-Third Edition (WIAT-III) in a sample of children (A+PAAC=316, Control=268) in grades 2 and 3 at baseline (Fall 2011) and repeated each spring across 3years. On average 55min/week of A+PACC lessons were delivered each week across the intervention. Baseline WIAT-III scores (math, reading, spelling) were significantly higher in students in A+PAAC compared with control schools and improved in both groups across 3years. However, linear mixed modeling, accounting for baseline between group differences in WIAT-III scores, ethnicity, family income, and cardiovascular fitness, found no significant impact of A+PAAC on any of the academic achievement outcomes as determined by non-significant group by time interactions. A+PAAC neither diminished or improved academic achievement across 3-years in elementary school children compared with controls. Our target of 100min/week of active lessons was not achieved; however, students attending A+PAAC schools received an additional 55min/week of MVPA which may be associated with both physical and mental health benefits, without a reduction in time devoted to academic instruction.",2017,"Baseline WIAT-III scores (math, reading, spelling) were significantly higher in students in A+PAAC compared with control schools and improved in both groups across 3years.","['students attending A+PAAC schools', 'Elementary schools in eastern Kansas (n=17']","['A+PAAC', 'classroom teachers were trained to deliver academic lessons using moderate-to-vigorous physical activity (MVPA']","['Baseline WIAT-III scores (math, reading, spelling', 'WIAT-III scores, ethnicity, family income, and cardiovascular fitness', 'Academic achievement (math, reading, spelling', 'Physical activity and academic achievement', 'academic achievement']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0013658', 'cui_str': 'Educational Achievement'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0183944,"Baseline WIAT-III scores (math, reading, spelling) were significantly higher in students in A+PAAC compared with control schools and improved in both groups across 3years.","[{'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Internal Medicine, Cardiovascular Research Institute, Center for Physical Activity and Weight Management, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: jdonnelly@ku.edu.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Hillman', 'Affiliation': 'Department of Psychology, Department of Health Sciences, Northeastern University, 125 NI, 360 Huntington Avenue, Boston, MA 02115, USA.'}, {'ForeName': 'Jerry L', 'Initials': 'JL', 'LastName': 'Greene', 'Affiliation': 'Department of Health, Sport, and Exercise Science, The University of Kansas, 1301 West Campus Road, Lawrence, KS, 66045, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Hansen', 'Affiliation': 'Department of Psychology and Research in Education, The University of Kansas, 1122 West Campus Road, Lawrence, KS 66045, USA.'}, {'ForeName': 'Cheryl A', 'Initials': 'CA', 'LastName': 'Gibson', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA.'}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Sullivan', 'Affiliation': 'Department of Dietetics and Nutrition, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Poggio', 'Affiliation': 'Department of Psychology and Research in Education, The University of Kansas, 1122 West Campus Road, Lawrence, KS 66045, USA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Mayo', 'Affiliation': 'Department of Biostatistics, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Lambourne', 'Affiliation': 'Department of Internal Medicine, Cardiovascular Research Institute, Center for Physical Activity and Weight Management, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA.'}, {'ForeName': 'Amanda N', 'Initials': 'AN', 'LastName': 'Szabo-Reed', 'Affiliation': 'Department of Internal Medicine, Cardiovascular Research Institute, Center for Physical Activity and Weight Management, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: aszabo2@ku.edu.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Herrmann', 'Affiliation': 'Department of Internal Medicine, Cardiovascular Research Institute, Center for Physical Activity and Weight Management, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA.'}, {'ForeName': 'Jeffery J', 'Initials': 'JJ', 'LastName': 'Honas', 'Affiliation': 'Department of Internal Medicine, Cardiovascular Research Institute, Center for Physical Activity and Weight Management, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Scudder', 'Affiliation': 'Department of Kinesiology and Community Health, The University of Illinois Urbana-Champaign, 906 South Goodwin, Urbana, Il 61801, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Betts', 'Affiliation': 'Department of Internal Medicine, Cardiovascular Research Institute, Center for Physical Activity and Weight Management, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Henley', 'Affiliation': 'Department of Internal Medicine, Cardiovascular Research Institute, Center for Physical Activity and Weight Management, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA.'}, {'ForeName': 'Suzanne L', 'Initials': 'SL', 'LastName': 'Hunt', 'Affiliation': 'Department of Biostatistics, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Washburn', 'Affiliation': 'Department of Internal Medicine, Cardiovascular Research Institute, Center for Physical Activity and Weight Management, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA.'}]",Preventive medicine,['10.1016/j.ypmed.2017.02.006']
1549,30690854,Predictors of mortality in patients with non-anterior ST-segment elevation myocardial infarction: Analysis from the HORIZONS-AMI trial.,"OBJECTIVES


We sought to identify clinical, electrocardiographic (ECG), and angiographic characteristics that are predictive of 3-year mortality after primary percutaneous coronary intervention (PCI) in patients with non-anterior ST-elevation myocardial infarction (NA-STEMI) from the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial.
BACKGROUND


Which patients with NA-STEMI undergoing PCI have a poor prognosis is uncertain.
METHODS


NA-STEMI was defined as ST-segment elevation in lateral (V5, V6, I, aVL), inferior (II, III, aVF), or inferolateral (I, II, III, aVF, and V5-V6) ECG leads or posterior myocardial infarction with ST-segment depression of ≥1 mm in ≥2 contiguous anterior leads. Cox regression was used to identify independent predictors of 3-year mortality. Missing data were imputed using multiple imputation.
RESULTS


In HORIZONS-AMI, 2,578/3,602 patients had no prior coronary artery bypass grafting, underwent single-vessel PCI, and had baseline ECG data assessed in an independent core laboratory. Among them, 1,495 (58.0%) had NA-STEMI. Patients with NA-STEMI had lower 3-year mortality risk than those with anterior STEMI (4.5% versus 7.1%, P = 0.004). The independent predictors of increased 3-year mortality in NA-STEMI were older age (median > 59.0 years), diabetes, reduced LVEF (≤50%), Killip class ≥2, post-procedure TIMI flow 0-2 versus 3, renal insufficiency, and ST-resolution <30% at 60 min post-PCI. Patients with 0, 1, 2, 3, and ≥4 of these risk factors had 3-year mortality rates of 1.8%, 2.3%, 3.1%, 6.1%, and 36.3%, respectively (P < 0.0001).
CONCLUSIONS


Although NA-STEMI carries a better prognosis than anterior STEMI, high-risk patient cohorts with NA-STEMI may be identified who have substantial 3-year mortality.",2019,"Patients with NA-STEMI had lower 3-year mortality risk than those with anterior STEMI (4.5% versus 7.1%, P = 0.004).","['patients with non-anterior ST-segment elevation myocardial infarction', 'patients with non-anterior ST-elevation myocardial infarction (NA-STEMI', 'Acute Myocardial Infarction', '2,578/3,602 patients had no prior coronary artery bypass grafting, underwent single-vessel PCI, and had baseline ECG data assessed in an independent core laboratory']","['primary percutaneous coronary intervention (PCI', 'Revascularization and Stents']","['3-year mortality rates', 'ST-segment elevation in lateral (V5, V6, I, aVL), inferior (II, III, aVF), or inferolateral (I, II, III, aVF, and V5-V6) ECG leads or posterior myocardial infarction with ST-segment depression', '3-year mortality risk', '3-year mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3874460', 'cui_str': 'Anterior ST segment elevation'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation (finding)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0449216', 'cui_str': 'aVL (body structure)'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449215', 'cui_str': 'aVF (body structure)'}, {'cui': 'C0179504', 'cui_str': 'ECG lead'}, {'cui': 'C0340319', 'cui_str': 'Posterior myocardial infarction'}, {'cui': 'C0520887', 'cui_str': 'ST segment depression (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0377035,"Patients with NA-STEMI had lower 3-year mortality risk than those with anterior STEMI (4.5% versus 7.1%, P = 0.004).","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Redfors', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Gersh', 'Affiliation': 'Cardiovascular Division, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'McAndrew', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Mintz', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28096']
1550,28087851,Effect of Educational Intervention on the Fruit and Vegetables Consumption among the Students: Applying Theory of Planned Behavior.,"BACKGROUND


The importance of consuming fruits and vegetables (F&V) in prevention of chronic diseases is known. Childhood play an important role in formation of healthy eating habits. The purpose of this study was to examine the effect of education, with application of the theory of planned behavior, on improvement of F&V consumption.
METHODS


In this quasi-experimental study, 184 fourth, fifth, and sixth-grade students participated were enrolled from Jan 2013 to Jun 2014. The samples were selected from 6 schools in Chalderan County, West Azerbaijan, Iran through cluster random sampling method. Two out of 6 schools were randomly selected and each was employed in either experimental or control group. The data collection instruments included a researcher-made questionnaire and a 24-h F&V recall. Data were collected after verification of the reliability and validity of the questionnaire.
RESULTS


Before the intervention, no significant difference was observed between the intervention and control group regarding attitude, subjective norms, perceived behavioral control, behavioral intention and fruits and vegetables consumption (P>0.05). However, after the educational intervention, the mean scores of attitude, subjective norms, perceived behavioral control, behavioral intention variables and fruits and vegetables were significantly higher in the intervention group when compared to the control group(P<0.05).
CONCLUSIONS


Increased behavioral intention, attitude, subjective norms, and perceived behavioral control can promote F&V consumption among the students.",2016,"Before the intervention, no significant difference was observed between the intervention and control group regarding attitude, subjective norms, perceived behavioral control, behavioral intention and fruits and vegetables consumption (P>0.05).","['184 fourth, fifth, and sixth-grade students participated were enrolled from Jan 2013 to Jun 2014', 'The samples were selected from 6 schools in Chalderan County, West Azerbaijan, Iran through cluster random sampling method', 'Students', 'healthy eating habits']","['Educational Intervention', 'consuming fruits and vegetables (F&V']","['mean scores of attitude, subjective norms, perceived behavioral control, behavioral intention variables and fruits and vegetables', 'Fruit and Vegetables Consumption', 'attitude, subjective norms, perceived behavioral control, behavioral intention and fruits and vegetables consumption']","[{'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0205440', 'cui_str': 'Sixth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0004486', 'cui_str': 'Azerbaijan SSR'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",6.0,0.0118992,"Before the intervention, no significant difference was observed between the intervention and control group regarding attitude, subjective norms, perceived behavioral control, behavioral intention and fruits and vegetables consumption (P>0.05).","[{'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Taghdisi', 'Affiliation': 'Community-Based Participatory Research Center, Iranian Institute for Reduction of High-Risk Behaviors, Tehran, Iran.'}, {'ForeName': 'Towhid', 'Initials': 'T', 'LastName': 'Babazadeh', 'Affiliation': 'Department of Health Education and Promotion, Student Research Committee, School of Health, Tabriz University of Medical Sciences, Tabriz, Iran. towhid.babazadeh70@gmail.com.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Moradi', 'Affiliation': 'Department of Municipal Health in Tehran, Tehran Municipality, Tehran, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Shariat', 'Affiliation': 'Department of Municipal Health in Tehran, Tehran Municipality, Tehran, Iran.'}]",Journal of research in health sciences,[]
1551,32412916,Binaural Beats Reduce Postoperative Morphine Consumption in Older adults After Total Knee Replacement Surgery.,"Context


A reduction in the use of opioids by older adult patients could reduce unpleasant side effects for them. During general anesthesia, binaural beat (BB) listening has been found to reduce intraoperative fentanyl consumption as well as postoperative pain scores and discharge time. Auditory BBs are a perceptual phenomenon occurring when tones of 2 slightly different frequencies are presented simultaneously and separately to each ear.
Objective


The study intended to evaluate the ability of BBs, as a nonpharmacological premedication, to reduce postoperative morphine consumption in older adults undergoing total knee replacement surgery and to modify the levels of anxiety and feelings of pain that patients experience.
Design


The research team designed a prospective, single-center, randomized controlled study.
Setting


The study was conducted in the Orthopedic Department of the Santa Maria Maddalena Hospital (Volterra [Pisa], Italy).
Participants


Forty older adults at the hospital who were undergoing total knee joint replacement with spinal anesthesia participated in the study.
Intervention


The study included 2 groups (n = 20 each), one receiving BBs stimulation with frequencies of 256 Hz in one ear and 260 Hz in the opposite ear producing a BB of 4 Hz (intervention group), and the other receiving acoustical stimulation at 256 Hz in both ears (control group). BBs, or acoustical stimulation, were administered before the surgical procedure. Both acoustical stimuli, generated with the Gnaural program, were delivered through stereo headphones connected to a laptop in the preoperative holding area.
Outcome Measures


The study measured postoperative, cumulative, self-administered morphine consumption, in mg, through a patient-controlled analgesia device. Feelings of anxiety were also assessed using the State-Trait Anxiety Inventory, and feelings of pain were measured every 8 h during the first postoperative day using a numerical rating scale.
Results


Patients who received the intervention, consumed almost half of the dosage of morphine during the first postoperative day when compared with the control group's consumption, 5.75 mg ± 5.25 vs 11.85 mg ± 7.71, respectively. The consumption did not correlate to anxiety measures. Regarding pain perception, no differences between the groups were captured.
Conclusions


BB stimulation before surgery can be successfully used as a nonpharmacological treatment to reduce morphine consumption in older adults who undergo knee replacement. The use of a noninvasive, safe, and inexpensive BB intervention can result in a positive effect on patients' postoperative recovery.",2020,"Regarding pain perception, no differences between the groups were captured.
","['Participants\n\n\nForty older adults at the hospital who were undergoing total knee joint replacement with spinal anesthesia participated in the study', '2 groups (n = 20 each), one receiving BBs stimulation with frequencies of 256 Hz in one ear and 260 Hz in the opposite ear producing a BB of 4 Hz (intervention group), and the other receiving acoustical stimulation at 256 Hz in both ears (control group', 'older adults who undergo knee replacement', 'Orthopedic Department of the Santa Maria Maddalena Hospital (Volterra [Pisa], Italy', 'older adults undergoing total knee replacement surgery', 'Older adults', 'older adult patients', 'After Total Knee Replacement Surgery']","['general anesthesia, binaural beat (BB) listening', 'inexpensive BB intervention', 'morphine']","['Feelings of anxiety', 'BBs, or acoustical stimulation', 'anxiety and feelings of pain', 'State-Trait Anxiety Inventory, and feelings of pain', 'unpleasant side effects', 'postoperative pain scores and discharge time', 'pain perception', 'postoperative, cumulative, self-administered morphine consumption, in mg, through a patient-controlled analgesia device']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0376249', 'cui_str': 'Frequency'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0229300', 'cui_str': 'Both ears'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0587525', 'cui_str': 'Orthopedic department'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",40.0,0.0762104,"Regarding pain perception, no differences between the groups were captured.
","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Tani', 'Affiliation': ''}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Vagheggini', 'Affiliation': ''}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Moretti', 'Affiliation': ''}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Del Colombo', 'Affiliation': ''}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Lehle', 'Affiliation': ''}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Campana', 'Affiliation': ''}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Labate', 'Affiliation': ''}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Tomaiuolo', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
1552,32412884,"Energy Drink before Exercise Did Not Affect Autonomic Recovery Following Moderate Aerobic Exercise: A Crossover, Randomized and Controlled Trial.","Introduction:  Energy drink (ED) intake could initiate physiological changes owing to its stimulant characteristics and, it improves endurance and athletic performance. We evaluated the acute effects of ED on autonomic heart rate (HR) control during recovery after a session of submaximal aerobic exercise. Method:  The study was completed by submitting 29 healthy males between 18 and 30 years old to three conventions: (A) Maximum exercise test by the adapted Bruce protocol; (B) Placebo protocol (PP) - water intake 15 minutes prior to exercise, rest in dorsal decubitus for 15 minutes followed by 5 minutes of treadmill running at 1% inclination, initial speed of 5 km/h for 5 minutes 25 minutes with 60% of the velocity consistent to the maximum oxygen consumption (VO2max), and finally 60 minutes of recovery at rest in the supine position; (C) Experimental protocol (PE) - similar to PP previously, but with ED intake 15 minutes before physical exercise. The time, frequency and geometric indexes of HR variability (HRV) were inspected before and after exercise. Results:  There was a significant (p < 0.05, <5%) effect on the HRV index (HR-nu and ms 2 , LF-nu and ms 2 , LF/HF, SD1, SDNN and RMSSD), indicating a reduction in HRV in the first 5 minutes after exercise in both protocols (PP and PE). Yet, no protocol interaction was detected, suggesting no effect of ED on HRV throughout recovery after submaximal aerobic exercise. Conclusion:  There was no significant effect of ED on the autonomic control of HR in the recovery phase after submaximal aerobic exercise.",2020,There was no significant effect of ED on the autonomic control of HR in the recovery phase after submaximal aerobic exercise.,['29 healthy males between 18 and 30\u2009years old to three conventions: (A'],"['submaximal aerobic exercise', 'Energy Drink before Exercise', 'Moderate Aerobic Exercise', 'Energy drink', 'Maximum exercise test by the adapted Bruce protocol; (B) Placebo protocol (PP) - water intake 15\u2009minutes prior to exercise, rest in dorsal decubitus for 15\u2009minutes followed by 5\u2009minutes of treadmill running at 1% inclination, initial speed of 5\u2009km/h for 5\u2009minutes 25\u2009minutes with 60% of the velocity consistent to the maximum oxygen consumption (VO2max), and finally 60\u2009minutes of recovery at rest in the supine position; (C) Experimental protocol (PE) - similar to PP previously, but with ED intake 15\u2009minutes before physical exercise']","['HRV index (HR-nu and ms 2 , LF-nu and ms 2 , LF/HF, SD1, SDNN and RMSSD', 'HRV', 'time, frequency and geometric indexes of HR variability (HRV', 'autonomic control of HR', 'endurance and athletic performance', 'Autonomic Recovery', 'autonomic heart rate (HR) control']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C3179078', 'cui_str': 'Energy drink'}, {'cui': 'C0585043', 'cui_str': 'Before exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0442713', 'cui_str': 'Bruce protocol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0013123', 'cui_str': 'Water intake'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439494', 'cui_str': 'km/h'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1861380', 'cui_str': 'Syndactyly, Type I'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C1959585', 'cui_str': 'Heart Rate Control'}]",29.0,0.0722657,There was no significant effect of ED on the autonomic control of HR in the recovery phase after submaximal aerobic exercise.,"[{'ForeName': 'Andrey Alves', 'Initials': 'AA', 'LastName': 'Porto', 'Affiliation': 'Department of Medicine, Federal University of São Paulo, UNIFESP, Sao Paulo, Brazil.'}, {'ForeName': 'Vitor E', 'Initials': 'VE', 'LastName': 'Valenti', 'Affiliation': 'Autonomic Nervous System Center, Sao Paulo State University, UNESP, Marilia, Brazil.'}, {'ForeName': 'Joice Anaize', 'Initials': 'JA', 'LastName': 'Tonon do Amaral', 'Affiliation': 'Faculty of Medicine (FMUSP), University of Sao Paulo, USP, Sao Paulo, Brazil.'}, {'ForeName': 'Cicero Jonas R', 'Initials': 'CJR', 'LastName': 'Benjamim', 'Affiliation': 'Development, Nutrition, Phytotherapy and Hygiene Research Group, University of Pernambuco, Petrolina, Brazil.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Garner', 'Affiliation': 'Cardiorespiratory Research Group, Department of Biological and Medical Sciences, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Celso', 'Initials': 'C', 'LastName': 'Ferreira', 'Affiliation': 'Department of Medicine, Federal University of São Paulo, UNIFESP, Sao Paulo, Brazil.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2020.1768175']
1553,32412917,Effect of Prescription Tongxin on Endothelial Progenitor Cells in Peripheral Blood.,"Context


Coronary heart disease (CHD) refers to a disease where coronary atherosclerosis induces stenosis or obstruction of the blood vessels. Endothelial progenitor cells (EPCs) function to protect and repair the vascular endothelium, and their functional activity state reflects the ability of the body to repair vascular damage. In the peripheral blood of patients with CHD, the density of EPCs decreases, and the function of EPCs is low.
Objective


This study aimed to investigate the effects of a China Food and Drug Administration (CFDA)-approved prescription medicine, Tongxin, on the density and function of endothelial progenitor cells (EPCs) in peripheral blood.
Design


In this study, a randomized, single blind, parallel controlled clinical trial was used. The single blind subjects were subjects.
Setting


The study took place in the Cardiology and Emergency Departments at Shanghai Municipal Hospital of Traditional Chinese Medicine in Shanghai, China.
Participants


Participants were 48 patients with coronary heart disease at the hospital.
Intervention


Participants were randomly divided into 2 groups (n = 24 each): a control group and an intervention group. Both groups received routine drug treatments, such as platelet inhibitors, nitrates, β-receptor blockers, statins, angiotensin-converting-enzyme (ACE) inhibitors, angiotensin II receptor antagonists (ARBs), and calcium blockers. The control group was treated with the Shexiang Baoxin Pill, while the intervention group was treated with prescription Tongxin. The course of treatment was 3 months for both groups.
Outcome Measures


Changes in the density and function of EPCs in the peripheral blood of the 2 groups were measured at baseline and postintervention, and the clinical efficacy of the 2 treatments was statistically analyzed.
Results


The density of EPCs was significantly higher in both groups after 3 months of treatment, compared to the densities at baseline (P < .05). The change in density between baseline and postintervention was significantly greater for the intervention group than for the control group (P < .05). For the control group, the proliferative vitality [optical density (OD)] value of the EPCs was significantly higher than that at baseline from the fourth day of treatment (P < .05). In the intervention group, the OD value was significantly higher than that at baseline from the first day of treatment (P < .05). Furthermore, the intervention group's cells began to enter the logarithmic growth phase of increase from the fifth day of treatment, and the group's increase as significantly higher than the control group's from the fifth to the seventh dayof treatment (P < .05 for all 3 days). Moreover, the total effective rate was higher in the intervention group than in the control group (P < .05).
Conclusions


Prescription Tongxin can stimulate the release of EPCs from the bone marrow to the peripheral blood of patients with CHD, can significantly increase the proliferation of EPCs in the peripheral blood, and can improve the clinical symptoms of patients. Its curative effect was greater than that of the control treatment.",2020,"Moreover, the total effective rate was higher in the intervention group than in the control group (P < .05).
","['Participants\n\n\nParticipants were 48 patients with coronary heart disease at the hospital', 'Setting\n\n\nThe study took place in the Cardiology and Emergency Departments at Shanghai Municipal Hospital of Traditional Chinese Medicine in Shanghai, China', 'Peripheral Blood']","['Shexiang Baoxin Pill', 'Prescription Tongxin', 'prescription Tongxin', 'control group and an intervention group', 'China Food and Drug Administration (CFDA)-approved prescription medicine, Tongxin', 'routine drug treatments, such as platelet inhibitors, nitrates, β-receptor blockers, statins, angiotensin-converting-enzyme (ACE) inhibitors, angiotensin II receptor antagonists (ARBs), and calcium blockers']","['proliferative vitality [optical density (OD)] value of the EPCs', 'OD value', 'change in density', 'total effective rate', 'clinical efficacy', 'density and function of EPCs in the peripheral blood', 'Endothelial Progenitor Cells', 'density of EPCs', 'proliferation of EPCs', 'Endothelial progenitor cells (EPCs) function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0020013', 'cui_str': 'Municipal Hospitals'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}]","[{'cui': 'C2351547', 'cui_str': 'shexiang baoxin'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032188', 'cui_str': 'Platelet Inhibitors'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}]","[{'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0439164', 'cui_str': 'OD units'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}]",48.0,0.0159673,"Moreover, the total effective rate was higher in the intervention group than in the control group (P < .05).
","[{'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Xue-Qin', 'Initials': 'XQ', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': ''}, {'ForeName': 'Xiao-Zhen', 'Initials': 'XZ', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Yi-Sheng', 'Initials': 'YS', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Qi-Mao', 'Initials': 'QM', 'LastName': 'Feng', 'Affiliation': ''}, {'ForeName': 'Li-Hua', 'Initials': 'LH', 'LastName': 'Lu', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
1554,32412952,Trends in Costs of Care and Utilization for Medicaid Patients With Diabetes in Accountable Care Communities.,"BACKGROUND/OBJECTIVES


Medicaid beneficiaries with diabetes have complex care needs. The Accountable Care Communities (ACC) Program is a practice-level intervention implemented by UnitedHealthcare to improve care for Medicaid beneficiaries. We examined changes in costs and utilization for Medicaid beneficiaries with diabetes assigned to ACC versus usual care practices.
RESEARCH DESIGN


Interrupted time series with concurrent control group analysis, at the person-month level. The ACC was implemented in 14 states, and we selected comparison non-ACC practices from those states to control for state-level variation in Medicaid program. We adjusted the models for age, sex, race/ethnicity, comorbidities, seasonality, and state-by-year fixed effects. We examined the difference between ACC and non-ACC practices in changes in the time trends of expenditures and hospital and emergency room utilization, for the 4 largest categories of Medicaid eligibility [Temporary Assistance to Needy Families, Supplemental Security Income (without Medicare), Expansion, Dual-Eligible].
SUBJECTS/MEASURES


Eligibility and claims data from Medicaid adults with diabetes from 14 states between 2010 and 2016, before and after ACC implementation.
RESULTS


Analyses included 1,200,460 person-months from 66,450 Medicaid patients with diabetes. ACC implementation was not associated with significant changes in outcome time trends, relative to comparators, for all Medicaid categories.
CONCLUSIONS


Medicaid patients assigned to ACC practices had no changes in cost or utilization over 3 years of follow-up, compared with patients assigned to non-ACC practices. The ACC program may not reduce costs or utilization for Medicaid patients with diabetes.",2020,"CONCLUSIONS


Medicaid patients assigned to ACC practices had no changes in cost or utilization over 3 years of follow-up, compared with patients assigned to non-ACC practices.","['66,450 Medicaid patients with diabetes', 'Medicaid beneficiaries with diabetes', 'Medicaid adults with diabetes from 14 states between 2010 and 2016, before and after ACC implementation', 'Medicaid patients with diabetes', 'Medicaid Patients With Diabetes in Accountable Care Communities', 'Medicaid beneficiaries with diabetes assigned to ACC versus usual care practices']",[],"['Costs of Care and Utilization', 'cost or utilization', 'costs or utilization', 'costs and utilization']","[{'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]",[],"[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",66450.0,0.0160042,"CONCLUSIONS


Medicaid patients assigned to ACC practices had no changes in cost or utilization over 3 years of follow-up, compared with patients assigned to non-ACC practices.","[{'ForeName': 'Tannaz', 'Initials': 'T', 'LastName': 'Moin', 'Affiliation': 'David Geffen School of Medicine at UCLA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Harwood', 'Affiliation': 'David Geffen School of Medicine at UCLA.'}, {'ForeName': 'Carol M', 'Initials': 'CM', 'LastName': 'Mangione', 'Affiliation': 'David Geffen School of Medicine at UCLA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Jackson', 'Affiliation': 'David Geffen School of Medicine at UCLA.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Ho', 'Affiliation': 'UnitedHealthcare, Minnetonka, MN.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Ettner', 'Affiliation': 'David Geffen School of Medicine at UCLA.'}, {'ForeName': 'O Kenrik', 'Initials': 'OK', 'LastName': 'Duru', 'Affiliation': 'David Geffen School of Medicine at UCLA.'}]",Medical care,['10.1097/MLR.0000000000001318']
1555,1797659,Hyperfractionation in advanced head and neck cancer.,"This preliminary study was undertaken to observe tumour response and normal tissue tolerance to hyperfractionation. This study showed encouraging locoregional control rate in advanced head and neck cancer. Responses T4 tumors are poor and are prone to recur. This indicates that probably greater dose is needed to control T4 disease. We used 7920 cGy for T4 and late T3 status tumour. This dose is well tolerated by patients. Control of T4 tumours may further be increased by increasing total dose, but in view of inadequate clear cut numerical data of tissue tolerance derived by L-Q = Linear Quadratic formula which is still under clinical trial, further increase in total dose cannot be overemphasized. Longer follow up is necessary to assess the long term control rate and late tissue reaction. There is a need of randomized controlled clinical trial to compare hyperfractionation and conventional fractionation. In next phase we are undertaking randomized study of twice daily, daily and weekly fractionation in advanced head and neck cancer.",1991,"Control of T4 tumours may further be increased by increasing total dose, but in view of inadequate clear cut numerical data of tissue tolerance derived by L-Q = Linear Quadratic formula which is still under clinical trial, further increase in total dose cannot be overemphasized.",['advanced head and neck cancer'],['Hyperfractionation'],['locoregional control rate'],"[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}]",[],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.03783,"Control of T4 tumours may further be increased by increasing total dose, but in view of inadequate clear cut numerical data of tissue tolerance derived by L-Q = Linear Quadratic formula which is still under clinical trial, further increase in total dose cannot be overemphasized.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dixit', 'Affiliation': 'SG Cancer Hospital, Indore.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Dvivedi', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rawat', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Gujral', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1556,32412970,The Increased Effectiveness of Resistance Training on Unstable vs. Stable Surfaces on Selected Measures of Physical Performance in Young Male Soccer Players.,"Sanchez-Sanchez, J, Raya-González, J, Ramirez-Campillo, R, Chaabene, H, Petisco, C, and Nakamura, FY. The increased effectiveness of resistance training on unstable vs. stable surfaces on selected measures of physical performance in young male soccer players. J Strength Cond Res XX(X): 000-000, 2020-To examine the effects of 10-week (2/wk) resistance training on stable vs. unstable surfaces on selected measures of physical performance in young male soccer players, national-level U19 players participated in this study. They were randomly allocated to an unstable resistance training group (uRT, n = 27) or a stable resistance training group (sRT, n = 28). Before and after the training, horizontal jumping with dominant (Hop D) and nondominant leg (Hop non-D), repeated sprint ability (RSA best time [RSAbest] and RSA mean time [RSAmean]), change-of-direction (COD) speed (Illinois COD test), and aerobic endurance (YoYo Intermittent Recovery Test Level 1 [YoYo IR1]) were assessed. To establish the effects of the interventions on the dependent variables, a 2 (group: uRT and sRT) × 2 (time: pre, post) analysis of variance with repeated measures on time was computed. A significant main effect of time was observed for Hop non-D, RSAbest, and RSAmean (p = 0.003-0.06, effect size [ES] = 0.06-0.15). Furthermore, significant group × time interactions were shown for RSAbest (p = 0.007, ES = 0.13) and RSAmean (p = 0.002, ES = 0.2). Post hoc analysis revealed significant pre- to post-training improvements for RSAbest (p = 0.002, ES = 0.35) and RSAmean (p = 0.0002, ES = 0.36) in the uRT. In the sRT, however, no significant pre-post performance changes were observed in RSAbest and RSAmean. In conclusion, 10 weeks of an in-season resistance training on unstable conditions in addition to regular soccer training was effective in improving repeated-sprint ability performance in youth male elite soccer players including maximal linear sprinting and the ability to perform repeated sprint.",2020,The increased effectiveness of resistance training on unstable vs. stable surfaces on selected measures of physical performance in young male soccer players.,"['Young Male Soccer Players', 'young male soccer players, national-level U19 players participated in this study', 'youth male elite soccer players', 'young male soccer players']","['J Strength Cond Res XX(X', 'unstable resistance training group (uRT, n = 27) or a stable resistance training', 'resistance training', 'resistance training on stable vs. unstable surfaces', 'regular soccer training', 'Resistance Training']","['repeated-sprint ability performance', 'sprint ability (RSA best time [RSAbest] and RSA mean time [RSAmean]), change-of-direction (COD) speed (Illinois COD test), and aerobic endurance (YoYo Intermittent Recovery Test Level 1 [YoYo IR1', 'Physical Performance', 'physical performance']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0246837', 'cui_str': ""1,1'-((4,4,7,7-tetramethyl)-4,7-diazaundecamethylene)bis-4-(3-methyl-2,3-dihydro(benzo-1,3-oxazole)-2-methylidine)quinolinium, tetraiodide""}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",28.0,0.0180962,The increased effectiveness of resistance training on unstable vs. stable surfaces on selected measures of physical performance in young male soccer players.,"[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sanchez-Sanchez', 'Affiliation': 'Group Planning and Assessment of Training and Athletic Performance, Pontifical University of Salamanca, Salamanca, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Raya-González', 'Affiliation': 'Faculty of Health Sciences, Isabel I University, Burgos, Spain.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ramirez-Campillo', 'Affiliation': 'Group Planning and Assessment of Training and Athletic Performance, Pontifical University of Salamanca, Salamanca, Spain.'}, {'ForeName': 'Helmi', 'Initials': 'H', 'LastName': 'Chaabene', 'Affiliation': 'Division of Training and Movement Sciences, Research Focus Cognition Sciences, University of Potsdam, Germany.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Petisco', 'Affiliation': 'Group Planning and Assessment of Training and Athletic Performance, Pontifical University of Salamanca, Salamanca, Spain.'}, {'ForeName': 'Fabio Y', 'Initials': 'FY', 'LastName': 'Nakamura', 'Affiliation': 'Group Planning and Assessment of Training and Athletic Performance, Pontifical University of Salamanca, Salamanca, Spain.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003590']
1557,32412960,Omega-3 fatty acid therapy for cardiovascular disease: justified or not?,"PURPOSE OF REVIEW


To discuss the current evidence regarding the relationship between omega-3 fatty acid intake and atherosclerotic cardiovascular disease (ASCVD) risk.
RECENT FINDINGS


Combined results from randomized controlled trials using low-dosage (≤1.8 g/day of ethyl esters) eicosapentaenoic acid (EPA) or EPA + docosahexaenoic acid (DHA) suggest a small benefit for reducing coronary heart disease risk. The Reduction of Cardiovascular Events with EPA-Intervention Trial (REDUCE-IT) that administered 4 g/day icosapent ethyl (IPE) to individuals on statin at high or very high ASCVD risk with elevated triglycerides demonstrated a 25% relative risk reduction in the composite primary endpoint (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization and unstable angina) for IPE vs. placebo, and a lower hazard for all prespecified individual endpoints other than total mortality. Several national organizations have recommended IPE for ASCVD risk reduction in populations aligning with REDUCE-IT; the Food and Drug Administration has approved IPE for ASCVD risk reduction. However, the Outcomes Study to Assess Statin Residual Risk Reduction with Epanova (EPA + DHA carboxylic acids) in High Cardiovascular Risk Patients with Hypertriglyceridemia was recently stopped for futility.
SUMMARY


At present, the best available evidence for a role of omega-3 fatty acids in ASCVD risk reduction is for 4 g/day of IPE, as an adjunct to statin therapy, for patients with ASCVD or diabetes mellitus and elevated triglycerides.",2020,"The Reduction of Cardiovascular Events with EPA-Intervention Trial (REDUCE-IT) that administered 4 g/day icosapent ethyl (IPE) to individuals on statin at high or very high ASCVD risk with elevated triglycerides demonstrated a 25% relative risk reduction in the composite primary endpoint (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization and unstable angina) for IPE vs. placebo, and a lower hazard for all prespecified individual endpoints other than total mortality.","['High Cardiovascular Risk Patients with Hypertriglyceridemia', 'patients with ASCVD or diabetes mellitus and elevated triglycerides']","['ethyl esters) eicosapentaenoic acid (EPA) or EPA + docosahexaenoic acid (DHA', 'Epanova (EPA + DHA carboxylic acids', 'omega-3 fatty acids', 'Omega-3 fatty acid therapy']","['Reduction of Cardiovascular Events', 'cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization and unstable angina']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C3884644', 'cui_str': '(trimethylsilyl)ethyl ester'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C4026303', 'cui_str': 'Epanova'}, {'cui': 'C0007066', 'cui_str': 'Carboxylic acid'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}]",,0.0504947,"The Reduction of Cardiovascular Events with EPA-Intervention Trial (REDUCE-IT) that administered 4 g/day icosapent ethyl (IPE) to individuals on statin at high or very high ASCVD risk with elevated triglycerides demonstrated a 25% relative risk reduction in the composite primary endpoint (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization and unstable angina) for IPE vs. placebo, and a lower hazard for all prespecified individual endpoints other than total mortality.","[{'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research, Addison, Illinois, Boca Raton, Florida.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Dicklin', 'Affiliation': 'Midwest Biomedical Research, Addison, Illinois, Boca Raton, Florida.'}]",Current opinion in cardiology,['10.1097/HCO.0000000000000741']
1558,32412986,Subarachnoid block and ultrasound-guided transversalis fascia plane block for caesarean section: A randomised placebo-controlled double-blind study.,"BACKGROUND


After caesarean section, maternal postoperative comfort is critical to allow the new mother to care for her baby. Insufficient pain relief during the postoperative period may delay maternal/infant bonding and, in addition, such pain has been linked to subsequent depression and chronic pain. Caesarean section is commonly performed with a Pfannenstiel incision, and a transversalis fascia plane (TFP) block provides postoperative analgesia in the T12 and L1 dermatomes.
OBJECTIVE


The aim of this study was to investigate the effect of the TFP block on postoperative opioid consumption and pain scores in patients undergoing caesarean section under spinal anaesthesia.
DESIGN


A prospective randomised controlled, double-blind study.
SETTINGS


Single-centre, academic hospital.
PARTICIPANTS


Sixty patients undergoing caesarean section.
INTERVENTIONS


The TFP group (n = 30) received an ultrasound-guided bilateral TFP block with 20 ml of 0.25% bupivacaine. The control group (n = 30) received 20 ml of saline bilaterally. Postoperative analgesia was given every 6 h with intravenous paracetamol 1 g and patient-controlled analgesia (PCA) with morphine.
MAIN OUTCOME MEASURES


Postoperative visual analogue pain scores, morphine consumption, rescue analgesia and opioid-related side effects were evaluated.
RESULTS


In the TFP group, the visual analogue pain scores were significantly lower at rest for 2 h after the operation (P = 0.011) and during active movement at 2, 4 and 8 h postoperatively (P = 0.014, <0.001 and 0.032, respectively). Morphine consumption in the first 24 h after surgery was significantly higher in the control group compared with the TFP group (38.5 ± 11.63 and 19.5 ± 8.33 mg, respectively; P < 0.001). The incidence of postoperative nausea and constipation were statistically higher in the control group than in the TFP group (P < 0.05). Patient satisfaction was significantly higher in the TFP group (P = 0.027).
CONCLUSION


A postoperative TFP block can reduce opioid consumption and relieve acute pain after a caesarean section under spinal anaesthesia.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04172727.",2020,The incidence of postoperative nausea and constipation were statistically higher in the control group than in the TFP group (P < 0.05).,"['Single-centre, academic hospital', 'patients undergoing caesarean section under spinal anaesthesia', 'caesarean section', 'Sixty patients undergoing caesarean section']","['transversalis fascia plane (TFP) block', 'ultrasound-guided bilateral TFP block with 20\u200aml of 0.25% bupivacaine', 'paracetamol 1 g and patient-controlled analgesia (PCA) with morphine', 'TFP', 'Subarachnoid block and ultrasound-guided transversalis fascia plane block', '20\u200aml of saline bilaterally', 'TFP block', 'placebo']","['Patient satisfaction', 'postoperative opioid consumption and pain scores', 'postoperative nausea and constipation', 'visual analogue pain scores', 'Morphine consumption', 'Postoperative visual analogue pain scores, morphine consumption, rescue analgesia and opioid-related side effects', 'acute pain']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0225232', 'cui_str': 'Transversalis fascia structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}]",60.0,0.485841,The incidence of postoperative nausea and constipation were statistically higher in the control group than in the TFP group (P < 0.05).,"[{'ForeName': 'Muhammed E', 'Initials': 'ME', 'LastName': 'Aydin', 'Affiliation': 'From the Department of Anaesthesiology and Reanimation, Ataturk University Faculty of Medicine (MEA, AMY, ECC, IA, EOA, AA), Clinical Research, Development and Design Application and Research Center, Ataturk University School of Medicine (MEA, AMY, ECC, AA), and Nenehatun State Hospital, Erzurum, Turkey (ZB).'}, {'ForeName': 'Zehra', 'Initials': 'Z', 'LastName': 'Bedir', 'Affiliation': ''}, {'ForeName': 'Ahmet M', 'Initials': 'AM', 'LastName': 'Yayik', 'Affiliation': ''}, {'ForeName': 'Erkan C', 'Initials': 'EC', 'LastName': 'Celik', 'Affiliation': ''}, {'ForeName': 'İrem', 'Initials': 'İ', 'LastName': 'Ates', 'Affiliation': ''}, {'ForeName': 'Elif O', 'Initials': 'EO', 'LastName': 'Ahiskalioglu', 'Affiliation': ''}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ahiskalioglu', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001222']
1559,32413915,Wet- versus dry-suction techniques for endoscopic ultrasound-guided fine-needle aspiration of solid lesions: a multicenter randomized controlled trial.,"BACKGROUND


The optimal sampling techniques for endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) remain unclear and have not been standardized. The aim of this study was to compare the wet-suction and dry-suction techniques for sampling solid lesions in the pancreas, mediastinum, and abdomen.
METHODS


This was a multicenter, crossover, randomized controlled trial with randomized order of sampling techniques. The 296 consecutive patients underwent EUS-FNA with 22G needles and were randomized in a ratio of 1:1 into two separate groups that received the dry-suction and wet-suction techniques in a different order. The primary outcome was to compare the histological diagnostic accuracy of dry suction and wet suction for malignancy. The secondary outcomes were to compare the cytological diagnostic accuracy and specimen quality.
RESULTS


Among the 269 patients with pancreatic (n = 161) and non-pancreatic (n = 108) lesions analyzed, the wet-suction technique had a significantly better histological diagnostic accuracy (84.9 % [95 % confidence interval (CI) 79.9 % - 89.0 %] vs. 73.2 % [95 %CI 67.1 % - 78.7 %];  P  = 0.001), higher specimen adequacy (94.8 % vs. 78.8 %;  P  < 0.001), and less blood contamination ( P  < 0.001) than the dry-suction technique. In addition, sampling non-pancreatic lesions with two passes of wet suction provided a histological diagnostic accuracy of 91.6 %.
CONCLUSIONS


The wet-suction technique in EUS-FNA generates better histological diagnostic accuracy and specimen quality than the dry-suction technique. Furthermore, sampling non-pancreatic lesions with two passes of EUS-FNA with wet suction may provide a definitive histological diagnosis when rapid on-site evaluation is not routinely available.",2020,The wet-suction technique in EUS-FNA generates better histological diagnostic accuracy and specimen quality than the dry-suction technique.,"['296 consecutive patients underwent EUS-FNA with 22G needles', '269 patients with pancreatic (n\u200a=\u200a161) and non-pancreatic (n\u200a=\u200a108) lesions']","['endoscopic ultrasound-guided fine-needle aspiration', 'endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA', 'dry-suction techniques', 'dry-suction and wet-suction techniques', 'wet-suction and dry-suction techniques']","['blood contamination', 'histological diagnostic accuracy and specimen quality', 'histological diagnostic accuracy of dry suction and wet suction for malignancy', 'higher specimen adequacy', 'histological diagnostic accuracy', 'cytological diagnostic accuracy and specimen quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1880510', 'cui_str': 'EUS-FNA'}, {'cui': 'C0450404', 'cui_str': '22G'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C1880510', 'cui_str': 'EUS-FNA'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205381', 'cui_str': 'Wet'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205471', 'cui_str': 'Cytologic'}]",296.0,0.146063,The wet-suction technique in EUS-FNA generates better histological diagnostic accuracy and specimen quality than the dry-suction technique.,"[{'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Rong-Hua', 'Initials': 'RH', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Ding', 'Affiliation': 'Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shi-Yun', 'Initials': 'SY', 'LastName': 'Tan', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ya-Qi', 'Initials': 'YQ', 'LastName': 'Duan', 'Affiliation': 'Institute of Pathology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Liang-Ru', 'Initials': 'LR', 'LastName': 'Zhu', 'Affiliation': 'Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ji-Wang', 'Initials': 'JW', 'LastName': 'Cao', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Gan', 'Initials': 'G', 'LastName': 'Shi', 'Affiliation': 'Department of Gastroenterology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xiao-Li', 'Initials': 'XL', 'LastName': 'Wu', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jin-Lin', 'Initials': 'JL', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yu-Chong', 'Initials': 'YC', 'LastName': 'Zhao', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shou-Jiang', 'Initials': 'SJ', 'LastName': 'Tang', 'Affiliation': 'Division of Digestive Diseases, Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Cheng', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}]",Endoscopy,['10.1055/a-1167-2214']
1560,32413002,Baseline and Clinical Factors Associated with Response to Amblyopia Treatment in a Randomized Clinical Trial.,"SIGNIFICANCE


We sought to identify baseline and clinical factors that were predictive of the response to amblyopia treatment. We report that binocular amblyopia treatment may be especially effective for moderate amblyopia in orthotropic children.
PURPOSE


We previously reported results from the primary cohort (n = 28) enrolled in a randomized clinical trial (NCT02365090), which found that binocular amblyopia treatment was more effective than patching. Enrollment of an additional 20 children was pre-planned to provide the opportunity to examine factors that may be predictive of response to amblyopia treatment.
METHODS


Forty-eight children (4 to 10 years old) were enrolled, with 24 randomized to contrast-rebalanced binocular game treatment (1 hour a day, 5 days a week) and 24 to patching treatment (2 hours a day, 7 days a week). The primary outcome was change in amblyopic eye best-corrected visual acuity at the 2-week visit. Baseline factors examined were age at enrollment, visual acuity, stereoacuity, and suppression. Clinical factors were etiology, age at diagnosis, prior treatment, and ocular alignment.
RESULTS


At 2 weeks, visual acuity improvement was significantly greater with the binocular game than patching. Children with moderate amblyopia and orthotropia had more visual acuity improvement with binocular game play than did those with severe amblyopia. In addition, children who spent more time playing the binocular game had more improvement. We were not able to confidently identify any baseline or clinical factors that were associated with response to patching treatment.
CONCLUSIONS


Binocular amblyopia treatment was more effective among orthotropic children with moderate amblyopia than among children with microtropia or severe amblyopia.",2020,"At 2 weeks, visual acuity improvement was significantly greater with the binocular game than patching.","['orthotropic children with moderate amblyopia than among children with microtropia or severe amblyopia', 'Children with moderate amblyopia and orthotropia', 'Forty-eight children (4 to 10 years old']","['binocular amblyopia treatment', 'Binocular amblyopia treatment', 'contrast-rebalanced binocular game treatment']","['change in amblyopic eye best-corrected visual acuity', 'visual acuity, stereoacuity, and suppression', 'visual acuity improvement', 'time playing the binocular game']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0271356', 'cui_str': 'Microstrabismus'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1275505', 'cui_str': 'Stereoscopic acuity'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}]",48.0,0.177459,"At 2 weeks, visual acuity improvement was significantly greater with the binocular game than patching.","[{'ForeName': 'Eileen E', 'Initials': 'EE', 'LastName': 'Birch', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}, {'ForeName': 'Reed M', 'Initials': 'RM', 'LastName': 'Jost', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}, {'ForeName': 'Krista R', 'Initials': 'KR', 'LastName': 'Kelly', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}, {'ForeName': 'Joel N', 'Initials': 'JN', 'LastName': 'Leffler', 'Affiliation': ""Children's Eye Care of North Texas, PA, Plano, Texas.""}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Dao', 'Affiliation': 'ABC Eyes Pediatric Ophthalmology, PA, Dallas, Texas.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Beauchamp', 'Affiliation': 'ABC Eyes Pediatric Ophthalmology, PA, Dallas, Texas.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001514']
1561,32413420,Increased risk of cardiac conduction abnormalities with ribociclib in patients with metastatic breast cancer: A combined analysis of phase III randomized controlled trials.,,2020,,['patients with metastatic breast cancer'],['ribociclib'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}]","[{'cui': 'C4045494', 'cui_str': 'ribociclib'}]",[],,0.0775656,,"[{'ForeName': 'Somedeb', 'Initials': 'S', 'LastName': 'Ball', 'Affiliation': 'Department of Internal Medicine, Texas Tech University Health Sciences Center, Lubbock, TX, USA. Electronic address: drsomedeb@gmail.com.'}, {'ForeName': 'Sriman', 'Initials': 'S', 'LastName': 'Swarup', 'Affiliation': 'Division of Hematology & Medical Oncology, Texas Tech University Health Sciences Center, Lubbock, TX, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Sultan', 'Affiliation': 'Division of Hematology & Medical Oncology, Texas Tech University Health Sciences Center, Lubbock, TX, USA.'}, {'ForeName': 'Kyaw Zin', 'Initials': 'KZ', 'LastName': 'Thein', 'Affiliation': 'Division of Hematology & Medical Oncology, Texas Tech University Health Sciences Center, Lubbock, TX, USA.'}]",Hematology/oncology and stem cell therapy,['10.1016/j.hemonc.2020.03.001']
1562,32413431,Anchor versus Suture for Attachment of Vaginal Mesh in Robotic-Assisted Sacrocolpopexy: A Randomized Clinical Trial.,"BACKGROUND


Vaginal mesh attachment can be one of the most time intensive components of minimally invasive sacrocolpopexy.
OBJECTIVE


To assess the impact on the duration of surgery of using absorbable anchors compared to interrupted sutures for vaginal mesh attachment in robotic-assisted sacrocolpopexy.
STUDY DESIGN


This is a single-masked, randomized clinical trial at 2 clinical sites in women with pelvic organ prolapse undergoing robotic-assisted sacrocolpopexy. Participants were randomized to either interrupted delayed-absorbable anchors or sutures for the vaginal mesh attachment portion of the case. Participants completed validated questionnaires at baseline, 6 weeks, 6 months, and 12 months after surgery. A certified examiner masked to the treatment arm performed a clinical examination with assessment of POPQ, mesh exposure, and overall appearance of vaginal walls using a 10-cm visual analog scale at each follow-up visit. The primary outcome was the vaginal mesh attachment time. Categorical variables were compared using chi-square or Fischer's Exact test, whereas continuous variables were compared using Student's t test or Mann-Whitney U test as appropriate. An intention-to-treat analysis was performed.
RESULTS


Fifty-three participants were randomized, 26 to mesh attachment with anchor, 27 to mesh attachment with suture, and 81% (21/26) and 93% (25/27) had 12-month follow up respectively. There were no significant differences between groups in age (p=0.12), BMI (p=0.23), stage of prolapse (p=0.97), or other preoperative factors. Mesh attachment interval time was faster in the anchor compared to suturing arm (12.2±7.8 vs. 21.2± 5.2 min, p<0.001), while sacrocolpopexy times (107.6± 33.2 vs 109.8± 21.2, p=0.774) were not different. VAS for surgeon ease of placement (p=0.16), appearance of mesh attachment (p=0.07), and global satisfaction with use of attachment type (p=0.65) were similar between the arms. There was no difference in perioperative adverse events rates between arms and by 12 months follow-up there were no sacrocolpopexy mesh, anchor, or suture exposures. There was no difference in outcomes at 12 months including composite failure (10% vs 12%, p=0.79), patient global impression of improvement (1.06 vs. 1.19, p=0.27), or patient pelvic pain (9.81 vs. 9.67, p=0.56).
CONCLUSIONS


In patients undergoing robotic-assisted sacrocolpopexy the anchor vaginal mesh attachment technique required significantly less time than suturing. There was no difference between techniques in complications, failure, surgeon or patient-reported outcomes through 12 months of follow-up. Mesh attachment during sacrocolpopexy can be performed in less time using the anchor technique, providing surgeons another surgical technique for this procedure.",2020,"There was no difference between techniques in complications, failure, surgeon or patient-reported outcomes through 12 months of follow-up.","['patients undergoing', 'women with pelvic organ prolapse undergoing robotic-assisted sacrocolpopexy', 'Fifty-three participants']","['robotic-assisted sacrocolpopexy the anchor vaginal mesh attachment technique', 'VAS', 'Anchor versus Suture for Attachment of Vaginal Mesh in Robotic-Assisted Sacrocolpopexy', 'interrupted delayed-absorbable anchors or sutures', 'absorbable anchors compared to interrupted sutures']","['Mesh attachment interval time', 'patient global impression of improvement', 'patient pelvic pain', 'composite failure', 'vaginal mesh attachment time', 'BMI (p=0.23), stage of prolapse', 'perioperative adverse events rates', 'global satisfaction', 'appearance of mesh attachment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0554325', 'cui_str': 'Sacrocolpopexy'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0554325', 'cui_str': 'Sacrocolpopexy'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4706333', 'cui_str': 'Patient Global Impression of Improvement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]",53.0,0.29178,"There was no difference between techniques in complications, failure, surgeon or patient-reported outcomes through 12 months of follow-up.","[{'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Berger', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of OB/GYN, Kaiser Permanente-San Diego; Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics, Gynecology and Reproductive Science, University of California San Diego. Electronic address: alexanderbergermd@gmail.com.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Tan-Kim', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of OB/GYN, Kaiser Permanente-San Diego.'}, {'ForeName': 'Shawn A', 'Initials': 'SA', 'LastName': 'Menefee', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of OB/GYN, Kaiser Permanente-San Diego.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.05.018']
1563,32413595,Double trouble: Do symptom severity and duration interact to predicting treatment outcomes in adolescent depression?,"Studies suggest that depression severity and duration interact to predict outcomes in depression treatment. To our knowledge, no study has explored this question in a sample with a placebo control, two therapies, and their combination nor with adolescents. We used data from the Treatment of Adolescent Depression Study (N = 439), in which adolescent were randomized to placebo (PBO), cognitive-behavioral therapy (CBT), antidepressants medications (MEDs), or their combination (COMB). We explore the interaction between depression severity, chronicity, and treatments (vs. placebo) in predicting outcomes. There was interaction between severity and chronicity when comparing COMB and CBT with PBO, but not MEDs. In non-chronic depression, the effects of CBT were inversely related to severity to the point that CBT appeared iatrogenic with more severe depression. In chronic depression, the effects of CBT did not vary by severity, but the relative effects of COMB grew, being smallest in milder, more dythimic-like depression, and largest in chronic-severe depression. These findings support calls to classify depression by severity and chronicity as well efforts to risk stratify patients to different intensity of care according to these variables.",2020,"In non-chronic depression, the effects of CBT were inversely related to severity to the point that CBT appeared iatrogenic with more severe depression.",['Adolescent Depression Study (N\xa0=\xa0439'],"['CBT', 'placebo (PBO), cognitive-behavioral therapy (CBT), antidepressants medications (MEDs), or their combination (COMB', 'placebo']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",[],,0.0183832,"In non-chronic depression, the effects of CBT were inversely related to severity to the point that CBT appeared iatrogenic with more severe depression.","[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Lorenzo-Luaces', 'Affiliation': 'Department of Psychological and Brain Sciences, Indiana University, Bloomington, IN, USA. Electronic address: lolorenz@indiana.edu.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Rodriguez-Quintana', 'Affiliation': 'Department of Psychological and Brain Sciences, Indiana University, Bloomington, IN, USA.'}, {'ForeName': 'Allen J', 'Initials': 'AJ', 'LastName': 'Bailey', 'Affiliation': 'Department of Psychological and Brain Sciences, Indiana University, Bloomington, IN, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103637']
1564,31570123,An online mindfulness-based intervention for undergraduate pharmacy students: Results of a mixed-methods feasibility study.,"INTRODUCTION


Stress negatively impacts pharmacy students' physical and mental health. Mindfulness has been shown to improve student wellbeing. The purpose of this study was to assess the feasibility and acceptability of an online mindfulness-based intervention and determine its effect on student wellbeing.
METHODS


A quasi-randomised controlled trial was conducted at four pharmacy schools in Ireland. The intervention group took part in a four-week online mindfulness course. The control group received usual education, with delayed access to the course. Participants completed the Perceived Stress Scale, the General Health Questionnaire, the Jefferson Scale of Empathy - Health Profession Student version, the Maslach Burnout Inventory Student Survey (MBI-SS), and the Five Facet Mindfulness Questionnaire at baseline and post-intervention. Answers provided to questions about the experience of participating in the course were analysed using thematic analysis.
RESULTS


Of the 52 participants, no significant differences were found between the intervention and control groups at baseline. Post-intervention, an increase in professional efficacy, as measured by the MBI-SS, was found in the intervention group (p = 0.004). There was also an increase in observing scores (p = 0.003). Males showed greater improvements in stress (p = 0.04) and non-judgement (p = 0.03) levels. Only females demonstrated improvement in professional efficacy (p = 0.002). Participants self-reported stress reduction and increased awareness of emotions.
CONCLUSION


This study provides insights into the feasibility and acceptability of an online mindfulness course for pharmacy students. Findings will inform the future design and implementation of larger studies.",2019,Males showed greater improvements in stress (p = 0.04) and non-judgement (p = 0.03) levels.,"['pharmacy students', 'undergraduate pharmacy students', 'A quasi-randomised controlled trial was conducted at four pharmacy schools in Ireland', '52 participants']","['online mindfulness-based intervention', 'usual education']","['professional efficacy', 'Perceived Stress Scale, the General Health Questionnaire, the Jefferson Scale of Empathy - Health Profession Student version, the Maslach Burnout Inventory Student Survey (MBI-SS), and the Five Facet Mindfulness Questionnaire', 'stress', 'awareness of emotions', 'observing scores', 'feasibility and acceptability']","[{'cui': 'C0038497', 'cui_str': 'Pharmacy Student'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0036381', 'cui_str': 'Schools, Pharmacy'}, {'cui': 'C0022067', 'cui_str': 'Ireland, Republic of'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0582653', 'cui_str': 'Perceived stress scale (assessment scale)'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",52.0,0.0251241,Males showed greater improvements in stress (p = 0.04) and non-judgement (p = 0.03) levels.,"[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': ""O'Driscoll"", 'Affiliation': 'Pharmaceutical Care Research Group, School of Pharmacy, University College Cork, Ireland. Electronic address: michelle.odriscoll@ucc.ie.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Byrne', 'Affiliation': 'Pharmaceutical Care Research Group, School of Pharmacy, University College Cork, Ireland. Electronic address: Stephen.byrne@ucc.ie.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Byrne', 'Affiliation': 'Mindfulness Centre for Professional Training in Ireland, 33 Pembroke Street Lower, Dublin 2, Ireland.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Lambert', 'Affiliation': 'School of Applied Psychology, University College Cork, Ireland. Electronic address: sharon.lambert@ucc.ie.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Sahm', 'Affiliation': 'Pharmaceutical Care Research Group, School of Pharmacy, University College Cork, Ireland; Pharmacy Department, Mercy University Hospital, Cork, Ireland. Electronic address: l.sahm@ucc.ie.'}]",Currents in pharmacy teaching & learning,['10.1016/j.cptl.2019.05.013']
1565,31859593,Association of cognitive biases with human papillomavirus vaccine hesitancy: a cross-sectional study.,"Given the link between vaccine hesitancy and vaccine-preventable disease outbreaks, it is critical to examine the cognitive processes that contribute to the development of vaccine hesitancy, especially among parents of adolescents. We conducted a secondary analysis of baseline data from a two-phase randomized trial on human papillomavirus to investigate how vaccine hesitancy and intent to vaccinate are associated with six decision-making factors: base rate neglect, conjunction fallacy, sunk cost bias, present bias, risk aversion, and information avoidance. We recruited 1,413 adults residing in the United States with at least one daughter aged 9-17 years old through an online survey on Amazon Mechanical Turk. Vaccine hesitancy, intent to vaccinate, and susceptibility to cognitive biases was measured through a series of brief questionnaires. 1,400 participants were in the final analyzed sample. Most participants were white (74.1%), female (71.6%), married (75.3%), and had a college or graduate/professional education (88.8%). Conjunction fallacy, sunk cost bias, information avoidance, and present bias may be associated with vaccine hesitancy. Intent to vaccinate may be associated with information avoidance. These results suggest that cognitive biases play a role in developing parental vaccine hesitancy and vaccine-related behavior.",2020,"Vaccine hesitancy, intent to vaccinate, and susceptibility to cognitive biases was measured through a series of brief questionnaires.","['1,413 adults residing in the United States with at least one daughter aged 9-17\xa0years old through an online survey on Amazon Mechanical Turk', 'Most participants were white (74.1%), female (71.6%), married (75.3%), and had a college or graduate/professional education (88.8', 'parents of adolescents', '1,400 participants were in the final analyzed sample']",['human papillomavirus vaccine hesitancy'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0337911', 'cui_str': 'Turks (ethnic group)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0013647', 'cui_str': 'Education, Professional'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0152032', 'cui_str': 'Delay when starting to pass urine (finding)'}]",[],1400.0,0.0582943,"Vaccine hesitancy, intent to vaccinate, and susceptibility to cognitive biases was measured through a series of brief questionnaires.","[{'ForeName': 'Tiffany D', 'Initials': 'TD', 'LastName': 'Pomares', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Buttenheim', 'Affiliation': 'Department of Family and Community Health, University of Pennsylvania School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Avnika B', 'Initials': 'AB', 'LastName': 'Amin', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Joyce', 'Affiliation': 'Department of Family and Community Health, University of Pennsylvania School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Rachael M', 'Initials': 'RM', 'LastName': 'Porter', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Bednarczyk', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Saad B', 'Initials': 'SB', 'LastName': 'Omer', 'Affiliation': 'Yale School of Medicine, Yale Institute for Global Health, New Haven, CT, USA.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1698243']
1566,32412991,An Exploration of Health Behaviors in a Mind-Body Resilience Intervention for Parents of Children with Developmental Disabilities.,"OBJECTIVE


Parents of children with special needs such as learning and attentional disabilities (LADs) and autism spectrum disorder (ASD) are at high risk for stress-related disorders. The demands of parenting may compete with time for self-care behaviors such as physical activity, healthy eating, and adequate sleep. The objective was to describe health behaviors among this understudied population and assess the changes after a resilience intervention.
METHODS


This was a secondary data analysis of a randomized controlled pilot virtual mind-body resilience intervention (Stress Management and Resiliency Training: A Relaxation Response Resiliency Program) trial for parents of children with LADs (n = 52) and ASD (n = 47). Parents completed self-report questionnaires about their weekly physical activity, eating behaviors, sleep duration, and fatigue before and after the 8-week intervention. Descriptive statistics and pre-post intervention effect sizes (Cohen's d) were calculated.
RESULTS


Both parent groups reported suboptimal levels of health behaviors at baseline, but ASD parents reported lower health behaviors than LAD parents. LAD parents improved more on physical activity, with a higher percentage meeting recommendations at postintervention follow-up (d = 0.71) than ASD parents (d = 0.01). Eating behaviors showed small effect size improvements for both groups. Although sleep duration improved only with small or medium effect sizes for both groups, ASD parents rated their fatigue lower after the intervention (d = 0.81).
CONCLUSION


Parents of children with special needs who participated in a virtual resilience intervention demonstrated suboptimal health behaviors. There is a need for targeted interventions for health behaviors that can promote resilience in these high-stress populations.",2020,"Although sleep duration improved only with small or medium effect sizes for both groups, ASD parents rated their fatigue lower after the intervention (d = 0.81).
","['parents of children with LADs (n = 52) and ASD (n = 47', 'Parents of Children with Developmental Disabilities', 'Parents of children with special needs such as learning and attentional disabilities (LADs) and autism spectrum disorder (ASD', 'Parents of children with special needs who participated in a']","['body resilience intervention (Stress Management and Resiliency Training', 'Mind-Body Resilience Intervention', 'virtual resilience intervention']","['self-report questionnaires about their weekly physical activity, eating behaviors, sleep duration, and fatigue', 'sleep duration', 'physical activity', 'suboptimal health behaviors', 'health behaviors', 'suboptimal levels of health behaviors']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0008073', 'cui_str': 'Developmental disorder'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018759', 'cui_str': 'Health status'}]",52.0,0.0551803,"Although sleep duration improved only with small or medium effect sizes for both groups, ASD parents rated their fatigue lower after the intervention (d = 0.81).
","[{'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Millstein', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Olivia J', 'Initials': 'OJ', 'LastName': 'Lindly', 'Affiliation': 'Department of Health Sciences, Northern Arizona University, Tucson, AZ.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Luberto', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Giselle K', 'Initials': 'GK', 'LastName': 'Perez', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Gabrielle N', 'Initials': 'GN', 'LastName': 'Schwartz', 'Affiliation': 'Health Policy Research Center, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kuhlthau', 'Affiliation': 'Division of General Academic Pediatrics, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}]",Journal of developmental and behavioral pediatrics : JDBP,['10.1097/DBP.0000000000000813']
1567,32413530,Cranberry capsules are not superior to placebo capsules in managing acute non-haemorrhagic radiation cystitis in prostate cancer patients: a phase III double blinded randomised placebo controlled clinical trial.,"PURPOSE


Acute radiation cystitis affects the quality of life of many prostate cancer patients. A previous pilot study suggested that cranberry capsules may decrease some of the symptoms of acute radiation cystitis. Here we further test their effectiveness in a multicentre double blinded placebo-controlled clinical trial.
MATERIAL AND METHODS


A total of 108 prostate cancer patients were recruited at three New Zealand hospitals between September 2016 and January 2019. Out of this cohort, 101 patients provided datasets for analysis (51 men on cranberry capsules and 50 men on beetroot-containing placebo capsules). Patients took two capsules each morning during RT and for 2 weeks after completion of RT. Three measures were used to assess cystitis severity: modified RTOG, O'Leary interstitial cystitis scale and a sensitive novel radiation induced cystitis assessment scale (RICAS). Cystitis severity was scored at baseline and weekly thereafter during RT and for two weeks after completion of RT. Radiation protocols were stratified to conventional fractionation or hypo-fractionated radiation therapy (CHHiP) to the prostate or radiation to the prostate bed.
RESULTS


Cranberry capsules performed significantly worse than placebo capsules with respect to day time frequency and bladder control, using the more sensitive RICAS scale. No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland.
CONCLUSION


Cranberry capsules were not superior to beetroot-containing placebo capsules in managing radiation cystitis in our prostate patient cohort. RICAS may be a useful tool for measuring radiation cystitis in future studies.",2020,"No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland.
","['101 patients provided datasets for analysis (51 men on cranberry capsules and 50 men on beetroot-containing placebo capsules', 'many prostate cancer patients', 'prostate cancer patients', '108 prostate cancer patients were recruited at three New Zealand hospitals between September 2016 and January 2019']","['conventional fractionation or hypo-fractionated radiation therapy (CHHiP', 'Cranberry capsules', 'placebo capsules', 'RICAS', 'cranberry capsules', 'placebo']","['Cystitis severity', 'sensitive RICAS scale', 'symptoms of acute radiation cystitis', 'cystitis severity', ""cystitis severity: modified RTOG, O'Leary interstitial cystitis scale and a sensitive novel radiation induced cystitis assessment scale (RICAS""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0453112', 'cui_str': 'Beetroot'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0524811', 'cui_str': 'Dose Fractionation, Radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}]","[{'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0403637', 'cui_str': 'Acute radiation cystitis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C0205314', 'cui_str': 'New'}]",108.0,0.254135,"No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland.
","[{'ForeName': 'Patries M', 'Initials': 'PM', 'LastName': 'Herst', 'Affiliation': 'Department of Radiation Therapy, University of Otago, Wellington, New Zealand. Electronic address: patries.herst@otago.ac.nz.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Aumata', 'Affiliation': 'Radiation Oncology Department, Southern Blood and Cancer Centre, Dunedin Hospital, Dunedin, NZ.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Sword', 'Affiliation': 'Kathleen Kilgour Centre, Tauranga, NZ.'}, {'ForeName': 'Rowan', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Auckland Radiation Oncology, Epsom, Auckland, NZ.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Purdie', 'Affiliation': ""Dean's Department, University of Otago, Wellington, New Zealand.""}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Costello', 'Affiliation': 'Radiation Oncology Department, Southern Blood and Cancer Centre, Dunedin Hospital, Dunedin, NZ.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.006']
1568,31436705,A Prospective Study on Child Morbidity and Gut Microbiota in Rural Malawi.,"OBJECTIVES


The determinants of gut microbiota composition and its effects on common childhood illnesses are only partly understood, especially in low-income settings. The aim of the present study was to investigate whether morbidity predicts gut microbiota composition in Malawian children and whether microbiota predicts subsequent morbidity. We tested the hypothesis that common infectious disease symptoms would be predictive of lower microbiota maturity and diversity.
METHODS


We used data from 631 participants in a randomized-controlled nutrition intervention trial, in which a small-quantity lipid-based nutrient supplement was provided to pregnant and lactating mothers and their children at 6 to 18 months of age. Fecal samples were collected from the children at 6, 12, 18, and 30 months of age and analyzed using 16S rRNA sequencing. Microbiota variables consisted of measures of microbiota diversity (Shannon Index), microbiota maturity (microbiota-for-age z score), and the relative abundances of taxa. Morbidity variables included gastrointestinal and respiratory symptoms and fever.
RESULTS


Diarrhea and respiratory symptoms from 11 to 12 months were predictive of lower microbiota-for-age z score and higher Shannon Index, respectively (P = 0.035 and P = 0.023). Morbidity preceding sample collection was predictive of the relative abundances of several bacterial taxa at all time points. Higher microbiota maturity and diversity at 6 months were predictive of a lower incidence rate of fever in the subsequent 6 months (P = 0.007 and P = 0.031).
CONCLUSIONS


Our findings generally do not support the hypothesis that morbidity prevalence predicts a subsequent decrease in gut microbiota maturity or diversity in rural Malawian children. Certain morbidity symptoms may be predictive of microbiota maturity and diversity and relative abundances of several bacterial taxa. Furthermore, microbiota diversity and maturity may be associated with the subsequent incidence of fever.",2019,Higher microbiota maturity and diversity at 6 months were predictive of a lower incidence rate of fever in the subsequent 6 months (,"['Child Morbidity and Gut Microbiota in Rural Malawi', 'pregnant and lactating mothers and their children at 6 to 18 months of age', 'Malawian children', 'rural Malawian children', '631 participants']",['small-quantity lipid-based nutrient supplement'],"['gastrointestinal and respiratory symptoms and fever', 'microbiota diversity (Shannon Index), microbiota maturity (microbiota-for-age z score), and the relative abundances of taxa', 'incidence rate of fever', 'Diarrhea and respiratory symptoms', 'gut microbiota maturity or diversity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}]","[{'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449989', 'cui_str': 'Maturity (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}]",631.0,0.0869198,Higher microbiota maturity and diversity at 6 months were predictive of a lower incidence rate of fever in the subsequent 6 months (,"[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Kortekangas', 'Affiliation': 'Faculty of Medicine and Health Technology, Center for Child Health Research, Tampere University, Tampere, Finland.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Young', 'Affiliation': 'Program in International and Community Nutrition, University of California, Davis, CA.'}, {'ForeName': 'Yin B', 'Initials': 'YB', 'LastName': 'Cheung', 'Affiliation': 'Program in Health Services and Systems Research and Centre for Quantitative Medicine, Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Yue-Mei', 'Initials': 'YM', 'LastName': 'Fan', 'Affiliation': 'Faculty of Medicine and Health Technology, Center for Child Health Research, Tampere University, Tampere, Finland.'}, {'ForeName': 'Josh M', 'Initials': 'JM', 'LastName': 'Jorgensen', 'Affiliation': 'Program in International and Community Nutrition, University of California, Davis, CA.'}, {'ForeName': 'Arox W', 'Initials': 'AW', 'LastName': ""Kamng'ona"", 'Affiliation': 'Program in International and Community Nutrition, University of California, Davis, CA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chaima', 'Affiliation': 'School of Public Health and Family Medicine, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Ashorn', 'Affiliation': 'Faculty of Medicine and Health Technology, Center for Child Health Research, Tampere University, Tampere, Finland.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Program in International and Community Nutrition, University of California, Davis, CA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': 'School of Public Health and Family Medicine, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': 'Faculty of Medicine and Health Technology, Center for Child Health Research, Tampere University, Tampere, Finland.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002435']
1569,27840340,The Impact of Aerobic Exercise on Quality of Life in Women with Breast Cancer: A Randomized Controlled Trial.,"BACKGROUND


The women with breast cancer experience high rates of morbidity due to different treatments. The objective of this study was to evaluate the role of aerobic exercise in the quality of life (QoL) among women suffering from breast cancer in Hamadan, western Iran.
METHODS


Participants who had consummated the eligibility criteria were randomly assigned in exercise group (n=30) and control group (n=30). Written informed consent was obtained from all participants. The mean age was 42.70 ±9.6 and 43.50 ±8.60 yr old in exercise and control groups, respectively. The quality of life was assessed by two widely used standard questionnaires (EORTC QLQ-C30 and EORTC QLQ-BR23). The exercise group received supervised exercise 2 days per week for 10 weeks. Through two stages (before and after intervention) these groups were evaluated. Analyzing the data was performed by SPSS/20.0, using t-test, chi-squared and ANCOVA. P<0.05 was regarded as significant level.
RESULTS


The global health status QoL, based on EORTC QLQ-C30, developed significantly in the exercise group (48.76±24.96 vs. 81.79±16.34) in comparison with the controls (47.75 ±15.73 vs. 52.88 ±14.51) (P<0.001). The exercise intervention was associated with substantial development in total score of functions and symptoms of QoL using EORTC QLQ-BR23 (P<0.001).
CONCLUSIONS


The statistically and clinically crucial developments were indicated in functions and symptoms of QoL in response to exercise in breast cancer women.",2016,"The exercise intervention was associated with substantial development in total score of functions and symptoms of QoL using EORTC QLQ-BR23 (P<0.001).
","['Women with Breast Cancer', 'breast cancer women', 'Participants who had consummated the eligibility criteria', 'women suffering from breast cancer in Hamadan, western Iran', 'women with breast cancer', 'The mean age was 42.70 ±9.6 and 43.50 ±8.60 yr old in exercise and control groups, respectively']","['aerobic exercise', 'exercise group', 'Aerobic Exercise', 'supervised exercise']","['Quality of Life', 'global health status QoL, based on EORTC QLQ-C30', 'quality of life', 'standard questionnaires (EORTC QLQ-C30 and EORTC QLQ-BR23', 'quality of life (QoL', 'total score of functions and symptoms of QoL using EORTC QLQ-BR23 (P<0.001']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0703816,"The exercise intervention was associated with substantial development in total score of functions and symptoms of QoL using EORTC QLQ-BR23 (P<0.001).
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Shobeiri', 'Affiliation': 'Mother & Child Care Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Seyedeh Zahra', 'Initials': 'SZ', 'LastName': 'Masoumi', 'Affiliation': 'Mother & Child Care Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Nikravesh', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Rashid', 'Initials': 'R', 'LastName': 'Heidari Moghadam', 'Affiliation': 'Department of Ergonomics, School of Public Health, Research Center for Health Sciences, Hamadan University of Medical Sciences, Hamadan, Iran. dr_haidari@yahoo.com.'}, {'ForeName': 'Manoochehr', 'Initials': 'M', 'LastName': 'Karami', 'Affiliation': 'Department of Epidemiology, School of Public Health, Social Determinants of Health Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Journal of research in health sciences,[]
1570,32413174,Conservative vs Surgical Treatment of Impacted Femoral Neck Fracture in Patients 75 Years and Older.,"OBJECTIVE


To evaluate the safety and effectiveness of conservative treatment (CST), internal fixation (IF), and hemiarthroplasty (HA) in treating patients older than 75 years with impacted femoral neck fracture (IFNF).
DESIGN


A randomized clinical trial to compare clinical outcomes of CST, IF, and HA in IFNF patients older than 75 years with a 1:1:1 ratio.
SETTING


Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
PARTICIPANTS


A total of 154 patients with IFNF aged between 75 and 97 years.
INTERVENTION


Patients with IFNF were allocated to CST, IF, and HA. They all received a 36-month follow-up.
MEASUREMENTS


All patients were evaluated by Harris hip score (HHS) (primary outcome) for hip function, European Quality of Life-5 Dimensions (EQ-5D) index scores for health-related quality of life, and visual analogue scale score for hip pain. Operation duration, blood loss, mortality, union rate, complications, and reoperation were also recorded. Assessors were blind to the type of treatment.
RESULTS


The baseline parameters of the three groups were similar. IF group had much lower blood loss than HA group (P < .05), while no significant difference in operative duration was found between the two groups (P > .05). HHS in HA group was significantly higher at 1, 3, and 6 months (P < .05), but no significant difference in HHS was found between CST and IF groups at any of the time points during the overall follow-up (P > .05). EQ-5D index score was higher in HA group at each follow-up within 1 year (P < .05), but the difference was not significant at 2- and 3-year follow-up (P > .05). There was no significant difference in mortality among the three groups at each follow-up point (P > .05). The nonunion rate was 11.76% (6/51) in CST group and 9.80% (5/51) in IF group and showed no significant difference (P > .05).
CONCLUSION


CST may be a feasible way for IFNF in the older patients.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04219943.",2020,There was no significant difference in mortality among the three groups at each follow-up point (P > .05).,"['A total of 154 patients with IFNF aged between 75 and 97\u2009years', 'older patients', 'Nanjing First Hospital, Nanjing Medical University, Nanjing, China', 'Patients 75\u2009Years and Older', 'patients older than 75\u2009years with impacted femoral neck fracture (IFNF', 'IFNF patients older than 75\u2009years with a 1:1:1 ratio']","['conservative treatment (CST), internal fixation (IF), and hemiarthroplasty (HA', 'CST', 'Conservative vs Surgical Treatment of Impacted Femoral Neck Fracture']","['safety and effectiveness', 'HHS', 'Harris hip score (HHS) (primary outcome) for hip function, European Quality of Life-5 Dimensions (EQ-5D) index scores for health-related quality of life, and visual analogue scale score for hip pain', 'operative duration', 'EQ-5D index score', 'mortality', 'nonunion rate', 'Operation duration, blood loss, mortality, union rate, complications, and reoperation', 'blood loss']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0019559', 'cui_str': 'Hip pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}]",154.0,0.0456269,There was no significant difference in mortality among the three groups at each follow-up point (P > .05).,"[{'ForeName': 'Peiran', 'Initials': 'P', 'LastName': 'Wei', 'Affiliation': 'Department of Orthopaedics, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedics, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Department of Orthopaedics, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Geng', 'Affiliation': 'Department of Orthopaedics, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Qingqiang', 'Initials': 'Q', 'LastName': 'Yao', 'Affiliation': 'Department of Orthopaedics, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16535']
1571,32413508,Antimicrobial Photodynamic Therapy with Diode laser and Methylene blue as an adjunct to scaling and root planning: A clinical trial.,"INTRODUCTION


Chronic periodontitis, the most common periodontal disease, is the destruction of tooth supporting structures and alveolar bone which may result in teeth exfoliation. Conventionally, the treatment aims at decreasing bacterial load by mechanical debridement and systemic or local delivery of antibiotics. Antimicrobial photodynamic therapy (aPDT) is a safe alternative adjunct therapy for elimination of pathogenic bacteria in periodontal pocket. The aim of this study was to evaluate the effect of aPDT with 660 nm diode laser and methylene blue as an adjunct to SRP on clinical periodontal parameters.
MATERIALS AND METHODS


In this clinical trial, we assessed aPDT as an adjunct to scaling and root planning (SRP) in chronic periodontitis treatment. A total of 50 subjected were enrolled. The case group received SRP and aPDT with methylene blue solution as photosensitizer and diode laser (wavelength=660 nm, power = 150 mW) irradiation. The control group received only SRP. The effect on clinical parameters, namely Plaque index (PI), Gingival index (GI), and probing depth (PD) was recorded at baseline and 6 weeks, 3 months and 6 months.
RESULTS


There were no significant differences between participants for clinical parameters at baseline. PI, GI and PD significantly improved compared to baseline (P < 0.05).
CONCLUSION


It can be concluded that aPDT can be considered a safe and efficient measure in addition to SRP because it can improve clinical outcomes with no adverse effects.",2020,Antimicrobial photodynamic therapy (aPDT) is a safe alternative adjunct therapy for elimination of pathogenic bacteria in periodontal pocket.,"['A total of 50 subjected were enrolled', 'chronic periodontitis treatment']","['SRP', 'aPDT with 660\u2009nm diode laser and methylene blue', 'SRP and aPDT with methylene blue solution as photosensitizer and diode laser (wavelength=660\u2009nm, power\u2009=\u2009150\u2009mW) irradiation', 'aPDT', 'Antimicrobial photodynamic therapy (aPDT', 'Antimicrobial Photodynamic Therapy with Diode laser and Methylene blue', 'scaling and root planning (SRP']","['clinical parameters, namely Plaque index (PI), Gingival index (GI), and probing depth (PD', 'PI, GI and PD']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0162713', 'cui_str': 'Photosensitizing agent'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",50.0,0.0478309,Antimicrobial photodynamic therapy (aPDT) is a safe alternative adjunct therapy for elimination of pathogenic bacteria in periodontal pocket.,"[{'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Derikvand', 'Affiliation': 'Department of periodontics faculty of dentisty, Borujerd Branch, Islamic Azad University, Borujerd, Iran.'}, {'ForeName': 'Seyedeh Sara', 'Initials': 'SS', 'LastName': 'Ghasemi', 'Affiliation': 'Dentist, Hygiene Department of Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Hannaneh', 'Initials': 'H', 'LastName': 'Safiaghdam', 'Affiliation': ""Students' research committee, Dental school, Shahid Beheshti University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Piriaei', 'Affiliation': 'Department of Mathematics, Borujerd Branch, Islamic Azad University, Borujerd, Iran.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Chiniforush', 'Affiliation': 'Dental Implant Research Center, Dentistry Research Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: n-chiniforush@farabi.tums.ac.ir.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101818']
1572,32413581,Trauma-related cognitions predict treatment response in smokers with PTSD: Evidence from cross-lagged panel analyses.,"OBJECTIVE


Compared to smokers without posttraumatic stress disorders (PTSD), smokers with PTSD smoke more heavily and are less successful in quitting smoking. However, limited research has examined the cognitive pathways underlying this heightened comorbidity. The current study is the first to simultaneously model the cross-sectional and lagged relationships between trauma-related cognitions and cigarette smoking, as well as between trauma-related cognitions and PTSD severity, in smokers with comorbid PTSD receiving treatment.
METHOD


Participants (n = 142) were seeking treatment for smoking cessation and PTSD as part of a randomized controlled trial of varenicline and smoking cessation counseling with or without adjunctive Prolonged Exposure (varenicline + PE vs. varenicline only) (Foa et al., 2017). Data were available for both baseline and end-of-treatment assessments of trauma cognitions severity of cigarette smoking and PTSD symptoms. We conducted both cross-sectional and lagged analysis to simultaneously examine the bidirectional relationship from trauma cognitions and 1) cigarette smoking and 2) PTSD symptoms.
RESULTS


Trauma cognitions (specifically, negative beliefs about the self and the world) were significantly associated with cigarette/day at the end of treatment for participants who received varenicline only. However, baseline trauma cognitions did not predict post-treatment cigarettes/day. Baseline trauma cognitions (specifically negative beliefs about the self and world) were associated with PTSD severity at both baseline and end of treatment; furthermore, these negative cognitions at baseline positively and prospectively predicted end-of-treatment PTSD severity, but not vice versa. Wald tests revealed that there were no treatment effects on these cross-lagged relationships. Conclusions These findings provide novel empirical support for the importance of addressing trauma-related cognitions in the smoking cessation treatment efforts for patients with comorbid PTSD and cigarette smoking.",2020,"RESULTS


Trauma cognitions (specifically, negative beliefs about the self and the world) were significantly associated with cigarette/day at the end of treatment for participants who received varenicline only.","['smokers with PTSD', 'patients with comorbid PTSD and cigarette smoking', 'smokers without posttraumatic stress disorders (PTSD), smokers with PTSD smoke', 'Participants (n\u202f=\u202f142) were', 'smokers with comorbid PTSD receiving treatment']","['varenicline and smoking cessation counseling with or without adjunctive Prolonged Exposure (varenicline\u202f+\u202fPE vs. varenicline only', 'varenicline', 'seeking treatment for smoking cessation and PTSD']","['Baseline trauma cognitions', 'baseline trauma cognitions', 'PTSD severity', 'trauma cognitions severity of cigarette smoking and PTSD symptoms']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",142.0,0.00981447,"RESULTS


Trauma cognitions (specifically, negative beliefs about the self and the world) were significantly associated with cigarette/day at the end of treatment for participants who received varenicline only.","[{'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Mu', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States. Electronic address: wenting.mu@pennmedicine.upenn.edu.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Narine', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Farris', 'Affiliation': 'Department of Psychology, Rutgers University, The State University of New Jersey, United States.'}, {'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Lieblich', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Yinyin', 'Initials': 'Y', 'LastName': 'Zang', 'Affiliation': 'School of Psychological and Cognitive Sciences, Peking University, Beijing, China.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Bredemeier', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Edna', 'Initials': 'E', 'LastName': 'Foa', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106376']
1573,31570124,Impact of a mindfulness-based intervention on undergraduate pharmacy students' stress and distress: Quantitative results of a mixed-methods study.,"INTRODUCTION


Stress negatively impacts upon physical and mental health. Pharmacy students demonstrate higher stress than the general population. Mindfulness may improve pharmacy students' stress and distress levels. The purpose of this study was to assess the quantitative effects of a mindfulness-based intervention on pharmacy student stress, distress, burnout, and mindfulness levels.
METHODS


A quasi-randomised controlled trial was conducted at an Irish pharmacy school during the 2016 to 2017 academic year. The intervention group completed a four-week mindfulness course. The waitlist control group received only usual education. Participants completed a demographics form, the Perceived Stress Scale, the General Health Questionnaire, the Maslach Burnout Inventory Student Survey, and the Five Facet Mindfulness Questionnaire at baseline and immediately post-intervention.
RESULTS


Full data were gathered and analysed for 99 students (51 intervention, 48 control, 66.7% female). There were no significant differences between the intervention and control groups at baseline. Post-intervention, a large effect on mental distress was found (Partial Eta Squared 0.137) with the intervention group reporting statistically significantly lower distress than the control group (F (1,98) = 15.3, p < 0.005). Stress and distress were significantly improved for females (p = 0.026, p < 0.005), while males improved in the observing facet of mindfulness (p = 0.038). There was a positive association between attendance and these findings (r2 = 0.191, p < 0.005).
CONCLUSION


Female pharmacy students experienced improvements in mental distress and stress after participation in the intervention. Mindfulness may have a future role to play in pharmacy and healthcare education.",2019,"Stress and distress were significantly improved for females (p = 0.026, p < 0.005), while males improved in the observing facet of mindfulness (p = 0.038).","['99 students (51 intervention, 48 control, 66.7% female', 'A quasi-randomised controlled trial was conducted at an Irish pharmacy school during the 2016 to 2017 academic year', 'Female pharmacy students', ""undergraduate pharmacy students' stress and distress""]","['waitlist control group received only usual education', 'mindfulness-based intervention']","[""pharmacy students' stress and distress levels"", 'Perceived Stress Scale, the General Health Questionnaire, the Maslach Burnout Inventory Student Survey, and the Five Facet Mindfulness Questionnaire', 'mental distress', 'distress', 'pharmacy student stress, distress, burnout, and mindfulness levels', 'observing facet of mindfulness', 'Stress and distress', 'mental distress and stress']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517843', 'cui_str': '66.7 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0422794', 'cui_str': 'Irish (NMO) (ethnic group)'}, {'cui': 'C0036381', 'cui_str': 'Schools, Pharmacy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038497', 'cui_str': 'Pharmacy Student'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0038497', 'cui_str': 'Pharmacy Student'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale (assessment scale)'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire (assessment scale)'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0235109', 'cui_str': 'Mental distress (finding)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}]",,0.0222224,"Stress and distress were significantly improved for females (p = 0.026, p < 0.005), while males improved in the observing facet of mindfulness (p = 0.038).","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': ""O'Driscoll"", 'Affiliation': 'Pharmaceutical Care Research Group, School of Pharmacy, University College Cork, Ireland. Electronic address: michelle.odriscoll@ucc.ie.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Sahm', 'Affiliation': 'Pharmaceutical Care Research Group, School of Pharmacy, University College Cork, Ireland; Pharmacy Department, Mercy University Hospital, Cork, Ireland. Electronic address: l.sahm@ucc.ie.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Byrne', 'Affiliation': 'Mindfulness Centre for Professional Training in Ireland, 33 Pembroke Street Lower, Dublin 2, Ireland.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Lambert', 'Affiliation': 'School of Applied Psychology, University College Cork, Ireland. Electronic address: sharon.lambert@ucc.ie.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Byrne', 'Affiliation': 'Pharmaceutical Care Research Group, School of Pharmacy, University College Cork, Ireland. Electronic address: Stephen.byrne@ucc.ie.'}]",Currents in pharmacy teaching & learning,['10.1016/j.cptl.2019.05.014']
1574,32413296,Writing to the Mind's Eye of the Blind.,"The implantation of electrodes on the visual cortex of blind individuals could lead to the restoration of a rudimentary form of sight. In this issue of Cell, Beauchamp et al. use electrical stimulation of the visual cortex to create visual perception of shapes.",2020,The implantation of electrodes on the visual cortex of blind individuals could lead to the restoration of a rudimentary form of sight.,[],[],[],[],[],[],,0.0240986,The implantation of electrodes on the visual cortex of blind individuals could lead to the restoration of a rudimentary form of sight.,"[{'ForeName': 'Pieter R', 'Initials': 'PR', 'LastName': 'Roelfsema', 'Affiliation': 'Department of Vision & Cognition, Netherlands Institute for Neuroscience, Meibergdreef 47, 1105 BA Amsterdam, Netherlands; Department of Integrative Neurophysiology, VU University, De Boelelaan 1085, 1081 HV Amsterdam, Netherlands; Department of Psychiatry, Academic Medical Center, Postbus 22660, 1100 DD Amsterdam, Netherlands. Electronic address: p.roelfsema@nin.knaw.nl.'}]",Cell,['10.1016/j.cell.2020.03.014']
1575,32413383,Cost-effectiveness of adding fluoride varnish to a preventive protocol for early childhood caries in rural children with no access to fluoridated drinking water.,"OBJECTIVES


Evidence of the cost-effectiveness of fluoride varnish in the prevention of caries is not yet fully conclusive. The aim of this study was to assess the incremental cost-effectiveness ratio (ICER) of the community-wide application of fluoride varnish in the prevention of early childhood caries (ECC) in non-fluoridated areas.
MATERIALS AND METHODS


A cost-effectiveness analysis was carried out based on a clinical decision tree from the payer's perspective. The effectiveness and cost of the varnish were determined from a two-year follow-up triple-blind randomized control trial in 275 two- to three-year-old children. Costs and benefits were discounted at 3% per year. Only direct costs were evaluated, expressed in Chilean pesos (CLP) valued in July, 2019 (exchange rate USD = CLP686.06). A univariate deterministic sensitivity analysis was carried out.
RESULTS


Incidence of ECC was 45% for the varnish group and 55.6% for the placebo group with a two-year follow-up. The weighted cost to intervene and treat the consequences of ECC was CLP 67,757 (USD96.76) for the fluoride varnish and CLP 67,738 (USD98.74) for the control group. The ICER was CLP 173 (USD0.25) for each extra healthy child in favor of fluoride varnish. The sensitivity analysis showed that the increase in caries was the variable which most influenced the ICER.
CONCLUSIONS


The protocol that included fluoride varnish is more effective and less costly in the prevention of ECC in non-fluoridated areas, compared with a placebo.
CLINICAL SIGNIFICANCE


Findings support the application of fluoride varnish as a cost-effective community strategy to prevent ECC in non-fluoridated areas.",2020,"The protocol that included fluoride varnish is more effective and less costly in the prevention of ECC in non-fluoridated areas, compared with a placebo.
","['rural children with no access to fluoridated drinking water', '275 two- to three-year-old children', 'early childhood caries (ECC) in non-fluoridated areas']","['fluoride varnish', 'placebo']","['Cost-effectiveness', 'Costs and benefits', 'caries', 'incremental cost-effectiveness ratio (ICER', 'Incidence of ECC']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010187', 'cui_str': 'Benefits and Costs'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}]",,0.119731,"The protocol that included fluoride varnish is more effective and less costly in the prevention of ECC in non-fluoridated areas, compared with a placebo.
","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Zaror', 'Affiliation': 'Department of Pediatric Dentistry and Orthodontics, Faculty of Dentistry, Universidad de La Frontera, Temuco, Chile; Center for Research in Epidemiology, Economics and Oral Public Health (CIEESPO), Faculty of Dentistry, Universidad de La Frontera, Temuco, Chile. Electronic address: carlos.zaror@ufrontera.cl.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Muñoz-Millán', 'Affiliation': 'Department of Pediatric Dentistry and Orthodontics, Faculty of Dentistry, Universidad de La Frontera, Temuco, Chile; Center for Research in Epidemiology, Economics and Oral Public Health (CIEESPO), Faculty of Dentistry, Universidad de La Frontera, Temuco, Chile; Universitat Autònoma de Barcelona, Barcelona, Spain. Electronic address: patricia.munoz@ufrontera.cl.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Espinoza-Espinoza', 'Affiliation': 'Center for Research in Epidemiology, Economics and Oral Public Health (CIEESPO), Faculty of Dentistry, Universidad de La Frontera, Temuco, Chile; Department of Public Health, Faculty of Medicine, Universidad de La Frontera, Temuco, Chile. Electronic address: gerardo.espinoza@ufrontera.cl.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Vergara-González', 'Affiliation': 'Aysén Health Service, Coyhaique, Chile. Electronic address: carovergarag@gmail.com.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Martínez-Zapata', 'Affiliation': 'Iberoamerican Cochrane Centre, Biomedical Research Institute Sant Pau (IIB Sant Pau); CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain. Electronic address: MMartinezz@santpau.cat.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103374']
1576,32413933,Adalimumab for maintenance of remission in Crohn's disease.,"BACKGROUND


Conventional medications for Crohn's disease (CD) include anti-inflammatory drugs, immunosuppressants and corticosteroids. If an individual does not respond, or loses response to first-line treatments, then biologic therapies such as tumour necrosis factor-alpha (TNF-α) antagonists such as adalimumab are considered for treating CD. Maintenance of remission of CD is a clinically important goal, as disease relapse can negatively affect quality of life.
OBJECTIVES


To assess the efficacy and safety of adalimumab for maintenance of remission in people with quiescent CD.
SEARCH METHODS


We searched the Cochrane IBD Group Specialized Register, CENTRAL, MEDLINE, Embase, and clinicaltrials.gov from inception to April 2019.
SELECTION CRITERIA


We considered for inclusion randomized controlled trials (RCTs) comparing adalimumab to placebo or to an active comparator.
DATA COLLECTION AND ANALYSIS


We analyzed data on an intention-to-treat basis. We calculated risk ratios (RRs) and corresponding 95% confidence intervals (95% CI) for dichotomous outcomes. The primary outcome was failure to maintain clinical remission. We define clinical remission as a Crohn's Disease Activity Index (CDAI) score of < 150. Secondary outcomes were failure to maintain clinical response, endoscopic remission, endoscopic response, histological remission and adverse events (AEs). We assessed biases using the Cochrane 'Risk of bias' tool. We used GRADE to assess the overall certainty of evidence supporting the primary outcome.
MAIN RESULTS


We included six RCTs (1158 participants). We rated four trials at low risk of bias and two trials at unclear risk of bias. All participants had moderate-to-severe CD that was in clinical remission. Four studies were placebo-controlled (1012 participants). Two studies (70 participants) compared adalimumab to active medication (azathioprine, mesalamine or 6-mercaptopurine) in participants who had an ileocolic resection prior to study enrolment. Adalimumab versus placebo Fifty-nine per cent (252/430) of participants treated with adalimumab failed to maintain clinical remission at 52 to 56 weeks, compared with 86% (217/253) of participants receiving placebo (RR 0.70, 95% CI 0.64 to 0.77; 3 studies, 683 participants; high-certainty evidence). Among those who received prior TNF-α antagonist therapy, 69% (129/186) of adalimumab participants failed to maintain clinical or endoscopic response at 52 to 56 weeks, compared with 93% (108/116) of participants who received placebo (RR 0.76, 95% CI 0.68 to 0.85; 2 studies, 302 participants; moderate-certainty evidence). Fifty-one per cent (192/374) of participants who received adalimumab failed to maintain clinical remission at 24 to 26 weeks, compared with 79% (149/188) of those who received placebo (RR 0.66, 95% CI 0.52 to 0.83; 2 studies, 554 participants; moderate-certainty evidence). Eighty-seven per cent (561/643) of participants who received adalimumab reported an AE compared with 85% (315/369) of participants who received placebo (RR 1.01, 95% CI 0.94 to 1.09; 4 studies, 1012 participants; high-certainty evidence). Serious adverse events were seen in 8% (52/643) of participants who received adalimumab and 14% (53/369) of participants who received placebo (RR 0.56, 95% CI 0.39 to 0.80; 4 studies, 1012 participants; moderate-certainty evidence) and withdrawal due to AEs was reported in 7% (45/643) of adalimumab participants compared to 13% (48/369) of placebo participants (RR 0.59, 95% CI 0.38 to 0.91; 4 studies, 1012 participants; moderate-certainty evidence). Commonly-reported AEs included CD aggravation, arthralgia, nasopharyngitis, urinary tract infections, headache, nausea, fatigue and abdominal pain. Adalimumab versus active comparators No studies reported failure to maintain clinical remission. One study reported on failure to maintain clinical response and endoscopic remission at 104 weeks in ileocolic resection participants who received either adalimumab, azathioprine or mesalamine as post-surgical maintenance therapy. Thirteen per cent (2/16) of adalimumab participants failed to maintain clinical response compared with 54% (19/35) of azathioprine or mesalamine participants (RR 0.23, 95% CI 0.06 to 0.87; 51 participants). Six per cent (1/16) of participants who received adalimumab failed to maintain endoscopic remission, compared with 57% (20/35) of participants who received azathioprine or mesalamine (RR 0.11, 95% CI 0.02 to 0.75; 51 participants; very low-certainty evidence). One study reported on failure to maintain endoscopic response at 24 weeks in ileocolic resection participants who received either adalimumab or 6-mercaptopurine (6-MP) as post-surgical maintenance therapy. Nine per cent (1/11) of adalimumab participants failed to maintain endoscopic remission compared with 50% (4/8) of 6-MP participants (RR 0.18, 95% CI 0.02 to 1.33; 19 participants).
AUTHORS' CONCLUSIONS


Adalimumab is an effective therapy for maintenance of clinical remission in people with quiescent CD. Adalimumab is also effective in those who have previously been treated with TNF-α antagonists. The effect of adalimumab in the post-surgical setting is uncertain. More research is needed in people with recent bowel surgery for CD to better determine treatment plans following surgery. Future research should continue to explore factors that influence initial and subsequent biologic selection for people with moderate-to-severe CD. Studies comparing adalimumab to other active medications are needed, to help determine the optimal maintenance therapy for CD.",2020,"Six per cent (1/16) of participants who received adalimumab failed to maintain endoscopic remission, compared with 57% (20/35) of participants who received azathioprine or mesalamine (RR 0.11, 95% CI 0.02 to 0.75; 51 participants; very low-certainty evidence).","['people with moderate-to-severe CD', ""Crohn's disease"", 'people with quiescent CD', 'participants who had an ileocolic resection prior to study enrolment']","['adalimumab to placebo', 'azathioprine', 'adalimumab', '6-MP', 'adalimumab or 6-mercaptopurine (6-MP', 'TNF-α antagonist therapy', 'adalimumab, azathioprine or mesalamine', 'azathioprine or mesalamine', 'mesalamine', 'Adalimumab', 'Adalimumab versus active comparators', 'adalimumab to active medication (azathioprine, mesalamine or 6-mercaptopurine', 'placebo']","['maintain clinical response', 'maintain clinical or endoscopic response', 'maintain endoscopic remission', ""Crohn's Disease Activity Index (CDAI) score"", 'efficacy and safety', 'maintain clinical remission', 'moderate-certainty evidence) and withdrawal due to AEs', 'failure to maintain clinical response, endoscopic remission, endoscopic response, histological remission and adverse events (AEs', 'CD aggravation, arthralgia, nasopharyngitis, urinary tract infections, headache, nausea, fatigue and abdominal pain', 'failure to maintain clinical remission', 'calculated risk ratios (RRs', 'Serious adverse events']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C1280902', 'cui_str': 'Ileocolic resection'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0451071', 'cui_str': ""Crohn's disease activity index""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",,0.562927,"Six per cent (1/16) of participants who received adalimumab failed to maintain endoscopic remission, compared with 57% (20/35) of participants who received azathioprine or mesalamine (RR 0.11, 95% CI 0.02 to 0.75; 51 participants; very low-certainty evidence).","[{'ForeName': 'Cassandra M', 'Initials': 'CM', 'LastName': 'Townsend', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}, {'ForeName': 'Tran M', 'Initials': 'TM', 'LastName': 'Nguyen', 'Affiliation': 'Robarts Clinical Trials, London, Canada.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Cepek', 'Affiliation': 'Schulich School of Medicine & Dentistry, University of Western Ontario, London, Canada.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Abbass', 'Affiliation': 'Schulich School of Medicine & Dentistry, University of Western Ontario, London, Canada.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Parker', 'Affiliation': 'Robarts Clinical Trials, London, Canada.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'MacDonald', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Khanna', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}, {'ForeName': 'Vipul', 'Initials': 'V', 'LastName': 'Jairath', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012877.pub2']
1577,31859677,Perceptions and Experiences of Women Participating in a Digital Technology-Based Physical Activity Intervention (the mPED Trial): Qualitative Study.,"BACKGROUND


Despite the benefits of regular physical activity, women in every age group have lower activity levels than men, and few women meet the recommended levels of physical activity. Digital technologies have been useful in increasing physical activity during the course of an interventional study. However, sustaining that activity once the clinical trial was complete was a major challenge.
OBJECTIVE


This study aimed to describe the experiences and perspectives of physically inactive women who completed the mobile phone-based physical activity education (mPED), a randomized controlled trial, at 12 months.
METHODS


Of 210 women who were enrolled in the mPED trial, 203 completed a 12-month open-ended exit interview and survey through phone. The participants were asked about their physical activity levels; their digital technology use; what they learned from, liked, and would change about the trial; their motivations to keep active post-trial; and their advice for other women. Interviews were transcribed verbatim and thematically analyzed using the brief survey qualitative description. Descriptive statistics were used to describe the survey data with the significance level set at P<.05.
RESULTS


In the 12-month survey, a greater proportion of the participants in the intervention group, compared with the control group, reported that they regularly wore a pedometer or physical activity tracker (49.3%, 66/143 vs 26.1%, 18/69; P=.002) and engaged in brisk walking (54.5%, 73/134 vs 30.4%, 21/69; P=.001). The experiences and perceptions of physical activity of physically inactive women over time were embedded in a complex interplay of internal and external factors. A total of 6 interactive themes emerged as critical in supporting continued engagement in physical activity postintervention: tracking, technology versus personal touch, accountability, resources and environment, motivation, and habit formation. Technology allowed for self-tracking, which supported internal accountability. However, tracking by another person (personal touch) was needed for external accountability. Resources and environment underpinned the relationship among the themes of tracking, technology versus personal touch, accountability, motivation, and habit formation.
CONCLUSIONS


Future research is needed to identify the best ways to harness this dynamic process in promoting and sustaining physical activity among inactive women. Digital technology is evolving at an exponential rate and provides new opportunities to transform research into new approaches to promote physical activity.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01280812; https://clinicaltrials.gov/ct2/show/NCT01280812.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1186/1471-2485-11-933.",2019,"In the 12-month survey, a greater proportion of the participants in the intervention group, compared with the control group, reported that they regularly wore a pedometer or physical activity tracker (49.3%, 66/143 vs 26.1%, 18/69; P=.002) and engaged in brisk walking (54.5%, 73/134 vs 30.4%, 21/69; P=.001).","['physically inactive women who completed the', 'Of 210 women who were enrolled in the mPED trial, 203 completed a 12-month open-ended exit interview and survey through phone']","['mobile phone-based physical activity education (mPED', 'Digital Technology-Based Physical Activity Intervention']","['pedometer or physical activity tracker', 'physical activity postintervention: tracking, technology versus personal touch, accountability, resources and environment, motivation, and habit formation', 'physical activity', 'brisk walking']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0337094', 'cui_str': 'Exit (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0078889', 'cui_str': 'Accountability'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0443162', 'cui_str': 'Brisk (qualifier value)'}]",203.0,0.0666894,"In the 12-month survey, a greater proportion of the participants in the intervention group, compared with the control group, reported that they regularly wore a pedometer or physical activity tracker (49.3%, 66/143 vs 26.1%, 18/69; P=.002) and engaged in brisk walking (54.5%, 73/134 vs 30.4%, 21/69; P=.001).","[{'ForeName': 'Teri', 'Initials': 'T', 'LastName': 'Lindgren', 'Affiliation': 'School of Nursing, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hooper', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, United States.'}, {'ForeName': 'Yoshimi', 'Initials': 'Y', 'LastName': 'Fukuoka', 'Affiliation': 'Physiological Nursing, Univesity of California, San Francisco, San Francisco, CA, United States.'}]",JMIR public health and surveillance,['10.2196/13570']
1578,32413238,Pharmacokinetics and Bioequivalence of 2 Olanzapine Orally Disintegrating Tablet Products in Healthy Chinese Subjects Under Fed and Fasting Conditions.,"To assess the bioequivalence of two 5-mg olanzapine orally disintegrating tablet (ODT) products, 2 randomized, open-label, single-dose, 2-way crossover studies were carried out under fasting or fed conditions. Blood samples were collected at scheduled times according to the study protocol. Statistical analysis of area under the concentration-time curve from time 0 to 168 hours (AUC 0-t  ), area under the curve from time zero to infinity (AUC 0-∞  ), and peak plasma concentration (C max  ) was conducted. Two formulations were considered bioequivalent if the 90% confidence intervals (CIs) of the geometric mean ratios for AUC 0-t,  AUC 0-∞  , and C max  were within the range of 0.80-1.25. Adverse events were recorded and evaluated throughout the studies. A total of 48 subjects with 24 in each study completed the 2 studies. In fasted subjects, the 90%CIs for the test product versus the reference product were 97.28%-105.13% for AUC 0-t  , 97.57%-105.54% for AUC 0-∞  , and 90.94%-103.97% for C max  . In fed subjects, the 90%CIs for AUC 0-t  , AUC 0-∞  and C max  were 99.73%-122.63%, 99.56%-121.75%, and 99.46%-120.46%, respectively. No serious adverse events were reported in the studies. The reference and the test product of 5-mg olanzapine ODT show comparable pharmacokinetic profiles under both fed and fasted conditions and were considered bioequivalent.",2020,No serious adverse events were reported in the studies.,"['48 subjects with 24 in each study completed the 2 studies', 'Healthy Chinese Subjects Under Fed and Fasting Conditions']","['olanzapine', 'Olanzapine Orally Disintegrating Tablet Products', 'olanzapine ODT']","['serious adverse events', 'peak plasma concentration', '90%CIs for AUC 0-t  , AUC 0-∞  and C max', 'Adverse events']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C1248714', 'cui_str': 'olanzapine Disintegrating Oral Tablet'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",48.0,0.0358422,No serious adverse events were reported in the studies.,"[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Department of Clinical Pharmacology Lab, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Lizhi', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'QILU Pharmaceutical, Jinan, Shandong, China.'}, {'ForeName': 'Hongquan', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Clinical Pharmacology Lab, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Junlin', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Department of Clinical Pharmacology Lab, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yunfang', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Clinical Pharmacology Lab, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Jianghui', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical Pharmacology Lab, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': 'Department of Clinical Pharmacology Lab, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.765']
1579,32413250,Implementing Active Support in disability day services: A 6-month prospective study on engagement and behaviours of concern among adults with intellectual disability.,"BACKGROUND


Adults with intellectual disability are often disengaged in disability services. While Active Support has found efficacy in residential settings, less is known in day services. This study examines the impact of Active Support in day services for adults with intellectual disability in Singapore, particularly on engagement and behaviours of concern.
METHOD


An experimental design was used, with a group of 32 participants receiving an Active Support programme over 6 months, compared to a control group of 16 participants with treatment as usual. Time sampling of behaviours was conducted every 4 weeks.
RESULTS


The Active Support group saw increases in activity engagement and social engagement with staff, and decreases in disengagement and stereotypical behaviours, compared to the control group over time.
CONCLUSION


Results support the implementation of Active Support across other day services for adults with intellectual disability. Active Support principles should be considered in planning policies and service outcome measures.",2020,"The Active Support group saw increases in activity engagement and social engagement with staff, and decreases in disengagement and stereotypical behaviours, compared to the control group over time.
","['adults with intellectual disability in Singapore, particularly on engagement and behaviours of concern', '32 participants receiving an', 'Adults with intellectual disability', 'adults with intellectual disability']",['Active Support programme'],"['activity engagement and social engagement with staff, and decreases in disengagement and stereotypical behaviours']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",16.0,0.0621839,"The Active Support group saw increases in activity engagement and social engagement with staff, and decreases in disengagement and stereotypical behaviours, compared to the control group over time.
","[{'ForeName': 'Jiayong', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'MINDS, Singapore.'}, {'ForeName': 'Vimallan', 'Initials': 'V', 'LastName': 'Manokara', 'Affiliation': 'MINDS, Singapore.'}, {'ForeName': 'Jesselyn S', 'Initials': 'JS', 'LastName': 'Ng', 'Affiliation': 'MINDS, Singapore.'}, {'ForeName': 'Sivananda', 'Initials': 'S', 'LastName': 'Penchaliah', 'Affiliation': 'MINDS, Singapore.'}]",Journal of applied research in intellectual disabilities : JARID,['10.1111/jar.12750']
1580,32414137,Alcohol Hangover Does Not Alter the Application of Model-Based and Model-Free Learning Strategies.,"Frequent alcohol binges shift behavior from goal-directed to habitual processing modes. This shift in reward-associated learning strategies plays a key role in the development and maintenance of alcohol use disorders and seems to persist during (early stages of) sobriety in at-risk drinkers. Yet still, it has remained unclear whether this phenomenon might be associated with alcohol hangover and thus also be found in social drinkers. In an experimental crossover design,  n  = 25 healthy young male participants performed a two-step decision-making task once sober and once hungover (i.e., when reaching sobriety after consuming 2.6 g of alcohol per estimated liter of total body water). This task allows the separation of effortful model-based and computationally less demanding model-free learning strategies. The experimental induction of alcohol hangover was successful, but we found no significant hangover effects on model-based and model-free learning scores, the balance between model-free and model-based valuation (ω), or perseveration tendencies (π). Bayesian analyses provided positive evidence for the null hypothesis for all measures except π (anecdotal evidence for the null hypothesis). Taken together, alcohol hangover, which results from a single binge drinking episode, does not impair the application of effortful and computationally costly model-based learning strategies and/or increase model-free learning strategies. This supports the notion that the behavioral deficits observed in at-risk drinkers are most likely not caused by the immediate aftereffects of individual binge drinking events.",2020,Bayesian analyses provided positive evidence for the null hypothesis for all measures except π (anecdotal evidence for the null hypothesis).,['n  = 25 healthy young male participants'],[],[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],[],25.0,0.00984522,Bayesian analyses provided positive evidence for the null hypothesis for all measures except π (anecdotal evidence for the null hypothesis).,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Berghäuser', 'Affiliation': 'Chair of Addiction Research, Institute for Clinical Psychology and Psychotherapy, Faculty of Psychology TU Dresden, Chemnitzer Str. 46, 01062 Dresden, Germany.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Bensmann', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine, TU Dresden, Fetscherstr. 74, 01307 Dresden, Germany.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Zink', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine, TU Dresden, Fetscherstr. 74, 01307 Dresden, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Endrass', 'Affiliation': 'Chair of Addiction Research, Institute for Clinical Psychology and Psychotherapy, Faculty of Psychology TU Dresden, Chemnitzer Str. 46, 01062 Dresden, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Beste', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine, TU Dresden, Fetscherstr. 74, 01307 Dresden, Germany.'}, {'ForeName': 'Ann-Kathrin', 'Initials': 'AK', 'LastName': 'Stock', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine, TU Dresden, Fetscherstr. 74, 01307 Dresden, Germany.'}]",Journal of clinical medicine,['10.3390/jcm9051453']
1581,32414066,Benefits of Adhering to a Mediterranean Diet Supplemented with Extra Virgin Olive Oil and Pistachios in Pregnancy on the Health of Offspring at 2 Years of Age. Results of the San Carlos Gestational Diabetes Mellitus Prevention Study.,"The intrauterine environment may be related to the future development of chronic diseases in the offspring. The St. Carlos gestational diabetes mellitus (GDM) prevention study, is a randomized controlled trial that evaluated the influence of the early (before 12th gestational week) Mediterranean diet (MedDiet) on the onset of GDM and adverse gestational outcomes. Out of 874 women assessed after delivery (440 control group (CG)/434 intervention group (IG)), 703 children were followed (365/338; CG/IG), with the aim to assess whether the adherence to a MedDiet during pregnancy induces health benefits for the offspring during the first two years of life. Logistic regression analysis showed that the IG in children of mothers with pre-gestational body mass index (BMI) < 25 kg/m 2  and normal glucose tolerance (NGT), was associated with a lower risk (RR(95% CI)) of suffering from severe events requiring hospitalization due to bronchiolitis/asthma (0.75(0.58-0.98) and 0.77(0.59-0.99), respectively) or other diseases that required either antibiotic (0.80(0.65-0.98) and 0.80(0.65-0.99), respectively), corticosteroid treatment (0.73(0.59-0.90) and 0.79(0.62-1.00) respectively) or both (all  p  < 0.05). A nutritional intervention based on the MedDiet during pregnancy is associated with a reduction in offspring's hospital admissions, especially in women with pre-gestational BMI < 25 kg/m 2  and NGT.",2020,"A nutritional intervention based on the MedDiet during pregnancy is associated with a reduction in offspring's hospital admissions, especially in women with pre-gestational BMI < 25 kg/m 2  and NGT.","['women with pre-gestational BMI < 25 kg/m 2  and NGT', '874 women assessed after delivery (440 control group (CG)/434 intervention group (IG)), 703 children']","['Mediterranean Diet Supplemented with Extra Virgin Olive Oil and Pistachios', 'Mediterranean diet (MedDiet']",['normal glucose tolerance (NGT'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0459819', 'cui_str': 'Pistachio nut'}]","[{'cui': 'C0860800', 'cui_str': 'Glucose normal'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",874.0,0.0489339,"A nutritional intervention based on the MedDiet during pregnancy is associated with a reduction in offspring's hospital admissions, especially in women with pre-gestational BMI < 25 kg/m 2  and NGT.","[{'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Melero', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Assaf-Balut', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Nuria García de la', 'Initials': 'NG', 'LastName': 'Torre', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Inés', 'Initials': 'I', 'LastName': 'Jiménez', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Bordiú', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Laura Del', 'Initials': 'LD', 'LastName': 'Valle', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Valerio', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Familiar', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Durán', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Runkle', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'María Paz de', 'Initials': 'MP', 'LastName': 'Miguel', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Montañez', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Barabash', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Martín', 'Initials': 'M', 'LastName': 'Cuesta', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Herraiz', 'Affiliation': 'Facultad de Medicina. Medicina II Department, Universidad Complutense de Madrid, 28040, Madrid, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Izquierdo', 'Affiliation': 'Facultad de Medicina. Medicina II Department, Universidad Complutense de Madrid, 28040, Madrid, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Rubio', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Alfonso L', 'Initials': 'AL', 'LastName': 'Calle-Pascual', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9051454']
1582,32414338,Ultrasound in managing extrapulmonary tuberculosis: a randomized controlled two-center study.,"BACKGROUND


Patients with clinically suspected tuberculosis are often treated empirically, as diagnosis - especially of extrapulmonary tuberculosis - remains challenging. This leads to an overtreatment of tuberculosis and to underdiagnosis of possible differential diagnoses.
METHODS


This open-label, parallel-group, superiority randomized controlled trial is done in a rural and an urban center in Tanzania. HIV-positive and -negative adults (≥18 years) with clinically suspected extrapulmonary tuberculosis are randomized in a 1:1 ratio to an intervention- or control group, stratified by center and HIV status. The intervention consists of a management algorithm including extended focused assessment of sonography for HIV and tuberculosis (eFASH) in combination with chest X-ray and microbiological tests. Treatment with anti-tuberculosis drugs is started, if eFASH is positive, chest X-ray suggests tuberculosis, or a microbiological result is positive for tuberculosis. Patients in the control group are managed according national guidelines. Treatment is started if microbiology is positive or empirically according to the treating physician. The primary outcome is the proportion of correctly managed patients at 6 months (i.e patients who were treated with anti-tuberculosis treatment and had definite or probable tuberculosis, and patients who were not treated with anti-tuberculosis treatment and did not have tuberculosis). Secondary outcomes are the proportion of symptom-free patients at two and 6 months, and time to death. The sample size is 650 patients.
DISCUSSION


This study will determine, whether ultrasound in combination with other tests can increase the proportion of correctly managed patients with clinically suspected extrapulmonary tuberculosis, thus reducing overtreatment with anti-tuberculosis drugs.
TRIAL REGISTRATION


PACTR, Registration number: PACTR201712002829221, registered December 1st 2017.",2020,"This study will determine, whether ultrasound in combination with other tests can increase the proportion of correctly managed patients with clinically suspected extrapulmonary tuberculosis, thus reducing overtreatment with anti-tuberculosis drugs.
","['correctly managed patients with clinically suspected extrapulmonary tuberculosis', 'rural and an urban center in Tanzania', 'managing extrapulmonary tuberculosis', 'patients who were treated with anti-tuberculosis treatment and had definite or probable tuberculosis, and patients who were not treated with anti-tuberculosis treatment and did not have tuberculosis', 'Patients with clinically suspected tuberculosis', '650 patients', 'HIV-positive and -negative adults (≥18\u2009years) with clinically suspected extrapulmonary tuberculosis']","['management algorithm including extended focused assessment of sonography for HIV and tuberculosis (eFASH) in combination with chest X-ray and microbiological tests', 'intervention- or control']","['proportion of symptom-free patients at two and 6\xa0months, and time to death']","[{'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0679362', 'cui_str': 'Tuberculosis, extrapulmonary'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0436342', 'cui_str': 'Free of symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.184641,"This study will determine, whether ultrasound in combination with other tests can increase the proportion of correctly managed patients with clinically suspected extrapulmonary tuberculosis, thus reducing overtreatment with anti-tuberculosis drugs.
","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ndege', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania. rndege@ihi.or.tz.'}, {'ForeName': 'Omary', 'Initials': 'O', 'LastName': 'Ngome', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'Farida', 'Initials': 'F', 'LastName': 'Bani', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'Yvan', 'Initials': 'Y', 'LastName': 'Temba', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'Herieth', 'Initials': 'H', 'LastName': 'Wilson', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Vanobberghen', 'Affiliation': 'Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Hella', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'Winfrid', 'Initials': 'W', 'LastName': 'Gingo', 'Affiliation': 'St Francis Referral Hospital, Ifakara, United Republic of Tanzania.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Sasamalo', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'Dorcas', 'Initials': 'D', 'LastName': 'Mnzava', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'Namvua', 'Initials': 'N', 'LastName': 'Kimera', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hiza', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wigayi', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'Herry', 'Initials': 'H', 'LastName': 'Mapesi', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'Irene B', 'Initials': 'IB', 'LastName': 'Kato', 'Affiliation': 'Mwananyamala Regional Referral Hospital, Dar es salaam, United Republic of Tanzania.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Mhimbira', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Reither', 'Affiliation': 'Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Battegay', 'Affiliation': 'Faculty of Medicine, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Paris', 'Affiliation': 'Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Weisser', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rohacek', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania. mrohacek@ihi.or.tz.'}]",BMC infectious diseases,['10.1186/s12879-020-05073-9']
1583,32414298,Adjusting for adherence in randomized trials when adherence is measured as a continuous variable: An application to the Lipid Research Clinics Coronary Primary Prevention Trial.,"BACKGROUND


Clinicians and patients may be more interested in per-protocol effect estimates than intention-to-treat effect estimates from randomized trials. However, per-protocol effect estimates may be biased due to insufficient adjustment for prognostic factors that predict adherence. Adjustment for this bias is possible when appropriate methods, such as inverse probability weighting, are used. But, when adherence is measured as a continuous variable, constructing these weights can be challenging.
METHODS


In the placebo arm of the Lipid Research Clinics Coronary Primary Prevention Trial, we estimated the 7-year cumulative incidence of coronary heart disease under 100% adherence and 0% adherence to placebo. We used dose-response discrete-hazards models with inverse probability weighting to adjust for pre- and post-randomization covariates. We considered several continuous distributions for constructing the inverse probability weights.
RESULTS


The risk difference estimate for 100% adherence compared with 0% adherence ranged from -7.7 to -6.1 percentage points without adjustment for baseline and post-baseline covariates, and ranged from -1.8 to 2.2 percentage points with adjustment using inverse probability weights, depending on the dose-response model and inverse probability weight distribution used.
CONCLUSIONS


Methods which appropriately adjust for time-varying post-randomization variables can explain away much of the bias in the ""effect"" of adherence to placebo. When considering continuous adherence, investigators should consider several models as estimates may be sensitive to the model chosen.",2020,"The risk difference estimate for 100% adherence compared with 0% adherence ranged from -7.7 to -6.1 percentage points without adjustment for baseline and post-baseline covariates, and ranged from -1.8 to 2.2 percentage points with adjustment using inverse probability weights, depending on the dose-response model and inverse probability weight distribution used.
",[],['placebo'],['7-year cumulative incidence of coronary heart disease'],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]",,0.414986,"The risk difference estimate for 100% adherence compared with 0% adherence ranged from -7.7 to -6.1 percentage points without adjustment for baseline and post-baseline covariates, and ranged from -1.8 to 2.2 percentage points with adjustment using inverse probability weights, depending on the dose-response model and inverse probability weight distribution used.
","[{'ForeName': 'Kerollos Nashat', 'Initials': 'KN', 'LastName': 'Wanis', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Arin L', 'Initials': 'AL', 'LastName': 'Madenci', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Hernán', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Eleanor J', 'Initials': 'EJ', 'LastName': 'Murray', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520920893']
1584,31618678,"Antibiotic treatment for 6 days versus 12 days in patients with severe cellulitis: a multicentre randomized, double-blind, placebo-controlled, non-inferiority trial.","OBJECTIVES


To investigate whether antibiotic treatment of 6 days' duration is non-inferior to treatment for 12 days in patients hospitalized for cellulitis.
METHODS


This multicentre, randomized, double-blind, placebo-controlled, non-inferiority trial enrolled adult patients hospitalized for severe cellulitis who were treated with intravenous flucloxacillin. At day 6 participants with symptom improvement who were afebrile were randomized between an additional 6 days of oral flucloxacillin or placebo in a 1:1 ratio, stratified for diabetes and hospital. The primary outcome was cure by day 14, without relapse by day 28. Secondary outcomes included a modified cure assessment and relapse rate by day 90.
RESULTS


Between August 2014 and June 2017, 151 of 248 included participants were randomized. The intention-to-treat population consisted of 76 and 73 participants allocated to 12 and 6 days of antibiotic therapy, respectively (mean age 62 years, 67% males, 24% diabetics); 38/76 (50.0%) and 36/73 (49.3%) were cured in the 12- and 6-day groups respectively (ARR 0.7 percentage points, 95%CI: -15.0 to 16.3). Cure rates were 56/76 (73.7%) and 49/73 (67.1%) with the modified cure assessment (ARR 6.6, 95%CI: -8.0 to 20.8). After initial cure without relapse, day 90 relapse rates were higher in the 6-day group (6% versus 24%, p < 0.05).
CONCLUSIONS


Given the wide confidence intervals, we can neither confirm nor refute our hypothesis that 6 days of therapy is non-inferior to 12 days of therapy. However, a 6-day course resulted in significantly more frequent relapses by day 90. These findings require confirmation in future studies.",2020,"Cure rates were 56/76 (73.7%) and 49/73 (67.1%) with the modified cure assessment (ARR 6.6, 95% CI: -8.0 to 20.8).","['patients with severe cellulitis', 'At day 6 participants with symptom improvement who were afebrile', 'patients hospitalised for cellulitis', '73 participants allocated to 12 and 6\xa0days antibiotic therapy, respectively (mean age 62\xa0years, 67% males, 24% diabetics', 'Between August 2014 and June 2017, 151 of 248 included participants were randomised', 'non-inferiority trial enrolled adult patients hospitalised for severe cellulitis who were treated with']","['placebo', 'intravenous flucloxacillin', 'Antibiotic treatment', 'oral flucloxacillin or placebo']","['frequent relapses', 'modified cure assessment and relapse rate by day 90', 'relapse rates', 'Cure rates', 'cure by day 14, without relapse']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0277797', 'cui_str': 'Apyrexial'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4505128', 'cui_str': 'Noninferiority Trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0016267', 'cui_str': 'flucloxacillin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.750223,"Cure rates were 56/76 (73.7%) and 49/73 (67.1%) with the modified cure assessment (ARR 6.6, 95% CI: -8.0 to 20.8).","[{'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Cranendonk', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Medicine, Division of Infectious Diseases, Amsterdam, the Netherlands; Amsterdam UMC, University of Amsterdam, Centre for Experimental and Molecular Medicine, Amsterdam Infection & Immunity Institute, Amsterdam, the Netherlands. Electronic address: d.r.cranendonk@amc.uva.nl.'}, {'ForeName': 'B C', 'Initials': 'BC', 'LastName': 'Opmeer', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Clinical Research Unit, Amsterdam, the Netherlands.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'van Agtmael', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Internal Medicine, Amsterdam, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Branger', 'Affiliation': 'Department of Internal Medicine, Flevoziekenhuis, Almere, the Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Brinkman', 'Affiliation': 'Department of Internal Medicine, OLVG-Oost, Amsterdam, the Netherlands.'}, {'ForeName': 'A I M', 'Initials': 'AIM', 'LastName': 'Hoepelman', 'Affiliation': 'Department of Internal Medicine, University Medical Centre, University of Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'F N', 'Initials': 'FN', 'LastName': 'Lauw', 'Affiliation': 'Department of Internal Medicine, MC Slotervaart, Amsterdam, the Netherlands.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Oosterheert', 'Affiliation': 'Department of Internal Medicine, University Medical Centre, University of Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Pijlman', 'Affiliation': 'Department of Internal Medicine, St Antonius Ziekenhuis, Utrecht, the Netherlands.'}, {'ForeName': 'S U C', 'Initials': 'SUC', 'LastName': 'Sankatsing', 'Affiliation': 'Department of Internal Medicine, Diakonessenhuis, Utrecht, the Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Soetekouw', 'Affiliation': 'Department of Internal Medicine, Spaarne Gasthuis, Haarlem, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Veenstra', 'Affiliation': 'Department of Internal Medicine, OLVG-West, Amsterdam, the Netherlands.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'de Vries', 'Affiliation': 'Department of Internal Medicine, Tergooiziekenhuizen, Hilversum, the Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Prins', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Medicine, Division of Infectious Diseases, Amsterdam, the Netherlands.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Wiersinga', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Medicine, Division of Infectious Diseases, Amsterdam, the Netherlands; Amsterdam UMC, University of Amsterdam, Centre for Experimental and Molecular Medicine, Amsterdam Infection & Immunity Institute, Amsterdam, the Netherlands.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2019.09.019']
1585,32414185,"ZeOxaNMulti Trial: A Randomized, Double-Blinded, Placebo-Controlled Trial of Oral PMA-zeolite to prevent Chemotherapy-Induced Side Effects, in particular, Peripheral Neuropathy.","Chemotherapy-induced peripheral neuropathy (CIPN) is the most frequently reported adverse effect of oxaliplatin. In this study, we set out to evaluate the role of the panaceo-micro-activation (PMA) zeolite in the reduction of the incidence of CIPN and hematological and liver toxicity. The possible impact of the PMA-zeolite as an adjuvant therapeutic agent is based on its detoxification properties toward agents promoting the development of neuropathy (e.g., ammonium - recognized as a neurotoxic agent produced by tumors), as well as its positive impact on immunity and oxidative stress through its effects in the gastrointestinal tract. From April 2015 to October 2018, a total of 120 patients (pts) diagnosed with predominantly colorectal cancer requiring oxaliplatin-based chemotherapy were randomized to receive either the PMA-zeolite (Multizeo Med) or placebo while undergoing oxaliplatin-based chemotherapy. A nerve-conduction study (NCS)&nbsp;was planned at the baseline, after three and six months of chemotherapy, to evaluate CIPN. Furthermore, the evaluation of hematological and liver toxicity was performed during every cycle of chemotherapy. 70.6% and 64.3% of patients developed CIPN in the placebo and the PMA-zeolite group, respectively. Patients treated with the PMA-zeolite were able to undergo more cycles of chemotherapy (p = 0.03), which also indicates a significant improvement in tolerance to the therapy. The group treated with the PMA-zeolite showed a lower CIPN (although not statistically significant within the whole group of subjects) compared to patients receiving placebo. This advantage was, however, statistically significant in men (p = 0.047). In addition, supplementation with the PMA-zeolite resulted in a lower incidence of severe-grade hematological toxicity (trend toward statistical significance of p = 0.09 was observed). Cancer patients may benefit from the therapy with the appropriate certified zeolite-products (e.g., the PMA-zeolite) for human use in CIPN. The lower CIPN (statistically significant results in the male subgroup) was accompanied by a trend of lower incidence of severe-grade hematological toxicity. Furthermore, these benefits led to a better tolerance toward chemotherapy (increase in cycles) and allow an improved compliance with the oncological treatment protocol.",2020,"Patients treated with the PMA-zeolite were able to undergo more cycles of chemotherapy (p = 0.03), which also indicates a significant improvement in tolerance to the therapy.","['From April 2015 to October 2018, a total of 120 patients (pts) diagnosed with predominantly colorectal cancer requiring', 'Cancer patients']","['PMA-zeolite (Multizeo Med) or placebo while undergoing oxaliplatin-based chemotherapy', 'oxaliplatin', 'Placebo', 'oxaliplatin-based chemotherapy', 'placebo']","['severe-grade hematological toxicity', 'lower CIPN', 'tolerance', 'CIPN', 'hematological and liver toxicity', 'CIPN and hematological and liver toxicity']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0078755', 'cui_str': 'Zeolite'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}]",120.0,0.052801,"Patients treated with the PMA-zeolite were able to undergo more cycles of chemotherapy (p = 0.03), which also indicates a significant improvement in tolerance to the therapy.","[{'ForeName': 'Maria Giuseppa', 'Initials': 'MG', 'LastName': 'Vitale', 'Affiliation': 'Medical Oncology Unit, University Hospital of Modena, 41125 Modena, Italy.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Barbato', 'Affiliation': 'Medical Oncology Unit, AORN Antonio Cardarelli, 80131 Naples, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Crispo', 'Affiliation': 'Epidemiology and Biostatistics Unit, Istituto Nazionale Tumori-IRCCS ""Fondazione G. Pascale"", 80131 Naples, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Habetswallner', 'Affiliation': 'UOC Neurofisiopatologia AORN Cardarelli, 80131 Naples, Italy.'}, {'ForeName': 'Bernardo Maria De', 'Initials': 'BM', 'LastName': 'Martino', 'Affiliation': 'UOC Neurofisiopatologia AORN Cardarelli, 80131 Naples, Italy.'}, {'ForeName': 'Ferdinando', 'Initials': 'F', 'LastName': 'Riccardi', 'Affiliation': 'Medical Oncology Unit, AORN Antonio Cardarelli, 80131 Naples, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Maione', 'Affiliation': 'Medical Oncology Unit, AORN Antonio Cardarelli, 80131 Naples, Italy.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Eisenwagen', 'Affiliation': 'Panaceo International GmbH, 9585 Goedersdorf, Austria.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Vitale', 'Affiliation': 'School of Medicine and Surgery, University of Campania Luigi Vanvitelli, 81100 Caserta, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Cartenì', 'Affiliation': 'Medical Oncology Unit, AORN Antonio Cardarelli, 80131 Naples, Italy.'}]","Molecules (Basel, Switzerland)",['10.3390/molecules25102297']
1586,32414331,"Patient information, communication and competence empowerment in oncology (PIKKO) - evaluation of a supportive care intervention for overall oncological patients. Study protocol of a non-randomized controlled trial.","BACKGROUND


Cancer patients have to undergo a difficult medical therapy and are also confronted with various psychological, social and economic problems. Support is available from many providers, but patients often gain no access to it. Accordingly, there is a need for a single point of contact that can provide advice, information and assistance. In the state of Saarland, Germany, a supportive new consulting and information path (PIKKO) for all types of cancer is currently evaluated by the German Cancer Society, the Cancer Society of the Saarland, three statutory health insurances and the Jena University Hospital. PIKKO is designed to improve quality of life, self-efficacy, health literacy and patient satisfaction and to reduce psychological distress, related health care costs and the days of inability to work. This methodical work presents the process and analysis planning of this evaluation.
METHODS


The study population includes all cancer types, both new and existing diseases. PIKKO (with patient navigator, oncological knowledge database, specialized oncological counseling) is evaluated within a controlled, non-randomized, comparative, multicenter, longitudinal design. In addition to patient surveys, data from statutory health insurances and utilization data from the web database are collected, and interviews with patient navigators and doctors are carried out. Patients are assigned to a control (usual care) or an intervention group (u. c. + PIKKO). Primary outcome is the health related quality of life (SF-12) six months after baseline. Secondary outcomes are self-efficacy (GSE), psychological distress such as depression (PHQ-9) or anxiety (GAD-7), health literacy (HLS-EU-Q47) and patient satisfaction in health care (Qualiskope-A). Furthermore, the time course of direct costs of medical care (e.g. work disability days) and usage data of the intervention modules are analyzed. Among other statistical procedures, we use t-tests, univariate tests and growth curve models.
DISCUSSION


If PIKKO proves to be effective, recommendations can be made to health organizations, which should lead to the concept being rolled out throughout Germany and included into oncological guidelines. We expect PIKKO to be a useful addition to usual cancer care, helping to improve the quality of life of cancer patients and reduce healthcare costs.
TRIAL REGISTRATION


This study was retrospectively registered in the German Clinical Trial Register under DRKS00016703 (21.02.2019, the reason for the delay was the prioritization of the study management in the first year to establish the new approach into practice). https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00016703.",2020,"PIKKO is designed to improve quality of life, self-efficacy, health literacy and patient satisfaction and to reduce psychological distress, related health care costs and the days of inability to work.","['Cancer patients', 'overall oncological patients']",['supportive care intervention'],"['quality of life, self-efficacy, health literacy and patient satisfaction', 'health related quality of life (SF-12', 'self-efficacy (GSE), psychological distress such as depression (PHQ-9) or anxiety (GAD-7), health literacy (HLS-EU-Q47) and patient satisfaction in health care (Qualiskope-A']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]","[{'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]",,0.0946291,"PIKKO is designed to improve quality of life, self-efficacy, health literacy and patient satisfaction and to reduce psychological distress, related health care costs and the days of inability to work.","[{'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Schneider', 'Affiliation': 'Institute of Psychosocial Medicine and Psychotherapy, Jena University Hospital, Stoystrasse 3, 07740, Jena, Germany. nico.schneider@med.uni-jena.de.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bäcker', 'Affiliation': 'Institute of Psychosocial Medicine and Psychotherapy, Jena University Hospital, Stoystrasse 3, 07740, Jena, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Brenk-Franz', 'Affiliation': 'Institute of Psychosocial Medicine and Psychotherapy, Jena University Hospital, Stoystrasse 3, 07740, Jena, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Keinki', 'Affiliation': 'German Cancer Society, Kuno-Fischer-Strasse 8, 14057, Berlin, Germany.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Hübner', 'Affiliation': 'Department of Hematology and Medical Oncology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Brandt', 'Affiliation': 'IKK Südwest, Berliner Promenade 1, 66111, Saarbrücken, Germany.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'von der Winkel', 'Affiliation': 'IKK Südwest, Berliner Promenade 1, 66111, Saarbrücken, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Hager', 'Affiliation': 'ze:roPraxen, Bodelschwinghstrasse 10/3, 68723, Schwetzingen, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Strauss', 'Affiliation': 'Institute of Psychosocial Medicine and Psychotherapy, Jena University Hospital, Stoystrasse 3, 07740, Jena, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Altmann', 'Affiliation': 'Institute of Psychosocial Medicine and Psychotherapy, Jena University Hospital, Stoystrasse 3, 07740, Jena, Germany.'}]",BMC medical research methodology,['10.1186/s12874-020-01002-1']
1587,32414347,"The PAPHIO study protocol: a randomised controlled trial with a 2 x 2 crossover design of physical activity adherence, psychological health and immunological outcomes in breast cancer survivors.","BACKGROUND


The PAPHIO study; a randomized controlled trial with 2X2 crossover design will implement a self-directed physical activity program in which participants will engage in self-monitoring and receive motivational interviewing to enhance physical activity adherence. The study aims to determine the effects of 24 weeks self-directed activity combined with motivational interviewing (MI) on (i) psychological health, (ii) quality of life (QoL) and (iii) immune function in female breast cancer survivors.
METHODS


The study will recruit 64 female breast cancer survivors within 3 years of diagnosis and at least 6 months post primary treatments at Western Health Sunshine Hospital, Melbourne, Australia. They will be randomly allocated to immediate intervention (IIG group) or delayed intervention groups (DIG group) in a 1:1 ratio. All participants will be given a wearable device (Fitbit Alta HR) and undertake self-directed physical activity for 24 weeks and will receive MI for 12 weeks (IIG; during week 0 to week 12 and DIG; during week 13 to week 24). Participants' daily step count and the changes of immune cell functionality will be assessed at the beginning (week 1: T1), week 12 (T2) and week 24 (T3) of the program. Physical activity adherence will be assessed at T2 and T3. Participants will also complete four questionnaires assessing exercise self-regulation (BREQ2), exercise barrier and task self-efficacy, mental health (DASS-21) and QoL (FACT-B) at three time points (T1 to T3). Linear-mixed models will be used to assess the relationship between physical activity volume by step counting and mental health (DASS-21), QoL (FACT-B), immune biomarkers, self-regulation (BREQ2) and self-efficacy at T1, T2 and T3;between 2 groups.
DISCUSSION


We expect this physical activity intervention to be acceptable and beneficial to the participants in terms of psychological and immunological well-being with the potential outcomes to be implemented more widely at relatively low cost to these or other patient populations.
TRIAL REGISTRATION


Australian New Zealand Clinical trials Registry- ACTRN12619001271190. Prospectively registered on 13 September 2019.",2020,"We expect this physical activity intervention to be acceptable and beneficial to the participants in terms of psychological and immunological well-being with the potential outcomes to be implemented more widely at relatively low cost to these or other patient populations.
","['Prospectively registered on 13 September 2019', 'breast cancer survivors', 'female breast cancer survivors', '64 female breast cancer survivors within 3\xa0years of diagnosis and at least 6\xa0months post primary treatments at Western Health Sunshine Hospital, Melbourne, Australia']","['physical activity intervention', 'immediate intervention (IIG group) or delayed intervention', 'physical activity adherence, psychological health', 'Registry', 'motivational interviewing', '24\u2009weeks self-directed activity combined with motivational interviewing (MI', 'self-directed physical activity program']","['Physical activity adherence', 'physical activity volume by step counting and mental health (DASS-21), QoL (FACT-B), immune biomarkers, self-regulation (BREQ2) and self-efficacy', 'i) psychological health, (ii) quality of life (QoL) and (iii) immune function', 'questionnaires assessing exercise self-regulation (BREQ2), exercise barrier and task self-efficacy, mental health (DASS-21) and QoL (FACT-B', 'immune cell functionality', 'physical activity adherence']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]",,0.0682482,"We expect this physical activity intervention to be acceptable and beneficial to the participants in terms of psychological and immunological well-being with the potential outcomes to be implemented more widely at relatively low cost to these or other patient populations.
","[{'ForeName': 'Supa', 'Initials': 'S', 'LastName': 'Pudkasam', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, VIC, Australia. supa.pudkasam@live.vu.edu.au.'}, {'ForeName': 'Meron', 'Initials': 'M', 'LastName': 'Pitcher', 'Affiliation': 'Breast Cancer Service, Western Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'Breast Cancer Service, Western Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': ""O'Connor"", 'Affiliation': 'IPC Health Altona Meadows, Melbourne, VIC, Australia.'}, {'ForeName': 'Nanthaphan', 'Initials': 'N', 'LastName': 'Chinlumprasert', 'Affiliation': 'Bernadette de Lourdes School of Nursing Science, Assumption University, Bangkok, Thailand.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Stojanovska', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, VIC, Australia.'}, {'ForeName': 'Remco', 'Initials': 'R', 'LastName': 'Polman', 'Affiliation': 'School of Exercise and Nutrition Sciences, Faculty of Health, Queensland University of Technology, Brisbane, Qld, Australia.'}, {'ForeName': 'Vasso', 'Initials': 'V', 'LastName': 'Apostolopoulos', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, VIC, Australia. vasso.apostolopoulos@vu.edu.au.'}]",BMC public health,['10.1186/s12889-020-08827-x']
1588,32414563,Impact of an educational intervention in primary care on fasting blood glucose levels and diabetes knowledge among patients with type 2 diabetes mellitus in rural China.,"OBJECTIVE


To assess the impact of an educational intervention for type 2 diabetes mellitus (T2DM) in primary care in rural China, on fasting blood glucose (FBG) level and diabetes knowledge.
METHODS


Patients with T2DM (n = 1,589) in 18 township health centres in three counties in Jiangsu Province were randomly divided into an intervention group receiving educational intervention and follow-up visits, and a control group with standard care. Questionnaires and medical records, including FBG level and diabetes knowledge score, were compared, at baseline and follow-up. Propensity score matching and Difference-in-Difference analysis were used.
RESULTS


The FBG level decreased significantly in the intervention group compared to the control group, DID=-0.53 mmol/l, (CI95 % -0.90 to -0.16). The diabetes knowledge score increased significantly in the intervention group compared to the control group, DID = 0.91, (CI95 % 0.64-1.18). The FBG level and diabetes knowledge score improved significantly in the intervention group in all counties.
CONCLUSIONS


The educational intervention and increased collaboration between hospitals and primary care improved the FBG level and diabetes knowledge score in the intervention group compared to the control group after one year.
PRACTICE IMPLICATIONS


Educational intervention and increased collaboration between hospitals and primary care may improve diabetes care in rural China.",2020,"The educational intervention and increased collaboration between hospitals and primary care improved the FBG level and diabetes knowledge score in the intervention group compared to the control group after one year.
","['Patients with T2DM (n = 1,589) in 18 township health centres in three counties in Jiangsu Province', 'patients with type 2 diabetes mellitus in rural China', 'rural China', 'type 2 diabetes mellitus (T2DM) in primary care in rural China, on fasting blood glucose (FBG) level and diabetes knowledge']","['educational intervention', 'intervention group receiving educational intervention and follow-up visits, and a control group with standard care']","['diabetes knowledge score', 'FBG level and diabetes knowledge score', 'FBG level', 'fasting blood glucose levels and diabetes knowledge', 'Questionnaires and medical records, including FBG level and diabetes knowledge score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",1589.0,0.023265,"The educational intervention and increased collaboration between hospitals and primary care improved the FBG level and diabetes knowledge score in the intervention group compared to the control group after one year.
","[{'ForeName': 'Shaofan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Health Outcomes and Economic Evaluation Research Group, Stockholm Centre for Healthcare Ethics, Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, SE-17177 Stockholm, Sweden; Equity and Health Policy Research Group, Department of Global Public Health, Karolinska Institutet, SE-17177 Stockholm, Sweden; School of Health Policy and Management, Nanjing Medical University, No. 101 Longmian Avenue, Nanjing 211166, China. Electronic address: shaofan.chen@ki.se.'}, {'ForeName': 'Dongfu', 'Initials': 'D', 'LastName': 'Qian', 'Affiliation': 'School of Health Policy and Management, Nanjing Medical University, No. 101 Longmian Avenue, Nanjing 211166, China. Electronic address: dqian@njmu.edu.cn.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Burström', 'Affiliation': 'Health Outcomes and Economic Evaluation Research Group, Stockholm Centre for Healthcare Ethics, Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, SE-17177 Stockholm, Sweden; Equity and Health Policy Research Group, Department of Global Public Health, Karolinska Institutet, SE-17177 Stockholm, Sweden; Center for Health Policy Studies, Nanjing Medical University, No. 101 Longmian Avenue, Nanjing 211166, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Burström', 'Affiliation': 'Equity and Health Policy Research Group, Department of Global Public Health, Karolinska Institutet, SE-17177 Stockholm, Sweden; Center for Health Policy Studies, Nanjing Medical University, No. 101 Longmian Avenue, Nanjing 211166, China.'}]",Patient education and counseling,['10.1016/j.pec.2020.03.010']
1589,32414376,Implementation and adoption of a health insurance support tool in the electronic health record: a mixed methods analysis within a randomized trial.,"BACKGROUND


In addition to delivering vital health care to millions of patients in the United States, community health centers (CHCs) provide needed health insurance outreach and enrollment support to their communities. We developed a health insurance enrollment tracking tool integrated within the electronic health record (EHR) and conducted a hybrid implementation-effectiveness trial in a CHC-based research network to assess tool adoption using two implementation strategies.
METHODS


CHCs were recruited from the OCHIN practice-based research network. Seven health center systems (23 CHC clinic sites) were recruited and randomized to receive basic educational materials alone (Arm 1), or these materials plus facilitation (Arm 2) during the 18-month study period, September 2016-April 2018. Facilitation consisted of monthly contacts with clinic staff and utilized audit and feedback and guided improvement cycles. We measured total and monthly tool utilization from the EHR. We conducted structured interviews of CHC staff to assess factors associated with tool utilization. Qualitative data were analyzed using an immersion-crystallization approach with barriers and facilitators identified using the Consolidated Framework for Implementation Research.
RESULTS


The majority of CHCs in both study arms adopted the enrollment tool. The rate of tool utilization was, on average, higher in Arm 2 compared to Arm 1 (20.0% versus 4.7%, p < 0.01). However, by the end of the study period, the rate of tool utilization was similar in both arms; and observed between-arm differences in tool utilization were largely driven by a single, large health center in Arm 2. Perceived relative advantage of the tool was the key factor identified by clinic staff as driving tool utilization. Implementation climate and leadership engagement were also associated with tool utilization.
CONCLUSIONS


Using basic education materials and low-intensity facilitation, CHCs quickly adopted an EHR-based tool to support critical outreach and enrollment activities aimed at improving access to health insurance in their communities. Though facilitation carried some benefit, a CHC's perceived relative advantage of the tool was the primary driver of decisions to implement the tool.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02355262, Posted February 4, 2015.",2020,"The rate of tool utilization was, on average, higher in Arm 2 compared to Arm 1 (20.0% versus 4.7%, p < 0.01).","['Seven health center systems (23 CHC clinic sites', 'CHCs were recruited from the OCHIN practice-based research network']","['health insurance enrollment tracking tool integrated within the electronic health record (EHR', 'basic educational materials alone']",['rate of tool utilization'],"[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1861453', 'cui_str': 'Pseudohyperkalemia Cardiff'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.135831,"The rate of tool utilization was, on average, higher in Arm 2 compared to Arm 1 (20.0% versus 4.7%, p < 0.01).","[{'ForeName': 'Brigit', 'Initials': 'B', 'LastName': 'Hatch', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA. adamusb@ohsu.edu.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Tillotson', 'Affiliation': 'OCHIN, 1881 SW Naito Parkway, Portland, OR, 97201, USA.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Huguet', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Marino', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Baron', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Nelson', 'Affiliation': 'OCHIN, 1881 SW Naito Parkway, Portland, OR, 97201, USA.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Sumic', 'Affiliation': 'OCHIN, 1881 SW Naito Parkway, Portland, OR, 97201, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Cohen', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'E DeVoe', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA.'}]",BMC health services research,['10.1186/s12913-020-05317-z']
1590,32414368,Preparing for an orthopedic consultation using an eHealth tool: a randomized controlled trial in patients with hip and knee osteoarthritis.,"BACKGROUND


To evaluate the effect of a stand-alone mobile and web-based educational intervention (eHealth tool) compared to usual preparation of a first orthopedic consultation of patients with hip or knee osteoarthritis (OA) on patients' satisfaction.
METHODS


A two-armed randomized controlled trial involving 286 patients with (suspicion of) hip or knee OA, randomly allocated to either receiving an educational eHealth tool to prepare their upcoming consultation (n = 144) or usual care (n = 142). Satisfaction with the consultation on three subscales (range 1-4) of the Consumer Quality Index (CQI - primary outcome) and knowledge (assessed using 22 statements on OA, range 0-22), treatment beliefs (assessed by the Treatment beliefs in OsteoArthritis questionnaire, range 1-5), assessment of patient's involvement in consultation by the surgeon (assessed on a 5-point Likert scale) and patient satisfaction with the outcome of the consultation (numeric rating scale), were assessed.
RESULTS


No differences between groups were observed on the 3 subscales of the CQI (group difference (95% CI): communication 0.009 (- 0.10, 0.12), conduct - 0.02 (- 0.12, 0.07) and information provision 0.02 (- 0.18, 0.21)). Between group differences (95% CI) were in favor of the intervention group for knowledge (1.4 (0.6, 2.2)), negative beliefs regarding physical activities (- 0.19 (- 0.37, - 0.002) and pain medication (- 0.30 (- 0.49, - 0.01)). We found no differences on other secondary outcomes.
CONCLUSIONS


An educational eHealth tool to prepare a first orthopedic consultation for hip or knee OA does not result in higher patient satisfaction with the consultation, but it does influence cognitions about osteoarthritis.
TRIAL REGISTRATION


Dutch Trial Register (trial number NTR6262). Registered 30 January 2017.",2020,"An educational eHealth tool to prepare a first orthopedic consultation for hip or knee OA does not result in higher patient satisfaction with the consultation, but it does influence cognitions about osteoarthritis.
","['patients with hip and knee osteoarthritis', '286 patients with (suspicion of) hip or knee OA', ""patients with hip or knee osteoarthritis (OA) on patients' satisfaction""]","['educational eHealth tool to prepare their upcoming consultation (n\u2009=\u2009144) or usual care', 'stand-alone mobile and web-based educational intervention (eHealth tool']","[""Consumer Quality Index (CQI - primary outcome) and knowledge (assessed using 22 statements on OA, range 0-22), treatment beliefs (assessed by the Treatment beliefs in OsteoArthritis questionnaire, range 1-5), assessment of patient's involvement in consultation by the surgeon (assessed on a 5-point Likert scale) and patient satisfaction with the outcome of the consultation (numeric rating scale"", 'pain medication', 'negative beliefs regarding physical activities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030699', 'cui_str': 'Client participation'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",286.0,0.118311,"An educational eHealth tool to prepare a first orthopedic consultation for hip or knee OA does not result in higher patient satisfaction with the consultation, but it does influence cognitions about osteoarthritis.
","[{'ForeName': 'Aniek A O M', 'Initials': 'AAOM', 'LastName': 'Claassen', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, PO Box 9011, Nijmegen, GM, 6500, The Netherlands. a.claassen@maartenskliniek.nl.'}, {'ForeName': 'Henk J', 'Initials': 'HJ', 'LastName': 'Schers', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Vincent J J F', 'Initials': 'VJJF', 'LastName': 'Busch', 'Affiliation': 'Department of Orthopaedic Surgery, Sint Maartenskliniek, Nijmegen, The Netherlands.'}, {'ForeName': 'Petra J C', 'Initials': 'PJC', 'LastName': 'Heesterbeek', 'Affiliation': 'Sint Maartenskliniek Research, Sint Maartenskliniek, Nijmegen, The Netherlands.'}, {'ForeName': 'Frank H J', 'Initials': 'FHJ', 'LastName': 'van den Hoogen', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, PO Box 9011, Nijmegen, GM, 6500, The Netherlands.'}, {'ForeName': 'Thea P M', 'Initials': 'TPM', 'LastName': 'Vliet Vlieland', 'Affiliation': 'Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Cornelia H M', 'Initials': 'CHM', 'LastName': 'van den Ende', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, PO Box 9011, Nijmegen, GM, 6500, The Netherlands.'}]",BMC medical informatics and decision making,['10.1186/s12911-020-01130-0']
1591,32414398,Individuals living in an onchocerciasis focus and treated three-monthly with ivermectin develop fewer new onchocercal nodules than individuals treated annually.,"BACKGROUND


Little information is available on the effect of ivermectin on the third- and fourth-stage larvae of Onchocerca volvulus. To assess a possible prophylactic effect of ivermectin on this parasite, we compared the effects of different ivermectin regimens on the acquisition of onchocercal nodules.
METHODS


We analyzed data from a controlled randomized clinical trial of ivermectin conducted in the Mbam Valley (Cameroon) between 1994 and 1998 in a cohort of onchocerciasis infected individuals. The number of nodules that appeared between the start and the end of the clinical trial was analyzed, using ANOVA and multivariable Poisson regressions, between four treatment arms: 150 µg/kg annually, 800 µg/kg annually, 150 µg/kg 3-monthly, and 800 µg/kg 3-monthly.
RESULTS


The mean number of nodules that appeared during the trial was reduced by 17.7% in subjects treated 3-monthly compared to those treated annually (regardless of the dose). Poisson regression model, adjusting on subject's age and weight, initial number of nodules and intensity of O. volvulus infection in his village of residence, confirmed that the incidence of new nodules was reduced in 3-monthly treatment arms compared to annually treatment arms, and that the dosage of ivermectin does not seem to influence this effect. Furthermore, the number of newly acquired nodules was positively associated with the initial number of nodules. Analysis of disappearance of nodules did not show any significant difference between the treatment groups.
CONCLUSIONS


To our knowledge, these results suggest for the first time in humans, that ivermectin has a partial prophylactic effect on O. volvulus. Three-monthly treatment seems more effective than annual treatment to prevent the appearance of nodules.",2020,The mean number of nodules that appeared during the trial was reduced by 17.7% in subjects treated 3-monthly compared to those treated annually (regardless of the dose).,['Mbam Valley (Cameroon) between 1994 and 1998 in a cohort of onchocerciasis infected individuals'],['ivermectin'],"['mean number of nodules', 'number of nodules']","[{'cui': 'C0563004', 'cui_str': 'Valley'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0029001', 'cui_str': 'Infection by Onchocerca volvulus'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}]",,0.060998,The mean number of nodules that appeared during the trial was reduced by 17.7% in subjects treated 3-monthly compared to those treated annually (regardless of the dose).,"[{'ForeName': 'Jérémy T', 'Initials': 'JT', 'LastName': 'Campillo', 'Affiliation': 'UMI 233, Institut de Recherche pour le Développement (IRD) and University of Montpellier 1, 911 avenue Agropolis, P.O. Box 64501, 34394, Montpellier Cedex 5, France.'}, {'ForeName': 'Cédric B', 'Initials': 'CB', 'LastName': 'Chesnais', 'Affiliation': 'UMI 233, Institut de Recherche pour le Développement (IRD) and University of Montpellier 1, 911 avenue Agropolis, P.O. Box 64501, 34394, Montpellier Cedex 5, France.'}, {'ForeName': 'Sébastien D S', 'Initials': 'SDS', 'LastName': 'Pion', 'Affiliation': 'UMI 233, Institut de Recherche pour le Développement (IRD) and University of Montpellier 1, 911 avenue Agropolis, P.O. Box 64501, 34394, Montpellier Cedex 5, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Gardon', 'Affiliation': 'Hydrosciences Montpellier, Institut de Recherche pour le Développement (IRD), Montpellier, France.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Kamgno', 'Affiliation': 'Centre for Research on Filariasis and other Tropical Diseases (CRFilMT), P.O. Box 5797, Yaoundé, Cameroon.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Boussinesq', 'Affiliation': 'UMI 233, Institut de Recherche pour le Développement (IRD) and University of Montpellier 1, 911 avenue Agropolis, P.O. Box 64501, 34394, Montpellier Cedex 5, France. michel.boussinesq@ird.fr.'}]",Parasites & vectors,['10.1186/s13071-020-04126-x']
1592,32414405,"""[Repeat] testing and counseling is one of the key [services] that the government should continue providing"": participants' perceptions on extended repeat HIV testing and enhanced counseling (ERHTEC) for primary HIV prevention in pregnant and lactating women in the PRIMAL study, Uganda.","BACKGROUND


The 'Primary HIV Prevention among Pregnant and Lactating Ugandan Women' (PRIMAL) randomized controlled trial aimed to assess an enhanced counseling strategy linked to extended postpartum repeat HIV testing and enhanced counseling among 820 HIV-negative pregnant and lactating women aged 18-49 years and 410 of their male partners to address the first pillar of the WHO Global Strategy for the Prevention of Mother-to-Child HIV transmission (PMTCT). This paper presents findings of qualitative studies aimed at evaluating participants' and service providers' perceptions on the acceptability and feasibility of the intervention and at understanding the effects of the intervention on risk reduction, couple communication, and emotional support from women's partners.
METHODS


PRIMAL Study participants were enrolled from two antenatal care clinics and randomized 1:1 to an intervention or control arm. Both arms received repeat sexually transmitted infections (STI) and HIV testing at enrolment, labor and delivery, and at 3, 6, 12, 18 and 24 months postpartum. The intervention consisted of enhanced quarterly counseling on HIV risk reduction, couple communication, family planning and nutrition delivered by study counselors through up to 24 months post-partum. Control participants received repeat standard post-test counseling. Qualitative data were collected from intervention women participants, counsellors and midwives at baseline, midline and end of the study through 18 focus group discussions and 44 key informant interviews. Data analysis followed a thematic approach using framework analysis and a matrix-based system for organizing, reducing, and synthesizing data.
RESULTS


At baseline, FGD participants mentioned multiple sexual partners and lack of condom use as the main risks for pregnant and lactating women to acquire HIV. The main reasons for having multiple sexual partners were 1) the cultural practice not to have sex in the late pre-natal and early post-natal period; 2) increased sexual desire during pregnancy; 3) alcohol abuse; 4) poverty; and 5) conflict in couples. Consistent condom use at baseline was limited due to lack of knowledge and low acceptance of condom use in couples. The majority of intervention participants enrolled as couples felt enhanced counselling improved understanding, faithfulness, mutual support and appreciation within their couple. Another benefit mentioned by participants was improvement of couple communication and negotiation, as well as daily decision-making around sexual needs, family planning and condom use. Participants stressed the importance of providing counselling services to all couples.
CONCLUSION


This study shows that enhanced individual and couple counselling linked to extended repeat HIV and STI testing and focusing on HIV prevention, couple communication, family planning and nutrition is a feasible and acceptable intervention that could enhance risk reduction programs among pregnant and lactating women.
TRIAL REGISTRATION


ClinicalTrials.gov registration number NCT01882998, date of registration 21st June 2013.",2020,"Another benefit mentioned by participants was improvement of couple communication and negotiation, as well as daily decision-making around sexual needs, family planning and condom use.","[""women's partners"", '820 HIV-negative pregnant and lactating women aged 18-49\u2009years and 410 of their male partners to address the first pillar of the WHO Global Strategy for the Prevention of Mother-to-Child HIV transmission (PMTCT', 'PRIMAL Study participants were enrolled from two antenatal care clinics', 'pregnant and lactating women in the PRIMAL study, Uganda', 'pregnant and lactating women', 'Pregnant and Lactating', 'Ugandan Women']","['enhanced quarterly counseling on HIV risk reduction, couple communication, family planning and nutrition delivered by study counselors through up to 24\u2009months post-partum', 'enhanced counseling strategy linked to extended postpartum repeat HIV testing and enhanced counseling', 'Repeat] testing and counseling', 'repeat standard post-test counseling']","['risk reduction, couple communication, and emotional support', 'understanding, faithfulness, mutual support and appreciation within their couple']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1571885', 'cui_str': 'Professional counselor'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C3714360', 'cui_str': 'Counseling strategy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",,0.0739136,"Another benefit mentioned by participants was improvement of couple communication and negotiation, as well as daily decision-making around sexual needs, family planning and condom use.","[{'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Bannink Mbazzi', 'Affiliation': 'Medical Research Council / Uganda Virus Research Institute & London School of Hygiene and Tropical Medicine Uganda Research Unit, P.O. Box 49, Entebbe, Uganda. femke.bannink@mrcuganda.org.'}, {'ForeName': 'Zikulah', 'Initials': 'Z', 'LastName': 'Namukwaya', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Amone', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Ojok', 'Affiliation': 'AVSI Foundation, Kampala, Uganda.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Etima', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Josaphat', 'Initials': 'J', 'LastName': 'Byamugisha', 'Affiliation': 'Department of Obstetrics and Gynecology, Makerere University School of Medicine, Kampala, Uganda.'}, {'ForeName': 'Elly', 'Initials': 'E', 'LastName': 'Katabira', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Jaco', 'Initials': 'J', 'LastName': 'Homsy', 'Affiliation': 'Institute for Global Health Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'King', 'Affiliation': 'Institute for Global Health Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC public health,['10.1186/s12889-020-08738-x']
1593,31627773,Challenges in conducting trials for pediatric tuberculous meningitis: lessons from the field.,"SETTING:  TBM-KIDS is a phase I/II trial enrolling children with tuberculous meningitis (TBM) in three tertiary referral centers in India and Malawi. OBJECTIVE:  To describe the challenges encountered in conducting the first randomized clinical trial of antimicrobial agents in pediatric TBM. DESIGN:  The sources of the data were primarily monthly trial reports, non-enrollment case report forms, study diaries and registers maintained for recruitment, experiences shared by key team members during regular study calls and comments from site review visits. We reviewed, broadly categorized, and describe in detail the challenges encountered by study teams in trial implementation. RESULTS:  Over 17 months, 3371 children with clinical presentations consistent with meningoencephalitis or undergoing lumbar puncture were assessed for eligibility; 21 (<1%) met enrollment criteria. We encountered challenges related to diagnosis, management of sick children, large catchment areas, adverse event attribution, concomitant medications, infrastructure requirements, expensive pediatric formulations with short expiry, and detection of treatment response in a highly variable disease across the age continuum. Training and adaptation of tools for neurocognitive and neurologic function assessment were necessary. Special care was undertaken to explain study participation to distraught caregivers and manage children longitudinally. CONCLUSION:  Interventional trials in pediatric TBM are challenging but are critically important for improving the treatment of a disease that disables children physically, cognitively and emotionally. Sharing these challenges may help to address them more effectively as a TB research community and to advance treatments for this at-risk population.",2019,"Interventional trials in pediatric TBM are challenging but are critically important for improving the treatment of a disease that disables children physically, cognitively and emotionally.","['3371 children with clinical presentations consistent with meningoencephalitis or undergoing lumbar puncture were assessed for eligibility; 21 (<1%) met enrollment criteria', 'pediatric TBM', 'pediatric tuberculous meningitis', 'children with tuberculous meningitis (TBM) in three tertiary referral centers in India and Malawi']",[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0025309', 'cui_str': 'Meningoencephalitis'}, {'cui': 'C0037943', 'cui_str': 'Lumbar puncture'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C0041318', 'cui_str': 'Tuberculosis of meninges'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}]",[],[],3371.0,0.0523155,"Interventional trials in pediatric TBM are challenging but are critically important for improving the treatment of a disease that disables children physically, cognitively and emotionally.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Paradkar', 'Affiliation': 'Byramjee Jeejeebhoy Government Medical College-Johns Hopkins Clinical Research Site, Pune.'}, {'ForeName': 'D B', 'Initials': 'DB', 'LastName': 'Devaleenal', 'Affiliation': 'National Institute for Research in Tuberculosis, Indian Council for Medical Research, Chennai, India.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mvalo', 'Affiliation': 'University of North Carolina Project-Malawi, Lilongwe, Malawi, Department of Pediatrics, School of Medicine, University of North Carolina at Chapel Hill, NC.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Arenivas', 'Affiliation': 'The Institute for Rehabilitation and Research Memorial Hermann, Department of Rehabilitation Psychology and Neuropsychology, Houston, TX, Baylor College of Medicine, Department of Physical Medicine and Rehabilitation, Houston, TX.'}, {'ForeName': 'K T', 'Initials': 'KT', 'LastName': 'Thakur', 'Affiliation': 'Department of Neurology, Columbia University College of Physicians and Surgeons, New York, NY, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Afrin', 'Affiliation': 'Byramjee Jeejeebhoy Government Medical College-Johns Hopkins Clinical Research Site, Pune.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Giridharan', 'Affiliation': 'National Institute for Research in Tuberculosis, Indian Council for Medical Research, Chennai, India.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Selladurai', 'Affiliation': 'Institute of Child Health and Hospital for Children, Chennai.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kinikar', 'Affiliation': 'Byramjee Jeejeebhoy Government Medical College-Johns Hopkins Clinical Research Site, Pune, BJ Government Medical College, Pune, India.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Valvi', 'Affiliation': 'Byramjee Jeejeebhoy Government Medical College-Johns Hopkins Clinical Research Site, Pune, BJ Government Medical College, Pune, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Mave', 'Affiliation': 'Byramjee Jeejeebhoy Government Medical College-Johns Hopkins Clinical Research Site, Pune, BJ Government Medical College, Pune, India.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Dooley', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease,['10.5588/ijtld.18.0786']
1594,32414411,Steps to recovery: body weight-supported treadmill training for critically ill patients: a randomized controlled trial.,"BACKGROUND


Early mobilization has been proven effective for patients in intensive care units (ICUs) to improve functional recovery. However, early mobilization of critically ill, often mechanically ventilated, patients is cumbersome because of the attachment to tubes, drains, monitoring devices and muscle weakness. A mobile treadmill with bodyweight support may help to initiate mobilization earlier and more effectively. The aim of this study is to assess the effectiveness of weight-supported treadmill training in critically ill patients during and after ICU stay on time to independent functional ambulation.
METHODS


In this randomized controlled trial, a custom-built bedside body weight-supported treadmill will be used and evaluated. Patients are included if they have been mechanically ventilated for at least 48 hours, are able to follow instructions, have quadriceps muscle strength of Medical Research Council sum-score 2 (MRC 2) or higher, can sit unsupported and meet the safety criteria for physical exercise. Exclusion criteria are language barriers, no prior walking ability, contraindications for physiotherapy or a neurological condition as reason for ICU admission. We aim to include 88 patients and randomize them into either the intervention or the control group. The intervention group will receive usual care plus bodyweight-supported treadmill training (BWSTT) daily. The BWSSTT consists of walking on a mobile treadmill while supported by a harness. The control group will receive usual care physiotherapy treatment daily consisting of progressive activities such as bed-cycling and active functional training exercises. In both groups, we will aim for a total of 40 minutes of physiotherapy treatment time every day in one or two sessions, as tolerated by the patient. The primary outcome is time to functional ambulation as measured in days, secondary outcomes include walking distance, muscle strength, status of functional mobility and symptoms of post-traumatic stress. All measurements will be done by assessors who are blinded to the intervention on the regular wards until hospital discharge.
DISCUSSION


This will be the first study comparing the effects of BWSTT and conventional physiotherapy for critically ill patients during and after ICU stay. The results of this study contribute to a better understanding of the effectiveness of early physiotherapy interventions for critically ill patients.
TRIAL REGISTRATION


Dutch Trial Register (NTR) ID: NL6766. Registered at 1 December 2017.",2020,This will be the first study comparing the effects of BWSTT and conventional physiotherapy for critically ill patients during and after ICU stay.,"['patients in intensive care units (ICUs', 'critically ill patients during and after ICU stay', '88 patients and randomize them into either the intervention or the control group', 'critically ill patients', 'critically ill patients during and after ICU stay on time to independent functional ambulation', 'Patients are included if they have been mechanically ventilated for at least 48\u2009hours, are able to follow instructions, have quadriceps muscle strength of Medical Research Council sum-score 2 (MRC 2) or higher, can sit unsupported and meet the safety criteria for physical exercise']","['conventional physiotherapy', 'usual care plus bodyweight-supported treadmill training (BWSTT) daily', 'usual care physiotherapy treatment daily consisting of progressive activities such as bed-cycling and active functional training exercises', 'weight-supported treadmill training']","['time to functional ambulation as measured in days, secondary outcomes include walking distance, muscle strength, status of functional mobility and symptoms of post-traumatic stress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0578715', 'cui_str': 'Does sit unsupported'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",,0.130516,This will be the first study comparing the effects of BWSTT and conventional physiotherapy for critically ill patients during and after ICU stay.,"[{'ForeName': 'Robin C H', 'Initials': 'RCH', 'LastName': 'Kwakman', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Juultje', 'Initials': 'J', 'LastName': 'Sommers', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Janneke', 'Initials': 'J', 'LastName': 'Horn', 'Affiliation': 'Department of Intensive Care, Neurosciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Nollet', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Raoul H H', 'Initials': 'RHH', 'LastName': 'Engelbert', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Marike', 'Initials': 'M', 'LastName': 'van der Schaaf', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands. m.vanderschaaf@amsterdamumc.nl.'}]",Trials,['10.1186/s13063-020-04333-y']
1595,32414425,Temporary interruption of baricitinib: characterization of interruptions and effect on clinical outcomes in patients with rheumatoid arthritis.,"BACKGROUND


In clinical practice, temporary interruption of rheumatoid arthritis (RA) therapy is common for various reasons including side effects, non-compliance, or necessity for surgery. To characterize temporary interruptions of baricitinib and placebo-matched tablets in phase 3 studies of patients with moderate-to-severe rheumatoid arthritis (RA) and describe their impact on efficacy and safety.
METHODS


During 4 baricitinib phase 3 studies, investigators documented timing, reason, and duration of investigator-initiated temporary interruptions of study drug. In 2 studies, patients recorded RA symptoms in daily diaries for 12 weeks. Post hoc analyses investigated changes in symptom scores during interruptions and resumption of treatment. Interruptions were evaluated for reoccurrence of adverse events or laboratory abnormalities after retreatment.
RESULTS


Across the placebo-controlled studies, interruptions occurred in larger proportions of baricitinib- (2 mg, 18%; 4 mg, 18%) vs placebo-treated (9%) patients in only one study (bDMARD-inadequate responder patients, RA-BEACON). In the active comparator-controlled studies, the lowest rates of interruption were in the baricitinib monotherapy arm (9%) of RA-BEGIN (vs methotrexate monotherapy or combination therapy), and proportions were similar for baricitinib (10%) and adalimumab (9%) in RA-BEAM. Adverse events were the most common reason for interruption, but their reoccurrence after drug restart was infrequent. Most interruptions lasted ≤ 2 weeks. Daily diaries indicated modest symptom increases during interruption with return to pre-interruption levels or better after resumption. Interruptions had no impact on long-term efficacy outcomes.
CONCLUSIONS


Consistent with its pharmacologic properties, brief interruptions of baricitinib during phase 3 studies were associated with minor increases in RA symptoms that resolved following retreatment. This analysis provides useful information for clinicians, as temporary interruption of antirheumatic therapy is common in the care of patients with RA.
TRIAL REGISTRATION


ClinicalTrials.gov; NCT01710358, NCT01711359, NCT01721057, NCT01721044.",2020,"Interruptions had no impact on long-term efficacy outcomes.
","['patients with rheumatoid arthritis', 'patients with moderate-to-severe rheumatoid arthritis (RA', 'patients with RA']","['baricitinib', 'baricitinib and placebo-matched tablets', 'adalimumab']","['Adverse events', 'long-term efficacy outcomes', 'efficacy and safety', 'RA symptoms', 'reoccurrence of adverse events or laboratory abnormalities', 'symptom scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.490948,"Interruptions had no impact on long-term efficacy outcomes.
","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'Leeds Muscoloskeletal Biomedical Research Centre/Chapel Allerton Hospital, Chapeltown Rd, Leeds, LS7 4SA, UK. P.Emery@leeds.ac.uk.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Cardillo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Schlichting', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Rooney', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Beattie', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Helt', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Josef S', 'Initials': 'JS', 'LastName': 'Smolen', 'Affiliation': 'Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria.'}]",Arthritis research & therapy,['10.1186/s13075-020-02199-8']
1596,32414547,Efficacy of botulinum toxin for treating a gummy smile.,"INTRODUCTION


This study was conducted to investigate the efficacy of botulinum toxin applied to the different muscles of patients who have excessive gingival display and to evaluate the return to baseline gingival exposure value.
METHODS


Twenty-eight patients who had a gummy smile of more than 2 mm were randomly divided into 2 groups. Botulinum toxin was administered equally to the left and right of the levator labii superioris alaeque nasi muscle of group 1 and the orbicularis oris site of group 2. Photographs were taken, and measurements were taken before injection and at 3 days, 15 days, 1 month, 4 months, 5 months, and 6 months after injection. The visual analogue scale was used to assess the level of satisfaction.
RESULTS


The average amount of visible gingiva in group 1 was 4.92 mm at the beginning of the treatment and 1.92 mm on the 15th day. In group 2, the average amount of visible gingiva was 4.58 mm at the beginning of treatment and 2.16 mm on the 15th day. In both treatment groups, it was determined that the measurements on the sixth month did not return to their initial values. The decrease in gingival appearances in group 1 was greater than in group 2. There was no significant difference between the groups in terms of return to baseline gingival exposure value. In both groups, it was seen that the increase in satisfaction in patients was high.
CONCLUSIONS


For gummy smile correction, botulinum toxin injection is thought to be an alternative method because it is effective and conservative and has high patient satisfaction.",2020,Botulinum toxin was administered equally to the left and right of the levator labii superioris alaeque nasi muscle of group 1 and the orbicularis oris site of group 2.,"['patients who have excessive gingival display and to evaluate the return to baseline gingival exposure value', 'Twenty-eight patients who had a gummy smile of more than 2\xa0mm']","['botulinum toxin', 'Botulinum toxin', 'botulinum toxin injection']","['visual analogue scale', 'satisfaction', 'average amount of visible gingiva', 'gingival appearances', 'return to baseline gingival exposure value']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C3696916', 'cui_str': 'Gummy smile'}, {'cui': 'C0439093', 'cui_str': '>'}]","[{'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",28.0,0.0146754,Botulinum toxin was administered equally to the left and right of the levator labii superioris alaeque nasi muscle of group 1 and the orbicularis oris site of group 2.,"[{'ForeName': 'Ahmet Fatih', 'Initials': 'AF', 'LastName': 'Cengiz', 'Affiliation': 'Private Practice, Mersin, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Goymen', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Gaziantep University, Gaziantep, Turkey. Electronic address: mervegoymen@gmail.com.'}, {'ForeName': 'Cenk', 'Initials': 'C', 'LastName': 'Akcali', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Gaziantep University, Gaziantep, Turkey.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2019.07.014']
1597,32414381,Results of caring and reaching for health (CARE): a cluster-randomized controlled trial assessing a worksite wellness intervention for child care staff.,"BACKGROUND


Child care workers are among the lowest paid US workers and experience a wide array of health concerns. The physical and mental demands of their job and the lack of employer-provided health-insurance increase health risks. The Caring and Reaching for Health (CARE) study evaluated a 6-month Healthy Lifestyles intervention targeting child care workers' physical activity (primary outcome), other health behaviors, and their workplace health environment.
METHODS


Eligible child care centers, defined as being in operation for at least 2 years and employing at least four staff, were enrolled into CARE's cluster-randomized trial. Centers and their child care staff were randomly assigned to either the Healthy Lifestyles (HL) intervention arm or the Healthy Finances (HF) attention control arm using a block randomization approach. Intervention components were delivered through in-person workshops, center-level displays, informational magazines, director coaching, electronic messaging, and an interactive website. Outcome measures were collected during center visits at baseline and immediately post-intervention by trained data collectors blinded to center arm assignment. Workers' physical activity was assessed with accelerometers, worn for 7 days. Secondary outcome measures included biometric assessments of health and fitness, web-based surveys about health behaviors, and an environmental audit of workplace supports for health. Multi-level linear mixed models assessed worker- and center-level changes in these outcomes.
RESULTS


Participants included 553 child care workers representing 56 centers (HL = 250 staff/28 centers, HF = 303 staff/28 centers). At 6 months, moderate-to-vigorous physical activity declined slightly in both arms (- 1.3 min/day, 95% CI: - 3.0, 0.3 in HL; - 1.9 min/day, 95% CI: - 3.3, - 0.5 in HF), but there was no significant group by time interaction. Several secondary outcomes for other health behaviors and workplace health environment showed improvements in favor of the intervention arm, yet differences did not remain statistically significant after adjustment for multiple comparisons.
CONCLUSIONS


While the Healthy Lifestyles intervention did not improve health behaviors or the workplace health environment, results confirmed the pressing need to focus on the health of child care workers. Future interventions should focus on prevalent health issues (e.g., weight, stress), include both high-tech and high-touch intervention strategies, and address work conditions or other social determinants of health (e.g. wages) as a means of improving the health of these essential workers.
TRIAL REGISTRATION


Care2BWell: Worksite Wellness for Child Care (NCT02381938).",2020,"CONCLUSIONS


While the Healthy Lifestyles intervention did not improve health behaviors or the workplace health environment","['Centers and their child care staff', ""Eligible child care centers, defined as being in operation for at least 2 years and employing at least four staff, were enrolled into CARE's cluster-randomized trial"", 'child care staff', 'Participants included 553 child care workers representing 56 centers (HL\u2009=\u2009250 staff/28 centers, HF\u2009=\u2009303 staff/28 centers']","[""Healthy Lifestyles intervention targeting child care workers' physical activity (primary outcome), other health behaviors, and their workplace health environment"", 'Healthy Lifestyles (HL) intervention arm or the Healthy Finances (HF) attention control arm using a block randomization approach', 'worksite wellness intervention']","['biometric assessments of health and fitness, web-based surveys about health behaviors, and an environmental audit of workplace supports for health', ""Workers' physical activity"", 'moderate-to-vigorous physical activity', 'health behaviors']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008067', 'cui_str': 'Puericulture'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0376243', 'cui_str': 'finances'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008067', 'cui_str': 'Puericulture'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",,0.0874431,"CONCLUSIONS


While the Healthy Lifestyles intervention did not improve health behaviors or the workplace health environment","[{'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Linnan', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, CB 7440, Chapel Hill, North Carolina, 27599-7440, USA. linnan@email.unc.edu.'}, {'ForeName': 'Amber E', 'Initials': 'AE', 'LastName': 'Vaughn', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Falon T', 'Initials': 'FT', 'LastName': 'Smith', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Westgate', 'Affiliation': 'Department of Biostatistics, College of Public Heath, University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Hales', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Arandia', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, CB 7440, Chapel Hill, North Carolina, 27599-7440, USA.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Neshteruk', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Willis', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Dianne S', 'Initials': 'DS', 'LastName': 'Ward', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-00968-x']
1598,32414406,Sustained effects of faculty leadership development modules for clinical instructors of core competences education in Taiwan: a four-year explanatory case study.,"BACKGROUND


The Accreditation Council for Graduate Medical Education (ACGME) core competencies (CC) in general medicine-based primary care are essential for junior medical trainees. In this country, a regular faculty development (FD) program aimed at training faculty in instructing (teaching and assessing) these CC had operated. However, leadership was not emphasized. In a new intervention module, the roles and associated responsibilities of clinical instructors to conduct, design, and lead CC-based education were emphasis.
AIMS


This follow-up explanatory case study compares the effectiveness of intervention module with that of the previous regular module.
METHODS


The regular group (n = 28) comprised clinical instructors who participated in the FD module during the 2013-2014 year while the intervention group (n = 28) was composed of 2015-2016 participants. Prior to the formal (hands-on) training, participants in the intervention group were asked to study the online materials of the regular module. These participants then received a 30-h hands-on training in conducting, designing, and leading skills. Finally, they prepared a 10-h reflective end-of-module presentation of their real-world practices.
RESULTS


Following the training, a higher degree improvement in participants self-reported familiarity with CC education, self-confidence in their ability to deliver CC education and sustained involve CC education were noted among the intervention FD group, compared with the regular FD group. In the intervention group, senior academicians (associate and full professor) are more substantially involved in designing and leading CC-based courses than junior academicians (lecturers and assistant professors). Among non-teaching award winners of in the intervention FD group, the follow-up degree of sustained involvement in delivering, designing and leading CC-based courses was significantly higher than that of the regular group.
CONCLUSIONS


Our study demonstrated that leadership training in the intervention FD modules substantially motivated clinical instructors to become leaders in CC education.",2020,"Following the training, a higher degree improvement in participants self-reported familiarity with CC education, self-confidence in their ability to deliver CC education and sustained involve","['clinical instructors of core competences education in Taiwan', 'The regular group (n\u2009=\u200928) comprised clinical instructors who participated in the FD module during the 2013-2014\u2009year while the intervention group (n\u2009=\u200928) was composed of 2015-2016 participants']","['leadership training', 'faculty leadership development modules', 'regular faculty development (FD) program aimed at training faculty in instructing (teaching and assessing']",['CC education'],"[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0039401', 'cui_str': 'Education'}]","[{'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",,0.0174185,"Following the training, a higher degree improvement in participants self-reported familiarity with CC education, self-confidence in their ability to deliver CC education and sustained involve","[{'ForeName': 'Fa-Yauh', 'Initials': 'FY', 'LastName': 'Lee', 'Affiliation': 'Division of General Medicine, Taipei Veteran General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ying-Ying', 'Initials': 'YY', 'LastName': 'Yang', 'Affiliation': 'Division of General Medicine, Taipei Veteran General Hospital, Taipei, Taiwan. yangyy@vghtpe.gov.tw.'}, {'ForeName': 'Chia-Chang', 'Initials': 'CC', 'LastName': 'Huang', 'Affiliation': 'Division of General Medicine, Taipei Veteran General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ling-Ju', 'Initials': 'LJ', 'LastName': 'Huang', 'Affiliation': 'Division of General Medicine, Taipei Veteran General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ching-Chih', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Division of General Medicine, Taipei Veteran General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Jen-Feng', 'Initials': 'JF', 'LastName': 'Liang', 'Affiliation': 'Faculty of medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shiau-Shian', 'Initials': 'SS', 'LastName': 'Huang', 'Affiliation': 'Faculty of medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Shin', 'Initials': 'WS', 'LastName': 'Lee', 'Affiliation': 'Division of General Medicine, Taipei Veteran General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Dai-Yin', 'Initials': 'DY', 'LastName': 'Lu', 'Affiliation': 'Division of General Medicine, Taipei Veteran General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chiao-Lin', 'Initials': 'CL', 'LastName': 'Chuang', 'Affiliation': 'Division of General Medicine, Taipei Veteran General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ling-Yu', 'Initials': 'LY', 'LastName': 'Yang', 'Affiliation': 'Faculty of medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Hui-Chun', 'Initials': 'HC', 'LastName': 'Huang', 'Affiliation': 'Division of General Medicine, Taipei Veteran General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Boaz', 'Initials': 'B', 'LastName': 'Shulruf', 'Affiliation': 'New South Wales Sydney University, Sydney, Australia.'}, {'ForeName': 'Chen-Huan', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Faculty of medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shou-Yen', 'Initials': 'SY', 'LastName': 'Kao', 'Affiliation': 'Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}]",BMC medical education,['10.1186/s12909-020-02065-w']
1599,32414414,"Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial.","BACKGROUND


Insomnia seriously affects people's normal lives and work. However, effective treatment strategies are scarce. The purpose of this study is to explore the efficacy and safety of Jiao-tai-wan (JTW) for ameliorating insomnia symptoms caused by disharmony of the heart and kidney.
DESIGN


This is a randomized, double-blind, placebo-controlled pilot clinical trial. A total of 124 participants suffering from insomnia symptoms will be randomly assigned to the JTW or placebo group in an equal ratio. The participants will be asked to take JTW or placebo granules twice a day for 1 week. All data will be gathered at baseline and at the end of the drug intervention. The primary outcome measures will be the mean change in the Pittsburgh Sleep Quality Index (PSQI) from baseline to the end of the drug intervention. Secondary outcome measures will include the altered sleep parameters in polysomnography,  1 H-magnetic resonance spectroscopy ( 1 H-MRS) evaluation, the Disharmony of Heart and Kidney Scoring System score, and blood tests, including the levels of serum adenosine and melatonin. A laboratory test will be taken before and after treatment to assess the safety of JTW.
DISCUSSION


The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms and will also be used to monitor the safety of JTW.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1800019239. Registered on 1st November 2018.",2020,"The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms and will also be used to monitor the safety of JTW.
",['124 participants suffering from insomnia symptoms'],"['JTW or placebo', 'Jiao-tai-wan (JTW', 'JTW', 'placebo']","['mean change in the Pittsburgh Sleep Quality Index (PSQI', 'altered sleep parameters in polysomnography,  1 H-magnetic resonance spectroscopy ( 1 H-MRS) evaluation, the Disharmony of Heart and Kidney Scoring System score, and blood tests, including the levels of serum adenosine and melatonin']","[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C3849168', 'cui_str': 'jiao tai wan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}]",124.0,0.462694,"The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms and will also be used to monitor the safety of JTW.
","[{'ForeName': 'Congcong', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Wenzhou Medical University, Nanbaixiang, Ouhai District, Wenzhou, 325035, Zhejiang, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Zhejiang Chinese Medical University, Binwen Road, Binjiang District, Zhejiang, 310053, Hangzhou, China.'}, {'ForeName': 'Lufeng', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'Department of Pharm, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325035, Zhejiang, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'The 2nd Clinical College of Wenzhou Medical University, Chashan Higher Education Park, Wenzhou, 325035, Zhejiang, China.'}, {'ForeName': 'Nengzhi', 'Initials': 'N', 'LastName': 'Xia', 'Affiliation': 'X-ray Department, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325035, Zhejiang, China.'}, {'ForeName': 'Haihuan', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': 'Sleep monitoring center, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325035, Zhejiang, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': 'Research Institute of China Academy of Chinese Medical Sciences, No.16 Nanxiao Street, Dongzhimen, Dongcheng District, Beijing, 100700, China.'}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Ye', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Wenzhou Medical University, Nanbaixiang, Ouhai District, Wenzhou, 325035, Zhejiang, China. yeren601@163.com.'}, {'ForeName': 'Zhengzhong', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Wenzhou Medical University, Nanbaixiang, Ouhai District, Wenzhou, 325035, Zhejiang, China. wzyzz2008@126.com.'}]",Trials,['10.1186/s13063-020-04299-x']
1600,32414763,"Safety, Clinical Activity, and Biological Correlates of Response in Patients with Metastatic Melanoma: Results from a Phase I Trial of Atezolizumab-Response.",,2020,,['Patients with Metastatic Melanoma'],[],"['Safety, Clinical Activity, and Biological Correlates of Response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}]",[],"[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}]",,0.131922,,"[{'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'The Angeles Clinic and Research Institute, Los Angeles, California.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Bruno', 'Affiliation': 'Genentech, Inc., Marseille, France.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Fasso', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': ""O'Hear"", 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Genentech, Inc., Marseille, France.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0298']
1601,32414762,"Safety, Clinical Activity, and Biological Correlates of Response in Patients with Metastatic Melanoma: Results from a Phase I Trial of Atezolizumab-Letter.",,2020,,['Patients with Metastatic Melanoma'],[],"['Safety, Clinical Activity, and Biological Correlates of Response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}]",[],"[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}]",,0.132608,,"[{'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Goldstein', 'Affiliation': 'Tel Aviv University, Tel Aviv, Israel. danielg3@tauex.tau.ac.il.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Ratain', 'Affiliation': 'The University of Chicago, Chicago, Illinois.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3408']
1602,32414580,"Osmotherapy for malignant cerebral edema in a phase 2 prospective, double blind, randomized, placebo-controlled study of IV glibenclamide.","BACKGROUND/OBJECTIVE


Malignant edema can be a life-threatening complication of large hemispheric infarction (LHI), and is often treated with osmotherapy. In this exploratory analysis of data from the GAMES-RP study, we hypothesized that patients receiving osmotherapy had symptomatic cerebral edema, and that treatment with intravenous (IV) glibenclamide would modify osmotherapy use as compared with placebo.
METHODS


GAMES-RP was a phase 2 multi-center prospective, double blind, randomized, placebo-controlled study in LHI. Patients were randomized to IV glibenclamide (e.g. IV glyburide) or placebo. Cerebral edema therapies included osmotherapy and/or decompressive craniectomy at the discretion of the treating team. Total bolus osmotherapy dosing was quantified by ""osmolar load"". Radiographic edema was defined by dichotomizing midline shift at 24 h. Clinical changes were defined as any increase in NIHSS1a.
RESULTS


Osmotherapy was administered to 40 of the 77 patients at a median of 39 [27-55] h after stroke onset. The median baseline DWI lesion volume was significantly larger in the osmotherapy treated group (167 [146-211] mL v. 139 [112-170] mL; P=0.046). Adjudicated malignant edema (75% v. 16%; P<0.001) was more common in the osmotherapy treated group. There were no differences in the proportion of patients receiving osmotherapy or the median total osmolar load between treatment arms. Most patients (76%) had a decrease in consciousness (NIHSS item 1A ≥1) on the day they began receiving osmotherapy.
CONCLUSIONS


In the GAMES-RP trial, osmolar therapies were most often administered in response to clinical symptoms of decreased consciousness. However, the optimal timing of administration and impact on outcome after LHI have yet to be defined.",2020,Adjudicated malignant edema (75% v. 16%; P<0.001) was more common in the osmotherapy treated group.,[],"['intravenous (IV) glibenclamide', 'Osmotherapy', 'osmotherapy and/or decompressive craniectomy', 'glibenclamide (e.g. IV glyburide) or placebo', 'glibenclamide', 'placebo']","['NIHSS1a', 'median baseline DWI lesion volume', 'symptomatic cerebral edema', 'consciousness (NIHSS item 1A ≥1', 'Radiographic edema', 'median total osmolar load', 'Adjudicated malignant edema']",[],"[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C4759300', 'cui_str': 'Osmotherapy'}, {'cui': 'C2717817', 'cui_str': 'Decompressive craniectomy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0598801', 'cui_str': 'Diffusion weighted magnetic resonance imaging'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0006114', 'cui_str': 'Cerebral edema'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439351', 'cui_str': 'osmol/L'}, {'cui': 'C0017105', 'cui_str': 'Gas gangrene'}]",,0.420017,Adjudicated malignant edema (75% v. 16%; P<0.001) was more common in the osmotherapy treated group.,"[{'ForeName': 'H E', 'Initials': 'HE', 'LastName': 'Hinson', 'Affiliation': 'Departments of Neurology and Emergency Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, CR-127, Portland, OR 97239, USA. Electronic address: hinson@ohsu.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Molyneaux', 'Affiliation': 'Department of Neurology, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: molyneauxbj@upmc.edu.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'von Kummer', 'Affiliation': 'Department of Neuroradiology, Universitätsklinikum Carl Gustav Carus, Dresden, Germany. Electronic address: Ruediger.vonKummer@uniklinikum-dresden.de.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Demchuk', 'Affiliation': 'Calgary Stroke Program, Department of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada. Electronic address: ademchuk@ucalgary.ca.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Romero', 'Affiliation': 'Division of Neuroradiology, Department of Radiology, Massachusetts General Hospital, Boston, MA, USA. Electronic address: JMROMERO@mgh.harvard.edu.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Taylor Kimberly', 'Affiliation': 'Department of Neurology, Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA, USA. Electronic address: WTKIMBERLY@mgh.harvard.edu.'}, {'ForeName': 'Kevin N', 'Initials': 'KN', 'LastName': 'Sheth', 'Affiliation': 'Division of Neurocritical Care and Emergency Neurology, Yale New Haven Hospital, New Haven, CT, USA. Electronic address: kevin.sheth@yale.edu.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.104916']
1603,32414817,Broader impacts of an intervention to transform school environments on student behaviour and school functioning: post hoc analyses from the INCLUSIVE cluster randomised controlled trial.,"BACKGROUND


We have previously reported benefits for reduced bullying, smoking, alcohol and other drug use and mental health from a trial of 'Learning Together', an intervention that aimed to modify school environments and implement restorative practice and a social and emotional skill curriculum.
OBJECTIVES


To conduct post hoc theory-driven analyses of broader impacts.
DESIGN


Cluster randomised trial.
SETTINGS


40 state secondary schools in southern England.
PARTICIPANTS


Students aged 11/12 years at baseline.
OUTCOMES


Student self-reported measures at 24 and 36 months of: cyberbullying victimisation and perpetration; observations of other students perpetrating aggressive behaviours at school; own perpetration of aggressive behaviours in and outside school; perceived lack of safety at school; participation in school disciplinary procedures; truancy and e-cigarette use.
RESULTS


We found evidence of multiple impacts on other health (reduced e-cigarette use, cyberbullying perpetration, perpetration of aggressive behaviours) and educational (reduced participation in school disciplinary procedures and truancy) outcomes.
CONCLUSION


These analyses suggested that the intervention was effective in bringing about a broader range of beneficial outcomes, adding to the evidence that the intervention is a promising approach to promote adolescent health via an intervention that is attractive to schools.
TRIAL REGISTRATION NUMBER


ISRCTN10751359.",2020,"We found evidence of multiple impacts on other health (reduced e-cigarette use, cyberbullying perpetration, perpetration of aggressive behaviours) and educational (reduced participation in school disciplinary procedures and truancy) outcomes.
","['Students aged 11/12 years at baseline', '40 state secondary schools in southern England']",[],"['student behaviour and school functioning', 'aggressive behaviours in and outside school; perceived lack of safety at school; participation in school disciplinary procedures; truancy and e-cigarette use']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0014282', 'cui_str': 'England'}]",[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0424357', 'cui_str': 'Truancy'}, {'cui': 'C4083280', 'cui_str': 'Vape'}]",,0.182719,"We found evidence of multiple impacts on other health (reduced e-cigarette use, cyberbullying perpetration, perpetration of aggressive behaviours) and educational (reduced participation in school disciplinary procedures and truancy) outcomes.
","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bonell', 'Affiliation': 'Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK chris.bonell@lshtm.ac.uk.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Dodd', 'Affiliation': 'Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allen', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Bevilacqua', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McGowan', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Opondo', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Sturgess', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Elbourne', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Warren', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Russell M', 'Initials': 'RM', 'LastName': 'Viner', 'Affiliation': 'Population, Policy and Practice Research Programme, UCL Institute of Child Health, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-031589']
1604,32414888,Deep neuromuscular block improves angiographic image quality during endovascular coiling of unruptured cerebral aneurysm: a randomized clinical trial.,"BACKGROUND


Neuromuscular block (NMB) used during general anesthesia induces transient skeletal muscle paralysis, but patient movements during endovascular coiling still occur to some degree. Compared with moderate NMB, deep NMB may further improve the intervention condition during endovascular coiling for unruptured cerebral aneurysms; however, little research has focused on the angiographic image quality.
METHODS


This prospective, randomized, double-blind clinical trial included 58 patients treated for unruptured cerebral aneurysms with endovascular coiling under general anesthesia. Patients were randomly allocated to either the deep NMB group (post-tetanic count 1 or 2) or the moderate NMB group (train-of-four 1 or 2). The primary outcome was the proportion of patients with a satisfactory intervention condition assessed by surgeons after the procedure using a 5-point intervention condition rating scale (ICRS) from 1 (unable to obtain image) to 5 (optimal); ICRS 5 was defined as satisfactory.
RESULTS


There were significantly more cases of satisfactory intervention condition in the deep NMB group than in the moderate NMB group (82.1% vs 51.7%, p=0.015). The frequency of each ICRS score was significantly different between the groups (ICRS 5/4/3/2/1: 23/5/0/0/0 vs 15/9/2/3/0, p=0.035). The incidence of major patient movement requiring rescue muscle relaxant was 10.3% in the moderate NMB group and 0% in the deep NMB group (p=0.237). The drugs used to maintain hemodynamic stability were not significantly different between the two groups.
CONCLUSIONS


Deep NMB improves the intervention condition during endovascular coiling by improving the image quality.",2020,"The frequency of each ICRS score was significantly different between the groups (ICRS 5/4/3/2/1: 23/5/0/0/0 vs 15/9/2/3/0, p=0.035).","['58 patients treated for unruptured cerebral aneurysms with endovascular coiling under general anesthesia', 'endovascular coiling of unruptured cerebral aneurysm']","['Deep neuromuscular block', 'Deep NMB', 'Neuromuscular block (NMB', 'deep NMB group (post-tetanic count 1 or 2) or the moderate NMB']","['hemodynamic stability', 'angiographic image quality', 'proportion of patients with a satisfactory intervention condition assessed by surgeons after the procedure using a 5-point intervention condition rating scale (ICRS', 'frequency of each ICRS score', 'satisfactory intervention condition', 'incidence of major patient movement requiring rescue muscle relaxant']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0155730', 'cui_str': 'Cerebral aneurysm, nonruptured'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0235062', 'cui_str': 'Induction of neuromuscular blockade'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0428701', 'cui_str': 'Post-tetanic count'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0026827', 'cui_str': 'Decreased muscle tone'}]",58.0,0.137455,"The frequency of each ICRS score was significantly different between the groups (ICRS 5/4/3/2/1: 23/5/0/0/0 vs 15/9/2/3/0, p=0.035).","[{'ForeName': 'Bo Young', 'Initials': 'BY', 'LastName': 'Kim', 'Affiliation': 'Graduate School, Department of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Sung Hoon', 'Initials': 'SH', 'LastName': 'Chung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Seong-Joo', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Sung-Hee', 'Initials': 'SH', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'O-Ki', 'Initials': 'OK', 'LastName': 'Kwon', 'Affiliation': 'Department of Neurosurgery, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Jun-Young', 'Initials': 'JY', 'LastName': 'Jung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, College of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Jin-Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea anesing1@snu.ac.kr.'}]",Journal of neurointerventional surgery,['10.1136/neurintsurg-2020-015947']
1605,32416495,Changing the future: An initial test of Future Specificity Training (FeST).,"A range of psychiatric disorders are characterised by impairments in episodic future thinking (EFT), and particularly simulating specific, spatiotemporally-located future events. No study has examined whether training can lead to sustained improvement in specific EFT. In this study, participants (N = 60; M age = 31, SD = 13.2) were randomized to a two-session, group-based future thinking program (Future Specificity Training; FeST) or wait-list. At follow-up the training group, relative to wait-list, showed large, statistically-significant improvements in the ability to mentally simulate specific EFT (d = .82), increases in detail (d = 1.32), use of mental imagery (d = 1.32), anticipated (d = 1.78) and anticipatory pleasure (d = 1.07), perceived control (d = 1.20), and likelihood of occurrence (d = 1.09). Some effects were also observed on positive, generalised future self-states. In the context of inherent limitations of subjective reporting in trials, this study provides evidence that EFT specificity can be enhanced, and the effects of FeST indicate a possible avenue to disrupt psychopathological processes.",2020,"At follow-up the training group, relative to wait-list, showed large, statistically-significant improvements in the ability to mentally simulate specific EFT (d = .82), increases in detail (","['participants (N\xa0=\xa060; M age\xa0=\xa031, SD\xa0=\xa013.2']","['group-based future thinking program (Future Specificity Training; FeST) or wait-list', 'Future Specificity Training (FeST']","['anticipatory pleasure', 'detail ', 'ability to mentally simulate specific EFT']","[{'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}]",,0.0143698,"At follow-up the training group, relative to wait-list, showed large, statistically-significant improvements in the ability to mentally simulate specific EFT (d = .82), increases in detail (","[{'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Hallford', 'Affiliation': 'School of Psychology, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125, Melbourne, Australia. Electronic address: david.hallford@deakin.edu.au.'}, {'ForeName': 'J J E', 'Initials': 'JJE', 'LastName': 'Yeow', 'Affiliation': 'School of Psychology, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125, Melbourne, Australia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fountas', 'Affiliation': 'School of Psychology, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125, Melbourne, Australia.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Herrick', 'Affiliation': 'School of Psychology, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125, Melbourne, Australia.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Raes', 'Affiliation': 'Faculty of Psychology and Educational Sciences, KU Leuven, Tiensestraat 102, Box 3712, 3000, Leuven, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': ""D'Argembeau"", 'Affiliation': 'Psychology and Neuroscience of Cognition Research Unit, Department of Psychology, University of Liège, Belgium and Fonds de La Recherche Scientifique (F.R.S.-FNRS), Belgium.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103638']
1606,32416442,"Acute inspiratory muscle exercise effect on glucose levels, glucose variability and autonomic control in patients with type 2 diabetes: A crossover randomized trial.","Inspiratory muscle exercise (IME) can be an alternative to conventional exercise. We aimed to evaluate the effect of IME on glucose, glucose variability, and autonomic cardiovascular control in type 2 diabetes. Fourteen diabetic subjects were randomly assigned to IME with 2% maximal inspiratory pressure (PImax) or 60% PImax wearing a continuous glucose monitoring system for three days. Glucose variability [glucose variance (VAR), glucose coefficient of variation (CV%), glucose standard deviation (SD), and mean amplitude of glycemic excursions (MAGE)] were evaluated. Glucose reduction was observed in 5 min (60% of PImax 33.2% and 2% of PImax 32.0%), 60 min (60% of PImax 29.6% and 2% of PImax 31.4%) and 120 min (60% of PImax 21.4% and 2% of PImax 24.0%) after IME (vs.1 h before the exercise), with no difference between loads. This reduction in glucose levels was observed in all moments of the IME protocol. Glucose variability was reduced after 12 h and 18 h of the IME (ΔCV: P < 0.001, ΔSD: P < 0.001 and ΔVAR: P < 0.001) for both loads. No difference was found in MAGE (P = 0.594) after IME. Mean arterial pressure and heart rate rose during the exercise session with 60% of PImax. Although sufficiently strong to induce cardiovascular changes, an inspiratory muscle exercise session with 60% of PImax in subjects with type 2 diabetes has failed to induce any significant improvement in glucose, glucose variability and autonomic control, compared to the 2% Plmax exercise session.",2020,"Glucose variability was reduced after 12 h and 18 h of the IME (ΔCV: P < 0.001, ΔSD:","['2 diabetes', 'subjects with type 2 diabetes', 'Fourteen diabetic subjects', 'type 2 diabetes', 'patients with type']","['Acute inspiratory muscle exercise', 'Inspiratory muscle exercise (IME', 'IME with 2% maximal inspiratory pressure (PImax) or 60% PImax wearing a continuous glucose monitoring system', 'IME']","['glucose, glucose variability and autonomic control', 'Glucose reduction', 'MAGE', 'Glucose variability [glucose variance (VAR), glucose coefficient of variation (CV%), glucose standard deviation (SD), and mean amplitude of glycemic excursions (MAGE', 'Mean arterial pressure and heart rate', 'glucose, glucose variability, and autonomic cardiovascular control', 'glucose levels', 'Glucose variability', 'glucose levels, glucose variability and autonomic control']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}]",14.0,0.0238522,"Glucose variability was reduced after 12 h and 18 h of the IME (ΔCV: P < 0.001, ΔSD:","[{'ForeName': 'Andressa S O', 'Initials': 'ASO', 'LastName': 'Schein', 'Affiliation': 'Postgraduate Program in Cardiology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil; Exercise Pathophysiology Research Laboratory, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil. Electronic address: andressasilveiradeoliveira@yahoo.com.br.'}, {'ForeName': 'Ana P S', 'Initials': 'APS', 'LastName': 'Corrêa', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia.'}, {'ForeName': 'Aline C P', 'Initials': 'ACP', 'LastName': 'Macedo', 'Affiliation': 'Postgraduate Program in Endocrinology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil; Exercise Pathophysiology Research Laboratory, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Daniela R', 'Initials': 'DR', 'LastName': 'Dartora', 'Affiliation': 'Sainte-Justine University Hospital Research Center, University of Montreal Depatment of pediatrics, Montreal, Quebec, Canada.'}, {'ForeName': 'Anderson Donelli', 'Initials': 'AD', 'LastName': 'da Silveira', 'Affiliation': 'Postgraduate Program in Cardiology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Mateus Dornelles', 'Initials': 'MD', 'LastName': 'Severo', 'Affiliation': 'Postgraduate Program in Endocrinology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Karina R', 'Initials': 'KR', 'LastName': 'Casali', 'Affiliation': 'Institute of Science and Technology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Beatriz D', 'Initials': 'BD', 'LastName': 'Schaan', 'Affiliation': 'Postgraduate Program in Cardiology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil; Postgraduate Program in Endocrinology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil; Exercise Pathophysiology Research Laboratory, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; Department of Internal Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}]",Autonomic neuroscience : basic & clinical,['10.1016/j.autneu.2020.102669']
1607,32415365,Tranexamic acid safely reduces hidden blood loss in patients undergoing intertrochanteric fracture surgery: a randomized controlled trial.,"PURPOSE


To investigate the efficacy and safety of intravenous tranexamic acid (IV-TXA) in patients undergoing intertrochanteric fracture surgery.
METHODS


A total of 122 patients were included in this double-blinded trial and equally randomized to receive 1 g of IV-TXA or normal saline 10 min before incision and 3 h later. The primary efficacy outcome was calculated hidden blood loss (HBL). The secondary efficacy outcome was allogeneic erythrocyte transfusion rate during hospitalization. Safety outcome was a composite of thromboembolic events including deep venous thrombosis (DVT) up to 90 days. A meta-analysis combining this study with previous randomized controlled trials in hip fracture surgery (total sample size: 1112 patients) was also conducted.
RESULTS


The mean HBL in TXA group (640.96 ± 421.63 ml) was significantly lower than that in placebo group (1010.11 ± 398.96 ml, P < 0.001). The rate of erythrocyte transfusions was 29.5% in TXA group and 60.7% in placebo group (P = 0.001). The incidence of thromboembolic events at 90 days was 4.9% in TXA group and 1.6% in placebo group (P = 0.619). The updated meta-analysis showed that IV-TXA significantly reduced erythrocyte transfusion in hip fracture surgery (risk ratio 0.60, 95% confidence intervals 0.53-0.68), and IV-TXA caused no increased risk of thromboembolic events (risk difference 0.01, 95% confidence intervals - 0.02-0.04).
CONCLUSION


IV-TXA could effectively reduce the HBL and allogeneic erythrocyte transfusion requirements in patients undergoing intertrochanteric fracture surgery without an increase of thromboembolic events including DVT.
TRIAL REGISTRATION


Clinical trials: safety and efficiency of tranexamic acid in hip fracture patients. Date of registration: August 31, 2018.
TRIAL REGISTRATION NUMBER


ChiCTR1800018110.",2020,The rate of erythrocyte transfusions was 29.5% in TXA group and 60.7% in placebo group (P = 0.001).,"['hip fracture patients', 'A total of 122 patients', 'hip fracture surgery (total sample size: 1112 patients', 'patients undergoing intertrochanteric fracture surgery']","['TXA', 'intravenous tranexamic acid (IV-TXA', 'IV-TXA', 'Tranexamic acid safely', 'IV-TXA or normal saline 10\xa0min before incision and 3\xa0h later', 'tranexamic acid', 'placebo']","['HBL and allogeneic erythrocyte transfusion requirements', 'erythrocyte transfusion in hip fracture surgery', 'risk of thromboembolic events', 'allogeneic erythrocyte transfusion rate during hospitalization', 'efficacy and safety', 'calculated hidden blood loss (HBL', 'hidden blood loss', 'mean HBL', 'incidence of thromboembolic events', 'rate of erythrocyte transfusions', 'thromboembolic events', 'composite of thromboembolic events including deep venous thrombosis (DVT']","[{'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0162385', 'cui_str': 'Intertrochanteric fracture'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205262', 'cui_str': 'Occult'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}]",122.0,0.668854,The rate of erythrocyte transfusions was 29.5% in TXA group and 60.7% in placebo group (P = 0.001).,"[{'ForeName': 'Shaoyun', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, The Third Hospital of Mianyang, Sichuan Mental Health Center, No. 190 The East Jiannan Road, Mianyang, 621000, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Xiao', 'Affiliation': 'Department of Orthopedics, The Third Hospital of Mianyang, Sichuan Mental Health Center, No. 190 The East Jiannan Road, Mianyang, 621000, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Orthopedics, The Third Hospital of Mianyang, Sichuan Mental Health Center, No. 190 The East Jiannan Road, Mianyang, 621000, China.'}, {'ForeName': 'Nengji', 'Initials': 'N', 'LastName': 'Long', 'Affiliation': 'Department of Orthopedics, The Third Hospital of Mianyang, Sichuan Mental Health Center, No. 190 The East Jiannan Road, Mianyang, 621000, China.'}, {'ForeName': 'Fenglai', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'Department of Orthopedics, The Third Hospital of Mianyang, Sichuan Mental Health Center, No. 190 The East Jiannan Road, Mianyang, 621000, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Cai', 'Affiliation': 'Department of Orthopedics, The Third Hospital of Mianyang, Sichuan Mental Health Center, No. 190 The East Jiannan Road, Mianyang, 621000, China.'}, {'ForeName': 'Kairong', 'Initials': 'K', 'LastName': 'Luo', 'Affiliation': 'Department of Orthopedics, The Third Hospital of Mianyang, Sichuan Mental Health Center, No. 190 The East Jiannan Road, Mianyang, 621000, China.'}, {'ForeName': 'Yishan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Orthopedics, The Third Hospital of Mianyang, Sichuan Mental Health Center, No. 190 The East Jiannan Road, Mianyang, 621000, China. jiangysh@126.com.'}]",European journal of trauma and emergency surgery : official publication of the European Trauma Society,['10.1007/s00068-020-01387-0']
1608,32414901,Methylphenidate Effects on Cortical Thickness in Children and Adults with Attention-Deficit/Hyperactivity Disorder: A Randomized Clinical Trial.,"BACKGROUND AND PURPOSE


Although methylphenidate is frequently used to treat children with attention-deficit/hyperactivity disorder, it is currently unknown how methylphenidate affects brain development. In a randomized controlled trial, we investigated whether the cortical effects of methylphenidate are modulated by age.
MATERIALS AND METHODS


Between June 1, 2011, and June 15, 2015, we conducted a randomized, double-blind, placebo-controlled trial (Effects of Psychotropic Drugs on Developing Brain-Methylphenidate) in 99 males with attention-deficit/hyperactivity disorder (according to  Diagnostic and Statistical Manual of Mental Disorders, 4th Edition , criteria) from referral centers in the greater Amsterdam area in the Netherlands. The trial was registered on March 24, 2011 (identifier NL34509.000.10) and subsequently at the Netherlands National Trial Register (identifier NTR3103). Participants (first enrolled October 13, 2011) were 10-12 years or 23-40 years of age and randomized to treatment with either methylphenidate or a placebo for 16 weeks. Our main outcome was a change in cortical thickness in predefined ROIs as measured by MR imaging pre- and posttreatment.
RESULTS


We observed a time × medication × age interaction ( F [1,88.825] = 4.316,  P  < .05) for the right medial cortex ROI, where methylphenidate treatment yielded less cortical thinning in children, but not in adults or the placebo groups.
CONCLUSIONS


Our finding that the effects of methylphenidate on right medial cortical thickness differ between children and adults infers that the drug affects gray matter development in this brain region. This warrants replication in larger groups with longer follow-up to determine whether this effect can also be observed in other cortical brain regions and whether it may have long-term consequences.",2020,"We observed a time × medication × age interaction ( F [1,88.825] = 4.316,  P  < .05) for the right medial cortex ROI, where methylphenidate treatment yielded less cortical thinning in children, but not in adults or the placebo groups.
","['children with attention-deficit/hyperactivity disorder', 'Children and Adults with Attention-Deficit/Hyperactivity Disorder', 'Participants (first enrolled October 13, 2011) were 10-12\u2009years or 23-40\u2009years of age and randomized to treatment with either', '99 males with attention-deficit/hyperactivity disorder (according to  Diagnostic and Statistical Manual of Mental Disorders, 4th Edition , criteria) from referral centers in the greater Amsterdam area in the Netherlands']","['methylphenidate', 'Methylphenidate', 'Psychotropic Drugs', 'methylphenidate or a placebo', 'placebo']","['Cortical Thickness', 'right medial cortical thickness', 'cortical thinning', 'cortical thickness in predefined ROIs', 'Developing Brain-Methylphenidate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}]",99.0,0.743922,"We observed a time × medication × age interaction ( F [1,88.825] = 4.316,  P  < .05) for the right medial cortex ROI, where methylphenidate treatment yielded less cortical thinning in children, but not in adults or the placebo groups.
","[{'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Walhovd', 'Affiliation': 'From the Department of Psychology (K.B.W., I.A., D.A.R., A.B., A.M.F.), Center for Lifespan Changes in Brain and Cognition.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Amlien', 'Affiliation': 'From the Department of Psychology (K.B.W., I.A., D.A.R., A.B., A.M.F.), Center for Lifespan Changes in Brain and Cognition.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schrantee', 'Affiliation': 'Department of Radiology and Nuclear Medicine (A.S., A.B., L.R.), Amsterdam UMC, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Rohani', 'Affiliation': 'From the Department of Psychology (K.B.W., I.A., D.A.R., A.B., A.M.F.), Center for Lifespan Changes in Brain and Cognition.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Groote', 'Affiliation': 'Diagnostic Physics (I.G., A.B.), Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bjørnerud', 'Affiliation': 'From the Department of Psychology (K.B.W., I.A., D.A.R., A.B., A.M.F.), Center for Lifespan Changes in Brain and Cognition.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Fjell', 'Affiliation': 'From the Department of Psychology (K.B.W., I.A., D.A.R., A.B., A.M.F.), Center for Lifespan Changes in Brain and Cognition.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Reneman', 'Affiliation': 'Department of Radiology and Nuclear Medicine (A.S., A.B., L.R.), Amsterdam UMC, Academic Medical Center, Amsterdam, the Netherlands. l.reneman@amsterdamumc.nl.'}]",AJNR. American journal of neuroradiology,['10.3174/ajnr.A6560']
1609,32415423,The Effect of Therapeutic Touch on the Comfort and Anxiety of Nursing Home Residents.,"Nurses are increasingly using energy therapies such as therapeutic touch (TT) in many countries. This research aimed at finding out the effects of TT on comfort and anxiety of nursing home residents. This research is a quasi-experimental randomized control study which was conducted to investigate the impact of TT on the comfort and anxiety of older people living in a nursing home in İzmir, Turkey, between August 2015 and 2016. The sample of the study was formed from 60 older people who fitted the selection criteria, 30 in the experimental group and 30 in the control group. Data were collected using a General Comfort Questionnaire (GCQ) and a Situational Anxiety Inventory (STAI). A statistically significant difference was found between the measurements of the TT and control groups. According to the results, TT reduces anxiety and increases the comfort level of older people (p < 0.05). Considering the positive results of TT on comfort levels and anxiety, it can be recommended as an independent nursing practice.",2020,"According to the results, TT reduces anxiety and increases the comfort level of older people (p < 0.05).","['Nursing Home Residents', 'nursing home residents', '60 older people who fitted the selection criteria, 30 in the experimental group and 30 in the control group', 'older people living in a nursing home in İzmir, Turkey, between August 2015 and 2016']",['TT'],"['comfort level of older people', 'General Comfort Questionnaire (GCQ) and a Situational Anxiety Inventory (STAI']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]","[{'cui': 'C0152054', 'cui_str': 'Touch'}]","[{'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0262377', 'cui_str': 'Situational anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",,0.0398354,"According to the results, TT reduces anxiety and increases the comfort level of older people (p < 0.05).","[{'ForeName': 'Fethiye Yelkin', 'Initials': 'FY', 'LastName': 'Alp', 'Affiliation': 'Dokuz Eylul University, Nursing Faculty, Balcova, İzmir, Turkey. fethiyeyalp@gmail.com.'}, {'ForeName': 'Sebnem Cinar', 'Initials': 'SC', 'LastName': 'Yucel', 'Affiliation': 'Ege University, Nursing Faculty, Bornova, İzmir, Turkey.'}]",Journal of religion and health,['10.1007/s10943-020-01025-4']
1610,32415309,[Improve Hip Fracture Outcome In The Elderly Patient (iHOPE): a multicentre randomized controlled trial to test the efficacy of spinal versus general anaesthesia].,,2020,,['Elderly Patient'],['spinal versus general anaesthesia'],['Hip Fracture Outcome'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0763614,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kowark', 'Affiliation': 'Klinik für Anästhesiologie, Universitätsklinikum RWTH Aachen, Pauwelsstr.\xa030, 52074, Aachen, Deutschland. akowark@ukaachen.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Der Anaesthesist,['10.1007/s00101-020-00785-8']
1611,32415211,Comparison of the use of opioids only and pregabalin add-on for the treatment of neuropathic pain in cervical myelopathy patients: a pilot trial.,"Among patients with cervical myelopathy who were diagnosed with neuropathic pain (NP) by the LANSS test, the study participants were randomly assigned to one of the two study groups. The participants in one study group received opioids only, while those in the other group received opioids and pregabalin. Thirty-nine patients were analyzed in the study (20 patients in the opioid-only group and 19 in the pregabalin add-on group). The LANSS, neck pain, and arm pain scores in the pregabalin add-on group improved significantly compared with those in the opioid-only group after the first 4 weeks (p = 0.005, 0.001 and 0.035, respectively), but there was no significant difference between the two groups during the next 4 weeks (p = 0.615, 0.377 and 0.716, respectively). There was no significant difference in the neck disability index and EuroQol-5Dimension scores after four weeks and eight weeks of follow-up. Adverse events were reported by four patients (20.0%) in the opioid-only group and five patients (26.3%) in the pregabalin add-on group (p = 0.716). However, over time, the occurrence of side effects and dropouts increased in the pregabalin add-on group. This exploratory pilot study suggests that pregabalin add-on treatment is more efficient than the use of opioids alone at the beginning of NP treatment in cervical myelopathy patients. However, prescribing pregabalin add-on treatment for more than four weeks should be done cautiously.",2020,There was no significant difference in the neck disability index and EuroQol-5Dimension scores after four weeks and eight weeks of follow-up.,"['cervical myelopathy patients', 'patients with cervical myelopathy who were diagnosed with neuropathic pain (NP) by the LANSS test, the study participants', 'Thirty-nine patients were analyzed in the study (20 patients in the opioid-only group and 19 in the pregabalin add-on group']","['opioids only and pregabalin', 'pregabalin', 'opioids', 'opioids and pregabalin']","['LANSS, neck pain, and arm pain scores', 'neuropathic pain', 'neck disability index and EuroQol-5Dimension scores', 'Adverse events']","[{'cui': 'C0149645', 'cui_str': 'Cervical myelopathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}]","[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0239377', 'cui_str': 'Pain in upper limb'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",39.0,0.0383874,There was no significant difference in the neck disability index and EuroQol-5Dimension scores after four weeks and eight weeks of follow-up.,"[{'ForeName': 'Jong-Myung', 'Initials': 'JM', 'LastName': 'Jung', 'Affiliation': 'Department of Neurosurgery, Spine Center, Gachon University Gil Medical Center, Incheon, Republic of Korea.'}, {'ForeName': 'Chun Kee', 'Initials': 'CK', 'LastName': 'Chung', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea. chungc@snu.ac.kr.'}, {'ForeName': 'Chi Heon', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Heon', 'Initials': 'SH', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yunhee', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Division of Medical Statistics, Medical Research Collaborating Center, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}]",Scientific reports,['10.1038/s41598-020-65108-8']
1612,32415616,Secure Delivery of HIV-Related and Tuberculosis Laboratory Results to Patient Cell Phones: A Pilot Comparative Study.,"South Africa processes 5.1 million HIV CD4, viral load (VL), and tuberculosis (TB) tests annually. This pilot non-randomized trial in South Africa explored an intervention (""MatlaMobile"") to deliver laboratory results via mobile phone. Adults completing CD4, VL, and/or TB laboratory tests were enrolled-either receiving results by returning to clinic (control, n = 174) or mobile phone (intervention, n = 226). Study staff instructed control participants to return within 6 days (standard-of-care). MatlaMobile instructed intervention participants with clinically actionable results requiring intervention or treatment change (i.e., < 200 CD4 cells per milliliter, ≥ 400 viral copies per milliliter, or TB positive) to return immediately. A greater proportion of intervention participants than controls saw their results within 7 days of enrollment (73% vs. 8.6%, p < 0.001). Among participants instructed to return, more intervention participants (20%, n = 14/70) returned than controls (8.6%, n = 15/174, p = 0.02). MatlaMobile demonstrated that patients can quickly receive and respond appropriately to digital delivery of health information.",2020,"This pilot non-randomized trial in South Africa explored an intervention (""MatlaMobile"") to deliver laboratory results via mobile phone.","['Adults completing CD4, VL, and/or TB laboratory tests were enrolled-either receiving results by returning to clinic (control, n\u2009=\u2009174) or mobile phone (intervention, n\u2009=\u2009226', 'Patient Cell Phones']","['intervention (""MatlaMobile']","['viral load (VL), and tuberculosis (TB']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1136359', 'cui_str': 'Cellular Phone'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}]",,0.0944,"This pilot non-randomized trial in South Africa explored an intervention (""MatlaMobile"") to deliver laboratory results via mobile phone.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'DiAndreth', 'Affiliation': 'Johns Hopkins School of Nursing, 525 N Wolfe St., Baltimore, MD, 21205, USA.'}, {'ForeName': 'Brooke A', 'Initials': 'BA', 'LastName': 'Jarrett', 'Affiliation': 'Johns Hopkins School of Public Health, Johns Hopkins University, 615 North Wolfe Street, Baltimore, MD, 21205, USA. brooke@jhmi.edu.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Elf', 'Affiliation': 'Colorado State University, 1681 Campus Delivery, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Thamanna', 'Initials': 'T', 'LastName': 'Nishath', 'Affiliation': 'Johns Hopkins School of Public Health, Johns Hopkins University, 615 North Wolfe Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Brennan', 'Initials': 'B', 'LastName': 'Donville', 'Affiliation': 'Johns Hopkins School of Arts and Sciences, 3400 N. Charles Street, Baltimore, MD, 21218, USA.'}, {'ForeName': 'Omeid', 'Initials': 'O', 'LastName': 'Heidari', 'Affiliation': 'Johns Hopkins School of Nursing, 525 N Wolfe St., Baltimore, MD, 21205, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cox', 'Affiliation': 'Johns Hopkins School of Public Health, Johns Hopkins University, 615 North Wolfe Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Moreton', 'Affiliation': 'Tshimologong, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Aveer', 'Initials': 'A', 'LastName': 'Ramnath', 'Affiliation': 'Tshimologong, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Limakatso', 'Initials': 'L', 'LastName': 'Lebina', 'Affiliation': 'Perinatal HIV Research Unit (PHRU), SA MRC Soweto Matlosana Collaborating Centre for HIV/AIDS and TB, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Variava', 'Affiliation': 'Perinatal HIV Research Unit (PHRU), SA MRC Soweto Matlosana Collaborating Centre for HIV/AIDS and TB, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Golub', 'Affiliation': 'Johns Hopkins School of Public Health, Johns Hopkins University, 615 North Wolfe Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Neil A', 'Initials': 'NA', 'LastName': 'Martinson', 'Affiliation': 'Perinatal HIV Research Unit (PHRU), SA MRC Soweto Matlosana Collaborating Centre for HIV/AIDS and TB, University of the Witwatersrand, Johannesburg, South Africa.'}]",AIDS and behavior,['10.1007/s10461-020-02912-3']
1613,32415533,Introducing 'Predictive Parenting': A Feasibility Study of a New Group Parenting Intervention Targeting Emotional and Behavioral Difficulties in Children with Autism Spectrum Disorder.,"Parent-mediated interventions can reduce behavioral and emotional problems in children with ASD. This report discusses the development of the first group parent intervention targeting behaviors and anxiety in children with ASD, across the spectrum of cognitive and language ability. 'Predictive Parenting' was developed from the clinical observation (and emerging evidence base) that children with ASD struggle with 'prediction' and anticipating change. It integrates well-established parenting strategies within an ASD-specific framework. The concept was co-created with patient and public involvement panels of parents and adults with ASD. A feasibility study found the programme is acceptable and accessible. Qualitative feedback from participants was largely positive, and critiques were used to inform a larger, pilot randomized controlled trial of the intervention.",2020,"This report discusses the development of the first group parent intervention targeting behaviors and anxiety in children with ASD, across the spectrum of cognitive and language ability. '","['Children with Autism Spectrum Disorder', 'children with ASD', ""Introducing 'Predictive Parenting""]",['New Group Parenting Intervention'],['behavioral and emotional problems'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}]",,0.0708181,"This report discusses the development of the first group parent intervention targeting behaviors and anxiety in children with ASD, across the spectrum of cognitive and language ability. '","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Hallett', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK. Victoria.hallett@slam.nhs.uk.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Mueller', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Breese', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Hollett', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Beresford', 'Affiliation': 'Social Policy Research Unit, University of York, York, UK.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Irvine', 'Affiliation': 'Social Policy Research Unit, University of York, York, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Pickles', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Slonims', 'Affiliation': ""Newcomen Neurodevelopmental Centre, Children's Neurosciences, Evelina Children's Hospital, Guy's and St Thomas NHS Foundation, London, UK.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Scott', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Charman', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Simonoff', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04442-2']
1614,32415471,Effectiveness of functional exercises on pain and sleep quality in patients with primary dysmenorrhea: a randomized clinical trial.,"PURPOSE


Primary dysmenorrhea is the most common gynecological problem in young women and adolescents. Exercise therapy provides positive effects on women with primary dysmenorrhea. The aim of the study was to investigate the effects of a combined exercise program on pain, sleep and menstrual symptoms in patients with primary dysmenorrhea.
METHODS


The study is a randomized controlled study. The study included 28 sedentary individuals. The participants were assigned to two groups as the exercise (mean age 22.9 ± 2.0 years) and the control (mean age 23.1 ± 1.8 years) groups. The exercise protocol was carried out with the exercise group three times a week for eight weeks. The Visual Analog Scale (VAS) was used for assessing the intensity of pain. The Menstrual Symptom Questionnaire (MSQ) and Pittsburgh Sleep Quality Index (PSQI) were used for evaluating menstrual symptoms and sleep quality, respectively. The study was registered on the Clinical Trials website by the number NCT03625375.
RESULTS


The comparisons between the groups revealed statistically significant differences in abdominal pain severity, MSQ total score and the subscale scores of negative outcomes and management methods (p < 0.05). The intragroup comparisons of the exercise group demonstrated that the scores of the low back pain and abdominal pain and the MSQ and PSQI scores were found to be significantly different after the 8-week program (p < 0.05).
CONCLUSION


The combined exercise therapy is an effective way to manage symptoms associated with primary dysmenorrhea.",2020,"The comparisons between the groups revealed statistically significant differences in abdominal pain severity, MSQ total score and the subscale scores of negative outcomes and management methods (p < 0.05).","['young women and adolescents', 'patients with primary dysmenorrhea', 'women with primary dysmenorrhea', '28 sedentary individuals']","['functional exercises', 'combined exercise program', 'Exercise therapy', 'combined exercise therapy']","['Visual Analog Scale (VAS', 'Menstrual Symptom Questionnaire (MSQ) and Pittsburgh Sleep Quality Index (PSQI', 'low back pain and abdominal pain and the MSQ and PSQI scores', 'pain, sleep and menstrual symptoms', 'abdominal pain severity, MSQ total score and the subscale scores of negative outcomes and management methods', 'menstrual symptoms and sleep quality', 'pain and sleep quality']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",28.0,0.0352192,"The comparisons between the groups revealed statistically significant differences in abdominal pain severity, MSQ total score and the subscale scores of negative outcomes and management methods (p < 0.05).","[{'ForeName': 'Berkiye', 'Initials': 'B', 'LastName': 'Kirmizigil', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Eastern Mediterranean University, Famagusta, North Cyprus, via Mersin-10, Turkey. berkiye.kirmizigil@emu.edu.tr.'}, {'ForeName': 'Cisel', 'Initials': 'C', 'LastName': 'Demiralp', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Eastern Mediterranean University, Famagusta, North Cyprus, via Mersin-10, Turkey.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05579-2']
1615,32415610,Randomized clinical trial of a novel donor-derived cfDNA test to detect rejection in CPV-simulated renal transplant patients.,"PURPOSE


Five-year kidney graft loss currently stands at about 30%. We evaluate the clinical utility of a blood test measuring donor-derived cell-free DNA that detects rejection earlier and, potentially, improves diagnostic and therapeutic accuracy.
METHODS


In a randomized controlled experiment, we measured the clinical practice of 175 practicing nephrologists, both with and without the use of dd-cfDNA testing. Providers cared for six simulated post-renal transplant patient cases whose ages ranged from 30 to 75 years and were 3-24 months post-transplant with typical presentations.
RESULTS


154 nephrologists completed two rounds of simulated cases. At baseline, the study arms performed similarly, demonstrating no significant differences either in primary diagnosis (p = 0.853), decisions to biopsy or refer to transplant center (p = 1.000), or therapeutic management (p = 0.488). After introduction of the dd-cfDNA test, intervention nephrologists were more likely to arrive at the diagnosis of rejection (OR 4.00, 95% CI 1.93-8.30), make a correct decision on biopsy/transplant center referral (OR 11.07, 95% CI 4.87-25.16), and properly adjust therapeutic management (OR 2.37, 95% CI 1.07-5.24).
CONCLUSION


A sample of nationally representative, practicing nephrologists given dd-cfDNA to evaluate post-transplant patients were more likely to correctly diagnose early and subclinical allograft rejection, to send for biopsy or refer to transplant center, and to appropriately change treatment than those nephrologists without dd-cfDNA access.",2020,"At baseline, the study arms performed similarly, demonstrating no significant differences either in primary diagnosis (p = 0.853), decisions to biopsy or refer to transplant center (p = 1.000), or therapeutic management (p = 0.488).","['CPV-simulated renal transplant patients', '154 nephrologists completed two rounds of simulated cases', '175 practicing nephrologists, both with and without the use of dd-cfDNA testing', 'Providers cared for six simulated post-renal transplant patient cases whose ages ranged from 30 to 75\xa0years and were 3-24\xa0months post-transplant with typical presentations']","['novel donor-derived cfDNA test', 'blood test measuring donor-derived cell-free DNA']","['correct decision on biopsy/transplant center referral', 'decisions to biopsy or refer to transplant center']","[{'cui': 'C0006893', 'cui_str': 'Cape Verde islands'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0260039', 'cui_str': 'Nephrologist'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C4289789', 'cui_str': 'Cell free DNA'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C4289789', 'cui_str': 'Cell free DNA'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]",,0.0283824,"At baseline, the study arms performed similarly, demonstrating no significant differences either in primary diagnosis (p = 0.853), decisions to biopsy or refer to transplant center (p = 1.000), or therapeutic management (p = 0.488).","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Peabody', 'Affiliation': 'School of Medicine, University of California, 450 Pacific Ave, Suite 200, San Francisco, CA, 94133, USA. jpeabody@qurehealthcare.com.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Billings', 'Affiliation': 'Natera, Inc, San Carlos, CA, USA.'}, {'ForeName': 'Czarlota', 'Initials': 'C', 'LastName': 'Valdenor', 'Affiliation': 'QURE Healthcare, San Francisco, CA, USA.'}, {'ForeName': 'Zach', 'Initials': 'Z', 'LastName': 'Demko', 'Affiliation': 'Natera, Inc, San Carlos, CA, USA.'}, {'ForeName': 'Solomon', 'Initials': 'S', 'LastName': 'Moshkevich', 'Affiliation': 'Natera, Inc, San Carlos, CA, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Tran', 'Affiliation': 'QURE Healthcare, San Francisco, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Paculdo', 'Affiliation': 'QURE Healthcare, San Francisco, CA, USA.'}]",International urology and nephrology,['10.1007/s11255-020-02491-1']
1616,32415555,Pulmonary vein isolation using second-generation single-shot devices: not all the same?,"INTRODUCTION


Single-shot devices have been developed to simplify pulmonary vein isolation (PVI). Randomized studies of the second-generation cryoballoon (CB 2nd) demonstrated excellent results. There are limited data comparing results of circular pulmonary vein ablation catheter (PVAC) with conventional RF ablation or CB for PVI.
OBJECTIVE


Using a sequential registry cohort and a prospective randomized study, we aimed to compare the acute and long-term results of CB 2nd and PVAC Gold.
METHODS


In the registry, consecutive patients with paroxysmal atrial fibrillation (AF) undergoing their first PVI were included. The preferred method used was PVAC Gold in 2014 and CB 2nd in 2015. Subsequently, a randomized study (PVAC vs. CB 2nd) was performed. Ablation success was measured as freedom of AF or atrial tachycardias (AT) off antiarrhythmic drugs.
RESULTS


In the registry cohort, PVAC Gold was used in 60 patients and CB 2nd in 56 patients (age 66 ± 11 years, 52% male, LAD 43 ± 6). In the randomized study, 20 patients were treated with PVAC Gold and 22 with CB 2nd (age 67 ± 9; 43% men, LAD 40 ± 7 mm). During a mean follow up of 13.2 ± 3.6 months, success was 54% in PVAC Gold patients and 81% in CB 2nd cases (p = 0.001). In the randomized study 12 months success was 50% versus 86%, p < 0.05. Complications occurred rare in both groups.
CONCLUSIONS


Our registry data and the randomized study both suggest superiority of PVI using CB 2nd as compared with PVI using PVAC Gold.",2020,"In the randomized study 12 months success was 50% versus 86%, p < 0.05.","['20 patients were treated with PVAC Gold and 22 with CB 2nd (age 67\u2009±\u20099; 43% men, LAD 40\u2009±\u20097\xa0mm', '60 patients and CB 2nd in 56 patients (age 66\u2009±\u200911\xa0years, 52% male, LAD 43\u2009±\u20096', 'consecutive patients with paroxysmal atrial fibrillation (AF) undergoing their first PVI were included']","['Pulmonary vein isolation using second-generation single-shot devices', 'CB 2nd and PVAC Gold', 'circular pulmonary vein ablation catheter (PVAC) with conventional RF ablation']","['Ablation success', 'Complications', 'freedom of AF or atrial tachycardias (AT) off antiarrhythmic drugs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0226032', 'cui_str': 'Structure of anterior descending branch of left coronary artery'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C1282913', 'cui_str': 'Circular'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}]",20.0,0.0750098,"In the randomized study 12 months success was 50% versus 86%, p < 0.05.","[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Seidl', 'Affiliation': 'Clinic for Cardiology/Department for Interventional Electrophysiology, Helios Hospital Erfurt, Nordhäuser Str. 74, 99089, Erfurt, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Steinborn', 'Affiliation': 'Clinic for Cardiology/Department for Interventional Electrophysiology, Helios Hospital Erfurt, Nordhäuser Str. 74, 99089, Erfurt, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Costello-Boerrigter', 'Affiliation': 'Helios Research Center, Erfurt, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Surber', 'Affiliation': 'Department of Internal Medicine I/Cardiology, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Schulze', 'Affiliation': 'Department of Internal Medicine I/Cardiology, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Böttcher', 'Affiliation': 'Clinic for Cardiology/Department for Interventional Electrophysiology, Helios Hospital Erfurt, Nordhäuser Str. 74, 99089, Erfurt, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Sommermeier', 'Affiliation': 'Clinic for Cardiology/Department for Interventional Electrophysiology, Helios Hospital Erfurt, Nordhäuser Str. 74, 99089, Erfurt, Germany.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Mattea', 'Affiliation': 'Clinic for Cardiology/Department for Interventional Electrophysiology, Helios Hospital Erfurt, Nordhäuser Str. 74, 99089, Erfurt, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Simeoni', 'Affiliation': 'Clinic for Cardiology/Department for Interventional Electrophysiology, Helios Hospital Erfurt, Nordhäuser Str. 74, 99089, Erfurt, Germany.'}, {'ForeName': 'Frank Michael', 'Initials': 'FM', 'LastName': 'Malur', 'Affiliation': 'Clinic for Cardiology/Department for Interventional Electrophysiology, Helios Hospital Erfurt, Nordhäuser Str. 74, 99089, Erfurt, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Lapp', 'Affiliation': 'Clinic for Cardiology/Department for Interventional Electrophysiology, Helios Hospital Erfurt, Nordhäuser Str. 74, 99089, Erfurt, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Schade', 'Affiliation': 'Clinic for Cardiology/Department for Interventional Electrophysiology, Helios Hospital Erfurt, Nordhäuser Str. 74, 99089, Erfurt, Germany. anja.schade@helios-gesundheit.de.'}]",Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing,['10.1007/s10840-020-00751-9']
1617,32415664,Neuronal Biomarkers in Predicting Neurodevelopmental Outcome in Term Babies with Perinatal Asphyxia.,"OBJECTIVE


To assess whether serum levels of neuronal biomarkers (S100 calcium-binding protein B and Neuron specific enolase) correlate with the neurodevelopmental outcome of term neonates at 18 mo who had hypoxic ischemic encephalopathy and underwent therapeutic hypothermia.
METHODS


This randomized controlled trial was conducted in a tertiary care teaching hospital, south India. There were 162 term infants with moderate to severe hypoxic ischemic encephalopathy who were randomized into 2 groups (Group A and B). Neonates in Group A and B received normothermia and therapeutic hypothermia respectively. Serum levels of neuronal biomarkers were estimated at 0, 24 (±1) and 72 (±1) h after birth using sandwich ELISA in both groups. All neonates were carefully monitored till discharge. Infants who survived the neonatal period were followed up in the high risk clinic for 18 mo and neurodevelopmental assessment was done using Developmental Assessment Scale for Indian Infants (DASII). Neurodevelopmental outcomes between the two groups were compared using Chi square test and neuronal biomarker levels between the groups were compared using Mann Whitney test.
RESULTS


The baseline maternal and neonatal characteristics in both groups were comparable. There was statistically insignificant lesser mortality in therapeutic hypothermia group compared to normothermia group with Risk Ratio (RR): 0.82 (28.2% vs. 34.5%, 95% CI: 0.52-1.29, p = 0.38). Among the survivors, children in therapeutic hypothermia group had better motor and mental scores compared to those in normothermia group at 18 mo. There was no significant correlation between S100B and Neuron specific enolase levels and neurodevelopmental outcome.
CONCLUSIONS


Serum levels of neuronal biomarkers (S100B and Neuron specific enolase) do not correlate with the long term neurodevelopmental outcome among these infants.",2020,"Among the survivors, children in therapeutic hypothermia group had better motor and mental scores compared to those in normothermia group at 18 mo.","['162 term infants with moderate to severe hypoxic ischemic encephalopathy', 'Term Babies with Perinatal Asphyxia', 'term neonates at 18 mo who had hypoxic ischemic encephalopathy and underwent therapeutic hypothermia', 'tertiary care teaching hospital, south India']",[],"['Chi square test and neuronal biomarker levels', 'baseline maternal and neonatal characteristics', 'S100B and Neuron specific enolase levels and neurodevelopmental outcome', 'Neurodevelopmental outcomes', 'motor and mental scores', 'mortality', 'Serum levels of neuronal biomarkers']","[{'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic ischemic encephalopathy'}, {'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0559477', 'cui_str': 'Perinatal asphyxia'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0021201', 'cui_str': 'India'}]",[],"[{'cui': 'C0008041', 'cui_str': 'Chi-Square Test'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",162.0,0.0912209,"Among the survivors, children in therapeutic hypothermia group had better motor and mental scores compared to those in normothermia group at 18 mo.","[{'ForeName': 'R Christina', 'Initials': 'RC', 'LastName': 'Catherine', 'Affiliation': 'Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'B Vishnu', 'Initials': 'BV', 'LastName': 'Bhat', 'Affiliation': 'Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India. drvishnubhat@yahoo.com.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Adhisivam', 'Affiliation': 'Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'Shruthi K', 'Initials': 'SK', 'LastName': 'Bharadwaj', 'Affiliation': 'Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'Vickneshwaran', 'Initials': 'V', 'LastName': 'Vinayagam', 'Affiliation': 'Department of Biochemistry, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}, {'ForeName': 'Palanivel', 'Initials': 'P', 'LastName': 'Chinnakali', 'Affiliation': 'Department of Preventive & Social Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}]",Indian journal of pediatrics,['10.1007/s12098-020-03283-2']
1618,32415575,"Ixekizumab and Ustekinumab Efficacy in Nail Psoriasis in Patients with Moderate-to-Severe Psoriasis: 52-Week Results from a Phase 3, Head-to-Head Study (IXORA-S).","INTRODUCTION


Patients with plaque psoriasis often have nail psoriasis, which is difficult to treat. Ixekizumab (IXE) and ustekinumab (UST) are biologics with established efficacy in nail psoriasis. We present post hoc data from a head-to-head trial of IXE and UST (IXORA-S) to examine the efficacy in nail psoriasis in patients with moderate-to-severe plaque psoriasis over 52 weeks.
METHODS


In IXORA-S,  randomised patients received IXE (N = 136) or UST (N = 166) per label for 52 weeks. Eighty-four (61.8%) and 105 (63.3%) of the patients treated with IXE or UST, respectively, had baseline fingernail psoriasis (Nail Psoriasis Severity Index [NAPSI] > 0); of these, 54 (64.3%) and 63 (60.0%) patients, respectively, had significant baseline fingernail psoriasis (defined as NAPSI ≥ 16 with ≥ 4 fingernails involved). The proportion of patients achieving NAPSI = 0, a NAPSI score change from baseline and correlations in Psoriasis Area of Severity Index (PASI) and NAPSI improvement over 52 weeks were examined.
RESULTS


Progressive improvement occurred in both treatment groups over 52 weeks. Statistically significantly more patients achieved NAPSI = 0 with IXE versus UST by week 16-20, and the proportions continued to increase through week 52 among patients with baseline nail psoriasis (61.9 vs. 28.6%, respectively; P < 0.001), including those with significant nail psoriasis (57.4 vs. 17.5%, respectively; P < 0.001). Similar results were observed for NAPSI score improvement from baseline to week 52. Interestingly, the presence of nail psoriasis was associated with lower skin response with UST but not with IXE.
CONCLUSIONS


Ixekizumab was superior to UST in the clearance of nail psoriasis, with earlier improvement continued through 52 weeks regardless of baseline nail severity.
TRIAL REGISTRATION


ClinicalTrials.gov identifier; NCT02561806.",2020,Ixekizumab (IXE) and ustekinumab (UST) are biologics with established efficacy in nail psoriasis.,"['patients with moderate-to-severe plaque psoriasis over 52\xa0weeks', 'Patients with plaque psoriasis often have nail psoriasis', 'nail psoriasis', 'Nail Psoriasis in Patients with Moderate-to-Severe Psoriasis']","['IXE and UST (IXORA-S', 'IXE or UST', 'IXE', 'Ixekizumab', 'Ixekizumab (IXE) and ustekinumab (UST', 'UST']","['Psoriasis Area of Severity Index (PASI) and NAPSI improvement', 'nail psoriasis', 'NAPSI score improvement', 'baseline fingernail psoriasis (Nail Psoriasis Severity Index [NAPSI', 'Progressive improvement', 'skin response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0406322', 'cui_str': 'Psoriasis of nail'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0406322', 'cui_str': 'Psoriasis of nail'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0222001', 'cui_str': 'Fingernails'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0312646', 'cui_str': 'Finding related to response to skin test'}]",,0.0802576,Ixekizumab (IXE) and ustekinumab (UST) are biologics with established efficacy in nail psoriasis.,"[{'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wasel', 'Affiliation': 'Stratica Medical and Probity Medical Research, Edmonton, AB, Canada. nwasel@straticamedical.com.'}, {'ForeName': 'Diamant', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Research Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Lars E', 'Initials': 'LE', 'LastName': 'French', 'Affiliation': 'Department of Dermatology and Allergy, University Hospital, Ludwig Maximilian University of Munich (LMU Munich), Munich, Germany.'}, {'ForeName': 'Curdin', 'Initials': 'C', 'LastName': 'Conrad', 'Affiliation': 'Department of Dermatology, Lausanne University Hospital (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Dutronc', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Lovisa', 'Initials': 'L', 'LastName': 'Berggren', 'Affiliation': 'HaaPACS GmbH, Schriesheim, Germany.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': ""Department of Dermatology, University Hospital of Nice-Côte d'Azur, Nice, France.""}]",Dermatology and therapy,['10.1007/s13555-020-00383-x']
1619,32415720,"The First-in-Human Study of CNTO 7160, an Anti-Interleukin-33 Receptor Monoclonal Antibody, in Healthy Subjects and Patients with Asthma or Atopic Dermatitis.","AIMS


Assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of CNTO 7160, an anti-interleukin-33 receptor (IL-33R) monoclonal antibody, in healthy subjects and patients with asthma or atopic dermatitis (AD).
METHODS


In Part 1 of this Phase I, randomized, double-blind, placebo-controlled study, healthy subjects (n=68) received single ascending intravenous (IV) CNTO 7160 dose (0.001 to 10 mg kg -1  ) or placebo. In Part 2, patients with mild asthma (n=24) or mild AD (n=15) received three biweekly IV CNTO 7160 doses (3 or 10 mg kg -1  ) or placebo.
RESULTS


CNTO 7160 was generally well tolerated, with one serious adverse event of severe cellulitis reported (AD, CNTO 7160 3 mg kg -1  ). CNTO 7160 exhibited non-linear PK (0.01 to 10 mg kg -1  ). Mean clearance decreased with increasing dose (2.43 to 18.03 mL day -1  kg -1  ). CNTO 7160 PK was similar between healthy subjects and patients with asthma or AD (3 or 10 mg kg -1  ). Free sIL-33R suppression was rapid and dose-dependent. Ex-vivo inhibition of p38 phosphorylation of basophils was dose-dependent (1 to 10 mg kg -1  ) and sustained inhibition (≥75%) was observed at higher doses (3 or 10 mg kg -1  ). PK/PD modelling and simulation suggests that 1 mg/kg IV every 2 weeks provides adequate systemic drug exposure for sustained inhibition of p38 phosphorylation of basophils. Despite confirmation of target engagement, no apparent CNTO 7160 clinical activity was observed in patients (asthma or AD).
CONCLUSION


This first-in-human study provides PK, PD, and safety data, supporting further clinical investigation of CNTO 7160 in patients with asthma and AD.",2020,Ex-vivo inhibition of p38 phosphorylation of basophils was dose-dependent (1 to 10 mg kg -1  ) and sustained inhibition (≥75%) was observed at higher doses (3 or 10 mg kg -1  ).,"['healthy subjects and patients with asthma or AD', 'patients (asthma or AD', 'healthy subjects (n=68) received', 'patients with asthma and AD', 'healthy subjects and patients with asthma or atopic dermatitis (AD', 'patients with mild asthma (n=24) or mild AD (n=15', 'Healthy Subjects and Patients with Asthma or Atopic Dermatitis']","['single ascending intravenous (IV) CNTO', 'placebo']","['safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity', 'Mean clearance', 'Free sIL-33R suppression']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0257766', 'cui_str': 'SILV protein, human'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",7160.0,0.162099,Ex-vivo inhibition of p38 phosphorylation of basophils was dose-dependent (1 to 10 mg kg -1  ) and sustained inhibition (≥75%) was observed at higher doses (3 or 10 mg kg -1  ).,"[{'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Nnane', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Frederick', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Zhenling', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Raible', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Cathye', 'Initials': 'C', 'LastName': 'Shu', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Badorrek', 'Affiliation': 'Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Clinical Airway Research, Nikolai-Fuchs-Strasse 1, 30625, Hannover, Germany.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'van den Boer', 'Affiliation': 'Janssen Research & Development LLC, Merksem, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Branigan', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Duffy', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Baribaud', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Fink', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Tong-Yuan', 'Initials': 'TY', 'LastName': 'Yang', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.14361']
1620,32415684,"Clopidogrel, a CYP2C8 inhibitor, causes a clinically relevant increase in the systemic exposure to the active metabolite of selexipag in healthy subjects.","AIMS


Selexipag is a prostacyclin receptor agonist approved for the treatment of pulmonary arterial hypertension. Cytochrome P450 (CYP) 2C8 is involved in the metabolism of selexipag and its active metabolite, ACT-333679. This study evaluated the interaction of selexipag and clopidogrel, a CYP2C8 inhibitor.
METHODS


The study had a two-treatment, one-sequence, crossover design. Pharmacokinetics (PK) and CYP2C8 genotype were assessed in healthy male subjects administered selexipag (200 μg twice daily (b.i.d.)) alone or with clopidogrel (300 mg single dose or 75 mg once daily (o.d.)). PK modelling and simulation were conducted to support dosing recommendations.
RESULTS


Clopidogrel had a comparatively small effect on selexipag (< 1.5-fold difference in any PK variable). For ACT-333679, the major contributor to the drug effect, the area under the plasma concentration-time curve during a dose interval (AUC τ  ) and the maximum plasma concentration (C max  ) increased 2.25-fold (90% confidence interval (CI) 2.06, 2.46) and 1.69-fold (90% CI 1.55, 1.84), respectively with clopidogrel 300 mg and 2.70-fold (90% CI 2.45, 2.96) and 1.90-fold (90% CI 1.72, 2.11), respectively with clopidogrel 75 mg. The effect of clopidogrel on selexipag and ACT-333679 exposure was comparable for all identified CYP2C8 genotypes. PK simulations predicted comparable exposure to ACT-333679 following selexipag 400 μg b.i.d., 400 μg o.d. in combination with clopidogrel 75 mg o.d and 200 μg b.i.d. with clopidogrel 75 mg o.d.
CONCLUSION


Results suggest that ACT-333679 exposure can be maintained within the therapeutic range by reducing selexipag dosing frequency to o.d. or dose to half, when selexipag is coadministered with clopidogrel.",2020,The effect of clopidogrel on selexipag and ACT-333679 exposure was comparable for all identified CYP2C8 genotypes.,"['pulmonary arterial hypertension', 'healthy male subjects administered', 'healthy subjects']","['selexipag', 'selexipag and clopidogrel, a CYP2C8 inhibitor', 'clopidogrel', 'clopidogrel 75 mg o.d', 'Clopidogrel']","['Pharmacokinetics (PK) and CYP2C8 genotype', 'maximum plasma concentration (C max  ', 'plasma concentration-time curve', 'selexipag']","[{'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C2000145', 'cui_str': 'selexipag'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C3850061', 'cui_str': 'P450 CYP2C8 Inhibitors'}, {'cui': 'C1124675', 'cui_str': 'clopidogrel 75 MG'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1382144', 'cui_str': 'Cytochrome p450 CYP2C8 enzyme'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C2000145', 'cui_str': 'selexipag'}]",,0.0966444,The effect of clopidogrel on selexipag and ACT-333679 exposure was comparable for all identified CYP2C8 genotypes.,"[{'ForeName': 'Lene Nygaard', 'Initials': 'LN', 'LastName': 'Axelsen', 'Affiliation': 'Department of Clinical Pharmacology, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Italo', 'Initials': 'I', 'LastName': 'Poggesi', 'Affiliation': 'Department of Clinical Pharmacology, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Freya', 'Initials': 'F', 'LastName': 'Rasschaert', 'Affiliation': 'Clinical Pharmacology Unit, Janssen Pharmaceutica NV, Merksem, Belgium.'}, {'ForeName': 'Juan Jose', 'Initials': 'JJ', 'LastName': 'Perez Ruixo', 'Affiliation': 'Department of Clinical Pharmacology, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Bruderer', 'Affiliation': 'Department of Clinical Pharmacology, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.'}]",British journal of clinical pharmacology,['10.1111/bcp.14365']
1621,32415721,"Effect of Screening, Brief Intervention and Referral to Treatment for Unhealthy Alcohol and Other Drug Use in Mental Health Treatment Settings: A Randomised Controlled Trial.","AIMS


To test the efficacy of a brief intervention to reduce alcohol or drug use and to promote use of addiction services among patients seeking mental health treatment.
DESIGN AND SETTING


A multi-centre, longitudinal, two-group randomised controlled trial with randomisation within each of two mental health treatment systems located in Ventura County and Los Angeles County in California, USA PARTICIPANTS: A total of 718 patients (49.2% female) aged 18 and older with a mental health diagnosis and either a heavy drinking day or any use of cannabis or stimulants in the past 90 days.
INTERVENTION AND COMPARATOR


A motivation-based brief intervention with personalized feedback (Screening, Brief Intervention and Referral to Treatment (SBIRT) condition) (n=354) or a health education session (control condition) (n=364).
MEASUREMENTS


Primary outcomes included frequency of heavy drinking days, days of cannabis use and days of stimulant use at the primary endpoint 3 months post baseline. Secondary outcomes included frequency and abstinence from substance use out to a 12-month follow up and the use of addiction treatment services.
FINDINGS


Participants in the SBIRT condition had fewer heavy drinking days (odds ratio = 0.53; 95% CrI 0.48-0.6) and fewer days of stimulant use (odds ratio = 0.58; 95% CrI 0.50-0.66) at the 3-month follow-up compared with participants in the health education condition. Participants in the SBIRT condition did not comparatively reduce days of cannabis use at the 3-month follow-up (odds ratio = 0.93; 95% CrI 0.85-1.01). Secondary outcomes indicated sustained effects of SBIRT on reducing the frequency of heavy drinking days and days of stimulant use. No effects were observed on abstinence rates or use of addiction treatment services.
CONCLUSIONS


Screening and brief intervention for unhealthy alcohol and drug use in mental health treatment settings were effective at reducing the frequency of heavy drinking and stimulant use.",2020,Participants in the SBIRT condition did not comparatively reduce days of cannabis use at the 3-month follow-up (odds ratio = 0.93; 95% CrI 0.85-1.01).,"['718 patients (49.2% female) aged 18 and older with a mental health diagnosis and either a heavy drinking day or any use of cannabis or stimulants in the past 90 days', 'Mental Health Treatment Settings', 'A multi-centre, longitudinal, two-group randomised controlled trial with randomisation within each of two mental health treatment systems located in Ventura County and Los Angeles County in California, USA PARTICIPANTS', 'patients seeking mental health treatment']","['AND COMPARATOR\n\n\nA motivation-based brief intervention with personalized feedback (Screening, Brief Intervention and Referral to Treatment (SBIRT) condition) (n=354) or a health education session (control condition']","['abstinence rates or use of addiction treatment services', 'frequency of heavy drinking days, days of cannabis use and days of stimulant use', 'heavy drinking days', 'frequency and abstinence from substance use out to a 12-month follow up and the use of addiction treatment services', 'sustained effects of SBIRT on reducing the frequency of heavy drinking days and days of stimulant use']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",718.0,0.0866086,Participants in the SBIRT condition did not comparatively reduce days of cannabis use at the 3-month follow-up (odds ratio = 0.93; 95% CrI 0.85-1.01).,"[{'ForeName': 'Mitchell P', 'Initials': 'MP', 'LastName': 'Karno', 'Affiliation': 'University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences, Integrated Substance Abuse Programs, 11075 Santa Monica Blvd., Suite 200, Los Angeles, CA, 90025, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rawson', 'Affiliation': 'University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences, Integrated Substance Abuse Programs, 11075 Santa Monica Blvd., Suite 200, Los Angeles, CA, 90025, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Rogers', 'Affiliation': 'University of California, Los Angeles, Department of Biostatistics and School of Nursing, 650 Charles E. Young Dr. South, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Spear', 'Affiliation': 'California State University Northridge, Department of Health Sciences, 18111 Nordhoff St, Northridge, CA, 91330, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Grella', 'Affiliation': 'University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences, Integrated Substance Abuse Programs, 11075 Santa Monica Blvd., Suite 200, Los Angeles, CA, 90025, USA.'}, {'ForeName': 'Larissa J', 'Initials': 'LJ', 'LastName': 'Mooney', 'Affiliation': 'University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences, Integrated Substance Abuse Programs, 11075 Santa Monica Blvd., Suite 200, Los Angeles, CA, 90025, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Saitz', 'Affiliation': 'Boston University School of Public Health, Department of Community Health Sciences, 801 Massachusetts Avenue 4th Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Kagan', 'Affiliation': 'University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences, 757 Westwood Plaza, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Glasner', 'Affiliation': 'University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences, Integrated Substance Abuse Programs, 11075 Santa Monica Blvd., Suite 200, Los Angeles, CA, 90025, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15114']
1622,32415802,The Effects of Canagliflozin compared to Sitagliptin on Cardiorespiratory Fitness in Type 2 Diabetes Mellitus and Heart Failure with Reduced Ejection Fraction: Results of the CANA-HF Study.,"BACKGROUND


Canagliflozin reduces hospitalizations for heart failure (HF) in type 2 diabetes mellitus (T2DM). Its effect on cardiorespiratory fitness (CRF) and cardiac function in patients with established HF with reduced ejection fraction (HFrEF) is unknown.
METHODS


We conducted a double blinded randomized controlled trial of canagliflozin 100 mg or sitagliptin 100 mg daily for 12 weeks in 88 patients, and measured peak oxygen consumption (VO 2  ) and minute ventilation/carbon dioxide production (VE/VCO 2  ) slope (co-primary endpoints for repeated measure ANOVA time_x_group interaction), lean peak VO 2  , ventilatory anaerobic threshold (VAT), cardiac function and quality of life (ie, Minnesota Living with Heart Failure Questionnaire [MLHFQ]), at baseline and 12-week follow-up.
RESULTS


The study was terminated early due to the new guidelines recommending canagliflozin over sitagliptin in HF: 17 patients were assigned to canagliflozin and 19 to sitagliptin, total of 36 patients. There were no significant changes in peak VO 2  and VE/VCO 2  slope between the 2 groups (P = 0.083 and P = 0.98, respectively). Canagliflozin improved lean peak VO 2  (+2.4 mL•kg LM   -1  •min -1  , P = 0.036), VAT (+1.5 mL•kg -1  •min -1  , P = 0.012), and VO 2  matched for respiratory exchange ratio (+2.4 mL•Kg -1  •min -1  , P = 0.002) compared to sitagliptin. Canagliflozin also reduced MLHFQ score (-12.1, P = 0.018).
CONCLUSIONS


In this small and short-term study of patients with T2DM and HFrEF, interrupted early after only 36 patients, canagliflozin did not improve the primary endpoints of peak VO 2  or VE/VCO 2  slope compared to sitagliptin, while showing favorable trends observed on several additional surrogate endpoints such as lean peak VO 2  , VAT and quality of life. This article is protected by copyright. All rights reserved.",2020,"Canagliflozin also reduced MLHFQ score (-12.1, P = 0.018).
","['patients with established HF with reduced ejection fraction (HFrEF', 'type 2 diabetes mellitus (T2DM', 'Type 2 Diabetes Mellitus and Heart Failure with Reduced Ejection Fraction']","['canagliflozin 100\u2009mg or sitagliptin', 'Sitagliptin', 'Canagliflozin', 'canagliflozin']","['cardiorespiratory fitness (CRF) and cardiac function', 'peak oxygen consumption (VO 2  ) and minute ventilation/carbon dioxide production (VE/VCO 2  ) slope (co-primary endpoints for repeated measure ANOVA time_x_group interaction), lean peak VO 2  , ventilatory anaerobic threshold (VAT), cardiac function and quality of life (ie, Minnesota Living with Heart Failure Questionnaire [MLHFQ', 'peak VO 2  and VE/VCO 2  slope', 'lean peak VO', 'VAT', 'MLHFQ score', 'lean peak VO 2  , VAT and quality of life', 'peak VO 2  or VE/VCO 2  slope', 'Cardiorespiratory Fitness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C3556569', 'cui_str': 'canagliflozin 100 MG [Invokana]'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0002780', 'cui_str': 'Analysis, Variance'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042427', 'cui_str': 'Vatican City'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",36.0,0.0961832,"Canagliflozin also reduced MLHFQ score (-12.1, P = 0.018).
","[{'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Carbone', 'Affiliation': 'Department of Kinesiology & Health Sciences, College of Humanities & Sciences, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Hayley E', 'Initials': 'HE', 'LastName': 'Billingsley', 'Affiliation': 'Department of Kinesiology & Health Sciences, College of Humanities & Sciences, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Canada', 'Affiliation': 'VCU Pauley Heart Center, Division of Cardiology, Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Bressi', 'Affiliation': 'VCU Pauley Heart Center, Division of Cardiology, Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Brando', 'Initials': 'B', 'LastName': 'Rotelli', 'Affiliation': 'VCU Pauley Heart Center, Division of Cardiology, Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Kadariya', 'Affiliation': 'VCU Pauley Heart Center, Division of Cardiology, Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Dave L', 'Initials': 'DL', 'LastName': 'Dixon', 'Affiliation': 'Department of Pharmacotherapy and & Outcomes Science, School of Pharmacy, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Roshanak', 'Initials': 'R', 'LastName': 'Markley', 'Affiliation': 'VCU Pauley Heart Center, Division of Cardiology, Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Cory R', 'Initials': 'CR', 'LastName': 'Trankle', 'Affiliation': 'VCU Pauley Heart Center, Division of Cardiology, Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Cooke', 'Affiliation': 'VCU Pauley Heart Center, Division of Cardiology, Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Krishnasree', 'Initials': 'K', 'LastName': 'Rao', 'Affiliation': 'VCU Pauley Heart Center, Division of Cardiology, Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Keyur', 'Initials': 'K', 'LastName': 'Shah', 'Affiliation': 'VCU Pauley Heart Center, Division of Cardiology, Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Horacio Medina', 'Initials': 'HM', 'LastName': 'de Chazal', 'Affiliation': 'VCU Pauley Heart Center, Division of Cardiology, Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Juan Guido', 'Initials': 'JG', 'LastName': 'Chiabrando', 'Affiliation': 'VCU Pauley Heart Center, Division of Cardiology, Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Vecchié', 'Affiliation': 'VCU Pauley Heart Center, Division of Cardiology, Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Dell', 'Affiliation': 'VCU Pauley Heart Center, Division of Cardiology, Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Mihalick', 'Affiliation': 'VCU Pauley Heart Center, Division of Cardiology, Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Bogaev', 'Affiliation': 'Advanced Heart Failure Center, Bon Secours Heart & Vascular Institute, Richmond, Virginia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Hart', 'Affiliation': 'Advanced Heart Failure Center, Bon Secours Heart & Vascular Institute, Richmond, Virginia.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Van Tassell', 'Affiliation': 'Department of Pharmacotherapy and & Outcomes Science, School of Pharmacy, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Arena', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, Illinois, Department of Physical Therapy, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Francesco S', 'Initials': 'FS', 'LastName': 'Celi', 'Affiliation': 'Division of Endocrinology Diabetes and Metabolism, Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Abbate', 'Affiliation': 'VCU Pauley Heart Center, Division of Cardiology, Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia.'}]",Diabetes/metabolism research and reviews,['10.1002/dmrr.3335']
1623,32415824,Effectiveness of yogic visual concentration (Trataka) on cognitive performance and anxiety among adolescents.,"Background Cognition is the mental process of acquiring knowledge, understanding senses and synchronizing all the electrical activity that is constantly received and generated through the eye. Purpose of the present study was to assess the effectiveness of yogic visual concentration (Trataka) on cognitive performance and anxiety among adolescents studying in selected schools at Chennai. Methodology This study was designed to assess cognitive performance and anxiety among students using quantitative approach. True Experimental study design was used for this study. Pretest assessment of cognitive performance and anxiety was done by standardized tools (Stroop color word test, Hamilton anxiety scale) for Experimental and Control groups. Intervention of yogic visual concentration (Trataka) was experimented in one group. Control group were kept on routine activities. Post test assessment of cognitive performance and anxiety by standardized tools was performed on experimental and control groups. The data were analyzed by descriptive statistics and inferential statistics. The 0.05 level of significance was used. Results A significant difference in the mean difference of color word score, color score, word score and inference score between the study and control groups at the level of p<0.0001 was observed. Results indicate an association in the cognitive performance (word) with background variables such as, gender, father's occupation in the study group during the post test and no association in the control group. There were no associations between anxiety cognitive performance (color and word) and demographic variables in both groups. Conclusion The study concluded that there is a greater effect on Yogic visual concentration (Trataka) on cognitive performance and anxiety among adolescent students, therefore the study proved the hypothesis.",2020,"The study concluded that there is a greater effect on Yogic visual concentration (Trataka) on cognitive performance and anxiety among adolescent students, therefore the study proved the hypothesis.","['adolescents studying in selected schools at Chennai', 'students using quantitative approach', 'adolescents', 'adolescent students']",['yogic visual concentration (Trataka'],"['standardized tools (Stroop color word test, Hamilton anxiety scale', 'anxiety cognitive performance (color and word) and demographic variables', 'yogic visual concentration (Trataka', 'cognitive performance (word', 'Yogic visual concentration (Trataka) on cognitive performance and anxiety', 'mean difference of color word score, color score, word score and inference score', 'cognitive performance and anxiety']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0582675', 'cui_str': 'Stroop neuropsychological screening test'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0238278,"The study concluded that there is a greater effect on Yogic visual concentration (Trataka) on cognitive performance and anxiety among adolescent students, therefore the study proved the hypothesis.","[{'ForeName': 'J Ida', 'Initials': 'JI', 'LastName': 'Sherlee', 'Affiliation': 'Sri Ramachandra Medical College and Research Institute, Chennai, Tamil Nadu 600116, India.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'David', 'Affiliation': 'Sri Ramachandra Medical College and Research Institute, Chennai, Tamil Nadu 600116, India.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2019-0055']
1624,32415885,"UV308 excimer lamp phototherapy for the treatment of alopecia areata: A randomized, self-controlled study.","Alopecia areata (AA) defined as non-cicatricial alopecia, which is postulated as hair-specific autoimmune rejection of an unknown component of the hair follicle. Currently, very little evidence-based data are available for AA treatment, and no treatment provides satisfactory results consistently. Excimer lamp (e-lamp) therapy is a new long-wave monochromatic ultraviolet (UV)B phototherapy that only targets affected areas.",2020,Excimer lamp (e-lamp) therapy is a new long-wave monochromatic ultraviolet (UV)B phototherapy that only targets affected areas.,['alopecia areata'],"['UV308 excimer lamp phototherapy', 'Excimer lamp (e-lamp) therapy']",['Alopecia areata (AA'],"[{'cui': 'C0002170', 'cui_str': 'Alopecia'}]","[{'cui': 'C0392223', 'cui_str': 'Lamp'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0002170', 'cui_str': 'Alopecia'}]",,0.0169899,Excimer lamp (e-lamp) therapy is a new long-wave monochromatic ultraviolet (UV)B phototherapy that only targets affected areas.,"[{'ForeName': 'Pongpenn', 'Initials': 'P', 'LastName': 'Sirichotiyakul', 'Affiliation': 'Division of dermatology, Chulabhorn international college of medicine, Thammasat University, Pathum Thani, 12120, Thailand.'}, {'ForeName': 'Jitlada', 'Initials': 'J', 'LastName': 'Meephansan', 'Affiliation': 'Division of dermatology, Chulabhorn international college of medicine, Thammasat University, Pathum Thani, 12120, Thailand.'}, {'ForeName': 'Poonkiat', 'Initials': 'P', 'LastName': 'Suchonwanit', 'Affiliation': 'Division of Dermatology, Faculty of Medicine, Ramathibodi Hospital, Bangkok, 10400, Thailand.'}]","Photodermatology, photoimmunology & photomedicine",['10.1111/phpp.12570']
1625,31140654,Reduced burden of diabetes and improved quality of life: Experiences from unrestricted day-and-night hybrid closed-loop use in very young children with type 1 diabetes.,"OBJECTIVE


To evaluate the experiences of families with very young children aged 1 to 7 years (inclusive) with type 1 diabetes using day-and-night hybrid closed-loop insulin delivery.
METHODS


Parents/caregivers of 20 children aged 1 to 7 years with type 1 diabetes completed a closed-loop experience survey following two 3-week periods of unrestricted day-and-night hybrid closed-loop insulin therapy using Cambridge FlorenceM system at home. Benefits, limitations, and improvements of closed-loop technology were explored.
RESULTS


Responders reported reduced burden of diabetes management, less time spent managing diabetes, and improved quality of sleep with closed-loop. Ninety percent of the responders felt less worried about their child's glucose control using closed-loop. Size of study devices, battery performance and connectivity issues were identified as areas for improvement. Parents/caregivers wished for more options to input information to the system such as temporary glucose targets.
CONCLUSIONS


Parents/caregivers of very young children reported important quality of life benefits associated with using closed-loop, supporting adoption of this technology in this population.",2019,Ninety percent of the responders felt less worried about their child's glucose control using closed-loop.,"['families with very young children aged 1 to 7 years (inclusive) with type 1 diabetes using day-and-night hybrid closed-loop insulin delivery', 'Parents/caregivers of 20 children aged 1 to 7 years with type 1 diabetes completed a closed-loop experience survey following two 3-week periods of']",['unrestricted day-and-night hybrid closed-loop insulin therapy using Cambridge FlorenceM system at home'],"['burden of diabetes and improved quality of life: Experiences', 'quality of sleep', 'burden of diabetes management, less time spent managing diabetes']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]",20.0,0.0365829,Ninety percent of the responders felt less worried about their child's glucose control using closed-loop.,"[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Musolino', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Klemen', 'Initials': 'K', 'LastName': 'Dovc', 'Affiliation': ""Department of Paediatric Endocrinology, Diabetes and Metabolic Diseases, University Children's Hospital, University Medical Centre, Ljubljana, Slovenia.""}, {'ForeName': 'Charlotte K', 'Initials': 'CK', 'LastName': 'Boughton', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Tauschmann', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Allen', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Nagl', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Fritsch', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Yong', 'Affiliation': ""Department of Paediatric Diabetes, Leeds Children's Hospital, Leeds, UK.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Metcalfe', 'Affiliation': ""Department of Paediatric Diabetes, Leeds Children's Hospital, Leeds, UK.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Schaeffer', 'Affiliation': 'Department of Pediatric Diabetes and Endocrinology, Clinique Pédiatrique, Centre Hospitalier, Luxembourg City, Luxembourg.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Fichelle', 'Affiliation': 'Department of Pediatric Diabetes and Endocrinology, Clinique Pédiatrique, Centre Hospitalier, Luxembourg City, Luxembourg.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Schierloh', 'Affiliation': 'Department of Pediatric Diabetes and Endocrinology, Clinique Pédiatrique, Centre Hospitalier, Luxembourg City, Luxembourg.'}, {'ForeName': 'Alena G', 'Initials': 'AG', 'LastName': 'Thiele', 'Affiliation': 'Division for Paediatric Diabetology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Abt', 'Affiliation': 'Department of Pediatrics I, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Kojzar', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Julia K', 'Initials': 'JK', 'LastName': 'Mader', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Slegtenhorst', 'Affiliation': 'Department of Nutrition & Dietetics, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ashcroft', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Malgorzata E', 'Initials': 'ME', 'LastName': 'Wilinska', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Sibayan', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Kollman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Sabine E', 'Initials': 'SE', 'LastName': 'Hofer', 'Affiliation': 'Department of Pediatrics I, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Fröhlich-Reiterer', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Kapellen', 'Affiliation': 'Division for Paediatric Diabetology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Carlo L', 'Initials': 'CL', 'LastName': 'Acerini', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'de Beaufort', 'Affiliation': 'Department of Pediatric Diabetes and Endocrinology, Clinique Pédiatrique, Centre Hospitalier, Luxembourg City, Luxembourg.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Campbell', 'Affiliation': ""Department of Paediatric Diabetes, Leeds Children's Hospital, Leeds, UK.""}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Rami-Merhar', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hovorka', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric diabetes,['10.1111/pedi.12872']
1626,32415846,Adjunctive sertraline for asymptomatic cryptococcal antigenemia: A randomized clinical trial.,"Cryptococcal antigen (CrAg) screening in HIV-infected persons with CD4 < 100 cells/µl can reduce meningitis and death, yet preemptive fluconazole therapy fails in ∼25%. Sertraline has in vitro and in vivo activity against Cryptococcus and is synergistic with fluconazole in mice. We evaluated the efficacy and safety of sertraline in asymptomatic cryptococcal antigenemia. We conducted a randomized trial of asymptomatic CrAg-positive Ugandans from November 2017 to February 2018. All subjects received WHO standard therapy of fluconazole 800 mg for 2 weeks, then 400 mg for 10 weeks, then 200 mg through 24 weeks. Participants were randomized to receive adjunctive sertraline or placebo, given in once-weekly escalating 100 mg/day doses up to 400 mg/day, which was then given for 8 weeks, then tapered. The primary endpoint was meningitis-free 6-month survival. The data and safety monitoring board halted the trial after 21 subjects were enrolled due to safety concerns. Meningitis-free 6-month survival occurred in 9 of 11 of placebo participants and 10 of 10 of sertraline participants. However, seven serious adverse events (SAEs) occurred (n = 4 sertraline group; n = 3 placebo group). Three SAEs in the sertraline group presented with psychosis and aggressive behavioral changes with one meeting Hunter's criteria for serotonin syndrome while receiving 200 mg/day sertraline. Two transient psychoses were associated with antecedent fluconazole and sertraline interruption. The serotonin syndrome resolved within 1 day, but psychosis persisted for 4 months after sertraline discontinuation. Sertraline was associated with excess SAEs of psychosis. Due to early stopping, we were unable to determine any efficacy for cryptococcal antigenemia.",2020,Meningitis-free 6-month survival occurred in 9 of 11 of placebo participants and 10 of 10 of sertraline participants.,"['HIV-infected persons with CD4', 'asymptomatic cryptococcal antigenemia', 'asymptomatic CrAg-positive Ugandans from November 2017 to February 2018', '21 subjects were enrolled due to safety concerns']","['fluconazole', 'sertraline', 'adjunctive sertraline or placebo', 'Sertraline', 'Adjunctive sertraline', 'placebo']","['meningitis-free 6-month survival', 'efficacy and safety', 'meningitis and death', 'Meningitis-free 6-month survival']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0010415', 'cui_str': 'Cryptococcus'}, {'cui': 'C0522281', 'cui_str': 'Cryptococcal antigen'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]","[{'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0025289', 'cui_str': 'Meningitis'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",21.0,0.245246,Meningitis-free 6-month survival occurred in 9 of 11 of placebo participants and 10 of 10 of sertraline participants.,"[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Nalintya', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Uganda.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kirumira', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Uganda.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Naluyima', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Uganda.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Turya', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Uganda.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Namanda', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Uganda.'}, {'ForeName': 'Morris K', 'Initials': 'MK', 'LastName': 'Rutakingirwa', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Uganda.'}, {'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Yofesi', 'Initials': 'Y', 'LastName': 'Nikweri', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute & London School of Hygiene and Tropical Medicine (MRC/UVRI & LSHTM), Uganda Research Unit, Masaka Station.'}, {'ForeName': 'Kathy Huppler', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Meya', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}]",Medical mycology,['10.1093/mmy/myaa033']
1627,31566666,Combination gemcitabine plus S-1 versus gemcitabine plus cisplatin for advanced/recurrent biliary tract cancer: the FUGA-BT (JCOG1113) randomized phase III clinical trial.,"BACKGROUND


Gemcitabine plus cisplatin (GC) is the standard treatment of advanced biliary tract cancer (BTC); however, it causes nausea, vomiting, and anorexia, and requires hydration. Gemcitabine plus S-1 (GS) reportedly has equal to, or better, efficacy and an acceptable toxicity profile. We aimed to confirm the non-inferiority of GS to GC for patients with advanced/recurrent BTC in terms of overall survival (OS).
PATIENTS AND METHODS


We undertook a phase III randomized trial in 33 institutions in Japan. Eligibility criteria included chemotherapy-naïve patients with recurrent or unresectable BTC, an Eastern Cooperative Oncology Group Performance Status of 0 - 1, and adequate organ function. The calculated sample size was 350 with a one-sided α of 5%, a power of 80%, and non-inferiority margin hazard ratio (HR) of 1.155. The primary end point was OS, while the secondary end points included progression-free survival (PFS), response rate (RR), adverse events (AEs), and clinically significant AEs defined as grade ≥2 fatigue, anorexia, nausea, vomiting, oral mucositis, or diarrhea.
RESULTS


Between May 2013 and March 2016, 354 patients were enrolled. GS was found to be non-inferior to GC [median OS: 13.4 months with GC and 15.1 months with GS, HR, 0.945; 90% confidence interval (CI), 0.78-1.15; P = 0.046 for non-inferiority]. The median PFS was 5.8 months with GC and 6.8 months with GS (HR 0.86; 95% CI 0.70-1.07). The RR was 32.4% with GC and 29.8% with GS. Both treatments were generally well-tolerated. Clinically significant AEs were observed in 35.1% of patients in the GC arm and 29.9% in the GS arm.
CONCLUSIONS


GS, which does not require hydration, should be considered a new, convenient standard of care option for patients with advanced/recurrent BTC.
CLINICAL TRIAL NUMBER


This trial has been registered with the UMIN Clinical Trials Registry (http://www.umin.ac.jp/ctr/index.htm), number UMIN000010667.",2019,"The median PFS was 5.8 months with GC and 6.8 months with GS (HR, 0.86, 95% CI, 0.70-1.07).","['Eligibility criteria included chemotherapy-naïve patients with recurrent or unresectable BTC, an Eastern Cooperative Oncology Group Performance Status of 0-1, and adequate organ function', '33 institutions in Japan', 'Between May 2013 and March 2016, 354 patients were enrolled', 'advanced/recurrent biliary tract cancer', 'patients with advanced/recurrent BTC in terms of overall survival (OS', 'advanced biliary tract cancer (BTC', 'patients with advanced/recurrent']","['Gemcitabine plus cisplatin (GC', 'Combination gemcitabine plus S-1 versus gemcitabine plus cisplatin', 'Gemcitabine plus S-1']","['progression-free survival (PFS), response rate (RR), adverse events (AEs), and clinically significant AEs defined as grade ≥2 fatigue, anorexia, nausea, vomiting, oral mucositis, or diarrhea', 'tolerated', 'median PFS']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0750952', 'cui_str': 'Biliary Tract Cancer'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",354.0,0.139934,"The median PFS was 5.8 months with GC and 6.8 months with GS (HR, 0.86, 95% CI, 0.70-1.07).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Morizane', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, Tokyo. Electronic address: cmorizan@ncc.go.jp.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Okusaka', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, Tokyo.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mizusawa', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Katayama', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ueno', 'Affiliation': 'Department of Gastroenterology, Hepatobiliary and Pancreatic Medical Oncology Division, Kanagawa Cancer Center, Yokohama.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ozaka', 'Affiliation': 'Hepato-Biliary-Pancreatic Medicine Department, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Okano', 'Affiliation': 'Department of Medical Oncology, Kyorin University Faculty of Medicine, Tokyo.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sugimori', 'Affiliation': 'Gastroenterological Center, Yokohama City University Medical Center, Yokohama.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fukutomi', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Gastroenterology, Saitama Cancer Center, Saitama.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Mizuno', 'Affiliation': 'Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yanagimoto', 'Affiliation': 'Department of Surgery, Kansai Medical University Hospital, Hirakata.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Wada', 'Affiliation': 'Department of Surgery, Teikyo University School of Medicine, Tokyo.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Tobimatsu', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine Kobe University Graduate School of Medicine, Kobe.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Yane', 'Affiliation': 'Center for Gastroenterology, Teine Keijinkai Hospital, Sapporo.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nakamori', 'Affiliation': 'Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Clinical Oncology, Jichi Medical University, Shimotsuke.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Asagi', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yukisawa', 'Affiliation': 'Department of Medical Oncology, Tochigi Cancer Center, Utsunomiya.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Kojima', 'Affiliation': 'Department of Gastroenterology, National Center for Global Health and Medicine, Tokyo.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kawabe', 'Affiliation': 'Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Kawamoto', 'Affiliation': 'Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Hepato-Biliary-Pancreatology, National Hospital Organization Kyushu Cancer Center, Fukuoka.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Iwai', 'Affiliation': 'Department of Gastroenterology, Kitasato University Hospital, Sagamihara.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Division of Gastroenterology, Chiba Cancer Center, Chiba.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Miyakawa', 'Affiliation': 'Department of Bilio-Pancreatology, Sapporo Kousei General Hospital, Sapporo.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Department of Gastroenterology, Kanazawa University, Kanazawa.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hosokawa', 'Affiliation': 'Department of Gastroenterology and Hematology, University of Toyama, Faculty of Medicine, Toyama.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ioka', 'Affiliation': 'Department of Cancer Survey and Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, Chiba University, Chiba.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Shioji', 'Affiliation': 'Department of Internal medicine, Niigata Cancer Center Hospital, Niigata.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Shimizu', 'Affiliation': ""Department of Gastroenterology, Tokyo Women's Medical University, Tokyo.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Nakagohri', 'Affiliation': 'Gastroenterological Surgery, Tokai University School of Medicine, Isehara.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kamata', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Ishii', 'Affiliation': 'Clinical Research Center, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Furuse', 'Affiliation': 'Department of Medical Oncology, Kyorin University Faculty of Medicine, Tokyo.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz402']
1628,31147367,High prevalence of hyperuricaemia and its impact on non-valvular atrial fibrillation: the cross-sectional Guangzhou (China) Heart Study.,"OBJECTIVES


There are country and regional variations in the prevalence of hyperuricaemia (HUA). The prevalence of HUA and non-valvular atrial fibrillation (NVAF) in southern China is unknown.
DESIGN


A cross-sectional study.
SETTING AND PARTICIPANTS


A total of 11 488 permanent residents aged 35 or older from urban and rural areas of Guangzhou, China were enrolled. A questionnaire was used to compile each participant's demographic information and relevant epidemiological factors for HUA and NVAF. All participants were assessed using a panel of blood tests and single-lead 24-hour ECG.
MAIN OUTCOME MEASURES


HUA was defined as serum uric acid level >420 μmol/L in men and >360 μmol/L in women. NVAF was diagnosed as per guidelines.
RESULTS


The prevalence of HUA was 39.6% (44.8% in men and 36.7% in women), and 144 residents (1.25%) had NVAF. Prevalence of HUA increased with age in women but remained stably high in men. After adjusting for potential confounders, age, living in urban areas, alcohol consumption, central obesity, elevated fasting plasma glucose level, elevated blood pressure, lower high-density lipoprotein cholesterol level and elevated triglycerides level were associated with increased risk of HUA. Residents with HUA were at higher risk for NVAF. Serum uric acid level had a modest predictive value for NVAF in women but not men.
CONCLUSIONS


HUA was highly prevalent among citizens of southern China and was a predictor of NVAF among women.",2019,"Serum uric acid level had a modest predictive value for NVAF in women but not men.
","['A total of 11\u2009488 permanent residents aged 35 or older from urban and rural areas of Guangzhou, China were enrolled']",['NVAF'],"['serum uric acid level', 'Serum uric acid level', 'living in urban areas, alcohol consumption, central obesity, elevated fasting plasma glucose level, elevated blood pressure, lower high-density lipoprotein cholesterol level and elevated triglycerides level', 'prevalence of HUA', 'prevalence of HUA and non-valvular atrial fibrillation (NVAF', 'Prevalence of HUA']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0151691', 'cui_str': 'High density lipoprotein decreased'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",11488.0,0.151714,"Serum uric acid level had a modest predictive value for NVAF in women but not men.
","[{'ForeName': 'Wei-Dong', 'Initials': 'WD', 'LastName': 'Lin', 'Affiliation': 'Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial Peoples Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial Peoples Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Pi', 'Initials': 'P', 'LastName': 'Guo', 'Affiliation': 'Department of Preventive Medicine, Shantou University Medical College, Shantou, China.'}, {'ForeName': 'Fang-Zhou', 'Initials': 'FZ', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial Peoples Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Ru-Yin', 'Initials': 'RY', 'LastName': 'Chen', 'Affiliation': 'Department of Preventive Medicine, Shantou University Medical College, Shantou, China.'}, {'ForeName': 'Xian-Hong', 'Initials': 'XH', 'LastName': 'Fang', 'Affiliation': 'Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial Peoples Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Xian-Zhang', 'Initials': 'XZ', 'LastName': 'Zhan', 'Affiliation': 'Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial Peoples Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Hong-Tao', 'Initials': 'HT', 'LastName': 'Liao', 'Affiliation': 'Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial Peoples Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Wen-Xiang', 'Initials': 'WX', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial Peoples Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial Peoples Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial Peoples Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Mu-Rui', 'Initials': 'MR', 'LastName': 'Zheng', 'Affiliation': 'Guangzhou Center for Disease Control and Prevention, Guangzhou, China.'}, {'ForeName': 'Hua-Zhang', 'Initials': 'HZ', 'LastName': 'Liu', 'Affiliation': 'Guangzhou Center for Disease Control and Prevention, Guangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial Peoples Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': 'Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial Peoples Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Yu-Mei', 'Initials': 'YM', 'LastName': 'Xue', 'Affiliation': 'Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial Peoples Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Shu-Lin', 'Initials': 'SL', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial Peoples Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.'}]",BMJ open,['10.1136/bmjopen-2018-028007']
1629,32415945,Efficacy of cefotaxime combined with gamma globulins on C-reactive protein and procalcitonin in neonatal sepsis.,"C-reactive protein (CRP) is encoded by CRP or PTX1 gene and procalcitonin (PCT) is produced by the CALC-1 gene induction. Both PCT and CRP are known as valued biomarkers markers in prediction of Serious Bacterial Infections (SBI) in children. This experiment carried out to analyze the efficacy of cefotaxime combined with gamma globulins on neonatal sepsis and the effect on CRP and PCT. For this purpose, a total of 120 sepsis children were selected and randomly divided into observation and control groups. Children in the control group were treated with cefotaxime, while children in the observation group were treated with cefotaxime combined with gamma globulins. The two groups were compared in terms of the relative measures of efficacy, the total effective rate of treatment, the incidence of complications and serum CRP and PCT levels before and after treatment. The clinical measures of the observation group were all lower than those of the control group, and the total effective rate of the treatment was higher than that of the control group, while the incidence of complications was lower than that of the control group. In addition, before treatment, there was no difference in CRP and PCT between the two groups; after treatment, the above measures in the observation group were lower than those in the control group. It is concluded that Cefotaxime combined with gamma globulins in the treatment of neonatal sepsis has significant efficacy and is clinically more effective than cefotaxime monotherapy. This combination can shorten clinical symptom remission time and hospital stay, improve serum CRP and PCT levels and promote the recovery of children, worthy of promotion.",2020,"This combination can shorten clinical symptom remission time and hospital stay, improve serum CRP and PCT levels and promote the recovery of children, worthy of promotion.","['neonatal sepsis', '120 sepsis children']","['cefotaxime', 'cefotaxime combined with gamma globulins', 'C-reactive protein (CRP', 'Cefotaxime']","['total effective rate of treatment, the incidence of complications and serum CRP and PCT levels', 'total effective rate', 'clinical symptom remission time and hospital stay, improve serum CRP and PCT levels', 'neonatal sepsis', 'incidence of complications', 'CRP and PCT']","[{'cui': 'C0456103', 'cui_str': 'Sepsis of the newborn'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0007554', 'cui_str': 'Cefotaxime'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0017007', 'cui_str': 'Gamma globulin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0456103', 'cui_str': 'Sepsis of the newborn'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}]",120.0,0.0137262,"This combination can shorten clinical symptom remission time and hospital stay, improve serum CRP and PCT levels and promote the recovery of children, worthy of promotion.","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Pediatrics, The General Hospital of PLA Central Theater Command KanKou Are, Wuhan, Hubei 430014, China.'}]","Cellular and molecular biology (Noisy-le-Grand, France)",[]
1630,31826368,Effect of exercise therapy combined with branched-chain amino acid supplementation on muscle strength in elderly women after total hip arthroplasty: a randomized controlled trial.,"BACKGROUND AND OBJECTIVES


Many patients develop a prolonged decrease of muscle strength after total hip arthroplasty (THA) despite their reconstructed hip joint. Physical exercise combined with branched-chain amino acid (BCAA) supplementation has been reported to improve muscle strength in elderly persons with sarcopenia. However, the effect of BCAA supplementation in patients after THA is unknown. This study examined the effects of BCAA supplementation combined with exercise therapy on the improvement of physical function in elderly patients after THA.
METHODS AND STUDY DESIGN


The subjects were 31 elderly women who underwent THA. The participants were randomly assigned to two groups: BCAA (n=18) and control (n=13). The combined therapy was carried out for one month after THA. For the exercise intervention, a 3-set physical exercise program was conducted. For the nutritional intervention, the participants consumed 3.4 g of BCAA supplement or 1.2 g of starch immediately after the exercise intervention.
RESULTS


BCAA supplementation combined with muscle strengthening exercises had a significant effect on knee extension strength of the contralateral side and on upper arm cross-sectional area. The improvement ratio of knee extension strength before and after intervention on the operated side was also significantly higher in the BCAA group.
CONCLUSIONS


BCAA supplementation is effective for patients to improve the strength of some muscles when combined with physical exercises, but hip abductor muscle strength of the operated leg did not improve. A future study is needed to determine the efficacy of this combined therapy for hip abductor muscle strength.",2019,"The improvement ratio of knee extension strength before and after intervention on the operated side was also significantly higher in the BCAA group.
","['elderly patients after THA', '31 elderly women who underwent THA', 'elderly women after total hip arthroplasty', 'elderly persons with sarcopenia']","['BCAA supplementation combined with exercise therapy', 'BCAA', 'Physical exercise combined with branched-chain amino acid (BCAA) supplementation', 'exercise therapy combined with branched-chain amino acid supplementation', 'BCAA supplementation combined with muscle strengthening exercises', 'exercise intervention, a 3-set physical exercise program', 'BCAA supplementation']","['muscle strength', 'improvement ratio of knee extension strength', 'physical function', 'knee extension strength']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}]","[{'cui': 'C0556085', 'cui_str': 'Branched chain amino acid supplementation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",31.0,0.0226091,"The improvement ratio of knee extension strength before and after intervention on the operated side was also significantly higher in the BCAA group.
","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ikeda', 'Affiliation': 'School of Nursing and Rehabilitation Sciences, Showa University, Yokohama, Japan. tk.ikeda@nr.showa-u.ac.jp.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Matsunaga', 'Affiliation': 'School of Nursing and Rehabilitation Sciences, Showa University, Yokohama, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Kanbara', 'Affiliation': 'School of Nursing and Rehabilitation Sciences, Showa University, Yokohama, Japan.'}, {'ForeName': 'Arinori', 'Initials': 'A', 'LastName': 'Kamono', 'Affiliation': 'School of Nursing and Rehabilitation Sciences, Showa University, Yokohama, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Masuda', 'Affiliation': 'Faculty of Symbiotic Systems Science, Fukushima University, Fukushima, Japan.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Orthopedic Surgery, Showa University Fujigaoka Hospital, Yokohama, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Nakanishi', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Showa University, Yokohama, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Jinno', 'Affiliation': 'Department of Rehabilitation Medicine, Tokyo Medical and Dental University Graduate School, Tokyo, Japan.'}]",Asia Pacific journal of clinical nutrition,['10.6133/apjcn.201912_28(4).0007']
1631,31826369,A randomized controlled trial of preoperative carbohydrate drinks on postoperative walking capacity in elective colorectal surgery.,"BACKGROUND AND OBJECTIVES


Routine overnight fasting may increase the risk of postoperative complications and delay postoperative recovery. Oral carbohydrate drinks have been shown to reduce glucose utilization and postoperative negative nitrogen balance while preserving muscle mass and strength. This randomized controlled trial aimed to examine whether preoperative oral carbohydrate drinks can enhance postoperative physical recovery in patients undergoing major colorectal surgery.
METHODS AND STUDY DESIGN


Seventy patients were randomly assigned to receive either a 12.5% oral carbohydrate drink or pure water. Patients in both groups received 800- mL of one of the drinks on the evening before surgery, and another 400-mL drink on the morning of the operative day. The primary outcomes were the distances covered in 2-minute-walk tests at 24, 48 and 72-hours and 6- minute walk tests at 7-10 days postoperatively. The secondary outcomes were the postoperative serum insulin and glucose concentrations, nitrogen balance, duration of hospital stay, and the patient satisfaction scores.
RESULTS


There were no significant differences in the characteristics of the two patients-groups. The postoperative 2-minute and 6-minute walk test distances, serum insulin and glucose concentrations of both groups were not statistically different. Patients receiving carbohydrate drink had more positive nitrogen balance than the control group. The duration of hospital stay and patient satisfaction scores were similar for both-groups.
CONCLUSIONS


There were no statistically significant differences in the postoperative walking capacities of patients receiving a carbohydrate drink or pure water; only the nitrogen balance on postoperative day 3 was higher for patients receiving the carbohydrate drink.",2019,"The postoperative 2-minute and 6-minute walk test distances, serum insulin and glucose concentrations of both groups were not statistically different.","['patients undergoing major colorectal surgery', 'elective colorectal surgery', 'Seventy patients']","['preoperative carbohydrate drinks', 'carbohydrate drink', 'oral carbohydrate drink or pure water', 'preoperative oral carbohydrate drinks', 'Oral carbohydrate drinks']","['postoperative serum insulin and glucose concentrations, nitrogen balance, duration of hospital stay, and the patient satisfaction scores', 'postoperative 2-minute and 6-minute walk test distances, serum insulin and glucose concentrations', 'distances covered in 2-minute-walk tests', 'postoperative physical recovery', 'postoperative walking capacities', 'positive nitrogen balance', 'nitrogen balance', 'duration of hospital stay and patient satisfaction scores', 'postoperative walking capacity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0429631', 'cui_str': 'Nitrogen balance'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",70.0,0.0986527,"The postoperative 2-minute and 6-minute walk test distances, serum insulin and glucose concentrations of both groups were not statistically different.","[{'ForeName': 'Mingkwan', 'Initials': 'M', 'LastName': 'Wongyingsinn', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. mingkwan.won@mahidol.ac.th.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Luangchan', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sawinee', 'Initials': 'S', 'LastName': 'Tungsongsawat', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Attaporn', 'Initials': 'A', 'LastName': 'Trakarnsanga', 'Affiliation': 'Minimally Invasive Surgery Unit, Department of Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Varut', 'Initials': 'V', 'LastName': 'Lohsiriwat', 'Affiliation': 'Colorectal Surgery Unit, Department of Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Asia Pacific journal of clinical nutrition,['10.6133/apjcn.201912_28(4).0008']
1632,31322037,Effects of Social Support and 12-Step Involvement on Recovery among People in Continuing Care for Cocaine Dependence.,"Background:  Social networks that support recovery lead to enhanced treatment outcomes and sobriety regardless if this support stems from family, peer groups or 12-Step programs. Treatment process factors including readiness to change and commitment to abstinence also impact substance use. However, little is understood about the relationship between social support to treatment process factors during and after treatment for substance use disorders.  Objectives:  To identify the ways in which different social networks foster substance use change in a sample of individuals with cocaine dependence from intensive outpatient programs (IOPs).  Methods:  Data were drawn from two studies examining adults ( N  = 489) with cocaine dependence in IOPs for substance use disorders collected between 2004 and 2009. Assessment data were collected at 3- to 6-month intervals from baseline to 24-months and included the University of Rhode Island change assessment questionnaire, timeline followback, thoughts about abstinence, perceived social support - friend, and family versions and analyzed using GEE and mediational analyses.  Results:  Greater perceived friend social support was associated with greater readiness to change whereas greater perceived familial social support was associated with substance use goal; greater social support from both friends and family were associated with less substance use. Greater AA/NA participation was associated with substance use goal and readiness to change, and less substance use. Substance use goals partially mediated the impact of social support on later substance use.  Conclusions/Importance:  While peer and familial support are key to sustained recovery, their impact differentially affects treatment process variables. This information could be used to inform social support treatment interventions.",2019,Greater perceived friend social support was associated with greater readiness to change whereas greater perceived familial social support was associated with substance use goal; greater social support from both friends and family were associated with less substance use.,"['People in Continuing Care for Cocaine Dependence', 'individuals with cocaine dependence from intensive outpatient programs (IOPs', 'Methods:  Data were drawn from two studies examining adults ( N \u2009=\u2009489) with cocaine dependence in IOPs for substance use disorders collected between 2004 and 2009']",['Social Support and 12-Step Involvement'],"['University of Rhode Island change assessment questionnaire, timeline followback, thoughts about abstinence, perceived social support - friend, and family versions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0600427', 'cui_str': 'Cocaine dependence'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}]","[{'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0035487', 'cui_str': 'Rhode Island'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",,0.0235709,Greater perceived friend social support was associated with greater readiness to change whereas greater perceived familial social support was associated with substance use goal; greater social support from both friends and family were associated with less substance use.,"[{'ForeName': 'Samantha J', 'Initials': 'SJ', 'LastName': 'Lookatch', 'Affiliation': 'Veterans Integrated Service Network 4, Mental Illness Research, Education and Clinical Center Michael J. Crescenz VA Medical Center , Philadelphia , PA , USA.'}, {'ForeName': 'Alexandra S', 'Initials': 'AS', 'LastName': 'Wimberly', 'Affiliation': 'UM School of Social Work, University of Maryland, Baltimore , Baltimore , MA , USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'McKay', 'Affiliation': 'Veterans Integrated Service Network 4, Mental Illness Research, Education and Clinical Center Michael J. Crescenz VA Medical Center , Philadelphia , PA , USA.'}]",Substance use & misuse,['10.1080/10826084.2019.1638406']
1633,32415981,Association of Hyponatremia and Renal Function in Type 1 Cardiorenal syndrome.,"BACKGROUND


Hyponatremia predicts type 1 cardiorenal syndrome in acute decompensated heart failure patients, which associates with poor outcome. Recovery from hyponatremia have been found to associate with better outcome in acute decompensated heart failure patients, but its prognostic value regarding renal function remains unknow.
METHODS


We performed a secondary analysis of CARRESS-HF trial, all patients included had worsening renal function (≥0.3 mg/dl increase in serum creatinine than the nadir). The serum sodium levels of patients were evaluated at baseline, day 4 and day 7 after randomization. Patients were grouped according to the status of hyponatremia: recovery from hyponatremia, no hyponatremia, persistent hyponatremia, and new-onset hyponatremia. Their associations with persistent worsening renal function (serum creatinine ≥0.3 mg/dl higher than the nadir at discharge) were explored.
RESULTS


118 patients suffered from persistent worsening renal function. Baseline hyponatremia was not associated with persistent worsening renal function (odds ratio=0.495, P=0.086). Patients in recovery from hyponatremia group had a lowest risk of persistent worsening renal function among the study population. Further, baseline serum sodium level was not associated with the risk of persistent worsening renal function (odds ratio =1.055, P=0.233), while the increases of serum sodium level at day 4 (odds ratio =0.858, P=0.003) and at day 7 (odds ratio =0.821, P<0.001) significantly predicted a lower risk of persistent worsening renal function.
CONCLUSIONS


Recovery from hyponatremia associates with a lower risk of persistent worsening renal function, suggesting that hyponatremia correction may improve renal outcomes in acute decompensated heart failure patients with type 1 cardiorenal syndrome.",2020,"Baseline hyponatremia was not associated with persistent worsening renal function (odds ratio=0.495, P=0.086).","['acute decompensated heart failure patients', 'Patients were grouped according to the status of hyponatremia: recovery from hyponatremia, no hyponatremia, persistent hyponatremia, and new-onset hyponatremia', 'acute decompensated heart failure patients with type 1 cardiorenal syndrome', 'Type 1 Cardiorenal syndrome', '118 patients suffered from persistent worsening renal function']",[],"['renal outcomes', 'risk of persistent worsening renal function', 'worsening renal function', 'serum sodium level', 'Baseline hyponatremia', 'serum sodium levels', 'baseline serum sodium level']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2242703', 'cui_str': 'Cardiorenal syndrome'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",[],"[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}]",118.0,0.0620905,"Baseline hyponatremia was not associated with persistent worsening renal function (odds ratio=0.495, P=0.086).","[{'ForeName': 'Weihao', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Ruicong', 'Initials': 'R', 'LastName': 'Xue', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Fangfei', 'Initials': 'F', 'LastName': 'Wei', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Zexuan', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Marvin', 'Initials': 'M', 'LastName': 'Owusu-Agyeman', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Yuzhong', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Yugang', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}]",European journal of clinical investigation,['10.1111/eci.13269']
1634,32415923,Effect of calcitriol combined with sevelamer carbonate on serum parathyroid hormone in patients with chronic renal failure.,"This study aimed to observe and analyze the effect of calcitriol combined with sevelamer carbonate on serum parathyroid hormone in patients with chronic renal failure. This study included 180 patients who had been treated for chronic renal failure in our hospital were enrolled as research objects. The patients were randomly divided into two groups: a research group and a control group, each containing 90 cases. The research group was treated with calcitriol combined with sevelamer carbonate, and the control group was treated with calcitriol alone. The therapeutic effects of the two groups were observed and analyzed by SPSS 21. Comparing the levels of blood indexes (Ca, Cr, P, ALP, iPTH, TC, TG, LDL-C, HDL-C) of the two groups showed no significant difference between the two groups, P &lt;0.05. Our results have the effect of different treatment regimens, the improvement effect of various blood indicators in the research group was significantly better than the control group, p&lt;0.05.  We concluded that the combined therapy of calcitriol and sevelamer carbonate in chronic renal failure patients can significantly improve the therapeutic effect, and at the same time actively improve the serum parathyroid hormone level, which is a treatment model that can be popularized and applied.",2020,"Comparing the levels of blood indexes (Ca, Cr, P, ALP, iPTH, TC, TG, LDL-C, HDL-C) of the two groups showed no significant difference between the two groups, P &lt;0.05.","['chronic renal failure patients', '180 patients who had been treated for chronic renal failure in our hospital were enrolled as research objects', 'patients with chronic renal failure']","['calcitriol and sevelamer carbonate', 'calcitriol alone', 'calcitriol combined with sevelamer carbonate', 'calcitriol combined with sevelamer\xa0carbonate']","['serum parathyroid hormone level', 'therapeutic effects', 'levels of blood indexes (Ca, Cr, P, ALP, iPTH, TC, TG, LDL-C, HDL-C', 'serum parathyroid hormone']","[{'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}]","[{'cui': 'C0006674', 'cui_str': 'Calcitriol'}, {'cui': 'C1721288', 'cui_str': 'Sevelamer carbonate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0428408', 'cui_str': 'Serum parathyroid hormone measurement'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0047008', 'cui_str': ""3,4-O-isopropylidene-3,3',4,5'-tetrahydroxystilbene""}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}]",180.0,0.0114577,"Comparing the levels of blood indexes (Ca, Cr, P, ALP, iPTH, TC, TG, LDL-C, HDL-C) of the two groups showed no significant difference between the two groups, P &lt;0.05.","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Nephrology Department, Tangshan Gongren Hospital, Tangshan, 063000, China.'}, {'ForeName': 'Zhinan', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Nephrology Department, Tangshan Gongren Hospital, Tangshan, 063000, China.'}]","Cellular and molecular biology (Noisy-le-Grand, France)",[]
1635,32416026,"Reduced pain with injection of hyaluronic acid with pre-incorporated lidocaine for nasolabial fold correction: A multicenter, double-blind, randomized, active-controlled, split-face designed, clinical study.","BACKGROUND


Injection of hyaluronic acid (HA) filler for nasolabial fold (NLF) correction is a popular aesthetic procedure. In relation to HA filler injections, effective pain control for patient comfort is an important concern.
OBJECTIVES


We compared the pain relief achieved by HA filler with 0.3% lidocaine (HAF-Lidocaine) with that achieved by HA filler without lidocaine (HAF) for NLF correction.
PATIENTS/METHODS


A total of 62 subjects with visible NLFs were enrolled in this double-blind study at two university hospitals and injected with HAF-Lidocaine and HAF, randomly assigned to the each NLFs. Subjects assessed pain using the visual analog scale (VAS). Blinded independent dermatologists assessed the Wrinkle Severity Rating Scale (WSRS) and subjects assessed the Global Aesthetic Improvement Scale (GAIS) for the evaluation of effectiveness. All adverse events during the follow-up period were recorded.
RESULTS


Immediately after treatment, 95.2% of subjects who were treated with HAF-Lidocaine reported reduced pain when compared with those who were treated with HAF and the mean VAS score difference was 38.6 mm. At 15, 30, 45, and 60 minutes after treatment, respectively, 67.7%, 41.9%, 32.3%, and 21.0% of subjects experienced reduced pain. Based on the mean WSRS and GAIS scores and the incidence of local injection site reactions, the clinical effectiveness and safety profile of HAF-Lidocaine were comparable to those of HAF.
CONCLUSION


We conclude that HA filler containing pre-incorporated lidocaine could reduce pain in Korean patients for NLF correction, and the addition of lidocaine does not affect the effectiveness and safety of HA filler.",2020,Blinded independent dermatologists assessed the Wrinkle Severity Rating Scale (WSRS) and subjects assessed the Global Aesthetic Improvement Scale (GAIS) for the evaluation of effectiveness.,"['nasolabial fold correction', 'Korean patients for NLF correction', '62 subjects with visible NLFs were enrolled in this double-blind study at two university hospitals and injected with']","['HAF-Lidocaine and HAF', 'HAF-Lidocaine', 'hyaluronic acid with pre-incorporated lidocaine', 'lidocaine', 'lidocaine (HAF', 'hyaluronic acid (HA) filler for nasolabial fold (NLF) correction', 'lidocaine (HAF-Lidocaine']","['pain relief', 'Wrinkle Severity Rating Scale (WSRS) and subjects assessed the Global Aesthetic Improvement Scale (GAIS', 'reduced pain', 'pain using the visual analog scale (VAS', 'mean VAS score difference', 'effectiveness and safety of HA filler', 'pain', 'mean WSRS and GAIS scores and the incidence of local injection site reactions, the clinical effectiveness and safety profile of HAF-Lidocaine']","[{'cui': 'C0221328', 'cui_str': 'Nasolabial sulcus structure'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C1720154', 'cui_str': 'Inject'}]","[{'cui': 'C0729441', 'cui_str': 'Filler'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0221328', 'cui_str': 'Nasolabial sulcus structure'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0729441', 'cui_str': 'Filler'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]",62.0,0.229665,Blinded independent dermatologists assessed the Wrinkle Severity Rating Scale (WSRS) and subjects assessed the Global Aesthetic Improvement Scale (GAIS) for the evaluation of effectiveness.,"[{'ForeName': 'Sun Young', 'Initials': 'SY', 'LastName': 'Choi', 'Affiliation': 'Department of Dermatology, Seoul Paik Hospital, Inje University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hye Sung', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kwang Ho', 'Initials': 'KH', 'LastName': 'Yoo', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ji Su', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Konkuk University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Beom Joon', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Yang Won', 'Initials': 'YW', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Konkuk University School of Medicine, Seoul, South Korea.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13421']
1636,32416054,Effect of Opicapone Tablets on Levodopa and 3-O-Methyldopa Pharmacokinetics in Healthy Japanese Subjects: Phase 1 Study.,"This study evaluated the effect of a small-tablet formulation of opicapone for use in clinical trials in Japan on the pharmacokinetics of levodopa (l-dopa) and 3-O-methyldopa (3-OMD). In an open-label, 3-period, single-sequence crossover phase 1 study in 80 healthy Japanese males (aged 20-45 years; body mass index, 18.5 to <30.0 kg/m 2  ), 10 mg of l-dopa/carbidopa 100 was administered 3 times daily on day 0 (period 1) and day 12 (period 3), and opicapone tablets (5, 10, 25, or 50 mg; n = 20 each group) were administered once daily for 11 days (period 2). During periods 1 and 3, plasma concentrations of l-dopa and 3-OMD were measured and pharmacokinetic parameters (maximum observed plasma concentration, time at which maximum concentration was observed, area under the plasma concentration-time curve from time 0 to 5 hours [AUC 5h  ] and from time 0 to 24 hours [AUC 24h  ] following each dose, terminal half-life) of plasma l-dopa and 3-OMD were determined along with the geometric mean ratio (period 3/period 1) of AUC 24h  for l-dopa and 3-OMD. Maximum concentration of l-dopa for the first, second, or third doses of l-dopa/carbidopa did not significantly increase with increasing opicapone dose. The AUC of l-dopa increased with increasing opicapone dose but tended toward a peak plateau with opicapone doses of 25 mg and higher. Geometric mean ratios (90% confidence intervals) of AUC 24h  were 5 mg, 1.16 (1.10-1.21); 10 mg, 1.26 (1.23-1.30); 25 mg, 1.51 (1.44-1.57); 50 mg, 1.60 (1.54-1.66). Opicapone tablets were well tolerated. In Japanese healthy subjects, increases in plasma exposure to l-dopa appear to level off with opicapone doses of 25 mg and higher, which may be relevant for optimal dosing among Japanese patients with Parkinson disease.",2020,The AUC of l-dopa increased with increasing opicapone dose but tended toward a peak plateau with opicapone doses of 25 mg and higher.,"['Healthy Japanese Subjects', '80 healthy Japanese males (aged 20-45 years; body mass index, 18.5 to <30.0\xa0kg/m 2  ), 10\xa0mg of l-dopa', 'Japanese healthy subjects', 'Japanese patients with Parkinson disease']","['Opicapone Tablets', 'Opicapone tablets', 'carbidopa', 'opicapone tablets', 'opicapone', 'levodopa (l-dopa) and 3-O-methyldopa (3-OMD']","['Maximum concentration of l-dopa', 'tolerated', 'plasma l-dopa and 3-OMD', 'Geometric mean ratios', 'plasma concentrations of l-dopa and 3-OMD', 'Levodopa and 3-O-Methyldopa Pharmacokinetics', 'AUC of l-dopa']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517611', 'cui_str': '18.5'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C2933912', 'cui_str': 'opicapone'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0047557', 'cui_str': '3-O-methyldopa'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0047557', 'cui_str': '3-O-methyldopa'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",80.0,0.0464062,The AUC of l-dopa increased with increasing opicapone dose but tended toward a peak plateau with opicapone doses of 25 mg and higher.,"[{'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nomoto', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine, Matsuyama, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takeda', 'Affiliation': 'National Hospital Organization, Sendai-Nishitaga Hospital, Sendai, Japan.'}, {'ForeName': 'Katsuaki', 'Initials': 'K', 'LastName': 'Iwai', 'Affiliation': 'Department of Clinical Development, Ono Pharmaceutical Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Akihisa', 'Initials': 'A', 'LastName': 'Nishimura', 'Affiliation': 'Department of Clinical Development, Ono Pharmaceutical Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Department of Neurology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.799']
1637,27404012,The Effects of Providing Fixed Compensation and Lottery-Based Rewards on Uptake of Medical Male Circumcision in Kenya: A Randomized Trial.,"BACKGROUND


Effective demand creation strategies are needed to increase uptake of medical male circumcision and reduce new HIV infections in eastern and southern Africa. Building on insights from behavioral economics, we assessed whether providing compensation for opportunity costs of time or lottery-based rewards can increase male circumcision uptake in Kenya.
METHODS


Uncircumcised men aged 21-39 years were randomized in 1:1:1 ratio to 2 intervention groups or a control group. One intervention group was offered compensation of US $12.50 conditional on circumcision uptake. Compensation was provided in the form of food vouchers. A second intervention group was offered the opportunity to participate in a lottery with high-value prizes on undergoing circumcision. The primary outcome was circumcision uptake within 3 months.
RESULTS


Among 903 participants enrolled, the group that received compensation of US $12.50 had the highest circumcision uptake (8.4%, 26/308), followed by the lottery-based rewards group (3.3%, 10/302), and the control group (1.3%, 4/299). Logistic regression analysis showed that compared with the control group, the fixed compensation group had significantly higher circumcision uptake [adjusted odds ratio 7.1; 95% CI: 2.4 to 20.8]. The lottery-based rewards group did not have significantly higher circumcision uptake than the control group (adjusted odds ratio 2.5; 95% CI: 0.8 to 8.1).
CONCLUSIONS


Providing compensation was effective in increasing circumcision uptake among men over a short period. The results are consistent with studies showing that such interventions can modify health behaviors by addressing economic barriers and behavioral biases in decision making. Contrary to findings from studies of other health behaviors, lottery-based rewards did not significantly increase circumcision uptake.
TRIAL REGISTRATION


Registry for International Development Impact Evaluations: RIDIE-STUDY-ID-530e60df56107.",2016,"The lottery-based rewards group did not have significantly higher circumcision uptake than the control group (adjusted odds ratio 2.5; 95% CI: 0.8 to 8.1).
","['Kenya', 'eastern and southern Africa', '903 participants enrolled, the group that received compensation of US $12.50 had the highest circumcision uptake (8.4%, 26/308), followed by the lottery-based rewards group (3.3%, 10/302), and the control group (1.3%, 4/299', 'Uncircumcised men aged 21-39 years']",['Providing Fixed Compensation and Lottery-Based Rewards'],"['circumcision uptake', 'circumcision uptake within 3 months']","[{'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0001746', 'cui_str': 'Africa, Southern'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0152058', 'cui_str': 'Compensation (finding)'}, {'cui': 'C0403327', 'cui_str': 'Ritual circumcision (procedure)'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0282021', 'cui_str': 'Uncircumcised'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0152058', 'cui_str': 'Compensation (finding)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}]","[{'cui': 'C0403327', 'cui_str': 'Ritual circumcision (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",903.0,0.0425246,"The lottery-based rewards group did not have significantly higher circumcision uptake than the control group (adjusted odds ratio 2.5; 95% CI: 0.8 to 8.1).
","[{'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Thirumurthy', 'Affiliation': '*Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC; †Carolina Population Center, University of North Carolina at Chapel Hill, Chapel Hill, NC; ‡Impact Research and Development Organization, Kisumu, Kenya; §Final Mile, Mumbai, India; and ‖University of California San Diego, San Diego, CA.'}, {'ForeName': 'Samuel H', 'Initials': 'SH', 'LastName': 'Masters', 'Affiliation': ''}, {'ForeName': 'Samwel', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': ''}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Murray', 'Affiliation': ''}, {'ForeName': 'Ram', 'Initials': 'R', 'LastName': 'Prasad', 'Affiliation': ''}, {'ForeName': 'Joshua G', 'Initials': 'JG', 'LastName': 'Zivin', 'Affiliation': ''}, {'ForeName': 'Eunice', 'Initials': 'E', 'LastName': 'Omanga', 'Affiliation': ''}, {'ForeName': 'Kawango', 'Initials': 'K', 'LastName': 'Agot', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000001045']
1638,21542450,"A randomised controlled trial to evaluate the effects of a self-help workbook intervention on distress, coping and quality of life after breast cancer diagnosis.","OBJECTIVE


To evaluate the efficacy of an interactive self-help workbook in reducing distress, and improving quality of life (QOL) and coping for women recently diagnosed with breast cancer.
DESIGN


Randomised controlled trial comparing the use of the workbook and that of an information booklet.
PARTICIPANTS AND SETTING


49 women with Stage 0 to II breast cancer diagnosed in the previous month and recruited from 1 February 2007 to 1 February 2008, in two urban Australian public hospitals.
MAIN OUTCOME MEASURES


The primary outcome measures were depression, anxiety, and posttraumatic stress. Secondary outcomes included QOL, body image, and the coping styles helplessness/hopelessness, cognitive avoidance and anxious preoccupation.
RESULTS


After controlling for baseline levels, interactions at 3-month follow-up showed that participants in the workbook group had significantly lower levels of posttraumatic stress (F[1,89] = 7.01; P = 0.01), helplessness/hopelessness (F [1,89] = 4.75; P = 0.03), and cognitive avoidance (F [1,89] = 4.95; P = 0.03) than those in the control (information booklet) group. However, women in the workbook group had significantly poorer body image than those in the control group (F [1,89] = 6.43; P = 0.01). At 6 months, only the body image interaction remained significant (F [1,93] = 7.44; P = 0.01).
CONCLUSION


These results suggest that a self-help workbook can be an effective, short-term intervention for improving posttraumatic stress, cognitive avoidance, and certain depressive symptoms in women recently diagnosed with breast cancer. However, issues related to body image need to be dealt with differently.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry",2010,"At 6 months, only the body image interaction remained significant (F [1,93] = 7.44; P = 0.01).
","['49 women with Stage 0 to II breast cancer diagnosed in the previous month and recruited from 1 February 2007 to 1 February 2008, in two urban Australian public hospitals', 'after breast cancer diagnosis', 'women recently diagnosed with breast cancer']","['interactive self-help workbook', 'self-help workbook intervention']","['cognitive avoidance', 'poorer body image', 'quality of life (QOL) and coping', 'helplessness/hopelessness', 'levels of posttraumatic stress', 'distress, coping and quality of life', 'depression, anxiety, and posttraumatic stress', 'QOL, body image, and the coping styles helplessness/hopelessness, cognitive avoidance and anxious preoccupation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441763', 'cui_str': 'Stage 0 (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C2732632', 'cui_str': 'Poor body image'}, {'cui': 'C0034380'}, {'cui': 'C0150063', 'cui_str': 'Feeling powerless (finding)'}, {'cui': 'C0150041', 'cui_str': 'Feeling of hopelessness'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0549165', 'cui_str': 'Preoccupation with ideas'}]",49.0,0.110878,"At 6 months, only the body image interaction remained significant (F [1,93] = 7.44; P = 0.01).
","[{'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Beatty', 'Affiliation': 'School of Psychology, Flinders University, Adelaide, SA. lisa.beatty@flinders.edu.au'}, {'ForeName': 'Bogda', 'Initials': 'B', 'LastName': 'Koczwara', 'Affiliation': ''}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Rice', 'Affiliation': ''}, {'ForeName': 'Tracey D', 'Initials': 'TD', 'LastName': 'Wade', 'Affiliation': ''}]",The Medical journal of Australia,[]
1639,32416055,"Pharmacokinetics and Bioequivalence Evaluation of Erlotinib Hydrochloride Tablets: Randomized, Open-Label, 2-Period Crossover Study in Healthy Chinese Subjects.","A randomized, open-label, 2-period crossover study was performed to evaluate the pharmacokinetic properties and bioequivalence of 2 erlotinib hydrochloride tablets (a test formulation and a reference formulation) in healthy Chinese subjects. Subjects were randomized to receive a single oral dose of the erlotinib hydrochloride test or reference formulation (150 mg) under fasting conditions. The washout period was 12 days. Blood samples were collected at scheduled time points, and plasma concentrations were determined using a high-performance liquid chromatography-tandem mass spectrometry method. A noncompartmental method was used to calculate pharmacokinetic parameters and to evaluate the bioequivalence of the 2 formulations. Safety assessments were performed during the whole study period. The results suggest that the pharmacokinetic parameter values of the test formulation were similar to those of the reference formulation. The 90% confidence intervals of the geometric least-squares mean ratios of the test to reference formulation were 94.06% to 105.43% for maximum concentration, 88.21% to 97.57% for area under the concentration-time curve to last measurement, and 87.37% to 97.14% for area under the curve extrapolated to infinity, which are all within the accepted bioequivalence range of 80% to 125%. No serious adverse events occurred during the study. These findings suggest that the 2 erlotinib hydrochloride tablets were bioequivalent in accordance with predetermined regulatory criteria.",2020,A noncompartmental method was used to calculate pharmacokinetic parameters and to evaluate the bioequivalence of the 2 formulations.,"['Healthy Chinese Subjects', 'healthy Chinese subjects']","['erlotinib hydrochloride test or reference formulation (150 mg) under fasting conditions', 'erlotinib hydrochloride tablets', 'Erlotinib Hydrochloride Tablets']","['serious adverse events', 'pharmacokinetic properties and bioequivalence']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C1533491', 'cui_str': 'Erlotinib hydrochloride'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}]",,0.0161733,A noncompartmental method was used to calculate pharmacokinetic parameters and to evaluate the bioequivalence of the 2 formulations.,"[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Zourong', 'Initials': 'Z', 'LastName': 'Ruan', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Jinliang', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Shao', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Yichao', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Yanlu', 'Initials': 'Y', 'LastName': 'Guan', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.811']
1640,32416201,Effect of exercise-based cardiac rehabilitation on clinical outcomes in patients with myocardial infarction in the absence of obstructive coronary artery disease (MINOCA): A prospective cohort study.,"BACKGROUND


Myocardial infarction in the absence of obstructive coronary artery disease (MINOCA) is characterized by clinical evidence of myocardial infarction with nonobstructive coronary stenosis on angiography (stenosis < 50%). Studies on the effect that exercise-based cardiac rehabilitation (CR) has on outcomes in MINOCA patients are lacking. Therefore, the purpose of this study was to determine the effect of exercise-based CR on clinical outcomes in patients with MINOCA.
METHODS


A total of 524 participants with MINOCA were recruited in this prospective cohort study from August 2014 to October 2016 and followed for three years. We randomly divided 524 patients into an exercise-based cardiac rehabilitation group (CR+) and a control group (CR-). The CR+ group followed a home-based exercise-training program three times a week during the three years of moderate continuous training (MCT; 65%-75% of peak heart rate) on a bicycle or treadmill.
RESULTS


After one year of follow-up, the Short Form 36 (SF-36) survey showed apparent improvement in the mean physical health score in the CR+ group compared with the CR- group (P < 0.01). During the three-year follow-up, all-cause mortality occurred in 60 individuals, and major adverse cardiovascular events (MACE) happened in 136 individuals. Kaplan-Meier curves indicated a significant reduction in all-cause mortality (log-rank P < 0.05) and MACE (log-rank P < 0.01) in the CR+ group. A multivariate Cox regression analysis indicated that exercise-based CR was associated with a significant reduction in all-cause mortality (hazard ratio [HR] = 0.483; 95% confidence interval [CI], 0.279-0.818; P < 0.01) and MACE (HR = 0.574; 95% CI, 0.403-0.827; P < 0.001).
CONCLUSIONS


A long-term exercise-based CR program was associated with superior physical health and a significant reduction in all-cause mortality and MACE in patients with MINOCA.",2020,Kaplan-Meier curves indicated a significant reduction in all-cause mortality (log-rank P < 0.05) and MACE (log-rank P < 0.01) in the CR+ group.,"['524 patients into an', 'patients with myocardial infarction in the absence of obstructive coronary artery disease (MINOCA', '524 participants with MINOCA were recruited in this prospective cohort study from August 2014 to October 2016 and followed for three years', 'patients with MINOCA']","['exercise-based cardiac rehabilitation group (CR+) and a control group (CR', 'bicycle or treadmill', 'exercise-based cardiac rehabilitation (CR', 'exercise-based CR', 'exercise-based cardiac rehabilitation', 'CR']","['cause mortality', 'mean physical health score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",524.0,0.0357636,Kaplan-Meier curves indicated a significant reduction in all-cause mortality (log-rank P < 0.05) and MACE (log-rank P < 0.01) in the CR+ group.,"[{'ForeName': 'Chaojie', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, The First Hospital of Jiaxing, The First Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang 314001, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, The First Hospital of Jiaxing, The First Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang 314001, China.'}, {'ForeName': 'Yujuan', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Cardiology, The First Hospital of Jiaxing, The First Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang 314001, China.'}, {'ForeName': 'Zhuoxuan', 'Initials': 'Z', 'LastName': 'Zou', 'Affiliation': 'Department of Cardiology, The First Hospital of Jiaxing, The First Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang 314001, China.'}, {'ForeName': 'Shijun', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The First Hospital of Jiaxing, The First Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang 314001, China.'}, {'ForeName': 'Changlin', 'Initials': 'C', 'LastName': 'Zhai', 'Affiliation': 'Department of Cardiology, The First Hospital of Jiaxing, The First Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang 314001, China.'}, {'ForeName': 'Huilin', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiology, The First Hospital of Jiaxing, The First Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang 314001, China. Electronic address: huhuilin1979@sohu.com.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.05.019']
1641,32416072,"Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study.","BACKGROUND


Isocitrate dehydrogenase 1 (IDH1) mutations occur in approximately 13% of patients with intrahepatic cholangiocarcinoma, a relatively uncommon cancer with a poor clinical outcome. The aim of this international phase 3 study was to assess the efficacy and safety of ivosidenib (AG-120)-a small-molecule targeted inhibitor of mutated IDH1-in patients with previously treated IDH1-mutant cholangiocarcinoma.
METHODS


This multicentre, randomised, double-blind, placebo-controlled, phase 3 study included patients from 49 hospitals in six countries aged at least 18 years with histologically confirmed, advanced, IDH1-mutant cholangiocarcinoma who had progressed on previous therapy, and had up to two previous treatment regimens for advanced disease, an Eastern Cooperative Oncology Group performance status score of 0 or 1, and a measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1. Patients were randomly assigned (2:1) with a block size of 6 and stratified by number of previous systemic treatment regimens for advanced disease to oral ivosidenib 500 mg or matched placebo once daily in continuous 28-day cycles, by means of an interactive web-based response system. Placebo to ivosidenib crossover was permitted on radiological progression per investigator assessment. The primary endpoint was progression-free survival by independent central review. The intention-to-treat population was used for the primary efficacy analyses. Safety was assessed in all patients who had received at least one dose of ivosidenib or placebo. Enrolment is complete; this study is registered with ClinicalTrials.gov, NCT02989857.
FINDINGS


Between Feb 20, 2017, and Jan 31, 2019, 230 patients were assessed for eligibility, and as of the Jan 31, 2019 data cutoff date, 185 patients were randomly assigned to ivosidenib (n=124) or placebo (n=61). Median follow-up for progression-free survival was 6·9 months (IQR 2·8-10·9). Progression-free survival was significantly improved with ivosidenib compared with placebo (median 2·7 months [95% CI 1·6-4·2] vs 1·4 months [1·4-1·6]; hazard ratio 0·37; 95% CI 0·25-0·54; one-sided p<0·0001). The most common grade 3 or worse adverse event in both treatment groups was ascites (four [7%] of 59 patients receiving placebo and nine [7%] of 121 patients receiving ivosidenib). Serious adverse events were reported in 36 (30%) of 121 patients receiving ivosidenib and 13 (22%) of 59 patients receiving placebo. There were no treatment-related deaths.
INTERPRETATION


Progression-free survival was significantly improved with ivosidenib compared with placebo, and ivosidenib was well tolerated. This study shows the clinical benefit of targeting IDH1 mutations in advanced, IDH1-mutant cholangiocarcinoma.
FUNDING


Agios Pharmaceuticals.",2020,Progression-free survival was significantly improved with ivosidenib compared with placebo (median 2·7 months [95% CI 1·6-4·2] vs 1·4 months [1·4-1·6]; hazard ratio 0·37; 95% CI 0·25-0·54; one-sided p<0·0001).,"['mutated IDH1-in patients with previously treated IDH1-mutant cholangiocarcinoma', 'patients from 49 hospitals in six countries aged at least 18 years with histologically confirmed, advanced, IDH1-mutant cholangiocarcinoma who had progressed on previous therapy, and had up to two previous treatment regimens for advanced disease, an Eastern Cooperative Oncology Group performance status score of 0 or 1, and a measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1', 'Between Feb 20, 2017, and Jan 31, 2019, 230 patients were assessed for eligibility, and as of the Jan 31, 2019 data cutoff date, 185 patients']","['Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy', 'ivosidenib or placebo', 'Placebo', 'oral ivosidenib 500 mg or matched placebo', 'ivosidenib', 'ivosidenib (AG-120)-a small-molecule targeted inhibitor', 'placebo']","['Safety', 'tolerated', 'progression-free survival', 'Median follow-up for progression-free survival', 'adverse event', 'efficacy and safety', 'Progression-free survival', 'Serious adverse events']","[{'cui': 'C0022157', 'cui_str': 'Isocitrate dehydrogenase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C4517617', 'cui_str': '185'}]","[{'cui': 'C4682397', 'cui_str': 'ivosidenib'}, {'cui': 'C0022157', 'cui_str': 'Isocitrate dehydrogenase'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3827169', 'cui_str': 'AG-120'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",230.0,0.76452,Progression-free survival was significantly improved with ivosidenib compared with placebo (median 2·7 months [95% CI 1·6-4·2] vs 1·4 months [1·4-1·6]; hazard ratio 0·37; 95% CI 0·25-0·54; one-sided p<0·0001).,"[{'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Medical College at Cornell University, New York, NY, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Macarulla', 'Affiliation': ""Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Milind M', 'Initials': 'MM', 'LastName': 'Javle', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Robin K', 'Initials': 'RK', 'LastName': 'Kelley', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sam J', 'Initials': 'SJ', 'LastName': 'Lubner', 'Affiliation': 'Department of Medicine, University of Wisconsin Carbone Cancer Center, Madison, WI, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Adeva', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Cleary', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Daniel V', 'Initials': 'DV', 'LastName': 'Catenacci', 'Affiliation': 'Department of Medicine, University of Chicago Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Mitesh J', 'Initials': 'MJ', 'LastName': 'Borad', 'Affiliation': 'Department of Hematology-Oncology, Mayo Clinic Cancer Center, Phoenix, AZ, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'Department of Medical Oncology, UCL Cancer Institute, London, UK.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Harris', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Adrian G', 'Initials': 'AG', 'LastName': 'Murphy', 'Affiliation': 'Department of Oncology-Gastrointestinal Cancer, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Do-Youn', 'Initials': 'DY', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Whisenant', 'Affiliation': 'Medical Oncology and Hematology, Utah Cancer Specialists, Salt Lake City, UT, USA.'}, {'ForeName': 'Maeve A', 'Initials': 'MA', 'LastName': 'Lowery', 'Affiliation': 'Trinity St James Cancer Institute, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Lipika', 'Initials': 'L', 'LastName': 'Goyal', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Rachna T', 'Initials': 'RT', 'LastName': 'Shroff', 'Affiliation': 'Department of Medicine, University of Arizona Cancer Center, Tucson, AZ, USA.'}, {'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'El-Khoueiry', 'Affiliation': 'Department of Medicine, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Fan', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Christina X', 'Initials': 'CX', 'LastName': 'Chamberlain', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Liewen', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Camelia', 'Initials': 'C', 'LastName': 'Gliser', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Shuchi S', 'Initials': 'SS', 'LastName': 'Pandya', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'Division of Cancer Sciences, University of Manchester, Manchester, UK; Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Andrew X', 'Initials': 'AX', 'LastName': 'Zhu', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA; Jiahui International Cancer Center, Jiahui Health, Shanghai, China. Electronic address: azhu@mgh.harvard.edu.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30157-1']
1642,32416145,Dose-finding study of a 90-day contraceptive vaginal ring releasing estradiol and segesterone acetate.,"OBJECTIVE


To evaluate serum estradiol (E2) concentrations during use of 90-day contraceptive vaginal rings releasing E2 75, 100, or 200 mcg/day and segesterone acetate (SA) 200 mcg/day to identify a dose that avoids hypoestrogenism. Study Design We conducted a multicenter dose-finding study in healthy, reproductive-aged women with regular cycles with sequential enrollment to increasing E2 dose groups. We evaluated serum E2 concentrations twice weekly for the primary outcome of median E2 concentrations throughout initial 30-day use (target ≥40 pg/mL). In an optional 2-cycle extension substudy, we randomized participants to 2- or 4-day ring-free intervals per 30-day cycle to evaluate bleeding and spotting based on daily diary information.
RESULTS


Sixty-five participants enrolled in E2 75 (n=22), 100 (n=21), and 200 (n=22) mcg/day groups; 35 participated in the substudy. Median serum E2 concentrations in 75 and 100 mcg/day groups were <40 pg/mL. In the 200 mcg/day group, median E2 concentrations peaked on days 4-5 of CVR use at 194 pg/mL (range 114-312 pg/mL) and remained >40 pg/mL throughout 30 days; E2 concentrations were 37 pg/mL (range 28-62 pg/mL) on days 88-90 (n=11). Among the E2 200 mcg/day substudy participants, all had withdrawal bleeding following ring removal. The 2-day ring-free interval group reported zero median unscheduled bleeding and two (range 0-16) and three (range 0-19) unscheduled spotting days in extension cycles 1 and 2, respectively. The 4-day ring-free interval group reported zero median unscheduled bleeding or spotting days.
CONCLUSIONS


Estradiol concentrations with rings releasing E2 200 mcg/day and SA 200 mcg/day avoid hypoestrogenism over 30-day use. Implications A 90-day contraceptive vaginal ring releasing estradiol 200 mcg/day and segesterone acetate 200 mcg/day achieves estradiol concentrations that should avoid hypoestrogenism and effectively suppresses ovulation.",2020,Median serum E2 concentrations in 75 and 100 mcg/day groups were <40 pg/mL.,"['Sixty-five participants enrolled in E2 75 (n=22), 100 (n=21), and 200 (n=22) mcg/day groups; 35 participated in the substudy', 'healthy, reproductive-aged women with regular cycles with sequential enrollment to increasing E2 dose groups']","['contraceptive vaginal ring releasing estradiol 200 mcg/day and segesterone acetate', '90-day contraceptive vaginal ring releasing estradiol and segesterone acetate', '2- or 4-day ring-free intervals per 30-day cycle to evaluate bleeding and spotting based on daily diary information', 'segesterone acetate (SA']","['zero median unscheduled bleeding or spotting days', 'withdrawal bleeding', 'median E2 concentrations', 'Median serum E2 concentrations', 'serum estradiol (E2) concentrations', 'zero median unscheduled bleeding']","[{'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439426', 'cui_str': 'ug/day'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439426', 'cui_str': 'ug/day'}, {'cui': 'C4723383', 'cui_str': 'Segesterone acetate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]","[{'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0152010', 'cui_str': 'Withdrawal bleeding'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}]",65.0,0.194795,Median serum E2 concentrations in 75 and 100 mcg/day groups were <40 pg/mL.,"[{'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, United States. Electronic address: mejchen@ucdavis.edu.'}, {'ForeName': 'Mitchell D', 'Initials': 'MD', 'LastName': 'Creinin', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, United States.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Turok', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, UT, Unitted States.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Archer', 'Affiliation': 'Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA, United States.'}, {'ForeName': 'Kurt T', 'Initials': 'KT', 'LastName': 'Barnhart', 'Affiliation': 'Department of Obstetrics and Gynecology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Carolyn L', 'Initials': 'CL', 'LastName': 'Westhoff', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University College of Physicians and Surgeons, New York, NY, United States.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Thomas', 'Affiliation': 'Reproductive Medicine Research, Department of Obstetrics and Gynecology, University of Cincinnati College of Medicine, Cincinnati, OH, United States.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Jensen', 'Affiliation': 'Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Variano', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, United States.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Sitruk-Ware', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, United States.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Shanker', 'Affiliation': 'Health Decisions, Durham, NC, United States.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Long', 'Affiliation': 'Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, United States.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Blithe', 'Affiliation': 'Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, United States.'}]",Contraception,['10.1016/j.contraception.2020.05.004']
1643,32416073,"Camrelizumab versus investigator's choice of chemotherapy as second-line therapy for advanced or metastatic oesophageal squamous cell carcinoma (ESCORT): a multicentre, randomised, open-label, phase 3 study.","BACKGROUND


Patients with advanced or metastatic oesophageal squamous cell carcinoma have poor prognosis and few treatment options after first-line therapy. We aimed to assess efficacy and safety of the anti-PD-1 antibody camrelizumab versus investigator's choice of chemotherapy in previously treated patients.
METHODS


ESCORT is a randomised, open-label, phase 3 study of patients aged 18 to 75 years with a histological or cytological diagnosis of advanced or metastatic oesophageal squamous cell carcinoma done at 43 hospitals in China. Eligible patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and had progressed on, or were intolerant to, first-line standard therapy. Patients were randomly assigned (1:1) to camrelizumab (200 mg every 2 weeks) or chemotherapy with docetaxel (75 mg/m 2  every 3 weeks) or irinotecan (180 mg/m 2  every 2 weeks), all given intravenously. Central randomisation was done using the Randomization and Trial Supply Management system with block size randomly generated as four or six and stratified by disease and ECOG performance status. The primary endpoint was overall survival, assessed in randomised patients who had received at least one dose of treatment. Safety was assessed in all treated patients. The trial is registered with ClinicalTrials.gov, NCT03099382, and is closed to new participants.
FINDINGS


From May 10, 2017, to July 24, 2018, 457 (75%) of 607 screened patients were randomly assigned to treatment, of whom 228 received camrelizumab treatment and 220 received chemotherapy. As of data cutoff on May 6, 2019, with a median follow-up time of 8·3 months (IQR 4·1-12·8) in the camrelizumab group and 6·2 months (3·6-10·1) in the chemotherapy group, median overall survival was 8·3 months (95% CI 6·8-9·7) in the camrelizumab group and 6·2 months (5·7-6·9) in the chemotherapy group (hazard ratio 0·71 [95% CI 0·57-0·87]; two-sided p=0·0010). The most common treatment-related adverse events of grade 3 or worse were anaemia (camrelizumab vs chemotherapy: six [3%] vs 11 [5%]), abnormal hepatic function (four [2%] vs one [<1%]), and diarrhoea (three [1%] vs nine [4%]). Serious treatment-related adverse events occurred in 37 (16%) of 228 patients in the camrelizumab group, and in 32 (15%) of 220 patients in the chemotherapy group. Ten treatment-related deaths occurred, seven (3%) in the camrelizumab group (three deaths from unknown causes, one enterocolitis, one hepatic function abnormal, one pneumonitis, and one myocarditis) and three (1%) in the chemotherapy group (two deaths from unknown causes, and one gastrointestinal haemorrhage).
INTERPRETATION


Second-line camrelizumab significantly improved overall survival in patients with advanced or metastatic oesophageal squamous cell carcinoma compared with chemotherapy, with a manageable safety profile. It might represent a potential option of standard second-line treatment for patients with oesophageal squamous cell carcinoma in China.
FUNDING


Jiangsu Hengrui Medicine.",2020,"Serious treatment-related adverse events occurred in 37 (16%) of 228 patients in the camrelizumab group, and in 32 (15%) of 220 patients in the chemotherapy group.","['Patients with advanced or metastatic oesophageal squamous cell carcinoma', 'Eligible patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and had progressed on, or were intolerant to, first-line standard therapy', 'From May 10, 2017, to July 24, 2018, 457 (75%) of 607 screened patients', 'advanced or metastatic oesophageal squamous cell carcinoma (ESCORT', 'patients with oesophageal squamous cell carcinoma in China', 'patients with advanced or metastatic oesophageal squamous cell carcinoma', 'patients aged 18 to 75 years with a histological or cytological diagnosis of advanced or metastatic oesophageal squamous cell carcinoma done at 43 hospitals in China', 'previously treated patients']","['anti-PD-1 antibody camrelizumab', 'camrelizumab', 'chemotherapy with docetaxel', 'Camrelizumab', 'camrelizumab treatment and 220 received chemotherapy', 'chemotherapy', 'irinotecan']","['Safety', 'overall survival', 'diarrhoea', 'efficacy and safety', 'median overall survival', 'adverse events', 'deaths', 'abnormal hepatic function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0205471', 'cui_str': 'Cytologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C4682408', 'cui_str': 'camrelizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}]",,0.242005,"Serious treatment-related adverse events occurred in 37 (16%) of 228 patients in the camrelizumab group, and in 32 (15%) of 220 patients in the chemotherapy group.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Gastrointestinal Oncology, Cancer Center, Fifth Medical Center General Hospital of PLA, Beijing, China. Electronic address: jmxu2003@yahoo.com.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Shanghai Cancer Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Zhuang', 'Affiliation': 'Department of Thoracic Medical Oncology, Fujian Province Cancer Hospital, Fuzhou, China.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Oncology Department, The Second Affiliated Hospital of Anhui Medical University, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Helong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Oncology Department, Tangdu Hospital of the Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Zuoxing', 'Initials': 'Z', 'LastName': 'Niu', 'Affiliation': 'Internal Medicine Ward 4, Shandong Cancer Hospital, Jinan, China.'}, {'ForeName': 'Qingxia', 'Initials': 'Q', 'LastName': 'Fan', 'Affiliation': 'Medical Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Lizhu', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Oncology Center, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Kangsheng', 'Initials': 'K', 'LastName': 'Gu', 'Affiliation': 'Medical Oncology, The First Affiliated Hospital of Anhui Medical University, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Medical Oncology, Henan Cancer Hospital, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Ba', 'Affiliation': 'Medical Oncology, Tianjin Cancer Hospital, Tianjin, China.'}, {'ForeName': 'Zhanhui', 'Initials': 'Z', 'LastName': 'Miao', 'Affiliation': 'Oncology Department, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': ""Oncology Department, The First People's Hospital of Lianyungang, Lianyungang, China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': ""Oncology Center, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Fu', 'Affiliation': 'Department of Radiotherapy, 900 Hospital of the Joint Logistics Team, Fuzhou, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Gan', 'Affiliation': 'The Oncology Department, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Radiotherapy, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Xianbao', 'Initials': 'X', 'LastName': 'Zhan', 'Affiliation': 'Department of Medical Oncology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Tianshu', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Integrated Chinese and Western Medical Oncology, Jiangxi Cancer Hospital, Nanchang, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Gastrointestinal Oncology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Yongqian', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'Medical Oncology, Jiangsu Province Hospital, Nanjing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Jiangsu Hengrui Medicine, Shanghai, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Jiangsu Hengrui Medicine, Shanghai, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Jiangsu Hengrui Medicine, Shanghai, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30110-8']
1644,32416157,Effects of high and low sucrose-containing beverages on blood glucose and hypoglycemic-like symptoms.,"BACKGROUND AND AIMS


There is this intriguing but not yet well-explored suggestion that highly absorbable sucrose-sweetened drinks might exacerbate hunger by promoting temporal hypoglycemia-like responses already in non-diabetic healthy individuals. This might provide a possible additional explanatory mechanism for previous reported associations between consumption of sugar-sweetened drinks and body weight gain. The current study involves two separate and independently conducted human experiments exploring the effects of two different single-doses of sugar-sweetened beverages on temporal blood glucose nadir and possible related behavioral hypoglycemic-like symptoms in healthy participants.
METHODS


By way of two separately conducted between-subjects experiments, effects of 1) a low (29g) sugar-containing beverage compared to a sweetened zero-energy drink and a milk drink (experiment-1) or 2) a high (80g) sugar-sweetened beverage compared to a zero-energy and a non-sweetened colored water drink (experiment-2) were measured on changes in blood glucose, behavioral hypoglycemia, appetite and mood.
RESULTS


Experiment-1: The 29g sucrose containing beverage caused a high (37%) glycemic increase and a smaller response (15%) to the milk drink, which both peaked 30min after consumption, whereas the sweetened zero-energy drink had very little effect on blood glucose. Regardless of the different magnitude of peak glycemic responses, both the sugar and milk drinks rather equally caused blood glucose concentrations to return to normal and stable baseline values 90min later. There were no (different) effects of the beverages on behavioral hypoglycemic-like symptoms, appetite or mood. Experiment-2: the 80g sucrose containing beverage caused a large (72%) glycemic peak response at +30min after consumption, whereas neither the sweetened zero-energy nor the non-sweetened colored water drink had any meaningful effect on blood glucose. After intake of the 80g sugar beverage, blood glucose concentrations remained elevated (13%) at +120min and returned to lower baseline values in the direction of hypoglycemia levels at +165min. There were no (differential) effects of the beverages on behavioral hypoglycemic symptoms, appetite or mood.
CONCLUSIONS


The current findings indicate that instead of a low (29g) sugar-containing beverage, a high (80g) sugar-containing beverage caused blood glucose concentrations to fall below baseline values almost reaching hypoglycemia levels at the end of measurements. There were no hypoglycemic-like behavioral symptoms including changes in appetite or mood: at least not at end of measurements +165min after consumption. Since this might include that in particular consumption of high-glycemic index drinks could still promote symptoms in the longer run, further research is needed to explore possible hypoglycemic-like effects of high dosages of sugar-sweetened beverages across more extended/delayed time measurements.",2020,There were no hypoglycemic-like behavioral symptoms including changes in appetite or mood: at least not at end of measurements +165min after consumption.,"['healthy participants', 'Experiment-1', 'Experiment-2']","['high and low sucrose-containing beverages', 'low (29g) sugar-containing beverage compared to a sweetened zero-energy drink and a milk drink (experiment-1) or 2) a high (80g) sugar-sweetened beverage compared to a zero-energy and a non-sweetened colored water drink (experiment-2', 'sugar-sweetened beverages']","['blood glucose, behavioral hypoglycemia, appetite and mood', 'behavioral hypoglycemic-like symptoms, appetite or mood', 'blood glucose', 'glycemic peak response', 'blood glucose and hypoglycemic-like symptoms', 'hypoglycemic-like behavioral symptoms including changes in appetite or mood', 'blood glucose concentrations', 'behavioral hypoglycemic symptoms, appetite or mood', 'temporal blood glucose nadir']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C3179078', 'cui_str': 'Energy drink'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0426587', 'cui_str': 'Altered appetite'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}]",,0.0416675,There were no hypoglycemic-like behavioral symptoms including changes in appetite or mood: at least not at end of measurements +165min after consumption.,"[{'ForeName': 'C Rob', 'Initials': 'CR', 'LastName': 'Markus', 'Affiliation': 'University Maastricht; Faculty of Psychology and Neuroscience; Dept of Neuropsychology & Psychopharmacology; Maastricht, The Netherlands.. Electronic address: r.markus@maastrichtuniversity.nl.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Rogers', 'Affiliation': 'Nutrition and Behaviour Unit, School of Psychological Science, University of Bristol, Bristol, UK.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112916']
1645,32416309,Clinical Characteristics and Response to Supervised Exercise Therapy in People with Lower Extremity Peripheral Artery Disease.,"INTRODUCTION


Among people with lower extremity peripheral artery disease (PAD), little is known about variation in response to supervised exercise therapy (SET). Clinical characteristics associated with greater responsiveness to SET have not been identified.
METHODS


Data from participants with PAD in two randomized clinical trials comparing SET vs. non-exercising control were combined. The exercise intervention consisted of three times weekly supervised treadmill exercise. The control groups received lectures on health-related topics.
RESULTS


Of 309 unique participants randomized (mean age 67.9 (standard deviation (SD) =9.3), 132 (42.7%) women, 185 (59.9%) black), 285 (92%) completed six-month follow-up. Compared to control, those randomized to SET improved six-minute walk distance by 35.6 meters (95% confidence interval (CI) = +21.4,+49.8, P<0.001). In the 95 (62.1%) participants who attended at least 70% of SET sessions, change in six-minute walk distance varied from -149.4 to +356.0 meters. Thirty-four (35.8%) had no six-minute walk distance improvement. Among all participants, age, sex, race, body mass index, prior lower extremity revascularization and other clinical characteristics did not affect the degree of improvement in six-minute walk distance after SET, relative to the control group. Participants with six-minute walk distance less than the median of 334 meters at baseline had greater percent improvement in six-minute walk distance compared to those with baseline six-minute walk distance above the median (+20.5% vs. +5.3%, P for interaction= 0.0107).
CONCLUSIONS


Among people with PAD, substantial variability exists in walking improvement after SET. Shorter 6-minute walk distance at baseline was associated with greater improvement after SET, but other clinical characteristics, including age, sex, prior lower extremity revascularization, and disease severity, did not affect responsiveness to exercise therapy.",2020,"Compared to control, those randomized to SET improved six-minute walk distance by 35.6 meters (95% confidence interval (CI) = +21.4,+49.8, P<0.001).","['People with Lower Extremity Peripheral Artery Disease', 'people with lower extremity peripheral artery disease (PAD', 'Of 309 unique participants randomized (mean age 67.9 (standard deviation (SD) =9.3), 132 (42.7%) women, 185 (59.9%) black), 285 (92%) completed six-month follow-up', 'Data from participants with PAD in two randomized clinical trials comparing']","['SET vs. non-exercising control', 'lectures on health-related topics', 'exercise intervention consisted of three times weekly supervised treadmill exercise', 'Supervised Exercise Therapy']","['Shorter 6-minute walk distance', 'six-minute walk distance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}]",,0.194197,"Compared to control, those randomized to SET improved six-minute walk distance by 35.6 meters (95% confidence interval (CI) = +21.4,+49.8, P<0.001).","[{'ForeName': 'Kruti', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'University of Illinois Chicago.'}, {'ForeName': 'Tamar S', 'Initials': 'TS', 'LastName': 'Polonsky', 'Affiliation': 'University of Chicago, Department of Medicine, Department of Surgery.'}, {'ForeName': 'Melina R', 'Initials': 'MR', 'LastName': 'Kibbe', 'Affiliation': 'University of North Carolina.'}, {'ForeName': 'Jack M', 'Initials': 'JM', 'LastName': 'Guralnik', 'Affiliation': 'University of Maryland Department of Epidemiology.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': 'Stanford University Biomedical Science Data.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Ferrucci', 'Affiliation': 'National Institute on Aging Division of Intramural Research.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Criqui', 'Affiliation': 'University of California at San Diego, Department of Family Medicine and Public Health.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sufit', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Department of Neurology.'}, {'ForeName': 'Christiaan', 'Initials': 'C', 'LastName': 'Leeuwenburgh', 'Affiliation': 'University of Florida, Department of Aging and Geriatric Research.'}, {'ForeName': 'Dongxue', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Northwestern University Feinberg School of Medicine Department of Medicine.'}, {'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Department of Preventive Medicine.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McDermott', 'Affiliation': 'Northwestern University Feinberg School of Medicine Department of Medicine; Northwestern University Feinberg School of Medicine, Department of Preventive Medicine. Electronic address: mdm608@northwestern.edu.'}]",Journal of vascular surgery,['10.1016/j.jvs.2020.04.498']
1646,32416251,Time Course and Management of Key Adverse Events During the Randomized Phase 3 SOLAR-1 Study of PI3K Inhibitor Alpelisib Plus Fulvestrant in Patients With HR-Positive Advanced Breast Cancer.,"BACKGROUND


Alpelisib (α-selective PI3K inhibitor) plus fulvestrant is approved in multiple countries for men and post-menopausal women with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer following progression on or after endocrine therapy. A detailed understanding of alpelisib's safety profile should inform adverse event (AE) management and enhance patient care.
PATIENTS AND METHODS


AEs in the phase 3 SOLAR-1 trial were assessed in patients with and without PIK3CA mutations. The impact of protocol-specified AE-management recommendations was evaluated, including an amendment to optimize hyperglycemia and rash management.
RESULTS


Patients were randomized to fulvestrant plus alpelisib (n=284) or placebo (n=287). The most common grade 3/4 AEs with alpelisib were hyperglycemia (grade 3, 32.7%; grade 4, 3.9%), rash (grade 3, 9.9%), and diarrhea (grade 3, 6.7%). Median time to onset of grade ≥3 toxicity was 15 days (hyperglycemia, based on fasting plasma glucose), 13 days (rash), and 139 days (diarrhea). Metformin alone or in combination with other anti-diabetic agents was used by most patients (87.1%) with hyperglycemia. Preventive anti-rash medication resulted in lower incidence (any grade, 26.7% vs 64.1%) and severity of rash (grade 3, 11.6% vs 22.7%) vs no preventative medication. Discontinuations due to grade ≥3 AEs were lower following more-detailed AE management guidelines (7.9% vs 18.1% previously). Patients with PIK3CA mutations had a median alpelisib dose intensity of 248 mg/day. Median progression-free survival (PFS) with alpelisib was 12.5 and 9.6 months for alpelisib dose intensities ≥248 mg/day and <248 mg/day, respectively, compared with 5.8 months with placebo.
CONCLUSIONS


Hyperglycemia and rash occurred early during alpelisib treatment, while diarrhea occurred at a later timepoint. Early identification, prevention, and intervention, including concomitant medications and alpelisib dose modifications, resulted in less severe toxicities. Reductions in treatment discontinuations and improved PFS at higher alpelisib dose intensities support the need for optimal AE management.",2020,"Preventive anti-rash medication resulted in lower incidence (any grade, 26.7% vs 64.1%) and severity of rash (grade 3, 11.6% vs 22.7%) vs no preventative medication.","['Patients With HR-Positive Advanced Breast Cancer', 'AEs in the phase 3 SOLAR-1 trial were assessed in patients with and without PIK3CA mutations', 'multiple countries for men and post-menopausal women with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer following progression on or after endocrine therapy']","['Metformin', 'Alpelisib (α-selective PI3K inhibitor) plus fulvestrant', 'fulvestrant plus alpelisib', 'PI3K Inhibitor Alpelisib Plus Fulvestrant', 'placebo']","['diarrhea', 'median alpelisib dose intensity', 'PFS', 'Hyperglycemia and rash', 'Time Course and Management of Key Adverse Events', 'Median time to onset of grade ≥3 toxicity', 'Median progression-free survival (PFS', 'rash', 'severe toxicities', 'hyperglycemia', 'severity of rash']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1451005', 'cui_str': 'PIK3CA protein, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C4055478', 'cui_str': 'alpelisib'}, {'cui': 'C0044602', 'cui_str': '1-phosphatidylinositol 3-kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4055478', 'cui_str': 'alpelisib'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.111823,"Preventive anti-rash medication resulted in lower incidence (any grade, 26.7% vs 64.1%) and severity of rash (grade 3, 11.6% vs 22.7%) vs no preventative medication.","[{'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA. Electronic address: Hope.Rugo@ucsf.edu.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'André', 'Affiliation': 'Department of Medical Oncology, INSERM U981, Gustave Roussy, Université Paris-Sud, Villejuif, France.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Department of Breast and Endocrine Surgery, Kanagawa Cancer Center Hospital, Yokohama, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Cerda', 'Affiliation': 'Clinica RedSalud Vitacura, Santiago, Chile.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Toledano', 'Affiliation': 'Institut Curie, Paris, France.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Stemmer', 'Affiliation': 'Institute of Oncology, Davidoff Center, Rabin Medical Center, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Jurado', 'Affiliation': 'Hospital Universitario Canarias, S/C Tenerife, Islas Canarias, Spain.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Juric', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Cancer Center, Boston, MA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Mayer', 'Affiliation': 'Department of Medicine, Hematology and Oncology, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Ciruelos', 'Affiliation': 'Medical Oncology Department, Breast Cancer Unit, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Conte', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology, University of Padua and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': ""Department of Medical Oncology, Institut de Cancérologie de l'Ouest, St Herblain, France.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wilke', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Mills', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lteif', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gaudenzi', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'Department of Medicine and Research, German Breast Group, Neu-Isenburg, Germany; Centre for Haematology and Oncology Bethanien, Frankfurt, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.05.001']
1647,32416333,Convergence of Epicardial and Endocardial RF Ablation for the Treatment of Symptomatic Persistent AF (CONVERGE Trial): Rationale and design.,"Atrial fibrillation is the most common sustained arrhythmia affecting over 33 million people worldwide. Approximately 70% of AF patients have non-paroxysmal AF. As AF progresses from paroxysmal to non-paroxysmal forms, the prevalence of comorbidities increases. The efficacy of catheter ablation for persistent and long standing persistent (LSP) AF is <40%, often requiring multiple ablation procedures with greater cost and potentially more complications. There is an unmet need to effectively treat such patients. METHODS: CONVERGE is an investigational device exempt, prospective, multi-center, open label 2:1 randomized controlled pivotal study to evaluate the overall success of the Convergent hybrid procedure compared to endocardial catheter ablation for the treatment of symptomatic persistent AF refractory or intolerant to at least one Class I and /or III anti-arrhythmic drug (AAD). A total of 153 subjects at 27 centers are treated in the study. The CONVERGE study is differentiated from other studies currently being conducted on the persistent AF population, because a) there is no time restriction on the duration of diagnosed AF in the patients being studied and b) the trial allows patients with left atrial sizes up to 6 centimeters. The ongoing trials are limited to either 6 months, 12 months or 3-years of continuous AF making CONVERGE the only ablation trial thus far to include a substantial portion of patients with longstanding persistent AF. The convergent procedure involves combination of minimally invasive pericardioscopic epicardial ablation with endocardial left atrial ablation. The primary endpoint is freedom from AF/AFL/AF absent class I/III AAD, except for a previously failed class I/ III AAD with no increase in dosage following 3-months through 12-months. The primary safety endpoint is the incidence of major adverse events from the procedure through 30-days post procedure. CONCLUSION: CONVERGE AF compares the overall success of the Convergent hybrid procedure to endocardial catheter ablation for the treatment of persistent and longstanding persistent AF. By providing objective comparative data, the study aims to provide guidance on the treatment of such patients.",2020,AF compares the overall success of the Convergent hybrid procedure to endocardial catheter ablation for the treatment of persistent and longstanding persistent AF.,"['symptomatic persistent AF refractory or intolerant to at least one Class I and /or III anti-arrhythmic drug (AAD', '153 subjects at 27 centers are treated in the study', 'patients with longstanding persistent AF', 'patients with left atrial sizes up to 6 centimeters']","['minimally invasive pericardioscopic epicardial ablation with endocardial left atrial ablation', 'catheter ablation', 'Epicardial and Endocardial RF Ablation', 'endocardial catheter ablation']","['freedom from AF/AFL/AF absent class I/III AAD', 'incidence of major adverse events']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0475210', 'cui_str': 'cm'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0442016', 'cui_str': 'Epicardial'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0014124', 'cui_str': 'Endocardial'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}]","[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",153.0,0.021211,AF compares the overall success of the Convergent hybrid procedure to endocardial catheter ablation for the treatment of persistent and longstanding persistent AF.,"[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'DeLurgio', 'Affiliation': ""Emory St. Joseph's Hospital, Atlanta, GA.""}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Ferguson', 'Affiliation': 'North Mississippi Medical Center, Tupelo, MS.'}, {'ForeName': 'Jaswinder', 'Initials': 'J', 'LastName': 'Gill', 'Affiliation': ""Guy's and St. Thomas's Hospital, London, UK.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Blauth', 'Affiliation': ""Guy's and St. Thomas's Hospital, London, UK.""}, {'ForeName': 'Saumil', 'Initials': 'S', 'LastName': 'Oza', 'Affiliation': ""St Vincent's Medical Center, Jacksonville, FL.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mostovych', 'Affiliation': ""St Vincent's Medical Center, Jacksonville, FL.""}, {'ForeName': 'Yashasvi', 'Initials': 'Y', 'LastName': 'Awasthi', 'Affiliation': 'AtriCure, Inc., Mason, OH. Electronic address: yawasthi@atricure.com.'}, {'ForeName': 'Nfii', 'Initials': 'N', 'LastName': 'Ndikintum', 'Affiliation': 'AtriCure, Inc., Mason, OH.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Crossen', 'Affiliation': 'North Mississippi Medical Center, Tupelo, MS.'}]",American heart journal,['10.1016/j.ahj.2020.02.016']
1648,32416385,Transdiagnostic preventative intervention for subclinical anxiety: Development and initial validation.,"Risk factors associated with the development of anxiety disorders have been identified; however, the development of preventive interventions targeting these risk factors is in the nascent stage. To date, preventive interventions have tended to target specific anxiety disorder symptoms (e.g., panic attacks). Although these interventions are effective at reducing risk for the targeted disorder (e.g., panic disorder), the focus of the intervention is narrow, thereby limiting the dissemination of these interventions. One approach that may broaden the scope of our prevention efforts is the development of a transdiagnostic intervention. Currently, transdiagnostic interventions have only been used in those with diagnosed conditions (e.g., anxiety disorders); however, it stands to reason that a transdiagnostic approach may also be helpful for those at-risk for developing anxiety disorders. The present study reported on the development and use of a brief preventative intervention for those with subclinical anxiety (i.e., worry, social anxiety). Participants were randomized into either a transdiagnostic preventative intervention, focused on reduction of safety aids, or a health focused control group. Participants consisted of sixty-nine individuals with subclinical levels of anxiety. Results revealed significant between group differences in the reduction of social anxiety, worry, and levels of impairment with the active intervention group relative to the control group. Further, change in safety aid utilization was a significant mediator in the association between intervention group and social anxiety and worry at Week 1; however, it was not a significant mediator at Month 1. Implications of these results and avenues for future research are discussed.",2020,"Results revealed significant between group differences in the reduction of social anxiety, worry, and levels of impairment with the active intervention group relative to the control group.",['Participants consisted of sixty-nine individuals with subclinical levels of anxiety'],"['transdiagnostic preventative intervention, focused on reduction of safety aids, or a health focused control group', 'Transdiagnostic preventative intervention']","['safety aid utilization', 'social anxiety, worry, and levels of impairment', 'social anxiety and worry']","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",69.0,0.0158088,"Results revealed significant between group differences in the reduction of social anxiety, worry, and levels of impairment with the active intervention group relative to the control group.","[{'ForeName': 'Kristina J', 'Initials': 'KJ', 'LastName': 'Korte', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA; Harvard T.H. Chan School of Public Health, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: kkorte@mgh.harvard.edu.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Florida State University, Tallahassee, FL, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.04.001']
1649,27162478,Prospective validation of a novel dosing scheme for intravenous busulfan in adult patients undergoing hematopoietic stem cell transplantation.,"The objective of this study was to externally validate a new dosing scheme for busulfan. Thirty-seven adult patients who received busulfan as conditioning therapy for hematopoietic stem cell transplantation (HCT) participated in this prospective study. Patients were randomized to receive intravenous busulfan, either as the conventional dosage (3.2 mg/kg daily) or according to the new dosing scheme based on their actual body weight (ABW) (23×ABW(0.5) mg daily) targeting an area under the concentration-time curve (AUC) of 5924 µM·min. Pharmacokinetic profiles were collected using a limited sampling strategy by randomly selecting 2 time points at 3.5, 5, 6, 7 or 22 hours after starting busulfan administration. Using an established population pharmacokinetic model with NONMEM software, busulfan concentrations at the available blood sampling times were predicted from dosage history and demographic data. The predicted and measured concentrations were compared by a visual predictive check (VPC). Maximum a posteriori Bayesian estimators were estimated to calculate the predicted AUC (AUCPRED). The accuracy and precision of the AUCPRED values were assessed by calculating the mean prediction error (MPE) and root mean squared prediction error (RMSE), and compared with the target AUC of 5924 µM·min. VPC showed that most data fell within the 95% prediction interval. MPE and RMSE of AUCPRED were -5.8% and 20.6%, respectively, in the conventional dosing group and -2.1% and 14.0%, respectively, in the new dosing scheme group. These fi ndings demonstrated the validity of a new dosing scheme for daily intravenous busulfan used as conditioning therapy for HCT.",2016,"MPE and RMSE of AUCPRED were -5.8% and 20.6%, respectively, in the conventional dosing group and -2.1% and 14.0%, respectively, in the new dosing scheme group.","['Thirty-seven adult patients who received', 'adult patients undergoing hematopoietic stem cell transplantation']","['intravenous busulfan', 'busulfan as conditioning therapy for hematopoietic stem cell transplantation (HCT']","['visual predictive check (VPC', 'MPE and RMSE of AUCPRED', 'mean prediction error (MPE) and root mean squared prediction error (RMSE', 'accuracy and precision of the AUCPRED values']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",37.0,0.0311502,"MPE and RMSE of AUCPRED were -5.8% and 20.6%, respectively, in the conventional dosing group and -2.1% and 14.0%, respectively, in the new dosing scheme group.","[{'ForeName': 'Sang-Heon', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': 'Department of Clinical Pharmacology, Inha University Hospital, Inha University School of Medicine, Incheon 22332, Korea.'}, {'ForeName': 'Jung-Hee', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea.'}, {'ForeName': 'Hyeong-Seok', 'Initials': 'HS', 'LastName': 'Lim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea.'}, {'ForeName': 'Kyoo-Hyung', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea.'}, {'ForeName': 'Dae-Young', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea.'}, {'ForeName': 'Sangmin', 'Initials': 'S', 'LastName': 'Choe', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Pusan National University Hospital, Busan 49241, Korea.'}, {'ForeName': 'Kyun-Seop', 'Initials': 'KS', 'LastName': 'Bae', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea.'}, {'ForeName': 'Je-Hwan', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea.'}]",The Korean journal of physiology & pharmacology : official journal of the Korean Physiological Society and the Korean Society of Pharmacology,['10.4196/kjpp.2016.20.3.245']
1650,32416376,Accelerating prostate stereotactic ablative body radiotherapy: Efficacy and toxicity of a randomized phase II study of 11 versus 29 days overall treatment time (PATRIOT).,"BACKGROUND


Prostate stereotactic ablative radiotherapy (SABR) regimens differ in time, dose, and fractionation. We report an update of a multicentre, Canadian randomized phase II study to investigate the impact of overall treatment time on quality of life (QOL), efficacy, and toxicity.
METHODS


Men with intermediate risk prostate cancer were randomized to 40 Gy in 5 fractions delivered every other day (EOD) versus once per week (QW). Primary outcome was proportion of patients experiencing a minimally clinically important change (MCIC) in acute bowel QOL using EPIC. Secondary outcomes were toxicity, biochemical failure (BF), other QOL domains, and the rate of salvage therapy.
FINDINGS


152 men from 3 centers were randomized; the median follow-up was 62 months. Results are described for EOD versus QW. Acute bowel and urinary QOL was reported previously. Late changes in QOL were not significantly different between the two arms. There were 1 (1.3%) vs 3 (2.7%) late grade 3 + GI toxicities (p = 0.36) and 5 (6.7%) vs 2 (2.7%) late grade 3 GU toxicities (p = 0.44). Two and 5 patients had BF (5-year failure rate 3.0 vs 7.2%, p = 0.22); 0 and 4 patients received salvage therapy (p = 0.04). 5-Year OS and CSS was 95.8% and 98.6% with no difference between arms (p = 0.49, p = 0.15). 3 patients in the QW arm developed metastases.
INTERPRETATION


Although we previously reported that weekly prostate SABR had better bowel and urinary QOL compared to EOD, the updated results show no difference in late toxicity, QOL, BF, or PSA kinetics. Patients should be counseled that QW SABR reduces short-term toxicity compared to QW SABR.",2020,Late changes in QOL were not significantly different between the two arms.,"['152 men from 3 centers', 'Men with intermediate risk prostate cancer']","['Accelerating prostate stereotactic ablative body radiotherapy', 'salvage therapy', 'Prostate stereotactic ablative radiotherapy (SABR']","['late toxicity, QOL, BF, or PSA kinetics', 'Late changes in QOL', 'proportion of patients experiencing a minimally clinically important change (MCIC) in acute bowel QOL using EPIC', 'Acute bowel and urinary QOL', 'bowel and urinary QOL', 'metastases', 'BF (5-year failure rate', 'late grade 3 GU toxicities', 'toxicity, biochemical failure (BF), other QOL domains, and the rate of salvage therapy', '5-Year OS and CSS', 'quality of life (QOL), efficacy, and toxicity', 'late grade 3\xa0+\xa0GI toxicities']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0265338', 'cui_str': 'Coffin-Siris syndrome'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",152.0,0.180251,Late changes in QOL were not significantly different between the two arms.,"[{'ForeName': 'Yasir', 'Initials': 'Y', 'LastName': 'Alayed', 'Affiliation': 'Radiation Oncology Unit, Department of Medicine, College of Medicine and College of Medicine Research Center, King Saud University, Saudi Arabia; Oncology Center, King Saud University Medical City, Saudi Arabia; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Harvey', 'Initials': 'H', 'LastName': 'Quon', 'Affiliation': 'Tom Baker Cancer Centre, Calgary, Canada.'}, {'ForeName': 'Aldrich', 'Initials': 'A', 'LastName': 'Ong', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Cheung', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chu', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Chung', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Vesprini', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Chowdhury', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Dilip', 'Initials': 'D', 'LastName': 'Panjwani', 'Affiliation': 'BC Cancer Agency, Abbotsford, Canada.'}, {'ForeName': 'Geordi', 'Initials': 'G', 'LastName': 'Pang', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Korol', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Ananth', 'Initials': 'A', 'LastName': 'Ravi', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Boyd', 'Initials': 'B', 'LastName': 'McCurdy', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mamedov', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Deabreu', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Loblaw', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada; Institute of Health Policy Management and Evaluation, University of Toronto, Canada. Electronic address: andrew.loblaw@sunnybrook.ca.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.04.039']
1651,32416406,The effect of a running training intervention on ankle power generation in children and adolescents with cerebral palsy: A randomized controlled trial.,"BACKGROUND


Children and adolescents with cerebral palsy who are classified as Gross Motor Function Classification Scale level I or II are usually able to run but lack ankle power generation for push-off. The aim of this study was to analyze the efficacy of a running training program in improving ankle power generation in children and adolescents with cerebral palsy.
METHODS


This randomized controlled trial compared kinematic and spatiotemporal data collected during running from 38 children and adolescents with unilateral or bilateral cerebral palsy before and after a 12-week running program. Normalized speed, stride length, cadence, foot strike pattern, peak ankle power generation, peak hip flexor power generation in swing and propulsion strategy were calculated. Linear mixed models were developed to analyze differences between groups.
FINDINGS


At follow-up the intervention group had increased normalized speed of running (t = -3.68 p < .01) while the control group got slower (t = 3.17 p < .01). In running, children in Gross Motor Function Classification Scale level II in the intervention group increased ankle power (t = 2.49 p = .01) while the control group did not change (t = 0.38 p = .71). In sprinting, children in Gross Motor Function Classification Scale levels I and II in the intervention group maintained ankle power (level I t = 0.32 p = .75; level II t = 1.56 p = .12) while those in the control group decreased ankle power (level I t = 4.69 p < .01; level II t = 2.52 p = .01). Most within-group differences did not result in significant between-group differences at follow-up.
INTERPRETATION


Power generation for running may be responsive to targeted intervention in children with cerebral palsy.",2020,"In sprinting, children in Gross Motor Function Classification Scale levels I and II in the intervention group maintained ankle power (level","['38 children and adolescents with unilateral or bilateral cerebral palsy before and after a 12-week running program', 'children with cerebral palsy', 'Children and adolescents with cerebral palsy', 'children and adolescents with cerebral palsy']","['running training program', 'running training intervention']","['normalized speed of running', 'Normalized speed, stride length, cadence, foot strike pattern, peak ankle power generation, peak hip flexor power generation in swing and propulsion strategy', 'Gross Motor Function Classification Scale level', 'ankle power (level', 'ankle power']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C3838784', 'cui_str': 'Bilateral cerebral palsy'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0038452', 'cui_str': 'Employee Strikes'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",38.0,0.0435438,"In sprinting, children in Gross Motor Function Classification Scale levels I and II in the intervention group maintained ankle power (level","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chappell', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Bentley, Western Australia, Australia; Ability Centre, Coolbinia, Western Australia, Australia. Electronic address: annie.chappell@abilitycentre.com.au.'}, {'ForeName': 'G T', 'Initials': 'GT', 'LastName': 'Allison', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Bentley, Western Australia, Australia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Williams', 'Affiliation': 'School of Health Sciences, University of Melbourne, Victoria, Australia; Epworth HealthCare, Victoria, Australia. Electronic address: gavin.williams@epworth.org.au.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Gibson', 'Affiliation': ""School of Physiotherapy and Exercise Science, Curtin University, Bentley, Western Australia, Australia; Ability Centre, Coolbinia, Western Australia, Australia; Perth Children's Hospital, Perth, Western Australia, Australia. Electronic address: noula.gibson@health.wa.gov.au.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Bentley, Western Australia, Australia.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105024']
1652,32416432,Effects of an exercise intervention for patients with advanced inoperable lung cancer undergoing chemotherapy: A randomized clinical trial.,"OBJECTIVE


Exercise can improve treatment-related side effects, quality of life, and function in patients with various types of cancer; however, more evidence is needed for patients with advanced inoperable lung cancer.
MATERIAL AND METHODS


We randomized 218 patients with advanced inoperable lung cancer to a 12-week supervised, structured exercise training program (aerobic, strength, and relaxation training) twice weekly versus usual care. Primary outcome was change in maximal oxygen uptake (VO 2  peak). Secondary outcomes were muscle strength, functional capacity, forced expiratory volume in 1 s, health-related quality of life, anxiety, and depression.
RESULTS


There was no significant difference between the intervention and control groups in VO 2  peak. There was a significant improvement in muscle strength. There was also a significant difference between the two for social well-being (Functional Assessment of Cancer Therapy-Lung, FACT-L), anxiety, and depression.
CONCLUSION


There was a significant reduction in the level of anxiety and depression and a significant increase in all muscle strength outcomes in the intervention group compared to patients randomized to usual care. There was a significant difference between the groups for social well-being. The primary outcome did not show a significant improvement in VO 2  peak. Based on our results, future patients with advanced inoperable lung cancer should be considered for supervised exercise during the course of their disease.",2020,There was a significant reduction in the level of anxiety and depression and a significant increase in all muscle strength outcomes in the intervention group compared to patients randomized to usual care.,"['patients with various types of cancer', 'patients with advanced inoperable lung cancer', '218 patients with advanced inoperable lung cancer', 'patients with advanced inoperable lung cancer undergoing']","['chemotherapy', 'exercise intervention', 'structured exercise training program (aerobic, strength, and relaxation training) twice weekly versus usual care']","['muscle strength outcomes', 'social well-being (Functional Assessment of Cancer Therapy-Lung, FACT-L), anxiety, and depression', 'VO 2  peak', 'level of anxiety and depression', 'maximal oxygen uptake (VO 2  peak', 'muscle strength', 'muscle strength, functional capacity, forced expiratory volume in 1\u2009s, health-related quality of life, anxiety, and depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C4517647', 'cui_str': '218'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",218.0,0.0758603,There was a significant reduction in the level of anxiety and depression and a significant increase in all muscle strength outcomes in the intervention group compared to patients randomized to usual care.,"[{'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Quist', 'Affiliation': 'University Hospitals Centre for Health Research Department, Rigshospitalet, University of Copenhagen, 9701 Denmark. Electronic address: morten.quist@regionh.dk.'}, {'ForeName': 'Seppo W', 'Initials': 'SW', 'LastName': 'Langer', 'Affiliation': 'Department of Oncology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lillelund', 'Affiliation': 'University Hospitals Centre for Health Research Department, Rigshospitalet, University of Copenhagen, 9701 Denmark.'}, {'ForeName': 'Lærke', 'Initials': 'L', 'LastName': 'Winther', 'Affiliation': 'University Hospitals Centre for Health Research Department, Rigshospitalet, University of Copenhagen, 9701 Denmark.'}, {'ForeName': 'Jørgen H', 'Initials': 'JH', 'LastName': 'Laursen', 'Affiliation': 'Department of Oncology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Karl B', 'Initials': 'KB', 'LastName': 'Christensen', 'Affiliation': 'Section of Biostatistics, University of Copenhagen, Denmark.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Rørth', 'Affiliation': 'Department of Oncology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Lis', 'Initials': 'L', 'LastName': 'Adamsen', 'Affiliation': 'University Hospitals Centre for Health Research Department, Rigshospitalet, University of Copenhagen, 9701 Denmark; Department of Public Health, University of Copenhagen, Denmark.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.05.003']
1653,31557492,Endocrine effects of the novel ghrelin receptor inverse agonist PF-5190457: Results from a placebo-controlled human laboratory alcohol co-administration study in heavy drinkers.,"Both animal and human work suggests that the ghrelin system may be involved in the mechanisms that regulate the development and maintenance of alcohol use disorder. Previously, in a Phase 1b study, we tested pharmacological blockade of the growth hormone secretagogue receptor 1a (GHS-R1a, also known as the ghrelin receptor), in heavy drinking individuals with PF-5190457, an orally bioavailable, potent and selective GHS-R1a inverse agonist. We report here the effects of PF-5190457 on endocrine blood concentrations of amylin, gastric inhibitory polypeptide, glucagon-like peptide 1, insulin, leptin, pancreatic polypeptide, peptide YY, thyroid stimulating hormone, free triiodothyronine (T3), thyroxine (T4), cortisol, prolactin, and glucose during PF-5190457 dosing, as compared to placebo, in absence of alcohol as well as during an alcohol challenge when PF-5190457 was on steady-state. Blood hormone levels were largely unaffected by PF-5190457, both during dosing and in the context of alcohol challenge. The safety-related relevance of these findings to further develop PF-5190547 in alcohol use disorder is discussed. CLINICALTRIALS.GOV: NCT02039349. This article is part of the special issue on 'Neuropeptides'.",2020,"Blood hormone levels were largely unaffected by PF-5190457, both during dosing and in the context of alcohol challenge.",['controlled human laboratory alcohol co-administration study in heavy drinkers'],"['placebo', 'PF-5190457', 'novel ghrelin receptor inverse agonist']","['endocrine blood concentrations of amylin, gastric inhibitory polypeptide, glucagon-like peptide 1, insulin, leptin, pancreatic polypeptide, peptide YY, thyroid stimulating hormone, free triiodothyronine (T3), thyroxine (T4), cortisol, prolactin, and glucose', 'Blood hormone levels']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4279098', 'cui_str': 'PF-5190457'}, {'cui': 'C0391690', 'cui_str': 'GHSR Protein'}, {'cui': 'C0439850', 'cui_str': 'Inverse (qualifier value)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C1313904', 'cui_str': 'Blood concentration, test strip measurement'}, {'cui': 'C0063684', 'cui_str': 'Amylin'}, {'cui': 'C0017132', 'cui_str': 'Glucose-Dependent Insulin-Releasing Peptide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0030298', 'cui_str': 'Pancreatic Polypeptide Hormone'}, {'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0370097', 'cui_str': 'Free triiodothyronine (substance)'}, {'cui': 'C0202231', 'cui_str': 'Thyroxine measurement (procedure)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0005768'}, {'cui': 'C1287355', 'cui_str': 'Finding of hormone level (finding)'}]",,0.018613,"Blood hormone levels were largely unaffected by PF-5190457, both during dosing and in the context of alcohol challenge.","[{'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Lee', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Farokhnia', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA; Center on Compulsive Behaviors, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Enoch', 'Initials': 'E', 'LastName': 'Cobbina', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Anitha', 'Initials': 'A', 'LastName': 'Saravanakumar', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Xiaobai', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Biostatistics and Clinical Epidemiology Service, Clinical Center, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jillian T', 'Initials': 'JT', 'LastName': 'Battista', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Farinelli', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Akhlaghi', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Leggio', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA; Center on Compulsive Behaviors, National Institutes of Health, Bethesda, MD, USA; Medication Development Program, National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Baltimore, MD, USA; Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University, Providence, RI, USA. Electronic address: lorenzo.leggio@nih.gov.'}]",Neuropharmacology,['10.1016/j.neuropharm.2019.107788']
1654,26718567,Shared genetic susceptibility of vascular-related biomarkers with ischemic and recurrent stroke.,"OBJECTIVE


To investigate the genetic contributors to cerebrovascular disease and variation in biomarkers of ischemic stroke.
METHODS


The Vitamin Intervention for Stroke Prevention Trial (VISP) was a randomized, controlled clinical trial of B vitamin supplementation to prevent recurrent stroke, myocardial infarction, or death. VISP collected baseline measures of C-reactive protein (CRP), fibrinogen, creatinine, prothrombin fragments F1+2, thrombin-antithrombin complex, and thrombomodulin prior to treatment initiation. Genome-wide association scans were conducted for these traits and follow-up replication analyses were performed.
RESULTS


We detected an association between CRP single nucleotide polymorphisms (SNPs) and circulating CRP levels (most associated SNP, rs2592902, p = 1.14 × 10(-9)) in 2,100 VISP participants. We discovered a novel association for CRP level in the AKR1D1 locus (rs2589998, p = 7.3 × 10(-8), approaching genome-wide significance) that also is an expression quantitative trait locus for CRP gene expression. We replicated previously identified associations of fibrinogen with SNPs in the FGB and LEPR loci. CRP-associated SNPs and CRP levels were significantly associated with risk of ischemic stroke and recurrent stroke in VISP as well as specific stroke subtypes in METASTROKE. Fibrinogen levels but not fibrinogen-associated SNPs were also found to be associated with recurrent stroke in VISP.
CONCLUSIONS


Our data identify a genetic contribution to inflammatory and hemostatic biomarkers in a stroke population. Additionally, our results suggest shared genetic contributions to circulating CRP levels measured poststroke and risk for incident and recurrent ischemic stroke. These data broaden our understanding of genetic contributors to biomarker variation and ischemic stroke risk, which should be useful in clinical risk evaluation.",2016,CRP-associated SNPs and CRP levels were significantly associated with risk of ischemic stroke and recurrent stroke in VISP as well as specific stroke subtypes in METASTROKE.,"['2,100 VISP participants']","['Vitamin Intervention', 'B vitamin supplementation']","['CRP-associated SNPs and CRP levels', 'recurrent stroke, myocardial infarction, or death', 'Fibrinogen levels', 'CRP single nucleotide polymorphisms (SNPs) and circulating CRP levels', 'C-reactive protein (CRP), fibrinogen, creatinine, prothrombin fragments F1+2, thrombin-antithrombin complex, and thrombomodulin prior to treatment initiation']",[],"[{'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C3714647', 'cui_str': 'B Vitamins'}]","[{'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0337428', 'cui_str': 'Fibrinogen measurement'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0033706', 'cui_str': 'coagulation factor II'}, {'cui': 'C0052128', 'cui_str': 'AT III-protease complex'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}]",2100.0,0.0429563,CRP-associated SNPs and CRP levels were significantly associated with risk of ischemic stroke and recurrent stroke in VISP as well as specific stroke subtypes in METASTROKE.,"[{'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Williams', 'Affiliation': 'From the Center for Public Health Genomics (S.R.W., K.L.K., W.-M.C., S.S.R., M.M.S.), Cardiovascular Research Center (S.R.W.), and Departments of Public Health Sciences (A.M.S., B.B.W.), Neurology (P.M., B.B.W.), Medicine (M.M.S.), Biochemistry and Molecular Genetics (M.M.S.), and Public Health Sciences (S.S.R.), University of Virginia, Charlottesville; Department of Biostatistical Sciences (F.-C.H.), Wake Forest School of Medicine, Winston-Salem, NC; National Human Genome Research Institute (E.B.M.), Bethesda, MD; Departments of Neurology (A.M.S., K.L.F.) and Neuroscience (K.L.F.), Brown University, Providence, RI; Department of Neurology (B.C.), University of Arizona, Tucson; Department of Biology (K.L.K.) and Center for Health Disparities (K.L.K.), East Carolina University, Greenville, NC; Department of Biostatistics (S.N., S.M.G.), University of Washington, Seattle; Department of Clinical Laboratory Sciences (G.D.), University of Cape Town, South Africa; Department of Biochemistry (J.L.R.), University of Missouri, Columbia; Institute for Stroke and Dementia Research (R.M.), Klinikum der Universität München, Ludwig-Maximilians-Universität München, Munich, Germany; Department of Biostatistics (J.D.), Boston University School of Public Health; and Departments of Neurology (S.S.) and Medicine (H.L.), Boston University School of Medicine, MA.'}, {'ForeName': 'Fang-Chi', 'Initials': 'FC', 'LastName': 'Hsu', 'Affiliation': 'From the Center for Public Health Genomics (S.R.W., K.L.K., W.-M.C., S.S.R., M.M.S.), Cardiovascular Research Center (S.R.W.), and Departments of Public Health Sciences (A.M.S., B.B.W.), Neurology (P.M., B.B.W.), Medicine (M.M.S.), Biochemistry and Molecular Genetics (M.M.S.), and Public Health Sciences (S.S.R.), University of Virginia, Charlottesville; Department of Biostatistical Sciences (F.-C.H.), Wake Forest School of Medicine, Winston-Salem, NC; National Human Genome Research Institute (E.B.M.), Bethesda, MD; Departments of Neurology (A.M.S., K.L.F.) and Neuroscience (K.L.F.), Brown University, Providence, RI; Department of Neurology (B.C.), University of Arizona, Tucson; Department of Biology (K.L.K.) and Center for Health Disparities (K.L.K.), East Carolina University, Greenville, NC; Department of Biostatistics (S.N., S.M.G.), University of Washington, Seattle; Department of Clinical Laboratory Sciences (G.D.), University of Cape Town, South Africa; Department of Biochemistry (J.L.R.), University of Missouri, Columbia; Institute for Stroke and Dementia Research (R.M.), Klinikum der Universität München, Ludwig-Maximilians-Universität München, Munich, Germany; Department of Biostatistics (J.D.), Boston University School of Public Health; and Departments of Neurology (S.S.) and Medicine (H.L.), Boston University School of Medicine, MA.'}, {'ForeName': 'Keith L', 'Initials': 'KL', 'LastName': 'Keene', 'Affiliation': 'From the Center for Public Health Genomics (S.R.W., K.L.K., W.-M.C., S.S.R., M.M.S.), Cardiovascular Research Center (S.R.W.), and Departments of Public Health Sciences (A.M.S., B.B.W.), Neurology (P.M., B.B.W.), Medicine (M.M.S.), Biochemistry and Molecular Genetics (M.M.S.), and Public Health Sciences (S.S.R.), University of Virginia, Charlottesville; Department of Biostatistical Sciences (F.-C.H.), Wake Forest School of Medicine, Winston-Salem, NC; National Human Genome Research Institute (E.B.M.), Bethesda, MD; Departments of Neurology (A.M.S., K.L.F.) and Neuroscience (K.L.F.), Brown University, Providence, RI; Department of Neurology (B.C.), University of Arizona, Tucson; Department of Biology (K.L.K.) and Center for Health Disparities (K.L.K.), East Carolina University, Greenville, NC; Department of Biostatistics (S.N., S.M.G.), University of Washington, Seattle; Department of Clinical Laboratory Sciences (G.D.), University of Cape Town, South Africa; Department of Biochemistry (J.L.R.), University of Missouri, Columbia; Institute for Stroke and Dementia Research (R.M.), Klinikum der Universität München, Ludwig-Maximilians-Universität München, Munich, Germany; Department of Biostatistics (J.D.), Boston University School of Public Health; and Departments of Neurology (S.S.) and Medicine (H.L.), Boston University School of Medicine, MA.'}, {'ForeName': 'Wei-Min', 'Initials': 'WM', 'LastName': 'Chen', 'Affiliation': 'From the Center for Public Health Genomics (S.R.W., K.L.K., W.-M.C., S.S.R., M.M.S.), Cardiovascular Research Center (S.R.W.), and Departments of Public Health Sciences (A.M.S., B.B.W.), Neurology (P.M., B.B.W.), Medicine (M.M.S.), Biochemistry and Molecular Genetics (M.M.S.), and Public Health Sciences (S.S.R.), University of Virginia, Charlottesville; Department of Biostatistical Sciences (F.-C.H.), Wake Forest School of Medicine, Winston-Salem, NC; National Human Genome Research Institute (E.B.M.), Bethesda, MD; Departments of Neurology (A.M.S., K.L.F.) and Neuroscience (K.L.F.), Brown University, Providence, RI; Department of Neurology (B.C.), University of Arizona, Tucson; Department of Biology (K.L.K.) and Center for Health Disparities (K.L.K.), East Carolina University, Greenville, NC; Department of Biostatistics (S.N., S.M.G.), University of Washington, Seattle; Department of Clinical Laboratory Sciences (G.D.), University of Cape Town, South Africa; Department of Biochemistry (J.L.R.), University of Missouri, Columbia; Institute for Stroke and Dementia Research (R.M.), Klinikum der Universität München, Ludwig-Maximilians-Universität München, Munich, Germany; Department of Biostatistics (J.D.), Boston University School of Public Health; and Departments of Neurology (S.S.) and Medicine (H.L.), Boston University School of Medicine, MA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Nelson', 'Affiliation': 'From the Center for Public Health Genomics (S.R.W., K.L.K., W.-M.C., S.S.R., M.M.S.), Cardiovascular Research Center (S.R.W.), and Departments of Public Health Sciences (A.M.S., B.B.W.), Neurology (P.M., B.B.W.), Medicine (M.M.S.), Biochemistry and Molecular Genetics (M.M.S.), and Public Health Sciences (S.S.R.), University of Virginia, Charlottesville; Department of Biostatistical Sciences (F.-C.H.), Wake Forest School of Medicine, Winston-Salem, NC; National Human Genome Research Institute (E.B.M.), Bethesda, MD; Departments of Neurology (A.M.S., K.L.F.) and Neuroscience (K.L.F.), Brown University, Providence, RI; Department of Neurology (B.C.), University of Arizona, Tucson; Department of Biology (K.L.K.) and Center for Health Disparities (K.L.K.), East Carolina University, Greenville, NC; Department of Biostatistics (S.N., S.M.G.), University of Washington, Seattle; Department of Clinical Laboratory Sciences (G.D.), University of Cape Town, South Africa; Department of Biochemistry (J.L.R.), University of Missouri, Columbia; Institute for Stroke and Dementia Research (R.M.), Klinikum der Universität München, Ludwig-Maximilians-Universität München, Munich, Germany; Department of Biostatistics (J.D.), Boston University School of Public Health; and Departments of Neurology (S.S.) and Medicine (H.L.), Boston University School of Medicine, MA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Southerland', 'Affiliation': 'From the Center for Public Health Genomics (S.R.W., K.L.K., W.-M.C., S.S.R., M.M.S.), Cardiovascular Research Center (S.R.W.), and Departments of Public Health Sciences (A.M.S., B.B.W.), Neurology (P.M., B.B.W.), Medicine (M.M.S.), Biochemistry and Molecular Genetics (M.M.S.), and Public Health Sciences (S.S.R.), University of Virginia, Charlottesville; Department of Biostatistical Sciences (F.-C.H.), Wake Forest School of Medicine, Winston-Salem, NC; National Human Genome Research Institute (E.B.M.), Bethesda, MD; Departments of Neurology (A.M.S., K.L.F.) and Neuroscience (K.L.F.), Brown University, Providence, RI; Department of Neurology (B.C.), University of Arizona, Tucson; Department of Biology (K.L.K.) and Center for Health Disparities (K.L.K.), East Carolina University, Greenville, NC; Department of Biostatistics (S.N., S.M.G.), University of Washington, Seattle; Department of Clinical Laboratory Sciences (G.D.), University of Cape Town, South Africa; Department of Biochemistry (J.L.R.), University of Missouri, Columbia; Institute for Stroke and Dementia Research (R.M.), Klinikum der Universität München, Ludwig-Maximilians-Universität München, Munich, Germany; Department of Biostatistics (J.D.), Boston University School of Public Health; and Departments of Neurology (S.S.) and Medicine (H.L.), Boston University School of Medicine, MA.'}, {'ForeName': 'Ebony B', 'Initials': 'EB', 'LastName': 'Madden', 'Affiliation': 'From the Center for Public Health Genomics (S.R.W., K.L.K., W.-M.C., S.S.R., M.M.S.), Cardiovascular Research Center (S.R.W.), and Departments of Public Health Sciences (A.M.S., B.B.W.), Neurology (P.M., B.B.W.), Medicine (M.M.S.), Biochemistry and Molecular Genetics (M.M.S.), and Public Health Sciences (S.S.R.), University of Virginia, Charlottesville; Department of Biostatistical Sciences (F.-C.H.), Wake Forest School of Medicine, Winston-Salem, NC; National Human Genome Research Institute (E.B.M.), Bethesda, MD; Departments of Neurology (A.M.S., K.L.F.) and Neuroscience (K.L.F.), Brown University, Providence, RI; Department of Neurology (B.C.), University of Arizona, Tucson; Department of Biology (K.L.K.) and Center for Health Disparities (K.L.K.), East Carolina University, Greenville, NC; Department of Biostatistics (S.N., S.M.G.), University of Washington, Seattle; Department of Clinical Laboratory Sciences (G.D.), University of Cape Town, South Africa; Department of Biochemistry (J.L.R.), University of Missouri, Columbia; Institute for Stroke and Dementia Research (R.M.), Klinikum der Universität München, Ludwig-Maximilians-Universität München, Munich, Germany; Department of Biostatistics (J.D.), Boston University School of Public Health; and Departments of Neurology (S.S.) and Medicine (H.L.), Boston University School of Medicine, MA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Coull', 'Affiliation': 'From the Center for Public Health Genomics (S.R.W., K.L.K., W.-M.C., S.S.R., M.M.S.), Cardiovascular Research Center (S.R.W.), and Departments of Public Health Sciences (A.M.S., B.B.W.), Neurology (P.M., B.B.W.), Medicine (M.M.S.), Biochemistry and Molecular Genetics (M.M.S.), and Public Health Sciences (S.S.R.), University of Virginia, Charlottesville; Department of Biostatistical Sciences (F.-C.H.), Wake Forest School of Medicine, Winston-Salem, NC; National Human Genome Research Institute (E.B.M.), Bethesda, MD; Departments of Neurology (A.M.S., K.L.F.) and Neuroscience (K.L.F.), Brown University, Providence, RI; Department of Neurology (B.C.), University of Arizona, Tucson; Department of Biology (K.L.K.) and Center for Health Disparities (K.L.K.), East Carolina University, Greenville, NC; Department of Biostatistics (S.N., S.M.G.), University of Washington, Seattle; Department of Clinical Laboratory Sciences (G.D.), University of Cape Town, South Africa; Department of Biochemistry (J.L.R.), University of Missouri, Columbia; Institute for Stroke and Dementia Research (R.M.), Klinikum der Universität München, Ludwig-Maximilians-Universität München, Munich, Germany; Department of Biostatistics (J.D.), Boston University School of Public Health; and Departments of Neurology (S.S.) and Medicine (H.L.), Boston University School of Medicine, MA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Gogarten', 'Affiliation': 'From the Center for Public Health Genomics (S.R.W., K.L.K., W.-M.C., S.S.R., M.M.S.), Cardiovascular Research Center (S.R.W.), and Departments of Public Health Sciences (A.M.S., B.B.W.), Neurology (P.M., B.B.W.), Medicine (M.M.S.), Biochemistry and Molecular Genetics (M.M.S.), and Public Health Sciences (S.S.R.), University of Virginia, Charlottesville; Department of Biostatistical Sciences (F.-C.H.), Wake Forest School of Medicine, Winston-Salem, NC; National Human Genome Research Institute (E.B.M.), Bethesda, MD; Departments of Neurology (A.M.S., K.L.F.) and Neuroscience (K.L.F.), Brown University, Providence, RI; Department of Neurology (B.C.), University of Arizona, Tucson; Department of Biology (K.L.K.) and Center for Health Disparities (K.L.K.), East Carolina University, Greenville, NC; Department of Biostatistics (S.N., S.M.G.), University of Washington, Seattle; Department of Clinical Laboratory Sciences (G.D.), University of Cape Town, South Africa; Department of Biochemistry (J.L.R.), University of Missouri, Columbia; Institute for Stroke and Dementia Research (R.M.), Klinikum der Universität München, Ludwig-Maximilians-Universität München, Munich, Germany; Department of Biostatistics (J.D.), Boston University School of Public Health; and Departments of Neurology (S.S.) and Medicine (H.L.), Boston University School of Medicine, MA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Furie', 'Affiliation': 'From the Center for Public Health Genomics (S.R.W., K.L.K., W.-M.C., S.S.R., M.M.S.), Cardiovascular Research Center (S.R.W.), and Departments of Public Health Sciences (A.M.S., B.B.W.), Neurology (P.M., B.B.W.), Medicine (M.M.S.), Biochemistry and Molecular Genetics (M.M.S.), and Public Health Sciences (S.S.R.), University of Virginia, Charlottesville; Department of Biostatistical Sciences (F.-C.H.), Wake Forest School of Medicine, Winston-Salem, NC; National Human Genome Research Institute (E.B.M.), Bethesda, MD; Departments of Neurology (A.M.S., K.L.F.) and Neuroscience (K.L.F.), Brown University, Providence, RI; Department of Neurology (B.C.), University of Arizona, Tucson; Department of Biology (K.L.K.) and Center for Health Disparities (K.L.K.), East Carolina University, Greenville, NC; Department of Biostatistics (S.N., S.M.G.), University of Washington, Seattle; Department of Clinical Laboratory Sciences (G.D.), University of Cape Town, South Africa; Department of Biochemistry (J.L.R.), University of Missouri, Columbia; Institute for Stroke and Dementia Research (R.M.), Klinikum der Universität München, Ludwig-Maximilians-Universität München, Munich, Germany; Department of Biostatistics (J.D.), Boston University School of Public Health; and Departments of Neurology (S.S.) and Medicine (H.L.), Boston University School of Medicine, MA.'}, {'ForeName': 'Godfrey', 'Initials': 'G', 'LastName': 'Dzhivhuho', 'Affiliation': 'From the Center for Public Health Genomics (S.R.W., K.L.K., W.-M.C., S.S.R., M.M.S.), Cardiovascular Research Center (S.R.W.), and Departments of Public Health Sciences (A.M.S., B.B.W.), Neurology (P.M., B.B.W.), Medicine (M.M.S.), Biochemistry and Molecular Genetics (M.M.S.), and Public Health Sciences (S.S.R.), University of Virginia, Charlottesville; Department of Biostatistical Sciences (F.-C.H.), Wake Forest School of Medicine, Winston-Salem, NC; National Human Genome Research Institute (E.B.M.), Bethesda, MD; Departments of Neurology (A.M.S., K.L.F.) and Neuroscience (K.L.F.), Brown University, Providence, RI; Department of Neurology (B.C.), University of Arizona, Tucson; Department of Biology (K.L.K.) and Center for Health Disparities (K.L.K.), East Carolina University, Greenville, NC; Department of Biostatistics (S.N., S.M.G.), University of Washington, Seattle; Department of Clinical Laboratory Sciences (G.D.), University of Cape Town, South Africa; Department of Biochemistry (J.L.R.), University of Missouri, Columbia; Institute for Stroke and Dementia Research (R.M.), Klinikum der Universität München, Ludwig-Maximilians-Universität München, Munich, Germany; Department of Biostatistics (J.D.), Boston University School of Public Health; and Departments of Neurology (S.S.) and Medicine (H.L.), Boston University School of Medicine, MA.'}, {'ForeName': 'Joe L', 'Initials': 'JL', 'LastName': 'Rowles', 'Affiliation': 'From the Center for Public Health Genomics (S.R.W., K.L.K., W.-M.C., S.S.R., M.M.S.), Cardiovascular Research Center (S.R.W.), and Departments of Public Health Sciences (A.M.S., B.B.W.), Neurology (P.M., B.B.W.), Medicine (M.M.S.), Biochemistry and Molecular Genetics (M.M.S.), and Public Health Sciences (S.S.R.), University of Virginia, Charlottesville; Department of Biostatistical Sciences (F.-C.H.), Wake Forest School of Medicine, Winston-Salem, NC; National Human Genome Research Institute (E.B.M.), Bethesda, MD; Departments of Neurology (A.M.S., K.L.F.) and Neuroscience (K.L.F.), Brown University, Providence, RI; Department of Neurology (B.C.), University of Arizona, Tucson; Department of Biology (K.L.K.) and Center for Health Disparities (K.L.K.), East Carolina University, Greenville, NC; Department of Biostatistics (S.N., S.M.G.), University of Washington, Seattle; Department of Clinical Laboratory Sciences (G.D.), University of Cape Town, South Africa; Department of Biochemistry (J.L.R.), University of Missouri, Columbia; Institute for Stroke and Dementia Research (R.M.), Klinikum der Universität München, Ludwig-Maximilians-Universität München, Munich, Germany; Department of Biostatistics (J.D.), Boston University School of Public Health; and Departments of Neurology (S.S.) and Medicine (H.L.), Boston University School of Medicine, MA.'}, {'ForeName': 'Prachi', 'Initials': 'P', 'LastName': 'Mehndiratta', 'Affiliation': 'From the Center for Public Health Genomics (S.R.W., K.L.K., W.-M.C., S.S.R., M.M.S.), Cardiovascular Research Center (S.R.W.), and Departments of Public Health Sciences (A.M.S., B.B.W.), Neurology (P.M., B.B.W.), Medicine (M.M.S.), Biochemistry and Molecular Genetics (M.M.S.), and Public Health Sciences (S.S.R.), University of Virginia, Charlottesville; Department of Biostatistical Sciences (F.-C.H.), Wake Forest School of Medicine, Winston-Salem, NC; National Human Genome Research Institute (E.B.M.), Bethesda, MD; Departments of Neurology (A.M.S., K.L.F.) and Neuroscience (K.L.F.), Brown University, Providence, RI; Department of Neurology (B.C.), University of Arizona, Tucson; Department of Biology (K.L.K.) and Center for Health Disparities (K.L.K.), East Carolina University, Greenville, NC; Department of Biostatistics (S.N., S.M.G.), University of Washington, Seattle; Department of Clinical Laboratory Sciences (G.D.), University of Cape Town, South Africa; Department of Biochemistry (J.L.R.), University of Missouri, Columbia; Institute for Stroke and Dementia Research (R.M.), Klinikum der Universität München, Ludwig-Maximilians-Universität München, Munich, Germany; Department of Biostatistics (J.D.), Boston University School of Public Health; and Departments of Neurology (S.S.) and Medicine (H.L.), Boston University School of Medicine, MA.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Malik', 'Affiliation': 'From the Center for Public Health Genomics (S.R.W., K.L.K., W.-M.C., S.S.R., M.M.S.), Cardiovascular Research Center (S.R.W.), and Departments of Public Health Sciences (A.M.S., B.B.W.), Neurology (P.M., B.B.W.), Medicine (M.M.S.), Biochemistry and Molecular Genetics (M.M.S.), and Public Health Sciences (S.S.R.), University of Virginia, Charlottesville; Department of Biostatistical Sciences (F.-C.H.), Wake Forest School of Medicine, Winston-Salem, NC; National Human Genome Research Institute (E.B.M.), Bethesda, MD; Departments of Neurology (A.M.S., K.L.F.) and Neuroscience (K.L.F.), Brown University, Providence, RI; Department of Neurology (B.C.), University of Arizona, Tucson; Department of Biology (K.L.K.) and Center for Health Disparities (K.L.K.), East Carolina University, Greenville, NC; Department of Biostatistics (S.N., S.M.G.), University of Washington, Seattle; Department of Clinical Laboratory Sciences (G.D.), University of Cape Town, South Africa; Department of Biochemistry (J.L.R.), University of Missouri, Columbia; Institute for Stroke and Dementia Research (R.M.), Klinikum der Universität München, Ludwig-Maximilians-Universität München, Munich, Germany; Department of Biostatistics (J.D.), Boston University School of Public Health; and Departments of Neurology (S.S.) and Medicine (H.L.), Boston University School of Medicine, MA.'}, {'ForeName': 'Josée', 'Initials': 'J', 'LastName': 'Dupuis', 'Affiliation': 'From the Center for Public Health Genomics (S.R.W., K.L.K., W.-M.C., S.S.R., M.M.S.), Cardiovascular Research Center (S.R.W.), and Departments of Public Health Sciences (A.M.S., B.B.W.), Neurology (P.M., B.B.W.), Medicine (M.M.S.), Biochemistry and Molecular Genetics (M.M.S.), and Public Health Sciences (S.S.R.), University of Virginia, Charlottesville; Department of Biostatistical Sciences (F.-C.H.), Wake Forest School of Medicine, Winston-Salem, NC; National Human Genome Research Institute (E.B.M.), Bethesda, MD; Departments of Neurology (A.M.S., K.L.F.) and Neuroscience (K.L.F.), Brown University, Providence, RI; Department of Neurology (B.C.), University of Arizona, Tucson; Department of Biology (K.L.K.) and Center for Health Disparities (K.L.K.), East Carolina University, Greenville, NC; Department of Biostatistics (S.N., S.M.G.), University of Washington, Seattle; Department of Clinical Laboratory Sciences (G.D.), University of Cape Town, South Africa; Department of Biochemistry (J.L.R.), University of Missouri, Columbia; Institute for Stroke and Dementia Research (R.M.), Klinikum der Universität München, Ludwig-Maximilians-Universität München, Munich, Germany; Department of Biostatistics (J.D.), Boston University School of Public Health; and Departments of Neurology (S.S.) and Medicine (H.L.), Boston University School of Medicine, MA.'}, {'ForeName': 'Honghuang', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'From the Center for Public Health Genomics (S.R.W., K.L.K., W.-M.C., S.S.R., M.M.S.), Cardiovascular Research Center (S.R.W.), and Departments of Public Health Sciences (A.M.S., B.B.W.), Neurology (P.M., B.B.W.), Medicine (M.M.S.), Biochemistry and Molecular Genetics (M.M.S.), and Public Health Sciences (S.S.R.), University of Virginia, Charlottesville; Department of Biostatistical Sciences (F.-C.H.), Wake Forest School of Medicine, Winston-Salem, NC; National Human Genome Research Institute (E.B.M.), Bethesda, MD; Departments of Neurology (A.M.S., K.L.F.) and Neuroscience (K.L.F.), Brown University, Providence, RI; Department of Neurology (B.C.), University of Arizona, Tucson; Department of Biology (K.L.K.) and Center for Health Disparities (K.L.K.), East Carolina University, Greenville, NC; Department of Biostatistics (S.N., S.M.G.), University of Washington, Seattle; Department of Clinical Laboratory Sciences (G.D.), University of Cape Town, South Africa; Department of Biochemistry (J.L.R.), University of Missouri, Columbia; Institute for Stroke and Dementia Research (R.M.), Klinikum der Universität München, Ludwig-Maximilians-Universität München, Munich, Germany; Department of Biostatistics (J.D.), Boston University School of Public Health; and Departments of Neurology (S.S.) and Medicine (H.L.), Boston University School of Medicine, MA.'}, {'ForeName': 'Sudha', 'Initials': 'S', 'LastName': 'Seshadri', 'Affiliation': 'From the Center for Public Health Genomics (S.R.W., K.L.K., W.-M.C., S.S.R., M.M.S.), Cardiovascular Research Center (S.R.W.), and Departments of Public Health Sciences (A.M.S., B.B.W.), Neurology (P.M., B.B.W.), Medicine (M.M.S.), Biochemistry and Molecular Genetics (M.M.S.), and Public Health Sciences (S.S.R.), University of Virginia, Charlottesville; Department of Biostatistical Sciences (F.-C.H.), Wake Forest School of Medicine, Winston-Salem, NC; National Human Genome Research Institute (E.B.M.), Bethesda, MD; Departments of Neurology (A.M.S., K.L.F.) and Neuroscience (K.L.F.), Brown University, Providence, RI; Department of Neurology (B.C.), University of Arizona, Tucson; Department of Biology (K.L.K.) and Center for Health Disparities (K.L.K.), East Carolina University, Greenville, NC; Department of Biostatistics (S.N., S.M.G.), University of Washington, Seattle; Department of Clinical Laboratory Sciences (G.D.), University of Cape Town, South Africa; Department of Biochemistry (J.L.R.), University of Missouri, Columbia; Institute for Stroke and Dementia Research (R.M.), Klinikum der Universität München, Ludwig-Maximilians-Universität München, Munich, Germany; Department of Biostatistics (J.D.), Boston University School of Public Health; and Departments of Neurology (S.S.) and Medicine (H.L.), Boston University School of Medicine, MA.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Rich', 'Affiliation': 'From the Center for Public Health Genomics (S.R.W., K.L.K., W.-M.C., S.S.R., M.M.S.), Cardiovascular Research Center (S.R.W.), and Departments of Public Health Sciences (A.M.S., B.B.W.), Neurology (P.M., B.B.W.), Medicine (M.M.S.), Biochemistry and Molecular Genetics (M.M.S.), and Public Health Sciences (S.S.R.), University of Virginia, Charlottesville; Department of Biostatistical Sciences (F.-C.H.), Wake Forest School of Medicine, Winston-Salem, NC; National Human Genome Research Institute (E.B.M.), Bethesda, MD; Departments of Neurology (A.M.S., K.L.F.) and Neuroscience (K.L.F.), Brown University, Providence, RI; Department of Neurology (B.C.), University of Arizona, Tucson; Department of Biology (K.L.K.) and Center for Health Disparities (K.L.K.), East Carolina University, Greenville, NC; Department of Biostatistics (S.N., S.M.G.), University of Washington, Seattle; Department of Clinical Laboratory Sciences (G.D.), University of Cape Town, South Africa; Department of Biochemistry (J.L.R.), University of Missouri, Columbia; Institute for Stroke and Dementia Research (R.M.), Klinikum der Universität München, Ludwig-Maximilians-Universität München, Munich, Germany; Department of Biostatistics (J.D.), Boston University School of Public Health; and Departments of Neurology (S.S.) and Medicine (H.L.), Boston University School of Medicine, MA.'}, {'ForeName': 'Michèle M', 'Initials': 'MM', 'LastName': 'Sale', 'Affiliation': 'From the Center for Public Health Genomics (S.R.W., K.L.K., W.-M.C., S.S.R., M.M.S.), Cardiovascular Research Center (S.R.W.), and Departments of Public Health Sciences (A.M.S., B.B.W.), Neurology (P.M., B.B.W.), Medicine (M.M.S.), Biochemistry and Molecular Genetics (M.M.S.), and Public Health Sciences (S.S.R.), University of Virginia, Charlottesville; Department of Biostatistical Sciences (F.-C.H.), Wake Forest School of Medicine, Winston-Salem, NC; National Human Genome Research Institute (E.B.M.), Bethesda, MD; Departments of Neurology (A.M.S., K.L.F.) and Neuroscience (K.L.F.), Brown University, Providence, RI; Department of Neurology (B.C.), University of Arizona, Tucson; Department of Biology (K.L.K.) and Center for Health Disparities (K.L.K.), East Carolina University, Greenville, NC; Department of Biostatistics (S.N., S.M.G.), University of Washington, Seattle; Department of Clinical Laboratory Sciences (G.D.), University of Cape Town, South Africa; Department of Biochemistry (J.L.R.), University of Missouri, Columbia; Institute for Stroke and Dementia Research (R.M.), Klinikum der Universität München, Ludwig-Maximilians-Universität München, Munich, Germany; Department of Biostatistics (J.D.), Boston University School of Public Health; and Departments of Neurology (S.S.) and Medicine (H.L.), Boston University School of Medicine, MA.'}, {'ForeName': 'Bradford B', 'Initials': 'BB', 'LastName': 'Worrall', 'Affiliation': 'From the Center for Public Health Genomics (S.R.W., K.L.K., W.-M.C., S.S.R., M.M.S.), Cardiovascular Research Center (S.R.W.), and Departments of Public Health Sciences (A.M.S., B.B.W.), Neurology (P.M., B.B.W.), Medicine (M.M.S.), Biochemistry and Molecular Genetics (M.M.S.), and Public Health Sciences (S.S.R.), University of Virginia, Charlottesville; Department of Biostatistical Sciences (F.-C.H.), Wake Forest School of Medicine, Winston-Salem, NC; National Human Genome Research Institute (E.B.M.), Bethesda, MD; Departments of Neurology (A.M.S., K.L.F.) and Neuroscience (K.L.F.), Brown University, Providence, RI; Department of Neurology (B.C.), University of Arizona, Tucson; Department of Biology (K.L.K.) and Center for Health Disparities (K.L.K.), East Carolina University, Greenville, NC; Department of Biostatistics (S.N., S.M.G.), University of Washington, Seattle; Department of Clinical Laboratory Sciences (G.D.), University of Cape Town, South Africa; Department of Biochemistry (J.L.R.), University of Missouri, Columbia; Institute for Stroke and Dementia Research (R.M.), Klinikum der Universität München, Ludwig-Maximilians-Universität München, Munich, Germany; Department of Biostatistics (J.D.), Boston University School of Public Health; and Departments of Neurology (S.S.) and Medicine (H.L.), Boston University School of Medicine, MA. bbw9r@virginia.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000002319']
1655,31543957,"Protocol for a factorial randomised controlled trial, embedded within WHiTE 8 COPAL, of an Enhanced Trainee Principal Investigator Package and Additional Digital Nudge to increase recruitment rates.","Recruitment remains an issue when conducting randomised controlled trials (RCTs) with a significant proportion of studies failing to reach their target sample size. Studies evaluating interventions to improve recruitment aimed specifically at recruiters to the trial are limited in number. This factorial RCT will evaluate the effectiveness of an educational intervention to trainee principal investigators and a positive reinforcement intervention via an email nudge on increasing recruitment. The targeted recruiters will be in 20 centres nationally recruiting to one large orthopaedic randomised controlled trial, WHiTE 8 COPAL. Centres will be randomised via minimisation to one of four groups. The primary outcome is recruitment rate in the first six months that a centre is actively recruiting, with data being analysed via a Poisson regression model. Results will be presented as adjusted incidence rate ratios with 95% confidence intervals. Secondary outcomes relate to the feasibility and logistics of running the interventions.  We will also collect feedback regarding the educational programme set out for the trainee principal investigators. The study started in August 2018 with the anticipation of the primary objective endpoint by October 2019. The results of this study will be used to inform the design of future RCTs, particularly in orthopaedics in the UK, where the role of Trainee Principal Investigators is now a consistent one across different trials.  Trial registration:  11600053, ISRCTN, 20/08/2018; SWAT 67, Northern Ireland Hub for Trials Methodology Research SWAT repository, 01/10/2017.",2019,"The results of this study will be used to inform the design of future RCTs, particularly in orthopaedics in the UK, where the role of Trainee Principal Investigators is now a consistent one across different trials.  ","['August 2018 with the anticipation of the primary objective endpoint by October 2019', '20 centres nationally recruiting to one large orthopaedic randomised controlled trial, WHiTE 8 COPAL']",[],"['feasibility and logistics of running the interventions', 'recruitment rate in the first six months that a centre is actively recruiting, with data being analysed via a Poisson regression model']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C1564274', 'cui_str': 'Copal'}]",[],"[{'cui': 'C0242415', 'cui_str': 'Logistics'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]",,0.326548,"The results of this study will be used to inform the design of future RCTs, particularly in orthopaedics in the UK, where the role of Trainee Principal Investigators is now a consistent one across different trials.  ","[{'ForeName': 'Nickil', 'Initials': 'N', 'LastName': 'Agni', 'Affiliation': 'Department of Health Sciences, University of York, UK, York, YO10 5DD, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': 'Department of Health Sciences, University of York, UK, York, YO10 5DD, UK.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'McDaid', 'Affiliation': 'Department of Health Sciences, University of York, UK, York, YO10 5DD, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Reed', 'Affiliation': 'Department of Health Sciences, University of York, UK, York, YO10 5DD, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'Department of Health Sciences, University of York, UK, York, YO10 5DD, UK.'}]",F1000Research,['10.12688/f1000research.19743.1']
1656,32416434,The immediate effects of a shoulder brace on muscle activity and scapular kinematics in subjects with shoulder impingement syndrome and rounded shoulder posture: A randomized crossover design.,"BACKGROUND


Round shoulder posture (RSP) is one of the potential risks for shoulder impingement syndrome (SIS) due to alignment deviation of the scapula. Evidence on how the characteristics of a shoulder brace affecting the degree of RSP, shoulder kinematics, and associated muscle activity during movements is limited.
RESEARCH QUESTION


The purposes of this study were (1) to compare the effects of a shoulder brace on clinical RSP measurements, muscle activities and scapular kinematics during arm movements in subjects with shoulder impingement syndrome (SIS) and RSP; and (2) to compare the effects of two configurations (parallel and diagonal) and two tensions (comfortable and forced tension) of the brace straps on muscle activities and scapular kinematics during arm movements in subjects with SIS and RSP.
METHODS


Twenty-four participants (12 males; 12 females) with SIS and RSP were randomly assigned into 2 groups (comfortable then forced, and forced then comfortable) with 2 strap configurations in each tension condition. The pectoralis minor index (PMI), acromial distance (AD) and shoulder angle (SA) were used to assess the degree of RSP. Three-dimensional electromagnetic motion analysis and electromyography were used to record the scapular kinematics and muscle activity during arm movements.
RESULTS


All clinical measurements with the brace were significantly improved (p < 0.05). Under forced tension, muscle activities were higher with the diagonal configuration than with the parallel configuration in the lower trapezius (LT) (1.2-2.3% MVIC, p < 0.05) and serratus anterior (SA) (2.3% MVIC, p = 0.015). For upward rotation and posterior tilting of the scapula, the diagonal configuration was larger than the parallel configuration (1.5°, p = 0.038; 0.4°-0.5°, p < 0.05, respectively).
SIGNIFICANCE


Different characteristics of the straps of the shoulder brace could alter muscle activity and scapular kinematics at different angles during arm movement. Based on the clinical treatment preference, the application of a shoulder brace with a diagonal configuration and forced tension is suggested for SIS and RSP subjects.",2020,All clinical measurements with the brace were significantly improved (p < 0.05).,"['subjects with SIS and RSP.\nMETHODS\n\n\nTwenty-four participants (12 males; 12 females) with SIS and RSP', 'subjects with shoulder impingement syndrome (SIS) and RSP; and (2', 'subjects with shoulder impingement syndrome and rounded shoulder posture']","['Round shoulder posture (RSP', 'shoulder brace', 'two configurations (parallel and diagonal) and two tensions (comfortable and forced tension) of the brace straps']","['pectoralis minor index (PMI), acromial distance (AD) and shoulder angle (SA', 'Under forced tension, muscle activities', 'muscle activity and scapular kinematics', 'clinical RSP measurements, muscle activities and scapular kinematics', 'serratus anterior (SA) ']","[{'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0443198', 'cui_str': 'Diagonal'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0183631', 'cui_str': 'Strap'}]","[{'cui': 'C0224347', 'cui_str': 'Pectoralis minor muscle structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C2717795', 'cui_str': 'Clinical Rounds'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",24.0,0.0621097,All clinical measurements with the brace were significantly improved (p < 0.05).,"[{'ForeName': 'Yuan-Chun', 'Initials': 'YC', 'LastName': 'Chiu', 'Affiliation': 'School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taiwan.'}, {'ForeName': 'Yung-Shen', 'Initials': 'YS', 'LastName': 'Tsai', 'Affiliation': 'Department of Sports Sciences and Institute of Sports Equipment Technology, University of Taipei, Taiwan.'}, {'ForeName': 'Chien-Lung', 'Initials': 'CL', 'LastName': 'Shen', 'Affiliation': 'Department of Products, Taiwan Textile Research Institute, Taiwan.'}, {'ForeName': 'Tyng-Guey', 'Initials': 'TG', 'LastName': 'Wang', 'Affiliation': 'Division of Physical Therapy, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taiwan.'}, {'ForeName': 'Jing-Lan', 'Initials': 'JL', 'LastName': 'Yang', 'Affiliation': 'Division of Physical Therapy, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taiwan. Electronic address: yangjinglan@gmail.com.'}, {'ForeName': 'Jiu-Jenq', 'Initials': 'JJ', 'LastName': 'Lin', 'Affiliation': 'School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taiwan; Division of Physical Therapy, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taiwan. Electronic address: jiujlin@ntu.edu.tw.'}]",Gait & posture,['10.1016/j.gaitpost.2020.04.028']
1657,27061991,"Effects of Aerobic Exercise on the Pulmonary Functions, Respiratory Symptoms and Psychological Status of People Living With HIV.","BACKGROUND


Pulmonary complications, respiratory symptoms and depression are common occurrences which contribute to the morbidity and mortality seen in individuals living with HIV/AIDS. This study investigated the effect of aerobic exercise on the pulmonary functions, respiratory symptoms and psychological status of people living with HIV.
METHODS


This study was conducted in Lagos, Nigeria from October 2014 to May 2015. Forty eligible individuals with HIV aged 18 yr and above participated, of which 33 cooperated to the end. They were recruited from the HIV/AIDS Prevention and Intervention Initiative (APIN) Clinic, Lagos University Teaching Hospital, Nigeria and were randomly assigned to either the study or the control group. The study group received aerobic exercise training three times a week for six weeks and counselling while the control group received only counselling. Pulmonary functions, respiratory symptoms and psychological status were evaluated at baseline and at six weeks. Inferential statistics of paired and independent t-test were used to analyse the data.
RESULTS


Comparison of mean changes in the pulmonary variables of the study group with those of the control group showed significant differences in all but in the respiratory rate (RR) - [Forced Expiratory Volume in one second: P=0.001, Forced Vital Capacity: P=0.001, Peak Expiratory Flow: P=0.001]. There were also significant differences between the mean changes in respiratory symptoms (P=0.001) and depressive symptoms (P=0.001) of study group and those of the control group.
CONCLUSIONS


Aerobic exercise training significantly improved pulmonary functions as well as significantly reduced respiratory and depressive symptoms in people living with HIV.",2016,"[Forced Expiratory Volume in one second: P=0.001, Forced Vital Capacity","['People Living With HIV', 'people living with HIV', 'individuals living with HIV/AIDS', 'Lagos, Nigeria from October 2014 to May 2015', 'They were recruited from the HIV/AIDS Prevention and Intervention Initiative (APIN) Clinic, Lagos University Teaching Hospital, Nigeria', 'Forty eligible individuals with HIV aged 18 yr and above participated, of which 33 cooperated to the end']","['Aerobic Exercise', 'Aerobic exercise training', 'aerobic exercise training', 'aerobic exercise']","['Pulmonary functions, respiratory symptoms and psychological status', 'pulmonary functions, respiratory symptoms and psychological status', 'pulmonary functions', 'respiratory rate (RR) ', 'respiratory symptoms', 'depressive symptoms', 'Forced Vital Capacity', 'Pulmonary Functions, Respiratory Symptoms and Psychological Status', 'respiratory and depressive symptoms']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028075', 'cui_str': 'Federal Republic of Nigeria'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}]",,0.113877,"[Forced Expiratory Volume in one second: P=0.001, Forced Vital Capacity","[{'ForeName': 'Happiness Anulika', 'Initials': 'HA', 'LastName': 'Aweto', 'Affiliation': 'Department of Physiotherapy, College of Medicine, University of Lagos, PMB 12003, Idi-Araba, Lagos, Nigeria. awetohappiness@gmail.com.'}, {'ForeName': 'Ayoola Ibifubara', 'Initials': 'AI', 'LastName': 'Aiyegbusi', 'Affiliation': 'Department of Physiotherapy, College of Medicine, University of Lagos, PMB 12003, Idi-Araba, Lagos, Nigeria.'}, {'ForeName': 'Adaora Justina', 'Initials': 'AJ', 'LastName': 'Ugonabo', 'Affiliation': 'Department of Physiotherapy, College of Medicine, University of Lagos, PMB 12003, Idi-Araba, Lagos, Nigeria.'}, {'ForeName': 'Titilope Adenike', 'Initials': 'TA', 'LastName': 'Adeyemo', 'Affiliation': 'Department of Haematology and Blood transfusion, College of Medicine, University of Lagos, PMB 12003, Idi-Araba, Lagos, Nigeria.'}]",Journal of research in health sciences,[]
1658,32416538,"Peer outreach point-of-care testing as a bridge to hepatitis C care for people who inject drugs in Toronto, Canada.","BACKGROUND


People who inject drugs have high rates of hepatitis C (HCV) and yet many remain undiagnosed and untreated. HCV treatment guidelines and elimination strategies recommend task-shifting to expand where, and by whom, HCV testing and care is delivered.
METHODS


A randomized controlled trial design was used to evaluate if point-of-care (POC) HCV antibody testing by peer outreach workers outside of health and social service spaces would improve engagement in HCV care. People with a lifetime history of injection drug use without prior knowledge of HCV antibody status were randomized to receive HCV outreach plus either POC or referral to community-based HCV program for testing as usual. The study was co-designed by people with lived experience of HCV.
RESULTS


920 people were approached to participate over 14 weeks. After refusals, withdrawals and removal of duplicates, there were 380 study participants. Outreach took place primarily in public spaces (66%) such as parks, coffee shops and apartment lobbies. Participants reported very high rates of poverty, housing instability and recent injection drug use. Despite being at high risk for HCV, 61% had no history or knowledge of past HCV testing (n = 230). Of those who received a POC test 77/195 (39%) were positive for HCV antibodies. There was no change in rates of engagement in HCV care among those who received the POC (n = 6; 3%) compared to those who did not (n = 5; 3%).
CONCLUSION


Peer outreach workers were able to efficiently reach a marginalized group of individuals who had a high HCV antibody prevalence and low rates of prior HCV testing. This improved participants' knowledge of their HCV antibody status, but that knowledge in itself did not lead to any change in participant's subsequent engagement in HCV care. Future work is required to evaluate strategies such as incentives or peer navigators to improve linkage to HCV care after diagnosis.",2020,Peer outreach workers were able to efficiently reach a marginalized group of individuals who had a high HCV antibody prevalence and low rates of prior HCV testing.,"['people with lived experience of HCV', '920 people were approached to participate over 14 weeks', 'by peer outreach workers outside of health and social service spaces', 'People with a lifetime history of injection drug use without prior knowledge of HCV antibody status', 'people who inject drugs in Toronto, Canada']","['HCV outreach plus either POC or referral to community-based HCV program', 'care (POC) HCV antibody testing']",['rates of engagement in HCV care'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0166049', 'cui_str': 'Antibody to hepatitis C virus'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0166049', 'cui_str': 'Antibody to hepatitis C virus'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}]",920.0,0.0380034,Peer outreach workers were able to efficiently reach a marginalized group of individuals who had a high HCV antibody prevalence and low rates of prior HCV testing.,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Broad', 'Affiliation': 'South Riverdale Community Health Centre, 955 Queen St East, Toronto, ON, M4M 3P3, Canada.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Mason', 'Affiliation': 'South Riverdale Community Health Centre, 955 Queen St East, Toronto, ON, M4M 3P3, Canada.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Guyton', 'Affiliation': 'Sherbourne Health, 333 Sherbourne St, Toronto, ON M5A 2S5, Canada.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Lettner', 'Affiliation': 'South Riverdale Community Health Centre, 955 Queen St East, Toronto, ON, M4M 3P3, Canada; Regent Park Community Health Centre, 465 Dundas St East, Toronto, ON M5A 2B2, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Matelski', 'Affiliation': 'University Health Network, 235 - 200 Elizabeth St, Toronto, ON M5G 2C4, Canada.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Powis', 'Affiliation': 'Michael Garron Hospital, 825 Coxwell Ave, Toronto, ON M4C 3E7, Canada. Electronic address: jeff.powis@tehn.ca.'}]",The International journal on drug policy,['10.1016/j.drugpo.2020.102755']
1659,31141427,Temporal Patterns of Knee-Extensor Isokinetic Torque Strength in Male and Female Athletes Following Comparison of Anterior Thigh and Knee Cooling Over a Rewarming Period.,"CONTEXT


The effect of local cooling on muscle strength presents conflicting debates, with literature undecided as to the potential implications for injury, when returning to play following cryotherapy application.
OBJECTIVE


To investigate concentric muscle strength following local cooling over the anterior thigh compared with the knee joint in males and females and the temporal pattern over a 30-minute rewarming period.
DESIGN


Repeated-measures crossover design.
METHOD


Twelve healthy participants randomly assigned to receive cooling intervention on one location, directly over either the anterior thigh or the knee, returning 1 week later to receive the cooling intervention on opposite location. Muscle strength measured via an isokinetic dynamometer at multiple time points (immediately post, 10-, 20-, and 30-min post) coincided with measurement of skin surface temperature (Tsk) using a noninvasive infrared camera.
RESULTS


Significant main effects for time (P ≤ .001, η2 = .126) with preice application higher than all other time points (P ≤ .05) were demonstrated for both peak torque and average torque. There were also significant main effects for isokinetic testing speed, sex of the participant, and position of the ice application for both peak torque and average torque (P ≤ .05). Statistically significant decreases in Tsk were reported in both gender groups across all time points compared with preintervention Tsk for the anterior thigh and knee (P < .05).
CONCLUSIONS


Reductions reported for concentric peak torque and average torque knee-extensor strength in males and females did not fully recover to baseline measures at 30-minute postcryotherapy interventions. Sports medicine practitioners should consider strength deficits of the quadriceps after wetted ice applications, regardless of cooling location (joint/muscle) or gender.",2019,"Statistically significant decreases in Tsk were reported in both gender groups across all time points compared to pre-intervention Tsk for the anterior thigh and knee (p < 0.05).
","['males and females and the temporal pattern over a 30-minute rewarming period', 'Twelve healthy participants randomly assigned to', 'Male and Female Athletes']","['receive one location of cooling intervention, directly over either the anterior thigh or knee, returning 1 week later to receive the opposite cooling location']","['concentric PT and AvT knee extensor strength', 'Knee Extensor Isokinetic Torque Strength', 'Muscle strength measured via an Isokinetic Dynamometer (IKD', 'peak torque (PT) and average torque (AvT', 'muscle strength', 'isokinetic testing speed, sex of the participant and position of the ice application', 'Keywords Isokinetic dynamometry, cryotherapy, knee, quadriceps, strength, thermal imaging']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}, {'cui': 'C0206156', 'cui_str': 'Rewarming'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0349714', 'cui_str': 'Icing (substance)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]",12.0,0.0178748,"Statistically significant decreases in Tsk were reported in both gender groups across all time points compared to pre-intervention Tsk for the anterior thigh and knee (p < 0.05).
","[{'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Alexander', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rhodes', 'Affiliation': ''}]",Journal of sport rehabilitation,['10.1123/jsr.2018-0499']
1660,30843186,Choosing between continuing vitamin K antagonists (VKA) or switching to a direct oral anticoagulant in currently well-controlled patients on VKA for atrial fibrillation: a randomised controlled trial (GAInN).,,2019,,[],['vitamin K antagonists (VKA'],[],[],"[{'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}]",[],,0.0505035,,"[{'ForeName': 'Jasper H A', 'Initials': 'JHA', 'LastName': 'van Miert', 'Affiliation': 'Department of Haematology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Hilde A M', 'Initials': 'HAM', 'LastName': 'Kooistra', 'Affiliation': 'Department of Haematology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Nic J G M', 'Initials': 'NJGM', 'LastName': 'Veeger', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Centre, Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Westerterp', 'Affiliation': 'Certe Thrombosis Service Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Margriet', 'Initials': 'M', 'LastName': 'Piersma-Wichers', 'Affiliation': 'Department of Haematology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Meijer', 'Affiliation': 'Department of Haematology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}]",British journal of haematology,['10.1111/bjh.15856']
1661,31385880,Ultra-Protective Ventilation Reduces Biotrauma in Patients on Venovenous Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome.,"INTRODUCTION


Ventilator settings for patients with severe acute respiratory distress syndrome supported by venovenous extracorporeal membrane oxygenation are currently set arbitrarily. The impact on serum and pulmonary biotrauma markers of the transition to ultra-protective ventilation settings following extracorporeal membrane oxygenation implantation, and different mechanical ventilation strategies while on extracorporeal membrane oxygenation were investigated.
DESIGN


Randomized clinical trial.
SETTINGS


Nine-month monocentric study.
PATIENTS


Severe acute respiratory distress syndrome patients on venovenous extracorporeal membrane oxygenation.
INTERVENTIONS


After starting extracorporeal membrane oxygenation, patients were switched to the bi-level positive airway pressure mode with 1 second of 24 cm H2O high pressure and 2 seconds of 12 cm H2O low pressure for 24 hours. A computer-generated allocation sequence randomized patients to receive each of the following three experimental steps: 1) high pressure 24 cm H2O and low pressure 20 cm H2O (very high positive end-expiratory pressure-very low driving pressure); 2) high pressure 24 cm H2O and low pressure 5 cm H2O (low positive end-expiratory pressure-high driving pressure); and 3) high pressure 17 cm H2O and low pressure 5 cm H2O (low positive end-expiratory pressure-low driving pressure). Plasma and bronchoalveolar lavage soluble receptor for advanced glycation end-products, plasma interleukin-6, and monocyte chemotactic protein-1 were sampled preextracorporeal membrane oxygenation and after 12 hours at each step.
MEASUREMENTS AND MAIN RESULTS


Sixteen patients on ECMO after 7 days (1-11 d) of mechanical ventilation were included. ""Ultra-protective"" mechanical ventilation settings following ECMO initiation were associated with significantly lower plasma sRAGE, interleukin-6, and monocyte chemotactic protein-1 concentrations. Plasma sRAGE and cytokines were comparable within each on-ECMO experimental step, but the lowest bronchoalveolar lavage sRAGE levels were obtained at minimal driving pressure.
CONCLUSIONS


ECMO allows ultra- protective ventilation, which combines significantly lower plateau pressure, tidalvolume, and driving pressure. This ventilation strategy significantly limited pulmonary biotrauma, which couldtherefore decrease ventilator-induced lung injury. However, the optimal ultra-protective ventilation strategy once ECMO is initiated remains undetermined and warrants further investigations. (Crit Care Med 2019; 47:1505-1512).",2019,"""Ultra-protective"" mechanical ventilation settings following ECMO initiation were associated with significantly lower plasma sRAGE, interleukin-6, and monocyte chemotactic protein-1 concentrations.","['Severe acute respiratory distress syndrome patients', 'Sixteen patients on ECMO after 7 days (1-11 d) of mechanical ventilation were included', 'Severe Acute Respiratory Distress Syndrome', 'patients with severe acute respiratory distress syndrome', 'Nine-month monocentric study']","['high pressure 24 cm H2O and low pressure 20 cm H2O (very high positive end-expiratory pressure-very low driving pressure); 2) high pressure 24 cm H2O and low pressure 5 cm H2O (low positive end-expiratory pressure-high driving pressure); and 3) high pressure 17 cm H2O and low pressure 5 cm H2O (low positive end-expiratory pressure-low driving pressure', 'extracorporeal membrane oxygenation implantation', 'Ultra-Protective Ventilation Reduces Biotrauma', 'Venovenous Extracorporeal Membrane Oxygenation', 'venovenous extracorporeal membrane oxygenation']","['plasma sRAGE, interleukin-6, and monocyte chemotactic protein-1 concentrations', 'plateau pressure, tidalvolume, and driving pressure', 'bronchoalveolar lavage sRAGE levels', 'Plasma sRAGE and cytokines']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C3177469', 'cui_str': '(pipzH2)(cdo)H2O'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0442804', 'cui_str': 'Very high (qualifier value)'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0015357', 'cui_str': 'ECLS Treatment'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0391895', 'cui_str': 'Venovenous (qualifier value)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0445176', 'cui_str': 'Plateau pressure (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1535502', 'cui_str': 'Lung Lavage'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}]",,0.111979,"""Ultra-protective"" mechanical ventilation settings following ECMO initiation were associated with significantly lower plasma sRAGE, interleukin-6, and monocyte chemotactic protein-1 concentrations.","[{'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Rozencwajg', 'Affiliation': 'Sorbonne Université, UPMC Univ Paris 06, INSERM UMRS_1166-iCAN, Institute of Cardiometabolism and Nutrition, 75651 Paris Cedex 13, France.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Guihot', 'Affiliation': ""Département d'Immunologie, Assistance Publique-Hôpitaux de Paris, Pitié-Salpêtrière Hospital, 75651 Paris Cedex 13, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Franchineau', 'Affiliation': 'Sorbonne Université, UPMC Univ Paris 06, INSERM UMRS_1166-iCAN, Institute of Cardiometabolism and Nutrition, 75651 Paris Cedex 13, France.'}, {'ForeName': 'Mickael', 'Initials': 'M', 'LastName': 'Lescroat', 'Affiliation': 'Sorbonne Université, UPMC Univ Paris 06, INSERM UMRS_1166-iCAN, Institute of Cardiometabolism and Nutrition, 75651 Paris Cedex 13, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bréchot', 'Affiliation': 'Sorbonne Université, UPMC Univ Paris 06, INSERM UMRS_1166-iCAN, Institute of Cardiometabolism and Nutrition, 75651 Paris Cedex 13, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Hékimian', 'Affiliation': 'Sorbonne Université, UPMC Univ Paris 06, INSERM UMRS_1166-iCAN, Institute of Cardiometabolism and Nutrition, 75651 Paris Cedex 13, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Lebreton', 'Affiliation': 'Sorbonne Université, UPMC Univ Paris 06, INSERM UMRS_1166-iCAN, Institute of Cardiometabolism and Nutrition, 75651 Paris Cedex 13, France.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Autran', 'Affiliation': ""Département d'Immunologie, Assistance Publique-Hôpitaux de Paris, Pitié-Salpêtrière Hospital, 75651 Paris Cedex 13, France.""}, {'ForeName': 'Charles-Edouard', 'Initials': 'CE', 'LastName': 'Luyt', 'Affiliation': 'Sorbonne Université, UPMC Univ Paris 06, INSERM UMRS_1166-iCAN, Institute of Cardiometabolism and Nutrition, 75651 Paris Cedex 13, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Combes', 'Affiliation': 'Sorbonne Université, UPMC Univ Paris 06, INSERM UMRS_1166-iCAN, Institute of Cardiometabolism and Nutrition, 75651 Paris Cedex 13, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Schmidt', 'Affiliation': 'Sorbonne Université, UPMC Univ Paris 06, INSERM UMRS_1166-iCAN, Institute of Cardiometabolism and Nutrition, 75651 Paris Cedex 13, France.'}]",Critical care medicine,['10.1097/CCM.0000000000003894']
1662,31385881,Randomized Clinical Trial of an ICU Recovery Pilot Program for Survivors of Critical Illness.,"OBJECTIVES


To examine the effect of an interdisciplinary ICU recovery program on process measures and clinical outcomes.
DESIGN


A prospective, single-center, randomized pilot trial.
SETTING


Academic, tertiary-care medical center.
PATIENTS


Adult patients admitted to the medical ICU for at least 48 hours with a predicted risk of 30-day same-hospital readmission of at least 15%.
INTERVENTIONS


Patients randomized to the ICU recovery program group were offered a structured 10-intervention program, including an inpatient visit by a nurse practitioner, an informational pamphlet, a 24 hours a day, 7 days a week phone number for the recovery team, and an outpatient ICU recovery clinic visit with a critical care physician, nurse practitioner, pharmacist, psychologist, and case manager. For patients randomized to the usual care group, all aspects of care were determined by treating clinicians.
MEASUREMENTS AND MAIN RESULTS


Among the primary analysis of enrolled patients who survived to hospital discharge, patients randomized to the ICU recovery program (n = 111) and usual care (n = 121) were similar at baseline. Patients in the ICU recovery program group received a median of two interventions compared with one intervention in the usual care group (p < 0.001). A total of 16 patients (14.4%) in the ICU recovery program group and 26 patients (21.5%) in the usual care group were readmitted to the study hospital within 30 days of discharge (p = 0.16). For these patients, the median time to readmission was 21.5 days (interquartile range, 11.5-26.2 d) in the ICU recovery program group and 7 days (interquartile range, 4-21.2 d) in the usual care group (p = 0.03). Four patients (3.6%) in the ICU recovery program and 14 patients (11.6%) in the usual care group were readmitted within 7 days of hospital discharge (p = 0.02). The composite outcome of death or readmission within 30 days of hospital discharge occurred in 20 patients (18%) in the ICU recovery program group and 36 patients (29.8%) in usual care group (p = 0.04).
CONCLUSIONS


This randomized pilot trial found that a multidisciplinary ICU recovery program could deliver more interventions for post ICU recovery than usual care. The finding of longer time-to-readmission with an ICU recovery program should be examined in future trials.",2019,This randomized pilot trial found that a multidisciplinary ICU recovery program could deliver more interventions for post ICU recovery than usual care.,"['Adult patients admitted to the medical ICU for at least 48 hours with a predicted risk of 30-day same-hospital readmission of at least 15', 'Survivors of Critical Illness', 'enrolled patients who survived to hospital discharge, patients randomized to the ICU recovery program (n = 111) and usual care (n = 121', 'Academic, tertiary-care medical center']","['ICU Recovery Pilot Program', 'ICU recovery program group were offered a structured 10-intervention program, including an inpatient visit by a nurse practitioner, an informational pamphlet', 'interdisciplinary ICU recovery program']","['hospital discharge', 'death or readmission within 30 days of hospital discharge', 'median time to readmission']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner (occupation)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0356935,This randomized pilot trial found that a multidisciplinary ICU recovery program could deliver more interventions for post ICU recovery than usual care.,"[{'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Bloom', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Joanna L', 'Initials': 'JL', 'LastName': 'Stollings', 'Affiliation': 'Department of Pharmaceutical Services, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Kirkpatrick', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Byrne', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Sevin', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}]",Critical care medicine,['10.1097/CCM.0000000000003909']
1663,31499384,The clinical role of VeriStrat testing in patients with advanced non-small cell lung cancer considered unfit for first-line platinum-based chemotherapy.,"PURPOSE


We previously demonstrated that the median survival of patients with poor prognosis non-small cell lung cancer (NSCLC) considered unfit for first-line platinum chemotherapy was <4 months. We evaluated whether VeriStrat could be used as a prognostic or predictive biomarker in this population.
EXPERIMENTAL DESIGN


We conducted a randomised double-blind trial among patients with untreated advanced NSCLC considered unfit for platinum chemotherapy because of poor performance status (PS) or multiple comorbidities. All patients received active supportive care (ASC) and were treated with either oral erlotinib or placebo daily. Five hundred twenty-seven patients had plasma samples for VeriStrat classification: good (VeriStrat Good [VSG]) or poor (VeriStrat Poor [VSP]). Main end-point was overall survival.
RESULTS


Fifty-five percent patients had VSG, and 83% had Eastern Cooperative Oncology Group (ECOG) 2-3 at baseline. VeriStrat was strongly associated with survival. Among patients managed with ASC only, the adjusted hazard ratio (HR) was 0.54 (p < 0.001) for VSG versus VSP. The association was consistent across patient factors: HR = 0.25 (p = 0.004) and HR = 0.56 (p < 0.001) for ECOG 0-1 and 2-3, respectively, HR = 0.49 (0070 < 0.001) for age≥75 years and HR = 0.59 (p = 0.007) for stage IV. Several ECOG 2-3 patients had long survival: 2-year survival was 8% for VSG patients who had ASC, compared with 0% for VSP. VeriStrat status did not predict benefit from erlotinib treatment because the HRs for erlotinib versus placebo were similar between VSG and VSP patients.
CONCLUSIONS


VeriStrat was not a predictive marker for survival when considering first-line erlotinib for patients with NSCLC who had poor PS and were not recommended for platinum doublet therapies. However, VeriStrat was an independent prognostic marker of survival. It represents an objective measurement that could be considered alongside other patient factors to provide a more refined assessment of prognosis for this particular patient group. VSG patients could be selected for treatment trials because of better survival, while VSP patients can continue to be treated conservatively or offered trials of less toxic agents.
TRIAL REGISTRATION ISRCTN NUMBER


ISRCTN02370070.",2019,"The association was consistent across patient factors: HR = 0.25 (p = 0.004) and HR = 0.56 (p < 0.001) for ECOG 0-1 and 2-3, respectively, HR = 0.49 (0070 ","['patients with advanced non-small cell lung cancer considered unfit for first-line platinum-based chemotherapy', 'Five hundred twenty-seven patients had plasma samples for VeriStrat classification: good (VeriStrat Good [VSG]) or poor (VeriStrat Poor [VSP', 'VSG patients', 'patients with untreated advanced NSCLC considered unfit for platinum chemotherapy because of poor performance status (PS) or multiple comorbidities', 'Fifty-five percent patients had VSG, and 83% had Eastern Cooperative Oncology Group (ECOG', 'patients with NSCLC who had poor PS']","['placebo', 'oral erlotinib or placebo', 'active supportive care (ASC']","['median survival', 'long survival', 'survival', 'overall survival', '2-year survival', 'adjusted hazard ratio (HR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0430797', 'cui_str': 'Intracranial EEG'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",527.0,0.359436,"The association was consistent across patient factors: HR = 0.25 (p = 0.004) and HR = 0.56 (p < 0.001) for ECOG 0-1 and 2-3, respectively, HR = 0.49 (0070 ","[{'ForeName': 'Siow Ming', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': 'University College London Hospitals, London, UK; London Lung Cancer Group, London, UK; Cancer Research UK Lung Cancer Centre of Excellence, UCL, London, UK. Electronic address: sm.lee@nhs.net.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Upadhyay', 'Affiliation': 'Castle Hill Hospital, Hull, UK.'}, {'ForeName': 'Conrad', 'Initials': 'C', 'LastName': 'Lewanski', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'Bristol Cancer Institute, Bristol, UK.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Skailes', 'Affiliation': 'Lancashire Teaching Hospitals, Lancashire, UK.'}, {'ForeName': 'Penella J', 'Initials': 'PJ', 'LastName': 'Woll', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hatton', 'Affiliation': 'Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Lal', 'Affiliation': ""Guys and St Thomas' NHS Trust, London, UK.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Toy', 'Affiliation': 'Royal Devon and Exeter Foundation NHS Trust, Exeter, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Rudd', 'Affiliation': 'London Lung Cancer Group, London, UK.'}, {'ForeName': 'Yenting', 'Initials': 'Y', 'LastName': 'Ngai', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, UCL, London, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Edwards', 'Affiliation': 'DataNova Ltd, London, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hackshaw', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, UCL, London, UK.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.07.025']
1664,31499383,Impact of dose and duration of therapy on dexamethasone pharmacokinetics in childhood acute lymphoblastic leukaemia-a report from the UKALL 2011 trial.,"INTRODUCTION


The use of dexamethasone in acute lymphoblastic leukaemia therapy contributes to short- and long-term toxicities. The UKALL 2011 randomised trial investigated whether a more intense dexamethasone dose (10 mg/m 2 /d x 14d, short vs 6 mg/m 2 /d x 28d, standard) would lead to a more rapid cytoreduction and reduced adverse effects associated with longer durations of steroids in induction. The impact of dose and duration on dexamethasone pharmacokinetics was investigated.
METHODS


Blood samples were obtained on one of the first three and last three days of induction dexamethasone dosing at time points up to 8 h after oral administration. Plasma dexamethasone levels were quantified in 1084 plasma samples obtained from 174 children and a population pharmacokinetic model developed.
RESULTS


Drug exposure varied significantly between patients, with a >12-fold variation in AUC 0-12h  values and a marked overlap in dexamethasone exposures between dose levels. Intuitively, AUC 0-12h  was significantly higher with short dosing (10 mg/m 2 /d), but cumulative exposure was significantly higher with standard dosing over 28 days, after a higher cumulative dose. Concomitant rasburicase administration was associated with a 60% higher dexamethasone clearance. Day 8 bone marrow response was comparable between dosing arms, but those with <5% blast count exhibited a greater mean dexamethasone exposure than those with >5%. No statistical differences were observed between arms in terms of steroid-related toxicity or minimal residual disease at the end of induction.
CONCLUSION


The potential significance of dexamethasone AUC 0-12h  on early response and higher cumulative exposure on the standard arm suggest that duration of therapy and exposure may be more important factors than absolute dose from a clinical pharmacology perspective.",2019,"No statistical differences were observed between arms in terms of steroid-related toxicity or minimal residual disease at the end of induction.
",['childhood acute lymphoblastic leukaemia'],"['dexamethasone pharmacokinetics', 'dexamethasone', 'dexamethasone AUC', 'induction dexamethasone']","['dexamethasone clearance', 'cumulative exposure', 'bone marrow response', 'Plasma dexamethasone levels']","[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia, disease (disorder)'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",2011.0,0.0731507,"No statistical differences were observed between arms in terms of steroid-related toxicity or minimal residual disease at the end of induction.
","[{'ForeName': 'Rosanna K', 'Initials': 'RK', 'LastName': 'Jackson', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle University, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Liebich', 'Affiliation': 'Department of Pharmaceutical and Medical Chemistry, Clinical Pharmacy, University of Münster, Germany.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Berry', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle University, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Errington', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle University, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Jizhong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, UK.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Parker', 'Affiliation': 'Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Moppett', 'Affiliation': 'Department of Paediatric Haematology and Oncology, Bristol Royal Hospital for Children, UK.'}, {'ForeName': 'Sujith', 'Initials': 'S', 'LastName': 'Samarasinghe', 'Affiliation': 'Department of Haematology, Great Ormond Street Hospital for Children, London, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Hough', 'Affiliation': 'University College Hospital, London, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Rowntree', 'Affiliation': 'University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Nick J', 'Initials': 'NJ', 'LastName': 'Goulden', 'Affiliation': 'Department of Haematology, Great Ormond Street Hospital for Children, London, UK.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Vora', 'Affiliation': 'Department of Paediatric Haematology, Great Ormond Street Hospital, UK.'}, {'ForeName': 'Pamela R', 'Initials': 'PR', 'LastName': 'Kearns', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, Institute of Cancer and Genomic Studies, University of Birmingham, UK.'}, {'ForeName': 'Vaskar', 'Initials': 'V', 'LastName': 'Saha', 'Affiliation': 'Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, UK; Tata Translational Cancer Research Centre, Tata Medical Center, Kolkata, India.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Hempel', 'Affiliation': 'Department of Pharmaceutical and Medical Chemistry, Clinical Pharmacy, University of Münster, Germany.'}, {'ForeName': 'Julie A E', 'Initials': 'JAE', 'LastName': 'Irving', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle University, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Veal', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle University, Newcastle Upon Tyne, UK. Electronic address: G.J.Veal@ncl.ac.uk.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.07.026']
1665,32416635,The efficacy and safety of fractional radiofrequency nanoneedle system in the treatment of atrophic acne scars in Asians.,"BACKGROUND


Multiple treatment modalities have been developed to treat atrophic acne scars with varying degrees of success. Post-inflammatory hyperpigmentation (PIH) after acne scar treatments remain a major concern in Asian patients. Fractional radiofrequency (FRF) has been used in many dermatological skin conditions including acne scars.
OBJECTIVE


To determine the efficacy and safety of FRF nanoneedle system in the treatment of acne scars in Asians.
METHODS


This is a prospective, evaluator-blinded study with 25 subjects diagnosed with moderate to severe acne scarring. All subjects received 3 monthly treatments of the FRF nanoneedle system on both cheeks. Primary outcome was the clinical improvement of acne scars graded by 2 blinded dermatologists at baseline, 1-, 3- and 6-month follow-up. Objective scar volume analysis was done using ultraviolet A (UVA) light video camera. Subjects' self-assessment, pain score and adverse events were also recorded.
RESULTS


Twenty-three out of 25 subjects completed the study and attended all follow-up. Clinical improvement of acne scars was observed as early as 1-month follow-up. Objective evaluation of acne scar volume decreased significantly on all follow-up compared to baseline (p<0.005). Majority of the subjects (48%) reported marked improvement in their acne scars. Adverse events such as pain, erythema, burning sensation, edema, scab formation and PIH were mild and temporary.
CONCLUSIONS


FRF nanoneedle system is a safe and effective treatment for acne scars in Asians. However, despite the significant changes in the scar volume, caution should be used to avoid excessive coagulation resulting in PIH.",2020,Objective evaluation of acne scar volume decreased significantly on all follow-up compared to baseline (p<0.005).,"['Asian patients', 'acne scars in Asians', '25 subjects diagnosed with moderate to severe acne scarring', 'Twenty-three out of 25 subjects completed the study and attended all follow-up', 'atrophic acne scars in Asians']","['ultraviolet A (UVA) light video camera', 'FRF nanoneedle system', 'fractional radiofrequency nanoneedle system', 'Fractional radiofrequency (FRF']","['clinical improvement of acne scars graded by 2 blinded dermatologists', 'acne scars', 'acne scar volume', ""Subjects' self-assessment, pain score and adverse events"", 'Adverse events such as pain, erythema, burning sensation, edema, scab formation and PIH were mild and temporary', 'efficacy and safety']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0423783', 'cui_str': 'Acne scar'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1274728', 'cui_str': 'Atrophic acne scar'}]","[{'cui': 'C1532472', 'cui_str': 'Ultra-violet'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0423783', 'cui_str': 'Acne scar'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0259831', 'cui_str': 'Dermatologist'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0074125', 'cui_str': 'SCAB protocol'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",25.0,0.0167839,Objective evaluation of acne scar volume decreased significantly on all follow-up compared to baseline (p<0.005).,"[{'ForeName': 'Sunatra', 'Initials': 'S', 'LastName': 'Nitayavardhana', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Rungsima', 'Initials': 'R', 'LastName': 'Wanitphakdeedecha', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Janice Natasha C', 'Initials': 'JNC', 'LastName': 'Ng', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sasima', 'Initials': 'S', 'LastName': 'Eimpunth', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Woraphong', 'Initials': 'W', 'LastName': 'Manuskiatti', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13484']
1666,31558370,Effect of the Emotional Freedom Techniques on anger symptoms in Hwabyung patients: A comparison with the progressive muscle relaxation technique in a pilot randomized controlled trial.,"CONTEXT


Hwabyung is a psychosomatic disease resulting from the suppression of anger over an extended period. The Emotional Freedom Techniques (EFT) are meridian-based psychotherapy known to cure many psychosomatic diseases, and progressive muscle relaxation (PMR) is a therapeutic method that relieves physical and psychological tension by repeated tensing and relaxation of the muscles.
OBJECT


In this study, we compared the effects of EFT and PMR in patients with Hwabyung.
DESIGN


40 patients were enrolled and randomized to receive 4 weeks of group sessions with either EFT (n = 20) or PMR (n = 20). Evaluations were conducted pre- and post-treatment and at 4-week and 24-week follow-ups after session end.
MAIN OUTCOME MEASURES


The Hwabyung Scale, Visual Analogue Scale of Hwabyung Symptoms (VAS-HS), Beck Depression Inventory (BDI), State-Trait Anxiety Inventory (STAI), and State-Trait Anger Expression Inventory (STAXI) were administered as self-report tools. The analysis excluded 8 patients who never attended treatment and 1 patient meeting the exclusion criteria.
RESULT


EFT (n = 15) and PMR (n = 16) improved Hwabyung symptoms (-13.95% and -11.46%, respectively), state anxiety (-12.57% and -12.64%, respectively), and depression (-32.11% and -18.68%, respectively) (p < 0.05 for all). Trait anger improved in EFT group (-13.4%, p = 0.004). There were no significant differences between the groups (p > 0.05) except for trait anger at post-treatment (p = 0.022 for between group). No adverse events were reported during the study.",2020,There were no significant differences between the groups (p > 0.05) except for trait anger at post-treatment (p = 0.022 for between group).,"['8 patients who never attended treatment and 1 patient meeting the exclusion criteria', 'Hwabyung patients', '40 patients', 'patients with Hwabyung']","['EFT and PMR', 'PMR', 'EFT', 'Emotional Freedom Techniques', 'progressive muscle relaxation technique']","['Hwabyung symptoms', 'PMR', 'adverse events', 'Hwabyung Scale, Visual Analogue Scale of Hwabyung Symptoms (VAS-HS), Beck Depression Inventory (BDI), State-Trait Anxiety Inventory (STAI), and State-Trait Anger Expression Inventory (STAXI', 'depression', 'anger symptoms', 'state anxiety', 'Trait anger', 'trait anger']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0004361', 'cui_str': 'Progressive Relaxation'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0222045'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory (assessment scale)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0002957', 'cui_str': 'Anger'}]",40.0,0.0339094,There were no significant differences between the groups (p > 0.05) except for trait anger at post-treatment (p = 0.022 for between group).,"[{'ForeName': 'Hui-Yong', 'Initials': 'HY', 'LastName': 'Kwak', 'Affiliation': 'Department of Neuropsychiatry, Graduate School, Kyung Hee University, 1, Kyungheedae-ro, Dongdaemun-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Eun-Ji', 'Initials': 'EJ', 'LastName': 'Choi', 'Affiliation': 'Haneum Neuropsychiatry Clinic of Korean Medicine, 1426, Jungang-ro, Ilsanseo-gu, Goyang-si, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Jong-Woo', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Neuropsychiatry, College of Korean Medicine, Kyung Hee University, 1, Kyungheedae-ro, Dongdaemun-gu, Seoul, Republic of Korea; Department of Korean Neuropsychiatry, Gangdong Kyung Hee University Hospital, 892 Dongnam-ro, Gangdong-gu, Seoul 05278, Republic of Korea.'}, {'ForeName': 'Hyo-Weon', 'Initials': 'HW', 'LastName': 'Suh', 'Affiliation': 'Department of Neuropsychiatry, Graduate School, Kyung Hee University, 1, Kyungheedae-ro, Dongdaemun-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Sun-Yong', 'Initials': 'SY', 'LastName': 'Chung', 'Affiliation': 'Department of Neuropsychiatry, College of Korean Medicine, Kyung Hee University, 1, Kyungheedae-ro, Dongdaemun-gu, Seoul, Republic of Korea; Department of Korean Neuropsychiatry, Gangdong Kyung Hee University Hospital, 892 Dongnam-ro, Gangdong-gu, Seoul 05278, Republic of Korea. Electronic address: lovepwr@khu.ac.kr.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2019.08.006']
1667,31549861,"The effects of an expressive writing intervention on pregnancy rates, alexithymia and psychophysical health during an assisted reproductive treatment.","Objective:  World Health Organization reported that in developed countries one in four couples experience infertility with serious implications for the psychophysical well-being. Aim of this study was to evaluate the effects of Pennebaker's writing technique on pregnancy rates, alexithymia and psychophysical health during an assisted reproductive treatment (ART). Method:  91 women admitted for an ART were randomly divided into two groups: an experimental one ( n  = 46), where women wrote about their thoughts and emotions concerning the infertility experience, and a control group ( n  = 45) where women did not write. All subjects completed a socio-demographic questionnaire, the 20-item Toronto Alexithymia Scale and the Symptoms Checklist-90-R before and after the writing sessions. Results:  A significant difference in pregnancy rates between the experimental group ( n  = 13) and the control group ( n  = 5) was found (χ 2  = 4.216;  p  < .04). A significant difference was also found between women who participated in the study (experimental + control= 91) and women who declined to participate, in the direction of more ART successes ( n  = 18 vs.  n  = 0) in the group of women who participated (χ 2  = 10.17;  p  < .01). Conclusions:  The findings support the usefulness of the writing technique during ART in promoting treatment success.",2020,A significant difference in pregnancy rates between the experimental group ( n  = 13) and the control group ( n  = 5) was found (χ 2  = 4.216;  p  < .04).,['91 women admitted for an ART'],"[""Pennebaker's writing technique"", 'women wrote about their thoughts and emotions concerning the infertility experience, and a control group', 'expressive writing intervention']","['pregnancy rates', 'ART successes', 'pregnancy rates, alexithymia and psychophysical health', 'socio-demographic questionnaire, the 20-item Toronto Alexithymia Scale and the Symptoms Checklist-90-R']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0002020', 'cui_str': 'Alexithymia'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0222045'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist (assessment scale)'}]",91.0,0.0358192,A significant difference in pregnancy rates between the experimental group ( n  = 13) and the control group ( n  = 5) was found (χ 2  = 4.216;  p  < .04).,"[{'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Renzi', 'Affiliation': 'Department of Dynamic and Clinical Psychology, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Solano', 'Affiliation': 'Department of Dynamic and Clinical Psychology, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Di Trani', 'Affiliation': 'Department of Dynamic and Clinical Psychology, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Ginobbi', 'Affiliation': 'Casamadre Association, Rome, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Minutolo', 'Affiliation': 'Department of Reproductive Medicine, Altamedica-Artemisia SpA, Rome, Italy.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Tambelli', 'Affiliation': 'Department of Dynamic and Clinical Psychology, Sapienza University of Rome, Rome, Italy.'}]",Psychology & health,['10.1080/08870446.2019.1667500']
1668,32416611,A comparative clinical & histopathological pilot study of different fractional CO2 laser parameters in treatment of atrophic linear scars.,"BACKGROUND


Atrophic scars cause significant patient morbidity. Fractional photothermolysis is one of the most effective treatment options used to resurface scars of different aetiologies.
OBJECTIVES


To assess the efficacy and safety of different fractional ablative CO 2  Laser parameters in treatment of linear atrophic depressed post-traumatic facial scars in adult male patients.
METHODS


A prospective pilot study of 20 adult male patients (skin types Π- Ⅳ, aged 18-45) with post traumatic atrophic linear scars were divided into 2 groups each comprising 10 patients receiving different fractional CO2 laser parameters. Both groups received 3 laser sessions; one month apart and were followed for 2 months after the last treatment session. Clinical and histological assessments were done to all patients before treatment and 2 months after the last treatment session. Also, patient satisfaction and side effects were recorded.
RESULTS


The study showed statistically significant reduction in average scar volume in both groups (p< 0.01); with reduction in depth more obvious than reduction in width or length in both groups. There was a highly significant difference in overall scar improvement represented by scar volume between both groups (P<0.01) with an average reduction in scar volume of 42.85 % in group (1) compared to 35.29 % in group (2). Also, there was a highly statistically significant increase in both epidermal, papillary and reticular dermis thickness in both groups after treatment. However, the difference between both groups was non-significant. Side effects were mild, well tolerated and transient.
CONCLUSION


Fractional CO 2  laser can be utilized as a safe and effective modality in treatment of post traumatic linear atrophic scars of the face. Adjusting parameters towards increasing depth of penetration and decreasing thermal coagulative effect gives better results.",2020,There was a highly significant difference in overall scar improvement represented by scar volume between both groups (P<0.01) with an average reduction in scar volume of 42.85 % in group (1) compared to 35.29 % in group (2).,"['20 adult male patients (skin types Π- Ⅳ, aged 18-45) with post traumatic atrophic linear scars', 'atrophic linear scars', 'linear atrophic depressed post-traumatic facial scars in adult male patients']","['fractional ablative CO 2  Laser parameters', 'fractional CO2 laser parameters']","['average scar volume', 'scar volume', 'patient satisfaction and side effects', 'both epidermal, papillary and reticular dermis thickness', 'efficacy and safety', 'tolerated and transient', 'width or length', 'overall scar improvement']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C2229249', 'cui_str': 'Scar of face'}]","[{'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]","[{'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C0439739', 'cui_str': 'Reticular'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",20.0,0.01976,There was a highly significant difference in overall scar improvement represented by scar volume between both groups (P<0.01) with an average reduction in scar volume of 42.85 % in group (1) compared to 35.29 % in group (2).,"[{'ForeName': 'Ahmed I', 'Initials': 'AI', 'LastName': 'Rashid', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Ain Shams University.'}, {'ForeName': 'Sylvia A', 'Initials': 'SA', 'LastName': 'Shawky', 'Affiliation': 'Faculty of medicine, Ain shams university.'}, {'ForeName': 'Rabab', 'Initials': 'R', 'LastName': 'Ghareeb', 'Affiliation': 'Pathology, faculty of medicine, Ain Shams University.'}, {'ForeName': 'Manal A', 'Initials': 'MA', 'LastName': 'Sharara', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Ain Shams University.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13489']
1669,30922751,Changes in vascular and inflammatory biomarkers after exercise rehabilitation in patients with symptomatic peripheral artery disease.,"OBJECTIVE


Home-based exercise is an alternative exercise mode to a structured supervised program to improve symptoms in patients with peripheral artery disease (PAD), but little is known about whether the slow-paced and less intense home program also elicits changes in vascular and inflammatory biomarkers. In an exploratory analysis from a randomized controlled trial, we compared changes in vascular and inflammatory biomarkers in patients with symptomatic PAD (typical and atypical of claudication) after home-based exercise and supervised exercise programs and in an attention-control group.
METHODS


A total of 114 patients were randomized into one of the three groups (n = 38 per group). Two groups performed exercise interventions, consisting of home-based and supervised programs of intermittent walking to mild to moderate claudication pain for 12 weeks; a third group performed light resistance training as a nonwalking attention-control group. Before and after intervention, patients were characterized on treadmill performance and endothelial effects of circulating factors present in sera by a cell culture-based bioassay on primary human arterial endothelial cells, and they were further evaluated on circulating vascular and inflammatory biomarkers.
RESULTS


Treadmill peak walking time increased (P = .008) in the two exercise groups but not in the control group (P > .05). Cultured endothelial cell apoptosis decreased after home-based exercise (P < .001) and supervised exercise (P = .007), and the change in the exercise groups combined was different from that in the control group (P = .005). For circulating biomarkers, increases were found in hydroxyl radical antioxidant capacity (P = .003) and vascular endothelial growth factor A (P = .037), and decreases were observed in E-selectin (P = .007) and blood glucose concentration (P = .012) after home-based exercise only. The changes in hydroxyl radical antioxidant capacity (P = .005), vascular endothelial growth factor A (P = .008), and E-selectin (P = .034) in the exercise groups combined were different from those in the control group.
CONCLUSIONS


This exploratory analysis found that both home-based and supervised exercise programs are efficacious to decrease cultured endothelial cell apoptosis in patients with symptomatic PAD. Furthermore, a monitored home-based exercise program elicits additional vascular benefits by improving circulating markers of endogenous antioxidant capacity, angiogenesis, endothelium-derived inflammation, and blood glucose concentration in patients with symptomatic PAD. The novel clinical significance is that important trends were found in this exploratory analysis that a contemporary home-based exercise program and a traditional supervised exercise program may favorably improve vascular and inflammatory biomarkers in addition to the well-described ambulatory improvements in symptomatic patients with PAD.",2019,"For circulating biomarkers, increases were found in hydroxyl radical antioxidant capacity (P = .003) and vascular endothelial growth factor A (P = .037), and decreases were observed in E-selectin (P = .007) and blood glucose concentration (P = .012) after home-based exercise only.","['patients with symptomatic PAD', 'A total of 114 patients', 'patients with symptomatic peripheral artery disease', 'patients with peripheral artery disease (PAD', 'symptomatic patients with PAD', 'patients with symptomatic PAD (typical and atypical of claudication) after home-based']","['exercise interventions, consisting of home-based and supervised programs of intermittent walking to mild to moderate claudication pain for 12\xa0weeks; a third group performed light resistance training as a nonwalking attention-control group', 'exercise and supervised exercise programs and in an attention-control group']","['E-selectin', 'hydroxyl radical antioxidant capacity', 'supervised exercise', 'vascular endothelial growth factor A', 'Cultured endothelial cell apoptosis', 'blood glucose concentration', 'Treadmill peak walking time', 'circulating markers of endogenous antioxidant capacity, angiogenesis, endothelium-derived inflammation, and blood glucose concentration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C1456822', 'cui_str': 'Claudication'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1456822', 'cui_str': 'Claudication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0115305', 'cui_str': 'LECAM-2'}, {'cui': 'C0063146', 'cui_str': 'Hydroxyl'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0225336', 'cui_str': 'Endothelial Cells'}, {'cui': 'C0162638', 'cui_str': 'Programmed Cell Death, Type I'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0014257', 'cui_str': 'Endothelium'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",114.0,0.0401821,"For circulating biomarkers, increases were found in hydroxyl radical antioxidant capacity (P = .003) and vascular endothelial growth factor A (P = .037), and decreases were observed in E-selectin (P = .007) and blood glucose concentration (P = .012) after home-based exercise only.","[{'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Gardner', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Penn State College of Medicine, Hershey, Pa. Electronic address: agardner4@pennstatehealth.psu.edu.'}, {'ForeName': 'Donald E', 'Initials': 'DE', 'LastName': 'Parker', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of Oklahoma Health Sciences Center, Oklahoma City, Okla.'}, {'ForeName': 'Polly S', 'Initials': 'PS', 'LastName': 'Montgomery', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Penn State College of Medicine, Hershey, Pa.'}]",Journal of vascular surgery,['10.1016/j.jvs.2018.12.056']
1670,31482853,Family Separation and the Impact of Digital Technology on the Mental Health of Refugee Families in the United States: Qualitative Study.,"BACKGROUND


Conflicts around the world have resulted in a record high number of refugees. Family separation is a critical factor that impacts refugee mental health. Thus, it is important to explore refugees' ability to maintain contact with family members across the globe and the ways in which they attempt to do so. It is increasingly common for refugees to use information and communication technologies (ICTs), which include mobile phones, the internet, and social media sites, such as Facebook, WhatsApp, Skype, and Viber, for these purposes.
OBJECTIVE


The aim of this study was to explore refugees' perceptions of the impact of communication through ICTs on their mental health, the exercise of agency by refugees within the context of ICT use, especially their communication with their families, and logistical issues that affect their access to ICTs in the United States.
METHODS


We used a constructivist grounded theory approach to analyze in-depth interviews of 290 adult refugee participants from different countries, who were enrolled in a randomized controlled trial of a community-based mental health intervention.
RESULTS


Analyses showed that communication through ICTs had differing impacts on the mental health of refugee participants. ICTs, as channels of communication between separated families, were a major source of emotional and mental well-being for a large number of refugee participants. However, for some participants, the communication process with separated family members through digital technology was mentally and emotionally difficult. The participants also discussed ways in which they hide adversities from their families through selective use of different ICTs. Several participants noted logistical and financial barriers to communicating with their families through ICTs.
CONCLUSIONS


These findings are important in elucidating aspects of refugee agency and environmental constraints that need to be further explicated in theories related to ICT use as well as in providing insight for researchers and practitioners involved in efforts related to migration and mental health.",2019,"ICTs, as channels of communication between separated families, were a major source of emotional and mental well-being for a large number of refugee participants.",['290 adult refugee participants from different countries'],"['Digital Technology', 'community-based mental health intervention']",['mental health'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",290.0,0.0560477,"ICTs, as channels of communication between separated families, were a major source of emotional and mental well-being for a large number of refugee participants.","[{'ForeName': 'Sayyed Fawad Ali', 'Initials': 'SFA', 'LastName': 'Shah', 'Affiliation': 'Department of Communication, Jacksonville State University, Jacksonville, AL, United States.'}, {'ForeName': 'Julia Meredith', 'Initials': 'JM', 'LastName': 'Hess', 'Affiliation': 'Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, NM, United States.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Goodkind', 'Affiliation': 'Department of Sociology, University of New Mexico, Albuquerque, NM, United States.'}]",Journal of medical Internet research,['10.2196/14171']
1671,31479947,Quality of surgery and surgical reporting for patients with primary gastrointestinal stromal tumours participating in the EORTC STBSG 62024 adjuvant imatinib study.,"BACKGROUND


EORTC (European Organisation of Research and Treatment of Cancer) 62024 is a phase III randomised trial evaluating adjuvant imatinib in patients with gastrointestinal stromal tumours (GISTs) and no evidence of residual disease after surgery in 908 patients from 11 countries participated. As surgical treatment aspects (tumour rupture and incomplete resection) contribute to the risk of recurrence, the data of primary surgery were reviewed.
METHODS


The surgical record, local pathology report and a surgical questionnaire on details of the operation had to be completed when patients entered the study. Surgeons from 5 countries, covering 8 languages, reviewed the full set of data being available from 793 patients (87.3%).
RESULTS


A known GIST was the reason for surgery in only 58% of the cases, and 12% of the patients were treated as an emergency. The R0-resection rate was 87%. The extent of resection was local excision in 17%, segmental resection in 59%, full-organ resection in 11% and multivisceral resection in 11%, with lymphadenectomy performed in 24% of the patients. Shelling out of the tumour was performed in 9.7%, and the proportion of tumours removed in parts was higher in the endoscopy/laparoscopy group. The incidence of tumour rupture (representing M1) was 9%. The consistency between preoperative and intraoperative findings was 82%. The postoperative complication rate was 7.3%.
CONCLUSION


The standardisation of surgery in this study was inferior. Given the review data, 18% of the patients should not have participated in the trial. Quality of surgery and improperly reported intraoperative details might influence the trial results. A detailed surgical questionnaire filled out by the surgeon is mandatory before entering the patient in an adjuvant trial in GIST.",2019,62024 is a phase III randomised trial evaluating adjuvant imatinib in patients with gastrointestinal stromal tumours (GISTs) and no evidence of residual disease after surgery in 908 patients from 11 countries participated.,"['Cancer', 'patients with primary gastrointestinal stromal tumours\xa0participating in the EORTC STBSG 62024 adjuvant imatinib study', 'patients with gastrointestinal stromal tumours (GISTs) and no evidence of residual disease after surgery in 908 patients from 11 countries participated']",['adjuvant imatinib'],"['postoperative complication rate', 'full-organ resection', 'R0-resection rate', 'incidence of tumour rupture', 'Quality of surgery and surgical reporting']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal Stromal Tumors'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332125', 'cui_str': 'No evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0935989', 'cui_str': 'imatinib'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2938957', 'cui_str': 'Tumour rupture'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",908.0,0.0413268,62024 is a phase III randomised trial evaluating adjuvant imatinib in patients with gastrointestinal stromal tumours (GISTs) and no evidence of residual disease after surgery in 908 patients from 11 countries participated.,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hohenberger', 'Affiliation': 'Division of Surgical Oncology & Thoracic Surgery, Mannheim University Medical Center, University of Heidelberg, Germany. Electronic address: peter.hohenberger@umm.de.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Bonvalot', 'Affiliation': 'Department of Surgery, Department of Surgery, Institut Curie, PSL University, Paris, France.'}, {'ForeName': 'Frits', 'Initials': 'F', 'LastName': 'van Coevorden', 'Affiliation': 'Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Pjotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Memorial Center and Institute of Oncology, Roentgen Str 5, 02-781, Warsaw, Poland.'}, {'ForeName': 'Eberhard', 'Initials': 'E', 'LastName': 'Stoeckle', 'Affiliation': ""Surgery Department, Institut Bergonie, 229 Cours de L'Argonne, 33000 Bordeaux, France.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Olungu', 'Affiliation': 'Department of Biostatistics, European Organization for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Litiere', 'Affiliation': 'Department of Biostatistics, European Organization for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Wardelmann', 'Affiliation': 'Gerhard-Domagk-Institute of Pathology, University of Münster Medical Center, Münster, Germany.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Gronchi', 'Affiliation': 'Department of Surgery, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Casali', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.07.028']
1672,31336289,Ten-year results of the Multicentric Italian Lung Detection trial demonstrate the safety and efficacy of biennial lung cancer screening.,"BACKGROUND


The Multicentric Italian Lung Detection (MILD) trial demonstrated that prolonged low-dose computed tomography (LDCT) screening could achieve a 39% reduction in lung cancer (LC) mortality. We have here evaluated the long-term results of annual vs. biennial LDCT and the impact of screening intensity on overall and LC-specific mortality at 10 years.
PATIENTS AND METHODS


Between 2005 and 2018, the MILD trial prospectively randomised the 2376 screening arm participants to annual (n = 1190) or biennial (n = 1186) LDCT, for a median screening period of 6.2 years and 23,083 person-years of follow-up. The primary outcomes were 10-year overall and LC-specific mortality, and the secondary end-points were the frequency of advanced-stage and interval LCs.
RESULTS


The biennial LDCT arm showed a similar overall mortality (hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.57-1.12) and LC-specific mortality at 10 years (HR 1.10, 95% CI 0.59-2.05), as compared with the annual LDCT arm. Biennial screening saved 44% of follow-up LDCTs in subjects with negative baseline LDCT, and 38% of LDCTs in all participants, with no increase in the occurrence of stage II-IV or interval LCs.
CONCLUSIONS


The MILD trial provides original evidence that prolonged screening beyond five years with biennial LDCT can achieve an LC mortality reduction comparable to annual LDCT, in subjects with a negative baseline examination.",2019,"The biennial LDCT arm showed a similar overall mortality (hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.57-1.12) and LC-specific mortality at 10 years (HR 1.10, 95% CI 0.59-2.05), as compared with the annual LDCT arm.","['2376 screening arm participants to annual (n\xa0=\xa01190) or biennial (n\xa0=\xa01186', 'Between 2005 and 2018']","['biennial lung cancer screening', 'prolonged low-dose computed tomography (LDCT) screening', 'LDCT']","['LC-specific mortality', 'occurrence of stage II-IV or interval LCs', 'overall mortality', '10-year overall and LC-specific mortality, and the secondary end-points were the frequency of advanced-stage and interval LCs', 'LC mortality reduction', 'lung cancer (LC) mortality', 'safety and efficacy']","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}]","[{'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.365754,"The biennial LDCT arm showed a similar overall mortality (hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.57-1.12) and LC-specific mortality at 10 years (HR 1.10, 95% CI 0.59-2.05), as compared with the annual LDCT arm.","[{'ForeName': 'U', 'Initials': 'U', 'LastName': 'Pastorino', 'Affiliation': 'Thoracic Surgery Unit, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy. Electronic address: ugo.pastorino@istitutotumori.mi.it.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Sverzellati', 'Affiliation': 'Section of Radiology, Unit of Surgical Sciences, Department of Medicine and Surgery (DiMeC), University of Parma, Parma, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sestini', 'Affiliation': 'Thoracic Surgery Unit, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Silva', 'Affiliation': 'Section of Radiology, Unit of Surgical Sciences, Department of Medicine and Surgery (DiMeC), University of Parma, Parma, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Sabia', 'Affiliation': 'Thoracic Surgery Unit, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boeri', 'Affiliation': 'Tumor Genomics Unit, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cantarutti', 'Affiliation': 'Department of Statistics and Quantitative Methods, Division of Biostatistics, Epidemiology and Public Health, University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sozzi', 'Affiliation': 'Tumor Genomics Unit, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Corrao', 'Affiliation': 'Department of Statistics and Quantitative Methods, Division of Biostatistics, Epidemiology and Public Health, University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Marchianò', 'Affiliation': 'Department of Radiology, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.06.009']
1673,31206588,Follow-Up of a Virtual-Group-Exercise at Home Program to Reduce Fall Risks.,,2019,,[],[],[],[],[],[],,0.0125858,,"[{'ForeName': 'Machiko R', 'Initials': 'MR', 'LastName': 'Tomita', 'Affiliation': 'Department of Rehabilitations Science, University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Nadine M', 'Initials': 'NM', 'LastName': 'Fisher', 'Affiliation': 'Department of Rehabilitations Science, University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ramsey', 'Affiliation': ""Health Professional Education, D'Youville College, Buffalo, New York.""}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Stanton', 'Affiliation': 'Aging & Technology Research Center, University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Bruce J', 'Initials': 'BJ', 'LastName': 'Naughton', 'Affiliation': 'Department of Medicine, University at Buffalo, Buffalo, New York.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.15992']
1674,31445198,SAPPHIRE: a randomised phase II study of planned discontinuation or continuous treatment of oxaliplatin after six cycles of modified FOLFOX6 plus panitumumab in patients with colorectal cancer.,"BACKGROUND


Fluorouracil (5-FU), leucovorin (LV) and oxaliplatin (FOLFOX) plus panitumumab therapy is a commonly used first-line chemotherapy for metastatic colorectal cancer (mCRC). However, the long-term administration of oxaliplatin is associated with peripheral neuropathy (PN). We investigated whether the planned discontinuation of oxaliplatin after FOLFOX plus panitumumab therapy can maintain efficacy and reduce PN incidence.
PATIENTS AND METHODS


Chemotherapy-naive patients with RAS wild-type mCRC, aged ≥20 years, were enrolled and received six cycles of modified FOLFOX6 (mFOLFOX6) plus panitumumab as induction therapy. Patients who completed induction therapy without progression were randomised to mFOLFOX6 plus panitumumab (group A) or to 5-FU/LV plus panitumumab (group B). The primary end-point was the progression-free survival (PFS) rate at 9 months after randomisation. The secondary end-points were PFS, overall survival (OS), time to treatment failure (TTF), response rate (RR) and safety.
RESULTS


In total, 164 patients were enrolled; of whom, 113 patients were then randomised (group A, n = 56; group B, n = 57). The median follow-up after randomisation was 19.6 months. The PFS rates at 9 months and median PFS were 46.4% (80% confidence interval [CI], 38.1-54.9) and 9.1 months (95% CI, 8.6-11.1) in group A, compared with 47.4% (80% CI, 39.1-55.8) and 9.3 months (95% CI, 6.0-13.0) in group B, respectively. RR, OS and TTF were also similar in both groups. Grade ≥2 PN incidence was lower in group B (9.3%) than in group A (35.7%).
CONCLUSION


Planned discontinuation of oxaliplatin after six cycles of mFOLFOX6 plus panitumumab is a potential treatment option in patients with mCRC, achieving similar efficacy while reducing oxaliplatin-associated PN compared with mFOLFOX6 plus panitumumab.
TRIAL REGISTRATION NUMBER


NCT02337946.",2019,"Grade ≥2 PN incidence was lower in group B (9.3%) than in group A (35.7%).
","['metastatic colorectal cancer (mCRC', 'Chemotherapy-naive patients with RAS wild-type mCRC, aged ≥20 years', 'Patients who completed induction therapy without progression', '164 patients were enrolled; of whom, 113 patients', 'patients with colorectal cancer', 'patients with mCRC']","['5-FU/LV plus panitumumab', 'modified FOLFOX6 (mFOLFOX6) plus panitumumab', 'oxaliplatin after FOLFOX plus panitumumab therapy', 'Fluorouracil (5-FU), leucovorin (LV) and oxaliplatin (FOLFOX) plus panitumumab therapy', 'oxaliplatin', 'modified FOLFOX6 plus panitumumab', 'mFOLFOX6 plus panitumumab']","['median PFS', 'RR, OS\xa0and TTF', 'progression-free survival (PFS) rate', 'PFS rates', 'Grade ≥2\xa0PN incidence', 'PFS, overall survival (OS), time to treatment failure (TTF), response rate (RR)\xa0and safety']","[{'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C3494202', 'cui_str': 'Time-to-Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",164.0,0.301007,"Grade ≥2 PN incidence was lower in group B (9.3%) than in group A (35.7%).
","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Munemoto', 'Affiliation': 'Department of Surgery, Fukui-ken Saiseikai Hospital, 7-1 Funabashi, Wadanaka-cho, Fukui City, Fukui, 918-8503, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Department of Multidisciplinary Treatment Cancer Center, Aizawa Hospital, 2-5-1 Honjou, Matsumoto City, Nagano, 390-8510, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': ""Department of Gastroenterological Surgery, Yokohama Municipal Citizen's Hospital, 56 Okazawa-cho, Hodogaya-ku, Yokohama City, Kanagawa, 240-8555, Japan.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kotaka', 'Affiliation': 'Gastrointestinal Cancer Center, Sano Hospital, 2-5-1 Shimizugaoka, Tarumi-ku, Kobe City, Hyogo, 655-0031, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kuroda', 'Affiliation': 'Department of Surgery, Kitakyushu General Hospital, 1-1 Higashijounomachi, Kokurakita-ku, Kitakyushu City, Fukuoka, 802-8517, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Surgery, National Hospital Organization Osaka National Hospital, 2 -1-14 Hoenzaka, Chuo-ku, Osaka City, Osaka, 540-0006, Japan; Department of Surgery, Kansai Rosai Hospital, 3 Chome-1-69 Inabaso, Amagasaki City, Hyogo, 660-8511, Japan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Minagawa', 'Affiliation': 'Department of Surgery 1, The University of Occupational and Environmental Health, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu City, Fukuoka, 807-8555, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Noura', 'Affiliation': 'Department of Surgery, Osaka Rosai Hospital, 1179-3 Nagasone-cho, Kita-ku, Sakai City, Osaka, 591-8025, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fukunaga', 'Affiliation': 'Department of Surgery, Hyogo Prefectural Nishinomiya Hospital, 13-9 Rokutanji-cho, Nishinomiya City, Hyogo, 662-0918, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kuramochi', 'Affiliation': ""Department of Chemotherapy Surgery, Tokyo Women's Medical University Yachiyo Medical Center, 477-96 Owada Shinden, Yachiyo City, Chiba, 276-8524, Japan.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Touyama', 'Affiliation': 'Department of Surgery, Nakagami Hospital, 610 Noborikawa, Okinawa City, Okinawa, 904-2195, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Department of Surgical Oncology, Gifu University Hospital, 1-1 Yanagido, Gifu City, Gifu, 501-1194, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Miwa', 'Affiliation': 'Department of Multidisciplinary Treatment Cancer Center, Kurume University Hospital, 67 Asahimachi, Kurume City, Fukuoka, 830-0011, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Satake', 'Affiliation': 'Department of Medical Oncology, Kobe City Medical Center General Hospital, 2-1-1 Minatojima Minamimachi, Chuo-ku, Kobe City, Hyogo, 650-0047, Japan; Cancer Treatment Center, Kansai Medical University Hospital, 2-3-1 Shinmachi, Hirakata City, Osaka, 573-1191, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kurosawa', 'Affiliation': 'Department of Japan Medical Affairs, Japan Oncology Business Unit, Takeda Pharmaceutical Company Limited, 2-1-1 Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-8668, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Miura', 'Affiliation': 'Department of Japan Medical Affairs, Japan Oncology Business Unit, Takeda Pharmaceutical Company Limited, 2-1-1 Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-8668, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Mishima', 'Affiliation': 'Cancer Center, Aichi Medical University, 1-1 Yazakokarimata, Nagakute City, Aichi, 480-1195, Japan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sakamoto', 'Affiliation': ""Hospital Director's Office, Tokai Central Hospital, 4-6-2 Sohara Higashijima-cho, Kakamigahara City, Gifu, 504-8601, Japan.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Oba', 'Affiliation': 'Department of Biostatistics, School of Public Health, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8654, Japan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Nagata', 'Affiliation': 'Department of Surgery, Kitakyushu General Hospital, 1-1 Higashijounomachi, Kokurakita-ku, Kitakyushu City, Fukuoka, 802-8517, Japan. Electronic address: n.nagata@kitakyu-hp.or.jp.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.07.006']
1675,31473130,Comparison of oral vs. combined topical/intravenous/oral tranexamic acid in the prevention of blood loss in total knee arthroplasty: A randomised clinical trial.,"BACKGROUND


Tranexamic acid (TXA) has long been used to reduce blood loss associated with total knee arthroplasty (TKA). Debate remains over the best administration route with limited data comparing regimes including, to date, no studies investigating the equivalence of oral TXA and a combined topical/intravenous (IV) regime. Therefore, the aim of this study was to compare the efficacy and safety of oral TXA to combined topical/IV/oral TXA.
WORKING HYPOTHESIS


We postulated that oral TXA would offer the same efficacy and safety as combined topical/IV/oral regime. We asked: (1) Would blood loss and haemoglobin change be affected? (2) Would complication rates increase?
PATIENTS AND METHODS


Patients were randomised into either the study group (oral TXA regimen) or the control group (combined topical/IV/oral TXA). Both groups were administered three doses of TXA and received the same post-operative venous thromboembolism prophylaxis. Efficacy outcomes including blood loss and haemoglobin (Hb) change were investigated, together with safety outcomes of incidence of deep vein thrombosis and adverse events.
RESULTS


The study (n=25) and control (n=28) group were comparable at baseline (eg pre-op haemoglobin). No significant difference was found between the study and control group in terms of Hb change (32.9±8.9 vs. 31.8±10.4, p=0.687) or blood loss (measured 640.0±291.1 vs. 538.3±270.2, p=0.173 and total 1211.5±336.0 vs. 1092.9±341.4, p=0.214). No cases of DVT were reported for either group and no statistical differences were found in the incidence of adverse events (nausea, hypotension, constipation) between groups.
DISCUSSION


This study has shown for the first time that an oral TXA regimen is non-inferior to a topical/IV/oral regimen in TKA in efficacy and safety. Utilising oral TXA in place of a combined topical/IV/oral regime can significantly reduce costs without compromising patient outcomes.
LEVEL OF EVIDENCE


II, Randomised controlled trial.",2019,"No cases of DVT were reported for either group and no statistical differences were found in the incidence of adverse events (nausea, hypotension, constipation) between groups.
","['Patients', 'total knee arthroplasty']","['oral TXA to combined topical/IV/oral TXA', 'Tranexamic acid (TXA', 'control group (combined topical/IV/oral TXA', 'oral vs. combined topical/intravenous/oral tranexamic acid', 'TXA']","['blood loss', 'blood loss and haemoglobin (Hb) change', 'Hb change', 'adverse events (nausea, hypotension, constipation', 'efficacy and safety', 'DVT', 'blood loss and haemoglobin change', 'safety outcomes of incidence of deep vein thrombosis and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",,0.114837,"No cases of DVT were reported for either group and no statistical differences were found in the incidence of adverse events (nausea, hypotension, constipation) between groups.
","[{'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'King', 'Affiliation': 'Ramsay Pharmacy Services, John Flynn Hospital, Queensland, Australia; School of Pharmacy and Pharmacology, Griffith University, Queensland, Australia; Quality Use of Medicines Network, Griffith University, Queensland, Australia.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Randle', 'Affiliation': 'The Gold Coast Centre for Bone & Joint Surgery, John Flynn Hospital, Queensland, Australia.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Dare', 'Affiliation': 'Ramsay Pharmacy Services, John Flynn Hospital, Queensland, Australia; Quality Use of Medicines Network, Griffith University, Queensland, Australia.'}, {'ForeName': 'Nijole', 'Initials': 'N', 'LastName': 'Bernaitis', 'Affiliation': 'School of Pharmacy and Pharmacology, Griffith University, Queensland, Australia; Quality Use of Medicines Network, Griffith University, Queensland, Australia. Electronic address: n.bernaitis@griffith.edu.au.'}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2019.06.008']
1676,31547949,Evaluation of the efficacy of different treatment modalities for painful temporomandibular disorders.,"The purpose of this study was to clinically evaluate the efficacies of three treatment methods and to compare their outcomes in patients with painful disc displacement. The study group comprised 45 patients with unilateral temporomandibular disorders who fell into Axis I group II (with limited mouth opening) of the Research Diagnostic Criteria for Temporomandibular Disorders. Magnetic resonance imaging was used for definitive diagnosis. The patients were divided randomly into three groups according to the treatment method: splint therapy, splint therapy with ultrasound-guided arthrocentesis, and splint therapy with low-level laser therapy. Patients were followed up after treatment for 6 months. The groups were compared in terms of pain and functional jaw movements (unassisted mouth opening without pain, maximum unassisted mouth opening, and contralateral movements). At the end of treatment, functional jaw movements were significantly increased while pain values were significantly decreased in all groups (P<0.05). Group 2 had a quicker improvement in terms of mouth opening scores at the end of the first month, and unassisted mouth opening without pain was found to be more than 35 millimetres in all groups at the end of 6 months. All treatment modalities showed effective results on pain and functional jaw movements in the treatment of temporomandibular disorders.",2020,"At the end of treatment, functional jaw movements were significantly increased while pain values were significantly decreased in all groups (P<0.05).","['patients with painful disc displacement', 'painful temporomandibular disorders', '45 patients with unilateral temporomandibular disorders who fell into Axis I group II (with limited mouth opening) of the Research Diagnostic Criteria for Temporomandibular Disorders']","['Magnetic resonance imaging', 'splint therapy, splint therapy with ultrasound-guided arthrocentesis, and splint therapy with low-level laser therapy']","['pain values', 'pain and functional jaw movements', 'pain and functional jaw movements (unassisted mouth opening without pain, maximum unassisted mouth opening, and contralateral movements', 'unassisted mouth opening without pain', 'functional jaw movements', 'mouth opening scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0039494', 'cui_str': 'TMJ Diseases'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0204861', 'cui_str': 'Application of splint (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0204854', 'cui_str': 'Arthrocentesis'}, {'cui': 'C0279027', 'cui_str': 'Low-Power Laser Therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",45.0,0.0182591,"At the end of treatment, functional jaw movements were significantly increased while pain values were significantly decreased in all groups (P<0.05).","[{'ForeName': 'Z S', 'Initials': 'ZS', 'LastName': 'Abbasgholizadeh', 'Affiliation': 'Department of Prosthodontics, Faculty of Dentistry, Marmara University, Istanbul, Turkey. Electronic address: zeliha.sanivar@marmara.edu.tr.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Evren', 'Affiliation': 'Department of Prosthodontics, Faculty of Dentistry, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ozkan', 'Affiliation': 'Department of Prosthodontics, Faculty of Dentistry, Marmara University, Istanbul, Turkey.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2019.08.010']
1677,31279647,Angioplasty with versus without routine stent placement for Budd-Chiari syndrome: a randomised controlled trial.,"BACKGROUND


Angioplasty recanalisation is recommended as the first-line interventional procedure for Budd-Chiari syndrome, but subsequent restenosis is common. We aimed to test whether use of routine, non-selective stenting in angioplasty could improve patency and treatment efficacy with adequate safety in Budd-Chiari syndrome.
METHODS


We did a randomised controlled trial, for which patients aged 18-75 years with Budd-Chiari syndrome with membranous obstruction or short-length stenosis (≤4 cm), and a Child-Pugh score of less than 13 were considered eligible. Patients were excluded if they had obstruction not amenable to angioplasty, were recommended to be treated with transjugular intrahepatic portosystemic shunt or liver transplantation, or had contraindications for angioplasty. Eligible patients were randomly assigned (1:1) to an angioplasty-only group or an angioplasty plus routine stenting group, with use of a web-based allocation system (Pocock and Simon's minimisation method, stratified by obstruction features and Child-Pugh score). Recanalisation procedures were done within 24 h of randomisation. The statistician and investigators responsible for data collection data and endpoint assessment were masked to group allocation. The primary outcome was the proportion of patients free of restenosis, analysed in the intention-to-treat population. The study is registered on ClinicalTrials.gov (NCT02201485) and is completed.
FINDINGS


Between July 28, 2014, and Sept 29, 2017, 88 (59%) of 150 screened patients were enrolled and assigned either the angioplasty-only group (n=45) or the angioplasty plus routine stenting group (n=43). During a median follow-up period of 27 months (IQR 19-41), the angioplasty plus routine stenting group had significantly higher proportion of patients free of restenosis (42 [98%] of 43 patients) than did the angioplasty-only group (27 [60%] of 45 patients; p<0·0001). In the survival analysis, 3-year restenosis-free survival was 96·0% (95% CI 88·6-100·0) in the routine stenting group versus 60·4% (46·4-78·7) in the angioplasty-only group (log-rank p<0·0001). The hazard ratio for restenosis was 0·04 (95% CI 0·01-0·31) in favour of routine stenting, with an absolute risk reduction of 35·6% (95% CI 24·2-55·0). Two (5%) patients in the angioplasty plus routine stenting group and one (2%) patient in the angioplasty-only group died during follow-up. One (2%) patient from the angioplasty plus routine stenting group had puncture site haematoma, which was not related to stenting. No stent fracture or migration occurred. Anticoagulation-related adverse events occurred in five (11%) patients from angioplasty alone group and five (12%) patients from angioplasty plus routine stenting group.
INTERPRETATION


Routine stenting with angioplasty is superior to angioplasty alone for preventing restenosis in patients with Budd-Chiari syndrome with short-length stenosis and is safe to use as part of first-line invasive treatment. Further validation is needed in similar settings and other regions in which different characteristics of Budd-Chiari syndrome are more prevalent.
FUNDING


National Natural Science Foundation of China, National Key Technology R&D Programme, Optimised Overall Project of Shaanxi Province, Boost Programme of Xijing Hospital.",2019,"INTERPRETATION


Routine stenting with angioplasty is superior to angioplasty alone for preventing restenosis in patients with Budd-Chiari syndrome with short-length stenosis and is safe to use as part of first-line invasive treatment.","['Between July 28, 2014, and Sept 29, 2017, 88 (59%) of 150 screened patients', 'Patients were excluded if they had obstruction not amenable to angioplasty', 'Budd-Chiari syndrome', 'patients with Budd-Chiari syndrome with short-length stenosis', 'patients aged 18-75 years with Budd-Chiari syndrome with membranous obstruction or short-length stenosis (≤4 cm), and a Child-Pugh score of less than 13 were considered eligible', 'Eligible patients']","['Angioplasty with versus without routine stent placement', 'angioplasty alone', ""angioplasty-only group or an angioplasty plus routine stenting group, with use of a web-based allocation system (Pocock and Simon's minimisation method, stratified by obstruction features and Child"", 'angioplasty plus routine stenting', 'transjugular intrahepatic portosystemic shunt or liver transplantation, or had contraindications for angioplasty']","['hazard ratio for restenosis', 'proportion of patients free of restenosis, analysed in the intention-to-treat population', 'Anticoagulation-related adverse events', 'survival analysis, 3-year restenosis-free survival', 'proportion of patients free of restenosis', 'puncture site haematoma']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C0856761', 'cui_str': ""Chiari's Syndrome""}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0333172', 'cui_str': 'Membranous obstruction (morphologic abnormality)'}, {'cui': 'C2347612', 'cui_str': 'Child-Pugh score (assessment scale)'}]","[{'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0443058', 'cui_str': 'Simon (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1301416', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C1301624', 'cui_str': 'Contraindications'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038953', 'cui_str': 'Survival Analysis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}]",,0.159232,"INTERPRETATION


Routine stenting with angioplasty is superior to angioplasty alone for preventing restenosis in patients with Budd-Chiari syndrome with short-length stenosis and is safe to use as part of first-line invasive treatment.","[{'ForeName': 'Qiuhe', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Chuangye', 'Initials': 'C', 'LastName': 'He', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xulong', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Bohan', 'Initials': 'B', 'LastName': 'Luo', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xingshun', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Wengang', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Bai', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Tianlei', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Jiahao', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Zhengyu', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Han', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Shihao', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Enxing', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Dongdong', 'Initials': 'D', 'LastName': 'Xia', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Zhexuan', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': ""Department of Medical Statistics, School of Preventive Medicine, Fourth Military Medical University, Xi'an, Shaanxi, China; Information Technology Department, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Ultrasound, Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Zhanxin', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Jielai', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': ""Department of Medical Statistics, School of Preventive Medicine, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Daiming', 'Initials': 'D', 'LastName': 'Fan', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Guohong', 'Initials': 'G', 'LastName': 'Han', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China. Electronic address: hangh@fmmu.edu.cn.""}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30177-3']
1678,31366355,Barriers and facilitators to implementing cancer prevention clinical decision support in primary care: a qualitative study.,"BACKGROUND


In the United States, primary care providers (PCPs) routinely balance acute, chronic, and preventive patient care delivery, including cancer prevention and screening, in time-limited visits. Clinical decision support (CDS) may help PCPs prioritize cancer prevention and screening with other patient needs. In a three-arm, pragmatic, clinic-randomized control trial, we are studying cancer prevention CDS in a large, upper Midwestern healthcare system. The web-based, electronic health record (EHR)-linked CDS integrates evidence-based primary and secondary cancer prevention and screening recommendations into an existing cardiovascular risk management CDS system. Our objective with this study was to identify adoption barriers and facilitators before implementation in primary care.
METHODS


We conducted semi-structured interviews guided by the Consolidated Framework for Implementation Research (CFIR) with 28 key informants employed by the healthcare organization in either leadership roles or the direct provision of clinical care. Transcribed interviews were analyzed using qualitative content analysis.
RESULTS


EHR, CDS workflow, CDS users (providers and patients), training, and organizational barriers and facilitators were identified related to Intervention Characteristics, Outer Setting, Inner Setting, and Characteristics of Individuals CFIR domains.
CONCLUSION


Identifying and addressing key informant-identified barriers and facilitators before implementing cancer prevention CDS in primary care may support a successful implementation and sustained use. The CFIR is a useful framework for understanding pre-implementation barriers and facilitators. Based on our findings, the research team developed and instituted specialized training, pilot testing, implementation plans, and post-implementation efforts to maximize identified facilitators and address barriers.
TRIAL REGISTRATION


clinicaltrials.gov , NCT02986230 , December 6, 2016.",2019,"EHR, CDS workflow, CDS users (providers and patients), training, and organizational barriers and facilitators were identified related to Intervention Characteristics, Outer Setting, Inner Setting, and Characteristics of Individuals CFIR domains.
",['primary care'],['Clinical decision support (CDS'],"['EHR, CDS workflow, CDS users (providers and patients), training, and organizational barriers and facilitators']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C4042765', 'cui_str': 'Clinical Decision Support'}]","[{'cui': 'C1710679', 'cui_str': 'Work Flow'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",,0.067567,"EHR, CDS workflow, CDS users (providers and patients), training, and organizational barriers and facilitators were identified related to Intervention Characteristics, Outer Setting, Inner Setting, and Characteristics of Individuals CFIR domains.
","[{'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Harry', 'Affiliation': 'Essentia Institute of Rural Health, 502 East Second Street, Duluth, MN, 55805, USA.'}, {'ForeName': 'Anjali R', 'Initials': 'AR', 'LastName': 'Truitt', 'Affiliation': 'HealthPartners Institute, 3311 E. Old Shakopee Road, Bloomington, MN, 55425, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Saman', 'Affiliation': 'Essentia Institute of Rural Health, 502 East Second Street, Duluth, MN, 55805, USA. Daniel.Saman@EssentiaHealth.org.'}, {'ForeName': 'Hillary A', 'Initials': 'HA', 'LastName': 'Henzler-Buckingham', 'Affiliation': 'Essentia Institute of Rural Health, 502 East Second Street, Duluth, MN, 55805, USA.'}, {'ForeName': 'Clayton I', 'Initials': 'CI', 'LastName': 'Allen', 'Affiliation': 'Essentia Institute of Rural Health, 502 East Second Street, Duluth, MN, 55805, USA.'}, {'ForeName': 'Kayla M', 'Initials': 'KM', 'LastName': 'Walton', 'Affiliation': 'Essentia Institute of Rural Health, 502 East Second Street, Duluth, MN, 55805, USA.'}, {'ForeName': 'Heidi L', 'Initials': 'HL', 'LastName': 'Ekstrom', 'Affiliation': 'HealthPartners Institute, 3311 E. Old Shakopee Road, Bloomington, MN, 55425, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': ""O'Connor"", 'Affiliation': 'HealthPartners Institute, 3311 E. Old Shakopee Road, Bloomington, MN, 55425, USA.'}, {'ForeName': 'JoAnn M', 'Initials': 'JM', 'LastName': 'Sperl-Hillen', 'Affiliation': 'HealthPartners Institute, 3311 E. Old Shakopee Road, Bloomington, MN, 55425, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Bianco', 'Affiliation': 'Essentia Health - Ely Clinic, 300 W Conan Street, Ely, MN, 55731, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Elliott', 'Affiliation': 'HealthPartners Institute, 3311 E. Old Shakopee Road, Bloomington, MN, 55425, USA.'}]",BMC health services research,['10.1186/s12913-019-4326-4']
1679,31233662,Pain vs. comfort diary: A fully remote app-based experiment.,"BACKGROUND


Focusing on pain while completing a pain diary might have detrimental effects on pain intensity. Inverted comfort ratings might be used instead.
METHODS


A fully remote app-based registered experiment was conducted to investigate the effects of a pain versus comfort diary on 7-day recall ratings of pain intensity during a 3-week period. The diary included questions about past, current and expected pain or comfort. Randomization took place by the study app, thereby controlling for effects of experimenter bias.
RESULTS


Contrary to the study hypothesis, multilevel regression showed a more pronounced decrease in 7-day recall ratings of pain in the group who rated pain intensity daily (n = 184) than in the group who rated comfort daily (n = 205, B = -0.17, p = 0.034). There were no between-group differences in secondary outcomes (comfort, depressive symptoms, pain interference and happiness). Exploratory analyses revealed more pronounced decreases in pain intensity in participants who experienced less frequent pain in the previous 6 months. Correlations between pain and comfort ratings decreased from -0.39 at baseline to -0.06 after 3 weeks.
CONCLUSIONS


The findings do not support the potential beneficial effects of replacing diary ratings of pain intensity with diary ratings of comfort. The unexpected decreases among those who completed daily pain diaries might have been due to the inclusion of questions about expected pain. Decreasing correlations between pain and comfort ratings suggest that comfort ratings are not merely inverted pain ratings; rather, they appear to assess a domain distinct from pain intensity.
SIGNIFICANCE


The positive effects of pain diaries on pain trajectories appear to constitute a reliable effect and not a methodological artefact. Pain diaries should be investigated systematically to identify ways to optimize their effects on clinical outcomes. Comfort diaries, however, do not appear to be an efficacious substitute for pain diaries; if the current findings replicate, they indicate that primary care practitioners should continue to use pain diaries in clinical care.",2019,"There were no between-group differences in secondary outcomes (comfort, depressive symptoms, pain interference, and happiness).",['A fully remote app-based registered experiment'],['pain vs. comfort diary'],"['7-day recall ratings of pain', 'secondary outcomes (comfort, depressive symptoms, pain interference, and happiness', 'diary included questions about past, current and expected pain or comfort', 'frequent pain', 'pain and comfort ratings', '7-day recall ratings of pain intensity', 'pain intensity']","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0376660', 'cui_str': 'Diary'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.0768825,"There were no between-group differences in secondary outcomes (comfort, depressive symptoms, pain interference, and happiness).","[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Gruszka', 'Affiliation': 'Faculty of Psychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Stammen', 'Affiliation': 'Faculty of Psychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Nicolai', 'Initials': 'N', 'LastName': 'Bissantz', 'Affiliation': 'Faculty of Mathematics, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Jensen', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, Washington.'}]","European journal of pain (London, England)",['10.1002/ejp.1446']
1680,24671721,Diffusion tensor imaging in extremely low birth weight infants managed with hypercapnic vs. normocapnic ventilation.,"BACKGROUND


Permissive hypercapnia is a ventilatory strategy used to prevent lung injury in ventilated extremely low birth weight (ELBW, birth weight ≤1,000 g) infants. However, there is retrospective evidence showing that high CO2 is associated with brain injury.
OBJECTIVE


The objective of this study was to compare brain white matter development at term-equivalent age in ELBW infants randomized to hypercapnic vs. normocapnic ventilation during the first week of life and in healthy non-ventilated term newborns.
MATERIALS AND METHODS


Twenty-two ELBW infants from a randomized controlled trial were included in this study; 11 received hypercapnic (transcutaneous PCO2 [tcPCO2] 50-60 mmHg) ventilation and 11 normocapnic (tcPCO2 35-45 mmHg) ventilation during the first week of life while still intubated. In addition, ten term healthy newborns served as controls. Magnetic resonance imaging (MRI) with diffusion tensor imaging (DTI) was performed at term-equivalent age for the ELBW infants and at approximately 2 weeks of age for the control infants. White matter injury on conventional MRI was graded in the ELBW and control infants using a scoring system adopted from literature. Tract-based spatial statistics (TBSS) was used to evaluate for differences in DTI measured fractional anisotropy (FA, spatially normalized to a customized template) among the ELBW and term control infants.
RESULTS


Conventional MRI white matter scores were not different (7.3 ± 1.7 vs. 6.9 ± 1.4, P = 0.65) between the hypercapnic and normocapnic ELBW infants. TBSS analysis did not show significant differences (P < 0.05, corrected) between the two ELBW infant groups, although before multiple comparisons correction, hypercapnic infants had many regions with lower FA and no regions with higher FA (P < 0.05, uncorrected) compared to normocapnic infants. When compared to the control infants, normocapnic ELBW infants had a few small regions with significantly lower FA, while hypercapnic ELBW infants had more widespread regions with significantly lower FA (P < 0.05, fully corrected for multiple comparisons).
CONCLUSIONS


Normocapnic ventilation vs. permissive hypercapnia may be associated with improved white matter development at term-equivalent age in ELBW infants. This effect, however, was small and was not apparent on conventional MRI. Further research is needed using larger sample sizes to assess if permissive hypercapnic ventilation in ELBW infants is associated with worse white matter development.",2014,"TBSS analysis did not show significant differences (P < 0.05, corrected) between the two ELBW infant groups, although before multiple comparisons correction, hypercapnic infants had many regions with lower FA and no regions with higher FA (P < 0.05, uncorrected) compared to normocapnic infants.","['Twenty-two ELBW infants from a randomized controlled trial were included in this study; 11 received', 'lung injury in ventilated extremely low birth weight (ELBW, birth weight ≤1,000 g) infants', 'extremely low birth weight infants managed with hypercapnic vs. normocapnic ventilation', 'healthy non-ventilated term newborns']","['hypercapnic vs. normocapnic ventilation', 'Magnetic resonance imaging (MRI) with diffusion tensor imaging (DTI', 'hypercapnic (transcutaneous PCO2 [tcPCO2] 50-60 mmHg) ventilation and 11 normocapnic (tcPCO2 35-45 mmHg) ventilation']","['Conventional MRI white matter scores', 'FA', 'Tract-based spatial statistics (TBSS']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0273115', 'cui_str': 'Pulmonary Injury'}, {'cui': 'C0456065', 'cui_str': 'Infant, Extremely Low Birth Weight'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0391839', 'cui_str': 'PCO2'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C1318131', 'cui_str': 'TcPCO2'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0682708'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}]",22.0,0.113433,"TBSS analysis did not show significant differences (P < 0.05, corrected) between the two ELBW infant groups, although before multiple comparisons correction, hypercapnic infants had many regions with lower FA and no regions with higher FA (P < 0.05, uncorrected) compared to normocapnic infants.","[{'ForeName': 'Xiawei', 'Initials': 'X', 'LastName': 'Ou', 'Affiliation': 'Department of Radiology, University of Arkansas for Medical Sciences, Little Rock, AR, USA, ouxiawei@uams.edu.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Glasier', 'Affiliation': ''}, {'ForeName': 'Raghu H', 'Initials': 'RH', 'LastName': 'Ramakrishnaiah', 'Affiliation': ''}, {'ForeName': 'Teresita L', 'Initials': 'TL', 'LastName': 'Angtuaco', 'Affiliation': ''}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Mulkey', 'Affiliation': ''}, {'ForeName': 'Zhaohua', 'Initials': 'Z', 'LastName': 'Ding', 'Affiliation': ''}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Kaiser', 'Affiliation': ''}]",Pediatric radiology,['10.1007/s00247-014-2946-8']
1681,25331625,"A new reversible and potent P2Y12 receptor antagonist (ACT-246475): tolerability, pharmacokinetics, and pharmacodynamics in a first-in-man trial.","BACKGROUND AND OBJECTIVES


ACT-246475 is a new reversible, selective, and potent antagonist of the platelet P2Y12 receptor. This study was a first-in-man trial investigating the tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of ACT-246475 and its di-ester prodrug (ACT-281959) in healthy males.
METHODS


The study had a double-blind, randomized, ascending single-dose design with an oral formulation F1 (i.e., ACT-281959 or placebo) (Part I) and an open-label, randomized, 3-period, crossover design comparing exploratory formulations of ACT-281959 (F2) 70 mg and ACT-246475 (dF) 50 mg to F1 70 mg (Part II). In Part I, doses up to 1,000 mg were tested in 40 healthy subjects. Nine healthy subjects were enrolled in Part II. Standard safety parameters, inhibition of platelet aggregation, and ACT-246475 plasma concentrations were measured. Non-compartmental pharmacokinetic analysis was performed.
RESULTS


All doses and formulations were well tolerated. The most frequent adverse event was headache, whereas no events of bleeding or dyspnea were reported. In Part I, ACT-246475 area under the plasma concentration-time curve (AUC) increased dose-proportionally whereas maximum plasma concentration (C max) was less than dose-proportional. The highest C max [geometric mean (95 % CI)] at 1,000 mg was 13.8 (9.7, 19.5) pmol/mL at 4.5 h post-dose, terminal half-life (t ½) was ~10 h. ACT-246475 C max and AUC0-∞ ratios of geometric means (90 % CI) using F1 as reference, for F2 were 8.5 (5.42, 13.35) and 3.4 (2.40, 4.82), respectively, and for dF 2.2 (1.42, 3.49) and 1.5 (1.07, 2.16), respectively. Mean peak platelet inhibition was 31.0 % after F1 (1,000 mg) and 47.8 % after F2.
CONCLUSIONS


Oral doses of ACT-281959 and ACT-246475 were well tolerated. Platelet inhibition correlated with ACT-246475 exposure. Exploratory formulations enhanced the bioavailability and antiplatelet effect of ACT-246475.",2014,"Standard safety parameters, inhibition of platelet aggregation, and ACT-246475 plasma concentrations were measured. Non-compartmental pharmacokinetic analysis was performed.
","['40 healthy subjects', 'healthy males', 'Nine healthy subjects were enrolled in Part II']","['ACT-246475 and its di-ester prodrug (ACT-281959', 'oral formulation F1 (i.e., ACT-281959 or placebo) ', 'ACT-246475', 'ACT-281959 (F2) 70\xa0mg and ACT-246475 (dF']","['plasma concentration-time curve (AUC', 'Mean peak platelet inhibition', 'bleeding or dyspnea', 'Standard safety parameters, inhibition of platelet aggregation, and ACT-246475 plasma concentrations', 'tolerated', 'highest C max [geometric mean', 'Platelet inhibition', 'maximum plasma concentration (C max', 'bioavailability and antiplatelet effect', 'h. ACT-246475 C max and AUC0-∞ ratios of geometric means', 'tolerability, pharmacokinetics, and pharmacodynamics']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C4079264', 'cui_str': 'ACT-246475'}, {'cui': 'C0014898', 'cui_str': 'Esters'}, {'cui': 'C0033262', 'cui_str': 'Drug Precursors'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0677599', 'cui_str': 'Platelet aggregation'}, {'cui': 'C4079264', 'cui_str': 'ACT-246475'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]",40.0,0.128259,"Standard safety parameters, inhibition of platelet aggregation, and ACT-246475 plasma concentrations were measured. Non-compartmental pharmacokinetic analysis was performed.
","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Baldoni', 'Affiliation': 'Department of Clinical Pharmacology, Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, 4123, Allschwil, Switzerland, daniela.baldoni@actelion.com.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Bruderer', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Krause', 'Affiliation': ''}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Gutierrez', 'Affiliation': ''}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Gueret', 'Affiliation': ''}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Astruc', 'Affiliation': ''}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': ''}]",Clinical drug investigation,['10.1007/s40261-014-0236-8']
1682,25407559,A Phase III study of radiation therapy (RT) and O⁶-benzylguanine + BCNU versus RT and BCNU alone and methylation status in newly diagnosed glioblastoma and gliosarcoma: Southwest Oncology Group (SWOG) study S0001.,"AIMS


To determine the efficacy of methylguanine methyltransferase (MGMT) depletion + BCNU [1,3-bis(2-chloroethyl)-1- nitrosourea: carmustine] therapy and the impact of methylation status in adults with glioblastoma multiforme (GBM) and gliosarcoma.
METHODS


Methylation analysis was performed on GBM patients with adequate tissue samples. Patients with newly diagnosed GBM or gliosarcoma were eligible for this Phase III open-label clinical trial. At registration, patients were randomized to Arm 1, which consisted of therapy with O(6)-benzylguanine (O(6)-BG) + BCNU 40 mg/m(2) (reduced dose) + radiation therapy (RT) (O6BG + BCNU arm), or Arm 2, which consisted of therapy with BCNU 200 mg/m(2) + RT (BCNU arm).
RESULTS


A total of 183 patients with newly diagnosed GBM or gliosarcoma from 42 U.S. institutions were enrolled in this study. Of these, 90 eligible patients received O(6)-BG + BCNU + RT and 89 received BCNU + RT. The trial was halted at the first interim analysis in accordance with the guidelines for stopping the study due to futility (<40 % improvement among patients on the O6BG + BCNU arm). Following adjustment for stratification factors, there was no significant difference in overall survival (OS) or progression-free survival (PFS) between the two groups (one sided p = 0.94 and p = 0.88, respectively). Median OS was 11 [95 % confidence interval (CI) 8-13] months for patients in the O6BG + BCNU arm and 10 (95 % CI 8-12) months for those in the BCNU arm. PFS was 4 months for patients in each arm. Adverse events were reported in both arms, with significantly more grade 4 and 5 events in the experimental arm.
CONCLUSIONS


The addition of O(6)-BG to the standard regimen of radiation and BCNU for the treatment patients with newly diagnosed GBM and gliosarcoma did not provide added benefit and in fact caused additional toxicity.",2015,"Following adjustment for stratification factors, there was no significant difference in overall survival (OS) or progression-free survival (PFS) between the two groups (one sided p = 0.94 and p = 0.88, respectively).","['GBM patients with adequate tissue samples', 'newly diagnosed glioblastoma and gliosarcoma', '90 eligible patients received', 'Patients with newly diagnosed GBM or gliosarcoma were eligible for this Phase III open-label clinical trial', '183 patients with newly diagnosed GBM or gliosarcoma from 42 U.S. institutions', 'adults with glioblastoma multiforme (GBM) and gliosarcoma']","['methylguanine methyltransferase (MGMT) depletion + BCNU', 'O(6)-benzylguanine (O(6)-BG) + BCNU 40 mg/m(2) (reduced dose) + radiation therapy (RT) (O6BG + BCNU arm), or Arm 2, which consisted of therapy with BCNU 200 mg/m(2) + RT (BCNU arm', '1,3-bis(2-chloroethyl)-1- nitrosourea', 'O(6)-BG + BCNU + RT', 'BCNU + RT', 'O(6)-BG', 'carmustine', 'radiation therapy (RT) and O⁶-benzylguanine + BCNU versus RT and BCNU']","['Median OS', 'overall survival (OS) or progression-free survival (PFS', 'PFS', 'Adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0206726', 'cui_str': 'Sarcomatous Glioma'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1621958', 'cui_str': 'Glioblastoma Multiforme'}]","[{'cui': 'C4521687', 'cui_str': 'Methyltransferase (disposition)'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C0007257', 'cui_str': 'Carmustine'}, {'cui': 'C0083812', 'cui_str': 'O6-benzylguanine'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",183.0,0.0676329,"Following adjustment for stratification factors, there was no significant difference in overall survival (OS) or progression-free survival (PFS) between the two groups (one sided p = 0.94 and p = 0.88, respectively).","[{'ForeName': 'Deborah T', 'Initials': 'DT', 'LastName': 'Blumenthal', 'Affiliation': 'Neuro-oncology Service, Department of Oncology, Tel-Aviv Sourasky Medical Center-Tel-Aviv University, 6 Weizmann Street, 64239, Tel Aviv, Israel, deborahblumenthal@gmail.com.'}, {'ForeName': 'Cathryn', 'Initials': 'C', 'LastName': 'Rankin', 'Affiliation': ''}, {'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Stelzer', 'Affiliation': ''}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Spence', 'Affiliation': ''}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Sloan', 'Affiliation': ''}, {'ForeName': 'Dennis F', 'Initials': 'DF', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Gilbert D A', 'Initials': 'GD', 'LastName': 'Padula', 'Affiliation': ''}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Schulman', 'Affiliation': ''}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Wade', 'Affiliation': ''}, {'ForeName': 'Elisabeth J', 'Initials': 'EJ', 'LastName': 'Rushing', 'Affiliation': ''}]",International journal of clinical oncology,['10.1007/s10147-014-0769-0']
1683,30230349,Reply to Fitzmaurice  et al. : The LIBERATE Trial: Options to Reduce the Risk of Post-procedural Pneumothorax and Length of Stay.,,2018,,[],[],[],[],[],[],,0.0308043,,"[{'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Lewis Katz School of Medicine at Temple UniversityPhiladelphia, Pennsylvania.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Sue', 'Affiliation': ""St. Joseph's Hospital and Medical CenterPhoenix, Arizona.""}, {'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Sciurba', 'Affiliation': 'University of PittsburghPittsburgh, Pennsylvaniaand.'}, {'ForeName': 'Dirk-Jan', 'Initials': 'DJ', 'LastName': 'Slebos', 'Affiliation': 'University Medical Center GroningenGroningen, the Netherlands.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201808-1477LE']
1684,25623785,Endotracheal Intubation in Patients Treated for Prehospital Status Epilepticus.,"INTRODUCTION


Limited data describe the frequency, timing, or indications for endotracheal intubation (ETI) in patients with status epilepticus. A better understanding of the characteristics of patients with status epilepticus requiring airway interventions could inform clinical care. We sought to characterize ETI use in patients with prehospital status epilepticus.
METHODS


This study was a secondary analysis of the Rapid Anticonvulsant Medication Prior to Arrival Trial, a multi-center, randomized trial comparing intravenous lorazepam to intramuscular midazolam for prehospital status epilepticus treatment. Subjects received ETI in the prehospital, Emergency Department (ED), or inpatient setting at the discretion of caregivers.
RESULTS


Of 1023 enrollments, 218 (21 %) received ETI. 204 (93.6 %) of the ETIs were performed in the hospital and 14 (6.4 %) in the prehospital setting. Intubated patients were older (52 vs 41 years, p < 0.001), and men underwent ETI more than women (26 vs 21 %, p = 0.047). Patients with ongoing seizures on ED arrival had a higher rate of ETI (32 vs 16 %, p < 0.001), as did those who received rescue anti-seizure medication (29 vs 20 %, p = 0.004). Mortality was higher for intubated patients (7 vs 0.4 %, p < 0.001). Most ETI (n = 133, 62 %) occurred early (prior to or within 30 min after ED arrival), and late ETI was associated with higher mortality (14 vs 3 %, p = 0.002) than early ETI.
CONCLUSIONS


ETI is common in patients with status epilepticus, particularly among the elderly or those with refractory seizures. Any ETI and late ETI are both associated with higher mortality.",2015,"Mortality was higher for intubated patients (7 vs 0.4 %, p < 0.001).","['patients with prehospital status epilepticus', 'Patients Treated for Prehospital Status Epilepticus', 'patients with status epilepticus', 'prehospital status epilepticus treatment', 'patients with status epilepticus, particularly among the elderly or those with refractory seizures', 'patients with status epilepticus requiring airway interventions']","['midazolam', 'lorazepam', 'Endotracheal Intubation', 'endotracheal intubation (ETI']","['Mortality', 'rate of ETI', 'higher mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038220', 'cui_str': 'Status Epilepticus, Generalized'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.0877156,"Mortality was higher for intubated patients (7 vs 0.4 %, p < 0.001).","[{'ForeName': 'Taher T', 'Initials': 'TT', 'LastName': 'Vohra', 'Affiliation': 'Department of Emergency Medicine, Henry Ford Hospital, CFP 259, 2799\xa0W Grand Blvd, Detroit, MI, 48202, USA, tvohra1@hfhs.org.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'Katherine S', 'Initials': 'KS', 'LastName': 'Nicholas', 'Affiliation': ''}, {'ForeName': 'Panayiotis N', 'Initials': 'PN', 'LastName': 'Varelas', 'Affiliation': ''}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Harsh', 'Affiliation': ''}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Durkalski', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Silbergleit', 'Affiliation': ''}, {'ForeName': 'Henry E', 'Initials': 'HE', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurocritical care,['10.1007/s12028-014-0106-5']
1685,32000724,Treatment intensification with hepatic arterial infusion chemotherapy in patients with liver-only colorectal metastases still unresectable after systemic induction chemotherapy - a randomized phase II study -- SULTAN UCGI 30/PRODIGE 53 (NCT03164655)- study protocol.,"BACKGROUND


Approximately 40% of colorectal cancer patients will develop colorectal liver metastases (CRLM). The most effective approach to increase long-term survival is CRLM complete resection. Unfortunately, only 10-15% of CRLM are initially considered resectable. The objective response rates (ORR) after current first-line systemic chemotherapy (sys-CT) regimens range from 40 to 80% and complete resection rates (CRR) range from 25 to 50% in patients with initially unresectable CRLM. When CRLM patients are not amenable to complete resection after induction of sys-CT, ORRs obtained with second-line sys-CT are much lower (between 10 and 30%) and consequently CRRs are also low (< 10%). Hepatic arterial infusion (HAI) oxaliplatin may represent a salvage therapy in patients with CRLM unresectable after one or more sys-CT regimens with ORRs and CRRs up to 60 and 30%, respectively. This study is designed to evaluate the efficacy of an intensification strategy based on HAI oxaliplatin combined with sys-CT as a salvage treatment in patients with CRLM unresectable after at least 2 months of first-line induction sys-CT.
OBJECTIVES AND ENDPOINTS OF THE PHASE II STUDY


Our main objective is to investigate the efficacy, in term of CRR (R0-R1), of treatment intensification in patients with liver-only CRLM not amenable to curative-intent resection (and/or ablation) after at least 2 months of induction sys-CT. Patients will receive either HAI oxaliplatin plus systemic FOLFIRI plus targeted therapy (i.e. anti-EGFR antibody or bevacizumab) or conventional sys-CT plus targeted therapy (i.e. anti-EGFR or antiangiogenic antibody). Secondary objectives are to compare: progression-free survival, overall survival, objective response rate, depth of response, feasibility of delivering HAI oxaliplatin including HAI catheter-related complications, and toxicity (NCI-CTCAE v4.0).
METHODS


This study is a multicenter, randomized, comparative phase II trial (power, 80%; two-sided alpha-risk, 5%). Patients will be randomly assigned in a 1:1 ratio to receive HAI oxaliplatin combined with systemic FOLFIRI plus targeted therapy (experimental arm) or the best sys-CT plus targeted therapy on the basis of their first-line prior sys-CT history and current guidelines (control arm). One hundred forty patients are required to account for non-evaluable patients.
TRIAL REGISTRATION


ClinicalTrials.gov, (NCT03164655). Trial registration date: 11th May 2017.",2020,"Our main objective is to investigate the efficacy, in term of CRR (R0-R1), of treatment intensification in patients with liver-only CRLM not amenable to curative-intent resection (and/or ablation) after at least 2 months of induction sys-CT.","['One hundred forty patients are required to account for non-evaluable patients', 'patients with CRLM unresectable after at least 2 months of first-line induction sys-CT', 'colorectal cancer patients will develop colorectal liver metastases (CRLM', 'patients with liver-only colorectal metastases still unresectable after systemic induction chemotherapy - a randomized phase II study -- SULTAN UCGI 30/PRODIGE 53 (NCT03164655)- study protocol', 'patients with liver-only CRLM not amenable to curative-intent resection (and/or ablation) after at least 2 months of induction sys-CT', 'patients with CRLM unresectable after one or more sys-CT regimens with ORRs and CRRs up to 60 and 30%, respectively']","['HAI oxaliplatin combined with sys-CT', 'current first-line systemic chemotherapy (sys-CT', 'hepatic arterial infusion chemotherapy', 'HAI oxaliplatin combined with systemic FOLFIRI plus targeted therapy (experimental arm) or the best sys-CT plus targeted therapy on the basis of their first-line prior sys-CT history and current guidelines (control arm', 'HAI oxaliplatin plus systemic FOLFIRI plus targeted therapy (i.e. anti-EGFR antibody or bevacizumab) or conventional sys-CT plus targeted therapy (i.e. anti-EGFR or antiangiogenic antibody', 'Hepatic arterial infusion (HAI) oxaliplatin']","['complete resection rates (CRR) range', 'objective response rates (ORR', 'progression-free survival, overall survival, objective response rate, depth of response, feasibility of delivering HAI oxaliplatin including HAI catheter-related complications, and toxicity (NCI-CTCAE v4.0']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0647895', 'cui_str': 'Sultan'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4304118', 'cui_str': 'Hepatic arterial infusion chemotherapy (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}]",,0.0542615,"Our main objective is to investigate the efficacy, in term of CRR (R0-R1), of treatment intensification in patients with liver-only CRLM not amenable to curative-intent resection (and/or ablation) after at least 2 months of induction sys-CT.","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Boilève', 'Affiliation': 'Department of Medical Oncology, Gustave Roussy, 114 rue Edouard Vaillant, 94805, Villejuif Cedex, France. alice.boileve@gmail.com.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Maillard', 'Affiliation': 'Department of statistics and epidemiology, Villejuif, France.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Wagner', 'Affiliation': 'Department of radiology, CHU Pitié Salpétrière, Paris, France.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Dromain', 'Affiliation': 'Department of radiology, Centre Hospitalier et Universitaire Vaudois, Lausanne, Switzerland.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Laurent', 'Affiliation': 'Department of hepatogastroenterology, Hôpital Haut Levêque, Pessac, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Dupont Bierre', 'Affiliation': 'Department of digestive surgery, CHP Saint Grégoire, Saint-Grégoire, France.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Le Sourd', 'Affiliation': 'Department of medical oncology, Centre Eugène-Marquis, Rennes, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Audemar', 'Affiliation': 'Department of hepatogastroenterology, Centre hospitalier Côte Basque, Bayonne, France.'}, {'ForeName': 'Ayhan', 'Initials': 'A', 'LastName': 'Ulusakarya', 'Affiliation': 'Department of medical oncology, Hôpital Paul Brousse, Villejuif, France.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Guerin-Meyer', 'Affiliation': ""Department of medical oncology, Institut de Cancerologie de l'Ouest, Angers, France.""}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Smisth', 'Affiliation': 'Department of hepatogastroenterology, Hôpital Haut Levêque, Pessac, France.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Pezzella', 'Affiliation': 'R&D Unicancer, Paris, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'De Baere', 'Affiliation': 'Department of interventional radiology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Goere', 'Affiliation': 'Department of Surgical Oncology, Hôpital Saint Louis, Paris, France.'}, {'ForeName': 'Maximiliano', 'Initials': 'M', 'LastName': 'Gelli', 'Affiliation': 'Department of Surgical Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Taieb', 'Affiliation': 'Department of digestive oncology, Hôpital Européen Georges-Pompidou, Sorbonne Paris Cite/Paris Descartes University, Paris, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Boige', 'Affiliation': 'Department of Medical Oncology, Gustave Roussy, 114 rue Edouard Vaillant, 94805, Villejuif Cedex, France.'}]",BMC cancer,['10.1186/s12885-020-6571-7']
1686,31800542,Randomized Clinical Trial: Crofelemer Treatment in Women With Diarrhea-Predominant Irritable Bowel Syndrome.,"INTRODUCTION


Crofelemer, the active compound purified from latex of Croton lechleri, has been shown to improve HIV and traveler's diarrhea and improve pain in women with irritable bowel syndrome-diarrhea (IBS-D). This trial evaluated the effect of crofelemer on abdominal pain in women with IBS-D.
METHODS


Women with IBS-D were randomized to crofelemer (125 mg) or placebo twice daily for 12 weeks. The primary efficacy endpoint was overall change in percentage of abdominal pain/discomfort-free days. Post hoc analysis for Food and Drug Administration (FDA) monthly responders was performed for stool consistency, abdominal pain, and combined stool consistency and abdominal pain.
RESULTS


A total of 240 women were enrolled. There was no significant difference in overall percentage of pain/discomfort-free day between the groups. In post hoc analysis, FDA abdominal pain monthly responders were significantly more likely during months 1 through 2 (58.3% vs 45.0%, P = 0.030) as well as during the entire 3 months (54.2% vs 42.5%, P = 0.037) in the crofelemer group when compared with placebo. However, there was no significant difference in the percentage of FDA stool consistency monthly responders or combined stool consistency and pain monthly responders between the groups. Crofelemer had a safety profile similar to placebo.
DISCUSSION


Crofelemer did not significantly improve abdominal pain over placebo by the primary endpoint. However, it did based on the FDA abdominal pain monthly responder endpoint. This suggests that crofelemer may have a role in the treatment of abdominal pain associated with IBS-D. Further studies are warranted to evaluate the potential of crofelemer as a visceral analgesic.",2019,There was no significant difference in overall percentage of pain/discomfort-free day between the groups.,"['women with IBS-D', 'Women With Diarrhea-Predominant Irritable Bowel Syndrome', 'women with irritable bowel syndrome-diarrhea (IBS-D', 'A total of 240 women were enrolled', 'Women with IBS-D']",['placebo'],"['stool consistency, abdominal pain, and combined stool consistency and abdominal pain', 'percentage of FDA stool consistency monthly responders or combined stool consistency and pain monthly responders', 'percentage of abdominal pain/discomfort-free days', 'overall percentage of pain/discomfort', 'FDA abdominal pain monthly responders', 'abdominal pain']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1262211', 'cui_str': 'Diarrhoea predominant irritable bowel syndrome'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",240.0,0.256371,There was no significant difference in overall percentage of pain/discomfort-free day between the groups.,"[{'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Nee', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Salley', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Ludwig', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Sommers', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Ballou', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Eve', 'Initials': 'E', 'LastName': 'Takazawa', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Duehren', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Singh', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Iturrino', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Katon', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Ha-Neul', 'Initials': 'HN', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Rangan', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Lembo', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000110']
1687,24986113,"When using patient-reported outcomes in clinical practice, the measure matters: a randomized controlled trial.","BACKGROUND


Patient-reported outcome (PRO) measures are increasingly being used in clinical practice to inform individual patient management, but evidence is needed on which PROs are best suited for clinical use.
METHODS


This controlled trial randomly assigned patients with breast and prostate cancer undergoing treatment to complete one of three PRO measures: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30), Supportive Care Needs Survey-Short Form (SCNS-SF34), or six domains from the Patient-Reported Outcomes Measurement Information System (PROMIS). Patients completed the PRO measures before clinic visits, and the results were provided to both the patient and clinician. At treatment completion, patients and clinicians completed brief feedback forms on the intervention's usefulness and value. Exit interviews were conducted with patients (at end of treatment) and clinicians (at end of study). The primary outcome was the proportion of patients in each arm who either strongly agreed or agreed to all feedback form items.
RESULTS


Of 294 eligible patients invited to participate, 224 (76%) enrolled (median age 66 years, 78% white, 72% prostate). Of the 181 patients (81%) who completed at least one feedback form item, participants in the QLQ-C30 study arm were most likely to strongly agree/agree to all items (74%) followed by PROMIS (61%) and SCNS-SF34 (52%; P = .03). Of the 116 participants (52%) who completed all feedback form items, the results were similar: 82% for the QLQ-C30, 62% for PROMIS, and 56% for SCNS-SF34 (P = .05). Clinicians did not prefer one questionnaire over the others.
CONCLUSION


These results suggest that, when using PROs in clinical practice for patient management, the measure matters in terms of usefulness to patients.",2014,"Of the 116 participants (52%) who completed all feedback form items, the results were similar: 82% for the QLQ-C30, 62% for PROMIS, and 56% for SCNS-SF34 (P = .05).","['patients with breast and prostate cancer undergoing treatment to complete one of three PRO measures: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30', '294 eligible patients invited to participate, 224 (76%) enrolled (median age 66 years, 78% white, 72% prostate']",[],['proportion of patients in each arm who either strongly agreed or agreed to all feedback form items'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0376315', 'cui_str': 'Form'}]",294.0,0.0797288,"Of the 116 participants (52%) who completed all feedback form items, the results were similar: 82% for the QLQ-C30, 62% for PROMIS, and 56% for SCNS-SF34 (P = .05).","[{'ForeName': 'Claire F', 'Initials': 'CF', 'LastName': 'Snyder', 'Affiliation': 'Johns Hopkins School of Medicine; Johns Hopkins Bloomberg School of Public Health; and Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD csnyder@jhsph.edu.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Herman', 'Affiliation': 'Johns Hopkins School of Medicine; Johns Hopkins Bloomberg School of Public Health; and Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'White', 'Affiliation': 'Johns Hopkins School of Medicine; Johns Hopkins Bloomberg School of Public Health; and Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.'}, {'ForeName': 'Brandon S', 'Initials': 'BS', 'LastName': 'Luber', 'Affiliation': 'Johns Hopkins School of Medicine; Johns Hopkins Bloomberg School of Public Health; and Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Blackford', 'Affiliation': 'Johns Hopkins School of Medicine; Johns Hopkins Bloomberg School of Public Health; and Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Carducci', 'Affiliation': 'Johns Hopkins School of Medicine; Johns Hopkins Bloomberg School of Public Health; and Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.'}, {'ForeName': 'Albert W', 'Initials': 'AW', 'LastName': 'Wu', 'Affiliation': 'Johns Hopkins School of Medicine; Johns Hopkins Bloomberg School of Public Health; and Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.'}]",Journal of oncology practice,['10.1200/JOP.2014.001413']
1688,22945782,Nephroprotective role of salacia chinensis in diabetic CKD patients: a pilot study.,"BACKGROUND


Present study aimed to study effect of Salacia Chinensis, a herbal drug, on stabilization of renal functions, and markers of endothelial dysfunction in diabetic chronic kidney disease (CKD) patients.
MATERIALS AND METHODS


30 stable diabetic CKD patients were randomized into 2 groups; group A and B of 15 patients each. Group A was given trial drug Salacia chinensis 1000 mg twice-daily while group B received placebo. Measures of renal function: Serum creatinine and creatinine clearance; markers of endothelial dysfunction: Interleukin-6 and serum Homocysteine, and lipid profile were measured at baseline and during follow-up period of 6 months.
RESULTS


There was stabilization of renal function as measured by serum creatinine and creatinine clearance in patients who received Salacia Chinensis compared to placebo (P value < 0.05), suggesting that Salacia chinensis may retard the progression of chronic kidney disease. Similarly, there was significant decline in both serum homocysteine and IL-6 levels. [P value < 0.05 for both].
CONCLUSION


This pilot study showed a promising role for Salacia chinensis as a renoprotective drug, but further prospective studies involving large number of patients are needed to confirm this and also to delineate possible mechanisms.",2010,"There was stabilization of renal function as measured by serum creatinine and creatinine clearance in patients who received Salacia Chinensis compared to placebo (P value < 0.05), suggesting that Salacia chinensis may retard the progression of chronic kidney disease.","['30 stable diabetic CKD patients', 'diabetic CKD patients', 'diabetic chronic kidney disease (CKD) patients']",['placebo'],"['stabilization of renal function', 'serum creatinine and creatinine clearance', 'renal function: Serum creatinine and creatinine clearance; markers of endothelial dysfunction: Interleukin-6 and serum Homocysteine, and lipid profile', 'serum homocysteine and IL-6 levels']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019878', 'cui_str': '2-amino-4-mercaptobutyric acid'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",30.0,0.0324738,"There was stabilization of renal function as measured by serum creatinine and creatinine clearance in patients who received Salacia Chinensis compared to placebo (P value < 0.05), suggesting that Salacia chinensis may retard the progression of chronic kidney disease.","[{'ForeName': 'Rana G', 'Initials': 'RG', 'LastName': 'Singh', 'Affiliation': 'Department of Nephrology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Surendra S', 'Initials': 'SS', 'LastName': 'Rathore', 'Affiliation': ''}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Aruna', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': ''}, {'ForeName': 'Govind P', 'Initials': 'GP', 'LastName': 'Dubey', 'Affiliation': ''}]",Indian journal of medical sciences,['10.4103/0019-5359.100341']
1689,23937346,RCT of web-based personalized normative feedback for college drinking prevention: are typical student norms good enough?,"OBJECTIVES


Personalized normative feedback (PNF) interventions are generally effective at correcting normative misperceptions and reducing risky alcohol consumption among college students. However, research has yet to establish what level of reference group specificity is most efficacious in delivering PNF. This study compared the efficacy of a web-based PNF intervention using 8 increasingly specific reference groups against a Web-BASICS intervention and a repeated-assessment control in reducing risky drinking and associated consequences.
METHOD


Participants were 1,663 heavy-drinking Caucasian and Asian undergraduates at 2 universities. The referent for web-based PNF was either the typical same-campus student or a same-campus student at 1 (either gender, race, or Greek affiliation), or a combination of 2 (e.g., gender and race), or all 3 levels of specificity (i.e., gender, race, and Greek affiliation). Hypotheses were tested using quasi-Poisson generalized linear models fit by generalized estimating equations.
RESULTS


The PNF intervention participants showed modest reductions in all 4 outcomes (average total drinks, peak drinking, drinking days, and drinking consequences) compared with control participants. No significant differences in drinking outcomes were found between the PNF group as a whole and the Web-BASICS group. Among the 8 PNF conditions, participants receiving typical student PNF demonstrated greater reductions in all 4 outcomes compared with those receiving PNF for more specific reference groups. Perceived drinking norms and discrepancies between individual behavior and actual norms mediated the efficacy of the intervention.
CONCLUSIONS


Findings suggest a web-based PNF intervention using the typical student referent offers a parsimonious approach to reducing problematic alcohol use outcomes among college students.",2013,No significant differences in drinking outcomes were found between the PNF group as a whole and the Web-BASICS group.,"['college drinking prevention', 'Participants were 1,663 heavy-drinking Caucasian and Asian undergraduates at 2 universities', 'college students']","['Personalized normative feedback (PNF) interventions', 'PNF intervention', 'web-based PNF intervention', 'RCT of web-based personalized normative feedback', 'PNF']","['risky alcohol consumption', 'drinking outcomes', '4 outcomes (average total drinks, peak drinking, drinking days, and drinking consequences']","[{'cui': 'C4042862', 'cui_str': 'University Student Drinking'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",1663.0,0.041086,No significant differences in drinking outcomes were found between the PNF group as a whole and the Web-BASICS group.,"[{'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Labrie', 'Affiliation': 'Department of Psychology, Loyola Marymount University.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Atkins', 'Affiliation': ''}, {'ForeName': 'Clayton', 'Initials': 'C', 'LastName': 'Neighbors', 'Affiliation': ''}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'Shannon R', 'Initials': 'SR', 'LastName': 'Kenney', 'Affiliation': ''}, {'ForeName': 'Lucy E', 'Initials': 'LE', 'LastName': 'Napper', 'Affiliation': ''}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Walter', 'Affiliation': ''}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Kilmer', 'Affiliation': ''}, {'ForeName': 'Justin F', 'Initials': 'JF', 'LastName': 'Hummer', 'Affiliation': ''}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Grossbard', 'Affiliation': ''}, {'ForeName': 'Tehniat M', 'Initials': 'TM', 'LastName': 'Ghaidarov', 'Affiliation': ''}, {'ForeName': 'Sruti', 'Initials': 'S', 'LastName': 'Desai', 'Affiliation': ''}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Larimer', 'Affiliation': ''}]",Journal of consulting and clinical psychology,['10.1037/a0034087']
1690,23051942,Psychological well-being in medical students during exam stress-influence of short-term practice of mind sound technology.,"INTRODUCTION


Medical education is perceived as stressful. As excessive stress hampers students' performance, stress management is required for medical students. This study was aimed to assess the effect of Mind Sound Technology (MST), an intelligence enhancing program, on psychological well-being of medical undergraduates during exam stress.
MATERIALS AND METHODS


Forty-two medical students were recruited and Dukes Health Profile scoring was done at baseline and during Exam Stress (ES). After pre-intervention measurements, the students were randomized into two groups: non-practitioners and MST practitioners. Post-intervention measurement was done at the end of 6 weeks when the students had examination.
RESULTS


Students showed a significant increase (P < 0.001) in negative health scores like perceived health scores, anxiety, and depression and a significant decrease (P < 0.001) in positive health scores like Self-Esteem, Mental Health Score, Social Health Score, and General Health Score during exam when compared with baseline. MST practice increased positive health scores (P < 0.001) and decreased perceived health score (P < 0.01), anxiety, depression, and anxiety-depression scores significantly (P < 0.001) when compared with ES score. Non practitioners did not show any significant change in any of the scores when compared with ES score. Six weeks of MST practice by medical students have improved the academic scores (P < 0.05) when compared with their non-practitioner counterpart.
CONCLUSION


Thus, practice of MST has helped in coping up the stress that occurs during examination and improved academic performance in medical undergraduates.",2010,"MST practice increased positive health scores (P < 0.001) and decreased perceived health score (P < 0.01), anxiety, depression, and anxiety-depression scores significantly (P < 0.001) when compared with ES score.","['medical undergraduates', 'Forty-two medical students were recruited and Dukes']",['Mind Sound Technology (MST'],"['negative health scores like perceived health scores, anxiety, and depression', 'academic scores', 'academic performance', 'positive health scores', 'anxiety, depression, and anxiety-depression scores', 'health score', 'positive health scores like Self-Esteem, Mental Health Score, Social Health Score, and General Health Score']","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0036373', 'cui_str': 'Academic Performance'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder (disorder)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",42.0,0.0345326,"MST practice increased positive health scores (P < 0.001) and decreased perceived health score (P < 0.01), anxiety, depression, and anxiety-depression scores significantly (P < 0.001) when compared with ES score.","[{'ForeName': 'Haripriya', 'Initials': 'H', 'LastName': 'Dayalan', 'Affiliation': 'Department of Medical Research, SRM Medical College Hospital and Research Centre, Kattankulathur-603203, India. dhpsrm@yahoo.in'}, {'ForeName': 'Swapna', 'Initials': 'S', 'LastName': 'Subramanian', 'Affiliation': ''}, {'ForeName': 'Tamilselvi', 'Initials': 'T', 'LastName': 'Elango', 'Affiliation': ''}]",Indian journal of medical sciences,['10.4103/0019-5359.102122']
1691,31870091,Effectiveness of a School-Based 'Tobacco Free' Intervention on Adolescents' Knowledge and Exposure to Second Hand Tobacco Smoke - A Multiphase Study.,"BACKGROUND


There is no safe level of exposure to second hand tobacco smoke (SHS). The World Health Organization has stressed that 100% smoke-free environments are the only effective way to protect the population from the harmful effects of exposure to SHS.
DESIGN


A multiphase study with a descriptive cross-sectional questionnaire phase 1  and a phase 2 cluster randomized controlled trial (RCT), conceptualized to determine the effectiveness of a school-based 'tobacco free' health education intervention on adolescents' knowledge and attitude towards SHS.
METHODS


Baseline assessment will include a questionnaire followed by estimation of salivary cotinine levels. The experimental arm will receive the 'tobacco free' intervention, which includes 40 min health education session delivered once a week for 3 consecutive weeks. Participants will also be given 'take home brochures' every week containing messages on the effects of tobacco and how to make their homes smoke-free. The sample of 250 participants, for the Phase 2 RCT, with salivary cotinine levels of > 0.1 ng/mL will be selected from the participants of the Phase 1 study. The effect of the intervention will be quantitatively assessed by estimating the salivary cotinine levels after the intervention. Participants in the control arm will receive conventional standard health education once.
CONCLUSION


This research will help in assessing if there is any change in the salivary cotinine levels and the knowledge, attitude and behaviour scores after the health educational intervention and help in developing an effective school-based 'tobacco free' intervention program which could be incorporated into the school curriculum. This study has received the Public Health Research Initiative (PHRI) Research Grant of Rs. 18,99,205 and is registered with the Clinical Trial Registry of India (CTRI) with number CTRI/2018/09/015706 (Registered on 13/09/2018). Ethical approval has been obtained from The Institutional Ethics Committee (No.17021 dated 13 march 2017).",2019,"The experimental arm will receive the 'tobacco free' intervention, which includes 40 min health education session delivered once a week for 3 consecutive weeks.","[""adolescents' knowledge and attitude towards SHS"", 'The sample of 250 participants, for the Phase 2 RCT, with salivary cotinine levels of > 0.1 ng/mL will be selected from the participants of the Phase 1 study']","[""school-based 'tobacco free' health education intervention"", ""School-Based 'Tobacco Free' Intervention"", 'conventional standard health education once']",['salivary cotinine levels'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0018701'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",250.0,0.0536523,"The experimental arm will receive the 'tobacco free' intervention, which includes 40 min health education session delivered once a week for 3 consecutive weeks.","[{'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Rao', 'Affiliation': 'Department of Public Health Dentistry, Manipal College of Dental Sciences, Mangalore, India.'}, {'ForeName': 'Unnikrishnan', 'Initials': 'U', 'LastName': 'B', 'Affiliation': 'Department of Community Medicine, Kasturba Medical College, Mangalore, India.'}, {'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Mithra', 'Affiliation': 'Department of Community Medicine, Kasturba Medical College, Mangalore, India.'}, {'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'M', 'Affiliation': 'Department of Biochemistry, Kasturba Medical College, Mangalore, A constituent unit of Manipal Academy of Higher Education (MAHE), Manipal, India.'}, {'ForeName': 'Ramya', 'Initials': 'R', 'LastName': 'Shenoy', 'Affiliation': 'Department of Public Health Dentistry, Manipal College of Dental Sciences, Mangalore, India.'}, {'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'Rungta', 'Affiliation': 'Department of Public Health Dentistry, Manipal College of Dental Sciences, Mangalore, India.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2019.20.12.3533']
1692,24231395,The effect of a healthy lifestyle program on the elderly's health in Arak.,"BACKGROUND


Increasing life-expectancy and decreasing birth rate have led to an increase in the elderly population worldwide so that the aging population is considered one of the biggest public health concerns in the present century which demands more attention to this vulnerable group. Therefore, the present study was done to determine the effect of a healthy lifestyle program on elderly's health in Arak.
MATERIALS AND METHODS


This quasi-experimental intervention study was carried out on 60 elderly citizens of Arak. The participants attended four instructional classes on nutrition, exercise, sleep hygiene, life skills, and personal hygiene over one month and they were followed for three months after the intervention. Data were collected through standard quality of life questionnaire (SF-36) and Katz standard ADLs in the elderly questionnaire before and three months after the completion of the study.
RESULTS


The average age of the participants was 67.61 ± 5.02 years. In terms of gender, the majority of the participants (60%) were male. In terms of quality of life before the instructional intervention, 13.3% of the participants were in low level, 30% in average level, 41.7% in good level, and 15% in the high level of quality of life. However, after the intervention, the majority of the participants were in good (38.3%) and high (45%) levels of quality of life which showed significant differences before and after the instructional intervention (P < 0.001). Moreover, there was a significant difference between Katz ADLs in the elderly before and after the intervention (P < 0.001).
CONCLUSION


The comparison between the quality of life and ADLs in the elderly before and after the intervention showed that continuing instruction for the elderly based on a regular healthy lifestyle program is effective and holding different instructional classes for this population, that is often ignored, seems necessary. The findings of this study can help design proper instructional guidelines on healthy lifestyle in the elderly.",2013,"In terms of quality of life before the instructional intervention, 13.3% of the participants were in low level, 30% in average level, 41.7% in good level, and 15% in the high level of quality of life.","['healthy lifestyle in the elderly', ""elderly's health in Arak"", '60 elderly citizens of Arak']",['healthy lifestyle program'],"['quality of life', 'levels of quality of life', 'nutrition, exercise, sleep hygiene, life skills, and personal hygiene', 'Katz ADLs', 'standard quality of life questionnaire (SF-36) and Katz standard ADLs']","[{'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0034380'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0564673', 'cui_str': 'Personal hygiene activities, function (observable entity)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",60.0,0.0266922,"In terms of quality of life before the instructional intervention, 13.3% of the participants were in low level, 30% in average level, 41.7% in good level, and 15% in the high level of quality of life.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hekmatpou', 'Affiliation': 'Assistant Professor, Ph.D in Health Education, Arak, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shamsi', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zamani', 'Affiliation': ''}]",Indian journal of medical sciences,['10.4103/0019-5359.121119']
1693,24231396,Effect of inhaled fluticasone and salmeterol on tracheal responsiveness and lung inflammation: influence of administration time and allergen-free period.,"BACKGROUND


The effect of inhaled fluticasone propionate (FP) and salmeterol (SM) on tracheal responsiveness (TR) to methacholine and lung pathology of sensitized guinea pig was examined.
MATERIALS AND METHODS


Six groups of guinea pigs (n = 7) were sensitized to ovalbumin (OA). Three groups were subjected to inhaled FP and SM, one group during (A), one group after sensitization (for 18 days, B) and other group during sensitization but with 18-days delay before measurements (C). Other three groups were treated with placebo.
RESULTS


The TR to methacholine and tracheal muscle contractility were significantly higher than those of control group (P < 0.001 for all cases). The lungs of placebo groups showed variable pathological changes (nonsignificant to P < 0.001) compared to control group. TR, intra-alveolar and interabronchoal hemorrhagie (P < 0.001 in only group A) in treated groups with FP and SM were significantly decreased compared to placebo groups. The improvement in all variables in treatment groups A and C were more pronounced than group B.
CONCLUSION


These results showed a protective effect of FP and SM on tracheal responsiveness and lung pathology during sensitization which was more effective than after sensitization.",2013,The lungs of placebo groups showed variable pathological changes (nonsignificant to P < 0.001) compared to control group.,['Six groups of guinea pigs (n = 7) were'],"['inhaled FP and SM', 'placebo', 'FP and SM', 'inhaled fluticasone propionate (FP) and salmeterol (SM', 'sensitized to ovalbumin (OA', 'inhaled fluticasone and salmeterol']","['tracheal responsiveness (TR', 'variable pathological changes', 'TR, intra-alveolar and interabronchoal hemorrhagie ', 'tracheal responsiveness and lung pathology', 'TR to methacholine and tracheal muscle contractility', 'tracheal responsiveness and lung inflammation']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0085979', 'cui_str': 'Cavia'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C0029923', 'cui_str': 'Ovalbumin'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}]","[{'cui': 'C2945595', 'cui_str': 'Tracheal (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0600370', 'cui_str': 'Methacholine'}, {'cui': 'C0225595', 'cui_str': 'Structure of tracheal muscle'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]",7.0,0.0245,The lungs of placebo groups showed variable pathological changes (nonsignificant to P < 0.001) compared to control group.,"[{'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Khazdair', 'Affiliation': 'Applied Physiology Research Centre and Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Boskabady', 'Affiliation': ''}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Tabatabaee', 'Affiliation': ''}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Hosseini', 'Affiliation': ''}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Abbasnejad', 'Affiliation': ''}]",Indian journal of medical sciences,['10.4103/0019-5359.121121']
1694,31541747,Phase 2 trial of a neurokinin-1 receptor antagonist for the treatment of chronic itch in patients with epidermolysis bullosa: A randomized clinical trial.,"BACKGROUND


Chronic pruritus causes major morbidity in epidermolysis bullosa (EB). The substance P-neurokinin 1 receptor (SP-NK1) pathway is a promising target for treating EB-related pruritus.
OBJECTIVE


To evaluate the safety and efficacy of the oral NK1 receptor antagonist serlopitant in treating moderate-severe pruritus in EB.
METHODS


The study randomized 14 patients to serlopitant or placebo for 8 weeks, followed by a 4-week washout and optional open-label extension. The primary end point was change in itch as measured by the Numeric Rating Scale. Secondary end points were change in itch during dressing changes and wound size.
RESULTS


We observed greater itch reduction with serlopitant, equivalent to a 0.64-point comparative reduction on the 11-point Numeric Rating Scale by week 8, although this failed to meet statistical significance (P = .11). More serlopitant patients achieved ≥3-point reduction compared with placebo (43% vs 14%, P = .35). In post hoc analysis excluding 1 patient with a concurrent seborrheic dermatitis flare, serlopitant achieved significantly greater median itch reduction from baseline by week 4 (-2 points vs 0, P = .01). We observed no statistically significant differences in secondary end points. Serlopitant was well-tolerated.
LIMITATIONS


Small sample size due to disease rarity.
CONCLUSION


The potential itch reduction with serlopitant observed in this trial will be pursued by a larger powered trial (NCT03836001).",2020,"More serlopitant patients achieved ≥3-point reduction compared to placebo (43% vs. 14%, p=0.35).","['moderate-severe pruritus in EB', '14 patients', 'Epidermolysis Bullosa Patients']","['placebo', 'Neurokinin-1 Receptor Antagonist', 'serlopitant or placebo', 'oral NK1 receptor antagonist serlopitant']","['median itch reduction', 'tolerated', 'change in: (1) itch during dressing changes and (2) wound size', '≥3-point reduction', '11-point NRS', 'change in itch as measured by a numeric rating scale (NRS', 'safety and efficacy']","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014527', 'cui_str': 'Acantholysis Bullosa'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521486', 'cui_str': 'Neurokinin 1 receptor antagonist'}, {'cui': 'C2825662', 'cui_str': 'serlopitant'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0085671', 'cui_str': 'Dressing change'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.109546,"More serlopitant patients achieved ≥3-point reduction compared to placebo (43% vs. 14%, p=0.35).","[{'ForeName': 'Albert S', 'Initials': 'AS', 'LastName': 'Chiou', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Redwood City, California. Electronic address: achiou@stanford.edu.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Redwood City, California.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Barriga', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Redwood City, California.'}, {'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Dutt-Singkh', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Redwood City, California.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Solis', 'Affiliation': 'Department of Internal Medicine, University of California, Riverside, California.'}, {'ForeName': 'Jaron', 'Initials': 'J', 'LastName': 'Nazaroff', 'Affiliation': 'University of California, Irvine School of Medicine, Irvine, California.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Bailey-Healy', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Redwood City, California.'}, {'ForeName': 'Shufeng', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Redwood City, California.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Shu', 'Affiliation': 'Menlo Therapeutics Inc (formerly Tigercat Pharma, Inc), Redwood City, California.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Joing', 'Affiliation': 'Menlo Therapeutics Inc (formerly Tigercat Pharma, Inc), Redwood City, California.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kwon', 'Affiliation': 'Menlo Therapeutics Inc (formerly Tigercat Pharma, Inc), Redwood City, California.'}, {'ForeName': 'Jean Y', 'Initials': 'JY', 'LastName': 'Tang', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Redwood City, California.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.09.014']
1695,23023308,Efficacy of esmolol administration at different time intervals in attenuating hemodynamic response to tracheal intubation.,"BACKGROUND


Laryngoscopy and endotracheal intubation are known to cause increase in both arterial blood pressure and heart rate. Several strategies have been evolved to blunt the haemodynamic response to tracheal intubation but each method has its own advantages and disadvantages. Esmolol, a cardio selective Beta-1 blocking drug, can alleviate some of these problems. Esmolol, when administered parenterally, exhibits rapid onset and a short duration of action due to its rapid clearance by red blood cell esterases. Hence we conducted the present study to evaluate the efficacy and optimum time of single bolus esmolol administration in attenuating hypertensive- tachycardiac response to laryngoscopy and tracheal intubation.
MATERIALS AND METHODS


The randomized double blind prospective study was conducted in 60 patients, in the age group of 20-40 years, of both sexes, belonging to American Society of Anaesthesiologists (ASA) physical status class I or II and scheduled for elective surgery requiring endotracheal intubation and general anaesthesia. The efficacy and optimum time of single bolus esmolol administration in attenuating hypertensive - tachycardiac response to laryngoscopy and tracheal intubation was evaluated. Patients in group I (n = 20) received bolus administration of injection esmolol 1.5 mg/kg intravenously (iv) 90 seconds before intubation; in group II (n = 20) three minutes before intubation and in group III (n = 20) six minutes before intubation.
RESULTS


There was no clinical and statistically significant variation in heart rate in group I and II at different time intervals of the study period but in group III heart rate increased significantly one minute after tracheal intubation. (P < 0.05) One minute after intubation, the increase in systolic, diastolic and mean blood pressure and rate pressure product was statistically significant in group I (P < 0.01) and group III. (P < 0.05) However, in group II increase in systolic blood pressure and rate pressure product was statistically not significant. (P > 0.05)
CONCLUSION


To conclude, single intravenous bolus dose of esmolol (1.5 mg/kg) is safe and more effective in attenuating haemodynamic response to laryngoscopy and tracheal intubation when administered three minutes prior to intubation.",2010,There was no clinical and statistically significant variation in heart rate in group I and II at different time intervals of the study period but in group III heart rate increased significantly one minute after tracheal intubation.,"['tracheal intubation', '60 patients, in the age group of 20-40 years, of both sexes, belonging to American Society of Anaesthesiologists (ASA) physical status class']","['esmolol', 'bolus administration of injection esmolol', 'elective surgery requiring endotracheal intubation and general anaesthesia', 'Esmolol']","['systolic, diastolic and mean blood pressure and rate pressure product', 'heart rate', 'arterial blood pressure and heart rate', 'hemodynamic response', 'systolic blood pressure and rate pressure product', 'haemodynamic response', 'hypertensive - tachycardiac response to laryngoscopy and tracheal intubation']","[{'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C0116569', 'cui_str': 'esmolol'}, {'cui': 'C1533685', 'cui_str': 'Injection - action (qualifier value)'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}]",,0.073008,There was no clinical and statistically significant variation in heart rate in group I and II at different time intervals of the study period but in group III heart rate increased significantly one minute after tracheal intubation.,"[{'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Singhal', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Pt. B.D. Sharma PGIMS, Rohtak-124001, India.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Malhotra', 'Affiliation': ''}, {'ForeName': 'Kiranpreet', 'Initials': 'K', 'LastName': 'Kaur', 'Affiliation': ''}, {'ForeName': 'Dharmender', 'Initials': 'D', 'LastName': 'Dhaiya', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1696,22945778,Effect of lidocaine gel on pain from copper IUD insertion: a randomized double-blind controlled trial.,"CONTEXT


Insertion pain or fear of it may make women hesitate to use the intrauterine device (IUD); a long-term, reversible, highly-effective contraception method. Further study has been recommended on the effects of lidocaine (xylocaine) gel on IUD insertion pain in the recent Cochran review.
AIMS


To determine the effect of lidocaine gel on pain from TCu-380AIUD insertion.
MATERIALS AND METHODS


At a health center in Tabriz, Iran, 96 women were allocated into 3 groups using block randomization with 6 and 9 block sizes considering allocation concealment. In 1 st group, lidocaine 2% gel and in the 2 nd , lubricant gel was placed in the cervical canal 1 minute before an IUD insertion, and the 3 rd group got no intervention. Immediately after IUD insertion, pain during the insertion was measured using 0-10 cm visual analogue scale.
STATISTICAL ANALYSIS USED


Kruskal-Wallis and linear regression in SPSS-13 were used to identify effect of lidocaine gel on the pain.
RESULTS


Overall, the mean pain score was 3.5 ± 1.8. In univariate analysis, there was no significant difference in pain scores between the 3 groups. Also, results of linear regression model by controlling effect of the possible confounding showed no significant effect of lidocaine gel on the insertion pain. The mean pain score in the lidocaine group was 0.39 less than the no intervention group, but it was not significant (CI 95% of the difference: -1.3, 0.57).
CONCLUSIONS


Use of 2% lidocaine gel into the cervical canal has no effect on reducing overall pain during IUD insertion.",2010,"The mean pain score in the lidocaine group was 0.39 less than the no intervention group, but it was not significant (CI 95% of the difference: -1.3, 0.57).
","['At a health center in Tabriz, Iran, 96 women']","['lidocaine', 'lidocaine gel', 'lidocaine (xylocaine) gel']","['pain', 'pain from copper IUD insertion', 'pain scores', 'mean pain score', 'insertion pain', 'overall pain']","[{'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0373587', 'cui_str': 'Copper measurement (procedure)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",96.0,0.434648,"The mean pain score in the lidocaine group was 0.39 less than the no intervention group, but it was not significant (CI 95% of the difference: -1.3, 0.57).
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mohammad-Alizadeh-Charandabi', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Seidi', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Kazemi', 'Affiliation': ''}]",Indian journal of medical sciences,['10.4103/0019-5359.100337']
1697,23548251,Efficacy of misoprostol administration 24 hours after mifepristone for termination of early pregnancy.,"INTRODUCTION


Mifepristone and misoprostol are the two drugs which are given at 36-48 h interval for medical abortion. This study was designed to study the efficacy of early administration of misoprostol (24 h after mifepristone) for medical termination of pregnancy less than 9 weeks and to compare this with standard protocol of mifepristone misoprostol combination at 48 h interval.
MATERIALS AND METHODS


Subjects for this single center prospective randomized case-control study were enrolled from the family planning outdoor patient department at our hospital with gestational age of less than 9 weeks. All subjects initially received 200 mg of oral mifepristone and then were randomly assigned to receive per vaginal 400 μg misoprostol at 24 h (study group) and 48 h (control group). They were then followed up after 14 days with transvaginal sonography to confirm completion of expulsion. Treatment was considered failed if surgical evacuation was needed for any indication. Primary outcome measure was success rate of the two treatment regimens.
RESULTS


Totally, 200 subjects were randomly allocated to each treatment arm (100 each). Complete expulsion was seen in 94% (94/100) in study group and 95% (95/100) in control group according to intention to treat analysis (P value ns). According to per protocol analysis success rate in study group was 93.6% and 94.3% in control group (P value ns). High failure rate after 7 weeks period of gestation in both the study and control group was found (26.3% and 30.0%; P value ns). Adverse effects were mostly similar in both the groups.
CONCLUSION


Efficacy of mifepristone misoprostol combination at 24 h interval was similar to that at 48 h interval for medical abortion of pregnancy less than 9 weeks without compromising the safety .",2011,Efficacy of mifepristone misoprostol combination at 24 h interval was similar to that at 48 h interval for medical abortion of pregnancy less than 9 weeks without compromising the safety .,"['Subjects for this single center prospective randomized case-control study were enrolled from the family planning outdoor patient department at our hospital with gestational age of less than 9 weeks', '200 subjects']","['oral mifepristone', 'transvaginal sonography', 'mifepristone misoprostol combination', 'Mifepristone and misoprostol', 'misoprostol', 'vaginal 400 μg misoprostol', 'mifepristone']","['success rate of the two treatment regimens', 'Complete expulsion', 'Adverse effects', 'medical abortion of pregnancy less', 'High failure rate']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0007328', 'cui_str': 'Case-Referrent Studies'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1293107', 'cui_str': 'Expulsion (procedure)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3146283', 'cui_str': 'Medical abortion'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",200.0,0.250849,Efficacy of mifepristone misoprostol combination at 24 h interval was similar to that at 48 h interval for medical abortion of pregnancy less than 9 weeks without compromising the safety .,"[{'ForeName': 'Manju Lata', 'Initials': 'ML', 'LastName': 'Verma', 'Affiliation': 'Department of Obstetrics and Gynecology, Chathrapati Shahuji Maharaj Medical University, Lucknow, Uttar Pradesh, India. gaganmlv@gmail.com'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'Pushpalata', 'Initials': 'P', 'LastName': 'Shankhwar', 'Affiliation': ''}, {'ForeName': 'Deepali', 'Initials': 'D', 'LastName': 'Srivastava', 'Affiliation': ''}]",Indian journal of medical sciences,['10.4103/0019-5359.109900']
1698,23529834,Efficacy of early treatment on 52 patients with preneoplastic hepatitis B virus-associated hepatocellular carcinoma by compound Phyllanthus Urinaria L.,"OBJECTIVE


To observe the change in the number of antibodies of preneoplastic hepatocellular carcinoma (HCC) using early treatment by Compound Phyllanthus Urinaria L. (CPUL) on patients with preneoplastic hepatitis B virus (HBV)-associated HCC.
METHODS


A total of 102 cirrhosis patients with regenerative or dysplastic nodules whose sera were tested positive for at least one of these six proteins (five up-regulated genes URG4, URG7, URG11, URG12 and URG19, and one down-regulated gene DRG2) were assigned randomly to two groups using continual random codes by SPSS software. Fifty-two patients were in the treatment group and 50 patients were in the control group. CPUL was used in the treatment group for 3 years, while the control group did not receive any treatment. The changes in HBV-DNA level, number of antibodies, and hepatocarcinogenesis occurred were observed. Patients who did not develop HCC were followed up for another 2 years.
RESULTS


HBV-DNA levels decreased ⩾2log in 22.2% (10/45) of patients in the treatment group in contrast to only 5.0% (2/40) of patients in the control group (P=0.0228). The number of antibodies that were tested positive in the treatment group (1.08±1.01) was significantly lower compared with the control group (2.11±1.12) after 24 months of drug treatment (P<0.01). Both the positive rates of anti-URG11 (33/52) and anti-URG19 (31/52) were over 60% at baseline in the two groups, and were decreased to 48.1% (25/52) and 46.2% (24/52) respectively at 36 months of drug treatment, while the rates increased to 68.0% (34/50) and 66.0% (33/50) respectively (P=0.0417, P=0.0436) in the control group. The positive rate of anti-DRG2 was increased to 55.8% (29/52) at 36 months of drug treatment, while in the control group was decreased to 36.0% (18/50, P=0.0452). Among the 102 patients who developed HCC, 2 were in the treatment group and 9 were in the control group, meaning that a significant difference between the two groups (P=0.0212). In 11 patients who developed HCC, anti-URG11 and anti-URG19 were always positive, while anti-DRG2 was negative. Patients newly developing HCC were 6 (20.0%) in the control group, and only one (2.5%) in the treatment group (P=0.0441) during 2-year follow-up after the end of the treatment.
CONCLUSIONS


Anti-URG11, anti-URG19 and anti-DRG2 could be used as early markers in the prediction of the therapeutic efficacy of CPUL in treating preneoplastic HCC. CPUL is useful in preventing or delaying the development of HBV-associated cirrhosis to HCC.",2014,"RESULTS


HBV-DNA levels decreased ⩾2log in 22.2% (10/45) of patients in the treatment group in contrast to only 5.0% (2/40) of patients in the control group (P=0.0228).","['52 patients with preneoplastic hepatitis B virus-associated hepatocellular carcinoma by compound Phyllanthus Urinaria L', '102 cirrhosis patients with regenerative or dysplastic nodules whose sera', 'patients with preneoplastic hepatitis B virus (HBV)-associated HCC']","['Compound Phyllanthus Urinaria L. (CPUL', 'CPUL']","['HBV-DNA levels', 'HBV-DNA level, number of antibodies, and hepatocarcinogenesis', 'number of antibodies', 'positive rates of anti-URG11 (33/52) and anti-URG19', 'positive rate of anti-DRG2']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}, {'cui': 'C0330590', 'cui_str': 'Phyllanthus'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C3163961', 'cui_str': 'Dysplastic nodule'}]","[{'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}, {'cui': 'C0330590', 'cui_str': 'Phyllanthus'}]","[{'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",102.0,0.0290831,"RESULTS


HBV-DNA levels decreased ⩾2log in 22.2% (10/45) of patients in the treatment group in contrast to only 5.0% (2/40) of patients in the control group (P=0.0228).","[{'ForeName': 'Guang-dong', 'Initials': 'GD', 'LastName': 'Tong', 'Affiliation': 'Department of Liver Disease, Shenzhen Hospital Affiliated to Guangzhou University of Chinese Medicine, Shenzhen, Guangdong Province, 518033, China. tgd755@163.com.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Liver Disease, Shenzhen Hospital Affiliated to Guangzhou University of Chinese Medicine, Shenzhen, Guangdong Province, 518033, China.'}, {'ForeName': 'Da-qiao', 'Initials': 'DQ', 'LastName': 'Zhou', 'Affiliation': 'Department of Liver Disease, Shenzhen Hospital Affiliated to Guangzhou University of Chinese Medicine, Shenzhen, Guangdong Province, 518033, China.'}, {'ForeName': 'Chun-shan', 'Initials': 'CS', 'LastName': 'Wei', 'Affiliation': 'Department of Liver Disease, Shenzhen Hospital Affiliated to Guangzhou University of Chinese Medicine, Shenzhen, Guangdong Province, 518033, China.'}, {'ForeName': 'Jin-song', 'Initials': 'JS', 'LastName': 'He', 'Affiliation': 'Department of Liver Disease, Shenzhen Hospital Affiliated to Guangzhou University of Chinese Medicine, Shenzhen, Guangdong Province, 518033, China.'}, {'ForeName': 'Chun-ling', 'Initials': 'CL', 'LastName': 'Xiao', 'Affiliation': 'Department of Liver Disease, Shenzhen Hospital Affiliated to Guangzhou University of Chinese Medicine, Shenzhen, Guangdong Province, 518033, China.'}, {'ForeName': 'Xin-liang', 'Initials': 'XL', 'LastName': 'Liu', 'Affiliation': 'Department of Liver Disease, Shenzhen Hospital Affiliated to Guangzhou University of Chinese Medicine, Shenzhen, Guangdong Province, 518033, China.'}, {'ForeName': 'Ying-jun', 'Initials': 'YJ', 'LastName': 'Zheng', 'Affiliation': 'Department of Liver Disease, Shenzhen Hospital Affiliated to Guangzhou University of Chinese Medicine, Shenzhen, Guangdong Province, 518033, China.'}, {'ForeName': 'Si-nuan', 'Initials': 'SN', 'LastName': 'Chen', 'Affiliation': 'Department of Liver Disease, Shenzhen Hospital Affiliated to Guangzhou University of Chinese Medicine, Shenzhen, Guangdong Province, 518033, China.'}, {'ForeName': 'Hai-hong', 'Initials': 'HH', 'LastName': 'Tang', 'Affiliation': 'Department of Liver Disease, Shenzhen Hospital Affiliated to Guangzhou University of Chinese Medicine, Shenzhen, Guangdong Province, 518033, China.'}]",Chinese journal of integrative medicine,['10.1007/s11655-013-1320-7']
1699,23525022,Effect of early elbow crutch mobility on patients with post-anterior cruciate ligament repair.,"OBJECTIVE


Rehabilitation after anterior cruciate ligament (ACL) reconstruction has focused over the past decade on early mobility and exercises in the recent years, due to advancements in the surgical techniques, presumably less strain on the graft. Thus it was necessary to investigate the effect of early mobilization with the single elbow crutch with conventional methods and its outcome responses.
MATERIALS AND METHODS


Totally, 40 subjects of day 1 post-ACL oblique repair with mean age of 25 ± 5.3 years participated in the study. Subjects were divided into experimental and control groups for rehabilitation with single elbow crutch and walker, respectively, along with conventional exercises for 6 weeks. After 4th week elbow crutch and walker were discarded for both groups. Interventional outcomes were assessed by static, dynamic stability, and knee functional score at 4th and 6th weeks post-operatively for both groups.
RESULTS


Both groups showed statistically significant difference in static and dynamic stability at 4th and 6th weeks. Whereas compared with experimental group, in control group Lysholm functional score was low in at 4th and 6th weeks. It was found that outcomes were improved within each group from 4th to 6th week.
CONCLUSION


Study concluded that knee stability and Lysholm functional Knee Score were significantly improved by early mobilization although functional score was more significant in single elbow crutch group than walker and also recommended early weaning off walking aids for faster outcomes during rehabilitation of post-ACL repair.",2011,"CONCLUSION


Study concluded that knee stability and Lysholm functional Knee Score were significantly improved by early mobilization although functional score was more significant in single elbow crutch group than walker and also recommended early weaning off walking aids for faster outcomes during rehabilitation of post-ACL repair.","['patients with post-anterior cruciate ligament repair', 'Totally, 40 subjects of day 1 post-ACL oblique repair with mean age of 25 ± 5.3 years participated in the study', 'anterior cruciate ligament (ACL) reconstruction']",['early elbow crutch mobility'],"['static and dynamic stability', 'static, dynamic stability, and knee functional score', 'knee stability and Lysholm functional Knee Score', 'Lysholm functional score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0078960', 'cui_str': 'Anterior Cranial Cruciate Ligament'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205315', 'cui_str': 'Oblique (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C3877748', 'cui_str': 'Elbow crutch'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}]","[{'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",40.0,0.0239832,"CONCLUSION


Study concluded that knee stability and Lysholm functional Knee Score were significantly improved by early mobilization although functional score was more significant in single elbow crutch group than walker and also recommended early weaning off walking aids for faster outcomes during rehabilitation of post-ACL repair.","[{'ForeName': 'Shaji John', 'Initials': 'SJ', 'LastName': 'Kachanathu', 'Affiliation': 'Department of Rehabilitation Health Sciences, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ashraf Ramadan', 'Initials': 'AR', 'LastName': 'Hafez', 'Affiliation': ''}, {'ForeName': 'Abdul Rahim', 'Initials': 'AR', 'LastName': 'Zakaria', 'Affiliation': ''}]",Indian journal of medical sciences,['10.4103/0019-5359.109529']
1700,23525025,Comparison of gastrointestinal symptoms at daily 10 mg versus weekly 70 mg Alendronate prescription in 195 osteoporotic cases.,"BACKGROUND


Osteoporosis is defined as a reduction of bone density or the presence of a fragility fracture. One class of new antiosteoporotic drugs is the bisphosphonates. Oral bisphosphonates seems to induce serious gastrointestinal (GI) side effects in some patients. The aim of the study is to comparison the GI symptoms of Alendronate daily 10mg versus weekly 70mg administration in osteoporotic patients during 8 weeks.
MATERIALS AND METHODS


This is a clinical trial study that was conducted in the department of Internal Medicine, Shohada Ashayer Hospital, Khorramabad, Iran, 2002-2007. 195 osteoporotic patients selected for this study. They separated in three groups (first group: Placebo for eight weeks, 2 nd group 70 mg Alendronate at single dose per weeks for eight weeks and 3 rd group 10 mg Alendronate per day for 8 weeks). Then GI symptoms were detected for each person at different groups.
STATISTICAL ANALYSIS


The Data was analyzed with Chi-square test and ANOVA.
RESULTS


comparison of mean of complications between groups shows that the patients in placebo group had lesser complications (P < 0.001). Comparison of each symptom between patients in 2 nd and 3 rd groups shows that only eructation had lesser frequency in first group of patients and other complications had not significant difference during 8 weeks of treatment.
CONCLUSION


there is significant differences in GI symptoms between placebo and Alendronate but between Alendronate in doses of 10mg per day and 70 mg per week had not significant difference. Using of Alendronate must be cautiously because of producing severe GI disorders.",2011,"RESULTS


comparison of mean of complications between groups shows that the patients in placebo group had lesser complications (P < 0.001).","['195 osteoporotic patients selected for this study', 'osteoporotic patients during 8 weeks', '195 osteoporotic cases', 'department of Internal Medicine, Shohada Ashayer Hospital, Khorramabad, Iran, 2002-2007']","['placebo and Alendronate', 'placebo', 'Placebo', 'Oral bisphosphonates', 'Alendronate', 'Alendronate prescription']","['lesser complications', 'GI symptoms', 'mean of complications']","[{'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",195.0,0.0784838,"RESULTS


comparison of mean of complications between groups shows that the patients in placebo group had lesser complications (P < 0.001).","[{'ForeName': 'Aref Hosseinian', 'Initials': 'AH', 'LastName': 'Amiri', 'Affiliation': 'Department of Internal medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Mohammad Javad', 'Initials': 'MJ', 'LastName': 'Tarrahi', 'Affiliation': ''}]",Indian journal of medical sciences,['10.4103/0019-5359.109536']
1701,23511042,Effect of yogic exercises on symptoms of musculoskeletal disorders of upper limbs among computer users: a randomised controlled trial.,"BACKGROUND AND OBJECTIVES


Upper extremity musculoskeletal disorders (MSD) are very common in regular computer users and leading cause of work related illness. The objective of the present study is to evaluate effectiveness of yogic exercises in the improvement of symptoms of MSDs of upper limbs.
MATERIALS AND METHODS


60 study participants were randomly divided into two groups that is yoga with counselling and only counselling group for 12 weeks. Symptom severity and functional status were assessed using the self administered Boston Carpal Tunnel Questionnaire and predesigned symptom questionnaire before and after intervention.
RESULTS


There was significant reduction in symptom severity score (P = 0.002) and improvement in functional status score in yoga with counselling group when compared to only counselling group. There is also a significant decrease in self reported symptoms like CT myalgia symptom (P = 0.019) and improvement in weakness.
CONCLUSION


The present study showed a yoga based regimen is more effective than counselling alone in relieving symptoms of computer related musculoskeletal disorders.",2011,"There is also a significant decrease in self reported symptoms like CT myalgia symptom (P = 0.019) and improvement in weakness.
","['Upper extremity musculoskeletal disorders (MSD', '60 study participants', 'musculoskeletal disorders of upper limbs among computer users']","['yogic exercises', 'yoga with counselling and only counselling group']","['weakness', 'symptom severity score', 'self administered Boston Carpal Tunnel Questionnaire and predesigned symptom questionnaire', 'self reported symptoms like CT myalgia symptom', 'Symptom severity and functional status', 'functional status score']","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0026857', 'cui_str': 'Orthopedic Disorders'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3714552', 'cui_str': 'Weakness - general'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",60.0,0.029569,"There is also a significant decrease in self reported symptoms like CT myalgia symptom (P = 0.019) and improvement in weakness.
","[{'ForeName': 'Vidya S', 'Initials': 'VS', 'LastName': 'Joshi', 'Affiliation': 'Department of Physiology, Vydehi Institute of Medical Sciences and Research Centre Bangalore, India. sunvascular@gmail.com'}, {'ForeName': 'Anjana S', 'Initials': 'AS', 'LastName': 'Bellad', 'Affiliation': ''}]",Indian journal of medical sciences,['10.4103/0019-5359.109256']
1702,23391831,Clinical efficacy of subgingivally delivered 0.5% controlled release azithromycin gel in the management of chronic periodontitis.,"BACKGROUND


Recent developments suggest that the local delivery of antimicrobials into periodontal pockets can improve periodontal health. Azithromycin (AZM) has a wide antimicrobial spectrum of action toward anaerobic bacteria as well as Gram-negative bacilli. It is effective against periodontal pathogens such as Aggregatibacter actinomycetemcomitans and Porphyromonas gingivalis. Therefore, this study was undertaken to investigate the clinical effectiveness of AZM at 0.5% concentration in an indigenously prepared bioabsorbable controlled release gel as an adjunct to non-surgical mechanical therapy in the treatment of chronic periodontitis.
MATERIALS AND METHODS


Thirty sites in patients with chronic periodontitis and probing depth (PD) 4-6 mm were categorized randomly into two treatment groups: Scaling and root planing (SRP) plus 0.5% AZM gel (group 1) and SRP only (group 2). Clinical evaluation was undertaken using the Gingival Index (GI) of Loe and Silness and plaque was assessed using the Turesky et al. modification of Quigley Hein Index at baseline and 21 days. Pocket PD and clinical attachment level (CAL) were also measured.
STATISTICAL ANALYSIS


Results were expressed as mean±standard deviation and percentages and the data were analyzed using Statistical Package for Social Sciences (SPSS version 16.0, SPSS, Chicago, IL) software.
RESULT


Both therapies resulted in significant improvements. Mean reduction in GI from baseline to 21 days was 1.20±0.41 and 0.73±0.45 in group 1 and group 2, respectively. Plaque Index also improved through the study period in both groups, i.e., 0.86±0.51 in group 1 and 1.6±0.97 in group 2. Mean PD reduced significantly with SRP plus AZM gel application in group 1, i.e., 2.1±0.91 mm as compared to 1.0±1.06 mm achieved with SRP alone. A significant gain in mean CAL gain was observed in the test group (1.8±0.63 mm) as compared to control group (1.0±1.06 mm).
CONCLUSION


Although both treatment strategies seem to benefit patients, the adjunctive use of 0.5% of AZM showed significant results.",2011,"A significant gain in mean CAL gain was observed in the test group (1.8±0.63 mm) as compared to control group (1.0±1.06 mm).
","['Thirty sites in patients with chronic periodontitis and probing depth (PD) 4-6 mm', 'chronic periodontitis']","['Scaling and root planing (SRP) plus 0.5% AZM gel (group 1) and SRP', 'Azithromycin (AZM', 'azithromycin gel', 'AZM']","['Mean PD', 'Plaque Index', 'mean CAL gain', 'Gingival Index (GI) of Loe and Silness and plaque', 'Pocket PD and clinical attachment level (CAL', 'Mean reduction in GI']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0266929', 'cui_str': 'Adult Periodontitis'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}]","[{'cui': 'C0085287', 'cui_str': 'Root Planings'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0017569', 'cui_str': 'Gingival Index'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0263264,"A significant gain in mean CAL gain was observed in the test group (1.8±0.63 mm) as compared to control group (1.0±1.06 mm).
","[{'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Tyagi', 'Affiliation': 'Department of Periodontology and Implantology,I.T.S. Centre for Dental Studies and Research, Muradnagar, Ghaziabad, Uttar Pradesh, India.'}, {'ForeName': 'Shubhra', 'Initials': 'S', 'LastName': 'Vaish', 'Affiliation': ''}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Dodwad', 'Affiliation': ''}]",Indian journal of medical sciences,['10.4103/0019-5359.107017']
1703,32035854,Randomized Trial of a Virtual Reality Tool to Teach Surgical Technique for Tibial Shaft Fracture Intramedullary Nailing.,"INTRODUCTION


Active learning methods have accumulated popularity due to improved results in knowledge acquisition as opposed to passive learning methods. For surgical resident physicians with limited training opportunities outside of the operating room due to time constraints, virtual reality (VR) is a relatively inexpensive and time-efficient active training method for procurement of surgical skills. We conducted a simulated intramedullary nailing (IMN) of a tibia to demonstrate VR training programs as a more effective modality of learning orthopedic surgical techniques compared to passive learning tools such as a standard guide (SG) through trained novice medical students performing a SawBones simulation of intramedullary nail fixation.
MATERIALS AND METHODS


First and second-year medical students without prior experience of procedure were recruited and randomized to SG or VR training. Participants were observed performing simulated tibia IMN procedure immediately after training and evaluated by a blinded attending surgeon using procedure-specific checklist and 5-point global assessment scale. Participants returned after 2-weeks for repeat training and evaluation.
RESULTS


20 participants were recruited and randomized into VR (n = 10) and SG (n = 10) groups. All 20 participants completed the first phase and 17 completed the second phase of the study. Aggregate global assessment scores were significantly higher for VR than SG group (17.5 vs. 7.5, p < 0.001), including scores in all individual categories. The percentage of steps completed correctly was significantly higher in the VR group compared to the SG group (63% vs. 25%, p < 0.002). Average improvement between the first and second phases of the study were higher in the VR group compared to SG group across all 5-categories of the global assessment scale, and significantly higher for knowledge of instruments (50% vs. 11%, p, 0.01).
DISCUSSION


VR training was more effective than a passive SG in our model of simulated tibia IMN for novice medical students. Virtual reality training may be a useful method to augment orthopedic education.",2020,"Average improvement between the first and second phases of the study were higher in the VR group compared to SG group across all 5-categories of the global assessment scale, and significantly higher for knowledge of instruments (50% vs. 11%, p, 0.01).
","['20 participants', 'novice medical students', 'trained novice medical students performing a SawBones simulation of intramedullary nail fixation', 'All 20 participants completed the first phase and 17 completed the second phase of the study', 'First and second-year medical students without prior experience of procedure', 'Tibial Shaft Fracture Intramedullary Nailing']","['VR training', 'Virtual Reality Tool to Teach Surgical Technique', 'simulated intramedullary nailing (IMN) of a tibia to demonstrate VR training programs', 'Virtual reality training', 'SG or VR training', 'SG']","['Aggregate global assessment scores', 'percentage of steps completed correctly']","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0336581', 'cui_str': 'Intramedullary rod, device (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0337141', 'cui_str': 'Shaft (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0021885', 'cui_str': 'Intramedullary Nailing'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0021885', 'cui_str': 'Intramedullary Nailing'}, {'cui': 'C0040184', 'cui_str': 'Tibia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205418', 'cui_str': 'Aggregate (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",20.0,0.0186146,"Average improvement between the first and second phases of the study were higher in the VR group compared to SG group across all 5-categories of the global assessment scale, and significantly higher for knowledge of instruments (50% vs. 11%, p, 0.01).
","[{'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'Blumstein', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California. Electronic address: gblumstein@mednet.ucla.edu.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zukotynski', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Cevallos', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Ishmael', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Zoller', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Zach', 'Initials': 'Z', 'LastName': 'Burke', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Clarkson', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Bernthal', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Nelson F', 'Initials': 'NF', 'LastName': 'SooHoo', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.01.002']
1704,23364504,Effect of multimodality chest physiotherapy on the rate of recovery and prevention of complications in patients with mechanical ventilation: a prospective study in medical and surgical intensive care units.,"BACKGROUND


Mechanically ventilated patients have an increased risk of complications leading to ventilation weaning more difficult resulting in excessive morbidity and mortality. Chest physiotherapy plays an important role in management of ventilated patients. However, these techniques have been studied on patients as a single entity or with combination of two techniques. The present study was designed to evaluate the effect of multimodality chest physiotherapy on the rate of recovery and prevention of complications in adult ventilated patients.
MATERIALS AND METHODS


Out of 173 patients who were randomly allocated to two groups, 86 patients received MH and suctioning in control group and 87 patients were treated with multimodality chest physiotherapy in the study group twice daily till they were extubated. All patients were followed up for the global outcomes and complications during mechanical ventilation.
RESULTS


There were significant improvements in terms of rate of recovery in study group compared to the control group (P = 0.000). Complication rates were higher with 61.6% in the control group as compared to 26.4% in the study group. Duration of hospitalization was longer in the study group (16 ± 9.40 days) as compared to the control group (12.8 ± 6.12 days). Successful weaning from mechanical ventilation was noted in 58 patients in the study group and 24 patients in the control group which was statistically significant.
CONCLUSIONS


Multi-modality chest physiotherapy protocol has shown to prevent ventilator-associated pneumonia and enhance the clinical outcome in ventilated patients and may be recommended as a treatment option in ICU. It has also shown to enhance the weaning process and proved to be safe.",2011,Duration of hospitalization was longer in the study group (16 ± 9.40 days) as compared to the control group (12.8 ± 6.12 days).,"['Out of 173 patients who were randomly allocated to two groups, 86 patients received', 'group and 87 patients were treated with', 'adult ventilated patients', 'patients with mechanical ventilation', 'ventilated patients']","['multimodality chest physiotherapy', 'Chest physiotherapy', 'MH and suctioning in control']","['Successful weaning from mechanical ventilation', 'Complication rates', 'Duration of hospitalization', 'rate of recovery', 'rate of recovery and prevention of complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}]","[{'cui': 'C0199467', 'cui_str': 'Physiotherapy of chest (regime/therapy)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]",173.0,0.0714612,Duration of hospitalization was longer in the study group (16 ± 9.40 days) as compared to the control group (12.8 ± 6.12 days).,"[{'ForeName': 'Renu B', 'Initials': 'RB', 'LastName': 'Pattanshetty', 'Affiliation': 'Department of Cardio-respiratory physiotherapy, KLEU Institute of Physiotherapy, JN Medical College, Nehru Nagar, Belgaum, Karnataka, India. renu_kori@rediffmail.com'}, {'ForeName': 'Gajanan S', 'Initials': 'GS', 'LastName': 'Gaude', 'Affiliation': ''}]",Indian journal of medical sciences,['10.4103/0019-5359.106608']
1705,23364505,Are we ignoring diabetic disability: a cross sectional study of diabetic myopathy.,"BACKGROUND


The complications associated with type 2 Diabetes Mellitus (DM) may cause functional impairment in older people. Recently it has been proved that motor dysfunction in the form of skeletal muscle dysfunction does occur in type II DM. However very few studies have assessed the upper limb skeletal muscle dysfunction.
OBJECTIVES


The study was aimed to assess the hand grip strength, endurance in type 2 DM patients and compare the same with age matched healthy controls. We also correlated glycosylated Hb and duration of illness with the hand grip strength and endurance in the patients.
MATERIALS AND METHODS


Hand grip dynamometer was used to measure the hand grip strength and endurance in sixty diagnosed patients of type II DM. Similar tests were performed in age matched healthy controls. Blood samples were collected for blood glucose fasting, postprandial levels and Hb1AC in both the groups. Comparisons between patients and controls, and correlations were done by applying suitable tests.
RESULTS


The hand grip muscle strength and endurance in type II DM patients were significantly lower as compared to the normal controls (P < 0.05, P < 0.001). There was no correlation between the hand grip muscle strength and endurance with HbA1c and the duration of the disease in the patients of type II DM (P > 0.05).
CONCLUSIONS


The present study shows that type II DM patients suffer from skeletal muscle dysfunction in the form of reduced hand grip strength and endurance. Hence the treating Physician should not be ignorant about these disabilities. In addition to the strict measures to control the blood glucose levels, interventions to improve the muscle mass and strength in these patients should be undertaken.",2011,"The hand grip muscle strength and endurance in type II DM patients were significantly lower as compared to the normal controls (P < 0.05, P < 0.001).","['age matched healthy controls', 'type 2 DM patients and compare the same with age matched healthy controls', 'older people', 'sixty diagnosed patients of type II DM']",[],"['hand grip muscle strength and endurance', 'hand grip muscle strength and endurance with HbA1c and the duration of the disease', 'blood glucose fasting, postprandial levels and Hb1AC']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]",[],"[{'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",60.0,0.0205891,"The hand grip muscle strength and endurance in type II DM patients were significantly lower as compared to the normal controls (P < 0.05, P < 0.001).","[{'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Department of Physiology, B. J. Medical College, Pune, Maharashtra, India.'}, {'ForeName': 'Pranali', 'Initials': 'P', 'LastName': 'Sonawane', 'Affiliation': ''}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Nahar', 'Affiliation': ''}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Buge', 'Affiliation': ''}, {'ForeName': 'Savita', 'Initials': 'S', 'LastName': 'Vaidya', 'Affiliation': ''}]",Indian journal of medical sciences,['10.4103/0019-5359.106609']
1706,22945779,Sublingual misoprostol: a better choice for cervical priming before manual vacuum aspiration.,"BACKGROUND


Misoprostol is effective for cervical priming before manual vacuum aspiration (MVA). Aim of study was to determine whether sublingual misoprostol with a shorter interval of 2 hours before MVA would be as effective as its standard vaginal administration.
STUDY DESIGN


This randomized control trial included 82 women randomly assigned to receive 400 mcg of misoprostol, either sublingually or vaginally. MVA was performed 2 hours and 3 hours after in sublingual and vaginal group, respectively.
RESULTS


Cervical dilatation of 8 mm was achieved within 2 hours in sublingual group. Mean time taken for procedure (14.4 ± 5.3: sublingual group and 16.2 ± 5.7: vaginal group), and blood loss was comparable (12.2 ± 9.7 ml in sublingual group and 13.7 ± 8.5 ml in vaginal group).
CONCLUSION


2 hour of cervical priming with 400 mcg of sublingual misoprostol before MVA was as good as 3 hours with vaginal administration of the same dose.",2010,"Mean time taken for procedure (14.4 ± 5.3: sublingual group and 16.2 ± 5.7: vaginal group), and blood loss was comparable (12.2 ± 9.7 ml in sublingual group and 13.7 ± 8.5 ml in vaginal group).
","['82 women randomly assigned to receive 400 mcg of', 'cervical priming before manual vacuum aspiration']","['Misoprostol', 'sublingual misoprostol', 'misoprostol, either sublingually or vaginally', 'Sublingual misoprostol']","['Mean time taken for procedure', 'blood loss', 'MVA']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}]","[{'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C2939181', 'cui_str': 'Motor vehicle traffic accident (event)'}]",82.0,0.10153,"Mean time taken for procedure (14.4 ± 5.3: sublingual group and 16.2 ± 5.7: vaginal group), and blood loss was comparable (12.2 ± 9.7 ml in sublingual group and 13.7 ± 8.5 ml in vaginal group).
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Shetty', 'Affiliation': 'Department of OBG, Kasturba Medical College, Manipal, India. jthshetty@gmail.com'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Chawla', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Pandey', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kamath', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Guddattu', 'Affiliation': ''}]",Indian journal of medical sciences,['10.4103/0019-5359.100338']
1707,32070297,Effect of availability of HIV self-testing on HIV testing frequency among men who have sex with men attending university in China (UniTest): protocol of a stepped-wedge randomized controlled trial.,"BACKGROUND


HIV testing plays a central role in the combat against HIV. We aimed to determine if the availability of HIV self-testing (HIVST) would increase the frequency of testing among men who have sex with men (MSM) attending university in China.
METHODS


A stepped wedge randomized controlled trial will be conducted in 4 provinces in China: Chongqing, Guangdong, Shandong, and Tianjin. Eligibility assessment will include (1) male, aged 16 years or older, (2) university student (technical diploma and undergraduate students), (3) MSM (sexual behaviors including mutual masturbation, oral sex, and anal sex), (4) HIV negative, and (5) willing to provide informed consent. Participants will be randomly allocated to HIV self-testing intervention with free HIVST kits in every 30 days according to the intervention waiting lists with a computer-generated randomized sequence. All participants will complete a self-administrated online questionnaire onsite at baseline and 12-month follow-up and complete an online questionnaire at 4- and 8-month. The primary outcome is the effect of HIVST on HIV testing frequency. Secondary outcomes include the change in sexual behaviors and HIV incidence.
DISCUSSION


No previous study had measured the effect of social media based HIVST intervention on the change in HIV testing behaviors, sexual behaviors and incident HIV infection among MSM attending university in China. Findings from this study will provide evidence for further interventional practice promotions and prevention strategies scale-up, including HIV testing, pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), and sexual partner serosorting.
TRIAL REGISTRATION


Chinese Clinical Trial Registry: ChiCTR1900020645. Registered 11 January 2019.",2020,"No previous study had measured the effect of social media based HIVST intervention on the change in HIV testing behaviors, sexual behaviors and incident HIV infection among MSM attending university in China.","['1) male, aged 16\u2009years or older, (2) university student (technical diploma and undergraduate students), (3) MSM (sexual behaviors including mutual masturbation, oral sex, and anal sex), (4) HIV negative, and (5) willing to provide informed consent', '4 provinces in China: Chongqing, Guangdong, Shandong, and Tianjin', 'men who have sex with men attending university in China (UniTest', 'MSM attending university in China', 'men who have sex with men (MSM) attending university in China']","['HIV self-testing', 'social media based HIVST intervention', 'HIV self-testing intervention with free HIVST kits', 'HIV self-testing (HIVST']","['change in sexual behaviors and HIV incidence', 'HIV testing frequency', 'effect of HIVST on HIV testing frequency', 'HIV testing behaviors, sexual behaviors and incident HIV infection']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0556633', 'cui_str': 'Mutual masturbation (finding)'}, {'cui': 'C0282348', 'cui_str': 'Oral Sex'}, {'cui': 'C0282347', 'cui_str': 'Anal Sex'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0557300', 'cui_str': 'Attending university (finding)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1690540', 'cui_str': 'Kit'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}]",1.0,0.161076,"No previous study had measured the effect of social media based HIVST intervention on the change in HIV testing behaviors, sexual behaviors and incident HIV infection among MSM attending university in China.","[{'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': 'School of Public Health, Sun Yat-sen University, Guangzhou, 510080, Guangdong, China.'}, {'ForeName': 'Zhongquan', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of AIDS/STD Control and Prevention, Tianjin Center for Disease Control and Prevention, Tianjin, 300011, China.'}, {'ForeName': 'Zhenzhou', 'Initials': 'Z', 'LastName': 'Luo', 'Affiliation': 'Nanshan District Center for Chronic Disease Control, Shenzhen, 518000, China.'}, {'ForeName': 'Maohe', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Department of AIDS/STD Control and Prevention, Tianjin Center for Disease Control and Prevention, Tianjin, 300011, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Ouyang', 'Affiliation': 'Department of AIDS/STD Control and Prevention, Chongqing Center for Disease Control and Prevention, Chongqing, 400042, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Gong', 'Affiliation': 'Department of AIDS/STD Control and Prevention, Tianjin Center for Disease Control and Prevention, Tianjin, 300011, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Nanshan District Center for Chronic Disease Control, Shenzhen, 518000, China.'}, {'ForeName': 'Peiyang', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'School of Public Health, Sun Yat-sen University, Guangzhou, 510080, Guangdong, China.'}, {'ForeName': 'Tanwei', 'Initials': 'T', 'LastName': 'Yuan', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-sen University, Shenzhen, 510006, Guangdong, China.'}, {'ForeName': 'Yepeng', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Foshan Pengyou AIDS Prevention Care Center, Foshan, 528000, Guangdong, China.'}, {'ForeName': 'Guohui', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Department of AIDS/STD Control and Prevention, Chongqing Center for Disease Control and Prevention, Chongqing, 400042, China. cqwuguohui@qq.com.'}, {'ForeName': 'Huachun', 'Initials': 'H', 'LastName': 'Zou', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-sen University, Shenzhen, 510006, Guangdong, China. zouhuachun@mail.sysu.edu.cn.'}]",BMC infectious diseases,['10.1186/s12879-020-4807-4']
1708,31255307,Effects of Different Frequencies of Whole Body Vibration on Repositioning Error in Patients With Chronic Low Back Pain in Different Angles of Lumbar Flexion.,"OBJECTIVE


This study aimed to evaluate the effect of high and low frequency of whole body vibration (WBV) on repositioning error in 3 different angles of lumbar flexion in patients with chronic low back pain.
METHODS


Twenty-four participants with chronic low back pain, aged between 20 and 35 years, were included in this randomized crossover trial study. Participants were randomly assigned into 2 groups as follows: (1) low frequency/high frequency, and (2) high frequency/low frequency. Participants received high-frequency (50 Hz) and low-frequency (30 Hz) WBV in a semi-squat position for 5 minutes in 2 sessions, with 2 weeks of rest. Before and after the WBV, lumbar repositioning error in 30% and 60% of lumbar full flexion and neutral position with eyes closed when standing was evaluated using an electrogoniometer.
RESULTS


The repositioning error was decreased in neutral, 30%, and 60% of lumbar flexion after the low-frequency and high-frequency WBV. Post hoc testing revealed that the effect of angle was not significant in repositioning error changes between high-frequency and low-frequency WBV (P > .05). However, the effect of low-frequency WBV on the repositioning error was significantly higher compared with high-frequency WBV (P < .05).
CONCLUSION


Low-frequency WBV might induce more improvement in the accuracy of lumbopelvic repositioning compared with high-frequency WBV with the method of WBV used in this study.",2019,Low-frequency WBV might induce more improvement in the accuracy of lumbopelvic repositioning compared with high-frequency WBV with the method of WBV used in this study.,"['patients with chronic low back pain', 'Patients With Chronic Low Back Pain in Different Angles of Lumbar Flexion', 'Twenty-four participants with chronic low back pain, aged between 20 and 35 years']","['Different Frequencies of Whole Body Vibration', 'high and low frequency of whole body vibration (WBV']","['lumbar repositioning error', 'repositioning error']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0556030', 'cui_str': 'Repositioning (procedure)'}]",24.0,0.0536008,Low-frequency WBV might induce more improvement in the accuracy of lumbopelvic repositioning compared with high-frequency WBV with the method of WBV used in this study.,"[{'ForeName': 'Nashmin', 'Initials': 'N', 'LastName': 'Sajadi', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences and Health Services, Tehran, Iran.'}, {'ForeName': 'Rasool', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Amiri', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences and Health Services, Tehran, Iran. Electronic address: ali.amiript@yahoo.com.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Maroufi', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences and Health Services, Tehran, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Shadmehr', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences and Health Services, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Pourahmadi', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences and Health Services, Tehran, Iran.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2018.11.006']
1709,31335570,"Safety and Efficacy of Ceftazidime-Avibactam in the Treatment of Children ≥3 Months to <18 Years With Complicated Urinary Tract Infection: Results from a Phase 2 Randomized, Controlled Trial.","BACKGROUND


Ceftazidime-avibactam is effective and well tolerated in adults with complicated urinary tract infection (cUTI), but has not been evaluated in children with cUTI.
METHODS


This single-blind, multicenter, active-controlled, phase 2 study (NCT02497781) randomized children ≥3 months to <18 years with cUTI (3:1) to receive intravenous (IV) ceftazidime-avibactam or cefepime for ≥72 hours, with subsequent optional oral switch. Total treatment duration was 7-14 days. Primary objective was assessment of safety. Secondary objectives included descriptive efficacy and pharmacokinetics. A blinded observer determined adverse event (AE) causality and clinical outcomes up to the late follow-up visit (20-36 days after the last dose of IV/oral therapy).
RESULTS


In total, 95 children received ≥1 dose of IV study drug (ceftazidime-avibactam, n = 67; cefepime, n = 28). The predominant baseline Gram-negative uropathogen was Escherichia coli (92.2%). AEs occurred in 53.7% and 53.6% patients in the ceftazidime-avibactam and cefepime groups, respectively. Serious AEs occurred in 11.9% (ceftazidime-avibactam) and 7.1% (cefepime) patients. One serious AE (ceftazidime-avibactam group) was considered drug related. In the microbiologic intent-to-treat analysis set, favorable clinical response rates >95% were observed for both groups at end-of-IV and remained 88.9% (ceftazidime-avibactam) and 82.6% (cefepime) at test-of-cure. Favorable per-patient microbiologic response at test-of-cure was 79.6% (ceftazidime-avibactam) and 60.9% (cefepime).
CONCLUSIONS


Ceftazidime-avibactam was well tolerated in children with cUTI, with a safety profile consistent with that of adults with cUTI and of ceftazidime alone, and appeared effective in children with cUTI due to Gram-negative pathogens.",2019,Serious AEs occurred in 11.9% (ceftazidime-avibactam) and 7.1% (cefepime) patients.,"['children with cUTI', 'children ≥3 months to <18 years with cUTI (3:1) to receive', 'adults with complicated urinary tract infection (cUTI', 'Children ≥3 Months to <18 Years With Complicated Urinary Tract Infection']","['Ceftazidime-Avibactam', 'intravenous (IV) ceftazidime-avibactam or cefepime', 'ceftazidime', 'Ceftazidime-avibactam']","['adverse event (AE) causality and clinical outcomes', 'Total treatment duration', 'Serious AEs', 'Favorable per-patient microbiologic response', 'AEs', 'descriptive efficacy and pharmacokinetics', 'Safety and Efficacy', 'clinical response rates']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4552431', 'cui_str': 'Complicated urinary tract infection'}]","[{'cui': 'C3656596', 'cui_str': 'avibactam / Ceftazidime'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0055003', 'cui_str': 'cefepime'}, {'cui': 'C0007559', 'cui_str': 'Ceftazidime'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015127', 'cui_str': 'causes'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",95.0,0.17366,Serious AEs occurred in 11.9% (ceftazidime-avibactam) and 7.1% (cefepime) patients.,"[{'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Bradley', 'Affiliation': ''}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Roilides', 'Affiliation': '3rd Department of Pediatrics, Aristotle University School of Health Sciences, Hippokration Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Broadhurst', 'Affiliation': 'AstraZeneca, Alderley Park, Cheshire, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Cheng', 'Affiliation': 'Pfizer, Sandwich, Kent, United Kingdom.'}, {'ForeName': 'Li-Min', 'Initials': 'LM', 'LastName': 'Huang', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'MasCasullo', 'Affiliation': 'Allergan plc, Madison, NJ.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Newell', 'Affiliation': 'AstraZeneca, Alderley Park, Cheshire, United Kingdom.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Stone', 'Affiliation': 'Pfizer, Groton, CT.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Tawadrous', 'Affiliation': 'Pfizer, Groton, CT.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Wajsbrot', 'Affiliation': 'Pfizer, New York, NY.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Yates', 'Affiliation': 'AstraZeneca, Alderley Park, Cheshire, United Kingdom.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Gardner', 'Affiliation': 'Pfizer, Cambridge, MA.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002395']
1710,31540867,"Efficacy and safety of once-weekly semaglutide versus daily canagliflozin as add-on to metformin in patients with type 2 diabetes (SUSTAIN 8): a double-blind, phase 3b, randomised controlled trial.","BACKGROUND


Existing guidelines for management of type 2 diabetes recommend a patient-centred approach to guide the choice of pharmacological agents. Although glucagon-like peptide-1 (GLP-1) receptor agonists and sodium-glucose cotransporter-2 (SGLT2) inhibitors are increasingly used as second-line agents, direct comparisons between these treatments are insufficient. In the SUSTAIN 8 trial, we compared the efficacy and safety of semaglutide (a GLP-1 receptor agonist) with canagliflozin (an SGLT2 inhibitor) in patients with type 2 diabetes.
METHODS


This was a double-blind, parallel-group, phase 3b, randomised controlled trial done at 111 centres in 11 countries. Eligible patients were at least 18 years old and had uncontrolled type 2 diabetes (HbA 1c  7·0-10·5% [53-91 mmol/mol]) on stable daily metformin therapy. Patients were randomly assigned (1:1) by use of an interactive web response system to subcutaneous semaglutide 1·0 mg once weekly or oral canagliflozin 300 mg once daily. The primary endpoint was change from baseline in HbA 1c , and the confirmatory secondary endpoint was change from baseline in bodyweight, both at week 52. The primary analysis population included all randomly assigned patients, using on-treatment data collected before initiation of rescue medication. The safety analysis was done on a population that included all patients exposed to at least one dose of trial product. The trial was powered for HbA 1c  and bodyweight superiority under reasonable assumptions. This trial is registered with ClinicalTrials.gov, NCT03136484.
FINDINGS


Between March 15, 2017, and Nov 16, 2018, 788 patients were randomly assigned to semaglutide 1·0 mg (394 patients) or canagliflozin 300 mg (394 patients). 739 patients completed the trial (367 in the semaglutide group and 372 in the canagliflozin group). From overall baseline mean, patients receiving semaglutide had significantly greater reductions in HbA 1c  and bodyweight than those receiving canagliflozin (HbA 1c  estimated treatment difference [ETD] -0·49 percentage points, 95% CI -0·65 to -0·33; -5·34 mmol/mol, 95% CI -7·10 to -3·57; p<0·0001; and bodyweight ETD -1·06 kg, 95% CI -1·76 to -0·36; p=0·0029). Gastrointestinal disorders, most commonly nausea, were the most frequently reported adverse events with semaglutide, occurring in 184 (47%) of 392 patients; whereas infections and infestations (defined using the Medical Dictionary for Regulatory Activities, version 21.0), most commonly urinary tract infections, occurred more frequently with canagliflozin, in 136 (35%) of 394 patients. Premature treatment discontinuation because of adverse events occurred in 38 (10%) of 392 patients with semaglutide and in 20 (5%) of 394 patients with canagliflozin. One fatal adverse event confirmed unlikely to be caused by treatment occurred in the semaglutide group.
INTERPRETATION


Once-weekly semaglutide 1·0 mg was superior to daily canagliflozin 300 mg in reducing HbA 1c  and bodyweight in patients with type 2 diabetes uncontrolled on metformin therapy. These outcomes might guide treatment intensification choices.
FUNDING


Novo Nordisk.",2019,Premature treatment discontinuation because of adverse events occurred in 38 (10%) of 392 patients with semaglutide and in 20 (5%) of 394 patients with canagliflozin.,"['739 patients completed the trial (367 in the semaglutide group and 372 in the canagliflozin group', 'patients with type 2 diabetes uncontrolled on', '111 centres in 11 countries', 'Between March 15, 2017, and Nov 16, 2018, 788 patients', 'Eligible patients were at least 18 years old and had uncontrolled type 2 diabetes (HbA 1c  7·0', '392 patients with semaglutide and in 20 (5%) of 394 patients with canagliflozin', 'patients with type 2 diabetes']","['canagliflozin 300 mg in reducing HbA 1c  and bodyweight', 'canagliflozin (an SGLT2 inhibitor', 'once-weekly semaglutide versus daily canagliflozin', 'canagliflozin', 'metformin', 'metformin therapy', 'interactive web response system to subcutaneous semaglutide 1·0 mg once weekly or oral canagliflozin 300 mg once daily', 'glucagon-like peptide-1 (GLP-1) receptor agonists and sodium-glucose cotransporter-2 (SGLT2) inhibitors']","['change from baseline in HbA 1c', 'HbA 1c  and bodyweight', 'adverse events', 'Efficacy and safety', 'efficacy and safety of semaglutide', 'infections and infestations', 'Gastrointestinal disorders']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled (qualifier value)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]","[{'cui': 'C3556568', 'cui_str': 'canagliflozin 300 MG [Invokana]'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C4543206', 'cui_str': 'Receptor agonist (disposition)'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0009450', 'cui_str': 'Infectious Diseases'}, {'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}]",739.0,0.357426,Premature treatment discontinuation because of adverse events occurred in 38 (10%) of 392 patients with semaglutide and in 20 (5%) of 394 patients with canagliflozin.,"[{'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'Department of Internal Medicine/Endocrinology, Department of Clinical Sciences, UT Southwestern Medical Center, University of Texas, Dallas, TX, USA. Electronic address: ildiko.lingvay@UTSouthwestern.edu.'}, {'ForeName': 'Andrei-Mircea', 'Initials': 'AM', 'LastName': 'Catarig', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Kumar', 'Affiliation': 'Centre for Endocrinology and Diabetes, Amrita Hospital, Kochi, India.'}, {'ForeName': 'Nanna L', 'Initials': 'NL', 'LastName': 'Lausvig', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Carel W', 'Initials': 'CW', 'LastName': 'le Roux', 'Affiliation': 'Diabetes Complications Research Centre, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Desirée', 'Initials': 'D', 'LastName': 'Thielke', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Adie', 'Initials': 'A', 'LastName': 'Viljoen', 'Affiliation': 'Borthwick Diabetes Research Centre, Stevenage, UK.'}, {'ForeName': 'Rory J', 'Initials': 'RJ', 'LastName': 'McCrimmon', 'Affiliation': 'School of Medicine, University of Dundee, Dundee, UK.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30311-0']
1711,31843251,Quality of life after pharmacomechanical catheter-directed thrombolysis for proximal deep venous thrombosis.,"BACKGROUND


After deep venous thrombosis (DVT), many patients have impaired quality of life (QOL). We aimed to assess whether pharmacomechanical catheter-directed thrombolysis (PCDT) improves short-term or long-term QOL in patients with proximal DVT and whether QOL is related to extent of DVT.
METHODS


The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial was an assessor-blinded randomized trial that compared PCDT with no PCDT in patients with DVT of the femoral, common femoral, or iliac veins. QOL was assessed at baseline and 1 month, 6 months, 12 months, 18 months, and 24 months using the Venous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym) disease-specific QOL measure and the 36-Item Short Form Health Survey (SF-36) physical component summary (PCS) and mental component summary general QOL measures. Change in QOL scores from baseline to assessment time were compared in the PCDT and no PCDT treatment groups overall and in the iliofemoral DVT and femoral-popliteal DVT subgroups.
RESULTS


Of 692 ATTRACT patients, 691 were analyzed (mean age, 53 years; 62% male; 57% iliofemoral DVT). VEINES-QOL change scores were greater (ie, better) in PCDT vs no PCDT from baseline to 1 month (difference, 5.7; P = .0006) and from baseline to 6 months (5.1; P = .0029) but not for other intervals. SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 2.4; P = .01) but not for other intervals. Among iliofemoral DVT patients, VEINES-QOL change scores from baseline to all assessments were greater in the PCDT vs no PCDT group; this was statistically significant in the intention-to-treat analysis at 1 month (difference, 10.0; P < .0001) and 6 months (8.8; P < .0001) and in the per-protocol analysis at 18 months (difference, 5.8; P = .0086) and 24 months (difference, 6.6; P = .0067). SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 3.2; P = .0010) but not for other intervals. In contrast, in femoral-popliteal DVT patients, change scores from baseline to all assessments were similar in the PCDT and no PCDT groups.
CONCLUSIONS


Among patients with proximal DVT, PCDT leads to greater improvement in disease-specific QOL than no PCDT at 1 month and 6 months but not later. In patients with iliofemoral DVT, PCDT led to greater improvement in disease-specific QOL during 24 months.",2020,"Among patients with proximal DVT, PCDT leads to greater improvement in disease-specific QOL than no PCDT at 1 month and 6 months but not later.","['patients with DVT of the femoral, common femoral, or iliac veins', 'proximal deep venous thrombosis', 'Of 692 ATTRACT patients, 691 were analyzed (mean age', '53\xa0years; 62% male; 57% iliofemoral DVT', 'patients with proximal DVT and whether QOL']","['PCDT with no PCDT', 'pharmacomechanical catheter-directed thrombolysis', 'pharmacomechanical catheter-directed thrombolysis (PCDT', 'PCDT']","['QOL scores', 'disease-specific QOL', 'Quality of life', 'VEINES-QOL change scores', 'Quality of Life/Symptoms (VEINES-QOL/Sym) disease-specific QOL measure and the 36-Item Short Form Health Survey (SF-36) physical component summary (PCS) and mental component summary general QOL measures', 'SF-36 PCS change scores', 'QOL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0020888', 'cui_str': 'Iliac Vein'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",691.0,0.105402,"Among patients with proximal DVT, PCDT leads to greater improvement in disease-specific QOL than no PCDT at 1 month and 6 months but not later.","[{'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Kahn', 'Affiliation': 'Center for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montreal, Quebec, Canada. Electronic address: susan.kahn@mcgill.ca.'}, {'ForeName': 'Jim A', 'Initials': 'JA', 'LastName': 'Julian', 'Affiliation': 'Department of Oncology, McMaster University, Hamilton, Ontario, Canada; Juravinski Hospital and Cancer Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Kearon', 'Affiliation': 'Juravinski Hospital and Cancer Centre, Hamilton, Ontario, Canada; Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Chu-Shu', 'Initials': 'CS', 'LastName': 'Gu', 'Affiliation': 'Department of Oncology, McMaster University, Hamilton, Ontario, Canada; Juravinski Hospital and Cancer Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': ""Department of Medicine, University of Missouri-Kansas City, Kansas City, Mo; St. Luke's Mid America Heart Institute, Kansas City, Mo.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Magnuson', 'Affiliation': ""St. Luke's Mid America Heart Institute, Kansas City, Mo.""}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Comerota', 'Affiliation': 'Inova Heart and Vascular Institute, Inova Alexandria Hospital, Alexandria, Va.'}, {'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Goldhaber', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Mass; Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jaff', 'Affiliation': 'Harvard Medical School, Boston, Mass; Newton-Wellesley Hospital, Newton, Mass.'}, {'ForeName': 'Mahmood K', 'Initials': 'MK', 'LastName': 'Razavi', 'Affiliation': ""St. Joseph's Hospital, Orange, Calif.""}, {'ForeName': 'Andrei L', 'Initials': 'AL', 'LastName': 'Kindzelski', 'Affiliation': 'Division of Blood Diseases and Resources, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Md.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Schneider', 'Affiliation': 'Vascular Surgery and Interventional Radiology Partners/VSIR, Northwestern Medicine, Chicago, Ill.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Maine Medical Center, Portland, Me.'}, {'ForeName': 'Rabih', 'Initials': 'R', 'LastName': 'Chaer', 'Affiliation': 'Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa.'}, {'ForeName': 'Akhilesh K', 'Initials': 'AK', 'LastName': 'Sista', 'Affiliation': 'Department of Radiology, New York University, New York, NY.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'McLafferty', 'Affiliation': 'Department of Surgery, Portland Veterans Administration, Portland, Me.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Kaufman', 'Affiliation': 'Department of Interventional Radiology, Dotter Interventional Institute, Oregon Health & Science University, Portland.'}, {'ForeName': 'Brandt C', 'Initials': 'BC', 'LastName': 'Wible', 'Affiliation': ""Department of Radiology, St. Luke's Hospital, Kansas City, Mo.""}, {'ForeName': 'Morey', 'Initials': 'M', 'LastName': 'Blinder', 'Affiliation': 'Department of Medicine, Washington University in St. Louis, St. Louis, Mo.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Vedantham', 'Affiliation': 'Mallinckrodt Institute of Radiology, Washington University in St. Louis, St. Louis, Mo.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2019.03.023']
1712,32109179,"The Effects of Bioavailable Curcumin (Cureit) on Delayed Onset Muscle Soreness Induced By Eccentric Continuous Exercise: A Randomized, Placebo-Controlled, Double-Blind Clinical Study.","Delayed onset muscle soreness (DOMS) is a multifactorial progression related to muscle pain, swelling, stiffness, tenderness, altered joint kinematics, muscle fiber disruption, decreased strength and power, and acute tissue damage. Curcumin, a natural phytonutrient, could manage DOMS induced by eccentric continuous exercise due to its wide range of biological activities. This study was a randomized, placebo-controlled, double-blind clinical study to assess the efficacy of Cureit™-a bioavailable form of curcumin that may decrease damage from inflammation and oxidative stress associated with severe muscle damage induced by continuous eccentric exercise. The results of the study showed that oral consumption of Cureit significantly reduced DOMS, slightly reduced creatinine kinase concentrations, and slightly increased VO 2  max value compared with placebo, and found safe for administration. The consumption of Cureit led to improved recovery and reduction of DOMS without any side effects due to the enhancement of bioavailable form of curcumin.",2020,"The results of the study showed that oral consumption of Cureit significantly reduced DOMS, slightly reduced creatinine kinase concentrations, and slightly increased VO 2  max value compared with placebo, and found safe for administration.",['Delayed Onset Muscle Soreness Induced By Eccentric Continuous Exercise'],"['placebo', 'Bioavailable Curcumin (Cureit', 'Placebo']","['strength and power, and acute tissue damage', 'creatinine kinase concentrations', 'DOMS', 'Delayed onset muscle soreness (DOMS']","[{'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0935763', 'cui_str': 'Bioavailable'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}]","[{'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C4521566', 'cui_str': 'Kinase'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0013007', 'cui_str': '1-(2,5-Dimethoxy-4-Methylphenyl)-2-Aminopropane'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}]",,0.244405,"The results of the study showed that oral consumption of Cureit significantly reduced DOMS, slightly reduced creatinine kinase concentrations, and slightly increased VO 2  max value compared with placebo, and found safe for administration.","[{'ForeName': 'Augustine', 'Initials': 'A', 'LastName': 'Amalraj', 'Affiliation': 'R&D Centre, Aurea Biolabs Private Limited, Kolenchery, Cochin, Kerala, India.'}, {'ForeName': 'Chandradhara', 'Initials': 'C', 'LastName': 'Divya', 'Affiliation': 'BioAgile Therapeutics Private Limited, Bangalore, Karnataka, India.'}, {'ForeName': 'Sreeraj', 'Initials': 'S', 'LastName': 'Gopi', 'Affiliation': 'R&D Centre, Aurea Biolabs Private Limited, Kolenchery, Cochin, Kerala, India.'}]",Journal of medicinal food,['10.1089/jmf.2019.4533']
1713,22885319,Comparison of ramosetron and ondansetron for control of post-operative nausea and vomiting following laparoscopic cholecystectomy.,"BACKGROUND


Post-operative nausea and vomiting (PONV) is common. 5HT 3 receptor antagonists are commonly used drugs for its prevention. A study was designed to compare the efficacy and safety of ramosetron and ondansetron in patients undergoing laparoscopic cholecystectomy (lap chole).
MATERIALS AND METHODS


A prospective randomized case controlled study was conducted at J. N. Medical College Hospital, Aligarh Muslim University, Aligarh, India, in patients who underwent lap chole following intravenous administration of ondansetron (4mg) or ramosetron (0.3mg) at the end of surgery, and efficacy as well as side effects of ondansetron and ramosetron was documented and compared.
RESULTS


One hundred and thirty adult females undergoing lap chole were studied - 65 patients in each of the two groups. In first 24 h after surgery, complete response (No PONV) was observed in 28 patients of the ondansetron group and in 32 patients of the ramosetron group (P>0.05). Complete response in the second 24 h after surgery was observed in 30 patients of the ondansetron group and in 45 patients of the ramosetron group (P<0.05). During the first and second 24 h, PONV requiring rescue antiemetic was significantly higher (P<0.05) in the ondansetron group as compared to the ramosetron group. Adverse drug effects in the post-operative period were observed in 11 and 8 patients in ondansetron and ramosetron groups respectively (P>0.05).
CONCLUSION


Ramosetron was found safe and more effective antiemetic than ondansetron in patients undergoing lap chole.",2010,Ramosetron was found safe and more effective antiemetic than ondansetron in patients undergoing lap chole.,"['One hundred and thirty adult females undergoing lap chole were studied - 65 patients in each of the two groups', 'patients undergoing lap chole', 'control of post-operative nausea and vomiting following laparoscopic cholecystectomy', 'patients undergoing laparoscopic cholecystectomy (lap chole', 'at J. N. Medical College Hospital, Aligarh Muslim University, Aligarh, India, in patients who underwent lap chole following intravenous administration of']","['Ramosetron', 'ondansetron', 'ramosetron', 'ondansetron and ramosetron', 'ondansetron (4mg) or ramosetron', 'ramosetron and ondansetron']","['efficacy and safety', 'complete response (No PONV', 'PONV requiring rescue antiemetic', 'Adverse drug effects', 'Complete response']","[{'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0026870', 'cui_str': 'Muslims'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0013125'}]","[{'cui': 'C0526950', 'cui_str': 'ramosetron'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}]",130.0,0.0427895,Ramosetron was found safe and more effective antiemetic than ondansetron in patients undergoing lap chole.,"[{'ForeName': 'Maulana M', 'Initials': 'MM', 'LastName': 'Ansari', 'Affiliation': 'Department of Surgery, J.N.Medical college, Aligarh Muslim University, Uttar Pradesh, India.'}, {'ForeName': 'Obaid A', 'Initials': 'OA', 'LastName': 'Siddiqui', 'Affiliation': ''}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Haleem', 'Affiliation': ''}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Varshney', 'Affiliation': ''}, {'ForeName': 'Sadiq', 'Initials': 'S', 'LastName': 'Akhtar', 'Affiliation': ''}, {'ForeName': 'Faroze A', 'Initials': 'FA', 'LastName': 'Khan', 'Affiliation': ''}]",Indian journal of medical sciences,['10.4103/0019-5359.99606']
1714,22417252,Closure or medical therapy for cryptogenic stroke with patent foramen ovale.,"BACKGROUND


The prevalence of patent foramen ovale among patients with cryptogenic stroke is higher than that in the general population. Closure with a percutaneous device is often recommended in such patients, but it is not known whether this intervention reduces the risk of recurrent stroke.
METHODS


We conducted a multicenter, randomized, open-label trial of closure with a percutaneous device, as compared with medical therapy alone, in patients between 18 and 60 years of age who presented with a cryptogenic stroke or transient ischemic attack (TIA) and had a patent foramen ovale. The primary end point was a composite of stroke or transient ischemic attack during 2 years of follow-up, death from any cause during the first 30 days, or death from neurologic causes between 31 days and 2 years.
RESULTS


A total of 909 patients were enrolled in the trial. The cumulative incidence (Kaplan-Meier estimate) of the primary end point was 5.5% in the closure group (447 patients) as compared with 6.8% in the medical-therapy group (462 patients) (adjusted hazard ratio, 0.78; 95% confidence interval, 0.45 to 1.35; P=0.37). The respective rates were 2.9% and 3.1% for stroke (P=0.79) and 3.1% and 4.1% for TIA (P=0.44). No deaths occurred by 30 days in either group, and there were no deaths from neurologic causes during the 2-year follow-up period. A cause other than paradoxical embolism was usually apparent in patients with recurrent neurologic events.
CONCLUSIONS


In patients with cryptogenic stroke or TIA who had a patent foramen ovale, closure with a device did not offer a greater benefit than medical therapy alone for the prevention of recurrent stroke or TIA. (Funded by NMT Medical; ClinicalTrials.gov number, NCT00201461.).",2012,"No deaths occurred by 30 days in either group, and there were no deaths from neurologic causes during the 2-year follow-up period.","['patients with recurrent neurologic events', 'patients between 18 and 60 years of age who presented with a cryptogenic stroke or transient ischemic attack (TIA) and had a patent foramen ovale', '909 patients were enrolled in the trial', 'patients with cryptogenic stroke', 'cryptogenic stroke with patent foramen ovale', 'patients with cryptogenic stroke or TIA who had a patent foramen ovale']","['Closure or medical therapy', 'closure with a percutaneous device']","['cumulative incidence (Kaplan-Meier estimate', 'deaths', 'composite of stroke or transient ischemic attack during 2 years of follow-up, death from any cause during the first 30 days, or death from neurologic causes', 'respective rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin) (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0016522', 'cui_str': 'Patent Oval Foramen'}]","[{'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1720943', 'cui_str': 'Product-Limit Method'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}]",909.0,0.11547,"No deaths occurred by 30 days in either group, and there were no deaths from neurologic causes during the 2-year follow-up period.","[{'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Furlan', 'Affiliation': 'Department of Neurology, University Hospitals Case Medical Center, Cleveland, Ohio 44106, USA. anthony.furlan@uhhospitals.org'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Reisman', 'Affiliation': ''}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Massaro', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mauri', 'Affiliation': ''}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Adams', 'Affiliation': ''}, {'ForeName': 'Gregory W', 'Initials': 'GW', 'LastName': 'Albers', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Felberg', 'Affiliation': ''}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Herrmann', 'Affiliation': ''}, {'ForeName': 'Saibal', 'Initials': 'S', 'LastName': 'Kar', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Landzberg', 'Affiliation': ''}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Raizner', 'Affiliation': ''}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Wechsler', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1009639']
1715,31537259,Major Bleeding in Patients With Coronary or Peripheral Artery Disease Treated With Rivaroxaban Plus Aspirin.,"BACKGROUND


In patients with coronary or peripheral artery disease, the combination of rivaroxaban 2.5 mg twice daily and aspirin 100 mg once daily compared with aspirin 100 mg once daily reduced major adverse cardiovascular events and mortality and increased bleeding.
OBJECTIVES


This study sought to explore the effects of the combination of rivaroxaban and aspirin compared with aspirin on sites, timing, severity, and management of bleeding in the COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) study.
METHODS


This study reports, by treatment group, the number and proportion of patients; hazard rate ratios for bleeding according to site and severity; the timing of bleeding using landmark analyses; and the number and proportion of patients who received blood products and other hemostatic treatments.
RESULTS


Of 27,395 patients enrolled (mean age 68 years, 22% women), 18,278 were randomized to the combination of rivaroxaban and aspirin or to aspirin alone and followed for a mean of 23 months. Compared with aspirin alone, the combination increased modified International Society on Thrombosis and Hemostasis major bleeding (288 of 9,152 [3.1%] vs. 170 of 9,126 [1.9%]), (HR: 1.70; 95% CI: 1.40 to 2.05; p < 0.001), International Society on Thrombosis and Hemostasis major bleeding (206 of 9,152 [2.3%] vs. 116 of 9,126 [1.3%]), (HR: 1.78; 95% CI: 1.41 to 2.23; p < 0.0001), and minor bleeding (838 of 9,152 [9.2%] vs. 503 of 9,126 [5.5%]), (HR: 1.70; 95% CI 1.52 to 1.90; p < 0.0001); the combination also increased the need for any red cell transfusion (87 of 9,152 [1.0%] vs. 44 of 9,126 [0.5%]), (HR: 1.97; 95% CI 1.37 to 2.83, p = 0.0002). The gastrointestinal (GI) tract was the most common site of increased major bleeding (140 of 9,152 [1.5%] vs. 65 of 9,126 [0.7%]), (HR: 2.15; 95% CI: 1.60 to 2.89; p < 0.001), and the increase in bleeding was predominantly in the first year after randomization. Approximately one-third of major GI bleeding was gastric or duodenal, one-third was colonic or rectal, and one-third was from an unknown GI site. The study investigators reported that approximately three-quarters of major bleeding episodes were of mild or moderate intensity. A similar proportion of patients in each treatment group who experienced major bleeding received platelets, clotting factors, or other hemostatic agents.
CONCLUSIONS


The combination of rivaroxaban and aspirin compared with aspirin alone increased major bleeding, mainly from the GI tract. Most excess bleeding occurred during the first year after randomization, was of mild or moderate intensity, and was managed with conventional supportive therapy. (Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease [COMPASS]; NCT01776424).",2019,"Compared with aspirin alone, the combination increased modified International Society on Thrombosis and Hemostasis major bleeding (288 of 9,152 [3.1%] vs. 170 of 9,126 [1.9%]), (HR: 1.70; 95% CI: 1.40 to 2.05; p < 0.001), International Society on Thrombosis and Hemostasis major bleeding (206 of 9,152 [2.3%] vs. 116 of 9,126 [1.3%]), (HR: 1.78; 95% CI: 1.41 to 2.23; p < 0.0001), and minor bleeding (838 of 9,152 [9.2%] vs. 503 of 9,126 [5.5%]), (HR: 1.70; 95% CI 1.52 to 1.90; p < 0.0001); the combination also increased the need for any red cell transfusion (87 of 9,152 [1.0%] vs. 44 of 9,126 [0.5%]), (HR: 1.97; 95% CI 1.37 to 2.83, p = 0.0002).","['People Using Anticoagulation Strategies) study', 'Patients With Coronary\xa0or Peripheral Artery Disease', '27,395 patients enrolled (mean age 68 years, 22% women', 'patients with coronary or peripheral artery disease']","['rivaroxaban and aspirin', 'rivaroxaban 2.5\xa0mg twice daily and aspirin', 'Rivaroxaban Plus Aspirin', 'aspirin', 'Rivaroxaban']","['major bleeding received platelets, clotting factors, or other hemostatic agents', 'Major Bleeding', 'minor bleeding', 'need for any red cell transfusion', 'modified International Society on Thrombosis and Hemostasis major bleeding', 'adverse cardiovascular events and mortality and increased bleeding', 'major bleeding, mainly from the GI tract', 'excess bleeding', 'major bleeding', 'International Society on Thrombosis and Hemostasis major bleeding', 'gastrointestinal (GI) tract', 'number and proportion of patients; hazard rate ratios for bleeding', 'bleeding']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0005789', 'cui_str': 'Clotting Factors'}, {'cui': 'C0019120', 'cui_str': 'Hemostatics'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal Tract'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.122553,"Compared with aspirin alone, the combination increased modified International Society on Thrombosis and Hemostasis major bleeding (288 of 9,152 [3.1%] vs. 170 of 9,126 [1.9%]), (HR: 1.70; 95% CI: 1.40 to 2.05; p < 0.001), International Society on Thrombosis and Hemostasis major bleeding (206 of 9,152 [2.3%] vs. 116 of 9,126 [1.3%]), (HR: 1.78; 95% CI: 1.41 to 2.23; p < 0.0001), and minor bleeding (838 of 9,152 [9.2%] vs. 503 of 9,126 [5.5%]), (HR: 1.70; 95% CI 1.52 to 1.90; p < 0.0001); the combination also increased the need for any red cell transfusion (87 of 9,152 [1.0%] vs. 44 of 9,126 [0.5%]), (HR: 1.97; 95% CI 1.37 to 2.83, p = 0.0002).","[{'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Eikelboom', 'Affiliation': 'Hamilton Health Sciences, Hamilton, Ontario, Canada; McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, Canada. Electronic address: eikelbj@mcmaster.ca.'}, {'ForeName': 'Jacqueline J', 'Initials': 'JJ', 'LastName': 'Bosch', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Hamilton Health Sciences, Hamilton, Ontario, Canada; McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Shestakovska', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Gilles R', 'Initials': 'GR', 'LastName': 'Dagenais', 'Affiliation': 'Institut Universitaire de Cardiologie et Pneumologie de Québec, Québec, Québec, Canada.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hart', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Darryl P', 'Initials': 'DP', 'LastName': 'Leong', 'Affiliation': 'Hamilton Health Sciences, Hamilton, Ontario, Canada; McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': ""O'Donnell"", 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Harvard Medical School, Brigham and Women's Hospital Heart and Vascular Center, Boston, Massachusetts.""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Cairns', 'Affiliation': 'Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Tasto', 'Affiliation': 'Bayer AG, Leverkusen, Germany.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer AG, Whippany, New Jersey.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Cook Bruns', 'Affiliation': 'Bayer AG, Leverkusen, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Muehlhofer', 'Affiliation': 'Bayer AG, Leverkusen, Germany.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clínicos Latino America and Instituto Cardiovascular de Rosario, Rosario, Argentina.'}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Firenze, Italy.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Hamilton Health Sciences, Hamilton, Ontario, Canada; McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, Canada.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.07.065']
1716,31395122,Off-Pump Versus On-Pump Bypass Surgery for Left Main Coronary Artery Disease.,"BACKGROUND


Concerns remain for a greater risk of incomplete revascularization and reduced survival with off-pump coronary artery bypass grafting (CABG) surgery compared with on-pump surgery particularly in patients with left main disease and extensive underlying myocardial ischemia.
OBJECTIVES


This study sought to compare outcomes following off-pump versus on-pump surgery for left main disease by performing a post hoc analysis from the multicenter, randomized EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial.
METHODS


The EXCEL trial was designed to compare percutaneous coronary intervention with everolimus-eluting stents versus CABG in patients with left main disease. CABG was performed with or without cardiopulmonary bypass (on-pump vs. off-pump surgery) according to the discretion of the operator. The 3-year outcomes in the off-pump and on-pump groups were compared using inverse probability of treatment weighting (IPTW) for treatment effect estimation.
RESULTS


Among 923 CABG patients, 652 and 271 patients underwent on-pump and off-pump surgery, respectively. Despite a similar extent of disease, off-pump surgery was associated with a lower rate of revascularization of the left circumflex coronary artery (84.1% vs. 90.0%; p = 0.01) and right coronary artery (31.1% vs. 40.6%; p = 0.007). After IPTW adjustment for baseline differences, off-pump surgery was associated with a significantly increased risk of 3-year all-cause death (8.8% vs. 4.5%; hazard ratio: 1.94; 95% confidence interval: 1.10 to 3.41; p = 0.02) and a nonsignificant difference in the risk for the composite endpoint of death, myocardial infarction, or stroke (11.8% vs. 9.2%; hazard ratio: 1.28; 95% confidence interval: 0.82 to 2.00; p = 0.28).
CONCLUSIONS


Among patients with left main disease treated with CABG in the EXCEL trial, off-pump surgery was associated with a lower rate of revascularization of the coronary arteries supplying the inferolateral wall and an increased risk of 3-year all-cause death compared with on-pump surgery.",2019,"Despite a similar extent of disease, off-pump surgery was associated with a lower rate of revascularization of the left circumflex coronary artery (84.1% vs. 90.0%; p = 0.01) and right coronary artery (31.1% vs. 40.6%; p = 0.007).","['patients with left main disease and extensive underlying myocardial ischemia', '923 CABG patients, 652 and 271 patients underwent on-pump and off-pump surgery, respectively', 'patients with left main disease treated with', 'patients with left main disease']","['everolimus-eluting stents versus CABG', 'Off-Pump Versus On-Pump Bypass Surgery', 'pump coronary artery bypass grafting (CABG) surgery', 'CABG', 'pump versus on-pump surgery', 'XIENCE versus Coronary Artery Bypass Surgery']","['rate of revascularization of the left circumflex coronary artery', 'rate of revascularization of the coronary arteries supplying the inferolateral wall and an increased risk of 3-year all-cause death', '3-year outcomes', 'risk of 3-year all-cause death', 'death, myocardial infarction, or stroke', 'right coronary artery']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C1536078', 'cui_str': 'Bypass surgery'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1261316', 'cui_str': 'Right coronary artery structure'}]",923.0,0.311361,"Despite a similar extent of disease, off-pump surgery was associated with a lower rate of revascularization of the left circumflex coronary artery (84.1% vs. 90.0%; p = 0.01) and right coronary artery (31.1% vs. 40.6%; p = 0.007).","[{'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Benedetto', 'Affiliation': 'University of Bristol, Bristol, United Kingdom. Electronic address: umberto.benedetto@bristol.ac.uk.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Puskas', 'Affiliation': ""Mount Sinai Saint Luke's Hospital, New York, New York.""}, {'ForeName': 'Arie Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': 'Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'W Morris', 'Initials': 'WM', 'LastName': 'Brown', 'Affiliation': 'Piedmont Atlanta Hospital, Atlanta, Georgia.'}, {'ForeName': 'Ferenc', 'Initials': 'F', 'LastName': 'Horkay', 'Affiliation': 'National Institute of Cardiology, Budapest, Hungary.'}, {'ForeName': 'Piet W', 'Initials': 'PW', 'LastName': 'Boonstra', 'Affiliation': 'Medisch Centrum Leeuwarden, Leeuwarden, the Netherlands.'}, {'ForeName': 'Gabor', 'Initials': 'G', 'LastName': 'Bogáts', 'Affiliation': 'University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Noiseux', 'Affiliation': 'Hôpital Hôtel-Dieu de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Dressler', 'Affiliation': 'Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Gianni D', 'Initials': 'GD', 'LastName': 'Angelini', 'Affiliation': 'University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Cardiovascular Research Foundation, New York, New York; Columbia University Medical Center, New York, New York. Electronic address: https://twitter.com/GreggWStone.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'International Centre for Circulatory Health, NHLI, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Sabik', 'Affiliation': 'University Hospitals Cleveland Medical Center, Cleveland, Ohio.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Taggart', 'Affiliation': 'University of Oxford, Oxford, United Kingdom.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.05.063']
1717,31595845,Role of Ischemia Modified Albumin Serum Levels as an Oxidative Stress Marker in Children with Diabetic Ketoacidosis.,"AIM AND OBJECTIVE


Ischemia modified albumin (IMA) is a biomarker that has been introduced recently for use in the evaluation of oxidative stress. The aim of this study was to measure the ischemia modified albumin serum levels in pediatric patients with diabetic ketoacidosis (DKA) during acidosis and after the patient recovered from acidosis and to compare these with the control group.
MATERIALS AND METHODS


Pediatric patients with Type I diabetes mellitus (T1DM) who were admitted to the pediatric intensive care unit with the diabetic ketoacidosis were assigned as the study group and healthy children who were admitted to the outpatient clinic and decided as healthy after clinic and laboratory evaluation were selected as the control group. IMA and adjusted IMA levels were evaluated in the blood samples from the control group and the study group when admitted first time to the intensive care unit during the acidosis period (DKA before treatment, DKA-BT), and after recovering from acidosis (DKA after treatment, DKA-AT).
RESULTS


A total of 24 pediatric patients with diabetic ketoacidosis and 30 healthy control children matching age and sex were included in the current study. The albumin levels in pediatric patients with T1DM during DKA-BT were higher than the albumin levels after acidosis (4.101±0.373, 3.854±0.369 g/dL, respectively) (p<0.05). However, there was no significant difference when these values were compared to the control group. Mean values of IMA and Adj-IMA were statistically higher in DKAAT compared to the control group (0.748±0.150 vs 0.591±0.099, p< 0.001; 0.708±0.125 vs 0.607±0.824, p< 0.001, respectively). IMA and adjusted IMA levels measured after recovered from acidosis were significantly higher compared to the level of IMA during DKA (0.748±0.150 vs 0.606±0.105 as absorbance unit, p<0.001; 0.708±0.125 vs 0.625±0.100, p<0.05, respectively).
CONCLUSION


In children with T1DM, even though acidosis recovered following the treatment in diabetic ketoacidosis, which is an oxidative stress marker, the ischemia modified albumin levels and adjusted ischemia modified albumin levels were high.",2019,"Mean values of IMA and Adj-IMA were statistically higher in DKA-AT compared to the control group (0.748±0.150 vs 0.591±0.099, p < 0.001; 0.708±0.125","['Pediatric patients with Type I diabetes mellitus (T1DM), who were admitted to the pediatric intensive care unit with the diabetic ketoacidosis were assigned as the study group and healthy children who were admitted to outpatient clinic and decided as healthy after clinic and laboratory evaluation were selected as the control group', '24 pediatric patient with diabetic ketoacidosis and 30 healthy control child matching age and sex', 'pediatric patients with T1DM during DKA-BT', 'pediatric patients with diabetic ketoacidosis (DKA', 'Children with Diabetic Ketoacidosis']","['Ischemia Modified Albumin Serum Levels', 'Ischemia modified albumin (IMA']","['ischemia modified albumin serum levels', 'ischemia modified albumin levels and adjusted ischemia modified albumin levels', 'IMA and adjusted IMA levels', 'albumin levels', 'Mean values of IMA and Adj-IMA', 'IMA and adjusted IMA level']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0021710', 'cui_str': 'PICU - Pediatric intensive care unit'}, {'cui': 'C0011880', 'cui_str': 'Ketosis, Diabetic'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]","[{'cui': 'C3266190', 'cui_str': 'ischemia-modified serum albumin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}]","[{'cui': 'C3266190', 'cui_str': 'ischemia-modified serum albumin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0428519', 'cui_str': 'Albumin level - finding'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0458282,"Mean values of IMA and Adj-IMA were statistically higher in DKA-AT compared to the control group (0.748±0.150 vs 0.591±0.099, p < 0.001; 0.708±0.125","[{'ForeName': 'Mutlu U', 'Initials': 'MU', 'LastName': 'Yazıcı', 'Affiliation': 'Dr. Sami Ulus Maternity and Children Training and Research Hospital, University of Health Sciences, Pediatric Intensive Care, Ankara, Turkey.'}, {'ForeName': 'Ganime', 'Initials': 'G', 'LastName': 'Ayar', 'Affiliation': 'University of Health Sciences, Ankara Child Health and Diseases, Hematology Oncology Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Senay', 'Initials': 'S', 'LastName': 'Savas-Erdeve', 'Affiliation': 'Department of Pediatric Endocrinology, University of Health Sciences, Ankara Child Health and Diseases, Hematology Oncology Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Azapağası', 'Affiliation': 'Dr. Sami Ulus Maternity and Children Training and Research Hospital, University of Health Sciences, Pediatric Intensive Care, Ankara, Turkey.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Neşelioğlu', 'Affiliation': 'Department of Biochemistry, University of Yildirim Beyazit, Ankara Atatürk Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Özcan', 'Initials': 'Ö', 'LastName': 'Erel', 'Affiliation': 'Department of Biochemistry, University of Yildirim Beyazit, Ankara Atatürk Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Semra', 'Initials': 'S', 'LastName': 'Çetinkaya', 'Affiliation': 'Department of Pediatric Endocrinology, University of Health Sciences, Ankara Child Health and Diseases, Hematology Oncology Training and Research Hospital, Ankara, Turkey.'}]",Combinatorial chemistry & high throughput screening,['10.2174/1386207322666191008214919']
1718,32034789,Antibacterial effectiveness of calcium hydroxide alone or in combination with Ibuprofen and Ciprofloxacin in teeth with asymptomatic apical periodontitis: a randomized controlled clinical study.,"AIM


To evaluate the antimicrobial effectiveness of Ca(OH) 2  paste combined with Ibuprofen or Ciprofloxacin in infected root canals of teeth with asymptomatic apical periodontitis.
METHODOLOGY


Forty-five patients were randomly divided into three groups using a web programme according to the medication selected: Ca(OH) 2  : 1 g Ca(OH) 2  powder with 1 mL propylene glycol, Ca(OH) 2   + Ibuprofen: 50 mg of Ibuprofen was added into 950 mg Ca(OH) 2  powder and mixed with 1 mL propylene glycol, Ca(OH) 2   + Ciprofloxacin: 50 mg of Ciprofloxacin was added into 950 mg Ca(OH) 2  powder and mixed with 1 mL propylene glycol. Root canal bacteriological samples were collected before root canal treatment (S1) and after chemo-mechanical procedures (S2). After root canal preparation, the intracanal medicaments were placed into the root canals to a level approximately 1 mm short of the working length using K-files and access cavities were filled temporarily. The participants were scheduled for a second visit 7 days later when the medication was removed mechanically, and after irrigation of the root canals, the final samples (S3) were collected. Samples were subjected to quantitative real-time polymerase chain reaction to evaluate the numbers of total bacteria, Enterococcus faecalis and Streptococcus species. For intragroup analysis, a Friedman test was used to compare reduction of counts of total bacteria, Streptococci and E. faecalis amongst the three samples (S1, S2 and S3). The chi-square test was used to compare the number of root canals positive for bacteria in S1, S2 and S3 amongst the groups.
RESULTS


Intragroup analysis revealed a significant reduction in the number of intracanal bacterial cells from S1 to S2 and from S2 to S3 in all medication groups (P < 0.01). Although there was no significant difference amongst the groups when comparing quantitative S1 or S2 data, there were significantly lower bacterial counts in the Ca(OH) 2   + Ciprofloxacin group (0.49 × 10 2  ) than the pure Ca(OH) 2  (1.25 × 10 2  ) and Ca(OH) 2   + Ibuprofen groups (0.76 × 10 2  ) at S3. The percentage reduction from S1 to S3 and from S2 to S3 was significantly greater in the Ca(OH)2 + Ciprofloxacin than the pure Ca(OH)2 and Ca(OH)2 + Ibuprofen groups (P < 0.05). In the Ca(OH) 2   + Ciprofloxacin group, there were significantly fewer positive cases (8/15) than the pure Ca(OH) 2  (13/15) and Ca(OH) 2   + Ibuprofen (13/15) groups (P < 0.05).
CONCLUSION


The addition of Ciprofloxacin to Ca(OH) 2  provided further antibacterial effectiveness when used as an intracanal medicament in vivo during root canal treatment.",2020,"RESULTS


Intragroup analysis revealed a significant reduction in the number of intracanal bacterial cells from S1 to S2 and from S2 to S3 in all medication groups (P < 0.01).","['Forty-five patients', 'teeth with asymptomatic apical periodontitis', 'infected root canals of teeth with asymptomatic apical periodontitis']","['Ciprofloxacin', 'Ca(OH)2 + Ciprofloxacin', 'ibuprofen was added into 950 mg Ca(OH) 2  powder and mixed with 1 mL propylene glycol, Ca(OH) 2  + Ciprofloxacin', 'ciprofloxacin', 'ibuprofen and ciprofloxacin', 'ibuprofen or ciprofloxacin', 'Ibuprofen', 'web program according to the medication selected: Ca(OH) 2  : 1 g Ca(OH) 2  powder with 1 mL propylene glycol, Ca(OH) 2  + Ibuprofen', 'Ciprofloxacin was added into 950 mg Ca(OH) 2  powder and mixed with 1 mL propylene glycol', 'calcium hydroxide alone']","['counts of total bacteria, Streptococci and E. faecalis', 'Root canal bacteriological samples', 'bacterial counts', 'quantitative S1 or S2 data', 'number of intracanal bacterial cells', 'Antibacterial effectiveness']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0031030', 'cui_str': 'Periodontitis, Apical'}, {'cui': 'C0086881', 'cui_str': 'Root Canal'}]","[{'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C2603574', 'cui_str': 'Ca(BD4)2'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C4708800', 'cui_str': '950'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C4046690', 'cui_str': 'propylene glycol, (S)-'}, {'cui': 'C0596235', 'cui_str': 'Ca 2+'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}]","[{'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0086881', 'cui_str': 'Root Canal'}, {'cui': 'C0205465', 'cui_str': 'Bacteriologic (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0004618', 'cui_str': 'Bacterial Count'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0279516', 'cui_str': 'Anti-Bacterial Agents'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",45.0,0.0192476,"RESULTS


Intragroup analysis revealed a significant reduction in the number of intracanal bacterial cells from S1 to S2 and from S2 to S3 in all medication groups (P < 0.01).","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Karataş', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'M Ö', 'Initials': 'MÖ', 'LastName': 'Baltacı', 'Affiliation': 'Molecular Biology and Genetics, Microbiology, Faculty of Science, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Uluköylü', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Adıgüzel', 'Affiliation': 'Molecular Biology and Genetics, Microbiology, Faculty of Science, Ataturk University, Erzurum, Turkey.'}]",International endodontic journal,['10.1111/iej.13277']
1719,31332920,Application of the H 2  FPEF score to a global clinical trial of patients with heart failure with preserved ejection fraction: the TOPCAT trial.,,2019,,['patients with heart failure with preserved ejection fraction'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]",[],[],,0.0316763,,"[{'ForeName': 'Peder L', 'Initials': 'PL', 'LastName': 'Myhre', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore, Duke-National University of Singapore, Singapore.'}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'VA Medical Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Nancy K', 'Initials': 'NK', 'LastName': 'Sweitzer', 'Affiliation': 'University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Fang', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': 'Montreal Heart Institute, University of Montreal, Montreal, QC, Canada.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Amil M', 'Initials': 'AM', 'LastName': 'Shah', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Eldrin F', 'Initials': 'EF', 'LastName': 'Lewis', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Rouleau', 'Affiliation': 'Montreal Heart Institute, University of Montreal, Montreal, QC, Canada.'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'University of Michigan School of Medicine, Ann Arbor, MI, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}]",European journal of heart failure,['10.1002/ejhf.1542']
1720,31284175,The impact of psychostimulants on sustained attention over a 24-h period.,"The off-label use of psychostimulants is a growing trend in healthy adults with many turning to these medications to increase alertness, attentional focus, and to help them study. However, the empirical literature on the efficacy of these medications for cognitive enhancement is controversial and the longer-term impact of these drugs on health and cognitive processing has not been thoroughly examined. Specifically, sleep supports daytime alertness, vigilance, and sustained attention, yet stimulants significantly disrupt sleep. Here, using a double-blind, placebo-controlled, crossover design, we tested the impact morning administration of psychostimulants (dextroamphetamine; DEX) had on: (1) tests of attention 75-min and 12-h after drug ingestion, (2) nighttime sleep and (3) post-sleep attention in healthy, young adults. First, we found that repeated testing led to significant decreases in performance from baseline in the placebo condition, and that DEX, compared to placebo, prevented deterioration at the 75-min test, and selectively for visual field at the 12 h and 24 h tests. We also found that stimulants, compared to placebo, benefitted attentional processing 75-min post-drug but this did not persist to the delayed test 12-h after drug administration. Additionally, morning stimulant administration resulted in robust nighttime sleep disruptions, yet post-sleep sustained attention was equivalent in the stimulant and placebo conditions, indicating that the initial boost to performance dissipated at 24 h, but the decrease was not significantly worse than placebo. Together, these results suggest that stimulant medications, commonly used off-label for cognitive enhancement may prevent deterioration of sustained attention brought on by repeated within-day testing. Additionally, these medications substantially disrupt nighttime sleep; which while coming at little cost to next-day attentional processing, may have steeper consequences for other cognitive domains.",2019,"We also found that stimulants, compared to placebo, benefitted attentional processing 75-min post-drug","['healthy, young adults', 'healthy adults']","['attention 75-min and 12-h after drug ingestion, (2) nighttime sleep and (3) post-sleep attention', 'psychostimulants (dextroamphetamine; DEX', 'placebo', 'DEX']","['robust nighttime sleep disruptions', 'nighttime sleep', 'sleep supports daytime alertness, vigilance, and sustained attention']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0304403', 'cui_str': 'Psychostimulant'}, {'cui': 'C0011812', 'cui_str': 'dexamfetamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332453', 'cui_str': 'Disruption (morphologic abnormality)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention, function (observable entity)'}]",,0.163138,"We also found that stimulants, compared to placebo, benefitted attentional processing 75-min post-drug","[{'ForeName': 'Lauren N', 'Initials': 'LN', 'LastName': 'Whitehurst', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA, USA. Electronic address: lauren.whitehurst@ucsf.edu.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Agosta', 'Affiliation': 'Center for Neuroscience and Cognitive Systems@UniTn, Istituto Italiano di Tecnologia, Rovereto, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Castaños', 'Affiliation': 'School of Medicine, University of California, Riverside, CA, USA.'}, {'ForeName': 'Lorella', 'Initials': 'L', 'LastName': 'Battelli', 'Affiliation': 'Center for Neuroscience and Cognitive Systems@UniTn, Istituto Italiano di Tecnologia, Rovereto, Italy; Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Mednick', 'Affiliation': 'Department of Cognitive Science, University of California, Irvine, USA.'}]",Cognition,['10.1016/j.cognition.2019.104015']
1721,4923243,Weight gain with cyproheptadine hydrochloride ('Periactin'). A double blind trial in underweight medical students.,,1970,,['underweight medical students'],"[""cyproheptadine hydrochloride ('Periactin""]",['Weight gain'],"[{'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0354872', 'cui_str': 'Cyproheptadine hydrochloride'}, {'cui': 'C0031017', 'cui_str': 'Periactin'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",,0.236066,,"[{'ForeName': 'H V', 'Initials': 'HV', 'LastName': 'Sardesai', 'Affiliation': ''}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Melinkeri', 'Affiliation': ''}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Diwate', 'Affiliation': ''}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Karandikar', 'Affiliation': ''}, {'ForeName': 'P V', 'Initials': 'PV', 'LastName': 'Joshi', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1722,31477545,"Fixed-combination, low-dose, triple-pill antihypertensive medication versus usual care in patients with mild-to-moderate hypertension in Sri Lanka: a within-trial and modelled economic evaluation of the TRIUMPH trial.","BACKGROUND


Elevated blood pressure incurs a major health and economic burden, particularly in low-income and middle-income countries. The Triple Pill versus Usual Care Management for Patients with Mild-to-Moderate Hypertension (TRIUMPH) trial showed a greater reduction in blood pressure in patients using fixed-combination, low-dose, triple-pill antihypertensive therapy (consisting of amlodipine, telmisartan, and chlorthalidone) than in those receiving usual care in Sri Lanka. We aimed to assess the cost-effectiveness of the triple-pill strategy.
METHODS


We did a within-trial (6-month) and modelled (10-year) economic evaluation of the TRIUMPH trial, using the health system perspective. Health-care costs, reported in 2017 US dollars, were determined from trial records and published literature. A discrete-time simulation model was developed, extrapolating trial findings of reduced systolic blood pressure to 10-year health-care costs, cardiovascular disease events, and mortality. The primary outcomes were the proportion of people reaching blood pressure targets (at 6 months from baseline) and disability-adjusted life-years (DALYs) averted (at 10 years from baseline). Incremental cost-effectiveness ratios were calculated to estimate the cost per additional participant achieving target blood pressure at 6 months and cost per DALY averted over 10 years.
FINDINGS


The triple-pill strategy, compared with usual care, cost an additional US$9·63 (95% CI 5·29 to 13·97) per person in the within-trial analysis and $347·75 (285·55 to 412·54) per person in the modelled analysis. Incremental cost-effectiveness ratios were estimated at $7·93 (95% CI 6·59 to 11·84) per participant reaching blood pressure targets at 6 months and $2842·79 (-28·67 to 5714·24) per DALY averted over a 10-year period.
INTERPRETATION


Compared with usual care, the triple-pill strategy is cost-effective for patients with mild-to-moderate hypertension. Scaled up investment in the triple pill for hypertension management in Sri Lanka should be supported to address the high population burden of cardiovascular disease.
FUNDING


Australian National Health and Medical Research Council.",2019,"Compared with usual care, the triple-pill strategy is cost-effective for patients with mild-to-moderate hypertension.","['Patients with Mild-to-Moderate Hypertension (TRIUMPH) trial', 'patients with mild-to-moderate hypertension in Sri Lanka', 'patients with mild-to-moderate hypertension']","['amlodipine, telmisartan, and chlorthalidone', 'Fixed-combination, low-dose, triple-pill antihypertensive medication versus usual care', 'Triple Pill versus Usual Care Management']","['disability-adjusted life-years (DALYs) averted', 'systolic blood pressure to 10-year health-care costs, cardiovascular disease events, and mortality', 'proportion of people reaching blood pressure targets', 'blood pressure', 'Incremental cost-effectiveness ratios', 'cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0038088', 'cui_str': 'Ceylon'}]","[{'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0008294', 'cui_str': 'Chlorthalidone'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0282620', 'cui_str': 'Adjusted Life Years'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.167717,"Compared with usual care, the triple-pill strategy is cost-effective for patients with mild-to-moderate hypertension.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lung', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia; Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia. Electronic address: tlung@georgeinstitute.org.au.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jan', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia; Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'H Asita', 'Initials': 'HA', 'LastName': 'de Silva', 'Affiliation': 'Clinical Trials Unit, Department of Pharmacology, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka.'}, {'ForeName': 'Rama', 'Initials': 'R', 'LastName': 'Guggilla', 'Affiliation': 'Department of Population Medicine and Civilization Diseases Prevention, Faculty of Medicine with the Division of Dentistry and Division of Medical Education in English, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Pallab K', 'Initials': 'PK', 'LastName': 'Maulik', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, New Delhi, India; The George Institute for Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nitish', 'Initials': 'N', 'LastName': 'Naik', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Anushka', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Arjuna P', 'Initials': 'AP', 'LastName': 'de Silva', 'Affiliation': 'Department of Medicines, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka.'}, {'ForeName': 'Senaka', 'Initials': 'S', 'LastName': 'Rajapakse', 'Affiliation': 'Department of Medicines, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.'}, {'ForeName': 'Gotabhaya', 'Initials': 'G', 'LastName': 'Ranasinghe', 'Affiliation': 'Institute of Cardiology, National Hospital of Sri Lanka, Colombo, Sri Lanka.'}, {'ForeName': 'Dorairaj', 'Initials': 'D', 'LastName': 'Prabhakaran', 'Affiliation': 'Centre for Chronic Disease Control, New Delhi, India.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rodgers', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Salam', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Hyderabad, India.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Selak', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Stepien', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Thom', 'Affiliation': 'International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Webster', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Lea-Laba', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Global health,['10.1016/S2214-109X(19)30343-2']
1723,31304536,MSG-10: a Phase 2 study of oral ibrexafungerp (SCY-078) following initial echinocandin therapy in non-neutropenic patients with invasive candidiasis.,"OBJECTIVES


To evaluate the safety and efficacy of two dosing regimens of oral ibrexafungerp (formerly SCY-078), a novel orally bioavailable β-glucan synthase inhibitor, in subjects with invasive candidiasis versus the standard of care (SOC) and to identify the dose to achieve target exposure (15.4 μM·h) in >80% of the intended population.
METHODS


In a multinational, open-label study, patients with documented invasive candidiasis were randomized to receive step-down therapy to one of three treatment arms: two dosing regimens of novel oral ibrexafungerp or the SOC treatment following initial echinocandin therapy. Plasma samples were collected to evaluate exposure by population pharmacokinetic (PK) modelling. Safety was assessed throughout the study and global response at the end of treatment.
RESULTS


Out of 27 subjects enrolled, 7 received ibrexafungerp 500 mg, 7 received ibrexafungerp 750 mg and 8 received the SOC. Five did not meet criteria for randomization. Population PK analysis indicated that an ibrexafungerp 750 mg regimen is predicted to achieve the target exposure in ∼85% of the population. The rate of adverse events was similar among patients receiving ibrexafungerp or fluconazole. Similar favourable response rates were reported among all groups: 86% (n = 6) in the ibrexafungerp 750 mg versus 71% (n = 5) in both the fluconazole and ibrexafungerp 500 mg treatment arms. The one subject treated with continued micafungin had a favourable global response.
CONCLUSIONS


The oral ibrexafungerp dose estimated to achieve the target exposure in subjects with invasive candidiasis is 750 mg daily. This dose was well tolerated and achieved a favourable global response rate, similar to the SOC.",2019,Similar favourable response rates were reported among all groups: 86% (n = 6) in the ibrexafungerp 750 mg versus 71% (n = 5) in both the fluconazole and ibrexafungerp 500 mg treatment arms.,"['27 subjects enrolled, 7 received', 'patients with documented invasive candidiasis', 'subjects with invasive candidiasis versus the standard of care (SOC) and to identify the dose to achieve target exposure (15.4\u2009μM·h) in >80% of the intended population', 'non-neutropenic patients with invasive candidiasis', 'subjects with invasive candidiasis']","['echinocandin therapy', 'ibrexafungerp 500\u2009mg, 7 received ibrexafungerp 750\u2009mg and 8 received the SOC', 'novel oral ibrexafungerp or the SOC treatment following initial echinocandin therapy', 'MSG-10', 'oral ibrexafungerp (formerly SCY-078', 'fluconazole', 'oral ibrexafungerp (SCY-078']","['rate of adverse events', 'response rates', 'Safety', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C4517579', 'cui_str': '15.4 (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C1268551', 'cui_str': 'Echinocandins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C4521594', 'cui_str': 'Senior Chief Petty Officer'}, {'cui': 'C4547381', 'cui_str': 'SCY-078'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",27.0,0.0240353,Similar favourable response rates were reported among all groups: 86% (n = 6) in the ibrexafungerp 750 mg versus 71% (n = 5) in both the fluconazole and ibrexafungerp 500 mg treatment arms.,"[{'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Spec', 'Affiliation': 'Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Pullman', 'Affiliation': 'Mercury Street Medical, Butte, MT, USA.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Thompson', 'Affiliation': 'University of California-Davis, Sacramento, CA, USA.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Powderly', 'Affiliation': 'Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Ellis H', 'Initials': 'EH', 'LastName': 'Tobin', 'Affiliation': 'Albany Medical Center, Albany, NY, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Vazquez', 'Affiliation': 'Medical College of Georgia/Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Wring', 'Affiliation': 'Scynexis, Inc., Jersey City, NJ, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Angulo', 'Affiliation': 'Scynexis, Inc., Jersey City, NJ, USA.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Helou', 'Affiliation': 'Scynexis, Inc., Jersey City, NJ, USA.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Pappas', 'Affiliation': 'University of Alabama, Birmingham, AL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz277']
1724,30838382,Cost-utility analysis of minimally invasive surgery for lung cancer: a randomized controlled trial.,"OBJECTIVES


Minimally invasive video-assisted thoracic surgery (VATS) was first introduced in the early 1990s. For decades, numerous non-randomized studies demonstrated advantages of VATS over thoracotomy with lower morbidity and shorter hospital stay, but only recently did a randomized trial document that VATS results in lower pain scores and better quality of life. Opposing arguments for VATS have always been increased costs and concerns about oncological adequacy. In this paper, we aim to investigate the cost-effectiveness of VATS.
METHODS


The study was designed as a cost-utility analysis of the first 12 months following surgery and was performed together with a clinical randomized controlled trial of VATS versus thoracotomy for lobectomy of stage 1 lung cancer during a 6-year period (2008-2014). All health-related expenses were retrieved from a national database (Statistics Denmark) including hospital readmissions, outpatient clinic visits, prescription medication costs, consultations with general practitioners, specialists, physiotherapists, psychologists and chiropractors.
RESULTS


One hundred and three VATS patients and 103 thoracotomy patients were randomized. Mean costs per patient operated by VATS were 103 108 Danish Kroner (Dkr) (€13 818) and 134 945 Dkr (€18 085) by thoracotomy, making the costs for VATS 31 837 Dkr (€4267) lower than thoracotomy (P < 0.001). The difference in quality-adjusted life years gained over 52 weeks of follow-up was 0.021 (P = 0.048, 95% confidence interval -0.04 to -0.00015) in favour of VATS. The median duration of the surgical procedure was shorter after thoracotomy (79 vs 100 min; P < 0.001). The mean length of hospitalization was shorter following VATS (4.8 vs 6.7 days; P = 0.027). The use of other resources was not significantly different between groups. The costs of resources were lower in the VATS group. This difference was primarily due to reduced costs of readmissions (VATS 29 247 Dkr vs thoracotomy 51 734 Dkr; P < 0.001) and costs of outpatient visits (VATS 51 412 Dkr vs thoracotomy 61 575 Dkr; P = 0.012).
CONCLUSIONS


VATS is a cost-effective alternative to thoracotomy following lobectomy for stage 1 lung cancer. Economical outcomes as measured by quality-adjusted life years were significantly better and overall costs were lower for VATS.
CLINICAL TRIAL REGISTRATION NUMBER


NCT01278888.",2019,The difference in quality-adjusted life years gained over 52 weeks of follow-up was 0.021,"['945', 'All health-related expenses were retrieved from a national database (Statistics Denmark) including hospital readmissions, outpatient clinic visits, prescription medication costs, consultations with general practitioners, specialists, physiotherapists, psychologists and chiropractors', 'lung cancer', 'One hundred and three VATS patients and 103 thoracotomy patients', 'for lobectomy of stage 1 lung cancer during a 6-year period (2008-2014']","['Minimally invasive video-assisted thoracic surgery (VATS', 'VATS versus thoracotomy', 'minimally invasive surgery', 'VATS']","['Mean costs', 'costs of outpatient visits', 'costs of readmissions', 'costs of resources', 'pain scores and better quality of life', 'overall costs', 'mean length of hospitalization', 'quality-adjusted life years', 'median duration of the surgical procedure']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0334952', 'cui_str': 'Chiropractor (occupation)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039991', 'cui_str': 'Thoracotomy'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland (procedure)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0039991', 'cui_str': 'Thoracotomy'}, {'cui': 'C0282624', 'cui_str': 'Minimal Surgical Procedures'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",,0.185978,The difference in quality-adjusted life years gained over 52 weeks of follow-up was 0.021,"[{'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Bendixen', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Odense University Hospital., Odense, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kronborg', 'Affiliation': 'Centre of Health Economic Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Ole Dan', 'Initials': 'OD', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Odense University Hospital., Odense, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Andersen', 'Affiliation': 'Department of Thoracic Anaesthesiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Peter Bjørn', 'Initials': 'PB', 'LastName': 'Licht', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Odense University Hospital., Odense, Denmark.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezz064']
1725,31537372,A social empowerment intervention to prevent intimate partner violence against women in a microfinance scheme in Tanzania: findings from the MAISHA cluster randomised controlled trial.,"BACKGROUND


Globally, about 30% of women have experienced physical or sexual violence, or both, from an intimate partner during their lifetime. Associations between poverty and women's increased risk of intimate partner violence have been observed. We therefore aimed to assess the effect of a violence prevention intervention delivered to women participating in a group-based microfinance scheme in Tanzania.
METHODS


We did a cluster randomised controlled trial among women taking part in a microfinance loan scheme in Mwanza city, Tanzania. A microfinance loan group was only enrolled if at least 70% of members consented. We randomly assigned the microfinance groups in blocks of six to receive either the intervention (ie, the intervention arm) or be wait-listed for the intervention after the trial (ie, the control arm). Women in both arms of the trial met weekly for loan repayments. Only those in the intervention arm participated in the ten-session MAISHA intervention that aims to empower women and prevent intimate partner violence. Given the nature of the intervention, it was not possible to mask participants or the research team. The primary outcome was a composite of reported past-year physical or sexual intimate partner violence, or both. Secondary outcome measures were past-year physical, sexual, and emotional intimate partner violence; acceptability and tolerance of intimate partner violence; and attitudes and beliefs related to intimate partner violence. These outcomes were assessed 24 months after the intervention. An intention-to-treat analysis was done, adjusting for age, education, and baseline measure of the respective outcome. The study is registered with ClinicalTrials.gov, number NCT02592252.
FINDINGS


Between September, 2014, and June, 2015, 66 (65%) of 101 microfinance groups approached in the study area met the trial eligibility criteria and were enrolled, of which 33 (n=544 women) were allocated to the intervention arm and 33 (n=505 women) to the control arm. Overall, 485 (89%) of 544 women in the intervention arm and 434 (86%) of 505 in the control arm completed the outcomes assessment. Among the intervention arm, 112 (23%) of 485 women reported past-year physical or sexual intimate partner violence, or both, compared with 119 (27%) of 434 in the control arm (adjusted odds ratio [aOR] 0·69, 95% CI 0·47-1·01; p=0·056). Women in the intervention arm were less likely to report physical intimate partner violence (aOR 0·64, 95% CI 0·41-0·99; p=0·043) and were less likely to express attitudes accepting of intimate partner violence (0·45, 0·34-0·61; p<0·0001) or beliefs that intimate partner violence is a private matter (0·51, 0·32-0·81; p=0·005) or should be tolerated (0·68, 0·45-1·01; p=0·055). There was no evidence of an effect on reported sexual or emotional intimate partner violence. There were no reports that participation in the trial had led to new episodes of violence or worsening of ongoing violence and abuse.
INTERPRETATION


Reported physical or sexual intimate partner violence, or both, was reduced among women who participated in the intervention arm, although the effect was greater for physical intimate partner violence, suggesting that intimate partner violence is preventable in high-risk settings such as Tanzania.
FUNDING


Anonymous donor and STRIVE Consortium.",2019,"There were no reports that participation in the trial had led to new episodes of violence or worsening of ongoing violence and abuse.
","['women participating in a group-based microfinance scheme in Tanzania', 'intimate partner violence against women in a microfinance scheme in Tanzania', 'women taking part in a microfinance loan scheme in Mwanza city, Tanzania', 'Between September, 2014, and June, 2015, 66 (65%) of 101 microfinance groups approached in the study area met the trial eligibility criteria and were enrolled, of which 33 (n=544 women']","['violence prevention intervention', 'social empowerment intervention']","['composite of reported past-year physical or sexual intimate partner violence, or both', 'past-year physical or sexual intimate partner violence', 'sexual or emotional intimate partner violence', 'past-year physical, sexual, and emotional intimate partner violence; acceptability and tolerance of intimate partner violence; and attitudes and beliefs related to intimate partner violence', 'risk of intimate partner violence', 'report physical intimate partner violence', 'attitudes accepting of intimate partner violence', 'new episodes of violence or worsening of ongoing violence and abuse', 'intimate partner violence']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0150215', 'cui_str': 'Violence prevention'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0565959', 'cui_str': 'New episode (qualifier value)'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}]",544.0,0.167183,"There were no reports that participation in the trial had led to new episodes of violence or worsening of ongoing violence and abuse.
","[{'ForeName': 'Saidi', 'Initials': 'S', 'LastName': 'Kapiga', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania; Department of Infectious Diseases Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Harvey', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania; Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK. Electronic address: sheila.harvey@lshtm.ac.uk.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Mshana', 'Affiliation': 'National Institute for Medical Research, Mwanza, Tanzania.'}, {'ForeName': 'Christian Holm', 'Initials': 'CH', 'LastName': 'Hansen', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Grace J', 'Initials': 'GJ', 'LastName': 'Mtolela', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Madaha', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Ramadhan', 'Initials': 'R', 'LastName': 'Hashim', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Imma', 'Initials': 'I', 'LastName': 'Kapinga', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Neema', 'Initials': 'N', 'LastName': 'Mosha', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Abramsky', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Lees', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Watts', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30316-X']
1726,31158720,Examining raphe-amygdala structural connectivity as a biological predictor of SSRI response.,"BACKGROUND


Our lab has previously found that structural integrity in tracts from the raphe nucleus (RN) to the amygdala, measured by fractional anisotropy (FA), predicts remission to selective serotonin reuptake inhibitors (SSRIs) in major depressive disorder (MDD). This could potentially serve as a biomarker for remission that can guide clinical decision-making. To enhance repeatability and reproducibility, we replicated our study in a larger, more representative multi-site sample.
METHODS


64 direction DTI was collected in 144 medication-free patients with MDD from the Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care (EMBARC) study. We performed probabilistic tractography between the RN and bilateral amygdala and hippocampus and calculated weighted FA in these tracts. Patients were treated with either sertraline or placebo, and their change in Hamilton Depression Rating Scale (HDRS) score reported. Pretreatment weighted FA was compared between remitters and nonremitters, and correlation between FA and percent change in HDRS score was assessed. Exploratory moderator and voxel analyses were also performed.
RESULTS


Contrary to our hypotheses, FA was greater in nonremitters than in remitters in RN-left and right amygdala tracts (p = 0.02 and 0.01, respectively). Pretreatment FA between the raphe and left amygdala correlated with greater, not reduced, HDRS (r = 0.18, p = 0.04). This finding was found to be greater in the placebo group. Moderator and voxel analyses yielded no significant findings.
CONCLUSIONS


We found greater FA in nonremitters between the RN and amygdala than in remitters, and a correlation between FA and symptom worsening, particularly with placebo. These findings may help reveal more about the nature of MDD, as well as guide research methods involving placebo response.",2019,"We found greater FA in nonremitters between the RN and amygdala than in remitters, and a correlation between FA and symptom worsening, particularly with placebo.",['64 direction DTI was collected in 144 medication-free patients with MDD from the Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care'],"['placebo', 'sertraline or placebo']","['Hamilton Depression Rating Scale (HDRS) score', 'HDRS score', 'HDRS']","[{'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",64.0,0.0464468,"We found greater FA in nonremitters between the RN and amygdala than in remitters, and a correlation between FA and symptom worsening, particularly with placebo.","[{'ForeName': 'Rajapillai L I', 'Initials': 'RLI', 'LastName': 'Pillai', 'Affiliation': 'Department of Psychiatry, Stony Brook University, Stony Brook, NY, United States.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, Stony Brook University, Stony Brook, NY, United States; Department of Radiology, Stony Brook University, Stony Brook, NY, United States. Electronic address: chuan.huang@stonybrookmedicine.edu.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'LaBella', 'Affiliation': 'Department of Biomedical Engineering, Stony Brook University, Stony Brook, NY, United States.'}, {'ForeName': 'Mengru', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Applied Mathematics and Statistics, Stony Brook University, Stony Brook, NY, United States.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Family, Population, & Preventive Medicine, Stony Brook University, Stony Brook, NY, United States.'}, {'ForeName': 'Madhukar', 'Initials': 'M', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, United States.'}, {'ForeName': 'Myrna', 'Initials': 'M', 'LastName': 'Weissman', 'Affiliation': 'Department of Psychiatry, College of Physicians and Surgeons, Columbia University and the New York Psychiatric Institute, United States.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'McGrath', 'Affiliation': 'Department of Psychiatry, College of Physicians and Surgeons, Columbia University and the New York Psychiatric Institute, United States.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, United States.'}, {'ForeName': 'Benji', 'Initials': 'B', 'LastName': 'Kurian', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, United States.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, United States.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, United States.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Oquendo', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, United States.'}, {'ForeName': 'Ramin V', 'Initials': 'RV', 'LastName': 'Parsey', 'Affiliation': 'Department of Psychiatry, Stony Brook University, Stony Brook, NY, United States.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'DeLorenzo', 'Affiliation': 'Department of Psychiatry, Stony Brook University, Stony Brook, NY, United States; Department of Psychiatry, Molecular Imaging and Neuropathology Division, Columbia University, New York, NY, United States.'}]",Journal of affective disorders,['10.1016/j.jad.2019.05.055']
1727,31502637,Usefulness of myocardial work measurement in the assessment of left ventricular systolic reserve response to spironolactone in heart failure with preserved ejection fraction.,"AIMS


Improvement in left ventricular (LV) systolic reserve, including exertional increase in global longitudinal strain (GLS), may contribute to the clinical benefit from therapeutic interventions in heart failure with preserved ejection fraction (HFpEF). However, GLS is an afterload-dependent parameter, and its measurements may not adequately reflect myocardial contractility recruitment with exercise. The estimation of myocardial work (MW) allows correction of GLS for changing afterload. We sought to investigate the associations of GLS and MW parameters with the response of exercise capacity to spironolactone in HFpEF.
METHODS AND RESULTS


We analysed 114 patients (67 ± 8 years) participating in the STRUCTURE study (57 randomized to spironolactone and 57 to placebo). Resting and immediately post-exercise echocardiograms were performed at baseline and at 6-month follow-up. The following indices of MW were assessed: global work index (GWI), global constructive work (GCW), global wasted work, and global work efficiency. The amelioration of exercise intolerance at follow-up in the spironolactone group was accompanied by a significant improvement in exertional increase in GCW (P = 0.002) but not in GLS and other MW parameters. Increase in exercise capacity at 6 months was independently correlated with change in exertional increase in GCW from baseline to follow-up (β = 0.24; P = 0.009) but not with GLS (P = 0.14); however, no significant interaction with the use of spironolactone on peak VO2 was found (P = 0.97).
CONCLUSION


GCW as a measure of LV contractile response to exertion is a better determinant of exercise capacity in HFpEF than GLS. Improvement in functional capacity during follow-up is associated with improvement in exertional increment of GCW.",2019,"Increase in exercise capacity at 6 months was independently correlated with change in exertional increase in GCW from baseline to follow-up (β = 0.24; P = 0.009) but not with GLS (P = 0.14); however, no significant interaction with the use of spironolactone on peak VO2 was found (P = 0.97).
","['114 patients (67\u2009±\u20098\u2009years) participating in the STRUCTURE study (57 randomized to', 'heart failure with preserved ejection fraction', 'heart failure with preserved ejection fraction (HFpEF']","['spironolactone and 57 to placebo', 'GLS', 'spironolactone']","['global work index (GWI), global constructive work (GCW), global wasted work, and global work efficiency', 'peak VO2', 'exertional increase in GCW', 'exercise capacity', 'functional capacity', 'left ventricular (LV) systolic reserve', 'amelioration of exercise intolerance']","[{'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0235394', 'cui_str': 'Wasting'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1701256', 'cui_str': 'bis(acetylacetonato)oxovanadium(IV)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}]",114.0,0.0251786,"Increase in exercise capacity at 6 months was independently correlated with change in exertional increase in GCW from baseline to follow-up (β = 0.24; P = 0.009) but not with GLS (P = 0.14); however, no significant interaction with the use of spironolactone on peak VO2 was found (P = 0.97).
","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Przewlocka-Kosmala', 'Affiliation': 'Cardiology Department, Wroclaw Medical University, Borowska 213, Wroclaw, Poland.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Marwick', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, 17 Liverpool St, Hobart TAS, Australia.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Mysiak', 'Affiliation': 'Cardiology Department, Wroclaw Medical University, Borowska 213, Wroclaw, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Kosowski', 'Affiliation': 'Cardiology Department, Wroclaw Medical University, Borowska 213, Wroclaw, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Kosmala', 'Affiliation': 'Cardiology Department, Wroclaw Medical University, Borowska 213, Wroclaw, Poland.'}]",European heart journal cardiovascular Imaging,['10.1093/ehjci/jez027']
1728,32073874,Effects of  Viola odorata  as an Add-On Therapy on Insomnia in Patients with Obsession or Depression: A Pilot Randomized Double-Blind Placebo-Controlled Trial.,"Objective:  The present study was conducted to investigate the effect of  Viola odorata  extracted syrup on the quality and patterns of sleep in patients with depression or obsessive-compulsive disorder (OCD) as add-on therapy.  Design:  A pilot double-blind randomized placebo-controlled trial.  Settings/Location:  Psychiatric Clinic of Imam Hossein Hospital, Tehran, Iran.  Subjects:  Participants were 16-15 years of age with mild and moderate depression or OCD having insomnia.  Interventions:  This pilot study was conducted on patients with insomnia divided into two groups with depression (40 patients) or OCD (43 patients). Each group randomly assigned into two arms with the same conditions at baseline. The intervention arm daily received 5 mL  V. odorata  syrup every 12 h for 4 weeks, and the control arm received 5 mL placebo syrup every 12 h for 4 weeks. None of the participants was deprived of their routine treatment for depression or OCD.  Outcome measures:  The scores of insomnia symptoms were evaluated using total score of the Pittsburgh Sleep Quality Index (PSQI) and the scores of its components, the depression score using the final Beck depression inventory-II (BDI-II) score, and OCD score using the Yale-Brown Obsessive-Compulsive Scale (YBOCS).  Results:  The total PSQI score was found to be improved significantly in the intervention arms with depression or OCD ( p  < 0.001) compared with the corresponding control arms. Significant improvements were also observed in the final mean difference of BDI-II ( p  = 0.009) and YBOCS ( p  = 0.001) scores in the intervention arms.  Conclusions:   V. odorata  syrup significantly improved insomnia symptoms and the scores of depression and OCD.",2020,Significant improvements were also observed in the final mean difference of BDI-II ( p  = 0.009) and YBOCS ( p  = 0.001) scores in the intervention arms.  ,"['Patients with Obsession or Depression', 'patients with depression or obsessive-compulsive disorder (OCD', 'Settings/Location:  Psychiatric Clinic of Imam Hossein Hospital, Tehran, Iran', 'Participants were 16-15 years of age with mild and moderate depression or OCD having insomnia', 'patients with insomnia divided into two groups with depression (40 patients) or OCD (43 patients', 'Subjects']","['placebo', 'control arm received 5\u2009mL placebo syrup', 'Placebo']","['final mean difference of BDI-II', 'scores of insomnia symptoms', 'YBOCS', 'total score of the Pittsburgh Sleep Quality Index (PSQI) and the scores of its components, the depression score using the final Beck depression inventory-II (BDI-II) score, and OCD score using the Yale-Brown Obsessive-Compulsive Scale (YBOCS', 'quality and patterns of sleep', 'insomnia symptoms and the scores of depression and OCD', 'total PSQI score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0233697', 'cui_str': 'Obsessions'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0588007', 'cui_str': 'Moderate depression (disorder)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0458173', 'cui_str': 'Syrup (substance)'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0222045'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",43.0,0.267057,Significant improvements were also observed in the final mean difference of BDI-II ( p  = 0.009) and YBOCS ( p  = 0.001) scores in the intervention arms.  ,"[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shayesteh', 'Affiliation': 'Department of Traditional Medicine, Faculty of Medicine, Shahed University, Tehran, Iran.'}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Vaez-Mahdavi', 'Affiliation': 'Department of Traditional Medicine, Faculty of Medicine, Shahed University, Tehran, Iran.'}, {'ForeName': 'Jamal', 'Initials': 'J', 'LastName': 'Shams', 'Affiliation': 'Behavioral Sciences Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Kamalinejad', 'Affiliation': 'School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Soghrat', 'Initials': 'S', 'LastName': 'Faghihzadeh', 'Affiliation': 'Department of Biostatistics and Epidemiology, Faculty of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Gholami-Fesharaki', 'Affiliation': 'Department of Biostatistics, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Gharebaghi', 'Affiliation': 'International Virtual Ophthalmic Research Center, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Heidary', 'Affiliation': 'Immunoregulation Research Center, Shahed University, Tehran, Iran.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0254']
1729,20689928,Patients' prediction of extubation success.,"PURPOSE


The spontaneous breathing trial (SBT)-relying on objective criteria assessed by the clinician-is the major diagnostic tool to determine if patients can be successfully extubated. However, little is known regarding the patient's subjective perception of autonomous breathing.
METHODS


We performed a prospective observational study in 211 mechanically ventilated adult patients successfully completing a SBT. Patients were randomly assigned to be interviewed during this trial regarding their prediction of extubation success. We compared post-extubation outcomes in three patient groups: patients confident (confidents; n = 115) or not (non-confidents; n = 38) of their extubation success and patients not subjected to interview (control group; n = 58).
RESULTS


Extubation success was more frequent in confidents than in non-confidents (90 vs. 45%; p < 0.001/positive likelihood ratio = 2.00) or in the control group (90 vs. 78%; p = 0.04). On the contrary, extubation failure was more common in non-confidents than in confidents (55 vs. 10%; p < 0.001/negative likelihood ratio = 0.19). Logistic regression analysis showed that extubation success was associated with patient's prediction [OR (95% CI): 9.2 (3.74-22.42) for confidents vs.non-confidents] as well as to age [0.72 (0.66-0.78) for age 75 vs. 65 and 1.31 (1.28-1.51) for age 55 vs. 65].
CONCLUSIONS


Our data suggest that at the end of a sustained SBT, extubation success might be correlated to the patients' subjective perception of autonomous breathing. The results of this study should be confirmed by a large multicenter trial.",2010,"RESULTS


Extubation success was more frequent in confidents than in non-confidents (90 vs. 45%; p < 0.001/positive likelihood ratio = 2.00) or in the control group (90 vs. 78%; p = 0.04).","['three patient groups: patients confident (confidents; n = 115) or not (non-confidents; n = 38) of their extubation success and patients not subjected to interview (control group; n = 58', '211 mechanically ventilated adult patients successfully completing a SBT']",[],"['extubation failure', 'Extubation success', 'extubation success']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0558095', 'cui_str': 'Confident (finding)'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",[],"[{'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",211.0,0.0643996,"RESULTS


Extubation success was more frequent in confidents than in non-confidents (90 vs. 45%; p < 0.001/positive likelihood ratio = 2.00) or in the control group (90 vs. 78%; p = 0.04).","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Perren', 'Affiliation': 'Intensive Care, Department of Intensive Care, Ente Ospedaliero Cantonale, Ospedale Regionale Bellinzona e Valli, 6500, Bellinzona, Switzerland. andreas.perren@eoc.ch'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Previsdomini', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Llamas', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Cerutti', 'Affiliation': ''}, {'ForeName': 'Sandor', 'Initials': 'S', 'LastName': 'Györik', 'Affiliation': ''}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Merlani', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Jolliet', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-010-1984-4']
1730,31578572,Beta-blockers in heart failure patients with severe chronic kidney disease-time for a randomized controlled trial?,,2020,,['heart failure patients with severe chronic kidney disease-time'],['Beta-blockers'],[],"[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0330390', 'cui_str': 'Beta (organism)'}]",[],,0.0510105,,"[{'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Department of Medicine, Division of Nephrology, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': 'University of Lorraine, Inserm 1433 CIC-P CHRU de Nancy, Inserm U1116 and FCRIN INI-CRCT, Nancy, France.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz187']
1731,31522033,Phase II randomised discontinuation trial of brivanib in patients with advanced solid tumours.,"BACKGROUND


Brivanib is a selective inhibitor of vascular endothelial growth factor and fibroblast growth factor (FGF) signalling. We performed a phase II randomised discontinuation trial of brivanib in 7 tumour types (soft-tissue sarcomas [STS], ovarian cancer, breast cancer, pancreatic cancer, non-small-cell lung cancer [NSCLC], gastric/esophageal cancer and transitional cell carcinoma [TCC]).
PATIENTS AND METHODS


During a 12-week open-label lead-in period, patients received brivanib 800 mg daily and were evaluated for FGF2 status by immunohistochemistry. Patients with stable disease at week 12 were randomised to brivanib or placebo. A study steering committee evaluated week 12 response to determine if enrolment in a tumour type would continue. The primary objective was progression-free survival (PFS) for brivanib versus placebo in patients with FGF2-positive tumours.
RESULTS


A total of 595 patients were treated, and stable disease was observed at the week 12 randomisation point in all tumour types. Closure decisions were made for breast cancer, pancreatic cancer, NSCLC, gastric cancer and TCC. Criteria for expansion were met for STS and ovarian cancer. In 53 randomised patients with STS and FGF2-positive tumours, the median PFS was 2.8 months for brivanib and 1.4 months for placebo (hazard ratio [HR]: 0.58, p = 0.08). For all randomised patients with sarcomas, the median PFS was 2.8 months (95% confidence interval [CI]: 1.4-4.0) for those treated with brivanib compared with 1.4 months (95% CI: 1.3-1.6) for placebo (HR = 0.64, 95% CI: 0.38-1.07; p = 0.09). In the 36 randomised patients with ovarian cancer and FGF2-positive tumours, the median PFS was 4.0 (95% CI: 2.6-4.2) months for brivanib and 2.0 months (95% CI: 1.2-2.7) for placebo (HR: 0.56, 95% CI: 0.26-1.22). For all randomised patients with ovarian cancer, the median PFS in those randomised to brivanib was 4.0 months (95% CI: 2.6-4.2) and was 2.0 months (95% CI: 1.2-2.7) in those randomised to placebo (HR = 0.54, 95% CI: 0.25-1.17; p = 0.11).
CONCLUSION


Brivanib demonstrated activity in STS and ovarian cancer with an acceptable safety profile. FGF2 expression, as defined in the protocol, is not a predictive biomarker of the efficacy of brivanib.",2019,"For all randomised patients with ovarian cancer, the median PFS in those randomised to brivanib was 4.0 months (95% CI: 2.6-4.2) and was 2.0 months (95% CI: 1.2-2.7) in those randomised to placebo (HR = 0.54, 95% CI: 0.25-1.17; p = 0.11).
","['Patients with stable disease at week 12', '595 patients', '36 randomised patients with ovarian cancer and FGF2-positive tumours', '7 tumour types (soft-tissue sarcomas\xa0[STS], ovarian cancer, breast cancer, pancreatic cancer, non-small-cell lung cancer [NSCLC], gastric/esophageal cancer\xa0and transitional cell carcinoma [TCC', '53 randomised patients with STS and FGF2-positive tumours', 'patients with FGF2-positive tumours', 'patients with advanced solid tumours']","['brivanib or placebo', 'brivanib', 'placebo', 'brivanib 800\xa0mg daily and were evaluated for FGF2 status by immunohistochemistry', 'brivanib versus placebo']","['progression-free survival (PFS', 'median PFS', 'FGF2 expression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0380603', 'cui_str': 'Prostate Epithelial Cell Growth Factor'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C4551687', 'cui_str': 'Sarcoma of soft tissue (disorder)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}, {'cui': 'C0007138', 'cui_str': 'Carcinoma, Transitional Cell'}, {'cui': 'C1098189', 'cui_str': 'tetrakis(2-amino-5-ethyl-1,3,4-thiadiazole-N3)chlorocopper(II) chloride'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]","[{'cui': 'C2700604', 'cui_str': 'brivanib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0380603', 'cui_str': 'Prostate Epithelial Cell Growth Factor'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0380603', 'cui_str': 'Prostate Epithelial Cell Growth Factor'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",595.0,0.421179,"For all randomised patients with ovarian cancer, the median PFS in those randomised to brivanib was 4.0 months (95% CI: 2.6-4.2) and was 2.0 months (95% CI: 1.2-2.7) in those randomised to placebo (HR = 0.54, 95% CI: 0.25-1.17; p = 0.11).
","[{'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Jones', 'Affiliation': 'Royal Marsden Hospital, Institute of Cancer Research, London, United Kingdom. Electronic address: robin.jones4@nhs.net.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Ratain', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': ""O'Dwyer"", 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Lillian L', 'Initials': 'LL', 'LastName': 'Siu', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, ON, USA.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Jassem', 'Affiliation': 'Medical University of Gdansk, Gdansk, Poland.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Medioni', 'Affiliation': 'Hôpital Européen Georges Pompidou, Paris, France; Paris-Descartes University, Paris, France.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'DeJonge', 'Affiliation': 'Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Rudin', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sawyer', 'Affiliation': 'Cross Cancer Institute, Edmonton, AB, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Khayat', 'Affiliation': 'Petrie-Salpetriere Hospital, Paris, France.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Awada', 'Affiliation': 'Institut Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'Judith M P G M', 'Initials': 'JMPGM', 'LastName': 'de Vos-Geelen', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology, GROW - School for Oncology and Developmental Biology, Maastricht UMC+, Maastricht, the Netherlands.'}, {'ForeName': 'T R Jeffry', 'Initials': 'TRJ', 'LastName': 'Evans', 'Affiliation': 'Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Obel', 'Affiliation': 'North Shore University Health System, Evanston, IL, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Brockstein', 'Affiliation': 'North Shore University Health System, Evanston, IL, USA.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'DeGreve', 'Affiliation': 'University Hospital Brussels, Brussels, Belgium.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Baurain', 'Affiliation': 'Centre du Cancer, Cu Saint-Luc/UCL, Brussels, Belgium.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Maki', 'Affiliation': 'Monter Cancer Center, Lake Success, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': ""D'Adamo"", 'Affiliation': 'Eisai Inc, Woodcliff Lake, NJ Previously Memorial Sloan-Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Dickson', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Undevia', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Geary', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Janisch', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Philippe L', 'Initials': 'PL', 'LastName': 'Bedard', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, ON, USA.'}, {'ForeName': 'Albiruni R', 'Initials': 'AR', 'LastName': 'Abdul Razak', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, ON, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kristeleit', 'Affiliation': 'Royal Marsden Hospital, Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Vitfell-Rasmussen', 'Affiliation': 'Royal Marsden Hospital, Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Walters', 'Affiliation': 'Intensity Therapeutics Inc, Westport, CT Previously BMS, USA.'}, {'ForeName': 'Stan B', 'Initials': 'SB', 'LastName': 'Kaye', 'Affiliation': 'Royal Marsden Hospital, Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Schwartz', 'Affiliation': 'Columbia University, New York, NY, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.07.024']
1732,20687619,Inactivated split-virion seasonal influenza vaccine (Fluarix): a review of its use in the prevention of seasonal influenza in adults and the elderly.,"Fluarix is a trivalent, inactivated, split-virion influenza vaccine containing 15 microg haemagglutinin from each of the three influenza virus strains (including an H1N1 influenza A virus subtype, an H3N2 influenza A virus subtype and an influenza B virus) that are expected to be circulating in the up-coming influenza season. Fluarix is highly immunogenic in healthy adults and elderly, and exceeds the criteria that make it acceptable for licensure in various regions (including the US and Europe). In a large, phase III, placebo-controlled, double-blind trial conducted in the US (2004/2005) in subjects aged 18-64 years, postvaccination seroconversion rates against the H1N1, H3N2 and B antigens were 60-78% and respective postvaccination seroprotection rates were 97-99% in Fluarix recipients. Another phase III trial conducted in the US (2005/2006) established the noninferiority of Fluarix versus another trivalent inactivated influenza virus vaccine in subjects aged >or=18 years, including a subgroup of elderly subjects. In annual European registration trials, Fluarix has consistently exceeded the immunogenicity criteria set by the EU Committee for Medicinal Products for Human Use for adults and the elderly. Fluarix demonstrated immunogenicity in small, open-label studies in at-risk subjects. During a year when the vaccine was well matched to the circulating strain, Fluarix demonstrated efficacy against culture-confirmed influenza A and/or B in a placebo-controlled trial in adults aged 18-64 years. In addition, Fluarix vaccination of pregnant women demonstrated efficacy in reducing the rate of laboratory-confirmed influenza in the infants and reducing febrile respiratory illnesses in the mothers and their new-born infants in a randomized trial. Fluarix was generally well tolerated in adults and the elderly in well designed clinical trials and in the annual European registration trials, with most local and general adverse events being transient and mild to moderate in intensity. The most common adverse reactions in recipients of Fluarix were pain, redness or swelling at the injection site, muscle aches, fatigue, headache and arthralgia. In conclusion, Fluarix is an important means of decreasing the impact of seasonal influenza viruses on adults and the elderly.",2010,"Fluarix was generally well tolerated in adults and the elderly in well designed clinical trials and in the annual European registration trials, with most local and general adverse events being transient and mild to moderate in intensity.","['subjects aged >or=18 years, including a subgroup of elderly subjects', 'pregnant women', 'adults aged 18-64 years', 'adults and the elderly', 'healthy adults and elderly']","['Fluarix versus another trivalent inactivated influenza virus vaccine', 'Fluarix', 'placebo', 'Inactivated split-virion seasonal influenza vaccine (Fluarix']","['postvaccination seroconversion rates against the H1N1, H3N2 and B antigens', 'febrile respiratory illnesses', 'postvaccination seroprotection rates', 'rate of laboratory-confirmed influenza', 'pain, redness or swelling at the injection site, muscle aches, fatigue, headache and arthralgia']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0591524', 'cui_str': 'fluarix'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042760', 'cui_str': 'Viral Particles'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course (qualifier value)'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0580264', 'cui_str': 'H1N1'}, {'cui': 'C0580267', 'cui_str': 'H3N2'}, {'cui': 'C0368721', 'cui_str': 'Blood group antigen B (substance)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0221208', 'cui_str': 'Injection site (morphologic abnormality)'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}]",,0.0378655,"Fluarix was generally well tolerated in adults and the elderly in well designed clinical trials and in the annual European registration trials, with most local and general adverse events being transient and mild to moderate in intensity.","[{'ForeName': 'Monique P', 'Initials': 'MP', 'LastName': 'Curran', 'Affiliation': 'Adis, a Wolters Kluwer Business, Mairangi Bay, North Shore, Auckland, New Zealand. demail@adis.co.nz'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Leroux-Roels', 'Affiliation': ''}]",Drugs,['10.2165/11205020-000000000-00000']
1733,31514107,Can radiomics help to predict skeletal muscle response to chemotherapy in stage IV non-small cell lung cancer?,"BACKGROUND


Muscle depletion negatively impacts treatment efficacy and survival rates in cancer. Prevention and timely treatment of muscle loss require prediction of patients at risk. We aimed to investigate the potential of skeletal muscle radiomic features to predict future muscle loss.
METHODS


A total of 116 patients with stage IV non-small cell lung cancer included in a randomised controlled trial (NCT01171170) studying the effect of nitroglycerin added to paclitaxel-carboplatin-bevacizumab were enrolled. In this post hoc analysis, muscle cross-sectional area and radiomic features were extracted from computed tomography images obtained before initiation of chemotherapy and shortly after administration of the second cycle. For internal cross-validation, the cohort was randomly split in a training set and validation set 100 times. We used least absolute shrinkage and selection operator method to select features that were most significantly associated with muscle loss and an area under the curve (AUC) for model performance.
RESULTS


Sixty-nine patients (59%) exhibited loss of skeletal muscle. One hundred ninety-three features were used to construct a prediction model for muscle loss. The average AUC was 0.49 (95% confidence interval [CI]: 0.36, 0.62). Differences in intensity and texture radiomic features over time were seen between patients with and without muscle loss.
CONCLUSIONS


The present study shows that skeletal muscle radiomics did not predict future muscle loss during chemotherapy in non-small cell lung cancer. Differences in radiomic features over time might reflect myosteatosis. Future imaging analysis combined with muscle tissue analysis in patients and in experimental models is needed to unravel the biological processes linked to the radiomic features.",2019,"The average AUC was 0.49 (95% confidence interval [CI]: 0.36, 0.62).","['patients at risk', '116 patients with stage IV non-small cell lung cancer', 'cancer', 'One hundred ninety-three features']",['nitroglycerin added to paclitaxel-carboplatin-bevacizumab'],"['muscle loss and an area under the curve (AUC', 'average AUC', 'loss of skeletal muscle', 'intensity and texture radiomic features']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}]","[{'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0449582', 'cui_str': 'With texture (attribute)'}]",193.0,0.130463,"The average AUC was 0.49 (95% confidence interval [CI]: 0.36, 0.62).","[{'ForeName': 'E E C', 'Initials': 'EEC', 'LastName': 'de Jong', 'Affiliation': 'The D-Lab: Decision Support for Precision Medicine, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'K J C', 'Initials': 'KJC', 'LastName': 'Sanders', 'Affiliation': 'Department of Respiratory Medicine, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Deist', 'Affiliation': 'The D-Lab: Decision Support for Precision Medicine, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'van Elmpt', 'Affiliation': 'Department of Radiation Oncology (MAASTRO Clinic), GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jochems', 'Affiliation': 'The D-Lab: Decision Support for Precision Medicine, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'van Timmeren', 'Affiliation': 'The D-Lab: Decision Support for Precision Medicine, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'R T H', 'Initials': 'RTH', 'LastName': 'Leijenaar', 'Affiliation': 'The D-Lab: Decision Support for Precision Medicine, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'J H R J', 'Initials': 'JHRJ', 'LastName': 'Degens', 'Affiliation': 'Department of Respiratory Medicine, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'A M W J', 'Initials': 'AMWJ', 'LastName': 'Schols', 'Affiliation': 'Department of Respiratory Medicine, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'A-M C', 'Initials': 'AC', 'LastName': 'Dingemans', 'Affiliation': 'Department of Respiratory Medicine, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lambin', 'Affiliation': 'The D-Lab: Decision Support for Precision Medicine, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands. Electronic address: philippe.lambin@maastrichtuniversity.nl.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.07.023']
1734,19770529,Hyoscine-B butyl bromide in labor: a randomized controlled trial.,,2009,,['labor'],['Hyoscine-B butyl bromide'],[],"[{'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}]","[{'cui': 'C0036442', 'cui_str': 'Scopolamine'}, {'cui': 'C0626372', 'cui_str': '1-bromobutane'}]",[],,0.189927,,"[{'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Jacob', 'Affiliation': ''}]",Indian journal of medical sciences,['10.4103/0019-5359.55890']
1735,32066548,The Role of Mobile Phone Camera Recordings in the Diagnosis of Meniere's Disease and Pathophysiological Implications.,"OBJECTIVES


This study aimed to understand if videos of the patients' nystagmus recorded by themselves during the attacks can help in the diagnosis of Meniere's disease (MD).
MATERIALS AND METHODS


Sixty patients (age range 32-78 years) who had vestibular attacks and hearing complaints admitted to Çukurova University Hospital Otolaryngology Department and a private office between September 2013 and January 2017 were included in this randomized clinical trial study. Two groups with 30 patients each were formed. The first group was asked to send eye-videos recorded during the attack, while the patients in the second group were followed with conventional methods. Twenty-six patients in the first group were able to send satisfactory eye movement videos; four patients were excluded due to repeated recording faults. Twenty-seven patients in the second group could be followed; three patients were lost to follow-up. The number of attacks and time needed to diagnose both groups were compared.
RESULTS


The video group could be diagnosed in a shorter period compared to the control group. The diagnosis was made within two attacks (38 days) in the video group and within four attacks (92 days) in the control group.
CONCLUSION


This study shows that cell phone camera recordings of nystagmus of the patients are very helpful to diagnose MD. These recordings can also be used as an adjunct to understand the pathophysiology of the disease.",2020,"The diagnosis was made within two attacks (38 days) in the video group and within four attacks (92 days) in the control group.
","['Twenty-six patients in the first group were able to send satisfactory eye movement videos; four patients were excluded due to repeated recording faults', 'Sixty patients (age range 32-78 years) who had vestibular attacks and hearing complaints admitted to Çukurova University Hospital Otolaryngology Department and a private office between September 2013 and January 2017']",['Mobile Phone Camera Recordings'],['number of attacks and time needed to diagnose'],"[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0029892', 'cui_str': 'Otorhinolaryngology'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}]","[{'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0179533', 'cui_str': 'Camera'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]",4.0,0.0271732,"The diagnosis was made within two attacks (38 days) in the video group and within four attacks (92 days) in the control group.
","[{'ForeName': 'Mete', 'Initials': 'M', 'LastName': 'Kıroğlu', 'Affiliation': 'Department of Otorhinolaryngology, Çukurova University School of Medicine, Adana, Turkey.'}, {'ForeName': 'Muhammed', 'Initials': 'M', 'LastName': 'Dağkıran', 'Affiliation': 'Department of Otorhinolaryngology, Çukurova University School of Medicine, Adana, Turkey.'}]",The journal of international advanced otology,['10.5152/iao.2019.6605']
1736,30614741,Erenumab for episodic migraine prophylaxis.,"Introduction : This paper reviews placebo-controlled randomized double-blind studies with erenumab for the prevention of migraine. Erenumab is a fully human monoclonal antibody (mAb), which specifically blocks the calcitonin gene-related peptide (GGRP) receptor.  Areas covered : This manuscript was based on articles written in English located on PubMed using the following search terms: episodic and chronic migraine, migraine prophylaxis and prevention, CGRP, CGRP receptor, CGRP receptor antagonist, erenumab, treatment failures, and trigeminal nerve.  Expert commentary : The primary endpoints in Phase II and III preventive episodic migraine trials have been reached successfully, and so have multiple secondary endpoints. Monthly subcutaneous injections of either erenumab 70 mg or 140 mg reduced mean monthly migraine days (MMDs) after 3 and 6 months significantly greater than placebo when compared to baseline values with an onset of action within the first week. About 50% of subjects have at least a 50% reduction of MMDs. Several patient-reported outcome measures demonstrate improved quality of life with erenumab. This antibody also shows efficacy in a prior preventive treatment failure population. The tolerability of erenumab is good, which is reflected by low dropout rates in all erenumab clinical trials. Within the first year of treatment, no specific group or type of adverse events were observed.",2019,"Erenumab is a fully human monoclonal antibody (mAb), which specifically blocks the calcitonin gene-related peptide (GGRP) receptor.  ",[],['placebo'],"['MMDs', 'adverse events', 'mean monthly migraine days (MMDs', 'quality of life with erenumab']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C4542165', 'cui_str': 'erenumab'}]",,0.0669902,"Erenumab is a fully human monoclonal antibody (mAb), which specifically blocks the calcitonin gene-related peptide (GGRP) receptor.  ","[{'ForeName': 'Lucas Hendrik', 'Initials': 'LH', 'LastName': 'Overeem', 'Affiliation': 'a Department of Neurology and Experimental Neurology , Charite - Universitatsmedizin , Berlin , Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Neeb', 'Affiliation': 'a Department of Neurology and Experimental Neurology , Charite - Universitatsmedizin , Berlin , Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Reuter', 'Affiliation': 'a Department of Neurology and Experimental Neurology , Charite - Universitatsmedizin , Berlin , Germany.'}]",Expert review of neurotherapeutics,['10.1080/14737175.2019.1565996']
1737,31455824,"Morphine compared to placebo for procedural pain in preterm infants: safety, efficacy and equipoise.",,2019,,['preterm infants'],"['placebo', 'Morphine']",[],"[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]",[],,0.11121,,"[{'ForeName': 'Omri David', 'Initials': 'OD', 'LastName': 'Soffer', 'Affiliation': ""Division of Newborn Medicine, Boston Children's Hospital, Boston, MA, USA. Omri.soffer@childrens.harvard.edu.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cornelissen', 'Affiliation': ""Division of Pain Medicine, Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Cummings', 'Affiliation': ""Division of Newborn Medicine, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Berde', 'Affiliation': ""Division of Pain Medicine, Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Boston, MA, USA.""}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0476-9']
1738,32017597,Pulse Wave Velocity in Chronic Obstructive Pulmonary Disease and the Impact of Inhaled Therapy (SUMMIT): A Randomized Double-Blind Clinical Trial.,,2020,,[],['Inhaled Therapy (SUMMIT'],[],[],"[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.735713,,"[{'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Crim', 'Affiliation': 'GlaxoSmithKline plcResearch Triangle Park, North Carolina.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Anderson', 'Affiliation': 'GlaxoSmithKline plcMiddlesex, United Kingdom.'}, {'ForeName': 'Peter M A', 'Initials': 'PMA', 'LastName': 'Calverley', 'Affiliation': 'University Hospital AintreeLiverpool, United Kingdom.'}, {'ForeName': 'Bartolome R', 'Initials': 'BR', 'LastName': 'Celli', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical SchoolBoston, Massachusetts.""}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Cowans', 'Affiliation': 'Veramed Ltd.Twickenham, United Kingdom.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Weill Cornell MedicineNew York, New York.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'University of EdinburghEdinburgh, United Kingdom.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Vestbo', 'Affiliation': 'The University of Manchester Manchester, United Kingdom.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Yates', 'Affiliation': 'GlaxoSmithKline plcResearch Triangle Park, North Carolina.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Brook', 'Affiliation': 'University of MichiganAnn Arbor, Michigan.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201908-1639LE']
1739,31535384,Effect of C1-inhibitor in adults with mild asthma: A randomized controlled trial.,,2020,,['adults with mild asthma'],['C1-inhibitor'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}]","[{'cui': 'C1446194', 'cui_str': 'Serum C1 inhibitor antigen measurement'}]",[],,0.248424,,"[{'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Center of Experimental and Molecular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Tjitske S R', 'Initials': 'TSR', 'LastName': 'van Engelen', 'Affiliation': 'Center of Experimental and Molecular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Bastiaan W', 'Initials': 'BW', 'LastName': 'Haak', 'Affiliation': 'Center of Experimental and Molecular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter I', 'Initials': 'PI', 'LastName': 'Bonta', 'Affiliation': 'Department of Respiratory Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Christof J', 'Initials': 'CJ', 'LastName': 'Majoor', 'Affiliation': 'Department of Respiratory Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Cornelis', 'Initials': 'C', 'LastName': ""van 't Veer"", 'Affiliation': 'Center of Experimental and Molecular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Alex F', 'Initials': 'AF', 'LastName': 'de Vos', 'Affiliation': 'Center of Experimental and Molecular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'E Marleen', 'Initials': 'EM', 'LastName': 'Kemper', 'Affiliation': 'Department of Pharmacy, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Lutter', 'Affiliation': 'Department of Experimental Immunology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'van Mierlo', 'Affiliation': 'Sanquin Research, Amsterdam, The Netherlands.'}, {'ForeName': 'Sacha S', 'Initials': 'SS', 'LastName': 'Zeerleder', 'Affiliation': 'Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Elisabeth H', 'Initials': 'EH', 'LastName': 'Bel', 'Affiliation': 'Department of Respiratory Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'van der Poll', 'Affiliation': 'Center of Experimental and Molecular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}]",Allergy,['10.1111/all.14053']
1740,18580613,Early virological suppression with three-class antiretroviral therapy in HIV-infected African infants.,"OBJECTIVES


Infants infected with HIV-1 perinatally despite single-dose nevirapine progress rapidly. Data on treatment outcome in sub-Saharan African infants exposed to single-dose nevirapine are urgently required. This feasibility study addresses efficacy of infant antiretroviral therapy in this setting.
METHODS


HIV-infected infants in Durban, South Africa, received randomized immediate or deferred (when CD4 cell count reached <20%) four-drug antiretroviral therapy (zidovudine/lamivudine/nelfinavir/nevirapine). Genotyping for non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance was undertaken pre-antiretroviral therapy. Monthly follow-up to 1-year post-antiretroviral therapy included viral load, CD4 cell count and verbal/measured adherence monitoring.
RESULTS


All 63 infants were exposed to single-dose nevirapine. Twenty-one out of 51 (39%) infants with baseline genotyping results had NNRTI resistance (most frequently Y181C; 20%). Forty-three infants were randomized to immediate antiretroviral therapy (ART): three withdrew pre-antiretroviral therapy; 36 out of 40 completed 1-year of ART. Twenty infants received deferred ART: 17 reached CD4 cell counts less than 20% (median d99) and 13 out of 17 started antiretroviral therapy in year 1. Verbal and measured adherence was 99% and 95%, respectively. One-year post-ART, 49 out of 49 (100%) infants had a viral load less than 400 copies/ml; 46 out of 49 (94%) had viral load less than 50 copies/ml. Ten infants (20%) required second-line ART due to virological failure or tuberculosis treatment, therefore 39 out of 49 (80%) achieved viral load less than 400 copies/ml by intention-to-treat. Time to viral load less than 50 copies/ml correlated with maternal CD4 cell count (r = -0.42; P = 0.005) and infant pre-ART viral load (r = 0.64; P < 0.001). NNRTI mutations had no significant effect on virological suppression. Infants starting immediate compared with deferred ART had fewer illness episodes (P = 0.003), but no significant difference in virological suppression.
CONCLUSION


Excellent adherence and virological suppression are achievable in infants, despite high-frequency NNRTI mutations and rapid disease progression. Infants remain relatively neglected in roll-out programmes and ART provision must be expanded.",2008,"Infants starting immediate compared with deferred ART had fewer illness episodes (P = 0.003), but no significant difference in virological suppression.
","['Forty-three infants', 'Twenty infants received', 'Infants infected with HIV-1 perinatally despite single-dose', 'HIV-infected African infants', 'sub-Saharan African infants', 'HIV-infected infants in Durban, South Africa']","['nevirapine', 'antiretroviral therapy (zidovudine/lamivudine/nelfinavir/nevirapine', 'deferred ART', 'immediate antiretroviral therapy (ART): three withdrew pre-antiretroviral therapy']","['CD4 cell counts', 'viral load less', 'virological suppression', 'maternal CD4 cell count', 'viral load, CD4 cell count and verbal/measured adherence monitoring', 'Verbal and measured adherence', 'NNRTI resistance', 'illness episodes', 'Excellent adherence and virological suppression']","[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0525005', 'cui_str': 'Nelfinavir'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]","[{'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}]",43.0,0.518457,"Infants starting immediate compared with deferred ART had fewer illness episodes (P = 0.003), but no significant difference in virological suppression.
","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Prendergast', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, UK. andy.prendergast@gmail.com'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Mphatswe', 'Affiliation': ''}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Tudor-Williams', 'Affiliation': ''}, {'ForeName': 'Mpho', 'Initials': 'M', 'LastName': 'Rakgotho', 'Affiliation': ''}, {'ForeName': 'Visva', 'Initials': 'V', 'LastName': 'Pillay', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Thobakgale', 'Affiliation': ''}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'McCarthy', 'Affiliation': ''}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Walker', 'Affiliation': ''}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Goulder', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0b013e32830437df']
1741,32119599,"Ten-Year Update of a Randomized, Prospective Trial of Conventional Fractionated Versus Moderate Hypofractionated Radiation Therapy for Localized Prostate Cancer.","PURPOSE


The previously published single institution randomized prospective trial failed to show superiority in the 5-year biochemical and/or clinical disease failure (BCDF) rate with moderate hypofractionated intensity-modulated radiation therapy (H-IMRT) versus conventionally fractionated IMRT (C-IMRT). We now present 10-year disease outcomes using updated risk groups and definitions of biochemical failure.
METHODS


Men with protocol-defined intermediate- and high-risk prostate adenocarcinoma were randomly assigned to receive C-IMRT (76 Gy in 38 fractions) or H-IMRT (70.2 Gy in 26 fractions). Men with high-risk disease were all prescribed 24 months of androgen deprivation therapy (ADT) and had lymph node irradiation. Men with intermediate risk were prescribed 4 months of ADT at the discretion of the treating physician. The primary endpoint was cumulative incidence of BCDF. We compared disease outcomes and overall mortality by treatment arm, with sensitivity analyses for National Comprehensive Cancer Network (NCCN) risk group adjustment.
RESULTS


Overall, 303 assessable men were randomly assigned to C-IMRT or H-IMRT. The median follow-up was 122.9 months. Per updated NCCN risk classification, there were 28 patients (9.2%) with low-risk, 189 (62.4%) with intermediate-risk, and 86 (28.4%) with high-risk prostate cancer. The arms were equally balanced for clinicopathologic factors, except that there were more black patients in the C-IMRT arm (17.8%  v  7.3%;  P  = .02). There was no difference in ADT use ( P  = .56). The 10-year cumulative incidence of BCDF was 25.9% in the C-IMRT arm and was 30.6% in the H-IMRT arm (hazard ratio, 1.31; 95% CI, 0.82 to 2.11). The two arms also had similar cumulative 10-year rates of biochemical failure, prostate cancer-specific mortality, and overall mortality; however, the 10-year cumulative incidence of distant metastases was higher in the H-IMRT arm (rate difference, 7.8%; 95% CI, 0.7% to 15.1%).
CONCLUSION


H-IMRT failed to demonstrate superiority compared with C-IMRT in long-term disease outcomes.",2020,"The two arms also had similar cumulative 10-year rates of biochemical failure, prostate cancer-specific mortality, and overall mortality; however, the 10-year cumulative incidence of distant metastases was higher in the H-IMRT arm (rate difference, 7.8%; 95% CI, 0.7% to 15.1%).
","['Men with protocol-defined intermediate- and high-risk prostate adenocarcinoma', 'Men with intermediate risk', 'Men with high-risk disease were all prescribed 24 months of androgen deprivation therapy (ADT) and had lymph node irradiation', 'Localized Prostate Cancer', '303 assessable men']","['C-IMRT or H-IMRT', 'Conventional Fractionated Versus Moderate Hypofractionated Radiation Therapy', 'C-IMRT', 'H-IMRT', 'moderate hypofractionated intensity-modulated radiation therapy (H-IMRT) versus conventionally fractionated IMRT (C-IMRT']","['disease outcomes and overall mortality', 'cumulative 10-year rates of biochemical failure, prostate cancer-specific mortality, and overall mortality', 'cumulative incidence of BCDF', '10-year cumulative incidence of BCDF', '10-year cumulative incidence of distant metastases', '5-year biochemical and/or clinical disease failure (BCDF) rate']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",303.0,0.150133,"The two arms also had similar cumulative 10-year rates of biochemical failure, prostate cancer-specific mortality, and overall mortality; however, the 10-year cumulative incidence of distant metastases was higher in the H-IMRT arm (rate difference, 7.8%; 95% CI, 0.7% to 15.1%).
","[{'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Avkshtol', 'Affiliation': 'Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Ruth', 'Affiliation': 'Department of Biostatistics, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Ross', 'Affiliation': 'Department of Biostatistics, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Hallman', 'Affiliation': 'Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Greenberg', 'Affiliation': 'Division of Urologic Oncology, Department of Surgical Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Price', 'Affiliation': 'Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Leachman', 'Affiliation': 'Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Uzzo', 'Affiliation': 'Division of Urologic Oncology, Department of Surgical Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Division of Urologic Oncology, Department of Surgical Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Geynisman', 'Affiliation': 'Division of Genitourinary Oncology, Department of Hematology and Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Sobczak', 'Affiliation': 'Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Eddie', 'Initials': 'E', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Wong', 'Affiliation': 'Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Pollack', 'Affiliation': 'Department of Radiation Oncology, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Horwitz', 'Affiliation': 'Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01485']
1742,19584487,The effect of clofibrate with phototherapy in late pre-term newborns with non-hemolytic jaundice.,"BACKGROUND


Despite an understanding of the enzymatic pathways leading to bilirubin production and degradation, very few pharmacologic interventions are utilized and the mainstay of treatment remains phototherapy.
AIMS


To evaluate the efficacy of clofibrate in reducing total serum bilirubin levels in late pre-term neonates with non-hemolytic jaundice.
DESIGN AND SETTING


Double-blind, placebo-controlled, randomized trial; tertiary level neonatal unit.
MATERIALS AND METHODS


A randomized controlled study was carried out in the neonatal ward of Children's Hospital, Tabriz, Iran, over a 1-year period. Sixty-eight healthy late pre-term infants readmitted with non-hemolytic hyperbilirubinemia were randomized to receive phototherapy and clofibrate (n= 35) or phototherapy and placebo (n= 33).
STATISTICAL ANALYSIS USED


Chi-square test and independent sample 't' test.
RESULTS


There were no significant differences in the weight, gender, modes of delivery and age of neonates between the two groups. Similarly the mean total serum bilirubin (TSB) level at the time of admission was not significantly different between the two groups [mean+/- SD: 19.72 +/- 1.79 (95% confidence interval: 19.12-20.54 mg/dL) vs. 20.05 +/- 2.82 (95% confidence interval, 19.54-22.04 mg/dL), P= 0.57]. The mean TSB 48 hours after phototherapy [mean+/- SD: 8.06+/- 1.34 (95% confidence interval: 7.94-10.18 mg/dL) vs.10.94 +/- 2.87 (95% confidence interval: 9.92-12.16 mg/dL), P= 0.02] and the mean duration of phototherapy [mean+/- SD: 64.32 +/- 12.48 (95% confidence interval: 60-81.6 hours) vs. 87.84 +/- 29.76 (95% confidence interval: 79.2-108 hours), P< 0.001] were significantly lower in the clofibrate-treated group.
CONCLUSIONS


Clofibrate is an effective adjunctive drug in neonatal hyperbilirubinemia, which results in decreased TSB level and reduced duration of phototherapy in late pre-term newborns.",2009,Similarly the mean total serum bilirubin (TSB) level at the time of admission was not significantly different between the two groups [mean+/- SD: 19.72 +/-,"['late pre-term neonates with non-hemolytic jaundice', ""neonatal ward of Children's Hospital, Tabriz, Iran, over a 1-year period"", '29.76', 'late pre-term newborns with non-hemolytic jaundice', 'Sixty-eight healthy late pre-term infants readmitted with non-hemolytic hyperbilirubinemia']","['phototherapy', 'placebo', 'Clofibrate', 'phototherapy and clofibrate (n= 35) or phototherapy and placebo', 'clofibrate', 'clofibrate with phototherapy']","['weight, gender, modes of delivery and age of neonates', 'mean duration of phototherapy', 'total serum bilirubin levels', 'TSB level and reduced duration of phototherapy', 'mean total serum bilirubin (TSB) level']","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0475409', 'cui_str': 'Non-hemolytic (qualifier value)'}, {'cui': 'C0022346', 'cui_str': 'Icterus'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}, {'cui': 'C0020433', 'cui_str': 'Bilirubinemia'}]","[{'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009002', 'cui_str': 'Clofibrate'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1287366', 'cui_str': 'Finding of serum bilirubin level (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.455533,Similarly the mean total serum bilirubin (TSB) level at the time of admission was not significantly different between the two groups [mean+/- SD: 19.72 +/-,"[{'ForeName': 'Sedigheh Hossein Pour', 'Initials': 'SH', 'LastName': 'Sakha', 'Affiliation': 'Department of Pediatrics, Tabriz University, Medical Sciences, Iran.'}, {'ForeName': 'Manizheh Mostafa', 'Initials': 'MM', 'LastName': 'Gharehbaghi', 'Affiliation': ''}, {'ForeName': 'Mohammad Ebrahim', 'Initials': 'ME', 'LastName': 'Rahbani', 'Affiliation': ''}]",Indian journal of medical sciences,['10.4103/0019-5359.53162']
1743,31524116,A low-fat diet up-regulates expression of fatty acid taste receptor gene  FFAR4  in fungiform papillae in humans: a co-twin randomised controlled trial.,"Fatty acid taste (FAT) perception is involved in the regulation of dietary fat intake, where impaired FAT is associated with increased fatty food intake. There are a number of FAT receptors identified on human taste cells that are potentially responsible for FAT perception. Manipulating dietary fat intake, and in turn FAT perception, would elucidate the receptors that are associated with long-term regulation of FAT perception. The present study aimed to assess associations between diet-mediated changes to FAT receptors and FAT perception in humans. A co-twin randomised controlled trial was conducted, where each matching twin within a pair were randomly allocated to either an 8-week low-fat (LF; <20 % energy fat) or an 8-week high-fat (HF; >35 % energy fat) diet. At baseline and week 8, fungiform papillae were biopsied in the fasted state and FAT receptor gene expressions (cluster of differentiation 36 (CD36), free fatty acid receptor 2 (FFAR2), FFAR4, G protein-coupled receptor 84 (GPR84) and a delayed rectifying K+ channel (K+ voltage-gated channel subfamily A member 2; KCNA2)) were measured using RT-PCR; and FAT threshold (FATT) was assessed using three-alternate forced choice methodology. Linear mixed models were fitted, adjusting for correlation between co-twins. Intake was compliant with the study design, with the LF and HF groups consuming 14·8 and 39·9 % energy from fat, respectively. Expression of FFAR4 increased by 38 % in the LF group (P = 0·023; time-diet interaction P = 0·063). ΔFFAR4 (Δ, week 8-baseline) was associated with Δfat intake (g) ( = -159·4; P < 0·001) and ΔFATT ( = -8·8; P = 0·016). In summary, FFAR4 is involved in long-term diet-mediated changes to FAT perception. Manipulating dietary fat intake, and therefore FFAR4 expression, might aid in reducing taste-mediated passive overconsumption of fatty foods.",2019,Expression of FFAR4 increased by 38% in the LF group (P=0.023; time-diet interaction P=0.063).,"['fungiform papillae in humans', 'humans']","['8-week low-fat (LF', 'Fatty acid taste (FAT) perception']",['Expression of FFAR4'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C2350521', 'cui_str': 'Gustatory Perception'}]","[{'cui': 'C3854321', 'cui_str': 'Expression'}]",,0.0304403,Expression of FFAR4 increased by 38% in the LF group (P=0.023; time-diet interaction P=0.063).,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Costanzo', 'Affiliation': 'School of Exercise and Nutrition Sciences, Centre for Advanced Sensory Science, Deakin University, Geelong, VIC 3220, Australia.'}, {'ForeName': 'Dongli', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'School of Exercise and Nutrition Sciences, Centre for Advanced Sensory Science, Deakin University, Geelong, VIC 3220, Australia.'}, {'ForeName': 'Caryl', 'Initials': 'C', 'LastName': 'Nowson', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Geelong, VIC 3220, Australia.'}, {'ForeName': 'Konsta', 'Initials': 'K', 'LastName': 'Duesing', 'Affiliation': 'Health & Biosecurity, Commonwealth Scientific and Industrial Research Organisation (CSIRO), North Ryde, NSW 2113, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Archer', 'Affiliation': 'Agriculture & Food, CSIRO, North Ryde, NSW 2113, Australia.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Bowe', 'Affiliation': 'Biostatistics Unit, Faculty of Health, Deakin University, Geelong, VIC 3220, Australia.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Keast', 'Affiliation': 'School of Exercise and Nutrition Sciences, Centre for Advanced Sensory Science, Deakin University, Geelong, VIC 3220, Australia.'}]",The British journal of nutrition,['10.1017/S0007114519002368']
1744,31651737,Optimizing Mycophenolic Acid Exposure in Kidney Transplant Recipients: Time for Target Concentration Intervention: Erratum.,,2019,,['Kidney Transplant Recipients'],['Mycophenolic Acid Exposure'],[],"[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}]","[{'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",[],,0.0118155,,[],Transplantation,['10.1097/TP.0000000000003001']
1745,31932097,Corrigendum to 'A nonrandomized controlled clinical pilot trial on 8 wk of intermittent fasting (24 h/wk)' Nutrition. 2018;46:143-152.e2.,,2020,,[],"[""Intermittent Fasting (24 H/Wk)' Nutrition""]",[],[],"[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]",[],,0.0312217,,"[{'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Kessler', 'Affiliation': 'Charité- Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, Germany; Immanuel Hospital Berlin, Department of Internal and Complementary Medicine, Berlin, Germany. Electronic address: c.kessler@immanuel.de.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Stange', 'Affiliation': 'Immanuel Hospital Berlin, Department of Internal and Complementary Medicine, Berlin, Germany.'}, {'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'Schlenkermann', 'Affiliation': 'Charité- Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jeitler', 'Affiliation': 'Charité- Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, Germany; Immanuel Hospital Berlin, Department of Internal and Complementary Medicine, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Michalsen', 'Affiliation': 'Charité- Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, Germany; Immanuel Hospital Berlin, Department of Internal and Complementary Medicine, Berlin, Germany.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Selle', 'Affiliation': 'Karl von Ossietzky University Oldenburg, Faculty V for Mathematics and Natural Sciences, Institute for Biology and Environmental Sciences, Oldenburg, Germany.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Raucci', 'Affiliation': 'IFOM FIRC Institute of Molecular Oncology, Milan, Italy.'}, {'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Steckhan', 'Affiliation': 'Charité- Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, Germany.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2019.110701']
1746,32024506,The youth concussion awareness network (You-CAN) - a school-based peer-led intervention to improve concussion reporting and social support: the protocol for a cluster randomized trial.,"BACKGROUND


Concussion prevalence is increasing in the pediatric population, and is a matter of public health concern. Concussion symptoms can be physical, cognitive, emotional and behavioural, and last longer in high school aged youth than adults. Concussions are underreported in youth due to their lack of knowledge, social environment, perceived outcomes of reporting, norms, and self-efficacy. The Youth Concussion Awareness Network (You-CAN) is a school-based peer-led program designed to increase high school students' intent to report a concussion, and provide social support to a peer. This study aims to investigate whether participation in You-CAN, a program grounded in service learning principles, impacts concussion knowledge, attitudes, intent to report a suspected concussion to an adult, and intent to provide social support to a peer. Secondary aims include assessing the implementation fidelity and acceptability of the intervention.
METHODS


This longitudinal study will use a cluster randomized trial design. Three high schools from six randomly selected Canadian school boards will participate and be randomized to three study arms: (1) You-CAN led by school staff; (2) You-CAN led by school staff and research team; and (3) untreated comparison group. Intervention arms 1 and 2 will deliver the You-CAN program and create a Concussion Council at their school. The Concussion Council will deliver a concussion awareness campaign and participate in an online showcase with other participating schools. In addition, arm 2 will have monthly video-calls with the research team. A survey based on the Theory of Planned Behaviour will be administered school-wide with all arms (1, 2, 3) at two time points (beginning {T 0 } and end {T 1 } of the school year). Exit interviews will be completed with the Concussion Councils and participating school staff.
DISCUSSION


This study will provide evidence of the effectiveness of a school-based peer-led concussion program on increasing concussion knowledge, attitudes, subjective norms, perceived behavioural control, intent to report a concussion to an adult, and intent to provide social support to a peer amongst Canadian high school students. It will also provide important information about the implementation and acceptability of the You-CAN program for high school students and staff.
TRIAL REGISTRATION


This trial is registered with the ISRCTN registry (ISRCTN64944275, 14/01/2020, retrospectively registered).",2020,"Concussion symptoms can be physical, cognitive, emotional and behavioural, and last longer in high school aged youth than adults.","['high school aged youth than adults', 'Canadian high school students']",['school-based peer-led concussion program'],['implementation fidelity and acceptability of the intervention'],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0006107', 'cui_str': 'Cerebral Concussion'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",6.0,0.033971,"Concussion symptoms can be physical, cognitive, emotional and behavioural, and last longer in high school aged youth than adults.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hickling', 'Affiliation': 'Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, Toronto, Canada.'}, {'ForeName': 'Kylie D', 'Initials': 'KD', 'LastName': 'Mallory', 'Affiliation': 'Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, Toronto, Canada.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Wilson', 'Affiliation': 'Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, Toronto, Canada.'}, {'ForeName': 'Rosephine', 'Initials': 'R', 'LastName': 'Del Fernandes', 'Affiliation': 'Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, Toronto, Canada.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Fuselli', 'Affiliation': 'Parachute, Toronto, Canada.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Reed', 'Affiliation': 'Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, Toronto, Canada. nick.reed@utoronto.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC public health,['10.1186/s12889-020-8244-5']
1747,4874894,Clinical trials of norcamphane hydrochloride in fatigue states. I. A double blind comparison with placebo and norcamphane vitamin combination.,,1967,,[],"['placebo and norcamphane vitamin combination', 'norcamphane hydrochloride']",[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0028339', 'cui_str': 'Norcamphanes'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}]",[],,0.36128,,"[{'ForeName': 'L P', 'Initials': 'LP', 'LastName': 'Shah', 'Affiliation': ''}, {'ForeName': 'V H', 'Initials': 'VH', 'LastName': 'Sethy', 'Affiliation': ''}, {'ForeName': 'V P', 'Initials': 'VP', 'LastName': 'Valame', 'Affiliation': ''}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Vaidya', 'Affiliation': ''}, {'ForeName': 'U K', 'Initials': 'UK', 'LastName': 'Sheth', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1748,18579976,"Role of hyoscine N-butyl bromide (HBB, buscopan) as labor analgesic.","BACKGROUND


Hyoscine N-butyl bromide (HBB) acts by inhibiting cholinergic transmission in the abdomino-pelvic parasympathetic ganglia, thus relieving spasm in the smooth muscles of gastrointestinal, biliary, urinary tract and female genital organs, especially the cervico-uterine plexus and aiding cervical dilatation.
AIM


The study was undertaken to observe the effects of 40 mg intravenous HBB as a labor analgesic and labor accelerant.
SETTINGS AND DESIGN


This prospective randomized control trial was carried out on 104 primigravidae with single live fetus in cephalic presentation, with spontaneous onset of labor, between 37-40 weeks of gestation.
MATERIALS AND METHODS


Women were consecutively randomized into study (group I) and control (group II) groups, each with 52 patients after excluding high risk factors like preeclampsia, antepartum hemorrhage, previous uterine scar, and any contraindications to vaginal delivery. Group I received 40 mg HBB as a slow intravenous injection in the active phase of labor while Group II received 2 mL normal saline. Pain scores were assessed at baseline and two hours later. Secondary outcome measures compared were progress of labor based on injection delivery interval, mode of delivery and neonatal condition at birth.
STATISTICAL ANALYSIS


Statistical significance was assessed by using Student's t-test and Chi-square test. P-value < 0.05 was taken as significant.
RESULTS


Pain relief of 35.6% was noted on visual analog score with the use of HBB. Mean duration of labor was 3 hours 46 minutes in Group I compared to 8 hours 16 minutes in Group II (P value: < 0.001). Mode of delivery and neonatal outcome were comparable. No adverse maternal effects were noted.
CONCLUSIONS


Intravenous Hyoscine N-Butyl Bromide causes pain relief of up to 36% and shortens the duration of active phase without any untoward short term fetal or maternal effects.",2008,"No adverse maternal effects were noted.
","['104 primigravidae with single live fetus in cephalic presentation, with spontaneous onset of labor, between 37-40 weeks of gestation', 'Women were consecutively randomized into study (group I) and control (group II) groups, each with 52 patients after excluding high risk factors like preeclampsia, antepartum hemorrhage, previous uterine scar, and any contraindications to vaginal delivery']","['40 mg intravenous HBB', 'labor while Group II received 2 mL normal saline', '40 mg HBB', 'Hyoscine N-butyl bromide (HBB', 'hyoscine N-butyl bromide (HBB, buscopan', 'Hyoscine N-Butyl Bromide']","['Pain relief', 'adverse maternal effects', 'Mean duration of labor', 'pain relief', 'progress of labor based on injection delivery interval, mode of delivery and neonatal condition at birth', 'Pain scores', 'visual analog score']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0015965', 'cui_str': 'Fetus'}, {'cui': 'C2979973'}, {'cui': 'C0474461', 'cui_str': 'Spontaneous onset of labor (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0269608', 'cui_str': 'Antepartum hemorrhage (disorder)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0426015', 'cui_str': 'Scarring of uterus (finding)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}, {'cui': 'C0626372', 'cui_str': '1-bromobutane'}, {'cui': 'C0701019', 'cui_str': 'Buscopan'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C4277511', 'cui_str': 'Maternal Inheritance'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor (observable entity)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0426273', 'cui_str': 'Neonatal condition (observable entity)'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",104.0,0.0649409,"No adverse maternal effects were noted.
","[{'ForeName': 'Pakhee', 'Initials': 'P', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Obstetrics and Gynaecology, Maulana Azad Medical College and Lok Nayak Hospital, New Delhi, India. pakh_ag@yahoo.com'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Zutshi', 'Affiliation': ''}, {'ForeName': 'Swaraj', 'Initials': 'S', 'LastName': 'Batra', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1749,31524498,"Dapagliflozin Effects on Biomarkers, Symptoms, and Functional Status in Patients With Heart Failure With Reduced Ejection Fraction: The DEFINE-HF Trial.","BACKGROUND


Outcome trials in patients with type 2 diabetes mellitus have demonstrated reduced hospitalizations for heart failure (HF) with sodium-glucose co-transporter-2 inhibitors. However, few of these patients had HF, and those that did were not well-characterized. Thus, the effects of sodium-glucose co-transporter-2 inhibitors in patients with established HF with reduced ejection fraction, including those with and without type 2 diabetes mellitus, remain unknown.
METHODS


DEFINE-HF (Dapagliflozin Effects on Biomarkers, Symptoms and Functional Status in Patients with HF with Reduced Ejection Fraction) was an investigator-initiated, multi-center, randomized controlled trial of HF patients with left ventricular ejection fraction ≤40%, New York Heart Association (NYHA) class II-III, estimated glomerular filtration rate ≥30 mL/min/1.73m 2 , and elevated natriuretic peptides. In total, 263 patients were randomized to dapagliflozin 10 mg daily or placebo for 12 weeks. Dual primary outcomes were (1) mean NT-proBNP (N-terminal pro b-type natriuretic peptide) and (2) proportion of patients with ≥5-point increase in HF disease-specific health status on the Kansas City Cardiomyopathy Questionnaire overall summary score, or a ≥20% decrease in NT-proBNP.
RESULTS


Patient characteristics reflected stable, chronic HF with reduced ejection fraction with high use of optimal medical therapy. There was no significant difference in average 6- and 12-week adjusted NT-proBNP with dapagliflozin versus placebo (1133 pg/dL (95% CI 1036-1238) vs 1191 pg/dL (95% CI 1089-1304),  P =0.43). For the second dual-primary outcome of a meaningful improvement in Kansas City Cardiomyopathy Questionnaire overall summary score or NT-proBNP, 61.5% of dapagliflozin-treated patients met this end point versus 50.4% with placebo (adjusted OR 1.8, 95% CI 1.03-3.06, nominal  P =0.039). This was attributable to both higher proportions of patients with ≥5-point improvement in Kansas City Cardiomyopathy Questionnaire overall summary score (42.9 vs 32.5%, adjusted OR 1.73, 95% CI 0.98-3.05), and ≥20% reduction in NT-proBNP (44.0 vs 29.4%, adjusted OR 1.9, 95% CI 1.1-3.3) by 12 weeks. Results were consistent among patients with or without type 2 diabetes mellitus, and other prespecified subgroups (all  P  values for interaction=NS).
CONCLUSIONS


In patients with heart failure and reduced ejection fraction, use of dapagliflozin over 12 weeks did not affect mean NT-proBNP but increased the proportion of patients experiencing clinically meaningful improvements in HF-related health status or natriuretic peptides. Benefits of dapagliflozin on clinically meaningful HF measures appear to extend to patients without type 2 diabetes mellitus.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT02653482.",2019,There was no significant difference in average 6- and 12-week adjusted NT-proBNP with dapagliflozin versus placebo (1133 pg/dL (95% CI 1036-1238) vs 1191 pg/dL,"['≥30', 'patients with established HF with reduced ejection fraction, including those with and without type 2 diabetes mellitus, remain unknown', 'Patients With Heart Failure', 'patients with type 2 diabetes mellitus', 'Patients with HF with Reduced Ejection Fraction) was an investigator-initiated, multi-center, randomized controlled trial of HF patients with left ventricular ejection fraction ≤40%, New York Heart Association (NYHA) class II-III, estimated glomerular filtration rate', 'patients without type 2 diabetes mellitus', '263 patients']","['dapagliflozin 10 mg daily or placebo', 'dapagliflozin', 'placebo', 'HF (Dapagliflozin', 'Dapagliflozin', 'sodium-glucose co-transporter-2 inhibitors']","['elevated natriuretic peptides', 'NT-proBNP', 'mean NT-proBNP', 'Kansas City Cardiomyopathy Questionnaire overall summary score', 'mean NT-proBNP (N-terminal pro b-type natriuretic peptide) and (2) proportion of patients with ≥5-point increase in HF disease-specific health status on the Kansas City Cardiomyopathy Questionnaire overall summary score', 'Kansas City Cardiomyopathy Questionnaire overall summary score or NT-proBNP', 'Biomarkers, Symptoms, and Functional Status', 'Ejection Fraction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C3811844'}, {'cui': 'C4517671', 'cui_str': '263'}]","[{'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}]","[{'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]",263.0,0.228944,There was no significant difference in average 6- and 12-week adjusted NT-proBNP with dapagliflozin versus placebo (1133 pg/dL (95% CI 1036-1238) vs 1191 pg/dL,"[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Nassif', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (M.E.N., S.L.W., F.T., Y.K., B.A., M.K.).""}, {'ForeName': 'Sheryl L', 'Initials': 'SL', 'LastName': 'Windsor', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (M.E.N., S.L.W., F.T., Y.K., B.A., M.K.).""}, {'ForeName': 'Fengming', 'Initials': 'F', 'LastName': 'Tang', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (M.E.N., S.L.W., F.T., Y.K., B.A., M.K.).""}, {'ForeName': 'Yevgeniy', 'Initials': 'Y', 'LastName': 'Khariton', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (M.E.N., S.L.W., F.T., Y.K., B.A., M.K.).""}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'Toronto General Hospital Research Institute, University Health Network, Toronto, Canada (M.H.).'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Yale University School of Medicine, New Haven, CT (S.E.I.).'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas (D.K.M., M.H.D.).'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'University of Michigan School of Medicine, Ann Arbor (B.P.).'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Scirica', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (B.M.S., M.M.G.).""}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Austin', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (M.E.N., S.L.W., F.T., Y.K., B.A., M.K.).""}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Drazner', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas (D.K.M., M.H.D.).'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Fong', 'Affiliation': 'Keck School of Medicine of USC, University of Southern California, Los Angeles (M.W.F.).'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Givertz', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (B.M.S., M.M.G.).""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Gordon', 'Affiliation': 'NorthShore University, Evanston, IL (R.A.G.).'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Jermyn', 'Affiliation': 'St. Francis Hospital, Roslyn, NY (R.J.).'}, {'ForeName': 'Stuart D', 'Initials': 'SD', 'LastName': 'Katz', 'Affiliation': 'New York University Langone Health, New York (S.D.K.).'}, {'ForeName': 'Sumant', 'Initials': 'S', 'LastName': 'Lamba', 'Affiliation': 'First Coast Cardiovascular Institute, Jacksonville, FL (S.L.).'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Lanfear', 'Affiliation': 'Henry Ford Hospital, Detroit, MI (D.E.L.).'}, {'ForeName': 'Shane J', 'Initials': 'SJ', 'LastName': 'LaRue', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO (S.J.L.).'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Lindenfeld', 'Affiliation': 'Vanderbilt University, Nashville, TN (J.L.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Malone', 'Affiliation': 'Charlotte Heart Group Research Center, Port Charlotte, FL (M.M.).'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Margulies', 'Affiliation': 'University of Pennsylvania, Philadelphia (K.M.).'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke University, Durham, NC (R.J.M.).'}, {'ForeName': 'R Kannan', 'Initials': 'RK', 'LastName': 'Mutharasan', 'Affiliation': 'Northwestern University, Chicago, IL (R.K.M.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pursley', 'Affiliation': 'Heart Group of the Eastern Shore, Fairhope, AL (M.P.).'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Umpierrez', 'Affiliation': 'Emory University, Atlanta, GA (G.U.).'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (M.E.N., S.L.W., F.T., Y.K., B.A., M.K.).""}]",Circulation,['10.1161/CIRCULATIONAHA.119.042929']
1750,31343477,Ultrasonographic Detection of Micro-Bubbles in the Right Atrium to Confirm Peripheral Venous Catheter Position in Children.,"OBJECTIVES


In pediatric patients, indwelling peripheral venous catheters are sometimes displaced to extravascular positions, causing infiltration or extravasation. No reliable techniques are available to confirm accurate IV catheterization. However, ultrasonographic detection of micro-bubble turbulence in the right atrium after saline injection has been reported to be useful in confirming central venous catheter positions in both adults and children. This study evaluated whether this micro-bubble detection test can offer better confirmation of peripheral venous catheter positions compared with the smooth saline injection technique in pediatric patients.
DESIGN


Randomized controlled study.
SETTING


Single tertiary PICU.
PATIENTS


Pediatric patients (weighing < 15 kg) who already had or required a peripheral venous catheter.
INTERVENTIONS


Patients were randomly allocated to either of the two groups (150 patients per group): undergoing either the micro-bubble detection test (M group) or the smooth saline injection test (S group).
MEASUREMENTS AND MAIN RESULTS


The peripheral venous catheters were confirmed to be IV located in the final position in 137 and 139 patients in the M and S groups, respectively. In properly located catheters, the tests were positive in 100% (n = 137/137; sensitivity, 100%; 95% CI, 97.8-100), and in 89% (n = 124/139; 95% CI, 82.8-93.8) of the M and S groups, respectively (p = 0.0001). Among the catheters located in extravascular positions, the tests were negative in 100% (n = 13/13; specificity, 100%; 95% CI, 79.4-100), and in 64% (n = 7/11; 95% CI, 30.8-89.1) of the M and S groups, respectively (p = 0.017).
CONCLUSIONS


The micro-bubble detection test is a useful technique for detecting extravasation and confirming proper positioning of peripheral IV catheters in pediatric patients.",2019,"In properly located catheters, the tests were positive in 100% (n = 137/137; sensitivity, 100%; 95% CI, 97.8-100), and in 89% (n = 124/139; 95% CI, 82.8-93.8) of the M and S groups, respectively (p = 0.0001).","['Pediatric patients (weighing < 15 kg) who already had or required a peripheral venous catheter', 'pediatric patients', 'Children']","['smooth saline injection technique', 'micro-bubble detection test (M group) or the smooth saline injection test (S group']","['Ultrasonographic Detection of Micro-Bubbles', 'peripheral venous catheters']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0745442', 'cui_str': 'Venous catheter (physical object)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0205357', 'cui_str': 'Smooth (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C2960425', 'cui_str': 'Injection technique'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0745442', 'cui_str': 'Venous catheter (physical object)'}]",150.0,0.0709005,"In properly located catheters, the tests were positive in 100% (n = 137/137; sensitivity, 100%; 95% CI, 97.8-100), and in 89% (n = 124/139; 95% CI, 82.8-93.8) of the M and S groups, respectively (p = 0.0001).","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takeshita', 'Affiliation': ""Department of Intensive Care Medicine, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Yasufumi', 'Initials': 'Y', 'LastName': 'Nakajima', 'Affiliation': 'Department of Anesthesiology, Kansai Medical University Hospital, Hirakata, Osaka, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kawamura', 'Affiliation': ""Department of Intensive Care Medicine, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Taniguchi', 'Affiliation': ""Department of Intensive Care Medicine, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': ""Department of Intensive Care Medicine, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Muneyuki', 'Initials': 'M', 'LastName': 'Takeuchi', 'Affiliation': ""Department of Intensive Care Medicine, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Shime', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Institute of Biomedical & Health Sciences, Hiroshima University, Minami-ku, Hiroshima, Japan.'}]",Critical care medicine,['10.1097/CCM.0000000000003916']
1751,31038276,Impact of haemostatic sealant versus electrocoagulation on ovarian reserve after laparoscopic ovarian cystectomy of ovarian endometriomas: a randomised controlled trial.,"OBJECTIVE


To evaluate the effect of haemostatic sealant compared with bipolar coagulation on ovarian reserve after laparoscopic cystectomy for ovarian endometriomas.
DESIGN


Patient-blinded, randomised controlled trial.
SETTING


University-affiliated tertiary hospital.
POPULATION


Women aged 18-40 years with 3-8 cm unilateral or bilateral endometriomas.
METHODS


Ninety-four patients were randomised to receive haemostasis by the application of haemostatic sealant (n = 47) or standard care (n = 47).
MAIN OUTCOME MEASURES


Primary outcome was the effect on the antral follicular count 3 months after the operation as it captures the effect on the ovary subjected to treatment. Secondary outcomes included the change in anti-Mullerian hormone, follicular-stimulating hormone and peri-operative outcomes including haemostasis, complications, pain, and satisfaction scores.
RESULTS


A total of 94 patients aged 32.36 ± 4.92 years underwent laparoscopic cystectomy for ovarian endometriomas. The average diameter of the endometrioma was 4.21 ± 1.38 cm. The increase in antral follicle count of the affected ovaries at 3 months in the intervention group (+2.36 ± 0.37) was significantly (P = 0.013) higher than that in the control group (+1.08 ± 0.36). Repeated measures analysis of variance revealed significant effect with time (P < 0.001) and of interaction of group × time (P = 0.029) for affected ovary antral follicle count. No significant difference was noted between the two groups with regard to follicular-stimulating hormone, anti-Mullerian hormone, and other secondary outcomes.
CONCLUSIONS


Applying haemostatic sealant after laparoscopic cystectomy of ovarian endometriomas produced a greater increase in antral follicle count 3 months after surgery compared with the control group.
TWEETABLE ABSTRACT


RCT: Haemostatic sealant in laparoscopic cystectomy of endometriomas increase in the antral follicle count after surgery.",2019,"No significant difference was noted between the two groups with regard to follicular-stimulating hormone, anti-Mullerian hormone, and other secondary outcomes.
","['Ninety-four patients', 'ovarian reserve after laparoscopic ovarian cystectomy of ovarian endometriomas', 'University-affiliated tertiary hospital', '94 patients aged 32.36\xa0±\xa04.92\xa0years underwent', 'for ovarian endometriomas', 'Women aged 18-40\xa0years with 3-8\xa0cm unilateral or bilateral endometriomas']","['laparoscopic cystectomy', 'bipolar coagulation', 'haemostatic sealant versus electrocoagulation', 'Haemostatic sealant', 'haemostatic sealant', 'haemostatic sealant (n\xa0=\xa047) or standard care']","['antral follicle count', 'change in anti-Mullerian hormone, follicular-stimulating hormone and peri-operative outcomes including haemostasis, complications, pain, and satisfaction scores', 'antral follicular count', 'ovarian reserve']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0195488', 'cui_str': 'Removal of ovarian cyst (procedure)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0010651', 'cui_str': 'Cystectomy'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C1261530', 'cui_str': 'Sealant (substance)'}, {'cui': 'C0013804', 'cui_str': 'Surgical Diathermy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0066928', 'cui_str': 'Anti-Muellerian Hormone'}, {'cui': 'C0439682', 'cui_str': 'Follicular (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}]",94.0,0.371442,"No significant difference was noted between the two groups with regard to follicular-stimulating hormone, anti-Mullerian hormone, and other secondary outcomes.
","[{'ForeName': 'Jpw', 'Initials': 'J', 'LastName': 'Chung', 'Affiliation': 'Department of Obstetrics and Gynaecology, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong, SAR.'}, {'ForeName': 'Tsm', 'Initials': 'T', 'LastName': 'Law', 'Affiliation': 'Department of Obstetrics and Gynaecology, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong, SAR.'}, {'ForeName': 'Chs', 'Initials': 'C', 'LastName': 'Chung', 'Affiliation': 'Department of Obstetrics and Gynaecology, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong, SAR.'}, {'ForeName': 'Jsm', 'Initials': 'J', 'LastName': 'Mak', 'Affiliation': 'Department of Obstetrics and Gynaecology, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong, SAR.'}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Sahota', 'Affiliation': 'Department of Obstetrics and Gynaecology, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong, SAR.'}, {'ForeName': 'T C', 'Initials': 'TC', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong, SAR.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.15807']
1752,19414982,"The effects of short-term, rapid glycemic control on the peroneal nerve function and serum VCAM-1 and AGE in type 2 diabetic patients in Malaysia.","BACKGROUND


The role of endothelial injury and circulating adhesion molecule in the development and progression of diabetic peripheral neuropathy in the long-term has been established previously.
AIMS


To study the effects of short-term glycemic control using insulin and oral hypoglycemic agent therapy (OHA) on the peroneal nerve function and vascular cell adhesion molecule-1 (VCAM-1) and advanced glycation endproducts (AGE) levels in type 2 diabetic patients.
SETTINGS AND DESIGN


A randomized controlled study involving poorly controlled (HbA1c, 7.5%-11%) type 2 diabetic patients attending the endocrinology outpatient center in a tertiary hospital in Kuala Lumpur.
MATERIALS AND METHODS


Twenty-nine patients were randomized to receive insulin (n=15) or OHA (n=14) for 8 weeks. The glycemic variables (HbA1c, fasting plasma glucose [FPG], fructosamine), VCAM-1, serum AGE and the peroneal motor conduction velocity (PMCV) were measured at baseline and at 4-week intervals.
STATISTICAL ANALYSIS USED


Paired 't' test or Kruskal Wallis test; and the unpaired 't' test or Mann-Whitney U test were used for within-group and between-group analyses, respectively. Correlation was analyzed using Spearman's correlation coefficient.
RESULTS


Within-group analysis showed significant progressive improvement in HbA1c at weeks 4 and 8 in the insulin group. The PMCV improved significantly in both groups by week 8, and by week 4 (P = 0.01) in the insulin group. PMCV correlated negatively with VCAM-1 (P = 0.031) and AGE (P = 0.009) at week 8.
CONCLUSION


Aggressive glycemic control with insulin improves the peroneal nerve function within 4 weeks. Improvement in the serum VCAM-1 and AGE levels correlated significantly with improvement in peroneal nerve conduction velocity only in the insulin group.",2009,Improvement in the serum VCAM-1 and AGE levels correlated significantly with improvement in peroneal nerve conduction velocity only in the insulin group.,"['type 2 diabetic patients', 'poorly controlled (HbA1c, 7.5%-11%) type 2 diabetic patients attending the endocrinology outpatient center in a tertiary hospital in Kuala Lumpur', 'Twenty-nine patients', 'type 2 diabetic patients in Malaysia']","['OHA', 'short-term, rapid glycemic control', 'short-term glycemic control using insulin and oral hypoglycemic agent therapy (OHA', 'insulin']","['PMCV', 'peroneal nerve function', 'peroneal nerve function and vascular cell adhesion molecule-1 (VCAM-1) and advanced glycation endproducts (AGE) levels', 'peroneal nerve function and serum VCAM-1 and AGE', 'peroneal nerve conduction velocity', 'glycemic variables (HbA1c, fasting plasma glucose [FPG], fructosamine), VCAM-1, serum AGE and the peroneal motor conduction velocity (PMCV', 'progressive improvement in HbA1c', 'serum VCAM-1 and AGE levels']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0299555', 'cui_str': 'PMCV (vaccine)'}, {'cui': 'C4316912', 'cui_str': 'Fibular Nerve'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation Endproducts'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0234084', 'cui_str': 'Conduction rate of nerve cell and nerve fiber, function (observable entity)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0060765', 'cui_str': 'D-Isoglucosamine'}, {'cui': 'C0442035', 'cui_str': 'Peroneal (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}]",29.0,0.0519213,Improvement in the serum VCAM-1 and AGE levels correlated significantly with improvement in peroneal nerve conduction velocity only in the insulin group.,"[{'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Norlinah', 'Affiliation': 'Department of Medicine, Universiti Kebangsaan Malaysia Medical Center (UKMMC), Kuala Lumpur, Malaysia. norlinah@mail.hukm.ukm.my'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hamizah', 'Affiliation': ''}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Md Isa', 'Affiliation': ''}, {'ForeName': 'W M', 'Initials': 'WM', 'LastName': 'Wan Nazaimoon', 'Affiliation': ''}, {'ForeName': 'B A K', 'Initials': 'BA', 'LastName': 'Khalid', 'Affiliation': ''}]",Indian journal of medical sciences,['10.4103/0019-5359.49365']
1753,18418571,Internally coated endotracheal tubes with silver sulfadiazine in polyurethane to prevent bacterial colonization: a clinical trial.,"OBJECTIVE


Coated medical devices have been shown to reduce catheter-related infections. We coated endotracheal tubes (ETT) with silver sulfadiazine (SSD), and tested them in a clinical study to assess the feasibility, safety, and efficacy of preventing bacterial colonization.
DESIGN


A prospective, randomized clinical trial, phase I-II.
SETTING


Academic intensive care unit (ICU).
PARTICIPANTS


Forty-six adult patients expected to need 12-24 h of intubation were randomized into two groups.
INTERVENTIONS


Patients were randomized to be intubated with a standard non-coated ETT (St-ETT, n=23; control group), or with a SSD-coated ETT (SSD-ETT, n=23).
MEASUREMENTS AND RESULTS


Coating with SSD prevented bacterial colonization of the ETT (frequency of colonization: SSD-ETT 0/23, St-ETT 8/23; p<0.01). No organized bacterial biofilm could be identified on the lumen of any ETT; however, SSD was associated with a thinner mucus layer (in the SSD-ETT secretion deposits ranged from 0 to 200 microm; in the St-ETT deposits ranged between 50 and 700 microm). No difference was observed between the two groups in the tracheobronchial brush samples (frequency of colonization: SSD-ETT 0/23, St-ETT 2/23; p=0.48). No adverse reactions were observed with the implementation of the novel device.
CONCLUSION


SSD-ETT can be safely used in preventing bacterial colonization and narrowing of the ETT in patients intubated for up to 24 h (mean intubation time 16 h).",2008,SSD-ETT can be safely used in preventing bacterial colonization and narrowing of the ETT in patients intubated for up to 24 h (mean intubation time 16 h).,"['Forty-six adult patients expected to need 12-24 h of intubation', 'Academic intensive care unit (ICU']","['SSD-coated ETT (SSD-ETT, n=23', 'coated endotracheal tubes (ETT) with silver sulfadiazine (SSD', 'silver sulfadiazine', 'standard non-coated ETT']","['bacterial colonization of the ETT (frequency of colonization', 'feasibility, safety, and efficacy', 'adverse reactions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0723179', 'cui_str': 'SSD'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube, device (physical object)'}, {'cui': 'C0037134', 'cui_str': 'silver sulfadiazine'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C2747813', 'cui_str': 'Bacterial colonisation'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",46.0,0.0254251,SSD-ETT can be safely used in preventing bacterial colonization and narrowing of the ETT in patients intubated for up to 24 h (mean intubation time 16 h).,"[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Berra', 'Affiliation': 'Anesthesia and Critical Care, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Boston, MA 02114, USA. lberra@partners.org'}, {'ForeName': 'Theodor', 'Initials': 'T', 'LastName': 'Kolobow', 'Affiliation': ''}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Laquerriere', 'Affiliation': ''}, {'ForeName': 'Betsey', 'Initials': 'B', 'LastName': 'Pitts', 'Affiliation': ''}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Bramati', 'Affiliation': ''}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Pohlmann', 'Affiliation': ''}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Marelli', 'Affiliation': ''}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Panzeri', 'Affiliation': ''}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Brambillasca', 'Affiliation': ''}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Villa', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Baccarelli', 'Affiliation': ''}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Bouthors', 'Affiliation': ''}, {'ForeName': 'Henry T', 'Initials': 'HT', 'LastName': 'Stelfox', 'Affiliation': ''}, {'ForeName': 'Luca M', 'Initials': 'LM', 'LastName': 'Bigatello', 'Affiliation': ''}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Moss', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pesenti', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-008-1100-1']
1754,20854770,Depressive symptoms and clinical status during the Treatment of Adolescent Suicide Attempters (TASA) Study.,"OBJECTIVE


To examine the course of depression during the treatment of adolescents with depression who had recently attempted suicide.
METHOD


Adolescents (N = 124), ages 12 to 18 years, with a 90-day history of suicide attempt, a current diagnosis of depressive disorder (96.0% had major depressive disorder), and a Children's Depression Rating Scale-Revised (CDRS-R) score of 36 or higher, entered a 6-month treatment with antidepressant medication, cognitive-behavioral therapy focused on suicide prevention, or their combination (Comb), at five academic sites. Treatment assignment could be either random or chosen by study participants. Intent-to-treat, mixed effects regression models of depression and other relevant ratings were estimated. Improvement and remission rates were computed with the last observation carried forward.
RESULTS


Most patients (n = 104 or 84%) chose treatment assignment, and overall, three fourths (n = 93) received Comb. In Comb, CDRS-R declined from a baseline adjusted mean of 49.6 (SD 12.3) to 38.3 (8.0) at week 12 and to 27.0 (10.1) at week 24 (p < .0001), with a Clinical Global Impression -defined improvement rate of 58.0% at week 12 and 72.2% at week 24 and a remission (CDRS-R ≤ 28) rate of 32.5% at week 12 and 50.0% at week 24. The CDRS-R and the Scale for Suicidal Ideation scores were correlated at baseline (r = 0.43, p < .0001) and declined in parallel.
CONCLUSIONS


When vigorously treated with a combination of medication and psychotherapy, adolescents with depression who have recently attempted suicide show rates of improvement and remission of depression that seem comparable to those observed in nonsuicidal adolescents with depression.",2009,"The CDRS-R and the Scale for Suicidal Ideation scores were correlated at baseline (r = 0.43, p < .0001) and declined in parallel.
","['adolescents with depression who had recently attempted suicide', ""Adolescents (N = 124), ages 12 to 18 years, with a 90-day history of suicide attempt, a current diagnosis of depressive disorder (96.0% had major depressive disorder), and a Children's Depression Rating Scale-Revised (CDRS-R) score of 36 or higher, entered a 6-month treatment with antidepressant medication, cognitive-behavioral therapy focused on suicide prevention, or their combination (Comb), at five academic sites""]",[],"['Depressive symptoms and clinical status', 'CDRS-R and the Scale for Suicidal Ideation scores', 'Clinical Global Impression -defined improvement rate', 'Improvement and remission rates']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0204732', 'cui_str': 'Suicide prevention (procedure)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0449440', 'cui_str': 'Clinical status (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",124.0,0.0491686,"The CDRS-R and the Scale for Suicidal Ideation scores were correlated at baseline (r = 0.43, p < .0001) and declined in parallel.
","[{'ForeName': 'Benedetto', 'Initials': 'B', 'LastName': 'Vitiello', 'Affiliation': 'Drs. Vitiello and Wagner are with the National Institute of Mental Health; Drs. Brent, Bukstein, and Goldstein, and Ms. Zelazny are with the University of Pittsburgh Western Psychiatnc Institute and Clinic; Drs. Greenhill Stanley, Posner, Shen, and Turner, and Ms. Gugga and Ms. Capasso are with the Columbia University-New York State Psychiatric Institute; Drs. Emslie and Kennard, and Ms. Mayes are with the University of Texas Southwestern Medical Center in Dallas; Drs. Wells, Compton, Curry, and March are with the Duke University Medical Center; Dr. Coffey is with the New York University Child Study Center; Drs. Walkup, Cwik, Barnett, and Riddle are with Johns Hopkins University. Electronic address: bvitiell@mail.nih.gov.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Brent', 'Affiliation': 'Drs. Vitiello and Wagner are with the National Institute of Mental Health; Drs. Brent, Bukstein, and Goldstein, and Ms. Zelazny are with the University of Pittsburgh Western Psychiatnc Institute and Clinic; Drs. Greenhill Stanley, Posner, Shen, and Turner, and Ms. Gugga and Ms. Capasso are with the Columbia University-New York State Psychiatric Institute; Drs. Emslie and Kennard, and Ms. Mayes are with the University of Texas Southwestern Medical Center in Dallas; Drs. Wells, Compton, Curry, and March are with the Duke University Medical Center; Dr. Coffey is with the New York University Child Study Center; Drs. Walkup, Cwik, Barnett, and Riddle are with Johns Hopkins University.'}, {'ForeName': 'Laurence L', 'Initials': 'LL', 'LastName': 'Greenhill', 'Affiliation': 'Drs. Vitiello and Wagner are with the National Institute of Mental Health; Drs. Brent, Bukstein, and Goldstein, and Ms. Zelazny are with the University of Pittsburgh Western Psychiatnc Institute and Clinic; Drs. Greenhill Stanley, Posner, Shen, and Turner, and Ms. Gugga and Ms. Capasso are with the Columbia University-New York State Psychiatric Institute; Drs. Emslie and Kennard, and Ms. Mayes are with the University of Texas Southwestern Medical Center in Dallas; Drs. Wells, Compton, Curry, and March are with the Duke University Medical Center; Dr. Coffey is with the New York University Child Study Center; Drs. Walkup, Cwik, Barnett, and Riddle are with Johns Hopkins University.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Emslie', 'Affiliation': 'Drs. Vitiello and Wagner are with the National Institute of Mental Health; Drs. Brent, Bukstein, and Goldstein, and Ms. Zelazny are with the University of Pittsburgh Western Psychiatnc Institute and Clinic; Drs. Greenhill Stanley, Posner, Shen, and Turner, and Ms. Gugga and Ms. Capasso are with the Columbia University-New York State Psychiatric Institute; Drs. Emslie and Kennard, and Ms. Mayes are with the University of Texas Southwestern Medical Center in Dallas; Drs. Wells, Compton, Curry, and March are with the Duke University Medical Center; Dr. Coffey is with the New York University Child Study Center; Drs. Walkup, Cwik, Barnett, and Riddle are with Johns Hopkins University.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Wells', 'Affiliation': 'Drs. Vitiello and Wagner are with the National Institute of Mental Health; Drs. Brent, Bukstein, and Goldstein, and Ms. Zelazny are with the University of Pittsburgh Western Psychiatnc Institute and Clinic; Drs. Greenhill Stanley, Posner, Shen, and Turner, and Ms. Gugga and Ms. Capasso are with the Columbia University-New York State Psychiatric Institute; Drs. Emslie and Kennard, and Ms. Mayes are with the University of Texas Southwestern Medical Center in Dallas; Drs. Wells, Compton, Curry, and March are with the Duke University Medical Center; Dr. Coffey is with the New York University Child Study Center; Drs. Walkup, Cwik, Barnett, and Riddle are with Johns Hopkins University.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Walkup', 'Affiliation': 'Drs. Vitiello and Wagner are with the National Institute of Mental Health; Drs. Brent, Bukstein, and Goldstein, and Ms. Zelazny are with the University of Pittsburgh Western Psychiatnc Institute and Clinic; Drs. Greenhill Stanley, Posner, Shen, and Turner, and Ms. Gugga and Ms. Capasso are with the Columbia University-New York State Psychiatric Institute; Drs. Emslie and Kennard, and Ms. Mayes are with the University of Texas Southwestern Medical Center in Dallas; Drs. Wells, Compton, Curry, and March are with the Duke University Medical Center; Dr. Coffey is with the New York University Child Study Center; Drs. Walkup, Cwik, Barnett, and Riddle are with Johns Hopkins University.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Stanley', 'Affiliation': 'Drs. Vitiello and Wagner are with the National Institute of Mental Health; Drs. Brent, Bukstein, and Goldstein, and Ms. Zelazny are with the University of Pittsburgh Western Psychiatnc Institute and Clinic; Drs. Greenhill Stanley, Posner, Shen, and Turner, and Ms. Gugga and Ms. Capasso are with the Columbia University-New York State Psychiatric Institute; Drs. Emslie and Kennard, and Ms. Mayes are with the University of Texas Southwestern Medical Center in Dallas; Drs. Wells, Compton, Curry, and March are with the Duke University Medical Center; Dr. Coffey is with the New York University Child Study Center; Drs. Walkup, Cwik, Barnett, and Riddle are with Johns Hopkins University.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Bukstein', 'Affiliation': 'Drs. Vitiello and Wagner are with the National Institute of Mental Health; Drs. Brent, Bukstein, and Goldstein, and Ms. Zelazny are with the University of Pittsburgh Western Psychiatnc Institute and Clinic; Drs. Greenhill Stanley, Posner, Shen, and Turner, and Ms. Gugga and Ms. Capasso are with the Columbia University-New York State Psychiatric Institute; Drs. Emslie and Kennard, and Ms. Mayes are with the University of Texas Southwestern Medical Center in Dallas; Drs. Wells, Compton, Curry, and March are with the Duke University Medical Center; Dr. Coffey is with the New York University Child Study Center; Drs. Walkup, Cwik, Barnett, and Riddle are with Johns Hopkins University.'}, {'ForeName': 'Betsy D', 'Initials': 'BD', 'LastName': 'Kennard', 'Affiliation': 'Drs. Vitiello and Wagner are with the National Institute of Mental Health; Drs. Brent, Bukstein, and Goldstein, and Ms. Zelazny are with the University of Pittsburgh Western Psychiatnc Institute and Clinic; Drs. Greenhill Stanley, Posner, Shen, and Turner, and Ms. Gugga and Ms. Capasso are with the Columbia University-New York State Psychiatric Institute; Drs. Emslie and Kennard, and Ms. Mayes are with the University of Texas Southwestern Medical Center in Dallas; Drs. Wells, Compton, Curry, and March are with the Duke University Medical Center; Dr. Coffey is with the New York University Child Study Center; Drs. Walkup, Cwik, Barnett, and Riddle are with Johns Hopkins University.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Compton', 'Affiliation': 'Drs. Vitiello and Wagner are with the National Institute of Mental Health; Drs. Brent, Bukstein, and Goldstein, and Ms. Zelazny are with the University of Pittsburgh Western Psychiatnc Institute and Clinic; Drs. Greenhill Stanley, Posner, Shen, and Turner, and Ms. Gugga and Ms. Capasso are with the Columbia University-New York State Psychiatric Institute; Drs. Emslie and Kennard, and Ms. Mayes are with the University of Texas Southwestern Medical Center in Dallas; Drs. Wells, Compton, Curry, and March are with the Duke University Medical Center; Dr. Coffey is with the New York University Child Study Center; Drs. Walkup, Cwik, Barnett, and Riddle are with Johns Hopkins University.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Coffey', 'Affiliation': 'Drs. Vitiello and Wagner are with the National Institute of Mental Health; Drs. Brent, Bukstein, and Goldstein, and Ms. Zelazny are with the University of Pittsburgh Western Psychiatnc Institute and Clinic; Drs. Greenhill Stanley, Posner, Shen, and Turner, and Ms. Gugga and Ms. Capasso are with the Columbia University-New York State Psychiatric Institute; Drs. Emslie and Kennard, and Ms. Mayes are with the University of Texas Southwestern Medical Center in Dallas; Drs. Wells, Compton, Curry, and March are with the Duke University Medical Center; Dr. Coffey is with the New York University Child Study Center; Drs. Walkup, Cwik, Barnett, and Riddle are with Johns Hopkins University.'}, {'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Cwik', 'Affiliation': 'Drs. Vitiello and Wagner are with the National Institute of Mental Health; Drs. Brent, Bukstein, and Goldstein, and Ms. Zelazny are with the University of Pittsburgh Western Psychiatnc Institute and Clinic; Drs. Greenhill Stanley, Posner, Shen, and Turner, and Ms. Gugga and Ms. Capasso are with the Columbia University-New York State Psychiatric Institute; Drs. Emslie and Kennard, and Ms. Mayes are with the University of Texas Southwestern Medical Center in Dallas; Drs. Wells, Compton, Curry, and March are with the Duke University Medical Center; Dr. Coffey is with the New York University Child Study Center; Drs. Walkup, Cwik, Barnett, and Riddle are with Johns Hopkins University.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Posner', 'Affiliation': 'Drs. Vitiello and Wagner are with the National Institute of Mental Health; Drs. Brent, Bukstein, and Goldstein, and Ms. Zelazny are with the University of Pittsburgh Western Psychiatnc Institute and Clinic; Drs. Greenhill Stanley, Posner, Shen, and Turner, and Ms. Gugga and Ms. Capasso are with the Columbia University-New York State Psychiatric Institute; Drs. Emslie and Kennard, and Ms. Mayes are with the University of Texas Southwestern Medical Center in Dallas; Drs. Wells, Compton, Curry, and March are with the Duke University Medical Center; Dr. Coffey is with the New York University Child Study Center; Drs. Walkup, Cwik, Barnett, and Riddle are with Johns Hopkins University.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Wagner', 'Affiliation': 'Drs. Vitiello and Wagner are with the National Institute of Mental Health; Drs. Brent, Bukstein, and Goldstein, and Ms. Zelazny are with the University of Pittsburgh Western Psychiatnc Institute and Clinic; Drs. Greenhill Stanley, Posner, Shen, and Turner, and Ms. Gugga and Ms. Capasso are with the Columbia University-New York State Psychiatric Institute; Drs. Emslie and Kennard, and Ms. Mayes are with the University of Texas Southwestern Medical Center in Dallas; Drs. Wells, Compton, Curry, and March are with the Duke University Medical Center; Dr. Coffey is with the New York University Child Study Center; Drs. Walkup, Cwik, Barnett, and Riddle are with Johns Hopkins University.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'March', 'Affiliation': 'Drs. Vitiello and Wagner are with the National Institute of Mental Health; Drs. Brent, Bukstein, and Goldstein, and Ms. Zelazny are with the University of Pittsburgh Western Psychiatnc Institute and Clinic; Drs. Greenhill Stanley, Posner, Shen, and Turner, and Ms. Gugga and Ms. Capasso are with the Columbia University-New York State Psychiatric Institute; Drs. Emslie and Kennard, and Ms. Mayes are with the University of Texas Southwestern Medical Center in Dallas; Drs. Wells, Compton, Curry, and March are with the Duke University Medical Center; Dr. Coffey is with the New York University Child Study Center; Drs. Walkup, Cwik, Barnett, and Riddle are with Johns Hopkins University.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Riddle', 'Affiliation': 'Drs. Vitiello and Wagner are with the National Institute of Mental Health; Drs. Brent, Bukstein, and Goldstein, and Ms. Zelazny are with the University of Pittsburgh Western Psychiatnc Institute and Clinic; Drs. Greenhill Stanley, Posner, Shen, and Turner, and Ms. Gugga and Ms. Capasso are with the Columbia University-New York State Psychiatric Institute; Drs. Emslie and Kennard, and Ms. Mayes are with the University of Texas Southwestern Medical Center in Dallas; Drs. Wells, Compton, Curry, and March are with the Duke University Medical Center; Dr. Coffey is with the New York University Child Study Center; Drs. Walkup, Cwik, Barnett, and Riddle are with Johns Hopkins University.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Goldstein', 'Affiliation': 'Drs. Vitiello and Wagner are with the National Institute of Mental Health; Drs. Brent, Bukstein, and Goldstein, and Ms. Zelazny are with the University of Pittsburgh Western Psychiatnc Institute and Clinic; Drs. Greenhill Stanley, Posner, Shen, and Turner, and Ms. Gugga and Ms. Capasso are with the Columbia University-New York State Psychiatric Institute; Drs. Emslie and Kennard, and Ms. Mayes are with the University of Texas Southwestern Medical Center in Dallas; Drs. Wells, Compton, Curry, and March are with the Duke University Medical Center; Dr. Coffey is with the New York University Child Study Center; Drs. Walkup, Cwik, Barnett, and Riddle are with Johns Hopkins University.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Curry', 'Affiliation': 'Drs. Vitiello and Wagner are with the National Institute of Mental Health; Drs. Brent, Bukstein, and Goldstein, and Ms. Zelazny are with the University of Pittsburgh Western Psychiatnc Institute and Clinic; Drs. Greenhill Stanley, Posner, Shen, and Turner, and Ms. Gugga and Ms. Capasso are with the Columbia University-New York State Psychiatric Institute; Drs. Emslie and Kennard, and Ms. Mayes are with the University of Texas Southwestern Medical Center in Dallas; Drs. Wells, Compton, Curry, and March are with the Duke University Medical Center; Dr. Coffey is with the New York University Child Study Center; Drs. Walkup, Cwik, Barnett, and Riddle are with Johns Hopkins University.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Capasso', 'Affiliation': 'Drs. Vitiello and Wagner are with the National Institute of Mental Health; Drs. Brent, Bukstein, and Goldstein, and Ms. Zelazny are with the University of Pittsburgh Western Psychiatnc Institute and Clinic; Drs. Greenhill Stanley, Posner, Shen, and Turner, and Ms. Gugga and Ms. Capasso are with the Columbia University-New York State Psychiatric Institute; Drs. Emslie and Kennard, and Ms. Mayes are with the University of Texas Southwestern Medical Center in Dallas; Drs. Wells, Compton, Curry, and March are with the Duke University Medical Center; Dr. Coffey is with the New York University Child Study Center; Drs. Walkup, Cwik, Barnett, and Riddle are with Johns Hopkins University.'}, {'ForeName': 'Taryn', 'Initials': 'T', 'LastName': 'Mayes', 'Affiliation': 'Drs. Vitiello and Wagner are with the National Institute of Mental Health; Drs. Brent, Bukstein, and Goldstein, and Ms. Zelazny are with the University of Pittsburgh Western Psychiatnc Institute and Clinic; Drs. Greenhill Stanley, Posner, Shen, and Turner, and Ms. Gugga and Ms. Capasso are with the Columbia University-New York State Psychiatric Institute; Drs. Emslie and Kennard, and Ms. Mayes are with the University of Texas Southwestern Medical Center in Dallas; Drs. Wells, Compton, Curry, and March are with the Duke University Medical Center; Dr. Coffey is with the New York University Child Study Center; Drs. Walkup, Cwik, Barnett, and Riddle are with Johns Hopkins University.'}, {'ForeName': 'Sa', 'Initials': 'S', 'LastName': 'Shen', 'Affiliation': 'Drs. Vitiello and Wagner are with the National Institute of Mental Health; Drs. Brent, Bukstein, and Goldstein, and Ms. Zelazny are with the University of Pittsburgh Western Psychiatnc Institute and Clinic; Drs. Greenhill Stanley, Posner, Shen, and Turner, and Ms. Gugga and Ms. Capasso are with the Columbia University-New York State Psychiatric Institute; Drs. Emslie and Kennard, and Ms. Mayes are with the University of Texas Southwestern Medical Center in Dallas; Drs. Wells, Compton, Curry, and March are with the Duke University Medical Center; Dr. Coffey is with the New York University Child Study Center; Drs. Walkup, Cwik, Barnett, and Riddle are with Johns Hopkins University.'}, {'ForeName': 'S Sonia', 'Initials': 'SS', 'LastName': 'Gugga', 'Affiliation': 'Drs. Vitiello and Wagner are with the National Institute of Mental Health; Drs. Brent, Bukstein, and Goldstein, and Ms. Zelazny are with the University of Pittsburgh Western Psychiatnc Institute and Clinic; Drs. Greenhill Stanley, Posner, Shen, and Turner, and Ms. Gugga and Ms. Capasso are with the Columbia University-New York State Psychiatric Institute; Drs. Emslie and Kennard, and Ms. Mayes are with the University of Texas Southwestern Medical Center in Dallas; Drs. Wells, Compton, Curry, and March are with the Duke University Medical Center; Dr. Coffey is with the New York University Child Study Center; Drs. Walkup, Cwik, Barnett, and Riddle are with Johns Hopkins University.'}, {'ForeName': 'J Blake', 'Initials': 'JB', 'LastName': 'Turner', 'Affiliation': 'Drs. Vitiello and Wagner are with the National Institute of Mental Health; Drs. Brent, Bukstein, and Goldstein, and Ms. Zelazny are with the University of Pittsburgh Western Psychiatnc Institute and Clinic; Drs. Greenhill Stanley, Posner, Shen, and Turner, and Ms. Gugga and Ms. Capasso are with the Columbia University-New York State Psychiatric Institute; Drs. Emslie and Kennard, and Ms. Mayes are with the University of Texas Southwestern Medical Center in Dallas; Drs. Wells, Compton, Curry, and March are with the Duke University Medical Center; Dr. Coffey is with the New York University Child Study Center; Drs. Walkup, Cwik, Barnett, and Riddle are with Johns Hopkins University.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Barnett', 'Affiliation': 'Drs. Vitiello and Wagner are with the National Institute of Mental Health; Drs. Brent, Bukstein, and Goldstein, and Ms. Zelazny are with the University of Pittsburgh Western Psychiatnc Institute and Clinic; Drs. Greenhill Stanley, Posner, Shen, and Turner, and Ms. Gugga and Ms. Capasso are with the Columbia University-New York State Psychiatric Institute; Drs. Emslie and Kennard, and Ms. Mayes are with the University of Texas Southwestern Medical Center in Dallas; Drs. Wells, Compton, Curry, and March are with the Duke University Medical Center; Dr. Coffey is with the New York University Child Study Center; Drs. Walkup, Cwik, Barnett, and Riddle are with Johns Hopkins University.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Zelazny', 'Affiliation': 'Drs. Vitiello and Wagner are with the National Institute of Mental Health; Drs. Brent, Bukstein, and Goldstein, and Ms. Zelazny are with the University of Pittsburgh Western Psychiatnc Institute and Clinic; Drs. Greenhill Stanley, Posner, Shen, and Turner, and Ms. Gugga and Ms. Capasso are with the Columbia University-New York State Psychiatric Institute; Drs. Emslie and Kennard, and Ms. Mayes are with the University of Texas Southwestern Medical Center in Dallas; Drs. Wells, Compton, Curry, and March are with the Duke University Medical Center; Dr. Coffey is with the New York University Child Study Center; Drs. Walkup, Cwik, Barnett, and Riddle are with Johns Hopkins University.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1097/CHI.0b013e3181b5db66']
1755,19602758,Comparison of efficacy of oral drotaverine plus mefenamic acid with paracervical block and with intravenous sedation for pain relief during hysteroscopy and endometrial biopsy.,"BACKGROUND


Office hysteroscopy with endometrial biopsy is usually the first investigation for abnormal uterine bleeding and other uterine diseases.
AIMS


To evaluate the effect of oral drotaverine with mefenamic acid on pain perception during hysteroscopy and endometrial biopsy and to compare it with that of paracervical block using 1% lignocaine and with that of intravenous sedation using diazepam with pentazocine.
SETTINGS AND DESIGN


Outpatient gynecological department and open randomized trial.
MATERIALS AND METHODS


One hundred twenty women undergoing hysteroscopy and endometrial biopsy were randomized into 3 groups. Group I received tablet containing drotaverine hydrochloride (80 mg)+mefenamic acid (250 mg), group II received lignocaine paracervically and group III received intravenous diazepam. The intensity of pain during the procedure, 30 and 60 minutes later on visual analog scale (VAS) was assessed.
STATISTICAL ANALYSIS


Statistical analysis was performed using Kruskal-Wallis test, with the Bonferroni correction, the t test, and the chi2 test.
RESULTS


Groups were similar in age, parity, vaginal birth or relevant medical history. A statistically significant difference in pain scores was noted among the 3 groups during the procedure (group I, 4.13+/-1.28; group II, 5.93+/-1.26; group III, 5.58+/-1.51), (P<0.001); as well as 30 minutes later (group I, 1.78+/-0.89; group II, 2.53+/-0.81; group III, 2.23+/-0.94), (P<0.001) and 60 minutes later (group I, 1.2+/-0.46; group II, 1.98+/-0.83; group III, 1.68+/-0.75), (P<0.001). VAS at different time intervals among the groups was also statistically significant. No adverse effects were observed.
CONCLUSIONS


Oral drotaverine with mefenamic acid is effective in women undergoing hysteroscopy and endometrial biopsy.",2009,A statistically significant difference in pain scores was noted among the 3 groups during the procedure (,"['One hundred twenty women undergoing hysteroscopy and endometrial biopsy', 'women undergoing hysteroscopy and endometrial biopsy', 'during hysteroscopy and endometrial biopsy']","['oral drotaverine plus mefenamic acid with paracervical block and with intravenous sedation', 'lignocaine', 'mefenamic acid', 'drotaverine with mefenamic acid', 'diazepam with pentazocine', 'tablet containing drotaverine hydrochloride (80 mg)+mefenamic acid', 'lignocaine paracervically and group III received intravenous diazepam']","['pain perception', 'VAS', 'visual analog scale (VAS', 'pain scores', 'intensity of pain', 'adverse effects', 'pain relief']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0585591', 'cui_str': 'Hysteroscopy and endometrial biopsy (procedure)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0058762', 'cui_str': 'drotaverine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0025152', 'cui_str': 'Mefenamic Acid'}, {'cui': 'C0030401', 'cui_str': 'Paracervical Block'}, {'cui': 'C0412775', 'cui_str': 'Intravenous sedation (procedure)'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0030873', 'cui_str': 'Pentazocine'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",120.0,0.0473571,A statistically significant difference in pain scores was noted among the 3 groups during the procedure (,"[{'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India. jbsharma2000@gmail.com'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Aruna', 'Affiliation': ''}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'Kallol Kumar', 'Initials': 'KK', 'LastName': 'Roy', 'Affiliation': ''}, {'ForeName': 'Neena', 'Initials': 'N', 'LastName': 'Malhotra', 'Affiliation': ''}, {'ForeName': 'Sunesh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': ''}]",Indian journal of medical sciences,['10.4103/0019-5359.53394']
1756,31511330,Lymphocyte counts and infection rates: Long-term fingolimod treatment in primary progressive MS.,"OBJECTIVE


To evaluate lymphocyte counts and incidences of infections in patients with primary progressive MS (PPMS) receiving fingolimod 0.5 mg/d or placebo over 5 years during the INFORMS study, to assess infection rates with longer-term treatment.
METHODS


INFORMS was a randomized, multicenter, double-blind, placebo-controlled, parallel-group, phase 3 study of the sphingosine 1-phosphate receptor modulator fingolimod in patients with PPMS. Lymphocyte counts and incidences of infections were compared in patients receiving fingolimod or placebo. Infection rates were assessed in patients receiving fingolimod according to nadir and mean absolute lymphocyte count (ALC).
RESULTS


Overall, 336 patients received fingolimod 0.5 mg/d (total exposure: 908.1 patient-years), and 487 received placebo (1,423.5 patient-years). In patients receiving fingolimod, mean ALC decreased by approximately 70% in the 2 weeks following treatment initiation and remained stable throughout the study. The incidences of all infections in the fingolimod and placebo groups were similar (53.6 vs 51.9 per 100 patient-years). The most common infections in patients receiving fingolimod were urinary tract infections (5.7 per 100 patient-years), upper respiratory tract infections (4.2 per 100 patient-years), and influenza (3.2 per 100 patient-years); incidences were similar in the placebo group (5.9, 4.2, and 3.1 per 100 patient-years, respectively). There was no apparent association between nadir or mean ALC and incidence of infection-related adverse events.
CONCLUSIONS


In patients with PPMS, long-term treatment with fingolimod 0.5 mg/d for up to 5 years led to an expected decrease of approximately 70% in mean ALC and did not appear to correlate with increased risk of infection.
CLASSIFICATION OF EVIDENCE


Because this is a secondary analysis, this study provides Class II evidence that long-term PPMS treatment with fingolimod decreased mean ALC by approximately 70%, but did not significantly increase infection risk.",2019,"The most common infections in patients receiving fingolimod were urinary tract infections (5.7 per 100 patient-years), upper respiratory tract infections (4.2 per 100 patient-years), and influenza (3.2 per 100 patient-years); incidences were similar in the placebo group (5.9, 4.2, and 3.1 per 100 patient-years, respectively).","['336 patients received', 'patients with primary progressive MS (PPMS) receiving fingolimod 0.5 mg/d or', 'primary progressive MS', 'patients with PPMS']","['placebo', 'fingolimod', 'sphingosine 1-phosphate receptor modulator fingolimod']","['Lymphocyte counts and incidences of infections', 'incidences of all infections', 'infection rates', 'Lymphocyte counts and infection rates', 'urinary tract infections', 'infection risk', 'mean ALC', 'Infection rates', 'upper respiratory tract infections', 'nadir or mean ALC and incidence of infection-related adverse events', 'risk of infection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C2938759', 'cui_str': 'fingolimod 0.5 MG'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0390526', 'cui_str': 'Sphingosine-1-Phosphate Receptors'}]","[{'cui': 'C0200635', 'cui_str': 'Lymphocyte Number'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",336.0,0.0953721,"The most common infections in patients receiving fingolimod were urinary tract infections (5.7 per 100 patient-years), upper respiratory tract infections (4.2 per 100 patient-years), and influenza (3.2 per 100 patient-years); incidences were similar in the placebo group (5.9, 4.2, and 3.1 per 100 patient-years, respectively).","[{'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Fox', 'Affiliation': 'From the Central Texas Neurology Consultants (E.J.F.), Round Rock, TX; Icahn School of Medicine at Mount Sinai (F.D.L.), New York, NY; McGovern Medical School (J.S.W.), The University of Texas Health Science Center at Houston (UTHealth), TX; Mellen Center for Multiple Sclerosis Treatment and Research (J.A.C.), Neurological Institute, Cleveland Clinic Foundation, OH; Oxford PharmaGenesis Ltd (I.M.W.), UK; Novartis Pharmaceuticals Corporation (X.M., M.Z., S.K.), East Hanover, NJ; and The University of California, San Francisco (UCSF); Weill Institute for Neurosciences, Department of Neurology (B.A.C.C.), San Francisco, CA. foxtexms@gmail.com.'}, {'ForeName': 'Fred D', 'Initials': 'FD', 'LastName': 'Lublin', 'Affiliation': 'From the Central Texas Neurology Consultants (E.J.F.), Round Rock, TX; Icahn School of Medicine at Mount Sinai (F.D.L.), New York, NY; McGovern Medical School (J.S.W.), The University of Texas Health Science Center at Houston (UTHealth), TX; Mellen Center for Multiple Sclerosis Treatment and Research (J.A.C.), Neurological Institute, Cleveland Clinic Foundation, OH; Oxford PharmaGenesis Ltd (I.M.W.), UK; Novartis Pharmaceuticals Corporation (X.M., M.Z., S.K.), East Hanover, NJ; and The University of California, San Francisco (UCSF); Weill Institute for Neurosciences, Department of Neurology (B.A.C.C.), San Francisco, CA.'}, {'ForeName': 'Jerry S', 'Initials': 'JS', 'LastName': 'Wolinsky', 'Affiliation': 'From the Central Texas Neurology Consultants (E.J.F.), Round Rock, TX; Icahn School of Medicine at Mount Sinai (F.D.L.), New York, NY; McGovern Medical School (J.S.W.), The University of Texas Health Science Center at Houston (UTHealth), TX; Mellen Center for Multiple Sclerosis Treatment and Research (J.A.C.), Neurological Institute, Cleveland Clinic Foundation, OH; Oxford PharmaGenesis Ltd (I.M.W.), UK; Novartis Pharmaceuticals Corporation (X.M., M.Z., S.K.), East Hanover, NJ; and The University of California, San Francisco (UCSF); Weill Institute for Neurosciences, Department of Neurology (B.A.C.C.), San Francisco, CA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Cohen', 'Affiliation': 'From the Central Texas Neurology Consultants (E.J.F.), Round Rock, TX; Icahn School of Medicine at Mount Sinai (F.D.L.), New York, NY; McGovern Medical School (J.S.W.), The University of Texas Health Science Center at Houston (UTHealth), TX; Mellen Center for Multiple Sclerosis Treatment and Research (J.A.C.), Neurological Institute, Cleveland Clinic Foundation, OH; Oxford PharmaGenesis Ltd (I.M.W.), UK; Novartis Pharmaceuticals Corporation (X.M., M.Z., S.K.), East Hanover, NJ; and The University of California, San Francisco (UCSF); Weill Institute for Neurosciences, Department of Neurology (B.A.C.C.), San Francisco, CA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Williams', 'Affiliation': 'From the Central Texas Neurology Consultants (E.J.F.), Round Rock, TX; Icahn School of Medicine at Mount Sinai (F.D.L.), New York, NY; McGovern Medical School (J.S.W.), The University of Texas Health Science Center at Houston (UTHealth), TX; Mellen Center for Multiple Sclerosis Treatment and Research (J.A.C.), Neurological Institute, Cleveland Clinic Foundation, OH; Oxford PharmaGenesis Ltd (I.M.W.), UK; Novartis Pharmaceuticals Corporation (X.M., M.Z., S.K.), East Hanover, NJ; and The University of California, San Francisco (UCSF); Weill Institute for Neurosciences, Department of Neurology (B.A.C.C.), San Francisco, CA.'}, {'ForeName': 'Xiangyi', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'From the Central Texas Neurology Consultants (E.J.F.), Round Rock, TX; Icahn School of Medicine at Mount Sinai (F.D.L.), New York, NY; McGovern Medical School (J.S.W.), The University of Texas Health Science Center at Houston (UTHealth), TX; Mellen Center for Multiple Sclerosis Treatment and Research (J.A.C.), Neurological Institute, Cleveland Clinic Foundation, OH; Oxford PharmaGenesis Ltd (I.M.W.), UK; Novartis Pharmaceuticals Corporation (X.M., M.Z., S.K.), East Hanover, NJ; and The University of California, San Francisco (UCSF); Weill Institute for Neurosciences, Department of Neurology (B.A.C.C.), San Francisco, CA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Ziehn', 'Affiliation': 'From the Central Texas Neurology Consultants (E.J.F.), Round Rock, TX; Icahn School of Medicine at Mount Sinai (F.D.L.), New York, NY; McGovern Medical School (J.S.W.), The University of Texas Health Science Center at Houston (UTHealth), TX; Mellen Center for Multiple Sclerosis Treatment and Research (J.A.C.), Neurological Institute, Cleveland Clinic Foundation, OH; Oxford PharmaGenesis Ltd (I.M.W.), UK; Novartis Pharmaceuticals Corporation (X.M., M.Z., S.K.), East Hanover, NJ; and The University of California, San Francisco (UCSF); Weill Institute for Neurosciences, Department of Neurology (B.A.C.C.), San Francisco, CA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Kolodny', 'Affiliation': 'From the Central Texas Neurology Consultants (E.J.F.), Round Rock, TX; Icahn School of Medicine at Mount Sinai (F.D.L.), New York, NY; McGovern Medical School (J.S.W.), The University of Texas Health Science Center at Houston (UTHealth), TX; Mellen Center for Multiple Sclerosis Treatment and Research (J.A.C.), Neurological Institute, Cleveland Clinic Foundation, OH; Oxford PharmaGenesis Ltd (I.M.W.), UK; Novartis Pharmaceuticals Corporation (X.M., M.Z., S.K.), East Hanover, NJ; and The University of California, San Francisco (UCSF); Weill Institute for Neurosciences, Department of Neurology (B.A.C.C.), San Francisco, CA.'}, {'ForeName': 'Bruce A C', 'Initials': 'BAC', 'LastName': 'Cree', 'Affiliation': 'From the Central Texas Neurology Consultants (E.J.F.), Round Rock, TX; Icahn School of Medicine at Mount Sinai (F.D.L.), New York, NY; McGovern Medical School (J.S.W.), The University of Texas Health Science Center at Houston (UTHealth), TX; Mellen Center for Multiple Sclerosis Treatment and Research (J.A.C.), Neurological Institute, Cleveland Clinic Foundation, OH; Oxford PharmaGenesis Ltd (I.M.W.), UK; Novartis Pharmaceuticals Corporation (X.M., M.Z., S.K.), East Hanover, NJ; and The University of California, San Francisco (UCSF); Weill Institute for Neurosciences, Department of Neurology (B.A.C.C.), San Francisco, CA.'}]",Neurology(R) neuroimmunology & neuroinflammation,['10.1212/NXI.0000000000000614']
1757,32118601,CORR Insights®: No Difference in 5-year Clinical or Radiographic Outcomes Between Kinematic and Mechanical Alignment in TKA: A Randomized Controlled Trial.,,2020,,['TKA'],['CORR Insights®'],[],[],[],[],,0.18893,,"[{'ForeName': 'Petra J C', 'Initials': 'PJC', 'LastName': 'Heesterbeek', 'Affiliation': 'P. J. C. Heesterbeek PhD, Senior Researcher, Sint Maartenskliniek, Department of Research, Nijmegen, Netherlands.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001202']
1758,29496299,[Efficacy of a multidisciplinary care management program for patients admitted at hospital because of heart failure (ProMIC)].,"OBJECTIVE


To assess the efficacy of the ProMIC, multidisciplinary program for patients admitted at hospital because of heart failure (HF) programme, in reducing the HF-related readmission rate.
DESING


Quasi-experimental research with control group.
SETTINGS


Twelve primary health care centres and 3 hospitals from the Basque Country.
PARTICIPANTS


Aged 40 years old or above patients admitted for HF with a New York Heart Association functional class II to IV.
INTERVENTIONS


Patients in the intervention group carried out the ProMIC programme, a structured clinical intervention based on clinical guidelines and on the chronic care model. Control group received usual care.
MAIN MEASUREMENTS


The rate of readmission for HF and health-related quality of life RESULTS: One hundred fifty five patients were included in ProMIC group and 129 in control group. 45 rehospitalisation due to heart failure happened in ProMIC versus 75 in control group (adjusted hazard ratio=0.59, CI 95%: 0.36-0.98; P=.049). There were significant differences in specific quality of life al 6 months. No significant differences were found in rehospitalisation due to all causes, due to cardiovascular causes, visits to emergency room, mortality, the combined variable of these events, the functional capacity or quality of life at 12 months of follow up.
CONCLUSIONS


ProMIC reduces significantly heart failure rehospitalisation and improve quality of life al 6 months of follow up. No significant differences were found in the rests of variables.",2019,"No significant differences were found in rehospitalisation due to all causes, due to cardiovascular causes, visits to emergency room, mortality, the combined variable of these events, the functional capacity or quality of life at 12 months of follow up.
","['Twelve primary health care centres and 3 hospitals from the Basque Country', 'patients admitted at hospital because of heart failure (HF) programme', 'Aged 40 years old or above patients admitted for HF with a New York Heart Association functional class II to IV', 'One hundred fifty five patients were included in ProMIC group and 129 in control group', 'patients admitted at hospital because of heart failure (ProMIC']","['multidisciplinary care management program', 'ProMIC programme, a structured clinical intervention based on clinical guidelines and on the chronic care model', 'usual care']","['cardiovascular causes, visits to emergency room, mortality, the combined variable of these events, the functional capacity or quality of life', 'specific quality of life', 'heart failure rehospitalisation and improve quality of life', 'rate of readmission for HF and health-related quality of life', 'heart failure happened in ProMIC']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0337796', 'cui_str': 'Basques (ethnic group)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0034380'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",155.0,0.0283836,"No significant differences were found in rehospitalisation due to all causes, due to cardiovascular causes, visits to emergency room, mortality, the combined variable of these events, the functional capacity or quality of life at 12 months of follow up.
","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Domingo', 'Affiliation': 'Medicina Familiar y Comunitaria, Gerencia de Atención Primaria del Servicio Cántabro de Salud, Santander, España. Electronic address: Cristina.domingo@scsalud.es.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Aros', 'Affiliation': 'Hospital Universitario de Araba, Osakidetza, Araba, España; Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y de la Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, España.'}, {'ForeName': 'Agurtzane', 'Initials': 'A', 'LastName': 'Otxandategi', 'Affiliation': 'Equipo de atención primaria, Centro de Salud Galdakao, Galdakao, Bizkaia, España; OSI Barrualde, Osakidetza, Galdakao, Bizkaia, España.'}, {'ForeName': 'Idoia', 'Initials': 'I', 'LastName': 'Beistegui', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario de Araba, Sede Santiago, Osakidetza, Araba, España.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Besga', 'Affiliation': 'Universidad del País Vasco, Vitoria-Gasteiz, España.'}, {'ForeName': 'Pedro María', 'Initials': 'PM', 'LastName': 'Latorre', 'Affiliation': 'Medicina Familiar y Comunitaria, Unidad de investigación de Atención Primaria de Bizkaia, Osakidetza, Bilbao, Bizkaia, España; BioCruces Health Resarch Institute, Barakaldo, España.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Atencion primaria,['10.1016/j.aprim.2017.09.011']
1759,16351593,Antihypertensive treatment in patients with end-stage renal disease.,"Arterial hypertension is a common finding in patients with end stage renal disease (80% patients are hypertensive). Cardiovascular diseases are the main cause of death in haemodialysis. The present study was performed to asses' successful treatment in hypertensive chronic haemodialysis patients by ultra filtration only and ultra filtration combined with medics. We studied 80 hypertensive adult patients who had been on regular haemodialysis treatment for at least 12 months (average duration of 41 months). All subjects were divided in two different antihypertensive treatment groups including 40 subjects each. The first group of patients were treated with trandolapril and ultra filtration, and the second group of patients were only treated with ultra filtration (control group). Blood pressure measurements before and after HD sessions were performed for each patient. Blood pressure control was defined using World Health Organization criteria 140/90 mm Hg. Average systolic blood pressure levels, after haemodialysis, were in the first group of patients 146.33 +/- 9.7 mm Hg, and in the control group 157,86 +/- 10.33 mm Hg. Average diastolic blood pressure was 87.83 +/- 8.11 mm Hg in the first group of patients and, in the control group it was 91.03 +/- 10.67 mm Hg. There were significant differences between systolic blood pressure level in the first group of patients and the control group of patients as well as in diastolic blood pressure (p < 0.05). We conclude that an antihypertensive therapy by trandolapril is more effective than ultra filtration alone in hypertensive patients on chronic haemodialysis.",2005,There were significant differences between systolic blood pressure level in the first group of patients and the control group of patients as well as in diastolic blood pressure (p < 0.05).,"['hypertensive chronic haemodialysis patients by ultra filtration only and ultra filtration combined with medics', 'patients with end-stage renal disease', 'patients with end stage renal disease (80% patients are hypertensive', '80 hypertensive adult patients who had been on regular haemodialysis treatment for at least 12 months (average duration of 41 months', 'hypertensive patients on chronic haemodialysis', 'All subjects were divided in two different antihypertensive treatment groups including 40 subjects each']","['trandolapril', 'Antihypertensive treatment', 'trandolapril and ultra filtration', 'ultra filtration (control group']","['Arterial hypertension', 'Blood pressure control', 'Average diastolic blood pressure', 'diastolic blood pressure', 'Average systolic blood pressure levels', 'Blood pressure measurements', 'systolic blood pressure level']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C1740835', 'cui_str': 'Chronic haemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016107', 'cui_str': 'Filtration - action'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0076891', 'cui_str': 'trandolapril'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0016107', 'cui_str': 'Filtration - action'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1282163', 'cui_str': 'Average diastolic blood pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C1282151', 'cui_str': 'Average systolic blood pressure'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking (procedure)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",80.0,0.0122663,There were significant differences between systolic blood pressure level in the first group of patients and the control group of patients as well as in diastolic blood pressure (p < 0.05).,"[{'ForeName': 'Mensura', 'Initials': 'M', 'LastName': 'Ascerić', 'Affiliation': 'Department of Pharmacology and Toxicology, University of Tuzla, Medical Faculty, Bosnia and Herzegovina.'}, {'ForeName': 'Nedzad', 'Initials': 'N', 'LastName': 'Mulabegović', 'Affiliation': ''}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Nuhbegović', 'Affiliation': ''}, {'ForeName': 'Alma', 'Initials': 'A', 'LastName': 'Nadarević', 'Affiliation': ''}, {'ForeName': 'Muamera', 'Initials': 'M', 'LastName': 'Mujcinagić-Vrabac', 'Affiliation': ''}]",Bosnian journal of basic medical sciences,[]
1760,31516558,Comparative outcomes of foot cast and short leg cast in pseudo-Jones avulsion fracture: a single blinded randomized controlled trial.,"Background


Fractures of the metatarsal bones account for 35% of all foot fractures. Conservative management of fractures proximal to the metaphyseal-diaphyseal junction of the fifth metatarsal bone (pseudo-Jones) is by protected weight bearing. The methods of protected weight bearing include short-leg casting and splinting (boot cast, Jones's bandage and elastic bandage). However, currently there is no consensus as to which method is the most suitable.
Method


We have conducted a randomized controlled trial to compare outcomes of foot casting (FC) and short leg casting (SLC) to assess pain, function and complication outcomes for the treatment of pseudo-jones metatarsal fractures. This single-center, single blind,randomized controlled trial was conducted between 1 June 2016-1 July 2018 at Police General Hospital, Bangkok, Thailand.
Result


A total of 72 pseudo-jones metatarsal fracture participants were randomly allocated to treatment by foot cast or short leg cast. The primary outcomes were pain VAS, AOFAS and complications measured at 2, 4, 6 and 8 weeks after receiving the treatment. Seventy-two patients (36 paticipants per group) were enrolled to receive either FC or SLC. The mean VAS measured at baseline, 2 weeks, 4 weeks, 6 weeks and 8 weeks were 7.36, 1.97, 0.58, 0.17 and 0.08 respectively in the FC group; and 6.09, 2.91, 1.23, 0.37 and 0.11 respectively in the SLC group. The mean AOFAS at baseline, 2, 4, 6 and 8 weeks were 33.60, 68.22, 82.72, 91.75 and 98.11 respectively in the FC group; and 32.60, 60.20, 70.20, 92.24 and 99.13 in the SLC group. The estimated mean difference of pain VAS and AOFAS at 2 weeks and 4 weeks were - 0.94 (95% CI: - 1.53, - 0.34), - 0.65 (95%CI: - 1.24, - 0.05), 8.02 (95%CI: 3.74, 12.10) and 12.52 (95%CI: 8.27, 16.78), which were statistically significantly better in the FC groups when compared to the SLC groups. However, there were no statistically significant difference between the two groups at 6 and 8 weeks.
Conclusion


This study demonstrated that the application of foot casting can improve pain VAS and AOFAS function at 2 and 4 weeks in the treatment of pseudo-jones metatarsal fractures when compared to short leg casting. However, at 6 and 8 weeks, there were no statistically significantly different between the two groups.",2019,The estimated mean difference of pain VAS and AOFAS at 2 weeks and 4 weeks were - 0.94,"['72 pseudo-jones metatarsal fracture participants', 'pseudo-Jones avulsion fracture', '1 June 2016-1 July 2018 at Police General Hospital, Bangkok, Thailand', 'pseudo-jones metatarsal fractures', 'Seventy-two patients (36 paticipants per group']","[""protected weight bearing include short-leg casting and splinting (boot cast, Jones's bandage and elastic bandage"", 'foot cast or short leg cast', 'foot cast and short leg cast', 'foot casting (FC) and short leg casting (SLC', 'FC or SLC']","['pain VAS and AOFAS function', 'pain VAS, AOFAS and complications', 'pain, function and complication outcomes', 'mean AOFAS', 'mean VAS', 'pain VAS and AOFAS']","[{'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}, {'cui': 'C0025584', 'cui_str': 'Metatarsals'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0332758', 'cui_str': 'Sprain Fracture'}, {'cui': 'C0085098', 'cui_str': 'Police'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0426901', 'cui_str': 'Short leg (finding)'}, {'cui': 'C0204861', 'cui_str': 'Application of splint (procedure)'}, {'cui': 'C0179666', 'cui_str': 'Boot cast'}, {'cui': 'C0150468', 'cui_str': 'Application of bandage (procedure)'}, {'cui': 'C0336591', 'cui_str': 'Elastic bandage'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",72.0,0.0974265,The estimated mean difference of pain VAS and AOFAS at 2 weeks and 4 weeks were - 0.94,"[{'ForeName': 'Peerapong', 'Initials': 'P', 'LastName': 'Piyapittayanun', 'Affiliation': '1Orthopedics Department, Police General Hospital, Bangkok, Thailand.'}, {'ForeName': 'Kanakij', 'Initials': 'K', 'LastName': 'Mutthakalin', 'Affiliation': '1Orthopedics Department, Police General Hospital, Bangkok, Thailand.'}, {'ForeName': 'Alisara', 'Initials': 'A', 'LastName': 'Arirachakaran', 'Affiliation': '2Orthopedics Department, Bumrungrad Hospital, Bangkok, Thailand.'}, {'ForeName': 'Jatupon', 'Initials': 'J', 'LastName': 'Kongtharvonskul', 'Affiliation': '3Sport and orthopedic center, Samitivej hospital and Section for Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi Hospital, Bangkok, Thailand.'}]",Journal of foot and ankle research,['10.1186/s13047-019-0359-5']
1761,17694386,"Comparative efficacy of low dose, daily versus alternate day plasma exchange in severe myasthenia gravis: a randomised trial.","OBJECTIVE


To evaluate the comparative efficacy of low dose daily versus alternate day plasma exchange in patients with severe myasthenia.
METHODS


Thirty three patients with myasthenia gravis (Osserman's stage II b and III) were randomized to receive alternate day (n = 17) or daily low dose plasma exchange (n = 16). Plasma exchange were carried on each patient, number of exchanges varying subject to their requirements and 20-25 ml/kg plasma was removed during each session. Myasthenia gravis disease scale (MGDS) score was evaluated before and after the procedure. Time to wean off ventilator, removal of nasogastric tube and total duration of hospital stay were also assessed.
RESULTS


There was no statistically significant difference between daily vs. alternate day group with regards to change in MGDS score, percentage change in MGDS score, and complication rates. A decreased hospital stay was observed in patients on daily plasma exchange which almost reached statistical significance.
CONCLUSION


We conclude from our study that daily and alternate day plasma exchange are similar in their efficacy and complication rates, however the daily schedule could be a preferred modality due to decreased hospital stay.",2007,"There was no statistically significant difference between daily vs. alternate day group with regards to change in MGDS score, percentage change in MGDS score, and complication rates.","[""Thirty three patients with myasthenia gravis (Osserman's stage II b and III"", 'severe myasthenia gravis', 'patients with severe myasthenia']",['daily low dose plasma exchange'],"['Time to wean off ventilator, removal of nasogastric tube and total duration of hospital stay', 'Myasthenia gravis disease scale (MGDS) score', 'efficacy and complication rates', 'hospital stay', 'MGDS score, percentage change in MGDS score, and complication rates']","[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia Gravis'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0947912'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0032113', 'cui_str': 'Plasma Exchange'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0204823', 'cui_str': 'Nasogastric tube removal (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0947912'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",33.0,0.238637,"There was no statistically significant difference between daily vs. alternate day group with regards to change in MGDS score, percentage change in MGDS score, and complication rates.","[{'ForeName': 'Isha', 'Initials': 'I', 'LastName': 'Trikha', 'Affiliation': 'Department of Neurology, Neurosciences Centre, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Goyal', 'Affiliation': ''}, {'ForeName': 'Garima', 'Initials': 'G', 'LastName': 'Shukla', 'Affiliation': ''}, {'ForeName': 'Rama', 'Initials': 'R', 'LastName': 'Bhasin', 'Affiliation': ''}, {'ForeName': 'Madhuri', 'Initials': 'M', 'LastName': 'Behari', 'Affiliation': ''}]",Journal of neurology,[]
1762,32119937,Prospective randomized trial comparing the pocket-creation method and conventional method of colorectal endoscopic submucosal dissection.,"BACKGROUND AND AIMS


Colorectal endoscopic submucosal dissection (ESD) is recognized as a challenging procedure. Previously, we reported that a new ESD strategy using the pocket-creation method (PCM) is useful for colorectal ESD, but no prospective randomized study has evaluated the efficacy of the PCM. The aim of this study was to evaluate the efficacy and safety of PCM for colorectal ESD compared with the conventional method (CM).
METHODS


This was a prospective randomized controlled trial at 3 institutions in Japan. Patients with superficial colorectal neoplastic lesions >20 mm predicted to be intramucosal were randomly assigned to undergo ESD using the PCM or CM. Primary outcome was the ESD completion rate defined as completion of colorectal ESD with an en bloc resection using the assigned ESD method without changing to other methods or assisted by other devices.
RESULTS


We analyzed 59 patients with 59 colorectal tumors in the PCM group and 55 in the CM group. The ESD completion rate was significantly higher in the PCM group compared with the CM group (93% [55/59] vs 73% [40/55]; P  = .01). En bloc resection rates, R0 resection rates, procedure time, and dissection speed were not significantly different between the 2 groups. The incidence of adverse events was similar in the 2 groups.
CONCLUSIONS


Use of the PCM allows the endoscopist to complete the procedure with the intended method more often than the CM with similar clinical outcomes. (Clinical trial registration number: UMIN 000024394.).",2020,"En bloc resection rates, R0 resection rates, procedure time and dissection speed were not significantly different comparing the 2 groups.","['Patients with superficial colorectal neoplastic lesions >20 mm predicted to be intramucosal', '59 patients with 59 colorectal tumors in the PCM group and 55 in the CM group', '3 institutions in Japan']","['pocket-creation method and conventional method of colorectal endoscopic submucosal dissection', 'conventional method (CM', 'PCM or CM', 'Colorectal endoscopic submucosal dissection (ESD', 'PCM']","['En bloc resection rates, R0 resection rates, procedure time and dissection speed', 'efficacy and safety', 'ESD completion rate defined as completion of colorectal ESD with an en bloc resection using the assigned ESD method without changing to other methods or assisted by other devices', 'adverse events', 'ESD completion rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0009404', 'cui_str': 'Colorectal Tumors'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0441513', 'cui_str': 'Construction (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}]","[{'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",59.0,0.0662173,"En bloc resection rates, R0 resection rates, procedure time and dissection speed were not significantly different comparing the 2 groups.","[{'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yamashina', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan; Gastroenterology and Hepatology, Osaka Red Cross Hospital, Osaka, Japan.'}, {'ForeName': 'Daiki', 'Initials': 'D', 'LastName': 'Nemoto', 'Affiliation': 'Department of Coloproctology, Fukushima Medical University, Aizu Medical Center, Aizuwakamatsu, Japan.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Hayashi', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Fukuda', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': 'Takahito', 'Initials': 'T', 'LastName': 'Takezawa', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Aizawa', 'Affiliation': 'Department of Coloproctology, Fukushima Medical University, Aizu Medical Center, Aizuwakamatsu, Japan.'}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': 'Yoshimasa', 'Initials': 'Y', 'LastName': 'Miura', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': 'Keijiro', 'Initials': 'K', 'LastName': 'Sunada', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': 'Alan Kawarai', 'Initials': 'AK', 'LastName': 'Lefor', 'Affiliation': 'Department of Surgery, Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': 'Kazutomo', 'Initials': 'K', 'LastName': 'Togashi', 'Affiliation': 'Department of Coloproctology, Fukushima Medical University, Aizu Medical Center, Aizuwakamatsu, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.02.034']
1763,31366999,The effectiveness of home versus community-based weight control programmes initiated soon after breast cancer diagnosis: a randomised controlled trial.,"BACKGROUND


Breast cancer diagnosis may be a teachable moment for lifestyle behaviour change and to prevent adjuvant therapy associated weight gain. We assessed the acceptability and effectiveness of two weight control programmes initiated soon after breast cancer diagnosis to reduce weight amongst overweight or obese women and prevent gains in normal-weight women.
METHODS


Overweight or obese (n = 243) and normal weight (n = 166) women were randomised to a three-month unsupervised home (home), a supervised community weight control programme (community) or to standard written advice (control). Primary end points were change in weight and body fat at 12 months. Secondary end points included change in insulin, cardiovascular risk markers, quality of life and cost-effectiveness of the programmes.
RESULTS


Forty-three percent of eligible women were recruited. Both programmes reduced weight and body fat: home vs. control mean (95% CI); weight -2.3 (-3.5, -1.0) kg, body fat -1.6 (-2.6, -0.7) kg, community vs. control; weight -2.4 (-3.6, -1.1) kg, body fat -1.4 (-2.4, -0.5) kg (all p < 0.001). The community group increased physical activity, reduced insulin, cardiovascular disease risk markers, increased QOL and was cost-effective.
CONCLUSIONS


The programmes were equally effective for weight control, but the community programme had additional benefits.
CLINICAL TRIAL REGISTRATION


ISRCTN68576140.",2019,Both programmes reduced weight and body fat: home vs. control,"['overweight or obese women and prevent gains in normal-weight women', 'Forty-three percent of eligible women were recruited', 'Overweight or obese (n\u2009=\u2009243) and normal weight (n\u2009', '166) women', 'breast cancer diagnosis']","['home versus community-based weight control programmes', 'supervised community weight control programme (community) or to standard written advice (control']","['change in weight and body fat', 'acceptability and effectiveness', 'change in insulin, cardiovascular risk markers, quality of life and cost-effectiveness of the programmes', 'physical activity, reduced insulin, cardiovascular disease risk markers, increased QOL and was cost-effective', 'weight and body fat']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen (regime/therapy)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0034380'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",,0.108066,Both programmes reduced weight and body fat: home vs. control,"[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Harvie', 'Affiliation': 'Prevent Breast Cancer Research Unit, The Nightingale Centre, Manchester University NHS Foundation Trust, Manchester, UK. michelle.harvie@manchester.ac.uk.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Pegington', 'Affiliation': 'Prevent Breast Cancer Research Unit, The Nightingale Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'McMullan', 'Affiliation': 'Prevent Breast Cancer Research Unit, The Nightingale Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Bundred', 'Affiliation': 'Manchester Breast Centre, Manchester Cancer Research Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Livingstone', 'Affiliation': 'The Nightingale Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Campbell', 'Affiliation': 'School of Applied Sciences, Edinburgh Napier University, Edinburgh, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Wolstenholme', 'Affiliation': 'Nuffield Department of Population Health, Health Economics Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eleanora', 'Initials': 'E', 'LastName': 'Lovato', 'Affiliation': 'Nuffield Department of Population Health, Health Economics Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Campbell', 'Affiliation': 'National Perinatal Epidemiology Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Adams', 'Affiliation': 'Clinical Radiology, Faculty of Medicine Biology and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Speed', 'Affiliation': 'The School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Morris', 'Affiliation': 'Department of Medical Statistics, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Howell', 'Affiliation': 'Manchester Breast Centre, Manchester Cancer Research Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Howell', 'Affiliation': 'Prevent Breast Cancer Research Unit, The Nightingale Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}]",British journal of cancer,['10.1038/s41416-019-0522-6']
1764,31383985,Survival benefits of dose-dense early postoperative intraperitoneal chemotherapy in front-line therapy for advanced ovarian cancer: a randomised controlled study.,"Dose-dense early postoperative intraperitoneal chemotherapy (DD-EPIC) significantly increased non-progression rate in advanced ovarian cancer (OC) patients. We report final overall survival (OS) results to further strengthen the efficacy of DD-EPIC in the front-line therapy. In this phase 2 trial, 218 patients with FIGO IIIC-IV OC were randomly allocated to receive DD-EPIC followed by intravenous (IV) chemotherapy (DD-EPIC group), or IV chemotherapy alone (IV group). The study was prespecified to detect differences in progression-free survival (PFS) and OS. At a median follow-up period of 69.1 months, the median OS was 67.5 and 46.3 months in the DD-EPIC and IV group, respectively. The probability rate of OS at 5 years was 61.0% with DD-EPIC, and 38.2% with IV (hazard ratio [HR] for death from OC, 0.70; 95% confidence interval [CI], 0.49-1.00). DD-EPIC was associated with a prolonged PFS compared with the IV group (the estimated rate of PFS at 5 years, 26.0% vs. 8.5%; HR for disease progression, 0.64; 95% CI, 0.47-0.86). DD-EPIC was associated with a longer OS than IV chemotherapy alone. It may be considered as a valuable option of the front-line therapy for advanced ovarian cancer.Trial registration: ClinicalTrials.gov, NCT01669226 (date of registration: August 20, 2012).",2019,"DD-EPIC was associated with a prolonged PFS compared with the IV group (the estimated rate of PFS at 5 years, 26.0% vs. 8.5%; HR for disease progression, 0.64; 95% CI, 0.47-0.86).","['advanced ovarian cancer (OC) patients', 'advanced ovarian cancer', '218 patients with FIGO IIIC-IV OC']","['dose-dense early postoperative intraperitoneal chemotherapy', 'Dose-dense early postoperative intraperitoneal chemotherapy (DD-EPIC', 'DD-EPIC followed by intravenous (IV) chemotherapy (DD-EPIC group), or IV chemotherapy alone']","['median OS', 'probability rate of OS', 'Survival benefits', 'progression-free survival (PFS) and OS']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0413365', 'cui_str': 'Intravenous chemotherapy (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",218.0,0.207204,"DD-EPIC was associated with a prolonged PFS compared with the IV group (the estimated rate of PFS at 5 years, 26.0% vs. 8.5%; HR for disease progression, 0.64; 95% CI, 0.47-0.86).","[{'ForeName': 'Tingyan', 'Initials': 'T', 'LastName': 'Shi', 'Affiliation': 'Ovarian Cancer Program, Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Ovarian Cancer Program, Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Pu', 'Affiliation': 'Department of Obstetrics and Gynecology, Wuxi Caner Hospital, Jiangsu, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Gynecologic Oncology, Fudan University Cancer Hospital, Shanghai, China.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Tu', 'Affiliation': ""Department of Mathematics and Statistics, Queen's University, Kingston, Canada.""}, {'ForeName': 'Zhiyuan', 'Initials': 'Z', 'LastName': 'Dai', 'Affiliation': 'Department of Obstetrics and Gynecology, Suzhou Municipal Hospital, Jiangsu, China.'}, {'ForeName': 'Yunlang', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'Department of Obstetrics and Gynecology, Zhongda Hospital Southeast University, Jiangsu, China.'}, {'ForeName': 'Yuqin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Ovarian Cancer Program, Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'Department of Gynecologic Oncology, Fudan University Cancer Hospital, Shanghai, China.'}, {'ForeName': 'Huixun', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'Clinical Statistics Center, Fudan University Cancer Hospital, Shanghai, China.'}, {'ForeName': 'Ruiqin', 'Initials': 'R', 'LastName': 'Tu', 'Affiliation': 'Ovarian Cancer Program, Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Huaying', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecologic Oncology, Fudan University Cancer Hospital, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Department of Gynecologic Oncology, Fudan University Cancer Hospital, Shanghai, China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Luan', 'Affiliation': 'Ovarian Cancer Program, Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Shumo', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': 'Department of Gynecologic Oncology, Fudan University Cancer Hospital, Shanghai, China.'}, {'ForeName': 'Rongyu', 'Initials': 'R', 'LastName': 'Zang', 'Affiliation': 'Ovarian Cancer Program, Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China. ryzang@yahoo.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of cancer,['10.1038/s41416-019-0543-1']
1765,32017250,Does patient expectancy account for the cognitive and clinical benefits of mindfulness training in older adults?,"OBJECTIVES


Patient expectations of treatment effects could influence neuropsychological and clinical outcomes in clinical trials of behavioral and lifestyle interventions, which could potentially confound the interpretation of findings. Our aim was to examine whether patient expectancy mediated effectiveness of Mindfulness-Based Stress Reduction (MBSR) for improving cognitive function and clinical outcome.
METHODS


The present study uses data from a single-blind, multi-site, randomized controlled trial comparing MBSR to a health education attention control in older adults with anxiety and/or depressive disorders and subjective cognitive concerns. Using the Credibility and Expectations Questionnaire, we measured expectancy and perceived credibility of the interventions assigned to patients. Using mediational analysis, we examined the influence of expectancy and credibility on two key outcomes: memory performance and clinical global improvement.
RESULTS


Neither expectancy nor perceived credibility of intervention accounted significantly for MBSR's effectiveness for memory test performance or clinical global improvement.
CONCLUSION


In this clinical trial, expectancy for improvement did not account for the effectiveness of MBSR on memory performance or clinical outcomes in depressed and anxious older adults. We advise that clinical trials of behavioral and lifestyle interventions for brain health in older adults should measure and test the role of expectancy.",2020,"Neither expectancy nor perceived credibility of intervention accounted significantly for MBSR's effectiveness for memory test performance or clinical global improvement.
","['older adults', 'depressed and anxious older adults', 'older adults with anxiety and/or depressive disorders and subjective cognitive concerns']","['behavioral and lifestyle interventions', 'mindfulness training', 'Mindfulness Based Stress Reduction (MBSR) to a health education attention control', 'MBSR', 'Mindfulness Based Stress Reduction']",['Credibility and Expectations Questionnaire (CEQ'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0018701'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.056748,"Neither expectancy nor perceived credibility of intervention accounted significantly for MBSR's effectiveness for memory test performance or clinical global improvement.
","[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Haddad', 'Affiliation': 'Department of Psychiatry, Healthy Mind Lab, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': 'Department of Psychiatry, Healthy Mind Lab, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Ginger', 'Initials': 'G', 'LastName': 'Nicol', 'Affiliation': 'Department of Psychiatry, Healthy Mind Lab, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Yingling', 'Affiliation': 'Department of Psychiatry, Healthy Mind Lab, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Julie Loebach', 'Initials': 'JL', 'LastName': 'Wetherell', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego, CA, USA.'}]",International journal of geriatric psychiatry,['10.1002/gps.5279']
1766,16053461,Sertraline and alprazolam in the treatment of panic desorder.,"A compared, 12 week, placebo controlled study, with fixed dose, outpatient study of patients diagnosed with panic disorder with and without agoraphobia according to ICD-10, was conducted to evaluate the efficacy and safety of sertraline and alprazolam. The study included 40 patients, divided in two groups. We evaluated number of ICD-10-defined panic attacks, agoraphobia and anticipatory anxiety. All patients were aged 18 year and older and were randomized to either sertraline or alprazolam. Sertraline applied in fixed doses of 20 mg/day and alprazolam in doses 1-1,5 mg/day significantly reduced the frequency of panic attacks in panic disorder patients, reduced symptoms of agoraphobia and anticipatory anxiety.",2005,All patients were aged 18 year and older and were randomized to either sertraline or alprazolam.,"['All patients were aged 18 year and older', 'patients diagnosed with panic disorder with and without agoraphobia according to ICD-10', '40 patients, divided in two groups', 'panic desorder', 'panic disorder patients']","['Sertraline and alprazolam', 'placebo', 'Sertraline', 'sertraline and alprazolam', 'alprazolam', 'sertraline or alprazolam']","['symptoms of agoraphobia and anticipatory anxiety', 'efficacy and safety', 'ICD-10-defined panic attacks, agoraphobia and anticipatory anxiety', 'frequency of panic attacks']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030319', 'cui_str': 'Panic Disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030318', 'cui_str': 'Panic'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0002333', 'cui_str': 'Alprazolam'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0231397', 'cui_str': 'Anticipatory anxiety (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0086769', 'cui_str': 'Panic Attacks'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",40.0,0.0247732,All patients were aged 18 year and older and were randomized to either sertraline or alprazolam.,"[{'ForeName': 'Saida', 'Initials': 'S', 'LastName': 'Fiseković', 'Affiliation': 'Psychiatric Clinic, University of Sarajevo Clinics Center, Bolnicka 25, 71 000, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Svjetlana', 'Initials': 'S', 'LastName': 'Loga-Zec', 'Affiliation': ''}]",Bosnian journal of basic medical sciences,[]
1767,31201218,"A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study of Sodium Zirconium Cyclosilicate for Reducing the Incidence of Predialysis Hyperkalemia.","BACKGROUND


Patients with ESRD have minimal renal potassium excretion and, despite hemodialysis, often have persistent predialysis hyperkalemia. The DIALIZE study (NCT03303521) evaluated sodium zirconium cyclosilicate (SZC) in the management of hyperkalemia in hemodialysis patients.
METHODS


In the DIALIZE study, a double-blind, placebo-controlled, phase 3b multicenter study, we randomized adults with ESRD who were managed by three-times weekly hemodialysis and had predialysis hyperkalemia to receive placebo or SZC 5 g once daily on non-dialysis days, and titrated towards maintaining normokalemia over 4 weeks, in 5 g increments to a maximum of 15 g. The primary efficacy outcome was proportion of patients during the 4-week stable-dose evaluation period who maintained predialysis serum potassium of 4.0-5.0 mmol/L during at least three of four hemodialysis treatments after the long interdialytic interval and did not require urgent rescue therapy to reduce serum potassium.
RESULTS


In total, 196 patients (mean [standard deviation (SD)] age =58.1 [13.7] years old) were randomized to sodium zirconium cyclosilicate or placebo. Of 97 patients receiving sodium zirconium cyclosilicate, 41.2% met the primary end point and were deemed treatment responders compared with 1.0% of 99 patients receiving placebo ( P <0.001). Rescue therapy to reduce serum potassium during the treatment period was required by 2.1% of patients taking sodium zirconium cyclosilicate versus 5.1% taking placebo. Serious adverse events occurred in 7% and 8% of patients in sodium zirconium cyclosilicate and placebo groups, respectively. The two groups displayed comparable interdialytic weight gain. There were few episodes of hypokalemia.
CONCLUSIONS


Sodium zirconium cyclosilicate is an effective and well-tolerated treatment for predialysis hyperkalemia in patients with ESRD undergoing adequate hemodialysis.",2019,"Serious adverse events occurred in 7% and 8% of patients in sodium zirconium cyclosilicate and placebo groups, respectively.","['adults with ESRD who were managed by three-times weekly hemodialysis and had predialysis hyperkalemia to receive', 'patients with ESRD undergoing adequate hemodialysis', '196 patients (mean [standard deviation (SD', '97 patients receiving', 'hemodialysis patients', 'Patients with ESRD', 'age =58.1 [13.7] years old']","['sodium zirconium cyclosilicate (SZC', 'placebo', 'placebo or SZC 5', 'Placebo', 'sodium zirconium cyclosilicate', 'Sodium zirconium cyclosilicate', 'sodium zirconium cyclosilicate or placebo', 'Sodium Zirconium Cyclosilicate']","['interdialytic weight gain', 'proportion of patients during the 4-week stable-dose evaluation period who maintained predialysis serum potassium', 'hypokalemia', 'Serious adverse events', 'Incidence of Predialysis Hyperkalemia', 'serum potassium']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C4045824', 'cui_str': 'sodium zirconium cyclosilicate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0020621', 'cui_str': 'Hypopotassemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}]",196.0,0.250443,"Serious adverse events occurred in 7% and 8% of patients in sodium zirconium cyclosilicate and placebo groups, respectively.","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Fishbane', 'Affiliation': 'Department of Medicine, Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York; Sfishbane@northwell.edu.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ford', 'Affiliation': ""Department of Renal Medicine, King's College Hospital NHS Trust, London, United Kingdom.""}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Fukagawa', 'Affiliation': 'Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Japan.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'McCafferty', 'Affiliation': 'Department of Nephrology, Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'Anjay', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Spinowitz', 'Affiliation': 'Department of Medicine, New York-Presbyterian Queens, Queens, New York.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Staroselskiy', 'Affiliation': 'Department #2, B. Braun Avitum Russland Clinics, St. Petersburg, Russia.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Vishnevskiy', 'Affiliation': 'Propedeutics of Internal Diseases Chair, First Pavlov State Medical University of St. Petersburg, St. Petersburg, Russia.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Lisovskaja', 'Affiliation': 'Biometrics and Information and.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Al-Shurbaji', 'Affiliation': 'Global Medicines Development, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Guzman', 'Affiliation': 'Global Medicines Development, AstraZeneca, Gaithersburg, Maryland; and.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Bhandari', 'Affiliation': 'Department of Renal and Transplant Medicine, Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2019050450']
1768,31518717,Magnetic Sphincter Augmentation Superior to Proton Pump Inhibitors for Regurgitation in a 1-Year Randomized Trial.,"BACKGROUND & AIMS


Regurgitative gastroesophageal reflux disease (GERD) refractive to medical treatment is common and caused by mechanical failure of the anti-reflux barrier. We compared the effects of magnetic sphincter augmentation (MSA) with those of proton-pump inhibitors (PPIs) in a randomized trial.
METHODS


Patients with moderate to severe regurgitation (assessed by the foregut symptom questionnaire) despite once-daily PPI therapy (n = 152) were randomly assigned to groups given twice-daily PPIs (n = 102) or laparoscopic MSA (n = 50) at 20 sites, from July 2015 through February 2017. Patients answered questions from the foregut-specific reflux disease questionnaire and GERD health-related quality of life survey about regurgitation, heartburn, dysphagia, bloating, diarrhea, flatulence, and medication use, at baseline and 6 and 12 months after treatment. Six months after PPI therapy, MSA was offered to patients with persistent moderate to severe regurgitation and excess reflux episodes during impedance or pH testing on medication. Regurgitation, foregut scores, esophageal acid exposure, and adverse events were evaluated at 1 year.
RESULTS


Patients in the MSA group and those who crossed over to the MSA group after PPI therapy (n = 75) had similar outcomes. MSA resulted in control of regurgitation in 72/75 patients (96%); regurgitation control was independent of preoperative response to PPIs. Only 8/43 patients receiving PPIs (19%) reported control of regurgitation. Among the 75 patients who received MSA, 61 (81%) had improvements in GERD health-related quality of life improvement scores (greater than 50%) and 68 patients (91%) discontinued daily PPI use. Proportions of patients with dysphagia decreased from 15% to 7% (P < .005), bloating decreased from 55% to 25%, and esophageal acid exposure time decreased from 10.7% to 1.3% (P < .001) from study entry to 1-year after MSA (Combined P < .001). Seventy percent (48/69) of patients had pH normalization at study completion. MSA was not associated with any peri-operative events, device explants, erosions, or migrations.
CONCLUSIONS


In a prospective study, we found MSA to reduce regurgitation in 95% of patients with moderate to severe regurgitation despite once-daily PPI therapy. MSA is superior to twice-daily PPIs therapy in reducing regurgitation. Relief of regurgitation is sustained over 12 months. ClinicalTrials.gov no: NCT02505945.",2019,"Proportions of patients with dysphagia decreased from 15% to 7% (P<.005), bloating decreased from 55% to 25%, and esophageal acid exposure time decreased from 10.7% to 1.3% (P<.001) from study entry to 1-year after MSA (Combined P<.001).","['Patients with moderate to severe regurgitation (assessed by the foregut symptom questionnaire) despite once-daily PPI therapy (n=152', 'patients with moderate to severe regurgitation despite once-daily PPI therapy', 'n=50) at 20 sites, from July 2015 through February 2017', 'Regurgitative gastroesophageal reflux disease (GERD']","['Magnetic Sphincter Augmentation Superior to Proton Pump Inhibitors', 'twice-daily PPIs', 'PPI therapy', 'MSA', 'proton-pump inhibitors (PPIs', 'laparoscopic MSA', 'magnetic sphincter augmentation (MSA', 'PPI therapy, MSA']","['peri-operative events, device explants, erosions, or migrations', 'control of regurgitation', 'Proportions of patients with dysphagia', 'GERD health-related quality of life improvement scores', 'bloating', 'regurgitation', 'foregut-specific reflux disease questionnaire and GERD health-related quality of life survey about regurgitation, heartburn, dysphagia, bloating, diarrhea, flatulence, and medication use', 'Regurgitation, foregut scores, esophageal acid exposure, and adverse events', 'esophageal acid exposure time', 'severe regurgitation and excess reflux episodes', 'Relief of regurgitation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0460152', 'cui_str': 'Regurgitation - mechanism (qualifier value)'}, {'cui': 'C0231051', 'cui_str': 'Primitive foregut structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer (morphologic abnormality)'}, {'cui': 'C1533574', 'cui_str': 'Migration, function (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0460152', 'cui_str': 'Regurgitation - mechanism (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1291077', 'cui_str': 'Abdomen feels bloated'}, {'cui': 'C0231051', 'cui_str': 'Primitive foregut structure'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}]",,0.0512771,"Proportions of patients with dysphagia decreased from 15% to 7% (P<.005), bloating decreased from 55% to 25%, and esophageal acid exposure time decreased from 10.7% to 1.3% (P<.001) from study entry to 1-year after MSA (Combined P<.001).","[{'ForeName': 'Reginald', 'Initials': 'R', 'LastName': 'Bell', 'Affiliation': 'Institute of Esophageal and Reflux Surgery, Englewood, Colorado. Electronic address: reg@iersurgery.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lipham', 'Affiliation': 'Department of Surgery, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Louie', 'Affiliation': 'Division of Thoracic Surgery, Swedish Medical Center, Seattle, Washington.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Williams', 'Affiliation': ""Thoracic Surgery Department, St. Elizabeth's Healthcare, Edgewood, Kentucky.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Luketich', 'Affiliation': 'Division of Thoracic Surgery, University of Pittsburgh Medical Center Health System, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': 'Department of Surgery, Adirondack Medical Center and Adirondack Surgical Group, Saranac Lake, New York.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Richards', 'Affiliation': 'Department of Surgery, University of South Alabama, Mobile, Alabama.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Dunst', 'Affiliation': 'Department of Surgery, Oregon Clinic, Portland, Oregon.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Lister', 'Affiliation': 'Arkansas Heartburn Treatment Center, Baptist Health Medical Center, Heber Springs, Arkansas.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'McDowell-Jacobs', 'Affiliation': 'Department of Surgery, Knox Community Hospital, Mount Vernon, Ohio.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Reardon', 'Affiliation': 'Department of Surgery, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Woods', 'Affiliation': 'Department of Medicine, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Gould', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'F Paul', 'Initials': 'FP', 'LastName': 'Buckley', 'Affiliation': 'Department of Surgery and Perioperative Care, University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Shanu', 'Initials': 'S', 'LastName': 'Kothari', 'Affiliation': 'Department of Surgery, Prisma Health, Greenville, South Carolina.'}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Khaitan', 'Affiliation': 'Department of Surgery, Digestive Health Institute, University Hospitals, Cleveland Medical Center, Cleveland, Cleveland, Ohio.'}, {'ForeName': 'C Daniel', 'Initials': 'CD', 'LastName': 'Smith', 'Affiliation': 'Esophageal Institute of Atlanta, Atlanta, Georgia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Anne Arundel Health System and Johns Hopkins Medicine, Annapolis, Maryland.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'Albany Surgical PC, Albany, Georgia.'}, {'ForeName': 'Garth', 'Initials': 'G', 'LastName': 'Jacobsen', 'Affiliation': 'Department of Surgery, University of California, San Diego, San Diego, California.'}, {'ForeName': 'Ghulam', 'Initials': 'G', 'LastName': 'Abbas', 'Affiliation': 'Division of Thoracic Surgery, West Virginia University School of Medicine, Morgantown, West Virginia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Katz', 'Affiliation': 'Department of Gastroenterology, Weill Cornell Medicine, New York, New York.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.08.056']
1769,31785594,Neonatal encephalopathy therapy optimization for better neuroprotection with inhalation of CO 2 : the HENRIC feasibility and safety trial.,"BACKGROUND


There is an association between hypocapnia and adverse neurodevelopmental outcome in infants with neonatal encephalopathy (NE). Our aim was to test the safety and feasibility of 5% CO 2  and 95% air inhalation to correct hypocapnia in mechanically ventilated infants with NE undergoing therapeutic hypothermia.
METHODS


Ten infants were assigned to this open-label, single-center trial. The gas mixture of 5% CO 2  and 95% air was administered through patient circuits if the temperature-corrected PCO 2  ≤40 mm Hg. The CO 2  inhalation was continued for 12 h or was stopped earlier if the base deficit (BD) level decreased <5 mmol/L. Follow-up was performed using Bayley Scales of Infant Development II.
RESULTS


The patients spent a median 95.1% (range 44.6-98.5%) of time in the desired PCO 2  range (40-60 mm Hg) during the inhalation. All PCO 2  values were >40 mm Hg, the lower value of the target range. Regression modeling revealed that BD and lactate had a tendency to decrease during the intervention (by 0.61 and 0.55 mmol/L/h, respectively), whereas pH remained stable. The rate of moderate disabilities and normal outcome was 50%.
CONCLUSIONS


Our results suggest that inhaled 5% CO 2  administration is a feasible and safe intervention for correcting hypocapnia.",2020,"Regression modeling revealed that BD and lactate had a tendency to decrease during the intervention (by 0.61 and 0.55 mmol/L/h, respectively), whereas pH remained stable.","['mechanically ventilated infants with NE undergoing therapeutic hypothermia', 'infants with neonatal encephalopathy (NE']",[],"['rate of moderate disabilities and normal outcome', 'safety and feasibility']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0020674', 'cui_str': 'Targeted Temperature Management'}, {'cui': 'C0235820', 'cui_str': 'Neonatal encephalopathy (disorder)'}]",[],"[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.143105,"Regression modeling revealed that BD and lactate had a tendency to decrease during the intervention (by 0.61 and 0.55 mmol/L/h, respectively), whereas pH remained stable.","[{'ForeName': 'Eniko', 'Initials': 'E', 'LastName': 'Szakmar', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Kata', 'Initials': 'K', 'LastName': 'Kovacs', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Unoke', 'Initials': 'U', 'LastName': 'Meder', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Geza', 'Initials': 'G', 'LastName': 'Bokodi', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Csilla', 'Initials': 'C', 'LastName': 'Andorka', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lakatos', 'Affiliation': 'MR Research Centre, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Attila J', 'Initials': 'AJ', 'LastName': 'Szabo', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Gusztav', 'Initials': 'G', 'LastName': 'Belteki', 'Affiliation': 'Neonatal Intensive Care Unit, Cambridge University Hospitals NHS Trust, Cambridge, UK.'}, {'ForeName': 'Miklos', 'Initials': 'M', 'LastName': 'Szabo', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Jermendy', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary. jermendy.agnes@med.semmelweis-univ.hu.'}]",Pediatric research,['10.1038/s41390-019-0697-9']
1770,31707770,Individuals With Recurrent Low Back Pain Exhibit Significant Changes in Paraspinal Muscle Strength After Intramuscular Fine Wire Electrode Insertion.,"OBJECTIVE


To examine how insertion and presence of intramuscular fine-wire electromyography electrodes (IFWEs) in lumbar multifidus affect paraspinal muscle strength, endurance, and activation in persons with and without recurrent lower back pain (RLBP) during activities that require high levels of muscle contraction.
DESIGN


Case-control with randomization of conditions.
SETTING


Clinical research laboratory.
PARTICIPANTS


Forty participants age 18 to 40 years were recruited (18 female; mean age = 25.5 years); 20 with a history of RLBP were compared to a matching control group of 20 without RLBP.
INTERVENTIONS


Each participant was tested under three conditions over three sessions. On Session 1, the baseline condition, we assessed muscle performance without IFWE insertion. On Sessions 2 and 3, participants were randomly alternated between two experimental conditions: (1) wire-in, in which the IFWE was inserted and remained within the muscle during testing; and (2) wire-out, in which the IFWE was inserted and immediately removed.
MAIN OUTCOME MEASUREMENTS


Lumbar spinal extensor peak strength, endurance, and normalized electromyography (EMG) amplitude during the endurance test.
RESULTS


Individuals with RLBP showed a significant decrease in peak strength during conditions that involved IFWE insertion and tend to experience more pain during muscle testing. Both groups exhibited similar levels of performance and muscle activation during the endurance test.
CONCLUSION


Our findings indicate that individuals with RLBP exhibited reduced lumbar extensor strength in response to IFWE insertion to the deep paraspinal muscles. This behavior is different from those without RLBP. Researchers should carefully consider the use of IFWE in individuals with RLBP during high exertion activities.",2019,"Both groups exhibited similar levels of performance and muscle activation during the endurance test.
","['persons with and without recurrent lower back pain (RLBP', 'individuals with RLBP during high exertion activities', 'Forty participants age 18-40 were recruited (18 female; mean age\u2009=\u200925.5\u2009yr); 20 with a history of RLBP']","['intramuscular fine-wire electromyography electrodes (IFWE', 'matching control group of 20 without RLBP']","['Paraspinal Muscle Strength', 'performance and muscle activation', 'peak strength', 'Lumbar spinal extensor peak strength, endurance, and normalized EMG amplitude during the endurance test', 'lumbar extensor strength']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517663', 'cui_str': 'Twenty-five point five'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C0005978', 'cui_str': 'Bone Wires'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0013812', 'cui_str': 'Electrode, device (physical object)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0448353', 'cui_str': 'Deep Muscles of the Back'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0429340', 'cui_str': 'EMG amplitude'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",40.0,0.0413105,"Both groups exhibited similar levels of performance and muscle activation during the endurance test.
","[{'ForeName': 'Szu-Ping', 'Initials': 'SP', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, University of Nevada, Las Vegas, NV.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Dinglasan', 'Affiliation': 'Department of Physical Therapy, University of Nevada, Las Vegas, NV.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Duong', 'Affiliation': 'Department of Physical Therapy, University of Nevada, Las Vegas, NV.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Totten', 'Affiliation': 'Department of Physical Therapy, University of Nevada, Las Vegas, NV.'}, {'ForeName': 'Jo A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'Department of Physical Therapy, Chapman University, Orange, CA.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12284']
1771,30631933,Laparoscopic vagal nerve blocking device explantation: case series and report of operative technique.,"BACKGROUND


Vagal nerve blockade with the vBloc device (ReShape Lifesciences, St. Paul, MN) has been shown to provide durable 2-year weight loss in patients with moderate obesity. These devices may require removal. We present a series of patients and report our technique for laparoscopic removal of this device.
METHODS


From December 2009 to December 2016, the medical records of patients who underwent laparoscopic explantation of a vagal blocking device at our institution were retrospectively reviewed. All patients initially underwent device placement as part of a multi-center, randomized, controlled trial. The device leads were removed with the application of firm traction in order to safely dissect them away from the stomach and esophagus as the body tended to form a fibrotic capsule surrounding the leads. Operative details, length of stay, 30-day post-operative complications, demographics and reasons for device removal were reported.
RESULTS


Thirty patients were identified. Median age was 54 (37-65) years. Average operative time was 227.63 (± 100.21) min. Median time from implantation to removal was 41 (11-96) months. Removal reasons included device malfunction (7 patients, 23.3%), pain at the neuroregulator site (5 patients, 16.7%), retrosternal or epigastric pain (11 patients, 36.7%), weight regain or dissatisfaction with weight loss (15 patients, 50%), and severe nausea (2 patients, 6.7%). Two patients (6.7%) had Clavien-Dindo grade II complications following explantation. Thirteen patients (43.3%) had dense adhesions noted at the time of operation. Seroma formation at the neuroregulator site was the most common complication (7 patients, 23.3%).
CONCLUSION


The vagal nerve blocking device can be safely removed laparoscopically with a low 30-day complication rate. Surgeons should be familiar with the details of the device appearance, the typical lead location, and should anticipate dense adhesions surrounding the leads. In addition, experience operating in the region of the gastroesophageal junction is imperative.",2019,"Seroma formation at the neuroregulator site was the most common complication (7 patients, 23.3%).
","['patients with moderate obesity', 'Median age was 54 (37-65)\xa0years', 'From December 2009 to December 2016, the medical records of patients who underwent laparoscopic explantation of a vagal blocking device at our institution were retrospectively reviewed', 'Thirty patients were identified']","['device placement', 'Laparoscopic vagal nerve blocking device explantation']","['Median time from implantation to removal', 'Clavien-Dindo grade II complications', 'Average operative time', 'severe nausea', 'retrosternal or epigastric pain', 'weight regain or dissatisfaction with weight loss', 'Seroma formation', 'pain at the neuroregulator site', 'Operative details, length of stay, 30-day post-operative complications, demographics and reasons for device removal', 'device malfunction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0025102', 'cui_str': 'Medical Records'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}]","[{'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0442179', 'cui_str': 'Retrosternal (qualifier value)'}, {'cui': 'C0232493', 'cui_str': 'Epigastric pain (finding)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0949371', 'cui_str': 'Neuroregulators'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0752250', 'cui_str': 'Device Removal'}, {'cui': 'C1504465', 'cui_str': 'Device malfunction'}]",30.0,0.0654562,"Seroma formation at the neuroregulator site was the most common complication (7 patients, 23.3%).
","[{'ForeName': 'Tarin C', 'Initials': 'TC', 'LastName': 'Worrest', 'Affiliation': 'Department of Surgery, Oregon Health and Science University, 3181 SW Sam Jackson Park Rd, Mail Code L223A, Portland, OR, 97239, USA.'}, {'ForeName': 'Bruce M', 'Initials': 'BM', 'LastName': 'Wolfe', 'Affiliation': 'Department of Surgery, Oregon Health and Science University, 3181 SW Sam Jackson Park Rd, Mail Code L223A, Portland, OR, 97239, USA.'}, {'ForeName': 'Samer G', 'Initials': 'SG', 'LastName': 'Mattar', 'Affiliation': 'Swedish Medical Center Bariatric, Metabolic, and Endocrine Center, 1124 Columbia Street Suite 400, Seattle, WA, 98104, USA.'}, {'ForeName': 'Erin W', 'Initials': 'EW', 'LastName': 'Gilbert', 'Affiliation': 'Department of Surgery, Oregon Health and Science University, 3181 SW Sam Jackson Park Rd, Mail Code L223A, Portland, OR, 97239, USA. gilberte@ohsu.edu.'}]",Surgical endoscopy,['10.1007/s00464-018-06643-4']
1772,31345778,"Norursodeoxycholic acid versus placebo in the treatment of non-alcoholic fatty liver disease: a double-blind, randomised, placebo-controlled, phase 2 dose-finding trial.","BACKGROUND


Norursodeoxycholic acid is an orally administered side chain-shortened homologue of ursodeoxycholic acid that undergoes hepatic enrichment with hepatoprotective, anti-inflammatory, and antifibrotic activity. We assessed the efficacy of two doses of norursodeoxycholic acid versus placebo for the treatment of non-alcoholic fatty liver disease.
METHODS


We did a multicentre, double-blind, placebo-controlled, randomised, phase 2 dose-finding clinical trial in tertiary referral hospitals and medical centres in Austria (n=6) and Germany (n=23) for patients with non-alcoholic fatty liver disease with or without diabetes. Patients with a clinical diagnosis of non-alcoholic fatty liver disease and serum alanine aminotransferase (ALT) concentrations of more than 0·8 times the upper limit of normal were randomly assigned (1:1:1) using a computer-generated central randomisation. Patients were randomly assigned to receive either norursodeoxycholic acid capsules at 500 mg per day or 1500 mg per day, or placebo, for 12 weeks with a subsequent 4-week follow-up period. All individuals involved in the trial were masked to treatment allocation. The primary efficacy endpoint was the mean relative percentage change in ALT concentrations between baseline and end of treatment assessed in the intention-to-treat population. This trial is registered with EudraCT, number 2013-004605-38.
FINDINGS


Between March 30, 2015, and Sept 20, 2016, of 198 individuals included in the analysis, 67 patients were randomly assigned to receive 500 mg norursodeoxycholic acid, 67 to 1500 mg norursodeoxycholic acid, and 64 to placebo. A dose-dependent reduction in serum ALT between baseline and end of treatment was observed with norursodeoxycholic acid versus placebo, with a significant effect in the 1500 mg group (mean change -27·8%, 95% repeated CI -34·7 to -14·4; p<0·0001). Serious adverse events (n=6) and treatment-emergent adverse events (n=314) were reported in a similar proportion of patients across groups. 112 treatment-emergent adverse events occurred in the 1500 mg group, 99 in the 500 mg group, and 103 in the placebo group. The most frequent adverse events were headache, gastrointestinal disorders, and infections (eg, diarrhoea, abdominal pain, or nasopharyngitis).
INTERPRETATION


Norursodeoxycholic acid at 1500 mg resulted in a significant reduction of serum ALT within 12 weeks of treatment when compared with placebo. Norursodeoxycholic acid was safe and well tolerated encouraging further studies.
FUNDING


Dr Falk Pharma GmbH.",2019,Norursodeoxycholic acid at 1500 mg resulted in a significant reduction of serum ALT within 12 weeks of treatment when compared with placebo.,"['Between March 30, 2015, and Sept 20, 2016, of 198 individuals included in the analysis, 67 patients', 'non-alcoholic fatty liver disease', 'tertiary referral hospitals and medical centres in Austria (n=6) and Germany (n=23) for patients with non-alcoholic fatty liver disease with or without diabetes', 'Patients with a clinical diagnosis of non-alcoholic fatty liver disease and serum alanine aminotransferase (ALT) concentrations of more than 0·8 times the upper limit of normal']","['norursodeoxycholic acid, and 64 to placebo', 'Norursodeoxycholic acid', 'placebo', 'norursodeoxycholic acid', 'ursodeoxycholic acid', 'norursodeoxycholic acid capsules', 'norursodeoxycholic acid versus placebo', 'Norursodeoxycholic acid versus placebo']","['headache, gastrointestinal disorders, and infections (eg, diarrhoea, abdominal pain, or nasopharyngitis', 'serum ALT', 'adverse events', 'mean relative percentage change in ALT concentrations', 'Serious adverse events (n=6) and treatment-emergent adverse events']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]","[{'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042105', 'cui_str': 'ursodesoxycholic acid'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",112.0,0.730487,Norursodeoxycholic acid at 1500 mg resulted in a significant reduction of serum ALT within 12 weeks of treatment when compared with placebo.,"[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Traussnigg', 'Affiliation': 'Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University Vienna, Vienna, Austria.'}, {'ForeName': 'Jörn M', 'Initials': 'JM', 'LastName': 'Schattenberg', 'Affiliation': 'Department of Internal Medicine I, University Medical Center of the Johannes-Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Münevver', 'Initials': 'M', 'LastName': 'Demir', 'Affiliation': 'Clinic for Gastroenterology and Hepatology, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Wiegand', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology and Hepatology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Geier', 'Affiliation': 'Department of Medicine II, Division of Hepatology, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Gerlinde', 'Initials': 'G', 'LastName': 'Teuber', 'Affiliation': 'Teuber Consulting & Research UG, Frankfurt, Germany.'}, {'ForeName': 'Wolf Peter', 'Initials': 'WP', 'LastName': 'Hofmann', 'Affiliation': 'Practice for Gastroenterology, Berlin, Germany.'}, {'ForeName': 'Andreas E', 'Initials': 'AE', 'LastName': 'Kremer', 'Affiliation': 'Department of Medicine I, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Spreda', 'Affiliation': 'Practice of Hadem/Spreda, Daaden, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Kluwe', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology and Hepatology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Petersen', 'Affiliation': 'Ifi-Studies and Projects at the Asklepios Clinic St Georg, Hamburg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Boettler', 'Affiliation': 'Department of Medicine II, Medical CenterFaculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Rainer', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology and Hepatology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Emina', 'Initials': 'E', 'LastName': 'Halilbasic', 'Affiliation': 'Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University Vienna, Vienna, Austria.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Greinwald', 'Affiliation': 'Dr Falk Pharma GmbH, Freiburg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Pröls', 'Affiliation': 'Dr Falk Pharma GmbH, Freiburg, Germany.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Manns', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fickert', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology and Hepatology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Trauner', 'Affiliation': 'Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University Vienna, Vienna, Austria. Electronic address: michael.trauner@meduniwien.ac.at.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30184-0']
1773,31504831,The Presence and Persistence of Unrealistic Expectations in Patients Undergoing Nerve Surgery.,"BACKGROUND


Unrealistic expectations of the outcomes of peripheral nerve surgery reduce patient satisfaction. Most clinicians can recall patients with unrealistic expectations despite verbal preoperative education.
OBJECTIVE


To assess patients' baseline level of understanding regarding nerve surgery and appropriate expectations. Additionally, we tested the effect of a written, preoperative educational handout on the patients' retention of knowledge.
METHODS


This cross-sectional survey recruited patients scheduled to undergo peripheral nerve surgery at a single institution in 2016 to 2017. During the preoperative visit, a specialized nurse practitioner reviewed perioperative protocols, risks and benefits of the surgery, and postoperative care. Patients immediately completed a survey to assess their preoperative understanding of the verbally reviewed information. During the same visit, an additional written handout was given to patients in a randomized fashion. At their first postoperative visit, all patients completed the survey again.
RESULTS


A total of 60 patients (mean age 52 yr) were enrolled of which 62% were male. Immediately following verbal instruction, 31% of patients had erroneous (unrealistic) expectations regarding pain, 30% had erroneous expectations regarding postoperative motor outcome, and 41% had erroneous expectations regarding the timing of postoperative recovery. There was no significant difference between patients who received the written handout vs those who did not, on retesting in the postoperative period.
CONCLUSION


Patients undergoing peripheral nerve procedures demonstrated a high baseline level of unrealistic expectations despite standard in-person verbal counseling by specialty providers. A written handout did not have clear benefit in the retention of preoperative surgical teaching. Further investigation into more effective preoperative patient counseling is needed.",2020,"There was no significant difference between patients who received the written handout vs those who did not, on retesting in the postoperative period.
","['Patients Undergoing Nerve Surgery', 'patients scheduled to undergo peripheral nerve surgery at a single institution in 2016 to 2017', '60 patients (mean age 52 yr) were enrolled of which 62% were male']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0031119', 'cui_str': 'Peripheral Nerves'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}]",[],[],,0.067368,"There was no significant difference between patients who received the written handout vs those who did not, on retesting in the postoperative period.
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kirsch', 'Affiliation': 'School of Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'Department of Neurosurgery, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Brandon W', 'Initials': 'BW', 'LastName': 'Smith', 'Affiliation': 'Department of Neurosurgery, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Kate W C', 'Initials': 'KWC', 'LastName': 'Chang', 'Affiliation': 'Department of Neurosurgery, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Sravanthi', 'Initials': 'S', 'LastName': 'Koduri', 'Affiliation': 'Department of Neurosurgery, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Lynda J S', 'Initials': 'LJS', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery, University of Michigan, Ann Arbor, Michigan.'}]",Neurosurgery,['10.1093/neuros/nyz335']
1774,15523163,"A prospective, randomised, double-blind study of comparative efficacy of immediate versus daily cleaning of stethoscope using 66% ethyl alcohol.","OBJECTIVE


Studies have demonstrated frequent contamination of stethoscope and usefulness of different disinfectants. Albeit, studies on the precise mode of cleaning and frequency of cleaning are lacking. This study was carried out to determine efficacy of 66% ethyl alcohol as disinfectant, rate of recontamination without cleaning and benefits of daily versus immediate cleaning.
METHODOLOGY


Prospective, randomised, double blind study of 100 stethoscopes. Four cultures were obtained: before cleaning (Group A), immediately after cleaning with 66% ethyl alcohol (Group B), at the end of 4 days without cleaning (Group C) and at the end of 4 days after cleaning once a day (Group D). Samples were analysed using standard microbiological methods and Colony-forming unit (CFU) count and residual microorganism was computed for all the positive cultures. Medical staff was asked about the cleaning practices. Statistical analysis was carried out using 95% confidence interval and Chi-square test.
RESULTS


90% of the stethoscopes were contaminated with one or more microorganisms. Immediate cleaning and daily cleaning were associated with a significant reduction in the rate of contamination to 28% and 25% respectively. CFU count in groups B and D dropped to less than 10 in 75% and 84.7%, while the mean residual rates were 5.2% and 3.65% respectively. Groups B and D showed no statistically significant difference in terms of efficacy of disinfection.
CONCLUSIONS


66% ethyl alcohol is an effective disinfectant. The effects of immediate cleaning and cleaning once a day on residual flora on the diaphragm of stethoscope is comparable.",2004,Immediate cleaning and daily cleaning were associated with a significant reduction in the rate of contamination to 28% and 25% respectively.,['100 stethoscopes'],"['ethyl alcohol', 'immediate cleaning and cleaning', 'immediate versus daily cleaning of stethoscope using 66% ethyl alcohol']","['CFU count', 'rate of contamination', 'efficacy of disinfection', 'mean residual rates']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0183559', 'cui_str': 'Stethoscopes'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0183559', 'cui_str': 'Stethoscopes'}]","[{'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}]",4.0,0.0523029,Immediate cleaning and daily cleaning were associated with a significant reduction in the rate of contamination to 28% and 25% respectively.,"[{'ForeName': 'Ramesh C', 'Initials': 'RC', 'LastName': 'Parmar', 'Affiliation': 'The Department of Paediatrics, Seth G.S. Medical College & K.E.M. Hospital, Parel, Mumbai-400 012, India. ramehsparmar@yahoo.com'}, {'ForeName': 'Chayya C', 'Initials': 'CC', 'LastName': 'Valvi', 'Affiliation': ''}, {'ForeName': 'Poonam', 'Initials': 'P', 'LastName': 'Sira', 'Affiliation': ''}, {'ForeName': 'Jaishree R', 'Initials': 'JR', 'LastName': 'Kamat', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1775,15470281,Microbial and cytopathological study of intrauterine contraceptive device users.,"CONTEXT


Intrauterine contraceptive device (IUCD) is a commonly used birth-spacing method which is fitted into maternal system. Clinical, microbial and cytopathological monitoring of women using these devices are important for ascertaining their side effects, risk of genital tract infection and carcinogenic potential.
AIMS


To study clinical, microbial and cytopathological changes in IUCD users in a tertiary care hospital.
DESIGN


Prospective analytic.
SETTING


Tertiary hospital.
MATERIAL AND METHODS


women visiting Family Planning clinic for follow up (IUCD users, n=100) or for IUCD insertion (controls, n=50) were enrolled in the study. Each subject underwent detailed history, general physical, systemic, and per local examination. Vaginal discharge was subjected to pH testing, KOH and wet mount examination, gram staining, and for culture and sensitivity. Bacterial vaginosis was defined using Nugent criteria. Cervical smears were examined and reported as per Bethesda system.
STATISTICAL ANALYSIS


The information was entered into Microsoft Excel spreadsheet. The results were analyzed using EPI Info version-6 and Stata statistical software version 7 packages. Two-tailed t-test, chi2 test with Yates correction and two-tailed Fisher Exact tests were applied.
RESULTS


Most women used CuT 200 (92%). Median duration of use was 2 years. Chief complaints of IUCD users included backache (54%), vaginal discharge (46%), pain lower abdomen (34%), dyspareunia (22%), menorrhagia (18%) and dysmenorrhea (14%). Mean hemoglobin was lower in IUCD users than controls (11.2+/-1.7 versus 11.9+/-1.8 g/dL, p 0.02). Proportion of women with anemia was higher in IUCD users than in controls (29% versus 16%, p 0.12). Cervical erosion was significantly increased in study group as compared the controls (20% versus 0%, p=0.00) whereas only insignificant increase in vaginitis (6% versus 0%, p=0.17). Trichomonas vaginalis and fungal hyphae positivity and gram stain findings and bacterial vaginosis rate were not significantly different in two groups. Vaginal discharge bacterial culture revealed comparable results in two groups. Cytological findings were predominantly inflammatory. None of cases revealed Actinomycosis infection. High-grade squamous intraepithelial lesion (n=2) and low grade squamous intraepithelial lesion (n=1) cytological finding were present in IUCD users compared to none in controls. None of the cases had any malignant transformation.
CONCLUSION


IUCD use results in lower hemoglobin concentration and cervical erosion. Women using IUCD requires a regular follow up, clinical examination, counseling and further investigation if required.",2004,Trichomonas vaginalis and fungal hyphae positivity and gram stain findings and bacterial vaginosis rate were not significantly different in two groups.,"['IUCD users in a tertiary care hospital', 'Tertiary hospital', 'High-grade squamous intraepithelial lesion (n=2) and low grade squamous intraepithelial lesion (n=1', 'intrauterine contraceptive device users', 'women visiting Family Planning clinic for follow up (IUCD users, n=100) or for IUCD insertion (controls, n=50) were enrolled in the study']","['Intrauterine contraceptive device (IUCD', 'IUCD']","['Proportion of women with anemia', 'Cervical erosion', 'vaginitis', 'vaginal discharge', 'dysmenorrhea', 'Mean hemoglobin', 'pain lower abdomen', 'dyspareunia', 'Trichomonas vaginalis and fungal hyphae positivity and gram stain findings and bacterial vaginosis rate', 'Vaginal discharge bacterial culture', 'Actinomycosis infection', 'hemoglobin concentration and cervical erosion', 'menorrhagia', 'backache', 'Bacterial vaginosis', 'Vaginal discharge', 'Median duration of use']","[{'cui': 'C0021900', 'cui_str': 'Contraceptive Devices, Intrauterine'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0333875', 'cui_str': 'HSIL, High-Grade Squamous Intraepithelial Lesions'}, {'cui': 'C1302773', 'cui_str': 'Low-Grade Squamous Intraepithelial Lesions'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3840184', 'cui_str': 'Family planning clinic'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0021900', 'cui_str': 'Contraceptive Devices, Intrauterine'}]","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0007869', 'cui_str': 'Uterine Cervical Erosion'}, {'cui': 'C0042267', 'cui_str': 'Vaginitis'}, {'cui': 'C0227791', 'cui_str': 'Vaginal Discharge'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0230166', 'cui_str': 'Lower abdomen structure'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse (finding)'}, {'cui': 'C0040922', 'cui_str': 'Trichomonas vaginalis'}, {'cui': 'C0521057', 'cui_str': 'Hyphas'}, {'cui': 'C0061856', 'cui_str': ""Gram's stain""}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0085166', 'cui_str': 'Vaginitis, Nonspecific'}, {'cui': 'C0430402', 'cui_str': 'Bacterial culture (procedure)'}, {'cui': 'C0001261', 'cui_str': 'Actinomyces Infections'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0025323', 'cui_str': 'Heavy Menstrual Bleeding'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",,0.0617971,Trichomonas vaginalis and fungal hyphae positivity and gram stain findings and bacterial vaginosis rate were not significantly different in two groups.,"[{'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Agarwal', 'Affiliation': 'Department of Obstetrics and Gynaecology, SMS Medical College, Jaipur, India. aranag@rediffmail.com'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Acharya', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1776,15771597,Saturation with oxygen for ductal dependent congenital heart diseases before and after the prostaglandin therapy.,"Ductal dependent congenital heart diseases represent 14-20% of all congenital heart diseases. A primary goal of the treatment of these diseases is to retain ductus open until the final cardiosurgical treatment. Prostaglandins are presently the only medicaments, which have a capability to keep ductus open. By means of a retrospective study in a period from January, 2000 until December, 2002 at the Paediatric clinic of the Clinical centre of the University in Sarajevo, 14 patients (treated with prostaglandins) diagnosed with ductal dependent congenital heart diseases were analyzed. In our sample, there are 9/14 male patients (64.3%), 11/14 (78.6%) were full-term newborns, while 10/14 (71.4%) were eutrophic at birth. An average saturation increase, after the prostaglandin therapy, measured in blood from the capillaries is 29, and measured transcutanlly is 32 units. Duration of prostaglandin therapy in our study was on average 17.2 days. The most common cause of death was insufficientia cardiorespiratoria (4 out of 11), but sepsis/infection (3 out of 11) and insufficientia renalis were also common. 78.6% (11 out of 14) patients died partly because of the complexity of these diseases, but also because a cardiosurgical treatment is delayed. A goal of this study is evaluation of saturation with oxygen before and after the prostaglandin therapy.",2005,"The most common cause of death was insufficientia cardiorespiratoria (4 out of 11), but sepsis/infection (3 out of 11) and insufficientia renalis were also common.","['By means of a retrospective study in a period from January, 2000 until December, 2002 at the Paediatric clinic of the Clinical centre of the University in Sarajevo, 14 patients (treated with prostaglandins) diagnosed with ductal dependent congenital heart diseases were analyzed']",['prostaglandin therapy'],[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Studies'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic (environment)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0356622', 'cui_str': 'Prostaglandins, oxytocics'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease (disorder)'}]","[{'cui': 'C0356622', 'cui_str': 'Prostaglandins, oxytocics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],14.0,0.0237814,"The most common cause of death was insufficientia cardiorespiratoria (4 out of 11), but sepsis/infection (3 out of 11) and insufficientia renalis were also common.","[{'ForeName': 'Senka', 'Initials': 'S', 'LastName': 'Dinarević', 'Affiliation': 'Paediatric clinic of the Clinical Centre of the University of Sarajevo, Bolnicka 25, 71 000 Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Hajrija', 'Initials': 'H', 'LastName': 'Maksić', 'Affiliation': ''}, {'ForeName': 'Majda', 'Initials': 'M', 'LastName': 'Haznadar', 'Affiliation': ''}]",Bosnian journal of basic medical sciences,[]
1777,15286420,A school-based intervention to teach 3-4 grades children about healthy heart; the Persian Gulf healthy heart project.,"BACKGROUND


Cardiovascular health promotion in children has the potential to reduce the risk of atherosclerosis in both the individual child and the population at large. It thus seems eminently reasonable to initiate healthful lifestyle training in childhood to promote improved cardiovascular health in adult life.
AIMS


To test the hypothesis that a year long, classroom-based education for the third and fourth graders could change their knowledge scores about healthy heart.
SETTINGS AND DESIGN


A randomized, controlled trial in elementary schools of Bushehr/Iran.
METHODS AND MATERIALS


A total of 14 elementary schools, categorized by socioeconomic types and male and female setting were selected and randomized into control or intervention groups. Subjects were 1128 third and fourth graders, aged 9 to 10 years (49.1% boys and 50.9% girls). Over a course of 8 weeks, health educators and sport teachers of the elementary schools presented two hours sessions per week on heart function, nutrition, and exercise for healthy heart and living tobacco free for the intervention group. The education program was based on HeartPower! Program, an American Heart Association program.
STATISTICAL ANALYSIS


Mann-Whitney U test and Wilcoxon matched-pairs signed rank test and Bonferroni correction for the two pair wise comparisons were used.
RESULTS


Total heart knowledge at posttest was 25% correct higher in the intervention than in the control group (p< 0.001). Difference in means of total healthy heart knowledge scores between control and intervention group increased from 1.43 points in baseline to 4.02 points in posttest (p< 0.001).
CONCLUSION


It can be concluded that the classroom-based cardiovascular health promotion had a significant effect on the heart healthy knowledge. Therefore, schools provide an excellent setting for introducing comprehensive healthy heart education and promotion of cardiovascular health to the general population.",2004,"RESULTS


Total heart knowledge at posttest was 25% correct higher in the intervention than in the control group (p< 0.001).","['elementary schools of Bushehr/Iran', 'Subjects were 1128 third and fourth graders, aged 9 to 10 years (49.1% boys and 50.9% girls', '14 elementary schools, categorized by socioeconomic types and male and female setting']",[],"['total healthy heart knowledge scores', 'cardiovascular health', 'heart healthy knowledge', 'Total heart knowledge']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",14.0,0.0362645,"RESULTS


Total heart knowledge at posttest was 25% correct higher in the intervention than in the control group (p< 0.001).","[{'ForeName': 'Iraj', 'Initials': 'I', 'LastName': 'Nabipour', 'Affiliation': 'Persian Gulf Health Research Center, Bushehr University of Medical Science, Bushehr, I.R, Iran. nabipour@bpums.ac.ir'}, {'ForeName': 'Syed Reza', 'Initials': 'SR', 'LastName': 'Imami', 'Affiliation': ''}, {'ForeName': 'Mohammad Mehdi', 'Initials': 'MM', 'LastName': 'Mohammadi', 'Affiliation': ''}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Heidari', 'Affiliation': ''}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Bahramian', 'Affiliation': ''}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Azizi', 'Affiliation': ''}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Khosravizadegan', 'Affiliation': ''}, {'ForeName': 'Raha', 'Initials': 'R', 'LastName': 'Pazoki', 'Affiliation': ''}, {'ForeName': 'Ali-Reza', 'Initials': 'AR', 'LastName': 'Soltanian', 'Affiliation': ''}, {'ForeName': 'Mahbobeh', 'Initials': 'M', 'LastName': 'Ramazanzadeh', 'Affiliation': ''}, {'ForeName': 'Abdolresoul', 'Initials': 'A', 'LastName': 'Emadi', 'Affiliation': ''}, {'ForeName': 'Jahfar', 'Initials': 'J', 'LastName': 'Arab', 'Affiliation': ''}, {'ForeName': 'Bagher', 'Initials': 'B', 'LastName': 'Larijani', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1778,31220872,Social norm feedback reduces primary care antibiotic prescribing in a regression discontinuity study.,"BACKGROUND


Reducing antibiotic prescribing is a priority for health authorities responsible for preventing antimicrobial resistance. Northern Ireland has high rates of antimicrobial use. We implemented a social norm feedback intervention and evaluated its impact.
OBJECTIVES


To estimate the size and duration of the effect of a social norm feedback letter to GPs who worked in the 20% of practices with the highest antimicrobial prescribing.
METHODS


The letter was sent in October 2017 to 221 GPs in 67 practices. To assess the effect of the intervention, we used a sharp non-parametric regression discontinuity (RD) design, with prescribing rates in the four calendar quarters following the intervention as the outcome variables.
RESULTS


In the quarter following the intervention (October to December 2017) there was a change of -25.7 (95% CI = -42.5 to -8.8, P = 0.0028) antibiotic items per 1000 Specific Therapeutic group Age-sex Related Prescribing Units (STAR-PU). At 1 year, the coefficient was -58.7 (95% CI = -116.7 to -0.7, P = 0.047) antibiotic items per 1000 STAR-PU. The greatest change occurred soon after the intervention. Approximately 18900 fewer antibiotic items were prescribed than if the intervention had not been made (1% of Northern Ireland's annual primary care antibiotic prescribing).
CONCLUSIONS


A social norm feedback intervention reduced antibiotic prescribing in the intervention practices. The diminishing effect over time suggests the need for more frequent feedback. The RD method allowed measurement of the effectiveness of an intervention that was delivered as part of normal business, without a randomized trial.",2019,"At 1 year, the coefficient was -58.7 (95% CI = -116.7 to -0.7, P = 0.047) antibiotic items per 1000 STAR-PU.",[],['Social norm feedback'],[],[],"[{'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",[],,0.0467292,"At 1 year, the coefficient was -58.7 (95% CI = -116.7 to -0.7, P = 0.047) antibiotic items per 1000 STAR-PU.","[{'ForeName': 'Declan T', 'Initials': 'DT', 'LastName': 'Bradley', 'Affiliation': ""Centre for Public Health, Institute of Clinical Sciences, Block A, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Royal Victoria Hospital, Grosvenor Road, Belfast, UK.""}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Allen', 'Affiliation': 'Public Sector Innovation Lab, Department of Finance, Clare House, 303 Airport Road, Belfast, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Quinn', 'Affiliation': 'Health and Social Care Board, 12-22 Linenhall Street, Belfast, UK.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Bradley', 'Affiliation': 'Health and Social Care Board, 12-22 Linenhall Street, Belfast, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Dolan', 'Affiliation': 'Health and Social Care Board, 12-22 Linenhall Street, Belfast, UK.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz222']
1779,31494097,"Safety and efficacy of AMG 714 in patients with type 2 refractory coeliac disease: a phase 2a, randomised, double-blind, placebo-controlled, parallel-group study.","BACKGROUND


Refractory coeliac disease type 2 is a rare subtype of coeliac disease with high mortality rates; interleukin 15 (IL-15) is strongly implicated in its pathophysiology. This trial aimed to investigate the effects of AMG 714, an anti-IL-15 monoclonal antibody, on the activity and symptoms of refractory coeliac disease type 2.
METHODS


This was a randomised, double-blind, placebo-controlled, phase 2a study of adults with a confirmed diagnosis of refractory coeliac disease type 2. Patients were randomly assigned at a 2:1 ratio to receive seven intravenous doses over 10 weeks of AMG 714 (8 mg/kg) or matching placebo. Biopsy samples were obtained at baseline and week 12 for cellular analysis and histology. The change in the proportion of aberrant intraepithelial lymphocytes from baseline to week 12 with respect to all intraepithelial lymphocytes was the primary endpoint and was quantified using flow cytometry. Secondary endpoints were the change in aberrant intraepithelial lymphocytes with respect to intestinal epithelial cells; intestinal histological scores (villous height-to-crypt depth ratio; VHCD); intraepithelial lymphocyte counts; Marsh score; and patient-reported symptom measures, including the Bristol stool form scale (BSFS) and gastrointestinal symptom rating scale (GSRS). Main analyses were done in the per-protocol population of patients who received their assigned treatment, provided evaluable biopsy samples, and did not have major protocol deviations; only patients with non-atypical disease were included in the analyses of aberrant intraepithelial lymphocytes, including the primary analysis. Safety was assessed in all patients who received at least one dose of study drug. This study is registered at ClinicalTrials.gov (NCT02633020) and EudraCT (2015-004063-36).
FINDINGS


From April 13, 2016, to Jan 19, 2017, 28 patients were enrolled and randomly assigned to AMG 714 (n=19) and placebo (n=9). Six patients were not included in the primary analysis because of protocol deviation (one in the AMG 714 group), insufficient biopsy samples (one in the AMG 714 group), and atypical intraepithelial lymphocytes (three in the AMG 714 group and one in the placebo group). At 12 weeks, the least square mean difference between AMG 714 and placebo in the relative change from baseline in aberrant intraepithelial lymphocyte percentage was -4·85% (90% CI -30·26 to 20·56; p=0·75). The difference between the AMG 714 and placebo groups in aberrant intraepithelial lymphocytes with respect to epithelial cells at 12 weeks was -38·22% (90% CI -95·73 to 19·29; nominal p=0·18); the difference in change in Marsh score from baseline was 0·09% (95% CI -1·60-1·90; nominal p=0·92); the difference in VHCD ratio was 10·67% (95% CI -38·97 to 60·31; nominal p=0·66); and the difference in change in total intraepithelial lymphocyte count was -12·73% (95% CI -77·57-52·12); nominal p=0·69). Regarding symptoms, the proportion of patients with diarrhoea per the BSFS score decreased from ten (53%) of 19 at baseline to seven (37%) of 19 at week 12 in the AMG 714 group and increased from two (22%) of nine at baseline to four (44%) of nine at week 12 in the placebo group (nominal p=0·0008); and the difference between the groups in change in GSRS score was -0·14 (SE 0·19; nominal p=0·48). Eight (89%) patients in the placebo group and 17 (89%) in the AMG 714 group had treatment-emergent adverse events, including one (11%) patient in the placebo group and five (26%) in the AMG 714 group who had serious adverse events. The most common adverse event in the AMG 714 group was nasopharyngitis (eight [42%] patients vs one [11%] in the placebo group).
INTERPRETATION


In patients with refractory coeliac disease type 2 who were treated with AMG 714 or placebo for 10 weeks, there was no difference between the groups in terms of the primary endpoint of aberrant intraepithelial lymphocyte reduction from baseline. Effects on symptoms and other endpoints suggest that further research of AMG 714 may be warranted in patients with refractory coeliac disease type 2.
FUNDING


Celimmune and Amgen.",2019,The change in the proportion of aberrant intraepithelial lymphocytes from baseline to week 12 with respect to all intraepithelial lymphocytes was the primary endpoint and was quantified using flow cytometry.,"['adults with a confirmed diagnosis of refractory coeliac disease type 2', 'patients with refractory coeliac disease type 2 who were treated with', 'patients with type 2 refractory coeliac disease', 'patients with refractory coeliac disease type 2', 'Six patients were not included in the primary analysis because of protocol deviation (one in the AMG 714 group), insufficient biopsy samples (one in the AMG 714 group), and atypical intraepithelial lymphocytes (three in the AMG 714 group and one in the placebo group', 'From April 13, 2016, to Jan 19, 2017, 28 patients']","['AMG 714 (8 mg/kg) or matching placebo', 'AMG', 'placebo', 'EudraCT', 'AMG 714 or placebo']","['BSFS score', 'GSRS score', 'Safety', 'VHCD ratio', 'Safety and efficacy', 'proportion of aberrant intraepithelial lymphocytes', 'aberrant intraepithelial lymphocytes with respect to epithelial cells', 'nasopharyngitis', 'treatment-emergent adverse events', 'change in aberrant intraepithelial lymphocytes with respect to intestinal epithelial cells; intestinal histological scores (villous height-to-crypt depth ratio; VHCD); intraepithelial lymphocyte counts; Marsh score; and patient-reported symptom measures, including the Bristol stool form scale (BSFS) and gastrointestinal symptom rating scale (GSRS', 'aberrant intraepithelial lymphocyte reduction', 'total intraepithelial lymphocyte count', 'aberrant intraepithelial lymphocyte percentage', 'serious adverse events', 'change in Marsh score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0007570', 'cui_str': 'Sprue, Nontropical'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0677862', 'cui_str': 'Biopsy sample (specimen)'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C1512944', 'cui_str': 'Intraepithelial T Cells'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0443127', 'cui_str': 'Aberrant (qualifier value)'}, {'cui': 'C1512944', 'cui_str': 'Intraepithelial T Cells'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0014597', 'cui_str': 'Epithelial Cells'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C1721089', 'cui_str': 'Marshes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1997606', 'cui_str': 'Bristol stool form scale'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0222045'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",714.0,0.631348,The change in the proportion of aberrant intraepithelial lymphocytes from baseline to week 12 with respect to all intraepithelial lymphocytes was the primary endpoint and was quantified using flow cytometry.,"[{'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Cellier', 'Affiliation': 'Department of Gastroenterology and Endoscopy, University Hospital Georges Pompidou, Assistance Publique Hôpitaux de Paris, Paris, France. Electronic address: christophe.cellier@aphp.fr.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Bouma', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, Vrije Universiteit Medical Centre, Amsterdam, Netherlands.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'van Gils', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, Vrije Universiteit Medical Centre, Amsterdam, Netherlands.'}, {'ForeName': 'Sherine', 'Initials': 'S', 'LastName': 'Khater', 'Affiliation': 'Department of Gastroenterology and Endoscopy, University Hospital Georges Pompidou, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Malamut', 'Affiliation': 'Department of Gastroenterology and Endoscopy, University Hospital Georges Pompidou, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Crespo', 'Affiliation': 'Department of Gastroenterology, University Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Collin', 'Affiliation': 'Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Peter H R', 'Initials': 'PHR', 'LastName': 'Green', 'Affiliation': 'Celiac Disease Center, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Sheila E', 'Initials': 'SE', 'LastName': 'Crowe', 'Affiliation': 'Department of Medicine, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Tsuji', 'Affiliation': 'Department of Medicine, University of California San Diego, Celimmune, Bethesda, MD, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Butz', 'Affiliation': 'Department of Medicine, University of California San Diego, Celimmune, Bethesda, MD, USA.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Cerf-Bensussan', 'Affiliation': 'Laboratory of Intestinal Immunity and Institut Imagine, Paris, France.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Macintyre', 'Affiliation': 'Haematology, Université Paris Descartes, Hôpital Necker, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Jane R', 'Initials': 'JR', 'LastName': 'Parnes', 'Affiliation': 'Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Leon', 'Affiliation': 'Department of Medicine, University of California San Diego, Celimmune, Bethesda, MD, USA; Provention Bio, Oldwick, NJ, USA.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Hermine', 'Affiliation': 'Haematology, Université Paris Descartes, Hôpital Necker, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': 'Mulder', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, Vrije Universiteit Medical Centre, Amsterdam, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30265-1']
1780,32103603,A pilot multi-centre prospective randomised controlled trial of RECELL for the treatment of venous leg ulcers.,"Venous leg ulcers (VLUs) have a significant impact on approximately 3% of the adult population worldwide, with a mean NHS wound care cost of £7600 per VLU over 12 months. The standard care for VLUs is compression therapy, with a significant number of ulcers failing to heal with this treatment, especially with wound size being a risk factor for non-healing. This multicentre, prospective, randomised trial evaluated the safety and effectiveness of autologous skin cell suspension (ASCS) combined with compression therapy compared with standard compression alone (Control) for the treatment of VLUs. Incidence of complete wound closure at 14 weeks, donor site closure, pain, Health-Related Quality of Life (HRQoL), satisfaction, and safety were assessed in 52 patients. At Week 14, VLUs treated with ASCS + compression had a statistically greater decrease in ulcer area compared with the Control (8.94 cm 2  versus 1.23 cm 2  , P = .0143). This finding was largely driven by ulcers >10 to 80 cm 2  in size, as these ulcers had a higher mean percentage of reepithelialization at 14 weeks (ASCS + compression: 69.97% and Control: 11.07%, P = .0480). Additionally, subjects treated with ASCS + compression experienced a decrease in pain and an increase in HRQoL compared with the Control. This study indicates that application of ASCS + compression accelerates healing in large venous ulcers.",2020,"Additionally, subjects treated with ASCS + compression experienced a decrease in pain and an increase in HRQoL compared with the Control.",['venous leg ulcers'],"['autologous skin cell suspension (ASCS) combined with compression therapy', 'ASCS\u2009+\u2009compression', 'standard compression alone (Control']","['HRQoL', 'ulcer area', 'Venous leg ulcers (VLUs', 'Incidence of complete wound closure at 14\u2009weeks, donor site closure, pain, Health-Related Quality of Life (HRQoL), satisfaction, and safety', 'pain']","[{'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0023223', 'cui_str': 'Leg Ulcer'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0814995', 'cui_str': 'Skin cell'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0023223', 'cui_str': 'Leg Ulcer'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1444716', 'cui_str': 'Donor site (attribute)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",52.0,0.0493844,"Additionally, subjects treated with ASCS + compression experienced a decrease in pain and an increase in HRQoL compared with the Control.","[{'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Hayes', 'Affiliation': ""St John's Innovation Centre, Cambridge, UK.""}, {'ForeName': 'Keith G', 'Initials': 'KG', 'LastName': 'Harding', 'Affiliation': 'Clinical Innovation Cardiff, Cardiff, Wales.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Johnson', 'Affiliation': 'Doncaster Royal Infirmary, Doncaster, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'McCollum', 'Affiliation': 'Wythenshawe Hospital, Manchester, UK.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Téot', 'Affiliation': 'Lapeyronie Health Facility, Montpellier, France.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Mercer', 'Affiliation': 'Bradford Royal Infirmary, Bradford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Russell', 'Affiliation': 'Leeds General Infirmary, Leeds, UK.'}]",International wound journal,['10.1111/iwj.13293']
1781,31882288,Temporal Summation in Chronic Pelvic Pain.,"OBJECTIVE


This study sought to characterize central sensitization further among women with chronic pelvic pain by identifying temporal summation using a cotton-tipped applicator test that can be used at the bedside.
METHOD


A total of 36 women (18 with chronic pain and allodynia; 18 without pain) were recruited. Both groups were randomly assigned to receive 3 strokes of a benign stimulus on the abdomen at differing frequencies: 10, 30, or 100 seconds. Each group included 6 women. Pain was assessed using a rating scale of 1 to 10. Data were analyzed using the multivariate approach to repeated measures analysis of variance.
RESULTS


The pattern of pain scores differed significantly between women with and without chronic pain (P = 0.002). Women with chronic pelvic pain and allodynia showed a statistically significant increase in pain with successive strokes of the cotton-tipped applicator (P = 0.012 for stroke 1 vs. 2, P = 0.026 for stroke 2 vs. 3, and P = 0.005 for stroke 1 vs. 3).
CONCLUSION


Women with chronic pelvic pain and allodynia showed significant worsening of pain with successive strokes of a cotton-tipped applicator. This finding indicates that pain wind-up and central sensitization are present in women with chronic pelvic pain and allodynia. Identification of summation is further evidence of neuroplasticity, which is helpful in innovative therapies for chronic pelvic pain.",2020,"Women with chronic pelvic pain and allodynia showed a statistically significant increase in pain with successive strokes of the Q-tip (P = 0.012 for stroke 1 vs. 2, P = 0.026 for stroke 2 vs. 3, and P = 0.005 for stroke 1 vs. 3).
","['chronic pelvic pain', 'women with chronic pelvic pain and allodynia', 'women with chronic pelvic pain', 'Chronic Pelvic Pain', '36 women (18 with chronic pain and allodynia; 18 without pain']",[],"['pain with successive strokes of the Q-tip', 'chronic pelvic pain and allodynia', 'Pain', 'pattern of pain scores']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0458247', 'cui_str': 'Allodynia'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0458247', 'cui_str': 'Allodynia'}, {'cui': 'C1286321', 'cui_str': 'Pattern of pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",36.0,0.0823387,"Women with chronic pelvic pain and allodynia showed a statistically significant increase in pain with successive strokes of the Q-tip (P = 0.012 for stroke 1 vs. 2, P = 0.026 for stroke 2 vs. 3, and P = 0.005 for stroke 1 vs. 3).
","[{'ForeName': 'Heather D', 'Initials': 'HD', 'LastName': 'Thompson', 'Affiliation': 'Department of Obstetrics and Gynecology, Cumming School of Medicine, University of Calgary, Calgary, AB.'}, {'ForeName': 'Selphee', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Department of Obstetrics and Gynecology, Cumming School of Medicine, University of Calgary, Calgary, AB.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Jarrell', 'Affiliation': 'Department of Obstetrics and Gynecology, Cumming School of Medicine, University of Calgary, Calgary, AB. Electronic address: john.jarrell@ahs.ca.'}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2019.09.012']
1782,31257435,"Effectiveness of an intervention to improve antibiotic-prescribing behaviour in primary care: a controlled, interrupted time-series study.","BACKGROUND


High rates of antibiotic misprescribing in primary care, with alarming clinical and economic consequences, highlight the urgent need for interventions to improve antibiotic prescribing in this setting.
OBJECTIVES


To assess the effectiveness on antibiotic prescribing quality indicators of a multifaceted intervention targeting health professionals' and patients' behaviour regarding antibiotic use.
METHODS


We conducted a pragmatic cluster-randomized controlled trial in the catchment area covered by Portugal's Central Regional Health Administration. The intervention consisted of a multidisciplinary, multifaceted programme involving physicians, pharmacists and patients, and comprising outreach visits for physicians and pharmacists, and educational materials for health professionals and patients. The following were assessed: relative ratios of prescription of penicillins sensitive to β-lactamase, penicillin combinations including β-lactamase inhibitors, third- and fourth-generation cephalosporins and fluoroquinolones; and the ratio of broad- to narrow-spectrum antibiotics. An interrupted time-series analysis for multiple-group comparisons was performed. The study protocol was registered on Clinical.trials.gov (NCT02173509).
RESULTS


The participation rate in the educational intervention was 64% (197/309 GPs) in a total of 25 counties. Statistically significant improvements were obtained, not only in the relative prescription of penicillins sensitive to β-lactamase (overall relative change of +896%) and penicillin combinations including β-lactamase inhibitors (-161%), but also in the ratio of broad- to narrow-spectrum antibiotics (-200%). Statistically significant results were also obtained for third- and fourth-generation cephalosporins, though only in the immediate term.
CONCLUSIONS


This study showed that quality indicators of antibiotic prescribing can be improved by tackling influences on behaviour including knowledge and attitudes surrounding physicians' clinical practice. Accordingly, these determinants must be considered when implementing interventions aimed at improving antibiotic prescribing.",2019,"Statistically significant results were also obtained for third- and fourth-generation cephalosporins, though only in the immediate term.
",['primary care'],"['multidisciplinary, multifaceted programme involving physicians, pharmacists and patients, and comprising outreach visits for physicians and pharmacists, and educational materials for health professionals and patients']","['participation rate', 'antibiotic-prescribing behaviour', 'relative ratios of prescription of penicillins sensitive to β-lactamase, penicillin combinations including β-lactamase inhibitors, third- and fourth-generation cephalosporins and fluoroquinolones; and the ratio of broad- to narrow-spectrum antibiotics']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0205291', 'cui_str': 'Multifaceted (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for (contextual qualifier) (qualifier value)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1264683', 'cui_str': 'Relative ratio'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0030842', 'cui_str': 'Antibiotics, Penicillin'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0361823', 'cui_str': 'Fourth generation cephalosporin (substance)'}, {'cui': 'C0949665', 'cui_str': 'Fluoroquinolones'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C3854333', 'cui_str': 'Narrowing'}]",,0.110527,"Statistically significant results were also obtained for third- and fourth-generation cephalosporins, though only in the immediate term.
","[{'ForeName': 'António', 'Initials': 'A', 'LastName': 'Teixeira Rodrigues', 'Affiliation': 'Institute of Biomedicine - iBiMED, Department of Medical Sciences, University of Aveiro, Aveiro, Portugal.'}, {'ForeName': 'Fátima', 'Initials': 'F', 'LastName': 'Roque', 'Affiliation': 'Institute of Biomedicine - iBiMED, Department of Medical Sciences, University of Aveiro, Aveiro, Portugal.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Piñeiro-Lamas', 'Affiliation': 'Consortium for Biomedical Research in Epidemiology and Public Health (CIBER Epidemiología y Salud Pública-CIBERESP), University of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Amílcar', 'Initials': 'A', 'LastName': 'Falcão', 'Affiliation': 'Faculty of Pharmacy, University of Coimbra (FFUC), Coimbra, Portugal.'}, {'ForeName': 'Adolfo', 'Initials': 'A', 'LastName': 'Figueiras', 'Affiliation': 'Consortium for Biomedical Research in Epidemiology and Public Health (CIBER Epidemiología y Salud Pública-CIBERESP), University of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Herdeiro', 'Affiliation': 'Institute of Biomedicine - iBiMED, Department of Medical Sciences, University of Aveiro, Aveiro, Portugal.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz244']
1783,15122049,Comparison of the immunogenicity and safety of two different brands of Salmonella typhi Vi capsular polysaccharide vaccine.,"BACKGROUND


The recent emergence of multi-drug-resistant Salmonella strains highlights the need for better preventive measures, including vaccination. Safe and immunologic vaccines have been developed based on purified Vi polysaccharide.
OBJECTIVE


To compare the immune response elicited by two different brands of Salmonella Vi capsular polysaccharide vaccine (ViCPS).
SETTING AND DESIGN


Double blind, randomized (3:1), controlled, parallel, phase III study was conducted at two centres in India to compare the safety and immunogenicity of Typbar, the investigational vaccine with an already marketed vaccine ""X"", in healthy subjects aged between 12 -25 years.
MATERIAL AND METHODS


A sample size of 184 subjects was calculated. Subjects were randomly distributed in two groups, immunized with single dose of Typbar or Vaccine ""X"". Serum samples were taken before 7 days and 4 weeks after immunization for the determination of antibodies to Vi polysaccharide, by ELISA method. Safety was assessed by physical examination, laboratory parameters before and after vaccination and by monitoring adverse events.
STATISTICS


The geometric mean antibody titre (GMT) 4 weeks after vaccination was compared from respective pre-vaccination values by Wilcoxon signed rank test. Geometric mean of antibody levels before and after immunization and the ratio between them (Mann-Whitney test), the Seroconversion rates (Z test of proportions) and the adverse events (Fisher's exact test and Chi square test), were compared between two groups. P value < 0.05 was considered statistically significant. P values and 95% confidence intervals were estimated in two-tailed fashion.
RESULTS


153 subjects (Typbar =116 and Vaccine ""X"" =37) were studied. 71.6% (95% CI=63.4%-79.8%) and 75.7% (95% CI=64.9% - 89.5%) were the seroconversion rates with Typbar and vaccine ""X"" respectively. The GMT values for Vi antibodies induced after Typbar and vaccine ""X"" were 10.23 Typbar and 13.46 mg/mL respectively and these values showed high significance when compared to their respective pre-immunization GMT values (P<0.0001) at 95% CI (-10.49 to -7.19 mg/mL for Typbar and -14.69 to -8.86 mg/mL for Vaccine ""X""). The induction of antibody response appeared to be slightly stronger (P=0.032) with vaccine ""X"" when compared to that of Typbar. This is justifiable as the same group also had high pre-immunization GMT values (P=0.021).
CONCLUSION


The immunogenicity and safety of the investigational vaccine Typbar was found to be similar to that of already marketed brand of Vi CPS, Vaccine ""X"". The availability of a single dose of vaccine that is safe and effective enhances the prospective for control of typhoid fever.",2004,"The induction of antibody response appeared to be slightly stronger (P=0.032) with vaccine ""X"" when compared to that of Typbar.","['153 subjects (Typbar =116 and Vaccine ""X"" =37) were studied', 'healthy subjects aged between 12 -25 years']","['Typbar, the investigational vaccine with an already marketed vaccine ""X', 'vaccine', 'Salmonella typhi Vi capsular polysaccharide vaccine', 'Typbar or Vaccine ""X', 'Salmonella Vi capsular polysaccharide vaccine (ViCPS']","['Geometric mean of antibody levels', 'geometric mean antibody titre (GMT', 'immunogenicity and safety', 'seroconversion rates', 'induction of antibody response', 'Seroconversion rates']","[{'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1318228', 'cui_str': 'Market (environment)'}, {'cui': 'C0036125', 'cui_str': 'Salmonella typhosa'}, {'cui': 'C0205151', 'cui_str': 'Capsular (qualifier value)'}, {'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C0036111', 'cui_str': 'Salmonella'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}]",184.0,0.166659,"The induction of antibody response appeared to be slightly stronger (P=0.032) with vaccine ""X"" when compared to that of Typbar.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sabitha', 'Affiliation': 'Department of Pharmacology, Kasturba Medical College, P.B. no. 53, Mangalore-575001, India. sabita_rao1@rediffmail.com'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Prabha Adhikari', 'Affiliation': ''}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Chowdary', 'Affiliation': ''}, {'ForeName': 'Malathi', 'Initials': 'M', 'LastName': 'Prabhu', 'Affiliation': ''}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Soofi', 'Affiliation': ''}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Shetty', 'Affiliation': ''}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Kamath', 'Affiliation': ''}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Lokaranjan', 'Affiliation': ''}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Bangera', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1784,31021036,Randomized trial of facilitated subcutaneous immunoglobulin in multifocal motor neuropathy.,"BACKGROUND AND PURPOSE


To optimize subcutaneous therapy with immunoglobulins, large volume infusion of immunoglobulin G facilitated by pretreatment with hyaluronidase (fSCIG) was compared to conventional infusion of multiple small dosages (cSCIG) in 20 patients with multifocal motor neuropathy.
METHODS


A randomized, non-inferiority and observer-blinded cross-over design was applied with a treatment period of 24 weeks for each therapy.
RESULTS


In 18 patients fSCIG was feasible, two patients leaving the study due to side-effects. The primary study variable, isometric strength, was unchanged, being 100.8% [95% confidence interval (CI) 94.8%-107.1%) in fSCIG and 105.9% (95% CI 99.8%-112.0%) in cSCIG. Secondary end-points of disability, functions, impairments and quality of life showed no differences between the two treatments. Mild and short-lasting generalized side-effects were similar in the two groups, whereas the relative frequency of localized side-effects at the injection site was increased after fSCIG [0.63 (95% CI 0.23-1.00) vs. 0.09 (95% CI 0.00-0.22), P = 0.005]. The preference of the patients favoured fSCIG for two out of five visual analogue scale scores as well as the total mean score of all preferences (P = 0.03).
CONCLUSIONS


Facilitated SCIG seems effective, feasible and safe. In addition, it is preferred by patients but is accompanied by a higher frequency of short-lasting localized side-effects.",2019,"The primary study variable, isometric strength, was unchanged, being 100.8% [95% confidence interval (CI) 94.8%-107.1%) in fSCIG and 105.9% (95% CI 99.8%-112.0%) in cSCIG.","['20 patients with multifocal motor neuropathy', 'multifocal motor neuropathy']","['immunoglobulin G facilitated by pretreatment with hyaluronidase (fSCIG', 'conventional infusion of multiple small dosages (cSCIG', 'facilitated subcutaneous immunoglobulin']","['isometric strength', 'effective, feasible and safe', 'Mild and short-lasting generalized side-effects', 'disability, functions, impairments and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0393847', 'cui_str': 'Motor neuropathy with multiple conduction block (disorder)'}]","[{'cui': 'C0202087', 'cui_str': 'Immunoglobulin G measurement (procedure)'}, {'cui': 'C0020197', 'cui_str': 'Hyaluronidase'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0034380'}]",20.0,0.118924,"The primary study variable, isometric strength, was unchanged, being 100.8% [95% confidence interval (CI) 94.8%-107.1%) in fSCIG and 105.9% (95% CI 99.8%-112.0%) in cSCIG.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Al-Zuhairy', 'Affiliation': 'Department of Neurology, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jakobsen', 'Affiliation': 'Department of Neurology, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Andersen', 'Affiliation': 'Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Sindrup', 'Affiliation': 'Department of Neurology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'L K', 'Initials': 'LK', 'LastName': 'Markvardsen', 'Affiliation': 'Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}]",European journal of neurology,['10.1111/ene.13978']
1785,14993717,Sublingual misoprostol before first trimester abortion: a comparative study using two dose regimens.,"UNLABELLED


Various methods have been described for preoperative cervical priming prior to vacuum aspiration (VA) in first trimester pregnancy termination, to facilitate cervical dilatation and shorten the abortion procedure. Recently misoprostol a prostaglandin E1 analogue has been shown to be effective in facilitating cervical dilatation prior to VA. Misoprostol offers several advantages over the other prostagland in analogues including stability at room temperature, ease of administration and minimal side effects.
OBJECTIVE


To determine the optimal dosage and dosing interval for the use of misoprostol administered sublingually for pre-abortion cervical dilatation.
SETTING & DESIGN


This was a prospective randomised study conducted at Comprehensive Rural Health Project, Ballabgarh the rural health centre under Centre for Community Medicine, AIIMS, New Delhi.
MATERIAL AND METHODS


One hundred and twenty pregnant women between 6-11 weeks of gestation opting for voluntary medical termination of pregnancy were (MTP) randomly allocated to either 200 microg or the 400 microg misoprostol group. Vacuum aspiration was performed either two or three hours after administration of sublingual misoprostol. Using Hegar's dilators, degree of cervical dilatation before vacuum aspiration was measured. Other parameters assessed included the amount of additional dilatation required, intra-operative blood loss and associated side effects.
STATISTICS


Statistical analysis was conducted using chisquare, the student's t and the Mann-Whitney U tests to examine the difference between the two groups.
RESULTS


In the 200 microg misoprostol group 33% achieved a dilatation of > or = 8 mm compared with 71% of women in the 400 microg misoprostol group. The odds ratio was 95.8 (95% CI 10.2-842.9) for 400 microg misoprostol for successful preoperative cervical dilatation of > or = 8 mm. The mean baseline cervical dilatation for 400 microg and 200 microg misoprostol was 8.2 mm and 6.0 mm respectively (P < 0.001). The use of 400 mg misoprostol with an evacuation interval of two hours appears to be the optimal dosage and evacuation interval. Increasing the time interval beyond two hours did not confer any additional advantage on the rate of successful cervical dilatation but was instead associated with an increased incidence of side effects such as preoperative vaginal bleeding, abdominal pain and shivering.
CONCLUSION


Our study has shown that Sublingual administration of 400 microg of misoprostol at least two hours before procedure is effective for preoperative cervical dilatation before vacuum aspiration in first trimester pregnancy termination. There is no additional advantages of increasing the dosing interval upto three hours.",2004,The odds ratio was 95.8 (95% CI 10.2-842.9) for 400 microg misoprostol for successful preoperative cervical dilatation of > or = 8 mm.,"['before first trimester abortion', 'One hundred and twenty pregnant women between 6-11 weeks of gestation opting for voluntary medical termination of pregnancy', 'at Comprehensive Rural Health Project, Ballabgarh the rural health centre under Centre for Community Medicine, AIIMS, New Delhi']","['Misoprostol', 'sublingual misoprostol', 'Sublingual misoprostol', 'misoprostol', 'Vacuum aspiration']","['rate of successful cervical dilatation', 'amount of additional dilatation required, intra-operative blood loss and associated side effects', 'preoperative vaginal bleeding, abdominal pain and shivering', 'mean baseline cervical dilatation']","[{'cui': 'C0032979', 'cui_str': 'Early Placental Phase'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C3146282', 'cui_str': 'Medical termination of pregnancy (procedure)'}, {'cui': 'C0035959'}, {'cui': 'C0035960', 'cui_str': 'Rural Health Center'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0009473', 'cui_str': 'Community Medicine'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0079103', 'cui_str': 'Cervical Dilatation'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C2979982', 'cui_str': 'Vaginal Bleeding'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",120.0,0.457558,The odds ratio was 95.8 (95% CI 10.2-842.9) for 400 microg misoprostol for successful preoperative cervical dilatation of > or = 8 mm.,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Vimala', 'Affiliation': 'Department of Obstetrics & Gynaecology, AIIMS, New Delhi, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1786,14646157,A randomized controlled comparison of minialpartomy and lapartomy in ectopic pregnancy cases.,"BACKGROUND


As ectopic pregnancy is associated with significant maternal mortality and morbidity it may be worthwhile to find alternative surgical method to traditional laparotomy.
AIMS


To compare the efficacy, safety and cost effectiveness of minilaparotomy surgery for ectopic pregnancy cases with standard laparotomy method.
SETTING AND DESIGN


A total of 60 patients of ectopic pregnancy were randomized for minilaparotomy and laparotomy (30 cases each) for three years from January. 1998 to March 2001 in a medical college hospital.
MATERIAL AND METHODS


Patients history, clinical examination, intraoperative, preoperative and postoperative data were recorded and compared in minilaparotomy and laparotomy groups.
STATISTICAL ANALYSIS USED


Chi-square and Fischer chi-square test is used using P value of less than 0.05 as level of significance.
RESULTS


Mean operative time was significantly less in minilaparotomy (38 minutes) than in laparotomy group (54 minutes). Postoperative complications were fever in 4(13.33%) and 6(20%) cases, paralytic ileus in 3(10%) and 8(26.66%) cases, urinary tract infection in 2(6.66%) and 3(10%) cases and wound infection in 1(3.33%) and 5(16.66%) cases respectively in the two groups and were significantly less in the minilaparotomy cases. Mean day of mobility, starting normal diet and discharge from the hospital were 10 hours and 24 hours, 1.5 days and 3.1 days and 3.4 days and 6.9 days respectively in the two groups and were significantly less in the minilaparotomy group than the laparotomy group.
CONCLUSIONS


Surgery by minilaparotomy technique in ectopic pregnancy cases appears to be a safe and feasible method and is superior to conventional laparotomy as there are minimum perioperative and postoperative complications and patients can be discharged early from the hospital without the need of expensive equipment.",2003,Mean operative time was significantly less in minilaparotomy (38 minutes) than in laparotomy group (54 minutes).,"['60 patients of ectopic pregnancy', 'ectopic pregnancy cases with standard laparotomy method', '1998 to March 2001 in a medical college hospital', 'ectopic pregnancy cases', 'Patients history, clinical examination, intraoperative, preoperative and postoperative data were recorded and compared in minilaparotomy and laparotomy groups']","['minilaparotomy surgery', 'minilaparotomy and laparotomy', 'minialpartomy and lapartomy']","['Mean operative time', 'Mean day of mobility, starting normal diet and discharge from the hospital', 'wound infection', 'Postoperative complications', 'urinary tract infection', 'paralytic ileus', 'efficacy, safety and cost effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032987', 'cui_str': 'Ectopic Pregnancy'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0026168', 'cui_str': 'Minilaparotomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0026168', 'cui_str': 'Minilaparotomy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0184625', 'cui_str': 'Regular diet'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0030446', 'cui_str': 'Paralytic Ileus'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0270928,Mean operative time was significantly less in minilaparotomy (38 minutes) than in laparotomy group (54 minutes).,"[{'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, Maulana Azad Medical College & Associated Lok Nayak Hospital, New Delhi-110002, India. jbsharma@id.eth.net'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Malhotra', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Arora', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1787,14701947,"Ciprofloxacin-tinidazole combination, fluconazole- azithromicin-secnidazole-kit and doxycycline- metronidazole combination therapy in syndromic management of pelvic inflammatory disease: a prospective randomized controlled trial.","BACKGROUND


Pelvic inflammatory disease is a common problem faced by the gynecologists in there out patient department.
AIM


The aim of the study was to evaluate the efficacy of three treatment combinations in the syndromic management of pelvic inflammatory disease in the out patient setting. SETTING DESIGN: In the medical college hospital patients presenting in gynecology out patient department were enrolled.
MATERIAL AND METHODS


One hundred and sixty five women with diagnosis of pelvic inflammatory disease were randomized into three equal groups getting ciprofloxacin (500 mg) and tinidazole (600 mg) combination twice daily for 7 days (Group 1), a kit containing fluconazole (150 mg), azithromycin (1 gm) and secnidazole (2 mg) as one time dose (Group 2) and Doxycycline 100mg twice daily and metronidazole 200 mg thrice daily for seven days (Group 3). Severity score was determined on first visit and after 1 week and 4 weeks when patients were called for follow up.
STATISTICAL ANALYSIS


Chisqare test, Krusker wallis test and Mann Whitney test.
RESULTS


There was significant reduction in severity score after 1 week of treatment, which was further reduced after 4 weeks in all the three groups. Cure rate was highest in-group 1 (96%) followed by group 2 (93.5) and group 3 (91.3%) but the difference was not statistically significant. Resolution of inflammatory mass was highest in group 1. The incidence of side effects was highest and compliance was lowest in the doxycycline -metronidazole group, but the difference was not statistically significant.
CONCLUSION


All the three treatment combinations were found to be equally effective in the syndromic management of pelvic inflammatory disease.",2003,"The incidence of side effects was highest and compliance was lowest in the doxycycline -metronidazole group, but the difference was not statistically significant.
","['pelvic inflammatory disease in the out patient setting', 'pelvic inflammatory disease', 'medical college hospital patients presenting in gynecology out patient department were enrolled', 'One hundred and sixty five women with diagnosis of pelvic inflammatory disease']","['azithromycin (1 gm) and secnidazole', 'fluconazole', 'doxycycline -metronidazole', 'ciprofloxacin', 'Doxycycline 100mg twice daily and metronidazole', 'Ciprofloxacin-tinidazole combination, fluconazole- azithromicin-secnidazole-kit and doxycycline- metronidazole combination therapy', 'tinidazole']","['Resolution of inflammatory mass', 'severity score', 'Cure rate', 'incidence of side effects', 'Severity score']","[{'cui': 'C0242172', 'cui_str': 'Pelvic Inflammatory Disease'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient (finding)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0074246', 'cui_str': 'secnidazole'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0040263', 'cui_str': 'Tinidazole'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",165.0,0.0333125,"The incidence of side effects was highest and compliance was lowest in the doxycycline -metronidazole group, but the difference was not statistically significant.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Malhotra', 'Affiliation': 'Department of Obstetrics & Gynaecology and Biostatistics, Maulana Azad Medical College & Associated Lok Nayak Hospital, New Delhi - 110 002, India.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Batra', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Arora', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1788,31494096,"Safety and efficacy of AMG 714 in adults with coeliac disease exposed to gluten challenge: a phase 2a, randomised, double-blind, placebo-controlled study.","BACKGROUND


Interleukin 15 (IL-15) is implicated in the pathophysiology of coeliac disease. AMG 714 is the first anti-IL-15 monoclonal antibody to be investigated for the treatment of coeliac disease. We aimed to investigate the effects of AMG 714 in patients with coeliac disease who underwent gluten challenge.
METHODS


This randomised, double-blind, placebo-controlled, parallel-group, phase 2a trial was done at three clinical sites in Finland. Inclusion criteria included age 18-80 years, a confirmed diagnosis of coeliac disease, and adherence to a gluten-free diet for at least 12 months before screening. Patients were randomly assigned (1:1:1) to 150 mg AMG 714, 300 mg AMG 714, or placebo using permuted blocks and stratified by study site and sex. Patients and study staff were masked to treatment assignment. Treatments were administered by two subcutaneous injections every 2 weeks for 10 weeks (total six doses). Patients without severe villous atrophy at baseline received a gluten challenge (2-4 g daily) during weeks 2-12. Small bowel biopsy samples were obtained for histological assessments at baseline and week 12. The primary efficacy endpoint was the percentage change from baseline to week 12 in villous height-to-crypt depth (VHCD) ratio. Secondary endpoints were CD3-positive intraepithelial lymphocyte density; clinical symptoms measured by gastrointestinal symptom rating scale (GSRS), coeliac disease GSRS, and Bristol stool form scale (BSFS); and changes in anti-tTG and anti-DGP antibodies from baseline. The primary analysis was done in the per-protocol 1 population of patients who received at least one dose of study drug and who underwent the gluten challenge. Safety analyses were done in all patients who received at least one dose of study drug. This trial is registered at ClinicalTrials.gov, NCT02637141 and EudraCT, 2015-003647-19.
FINDINGS


Between April 13, 2016, and Nov 22, 2016, 64 patients were enrolled and randomly assigned to either the 150 mg AMG 714 group (n=22), the 300 mg AMG 714 group (n=22), or the placebo group (n=20). Two patients did not start treatment and two did not provide post-treatment biopsy samples. 49 patients underwent the gluten challenge (per-protocol 1 population) and 11 patients did not because of baseline villous atrophy. AMG 714 did not prevent mucosal injury due to gluten challenge. The least square mean difference in the relative change from baseline in VHCD ratio was -2·49% (95% CI -16·82 to 11·83; p=0·73) between 150 mg AMG 714 and placebo and 6·39% (-7·07 to 19·85; p=0·34) between 300 mg AMG 714 and placebo. Neither comparison was statistically significant. The density of CD3-positive intraepithelial lymphocytes increased in all groups, with smaller increases in the 300 mg group (-41·24% [95% CI -79·28 to -3·20] vs placebo, nominal p=0·03) but not the 150 mg group (-14·32% [-54·39 to 25·74], nominal p=0·47). Clinical symptoms were ameliorated with AMG 714 treatment between baseline and week 12, particularly diarrhoea as measured by the BSFS (nominal p=0·01 for 150 mg vs placebo, and nominal p=0·0002 for 300 mg vs placebo). Serum antibody titres for anti-tTG and anti-DGP antibodies increased in all three treatment groups, with no significant difference between AMG 714 and placebo. Treatment-emergent adverse events occurred in 21 (95%) patients in the 150 mg AMG 714 group, 0 (95%) in the 300 mg AMG 714 group, and 19 (100%) in the placebo group. The most common treatment-emergent adverse events were gastrointestinal disorders (17 [77%] participants in the 150 mg AMG 714 group, 16 [76%] in the 300 mg AMG 714 group, and 13 [68%] in the placebo group). Injection site reactions were the most common individual adverse event, reported in eight (36%) patients in the 150 mg AMG 714 group, 11 (52%) in the 300 mg group, and five (26%) in the placebo group. No serious adverse events occurred.
INTERPRETATION


The primary endpoint, change in VHCD ratio from baseline after 12 weeks of treatment in patients with coeliac disease undergoing gluten challenge, was not significantly different between placebo and AMG 714 at either 150 mg or 300 mg. Effects on intraepithelial lymphocyte density and symptoms suggest that further research of AMG 714 may be warranted in patients with non-responsive coeliac disease.
FUNDING


Celimmune and Amgen.",2019,"The density of CD3-positive intraepithelial lymphocytes increased in all groups, with smaller increases in the 300 mg group (-41·24% [95% CI -79·28 to -3·20] vs placebo, nominal p=0·03) but not the 150 mg group (-14·32% [-54·39 to 25·74], nominal p=0·47).","['Inclusion criteria included age 18-80 years, a confirmed diagnosis of coeliac disease, and adherence to a gluten-free diet for at least 12 months before screening', 'patients with non-responsive coeliac disease', 'Between April 13, 2016, and Nov 22, 2016, 64 patients', 'adults with coeliac disease exposed to gluten challenge', '49 patients underwent the gluten challenge (per-protocol 1 population) and 11 patients did not because of baseline villous atrophy', 'patients with coeliac disease who underwent gluten challenge']","['placebo', 'AMG', 'AMG 714, 300 mg AMG 714, or placebo']","['Small bowel biopsy samples', 'adverse events', 'VHCD ratio', 'diarrhoea', 'percentage change from baseline to week 12 in villous height-to-crypt depth (VHCD) ratio', 'severe villous atrophy', 'Safety and efficacy', 'CD3-positive intraepithelial lymphocyte density; clinical symptoms measured by gastrointestinal symptom rating scale (GSRS), coeliac disease GSRS, and Bristol stool form scale (BSFS); and changes in anti-tTG and anti-DGP antibodies', 'Serum antibody titres for anti-tTG and anti-DGP antibodies', 'change in VHCD ratio', 'Clinical symptoms', 'density of CD3-positive intraepithelial lymphocytes', 'gastrointestinal disorders']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0007570', 'cui_str': 'Sprue, Nontropical'}, {'cui': 'C0344351', 'cui_str': 'Gluten-Free Diet'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0554101', 'cui_str': 'Villous atrophy (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C0677862', 'cui_str': 'Biopsy sample (specimen)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0554101', 'cui_str': 'Villous atrophy (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1512944', 'cui_str': 'Intraepithelial T Cells'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0222045'}, {'cui': 'C0007570', 'cui_str': 'Sprue, Nontropical'}, {'cui': 'C1997606', 'cui_str': 'Bristol stool form scale'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}]",714.0,0.486434,"The density of CD3-positive intraepithelial lymphocytes increased in all groups, with smaller increases in the 300 mg group (-41·24% [95% CI -79·28 to -3·20] vs placebo, nominal p=0·03) but not the 150 mg group (-14·32% [-54·39 to 25·74], nominal p=0·47).","[{'ForeName': 'Marja-Leena', 'Initials': 'ML', 'LastName': 'Lähdeaho', 'Affiliation': 'Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Scheinin', 'Affiliation': 'Clinical Research Services Turku, Turku, Finland; Institute of Biomedicine, University of Turku, Turku, Finland.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Vuotikka', 'Affiliation': 'Institute of Biomedicine, University of Turku, Terveystalo, Oulu, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Taavela', 'Affiliation': 'Tampere University Hospital, Tampere, Finland; Faculty of Medicine and Health Technologies, Tampere University, Tampere, Finland; Department of Internal Medicine, Central Finland Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Popp', 'Affiliation': 'Tampere University Hospital, Tampere, Finland; Faculty of Medicine and Health Technologies, Tampere University, Tampere, Finland; University of Medicine and Pharmacy ""Carol Davila"", Bucharest, Romania.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Laukkarinen', 'Affiliation': 'Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Koffert', 'Affiliation': 'Department of Gastroenterology, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Olli-Pekka', 'Initials': 'OP', 'LastName': 'Koivurova', 'Affiliation': 'Institute of Biomedicine, University of Turku, Terveystalo, Oulu, Finland.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Pesu', 'Affiliation': 'Tampere University Hospital, Tampere, Finland; Faculty of Medicine and Health Technologies, Tampere University, Tampere, Finland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Kivelä', 'Affiliation': 'Tampere Center for Child Health Research, Tampere University and University Hospital, Tampere, Finland.'}, {'ForeName': 'Zsófia', 'Initials': 'Z', 'LastName': 'Lovró', 'Affiliation': 'Clinical Research Services Turku, Turku, Finland.'}, {'ForeName': 'Joni', 'Initials': 'J', 'LastName': 'Keisala', 'Affiliation': 'Institute of Biomedicine, University of Turku, Terveystalo, Oulu, Finland.'}, {'ForeName': 'Jorma', 'Initials': 'J', 'LastName': 'Isola', 'Affiliation': 'Tampere University Hospital, Tampere, Finland; Faculty of Medicine and Health Technologies, Tampere University, Tampere, Finland; Tampere Center for Child Health Research, Tampere University and University Hospital, Jilab, Tampere, Finland.'}, {'ForeName': 'Jane R', 'Initials': 'JR', 'LastName': 'Parnes', 'Affiliation': 'Tampere Center for Child Health Research, Tampere University and University Hospital, Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Leon', 'Affiliation': 'Tampere Center for Child Health Research, Tampere University and University Hospital, Celimmune, Bethesda, MD, USA; Tampere Center for Child Health Research, Tampere University and University Hospital, Provention Bio, Oldwick, NJ, USA. Electronic address: fleon@proventionbio.com.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Mäki', 'Affiliation': 'Tampere University Hospital, Tampere, Finland; Faculty of Medicine and Health Technologies, Tampere University, Tampere, Finland.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30264-X']
1789,14117945,"POLIOVIRUS VACCINE, LIVE, ORAL (SABIN). FIRST FIELD TRIAL IN INDIA. II. RESULTS OF LABORATORY TESTS.",,1964,,[],[],[],[],[],[],,0.0507007,,"[{'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'DAVE', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'KAUR', 'Affiliation': ''}, {'ForeName': 'P V', 'Initials': 'PV', 'LastName': 'GHARPURE', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1790,14069729,A CONTROLLED CLINICAL TRIAL OF GUANETHIDINE IN TOXEMIA OF PREGNANCY.,,1963,,[],[],[],[],[],[],,0.0341806,,"[{'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'DAFTARY', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'DESASOUZA', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'KUMAR', 'Affiliation': ''}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'MANDREKAR', 'Affiliation': ''}, {'ForeName': 'K D', 'Initials': 'KD', 'LastName': 'LOTLIKAR', 'Affiliation': ''}, {'ForeName': 'U K', 'Initials': 'UK', 'LastName': 'SHETH', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1791,13898175,"Poliovirus vaccine, live, oral (Sabin). First field trial in India. I. Administration of the vaccine.",,1962,,[],"['Poliovirus vaccine, live, oral (Sabin', 'vaccine']",[],[],"[{'cui': 'C0032374', 'cui_str': 'Poliovirus Vaccines'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]",[],,0.106667,,"[{'ForeName': 'P V', 'Initials': 'PV', 'LastName': 'GHARPURE', 'Affiliation': ''}, {'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'DAVE', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1792,31831920,Randomized controlled trial of topical mupirocin versus mupirocin with sucralfate combination in chronic skin ulcers.,"OBJECTIVES


The objective of this study was to carry out a head-to-head comparison of topical sucralfate combined with mupirocin versus mupirocin alone in the treatment of chronic skin ulcers with respect to both effectiveness and safety.
MATERIALS AND METHODS


A parallel-group, open-label, randomized, controlled trial (CTRI/2015/12/006443) was carried out with patients suffering from skin ulcers of Wagner grading 1 or 2 persisting for over 4 weeks. Ninety-six patients were recruited in total, and the modified intention-to-treat analysis dataset included 44 participants treated with mupirocin 2% and 46 treated with combined mupirocin 2% and sucralfate 7% ointment. Both medications were applied topically thrice daily for 6 weeks. Ulcer area assessed using millimeter graph paper and wound infection score assessed on a three-point scale were effectiveness measures. Treatment-emergent adverse reactions that were reported by patients or observed by the investigators were recorded.
RESULTS


The median ulcer area was significantly reduced in the combined treatment group at the end of treatment. Clinically, 41.3% of the participants in the combined group showed complete ulcer healing at 6 weeks compared to 18.18% in the mupirocin alone group ( P  = 0.022). The wound infection score declined significantly from baseline by the end of 3 weeks of treatment in both the groups. The frequency of qualitative wound attributes, namely pain, discharge, and erythema, remained comparable between the groups except for discharge which disappeared completely from all remaining ulcers in the combined group but was still present in 11.36% of the participants treated with mupirocin alone ( P  = 0.025) at 6 weeks. Adverse events were few, all local, mild, and tolerable.
CONCLUSIONS


The wound healing effect of topical sucralfate adds to the antimicrobial effect of mupirocin toward the overall improvement of chronic skin ulcers. The effect of combined topical treatment needs comparison with other topical medications and wound healing strategies.",2019,"The frequency of qualitative wound attributes, namely pain, discharge, and erythema, remained comparable between the groups except for discharge which disappeared completely from all remaining ulcers in the combined group but was still present in 11.36% of the participants treated with mupirocin alone ( P  = 0.025) at 6 weeks.","['chronic skin ulcers', 'Ninety-six patients were recruited in total, and the modified intention-to-treat analysis dataset included 44 participants treated with mupirocin 2% and 46 treated with', 'patients suffering from skin ulcers of Wagner grading 1 or 2 persisting for over 4 weeks']","['topical sucralfate', 'topical sucralfate combined with mupirocin versus mupirocin alone', 'topical mupirocin versus mupirocin with sucralfate combination', 'combined mupirocin 2% and sucralfate 7% ointment']","['Adverse events', 'frequency of qualitative wound attributes, namely pain, discharge, and erythema', 'Ulcer area assessed using millimeter graph paper and wound infection score', 'effectiveness and safety', 'complete ulcer healing', 'median ulcer area', 'wound infection score']","[{'cui': 'C0157738', 'cui_str': 'Chronic ulcer of skin (disorder)'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0085259', 'cui_str': 'Mupirocin'}, {'cui': 'C0037299', 'cui_str': 'Skin Ulcer'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0038633', 'cui_str': 'Sucralfate'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0085259', 'cui_str': 'Mupirocin'}, {'cui': 'C0028912', 'cui_str': 'Salves'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0449234', 'cui_str': 'Attribute (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439200', 'cui_str': 'mm'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",44.0,0.0901271,"The frequency of qualitative wound attributes, namely pain, discharge, and erythema, remained comparable between the groups except for discharge which disappeared completely from all remaining ulcers in the combined group but was still present in 11.36% of the participants treated with mupirocin alone ( P  = 0.025) at 6 weeks.","[{'ForeName': 'Subhrangsu', 'Initials': 'S', 'LastName': 'Chatterjee', 'Affiliation': 'Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Department of Dermatology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India.'}, {'ForeName': 'Avijit', 'Initials': 'A', 'LastName': 'Hazra', 'Affiliation': 'Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India.'}, {'ForeName': 'Amal Kanti', 'Initials': 'AK', 'LastName': 'Das', 'Affiliation': 'Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India.'}]",Indian journal of pharmacology,['10.4103/ijp.IJP_237_17']
1793,31374208,Pre-EDIT: A Randomized Feasibility Trial of Elastance-Directed Intrapleural Catheter or Talc Pleurodesis in Malignant Pleural Effusion.,"BACKGROUND


Talc slurry pleurodesis (TSP) prevents recurrence of symptomatic malignant pleural effusion (MPE) in 71% to 78% patients. Nonexpansile lung (NEL) frequently accounts for TSP failure but is often occult predrainage, impairing selection of patients. NEL is associated with high pleural elastance (P EL ), but technical limitations have hampered the development of P EL  as a predictive NEL marker. We performed a single-center, randomized, controlled, open-label feasibility trial of EDIT (elastance-directed indwelling pleural catheter or TSP) management, using a novel digital manometer and a new definition of high P EL .
METHODS


Patients with symptomatic MPE were randomized 1:1 between EDIT and standard care (TSP). EDIT involved P EL  assessment during large-volume thoracentesis; patients with high P EL  (maximum P EL  sustained over 250 mL [MaxP EL250 ] ≥ 14.5 cm H 2 O/L) were allocated to immediately receive an indwelling pleural catheter; the remainder underwent immediate drain placement for TSP. The primary outcome measure was recruitment feasibility, defined a priori as 30 patients over 12 months. Secondary outcomes included safety, technical reliability, and the aspiration volume required to detect high P EL . The accuracy of the P EL  definition for NEL was analyzed post hoc.
RESULTS


Thirty-one patients were randomized (one allocation failure) over 12 months. P EL  assessment (mean duration, 33 minutes) was successful in 13 of 15 patients (87%). No directly attributable serious adverse events occurred. High P EL  was detected in seven of 13 patients (54%), associated with 100% sensitivity and 67% specificity for NEL, and was first detected at a median volume of 325 mL (range, 250-800 mL).
CONCLUSIONS


A phase 3 trial testing the effect of EDIT management on symptomatic MPE recurrence following TSP is feasible.
TRIAL REGISTRY


ClinicalTrials.gov; No.: NCT03319186; URL: www.clinicaltrials.gov.",2019,"High P EL  was detected in 7/13 patients (54%), associated with 100% sensitivity and 67% specificity for NEL, and was first detected at a median volume of 325ml (range 250ml-800ml).
","['Patients with symptomatic MPE', '31 patients', 'Malignant Pleural Effusion']","['EDIT (Elastance-directed indwelling pleural catheter (IPC) or TSP', 'Talc Slurry Pleurodesis (TSP', 'Elastance-Directed Intrapleural catheter or Talc Pleurodesis (EDIT', 'Pre-EDIT', 'immediate drain placement for TSP', 'TSP', 'NEL', 'EDIT and Standard Care (TSP', 'EDIT management']","['recurrence of symptomatic Malignant Pleural Effusion (MPE', 'High P EL', 'symptomatic MPE recurrence', 'safety, technical reliability and the aspiration volume required to detect high P EL ']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0080032', 'cui_str': 'Pleural Effusion, Malignant'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0439848', 'cui_str': 'Indwelling (qualifier value)'}, {'cui': 'C1322293', 'cui_str': 'Pleural catheter (physical object)'}, {'cui': 'C1533179', 'cui_str': 'Tsp'}, {'cui': 'C0039267', 'cui_str': 'Talc'}, {'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0405997', 'cui_str': 'Talc pleurodesis (procedure)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C3495845', 'cui_str': 'Drain placement'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0080032', 'cui_str': 'Pleural Effusion, Malignant'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}]",31.0,0.194399,"High P EL  was detected in 7/13 patients (54%), associated with 100% sensitivity and 67% specificity for NEL, and was first detected at a median volume of 325ml (range 250ml-800ml).
","[{'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Martin', 'Affiliation': 'Pleural Disease Unit, Queen Elizabeth University Hospital, Glasgow, UK; Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Selina', 'Initials': 'S', 'LastName': 'Tsim', 'Affiliation': 'Pleural Disease Unit, Queen Elizabeth University Hospital, Glasgow, UK; Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Kidd', 'Affiliation': 'Pleural Disease Unit, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Foster', 'Affiliation': 'Glasgow Clinical Research Imaging Facility, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'McLoone', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Chalmers', 'Affiliation': 'Institute of Cancer Sciences, University of Glasgow, Glasgow, UK; Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Blyth', 'Affiliation': 'Pleural Disease Unit, Queen Elizabeth University Hospital, Glasgow, UK; Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK. Electronic address: kevin.blyth@glasgow.ac.uk.'}]",Chest,['10.1016/j.chest.2019.07.010']
1794,31888701,"Zwakala Ndoda: a cluster and individually randomized trial aimed at improving testing, linkage, and adherence to treatment for hard-to reach men in KwaZulu-Natal, South Africa.","BACKGROUND


Men in sub-Saharan Africa are less likely than women to get tested for HIV, less likely to present for treatment, less likely to be maintained in treatment, more likely to have detectable viral load, more likely to transmit HIV with unprotected intercourse, and more likely to progress to AIDS and die sooner from HIV. The ultimate objective of this research is to provide evidence-based strategies to improve HIV testing and treatment of HIV-infected men.
METHODS


This study is being conducted in the Greater Edendale Area and Vulindlela region in KwaZulu-Natal, South Africa. It is a two-stage design of a cluster-randomized trial and an individual randomized trial to test how structural and individual-level interventions address the demand-side factors that affect HIV testing and treatment for hard-to reach, high-risk men. It combines male-focused mobilization, community-based mobile HIV testing services, and a small incentive to determine if the strategies singly and in combination can result in more men diagnosed with HIV, and more men linked to and maintained in care with undetectable viral load.
DISCUSSION


A priority for sub-Sahara Africa is developing and evaluating novel and cost-effective strategies for identifying hard-to-reach groups such as men, linking them to HIV testing and care services, and maintaining them in care to the point of viral suppression. We propose a combination prevention intervention that addresses men's individual, interpersonal, and structural barriers to testing and care. This includes male-led mobilization to encourage uptake of testing and treatment, male-focused testing venues, male-only counselors, developing counseling models that are flexible and responsive to men, and strategies for adhering to clinic visits without missing work and navigating the healthcare system. By thoughtfully combining male-focused mobilization, and testing and addressing some of the barriers to male engagement with health facilities, this study hopes to add to the growing evidence base about how to reach, test, link, and maintain a hard-to-reach group such as men in HIV treatment and care services.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03794245. Registered on 4 January 2019.",2019,"By thoughtfully combining male-focused mobilization, and testing and addressing some of the barriers to male engagement with health facilities, this study hopes to add to the growing evidence base about how to reach, test, link, and maintain a hard-to-reach group such as men in HIV treatment and care services.
","['Greater Edendale Area and Vulindlela region in KwaZulu-Natal, South Africa', 'HIV-infected men', 'hard-to reach, high-risk men', 'hard-to reach men in KwaZulu-Natal, South Africa']",['combination prevention intervention'],[],"[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0454729', 'cui_str': 'Natal (geographic location)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]",[],,0.0595357,"By thoughtfully combining male-focused mobilization, and testing and addressing some of the barriers to male engagement with health facilities, this study hopes to add to the growing evidence base about how to reach, test, link, and maintain a hard-to-reach group such as men in HIV treatment and care services.
","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'van Rooyen', 'Affiliation': 'Human Sciences Research Council, Durban, South Africa.'}, {'ForeName': 'Tawanda', 'Initials': 'T', 'LastName': 'Makusha', 'Affiliation': 'Human Sciences Research Council, Durban, South Africa. tmakusha@hsrc.ac.za.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Joseph', 'Affiliation': 'Human Sciences Research Council, Durban, South Africa.'}, {'ForeName': 'Thulani', 'Initials': 'T', 'LastName': 'Ngubane', 'Affiliation': 'Human Sciences Research Council, Durban, South Africa.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kulich', 'Affiliation': 'Faculty of Mathematics and Physics, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sweat', 'Affiliation': 'The Medical University of South Carolina, Charleston, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Coates', 'Affiliation': 'University of California Global Health Institute, San Francisco, USA.'}]",Trials,['10.1186/s13063-019-3908-0']
1795,31886216,The Efficacy of Cognitive Training for Elderly Chinese Individuals with Mild Cognitive Impairment.,"The age of the population is shifting toward the elderly range, which may lead to an increased risk of mild cognitive impairment (MCI). The aims of this study are to evaluate the cognitive function in elderly people using the Montreal Cognitive Assessment (MoCA), to identify the relationship between cognitive function and different characteristics, and to evaluate the efficacy of the intervention after six months of cognitive training. In this study, we included 2886 subjects aged ≧60 years in the baseline survey, and 140 subjects with MCI who participated in the baseline survey were randomly divided into an intervention group ( N  = 70) and a control group ( N  = 70). The control group was not provided any intervention measures, and the intervention group was administered cognitive training. The education level, monthly income, sleep time, exercise time, reading times, and time spent engaging in community activities and performing housework were positively correlated with MoCA scores, but age was negatively correlated with MoCA scores. The total MoCA score of the intervention group increased from 19.77 ± 2.24 points to 21.09 ± 2.20 points after six months of cognitive training, but the score of the control group decreased from 20.41 ± 2.10 points to 19.17 ± 2.57 points. The two-way repeated-measures ANOVA revealed a very significant effect of the interaction between time and cognitive training on the total MoCA score. Seventeen participants in the intervention group improved to normal levels, and no participants progressed to dementia after six months of cognitive training. Thus, the efficacy of the intervention was statistically significant. Our study concludes that older age is associated with a cognitive decline. Factors that are more likely to protect against cognitive decline included a higher education level and monthly income, sufficient sleep time, regular physical exercise and reading, frequently engaging in community activities, and continuing to perform housework. Moreover, the cognitive training intervention is effective and may help to decrease the deterioration of cognitive function in patients with MCI, and the interaction between intervention time and cognitive training significantly improves cognitive function.",2019,"The total MoCA score of the intervention group increased from 19.77 ± 2.24 points to 21.09 ± 2.20 points after six months of cognitive training, but the score of the control group decreased from 20.41 ± 2.10 points to 19.17 ± 2.57 points.","['Elderly Chinese Individuals with Mild Cognitive Impairment', '2886 subjects aged ≧60 years in the baseline survey, and 140 subjects with MCI who participated in the baseline survey', 'elderly people using the']","['Cognitive Training', 'Montreal Cognitive Assessment (MoCA', 'cognitive training', 'cognitive training intervention']","['total MoCA score', 'cognitive function', 'deterioration of cognitive function', 'normal levels', 'education level, monthly income, sleep time, exercise time, reading times, and time spent engaging in community activities and performing housework']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C3496286'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439587', 'cui_str': 'Exercise time (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1571726', 'cui_str': 'Doing housework (observable entity)'}]",2886.0,0.0150528,"The total MoCA score of the intervention group increased from 19.77 ± 2.24 points to 21.09 ± 2.20 points after six months of cognitive training, but the score of the control group decreased from 20.41 ± 2.10 points to 19.17 ± 2.57 points.","[{'ForeName': 'Zhenren', 'Initials': 'Z', 'LastName': 'Peng', 'Affiliation': 'Department of Occupational and Environmental Health, School of Public Health, Guangxi Medical University, Nanning 530021, China.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Occupational and Environmental Health, School of Public Health, Guangxi Medical University, Nanning 530021, China.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Guangxi Medical University, Nanning 530021, China.'}, {'ForeName': 'Kaiyong', 'Initials': 'K', 'LastName': 'Huang', 'Affiliation': 'Department of Occupational and Environmental Health, School of Public Health, Guangxi Medical University, Nanning 530021, China.'}, {'ForeName': 'Yukun', 'Initials': 'Y', 'LastName': 'Zuo', 'Affiliation': 'Department of Occupational and Environmental Health, School of Public Health, Guangxi Medical University, Nanning 530021, China.'}, {'ForeName': 'Xiangmin', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Occupational and Environmental Health, School of Public Health, Guangxi Medical University, Nanning 530021, China.'}, {'ForeName': 'Abu S', 'Initials': 'AS', 'LastName': 'Abdullah', 'Affiliation': 'Global Health Research Center, Duke Kunshan University, Kunshan 215316, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Occupational and Environmental Health, School of Public Health, Guangxi Medical University, Nanning 530021, China.'}]",BioMed research international,['10.1155/2019/4347281']
1796,31446213,Patient-reported outcomes in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer receiving olaparib versus chemotherapy in the OlympiAD trial.,"BACKGROUND


The phase III OlympiAD study (NCT02000622) showed a statistically significant progression-free survival benefit with olaparib versus chemotherapy treatment of physician's choice (TPC) in patients with a germline BRCA mutation and human epidermal growth factor receptor 2-negative metastatic breast cancer. From this study, we report the effect of olaparib on health-related quality of life (HRQoL).
METHODS


Patients were randomised 2:1 to olaparib monotherapy (300 mg twice daily) or single-agent TPC. The primary HRQoL end-point was mean change from baseline in the two-item global health status/QoL score determined from patient-completed European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item module (EORTC QLQ-C30) questionnaires and assessed using a mixed model for repeated measures. Symptoms and functioning domains, best overall response and time to deterioration of QoL were also evaluated.
RESULTS


Overall questionnaire compliance rates were 93.2% for olaparib and 76.3% for TPC. Between-treatment global health status/QoL comparison showed a significant improvement in the olaparib arm versus the TPC arm, with mean change of 3.9 (standard deviation 1.2) versus -3.6 (2.2), a difference of 7.5 points (95% confidence interval [CI]: 2.48, 12.44; P = 0.0035). A higher proportion of patients in the olaparib arm showed a best overall response of 'improvement' in global health status/QoL (33.7% vs 13.4%). Median time to global health status/QoL deterioration was not reached in olaparib patients and was 15.3 months for TPC patients (hazard ratio: 0.44 [95% CI: 0.25, 0.77]; P = 0.004). For EORTC QLQ-C30 symptoms and functioning subscales, only nausea/vomiting symptom score was worse in the olaparib arm than in the TPC arm (across all visits compared with baseline).
CONCLUSION


HRQoL was consistently improved for patients treated with olaparib, compared with chemotherapy TPC.",2019,"Between-treatment global health status/QoL comparison showed a significant improvement in the olaparib arm versus the TPC arm, with mean change of 3.9 (standard deviation 1.2) versus -3.6 (2.2), a difference of 7.5 points (95% confidence interval [CI]: 2.48, 12.44; P = 0.0035).","['Patients', 'patients with a germline BRCA mutation and human epidermal growth factor receptor 2-negative metastatic breast cancer', 'patients with a germline BRCA mutation and HER2-negative metastatic breast cancer receiving']","['olaparib versus chemotherapy', 'olaparib', 'single-agent TPC', 'TPC', 'olaparib monotherapy', 'chemotherapy TPC']","[""overall response of 'improvement' in global health status/QoL"", 'Median time to global health status/QoL deterioration', 'Cancer Quality of Life Questionnaire Core 30-item module (EORTC QLQ-C30) questionnaires', 'Overall questionnaire compliance rates', 'Symptoms and functioning domains, best overall response and time to deterioration of QoL', 'For EORTC QLQ-C30 symptoms and functioning subscales, only nausea/vomiting symptom score', 'HRQoL', 'global health status/QoL score', 'health-related quality of life (HRQoL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}]","[{'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042965', 'cui_str': 'Vomitus (substance)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",,0.169143,"Between-treatment global health status/QoL comparison showed a significant improvement in the olaparib arm versus the TPC arm, with mean change of 3.9 (standard deviation 1.2) versus -3.6 (2.2), a difference of 7.5 points (95% confidence interval [CI]: 2.48, 12.44; P = 0.0035).","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Robson', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: robsonm@mskcc.org.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Ruddy', 'Affiliation': 'Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN, USA.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Elżbieta', 'Initials': 'E', 'LastName': 'Senkus', 'Affiliation': 'Medical University of Gdańsk, Gdańsk, Poland.'}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Domchek', 'Affiliation': 'Basser Center, University of Pennsylvania, Philadelphia, PA, USA; Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': 'National Hospital Organization, Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Tung', 'Affiliation': 'Beth Israel Deaconess Medical Center, Dana-Farber Harvard Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Armstrong', 'Affiliation': 'Christie Hospital NHS Foundation Trust and Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Delaloge', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Bannister', 'Affiliation': 'AstraZeneca, Milton, Cambridge, UK.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Goessl', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Degboe', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hettle', 'Affiliation': 'AstraZeneca, Milton, Cambridge, UK.'}, {'ForeName': 'Pierfranco', 'Initials': 'P', 'LastName': 'Conte', 'Affiliation': 'University of Padova, Padova, Italy; Istituto Oncologico Veneto IRCCS, Padova, Italy.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.06.023']
1797,31437754,"Adverse events associated with encorafenib plus binimetinib in the COLUMBUS study: incidence, course and management.","BACKGROUND


Dual inhibition of the mitogen-activated protein kinase pathway with BRAF/MEK inhibitor (BRAFi/MEKi) therapy is a standard treatment for BRAFV600-mutant metastatic melanoma and has historically been associated with grade III pyrexia or photosensitivity depending on the combination used. The objective of this study was to fully describe adverse events from the COLUMBUS study evaluating the most recent BRAF/MEK inhibitor combination encorafenib+binimetinib.
PATIENTS AND METHODS


Patients with locally advanced, unresectable or metastatic BRAFV600-mutant melanoma were randomised to receive encorafenib 450 mg once daily plus binimetinib 45 mg twice daily, encorafenib 300 mg once daily or vemurafenib 960 mg twice daily. Adverse events that represent known effects of available BRAFi and/or MEKi were evaluated.
RESULTS


The safety population included a total of 570 patients (encorafenib+binimetinib = 192; encorafenib = 192; vemurafenib = 186). Median duration of exposure was longer with encorafenib+binimetinib (51 weeks) than with encorafenib (31 weeks) or vemurafenib (27 weeks). Common BRAFi/MEKi toxicities with encorafenib+binimetinib were generally manageable, reversible and infrequently associated with discontinuation. Pyrexia was less frequent with encorafenib+binimetinib (18%) and encorafenib (16%) than with vemurafenib (30%) and occurred later in the course of therapy with encorafenib+binimetinib (median time to first onset: 85 days versus 2.5 days and 19 days, respectively). The incidence of photosensitivity was lower with encorafenib+binimetinib (5%) and encorafenib (4%) than with vemurafenib (30%). The incidence of serous retinopathy was higher with encorafenib+binimetinib (20%) than with encorafenib (2%) or vemurafenib (2%), but no patients discontinued encorafenib+binimetinib because of this event.
CONCLUSION


Encorafenib+binimetinib is generally well tolerated and has a low discontinuation rate in patients with BRAFV600-mutant melanoma, with a distinct safety profile as compared with other anti-BRAF/MEK targeted therapies.
TRIAL REGISTRATION


ClinicalTrials.gov (Identifier: NCT01909453) and with EudraCT (number 2013-001176-38).",2019,The incidence of photosensitivity was lower with encorafenib+binimetinib (5%) and encorafenib (4%) than with vemurafenib (30%).,"['Patients with locally advanced, unresectable or metastatic BRAFV600-mutant melanoma', '570 patients (encorafenib+binimetinib\xa0=\xa0192; encorafenib\xa0=\xa0192; vemurafenib\xa0=\xa0186', 'patients with BRAFV600-mutant melanoma']","['encorafenib+binimetinib', 'encorafenib 450\xa0mg once daily plus binimetinib 45\xa0mg twice daily, encorafenib 300\xa0mg once daily\xa0or vemurafenib 960', 'Encorafenib+binimetinib', 'EudraCT', 'encorafenib', 'vemurafenib', 'BRAF/MEK inhibitor (BRAFi/MEKi) therapy']","['Pyrexia', 'incidence of serous retinopathy', 'incidence of photosensitivity', 'Median duration of exposure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C4079208', 'cui_str': 'encorafenib'}, {'cui': 'C3192263', 'cui_str': 'Vemurafenib'}]","[{'cui': 'C4079208', 'cui_str': 'encorafenib'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3899947', 'cui_str': 'Binimetinib'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3192263', 'cui_str': 'Vemurafenib'}, {'cui': 'C4517908', 'cui_str': '960 (qualifier value)'}, {'cui': 'C0752313', 'cui_str': 'MAPK-ERK Kinases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0440743', 'cui_str': 'Serous (qualifier value)'}, {'cui': 'C0035309', 'cui_str': 'Retinal Diseases'}, {'cui': 'C0349506', 'cui_str': 'Photosensitization'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",570.0,0.142337,The incidence of photosensitivity was lower with encorafenib+binimetinib (5%) and encorafenib (4%) than with vemurafenib (30%).,"[{'ForeName': 'Helen J', 'Initials': 'HJ', 'LastName': 'Gogas', 'Affiliation': 'Department of Internal Medicine, National and Kapodistrian University of Athens, Laikon Hospital, Athens, Greece. Electronic address: helgogas@gmail.com.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Flaherty', 'Affiliation': 'Cancer Center, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'Department of Dermatology, University Hospital Zürich Skin Cancer Center and University Zürich, Zürich, Switzerland.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Melanoma Unit, Cancer Immunotherapy and Innovative Therapies, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Arance', 'Affiliation': 'Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandala', 'Affiliation': 'Department of Oncology and Haematology, Papa Giovanni XXIII Cancer Center Hospital, Bergamo, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Liszkay', 'Affiliation': 'Department of Dermatology, National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Garbe', 'Affiliation': 'Department of Dermatology, University Hospital Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany, and German Cancer Consortium, Heidelberg, Germany.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Krajsova', 'Affiliation': 'Department of Dermato-oncology, University Hospital Prague and Charles University First Medical Faculty, Prague, Czech Republic.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Department of Dermatology and Allergy, Skin Cancer Center Hannover, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Vanna Chiarion', 'Initials': 'VC', 'LastName': 'Sileni', 'Affiliation': 'Melanoma Cancer Unit, Oncology Institute of Veneto IRCCS, Padua, Italy.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dutriaux', 'Affiliation': 'Department of Oncologic Dermatology, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux, France.'}, {'ForeName': 'Jan Willem B', 'Initials': 'JWB', 'LastName': 'de Groot', 'Affiliation': 'Department of Medical Oncology, Isala, Zwolle, Netherlands.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Dermatologic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Loquai', 'Affiliation': 'Department of Dermatology, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Gollerkeri', 'Affiliation': 'Array BioPharma Inc., Boulder, CO, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Pickard', 'Affiliation': 'Array BioPharma Inc., Boulder, CO, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Service of Dermatology, Department of Medicine and Paris-Sud University, Gustave Roussy, Villejuif, France.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.07.016']
1798,31886194,Effect of Ajwa Dates Consumption to Inhibit the Progression of Preeclampsia Threats on Mean Arterial Pressure and Roll-Over Test.,"Background


Preeclampsia is the major problem and the main leading cause of fetal and maternal mortality worldwide. The early prediction of preeclampsia in pregnant women is required to prevent the occurrence of preeclampsia. The mean arterial pressure (MAP) and roll-over test (ROT) are the combination of measurement which can be used to predict preeclampsia. On the contrary, Ajwa dates were reported to have an enormous activity which contributes to its role in improving health conditions. In this study, we aimed to evaluate the effect of daily consumption of seven Ajwa dates on prevention of preeclampsia, through MAP and ROT changes.
Methods


Forty pregnant women ( n  = 40) were randomly assigned into the control group ( n  = 10) and the intervention group which received a daily intake of Ajwa dates ( n  = 30). The MAP and ROT were assessed before and after the 8-week intervention period.
Results


The intervention group showed the significant reduction in MAP and ROT following the 8-week intervention period ( p  < 0.05).
Conclusion


Daily consumption of seven Ajwa dates has a remarkable potential to decrease the MAP and ROT in pregnant women at risk of developing preeclampsia, and thus, it can contribute to prevent the development of preeclampsia.",2019,"The intervention group showed the significant reduction in MAP and ROT following the 8-week intervention period ( p  < 0.05).
","['pregnant women', 'pregnant women at risk of developing preeclampsia', 'Forty pregnant women ( n \u2009=\u200940']",['Ajwa Dates Consumption'],"['MAP and ROT', 'prevention of preeclampsia, through MAP and ROT changes', 'Progression of Preeclampsia Threats on Mean Arterial Pressure and Roll-Over Test', 'mean arterial pressure (MAP) and roll-over test (ROT']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}]","[{'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0543436', 'cui_str': 'Does roll over (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",40.0,0.0568345,"The intervention group showed the significant reduction in MAP and ROT following the 8-week intervention period ( p  < 0.05).
","[{'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Royani', 'Affiliation': 'Department of Nutritional Science, Faculty of Medicine, Universitas Muslim Indonesia, Makassar 90231, Indonesia.'}, {'ForeName': 'Suryani', 'Initials': 'S', 'LastName': ""As'ad"", 'Affiliation': 'Department of Nutritional Science, Faculty of Medicine, Hasanuddin University, Makassar 90245, Indonesia.'}, {'ForeName': 'Nasrudin A', 'Initials': 'NA', 'LastName': 'Mappaware', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, Universitas Muslim Indonesia, Makassar 90231, Indonesia.'}, {'ForeName': 'Mochammad', 'Initials': 'M', 'LastName': 'Hatta', 'Affiliation': 'Department of Microbiology, Faculty of Medicine, Hasanuddin University, Makassar 90245, Indonesia.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Rabia', 'Affiliation': 'Department of Physiotherapy, Faculty of Nursing, Hasanuddin University, Makassar 90245, Indonesia.'}]",BioMed research international,['10.1155/2019/2917895']
1799,31888595,Active learning through discussion: ICAP framework for education in health professions.,"BACKGROUND


The ICAP framework based on cognitive science posits four modes of cognitive engagement: Interactive, Constructive, Active, and Passive. Focusing on the wide applicability of discussion as interactive engagement in medical education, we investigated the effect of discussion when it was preceded by self-study and further investigated the effect of generating questions before discussions.
METHODS


This study was conducted in the second semester of 2018 and was participated in by 129 students majoring in health professions, including medicine, dentistry, veterinary medicine, and nursing. The students were assigned to four different trial groups and were asked to fill out a Subjective Mental Effort Questionnaire after completing each session. Their performance in posttest scores was analyzed using Bonferroni test, and mental effort was analyzed using mediation analysis.
RESULTS


These results indicated that the self-study and question group had the highest performance and that the lecture and summary group had the lowest performance when comparing the total score. Using the analysis of mental effort, it was confirmed that the relationship between different study conditions and post-test performance was mediated by mental effort during test.
CONCLUSIONS


Our findings support the ICAP framework and provide practical implications for medical education, representing the fact that students learn more when they are involved in active learning activities, such as self-study and question generation, prior to discussions.",2019,"Using the analysis of mental effort, it was confirmed that the relationship between different study conditions and post-test performance was mediated by mental effort during test.
","['second semester of 2018 and was participated in by 129 students majoring in health professions, including medicine, dentistry, veterinary medicine, and nursing']",[],[],"[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0042615', 'cui_str': 'Veterinary Medicine'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}]",[],[],,0.04884,"Using the analysis of mental effort, it was confirmed that the relationship between different study conditions and post-test performance was mediated by mental effort during test.
","[{'ForeName': 'Jaeseo', 'Initials': 'J', 'LastName': 'Lim', 'Affiliation': 'Interdisciplinary Program in Cognitive Science, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Hyunwoong', 'Initials': 'H', 'LastName': 'Ko', 'Affiliation': 'Interdisciplinary Program in Cognitive Science, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Ji Won', 'Initials': 'JW', 'LastName': 'Yang', 'Affiliation': 'Department of Psychology, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Songeui', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Psychology, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Seunghee', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Medical Education, College of Medicine, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Myung-Sun', 'Initials': 'MS', 'LastName': 'Chun', 'Affiliation': 'Research Institute for Veterinary Science, Seoul National University College of Veterinary Medicine, Seoul, South Korea.'}, {'ForeName': 'Jungjoon', 'Initials': 'J', 'LastName': 'Ihm', 'Affiliation': 'Interdisciplinary Program in Cognitive Science, Seoul National University, Seoul, South Korea. ijj127@snu.ac.kr.'}, {'ForeName': 'Jooyong', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Interdisciplinary Program in Cognitive Science, Seoul National University, Seoul, South Korea. jooypark@snu.ac.kr.'}]",BMC medical education,['10.1186/s12909-019-1901-7']
1800,32111479,"The effect of antioxidants on male factor infertility: the Males, Antioxidants, and Infertility (MOXI) randomized clinical trial.","OBJECTIVE


To determine whether antioxidants improve male fertility, as measured by semen parameters and DNA fragmentation at 3 months and pregnancy resulting in live birth after up to 6 months of treatment, among couples with male factor infertility.
DESIGN


Multicenter, double-blind, randomized, placebo-controlled trial with an internal pilot study.
SETTING


Nine fertility centers in the United States from December 2015 to December 2018.
PATIENT(S)


Men (N = 174) with sperm concentration ≤15 million/mL, motility ≤40%, normal morphology ≤4%, or DNA fragmentation >25%, and female partners who were ovulatory, ≤40 years old, and had documented tubal patency.
INTERVENTION(S)


Males randomly assigned to receive an antioxidant formulation (n = 85) containing 500 mg of vitamin C, 400 mg of vitamin E, 0.20 mg of selenium, 1,000 mg of l-carnitine, 20 mg of zinc, 1,000 μg of folic acid, 10 mg of lycopene daily, or placebo (n = 86). Treatment lasted for a minimum of 3 months and maximum of 6 months, and couples attempted to conceive naturally during the first 3 months and with clomiphene citrate with intrauterine insemination of the female partner in months 4 through 6.
MAIN OUTCOME MEASURE(S)


Primary outcome was live birth; secondary outcomes included pregnancy within 6 months of treatment. For the internal pilot, the primary outcomes were semen parameters and sperm DNA fragmentation index after 3 months of treatment.
RESULT(S)


In the Males, Antioxidants, and Infertility (MOXI) study, after 3 months of treatment, the change in sperm concentration differed between the antioxidant group (median -4.0 [interquartile range-12.0, 5.7] million/mL) and placebo group (+2.4 [-9.0, 15.5] million/mL). However, there were no statistically significant differences between the two groups for changes in sperm morphology, motility, or DNA fragmentation. Among the 66 oligospermic men at randomization, sperm concentration did not differ at 3 months between the antioxidant and control groups: 8.5 (4.8, 15.0) million/mL versus 15.0 (6.0, 24.0) million/mL. Of the 75 asthenospermic men, motility did not differ at 3 months: 34% ± 16.3% versus 36.4% ± 15.8%. Among the 44 men with high DNA fragmentation, DNA fragmentation did not differ at 3 months: 29.5% (21.6%, 36.5%) versus 28.0% (20.6%, 36.4%). In the entire cohort, cumulative live birth did not differ at 6 months between the antioxidant and placebo groups: 15% versus 24%.
CONCLUSION(S)


Antioxidants do not improve semen parameters or DNA integrity among men with male factor infertility. Although limited by sample size, this study suggests that antioxidant treatment of the male partner does not improve in vivo pregnancy or live-birth rates.
CLINICAL TRIAL REGISTRATION NUMBER


NCT02421887.",2020,"However, there were no statistically significant differences between the two groups for changes in sperm morphology, motility, or DNA fragmentation.","['male factor infertility', 'men with male factor infertility', 'Men (N = 174) with sperm concentration ≤15 million/mL', 'Nine fertility centers in the United States from December 2015 to December\xa02018', 'couples with male factor infertility', '66 oligospermic men', '44 men with high DNA fragmentation']","['placebo', 'Antioxidants', 'antioxidants', 'clomiphene citrate', 'antioxidant formulation (n = 85) containing 500 mg of vitamin C, 400 mg of vitamin E, 0.20 mg of selenium, 1,000 mg of l-carnitine, 20 mg of zinc, 1,000 μg of folic acid, 10 mg of lycopene daily, or placebo']","['sperm concentration', 'semen parameters and sperm DNA fragmentation index', 'change in sperm concentration', 'cumulative live birth', 'DNA fragmentation', 'sperm morphology, motility, or DNA fragmentation', 'live birth; secondary outcomes included pregnancy within 6 months of treatment', 'tubal patency', 'vivo pregnancy or live-birth rates']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C1261167', 'cui_str': 'Sperm concentration'}, {'cui': 'C1960956', 'cui_str': 'Million/mL'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0087163', 'cui_str': 'l-carnitine'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0065331', 'cui_str': 'lycopene'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C1261167', 'cui_str': 'Sperm concentration'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0037868', 'cui_str': 'Sperm'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0428011', 'cui_str': 'Sperm morphology (observable entity)'}, {'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]",174.0,0.679034,"However, there were no statistically significant differences between the two groups for changes in sperm morphology, motility, or DNA fragmentation.","[{'ForeName': 'Anne Z', 'Initials': 'AZ', 'LastName': 'Steiner', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, North Carolina. Electronic address: anne.steiner@duke.edu.'}, {'ForeName': 'Karl R', 'Initials': 'KR', 'LastName': 'Hansen', 'Affiliation': 'Department of Obstetrics and Gynecology, Health Sciences Center, University of Oklahoma, Oklahoma City, Oklahoma.'}, {'ForeName': 'Kurt T', 'Initials': 'KT', 'LastName': 'Barnhart', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Marcelle I', 'Initials': 'MI', 'LastName': 'Cedars', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California-San Francisco, San Francisco, California.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Department of Obstetrics and Gynecology, Pennsylvania State University, Hershey, Pennsylvania.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Diamond', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical College of Georgia, Augusta University, Augusta, Georgia.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Krawetz', 'Affiliation': 'Department of Obstetrics and Gynecology & Center for Molecular Medicine and Genetics, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Usadi', 'Affiliation': 'Department of Reproductive Endocrinology and Infertility, Atrium Health, Charlotte, North Carolina.'}, {'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Baker', 'Affiliation': 'Department of Obstetrics and Gynecology, Stanford University, Palo Alto, California.'}, {'ForeName': 'R Matthew', 'Initials': 'RM', 'LastName': 'Coward', 'Affiliation': 'Department of Urology, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, New Haven, Connecticut.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wild', 'Affiliation': 'Department of Obstetrics and Gynecology, Health Sciences Center, University of Oklahoma, Oklahoma City, Oklahoma.'}, {'ForeName': 'Puneet', 'Initials': 'P', 'LastName': 'Masson', 'Affiliation': 'Department of Urology, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Smith', 'Affiliation': 'Department of Urology, University of California- San Francisco, San Francisco, California.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Santoro', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado, Denver, Colorado.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Eisenberg', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, New Haven, Connecticut.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Fertility and sterility,['10.1016/j.fertnstert.2019.11.008']
1801,30851191,Conjunctivitis in dupilumab clinical trials.,"BACKGROUND


Dupilumab blocks the shared receptor component for interleukin (IL)-4 and IL-13. It is approved in the U.S.A. for patients aged ≥ 12 years with moderate-to-severe atopic dermatitis (AD) uncontrolled by topical prescription medicines or who cannot use topical medicines, for patients in Japan whose AD is uncontrolled with existing therapies, for patients with moderate-to-severe AD in Europe who are candidates for systemic therapy and for patients aged ≥ 12 years for maintenance treatment of moderate-to-severe asthma uncontrolled with their current medicines. AD trials have reported increased incidence of conjunctivitis for dupilumab vs. placebo.
OBJECTIVES


To characterize further the occurrence and risk factors of conjunctivitis in dupilumab clinical trials.
METHODS


We evaluated randomized placebo-controlled trials of dupilumab in AD (n = 2629), asthma (n = 2876), chronic rhinosinusitis with nasal polyps (CRSwNP) (n = 60) and eosinophilic oesophagitis (EoE) (n = 47).
RESULTS


In most AD trials, dupilumab-treated patients had higher conjunctivitis incidence than placebo controls. Higher baseline AD severity and previous history of conjunctivitis were associated with increased conjunctivitis incidence. Conjunctivitis was mostly mild to moderate. Most cases recovered or resolved during the treatment period; two patients permanently discontinued dupilumab due to conjunctivitis or keratitis. Common treatments included ophthalmic corticosteroids, antibiotics, and antihistamines or mast cell stabilizers. Most cases were diagnosed by the investigators. In asthma and CRSwNP trials, the incidence of conjunctivitis was lower for both dupilumab and placebo than in AD trials; dupilumab did not increase the incidence compared with placebo. In the EoE trial, no patients had conjunctivitis.
CONCLUSIONS


Conjunctivitis was more frequent with dupilumab treatment in most AD trials. In dupilumab trials in other type 2 diseases, incidence of conjunctivitis was overall very low, and was similar for dupilumab and placebo. In AD, the incidence of conjunctivitis was associated with AD severity and prior history of conjunctivitis. The aetiology and treatment of conjunctivitis in dupilumab-treated patients require further study. What's already known about this topic? Ocular disorders, including allergic conjunctivitis, are common in patients with atopic dermatitis (AD). In most dupilumab AD trials, dupilumab-treated patients had higher conjunctivitis incidence than those receiving placebo. Most cases were mild to moderate and recovered or were recovering during study treatment; study treatment discontinuation due to conjunctivitis was rare. Conjunctivitis incidence was very low and similar for dupilumab and placebo in clinical trials in asthma, chronic rhinosinusitis with nasal polyps and eosinophilic oesophagitis. What does this study add? This analysis confirms and extends the results of the individual clinical trials. Baseline disease-related factors, including AD severity, prior conjunctivitis history and certain biomarkers (thymus and activation-regulated chemokine, IgE, eosinophils), were associated with increased incidence of conjunctivitis. Patients who responded well to dupilumab had reduced incidence of conjunctivitis. Further study is needed to elucidate the aetiology and treatment of conjunctivitis in dupilumab-treated patients with AD.",2019,"In asthma and CRSwNP trials, the incidence of conjunctivitis was lower for both dupilumab and placebo than in AD trials; dupilumab did not increase the incidence compared with placebo.","['patients aged ≥ 12 years with moderate-to-severe atopic dermatitis (AD) uncontrolled by topical prescription medicines or who cannot use', 'patients with moderate-to-severe AD in Europe who are candidates for systemic therapy and for patients aged ≥ 12 years for maintenance treatment of moderate-to-severe asthma uncontrolled with their current medicines', 'in AD (n = 2629), asthma (n = 2876), chronic rhinosinusitis with nasal polyps (CRSwNP) (n = 60) and eosinophilic oesophagitis (EoE) (n = 47']","['topical medicines', 'placebo', 'dupilumab']","['conjunctivitis incidence', 'conjunctivitis', 'conjunctivitis or keratitis', 'ophthalmic corticosteroids, antibiotics, and antihistamines or mast cell stabilizers', 'incidence of conjunctivitis', 'Conjunctivitis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0445107', 'cui_str': 'Not used (qualifier value)'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C4524092', 'cui_str': 'Chronic rhinosinusitis with nasal polyps'}, {'cui': 'C0341106', 'cui_str': 'Chronic Esophagitis, Eosinophilic'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}]","[{'cui': 'C0009763', 'cui_str': 'Conjunctivitis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0022568', 'cui_str': 'Keratitis'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}, {'cui': 'C1268905', 'cui_str': 'Mast cell stabilizer'}]",2876.0,0.187523,"In asthma and CRSwNP trials, the incidence of conjunctivitis was lower for both dupilumab and placebo than in AD trials; dupilumab did not increase the incidence compared with placebo.","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Akinlade', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai Medical Center, New York, NY, U.S.A.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'de Bruin-Weller', 'Affiliation': 'Department of Dermatology & Allergology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland, OR, U.S.A.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, U.S.A.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Cork', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, U.K.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Prens', 'Affiliation': 'Department of Dermatology, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Asbell', 'Affiliation': 'Hamilton Eye Institute, University of Tennessee Health Science Center, Memphis, TN, U.S.A.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Akpek', 'Affiliation': 'Wilmer Eye Institute at Johns Hopkins University School of Medicine, Baltimore, MD, U.S.A.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Corren', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA, U.S.A.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bachert', 'Affiliation': 'ENT Department, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Hirano', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL, U.S.A.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Weyne', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Korotzer', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hultsch', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, U.S.A.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Davis', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mannent', 'Affiliation': 'Sanofi R&D, Chilly-Mazarin, France.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Hamilton', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Teper', 'Affiliation': 'Sanofi, Bridgewater, NJ, U.S.A.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Staudinger', 'Affiliation': 'Sanofi, Bridgewater, NJ, U.S.A.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rizova', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, U.S.A.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pirozzi', 'Affiliation': 'Sanofi, Bridgewater, NJ, U.S.A.'}, {'ForeName': 'N M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Shumel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ardeleanu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wollenberg', 'Affiliation': 'Ludwig-Maximilian University, Munich, Germany.'}]",The British journal of dermatology,['10.1111/bjd.17869']
1802,31781724,Physical Function and Strength in Relation to Inflammation in Older Adults with Obesity and Increased Cardiometabolic Risk.,"BACKGROUND


Inflammation is implicated in functional decline and the development of disability in aging. This study aimed to investigate the association of inflammation with physical function and muscle strength in older adults with obesity and increased cardiometabolic risk.
DESIGN


In baseline assessments from the CROSSROADS randomized controlled trial, serum interleukin-6 (IL-6), tumor necrosis factor-α (TNFα) and C-reactive protein (hs-CRP) were assayed in 163 older adults (37% males, 24% African American, BMI 34±3, age 70±5yrs) with hypertension, dyslipidemia and/or diabetes. Physical function was assessed by six-minute walk test (6MWT), chair sit-and-reach (CSR), hand-grip and knee-extension strength; specific-strength as muscle strength/mass ratio. Analyses included ANCOVA and multiple linear regression adjusted for thigh skeletal muscle (MRI), arm lean mass (DXA) and moderate-to-vigorous intensity physical activity (MVPA; accelerometry).
RESULTS


Higher hs-CRP (p<0.01) and IL-6 (p=0.07) were associated with lower 6MWT and CSR, respectively. A composite inflammation score combining all 3 inflammatory markers showed the strongest inverse association with 6MWT (p<0.01). MVPA moderated associations such that amongst participants who engaged in low MVPA, 6MWT distances and CSR scores were significantly lower in those with high IL-6 and TNFα (p<0.05), respectively. In participants with high MVPA, higher hs-CRP (p<0.05) and TNFα (p=0.07) were associated with poorer upper-extremity specific-strength.
CONCLUSIONS


Chronic inflammation was associated with poorer physical function and specific strength in older adults with obesity and increased cardiometabolic risk. This association was strongest in participants with multiple elevated inflammatory markers. Physical activity levels below current recommendations mitigated the deleterious effects of inflammation on lower body mobility, underscoring the benefits of exercise for preserving physical function with age.",2019,"In participants with high MVPA, higher hs-CRP (p<0.05) and TNFα (p=0.07) were associated with poorer upper-extremity specific-strength.
","['participants with multiple elevated inflammatory markers', 'Older Adults with Obesity and Increased Cardiometabolic Risk', 'older adults with obesity and increased cardiometabolic risk', '163 older adults (37% males, 24% African American, BMI 34±3, age 70±5yrs) with hypertension, dyslipidemia and/or diabetes']",[],"['six-minute walk test (6MWT), chair sit-and-reach (CSR), hand-grip and knee-extension strength; specific-strength as muscle strength/mass ratio', 'physical function and specific strength', 'IL-6', '6MWT distances and CSR scores', 'poorer upper-extremity specific-strength', 'serum interleukin-6 (IL-6), tumor necrosis factor-α (TNFα) and C-reactive protein (hs-CRP', 'Physical function', 'ANCOVA and multiple linear regression adjusted for thigh skeletal muscle (MRI), arm lean mass (DXA) and moderate-to-vigorous intensity physical activity (MVPA; accelerometry']","[{'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]",[],"[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1264679', 'cui_str': 'Mass ratio'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0023733', 'cui_str': 'Linear Regression'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}]",163.0,0.0521846,"In participants with high MVPA, higher hs-CRP (p<0.05) and TNFα (p=0.07) were associated with poorer upper-extremity specific-strength.
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tay', 'Affiliation': 'Jeannie Tay, Department of Nutrition Sciences, University of Alabama at Birmingham, 514 Webb Building, 1675 University Blvd, Birmingham, AL 35294-3360, USA. Email: jeantay@uab.edu.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Goss', 'Affiliation': ''}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Locher', 'Affiliation': ''}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Ard', 'Affiliation': ''}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Gower', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-019-1260-4']
1803,31475391,Health visitors' competences before and after implementing the newborn behavioral observations (NBO) system in a community setting: A cluster randomised study.,"OBJECTIVE


To explore differences between health visitors' competences before and after implementing the newborn behavioral observations (NBO) system in four Danish municipalities.
DESIGN AND SAMPLE


In a cluster randomized design, 56 and 55 health visitors were enrolled in the intervention and comparison districts. Only health visitors from the intervention district received the NBO education programme.
MEASUREMENTS


Data from self-administered questionnaires on heath visitors' intention, self-efficacy, knowledge, and observation skills were collected before and after NBO training. Data were analysed using descriptive and multivariable analyses.
RESULTS


Health visitors reported high levels of intention, self-efficacy, and knowledge working with early parent-infant relationships in both groups at baseline. After implementing NBO, the intervention health visitors reported a significantly higher level of knowledge of infant self-regulation than the comparison group. No significant differences were found in health visitors' level of intention and self-efficacy working with early parent-infant relationships, or in health visitors' observation skills assessing the quality of early relationship.
CONCLUSIONS


Health visitors attending the NBO education and working with NBO in clinical practise had a significantly higher level of knowledge of infant self-regulation. A new discussion of how to educate health visitors' competencies working with early relationship in clinical practise is needed.",2019,"No significant differences were found in health visitors' level of intention and self-efficacy working with early parent-infant relationships, or in health visitors' observation skills assessing the quality of early relationship.
","['four Danish municipalities', '56 and 55 health visitors were enrolled in the intervention and comparison districts']",[],"['levels of intention, self-efficacy, and knowledge working with early parent-infant relationships', ""heath visitors' intention, self-efficacy, knowledge, and observation skills"", ""health visitors' level of intention and self-efficacy working with early parent-infant relationships, or in health visitors' observation skills assessing the quality of early relationship"", 'level of knowledge of infant self-regulation']","[{'cui': 'C0600182'}, {'cui': 'C0018765', 'cui_str': 'Health Visitors'}]",[],"[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0018765', 'cui_str': 'Health Visitors'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}]",,0.0413392,"No significant differences were found in health visitors' level of intention and self-efficacy working with early parent-infant relationships, or in health visitors' observation skills assessing the quality of early relationship.
","[{'ForeName': 'Ingeborg H', 'Initials': 'IH', 'LastName': 'Kristensen', 'Affiliation': 'Section for Nursing, Department of Public Health, Aarhus University, Aarhus C, Denmark.'}, {'ForeName': 'Merethe', 'Initials': 'M', 'LastName': 'Vinter', 'Affiliation': 'Health Department, Thisted, Denmark.'}, {'ForeName': 'Inge K', 'Initials': 'IK', 'LastName': 'Nickell', 'Affiliation': 'The Brazelton Centre UK, Cambridge, UK.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Kronborg', 'Affiliation': 'Section for Nursing, Department of Public Health, Aarhus University, Aarhus C, Denmark.'}]","Public health nursing (Boston, Mass.)",['10.1111/phn.12658']
1804,12649946,Effect of vitamin A supplementation on childhood morbidity and mortality.,"In a double blind design, 1520 children aged < 10 years were individually randomised in vitamin A and placebo group in slums of Chandigarh. Children > 12, 6-12 and < 6 months of age received 200,000, 100,000, 500,000 I.U. of vitamin A respectively every 4 to 6 months during 15 months trial period. The prevalence of vitamin A deficiency was significantly reduced in vitamin A compared to placebo group during the follow-up period. In vitamin A group, incidence of diarrhoea and measles was significantly reduced but incidence of acute respiratory infections was not significantly different compared to control group. Risk of death was also significantly less in vitamin A group. Therefore, promotion of vitamin A rich diet or supplementation with synthetic vitamin A at 4-6 month interval should be a priority in populations where risk of vitamin A deficiency is high.",2002,"In vitamin A group, incidence of diarrhoea and measles was significantly reduced but incidence of acute respiratory infections was not significantly different compared to control group.","['1520 children aged < 10 years', 'Children > 12, 6-12 and < 6 months of age received 200,000, 100,000, 500,000 I.U. of']","['vitamin A supplementation', 'vitamin', 'placebo', 'vitamin A and placebo']","['incidence of diarrhoea and measles', 'acute respiratory infections', 'childhood morbidity and mortality', 'Risk of death', 'prevalence of vitamin A deficiency']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C4524019', 'cui_str': 'Vitamin A supplementation'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0025007', 'cui_str': 'Rubeola'}, {'cui': 'C0339901', 'cui_str': 'ARI - Acute respiratory infections'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0042842', 'cui_str': 'Vitamin A Deficiency'}]",1520.0,0.216175,"In vitamin A group, incidence of diarrhoea and measles was significantly reduced but incidence of acute respiratory infections was not significantly different compared to control group.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chowdhury', 'Affiliation': 'Community Medicine Department, PGIMER, Chandigarh 160012.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'N K', 'Initials': 'NK', 'LastName': 'Ganguly', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'B N S', 'Initials': 'BN', 'LastName': 'Walia', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1805,12508627,DOTS versus self administered therapy (SAT) for patients of pulmonary tuberculosis: a randomised trial at a tertiary care hospital.,"Tuberculosis is a major public health problem in a developing country like India, it is made worse by poor adherence to and frequent interruption of treatment. Treatment of tuberculosis requires strict discipline in order to eradicate mycobacteria and to cure the disease. In the present study we have conducted a randomized control trial, to compare the effectiveness of Directly Observed Therapy Short Course (DOTS) versus Self Administered Therapy (SAT) in a tertiary care hospital.",2002,"Tuberculosis is a major public health problem in a developing country like India, it is made worse by poor adherence to and frequent interruption of treatment.",['patients of pulmonary tuberculosis'],"['DOTS versus self administered therapy (SAT', 'Directly Observed Therapy Short Course (DOTS) versus Self Administered Therapy (SAT']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}]","[{'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0872145', 'cui_str': 'Directly Observed Therapy'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}]",[],,0.0922277,"Tuberculosis is a major public health problem in a developing country like India, it is made worse by poor adherence to and frequent interruption of treatment.","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Tandon', 'Affiliation': 'Departments of Chest, and Pharmacology, PT.B.D. Sharma Post Graduate Institute of Medical Sciences, Rohtak 124001.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tandon', 'Affiliation': ''}, {'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Gupta', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1806,12508631,Topical phenytoin in diabetic ulcers: a double blind controlled trial.,"Data of 57 patients who completed the trial and 13 who did not, were analysed. With phenytoin, there was a marginal: increase in the reduction of mean ulcer area and acceleration of effect 3rd on 4th week. With control: the number completing the trial was larger: response to treatment was better in grade II ulcers, Table IV. This study has the hall marks of a real clinical trial, has raised the possibility of wound healing properties of phenytoin and confirms the results of others.",2001,"With phenytoin, there was a marginal: increase in the reduction of mean ulcer area and acceleration of effect 3rd on 4th week.","['57 patients who completed the trial and 13 who did not, were analysed', 'diabetic ulcers']","['phenytoin', 'Topical phenytoin']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0031507', 'cui_str': 'Phenytoin'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]",[],57.0,0.0869984,"With phenytoin, there was a marginal: increase in the reduction of mean ulcer area and acceleration of effect 3rd on 4th week.","[{'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Pai', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Sitaraman', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Kotian', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1807,30318931,The feasibility of an automatic prompting system in assisting people with traumatic brain injury in cooking tasks.,"Purpose:  Individuals with traumatic brain injury (TBI) often experience difficulties in performing kitchen-related sequencing tasks due to cognitive deficits. The primary aim of this study is to examine the feasibility of a context-aware automatic prompting system in assisting individuals with TBI in multi-step cooking tasks. Method:  Sixteen individuals with TBI participated in the study. A randomized cross-over design was used to compare the automatic prompting method with a conventional user-controlled method through a tablet device. Participant performance under each prompting method was assessed using the Performance Assessment of Self-Care Skills in terms of independence, safety, and adequacy. Subjective workload and qualitative feedback were also collected. Results:  The automatic method, when compared with the user-controlled method, significantly decreased the amount of external assistance required by participants, received higher ratings in user perceived ease-of-use, and was considered less stressful for participants. However, the user-controlled method showed strengths in offering participants more flexibility in terms of controlling on the timing of prompts. Conclusions:  The results provided insight into the potential benefits and user perceptions of a context-aware prompting system. The information could contribute to the future development of advanced prompting technology for people with cognitive impairments in completing sequential tasks.Implications for RehabilitationFor people with traumatic brain injury, the context-aware prompting method showed advantages in improving user performance, receiving better ratings on ease-of-use, and decreasing stress levels, compared to the user-controlled prompting method in completing multi-step cooking tasks.Future prompting systems for people with cognitive impairments may allow users to control the pace of prompting and use sensing information as back-up assistance in critical situations. In this way, the system may help users monitor their actions and offer confirmations, especially at steps with safety concerns, thus enhancing the sense of security and reducing the stress from self-monitoring.",2019,"The automatic method, when compared with the user-controlled method, significantly decreased the amount of external assistance required by participants, received higher ratings in user perceived ease-of-use, and was considered less stressful for participants.","['Individuals with traumatic brain injury (TBI', 'Sixteen individuals with TBI participated in the study', 'assisting people with traumatic brain injury in cooking tasks', 'people with cognitive impairments', 'assisting individuals with TBI in multi-step cooking tasks']","['Rehabilitation', 'automatic prompting system']","['amount of external assistance', 'Subjective workload and qualitative feedback']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C1261552', 'cui_str': 'Step'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",16.0,0.0254196,"The automatic method, when compared with the user-controlled method, significantly decreased the amount of external assistance required by participants, received higher ratings in user perceived ease-of-use, and was considered less stressful for participants.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Science and Technology School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Harshal P', 'Initials': 'HP', 'LastName': 'Mahajan', 'Affiliation': 'Department of Rehabilitation Science and Technology School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Pamela E', 'Initials': 'PE', 'LastName': 'Toto', 'Affiliation': 'Department of Occupational Therapy School of Health and Rehabilitation Sciences, 6425 Penn Avenue, Suite 400 Pittsburgh, PA 15206, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'McCue', 'Affiliation': 'Department of Rehabilitation Science and Technology School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ding', 'Affiliation': 'Department of Rehabilitation Science and Technology School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Disability and rehabilitation. Assistive technology,['10.1080/17483107.2018.1499144']
1808,31099946,Closed loop control in adolescents and children during winter sports: Use of the Tandem Control-IQ AP system.,"OBJECTIVE


Artificial pancreas (AP) systems have been shown to improve glycemic control throughout the day and night in adults, adolescents, and children. However, AP testing remains limited during intense and prolonged exercise in adolescents and children. We present the performance of the Tandem Control-IQ AP system in adolescents and children during a winter ski camp study, where high altitude, low temperature, prolonged intense activity, and stress challenged glycemic control.
METHODS


In a randomized controlled trial, 24 adolescents (ages 13-18 years) and 24 school-aged children (6-12 years) with Type 1 diabetes (T1D) participated in a 48 hours ski camp (∼5 hours skiing/day) at three sites: Wintergreen, VA; Kirkwood, and Breckenridge, CO. Study participants were randomized 1:1 at each site. The control group used remote monitored sensor-augmented pump (RM-SAP), and the experimental group used the t: slim X2 with Control-IQ Technology AP system. All subjects were remotely monitored 24 hours per day by study staff.
RESULTS


The Control-IQ system improved percent time within range (70-180 mg/dL) over the entire camp duration: 66.4 ± 16.4 vs 53.9 ± 24.8%; P = .01 in both children and adolescents. The AP system was associated with a significantly lower average glucose based on continuous glucose monitor data: 161 ± 29.9 vs 176.8 ± 36.5 mg/dL; P = .023. There were no differences between groups for hypoglycemia exposure or carbohydrate interventions. There were no adverse events.
CONCLUSIONS


The use of the Control-IQ AP improved glycemic control and safely reduced exposure to hyperglycemia relative to RM-SAP in pediatric patients with T1D during prolonged intensive winter sport activities.",2019,The AP system was associated with a significantly lower average glucose based on continuous glucose monitor data: 161 ± 29.9 vs 176.8 ± 36.5 mg/dL; P = .023.,"['24 adolescents (ages 13-18 years) and 24 school-aged children (6-12 years) with Type 1 diabetes (T1D) participated in a 48\u2009hours ski camp (∼5 hours skiing/day) at three sites: Wintergreen, VA; Kirkwood, and Breckenridge, CO', 'adolescents and children', 'adolescents and children during a winter ski camp study', 'adolescents and children during winter sports', 'pediatric patients with T1D during prolonged intensive winter sport activities', 'adults, adolescents, and children']","['Tandem Control-IQ AP system', 'Closed loop control', 'remote monitored sensor-augmented pump (RM-SAP), and the experimental group used the t: slim X2 with Control-IQ Technology AP system', 'Control-IQ AP']",['hypoglycemia exposure or carbohydrate interventions'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0037262', 'cui_str': 'SKI (body structure)'}, {'cui': 'C0012054', 'cui_str': ""N',O'-Dibutyryl-cAMP""}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0037264', 'cui_str': 'Snow Skiing'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}]",24.0,0.0322641,The AP system was associated with a significantly lower average glucose based on continuous glucose monitor data: 161 ± 29.9 vs 176.8 ± 36.5 mg/dL; P = .023.,"[{'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Ekhlaspour', 'Affiliation': 'Department of Pediatrics, Stanford University, Palo Alto, California.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Forlenza', 'Affiliation': 'Barbara Davis Center for Childhood Diabetes, University of Colorado Denver, Aurora, Colorado.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Chernavvsky', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Maahs', 'Affiliation': 'Department of Pediatrics, Stanford University, Palo Alto, California.'}, {'ForeName': 'R Paul', 'Initials': 'RP', 'LastName': 'Wadwa', 'Affiliation': 'Barbara Davis Center for Childhood Diabetes, University of Colorado Denver, Aurora, Colorado.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Deboer', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Laurel H', 'Initials': 'LH', 'LastName': 'Messer', 'Affiliation': 'Barbara Davis Center for Childhood Diabetes, University of Colorado Denver, Aurora, Colorado.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Town', 'Affiliation': 'Department of Pediatrics, Stanford University, Palo Alto, California.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pinnata', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Geoff', 'Initials': 'G', 'LastName': 'Kruse', 'Affiliation': 'Tandem Diabetes Care, San Diego, California.'}, {'ForeName': 'Boris P', 'Initials': 'BP', 'LastName': 'Kovatchev', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Buckingham', 'Affiliation': 'Department of Pediatrics, Stanford University, Palo Alto, California.'}, {'ForeName': 'Marc D', 'Initials': 'MD', 'LastName': 'Breton', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia.'}]",Pediatric diabetes,['10.1111/pedi.12867']
1809,31935026,Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression Among Men With Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial.,"Importance


Guidelines endorsing vegetable-enriched diets to improve outcomes for prostate cancer survivors are based on expert opinion, preclinical studies, and observational data.
Objective


To determine the effect of a behavioral intervention that increased vegetable intake on cancer progression in men with early-stage prostate cancer.
Design, Setting, and Participants


The Men's Eating and Living (MEAL) Study (CALGB 70807 [Alliance]) was a randomized clinical trial conducted at 91 US urology and medical oncology clinics that enrolled 478 men aged 50 to 80 years with biopsy-proven prostate adenocarcinoma (International Society of Urological Pathology grade group = 1 in those <70 years and ≤2 in those ≥70 years), stage cT2a or less, and serum prostate-specific antigen (PSA) level less than 10 ng/mL. Enrollment occurred from January 2011 to August 2015; 24-month follow-up occurred from January 2013 to August 2017.
Interventions


Patients were randomized to a counseling behavioral intervention by telephone promoting consumption of 7 or more daily vegetable servings (MEAL intervention; n = 237) or a control group, which received written information about diet and prostate cancer (n = 241).
Main Outcomes and Measures


The primary outcome was time to progression; progression was defined as PSA level of 10 ng/mL or greater, PSA doubling time of less than 3 years, or upgrading (defined as increase in tumor volume or grade) on follow-up prostate biopsy.
Results


Among 478 patients randomized (mean [SD] age, 64 [7] years; mean [SD] PSA level, 4.9 [2.1] ng/mL), 443 eligible patients (93%) were included in the primary analysis. There were 245 progression events (intervention: 124; control: 121). There were no significant differences in time to progression (unadjusted hazards ratio, 0.96 [95% CI, 0.75 to 1.24]; adjusted hazard ratio, 0.97 [95% CI, 0.76 to 1.25]). The 24-month Kaplan-Meier progression-free percentages were 43.5% [95% CI, 36.5% to 50.6%] and 41.4% [95% CI, 34.3% to 48.7%] for the intervention and control groups, respectively (difference, 2.1% [95% CI, -8.1% to 12.2%]).
Conclusions and Relevance


Among men with early-stage prostate cancer managed with active surveillance, a behavioral intervention that increased vegetable consumption did not significantly reduce the risk of prostate cancer progression. The findings do not support use of this intervention to decrease prostate cancer progression in this population, although the study may have been underpowered to identify a clinically important difference.
Trial Registration


ClinicalTrials.gov Identifier: NCT01238172.",2020,"There were no significant differences in time to progression (unadjusted hazards ratio, 0.96","['Men', '64 [7] years; mean [SD] PSA level, 4.9 [2.1] ng/mL), 443 eligible patients (93%) were included in the primary analysis', 'men with early-stage prostate cancer', 'men with early-stage prostate cancer managed with active surveillance', ""Participants\n\n\nThe Men's Eating and Living (MEAL) Study (CALGB 70807"", 'With Early-Stage Prostate Cancer', '478 patients randomized (mean [SD] age', '91 US urology and medical oncology clinics that enrolled 478 men aged 50 to 80 years with biopsy-proven prostate adenocarcinoma (International Society of Urological Pathology grade group\u2009=\u20091 in those <70 years and ≤2 in those ≥70 years), stage cT2a or less, and serum prostate-specific antigen (PSA) level', 'prostate cancer survivors']","['Guidelines endorsing vegetable-enriched diets', 'counseling behavioral intervention by telephone promoting consumption of 7 or more daily vegetable servings (MEAL intervention; n\u2009=\u2009237) or a control group, which received written information about diet and prostate cancer (n\u2009=\u2009241', 'behavioral intervention that increased vegetable intake', 'Behavioral Intervention to Increase Vegetable Consumption']","['time to progression; progression', 'Cancer Progression', 'PSA level of 10 ng/mL or greater, PSA doubling time of less than 3 years, or upgrading (defined as increase in tumor volume or grade', 'cancer progression', '24-month Kaplan-Meier progression-free percentages', 'time to progression', 'risk of prostate cancer progression', 'prostate cancer progression']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1827061', 'cui_str': 'Active surveillance'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0025098', 'cui_str': 'Medical Oncology'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake (observable entity)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0475276', 'cui_str': 'Tumor Volume'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",478.0,0.259409,"There were no significant differences in time to progression (unadjusted hazards ratio, 0.96","[{'ForeName': 'J Kellogg', 'Initials': 'JK', 'LastName': 'Parsons', 'Affiliation': 'Department of Urology, UC San Diego Moores Comprehensive Cancer Center and VA San Diego Healthcare System, La Jolla, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zahrieh', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Mohler', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Electra', 'Initials': 'E', 'LastName': 'Paskett', 'Affiliation': 'Comprehensive Cancer Center, Department of Medicine, The Ohio State University College of Medicine, Columbus.'}, {'ForeName': 'Donna E', 'Initials': 'DE', 'LastName': 'Hansel', 'Affiliation': 'Department of Pathology, University of California, San Diego, La Jolla.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Kibel', 'Affiliation': ""Division of Urology, Dana-Farber/Brigham and Women's Cancer Center, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Heshan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Drew K', 'Initials': 'DK', 'LastName': 'Seisler', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Loki', 'Initials': 'L', 'LastName': 'Natarajan', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Department of Family Medicine and Public Health and UC San Diego Moores Comprehensive Cancer Center, La Jolla, California.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'White', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Department of Family Medicine and Public Health and UC San Diego Moores Comprehensive Cancer Center, La Jolla, California.'}, {'ForeName': 'Olwen', 'Initials': 'O', 'LastName': 'Hahn', 'Affiliation': 'Alliance Central Protocol Operations, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Alliance Central Protocol Operations, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Sheri J', 'Initials': 'SJ', 'LastName': 'Hartman', 'Affiliation': 'Moores Cancer Center, Department of Family Medicine and Public Health, University of California, San Diego, La Jolla.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Stroup', 'Affiliation': 'Department of Urology, Naval Medical Center San Diego, San Diego, California.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van Veldhuizen', 'Affiliation': 'Menorah Medical Center, Midwest Oncology Associates, Overland Park, Kansas.'}, {'ForeName': 'Lannis', 'Initials': 'L', 'LastName': 'Hall', 'Affiliation': 'Siteman Cancer Center, Department of Radiation Oncology, Washington University, St Peters, Missouri.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Pierce', 'Affiliation': 'Moores Cancer Center, Department of Family Medicine and Public Health, University of California, San Diego, La Jolla.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'Department of Prevention and Population Sciences, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}]",JAMA,['10.1001/jama.2019.20207']
1810,30801889,Vaginoscopy Against Standard Treatment: a randomised controlled trial.,"OBJECTIVE


To evaluate whether vaginoscopy or standard hysteroscopy was more successful in the outpatient setting.
DESIGN


Randomised controlled multicentre trial.
SETTING


Outpatient hysteroscopy clinics at two UK hospitals.
POPULATION


1597 women aged 16 or older undergoing an outpatient hysteroscopy.
METHODS


Women were allocated to vaginoscopy or standard hysteroscopy using third party randomisation stratified by menopausal status with no blinding of participants or clinicians.
MAIN OUTCOME MEASURES


The primary outcome was 'success', a composite endpoint defined as: a complete procedure, no complications, a level of pain acceptable to the patient, and no sign of genitourinary tract infection 2 weeks after the procedure.
RESULTS


Vaginoscopy was significantly more successful than standard hysteroscopy [647/726 (89%) versus 621/734 (85%), respectively; relative risk (RR) 1.05, 95% CI 1.01-1.10; P = 0.01]. The median time taken to complete vaginoscopy was 2 minutes compared with 3 minutes for standard hysteroscopy (P < 0.001). The mean pain score was 42.7 for vaginoscopy, which was significantly less than standard hysteroscopy 46.4 (P = 0.02). Operative complications occurred in five women receiving vaginoscopy and 19 women receiving standard hysteroscopy (RR 0.26, 95% CI 0.10-0.69).
CONCLUSIONS


Vaginoscopy is quicker to perform, less painful, and more successful than standard hysteroscopy and therefore should be considered the technique of choice for outpatient hysteroscopy.
TWEETABLE ABSTRACT


Vaginoscopy is quicker to perform, less painful, and more successful than standard hysteroscopy.",2019,"RESULTS


Vaginoscopy was significantly more successful than standard hysteroscopy [647/726 (89%) versus 621/734 (85%), respectively; relative risk (RR) 1.05, 95% CI 1.01-1.10; P = 0.01].","['Women', 'Outpatient hysteroscopy clinics at two UK hospitals', '1597 women aged 16 or older undergoing an outpatient hysteroscopy']","['standard hysteroscopy', 'vaginoscopy or standard hysteroscopy', 'Vaginoscopy Against Standard Treatment', 'vaginoscopy or standard hysteroscopy using third party randomisation stratified by menopausal status with no blinding of participants or clinicians']","['Operative complications', 'mean pain score', ""success', a composite endpoint defined as: a complete procedure, no complications, a level of pain acceptable to the patient, and no sign of genitourinary tract infection"", 'median time taken to complete vaginoscopy']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0020710', 'cui_str': 'Uterine Endoscopy'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0020710', 'cui_str': 'Uterine Endoscopy'}, {'cui': 'C1271437', 'cui_str': 'Endoscopy of vagina (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C1279247', 'cui_str': 'Genitourinary tract infection'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1271437', 'cui_str': 'Endoscopy of vagina (procedure)'}]",1597.0,0.148484,"RESULTS


Vaginoscopy was significantly more successful than standard hysteroscopy [647/726 (89%) versus 621/734 (85%), respectively; relative risk (RR) 1.05, 95% CI 1.01-1.10; P = 0.01].","[{'ForeName': 'P P', 'Initials': 'PP', 'LastName': 'Smith', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical & Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kolhe', 'Affiliation': 'Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': ""O'Connor"", 'Affiliation': ""Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Clark', 'Affiliation': ""Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.""}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.15665']
1811,31092823,"Concentration and avidity of antibodies to different circumsporozoite epitopes correlate with RTS,S/AS01E malaria vaccine efficacy.","RTS,S/AS01E has been tested in a phase 3 malaria vaccine study with partial efficacy in African children and infants. In a cohort of 1028 subjects from one low (Bagomoyo) and two high (Nanoro, Kintampo) malaria transmission sites, we analysed IgG plasma/serum concentration and avidity to CSP (NANP-repeat and C-terminal domains) after a 3-dose vaccination against time to clinical malaria events during 12-months. Here we report that RTS,S/AS01E induces substantial increases in IgG levels from pre- to post-vaccination (p < 0.001), higher in NANP than C-terminus (2855 vs 1297 proportional change between means), and higher concentrations and avidities in children than infants (p < 0.001). Baseline CSP IgG levels are elevated in malaria cases than controls (p < 0.001). Both, IgG magnitude to NANP (hazard ratio [95% confidence interval] 0.61 [0.48-0.76]) and avidity to C-terminus (0.07 [0.05-0.90]) post-vaccination are significantly associated with vaccine efficacy. IgG avidity to the C-terminus emerges as a significant contributor to RTS,S/AS01E-mediated protection.",2019,Baseline CSP IgG levels are elevated in malaria cases than controls (p < 0.001).,"['1028 subjects from one low (Bagomoyo) and two high (Nanoro, Kintampo) malaria transmission sites, we analysed IgG plasma/serum concentration and avidity to CSP (NANP-repeat and C-terminal domains) after a 3-dose vaccination against time to clinical malaria events during 12-months', 'African children and infants']",['NANP'],"['Baseline CSP IgG levels', 'IgG levels', 'Concentration and avidity of antibodies']","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0521124', 'cui_str': 'Against (qualifier value)'}, {'cui': 'C4543807', 'cui_str': 'Clinical malaria'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",[],"[{'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]",1028.0,0.124564,Baseline CSP IgG levels are elevated in malaria cases than controls (p < 0.001).,"[{'ForeName': 'Carlota', 'Initials': 'C', 'LastName': 'Dobaño', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Rosselló 153, 08036, Barcelona, Catalonia, Spain. carlota.dobano@isglobal.org.'}, {'ForeName': 'Hèctor', 'Initials': 'H', 'LastName': 'Sanz', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Rosselló 153, 08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Sorgho', 'Affiliation': 'Unité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de la Santé, BP 218, Nanoro, Burkina Faso.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dosoo', 'Affiliation': 'Kintampo Health Research Centre, P.O. Box 200, Kintampo, Brong-Ahafo, Ghana.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Mpina', 'Affiliation': 'Ifakara Health Institute, Bagamoyo Research and Training Centre, P.O. Box 74, Bagamoyo, Tanzania.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Ubillos', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Rosselló 153, 08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Aguilar', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Rosselló 153, 08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Ford', 'Affiliation': 'IAVI - Human Immunology Laboratory, Imperial College, 369 Fulham Road, London, SW10 9NH, UK.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Díez-Padrisa', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Rosselló 153, 08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Nana Aba', 'Initials': 'NA', 'LastName': 'Williams', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Rosselló 153, 08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Aintzane', 'Initials': 'A', 'LastName': 'Ayestaran', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Rosselló 153, 08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Ousmane', 'Initials': 'O', 'LastName': 'Traore', 'Affiliation': 'Unité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de la Santé, BP 218, Nanoro, Burkina Faso.'}, {'ForeName': 'Augusto J', 'Initials': 'AJ', 'LastName': 'Nhabomba', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Rua 12, Cambeve, Vila de Manhiça, CP 1929, Maputo, Mozambique.'}, {'ForeName': 'Chenjerai', 'Initials': 'C', 'LastName': 'Jairoce', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Rua 12, Cambeve, Vila de Manhiça, CP 1929, Maputo, Mozambique.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Waitumbi', 'Affiliation': 'US Army Medical Research Directorate-Kenya, Walter Reed Army Institute of Research/Kenya Medical Research Institute, Box 54, Kisumu, 40100, Kenya.'}, {'ForeName': 'Selidji Todagbe', 'Initials': 'ST', 'LastName': 'Agnandji', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), BP 242, Lambaréné, Gabon.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kariuki', 'Affiliation': 'Kenya Medical Research Institute/Centre for Global Health, P.O. Box 54840 00200, Kisumu, Siaya, Nairobi, Kenya.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Abdulla', 'Affiliation': 'Ifakara Health Institute, Bagamoyo Research and Training Centre, P.O. Box 74, Bagamoyo, Tanzania.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Aponte', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Rosselló 153, 08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Mordmüller', 'Affiliation': 'Institute of Tropical Medicine and German Center for Infection Research, University of Tübingen, Wilhelmstraße 27, 72074, Tübingen, Germany.'}, {'ForeName': 'Kwaku Poku', 'Initials': 'KP', 'LastName': 'Asante', 'Affiliation': 'Kintampo Health Research Centre, P.O. Box 200, Kintampo, Brong-Ahafo, Ghana.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Owusu-Agyei', 'Affiliation': 'Kintampo Health Research Centre, P.O. Box 200, Kintampo, Brong-Ahafo, Ghana.'}, {'ForeName': 'Halidou', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Unité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de la Santé, BP 218, Nanoro, Burkina Faso.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Campo', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Rosselló 153, 08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Moncunill', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Rosselló 153, 08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Gyan', 'Affiliation': 'Kintampo Health Research Centre, P.O. Box 200, Kintampo, Brong-Ahafo, Ghana.'}, {'ForeName': 'Clarissa', 'Initials': 'C', 'LastName': 'Valim', 'Affiliation': 'Department of Osteopathic Medical Specialties, Michigan State University, 909 Fee Road, Room B 309 West Fee Hall, East Lansing, MI, 48824, USA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Daubenberger', 'Affiliation': 'Swiss Tropical and Public Health Institute, Socinstrasse 57, 4002, Basel, Switzerland.'}]",Nature communications,['10.1038/s41467-019-10195-z']
1812,31376274,Efficacy of a Self-Regulation-Based Electronic and Mobile Health Intervention Targeting an Active Lifestyle in Adults Having Type 2 Diabetes and in Adults Aged 50 Years or Older: Two Randomized Controlled Trials.,"BACKGROUND


Adopting an active lifestyle plays a key role in the prevention and management of chronic diseases such as type 2 diabetes mellitus (T2DM). Web-based interventions are able to alter health behaviors and show stronger effects when they are informed by a behavior change theory. MyPlan 2.0 is a fully automated electronic health (eHealth) and mobile health (mHealth) intervention targeting physical activity (PA) and sedentary behavior (SB) based on the Health Action Process Approach (HAPA).
OBJECTIVE


This study aimed to test the short-term effect of MyPlan 2.0 in altering levels of PA and SB and in changing personal determinants of behavior in adults with T2DM and in adults aged ≥50 years.
METHODS


The study comprised two randomized controlled trials (RCTs) with an identical design. RCT 1 was conducted with adults with T2DM. RCT 2 was performed in adults aged ≥50 years. Data were collected via face-to-face assessments. The participants decided either to increase their level of PA or to decrease their level of SB. The participants were randomly allocated with a 2:1 ratio to the intervention group or the waiting-list control group. They were not blinded for their group allocation. The participants in the intervention group were instructed to go through MyPlan 2.0, comprising 5 sessions with an interval of 1 week between each session. The primary outcomes were objectively measured and self-reported PA (ie, light PA, moderate-to-vigorous PA, total PA, number of steps, and domain-specific [eg, transport-related] PA) and SB (ie, sitting time, number of breaks from sitting time, and length of sitting bouts). Secondary outcomes were self-reported behavioral determinants for PA and SB (eg, self-efficacy). Separate linear mixed models were performed to analyze the effects of MyPlan 2.0 in the two samples.
RESULTS


In RCT 1 (n=54), the PA intervention group showed, in contrast to the control group, a decrease in self-reported time spent sitting (P=.09) and an increase in accelerometer-measured moderate (P=.05) and moderate-to-vigorous PA (P=.049). The SB intervention group displayed an increase in accelerometer-assessed breaks from sedentary time in comparison with the control group (P=.005). A total of 14 participants of RCT 1 dropped out. In RCT 2 (n=63), the PA intervention group showed an increase for self-reported total PA in comparison with the control group (P=.003). Furthermore, in contrast to the control group, the SB intervention group decreased their self-reported time spent sitting (P=.08) and increased their accelerometer-assessed moderate (P=.06) and moderate-to-vigorous PA (P=.07). A total of 8 participants of RCT 2 dropped out.
CONCLUSIONS


For both the samples, the HAPA-based eHealth and mHealth intervention, MyPlan 2.0, was able to improve only some of the primary outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03291171; http://clinicaltrials.gov/ct2/show/NCT03291171. ClinicalTrials.gov NCT03799146; http://clinicaltrials.gov/ct2/show/NCT03799146.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/12413.",2019,The SB intervention group displayed an increase in accelerometer-assessed breaks from sedentary time in comparison with the control group (P=.005).,"['adults with T2DM', 'adults aged ≥50 years', 'adults with T2DM and in adults aged ≥50 years', 'Adults Having Type 2 Diabetes and in Adults Aged 50 Years or Older', '14 participants of RCT 1 dropped out']","['RCT', 'Self-Regulation-Based Electronic and Mobile Health Intervention', 'waiting-list control group', 'mobile health (mHealth) intervention targeting physical activity (PA) and sedentary behavior (SB) based on the Health Action Process Approach (HAPA', 'PA intervention', 'SB intervention', 'MyPlan']","['objectively measured and self-reported PA (ie, light PA, moderate-to-vigorous PA, total PA, number of steps, and domain-specific [eg, transport-related] PA) and SB (ie, sitting time, number of breaks from sitting time, and length of sitting bouts', 'self-reported time spent sitting', 'self-reported behavioral determinants for PA and SB (eg, self-efficacy', 'level of PA or to decrease their level of SB', 'accelerometer-assessed breaks from sedentary time', 'self-reported total PA']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}]","[{'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1271922', 'cui_str': 'Target physical activity'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0445131', 'cui_str': 'Number of breaks (observable entity)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}]",14.0,0.0736983,The SB intervention group displayed an increase in accelerometer-assessed breaks from sedentary time in comparison with the control group (P=.005).,"[{'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Poppe', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'De Bourdeaudhuij', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Maïté', 'Initials': 'M', 'LastName': 'Verloigne', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Samyah', 'Initials': 'S', 'LastName': 'Shadid', 'Affiliation': 'Department of Endocrinology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Jelle', 'Initials': 'J', 'LastName': 'Van Cauwenberg', 'Affiliation': 'Department of Public Health and Primary Care, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Compernolle', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Crombez', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Ghent, Belgium.'}]",Journal of medical Internet research,['10.2196/13363']
1813,31256137,Feasibility of Three Novel Forms of Passive Exercise in a Multisensory Environment in Vulnerable Institutionalized Older Adults with Dementia.,"BACKGROUND


Increasing physical activity levels in patients with dementia can reduce pathology severity and progression of the disease. However, physical activity programs can be challenging to adhere to for this vulnerable population. Three novel forms of passive exercise in a multisensory environment may be feasible alternatives for patients who can no longer be involved in physical activity.
OBJECTIVE


To determine the feasibility of three different forms of passive exercise in a multisensory environment in inactive institutionalized older adults with dementia.
METHODS


120 patients with dementia participated in this single blind randomized controlled trial (64.5% female, age 85.3±6.8 years Mini-Mental State Examination range 0-29). Ninety participants were randomly assigned to one of the three intervention groups: Therapeutic Motion Simulation (TMSim), Whole Body Vibration (WBV), and TMSim + WBV. Participants received 6 weeks of passive exercise, 4 sessions a week, 4 (WBV) to 12 (TMSim and TMSim + WBV) minutes per session. Feasibility of the novel forms of passive exercise was evaluated based on attendance, compliance, (proxy) experience scores, adverse events and drop-out rates.
RESULTS


On average 87.9% of the offered intervention sessions were attended. All three forms of passive exercise were well appreciated by the participants (7.3 on a scale from 0 to 10). Intervention related drop-out rates were reasonable (12.2%) and no serious adverse events occurred.
CONCLUSION


The novel passive exercise interventions TMSim, WBV, and TMSim + WBV are feasible to apply in patients at all stages of dementia. More research is needed to establish effectiveness of passive exercise to limit adverse effects of dementia.",2019,All three forms of passive exercise were well appreciated by the participants (7.3 on a scale from 0 to 10).,"['patients who can no longer be involved in physical activity', 'inactive institutionalized older adults with dementia', 'Ninety participants', 'patients at all stages of dementia', 'patients with dementia', '120 patients with dementia participated in this single blind randomized controlled trial (64.5% female, age 85.3±6.8 years Mini-Mental State Examination range 0-29', 'Vulnerable Institutionalized Older Adults with Dementia']","['passive exercise', 'Therapeutic Motion Simulation (TMSim), Whole Body Vibration (WBV), and TMSim\u200a+\u200aWBV', 'Passive Exercise', 'novel passive exercise interventions TMSim, WBV, and TMSim\u200a+\u200aWBV']","['serious adverse events', 'attendance, compliance, (proxy) experience scores, adverse events and drop-out rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0419121', 'cui_str': 'Passive exercise (regime/therapy)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0044247', 'cui_str': 'TSIM'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}]",120.0,0.0285102,All three forms of passive exercise were well appreciated by the participants (7.3 on a scale from 0 to 10).,"[{'ForeName': 'Marelle', 'Initials': 'M', 'LastName': 'Heesterbeek', 'Affiliation': 'Molecular Neurobiology, Groningen Institute for Evolutionary Life Sciences (GELIFES), University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Eddy Anton', 'Initials': 'EA', 'LastName': 'van der Zee', 'Affiliation': 'Molecular Neurobiology, Groningen Institute for Evolutionary Life Sciences (GELIFES), University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Marieke Joan Gerda', 'Initials': 'MJG', 'LastName': 'van Heuvelen', 'Affiliation': 'Center for Human Movement Sciences, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190309']
1814,31292197,GFR Slope as a Surrogate End Point for Kidney Disease Progression in Clinical Trials: A Meta-Analysis of Treatment Effects of Randomized Controlled Trials.,"BACKGROUND


Surrogate end points are needed to assess whether treatments are effective in the early stages of CKD. GFR decline leads to kidney failure, but regulators have not approved using differences in the change in GFR from the beginning to the end of a randomized, controlled trial as an end point in CKD because it is not clear whether small changes in the GFR slope will translate to clinical benefits.
METHODS


To assess the use of GFR slope as a surrogate end point for CKD progression, we performed a meta-analysis of 47 RCTs that tested 12 interventions in 60,620 subjects. We estimated treatment effects on GFR slope (mean difference in GFR slope between the randomized groups), for the total slope starting at baseline, chronic slope starting at 3 months after randomization, and on the clinical end point (doubling of serum creatinine, GFR<15 ml/min per 1.73 m 2 , or ESKD) for each study. We used Bayesian mixed-effects analyses to describe the association of treatment effects on GFR slope with the clinical end point and to test how well the GFR slope predicts a treatment's effect on the clinical end point.
RESULTS


Across all studies, the treatment effect on 3-year total GFR slope (median  R   2 =0.97; 95% Bayesian credible interval [BCI], 0.78 to 1.00) and on the chronic slope ( R   2  0.96; 95% BCI, 0.63 to 1.00) accurately predicted treatment effects on the clinical end point. With a sufficient sample size, a treatment effect of 0.75 ml/min per 1.73 m 2 /yr or greater on total slope over 3 years or chronic slope predicts a clinical benefit on CKD progress with at least 96% probability.
CONCLUSIONS


With large enough sample sizes, GFR slope may be a viable surrogate for clinical end points in CKD RCTs.",2019,"Across all studies, the treatment effect on 3-year total GFR slope (median  R   2 =0.97; 95% Bayesian credible interval [BCI], 0.78 to 1.00) and on the chronic slope ( R   2  0.96; 95% BCI, 0.63 to 1.00) accurately predicted treatment effects on the clinical end point.","['60,620 subjects']",[],"['3-year total GFR slope', 'GFR slope', 'chronic slope']",[],[],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]",,0.130743,"Across all studies, the treatment effect on 3-year total GFR slope (median  R   2 =0.97; 95% Bayesian credible interval [BCI], 0.78 to 1.00) and on the chronic slope ( R   2  0.96; 95% BCI, 0.63 to 1.00) accurately predicted treatment effects on the clinical end point.","[{'ForeName': 'Lesley A', 'Initials': 'LA', 'LastName': 'Inker', 'Affiliation': 'Division of Nephrology and LInker@tuftsmedicalcenter.org.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Departments of Clinical Pharmacy and Pharmacology and.'}, {'ForeName': 'Hocine', 'Initials': 'H', 'LastName': 'Tighiouart', 'Affiliation': 'The Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Levey', 'Affiliation': 'Division of Nephrology and.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Coresh', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Ron T', 'Initials': 'RT', 'LastName': 'Gansevoort', 'Affiliation': 'Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Simon', 'Affiliation': 'Division of Nephrology and.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Ying', 'Affiliation': 'Division of Epidemiology, Department of Internal Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Beck', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Division of Nephrology, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Floege', 'Affiliation': 'Division of Nephrology, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Philip Kam-Tao', 'Initials': 'PK', 'LastName': 'Li', 'Affiliation': 'Division of Nephrology, Prince of Wales Hospital, Chinese University of Hong Kong, Shatin, Hong Kong; LInker@tuftsmedicalcenter.org.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'George Institute for Global Health, University of New South Wales, Sydney, Australia; and.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Vonesh', 'Affiliation': 'Department of Preventive Medicine, Division of Biostatistics, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'Division of Epidemiology, Department of Internal Medicine, University of Utah, Salt Lake City, Utah.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2019010007']
1815,31292198,Performance of GFR Slope as a Surrogate End Point for Kidney Disease Progression in Clinical Trials: A Statistical Simulation.,"BACKGROUND


Randomized trials of CKD treatments traditionally use clinical events late in CKD progression as end points. This requires costly studies with large sample sizes and long follow-up. Surrogate end points like GFR slope may speed up the evaluation of new therapies by enabling smaller studies with shorter follow-up.
METHODS


We used statistical simulations to identify trial situations where GFR slope provides increased statistical power compared with the clinical end point of doubling of serum creatinine or kidney failure. We simulated GFR trajectories based on data from 47 randomized treatment comparisons. We evaluated the sample size required for adequate statistical power based on GFR slopes calculated from baseline and from 3 months follow-up.
RESULTS


In most scenarios where the treatment has no acute effect, analyses of GFR slope provided similar or improved statistical power compared with the clinical end point, often allowing investigators to shorten follow-up by at least half while simultaneously reducing sample size. When patients' GFRs are higher, the power advantages of GFR slope increase. However, acute treatment effects within several months of randomization can increase the risk of false conclusions about therapies based on GFR slope. Care is needed in study design and analysis to avoid such false conclusions.
CONCLUSIONS


Use of GFR slope can substantially increase statistical power compared with the clinical end point, particularly when baseline GFR is high and there is no acute effect. The optimum GFR-based end point depends on multiple factors including the rate of GFR decline, type of treatment effect and study design.",2019,"In most scenarios where the treatment has no acute effect, analyses of GFR slope provided similar or improved statistical power compared with the clinical end point, often allowing investigators to shorten follow-up by at least half while simultaneously reducing sample size.",[],['CKD'],[],[],[],[],47.0,0.0888945,"In most scenarios where the treatment has no acute effect, analyses of GFR slope provided similar or improved statistical power compared with the clinical end point, often allowing investigators to shorten follow-up by at least half while simultaneously reducing sample size.","[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'Department of Internal Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Ying', 'Affiliation': 'Department of Internal Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Vonesh', 'Affiliation': 'Division of Biostatistics, Department of Preventive Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Hocine', 'Initials': 'H', 'LastName': 'Tighiouart', 'Affiliation': 'Institute for Clinical Research and Health Policy Studies and.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Levey', 'Affiliation': 'Division of Nephrology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Coresh', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Herrick', 'Affiliation': 'Department of Internal Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Enyu', 'Initials': 'E', 'LastName': 'Imai', 'Affiliation': 'Nakayamadera Imai Clinic, Takarazuka, Japan.'}, {'ForeName': 'Tazeen H', 'Initials': 'TH', 'LastName': 'Jafar', 'Affiliation': 'Program in Health Services and Systems Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Bart D', 'Initials': 'BD', 'LastName': 'Maes', 'Affiliation': 'AZ Delta, Roeselare, Belgium.'}, {'ForeName': 'Ronald D', 'Initials': 'RD', 'LastName': 'Perrone', 'Affiliation': 'Division of Nephrology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Del Vecchio', 'Affiliation': 'Department of Nephrology and Dialysis, Alessandro Manzoni Hospital, Lecco, Italy.'}, {'ForeName': 'Jack F M', 'Initials': 'JFM', 'LastName': 'Wetzels', 'Affiliation': 'Department of Nephrology, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands; and.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, The Netherlands.'}, {'ForeName': 'Lesley A', 'Initials': 'LA', 'LastName': 'Inker', 'Affiliation': 'Division of Nephrology, Tufts Medical Center, Boston, Massachusetts; LInker@tuftsmedicalcenter.org.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2019010009']
1816,11887299,Effect of various antihypertensive drugs on plasma fibrinogen levels in patients with essential hypertension.,"In recent years, substantial evidence has accumulated to unambiguously implicate high plasma fibrinogen levels as a major cardiovascular risk factor. An open prospective and randomised pilot study was therefore undertaken in mild to moderate hypertensives to evaluate the effect of various antihypertensive drugs viz enalapril, felodipine and prazosin on the blood pressure and plasma fibrinogen levels. The systolic and diastolic blood pressures were determined at 0, 4 and 8 weeks whereas plasma fibrinogen assays were done at baseline and at the end of the 8th week of treatment in all the drug-treated groups. It was observed that although all the three drugs effectively controlled blood pressure, only enalapril significantly reduced plasma fibrinogen levels. Due to this additional effect, enalapril has potential to control two major cardiovascular risk factors--hypertension and high plasma fibrinogen levels--simultaneously.",2001,"It was observed that although all the three drugs effectively controlled blood pressure, only enalapril significantly reduced plasma fibrinogen levels.","['patients with essential hypertension', 'mild to moderate hypertensives']","['enalapril, felodipine and prazosin', 'various antihypertensive drugs', 'enalapril']","['systolic and diastolic blood pressures', 'blood pressure and plasma fibrinogen levels', 'plasma fibrinogen assays', 'plasma fibrinogen levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0015772', 'cui_str': 'Felodipine'}, {'cui': 'C0032912', 'cui_str': 'Prazosin'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0856510', 'cui_str': 'Plasma fibrinogen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}]",,0.0177306,"It was observed that although all the three drugs effectively controlled blood pressure, only enalapril significantly reduced plasma fibrinogen levels.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bhatia', 'Affiliation': 'Department of Medicine, University College of Medical Sciences & GTB Hospital, Shahdra, Delhi-110095.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mahajan', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sikka', 'Affiliation': ''}, {'ForeName': 'O P', 'Initials': 'OP', 'LastName': 'Kalra', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1817,31334914,Renal denervation in patients with heart failure secondary to Chagas' disease: A pilot randomized controlled trial.,"INTRODUCTION


Chagas disease is one of the most relevant endemic parasitic diseases in Latin America, affecting approximately 6 million people. Overt Chagas heart disease is an ominous condition, occurring in 20-30% of infected individuals, which has besides the persistent myocarditis a peculiar intracardiac ganglionic neuronal depletion and dysautonomy. This study aims to evaluate the safety and feasibility of renal denervation for patients with advanced symptomatic Chagas cardiomyopathy.
METHODS


Open-label prospective pilot study that randomized patients with Chagas heart disease to either renal denervation or conservative treatment (2:1 ratio). The primary endpoint was the incidence of major adverse events at 9 months, defined as a composite of all-cause death, myocardial infarction, stroke, need for renal artery invasive treatment, or worsening renal function.
RESULTS


A total of 17 patients were allocated for renal denervation (n = 11) or conservative treatment (n = 6). Included patients had severe symptomatic heart disease, with markedly depressed left ventricular function (average ejection fraction 26.7 ± 4.9%). For patients randomized to renal denervation, the procedure was performed successfully and uneventfully. After 9 months, the primary endpoint occurred in 36.4% of patients in the renal denervation group and 50.0% in the control arm (p = .6). After 9 months, clinical, laboratory, functional, echocardiographic, and quality of life parameters were similar between groups.
CONCLUSIONS


This pilot study suggests that renal denervation is safe and feasible in patients with Chagas cardiomyopathy, warranting future studies to better evaluate the clinical efficacy of the interventional strategy in improving the prognosis of this high-risk population.",2019,"After 9 months, the primary endpoint occurred in 36.4% of patients in the renal denervation group and 50.0% in the control arm (p = .6).","['randomized patients with Chagas heart disease to either renal denervation or conservative treatment (2:1 ratio', '17 patients were allocated for renal denervation (n = 11) or', 'Included patients had severe symptomatic heart disease, with markedly depressed left ventricular function (average ejection fraction 26.7\u2009±\u20094.9', 'patients with Chagas cardiomyopathy', ""patients with heart failure secondary to Chagas' disease"", 'patients with advanced symptomatic Chagas cardiomyopathy']","['conservative treatment', 'renal denervation']","['clinical, laboratory, functional, echocardiographic, and quality of life parameters', 'incidence of major adverse events at 9 months, defined as a composite of all-cause death, myocardial infarction, stroke, need for renal artery invasive treatment, or worsening renal function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C1321798', 'cui_str': 'Muscle denervation'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0007930', 'cui_str': 'Trypanosomiasis, Cardiovascular'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0041234', 'cui_str': 'Trypanosoma cruzi Infection'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C1321798', 'cui_str': 'Muscle denervation'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0035065', 'cui_str': 'Renal Artery'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",,0.0622165,"After 9 months, the primary endpoint occurred in 36.4% of patients in the renal denervation group and 50.0% in the control arm (p = .6).","[{'ForeName': 'André G', 'Initials': 'AG', 'LastName': 'Spadaro', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Edimar A', 'Initials': 'EA', 'LastName': 'Bocchi', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Germano E', 'Initials': 'GE', 'LastName': 'Souza', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Antonio E', 'Initials': 'AE', 'LastName': 'Filho', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Mariani', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Campos', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Pedro A', 'Initials': 'PA', 'LastName': 'Lemos', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, São Paulo, Brazil.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28393']
1818,11966062,Effect of single dose of prednisolone on hospitalisation in patients of acute bronchial asthma.,"The present study was undertaken to assess the effect of stat dose of oral prednisolone on rate of hospitalisation in patients of acute bronchial asthma. 259 patients, aged 1-65 years presenting with acute exacerbation of asthma were randomised in a double blind fashion to receive a stat dose of oral prednisolonev (30 mg if age < 5 years; 60 mg if age > 5 years) or equivalent placebo. Then, nebulbutamol (0.15 mg/kg in 2 m/l normal saline) was given to all patients and patients were re-examined after 4 hours to decide about the hospitalisation. The study revealed that only 37 (26.42%) patients required hospitalisation and further management in prednisolone group compared to 50 (42.01%) patients in placebo group (p < 0.01). This suggests that prompt use of single oral dose of prednisolone along with routine bronchodilator therapy can significantly reduce morbidity and need for hospital admission in patients of acute bronchial asthma.",2000,The study revealed that only 37 (26.42%) patients required hospitalisation and further management in prednisolone group compared to 50 (42.01%) patients in placebo group (p < 0.01).,"['patients of acute bronchial asthma', '259 patients, aged 1-65 years presenting with acute exacerbation of asthma']","['prednisolone', 'placebo', 'oral prednisolone', 'oral prednisolonev']","['morbidity and need for hospital admission', 'rate of hospitalisation', 'hospitalisation and further management']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0347950', 'cui_str': 'Acute exacerbation of asthma (disorder)'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",259.0,0.294348,The study revealed that only 37 (26.42%) patients required hospitalisation and further management in prednisolone group compared to 50 (42.01%) patients in placebo group (p < 0.01).,"[{'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Mahakalkar', 'Affiliation': 'Dept of Pharmacology, Indira Gandhi Medical College, Nagpur.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tibdewal', 'Affiliation': ''}, {'ForeName': 'B P', 'Initials': 'BP', 'LastName': 'Khobragade', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1819,31439584,Tissue and Plasma EGFR Mutation Analysis in the FLAURA Trial: Osimertinib versus Comparator EGFR Tyrosine Kinase Inhibitor as First-Line Treatment in Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer.,"PURPOSE


To assess the utility of the  cobas  EGFR Mutation Test, with tissue and plasma, for first-line osimertinib therapy for patients with  EGFR -mutated ( EGFR m; Ex19del and/or L858R) advanced or metastatic non-small cell lung cancer (NSCLC) from the FLAURA study (NCT02296125).
EXPERIMENTAL DESIGN


Tumor tissue  EGFR m status was determined at screening using the central cobas tissue test or a local tissue test. Baseline circulating tumor (ct)DNA  EGFR m status was retrospectively determined with the central cobas plasma test.
RESULTS


Of 994 patients screened, 556 were randomized (289 and 267 with central and local  EGFR  test results, respectively) and 438 failed screening. Of those randomized from local  EGFR  test results, 217 patients had available central test results; 211/217 (97%) were retrospectively confirmed  EGFR m positive by central cobas tissue test. Using reference central cobas tissue test results, positive percent agreements with cobas plasma test results for Ex19del and L858R detection were 79% [95% confidence interval (CI), 74-84] and 68% (95% CI, 61-75), respectively. Progression-free survival (PFS) superiority with osimertinib over comparator EGFR-TKI remained consistent irrespective of randomization route (central/local  EGFR m-positive tissue test). In both treatment arms, PFS was prolonged in plasma ctDNA  EGFR m-negative (23.5 and 15.0 months) versus -positive patients (15.2 and 9.7 months).
CONCLUSIONS


Our results support utility of cobas tissue and plasma testing to aid selection of patients with  EGFR m advanced NSCLC for first-line osimertinib treatment. Lack of  EGFR m detection in plasma was associated with prolonged PFS versus patients plasma  EGFR m positive, potentially due to patients having lower tumor burden.",2019,"In both treatment arms, PFS was prolonged in plasma ctDNA  ","['patients with  EGFR m advanced NSCLC for first-line osimertinib treatment', 'patients with  EGFR -mutated ', 'f 994 patients screened, 556 were randomized (289 and 267 with central and local  EGFR  test results, respectively) and 438 failed screening', '217 patients had available central test results; 211/217 (97%) were retrospectively confirmed  EGFR m positive by central cobas tissue test', 'Patients with  EGFR  Mutated Advanced NSCLC']",[],"['EGFR m negative', 'Baseline circulating tumor (ct)DNA  EGFR m status', 'plasma ctDNA', 'Progression-free survival (PFS) superiority']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517811', 'cui_str': 'Five hundred and fifty-six'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}]",[],"[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",994.0,0.0672508,"In both treatment arms, PFS was prolonged in plasma ctDNA  ","[{'ForeName': 'Jhanelle E', 'Initials': 'JE', 'LastName': 'Gray', 'Affiliation': 'Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida. Jhanelle.gray@moffitt.org.'}, {'ForeName': 'Isamu', 'Initials': 'I', 'LastName': 'Okamoto', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Virote', 'Initials': 'V', 'LastName': 'Sriuranpong', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Faculty of Medicine, Chulalongkorn University and the King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Vansteenkiste', 'Affiliation': 'Respiratory Oncology Unit, University Hospital KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Imamura', 'Affiliation': 'Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Jong Seok', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea; and National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Yong-Kek', 'Initials': 'YK', 'LastName': 'Pang', 'Affiliation': 'Division of Respiratory Medicine, Department of Medicine, Faculty of Medicine, University of Malaya Medical Centre, Lembah Pantai, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Cobo', 'Affiliation': 'Medical Oncology Section, Hospital Universitario Málaga Regional, Instituto de Investigación Biomédica de Málaga-IBIMA, Málaga, Spain.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kasahara', 'Affiliation': 'Department of Respiratory Medicine, Kanazawa University Hospital, Kanazawa, Japan.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Oncology, Jilin Provincial Cancer Hospital, Changchun, China.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Nogami', 'Affiliation': 'Department of Thoracic Oncology and Medicine, National Hospital Organization, Shikoku Cancer Centre, Ehime, Japan.'}, {'ForeName': 'Eun Kyung', 'Initials': 'EK', 'LastName': 'Cho', 'Affiliation': 'Division of Oncology, Department of Internal Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, South Korea.'}, {'ForeName': 'Wu Chou', 'Initials': 'WC', 'LastName': 'Su', 'Affiliation': 'National Cheng Kung University Hospital, Tainan, Taiwan.'}, {'ForeName': 'Guili', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Roche Molecular Systems, Pleasanton, California.'}, {'ForeName': 'Xiangning', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Global Medicines Development, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Xiaocheng', 'Initials': 'X', 'LastName': 'Li-Sucholeiki', 'Affiliation': 'Precision Medicine and Genomics, Innovative Medicines and Early Development, AstraZeneca, Boston, Massachusetts.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lentrichia', 'Affiliation': 'Precision Medicine and Genomics, Innovative Medicines and Early Development, AstraZeneca, Boston, Massachusetts.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Dearden', 'Affiliation': 'Precision Medicine and Genomics, Innovative Medicines and Early Development, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Jenkins', 'Affiliation': 'Precision Medicine and Genomics, Innovative Medicines and Early Development, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Saggese', 'Affiliation': 'Global Medicines Development, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Rukazenkov', 'Affiliation': 'Global Medicines Development, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Suresh S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'Emory University School of Medicine, Winship Cancer Institute, Atlanta, Georgia.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-1126']
1820,31251430,A new experimental model of muscle pain in humans based on short-wave diathermy.,"BACKGROUND


Experimental models of pain in humans are crucial for understanding pain mechanisms. The most often used muscle pain models involve the injection of algesic substances, such as hypertonic saline solution or nerve growth factor or the induction of delayed onset muscle soreness (DOMS) by an unaccustomed exercise routine. However, these models are either invasive or take substantial time to develop, and the elicited level of pain/soreness is difficult to control. To overcome these shortcomings, we propose to elicit muscle pain by a localized application of short-wave diathermy (SWD).
METHODS


In this crossover study, SWD was administered to 18 healthy volunteers to the wrist extensor muscle group, with a constant stimulation intensity and up to 4 min. Pressure pain threshold (PPT), pinprick sensitivity (PPS) and self-reported muscle soreness were assessed at baseline and at 0, 30 and 60 min after application of SWD.
RESULTS


SWD evoked localized muscle pain/soreness in the wrist extensor muscle group and a decrease of PPT in the treated arm compared with the control arm that lasted for at least 60 min, reflecting ongoing hyperalgesia after SWD application. PPS was not significantly altered 30-60 min following SWD, suggesting a minimal contribution from skin tissue to sustained hyperalgesia.
CONCLUSIONS


SWD was able to elicit muscle soreness and hyperalgesia up to 60 min after its application. Thus, this new model represents a promising tool for investigating muscle pain in humans.
SIGNIFICANCE


This study presents an experimental model to elicit sustained muscle pain based on short-wave diathermy. The main advantages of the model are its noninvasiveness, the possibility to control stimulation parameters in a reliable way and the convenience of the time frame in which pain and hyperalgesia are developed.",2019,"Pressure pain threshold (PPT), pinprick sensitivity (PPS) and self-reported muscle soreness were assessed at baseline and at 0, 30 and 60 minutes after application of SWD.
","['humans', 'eighteen healthy volunteers to the wrist extensor muscle group, with a constant stimulation intensity and up to 4 minutes']",['SWD'],"['PPT', 'PPS', 'Pressure pain threshold (PPT), pinprick sensitivity (PPS) and self-reported muscle soreness', 'elicit muscle soreness and hyperalgesia', 'SWD evoked localized muscle pain/soreness']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]",[],"[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}]",18.0,0.022376,"Pressure pain threshold (PPT), pinprick sensitivity (PPS) and self-reported muscle soreness were assessed at baseline and at 0, 30 and 60 minutes after application of SWD.
","[{'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Mista', 'Affiliation': 'Institute for Research and Development on Bioengineering and Bioinformatics (IBB), CONICET-UNER, Oro Verde, Argentina.'}, {'ForeName': 'Silvio J', 'Initials': 'SJ', 'LastName': 'Laugero', 'Affiliation': 'Department of Bioengineering, National University of Entre Ríos, Oro Verde, Argentina.'}, {'ForeName': 'Javier F', 'Initials': 'JF', 'LastName': 'Adur', 'Affiliation': 'Institute for Research and Development on Bioengineering and Bioinformatics (IBB), CONICET-UNER, Oro Verde, Argentina.'}, {'ForeName': 'Ole K', 'Initials': 'OK', 'LastName': 'Andersen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI®, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Biurrun Manresa', 'Affiliation': 'Institute for Research and Development on Bioengineering and Bioinformatics (IBB), CONICET-UNER, Oro Verde, Argentina.'}]","European journal of pain (London, England)",['10.1002/ejp.1449']
1821,31447409,"Combination denosumab and high dose teriparatide for postmenopausal osteoporosis (DATA-HD): a randomised, controlled phase 4 trial.","BACKGROUND


In the Denosumab and Teriparatide Administration (DATA) study, we showed that denosumab fully inhibits teriparatide-induced bone resorption while allowing for continued teriparatide-induced bone formation, resulting in larger increases in hip and spine bone mineral density (BMD) than with either drug alone. We aimed to assess whether administration of denosumab with high dose teriparatide would stimulate larger increases in bone mass than those observed in the DATA study.
METHODS


DATA-HD was an open-label, randomised, controlled phase 4 trial done at Massachusetts General Hospital. Eligible women were postmenopausal women (at least 36 months since last menses or since hysterectomy with a follicle-stimulating hormone concentration of ≥40 U/L) with osteoporosis. Participants were randomly assigned (1:1) to receive teriparatide 20 μg (standard dose) or 40 μg (high dose) daily via subcutaneous injection for 9 months. At 3 months, both groups were started on denosumab 60 mg every 6 months via subcutaneous injection for 12 months. Areal BMD (aBMD) was measured at 0, 3, 9, and 15 months. Treatment was given open label, but outcome assessors were masked. The primary endpoint was percentage change from baseline in spine areal BMD (aBMD) at 15 months. Women who completed at least one study visit after baseline were included in the modified intention-to-treat analysis. Safety was assessed in all randomly assigned participants. This study is registered with ClinicalTrials.gov, number NCT02176382.
FINDINGS


Between Oct 15, 2014, and June 10, 2016, 269 women were assessed for eligibility. 76 participants were randomly assigned to 20 μg teriparatide (n=39) or 40 μg teriparatide (n=37), of whom 69 completed at least one post-baseline visit. At 15 months, mean spine aBMD had increased to a significantly greater extent in the 40 μg group (17·5% [SD 6·0] increase) than the 20 μg group (9·5% [3·2]; difference 8·1%, 95% CI 5·5 to 10·6, p<0·0001). Mean femoral neck aBMD had also increased to a greater extent in the 40 μg group (6·8% [SD 4·1] increase) than the 20 μg group (4·3% [3·7]; difference 2·5%, 0·5 to 4·5, p=0·04), as did mean total hip aBMD (40 μg group, 6·1% [3·4] increase; 20 μg group, 3·9% [2·9] increase; difference 2·2%, 0·6 to 3·8, p<0·0001). 30 (77%) of 39 participants in the 20 μg group and 29 (78%) of 37 participants in the 40 μg group had an adverse event, and seven (18%) and two (5%) patients had serious adverse events. The most frequent adverse events were joint pain (15 [38%]), muscle cramp (15 [38%]), and fatigue (12 [31%]) in the 20 μg group group and fatigue (14 [38%]), nausea (16 [43%]), and joint pain (17 [46%]) in the 40 μg group. No deaths were reported.
INTERPRETATION


Combined treatment with teriparatide 40 μg and denosumab increases spine and hip BMD more than standard combination therapy. This large and rapid increase in bone mass suggest that this high dose regimen might provide a method of restoring skeletal integrity in patients with osteoporosis.
FUNDING


National Institutes of Health and the Dart Foundation.",2019,"At 15 months, mean spine aBMD had increased to a significantly greater extent in the 40 μg group (17·5% [SD 6·0] increase) than the 20 μg group (9·5% [3·2]; difference 8·1%, 95% CI 5·5 to 10·6, p<0·0001).","['76 participants', 'Women who completed at least one study visit after baseline were included in the modified intention-to-treat analysis', 'postmenopausal osteoporosis (DATA-HD', 'Between Oct 15, 2014, and June 10, 2016, 269 women were assessed for eligibility', 'Eligible women were postmenopausal women (at least 36 months since last menses or since hysterectomy with a follicle-stimulating hormone concentration of ≥40 U/L) with osteoporosis', 'patients with osteoporosis']","['denosumab', '40 μg teriparatide', 'teriparatide', 'teriparatide 40 μg and denosumab', 'Combination denosumab and high dose teriparatide', 'teriparatide 20 μg (standard dose) or 40 μg (high dose) daily via subcutaneous injection', 'Denosumab and Teriparatide']","['fatigue', 'serious adverse events', 'hip and spine bone mineral density (BMD', 'Areal BMD (aBMD', 'joint pain', 'percentage change from baseline in spine areal BMD (aBMD', 'spine and hip BMD', 'adverse event', 'muscle cramp', 'Mean femoral neck aBMD', 'mean total hip aBMD', 'mean spine aBMD', 'nausea', 'Safety', 'bone mass']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal Bone Loss'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439339', 'cui_str': 'mU/mL'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",76.0,0.416508,"At 15 months, mean spine aBMD had increased to a significantly greater extent in the 40 μg group (17·5% [SD 6·0] increase) than the 20 μg group (9·5% [3·2]; difference 8·1%, 95% CI 5·5 to 10·6, p<0·0001).","[{'ForeName': 'Joy N', 'Initials': 'JN', 'LastName': 'Tsai', 'Affiliation': 'Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Havard Medical School, Boston, MA, USA. Electronic address: jntsai@mgh.harvard.edu.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital, Havard Medical School, Boston, MA, USA.'}, {'ForeName': 'Natalie L', 'Initials': 'NL', 'LastName': 'David', 'Affiliation': 'Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Havard Medical School, Boston, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Eastell', 'Affiliation': 'Academic Unit of Bone Metabolism, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Benjamin Z', 'Initials': 'BZ', 'LastName': 'Leder', 'Affiliation': 'Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Havard Medical School, Boston, MA, USA.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30255-4']
1822,11143847,Comparison of two radiation dose schedules in post mastectomy carcinoma of the breast.,"In 108 histopathologically proved breast cancer patients, after surgical treatment with modified radical mastectomy, two radiation dose schedules have been compared. Radiation therapy was given on a 60Co teletherapy machine using gent pair technique for chest wall irradiation and direct fields for lymphatic drainage areas. The patients were randomly divided into two groups (Group A and Group B). 54 patients were given external radiotherapy 40 Gy/17 F/3.2 weeks and remaining 54 patients were given 45 Gy/20 F/4 weeks. Results of treatment in Group A versus Group B were as follows; chest wall failure 5/50(10%) versus 3/54 (5.6%), axillary lymphnods failure 3/50(6%) versus 4/54(7%), distant metastasis 16/50(32%) versus 15/54(28%). Radiation reactions were almost similar in both the groups. Skin reactions were most common radiation effects [45/50 (90%) in Group A and 43/54 (79.6% in Group B]. Thus no statistically significant difference in local control and efficacy of these two radiation dose schedules was observed in postmastectomy carcinoma of the breast.",2000,Thus no statistically significant difference in local control and efficacy of these two radiation dose schedules was observed in postmastectomy carcinoma of the breast.,"['post mastectomy carcinoma of the breast', '54 patients were given', '108 histopathologically proved breast cancer patients']","['modified radical mastectomy', 'external radiotherapy', '60Co teletherapy machine', 'Radiation therapy']","['local control and efficacy', 'Skin reactions', 'Radiation reactions']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0024883', 'cui_str': 'Modified Mastectomy'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure (procedure)'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}]",108.0,0.0183823,Thus no statistically significant difference in local control and efficacy of these two radiation dose schedules was observed in postmastectomy carcinoma of the breast.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Goel', 'Affiliation': 'Department of Radiation Oncology, Pt. B.D. Sharma, Post Graduate Institute of Medical Sciences, Rohtak 124001.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Kaushal', 'Affiliation': ''}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Hooda', 'Affiliation': ''}, {'ForeName': 'B P', 'Initials': 'BP', 'LastName': 'Das', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1823,9849033,Double-blind placebo--controlled trial of nandrolone decanoate in postmenopausal osteoporosis.,,1998,,['postmenopausal osteoporosis'],"['nandrolone decanoate', 'placebo']",[],"[{'cui': 'C0029458', 'cui_str': 'Postmenopausal Bone Loss'}]","[{'cui': 'C0068395', 'cui_str': 'nandrolone decanoate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.216082,,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Chhaparwal', 'Affiliation': 'Dept KEM Hospital, Bombay.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Saraf', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1824,31462735,MRD response in relapsed/refractory FL after obinutuzumab plus bendamustine or bendamustine alone in the GADOLIN trial.,"We report assessment of minimal residual disease (MRD) status and its association with outcome in rituximab-refractory follicular lymphoma (FL) in the randomized GADOLIN trial (NCT01059630). Patients received obinutuzumab (G) plus bendamustine (Benda) induction followed by G maintenance, or Benda induction alone. Patients with a clonal marker (t[14;18] translocation and/or immunoglobulin heavy or light chain rearrangement) detected at study screening were assessed for MRD at mid-induction (MI), end of induction (EOI), and every 6-24 months post-EOI/discontinuation by real-time quantitative PCR. At MI, 41/52 (79%) patients receiving G-Benda were MRD-negative vs. 17/36 (47%) patients receiving Benda alone (p = 0.0029). At EOI, 54/63 (86%) patients receiving G-Benda were MRD-negative vs. 30/55 (55%) receiving Benda alone (p = 0.0002). MRD-negative patients at EOI had improved progression-free survival (HR, 0.33, 95% CI, 0.19-0.56, p < 0.0001) and overall survival (HR, 0.39, 95% CI, 0.19-0.78, p = 0.008) vs. MRD-positive patients, and maintained their MRD-negative status for longer if they received G maintenance than if they did not. These results suggest that the addition of G to Benda-based treatment during induction can significantly contribute to the speed and depth of response, and G maintenance in MRD-negative patients potentially delays lymphoma regrowth.",2020,patients receiving Benda alone (p = 0.0029).,"['rituximab-refractory follicular lymphoma (FL', 'Patients with a clonal marker (t[14;18] translocation and/or immunoglobulin heavy or light chain rearrangement']","['obinutuzumab (G) plus bendamustine (Benda) induction followed by G maintenance, or Benda induction alone', 'bendamustine']","['MRD response', 'progression-free survival', 'overall survival']","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}]","[{'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0473059,patients receiving Benda alone (p = 0.0029).,"[{'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Pott', 'Affiliation': 'University Hospital Schleswig-Holstein, Kiel, Germany. c.pott@med2.uni-kiel.de.'}, {'ForeName': 'Laurie H', 'Initials': 'LH', 'LastName': 'Sehn', 'Affiliation': 'British Columbia Cancer Agency and the University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Belada', 'Affiliation': 'Department of Internal Medicine-Haematology, Charles University, Hospital and Faculty of Medicine, Hradec Králové, Czech Republic.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gribben', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hoster', 'Affiliation': 'Hospital of the Ludwig-Maximilians University, Munich, Germany.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Kahl', 'Affiliation': 'Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Kehden', 'Affiliation': 'University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Nicolas-Virelizier', 'Affiliation': 'University of Lyon, Lyon, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Spielewoy', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Guenter', 'Initials': 'G', 'LastName': 'Fingerle-Rowson', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Harbron', 'Affiliation': 'Roche, Welwyn Garden City, UK.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Mundt', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Wassner-Fritsch', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': 'Georgetown University Hospital, Washington, DC, USA.'}]",Leukemia,['10.1038/s41375-019-0559-9']
1825,31442441,A phase I randomized safety study of a single-size silicone rubber diaphragm used with or without a lactic-acid-containing diaphragm gel.,"OBJECTIVES


To evaluate a lactic-acid-containing diaphragm gel (Contragel®) approved outside the United States for use with a silicone rubber diaphragm (Caya®). The study gel is being evaluated as a safer alternative to nonoxynol-9 (N-9) gel, which has been associated with risk of increasing susceptibility to human immunodeficiency virus (HIV).
STUDY DESIGN


This was a Phase I randomized, parallel study evaluating the safety of the novel diaphragm gel versus hydroxyethylcellulose (HEC) universal placebo gel delivered by the study diaphragm for two 7-day test cycles of daily use, without and with intercourse. The primary clinical safety endpoint was treatment emergent adverse events. Mucosal safety endpoints included colposcopic findings, anti-Escherichia coli activity of endocervical and vaginal fluid, immune mediators, Nugent score and ectocervical immune cell density. Endpoints were assessed prior to each test cycle and at day 7 of each test cycle. We compared the two independent groups and also evaluated paired changes from baseline in each gel cohort.
RESULTS


Twenty-three participants used the study diaphragm with the novel gel (n=11) or with HEC (n=12). Use of either gel resulted in few genital AEs and no colposcopic findings. There were no differences in ectocervical histology and lymphocyte density or phenotype between the two cohorts at baseline or after each test cycle. We found no clinically important differences in the anti-microbial (anti Escherichia coli) activity of endocervical or vaginal fluid or concentrations of genital immune mediators (e.g. anti-inflammatory secretory leukocyte protease inhibitor (SLPI) or pro-inflammatory mediator RANTES) between the two gel cohorts at any visit. There were no important paired changes from baseline among participants using either gel in Nugent score, ectocervical histology or anti-microbial activity of genital secretions.
CONCLUSIONS


We found no clinically significant differences in clinical and mucosal safety endpoints between the two cohorts. The mucosal safety profiles of the study gel and HEC placebo gel were similar.
IMPLICATIONS


Our data demonstrate no clinically important differences between the safety profiles of the lactic-acid-containing diaphragm gel versus HEC placebo gel when used with the study diaphragm. N-9 can no longer be used with contraceptive diaphragms in high HIV prevalence regions. Although larger studies are needed, the novel gel appears safe for use with the study diaphragm, which is the first over-the-counter, non-hormonal, diaphragm.",2019,"There were no important paired changes from baseline among participants using either gel in Nugent score, ectocervical histology or anti-microbial activity of genital secretions.
",['Twenty-three participants used the study diaphragm with the novel gel (n=11) or with HEC (n=12'],"['HEC placebo gel', 'diaphragm gel versus HEC placebo gel', 'silicone rubber diaphragm (Caya®', 'N-9', 'lactic-acid-containing diaphragm gel (Contragel®', 'nonoxynol-9 (N-9) gel', 'single-size silicone rubber diaphragm used with or without a lactic-acid-containing diaphragm gel', 'novel diaphragm gel versus hydroxyethylcellulose (HEC) universal placebo gel']","['Nugent score, ectocervical histology or anti-microbial activity of genital secretions', 'ectocervical histology and lymphocyte density or phenotype', 'emergent adverse events', 'clinical and mucosal safety endpoints', 'colposcopic findings, anti-Escherichia coli activity of endocervical and vaginal fluid, immune mediators, Nugent score and ectocervical immune cell density', 'mucosal safety profiles']","[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0318598', 'cui_str': 'Human enteric calicivirus (organism)'}]","[{'cui': 'C0318598', 'cui_str': 'Human enteric calicivirus (organism)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0037110', 'cui_str': 'Silicone Rubber'}, {'cui': 'C0064582', 'cui_str': 'Lactic acid'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0132776', 'cui_str': 'Nonoxynol-9'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0856484', 'cui_str': 'Diaphragm use'}, {'cui': 'C0063131', 'cui_str': 'hydroxyethyl cellulose'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C4521006', 'cui_str': 'Endocervical'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0162339', 'cui_str': 'Cell Density'}]",23.0,0.0886453,"There were no important paired changes from baseline among participants using either gel in Nugent score, ectocervical histology or anti-microbial activity of genital secretions.
","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Thurman', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, 601 Colley Ave, Norfolk, VA, USA 23507. Electronic address: thurmaar@evms.edu.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Cunningham', 'Affiliation': 'Healthcare Delivery Science Program, Healthcare Analytics Program, Eastern Virginia Medical School, 651 Colley Ave, Norfolk, VA, USA 23507.'}, {'ForeName': 'Raina', 'Initials': 'R', 'LastName': 'Fichorova', 'Affiliation': ""Laboratory of Genital Tract Biology, Brigham and Women's Hospital, Harvard University, 221 Longwood Ave., Boston, MA, 02115.""}, {'ForeName': 'Betsy C', 'Initials': 'BC', 'LastName': 'Herold', 'Affiliation': 'Albert Einstein College of Medicine, 1300 Morris Park Avenue, Bronx, NY 10461.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Hillier', 'Affiliation': 'Magee-Womens Research Institute and the University of Pittsburgh, 204 Craft Ave., Pittsburgh, PA 15213.'}, {'ForeName': 'Neelima', 'Initials': 'N', 'LastName': 'Chandra', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, 601 Colley Ave, Norfolk, VA, USA 23507.'}, {'ForeName': 'Gustavo F', 'Initials': 'GF', 'LastName': 'Doncel', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, 601 Colley Ave, Norfolk, VA, USA 23507; CONRAD, Eastern Virginia Medical School, 1911 North Fort Myer Drive, Arlington, Virginia, USA 22209.'}]",Contraception,['10.1016/j.contraception.2019.06.004']
1826,31454802,Four-Week Omega-3 Supplementation in Carriers of the Prosteatotic PNPLA3 p.I148M Genetic Variant: An Open-Label Study.,"BACKGROUND/AIMS


The PNPLA3 loss-of-function variant p.I148M is a strong genetic determinant of nonalcoholic fatty liver disease. The PNPLA3 protein functions as an intracellular lipase in the liver, with a greater activity on unsaturated fatty acids. This study aimed to determine whether short-term supplementation with omega-3 fatty acids impacts hepatic steatosis differently in PNPLA3 p.148I wild-type individuals as compared to homozygous carriers of the PNPLA3 p.148M variant.
METHODS


Twenty subjects with hepatic steatosis (50% women, age 18-77 years) were included. Ten subjects homozygous for the PNPLA3 148M variant were matched to 10 wild-type individuals. The subjects received 4 g omega-3 fatty acids (1,840 mg eicosapentaenoic acid and 1,520 mg docosahexaenoic acid) a day for 4 weeks. Transient elastography with a controlled attenuation parameter (CAP) was used to quantify liver fat before and after the intervention. Body composition, fibrosis, liver function tests, serum free fatty acids (FFA) and glucose markers were compared.
RESULTS


Patients homozygous for the PNPLA3 p.148M variant (risk group) demonstrated no significant changes in CAP compared to baseline (284 ± 55 vs. 287 ± 65 dB/m) as did the control group (256 ± 56 vs. 262 ± 55 dB/m). While serum liver enzyme activities remained unchanged in both groups, the risk group displayed significantly (p = 0.02) lower baseline FFA concentrations (334.5 [range 281.0-431.0] vs. 564.5 [range 509.0-682.0] μmol/L), which markedly increased by 9.1% after the intervention. In contrast, FFA concentrations decreased significantly (p = 0.01) by 28.3% in the wild-type group.
CONCLUSIONS


Short-term omega-3 fatty acid supplementation did not significantly alter hepatic steatosis. The nutrigenomic and metabolic effects of omega-3 fatty acids should be investigated further in carriers of the PNPLA3 148M risk variant.",2019,"While serum liver enzyme activities remained unchanged in both groups, the risk group displayed significantly (p = 0.02) lower baseline FFA concentrations (334.5 [range 281.0-431.0] vs. 564.5 [range 509.0-682.0] μmol/L), which markedly increased by 9.1% after the intervention.","['Ten subjects homozygous for the PNPLA3 148M variant were matched to 10 wild-type individuals', 'I148M Genetic Variant', 'Twenty subjects with hepatic steatosis (50% women, age 18-77 years', 'carriers of the PNPLA3 148M risk variant', 'PNPLA3 p.148I wild-type individuals as compared to homozygous carriers of the PNPLA3 p.148M variant']","['4\xa0g omega-3 fatty acids (1,840 mg eicosapentaenoic acid and 1,520 mg docosahexaenoic acid', 'Short-term omega-3 fatty acid supplementation', 'omega-3 fatty acids', 'Transient elastography with a controlled attenuation parameter (CAP']","['baseline FFA concentrations', 'FFA concentrations', 'Body composition, fibrosis, liver function tests, serum free fatty acids (FFA) and glucose markers', 'hepatic steatosis', 'CAP', 'serum liver enzyme activities']","[{'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation (product)'}, {'cui': 'C2748260', 'cui_str': 'Transient elastography'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0023901', 'cui_str': 'Liver Function Tests'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0373606', 'cui_str': 'Free fatty acids measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",20.0,0.0202791,"While serum liver enzyme activities remained unchanged in both groups, the risk group displayed significantly (p = 0.02) lower baseline FFA concentrations (334.5 [range 281.0-431.0] vs. 564.5 [range 509.0-682.0] μmol/L), which markedly increased by 9.1% after the intervention.","[{'ForeName': 'Clara-Sophie', 'Initials': 'CS', 'LastName': 'Kuttner', 'Affiliation': 'Department of Medicine II, Saarland University Medical Center, Saarland University, Homburg, Germany.'}, {'ForeName': 'Rosellina', 'Initials': 'R', 'LastName': 'Mancina', 'Affiliation': 'Department of Molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Wagenpfeil', 'Affiliation': 'Institute of Medical Biometry, Epidemiology and Medical Informatics, Saarland University, Homburg, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lammert', 'Affiliation': 'Department of Medicine II, Saarland University Medical Center, Saarland University, Homburg, Germany, frank.lammert@uks.eu.'}, {'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Stokes', 'Affiliation': 'Department of Medicine II, Saarland University Medical Center, Saarland University, Homburg, Germany.'}]",Lifestyle genomics,['10.1159/000502008']
1827,31425966,Induction chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: long-term results of a phase III multicentre randomised controlled trial.,"BACKGROUND


Initial 3-year results from our clinical trial in locoregionally advanced nasopharyngeal carcinoma (NPC) patients showed that induction chemotherapy (IC) with cisplatin and fluorouracil resulted in improved disease-free survival (DFS) with a marginally significant effect on distant metastasis-free survival (DMFS), but the effect of IC on locoregional relapse-free survival and overall survival (OS) did not differ significantly. Here, we present 5-year follow-up results.
PATIENTS AND METHODS


Our trial was a randomised, open-label phase III trial comparing IC followed by concurrent chemoradiotherapy (CCRT) versus CCRT alone in patients with stage III-IVB (except T3N0-1) NPC. The IC followed by CCRT group received cisplatin (80 mg/m 2  d1) and fluorouracil (800 mg/m 2  d1-5) every 3 weeks for two cycles before CCRT. Both groups were treated with 80 mg/m 2  cisplatin every 3 weeks concurrently with radiotherapy. The primary end-points were DFS and DMFS. We did efficacy analyses in the 476 randomised patients (intention-to-treat population).
RESULTS


After a median follow-up of 82.6 months, the 5-year DFS rate was 73.4% (95% confidence interval [CI] 67.7-79.1) in the IC followed by CCRT group and 63.1% (95% CI 56.8-69.4) in the CCRT alone group (p = 0.007). The 5-year DMFS rate was also significantly higher in the IC followed by CCRT group (82.8%, 95% CI 77.9-87.7) than in the CCRT alone group (73.1%, 95% CI 67.2-79.0, p = 0.014). Our updated analysis revealed an OS benefit of IC: the 5-year OS rate was 80.8% in the IC followed by CCRT group versus 76.8% in the CCRT alone group (p = 0.040). The proportion of patients with eye damage was significantly higher in the CCRT alone group than the IC followed by CCRT group (16.4% [39/238] versus 9.7% [23/238], p = 0.029).
CONCLUSION


IC followed by CCRT provides long-term DFS, DMFS and OS benefits compared with CCRT alone in locoregionally advanced NPC and, therefore, can be recommended for these patients.",2019,"The proportion of patients with eye damage was significantly higher in the CCRT alone group than the IC followed by CCRT group (16.4% [39/238] versus 9.7% [23/238], p = 0.029).
","['locoregionally advanced nasopharyngeal carcinoma (NPC) patients', 'locoregionally advanced nasopharyngeal carcinoma', '476 randomised patients (intention-to-treat population', 'patients with stage III-IVB (except T3N0-1) NPC']","['Induction chemotherapy', 'chemoradiotherapy versus concurrent chemoradiotherapy alone', 'induction chemotherapy (IC) with cisplatin and fluorouracil', '80\xa0mg/m 2  cisplatin', 'concurrent chemoradiotherapy (CCRT) versus CCRT', 'radiotherapy', 'cisplatin', 'CCRT', 'fluorouracil']","['5-year DMFS rate', '5-year OS rate', '5-year DFS rate', 'distant metastasis-free survival (DMFS', 'DFS and DMFS', 'disease-free survival (DFS', 'proportion of patients with eye damage', 'locoregional relapse-free survival\xa0and overall survival (OS']","[{'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}]","[{'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.259479,"The proportion of patients with eye damage was significantly higher in the CCRT alone group than the IC followed by CCRT group (16.4% [39/238] versus 9.7% [23/238], p = 0.029).
","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Su-Mei', 'Initials': 'SM', 'LastName': 'Cao', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Cancer Prevention Center, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yi-Jun', 'Initials': 'YJ', 'LastName': 'Hua', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Pei-Yu', 'Initials': 'PY', 'LastName': 'Huang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Xiao-Long', 'Initials': 'XL', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'You', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'You-Ping', 'Initials': 'YP', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yu-Long', 'Initials': 'YL', 'LastName': 'Xie', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Zhi-Qiang', 'Initials': 'ZQ', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Hai-Qiang', 'Initials': 'HQ', 'LastName': 'Mai', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Qiu-Yan', 'Initials': 'QY', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Lin-Quan', 'Initials': 'LQ', 'LastName': 'Tang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Hao-Yuan', 'Initials': 'HY', 'LastName': 'Mo', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ka-Jia', 'Initials': 'KJ', 'LastName': 'Cao', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Chao-Nan', 'Initials': 'CN', 'LastName': 'Qian', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yan-Qun', 'Initials': 'YQ', 'LastName': 'Xiang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Xiu-Ping', 'Initials': 'XP', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, Cancer Center of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Zhi-Xiong', 'Initials': 'ZX', 'LastName': 'Lin', 'Affiliation': 'Department of Radiation Oncology, Cancer Center of Shantou University Medical College, Shantou, China.'}, {'ForeName': 'Wei-Xiong', 'Initials': 'WX', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, Guangdong General Hospital, Guangzhou, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Cancer Prevention Center, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ji-Bin', 'Initials': 'JB', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Clinical Trial Center, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ling', 'Affiliation': 'Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China. Electronic address: guoxiang@sysucc.org.cn.'}, {'ForeName': 'Ming-Huang', 'Initials': 'MH', 'LastName': 'Hong', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Clinical Trial Center, Sun Yat-sen University Cancer Center, Guangzhou, China. Electronic address: hongmh@sysucc.org.cn.'}, {'ForeName': 'Ming-Yuan', 'Initials': 'MY', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China. Electronic address: chenmy@sysucc.org.cn.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.07.007']
1828,31371228,"Adjuvant hyperthermic intraperitoneal chemotherapy in patients with locally advanced colon cancer (COLOPEC): a multicentre, open-label, randomised trial.","BACKGROUND


Nearly a quarter of patients with locally advanced (T4 stage) or perforated colon cancer are at risk of developing peritoneal metastases, often without curative treatment options. We aimed to determine the efficacy of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with locally advanced colon cancer.
METHODS


This multicentre, open-label trial was done in nine hospitals that specialised in HIPEC in the Netherlands. Patients with clinical or pathological T4N0-2M0-stage tumours or perforated colon cancer were randomly assigned (1:1), with a web-based randomisation application, before resection of the primary tumour, to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy (experimental group) or to adjuvant systemic chemotherapy alone (control group). Patients were stratified by tumour characteristic (T4 or perforation), age (<65 years or ≥65 years), and surgical approach of the primary tumour resection (laparoscopic or open). Key eligibility criteria included age between 18 and 75 years, adequate clinical condition for HIPEC, and intention to start adjuvant systemic chemotherapy. Patients with metastatic disease were ineligible. Adjuvant HIPEC consisted of fluorouracil (400 mg/m 2 ) and leucovorin (20 mg/m 2 ) delivered intravenously followed by intraperitoneal delivery of oxaliplatin (460 mg/m 2 ) for 30 min at 42°C, delivered simultaneously or within 5-8 weeks after primary tumour resection. In all patients without evidence of recurrent disease at 18 months, a diagnostic laparoscopy was done. The primary endpoint was peritoneal metastasis free-survival at 18 months, measured in the intention-to-treat population, with the Kaplan-Meier method. Adverse events were assessed in all patients who received assigned treatment. This study is registered with ClinicalTrials.gov, number NCT02231086.
FINDINGS


Between April 1, 2015, and Feb 20, 2017, 204 patients were randomly assigned to treatment (102 in each group). In the HIPEC group, two patients withdrew consent after randomisation. In this group, 19 (19%) of 100 patients were diagnosed with peritoneal metastases: nine (47%) during surgical exploration preceding intentional adjuvant HIPEC, eight (42%) during routine follow-up, and two (11%) during diagnostic laparoscopy at 18-months. In the control group, 23 (23%) of 102 patients were diagnosed with peritoneal metastases, of whom seven (30%) were diagnosed by laparoscopy at 18-months and 16 during regular follow-up (therefore making them ineligible for diagnostic laparoscopy). In the intention-to-treat analysis (n=202), there was no difference in peritoneal-free survival at 18-months (80·9% [95% CI 73·3-88·5] for the experimental group vs 76·2% [68·0-84·4] for the control group, log-rank one-sided p=0·28). 12 (14%) of 87 patients who received adjuvant HIPEC developed postoperative complications and one (1%) encapsulating peritoneal sclerosis.
INTERPRETATION


In patients with T4 or perforated colon cancer, treatment with adjuvant HIPEC with oxaliplatin did not improve peritoneal metastasis-free survival at 18 months. Routine use of adjuvant HIPEC is not advocated on the basis of this trial.
FUNDING


Organization for Health Research and Development and the Dutch Cancer Society.",2019,"In the intention-to-treat analysis (n=202), there was no difference in peritoneal-free survival at 18-months (80·9% [95% CI 73·3-88·5] for the experimental group vs 76·2% [68·0-84·4] for the control group, log-rank one-sided p=0·28).","['patients with locally advanced colon cancer (COLOPEC', 'nine hospitals that specialised in HIPEC in the Netherlands', 'patients with locally advanced (T4 stage) or perforated colon cancer', 'Patients with clinical or pathological T4N0-2M0-stage tumours or perforated colon cancer', '204 patients', 'Between April 1, 2015, and Feb 20, 2017', '100 patients were diagnosed with peritoneal metastases: nine (47%) during surgical exploration preceding intentional adjuvant HIPEC, eight (42%) during routine follow-up, and two (11%) during diagnostic laparoscopy at 18-months', '102 patients were diagnosed with peritoneal metastases, of whom seven (30%) were diagnosed by laparoscopy at 18-months and 16 during regular follow-up (therefore making them ineligible for diagnostic laparoscopy', 'patients with locally advanced colon cancer', 'Key eligibility criteria included age between 18 and 75 years, adequate clinical condition for HIPEC, and intention to start adjuvant systemic chemotherapy', 'patients with T4 or perforated colon cancer', 'Patients with metastatic disease were ineligible', 'Patients were stratified by tumour characteristic (T4 or perforation), age (<65 years or ≥65 years), and surgical approach of the primary tumour resection (laparoscopic or open']","['Adjuvant hyperthermic intraperitoneal chemotherapy', 'adjuvant HIPEC with oxaliplatin', 'leucovorin', 'oxaliplatin', 'adjuvant HIPEC followed by routine adjuvant systemic chemotherapy (experimental group) or to adjuvant systemic chemotherapy alone (control group', 'adjuvant HIPEC', 'adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC', 'fluorouracil']","['peritoneal metastasis free-survival', 'peritoneal metastasis-free survival', 'Adverse events', 'peritoneal-free survival', 'postoperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1704211', 'cui_str': 'Specialized'}, {'cui': 'C0475751', 'cui_str': 'Tumor stage T4'}, {'cui': 'C0347646', 'cui_str': 'Perforation of colon (disorder)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0346989', 'cui_str': 'Secondary malignant peritoneal deposit'}, {'cui': 'C0184899', 'cui_str': 'Exploratory incision (procedure)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1880304', 'cui_str': 'Diagnostic laparoscopy (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}, {'cui': 'C0449446', 'cui_str': 'Surgical approach (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0346989', 'cui_str': 'Secondary malignant peritoneal deposit'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",204.0,0.281255,"In the intention-to-treat analysis (n=202), there was no difference in peritoneal-free survival at 18-months (80·9% [95% CI 73·3-88·5] for the experimental group vs 76·2% [68·0-84·4] for the control group, log-rank one-sided p=0·28).","[{'ForeName': 'Charlotte E L', 'Initials': 'CEL', 'LastName': 'Klaver', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Wisselink', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Cornelis J A', 'Initials': 'CJA', 'LastName': 'Punt', 'Affiliation': 'Department of Oncology, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Petur', 'Initials': 'P', 'LastName': 'Snaebjornsson', 'Affiliation': 'Department of Pathology, Antoni van Leeuwenhoek Hospital-Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Crezee', 'Affiliation': 'Department of Radiation Oncology, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Arend G J', 'Initials': 'AGJ', 'LastName': 'Aalbers', 'Affiliation': 'Department of Surgery, Antoni van Leeuwenhoek Hospital-Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Brandt', 'Affiliation': 'Department of Surgery, Erasmus Medical centre at Daniel den Hoed, Rotterdam, Netherlands.'}, {'ForeName': 'Andre J A', 'Initials': 'AJA', 'LastName': 'Bremers', 'Affiliation': 'Department of Surgery, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Jacobus W A', 'Initials': 'JWA', 'LastName': 'Burger', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, Netherlands.'}, {'ForeName': 'Hans F J', 'Initials': 'HFJ', 'LastName': 'Fabry', 'Affiliation': 'Department of Surgery, Bravis Hospital, Roosendaal, Netherlands.'}, {'ForeName': 'Floris', 'Initials': 'F', 'LastName': 'Ferenschild', 'Affiliation': 'Department of Surgery, Maasziekenhuis Pantein, Beugen, Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Festen', 'Affiliation': 'Department of Surgery, Onze Lieve Vrouwen Gasthuis, Amsterdam, Netherlands.'}, {'ForeName': 'Wilhelmina M U', 'Initials': 'WMU', 'LastName': 'van Grevenstein', 'Affiliation': 'Department of Surgery, University Medical Centre Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Patrick H J', 'Initials': 'PHJ', 'LastName': 'Hemmer', 'Affiliation': 'Department of Surgery, Universitair Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Ignace H J T', 'Initials': 'IHJT', 'LastName': 'de Hingh', 'Affiliation': 'Department of Surgery, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Niels F M', 'Initials': 'NFM', 'LastName': 'Kok', 'Affiliation': 'Department of Surgery, Antoni van Leeuwenhoek Hospital-Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Gijsbert D', 'Initials': 'GD', 'LastName': 'Musters', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Schoonderwoerd', 'Affiliation': 'Department of Surgery, Bernhoven, Uden, Netherlands.'}, {'ForeName': 'Jurriaan B', 'Initials': 'JB', 'LastName': 'Tuynman', 'Affiliation': 'Department of Surgery, Amsterdam UMC, Free University, Cancer Centre Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Anthony W H', 'Initials': 'AWH', 'LastName': 'van de Ven', 'Affiliation': 'Department of Surgery, Flevo hospital, Almere, Netherlands.'}, {'ForeName': 'Henderik L', 'Initials': 'HL', 'LastName': 'van Westreenen', 'Affiliation': 'Department of Surgery, Isala Hospital, Zwolle, Netherlands.'}, {'ForeName': 'Marinus J', 'Initials': 'MJ', 'LastName': 'Wiezer', 'Affiliation': 'Department of Surgery, St Antonius Hospital, CM Nieuwegein, Netherlands.'}, {'ForeName': 'David D E', 'Initials': 'DDE', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Surgery, Elisabeth-Tweesteden Hospital, Tilburg, Netherlands.'}, {'ForeName': 'Annette A', 'Initials': 'AA', 'LastName': 'van Zweeden', 'Affiliation': 'Department of Internal Medicine, Amstelland Hospital, Amstelveen, Netherlands.'}, {'ForeName': 'Marcel G W', 'Initials': 'MGW', 'LastName': 'Dijkgraaf', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Tanis', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, Netherlands. Electronic address: p.j.tanis@amsterdamumc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30239-0']
1829,11482162,"Ginger, fat and fibrinolysis.",Administration of 50 gm of fat to 30 healthy adult volunteers decreased fibrinolytic activity from a mean of 64.20 +/- 5.31 to 52.10 +/- 3.20 units (P < 0.001). Supplementation of 5 gm of ginger powder with fatty meal not only prevented the fall in fibrinolytic activity but actually increased it significantly (P < 0.001). This fibrinolytic enhancing property is a further addition to the therapeutic potential of ginger.,2001,Administration of 50 gm of fat to 30 healthy adult volunteers decreased fibrinolytic activity from a mean of 64.20 +/-,['30 healthy adult volunteers'],['ginger powder with fatty meal'],"['fall in fibrinolytic activity', 'fibrinolytic activity', 'Ginger, fat and fibrinolysis']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C1879327', 'cui_str': 'Zingiber officinale'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1879327', 'cui_str': 'Zingiber officinale'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1305868', 'cui_str': 'Fibrinolysis'}]",30.0,0.0211293,Administration of 50 gm of fat to 30 healthy adult volunteers decreased fibrinolytic activity from a mean of 64.20 +/-,"[{'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Verma', 'Affiliation': 'Department of Medicine and Indigenous Drug Research Centre, R.N.T. Medical College, Udaipur-313 001.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bordia', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1830,31392790,Exercise-induced hypoalgesia in young adult females with long-standing patellofemoral pain - A randomized crossover study.,"BACKGROUND


Patellofemoral pain (PFP) is a common knee pain condition where hip and knee exercises help improve treatment outcomes. This study compared the acute effect of hip versus knee exercises on anti-nociceptive and pro-nociceptive mechanisms in young females with long-standing PFP.
METHODS


In this randomized cross-over study, 29 females with PFP performed hip and knee exercises in randomized order during a single day. Pressure pain thresholds (PPTs) were assessed by handheld pressure algometry at the patella, the tibialis anterior muscle, and the contralateral elbow. Cuff pressure algometry at the lower legs was used to assess pain detection threshold (cPDT) and tolerance (cPTT) as well as conditioned pain modulation (CPM: change in cPDT during contralateral cuff pain conditioning) and temporal summation of pain (TSP: ten painful cuff stimulations assessed on a visual analogue scale [VAS]).
RESULTS


PPTs at the tibialis anterior muscle but not at the patella increased compared with baseline following both exercises (p < .002). Compared with baseline, the cPDTs and cPTTs increased after both types of exercises (p < .001). The cPTTs increased more after knee compared to hip exercises (p < .007). VAS scores for TSP were increased following hip exercises (p < .001) although the rate of VAS increase over repeated stimulations was not significantly affected by exercises. The CPM-effect was reduced after both types of exercises (p < .001).
CONCLUSION


A general hypoalgesic response to slowly increasing pressure stimuli was observed following both hip and knee exercises as well as decreased conditioned pain modulation, potentially indicating an attenuated ability from exercise to inhibit pain.",2019,"Compared with baseline, the cPDTs and cPTTs increased after both types of exercises (p < .001).","['young adult females with long-standing patellofemoral pain ', 'young females with long-standing PFP', '29 females with']","['Exercise-induced hypoalgesia', 'PFP performed hip and knee exercises', 'hip versus knee exercises']","['rate of VAS increase', 'VAS scores for TSP', 'Pressure pain thresholds (PPTs', 'CPM-effect', 'Cuff pressure algometry', 'pain detection threshold (cPDT) and tolerance (cPTT', 'conditioned pain modulation']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0085625', 'cui_str': 'Hypoalgesia (finding)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0454364', 'cui_str': 'Knee exercises (regime/therapy)'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1533179', 'cui_str': 'Tsp'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0392412', 'cui_str': 'cpm'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",,0.0443999,"Compared with baseline, the cPDTs and cPTTs increased after both types of exercises (p < .001).","[{'ForeName': 'Christian L', 'Initials': 'CL', 'LastName': 'Straszek', 'Affiliation': 'Center for General Practice at Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Rathleff', 'Affiliation': 'Center for General Practice at Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Graven-Nielsen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Kristian K', 'Initials': 'KK', 'LastName': 'Petersen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Ewa M', 'Initials': 'EM', 'LastName': 'Roos', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Sinead', 'Initials': 'S', 'LastName': 'Holden', 'Affiliation': 'Center for General Practice at Aalborg University, Aalborg, Denmark.'}]","European journal of pain (London, England)",['10.1002/ejp.1452']
1831,31686407,An Update on Vitamin D and Disease Activity in Multiple Sclerosis.,"Vitamin D and its main active metabolite 1,25-dihydroxyvitamin D serve a crucial role in maintenance of a healthy calcium metabolism, yet have additional roles in immune and central nervous system cell homeostasis. Serum levels of 25-hydroxyvitamin D are a biomarker of future disease activity in patients with early relapsing-remitting multiple sclerosis (RRMS), and vitamin D supplementation in patients with low circulating 25-dihydroxyvitamin D levels has been anticipated as a potential efficacious treatment strategy. The results of the first large randomized clinical trials (RCTs), the SOLAR and CHOLINE studies, have now been published. The SOLAR study compared 14,000 IU of vitamin D 3  (cholecalciferol) per day with placebo for 48 weeks in 232 randomized patients, whereas CHOLINE compared vitamin D 3  100,000 IU every other week with placebo for 96 weeks in 129 randomized patients. All patients in both studies also used interferon-β-1a. None of the studies met their primary endpoints, which were no evidence of disease activity (NEDA-3) at 48 weeks in SOLAR and annualized relapse rate at 96 weeks in CHOLINE. Both studies did, however, suggest modest effects on secondary endpoints. Thus, vitamin D reduced the number of new or enlarging lesions and new T2 lesions in SOLAR, and the annualized relapse rate and number of new T1 lesions, volume of hypointense T1 lesions, and disability progression in the 90 patients who completed 96 weeks' follow-up in CHOLINE. We conclude that none of the RCTs on vitamin supplementation in MS have met their primary clinical endpoint in the intention to treat cohorts. This contrasts the observation studies, where each 25 nmol/l increase in 25-hydroxyvitamin D levels were associated with 14-34% reduced relapse risk and 15-50% reduced risk of new lesions on magnetic resonnance imaging. This discrepancy may have several explanations, including confounding and reverse causality in the observational studies. The power calculations of the RCTs have been based on the observational studies, and the RCTs may have been underpowered to detect less prominent yet important effects of vitamin D supplementation. Although the effect of vitamin D supplementation is uncertain and less pronounced than suggested by observational studies, current evidence still support that people with MS should avoid vitamin D insufficiency, and preferentially aim for vitamin D levels around 100 nmol/L or somewhat higher.",2019,"None of the studies met their primary endpoints, which were no evidence of disease activity (NEDA-3) at 48 weeks in SOLAR and annualized relapse rate at 96 weeks in CHOLINE.","['Multiple Sclerosis', 'patients with early relapsing-remitting multiple sclerosis (RRMS']","['interferon-β-1a', 'vitamin D supplementation', 'vitamin D 3  (cholecalciferol) per day with placebo', 'placebo', 'Vitamin D']","['number of new or enlarging lesions and new T2 lesions in SOLAR, and the annualized relapse rate and number of new T1 lesions, volume of hypointense T1 lesions, and disability progression', 'Serum levels of 25-hydroxyvitamin D', '25-hydroxyvitamin D levels', 'disease activity (NEDA-3', 'annualized relapse rate']","[{'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0751967', 'cui_str': 'Multiple Sclerosis, Relapsing-Remitting'}]","[{'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",232.0,0.178116,"None of the studies met their primary endpoints, which were no evidence of disease activity (NEDA-3) at 48 weeks in SOLAR and annualized relapse rate at 96 weeks in CHOLINE.","[{'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Smolders', 'Affiliation': 'Department of Neurology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'Øivind', 'Initials': 'Ø', 'LastName': 'Torkildsen', 'Affiliation': 'Department of Neurology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Camu', 'Affiliation': 'Centre de Référence SLA, CHU Gui de Chauliac et Univ Montpellier, Montpellier, France.'}, {'ForeName': 'Trygve', 'Initials': 'T', 'LastName': 'Holmøy', 'Affiliation': 'Department of Neurology, Akershus University Hospital, Box 1000, 1478, Lørenskog, Norway. trygve.holmoy@medisin.uio.no.'}]",CNS drugs,['10.1007/s40263-019-00674-8']
1832,31227284,Impact of elagolix on work loss due to endometriosis-associated pain: estimates based on the results of two phase III clinical trials.,"OBJECTIVE


To estimate the impact of elagolix on work loss due to endometriosis-associated pain.
DESIGN


Post hoc analysis of data from the Elaris I and II clinical trials.
SETTING


Not applicable.
PATIENT(S)


Employed women ages 18-49 years with moderate-to-severe endometriosis-associated pain.
INTERVENTION(S)


In the two trials, participants were randomized to 6 months of treatment with placebo, elagolix 150 mg once a day, or elagolix 200 mg twice a day.
MAIN OUTCOME MEASURE(S)


Data on planned work hours, presenteeism, absenteeism, and total work loss (absenteeism + presenteeism) at baseline and month 3 were collected using the Health-Related Productivity Questionnaire.
RESULT(S)


This analysis included employed participants from EM-I (n = 672) and EM-II (n = 626). Between baseline and month 3, compared with participants treated with placebo, participants treated with elagolix 150 mg once a day gained > 2 hours total work/week (EM-I, 2.20 ± 1.03; EM-II, 2.65 ± 1.14). Participants treated with 200 mg twice a day gained > 4 hours total work/week (EM-I, 4.91 ± 1.04; EM-II, 4.64 ± 1.14). Both absenteeism and presenteeism were reduced, although most of the gain was due to reduced presenteeism. Estimated cost savings after 6 months of treatment with elagolix were > $1,500 U.S. at 150 mg once a day and > $3,300 U.S. at 200 mg twice a day.
CONCLUSION(S)


Compared with placebo, treating moderate-to-severe endometriosis-associated pain with elagolix reduced absenteeism and improved productivity in employed women, which should result in cost savings.
CLINICAL TRIAL NUMBER(S)


NCT01620528 (EM-I) and NCT01931670 (EM-II).",2019,"Both absenteeism and presenteeism were reduced, although most of the gain was due to reduced presenteeism.","['endometriosis-associated pain', 'participants from EM-I (n = 672) and EM-II (n = 626', '\n\n\nEmployed women ages 18-49\xa0years with moderate-to-severe endometriosis-associated pain']","['placebo, elagolix 150\xa0mg once a day, or elagolix 200\xa0mg twice a day', 'elagolix', 'placebo']","['Estimated cost savings', 'planned work hours, presenteeism, absenteeism, and total work loss (absenteeism + presenteeism']","[{'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4704599', 'cui_str': 'elagolix 150 MG [Orilissa]'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C4704604', 'cui_str': 'elagolix 200 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C2714632', 'cui_str': 'elagolix'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0085550', 'cui_str': 'Saving, Cost'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.219069,"Both absenteeism and presenteeism were reduced, although most of the gain was due to reduced presenteeism.","[{'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Pokrzywinski', 'Affiliation': 'Evidera, Bethesda, Maryland. Electronic address: robin.pokrzywinski@evidera.com.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Soliman', 'Affiliation': 'AbbVie, North Chicago, Illinois.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Evidera, Bethesda, Maryland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Snabes', 'Affiliation': 'AbbVie, North Chicago, Illinois.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Diamond', 'Affiliation': 'Augusta University, Augusta, Georgia.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Surrey', 'Affiliation': 'Colorado Center for Reproductive Medicine, Lone Tree, Colorado.'}, {'ForeName': 'Karin S', 'Initials': 'KS', 'LastName': 'Coyne', 'Affiliation': 'Evidera, Bethesda, Maryland.'}]",Fertility and sterility,['10.1016/j.fertnstert.2019.04.031']
1833,31415787,A long-term evaluation of experimental potassium oxalate concentrations on dentin hypersensitivity reduction: A triple-blind randomized clinical trial.,"OBJECTIVE


The aim of this split-mouth, triple-blind, randomized clinical trial was to evaluate the long-term clinical efficacy of experimental potassium oxalate concentration (10%) in relieving dentin hypersensitivity (DH), after a four-session application protocol.
METHODS


Potassium oxalate gels with different concentrations (5 and 10%) were randomly assigned to half of the 31 patients from the sample in a split-mouth design. The desensitizers were applied following a four-session protocol, one session every 48 h. The primary outcome was the assessment of pain level with the visual analog scale (VAS, 0-10), at baseline, immediately after each desensitizing session, and also after the seventh day and along 1-,3-, 6-, 9- and 12-months follow-ups. Statistical analyses were performed using Friedman repeated measures and Wilcoxon signed rank tests (α = 0.05).
RESULTS


For both groups, the minimum of three sessions were required for the achievement of lower DH levels. Regardless of the concentration, the desensitizing effect was maintained all the way to the end of the 6-month follow-up. The 10%-potassium oxalate group was more effective for both 9 and 12-months follow-up periods (p < 0.001). No complications and adverse effects were observed.
CONCLUSIONS


When a four-session protocol is applied, both concentrations of potassium oxalate (5 and 10%) proved to be effective on DH reduction for up to six months. However, the higher concentration promoted better long-term results.
CLINICAL SIGNIFICANCE


The DH is an increasing condition in clinical practice, which affects the patient's life quality. This study provides primary clinical evidence, suggesting that multiple application sessions and higher concentrations of potassium oxalate may result in maintenance of the desensitizing effect for more extended periods. Trial registered under number: ClinicalTrials.gov NCT03083496.",2019,"No complications and adverse effects were observed.
","['dentin hypersensitivity reduction', 'Potassium oxalate gels with different concentrations (5 and 10%) were randomly assigned to half of the 31 patients from the sample in a split-mouth design']",[],"['relieving dentin hypersensitivity (DH', 'DH reduction', 'assessment of pain level with the visual analog scale (VAS, 0-10', 'complications and adverse effects']","[{'cui': 'C0011432', 'cui_str': 'Tooth Sensitivity'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0032837', 'cui_str': 'Potassium Oxalate'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}]",[],"[{'cui': 'C1301771', 'cui_str': 'Relieved'}, {'cui': 'C0011432', 'cui_str': 'Tooth Sensitivity'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.188804,"No complications and adverse effects were observed.
","[{'ForeName': 'Alexia da Mata', 'Initials': 'ADM', 'LastName': 'Galvão', 'Affiliation': 'Department of Operative Dentistry and Dental Materials, School of Dentistry, Federal University of Uberlândia, Uberlândia, Minas Gerais, 38400-902, Brazil. Electronic address: alexiamgalvao@gmail.com.'}, {'ForeName': 'Livia Fávaro', 'Initials': 'LF', 'LastName': 'Zeola', 'Affiliation': 'Department of Operative Dentistry and Dental Materials, School of Dentistry, Federal University of Uberlândia, Uberlândia, Minas Gerais, 38400-902, Brazil. Electronic address: liviazeola@gmail.com.'}, {'ForeName': 'Guilherme Faria', 'Initials': 'GF', 'LastName': 'Moura', 'Affiliation': 'Department of Operative Dentistry and Dental Materials, School of Dentistry, Federal University of Uberlândia, Uberlândia, Minas Gerais, 38400-902, Brazil. Electronic address: guifamo@gmail.com.'}, {'ForeName': 'Daniela Navarro Ribeiro', 'Initials': 'DNR', 'LastName': 'Teixeira', 'Affiliation': 'Department of Operative Dentistry and Dental Materials, School of Dentistry, Federal University of Uberlândia, Uberlândia, Minas Gerais, 38400-902, Brazil. Electronic address: dnrteixeira@gmail.com.'}, {'ForeName': 'Ramon Corrêa de Queiroz', 'Initials': 'RCQ', 'LastName': 'Gonzaga', 'Affiliation': 'Department of Operative Dentistry and Dental Materials, School of Dentistry, Federal University of Uberlândia, Uberlândia, Minas Gerais, 38400-902, Brazil. Electronic address: ramonfoufu@gmail.com.'}, {'ForeName': 'Gisele Rodrigues', 'Initials': 'GR', 'LastName': 'da Silva', 'Affiliation': 'Department of Operative Dentistry and Dental Materials, School of Dentistry, Federal University of Uberlândia, Uberlândia, Minas Gerais, 38400-902, Brazil. Electronic address: giselerosilva@yahoo.com.br.'}, {'ForeName': 'Paulo Vinícius', 'Initials': 'PV', 'LastName': 'Soares', 'Affiliation': 'Department of Operative Dentistry and Dental Materials, School of Dentistry, Federal University of Uberlândia, Uberlândia, Minas Gerais, 38400-902, Brazil. Electronic address: paulovsoares@yahoo.com.br.'}]",Journal of dentistry,['10.1016/j.jdent.2019.103180']
1834,30686609,A Triple-Blind Randomized Trial of Preemptive Use of Gabapentin Before Laparoscopic Hysterectomy for Benign Gynaecologic Conditions.,"OBJECTIVE


This study sought to examine the efficacy of preemptive use of gabapentin in laparoscopic hysterectomy for benign gynaecologic conditions.
METHODS


In a triple-blind trial, the study investigators randomly assigned women undergoing laparoscopic hysterectomy to receive 600 mg gabapentin (n = 43) or placebo (n = 45) orally 1 hour before the procedure. Patient-controlled opioid analgesia was provided postoperatively. The primary outcome of the trial was cumulative opioid consumption in the first postoperative 24 hours. The study also assessed pain at rest and on movement, the presence of side effects, and patient satisfaction at 2, 8, and 24 hours after surgery.
RESULTS


Between March 10, 2016 and May 1, 2018, 215 women were assessed for eligibility, 110 were randomized, and 88 completed the study. Enrolment was started after trial registration. The investigators found no difference in 24-hour cumulative morphine equivalent opioid consumption between the gabapentin group (26.9 ± 14.7 mg) and the placebo group (27.1 ± 15.1 mg). This provided a mean difference of 0.2 mg (95% CI -6.1 to 6.5, P = 0.943). Pain scores at 2, 8, and 24 hours were also not found to differ between groups. Gabapentin was associated with increased dizziness, but it significantly reduced the use of antiemetic at any time in the first 24 postoperative hours. Patient satisfaction in the two groups was good and not found to differ.
CONCLUSION


Preemptive administration of gabapentin before laparoscopic hysterectomy does not decrease postoperative pain scores and narcotic consumption.",2019,"Patient satisfaction in the two groups was good and not found to differ.
","['Between March 10, 2016 and May 1, 2018, 215 women were assessed for eligibility, 110 were randomized, and 88 completed the study', 'Benign Gynaecologic Conditions']","['placebo', 'Gabapentin', 'Laparoscopic Hysterectomy', 'gabapentin', 'laparoscopic hysterectomy', 'laparoscopic hysterectomy to receive 600 mg gabapentin']","['postoperative pain scores and narcotic consumption', 'Patient satisfaction', '24-hour cumulative morphine equivalent opioid consumption', 'Pain scores', 'cumulative opioid consumption', 'dizziness']","[{'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy (procedure)'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",215.0,0.511221,"Patient satisfaction in the two groups was good and not found to differ.
","[{'ForeName': 'Togas', 'Initials': 'T', 'LastName': 'Tulandi', 'Affiliation': 'Department of Obstetrics and Gynecology, McGill University, Montréal QC. Electronic address: togas.tulandi@mcgill.ca.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Krishnamurthy', 'Affiliation': 'Department of Obstetrics and Gynecology, McGill University, Montréal QC.'}, {'ForeName': 'Fady', 'Initials': 'F', 'LastName': 'Mansour', 'Affiliation': 'Department of Obstetrics and Gynecology, McGill University, Montréal QC.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Suarthana', 'Affiliation': 'Department of Obstetrics and Gynecology, McGill University, Montréal QC.'}, {'ForeName': 'Ghada', 'Initials': 'G', 'LastName': 'Al-Malki', 'Affiliation': 'Department of Obstetrics and Gynecology, McGill University, Montréal QC.'}, {'ForeName': 'Luz Esther Ramos', 'Initials': 'LER', 'LastName': 'Ballesteros', 'Affiliation': 'Department of Obstetrics and Gynecology, McGill University, Montréal QC.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Moore', 'Affiliation': 'Department of Anesthesia, McGill University, Montréal QC.'}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2018.11.019']
1835,31377265,"Effectiveness and safety of the tri-iodothyronine analogue Triac in children and adults with MCT8 deficiency: an international, single-arm, open-label, phase 2 trial.","BACKGROUND


Deficiency of the thyroid hormone transporter monocarboxylate transporter 8 (MCT8) causes severe intellectual and motor disability and high serum tri-iodothyronine (T 3 ) concentrations (Allan-Herndon-Dudley syndrome). This chronic thyrotoxicosis leads to progressive deterioration in bodyweight, tachycardia, and muscle wasting, predisposing affected individuals to substantial morbidity and mortality. Treatment that safely alleviates peripheral thyrotoxicosis and reverses cerebral hypothyroidism is not yet available. We aimed to investigate the effects of treatment with the T 3  analogue Triac (3,3',5-tri-iodothyroacetic acid, or tiratricol), in patients with MCT8 deficiency.
METHODS


In this investigator-initiated, multicentre, open-label, single-arm, phase 2, pragmatic trial, we investigated the effectiveness and safety of oral Triac in male paediatric and adult patients with MCT8 deficiency in eight countries in Europe and one site in South Africa. Triac was administered in a predefined escalating dose schedule-after the initial dose of once-daily 350 μg Triac, the daily dose was increased progressively in 350 μg increments, with the goal of attaining serum total T 3  concentrations within the target range of 1·4-2·5 nmol/L. We assessed changes in several clinical and biochemical signs of hyperthyroidism between baseline and 12 months of treatment. The prespecified primary endpoint was the change in serum T 3  concentrations from baseline to month 12. The co-primary endpoints were changes in concentrations of serum thyroid-stimulating hormone (TSH), free and total thyroxine (T 4 ), and total reverse T 3  from baseline to month 12. These analyses were done in patients who received at least one dose of Triac and had at least one post-baseline evaluation of serum throid function. This trial is registered with ClinicalTrials.gov, number NCT02060474.
FINDINGS


Between Oct 15, 2014, and June 1, 2017, we screened 50 patients, all of whom were eligible. Of these patients, four (8%) patients decided not to participate because of travel commitments. 46 (92%) patients were therefore enrolled in the trial to receive Triac (median age 7·1 years [range 0·8-66·8]). 45 (98%) participants received Triac and had at least one follow-up measurement of thyroid function and thus were included in the analyses of the primary endpoints. Of these 45 patients, five did not complete the trial (two patients withdrew [travel burden, severe pre-existing comorbidity], one was lost to follow-up, one developed of Graves disease, and one died of sepsis). Patients required a mean dose of 38.3 μg/kg of bodyweight (range 6·4-84·3) to attain T 3  concentrations within the target range. Serum T 3  concentration decreased from 4·97 nmol/L (SD 1·55) at baseline to 1·82 nmol/L (0·69) at month 12 (mean decrease 3·15 nmol/L, 95% CI 2·68-3·62; p<0·0001), while serum TSH concentrations decreased from 2·91 mU/L (SD 1·68) to 1·02 mU/L (1·14; mean decrease 1·89 mU/L, 1·39-2·39; p<0·0001) and serum free T 4  concentrations decreased from 9·5 pmol/L (SD 2·5) to 3·4 (1·6; mean decrease 6·1 pmol/L (5·4-6·8; p<0·0001). Additionally, serum total T 4  concentrations decreased by 31·6 nmol/L (28·0-35·2; p<0·0001) and reverse T 3  by 0·08 nmol/L (0·05-0·10; p<0·0001). Seven treatment-related adverse events (transiently increased perspiration or irritability) occurred in six (13%) patients. 26 serious adverse events that were considered unrelated to treatment occurred in 18 (39%) patients (mostly hospital admissions because of infections). One patient died from pulmonary sepsis leading to multi-organ failure, which was unrelated to Triac treatment.
INTERPRETATION


Key features of peripheral thyrotoxicosis were alleviated in paediatric and adult patients with MCT8 deficiency who were treated with Triac. Triac seems a reasonable treatment strategy to ameliorate the consequences of untreated peripheral thyrotoxicosis in patients with MCT8 deficiency.
FUNDING


Dutch Scientific Organization, Sherman Foundation, NeMO Foundation, Wellcome Trust, UK National Institute for Health Research Cambridge Biomedical Centre, Toulouse University Hospital, and Una Vita Rara ONLUS.",2019,"Triac seems a reasonable treatment strategy to ameliorate the consequences of untreated peripheral thyrotoxicosis in patients with MCT8 deficiency.
","['patients with MCT8 deficiency', '50 patients, all of whom were eligible', 'children and adults with MCT8 deficiency', 'Between Oct 15, 2014, and June 1, 2017', 'male paediatric and adult patients with MCT8 deficiency in eight countries in Europe and one site in South Africa', 'paediatric and adult patients with MCT8 deficiency who were treated with Triac', '46 (92%) patients were therefore enrolled in the trial to receive Triac (median age 7·1 years [range 0·8-66·8']","['tri-iodothyronine analogue Triac', ""T 3  analogue Triac (3,3',5-tri-iodothyroacetic acid, or tiratricol""]","['Serum T 3  concentration', 'serum total T 4  concentrations', 'adverse events', 'change in serum T 3  concentrations', 'serum free T 4  concentrations', 'serum TSH concentrations', 'several clinical and biochemical signs of hyperthyroidism', 'concentrations of serum thyroid-stimulating hormone (TSH), free and total thyroxine (T 4 ), and total reverse T 3', 'Effectiveness and safety', '26 serious adverse events', 'perspiration or irritability', 'cerebral hypothyroidism']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0046882', 'cui_str': 'tiratricol'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0202237', 'cui_str': 'Tri-iodothyronine measurement, total (procedure)'}, {'cui': 'C0046882', 'cui_str': 'tiratricol'}, {'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0001128', 'cui_str': 'Acids'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C2609423', 'cui_str': 'Hyperthyroidism (SMQ)'}, {'cui': 'C0857986', 'cui_str': 'Serum thyroid stimulating hormone'}, {'cui': 'C0202231', 'cui_str': 'Thyroxine measurement (procedure)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038990', 'cui_str': 'Sweating'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C2609422', 'cui_str': 'Hypothyroidism (SMQ)'}]",,0.248869,"Triac seems a reasonable treatment strategy to ameliorate the consequences of untreated peripheral thyrotoxicosis in patients with MCT8 deficiency.
","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Groeneweg', 'Affiliation': 'Academic Center for Thyroid Diseases, Erasmus Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'Robin P', 'Initials': 'RP', 'LastName': 'Peeters', 'Affiliation': 'Academic Center for Thyroid Diseases, Erasmus Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Moran', 'Affiliation': 'Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Athanasia', 'Initials': 'A', 'LastName': 'Stoupa', 'Affiliation': ""Paediatric Endocrinology, Diabetology and Gynaecology Department, Necker Children's University Hospital, Imagine Institute, Paris, France.""}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Auriol', 'Affiliation': ""Department of Paediatric Endocrinology and Genetics, Children's Hospital, Toulouse University Hospital, Toulouse, France.""}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Tonduti', 'Affiliation': 'Child Neurology Unit, Fondazione IRCCS, Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Dica', 'Affiliation': 'Paediatric Neurology Clinic, Alexandru Obregia Hospital, Bucharest, Romania.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Paone', 'Affiliation': ""Division of Endocrinology, Bambino Gesu' Children's Research Hospital IRCCS, Rome, Italy.""}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Rozenkova', 'Affiliation': 'Department of Paediatrics, Second Faculty of Medicine, Charles University, University Hospital Motol, Prague, Czech Republic.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Malikova', 'Affiliation': 'Department of Paediatrics, Second Faculty of Medicine, Charles University, University Hospital Motol, Prague, Czech Republic.'}, {'ForeName': 'Adri', 'Initials': 'A', 'LastName': 'van der Walt', 'Affiliation': 'Panorama Medical Centre, Cape Town, South Africa.'}, {'ForeName': 'Irenaeus F M', 'Initials': 'IFM', 'LastName': 'de Coo', 'Affiliation': ""Sophia Children's Hospital, Department of Paediatric Neurology, Erasmus Medical Centre, Rotterdam, Netherlands.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'McGowan', 'Affiliation': 'Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Lyons', 'Affiliation': 'Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Femke K', 'Initials': 'FK', 'LastName': 'Aarsen', 'Affiliation': ""Sophia Children's Hospital, Department of Paediatric Neurology, Erasmus Medical Centre, Rotterdam, Netherlands.""}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Barca', 'Affiliation': 'Paediatric Neurology Clinic, Alexandru Obregia Hospital, Bucharest, Romania; Department of Neurosciences, Paediatric Neurology Discipline II, Carol Davila University of Medicine, Bucharest, Romania.'}, {'ForeName': 'Ingrid M', 'Initials': 'IM', 'LastName': 'van Beynum', 'Affiliation': ""Sophia Children's Hospital, Division of Paediatric Cardiology, Erasmus Medical Centre, Rotterdam, Netherlands.""}, {'ForeName': 'Marieke M', 'Initials': 'MM', 'LastName': 'van der Knoop', 'Affiliation': ""Sophia Children's Hospital, Department of Paediatric Neurology, Erasmus Medical Centre, Rotterdam, Netherlands.""}, {'ForeName': 'Jurgen', 'Initials': 'J', 'LastName': 'Jansen', 'Affiliation': 'Department of Paediatrics, Meander Medical Center, Amersfoort, Netherlands.'}, {'ForeName': 'Martien', 'Initials': 'M', 'LastName': 'Manshande', 'Affiliation': ""'s Heeren Loo, Julianadorp, Netherlands.""}, {'ForeName': 'Roelineke J', 'Initials': 'RJ', 'LastName': 'Lunsing', 'Affiliation': 'Department of Child Neurology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Stan', 'Initials': 'S', 'LastName': 'Nowak', 'Affiliation': 'Department of Paediatrics, Refaja Hospital, Stadskanaal, Netherlands.'}, {'ForeName': 'Corstiaan A', 'Initials': 'CA', 'LastName': 'den Uil', 'Affiliation': 'Department of Cardiology and Intensive Care Medicine, Erasmus Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'M Carola', 'Initials': 'MC', 'LastName': 'Zillikens', 'Affiliation': 'Department of Internal Medicine, Erasmus Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Visser', 'Affiliation': ""'s Heeren Loo, Ermelo, Netherlands.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Vrijmoeth', 'Affiliation': 'Baalderborg, Hardenberg, Netherlands.'}, {'ForeName': 'Marie Claire Y', 'Initials': 'MCY', 'LastName': 'de Wit', 'Affiliation': ""Sophia Children's Hospital, Department of Paediatric Neurology, Erasmus Medical Centre, Rotterdam, Netherlands.""}, {'ForeName': 'Nicole I', 'Initials': 'NI', 'LastName': 'Wolf', 'Affiliation': ""Department of Child Neurology, Emma Children's Hospital, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Amsterdam Neuroscience, Amsterdam, Netherlands.""}, {'ForeName': 'Angelique', 'Initials': 'A', 'LastName': 'Zandstra', 'Affiliation': 'Latyrus, Dedemsvaart, Netherlands.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Ambegaonkar', 'Affiliation': ""Department of Paediatric Neurology, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.""}, {'ForeName': 'Yogen', 'Initials': 'Y', 'LastName': 'Singh', 'Affiliation': ""Department of Paediatric Cardiology, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.""}, {'ForeName': 'Yolanda B', 'Initials': 'YB', 'LastName': 'de Rijke', 'Affiliation': 'Department of Clinical Chemistry, Erasmus Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Medici', 'Affiliation': 'Academic Center for Thyroid Diseases, Erasmus Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'Enrico S', 'Initials': 'ES', 'LastName': 'Bertini', 'Affiliation': ""Unit of Neuromuscular and Neurodegenerative Disorders, Bambino Gesu' Children's Research Hospital IRCCS, Rome, Italy.""}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Depoorter', 'Affiliation': 'Department of Paediatrics, Algemeen Ziekenhuis Sint-Jan, Bruges, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Lebl', 'Affiliation': 'Department of Paediatrics, Second Faculty of Medicine, Charles University, University Hospital Motol, Prague, Czech Republic.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Cappa', 'Affiliation': ""Division of Endocrinology, Bambino Gesu' Children's Research Hospital IRCCS, Rome, Italy.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'De Meirleir', 'Affiliation': 'Paediatric Neurology Unit, Department of Paediatrics, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Krude', 'Affiliation': 'Department of Paediatric Endocrinology and Diabetology, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Craiu', 'Affiliation': 'Paediatric Neurology Clinic, Alexandru Obregia Hospital, Bucharest, Romania; Department of Neurosciences, Paediatric Neurology Discipline II, Carol Davila University of Medicine, Bucharest, Romania.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Zibordi', 'Affiliation': 'Child Neurology Unit, Fondazione IRCCS, Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Oliver Petit', 'Affiliation': ""Department of Paediatric Endocrinology and Genetics, Children's Hospital, Toulouse University Hospital, Toulouse, France.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Polak', 'Affiliation': ""Paediatric Endocrinology, Diabetology and Gynaecology Department, Necker Children's University Hospital, Imagine Institute, Paris, France.""}, {'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Chatterjee', 'Affiliation': 'Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Theo J', 'Initials': 'TJ', 'LastName': 'Visser', 'Affiliation': 'Academic Center for Thyroid Diseases, Erasmus Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'W Edward', 'Initials': 'WE', 'LastName': 'Visser', 'Affiliation': 'Academic Center for Thyroid Diseases, Erasmus Medical Centre, Rotterdam, Netherlands. Electronic address: w.e.visser@erasmusmc.nl.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30155-X']
1836,29706169,A pilot trial of text-delivered peer network counseling to treat young adults with cannabis use disorder.,"Approximately 1.8 million young adults aged 18 to 25 had a Cannabis Use Disorder (CUD) in the past year. Unfortunately, engaging young adults in treatment is very challenging. Creative approaches to treat cannabis disorders such as integrating mobile technology with evidence-based treatments are warranted. In light of these challenges, we developed a text message-delivered version of Peer Network Counseling (PNC-txt), which is a substance use intervention that focuses on peer relations. PNC-txt engages participants in 16 automated, personalized text interactions over 4weeks. We conducted a randomized controlled trial to test the efficacy of PNC-txt against a waitlist control group with 30 treatment seeking young adults (ages 18-25) who met DSM-5 criteria for CUD. Self-report and urine analyses were used to test outcomes at the three-month follow-up. The PNC-txt group significantly reduced their cannabis use related problems as well as cannabis cravings, compared to the control group. PNC-txt participants also had a significantly greater percentage with urines negative for cannabis metabolites compared to controls. Moderation analysis showed that CUD severity level moderated treatment, suggesting that PNC-txt is more effective for participants with medium and high levels of CUD severity. All effect sizes ranged from medium to large. Results from this pilot trial are promising and warrant further research on PNC-txt for addressing cannabis use disorder.",2018,"The PNC-txt group significantly reduced their cannabis use related problems as well as cannabis cravings, compared to the control group.","['group with 30 treatment seeking young adults (ages 18-25) who met DSM-5 criteria for CUD', 'young adults with cannabis use disorder', 'Approximately 1.8 million young adults aged 18 to 25 had a Cannabis Use Disorder (CUD) in the past year']","['PNC-txt against a waitlist control', 'text-delivered peer network counseling']","['cannabis cravings', 'cannabis metabolites']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",0.0,0.0640252,"The PNC-txt group significantly reduced their cannabis use related problems as well as cannabis cravings, compared to the control group.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mason', 'Affiliation': 'Center for Behavioral Health Research, University of Tennessee, Knoxville, TN, United States. Electronic address: mmason29@utk.edu.'}, {'ForeName': 'Nikola M', 'Initials': 'NM', 'LastName': 'Zaharakis', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Russell', 'Affiliation': 'Department of Biobehavioral Health, Pennsylvania State University, United States.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Childress', 'Affiliation': 'Massey Cancer Center, Virginia Commonwealth University, Richmond, VA, United States.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2018.03.002']
1837,9355712,Evaluation of efficacy of standard haemodialysis and verapamil added peritoneal dialysis.,"The study was carried out on 30 adult subjects of acute renal failure who were randomly divided into two groups of 15 patients each. Group A patients were subjected to standard haemodialysis (HD) for 4 hours using holofibre dialyser and group B patients received 36 hours of peritoneal dialysis (PD) where Verapamil was added intraperitonealy in the dose of 10 mg/ L/cycle in the clearance periods III, V, VII, IX and XI (Total dose 150 mg). The 36 hours of PD consisted of 36 cycles of one hour duration each and these were divided into 12 clearance periods (CP) of 3 cycles each. Following both the forms of dialytic treatments, there was significant improvement in the signs of uraemia with fall in the blood urea and serum creatinine levels. The peritoneal clearances, percentage fall of urea and creatinine, and protein loss were similar in the two groups (p > 0.5). However, ultrafiltration was significantly higher in the group B. No untoward effects were noticed in group B however group A patients had episodes of hypotension (5)] disequilibrium (6) and cardiac arrhythmias (1). It can be concluded that both clinically and biochemically, 36 hours of Verapamil added PD and 4 hours of hemodialysis are comparable and therefore, peritoneal dialysis may be used more frequently in acute renal failure specially in situations where trained dialysis staff is not available and patients are not haemodynamically stable.",1997,"However, ultrafiltration was significantly higher in the group B. No untoward effects were noticed in group B however group","['A patients had episodes of hypotension (5)] disequilibrium (6) and cardiac arrhythmias (1', '30 adult subjects of acute renal failure who were randomly divided into two groups of 15 patients each']","['Verapamil', 'standard haemodialysis (HD) for 4 hours using holofibre dialyser and group B patients received 36 hours of peritoneal dialysis (PD) where Verapamil', 'standard haemodialysis and verapamil added peritoneal dialysis']","['clearance periods III, V, VII, IX and XI', 'untoward effects', 'peritoneal clearances, percentage fall of urea and creatinine, and protein loss', 'signs of uraemia with fall in the blood urea and serum creatinine levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0394006', 'cui_str': 'Dysequilibrium syndrome (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3854173', 'cui_str': 'Pre-renal acute kidney injury'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C1292426', 'cui_str': '4 hours (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal Dialysis'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}]","[{'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0445385', 'cui_str': 'VII'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0041948', 'cui_str': 'Uremia'}, {'cui': 'C0005845', 'cui_str': 'BUN'}, {'cui': 'C0600061', 'cui_str': 'Serum creatinine level - finding'}]",30.0,0.0202398,"However, ultrafiltration was significantly higher in the group B. No untoward effects were noticed in group B however group","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Nand', 'Affiliation': 'Deptt. of Medicine (Division of Nephrology) and Biochemistry, Post Graduate Institute of Medical Sciences, Rohtak.'}, {'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Agarwal', 'Affiliation': ''}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Mahajan', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Thukral', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1838,31435653,The Efficacy of Ultrasonic Bone Scalpel for Unilateral Cervical Open-Door Laminoplasty: A Randomized Controlled Trial.,"BACKGROUND


In cervical open-door laminoplasty for cervical myelopathy, a high-speed rotatory drill and rongeurs are used to make unicortical troughs and bicortical openings in the laminae. The lamina is reflected at the trough to enlarge the spinal canal, followed by bone healing on the hinge side to stabilize laminoplasty. The ultrasonic bone scalpel (UBS) has been used due to theoretical advantages including a better hinge union rate, less soft tissue trauma, less neurological injury, and shorter operative time.
OBJECTIVE


To assess the superiority of UBS for hinge union compared to the drill through randomized controlled trial.
METHODS


In 190 randomly allocated cervical myelopathy patients, the trough and opening at the lamina were made using either the drill (n = 95) or UBS (n = 95) during 2015 to 2018. The primary outcome was the hinge union rate on 6-mo postoperative computed tomography. Secondary outcomes included the hinge union rate at 12 mo, the operative time, intraoperative/postoperative bleeding, neurological injury, complications, and clinical outcomes over a 24-mo follow-up.
RESULTS


Hinge union in all laminae was achieved in 60.0% (drill) and 43.9% (UBS) of patients at 6 mo (intention-to-treat analysis; P = .02; odds ratio, 2.1) and in 91.9% (drill) and 86.5% (UBS) at 12 mo. Dural injury only occurred in the drill group (2.1%), and the UBS group showed significantly less intraoperative bleeding (P < .01). The other secondary outcomes did not differ between groups.
CONCLUSION


The hinge union rate was inferior in the UBS group at 6 mo postoperatively, but UBS was efficacious in reducing dural injuries and bleeding.",2020,"The hinge union rate was inferior in the UBS group at 6 mo postoperatively, but UBS was efficacious in reducing dural injuries and bleeding.",['Unilateral Cervical Open-Door Laminoplasty'],"['Ultrasonic Bone Scalpel', 'UBS', 'ultrasonic bone scalpel (UBS']","['intraoperative bleeding', 'hinge union rate', 'hinge union rate on 6-mo postoperative computed tomography', 'dural injuries and bleeding', 'hinge union rate at 12 mo, the operative time, intraoperative/postoperative bleeding, neurological injury, complications, and clinical outcomes over a 24-mo follow-up', 'Dural injury']","[{'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0557698', 'cui_str': 'Door (physical object)'}, {'cui': 'C1535956', 'cui_str': 'Laminoplasty'}]","[{'cui': 'C1456803', 'cui_str': 'Ultrasonics'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0392220', 'cui_str': 'Surgical knife, device (physical object)'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0457406', 'cui_str': 'Hinge (physical object)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0751792', 'cui_str': 'Injuries, Nervous System'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]",190.0,0.0860595,"The hinge union rate was inferior in the UBS group at 6 mo postoperatively, but UBS was efficacious in reducing dural injuries and bleeding.","[{'ForeName': 'Chi Heon', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Chun Kee', 'Initials': 'CK', 'LastName': 'Chung', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Yunhee', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Division of Medical Statistics, Medical Research Collaborating Center, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Calvin C', 'Initials': 'CC', 'LastName': 'Kuo', 'Affiliation': 'Regional Spine Surgery Department, Kaiser Permanente, Oakland, California.'}, {'ForeName': 'Urim', 'Initials': 'U', 'LastName': 'Lee', 'Affiliation': 'Human Brain Function Laboratory, Department of Neurosurgery, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Seung Heon', 'Initials': 'SH', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Chang-Hyun', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Jong-Myung', 'Initials': 'JM', 'LastName': 'Jung', 'Affiliation': 'Department of Neurosurgery, Seoul National University Bundang Hospital, Kyung-gi, South Korea.'}, {'ForeName': 'Sung Hwan', 'Initials': 'SH', 'LastName': 'Hwang', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Dong Hwan', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Joon Ho', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Seoi', 'Initials': 'S', 'LastName': 'Paik', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Hwa Jin', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Sunhyang', 'Initials': 'S', 'LastName': 'Jung', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Sung Bae', 'Initials': 'SB', 'LastName': 'Park', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Kyoung-Tae', 'Initials': 'KT', 'LastName': 'Kim', 'Affiliation': 'Department of Neurosurgery, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Hee-Pyoung', 'Initials': 'HP', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, South Korea.'}]",Neurosurgery,['10.1093/neuros/nyz301']
1839,8906937,Topical flurbiprofen therapy in vernal keratoconjunctivitis.,"A clinical study of 90 cases of vernal keratoconjunctivitis was conducted to ascertain the efficacy of the local use of flurbiprofen and compare its effect with that of betamethasone. According to this study flurbiprofen was found to be effective in vernal keratoconjunctivitis, but less so than betamethasone. Because of the side effects due to prolonged use of steroids, it is recommended that topical flurbiprofen be tried first and in case it is ineffective, it should be replaced by betamethasone.",1995,"According to this study flurbiprofen was found to be effective in vernal keratoconjunctivitis, but less so than betamethasone.","['90 cases of vernal keratoconjunctivitis', 'vernal keratoconjunctivitis']","['flurbiprofen', 'betamethasone', 'Topical flurbiprofen therapy']",[],"[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0022577', 'cui_str': 'Keratoconjunctivitis, Vernal'}]","[{'cui': 'C0016377', 'cui_str': 'Flurbiprofen'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],90.0,0.0132848,"According to this study flurbiprofen was found to be effective in vernal keratoconjunctivitis, but less so than betamethasone.","[{'ForeName': 'R N', 'Initials': 'RN', 'LastName': 'Sud', 'Affiliation': 'Dayanand Medical College & Hospital, Ludhiana.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Greval', 'Affiliation': ''}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Bajwa', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1840,8979541,Bioequivalence studies of celiprolol in healthy human volunteers.,"Thus bioequivalence between the two products was established by undertaking this study. From table 1 it can be seen that the standard deviation at the various sampling points is high indicating varying absorption rates in individual volunteers, but this was observed in case of both the products. Also, since the study design was complete crossover, this high standard deviation was not due to any study design variable. As celiprolol shows non-linear1 dose related absorption kinetics this high value of standard deviation may be due to the intersubject variation during the absorption process. However all the pharmacokinetic parameters showed a comparable profile when statistically evaluated for any significant difference between the two products.",1996,However all the pharmacokinetic parameters showed a comparable profile when statistically evaluated for any significant difference between the two products.,['healthy human volunteers'],['celiprolol'],[],"[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}]","[{'cui': 'C0055021', 'cui_str': 'Celiprolol'}]",[],,0.0163683,However all the pharmacokinetic parameters showed a comparable profile when statistically evaluated for any significant difference between the two products.,"[{'ForeName': 'E K', 'Initials': 'EK', 'LastName': 'Iyer', 'Affiliation': 'Bombay College of Pharmacy, Kalina, Santacruz E.'}, {'ForeName': 'H P', 'Initials': 'HP', 'LastName': 'Tipnis', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1841,31402008,Antibiotic prophylaxis in the surgical management of miscarriage in low-income countries: a cost-effectiveness analysis of the AIMS trial.,"BACKGROUND


There is ongoing debate on the clinical benefits of antibiotic prophylaxis for reducing pelvic infection after miscarriage surgery. We aimed to study the cost-effectiveness of antibiotic prophylaxis in the surgical management of miscarriage in low-income countries.
METHODS


We did an incremental cost-effectiveness analysis using data from 3412 women recruited to the AIMS trial, a randomised, double-blind, placebo-controlled trial designed to evaluate the effectiveness of antibiotic prophylaxis in the surgical management of miscarriage in Malawi, Pakistan, Tanzania, and Uganda. Economic evaluation was done from a health-care-provider perspective on the basis of the outcome of cost per pelvic infection avoided within 2 weeks of surgery. Pelvic infection was broadly defined by the presence of clinical features or the clinically identified need to administer antibiotics. We used non-parametric bootstrapping and multilevel random effects models to estimate incremental mean costs and outcomes. Decision uncertainty was shown via cost-effectiveness acceptability frontiers. The AIMS trial is registered with the ISRCTN registry, number ISRCTN97143849.
FINDINGS


Between June 2, 2014, and April 26, 2017, 3412 women were assigned to receive either antibiotic prophylaxis (1705 [50%] of 3412) or placebo (1707 [50%] of 3412) in the AIMS trial. 158 (5%) of 3412 women developed pelvic infection within 2 weeks of surgery, of whom 68 (43%) were in the antibiotic prophylaxis group and 90 (57%) in the placebo group. There is 97-98% probability that antibiotic prophylaxis is a cost-effective intervention at expected thresholds of willingness-to-pay per additional pelvic infection avoided. In terms of post-surgery antibiotics, the antibiotic prophylaxis group was US$0·27 (95% CI -0·49 to -0·05) less expensive per woman than the placebo group. A secondary analysis, a sensitivity analysis, and all subgroup analyses supported these findings. Antibiotic prophylaxis, if implemented routinely before miscarriage surgery, could translate to an annual total cost saving of up to $1·4 million across the four participating countries and up to $8·5 million across the two regions of sub-Saharan Africa and south Asia.
INTERPRETATION


Antibiotic prophylaxis is more effective and less expensive than no antibiotic prophylaxis. Policy makers in various settings should be confident that antibiotic prophylaxis in miscarriage surgery is cost-effective.
FUNDING


UK Medical Research Council, Wellcome Trust, and the UK Department for International Development.",2019,There is 97-98% probability that antibiotic prophylaxis is a cost-effective intervention at expected thresholds of willingness-to-pay per additional pelvic infection avoided.,"['pelvic infection after miscarriage surgery', 'miscarriage in Malawi, Pakistan, Tanzania, and Uganda', 'Between June 2, 2014, and April 26, 2017, 3412 women', '3412 women recruited to the AIMS trial', 'miscarriage in low-income countries']","['placebo', 'antibiotic prophylaxis', 'Antibiotic prophylaxis']","['pelvic infection', 'Pelvic infection']","[{'cui': 'C0030790', 'cui_str': 'Pelvic Infection'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0282638', 'cui_str': 'Premedication, Antibiotic'}]","[{'cui': 'C0030790', 'cui_str': 'Pelvic Infection'}]",3412.0,0.42792,There is 97-98% probability that antibiotic prophylaxis is a cost-effective intervention at expected thresholds of willingness-to-pay per additional pelvic infection avoided.,"[{'ForeName': 'Ilias', 'Initials': 'I', 'LastName': 'Goranitis', 'Affiliation': 'Health Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Lissauer', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Arri', 'Initials': 'A', 'LastName': 'Coomarasamy', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Amie', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Daniels', 'Affiliation': 'School of Health Sciences, University of Nottingham, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Middleton', 'Affiliation': 'Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Bishop', 'Affiliation': 'Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Hewitt', 'Affiliation': 'Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Weeks', 'Affiliation': 'Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Chisale', 'Initials': 'C', 'LastName': 'Mhango', 'Affiliation': 'College of Medicine, Department of Obstetrics and Gynaecology, Blantyre, Malawi.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Mataya', 'Affiliation': 'College of Medicine, Department of Obstetrics and Gynaecology, Blantyre, Malawi.'}, {'ForeName': 'Iffat', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': 'The Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan.'}, {'ForeName': 'Olufemi T', 'Initials': 'OT', 'LastName': 'Oladapo', 'Affiliation': 'UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Zamora', 'Affiliation': 'Hospital Universitario Ramón y Cajal, CIBER en Epidemiología y Salud Pública (CIBERESP) and Instituto de Investigación Sanitaria (IRYCIS), Madrid, Spain.'}, {'ForeName': 'Tracy E', 'Initials': 'TE', 'LastName': 'Roberts', 'Affiliation': 'Health Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK. Electronic address: t.e.roberts@bham.ac.uk.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30336-5']
1842,31400634,Adjuvant ipilimumab versus placebo after complete resection of stage III melanoma: long-term follow-up results of the European Organisation for Research and Treatment of Cancer 18071 double-blind phase 3 randomised trial.,"BACKGROUND


Since 2015, adjuvant therapy with ipilimumab is an approved treatment for stage III melanoma based on a significantly prolonged recurrence-free survival (RFS). At a median follow-up of 5.3 years, RFS, distant metastasis-free survival (DMFS) and overall survival (OS) were each significantly prolonged in the ipilimumab group compared with the placebo group, despite a 53.3% (ipilimumab) versus 4.6% (placebo) treatment discontinuation rate due to adverse events. We present now long-term follow-up results of this European Organisation for Research and Treatment of Cancer 18071 trial.
PATIENTS, METHODS AND RESULTS


A total of 99 sites randomised 951 patients with stage III cutaneous melanoma (excluding lymph node metastasis ≤1 mm or in-transit metastasis) with adequate resection of lymph nodes to receive intravenous infusions of ipilimumab 10 mg/kg or placebo, every 3 weeks for 4 doses, then every 3 months for up to 3 years. The RFS, DMFS and OS, as reported by the local investigators, were assessed by the intention-to-treat analysis. Among 431 patients randomised at 63 sites and who were still alive at the analysis reported in 2016, recent follow-up information could be obtained for 264 patients. The median OS follow-up was 6.9 years. The RFS (hazard ratio [HR] 0.75, 95% confidence interval 0.63-0.88; P < 0.001), DMFS (HR 0.76, 0.64-0.90; P = 0.002) and OS (HR 0.73, 0.60-0.89; P = 0.002) benefit observed in the ipilimumab group was durable with an 8.7% absolute difference at 7 years for OS. The benefit was consistent across subgroups.
CONCLUSIONS


Adjuvant therapy with ipilimumab prolongs RFS, DMFS and OS significantly. The benefit is sustained long term and consistent across subgroups.",2019,"At a median follow-up of 5.3 years, RFS, distant metastasis-free survival (DMFS) and overall survival (OS) were each significantly prolonged in the ipilimumab group compared with the placebo group, despite a 53.3% (ipilimumab) versus 4.6% (placebo) treatment discontinuation rate due to adverse events.","['431 patients randomised at 63 sites and who were still alive at the analysis reported in 2016, recent follow-up information could be obtained for 264 patients', 'after complete resection of stage III melanoma', 'A total of 99 sites randomised 951 patients with stage III cutaneous melanoma (excluding lymph node metastasis ≤1\xa0mm or in-transit metastasis) with adequate resection of lymph nodes to receive']","['intravenous infusions of ipilimumab 10\xa0mg/kg or placebo', 'placebo', 'ipilimumab', 'Adjuvant ipilimumab']","['RFS, distant metastasis-free survival (DMFS) and overall survival (OS', 'DMFS ']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}]","[{'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",951.0,0.692446,"At a median follow-up of 5.3 years, RFS, distant metastasis-free survival (DMFS) and overall survival (OS) were each significantly prolonged in the ipilimumab group compared with the placebo group, despite a 53.3% (ipilimumab) versus 4.6% (placebo) treatment discontinuation rate due to adverse events.","[{'ForeName': 'Alexander M M', 'Initials': 'AMM', 'LastName': 'Eggermont', 'Affiliation': 'Gustave Roussy Cancer Insitute and University Paris-Sud, France. Electronic address: alexander.eggermont@gustaveroussy.fr.'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion-Sileni', 'Affiliation': 'Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'AIX-Marseille University, Marseille, France.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'University of Zurich Hospital, Zurich, Switzerland.'}, {'ForeName': 'Jedd D', 'Initials': 'JD', 'LastName': 'Wolchok', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Schmidt', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'The Angeles Clinic and Research Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Melanoma Department, Gustave Roussy Institute and Univerity Paris-Sud, France.'}, {'ForeName': 'Paolo Antonio', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS ""Fondazione G. Pascale"", Naples, Italy.'}, {'ForeName': 'Jon M', 'Initials': 'JM', 'LastName': 'Richards', 'Affiliation': 'Oncology Specialists, SC, Park Ridge, IL, USA.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Lebbe', 'Affiliation': 'Dermatology and CIC Department, AP-HP, Saint-Louis Hospital, Université de Paris, INSERM U976, Paris, France.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Ferraresi', 'Affiliation': 'Regina Elena National Cancer Institute, Rome, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Smylie', 'Affiliation': 'Cross Cancer Institute, Edmonton, AB, Canada.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Weber', 'Affiliation': 'New York University Perlmutter Cancer Center, New York, NY, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Maio', 'Affiliation': 'Center for Immuno-Oncology, University Hospital of Siena, Siena, Italy.'}, {'ForeName': 'Fareeda', 'Initials': 'F', 'LastName': 'Hosein', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, NJ, USA.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'de Pril', 'Affiliation': ""Bristol-Myers Squibb, Braine-L'alleud, Belgium.""}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kicinski', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Testori', 'Affiliation': 'Formerly at European Institute of Oncology, Milan, Italy.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.07.001']
1843,31377534,Randomized controlled trial of the Child Protection Unit: Grade and gender as moderators of CSA prevention concepts in elementary students.,"BACKGROUND


Despite the importance of child sexual abuse (CSA) prevention, there are few recent randomized controlled trials of school-based CSA prevention programs.
OBJECTIVES


(1) To evaluate the effects of the Second Step Child Protection Unit (CPU) on students' CSA prevention concept knowledge, ability to recognize, report, and refuse unsafe touches, and perceptions of teacher-student relations and (2) investigate the moderating role of age and gender on program effectiveness.
PARTICIPANTS AND SETTING


Eight elementary schools in a large suburban school district in the northeast United States were randomly assigned to the intervention or control condition, with analyses conducted on a total of 2172 students.
METHODS


Students in intervention schools received the 6-week CPU and those in the control schools were exposed to business as usual. Students were administered assessments at baseline and then at post-test.
RESULTS


Univariate Analyses of Covariance revealed that students in the intervention schools had significantly higher scores on all outcomes than students in the control schools at post-test, even after controlling for baseline scores. Children in younger grades made greater gains from the program, and girls scored higher than boys in CSA knowledge and ability to recognize, refuse, and report unsafe touches, but both boys and girls made significant gains.
CONCLUSIONS


Results support the importance of beginning early with school-based CSA prevention efforts. Although boys are still at a relative disadvantage in terms of their knowledge and ability in this area, they are able to make gains at the same rate as girls.",2019,"RESULTS


Univariate Analyses of Covariance revealed that students in the intervention schools had significantly higher scores on all outcomes than students in the control schools at post-test, even after controlling for baseline scores.","['Eight elementary schools in a large suburban school district in the northeast United States were randomly assigned to the intervention or control condition, with analyses conducted on a total of 2172 students', 'elementary students', 'Students in intervention schools received the 6-week', 'child sexual abuse (CSA) prevention']","['CPU', 'Second Step Child Protection Unit (CPU']",[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0008062', 'cui_str': 'Molestation, Sexual, Child'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0337542', 'cui_str': 'Stepchild (person)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]",[],,0.0238781,"RESULTS


Univariate Analyses of Covariance revealed that students in the intervention schools had significantly higher scores on all outcomes than students in the control schools at post-test, even after controlling for baseline scores.","[{'ForeName': 'Amanda B', 'Initials': 'AB', 'LastName': 'Nickerson', 'Affiliation': 'University at Buffalo, State University of New York, United States. Electronic address: nickersa@buffalo.edu.'}, {'ForeName': 'Jenine', 'Initials': 'J', 'LastName': 'Tulledge', 'Affiliation': 'University at Buffalo, State University of New York, United States.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Manges', 'Affiliation': 'University at Buffalo, State University of New York, United States.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Kesselring', 'Affiliation': 'University at Buffalo, State University of New York, United States.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Parks', 'Affiliation': 'University at Buffalo, State University of New York, United States.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Livingston', 'Affiliation': 'University at Buffalo, State University of New York, United States.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Dudley', 'Affiliation': 'University at Buffalo, State University of New York, United States.'}]",Child abuse & neglect,['10.1016/j.chiabu.2019.104101']
1844,31432080,Postsurgical Electrical Stimulation Enhances Recovery Following Surgery for Severe Cubital Tunnel Syndrome: A Double-Blind Randomized Controlled Trial.,"BACKGROUND


Patients with severe cubital tunnel syndrome often have poor functional recovery with conventional surgical treatment. Postsurgical electrical stimulation (PES) has been shown to enhance axonal regeneration in animal and human studies.
OBJECTIVE


To determine if PES following surgery for severe cubital tunnel syndrome would result in better outcomes compared to surgery alone.
METHODS


Patients with severe cubital tunnel syndrome in this randomized, double-blind, placebo-controlled trial were randomized in a 1:2 ratio to the control or stimulation groups. Control patients received cubital tunnel surgery and sham stimulation, whereas patients in the stimulation group received 1-h of 20 Hz PES following surgery. Patients were assessed by a blinded evaluator annually for 3 yr. The primary outcome was motor unit number estimation (MUNE) and secondary outcomes were grip and key pinch strength and McGowan grade and compound muscle action potential.
RESULTS


A total of 31 patients were enrolled: 11 received surgery alone and 20 received surgery and PES. Three years following surgery, MUNE was significantly higher in the PES group (176 ± 23, mean + SE) compared to controls (88 ± 11, P < .05). The mean gain in key pinch strength in the PES group was almost 3 times greater than in the controls (P < .05). Similarly, other functional and physiological outcomes showed significantly greater improvements in the PES group.
CONCLUSION


PES enhanced muscle reinnervation and functional recovery following surgery for severe cubital tunnel syndrome. It may be a clinically useful adjunct to surgery for severe ulnar neuropathy, in which functional recovery with conventional treatment is often suboptimal.",2020,The mean gain in key pinch strength in the PES group was almost 3 times greater than in the controls (P < .05).,"['31 patients were enrolled: 11 received', 'Severe Cubital Tunnel Syndrome', 'Patients with severe cubital tunnel syndrome', 'severe cubital tunnel syndrome']","['Postsurgical electrical stimulation (PES', 'surgery alone and 20 received surgery and PES', 'placebo', '20 Hz PES', 'cubital tunnel surgery and sham stimulation', 'Postsurgical Electrical Stimulation Enhances Recovery Following Surgery']","['motor unit number estimation (MUNE) and secondary outcomes were grip and key pinch strength and McGowan grade and compound muscle action potential', 'mean gain in key pinch strength', 'muscle reinnervation and functional recovery']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0206239', 'cui_str': 'Ulnar Nerve Compression, Cubital Tunnel'}]","[{'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0230376', 'cui_str': 'Structure of ulnar tunnel'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0429357', 'cui_str': 'Motor unit number (observable entity)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}, {'cui': 'C0429272', 'cui_str': 'Key pinch (observable entity)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0522028', 'cui_str': 'Muscle action potential, function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0231508', 'cui_str': 'Reinnervation (finding)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.555596,The mean gain in key pinch strength in the PES group was almost 3 times greater than in the controls (P < .05).,"[{'ForeName': 'Hollie A', 'Initials': 'HA', 'LastName': 'Power', 'Affiliation': 'Division of Plastic Surgery, Department of Surgery, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morhart', 'Affiliation': 'Division of Plastic Surgery, Department of Surgery, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Jaret L', 'Initials': 'JL', 'LastName': 'Olson', 'Affiliation': 'Division of Plastic Surgery, Department of Surgery, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'K Ming', 'Initials': 'KM', 'LastName': 'Chan', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Canada.'}]",Neurosurgery,['10.1093/neuros/nyz322']
1845,8045623,The biological factors in the etiopathogenesis and management of cervical spondylosis.,Two hundred cases of cervical spondylosis were studied for 1 to 4 average (2 1/2) years. No co-relation could be established between the clinical features and the radiological findings in these cases. It was found that parasites play an important role in the multifactorial etiology of this condition and their eradication by deworming drugs gives better results than the traditional therapies. Many new hypotheses are proposed to explain the same.,1994,No co-relation could be established between the clinical features and the radiological findings in these cases.,['Two hundred cases of cervical spondylosis were studied for 1 to 4 average (2 1/2) years'],[],[],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1384641', 'cui_str': 'Cervical spondylosis (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],[],,0.0135614,No co-relation could be established between the clinical features and the radiological findings in these cases.,"[{'ForeName': 'G N', 'Initials': 'GN', 'LastName': 'Khare', 'Affiliation': 'Department of Orthopaedics, Banaras Hindu University, Varanasi, India.'}]",Indian journal of medical sciences,[]
1846,31314073,"Urine Tenofovir Concentrations Correlate With Plasma and Relate to Tenofovir Disoproxil Fumarate Adherence: A Randomized, Directly Observed Pharmacokinetic Trial (TARGET Study).","BACKGROUND


Direct measurement of tenofovir (TFV) in urine could be an objective measure to monitor adherence to preexposure prophylaxis (PrEP) or TFV-based antiretroviral therapy (ART).
METHODS


We conducted a 3-arm randomized, pharmacokinetic study of tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg among adults living with human immunodeficiency virus. Participants were randomized to receive controlled TDF/FTC dosing as (1) ""perfect"" adherence (daily); (2) ""moderate"" adherence (4 doses/week); or (3) ""low"" adherence (2 doses/week). We obtained trough spot urine and plasma samples during a 6-week directly observed therapy period and a 4-week washout period. TFV concentrations were compared between adherence arms using 1-way analysis of variance.
RESULTS


Among 28 participants, the median age was 33 years and 16 (57%) were male. Correlation between TFV plasma and urine concentrations was strong (ρ = 0.78; P < .0001). Median (interquartile range) steady-state trough TFV concentrations (ng/mL) for perfect, moderate, and low TDF adherence were 41 (26-52), 16 (14-19), and 4 (3-5) in plasma; and 6480 (3940-14 300), 3405 (2210-5020), and 448 (228-675) in urine. Trough TFV concentrations at steady state were significantly different between the 3 adherence arms for plasma (P < .0001) and urine (P = .0002). Following drug cessation, TFV concentrations persisted longer in urine than plasma samples. Washout urine TFV concentrations and time to undetectable concentrations did not differ between the 3 randomized adherence groups.
CONCLUSIONS


Urine TFV concentrations can inform interpretation of novel point-of-care urine-based TFV assays to assess recent TDF adherence.
CLINICAL TRIALS REGISTRATION


NCT0301260.",2020,Trough TFV concentrations at steady state were significantly different between the three adherence arms for plasma (p<0.0001) and urine (p=0.0002).,"['HIV-uninfected adults', '28 participants, mean age was 33 years and 16 (57%) were male', 'adults with controlled levels of adherence to advance development and enable interpretation of point-of-care urine assays']","['controlled TDF/FTC', 'tenofovir (TFV', 'tenofovir disoproxil fumarate (TDF) 300mg/emtricitabine (FTC']","['Washout urine TFV concentrations and time-to-undetectable concentrations', 'Median [IQR] steady-state trough TFV concentrations (ng/mL) for perfect, moderate, and low TDF adherence in plasma', 'TDF Adherence', 'urine TFV concentrations', 'Trough TFV concentrations', 'TFV plasma and urine concentrations', 'TFV concentrations']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0619283', 'cui_str': 'IS 33'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0459471', 'cui_str': 'Interpretation (attribute)'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0042037'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}]","[{'cui': 'C0042037'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",28.0,0.15944,Trough TFV concentrations at steady state were significantly different between the three adherence arms for plasma (p<0.0001) and urine (p=0.0002).,"[{'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Drain', 'Affiliation': 'Department of Global Health, University of Washington, Seattle.'}, {'ForeName': 'Rachel W', 'Initials': 'RW', 'LastName': 'Kubiak', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle.'}, {'ForeName': 'Oraphan', 'Initials': 'O', 'LastName': 'Siriprakaisil', 'Affiliation': 'Sanpatong Hospital, Chiang Mai, Thailand.'}, {'ForeName': 'Virat', 'Initials': 'V', 'LastName': 'Klinbuayaem', 'Affiliation': 'Sanpatong Hospital, Chiang Mai, Thailand.'}, {'ForeName': 'Justice', 'Initials': 'J', 'LastName': 'Quame-Amaglo', 'Affiliation': 'Department of Global Health, University of Washington, Seattle.'}, {'ForeName': 'Pra-Ornsuda', 'Initials': 'PO', 'LastName': 'Sukrakanchana', 'Affiliation': 'Program for HIV Prevention and Treatment (PHPT) lab at Chiang Mai University/IRD UMI 174, Thailand.'}, {'ForeName': 'Suriyan', 'Initials': 'S', 'LastName': 'Tanasri', 'Affiliation': 'Program for HIV Prevention and Treatment (PHPT) lab at Chiang Mai University/IRD UMI 174, Thailand.'}, {'ForeName': 'Pimpinun', 'Initials': 'P', 'LastName': 'Punyati', 'Affiliation': 'Program for HIV Prevention and Treatment (PHPT) lab at Chiang Mai University/IRD UMI 174, Thailand.'}, {'ForeName': 'Wasna', 'Initials': 'W', 'LastName': 'Sirirungsi', 'Affiliation': 'Department of Medical Technology, Faculty of Associated Medical Sciences, Chiang Mai University, Thailand.'}, {'ForeName': 'Ratchada', 'Initials': 'R', 'LastName': 'Cressey', 'Affiliation': 'Department of Medical Technology, Faculty of Associated Medical Sciences, Chiang Mai University, Thailand.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bacchetti', 'Affiliation': 'University of California, San Francisco, Boston, Massachusetts.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Okochi', 'Affiliation': 'University of California, San Francisco, Boston, Massachusetts.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Global Health, University of Washington, Seattle.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'University of California, San Francisco, Boston, Massachusetts.'}, {'ForeName': 'Tim R', 'Initials': 'TR', 'LastName': 'Cressey', 'Affiliation': 'Program for HIV Prevention and Treatment (PHPT) lab at Chiang Mai University/IRD UMI 174, Thailand.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz645']
1847,31423712,"Safety, Tolerability and efficacy of Rapid Optimization, helped by NT-proBNP and GDF-15, of Heart Failure therapies (STRONG-HF): rationale and design for a multicentre, randomized, parallel-group study.","AIMS


Patients admitted for acute heart failure (HF) are at high risk of readmission and death, especially in the 90 days following discharge. We aimed to assess the safety and efficacy of early optimization of oral HF therapy with beta-blockers (BB), angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB) or angiotensin receptor-neprilysin inhibitors (ARNi), and mineralocorticoid receptor antagonists (MRA) on 90-day clinical outcomes in patients admitted for acute HF.
METHODS


In a multicentre, randomized, open-label, parallel-group study, a total of 900 patients will be randomized in a 1:1 ratio to either 'usual care' or 'high-intensity care'. Patients enrolled in the usual care arm will be discharged and managed according to usual clinical practice at the site. In the high-intensity care arm, doses of oral HF medications - including a BB, ACEi or ARB, and MRA - will be up-titrated to 50% of recommended doses before discharge and to 100% of recommended doses within 2 weeks of discharge. Up-titration will be delayed if the patients develop worsening symptoms and signs of congestion, hyperkalaemia, hypotension, bradycardia, worsening of renal function or significant increase in N-terminal pro-B-type natriuretic peptide between visits. The primary endpoint is 90-day all-cause mortality or HF readmission.
CONCLUSIONS


STRONG-HF is the first study to assess whether rapid up-titration of evidence-based guideline-recommended therapies with close follow-up in a large cohort of patients discharged from an acute HF admission is safe and can affect adverse outcomes during the first 90 days after discharge.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT03412201.",2019,"Up-titration will be delayed if the patients develop worsening symptoms and signs of congestion, hyperkalaemia, hypotension, bradycardia, worsening of renal function or significant increase in N-terminal pro-B-type natriuretic peptide between visits.","[""900 patients will be randomized in a 1:1 ratio to either 'usual care' or 'high-intensity care"", 'patients admitted for acute HF', 'Patients admitted for acute heart failure (HF', 'Patients enrolled in the usual care arm will be discharged and managed according to usual clinical practice at the site']","['oral HF therapy with beta-blockers (BB), angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB) or angiotensin receptor-neprilysin inhibitors (ARNi), and mineralocorticoid receptor antagonists (MRA']","['90-day all-cause mortality or HF readmission', 'Safety, Tolerability and efficacy', 'safety and efficacy']","[{'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor (substance)'}, {'cui': 'C0025250', 'cui_str': 'CALLA Antigen'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",900.0,0.0977579,"Up-titration will be delayed if the patients develop worsening symptoms and signs of congestion, hyperkalaemia, hypotension, bradycardia, worsening of renal function or significant increase in N-terminal pro-B-type natriuretic peptide between visits.","[{'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Kimmoun', 'Affiliation': 'INSERM UMR-S 942, St. Louis and Lariboisère University Hospitals, Paris University, Paris, France.'}, {'ForeName': 'Gad', 'Initials': 'G', 'LastName': 'Cotter', 'Affiliation': 'Momentum Research Inc., Durham, NC, USA.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Davison', 'Affiliation': 'Momentum Research Inc., Durham, NC, USA.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Takagi', 'Affiliation': 'INSERM UMR-S 942, St. Louis and Lariboisère University Hospitals, Paris University, Paris, France.'}, {'ForeName': 'Faouzi', 'Initials': 'F', 'LastName': 'Addad', 'Affiliation': 'Department of Cardiology, Abderrahmen Mami University hospital, Ariana, Tunisia.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Celutkiene', 'Affiliation': 'Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Chioncel', 'Affiliation': ""Emergency Institute for Cardiovascular Diseases 'Prof. C.C. Iliescu', University of Medicine 'Carol Davila', Bucharest, Romania.""}, {'ForeName': 'Alain Cohen', 'Initials': 'AC', 'LastName': 'Solal', 'Affiliation': 'INSERM UMR-S 942, St. Louis and Lariboisère University Hospitals, Paris University, Paris, France.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina.'}, {'ForeName': 'Albertino', 'Initials': 'A', 'LastName': 'Damasceno', 'Affiliation': 'Eduardo Mondlane University Hospital, Maputo, Mozambique.'}, {'ForeName': 'Hans-Dirk', 'Initials': 'HD', 'LastName': 'Duengen', 'Affiliation': 'Department of Internal Medicine - Cardiology, Campus Virchow Klinikum, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'Heart Failure Unit, Attikon University Hospital, National and Kapodistrian University of Athens, Greece; School of Medicine, University of Cyprus, Nicosia, Cyprus.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Goncalvesova', 'Affiliation': 'Department of Heart Failure and Transplantation, National Institute of Cardiovascular Diseases, Bratislava, Slovak Republic.'}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Merai', 'Affiliation': 'Cardiac Care Unit, Moscow City Hospital, Moscow, Russia.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Cardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Department of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Privalov', 'Affiliation': 'Critical Cardiac Unit, City Clinical Hospital, Moscow, Russia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sliwa', 'Affiliation': 'Division of Cardiology, Department of Medicine, Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mahmoud Umar', 'Initials': 'MU', 'LastName': 'Sani', 'Affiliation': 'Department of Medicine, Bayero University Kano, Kano, Nigeria.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'Department of Cardiology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Zaur', 'Initials': 'Z', 'LastName': 'Shogenov', 'Affiliation': 'Moscow SHI, City Clinical Hospital, Moscow, Russia.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mebazaa', 'Affiliation': 'INSERM UMR-S 942, St. Louis and Lariboisère University Hospitals, Paris University, Paris, France.'}]",European journal of heart failure,['10.1002/ejhf.1575']
1848,31108015,"Efficacy and safety of a two-drug direct-acting antiviral agent regimen ruzasvir 180 mg and uprifosbuvir 450 mg for 12 weeks in adults with chronic hepatitis C virus genotype 1, 2, 3, 4, 5 or 6.","Ruzasvir (MK-8408, an NS5A inhibitor) and uprifosbuvir (MK-3682, a nonstructural protein 5B nucleotide inhibitor) are highly potent direct-acting antiviral agents for the treatment of hepatitis C virus (HCV) infection. A phase III clinical trial evaluating the two-drug combination of ruzasvir 60 mg plus  uprifosbuvir 450 mg suggested suboptimal efficacy in certain HCV genotypes (C-BREEZE 1; NCT02759315). The aim of the present study was to evaluate the efficacy and safety of ruzasvir in combination with uprifosbuvir administered at a higher dose than that assessed in the earlier study (C-BREEZE 2: NCT02956629/Merck protocol PN041). Treatment-naïve or interferon (with or without ribavirin)-experienced participants with or without compensated cirrhosis were enrolled. All participants received ruzasvir 180 mg plus uprifosbuvir 450 mg once daily for 12 weeks. The primary objectives were the proportion of participants with HCV RNA <15 lU/mL at 12 weeks after the end of study therapy (SVR12), and safety and tolerability of the study drug. Overall, 282 participants were enrolled. SVR12 (n/N) was 91.3% (42/46) in participants infected with HCV genotype (GT) 1a; GT1b, 96.7% (29/30); GT2, 91.5% (43/47); GT3, 73.8% (45/61); GT4, 98.2% (55/56); GT5, 100.0% (18/18); and GT6, 90.9% (20/22). Adverse events (AEs) were reported by 61.3% of participants; drug-related AEs were reported by 33.3%. The most frequent (≥5% of participants) drug-related AEs in all participants were fatigue (7.8%) and headache (7.4%). In conclusion, the two-drug combination of ruzasvir 180 mg plus uprifosbuvir 450 mg for 12 weeks was highly effective and well tolerated in participants infected with HCV GT1, GT2, GT4, GT5 and GT6, with a lower efficacy in GT3-infected persons.",2019,Adverse events (AEs) were reported by 61.3% of participants; drug-related AEs were reported by 33.3%.,"['participants with or without compensated cirrhosis were enrolled', 'Adults with Chronic Hepatitis C Virus Genotype 1, 2, 3, 4, 5, or 6', '282 participants were enrolled']","['Ruzasvir 180 mg and Uprifosbuvir', 'Two-Drug Direct-Acting Antiviral Agent Regimen', 'ruzasvir 180\u2009mg\u2009plus\u2009uprifosbuvir 450\u2009mg once daily for 12 weeks', 'Ruzasvir (MK-8408, an NS5A inhibitor) and uprifosbuvir (MK-3682', 'Treatment-naive or interferon\u2009(with or without\u2009ribavirin)-experienced', 'ruzasvir']","['safety and tolerability', 'headache', 'effective and well-tolerated', 'Efficacy and Safety', 'Adverse events (AEs', 'efficacy and safety of rusasvir']","[{'cui': 'C0205432', 'cui_str': 'Compensated (qualifier value)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3805156', 'cui_str': 'Chronic hepatitis C virus genotype 1'}, {'cui': 'C4517681', 'cui_str': '282'}]","[{'cui': 'C4508570', 'cui_str': ""Carbamic acid, N,N'-(((6S)-6-(2-cyclopropyl-5-thiazolyl)-1-fluoro-6H-indolo(1,2-c)(1,3)benzoxazine-3,10-diyl)bis(1H-imidazole-5,2-diyl(2S)-2,1-pyrrolidinediyl((1S)-1-(1-methylethyl)-2-oxo-2,1-ethanedi yl)))bis-, dimethyl ester""}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C4706174', 'cui_str': ""Uridine, 2'-chloro-2'-deoxy-2'-methyl-5'-O-((R)-(((1R)-1-methyl-2-(1-methylethoxy)-2-oxoethyl)amino)phenoxyphosphinyl)-""}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0003451', 'cui_str': 'Antiviral Drugs'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4550236', 'cui_str': 'MK-8408'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4706175', 'cui_str': 'MK-3682'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",282.0,0.0403518,Adverse events (AEs) were reported by 61.3% of participants; drug-related AEs were reported by 33.3%.,"[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lawitz', 'Affiliation': 'Texas Liver Institute, University of Texas Health San Antonio, San Antonio, Texas.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Gane', 'Affiliation': 'Auckland Clinical Studies, Auckland, New Zealand.'}, {'ForeName': 'Jordan J', 'Initials': 'JJ', 'LastName': 'Feld', 'Affiliation': 'Toronto Centre for Liver Disease, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Buti', 'Affiliation': ""Liver Unit Hospital Universitari Vall d'Hebron and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd) del Instituto de Salud Carlos III, Barcelona, Spain.""}, {'ForeName': 'Graham R', 'Initials': 'GR', 'LastName': 'Foster', 'Affiliation': 'Queen Mary University, London, UK.'}, {'ForeName': 'Mordechai', 'Initials': 'M', 'LastName': 'Rabinovitz', 'Affiliation': 'University of Pittsburgh Medical Center, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Burnevich', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University, Moscow, Russia.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Katchman', 'Affiliation': 'Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Tomasiewicz', 'Affiliation': 'Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Lahser', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Jackson', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Shaughnessy', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Klopfer', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Wendy W', 'Initials': 'WW', 'LastName': 'Yeh', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Robertson', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Hanna', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Eliav', 'Initials': 'E', 'LastName': 'Barr', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Platt', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of viral hepatitis,['10.1111/jvh.13132']
1849,31046033,"Effects of a standardized extract of Withania somnifera (Ashwagandha) on depression and anxiety symptoms in persons with schizophrenia participating in a randomized, placebo-controlled clinical trial.","BACKGROUND


Extracts of Withania somnifera (WSE), or Ashwagandha, has traditionally been used as an adaptogen in Ayurvedic medicine, and evidence suggests that it may have efficacy in the treatment of psychiatric disorders, including schizophrenia. This secondary analysis reviewed change in depression and anxiety symptoms in a study using WSE as an adjunctive treatment in patients with schizophrenia experiencing an exacerbation of positive symptoms.
METHODS


We enrolled patients with schizophrenia in a 12-week, randomized, placebo-controlled, double-blind study. Active treatment was with 1,000 mg of standardized WSE. This analysis reviewed outcomes for 66 patients with depression and anxiety symptoms by examining the singleitem depression and anxiety-depression cluster subscores extracted from the Positive and Negative Syndrome Scale.
RESULTS


Medium effect sizes of 0.683 (95% confidence interval [CI], 0.16 to 1.21) and 0.686 (95% CI, 0.16 to 1.21) favoring WSE over placebo were observed for depression single-item and anxiety-depression cluster scores, respectively. Adverse events were mild and transient.
CONCLUSIONS


Our findings suggest that WSE may hold promise in the treatment of depression and anxiety symptoms in schizophrenia. While the mechanism of its clinical efficacy requires more exploration, the data suggest.",2019,"RESULTS


Medium effect sizes of 0.683 (95% confidence interval [CI], 0.16 to 1.21) and 0.686 (95% CI, 0.16 to 1.21) favoring WSE over placebo were observed for depression single-item and anxiety-depression cluster scores, respectively.","['enrolled patients with schizophrenia', '66 patients with depression and anxiety symptoms by examining the singleitem depression and anxiety-depression cluster subscores extracted from the Positive and Negative Syndrome Scale', 'persons with schizophrenia participating', 'patients with schizophrenia experiencing an exacerbation of positive symptoms']","['WSE', 'standardized extract of Withania somnifera (Ashwagandha', 'placebo']","['Adverse events', 'depression single-item and anxiety-depression cluster scores', 'depression and anxiety symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder (disorder)'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C1061163', 'cui_str': 'Withania somnifera'}, {'cui': 'C0613707', 'cui_str': 'Ashwagandha'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",,0.500645,"RESULTS


Medium effect sizes of 0.683 (95% confidence interval [CI], 0.16 to 1.21) and 0.686 (95% CI, 0.16 to 1.21) favoring WSE over placebo were observed for depression single-item and anxiety-depression cluster scores, respectively.","[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Gannon', 'Affiliation': 'Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, Pittsburgh, PA 15213 USA. E-MAIL: gannonjm@upmc.edu.'}, {'ForeName': 'Jaspreet', 'Initials': 'J', 'LastName': 'Brar', 'Affiliation': ''}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Rai', 'Affiliation': ''}, {'ForeName': 'K N Roy', 'Initials': 'KNR', 'LastName': 'Chengappa', 'Affiliation': ''}]",Annals of clinical psychiatry : official journal of the American Academy of Clinical Psychiatrists,[]
1850,8002057,Tuberculosis screening: usefulness of new KREATECH IgA ELISA test.,"A total of 71 sera from 15 proved cases of pulmonary tuberculosis, 2 cases with doubtful radiological report and 54 suspected cases, contacts, donors etc. were subjected to Elisa IgG, IgM and IgA tests for tuberculosis, with a view to comparing the merits of IgA test with those of IgG and IgM. Kreatech IgA test which is claimed to indicate presence of active tuberculosis was positive in 13 of the proved cases and negative in both the doubtful cases. These preliminary results indicate that KREATECH IgA is a promising new ELISA test which can be a useful laboratory aid in the diagnosis of active tuberculosis, both pulmonary and extrapulmonary, for screening of suspected cases, and for monitoring cases undergoing therapy.",1994,"These preliminary results indicate that KREATECH IgA is a promising new ELISA test which can be a useful laboratory aid in the diagnosis of active tuberculosis, both pulmonary and extrapulmonary, for screening of suspected cases, and for monitoring cases undergoing therapy.",[],[],[],[],[],[],71.0,0.0174623,"These preliminary results indicate that KREATECH IgA is a promising new ELISA test which can be a useful laboratory aid in the diagnosis of active tuberculosis, both pulmonary and extrapulmonary, for screening of suspected cases, and for monitoring cases undergoing therapy.","[{'ForeName': 'D D', 'Initials': 'DD', 'LastName': 'Banker', 'Affiliation': 'Special Reference Laboratory and Bharat Serums & Vaccines Pvt. Ltd., Bombay.'}, {'ForeName': 'V G', 'Initials': 'VG', 'LastName': 'Daftary', 'Affiliation': ''}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Daftary', 'Affiliation': ''}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Pal', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sandhya', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1851,7875749,Evaluation of diclofenac sodium as a perioperative analgesic.,"1. This study was undertaken to assess whether the analgesia conferred by Diclofenac sodium in the post operative period following general surgery is enhanced by preoperative administration of the drug. 2. Two groups of patients were studied. Group I patients received narcotic premedication and Group II patients received Diclofenac sodium as premedication. Post operatively both groups were administered intramuscular Diclofenac sodium 8 hourly for 48 hours. 3. Pain scoring using visual analogue scale indicated a better pain relief in Group II patients. In Group I, 75% patients had a pain score less than 3 whereas 85% in Group II had a pain score less than 3 (Figure 1). 4. Pulmonary function tests were done 24 hours after surgery and revealed improved values of all parameters in Group II patients. This indicates a greater degree of analgesia in Group II patients. 5. Preoperative administration of the drug reduces the initiation of pain in the periphery and decreases the inflammatory response after surgery. 6. NSAIDS do not have any central effect or any respiratory depression. Patients in our study were found to be awake, cooperative and pain free. The additional analgesia conferred by preoperative administration in conjunction with adequate postoperative therapy allows us to recommend Diclofenac sodium as a sole analgesic for perioperative pain relief except in those patients with a bleeding diathesis.",1994,Pain scoring using visual analogue scale indicated a better pain relief in Group II patients.,"['patients with a bleeding diathesis', 'Group II patients']","['diclofenac sodium', 'narcotic premedication', 'Diclofenac sodium']","['inflammatory response', 'initiation of pain', 'pain score', 'pain relief', 'Pulmonary function tests']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1458140', 'cui_str': 'Tendency to bleed (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0700583', 'cui_str': 'Diclofenac Sodium'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}]","[{'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}]",,0.0160196,Pain scoring using visual analogue scale indicated a better pain relief in Group II patients.,"[{'ForeName': '', 'Initials': '', 'LastName': 'Chandralekha', 'Affiliation': 'Department of Anaesthesiology A.I.I.M.S., New Delhi.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Bhalotra', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Saksena', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1852,32268000,A Single and Multiple Ascending Dose Study of Toll-Like Receptor 7 Agonist (RO7020531) in Chinese Healthy Volunteers.,"Toll-like receptor 7 (TLR7) agonists modulate broad spectrum immune activity and are evaluated in the treatment of human diseases, including cancer and chronic viral infection. RO7020531, an oral prodrug of a TLR7 agonist, is in clinical development as part of a curative regimen against chronic hepatitis B. We report the safety, tolerability, pharmacokinetics (PKs), and pharmacodynamics (PDs) of RO7020531 in healthy Chinese volunteers following single and multiple ascending doses (SAD and MAD). PK and PD samples were evaluated from four SAD cohorts and 3 MAD cohorts with 10 subjects each (8 active and 2 placebo). Safety and tolerability were monitored throughout the study. A total of 155 adverse events (AEs) were reported in 49 subjects. Fifty-one AEs in 18 subjects were assessed as treatment-related. Most of the AEs were mild; nine subjects experienced moderate AEs; there were no severe AEs. In two 150 mg MAD cohorts given every other day (q.o.d.), 7 of 20 subjects experienced pyrexia and were discontinued due to transient asymptomatic lymphopenia, which resolved 24-48 hours postdose. The PK of the active metabolite, RO7011785, increased linearly with dose from 40 mg to 170 mg. There was no PK accumulation following q.o.d. dosing. The PK profile is consistent with observations in white subjects in the global first-in-human study. SADs and MADs of RO7020531 resulted in dose-dependent increases in TLR7 response markers at 100 mg or above. Flu-like symptoms were associated with higher interferon-α levels. RO7020531 was safe and acceptably tolerated in healthy Chinese volunteers with a multiple 150 mg q.o.d. dose regimen.",2020,Single and multiple doses of RO7020531 resulted in dose-dependent increases in TLR7 response markers at 100mg or above.,"['Chinese healthy volunteers', 'Chinese healthy volunteers following single and multiple ascending doses (SAD & MAD', 'Chinese Healthy Volunteers']","['Toll', 'Like Receptor 7 (TLR 7) Agonist (RO7020531', 'RO7020531', 'TLR7 agonist', 'TLR7']","['TLR7 response markers', 'Safety and tolerability', 'safe and acceptably tolerated', 'PK accumulation', 'safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}]","[{'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0971207', 'cui_str': 'TLR7 protein, human'}]","[{'cui': 'C0971207', 'cui_str': 'TLR7 protein, human'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]",18.0,0.0606734,Single and multiple doses of RO7020531 resulted in dose-dependent increases in TLR7 response markers at 100mg or above.,"[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Luk', 'Affiliation': 'Phase 1 Clinical Trial Centre, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Qiudi', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Roche Innovation Center Shanghai, Shanghai, China.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Glavini', 'Affiliation': 'Roche Innovation Center Basel, Basel, Switzerland.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Triyatni', 'Affiliation': 'Roche Innovation Center Basel, Basel, Switzerland.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Roche Pharma Development Shanghai, Shanghai, China.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Racek', 'Affiliation': 'Roche Innovation Center Basel, Basel, Switzerland.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Roche Innovation Center Shanghai, Shanghai, China.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Grippo', 'Affiliation': 'Roche Innovation Center New York, New York, New York, USA.'}]",Clinical and translational science,['10.1111/cts.12791']
1853,25348221,Acute kidney injury after cardiac surgery: is minocycline protective?,"BACKGROUND AND OBJECTIVES


Acute kidney injury (AKI) after cardiac bypass surgery (CABG) is common and carries a significant association with morbidity and mortality. Since minocycline therapy attenuates kidney injury in animal models of AKI, we tested its effects in patients undergoing CABG.
DESIGN, SETTING, PARTICIPANTS AND MEASUREMENTS


This is a randomized, double-blinded, placebo-controlled, multi-center study. We screened high risk patients who were scheduled to undergo CABG in two medical centers between Jan 2008 and June 2011. 40 patients were randomized and 19 patients in each group completed the study. Minocycline prophylaxis was given twice daily, at least for four doses prior to CABG. Primary outcome was defined as AKI [0.3 mg/dl increase in creatinine (Cr)] within 5 days after surgery. Daily serum Cr for 5 days, various clinical and hemodynamic measures and length of stay were recorded.
RESULTS


The two groups had similar baseline and intra-operative characteristics. The primary outcome occurred in 52.6% of patients in the minocycline group as compared to 36.8% of patients in the placebo group (p = 0.51). Peak Cr was 1.6 ± 0.7 vs. 1.5 ± 0.7 mg/dl (p = 0.45) in minocycline and placebo groups, respectively. Death at 30 days occurred in 0 vs. 10.5% in the minocycline and placebo groups, respectively (p = 0.48). There were no differences in post-operative length of stay, and cardiovascular events between the two groups. There was a trend towards lower diastolic pulmonary artery pressure [16.8 ± 4.7 vs. 20.7 ± 6.6 mmHg (p = 0.059)] and central venous pressure [11.8 ± 4.3 vs. 14.6 ± 5.6 mmHg (p = 0.13)] in the minocycline group compared to placebo on the first day after surgery.
CONCLUSIONS


Minocycline did not protect against AKI post-CABG.",2015,"There were no differences in post-operative length of stay, and cardiovascular events between the two groups.","['patients undergoing CABG', 'high risk patients who were scheduled to undergo CABG in two medical centers between Jan 2008 and June 2011', '40 patients were randomized and 19 patients in each group completed the study', 'Acute kidney injury after cardiac surgery']","['placebo', 'Minocycline prophylaxis', 'cardiac bypass surgery (CABG', 'minocycline therapy', 'minocycline', 'Minocycline']","['Death', 'post-operative length of stay, and cardiovascular events', 'Daily serum Cr for 5 days, various clinical and hemodynamic measures and length of stay', 'central venous pressure', 'diastolic pulmonary artery pressure', 'AKI [0.3 mg/dl increase in creatinine (Cr']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C1536078', 'cui_str': 'Bypass surgery'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0428640', 'cui_str': 'Central venous pressure (observable entity)'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure (observable entity)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",40.0,0.545288,"There were no differences in post-operative length of stay, and cardiovascular events between the two groups.","[{'ForeName': 'Ladan', 'Initials': 'L', 'LastName': 'Golestaneh', 'Affiliation': 'Montefiore Medical Center, Albert Einstein Medical Center, 3411 Wayne Ave, Suite 5H, Bronx, NY, 10467, USA, lgolesta@montefiore.org.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Lindsey', 'Affiliation': ''}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Malhotra', 'Affiliation': ''}, {'ForeName': 'Faraj', 'Initials': 'F', 'LastName': 'Kargoli', 'Affiliation': ''}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Farkas', 'Affiliation': ''}, {'ForeName': 'Hendrick', 'Initials': 'H', 'LastName': 'Barner', 'Affiliation': ''}, {'ForeName': 'Rizwan', 'Initials': 'R', 'LastName': 'Qazi', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Schmidt', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rauchman', 'Affiliation': ''}, {'ForeName': 'Ziyad', 'Initials': 'Z', 'LastName': 'Al-Aly', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Dagher', 'Affiliation': ''}, {'ForeName': 'Allon', 'Initials': 'A', 'LastName': 'Friedman', 'Affiliation': ''}, {'ForeName': 'Tarek M', 'Initials': 'TM', 'LastName': 'El-Achkar', 'Affiliation': ''}]",Journal of nephrology,['10.1007/s40620-014-0152-2']
1854,7558212,Influence of intraumbilical oxytocin on the third stage of labour.,"In this study the effect of intraumbilical oxytocin on duration and amount of blood loss in third stage of labour was studied. Pregnant women were randomized into 2 groups of 50 each. Group I <study group> was managed actively with 10 units of oxytocin diluted in 20 ml saline given through umbilical vein immediately after cord claming and Group II <control group> managed traditionally with oxytocin infusion 10 units in 250 ml of dexrose saline at rate of 125 ml/hr given after delivery of baby. In the study group there was a statistically significant decrease in duration of third stage of labour <1.48 min vs 3.27 min>, fall in haemoglobin <1.2 g/dl vs 1.96 g/dl> and fall in haematocrit <3.88% Vs 7.20%<. It was concluded that intraumbilical oxytocin appears to be a useful, safe and practical method for active management of third stage.",1995,"In the study group there was a statistically significant decrease in duration of third stage of labour <1.48 min vs 3.27 min>, fall in haemoglobin",['Pregnant women'],"['oxytocin diluted in 20 ml saline given through umbilical vein immediately after cord claming and Group II <control group> managed traditionally with oxytocin infusion 10 units in 250 ml of dexrose saline', 'intraumbilical oxytocin']","['duration and amount of blood loss', 'haemoglobin', 'duration of third stage of labour']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0221313', 'cui_str': 'Fetal umbilical vein structure'}, {'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0474482', 'cui_str': 'Duration of third stage of labor (observable entity)'}]",,0.168823,"In the study group there was a statistically significant decrease in duration of third stage of labour <1.48 min vs 3.27 min>, fall in haemoglobin","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Dahiya', 'Affiliation': 'Department of Obstetrics and Gynaecology, Medical College and Hospital Rohtak.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Puri', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rathee', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1855,31419272,Effects of sertraline in the prevention of low blood pressure in patients undergoing hemodialysis.,"INTRODUCTION


Intradialytic hypotension (IDH) is a major complication of hemodialysis, with a prevalence of about 25% during hemodialysis sessions, causing increased morbidity and mortality.
OBJECTIVE


To study the effects of sertraline to prevent IDH in hemodialysis patients.
METHODS


This was a double-blind, crossover clinical trial comparing the use of sertraline versus placebo to reduce intradialytic hypotension.
RESULTS


Sixteen patients completed the two phases of the study during a 12-week period. The IDH prevalence was 32%. A comparison between intradialytic interventions, intradialytic symptoms, and IDH episodes revealed no statistical difference in the reduction of IDH episodes (p = 0.207) between the two intervention groups. However, the risk of IDH interventions was 60% higher in the placebo group compared to the sertraline group, and the risk of IDH symptoms was 40% higher in the placebo group compared to the sertraline group. Survival analysis using Kaplan-Meier estimator supported the results of this study. Sertraline presented a number needed to treat (NNT) of 16.3 patients to prevent an episode from IDH intervention and 14.2 patients to prevent an episode from intradialytic symptoms.
CONCLUSION


This study suggests that the use of sertraline may be beneficial to reduce the number of symptoms and ID interventions, although there was no statistically significant difference in the blood pressure levels.",2019,"However, the risk of IDH interventions was 60% higher in the placebo group compared to the sertraline group, and the risk of IDH symptoms was 40% higher in the placebo group compared to the sertraline group.","['hemodialysis patients', 'patients undergoing hemodialysis', 'Sixteen patients completed the two phases of the study during a 12-week period']","['sertraline', 'placebo', 'Sertraline']","['blood pressure levels', 'number needed to treat (NNT', 'IDH prevalence', 'IDH episodes', 'risk of IDH interventions', 'low blood pressure', 'risk of IDH symptoms']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.11721,"However, the risk of IDH interventions was 60% higher in the placebo group compared to the sertraline group, and the risk of IDH symptoms was 40% higher in the placebo group compared to the sertraline group.","[{'ForeName': 'Christine Zomer Zomer Dal', 'Initials': 'CZZD', 'LastName': 'Molin', 'Affiliation': 'Universidade do Sul de Santa Catarina, Tubarão, SC, Brasil.'}, {'ForeName': 'Thiago Mamoru', 'Initials': 'TM', 'LastName': 'Sakae', 'Affiliation': 'Universidade do Sul de Santa Catarina, Tubarão, SC, Brasil.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Schuelter-Trevisol', 'Affiliation': 'Universidade do Sul de Santa Catarina, Tubarão, SC, Brasil.'}, {'ForeName': 'Daisson Jose', 'Initials': 'DJ', 'LastName': 'Trevisol', 'Affiliation': 'Universidade do Sul de Santa Catarina, Tubarão, SC, Brasil.'}]",Jornal brasileiro de nefrologia : 'orgao oficial de Sociedades Brasileira e Latino-Americana de Nefrologia,['10.1590/2175-8239-JBN-2018-0189']
1856,31303298,"Post-partum family planning in Burkina Faso (Yam Daabo): a two group, multi-intervention, single-blinded, cluster-randomised controlled trial.","BACKGROUND


Post-partum family planning services can prevent maternal and child morbidity and mortality in low-resource settings. We assessed the effect of a family planning intervention package on modern contraceptive use at 12 months post partum in predominantly rural Burkina Faso.
METHODS


Yam Daabo was a two group, multi-intervention, single-blinded, cluster randomised controlled trial. Primary health-care centres were randomly allocated to intervention or control clusters in a 1:1 ratio with only data analysts masked to the allocation assignment. Interventions comprised refresher training for the provider, a counselling tool, supportive supervision, availability of contraceptive services 7 days a week, client appointment cards, and invitation letters for partners. The primary outcome was modern contraceptive prevalence at 12 months, and secondary outcomes were modern contraceptive prevalence at 6 weeks and 6 months post partum. Analysis was by modified intention to treat. Prevalence ratios were adjusted for cluster effects and baseline characteristics. This study was registered with the Pan-African Clinical Trials Registry (PACTR201609001784334).
FINDINGS


From July 27-Oct 17, 2016, eight clinics were randomised and 571 women were enrolled and allocated: 286 to four intervention clusters and 285 to four control clusters. Of these, 523 completed the 12-month study exit interview (260 in the intervention group, 263 in the control group) and 523 were included in the intention-to-treat analysis. At 12 months, modern contraceptive prevalence was 55% among women who received the package and 29% among those who received routine care in control clusters (adjusted prevalence ratio 1·79, 95% CI 1·30-2·47). Significant differences in modern contraceptive prevalence were also seen between intervention and control groups at 6 weeks (42% and 10%, respectively; adjusted prevalence ratio 3·88, 95% CI 1·46-10·35) and 6 months (59% and 24%, respectively; 2·31, 1·44-3·71).
INTERPRETATION


A package of six low-technology interventions, aimed at strengthening existing primary health-care services and enhancing demand for these services, can effectively increase modern contraceptive use for up to a year post partum in rural settings in Burkina Faso and has the potential to be suitable in similar settings in this country and others.
FUNDING


Government of France.",2019,"Significant differences in modern contraceptive prevalence were also seen between intervention and control groups at 6 weeks (42% and 10%, respectively; adjusted prevalence ratio 3·88, 95% CI 1·46-10·35) and 6 months (59% and 24%, respectively; 2·31, 1·44-3·71).
","['modern contraceptive use at 12 months post partum in predominantly rural Burkina Faso', 'Primary health-care centres', '523 completed the 12-month study exit interview (260 in the intervention group, 263 in the control group) and 523 were included in the intention-to-treat analysis', 'From July 27-Oct 17, 2016, eight clinics were randomised and 571 women were enrolled and allocated: 286 to four intervention clusters and 285 to four control clusters']","['family planning intervention package', 'intervention or control clusters in a 1:1 ratio with only data analysts masked to the allocation assignment']","['modern contraceptive prevalence', 'Prevalence ratios']","[{'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0337094', 'cui_str': 'Exit (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",523.0,0.217153,"Significant differences in modern contraceptive prevalence were also seen between intervention and control groups at 6 weeks (42% and 10%, respectively; adjusted prevalence ratio 3·88, 95% CI 1·46-10·35) and 6 months (59% and 24%, respectively; 2·31, 1·44-3·71).
","[{'ForeName': 'Nguyen Toan', 'Initials': 'NT', 'LastName': 'Tran', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland; Australian Centre for Public and Population Health Research, Faculty of Health, University of Technology, Sydney, Australia. Electronic address: nguyen-toan.tran@unige.ch.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Seuc', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Abou', 'Initials': 'A', 'LastName': 'Coulibaly', 'Affiliation': 'Institut de Recherche en Sciences de la Santé and Institut Africain de Santé Publique, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Sihem', 'Initials': 'S', 'LastName': 'Landoulsi', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Tieba', 'Initials': 'T', 'LastName': 'Millogo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé and Institut Africain de Santé Publique, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Fatou', 'Initials': 'F', 'LastName': 'Sissoko', 'Affiliation': 'Institut de Recherche en Sciences de la Santé and Institut Africain de Santé Publique, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Wambi Maurice E', 'Initials': 'WME', 'LastName': 'Yameogo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé and Institut Africain de Santé Publique, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Souleymane', 'Initials': 'S', 'LastName': 'Zan', 'Affiliation': 'World Health Organization Country Office in Burkina Faso, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Asa', 'Initials': 'A', 'LastName': 'Cuzin-Kihl', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kiarie', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Mary Eluned', 'Initials': 'ME', 'LastName': 'Gaffield', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Blandine', 'Initials': 'B', 'LastName': 'Thieba', 'Affiliation': 'Unité de Formation et de Recherche en Sciences de la Santé, Ouagadougou University, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Seni', 'Initials': 'S', 'LastName': 'Kouanda', 'Affiliation': 'Institut de Recherche en Sciences de la Santé and Institut Africain de Santé Publique, Ouagadougou, Burkina Faso.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30202-5']
1857,32130178,A Theoretically Based Mobile App to Increase Pre-Exposure Prophylaxis Uptake Among Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.,"BACKGROUND


HealthMindr is a mobile phone HIV prevention app for men who have sex with men (MSM). In a previous pilot study, HealthMindr was found to be acceptable among users and to demonstrate preliminary effectiveness for increasing pre-exposure prophylaxis (PrEP) uptake among MSM. PrEP is a highly effective HIV prevention intervention; however, uptake remains low.
OBJECTIVE


The aim of this study will be to assess the efficacy of a mobile app for increasing PrEP uptake among MSM in the southern United States.
METHODS


In this randomized controlled trial, we will assess the efficacy of HealthMindr for increasing PrEP uptake among MSM in the following three southern US cities: Atlanta, Georgia; Jackson, Mississippi; and Washington, DC. In total, 657 men will be recruited and randomized to intervention and control arms in a 2:1 ratio. Participants in the intervention arm will receive access to the full HealthMindr app, with information and resources about PrEP (eg, frequently asked questions, risk assessment tool, and PrEP provider locator), other HIV prevention information, ability to order free HIV/sexually transmitted infection test kits, and additional resources related to substance use and mental health. Participants in the control arm will use the HealthMindr app but will only have access to the study timeline and a message center to communicate with study staff. Participants will complete quarterly surveys to assess self-reported PrEP uptake over 12 months of follow-up. Self-reported PrEP uptake will be verified by dried blood spot testing and/or uploading a photograph of a PrEP prescription.
RESULTS


Participant recruitment began in January 2020.
CONCLUSIONS


This trial will determine whether the HealthMindr app can increase PrEP uptake among MSM in the southern United States.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03763942; https://clinicaltrials.gov/ct2/show/NCT03763942.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/16231.",2020,"In a previous pilot study, HealthMindr was found to be acceptable among users and to demonstrate preliminary effectiveness for increasing pre-exposure prophylaxis (PrEP) uptake among MSM.","['men who have sex with men (MSM', 'southern United States', 'three southern US cities', 'Participant recruitment began in January 2020', 'Men', '657 men']","['PrEP', 'full HealthMindr app, with information and resources about PrEP (eg, frequently asked questions, risk assessment tool, and PrEP provider locator), other HIV prevention information, ability to order free HIV/sexually transmitted infection test kits, and additional resources related to substance use and mental health', 'HealthMindr']","['Increase Pre-Exposure Prophylaxis Uptake', 'PrEP uptake']","[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0566217', 'cui_str': 'Does ask questions (finding)'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment (procedure)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]",657.0,0.20504,"In a previous pilot study, HealthMindr was found to be acceptable among users and to demonstrate preliminary effectiveness for increasing pre-exposure prophylaxis (PrEP) uptake among MSM.","[{'ForeName': 'Jeb', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Dominguez', 'Affiliation': 'Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Stephenson', 'Affiliation': 'Department of Systems, Populations and Leadership, School of Nursing, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Joanne D', 'Initials': 'JD', 'LastName': 'Stekler', 'Affiliation': 'Division of Allergy & Infectious Diseases, School of Medicine, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Amanda D', 'Initials': 'AD', 'LastName': 'Castel', 'Affiliation': 'Department of Epidemiology and Biostatistics, Milken Institute School of Public Health, The George Washington University, Washington, DC, United States.'}, {'ForeName': 'Leandro A', 'Initials': 'LA', 'LastName': 'Mena', 'Affiliation': 'Department of Population Health Science, John D Bower School of Population Health, University of Mississippi Medical Center, Jackson, MS, United States.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Jenness', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Aaron J', 'Initials': 'AJ', 'LastName': 'Siegler', 'Affiliation': 'Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Sullivan', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}]",JMIR research protocols,['10.2196/16231']
1858,31800798,Use of health services by elderly people post-stroke: a randomized controlled trial.,"AIM


To verify the relation of a nursing home care educational intervention in the use of health services by elderly people post-stroke.
METHODS


A randomized controlled trial conducted with 44 family caregivers of elderly people post-stroke. Data was collected between May/2016 and July/2018 in a hospital in the South of Brazil and at the participants' homes. The intervention group (IG=21) received home visits by nurses after hospital discharge. The control group (CG=23) had a conventional follow-up in a conventional health services. The Pearson's Chi-Square Test or the Fisher's Exact Test was performed for assessment of the outcome at 60 days and 1 year after discharge. Clinical Trial registration NCT02807012.
RESULTS


There was a significant difference regarding the use of hospital outpatient service (IG=100%, CG=78.3%, p<0.050) 60 days after discharge.
CONCLUSION


The great use of outpatient service by the IG demonstrates the effectiveness of nursing educational intervention focused on health care network after discharge.",2020,"There was a significant difference regarding the use of hospital outpatient service (IG=100%, CG=78.3%, p<0.050) 60 days after discharge.
","['elderly people post-stroke', '44 family caregivers of elderly people post-stroke']","['conventional follow-up in a conventional health services', 'health services', 'nursing educational intervention', 'nursing home care educational intervention']",['hospital outpatient service'],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0086751', 'cui_str': 'Outpatient Services'}]",,0.18783,"There was a significant difference regarding the use of hospital outpatient service (IG=100%, CG=78.3%, p<0.050) 60 days after discharge.
","[{'ForeName': 'Carla Cristiane Becker Kottwitz', 'Initials': 'CCBK', 'LastName': 'Bierhals', 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Escola de Enfermagem, Programa de Pós-Graduação em Enfermagem. Porto Alegre, Rio Grande do Sul, Brasil.'}, {'ForeName': 'Carolina Baltar', 'Initials': 'CB', 'LastName': 'Day', 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Escola de Enfermagem, Programa de Pós-Graduação em Enfermagem. Porto Alegre, Rio Grande do Sul, Brasil.'}, {'ForeName': 'Duane', 'Initials': 'D', 'LastName': 'Mocellin', 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Escola de Enfermagem. Porto Alegre, Rio Grande do Sul, Brasil.'}, {'ForeName': 'Naiana Oliveira Dos', 'Initials': 'NOD', 'LastName': 'Santos', 'Affiliation': 'Universidade Franciscana (UFN). Santa Maria, Rio Grande do Sul, Brasil.'}, {'ForeName': 'Mariane Lurdes', 'Initials': 'ML', 'LastName': 'Predebon', 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Escola de Enfermagem, Programa de Pós-Graduação em Enfermagem. Porto Alegre, Rio Grande do Sul, Brasil.'}, {'ForeName': 'Fernanda Laís Fengler Dal', 'Initials': 'FLFD', 'LastName': 'Pizzol', 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Escola de Enfermagem, Programa de Pós-Graduação em Enfermagem. Porto Alegre, Rio Grande do Sul, Brasil.'}, {'ForeName': 'Ana Cláudia', 'Initials': 'AC', 'LastName': 'Fuhrmann', 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Escola de Enfermagem, Programa de Pós-Graduação em Enfermagem. Porto Alegre, Rio Grande do Sul, Brasil.'}, {'ForeName': 'Giullia Garcia de', 'Initials': 'GG', 'LastName': 'Medeiros', 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Escola de Enfermagem. Porto Alegre, Rio Grande do Sul, Brasil.'}, {'ForeName': 'Marines', 'Initials': 'M', 'LastName': 'Aires', 'Affiliation': 'Universidade Integrada do Alto Uruguai e Missões (URI). Frederico Westphalen, Rio Grande do Sul, Brasil.'}, {'ForeName': 'Lisiane Manganelli Girardi', 'Initials': 'LMG', 'LastName': 'Paskulin', 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Escola de Enfermagem, Programa de Pós-Graduação em Enfermagem. Porto Alegre, Rio Grande do Sul, Brasil.'}]",Revista gaucha de enfermagem,['10.1590/1983-1447.2020.20190138']
1859,31801514,Maternal nutritional adequacy and gestational weight gain and their associations with birth outcomes among Vietnamese women.,"BACKGROUND


During pregnancy, a mother's nutritional needs increase to meet the added nutrient demands for fetal growth and development. An enhanced understanding of adequate nutrition and sufficient weight gain during pregnancy can guide development of policies and strategies for maternal nutrition care, actions that will ultimately promote better pregnancy outcomes. In a sample of pregnant women in Vietnam, this study characterized maternal nutrition status and gestational weight gain at a mid-pregnancy baseline, then examined the association of these variables with specific birth outcomes.
METHODS


The study used baseline data from a randomized, controlled trial that compared pregnant Vietnamese women who received a nutritional intervention group with those who received only standard dietary counseling (control group). At baseline (26-29 weeks gestation), mothers' dietary reports were collected, and intake of 10 macro- and micronutrients was estimated; data for baseline gestational weight gain was collected for all pregnant women enrolled into the study (n = 228). This analysis also used weights, lengths, and head circumferences at birth for infants of mothers in the control group.
RESULTS


At baseline, 95% of the pregnant women had concurrent inadequacies for more than five nutrients, and nearly half had concurrent inadequacies for more than ten nutrients. Almost two-thirds of the pregnant women did not meet recommendations for gestational weight gain. We found a significant, inverse association between the number of nutrient inadequacies and gestational weight gain (overall p ≤ 0.045). After adjusting for potential confounders, gestational weight gain was positively associated with birth weight, length at birth, birth weight-for-age z-score and length-for-age z-score (all p ≤ 0.006).
CONCLUSIONS


Our findings raise concern over the high proportion of pregnant women in Vietnam who have multiple concurrent nutrient inadequacies and who fall short of meeting recommended gestational weight gain standards. To ensure better birth outcomes in this population, policies and strategies to improve the status of maternal nutrition are greatly needed.
TRIAL REGISTRATION


The trial was retrospectively registered at clinicaltrials.gov on December 20, 2013, registration identifier: NCT02016586.",2019,"We found a significant, inverse association between the number of nutrient inadequacies and gestational weight gain (overall p ≤ 0.045).","['pregnant women in Vietnam', 'pregnant women enrolled into the study (n\u2009=\u2009228', 'Vietnamese women', 'pregnant women in Vietnam who have multiple concurrent nutrient inadequacies and who fall short of meeting recommended gestational weight gain standards', 'pregnant Vietnamese women who received a']",['nutritional intervention group with those who received only standard dietary counseling (control group'],"['Maternal nutritional adequacy and gestational weight gain', 'baseline gestational weight gain', 'maternal nutrition status and gestational weight gain', 'number of nutrient inadequacies and gestational weight gain', 'birth weight, length at birth, birth weight-for-age z-score and length-for-age z-score', 'gestational weight gain']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1561452', 'cui_str': 'Vietnamese'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0419415', 'cui_str': 'Birth length (observable entity)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",,0.154084,"We found a significant, inverse association between the number of nutrient inadequacies and gestational weight gain (overall p ≤ 0.045).","[{'ForeName': 'Nga Thuy', 'Initials': 'NT', 'LastName': 'Tran', 'Affiliation': 'Micronutrient Research and Application, National Institution of Nutrition, 48B Tang Ba Ho, Hai Ba Trung District, Ha Noi, Vietnam.'}, {'ForeName': 'Lam Thi', 'Initials': 'LT', 'LastName': 'Nguyen', 'Affiliation': 'Clinical Nutrition, National Institution of Nutrition, 48B Tang Ba Ho, Hai Ba Trung District, Ha Noi, Vietnam.'}, {'ForeName': 'Yatin', 'Initials': 'Y', 'LastName': 'Berde', 'Affiliation': 'Statistical Services, Cognizant Technologies Solution Pvt. Ltd, Hiranandani Business Park, Mumbai, 400076, India.'}, {'ForeName': 'Yen Ling', 'Initials': 'YL', 'LastName': 'Low', 'Affiliation': 'Abbott Nutrition Research and Development Asia-Pacific Center, 20 Biopolis Way, Unit 09-01/02 Centros Building, Singapore, 138668, Singapore.'}, {'ForeName': 'Siew Ling', 'Initials': 'SL', 'LastName': 'Tey', 'Affiliation': 'Abbott Nutrition Research and Development Asia-Pacific Center, 20 Biopolis Way, Unit 09-01/02 Centros Building, Singapore, 138668, Singapore.'}, {'ForeName': 'Dieu Thi Thu', 'Initials': 'DTT', 'LastName': 'Huynh', 'Affiliation': 'Abbott Nutrition Research and Development Asia-Pacific Center, 20 Biopolis Way, Unit 09-01/02 Centros Building, Singapore, 138668, Singapore. dieu.huynh@abbott.com.'}]",BMC pregnancy and childbirth,['10.1186/s12884-019-2643-6']
1860,31116883,A Cluster Randomized Trial of Tai Chi vs Health Education in Subsidized Housing: The MI-WiSH Study.,"OBJECTIVES


Tai Chi (TC) may benefit older adults with a variety of diseases and disabilities. We tested the hypothesis that TC improves physical function in older adults living in low-income housing facilities.
DESIGN


Cluster randomized controlled trial.
SETTING


Subsidized housing facilities in Boston, Massachusetts, and neighboring communities.
PARTICIPANTS


Volunteers were recruited from 15 facilities. The 180 randomized participants were 60 years of age or older, able to understand English and participate in TC, expected to remain in the facility for 1 year, and able to walk independently.
INTERVENTION


TC classes were conducted in the housing facilities twice/week for 1 year and compared with monthly health promotion educational classes and social calls.
MEASUREMENTS


The primary outcome was physical function measured by the Short Physical Performance Battery (SPPB). Secondary outcomes included other aspects of physical and cognitive function, and falls.
RESULTS


An interim analysis revealed less improvement over 12 months in SPPB scores among TC participants (+.20 units; 95% confidence interval [CI] = -.20 to +.60; P = .69) vs control participants (+.51 units; 95% CI = +.15 to +.87; P = .007), a difference of -.31 units (95% CI = -.66 to .04; P = .082). This met the criterion for futility, and the Data Safety Monitoring Board recommended trial termination. No differences were found in 6- or 12-month changes favoring TC in any secondary outcomes or adverse events.
CONCLUSION


In older adults with multiple chronic conditions living in subsidized housing facilities, 6 and 12 months of twice/week TC classes were not associated with improvements in functional health. J Am Geriatr Soc 67:1812-1819, 2019.",2019,"vs control participants (+.51 units; 95% CI = +.15 to +.87; P = .007), a difference of -.31 units (95% CI = -.66 to .04; P = .082).","['Volunteers were recruited from 15 facilities', 'Subsidized housing facilities in Boston, Massachusetts, and neighboring communities', '180 randomized participants were\u200960\u2009years of age or older, able to understand English and participate in TC, expected to remain in the facility for 1 year, and able to walk independently', 'older adults with a variety of diseases and disabilities', 'older adults living in low-income housing facilities', 'older adults with multiple chronic conditions living in subsidized housing facilities', 'Subsidized Housing']","['TC', 'Tai Chi vs Health Education', 'Tai Chi (TC', 'monthly health promotion educational classes and social calls']","['physical function', 'adverse events', 'functional health', 'aspects of physical and cognitive function, and falls', 'physical function measured by the Short Physical Performance Battery (SPPB', 'SPPB scores']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C2712089', 'cui_str': 'Able to walk (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C3266262', 'cui_str': 'Multi'}]","[{'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0018701'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",180.0,0.124469,"vs control participants (+.51 units; 95% CI = +.15 to +.87; P = .007), a difference of -.31 units (95% CI = -.66 to .04; P = .082).","[{'ForeName': 'Lewis A', 'Initials': 'LA', 'LastName': 'Lipsitz', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife, Boston, Massachusetts.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Macklin', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Travison', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife, Boston, Massachusetts.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Manor', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife, Boston, Massachusetts.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Gagnon', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife, Boston, Massachusetts.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Tsai', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife, Boston, Massachusetts.'}, {'ForeName': 'Ilean Isaza', 'Initials': 'II', 'LastName': 'Aizpurúa', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife, Boston, Massachusetts.'}, {'ForeName': 'On-Yee', 'Initials': 'OY', 'LastName': 'Lo', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife, Boston, Massachusetts.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.15986']
1861,31116891,Effect of local infiltration with oxytocin on hemodynamic response to surgical incision and postoperative pain in patients having open laparoscopic surgery under general anesthesia.,"BACKGROUND


Preemptive analgesia encompasses different perioperative interventions that have the final aim of decreasing postoperative pain and improving recovery. Recently, peripheral analgesic effects of oxytocinergic modulation have been suggested. In this regard, we tested the potential analgesic effects of subcutaneous oxytocin (OT) infiltration in patients submitted to laparoscopic cholecystectomy.
METHODS


Thirty patients with similar general characteristics and medical physical conditions were evaluated. The patients were assigned by simple random selection to one of three groups: (a) OT group (n = 10), which received preincisional subcutaneous OT (4 µg/4 ml saline) in the surgical sites for trocar placements; (b) Lidocaine group (n = 10), which received subcutaneous lidocaine 1% (4 ml) in the surgical sites; and (c) Control group (n = 10), which did not receive any treatment. Then we measured the effect of those treatments on the hemodynamic variations produced as responses to the surgical incisions and trocar insertions (open port placements using the Hasson technique). Moreover, we assessed the intensity of postoperative pain with the visual analogue scale during recovery and 24 hr after surgery.
RESULTS


Hemodynamic parameters were stable in both intervention groups (subcutaneous OT and lidocaine) during the surgical incisions and trocar placements, whereas a most likely sympathetic activation due to trocar insertions (open port placements) was not blunted in the placebo group. Furthermore, postoperative pain was diminished in both OT and lidocaine groups when compared to the control group.
CONCLUSIONS


Preincisional subcutaneous OT administration reduced the hemodynamic response produced by the latter. Furthermore, OT also diminished postoperative pain.",2019,"RESULTS


Hemodynamic parameters were stable in both intervention groups (subcutaneous OT and lidocaine) during the surgical incisions and trocar placements, whereas a most likely sympathetic activation due to trocar insertions (open port placements) was not blunted in the placebo group.","['patients submitted to laparoscopic cholecystectomy', 'patients having open laparoscopic surgery under general anesthesia', 'Thirty patients with similar general characteristics and medical physical conditions were evaluated']","['Lidocaine', 'lidocaine', 'preincisional subcutaneous OT (4\xa0µg/4 ml saline', 'subcutaneous lidocaine', 'subcutaneous oxytocin (OT) infiltration', 'Preincisional subcutaneous OT', 'oxytocin']","['postoperative pain', 'hemodynamic response', 'intensity of postoperative pain with the visual analogue scale', 'sympathetic activation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",30.0,0.0233861,"RESULTS


Hemodynamic parameters were stable in both intervention groups (subcutaneous OT and lidocaine) during the surgical incisions and trocar placements, whereas a most likely sympathetic activation due to trocar insertions (open port placements) was not blunted in the placebo group.","[{'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Zayas-González', 'Affiliation': 'Departamento de Neurobiología del Desarrollo y Neurofisiología, Instituto de Neurobiología, Universidad Nacional Autónoma de México, Querétaro, México.'}, {'ForeName': 'Abimael', 'Initials': 'A', 'LastName': 'González-Hernández', 'Affiliation': 'Departamento de Neurobiología del Desarrollo y Neurofisiología, Instituto de Neurobiología, Universidad Nacional Autónoma de México, Querétaro, México.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Manzano-García', 'Affiliation': 'Departamento de Neurobiología del Desarrollo y Neurofisiología, Instituto de Neurobiología, Universidad Nacional Autónoma de México, Querétaro, México.'}, {'ForeName': 'Donaciano', 'Initials': 'D', 'LastName': 'Hernández-Rivero', 'Affiliation': 'Hospital Regional de Petróleos Mexicanos, Salamanca, México.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'García-Cuevas', 'Affiliation': 'Hospital Regional de Petróleos Mexicanos, Salamanca, México.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Granados-Mortera', 'Affiliation': 'Hospital Regional de Petróleos Mexicanos, Salamanca, México.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Vaca-Aguirre', 'Affiliation': 'Hospital Regional de Petróleos Mexicanos, Salamanca, México.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Flores-Fierro', 'Affiliation': 'Hospital Regional de Petróleos Mexicanos, Salamanca, México.'}, {'ForeName': 'Guadalupe', 'Initials': 'G', 'LastName': 'Martínez-Lorenzana', 'Affiliation': 'Instituto de Neurobiología, Universidad Nacional Autónoma de México, Querétaro, México.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Condés-Lara', 'Affiliation': 'Departamento de Neurobiología del Desarrollo y Neurofisiología, Instituto de Neurobiología, Universidad Nacional Autónoma de México, Querétaro, México.'}]","European journal of pain (London, England)",['10.1002/ejp.1427']
1862,31944804,"Use of common and unique techniques in the early treatment phase for cognitive-behavioral, interpersonal/emotional, and supportive listening interventions for generalized anxiety disorder.","Psychotherapy research often compares specific treatments to control conditions to establish efficacy of the specified treatment. Research has typically evaluated common factor elements (e.g., credibility, expectancy) in treatments only after the first or second session, largely as a manipulation check and under the assumption that such factors are static. This study observed therapist common factor and model-specific interventions in three treatment approaches from a randomized control trial for generalized anxiety disorder across the entire early phase of treatment (i.e., first five sessions). The parent randomized control trial compared two treatment conditions, using an additive design where patients were randomized to receive either interpersonal/emotional processing interventions or supportive listening after receiving a session of cognitive-behavioral therapy. The first five video-recorded sessions of  N  = 40 randomly sampled participants were observationally coded with a multidimensional intervention measure, with subscales reflecting diverse theoretical orientations and common factors. Multilevel modeling was used to examine intervention use and investigate differences between treatment conditions and segments. Among the results, common factor interventions were rated as significantly more typical in cognitive-behavioral therapy compared with supportive listening. The pattern of intervention use of other subscales was generally consistent with the orientation of the respective protocols. In the early phase of treatment, supportive listening conditions do not appear to function as common factor controls in the manner that many might assume. Common factors are potentially enhanced in bona fide treatments that include a more detailed, specific rationale and clear and cohesive techniques and goals. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,"Among the results, common factor interventions were rated as significantly more typical in cognitive-behavioral therapy compared with supportive listening.",['generalized anxiety disorder'],"['therapist common factor and model-specific interventions', 'interpersonal/emotional processing interventions or supportive listening after receiving a session of cognitive-behavioral therapy']",[],"[{'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder (disorder)'}]","[{'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]",[],2020.0,0.0256031,"Among the results, common factor interventions were rated as significantly more typical in cognitive-behavioral therapy compared with supportive listening.","[{'ForeName': 'Brittany R', 'Initials': 'BR', 'LastName': 'King', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Boswell', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Carly M', 'Initials': 'CM', 'LastName': 'Schwartzman', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Kyler', 'Initials': 'K', 'LastName': 'Lehrbach', 'Affiliation': 'Department of Emergency Medicine.'}, {'ForeName': 'Louis G', 'Initials': 'LG', 'LastName': 'Castonguay', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Newman', 'Affiliation': 'Department of Psychology.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000277']
1863,31323455,Financial strain and ideal cardiovascular health in middle-aged and older women: Data from the Women's health study.,"Financial strain is a prevalent form of psychosocial stress in the United States; however, information about the relationship between financial strain and cardiovascular health remains sparse, particularly in older women.
METHODS


The cross-sectional association between financial strain and ideal cardiovascular health were examined in the Women's Health Study follow-up cohort (N = 22,048; mean age = 72± 6.0 years).Six self-reported measures of financial strain were summed together to create a financial strain index and categorized into 4 groups: No financial strain, 1 stressor, 2 stressors, and 3+ stressors. Ideal cardiovascular health was based on the American Heart Association strategic 2020 goals metric, including tobacco use, body mass index, physical activity, diet, blood pressure, total cholesterol and diabetes mellitus. Cardiovascular health was examined as continuous and a categorical outcome (ideal, intermediate, and poor). Statistical analyses adjusted for age, race/ethnicity, education and income.
RESULTS


At least one indicator of financial strain was reported by 16% of participants. Number of financial stressors was associated with lower ideal cardiovascular health, and this association persisted after adjustment for potential confounders (1 financial stressor (FS): B = -0.10, 95% Confidence Intervals (CI) = -0.13, -0.07; 2 FS: B = -0.20, 95% CI = -0.26, -0.15; 3+ FS: B = -0.44, 95% CI = -0.50, -0.38).
CONCLUSION


Financial strain was associated with lower ideal cardiovascular health in middle aged and older female health professional women. The results of this study have implications for the potential cardiovascular health benefit of financial protections for older individuals.",2019,"Number of financial stressors was associated with lower ideal cardiovascular health, and this association persisted after adjustment for potential confounders (1 financial stressor (FS): B = -0.10, 95% Confidence Intervals (CI) = -0.13, -0.07; 2 FS: B = -0.20, 95% CI = -0.26, -0.15; 3+ FS: B = -0.44, 95% CI = -0.50, -0.38).
","['older women', ""Women's Health Study follow-up cohort (N\u202f=\u202f22,048; mean age"", 'older individuals', 'middle aged and older female health professional women', 'middle-aged and older women']",[],"['financial strain', 'ideal cardiovascular health', 'Cardiovascular health', 'tobacco use, body mass index, physical activity, diet, blood pressure, total cholesterol and diabetes mellitus', 'Number of financial stressors']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0080339', 'cui_str': 'Womens Health'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],"[{'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",22048.0,0.0243079,"Number of financial stressors was associated with lower ideal cardiovascular health, and this association persisted after adjustment for potential confounders (1 financial stressor (FS): B = -0.10, 95% Confidence Intervals (CI) = -0.13, -0.07; 2 FS: B = -0.20, 95% CI = -0.26, -0.15; 3+ FS: B = -0.44, 95% CI = -0.50, -0.38).
","[{'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Cabeza de Baca', 'Affiliation': 'University of California San Francisco, Center for the Study of Adversity and Cardiovascular Disease (NURTURE Center), Division of Cardiology, Department of Medicine, San Francisco, CA. Electronic address: tdebaca@email.arizona.edu.'}, {'ForeName': 'Melissa S', 'Initials': 'MS', 'LastName': 'Burroughs Peña', 'Affiliation': 'University of California San Francisco, Center for the Study of Adversity and Cardiovascular Disease (NURTURE Center), Division of Cardiology, Department of Medicine, San Francisco, CA. Electronic address: melissaburroughspena@gmail.com.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Slopen', 'Affiliation': 'University of Maryland School of Public Health, Department of Epidemiology and Biostatistics, College Park, MD. Electronic address: nslopen@umd.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Williams', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Department of Social and Behavioral Sciences, Boston, MA. Electronic address: dwilliam@hsph.harvard.edu.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Buring', 'Affiliation': ""Harvard T. H. Chan School of Public Health, Department of Epidemiology, Boston, MA; Brigham and Women's Hospital, Division of Preventive Medicine, Department of Medicine, Boston, MA. Electronic address: jburing@rics.bwh.harvard.edu.""}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Albert', 'Affiliation': 'University of California San Francisco, Center for the Study of Adversity and Cardiovascular Disease (NURTURE Center), Division of Cardiology, Department of Medicine, San Francisco, CA. Electronic address: michelle.albert@ucsf.edu.'}]",American heart journal,['10.1016/j.ahj.2019.06.002']
1864,31419968,A combination intervention addressing sexual risk-taking behaviors among vulnerable women in Uganda: study protocol for a cluster randomized clinical trial.,"BACKGROUND


Sub-Saharan Africa (SSA) has the highest number of people living with HIV/AIDS, with Nigeria, South Africa, and Uganda accounting for 48% of new infections. A systematic review of the HIV burden among women engaged in sex work (WESW) in 50 low- and middle-income countries found that they had increased odds of HIV infection relative to the general female population. Social structural factors, such as the sex work environment, violence, stigma, cultural issues, and criminalization of sex work are critical in shaping sexually transmitted infection (STI)/HIV risks among WESW and their clients in Uganda. Poverty is the most commonly cited reason for involvement in sex work in SSA. Against this backdrop, this study protocol describes a randomized controlled trial (RCT) that tests the impact of adding economic empowerment to traditional HIV risk reduction (HIVRR) to reduce new incidence of STIs and HIV among WESW in Rakai and the greater Masaka regions in Uganda.
METHODS


This three-arm RCT will evaluate the efficacy of adding savings, financial literacy and vocational training/mentorship to traditional HIVRR on reducing new incidence of STI infections among 990 WESW across 33 hotspots. The three arms (n = 330 each) are: 1) Control group: only HIVRR versus 2) Treatment group 1: HIVRR plus Savings plus Financial Literacy (HIVRR + S + FL); and 3) Treatment group 2: HIVRR plus S plus FL plus Vocational Skills Training and Mentorship (V) (HIVRR + S + FL + V). Data will be collected at baseline (pre-test), 6, 12, 18 and 24-months post-intervention initiation. This study will use an embedded experimental mixed methods design where qualitative data will be collected post-intervention across all conditions to explore participant experiences.
DISCUSSION


When WESW have access to more capital and/or alternative forms of employment and start earning formal income outside of sex work, they may be better able to improve their skills and employability for professional advancement, thereby reducing their STI/HIV risk. The study findings may advance our understanding of how best to implement gender-specific HIV prevention globally, engaging women across the HIV treatment cascade. Further, results will provide evidence for the intervention's efficacy to reduce STIs and inform implementation sustainability, including costs and cost-effectiveness.
TRIAL REGISTRATION


ClinicalTrials.gov , ID: NCT03583541 .",2019,"Further, results will provide evidence for the intervention's efficacy to reduce STIs and inform implementation sustainability, including costs and cost-effectiveness.
","['vulnerable women in Uganda', 'women engaged in sex work (WESW) in 50 low- and middle-income countries found that they had increased odds of HIV infection relative to the general female population']","['economic empowerment to traditional HIV risk reduction (HIVRR', 'Control group: only HIVRR versus 2) Treatment group 1: HIVRR plus Savings plus Financial Literacy (HIVRR\xa0+\xa0S\u2009+\u2009FL); and 3) Treatment group 2: HIVRR plus S plus FL plus Vocational Skills Training and Mentorship (V) (HIVRR\xa0+\xa0S\u2009+\u2009FL\u2009+\u2009V']",['sexual risk-taking behaviors'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0033595', 'cui_str': 'Sex Industry'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0025370', 'cui_str': 'Mentorships'}]","[{'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",990.0,0.18682,"Further, results will provide evidence for the intervention's efficacy to reduce STIs and inform implementation sustainability, including costs and cost-effectiveness.
","[{'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Brown School, Washington University in St. Louis, Campus Box 1196, One Brookings Drive, St. Louis, MO, 63130, USA. fms1@wustl.edu.'}, {'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Sensoy Bahar', 'Affiliation': 'Brown School, Washington University in St. Louis, Campus Box 1196, One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Yesim', 'Initials': 'Y', 'LastName': 'Tozan', 'Affiliation': 'College of Global Public Health, New York University, New York City, NY, USA.'}, {'ForeName': 'Proscovia', 'Initials': 'P', 'LastName': 'Nabunya', 'Affiliation': 'Brown School, Washington University in St. Louis, Campus Box 1196, One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Larissa Jennings', 'Initials': 'LJ', 'LastName': 'Mayo-Wilson', 'Affiliation': 'Indiana University School of Public Health, Bloomington, IN, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Kiyingi', 'Affiliation': 'International Center for Child Health and Development, Masaka, Uganda.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Kagaayi', 'Affiliation': 'Rakai Health Sciences Program, Rakai, Uganda.'}, {'ForeName': 'Scarlett', 'Initials': 'S', 'LastName': 'Bellamy', 'Affiliation': 'Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McKay', 'Affiliation': 'Brown School, Washington University in St. Louis, Campus Box 1196, One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Witte', 'Affiliation': 'Columbia University School of Social Work, New York City, NY, USA.'}]",BMC women's health,['10.1186/s12905-019-0807-1']
1865,26588940,The Efficacy of Adapted MBCT on Core Symptoms and Executive Functioning in Adults With ADHD: A Preliminary Randomized Controlled Trial.,"OBJECTIVE


The aim of this study was to examine the effectiveness of mindfulness as a treatment for adults diagnosed with ADHD. A 12-week-adapted mindfulness-based cognitive therapy (MBCT) program is compared with a waiting list (WL) group.
METHOD


Adults with ADHD were randomly allocated to MBCT ( n = 55) or waitlist ( n = 48). Outcome measures included investigator-rated ADHD symptoms (primary), self-reported ADHD symptoms, executive functioning, depressive and anxiety symptoms, patient functioning, and mindfulness skills.
RESULTS


MBCT resulted in a significant reduction of ADHD symptoms, both investigator-rated and self-reported, based on per-protocol and intention-to-treat analyses. Significant improvements in executive functioning and mindfulness skills were found. Additional analyses suggested that the efficacy of MBCT in reducing ADHD symptoms and improving executive functioning is partially mediated by an increase in the mindfulness skill ""Act With Awareness."" No improvements were observed for depressive and anxiety symptoms, and patient functioning.
CONCLUSION


This study provides preliminary support for the effectiveness of MBCT for adults with ADHD.",2019,"No improvements were observed for depressive and anxiety symptoms, and patient functioning.
","['Adults with ADHD', 'adults with ADHD', 'adults diagnosed with ADHD', 'Adults With ADHD']","['Adapted MBCT', 'MBCT', 'adapted mindfulness-based cognitive therapy (MBCT) program']","['investigator-rated ADHD symptoms (primary), self-reported ADHD symptoms, executive functioning, depressive and anxiety symptoms, patient functioning, and mindfulness skills', 'depressive and anxiety symptoms, and patient functioning', 'Core Symptoms and Executive Functioning', 'ADHD symptoms and improving executive functioning', 'ADHD symptoms', 'executive functioning and mindfulness skills']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",,0.0674147,"No improvements were observed for depressive and anxiety symptoms, and patient functioning.
","[{'ForeName': 'Sevket', 'Initials': 'S', 'LastName': 'Hepark', 'Affiliation': '1 Radboud University Medical Center Nijmegen, The Netherlands.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Janssen', 'Affiliation': '1 Radboud University Medical Center Nijmegen, The Netherlands.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'de Vries', 'Affiliation': '2 University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Poppy L A', 'Initials': 'PLA', 'LastName': 'Schoenberg', 'Affiliation': '1 Radboud University Medical Center Nijmegen, The Netherlands.'}, {'ForeName': 'Rogier', 'Initials': 'R', 'LastName': 'Donders', 'Affiliation': '1 Radboud University Medical Center Nijmegen, The Netherlands.'}, {'ForeName': 'Cornelis C', 'Initials': 'CC', 'LastName': 'Kan', 'Affiliation': '1 Radboud University Medical Center Nijmegen, The Netherlands.'}, {'ForeName': 'Anne E M', 'Initials': 'AEM', 'LastName': 'Speckens', 'Affiliation': '1 Radboud University Medical Center Nijmegen, The Netherlands.'}]",Journal of attention disorders,['10.1177/1087054715613587']
1866,31326680,Design and rationale of a pragmatic trial integrating routine screening for atrial fibrillation at primary care visits: The VITAL-AF trial.,"Given the preventable morbidity and mortality associated with atrial fibrillation (AF), increased awareness of undiagnosed AF, and advances in mobile electrocardiogram (ECG) technology, there is a critical need to assess the effectiveness of using such technology to routinely screen for AF in clinical practice. VITAL-AF is a pragmatic trial that will test whether screening for AF using a single-lead handheld ECG in individuals 65 years or older during primary care visits will lead to an increased rate of AF detection. The study is a cluster-randomized trial, with 8 primary care practices randomized to AF screening and 8 primary care practices randomized to usual care. We anticipate studying approximately 16,000 patients in each arm. During the 1-year enrollment period, practice medical assistants will screen eligible patients who agree to participate during office visits using a single-lead ECG device. Automated screening results are documented in the electronic health record, and patients can discuss screening results with their provider during the scheduled visit. All single-lead ECGs are overread by a cardiologist. Screen-detected AF is managed at the discretion of the patient's physician. The primary study end point is incident AF during the screening period. Key secondary outcomes include new oral anticoagulation prescriptions, incident ischemic stroke, and major hemorrhage during a 24-month period following the study start. Outcomes are ascertained based on electronic health record documentation and are manually adjudicated. The results of this pragmatic trial may help identify a model for widespread adoption of AF screening as part of routine clinical practice.",2019,"Key secondary outcomes include new oral anticoagulation prescriptions, incident ischemic stroke, and major hemorrhage during a 24-month period following the study start.","['atrial fibrillation at primary care visits', '16,000 patients in each arm', 'individuals 65 years or older during primary care visits', 'eligible patients who agree to participate during office visits using a single-lead ECG device']",['AF screening'],"['new oral anticoagulation prescriptions, incident ischemic stroke, and major hemorrhage']","[{'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0028900', 'cui_str': 'Office Visits'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}]",,0.0527347,"Key secondary outcomes include new oral anticoagulation prescriptions, incident ischemic stroke, and major hemorrhage during a 24-month period following the study start.","[{'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Ashburner', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA; Department of Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Atlas', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA; Department of Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'McManus', 'Affiliation': 'Department of Medicine, University of Massachusetts Medical School, Worcester, MA.'}, {'ForeName': 'Yuchiao', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA; Department of Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Ana T', 'Initials': 'AT', 'LastName': 'Trisini Lipsanopoulos', 'Affiliation': 'Cardiovascular Research Center and Cardiac Arrhythmia Service, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Leila H', 'Initials': 'LH', 'LastName': 'Borowsky', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Wyliena', 'Initials': 'W', 'LastName': 'Guan', 'Affiliation': 'Cardiovascular Research Center and Cardiac Arrhythmia Service, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Patrick T', 'Initials': 'PT', 'LastName': 'Ellinor', 'Affiliation': 'Cardiovascular Research Center and Cardiac Arrhythmia Service, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Singer', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA; Department of Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Lubitz', 'Affiliation': 'Cardiovascular Research Center and Cardiac Arrhythmia Service, Massachusetts General Hospital, Boston, MA. Electronic address: slubitz@mgh.harvard.edu.'}]",American heart journal,['10.1016/j.ahj.2019.06.011']
1867,32042773,PEEP guided by electrical impedance tomography during one-lung ventilation in elderly patients undergoing thoracoscopic surgery.,"Background


To examine the influence of positive end-expiratory pressure (PEEP) settings on lung mechanics and oxygenation in elderly patients undergoing thoracoscopic surgery.
Methods


One hundred patients aged >65 years were randomly allocated into either the PEEP 5  or the electrical impedance tomography (EIT) group (PEEP EIT ). Each group underwent volume-controlled ventilation (tidal volume 6 mL/kg predicted body weight) with the PEEP either fixed at 5 cmH 2 O or set at an individualized EIT setting. The primary endpoint was the ratio of the arterial oxygen partial pressure to the fractional inspired oxygen (PaO 2 /FiO 2 ). The secondary endpoints included the driving pressure, and dynamic respiratory system compliance (C dyn ). Other outcomes, such as the mean airway pressure (P mean ), mean arterial pressure (MAP), lung complications and the length of hospital stay were explored.
Results


The optimal PEEP set by EIT was significantly higher (range from 9-13 cmH 2 O) than the fixed PEEP. PaO 2 /FiO 2  was 47 mmHg higher (95% CI: 7-86 mmHg; P=0.021), C dyn  was 4.3 mL/cmH 2 O higher (95% CI: 2.1-6.7 cmH 2 O; P<0.001), and the driving pressure was 3.7 cmH 2 O lower (95% CI: 2.2-5.1 mmH 2 O; P<0.001) at 0.5 h during one-lung ventilation (OLV) in the PEEP EIT  group than in the PEEP 5  group. At 1 h during OLV, PaO 2 /FiO 2  was 93 mmHg higher (95% CI: 58-128 mmHg; P<0.001), C dyn  was 4.4 mL/cmH 2 O higher (95% CI: 1.9-6.9 mL/cmH 2 O; P=0.001), and the driving pressure was 4.9 cmH 2 O lower (95% CI: 3.8-6.1 cmH 2 O; P<0.001) in the PEEP EIT  group than in the PEEP 5  group. PaO 2 /FiO 2  was 107 mmHg higher (95% CI: 56-158 mmHg; P<0.001) in the PEEP EIT  group than in the PEEP 5  group during double-lung ventilation at the end of surgery.
Conclusions


PEEP values determined with EIT effectively improved oxygenation and lung mechanics during one lung ventilation in elderly patients undergoing thoracoscopic surgery.",2019,"PaO 2 /FiO 2  was 47 mmHg higher (95% CI: 7-86 mmHg; P=0.021), C dyn  was 4.3 mL/cmH 2","['elderly patients undergoing thoracoscopic surgery', 'One hundred patients aged >65 years']","['positive end-expiratory pressure (PEEP) settings', 'PEEP guided by electrical impedance tomography', 'volume-controlled ventilation (tidal volume 6 mL/kg predicted body weight) with the PEEP either fixed at 5 cmH 2 O or set at an individualized EIT setting', 'PEEP 5  or the electrical impedance tomography (EIT) group (PEEP EIT ']","['driving pressure', 'oxygenation and lung mechanics', 'mean airway pressure (P mean ), mean arterial pressure (MAP), lung complications and the length of hospital stay', 'driving pressure, and dynamic respiratory system compliance (C dyn ', 'ratio of the arterial oxygen partial pressure to the fractional inspired oxygen (PaO 2 /FiO 2 ']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751551', 'cui_str': 'Surgical Procedures, Thoracoscopic'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0807495', 'cui_str': 'Positive end expiratory pressure setting'}, {'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0162537', 'cui_str': 'Electrical Impedance'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C1320708', 'cui_str': 'Volume controlled ventilation'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C3541375', 'cui_str': 'RESPIRATORY SYSTEM'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}]",100.0,0.152047,"PaO 2 /FiO 2  was 47 mmHg higher (95% CI: 7-86 mmHg; P=0.021), C dyn  was 4.3 mL/cmH 2","[{'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, China.'}, {'ForeName': 'Chengya', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, China.'}, {'ForeName': 'Meiying', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, China.'}, {'ForeName': 'Jingxiang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, China.'}, {'ForeName': 'Inez', 'Initials': 'I', 'LastName': 'Frerichs', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Medical Center of Schleswig-Holstein, Campus Kiel, Germany.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Moeller', 'Affiliation': 'Institute of Technical Medicine, Furtwangen University, Villingen-Schwenningen, Germany.'}, {'ForeName': 'Zhanqi', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Institute of Technical Medicine, Furtwangen University, Villingen-Schwenningen, Germany.'}]",Annals of translational medicine,['10.21037/atm.2019.11.95']
1868,32222580,Use of sound-elicited fetal heart rate accelerations to assess fetal hearing in the second and third trimester.,"OBJECTIVES


We previously reported that fetal heart rate (FHR) accelerations could be obtained after fetal sound stimulation. We examined FHR accelerations during 20-37 weeks gestational age (GA) in order to assess the optimal time for the test.
METHODS


The fetus was stimulated from the maternal abdomen with pure tone 2000 Hz, 90 dB, 5 s. Changes in the FHR before and after the sound stimulation were measured by a cardiotocometer.
RESULTS


Compared with the positive rate of FHR accelerations at 20-21 weeks GA, significant increases were recognized in 26-27, 28 to 29, 30 to 31, and 34-35 weeks GA. Comparing the positive rate of FHR accelerations between the minimal and moderate variability of FHR baseline, no significant differences were observed at 20-27 weeks GA. On the other hand, at 28-37 weeks GA, the positive rate to detect FHR accelerations due to sound stimulation was 100% in moderate FHR baseline variability.
CONCLUSION


Considering development of human fetal hearing, the method should be performed between 28 and 37 weeks GA and during moderate FHR variability corresponding to active sleep conditions. The method developed in the present study may provide a promising tool for evaluating the fetal hearing.",2020,"Comparing the positive rate of FHR accelerations between the minimal and moderate variability of FHR baseline, no significant differences were observed at 20-27 weeks GA.",[],['sound-elicited fetal heart rate accelerations'],"['positive rate to detect FHR accelerations', 'positive rate of FHR accelerations', 'fetal heart rate (FHR) accelerations', 'fetal hearing', 'FHR accelerations']",[],"[{'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0018811', 'cui_str': 'Heart Rate, Fetal'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0018811', 'cui_str': 'Heart Rate, Fetal'}]",,0.0568937,"Comparing the positive rate of FHR accelerations between the minimal and moderate variability of FHR baseline, no significant differences were observed at 20-27 weeks GA.","[{'ForeName': 'Remi', 'Initials': 'R', 'LastName': 'Hibiya-Motegi', 'Affiliation': 'Department of Otorhinolaryngology, Juntendo University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Nakayama', 'Affiliation': 'Department of Mechanical Engineering and Intelligent Systems, Graduate School of Informatics and Engineering, The University of Electro-Communications, Tokyo, Japan.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Matsuoka', 'Affiliation': 'Department of Otorhinolaryngology, Juntendo University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takeda', 'Affiliation': 'Department of Obstetrics and Gynecology, Juntendo University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shuko', 'Initials': 'S', 'LastName': 'Nojiri', 'Affiliation': 'Medical Technology Innovation Center Clinical Research, Trial Center Juntendo University, Tokyo, Japan.'}, {'ForeName': 'Atsuo', 'Initials': 'A', 'LastName': 'Itakura', 'Affiliation': 'Department of Obstetrics and Gynecology, Juntendo University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Koike', 'Affiliation': 'Department of Mechanical Engineering and Intelligent Systems, Graduate School of Informatics and Engineering, The University of Electro-Communications, Tokyo, Japan.'}, {'ForeName': 'Katsuhisa', 'Initials': 'K', 'LastName': 'Ikeda', 'Affiliation': 'Department of Otorhinolaryngology, Juntendo University Faculty of Medicine, Tokyo, Japan. Electronic address: ike@juntendo.ac.jp.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110001']
1869,31746629,Role of the carotid chemoreceptors in insulin-mediated sympathoexcitation in humans.,"We examined the contribution of the carotid chemoreceptors to insulin-mediated increases in muscle sympathetic nerve activity (MSNA) in healthy humans. We hypothesized that reductions in carotid chemoreceptor activity would attenuate the sympathoexcitatory response to hyperinsulinemia. Young, healthy adults (9 male/9 female, 28 ± 1 yr, 24 ± 1 kg/m 2 ) completed a 30-min euglycemic baseline followed by a 90-min hyperinsulinemic (1 mU·kg fat-free mass -1 ·min -1 ), euglycemic infusion. MSNA (microneurography of the peroneal nerve) was continuously measured. The role of the carotid chemoreceptors was assessed at baseline and during hyperinsulinemia via  1 ) acute hyperoxia,  2 ) low-dose dopamine (1-4 µg·kg -1 ·min -1 ), and  3 ) acute hyperoxia + low-dose dopamine. MSNA burst frequency increased from baseline during hyperinsulinemia ( P  < 0.01). Acute hyperoxia had no effect on MSNA burst frequency at rest ( P  = 0.74) or during hyperinsulinemia ( P  = 0.83). The insulin-mediated increase in MSNA burst frequency ( P  = 0.02) was unaffected by low-dose dopamine ( P  = 0.60). When combined with low-dose dopamine, acute hyperoxia had no effect on MSNA burst frequency at rest ( P  = 0.17) or during hyperinsulinemia ( P  = 0.85). Carotid chemoreceptor desensitization in young, healthy men and women does not attenuate the sympathoexcitatory response to hyperinsulinemia. Our data suggest that the carotid chemoreceptors do not contribute to acute insulin-mediated increases in MSNA in young, healthy adults.",2020,Acute hyperoxia had no effect on MSNA burst frequency at rest (p=0.74) or during hyperinsulinemia (p=0.83).,"['Young, healthy adults (9M/9F, 28±1 yrs, 24±1 kg/m 2 ) completed a', 'young, healthy men and women', 'humans', 'young, healthy adults', 'healthy humans']","['hyperoxia + low-dose dopamine', '30-min euglycemic baseline followed by a 90-min hyperinsulinemic (1 mU/kg FFM/min), euglycemic infusion']","['MSNA burst frequency', 'muscle sympathetic nerve activity (MSNA', 'carotid chemoreceptors']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0242706', 'cui_str': 'Hyperoxia'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1960958', 'cui_str': 'mU/kg'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure (body structure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,,Acute hyperoxia had no effect on MSNA burst frequency at rest (p=0.74) or during hyperinsulinemia (p=0.83).,"[{'ForeName': 'Jacqueline K', 'Initials': 'JK', 'LastName': 'Limberg', 'Affiliation': 'Department of Anesthesiology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Blair D', 'Initials': 'BD', 'LastName': 'Johnson', 'Affiliation': 'Department of Anesthesiology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Mozer', 'Affiliation': 'Department of Anesthesiology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Walter W', 'Initials': 'WW', 'LastName': 'Holbein', 'Affiliation': 'Department of Anesthesiology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Curry', 'Affiliation': 'Department of Anesthesiology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Nanduri R', 'Initials': 'NR', 'LastName': 'Prabhakar', 'Affiliation': 'Institute for Integrative Physiology, School of Medicine, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Joyner', 'Affiliation': 'Department of Anesthesiology, Mayo Clinic, Rochester, Minnesota.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00257.2019']
1870,31134278,Corrigendum to: Can menstrual health apps selected based on users' needs change health-related factors? A double-blind randomized controlled trial.,,2019,,[],[],[],[],[],[],,0.725061,,[],Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocz083']
1871,31737988,Gradually closing the loop.,"The Lariat device is an epicardial nonimplant suture delivery device capable of left atrial appendage closure. The current study offers promising results but is limited by small sample size and multiple foundational issues with study design. aMaze, a large multi-center prospective randomized trial is currently underway and will provide additional insight into the safety of this device and its efficacy in maintenance of sinus rhythm after atrial fibrillation ablation.",2019,The Lariat device is an epicardial nonimplant suture delivery device capable of left atrial appendage closure.,[],['aMaze'],[],[],"[{'cui': 'C0102901', 'cui_str': 'Amaze'}]",[],,0.0568751,The Lariat device is an epicardial nonimplant suture delivery device capable of left atrial appendage closure.,"[{'ForeName': 'Elliot S', 'Initials': 'ES', 'LastName': 'Jerud', 'Affiliation': 'Department of Cardiology, Lankenau Heart Institute, Wynnewood, Pennsylvania.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Gray', 'Affiliation': 'Interventional Cardiology, Lankenau Heart Institute, Wynnewood, Pennsylvania.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28570']
1872,29067219,Driving with Hemianopia V: Do Individuals with Hemianopia Spontaneously Adapt Their Gaze Scanning to Differing Hazard Detection Demands?,"PURPOSE


We investigated whether people with homonymous hemianopia (HH) were able to spontaneously (without training or instructions) adapt their blind-side scan magnitudes in response to differing scanning requirements for detection of pedestrians in a driving simulator when differing cues about pedestrian eccentricities and movement behaviors were available in the seeing hemifield.
METHODS


Twelve HH participants completed two sessions in a driving simulator pressing the horn when they detected a pedestrian. Stationary pedestrians outside the driving lane were presented in one session and approaching pedestrians on a collision course in the other. Gaze data were analyzed for pedestrians initially appearing at approximately 14° in the blind hemifield. No instructions were given regarding scanning.
RESULTS


After appearing, the stationary pedestrians' eccentricity increased rapidly to a median of 31° after 2.5 seconds, requiring increasingly larger blind-side gaze scans for detection, while the approaching pedestrians' eccentricity remained constant at approximately 14°, requiring a more moderate scan (∼14°) for detection. Although median scan magnitudes did not differ between the two conditions (approaching: 14° [IQR 9°-15°]; stationary: 13° [IQR 9°-20°];  P  = 0.43), three participants showed evidence of adapting (increasing) their blind-side scan magnitudes in the stationary condition.
CONCLUSIONS


Three participants (25%) appeared to be able to apply voluntary cognitive control to modify their blind-side gaze scanning in response to the differing scanning requirements of the two conditions without explicit training.
TRANSLATIONAL RELEVANCE


Our results suggest that only a minority of people with hemianopia are likely to be able to  spontaneously  adapt their blind-side scanning in response to rapidly changing and unpredictable situations in on-road driving.",2017,"Although median scan magnitudes did not differ between the two conditions (approaching: 14° [IQR 9°-15°]; stationary: 13° [IQR 9°-20°];  P  = 0.43), three participants showed evidence of adapting (increasing) their blind-side scan magnitudes in the stationary condition.
","['Twelve HH participants', 'people with homonymous hemianopia (HH']",['Hemianopia V'],"['Gaze data', 'median scan magnitudes']","[{'cui': 'C0271202', 'cui_str': 'Hemianopsia, Homonymous'}]","[{'cui': 'C0018979', 'cui_str': 'Hemianopia'}]","[{'cui': 'C0553544', 'cui_str': 'Gaze (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0441633'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}]",12.0,0.07115,"Although median scan magnitudes did not differ between the two conditions (approaching: 14° [IQR 9°-15°]; stationary: 13° [IQR 9°-20°];  P  = 0.43), three participants showed evidence of adapting (increasing) their blind-side scan magnitudes in the stationary condition.
","[{'ForeName': 'Concetta F', 'Initials': 'CF', 'LastName': 'Alberti', 'Affiliation': 'Department of Psychology, College of Science, Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Goldstein', 'Affiliation': 'Schepens Eye Research Institute, Massachusetts Eye and Ear, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Peli', 'Affiliation': 'Schepens Eye Research Institute, Massachusetts Eye and Ear, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Alex R', 'Initials': 'AR', 'LastName': 'Bowers', 'Affiliation': 'Schepens Eye Research Institute, Massachusetts Eye and Ear, Harvard Medical School, Boston, MA, USA.'}]",Translational vision science & technology,['10.1167/tvst.6.5.11']
1873,30318946,Post-discharge use of assistive devices following hemiarthroplasty: comparison of fracture patients with or without hip precautions.,"Purpose:  To describe which types of assistive devices prescribed and actually used, either due to precautions or due to true functional reasons, after hip fracture-related hemiarthroplasty. Materials and methods:  About 394 patients cluster-randomized 2010-2014 at a university hospital. Control group with standard postoperative precautions to reduce dislocations, mandatory assistive devices and knee brace for 6 weeks (in cognitively impaired) compared to non-precaution group with assistive devices only if needed. Postal questionnaire at 6 weeks and 3 months. Results:  Both prescription and usage of reacher were higher in the precaution group. About 55% of patients with precautions was instructed to use stocking aids, 21% continued to do so. Significantly fewer without precautions, 11%, used it at 3 months. Raised toilet seat was used by ∼40% of all pre-fracture and was prescribed to 79% with precautions. It was unchanged at 42% in non-precaution group. Nevertheless, 64% in non-precaution group used a raised toilet both at 6 weeks and 3 months. The usage persisted around 70% in precaution group. Usage of raised chair/bed were similar, even if non-precaution patients was not prescribed such. In the precaution group, 102 were prescribed a knee brace, only 5 used it at 6 weeks. Conclusions:  The use of assistive devices did not follow what was prescribed from the hospital, regardless of precautions or not. The use of higher furniture was similar regardless of precautions or not. Other devices were more common in the precaution group. The compliance of knee bracing was low, and bracing should not be standard-of-care.Implications for rehabilitationHemiarthroplasty is the most common treatment of displaced femoral neck fracture in elderly. Dislocation occur in 2 to 10% of these patients, and traditionally patients have been instructed to be careful when moving their leg and to use a number of assistive devices, in order to reduce the dislocation risk.The evidence base for such precautions is weak and occupational therapy and assistive devices may be costly. The current study shows that prescriptions and instructions from occupational therapists in hospital is more or less not follow after dismissal.Assistive devices should be prescribed based on the hip fracture patient's true functional needs, and not routinely or due to arthroplasty precautions.",2019,"Nevertheless, 64% in non-precaution group used a raised toilet both at 6 weeks and 3 months.","['fracture patients with or without hip precautions', 'About 394 patients cluster-randomized 2010-2014 at a university hospital', 'displaced femoral neck fracture in elderly']","['assistive devices', 'rehabilitation Hemiarthroplasty', 'hemiarthroplasty']",[],"[{'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0015806', 'cui_str': 'Femur Neck Fractures'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0036605', 'cui_str': 'Assistive Technology'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}]",[],,0.0394824,"Nevertheless, 64% in non-precaution group used a raised toilet both at 6 weeks and 3 months.","[{'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Rogmark', 'Affiliation': 'Department of Orthopedics, Skane University Hospital, Malmö, Sweden.'}, {'ForeName': 'Ammar', 'Initials': 'A', 'LastName': 'Jobory', 'Affiliation': 'Department of Orthopedics, Skane University Hospital, Malmö, Sweden.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Unger', 'Affiliation': 'Department of Orthopedics, Skane University Hospital, Malmö, Sweden.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Nilsson', 'Affiliation': 'Department of Orthopedics, Skane University Hospital, Malmö, Sweden.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Dahlqvist', 'Affiliation': 'Department of Orthopedics, Skane University Hospital, Malmö, Sweden.'}]",Disability and rehabilitation. Assistive technology,['10.1080/17483107.2018.1499141']
1874,31392812,"Modelling the potential prevention benefits of a treat-all hepatitis C treatment strategy at global, regional and country levels: A modelling study.","The World Health Organization (WHO) recently produced guidelines advising a treat-all policy for HCV to encourage widespread treatment scale-up for achieving HCV elimination. We modelled the prevention impact achieved (HCV infections averted [IA]) from initiating this policy compared with treating different subgroups at country, regional and global levels. We assessed what country-level factors affect impact. A dynamic, deterministic HCV transmission model was calibrated to data from global systematic reviews and UN data sets to simulate country-level HCV epidemics with ongoing levels of treatment. For each country, the model projected the prevention impact (in HCV IA per treatment undertaken) of initiating four treatment strategies; either selected randomly (treat-all) or targeted among people who inject drugs (PWID), people aged ≥35, or those with cirrhosis. The IA was assessed over 20 years. Linear regression was used to identify associations between IA per treatment and demographic factors. Eighty-eight countries (85% of the global population) were modelled. Globally, the model estimated 0.35 (95% credibility interval [95%CrI]: 0.16-0.61) IA over 20 years for every randomly allocated treatment, 0.30 (95%CrI: 0.12-0.53) from treating those aged ≥35 and 0.28 (95%CrI: 0.12-0.49) for those with cirrhosis. Globally, treating PWID achieved 1.27 (95%CrI: 0.68-2.04) IA per treatment. The IA per randomly allocated treatment was positively associated with a country's population growth rate and negatively associated with higher HCV prevalence among PWID. In conclusion, appreciable prevention benefits could be achieved from WHO's treat-all strategy, although greater benefits per treatment can be achieved through targeting PWID. Higher impact will be achieved in countries with high population growth.",2019,The IA per randomly allocated treatment was positively associated with a country's population growth rate and negatively associated with higher HCV prevalence among PWID.,"['people who inject drugs (PWID), people aged ≥35, or those with cirrhosis']",[],[],"[{'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}]",[],[],,0.0512625,The IA per randomly allocated treatment was positively associated with a country's population growth rate and negatively associated with higher HCV prevalence among PWID.,"[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Trickey', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Fraser', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Aaron G', 'Initials': 'AG', 'LastName': 'Lim', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Josephine G', 'Initials': 'JG', 'LastName': 'Walker', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Peacock', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Colledge', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Janni', 'Initials': 'J', 'LastName': 'Leung', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Grebely', 'Affiliation': 'Institute for Health Metrics and Evaluation, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Larney', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Natasha K', 'Initials': 'NK', 'LastName': 'Martin', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Degenhardt', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hickman', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Margaret T', 'Initials': 'MT', 'LastName': 'May', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vickerman', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}]",Journal of viral hepatitis,['10.1111/jvh.13187']
1875,31758661,Making Better Dose Decisions: Using Exposure-Response Modeling to Integrate Efficacy Outcome of Two Phase IIb Clinical Trials of Ubrogepant for Migraine Treatment.,"Ubrogepant (MK-1602) is a novel, oral, calcitonin gene-related peptide receptor antagonist in clinical development with positive phase III outcomes for acute treatment of migraine. This paper describes the population exposure-response (E-R) modeling and simulations, which were used to inform the phase III dose-selection rationale, based on ~ 800 participants pooled across two phase IIb randomized dose-finding clinical trials. The E-R model describes the placebo and ubrogepant treatment effects based on migraine pain end points (2-hour pain relief and 2-hour pain freedom) at various dose levels. Sensitivity analyses were conducted to evaluate various assumptions of placebo response in light of the high placebo response observed in one phase II trial. A population pharmacokinetic model describing the effect of formulations was included in the E-R simulation framework to assess potential dose implications of a formulation switch from phase II to phase III. Model-based simulations predict that a dose of 25 mg or higher is likely to achieve significantly better efficacy than placebo with desirable efficacy levels. The understanding of E-R helped support the dose selection for the phase III clinical trials.",2020,"Ubrogepant (MK-1602) is a novel, oral, calcitonin gene-related peptide receptor antagonist in clinical development with positive Phase III outcomes for acute treatment of migraine.",[],"['placebo', 'Ubrogepant (MK-1602']",['migraine pain endpoints (2-hour pain relief and 2-hour pain freedom'],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4505936', 'cui_str': 'ubrogepant'}, {'cui': 'C4505937', 'cui_str': 'MK-1602'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}]",800.0,0.0400702,"Ubrogepant (MK-1602) is a novel, oral, calcitonin gene-related peptide receptor antagonist in clinical development with positive Phase III outcomes for acute treatment of migraine.","[{'ForeName': 'Chi-Chung', 'Initials': 'CC', 'LastName': 'Li', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Tiffini', 'Initials': 'T', 'LastName': 'Voss', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kowalski', 'Affiliation': 'Ann Arbor Pharmacometrics Group (A2PG), Ann Arbor, Michigan, USA.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Ann Arbor Pharmacometrics Group (A2PG), Ann Arbor, Michigan, USA.'}, {'ForeName': 'Huub Jan', 'Initials': 'HJ', 'LastName': 'Kleijn', 'Affiliation': 'Certara Strategic Consulting, Oss, The Netherlands.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Jones', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Rolien', 'Initials': 'R', 'LastName': 'Bosch', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Michelson', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'DeAngelis', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Xie', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Prajakti A', 'Initials': 'PA', 'LastName': 'Kothare', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}]",Clinical and translational science,['10.1111/cts.12730']
1876,31404538,A mixed-methods study of provider perspectives on My Birth Control: a contraceptive decision support tool designed to facilitate shared decision making.,"OBJECTIVES


Barriers to the provision of patient-centered contraceptive counseling include time limitations, frequent misconceptions and misinformation about methods among patients, and the availability of numerous contraceptive options, which increases the complexity of contraceptive decision making. Decision support tools are interventions designed to facilitate quality decision making in preference-sensitive decisions. We evaluated the impact of a contraceptive decision support tool, My Birth Control, on providers' experience with contraceptive counseling.
STUDY DESIGN


We interviewed 15 providers who participated in the intervention arm of a cluster randomized controlled trial of My Birth Control to obtain their impressions of their patients' interactions with the tool. We analyzed the interviews using thematic analysis, compared appointment lengths of patients in each arm (n=749) and assessed provider burnout in each arm (n=28).
RESULTS


Providers reported that incorporating My Birth Control into their practice helped them allocate time more efficiently, enabling them to hone in on patients' areas of interest. They also reported that patients who interacted with the tool appeared more informed about contraception options and features, and took a more active role in method selection. All providers described using the tool as acceptable and feasible, and indicated they would like to incorporate it into their practice. There was no difference in provider burnout scores comparing before and after the trial of My Birth Control.
CONCLUSION


Providers had a positive impression of the impact of My Birth Control on contraceptive counseling, including the quality of counseling, and perceived the tool to be a feasible intervention to use in the clinical setting.
IMPLICATIONS


Family planning clinics should consider incorporating My Birth Control into their clinical services as a means of improving contraceptive care and provider experience of counseling.",2019,"There was no difference in provider burnout scores comparing before and after the trial of My Birth Control.
","['patients in each arm (n=749) and assessed provider burnout in each arm (n=28', 'fifteen providers who participated in the intervention arm of a cluster-randomized trial of']",['My Birth Control'],['provider burnout scores'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}]","[{'cui': 'C0700589', 'cui_str': 'Fertility Control'}]","[{'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",749.0,0.032082,"There was no difference in provider burnout scores comparing before and after the trial of My Birth Control.
","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Dehlendorf', 'Affiliation': 'Department of Family & Community Medicine, University of California, San Francisco; Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco; Department of Epidemiology & Biostatistics, University of California, San Francisco. Electronic address: christine.dehlendorf@ucsf.edu.'}, {'ForeName': 'Reiley', 'Initials': 'R', 'LastName': 'Reed', 'Affiliation': 'Department of Family & Community Medicine, University of California, San Francisco.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Fitzpatrick', 'Affiliation': 'Department of Family & Community Medicine, University of California, San Francisco.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Kuppermann', 'Affiliation': 'Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco; Department of Epidemiology & Biostatistics, University of California, San Francisco.'}, {'ForeName': 'Jody', 'Initials': 'J', 'LastName': 'Steinauer', 'Affiliation': 'Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Kimport', 'Affiliation': 'Advancing New Standards in Reproductive Health (ANSIRH), University of California San Francisco.'}]",Contraception,['10.1016/j.contraception.2019.08.001']
1877,31568338,"A Prospective, Randomized, Blinded Trial Comparing Digital Simulation to Textbook for Cleft Surgery Education.",,2019,,[],[],[],[],[],[],,0.086774,,"[{'ForeName': 'Malke', 'Initials': 'M', 'LastName': 'Asaad', 'Affiliation': 'Division of Plastic Surgery Department of Surgery Division of Plastic Surgery, Mayo Clinic, Rochester, Minn.'}, {'ForeName': 'Aashish', 'Initials': 'A', 'LastName': 'Rajesh', 'Affiliation': ''}, {'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Vyas', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006053']
1878,31708457,"Letter to the Editor on ""Treatment of lateral ankle sprain with platelet-rich plasma: A randomized clinical study"".",,2019,,[],['platelet-rich plasma'],[],[],"[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}]",[],,0.0230868,,"[{'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Dahmen', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Orthopaedic Surgery, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, The Netherlands; Academic Center for Evidence Based Sports medicine (ACES), The Netherlands; Amsterdam Collaboration for Health and Safety in Sports (ACHSS), International Olympic Committee (IOC) Research Center Amsterdam UMC, The Netherlands.'}, {'ForeName': 'Liam D A', 'Initials': 'LDA', 'LastName': 'Paget', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Orthopaedic Surgery, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, The Netherlands; Academic Center for Evidence Based Sports medicine (ACES), The Netherlands; Amsterdam Collaboration for Health and Safety in Sports (ACHSS), International Olympic Committee (IOC) Research Center Amsterdam UMC, The Netherlands.'}, {'ForeName': 'Gustaaf', 'Initials': 'G', 'LastName': 'Reurink', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Orthopaedic Surgery, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, The Netherlands; Academic Center for Evidence Based Sports medicine (ACES), The Netherlands; Amsterdam Collaboration for Health and Safety in Sports (ACHSS), International Olympic Committee (IOC) Research Center Amsterdam UMC, The Netherlands.'}, {'ForeName': 'Johannes L', 'Initials': 'JL', 'LastName': 'Tol', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Orthopaedic Surgery, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, The Netherlands; Academic Center for Evidence Based Sports medicine (ACES), The Netherlands; Amsterdam Collaboration for Health and Safety in Sports (ACHSS), International Olympic Committee (IOC) Research Center Amsterdam UMC, The Netherlands; Aspetar, Orthopaedic and Sports Medicine Hospital, Doha, Qatar.'}, {'ForeName': 'Gino M M J', 'Initials': 'GMMJ', 'LastName': 'Kerkhoffs', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Orthopaedic Surgery, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, The Netherlands; Academic Center for Evidence Based Sports medicine (ACES), The Netherlands; Amsterdam Collaboration for Health and Safety in Sports (ACHSS), International Olympic Committee (IOC) Research Center Amsterdam UMC, The Netherlands. Electronic address: g.m.kerkhoffs@amsterdamumc.nl.'}]",Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons,['10.1016/j.fas.2019.10.008']
1879,30988478,A values-alignment intervention protects adolescents from the effects of food marketing.,"Adolescents are exposed to extensive marketing for junk food, which drives overconsumption by creating positive emotional associations with junk food 1-6 . Here we counter this influence with an intervention that frames manipulative food marketing as incompatible with important adolescent values, including social justice and autonomy from adult control. In a preregistered, longitudinal, randomized, controlled field experiment, we show that this framing intervention reduces boys' and girls' implicit positive associations with junk food marketing and substantially improves boys' daily dietary choices in the school cafeteria. Both of these effects were sustained for at least three months. These findings suggest that reframing unhealthy dietary choices as incompatible with important values could be a low-cost, scalable solution to producing lasting, internalized change in adolescents' dietary attitudes and choices.",2019,Both of these effects were sustained for at least three months.,[],[],[],[],[],[],,0.0598307,Both of these effects were sustained for at least three months.,"[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Bryan', 'Affiliation': 'University of Chicago Booth School of Business, Chicago, IL, USA. christopher.bryan@chicagobooth.edu.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Yeager', 'Affiliation': 'University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Cintia P', 'Initials': 'CP', 'LastName': 'Hinojosa', 'Affiliation': 'University of Chicago Booth School of Business, Chicago, IL, USA.'}]",Nature human behaviour,['10.1038/s41562-019-0586-6']
1880,30922106,Effectiveness of psychological intervention as add-on to standard cardiac rehabilitation: Time to adopt new methods or keep doing more of the same?,,2019,,[],['psychological intervention'],[],[],"[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]",[],,0.017222,,"[{'ForeName': 'Susanne S', 'Initials': 'SS', 'LastName': 'Pedersen', 'Affiliation': '1 Department of Psychology, University of Southern Denmark, Denmark.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Doyle', 'Affiliation': '3 Department of Health Psychology, Royal College of Surgeons in Ireland, Ireland.'}]",European journal of preventive cardiology,['10.1177/2047487319840176']
1881,31116468,Issues in the determination of 'responders' and 'non-responders' in physiological research.,"NEW FINDINGS


What is the topic for this review? We discuss the dichotomization of continuous-level physiological measurements into 'responders' and 'non-responders' when interventions/treatments are examined in robust parallel-group studies. What advances does it highlight? Sample responder counts are biased by pre-to-post within-subject variability. Sample differences in counts may be explained wholly by differences in mean response, even without individual response heterogeneity and even if test-retest measurement error informs the choice of response threshold. A less biased and more informative approach uses the SD of individual responses to estimate the chance a new person from the population of interest will be a responder.
ABSTRACT


As a follow-up to our 2015 review, we cover more issues on the topic of 'response heterogeneity', which we define as clinically important individual differences in the physiological responses to the same treatment/intervention that cannot be attributed to random within-subject variability. We highlight various pitfalls with the common practice of counting the number of 'responders', 'non-responders' and 'adverse responders' in samples that have been given certain treatments or interventions for research purposes. We focus on the classical parallel-group randomized controlled trial and assume typical good practice in trial design. We show that sample responder counts are biased because individuals differ in terms of pre-to-post within-subject random variability in the study outcome(s) and not necessarily treatment response. Ironically, sample differences in responder counts may be explained wholly by sample differences in mean response, even if there is no response heterogeneity at all. Sample comparisons of responder counts also have relatively low statistical precision. These problems do not depend on how the response threshold has been selected, e.g. on the basis of a measurement error statistic, and are not rectified fully by the use of confidence intervals for individual responses in the sample. The dichotomization of individual responses in a research sample is fraught with pitfalls. Less biased approaches for estimating the proportion of responders in a population of interest are now available. Importantly, these approaches are based on the SD for true individual responses, directly incorporating information from the control group.",2019,"A less biased and more informative approach uses the SD of individual responses to estimate the chance a new person from the population of interest will be a responder.
",[],[],[],[],[],[],,0.0546727,"A less biased and more informative approach uses the SD of individual responses to estimate the chance a new person from the population of interest will be a responder.
","[{'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Atkinson', 'Affiliation': 'School of Health and Social Care, Teesside University, Middlesbrough, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Williamson', 'Affiliation': 'Faculty of Health Sciences, School of Life Sciences, University of Hull, Hull, UK.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Batterham', 'Affiliation': 'School of Health and Social Care, Teesside University, Middlesbrough, UK.'}]",Experimental physiology,['10.1113/EP087712']
1882,31280725,Invited commentary in response to: Vitamin D 3  supplementation for 8 weeks leads to improved haematological status following the consumption of an iron-fortified breakfast cereal: a double-blind randomised controlled trial in iron-deficient women.,,2019,,['iron-deficient women'],['Vitamin D3 supplementation'],['haematological status'],"[{'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C3265062', 'cui_str': 'vitamin D3'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",,0.508424,,"[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Blanco-Rojo', 'Affiliation': 'Research Department, Biosearch Life, Granada, Spain.'}]",The British journal of nutrition,['10.1017/S0007114519001569']
1883,31553474,How and when informative visit processes can bias inference when using electronic health records data for clinical research.,"OBJECTIVE


Electronic health records (EHR) data have become a central data source for clinical research. One concern for using EHR data is that the process through which individuals engage with the health system, and find themselves within EHR data, can be informative. We have termed this process informed presence. In this study we use simulation and real data to assess how the informed presence can impact inference.
MATERIALS AND METHODS


We first simulated a visit process where a series of biomarkers were observed informatively and uninformatively over time. We further compared inference derived from a randomized control trial (ie, uninformative visits) and EHR data (ie, potentially informative visits).
RESULTS


We find that only when there is both a strong association between the biomarker and the outcome as well as the biomarker and the visit process is there bias. Moreover, once there are some uninformative visits this bias is mitigated. In the data example we find, that when the ""true"" associations are null, there is no observed bias.
DISCUSSION


These results suggest that an informative visit process can exaggerate an association but cannot induce one. Furthermore, careful study design can, mitigate the potential bias when some noninformative visits are included.
CONCLUSIONS


While there are legitimate concerns regarding biases that ""messy"" EHR data may induce, the conditions for such biases are extreme and can be accounted for.",2019,"We further compared inference derived from a randomized control trial (ie, uninformative visits) and EHR data (ie, potentially informative visits).
",[],[],[],[],[],[],,0.0404811,"We further compared inference derived from a randomized control trial (ie, uninformative visits) and EHR data (ie, potentially informative visits).
","[{'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Goldstein', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Phelan', 'Affiliation': 'Center for Predictive Medicine, Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Neha J', 'Initials': 'NJ', 'LastName': 'Pagidipati', 'Affiliation': 'Center for Predictive Medicine, Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Peskoe', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocz148']
1884,30814028,Growth in HIV-1-exposed but uninfected infants treated with lopinavir-ritonavir versus lamivudine: a secondary analysis of the ANRS 12174 trial.,"BACKGROUND


The tolerance of antiretroviral drugs in infants must be carefully evaluated. In previous studies of children with HIV type 1 (HIV-1) less weight gain was observed in children given lopinavir-ritonavir-based combinations than those given nevirapine. We aimed to compare the effects of lopinavir-ritonavir and lamivudine on growth in HIV-exposed uninfected infants included in the ANRS 12174 trial.
METHODS


ANRS 12174 was a multicentre, randomised, controlled trial of infant prophylaxis to prevent HIV-1 transmission by breastfeeding done at four antenatal clinics in Burkina Faso, South Africa, Uganda, and Zambia. HIV-exposed uninfected infants born to asymptomatic mothers not eligible for antiretroviral therapy (CD4 count >350 cells per μL) were randomly assigned (1:1) to receive lopinavir-ritonavir or lamivudine 7 days after birth, with stratification by country. In a prespecified secondary analysis, we assessed the effect of lopinavir-ritonavir and lamivudine on the growth of these infants from day 7 until cessation of breastfeeding (maximum treatment time 12 months) in the modified intention-to-treat population, which included all children correctly enrolled with at least one follow-up anthropometric measurement. We compared the growth of infants, defined as children's WHO-defined length-for-age Z score (LAZ), weight-for-length Z score (WAZ), and weight-for-age Z score (WLZ). We used linear mixed effect and β spline-regression models to compare growth between the treatment groups. The trial is registered with ClinicalTrials.gov, number NCT00640263.
FINDINGS


1273 HIV-exposed uninfected infants and their mothers were enrolled between Nov 16, 2009, and May 7, 2013, of whom 1266 (99%) infants were included in the modified intention-to-treat analysis (630 assigned to lopinavir-ritonavir, 636 assigned to lamivudine). Baseline characteristics of the infants and mothers were similar across the two treatment groups. No differences in least-squares (LS) mean LAZ were identified between the treatment groups at any timepoint. LS mean WLZ was significantly lower in the lopinavir-ritonavir group than the lamivudine group at 26 weeks (difference -0·22 [95% CI -0·34 to -0·09], p=0·0006) and 50 weeks (-0·25 [-0·47 to -0·04], p=0·02). LS mean WAZ was also significantly lower in the lopinavir-ritonavir group than the lamivudine group at 26 weeks (difference -0·18 [95% CI -0·30 to -0·05], p=0·01) and 50 weeks (-0·24 [-0·45 to -0·05], p=0·02). Linear mixed models showed that lopinavir-ritonavir was associated with decreases in WLZ and WAZ over time (p<0·0001 and p=0·002), whereas spline regression models indicated that these reductions occurred early and remained constant thereafter (p<0·0001 with a knot at 44 days for WLZ; p=0·02 with a knot at 118 days for WAZ). The difference in LS mean WLZ at 50 weeks between the treatment groups was higher among girls than boys (difference -0·29 [95% CI -0·58 to 0·01], p=0·05 for girls; -0·22 [-0·53 to 0·09], p=0·18 for boys).
INTERPRETATION


Less weight gain was observed in infants given lopinavir-ritonavir than those given lamivudine, which is indicative of a persistent effect that could have long-term deleterious effects. This finding merits attention considering the recommendations for early and lifelong treatment of infants with HIV.
FUNDING


French National Agency for Research on AIDS and Viral Hepatitis, the Total Foundation, the European Developing Countries Clinical Trials Partnership, and the Research Council of Norway.",2019,"INTERPRETATION


Less weight gain was observed in infants given lopinavir-ritonavir than those given lamivudine, which is indicative of a persistent effect that could have long-term deleterious effects.","['infants from day 7 until cessation of breastfeeding (maximum treatment time 12 months) in the modified intention-to-treat population, which included all children correctly enrolled with at least one follow-up anthropometric measurement', '0·24', 'HIV-exposed uninfected infants included in the ANRS 12174 trial', 'HIV-exposed uninfected infants born to asymptomatic mothers not eligible for antiretroviral therapy (CD4 count >350 cells per μL', 'infants with HIV', 'ANRS 12174 was a multicentre, randomised, controlled trial of infant prophylaxis to prevent HIV-1 transmission by breastfeeding done at four antenatal clinics in Burkina Faso, South Africa, Uganda, and Zambia', 'p=0·05 for girls; -0·22 [-0·53 to 0·09], p=0·18 for boys', ""infants, defined as children's WHO-defined length-for-age Z score (LAZ), weight-for-length Z score (WAZ), and weight-for-age Z score (WLZ"", '1273 HIV-exposed uninfected infants and their mothers were enrolled between Nov 16, 2009, and May 7, 2013, of whom 1266 (99%) infants were included in the modified intention-to-treat analysis (630 assigned to']","['0·25', 'lamivudine', 'lopinavir-ritonavir and lamivudine', 'lopinavir-ritonavir', '0·18', 'nevirapine', 'lopinavir-ritonavir or lamivudine', 'lopinavir-ritonavir, 636 assigned to lamivudine']","['WLZ and WAZ', 'least-squares (LS) mean LAZ', 'weight gain', 'LS mean WLZ', 'LS mean WAZ']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C4708165', 'cui_str': 'Six hundred and thirty'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",,0.397927,"INTERPRETATION


Less weight gain was observed in infants given lopinavir-ritonavir than those given lamivudine, which is indicative of a persistent effect that could have long-term deleterious effects.","[{'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Blanche', 'Affiliation': 'Pediatric Immunology-Hematology and Rheumatology Unit, Hôpital Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris, Paris, France. Electronic address: stephane.blanche@aphp.fr.'}, {'ForeName': 'Thorkild', 'Initials': 'T', 'LastName': 'Tylleskär', 'Affiliation': 'Center for International Health, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Peries', 'Affiliation': 'Pathogenesis and Control of Chronic Infections, INSERM U1058, Université de Montpellier, Etablissement Français du Sang, Montpellier, France.'}, {'ForeName': 'Chipepo', 'Initials': 'C', 'LastName': 'Kankasa', 'Affiliation': 'Department of Pediatrics and Child Health, University Teaching Hospital, University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'Ingunn', 'Initials': 'I', 'LastName': 'Engebretsen', 'Affiliation': 'Center for International Health, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Meda', 'Affiliation': 'Center of International Research for Health, Faculty of Health Sciences, University of Ouagadougou, Ouagadougou, Burkina Faso.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Tumwine', 'Affiliation': 'Department of Pediatrics and Child Health, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Mandisa', 'Initials': 'M', 'LastName': 'Singata-Madliki', 'Affiliation': 'Effective Care Research Unit, Cecilia Makiwane Hospital, University of Fort Hare, East London, South Africa.'}, {'ForeName': 'Mwiya', 'Initials': 'M', 'LastName': 'Mwiya', 'Affiliation': 'Department of Pediatrics and Child Health, University Teaching Hospital, University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Van de Perre', 'Affiliation': 'Pathogenesis and Control of Chronic Infections, INSERM U1058, Université de Montpellier, Etablissement Français du Sang, Montpellier, France; Centre Hospitalo-Universitaire de Montpellier, Montpellier, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Nagot', 'Affiliation': 'Pathogenesis and Control of Chronic Infections, INSERM U1058, Université de Montpellier, Etablissement Français du Sang, Montpellier, France; Centre Hospitalo-Universitaire de Montpellier, Montpellier, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(18)30361-8']
1885,31994178,Five-year survival follow-up of a phase III randomised trial comparing ofatumumab versus physicians' choice for bulky fludarabine-refractory chronic lymphocytic leukaemia: a short report.,"In 2014, an interim analysis of a phase 3 study was performed to evaluate the effectiveness of ofatumumab in patients with bulky fludarabine-refractory chronic lymphocytic leukaemia (BFR CLL) as compared to physician's choice. The five-year follow-up of this phase 3 trial showed that ofatumumab therapy resulted in a numerically but not significantly longer overall survival. As only few patients had the chance to receive a kinase inhibitor later, the study displays the survival of BFR CLL patients in the period prior to receiving small-molecule inhibitors. Ofatumumab is a well-tolerable treatment option in multiresistant advanced CLL.",2020,The five-year follow-up of this phase 3 trial showed that ofatumumab therapy resulted in a numerically but not significantly longer overall survival.,"['refractory chronic lymphocytic leukaemia', 'patients with bulky fludarabine-refractory chronic lymphocytic leukaemia (BFR CLL']",['fludarabine'],['overall survival'],"[{'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}]","[{'cui': 'C0059985', 'cui_str': 'fludarabine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0745172,The five-year follow-up of this phase 3 trial showed that ofatumumab therapy resulted in a numerically but not significantly longer overall survival.,"[{'ForeName': 'Udvardy', 'Initials': 'U', 'LastName': 'Miklos', 'Affiliation': 'Department of Hematology, Debrecen University, Debrecen, Hungary.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Strugov', 'Affiliation': 'Almazov National Medical Research Centre, St. Petersburg, Russian Federation.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Lewerin', 'Affiliation': 'Section of Hematology and Coagulation, Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Grosicki', 'Affiliation': 'Department of Hematology and Cancer Prevention, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Mazur', 'Affiliation': 'Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Steurer', 'Affiliation': 'Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Montillo', 'Affiliation': 'Department of Onco-Hematology, Division of Hematology, Niguarda Cancer Center, Niguarda Hospital, Milan, Italy.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Kryachok', 'Affiliation': 'Oncohematology, National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'Middeke', 'Affiliation': 'Medizinische Klinik I, Universitaetsklinikum C.G.Carus, Dresden, Germany.'}, {'ForeName': 'Grygoriy', 'Initials': 'G', 'LastName': 'Rekhtman', 'Affiliation': 'Khmelnytskyi Regional Hospital, Khmelnytskyi, Ukraine.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Stefanelli', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Ghislaine', 'Initials': 'G', 'LastName': 'Vincent', 'Affiliation': 'Novartis Pharma S.A.S, Paris, France.'}, {'ForeName': 'Sameera', 'Initials': 'S', 'LastName': 'Govindaraju', 'Affiliation': 'Novartis Healthcare Pvt. Ltd., Hyderabad, India.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Österborg', 'Affiliation': 'Department of Hematology, Karolinska University Hospital, Stockholm, Sweden.'}]",British journal of haematology,['10.1111/bjh.16429']
1886,31889507,Prevalence of Group A  Streptococcus  in Primary Care Patients and the Utility of C-Reactive Protein and Clinical Scores for Its Identification in Thailand.,"Pharyngitis is usually caused by a viral infection for which antibiotics are often unnecessarily prescribed, adding to the burden of antimicrobial resistance. Identifying who needs antibiotics is challenging; microbiological confirmation and clinical scores are used but have limitations. In a cross-sectional study nested within a randomized controlled trial, we estimated the prevalence and antibiotic susceptibility profiles of group A  Streptococcus  (GAS) in patients presenting to primary care with a sore throat and fever in northern Thailand. We then evaluated the use of C-reactive protein (CRP) and clinical scores (Centor and FeverPAIN) to identify the presence of GAS. One hundred sixty-nine patients were enrolled, of whom 35 (20.7%) had β-hemolytic  Streptococci  (BHS) isolated from throat swab culture, and 11 (6.5%) had GAS. All GAS isolates were sensitive to penicillin G. The median CRP of those without BHS isolation was 10 mg/L (interquartile range [IQR] ≤ 8-18), compared with 18 mg/L (IQR 9-71,  P  = 0.0302) for those with GAS and 14 mg/L (IQR ≤ 8-38,  P  = 0.0516) for those with any BHS isolated. However, there were no significant relationships between CRP > 8 mg/L ( P  = 0.112), Centor ≥ 3 ( P  = 0.212), and FeverPAIN ≥ 4 ( P  = 1.000), and the diagnosis of GAS compared with no BHS isolation. Identifying who requires antibiotics for pharyngitis remains challenging and necessitates further larger studies. C-reactive protein testing alone, although imperfect, can reduce prescribing compared with routine care. Targeted CRP testing through clinical scoring may be the most cost-effective approach to ruling out GAS infection.",2020,"However, there were no significant relationships between CRP > 8 mg/L ( P  = 0.112), Centor ≥ 3 (","['Primary Care Patients with a Sore Throat and Fever in Thailand and the Utility of C-Reactive Protein and Clinical Scores for Its Identification', 'patients presenting to primary care with a sore throat and fever in Northern Thailand', 'One hundred sixty-nine patients were enrolled, of whom 35 (20.7%) had β-hemolytic  Streptococci  (BHS) isolated from throat swab culture, and 11 (6.5%) had GAS']","['penicillin G', 'antibiotic susceptibility profiles of group A  Streptococcus  (GAS']","['C-reactive protein (CRP) and clinical scores (Centor and FeverPAIN', 'median CRP']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0312853', 'cui_str': 'Hemolytic (qualifier value)'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0439056', 'cui_str': 'Throat swab (specimen)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0596601', 'cui_str': 'Gas'}]","[{'cui': 'C0030827', 'cui_str': 'benzylpenicillin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0038411', 'cui_str': 'Streptococcus pyogenes'}, {'cui': 'C0596601', 'cui_str': 'Gas'}]","[{'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",169.0,,"However, there were no significant relationships between CRP > 8 mg/L ( P  = 0.112), Centor ≥ 3 (","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Greer', 'Affiliation': 'Nuffield Department of Medicine, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Althaus', 'Affiliation': 'Nuffield Department of Medicine, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Ling', 'Affiliation': 'Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.'}, {'ForeName': 'Daranee', 'Initials': 'D', 'LastName': 'Intralawan', 'Affiliation': 'Social and Preventive Medicine Department, Chiang Rai Regional Hospital, Chiang Rai, Thailand.'}, {'ForeName': 'Supalert', 'Initials': 'S', 'LastName': 'Nedsuwan', 'Affiliation': 'Social and Preventive Medicine Department, Chiang Rai Regional Hospital, Chiang Rai, Thailand.'}, {'ForeName': 'Janjira', 'Initials': 'J', 'LastName': 'Thaipadungpanit', 'Affiliation': 'Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Tri', 'Initials': 'T', 'LastName': 'Wangrangsimakul', 'Affiliation': 'Nuffield Department of Medicine, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Butler', 'Affiliation': 'Clinical Trials Unit, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Day', 'Affiliation': 'Nuffield Department of Medicine, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Yoel', 'Initials': 'Y', 'LastName': 'Lubell', 'Affiliation': 'Nuffield Department of Medicine, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, United Kingdom.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0502']
1887,31848625,"Commentary: Antibiotic or Silver Versus Standard Ventriculoperitoneal Shunts (BASICS): A Multicentre, Single-Blinded, Randomised Trial and Economic Evaluation.",,2020,,[],['Antibiotic or Silver Versus Standard Ventriculoperitoneal Shunts (BASICS'],[],[],"[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0037125', 'cui_str': 'Silver'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0175662', 'cui_str': 'Ventriculoperitoneal shunt device (physical object)'}]",[],,0.248317,,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Klimo', 'Affiliation': 'Department of Neurosurgery, The University of Tennessee Health Science Center, Memphis, Tennessee.'}, {'ForeName': 'Nickalus R', 'Initials': 'NR', 'LastName': 'Khan', 'Affiliation': 'Department of Neurosurgery, The University of Tennessee Health Science Center, Memphis, Tennessee.'}, {'ForeName': 'Luke G F', 'Initials': 'LGF', 'LastName': 'Smith', 'Affiliation': 'Department of Neurosurgery, The Ohio State University, Columbus, Ohio.'}]",Neurosurgery,['10.1093/neuros/nyz541']
1888,32126551,Frequency and Clinical Impact of Serious Adverse Events on Post-Stroke Recovery with NeuroAiD (MLC601) versus Placebo: The CHInese Medicine Neuroaid Efficacy on Stroke Recovery Study.,"BACKGROUND


Most comparative clinical trials are designed to assess the treatment effect for efficacy endpoints, with less emphasis on the analysis of safety outcomes. However, an extensive analysis of safety data could demonstrate beneficial results in terms of effectiveness by reducing serious adverse events (SAEs), and their unfavourable clinical impact on the study population. We aimed to conduct an exploratory analysis of the CHInese Medicine Neuroaid Efficacy on Stroke recovery (CHIMES) study safety database comparing the frequency of SAEs and their clinical impacts among subjects having received MLC601 or placebo during the first 3 months post-stroke.
METHODS


Analyses were performed by using the safety database of the multicentre, randomised, double-blind, placebo-controlled CHIMES study of 3 months of NeuroAiD versus placebo in subjects with acute ischaemic stroke of intermediate severity in the preceding 72 h. SAEs as reported by investigators at any time-point during the 3-month study were analysed on their frequency and that of any of their outcomes (death, and life threatening, new and/or prolonged hospitalisation, disability, and medical importance, in surviving subjects), as well as their time to onset and resolution.
RESULTS


Of the 1,099 subjects in the CHIMES study, 1,087 were included in the safety analysis (MLC601 = 542) and (placebo = 545); the 12 who did not receive study treatment were excluded. There was a total of 135 subjects with SAEs (MLC601 = 60, placebo = 75). At baseline, overall, subjects with SAEs were older and had lower MMSE score. In the MLC601 group, they had higher NIHSS score, and more frequently a history of ischaemic heart disease and hyperlipidaemia. The number of SAEs per subjects was statistically significantly lower in the MLC601 group than placebo one, especially for subjects with ≥2 SAEs (6.7 vs. 29.3%; p < 0.001). This benefit was seen throughout the study period and during the initial hospitalisation. The main clinical impact of SAEs was an increase in hospitalisation time, reduced in the MLC601 arm with the rate of subjects hospitalised for a prolonged period being significantly threefold lower in surviving subjects (1.1 vs. 3.7%; p < 0.01).
CONCLUSIONS


This post hoc analysis of SAEs from the CHIMES study database shows that subjects receiving a 3-month course of MLC601 experienced fewer SAEs, with lower rates of harmful clinical impacts, especially in terms of hospitalisation duration. These findings could translate to a benefit in terms of reduction of both healthcare burden and additional medical costs.",2020,"The main clinical impact of SAEs was an increase in hospitalisation time, reduced in the MLC601 arm with the rate of subjects hospitalised for a prolonged period being significantly threefold lower in surviving subjects (1.1 vs. 3.7%; p < 0.01).
","[' 1,087 were included in the safety analysis (MLC601 = 542) and (placebo = 545); the 12 who did not receive study treatment were excluded', 'subjects having received', '135 subjects with SAEs (MLC601 = 60, placebo = 75', 'subjects with acute ischaemic stroke of intermediate severity in the preceding 72 h. SAEs as reported by investigators at any time-point during the 3-month study', 'during the first 3\xa0months post-stroke', '1,099 subjects in the CHIMES study']","['MLC601 or placebo', 'placebo', 'NeuroAiD (MLC601', 'NeuroAiD versus placebo', 'MLC601', 'Placebo']","['MMSE score', 'NIHSS score', 'hospitalisation time', 'outcomes (death, and life threatening, new and/or prolonged hospitalisation, disability, and medical importance, in surviving subjects', 'ischaemic heart disease and hyperlipidaemia', 'number of SAEs']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517809', 'cui_str': 'Five hundred and forty-five'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2745174', 'cui_str': 'MLC 601'}]","[{'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",135.0,0.177987,"The main clinical impact of SAEs was an increase in hospitalisation time, reduced in the MLC601 arm with the rate of subjects hospitalised for a prolonged period being significantly threefold lower in surviving subjects (1.1 vs. 3.7%; p < 0.01).
","[{'ForeName': 'Narayanaswamy', 'Initials': 'N', 'LastName': 'Venketasubramanian', 'Affiliation': 'Raffles Neuroscience Centre, Raffles Hospital, Singapore, Singapore, drnvramani@gmail.com.'}, {'ForeName': 'Rajesh B', 'Initials': 'RB', 'LastName': 'Moorakonda', 'Affiliation': 'Singapore Clinical Research Institute, Singapore, Singapore.'}, {'ForeName': 'Qingshu', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Singapore Clinical Research Institute, Singapore, Singapore.'}, {'ForeName': 'Christopher L H', 'Initials': 'CLH', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacology, National University of Singapore, Clinical Research Centre, Singapore, Singapore.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Cerebrovascular diseases (Basel, Switzerland)",['10.1159/000506070']
1889,31984781,"To attend, or not to attend: Examining caregiver intentions and study compliance in a pediatric, randomized controlled trial.","BACKGROUND/AIMS


The  Intent to Attend  is a brief questionnaire recommended by the National Research Council to address dropout concerns and improve prediction of missing data in clinical trials, although implementation has been very limited. As a formative study in pediatric research, the relationship between caregiver intentions and study compliance was investigated in a 180-day trial of dietary supplementation of preterm toddlers. Treatment effect estimation in the context of missing data was also explored.
METHODS


Study compliance (i.e. study completion, supplement adherence, and diary completion) was tracked over three study visits. Baseline questionnaires asked caregivers about intentions concerning study completion via the  Intent to Attend , screened for mental health symptoms (depression, trait anxiety), and captured family demographics. Simple and multiple logistic regression models were built to examine associations between caregiver intent and compliance outcomes. The  Intent to Attend  was also employed as an auxiliary variable to account for missing data within mixed models estimating the treatment effect on the primary outcomes.
RESULTS


Of the 316 caregiver-child dyads included, 95% of caregivers with low intentions had a child complete the study, but only 87% of caregivers with high intentions had a child complete the study. Low intentions to complete the study were associated with a more than 60% lower odds of study non-completion, but the confidence interval included the null (odds ratio: 0.36; 95% confidence interval: 0.11, 1.20). No effect measure modification by caregiver mental health, child sex, or annual income was detected. Income was the only significant predictor of study non-completion; the lowest income group was almost four times more likely to be study non-completers compared with the highest income group, even after adjustment for child sex and caregiver mental health (adjusted odds ratio = 3.59, 95% confidence interval: 1.38, 9.31). When using  Intent to Attend  as an auxiliary variable, similar results were obtained when compared with the original treatment effect estimates on the primary outcomes.
CONCLUSION


Contrary to prior adult studies, there is no clear relationship between caregiver intentions and study compliance. Findings elucidate the complexities of caregiver-child interactions during pediatric trial participation.",2020,"Low intentions to complete the study were associated with a more than 60% lower odds of study non-completion, but the confidence interval included the null (odds ratio: 0.36; 95% confidence interval: 0.11, 1.20).",['preterm toddlers'],[],"['caregiver mental health, child sex, or annual income', 'child sex and caregiver mental health']","[{'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}]",[],"[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}]",316.0,0.224541,"Low intentions to complete the study were associated with a more than 60% lower odds of study non-completion, but the confidence interval included the null (odds ratio: 0.36; 95% confidence interval: 0.11, 1.20).","[{'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'Sullivan', 'Affiliation': ""The Research Institute, Center for Biobehavioral Health, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Wiese', 'Affiliation': ""The Research Institute, Center for Biobehavioral Health, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Boone', 'Affiliation': ""The Research Institute, Center for Biobehavioral Health, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rausch', 'Affiliation': ""The Research Institute, Center for Biobehavioral Health, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Keim', 'Affiliation': ""The Research Institute, Center for Biobehavioral Health, Nationwide Children's Hospital, Columbus, OH, USA.""}]","Clinical trials (London, England)",['10.1177/1740774519893307']
1890,32129851,Does improving appropriate use of malaria medicines change population beliefs in testing and treatment? Evidence from a randomized controlled trial.,"A major puzzle in malaria treatment remains the dual problem of underuse and overuse of malaria medications, which deplete scarce public resources used for subsidies and lead to drug resistance. One explanation is that health behaviour, especially in the context of incomplete information, could be driven by beliefs, pivotal to the success of health interventions. The objective of this study is to investigate how population beliefs change in response to an experimental intervention which was shown to improve access to rapid diagnostic testing (RDT) through community health workers (CHWs) and to increase appropriate use of anti-malaria medications. By collecting data on individuals' beliefs on malaria testing and treatment 12 and 18 months after the experimental intervention started, we find that the intervention increases the belief that a negative test result is correct, and the belief that the first-line anti-malaria drugs (artemisinin-based combination therapies or ACTs) are effective. Using mediation analysis, we also explore some possible mechanisms through which the changes happen. We find that the experience and knowledge about RDT and experience with CHWs explain 62.4% of the relationship between the intervention and the belief that a negative test result is correct. Similarly, the targeted use of ACTs and taking the correct dose-in addition to experience with RDT-explain 96.8% of the relationship between the intervention and the belief that the ACT taken is effective. As beliefs are important determinants of economic behaviour and might guide individuals' future decisions, understanding how they change after a health intervention has important implications for long-term changes in population behaviour.",2020,"By collecting data on individuals' beliefs on malaria testing and treatment 12 and 18 months after the experimental intervention started, we find that the intervention increases the belief that a negative test result is correct, and the belief that the first-line anti-malaria drugs (artemisinin-based combination therapies or ACTs) are effective.",[],[],[],[],[],[],,0.0229243,"By collecting data on individuals' beliefs on malaria testing and treatment 12 and 18 months after the experimental intervention started, we find that the intervention increases the belief that a negative test result is correct, and the belief that the first-line anti-malaria drugs (artemisinin-based combination therapies or ACTs) are effective.","[{'ForeName': 'Elisa M', 'Initials': 'EM', 'LastName': 'Maffioli', 'Affiliation': 'Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Mohanan', 'Affiliation': 'Sanford School of Public Policy, Duke University, Durham, NC 27708, USA.'}, {'ForeName': 'Indrani', 'Initials': 'I', 'LastName': 'Saran', 'Affiliation': 'Boston College School of Social Work, Boston, MA 02467, USA.'}, {'ForeName': 'Wendy Prudhomme', 'Initials': 'WP', 'LastName': ""O'Meara"", 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC 27708, USA.'}]",Health policy and planning,['10.1093/heapol/czaa010']
1891,32193277,Maximising trichiasis surgery success (MTSS) trial: rationale and design of a randomised controlled trial to improve trachomatous trichiasis surgical outcomes.,"INTRODUCTION


Trachomatous trichiasis (TT) is a condition in which the eyelid turns inward and eyelashes abrade the front part of the eye. To prevent eventual blindness, surgery is recommended. Two surgical procedures are commonly used, bilamellar tarsal rotation (BLTR) and posterior lamellar tarsal rotation (PLTR). Evidence suggests that incision height and surgery type may affect the risk of postoperative TT (PTT) and other surgical outcomes. However, these studies have not prospectively compared the impact of incision height on surgical outcomes.
METHODS AND ANALYSIS


Maximising trichiasis surgery Success (MTSS) is a three-arm, randomised clinical trial being conducted in Ethiopia. Participants will be randomly assigned on a 1:1:1 basis to BLTR with a 3 mm incision height, BLTR with a 5 mm incision height, or PLTR 3 mm incision height. Patients are eligible for the trial if they have previously unoperated upper eyelid TT. Follow-up visits will be conducted by trained eye examiners at 1 day, 2 weeks, 6 weeks and 12 months after surgery. The primary outcome is incident PTT within 1 year following surgery. Logistic regression will be used in an intention-to-treat analysis to assess outcome incidence by surgical approach.
ETHICS AND DISSEMINATION


The University of North Carolina and Johns Hopkins School of Medicine institution review boards, Ethiopian National Research Ethics Review Committee and Ethiopian Food, Medicine, Healthcare and Administration and Control Authority provided ethics approval for the trial. On completion, trial results will be disseminated at local and international meetings and in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT03100747.",2020,Evidence suggests that incision height and surgery type may affect the risk of postoperative TT (PTT) and other surgical outcomes.,[],"['Trachomatous trichiasis (TT', 'Maximising trichiasis surgery Success (MTSS', 'BLTR with a 3 mm incision height, BLTR with a 5 mm incision height, or PLTR 3 mm incision height']","['risk of postoperative TT (PTT', 'incident PTT within 1 year following surgery', 'bilamellar tarsal rotation (BLTR) and posterior lamellar tarsal rotation (PLTR']",[],"[{'cui': 'C0221259', 'cui_str': 'Trichiasis'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}]",,0.359538,Evidence suggests that incision height and surgery type may affect the risk of postoperative TT (PTT) and other surgical outcomes.,"[{'ForeName': 'Belay', 'Initials': 'B', 'LastName': 'Bayissasse', 'Affiliation': 'Orbis International Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Sullivan', 'Affiliation': 'Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Shannath L', 'Initials': 'SL', 'LastName': 'Merbs', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Munoz', 'Affiliation': 'Department of Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Keil', 'Affiliation': 'Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Alemayehu', 'Initials': 'A', 'LastName': 'Sisay', 'Affiliation': 'Orbis International Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Singer', 'Affiliation': 'Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Emily W', 'Initials': 'EW', 'LastName': 'Gower', 'Affiliation': 'Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA egower@unc.edu.'}]",BMJ open,['10.1136/bmjopen-2019-036327']
1892,31974920,Effect of adjunctive tobramycin inhalation versus placebo on early clinical response in the treatment of ventilator-associated pneumonia: the VAPORISE randomized-controlled trial.,,2020,,['ventilator-associated pneumonia'],['adjunctive tobramycin inhalation versus placebo'],[],"[{'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.218743,,"[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Stokker', 'Affiliation': 'Department of Pulmonary Medicine, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Karami', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Rogier', 'Initials': 'R', 'LastName': 'Hoek', 'Affiliation': 'Department of Pulmonary Medicine, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Diederik', 'Initials': 'D', 'LastName': 'Gommers', 'Affiliation': 'Department of Intensive Care, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Menno', 'Initials': 'M', 'LastName': 'van der Eerden', 'Affiliation': 'Department of Pulmonary Medicine, Erasmus MC, Rotterdam, The Netherlands. m.vandereerden@erasmusmc.nl.'}]",Intensive care medicine,['10.1007/s00134-019-05914-5']
1893,4572051,A comparative double-blind evaluation of iprindole and imipramine in the treatment of depressive states.,,1973,,['depressive states'],['iprindole and imipramine'],[],[],"[{'cui': 'C0022057', 'cui_str': 'Iprindole'}, {'cui': 'C0020934', 'cui_str': 'Imipramine'}]",[],,0.201668,,"[{'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Narayanan', 'Affiliation': ''}, {'ForeName': 'G N', 'Initials': 'GN', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Rao', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1894,32134289,Performance feedback during writing instruction: A cost-effectiveness analysis.,"Students in K-12 settings experience poor writing outcomes, with less than 30% of students writing at the proficient level. Coupled with the pressure to improve academic outcomes with limited resources, schools are in dire need of efficient, universally provided instructional activities that promote writing skills. Performance feedback on writing fluency was designed to be a brief, low-resource universally provided instructional activity to facilitate writing development and has demonstrated moderate to large effects on formative writing measures. The current study was conducted to directly evaluate the extent to which performance feedback on writing fluency is cost-effective. This study uses the ingredients method to estimate the costs of providing performance feedback on writing fluency and calculates incremental cost-effectiveness ratios based on secondary data from a randomized controlled trial. Results suggest that performance feedback is more cost-effective than comprehensive systems reform initiatives and comparable to other universally provided interventions, and therefore should be considered a cost-effective approach to improve writing fluency for all students. Results provide school psychologists with concrete examples of how to support prevention and intervention activities aimed to improve student writing outcomes. Limitations and suggestions for future research are also discussed. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Results suggest that performance feedback is more cost-effective than comprehensive systems reform initiatives and comparable to other universally provided interventions, and therefore should be considered a cost-effective approach to improve writing fluency for all students.",[],[],"['writing fluency', 'Performance feedback', 'writing fluency and calculates incremental cost-effectiveness ratios']",[],[],"[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0202557,"Results suggest that performance feedback is more cost-effective than comprehensive systems reform initiatives and comparable to other universally provided interventions, and therefore should be considered a cost-effective approach to improve writing fluency for all students.","[{'ForeName': 'Courtenay A', 'Initials': 'CA', 'LastName': 'Barrett', 'Affiliation': 'Department of Counseling, Educational Psychology, and Special Education, Michigan State University.'}, {'ForeName': 'Adrea J', 'Initials': 'AJ', 'LastName': 'Truckenmiller', 'Affiliation': 'Department of Counseling, Educational Psychology, and Special Education, Michigan State University.'}, {'ForeName': 'Tanya L', 'Initials': 'TL', 'LastName': 'Eckert', 'Affiliation': 'Department of Psychology, Syracuse University.'}]","School psychology (Washington, D.C.)",['10.1037/spq0000356']
1895,31407775,The Effects of Vibration and Pressure Treatments in the Early Postoperative Period of Rhinoplasty.,"BACKGROUND


The early postoperative period can be distressing for the patients undergoing rhinoplasty since edema and ecchymosis are common complications.
OBJECTIVES


To analyze the effects of the vibration and pressure treatments in the early postoperative period of rhinoplasty.
METHODS


Sixty patients, who had undergone rhinoplasty, were randomized into 3 groups: group 1 (control group, n = 20) received classic nasal casting, group 2 (n = 20) received nasal cast with an elastic bandage to hold it on the face, and group 3 (n = 20) received vibration treatment in addition to that in group 2 following the rhinoplasty. They were evaluated preoperatively and postoperatively at 3 and 7 days in a prospective study. The postoperative edema and ecchymosis were scored by 2 independent surgeons. The postoperative pain was measured using the visual analog scale, and the necessity of anti-inflammatory medication (and the dose needed) and the cast comfort was questioned. The sebaceous activity of the nose skin was examined. A preoperative and postoperative seventh day sonographic study was performed to evaluate the tissue edema objectively.
RESULTS


The pressure treatment decreased the edema and ecchymosis significantly compared with the control group. The vibration treatment minimized edema, ecchymosis, sebaceous activity of the nose skin, pain score, and the need for anti-inflammatory medication, and increased the cast comfort significantly compared with the other groups (P < 0.0001).
CONCLUSIONS


Rapid regression of edema and ecchymosis may be achieved using the vibrating nasal cast technique that may minimize patient discomfort, pain, and sebaceous activity following rhinoplasty.
LEVEL OF EVIDENCE: 1


",2020,"The vibration treatment minimized edema, ecchymosis, sebaceous activity of the nose skin, pain score, and the need for anti-inflammatory medication, and increased the cast comfort significantly compared with the other groups (p < 0.0001).
","['Sixty patients, who had undergone rhinoplasty', 'Early Postoperative Period of Rhinoplasty']","['vibration treatment', 'Vibration and Pressure Treatments', 'classic nasal casting', 'nasal cast with an elastic bandage']","['cast comfort', 'postoperative pain', 'postoperative edema and ecchymosis', 'edema, ecchymosis, sebaceous activity of the nose skin, pain score, and the need for anti-inflammatory medication', 'tissue edema objectively', 'edema and ecchymosis', 'sebaceous activity of the nose skin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035467', 'cui_str': 'Plastic operation on nose'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment (regime/therapy)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0336591', 'cui_str': 'Elastic bandage'}]","[{'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0028429', 'cui_str': 'Nose'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}]",60.0,0.0139174,"The vibration treatment minimized edema, ecchymosis, sebaceous activity of the nose skin, pain score, and the need for anti-inflammatory medication, and increased the cast comfort significantly compared with the other groups (p < 0.0001).
","[{'ForeName': 'Süleyman', 'Initials': 'S', 'LastName': 'Taş', 'Affiliation': ''}]",Aesthetic surgery journal,['10.1093/asj/sjz226']
1896,31233255,Ziconotide for spinal cord injury-related pain.,"BACKGROUND


Central neuropathic pain related to spinal cord injury is notoriously difficult to treat. So far most pharmacological and surgical options have shown but poor results. Recently ziconotide has been approved for use both neuropathic and non-neuropathic pain. In this cohort study, we assessed responder rate and long-term efficacy of intrathecal ziconotide in patients with pain related to spinal cord injury.
METHODS


Patients presenting chronic neuropathic related to spinal cord lesions that was refractory to medical pain management were considered for inclusion. Those accepting were tested by lumbar puncture injection of ziconotide or continuous intrathecal infusion and if a significant decrease in pain scores (>40%) was noted they were implanted with a continuous infusion pump. They were then followed up for at least 1 year with constant assessment of the evolution of pain and side effects.
RESULTS


Out of the 20 patients tested 14 had a decrease in pain scores of more than 40% but only 11 (55%) were implanted with permanent pumps due to side effects and patient choice. These were followed up on average for 3.59 years (±1.94) and in eight patients an above threshold decrease in pain scores was maintained. Overall in patients that responded to the test baseline VAS was 7.91 and 4.31 at last follow-up with an average dose of 7.2 μg of ziconotide per day. Six patients (30%) did not respond to any test and in three patients side effects precluded pump implantation. No significant long-term effects of the molecule were noted.
CONCLUSION


This study shows response to intrathecal ziconotide test in 40% of the patients of a very specific population in whom other therapeutic options are not available. This data justifies the development further studies such as a long-term randomized controlled trial.
SIGNIFICANCE


Intrathecal Ziconotide is a posible alternative for the treatment of pain in patients with spinal cord injury and below level neuropathic pain.",2019,"No significant long term effects of the molecule were noted.
","['patients with pain related to spinal cord injury', 'Patients presenting chronic neuropathic related to spina cord lesions that was refractory to medical pain management were considered for inclusion', '40% of the patients of a very specific population in whom other therapeutic options are not available']","['Ziconotide', 'intrathecal ziconotide']",['pain scores'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0211011', 'cui_str': 'ziconotide'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",,0.288106,"No significant long term effects of the molecule were noted.
","[{'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Brinzeu', 'Affiliation': 'Neurosurgical Department, Pierre Wertheimer Hospital, Hospices Civils de Lyon, Lyon 1 University, Lyon, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Berthiller', 'Affiliation': 'Neurosurgical Department, Pierre Wertheimer Hospital, Hospices Civils de Lyon, Lyon 1 University, Lyon, France.'}, {'ForeName': 'Jean-Bernard', 'Initials': 'JB', 'LastName': 'Caillet', 'Affiliation': 'Pain Center, ""Pierre Wertheimer"" Hospital, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Staquet', 'Affiliation': 'Neurosurgical Department, Pierre Wertheimer Hospital, Hospices Civils de Lyon, Lyon 1 University, Lyon, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mertens', 'Affiliation': 'Neurosurgical Department, Pierre Wertheimer Hospital, Hospices Civils de Lyon, Lyon 1 University, Lyon, France.'}]","European journal of pain (London, England)",['10.1002/ejp.1445']
1897,31586371,Photogrammetric Analysis of Upper Cross Syndrome among Teachers and the Effects of National Academy of Sports Medicine Exercises with Ergonomic Intervention on the Syndrome.,"BACKGROUND


Hyperkyphosis is often accompanied by forward head and shoulder postures. Together, these three disorders are called ""Upper Cross Syndrome (UCS)"". We aimed to perform a photogrammetric analysis of UCS among teachers and to determine the effects of National Academy of Sports Medicine (NASM) exercises with ergonomic training interventions on the syndrome.
STUDY DESIGN


A semi-experimental study.
METHODS


Photogrammetric analysis was performed using the UCS software among teachers in order to determine the angles of forward head, rounded shoulders, and hyperkyphosis. Twenty-three teachers were selected purposefully and enrolled in Fasa City in 2018. They were randomly divided into experimental (n=12) and control (n=11) groups. Experimental group attended 12 wk of NASM exercises with ergonomic intervention but the control group did not participate in any regular exercise. The data were analyzed using paired t-test and differential independent t-test (P<0.05).
RESULTS


The results indicated a significant decrease in forward head (P=0.001), shoulder angles (P=0.000) and hyperkyphosis (P=0.003). The applied intervention had a 90% positive effect in reducing the forward head angle, an 88% positive effect in reducing the rounded shoulder angle and a 90% positive effect in reducing the kyphosis angle. However, the results for the control group did not show a significant difference for forward head, rounded shoulders, and hyperkyphosis angles.
CONCLUSION


The UCS software application can be used as an accurate instrument for measuring the extent of the UCS. Moreover, using NASM exercises can lead to a reduction in the UCS among teachers.",2019,"The results indicated a significant decrease in forward head (P=0.001), shoulder angles (P=0.000) and hyperkyphosis (P=0.003).",['Twenty-three teachers were selected purposefully and enrolled in Fasa City in 2018'],"['NASM exercises', 'NASM exercises with ergonomic intervention but the control group did not participate in any regular exercise', 'Sports Medicine Exercises with Ergonomic Intervention', 'Sports Medicine (NASM) exercises with ergonomic training interventions']","['kyphosis angle', 'forward head', 'shoulder angles', 'rounded shoulder angle']","[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0086246', 'cui_str': 'Ergonomics'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}, {'cui': 'C0038040', 'cui_str': 'Sports Medicine'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0022823'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}]",23.0,0.0166266,"The results indicated a significant decrease in forward head (P=0.001), shoulder angles (P=0.000) and hyperkyphosis (P=0.003).","[{'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Karimian', 'Affiliation': 'Department of Sports Injuries and Corrective Exercises, School of Sport Sciences, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Rahnama', 'Affiliation': 'Department of Sports Injuries and Corrective Exercises, School of Sport Sciences, University of Isfahan, Isfahan, Iran. rahnamanader@yahoo.com.'}, {'ForeName': 'Gholamali', 'Initials': 'G', 'LastName': 'Ghasemi', 'Affiliation': 'Department of Sports Injuries and Corrective Exercises, School of Sport Sciences, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Lenjannejadian', 'Affiliation': 'Department of Sports Injuries and Corrective Exercises, School of Sport Sciences, University of Isfahan, Isfahan, Iran.'}]",Journal of research in health sciences,[]
1898,31586376,Examining the Effectiveness of a Web-Based Intervention for Depressive Symptoms in Female Adolescents: Applying Social Cognitive Theory.,"BACKGROUND


Depression is a serious mental health illness among adolescents especially girls. Web-based treatment can possibly become a solution for reducing mental health problems in adolescents. This study is one of the first trials aimed to evaluate the efficiency of web-based depression improvement program among female adolescents based on the Social Cognitive Theory (SCT).
STUDY DESIGN


Randomized Controlled Trial.
METHODS


A six-month randomized controlled trial based on the SCT was implemented in female schools in Hamadan City, west of Iran in 2018 on 128 female students with mild to moderate depressive symptoms (CES-D =10-45). They were randomly assigned to either intervention or control group (n= 64 in each group). Depression improvement program was implemented through the website via short videos, animations and Power-Point slides. Depression was evaluated using Center for Epidemiologic Depression Scale. A researcher-made questionnaire based on the sheerer and Perceived-Social-Support-Scale-Revised (PSSS-R) questionnaires were used to evaluate the SCT constructs. The data were analyzed using SPSS software.
RESULTS


The intervention program resulted in the improvement of depression in 12 wk based on Intent-to-treat analyses. Nevertheless, these achievements seem to have decreased by 24 wk in intervention group. The intervention increased the mean scores of the constructs of social support and self-regulation from baseline to 12 wk in the intervention group (P<0.05). The intervention had no effect on outcome expectations and self-efficacy. There were no statistically significant associated between theory constructs changes and changes in depression (P>0.05).
CONCLUSION


The web-based intervention improved depression in female students. Future training using strategies for the sustainable improvement of depression in female students are needed.",2019,The intervention increased the mean scores of the constructs of social support and self-regulation from baseline to 12 wk in the intervention group (P<0.05).,"['adolescents', 'female adolescents', 'female schools in Hamadan City, west of Iran in 2018 on 128 female students with mild to moderate depressive symptoms (CES-D =10-45', 'female students', 'adolescents especially girls', 'Female Adolescents']","['Social Cognitive Theory (SCT', 'Web-Based Intervention', 'SCT', 'web-based depression improvement program']","['improvement of depression', 'Depression', 'mean scores of the constructs of social support and self-regulation', 'sheerer and Perceived-Social-Support-Scale-Revised (PSSS-R) questionnaires', 'outcome expectations and self-efficacy']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037438'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",128.0,0.0327302,The intervention increased the mean scores of the constructs of social support and self-regulation from baseline to 12 wk in the intervention group (P<0.05).,"[{'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Moeini', 'Affiliation': 'Social Determinants of Health Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Bashirian', 'Affiliation': 'Social Determinants of Health Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Ali Reza', 'Initials': 'AR', 'LastName': 'Soltanian', 'Affiliation': 'Modeling of Noncommunicable Diseases Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ghaleiha', 'Affiliation': 'Research Center for Behavioral Disorders and Substances Abuse, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Taheri', 'Affiliation': 'Department of Public Health, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran. ma.taheri@umsha.ac.ir.'}]",Journal of research in health sciences,[]
1899,31586377,The Effect of Exercise Plan Based on FITT Protocol on Primary Dysmenorrhea in Medical Students: A Clinical Trial Study.,"BACKGROUND


We aimed to investigate the effects of exercise based on a specific protocol on the severity and duration of primary dysmenorrhea in students residing in dormitories of Hamadan University of Medical Sciences, western Iran in 2017.
STUDY DESIGN


Randomized controlled trial study.
METHODS


Overall, 86 students (43 in the interventional group and 43 in the control group) with mild to moderate dysmenorrhea were enrolled. The exercise based on the FITT protocol (Intensity of exercise, time of exercise, and type of exercise) was implemented for the interventional group in 8 weeks. The McGill Pain scale was used to determine the severity of pain in dysmenorrhea. Duration of pain was calculated in terms of the day. Research data were analyzed using SPSS 20 and the significance level was considered 0.05.
RESULTS


The mean dysmenorrhea severity in the first menstrual cycle after the intervention in intervention group was significantly lower than the control group (3.06 (1.78) and 4.74 (2.14), respectively) and in the second menstrual cycle (2.01 (1.54) and 4.61 (2.01) respectively) (P<0.001). The mean duration of dysmenorrhea in the first menstrual cycle after the intervention in intervention group was less than the control group (1.29 (0.92) and 2.32 (1.26) respectively) P<0.001) and in the second menstrual cycle (0.94 (0.93) and 2.13 (1.24) respectively) P<0.001).
CONCLUSION


Sports activities based on a certain and organized protocol could improve dysmenorrhea.",2019,"The mean dysmenorrhea severity in the first menstrual cycle after the intervention in intervention group was significantly lower than the control group (3.06 (1.78) and 4.74 (2.14), respectively) and in the second menstrual cycle (2.01 (1.54) and 4.61 (2.01) respectively)","['students residing in dormitories of Hamadan University of Medical Sciences, western Iran in 2017', 'Primary Dysmenorrhea in Medical Students', '86 students (43 in the interventional group and 43 in the control group) with mild to moderate dysmenorrhea were enrolled']","['FITT protocol (Intensity of exercise, time of exercise, and type of exercise', 'Exercise Plan Based on FITT Protocol']","['McGill Pain scale', 'dysmenorrhea', 'mean duration of dysmenorrhea', 'mean dysmenorrhea severity', 'Duration of pain', 'severity of pain in dysmenorrhea']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea (disorder)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}]","[{'cui': 'C0060398', 'cui_str': 'FITT'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0024985', 'cui_str': 'McGill Pain Questionnaire'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0362516,"The mean dysmenorrhea severity in the first menstrual cycle after the intervention in intervention group was significantly lower than the control group (3.06 (1.78) and 4.74 (2.14), respectively) and in the second menstrual cycle (2.01 (1.54) and 4.61 (2.01) respectively)","[{'ForeName': 'Rashid', 'Initials': 'R', 'LastName': 'Heidarimoghadam', 'Affiliation': 'Research Center for Health Sciences, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Elaheh', 'Initials': 'E', 'LastName': 'Abdolmaleki', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Farideh', 'Initials': 'F', 'LastName': 'Kazemi', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Seyedeh Zahra', 'Initials': 'SZ', 'LastName': 'Masoumi', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran. zahramid2001@gmail.com.'}, {'ForeName': 'Batoul', 'Initials': 'B', 'LastName': 'Khodakarami', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Younes', 'Initials': 'Y', 'LastName': 'Mohammadi', 'Affiliation': 'Modeling of Noncommunicable Disease Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Journal of research in health sciences,[]
1900,32107748,Evaluation of Mortality During Long-Term Treatment with Tafamidis for Transthyretin Amyloidosis with Polyneuropathy: Clinical Trial Results up to 8.5 Years.,"INTRODUCTION


The effects of tafamidis on mortality in Val30Met and non-Val30Met patients with transthyretin amyloidosis with polyneuropathy (ATTR-PN) were evaluated.
METHODS


The analyses were based on cumulative data from the Val30Met patients in the 18-month double-blind registration study and its 12-month open-label extension study, the non-Val30Met patients of the 12-month open-label study, and both patient groups in the ongoing 10-year extension study. Kaplan-Meier analyses of time to death from first treatment dose were performed. For the Val30Met group, two treatment groups were analyzed: those who received tafamidis in both the parent and extension studies (T-T) and those who received placebo in the parent study and switched to tafamidis in the extension studies (P-T).
RESULTS


Kaplan-Meier estimates (95% confidence interval [CI]) were available up to 9 years for the Val30Met group, at which time 85.9% (53.1-96.4) and 91.1% (77.9-96.6) of the patients in the T-T and P-T groups, respectively, were alive. For the non-Val30Met group, estimates were available up to 8 years from the first dose, and the percentage of patients alive was 75.9% (47.7-90.2).
CONCLUSION


Long-term tafamidis treatment may confer survival benefit in patients with ATTR-PN.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT00409175, NCT00791492, NCT00630864, and NCT00925002.",2020,"The effects of tafamidis on mortality in Val30Met and non-Val30Met patients with transthyretin amyloidosis with polyneuropathy (ATTR-PN) were evaluated.
","['patients with ATTR-PN', 'Val30Met and non-Val30Met patients with transthyretin amyloidosis with polyneuropathy (ATTR-PN']",['placebo'],"['Mortality', 'survival benefit', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2751492', 'cui_str': 'Familial Transthyretin Cardiac Amyloidosis'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.05698,"The effects of tafamidis on mortality in Val30Met and non-Val30Met patients with transthyretin amyloidosis with polyneuropathy (ATTR-PN) were evaluated.
","[{'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Merlini', 'Affiliation': 'Foundation IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Coelho', 'Affiliation': ""Andrade's Centre, Hospital Santo António, Centro Hospitalar do Porto, Porto, Portugal.""}, {'ForeName': 'Márcia', 'Initials': 'M', 'LastName': 'Waddington Cruz', 'Affiliation': 'CEPARM National Amyloidosis Referral Center, University Hospital, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Huihua', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Stewart', 'Affiliation': 'Pfizer Inc, New York, NY, USA. michelle.stewart@pfizer.com.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Ebede', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}]",Neurology and therapy,['10.1007/s40120-020-00180-w']
1901,31628428,Long-term efficacy and safety of first-line ibrutinib treatment for patients with CLL/SLL: 5 years of follow-up from the phase 3 RESONATE-2 study.,"RESONATE-2 is a phase 3 study of first-line ibrutinib versus chlorambucil in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Patients aged ≥65 years (n = 269) were randomized 1:1 to once-daily ibrutinib 420 mg continuously or chlorambucil 0.5-0.8 mg/kg for ≤12 cycles. With a median (range) follow-up of 60 months (0.1-66), progression-free survival (PFS) and overall survival (OS) benefits for ibrutinib versus chlorambucil were sustained (PFS estimates at 5 years: 70% vs 12%; HR [95% CI]: 0.146 [0.098-0.218]; OS estimates at 5 years: 83% vs 68%; HR [95% CI]: 0.450 [0.266-0.761]). Ibrutinib benefit was also consistent in patients with high prognostic risk (TP53 mutation, 11q deletion, and/or unmutated IGHV) (PFS: HR [95% CI]: 0.083 [0.047-0.145]; OS: HR [95% CI]: 0.366 [0.181-0.736]). Investigator-assessed overall response rate was 92% with ibrutinib (complete response, 30%; 11% at primary analysis). Common grade ≥3 adverse events (AEs) included neutropenia (13%), pneumonia (12%), hypertension (8%), anemia (7%), and hyponatremia (6%); occurrence of most events as well as discontinuations due to AEs decreased over time. Fifty-eight percent of patients continue to receive ibrutinib. Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.",2020,Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.,"['patients with CLL/SLL', 'chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL', 'Patients aged ≥65 years (n\u2009=\u2009269']","['daily ibrutinib 420\u2009mg continuously or chlorambucil 0.5-0.8\u2009mg/kg for ≤12 cycles', 'first-line ibrutinib treatment', 'chlorambucil']","['hyponatremia', 'Investigator-assessed overall response rate', 'progression-free survival (PFS) and overall survival (OS) benefits', 'anemia', 'pneumonia', 'neutropenia', 'hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0024303', 'cui_str': 'Lymphocytic lymphoma'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4555385', 'cui_str': 'Ibrutinib 420 MG'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",,0.152562,Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.,"[{'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Burger', 'Affiliation': 'Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA. jaburger@mdanderson.org.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Barr', 'Affiliation': 'Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Robak', 'Affiliation': 'Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Owen', 'Affiliation': 'Tom Baker Cancer Centre, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ghia', 'Affiliation': 'Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Tedeschi', 'Affiliation': 'ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.'}, {'ForeName': 'Osnat', 'Initials': 'O', 'LastName': 'Bairey', 'Affiliation': 'Rabin Medical Center, Petah Tikva, Israel and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': 'The Leeds Teaching Hospitals, St. James Institute of Oncology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Coutre', 'Affiliation': 'Stanford Cancer Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Devereux', 'Affiliation': 'Kings College Hospital, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Grosicki', 'Affiliation': 'Department of Hematology and Cancer Prevention, Silesiam Medical University, Katowice, Poland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McCarthy', 'Affiliation': 'Royal Bournemouth General Hospital, Bournemouth, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simpson', 'Affiliation': 'North Shore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Offner', 'Affiliation': 'Universitair Ziekenhuis Gent, Gent, Belgium.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Moreno', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Dai', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Indu', 'Initials': 'I', 'LastName': 'Lal', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Dean', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Kipps', 'Affiliation': 'UCSD Moores Cancer Center, San Diego, CA, USA.'}]",Leukemia,['10.1038/s41375-019-0602-x']
1902,32074663,"Efficacy and safety of twice a day, bismuth-containing quadruple therapy using high-dose tetracycline and metronidazole for second-line Helicobacter pylori eradication.","BACKGROUND/AIMS


Conventional second-line, bismuth-containing quadruple therapy is administered four times a day. We aimed to evaluate the efficacy and safety of twice a day administration compared to the four times a day therapy.
METHODS


Medical records of consecutive patients with positive  13  C-urea breath tests (UBTs) after first-line eradication were reviewed. From December 2018 to June 2019, 100 consecutive  13  C-UBT-positive patients received tetracycline 1 g, metronidazole 750 mg, bismuth subcitrate 300 mg, and pantoprazole 20 mg twice a day for one week. The same number of consecutive 13  C-UBT-positive patients before December 2018 was included as controls. The control group received tetracycline 500 mg and bismuth subcitrate 300 mg four times a day, metronidazole 500 mg three times a day, and pantoprazole 20 mg twice a day for one week. Eradication was confirmed based on a  13  C-UBT performed in the 5th week after taking quadruple therapy.
RESULTS


Ninety-eight patients from the twice a day group and 99 patients from the four times a day group were analyzed. The eradication rate did not differ between the twice a day group (92/98, 93.9%) and the four times a day group (92/99, 92.9%). Adverse drug effects were found in 36 patients from the twice a day group and 50 patients from the four times a day group (P = .051). Abdominal pain, discomfort, and distention were more common with four times a day intake (13.1%) than with twice a day intake (4.1%; P = .024).
CONCLUSIONS


We determined for the first time that twice a day intake of bismuth-containing quadruple therapy using 2 g/d of tetracycline, 1.5 g/d of metronidazole, and 600 mg/d of bismuth subcitrate for one week is effective and safe as the conventional four times a day therapy. Twice a day intake decreased abdominal pain, discomfort, and distention.",2020,Adverse drug effects were found in 36 patients from the twice a day group and 50 patients from the four times a day group (P = .051).,"['From December 2018 to June 2019, 100 consecutive  13  C-UBT-positive patients received', 'Medical records of consecutive patients with positive  13  C-urea breath tests (UBTs) after first-line eradication were reviewed']","['tetracycline 1\xa0g, metronidazole 750\xa0mg, bismuth subcitrate 300\xa0mg, and pantoprazole', 'tetracycline, 1.5\xa0g/d of metronidazole, and 600\xa0mg/d of bismuth subcitrate', 'metronidazole', 'tetracycline and metronidazole', 'pantoprazole', 'tetracycline 500\xa0mg and bismuth subcitrate']","['efficacy and safety', 'Abdominal pain, discomfort, and distention', 'Efficacy and safety', 'Adverse drug effects', 'eradication rate', 'abdominal pain, discomfort, and distention', 'Eradication']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0729631', 'cui_str': 'C-13 isotope'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025102', 'cui_str': 'Medical Records'}, {'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C0006153', 'cui_str': 'Breath Tests'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}]","[{'cui': 'C0039651', 'cui_str': 'Tetracyclines'}, {'cui': 'C1829251', 'cui_str': 'Metronidazole 750 MG [Flagyl]'}, {'cui': 'C0106556', 'cui_str': 'bismuth subcitrate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0081876', 'cui_str': 'pantoprazole'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1123624', 'cui_str': 'Tetracycline 500 MG'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C3714614', 'cui_str': 'Distention'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}]",98.0,0.0241937,Adverse drug effects were found in 36 patients from the twice a day group and 50 patients from the four times a day group (P = .051).,"[{'ForeName': 'Ji Yeon', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Sun-Young', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jeong Hwan', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea.'}, {'ForeName': 'In-Kyung', 'Initials': 'IK', 'LastName': 'Sung', 'Affiliation': 'Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyung Seok', 'Initials': 'HS', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea.'}]",Helicobacter,['10.1111/hel.12683']
1903,32089822,A phase IIb study to determine the safety and efficacy of candidate INfluenza Vaccine MVA-NP+M1 in combination with licensed Ina CTivated infl Uenza vaccine in adult S aged 65 years and above (INVICTUS): a study protocol.,"Seasonal influenza has a significant annual global impact. Current influenza vaccines work by inducing strain-specific antibodies against the highly polymorphic surface proteins of the influenza virus and need to be redesigned every year, increasing their cost and limiting availability. There is a demand for a more efficacious vaccine, particularly in older adults in which the current vaccines show poor efficacy. The aim is to investigate a novel vaccine, MVA-NP+M1, which targets T cell responses to the nucleoprotein and matrix 1 core proteins of the influenza virus A, which are highly conserved,    and therefore may provide long protection against a broad range of influenza strains. INVICTUS is a phase IIb study to determine the safety and efficacy of candidate INfluenza Vaccine MVA-NP+M1 in combination with licensed Ina CTivated infl Uenza vaccine in adult S aged 65 years and above is a randomised, participant-blinded, placebo-controlled, multi-centre phase IIb efficacy study planned for 2030 volunteers aged 65 and over, in primary care. The primary objective is to assess the efficacy of MVA-NP+M1 co-administered with licensed inactivated quadrivalent influenza vaccine in adults ≥65 years. Participants complete daily diaries to record solicited and unsolicited events in the first four weeks post vaccination, and influenza-like illness (ILI) symptoms and severity throughout the influenza season. We hypothesise an improvement in the primary outcome, a reduction in the average number of days spent with moderate or severe influenza-like illness during periods of influenza circulation, in the group administered with MVA-NP+M1, compared to those in the control group.  Registration:  ClinicalTrials.gov identifier NCT03300362.  Protocol version:  INVICTUS Protocol v3.0, 08 June06 2018.",2019,"We hypothesise an improvement in the primary outcome, a reduction in the average number of days spent with moderate or severe influenza-like illness during periods of influenza circulation, in the group administered with MVA-NP+M1, compared to those in the control group.  ","['adult S aged 65 years', 'adult S aged 65 years and above (INVICTUS', '2030 volunteers aged 65 and over, in primary care', 'older adults', 'adults ≥65 years']","['placebo', 'MVA-NP+M1 co-administered with licensed inactivated quadrivalent influenza vaccine', 'candidate INfluenza Vaccine MVA-NP+M1']","['influenza-like illness (ILI) symptoms and severity throughout the influenza season', 'average number of days spent with moderate or severe influenza-like illness', 'daily diaries to record solicited and unsolicited events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2939181', 'cui_str': 'Motor vehicle traffic accident (event)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0023636', 'cui_str': 'Permits'}, {'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C0521839', 'cui_str': 'Influenza-like illness (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",2030.0,0.0547757,"We hypothesise an improvement in the primary outcome, a reduction in the average number of days spent with moderate or severe influenza-like illness during periods of influenza circulation, in the group administered with MVA-NP+M1, compared to those in the control group.  ","[{'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Swayze', 'Affiliation': 'Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Folegatti', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, OX3 7DQ, UK.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gilbert', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, OX3 7DQ, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, OX3 7DQ, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Ellis', 'Affiliation': 'Vaccitech Limited, Heatley Road, The Oxford Science Park,, Oxford, OX4 4GE, UK.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Butler', 'Affiliation': 'Primary Care Health Sciences, University of Oxford, Oxford, UK.'}]",F1000Research,['10.12688/f1000research.19090.1']
1904,32097058,Auditory Perception and Ultrasound Biofeedback Treatment Outcomes for Children With Residual /ɹ/ Distortions: A Randomized Controlled Trial.,"Purpose This study evaluated whether outcomes from treatment, which includes ultrasound visual feedback (UVF), would be more or less effective when combined with auditory perception training for children with residual /ɹ/ errors. Method Children ages 8-16 years with /ɹ/ distortions participated in speech therapy that included real-time UVF of the tongue. Thirty-eight participants were randomized to speech therapy conditions that included a primary focus on articulation using UVF or a condition that included auditory perceptual training plus UVF (incorporating category goodness judgments and self-monitoring). Generalization of /ɹ/ production accuracy to untrained words was assessed before and after 14 hr of therapy. Additionally, the role of auditory perceptual acuity was explored using a synthetic /ɹ/-/w/ continuum. Results There was no difference between the treatment groups in rate of improvement of /ɹ/ accuracy (increase of 34% for each group;  p =  .95, η p 2  = .00). However, pretreatment auditory acuity was associated with treatment progress in both groups, with finer perceptual acuity corresponding to greater progress ( p  = .015, η p 2  = .182). Conclusion Similar gains in speech sound accuracy can be made with treatment that includes UVF with or without auditory perceptual training. Fine-grained perceptual acuity may be a prognostic indicator with treatment. Supplemental Material https://doi.org/10.23641/asha.11886219.",2020,"There was no difference between the treatment groups in rate of improvement of /ɹ/ accuracy (increase of 34% for each group;  p =  .95, η p 2  = .00).","['Thirty-eight participants', 'Method Children ages 8-16 years with /ɹ/ distortions participated in speech therapy that included real-time UVF of the tongue', 'Children With Residual /ɹ/ Distortions', 'children with residual /ɹ/ errors']","['Supplemental Material https://doi.org/10.23641/asha.11886219', 'ultrasound visual feedback (UVF', 'Auditory Perception and Ultrasound Biofeedback', 'auditory perception training', 'speech therapy conditions that included a primary focus on articulation using UVF or a condition that included auditory perceptual training plus UVF (incorporating category goodness judgments and self-monitoring']","['auditory perceptual acuity', 'rate of improvement of /ɹ/ accuracy', 'pretreatment auditory acuity']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332482', 'cui_str': 'Abnormal shape'}, {'cui': 'C0037831', 'cui_str': 'Speech Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}]","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0037831', 'cui_str': 'Speech Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0556503', 'cui_str': 'Perceptual training (regime/therapy)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0022423', 'cui_str': 'Judgment'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0679027', 'cui_str': 'Auditory acuity'}]",38.0,0.0281561,"There was no difference between the treatment groups in rate of improvement of /ɹ/ accuracy (increase of 34% for each group;  p =  .95, η p 2  = .00).","[{'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Preston', 'Affiliation': 'Department of Communication Sciences and Disorders, Syracuse University, NY.'}, {'ForeName': 'Elaine R', 'Initials': 'ER', 'LastName': 'Hitchcock', 'Affiliation': 'Department of Communication Sciences and Disorders, Montclair State University, NJ.'}, {'ForeName': 'Megan C', 'Initials': 'MC', 'LastName': 'Leece', 'Affiliation': 'Department of Communication Sciences and Disorders, Syracuse University, NY.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2019_JSLHR-19-00060']
1905,32118607,CORR Insights®: Did Osteoblastic Cell Therapy Improve the Prognosis of Pre-fracture Osteonecrosis of the Femoral Head? A Randomized Controlled Trial.,,2020,,[],"['CORR Insights®', 'Osteoblastic Cell Therapy']",[],[],"[{'cui': 'C0302189', 'cui_str': 'Cell Therapy'}]",[],,0.233149,,"[{'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Meermans', 'Affiliation': 'G. Meermans, Orthopaedic Surgeon, Bravis Hospital, Department of Orthopaedics, Bergen Op Zoom, Brabant, Netherlands.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001194']
1906,32066146,Adverse Effects of Low-Dose Methotrexate: A Randomized Trial.,"Background


Low-dose methotrexate (LD-MTX) is the most commonly used drug for systemic rheumatic diseases worldwide and is the recommended first-line agent for rheumatoid arthritis. Despite extensive clinical use for more than 30 years, few data on adverse event (AE) rates derive from randomized, placebo-controlled trials, where both causality and magnitude of risk can be inferred.
Objective


To investigate AE rates, risk, and risk differences comparing LD-MTX versus placebo.
Design


Prespecified secondary analyses of a double-blind, placebo-controlled, randomized trial. (ClinicalTrials.gov: NCT01594333).
Setting


North America.
Participants


Adults with known cardiovascular disease and diabetes or metabolic syndrome.
Intervention


Random allocation to LD-MTX (≤20 mg/wk) or placebo. All participants received folic acid, 1 mg/d, 6 days per week.
Measurements


Risks for specific AEs of interest, as well as for all AEs, were compared across treatment groups after blinded adjudication.
Results


After an active run-in period, 6158 patients were enrolled and 4786 randomly assigned to a group; median follow-up was 23 months and median dosage 15 mg/wk. Among the randomly assigned participants, 81.2% were male, median age was 65.7 years, and median body mass index was 31.5 kg/m2. Of 2391 participants assigned to LD-MTX, 2080 (87.0%) had an AE of interest, compared with 1951 of 2395 (81.5%) assigned to placebo (hazard ratio [HR], 1.17 [95% CI, 1.10 to 1.25]). The relative hazards of gastrointestinal (HR, 1.91 [CI, 1.75 to 2.10]), pulmonary (HR, 1.52 [CI, 1.16 to 1.98]), infectious (HR, 1.15 [CI, 1.01 to 1.30]), and hematologic (HR, 1.15 [CI, 1.07 to 1.23]) AEs were elevated for LD-MTX versus placebo. With the exception of increased risk for skin cancer (HR, 2.05 [CI, 1.28 to 3.28]), the treatment groups did not differ in risk for other cancer or mucocutaneous, neuropsychiatric, or musculoskeletal AEs. Renal AEs were reduced in the LD-MTX group (HR, 0.85 [CI, 0.78 to 0.93]).
Limitation


The trial was done in patients without rheumatic disease who tolerated LD-MTX during an active run-in period.
Conclusion


Use of LD-MTX was associated with small to moderate elevations in risks for skin cancer and gastrointestinal, infectious, pulmonary, and hematologic AEs, whereas renal AEs were decreased.
Primary Funding Source


National Institutes of Health.",2020,"Renal AEs were reduced in the LD-MTX group (HR, 0.85 [CI, 0.78 to 0.93]).
","['6158 patients', 'patients without rheumatic disease who tolerated LD-MTX during an active run-in period', 'randomly assigned participants, 81.2% were male, median age was 65.7 years, and median body mass index was 31.5 kg/m2', '2391 participants assigned to', 'Participants\n\n\nAdults with known cardiovascular disease and diabetes or metabolic syndrome']","['placebo', '\n\n\nLow-dose methotrexate (LD-MTX', 'LD-MTX', 'Low-Dose Methotrexate', 'LD-MTX versus placebo', 'folic acid']","['increased risk for skin cancer', 'Renal AEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035435', 'cui_str': 'Rheumatism'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}]",6158.0,0.678699,"Renal AEs were reduced in the LD-MTX group (HR, 0.85 [CI, 0.78 to 0.93]).
","[{'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Elizabeth W', 'Initials': 'EW', 'LastName': 'Karlson', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Fengxin', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Corrigan', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Colls', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'MacFadyen', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Medha', 'Initials': 'M', 'LastName': 'Barbhaiya', 'Affiliation': 'Hospital for Special Surgery, New York, New York (M.B.).'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Berliner', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Dellaripa', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Brendan M', 'Initials': 'BM', 'LastName': 'Everett', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Aruna D', 'Initials': 'AD', 'LastName': 'Pradhan', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Sarah P', 'Initials': 'SP', 'LastName': 'Hammond', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Murray', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Deepak A', 'Initials': 'DA', 'LastName': 'Rao', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Susan Y', 'Initials': 'SY', 'LastName': 'Ritter', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rutherford', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Sparks', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Stratton', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Dong H', 'Initials': 'DH', 'LastName': 'Suh', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Tedeschi', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Kathleen M M', 'Initials': 'KMM', 'LastName': 'Vanni', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Nina P', 'Initials': 'NP', 'LastName': 'Paynter', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}]",Annals of internal medicine,['10.7326/M19-3369']
1907,31402005,"Effect of in-line drinking water chlorination at the point of collection on child diarrhoea in urban Bangladesh: a double-blind, cluster-randomised controlled trial.","BACKGROUND


Previous blinded trials of household water treatment interventions in low-income settings have failed to detect a reduction in child diarrhoea. Technological advances have enabled the development of automated in-line chlorine dosers that can disinfect drinking water without electricity, while also allowing users to continue their typical water collection practices. We aimed to evaluate the effect of installing novel passive chlorination devices at shared water points on child diarrhoea prevalence in low-income, densely populated communities in urban Bangladesh.
METHODS


In this double-blind cluster-randomised controlled trial, 100 shared water points (clusters) in two low-income urban communities in Bangladesh were randomly assigned (1:1) to have their drinking water automatically chlorinated at the point of collection by a solid tablet chlorine doser (intervention group) or to be treated by a visually identical doser that supplied vitamin C (active control group). The trial followed an open cohort design; all children younger than 5 years residing in households accessing enrolled water points were measured every 2-3 months during a 14-month follow-up period (children could migrate into or out of the cluster). The primary outcome was caregiver-reported child diarrhoea (≥3 loose or watery stools in a 24-h period [WHO criteria]) with a 1-week recall, including all available childhood observations in the analyses. This trial is registered with ClinicalTrials.gov, number NCT02606981, and is completed.
FINDINGS


Between July 5, 2015, and Nov 11, 2015, 100 water points with 920 eligible households were enrolled into the study and randomly assigned to the treatment (50 water points; 517 children at baseline; 2073 child observations included in the primary analysis) or control groups (50; 519; 2154). Children in the treatment group had less WHO-defined diarrhoea than did children in the control group (control 216 [10·0%] of 2154; treatment 156 [7·5%] of 2073; prevalence ratio 0·77, 95% CI 0·65-0·91). Drinking water at the point of collection at treatment taps had detectable free chlorine residual 83% (mean 0·37 ppm) of the time compared with 0% at control taps (0·00 ppm).
INTERPRETATION


Passive chlorination at the point of collection could be an effective and scalable strategy in low-income urban settings for reducing child diarrhoea and for achieving global progress towards Sustainable Development Goal 6.1 to attain universal access to safe and affordable drinking water. Targeting a low chlorine residual (<0·5 ppm) in treated water can increase taste acceptability of chlorinated drinking water while still reducing the risk of diarrhoea.
FUNDING


The World Bank.",2019,"Children in the treatment group had less WHO-defined diarrhoea than did children in the control group (control 216 [10·0%] of 2154; treatment 156 [7·5%] of 2073; prevalence ratio 0·77, 95% CI 0·65-0·91).","['children younger than 5 years residing in households accessing enrolled water points', 'Between July 5, 2015, and Nov 11, 2015, 100 water points with 920 eligible households were enrolled into the study and randomly assigned to the treatment (50 water points; 517 children at baseline; 2073 child observations included in the primary analysis) or control groups (50; 519; 2154', '100 shared water points (clusters) in two low-income urban communities in Bangladesh', 'child diarrhoea prevalence in low-income, densely populated communities in urban Bangladesh', 'child diarrhoea in urban Bangladesh']","['line drinking water chlorination', 'installing novel passive chlorination devices', 'drinking water automatically chlorinated at the point of collection by a solid tablet chlorine doser (intervention group) or to be treated by a visually identical doser that supplied vitamin C (active control group']","['risk of diarrhoea', 'caregiver-reported child diarrhoea (≥3 loose or watery stools', 'WHO-defined diarrhoea']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C0175961', 'cui_str': 'Chlorination'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0008209', 'cui_str': 'Chlorine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205407', 'cui_str': 'Loose (qualifier value)'}, {'cui': 'C2129214', 'cui_str': 'Loose stool (finding)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}]",517.0,0.190009,"Children in the treatment group had less WHO-defined diarrhoea than did children in the control group (control 216 [10·0%] of 2154; treatment 156 [7·5%] of 2073; prevalence ratio 0·77, 95% CI 0·65-0·91).","[{'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Pickering', 'Affiliation': 'Civil and Environmental Engineering, Tufts University, Medford, MA, USA; Civil and Environmental Engineering, Stanford University, Stanford, CA, USA. Electronic address: amy.pickering@tufts.edu.'}, {'ForeName': 'Yoshika', 'Initials': 'Y', 'LastName': 'Crider', 'Affiliation': 'Civil and Environmental Engineering, Stanford University, Stanford, CA, USA; Energy and Resources Group, University of California Berkeley, Berkeley, CA, USA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Sultana', 'Affiliation': 'International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Swarthout', 'Affiliation': 'Civil and Environmental Engineering, Tufts University, Medford, MA, USA; Civil and Environmental Engineering, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Frederick Gb', 'Initials': 'FG', 'LastName': 'Goddard', 'Affiliation': 'Civil and Environmental Engineering, Stanford University, Stanford, CA, USA; Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Anjerul Islam', 'Affiliation': 'Civil and Environmental Engineering, Tufts University, Medford, MA, USA; International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Shreyan', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Civil and Environmental Engineering, Tufts University, Medford, MA, USA.'}, {'ForeName': 'Raga', 'Initials': 'R', 'LastName': 'Ayyagari', 'Affiliation': 'Civil and Environmental Engineering, Tufts University, Medford, MA, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Luby', 'Affiliation': 'Woods Institute for the Environment, Stanford University, Stanford, CA, USA.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30315-8']
1908,31402006,Effects of nutritional supplementation and home visiting on growth and development in young children in Madagascar: a cluster-randomised controlled trial.,"BACKGROUND


Evidence from efficacy trials suggests that lipid-based nutrient supplementation (LNS) and home visits can be effective approaches to preventing chronic malnutrition and promoting child development in low-income settings. We tested the integration of these approaches within an existing, large-scale, community-based nutrition programme in Madagascar.
METHODS


We randomly allocated 125 programme sites to five intervention groups: standard-of-care programme with monthly growth monitoring and nutrition education (T0); T0 plus home visits for intensive nutrition counselling through an added community worker (T1); T1 plus LNS for children aged 6-18 months (T2); T2 plus LNS for pregnant or lactating women (T3); or T1 plus fortnightly home visits to promote and encourage early stimulation (T4). Pregnant women (second or third trimester) and infants younger than 12 months were enrolled in the trial. Primary outcomes were child growth (length-for-age and weight-for-length Z scores) and development at age 18-30 months. Analyses were by intention to treat. The trial was registered with the ISRCTN registry, number ISRCTN14393738.
FINDINGS


The study enrolled 3738 mothers: 1248 pregnant women (250 women in each of the T0, T1, T2, and T4 intervention groups and 248 in the T3 intervention group) and 2490 children aged 0-11 months (497 children in T0, 500 in T1, 494 in T2, 499 in T3, and 500 in T4) at baseline who were assessed at 1-year and 2-year intervals. There were no main effects of any of the intervention groups on any measure of anthropometry or any of the child development outcomes in the full sample. However, compared with children in the T0 intervention group, the youngest children (<6 months at baseline) in the T2 and T3 intervention groups who were fully exposed to the child LNS dose had higher length-for-age Z scores (a significant effect of 0·210 SD [95% CI -0·004 to 0·424] for T2 and a borderline effect of 0·216 SD [0·043 to 0·389] for T3) and lower stunting prevalence (-9·0% [95% CI -16·7 to -1·2] for T2 and -8·2% [-15·6 to -0·7] for T3); supplementing mothers conferred no additional benefit.
INTERPRETATION


LNS for children for a duration of 12 months only benefited growth when it began at an early age, suggesting the need to supplement infants at age 6 months in a very low-income context. The lack of effect of the early stimulation messages and home visits might be due to little take-up of behaviour-change messages and delivery challenges facing community health workers.
FUNDING


Eunice Kennedy Shriver National Institutes of Child Health and Human Development, Strategic Impact Evaluation Fund, World Bank Innovation Grant, Early Learning Partnership Grant, World Bank Research Budget, Japan Nutrition Trust Fund, Power of Nutrition, and the National Nutrition Office of Madagascar.",2019,There were no main effects of any of the intervention groups on any measure of anthropometry or any of the child development outcomes in the full sample.,"['Pregnant women (second or third trimester) and infants younger than 12 months were enrolled in the trial', 'T3', 'young children in Madagascar', '3738 mothers: 1248 pregnant women (250 women in each of the T0, T1, T2, and T4 intervention groups and 248 in the T3 intervention group) and 2490 children aged 0-11 months (497 children in T0, 500 in T1, 494 in T2, 499 in T3, and 500 in T4) at baseline who were assessed at 1-year and 2-year intervals']","['standard-of-care programme with monthly growth monitoring and nutrition education (T0); T0 plus home visits for intensive nutrition counselling through an added community worker (T1); T1 plus LNS for children aged 6-18 months (T2); T2 plus LNS for pregnant or lactating women (T3); or T1 plus fortnightly home visits to promote and encourage early stimulation (T4', 'lipid-based nutrient supplementation (LNS', 'nutritional supplementation and home visiting']","['child growth (length-for-age and weight-for-length Z scores', 'stunting prevalence', 'higher length-for-age Z scores']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0032981', 'cui_str': 'Last Trimester'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0024443', 'cui_str': 'Malagasy Republic'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C3714365', 'cui_str': 'Counseling about nutrition'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",497.0,0.20103,There were no main effects of any of the intervention groups on any measure of anthropometry or any of the child development outcomes in the full sample.,"[{'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Galasso', 'Affiliation': 'Development Research Group, The World Bank, Washington, DC, USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Weber', 'Affiliation': 'School of Community Health Sciences, University of Nevada, Reno, NV, USA.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Stewart', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Lisy', 'Initials': 'L', 'LastName': 'Ratsifandrihamanana', 'Affiliation': 'Centre Médico-Educatif ""Les Orchidées Blanches"", Antananarivo, Madagascar.'}, {'ForeName': 'Lia C H', 'Initials': 'LCH', 'LastName': 'Fernald', 'Affiliation': 'School of Public Health, University of California Berkeley, Berkeley, CA, USA. Electronic address: fernald@berkeley.edu.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30317-1']
1909,32101614,"Evolution of cellular HIV DNA levels in virologically suppressed patients switching to dolutegravir/lamivudine versus maintaining a triple regimen: a prospective, longitudinal, matched, controlled study.","OBJECTIVES


To assess the impact of switching to dolutegravir plus lamivudine maintenance therapy on the HIV cellular reservoir size.
PATIENTS AND METHODS


This was a prospective, longitudinal, matched, controlled study. We enrolled virologically suppressed patients on stable three-drug ART who switched at baseline (BL) to dolutegravir/lamivudine (DT group) or maintained triple therapy (TT group); subjects in the TT group were matched 1:1 with those in the DT group according to age, gender, years since HIV diagnosis, years on ART and anchor drug. Total blood-associated HIV DNA levels were assessed by droplet digital PCR at BL and after 48 weeks (T48). Results were expressed as log10 HIV DNA copies/106 leucocytes.
RESULTS


We enrolled 40 patients in the DT group and 40 in the TT group; the two groups were homogeneous for all main characteristics except nadir CD4 cell count. At BL, HIV DNA levels were comparable between the DT and TT groups: 2.27 (IQR 1.97-2.47) and 2.26 (IQR 2.05-2.61) log10 HIV DNA copies/106 leucocytes, respectively. Change in HIV DNA load from BL to T48 was -0.105 (IQR -0.384 to 0.121, P = 0.041) in the DT group and -0.132 (IQR -0.362 to 0.046, P = 0.005) in the TT group, with a comparable decline observed between the two groups (P = 0.821). A higher HIV DNA decline was associated with higher BL CD4/CD8 ratio.
CONCLUSIONS


Maintenance therapy with dolutegravir/lamivudine had the same impact as the triple regimen on HIV DNA levels after 48 weeks of treatment. These data seem to support the effectiveness of a dolutegravir/lamivudine dual regimen in controlling the magnitude of the cellular reservoir (www.clinicaltrials.gov, number NCT02836782).",2020,Change in HIV DNA load from BL to T48 was -0.105,"['virologically suppressed patients switching to dolutegravir', 'TT group); subjects in the TT group were matched 1:1 with those in the DT group according to age, gender, years since HIV diagnosis, years on ART and anchor drug', 'enrolled virologically suppressed patients on stable three-drug ART who switched at baseline (BL) to']","['lamivudine', 'dolutegravir/lamivudine (DT group) or maintained triple therapy', 'dolutegravir/lamivudine', 'dolutegravir plus lamivudine maintenance therapy']","['Total blood-associated HIV DNA levels', 'HIV DNA levels', 'At BL, HIV DNA levels', 'nadir CD4 cell count']","[{'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]","[{'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}]",40.0,0.055901,Change in HIV DNA load from BL to T48 was -0.105,"[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Lombardi', 'Affiliation': 'Università Cattolica del Sacro Cuore, Dipartimento di Sicurezza e Bioetica Sezione Malattie Infettive, Rome, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Belmonti', 'Affiliation': 'Università Cattolica del Sacro Cuore, Dipartimento di Sicurezza e Bioetica Sezione Malattie Infettive, Rome, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Borghetti', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Malattie Infettive, Rome, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Fabbiani', 'Affiliation': 'Infectious and Tropical Diseases Unit, Azienda Ospedaliero-Universitaria Senese, Siena, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Marchetti', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Institute of Microbiology and Virology, Rome, Italy.'}, {'ForeName': 'Enrica', 'Initials': 'E', 'LastName': 'Tamburrini', 'Affiliation': 'Università Cattolica del Sacro Cuore, Dipartimento di Sicurezza e Bioetica Sezione Malattie Infettive, Rome, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cauda', 'Affiliation': 'Università Cattolica del Sacro Cuore, Dipartimento di Sicurezza e Bioetica Sezione Malattie Infettive, Rome, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'di Giambenedetto', 'Affiliation': 'Università Cattolica del Sacro Cuore, Dipartimento di Sicurezza e Bioetica Sezione Malattie Infettive, Rome, Italy.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa058']
1910,31342893,Effectiveness of school-home intervention for adolescent obesity prevention: parallel school randomised study.,"Many school-based interventions for obesity prevention have been proposed with positive changes in behaviour, but with unsatisfactory results on weight change. The objective was to verify the effectiveness of a combined school- and home-based obesity prevention programme on excessive weight gain in adolescents. Teachers delivered the school-based primary prevention programme to fifth- and sixth-graders (nine schools, forty-eight control classes, forty-nine intervention classes), which included encouraging healthy eating habits and physical activity. A subgroup of overweight or obese adolescents also received a home-based secondary prevention programme delivered by community health professionals. Schools were randomised to intervention or control group. Intent-to-treat analysis used mixed models for repeated continuous measures and considered the cluster effect. The main outcomes were changes in BMI and percentage body fat (%body fat) after one school-year of intervention and follow-up. Against our hypothesis, BMI increased more in the intervention group than in the control group (Δ = 0·3 kg/m2; P = 0·05) with a greater decrease in %body fat among boys (Δ = -0·6 %; P = 0·03) in the control group. The intervention group increased physical activity by 12·5 min per week compared with the control group. Female adolescents in the intervention group ate healthier items more frequently than in the control group. The subgroup that received both the school and home interventions had an increase in %body fat than in the control group (Δ = 0·89 %; P = 0·01). In the present study, a behavioural change led to a small increase in physical activity and healthy eating habits but also to an overall increase in food intake.",2019,The subgroup who received both the school and home interventions had an increase in %body fat than in the control group (Δ=0.89%; p=0.01).,"['adolescents', 'A subgroup of overweight or obese adolescents', 'adolescent obesity prevention', 'Female adolescents']","['home-based secondary prevention program delivered by community health professionals', 'school-home intervention', 'combined school and home-based obesity prevention program']","['BMI', 'excessive weight gain', 'body mass index (BMI) and percent body fat (%body fat', 'physical activity and healthy eating habits', 'physical activity', 'body fat']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4317171', 'cui_str': 'Adolescent Obesity'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0679699', 'cui_str': 'Disease Prevention, Secondary'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0000765', 'cui_str': 'Excessive weight gain (finding)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",,0.0254223,The subgroup who received both the school and home interventions had an increase in %body fat than in the control group (Δ=0.89%; p=0.01).,"[{'ForeName': 'Michele R', 'Initials': 'MR', 'LastName': 'Sgambato', 'Affiliation': 'Department of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro 20550-900, Brazil.'}, {'ForeName': 'Diana B', 'Initials': 'DB', 'LastName': 'Cunha', 'Affiliation': 'Department of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro 20550-900, Brazil.'}, {'ForeName': 'Bárbara S N', 'Initials': 'BSN', 'LastName': 'Souza', 'Affiliation': 'Department of Epidemiology, Fluminense Federal University, Rio de Janeiro 24030-210, Brazil.'}, {'ForeName': 'Viviana T', 'Initials': 'VT', 'LastName': 'Henriques', 'Affiliation': 'Department of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro 20550-900, Brazil.'}, {'ForeName': 'Renata R M', 'Initials': 'RRM', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro 20550-900, Brazil.'}, {'ForeName': 'Ana L V', 'Initials': 'ALV', 'LastName': 'Rêgo', 'Affiliation': 'Department of Social and Applied Nutrition, Federal University of Rio de Janeiro, Rio de Janeiro 21941-590, Brazil.'}, {'ForeName': 'Rosangela A', 'Initials': 'RA', 'LastName': 'Pereira', 'Affiliation': 'Department of Social and Applied Nutrition, Federal University of Rio de Janeiro, Rio de Janeiro 21941-590, Brazil.'}, {'ForeName': 'Edna M', 'Initials': 'EM', 'LastName': 'Yokoo', 'Affiliation': 'Department of Epidemiology, Fluminense Federal University, Rio de Janeiro 24030-210, Brazil.'}, {'ForeName': 'Rosely', 'Initials': 'R', 'LastName': 'Sichieri', 'Affiliation': 'Department of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro 20550-900, Brazil.'}]",The British journal of nutrition,['10.1017/S0007114519001818']
1911,32088934,Application of a social media platform as a patient reminder in the treatment of Helicobacter pylori.,"BACKGROUND


To investigate the effect of a social media platform for the treatment of Helicobacter pylori infection.
MATERIALS AND METHODS


We enrolled 222 patients from October 2018 to June 2019, who required H pylori therapy. We used WeChat, a social media platform, as a patient reminder tool. They were randomly divided into the intervention and control groups (n = 111 per group) to compare and evaluate their disease awareness, medication adherence, incidence of adverse drug reactions, and H pylori eradication rate.
RESULTS


Patients in the intervention group had significantly better disease-related knowledge, medication adherence, and H pylori eradication rates than those in the control group (P < .05).
CONCLUSIONS


Using a social media platform may improve treatment rates of H pylori infection.",2020,"RESULTS


Patients in the intervention group had significantly better disease-related knowledge, medication adherence, and H pylori eradication rates than those in the control group (P < .05).
","['We enrolled 222 patients from October 2018 to June 2019, who required H\xa0pylori therapy', 'Helicobacter pylori']",['social media platform'],"['disease-related knowledge, medication adherence, and H\xa0pylori eradication rates', 'disease awareness, medication adherence, incidence of adverse drug reactions, and H\xa0pylori eradication rate', 'treatment rates of H\xa0pylori infection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]","[{'cui': 'C3179065', 'cui_str': 'Social Media'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",222.0,0.0213189,"RESULTS


Patients in the intervention group had significantly better disease-related knowledge, medication adherence, and H pylori eradication rates than those in the control group (P < .05).
","[{'ForeName': 'Miaomiao', 'Initials': 'M', 'LastName': 'Luo', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital, Shihezi University School of Medicine, Xinjiang, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hao', 'Affiliation': 'Department of Urology, The First Affiliated Hospital, Shihezi University School of Medicine, Xinjiang, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Tang', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital, Shihezi University School of Medicine, Xinjiang, China.'}, {'ForeName': 'Mengzhen', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital, Shihezi University School of Medicine, Xinjiang, China.'}, {'ForeName': 'Fengjuan', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital, Shihezi University School of Medicine, Xinjiang, China.'}, {'ForeName': 'Yuanmao', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital, Shihezi University School of Medicine, Xinjiang, China.'}, {'ForeName': 'Weigang', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital, Shihezi University School of Medicine, Xinjiang, China.'}]",Helicobacter,['10.1111/hel.12682']
1912,32109313,The efficacy of ketamine for postoperative pain control in adolescent patients undergoing spinal fusion surgery for idiopathic scoliosis.,"The use of ketamine in conjunction with morphine to reduce postoperative pain has been explored in several different surgery subtypes with conflicting results. Ketamine has shown promise to have both opioid sparing and analgesic effects in the postoperative setting. This study aimed to elucidate ketamine's ability to reduce morphine equivalent consumption and improve patient satisfaction after spinal fusion surgery for the correction of idiopathic scoliosis. This surgery is known to be associated with significant postoperative pain which impedes the ability to improve patient satisfaction, and may complicate the recovery timeline. Currently, the standard therapeutic regimen consists of patient-controlled analgesia morphine and the use of other opioids such as hydromorphone. A prospective, randomized double-blinded, placebo-controlled trial was performed to compare the standard morphine equivalent therapy alone against a standard therapy in conjunction with ketamine. Fifty adolescent patients were enrolled and randomized. Results yielded a significant reduction in postoperative morphine equivalent consumption (p = 0.042), adjusted postoperative pain scores (p < 0.001), and incidence of nausea and vomiting (p = 0.045). The application of ketamine as an analgesic in conjunction with the current standard of morphine equivalent therapy may serve as a superior pain control regimen for spinal surgeries in young population. This regimen enhancement may be generalizable to other surgery subtypes within similar populations. LEVEL OF EVIDENCE: Level I.",2020,"Results yielded a significant reduction in postoperative morphine equivalent consumption (p = 0.042), adjusted postoperative pain scores (p < 0.001), and incidence of nausea and vomiting (p = 0.045).","['Fifty adolescent patients', 'spinal surgeries in young population', 'idiopathic scoliosis', 'adolescent patients undergoing spinal fusion surgery for idiopathic scoliosis']","['Ketamine', 'placebo', 'ketamine', 'hydromorphone', 'morphine']","['postoperative morphine equivalent consumption', 'nausea and vomiting', 'patient satisfaction', 'adjusted postoperative pain scores']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0595995', 'cui_str': 'Idiopathic scoliosis (disorder)'}, {'cui': 'C0919636', 'cui_str': 'Operative spinal fusion'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",50.0,0.218573,"Results yielded a significant reduction in postoperative morphine equivalent consumption (p = 0.042), adjusted postoperative pain scores (p < 0.001), and incidence of nausea and vomiting (p = 0.045).","[{'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Ricciardelli', 'Affiliation': 'Albany Medical College, Albany Medical Center, Albany, NY, USA.'}, {'ForeName': 'Noah M', 'Initials': 'NM', 'LastName': 'Walters', 'Affiliation': 'Albany Medical College, Albany Medical Center, Albany, NY, USA.'}, {'ForeName': 'Maxwill', 'Initials': 'M', 'LastName': 'Pomerantz', 'Affiliation': 'Albany Medical College, Albany Medical Center, Albany, NY, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Metcalfe', 'Affiliation': 'Department of Anesthesiology, University of Michigan Hospitals and Health Centers, Ann Arbor, USA.'}, {'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Afroze', 'Affiliation': 'Department of Anesthesiology, Albany Medical Center, Albany, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Ehlers', 'Affiliation': 'Department of Anesthesiology, Albany Medical Center, Albany, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Leduc', 'Affiliation': 'Department of Anesthesiology, GHS Greenville Memorial Hospital, Greenville, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Feustel', 'Affiliation': 'Albany Medical College, Albany Medical Center, Albany, NY, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Silverman', 'Affiliation': 'Department of Anesthesiology, Albany Medical Center, Albany, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Carl', 'Affiliation': 'Department of Orthopedic Surgery, Albany Medical Center, Albany, USA. alcsar308@gmail.com.'}]",Spine deformity,['10.1007/s43390-020-00073-w']
1913,32109005,A well-tolerated new amino acid-based formula for cow's milk allergy.,"OBJECTIVES


Infants with cow's milk allergy (CMA) are in need of a substitute formula up to 2 years. The are three requisites for a substitute of milk in CMA: tolerability, nutritional adequacy, and cost-effectiveness. We evaluate here the tolerability of a new amino acid-based infant formula for the management of CMA.
METHODS


In a phase III/IV prospective, multicentre, open-label, international study, infants and children with immunoglobulin E-mediated CMA were exposed to a diagnostic double-blinded, placebo-controlled food challenge with a new amino acid formula by Blemil Plus Elemental using Neocate as the placebo. If tolerant to it, the study formula was integrated into the patients' usual daily diet for 7 days. Efficacy on day 7 was assessed in terms of symptoms associated with CMA, amount of formula consumed, nutritional and energy intake, and anthropometric data.
RESULTS


Thirty children (17 M and 13 F; median age, 1.58; range, 0.08-12.83 years) completed the open challenge and were able to consume the study formula for at least 7 days. No signs or symptoms of allergic reactions were recorded among children assuming either the test or the control formula, with a lower 95% one-sided confidence interval for the proportion of subjects who did not experience allergic reactions above 90%. Sixteen patient under the age of two continued with the optional extension phase.
CONCLUSIONS


The study formula meets the American Academy of Pediatric criteria for hypoallergenicity and is well tolerated in short-term use. During optional phase, growth of the patients was not hindered by the study formula.",2020,"No signs or symptoms of allergic reactions were recorded among children assuming either the test or the control formula, with a lower 95% one-sided confidence interval for the proportion of subjects who did not experience allergic reactions above 90%.","['infants and children with immunoglobulin E-mediated CMA', 'Thirty children (17 M and 13 F; median age, 1.58; range, 0.08-12.83 years', 'Sixteen patient under the age of two continued with the optional extension phase', ""Infants with cow's milk allergy (CMA""]","['placebo-controlled food challenge with a new amino acid formula by Blemil Plus Elemental using Neocate as the placebo', 'new amino acid-based infant formula']","['symptoms associated with CMA, amount of formula consumed, nutritional and energy intake, and anthropometric data', 'signs or symptoms of allergic reactions']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517417', 'cui_str': 'Zero point zero eight'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0266815', 'cui_str': ""Cow's milk protein sensitivity (disorder)""}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0379545', 'cui_str': 'Neocate'}, {'cui': 'C4074817', 'cui_str': 'Amino acid-based infant formula (finding)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C1527304', 'cui_str': 'Allergic Reaction'}]",30.0,0.0326434,"No signs or symptoms of allergic reactions were recorded among children assuming either the test or the control formula, with a lower 95% one-sided confidence interval for the proportion of subjects who did not experience allergic reactions above 90%.","[{'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Fierro', 'Affiliation': 'Pediatric Allergy Unit, Bambino Gesù Hospital, Roma, Italy.'}, {'ForeName': 'Rocco L', 'Initials': 'RL', 'LastName': 'Valluzzi', 'Affiliation': 'Pediatric Allergy Unit, Bambino Gesù Hospital, Roma, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Banzato', 'Affiliation': 'Azienda Ospedaliera Universitaria Integrata, Verona, Italy.'}, {'ForeName': 'Ma A', 'Initials': 'MA', 'LastName': 'Plaza', 'Affiliation': 'Hospital Sant Joan de Deu, Barcelona, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Bosque', 'Affiliation': 'Consorci Sanitari Parc Taulí, Sabadell, Spain.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Íbero', 'Affiliation': 'Hospital de Terrassa, Terrassa, Spain.'}, {'ForeName': 'Luis A Z', 'Initials': 'LAZ', 'LastName': 'Echeverría', 'Affiliation': 'Hospital Severo Ochoa, Laganès, Spain.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Mennini', 'Affiliation': 'Pediatric Allergy Unit, Bambino Gesù Hospital, Roma, Italy.'}, {'ForeName': 'Lamia', 'Initials': 'L', 'LastName': 'Dahdah', 'Affiliation': 'Pediatric Allergy Unit, Bambino Gesù Hospital, Roma, Italy.'}, {'ForeName': 'Roser', 'Initials': 'R', 'LastName': 'de Castellar', 'Affiliation': 'Laboratorios Ordesa, Sant Boi de Llobregat, Spain.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Tort', 'Affiliation': 'Laboratorios Ordesa, Sant Boi de Llobregat, Spain.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Jiménez', 'Affiliation': 'Laboratorios Ordesa, Sant Boi de Llobregat, Spain.'}]","Immunity, inflammation and disease",['10.1002/iid3.286']
1914,31400513,Targeting pregnancy-related weight gain to reduce disparities in obesity: Baseline results from the Healthy Babies trial.,"BACKGROUND


Obesity affects African American women more than any other group in the US. Pregnancy represents a critical life stage of heightened vulnerability for new or persistent obesity, yet few interventions have been effective in reducing excessive gestational weight gain among African American women. We describe the design and baseline findings of Healthy Babies, a two-arm randomized controlled trial testing a mobile health intervention to minimize excessive gestational weight gain versus usual care in this high risk group.
METHODS


African American women in early pregnancy were recruited from two large obstetric practices as well as Philadelphia Women, Infants, and Children's clinics. Participants randomized to the intervention received behavior change goals, daily text messages with feedback, web-based weight gain graphs, health coaching, and a Facebook support group. Data collection included baseline (<22 weeks' gestation), 36-38 weeks' gestation, and 6-month postpartum anthropometric measures and assessments of demographics, contextual factors and behavioral targets. The primary outcome was prevalence of excessive gestational weight gain.
RESULTS


Among participants at baseline (n = 262), the majority met criteria for obesity (63%), were multiparous (62%), single (77%), and were on average 25.6 ± 5.4 years old with a gestational age of 13.9 ± 4.1 weeks. While 82% completed high school, 61% met criteria for inadequate health literacy. Nearly 20% were food insecure. Eighty-eight percent reported a gestational weight gain goal discordant with Institute of Medicine guidelines. There were no significant differences in baseline characteristics between study arms.
CONCLUSIONS


Participants represent a high-risk group for excessive gestational weight gain with demonstrated need for intervention.",2019,"There were no significant differences in baseline characteristics between study arms.
","['African American women', 'Healthy Babies trial', ""African American women in early pregnancy were recruited from two large obstetric practices as well as Philadelphia Women, Infants, and Children's clinics"", 'Healthy Babies', 'Eighty-eight percent reported a gestational weight gain goal discordant with Institute of Medicine guidelines', 'participants at baseline (n\u202f=\u202f262), the majority met criteria for obesity (63%), were multiparous (62%), single (77%), and were on average 25.6\u202f±\u202f5.4\u202fyears old with a gestational age of 13.9\u202f±\u202f4.1\u202fweeks']","['mobile health intervention to minimize excessive gestational weight gain versus usual care', 'behavior change goals, daily text messages with feedback, web-based weight gain graphs, health coaching, and a Facebook support group']","['6-month postpartum anthropometric measures and assessments of demographics, contextual factors and behavioral targets', 'excessive gestational weight gain', 'prevalence of excessive gestational weight gain']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0021621', 'cui_str': 'National Academies of Science, Engineering, and Medicine (US) Health and Medicine Division'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0026751', 'cui_str': 'Multiparity'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C4517562', 'cui_str': '13.9 (qualifier value)'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",,0.278138,"There were no significant differences in baseline characteristics between study arms.
","[{'ForeName': 'Sharon J', 'Initials': 'SJ', 'LastName': 'Herring', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America; Department of Obstetrics, Gynecology, and Reproductive Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America; Department of Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America. Electronic address: herris01@temple.edu.'}, {'ForeName': 'Jessica J', 'Initials': 'JJ', 'LastName': 'Albert', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Niesha', 'Initials': 'N', 'LastName': 'Darden', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Bailer', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Center for Weight and Eating Disorders, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Cruice', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Sarmina', 'Initials': 'S', 'LastName': 'Hassan', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Gary G', 'Initials': 'GG', 'LastName': 'Bennett', 'Affiliation': 'Department of Psychology and Neuroscience, Duke University, Durham, NC, United States of America; Duke Digital Health Science Center, Duke Global Health Institute, Durham, NC, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Goetzl', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, University of Texas Health Center at Houston, Houston, TX, United States of America.'}, {'ForeName': 'Daohai', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Kilby', 'Affiliation': 'Philadelphia Women, Infants and Children Program, Philadelphia, PA, United States of America.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Foster', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Center for Weight and Eating Disorders, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America; Weight Watchers International, New York, NY, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105822']
1915,31164265,Adjuvant zoledronic acid and letrozole plus ovarian function suppression in premenopausal breast cancer: HOBOE phase 3 randomised trial.,"AIM


The aim of the study is to analyse whether letrozole (L) and zoledronic acid plus L (ZL) are more effective than tamoxifen (T) as adjuvant endocrine treatment of premenopausal patients with breast cancer with hormone receptor-positive (HR+) tumours.
PATIENTS AND METHODS


In a phase 3 trial, 1065 premenopausal patients with HR + early breast cancer received triptorelin to suppress ovarian function and were randomly assigned (1:1:1) to adjuvant T, L or ZL for 5 years. Cancer recurrence, second breast or non-breast cancer and death were considered events for the intention-to-treat disease-free survival (DFS) analysis.
RESULTS


With a 64-month median follow-up and 134 reported events, the disease-free rate at 5 years was 85.4%, 93.2% and 93.3% with T, L and ZL, respectively (overall P = 0.008). The hazard ratio for a DFS event was 0.52 (95% confidence interval [CI], 0.34 to 0.80; P = 0.003) with ZL vs T, 0.72 (95% CI, 0.48 to 1.07; P = 0.06) with L vs T and 0.70 (95% CI, 0.44 to 1.12; P = 0.22) with ZL vs L. With 36 deaths, there was no significant difference in overall survival (P = 0.14). Treatment was stopped for toxicity or refusal in 7.3%, 7.3% and 16.6% patients, and in the safety population, grade 3-4 side-effects were reported in 4.2%, 6.9% and 9.1% patients treated with T, L or ZL, respectively.
CONCLUSION


HOBOE study shows that in premenopausal patients with early breast cancer undergoing ovarian function suppression with triptorelin, ZL significantly improves DFS, while worsening compliance and toxicity, as compared with T. (NCT00412022).",2019,"The hazard ratio for a DFS event was 0.52 (95% confidence interval [CI], 0.34 to 0.80; P = 0.003) with ZL vs T, 0.72 (95% CI, 0.48 to 1.07; P = 0.06) with L vs T and 0.70","['premenopausal patients with early breast cancer undergoing ovarian function suppression with', '1065 premenopausal patients with HR\xa0+\xa0early breast cancer received', 'premenopausal breast cancer', 'premenopausal patients with breast cancer with hormone receptor-positive (HR+) tumours']","['tamoxifen (T', 'triptorelin, ZL', 'letrozole (L) and zoledronic acid plus L (ZL', 'Adjuvant zoledronic acid and letrozole plus ovarian function suppression', 'ZL', 'triptorelin', 'adjuvant T, L or ZL']","['DFS', 'hazard ratio for a DFS event', 'Cancer recurrence, second breast or non-breast cancer and death', 'disease-free rate', 'toxicity or refusal', 'worsening compliance and toxicity', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0741682', 'cui_str': 'Premenopausal breast cancer'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0077275', 'cui_str': 'Triptorelin'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",1065.0,0.139029,"The hazard ratio for a DFS event was 0.52 (95% confidence interval [CI], 0.34 to 0.80; P = 0.003) with ZL vs T, 0.72 (95% CI, 0.48 to 1.07; P = 0.06) with L vs T and 0.70","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Perrone', 'Affiliation': 'Clinical Trial Unit, Istituto Nazionale Tumori, IRCCS, Fondazione G.Pascale, Napoli, Italy. Electronic address: f.perrone@istitutotumori.na.it.'}, {'ForeName': 'Michelino', 'Initials': 'M', 'LastName': 'De Laurentiis', 'Affiliation': 'Clinical and Experimental Senology, Istituto Nazionale Tumori, IRCCS, Fondazione G.Pascale, Napoli, Italy.'}, {'ForeName': 'Sabino', 'Initials': 'S', 'LastName': 'De Placido', 'Affiliation': 'Department of Medical and Surgical Clinics, Università Federico II, Napoli, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Orditura', 'Affiliation': 'Oncoematology Unit, Università Degli Studi Della Campania ""Luigi Vanvitelli"", Napoli, Italy.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Cinieri', 'Affiliation': 'Oncology, Ospedale A.Perrino, Brindisi, Italy.'}, {'ForeName': 'Ferdinando', 'Initials': 'F', 'LastName': 'Riccardi', 'Affiliation': 'Medical Oncology, Ospedale Cardarelli, Napoli, Italy.'}, {'ForeName': 'Angela Stefania', 'Initials': 'AS', 'LastName': 'Ribecco', 'Affiliation': 'Oncology, Ospedale S.Maria Annunziata Bagno a Ripoli, Firenze, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Putzu', 'Affiliation': 'Medical Oncology, Azienda Ospedaliera Universitaria, Sassari, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Del Mastro', 'Affiliation': 'IRCCS Ospedale Policlinico San Martino, Genova, Italy; Department of Internal Medicine (DIMI), Università di Genova, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Rossi', 'Affiliation': 'Medical Oncology, A.O. San Giuseppe Moscati, Avellino, Italy.'}, {'ForeName': 'Vincenza', 'Initials': 'V', 'LastName': 'Tinessa', 'Affiliation': 'Medical Oncology, Ospedale Rummo, Benevento, Italy.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Mosconi', 'Affiliation': 'Medical Oncology, Ospedale Santa Maria Della Misericordia, S.Andrea Delle Fratte, Perugia, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Nuzzo', 'Affiliation': 'Clinical and Experimental Senology, Istituto Nazionale Tumori, IRCCS, Fondazione G.Pascale, Napoli, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Di Rella', 'Affiliation': 'Clinical and Experimental Senology, Istituto Nazionale Tumori, IRCCS, Fondazione G.Pascale, Napoli, Italy.'}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Gravina', 'Affiliation': 'Clinical and Experimental Senology, Istituto Nazionale Tumori, IRCCS, Fondazione G.Pascale, Napoli, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Iodice', 'Affiliation': 'Clinical and Experimental Senology, Istituto Nazionale Tumori, IRCCS, Fondazione G.Pascale, Napoli, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Landi', 'Affiliation': 'Clinical and Experimental Senology, Istituto Nazionale Tumori, IRCCS, Fondazione G.Pascale, Napoli, Italy.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Pacilio', 'Affiliation': 'Clinical and Experimental Senology, Istituto Nazionale Tumori, IRCCS, Fondazione G.Pascale, Napoli, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Forestieri', 'Affiliation': 'Department of Medical and Surgical Clinics, Università Federico II, Napoli, Italy.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Lauria', 'Affiliation': 'Department of Medical and Surgical Clinics, Università Federico II, Napoli, Italy.'}, {'ForeName': 'Agnese', 'Initials': 'A', 'LastName': 'Fabbri', 'Affiliation': 'Department of Medical Oncology, Ospedale Belcolle, Viterbo, Italy.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Ibrahim', 'Affiliation': 'Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola FC, Italy.'}, {'ForeName': 'Ermelinda', 'Initials': 'E', 'LastName': 'De Maio', 'Affiliation': 'Oncology, Azienda Usl Toscana Nord Ovest, Livorno, Italy.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Barni', 'Affiliation': 'Medical Oncology - Ospedale di Treviglio Caravaggio BG, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Gori', 'Affiliation': 'Medical Oncology, IRCCS, Ospedale Sacro Cuore Don Calabria, Negrar VR, Italy.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Simeon', 'Affiliation': 'Medical Statistics, Università Degli Studi Della Campania ""Luigi Vanvitelli"", Napoli, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Arenare', 'Affiliation': 'Clinical Trial Unit, Istituto Nazionale Tumori, IRCCS, Fondazione G.Pascale, Napoli, Italy.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Daniele', 'Affiliation': 'Clinical Trial Unit, Istituto Nazionale Tumori, IRCCS, Fondazione G.Pascale, Napoli, Italy.'}, {'ForeName': 'Maria Carmela', 'Initials': 'MC', 'LastName': 'Piccirillo', 'Affiliation': 'Clinical Trial Unit, Istituto Nazionale Tumori, IRCCS, Fondazione G.Pascale, Napoli, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Normanno', 'Affiliation': 'Cellular Biology and Biotherapies, Istituto Nazionale Tumori, IRCCS, Fondazione G.Pascale, Napoli, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'de Matteis', 'Affiliation': 'Clinical and Experimental Senology, Istituto Nazionale Tumori, IRCCS, Fondazione G.Pascale, Napoli, Italy.'}, {'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Gallo', 'Affiliation': 'Medical Statistics, Università Degli Studi Della Campania ""Luigi Vanvitelli"", Napoli, Italy.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.05.004']
1916,32109133,"Hab-o Shefa, a Persian Medicine Compound for Maintenance Treatment of Opioid Dependence: Randomized Placebo-Controlled Clinical Trial.","Objectives:  The major problem in maintenance treatment of opioid use disorder is craving and relapse. The utilization of herbal compounds and complementary therapy for treatment of disease and addiction has been widely expanding. Considering the significant effect of Hab-o Shefa in detoxification phase, this clinical trial has explored the influence of this compound on maintenance treatment of opioid-dependent patients. This product is made of four herbs, including  Datura stramonium  L.,  Rheum palmatum  L.,  Zingiber officinale  Roscoe, and  Acacia senegal  L.  Design:  The authors conducted a two-group parallel randomized double-blind clinical trial on 81 opioid-dependent patients within 12 weeks. After medically assisted detoxification, participants were assigned randomly to Hab-o Shefa ( n  = 41) and placebo ( n  = 40). Outcome measures included craving assessed by craving beliefs questionnaire, self-reported opioid use, and lapse (any opioid-positive urine test) according to urinalysis and addiction severity index-lite questionnaire, retention in treatment, and depression and anxiety scores on the Hamilton's anxiety and depression scales.  Results:  Forty-one participants completed the study for 12 weeks, 21 subjects in the drug group and 20 subjects in the placebo group. The rates of opioid-positive urine tests and self-reported opioid use were significantly lower in Hab-o Shefa group ( f  = 8.41,  p  = 0.001). Hab-o Shefa also indicated a significant superiority over placebo in the effect of treatment by time interaction for craving ( f  = 5.91,  p  = 0.001), depression ( f  = 3.40,  p  = 0.01), and anxiety ( f  = 2.58,  p  = 0.035). The retention time was 66.6 days for drug group and 59.6 days for placebo one. Although the causes for dropping out in two groups were different, there was no significant difference ( p  = 0.623). The side effects of the two groups were not significantly different.  Conclusion:  Results indicated that Hab-o Shefa could be useful for opioid maintenance treatment, and it can also be considered as a new promising drug for prevention of craving and relapse.",2020,"The rates of opioid-positive urine tests and self-reported opioid use were significantly lower in Hab-o Shefa group ( f  = 8.41,  p  = 0.001).","['81 opioid-dependent patients within 12 weeks', 'Forty-one participants completed the study for 12 weeks, 21 subjects in the drug group and 20 subjects in the placebo group']","['placebo', 'opioid use disorder', 'Placebo']","['retention time', 'side effects', 'anxiety', ""craving assessed by craving beliefs questionnaire, self-reported opioid use, and lapse (any opioid-positive urine test) according to urinalysis and addiction severity index-lite questionnaire, retention in treatment, and depression and anxiety scores on the Hamilton's anxiety and depression scales"", 'rates of opioid-positive urine tests and self-reported opioid use', 'depression']","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3540005', 'cui_str': 'URINE TESTS'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0450981', 'cui_str': 'Addiction severity index (assessment scale)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}]",81.0,0.169592,"The rates of opioid-positive urine tests and self-reported opioid use were significantly lower in Hab-o Shefa group ( f  = 8.41,  p  = 0.001).","[{'ForeName': 'Abdolali', 'Initials': 'A', 'LastName': 'Moosavyzadeh', 'Affiliation': 'Department of Iranian Traditional Medicine, Faculty of Medicine, Shahed University, Tehran, Iran.'}, {'ForeName': 'Azarakhsh', 'Initials': 'A', 'LastName': 'Mokri', 'Affiliation': 'Psychiatry Department and National Center for Addiction Studies, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Ghaffari', 'Affiliation': 'School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Soghrat', 'Initials': 'S', 'LastName': 'Faghihzadeh', 'Affiliation': 'Department of Biological statistics and Epidemiology, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Azizi', 'Affiliation': 'Department of Physiology, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Jafari Hajati', 'Affiliation': 'Traditional Medicine Clinical Trial Research Center, Shahed University, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Naseri', 'Affiliation': 'Traditional Medicine Clinical Trial Research Center, Shahed University, Tehran, Iran.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0390']
1917,31021357,APOE Genotype Influences Postprandial Blood Pressure after High Fat Feeding in Older Adults.,"OBJECTIVE


Postprandial hypotension (PPH) is a common phenomenon among older adults. The degree to which individuals experience PPH is related to cerebrovascular risk factors and the presence of neurodegenerative diseases such as Alzheimer's disease (AD). Carrier status of the E4 allele of the apolipoprotein E (APOE) gene is a risk factor for AD and influences a variety of responses to metabolic and dietary interventions. However, it is unknown whether APOE genotype influences the risk of PPH and whether type of meal can mediate that response.
DESIGN


Acute meal study with a crossover design.
PARTICIPANTS


32 cognitively healthy older adults with (n=18) and without (n=14) E4+ carrier status.
INTERVENTION


As a part of an ongoing meal study we examined the postprandial blood pressure response after ingestion of a high carbohydrate (HCM) and high fat meal (HFM).
MEASUREMENTS


Blood pressure measurements were taken at 7 time points and change scores, area under the curve (AUC) scores were calculated. Data were analyzed by repeated measures ANOVA as well as Pearson correlation.
RESULTS


Both meals produced a sustained drop in systolic (SBP) and diastolic (DBP) blood pressure, with 37.5% of participants meeting criteria for PPH. Participants carrying the E4+ risk gene experienced a larger decrease in SBP than E4- participants, and this was significantly different after the HFM (E4+ AUC = -30.8 ± 7.6, E4- AUC = -0.2 ± 8.7, p=0.015). Increasing age was associated with a larger drop in postprandial blood pressure but only for the E4+ group after the HFM (p=0.002).
CONCLUSIONS


These data suggest that E4+ individuals experience a greater postprandial blood pressure response particularly following high fat feeding, and this effect becomes more pronounced with age. The prevalence of PPH may play a role in the development of AD and may be mediated by diet.",2019,"Increasing age was associated with a larger drop in postprandial blood pressure but only for the E4+ group after the HFM (p=0.002).
","['32 cognitively healthy older adults with (n=18) and without (n=14) E4+ carrier status', 'Older Adults', 'older adults']","['high carbohydrate (HCM) and high fat meal (HFM', 'Postprandial hypotension (PPH']","['systolic (SBP) and diastolic (DBP) blood pressure', 'postprandial blood pressure response', 'SBP', 'postprandial blood pressure', 'Blood pressure measurements', 'change scores, area under the curve (AUC) scores']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0449439', 'cui_str': 'Carrier status (attribute)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response (observable entity)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",32.0,0.0261617,"Increasing age was associated with a larger drop in postprandial blood pressure but only for the E4+ group after the HFM (p=0.002).
","[{'ForeName': 'K C', 'Initials': 'KC', 'LastName': 'Stewart', 'Affiliation': 'Angela J Hanson, MD, Assistant Professor, Geriatric Medicine, University of Washington School of Medicine, 325 9th Ave, Box 359755, Seattle, WA, USA 98104, Phone: 206-897-5393, Fax: 206-744-9976, Email: hansonaj@uw.edu.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Subramanian', 'Affiliation': ''}, {'ForeName': 'U J', 'Initials': 'UJ', 'LastName': 'Neal', 'Affiliation': ''}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Hanson', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-019-1167-0']
1918,31989240,Acute and daily effects of repeated voluntary hyperpnea on pulmonary function in healthy adults.,"PURPOSE


Hyperpnea training has been used as a method for both improving exercise performance in healthy persons and improving ventilatory capacity in patients with pulmonary disease. However, voluntary hyperpnea causes acute declines in pulmonary function, but the effects of repeated days of hyperpnea on airway function are not known. The purpose of this study was to determine the effects of repeated normocapnic hyperpnea on daily and post-hyperpnea pulmonary function in healthy adults.
METHODS


Ten healthy adults (21 years; 170 cm; 66 kg) completed ten hyperpnea training sessions within 17-days (TR). Training sessions consisted of 20-minutes of normocapnic hyperpnea with gradually increased minute ventilation over the 10 days. Spirometry was assessed at baseline and serially following hyperpnea during each experimental day. A control group (24 years; 171 cm; 66 kg) completed 10 days of spirometry with no hyperpnea training (CON).
RESULTS


In both CON and TR subjects, baseline pulmonary function was unchanged during the 10 days. In TR subjects, pulmonary function was decreased at 5 mins after hyperpnea but thereafter increased to pre-hyperpnea values by 30 mins. Furthermore, these changes in pulmonary function were consistent during the 10 training days. In TR subjects, maximal voluntary ventilation decreased by 10.4 ± 8.9% (168-150 L min -1 ) over the 10 days (P < 0.05), whereas it was unchanged in CON subjects.
CONCLUSIONS


These findings demonstrate that voluntary hyperpnea acutely decreases airway function in healthy subjects. However, there does not appear to be a cumulative effect of repeated hyperpnea, as daily pulmonary function was unchanged.",2020,"In TR subjects, maximal voluntary ventilation decreased by 10.4 ± 8.9% (168-150 L min -1 ) over the 10 days (P < 0.05), whereas it was unchanged in CON subjects.
","['healthy adults', 'healthy persons', 'patients with pulmonary disease', 'healthy subjects', 'Ten healthy adults (21\xa0years; 170\xa0cm; 66\xa0kg) completed ten']","['repeated voluntary hyperpnea', 'repeated normocapnic hyperpnea', 'Hyperpnea training', 'spirometry with no hyperpnea training (CON', 'voluntary hyperpnea', 'hyperpnea training sessions within 17-days (TR']","['minute ventilation', 'maximal voluntary ventilation', 'exercise performance', 'pulmonary function', 'baseline pulmonary function', 'airway function']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0220854', 'cui_str': 'Hyperpnea (finding)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C1384388', 'cui_str': 'Maximum breathing capacity, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",10.0,0.0236597,"In TR subjects, maximal voluntary ventilation decreased by 10.4 ± 8.9% (168-150 L min -1 ) over the 10 days (P < 0.05), whereas it was unchanged in CON subjects.
","[{'ForeName': 'Eden', 'Initials': 'E', 'LastName': 'Towers', 'Affiliation': 'Department of Environmental and Health Sciences, Northern Vermont University-Johnson, 337 College Hill Road, Johnson, VT, 05405, USA.'}, {'ForeName': 'Adriane', 'Initials': 'A', 'LastName': 'Morrison-Taylor', 'Affiliation': 'Department of Environmental and Health Sciences, Northern Vermont University-Johnson, 337 College Hill Road, Johnson, VT, 05405, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Demar', 'Affiliation': 'Department of Environmental and Health Sciences, Northern Vermont University-Johnson, 337 College Hill Road, Johnson, VT, 05405, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Klansky', 'Affiliation': 'Department of Environmental and Health Sciences, Northern Vermont University-Johnson, 337 College Hill Road, Johnson, VT, 05405, USA.'}, {'ForeName': 'Kasie', 'Initials': 'K', 'LastName': 'Craig', 'Affiliation': 'Department of Environmental and Health Sciences, Northern Vermont University-Johnson, 337 College Hill Road, Johnson, VT, 05405, USA.'}, {'ForeName': 'Hans Christian', 'Initials': 'HC', 'LastName': 'Haverkamp', 'Affiliation': 'Department of Nutrition and Exercise Physiology, Elson S. Floyd College of Medicine, Washington State University, PO Box 1495, Spokane, WA, 99210-1495, USA. hans.haverkamp@wsu.edu.'}]",European journal of applied physiology,['10.1007/s00421-020-04302-y']
1919,32091102,Pharmacovirological analyses of blood and male genital compartment in patients receiving dolutegravir + lamivudine dual therapy as a switch strategy (ANRS 167 LAMIDOL trial).,"OBJECTIVES


To describe plasma residual HIV viraemia, cellular HIV reservoir size, blood plasma drug concentrations and their male genital tract penetration during the maintenance dual therapy dolutegravir + lamivudine.
PATIENTS AND METHODS


ANRS167 LAMIDOL enrolled 104 virologically suppressed patients to switch to dolutegravir + lamivudine. In this pharmacovirological substudy, ultrasensitive plasma viral load (USpVL) and plasma drug concentrations were measured at Day 0 (D0), Week 24 (W24) and W48 of dolutegravir + lamivudine, and HIV-DNA was measured at W-8 and W48. Semen samples were collected at D0 and W24 from 18 participants. Total and unbound blood and seminal plasma drug concentrations were measured using UPLC-MS/MS.
RESULTS


Median HIV-DNA was 2.5 log10 copies/106 PBMC (IQR = 2.2-3.0, n = 100) at W-8 and 2.4 log10 copies/106 PBMC (IQR = 2.1-2.9, n = 100) at W48 (P = 0.17). The proportion of patients with undetected USpVL was 38% (n = 98), 43% (n = 98) and 49% (n = 97) at D0, W24 and W48, respectively (P = 0.08). Total and unbound plasma dolutegravir concentrations were stable between timepoints (P = 0.13) and all total plasma dolutegravir concentrations except one were adequate. Median free fraction of dolutegravir in plasma was 0.21%. Median blood plasma and seminal plasma concentrations of total dolutegravir at 24 h were 1812 ng/mL and 206 ng/mL, respectively. Median seminal plasma/blood plasma total concentration ratios were 11.6% and 2478% for dolutegravir and lamivudine, respectively. HIV-RNA (365 to 475 copies/mL) was detected in seminal plasma of one patient at D0 (5.9%) and of two patients at W24 (11.8%).
CONCLUSIONS


These findings add further important information regarding the effectiveness of dolutegravir + lamivudine maintenance dual therapy in terms of plasma residual viraemia, cellular reservoir size and drug penetration in the male genital tract.",2020,Total and unbound plasma dolutegravir concentrations were stable between timepoints (P = 0.13) and all total plasma dolutegravir concentrations except one were adequate.,"['ANRS167 LAMIDOL enrolled 104 virologically suppressed patients to switch to dolutegravir\u2009', 'patients receiving dolutegravir\u2009']","['lamivudine', 'lamivudine dual therapy']","['Median free fraction of dolutegravir in plasma', 'Total and unbound blood and seminal plasma drug concentrations', 'HIV-RNA', 'seminal plasma', 'total plasma dolutegravir concentrations', 'ultrasensitive plasma viral load (USpVL) and plasma drug concentrations', 'Median blood plasma and seminal plasma concentrations of total dolutegravir', 'Median seminal plasma/blood plasma total concentration ratios', 'proportion of patients with undetected USpVL', 'Total and unbound plasma dolutegravir concentrations']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}]","[{'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0522531', 'cui_str': 'Free fraction of (qualifier value)'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0242499', 'cui_str': 'Seminal Plasma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",104.0,0.0481551,Total and unbound plasma dolutegravir concentrations were stable between timepoints (P = 0.13) and all total plasma dolutegravir concentrations except one were adequate.,"[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Charpentier', 'Affiliation': 'Université de Paris, INSERM UMR 1137 IAME, F-75018 Paris, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Peytavin', 'Affiliation': 'Université de Paris, INSERM UMR 1137 IAME, F-75018 Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Raffi', 'Affiliation': 'Infectious Diseases Department, CHU Hôtel Dieu and INSERM UIC 1413 Nantes University, Nantes, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Burdet', 'Affiliation': 'Université de Paris, INSERM UMR 1137 IAME, F-75018 Paris, France.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Landman', 'Affiliation': 'Université de Paris, INSERM UMR 1137 IAME, F-75018 Paris, France.'}, {'ForeName': 'Minh P', 'Initials': 'MP', 'LastName': 'Lê', 'Affiliation': 'Université de Paris, INSERM UMR 1137 IAME, F-75018 Paris, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Katlama', 'Affiliation': 'Service de Maladies Infectieuses et Tropicales, Hôpital Pitié-Salpêtrière, AP-HP, Paris, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Collin', 'Affiliation': 'Université de Paris, INSERM UMR 1137 IAME, F-75018 Paris, France.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Benalycherif', 'Affiliation': ""IMEA, Fondation Léon M'ba, Paris, France.""}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Cabie', 'Affiliation': 'Université des Antilles and Service de Maladies Infectieuses et Tropicales, CHU de Martinique, Fort de France, France.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Mentré', 'Affiliation': 'Université de Paris, INSERM UMR 1137 IAME, F-75018 Paris, France.'}, {'ForeName': 'Yazdan', 'Initials': 'Y', 'LastName': 'Yazdanpanah', 'Affiliation': 'Université de Paris, INSERM UMR 1137 IAME, F-75018 Paris, France.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Descamps', 'Affiliation': 'Université de Paris, INSERM UMR 1137 IAME, F-75018 Paris, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Joly', 'Affiliation': 'Université de Paris, INSERM UMR 1137 IAME, F-75018 Paris, France.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa035']
1920,30924265,"Exercise training in patients with a left ventricular assist device (Ex-VAD): rationale and design of a multicentre, prospective, assessor-blinded, randomized, controlled trial.","AIMS


Left ventricular assist device (LVAD) therapy is a promising option for patients with advanced heart failure (HF), refractory to guideline-mandated medical treatment either as a bridge to heart transplantation or as lifelong therapy. Functional capacity improves after LVAD implantation but remains reduced in patients with long-term LVAD therapy. Exercise training (ET) improves functional capacity and quality of life (QoL) in HF and may provide incremental benefits in patients supported with LVAD therapy.
METHODS


The primary objective of Ex-VAD is to investigate whether a 12-week supervised ET can improve peak oxygen uptake (peakVO 2  ) measured by cardiopulmonary exercise testing (CPET) on an ergometer. The study is powered to demonstrate a group difference of 3 mL/min/kg in peakVO 2  at week 12, with a power of 0.9 and a standard deviation of 5 mL/min/kg. After baseline assessments to determine whether ET is safe, 66 patients at six trial sites with advanced HF and LVAD therapy will be randomized 2:1 to supervised ET or to the control arm of usual care alone. Patients randomized to ET will perform supervised aerobic endurance and resistance ET (three times/week) for 12 weeks. At baseline and during follow-up, anthropometry, CPET, echocardiography (at rest and exercise), and QoL evaluation will be performed. Blood samples will be collected to examine cardiac-specific relevant biomarkers. Overall physical activity, training sessions, and adherence will be monitored and documented throughout the study using accelerometers and patient diaries.
CONCLUSIONS


The Ex-VAD trial will assess the effects of a supervised ET programme on peakVO 2  and QoL in patients with LVAD. As LVAD therapy moves from crisis support to ambulatory functional enhancement, this trial will provide a rationale to improve functional capacity and, in perspective, cardiovascular outcomes in LVAD-supported patients with advanced HF.",2019,"Exercise training (ET) improves functional capacity and quality of life (QoL) in HF and may provide incremental benefits in patients supported with LVAD therapy.
","['patients with advanced HF', 'patients with advanced heart failure (HF', 'patients with LVAD', '66 patients at six trial sites with advanced HF and LVAD therapy', 'patients supported with LVAD therapy', 'patients with long-term LVAD therapy', 'patients with a left ventricular assist device (Ex-VAD']","['cardiopulmonary exercise testing (CPET', 'Exercise training (ET', 'Left ventricular assist device (LVAD) therapy', 'Exercise training', 'supervised ET programme']","['functional capacity and quality of life (QoL', 'peak oxygen uptake (peakVO 2  ', 'Overall physical activity, training sessions, and adherence', 'Functional capacity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0085842', 'cui_str': 'Artificial Ventricle'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0055954', 'cui_str': 'CPET'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0034380'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",,0.080522,"Exercise training (ET) improves functional capacity and quality of life (QoL) in HF and may provide incremental benefits in patients supported with LVAD therapy.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bobenko', 'Affiliation': 'Department of Internal Medicine and Cardiology, Charité University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Schoenrath', 'Affiliation': 'DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Berlin, Germany.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Knierim', 'Affiliation': 'Department of Cardiothoracic Surgery, Deutsches Herzzentrum Berlin (DHZB), Berlin, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Friede', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Verheyen', 'Affiliation': 'Department of Cardiology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Mandeep R', 'Initials': 'MR', 'LastName': 'Mehra', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Haykowsky', 'Affiliation': 'College of Nursing and Health Innovation, University of Texas at Arlington, Arlington, TX, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Herrmann-Lingen', 'Affiliation': 'DZHK (German Centre for Cardiovascular Research), Partner Site Göttingen, Göttingen, Germany.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Duvinage', 'Affiliation': 'Department of Prevention, Rehabilitation and Sports Medicine, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Pieske-Kraigher', 'Affiliation': 'Department of Internal Medicine and Cardiology, Charité University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Halle', 'Affiliation': 'Department of Prevention, Rehabilitation and Sports Medicine, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Falk', 'Affiliation': 'DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Berlin, Germany.'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Department of Internal Medicine and Cardiology, Charité University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Edelmann', 'Affiliation': 'Department of Internal Medicine and Cardiology, Charité University Medicine Berlin, Berlin, Germany.'}]",European journal of heart failure,['10.1002/ejhf.1431']
1921,31326345,"Faecal microbiota transplantation for diarrhoea-predominant irritable bowel syndrome: a double-blind, randomised, placebo-controlled trial.","BACKGROUND


Faecal microbiota transplantation (FMT) has shown promise in alleviating the symptoms of irritable bowel syndrome (IBS); however, controlled data on this technique are scarce. The aim of this clinical trial was to assess the efficacy of FMT in alleviating diarrhoea-predominant IBS (IBS-D).
METHODS


We did a double-blind, randomised, placebo-controlled crossover trial in patients aged 18-65 years with moderate-to-severe IBS-D defined by an IBS-Symptom Severity Score (IBS-SSS) of more than 175, recruited from three US centres. Patients were randomly assigned (1:1) in blocks of four with a computer-generated randomisation sequence to receive FMT capsules followed by identical-appearing placebo capsules, or placebo capsules followed by FMT capsules. All participants and study team members were masked to randomisation. An independent staff member assigned the treatments according to consecutive numbers. Patients received either 75 FMT capsules (each capsule contained approximately 0·38 g of minimally processed donor stool) or 75 placebo capsules over 3 days (25 capsules per day). All patients crossed over to the alternate treatment at 12 weeks. The primary outcome was difference in IBS-SSS between the groups at 12 weeks. Intention-to-treat analyses were done and all patients who received study drug were included in an adverse events analysis. The trial was terminated during recruitment because results from an interim analysis revealed futility. The study is registered with ClinicalTrials.gov, number NCT02328547.
FINDINGS


From May 28, 2015, to April 21, 2017, 48 patients were randomly assigned to receive FMT first (n=25) or placebo first (n=23). Three participants were lost to follow-up in the FMT group. IBS-SSS did not differ between FMT recipients (mean 221 [SD 105]) and placebo recipients (236 [95]) at 12 weeks (p=0·65), after adjustment for baseline scores. The most common drug-related adverse events included abdominal pain (five [10%] of the 48 participants while receiving FMT capsules vs four [8%] while receiving placebo), nausea (four [8%] vs two [4%]), and exacerbation of diarrhoea (three [6%] vs eight [17%]). One serious adverse event that was unrelated to study drug (acute cholecystitis) was reported in a patient while receiving placebo capsules.
INTERPRETATION


FMT was safe, but did not induce symptom relief at 12 weeks compared with placebo. Additional studies are needed to determine the efficacy of FMT for IBS-D.
FUNDING


National Institutes of Health.",2019,"One serious adverse event that was unrelated to study drug (acute cholecystitis) was reported in a patient while receiving placebo capsules.
","['diarrhoea-predominant irritable bowel syndrome', 'recipients (mean 221', 'From May 28, 2015, to April 21, 2017, 48 patients', 'patients aged 18-65 years with moderate-to-severe IBS-D defined by an IBS-Symptom Severity Score (IBS-SSS) of more than 175, recruited from three US centres']","['Faecal microbiota transplantation (FMT', 'FMT capsules followed by identical-appearing placebo capsules, or placebo capsules followed by FMT capsules', 'FMT', 'placebo', 'Faecal microbiota transplantation', '75 FMT capsules (each capsule contained approximately 0·38']","['abdominal pain', 'IBS-SSS', 'exacerbation of diarrhoea', 'diarrhoea-predominant IBS (IBS-D', 'symptom relief', 'nausea']","[{'cui': 'C1262211', 'cui_str': 'Diarrhoea predominant irritable bowel syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal Transplantation'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",75.0,0.821614,"One serious adverse event that was unrelated to study drug (acute cholecystitis) was reported in a patient while receiving placebo capsules.
","[{'ForeName': 'Olga C', 'Initials': 'OC', 'LastName': 'Aroniadis', 'Affiliation': 'Department of Medicine, Montefiore Medical Center, Bronx, NY, USA; Albert Einstein College of Medicine, Bronx, NY, USA. Electronic address: oaroniad@montefiore.org.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Brandt', 'Affiliation': 'Department of Medicine, Montefiore Medical Center, Bronx, NY, USA; Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Oneto', 'Affiliation': 'Department of Medicine, New York University Medical Center, New York, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Feuerstadt', 'Affiliation': 'Department of Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Sherman', 'Affiliation': 'Department of Medicine, New York University Medical Center, New York, NY, USA.'}, {'ForeName': 'Allan W', 'Initials': 'AW', 'LastName': 'Wolkoff', 'Affiliation': 'Department of Medicine, Montefiore Medical Center, Bronx, NY, USA; Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Zain', 'Initials': 'Z', 'LastName': 'Kassam', 'Affiliation': 'Finch Therapeutics Group, Somerville, MA, USA.'}, {'ForeName': 'Rotem Gura', 'Initials': 'RG', 'LastName': 'Sadovsky', 'Affiliation': 'Finch Therapeutics Group, Somerville, MA, USA.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Elliott', 'Affiliation': 'OpenBiome, Cambridge, MA, USA.'}, {'ForeName': 'Shrish', 'Initials': 'S', 'LastName': 'Budree', 'Affiliation': 'OpenBiome, Cambridge, MA, USA; University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Marla J', 'Initials': 'MJ', 'LastName': 'Keller', 'Affiliation': 'Department of Medicine, Montefiore Medical Center, Bronx, NY, USA; Albert Einstein College of Medicine, Bronx, NY, USA.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30198-0']
1922,32087841,Motivational interviewing and culture for urban Native American youth (MICUNAY): A randomized controlled trial.,"To date, few programs that integrate traditional practices with evidence-based practices have been developed, implemented, and evaluated with urban American Indians/Alaska Natives (AI/ANs) using a strong research design. The current study recruited urban AI/AN teens across northern, central, and southern California during 2014-2017 to participate in a randomized controlled trial testing two cultural interventions that addressed alcohol and other drug (AOD) use. Adolescents were 14-18 years old (inclusive), and either verbally self-identified as AI/AN or were identified as AI/AN by a parent or community member. We tested the added benefit of MICUNAY (Motivational Interviewing and Culture for Urban Native American Youth) to a CWG (Community Wellness Gathering). MICUNAY was a group intervention with three workshops that integrated traditional practices with motivational interviewing. CWGs were cultural events held monthly in each city. AI/AN urban adolescents (N = 185) completed a baseline survey, were randomized to MICUNAY + CWG or CWG only, and then completed a three- and six-month follow-up. We compared outcomes on AOD use, spirituality, and cultural identification. Overall, AOD use remained stable over the course of the study, and we did not find significant differences between these two groups over time. It may be that connecting urban AI/AN adolescents to culturally centered activities and resources is protective, which has been shown in other work with this population. Given that little work has been conducted in this area, longer term studies of AOD interventions with urban AI/AN youth throughout the U.S. are suggested to test the potential benefits of culturally centered interventions.",2020,"Overall, AOD use remained stable over the course of the study, and we did not find significant differences between these two groups over time.","['urban Native American youth (MICUNAY', 'Urban Native American Youth', 'urban AI/AN teens across northern, central, and southern California during 2014-2017 to participate', 'Adolescents were 14-18\xa0years old (inclusive), and either verbally self-identified as AI/AN or were identified as AI/AN by a parent or community member', 'AN urban adolescents (N\xa0=\xa0185) completed a baseline survey']","['Motivational interviewing and culture', 'integrated traditional practices with motivational interviewing', ' CWG or CWG', 'cultural interventions that addressed alcohol and other drug (AOD) use']","['AOD use, spirituality, and cultural identification']","[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}]","[{'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0237104', 'cui_str': 'Spiritualities'}, {'cui': 'C0020792', 'cui_str': 'Identification'}]",,0.0320976,"Overall, AOD use remained stable over the course of the study, and we did not find significant differences between these two groups over time.","[{'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': ""D'Amico"", 'Affiliation': 'RAND Corporation, 1776 Main St., Santa Monica, CA 90401, United States of America. Electronic address: damico@rand.org.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Dickerson', 'Affiliation': 'UCLA Integrated Substance Abuse Programs, Semel Institute for Neuroscience and Human Behavior David Geffen School of Medicine, 11075 Santa Monica Blvd., Ste. 200, Los Angeles, CA 90025, United States of America.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Brown', 'Affiliation': 'RAND Corporation, 1776 Main St., Santa Monica, CA 90401, United States of America.'}, {'ForeName': 'Carrie L', 'Initials': 'CL', 'LastName': 'Johnson', 'Affiliation': 'Sacred Path Indigenous Wellness Center, LA, CA 90017, United States of America.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Klein', 'Affiliation': 'RAND Corporation, 1776 Main St., Santa Monica, CA 90401, United States of America.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Agniel', 'Affiliation': 'RAND Corporation, 1776 Main St., Santa Monica, CA 90401, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.12.011']
1923,26202168,"A comparison of plasma and prostate lycopene in response to typical servings of tomato soup, sauce or juice in men before prostatectomy.","Tomato product consumption and estimated lycopene intake are hypothesised to reduce the risk of prostate cancer. To define the impact of typical servings of commercially available tomato products on resultant plasma and prostate lycopene concentrations, men scheduled to undergo prostatectomy (n 33) were randomised either to a lycopene-restricted control group ( < 5 mg lycopene/d) or to a tomato soup (2-2¾ cups prepared/d), tomato sauce (142-198 g/d or 5-7 ounces/d) or vegetable juice (325-488 ml/d or 11-16·5 fluid ounces/d) intervention providing 25-35 mg lycopene/d. Plasma and prostate carotenoid concentrations were measured by HPLC. Tomato soup, sauce and juice consumption significantly increased plasma lycopene concentration from 0·68 (sem 0·1) to 1·13 (sem 0·09) μmol/l (66 %), 0·48 (sem 0·09) to 0·82 (sem 0·12) μmol/l (71 %) and 0·49 (sem 0·12) to 0·78 (sem 0·1) μmol/l (59 %), respectively, while the controls consuming the lycopene-restricted diet showed a decline in plasma lycopene concentration from 0·55 (sem 0·60) to 0·42 (sem 0·07) μmol/l ( - 24 %). The end-of-study prostate lycopene concentration was 0·16 (sem 0·02) nmol/g in the controls, but was 3·5-, 3·6- and 2·2-fold higher in tomato soup (P= 0·001), sauce (P= 0·001) and juice (P= 0·165) consumers, respectively. Prostate lycopene concentration was moderately correlated with post-intervention plasma lycopene concentrations (r 0·60, P =0·001), indicating that additional factors have an impact on tissue concentrations. While the primary geometric lycopene isomer in tomato products was all-trans (80-90 %), plasma and prostate isomers were 47 and 80 % cis, respectively, demonstrating a shift towards cis accumulation. Consumption of typical servings of processed tomato products results in differing plasma and prostate lycopene concentrations. Factors including meal composition and genetics deserve further evaluation to determine their impacts on lycopene absorption and biodistribution.",2015,"Tomato soup, sauce and juice consumption significantly increased plasma lycopene concentration from 0·68 (sem 0·1) to 1·13 (sem 0·09) μmol/l (66 %), 0·48 (sem 0·09) to 0·82","['men before prostatectomy', 'men scheduled to undergo prostatectomy (n 33']","['lycopene-restricted control group ( < 5 mg lycopene/d) or to a tomato soup (2-2¾ cups prepared/d), tomato sauce', 'typical servings of commercially available tomato products', 'plasma and prostate lycopene', 'vegetable juice']","['Plasma and prostate carotenoid concentrations', 'Prostate lycopene concentration', 'plasma and prostate isomers', 'plasma and prostate lycopene concentrations', 'plasma lycopene concentration']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0065331', 'cui_str': 'lycopene'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1140676', 'cui_str': 'Solanum lycopersicum'}, {'cui': 'C0453399', 'cui_str': 'Soup (substance)'}, {'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0453373', 'cui_str': 'Tomato sauce (substance)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C1268569', 'cui_str': 'Vegetable Juices'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0007271', 'cui_str': 'Carotenes and Carotenoids'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0065331', 'cui_str': 'lycopene'}]",33.0,0.0277621,"Tomato soup, sauce and juice consumption significantly increased plasma lycopene concentration from 0·68 (sem 0·1) to 1·13 (sem 0·09) μmol/l (66 %), 0·48 (sem 0·09) to 0·82","[{'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Grainger', 'Affiliation': 'Division of Oncology, Department of Internal Medicine, College of Medicine, The Ohio State University,A456 Starling Loving Hall, 320 West 10th Avenue,Columbus,OH43210,USA.'}, {'ForeName': 'Craig W', 'Initials': 'CW', 'LastName': 'Hadley', 'Affiliation': 'Department of Food Science and Technology,College of Food, Agriculture, and Environmental Sciences, The Ohio State University,Columbus,OH43210,USA.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Moran', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, College of Medicine, The Ohio State University,Columbus,OH43210,USA.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Riedl', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, College of Medicine, The Ohio State University,Columbus,OH43210,USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Gong', 'Affiliation': 'Department of Urology,College of Medicine, The Ohio State University,Columbus,OH43210,USA.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Pohar', 'Affiliation': 'Department of Urology,College of Medicine, The Ohio State University,Columbus,OH43210,USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Schwartz', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, College of Medicine, The Ohio State University,Columbus,OH43210,USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Clinton', 'Affiliation': 'Division of Oncology, Department of Internal Medicine, College of Medicine, The Ohio State University,A456 Starling Loving Hall, 320 West 10th Avenue,Columbus,OH43210,USA.'}]",The British journal of nutrition,['10.1017/S0007114515002202']
1924,31201692,"The Use of Intraperitoneal Bupivacaine in Laparoscopic Roux-en-Y Gastric Bypass: a Double-blind, Randomized Controlled Trial.","BACKGROUND


Several studies have shown a reduction in postoperative pain and length of hospital stay when using intraperitoneal local anesthetics during laparoscopic surgery. In morbidly obese patients, respiratory depression due to opioid use is a serious side effect. Any different type of analgesia is therefore clinically relevant.
OBJECTIVE


To assess the effect of intraperitoneal bupivacaine on postoperative pain after laparoscopic Roux-en-Y gastric bypass (LRYGB).
METHODS


Between March and November 2017, 130 patients were included and randomly assigned to receive 20 ml or 0 ml of 2.5% bupivacaine hydrochloride sprayed onto the diaphragm. Pain scores for abdominal and shoulder pain were conducted using the visual analogue scale (VAS) for pain score at 0, 1, 6, and 24 h postoperatively. The length of hospital stay and use of analgesics was recorded in digital patient records. The primary outcome is the pain scores and the secondary outcomes are postoperative use of opioids or antiemetics and length of hospital stay.
RESULTS


The study and control group contained respectively 66 and 61 patients. Patient characteristics were equal in both groups (p < 0.05), except for age. No significant reduction of postoperative pain or opioid use was seen with the use of intraperitoneal bupivacaine. There was also no significant reduction in the use of antiemetics and length of hospital stay.
CONCLUSION


The use of intraperitoneal bupivacaine in LRYGB does not show a statistically significant reduction in postoperative pain or postoperative opioid use. Therefore, using intraperitoneal bupivacaine has no clinical relevance and should no longer be used in LRYGB.",2019,The use of intraperitoneal bupivacaine in LRYGB does not show a statistically significant reduction in postoperative pain or postoperative opioid use.,"['Between March and November 2017, 130 patients', 'morbidly obese patients', 'Laparoscopic Roux-en-Y Gastric Bypass', 'after laparoscopic Roux-en-Y gastric bypass (LRYGB']","['Intraperitoneal Bupivacaine', '20\xa0ml or 0\xa0ml of 2.5% bupivacaine hydrochloride sprayed onto the diaphragm', 'intraperitoneal bupivacaine']","['postoperative pain', 'Pain scores for abdominal and shoulder pain', 'pain scores', 'length of hospital stay and use of analgesics', 'postoperative pain and length of hospital stay', 'postoperative use of opioids or antiemetics and length of hospital stay', 'antiemetics and length of hospital stay', 'postoperative pain or postoperative opioid use', 'visual analogue scale (VAS) for pain score']","[{'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}]","[{'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",130.0,0.113993,The use of intraperitoneal bupivacaine in LRYGB does not show a statistically significant reduction in postoperative pain or postoperative opioid use.,"[{'ForeName': 'Iris E', 'Initials': 'IE', 'LastName': 'Schipper', 'Affiliation': 'Department of Surgery, Flevoziekenhuis, Hospitaalweg 1, 1315 RA, Almere, The Netherlands. iris.schipper@hotmail.com.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Schouten', 'Affiliation': 'Department of Surgery, Flevoziekenhuis, Hospitaalweg 1, 1315 RA, Almere, The Netherlands.'}, {'ForeName': 'Tugba', 'Initials': 'T', 'LastName': 'Yalcin', 'Affiliation': 'Department of Surgery, Flevoziekenhuis, Hospitaalweg 1, 1315 RA, Almere, The Netherlands.'}, {'ForeName': 'Gijs D', 'Initials': 'GD', 'LastName': 'Algie', 'Affiliation': 'Bravis Hospital, Roosendaal, The Netherlands.'}, {'ForeName': 'Stefan L', 'Initials': 'SL', 'LastName': 'Damen', 'Affiliation': 'Medical Center Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Smeenk', 'Affiliation': 'Albert Schweitzer Hospital, Dordrecht, The Netherlands.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Schouten', 'Affiliation': 'Department of Surgery, Flevoziekenhuis, Hospitaalweg 1, 1315 RA, Almere, The Netherlands.'}]",Obesity surgery,['10.1007/s11695-019-03982-6']
1925,31347096,Immune Globulin Subcutaneous (Human) 20% (Hizentra ® ): A Review in Chronic Inflammatory Demyelinating Polyneuropathy.,"Intravenous immunoglobulin (IVIg) is well-established in the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP). Immune globulin subcutaneous (human) 20% liquid (Hizentra ® ; referred to as IgPro20 hereafter) has recently been approved in a number of countries, including the USA and those of the EU, as maintenance therapy in patients with CIDP. In the pivotal phase III PATH trial in adults with CIDP who were first stabilized on IVIg therapy, maintenance therapy with IgPro20 for 24 weeks significantly reduced CIDP relapse or study withdrawal rates versus placebo. Efficacy was sustained during ≤ 48 weeks of additional treatment with IgPro20 in the open-label PATH extension study. IgPro20 was generally well tolerated, with low rates of systemic adverse events (AEs); the most common AEs were local reactions (e.g. infusion-site erythema, infusion-site swelling). In PATH, more than one-half of IgPro20 recipients preferred this therapy to their previous IVIg therapy. IgPro20 offers a convenient alternative to IVIg with a better systemic AEs profile and thus extends the options for maintenance therapy in CIDP.",2019,"IgPro20 was generally well tolerated, with low rates of systemic adverse events (AEs); the most common AEs were local reactions (e.g. infusion-site erythema, infusion-site swelling).","['patients with chronic inflammatory demyelinating polyneuropathy (CIDP', 'adults with CIDP', 'patients with CIDP']","['Intravenous immunoglobulin (IVIg', 'placebo', 'Immune globulin subcutaneous (human) 20% liquid (Hizentra ® ', 'Immune Globulin Subcutaneous (Human) 20% (Hizentra ® ']","['Efficacy', 'CIDP relapse or study withdrawal rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0393819', 'cui_str': 'Inflammatory Polyradiculopathy, Chronic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1703576', 'cui_str': 'Immune Globulin Subcutaneous (Human)'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C2746518', 'cui_str': 'Hizentra'}]","[{'cui': 'C0393819', 'cui_str': 'Inflammatory Polyradiculopathy, Chronic'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",,0.110509,"IgPro20 was generally well tolerated, with low rates of systemic adverse events (AEs); the most common AEs were local reactions (e.g. infusion-site erythema, infusion-site swelling).","[{'ForeName': 'Yvette N', 'Initials': 'YN', 'LastName': 'Lamb', 'Affiliation': 'Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. demail@springer.com.'}, {'ForeName': 'Yahiya Y', 'Initials': 'YY', 'LastName': 'Syed', 'Affiliation': 'Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.'}, {'ForeName': 'Sohita', 'Initials': 'S', 'LastName': 'Dhillon', 'Affiliation': 'Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.'}]",CNS drugs,['10.1007/s40263-019-00655-x']
1926,32072838,Parental quality of life and self-efficacy in pediatric asthma.,"Objective:  Self-efficacy is the personal belief that a behavior can produce a desired result; and in asthma, self-efficacy in asthma care has been related to improvements in asthma outcomes and children's quality of life. To appreciate the full burden of asthma on families, the relationship between parental self-efficacy and quality of life also needs further study. We aim to characterize this relationship. Methods:  Secondary analysis of measurements of parents of children with persistent asthma ( n  = 252; ages 4-17 years) from a large urban area were identified from a randomized trial; the association between baseline assessments of parental quality of life, measured by the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ), and parental self-efficacy, measured through the Parental Asthma Management Self-Efficacy Scale (PAMSES), were examined through multivariable linear regression. Results:  Parental self-efficacy in asthma was positively associated with quality of life among parents of racially and ethnically diverse children ( p  = 0.01). Confidence in using medications correctly ( p  = 0.03), having inhalers during a child's serious breathing problem ( p  = 0.02), and knowing which medications to use during a child's serious breathing problem ( p  = 0.04) were associated with a clinically meaningful difference in parental quality of life. Other significant factors associated with parental quality of life included Hispanic/Latino ethnicity ( p  < 0.01) of the child and Asthma Control Test scores ( p  < 0.01). Conclusion:  The findings suggest that improving parental confidence on when and how to use their child's asthma medications, particularly during an asthma attack, might be clinically meaningful in enhancing parent's quality of life.",2020,Parental self-efficacy in asthma was positively associated with quality of life among parents of racially and ethnically diverse children ( p  = 0.01).,"['pediatric asthma', 'parents of children with persistent asthma ( n \u2009=\u2009252; ages 4-17\u2009years) from a large urban area']",[],"['parental quality of life included Hispanic/Latino ethnicity', 'parental quality of life', 'quality of life', ""parental quality of life, measured by the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ), and parental self-efficacy, measured through the Parental Asthma Management Self-Efficacy Scale (PAMSES"", 'Parental quality of life and self-efficacy']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",[],"[{'cui': 'C0034380'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1318955', 'cui_str': 'Asthma management'}, {'cui': 'C0222045'}]",,0.0278782,Parental self-efficacy in asthma was positively associated with quality of life among parents of racially and ethnically diverse children ( p  = 0.01).,"[{'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Kan', 'Affiliation': ""Division of Academic General Pediatrics and Mary Ann & J. Milburn Smith Child Health Research, Outreach, and Advocacy Center, Stanley Manne Children's Research Institute, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.""}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Fierstein', 'Affiliation': 'Feinberg School of Medicine, Institute for Public Health and Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Boon', 'Affiliation': 'Feinberg School of Medicine, Institute for Public Health and Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Madeleine Kanaley', 'Affiliation': 'Feinberg School of Medicine, Institute for Public Health and Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Zavos', 'Affiliation': ""Mary Ann & J. Milburn Smith Child Health Research, Outreach, and Advocacy Center, Stanley Manne Children's Research Institute, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Volerman', 'Affiliation': 'Department of Medicine and Pediatrics, University of Chicago Medicine, Chicago, IL, USA.'}, {'ForeName': 'Deneen', 'Initials': 'D', 'LastName': 'Vojta', 'Affiliation': 'Global Research & Development, United Health Group, Minnetonka, MN, USA.'}, {'ForeName': 'Ruchi S', 'Initials': 'RS', 'LastName': 'Gupta', 'Affiliation': ""Division of Academic General Pediatrics and Mary Ann & J. Milburn Smith Child Health Research, Outreach, and Advocacy Center, Stanley Manne Children's Research Institute, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.""}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1731825']
1927,31377477,Survival outcomes of the NeoALTTO study (BIG 1-06): updated results of a randomised multicenter phase III neoadjuvant clinical trial in patients with HER2-positive primary breast cancer.,"BACKGROUND


Lapatinib (L) plus trastuzumab (T) with weekly paclitaxel significantly increased the pathologic complete response (pCR) rate compared with the anti-human epidermal growth factor receptor 2 (HER2) agent alone plus paclitaxel. The event-free survival (EFS) and overall survival (OS) by the treatment arms L + T vs. T and L vs. T and the relationship between pCR and EFS/OS both in the whole study population and according to hormone receptor-negative and hormone receptor-positive cohorts after a median follow-up of 6.7 years were assessed.
PATIENTS AND METHODS


Four hundred fifty-five patients with HER2-positive early breast cancer randomly received L 1500 mg/day (n = 154), T (common dose, n = 149) or L 1000 mg/day plus T (n = 152) for 6 weeks, followed by the assigned anti-HER2 treatment combined with paclitaxel weekly × 12. After surgery, patients received 3 cycles of fluorouracil, epirubicin and cyclophosphamide. The primary end-point was pCR (ypT0/is; for current analysis, it is ypT0/is ypN0), and the secondary end-points were EFS and OS.
RESULTS


Six-year EFS rates were 67%, 67% and 74% with L, T and L + T, respectively (L vs T: hazard ratio [HR], 0.98 [95% confidence interval {CI}, 0.64-1.51; P = .93]; L + T vs T: HR, 0.81 [95% CI, 0.52-1.26; P = .35]). Six-Year OS rates were 82%, 79% and 85% for L, T and L + T, respectively (L vs T: HR, 0.85 [95% CI, 0.49-1.46; P = .56]; L + T vs T: HR, 0.72 [95% CI, 0.41-1.27; P = .26]). In landmark analyses, patients with a pCR had a significantly higher 6-year EFS (77% and 65%) and OS (89% and 77%) compared with those without a pCR for both overall and the hormone receptor-negative cohort.
CONCLUSION


Achieving a pCR is important in HER2-positive disease and translates into better long-term outcome with regard to EFS and OS.",2019,"Six-Year OS rates were 82%, 79% and 85% for L, T and L + T, respectively (L vs T: HR, 0.85","['patients with HER2-positive primary breast cancer', 'Four hundred fifty-five\xa0patients with HER2-positive early breast cancer']","['L 1000\xa0mg/day plus T', 'Lapatinib (L) plus trastuzumab (T) with weekly paclitaxel', 'paclitaxel', 'fluorouracil, epirubicin and cyclophosphamide', 'HER2 treatment combined with paclitaxel']","['Survival outcomes', '6-year EFS', 'Six-Year OS rates', 'event-free survival (EFS) and overall survival (OS', 'pathologic complete response (pCR) rate', 'OS', 'Six-year EFS rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",,0.35396,"Six-Year OS rates were 82%, 79% and 85% for L, T and L + T, respectively (L vs T: HR, 0.85","[{'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'University of Ulm, Breast Center, Ulm, Germany. Electronic address: jens.huober@uniklinik-ulm.de.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Holmes', 'Affiliation': 'Frontier Science (Scotland) Ltd, Grampian View, Kincraig, Kingussie, United Kingdom.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Baselga', 'Affiliation': 'Executive Vice President, Research & Development Oncology, AstraZeneca, United Kingdom.'}, {'ForeName': 'Evandro', 'Initials': 'E', 'LastName': 'de Azambuja', 'Affiliation': 'Institut Jules Bordet and Breast European Adjuvant Study Team, Brussels, Belgium.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Head of Breast Cancer Center, Department of Gynecology, Gynecologic Oncology and Obstetrics, HELIOS Klinikum Berlin, Buch, Germany.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Fumagalli', 'Affiliation': 'Breast International Group, Brussels, Belgium.'}, {'ForeName': 'Severine', 'Initials': 'S', 'LastName': 'Sarp', 'Affiliation': 'Novartis Pharma AG, Oncology Development Unit, Basel, Switzerland.'}, {'ForeName': 'Istvan', 'Initials': 'I', 'LastName': 'Lang', 'Affiliation': 'Istenhegyi Gendiagnosztika Private Health Center, Oncology Clinic, Budapest, Hungary.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Smith', 'Affiliation': 'Royal Marsden Hospital and Institute of Cancer Research, London, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Boyle', 'Affiliation': 'Patricia Ritchie Centre for Cancer Care and Research, The University of Sydney, Mater Hospital, North Sydney, Australia.'}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecocq', 'Affiliation': 'Institut Jules Bordet and Breast European Adjuvant Study Team, Brussels, Belgium.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Wildiers', 'Affiliation': 'KU Leuven - University of Leuven, Department of General Medical Oncology, University Hospitals Leuven, B-3000, Leuven, Belgium.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Jouannaud', 'Affiliation': 'CRLCC Jean Godinot, Reims, France.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hackman', 'Affiliation': 'Marien-Hospital Witten, Witten, Germany.'}, {'ForeName': 'Lokanatha', 'Initials': 'L', 'LastName': 'Dasappa', 'Affiliation': 'Kidwai Memorial Institute of Oncology, Bangalore, India.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ciruelos', 'Affiliation': 'Hospital Doce de Octubre, Madrid, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Toral Pena', 'Affiliation': 'Hospital Torrevieja-Salud, Torrevieja, Spain.'}, {'ForeName': 'Hryhoriy', 'Initials': 'H', 'LastName': 'Adamchuk', 'Affiliation': 'Krivoy Rog City Oncology Centre, Krivoy Rog, Ukraine.'}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Hickish', 'Affiliation': 'Royal Bournemouth Hospital & Bournemouth University, Bournemouth, United Kingdom.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'de la Pena', 'Affiliation': 'SOLTI - Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jackisch', 'Affiliation': 'Sana Klinikum Offenbach, Offenbach, Germany.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': 'Department of Data Sciences, Dana-Farber Cancer Institute, Harvard Medical School, Harvard T.H. Chan School of Public Health and Frontier Science and Technology Research Foundation, Boston, USA.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart-Gebhart', 'Affiliation': 'Department of Medicine, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Di Cosimo', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; SOLTI Breast Cancer Research Group, Barcelona, Spain.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.04.038']
1928,32079428,"Shimian granules improve sleep, mood and performance of shift nurses in association changes in melatonin and cytokine biomarkers: a randomized, double-blind, placebo-controlled pilot study.","Shift nurses are prone to sleep problems and impaired nighttime alertness, with risk for reduced health status plus decreased performance, handling errors, and workplace accidents. Attention to and improvements in the situation of shift nurses are urgent. Shimian granules (SMG), an improved formula of Jieyuanshen with liver  qingre  and  yangxin  tranquilizing effects, for more than a decade has been used in China as a herbal treatment of sleep disorders in clinical practice. However, clinical data on SMG have rarely been reported. This double-blinded, randomized, placebo-controlled, pilot clinical trial (ChiCTR-IOR-17013031) aimed to explore whether Shimian granules (SMG) improves sleep and affective state in shift nurses and in association with changes in concentrations of salivary cytokines. Fifty-three rotating-shift female nurses with a Pittsburgh Sleep Quality Index (PSQI) score ≥8 were orally treated with 10.0 g SMG or placebo 2 times daily (30 min after breakfast and 30 min before bed) for 1 month. The Insomnia Severity Index (ISI), a psychomotor vigilance task, Hospital Anxiety and Depression Scale (HADS-A/HADS-D), and levels of four salivary cytokines were evaluated by single time-of-day sampling at baseline and after 1 month of treatment. Significantly lower ISI, HADS, HADS-A, and HADS-D scores, but higher 1/mean reaction time (1/mRT) score, were found in shift nurses treated with SMG than in those who received placebo, and these effects were associated with changes in salivary melatonin, TNF, IL-1β, and IL-6 levels. These latter findings suggest melatonin, TNF, and IL-6 levels may be suitable biomarkers of ISI score in shift nurses, whereas TNF level may be a suitable biomarker of 1/mRT score and IL-6 level a suitable biomarker of HADS score in response to SMG treatment. The results of this pilot study suggest SMG can effectively improve sleep, alertness, plus anxiety and depression symptoms in shift nurses in association with changes in salivary cytokine levels. The results of this study provide an experimental basis for the evaluation of traditional Chinese medicines for the treatment of insomnia and underlying mechanisms of their actions that require detailed future exploration.",2020,"The Insomnia Severity Index (ISI), a psychomotor vigilance task, Hospital Anxiety and Depression Scale (HADS-A/HADS-D), and levels of four salivary cytokines were evaluated by single time-of-day sampling at baseline and after 1 month of treatment.",['Fifty-three rotating-shift female nurses with a Pittsburgh Sleep Quality Index (PSQI) score ≥8'],"['placebo', 'SMG or placebo', 'SMG', 'Shimian granules (SMG']","['performance, handling errors, and workplace accidents', 'sleep, mood and performance of shift nurses', 'sleep and affective state', 'salivary melatonin, TNF, IL-1β, and IL-6 levels', 'ISI, HADS, HADS-A, and HADS-D scores', 'sleep, alertness, plus anxiety and depression symptoms', 'reaction time (1/mRT) score', 'Insomnia Severity Index (ISI), a psychomotor vigilance task, Hospital Anxiety and Depression Scale (HADS-A/HADS-D), and levels of four salivary cytokines']","[{'cui': 'C0231458', 'cui_str': 'Rotated (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C4545801', 'cui_str': 'PSQI (Pittsburgh Sleep Quality Index) score'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3853573', 'cui_str': 'Granules'}]","[{'cui': 'C0018578', 'cui_str': 'Handling'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C1961149', 'cui_str': 'Accidental physical contact (event)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}]",53.0,0.225428,"The Insomnia Severity Index (ISI), a psychomotor vigilance task, Hospital Anxiety and Depression Scale (HADS-A/HADS-D), and levels of four salivary cytokines were evaluated by single time-of-day sampling at baseline and after 1 month of treatment.","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Pharmacy, Affiliated Hospital of Shaanxi University of Chinese Medicine, Xi'an, China.""}, {'ForeName': 'Ruihuan', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Graduate School, Shaanxi University of Chinese Medicine, Xianyang, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': ""Department of Encephalopathy, Traditional Chinese Medicine Hospital of Shaanxi Province, Xi'an, China.""}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Qiao', 'Affiliation': ""Department of Encephalopathy, Traditional Chinese Medicine Hospital of Shaanxi Province, Xi'an, China.""}, {'ForeName': 'Zhenliang', 'Initials': 'Z', 'LastName': 'Hui', 'Affiliation': ""Department of Encephalopathy, Traditional Chinese Medicine Hospital of Shaanxi Province, Xi'an, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Encephalopathy, Traditional Chinese Medicine Hospital of Shaanxi Province, Xi'an, China.""}]",Chronobiology international,['10.1080/07420528.2020.1730880']
1929,32078096,Intracoronary compared with intravenous bolus tirofiban on the microvascular obstruction in patients with STEMI undergoing PCI: a cardiac MR study.,"To investigate the potential effect of intracoronary administration of the glycoprotein IIb/IIIa inhibitor tirofiban on the microvascular obstruction (MVO) assessed by cardiac magnetic resonance (CMR) imaging compared to the intravenous route in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention (PCI). Two hundred eight patients were randomized into two groups (tirofiban i.v. and tirofiban i.c.). CMR was completed within 3-7 days after ST-segment-elevation myocardial infarction. One hundred thirty-two patients had a follow-up CMR at 6 months after discharge. The primary end point was the CMR measurements including myocardium strain, myocardial perfusion index, final infarct size, prevalence and extent of MVO, and the change of left ventricular end-diastolic volume (LVEDV) at six months follow-up. The second endpoint was major adverse cardiovascular events (composite of all-cause death, nonfatal reinfarction and congestive heart failure) in one year. The MVO prevalence and extent [56% versus 36%, p = 0.004; 2.08 (IQR: 1.18-5.07) g versus 1.68 (IQR: 0.30-3.28) g, p = 0.041] showed a significant difference between the intravenous and intracoronary groups. Global left ventricular peak longitudinal strain was significantly different in intracoronary groups compared to intravenous groups, - 12.5 [IQR: - 13.4 to - 10.9] versus - 12.3 [IQR: - 13.4 to - 10.4], respectively (P = 0.042). Infarcted myocardial perfusion index was significantly different in intracoronary groups compared to intravenous groups, 0.11 [IQR: 0.08 to 0.15] versus 0.09 [IQR: 0.07 to 0.14], respectively (P = 0.026). Intracoronary tirofiban was associated with a higher change in LVEDV compared with intravenous group (- 10.2% [IQR: - 13.7% to - 2.6%] versus 1.3% [IQR: - 5.6% to 6.1%], p < 0.001). Intracoronary tirofiban application showed no benefit on the occurrence of major adverse cardiovascular events during follow-up compared to intravenous administration. This CMR study in ST-segment-elevation myocardial infarction patients showed a benefit in MVO and left ventricular remodeling for intracoronary tirofiban administration compared to intravenous administration in patients undergoing PCI.",2020,"The MVO prevalence and extent [56% versus 36%, p = 0.004; 2.08 (IQR: 1.18-5.07)","['patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention (PCI', 'patients with STEMI undergoing PCI', 'Two hundred eight patients', 'patients undergoing PCI']","['Intracoronary tirofiban', 'glycoprotein IIb/IIIa inhibitor tirofiban', 'intracoronary tirofiban', 'intravenous bolus tirofiban', 'Intracoronary', 'tirofiban i.v. and tirofiban', 'cardiac magnetic resonance (CMR) imaging']","['microvascular obstruction', 'CMR', 'microvascular obstruction (MVO', 'major adverse cardiovascular events (composite of all-cause death, nonfatal reinfarction and congestive heart failure', 'Global left ventricular peak longitudinal strain', 'CMR measurements including myocardium strain, myocardial perfusion index, final infarct size, prevalence and extent of MVO, and the change of left ventricular end-diastolic volume (LVEDV', 'occurrence of major adverse cardiovascular events', 'LVEDV', 'Infarcted myocardial perfusion index', 'MVO prevalence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0247025', 'cui_str': 'tirofiban'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0027061', 'cui_str': 'Muscle, Cardiac'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",208.0,0.0251666,"The MVO prevalence and extent [56% versus 36%, p = 0.004; 2.08 (IQR: 1.18-5.07)","[{'ForeName': 'Quanmei', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': ""Department of Radiology, Shengjing Hospital of China Medical University, No. 36 Sanhao Street, Heping District, Shenyang, 110004, Liaoning, People's Republic of China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Department of Radiology, Shengjing Hospital of China Medical University, No. 36 Sanhao Street, Heping District, Shenyang, 110004, Liaoning, People's Republic of China.""}, {'ForeName': 'Xiaonan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Radiology, Shengjing Hospital of China Medical University, No. 36 Sanhao Street, Heping District, Shenyang, 110004, Liaoning, People's Republic of China.""}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, Shengjing Hospital of China Medical University, No. 36 Sanhao Street, Heping District, Shenyang, 110004, Liaoning, People's Republic of China.""}, {'ForeName': 'Tongtong', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': ""Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Duan', 'Affiliation': ""Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Jiake', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Zongyu', 'Initials': 'Z', 'LastName': 'Wen', 'Affiliation': ""Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Yundi', 'Initials': 'Y', 'LastName': 'Jiao', 'Affiliation': ""Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Zhaoqing', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': ""Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': ""Department of Radiology, Shengjing Hospital of China Medical University, No. 36 Sanhao Street, Heping District, Shenyang, 110004, Liaoning, People's Republic of China. houyang_1973@sina.com.""}]",The international journal of cardiovascular imaging,['10.1007/s10554-020-01800-0']
1930,32073955,Improvement in Patient-Reported Outcomes With Intensity-Modulated Radiotherapy (RT) Compared With Standard RT: A Report From the NRG Oncology RTOG 1203 Study.,"PURPOSE


In oncology trials, the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) is the standard tool for reporting adverse events (AEs), but it may underreport symptoms experienced by patients. This analysis of the NRG Oncology RTOG 1203 compared symptom reporting by patients and clinicians during radiotherapy (RT).
PATIENTS AND METHODS


Patients with cervical or endometrial cancer requiring postoperative RT were randomly assigned to standard 4-field RT or intensity-modulated RT (IMRT). Patients completed the 6-item patient-reported outcomes version of the CTCAE (PRO-CTCAE) for GI toxicity assessing abdominal pain, diarrhea, and fecal incontinence at various time points. Patients reported symptoms on a 5-point scale. Clinicians recorded these AEs as CTCAE grades 1 to 5. Clinician- and patient-reported AEs were compared using McNemar's test for rates > 0%.
RESULTS


Of 278 eligible patients, 234 consented and completed the PRO-CTCAE. Patients reported high-grade abdominal pain 19.1% ( P  < .0001), high-grade diarrhea 38.5% ( P  < .0001), and fecal incontinence 6.8% more frequently than clinicians. Similar effects were seen between grade ≥ 1 CTCAE toxicity and any-grade patient-reported toxicity. Between-arm comparison of patient-reported high-grade AEs revealed that at 5 weeks of RT, patients who received IMRT experienced fewer GI AEs than patients who received 4-field pelvic RT with regard to frequency of diarrhea (18.2% difference;  P  = .01), frequency of fecal incontinence (8.2% difference;  P  = .01), and interference of fecal incontinence (8.5% difference;  P  = .04).
CONCLUSION


Patient-reported AEs showed a reduction in symptoms with IMRT compared with standard RT, whereas clinician-reported AEs revealed no difference. Clinicians also underreported symptomatic GI AEs compared with patients. This suggests that patient-reported symptomatic AEs are important to assess in this disease setting.",2020,"Patients reported high-grade abdominal pain 19.1% ( P  < .0001), high-grade diarrhea 38.5% ( P  < .0001), and fecal incontinence 6.8% more frequently than clinicians.","['patients and clinicians during radiotherapy (RT', '278 eligible patients, 234 consented and completed the PRO-CTCAE', 'Patients with cervical or endometrial cancer requiring postoperative RT']","['Standard RT', 'Intensity-Modulated Radiotherapy (RT', 'IMRT', 'standard 4-field RT or intensity-modulated RT (IMRT']","['6-item patient-reported outcomes version of the CTCAE (PRO-CTCAE) for GI toxicity assessing abdominal pain, diarrhea, and fecal incontinence', 'interference of fecal incontinence', 'frequency of fecal incontinence', 'frequency of diarrhea', 'toxicity', 'high-grade abdominal pain', 'high-grade diarrhea', 'fecal incontinence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}]","[{'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}]",278.0,0.168368,"Patients reported high-grade abdominal pain 19.1% ( P  < .0001), high-grade diarrhea 38.5% ( P  < .0001), and fecal incontinence 6.8% more frequently than clinicians.","[{'ForeName': 'Anamaria R', 'Initials': 'AR', 'LastName': 'Yeung', 'Affiliation': 'University of Florida, Gainesville, FL.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Pugh', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, PA.'}, {'ForeName': 'Ann H', 'Initials': 'AH', 'LastName': 'Klopp', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Gil', 'Affiliation': 'Summa Health System, Akron, OH.'}, {'ForeName': 'Lari', 'Initials': 'L', 'LastName': 'Wenzel', 'Affiliation': 'University of California Irvine, Irvine, CA.'}, {'ForeName': 'Shannon N', 'Initials': 'SN', 'LastName': 'Westin', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Gaffney', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Small', 'Affiliation': 'Loyola University Chicago, Chicago, IL.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Thompson', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Desiree E', 'Initials': 'DE', 'LastName': 'Doncals', 'Affiliation': 'Cooper Cancer Center, Summa Akron City Hospital, Akron, OH.'}, {'ForeName': 'Guilherme H C', 'Initials': 'GHC', 'LastName': 'Cantuaria', 'Affiliation': 'Northside Hospital, Atlanta, GA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Yaremko', 'Affiliation': 'London Regional Cancer Program, London, United Kingdom.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': ""Pamela Youde Nethersole Eastern Hospital, Hong Kong, Special Administrative Region, People's Republic of China.""}, {'ForeName': 'Vijayananda', 'Initials': 'V', 'LastName': 'Kundapur', 'Affiliation': 'Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Dasarahally S', 'Initials': 'DS', 'LastName': 'Mohan', 'Affiliation': 'Kaiser Permanente Cancer Treatment Center, South San Francisco, CA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Haas', 'Affiliation': 'Reading Hospital, Reading, PA.'}, {'ForeName': 'Yong Bae', 'Initials': 'YB', 'LastName': 'Kim', 'Affiliation': 'Severance Hospital, Yonsei University Health System, Seoul, South Korea.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Ferguson', 'Affiliation': 'Georgia Regents University, Augusta, GA.'}, {'ForeName': 'Snehal', 'Initials': 'S', 'LastName': 'Deshmukh', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, PA.'}, {'ForeName': 'Deborah W', 'Initials': 'DW', 'LastName': 'Bruner', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Kachnic', 'Affiliation': 'Vanderbilt University School of Medicine, Nashville, TN.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02381']
1931,32084053,Brief Report: Long-Term Follow-up of Smokers Living With HIV After an Intensive Behavioral Tobacco Treatment Intervention.,"INTRODUCTION


Cigarette smoking is extremely common among persons living with HIV (PLWH) in the United States, and it has emerged as a leading killer in this group. No tobacco treatment studied to date has demonstrated long-term efficacy.
METHODS


This was a follow-up study of PLWH adult smokers who completed a randomized controlled trial of positively Smoke Free group therapy from 2014 to 2017. Participants from 2 of the 3 trial sites were recalled to complete a long-term follow-up assessment, at least one year after initial enrollment.
RESULTS


Of the 342 candidates for this follow-up study, 11 had died before our attempts to contact them, and 194 of the remaining 331 (58.6%) completed the late follow-up assessment. Most (91.2%) of the remaining candidates could not be contacted despite numerous attempts. At a mean of 38.1 months after initial study enrollment, using an intention-to-treat, lost to follow-up = still smoking (worst case scenario) strategy, 12.7% of group therapy vs. 6.6% of control participants had biochemically verified 7-day point-prevalence abstinence, odds ratio = 2.06 (95% CI: 0.96-4.41), P = 0.06, and 10.3% of group therapy vs. 4.2% of control participants had biochemically verified 12-month point-prevalence abstinence, odds ratio = 2.61 (95% CI: 1.05-6.47, P = 0.03). Improvements in abstinence self-efficacy in the positively Smoke Free group observed in the original study were sustained through late follow-up.
CONCLUSIONS


Targeted group therapy for PLWH smokers was associated with increased cessation and sustained improvements in abstinence self-efficacy at a mean of more than 3 years of follow-up. This is the first trial to show long-term efficacy of tobacco treatment for PLWH.",2020,"CONCLUSIONS


Targeted group therapy for PLWH smokers was associated with increased cessation and sustained improvements in abstinence self-efficacy at a mean of more than three years of follow-up.","['Participants from two of the three trial sites were recalled to complete a long-term follow-up assessment, at least one year after initial enrollment', 'persons living with HIV (PLWH', 'smokers living with HIV after an intensive behavioral tobacco treatment intervention', 'PLWH adult smokers', 'group therapy from 2014 to 2017', 'Of the 342 candidates for this follow-up study']",['Positively Smoke Free (PSF'],"['abstinence self-efficacy', 'biochemically-verified 7-day point-prevalence abstinence']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",,0.0502146,"CONCLUSIONS


Targeted group therapy for PLWH smokers was associated with increased cessation and sustained improvements in abstinence self-efficacy at a mean of more than three years of follow-up.","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Shuter', 'Affiliation': 'Departments of aEpidemiology and Population Health bMedicine, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Ryung S', 'Initials': 'RS', 'LastName': 'Kim', 'Affiliation': 'Departments of aEpidemiology and Population Health bMedicine, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Durant', 'Affiliation': 'Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Cassandra A', 'Initials': 'CA', 'LastName': 'Stanton', 'Affiliation': 'Behavioral Health and Health Policy Practice, Westat, Rockville, MD.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002330']
1932,31367728,Frailty and Brain-Muscle Correlates in Older People With Type 2 Diabetes: A structural-MRI Explorative Study.,"OBJECTIVES


Muscle alterations, mainly functional alterations are frequently observed in older people with type 2 diabetes (T2DM). Sarcopenia may be one mechanism of transition to frailty in these people. Thus, we aim to explore the characteristics of muscle and its association with cerebral grey matter volumes within this group.
METHODS


Single center study nested within the international MID-Frail (a randomized clinical trial to evaluate the effectiveness of a multi-modal intervention in older people with T2DM on frailty and quality of life) trial participants underwent both brain and muscle T1 MRI, nutritional and functional assessments. Muscle areas were measured in rectus femoris (RF). Relationships between MRI grey matter volumes and muscle areas or function tests were described using positive and negative regressions.
RESULTS


Twenty-six subjects (7 female, mean age 78.2 y, SD 5.0), 6 frail and 20 pre-frail were explored in this sub-study. Frail subjects had lower Mini Nutritional Assessment (MNA), Short Physical Performance Battery (SPPB), hip flexor strength than pre-frail ones but similar BMI and balance. Total SPPB was positively related with hip flexor strength and maximal RF area. Balance SPPB sub-score was unrelated to strength or RF area. MNA score was correlated with hip flexor strength and to global grey matter but not to SPPB. Hip flexor strength was correlated with grey matter areas involved in motor control. Walking time was negatively and rising chair sub-score was positively associated with grey matter volumes of motor areas.
CONCLUSIONS


Sarcopenia features were more frequent in frail than prefrail subjects and were associated with decrease in grey matter volumes involved in motor control.",2019,"Frail subjects had lower Mini Nutritional Assessment (MNA),","['Single center study nested within the international MID-Frail', 'older people with type 2 diabetes (T2DM', 'Frail subjects', 'older people with T2DM on frailty and quality of life', 'Twenty-six subjects (7 female, mean age 78.2 y, SD 5.0), 6 frail and 20 pre-frail', 'Older People With Type 2 Diabetes']",['multi-modal intervention'],"['hip flexor strength and maximal RF area', 'lower Mini Nutritional Assessment (MNA', 'Short Physical Performance Battery (SPPB), hip flexor strength', 'grey matter volumes', 'Total SPPB', 'Balance SPPB sub-score', 'MNA score', 'hip flexor strength', 'Hip flexor strength', 'Walking time']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0034380'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}]","[{'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3850124', 'cui_str': 'Mini Nutrition Assessment'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0018220', 'cui_str': 'Gray Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",26.0,0.0279143,"Frail subjects had lower Mini Nutritional Assessment (MNA),","[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bourdel-Marchasson', 'Affiliation': 'I Bourdel-Marchasson, CNRS/Université de Bordeaux, UMR 5536 Résonance Magnétique des systèmes Biologiques, Bordeaux, France, isabelle.bourdel-marchasson@chu-bordeaux.fr.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Catheline', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Regueme', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Danet-Lamasou', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Barse', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ratsimbazafy', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rodriguez-Manas', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': ''}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Sinclair', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-019-1229-3']
1933,31367733,"Positive Effects of ""Textured Lunches"" Gatherings and Oral Exercises Combined with Physical Exercises on Oral and Physical Function in Older Individuals: A Cluster Randomized Controlled Trial.","OBJECTIVES


Proper nutrition and physical exercises are essential to prevent frailty in older adults. Proper masticatory performance and oral function may influence on physical activities as well since the mouth is the entrance of nutrition and digestion. Thus, the present study aimed to test the combined program of specially devised lunch gatherings containing textured foods with oral and physical exercises on the improvement of oral and physical function in community-dwelling older adults.
DESIGN


A Cluster randomized controlled trial; Setting and Participants: Eighty-six community-dwelling older adults in Daito city, Japan, were randomly assigned into control (n = 43) or intervention (n = 43) groups.
INTERVENTION


The control group performed the physical exercise regimen only. The intervention group participated in a 12-week physical and oral exercise program and ate a so-called ""munchy lunch"" that introduced textured foods with proper nutrients together after performing the physical exercise twice a week following brief dietary instruction at the intervention onset. Physical training and lunch gatherings were held at local public centers.
MEASUREMENTS


The differences in measured variables for physical and oral function between baseline and 12 weeks of intervention were statistically tested.
RESULTS


Oral function as measured by tongue pressure increased significantly in the intervention group (p=0.031), but not in the control group. Physical properties and activities, including body fat percentage and results of the timed up and go test, decreased more significantly in the intervention group than in controls (p<0.05).
CONCLUSIONS


Our findings suggest that a combined program of textured lunch gatherings with oral and physical exercises may improve physical and oral function as a preventative approach for frailty in community-dwelling older adults.",2019,"RESULTS


Oral function as measured by tongue pressure increased significantly in the intervention group (p=0.031), but not in the control group.","['older adults', 'community-dwelling older adults', 'Older Individuals', 'Participants: Eighty-six community-dwelling older adults in Daito city, Japan']","['physical exercise regimen', 'Textured Lunches"" Gatherings and Oral Exercises Combined with Physical Exercises', '12-week physical and oral exercise program and ate a so-called ""munchy lunch"" that introduced textured foods with proper nutrients together after performing the physical exercise', 'Physical training and lunch gatherings', 'lunch gatherings containing textured foods with oral and physical exercises', 'oral and physical exercises']","['Oral and Physical Function', 'oral and physical function', 'physical and oral function', 'tongue pressure']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0449582', 'cui_str': 'With texture (attribute)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",86.0,0.0258752,"RESULTS


Oral function as measured by tongue pressure increased significantly in the intervention group (p=0.031), but not in the control group.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kito', 'Affiliation': 'Koichiro Matsuo, DDS, PhD, Department of Dentistry and Oral-Maxillofacial Surgery, School of Medicine, Fujita Health University, 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan, Phone: +81-562-93-9098 / Fax: +81-562-93-9098, E-mail: kmatsuo@fujita-hu.ac.jp.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Matsuo', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ogawa', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Izumi', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kishima', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Itoda', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Masuda', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-019-1216-8']
1934,31443732,Peer approaches to self-management (PALS): comparing a peer mentoring approach for disease self-management in African American women with lupus with a social support control: study protocol for a randomized controlled trial.,"BACKGROUND


Systemic lupus erythematosus (SLE or lupus) is a chronic autoimmune disease that is associated with increased morbidity, mortality, healthcare costs and decreased quality of life. African Americans in the USA have three to four times greater prevalence of SLE, risk of developing SLE at an earlier age, and SLE-related disease activity, damage, and mortality compared with Caucasians, with the highest rates experienced by African American women. There is strong evidence that patient-level factors are associated with outcomes, which justifies targeting them with intervention. While evidence-based self-management interventions that incorporate both social support and health education have reduced pain, improved function, and delayed disability among patients with SLE, African Americans and women are still disproportionately impacted by SLE. Peer mentoring interventions are effective in other chronic conditions that disproportionately affect minorities, such as diabetes mellitus, HIV, and kidney disease, but there is currently no empirically tested peer mentoring intervention developed for patients with SLE. Preliminary data from our group suggest that peer mentoring improves self-management, reduces disease activity, and improves health-related quality of life (HRQOL) in African American women with SLE.
METHODS


This study will test an innovative, manualized peer mentorship program designed to provide modeling and reinforcement by peers (mentors) to other African American women with SLE (mentees) to encourage them to engage in activities that promote disease self-management. Through a randomized, ""mentored"" or ""support group"" controlled design, we will assess the efficacy and mechanism(s) of this intervention in self-management, disease activity, and HRQOL.
DISCUSSION


This is the first study to test peer mentorship as an alternative strategy to improve outcomes in African American women with SLE. This could result in a model for other programs that aim to improve disease self-management, disease activity, and HRQOL in African American women suffering from chronic illness. The peer mentoring approach is uniquely fitted to African Americans, and this intervention has the potential to lead to health improvements for African American women with SLE that have not been attainable with other interventions. This would significantly reduce disparities and have considerable public health impact.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03734055 . Registered on 27 November 2018.",2019,"African Americans in the USA have three to four times greater prevalence of SLE, risk of developing SLE at an earlier age, and SLE-related disease activity, damage, and mortality compared with Caucasians, with the highest rates experienced by African American women.","['patients with SLE', 'African American women with SLE', 'African American women with lupus with a social support control', 'peers (mentors) to other African American women with SLE (mentees', 'African Americans', 'patients with SLE, African Americans and women', 'African American women suffering from chronic illness']","['Peer approaches to self-management (PALS', 'peer mentoring approach', 'Peer mentoring interventions']","['morbidity, mortality, healthcare costs and decreased quality of life', 'self-management, reduces disease activity, and improves health-related quality of life (HRQOL', 'pain, improved function, and delayed disability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0409974', 'cui_str': 'Lupus erythematosus (disorder)'}, {'cui': 'C0037438'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C4255266', 'cui_str': 'Mentoring'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",,0.0940384,"African Americans in the USA have three to four times greater prevalence of SLE, risk of developing SLE at an earlier age, and SLE-related disease activity, damage, and mortality compared with Caucasians, with the highest rates experienced by African American women.","[{'ForeName': 'Edith M', 'Initials': 'EM', 'LastName': 'Williams', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, 135 Cannon Street, Suite CS303D, Charleston, SC, 29425, USA. wiled@musc.edu.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Egede', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, 8701 Watertown Plank Road, Milwaukee, WI, 53226, USA.'}, {'ForeName': 'Jim C', 'Initials': 'JC', 'LastName': 'Oates', 'Affiliation': 'Division of Rheumatology and Immunology, Medical University of South Carolina, 96 Jonathan Lucas St, Charleston, SC, 29425, USA.'}, {'ForeName': 'Clara L', 'Initials': 'CL', 'LastName': 'Dismuke', 'Affiliation': 'Heath Economics Resource Center (HERC), VA Palo Alto Medical Care System, 795 Willow Road (152 MPD), Menlo Park, CA, 94025, USA.'}, {'ForeName': 'Viswanathan', 'Initials': 'V', 'LastName': 'Ramakrishnan', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, 135 Cannon Street, Suite CS303D, Charleston, SC, 29425, USA.'}, {'ForeName': 'Trevor D', 'Initials': 'TD', 'LastName': 'Faith', 'Affiliation': 'Division of Rheumatology and Immunology, Medical University of South Carolina, 96 Jonathan Lucas St, Charleston, SC, 29425, USA.'}, {'ForeName': 'Hetlena', 'Initials': 'H', 'LastName': 'Johnson', 'Affiliation': 'Lupus Columbia SC, 1900 Kathleen Drive, Columbia, SC, 29210, USA.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Rose', 'Affiliation': 'Department of Social Work Programs, Hospital for Special Surgery, 535 East 70th Street, New York, NY, 10021, USA.'}]",Trials,['10.1186/s13063-019-3580-4']
1935,32078145,"Comparison of the Efficacy and Safety of Adalimumab (Humira) and the Adalimumab Biosimilar Candidate (HS016) in Chinese Patients with Active Ankylosing Spondylitis: A Multicenter, Randomized, Double-Blind, Parallel, Phase III Clinical Trial.","OBJECTIVE


The aim of this study was to evaluate the efficacy and safety of the biosimilar candidate of adalimumab (HS016) compared with adalimumab (Humira) for the treatment of active ankylosing spondylitis.
METHODS


A multicenter, randomized, double-blind, parallel, positive control, phase III clinical trial was conducted at 28 locations in China. Patients with active ankylosing spondylitis were randomized in a 2:1 ratio to subcutaneously receive 40 mg of either HS016 or adalimumab every other week for 24 weeks. The primary endpoint was to achieve at least a 20% improvement (ASAS20) in patients at 24 weeks according to the Assessment of Spondyloarthritis International Society criteria. The secondary endpoint included other efficacy assessment parameters, health evaluations, safety, pharmacokinetic, and immunogenicity parameters.
RESULTS


Following the random assignment of 648 patients into HS016 (n = 416) and adalimumab (n = 232) groups, no significant difference was found in the ASAS20 response rates at 24 weeks between the HS016 (364/416, 87.5%) and adalimumab (209/232, 90.1%) treatments and the difference between the response rates (- 2.59%; 90% confidence interval [CI] - 6.77 to 1.60) was within the predefined equivalence margin (± 15%). There were also no significant differences when the secondary endpoints were compared (all p > 0.05). Similarly, the rates of treatment-emergent adverse events (TEAEs) were not significantly different between the two groups, with most TEAEs being mild to moderate. Only nine severe cases were found, including seven within the HS016 group, three (0.7%) of which were tuberculosis cases. Plasma concentrations of HS016 and adalimumab from weeks 12 to 14 were similar during the steady-state period and steady-state maximal concentration (C max,ss ) was equivalent for HS016 (7356.6 ng/mL) and adalimumab (7600.3 ng/mL). The accumulated proportion of patients with positive human anti-human antibodies (HAHAs) at week 24 was 326/412 (79.1%) in the HS016 group and 183/229 (79.9%) in the adalimumab group (p > 0.05), while the accumulated proportion of patients with positive neutralizing antibody (NAb) tests were 72/412 (17.5%) in the HS016 group and 43/229 (18.8%) in the adalimumab group (p > 0.05).
CONCLUSION


HS016 resembled adalimumab in efficacy and safety over the 24-week treatment period.
TRIAL REGISTRATION NUMBER


ChiCTR1900022520.",2020,"Similarly, the rates of treatment-emergent adverse events (TEAEs) were not significantly different between the two groups, with most TEAEs being mild to moderate.","['Chinese Patients with Active Ankylosing Spondylitis', 'active ankylosing spondylitis', 'Patients with active ankylosing spondylitis', '648 patients into HS016', '28 locations in China']","['Adalimumab (Humira) and the Adalimumab Biosimilar Candidate (HS016', 'adalimumab (HS016', 'HS016 or adalimumab', 'adalimumab', 'HS016', 'adalimumab (Humira']","['ASAS20 response rates', 'efficacy and safety', 'rates of treatment-emergent adverse events (TEAEs', 'efficacy assessment parameters, health evaluations, safety, pharmacokinetic, and immunogenicity parameters', 'Plasma concentrations of HS016 and adalimumab', 'positive neutralizing antibody (NAb) tests', 'achieve at least a 20% improvement (ASAS20', 'response rates']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0038012', 'cui_str': 'Spondylitis'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C1171255', 'cui_str': 'Humira'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",648.0,0.221968,"Similarly, the rates of treatment-emergent adverse events (TEAEs) were not significantly different between the two groups, with most TEAEs being mild to moderate.","[{'ForeName': 'Jinmei', 'Initials': 'J', 'LastName': 'Su', 'Affiliation': 'Department of Rheumatology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, No. 1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Mengtao', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, No. 1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'He', 'Affiliation': ""Department of Rheumatology and Immunology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, China.""}, {'ForeName': 'Dongbao', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Department of Rheumatology, Changhai Hospital, Shanghai, 200433, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Wan', 'Affiliation': 'Department of Rheumatology, Huashan Hospital, Fudan University, Shanghai, 201907, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Rheumatology, West China Hospital, Sichuan University, Chengdu, 610000, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Rheumatology, The First Affiliated Hospital of Anhui Medical University, Hefei, 230001, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Rheumatology, The First Affiliated Hospital of Kunming Medical University, Kunming, 650032, China.'}, {'ForeName': 'Huaxiang', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Rheumatology, Qilu Hospital of Shandong University, Jinan, 250001, China.'}, {'ForeName': 'Lindi', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Rheumatology, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Huaxiang', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Rheumatology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, 310009, China.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Zuo', 'Affiliation': 'Department of Rheumatology, Xiangya Hospital, Central South University, Changsha, 410008, China.'}, {'ForeName': 'Cibo', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Rheumatology, Beijing Hospital, Beijing, 100010, China.'}, {'ForeName': 'Xiumei', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Rheumatology, The First Affiliated Hospital of Shanxi Medical University, Taiyuan, 30001, China.'}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology, The Second Xiangya Hospital of Central South University, Changsha, 410007, China.'}, {'ForeName': 'Zhiyi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology, The First Affiliated Hospital of Harbin Medical University, Harbin, 150001, China.'}, {'ForeName': 'Xiangyuan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Rheumatology, Peking University Third Hospital, Beijing, 100089, China.'}, {'ForeName': 'Lingli', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'Department of Rheumatology, Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Tianwang', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology, Guangdong Second Provincial General Hospital, Guangzhou, 510310, China.'}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Rheumatology, The Third Hospital of Hebei Medical University, Shijiazhuang, 050000, China.'}, {'ForeName': 'Jingyang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology, Zhuzhou Central Hospital, Zhuzhou, 412000, China.'}, {'ForeName': 'Dongyi', 'Initials': 'D', 'LastName': 'He', 'Affiliation': 'Department of Rheumatology, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, 200052, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Department of Rheumatology, China-Japan Friendship Hospital, Beijing, 100020, China.'}, {'ForeName': 'Anbin', 'Initials': 'A', 'LastName': 'Huang', 'Affiliation': 'Department of Rheumatology, Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430022, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Department of Rheumatology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510260, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rheumatology, Jiangsu Province Hospital, Nanjing, 210000, China.'}, {'ForeName': 'Zhuoli', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': 'Department of Rheumatology, Tianjian Medical University General Hospital, Tianjin, 300052, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology, The Second Affiliated Hospital of Shanxi Medical University, Taiyuan, 030001, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'Department of Rheumatology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, No. 1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China. zengxfpumc@163.com.'}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-020-00408-z']
1936,31896620,Safety and efficacy of omaveloxolone in patients with mitochondrial myopathy: MOTOR trial.,"OBJECTIVE


To investigate the safety and efficacy of escalating doses of the semi-synthetic triterpenoid omaveloxolone in patients with mitochondrial myopathy.
METHODS


In cohorts of 8-13, 53 participants were randomized double-blind to 12 weeks of treatment with omaveloxolone 5, 10, 20, 40, 80, or 160 mg, or placebo. Outcome measures were change in peak cycling exercise workload (primary), in 6-minute walk test (6MWT) distance (secondary), and in submaximal exercise heart rate and plasma lactate (exploratory).
RESULTS


No differences in peak workload or 6MWT were observed at week 12 with omaveloxolone treatment vs placebo for all omaveloxolone dose groups. In contrast, omaveloxolone 160 mg reduced heart rate at week 12 by 12.0 ± 4.6 bpm (SE) during submaximal exercise vs placebo,  p  = 0.01, and by 8.7 ± 3.5 bpm (SE) vs baseline,  p  = 0.02. Similarly, blood lactate was 1.4 ± 0.7 mM (SE) lower vs placebo,  p  = 0.04, and 1.6 ± 0.5 mM (SE) lower vs baseline at week 12,  p  = 0.003, with omaveloxolone 160 mg treatment. Adverse events were generally mild and infrequent.
CONCLUSIONS


Omaveloxolone 160 mg was well-tolerated, and did not lead to change in the primary outcome measure, but improved exploratory endpoints lowering heart rate and lactate production during submaximal exercise, consistent with improved mitochondrial function and submaximal exercise tolerance. Therefore, omaveloxolone potentially benefits patients with mitochondrial myopathy, which encourages further investigations of omaveloxolone in this patient group.
CLINICALTRIALSGOV IDENTIFIER


NCT02255422.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that, for patients with mitochondrial myopathy, omaveloxolone compared to placebo did not significantly change peak exercise workload.",2020,No differences in peak workload or 6MWT were observed at week 12 with omaveloxolone treatment vs placebo for all omaveloxolone dose groups.,"['patients with mitochondrial myopathy (MOTOR trial', 'patients with mitochondrial myopathy', 'In cohorts of 8-13, 53 participants']","['semi-synthetic triterpenoid omaveloxolone', 'Omaveloxolone', 'placebo', 'omaveloxolone treatment vs placebo', 'omaveloxolone']","['blood lactate', 'heart rate', 'change peak exercise workload', 'peak workload or 6MWT', 'safety and efficacy', 'Adverse events', 'Safety and efficacy', 'mitochondrial function and submaximal exercise tolerance', 'peak cycling exercise workload (primary), in 6-minute walk test (6MWT) distance (secondary), and in submaximal exercise heart rate and plasma lactate (exploratory']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162670', 'cui_str': 'Mitochondrial Myopathies'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",53.0,0.657231,No differences in peak workload or 6MWT were observed at week 12 with omaveloxolone treatment vs placebo for all omaveloxolone dose groups.,"[{'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Madsen', 'Affiliation': ""From Copenhagen Neuromuscular Center (K.L.M., A.E.B., J.V.), Rigshospitalet, University of Copenhagen, Denmark; Akron Children's Hospital (B.H.C.), OH; Mitochondrial Medicine Frontier Program, Department of Pediatrics (M.J.F., C.C.M., Z.Z.C.), The Children's Hospital of Philadelphia; University of Pennsylvania Perelman School of Medicine (M.J.F., Z.Z.C.), Philadelphia; Reata Pharmaceuticals (A. Goldsberry, C.M., M.O.), Irving, TX; University of Pittsburgh School of Medicine (A. Goldstein, J.V.), Children's Hospital of Pittsburgh of UPMC, PA; Genetics Unit (A.K.), Massachusetts General, Boston; University of Texas Medical School (M.K.K.); Baylor College of Medicine (F.S.); Texas Children's Hospital (F.S.), Houston; BCM-CUHK Center of Medical Genetics (F.S.), Prince of Wales Hospital, ShaTin, New Territories, Hong Kong; University of California Los Angeles (P.B.S.); and University of Texas Southwestern Medical Center and Neuromuscular Center (R.G.H.), Institute for Exercise & Environmental Medicine, Dallas. karen.lindhardt.madsen@regionh.dk.""}, {'ForeName': 'Astrid E', 'Initials': 'AE', 'LastName': 'Buch', 'Affiliation': ""From Copenhagen Neuromuscular Center (K.L.M., A.E.B., J.V.), Rigshospitalet, University of Copenhagen, Denmark; Akron Children's Hospital (B.H.C.), OH; Mitochondrial Medicine Frontier Program, Department of Pediatrics (M.J.F., C.C.M., Z.Z.C.), The Children's Hospital of Philadelphia; University of Pennsylvania Perelman School of Medicine (M.J.F., Z.Z.C.), Philadelphia; Reata Pharmaceuticals (A. Goldsberry, C.M., M.O.), Irving, TX; University of Pittsburgh School of Medicine (A. Goldstein, J.V.), Children's Hospital of Pittsburgh of UPMC, PA; Genetics Unit (A.K.), Massachusetts General, Boston; University of Texas Medical School (M.K.K.); Baylor College of Medicine (F.S.); Texas Children's Hospital (F.S.), Houston; BCM-CUHK Center of Medical Genetics (F.S.), Prince of Wales Hospital, ShaTin, New Territories, Hong Kong; University of California Los Angeles (P.B.S.); and University of Texas Southwestern Medical Center and Neuromuscular Center (R.G.H.), Institute for Exercise & Environmental Medicine, Dallas.""}, {'ForeName': 'Bruce H', 'Initials': 'BH', 'LastName': 'Cohen', 'Affiliation': ""From Copenhagen Neuromuscular Center (K.L.M., A.E.B., J.V.), Rigshospitalet, University of Copenhagen, Denmark; Akron Children's Hospital (B.H.C.), OH; Mitochondrial Medicine Frontier Program, Department of Pediatrics (M.J.F., C.C.M., Z.Z.C.), The Children's Hospital of Philadelphia; University of Pennsylvania Perelman School of Medicine (M.J.F., Z.Z.C.), Philadelphia; Reata Pharmaceuticals (A. Goldsberry, C.M., M.O.), Irving, TX; University of Pittsburgh School of Medicine (A. Goldstein, J.V.), Children's Hospital of Pittsburgh of UPMC, PA; Genetics Unit (A.K.), Massachusetts General, Boston; University of Texas Medical School (M.K.K.); Baylor College of Medicine (F.S.); Texas Children's Hospital (F.S.), Houston; BCM-CUHK Center of Medical Genetics (F.S.), Prince of Wales Hospital, ShaTin, New Territories, Hong Kong; University of California Los Angeles (P.B.S.); and University of Texas Southwestern Medical Center and Neuromuscular Center (R.G.H.), Institute for Exercise & Environmental Medicine, Dallas.""}, {'ForeName': 'Marni J', 'Initials': 'MJ', 'LastName': 'Falk', 'Affiliation': ""From Copenhagen Neuromuscular Center (K.L.M., A.E.B., J.V.), Rigshospitalet, University of Copenhagen, Denmark; Akron Children's Hospital (B.H.C.), OH; Mitochondrial Medicine Frontier Program, Department of Pediatrics (M.J.F., C.C.M., Z.Z.C.), The Children's Hospital of Philadelphia; University of Pennsylvania Perelman School of Medicine (M.J.F., Z.Z.C.), Philadelphia; Reata Pharmaceuticals (A. Goldsberry, C.M., M.O.), Irving, TX; University of Pittsburgh School of Medicine (A. Goldstein, J.V.), Children's Hospital of Pittsburgh of UPMC, PA; Genetics Unit (A.K.), Massachusetts General, Boston; University of Texas Medical School (M.K.K.); Baylor College of Medicine (F.S.); Texas Children's Hospital (F.S.), Houston; BCM-CUHK Center of Medical Genetics (F.S.), Prince of Wales Hospital, ShaTin, New Territories, Hong Kong; University of California Los Angeles (P.B.S.); and University of Texas Southwestern Medical Center and Neuromuscular Center (R.G.H.), Institute for Exercise & Environmental Medicine, Dallas.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Goldsberry', 'Affiliation': ""From Copenhagen Neuromuscular Center (K.L.M., A.E.B., J.V.), Rigshospitalet, University of Copenhagen, Denmark; Akron Children's Hospital (B.H.C.), OH; Mitochondrial Medicine Frontier Program, Department of Pediatrics (M.J.F., C.C.M., Z.Z.C.), The Children's Hospital of Philadelphia; University of Pennsylvania Perelman School of Medicine (M.J.F., Z.Z.C.), Philadelphia; Reata Pharmaceuticals (A. Goldsberry, C.M., M.O.), Irving, TX; University of Pittsburgh School of Medicine (A. Goldstein, J.V.), Children's Hospital of Pittsburgh of UPMC, PA; Genetics Unit (A.K.), Massachusetts General, Boston; University of Texas Medical School (M.K.K.); Baylor College of Medicine (F.S.); Texas Children's Hospital (F.S.), Houston; BCM-CUHK Center of Medical Genetics (F.S.), Prince of Wales Hospital, ShaTin, New Territories, Hong Kong; University of California Los Angeles (P.B.S.); and University of Texas Southwestern Medical Center and Neuromuscular Center (R.G.H.), Institute for Exercise & Environmental Medicine, Dallas.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Goldstein', 'Affiliation': ""From Copenhagen Neuromuscular Center (K.L.M., A.E.B., J.V.), Rigshospitalet, University of Copenhagen, Denmark; Akron Children's Hospital (B.H.C.), OH; Mitochondrial Medicine Frontier Program, Department of Pediatrics (M.J.F., C.C.M., Z.Z.C.), The Children's Hospital of Philadelphia; University of Pennsylvania Perelman School of Medicine (M.J.F., Z.Z.C.), Philadelphia; Reata Pharmaceuticals (A. Goldsberry, C.M., M.O.), Irving, TX; University of Pittsburgh School of Medicine (A. Goldstein, J.V.), Children's Hospital of Pittsburgh of UPMC, PA; Genetics Unit (A.K.), Massachusetts General, Boston; University of Texas Medical School (M.K.K.); Baylor College of Medicine (F.S.); Texas Children's Hospital (F.S.), Houston; BCM-CUHK Center of Medical Genetics (F.S.), Prince of Wales Hospital, ShaTin, New Territories, Hong Kong; University of California Los Angeles (P.B.S.); and University of Texas Southwestern Medical Center and Neuromuscular Center (R.G.H.), Institute for Exercise & Environmental Medicine, Dallas.""}, {'ForeName': 'Amel', 'Initials': 'A', 'LastName': 'Karaa', 'Affiliation': ""From Copenhagen Neuromuscular Center (K.L.M., A.E.B., J.V.), Rigshospitalet, University of Copenhagen, Denmark; Akron Children's Hospital (B.H.C.), OH; Mitochondrial Medicine Frontier Program, Department of Pediatrics (M.J.F., C.C.M., Z.Z.C.), The Children's Hospital of Philadelphia; University of Pennsylvania Perelman School of Medicine (M.J.F., Z.Z.C.), Philadelphia; Reata Pharmaceuticals (A. Goldsberry, C.M., M.O.), Irving, TX; University of Pittsburgh School of Medicine (A. Goldstein, J.V.), Children's Hospital of Pittsburgh of UPMC, PA; Genetics Unit (A.K.), Massachusetts General, Boston; University of Texas Medical School (M.K.K.); Baylor College of Medicine (F.S.); Texas Children's Hospital (F.S.), Houston; BCM-CUHK Center of Medical Genetics (F.S.), Prince of Wales Hospital, ShaTin, New Territories, Hong Kong; University of California Los Angeles (P.B.S.); and University of Texas Southwestern Medical Center and Neuromuscular Center (R.G.H.), Institute for Exercise & Environmental Medicine, Dallas.""}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Koenig', 'Affiliation': ""From Copenhagen Neuromuscular Center (K.L.M., A.E.B., J.V.), Rigshospitalet, University of Copenhagen, Denmark; Akron Children's Hospital (B.H.C.), OH; Mitochondrial Medicine Frontier Program, Department of Pediatrics (M.J.F., C.C.M., Z.Z.C.), The Children's Hospital of Philadelphia; University of Pennsylvania Perelman School of Medicine (M.J.F., Z.Z.C.), Philadelphia; Reata Pharmaceuticals (A. Goldsberry, C.M., M.O.), Irving, TX; University of Pittsburgh School of Medicine (A. Goldstein, J.V.), Children's Hospital of Pittsburgh of UPMC, PA; Genetics Unit (A.K.), Massachusetts General, Boston; University of Texas Medical School (M.K.K.); Baylor College of Medicine (F.S.); Texas Children's Hospital (F.S.), Houston; BCM-CUHK Center of Medical Genetics (F.S.), Prince of Wales Hospital, ShaTin, New Territories, Hong Kong; University of California Los Angeles (P.B.S.); and University of Texas Southwestern Medical Center and Neuromuscular Center (R.G.H.), Institute for Exercise & Environmental Medicine, Dallas.""}, {'ForeName': 'Colleen C', 'Initials': 'CC', 'LastName': 'Muraresku', 'Affiliation': ""From Copenhagen Neuromuscular Center (K.L.M., A.E.B., J.V.), Rigshospitalet, University of Copenhagen, Denmark; Akron Children's Hospital (B.H.C.), OH; Mitochondrial Medicine Frontier Program, Department of Pediatrics (M.J.F., C.C.M., Z.Z.C.), The Children's Hospital of Philadelphia; University of Pennsylvania Perelman School of Medicine (M.J.F., Z.Z.C.), Philadelphia; Reata Pharmaceuticals (A. Goldsberry, C.M., M.O.), Irving, TX; University of Pittsburgh School of Medicine (A. Goldstein, J.V.), Children's Hospital of Pittsburgh of UPMC, PA; Genetics Unit (A.K.), Massachusetts General, Boston; University of Texas Medical School (M.K.K.); Baylor College of Medicine (F.S.); Texas Children's Hospital (F.S.), Houston; BCM-CUHK Center of Medical Genetics (F.S.), Prince of Wales Hospital, ShaTin, New Territories, Hong Kong; University of California Los Angeles (P.B.S.); and University of Texas Southwestern Medical Center and Neuromuscular Center (R.G.H.), Institute for Exercise & Environmental Medicine, Dallas.""}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Meyer', 'Affiliation': ""From Copenhagen Neuromuscular Center (K.L.M., A.E.B., J.V.), Rigshospitalet, University of Copenhagen, Denmark; Akron Children's Hospital (B.H.C.), OH; Mitochondrial Medicine Frontier Program, Department of Pediatrics (M.J.F., C.C.M., Z.Z.C.), The Children's Hospital of Philadelphia; University of Pennsylvania Perelman School of Medicine (M.J.F., Z.Z.C.), Philadelphia; Reata Pharmaceuticals (A. Goldsberry, C.M., M.O.), Irving, TX; University of Pittsburgh School of Medicine (A. Goldstein, J.V.), Children's Hospital of Pittsburgh of UPMC, PA; Genetics Unit (A.K.), Massachusetts General, Boston; University of Texas Medical School (M.K.K.); Baylor College of Medicine (F.S.); Texas Children's Hospital (F.S.), Houston; BCM-CUHK Center of Medical Genetics (F.S.), Prince of Wales Hospital, ShaTin, New Territories, Hong Kong; University of California Los Angeles (P.B.S.); and University of Texas Southwestern Medical Center and Neuromuscular Center (R.G.H.), Institute for Exercise & Environmental Medicine, Dallas.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': ""O'Grady"", 'Affiliation': ""From Copenhagen Neuromuscular Center (K.L.M., A.E.B., J.V.), Rigshospitalet, University of Copenhagen, Denmark; Akron Children's Hospital (B.H.C.), OH; Mitochondrial Medicine Frontier Program, Department of Pediatrics (M.J.F., C.C.M., Z.Z.C.), The Children's Hospital of Philadelphia; University of Pennsylvania Perelman School of Medicine (M.J.F., Z.Z.C.), Philadelphia; Reata Pharmaceuticals (A. Goldsberry, C.M., M.O.), Irving, TX; University of Pittsburgh School of Medicine (A. Goldstein, J.V.), Children's Hospital of Pittsburgh of UPMC, PA; Genetics Unit (A.K.), Massachusetts General, Boston; University of Texas Medical School (M.K.K.); Baylor College of Medicine (F.S.); Texas Children's Hospital (F.S.), Houston; BCM-CUHK Center of Medical Genetics (F.S.), Prince of Wales Hospital, ShaTin, New Territories, Hong Kong; University of California Los Angeles (P.B.S.); and University of Texas Southwestern Medical Center and Neuromuscular Center (R.G.H.), Institute for Exercise & Environmental Medicine, Dallas.""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Scaglia', 'Affiliation': ""From Copenhagen Neuromuscular Center (K.L.M., A.E.B., J.V.), Rigshospitalet, University of Copenhagen, Denmark; Akron Children's Hospital (B.H.C.), OH; Mitochondrial Medicine Frontier Program, Department of Pediatrics (M.J.F., C.C.M., Z.Z.C.), The Children's Hospital of Philadelphia; University of Pennsylvania Perelman School of Medicine (M.J.F., Z.Z.C.), Philadelphia; Reata Pharmaceuticals (A. Goldsberry, C.M., M.O.), Irving, TX; University of Pittsburgh School of Medicine (A. Goldstein, J.V.), Children's Hospital of Pittsburgh of UPMC, PA; Genetics Unit (A.K.), Massachusetts General, Boston; University of Texas Medical School (M.K.K.); Baylor College of Medicine (F.S.); Texas Children's Hospital (F.S.), Houston; BCM-CUHK Center of Medical Genetics (F.S.), Prince of Wales Hospital, ShaTin, New Territories, Hong Kong; University of California Los Angeles (P.B.S.); and University of Texas Southwestern Medical Center and Neuromuscular Center (R.G.H.), Institute for Exercise & Environmental Medicine, Dallas.""}, {'ForeName': 'Perry B', 'Initials': 'PB', 'LastName': 'Shieh', 'Affiliation': ""From Copenhagen Neuromuscular Center (K.L.M., A.E.B., J.V.), Rigshospitalet, University of Copenhagen, Denmark; Akron Children's Hospital (B.H.C.), OH; Mitochondrial Medicine Frontier Program, Department of Pediatrics (M.J.F., C.C.M., Z.Z.C.), The Children's Hospital of Philadelphia; University of Pennsylvania Perelman School of Medicine (M.J.F., Z.Z.C.), Philadelphia; Reata Pharmaceuticals (A. Goldsberry, C.M., M.O.), Irving, TX; University of Pittsburgh School of Medicine (A. Goldstein, J.V.), Children's Hospital of Pittsburgh of UPMC, PA; Genetics Unit (A.K.), Massachusetts General, Boston; University of Texas Medical School (M.K.K.); Baylor College of Medicine (F.S.); Texas Children's Hospital (F.S.), Houston; BCM-CUHK Center of Medical Genetics (F.S.), Prince of Wales Hospital, ShaTin, New Territories, Hong Kong; University of California Los Angeles (P.B.S.); and University of Texas Southwestern Medical Center and Neuromuscular Center (R.G.H.), Institute for Exercise & Environmental Medicine, Dallas.""}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Vockley', 'Affiliation': ""From Copenhagen Neuromuscular Center (K.L.M., A.E.B., J.V.), Rigshospitalet, University of Copenhagen, Denmark; Akron Children's Hospital (B.H.C.), OH; Mitochondrial Medicine Frontier Program, Department of Pediatrics (M.J.F., C.C.M., Z.Z.C.), The Children's Hospital of Philadelphia; University of Pennsylvania Perelman School of Medicine (M.J.F., Z.Z.C.), Philadelphia; Reata Pharmaceuticals (A. Goldsberry, C.M., M.O.), Irving, TX; University of Pittsburgh School of Medicine (A. Goldstein, J.V.), Children's Hospital of Pittsburgh of UPMC, PA; Genetics Unit (A.K.), Massachusetts General, Boston; University of Texas Medical School (M.K.K.); Baylor College of Medicine (F.S.); Texas Children's Hospital (F.S.), Houston; BCM-CUHK Center of Medical Genetics (F.S.), Prince of Wales Hospital, ShaTin, New Territories, Hong Kong; University of California Los Angeles (P.B.S.); and University of Texas Southwestern Medical Center and Neuromuscular Center (R.G.H.), Institute for Exercise & Environmental Medicine, Dallas.""}, {'ForeName': 'Zarazuela', 'Initials': 'Z', 'LastName': 'Zolkipli-Cunningham', 'Affiliation': ""From Copenhagen Neuromuscular Center (K.L.M., A.E.B., J.V.), Rigshospitalet, University of Copenhagen, Denmark; Akron Children's Hospital (B.H.C.), OH; Mitochondrial Medicine Frontier Program, Department of Pediatrics (M.J.F., C.C.M., Z.Z.C.), The Children's Hospital of Philadelphia; University of Pennsylvania Perelman School of Medicine (M.J.F., Z.Z.C.), Philadelphia; Reata Pharmaceuticals (A. Goldsberry, C.M., M.O.), Irving, TX; University of Pittsburgh School of Medicine (A. Goldstein, J.V.), Children's Hospital of Pittsburgh of UPMC, PA; Genetics Unit (A.K.), Massachusetts General, Boston; University of Texas Medical School (M.K.K.); Baylor College of Medicine (F.S.); Texas Children's Hospital (F.S.), Houston; BCM-CUHK Center of Medical Genetics (F.S.), Prince of Wales Hospital, ShaTin, New Territories, Hong Kong; University of California Los Angeles (P.B.S.); and University of Texas Southwestern Medical Center and Neuromuscular Center (R.G.H.), Institute for Exercise & Environmental Medicine, Dallas.""}, {'ForeName': 'Ronald G', 'Initials': 'RG', 'LastName': 'Haller', 'Affiliation': ""From Copenhagen Neuromuscular Center (K.L.M., A.E.B., J.V.), Rigshospitalet, University of Copenhagen, Denmark; Akron Children's Hospital (B.H.C.), OH; Mitochondrial Medicine Frontier Program, Department of Pediatrics (M.J.F., C.C.M., Z.Z.C.), The Children's Hospital of Philadelphia; University of Pennsylvania Perelman School of Medicine (M.J.F., Z.Z.C.), Philadelphia; Reata Pharmaceuticals (A. Goldsberry, C.M., M.O.), Irving, TX; University of Pittsburgh School of Medicine (A. Goldstein, J.V.), Children's Hospital of Pittsburgh of UPMC, PA; Genetics Unit (A.K.), Massachusetts General, Boston; University of Texas Medical School (M.K.K.); Baylor College of Medicine (F.S.); Texas Children's Hospital (F.S.), Houston; BCM-CUHK Center of Medical Genetics (F.S.), Prince of Wales Hospital, ShaTin, New Territories, Hong Kong; University of California Los Angeles (P.B.S.); and University of Texas Southwestern Medical Center and Neuromuscular Center (R.G.H.), Institute for Exercise & Environmental Medicine, Dallas.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vissing', 'Affiliation': ""From Copenhagen Neuromuscular Center (K.L.M., A.E.B., J.V.), Rigshospitalet, University of Copenhagen, Denmark; Akron Children's Hospital (B.H.C.), OH; Mitochondrial Medicine Frontier Program, Department of Pediatrics (M.J.F., C.C.M., Z.Z.C.), The Children's Hospital of Philadelphia; University of Pennsylvania Perelman School of Medicine (M.J.F., Z.Z.C.), Philadelphia; Reata Pharmaceuticals (A. Goldsberry, C.M., M.O.), Irving, TX; University of Pittsburgh School of Medicine (A. Goldstein, J.V.), Children's Hospital of Pittsburgh of UPMC, PA; Genetics Unit (A.K.), Massachusetts General, Boston; University of Texas Medical School (M.K.K.); Baylor College of Medicine (F.S.); Texas Children's Hospital (F.S.), Houston; BCM-CUHK Center of Medical Genetics (F.S.), Prince of Wales Hospital, ShaTin, New Territories, Hong Kong; University of California Los Angeles (P.B.S.); and University of Texas Southwestern Medical Center and Neuromuscular Center (R.G.H.), Institute for Exercise & Environmental Medicine, Dallas.""}]",Neurology,['10.1212/WNL.0000000000008861']
1937,32065303,Differential effects of BCG vaccine on immune responses induced by vi polysaccharide typhoid fever vaccination: an explorative randomized trial.,"The Vi polysaccharide typhoid fever vaccine (TFV) provides incomplete protection against typhoid fever. BCG, the vaccine against tuberculosis, can potentiate immune responses to other vaccines through induction of trained innate immunity and heterologous adaptive immunity. We performed an explorative, randomized, noncontrolled open trial to investigate whether BCG vaccination increases humoral and cellular response to TFV and whether BCG and TFV modulate nonspecific immune responses. Thirty volunteers were randomized to receive either TFV alone or BCG followed by TFV after 2 weeks. Ex vivo leukocyte responses and anti-Vi IgG antibody titers were measured 2 weeks and 3 months after TFV. BCG administration prior to TFV vaccination did not increase specific humoral or cellular immune responses to Salmonella typhi. TFV vaccination decreased pro-inflammatory responses to non-related stimuli. This effect was counteracted by prior BCG administration, which also led to decreased IL-10 and increased IL-22 responses to non-related stimuli. In an in vitro model of trained immunity TFV led to immunotolerance, which was partially reversed by BCG-induced trained immunity. BCG does not modulate adaptive immune responses to TFV but partially prevents inhibition of innate immune responses induced by TFV. Nonspecific effects of vaccines to unrelated microbial stimuli must be considered in the evaluation of their biological effects (ClinicalTrials.gov NCT02175420).",2020,"This effect was counteracted by prior BCG administration, which also led to decreased IL-10 and increased IL-22 responses to non-related stimuli.","['Thirty volunteers', 'vi polysaccharide typhoid fever vaccination']","['BCG', 'TFV alone or BCG', 'BCG vaccine', 'Vi polysaccharide typhoid fever vaccine (TFV', 'TFV vaccination', 'BCG vaccination']","['IL-10 and increased IL-22 responses', 'specific humoral or cellular immune responses', 'Ex vivo leukocyte responses and anti-Vi IgG antibody titers']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0085957', 'cui_str': 'BCG'}, {'cui': 'C0004886', 'cui_str': 'BCG Vaccine'}, {'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0199804', 'cui_str': 'BCG immunization'}]","[{'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0961814', 'cui_str': 'interleukin-22'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1817908', 'cui_str': 'Cellular Immune Response'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}]",30.0,0.197746,"This effect was counteracted by prior BCG administration, which also led to decreased IL-10 and increased IL-22 responses to non-related stimuli.","[{'ForeName': 'Bastiaan A', 'Initials': 'BA', 'LastName': 'Blok', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases (RCI), Radboud University Medical Center, 6526, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Rob J W', 'Initials': 'RJW', 'LastName': 'Arts', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases (RCI), Radboud University Medical Center, 6526, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Reinout', 'Initials': 'R', 'LastName': 'van Crevel', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases (RCI), Radboud University Medical Center, 6526, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Aaby', 'Affiliation': 'Research Center for Vitamins and Vaccines, Bandim Health Project, Statens Serum Institut, DK-2300, Copenhagen, Denmark.'}, {'ForeName': 'Leo A B', 'Initials': 'LAB', 'LastName': 'Joosten', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases (RCI), Radboud University Medical Center, 6526, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Christine S', 'Initials': 'CS', 'LastName': 'Benn', 'Affiliation': 'Research Center for Vitamins and Vaccines, Bandim Health Project, Statens Serum Institut, DK-2300, Copenhagen, Denmark.'}, {'ForeName': 'Mihai G', 'Initials': 'MG', 'LastName': 'Netea', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases (RCI), Radboud University Medical Center, 6526, GA, Nijmegen, The Netherlands. mihai.netea@radboudumc.nl.'}]",European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology,['10.1007/s10096-020-03813-y']
1938,31505907,"Ten-Day Concomitant, 10-Day Sequential, and 7-Day Triple Therapy as First-Line Treatment for  Helicobacter pylori  Infection: A Nationwide Randomized Trial in Korea.","Background/Aims


This nationwide, multicenter prospective randomized controlled trial aimed to compare the efficacy and safety of 10-day concomitant therapy (CT) and 10-day sequential therapy (ST) with 7-day clarithromycin-containing triple therapy (TT) as first-line treatment for  Helicobacter pylori  infection in the Korean population.
Methods


Patients with  H. pylori  infection were assigned randomly to 7d-TT (lansoprazole 30 mg, amoxicillin 1 g, and clarithromycin 500 mg twice daily for 7 days), 10d-ST (lansoprazole 30 mg and amoxicillin 1 g twice daily for the first 5 days, followed by lansoprazole 30 mg, clarithromycin 500 mg, and metronidazole 500 mg twice daily for the remaining 5 days), or 10d-CT (lansoprazole 30 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg twice daily for 10 days). The primary endpoint was eradication rate by intention-to-treat (ITT) and per-protocol (PP) analyses.
Results


A total of 1,141 patients were included. The 10d-CT protocol achieved a markedly higher eradication rate than the 7d-TT protocol in both the ITT (81.2% vs 63.9%) and PP analyses (90.6% vs 71.4%). The eradication rate of the 10d-ST protocol was superior to that of the 7d-TT protocol (76.3% vs 63.9%, ITT analysis; 85.0% vs 71.4%, PP analysis). No significant differences in adherence or serious side effects were found among the three treatment arms.
Conclusions


The 10d-CT and 10d-ST regimens were superior to the 7d-TT regimen as standard first-line treatment in Korea.",2019,The 10d-CT protocol achieved a markedly higher eradication rate than the 7d-TT protocol in both the ITT (81.2% vs 63.9%) and PP analyses (90.6% vs 71.4%).,"['A total of 1,141 patients were included', 'Methods\n\n\nPatients with  H. pylori  infection', 'Helicobacter pylori  infection in the Korean population', 'Helicobacter pylori  Infection']","['10-day concomitant therapy (CT) and 10-day sequential therapy (ST) with 7-day clarithromycin-containing triple therapy (TT', 'lansoprazole 30 mg, clarithromycin 500 mg, and metronidazole 500 mg twice daily for the remaining 5 days), or 10d-CT (lansoprazole 30 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole', 'TT (lansoprazole 30 mg, amoxicillin 1 g, and clarithromycin 500 mg twice daily for 7 days), 10d-ST (lansoprazole 30 mg and amoxicillin']","['eradication rate by intention-to-treat (ITT) and per-protocol (PP) analyses', 'efficacy and safety', 'adherence or serious side effects', 'PP analyses', 'eradication rate']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C1602204', 'cui_str': 'lansoprazole 30 MG [Prevacid]'}, {'cui': 'C0984982', 'cui_str': 'Clarithromycin 500 MG'}, {'cui': 'C0992611', 'cui_str': 'Metronidazole 500 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",1141.0,0.0379561,The 10d-CT protocol achieved a markedly higher eradication rate than the 7d-TT protocol in both the ITT (81.2% vs 63.9%) and PP analyses (90.6% vs 71.4%).,"[{'ForeName': 'Beom Jin', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyuk', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Yong Chan', 'Initials': 'YC', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seong Woo', 'Initials': 'SW', 'LastName': 'Jeon', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea.'}, {'ForeName': 'Gwang Ha', 'Initials': 'GH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Pusan National University School of Medicine, Busan, Korea.'}, {'ForeName': 'Hyun-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea.'}, {'ForeName': 'Jae Kyu', 'Initials': 'JK', 'LastName': 'Sung', 'Affiliation': 'Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Dong Ho', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Heung Up', 'Initials': 'HU', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Jeju National University School of Medicine, Jeju, Korea.'}, {'ForeName': 'Moo In', 'Initials': 'MI', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Kosin University Gospel Hospital, Kosin University College of Medicine, Busan, Korea.'}, {'ForeName': 'Il Ju', 'Initials': 'IJ', 'LastName': 'Choi', 'Affiliation': 'Center for Gastric Cancer, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Soon Man', 'Initials': 'SM', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea.'}, {'ForeName': 'Sang Wook', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Chonbuk National University Hospital, Chonbuk National University Medical School, Jeonju, Korea.'}, {'ForeName': 'Gwang Ho', 'Initials': 'GH', 'LastName': 'Baik', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.'}, {'ForeName': 'Ju Yup', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Jin Il', 'Initials': 'JI', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yeouido St. Mary Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Sang Gyun', 'Initials': 'SG', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jayoun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Medical Research Collaborating Center, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Joongyup', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Prevention and Management, Inha University Hospital, Inha University School of Medicine, Incheon, Korea.'}, {'ForeName': 'Jae Gyu', 'Initials': 'JG', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jae J', 'Initials': 'JJ', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gut and liver,['10.5009/gnl19136']
1939,31365952,A study on treatment sensitivity of ecological momentary assessment in obsessive-compulsive disorder.,"As part of a larger clinical trial, this ecological momentary assessment (EMA) study pursued the main goal of demonstrating that the EMA method is sensitive to treatment effects of detached mindfulness and cognitive restructuring for obsessive-compulsive disorder (OCD). A second goal was to provide a descriptive analysis of OCD symptoms and influencing factors in participants' everyday lives. Thirty-nine participants were included in the final analyses. EMA sampling involved a smartphone and comprised 4 days with 10 random prompts per day both before (Pre-Treatment EMA) and after the completion of a 2-week clinical intervention of either detached mindfulness or cognitive restructuring (Post-Treatment EMA) that participants had been randomly allocated to. The EMA questionnaire included items on the frequency of obsessions, subjective burden due to obsessions, perceived current stress, emotions, and on the frequency of compulsions and other dysfunctional behaviors. Descriptive Pre-Treatment EMA results highlight the importance of compulsions and emotional states of tension/discomfort in OCD. Pre-Post comparisons showed a significant reduction of avoidance behavior, obsessions, and burden due to obsessions, with a nonsignificant trend also indicating a reduction of compulsions. There was no pre to post effect concerning emotions. This study adds to the existing research on OCD symptoms and offers further evidence in confirmation of established theoretical models of OCD. Also, our results can be taken as evidence for treatment sensitivity of the EMA method in OCD. Further research is needed to replicate, broaden, and generalize our results.",2019,There was no pre to post effect concerning emotions.,"['obsessive-compulsive disorder (OCD', ""participants' everyday lives"", 'Thirty-nine participants were included in the final analyses', 'obsessive-compulsive disorder']",['detached mindfulness or cognitive restructuring (Post-Treatment EMA'],"['frequency of obsessions, subjective burden due to obsessions, perceived current stress, emotions, and on the frequency of compulsions and other dysfunctional behaviors', 'avoidance behavior, obsessions, and burden due to obsessions']","[{'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150173', 'cui_str': 'Cognitive restructuring (regime/therapy)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0268596', 'cui_str': 'Glutaric Acidemia, Type 2'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0233697', 'cui_str': 'Obsessions'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0600104', 'cui_str': 'Compulsive Behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0178494', 'cui_str': 'Avoidance Behavior'}]",39.0,0.035255,There was no pre to post effect concerning emotions.,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rupp', 'Affiliation': 'Institute of Psychology, Westfälische Wilhelms-University Münster, Münster, Germany.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Falke', 'Affiliation': 'Institute of Psychology, Westfälische Wilhelms-University Münster, Münster, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Gühne', 'Affiliation': 'Department of Statistics, TU Dortmund University, Dortmund, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Doebler', 'Affiliation': 'Department of Statistics, TU Dortmund University, Dortmund, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Andor', 'Affiliation': 'Christoph-Dornier-Stiftung, Münster, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Buhlmann', 'Affiliation': 'Institute of Psychology, Westfälische Wilhelms-University Münster, Münster, Germany.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2392']
1940,31325110,Long-Term Effect of Immediate Versus Delayed Fingolimod Treatment in Young Adult Patients with Relapsing-Remitting Multiple Sclerosis: Pooled Analysis from the FREEDOMS/FREEDOMS II Trials.,"INTRODUCTION


Fingolimod has demonstrated clinical and MRI benefits versus placebo/interferon β-1a in young adults with multiple sclerosis (MS). Here we report the long-term effects of fingolimod 0.5 mg on clinical and MRI outcomes in young adults with MS aged ≤ 30 years followed up for up to 8 years (96 months).
METHODS


This post hoc analysis of pooled FREEDOMS/FREEDOMS II studies included patients who either received fingolimod 0.5 mg from randomization (immediate; N = 163) or switched from placebo to fingolimod at month (M) 24 (delayed; N = 147). The 6-month confirmed disability improvement [6m-CDI: based on Expanded Disability Status Scale (EDSS)], 6m-CDI-plus (6m-CDI+; EDSS, 9-Hole Peg Test, Timed 25-Foot Walk Test), 6-month confirmed disability progression (6m-CDP), time to EDSS score ≥ 4, annualized relapse rates (ARRs), new/newly enlarging T2 (neT2) lesions, and annual rate of brain volume loss (BVL) were analyzed from baseline to M24, M48, and M96. Cox regression and negative binomial regression models were used to analyze measured outcomes.
RESULTS


At baseline, more than two-thirds of young adult patients were treatment naïve, had more than two relapses in the previous 2 years, and EDSS score < 2. From M0 to M96, a significantly higher proportion of young adult patients in the immediate group (vs. delayed group) achieved 6m-CDI (58.2% vs. 30.5%, p = 0.0206) and 6m-CDI+ (70.6% vs. 42.3%, p = 0.0149); significantly fewer patients reached 6m-CDP (20.1% vs. 34.7%, p = 0.0058) and EDSS ≥ 4 (24.1% vs. 34.1%, p = 0.0041). Up to M96, young adults in the immediate versus delayed group had lower ARRs (0.16 vs. 0.38, p < 0.0001) and a higher proportion of patients were free of neT2 lesions at M48 (31.0% vs. 5.0%, p = 0.0011).
CONCLUSION


In young adult patients with MS, immediate versus delayed fingolimod treatment was associated with improved disease outcomes and greater long-term benefits in both disease activity and disability progression.
FUNDING


Novartis Pharma AG.",2019,"In young adult patients with MS, immediate versus delayed fingolimod treatment was associated with improved disease outcomes and greater long-term benefits in both disease activity and disability progression.
","['young adults with MS aged\u2009≤\u200930\xa0years followed up for up to 8\xa0years (96\xa0months', 'young adults with multiple sclerosis (MS', 'Young Adult Patients with Relapsing-Remitting Multiple Sclerosis', 'II studies included patients who either received']","['Immediate Versus Delayed Fingolimod Treatment', 'fingolimod', 'placebo/interferon β-1a', 'fingolimod 0.5\xa0mg from randomization (immediate; N\u2009=\u2009163) or switched from placebo']","['Expanded Disability Status Scale (EDSS)], 6m-CDI-plus (6m-CDI+; EDSS, 9-Hole', '6m-CDI', 'Peg Test, Timed 25-Foot Walk Test), 6-month confirmed disability progression (6m-CDP), time to EDSS score\u2009≥\u20094, annualized relapse rates (ARRs), new/newly enlarging T2 (neT2) lesions, and annual rate of brain volume loss (BVL', 'disease outcomes and greater long-term benefits in both disease activity and disability progression', 'lower ARRs', 'clinical and MRI outcomes']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751967', 'cui_str': 'Multiple Sclerosis, Relapsing-Remitting'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C2938759', 'cui_str': 'fingolimod 0.5 MG'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0010724', 'cui_str': 'CDP'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0442800', 'cui_str': 'Enlarged (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]",,0.0317428,"In young adult patients with MS, immediate versus delayed fingolimod treatment was associated with improved disease outcomes and greater long-term benefits in both disease activity and disability progression.
","[{'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Ghezzi', 'Affiliation': 'Centro Studi Sclerosi Multipla, Gallarate, Italy. angelo.ghezzi@asst-valleolona.it.'}, {'ForeName': 'Tanuja', 'Initials': 'T', 'LastName': 'Chitnis', 'Affiliation': 'Partners Pediatric Multiple Sclerosis Centre, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Annik', 'Initials': 'A', 'LastName': 'K-Laflamme', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Meinert', 'Affiliation': 'DATAMAP GmbH, Freiburg, Germany.'}, {'ForeName': 'Dieter A', 'Initials': 'DA', 'LastName': 'Häring', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pohl', 'Affiliation': ""Division of Neurology, Children's Hospital of Eastern Ontario, Ottawa, ON, Canada.""}]",Neurology and therapy,['10.1007/s40120-019-0146-z']
1941,31694978,Weight Loss and Illness Severity in Adolescents With Atypical Anorexia Nervosa.,"BACKGROUND


Lower weight has historically been equated with more severe illness in anorexia nervosa (AN). Reliance on admission weight to guide clinical concern is challenged by the rise in patients with atypical anorexia nervosa (AAN) requiring hospitalization at normal weight.
METHODS


We examined weight history and illness severity in 12- to 24-year-olds with AN ( n  = 66) and AAN ( n  = 50) in a randomized clinical trial, the Study of Refeeding to Optimize Inpatient Gains (www.clinicaltrials.gov; NCT02488109). Amount of weight loss was the difference between the highest historical percentage median BMI and admission; rate was the amount divided by duration (months). Unpaired  t  tests compared AAN and AN; multiple variable regressions examined associations between weight history variables and markers of illness severity at admission. Stepwise regression examined the explanatory value of weight and menstrual history on selected markers.
RESULTS


Participants were 16.5 ± 2.6 years old, and 91% were of female sex. Groups did not differ by weight history or admission heart rate (HR). Eating Disorder Examination Questionnaire global scores were higher in AAN (mean 3.80 [SD 1.66] vs mean 3.00 [SD 1.66];  P  = .02). Independent of admission weight, lower HR (β = -0.492 [confidence interval (CI) -0.883 to -0.100];  P  = .01) was associated with faster loss; lower serum phosphorus was associated with a greater amount (β = -0.005 [CI -0.010 to 0.000];  P  = .04) and longer duration (β = -0.011 [CI -0.017 to 0.005];  P  = .001). Weight and menstrual history explained 28% of the variance in HR and 36% of the variance in serum phosphorus.
CONCLUSIONS


Weight history was independently associated with markers of malnutrition in inpatients with restrictive eating disorders across a range of body weights and should be considered when assessing illness severity on hospital admission.",2019,Eating Disorder Examination Questionnaire global scores were higher in AAN (mean 3.80 [SD 1.66] vs mean 3.00 [SD 1.66];  P  = .02).,"['Participants were 16.5 ± 2.6 years old, and 91% were of female sex', 'patients with atypical anorexia nervosa (AAN) requiring hospitalization at normal weight', 'Adolescents With Atypical Anorexia Nervosa', '12- to 24-year-olds with AN ( n  = 66) and AAN ( n  = 50', 'inpatients with restrictive eating disorders']",[],"['weight history or admission heart rate (HR', 'Eating Disorder Examination Questionnaire global scores', 'Weight and menstrual history', 'weight history and illness severity', 'weight loss', 'Weight Loss and Illness Severity']","[{'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0338959', 'cui_str': 'Atypical anorexia nervosa (disorder)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}]",[],"[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C2959762', 'cui_str': 'Eating disorder examination questionnaire global score (observable entity)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0478223,Eating Disorder Examination Questionnaire global scores were higher in AAN (mean 3.80 [SD 1.66] vs mean 3.00 [SD 1.66];  P  = .02).,"[{'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Garber', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Departments of Pediatrics, andrea.garber@ucsf.edu.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Preventive and Restorative Dental Sciences.'}, {'ForeName': 'Erin C', 'Initials': 'EC', 'LastName': 'Accurso', 'Affiliation': 'Psychiatry, and.'}, {'ForeName': 'Sally H', 'Initials': 'SH', 'LastName': 'Adams', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Departments of Pediatrics.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Buckelew', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Departments of Pediatrics.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Kapphahn', 'Affiliation': 'Division of Adolescent Medicine, Department of Pediatrics, Stanford University, Stanford, California.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kreiter', 'Affiliation': 'Division of Adolescent Medicine, Department of Pediatrics, Stanford University, Stanford, California.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Le Grange', 'Affiliation': 'Psychiatry, and.'}, {'ForeName': 'Vanessa I', 'Initials': 'VI', 'LastName': 'Machen', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Departments of Pediatrics.'}, {'ForeName': 'Anna-Barbara', 'Initials': 'AB', 'LastName': 'Moscicki', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Department of Pediatrics, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Saffran', 'Affiliation': 'Division of Adolescent Medicine, Department of Pediatrics, Stanford University, Stanford, California.'}, {'ForeName': 'Allyson F', 'Initials': 'AF', 'LastName': 'Sy', 'Affiliation': 'Division of Adolescent Medicine, Department of Pediatrics, Stanford University, Stanford, California.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Wilson', 'Affiliation': 'Clinical Pharmacy, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Neville H', 'Initials': 'NH', 'LastName': 'Golden', 'Affiliation': 'Division of Adolescent Medicine, Department of Pediatrics, Stanford University, Stanford, California.'}]",Pediatrics,['10.1542/peds.2019-2339']
1942,31961463,Metformin plus megestrol acetate compared with megestrol acetate alone as fertility-sparing treatment in patients with atypical endometrial hyperplasia and well-differentiated endometrial cancer: a randomised controlled trial.,"OBJECTIVE


To assess the efficacy of metformin in megestrol acetate (MA)-based fertility-sparing treatment for patients with atypical endometrial hyperplasia (AEH) and endometrioid endometrial cancer (EEC).
DESIGN


A randomised, single-centre, open-label, controlled trial conducted between October 2013 and December 2017.
SETTING


Shanghai OBGYN Hospital of Fudan University, China.
POPULATION


A total of 150 patients (18-45 years old) with primary AEH or well-differentiated EEC were randomised into an MA group (n = 74) and an MA plus metformin group (n = 76).
METHODS


Patients with AEH or EEC were firstly stratified, then randomised to receive MA (160 mg orally, daily) or MA (160 mg orally, daily) plus metformin (500 mg orally, three times a day).
MAIN OUTCOMES AND MEASURES


The primary efficacy parameter was the cumulate complete response (CR) rate within 16 weeks of treatment (16w-CR rate); the secondary efficacy parameters were 30w-CR rate and adverse events.
RESULTS


The 16w-CR rate was higher in the metformin plus MA group than in the MA-only group (34.3 versus 20.7%, odds ratio [OR] 2.0, 95% confidence interval [CI] 0.89-4.51, P = 0.09) but the difference was more significant in 102 AEH patients (39.6 versus 20.4%, OR 2.56, 95% CI 1.06-6.21, P = 0.04). This effect of metformin was also significant in non-obese (51.4 versus 24.3%, OR 3.28, 95% CI 1.22-8.84, P = 0.02) and insulin-sensitive (54.8 versus 28.6%, OR 3.04, 95% CI 1.03-8.97, P = 0.04) subgroups of AEH women. No significant result was found in secondary endpoints.
CONCLUSION


As a fertility-sparing treatment, metformin plus MA was associated with a higher early CR rate compared with MA alone in AEH patients.
TWEETABLE ABSTRACT


For AEH patients, metformin plus MA might be a better fertility-sparing treatment to achieve a higher early CR rate compared with MA alone.",2020,"No significant result was found in secondary endpoints.
","['group (n=76', 'Totally 150 patients (18-45 years old) with primary AEH or well-differentiated EEC', 'patients with atypical endometrial hyperplasia (AEH) and endometrioid endometrial cancer (EEC', 'Patients with AEH or EEC', 'patients with atypical endometrial hyperplasia and well differentiated endometrial cancer', 'Shanghai OBGYN hospital of Fudan university, China', 'October 2013 and December 2017']","['Metformin plus Megestrol Acetate (MA', 'metformin', 'MA plus metformin', 'metformin plus MA', 'MA alone', 'megestrol acetate (MA)-based fertility-sparing treatment', 'MA']","['CR rate and adverse events', 'cumulate complete response (CR) rates', 'early CR rate', 'CR rate', 'insulin-sensitive']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated (qualifier value)'}, {'cui': 'C0600216', 'cui_str': 'Common Market'}, {'cui': 'C0349579', 'cui_str': 'Atypical Endometrial Hyperplasia'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0065879', 'cui_str': 'Megestrol Acetate'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}]",150.0,0.149445,"No significant result was found in secondary endpoints.
","[{'ForeName': 'B-Y', 'Initials': 'BY', 'LastName': 'Yang', 'Affiliation': 'Department of Gynaecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Gulinazi', 'Affiliation': 'Department of Gynaecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Department of Clinical Epidemiology, Obstetrics and Gynaecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'C-C', 'Initials': 'CC', 'LastName': 'Ning', 'Affiliation': 'Department of Gynaecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Y-L', 'Initials': 'YL', 'LastName': 'Cheng', 'Affiliation': 'Department of Gynaecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'W-W', 'Initials': 'WW', 'LastName': 'Shan', 'Affiliation': 'Department of Gynaecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'X-Z', 'Initials': 'XZ', 'LastName': 'Luo', 'Affiliation': 'Department of Gynaecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'H-W', 'Initials': 'HW', 'LastName': 'Zhang', 'Affiliation': 'Department of Cervical Diseases, Obstetrics and Gynaecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': 'Department of Pathology, Obstetrics and Gynaecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'F-H', 'Initials': 'FH', 'LastName': 'Ma', 'Affiliation': 'Department of Radiology, Obstetrics and Gynaecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Obstetrics and Gynaecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Sonography, Obstetrics and Gynaecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Shanghai JiAi Genetics and IVF Institute, Obstetrics and Gynaecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Guan', 'Affiliation': 'Department of Gynaecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'X-J', 'Initials': 'XJ', 'LastName': 'Chen', 'Affiliation': 'Department of Gynaecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16108']
1943,31634407,Long-term efficacy and safety of phrenic nerve stimulation for the treatment of central sleep apnea.,"STUDY OBJECTIVE


To evaluate long-term efficacy and safety of phrenic nerve stimulation (PNS) in patients with moderate-to-severe central sleep apnea (CSA) through 3 years of therapy.
METHODS


Patients in the remedē System Pivotal Trial were observed every 3 months after implant until US Food and Drug Administration approval. At the time of approval and study closure, all patients completed 24 months of follow-up; 33 patients had not reached the 36-month visit. Sleep metrics (polysomnography) and echocardiographic parameters are reported at baseline, 12, 18, and 24 months, in addition to available 36-month sleep results from polygraphy. Safety was assessed through 36 months; however, analysis focused through 24 months and available 36-month results are provided.
RESULTS


Patients were assessed at 24 (n = 109) and 36 (n = 60) months. Baseline characteristics included mean age 64 years, 91% male, and mean apnea-hypopnea index 47 events per hour. Sleep metrics (apnea-hypopnea index (AHI), central apnea index, arousal index, oxygen desaturation index, rapid eye movement sleep) remained improved through 24 and 36 months with continuous use of PNS therapy. At least 60% of patients in the treatment group achieved at least 50% reduction in AHI through 24 months. Serious adverse events (SAEs) related to the remedē System implant procedure, device, or therapy through 24 months were reported by 10% of patients, no unanticipated adverse device effects or deaths, and all events resolved. No additional related SAEs were reported between 24 and 36 months.
CONCLUSION


These data suggest beneficial effects of long-term PNS in patients with CSA appear to sustain through 36 months with no new safety concerns.
TRIAL REGISTRATION


NCT01816776.",2019,"No additional related SAEs were reported between 24 and 36 months.
","['patients with moderate-to-severe central sleep apnea (CSA) through 3 years of therapy', 'patients with CSA', 'Baseline characteristics included mean age 64 years, 91% male, and mean apnea-hypopnea index 47 events per hour', 'Patients in the remedē System Pivotal Trial', 'Patients were assessed at 24 (n = 109) and 36 (n = 60) months', 'central sleep apnea']","['phrenic nerve stimulation (PNS', 'phrenic nerve stimulation']","['Sleep metrics (apnea-hypopnea index (AHI), central apnea index, arousal index, oxygen desaturation index, rapid eye movement sleep', 'Sleep metrics (polysomnography) and echocardiographic parameters', 'Serious adverse events (SAEs', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C3887547', 'cui_str': 'Central sleep apnea syndrome (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0564385', 'cui_str': 'per hour'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0031774', 'cui_str': 'Phrenic Nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0520680', 'cui_str': 'Ondine Syndrome'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0037322', 'cui_str': 'Sleep, Fast-Wave'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0310684,"No additional related SAEs were reported between 24 and 36 months.
","[{'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Fox', 'Affiliation': 'Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Oldenburg', 'Affiliation': 'Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen.'}, {'ForeName': 'Shahrokh', 'Initials': 'S', 'LastName': 'Javaheri', 'Affiliation': 'Bethesda North Hospital, Cincinnati, OH.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Department of Heart Diseases, Medical University, Military Hospital, Wroclaw, Poland.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Augostini', 'Affiliation': 'Division of Cardiovascular Disease, Ohio State University, Columbus.'}, {'ForeName': 'Lee R', 'Initials': 'LR', 'LastName': 'Goldberg', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Stellbrink', 'Affiliation': 'Bielefeld Medical Center, Bielefeld, Germany.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Mckane', 'Affiliation': 'Respicardia, Inc., Minnetonka, MN.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Meyer', 'Affiliation': 'Respicardia, Inc., Minnetonka, MN.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Abraham', 'Affiliation': 'Division of Cardiovascular Disease, Ohio State University, Columbus.'}, {'ForeName': 'Maria Rosa', 'Initials': 'MR', 'LastName': 'Costanzo', 'Affiliation': 'Advocate Heart Institute, Naperville, IL.'}]",Sleep,['10.1093/sleep/zsz158']
1944,31830535,Rehabilitation of the upper arm early after stroke: Video games versus conventional rehabilitation. A randomized controlled trial.,"BACKGROUND


Few rehabilitation methods have proven their efficacy in increasing sensori-motor recovery and/or function of the upper limb (UL) after stroke. Video games (VGs) are promising tools in this indication.
OBJECTIVE


To compare UL rehabilitation by using VGs and conventional rehabilitation (CR) in patients with sub-acute stroke.
DESIGN


Single-blind, multicentric trial, with central randomization and stratification by center.
SETTING


Physical and rehabilitation medicine departments of 2 university hospitals.
PARTICIPANTS


Adults within 3 months after a first vascular cerebral accident, with UL Fugl Meyer Score (UL-FMS)<30/66 and without major cognitive impairment.
INTERVENTION


A 45-min additional session of conventional occupational therapy (OT) or a VG-based OT session as add-on therapy to usual rehabilitation programs, 5 days/week for 6 weeks.
MAIN OUTCOME MEASURES


Primary outcome: UL-FMS. Secondary outcome: Box and Block Test (BBT), Wolf Motor Function test (WMFT), Motor Activity Log (MAL), Barthel Index and quality of life (SF-36).
RESULTS


We included 51 patients (20 women) at a mean (SD) of 27.2 (19.4) days post-stroke (mean age 58 years [range 24-83]), 26 in the CR group and 25 in the VG group (23 in each group at 6-month follow-up). The mean duration of the additional rehabilitation session was similar in both groups: 29.3 (4.3) vs 28.0 (4.4) min in CR and VG groups. Shoulder pain occurred in 4 patients in the VG group versus 7 in the CR group. At day 45, gain in UL-FMS did not significantly differ between the groups (CR mean 17.8 [14.6] vs VG 24.1 [14.8]; P=0.10), whereas gain in BBT was doubled in the VG group (CR 7.4 [12.2] vs VG 15.7 [16.3]; P=0.02). At 6-month follow-up, the study was inconclusive about between-group differences in UL-FMS, BBT and other criteria. Post-hoc analysis showed that gains in UL-FMS or BBT were significantly higher in the VG than CR group for patients included within 30 days post-stroke.
CONCLUSION


In general, we cannot conclude that video gaming and conventional OT led to different long-term sensorimotor recovery of the UL after sub-acute stroke. However, when applied within the first month after stroke, video gaming was more efficient than conventional rehabilitation on both sensorimotor recovery and gross grasping function.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT01554449).",2019,"Post-hoc analysis showed that gains in UL-FMS or BBT were significantly higher in the VG than CR group for patients included within 30 days post-stroke.
","['51 patients (20 women) at a mean (SD) of 27.2 (19.4) days post-stroke (mean age 58 years', 'Physical and rehabilitation medicine departments of 2 university hospitals', 'Adults within 3 months after a first vascular cerebral accident, with UL Fugl Meyer Score (UL-FMS)<30/66 and without major cognitive impairment', 'Rehabilitation of the upper arm early after stroke', 'patients with sub-acute stroke']","['conventional occupational therapy (OT) or a VG-based OT session', 'UL rehabilitation by using VGs and conventional rehabilitation (CR', 'Video games versus conventional rehabilitation', 'Video games (VGs']","['BBT), Wolf Motor Function test (WMFT), Motor Activity Log (MAL), Barthel Index and quality of life (SF-36', 'Box and Block Test', 'gain in UL-FMS', 'gains in UL-FMS or BBT', 'mean duration of the additional rehabilitation session', 'gain in BBT', 'Shoulder pain', 'UL-FMS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4709305', 'cui_str': '19.4 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0031813', 'cui_str': 'Physiatrics'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1961149', 'cui_str': 'Accidental physical contact (event)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0446516', 'cui_str': 'Brachiums'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0325001', 'cui_str': 'Wolves'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0034380'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}]",51.0,0.139946,"Post-hoc analysis showed that gains in UL-FMS or BBT were significantly higher in the VG than CR group for patients included within 30 days post-stroke.
","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Laffont', 'Affiliation': 'PRM Department, University of Montpellier, Hôpital Lapeyronie, Montpellier University Hospital, 191, boulevard du Doyen-Gaston-Giraud, 34291 Montpellier cedex 05, France; IFRH, Euromov, University of Montpellier, Montpellier, France. Electronic address: i-laffont@chu-montpellier.fr.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Froger', 'Affiliation': 'IFRH, Euromov, University of Montpellier, Montpellier, France; PRM Department, University of Montpellier, Nimes University Hospital, Grau du Roi, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Jourdan', 'Affiliation': 'PRM Department, University of Montpellier, Hôpital Lapeyronie, Montpellier University Hospital, 191, boulevard du Doyen-Gaston-Giraud, 34291 Montpellier cedex 05, France; IFRH, Euromov, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Karima', 'Initials': 'K', 'LastName': 'Bakhti', 'Affiliation': 'PRM Department, University of Montpellier, Hôpital Lapeyronie, Montpellier University Hospital, 191, boulevard du Doyen-Gaston-Giraud, 34291 Montpellier cedex 05, France; IFRH, Euromov, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Liesjet E H', 'Initials': 'LEH', 'LastName': 'van Dokkum', 'Affiliation': 'Neuro Imagery Department, University of Montpellier, Montpellier University Hospital, Montpellier, France.'}, {'ForeName': 'Abdelkader', 'Initials': 'A', 'LastName': 'Gouaich', 'Affiliation': 'LIRMM, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Huei Yune', 'Initials': 'HY', 'LastName': 'Bonnin', 'Affiliation': 'PRM Department, University of Montpellier, Nimes University Hospital, Grau du Roi, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Armingaud', 'Affiliation': 'PRM Department, University of Montpellier, Nimes University Hospital, Grau du Roi, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Jaussent', 'Affiliation': 'Inserm, Clinical Research and Epidemiology Unit, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Marie Christine', 'Initials': 'MC', 'LastName': 'Picot', 'Affiliation': 'Inserm, Clinical Research and Epidemiology Unit, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Le Bars', 'Affiliation': 'CNRS, L2C, University of Montpellier, Montpellier, France; Neuro Imagery Department, University of Montpellier, Montpellier University Hospital, Montpellier, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Dupeyron', 'Affiliation': 'IFRH, Euromov, University of Montpellier, Montpellier, France; PRM Department, University of Montpellier, Nimes University Hospital, Grau du Roi, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Arquizan', 'Affiliation': 'Neurology Department, University of Montpellier, Montpellier University Hospital, Montpellier, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Gelis', 'Affiliation': 'PRM Department, Propara Center, Montpellier, France; Epsylon, Paul Valery University, Montpellier, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Mottet', 'Affiliation': 'IFRH, Euromov, University of Montpellier, Montpellier, France.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2019.10.009']
1945,31356475,Lactated Ringer's Versus 4% Albumin on Lactated Ringer's in Early Sepsis Therapy in Cancer Patients: A Pilot Single-Center Randomized Trial.,"OBJECTIVE


To investigate the effects of the administration of 4% albumin on lactated Ringer's, when compared with lactated Ringer's alone, in the early phase of sepsis in cancer patients.
DESIGN


Single-center, randomized, double-blind, controlled-parallel trial.
SETTING


A tertiary care university cancer hospital.
PATIENTS


Cancer patients with severe sepsis or septic shock.
INTERVENTIONS


Between October 2014 and December 2016, patients were randomly assigned to receive either bolus of albumin in a lactated Ringer's solution or lactated Ringer's solution alone during the first 6 hours of fluid resuscitation after intensive care medicine (ICU) admission. Primary outcome was defined as death from any cause at 7 days. Secondary outcomes were defined as death from any cause within 28 days, change in Sequence Organ Failure Assessment scores from baseline to day 7, days alive and free of mechanical ventilation, days alive and free of vasopressor, renal replacement therapy during ICU stay, and length of ICU and hospital stay.
MEASUREMENTS AND MAIN RESULTS


A total of 360 patients were enrolled in the trial. At 7 days, 46 of 180 patients (26%) died in the albumin group and 40 of 180 (22%) died in the lactated Ringer's group (p = 0.5). At 28 days, 96 of 180 patients (53%) died in the albumin group and 83 of 180 (46%) died in the lactated Ringer's group (p = 0.2). No significant differences in secondary outcomes were observed.
CONCLUSIONS


Adding albumin to early standard resuscitation with lactated Ringer's in cancer patients with sepsis did not improve 7-day survival.",2019,Adding albumin to early standard resuscitation with lactated Ringer's in cancer patients with sepsis did not improve 7-day survival.,"['Cancer patients with severe sepsis or septic shock', 'A tertiary care university cancer hospital', 'Cancer Patients', 'Between October 2014 and December 2016, patients', 'cancer patients with sepsis', '360 patients were enrolled in the trial', 'cancer patients']","[""Lactated Ringer's"", ""lactated Ringer's"", ""lactated Ringer's solution or lactated Ringer's solution alone"", ""Lactated Ringer's Versus 4% Albumin"", 'bolus of albumin', ""lactated Ringer's alone"", '4% albumin']","['death from any cause within 28 days, change in Sequence Organ Failure Assessment scores from baseline to day 7, days alive and free of mechanical ventilation, days alive and free of vasopressor, renal replacement therapy during ICU stay, and length of ICU and hospital stay', '7-day survival', 'death from any cause at 7 days']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1719672', 'cui_str': 'Severe Sepsis'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0019999', 'cui_str': 'Hospitals, Cancer'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}]","[{'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction (disorder)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",360.0,0.565631,Adding albumin to early standard resuscitation with lactated Ringer's in cancer patients with sepsis did not improve 7-day survival.,"[{'ForeName': 'Clarice Hyesuk Lee', 'Initials': 'CHL', 'LastName': 'Park', 'Affiliation': 'Department of Intensive Care, Cancer Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Juliano Pinheiro', 'Initials': 'JP', 'LastName': 'de Almeida', 'Affiliation': 'Department of Intensive Care, Cancer Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Gisele Queiroz', 'Initials': 'GQ', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Intensive Care, Cancer Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Stéphanie Itala', 'Initials': 'SI', 'LastName': 'Rizk', 'Affiliation': 'Department of Intensive Care, Cancer Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Julia Tizue', 'Initials': 'JT', 'LastName': 'Fukushima', 'Affiliation': 'Department of Intensive Care, Cancer Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Rosana Ely', 'Initials': 'RE', 'LastName': 'Nakamura', 'Affiliation': 'Department of Intensive Care, Cancer Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Matheus Moraes', 'Initials': 'MM', 'LastName': 'Mourão', 'Affiliation': 'Department of Intensive Care, Cancer Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Filomena Regina Barbosa Gomes', 'Initials': 'FRBG', 'LastName': 'Galas', 'Affiliation': 'Division of Anesthesia, Heart Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Edson', 'Initials': 'E', 'LastName': 'Abdala', 'Affiliation': 'Department of Infectious Diseases, Cancer Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Maristela', 'Initials': 'M', 'LastName': 'Pinheiro Freire', 'Affiliation': 'Department of Infectious Diseases, Cancer Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Kalil Filho', 'Affiliation': 'Department of Cardiopneumology, Heart Institute, Faculty of Medicine, University of Sao Paulo, Brazil.'}, {'ForeName': 'Jose Otavio', 'Initials': 'JO', 'LastName': 'Costa Auler', 'Affiliation': 'Division of Anesthesia, Heart Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Nardelli', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Greg S', 'Initials': 'GS', 'LastName': 'Martin', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care, Emory University, Atlanta, GA.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Ludhmila Abrahao', 'Initials': 'LA', 'LastName': 'Hajjar', 'Affiliation': 'Department of Intensive Care, Cancer Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}]",Critical care medicine,['10.1097/CCM.0000000000003900']
1946,31939768,Intergroup anxiety in pain care: impact on treatment recommendations made by white providers for black patients.,"Race disparities in pain care are well-documented. Given that most black patients are treated by white providers, patient-provider racial discordance is one hypothesized contributor to these disparities. Research and theory suggest that providers' trait-level intergroup anxiety impacts their state-level comfort while treating patients, which, in turn, impacts their pain treatment decisions. To test these hypothesized relationships, we conducted a planned secondary analysis of data from a randomized controlled trial of a perspective-taking intervention to reduce pain treatment disparities. Mediation analyses were conducted on treatment decision data from white providers for black virtual patients with chronic pain. Results indicated that white providers with higher trait-level intergroup anxiety reported lower state-level comfort treating black patients and were thereby more likely to recommend opioid (indirect effect = 0.76, 95% confidence interval [CI]: 0.21-1.51) and pain specialty (indirect effect = 0.91, 95% CI: 0.26-1.78) treatments and less likely to recommend nonopioid analgesics (indirect effect = -0.45, 95% CI: -0.94 to -0.12). Neither trait-level intergroup anxiety nor state-level comfort significantly influenced provider decisions for physical therapy. This study provides important new information about intrapersonal and interpersonal contributors to race disparities in chronic pain care. These findings suggest that intergroup anxiety and the resulting situational discomfort encroach on the clinical decision-making process by influencing white providers' decisions about which pain treatments to recommend to black patients. Should these findings be replicated in future studies, they would support interventions to help providers become more aware of their trait-level intergroup anxiety and manage their state-level reactions to patients who are racially/ethnically different from themselves.",2020,Neither trait-level intergroup anxiety nor state-level comfort significantly influenced provider decisions for physical therapy.,"['Black virtual patients with chronic pain', 'White providers for Black patients']",['perspective-taking intervention'],['pain specialty'],"[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0745156,Neither trait-level intergroup anxiety nor state-level comfort significantly influenced provider decisions for physical therapy.,"[{'ForeName': 'Alexis D', 'Initials': 'AD', 'LastName': 'Grant', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, Indianapolis, IN, United States.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Miller', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, Indianapolis, IN, United States.'}, {'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Hollingshead', 'Affiliation': 'Department of Family Medicine, The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Tracy M', 'Initials': 'TM', 'LastName': 'Anastas', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, Indianapolis, IN, United States.'}, {'ForeName': 'Adam T', 'Initials': 'AT', 'LastName': 'Hirsh', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, Indianapolis, IN, United States.'}]",Pain,['10.1097/j.pain.0000000000001806']
1947,31303296,"Unpacking the null: a post-hoc analysis of a cluster-randomised controlled trial of the WHO Safe Childbirth Checklist in Uttar Pradesh, India (BetterBirth).","BACKGROUND


A coaching-based implementation of the WHO Safe Childbirth Checklist in Uttar Pradesh, India, improved adherence to evidence-based practices, but did not reduce perinatal mortality, maternal morbidity, or maternal mortality. We examined facility-level correlates of the outcomes, which varied widely across the 120 study facilities.
METHODS


We did a post-hoc analysis of the coaching-based implementation of the WHO Safe Childbirth Checklist in Uttar Pradesh. We used multivariable modelling to identify correlations between 30 facility-level characteristics and each health outcome (perinatal mortality, maternal morbidity, or maternal mortality). To identify contexts in which the intervention might have had an effect, we then ran the models on data restricted to the period of intensive coaching and among patients not referred out of the facilities.
FINDINGS


In the multivariable context, perinatal mortality was associated with only 3 of the 30 variables: female literacy at the district level, geographical location, and previous neonatal mortality. Maternal morbidity was only associated with geographical location. No facility-level predictors were associated with maternal mortality. Among facilities in the lowest tertile of birth volume (<95 births per month), our models estimated perinatal mortality was 17 (95% CI 11·7-24·8) per 1000 births in the intervention group versus 38 (31·6-44·8) per 1000 in the control group (p<0·0001).
INTERPRETATION


Mortality was not directly associated with measured facility-level indicators but was associated with general risk factors. The absence of correlation between expected predictors and patient outcomes and the association between improved outcomes and the intervention in smaller facilities suggest a need for additional measures of quality of care that take into account complexity.
FUNDING


Bill & Melinda Gates Foundation.",2019,"In the multivariable context, perinatal mortality was associated with only 3 of the 30 variables: female literacy at the district level, geographical location, and previous neonatal mortality.","['WHO Safe Childbirth Checklist in Uttar Pradesh, India (BetterBirth']",[],"['Maternal morbidity', 'health outcome (perinatal mortality, maternal morbidity, or maternal mortality', 'perinatal mortality, maternal morbidity, or maternal mortality', 'perinatal mortality', 'birth volume', 'maternal mortality']","[{'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]",[],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031062', 'cui_str': 'Perinatal Mortality'}, {'cui': 'C0024923', 'cui_str': 'Maternal Mortality'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",95.0,0.067101,"In the multivariable context, perinatal mortality was associated with only 3 of the 30 variables: female literacy at the district level, geographical location, and previous neonatal mortality.","[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Marx Delaney', 'Affiliation': 'Ariadne Labs, Boston, MA, USA.'}, {'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Miller', 'Affiliation': 'Ariadne Labs, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Bobanski', 'Affiliation': 'Ariadne Labs, Boston, MA, USA.'}, {'ForeName': 'Shambhavi', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Community Empowerment Lab, Lucknow, India.'}, {'ForeName': 'Vishwajeet', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Community Empowerment Lab, Lucknow, India.'}, {'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Karlage', 'Affiliation': 'Ariadne Labs, Boston, MA, USA.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Tuller', 'Affiliation': 'Ariadne Labs, Boston, MA, USA.'}, {'ForeName': 'Atul A', 'Initials': 'AA', 'LastName': 'Gawande', 'Affiliation': ""Ariadne Labs, Boston, MA, USA; Brigham and Women's Hospital, Boston, MA, USA; Harvard T H Chan School of Public Health, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Katherine E A', 'Initials': 'KEA', 'LastName': 'Semrau', 'Affiliation': ""Ariadne Labs, Boston, MA, USA; Brigham and Women's Hospital, Boston, MA, USA; Harvard T H Chan School of Public Health, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: ksemrau@ariadnelabs.org.""}]",The Lancet. Global health,['10.1016/S2214-109X(19)30261-X']
1948,32040141,Comparison of Integrated Outpatient Palliative Care With Standard Care in Patients With Parkinson Disease and Related Disorders: A Randomized Clinical Trial.,"Importance


Parkinson disease and related disorders (PDRD) have consequences for quality of life (QoL) and are the 14th leading cause of death in the United States. Despite growing interest in palliative care (PC) for persons with PDRD, few studies are available supporting its effectiveness.
Objective


To determine if outpatient PC is associated with improvements in patient-centered outcomes compared with standard care among patients with PDRD and their caregivers.
Design, Setting, and Participants


This randomized clinical trial enrolled participants at 3 academic tertiary care centers between November 1, 2015, and September 30, 2017, and followed them up for 1 year. A total of 584 persons with PDRD were referred to the study. Of those, 351 persons were excluded by phone and 23 were excluded during in-person screenings. Patients were eligible to participate if they had PDRD and moderate to high PC needs. Patients were excluded if they had urgent PC needs, another diagnosis meriting PC, were already receiving PC, or were unable or unwilling to follow the study protocol. Enrolled participants were assigned to receive standard care plus outpatient integrated PC or standard care alone. Data were analyzed between November 1, 2018, and December 9, 2019.
Interventions


Outpatient integrated PC administered by a neurologist, social worker, chaplain, and nurse using PC checklists, with guidance and selective involvement from a palliative medicine specialist. Standard care was provided by a neurologist and a primary care practitioner.
Main Outcomes and Measures


The primary outcomes were the differences in patient quality of life (QoL; measured by the Quality of Life in Alzheimer Disease scale) and caregiver burden (measured by the Zarit Burden Interview) between the PC intervention and standard care groups at 6 months.
Results


A total of 210 patients with PDRD (135 men [64.3%]; mean [SD] age, 70.1 [8.2] years) and 175 caregivers (128 women [73.1%]; mean [SD] age, 66.1 [11.1] years) were enrolled in the study; 193 participants (91.9%) were white and non-Hispanic. Compared with participants receiving standard care alone at 6 months, participants receiving the PC intervention had better QoL (mean [SD], 0.66 [5.5] improvement vs 0.84 [4.2] worsening; treatment effect estimate, 1.87; 95% CI, 0.47-3.27; P = .009). No significant difference was observed in caregiver burden (mean [SD], 2.3 [5.0] improvement vs 1.2 [5.6] improvement in the standard care group; treatment effect estimate, -1.62; 95% CI, -3.32 to 0.09; P = .06). Other significant differences favoring the PC intervention included nonmotor symptom burden, motor symptom severity, completion of advance directives, caregiver anxiety, and caregiver burden at 12 months. No outcomes favored standard care alone. Secondary analyses suggested that benefits were greater for persons with higher PC needs.
Conclusions and Relevance


Outpatient PC is associated with benefits among patients with PDRD compared with standard care alone. This study supports efforts to integrate PC into PDRD care. The lack of diversity and implementation of PC at experienced centers suggests a need for implementation research in other populations and care settings.
Trial Registration


ClinicalTrials.gov Identifier: NCT02533921.",2020,"Other significant differences favoring the PC intervention included nonmotor symptom burden, motor symptom severity, completion of advance directives, caregiver anxiety, and caregiver burden at 12 months.","['584 persons with PDRD', 'persons with PDRD', 'patients with PDRD and their caregivers', 'patients with PDRD', 'Patients were excluded if they had urgent PC needs, another diagnosis meriting PC, were already receiving PC, or were unable or unwilling to follow the study protocol', 'Patients were eligible to participate if they had PDRD and moderate to high PC needs', 'Patients With Parkinson Disease and Related Disorders', '210 patients with PDRD (135 men [64.3%]; mean [SD] age, 70.1\u2009[8.2] years) and 175 caregivers (128 women [73.1%]; mean [SD] age, 66.1 [11.1] years) were enrolled in the study; 193 participants (91.9', '351 persons were excluded by phone and 23 were excluded during in-person screenings', 'participants at 3 academic tertiary care centers between November 1, 2015, and September 30, 2017, and followed them up for 1 year']","['Integrated Outpatient Palliative Care', 'standard care plus outpatient integrated PC or standard care alone', 'PC intervention']","['nonmotor symptom burden, motor symptom severity, completion of advance directives, caregiver anxiety, and caregiver burden', 'caregiver burden', 'patient quality of life (QoL; measured by the Quality of Life in Alzheimer Disease scale) and caregiver burden (measured by the Zarit Burden Interview']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0222045'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]",210.0,0.101226,"Other significant differences favoring the PC intervention included nonmotor symptom burden, motor symptom severity, completion of advance directives, caregiver anxiety, and caregiver burden at 12 months.","[{'ForeName': 'Benzi M', 'Initials': 'BM', 'LastName': 'Kluger', 'Affiliation': 'Department of Neurology, Anschutz Medical Campus, University of Colorado, Denver, Aurora.'}, {'ForeName': 'Janis', 'Initials': 'J', 'LastName': 'Miyasaki', 'Affiliation': 'Department of Neurology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Katz', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Galifianakis', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Kirk', 'Initials': 'K', 'LastName': 'Hall', 'Affiliation': 'Department of Neurology, Anschutz Medical Campus, University of Colorado, Denver, Aurora.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Pantilat', 'Affiliation': 'Division of Palliative Medicine, Department of Medicine, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Khan', 'Affiliation': 'Department of Neurology, Anschutz Medical Campus, University of Colorado, Denver, Aurora.'}, {'ForeName': 'Cari', 'Initials': 'C', 'LastName': 'Friedman', 'Affiliation': 'Department of Neurology, Anschutz Medical Campus, University of Colorado, Denver, Aurora.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Cernik', 'Affiliation': 'Department of Neurology, Anschutz Medical Campus, University of Colorado, Denver, Aurora.'}, {'ForeName': 'Yuika', 'Initials': 'Y', 'LastName': 'Goto', 'Affiliation': 'Division of Palliative Medicine, Department of Medicine, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Long', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Fairclough', 'Affiliation': 'Department of Biostatistics and Informatics, School of Public Health, University of Colorado, Aurora.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Sillau', 'Affiliation': 'Department of Neurology, Anschutz Medical Campus, University of Colorado, Denver, Aurora.'}, {'ForeName': 'Jean S', 'Initials': 'JS', 'LastName': 'Kutner', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, School of Medicine, University of Colorado, Aurora.'}]",JAMA neurology,['10.1001/jamaneurol.2019.4992']
1949,31765004,Medication Use Quality and Safety in Older Adults: 2018 Update.,"Improving the quality of medication use and medication safety is an important priority for prescribers who care for older adults. The objective of this article was to identify key articles from 2018 that address these issues. In addition, we selected four of these articles to annotate, critique, and discuss their broader implications for clinical practice. The first study highlights a cluster-randomized trial that utilized a pharmacist-led education-based intervention delivered to both patients and physicians to deprescribe four types of inappropriate medications (sedative-hypnotics, first-generation antihistamines, selective nonsteroidal anti-inflammatory drugs, and glyburide). The second study, a nested case-control study using data from within the UK Clinical Practice Research Datalink, examined the association between anticholinergic exposure, overall and by anticholinergic medication class, and dementia risk in 40 770 older adults. The third study, a longitudinal cohort study of 1028 Swedish older adults, examined the association between antihypertensive medications and incident dementia. The last study was a randomized, double-blind, placebo-controlled trial that investigated the effect of daily low-dose aspirin (100 mg) for primary prevention on cardiovascular events and major hemorrhage in 19 144 community-dwelling older adults. Collectively, this current article provides insight into the pertinent topics of medication use quality and safety in older adults and helps raise awareness about optimal prescribing in older adults. J Am Geriatr Soc 67:2458-2462, 2019.",2019,"The first study highlights a cluster-randomized trial that utilized a pharmacist-led education-based intervention delivered to both patients and physicians to deprescribe four types of inappropriate medications (sedative-hypnotics, first-generation antihistamines, selective nonsteroidal anti-inflammatory drugs, and glyburide).","['1028 Swedish older adults', 'prescribers who care for older adults', 'older adults', '19\u2009144 community-dwelling older adults', 'Older Adults', '40\u2009770 older adults']","['placebo', 'pharmacist-led education-based intervention delivered to both patients and physicians to deprescribe four types of inappropriate medications (sedative-hypnotics, first-generation antihistamines, selective nonsteroidal anti-inflammatory drugs, and glyburide', 'daily low-dose aspirin']","['cardiovascular events and major hemorrhage', 'quality of medication use and medication safety']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C4517873', 'cui_str': '770'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C4046040', 'cui_str': 'Deprescribing'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate component (foundation metadata concept)'}, {'cui': 'C0036557', 'cui_str': 'Sedatives'}, {'cui': 'C0020591', 'cui_str': 'Hypnotics'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0017628', 'cui_str': 'glibenclamide'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1028.0,0.0307063,"The first study highlights a cluster-randomized trial that utilized a pharmacist-led education-based intervention delivered to both patients and physicians to deprescribe four types of inappropriate medications (sedative-hypnotics, first-generation antihistamines, selective nonsteroidal anti-inflammatory drugs, and glyburide).","[{'ForeName': 'Nagham J', 'Initials': 'NJ', 'LastName': 'Ailabouni', 'Affiliation': 'Department of Pharmacy, University of Washington, Seattle, Washington.'}, {'ForeName': 'Zachary A', 'Initials': 'ZA', 'LastName': 'Marcum', 'Affiliation': 'Department of Pharmacy, University of Washington, Seattle, Washington.'}, {'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Schmader', 'Affiliation': 'Department of Medicine (Geriatrics), School of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Shelly L', 'Initials': 'SL', 'LastName': 'Gray', 'Affiliation': 'Department of Pharmacy, University of Washington, Seattle, Washington.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16243']
1950,32039955,No Difference in 5-year Clinical or Radiographic Outcomes Between Kinematic and Mechanical Alignment in TKA: A Randomized Controlled Trial.,"BACKGROUND


In kinematic alignment in TKA, the aim is to match the implant's position to the pre-arthritic anatomy of an individual patient, in contrast to the traditional goal of neutral mechanical alignment. However, there are limited mid-term, comparative data for survivorship and functional outcomes for these two techniques.
QUESTIONS/PURPOSES


In the setting of a randomized, controlled trial at 5 years, is there a difference between kinematic alignment and mechanical alignment in TKA in terms of (1) patient-reported outcome measures, (2) survivorship free from revision or reoperation, and (3) the incidence of radiographic aseptic loosening?
METHODS


In the initial study, 99 primary TKAs for osteoarthritis were randomized to either the mechanical alignment (n = 50) or kinematic alignment (n = 49) group. Computer navigation was used in the mechanical alignment group, and patient-specific cutting blocks were used in the kinematic alignment group. At 5 years, 95% (48 of 50) of mechanical alignment and 96% (47 of 49) of kinematic alignment TKAs were available for follow-up. Knee function was assessed using the Knee Society Score (KSS), VAS, Oxford Knee Score (OKS), WOMAC, Forgotten Joint Score (FJS) and EuroQol 5D. Survivorship free from reoperation (any reason) and revision (change or addition of any component) was determined via Kaplan-Meier analysis. Radiographs were assessed for signs of aseptic loosening (as defined by the presence of progressive radiolucent lines in two or more zones) by a single blinded observer.
RESULTS


At 5 years, there were no differences in any patient-reported outcome measure between the two groups. For example, the mean OKS did not differ between the two groups (kinematic alignment: 41.4 ± 7.2 versus mechanical alignment: 41.7 ± 6.3; difference -0.3 [95% confidence interval - 3.2 to 2.5]; p = 0.99). At 5 years, survivorship free from reoperation was 92.2 (95% CI 80.4 to 97.0) for mechanical alignment and 89.7 (95% CI 77.0 to 95.6) for kinematic alignment (log rank test; p = 0.674), survivorship free from revision was 94.1 (95% CI 82.9 to 98.1) for mechanical alignment and 95.9 (95% CI 84.5 to 99.0) for kinematic alignment (log rank test; p = 0.681). At 5 years, one patient demonstrated radiographic aseptic loosening for the mechanical alignment group; no cases were identified for the kinematic alignment group.
CONCLUSIONS


We found no mid-term functional or radiographic differences between TKAs with mechanical alignment or kinematic alignment. The anticipated improvements in patient-reported outcomes with kinematic alignment were not realized. Because kinematic alignment results in a high proportion of patients whose tibial components are inserted in varus, loosening remains a potential long-term concern. Given the unknown impact on long-term survivorship of the substantial alignment alterations with kinematic alignment, our findings do not support the routine use of kinematic alignment outside of a research setting.
LEVEL OF EVIDENCE


Level I, therapeutic study.",2020,"At 5 years, survivorship free from reoperation was 92.2 (95% CI 80.4 to 97.0) for mechanical alignment and 89.7 (95% CI 77.0 to 95.6) for kinematic alignment (log rank test; p = 0.674), survivorship free from revision was 94.1 (95% CI 82.9 to 98.1) for mechanical alignment and 95.9 (95% CI 84.5 to 99.0) for kinematic alignment (log rank test; p = 0.681).","['99 primary TKAs for osteoarthritis', 'TKA']",['mechanical alignment (n = 50) or kinematic alignment'],"['Knee Society Score (KSS), VAS, Oxford Knee Score (OKS), WOMAC, Forgotten Joint Score (FJS) and EuroQol 5D. Survivorship free from reoperation (any reason) and revision (change or addition of any component', 'survivorship free from revision', '5-year Clinical or Radiographic Outcomes', 'survivorship free from reoperation', 'mean OKS', 'Knee function', 'radiographic aseptic loosening', 'signs of aseptic loosening']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score (observable entity)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0038955'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C0333050', 'cui_str': 'Loosening (morphologic abnormality)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}]",99.0,0.152917,"At 5 years, survivorship free from reoperation was 92.2 (95% CI 80.4 to 97.0) for mechanical alignment and 89.7 (95% CI 77.0 to 95.6) for kinematic alignment (log rank test; p = 0.674), survivorship free from revision was 94.1 (95% CI 82.9 to 98.1) for mechanical alignment and 95.9 (95% CI 84.5 to 99.0) for kinematic alignment (log rank test; p = 0.681).","[{'ForeName': 'Simon W', 'Initials': 'SW', 'LastName': 'Young', 'Affiliation': 'S. W. Young, Department of Surgery, University of Auckland, Auckland, New Zealand S. W. Young, M. L. Walker, S. Holland, A. Bayan, B. Farrington, Department of Orthopaedic Surgery, North Shore Hospital, Auckland New Zealand N. P. T. Sullivan, Orthopaedic Department, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Niall P T', 'Initials': 'NPT', 'LastName': 'Sullivan', 'Affiliation': ''}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Walker', 'Affiliation': ''}, {'ForeName': 'Sherina', 'Initials': 'S', 'LastName': 'Holland', 'Affiliation': ''}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Bayan', 'Affiliation': ''}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Farrington', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001150']
1951,32056129,"Cladribine Tablets and Relapsing-Remitting Multiple Sclerosis: A Pragmatic, Narrative Review of What Physicians Need to Know.","Immune reconstitution therapy (IRT) is an emerging management concept for multiple sclerosis, whereby a short course of treatment provides long-lasting suppression of disease activity. ""Cladribine tablets 10 mg"" refers to a total cumulative dose of cladribine given over 2 years (henceforth referred to as cladribine tablets 3.5 mg/kg); it is a relatively new treatment option that is hypothesised to act as an IRT acting preferentially on the adaptive immune system. A randomised, 2-year, placebo-controlled trial (CLARITY) showed that treatment with cladribine tablets reduced indices of disease activity (relapses, lesions on magnetic resonance images, disability progression) and that this effect outlasted the pharmacologic effect of the treatment on the immune system (mainly a reduction in circulating B and T cells, with little effect on components of the innate immune system such as monocytes). CLARITY Extension, a 2-year extension to this trial, demonstrated durable efficacy, also in patients who received the standard 2-year course of cladribine tablets 3.5 mg/kg and were re-randomised to placebo for a further 2 years. Relative risk reductions for relapse rate with cladribine tablets 3.5 mg/kg were similar for patients with or without prior high disease activity. Reductions in disability progression with cladribine tablets 3.5 mg/kg were higher in patients with prior high relapse rates with or without prior treatment non-response. In this review, we describe the therapeutic profile of cladribine tablets 3.5 mg/kg and provide practical information on initiating this treatment option in the most appropriate patients.",2020,Reductions in disability progression with cladribine tablets 3.5 mg/kg were higher in patients with prior high relapse rates with or without prior treatment non-response.,['and Relapsing-Remitting Multiple Sclerosis'],"['cladribine tablets', 'Immune reconstitution therapy (IRT', 'placebo', 'Cladribine', 'Cladribine Tablets', 'cladribine']","['disability progression', 'disease activity (relapses, lesions on magnetic resonance images, disability progression']","[{'cui': 'C0751967', 'cui_str': 'Multiple Sclerosis, Relapsing-Remitting'}]","[{'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C4505207', 'cui_str': 'Immune Regeneration'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]",,0.0957267,Reductions in disability progression with cladribine tablets 3.5 mg/kg were higher in patients with prior high relapse rates with or without prior treatment non-response.,"[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'AlJumah', 'Affiliation': 'King Fahad Medical City, Ministry of Health, Riyadh, Kingdom of Saudi Arabia. jumahm@gmail.com.'}, {'ForeName': 'Mona Marwan', 'Initials': 'MM', 'LastName': 'Alkhawajah', 'Affiliation': 'King Faisal Specialist Hospital and Research Center, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Shireen', 'Initials': 'S', 'LastName': 'Qureshi', 'Affiliation': 'Johns Hopkins Aramco Healthcare, Dhahran, Kingdom of Saudi Arabia.'}, {'ForeName': 'Ibtisam', 'Initials': 'I', 'LastName': 'Al-Thubaiti', 'Affiliation': 'King Fahad Military Medical Complex, Dhahran, Kingdom of Saudi Arabia.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Ayoub', 'Affiliation': 'King Abdulaziz University, Jeddah, Kingdom of Saudi Arabia.'}, {'ForeName': 'Saeed A', 'Initials': 'SA', 'LastName': 'Bohlega', 'Affiliation': 'King Faisal Specialist Hospital and Research Center, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Areej', 'Initials': 'A', 'LastName': 'Bushnag', 'Affiliation': 'International Medical Center, Jeddah, Kingdom of Saudi Arabia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Cupler', 'Affiliation': 'King Faisal Specialist Hospital and Research Center, Jeddah, Kingdom of Saudi Arabia.'}, {'ForeName': 'Abdulkader', 'Initials': 'A', 'LastName': 'Daif', 'Affiliation': 'King Khaled University Hospital, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'El Boghdady', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hassan', 'Affiliation': 'King Faisal Specialist Hospital and Research Center, Jeddah, Kingdom of Saudi Arabia.'}, {'ForeName': 'Yaser', 'Initials': 'Y', 'LastName': 'Al Malik', 'Affiliation': 'King Saud Bin Abdulaziz University for Health Sciences (KSBU-HS), King Abdulaziz Medical City, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Jameelah', 'Initials': 'J', 'LastName': 'Saeedi', 'Affiliation': 'King Abdullah Bin Abdulaziz University Hospital, KAAUH, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Fawzia', 'Initials': 'F', 'LastName': 'Al-Shamrany', 'Affiliation': 'Imam Abdulrahman Bin Faisal University, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Eslam', 'Initials': 'E', 'LastName': 'Shosha', 'Affiliation': 'King Khaled Hospital, Al-Majmaah, Kingdom of Saudi Arabia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rieckmann', 'Affiliation': 'Bamberg Hospital and University of Erlangen, Bamberg, Germany.'}]",Neurology and therapy,['10.1007/s40120-020-00177-5']
1952,31848231,Relapse recovery: The forgotten variable in multiple sclerosis clinical trials.,"OBJECTIVE


To determine whether basing the decision to initiate immediate vs delayed disease-modifying therapy (DMT) on extent of recovery after initial relapse affects long-term disability accumulation in a multiple sclerosis (MS) evidence-based setting.
METHODS


We analyzed the double-blind, placebo-controlled interferon beta-1a 30 mc once a week in clinically isolated syndrome and 10-year-follow-up extension trial. Good recovery after presenting relapse was defined as (1) full early recovery within 28 days of symptom onset (Expanded Disability Status Scale [EDSS] score of 0 at enrollment maintained ≥6 months) and (2) delayed good recovery (EDSS score > 0 at enrollment and improvement from peak deficit to 6th-month or 1-year visit ≥ median). Time from recovery assignment to future disability (EDSS score ≥ 2.5 or ≥4.0) was studied on a relapse-recovery-stratified age axis and immediate vs 3-year delayed treatment initiation with Kaplan-Meier statistics and hazard ratios (HRs).
RESULTS


One hundred seventy-five/328 patients had good recovery (94 immediate and 81 delayed treatment); 153 did not have good recovery (77 immediate and 76 delayed treatment). HRs for EDSS score ≥2.5 outcome were: delayed treatment without good recovery as reference (HR = 1.0), delayed treatment with good recovery (HR 6th-month : 0.67,  p  = 0.207; HR 1st-year : 0.40,  p  = 0.027), immediate treatment without good recovery (HR 6th-month : 0.56,  p  = 0.061; HR 1st-year : 0.40,  p  = 0.011), and immediate treatment with good recovery (HR 6th-month : 0.43,  p  = 0.014; HR 1st-year : 0.48,  p  = 0.034). Placebo patients were switched to long-term treatment after 3 years, and insufficient EDSS score ≥4.0 outcome events were available to study.
CONCLUSIONS


In patients with MS presenting without good recovery after the initial relapse, immediate DMT initiation favorably influences the likelihood of more ambulatory-benign disease akin to patients with good recovery after the initial relapse.
CLASSIFICATION OF EVIDENCE


This study provides Class III evidence that for patients with MS without good recovery after the initial relapse, immediate DMT initiation increases the likelihood of a benign disease course.",2020,"HRs for EDSS score ≥2.5 outcome were: delayed treatment without good recovery as reference (HR = 1.0), delayed treatment with good recovery (HR 6th-month : 0.67,  p  = 0.207; HR 1st-year : 0.40,  p  = 0.027), immediate treatment without good recovery (HR 6th-month : 0.56,  p  = 0.061; HR 1st-year : 0.40,  p  = 0.011), and immediate treatment with good recovery (HR 6th-month : 0.43,  p  = 0.014; HR 1st-year : 0.48,  p  = 0.034).",['One hundred seventy-five/328 patients had good recovery (94 immediate and 81 delayed treatment); 153 did not have good recovery (77 immediate and 76 delayed treatment'],"['placebo-controlled interferon', 'Placebo', 'immediate vs delayed disease-modifying therapy (DMT']","['symptom onset (Expanded Disability Status Scale [EDSS] score', 'Relapse recovery']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C3693346', 'cui_str': 'Delayed Treatment'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0027183', 'cui_str': 'Dimethyltryptamine'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",30.0,0.0486372,"HRs for EDSS score ≥2.5 outcome were: delayed treatment without good recovery as reference (HR = 1.0), delayed treatment with good recovery (HR 6th-month : 0.67,  p  = 0.207; HR 1st-year : 0.40,  p  = 0.027), immediate treatment without good recovery (HR 6th-month : 0.56,  p  = 0.061; HR 1st-year : 0.40,  p  = 0.011), and immediate treatment with good recovery (HR 6th-month : 0.43,  p  = 0.014; HR 1st-year : 0.48,  p  = 0.034).","[{'ForeName': 'Orhun H', 'Initials': 'OH', 'LastName': 'Kantarci', 'Affiliation': 'From the Department of Neurology (O.H.K., B.Z., M.R.), Mayo Clinic College of Medicine, Mayo Clinic Center for Multiple Sclerosis and CNS Demyelinating Diseases; Department of Health Sciences Research (E.J.A.), Mayo Clinic College of Medicine; Department of Radiology (B.Z.), Mayo Clinic College of Medicine; Department of Neurology (B.L.C.), Formerly a Clinical Fellow at the Mayo Clinic College of Medicine, Mayo Clinic Center for Multiple Sclerosis and CNS Demyelinating Diseases, Rochester, MN; HealthPartners Neuroscience Center (B.L.C.), Saint Paul, MN; and US Medical (C.C-.V.), Biogen Inc., Boston, MA. kantarci.orhun@mayo.edu.'}, {'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Zeydan', 'Affiliation': 'From the Department of Neurology (O.H.K., B.Z., M.R.), Mayo Clinic College of Medicine, Mayo Clinic Center for Multiple Sclerosis and CNS Demyelinating Diseases; Department of Health Sciences Research (E.J.A.), Mayo Clinic College of Medicine; Department of Radiology (B.Z.), Mayo Clinic College of Medicine; Department of Neurology (B.L.C.), Formerly a Clinical Fellow at the Mayo Clinic College of Medicine, Mayo Clinic Center for Multiple Sclerosis and CNS Demyelinating Diseases, Rochester, MN; HealthPartners Neuroscience Center (B.L.C.), Saint Paul, MN; and US Medical (C.C-.V.), Biogen Inc., Boston, MA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Atkinson', 'Affiliation': 'From the Department of Neurology (O.H.K., B.Z., M.R.), Mayo Clinic College of Medicine, Mayo Clinic Center for Multiple Sclerosis and CNS Demyelinating Diseases; Department of Health Sciences Research (E.J.A.), Mayo Clinic College of Medicine; Department of Radiology (B.Z.), Mayo Clinic College of Medicine; Department of Neurology (B.L.C.), Formerly a Clinical Fellow at the Mayo Clinic College of Medicine, Mayo Clinic Center for Multiple Sclerosis and CNS Demyelinating Diseases, Rochester, MN; HealthPartners Neuroscience Center (B.L.C.), Saint Paul, MN; and US Medical (C.C-.V.), Biogen Inc., Boston, MA.'}, {'ForeName': 'Brittani L', 'Initials': 'BL', 'LastName': 'Conway', 'Affiliation': 'From the Department of Neurology (O.H.K., B.Z., M.R.), Mayo Clinic College of Medicine, Mayo Clinic Center for Multiple Sclerosis and CNS Demyelinating Diseases; Department of Health Sciences Research (E.J.A.), Mayo Clinic College of Medicine; Department of Radiology (B.Z.), Mayo Clinic College of Medicine; Department of Neurology (B.L.C.), Formerly a Clinical Fellow at the Mayo Clinic College of Medicine, Mayo Clinic Center for Multiple Sclerosis and CNS Demyelinating Diseases, Rochester, MN; HealthPartners Neuroscience Center (B.L.C.), Saint Paul, MN; and US Medical (C.C-.V.), Biogen Inc., Boston, MA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Castrillo-Viguera', 'Affiliation': 'From the Department of Neurology (O.H.K., B.Z., M.R.), Mayo Clinic College of Medicine, Mayo Clinic Center for Multiple Sclerosis and CNS Demyelinating Diseases; Department of Health Sciences Research (E.J.A.), Mayo Clinic College of Medicine; Department of Radiology (B.Z.), Mayo Clinic College of Medicine; Department of Neurology (B.L.C.), Formerly a Clinical Fellow at the Mayo Clinic College of Medicine, Mayo Clinic Center for Multiple Sclerosis and CNS Demyelinating Diseases, Rochester, MN; HealthPartners Neuroscience Center (B.L.C.), Saint Paul, MN; and US Medical (C.C-.V.), Biogen Inc., Boston, MA.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Rodriguez', 'Affiliation': 'From the Department of Neurology (O.H.K., B.Z., M.R.), Mayo Clinic College of Medicine, Mayo Clinic Center for Multiple Sclerosis and CNS Demyelinating Diseases; Department of Health Sciences Research (E.J.A.), Mayo Clinic College of Medicine; Department of Radiology (B.Z.), Mayo Clinic College of Medicine; Department of Neurology (B.L.C.), Formerly a Clinical Fellow at the Mayo Clinic College of Medicine, Mayo Clinic Center for Multiple Sclerosis and CNS Demyelinating Diseases, Rochester, MN; HealthPartners Neuroscience Center (B.L.C.), Saint Paul, MN; and US Medical (C.C-.V.), Biogen Inc., Boston, MA.'}]",Neurology(R) neuroimmunology & neuroinflammation,['10.1212/NXI.0000000000000653']
1953,31186180,Is intraoperative fluoroscopy necessary in anterior cruciate ligament double-bundle reconstruction? A prospective randomized controlled trial.,"INTRODUCTION


Properly placed tibial and femoral tunnels in anterior cruciate ligament (ACL) reconstruction are important because tunnel misplacement can cause abnormal changes in graft tension patterns, resulting in postoperative knee laxity. To overcome the inaccuracy of tunnel position in ACL reconstruction, intraoperative fluoroscopy has been proven to be a useful method in previous studies focusing on the tunnel position in single-bundle reconstruction, but few studies are available on the efficacy and necessity of intraoperative fluoroscopy for double-bundle (DB) reconstruction. The purpose of this prospective randomized case-control study was to evaluate the effect of intraoperative fluoroscopy on femoral and tibial tunnel position in anatomic DB ACL reconstruction using a postoperative tunnel position in a three-dimensional computed tomography (3D-CT).
HYPOTHESIS


Intraoperative fluoroscopy during ACL DB reconstruction could make an appropriate tunnel position closer to the anatomical center compared to conventional fluoroscopy-free procedure.
MATERIAL AND METHODS


Sixty patients undergoing ACL DB reconstruction (30 fluoroscopy-free reconstruction group and 30 in fluoroscopy-assisted reconstruction group) were included in this prospective study, and randomly allocated into two groups. Mean values of the percentage distance of femoral and tibial tunnel center in a 3D-CT were compared between the two groups. Knee laxity (the anterior translation and pivot-shift grade) and clinical outcomes were also compared at the last follow-up.
RESULTS


There was a significant difference only in femoral anteromedial (AM) bundle tunnel position, but not in femoral posterolateral (PL) bundle, tibial AM, or PL bundle tunnel position between the two groups. Femoral AM bundle tunnel in the fluoroscopy-assisted reconstruction group showed significantly (p=0.005) deeper position compared to that in the fluoroscopy-free reconstruction group. There was no significant difference in anterior translation, pivot-shift grade, or clinical outcomes between the two groups.
DISCUSSION


Fluoroscopy-assisted ACL DB reconstruction can make deeper placement of the femoral AM bundle than the conventional ACL DB reconstruction.
LEVEL OF EVIDENCE


II, prospective randomized controlled trial.",2019,Femoral AM bundle tunnel in the fluoroscopy-assisted reconstruction group showed significantly (p=0.005) deeper position compared to that in the fluoroscopy-free reconstruction group.,['Sixty patients undergoing'],"['ACL DB reconstruction', 'Fluoroscopy-assisted ACL DB reconstruction', 'intraoperative fluoroscopy', 'ACL DB reconstruction (30 fluoroscopy-free reconstruction group and 30 in fluoroscopy-assisted reconstruction group']","['Femoral AM bundle tunnel', 'Mean values of the percentage distance of femoral and tibial tunnel center', 'femoral anteromedial (AM) bundle tunnel position', 'femoral posterolateral (PL) bundle, tibial AM, or PL bundle tunnel position', 'Knee laxity', 'anterior translation, pivot-shift grade, or clinical outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C3854183', 'cui_str': 'Tunneler (physical object)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0332536', 'cui_str': 'Laxness'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",60.0,0.0150934,Femoral AM bundle tunnel in the fluoroscopy-assisted reconstruction group showed significantly (p=0.005) deeper position compared to that in the fluoroscopy-free reconstruction group.,"[{'ForeName': 'Ji Hyun', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Department of Orthopedic Surgery, Dongguk University Ilsan Hospital, 27, Dongguk-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, 10326, Republic of Korea. Electronic address: drsky7171@gmail.com.'}, {'ForeName': 'Sangwoo', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Dongguk University Ilsan Hospital, 27, Dongguk-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, 10326, Republic of Korea.'}, {'ForeName': 'Jaehyun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Dongguk University Ilsan Hospital, 27, Dongguk-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, 10326, Republic of Korea.'}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2019.04.011']
1954,32057733,"Transverse, vertical, and anterior-posterior changes between tooth-anchored versus Dresden bone-anchored rapid maxillary expansion 6 months post-expansion: A CBCT randomized controlled clinical trial.","OBJECTIVE


The main aim of this randomized clinical trial was to determine 3 dimensional skeletal and dental changes six months after the use of bone-anchored versus tooth-anchored rapid maxillary expanders in adolescents. The secondary aim was to determine the symmetrical or asymmetrical expansion pattern between both appliances.
MATERIALS AND METHODS


Fifty adolescents with skeletally constricted maxilla (mean age 13-14 years) were randomly assigned into: Dresden B-RME, Hyrax T-RME, or untreated control groups. CBCT scans were taken at initial and expander removal (6 months). Three-dimensional references and treatment landmarks were identified. Orthogonal distances were calculated from those landmarks. The main outcome was to compare skeletal and dental changes in each group and the secondary outcome was to verify if these changes were symmetric or not. Data was analysed using descriptive statistics and repeated measure MANCOVA and MANOVA.
RESULTS


Both treatment groups showed significant skeletal and dental expansion compared to controls. T-RME group had greater mean inter-molar crown expansion (5.66mm) than the B-RME group (4.17mm). Both T-RME and B-RME groups showed significant skeletal maxillary expansion compared to controls (mean 1.27mm and 1.31mm respectively, both p<0.01), although no significant difference was found between both appliances. B-RME group showed a lower ratio of dental to skeletal expansion than T-RME group. T-RME showed a symmetrical expansion pattern, whereas the B-RME showed an asymmetrical pattern relative to mid-sagittal plane. The extent of molar crown expansion was 1.84mm greater on the TAD-side compared to the Implant-side. T-RME group showed significant anterior movement of the maxillary first premolar and molar (1.5mm, p<0.05), and vertical dental extrusion (1.8mm). No significant dental vertical or anterior-posterior changes were noted in the B-RME group.
CONCLUSIONS


T-RME and B-RME produced similar amounts of skeletal expansion. B-RME group produced a lower component of dental expansion. Due to the Dresden B-RME configuration, asymmetrical expansion was noted.",2020,T-RME group had greater mean inter-molar crown expansion (5.66mm) than the B-RME group (4.17mm).,"['Fifty adolescents with skeletally constricted maxilla (mean age 13-14 years', 'adolescents']","['tooth-anchored versus Dresden bone-anchored rapid maxillary expansion', 'bone-anchored versus tooth-anchored rapid maxillary expanders', 'Dresden B-RME, Hyrax T-RME, or untreated control groups']","['lower ratio of dental to skeletal expansion', 'Orthogonal distances', 'dental vertical or anterior-posterior changes', 'skeletal and dental expansion', 'molar crown expansion', 'skeletal maxillary expansion', 'skeletal and dental changes', 'mean inter-molar crown expansion']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1444778', 'cui_str': 'Constricting'}, {'cui': 'C0024947', 'cui_str': 'Maxillary Bone'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C1720978', 'cui_str': 'Bone Anchors'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0600288', 'cui_str': 'Maxillary Expansion'}, {'cui': 'C0020696', 'cui_str': 'Hyraxes'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C3853546', 'cui_str': 'Dental Crowns'}, {'cui': 'C0600288', 'cui_str': 'Maxillary Expansion'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]",50.0,0.0824566,T-RME group had greater mean inter-molar crown expansion (5.66mm) than the B-RME group (4.17mm).,"[{'ForeName': 'Manuel O', 'Initials': 'MO', 'LastName': 'Lagravère', 'Affiliation': 'University of Alberta, Orthodontic Graduate Program, ECHA 5-524, Faculty of Medicine and Dentistry, 11405-87 Ave, Edmonton, AB, Canada. Electronic address: mlagravere@ualberta.ca.'}, {'ForeName': 'Connie P', 'Initials': 'CP', 'LastName': 'Ling', 'Affiliation': 'Private Practice, Toronto, ON, Canada; Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Woo', 'Affiliation': 'Computer Engineer, Toronto, ON, Canada.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Harzer', 'Affiliation': 'Technical University of Dresden, Department of Orthodontics, Fetscherstr. 72, 01307 Dresden, Germany.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Major', 'Affiliation': 'University of Alberta, Orthodontic Graduate Program, ECHA 5-524, Faculty of Medicine and Dentistry, 11405-87 Ave, Edmonton, AB, Canada.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Carey', 'Affiliation': 'University of Alberta, Donadeo Innovation Centre for Engineering, Department of Mechanical Engineering, Faculty of Engineering, T6G 10-265 Edmonton, AB, Canada.'}]",International orthodontics,['10.1016/j.ortho.2020.01.003']
1955,32047601,Postoperative pain of patients with necrotic teeth with apical periodontitis following single visit endodontic treatment versus multiple visit endodontic treatment using triple antibiotic paste: a randomized clinical trial.,"Background:  A randomized clinical trial was conducted to compare the postoperative pain following endodontic treatment of necrotic teeth with apical periodontitis. Treatments were performed in multiple visits with application of triple antibiotic paste interappointment dressing or single visit without interappointment dressing.  Methods:  In total 44 participants were assigned randomly into two groups. Group A: multiple visit endodontic treatment with triple antibiotic paste interappointment dressing; group B: single visit endodontic treatment without interappointment dressing. Postoperative pain of participants was assessed after 24, 48, 72 hours and one week using numerical rating scale.  Results:  No statistically significant difference was found in postoperative pain after 24, 48, 72 hours and one week between the two groups.  Conclusion:  Triple antibiotic paste as an interappointment dressing in multiple visits endodontic treatment was not proved to reduce the postoperative pain compared to a single visit in patients with necrotic teeth with apical periodontitis who did not have an interappointment dressing.  Trial registration:  clinicaltrials.gov, NCT02947763. Date: 28th October 2016.",2019,"No statistically significant difference was found in postoperative pain after 24, 48, 72 hours and one week between the two groups.  ","['necrotic teeth with apical periodontitis', 'In total 44 participants', 'patients with necrotic teeth with apical periodontitis who did not have an interappointment dressing', 'patients with necrotic teeth with apical periodontitis']","['triple antibiotic paste interappointment dressing or single visit without interappointment dressing', 'triple antibiotic paste interappointment dressing; group B: single visit endodontic treatment without interappointment dressing', 'single visit endodontic treatment versus multiple visit endodontic treatment using triple antibiotic paste', 'Triple antibiotic paste']","['postoperative pain', 'Postoperative pain']","[{'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0031030', 'cui_str': 'Periodontitis, Apical'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}]","[{'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",44.0,0.229787,"No statistically significant difference was found in postoperative pain after 24, 48, 72 hours and one week between the two groups.  ","[{'ForeName': 'Safeya', 'Initials': 'S', 'LastName': 'AbdurRahman', 'Affiliation': 'Department of Endodontics, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Saied M', 'Initials': 'SM', 'LastName': 'Abdel Aziz', 'Affiliation': 'Department of Endodontics, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Shaimaa I', 'Initials': 'SI', 'LastName': 'Gawdat', 'Affiliation': 'Department of Endodontics, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'AbdalSamad', 'Affiliation': 'Department of Oral and Maxillofacial Radiology, Cairo University, Cairo, Egypt.'}]",F1000Research,['10.12688/f1000research.19936.1']
1956,30476165,Dolutegravir and lamivudine maintenance therapy in HIV-1 virologically suppressed patients: results of the ANRS 167 trial (LAMIDOL).,"OBJECTIVES


To evaluate the dolutegravir+lamivudine combination in virologically suppressed patients living with HIV.
METHODS


The ANRS 167 LAMIDOL trial was an open-label, single arm, multicentre trial assessing once-daily dolutegravir (50 mg)+lamivudine (300 mg) in virologically suppressed HIV-1 patients on first-line triple-drug regimens. The main criteria for inclusion in the trial were plasma viral load (pVL) ≤50 copies/mL for ≥2 years, CD4 nadir >200 cells/mm3 and WT HIV prior to treatment initiation. From week -8 (W-8) to day 0 (D0) (Phase 1), the current third agent was switched to dolutegravir. From D0 to W48 (Phase 2), patients received once-daily dolutegravir+lamivudine, except if intolerant or if pVL >50 copies/mL during Phase 1. Virological failure was defined as pVL >50 copies/mL in two consecutive samples. The study was designed to show that the strategy had an efficacy of ≥80%, assuming a 90% success rate with a type I error of 5% and a power of 90%.
RESULTS


In total, 104 of 110 patients enrolled in Phase 1 were included in Phase 2. These 104 patients were 86% male, 72% MSM and 87% CDC stage A. Their characteristics were (median): age 45 years, CD4 nadir 339 cells/mm3, baseline CD4 743 cells/mm3 and duration of viral suppression 4.5 years. The overall success rate at W48 was 97% (95% CI: 94%-100%), meeting the design expectation/assumption. Three therapeutic failures occurred: one virological failure at W4, one lost to follow-up at W32 and one interruption of therapeutic strategy at W40 after a blip (pVL 59 copies/mL but control pVL <50 copies/mL). Three viral blips occurred in two additional patients. Neither M184V nor integrase resistance mutations were detected after failure or blips.
CONCLUSIONS


Dolutegravir+lamivudine is a promising maintenance therapy in HIV-1-infected patients with controlled virological suppression.",2019,"The overall success rate at W48 was 97% (95% CI: 94%-100%), meeting the design expectation/assumption.","['HIV-1-infected patients with controlled virological suppression', 'In total, 104 of 110 patients enrolled in Phase 1 were included in Phase 2', '104 patients were 86% male, 72% MSM and 87% CDC stage A', 'HIV-1 virologically suppressed patients', 'Their characteristics were (median): age 45\u2009years, CD4 nadir 339 cells/mm3, baseline CD4 743 cells/mm3 and duration of viral suppression 4.5\u2009years', 'virologically suppressed patients living with HIV']","['lamivudine maintenance therapy', 'Dolutegravir+lamivudine', 'dolutegravir+lamivudine']","['integrase resistance mutations', 'overall success rate', 'Virological failure', 'viral blips']","[{'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0007670', 'cui_str': 'CDC'}, {'cui': 'C0441778', 'cui_str': 'Stage A (qualifier value)'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0439243', 'cui_str': 'mm3'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0063690', 'cui_str': 'Integrase'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",110.0,0.254662,"The overall success rate at W48 was 97% (95% CI: 94%-100%), meeting the design expectation/assumption.","[{'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Joly', 'Affiliation': 'IAME, UMR 1137, INSERM, Université Paris Diderot, Sorbonne Paris Cité, SMIT, Hôpital Bichat, AP-HP, Paris, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Burdet', 'Affiliation': ""IAME, UMR 1137, INSERM, Université Paris Diderot, Sorbonne Paris Cité, Département d'épidémiologie, Biostatistique et Recherche Clinique, Hôpital Bichat, AP-HP, Paris, France.""}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Landman', 'Affiliation': ""IMEA, Fondation Léon M'BA, Paris, France.""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Vigan', 'Affiliation': ""IAME, UMR 1137, INSERM, Université Paris Diderot, Sorbonne Paris Cité, Département d'épidémiologie, Biostatistique et Recherche Clinique, Hôpital Bichat, AP-HP, Paris, France.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Charpentier', 'Affiliation': 'IAME, UMR 1137, INSERM, Université Paris Diderot, Sorbonne Paris Cité, Laboratoire de Virologie, Hôpital Bichat, AP-HP, Paris, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Katlama', 'Affiliation': 'SMIT, Hôpital La Pitié Salpétrière, Paris, France.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Cabié', 'Affiliation': 'CIC1424 INSERM, Université des Antilles, SMIT, CHU de Martinique, Fort de France, France.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Benalycherif', 'Affiliation': ""IMEA, Fondation Léon M'BA, Paris, France.""}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Peytavin', 'Affiliation': 'IAME, UMR 1137, INSERM, Université Paris Diderot, Sorbonne Paris Cité, AP-HP, Laboratoire de Pharmacologie-Toxicologie, Hôpital Bichat, AP-HP, Paris, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Yeni', 'Affiliation': 'IAME, UMR 1137, INSERM, Université Paris Diderot, Sorbonne Paris Cité, SMIT, Hôpital Bichat, AP-HP, Paris, France.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Mentre', 'Affiliation': ""IAME, UMR 1137, INSERM, Université Paris Diderot, Sorbonne Paris Cité, Département d'épidémiologie, Biostatistique et Recherche Clinique, Hôpital Bichat, AP-HP, Paris, France.""}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Argoud', 'Affiliation': 'French Agency for Research on AIDS and Viral Hepatitis, Paris, France.'}, {'ForeName': 'Imane', 'Initials': 'I', 'LastName': 'Amri', 'Affiliation': 'French Agency for Research on AIDS and Viral Hepatitis, Paris, France.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Descamps', 'Affiliation': 'IAME, UMR 1137, INSERM, Université Paris Diderot, Sorbonne Paris Cité, Laboratoire de Virologie, Hôpital Bichat, AP-HP, Paris, France.'}, {'ForeName': 'Yazdan', 'Initials': 'Y', 'LastName': 'Yazdanpanah', 'Affiliation': 'IAME, UMR 1137, INSERM, Université Paris Diderot, Sorbonne Paris Cité, SMIT, Hôpital Bichat, AP-HP, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dky467']
1957,32039078,Remineralization Potential of Theobromine on Artificial Carious Lesions.,"Background and Aims


This study aimed to investigate the remineralization potential of two concentrations of theobromine (100 mg/L and 200 mmg/L) with fluoridated dentifrice, NovaMin, and nanohydroxyapatite using DIAGNOdent, scanning electron microscopy (SEM), and energy dispersive X-ray (EDX) analysis.
Materials and Methods


Two sections were taken from 50 teeth each. Artificial carious lesions were induced using demineralizing solution. Evaluation using DIAGNOdent, SEM, and EDX analysis for elemental evaluation of Ca/P ratio and fluoride ion was carried out. Teeth sections were then randomly assigned to five different groups: (1) fluoridated dentifrice (Colgate™, Colgate -Palmolive, India), Novamine- Shy NM™, Group pharamaceuticals, India), 3. Nano-hydroxyapatite- Remin Pro™, Voco, Germany) 4. 100mg and 5. 200mg of Theobromine toothpaste (Theodent classic™, Rennou, UK-853069003006). Remineralization was carried out for 14 days with two applications per day. Samples were reanalyzed using DIAGNOdent, SEM, and EDX.
Results


A Tukey  post-hoc  test revealed statistically significant difference between NovaMin and all the other toothpastes ( P  < 0.001) for DIAGNOdent readings. On performing SEM-EDX analysis, it was seen that all agents had remineralization potential; however, no significant difference was found.
Conclusion


Theobromine can be used as an effective novel remineralizing agent alternative to the already-available agents.",2019,"Results


A Tukey  post-hoc  test revealed statistically significant difference between NovaMin and all the other toothpastes ( P  < 0.001) for DIAGNOdent readings.",[],"['fluoridated dentifrice (Colgate™, Colgate -Palmolive, India), Novamine- Shy NM™, Group pharamaceuticals, India), 3', 'theobromine (100 mg/L and 200 mmg/L) with fluoridated dentifrice, NovaMin, and nanohydroxyapatite using DIAGNOdent, scanning electron microscopy (SEM), and energy dispersive X-ray (EDX) analysis', 'Theobromine toothpaste', 'Theobromine']",[],[],"[{'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C2345900', 'cui_str': 'Colgate'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0722163', 'cui_str': 'Novamine'}, {'cui': 'C0557869', 'cui_str': 'Introvert (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0039763', 'cui_str': 'Theobromine'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439268', 'cui_str': 'microgram/mL'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1722474', 'cui_str': 'NovaMin'}, {'cui': 'C0026019', 'cui_str': 'Electron Microscopy'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",[],2.0,0.019257,"Results


A Tukey  post-hoc  test revealed statistically significant difference between NovaMin and all the other toothpastes ( P  < 0.001) for DIAGNOdent readings.","[{'ForeName': 'Vani', 'Initials': 'V', 'LastName': 'Taneja', 'Affiliation': 'Department of Pedodontics & Preventive Dentistry, Manipal College of Dental Sciences (MCODS), Manipal, Karnataka, India.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Nekkanti', 'Affiliation': 'Department of Pedodontics & Preventive Dentistry, Manipal College of Dental Sciences (MCODS), Manipal, Karnataka, India.'}, {'ForeName': 'Kanishk', 'Initials': 'K', 'LastName': 'Gupta', 'Affiliation': 'Department of Pedodontics & Preventive Dentistry, Manipal College of Dental Sciences (MCODS), Manipal, Karnataka, India.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Hassija', 'Affiliation': 'Department of Pedodontics & Preventive Dentistry, Manipal College of Dental Sciences (MCODS), Manipal, Karnataka, India.'}]",Journal of International Society of Preventive & Community Dentistry,['10.4103/jispcd.JISPCD_265_19']
1958,32032096,"Preoperative Cognitive Abnormality, Intraoperative Electroencephalogram Suppression, and Postoperative Delirium: A Mediation Analysis.","BACKGROUND


Postoperative delirium is a common complication that hinders recovery after surgery. Intraoperative electroencephalogram suppression has been linked to postoperative delirium, but it is unknown if this relationship is causal or if electroencephalogram suppression is merely a marker of underlying cognitive abnormalities. The hypothesis of this study was that intraoperative electroencephalogram suppression mediates a nonzero portion of the effect between preoperative abnormal cognition and postoperative delirium.
METHODS


This is a prespecified secondary analysis of the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) randomized trial, which enrolled patients age 60 yr or older undergoing surgery with general anesthesia at a single academic medical center between January 2015 and May 2018. Patients were randomized to electroencephalogram-guided anesthesia or usual care. Preoperative abnormal cognition was defined as a composite of previous delirium, Short Blessed Test cognitive score greater than 4 points, or Eight Item Interview to Differentiate Aging and Dementia score greater than 1 point. Duration of intraoperative electroencephalogram suppression was defined as number of minutes with suppression ratio greater than 1%. Postoperative delirium was detected via Confusion Assessment Method or chart review on postoperative days 1 to 5.
RESULTS


Among 1,113 patients, 430 patients showed evidence of preoperative abnormal cognition. These patients had an increased incidence of postoperative delirium (151 of 430 [35%] vs.123 of 683 [18%], P < 0.001). Of this 17.2% total effect size (99.5% CI, 9.3 to 25.1%), an absolute 2.4% (99.5% CI, 0.6 to 4.8%) was an indirect effect mediated by electroencephalogram suppression, while an absolute 14.8% (99.5% CI, 7.2 to 22.5%) was a direct effect of preoperative abnormal cognition. Randomization to electroencephalogram-guided anesthesia did not change the mediated effect size (P = 0.078 for moderation).
CONCLUSIONS


A small portion of the total effect of preoperative abnormal cognition on postoperative delirium was mediated by electroencephalogram suppression. Study precision was too low to determine if the intervention changed the mediated effect.",2020,"These patients had an increased incidence of postoperative delirium (151 of 430 [35%] vs.123 of 683 [18%], P < 0.001).","['1,113 patients, 430 patients', 'patients with preexisting cognitive impairment', 'enrolled patients age 60 yr or older undergoing surgery with general anesthesia at a single academic medical center between January 2015 and May 2018']","['Intraoperative electroencephalogram suppression', 'Electroencephalography Guidance of Anesthesia', 'electroencephalogram-guided anesthesia or usual care', 'intraoperative electroencephalogram suppression']","['Postoperative delirium', 'Duration of intraoperative electroencephalogram suppression', 'incidence of postoperative delirium', 'Preoperative abnormal cognition', 'preoperative abnormal cognition', 'postoperative delirium', 'Preoperative Cognitive Abnormality, Intraoperative Electroencephalogram Suppression, and Postoperative Delirium']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]",,0.120379,"These patients had an increased incidence of postoperative delirium (151 of 430 [35%] vs.123 of 683 [18%], P < 0.001).","[{'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Fritz', 'Affiliation': 'From the Department of Anesthesiology (B.A.F., C.R.K., A.B., A.M.M., T.P.B., J.O., D.P., H.R.M., T.S.W., M.S.A) the Division of Biostatistics (N.L.), Washington University School of Medicine, St. Louis, Missouri the Department of Mathematics and Statistics, Washington University in St. Louis, St. Louis, Missouri (N.L.). Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, University of Manitoba, Winnipeg, Canada Department of Medicine, Beth Israel-Deaconess Medical Center, Boston, Massachusetts Department of Medicine, Beth Israel-Deaconess Medical Center, Boston, Massachusetts Department of Medicine, Beth Israel-Deaconess Medical Center, Boston, Massachusetts Department of Medicine, Beth Israel-Deaconess Medical Center, Boston, Massachusetts Department of Occupational Therapy, Washington University School of Medicine, St. Louis, Missouri Department of Occupational Therapy, Washington University School of Medicine, St. Louis, Missouri Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri Department of Surgery, Washington University School of Medicine, St. Louis, Missouri Department of Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'King', 'Affiliation': ''}, {'ForeName': 'Arbi', 'Initials': 'A', 'LastName': 'Ben Abdallah', 'Affiliation': ''}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Mickle', 'Affiliation': ''}, {'ForeName': 'Thaddeus P', 'Initials': 'TP', 'LastName': 'Budelier', 'Affiliation': ''}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Oberhaus', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Maybrier', 'Affiliation': ''}, {'ForeName': 'Troy S', 'Initials': 'TS', 'LastName': 'Wildes', 'Affiliation': ''}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Avidan', 'Affiliation': ''}, {'ForeName': 'Ginika', 'Initials': 'G', 'LastName': 'Apakama', 'Affiliation': ''}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Aranake-Chrisinger', 'Affiliation': ''}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bolzenius', 'Affiliation': ''}, {'ForeName': 'Jamila', 'Initials': 'J', 'LastName': 'Burton', 'Affiliation': ''}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Cui', 'Affiliation': ''}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Emmert', 'Affiliation': ''}, {'ForeName': 'Shreya', 'Initials': 'S', 'LastName': 'Goswami', 'Affiliation': ''}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Graetz', 'Affiliation': ''}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': ''}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Jordan', 'Affiliation': ''}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kronzer', 'Affiliation': ''}, {'ForeName': 'Sherry L', 'Initials': 'SL', 'LastName': 'McKinnon', 'Affiliation': ''}, {'ForeName': 'Maxwell R', 'Initials': 'MR', 'LastName': 'Muench', 'Affiliation': ''}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Murphy', 'Affiliation': ''}, {'ForeName': 'Ben J', 'Initials': 'BJ', 'LastName': 'Palanca', 'Affiliation': ''}, {'ForeName': 'Aamil', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Spencer', 'Affiliation': ''}, {'ForeName': 'Tracey W', 'Initials': 'TW', 'LastName': 'Stevens', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Strutz', 'Affiliation': ''}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Tedeschi', 'Affiliation': ''}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Torres', 'Affiliation': ''}, {'ForeName': 'Emma R', 'Initials': 'ER', 'LastName': 'Trammel', 'Affiliation': ''}, {'ForeName': 'Ravi T', 'Initials': 'RT', 'LastName': 'Upadhyayula', 'Affiliation': ''}, {'ForeName': 'Anke C', 'Initials': 'AC', 'LastName': 'Winter', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Jacobsohn', 'Affiliation': ''}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Fong', 'Affiliation': ''}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Gallagher', 'Affiliation': ''}, {'ForeName': 'Sharon K', 'Initials': 'SK', 'LastName': 'Inouye', 'Affiliation': ''}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Schmitt', 'Affiliation': ''}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Somerville', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stark', 'Affiliation': ''}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': ''}, {'ForeName': 'Spencer J', 'Initials': 'SJ', 'LastName': 'Melby', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Tappenden', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003181']
1959,32038358,Effects of Two Teaching Strategies on Preschoolers' Oral Language Skills: Repeated Read-Aloud With Question and Answer Teaching Embedded and Repeated Read-Aloud With Executive Function Activities Embedded.,"The purpose of this study was to investigate the impact of two teaching strategies on preschoolers' oral language skills: repeated read-aloud with question and answer teaching embedded, and repeated read-aloud with executive function (EF) activities embedded. A quasi-experimental pretest-posttest design was employed. Children ranging in age from 4 years 6 months to 6 years and 4 months participated in the study ( n  = 53). They were recruited from preschools in Taitung, Taiwan, randomly assigned to the three study groups. 36 children were divided and assigned to the two experimental groups (question and answer teaching group and EF group), while the remaining 17, to the control group. The participating preservice teachers attended 32 h of training which included the theory, practice, and outcome evaluation measure for the teaching strategies implemented. The intervention spanned 2 months. Oral language tests (curriculum-based receptive vocabulary, inferential comprehension, and oral comprehension) were administered before and after the intervention. The findings revealed that both experimental groups positively impacted participants' receptive vocabulary and oral comprehension when compared with the control group, although the performances between the two experimental groups did not differ significantly. For inferential comprehension, there was no statistically significant difference across the three groups. Implications of the study findings are discussed and potential topics for future research proposed.",2019,"The findings revealed that both experimental groups positively impacted participants' receptive vocabulary and oral comprehension when compared with the control group, although the performances between the two experimental groups did not differ significantly.","['They were recruited from preschools in Taitung, Taiwan', ""Preschoolers' Oral Language Skills"", '36 children', ""preschoolers' oral language skills"", 'Children ranging in age from 4 years 6 months to 6 years and 4 months participated in the study ( n  = 53']","['read-aloud with question and answer teaching embedded, and repeated read-aloud with executive function (EF) activities embedded', 'Read-Aloud With Question and Answer Teaching Embedded and Repeated Read-Aloud']","['Oral language tests (curriculum-based receptive vocabulary, inferential comprehension, and oral comprehension', 'receptive vocabulary and oral comprehension']","[{'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0023016', 'cui_str': 'Language Tests'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",36.0,0.0145439,"The findings revealed that both experimental groups positively impacted participants' receptive vocabulary and oral comprehension when compared with the control group, although the performances between the two experimental groups did not differ significantly.","[{'ForeName': 'Hsin Ying', 'Initials': 'HY', 'LastName': 'Chien', 'Affiliation': 'Department of Early Childhood Education, National Taitung University, Taitung, Taiwan.'}]",Frontiers in psychology,['10.3389/fpsyg.2019.02932']
1960,32037583,Effectiveness of virtual patients in teaching clinical decision-making skills to dental students.,"OBJECTIVES


The aim of this study was to investigate the effect of virtual patient-based training on the clinical decision-making ability of dental students.
METHODS


This quasi-experimental study with pretest and posttest design was conducted on 76 (2015 admitted) dental students of Shiraz Dental School in 2018-2019. The study samples were randomly divided into 2 groups: intervention (web-based virtual patient training = 36) and control (face-to-face case-based training, n = 40). The data collection tools in this study included a questionnaire consisting of 2 sections: demographic information and procedural knowledge. The key-feature test was used to measure procedural knowledge and problem-solving ability in students. Content validity was confirmed by 7 faculty members. Statistical analysis was carried out using SPSS Statistics version 23.0. Descriptive statistics were used to describe the samples, Independent-t test was used to compare the scores between the 2 groups, and repeated measures ANOVA was used to assess the effect of time on the training provided. P < 0.05 was considered as the acceptable significance level.
RESULTS


The mean clinical-decision-making score in the intervention group (11.3 ± 88.88) was more than the control group (8.2 ± 45.54) in Posttest 1 (1 week after intervention), and the difference was statistically significant (P < 0.001). Besides, the scores in the control group (8.2 ± 45.54) rose more significantly than the intervention group (11.3 ± 0.86) in Posttest 2 (1 month after intervention) (P < 0.001).
CONCLUSION


The results of the present research showed that application of virtual patient (VP)-based training can improve learning and clinical decision-making ability of dental students. Moreover, group discussions in physical classrooms should be held alongside VP programs in order to ensure the maximum retention of the topics learned.",2020,"Besides, the scores in the control group (8.2 ± 45.54) rose more significantly than the intervention group (11.3 ± 0.86) in Posttest 2 (1 month after intervention)","['virtual patients in teaching clinical decision-making skills to dental students', '76 (2015 admitted) dental students of Shiraz Dental School in 2018-2019', 'students', 'dental students']","['virtual patient (VP)-based training', 'intervention (web-based virtual patient training\xa0=\xa036) and control (face-to-face case-based training, n\xa0=\xa040', 'virtual patient-based training']","['mean clinical-decision-making score', 'Content validity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}, {'cui': 'C0038493', 'cui_str': 'Students, Dental'}, {'cui': 'C0036376', 'cui_str': 'Schools, Dental'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}]",,0.017891,"Besides, the scores in the control group (8.2 ± 45.54) rose more significantly than the intervention group (11.3 ± 0.86) in Posttest 2 (1 month after intervention)","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mardani', 'Affiliation': 'Oral and Dental Disease Research Center, Department of Oral and Maxillofacial Medicine, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Cheraghian', 'Affiliation': 'School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Soheyl Khaje', 'Initials': 'SK', 'LastName': 'Naeeni', 'Affiliation': 'School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Zarifsanaiey', 'Affiliation': 'Virtual School, and Center of Excellence for e-Learning in Medical Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of dental education,['10.1002/jdd.12045']
1961,32030454,Can lavender oil inhalation help to overcome dental anxiety and pain in children? A randomized clinical trial.,"Aromatherapy with essential oils can be used to relieve children. The aim of this study was to evaluate the correlations between psychological and physiologic findings after lavender oil inhalation among children assigned to undergo tooth extraction. A total of 126 children aged between 6 and 12 years were enrolled in the study. The groups were randomly divided into control and lavender groups. The lavender group inhaled 100% lavender oil for 3 min before the interventions, the control group received no prior application. Psychological assessments were made using face image scale (FIS), Face, Legs, Activity, Cry, Consolability (FLACC) and Wong-Baker pain rating scale (WBS). Physiologic changes were assessed using vital signs evaluations. All parameters were noted prior to applications, after inhalation, anesthesia injection, and tooth extraction. The lavender group showed significant lower anxiety and pain scores after tooth extraction (p < 0.05). Significantly lower levels of blood pressures and a significant pulse rate drop were found after inhalation in the lavender group. A statistically significant increase in heart rate was observed after anesthesia injection and tooth extraction in the control group (p < 0.05).Conclusion: Lavender oil can be preferred as a treatment of choice in routine pediatric dentistry.Trial registration number: NCT04115891 (Lavender Oil Inhalation Help to Overcome Dental Anxiety Among Children)What is Known:• Dental anxiety is the most common factor that causes children to have difficulty with the dentist and their parents during treatment.• Aromatherapy with essential oils can be used to relieve children.What is New:• Aromatherapy with lavender oil relieves the child by reducing the level of anxiety and facilitates dental treatment.• During surgical procedures such as local anesthesia and tooth extraction, lavender oil inhalation decreases pain levels of children.",2020,A statistically significant increase in heart rate was observed after anesthesia injection and tooth extraction in the control group (p < 0.05).Conclusion: Lavender oil can be preferred as a treatment of choice in routine pediatric dentistry.,"['children', '126 children aged between 6 and 12\xa0years were enrolled in the study', 'children assigned to undergo tooth extraction']","['lavender group inhaled 100% lavender oil', 'Children)What', 'lavender oil inhalation', 'Aromatherapy with essential oils', 'Aromatherapy with lavender oil']","['Dental Anxiety', 'heart rate', 'dental anxiety and pain', 'level of anxiety and facilitates dental treatment.•', 'blood pressures', 'anxiety and pain scores', 'face image scale (FIS), Face, Legs, Activity, Cry, Consolability (FLACC) and Wong-Baker pain rating scale (WBS', 'pain levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0040440', 'cui_str': 'Tooth Extraction'}]","[{'cui': 'C0524903', 'cui_str': 'Lavender'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0064694', 'cui_str': 'lavender oil'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0376547', 'cui_str': 'Therapy, Aroma'}, {'cui': 'C0028910', 'cui_str': 'Oils, Essential'}]","[{'cui': 'C0085380', 'cui_str': 'Fear, Dental'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0222045'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0238749', 'cui_str': 'Baker, general (occupation)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",126.0,0.0213516,A statistically significant increase in heart rate was observed after anesthesia injection and tooth extraction in the control group (p < 0.05).Conclusion: Lavender oil can be preferred as a treatment of choice in routine pediatric dentistry.,"[{'ForeName': 'Ipek', 'Initials': 'I', 'LastName': 'Arslan', 'Affiliation': 'Faculty of Dentistry, Department of Pediatric Dentistry, Recep Tayyip Erdoğan University, Rize, Turkey. sareipekarslan@gmail.com.'}, {'ForeName': 'Sema', 'Initials': 'S', 'LastName': 'Aydinoglu', 'Affiliation': 'Faculty of Dentistry, Department of Pediatric Dentistry, Recep Tayyip Erdoğan University, Rize, Turkey.'}, {'ForeName': 'Nazife Begüm', 'Initials': 'NB', 'LastName': 'Karan', 'Affiliation': 'Faculty of Dentistry, Department of Oral & Maxillofacial Surgery, Recep Tayyip Erdoğan University, Rize, Turkey.'}]",European journal of pediatrics,['10.1007/s00431-020-03595-7']
1962,31971325,Mindfetalness to increase women's awareness of fetal movements and pregnancy outcomes: a cluster-randomised controlled trial including 39 865 women.,"OBJECTIVE


To examine whether a method for raising women's awareness of fetal movements, Mindfetalness, can affect pregnancy outcomes.
DESIGN


Cluster-randomised controlled trial.
SETTING


Sixty-seven maternity clinics in Stockholm, Sweden.
POPULATION


Women with singleton pregnancy with birth from 32 weeks' gestation.
METHODS


Women registered at a clinic randomised to Mindfetalness were assigned to receive a leaflet about Mindfetalness (n = 19 639) in comparison with routine care (n = 20 226). Data were collected from a population-based register.
MAIN OUTCOME MEASURES


Apgar score <7 at 5 minutes after birth, visit to healthcare due to decrease in fetal movements. Other outcomes: Apgar score <4 at 5 minutes after birth, small-for-gestational-age and mode of delivery.
RESULTS


No difference (1.1 versus 1.1%, relative risk [RR] 1.0; 95% CI 0.8-1.2) was found between the Mindfetalness group and the Routine care group for a 5-minute Apgar score <7. Women in the Mindfetalness group contacted healthcare more often due to decreased fetal movements (6.6 versus 3.8%, RR 1.72; 95% CI 1.57-1.87). Mindfetalness was associated with a reduction of babies born small-for-gestational-age (RR 0.95, 95% CI 0.90-1.00), babies born after gestational week 41 +6  (RR 0.91, 95% CI 0.83-0.98) and caesarean sections (19.0 versus 20.0%, RR 0.95; 95% CI 0.91-0.99).
CONCLUSIONS


Mindfetalness did not reduce the number of babies born with an Apgar score <7. However, Mindfetalness was associated with the health benefits of decreased incidence of caesarean section and fewer children born small-for-gestational-age.
TWEETABLE ABSTRACT


Introducing Mindfetalness in maternity care decreased caesarean sections but had no effect on the occurrence of Apgar scores <7.",2020,"Mindfetalness was associated with a reduction of babies born small for gestational age (RR 0.95, 95% CI 0.90-1.00), babies born after gestational week 41+6 (RR 0.91, 95% CI 0.83-0.98) and caesarean sections (19.0% versus 20.0%, RR 0.95; 95% CI 0.91-0.99).
","['39\xa0865 women', 'Women registered at a clinic randomised to Mindfetalness', ""Women with singleton pregnancy with birth from 32 weeks' gestation"", 'Sixty-seven maternity clinics in Stockholm, Sweden']",['leaflet about Mindfetalness (n=19\xa0639) in comparison to routine care'],"['caesarean sections', 'reduction of babies born small for gestational age', 'fetal movements', 'Rate Ratio', 'fetal movements and pregnancy outcomes', 'number of babies born with an Apgar score', 'caesarean section']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C1274026', 'cui_str': 'Maternity clinic'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0015946', 'cui_str': 'Fetal Activity'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}]",,0.222127,"Mindfetalness was associated with a reduction of babies born small for gestational age (RR 0.95, 95% CI 0.90-1.00), babies born after gestational week 41+6 (RR 0.91, 95% CI 0.83-0.98) and caesarean sections (19.0% versus 20.0%, RR 0.95; 95% CI 0.91-0.99).
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Akselsson', 'Affiliation': ""Department of Women and Children's Health, Karolinska Institutet, Sophiahemmet University, Stockholm, Sweden.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Lindgren', 'Affiliation': ""Department of Women and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Georgsson', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet, The Swedish Red Cross University College, Stockholm, Sweden.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Pettersson', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Steineck', 'Affiliation': 'Sahlgrenska Academy, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Skokic', 'Affiliation': 'Sahlgrenska Academy, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Rådestad', 'Affiliation': 'Sophiahemmet University, Stockholm, Sweden.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16104']
1963,30822629,"""I have the right to feel safe"": Evaluation of a school-based child sexual abuse prevention program in Ecuador.","BACKGROUND


Child sexual abuse (CSA) is a complex public health problem that has lifelong implications for children's wellbeing. Interventions may provide children strategies to protect themselves against CSA, but few have been studied in Latin America.
OBJECTIVE


Evaluate the immediate and medium-term impact of a 10-week educational program on children's knowledge of CSA self-protection strategies in Ecuador.
PARTICIPANTS AND SETTINGS


Children aged 7-12 years from six public elementary schools in Ecuador were cluster-randomized to either receive the intervention between October and November 2016 (Group 1, k = 4) or between March and April 2017 (Group 2, k = 2).
METHODS


To assess CSA knowledge, a random sample of students completed a questionnaire at three time points: 1) initial: before any group received the intervention, 2) intermediate: immediately after Group 1 completed the program but before Group 2 started it, and 3) final: after Group 2 completed the program. We evaluated changes in scores using mixed linear regression models with school as a clustering variable and adjusted degrees of freedom (df = 4).
RESULTS


Pre-post effect estimates at program completion adjusted for age, sex and clustering by school were 6.5% (95% CI: 2.9, 10.0) and 6.8% (95% CI 3.0, 10.7) for Groups 1 and 2, respectively. Scores did not change among children who had not yet received the intervention at intermediate evaluation (0.94%, 95%CI: -6.0, 7.9). Children in Group 1 maintained the scores six months after the program ended.
CONCLUSIONS


The self-protection program increased and maintained CSA knowledge six months after the intervention finished.",2019,"Scores did not change among children who had not yet received the intervention at intermediate evaluation (0.94%, 95%CI: -6.0, 7.9).","['Children aged 7-12 years from six public elementary schools in Ecuador', 'Child sexual abuse (CSA', 'school-based child sexual abuse prevention program in Ecuador', ""children's knowledge of CSA self-protection strategies in Ecuador""]",['educational program'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013593', 'cui_str': 'Ecuador'}, {'cui': 'C0008062', 'cui_str': 'Molestation, Sexual, Child'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}]",[],,0.0393441,"Scores did not change among children who had not yet received the intervention at intermediate evaluation (0.94%, 95%CI: -6.0, 7.9).","[{'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Bustamante', 'Affiliation': 'Universidad San Francisco de Quito-School of Medicine, Edificio de Especialidades Médicas, Hospital de los Valles, Av. Interoceánica Km 12 ½, Cumbayá, Quito, Ecuador; University of Minnesota-School of Public Health, 420 Delaware St SE, Minneapolis, MN, 55455, USA. Electronic address: busta027@umn.edu.'}, {'ForeName': 'María Soledad', 'Initials': 'MS', 'LastName': 'Andrade', 'Affiliation': 'Fundación Azulado, Río San Pedro E4-226 y Río Chiche, El Arenal - Tumbaco, Quito, Ecuador. Electronic address: soledad.andrade@fundacionazulado.org.'}, {'ForeName': 'Caley', 'Initials': 'C', 'LastName': 'Mikesell', 'Affiliation': 'Universidad San Francisco de Quito-School of Medicine, Edificio de Especialidades Médicas, Hospital de los Valles, Av. Interoceánica Km 12 ½, Cumbayá, Quito, Ecuador. Electronic address: cmikesell@usfq.edu.ec.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Cullen', 'Affiliation': 'Universidad San Francisco de Quito-School of Medicine, Edificio de Especialidades Médicas, Hospital de los Valles, Av. Interoceánica Km 12 ½, Cumbayá, Quito, Ecuador. Electronic address: cmcullen@umich.edu.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Endara', 'Affiliation': 'Universidad San Francisco de Quito-School of Medicine, Edificio de Especialidades Médicas, Hospital de los Valles, Av. Interoceánica Km 12 ½, Cumbayá, Quito, Ecuador. Electronic address: pendara@usfq.edu.ec.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Burneo', 'Affiliation': 'Universidad San Francisco de Quito-School of Medicine, Edificio de Especialidades Médicas, Hospital de los Valles, Av. Interoceánica Km 12 ½, Cumbayá, Quito, Ecuador. Electronic address: mburneor@estud.usfq.edu.ec.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Yépez', 'Affiliation': 'Universidad San Francisco de Quito-School of Medicine, Edificio de Especialidades Médicas, Hospital de los Valles, Av. Interoceánica Km 12 ½, Cumbayá, Quito, Ecuador. Electronic address: pao.y.1993@gmail.com.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Avila Saavedra', 'Affiliation': 'Fundación Azulado, Río San Pedro E4-226 y Río Chiche, El Arenal - Tumbaco, Quito, Ecuador. Electronic address: soledad.avila@fundacionazulado.org.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Ponce', 'Affiliation': 'Fundación Azulado, Río San Pedro E4-226 y Río Chiche, El Arenal - Tumbaco, Quito, Ecuador. Electronic address: paulina.ponce@fundacionazulado.org.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Grunauer', 'Affiliation': 'Universidad San Francisco de Quito-School of Medicine, Edificio de Especialidades Médicas, Hospital de los Valles, Av. Interoceánica Km 12 ½, Cumbayá, Quito, Ecuador; Fundación Azulado, Río San Pedro E4-226 y Río Chiche, El Arenal - Tumbaco, Quito, Ecuador. Electronic address: mgrunauer@usfq.edu.ec.'}]",Child abuse & neglect,['10.1016/j.chiabu.2019.02.009']
1964,31930364,Safety and Efficacy of RimabotulinumtoxinB for Treatment of Sialorrhea in Adults: A Randomized Clinical Trial.,"Importance


RimabotulinumtoxinB (RIMA) may be preferable as an anti-sialorrhea treatment compared with current oral anticholinergic drugs in people with neurological disorders.
Objective


To assess the safety, efficacy, and tolerability of RIMA injections for the treatment of sialorrhea in adults.
Design, Setting, and Participants


This randomized, parallel, double-blind, placebo-controlled clinical trial of RIMA 2500 U and 3500 U was conducted from November 14, 2013, to January 23, 2017. A total of 249 adult patients with troublesome sialorrhea secondary to any disorder or cause were screened. Of them, 13 refused further participation in the study or were lost to follow-up and 49 did not fulfill the criteria for participation; 187 were ultimately enrolled. Patients had to have a minimum unstimulated salivary flow rate (USFR) of 0.2 g/min and a minimum Drooling Frequency and Severity Scale score of 4.
Exposures


Patients were randomized 1:1:1 to RIMA, 2500 U (n = 63); RIMA, 3500 U (n = 64); or placebo (n = 60).
Main Outcomes and Measures


Primary outcomes were the change in USFR from baseline to week 4 and the Clinical Global Impression of Change (CGI-C) at week 4. The CGI-C scores were recorded on a 7-point scale ranging from very much improved to very much worse. Adverse events were recorded throughout the trial period.
Results


Of 187 patients enrolled (147 men [78.6%]; mean [SD] age, 63.9 [13.3] years), 122 patients had Parkinson disease (65.2%), 13 (7.0%) were stroke survivors, 12 had amyotrophic lateral sclerosis (6.4%), 6 had medication-induced sialorrhea (3.2%), 4 had adult cerebral palsy (2.1%), and 30 had sialorrhea owing to other causes (16.0%). A total of 176 completed the study. Treatment with both doses of RIMA significantly reduced USFR at week 4 vs placebo (mean treatment difference, -0.30 g/min [95% CI, -0.39 to -0.21] for both doses vs placebo, P < .001). The CGI-C scores were statistically significantly improved at week 4 for both treatment groups vs placebo (-1.21 [95% CI, -1.56 to -0.87] for 2500 U, -1.14 [95% CI, -1.49 to -0.80] for 3500 U, both P < .001). Treatment benefits were seen as early as 1 week after injection and were maintained over the treatment cycle of approximately 13 weeks. The RIMA injections were well tolerated compared with placebo. The most common adverse events were self-limited mild to moderate dry mouth, dysphagia, and dental caries.
Conclusions and Relevance


Treatment with RIMA (2500 U and 3500 U) in adults was well tolerated and reduced sialorrhea, with the onset of the effect at 1 week after the injection. These data support the clinical use of RIMA in the management of sialorrhea in adults.
Trial Registration


ClinicalTrials.gov Identifier: NCT01994109.",2020,"The CGI-C scores were statistically significantly improved at week 4 for both treatment groups vs placebo (-1.21 [95% CI, -1.56 to -0.87] for 2500 U, -1.14","['187 patients enrolled (147 men [78.6%]; mean [SD] age, 63.9 [13.3] years', 'A total of 176 completed the study', '122 patients had Parkinson disease (65.2%), 13 (7.0', 'Sialorrhea in Adults', '249 adult patients with troublesome sialorrhea secondary to any disorder or cause were screened', 'Of them, 13 refused further participation in the study or were lost to follow-up and 49 did not fulfill the criteria for participation; 187 were ultimately enrolled', 'people with neurological disorders', 'sialorrhea in adults']","['RIMA', 'RIMA injections', 'RimabotulinumtoxinB', 'placebo', 'RimabotulinumtoxinB (RIMA']","['adult cerebral palsy', 'amyotrophic lateral sclerosis', 'Safety and Efficacy', 'change in USFR from baseline to week 4 and the Clinical Global Impression of Change (CGI-C', 'tolerated and reduced sialorrhea', 'Adverse events', 'safety, efficacy, and tolerability', 'CGI-C scores', 'USFR', 'minimum Drooling Frequency and Severity Scale score of 4', 'minimum unstimulated salivary flow rate (USFR']","[{'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0037036', 'cui_str': 'Hypersalivation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0027765', 'cui_str': 'Neurologic Disorders'}]","[{'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C2719430', 'cui_str': 'rimabotulinumtoxinB'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0002736', 'cui_str': 'ALS (Amyotrophic Lateral Sclerosis)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0037036', 'cui_str': 'Hypersalivation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0439819', 'cui_str': 'Unstimulated (qualifier value)'}, {'cui': 'C0429177', 'cui_str': 'Salivary flow rate (observable entity)'}]",249.0,0.347529,"The CGI-C scores were statistically significantly improved at week 4 for both treatment groups vs placebo (-1.21 [95% CI, -1.56 to -0.87] for 2500 U, -1.14","[{'ForeName': 'Stuart H', 'Initials': 'SH', 'LastName': 'Isaacson', 'Affiliation': ""Parkinson's Disease and Movement Disorder Center of Boca Raton, Boca Raton, Florida.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Ondo', 'Affiliation': 'Houston Methodist Neurological Institute, Houston, Texas.'}, {'ForeName': 'Carlayne E', 'Initials': 'CE', 'LastName': 'Jackson', 'Affiliation': 'The University of Texas Health Science Center, San Antonio.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Trosch', 'Affiliation': 'Franklin Neurology, Farmington Hills, Michigan.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Molho', 'Affiliation': ""Parkinson's Disease and Movement Disorder Center, Albany Medical Center, Albany, New York.""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pagan', 'Affiliation': 'Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lew', 'Affiliation': 'Keck School of Medicine of University of Southern California, Los Angeles.'}, {'ForeName': 'Khashayar', 'Initials': 'K', 'LastName': 'Dashtipour', 'Affiliation': 'Loma Linda University Schools of Medicine and Pharmacy, Loma Linda, California.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Clinch', 'Affiliation': 'US WorldMeds LLC, Louisville, Kentucky.'}, {'ForeName': 'Alberto J', 'Initials': 'AJ', 'LastName': 'Espay', 'Affiliation': ""James J. and Joan A. Gardner Family Center for Parkinson's Disease and Movement Disorders, University of Cincinnati, Cincinnati, Ohio.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2019.4565']
1965,32034849,STRAWB2 (Stress and Wellbeing After Childbirth): a randomised controlled trial of targeted self-help materials to prevent post-traumatic stress disorder following childbirth.,"OBJECTIVES


To test whether providing psychological self-help materials would significantly lower the incidence of post-traumatic stress disorder (PTSD) at 6-12 weeks postnatally.
DESIGN


Open-label randomised controlled trial, with blinded outcome assessment.
SETTING


Community midwifery services in two National Health Service (NHS) trusts in the North West.
SAMPLE


A cohort of 2419 women receiving normal NHS postnatal care.
METHODS


Midwives screened women for traumatic birth experience; 678 women who screened positively (28.1%) were randomly allocated to self-help with usual care (n = 336) or to usual care alone (n = 342). The self-help materials were a leaflet and online film designed to prevent the development of PTSD after trauma exposure through explaining how to manage early psychological responses.
MAIN OUTCOME MEASURE


The primary outcome was a composite of diagnostic and subdiagnostic PTSD at 6-12 weeks postnatally using the gold-standard Clinician-Administered PTSD Scale (CAPS-5) interview.
RESULTS


Of the 678 women correctly randomised plus the nine women randomised in error, 478 (70.5%) were followed up. Diagnostic or subdiagnostic PTSD rates at follow-up did not differ between groups who received self-help (26.7%, 65/243) or usual care alone (26.2%, 64/244) (intention-to-treat analysis: RR 1.02, 95% CI 0.68-1.53). Findings remained consistent in the per-protocol analysis (RR 1.04, 95% CI 0.85-1.27). Women viewed the materials very positively. There were no adverse effects. Health economic micro-costing indicated implementation would be very low cost.
CONCLUSIONS


Many women experience a traumatic birth and risk developing PTSD, but self-help strategies without professional support are insufficient and should not be routinely introduced.
TWEETABLE ABSTRACT


Self-help information alone does not reduce the number of women developing PTSD after a traumatic childbirth.",2020,"Diagnostic or sub-diagnostic PTSD rates at follow-up did not differ between groups who received self-help (26.7%, 65/243) or usual care alone (26.2%, 64/244) (ITT analysis: relative risk (RR) 1.02, 95% confidence interval (CI) 0.68 to 1.53).","['Community midwifery services in two North West NHS Trusts', '678 women who screened positive (28.1', 'Midwives screened women for traumatic birth experience', '478 of 678 (70.5%) correctly randomised women and 9 randomised in error were followed up', '2419 women receiving usual NHS postnatal care']",['self-help with usual care (n=336) or usual care alone'],"['composite of diagnostic and sub-diagnostic PTSD', 'adverse effects', 'Diagnostic or sub-diagnostic PTSD rates', 'gold standard Clinician Administered PTSD Interview (CAPS-5']","[{'cui': 'C4075525', 'cui_str': 'Community midwifery service (qualifier value)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0026083', 'cui_str': 'Midwife'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0032782', 'cui_str': 'Postpartum Care'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}]",2419.0,0.17233,"Diagnostic or sub-diagnostic PTSD rates at follow-up did not differ between groups who received self-help (26.7%, 65/243) or usual care alone (26.2%, 64/244) (ITT analysis: relative risk (RR) 1.02, 95% confidence interval (CI) 0.68 to 1.53).","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Slade', 'Affiliation': 'Department of Psychological Sciences, Institute of Health and Life Sciences, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'West', 'Affiliation': 'Department of Psychological Sciences, Institute of Health and Life Sciences, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Thomson', 'Affiliation': 'School of Community Health and Midwifery, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lane', 'Affiliation': 'Centre for Medical Statistics and Health Evaluation, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Spiby', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'R T', 'Initials': 'RT', 'LastName': 'Edwards', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Gwynedd, UK.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Charles', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Gwynedd, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Garrett', 'Affiliation': 'Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Flanagan', 'Affiliation': 'Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Treadwell', 'Affiliation': 'Birth Trauma Association, Winchester, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hayden', 'Affiliation': ""Liverpool Women's Hospital Foundation Trust, Liverpool, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Weeks', 'Affiliation': ""Department of Women's and Children's Health, University of Liverpool, Liverpool, UK.""}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16163']
1966,32022363,Long-term quality of life and cost-effectiveness of treatment of partial thickness burns: A randomized controlled trial comparing enzyme alginogel vs silver sulfadiazine (FLAM study).,"The clinical effectiveness and scar quality of the randomized controlled trial comparing enzyme alginogel with silver sulfadiazine (SSD) for treatment of partial thickness burns were previously reported. Enzyme alginogel did not lead to faster wound healing (primary outcome) or less scar formation. In the current study, the health-related quality of life (HRQoL), costs, and cost-effectiveness of enzyme alginogel compared with SSD in the treatment of partial thickness burns were studied. HRQoL was evaluated using the Burn Specific Health Scale-Brief (BSHS-B) and the EQ-5D-5L questionnaire 1 week before discharge and at 3, 6, and 12 months postburn. Costs were studied from a societal perspective (health care and nonhealth-care costs) for a follow-up period of 1 year. A cost-effectiveness analysis was performed using cost-effectiveness acceptability curves and comparing differences in societal costs and Quality Adjusted Life Years (QALYs) at 1 year postburn. Forty-one patients were analyzed in the enzyme alginogel group and 48 patients in the SSD group. None of the domains of BSHS-B showed a statistically significant difference between the treatment groups. Also, no statistically significant difference in QALYs was found between enzyme alginogel and SSD (difference -0.03; 95% confidence interval [CI], -0.09 to 0.03; P = .30). From both the health care and the societal perspective, the difference in costs between enzyme alginogel and SSD was not statistically significant: the difference in health-care costs was €3210 (95% CI, €-1247 to €7667; P = .47) and in societal costs was €3377 (95% CI €-6229 to €12 982; P = .49). The nonsignificant differences in costs and quality-adjusted life-years in favor of SSD resulted in a low probability (<25%) that enzyme alginogel is cost-effective compared to SSD. In conclusion, there were no significant differences in quality of life between both treatment groups. Enzyme alginogel is unlikely to be cost-effective compared with SSD in the treatment of partial thickness burns.",2020,Enzyme alginogel did not lead to faster wound healing (primary outcome) or less scar formation.,"['partial thickness burns', 'Forty-one patients were analysed in the enzyme alginogel group and 48 patients in the SSD group']","['enzyme alginogel with silver sulfadiazine (SSD', 'enzyme alginogel versus silver sulfadiazine']","['healthcare costs', 'costs and quality-adjusted life-years', 'quality of life', 'Burn Specific Health Scale-Brief (BSHS-B) and the EQ-5D-5L questionnaire', 'wound healing', 'health-related quality of life (HRQoL), costs and cost-effectiveness', 'scar formation', 'QALYs', 'clinical effectiveness and scar quality', 'societal costs and Quality Adjusted Life Years (QALYs', 'cost-effectiveness acceptability curves']","[{'cui': 'C0443275', 'cui_str': 'Partial thickness (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0723179', 'cui_str': 'SSD'}]","[{'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C0037134', 'cui_str': 'silver sulfadiazine'}, {'cui': 'C0723179', 'cui_str': 'SSD'}]","[{'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0034380'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0222045'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",41.0,0.0512654,Enzyme alginogel did not lead to faster wound healing (primary outcome) or less scar formation.,"[{'ForeName': 'Zjir M', 'Initials': 'ZM', 'LastName': 'Rashaan', 'Affiliation': 'Department of Surgery, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Pieta', 'Initials': 'P', 'LastName': 'Krijnen', 'Affiliation': 'Department of Surgery, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Kelly Aa', 'Initials': 'KA', 'LastName': 'Kwa', 'Affiliation': 'Department of Surgery, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Margriet E', 'Initials': 'ME', 'LastName': 'van Baar', 'Affiliation': 'Association of Dutch Burn Centres, Maasstad Hospital, Rotterdam, Netherlands.'}, {'ForeName': 'Roelf S', 'Initials': 'RS', 'LastName': 'Breederveld', 'Affiliation': 'Department of Surgery, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'M Elske', 'Initials': 'ME', 'LastName': 'van den Akker-van Marle', 'Affiliation': 'Department of Biomedical Data Sciences, Medical Decision Making, Leiden University Medical Centre, Leiden, Netherlands.'}]",Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society,['10.1111/wrr.12799']
1967,31876012,Long-term efficacy of meaning-centered group psychotherapy for cancer survivors: 2-Year follow-up results of a randomized controlled trial.,"OBJECTIVE


Meaning-centered group psychotherapy for cancer survivors (MCGP-CS) is an effective intervention to improve personal meaning, psychological well-being, and depressive symptoms until 6 months after the intervention. In this study, the long-term effects of MCGP-CS (i.e., at 1- and 2-year follow-up) on meaning, psychological well-being and posttraumatic growth were assessed, in comparison to supportive group psychotherapy (SGP) and care as usual (CAU).
METHODS


Cancer survivors (n = 170) were randomized into MCGP-CS, SGP, or CAU. Assessments were scheduled at baseline, 1 week, 3 months, 6 months, 1 year, and 2 years postintervention. Outcome measures were the Personal Meaning Profile, Ryff's Scales of Psychological Well-Being (SPWB), the Posttraumatic Growth Inventory, and their subscales. Linear mixed models (LMM) were used and results were both reported on an intention-to-treat (ITT) basis, as well as for intervention completers only.
RESULTS


LMM and post hoc analyses with Bonferroni correction revealed that MCGP-CS participants reported more improvement on positive relations (subscale of SPWB) than CAU participants of 2-year postintervention (ITT analysis, Cohen's d = .82). Completers also reported more personal growth (subscale of SPWB) after MCGP-CS than after SGP 1-year postintervention (Cohen's d = .94). No long-term effects were found on the other outcome measures.
CONCLUSIONS


In the 2 years after MCGP-CS, the short-term significant effects on personal meaning and most positive effects related to psychological well-being faded. However, MCGP-CS had a long-term positive effect on positive relations with others and on survivors' sense of personal growth.
TRIAL REGISTRATION


Netherlands Trial Register: NTR3571.",2020,In the two years after MCGP-CS the short-term significant effects on personal meaning and most positive effects related to psychological well-being faded.,"['cancer survivors (MCGP-CS', 'cancer survivors', 'Cancer survivors (n=170']","['meaning-centered group psychotherapy', 'MCGP-CS', 'Meaning-centered group psychotherapy', 'MCGP-CS, SGP or CAU', 'supportive group psychotherapy (SGP) and care as usual (CAU']","['positive relations (subscale of SPWB', ""Personal Meaning Profile (PMP), Ryff's Scales of Psychological Well-Being (SPWB), the Posttraumatic Growth Inventory (PTGI), and their subscales"", 'personal meaning', 'personal growth (subscale of SPWB']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0033971', 'cui_str': 'Group Psychotherapy'}, {'cui': 'C0444892', 'cui_str': 'CAU'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C4704809', 'cui_str': 'Posttraumatic Growth'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",,0.154505,In the two years after MCGP-CS the short-term significant effects on personal meaning and most positive effects related to psychological well-being faded.,"[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Holtmaat', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute (APH), Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'van der Spek', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute (APH), Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Lissenberg-Witte', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Breitbart', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute (APH), Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Verdonck-de Leeuw', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute (APH), Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]",Psycho-oncology,['10.1002/pon.5323']
1968,31837232,Twenty-four-hour subjective and pharmacological effects of ad-libitum electronic and combustible cigarette use among dual users.,"BACKGROUND AND AIMS


Relative pharmacological effects of e-cigarettes and cigarettes during 24 hours of ad-libitum use have not been described. In this study, 24-hour blood plasma nicotine concentrations and 48-hour subjective effects with use of cigarettes and e-cigarettes were measured among dual users.
DESIGN


Two-arm within-subject cross-over design with preferred e-cigarette or cigarette ad-libitum use over 48 hours.
SETTING


Hospital research ward in San Francisco, California, USA.
PARTICIPANTS


Thirty-six healthy dual users of e-cigarettes and cigarettes (n = 8, 25% females).
MEASUREMENTS


Twenty-four-hour blood plasma nicotine and cotinine concentrations and 48-hour self-reported nicotine withdrawal symptoms and rewarding effects.
FINDINGS


Analyses used analysis of variance (ANOVA)-based mixed models with order of product (e-cigarette or cigarette) and product type (combustible cigarette or type of e-cigarette) as fixed effects, and subject as a repeated effect. During a 24-hour period, e-cigarettes produced lower nicotine exposure than cigarettes for the majority of users, although 25% received more nicotine from e-cigarettes, which was predicted by more frequent e-cigarette use or greater dependence. Compared to cigarette smoking, nicotine exposure for variable-power tank users was similar, while cig-a-like (t (30)   = 2.71, P = 0.011, d = 0.745) and fixed-power tank users (t (30)   = 3.37, P = 0.002, d = 0.993) were exposed to less nicotine. Cigarettes were rated higher than e-cigarettes on some desirable subjective effects (e.g. psychological reward, t (322)   = 7.24 P < 0.001, d = 0.432), but withdrawal symptom reduction was comparable. No differences were found between e-cigarette types, but Bayes factors indicate that these measures were insensitive.
CONCLUSIONS


During a 24-hour period in a hospital setting in the United States, nicotine exposure for dual users of e-cigarettes and cigarettes was similar when using cigarettes or variable-power tank devices only but was lower for those using cig-a-like or fixed-power devices only. Despite lower nicotine levels, all types of e-cigarette were effective in preventing withdrawal symptoms. E-cigarettes were rated less rewarding than cigarettes.",2019,"During a 24-hour period, e-cigarettes produced lower nicotine exposure than cigarettes for the majority of users, although 25% received more nicotine from e-cigarettes, which was predicted by more frequent e-cigarette use or greater dependence.","['Thirty-six healthy dual users of e-cigarettes and cigarettes (n\xa0', 'Hospital research ward in San Francisco, California, USA']",[],"['withdrawal symptoms', '24-hour blood plasma nicotine concentrations', 'blood plasma nicotine and cotinine concentrations and 48-hour self-reported nicotine withdrawal symptoms and rewarding effects', 'withdrawal symptom reduction']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0035168'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0006754', 'cui_str': 'California'}]",[],"[{'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0028047', 'cui_str': 'Nicotine withdrawal (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",36.0,0.0290211,"During a 24-hour period, e-cigarettes produced lower nicotine exposure than cigarettes for the majority of users, although 25% received more nicotine from e-cigarettes, which was predicted by more frequent e-cigarette use or greater dependence.","[{'ForeName': 'Arit M', 'Initials': 'AM', 'LastName': 'Harvanko', 'Affiliation': 'Center for Tobacco Control Research and Education, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'St Helen', 'Affiliation': 'Center for Tobacco Control Research and Education, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Nardone', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Newton', 'Initials': 'N', 'LastName': 'Addo', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Center for Tobacco Control Research and Education, University of California, San Francisco, CA, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.14931']
1969,1916973,Role of radiotherapy in the management of primary carcinoma of the fallopian tube.,"Primary fallopian tube carcinoma is a rare neoplasm. It may be postulated that postoperative loco-regional radiotherapy is a valuable adjunctive in the overall management of the tubal carcinoma. However, we can't advocate the efficacy of this approach authentically due to a very small number of cases. A prospective controlled and randomized trial with larger patient number may yield some definite conclusions regarding it's optimal management.",1991,It may be postulated that postoperative loco-regional radiotherapy is a valuable adjunctive in the overall management of the tubal carcinoma.,['primary carcinoma of the fallopian tube'],['radiotherapy'],[],"[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]",[],,0.0327206,It may be postulated that postoperative loco-regional radiotherapy is a valuable adjunctive in the overall management of the tubal carcinoma.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Singhal', 'Affiliation': 'Department of Radiation Oncology, Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'De', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fernandes', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chander', 'Affiliation': ''}, {'ForeName': 'G K', 'Initials': 'GK', 'LastName': 'Rath', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1970,31543460,Psychosocial mediators of screen time reduction after an intervention for students from schools in vulnerable areas: A cluster-randomized controlled trial.,"OBJECTIVES


To investigate whether psychosocial variables mediate the effect of a multicomponent intervention on screen time reduction among Brazilian students from schools located in vulnerable areas.
DESIGN


A cluster-randomized controlled trial with a 4-month follow-up.
METHODS


This study was conducted with 1085 students (548 in the intervention group and 537 in the control group), aged 11-17years. The intervention strategies focused on training teachers, increasing opportunities for physical activity at school, and reducing screen time, as well as health education. The questionnaire was administered before and after intervention with questions about the amount of time spent on TV and computer/video games on weekdays and weekend days (combined screen time). The potential psychosocial mediators (attitude, self-efficacy, family and school support) were measured through validated scales. Socioeconomic status was used as control variable. Multilevel mediation analyses were conducted using a product-of-coefficients test.
RESULTS


Psychosocial factors were not mediators of the effect of the intervention on screen time. The intervention significantly improved school support for both sexes (boys: 1.307; girls: 0.759; p<0.05) and older students (1.154; p<0.001). Attitude (boys: -0.228; 11-13years: -0.133; 14-17years: -0.152; p<0.05) and self-efficacy scales (boys: -0.040; girls: -0.104; 11-13years: -0.048; 14-17years: -0.100; p<0.05) were associated with reduced screen time.
CONCLUSIONS


The intervention produced a significant improvement of school support for both sexes, as well as older students. Enhancing attitude and self-efficacy may be a useful strategy for reducing screen time among boys and students of any age groups.
TRIAL REGISTRATION


ClinicalTrials.Gov: NCT02439827. Registration date: May 3, 2015.",2020,"Enhancing attitude and self-efficacy may be a useful strategy for reducing screen time among boys and students of any age groups.
","['Brazilian students from schools located in vulnerable areas', 'boys and students of any age groups', '1085 students (548 in the intervention group and 537 in the control group), aged 11-17years', 'students from schools in vulnerable areas']",['multicomponent intervention'],"['reduced screen time', 'potential psychosocial mediators (attitude, self-efficacy, family and school support', 'self-efficacy scales', 'screen time', 'school support']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0222045'}]",,0.0285182,"Enhancing attitude and self-efficacy may be a useful strategy for reducing screen time among boys and students of any age groups.
","[{'ForeName': 'Alexsandra da Silva', 'Initials': 'ADS', 'LastName': 'Bandeira', 'Affiliation': 'Federal University of Santa Catarina, Department of Physical Education, Campus Universitário Reitor João David Ferreira Lima, Brazil. Electronic address: alebandeiraufc@gmail.com.'}, {'ForeName': 'Kelly Samara', 'Initials': 'KS', 'LastName': 'Silva', 'Affiliation': 'Federal University of Santa Catarina, Department of Physical Education, Campus Universitário Reitor João David Ferreira Lima, Brazil.'}, {'ForeName': 'João Luiz Dornelles', 'Initials': 'JLD', 'LastName': 'Bastos', 'Affiliation': 'Federal University of Santa Catarina, Department of Public Health, Campus Universitário Reitor João David Ferreira Lima, Brazil.'}, {'ForeName': 'Diego Augusto Santos', 'Initials': 'DAS', 'LastName': 'Silva', 'Affiliation': 'Federal University of Santa Catarina, Department of Physical Education, Campus Universitário Reitor João David Ferreira Lima, Brazil.'}, {'ForeName': 'Adair da Silva', 'Initials': 'ADS', 'LastName': 'Lopes', 'Affiliation': 'Federal University of Santa Catarina, Department of Physical Education, Campus Universitário Reitor João David Ferreira Lima, Brazil.'}, {'ForeName': 'Valter Cordeiro', 'Initials': 'VC', 'LastName': 'Barbosa Filho', 'Affiliation': 'Federal Institute of Education, Science and Technology of Ceará, Aracati Campus, Brazil.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2019.09.004']
1971,1743751,A pilot study of parenteral lincomycin therapy in soft tissue infections.,"From our study it is clear that lincomycin, given 300 mg intra muscularly daily in a single dose, is effective in a wide range of soft tissue infections especially those involving the head and neck region. An overall success rate of 88.8 per cent was observed in the 150 patients selected for the study. It is significant that in none of the subjects was any untoward reaction observed or reported. Hitherto all the previous systematic surveys on lincomycin appear to have been carried out on bone infections where, undoubtedly, lincomycin is highly effective. This pilot study furnishes an encouraging report on the successful treatment of soft tissue infections with parenteral lincomycin.",1991,It is significant that in none of the subjects was any untoward reaction observed or reported.,"['150 patients selected for the study', 'soft tissue infections']","['lincomycin', 'parenteral lincomycin', 'parenteral lincomycin therapy']",['overall success rate'],"[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0149778', 'cui_str': 'Soft Tissue Infection'}]","[{'cui': 'C0023726', 'cui_str': 'Lincomycin'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0150214,It is significant that in none of the subjects was any untoward reaction observed or reported.,"[{'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Greval', 'Affiliation': 'Dept. of ENT, Dayanand Medical College and Hospital Ludhiana.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Goyal', 'Affiliation': ''}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Sofat', 'Affiliation': ''}]",Indian journal of medical sciences,[]
1972,32037199,A prospective comparative study to assess the efficacy and tolerability of 2 different doses of intravesical bacillus Calmette-Guerin (BCG) in patients with non-muscle-invasive bladder cancer.,"BACKGROUND


Bacillus Calmette-Guerin (BCG) is widely used as an immunotherapeutic agent and recommended in management of non-muscle-invasive bladder cancer (NMIBC). There is no consensus on the optimal dose of the BCG. However, dose reduction has been assessed to decrease the side effects following instillation of BCG. This study compared the efficacy and safety of 80 and 120 mg doses of Sii Onco BCG (Moscow I, Russian strain) in patients with NMIBC.
METHODS


Patients with histologically confirmed, completely resected solitary or multiple Ta or T1 (with or without carcinoma in situ), grade 1 to 3 urothelial carcinoma of the bladder were included. After transurethral resection of the tumor, repeated intravesical instillations with Sii Onco BCG (80 or 120 mg) were administered, following the induction and 3 weekly maintenance schedule (at 3, 6, 9, 15, 21, 27, and 33 months). Recurrence and progression of the tumor were monitored at scheduled time intervals using cystoscopy.
RESULTS


A total of 104 eligible patients were enrolled to receive 80 mg (n = 51) dose or 120 mg dose (n = 53) of Sii Onco BCG. On completion of 3 years follow-up, recurrence-free survival rate of 84.31% and 86.79% and progression-free survival rate of 84.31% and 94.34% were observed for 80 and 120 mg groups, respectively; difference being statistically nonsignificant.
CONCLUSION


Both, 80 and 120 mg doses of Sii Onco BCG are effective and safe for prophylaxis and management of NMIBC.",2020,80 and 120 mg doses of Sii Onco BCG are effective and safe for prophylaxis and management of NMIBC.,"['patients with NMIBC', '104 eligible patients', 'patients with non-muscle-invasive bladder cancer', 'Patients with histologically confirmed, completely resected solitary or multiple Ta or T1 (with or without carcinoma in situ), grade 1 to 3 urothelial carcinoma of the bladder were included']","['intravesical bacillus Calmette-Guerin (BCG', 'Sii Onco BCG (Moscow I, Russian strain', 'Bacillus Calmette-Guerin (BCG', 'Sii Onco BCG']","['Recurrence and progression of the tumor', 'efficacy and safety', 'efficacy and tolerability', 'side effects', 'recurrence-free survival rate', 'progression-free survival rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0007099', 'cui_str': 'Carcinoma, Intraepithelial'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0007138', 'cui_str': 'Carcinoma, Transitional Cell'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1289970', 'cui_str': 'Intravesical BCG'}, {'cui': 'C0085957', 'cui_str': 'BCG'}, {'cui': 'C0026580', 'cui_str': 'Moscow'}, {'cui': 'C0337816', 'cui_str': 'Russians (ethnic group)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",104.0,0.043771,80 and 120 mg doses of Sii Onco BCG are effective and safe for prophylaxis and management of NMIBC.,"[{'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Sood', 'Affiliation': 'Department of Urology, Dr. Ram Manohar Lohia Hospital, New Delhi, India.'}, {'ForeName': 'Hitt', 'Initials': 'H', 'LastName': 'Sharma', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India. Electronic address: drhjs@seruminstitute.com.'}, {'ForeName': 'Bhuvaneshwari', 'Initials': 'B', 'LastName': 'Sharma', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Parekh', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India.'}, {'ForeName': 'Pramod', 'Initials': 'P', 'LastName': 'Pujari', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Shewale', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India.'}]",Urologic oncology,['10.1016/j.urolonc.2020.01.002']
1973,32037209,Effects of cold chemical (glutaraldehyde) versus autoclaving sterilization on the rate of coating loss of aesthetic archwires: A double-blind randomized clinical trial.,"OBJECTIVE


The effect of any sterilization methods (cold chemical, or hot) on film removal from coated archwires has not yet been investigated. Thus, we assessed it.
MATERIALS AND METHODS


This double-blind randomized clinical trial was performed on 120 observations: 40 macroscopically intact coated archwires from 4 brands were purchased (n=10 archwires/brand). Five wires from each brand underwent cold and 5 underwent hot sterilization. Wires were applied in 40 non-extractions patients at alignment phase of treatment (one month). Afterwards, 3 inter-bracket segments from each wire were examined microscopically, and the percentage of coating loss was recorded for each segment. Coating losses of the 4 brands and 2 sterilization methods were compared using a two-way ANOVA and a Welch t-test (α=0.05). Surfaces were also evaluated using scanning electron microscopy.
RESULTS


The mean surface coating loss of hot (autoclave) and cold (glutaraldehyde) sterilization methods was 25.6±28.7 and 28.1±30.8 percent respectively. The mean surface coating removal of the Ortho Organizers, American Orthodontics, SIA, and Gestenco brands were 24.1±28.4, 36.7±36.0, 23.0±24.4, and 23.6±28.0 percent, respectively. The two-way ANOVA indicated a lack of overall significant differences among wire brands (P=0.189) and between sterilization types (P=0.629). However, the interaction of sterilization and brands was significant (P=0.005).
CONCLUSIONS


Within the limitations of this 1-month clinical trial limited to 4 coated NiTi archwire brands only, the average coating removal of examined brands might not differ much, amounting to about 26% within a month. Glutaraldehyde and autoclave sterilization might not affect the average speed of coating loss in all brands, although each sterilization method might be favourable for certain brands.",2020,The mean surface coating loss of hot (autoclave) and cold (glutaraldehyde) sterilization methods was 25.6±28.7 and 28.1±30.8 percent respectively.,['120 observations: 40 macroscopically intact coated archwires from 4 brands were purchased (n=10 archwires/brand'],"['sterilization methods (cold chemical, or hot', 'Glutaraldehyde and autoclave sterilization', 'cold chemical (glutaraldehyde) versus autoclaving sterilization']","['average speed of coating loss', 'mean surface coating loss of hot (autoclave) and cold (glutaraldehyde) sterilization methods', 'percentage of coating loss', 'rate of coating loss of aesthetic archwires', 'mean surface coating removal', 'Coating losses']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}]","[{'cui': 'C0362065', 'cui_str': 'Sterilization'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C0017814', 'cui_str': 'Glutaral'}, {'cui': 'C0179177', 'cui_str': 'Autoclave, device (physical object)'}]","[{'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0362065', 'cui_str': 'Sterilization'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]",120.0,0.127952,The mean surface coating loss of hot (autoclave) and cold (glutaraldehyde) sterilization methods was 25.6±28.7 and 28.1±30.8 percent respectively.,"[{'ForeName': 'Seyed Mohammad', 'Initials': 'SM', 'LastName': 'Mousavi', 'Affiliation': 'Ahvaz Jundishapur University of Medical Sciences, Department of Orthodontics, Ahvaz, Iran.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Shamohammadi', 'Affiliation': 'Ahvaz Jundishapur University of Medical Sciences, Department of Orthodontics, Ahvaz, Iran. Electronic address: milad.shamohammadi@yahoo.com.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Moradi', 'Affiliation': 'North Khorasan University of Medical Sciences, School of Dentistry, Department of Orthodontics, Bojnurd, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Hormozi', 'Affiliation': 'Isfahan University of Medical Sciences, School of Dentistry, Dental Research Center, Department of Orthodontics, Isfahan, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Rakhshan', 'Affiliation': 'Azad University, Department of Dental Anatomy, Faculty of Dentistry, Tehran, Iran.'}]",International orthodontics,['10.1016/j.ortho.2019.12.003']
1974,31672481,Low intensity rowing with blood flow restriction over 5 weeks increases V̇O 2 max in elite rowers: A randomized controlled trial.,"OBJECTIVES


The present randomized controlled intervention study examined the effects of practical blood flow restriction (pBFR) on maximal oxygen uptake (V̇O 2 max) during low intensity rowing.
DESIGN


Thirty-one elite rowers were either assigned to the intervention (INT) or control (CON) group, using the minimization method (Strata: Gender, Age, Height, V̇O 2 max).
METHOD


While INT (n=16; 4 female, 12 male, 21.9±3.2 years, 180.4±8.7cm, 73.6±10.9kg, V̇O 2 max: 63.0±7.9ml/min/kg) used pBFR during boat- and indoor-rowing training, CON (n=15, 4 female, 11 male, 21.7±3.7 years, 180.7±8.1cm, 72.5±12.1kg, V̇O 2 max: 63.2±8.5ml/min/kg) completed the identical training without pBFR. pBFR of the lower limb was applied via customized elastic wraps. Training took place three times a week over 5 weeks (accumulated net pBFR: 60min/week; occlusion per session: 2-times 10min/session) and was used exclusively at low intensities (<2mmol/L). A spiroergometric ramp test (V̇O 2 max; 30-40W/min increase) on rowing-ergometer and one-repetition maximum test of the squat exercise (SQ1RM) was employed to assess endurance and strength capacity.
RESULTS


Significant group×time interactions (η p ²=0.26) in favor of INT were found for V̇O 2 max (+9.1±6.2%, Effect Size=1.3) compared to CON (+2.5±6.1%, ES=0.3). SQ1RM (η p ²=0.01) was not affected by the pBFR intervention.
CONCLUSIONS


This study revealed that 15 sessions of pBFR application with a cumulative total pBFR load of 5h over a 5 weeks macrocycle remarkably increased V̇O 2 max. Thus, pBFR might serve as a promising means to improve aerobic capacity in highly trained elite rowers.",2020,"RESULTS


Significant group×time interactions (η p ²=0.26) in favor of INT were found for V̇O 2 max (+9.1±6.2%, Effect Size=1.3) compared to CON (+2.5±6.1%, ES=0.3).","['Thirty-one elite rowers', 'highly trained elite rowers', 'While INT (n=16; 4 female, 12 male, 21.9±3.2 years, 180.4±8.7cm, 73.6±10.9kg, V̇O 2 max: 63.0±7.9ml/min/kg) used pBFR during boat- and indoor-rowing training, CON (n=15, 4 female, 11 male, 21.7±3.7 years, 180.7±8.1cm, 72.5±12.1kg, V̇O 2 max: 63.2±8.5ml/min/kg) completed the', 'elite rowers']","['rowing-ergometer and one-repetition maximum test of the squat exercise (SQ1RM', 'identical training without pBFR', 'intervention (INT) or control (CON', 'Low intensity rowing with blood flow restriction', 'practical blood flow restriction (pBFR']","['SQ1RM', 'aerobic capacity', 'maximal oxygen uptake (V̇O 2 max', 'cumulative total pBFR load']","[{'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0085910', 'cui_str': 'Boats'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.0219439,"RESULTS


Significant group×time interactions (η p ²=0.26) in favor of INT were found for V̇O 2 max (+9.1±6.2%, Effect Size=1.3) compared to CON (+2.5±6.1%, ES=0.3).","[{'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Held', 'Affiliation': 'Department of Intervention Research in Exercise Training, German Sport University Cologne, Germany. Electronic address: s.held@dshs-koeln.de.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Behringer', 'Affiliation': 'Institute of Sports Sciences, Goethe University Frankfurt, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Donath', 'Affiliation': 'Department of Intervention Research in Exercise Training, German Sport University Cologne, Germany.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2019.10.002']
1975,31735531,Isometric exercise and pain in patellar tendinopathy: A randomized crossover trial.,"OBJECTIVES


The aim of this study was to compare the acute effects of isometric versus dynamic resistance exercise on pain during a pain-provoking activity, and exercise-induced hypoalgesia in participants with patellar tendinopathy.
DESIGN


This study was a pre-registered randomised crossover study. Participants were blinded to the study hypothesis.
METHODS


Participants (N = 21) performed a single session of high load isometric resistance exercise or dynamic resistance exercise, in a randomised order separated by a 7-day washout period. Outcomes were assessed before, immediately after, and 45 min post-exercise. The primary outcome was pain intensity scored on a numeric pain rating scale (NRS; 0-10) during a pain-provoking single leg decline squat (SLDS). Secondary outcomes were pressure pain thresholds (PPTs) locally, distally and remotely, as well as tendon thickness.
RESULTS


There was a significant decrease in pain NRS scores (mean reduction 0.9, NRS 95%CI 0.1-1.7; p = 0.028), and increase in PPTs at the tibialis anterior muscle (mean increase 34 kPa 95%CI 9.5-58.5; p = 0.009) immediately post-exercise. These were not sustained 45 min post-exercise for pain (NRS) or PPTs (p > 0.05). There were no differences between exercise on any outcome.
CONCLUSIONS


While patients with patellar tendinopathy decreased pain during SLDS in response to resistance training, but the magnitude was small. Contraction mode may not be the most important factor in determining the magnitude of pain relieving effects. Similarly, there were only small increases in PPTs at the tibialis anterior which were not superior for isometric exercise.",2020,"There was a significant decrease in pain NRS scores (mean reduction 0.9, NRS 95%CI 0.1-1.7; p = 0.028), and increase in PPTs at the tibialis anterior muscle (mean increase 34 kPa 95%CI 9.5-58.5; p = 0.009) immediately post-exercise.","['Participants (N\u202f=\u202f21', 'participants with patellar tendinopathy', 'patellar tendinopathy']","['Isometric exercise and pain', 'isometric versus dynamic resistance exercise', 'single session of high load isometric resistance exercise or dynamic resistance exercise']","['pain NRS scores', 'pain intensity scored on a numeric pain rating scale (NRS; 0-10) during a pain-provoking single leg decline squat (SLDS', 'PPTs at the tibialis anterior muscle', 'pain during a pain-provoking activity, and exercise-induced hypoalgesia', 'pain', 'PPTs', 'pressure pain thresholds (PPTs) locally, distally and remotely, as well as tendon thickness', 'pain (NRS) or PPTs']","[{'cui': 'C1568272', 'cui_str': 'Tendinopathy'}]","[{'cui': 'C0022206', 'cui_str': 'Exercise, Isometric'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0242690', 'cui_str': 'Anterior Tibial Muscle'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0085625', 'cui_str': 'Hypoalgesia (finding)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}]",,0.239213,"There was a significant decrease in pain NRS scores (mean reduction 0.9, NRS 95%CI 0.1-1.7; p = 0.028), and increase in PPTs at the tibialis anterior muscle (mean increase 34 kPa 95%CI 9.5-58.5; p = 0.009) immediately post-exercise.","[{'ForeName': 'Sinéad', 'Initials': 'S', 'LastName': 'Holden', 'Affiliation': 'Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University, Denmark; SMI, Department of Health Science and Technology, Aalborg University, Denmark. Electronic address: siho@hst.aau.dk.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Lyng', 'Affiliation': 'Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Graven-Nielsen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Department of Health Science and Technology, Aalborg University, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Riel', 'Affiliation': 'Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University, Denmark.'}, {'ForeName': 'Jens Lykkegaard', 'Initials': 'JL', 'LastName': 'Olesen', 'Affiliation': 'Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University, Denmark.'}, {'ForeName': 'Lars Henrik', 'Initials': 'LH', 'LastName': 'Larsen', 'Affiliation': 'Department of Physiotherapy, University College of Northern Denmark, Denmark.'}, {'ForeName': 'Michael Skovdal', 'Initials': 'MS', 'LastName': 'Rathleff', 'Affiliation': 'Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University, Denmark; SMI, Department of Health Science and Technology, Aalborg University, Denmark.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2019.09.015']
1976,32037283,Brain activation and subjective anxiety during an anticipatory anxiety task is related to clinical outcome during prazosin treatment for alcohol use disorder.,"BACKGROUND


Higher levels of anxiety, negative affect, and impaired emotion regulation are associated with alcohol use disorder (AUD) and contribute to relapse and worse treatment outcomes. Prazosin, while typically used to treat post-traumatic stress disorder (PTSD) and other anxiety disorders, has shown promise for treating AUD. In order to better understand these underlying neural processes in individuals with AUD, our aims in this study were to measure brain activation during an anticipatory anxiety task before treatment to determine whether observed patterns supported previous work. We then aimed to measure the effects of prazosin on patients with AUD and explore whether greater baseline anticipatory anxiety (as measured by subjective and neural measures) predicts better treatment outcomes.
METHODS


Thirty-four individuals seeking treatment for AUD participated in a six-week placebo-controlled study of prazosin and underwent an anticipatory anxiety task during fMRI scans at baseline and three weeks. Alcohol use over six weeks was measured.
RESULTS


Greater levels of subjective anxiety and deactivation in posterior cingulate cortex (PCC) and ventromedial prefrontal cortex (vmPFC) were observed during high-threat stimuli compared to low-threat stimuli. Compared to placebo, prazosin reduced subjective anxiety to high-threat stimuli but there were no observed significant effects of prazosin on brain activation during the task. However, AUD patients with greater vmPFC deactivation during high threat relative to low threat and patients with low baseline anticipatory anxiety during the task had worse clinical outcomes on prazosin.
CONCLUSIONS


Deactivation in PCC and vmPFC to high-threat stimuli replicated previous work and shows promise for further study as a marker for AUD. Although prazosin did not affect brain activation in the regions of interest during the anticipatory anxiety task, subjective levels of anxiety and brain activation in vmPFC predicted treatment outcomes in individuals with AUD undergoing treatment with prazosin, highlighting individuals more likely to benefit from prazosin than others.",2020,"Compared to placebo, prazosin reduced subjective anxiety to high-threat stimuli but there were no observed significant effects of prazosin on brain activation during the task.","['individuals with AUD undergoing treatment with', 'individuals with AUD', 'Thirty-four individuals seeking treatment for AUD participated in a six-week', 'patients with AUD']","['prazosin and underwent an anticipatory anxiety task', 'placebo, prazosin', 'Prazosin', 'placebo', 'prazosin']","['baseline anticipatory anxiety', 'subjective anxiety', 'Brain activation and subjective anxiety', 'anticipatory anxiety task, subjective levels of anxiety and brain activation', 'brain activation', 'subjective anxiety and deactivation in posterior cingulate cortex (PCC) and ventromedial prefrontal cortex (vmPFC']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0032912', 'cui_str': 'Prazosin'}, {'cui': 'C0231397', 'cui_str': 'Anticipatory anxiety (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0231397', 'cui_str': 'Anticipatory anxiety (finding)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C3850122', 'cui_str': 'Ventral Medial Prefrontal Cortex'}]",34.0,0.0217835,"Compared to placebo, prazosin reduced subjective anxiety to high-threat stimuli but there were no observed significant effects of prazosin on brain activation during the task.","[{'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Wilcox', 'Affiliation': 'Mind Research Network, 1101 Yale Blvd. NE, Albuquerque, NM 87106, USA. Electronic address: cwilcox@mrn.org.'}, {'ForeName': 'Bryon', 'Initials': 'B', 'LastName': 'Adinoff', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390, USA; VA North Texas Health Care System, 4500 S Lancaster Rd, Dallas, TX 75216, USA; Department of Psychiatry, School of Medicine, University of Colorado, 13001 E 17th Place, Aurora, CO 80045, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Clifford', 'Affiliation': 'Department of Psychiatry, University of New Mexico, 2400 Tucker NE, Albuquerque, NM 87131, USA.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Ling', 'Affiliation': 'Mind Research Network, 1101 Yale Blvd. NE, Albuquerque, NM 87106, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology, Center on Alcoholism, Substance Abuse & Addictions, University of New Mexico, 2650 Yale Blvd. SE, Albuquerque, NM 87106, USA.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Mayer', 'Affiliation': 'Mind Research Network, 1101 Yale Blvd. NE, Albuquerque, NM 87106, USA.'}, {'ForeName': 'Kylar M', 'Initials': 'KM', 'LastName': 'Boggs', 'Affiliation': 'Mind Research Network, 1101 Yale Blvd. NE, Albuquerque, NM 87106, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Eck', 'Affiliation': 'Mind Research Network, 1101 Yale Blvd. NE, Albuquerque, NM 87106, USA; University of Southern California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bogenschutz', 'Affiliation': 'Department of Psychiatry, New York University School of Medicine, New York, NY 10016, USA.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102162']
1977,32020414,Exercise improves metformin 72-h glucose control by reducing the frequency of hyperglycemic peaks.,"PURPOSE


To determine the separated and combined effects of metformin and exercise on insulin sensitivity and free-living glycemic control in overweight individuals with prediabetes/type 2 diabetes (T2DM).
METHODS


We recruited 16 adults with BMI of 32.7 ± 4.3 kg m -2  and insulin resistance (HOMA-IR 3.2 ± 0.4) under chronic metformin treatment (1234 ± 465 g day -1 ) enrolled in a high-intensity interval training (HIIT) program. Participants underwent four 72-h experimental trials in a random-counterbalanced order: (1) maintaining their habitual metformin treatment (MET); (2) replacing metformin treatment by placebo (CON); (3) placebo plus two HIIT sessions (EX + CON), and (4) metformin plus two HIIT sessions (MET + EX). We used intermittently scanned continuous glucose monitoring (isCGM) during 72 h in every trial to obtain interstitial fluid glucose area under the curve (IFG AUC ) and the percentage of measurements over 180 mg dL -1  (% IFG PEAKS ). Insulin sensitivity was assessed on the last day of each trial with HOMA-IR index and calculated insulin sensitivity (C SI ) from intravenous glucose tolerance test.
RESULTS


IFG AUC  was lower in MET + EX and MET than in CON (P = 0.011 and P = 0.025, respectively). In addition, IFG AUC  was lower in MET + EX than in EX + CON (P = 0.044). %IFG PEAKS  were only lower in MET + EX in relation to CON (P = 0.028). HOMA-IR and C SI  were higher in CON in comparison with MET + EX (P = 0.011 and P = 0.022, respectively) and MET (P = 0.006 and P < 0.001, respectively). IFG AUC  showed a significant correlation with HOMA-IR.
CONCLUSION


Intense aerobic exercise in patients with diabetes and prediabetes under metformin treatment reduces free-living 72-h blood hyperglycemic peaks. This may help to prevent the development of cardiovascular complications associated with diabetes.",2020,%IFG PEAKS  were only lower in MET + EX in relation to CON (P = 0.028).,"['16 adults with BMI of 32.7\u2009±\u20094.3\xa0kg\xa0m -2  and insulin resistance (HOMA-IR 3.2\u2009±\u20090.4) under chronic metformin treatment (1234\u2009±\u2009465\xa0g\xa0day -1 ) enrolled in a high-intensity interval training (HIIT) program', 'patients with diabetes and prediabetes under', 'overweight individuals with prediabetes/type 2 diabetes (T2DM']","['metformin', 'metformin and exercise', 'intermittently scanned continuous glucose monitoring (isCGM', 'habitual metformin treatment (MET); (2) replacing metformin treatment by placebo (CON); (3) placebo plus two HIIT sessions (EX\u2009+\u2009CON), and (4) metformin plus two HIIT sessions (MET\u2009+\u2009EX', 'Intense aerobic exercise']","['frequency of hyperglycemic peaks', 'Insulin sensitivity', 'free-living 72-h blood hyperglycemic peaks', 'HOMA-IR and C SI', 'insulin sensitivity and free-living glycemic control', 'IFG AUC']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517759', 'cui_str': 'Four point three'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0441633'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0005768'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",16.0,0.0313619,%IFG PEAKS  were only lower in MET + EX in relation to CON (P = 0.028).,"[{'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Ortega', 'Affiliation': 'Exercise Physiology Laboratory, University of Castilla-La Mancha, 45071, Toledo, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Morales-Palomo', 'Affiliation': 'Exercise Physiology Laboratory, University of Castilla-La Mancha, 45071, Toledo, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ramirez-Jimenez', 'Affiliation': 'Exercise Physiology Laboratory, University of Castilla-La Mancha, 45071, Toledo, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moreno-Cabañas', 'Affiliation': 'Exercise Physiology Laboratory, University of Castilla-La Mancha, 45071, Toledo, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mora-Rodríguez', 'Affiliation': 'Exercise Physiology Laboratory, University of Castilla-La Mancha, 45071, Toledo, Spain. ricardo.mora@uclm.es.'}]",Acta diabetologica,['10.1007/s00592-020-01488-7']
1978,32013946,The cost of the training and supervision of community health workers to improve exclusive breastfeeding amongst mothers in a cluster randomised controlled trial in South Africa.,"BACKGROUND


Interventions targeting community health workers (CHWs) aim to optimise the delivery of health services to underserved rural areas. Whilst interventions are evaluated against their objectives, there remains limited evidence on the economic costs of these interventions, and the practicality and value of scale up. The aim of this paper is to undertake a cost analysis on a CHW training and supervision intervention using exclusive breastfeeding rates amongst mothers as an outcome measure.
METHODS


This is a retrospective cost analysis, from an implementer's perspective, of a cluster randomised controlled trial investigating the effectiveness of a continuous quality improvement (CQI) intervention aimed at CHWs providing care and support to pregnant women and women with babies aged < 1 year in South Africa.
RESULTS


One of the outcomes of the RCT revealed that the prevalence of exclusive breastfeeding (EBF) significantly improved, with the cost per mother EBF in the control and intervention arm calculated at US$760,13 and US$1705,28 respectively. The cost per additional mother practicing EBF was calculated to be US$7647, 88, with the supervision component of the intervention constituting 64% of the trial costs. In addition, women served by the intervention CHWs were more likely to have received a CHW visit and had significantly better knowledge of childcare practices.
CONCLUSION


Whilst the cost of this intervention is high, adapted interventions could potentially offer an economical alternative for achieving selected maternal and child health (MCH) outcomes. The results of this study should inform future programmes aimed at providing adapted training and supervision to CHWs with the objective of improving community-level health outcomes.",2020,"BACKGROUND


Interventions targeting community health workers (CHWs) aim to optimise the delivery of health services to underserved rural areas.","['mothers in a cluster randomised controlled trial in South Africa', 'pregnant women and women with babies aged < 1 year in South Africa', 'community health workers (CHWs']","['RCT', 'CHW training and supervision intervention', 'continuous quality improvement (CQI) intervention aimed at CHWs providing care']","['prevalence of exclusive breastfeeding (EBF', 'knowledge of childcare practices', 'cost per additional mother practicing EBF']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",,0.0449373,"BACKGROUND


Interventions targeting community health workers (CHWs) aim to optimise the delivery of health services to underserved rural areas.","[{'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'George', 'Affiliation': 'Health Economics and HIV and AIDS Research Division (HEARD), University of KwaZulu-Natal, Durban, South Africa. Georgeg@ukzn.ac.za.'}, {'ForeName': 'Takunda', 'Initials': 'T', 'LastName': 'Mudzingwa', 'Affiliation': 'Health Economics and HIV and AIDS Research Division (HEARD), University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Horwood', 'Affiliation': 'Centre for Rural Health, University of KwaZulu-Natal, Durban, South Africa.'}]",BMC health services research,['10.1186/s12913-020-4913-4']
1979,32020296,Reperfusion of Pulmonary Arteriovenous Malformations Following Embolotherapy: A Randomized Controlled Trial of Detachable Versus Pushable Coils.,"PURPOSE


To compare 1 year post-embolization reperfusion rates in pulmonary arteriovenous malformations (PAVMs) treated with the 0.035″ Interlock™ Fibered IDC™ Occlusion System coils (IDC) (Boston Scientific, Marlborough, Massachusetts) versus 0.035″ Nester coils (Cook Medical Inc., Bloomington, Indiana).
MATERIALS AND METHODS


A randomized controlled trial was performed randomizing individual PAVMs to treatment with IDC versus Nester coils at the largest hereditary hemorrhagic telangiectasia center in Canada. The primary outcome was CT evidence of reperfusion at 1 year. Secondary outcomes included periprocedural complications, fluoroscopy time and contrast volume.
RESULTS


Our study was terminated prematurely due to slow recruitment and subsequent expiration of funding. A total of 46 PAVMs in 25 patients (64% female) were included in our study; 26 randomized to Nester coils and 20 randomized to IDC. One patient was lost to follow-up. At a mean follow-up of 421.2 ± 215.7 days, no significant difference in PAVM reperfusion was detected between Nester coils and IDC (0% vs. 5.6%, p > 0.05). No major periprocedural complications were noted in either group. Fluoroscopy time (Nester: 15.0 ± 11.8 min vs. IDC 16.0 ± 5.4 min, p > 0.05) and contrast volume (Nester: 80.3 ± 36.5 ml vs. IDC 87.3 ± 51.7 ml, p > 0.05) utilized did not differ between groups.
CONCLUSION


No significant difference was detected in PAVM reperfusion rates, periprocedural complication rates, contrast volume utilization or fluoroscopy time following embolization with IDC and Nester coils.",2020,"No significant difference was detected in PAVM reperfusion rates, periprocedural complication rates, contrast volume utilization or fluoroscopy time following embolization with IDC and Nester coils.","['A total of 46 PAVMs in 25 patients (64% female', 'Pulmonary Arteriovenous Malformations', 'at the largest hereditary hemorrhagic telangiectasia center in Canada', 'pulmonary arteriovenous malformations (PAVMs']","['0.035″ Interlock™ Fibered IDC™ Occlusion System coils (IDC', 'IDC versus Nester coils', 'Embolotherapy', 'Detachable Versus Pushable Coils']","['PAVM reperfusion', 'Fluoroscopy time', 'PAVM reperfusion rates, periprocedural complication rates, contrast volume utilization or fluoroscopy time', 'periprocedural complications, fluoroscopy time and contrast volume', 'major periprocedural complications', 'CT evidence of reperfusion']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0241790', 'cui_str': 'Pulmonary arteriovenous malformation (disorder)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0039445', 'cui_str': 'Osler-Rendu-Weber Disease'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}]","[{'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1141861', 'cui_str': 'Periprocedural complication'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}]",,0.147967,"No significant difference was detected in PAVM reperfusion rates, periprocedural complication rates, contrast volume utilization or fluoroscopy time following embolization with IDC and Nester coils.","[{'ForeName': 'Sean A', 'Initials': 'SA', 'LastName': 'Kennedy', 'Affiliation': ""Department of Diagnostic Radiology, St. Michael's Hospital, University of Toronto, Toronto, Canada. sean.kennedy@medportal.ca.""}, {'ForeName': 'Marie E', 'Initials': 'ME', 'LastName': 'Faughnan', 'Affiliation': 'Li Ka Shing Knowledge Institute, Toronto, Canada.'}, {'ForeName': 'Nicholas T', 'Initials': 'NT', 'LastName': 'Vozoris', 'Affiliation': 'Li Ka Shing Knowledge Institute, Toronto, Canada.'}, {'ForeName': 'Vikramaditya', 'Initials': 'V', 'LastName': 'Prabhudesai', 'Affiliation': ""Department of Diagnostic Radiology, St. Michael's Hospital, University of Toronto, Toronto, Canada.""}]",Cardiovascular and interventional radiology,['10.1007/s00270-020-02422-8']
1980,31303390,"2 years of calorie restriction and cardiometabolic risk (CALERIE): exploratory outcomes of a multicentre, phase 2, randomised controlled trial.","BACKGROUND


For several cardiometabolic risk factors, values considered within normal range are associated with an increased risk of cardiovascular morbidity and mortality. We aimed to investigate the short-term and long-term effects of calorie restriction with adequate nutrition on these risk factors in healthy, lean, or slightly overweight young and middle-aged individuals.
METHODS


CALERIE was a phase 2, multicentre, randomised controlled trial in young and middle-aged (21-50 years), healthy non-obese (BMI 22·0-27·9 kg/m 2 ) men and women done in three clinical centres in the USA. Participants were randomly assigned (2:1) to a 25% calorie restriction diet or an ad libitum control diet. Exploratory cardiometabolic risk factor responses to a prescribed 25% calorie restriction diet for 2 years were evaluated (systolic, diastolic, and mean blood pressure; plasma lipids; high-sensitivity C-reactive protein; metabolic syndrome score; and glucose homoeostasis measures of fasting insulin, glucose, insulin resistance, and 2-h glucose, area-under-the curve for glucose, and insulin from an oral glucose tolerance test) analysed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT00427193.
FINDINGS


From May 8, 2007, to Feb 26, 2010, of 238 participants that were assessed, 218 were randomly assigned to and started a 25% calorie restriction diet (n=143, 66%) or an ad libitum control diet (n=75, 34%). Individuals in the calorie restriction group achieved a mean reduction in calorie intake of 11·9% (SE 0·7; from 2467 kcal to 2170 kcal) versus 0·8% (1·0) in the control group, and a sustained mean weight reduction of 7·5 kg (SE 0·4) versus an increase of 0·1 kg (0·5) in the control group, of which 71% (mean change in fat mass 5·3 kg [SE 0·3] divided by mean change in weight 7·5 kg [0·4]) was fat mass loss. Calorie restriction caused a persistent and significant reduction from baseline to 2 years of all measured conventional cardiometabolic risk factors, including change scores for LDL-cholesterol (p<0·0001), total cholesterol to HDL-cholesterol ratio (p<0·0001), and systolic (p<0·0011) and diastolic (p<0·0001) blood pressure. In addition, calorie restriction resulted in a significant improvement at 2 years in C-reactive protein (p=0·012), insulin sensitivity index (p<0·0001), and metabolic syndrome score (p<0·0001) relative to control. A sensitivity analysis revealed the responses to be robust after controlling for relative weight loss changes.
INTERPRETATION


2 years of moderate calorie restriction significantly reduced multiple cardiometabolic risk factors in young, non-obese adults. These findings suggest the potential for a substantial advantage for cardiovascular health of practicing moderate calorie restriction in young and middle-aged healthy individuals, and they offer promise for pronounced long-term population health benefits.
FUNDING


National Institute on Aging and National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health.",2019,"Calorie restriction caused a persistent and significant reduction from baseline to 2 years of all measured conventional cardiometabolic risk factors, including change scores for LDL-cholesterol (p<0·0001), total cholesterol to HDL-cholesterol ratio (p<0·0001), and systolic (p<0·0011) and diastolic (p<0·0001) blood pressure.","['healthy, lean, or slightly overweight young and middle-aged individuals', 'From May 8, 2007, to Feb 26, 2010, of 238 participants that were assessed, 218 were randomly assigned to and started a 25', 'young and middle-aged (21-50 years), healthy non-obese (BMI 22·0-27·9 kg/m 2 ) men and women done in three clinical centres in the USA', 'young, non-obese adults', 'young and middle-aged healthy individuals']","['calorie restriction diet', '25% calorie restriction diet or an ad libitum control diet', 'ad libitum control diet', 'calorie restriction', 'calorie restriction with adequate nutrition']","['multiple cardiometabolic risk factors', 'Exploratory cardiometabolic risk factor responses', 'conventional cardiometabolic risk factors, including change scores for LDL-cholesterol (p<0·0001), total cholesterol to HDL-cholesterol ratio (p<0·0001), and systolic (p<0·0011) and diastolic (p<0·0001) blood pressure', 'mean reduction in calorie intake', 'C-reactive protein (p=0·012), insulin sensitivity index (p<0·0001), and metabolic syndrome score (p<0·0001) relative to control', 'evaluated (systolic, diastolic, and mean blood pressure; plasma lipids; high-sensitivity C-reactive protein; metabolic syndrome score; and glucose homoeostasis measures of fasting insulin, glucose, insulin resistance, and 2-h glucose, area-under-the curve for glucose, and insulin from an oral glucose tolerance test']","[{'cui': 'C0750482', 'cui_str': 'Slightly (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipids'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]",238.0,0.0819923,"Calorie restriction caused a persistent and significant reduction from baseline to 2 years of all measured conventional cardiometabolic risk factors, including change scores for LDL-cholesterol (p<0·0001), total cholesterol to HDL-cholesterol ratio (p<0·0001), and systolic (p<0·0011) and diastolic (p<0·0001) blood pressure.","[{'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Kraus', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA; Duke Molecular Physiology Institute, Duke University School of Medicine, Durham, NC, USA. Electronic address: william.kraus@duke.edu.'}, {'ForeName': 'Manjushri', 'Initials': 'M', 'LastName': 'Bhapkar', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Huffman', 'Affiliation': 'Duke Molecular Physiology Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Carl F', 'Initials': 'CF', 'LastName': 'Pieper', 'Affiliation': 'Duke Center for Aging and Human Development, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Sai', 'Initials': 'S', 'LastName': 'Krupa Das', 'Affiliation': 'Jean Mayer, US Department of Agriculture, Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Redman', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Dennis T', 'Initials': 'DT', 'LastName': 'Villareal', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St Louis, MO, USA; Center for Translational Research on Inflammatory Diseases, Michael E DeBakey VA Medical Center, Houston, TX, USA; Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Rochon', 'Affiliation': 'Rho Federal Systems, Chapel Hill, NC, USA.'}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Roberts', 'Affiliation': 'Jean Mayer, US Department of Agriculture, Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Ravussin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'John O', 'Initials': 'JO', 'LastName': 'Holloszy', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Fontana', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St Louis, MO, USA; Department of Clinical and Experimental Sciences, Brescia University, Brescia, Italy; School of Medicine and Charles Perkins Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30151-2']
1981,32017643,Vaccine hesitancy and influenza beliefs among parents of children requiring a second dose of influenza vaccine in a season: An American Academy of Pediatrics (AAP) Pediatric Research in Office Settings (PROS) study.,"To receive adequate protection against influenza, some children 6 months through 8 y old need two doses of influenza vaccine in a given season. Currently, only half of those receiving the first dose receive a second. Our objective was to assess vaccine hesitancy and influenza disease and vaccine knowledge, attitudes, and beliefs among caregivers of children who received the first of their two needed doses. As part of a national-randomized control trial of second dose text-message influenza vaccine reminders (2017-2018 season), a telephone survey collected caregiver and index child demographic information. Each child had received the first of two needed influenza vaccine doses. Caregivers completed a measure of general vaccine hesitancy - the five-question Parent Attitudes About Childhood Vaccines Survey Tool (PACV-5) - and questions about influenza infection and vaccine. We assessed associations between participant demographic characteristics, vaccine hesitancy, and influenza beliefs and calculated the standardized proportion of caregivers endorsing each outcome using logistic regression. Analyses included responses from 256 participants from 36 primary care practices in 24 states. Some caregivers (11.7%) reported moderate/high vaccine hesitancy and many had misperceptions about influenza disease and vaccine. In multivariable models, no single variable was consistently associated with inaccurate knowledge, attitudes, and beliefs. These results demonstrate that caregivers whose children received the first dose of influenza vaccine may still be vaccine hesitant and have inaccurate influenza beliefs. Pediatricians should consider broadly addressing inaccurate beliefs and promoting vaccination even after caregivers agree to the first dose.",2020,Caregivers completed a measure of general vaccine hesitancy - the five-question Parent Attitudes,"['caregivers of children who received the first of their two needed doses', 'parents of children requiring a second dose of', '256 participants from 36 primary care practices in 24 states']","['text-message influenza vaccine reminders', 'general vaccine hesitancy - the five-question Parent Attitudes', 'influenza vaccine']","['inaccurate knowledge, attitudes, and beliefs', 'participant demographic characteristics, vaccine hesitancy, and influenza beliefs']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0152032', 'cui_str': 'Delay when starting to pass urine (finding)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]","[{'cui': 'C0443236', 'cui_str': 'Inaccurate (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0152032', 'cui_str': 'Delay when starting to pass urine (finding)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}]",,0.0425927,Caregivers completed a measure of general vaccine hesitancy - the five-question Parent Attitudes,"[{'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Nekrasova', 'Affiliation': ""Department of Pediatrics, Center for Pediatric Clinical Effectiveness & PolicyLab, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Melissa S', 'Initials': 'MS', 'LastName': 'Stockwell', 'Affiliation': 'Department of Pediatrics, Department of Population and Family Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Localio', 'Affiliation': 'Department of Biostatistics, Epidemiology & Informatics, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Shults', 'Affiliation': 'Department of Biostatistics, Epidemiology & Informatics, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Wynn', 'Affiliation': 'Department of Pediatrics, Columbia University, New York, NY, USA.'}, {'ForeName': 'Laura P', 'Initials': 'LP', 'LastName': 'Shone', 'Affiliation': 'Department of Research, American Academy of Pediatrics, Itasca, IL, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Berrigan', 'Affiliation': ""Department of Pediatrics, Center for Pediatric Clinical Effectiveness & PolicyLab, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Kolff', 'Affiliation': 'Department of Pediatrics, Department of Population and Family Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Griffith', 'Affiliation': 'Department of Research, American Academy of Pediatrics, Itasca, IL, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Johnson', 'Affiliation': ""Department of Pediatrics, Center for Pediatric Clinical Effectiveness & PolicyLab, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Torres', 'Affiliation': 'Department of Research, American Academy of Pediatrics, Itasca, IL, USA.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Opel', 'Affiliation': ""University of Washington School of Medicine and Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Fiks', 'Affiliation': ""Department of Pediatrics, Center for Pediatric Clinical Effectiveness & PolicyLab, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1707006']
1982,31876704,"Randomized, self-controlled, prospective assessment of the efficacy of mometasone furoate local application in reducing acute radiation dermatitis in patients with head and neck squamous cell carcinomas.","BACKGROUND


Acute radiation dermatitis (ARD) is a common adverse effect in patients undergoing radiotherapy. Mometasone furoate cream (MMF) was reported to significantly reduce ARD, especially in breast cancer. Clinically, ARD is more critical and more difficult to prevent in patients with head and neck squamous cell carcinoma (HNSCC) than in those with breast cancer, because a higher dose of radiotherapy is required in HNSCC cases. The aim of this study was to evaluate the effect of MMF local application on radiation dermatitis in patients with HNSCC.
METHODS


HNSCC patients scheduled for bilateral radical radiotherapy to the neck with identical radiation doses were enrolled. One side of the neck skin (test groups) of the patients were randomized to apply a thin layer of MMF once a day from the date of first radiotherapy until either 2 weeks after end of radiotherapy or until the test side skin developed ARD lesions, while the other side of neck (control groups) didn't apply any medication. The severity of ARD was evaluated weekly by using the modified radiation therapy oncology group score, pain intensity, and itch stages.
RESULTS


Forty-one patients (82 targets) were analyzed. There was a significant difference between the ARD scores on the test side and the control side. MMF reduced the stages of ARD when the radiotherapy dose was <6000 cGY (P = .01) but showed no improvement when the dose was ≥6000 cGY (P = .699). Compared to the control side, local application of MMF significantly reduced the itch and pain scores of the test side skin regardless of the radiotherapy dose and ARD stage (P < .001) during radiotherapy.
CONCLUSIONS


This study showed that MMF inunction after high-dose radiotherapy (>50 Gy) can prevent ARD, especially when the radiation dose is <6000 cGY.",2019,"Compared to the control side, local application of MMF significantly reduced the itch and pain scores of the test side skin regardless of the radiotherapy dose and ARD stage (P < .001) during radiotherapy.
","['Acute radiation dermatitis (ARD', 'patients undergoing radiotherapy', 'patients with head and neck squamous cell carcinoma (HNSCC) than in those with breast cancer', 'HNSCC patients scheduled for bilateral radical radiotherapy to the neck with identical radiation doses were enrolled', 'patients with HNSCC', 'patients with head and neck squamous cell carcinomas']","[""side of neck (control groups) didn't apply any medication"", 'Mometasone furoate cream (MMF', 'MMF local application', 'mometasone furoate local application', 'radiotherapy', 'MMF']","['acute radiation dermatitis', 'itch and pain scores', 'pain intensity, and itch stages', 'ARD scores', 'severity of ARD', 'radiation dermatitis']","[{'cui': 'C0263606', 'cui_str': 'Early radiation dermatitis (disorder)'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0221910', 'cui_str': 'Squamous Cells'}]","[{'cui': 'C0446457', 'cui_str': 'Side of neck (surface region)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0066700', 'cui_str': 'mometasone furoate'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0263606', 'cui_str': 'Early radiation dermatitis (disorder)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0034561', 'cui_str': 'Radiation-Induced Dermatitis'}]",82.0,0.03325,"Compared to the control side, local application of MMF significantly reduced the itch and pain scores of the test side skin regardless of the radiotherapy dose and ARD stage (P < .001) during radiotherapy.
","[{'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Department of Oncology, Mianyang Central Hospital, Mianyang, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Feng', 'Affiliation': ''}, {'ForeName': 'Tangzhi', 'Initials': 'T', 'LastName': 'Dai', 'Affiliation': ''}, {'ForeName': 'Fengjiao', 'Initials': 'F', 'LastName': 'Long', 'Affiliation': ''}, {'ForeName': 'Junfei', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Yuanxue', 'Initials': 'Y', 'LastName': 'Pu', 'Affiliation': ''}, {'ForeName': 'Xuhai', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'Sui', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': ''}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000018230']
1983,32013901,"Nutritional and health status of children 15 months after integrated school garden, nutrition, and water, sanitation and hygiene interventions: a cluster-randomised controlled trial in Nepal.","BACKGROUND


It has been suggested that specific interventions delivered through the education sector in low- and middle-income countries might improve children's health and wellbeing. This cluster-randomised controlled trial aimed to evaluate the effects of a school garden programme and complementary nutrition, and water, sanitation and hygiene (WASH) interventions on children's health and nutritional status in two districts of Nepal.
METHODS


The trial included 682 children aged 8-17 years from 12 schools. The schools were randomly allocated to one of three interventions: (a) school garden programme (SG; 4 schools, n = 172 children); (b) school garden programme with complementary WASH, health and nutrition interventions (SG+; 4 schools, n = 197 children); and (c) no specific intervention (control; 4 schools, n = 313 children). The same field and laboratory procedures were employed at the baseline (March 2015) and end-line (June 2016) surveys. Questionnaires were administered to evaluate WASH conditions at schools and households. Water quality was assessed using a Delagua kit. Dietary intake was determined using food frequency and 24-h recall questionnaire. Haemoglobin levels were measured using HemoCue digital device and used as a proxy for anaemia. Stool samples were subjected to a suite of copro-microscopic diagnostic methods for detection of intestinal protozoa and helminths. The changes in key indicators between the baseline and end-line surveys were analysed by mixed logistic and linear regression models.
RESULTS


Stunting was slightly lowered in SG+ (19.9 to 18.3%; p = 0.92) and in the control (19.7 to 18.9%). Anaemia slightly decreased in SG+ (33.0 to 32.0%; p < 0.01) and markedly increased in the control (22.7 to 41.3%; p < 0.01), a minor decline was found in the control (43.9 to 42.4%). Handwashing with soap before eating strongly increased in SG+ (from 74.1 to 96.9%; p = 0.01, compared to control where only a slight increase was observed from 78.0 to 84.0%). A similar observation was made for handwashing after defecation (increase from 77.2 to 99.0% in SG+ versus 78.0 to 91.9% in control, p = 0.15).
CONCLUSIONS


An integrated intervention consisting of school garden, WASH, nutrition and health components (SG+) increased children's fruit and vegetable consumption, decreased intestinal parasitic infections and improved hygiene behaviours.
TRIAL REGISTRATION


ISRCTN17968589 (date assigned: 17 July 2015).",2020,"RESULTS


Stunting was slightly lowered in SG+ (19.9 to 18.3%; p = 0.92) and in the control (19.7 to 18.9%).","['682 children aged 8-17\u2009years from 12 schools', ""children's health and nutritional status in two districts of Nepal""]","['integrated school garden, nutrition, and water, sanitation and hygiene interventions', 'school garden programme and complementary nutrition, and water, sanitation and hygiene (WASH) interventions', 'school garden programme (SG; 4 schools, n\u2009=\u2009172 children); (b) school garden programme with complementary WASH, health and nutrition interventions (SG+; 4 schools, n\u2009=\u2009197 children); and (c) no specific intervention', 'school garden, WASH, nutrition and health components (SG']","['Water quality', ""children's fruit and vegetable consumption, decreased intestinal parasitic infections and improved hygiene behaviours"", 'Haemoglobin levels', 'Stunting', 'SG', 'Anaemia']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0027689', 'cui_str': 'Federal Democratic Republic of Nepal'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4019428', 'cui_str': 'Gardens'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1547959', 'cui_str': 'Wash - dosing instruction imperative'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0597680', 'cui_str': 'Water Quality'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0030499', 'cui_str': 'Parasitic Infections'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",682.0,0.0505621,"RESULTS


Stunting was slightly lowered in SG+ (19.9 to 18.3%; p = 0.92) and in the control (19.7 to 18.9%).","[{'ForeName': 'Akina', 'Initials': 'A', 'LastName': 'Shrestha', 'Affiliation': 'Swiss Tropical and Public Health Institute, P.O. Box, CH-4002, Basel, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schindler', 'Affiliation': 'Swiss Tropical and Public Health Institute, P.O. Box, CH-4002, Basel, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Odermatt', 'Affiliation': 'Swiss Tropical and Public Health Institute, P.O. Box, CH-4002, Basel, Switzerland.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Gerold', 'Affiliation': 'Swiss Tropical and Public Health Institute, P.O. Box, CH-4002, Basel, Switzerland.'}, {'ForeName': 'Séverine', 'Initials': 'S', 'LastName': 'Erismann', 'Affiliation': 'Swiss Tropical and Public Health Institute, P.O. Box, CH-4002, Basel, Switzerland.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'School of Science, Aquatic Ecology Centre, Kathmandu University, Dhulikhel, Nepal.'}, {'ForeName': 'Rajendra', 'Initials': 'R', 'LastName': 'Koju', 'Affiliation': 'School of Medical Sciences, Kathmandu University, Dhulikhel, Nepal.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Utzinger', 'Affiliation': 'Swiss Tropical and Public Health Institute, P.O. Box, CH-4002, Basel, Switzerland.'}, {'ForeName': 'Guéladio', 'Initials': 'G', 'LastName': 'Cissé', 'Affiliation': 'Swiss Tropical and Public Health Institute, P.O. Box, CH-4002, Basel, Switzerland. gueladio.cisse@swisstph.ch.'}]",BMC public health,['10.1186/s12889-019-8027-z']
1984,31820546,Baseline features of the VICTORIA (Vericiguat Global Study in Subjects with Heart Failure with Reduced Ejection Fraction) trial.,"AIM


Describe the distinguishing features of heart failure (HF) patients with reduced ejection fraction (HFrEF) in the VICTORIA (Vericiguat Global Study in Patients with Heart Failure with Reduced Ejection Fraction) trial.
METHODS AND RESULTS


Key background characteristics were evaluated in 5050 patients randomized in VICTORIA and categorized into three cohorts reflecting their index worsening HF event. Differences within the VICTORIA population were assessed and compared with PARADIGM-HF (Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) and COMMANDER HF (A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction, or Stroke in Participants with Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure). VICTORIA patients had increased risk of mortality and rehospitalization: New York Heart Association class (40% class III), atrial fibrillation (45%), diabetes (47%), hypertension (79%) and mean estimated glomerular filtration rate of 61.5 mL/min/1.73 m 2  . Baseline standard of HF care was very good: 60% received triple therapy. Their N-terminal pro-B-type natriuretic peptide was 3377 pg/mL [interquartile range (IQR) 1992-6380]. Natriuretic peptides were 30% higher level in the 67% patients with HF hospitalization <3 months, compared to those within 3-6 months of HF hospitalization and those randomized after recent outpatient intravenous diuretic therapy. Overall the median MAGGIC (Meta-Analysis Global Group in Chronic Heart Failure) risk score in VICTORIA was 23 (IQR 18-27) as compared to the MAGGIC risk score in PARADIGM-HF of 20 (IQR 16-24).
CONCLUSIONS


VICTORIA comprises a broadly generalizable high-risk population of three unique clinical strata of worsening chronic HFrEF despite very good HF therapy. VICTORIA will establish the role of vericiguat, a soluble guanylate cyclase stimulator, in HFrEF.",2019,"VICTORIA patients had increased risk of mortality and rehospitalization: New York Heart Association class (40% class III), atrial fibrillation (45%), diabetes (47%), hypertension (79%) and mean estimated glomerular filtration rate of 61.5 mL/min/1.73 m 2  .","['Participants with Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure', '5050 patients randomized in VICTORIA and categorized into three cohorts reflecting their index worsening HF event', 'Subjects with Heart Failure with Reduced Ejection Fraction) trial', 'heart failure (HF) patients with reduced ejection fraction (HFrEF) in the VICTORIA (Vericiguat Global Study in Patients with Heart Failure with Reduced Ejection Fraction) trial']",['Rivaroxaban'],"['Natriuretic peptides', 'Risk of Death, Myocardial Infarction, or Stroke', 'risk of mortality and rehospitalization', 'glomerular filtration rate', 'atrial fibrillation']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]",5050.0,0.0885492,"VICTORIA patients had increased risk of mortality and rehospitalization: New York Heart Association class (40% class III), atrial fibrillation (45%), diabetes (47%), hypertension (79%) and mean estimated glomerular filtration rate of 61.5 mL/min/1.73 m 2  .","[{'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Charité University Medicine, German Heart Center, Berlin, Germany.'}, {'ForeName': 'Mahesh J', 'Initials': 'MJ', 'LastName': 'Patel', 'Affiliation': 'Merck & Co. Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Westerhout', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Ezekowitz', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Koglin', 'Affiliation': 'Merck & Co. Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore & Duke-National University of Singapore, Singapore.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Cardiology Department, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Roessig', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'Groningen Heart Failure Research Institute, Groningen, The Netherlands.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1664']
1985,31036503,Morbidity and mortality after lifestyle intervention for people with impaired glucose tolerance: 30-year results of the Da Qing Diabetes Prevention Outcome Study.,"BACKGROUND


Lifestyle interventions can delay the onset of type 2 diabetes in people with impaired glucose tolerance, but whether this leads subsequently to fewer complications or to increased longevity is uncertain. We aimed to assess the long-term effects of lifestyle interventions in people with impaired glucose tolerance on the incidence of diabetes, its complications, and mortality.
METHODS


The original study was a cluster randomised trial, started in 1986, in which 33 clinics in Da Qing, China, were randomly assigned to either be a control clinic or provide one of three interventions (diet, exercise, or diet plus exercise) for 6 years for 577 adults with impaired glucose tolerance who usually receive their medical care from the clinics. Subsequently, participants were followed for up to 30 years to assess the effects of intervention on the incidence of diabetes, cardiovascular disease events, composite microvascular complications, cardiovascular disease death, all-cause mortality, and life expectancy.
FINDINGS


Of the 577 participants, 438 were assigned to an intervention group and 138 to the control group (one refused baseline examination). After 30 years of follow-up, 540 (94%) of 576 participants were assessed for outcomes (135 in the control group, 405 in the intervention group). During the 30-year follow-up, compared with control, the combined intervention group had a median delay in diabetes onset of 3·96 years (95% CI 1·25 to 6·67; p=0·0042), fewer cardiovascular disease events (hazard ratio 0·74, 95% CI 0·59-0·92; p=0·0060), a lower incidence of microvascular complications (0·65, 0·45-0·95; p=0·025), fewer cardiovascular disease deaths (0·67, 0·48-0·94; p=0·022), fewer all-cause deaths (0·74, 0·61-0·89; p=0·0015), and an average increase in life expectancy of 1·44 years (95% CI 0·20-2·68; p=0·023).
INTERPRETATION


Lifestyle intervention in people with impaired glucose tolerance delayed the onset of type 2 diabetes and reduced the incidence of cardiovascular events, microvascular complications, and cardiovascular and all-cause mortality, and increased life expectancy. These findings provide strong justification to continue to implement and expand the use of such interventions to curb the global epidemic of type 2 diabetes and its consequences.
FUNDING


US Centers for Disease Control and Prevention, WHO, Chinese Center for Disease Control and Prevention, World Bank, Ministry of Public Health of the People's Republic of China, Da Qing First Hospital, China-Japan Friendship Hospital, and National Center for Cardiovascular Diseases & Fuwai Hospital.",2019,"During the 30-year follow-up, compared with control, the combined intervention group had a median delay in diabetes onset of 3·96 years (95% CI 1·25 to 6·67; p=0·0042), fewer cardiovascular disease events (hazard ratio 0·74, 95% CI 0·59-0·92; p=0·0060), a lower incidence of microvascular complications (0·65, 0·45-0·95; p=0·025), fewer cardiovascular disease deaths (0·67, 0·48-0·94; p=0·022), fewer all-cause deaths (0·74, 0·61-0·89; p=0·0015), and an average increase in life expectancy of 1·44 years (95% CI 0·20-2·68; p=0·023).
","['1986, in which 33 clinics in Da Qing, China', '577 participants', '577 adults with impaired glucose tolerance who usually receive their medical care from the clinics', 'people with impaired glucose tolerance']","['lifestyle interventions', 'control clinic or provide one of three interventions (diet, exercise, or diet plus exercise', 'lifestyle intervention']","['cardiovascular disease events', 'incidence of cardiovascular events, microvascular complications, and cardiovascular and all-cause mortality, and increased life expectancy', 'life expectancy', 'incidence of diabetes, cardiovascular disease events, composite microvascular complications, cardiovascular disease death, all-cause mortality, and life expectancy', 'median delay in diabetes onset of 3·96 years', 'cardiovascular disease deaths', 'incidence of diabetes, its complications, and mortality', 'microvascular complications', 'Morbidity and mortality']","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Glucose Intolerance'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",576.0,0.0715643,"During the 30-year follow-up, compared with control, the combined intervention group had a median delay in diabetes onset of 3·96 years (95% CI 1·25 to 6·67; p=0·0042), fewer cardiovascular disease events (hazard ratio 0·74, 95% CI 0·59-0·92; p=0·0060), a lower incidence of microvascular complications (0·65, 0·45-0·95; p=0·025), fewer cardiovascular disease deaths (0·67, 0·48-0·94; p=0·022), fewer all-cause deaths (0·74, 0·61-0·89; p=0·0015), and an average increase in life expectancy of 1·44 years (95% CI 0·20-2·68; p=0·023).
","[{'ForeName': 'Qiuhong', 'Initials': 'Q', 'LastName': 'Gong', 'Affiliation': 'Endocrinology and Cardiovascular Disease Centre, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Division of Diabetes Translation, US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Da Qing First Hospital, Da Qing, China.'}, {'ForeName': 'Jixiang', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Division of Non-Communicable Disease Control and Community Health, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'An', 'Affiliation': 'Endocrinology and Cardiovascular Disease Centre, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Endocrinology and Cardiovascular Disease Centre, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Xinxing', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Endocrinology and Cardiovascular Disease Centre, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Da Qing First Hospital, Da Qing, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Yiling J', 'Initials': 'YJ', 'LastName': 'Cheng', 'Affiliation': 'Division of Diabetes Translation, US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Gregg', 'Affiliation': 'Division of Diabetes Translation, US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Yinghua', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiology, Da Qing First Hospital, Da Qing, China.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Bennett', 'Affiliation': 'Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ, USA.'}, {'ForeName': 'Guangwei', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Endocrinology and Cardiovascular Disease Centre, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China; China-Japan Friendship Hospital, Beijing, China. Electronic address: guangwei_li45@126.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30093-2']
1986,32012319,"Effect of brain training through visual mirror feedback, action observation and motor imagery on orofacial sensorimotor variables: A single-blind randomized controlled trial.","OBJECTIVES


The main objective was to evaluate the effects of action observation (AO), visual mirror feedback (VMF) and motor imagery (MI), combined with an oro-facial exercise programme, on sensorimotor variables in asymptomatic participants.
METHODS


We designed a randomised, single-blind, controlled trial that included 52 asymptomatic participants who were randomly assigned to 4 groups, 13 to each of the VMF, MI and AO groups and 13 to the control group (CG), which only performed the exercise programme. The primary outcomes were pain pressure sensitivity and tongue muscle strength. The secondary outcomes were maximum mouth opening, tongue length and the ability to generate mental motor images. Each group underwent a 3-session intervention using their respective exercise. Measurements were performed before starting the intervention and after each of the 3 sessions (pre, mid1, mid2 and post).
RESULTS


ANOVA revealed significant changes in PPTs in the masseter muscle region in the MI and AO groups in the pre-post and mid1-post changes. ANOVA revealed significant differences in tongue muscle strength in the anterior direction only in the AO group in the pre-mid2 and pre-post changes.
CONCLUSIONS


AO and MI, in conjunction with exercise, could induce changes in PPTs for the masseter muscle. In addition, only AO produced changes in tongue muscle strength. More research is needed to determine the role of brain representation techniques in the oro-facial region and transferring this exercise to the rehabilitation setting.",2020,"ANOVA revealed significant differences in tongue muscle strength in the anterior direction only in the AO group in the pre-mid2 and pre-post changes.
","['asymptomatic participants', '52 asymptomatic participants who were randomly assigned to 4 groups, 13 to each of the VMF, MI, and AO groups and 13 to the']","['action observation (AO), visual mirror feedback (VMF), and motor imagery (MI), combined with an orofacial exercise program', '3-session intervention using their respective exercise', 'control group (CG), which only performed the exercise program', 'brain training']","['pain pressure sensitivity and tongue muscle strength', 'maximum mouth opening, tongue length, and the ability to generate mental motor images', 'tongue muscle strength']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0181868', 'cui_str': 'Mirror, device (physical object)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]",52.0,0.0680824,"ANOVA revealed significant differences in tongue muscle strength in the anterior direction only in the AO group in the pre-mid2 and pre-post changes.
","[{'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'La Touche', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Herranz-Gómez', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Destenay', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Gey-Seedorf', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Cuenca-Martínez', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Paris-Alemany', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Suso-Martí', 'Affiliation': 'Motion in Brains Research Group, Institute of Neuroscience and Sciences of the Movement (INCIMOV), Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}]",Journal of oral rehabilitation,['10.1111/joor.12942']
1987,31876726,Quadratus lumborum block versus transversus abdominis plane block for postoperative pain management after laparoscopic colorectal surgery: A randomized controlled trial.,"BACKGROUND


This study aimed to compare the quadratus lumborum block (QLB) method with transversus abdominis plane block (TAPB) for postoperative pain management in patients undergoing laparoscopic colorectal surgery.
METHODS


Seventy-four patients scheduled for laparoscopic colorectal surgery were randomly assigned into 2 groups. After surgery, patients received bilateral ultrasound-guided single-dose of QLB or TAPB. Each side was administered with 20 ml of 0.375% ropivacaine. All patients received sufentanil as patient-controlled intravenous analgesia (PCIA). Resting and moving numeric rating scale (NRS) were assessed at 2, 4, 6, 24, 48 hours postoperatively. The primary outcome measure was sufentanil consumption at predetermined time intervals after surgery.
RESULTS


Patients in the QLB group used significantly less sufentanil than TAPB group at 24 and 48 hours (P < .05), but not at 6 hours (P = .33) after laparoscopic colorectal surgery. No significant differences in NRS results were found between the two groups at rest or during movement (P > .05). Incidence of dizziness in the QLB group was lower than in TAPB group (P < .05).
CONCLUSIONS


The QLB is a more effective postoperative analgesia as it reduces sufentanil consumption compared to TAPB in patients undergoing laparoscopic colorectal surgery.",2019,"Incidence of dizziness in the QLB group was lower than in TAPB group (P < .05).
","['postoperative pain management after laparoscopic colorectal surgery', 'patients undergoing laparoscopic colorectal surgery', 'Seventy-four patients scheduled for laparoscopic colorectal surgery']","['TAPB', 'quadratus lumborum block (QLB) method with transversus abdominis plane block (TAPB', 'QLB', 'bilateral ultrasound-guided single-dose of QLB or TAPB', 'ropivacaine', 'Quadratus lumborum block versus transversus abdominis plane block', 'sufentanil']","['Resting and moving numeric rating scale (NRS', 'sufentanil consumption at predetermined time intervals after surgery', 'NRS results', 'Incidence of dizziness']","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}]","[{'cui': 'C0167914', 'cui_str': 'TAPB-H'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0578671', 'cui_str': 'Does move (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",74.0,0.188429,"Incidence of dizziness in the QLB group was lower than in TAPB group (P < .05).
","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Long', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Manjun', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Operating Rooms, The Second Affiliated Hospital of Nanchang University, Nanchang, PR China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Guohai', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Shuchun', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology.'}]",Medicine,['10.1097/MD.0000000000018448']
1988,28749822,Comparison of Hepatitis B Virus Infection in HIV-Infected and HIV-Uninfected Participants Enrolled in a Multinational Clinical Trial: HPTN 052.,"OBJECTIVE


Data comparing hepatitis B virus (HBV) infection in HIV-infected [HIV(+)], and HIV-uninfected [HIV(-)] individuals recruited into the same study are limited. HBV infection status and chronic hepatitis B (cHB) were characterized in a multinational clinical trial: HIV Prevention Trials Network (HPTN 052).
METHOD


HBV infection status at enrollment was compared between HIV(+) (N = 1241) and HIV(-) (N = 1232) from 7 HBV-endemic countries. Hepatitis B e antigen and plasma HBV DNA were determined in cHB. Median CD4, median plasma HIV RNA, and prevalence of transaminase elevation were compared in HIV(+) with and without cHB. Significance was assessed with χ, Fisher exact, and median tests.
RESULTS


Among all participants, 33.6% had HBV exposure without cHB (8.9% isolated HBV core antibody, ""HBcAb""; 24.7% HBcAb and anti-HB surface antibody positive, ""recovered""), 4.3% had cHB, 8.9% were vaccinated, and 53.5% were uninfected. Data were similar among HIV(+) and HIV(-) except for isolated HBcAb, which was more prevalent in HIV(+) than HIV(-) [10.1% vs. 7.7%, P = 0.046]. Median HBV DNA trended higher in HIV(+) than in HIV(-). In HIV(+) with cHB versus those without cHB, transaminase elevations were more prevalent (alanine aminotransferase ≤ grade 2, 12% vs. 5.2%, P = 0.037; aspartate aminotransferase ≤ grade 2, 26% vs. 6.0%, P < 0.001), CD4 trended lower, and HIV RNA was similar.
CONCLUSIONS


HBV infection status did not differ by HIV infection status. HIV co-infection was associated with isolated HBcAb and a trend of increased HBV DNA. In HIV, cHB was associated with mild transaminase elevations and a trend toward lower CD4.",2017,Median HBV DNA trended higher in HIV(+) than in HIV(-).,"['HIV-Infected and HIV-Uninfected Participants Enrolled in a Multinational Clinical Trial', 'hepatitis B virus (HBV) infection in HIV-infected [HIV']",['HIV'],"['mild transaminase elevations', 'HIV co-infection', 'HBV exposure without cHB', 'Median CD4, median plasma HIV RNA, and prevalence of transaminase elevation', 'transaminase elevations', 'CD4 trended lower, and HIV RNA', 'HBV infection status and chronic hepatitis B (cHB', 'Hepatitis B e antigen and plasma HBV DNA']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0275524', 'cui_str': 'Co-infection'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0517627', 'cui_str': 'Infection status'}, {'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}, {'cui': 'C0019167', 'cui_str': 'e Antigens'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}]",1241.0,0.110176,Median HBV DNA trended higher in HIV(+) than in HIV(-).,"[{'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Greer', 'Affiliation': '*Department of Pathology, Johns Hopkins Hospital, Baltimore, MD;†Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA;‡Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD;§FHI 360, Washington, DC;‖FHI 360, Durham, NC;¶Research Institute for Health Sciences, Chiang Mai University, Chaing Mai, Thailand;#University of North Carolina at Chapel Hill, Chapel Hill, NC;**UNC Project-Malawi, Institute for Global Health and Infectious Diseases, Lilongwe, Malawi;††YRGCARE Medical Centre, VHS, Chennai, India;‡‡College of Medicine-Johns Hopkins Project, Blantyre, Malawi;§§Instituto Nacional de Infectologia Evandro Chagas-INI-Fiocruz, Rio de Janeiro, Brazil;‖‖Hospital Geral de Nova Iguacu and Laboratorio de AIDS e Imunologia Molecular-IOC/Fiocruz, Rio de Janeiro, Brazil;¶¶Hospital Nossa Senhora da Conceição, Porto Alegre RS, Brazil;##Botswana Harvard AIDS Institute, Gaborone, Botswana;***Kenya Medical Research Institute, Kisumu, Kenya;†††Center for Disease Control, Kisumu, Kenya;‡‡‡University of the Witwatersrand, Perinatal HIV Research Unit, Soweto HPTN CRS, Soweto, South Africa;§§§University of Witwatersrand, Johannesburg, South Africa;‖‖‖Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC; and¶¶¶Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'San-San', 'Initials': 'SS', 'LastName': 'Ou', 'Affiliation': ''}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Piwowar-Manning', 'Affiliation': ''}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Forman', 'Affiliation': ''}, {'ForeName': 'Marybeth', 'Initials': 'M', 'LastName': 'McCauley', 'Affiliation': ''}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Gamble', 'Affiliation': ''}, {'ForeName': 'Cholticha', 'Initials': 'C', 'LastName': 'Ruangyuttikarn', 'Affiliation': ''}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': ''}, {'ForeName': 'Nagalingeswaran', 'Initials': 'N', 'LastName': 'Kumarasamy', 'Affiliation': ''}, {'ForeName': 'Mulinda', 'Initials': 'M', 'LastName': 'Nyirenda', 'Affiliation': ''}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Grinsztejn', 'Affiliation': ''}, {'ForeName': 'Jose Henrique', 'Initials': 'JH', 'LastName': 'Pilotto', 'Affiliation': ''}, {'ForeName': 'Natthapol', 'Initials': 'N', 'LastName': 'Kosashunhanan', 'Affiliation': ''}, {'ForeName': 'Marineide', 'Initials': 'M', 'LastName': 'Gonçalves de Melo', 'Affiliation': ''}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Makhema', 'Affiliation': ''}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Akelo', 'Affiliation': ''}, {'ForeName': 'Ravindre', 'Initials': 'R', 'LastName': 'Panchia', 'Affiliation': ''}, {'ForeName': 'Sharlaa', 'Initials': 'S', 'LastName': 'Badal-Faesen', 'Affiliation': ''}, {'ForeName': 'Ying Q', 'Initials': 'YQ', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Myron S', 'Initials': 'MS', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Eshleman', 'Affiliation': ''}, {'ForeName': 'Chloe L', 'Initials': 'CL', 'LastName': 'Thio', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Valsamakis', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000001511']
1989,31876707,"Comparison of the selected parameters of the anterior segment of the eye between femtosecond laser-assisted cataract surgery, microincision cataract surgery, and conventional phacoemulsification: A case-control study.","The purpose of our study was to compare the selected parameters of the anterior segment of the eye in patients after femtosecond laser-assisted cataract surgery (FLACS) with the results of microincision cataract surgery (MICS) and conventional phacoemulsification surgery (CPS). This single-center prospective randomized comparative observational study included 87 patients. Patients were randomly selected into group A (FLACS), group B (MICS) and group C (control group). All the surgeries were performed by the same experienced surgeon. Preoperative and postoperative parameters were evaluated: best-corrected visual acuity (BCVA), endothelial cell density (ECD), endothelial cell loss percentage (ECL%), central corneal thickness (CCT), central anterior and posterior corneal astigmatism induction, posterior corneal elevation map were measured. Intraoperative parameters: effective phacoemulsification time (EPT), balanced salt solution use (BSS use), total surgical time and suction time were analyzed. Examination was performed preoperatively and on the first, seventh day, one and six months postoperatively. The follow up period was 6 months. There was no statistically significant difference in BCVA, central anterior and posterior astigmatism induction between studied groups. The ECL% was statistically significant lower in the group A on the 7th day, 1 month and 6-months postoperatively (P < .05). The CCT was statistically significant lower in the group A and in the group B than in the group C on the 7th postoperative day (P = .002). However, in the 6 months follow-up there was no statistically significant difference in the CCT between studied groups (P = .133). We observed statistically significant difference in change of the posterior corneal elevation map at the periphery assessed within the 90° to 120°meridian range between group A, group B and group C at every timepoint postoperatively (P < .05). The EPT and BSS use were statistically significant lower whilst total surgery time was statistically significant higher in the FLACS group (P < .05). To conclude in the 6 months follow-up there was statistically significant difference found between eyes undergoing FLACS, MICS and CPS with respect to the posterior corneal elevation map assessed within the studied range, ECL%, EPT, BSS use and total surgery time. Postoperative BCVA, central anterior and posterior astigmatism induction, CCT were comparable between studied groups.",2019,The EPT and BSS use were statistically significant lower whilst total surgery time was statistically significant higher in the FLACS group (P < .05).,['87 patients'],"['Intraoperative parameters: effective phacoemulsification time (EPT), balanced salt solution', 'femtosecond laser-assisted cataract surgery (FLACS', 'microincision cataract surgery (MICS) and conventional phacoemulsification surgery (CPS', 'FLACS', 'femtosecond laser-assisted cataract surgery, microincision cataract surgery, and conventional phacoemulsification']","['total surgery time', 'BCVA, central anterior and posterior astigmatism induction', 'Postoperative BCVA, central anterior and posterior astigmatism induction, CCT', 'corrected visual acuity (BCVA), endothelial cell density (ECD), endothelial cell loss percentage (ECL%), central corneal thickness (CCT), central anterior and posterior corneal astigmatism induction, posterior corneal elevation map', 'posterior corneal elevation map assessed within the studied range, ECL%, EPT, BSS use and total surgery time', 'total surgical time and suction time', 'CCT', 'posterior corneal elevation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3653289', 'cui_str': 'Salt irrigating solutions'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C1690970', 'cui_str': 'Bimanual microincisional phacoemulsification of cataract with intraocular lens implantation'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity (observable entity)'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell count'}, {'cui': 'C0225336', 'cui_str': 'Endothelial Cells'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0339682', 'cui_str': 'Corneal astigmatism'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0039512', 'cui_str': 'Teniposide'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}]",87.0,0.0182212,The EPT and BSS use were statistically significant lower whilst total surgery time was statistically significant higher in the FLACS group (P < .05).,"[{'ForeName': 'Edyta', 'Initials': 'E', 'LastName': 'Chlasta-Twardzik', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nowińska', 'Affiliation': ''}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Wylęgała', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000018340']
1990,31096275,Cuff-assisted versus cap-assisted colonoscopy for adenoma detection: results of a randomized study.,"BACKGROUND


The adenoma detection rate (ADR) is the most important marker of colonoscopy quality. Devices to improve adenoma detection have been developed, such as the Endocuff and transparent cap. The aim of the current study was to examine whether there was a difference in ADR between Endocuff-assisted (EAC) and cap-assisted colonoscopy (CAC).
METHODS


A randomized prospective trial was conducted. Eligible patients included adults ≥ 18 years referred because of symptoms, surveillance, or colonoscopies as part of the Bowel Cancer Screening Programme (BCSP). The primary outcome measure was ADR. Secondary outcomes included mean number of adenomas, mean number of polyps, polyp detection rate, cecal intubation rate, and time to cecal intubation. Procedural measures, device removal rate, and adverse events were also recorded.
RESULTS


A total of 711 patients (51.1 % men; median age 63 years) were included, of whom 357 patients were randomized to EAC and 354 patients to CAC. In the intention-to-treat analysis, the ADR was similar in both groups: EAC 50.4 % (95 % confidence interval [CI] 45.1 - 55.7) vs. CAC 50.6 % (95 %CI 45.2 - 55.9). Similar results were obtained in the per-protocol analysis: EAC 51.6 % (95 %CI 46.2 - 57) vs. CAC 51.4 % (95 %CI 46 - 56.8). There were no differences between the two devices in ADR according to the mean number of adenomas and polyps per procedure, polyp detection rate, cecal intubation rate, and time to cecal intubation. Device removal rate and adverse events were also similar.
CONCLUSION


In this randomized study, no differences in ADR were found between Endocuff- and cap-assisted colonoscopy.",2019,"There were no differences between the two devices in ADR according to the mean number of adenomas and polyps per procedure, polyp detection rate, cecal intubation rate, and time to cecal intubation.","['adenoma detection', 'Eligible patients included adults ≥\u200a18 years referred because of symptoms, surveillance, or colonoscopies as part of the Bowel Cancer Screening Programme (BCSP', 'and 354 patients to CAC', '711 patients (51.1\u200a% men; median age 63 years) were included, of whom 357 patients']","['EAC', 'Cuff-assisted versus cap-assisted colonoscopy', 'Endocuff- and cap-assisted colonoscopy', 'Endocuff-assisted (EAC) and cap-assisted colonoscopy (CAC']","['mean number of adenomas and polyps per procedure, polyp detection rate, cecal intubation rate, and time to cecal intubation', 'Procedural measures, device removal rate, and adverse events', 'ADR', 'Device removal rate and adverse events', 'mean number of adenomas, mean number of polyps, polyp detection rate, cecal intubation rate, and time to cecal intubation']","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0346627', 'cui_str': 'Cancer of Intestines'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0752250', 'cui_str': 'Device Removal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449207', 'cui_str': 'ADR (body structure)'}]",711.0,0.308492,"There were no differences between the two devices in ADR according to the mean number of adenomas and polyps per procedure, polyp detection rate, cecal intubation rate, and time to cecal intubation.","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sola-Vera', 'Affiliation': 'Gastroenterology Department, Hospital General Universitario de Elche, Elche, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Catalá', 'Affiliation': 'Gastroenterology Department, Hospital General Universitario de Elche, Elche, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Uceda', 'Affiliation': 'Gastroenterology Department, Hospital General Universitario de Elche, Elche, Spain.'}, {'ForeName': 'María Dolores', 'Initials': 'MD', 'LastName': 'Picó', 'Affiliation': 'Gastroenterology Department, Hospital General Universitario de Elche, Elche, Spain.'}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Pérez Rabasco', 'Affiliation': 'Gastroenterology Department, Hospital General Universitario de Elche, Elche, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Sáez', 'Affiliation': 'Gastroenterology Department, Hospital General Universitario de Elche, Elche, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Jiménez', 'Affiliation': 'Gastroenterology Department, Hospital General Universitario de Elche, Elche, Spain.'}, {'ForeName': 'María Dolores', 'Initials': 'MD', 'LastName': 'Arjona', 'Affiliation': 'Gastroenterology Department, Hospital General Universitario de Elche, Elche, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Fernández', 'Affiliation': 'Gastroenterology Department, Hospital General Universitario de Elche, Elche, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Girona', 'Affiliation': 'Gastroenterology Department, Hospital General Universitario de Elche, Elche, Spain.'}, {'ForeName': 'Mariana Fe', 'Initials': 'MF', 'LastName': 'García-Sepulcre', 'Affiliation': 'Gastroenterology Department, Hospital General Universitario de Elche, Elche, Spain.'}]",Endoscopy,['10.1055/a-0901-7306']
1991,31409671,Pembrolizumab in relapsed or refractory Hodgkin lymphoma: 2-year follow-up of KEYNOTE-087.,"Programmed death-1 inhibitors are approved for patients with relapsed or refractory classic Hodgkin lymphoma (RRcHL). We present the 2-year follow-up of the phase 2 KEYNOTE-087 study of pembrolizumab in 210 patients, based on HL progression after autologous stem cell transplantation (ASCT) and subsequent brentuximab vedotin (BV; cohort 1); salvage chemotherapy and BV, with ineligibility for SCT owing to chemorefractory disease (cohort 2); and progression after SCT without BV (cohort 3). With a median follow-up of 27.6 months, the objective response rate (ORR) by blinded independent central review was 71.9% (95% CI, 65.3-77.9), the complete response rate (CRR) was 27.6%, and the partial response (PR) rate was 44.3%. Median duration of response was 16.5 months (range, 0.0+ to 27.0+ [+, no progressive disease at last assessment]) in all patients, 22.1 months in cohort 1, 11.1 months in cohort 2, and 24.4 months in cohort 3. Median progression-free survival was not reached in all patients with CR: 13.8 months (95% CI, 12.0-22.1) for patients with PR and 10.9 months (95% CI, 5.6-11.1) for patients with stable disease. Median overall survival was not reached in all patients or in any cohort. Treatment-related adverse events (TRAEs) of any grade occurred in 153 (72.9%) patients; grades 3 and 4 occurred in 25 (12.0%) patients; none resulted in death. Results confirmed effective antitumor activity, durability of response, and manageable safety of pembrolizumab monotherapy in RRcHL, regardless of prior treatment and including chemoresistant cHL. This trial was registered at www.clinicaltrials.gov as #NCT02453594.",2019,"Median progression-free survival was not reached in all patients with CR: 13.8 months (95% CI, 12.0-22.1) for patients with PR and 10.9 months (95% CI, 5.6-11.1) for patients with stable disease.","['210 patients, based on HL progression after autologous stem cell transplantation (ASCT) and subsequent brentuximab vedotin (BV; cohort 1); salvage chemotherapy and BV, with ineligibility for SCT owing to chemorefractory disease (cohort 2); and progression after SCT without BV (cohort 3', 'patients with relapsed or refractory classic Hodgkin lymphoma (RRcHL', 'relapsed or refractory Hodgkin lymphoma']","['pembrolizumab', 'Pembrolizumab']","['partial response (PR) rate', 'complete response rate (CRR', 'Median progression-free survival', 'objective response rate (ORR', 'Median overall survival', 'adverse events (TRAEs) of any grade', 'effective antitumor activity, durability of response, and manageable safety', 'Median duration of response', 'death']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C2973446', 'cui_str': 'brentuximab vedotin'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}]","[{'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",210.0,0.108828,"Median progression-free survival was not reached in all patients with CR: 13.8 months (95% CI, 12.0-22.1) for patients with PR and 10.9 months (95% CI, 5.6-11.1) for patients with stable disease.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology and Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, CA.'}, {'ForeName': 'Pier Luigi', 'Initials': 'PL', 'LastName': 'Zinzani', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, Institute of Hematology ""Seràgnoli"" University of Bologna, Bologna, Italy.'}, {'ForeName': 'Hun Ju', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Lymphoma and Myeloma, The University of Texas, MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Armand', 'Affiliation': 'Department of Medical Oncology, Dana Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Nathalie A', 'Initials': 'NA', 'LastName': 'Johnson', 'Affiliation': 'Department of Hematology, Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Brice', 'Affiliation': 'Department of Hematology-Oncology, Hopital Saint Louis, Paris, France.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Radford', 'Affiliation': 'Division of Cancer Sciences, The University of Manchester and The Christie NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Ribrag', 'Affiliation': 'Department of Drug Development and Hematology, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Molin', 'Affiliation': 'Section of Experimental and Clinical Oncology, Department of Immunology, Genetics, and Pathology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Theodoros P', 'Initials': 'TP', 'LastName': 'Vassilakopoulos', 'Affiliation': 'Department of Hematology and Bone Marrow Transplantation, General Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Tomita', 'Affiliation': 'Department of Hematology, Fujita Health University School of Medicine, Toyoake, Japan.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'von Tresckow', 'Affiliation': 'Department of Internal Medicine, University of Cologne and University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Shipp', 'Affiliation': 'Department of Medical Oncology, Dana Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Medical Oncology, Merck & Co, Inc, Kenilworth, NJ; and.'}, {'ForeName': 'Eunhee', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Medical Oncology, Merck & Co, Inc, Kenilworth, NJ; and.'}, {'ForeName': 'Akash', 'Initials': 'A', 'LastName': 'Nahar', 'Affiliation': 'Medical Oncology, Merck & Co, Inc, Kenilworth, NJ; and.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Balakumaran', 'Affiliation': 'Medical Oncology, Merck & Co, Inc, Kenilworth, NJ; and.'}, {'ForeName': 'Craig H', 'Initials': 'CH', 'LastName': 'Moskowitz', 'Affiliation': 'Department of Medicine, University of Miami Sylvester Comprehensive Cancer Center, Miami, FL.'}]",Blood,['10.1182/blood.2019000324']
1992,31923341,Effects of Supplemental Vitamin D on Bone Health Outcomes in Women and Men in the VITamin D and OmegA-3 TriaL (VITAL).,"Although supplemental vitamin D is used to promote bone health in the general population, data from randomized controlled trials (RCTs) have been inconsistent. We determined whether daily, vitamin D 3  supplementation improves bone mineral density (BMD) and/or structure. VITamin D and OmegA-3 TriaL (VITAL) is a double-blind, placebo-controlled RCT of supplemental vitamin D 3  (2000 IU/d) and/or omega-3 fatty acids (1 g/d) in 25,871 adults nationwide. This ancillary study included a subcohort of 771 participants (men ≥50 and women ≥55 years; not taking bone active medications) evaluated at baseline and at 2-year follow-up (89% retention). Total 25(OH)D levels were measured by liquid chromatography tandem mass spectrometry (Quest Diagnostics, San Juan Capistrano, CA, USA). Free 25(OH)D (FVD) levels were measured using the ELISA assay by Future Diagnostics Solutions BV (Wijchen, Netherlands). Primary endpoints were 2-year changes in areal (a) BMD at the spine, hip, and whole body determined by dual-energy X-ray absorptiometry (DXA). Secondary endpoints were 2-year changes in volumetric (v) BMD and cortical thickness at the radius and tibia assessed by peripheral quantitative computed tomography. Supplemental vitamin D 3  versus placebo had no effect on 2-year changes in aBMD at the spine (0.33% versus 0.17%; p = 0.55), femoral neck (-0.27% versus -0.68%; p = 0.16), total hip (-0.76% versus -0.95%; p = 0.23), or whole body (-0.22% versus -0.15%; p = 0.60), or on measures of bone structure. Effects did not vary by sex, race/ethnicity, body mass index, or 25(OH)D levels. Among participants with baseline FVD levels below the median (<14.2 pmol/L), there was a slight increase in spine aBMD (0.75% versus 0%; p = 0.043) and attenuation in loss of total hip aBMD (-0.42% versus -0.98%; p = 0.044) with vitamin D 3  . Whether baseline FVD levels help to identify those more likely to benefit from supplementation warrants further study. Supplemental vitamin D 3  versus placebo for 2 years in general healthy adults not selected for vitamin D insufficiency did not improve BMD or structure. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.",2020,Supplemental vitamin D 3  vs. placebo had no effect on 2-year changes in aBMD at the spine (0.33% vs. 0.17%;,"['771 participants (men ≥50 and women ≥55\u2009years; not taking bone active medications) evaluated at baseline and 2-years follow-up (89% retention', '25,871 adults nationwide', 'general healthy adults', 'Women and Men in the VITamin D and OmegA-3 TriaL (VITAL']","['VITamin D and OmegA-3 TriaL', 'omega-3 fatty acids', 'supplemental vitamin D', 'vitamin D 3  supplementation', 'Supplemental Vitamin D', 'placebo', 'Supplemental vitamin D 3  vs. placebo']","['femoral neck', '2-year changes in volumetric (v)BMD and cortical thickness at the radius and tibia assessed by peripheral quantitative computed tomography', 'sex, race/ethnicity, BMI, or 25(OH)D levels', 'BMD or structure', 'bone mineral density (BMD) and/or structure', '2-year changes in aBMD', 'Total 25(OH)D levels', 'Bone Health Outcomes', 'spine aBMD', 'total hip', '2-year changes in areal (a)BMD at the spine, hip, and whole body determined by dual-energy X-ray absorptiometry', 'attenuation in loss of total hip aBMD', 'Free 25(OH)D (FVD) levels']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0442732', 'cui_str': 'Vital (qualifier value)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0445383', 'cui_str': 'Volumetric (qualifier value)'}, {'cui': 'C1306504', 'cui_str': 'Radius (qualifier value)'}, {'cui': 'C0040184', 'cui_str': 'Tibia'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}]",771.0,0.308404,Supplemental vitamin D 3  vs. placebo had no effect on 2-year changes in aBMD at the spine (0.33% vs. 0.17%;,"[{'ForeName': 'Meryl S', 'Initials': 'MS', 'LastName': 'LeBoff', 'Affiliation': ""Division of Endocrinology, Diabetes, and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, Boston, MA, USA.""}, {'ForeName': 'Sharon H', 'Initials': 'SH', 'LastName': 'Chou', 'Affiliation': ""Division of Endocrinology, Diabetes, and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, Boston, MA, USA.""}, {'ForeName': 'Elle M', 'Initials': 'EM', 'LastName': 'Murata', 'Affiliation': ""Division of Endocrinology, Diabetes, and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, Boston, MA, USA.""}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Donlon', 'Affiliation': ""Division of Endocrinology, Diabetes, and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, Boston, MA, USA.""}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Kotler', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Bubes', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3958']
1993,31340023,Text message alerts to emergency physicians identifying potential study candidates increase clinical trial enrollment.,"Prospective enrollment of research subjects in the fast-paced emergency department (ED) is challenging. We sought to develop a software application to increase real-time clinical trial enrollment during an ED visit. The Prospective Intelligence System for Clinical Emergency Services (PISCES) scans the electronic health record during ED encounters for preselected clinical characteristics of potentially eligible study participants and notifies the treating physician via mobile phone text alerts. PISCES alerts began 3 months into a cluster randomized trial of an electronic health record-based risk stratification tool for pediatric abdominal pain in 11 Northern California EDs. We compared aggregate enrollment before (2577 eligible patients, October 2016 to December 2016) and after (12 049 eligible patients, January 2017 to January 2018) PISCES implementation. Enrollment increased from 10.8% to 21.1% following PISCES implementations (P < .001). PISCES significantly increased study enrollment and can serve as a valuable tool to assist prospective research enrollment in the ED.",2019,Enrollment increased from 10.8% to 21.1% following PISCES implementations (P < .001).,"['2577 eligible patients, October 2016 to December 2016) and after (12\xa0049 eligible patients, January 2017 to January 2018) PISCES implementation', 'pediatric abdominal pain in 11 Northern California EDs']",['electronic health record-based risk stratification tool'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]",[],2577.0,0.0650214,Enrollment increased from 10.8% to 21.1% following PISCES implementations (P < .001).,"[{'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Simon', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, California, USA.'}, {'ForeName': 'Adina S', 'Initials': 'AS', 'LastName': 'Rauchwerger', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, California, USA.'}, {'ForeName': 'Uli K', 'Initials': 'UK', 'LastName': 'Chettipally', 'Affiliation': 'Emergency Department, Kaiser Permanente South San Francisco Medical Center, South San Francisco, California, USA.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Babakhanian', 'Affiliation': 'Asolva Inc, Pasadena, California, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Vinson', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, California, USA.'}, {'ForeName': 'E Margaret', 'Initials': 'EM', 'LastName': 'Warton', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, California, USA.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Reed', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, California, USA.'}, {'ForeName': 'Anupam B', 'Initials': 'AB', 'LastName': 'Kharbanda', 'Affiliation': ""Emergency Department, Children's Hospitals and Clinics of Minnesota, Minneapolis, Minnesota, USA.""}, {'ForeName': 'Elyse O', 'Initials': 'EO', 'LastName': 'Kharbanda', 'Affiliation': 'Division of Research, HealthPartners Institute, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Dustin W', 'Initials': 'DW', 'LastName': 'Ballard', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, California, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocz118']
1994,31340042,"First-in-Human Randomized Study to Assess the Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus (RSV) Vaccine Based on Chimpanzee-Adenovirus-155 Viral Vector-Expressing RSV Fusion, Nucleocapsid, and Antitermination Viral Proteins in Healthy Adults.","BACKGROUND


Respiratory syncytial virus (RSV) disease is a major cause of infant morbidity and mortality. This Phase I, randomized, observer-blind, placebo- and active-controlled study evaluated an investigational vaccine against RSV (ChAd155-RSV) using the viral vector chimpanzee-adenovirus-155, encoding RSV fusion (F), nucleocapsid, and transcription antitermination proteins.
METHODS


Healthy 18-45-year-old adults received ChAd155-RSV, a placebo, or an active control (Bexsero) at Days (D) 0 and 30. An escalation from a low dose (5 × 109 viral particles) to a high dose (5 × 1010 viral particles) occurred after the first 16 participants. Endpoints were solicited/unsolicited and serious adverse events (SAEs), biochemical/hematological parameters, cell-mediated immunogenicity by enzyme-linked immunospot, functional neutralizing antibodies, anti RSV-F immunoglobin (Ig) G, and ChAd155 neutralizing antibodies.
RESULTS


There were 7 participants who received the ChAd155-RSV low dose, 31 who received the ChAd155-RSV high dose, 19 who received the placebo, and 15 who received the active control. No dose-related toxicity or attributable SAEs at the 1-year follow-up were observed. The RSV-A neutralizing antibodies geometric mean titer ratios (post/pre-immunization) following a high dose were 2.6 (D30) and 2.3 (D60). The ratio of the fold-rise (D0 to D30) in anti-F IgG over the fold-rise in RSV-A-neutralizing antibodies was 1.01. At D7 after the high dose of the study vaccine, the median frequencies of circulating B-cells secreting anti-F antibodies were 133.3/106 (IgG) and 16.7/106 (IgA) in peripheral blood mononuclear cells (PBMCs). The median frequency of RSV-F-specific interferon γ-secreting T-cells after a ChAd155-RSV high dose was 108.3/106 PBMCs at D30, with no increase after the second dose.
CONCLUSIONS


In adults previously naturally exposed to RSV, ChAd155-RSV generated increases in specific humoral and cellular immune responses without raising significant safety concerns.
CLINICAL TRIALS REGISTRATION


NCT02491463.",2020,"Median frequency of RSV-F specific IFN-γ secreting T-cells after ChAd155-RSV high dose was 108.3/106 PBMCs at D30, with no increase after the second dose.
","['Healthy 18-45-year-old adults', 'healthy adults']","['ChAd155-RSV, placebo or active control (Bexsero), at day (D) 0 and D30', 'placebo', 'investigational respiratory syncytial virus (RSV) vaccine', 'investigational vaccine against RSV (ChAd155-RSV) using the viral vector chimpanzee-adenovirus-155, encoding RSV fusion (F), nucleocapsid and transcription anti-termination proteins']","['safety and immunogenicity', 'median frequencies of circulating B-cells secreting anti-F antibodies', 'solicited/unsolicited and serious adverse events (SAEs), biochemical/hematological parameters, cell-mediated immunogenicity by ELISpot, functional neutralizing antibody , anti RSV-F-IgG, and ChAd155 neutralizing antibodies', 'specific humoral and cellular immune response', 'Median frequency of RSV-F specific IFN-γ secreting T-cells']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0887894', 'cui_str': 'RSV Vaccines'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0442335', 'cui_str': 'Vectors (qualifier value)'}, {'cui': 'C0085999', 'cui_str': 'Genus Pan (organism)'}, {'cui': 'C0001483', 'cui_str': 'Adenoviruses'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0178774', 'cui_str': 'Nucleocapsid'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0313107', 'cui_str': 'Blood group antibody f (substance)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0920508', 'cui_str': 'ELISPOT'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1817908', 'cui_str': 'Cellular Immune Response'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}]",7.0,0.287577,"Median frequency of RSV-F specific IFN-γ secreting T-cells after ChAd155-RSV high dose was 108.3/106 PBMCs at D30, with no increase after the second dose.
","[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Cicconi', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}, {'ForeName': 'Esha', 'Initials': 'E', 'LastName': 'Sarkar', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Silva-Reyes', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Klenerman', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'de Lara', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hutchings', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moris', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Janssens', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Laurence A', 'Initials': 'LA', 'LastName': 'Fissette', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Picciolato', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Leach', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gonzalez-Lopez', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Dieussaert', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Snape', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz653']
1995,31340872,Women with a low-satiety phenotype show impaired appetite control and greater resistance to weight loss.,"This trial compared weight loss outcomes over 14 weeks in women showing low- or high-satiety responsiveness (low- or high-satiety phenotype (LSP, HSP)) measured by a standardised protocol. Food preferences and energy intake (EI) after low and high energy-density (LED, HED) meals were also assessed. Ninety-six women (n 52 analysed; 41·24 (SD 12·54) years; 34·02 (sd 3·58) kg/m2) engaged in one of two weight loss programmes underwent LED and HED laboratory test days during weeks 3 and 12. Preferences for LED and HED food (Leeds Food Preference Questionnaire) and ad libitum evening meal and snack EI were assessed in response to equienergetic LED and HED breakfasts and lunches. Weekly questionnaires assessed control over eating and ease of adherence to the programme. Satiety quotients based on subjective fullness ratings post LED and HED breakfasts determined LSP (n 26) and HSP (n 26) by tertile splits. Results showed that the LSP lost less weight and had smaller reductions in waist circumference compared with HSP. The LSP showed greater preferences for HED foods, and under HED conditions, consumed more snacks (kJ) compared with HSP. Snack EI did not differ under LED conditions. LSP reported less control over eating and reported more difficulty with programme adherence. In conclusion, low-satiety responsiveness is detrimental for weight loss. LED meals can improve self-regulation of EI in the LSP, which may be beneficial for longer-term weight control.",2019,Snack EI did not differ under LED-conditions.,"['Ninety-six women (n = 52 analysed; 41.24 ± 12.54 years; 34.02 ± 3.58 kg/m2) engaged in one of two weight loss programs underwent LED and HED laboratory-test days during weeks 3 and 12', 'women showing low or high satiety responsiveness [low or high satiety phenotype (LSP, HSP']","['LED and HED-foods', 'LSP', 'LED meals', 'ad libitum evening meal and snack energy intake']","['Food preferences and energy intake after low and high energy density (LED, HED) meals', 'appetite control and greater resistance to weight loss', 'waist circumference', 'Weekly questionnaires assessed control over eating and ease of adherence']","[{'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0022885', 'cui_str': 'Laboratory test (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0585040', 'cui_str': 'Dinnertime'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}]","[{'cui': 'C0016483', 'cui_str': 'Food Preferences'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0003622', 'cui_str': 'Appetite Regulation'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",96.0,0.118322,Snack EI did not differ under LED-conditions.,"[{'ForeName': 'Nicola J', 'Initials': 'NJ', 'LastName': 'Buckland', 'Affiliation': 'Department of Psychology, University of Sheffield, Cathedral Court, 1 Vicar Lane, Sheffield S1 2LT, UK.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Camidge', 'Affiliation': 'Human Appetite Research Unit, Appetite Control and Energy Balance Group, School of Psychology, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Croden', 'Affiliation': 'Human Appetite Research Unit, Appetite Control and Energy Balance Group, School of Psychology, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Myers', 'Affiliation': 'Sheffield Hallam University, Centre for Sport and Exercise Science, Collegiate Hall, Sheffield S10 2BP, UK.'}, {'ForeName': 'Jacquelynne H', 'Initials': 'JH', 'LastName': 'Lavin', 'Affiliation': 'Nutrition and Research Department, Slimming World, Alfreton, Derbyshire DE55 4RF, UK.'}, {'ForeName': 'R James', 'Initials': 'RJ', 'LastName': 'Stubbs', 'Affiliation': 'Human Appetite Research Unit, Appetite Control and Energy Balance Group, School of Psychology, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Blundell', 'Affiliation': 'Human Appetite Research Unit, Appetite Control and Energy Balance Group, School of Psychology, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'Human Appetite Research Unit, Appetite Control and Energy Balance Group, School of Psychology, University of Leeds, Leeds LS2 9JT, UK.'}]",The British journal of nutrition,['10.1017/S000711451900179X']
1996,32179871,Gut microbiota in neonates with congenital gastrointestinal surgical conditions: a prospective study.,"BACKGROUND


There is limited information on gut microbiota of neonates with congenital gastrointestinal surgical conditions (CGISCs) available.
METHODS


This study compared stool microbiota and short-chain fatty acids (SCFAs) of 37 term infants with CGISCs with 36 term healthy infants (HIs). Two stool samples were collected from each infant: as soon as possible after birth (week 1) and 10-14 days of life (week 2).
RESULTS


Bacterial richness and alpha diversity were comparable between CGISCs and HIs at week 1 and week 2 (all p > 0.05). Beta diversity analysis revealed that at week 1, CGISCs had similar community structures to HIs (p = 0.415). However, by week 2, community structures of CGISCs were significantly different from HIs (p = 0.003). At week 1, there were no significant differences in the relative abundances of genera Bifidobacterium and Bacteroides between CGISCs and HIs. At week 2, the relative abundance of Bifidobacterium was significantly lower in CGISCs (mean percentage 7.21 ± 13.49 vs. 28.96 ± 19.6; p = 0.002). Bacteroides were also less abundant in the CGISC group (mean percentage 0.12 ± 0.49 vs. 6.59 ± 8.62; p = 0.039). Relative abundance of genera Pseudomonas and Escherichia-Shigella were higher in CGISCs. At week 2, stool concentrations of all SCFAs were lower in CGISCs (all p < 0.001).
CONCLUSIONS


During hospitalization, neonates with CGISCs develop gut dysbiosis and deficiency of SCFAs.
IMPACT


During hospitalisation, neonates with congenital gastrointestinal surgical conditions develop gut dysbiosis with deficiency of Bifidobacteria and Bacteroides and increased abundance of Escherichia-Shigella and Pseudomonas. They also have low levels of short chain fatty acids in their stools compared to healthy infants.This is the first study evaluating the gut microbiota using 16S ribosomal RNA sequencing methods and stool short chain fatty acids in neonates with congenital gastrointestinal surgical conditions and comparing them to healthy infants.The findings of this study will pave the way for randomised trials of bifidobacterial supplementation in neonates with congenital gastrointestinal surgical conditions.",2020,"At week 1, there were no significant differences in the relative abundances of genera Bifidobacterium and Bacteroides between CGISCs and HIs.","['neonates with congenital gastrointestinal surgical conditions and comparing them to healthy infants', 'neonates with congenital gastrointestinal surgical conditions (CGISCs) available', '37 term infants with CGISCs with 36 term healthy infants (HIs', 'neonates with congenital gastrointestinal surgical conditions']","['bifidobacterial supplementation', '16S ribosomal RNA sequencing methods and stool short chain fatty acids', 'stool microbiota and short-chain fatty acids (SCFAs']","['relative abundances of genera Bifidobacterium and Bacteroides', 'Relative abundance of genera Pseudomonas and Escherichia-Shigella', 'community structures of CGISCs', 'stool concentrations of all SCFAs', 'Bacteroides', 'Bacterial richness and alpha diversity', 'relative abundance of Bifidobacterium', 'Gut microbiota']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}]","[{'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Fatty Acids, Short-Chain'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]","[{'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0004661', 'cui_str': 'Bacteroides'}, {'cui': 'C0033808', 'cui_str': 'Flavimonas'}, {'cui': 'C0014833', 'cui_str': 'Escherichia'}, {'cui': 'C0036953', 'cui_str': 'Shigella'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}]",37.0,0.0788522,"At week 1, there were no significant differences in the relative abundances of genera Bifidobacterium and Bacteroides between CGISCs and HIs.","[{'ForeName': 'Shripada C', 'Initials': 'SC', 'LastName': 'Rao', 'Affiliation': ""Neonatal Intensive Care Unit, Perth Children's Hospital and King Edward Memorial Hospital for Women, Perth, WA, Australia. shripada.rao@health.wa.gov.au.""}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Esvaran', 'Affiliation': 'Centre for Marine Science and Innovation at the University of New South Wales (UNSW), Sydney, NSW, Australia.'}, {'ForeName': 'Sanjay K', 'Initials': 'SK', 'LastName': 'Patole', 'Affiliation': ""Neonatal Intensive Care Unit, Perth Children's Hospital and King Edward Memorial Hospital for Women, Perth, WA, Australia.""}, {'ForeName': 'Karen N', 'Initials': 'KN', 'LastName': 'Simmer', 'Affiliation': ""Neonatal Intensive Care Unit, Perth Children's Hospital and King Edward Memorial Hospital for Women, Perth, WA, Australia.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Gollow', 'Affiliation': ""Department of Paediatric Surgery, Perth Children's Hospital, Perth, WA, Australia.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Keil', 'Affiliation': 'PathWest Laboratory Medicine, Perth, WA, Australia.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Wemheuer', 'Affiliation': 'Centre for Marine Science and Innovation at the University of New South Wales (UNSW), Sydney, NSW, Australia.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'School of Chemical and Biomedical Engineering, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Conway', 'Affiliation': 'Centre for Marine Science and Innovation at the University of New South Wales (UNSW), Sydney, NSW, Australia.'}]",Pediatric research,['10.1038/s41390-020-0824-7']
1997,31667584,Feasibility of ultrasound-guided lumbar epidural access using paramedian transverse scanning with the needle in-plane: a comparison with paramedian sagittal scanning.,"BACKGROUND AND OBJECTIVES


The present study was designed to compare the feasibility of ultrasound (US)-guided lumbar epidural access using paramedian sagittal scanning (PMSS) and paramedian transverse scanning (PMTS) approaches.
METHODS


Fifty patients undergoing surgery of the lower extremities were randomly allocated into 2 groups. The patients in PMSS group received PMSS-guided in-plane epidural access, whereas patients in PMTS group received PMTS-guided in-plane epidural access. The US visibility of neuraxial structures and of Tuohy needle during US scout scan, procedure duration, the number of attempts to access epidural space, Tuohy needle puncture depth in the epidural space, and extent of sensory block after spinal block between two groups were compared.
RESULTS


The US visibility of Tuohy needle and neuraxial structures was comparable between two groups. There was an overall decrease in procedure duration in the PMTS group relative to the PMSS group (360 ± 42 vs. 490 ± 38 s). The number of attempts needed to access the epidural space in PMSS group was significantly higher than in PMTS group. Distances between the epidural space and the puncture site in PMSS group and PMTS group showed a significant difference (7.13 ± 0.67 vs. 5.24 ± 0.21 cm). No significant differences in the extent of sensory block after spinal block were observed.
CONCLUSIONS


We found that PMTS approach was superior as a means of achieving epidural access relative to the PMSS approach, since PMTS approach can be conducted more quickly given shorter path of the needle and less times needed for epidural access during this procedure.
CLINICAL TRIAL REGISTRATION


Chinese Clinical Trial Registry, clinical trial number ChiCTR1800015815, date of registration April 24, 2018.",2020,The US visibility of Tuohy needle and neuraxial structures was comparable between two groups.,['Fifty patients undergoing surgery of the lower extremities'],"['paramedian sagittal scanning', 'PMSS', 'paramedian transverse scanning', 'ultrasound (US)-guided lumbar epidural access using paramedian sagittal scanning (PMSS) and paramedian transverse scanning (PMTS', 'PMTS-guided in-plane epidural access', 'ultrasound-guided lumbar epidural access', 'PMSS-guided in-plane epidural access']","['sensory block after spinal block', 'number of attempts needed to access the epidural space', 'procedure duration', 'US visibility of Tuohy needle and neuraxial structures']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]","[{'cui': 'C0441993', 'cui_str': 'Paramedian approach (qualifier value)'}, {'cui': 'C0205129', 'cui_str': 'Sagittal (qualifier value)'}, {'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0228134', 'cui_str': 'Epidural Space'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0184186', 'cui_str': 'Tuohy epidural needle'}]",50.0,0.0479317,The US visibility of Tuohy needle and neuraxial structures was comparable between two groups.,"[{'ForeName': 'Huili', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, No. 8, Gongtinan Road, Chaoyang District, Beijing, 100020, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': 'Department of Pharmaceutical Science, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': 'Department of Anesthesiology, Miyun Hospital, Beijing, China.'}, {'ForeName': 'Danxu', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, No. 8, Gongtinan Road, Chaoyang District, Beijing, 100020, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, No. 8, Gongtinan Road, Chaoyang District, Beijing, 100020, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, No. 8, Gongtinan Road, Chaoyang District, Beijing, 100020, China. wangyun129@ccmu.edu.cn.'}]",Journal of anesthesia,['10.1007/s00540-019-02704-7']
1998,31611038,"Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial.","BACKGROUND


Non-alcoholic fatty liver disease (NAFLD) is a substantial cause of comorbidity in people with HIV and there are no proven pharmacological treatments for the disease in this population. We assessed the effects of tesamorelin on liver fat and histology in people with HIV and NAFLD.
METHODS


This randomised, double-blind, multicentre study with identical placebo as a comparator was done in a hospital and a medical research centre in the USA. People with HIV infection and a hepatic fat fraction (HFF) of 5% or more by proton magnetic resonance spectroscopy were eligible. Participants were randomly assigned (1:1) to receive either tesamorelin 2 mg once daily or placebo once daily for 12 months, followed by a 6-month open-label phase during which all participants received tesamorelin 2 mg daily. The randomisation list was prepared by the study statistician using a permuted block algorithm within each stratum with randomly varying block sizes. The primary endpoint was change in HFF between baseline and 12 months. The primary safety endpoint was glucose. Analysis was by intention to treat using all available data. This trial is registered with ClinicalTrials.gov, number NCT02196831.
FINDINGS


61 patients were enrolled between Aug 20, 2015, and Jan 16, 2019, of whom 30 received tesamorelin and 30 received placebo. Patients receiving tesamorelin had a greater reduction of HFF than did patients receiving placebo, with an absolute effect size of -4·1% (95% CI -7·6 to -0·7, p=0·018), corresponding to a -37% (95% CI -67 to -7, p=0·016) relative reduction from baseline. After 12 months, 35% of individuals receiving tesamorelin and 4% receiving placebo had a HFF of less than 5% (p=0·0069). Changes in fasting glucose and glycated haemoglobin were not different between groups at 12 months. Individuals in the tesamorelin group experienced more localised injection site complaints than those in the placebo group, though none were judged to be serious.
INTERPRETATION


Tesamorelin might be beneficial in people with HIV and NAFLD. Further studies are needed to determine the long-term effects of tesamorelin on liver histology.
FUNDING


National Institutes of Health and National Institute of Allergy and Infectious Diseases.",2019,"Individuals in the tesamorelin group experienced more localised injection site complaints than those in the placebo group, though none were judged to be serious.
","['people with HIV and NAFLD', '61 patients were enrolled between Aug 20, 2015, and Jan 16, 2019, of whom 30 received tesamorelin and 30 received', 'non-alcoholic fatty liver disease in HIV', 'People with HIV infection and a hepatic fat fraction (HFF) of 5% or more by proton magnetic resonance spectroscopy were eligible']","['tesamorelin', 'tesamorelin 2 mg daily', 'tesamorelin 2 mg once daily or placebo', 'Tesamorelin', 'placebo']","['liver fat and histology', 'localised injection site complaints', 'fasting glucose and glycated haemoglobin', 'reduction of HFF', 'change in HFF']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1876200', 'cui_str': 'tesamorelin'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}]","[{'cui': 'C1876200', 'cui_str': 'tesamorelin'}, {'cui': 'C4057885', 'cui_str': 'tesamorelin 2 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0221208', 'cui_str': 'Injection site (morphologic abnormality)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",61.0,0.787467,"Individuals in the tesamorelin group experienced more localised injection site complaints than those in the placebo group, though none were judged to be serious.
","[{'ForeName': 'Takara L', 'Initials': 'TL', 'LastName': 'Stanley', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Lindsay T', 'Initials': 'LT', 'LastName': 'Fourman', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Meghan N', 'Initials': 'MN', 'LastName': 'Feldpausch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Purdy', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health and University of Maryland, Bethesda, MD, USA.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Zheng', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Chelsea S', 'Initials': 'CS', 'LastName': 'Pan', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Aepfelbacher', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health and University of Maryland, Bethesda, MD, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Buckless', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Tsao', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Anela', 'Initials': 'A', 'LastName': 'Kellogg', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health and University of Maryland, Bethesda, MD, USA; Frederick National Laboratory for Cancer Research, Frederick, MA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Branch', 'Affiliation': 'Massachusetts General Hospital Clinical Research Center, Boston, MA, USA.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Massachusetts General Hospital Biostatistics Center, Boston, MA, USA.'}, {'ForeName': 'Chia-Ying', 'Initials': 'CY', 'LastName': 'Liu', 'Affiliation': 'Radiology and Imaging Sciences, Clinical Center, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Corey', 'Affiliation': 'Liver Center, Gastroenterology Division, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Raymond T', 'Initials': 'RT', 'LastName': 'Chung', 'Affiliation': 'Liver Center, Gastroenterology Division, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Torriani', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kleiner', 'Affiliation': 'Laboratory of Pathology, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Colleen M', 'Initials': 'CM', 'LastName': 'Hadigan', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health and University of Maryland, Bethesda, MD, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. Electronic address: sgrinspoon@partners.org.'}]",The lancet. HIV,['10.1016/S2352-3018(19)30338-8']
1999,31738283,"Effect of Dextrose Prolotherapy on Pain Intensity, Disability, and Plantar Fascia Thickness in Unilateral Plantar Fasciitis: A Randomized, Controlled, Double-Blind Study.","OBJECTIVE


The aim of the study was to evaluate the efficacy of dextrose prolotherapy in the treatment of chronic resistant plantar fasciitis through comparison with a control group.
DESIGN


In this double-blind, randomized, controlled study, the patients were divided into two groups. The prolotherapy group (n = 30) was administered 5 ml of 30% dextrose, 4 ml of saline, and 1 ml of 2% lidocaine mixture (15% dextrose solution) and the control group was given 9 ml of saline and 1 ml of 2% lidocaine mixture twice at a 3-wk interval. During the 15-wk follow-up period, pain intensity was measured using the visual analog scale during activity and at rest. The foot function index was used to measure pain and disability. The plantar fascia thickness was measured by ultrasonography. The measurements were undertaken before treatment and at posttreatment weeks 7 and 15.
RESULTS


Improvements in visual analog scale during activity, at rest, foot function index (all subgroups), and plantar fascia thickness measured at the 7th and 15th weeks were significantly higher in the prolotherapy group compared with the control group (P < 0.001).
CONCLUSIONS


Dextrose prolotherapy has efficacy up to 15 wks and can be used as an alternative method in the treatment of chronic resistant plantar fasciitis.",2020,"RESULTS


Improvements in VAS-A, VAS-R, FFI (all subgroups), and plantar fascia thickness measured at the 7th and 15th weeks were significantly higher in the prolotherapy group compared to the control group (p>0.001).
","['chronic resistant plantar fasciitis (PF', 'Unilateral Plantar Fasciitis']","['Dextrose prolotherapy', 'Dextrose Prolotherapy', '5 cc 30% dextrose, 4 cc saline, 1cc 2% lidocaine mixture (15% dextrose solution) and the control group was given 9 cc saline and 1 cc 2% lidocaine mixture', 'prolotherapy', 'dextrose prolotherapy']","['visual analog scale during activity (VAS-A) and at rest (VAS-R', 'pain and disability', 'VAS-A, VAS-R, FFI (all subgroups), and plantar fascia thickness', 'plantar fascia thickness', 'pain intensity', 'foot function index (FFI', 'Pain Intensity, Disability and Plantar Fascia Thickness']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0149756', 'cui_str': ""Policeman's Heel""}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0500223', 'cui_str': 'Proliferation Therapy'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0078085', 'cui_str': 'VAS-A'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4706287', 'cui_str': 'Foot Function Index (assessment scale)'}]",,0.0651174,"RESULTS


Improvements in VAS-A, VAS-R, FFI (all subgroups), and plantar fascia thickness measured at the 7th and 15th weeks were significantly higher in the prolotherapy group compared to the control group (p>0.001).
","[{'ForeName': 'Basak', 'Initials': 'B', 'LastName': 'Mansiz-Kaplan', 'Affiliation': 'From the Department of Physical Medicine and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Baris', 'Initials': 'B', 'LastName': 'Nacir', 'Affiliation': ''}, {'ForeName': 'Secil', 'Initials': 'S', 'LastName': 'Pervane-Vural', 'Affiliation': ''}, {'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Duyur-Cakit', 'Affiliation': ''}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Genc', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001330']
2000,31326730,Low-molecular-weight heparin adherence and effects on survival within a randomised phase III lung cancer trial (RASTEN).,"BACKGROUND


Coagulation activation is a hallmark of cancer, and anticoagulants have shown tumour-inhibiting properties. However, recent trials have failed to demonstrate improved survival with low-molecular-weight heparin (LMWH) in cancer populations. This has raised the question of suboptimal adherence as a possible explanation for the lack of benefit. Still, there is no standardised method to directly monitor LMWH in patient plasma. Here, we directly determine LMWH levels in patients using the Heparin Red assay to objectively assess adherence and how this associates with the patient outcome in the RASTEN trial.
METHODS


RASTEN is a multicentre, randomised phase III trial investigating if the addition of LMWH to standard therapy can improve survival in small-cell lung cancer. LMWH was measured in plasma (N = 258) by the Heparin Red assay and compared with the anti-factor Xa (anti-FXa) activity assay.
RESULTS


Both methods could differentiate patients in the LMWH arm from the control arm and patients receiving therapeutic LMWH owing to thrombosis. Receiver Operating Characteristic (ROC) analysis yielded adherence rates of 85% for anti-FXa and 68% for Heparin Red. No survival benefits were found in the adherent subgroup compared with the control arm (hazard ratio [HR]: 1.26; 95% confidence interval [CI]: 0.95-1.67; P = 0.105 and HR: 1.19; 95% CI: 0.89-1.60; P = 0.248 for anti-FXa and Heparin Red, respectively). Heparin Red could define patients with high probability of adherence to LMWH treatment, which warrants prospective studies for further validation. Our finding that the LMWH-adherent subpopulation did not show improved survival excludes that the negative outcome of RASTEN was due to poor adherence.",2019,Receiver Operating Characteristic (ROC) analysis yielded adherence rates of 85% for anti-FXa and 68% for Heparin Red.,['small-cell lung cancer'],"['LMWH', 'Heparin Red', 'Heparin Red assay']","['survival excludes', 'survival', 'LMWH', 'Receiver Operating Characteristic (ROC) analysis yielded adherence rates', 'survival benefits']","[{'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}]","[{'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",,0.171485,Receiver Operating Characteristic (ROC) analysis yielded adherence rates of 85% for anti-FXa and 68% for Heparin Red.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gezelius', 'Affiliation': 'Department of Clinical Sciences, Lund, Division of Oncology, Lund University, Barngatan 4, SE-221 85, Lund Sweden; Department of Respiratory Medicine, Skåne University Hospital, Entrégatan 7, SE-221 85, Lund, Sweden. Electronic address: Emelie.gezelius@med.lu.se.'}, {'ForeName': 'P O', 'Initials': 'PO', 'LastName': 'Bendahl', 'Affiliation': 'Department of Clinical Sciences, Lund, Division of Oncology, Lund University, Barngatan 4, SE-221 85, Lund Sweden.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Gonçalves de Oliveira', 'Affiliation': 'Department of Clinical Sciences, Lund, Division of Oncology, Lund University, Barngatan 4, SE-221 85, Lund Sweden.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ek', 'Affiliation': 'Department of Respiratory Medicine, Skåne University Hospital, Entrégatan 7, SE-221 85, Lund, Sweden.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bergman', 'Affiliation': 'Department of Respiratory Medicine, Sahlgrenska University Hospital, SE-413 45, Gothenburg, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sundberg', 'Affiliation': 'Department of Hematology, Radiophysics and Oncology, Skåne University Hospital, Lasarettsgatan 23A, SE-221 85, Lund, Sweden.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Strandberg', 'Affiliation': 'Department of Clinical Chemistry, Institution of Laboratory Medicine, Lund University, Inga Marie Nilssons Gata 53, SE-214 28, Malmö, Sweden.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Krämer', 'Affiliation': 'Inorganic Chemistry Institute, Heidelberg University, Im Neuenheimer Feld 270, 60129, Heidelberg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Belting', 'Affiliation': 'Department of Clinical Sciences, Lund, Division of Oncology, Lund University, Barngatan 4, SE-221 85, Lund Sweden; Department of Hematology, Radiophysics and Oncology, Skåne University Hospital, Lasarettsgatan 23A, SE-221 85, Lund, Sweden; Department of Immunology, Pathology, and Genetics, Uppsala University, Rudbecklaboratoriet, SE-751 85, Uppsala, Sweden.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.06.015']
2001,32062324,The detection of knee joint sounds at defined loads by means of vibroarthrography.,"BACKGROUND


Crepitus of the knee may mirror structural and functional changes in the joint during motion. Although the magnitude of these sounds increases with greater cartilage damage, it is unclear whether knee joint sounds also reflect joint loading.
METHODS


Twelve healthy volunteers (mean 26 (SD 3.6) years, 7 females) participated in the randomized-balanced crossover study. Knee joint sounds were recorded (linear sampling, 5512 Hz) by means of two microphones, one placed on the medial tibial plateau and one on the patella. Two activities of daily living (standing up from/sitting down on a bench; descending stairs) and three open kinetic chain knee extension-flexion cycles (passive movement, 10% and 40% loading of the individual one repetition maximum) were performed. Each participant carried out three sets of five repetitions and three sets of 15 steps downwards (stairs), respectively. For data analysis, the mean sound amplitude and the median power frequency for each loading condition were determined. Friedman test and Bonferroni-Holm adjusted post-hoc test were performed to detect differences between conditions.
FINDINGS


We obtained significant differences between joint sound amplitudes for all movements, both measured at the medial tibial plateau (Chi 2  = 20.7, p < 0.001) and at the patella (Chi 2  = 27.6, p < 0.001). We showed a significant difference in the median power frequency of the patella between all movements (Chi 2  = 17.8, p < 0.5).
INTERPRETATION


Overall, the larger the supposed knee joint loading was, the louder was the recorded knee crepitus. Consequently, vibroarthrographically assessed knee joint sounds can differ across knee joint loading conditions.",2020,"We obtained significant differences between joint sound amplitudes for all movements, both measured at the medial tibial plateau","['mean 26 (SD 3.6) years, 7 females', 'Twelve healthy volunteers']","['daily living (standing up from/sitting down on a bench; descending stairs) and three open kinetic chain knee extension-flexion cycles (passive movement, 10% and 40% loading of the individual one repetition maximum']","['median power frequency of the patella', 'Knee joint sounds', 'medial tibial plateau']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0444796', 'cui_str': 'Standing up (observable entity)'}, {'cui': 'C0560831', 'cui_str': 'Does sit down (finding)'}, {'cui': 'C0205386', 'cui_str': 'Descending (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0079991', 'cui_str': 'Passive Range of Motion'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0030647', 'cui_str': 'Kneecap'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0584640', 'cui_str': 'Tibial plateau structure (body structure)'}]",12.0,0.0353578,"We obtained significant differences between joint sound amplitudes for all movements, both measured at the medial tibial plateau","[{'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Kalo', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt am Main, Germany. Electronic address: kalo@rz.uni-frankfurt.de.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Niederer', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt am Main, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Sus', 'Affiliation': 'Faculty of Health Sciences, University of Applied Sciences, Giessen, Germany.'}, {'ForeName': 'Keywan', 'Initials': 'K', 'LastName': 'Sohrabi', 'Affiliation': 'Faculty of Health Sciences, University of Applied Sciences, Giessen, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Banzer', 'Affiliation': 'Department of Preventive and Sports Medicine, Institute for Occupational, Social and Environmental Medicine, Goethe University Frankfurt am Main, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Groß', 'Affiliation': 'Faculty of Health Sciences, University of Applied Sciences, Giessen, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt am Main, Germany.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.01.021']
2002,32156749,A Randomized Phase II Preoperative Study of Autophagy Inhibition with High-Dose Hydroxychloroquine and Gemcitabine/Nab-Paclitaxel in Pancreatic Cancer Patients.,"PURPOSE


We hypothesized that autophagy inhibition would increase response to chemotherapy in the preoperative setting for patients with pancreatic adenocarcinoma. We performed a randomized controlled trial to assess the autophagy inhibitor hydroxychloroquine in combination with gemcitabine and nab-paclitaxel.
PATIENTS AND METHODS


Participants with potentially resectable tumors were randomized to two cycles of nab-paclitaxel and gemcitabine (PG) alone or with hydroxychloroquine (PGH), followed by resection. The primary endpoint was histopathologic response in the resected specimen. Secondary clinical endpoints included serum CA 19-9 biomarker response and margin negative R0 resection. Exploratory endpoints included markers of autophagy, immune infiltrate, and serum cytokines.
RESULTS


Thirty-four patients in the PGH arm and 30 in the PG arm were evaluable for the primary endpoint. The PGH arm demonstrated statistically improved Evans grade histopathologic responses ( P  = 0.00016), compared with control. In patients with elevated CA 19-9, a return to normal was associated with improved overall and recurrence-free survival ( P  < 0.0001). There were no differences in serious adverse events between arms and chemotherapy dose number was equivalent. The PGH arm had greater evidence of autophagy inhibition in their resected specimens (increased SQSTM1,  P  = 0.027, as well as increased immune cell tumor infiltration,  P  = 0.033). Overall survival ( P  = 0.59) and relapse-free survival ( P  = 0.55) did not differ between the two arms.
CONCLUSIONS


The addition of hydroxychloroquine to preoperative gemcitabine and nab-paclitaxel chemotherapy in patients with resectable pancreatic adenocarcinoma resulted in greater pathologic tumor response, improved serum biomarker response, and evidence of autophagy inhibition and immune activity.",2020,"In patients with elevated CA 19-9, a return to normal was associated with improved overall and recurrence-free survival (P < 0.0001).","['patients with resectable pancreatic adenocarcinoma', 'patients with pancreatic adenocarcinoma', 'Pancreatic Cancer Patients', 'Participants with potentially resectable tumors']","['nab-paclitaxel and gemcitabine (PG) alone or with hydroxychloroquine (PGH', 'hydroxychloroquine to preoperative gemcitabine and nab-paclitaxel chemotherapy', 'gemcitabine and nab-paclitaxel', 'Hydroxychloroquine and Gemcitabine/Nab-Paclitaxel', 'autophagy inhibitor hydroxychloroquine', 'Autophagy Inhibition']","['pathological tumor response, improved serum biomarker response, and evidence of autophagy inhibition and immune activity', 'overall and recurrence-free survival', 'serious adverse events', 'markers of autophagy, immune infiltrate, and serum cytokines', 'CA 19-9 serum biomarker response and margin negative R0 resection', 'RFS', 'autophagy inhibition', 'histopathologic response', 'Evans grade histopathologic responses']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0072288', 'cui_str': 'Prostaglandin H2'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0004391', 'cui_str': 'Cellular Autophagies'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0004391', 'cui_str': 'Cellular Autophagies'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332448', 'cui_str': 'Tissue infiltration'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0201551', 'cui_str': 'CA 199 measurement'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",34.0,0.0657666,"In patients with elevated CA 19-9, a return to normal was associated with improved overall and recurrence-free survival (P < 0.0001).","[{'ForeName': 'Herbert J', 'Initials': 'HJ', 'LastName': 'Zeh', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Bahary', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania. baharyn@upmc.edu.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Boone', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Aatur D', 'Initials': 'AD', 'LastName': 'Singhi', 'Affiliation': 'Department of Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jennifer Lee', 'Initials': 'JL', 'LastName': 'Miller-Ocuin', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Normolle', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Amer H', 'Initials': 'AH', 'LastName': 'Zureikat', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Melissa E', 'Initials': 'ME', 'LastName': 'Hogg', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Bartlett', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Kenneth K', 'Initials': 'KK', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Tsung', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'J Wallis', 'Initials': 'JW', 'LastName': 'Marsh', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Pranav', 'Initials': 'P', 'LastName': 'Murthy', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Daolin', 'Initials': 'D', 'LastName': 'Tang', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Seiser', 'Affiliation': ""HPB and Transplant Institute at St. Vincent's Medical Center, Los Angeles, California.""}, {'ForeName': 'Ravi K', 'Initials': 'RK', 'LastName': 'Amaravadi', 'Affiliation': 'Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Espina', 'Affiliation': 'Center for Applied Proteomics and Molecular Medicine, George Mason University, Manassas, Virginia.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Liotta', 'Affiliation': 'Center for Applied Proteomics and Molecular Medicine, George Mason University, Manassas, Virginia.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Lotze', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-4042']
2003,32036693,"Secretin effects on gastric functions, hormones and symptoms in functional dyspepsia and health: randomized crossover trial.","Abnormal gastric accommodation (GA) and gastric emptying contribute to pathophysiology in functional dyspepsia (FD). Secretin is a key regulator of GA in animal studies. Our aim was to study the effects of secretin on gastric motility, satiation, postprandial symptoms, and key hormones. We performed two double-blind, randomized, saline-controlled crossover trials in 10 healthy volunteers and 10 patients with FD by Rome IV criteria. We used measured GA (by validated SPECT method) after a  111 In radiolabeled Ensure 300-mL meal and quantified gastric emptying for 30 min by scintigraphy. Satiation was measured by volume to fullness (VTF) and maximum tolerated volume (MTV) on an Ensure nutrient drink test and postprandial symptoms 30 min post-MTV. Fasting and postprandial GLP-1, GIP, and HPP were measured. The ages and sex distribution of healthy controls and patients with FD were similar. Compared with placebo, secretin delayed gastric emptying at 30 min in both health [-11% (-16, -4),  P  = 0.004]; and FD [-8% (-9, 0),  P  = 0.03]. Satiation (VTF and MTV), GA, and plasma levels of GLP-1, GIP, and HPP did not differ between treatment arms in health or FD. On ANCOVA analysis (adjusting for age and sex), secretin did not consistently increase postprandial symptoms in health or FD. Secretin delayed gastric emptying in both health and FD without significantly altering GA, VTF, or MTV or selected hormones. Thus, secretin receptor activation may provide a novel therapeutic mechanism for patients with FD and rapid gastric emptying. NEW & NOTEWORTHY  The naturally occurring hormone secretin retards gastric emptying of solids without deleteriously affecting gastric accommodation, satiation, other upper gastrointestinal hormones, or postprandial symptoms. Given these findings, a subset of patients with rapid gastric emptying (e.g., the estimated 20% of patients with functional dyspepsia) could be candidates for treatments that stimulate a secretin receptor such as sacubitril, which inhibits neprilysin, an enzyme that degrades secretin.",2020,"Compared to placebo, secretin delayed gastric emptying at 30 minutes in both health [-11% (-16, -4); P=0.004] and FD [-8% (-9, 0); P=0.03].","['patients with FD and rapid gastric emptying', '10 healthy volunteers and 10 patients with FD by Rome IV criteria', 'DYSPEPSIA AND HEALTH', 'functional dyspepsia (FD']","['placebo', 'Secretin', 'secretin']","['postprandial symptoms in health or FD', 'Satiation (VTF and MTV), GA as well as plasma levels of GLP1, GIP and HPP', 'Abnormal gastric accommodation (GA) and gastric emptying', 'Fasting and postprandial GLP-1, GIP and HPP', 'secretin delayed gastric emptying', 'Secretin delayed gastric emptying', 'volume to fullness (VTF) and maximum tolerated volume (MTV', 'gastric motility, satiation, postprandial symptoms and key hormones']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0232584', 'cui_str': 'Rapid gastric emptying (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036534', 'cui_str': 'Secretin'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0068293', 'cui_str': 'N-succinimidyl-3-(4-hydroxyphenyl)propionate'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0000936', 'cui_str': 'Ocular Distance Accommodation'}, {'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0036534', 'cui_str': 'Secretin'}, {'cui': 'C0740411', 'cui_str': 'Delayed gastric emptying (disorder)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0232572', 'cui_str': 'Gastric motility, function (observable entity)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}]",10.0,0.0959755,"Compared to placebo, secretin delayed gastric emptying at 30 minutes in both health [-11% (-16, -4); P=0.004] and FD [-8% (-9, 0); P=0.03].","[{'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Brandler', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Laurence J', 'Initials': 'LJ', 'LastName': 'Miller', 'Affiliation': 'Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Xiao Jing', 'Initials': 'XJ', 'LastName': 'Wang', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Duane', 'Initials': 'D', 'LastName': 'Burton', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Busciglio', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Arndt', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Harmsen', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Camilleri', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}]",American journal of physiology. Gastrointestinal and liver physiology,['10.1152/ajpgi.00371.2019']
2004,31973744,"Improving risk perception and uptake of voluntary medical male circumcision with peer-education sessions and incentives, in Manicaland, East Zimbabwe: study protocol for a pilot randomised trial.","BACKGROUND


Voluntary medical male circumcision (VMMC) is a key component of combination HIV-prevention programmes. Several high-HIV-prevalence countries in sub-Saharan Africa, including Zimbabwe, are looking to scale up VMMC activities. There is limited evidence on how a combination of social learning from peer education by a role model with different behavioural incentives influences demand for VMMC in such settings.
METHODS/DESIGN


This matched-cluster randomised controlled trial with 1740 participants will compare two behavioural incentives against a control with no intervention. In the intervention clusters, participants will participate in an education session delivered by a circumcised young male (""role model"") on the risks of HIV infection and the benefits from medical male circumcision. All participants will receive contributions towards transport costs to access medical male circumcision at participating clinics. Via blocked randomisation, in the intervention clusters participants will be randomly assigned to receive one of two types of incentives - fixed cash payment or lottery payment - both conditional on undergoing surgical VMMC. In two sites, a community-led intervention will also be implemented to address social obstacles and to increase support from peers, families and social structures. Baseline measures of endpoints will be gathered in surveys. Follow-up assessment at 6 months will include self-reported uptake of VMMC triangulated with clinic data.
DISCUSSION


This is the first trial to pilot-test social learning to improve risk perception and self-efficacy and to address the fear of pain associated with VMMC and possible present-biased preferences with front-loaded compensations as well as fixed or lottery-based cash payments. This study will generate important knowledge to inform HIV-prevention policies about the effectiveness of behavioural interventions and incentives, which could be easily scaled-up.
TRIAL REGISTRATION


This trial has been registered on ClinicalTrials.gov (identifier: NCT03565588). Registered on 21 June 2018.",2020,This is the first trial to pilot-test social learning to improve risk perception and self-efficacy and to address the fear of pain associated with VMMC and possible present-biased preferences with front-loaded compensations as well as fixed or lottery-based cash payments.,"['All participants will receive contributions towards transport costs to access medical male circumcision at participating clinics', '1740 participants', 'Voluntary medical male circumcision (VMMC']","['education session delivered by a circumcised young male (""role model', 'incentives - fixed cash payment or lottery payment - both conditional on undergoing surgical VMMC', 'behavioural incentives against a control with no intervention']",['risk perception and self-efficacy'],"[{'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0008819', 'cui_str': 'Male Circumcision'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0920194', 'cui_str': 'Circumcised'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",1740.0,0.0637398,This is the first trial to pilot-test social learning to improve risk perception and self-efficacy and to address the fear of pain associated with VMMC and possible present-biased preferences with front-loaded compensations as well as fixed or lottery-based cash payments.,"[{'ForeName': 'Ranjeeta', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': 'Department of Health Policy, London School of Economics and Political Science, Cowdray House, London, WC2 2AE, UK. r.a.thomas@lse.ac.uk.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Skovdal', 'Affiliation': 'Section of Health Services Research, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5 opg, B, Postb 15, Building: 15.0.17, 1014, København K, Denmark.'}, {'ForeName': 'Matteo M', 'Initials': 'MM', 'LastName': 'Galizzi', 'Affiliation': 'Department of Psychological and Behavioural Science, London School of Economics and Political Science, London, WC2 2AE, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Schaefer', 'Affiliation': ""Department of Infectious Disease Epidemiology, Imperial College London, St Mary's Campus Norfolk Place, London, W2 1PG, UK.""}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Moorhouse', 'Affiliation': ""Department of Infectious Disease Epidemiology, Imperial College London, St Mary's Campus Norfolk Place, London, W2 1PG, UK.""}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Nyamukapa', 'Affiliation': ""Department of Infectious Disease Epidemiology, Imperial College London, St Mary's Campus Norfolk Place, London, W2 1PG, UK.""}, {'ForeName': 'Rufurwokuda', 'Initials': 'R', 'LastName': 'Maswera', 'Affiliation': 'Biomedical Research and Training Institute, 10 Seagrave, Avondale, Harare, Zimbabwe.'}, {'ForeName': 'Phyllis', 'Initials': 'P', 'LastName': 'Mandizvidza', 'Affiliation': 'Biomedical Research and Training Institute, 10 Seagrave, Avondale, Harare, Zimbabwe.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Hallett', 'Affiliation': ""Department of Infectious Disease Epidemiology, Imperial College London, St Mary's Campus Norfolk Place, London, W2 1PG, UK.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gregson', 'Affiliation': ""Department of Infectious Disease Epidemiology, Imperial College London, St Mary's Campus Norfolk Place, London, W2 1PG, UK.""}]",Trials,['10.1186/s13063-020-4048-2']
2005,31080095,Diagnostic accuracy of whole-body MRI versus standard imaging pathways for metastatic disease in newly diagnosed colorectal cancer: the prospective Streamline C trial.,"BACKGROUND


Whole-body MRI (WB-MRI) could be an alternative to multimodality staging of colorectal cancer, but its diagnostic accuracy, effect on staging times, number of tests needed, cost, and effect on treatment decisions are unknown. We aimed to prospectively compare the diagnostic accuracy and efficiency of WB-MRI-based staging pathways with standard pathways in colorectal cancer.
METHODS


The Streamline C trial was a prospective, multicentre trial done in 16 hospitals in England. Eligible patients were 18 years or older, with newly diagnosed colorectal cancer. Exclusion criteria were severe systemic disease, pregnancy, contraindications to MRI, or polyp cancer. Patients underwent WB-MRI, the result of which was withheld until standard staging investigations were complete and the first treatment decision made. The multidisciplinary team recorded its treatment decision based on standard investigations, then on the WB-MRI staging pathway (WB-MRI plus additional tests generated), and finally on all tests. The primary outcome was difference in per-patient sensitivity for metastases between standard and WB-MRI staging pathways against a consensus reference standard at 12 months, in the per-protocol population. Secondary outcomes were difference in per-patient specificity for metastatic disease detection between standard and WB-MRI staging pathways, differences in treatment decisions, staging efficiency (time taken, test number, and costs), and per-organ sensitivity and specificity for metastases and per-patient agreement for local T and N stage. This trial is registered with the International Standard Randomised Controlled Trial registry, number ISRCTN43958015, and is complete.
FINDINGS


Between March 26, 2013, and Aug 19, 2016, 1020 patients were screened for eligibility. 370 patients were recruited, 299 of whom completed the trial; 68 (23%) had metastasis at baseline. Pathway sensitivity was 67% (95% CI 56 to 78) for WB-MRI and 63% (51 to 74) for standard pathways, a difference in sensitivity of 4% (-5 to 13, p=0·51). No adverse events related to imaging were reported. Specificity did not differ between WB-MRI (95% [95% CI 92-97]) and standard pathways (93% [90-96], p=0·48). Agreement with the multidisciplinary team's final treatment decision was 96% for WB-MRI and 95% for the standard pathway. Time to complete staging was shorter for WB-MRI (median, 8 days [IQR 6-9]) than for the standard pathway (13 days [11-15]); a 5-day (3-7) difference. WB-MRI required fewer tests (median, one [95% CI 1 to 1]) than did standard pathways (two [2 to 2]), a difference of one (1 to 1). Mean per-patient staging costs were £216 (95% CI 211-221) for WB-MRI and £285 (260-310) for standard pathways.
INTERPRETATION


WB-MRI staging pathways have similar accuracy to standard pathways and reduce the number of tests needed, staging time, and cost.
FUNDING


UK National Institute for Health Research.",2019,"Time to complete staging was shorter for WB-MRI (median, 8 days [IQR 6-9]) than for the standard pathway (13 days [11-15]); a 5-day (3-7) difference.","['newly diagnosed colorectal cancer', '370 patients were recruited, 299 of whom completed the trial; 68 (23%) had metastasis at baseline', '16 hospitals in England', 'Eligible patients were 18 years or older, with newly diagnosed colorectal cancer', 'Between March 26, 2013, and Aug 19, 2016, 1020 patients were screened for eligibility']","['whole-body MRI versus standard imaging pathways', 'Whole-body MRI (WB-MRI']","['Specificity', 'Pathway sensitivity', 'per-patient sensitivity for metastases', 'Mean per-patient staging costs', 'severe systemic disease, pregnancy, contraindications to MRI, or polyp cancer', 'per-patient specificity for metastatic disease detection between standard and WB-MRI staging pathways, differences in treatment decisions, staging efficiency (time taken, test number, and costs), and per-organ sensitivity and specificity for metastases and per-patient agreement for local T and N stage']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C4517743', 'cui_str': 'Three hundred and seventy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C1142375', 'cui_str': 'Magnetic resonance imaging of whole body'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0442893', 'cui_str': 'Systemic illness (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0456532', 'cui_str': 'N category'}]",1020.0,0.205953,"Time to complete staging was shorter for WB-MRI (median, 8 days [IQR 6-9]) than for the standard pathway (13 days [11-15]); a 5-day (3-7) difference.","[{'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Taylor', 'Affiliation': 'Centre for Medical Imaging, University College London, London, UK. Electronic address: stuart.taylor@ucl.ac.uk.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Mallett', 'Affiliation': 'Institute of Applied Health Research, NIHR Birmingham Biomedical Research Centre, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, UK.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Beare', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, University College London, London, UK.'}, {'ForeName': 'Gauraang', 'Initials': 'G', 'LastName': 'Bhatnagar', 'Affiliation': 'Frimley Park Hospital, Frimley, UK.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Blunt', 'Affiliation': 'Imaging Department, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Boavida', 'Affiliation': 'Department of Radiology, Homerton Hospital, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'UCL Cancer Institute, London, UK.'}, {'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Clarke', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Duggan', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, University College London, London, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Ellis', 'Affiliation': 'Department of Radiology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Glynne-Jones', 'Affiliation': 'Mount Vernon Centre for Cancer Treatment, Mount Vernon Hospital, Northwood, UK.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Goh', 'Affiliation': ""Department of Cancer Imaging, School of Biomedical Engineering and Imaging Sciences, King's College London, King's Health Partners, London, UK.""}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Groves', 'Affiliation': 'Institute of Nuclear Medicine, University College London, London, UK.'}, {'ForeName': 'Ayshea', 'Initials': 'A', 'LastName': 'Hameeduddin', 'Affiliation': 'Department of Radiology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Sam M', 'Initials': 'SM', 'LastName': 'Janes', 'Affiliation': 'Lungs for Living Research Centre, UCL Respiratory, University College London, London, UK; Department of Thoracic Medicine, University College London Hospitals, UK.'}, {'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Johnston', 'Affiliation': 'Centre for Medical Imaging, University College London, London, UK.'}, {'ForeName': 'Dow-Mu', 'Initials': 'DM', 'LastName': 'Koh', 'Affiliation': 'Department of Radiology, Royal Marsden Hospital, Sutton, Surrey, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Miles', 'Affiliation': 'Department of Psychological Sciences, Birkbeck University of London, London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': 'Department of Applied Health Research, University College London, London, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Morton', 'Affiliation': 'Centre for Medical Imaging, University College London, London, UK.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Navani', 'Affiliation': 'Lungs for Living Research Centre, UCL Respiratory, University College London, London, UK; Department of Thoracic Medicine, University College London Hospitals, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': ""O'Donohue"", 'Affiliation': 'Department of Gastroenterology, Lewisham Hospital, London, UK.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Oliver', 'Affiliation': 'Centre for Medical Imaging, University College London, London, UK.'}, {'ForeName': 'Anwar R', 'Initials': 'AR', 'LastName': 'Padhani', 'Affiliation': 'Paul Strickland Scanner Centre, Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Pardoe', 'Affiliation': 'Department of Surgery, Homerton Hospital, London, UK.'}, {'ForeName': 'Uday', 'Initials': 'U', 'LastName': 'Patel', 'Affiliation': ""Intestinal Imaging Centre, St Mark's Hospital, LNWUH NHS Trust, Harrow, UK.""}, {'ForeName': 'Shonit', 'Initials': 'S', 'LastName': 'Punwani', 'Affiliation': 'Centre for Medical Imaging, University College London, London, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Quinn', 'Affiliation': 'Institute of Applied Health Research, NIHR Birmingham Biomedical Research Centre, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, UK.'}, {'ForeName': 'Hameed', 'Initials': 'H', 'LastName': 'Rafiee', 'Affiliation': 'Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, UK.'}, {'ForeName': 'Krystyna', 'Initials': 'K', 'LastName': 'Reczko', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, University College London, London, UK.'}, {'ForeName': 'Andrea G', 'Initials': 'AG', 'LastName': 'Rockall', 'Affiliation': 'Department of Radiology, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, UK; Department of Cancer and Surgery, Imperial College London, London, UK.'}, {'ForeName': 'Khawaja', 'Initials': 'K', 'LastName': 'Shahabuddin', 'Affiliation': 'Department of Radiology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Harbir S', 'Initials': 'HS', 'LastName': 'Sidhu', 'Affiliation': 'Centre for Medical Imaging, University College London, London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Teague', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, University College London, London, UK.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Thaha', 'Affiliation': 'Blizard Institute, National Bowel Research Centre, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK; Department of Surgery, Barts Health NHS Trust, The Royal London Hospital, London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Train', 'Affiliation': 'Department of Radiology, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'van Ree', 'Affiliation': 'Imaging Department, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Sanjaya', 'Initials': 'S', 'LastName': 'Wijeyekoon', 'Affiliation': 'Department of Surgery, Homerton Hospital, London, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Halligan', 'Affiliation': 'Centre for Medical Imaging, University College London, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30056-1']
2006,31147363,Effects of yoga on well-being and healthy ageing: study protocol for a randomised controlled trial (FitForAge).,"INTRODUCTION


Due to ageing populations worldwide, the burden of disability is increasing. It is therefore important to develop interventions that improve healthy ageing, reduce disability onset and enhance life quality. Physical activity can promote healthy ageing and help maintain independence, yet many older adults are inactive. Yoga is a form of physical activity that aims to improve health and may be particularly suitable for older adults. Research indicates positive effects of yoga on several health-related outcomes; however, empirical studies examining the benefits of yoga on well-being among the elderly remain scarce. This study protocol reports the methodology for a 12-week yoga programme aimed to improve health and well-being among physically inactive older adults.
METHODS AND ANALYSIS


Three group parallel, single-blind randomised controlled trial. Two comparison groups are included: aerobic exercise and a non-active wait-list control. In total, 180 participants aged 65-85 years will be recruited. Assessments will be performed at baseline and postintervention (12-week follow-up). The primary outcome is subjective well-being. Secondary outcomes include physical activity/sedentary behaviour, mobility/fall risk, cognition, depression, anxiety, mood, stress, pain, sleep quality, social support and cardiometabolic risk factors. Data will be analysed using intention-to-treat analyses, with mixed linear modelling.
ETHICS AND DISSEMINATION


This study is approved by the Ethical Review Board in Stockholm (2017/1862-31/2). All participants must voluntarily agree to participate and are free to withdraw from the study at any point. Written informed consent will be obtained from each participant prior to inclusion. Results will be available through research articles and conferences. A summary of key results will be publicly available through newspaper articles.
TRIAL REGISTRATION NUMBER


DRKS00015093, U1111-1217-4248.",2019,"Secondary outcomes include physical activity/sedentary behaviour, mobility/fall risk, cognition, depression, anxiety, mood, stress, pain, sleep quality, social support and cardiometabolic risk factors.","['180 participants aged 65-85 years will be recruited', 'U1111-1217-4248', 'physically inactive older adults', 'older adults']",['aerobic exercise and a non-active wait-list control'],"['physical activity/sedentary behaviour, mobility/fall risk, cognition, depression, anxiety, mood, stress, pain, sleep quality, social support and cardiometabolic risk factors', 'subjective well-being']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0037438'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",180.0,0.120932,"Secondary outcomes include physical activity/sedentary behaviour, mobility/fall risk, cognition, depression, anxiety, mood, stress, pain, sleep quality, social support and cardiometabolic risk factors.","[{'ForeName': 'Josefine', 'Initials': 'J', 'LastName': 'Östh', 'Affiliation': 'Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Diwan', 'Affiliation': 'Department of Public Health Sciences, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Jirwe', 'Affiliation': 'Department of Health Promoting Sciences, Sophiahemmet Hogskola, Stockholm, Sweden.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Diwan', 'Affiliation': 'Department of Public Health and Environment, International Centre for Health Research, Ruxmaniben Deepchand Gardi Medical College, Ujjain, Madhya Pradesh, India.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Choudhary', 'Affiliation': 'Department of Physiology, Ruxmaniben Deepchand Gardi Medical College, Ujjain, Madhya Pradesh, India.'}, {'ForeName': 'Vijay Khanderao', 'Initials': 'VK', 'LastName': 'Mahadik', 'Affiliation': 'Department of Physiology, Ruxmaniben Deepchand Gardi Medical College, Ujjain, Madhya Pradesh, India.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Pascoe', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Hallgren', 'Affiliation': 'Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.'}]",BMJ open,['10.1136/bmjopen-2018-027386']
2007,32107265,Effectiveness of a clinic-based randomized controlled intervention for type 2 diabetes management: an innovative model of intensified diabetes management in Mainland China (C-IDM study).,"OBJECTIVES


Highly efficient diabetes management programs are needed for tackling diabetes in China. This study aimed to assess the effectiveness of a clinic-based intensified diabetes management model (C-IDM) in Mainland China.
RESEARCH DESIGN AND METHODS


A 2-year clinic-based randomized controlled trial was conducted among patients with type 2 diabetes in Nanjing, China. The C-IDM intervention components comprised four domains (disease targeting management, express referral channel, expert visit, patients' self-management) and an integrated running system (disease control centers, general hospitals and local clinics). Control group participants received their usual care, while intervention participants received both the C-IDM package and the usual services. The primary outcome variable was change of hemoglobin A1c (HbA1c). Mixed-effects models were used to compute effect estimates and 95% CI with consideration of both individual and cluster-level confounders.
RESULTS


Overall, 1095 of 1143 participants were assessed at study completion. The mean change in HbA1c was significantly greater in the intervention group than in the control group (mean difference (MD)=-0.57, 95% CI -0.79 to -0.36). Similar results were observed for change in body mass index (MD=-0.29, 95% CI -0.49 to -0.10). Participants in the intervention group were more likely to achieve normal HbA1c and body weight compared with their counterparts in control group after adjusting for potentially confounding variables (adjusted OR=1.94, 95% CI 1.35 to 2.81 and 1.79, 95% CI 1.13 to 2.85, respectively).
CONCLUSIONS


The C-IDM model is feasible and effective in large-scale management of patients with type 2 diabetes in China. It has public health implications for tackling the burden of diabetes in China.
TRIAL REGISTRATION NUMBER


ChiCTR-IOR-15006019.",2020,"Participants in the intervention group were more likely to achieve normal HbA1c and body weight compared with their counterparts in control group after adjusting for potentially confounding variables (adjusted OR=1.94, 95% CI 1.35 to 2.81 and 1.79, 95% CI 1.13 to 2.85, respectively).
","['patients with type 2 diabetes in China', 'patients with type 2 diabetes in Nanjing, China', 'type 2 diabetes management']","['usual care, while intervention participants received both the C-IDM package and the usual services', 'clinic-based randomized controlled intervention', 'clinic-based intensified diabetes management model (C-IDM']","['normal HbA1c and body weight', 'change of hemoglobin A1c (HbA1c', 'mean change in HbA1c', 'body mass index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",1143.0,0.10842,"Participants in the intervention group were more likely to achieve normal HbA1c and body weight compared with their counterparts in control group after adjusting for potentially confounding variables (adjusted OR=1.94, 95% CI 1.35 to 2.81 and 1.79, 95% CI 1.13 to 2.85, respectively).
","[{'ForeName': 'Qinglin', 'Initials': 'Q', 'LastName': 'Lou', 'Affiliation': 'Geriatric Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Ye', 'Affiliation': 'Non-Communicable Disease Prevention and Control, Nanjing Municipal Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Haidi', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Geriatric Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Non-Communicable Disease Prevention and Control, Nanjing Municipal Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Ware', 'Affiliation': 'Griffith University Menzies Health Institute Queensland, Nathan, Queensland, Australia.'}, {'ForeName': 'Yaqing', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': 'Geriatric Hospital of Nanjing Medical University, Nanjing, China xiongyaqingnj@126.com f.xufei@gmail.com.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Non-Communicable Disease Prevention and Control, Nanjing Municipal Center for Disease Control and Prevention, Nanjing, China xiongyaqingnj@126.com f.xufei@gmail.com.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-001030']
2008,32168551,"A double-blind, randomized, multicenter phase 3 study of palonosetron vs granisetron combined with dexamethasone and fosaprepitant to prevent chemotherapy-induced nausea and vomiting in patients with breast cancer receiving anthracycline and cyclophosphamide.","PURPOSE


To investigate whether palonosetron is better than granisetron in preventing chemotherapy-induced nausea and vomiting (CINV) in a three-drug combination with dexamethasone and fosaprepitant (Fos) in patients with breast cancer who are placed on anthracycline and cyclophosphamide (AC-based regimen).
PATIENTS AND METHODS


Chemo-naive women with primary breast cancer were randomly administered either palonosetron 0.75 mg (day 1) or granisetron 1 mg (day 1) combined with dexamethasone (12 mg at day 1, 8 mg at day 2 and day 3) and Fos 150 mg (day 1) before receiving AC-based regimen in a double-blind study. The primary endpoint was the complete response (CR) rate of emesis in cycle 1 in the delayed phase. This was defined as neither vomiting nor rescue drug usage for emesis at >24-120 hours after chemotherapy. Secondary endpoints were the CR in the acute/overall phase (0-24/0-120 hours, respectively, after chemotherapy), no nausea and vomiting, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and safety.
RESULTS


From December 2012 to October 2014, 326 patients were treated and evaluated (164/162 evaluable patients in granisetron/palonosetron arm, respectively). The CR during the delayed phase was 60.4% in the granisetron regimen and 62.3% in the palonosetron regimen. The CR during acute phase (73.2% vs 75.9%, respectively) and the CR during overall phase (54.9% in both regimens) were very identical. A significantly higher number of patients in the palonosetron arm were free from nausea during the delayed phase (28% vs 40.1%; P = .029). Adverse events were also identical, although infusion site reactions (ISR) were higher (20.3%-23.3%) than preceding studies in both regimens.
CONCLUSION


In combination with dexamethasone and Fos, this study suggests that palonosetron is not better than granisetron in chemo-naive patients with primary breast cancer receiving AC-based regimen. Administration of Fos in peripheral veins after AC-based regimen increased ISR.",2020,"Adverse events were also identical, although infusion site reactions (ISR) were higher (20.3%-23.3%) than preceding studies in both regimens.
","['chemo-naive patients with primary breast cancer receiving AC-based regimen', 'From December 2012 to October 2014, 326 patients were treated and evaluated (164/162 evaluable patients in granisetron/palonosetron arm, respectively', 'patients with breast cancer receiving', 'patients with breast cancer who are placed on anthracycline and cyclophosphamide (AC-based regimen', 'Chemo-naive women with primary breast cancer']","['palonosetron', 'anthracycline and cyclophosphamide', 'dexamethasone and fosaprepitant (Fos', 'dexamethasone and fosaprepitant', 'dexamethasone', 'granisetron', 'palonosetron vs granisetron', 'palonosetron 0.75\xa0mg (day 1) or granisetron 1\xa0mg (day 1) combined with dexamethasone']","['CR in the acute/overall phase', 'nausea and vomiting (CINV', 'Adverse Events (PRO-CTCAE), and safety', 'infusion site reactions (ISR', 'vomiting nor rescue drug usage for emesis', 'Adverse events', 'complete response (CR) rate of emesis', 'nausea and vomiting', 'ISR', 'nausea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0061863', 'cui_str': 'Granisetron'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2349941', 'cui_str': 'fosaprepitant'}, {'cui': 'C0061863', 'cui_str': 'Granisetron'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1123248', 'cui_str': 'Granisetron 1 MG'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1096343', 'cui_str': 'Infusion Site Adverse Event'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",326.0,0.102963,"Adverse events were also identical, although infusion site reactions (ISR) were higher (20.3%-23.3%) than preceding studies in both regimens.
","[{'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Matsumoto', 'Affiliation': 'Hyogo Cancer Center, Hyogo, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'NHO Hokkaido Cancer Center, Hokkaido, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Tokyo-West Tokushukai Hospital, Tokyo, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Osaki', 'Affiliation': 'Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Takano', 'Affiliation': 'Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Naito', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Matsuura', 'Affiliation': 'Hiroshima Prefectural Hospital, Hiroshima, Japan.'}, {'ForeName': 'Kenjiro', 'Initials': 'K', 'LastName': 'Aogi', 'Affiliation': 'Shikoku Cancer Center, Ehime, Japan.'}, {'ForeName': 'Kimiko', 'Initials': 'K', 'LastName': 'Fujiwara', 'Affiliation': 'Kindai University Hospital, Osaka, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Motoi', 'Initials': 'M', 'LastName': 'Baba', 'Affiliation': 'Hokkaido University, Hokkaido, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Tokunaga', 'Affiliation': 'Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Gen', 'Initials': 'G', 'LastName': 'Hirano', 'Affiliation': 'Kyushu Hospital, Fukuoka, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Imoto', 'Affiliation': 'Kyorin University, Tokyo, Japan.'}, {'ForeName': 'Chieko', 'Initials': 'C', 'LastName': 'Miyazaki', 'Affiliation': 'Jichi Medical University, Tochigi, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Yanagihara', 'Affiliation': 'Kansai Electric Power Hospital, Osaka, Japan.'}, {'ForeName': 'Chiyo K', 'Initials': 'CK', 'LastName': 'Imamura', 'Affiliation': 'Advanced Cancer Translational Research Institute, Showa University, Tokyo, Japan.'}, {'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Chiba', 'Affiliation': 'Kindai University Hospital, Osaka, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Saeki', 'Affiliation': 'Saitama Medical University, Saitama, Japan.'}]",Cancer medicine,['10.1002/cam4.2979']
2009,31452311,Haemoconcentration during treatment of acute heart failure with cardiorenal syndrome: from the CARRESS-HF trial.,,2019,,['acute heart failure with cardiorenal syndrome'],['Haemoconcentration'],[],"[{'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C2242703', 'cui_str': 'Renocardiac Syndrome'}]","[{'cui': 'C0854379', 'cui_str': 'Haemoconcentration'}]",[],,0.0425089,,"[{'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Blumer', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Greene', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Jie-Lena', 'Initials': 'JL', 'LastName': 'Sun', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Bart', 'Affiliation': 'Division of Cardiology, Hennepin County Medical Center, Minneapolis, MN, USA.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Ambrosy', 'Affiliation': 'Division of Cardiology, The Permanente Medical Group, San Francisco, CA, USA.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Marat', 'Initials': 'M', 'LastName': 'Fudim', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'McNulty', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC, USA.'}]",European journal of heart failure,['10.1002/ejhf.1592']
2010,31644499,Male Partner Linkage to Clinic-Based Services for Sexually Transmitted Infections and Human Immunodeficiency Virus Services Following Couple Home-Based Education and Testing.,"BACKGROUND


Home-based human immunodeficiency virus (HIV) testing and education has increased HIV test uptake and access to health services among men. We studied how a home-based antenatal intervention influenced male partner utilization of clinic-based HIV and sexually transmitted infection (STI) services, linkage to HIV care and medical circumcision.
METHODS


We conducted a secondary analysis within a randomized controlled trial of pregnant women attending antenatal care in Kenya. Women and their male partners received either a home-based couple intervention or an invitation letter for clinic-based couple HIV testing. The home-based intervention included education on STI symptoms, STI and HIV treatment and male circumcision for HIV prevention. Male self-reported outcomes were compared using relative risks at 6 months postpartum.
RESULTS


Among 525 women, we reached 487 (93%) of their male partners; 247 men in the intervention arm and 240 men in the control arm. Men who received the intervention were more likely to report an STI consultation (n = 47 vs. 16; relative risk, 1.59; 95% confidence interval, 1.33-1.89). Among 23 men with newly diagnosed HIV, linkage to HIV care was reported by 4 of 15 in the intervention (3 men had missing linkage data) and 3 of 5 men in the control arms (relative risk, 0.66; 95% confidence interval, 0.34-1.29). Although the intervention identified 3 times more men with new HIV infection, the study lacked power to find significant differences in linkage to HIV care. Few eligible men sought medical circumcision (4 of 72 intervention and 2 of 88 control).
CONCLUSIONS


Home-based couple education and testing increased STI consultations among male partners of pregnant women, but appeared insufficient to overcome the barriers involved in linkage to HIV care and medical circumcision.",2019,"Men who received the intervention were more likely to report an STI consultation (n = 47 vs. 16; relative risk, 1.59; 95% confidence interval, 1.33-1.89).","['23 men with newly diagnosed HIV', 'pregnant women attending antenatal care in Kenya', 'Women and their male partners', 'Male Partner Linkage to Clinic-Based Services for Sexually Transmitted Infections and Human Immunodeficiency Virus Services', 'Few eligible men sought medical circumcision (4 of 72 intervention and 2 of 88 control', 'male partners of pregnant women', '525 women, we reached 487 (93%) of their male partners; 247 men in the intervention arm and 240 men in the control arm', 'men']","['home-based couple intervention or an invitation letter for clinic-based couple HIV testing', 'home-based antenatal intervention']","['male partner utilization of clinic-based HIV and sexually transmitted infection (STI) services', 'likely to report an STI consultation', 'STI consultations']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0403327', 'cui_str': 'Ritual circumcision (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}]","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]",525.0,0.0621027,"Men who received the intervention were more likely to report an STI consultation (n = 47 vs. 16; relative risk, 1.59; 95% confidence interval, 1.33-1.89).","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Mark', 'Affiliation': 'From the Department of Epidemiology, University of Washington, Seattle, WA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kinuthia', 'Affiliation': 'Department of Research and Programs.'}, {'ForeName': 'Alfred O', 'Initials': 'AO', 'LastName': 'Osoti', 'Affiliation': 'From the Department of Epidemiology, University of Washington, Seattle, WA.'}, {'ForeName': 'Molly A', 'Initials': 'MA', 'LastName': 'Gone', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Nairobi.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Asila', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Nairobi.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Krakowiak', 'Affiliation': 'From the Department of Epidemiology, University of Washington, Seattle, WA.'}, {'ForeName': 'Monisha', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'From the Department of Epidemiology, University of Washington, Seattle, WA.'}, {'ForeName': 'Saloni', 'Initials': 'S', 'LastName': 'Parikh', 'Affiliation': 'Computer Science and Engineering and Public Health.'}, {'ForeName': 'Quy T', 'Initials': 'QT', 'LastName': 'Ton', 'Affiliation': 'Allina Health, Minneapolis, MN.'}, {'ForeName': 'Barbra A', 'Initials': 'BA', 'LastName': 'Richardson', 'Affiliation': 'Department of Biostatistics.'}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Farquhar', 'Affiliation': 'From the Department of Epidemiology, University of Washington, Seattle, WA.'}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Roxby', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA.'}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001057']
2011,31825940,Hypertension with Hyperhomocysteinemia Increases the Risk of Early Cognitive Impairment after First-Ever Ischemic Stroke.,"BACKGROUND


Hypertension and hyperhomocysteinemia (HHcy) are independent risk factors of stroke and are associated with each other. Although evidence suggests that they are related to cognitive impairment, the relationship between hypertension accompanied with HHcy and poststroke cognitive impairment (PSCI) is unclear.
OBJECTIVE


To define the relationship between hypertension with HHcy and early cognitive impairment after acute cerebral infarction.
MATERIALS AND METHODS


Our study enrolled 232 patients with acute first-ever ischemic stroke. Patients were assigned to 3 groups by blood pressure and homocysteine (Hcy) levels: hypertension with HHcy, simple hypertension, or control. Cognition was assessed by the Montreal cognitive assessment at admission and at 3- and 6-month follow-ups.
RESULTS


The hypertension with HHcy group exhibited the highest incidence of early cognitive impairment (simple hypertension: p = 0.000; control: p = 0.000). This group also had lower visual space/executive scores than the simple hypertension group (p = 0.000) and lower delayed recall scores than the control group (p = 0.011). Multivariate analysis showed that hypertension with HHcy (OR 7.797; 95% CI 2.917-20.843; p = 0.000), the level of serum Hcy (OR 1.063; 95% CI 1.109-1.109; p = 0.005), education years (OR 0.797; 95% CI 0.722-0.880; p = 0.000), and Fazekas scale of leukoaraiosis (OR 1.648; 95% CI 1.239-2.191; p = 0.001) were independent influencing factors of early PSCI; however, simple hypertension (OR 1.183, 95% CI 0.208-6.737; p = 0.850) and simple HHcy (OR 1.112, 95% CI 0.181-6.810; p = 0.909) were not.
CONCLUSION


Patients with both hypertension and HHcy are at an increased risk of early cognitive impairment after acute first-ever ischemic stroke.",2019,The hypertension with HHcy group exhibited the highest incidence of early cognitive impairment (simple hypertension: p = 0.000; control: p = 0.000).,['232 patients with acute first-ever ischemic stroke'],[],"['early cognitive impairment', 'risk of early cognitive impairment', 'blood pressure and homocysteine (Hcy) levels: hypertension with HHcy, simple hypertension, or control', 'Risk of Early Cognitive Impairment', 'delayed recall scores', 'Fazekas scale of leukoaraiosis', 'lower visual space/executive scores', 'simple HHcy', 'level of serum Hcy', 'simple hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}]",[],"[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement (procedure)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0948163', 'cui_str': 'Leukoaraiosis'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",232.0,0.0442313,The hypertension with HHcy group exhibited the highest incidence of early cognitive impairment (simple hypertension: p = 0.000; control: p = 0.000).,"[{'ForeName': 'Zhen-Hui', 'Initials': 'ZH', 'LastName': 'Lu', 'Affiliation': 'Department of Neurology, Second Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Second Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Xin-Ling', 'Initials': 'XL', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Second Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Ding', 'Affiliation': 'Department of Neurology, Second Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Cheng-Jie', 'Initials': 'CJ', 'LastName': 'Mao', 'Affiliation': 'Department of Neurology, Second Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Xiang-Yang', 'Initials': 'XY', 'LastName': 'Zhu', 'Affiliation': 'Department of Neurology, Second Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Chun-Feng', 'Initials': 'CF', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Second Affiliated Hospital of Soochow University, Suzhou, China, liuchunfeng@suda.edu.cn.'}]",European neurology,['10.1159/000504704']
2012,32174572,Comparative clinical trial of intracameral ropivacaine vs. lignocaine in subjects undergoing phacoemulsification under augmented topical anesthesia.,"Purpose


To compare intracameral Ropivacaine to Lignocaine during phacoemulsification under augmented topical anesthesia, in terms of efficacy and safety.
Methods


This prospective, randomized, double-masked clinical trial included subjects planned for phacoemulsification with posterior chamber intraocular lens implantation for visually significant uncomplicated senile cataract, under augmented topical anesthesia. Cases were randomized into two groups, Group A (Ropivacaine 0.1%) or Group B (Lignocaine 1.0%). The pain experienced by the patients during the surgery, mydriasis, post-op inflammation and endothelial cell change at six weeks after the procedure was evaluated. Surgeon's feedback was recorded to evaluate the cooperation of the patient during surgery.
Results


A total of 210 subjects were screened and 184 were randomized to have 92 subjects in each group. There was no statistically significant difference seen on comparing Group A and B with respect to Age (P = 0.05), painful surgical steps (P = 0.85), visual analog scale scores (P = 0.65), surgeon's score (P = 0.11), postoperative inflammation (P = 0.90) and average ultrasound time during phacoemulsification (P = 0.10). Subjects in Group A fared better when compared to Group B with respect to endothelial cell loss (P = 0.0008), and augmentation in mydriasis (P < 0.001).
Conclusion


Intracameral Ropivacaine and Lignocaine, both are equally effective in providing analgesia during phacoemulsification. However, intracameral Ropivacaine is superior to Lignocaine with regards to corneal endothelial cell safety, and augmenting mydriasis.",2020,"There was no statistically significant difference seen on comparing Group A and B with respect to Age (P = 0.05), painful surgical steps (P = 0.85), visual analog scale scores (P = 0.65), surgeon's score (P = 0.11), postoperative inflammation (P = 0.90) and average ultrasound time during phacoemulsification (P = 0.10).","['subjects undergoing phacoemulsification under augmented topical anesthesia', 'A total of 210 subjects were screened and 184 were randomized to have 92 subjects in each group']","['intracameral ropivacaine vs. lignocaine', 'Ropivacaine', 'Lignocaine', 'topical anesthesia', 'phacoemulsification with posterior chamber intraocular lens implantation', 'intracameral Ropivacaine', 'Group A (Ropivacaine 0.1%) or Group B (Lignocaine']","['efficacy and safety', 'visual analog scale scores', 'corneal endothelial cell safety', 'average ultrasound time', 'augmentation in mydriasis', 'painful surgical steps', 'endothelial cell loss', 'postoperative inflammation', ""surgeon's score""]","[{'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C1298763', 'cui_str': 'Implantation of posterior chamber intraocular lens'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0225336', 'cui_str': 'Endothelial Cells'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0026961', 'cui_str': 'Mydriasis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",210.0,0.040708,"There was no statistically significant difference seen on comparing Group A and B with respect to Age (P = 0.05), painful surgical steps (P = 0.85), visual analog scale scores (P = 0.65), surgeon's score (P = 0.11), postoperative inflammation (P = 0.90) and average ultrasound time during phacoemulsification (P = 0.10).","[{'ForeName': 'Arun K', 'Initials': 'AK', 'LastName': 'Sharma', 'Affiliation': ""Department of Ophthalmology, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': ""Department of Ophthalmology, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Hansraj', 'Affiliation': 'Mansarovar Eye Hospital, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Ajai K', 'Initials': 'AK', 'LastName': 'Gupta', 'Affiliation': 'Jan Kalyan Eye Hospital, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': ""Department of Ophthalmology, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Katiyar', 'Affiliation': ""Department of Ophthalmology, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Sanjiv K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': ""Department of Ophthalmology, King George's Medical University, Lucknow, Uttar Pradesh, India.""}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_1388_19']
2013,31061025,Protocol: randomised trial to compare nasoduodenal tube and nasogastric tube feeding in infants with bronchiolitis on high-flow nasal cannula; Bronchiolitis and High-flow nasal cannula with Enteral Tube feeding Randomised (BHETR) trial.,"INTRODUCTION


High-flow nasal cannula (HFNC) is a non-invasive form of respiratory support used increasingly in bronchiolitis. HFNC provides a variable amount of positive pressure similar to continuous positive airway pressure (CPAP). The positive pressure in CPAP can distend and loosen oesophageal sphincter pressure leading to increased reflux. It is unclear if HFNC causes a similar action. Feeding tubes are used to provide nutrition and hydration to patients that are unable to safely take oral feedings. If there is increased reflux from HFNC, this would increase the risk of aspiration. Our institution places nasoduodenal tubes (NDT) to eliminate this risk. The purpose of the study is to infer if there is a difference between NDT and nasogastric tube (NGT) feeding with regard to length of respiratory support, number of emesis, number of chest X-rays and readmission/emergency room revisit rates.
METHODS AND ANALYSIS


Patients with bronchiolitis, on high-flow nasal cannula, and whose primary physicians have decided on feeding tube for nutrition/hydration will be approached for consent and enrolment. Patients will be randomised to NGT or NDT in variable block sizes and stratified into low- and high-risk groups. Outcomes will be analysed by both a frequentist and Bayesian statistical approach.
ETHICS AND DISSEMINATION


The trial was approved by local institutional review board. Every attempt will be made to reduce to an absolute minimum the interval between completion of data collection and release of study results through appropriate dissemination mediums including abstracts, poster presentations and journal publications.
TRIAL REGISTRATION NUMBER


NCT03346850; Pre-results.",2019,Patients will be randomised to NGT or NDT in variable block sizes and stratified into low- and high-risk groups.,"['Patients with bronchiolitis, on high-flow nasal cannula, and whose primary physicians have decided on feeding tube for nutrition/hydration will be approached for consent and enrolment', 'infants with bronchiolitis on high-flow nasal cannula; Bronchiolitis and High-flow nasal cannula with Enteral Tube feeding Randomised (BHETR) trial']","['NGT or NDT', 'NDT and nasogastric tube (NGT', 'High-flow nasal cannula (HFNC', 'HFNC', 'nasoduodenal tube and nasogastric tube feeding']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006271', 'cui_str': 'Bronchiolitis'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C2945625', 'cui_str': 'Feeding tube, device (physical object)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0041281', 'cui_str': 'Tube Feeding'}]","[{'cui': 'C0085678', 'cui_str': 'Nasogastric tube, device (physical object)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0192456', 'cui_str': 'Nasogastric tube feeding'}]",[],,0.0845659,Patients will be randomised to NGT or NDT in variable block sizes and stratified into low- and high-risk groups.,"[{'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Parlar-Chun', 'Affiliation': 'University of Texas John P and Katherine G McGovern Medical School, Houston, Texas, USA.'}, {'ForeName': 'Meaghan', 'Initials': 'M', 'LastName': 'Lafferty-Prather', 'Affiliation': 'University of Texas John P and Katherine G McGovern Medical School, Houston, Texas, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Gonzalez', 'Affiliation': 'University of Texas John P and Katherine G McGovern Medical School, Houston, Texas, USA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pedroza', 'Affiliation': 'Centre for Clinical Research and Evidence-Based Medicine, McGovern Medical School at The University of Texas Health Science Centre, Houston, Texas, USA.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Gourishankar', 'Affiliation': 'Pediatrics, University of Texas John P and Katherine G McGovern Medical School, Houston, Texas, USA.'}]",BMJ open,['10.1136/bmjopen-2018-025405']
2014,32068667,"A randomized placebo-controlled trial of desipramine, cognitive behavioral therapy, and active placebo therapy for low back pain.","This clinical trial evaluated the independent and combined effects of a tricyclic antidepressant (desipramine) and cognitive behavioral therapy (CBT) for chronic back pain relative to an active placebo treatment. Participants (n = 142) were patients experiencing daily chronic back pain at an intensity of ≥4/10 who were randomized to a single-center, double-blind, 12-week, 4-arm, parallel groups controlled clinical trial of (1) low concentration desipramine titrated to reach a serum concentration level of 15 to 65 ng/mL; (2) CBT and active placebo medication (benztropine mesylate, 0.125 mg); (3) low concentration desipramine and CBT; and (4) active benztropine placebo medication. Participants completed the Differential Description Scale and Roland Morris Disability Questionnaires before and after treatment as validated measures of outcomes in back pain intensity and disability, respectively. Participants within each condition showed significant reductions from pre-treatment to post-treatment in pain intensity (mean changes ranged from = -2.58 to 3.87, Cohen's d's = 0.46-0.84) and improvements in pain disability (mean changes = -3.04 to 4.29, Cohen's d's = 0.54-0.88). However, intent-to-treat analyses at post-treatment showed no significant differences between any condition, with small effect sizes ranging from 0.06 to 0.27. The results from this clinical trial did not support the hypothesis that desipramine, CBT, or their combination would be statistically superior to an active medicine placebo for reducing chronic back pain intensity or disability. Key limitations included recruiting 71% of the planned sample size and use of multiple inclusion/exclusion criteria that may limit generalizability to broader populations of patients with chronic back pain.",2020,"Participants within each condition showed significant reductions from pre to post-treatment in pain intensity (mean changes ranged from = -2.58-3.87, Cohen's d's = 0.46-0.84) and improvements in pain disability (mean changes = -3.04-4.29, Cohen's d's = 0.54-0.88).","['patients with chronic back pain', 'low back pain', 'Participants (n=142) were patients experiencing daily chronic back pain at an intensity of ≥4/10 who']","['medicine placebo', 'tricyclic antidepressant (desipramine) and cognitive behavioral therapy (CBT', 'desipramine, CBT', 'placebo', 'CBT and active placebo medication (benzotropine mesylate, 0.125mg); 3) low concentration desipramine and CBT; and 4) active benztropine placebo medication', 'desipramine, cognitive behavioral therapy, and active placebo therapy', 'low concentration desipramine']","['Differential Description Scale and Roland-Morris Disability Questionnaires pre', 'pain intensity', 'pain disability', 'chronic back pain intensity or disability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain (finding)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003290', 'cui_str': 'Antidepressant Drugs, Tricyclic'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0011685', 'cui_str': 'Desipramine'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3645051', 'cui_str': 'mesylate'}, {'cui': 'C4517427', 'cui_str': '0.125 (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0005098', 'cui_str': 'benzatropine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain (finding)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",142.0,0.562883,"Participants within each condition showed significant reductions from pre to post-treatment in pain intensity (mean changes ranged from = -2.58-3.87, Cohen's d's = 0.46-0.84) and improvements in pain disability (mean changes = -3.04-4.29, Cohen's d's = 0.54-0.88).","[{'ForeName': 'Hilary M', 'Initials': 'HM', 'LastName': 'Gould', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States.'}, {'ForeName': 'Joseph Hampton', 'Initials': 'JH', 'LastName': 'Atkinson', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Chircop-Rollick', 'Affiliation': 'University of California, San Diego, CA, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'DʼAndrea', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Garfin', 'Affiliation': 'University of California, San Diego, CA, United States.'}, {'ForeName': 'Shetal M', 'Initials': 'SM', 'LastName': 'Patel', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Funk', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States.'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'University of California, San Diego, CA, United States.'}, {'ForeName': 'Donald B', 'Initials': 'DB', 'LastName': 'Penzien', 'Affiliation': 'Wake Forest School of Medicine, Winston Salem, NC, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wallace', 'Affiliation': 'University of California, San Diego, CA, United States.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Weickgenanta', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Slater', 'Affiliation': 'HonorHealth Research Institute, Scottsdale, AZ, United States.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rutledge', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States.'}]",Pain,['10.1097/j.pain.0000000000001834']
2015,30988146,Efficacy and Safety of Tedizolid Phosphate versus Linezolid in a Randomized Phase 3 Trial in Patients with Acute Bacterial Skin and Skin Structure Infection.,"Tedizolid phosphate is approved for the treatment of acute bacterial skin and skin structure infection (ABSSSI) caused by Gram-positive bacteria in the United States, Europe, and other countries. In this multicenter, double-blind, phase 3 study, 598 adult ABSSSI patients in China, Taiwan, the Philippines, and the United States were randomized to receive 200 mg of tedizolid, intravenously (i.v.)/orally (p.o.), once daily for 6 days or 600 mg of linezolid, i.v./p.o. twice daily for 10 days. The primary endpoint was early clinical response rate at 48 to 72 h. Secondary endpoints included programmatic and investigator-assessed outcomes at end-of-therapy (EOT) and posttherapy evaluation (PTE) visits. Safety was also evaluated. In the intent-to-treat (ITT) population, 75.3% of tedizolid-treated patients and 79.9% of linezolid-treated patients were early responders (treatment difference, -4.6%; 95% confidence interval [CI], -11.2, 2.2). After exclusion of patients who never received the study drug (tedizolid,  n  = 8; linezolid,  n  = 1; modified ITT), comparable early response rates were observed (tedizolid, 77.4%; linezolid, 80.1%; treatment difference, -2.7%; 95% CI, -9.4, 3.9). Secondary endpoints showed high and similar clinical success rates in the ITT and clinically evaluable (CE) populations at EOT and PTE visits (e.g., CE-PTE for tedizolid, 90.4%; for linezolid, 93.5%). Both drugs were well tolerated, and no death occurred. Eight patients experienced phlebitis with tedizolid while none did with linezolid; hence, drug-related treatment-emergent adverse events were reported in a slightly higher proportion in the tedizolid (20.9%) arm than in the linezolid arm (15.8%). The study demonstrated that tedizolid in a primarily Asian population was an efficacious and well-tolerated treatment option for ABSSSI patients. (This study has been registered at ClinicalTrials.gov under registration no. NCT02066402.).",2019,"Tedizolid phosphate is approved for the treatment of acute bacterial skin and skin structure infection (ABSSSI) caused by Gram-positive bacteria in the United States, Europe, and other countries.","['Patients with Acute Bacterial Skin and Skin Structure Infection', '598 adult ABSSSI patients in China, Taiwan, the Philippines, and the United States']","['linezolid', '200\u2009mg of tedizolid', 'tedizolid', 'Tedizolid Phosphate versus Linezolid', 'Tedizolid phosphate', 'linezolid,  n \u2009=\u20091; modified ITT']","['clinical success rates', 'programmatic and investigator-assessed outcomes at end-of-therapy (EOT) and posttherapy evaluation (PTE) visits', 'tolerated, and no death', 'phlebitis with tedizolid', 'Efficacy and Safety', 'early clinical response rate', 'early response rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4552481', 'cui_str': 'Acute bacterial skin and skin structure infection'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4552483', 'cui_str': 'ABSSSI'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}]","[{'cui': 'C0663241', 'cui_str': 'linezolid'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C2744850', 'cui_str': 'tedizolid'}, {'cui': 'C2930762', 'cui_str': 'tedizolid phosphate'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2744850', 'cui_str': 'tedizolid'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]",598.0,0.115322,"Tedizolid phosphate is approved for the treatment of acute bacterial skin and skin structure infection (ABSSSI) caused by Gram-positive bacteria in the United States, Europe, and other countries.","[{'ForeName': 'Xiaoju', 'Initials': 'X', 'LastName': 'Lv', 'Affiliation': 'Centre of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, China lvxj3369@163.com.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Alder', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Whippany, New Jersey, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': ""O'Riordan"", 'Affiliation': 'eStudy Site, Inc., San Diego, California, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Rybak', 'Affiliation': 'Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University School of Medicine, Detroit, Michigan, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Ye', 'Affiliation': 'Centre of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Ruiping', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Bayer HealthCare, Beijing, China.'}, {'ForeName': 'Zhongqi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Bayer HealthCare, Beijing, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Bayer HealthCare, Beijing, China.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Wilcox', 'Affiliation': 'Leeds Teaching Hospitals and University of Leeds, Leeds, United Kingdom.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.02252-18']
2016,32149427,Aromatic L-Amino Acid Decarboxylase Gene Therapy Enhances Levodopa Response in Parkinson's Disease.,"BACKGROUND


As Parkinson's disease progresses, levodopa treatment loses efficacy, partly through the loss of the endogenous dopamine-synthesizing enzyme L-amino acid decarboxylase (AADC). In the phase I PD-1101 study, putaminal administration of VY-AADC01, an investigational adeno-associated virus serotype-2 vector for delivery of the AADC gene in patients with advanced Parkinson's disease, was well tolerated, improved motor function, and reduced antiparkinsonian medication requirements.
OBJECTIVES


This substudy aimed to determine whether the timing and magnitude of motor response to intravenous levodopa changed in PD-1101 patients after VY-AADC01 administration.
METHODS


Participants received 2-hour threshold (0.6 mg/kg/h) and suprathreshold (1.2 mg/kg/h) levodopa infusions on each of 2 days, both before and approximately 6 months after VY-AADC01. Infusion order was randomized and double blinded. Unified Parkinson's Disease Rating Scale motor scores, finger-tapping speeds, and dyskinesia rating scores were assessed every 30 minutes for 1 hour before and ≥3 hours after start of levodopa infusion.
RESULTS


Of 15 PD-1101 patients, 13 participated in the substudy. Unified Parkinson's Disease Rating Scale motor score area under the curve responses to threshold and suprathreshold levodopa infusions increased by 168% and 67%, respectively, after VY-AADC01; finger-tapping speeds improved by 162% and 113%, and dyskinesia scores increased by 208% and 72%, respectively, after VY-AADC01. Adverse events (mild/moderate severity) were reported in 5 participants during levodopa infusions pre-VY-AADC01 and 2 participants post-VY-AADC01 administration.
CONCLUSIONS


VY-AADC01 improved motor responses to intravenous levodopa given under controlled conditions. These data and findings from the parent study support further clinical development of AADC gene therapy for people with Parkinson's disease. © 2020 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.",2020,"Unified Parkinson's Disease Rating Scale motor score area under the curve responses to threshold and suprathreshold levodopa infusions increased by 168% and 67%, respectively, after VY-AADC01; finger-tapping speeds improved by 162% and 113%, and dyskinesia scores increased by 208% and 72%, respectively, after VY-AADC01.","['2020', ""patients with advanced Parkinson's disease"", ""people with Parkinson's disease"", 'PD-1101 patients after VY-AADC01 administration', ""Parkinson's Disease"", 'Of 15 PD-1101 patients, 13 participated in the substudy']","['levodopa', 'Aromatic L-Amino Acid Decarboxylase Gene Therapy', 'levodopa infusions']","['dyskinesia scores', 'Adverse events', 'tapping speeds', 'Levodopa Response', ""Unified Parkinson's Disease Rating Scale motor score area under the curve responses to threshold and suprathreshold levodopa infusions"", 'motor responses', ""Unified Parkinson's Disease Rating Scale motor scores, finger-tapping speeds, and dyskinesia rating scores""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C1412028', 'cui_str': '5-Hydroxytryptophan Decarboxylase'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy (procedure)'}]","[{'cui': 'C1869094', 'cui_str': 'Dyskinesia (SMQ)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0222045'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1285623', 'cui_str': 'Motor response'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}]",,0.114359,"Unified Parkinson's Disease Rating Scale motor score area under the curve responses to threshold and suprathreshold levodopa infusions increased by 168% and 67%, respectively, after VY-AADC01; finger-tapping speeds improved by 162% and 113%, and dyskinesia scores increased by 208% and 72%, respectively, after VY-AADC01.","[{'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Nutt', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Curtze', 'Affiliation': 'Department of Biomechanics, University of Nebraska at Omaha, Omaha, Nebraska, USA.'}, {'ForeName': 'Amie', 'Initials': 'A', 'LastName': 'Hiller', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Anderson', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Larson', 'Affiliation': 'Department of Neurological Surgery, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Amber D', 'Initials': 'AD', 'LastName': 'Van Laar', 'Affiliation': 'Department of Neurology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'R Mark', 'Initials': 'RM', 'LastName': 'Richardson', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Marin E', 'Initials': 'ME', 'LastName': 'Thompson', 'Affiliation': 'Department of Neurological Surgery, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Sedkov', 'Affiliation': 'Voyager Therapeutics, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Leinonen', 'Affiliation': 'Clinical Data Science GmbH, Basel, Switzerland.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Ravina', 'Affiliation': 'Voyager Therapeutics, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Krystof S', 'Initials': 'KS', 'LastName': 'Bankiewicz', 'Affiliation': 'Department of Neurological Surgery, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Chadwick W', 'Initials': 'CW', 'LastName': 'Christine', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, California, USA.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.27993']
2017,31748596,Noisy galvanic vestibular stimulation has a greater ameliorating effect on posture in unstable subjects: a feasibility study.,"Ameliorating effect of noisy galvanic vestibular stimulation (nGVS) on posture varies among subjects. In this feasibility study, we investigated the association between original postural instability and the ameliorating effect of nGVS on posture. Data were collected in a previously published study. Thirty healthy elderly were recruited. Two nGVS sessions (30 min or 3 h) were performed in a randomised order. The optimal intensity of nGVS, the most effective intensity for improving posture, was determined before each session. Posture was measured for 30 s during and after nGVS in the eyes-closed/foam rubber condition. The velocity, envelopment area, and root mean square of the centre of pressure movement without nGVS were significantly larger in the group with an optimal intensity than those in the group without an optimal intensity. There was a significant positive correlation between these values and the long-term ameliorating effects. The ratio of the values in the eyes-closed/foam rubber condition to those in the eyes-open condition was significantly larger in the group with an optimal intensity, and had a significant correlation with the long-term ameliorating effects. The ameliorating effects are greater in subjects who were originally unstable and in those whose postural stability was relatively independent of vestibular input.",2019,"The velocity, envelopment area, and root mean square of the centre of pressure movement without nGVS were significantly larger in the group with an optimal intensity than those in the group without an optimal intensity.","['unstable subjects', 'subjects', 'Thirty healthy elderly were recruited']","['nGVS', 'Noisy galvanic vestibular stimulation', 'noisy galvanic vestibular stimulation (nGVS']","['velocity, envelopment area, and root mean square of the centre of pressure movement without nGVS']","[{'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",30.0,0.0313577,"The velocity, envelopment area, and root mean square of the centre of pressure movement without nGVS were significantly larger in the group with an optimal intensity than those in the group without an optimal intensity.","[{'ForeName': 'Chisato', 'Initials': 'C', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, Graduate School of Medicine, The University of Tokyo 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. cfujimoto-tky@umin.ac.jp.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, Graduate School of Medicine, The University of Tokyo 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Teru', 'Initials': 'T', 'LastName': 'Kamogashira', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, Graduate School of Medicine, The University of Tokyo 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Egami', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, Graduate School of Medicine, The University of Tokyo 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Kawahara', 'Affiliation': 'Biostatistics Division, Clinical Research Support Center, The University of Tokyo Hospital 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Uemura', 'Affiliation': 'Biostatistics Division, Clinical Research Support Center, The University of Tokyo Hospital 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Yoshiharu', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Educational Physiology Laboratory, Graduate School of Education, The University of Tokyo 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Yamasoba', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, Graduate School of Medicine, The University of Tokyo 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, Graduate School of Medicine, The University of Tokyo 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}]",Scientific reports,['10.1038/s41598-019-53834-7']
2018,31500466,Proresolving mediator profiles in cerebrospinal fluid are linked with disease severity and outcome in adults with tuberculous meningitis.,"Tuberculous meningitis (TBM) is the most lethal form of tuberculosis infection, characterized by a dysregulated immune response that frequently leads to neurologic injury and death despite the best available treatment. The mechanisms driving the inflammatory response in TBM are not well understood. To gain insights into these mechanisms, we used a lipid mediator-profiling approach to investigate the regulation of a novel group of host protective mediators, termed specialized proresolving mediators (SPMs), in the cerebrospinal fluid (CSF) of adults with TBM. Herein, using CSF from patients enrolled into a randomized placebo-controlled trial of adjunctive aspirin treatment, we found distinct lipid mediator profiles with increasing disease severity. These changes were linked with an up-regulation of inflammatory eicosanoids in patients with severe TBM and a decrease in the production of a number of SPMs. CSF proresolving mediator concentrations were also associated with 80-d survival. In survivors, we found a significant increase in proresolving mediator concentrations, including the lipoxygenase 5-derived 13-series resolvin (RvT)2, RvT4, and 15-epi-lipoxin B 4 , compared with those who died. Of note, treatment of patients with high-dose aspirin led to a decrease in the concentrations of the prothrombic mediator thromboxane A 2 , reduced brain infarcts, and decreased death in patients with TBM. Together, these findings identify a CSF SPM signature that is associated with disease severity and 80-d mortality in TBM.-Colas, R. A., Nhat, L. T. H., Thuong, N. T. T., Gómez, E. A., Ly, L., Thanh, H. H., Mai, N. T. H., Phu, N. H., Thwaites, G. E., Dalli, J. Proresolving mediator profiles in cerebrospinal fluid are linked with disease severity and outcome in adults with tuberculous meningitis.",2019,These changes were linked with an up-regulation of inflammatory eicosanoids in patients with severe TBM and a decrease in the production of a number of SPMs.,"['patients with TBM', 'patients with high-dose', 'adults with tuberculous meningitis', 'adults with TBM']","['placebo', 'adjunctive aspirin', 'aspirin']","['proresolving mediator concentrations', 'lipoxygenase 5-derived 13-series resolvin (RvT)2, RvT4, and 15-epi-lipoxin B 4', 'CSF proresolving mediator concentrations', 'concentrations of the prothrombic mediator thromboxane A 2 , reduced brain infarcts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041318', 'cui_str': 'Tubercular Meningitis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2936592', 'cui_str': 'Lipoxygenases'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}, {'cui': 'C0267963', 'cui_str': 'Pancreatic Insufficiency'}, {'cui': 'C0599689', 'cui_str': 'Lipoxins'}, {'cui': 'C0040061', 'cui_str': 'Thromboxanes'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}]",,0.0530299,These changes were linked with an up-regulation of inflammatory eicosanoids in patients with severe TBM and a decrease in the production of a number of SPMs.,"[{'ForeName': 'Romain A', 'Initials': 'RA', 'LastName': 'Colas', 'Affiliation': 'William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Le Thanh Hoang', 'Initials': 'LTH', 'LastName': 'Nhat', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Thuy Thuong', 'Initials': 'NTT', 'LastName': 'Thuong', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Esteban A', 'Initials': 'EA', 'LastName': 'Gómez', 'Affiliation': 'William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Ly', 'Affiliation': 'William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Hai Hoang', 'Initials': 'HH', 'LastName': 'Thanh', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Thi Hoang', 'Initials': 'NTH', 'LastName': 'Mai', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Hoan', 'Initials': 'NH', 'LastName': 'Phu', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Guy E', 'Initials': 'GE', 'LastName': 'Thwaites', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Jesmond', 'Initials': 'J', 'LastName': 'Dalli', 'Affiliation': 'William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.'}]",FASEB journal : official publication of the Federation of American Societies for Experimental Biology,['10.1096/fj.201901590R']
2019,31537373,Co-trimoxazole or multivitamin multimineral supplement for post-discharge outcomes after severe anaemia in African children: a randomised controlled trial.,"BACKGROUND


Severe anaemia is a leading cause of paediatric admission to hospital in Africa; post-discharge outcomes remain poor, with high 6-month mortality (8%) and re-admission (17%). We aimed to investigate post-discharge interventions that might improve outcomes.
METHODS


Within the two-stratum, open-label, multicentre, factorial randomised TRACT trial, children aged 2 months to 12 years with severe anaemia, defined as haemoglobin of less than 6 g/dL, at admission to hospital (three in Uganda, one in Malawi) were randomly assigned, using sequentially numbered envelopes linked to a second non-sequentially numbered set of allocations stratified by centre and severity, to enhanced nutritional supplementation with iron and folate-containing multivitamin multimineral supplements versus iron and folate alone at treatment doses (usual care), and to co-trimoxazole versus no co-trimoxazole. All interventions were administered orally and were given for 3 months after discharge from hospital. Separately reported randomisations investigated transfusion management. The primary outcome was 180-day mortality. All analyses were done in the intention-to-treat population; follow-up was 180 days. This trial is registered with the International Standard Randomised Controlled Trial registry, ISRCTN84086586, and follow-up is complete.
FINDINGS


From Sept 17, 2014, to May 15, 2017, 3983 eligible children were randomly assigned to treatment, and followed up for 180 days. 164 (4%) were lost to follow-up. 1901 (95%) of 1997 assigned multivitamin multimineral supplement, 1911 (96%) of 1986 assigned iron and folate, and 1922 (96%) of 1994 assigned co-trimoxazole started treatment. By day 180, 166 (8%) children in the multivitamin multimineral supplement group versus 169 (9%) children in the iron and folate group had died (hazard ratio [HR] 0·97, 95% CI 0·79-1·21; p=0·81) and 172 (9%) who received co-trimoxazole versus 163 (8%) who did not receive co-trimoxazole had died (HR 1·07, 95% CI 0·86-1·32; p=0·56). We found no evidence of interactions between these randomisations or with transfusion randomisations (p>0·2). By day 180, 489 (24%) children in the multivitamin multimineral supplement group versus 509 (26%) children in the iron and folate group (HR 0·95, 95% CI 0·84-1·07; p=0·40), and 500 (25%) children in the co-trimoxazole group versus 498 (25%) children in the no co-trimoxazole group (1·01, 0·89-1·15; p=0·85) had had one or more serious adverse events. Most serious adverse events were re-admissions, occurring in 692 (17%) children (175 [4%] with at least two re-admissions).
INTERPRETATION


Neither enhanced supplementation with multivitamin multimineral supplement versus iron and folate treatment or co-trimoxazole prophylaxis improved 6-month survival. High rates of hospital re-admission suggest that novel interventions are urgently required for severe anaemia, given the burden it places on overstretched health services in Africa.
FUNDING


Medical Research Council and Department for International Development.",2019,We found no evidence of interactions between these randomisations or with transfusion randomisations (p>0·2).,"['From Sept 17, 2014, to May 15, 2017, 3983 eligible children', 'children aged 2 months to 12 years with severe anaemia, defined as haemoglobin of less than 6 g/dL, at admission to hospital (three in Uganda, one in Malawi', 'African children']","['co-trimoxazole', 'sequentially numbered envelopes linked to a second non-sequentially numbered set of allocations stratified by centre and severity, to enhanced nutritional supplementation with iron and folate-containing multivitamin multimineral supplements versus iron and folate alone at treatment doses (usual care), and to co-trimoxazole versus no co-trimoxazole', 'trimoxazole started treatment', 'Co-trimoxazole or multivitamin multimineral supplement', 'multivitamin multimineral supplement versus iron and folate treatment or co-trimoxazole prophylaxis']","['6-month survival', 'serious adverse events', '180-day mortality']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}]","[{'cui': 'C0041044', 'cui_str': 'Sulfamethoxazole / Trimethoprim'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3661595', 'cui_str': 'Multivitamin multimineral supplement'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.276348,We found no evidence of interactions between these randomisations or with transfusion randomisations (p>0·2).,"[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Maitland', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK; Kenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya. Electronic address: k.maitland@imperial.ac.uk.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Olupot-Olupot', 'Affiliation': 'Busitema University Faculty of Health Sciences, Mbale Campus and Mbale Regional Referral Hospital Mbale, Mbale, Uganda.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kiguli', 'Affiliation': 'Department of Paediatrics, Makerere University and Mulago Hospital, Kampala, Uganda.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Chagaluka', 'Affiliation': 'College of Medicine, and Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Alaroker', 'Affiliation': 'Soroti Regional Referral Hospital, Soroti, Uganda.'}, {'ForeName': 'Robert O', 'Initials': 'RO', 'LastName': 'Opoka', 'Affiliation': 'Department of Paediatrics, Makerere University and Mulago Hospital, Kampala, Uganda.'}, {'ForeName': 'Ayub', 'Initials': 'A', 'LastName': 'Mpoya', 'Affiliation': 'Kenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Walsh', 'Affiliation': 'Nutrition Research Section, Imperial College London, London, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Engoru', 'Affiliation': 'Soroti Regional Referral Hospital, Soroti, Uganda.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Nteziyaremye', 'Affiliation': 'Busitema University Faculty of Health Sciences, Mbale Campus and Mbale Regional Referral Hospital Mbale, Mbale, Uganda.'}, {'ForeName': 'Machpherson', 'Initials': 'M', 'LastName': 'Mallewa', 'Affiliation': 'College of Medicine, and Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Kennedy', 'Affiliation': ""College of Medicine, and Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi; School of Medicine, Dentistry and Biomedical Science, Queen's University, Belfast, UK.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Nakuya', 'Affiliation': 'Soroti Regional Referral Hospital, Soroti, Uganda.'}, {'ForeName': 'Cate', 'Initials': 'C', 'LastName': 'Namayanja', 'Affiliation': 'Busitema University Faculty of Health Sciences, Mbale Campus and Mbale Regional Referral Hospital Mbale, Mbale, Uganda.'}, {'ForeName': 'Julianne', 'Initials': 'J', 'LastName': 'Kayaga', 'Affiliation': 'Department of Paediatrics, Makerere University and Mulago Hospital, Kampala, Uganda.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Nabawanuka', 'Affiliation': 'Department of Paediatrics, Makerere University and Mulago Hospital, Kampala, Uganda.'}, {'ForeName': 'Tonny', 'Initials': 'T', 'LastName': 'Sennyondo', 'Affiliation': 'Busitema University Faculty of Health Sciences, Mbale Campus and Mbale Regional Referral Hospital Mbale, Mbale, Uganda.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Aromut', 'Affiliation': 'Soroti Regional Referral Hospital, Soroti, Uganda.'}, {'ForeName': 'Felistas', 'Initials': 'F', 'LastName': 'Kumwenda', 'Affiliation': 'College of Medicine, and Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Cynthia Williams', 'Initials': 'CW', 'LastName': 'Musika', 'Affiliation': 'Department of Paediatrics, Makerere University and Mulago Hospital, Kampala, Uganda.'}, {'ForeName': 'Margaret J', 'Initials': 'MJ', 'LastName': 'Thomason', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London.'}, {'ForeName': 'Imelda', 'Initials': 'I', 'LastName': 'Bates', 'Affiliation': 'Liverpool School of Tropical Medicine and Hygiene, Liverpool, UK.'}, {'ForeName': 'Michael Boele', 'Initials': 'MB', 'LastName': 'von Hensbroek', 'Affiliation': ""Emma Children's Hospital, Academic Medical Center, Amsterdam, The Netherlands.""}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Evans', 'Affiliation': 'Department of Paediatrics, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Uyoga', 'Affiliation': 'Kenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Thomas N', 'Initials': 'TN', 'LastName': 'Williams', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK; Kenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Frost', 'Affiliation': 'Nutrition Research Section, Imperial College London, London, UK.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'George', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Gibb', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London.'}, {'ForeName': 'A Sarah', 'Initials': 'AS', 'LastName': 'Walker', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Global health,['10.1016/S2214-109X(19)30345-6']
2020,31047670,"Multi-arm, multi-stage randomised controlled trials for evaluating therapeutic HIV cure interventions.","The evaluation of immune-based approaches to achieve an antiretroviral therapy free remission of HIV infection requires proven efficacy through antiretroviral therapy interruption placebo-controlled trials. This approach is not without risk to participants and innovative trial designs need to be developed that minimise the number of participants treated with placebo and ineffective candidates. Multi-arm, multi-stage (MAMS) trial designs can be used in this context to accelerate the development of an immune-based therapeutic agent for HIV cure. Issues related to implementing a MAMS design within the planned EHVA T01 trial are considered here. EHVA T01 is a multicentre, MAMS, double-blind, phase 1 and 2 trial that aims to evaluate the effect of immune interventions on viral control in HIV-1 infected participants following analytic treatment interruption. The application of a MAMS design increases the likelihood that the EHVA T01 trial will identify a successful treatment and minimises the number of participants undergoing analytical treatment interruptions who have been treated with futile agents. The use of a MAMS design is a promising strategy to evaluate complex immune-based approaches aimed at curing HIV-infection, particularly relevant to the pipeline with multiple agents requiring examination.",2019,This approach is not without risk to participants and innovative trial designs need to be developed that minimise the number of participants treated with placebo and ineffective candidates.,"['HIV-1 infected participants following analytic treatment interruption', 'participants undergoing analytical treatment interruptions who have been treated with futile agents']","['immune interventions', 'placebo']",[],"[{'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.462661,This approach is not without risk to participants and innovative trial designs need to be developed that minimise the number of participants treated with placebo and ineffective candidates.,"[{'ForeName': 'Cecilia L', 'Initials': 'CL', 'LastName': 'Moore', 'Affiliation': 'Medical Research Council Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK. Electronic address: c.moore@ucl.ac.uk.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Stöhr', 'Affiliation': 'Medical Research Council Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Crook', 'Affiliation': 'Medical Research Council Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Richert', 'Affiliation': 'Vaccine Research Institute, Créteil, France; University of Bordeaux, Inserm, Bordeaux Population Health Research Center, Team SISTM, UMR 1219, and Inria, Bordeaux, France; European Clinical Trials Platform and Development, and French Clinical Research Infrastructure Network, CIC 1401, University of Bordeaux, Inserm, CHU Bordeaux, Bordeaux, France.'}, {'ForeName': 'Jean-Daniel', 'Initials': 'JD', 'LastName': 'Leliévre', 'Affiliation': 'Vaccine Research Institute, Créteil, France; INSERM U955, Paris Est Créteil University, Créteil, France.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pantaleo', 'Affiliation': 'Service of Immunology and Allergy, and Swiss Vaccine Research Institute, Lausanne University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'García', 'Affiliation': 'Infectious Diseases Department, Hospital Clinic of Barcelona-HIVACAT, University of Barcelona, Barcelona, Spain; Retrovirology and Viral Immunopathology Laboratory, AIDS Research Group, August Pi i Sunyer Biomedical Research Institute (IDIBAPS)-HIVACAT, Barcelona, Spain.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Vella', 'Affiliation': 'Center for Global Health, Istituto Superiore di Sanità, Rome, Italy.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Lévy', 'Affiliation': ""Vaccine Research Institute, Créteil, France; INSERM U955, Paris Est Créteil University, Créteil, France; AP-HP, Hôpital Henri-Mondor Albert-Chenevier, Service d'Immunologie Clinique et Maladies Infectieuses, Créteil, France.""}, {'ForeName': 'Rodolphe', 'Initials': 'R', 'LastName': 'Thiébaut', 'Affiliation': 'Vaccine Research Institute, Créteil, France; University of Bordeaux, Inserm, Bordeaux Population Health Research Center, Team SISTM, UMR 1219, and Inria, Bordeaux, France; European Clinical Trials Platform and Development, and French Clinical Research Infrastructure Network, CIC 1401, University of Bordeaux, Inserm, CHU Bordeaux, Bordeaux, France.'}, {'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'McCormack', 'Affiliation': 'Medical Research Council Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}]",The lancet. HIV,['10.1016/S2352-3018(19)30082-7']
2021,31152308,Effect of corticosteroids on myocardial injury among patients hospitalized for community-acquired pneumonia: rationale and study design. The colosseum trial.,"Community-acquired pneumonia (CAP) is often complicated by elevation of cardiac troponin, a marker of myocardial injury that can be isolated or associated with myocardial infarction (MI). A retrospective study showed that corticosteroid treatment lowers the incidence of MI during the hospital stay. No data exist so far on the effect of corticosteroids on myocardial injury in CAP patients. The primary objective of the study is to evaluate if methylprednisolone is able to reduce myocardial injury, as assessed by serum high-sensitivity cardiac T Troponin (hs-cTnT), in a cohort of patients hospitalized for CAP. Secondary aims are to evaluate the potential effect of methylprednisolone on cardiovascular events during hospitalization, at 30 days from hospital admission and during 2 years' follow-up. The trial will also examine whether the potential protective effects of methylprednisolone might be due to platelet activation down-regulation. Double-blind randomized placebo-controlled trial. One hundred twenty-two eligible patients will be randomized to a week treatment with iv methylprednisolone (20 mg b.i.d) or placebo from hospital admission. Serum hs-cTnT will be measured at admission and every day until up 3 days from admission. ECG will be monitored every day until discharge. After discharge, all patients will be followed-up 2 years. This is the first clinical trial aimed at examining whether methylprednisolone treatment may reduce myocardial injury. The results of this trial may constitute the basis for conducting a larger multicenter trial aimed to evaluate the effect of corticosteroid on cardiovascular events in this setting.",2020,"Community-acquired pneumonia (CAP) is often complicated by elevation of cardiac troponin, a marker of myocardial injury that can be isolated or associated with myocardial infarction (MI).","['patients hospitalized for CAP', 'One hundred twenty-two eligible patients', 'CAP patients', 'patients hospitalized for community-acquired pneumonia']","['corticosteroid', 'placebo', 'methylprednisolone', 'corticosteroids']","['cardiovascular events', 'myocardial injury', 'incidence of MI during the hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia (disorder)'}]","[{'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",122.0,0.547563,"Community-acquired pneumonia (CAP) is often complicated by elevation of cardiac troponin, a marker of myocardial injury that can be isolated or associated with myocardial infarction (MI).","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Violi', 'Affiliation': 'Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Viale del Policlinico 155, 00161, Rome, Italy. francesco.violi@uniroma1.it.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Calvieri', 'Affiliation': 'Department of Cardiovascular, Respiratory, Nephrologic and Geriatric Sciences, La Sapienza University, Rome, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cangemi', 'Affiliation': 'Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Viale del Policlinico 155, 00161, Rome, Italy.'}]",Internal and emergency medicine,['10.1007/s11739-019-02117-0']
2022,31264800,Mindfulness-based cognitive therapy for children and adolescents with anxiety disorders at-risk for bipolar disorder: A psychoeducation waitlist controlled pilot trial.,"AIM


Previous studies suggest that Mindfulness-Based Cognitive Therapy for Children (MBCT-C) is feasible and may improve anxiety and emotion regulation in youth with anxiety disorders at-risk for bipolar disorder. However, controlled studies are warranted to replicate and extend these findings.
METHODS


In the current study, 24 youth with anxiety disorders who have at least one parent with bipolar disorder participated in a MBCT-C treatment period (n = 24; M age  = 13.6, 75% girls, 79% White) with a subset also participating in a prior psychoeducation waitlist control period (n = 19 M age  = 13.8, 68% girls, 84% White). Participants in both the waitlist and MBCT-C periods completed independently-rated symptom scales at each time point. Participants in the waitlist period received educational materials 12 weeks prior to the beginning of MBCT-C.
RESULTS


There were significantly greater improvements in overall clinical severity in the MBCT-C period compared to the waitlist period, but not in clinician- and child-rated anxiety, emotion regulation or mindfulness. However, increases in mindfulness were associated with improvements in anxiety and emotion regulation in the MBCT-C period, but not the waitlist period.
CONCLUSIONS


Findings suggest that MBCT-C may be effective for improving overall clinical severity in youth with anxiety disorders who are at-risk for bipolar disorder. However, waitlist controlled designs may inflate effect sizes so interpret with caution. Larger studies utilizing prospective randomized controlled designs are warranted.",2020,"However, increases in mindfulness were associated with improvements in anxiety and emotion regulation in the MBCT-C period, but not the waitlist period.
","['youth with anxiety disorders at-risk for bipolar disorder', 'youth with anxiety disorders who are at-risk for bipolar disorder', '24 youth with anxiety disorders who have at least one parent with bipolar disorder participated in a MBCT-C treatment period (n = 24; M age  = 13.6, 75% girls, 79% White) with a subset also participating in a prior psychoeducation waitlist control period (n = 19 M age  = 13.8, 68% girls, 84% White', 'Children (MBCT-C', 'children and adolescents with anxiety disorders at-risk for bipolar disorder']","['Mindfulness-based cognitive therapy', 'MBCT-C', 'Mindfulness-Based Cognitive Therapy']","['clinician- and child-rated anxiety, emotion regulation or mindfulness', 'overall clinical severity', 'anxiety and emotion regulation']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517561', 'cui_str': '13.8 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",24.0,0.0283536,"However, increases in mindfulness were associated with improvements in anxiety and emotion regulation in the MBCT-C period, but not the waitlist period.
","[{'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Cotton', 'Affiliation': 'Department of Family and Community Medicine, Division of Integrative Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Kraemer', 'Affiliation': 'Department of Psychology, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Sears', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Strawn', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Wasson', 'Affiliation': 'Department of Family and Community Medicine, Division of Integrative Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'McCune', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Welge', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Blom', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Durling', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Melissa P', 'Initials': 'MP', 'LastName': 'Delbello', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}]",Early intervention in psychiatry,['10.1111/eip.12848']
2023,32087257,The influence of prolonged temperature management on acute kidney injury after out-of-hospital cardiac arrest: A post hoc analysis of the TTH48 trial.,"BACKGROUND


Acute kidney injury (AKI) is common after cardiac arrest and targeted temperature management (TTM). The impact of different lengths of cooling on the development of AKI has not been well studied. In this study of patients included in a randomised controlled trial of TTM at 33 °C for 24 versus 48 h after cardiac arrest (TTH48 trial), we examined the influence of prolonged TTM on AKI and the incidence and factors associated with the development of AKI. We also examined the impact of AKI on survival.
METHODS


This study was a sub-study of the TTH48 trial, which included patients cooled to 33 ± 1 °C after out-of-hospital cardiac arrest for 24 versus 48 h. AKI was classified according to the KDIGO AKI criteria based on serum creatinine and urine output collected until ICU discharge for a maximum of seven days. Survival was followed for up to six months. The association of admission factors on AKI was analysed with multivariate analysis and the association of AKI on mortality was analysed with Cox regression using the time to AKI as a time-dependent covariate.
RESULTS


Of the 349 patients included in the study, 159 (45.5%) developed AKI. There was no significant difference in the incidence, severity or time to AKI between the 24- and 48-h groups. Serum creatinine values had significantly different trajectories for the two groups with a sharp rise occurring during rewarming. Age, time to return of spontaneous circulation, serum creatinine at admission and body mass index were independent predictors of AKI. Patients with AKI had a higher mortality than patients without AKI (hospital mortality 36.5% vs 12.5%, p < 0.001), but only AKI stages 2 and 3 were independently associated with mortality.
CONCLUSIONS


We did not find any association between prolonged TTM at 33 °C and the risk of AKI during the first seven days in the ICU. AKI is prevalent after cardiac arrest and TTM and occurs in almost half of all ICU admitted patients and more commonly in the elderly, with an increasing BMI and longer arrest duration. AKI after cardiac arrest is an independent predictor of time to death.",2020,"There was no significant difference in the incidence, severity or time to AKI between the 24- and 48-hour groups.","['TTH48 trial, which included patients cooled to 33±1˚C after out-of-hospital cardiac arrest for 24 versus 48hours', '349 patients included in the study, 159 (45.5%) developed AKI', 'acute kidney injury after out-of-hospital cardiac arrest']","['prolonged temperature management', 'TTM']","['higher mortality', 'mortality', 'Serum creatinine values', 'Survival', 'incidence, severity or time to AKI', 'Age, time to return of spontaneous circulation, serum creatinine at admission and body mass index']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",349.0,0.11476,"There was no significant difference in the incidence, severity or time to AKI between the 24- and 48-hour groups.","[{'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Strand', 'Affiliation': 'Department of Intensive Care, Stavanger University Hospital, Norway. Electronic address: kristian.strand@sus.no.'}, {'ForeName': 'Eldar', 'Initials': 'E', 'LastName': 'Søreide', 'Affiliation': 'Critical Care and Anaesthesiology Research Group, Stavanger University Hospital, Stavanger, Norway; Department Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Kirkegaard', 'Affiliation': 'Research Centre for Emergency Medicine and Emergency Department, Aarhus University and Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Fabio Silvio', 'Initials': 'FS', 'LastName': 'Taccone', 'Affiliation': 'Department of Intensive Care, Erasme Hospital, Belgium.'}, {'ForeName': 'Anders Morten', 'Initials': 'AM', 'LastName': 'Grejs', 'Affiliation': 'Department of Intensive Care Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Christophe Henri Valdemar', 'Initials': 'CHV', 'LastName': 'Duez', 'Affiliation': 'Research Centre for Emergency Medicine and Emergency Department, Aarhus University and Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Anni Nørgaard', 'Initials': 'AN', 'LastName': 'Jeppesen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Storm', 'Affiliation': 'Department of Internal Medicine, Nephrology and Intensive Care, Charité-University, Berlin, Germany.'}, {'ForeName': 'Bodil Steen', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Aalborg University Hospital, and Clinical Institute, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Laitio', 'Affiliation': 'Division of Perioperative Services, Intensive Care Medicine and Pain Management, Turku University Hospital and University of Turku, Finland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hassager', 'Affiliation': 'Department of Cardiology, Rigshospitalet and Dept of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Valdo', 'Initials': 'V', 'LastName': 'Toome', 'Affiliation': 'Department of Intensive Cardiac Care, North Estonia Medical Centre, Tallinn, Estonia.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Hästbacka', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Paine Medicine, University of Helsinki and Helsinki University Hospital, Finland.'}, {'ForeName': 'Markus B', 'Initials': 'MB', 'LastName': 'Skrifvars', 'Affiliation': 'Department of Emergency Care and Services, Helsinki University Hospital, Finland.'}]",Resuscitation,['10.1016/j.resuscitation.2020.01.039']
2024,31004139,The Kansas University DHA Outcomes Study (KUDOS) clinical trial: long-term behavioral follow-up of the effects of prenatal DHA supplementation.,"BACKGROUND


Docosahexaenoic acid (DHA) is a long-chain polyunsaturated fatty acid that has been linked to improved vision and cognition in postnatal feeding studies and has been consistently associated with reduction of early preterm birth in prenatal supplementation trials. This is a report of the first long-term follow-up of infants from mothers receiving prenatal DHA supplementation in a US cohort.
OBJECTIVE


Our objective was to evaluate the efficacy of the prenatal supplementation on both global and granular longitudinal assessments of cognitive and behavioral development.
METHODS


In a randomized double-blind clinical trial, mothers received either 600 mg/d of DHA or a placebo beginning at 14.5 weeks of gestation and capsules were provided until delivery. Children from those pregnancies were followed by cognitive and behavioral assessments administered from 10 mo through 6 y of age. From 301 mothers in the initial study, ∼200 infants completed the longitudinal schedule.
RESULTS


Although this intervention had been shown to reduce high-risk pregnancies and improve visual attention in infants during the first year, only a few positive long-term effects of prenatal DHA supplementation emerged from analyses of this follow-up. Increases in maternal blood DHA during pregnancy were related to verbal and full scale intelligence quotient (IQ) scores at 5 and 6 y, but these effects disappeared after controlling for SES. Maternal blood DHA concentrations at delivery were unrelated to outcomes, although maternal DHA at enrollment was related to productive vocabulary at 18 mo.
CONCLUSIONS


Although prenatal DHA supplementation substantially reduced early preterm birth and improved visual attention in infancy in this sample, no consistent long-term benefits were observed into childhood. Increases in maternal blood DHA concentration in pregnancy were related to higher IQs but this effect was confounded with SES and disappeared when SES was statistically controlled. This trial was registered at http://www.clinicaltrials.gov as NCT00266825 and NCT02487771.",2019,Increases in maternal blood DHA concentration in pregnancy were related to higher IQs but this effect was confounded with SES and disappeared when SES was statistically controlled.,"['infants from mothers receiving', '301 mothers in the initial study, ∼200 infants completed the longitudinal schedule']","['prenatal supplementation', 'prenatal DHA supplementation', 'DHA or a placebo', 'Docosahexaenoic acid (DHA']","['early preterm birth and improved visual attention', 'maternal blood DHA concentration', 'verbal and full scale intelligence quotient (IQ) scores', 'high-risk pregnancies', 'visual attention', 'maternal blood DHA', 'Maternal blood DHA concentrations']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0589102', 'cui_str': 'Visual attention, function (observable entity)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0005768'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242786', 'cui_str': 'High-Risk Pregnancy'}]",,0.467493,Increases in maternal blood DHA concentration in pregnancy were related to higher IQs but this effect was confounded with SES and disappeared when SES was statistically controlled.,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Colombo', 'Affiliation': 'Department of Psychology and Schiefelbusch Institute for Life Span Studies, University of Kansas, Lawrence, KS.'}, {'ForeName': 'D Jill', 'Initials': 'DJ', 'LastName': 'Shaddy', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Gustafson', 'Affiliation': 'Hoglund Brain Imaging Center, University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Byron J', 'Initials': 'BJ', 'LastName': 'Gajewski', 'Affiliation': 'Department of Biostatistics, University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Jocelynn M', 'Initials': 'JM', 'LastName': 'Thodosoff', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kerling', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Carlson', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, KS.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqz018']
2025,30395486,"The Combination of Atomoxetine and Oxybutynin Greatly Reduces Obstructive Sleep Apnea Severity. A Randomized, Placebo-controlled, Double-Blind Crossover Trial.","Rationale:  There is currently no effective pharmacological treatment for obstructive sleep apnea (OSA). Recent investigations indicate that drugs with noradrenergic and antimuscarinic effects improve genioglossus muscle activity and upper airway patency during sleep.  Objectives:  We aimed to determine the effects of the combination of a norepinephrine reuptake inhibitor (atomoxetine) and an antimuscarinic (oxybutynin) on OSA severity (apnea-hypopnea index [AHI]; primary outcome) and genioglossus responsiveness (secondary outcome) in people with OSA.  Methods:  A total of 20 people completed a randomized, placebo-controlled, double-blind, crossover trial comparing 1 night of 80 mg atomoxetine plus 5 mg oxybutynin (ato-oxy) to placebo administered before sleep. The AHI and genioglossus muscle responsiveness to negative esophageal pressure swings were measured via in-laboratory polysomnography. In a subgroup of nine patients, the AHI was also measured when the drugs were administered separately.  Measurements and Main Results:  The participants' median (interquartile range) age was 53 (46-58) years and body mass index was 34.8 (30.0-40.2) kg/m 2 . ato-oxy lowered AHI by 63% (34-86%), from 28.5 (10.9-51.6) events/h to 7.5 (2.4-18.6) events/h ( P  < 0.001). Of the 15/20 patients with OSA on placebo (AHI > 10 events/hr), AHI was lowered by 74% (62-88%) ( P  < 0.001) and all 15 patients exhibited a ≥50% reduction. Genioglossus responsiveness increased approximately threefold, from 2.2 (1.1-4.7)%/cm H 2 O on placebo to 6.3 (3.0 to 18.3)%/cm H 2 O on ato-oxy ( P  < 0.001). Neither atomoxetine nor oxybutynin reduced the AHI when administered separately.  Conclusions:  A combination of noradrenergic and antimuscarinic agents administered orally before bedtime on 1 night greatly reduced OSA severity. These findings open new possibilities for the pharmacologic treatment of OSA. Clinical trial registered with www.clinicaltrials.gov (NCT02908529).",2019,"ato-oxy lowered AHI by 63% (34-86%), from 28.5 (10.9-51.6) events/h to 7.5 (2.4-18.6) events/h ( P  < 0.001).","[""participants' median (interquartile range) age was 53 (46-58) years and body mass index was 34.8 (30.0-40.2) kg/m 2 "", '15/20 patients with OSA on', 'obstructive sleep apnea (OSA', '20 people', 'people with OSA']","['Atomoxetine and Oxybutynin', 'norepinephrine reuptake inhibitor (atomoxetine) and an antimuscarinic (oxybutynin', 'placebo', 'Placebo', 'noradrenergic and antimuscarinic agents', 'atomoxetine', 'atomoxetine plus 5 mg oxybutynin']","['OSA severity', 'AHI', 'OSA severity (apnea-hypopnea index [AHI', 'Obstructive Sleep Apnea Severity', 'Genioglossus responsiveness', 'genioglossus muscle activity and upper airway patency']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0076823', 'cui_str': 'atomoxetine'}, {'cui': 'C0069805', 'cui_str': 'oxybutynin'}, {'cui': 'C4521489', 'cui_str': 'Norepinephrine reuptake inhibitor (disposition)'}, {'cui': 'C4521482', 'cui_str': 'Antimuscarinic'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003385', 'cui_str': 'Antimuscarinic Agents'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0224194', 'cui_str': 'Structure of genioglossus muscle'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]",,0.549846,"ato-oxy lowered AHI by 63% (34-86%), from 28.5 (10.9-51.6) events/h to 7.5 (2.4-18.6) events/h ( P  < 0.001).","[{'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Taranto-Montemurro', 'Affiliation': ""1 Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital & Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Ludovico', 'Initials': 'L', 'LastName': 'Messineo', 'Affiliation': ""1 Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital & Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Sands', 'Affiliation': ""1 Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital & Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Azarbarzin', 'Affiliation': ""1 Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital & Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Melania', 'Initials': 'M', 'LastName': 'Marques', 'Affiliation': ""1 Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital & Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Edwards', 'Affiliation': '4 Sleep and Circadian Medicine Laboratory, Department of Physiology, and.'}, {'ForeName': 'Danny J', 'Initials': 'DJ', 'LastName': 'Eckert', 'Affiliation': '6 Neuroscience Research Australia and the University of New South Wales, Randwick, New South Wales, Australia.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'White', 'Affiliation': ""1 Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital & Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wellman', 'Affiliation': ""1 Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital & Harvard Medical School, Boston, Massachusetts.""}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201808-1493OC']
2026,30169436,"Benefits of Methylphenidate for Long-Term Attention Problems After Traumatic Brain Injury in Childhood: A Randomized, Double-Masked, Placebo-Controlled, Dose-Titration, Crossover Trial.","OBJECTIVE


To characterize the benefits and optimal dose of long-acting methylphenidate for management of long-term attention problems after childhood traumatic brain injury (TBI).
DESIGN


Phase 2, randomized, double-masked, placebo-controlled, dose-titration, crossover clinical trial.
SETTING


Outpatient, clinical research.
PARTICIPANTS


Twenty-six children aged 6 to 17 years who were at least 6 months post-TBI and met criteria for attention-deficit hyperactivity disorder (ADHD) at the time of enrollment.
OUTCOME MEASURES


Vanderbilt Rating Scale of attention problems, Pittsburgh Side Effects Rating Scale, and vital signs.
RESULTS


Among the 26 participants randomized, 20 completed the trial. The mean ages at injury and enrollment were 6.3 and 11.5 years, respectively. Eight participants had a severe TBI. On an optimal dose of medication, greater reductions were found on the Vanderbilt Parent Rating Scale for the medicated condition than for placebo (P = .022, effect size = 0.59). The mean optimal dose of methylphenidate was 40.5 mg (1.00 mg/kg/day). Preinjury ADHD diagnosis status was not associated with a differential medication response. Methylphenidate was associated with weight loss (∼1 kg), increased systolic blood pressure (∼3- to 6-point increase), and mild reported changes in appetite.
CONCLUSION


Findings support use of long-acting methylphenidate for management of long-term attention problems after pediatric TBI. Larger trials are warranted of stimulant medications, including comparative effectiveness and combination medication and nonmedication interventions.",2019,"On an optimal dose of medication, greater reductions were found on the Vanderbilt Parent Rating Scale for the medicated condition than for placebo (P = .022, effect size = 0.59).","['Eight participants had a severe TBI', 'Twenty-six children aged 6 to 17 years who were at least 6 months post-TBI and met criteria for attention-deficit hyperactivity disorder (ADHD) at the time of enrollment', '26 participants randomized, 20 completed the trial', 'After Traumatic Brain Injury in Childhood']","['placebo', 'Placebo', 'long-acting methylphenidate', 'Methylphenidate', 'methylphenidate']","['weight loss', 'Vanderbilt Parent Rating Scale', 'Vanderbilt Rating Scale of attention problems, Pittsburgh Side Effects Rating Scale, and vital signs', 'systolic blood pressure', 'appetite']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0222045'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0518766'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}]",26.0,0.688528,"On an optimal dose of medication, greater reductions were found on the Vanderbilt Parent Rating Scale for the medicated condition than for placebo (P = .022, effect size = 0.59).","[{'ForeName': 'Brad G', 'Initials': 'BG', 'LastName': 'Kurowski', 'Affiliation': ""Division of Physical Medicine and Rehabilitation (Drs Kurowski, Pruitt, and Wade), Division of Behavioral Medicine and Clinical Psychology (Dr Epstein), Division of Neurology (Dr Horn), and Division of Biostatistics and Epidemiology (Dr Altaye), Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; and Departments of Pediatrics and Neurology and Rehabilitation Medicine (Drs Kurowski and Pruitt) and Department of Pediatrics (Drs Epstein, Horn, Altaye, and Wade), University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'Jeffery N', 'Initials': 'JN', 'LastName': 'Epstein', 'Affiliation': ''}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Pruitt', 'Affiliation': ''}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Horn', 'Affiliation': ''}, {'ForeName': 'Mekibib', 'Initials': 'M', 'LastName': 'Altaye', 'Affiliation': ''}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Wade', 'Affiliation': ''}]",The Journal of head trauma rehabilitation,['10.1097/HTR.0000000000000432']
2027,30554749,"Independent and combined effects of improved water, sanitation, and hygiene, and improved complementary feeding, on child stunting and anaemia in rural Zimbabwe: a cluster-randomised trial.","BACKGROUND


Child stunting reduces survival and impairs neurodevelopment. We tested the independent and combined effects of improved water, sanitation, and hygiene (WASH), and improved infant and young child feeding (IYCF) on stunting and anaemia in in Zimbabwe.
METHODS


We did a cluster-randomised, community-based, 2 × 2 factorial trial in two rural districts in Zimbabwe. Clusters were defined as the catchment area of between one and four village health workers employed by the Zimbabwe Ministry of Health and Child Care. Women were eligible for inclusion if they permanently lived in clusters and were confirmed pregnant. Clusters were randomly assigned (1:1:1:1) to standard of care (52 clusters), IYCF (20 g of a small-quantity lipid-based nutrient supplement per day from age 6 to 18 months plus complementary feeding counselling; 53 clusters), WASH (construction of a ventilated improved pit latrine, provision of two handwashing stations, liquid soap, chlorine, and play space plus hygiene counselling; 53 clusters), or IYCF plus WASH (53 clusters). A constrained randomisation technique was used to achieve balance across the groups for 14 variables related to geography, demography, water access, and community-level sanitation coverage. Masking of participants and fieldworkers was not possible. The primary outcomes were infant length-for-age Z score and haemoglobin concentrations at 18 months of age among children born to mothers who were HIV negative during pregnancy. These outcomes were analysed in the intention-to-treat population. We estimated the effects of the interventions by comparing the two IYCF groups with the two non-IYCF groups and the two WASH groups with the two non-WASH groups, except for outcomes that had an important statistical interaction between the interventions. This trial is registered with ClinicalTrials.gov, number NCT01824940.
FINDINGS


Between Nov 22, 2012, and March 27, 2015, 5280 pregnant women were enrolled from 211 clusters. 3686 children born to HIV-negative mothers were assessed at age 18 months (884 in the standard of care group from 52 clusters, 893 in the IYCF group from 53 clusters, 918 in the WASH group from 53 clusters, and 991 in the IYCF plus WASH group from 51 clusters). In the IYCF intervention groups, the mean length-for-age Z score was 0·16 (95% CI 0·08-0·23) higher and the mean haemoglobin concentration was 2·03 g/L (1·28-2·79) higher than those in the non-IYCF intervention groups. The IYCF intervention reduced the number of stunted children from 620 (35%) of 1792 to 514 (27%) of 1879, and the number of children with anaemia from 245 (13·9%) of 1759 to 193 (10·5%) of 1845. The WASH intervention had no effect on either primary outcome. Neither intervention reduced the prevalence of diarrhoea at 12 or 18 months. No trial-related serious adverse events, and only three trial-related adverse events, were reported.
INTERPRETATION


Household-level elementary WASH interventions implemented in rural areas in low-income countries are unlikely to reduce stunting or anaemia and might not reduce diarrhoea. Implementation of these WASH interventions in combination with IYCF interventions is unlikely to reduce stunting or anaemia more than implementation of IYCF alone.
FUNDING


Bill & Melinda Gates Foundation, UK Department for International Development, Wellcome Trust, Swiss Development Cooperation, UNICEF, and US National Institutes of Health.",2019,"The IYCF intervention reduced the number of stunted children from 620 (35%) of 1792 to 514 (27%) of 1879, and the number of children with anaemia from 245 (13·9%) of 1759 to 193 (10·5%) of 1845.","['two rural districts in Zimbabwe', 'child stunting and anaemia in rural Zimbabwe', '3686 children born to HIV-negative mothers were assessed at age 18 months (884 in the standard of care group from 52 clusters, 893 in the IYCF group from 53 clusters, 918 in the WASH group from 53 clusters, and 991 in the', 'Women were eligible for inclusion if they permanently lived in clusters and were confirmed pregnant', 'infant and young child feeding (IYCF) on stunting and anaemia in in Zimbabwe', 'Between Nov 22, 2012, and March 27, 2015, 5280 pregnant women were enrolled from 211 clusters']","['WASH intervention', 'IYCF plus WASH', 'IYCF (20 g of a small-quantity lipid-based nutrient supplement per day from age 6 to 18 months plus complementary feeding counselling; 53 clusters), WASH (construction of a ventilated improved pit latrine, provision of two handwashing stations, liquid soap, chlorine, and play space plus hygiene counselling; 53 clusters), or IYCF plus WASH', 'IYCF interventions', 'improved water, sanitation, and hygiene (WASH', 'IYCF intervention']","['prevalence of diarrhoea', 'mean length-for-age Z score', 'mean haemoglobin concentration', 'infant length-for-age Z score and haemoglobin concentrations', 'number of stunted children', 'improved water, sanitation, and hygiene, and improved complementary feeding', 'stunting or anaemia']","[{'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1547959', 'cui_str': 'Wash - dosing instruction imperative'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C1547959', 'cui_str': 'Wash - dosing instruction imperative'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0450403', 'cui_str': '20G (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0038847', 'cui_str': 'Complementary Feeding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0441513', 'cui_str': 'Construction (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C3266595', 'cui_str': 'Pit latrine'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0008209', 'cui_str': 'Chlorine'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0455806', 'cui_str': 'Infant length (observable entity)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0038847', 'cui_str': 'Complementary Feeding'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",5280.0,0.147832,"The IYCF intervention reduced the number of stunted children from 620 (35%) of 1792 to 514 (27%) of 1879, and the number of children with anaemia from 245 (13·9%) of 1759 to 193 (10·5%) of 1845.","[{'ForeName': 'Jean H', 'Initials': 'JH', 'LastName': 'Humphrey', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore MD, USA; Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe. Electronic address: jhumphrey@zvitambo.co.zw.'}, {'ForeName': 'Mduduzi N N', 'Initials': 'MNN', 'LastName': 'Mbuya', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore MD, USA; Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe; Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA; Global Alliance for Improved Nutrition, Washington, DC, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ntozini', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Moulton', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore MD, USA.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Stoltzfus', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Naume V', 'Initials': 'NV', 'LastName': 'Tavengwa', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Kuda', 'Initials': 'K', 'LastName': 'Mutasa', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Majo', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Batsirai', 'Initials': 'B', 'LastName': 'Mutasa', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Goldberg', 'Initials': 'G', 'LastName': 'Mangwadu', 'Affiliation': 'Ministry of Health and Child Care, Harare, Zimbabwe.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Chasokela', 'Affiliation': 'Ministry of Health and Child Care, Harare, Zimbabwe.'}, {'ForeName': 'Ancikaria', 'Initials': 'A', 'LastName': 'Chigumira', 'Affiliation': 'Ministry of Health and Child Care, Harare, Zimbabwe.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chasekwa', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Smith', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe; Department of Epidemiology and Environmental Health, School of Public Health and Health Professions, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Tielsch', 'Affiliation': 'Department of Global Health, Milken Institute School of Public Health, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Jones', 'Affiliation': 'Department of Nutritional Sciences, School of Public Health, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Amee R', 'Initials': 'AR', 'LastName': 'Manges', 'Affiliation': 'University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Maluccio', 'Affiliation': 'Middlebury College, Middlebury, VT, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Prendergast', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore MD, USA; Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe; Blizard Institute, Queen Mary University of London, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Global health,['10.1016/S2214-109X(18)30374-7']
2028,30332312,Stigma Diminishes the Protective Effect of Social Support on Psychological Distress Among Young Black Men Who Have Sex With Men.,"Addressing stigma remains a pressing HIV priority globally. Young Black men who have sex with men (YBMSM, ages 18-30; N = 474) completed an in-person baseline survey and reported their experiences of externalized stigma (i.e., racial and sexuality discrimination), internalized stigma (i.e., homonegativity), social support, and psychological distress (i.e., anxiety and depression symptoms). We used structural equation modeling to test the association between stigma and psychological distress, and examined whether social support mediated the relationship between stigma and psychological distress. Recognizing that these associations may differ by HIV status, we compared our models by self-reported HIV status (n = 275 HIV negative/unknown; n = 199 living with HIV). Our findings suggest that YBMSM who experience stigma are more vulnerable to psychological distress and may have diminished buffering through social support. These effects are accentuated among YBMSM living with HIV, highlighting the need for additional research focused on the development of tailored stigma reduction interventions for YBMSM.",2018,Our findings suggest that YBMSM who experience stigma are more vulnerable to psychological distress and may have diminished buffering through social support.,"['Who Have Sex With Men', 'Young Black Men', 'Young Black men who have sex with men (YBMSM, ages 18-30; N = 474) completed an in-person baseline survey and reported their experiences of externalized stigma (i.e., racial and sexuality discrimination), internalized stigma (i.e., homonegativity), social support, and psychological distress (i.e., anxiety and depression symptoms']",['Social Support'],['Psychological Distress'],"[{'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0037438'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[{'cui': 'C0037438'}],"[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",275.0,0.0196779,Our findings suggest that YBMSM who experience stigma are more vulnerable to psychological distress and may have diminished buffering through social support.,"[{'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Bauermeister', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Muessig', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Dalmacio D', 'Initials': 'DD', 'LastName': 'Flores', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'LeGrand', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Seulki', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Willa', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': ''}, {'ForeName': 'Gary W', 'Initials': 'GW', 'LastName': 'Harper', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Lisa B', 'Initials': 'LB', 'LastName': 'Hightow-Weidman', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina.'}]",AIDS education and prevention : official publication of the International Society for AIDS Education,['10.1521/aeap.2018.30.5.406']
2029,31381365,Competency-Based Approaches to Community Health: A Randomized Controlled Trial to Reduce Childhood Obesity among Latino Preschool-Aged Children.,"Background:  Health behavior change interventions that target childhood obesity in minority populations have led to inconsistent and short-lived results. The purpose of this study was to test a novel intervention that was personalized and family-based in a Latino population to reduce childhood obesity.  Methods:  Competency-Based Approaches to Community Health (COACH) was a randomized controlled trial. Latino parent - child pairs were recruited from community settings in Nashville, TN. Child eligibility criteria included age 3-5 years and a BMI ≥50th percentile. The intervention included 15 weekly, 90-minute sessions followed by 3 months of twice-monthly health coaching calls. The control group was a twice-monthly school readiness curriculum for 3 months. Sessions were conducted by a health coach in local community centers, with groups of 8-11 parent - child pairs. The primary outcome was child BMI trajectory across 12 months, measured at four times. The intervention's effect was assessed by using a longitudinal, linear mixed-effects growth model, adjusting for child gender, baseline child and parent age, and baseline parent BMI and education.  Results:  Of the 305 parent - child pairs assessed for eligibility, 117 were randomized (59 intervention, 58 control). Child BMI was available for 91.5% at 1-year follow-up. Mean baseline child age was 4.2 [standard deviation (SD) = 0.8] years, and 53.8% of children were female. Mean baseline child BMI was 18.1 (SD = 2.6) kg/m 2 . After adjusting for covariates, the intervention's effect on linear child BMI growth was -0.41 kg/m 2  per year (95% confidence interval -0.82 to 0.01;  p  = 0.05).  Conclusions:  Over 1-year follow-up, the intervention resulted in slower linear BMI growth for Latino preschool-aged children from poverty.",2019,"After adjusting for covariates, the intervention's effect on linear child BMI growth was -0.41 kg/m 2  per year (95% confidence interval -0.82 to 0.01;  p  = 0.05).  ","['305 parent - child pairs assessed for eligibility, 117 were randomized (59 intervention, 58 control', 'Latino parent - child pairs were recruited from community settings in Nashville, TN', 'Latino Preschool-Aged Children', 'Latino preschool-aged children from poverty', 'Child eligibility criteria included age 3-5 years and a BMI ≥50th percentile', 'Community Health', 'Mean baseline child age was 4.2 [standard deviation (SD)\u2009=\u20090.8] years, and 53.8% of children were female']",['Methods:  Competency-Based Approaches to Community Health (COACH'],"['child BMI trajectory', 'slower linear BMI growth', 'Child BMI', 'Childhood Obesity', 'linear child BMI growth', 'Mean baseline child BMI']","[{'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C2362324', 'cui_str': 'Childhood Onset Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",117.0,0.0917583,"After adjusting for covariates, the intervention's effect on linear child BMI growth was -0.41 kg/m 2  per year (95% confidence interval -0.82 to 0.01;  p  = 0.05).  ","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Heerman', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Teeters', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado Boulder, Boulder, CO.'}, {'ForeName': 'Evan C', 'Initials': 'EC', 'LastName': 'Sommer', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Burgess', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Escarfuller', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Van Wyk', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Barkin', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Ashley A', 'Initials': 'AA', 'LastName': 'Duhon', 'Affiliation': 'School of Medicine, Louisiana State University Health Sciences Center New Orleans, New Orleans, LA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Cole', 'Affiliation': 'Jacobs School of Medicine and Biomedical Sciences, SUNY at Buffalo, Buffalo, NY.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Samuels', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Marcy', 'Initials': 'M', 'LastName': 'Singer-Gabella', 'Affiliation': 'Department of Teaching and Learning, Vanderbilt University, Nashville, TN.'}]",Childhood obesity (Print),['10.1089/chi.2019.0064']
2030,31034106,Differences in long-term physical activity trajectories among individuals with chronic widespread pain: A secondary analysis of a randomized controlled trial.,"BACKGROUND


Little is known about long-term physical activity (PA) maintenance in those with chronic widespread pain (CWP) following an exercise intervention. This study examined PA over time to identify the existence and characteristics of subgroups following distinct PA trajectories.
METHODS


Data come from individuals with CWP who took part in a 2 × 2 factorial randomized controlled trial, receiving either exercise or both exercise and cognitive behavioural therapy treatment. Information, including self-report PA, was collected at baseline recruitment, immediately post-intervention, 3, 24 and 60+ month post-treatment. Analyses were conducted on 196 men and women with ≥ 3 PA data points. Group-based trajectory modelling was used to identify latent PA trajectory groups and baseline characteristics (e.g., demographics, pain, self-rated health, fatigue, coping-strategy use and kinesiophobia) of these groups.
RESULTS


The best fitting model identified was one with three trajectories: ""non-engagers"" (n = 32), ""maintainers"" (n = 144) and ""super-maintainers"" (n = 20). Overall, mean baseline PA levels were significantly different between groups (non-engagers: 1.1; maintainers: 4.6; super-maintainers: 8.6, p < 0.001) and all other follow-up points. Non-engagers reported, on average, greater BMI, higher disabling chronic pain, poorer self-rated health, physical functioning, as well as greater use of passive coping strategies and lower use of active coping strategies.
CONCLUSIONS


The majority of individuals with CWP receiving exercise as part of a trial were identified as long-term PA maintainers. Participants with poorer physical health and coping response to symptoms were identified as non-engagers. For optimal symptom management, a stratified approach may enhance initiation and long-term PA maintenance in individuals with CWP.
SIGNIFICANCE


Chronic pain can be a major barrier to engaging in exercise, a popular self-management strategy. Our findings identify three distinct long-term physical activity trajectories for individuals receiving the same exercise intervention. This suggests an approach by health care providers which identifies individuals who would benefit from additional support to enhance initiation and long-term physical activity maintenance could deliver better outcomes for such patients.",2019,"Overall, mean baseline PA levels were significantly different between groups (non-engagers: 1.1; maintainers: 4.6; super-maintainers: 8.6, p < 0.001) and all other follow-up points.","['individuals with chronic widespread pain', 'individuals with CWP', 'Data come from individuals with CWP who took part in a 2\xa0×\xa02 factorial randomized controlled trial, receiving either', 'Participants with poorer physical health and coping response to symptoms were identified as non-engagers', '196 men and women with\xa0≥\xa03 PA data points']",['exercise or both exercise and cognitive behavioural therapy treatment'],"['BMI, higher disabling chronic pain, poorer self-rated health, physical functioning', 'mean baseline PA levels']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205391', 'cui_str': 'Widespread (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1565416', 'cui_str': '3-(MTN)PA'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",196.0,0.0921661,"Overall, mean baseline PA levels were significantly different between groups (non-engagers: 1.1; maintainers: 4.6; super-maintainers: 8.6, p < 0.001) and all other follow-up points.","[{'ForeName': 'Kathryn R', 'Initials': 'KR', 'LastName': 'Martin', 'Affiliation': 'Epidemiology Group, Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Druce', 'Affiliation': 'Arthritis Research UK Centre for Epidemiology, Division of Musculoskeletal & Dermatological Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Murdoch', 'Affiliation': 'Epidemiology Group, Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': ""D'Ambruoso"", 'Affiliation': 'Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Macfarlane', 'Affiliation': 'Epidemiology Group, Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, United Kingdom.'}]","European journal of pain (London, England)",['10.1002/ejp.1410']
2031,31530577,Effect of Canagliflozin on Renal and Cardiovascular Outcomes across Different Levels of Albuminuria: Data from the CANVAS Program.,"BACKGROUND


If SGLT2 inhibitors protect the kidneys by reducing albuminuria as hypothesized, people with type 2 diabetes mellitus (T2DM) with higher albuminuria should benefit more.
METHODS


We conducted a  post-hoc  analysis of data from the CANagliflozin cardioVascular Assessment Study (CANVAS) Program, which randomized 10,142 participants with T2DM and high cardiovascular risk to canagliflozin or placebo. We assessed effects of canagliflozin on renal, cardiovascular, and safety outcomes by baseline albuminuria. The trial included 2266 participants (22.3%) with moderately increased albuminuria (urinary albumin/creatinine ratio [UACR] 30-300 mg/g) and 760 (7.5%) with severely increased albuminuria (UACR >300 mg/g) at baseline.
RESULTS


Canagliflozin lowered albuminuria with greater proportional reductions in those with moderately and severely increased albuminuria ( P  heterogeneity<0.001). After week 13, canagliflozin slowed the annual loss of kidney function across albuminuria subgroups, with greater absolute reductions in participants with severely increased albuminuria (placebo-subtracted difference 3.01 ml/min per 1.73 m 2  per year;  P  heterogeneity<0.001). Heterogeneity for the renal composite outcome of 40% reduction in eGFR, ESKD, or renal-related death was driven by lesser effects in participants with moderately increased albuminuria ( P  heterogeneity=0.03), but no effect modification was observed when albuminuria was fitted as a continuous variable ( P  heterogeneity=0.94). Cardiovascular and safety outcomes were mostly consistent across albuminuria levels including increased risks for amputation across albuminuria subgroups ( P  heterogeneity=0.66). Greater absolute risk reductions in the renal composite outcome were observed in participants with severely increased albuminuria ( P  heterogeneity=0.004).
CONCLUSIONS


The proportional effects of canagliflozin on renal and cardiovascular outcomes are mostly consistent across patients with different levels of albuminuria, but absolute benefits are greatest among those with severely increased albuminuria.",2019,Cardiovascular and safety outcomes were mostly consistent across albuminuria levels including increased risks for amputation across albuminuria subgroups ( P  heterogeneity=0.66).,"['2266 participants (22.3%) with moderately increased albuminuria (urinary albumin/creatinine ratio [UACR] 30-300 mg/g) and 760 (7.5%) with severely increased albuminuria (UACR >300 mg/g) at baseline', '10,142 participants with T2DM and high cardiovascular risk to']","['canagliflozin or placebo', 'canagliflozin', 'Canagliflozin']","['eGFR, ESKD, or renal-related death', 'annual loss of kidney function', 'renal, cardiovascular, and safety outcomes', 'Renal and Cardiovascular Outcomes']","[{'cui': 'C0730345', 'cui_str': 'Microalbuminuria (finding)'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",2266.0,0.360591,Cardiovascular and safety outcomes were mostly consistent across albuminuria levels including increased risks for amputation across albuminuria subgroups ( P  heterogeneity=0.66).,"[{'ForeName': 'Brendon L', 'Initials': 'BL', 'LastName': 'Neuen', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Ohkuma', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Matthews', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, Harris Manchester College, University of Oxford, Oxford, UK.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'de Zeeuw', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Department of Medicine, Stanford Center for Clinical Research, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Fulcher', 'Affiliation': 'Royal North Shore Hospital, Sydney, Australia; and.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Jardine', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Oh', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'Hiddo L', 'Initials': 'HL', 'LastName': 'Heerspink', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia; vperkovic@georgeinstitute.org.au.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2019010064']
2032,30952565,"Integrated HIV testing, prevention, and treatment intervention for key populations in India: a cluster-randomised trial.","BACKGROUND


To achieve reductions in HIV incidence, we need strategies to engage key population at risk for HIV in low-income and middle-income countries. We evaluated the effectiveness of integrated care centres in India that provided single-venue HIV testing, prevention, and treatment services for people who inject drugs (PWID) and men who have sex with men (MSM).
METHODS


We did baseline respondent-driven sampling surveys in 27 sites across India, and selected 22 of these (12 PWID and ten MSM) for a cluster randomised trial on the basis of high HIV prevalence and logistical considerations. We used stratified (by PWID and MSM), restricted randomisation to allocate sites to either the integrated care intervention or usual care (11 sites per group). We implemented integrated care centres in 11 cities (six PWID integrated care centres embedded within opioid agonist treatment centres and five MSM centres within government-sponsored health services), with a single integrated care centre per city in all but one city. After a 2-year intervention phase, we did respondent-driven sampling evaluation surveys of target population members who were aged 18 years or older at all sites. The primary outcome was self-reported HIV testing in the previous 12 months (recent testing), determined via the evaluation survey. We used a biometric identification system to estimate integrated care centre exposure (visited an integrated care centre at least once) among evaluation survey participants at intervention sites. This trial is registered with ClinicalTrials.gov, number NCT01686750.
FINDINGS


Between Oct 1, 2012, and Dec 19, 2013, we recruited 11 993 PWID and 9997 MSM in the baseline survey and, between Aug, 1 2016, and May 27, 2017, surveyed 11 721 PWID and 10 005 MSM in the evaluation survey using respondent-driven sampling, across the 22 trial sites. During the intervention phase, integrated care centres provided HIV testing for 14 698 unique clients (7630 PWID and 7068 MSM. In the primary population-level analysis, recent HIV testing was 31% higher at integrated care centres than at usual care sites (adjusted prevalence ratio [PR] 1·31, 95% CI 0·95-1·81, p=0·09). Among survey participants at intervention sites, integrated care centre exposure was lower than expected (median exposure 40% at PWID sites and 24% at MSM sites). In intervention sites, survey participants who visited an integrated care centre were more likely to report recent HIV testing than were participants who had not (adjusted PR 3·46, 2·94-4·06).
INTERPRETATION


Although integrated care centres increased HIV testing among visitors, our low exposure findings suggest that the scale-up of a single integrated care centre in most cities was insufficient to serve the large PWID and MSM populations. Future work should address the use of population size estimates to guide the dose of combination HIV interventions targeting key populations.
FUNDING


US National Institutes of Health and the Elton John AIDS Foundation.",2019,"In the primary population-level analysis, recent HIV testing was 31% higher at integrated care centres than at usual care sites (adjusted prevalence ratio [PR] 1·31, 95% CI 0·95-1·81, p=0·09).","['11 cities (six PWID integrated care centres embedded within opioid agonist treatment centres and five MSM centres within government-sponsored health services), with a single integrated care centre per city in all but one city', 'people who inject drugs (PWID) and men who have sex with men (MSM', 'survey participants who visited an integrated care centre were more likely to report recent HIV testing than were participants who had not (adjusted PR 3·46, 2·94-4·06', 'population members who were aged 18 years or older at all sites', 'Between Oct 1, 2012, and Dec 19, 2013, we recruited 11\u2008993 PWID and 9997 MSM in the baseline survey and, between Aug, 1 2016, and May 27, 2017, surveyed 11\u2008721 PWID and 10\u2008005']",['MSM'],['self-reported HIV testing'],"[{'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]",[],"[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",,0.0710011,"In the primary population-level analysis, recent HIV testing was 31% higher at integrated care centres than at usual care sites (adjusted prevalence ratio [PR] 1·31, 95% CI 0·95-1·81, p=0·09).","[{'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Solomon', 'Affiliation': 'Department of Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA; YR Gaitonde Centre for AIDS Research and Education (YRGCARE), Chennai, India.'}, {'ForeName': 'Suniti', 'Initials': 'S', 'LastName': 'Solomon', 'Affiliation': 'YR Gaitonde Centre for AIDS Research and Education (YRGCARE), Chennai, India.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'McFall', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Aylur K', 'Initials': 'AK', 'LastName': 'Srikrishnan', 'Affiliation': 'YR Gaitonde Centre for AIDS Research and Education (YRGCARE), Chennai, India.'}, {'ForeName': 'Santhanam', 'Initials': 'S', 'LastName': 'Anand', 'Affiliation': 'YR Gaitonde Centre for AIDS Research and Education (YRGCARE), Chennai, India.'}, {'ForeName': 'Vinita', 'Initials': 'V', 'LastName': 'Verma', 'Affiliation': 'National AIDS Control Organisation, Ministry of Health and Family Welfare, New Delhi, India.'}, {'ForeName': 'Canjeevaram K', 'Initials': 'CK', 'LastName': 'Vasudevan', 'Affiliation': 'YR Gaitonde Centre for AIDS Research and Education (YRGCARE), Chennai, India.'}, {'ForeName': 'Pachamuthu', 'Initials': 'P', 'LastName': 'Balakrishnan', 'Affiliation': 'YR Gaitonde Centre for AIDS Research and Education (YRGCARE), Chennai, India.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Ogburn', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Moulton', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Muniratnam S', 'Initials': 'MS', 'LastName': 'Kumar', 'Affiliation': 'YR Gaitonde Centre for AIDS Research and Education (YRGCARE), Chennai, India.'}, {'ForeName': 'Kuldeep Singh', 'Initials': 'KS', 'LastName': 'Sachdeva', 'Affiliation': 'National AIDS Control Organisation, Ministry of Health and Family Welfare, New Delhi, India; Revised National Tuberculosis Control Programme, Ministry of Health and Family Welfare, New Delhi, India.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Laeyendecker', 'Affiliation': 'Department of Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Celentano', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Lucas', 'Affiliation': 'Department of Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA. Electronic address: glucas@jhmi.edu.'}, {'ForeName': 'Shruti H', 'Initials': 'SH', 'LastName': 'Mehta', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(19)30034-7']
2033,31425658,The Tinnitus Retraining Therapy Trial's Standard of Care Control Condition: Rationale and Description of a Patient-Centered Protocol.,"Purpose The selection and design of control conditions are critical factors in minimizing the influence of unwanted variables in randomized controlled trials (RCTs). This article describes the rationale, design, and content of a standard of care control condition in a Phase III RCT of tinnitus retraining therapy. Method Existing tinnitus practices at military hospitals were identified and aligned with the American Speech-Language-Hearing Association's (2006) preferred practice patterns for tinnitus management and counseling and embedded in a patient-centered protocol to ensure uniformity and treatment fidelity. Results For those involved in the design of behavioral RCTs, the article identifies options and methods to consider in the selection and design of control conditions. Conclusion For those who provide tinnitus services, the standard of care protocol developed for the tinnitus retraining therapy trial constitutes a patient-centered approach to intervention that can be implemented clinically. Supplemental Material https://doi.org/10.23641/asha.9342503.",2019,"Conclusion For those who provide tinnitus services, the standard of care protocol developed for the tinnitus retraining therapy trial constitutes a patient-centered approach to intervention that can be implemented clinically.",[],['tinnitus retraining therapy'],[],[],"[{'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.0535409,"Conclusion For those who provide tinnitus services, the standard of care protocol developed for the tinnitus retraining therapy trial constitutes a patient-centered approach to intervention that can be implemented clinically.","[{'ForeName': 'Sue Ann', 'Initials': 'SA', 'LastName': 'Erdman', 'Affiliation': 'Audiologic Rehabilitation Consulting Services, Jensen Beach, FL.'}, {'ForeName': 'Roberta W', 'Initials': 'RW', 'LastName': 'Scherer', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Benigno', 'Initials': 'B', 'LastName': 'Sierra-Irizarry', 'Affiliation': 'Wilford Hall Ambulatory Surgical Center, Lackland AFB, TX.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Formby', 'Affiliation': 'Department of Communicative Disorders, University of Alabama, Tuscaloosa.'}]",American journal of audiology,['10.1044/2019_AJA-18-0068']
2034,29939827,The effects of a relaxation program featuring aquatic therapy and autogenic training among people with cervical dystonia (a pilot study).,"Classic physical interventions for cervical dystonia (CD) have focused on treating motor components or, on motor components and relaxation programs. However, no CD treatment study has focused on a relaxation program alone. We developed a pilot study to assess whether a therapy completely based on a relaxation program could improve the physical and mental symptomatologies of patients with CD. Fifteen persons were included in the experimental group, which received individual sessions of aquatic (Watsu) therapy (WT) and autogenic training (AT). In addition, 12 persons were included in passive control group. We administered different questionnaires related to quality of life (SF-36), pain (Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and Visual Analog Scale (VAS)) and mood (Beck Depression Inventory (BDI-II) and State-Trait Anxiety Inventory (STAI)). A significant interaction was observed between treatment and time with regard to the SF-36, VAS, and TWSTRS within the experimental group ( p  < 0.01). The BDI-II showed depression decrease as a simple effect ( p  < 0.05), and the STAI did not change. No effects were found with regard to the control group. In this exploratory study, we found that a therapy based on whole body relaxation improved the symptoms of patients with CD. This knowledge enables a disease-management strategy that uses a holistic perspective and moves beyond the dystonic focus.",2020,"A significant interaction was observed between treatment and time with regard to the SF-36, VAS, and TWSTRS within the experimental group (p < 0.01).","['Fifteen persons', 'patients with CD', '12 persons were included in passive control group', 'people with cervical dystonia (a pilot study', 'cervical dystonia (CD']","['relaxation program featuring aquatic therapy and autogenic training', 'individual sessions of aquatic (Watsu) therapy (WT) and autogenic training (AT', 'Classic physical interventions']","['physical and mental symptomatologies', 'quality of life (SF-36), pain (Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and Visual Analog Scale (VAS)) and mood (Beck Depression Inventory (BDI-II) and State-Trait Anxiety Inventory (STAI']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0949445', 'cui_str': 'Cervical Dystonia'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}]","[{'cui': 'C0475668', 'cui_str': 'Relaxation program (regime/therapy)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0004361', 'cui_str': 'Progressive Relaxation'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",15.0,0.0127241,"A significant interaction was observed between treatment and time with regard to the SF-36, VAS, and TWSTRS within the experimental group (p < 0.01).","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Isabel Useros-Olmo', 'Affiliation': 'Department of Physiotherapy, Motion in Brains Research Group, Instituto de Neurociencias y Ciencias del Movimiento, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Martínez-Pernía', 'Affiliation': 'Center for Social and Cognitive Neuroscience(CSCN), School of Psychology, Universidad Adolfo Ibáñez, Santiago, Chile.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Huepe', 'Affiliation': 'Center for Social and Cognitive Neuroscience(CSCN), School of Psychology, Universidad Adolfo Ibáñez, Santiago, Chile.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1488319']
2035,31575823,Deep Friction Massage in the Management of Patellar Tendinopathy in Athletes: Short-Term Clinical Outcomes.,"CONTEXT


Deep friction massage (DFM) is often used in the treatment of tendinopathies; however, the pressure applied may vary and interfere with the obtained results.
OBJECTIVE


To assess whether the immediate effects of DFM on pain (pain intensity and time to onset of analgesia) and muscle strength are dependent on the pressure applied during the DFM application in athletes with patellar tendinopathy.
DESIGN


Randomized, controlled, cross-over trial.
SETTING


University research laboratory (institutional).
PARTICIPANTS


Ten athletes with diagnosis of unilateral patellar tendinopathy (age 27.90 [5.24] y).
INTERVENTIONS


All participants attended 4 sessions, 3 treatment sessions with DFM applied with different pressures (the mean pressure-previously determined for each participant-and the mean pressure ± 25%) and a control session, each of which was separated by 48 hours.
MAIN OUTCOME MEASURES


Pain (intensity upon palpation and time to onset of analgesia), and muscle strength of knee extensors were assessed before and immediately after each session.
RESULTS


Pain intensity changed significantly over time (F1,9 = 52.364; P < .001; ηp2=.853) and among sessions (F3,27 = 82.588; P < .001; ηp2=.902), with a significant interaction for group × time (F3,27 = 19.841; P < .001; ηp2=.688). The knee extensors strength did not change significantly over time (F1,9 = 2.240; P = .17; ηp2=.199), nor a significant interaction for session × time was observed (F3,27 = 3.276; P = .07; ηp2=.267). Regardless of the pressure applied, the time to onset of analgesia was not significantly different (F2,18 = 1.026; P > .05; ηp2=.102).
CONCLUSION


It was shown that DFM induces an immediate reduction in pain intensity upon palpation, regardless of the pressure performed. Notwithstanding, the reader should take into account the small sample size and the caution needed in the results' interpretation.",2019,"RESULTS


Pain intensity changed significantly over time (F1,9 = 52.364; P < .001; ηp2=.853) and among sessions (F3,27 = 82.588; P < .001; ηp2=.902), with a significant interaction for group × time (F3,27 = 19.841; P < .001; ηp2=.688).","['athletes with patellar tendinopathy', 'Patellar Tendinopathy in Athletes', 'University research laboratory (institutional', 'Ten athletes with diagnosis of unilateral patellar tendinopathy (age 27.90 [5.24]\xa0y']","['Deep Friction Massage', 'Deep friction massage (DFM', 'DFM']","['knee extensors strength', 'Pain intensity', 'pain (pain intensity and time to onset of analgesia) and muscle strength', 'Pain (intensity upon palpation and time to onset of analgesia), and muscle strength of knee extensors', 'time to onset of analgesia']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C1568272', 'cui_str': 'Tendinopathy'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0035168'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0556839', 'cui_str': 'Physiotherapeutic frictions'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}]",,0.0612652,"RESULTS


Pain intensity changed significantly over time (F1,9 = 52.364; P < .001; ηp2=.853) and among sessions (F3,27 = 82.588; P < .001; ηp2=.902), with a significant interaction for group × time (F3,27 = 19.841; P < .001; ηp2=.688).","[{'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Chaves', 'Affiliation': ''}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Simões', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Paço', 'Affiliation': ''}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Silva', 'Affiliation': ''}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Pinho', 'Affiliation': ''}, {'ForeName': 'José Alberto', 'Initials': 'JA', 'LastName': 'Duarte', 'Affiliation': ''}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Ribeiro', 'Affiliation': ''}]",Journal of sport rehabilitation,['10.1123/jsr.2019-0046']
2036,30712391,Esmirtazapine treatment of postmenopausal vasomotor symptoms: two randomized controlled trials.,"OBJECTIVES


Two identical 12-week, randomized, double-blind, placebo-controlled, multi-arm, parallel-group Phase III studies (Study P012, NCT00560833; Study P013, NCT00535288) evaluated the efficacy and safety of esmirtazapine, an investigational medicine, for the treatment of moderate to severe vasomotor symptoms (VMS) in postmenopausal women.
METHODS


Participants were randomized to placebo or esmirtazapine (2.25, 4.5, 9.0, or 18.0 mg). Co-primary efficacy endpoints (daily frequency and severity of moderate to severe VMS, both at weeks 4 and 12) were based on participative LogPad daily diaries. Adverse events (AEs) were recorded.
RESULTS


In Studies P012 and P013, 942 and 946 participants were randomized, respectively. Compared with placebo, esmirtazapine significantly reduced the mean daily frequency by 1.4-2.2 moderate to severe VMS at weeks 4 and 12 (both ≥4.5 mg) and mean daily severity by 0.06-0.08 symptoms at weeks 4 (≥4.5 mg) and 12 (9.0 mg P012; 18.0 mg P013 only). Esmirtazapine was generally well tolerated with a more favorable safety profile at lower doses. Somnolence and fatigue were the most frequently reported AEs.
CONCLUSIONS


Esmirtazapine reduced the frequency and severity of moderate to severe VMS associated with menopause and was generally well tolerated in the study population.",2019,"Compared with placebo, esmirtazapine significantly reduced the mean daily frequency by 1.4-2.2 moderate to severe VMS at weeks 4 and 12 (both ≥4.5 mg) and mean daily severity by 0.06-0.08 symptoms at weeks 4 (≥4.5 mg) and 12 (9.0 mg P012; 18.0 mg P013 only).","['moderate to severe vasomotor symptoms (VMS) in postmenopausal women', 'In Studies P012 and P013, 942 and 946 participants', 'postmenopausal vasomotor symptoms', 'Participants']","['esmirtazapine', 'placebo, esmirtazapine', 'placebo', 'Esmirtazapine', 'placebo or esmirtazapine']","['Somnolence and fatigue', 'mean daily frequency', 'Adverse events (AEs', 'mean daily severity']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2700014', 'cui_str': '(S)-Mirtazapine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",946.0,0.182822,"Compared with placebo, esmirtazapine significantly reduced the mean daily frequency by 1.4-2.2 moderate to severe VMS at weeks 4 and 12 (both ≥4.5 mg) and mean daily severity by 0.06-0.08 symptoms at weeks 4 (≥4.5 mg) and 12 (9.0 mg P012; 18.0 mg P013 only).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Birkhaeuser', 'Affiliation': 'a Division of Gynaecological Endocrinology and Reproductive Medicine, Department of Obstetrics & Gynaecology , University of Bern , Bern , Switzerland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bitzer', 'Affiliation': 'b Department of Obstetrics and Gynecology , University Hospital , Basel , Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Braat', 'Affiliation': 'c MSD , Oss , The Netherlands.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ramos', 'Affiliation': 'e MSD , Munich , Germany.'}]",Climacteric : the journal of the International Menopause Society,['10.1080/13697137.2018.1561664']
2037,30753861,A comprehensive multicomponent school-based educational intervention did not affect fruit and vegetable intake at the 14-year follow-up.,"The intake of fruit and vegetables is associated with beneficial health outcomes, and studies aimed at increasing fruit and vegetable intake lack long-term follow-up. The primary objective of this study was to evaluate the long-term (14-year) effects of a multicomponent school-based educational intervention targeted to increase fruit and vegetable intake in children. The secondary objective was to evaluate the potential synergistic effect between free school fruit and the educational program. A cluster randomized school-based intervention was initiated in 2001 in Norway, known as the Fruit and Vegetable Make the Marks study. In total, 38 schools were randomized; for the intervention (n = 18) and as control schools (n = 20). A subsample of the intervention schools (n = 9) were additionally given free school fruit, resulting in two intervention groups - one with and one without free fruit. Participants completed questionnaires in September 2001 (baseline, mean age 11.8), May 2002 (at the end of the intervention), May 2003, May 2005, September 2009 and throughout 2016 (mean age 26.5). Of 1950 participants, 982 (50.4%) completed the 14-year follow-up and were considered as the current study sample. Analysis yielded no 14-year effects of the educational program on fruit and vegetable intake. A synergistic effect between the educational program and free fruit was not observed either. Future studies might benefit from increased focus on more extensive parental involvement, increased home availability, and a longer intervention period. However, more long-term studies are needed to evaluate the effects of school-based interventions into adulthood. Trial registration number: Ethical approval and research clearance was obtained from The National Committees for Research Ethics in Norway (file number S-01076) and The Norwegian Centre for Research Data (file number 12395).",2019,Analysis yielded no 14-year effects of the educational program on fruit and vegetable intake.,"['children', 'Participants completed questionnaires in September 2001 (baseline, mean age 11.8), May 2002 (at the end of the intervention), May 2003, May 2005, September 2009 and throughout 2016 (mean age 26.5', 'Of 1950 participants, 982 (50.4%) completed the 14-year follow-up and were considered as the current study sample']","['multicomponent school-based educational intervention', 'comprehensive multicomponent school-based educational intervention', 'free school fruit, resulting in two intervention groups - one with and one without free fruit']","['long-term (14-year) effects', 'potential synergistic effect', 'fruit and vegetable intake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}]",38.0,0.0227398,Analysis yielded no 14-year effects of the educational program on fruit and vegetable intake.,"[{'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Øvrebø', 'Affiliation': 'Faculty of Health and Sport Sciences, Department of Public Health, Sport and Nutrition, University of Agder, Kristiansand, Norway. Electronic address: bente.ovrebo@uia.no.'}, {'ForeName': 'Tonje H', 'Initials': 'TH', 'LastName': 'Stea', 'Affiliation': 'Faculty of Health and Sport Sciences, Department of Public Health, Sport and Nutrition, University of Agder, Kristiansand, Norway. Electronic address: tonje.h.stea@uia.no.'}, {'ForeName': 'Saskia J', 'Initials': 'SJ', 'LastName': 'Te Velde', 'Affiliation': 'Faculty of Health and Sport Sciences, Department of Public Health, Sport and Nutrition, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Bjelland', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway. Electronic address: mona.bjelland@medisin.uio.no.'}, {'ForeName': 'Knut-Inge', 'Initials': 'KI', 'LastName': 'Klepp', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway. Electronic address: Knut-Inge.Klepp@fhi.no.'}, {'ForeName': 'Elling', 'Initials': 'E', 'LastName': 'Bere', 'Affiliation': 'Faculty of Health and Sport Sciences, Department of Public Health, Sport and Nutrition, University of Agder, Kristiansand, Norway; Department of Health and Inequalities & Centre for Evaluation of Public Health Measures, Norwegian Institute of Public Health, Oslo, Norway. Electronic address: elling.bere@uia.no.'}]",Preventive medicine,['10.1016/j.ypmed.2019.02.015']
2038,30817329,"Insights Into a ""Negative"" ICU Trial Derived From Gene Expression Profiling.","OBJECTIVES


Randomized controlled trials in the ICU often fail to show differences in endpoints between groups. We sought to explore reasons for this at a molecular level by analyzing transcriptomic data from a recent negative trial. Our objectives were to determine if randomization successfully balanced transcriptomic features between groups, to assess transcriptomic heterogeneity among the study subjects included, and to determine if the study drug had any effect at the gene expression level.
DESIGN


Bioinformatics analysis of transcriptomic and clinical data collected in the course of a randomized controlled trial.
SETTING


Tertiary academic mixed medical-surgical ICU.
PATIENTS


Adult, critically ill patients expected to require invasive mechanical ventilation more than 48 hours.
INTERVENTIONS


Lactoferrin or placebo delivered enterally and via an oral swab for up to 28 days.
MEASUREMENTS AND MAIN RESULTS


We found no major imbalances in transcriptomic features between groups. Unsupervised analysis did not reveal distinct clusters among patients at the time of enrollment. There were marked differences in gene expression between early and later time points. Patients in the lactoferrin group showed changes in the expression of genes associated with immune pathways known to be associated with lactoferrin.
CONCLUSIONS


In this clinical trial, transcriptomic data provided a useful complement to clinical data, suggesting that the reasons for the negative result were less likely related to the biological efficacy of the study drug, and may instead have been related to poor sensitivity of the clinical outcomes. In larger studies, transcriptomics may also prove useful in predicting response to treatment.",2019,"Patients in the lactoferrin group showed changes in the expression of genes associated with immune pathways known to be associated with lactoferrin.
","['Adult, critically ill patients expected to require invasive mechanical ventilation more than 48 hours', 'Tertiary academic mixed medical-surgical ICU']","['Lactoferrin or placebo', 'lactoferrin']","['gene expression', 'transcriptomic features']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0017262', 'cui_str': 'Gene Expression'}]",,0.255209,"Patients in the lactoferrin group showed changes in the expression of genes associated with immune pathways known to be associated with lactoferrin.
","[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hoekstra', 'Affiliation': ""Department of Critical Care Medicine, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Maslove', 'Affiliation': ''}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Veldhoen', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Marshall', 'Affiliation': ""Critical Illness and Injury Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Muscedere', 'Affiliation': ""Department of Critical Care Medicine, Queen's University, Kingston, ON, Canada.""}]",Critical care medicine,['10.1097/CCM.0000000000003693']
2039,31521496,Lavage through percutaneous catheter drains in severe acute pancreatitis: Does it help?A randomized control trial.,"AIMS


There is no study comparing large volume lavage through image guided percutaneously placed drains in severe acute pancreatitis.
METHODS


Of the 114 randomized patients, 60 eligible candidates were randomly allocated to - Lavage Treatment (LT) group (28 patients) and Dependent Drainage (DD) group (32 patients). Primary end point was reversal of pre-existing organ failure, development of new onset organ failure, need for surgery, mortality and hospital stay.
RESULTS


Both the groups were comparable in terms of demographic data, onset and severity of pancreatitis. LT group had higher infected pancreatic necrosis (75% vs 50%,p = 0.047). On intention to treat analysis, lavage treatment group showed a significant reversal of persistent organ failure (84% vs 50%, p = 0.23), reduction in APACHEII scores (3.5 ± 3.405 vs 1.16 ± 3.811 p = 0.012), as measured at the time of placement of PCD to cessation of intervention. There was no difference in development of new onset organ failure in the two groups (25% vs37.5% p=.290). 75% in LT group and 69% in DD group improved with PCD alone. There was no difference in the catheter related complications and number of catheters used. The need for surgical intervention was comparable in two groups (18.8% vs 14.3% p=.737). There was a trend toward decreased mortality in group A (18.8% vs 28.8% p=.370).
CONCLUSION


Large volume lavage trough PCD improves organ failure and this translates into trend towards reduced mortality.",2019,The need for surgical intervention was comparable in two groups (18.8% vs 14.3% p=.737).,"['severe acute pancreatitis', '60 eligible candidates', 'Of the 114 randomized patients']","['PCD', ' Lavage Treatment (LT) group (28 patients) and Dependent Drainage (DD', 'Lavage through percutaneous catheter drains']","['reduction in APACHEII scores', 'mortality', 'pancreatic necrosis', 'development of new onset organ failure', 'Large volume lavage trough', 'reversal of persistent organ failure', 'demographic data, onset and severity of pancreatitis', 'reversal of pre-existing organ failure, development of new onset organ failure, need for surgery, mortality and hospital stay', 'organ failure']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis (disorder)'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0267953', 'cui_str': 'Necrosis of pancreas (disorder)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction (disorder)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",114.0,0.0846528,The need for surgical intervention was comparable in two groups (18.8% vs 14.3% p=.737).,"[{'ForeName': 'Pavneet', 'Initials': 'P', 'LastName': 'Kohli', 'Affiliation': 'Department of General Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Department of General Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India. Electronic address: vikaspgi@gmail.com.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Kochhar', 'Affiliation': 'Gastroenterology, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India.'}, {'ForeName': 'Thakur D', 'Initials': 'TD', 'LastName': 'Yadav', 'Affiliation': 'Department of General Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India.'}, {'ForeName': 'Saroj K', 'Initials': 'SK', 'LastName': 'Sinha', 'Affiliation': 'Gastroenterology, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India.'}, {'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Lal', 'Affiliation': 'Radiodiagnosis, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India.'}]",Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.],['10.1016/j.pan.2019.09.003']
2040,30829117,Robot-assisted gait training is not superior to intensive overground walking in multiple sclerosis with severe disability (the RAGTIME study): A randomized controlled trial.,"BACKGROUND


Rehabilitation may attenuate the impact on mobility of patients with progressive multiple sclerosis (MS) and severe gait disabilities.
OBJECTIVE


In this randomized controlled trial, we compared robot-assisted gait training (RAGT) with conventional therapy (CT) in terms of gait speed, mobility, balance, fatigue and quality of life (QoL).
METHODS


Seventy-two patients with MS (expanded disability status scale score 6.0-7.0) were randomized to receive 12 training sessions over a 4-week period of RAGT ( n  = 36) or overground walking therapy ( n  = 36). The primary outcome was gait speed, assessed by the timed 25-foot walk test. Secondary outcome measures were walking endurance, balance, depression, fatigue and QoL. Tests were performed at baseline, intermediate, at the end of treatment and at a 3-month follow-up.
RESULTS


Sixty-six patients completed the treatments. At the end of treatment with respect to baseline, both groups significantly improved gait speed ( p  < 0.001) and most secondary outcomes without between-group differences. Outcome values returned to baseline at follow-up.
CONCLUSIONS


RAGT was not superior to CT in improving gait speed in patients with progressive MS and severe gait disabilities where a positive, even transitory, effect of rehabilitation was observed.",2020,"At the end of treatment with respect to baseline, both groups significantly improved gait speed ( p < 0.001) and most secondary outcomes without between-group differences.","['patients with progressive multiple sclerosis (MS) and severe gait disabilities', '\n\n\nSeventy-two patients with MS (expanded disability status scale score 6.0-7.0', 'multiple sclerosis with severe disability']","['12 training sessions over a 4-week period of RAGT ( n\u2009=\u200936) or overground walking therapy', 'robot-assisted gait training (RAGT) with conventional therapy (CT', 'RAGT', 'CT', 'Robot-assisted gait training']","['gait speed, mobility, balance, fatigue and quality of life (QoL', 'walking endurance, balance, depression, fatigue and QoL. Tests', 'gait speed, assessed by the timed 25-foot walk test', 'gait speed', 'severe gait disabilities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]",72.0,0.102542,"At the end of treatment with respect to baseline, both groups significantly improved gait speed ( p < 0.001) and most secondary outcomes without between-group differences.","[{'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Straudi', 'Affiliation': 'Department of Neuroscience and Rehabilitation, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Manfredini', 'Affiliation': 'Department of Neuroscience and Rehabilitation, University Hospital of Ferrara, Ferrara, Italy/ Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lamberti', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Martinuzzi', 'Affiliation': 'Department of Neuroscience and Rehabilitation, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Maietti', 'Affiliation': 'Center for Clinical Epidemiology, Department of Medical Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Nino', 'Initials': 'N', 'LastName': 'Basaglia', 'Affiliation': 'Department of Neuroscience and Rehabilitation, University Hospital of Ferrara, Ferrara, Italy/ Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458519833901']
2041,30890314,Barbed Versus Conventional Suture for Uterine Repair During Caesarean Section: A Randomized Controlled Study.,"OBJECTIVE


This study sought to compare the short-term outcome of uterine incision repair during a Caesarean section (CS) using a bidirectional knotless barbed suture versus polyglactin suture.
METHODS


A randomized controlled trial was conducted at a university hospital. Participants undergoing a CS were randomly assigned to uterine incision closure by bidirectional knotless barbed suture (group A) or polyglactin (group B). The primary outcome was the time needed to repair the uterine incision. The analysis was by intent to treat. A sample size of 35 per group (n = 70) was planned to detect a 30% reduction in uterine repair time (Canadian Task Force Classification I).
RESULTS


From July 2016 through October 2017, 150 women were screened, and 70 were statistically analyzed: group A (n = 35) and group B (n = 35). Time to complete uterine incision repair was 308 ± 57 seconds for group A and 411 ± 74 seconds for group B (P < 0.001). Total surgery time (33.4 ± 8.8 minutes vs. 33.2 ± 7.5 minutes; P = 0.64) was not significantly different between groups A and B, respectively.
CONCLUSION


Repair of the CS uterine incision with barbed suture compared with polyglactin suture reduces suturing time.",2019,Time to complete uterine incision repair was 308 ± 57 seconds for group A and 411 ± 74 seconds for group B (P< 0.001).,"['Participants undergoing a CS', 'During Caesarean Section', 'From July 2016 through October 2017, 150 women were screened, and 70 were statistically analyzed: group A (n\u202f=\u202f35) and group B (n\u202f=\u202f35']","['uterine incision closure by bidirectional knotless barbed suture (group A) or polyglactin', 'polyglactin suture', 'uterine incision repair during a Caesarean section (CS', 'bidirectional knotless barbed suture versus polyglactin suture', 'Barbed Versus Conventional Suture forUterine Repair', 'CS uterine incision with barbed suture']","['time needed to repair the uterine incision', 'uterine repair time (Canadian Task Force Classification I', 'Total surgery time', 'Time to complete uterine incision repair', 'suturing time']","[{'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}]","[{'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0032494', 'cui_str': 'Poly(Lactide-Co-Glycoside)'}, {'cui': 'C0183740', 'cui_str': 'Polyglactin suture'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0195379', 'cui_str': 'Repair of uterus (procedure)'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0162458', 'cui_str': 'Task Forces'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}]",150.0,0.337964,Time to complete uterine incision repair was 308 ± 57 seconds for group A and 411 ± 74 seconds for group B (P< 0.001).,"[{'ForeName': 'Leonti', 'Initials': 'L', 'LastName': 'Grin', 'Affiliation': 'Department of Obstetrics and Gynecology, Barzilai University Medical Center, Faculty of Health Sciences, Ben-Gurion University of Negev, Ashkelon, Israel.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Namazov', 'Affiliation': 'Department of Obstetrics and Gynecology, Barzilai University Medical Center, Faculty of Health Sciences, Ben-Gurion University of Negev, Ashkelon, Israel. Electronic address: enamazov@gmail.com.'}, {'ForeName': 'Ale', 'Initials': 'A', 'LastName': 'Ivshin', 'Affiliation': 'Department of Obstetrics and Gynecology, Barzilai University Medical Center, Faculty of Health Sciences, Ben-Gurion University of Negev, Ashkelon, Israel.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Rabinovich', 'Affiliation': 'Department of Obstetrics and Gynecology, Barzilai University Medical Center, Faculty of Health Sciences, Ben-Gurion University of Negev, Ashkelon, Israel.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Shochat', 'Affiliation': 'Department of Obstetrics and Gynecology, Barzilai University Medical Center, Faculty of Health Sciences, Ben-Gurion University of Negev, Ashkelon, Israel.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Shenhav', 'Affiliation': 'Department of Obstetrics and Gynecology, Barzilai University Medical Center, Faculty of Health Sciences, Ben-Gurion University of Negev, Ashkelon, Israel.'}, {'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Gemer', 'Affiliation': 'Department of Obstetrics and Gynecology, Barzilai University Medical Center, Faculty of Health Sciences, Ben-Gurion University of Negev, Ashkelon, Israel.'}, {'ForeName': 'Efraim', 'Initials': 'E', 'LastName': 'Zohav', 'Affiliation': 'Department of Obstetrics and Gynecology, Barzilai University Medical Center, Faculty of Health Sciences, Ben-Gurion University of Negev, Ashkelon, Israel.'}, {'ForeName': 'Eyal Y', 'Initials': 'EY', 'LastName': 'Anteby', 'Affiliation': 'Department of Obstetrics and Gynecology, Barzilai University Medical Center, Faculty of Health Sciences, Ben-Gurion University of Negev, Ashkelon, Israel.'}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2019.01.011']
2042,31148155,Amustaline-glutathione pathogen-reduced red blood cell concentrates for transfusion-dependent thalassaemia.,"Transfusion-dependent thalassaemia (TDT) requires red blood cell concentrates (RBCC) to prevent complications of anaemia, but carries risk of infection. Pathogen reduction of RBCC offers potential to reduce infectious risk. We evaluated the efficacy and safety of pathogen-reduced (PR) Amustaline-Glutathione (A-GSH) RBCC for TDT. Patients were randomized to a blinded 2-period crossover treatment sequence for six transfusions over 8-10 months with Control and A-GSH-RBCC. The efficacy outcome utilized non-inferiority analysis with 90% power to detect a 15% difference in transfused haemoglobin (Hb), and the safety outcome was the incidence of antibodies to A-GSH-PR-RBCC. By intent to treat (80 patients), 12·5 ± 1·9 RBCC were transfused in each period. Storage durations of A-GSH and C-RBCC were similar (8·9 days). Mean A-GSH-RBCC transfused Hb (g/kg/day) was not inferior to Control (0·113 ± 0·04 vs. 0·111 ± 0·04, P = 0·373, paired t-test). The upper bound of the one-sided 95% confidence interval for the treatment difference from the mixed effects model was 0·005 g/kg/day, within a non-inferiority margin of 0·017 g/kg/day. A-GSH-RBCC mean pre-transfusion Hb levels declined by 6·0 g/l. No antibodies to A-GSH-RBCC were detected, and there were no differences in adverse events. A-GSH-RBCCs offer potential to reduce infectious risk in TDT with a tolerable safety profile.",2019,"No antibodies to A-GSH-RBCC were detected, and there were no differences in adverse events.",['transfusion-dependent thalassaemia'],"['Control and A-GSH-RBCC', 'pathogen-reduced (PR) Amustaline-Glutathione (A-GSH) RBCC', 'Transfusion-dependent thalassaemia (TDT', 'Amustaline-glutathione pathogen-reduced red blood cell concentrates']","['Storage durations of A-GSH and C-RBCC', 'adverse events', 'transfused haemoglobin (Hb']","[{'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0039730', 'cui_str': 'Thalassemia'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0039730', 'cui_str': 'Thalassemia'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}]","[{'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0729722,"No antibodies to A-GSH-RBCC were detected, and there were no differences in adverse events.","[{'ForeName': 'Yesim', 'Initials': 'Y', 'LastName': 'Aydinok', 'Affiliation': 'Department of Paediatric Haematology and Oncology, Ege University Hospital, Izmir, Turkey.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Piga', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Origa', 'Affiliation': 'Ospedale Pediatrico Microcitemico, Universita di Cagliari, Cagliari, Italy.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Mufti', 'Affiliation': 'Cerus Corporation, Concord, CA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Erickson', 'Affiliation': 'Cerus Corporation, Concord, CA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'North', 'Affiliation': 'Cerus Corporation, Concord, CA, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Waldhaus', 'Affiliation': 'Cerus Corporation, Concord, CA, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Ernst', 'Affiliation': 'Cerus Corporation, Concord, CA, USA.'}, {'ForeName': 'Jin-Sying', 'Initials': 'JS', 'LastName': 'Lin', 'Affiliation': 'Cerus Corporation, Concord, CA, USA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Huang', 'Affiliation': 'Cerus Corporation, Concord, CA, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Benjamin', 'Affiliation': 'Cerus Corporation, Concord, CA, USA.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Corash', 'Affiliation': 'Cerus Corporation, Concord, CA, USA.'}]",British journal of haematology,['10.1111/bjh.15963']
2043,30809728,Is three-dimensional laparoscopic spleen preserving splenic hilar lymphadenectomy for gastric cancer better than that of two-dimensional? Analysis of a prospective clinical research study.,"BACKGROUND


Three-dimensional (3D) systems for laparoscopy provide surgeons with additional information on spatial depth not found in two-dimensional (2D) systems.
METHODS


This study enrolled 156 spleen-preserving splenic hilar lymphadenectomy (LSPSHL) patients in a randomized controlled trial (ClinicalTrials.gov Identifier NCT02327481) at the department of gastric surgery at Fujian Medical University Union Hospital between January 2015 and April 2016. The short-term efficacies were compared between the treatment groups. The unedited videos of 80 LSPSHL (40 procedures each for 3D and 2D) were rated for technical performance using the Generic Error Rating Tool.
RESULTS


The data for 156 LSPSHL patients indicate that the estimated blood loss (EBL) (3D vs 2D = 66.3 vs. 99.0, P = 0.046) was significantly less in the 3D group. The postoperative recovery and complication rates were similar (P > 0.05). And there were no deaths within 30 days of surgery. Two observers analyzed 80 videos of LSPSHL. The results showed that there were fewer grasping-errors made in the 3D group than in the 2D group when dissecting the inferior pole region of spleen (IPRS) (P = 0.016) and the superior pole region of spleen (SPRS) (P = 0.022). Additionally, the inter-rater reliability was high regarding grasping-errors in the IPRS (intraclass correlation coefficient (ICC) 0.92) and in the SPRS (ICC 0.83). The ICC for the total number of errors was 0.82. The mean of errors in the 3D group (3D vs. 2D = 20.7 vs. 23.5, P = 0.022) was less than the 2D group.
CONCLUSIONS


Compared with 2D LSPSHL, 3D technology reduces EBL and technical errors during splenic hilar dissection.",2019,The results showed that there were fewer grasping-errors made in the 3D group than in the 2D group when dissecting the inferior pole region of spleen (IPRS) (P = 0.016) and the superior pole region of spleen (SPRS) (P = 0.022).,['156 spleen-preserving splenic hilar lymphadenectomy (LSPSHL) patients in a randomized controlled trial (ClinicalTrials.gov Identifier NCT02327481) at the department of gastric surgery at Fujian Medical University Union Hospital between January 2015 and April 2016'],[],"['postoperative recovery and complication rates', 'grasping-errors', 'inferior pole region of spleen (IPRS', 'estimated blood loss (EBL', 'mean of errors', 'EBL and technical errors', 'superior pole region of spleen (SPRS']","[{'cui': 'C0037993', 'cui_str': 'Spleen'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0205150', 'cui_str': 'Hilar'}, {'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0220843', 'cui_str': 'Grip'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0337815', 'cui_str': 'Poles (ethnic group)'}, {'cui': 'C1282338', 'cui_str': 'Region of spleen'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0626314', 'cui_str': 'SPRS'}]",156.0,0.0626903,The results showed that there were fewer grasping-errors made in the 3D group than in the 2D group when dissecting the inferior pole region of spleen (IPRS) (P = 0.016) and the superior pole region of spleen (SPRS) (P = 0.022).,"[{'ForeName': 'Zhi-Yu', 'Initials': 'ZY', 'LastName': 'Liu', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, No. 29 Xinquan Road, Fuzhou, 350001, Fujian Province, China.'}, {'ForeName': 'Qi-Yue', 'Initials': 'QY', 'LastName': 'Chen', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, No. 29 Xinquan Road, Fuzhou, 350001, Fujian Province, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhong', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, No. 29 Xinquan Road, Fuzhou, 350001, Fujian Province, China.'}, {'ForeName': 'Jian-Wei', 'Initials': 'JW', 'LastName': 'Xie', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, No. 29 Xinquan Road, Fuzhou, 350001, Fujian Province, China.'}, {'ForeName': 'Jia-Bin', 'Initials': 'JB', 'LastName': 'Wang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, No. 29 Xinquan Road, Fuzhou, 350001, Fujian Province, China.'}, {'ForeName': 'Jian-Xian', 'Initials': 'JX', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, No. 29 Xinquan Road, Fuzhou, 350001, Fujian Province, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, No. 29 Xinquan Road, Fuzhou, 350001, Fujian Province, China.'}, {'ForeName': 'Long-Long', 'Initials': 'LL', 'LastName': 'Cao', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, No. 29 Xinquan Road, Fuzhou, 350001, Fujian Province, China.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, No. 29 Xinquan Road, Fuzhou, 350001, Fujian Province, China.'}, {'ForeName': 'Ru-Hong', 'Initials': 'RH', 'LastName': 'Tu', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, No. 29 Xinquan Road, Fuzhou, 350001, Fujian Province, China.'}, {'ForeName': 'Ze-Ning', 'Initials': 'ZN', 'LastName': 'Huang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, No. 29 Xinquan Road, Fuzhou, 350001, Fujian Province, China.'}, {'ForeName': 'Ju-Li', 'Initials': 'JL', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, No. 29 Xinquan Road, Fuzhou, 350001, Fujian Province, China.'}, {'ForeName': 'Hua-Long', 'Initials': 'HL', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, No. 29 Xinquan Road, Fuzhou, 350001, Fujian Province, China.'}, {'ForeName': 'Chao-Hui', 'Initials': 'CH', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, No. 29 Xinquan Road, Fuzhou, 350001, Fujian Province, China. wwkzch@163.com.'}, {'ForeName': 'Chang-Ming', 'Initials': 'CM', 'LastName': 'Huang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, No. 29 Xinquan Road, Fuzhou, 350001, Fujian Province, China. hcmlr2002@163.com.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, No. 29 Xinquan Road, Fuzhou, 350001, Fujian Province, China. pingli811002@163.com.'}]",Surgical endoscopy,['10.1007/s00464-018-06640-7']
2044,31082689,Comment on 'Randomised phase 2 study of pembrolizumab plus CC-486 versus pembrolizumab plus placebo in patients with previously treated advanced non-small cell lung cancer'-No support for de-escalation of immunotherapy.,,2019,,"[""patients with previously treated advanced non-small cell lung cancer'-No support for de-escalation of immunotherapy""]",['pembrolizumab plus CC-486 versus pembrolizumab plus placebo'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0621534,,"[{'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Georgiou', 'Affiliation': 'The Royal Marsden Hospital Foundation Trust, UK. Electronic address: a.georgiou@nhs.net.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Minchom', 'Affiliation': 'The Royal Marsden Hospital Foundation Trust, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': ""O'Brien"", 'Affiliation': 'The Royal Marsden Hospital Foundation Trust, UK.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.04.011']
2045,31598912,Treatment of metabolic acidosis with sodium bicarbonate delays progression of chronic kidney disease: the UBI Study.,"BACKGROUND


Metabolic acidosis is associated with accelerated progression of chronic kidney disease (CKD). Whether treatment of metabolic acidosis with sodium bicarbonate improves kidney and patient survival in CKD is unclear.
METHODS


We conducted a randomized (ratio 1:1). open-label, controlled trial (NCT number: NCT01640119. www.clinicaltrials.gov ) to determine the effect in patients with CKD stage 3-5 of treatment of metabolic acidosis with sodium bicarbonate (SB) on creatinine doubling (primary endpoint), all-cause mortality and time to renal replacement therapy compared to standard care (SC) over 36-months. Parametric, non-parametric tests and survival analyses were used to assess the effect of SB on these outcomes.
RESULTS


A total of 376 and 364 individuals with mean (SD) age 67.8 (14.9) years, creatinine clearance 30 (12) ml/min, and serum bicarbonate 21.5 (2.4) mmol/l were enrolled in SB and SC, respectively. Mean (SD) follow-up was 29.6 (9.8) vs 30.3 (10.7) months in SC and SB. respectively. The mean (SD) daily doses of SB was 1.13 (0.10). 1.12 (0.11). and 1.09 (0.12) mmol/kg*bw/day in the first, second and third year of follow-up, respectively. A total of 87 participants reached the primary endpoint [62 (17.0%) in SC vs 25 (6.6%) in SB, p < 0.001). Similarly, 71 participants [45 (12.3%) in SC and 26 (6.9%) in SB, p = 0.016] started dialysis while 37 participants [25 (6.8%) in SC and 12 (3.1%) in SB, p = 0.004] died. There were no significant effect of SB on blood pressure, total body weight or hospitalizations.
CONCLUSION


In persons with CKD 3-5 without advanced stages of chronic heart failure, treatment of metabolic acidosis with sodium bicarbonate is safe and improves kidney and patient survival.",2019,"A total of 87 participants reached the primary endpoint [62 (17.0%) in SC vs 25 (6.6%) in SB, p < 0.001).","['chronic kidney disease', 'A total of 376 and 364 individuals with mean (SD) age 67.8 (14.9) years, creatinine clearance 30 (12) ml/min, and serum bicarbonate 21.5 (2.4) mmol', 'patients with CKD stage 3-5 of treatment of metabolic acidosis with']","['SB', 'sodium bicarbonate (SB', 'sodium bicarbonate', 'renal replacement therapy compared to standard care (SC']","['blood pressure, total body weight or hospitalizations', 'mean (SD) daily doses of SB', 'kidney and patient survival']","[{'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2316787', 'cui_str': 'CKD stage 3'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis (disorder)'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",71.0,0.0598872,"A total of 87 participants reached the primary endpoint [62 (17.0%) in SC vs 25 (6.6%) in SB, p < 0.001).","[{'ForeName': 'Biagio R', 'Initials': 'BR', 'LastName': 'Di Iorio', 'Affiliation': 'Nephrology and Dialysis Unit, PO ""A. Landolfi"", Solofra, Avellino, Italy. br.diiorio@gmail.com.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bellasi', 'Affiliation': 'Department of Research, Innovation, Brand Reputation, Bergamo Hospital, ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Kalani L', 'Initials': 'KL', 'LastName': 'Raphael', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Internal Medicine, University of Utah Health, Salt Lake City, UT, USA.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Santoro', 'Affiliation': 'Dialysis and Nephrology Unit, University of Messina, Messina, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Aucella', 'Affiliation': 'Department of Nephrology and Dialysis, IRCCS ""Casa Sollievo della Sofferenza"", San Giovanni Rotondo, Foggia, Italy.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Garofano', 'Affiliation': 'Biogem, Section of Genetic and Translational Medicine, Ariano Irpino, Avellino, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Ceccarelli', 'Affiliation': 'Biogem, Section of Genetic and Translational Medicine, Ariano Irpino, Avellino, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Di Lullo', 'Affiliation': 'Department of Nephrology and Dialysis, ""L. Parodi-Delfino"" Hospital, Colleferro, Roma, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Capolongo', 'Affiliation': 'Department of Translational Medical Sciences, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Di Iorio', 'Affiliation': 'Data Scientist, Landolfi Nephrology Dialysis Consultant, Solofra, Avellino, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Guastaferro', 'Affiliation': 'Department of Nephrology, ""G. Criscuoli"" Hospital, Sant\'Angelo dei Lombardi, Avellino, Italia.'}, {'ForeName': 'Giovambattista', 'Initials': 'G', 'LastName': 'Capasso', 'Affiliation': 'Department of Nephrology and Dialysis, IRCCS ""Casa Sollievo della Sofferenza"", San Giovanni Rotondo, Foggia, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of nephrology,['10.1007/s40620-019-00656-5']
2046,31748594,A Four Month Randomized Controlled Trial on the Efficacy of Once-daily Fenofibrate Monotherapy in Persons with Spinal Cord Injury.,"An open-label, randomized clinical trial of once-daily fenofibrate monotherapy administered for 2- (Mo2) and 4- (Mo4) months using modified intervention thresholds for triglyceride (TG) was performed in persons with chronic spinal cord injury (SCI). Fenofibrate (145 mg tablet) was self-administered daily in 10 persons with SCI for 4 months with monthly blood testing to quantify the lipoprotein profile (e.g., serum TG, LDL-C, and HDL-C concentrations). Eight SCI participants were control subjects. In comparison to the control group, the treatment group at Mo2 had a 40% (±12%; p < 0.05) reduction in serum TG concentration, a 28% (±21%; p < 0.05) increase in HDL-C and 14% (±20%; p < 0.05) decline in LDL-C. In the same comparison at Mo4, the treatment group maintained a 40% (±20%; p < 0.05) reduction in serum TG concentration, had an 18% in reduction in LDL-C (±12%; p < 0.05) and a 23% (±23%; p < 0.05) increase in HDL-C. Fenofibrate monotherapy for Mo2 and Mo4 initiated in persons with SCI resulted in a robust and favorable change in the serum lipoprotein profile and ratios, suggesting reduced risk for cardiovascular disease.",2019,"In the same comparison at Mo4, the treatment group maintained a 40% (±20%; p < 0.05) reduction in serum TG concentration, had an 18% in reduction in LDL-C (±12%; p < 0.05) and a 23% (±23%; p < 0.05) increase in HDL-C. Fenofibrate monotherapy for Mo2 and Mo4 initiated in persons with SCI resulted in a robust and favorable change in the serum lipoprotein profile and ratios, suggesting reduced risk for cardiovascular disease.","['persons with chronic spinal cord injury (SCI', 'Persons with Spinal Cord Injury', 'Eight SCI participants were control subjects']","['Fenofibrate', 'Once-daily Fenofibrate Monotherapy', 'fenofibrate monotherapy administered for 2- (Mo2) and 4- (Mo4) months using modified intervention thresholds for triglyceride (TG']","['HDL-C', 'serum TG concentration', 'LDL-C', 'serum lipoprotein profile and ratios']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0196628,"In the same comparison at Mo4, the treatment group maintained a 40% (±20%; p < 0.05) reduction in serum TG concentration, had an 18% in reduction in LDL-C (±12%; p < 0.05) and a 23% (±23%; p < 0.05) increase in HDL-C. Fenofibrate monotherapy for Mo2 and Mo4 initiated in persons with SCI resulted in a robust and favorable change in the serum lipoprotein profile and ratios, suggesting reduced risk for cardiovascular disease.","[{'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'La Fountaine', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, NY, USA. michael.lafountaine@va.gov.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Cirnigliaro', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Joshua C', 'Initials': 'JC', 'LastName': 'Hobson', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Lombard', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Adam F', 'Initials': 'AF', 'LastName': 'Specht', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Trevor A', 'Initials': 'TA', 'LastName': 'Dyson-Hudson', 'Affiliation': 'Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Kirshblum', 'Affiliation': 'Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Bauman', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, NY, USA.'}]",Scientific reports,['10.1038/s41598-019-53753-7']
2047,31153882,Early TIPS with covered stents versus standard treatment for acute variceal bleeding in patients with advanced cirrhosis: a randomised controlled trial.,"BACKGROUND


The survival benefit of early placement of transjugular intrahepatic portosystemic shunts (TIPS) in patients with cirrhosis and acute variceal bleeding is controversial. We aimed to assess whether early TIPS improves survival in patients with advanced cirrhosis and acute variceal bleeding.
METHODS


We did an investigator-initiated, open-label, randomised controlled trial at an academic hospital in China. Consecutive patients with advanced cirrhosis (Child-Pugh class B or C) and acute variceal bleeding who had been treated with vasoactive drugs plus endoscopic therapy were randomly assigned (2:1) to receive either early TIPS (done within 72 h after initial endoscopy [early TIPS group]) or standard treatment (vasoactive drugs continued to day 5, followed by propranolol plus endoscopic band ligation for the prevention of rebleeding, with TIPS as rescue therapy when needed [control group]). Randomisation was done by web-based randomisation system using a Pocock and Simon's minimisation method with Child-Pugh class (B vs C) and presence or absence of active bleeding as adjustment factors. The primary outcome was transplantation-free survival, analysed in the intention-to-treat population, excluding individuals subsequently found to be ineligible for enrolment. This study is registered with ClinicalTrials.gov, number NCT01370161, and is completed.
FINDINGS


From June 26, 2011, to Sept 30, 2017, 373 patients were screened and 132 patients were randomly assigned to the early TIPS group (n=86) or to the control group (n=46). After exclusion of three individuals subsequently found to be ineligible for enrolment (two patients in the early TIPS group with non-cirrhotic portal hypertension or hepatocellular carcinoma, and one patient in the control group due to non-cirrhotic portal hypertension), 84 patients in the early TIPS group and 45 patients in the control group were included in the intention-to-treat population. 15 (18%) patients in the early TIPS group and 15 (33%) in the control group died; two (2%) patients in the early TIPS group and one (2%) in the control group underwent liver transplantation. Transplantation-free survival was higher in the early TIPS group than in the control group (hazard ratio 0·50, 95% CI 0·25-0·98; p=0·04). Transplantation-free survival at 6 weeks was 99% (95% CI 97-100) in the early TIPS group compared with 84% (75-96; absolute risk difference 15% [95% CI 5-48]; p=0·02) and at 1 year was 86% (79-94) in the early TIPS group versus 73% (62-88) in the control group (absolute risk difference 13% [95% CI 2-28]; p=0·046). There were no significant differences between the two groups in the incidence of hepatic hydrothorax (two [2%] of 84 patients in the early TIPS group vs one [2%] of 45 in the control group; p=0·96), spontaneous bacterial peritonitis (one [1%] vs three [7%]; p=0·12), hepatic encephalopathy (29 [35%] vs 16 [36%]; p=1·00), hepatorenal syndrome (four [5%] vs six [13%]; p=0·10), and hepatocellular carcinoma (four [5%] vs one [2%]; p=0·68). There was no significant difference in the number of patients who experienced other serious adverse events (ten [12%] vs 11 [24%]; p=0·07) or non-serious adverse events (21 [25%] vs 19 [42%]; p=0·05) between groups.
INTERPRETATION


Early TIPS with covered stents improved transplantation-free survival in selected patients with advanced cirrhosis and acute variceal bleeding and should therefore be preferred to the current standard of care.
FUNDING


National Natural Science Foundation of China, National Key Technology R&D Program, Optimized Overall Project of Shaanxi Province, Boost Program of Xijing Hospital.",2019,Transplantation-free survival at 6 weeks was 99% (95% CI 97-100) in the early TIPS group compared with 84% (75-96; absolute risk difference 15% [95% CI 5-48]; p=0·02) and at 1 year was 86% (79-94) in the early TIPS group versus 73% (62-88) in the control group (absolute risk difference 13% [95% CI 2-28]; p=0·046).,"['patients with cirrhosis and acute variceal bleeding', 'academic hospital in China', 'patients with advanced cirrhosis', 'patients with advanced cirrhosis and acute variceal bleeding', 'Consecutive patients with advanced cirrhosis (Child-Pugh class B or C) and acute variceal bleeding who had been treated with vasoactive drugs plus endoscopic therapy', 'selected patients with advanced cirrhosis and acute variceal bleeding', 'From June 26, 2011, to Sept 30, 2017, 373 patients were screened and 132 patients']","['early TIPS (done within 72 h after initial endoscopy [early TIPS group]) or standard treatment (vasoactive drugs continued to day 5, followed by propranolol plus endoscopic band ligation', 'transjugular intrahepatic portosystemic shunts (TIPS', 'Early TIPS with covered stents versus standard treatment', 'early TIPS']","['survival', 'hepatic encephalopathy', 'hepatocellular carcinoma', 'serious adverse events', 'non-serious adverse events', 'transplantation-free survival', 'Transplantation-free survival', 'spontaneous bacterial peritonitis', 'hepatorenal syndrome', 'incidence of hepatic hydrothorax']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1263666', 'cui_str': 'Advanced cirrhosis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C1301416', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0019151', 'cui_str': 'Portal-Systemic Encephalopathy'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0275551', 'cui_str': 'Primary bacterial peritonitis (disorder)'}, {'cui': 'C0019212', 'cui_str': 'Hepatorenal Syndrome'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1963739', 'cui_str': 'Hepatic hydrothorax'}]",373.0,0.229334,Transplantation-free survival at 6 weeks was 99% (95% CI 97-100) in the early TIPS group compared with 84% (75-96; absolute risk difference 15% [95% CI 5-48]; p=0·02) and at 1 year was 86% (79-94) in the early TIPS group versus 73% (62-88) in the control group (absolute risk difference 13% [95% CI 2-28]; p=0·046).,"[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Chuangye', 'Initials': 'C', 'LastName': 'He', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Zhengyu', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Bai', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Wengang', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Tianlei', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Xulong', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Digestive Endoscopy, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Huahong', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': ""Department of Digestive Endoscopy, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Yao', 'Affiliation': ""Department of Digestive Endoscopy, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Ultrasound, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""Department of Ultrasound, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Qiuhe', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Enxin', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Dongdong', 'Initials': 'D', 'LastName': 'Xia', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Bohan', 'Initials': 'B', 'LastName': 'Luo', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Han', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': ""Department of Medical Statistics, School of Preventive Medicine, Fourth Military Medical University, Xi'an, China; Department of Technology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Jielai', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': ""Department of Medical Statistics, School of Preventive Medicine, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Zhanxin', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Kaichun', 'Initials': 'K', 'LastName': 'Wu', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Daiming', 'Initials': 'D', 'LastName': 'Fan', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Guohong', 'Initials': 'G', 'LastName': 'Han', 'Affiliation': ""Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China. Electronic address: hangh@fmmu.edu.cn.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30090-1']
2048,31153846,Absorb Bioresorbable Scaffold Versus Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis: Rationale and Design of the COMPARE ABSORB Trial.,"BACKGROUND


The advent of bioresorbable vascular scaffolds (BVS) was considered as a potential improvement in percutaneous coronary intervention (PCI) after the groundbreaking development of drug eluting stents (DES). However, the clinical performance, long-term safety and efficacy of BVS in complex coronary lesions remain uncertain. COMPARE ABSORB, a multicenter, single blind, prospective randomized trial, aims to compare the clinical outcomes between the Absorb BVS and Xience everolimus-eluting metallic stent (EES) in patients with coronary artery disease and a high risk of restenosis.
DESIGN


COMPARE ABSORB is designed to enroll 2100 patients at up to 45 European sites. Enrolled patients will possess high risk for restenosis due to clinical profile or coronary lesion complexity and will undergo elective or emergent PCI. Once included in the study, patients will receive either Absorb BVS or Xience EES. Specific advice on implantation technique including mandatory pre-dilatation, sizing and post-dilatation (PSP), will be used in the Absorb BVS arm. The primary endpoint is target lesion failure (TLF), a device-oriented composite endpoint (cardiac death, target vessel myocardial infarction and clinically-indicated target lesion revascularization). The trial is powered to assess non-inferiority of Absorb BVS compared with Xience EES with a predetermined non-inferiority margin of 4.5% at 1 year after index procedure. The clinical follow-up will continue for 7 years.
CONCLUSIONS


The prospective COMPARE ABSORB randomized trial (ClinicalTrials.govNCT02486068) will help to assess the long-term safety and efficacy of Absorb BVS compared with Xience EES in the treatments of patients with complex coronary artery disease and a high attendant risk of restenosis.",2019,"The primary endpoint is target lesion failure (TLF), a device-oriented composite endpoint (cardiac death, target vessel myocardial infarction and clinically-indicated target lesion revascularization).","['Enrolled patients will possess high risk for restenosis due to clinical profile or coronary lesion complexity and will undergo elective or emergent PCI', 'patients with complex coronary artery disease and a high attendant risk of restenosis', 'patients at high risk of restenosis', 'patients with coronary artery disease and a high risk of restenosis', 'enroll 2100 patients at up to 45 European sites']","['Absorb BVS', 'Specific advice on implantation technique including mandatory pre-dilatation, sizing and post-dilatation (PSP', 'Absorb BVS and Xience everolimus-eluting metallic stent (EES', 'percutaneous coronary intervention', 'Xience EES', 'Absorb bioresorbable scaffold versus Xience metallic stent', 'Absorb BVS or Xience EES', 'BVS']","['target lesion failure (TLF), a device-oriented composite endpoint (cardiac death, target vessel myocardial infarction and clinically-indicated target lesion revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1868193', 'cui_str': 'PSP'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}]","[{'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",,0.113332,"The primary endpoint is target lesion failure (TLF), a device-oriented composite endpoint (cardiac death, target vessel myocardial infarction and clinically-indicated target lesion revascularization).","[{'ForeName': 'Chun Chin', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands; Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taiwan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands; Cardialysis Clinical Trials Management and Core Laboratories, Rotterdam, the Netherlands.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Achenbach', 'Affiliation': 'Department of Cardiology, Universitätsklinikum Erlangen, Erlangen, Germany.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Barbato', 'Affiliation': 'Cardiovascular Research Center OLV Hospital, Aalst, Belgium.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chevalier', 'Affiliation': 'Ramsay Générale de Santé, ICPS, Hôpital Jacques Cartier, Massy, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': 'Department of Cardiology, Hospital and University Fribourg, Switzerland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Dudek', 'Affiliation': '2nd Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clinico San Carlos IDISSC, Complutense University, Madrid, Spain.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Gori', 'Affiliation': 'Center of Cardiology, Cardiology I, University Medical Center of the Johannes Gutenberg-University Mainz and DZHK Standort Rhein-Main, Mainz, Germany.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Kočka', 'Affiliation': 'Third Faculty of Medicine, Charles University and University Hospital Královske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Tarantini', 'Affiliation': 'Interventional Cardiology Unit, Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Italy.'}, {'ForeName': 'Nick E J', 'Initials': 'NEJ', 'LastName': 'West', 'Affiliation': 'Department of Interventional Cardiology, Royal Papworth Hospital, UK.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': 'Ramsay Générale de Santé, Hopital Privé Jacques Cartier, Massy, France.'}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'van Geuns', 'Affiliation': 'Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands; Cardiology Department, Radboud UMC, Nijmegen, the Netherlands.'}, {'ForeName': 'Pieter C', 'Initials': 'PC', 'LastName': 'Smits', 'Affiliation': 'Cardiology Department, Maasstad Hospital, Rotterdam, the Netherlands. Electronic address: SmitsP@maasstadziekenhuis.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiovascular revascularization medicine : including molecular interventions,['10.1016/j.carrev.2019.04.013']
2049,31855037,Gender differences in response to metacognitive training in people with first-episode psychosis.,"INTRODUCTION


The study aimed to assess gender differences in the efficacy of metacognitive training (MCT) in people with first-episode psychosis in terms of symptoms and cognitive insight as a primary outcome and other metacognitive and social cognition measures as a secondary outcome.
METHOD


A multicenter, controlled, randomized clinical trial was performed including 122 patients with first-episode psychosis. A total of 8 weekly group sessions of MCT or a psychoeducational intervention were performed. Patients were assessed at baseline, posttreatment, and follow-up. Symptoms were assessed with the Positive and Negative Syndrome Scale and cognitive insight with the Beck Cognitive Insight Scale. A battery of questionnaires on metacognition and social cognition variables was included to assess secondary outcomes. A regression model for repeated measures was performed by gender.
RESULTS


Women of the MCT group improved more in general symptoms (p = .046), self-certainty (p = .010), and a composite index of the cognitive insight (p = .031). Moreover, women in the MCT group showed a reduction in personalizing bias (p = .021) and irrational beliefs related to dependence (p = .024), while men in the MCT group showed an improvement in intolerance to frustration (p = .017). In the Jumping to Conclusions task, men in the MCT group improved in the affective task (p = .021) while no differences were found in women.
CONCLUSIONS


Our results suggest that MCT is more effective in reducing symptoms and improving cognitive insight for women than men. Moreover, different irrational beliefs and cognitive biases were reduced differently considering gender. MCT could be a gender-sensitive intervention. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"In the Jumping to Conclusions task, men in the MCT group improved in the affective task (p = .021) while no differences were found in women.
","['women than men', '122 patients with first-episode psychosis', 'people with first-episode psychosis']","['metacognitive training (MCT', 'MCT', 'metacognitive training']","['intolerance to frustration', 'cognitive insight', 'affective task', 'personalizing bias', 'composite index of the cognitive insight', 'metacognition and social cognition variables', 'self-certainty', 'irrational beliefs and cognitive biases', 'Positive and Negative Syndrome Scale and cognitive insight with the Beck Cognitive Insight Scale', 'general symptoms']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}]","[{'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0016770', 'cui_str': 'Frustration'}, {'cui': 'C0233820', 'cui_str': 'Self-understanding'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0589513', 'cui_str': 'Meta-cognition'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439543', 'cui_str': 'Certainties (qualifier value)'}, {'cui': 'C0542058', 'cui_str': 'Irrational'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C0159028', 'cui_str': 'General symptom (finding)'}]",2019.0,0.0402616,"In the Jumping to Conclusions task, men in the MCT group improved in the affective task (p = .021) while no differences were found in women.
","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Salas-Sender', 'Affiliation': 'Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'López-Carrilero', 'Affiliation': 'Research Institut Sant Joan de Déu, Parc Sanitari Sant Joan de Déu.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Barajas', 'Affiliation': ""Centre d'Higiene Mental Les Corts.""}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Lorente-Rovira', 'Affiliation': 'Hospital Clínico Universitario de Valencia.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Pousa', 'Affiliation': ""Department of Psychiatry, Institut d'Investigació Biomèdica-Sant Pau (IIBSant Pau), Hospital Santa Creu i Sant Pau.""}, {'ForeName': 'Maria Luisa', 'Initials': 'ML', 'LastName': 'Barrigón', 'Affiliation': 'Department of Psychiatry, Fundación IIS-Jimenez Diaz, Universidad Autónoma de Madrid.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Grasa', 'Affiliation': 'Department of Psychiatry, Biomèdica-Sant Pau Research Institute (IIBSant Pau), Hospital Santa Creu i Sant Pau.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Ruiz-Delgado', 'Affiliation': 'Community Mental Health Unit of Malaga Norte, Servicio Andaluz de Salud, UGC Salud Mental Carlos Haya.'}, {'ForeName': 'Fermín', 'Initials': 'F', 'LastName': 'González-Higueras', 'Affiliation': 'Therapeutic Community, Servicio Andaluz de Salud, UGC Salud Mental Jaén.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Cid', 'Affiliation': ""Institut d'Assistencia Sanitària.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Aznar', 'Affiliation': ""Centre d'Higiene Mental Les Corts.""}, {'ForeName': 'Trinidad', 'Initials': 'T', 'LastName': 'Pélaez', 'Affiliation': 'Research Institut Sant Joan de Déu, Parc Sanitari Sant Joan de Déu.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Birulés', 'Affiliation': 'Research Institut Sant Joan de Déu, Parc Sanitari Sant Joan de Déu.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg.'}, {'ForeName': '', 'Initials': '', 'LastName': 'The Spanish Metacognition Study Group', 'Affiliation': ''}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Ochoa', 'Affiliation': 'Research Institut Sant Joan de Déu, Parc Sanitari Sant Joan de Déu.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000468']
2050,31200321,Prognostic and predictive value of AJCC-8 staging in the phase III EORTC1325/KEYNOTE-054 trial of pembrolizumab vs placebo in resected high-risk stage III melanoma.,"BACKGROUND


The American Joint Committee on Cancer-8 (AJCC) classification of melanoma was implemented in January 2018. It was based on data gathered when checkpoint inhibitors were not used as adjuvant therapy in stage III melanoma. The European Organization for Research and Treatment of Cancer (EORTC) 1325/KEYNOTE-054 double-blind phase III trial evaluated pembrolizumab vs placebo in AJCC-7 stage IIIA (excluding lymph node metastasis ≤1 mm), IIIB or IIIC (without in-transit metastasis) patients after complete lymphadenectomy.
PATIENTS, METHODS AND RESULTS


Patients (n = 1019) were randomised 1:1 to pembrolizumab 200 mg or placebo every 3 weeks (total of 18 doses, ∼1 year). At 1.25-year median follow-up, pembrolizumab prolonged relapse-free survival (RFS) in the total population (1-year RFS rate: 75.4% vs 61.0%; hazard ratio [HR] 0.57; logrank P < 0.0001) and consistently in the AJCC-7 subgroups. Prognostic and predictive values of AJCC-8 for RFS were evaluated in this study. Patient distribution according to the AJCC-8 stage subgroups was 8% (IIIA), 34.7% (IIIB), 49.7% (IIIC), 3.7% (IIID) and 3.8% (unknown). AJCC-8 classification was strongly associated with RFS (HRs for stage IIIB, IIIC and IIID vs IIIA were 4.0, 5.7 and 12.2, respectively) but showed no predictive importance for the treatment comparison regarding RFS (test for interaction: P = 0.68). The 1-year RFS rate for pembrolizumab vs placebo and the HRs (99% confidence interval) within each AJCC-8 subgroup were as follows: stage IIIA (92.7% vs 92.5%; 0.76 [0.11-5.43]), IIIB (79.0% vs 65.5%; 0.59 [0.35-0.99]), IIIC (73.6% vs 53.9%; 0.48 [0.33-0.70]) and IIID (50.0% vs 33.3%; 0.69 [0.24-2.00]).
CONCLUSIONS


AJCC-8 staging had a strong prognostic importance for RFS but no predictive importance: the RFS benefit of pembrolizumab was observed across AJCC-8 subgroups in resected high-risk stage III melanoma patients.",2019,"AJCC-8 classification was strongly associated with RFS (HRs for stage IIIB, IIIC and IIID vs IIIA were 4.0, 5.7 and 12.2, respectively) but showed no predictive importance for the treatment comparison regarding RFS (test for interaction: P = 0.68).","['Cancer (EORTC', 'Patients (n\xa0', 'AJCC-7 stage', '1019', 'resected high-risk stage III melanoma']","['pembrolizumab vs placebo', 'pembrolizumab 200\xa0mg or placebo']","['pembrolizumab prolonged relapse-free survival (RFS', 'RFS (HRs for stage IIIB, IIIC\xa0and IIID vs IIIA', '1-year RFS rate']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0450318', 'cui_str': '1019'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",1019.0,0.585471,"AJCC-8 classification was strongly associated with RFS (HRs for stage IIIB, IIIC and IIID vs IIIA were 4.0, 5.7 and 12.2, respectively) but showed no predictive importance for the treatment comparison regarding RFS (test for interaction: P = 0.68).","[{'ForeName': 'Alexander M M', 'Initials': 'AMM', 'LastName': 'Eggermont', 'Affiliation': 'Gustave Roussy Cancer Campus Grand Paris, Villejuif, France. Electronic address: alexander.eggermont@gustaveroussy.fr.'}, {'ForeName': 'Christian U', 'Initials': 'CU', 'LastName': 'Blank', 'Affiliation': 'Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandala', 'Affiliation': 'Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, and Mater and Royal North Shore Hospitals, Sydney, NSW, Australia.'}, {'ForeName': 'Victoria G', 'Initials': 'VG', 'LastName': 'Atkinson', 'Affiliation': 'Princess Alexandra Hospital, Brisbane, QLD, Australia.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Dalle', 'Affiliation': 'Hospices Civils de Lyon Cancer Institute, Lyon, France.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haydon', 'Affiliation': 'Alfred Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Lichinitser', 'Affiliation': 'Russian Oncology Scientific Centre, Moscow, Russia.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Khattak', 'Affiliation': 'Fiona Stanley Hospital/University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Matteo S', 'Initials': 'MS', 'LastName': 'Carlino', 'Affiliation': 'Westmead and Blacktown Hospitals, Melanoma Institute Australia and the University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Shahneen', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Puig', 'Affiliation': 'Hospital Clinic Universitari de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS ""Fondazione G. Pascale"", Naples, Italy.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Maria Sklodowska-Curie Institute - Oncology Center, Warsaw, Poland.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Universitaetsklinikum - University Essen, Essen, Germany.'}, {'ForeName': 'Rutger', 'Initials': 'R', 'LastName': 'Koornstra', 'Affiliation': 'Radboud University Medical Center Nijmegen, Nijmegen, the Netherlands.'}, {'ForeName': 'Leonel', 'Initials': 'L', 'LastName': 'Hernandez-Aya', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Di Giacomo', 'Affiliation': 'Center for Immuno-Oncology, University Hospital of Siena, Siena, Italy.'}, {'ForeName': 'Alfonsus Jm', 'Initials': 'AJ', 'LastName': 'van den Eertwegh', 'Affiliation': 'Amsterdam University Medical Center, Location VUMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Aix Marseille University, Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Skin Cancer Center, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Rahima', 'Initials': 'R', 'LastName': 'Jamal', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal (CHUM), Centre de recherche du CHUM, Montreal, QC, Canada.""}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Lorigan', 'Affiliation': 'Christie NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lupinacci', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, United States.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Krepler', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, United States.'}, {'ForeName': 'Nageatte', 'Initials': 'N', 'LastName': 'Ibrahim', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, United States.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kicinski', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Marreaud', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'van Akkooi', 'Affiliation': 'Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy Cancer Campus Grand Paris, Villejuif, France.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.05.020']
2051,31320747,A head-to-head evaluation of the diagnostic efficacy and costs of trio versus singleton exome sequencing analysis.,"Diagnostic exome sequencing (ES) can be performed on the proband only (singleton; sES) or with additional samples, often including both biological parents with the proband (trio; tES). In this study we sought to compare the efficiencies of exome sequencing (ES) by trio (tES) versus singleton (sES) approach, determine costs, and identify factors to consider when deciding on optimal implementation strategies for the diagnosis of monogenic disorders. We undertook ES in 30 trios and analysed each proband's sES and tES data in parallel. Two teams were randomly allocated to either sES or tES analysis for each case and blinded to each other's work. Each task was timed and cost analyses were based on time taken and diagnostic yield. We modelled three scenarios to determine the factors to consider in the implementation of tES. sES diagnosed 11/30 (36.7%) cases and tES identified one additional diagnosis (12/30 (40.0%)). tES obviated the need for Sanger segregation, reduced the number of variants for curation, and had lower cost-per-diagnosis when considering analysis alone. When sequencing costs were included, tES nearly doubled the cost of sES. Reflexing to tES in those who remain undiagnosed after sES was cost-saving over tES in all as first-line. This approach requires a large differential in diagnostic yield between sES and tES for maximal benefit given current sequencing costs. tES may be preferable when scaling up laboratory throughput due to efficiency gains and opportunity cost considerations. Our findings are relevant to clinicians, laboratories and health services considering tES over sES.",2019,Reflexing to tES in those who remain undiagnosed after sES was cost-saving over tES in all as first-line.,"[""30 trios and analysed each proband's sES and tES data in parallel""]","['exome sequencing (ES) by trio (tES) versus singleton (sES) approach', 'Diagnostic exome sequencing (ES', 'sES or tES']",[],"[{'cui': 'C0702111', 'cui_str': 'Proband (finding)'}]","[{'cui': 'C3178814', 'cui_str': 'Exome'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}]",[],,0.0342913,Reflexing to tES in those who remain undiagnosed after sES was cost-saving over tES in all as first-line.,"[{'ForeName': 'Tiong Yang', 'Initials': 'TY', 'LastName': 'Tan', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia. tiong.tan@vcgs.org.au.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Lunke', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Chong', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Phelan', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Fanjul-Fernandez', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Justine E', 'Initials': 'JE', 'LastName': 'Marum', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Vanessa Siva', 'Initials': 'VS', 'LastName': 'Kumar', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Zornitza', 'Initials': 'Z', 'LastName': 'Stark', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Yeung', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Natasha J', 'Initials': 'NJ', 'LastName': 'Brown', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Stutterd', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Delatycki', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Sadedin', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Martyn', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, Australia.""}, {'ForeName': 'Ilias', 'Initials': 'I', 'LastName': 'Goranitis', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, Australia.""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Thorne', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, Australia.""}, {'ForeName': 'Clara L', 'Initials': 'CL', 'LastName': 'Gaff', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, Australia.""}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'White', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia. sue.white@vcgs.org.au.'}]",European journal of human genetics : EJHG,['10.1038/s41431-019-0471-9']
2052,31256141,Long-Term Impact of Intelligent Monitoring Technology on People with Cognitive Impairment: An Observational Study.,"BACKGROUND


Interactive smart home systems are particularly useful for people with cognitive impairment.
OBJECTIVE


To investigate the long-term effects of Assistive Technology (AT) combined with tailored non-pharmacological interventions for people with cognitive impairment.
METHODS


18 participants (12 with mild cognitive impairment and 6 with Alzheimer's disease) took part in the study that we evenly allocated in one of three groups: 1) experimental group (EG), 2) control group 1 (CG1), and 3) control group 2 (CG2). EG received the system installed at home for 4 to 12 months, during which they received tailored non-pharmacological interventions according to system observations. CG1 received tailored interventions for the same period, but only according to state-of-the-art self-reporting methods. Finally, CG2 neither had a system installation nor received interventions. All groups underwent neuropsychological assessment before and after the observational period.
RESULTS


After several months of continuously monitoring at home and deployment of tailored interventions, the EG showed statistically significant improvement in cognitive function, compared to the CG1 and CG2. Moreover, EG participants, who received the sensor-based system, have shown improvement in domains such as sleep quality and daily activity, as measured by the multi-sensor system. In addition, the feedback collected from the participants concludes that the long-term use of the multi-sensor system by people with cognitive impairment can be both feasible and beneficial.
CONCLUSION


Deploying a sensor-based system at real home settings of people with cognitive limitations living alone and maintaining its use long-term is not only possible, but also beneficial for clinical decision making in order to tackle cognitive, functional, and behavioral related problems.",2019,"After several months of continuously monitoring at home and deployment of tailored interventions, the EG showed statistically significant improvement in cognitive function, compared to the CG1 and CG2.","[""18 participants (12 with mild cognitive impairment and 6 with Alzheimer's disease) took part in the study that we evenly allocated in one of three groups: 1"", 'People with Cognitive Impairment', 'people with cognitive impairment']","['Intelligent Monitoring Technology', 'experimental group (EG), 2) control group 1 (CG1), and 3) CG2', 'Assistive Technology (AT) combined with tailored non-pharmacological interventions']","['cognitive function', 'sleep quality and daily activity']","[{'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036605', 'cui_str': 'Assistive Technology'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",18.0,0.0473567,"After several months of continuously monitoring at home and deployment of tailored interventions, the EG showed statistically significant improvement in cognitive function, compared to the CG1 and CG2.","[{'ForeName': 'Ioulietta', 'Initials': 'I', 'LastName': 'Lazarou', 'Affiliation': 'Information Technologies Institute, Center for Research and Technology Hellas (CERTH-ITI), Thessaloniki, Macedonia, Greece.'}, {'ForeName': 'Thanos G', 'Initials': 'TG', 'LastName': 'Stavropoulos', 'Affiliation': 'Information Technologies Institute, Center for Research and Technology Hellas (CERTH-ITI), Thessaloniki, Macedonia, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Meditskos', 'Affiliation': 'Information Technologies Institute, Center for Research and Technology Hellas (CERTH-ITI), Thessaloniki, Macedonia, Greece.'}, {'ForeName': 'Stelios', 'Initials': 'S', 'LastName': 'Andreadis', 'Affiliation': 'Information Technologies Institute, Center for Research and Technology Hellas (CERTH-ITI), Thessaloniki, Macedonia, Greece.'}, {'ForeName': 'Ioannis Yiannis', 'Initials': 'IY', 'LastName': 'Kompatsiaris', 'Affiliation': 'Information Technologies Institute, Center for Research and Technology Hellas (CERTH-ITI), Thessaloniki, Macedonia, Greece.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Tsolaki', 'Affiliation': 'Information Technologies Institute, Center for Research and Technology Hellas (CERTH-ITI), Thessaloniki, Macedonia, Greece.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190423']
2053,31891216,Ultrasound Diagnosis of Breast Lymphoma and the Identification of Breast Infiltrating Ductal Carcinoma.,"OBJECTIVES


By analyzing the B-mode ultrasound and color Doppler flow imaging characteristics of breast lymphoma (BL) and breast infiltrating ductal carcinoma (BIDC), we expected to discriminate these diseases.
METHODS


Thirty-two patients with BL and 30 with BIDC confirmed pathologically were selected. The BL group was divided into nodular and diffuse groups. We analyzed and compared the general and imaging characteristics of the BL subgroups and the BIDC group.
RESULTS


The mean maximum diameter of BL was 54.93 ± 43.74 cm, and that of BIDC was 23.90 ± 6.79 cm (P < .05). The differences between the nodular BL and BIDC groups in a circumscribed margin (60.00% versus 20.00%), calcification (20.00% versus 53.33%), aggregation characteristics (0.00% versus 53.33%), and density (73.33% versus 10.00%) were statistically significant (P < .05). The differences between the diffuse BL and BIDC groups in calcification (6.67% versus 53.33%), aggregation characteristics (6.67% versus 53.33%) and density (40.00% versus 10.00%) were statistically significant (P < .05). The difference in a circumscribed margin (60% versus 13.33%) between the BL subgroups was statistically significant (P < .05). The blood flow signal in BL lesions was richer than that in BIDC lesions (P < .05).
CONCLUSIONS


Extrasuperior-quadrant single lesions in the BL group were larger than those in the BIDC group. The edges of the lesions in the nodular BL group were circumscribed and dense. Lesions in the diffuse BL group did not have a circumscribed margin, calcification, aggregation characteristics, or density. The blood flow signal in BL lesions was richer than that in BIDC lesions.",2020,The difference in a circumscribed margin (60% versus 13.33%) between the BL subgroups was statistically significant (P < .05).,"['breast lymphoma (BL) and breast infiltrating ductal carcinoma (BIDC', 'Thirty-two patients with BL and 30 with BIDC confirmed pathologically were selected']",[],"['blood flow signal in BL lesions', 'aggregation characteristics', 'mean maximum diameter of BL', 'calcification']","[{'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0332448', 'cui_str': 'Tissue infiltration'}, {'cui': 'C1176475', 'cui_str': 'Ductal Carcinoma'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}]",[],"[{'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0332621', 'cui_str': 'Aggregation (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}]",32.0,0.0203419,The difference in a circumscribed margin (60% versus 13.33%) between the BL subgroups was statistically significant (P < .05).,"[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Ultrasound, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jie-Hong', 'Initials': 'JH', 'LastName': 'Zhou', 'Affiliation': 'Department of Ultrasound, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Hong-Xia', 'Initials': 'HX', 'LastName': 'Fan', 'Affiliation': 'Department of Ultrasound, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Ultrasound, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yu-Lan', 'Initials': 'YL', 'LastName': 'Peng', 'Affiliation': 'Department of Ultrasound, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Bu-Yun', 'Initials': 'BY', 'LastName': 'Ma', 'Affiliation': 'Department of Ultrasound, West China Hospital, Sichuan University, Chengdu, China.'}]",Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine,['10.1002/jum.15209']
2054,31102938,Immune function testing in sepsis patients receiving sodium selenite.,"PURPOSE


We examined in a longitudinal study the role of sodium selenite in sepsis patients in strengthening the immune performance in whole blood samples using immune functional assays.
MATERIALS AND METHODS


This was a sub-study from a randomized, double blinded multicenter clinical trial (SISPCT) registered with www.clinicaltrials.gov (NCT00832039) and with data collected at our center. Full blood samples were incubated with various recall antigens and the supernatants were measured for their cytokine concentrations as markers for immune response. Data from days 0, 4, 7, 14, and 21 (from sepsis onset) were analyzed using a generalized least squares model in R to appropriately take the longitudinal structure and the missing values into account.
RESULTS


From the 76 patients enrolled in the study at our center, 40 were randomized to selenium therapy and 36 to placebo. The analyses of immune response assay data showed no statistical difference between the selenium and placebo groups at each of the time points. There was however an overall dampening of cytokine release, which tended to recover over time in both groups.
CONCLUSION


Selenium has long been an adjuvant therapy in treating sepsis. Recently, it was proven to not have beneficial effects on the mortality outcome. Using data from our center in this sub-cohort study, we identified no relative improvement in cytokine release of stimulated blood immune cells ex vivo from patients with selenium therapy over a three-week period. This offers a potential explanation for the lack of beneficial effects of selenium in sepsis patients.",2019,The analyses of immune response assay data showed no statistical difference between the selenium and placebo groups at each of the time points.,"['76 patients enrolled in the study at our center, 40 were randomized to', 'sepsis patients', 'sepsis patients receiving']","['selenium and placebo', 'placebo', 'Selenium', 'sodium selenite', 'selenium therapy']",['cytokine release'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0142923', 'cui_str': 'Sodium Selenite'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]",76.0,0.177321,The analyses of immune response assay data showed no statistical difference between the selenium and placebo groups at each of the time points.,"[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Guo', 'Affiliation': 'Department of Anaesthesiology, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Jyotsna', 'Initials': 'J', 'LastName': 'Srinath', 'Affiliation': 'Institute for Medical Information Processing, Biometry and Epidemiology, LMU Munich, Munich, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Feuerecker', 'Affiliation': 'Department of Anaesthesiology, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Crucian', 'Affiliation': 'Johnson Space Center (JSC), NASA, 1601 NASA Parkway, Houston, TX 77058, USA.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Briegel', 'Affiliation': 'Department of Anaesthesiology, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Boulesteix', 'Affiliation': 'Institute for Medical Information Processing, Biometry and Epidemiology, LMU Munich, Munich, Germany.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Kaufmann', 'Affiliation': 'Department of Anaesthesiology, Munich-Neuperlach Hospital, Munich, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Choukèr', 'Affiliation': 'Department of Anaesthesiology, University Hospital, LMU Munich, Munich, Germany. Electronic address: achouker@med.uni-muenchen.de.'}]",Journal of critical care,['10.1016/j.jcrc.2019.05.001']
2055,31216205,Medical conditions at enrollment do not impact efficacy and safety of the adjuvanted recombinant zoster vaccine: a pooled post-hoc analysis of two parallel randomized trials.,"In two pivotal efficacy studies (ZOE-50; ZOE-70), the adjuvanted recombinant zoster vaccine (RZV) demonstrated >90% efficacy against herpes zoster (HZ).Adults aged ≥50 or ≥70 years (ZOE-50 [NCT01165177]; ZOE-70 [NCT01165229]) were randomized to receive 2 doses of RZV or placebo 2 months apart. Vaccine efficacy and safety were evaluated post-hoc in the pooled (ZOE-50/70) population according to the number and type of selected medical conditions present at enrollment.At enrollment, 82.3% of RZV and 82.7% of placebo recipients reported ≥1 of the 15 selected medical conditions. Efficacy against HZ ranged from 84.5% (95% Confidence Interval [CI]: 46.4-97.1) in participants with respiratory disorders to 97.0% (95%CI: 82.3-99.9) in those with coronary heart disease. Moreover, efficacy remained >90% irrespective of the number of selected medical conditions reported by a participant.As indicated by the similarity of the point estimates, this post-hoc analysis suggests that RZV efficacy remains high in all selected medical conditions, as well as with increasing number of medical conditions. No safety concern was identified by the type or number of medical conditions present at enrollment.",2019,Efficacy against HZ ranged from 84.5% (95% Confidence Interval [CI]: 46.4-97.1) in participants with respiratory disorders to 97.0% (95%CI: 82.3-99.9) in those with coronary heart disease.,['Adults aged ≥50 or ≥70\xa0years (ZOE-50 [NCT01165177]; ZOE-70 [NCT01165229'],"['RZV or placebo', 'recombinant zoster vaccine (RZV', 'placebo', 'ZOE-50; ZOE-70', 'recombinant zoster vaccine']","['Efficacy against HZ', 'Vaccine efficacy and safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.29684,Efficacy against HZ ranged from 84.5% (95% Confidence Interval [CI]: 46.4-97.1) in participants with respiratory disorders to 97.0% (95%CI: 82.3-99.9) in those with coronary heart disease.,"[{'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Oostvogels', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Heineman', 'Affiliation': 'GSK, King of Prussia, PA, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Johnson', 'Affiliation': 'Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Myron J', 'Initials': 'MJ', 'LastName': 'Levin', 'Affiliation': 'Departments of Pediatrics and Medicine, University of Colorado, Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Janet E', 'Initials': 'JE', 'LastName': 'McElhaney', 'Affiliation': 'Health Sciences North Research Institute, Sudbury, Ontario, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van den Steen', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Toufik', 'Initials': 'T', 'LastName': 'Zahaf', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Alemnew F', 'Initials': 'AF', 'LastName': 'Dagnew', 'Affiliation': 'GSK, Rockville, MD, USA.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Chlibek', 'Affiliation': 'Faculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Diez-Domingo', 'Affiliation': 'Fundación para el Fomento de la Investigación Sanitaria y Biomédica, Valencia, Spain.'}, {'ForeName': 'Iris S', 'Initials': 'IS', 'LastName': 'Gorfinkel', 'Affiliation': 'PrimeHealth Clinical Research, Toronto, Ontario, Canada.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hervé', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Shinn-Jang', 'Initials': 'SJ', 'LastName': 'Hwang', 'Affiliation': 'Department of Family Medicine, Taipei Veterans General Hospital and National Yang Ming University School of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Ikematsu', 'Affiliation': 'Japan Physicians Association, Tokyo, Japan.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Kalema', 'Affiliation': 'Keyrus Biopharma, Waterloo, Belgium, on behalf of GSK.'}, {'ForeName': 'Himal', 'Initials': 'H', 'LastName': 'Lal', 'Affiliation': 'GSK, King of Prussia, PA, USA.'}, {'ForeName': 'Shelly A', 'Initials': 'SA', 'LastName': 'McNeil', 'Affiliation': 'Canadian Center for Vaccinology, IWK Health Center and Nova Scotia Health Authority, Dalhousie, University, Halifax, Canada.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Mrkvan', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Karlis', 'Initials': 'K', 'LastName': 'Pauksens', 'Affiliation': 'Department of Infectious Diseases, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Smetana', 'Affiliation': 'Faculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Watanabe', 'Affiliation': 'Department of Dermatology, Aichi Medical University, Nagakute, Japan.'}, {'ForeName': 'Lily Yin', 'Initials': 'LY', 'LastName': 'Weckx', 'Affiliation': 'Department of Pediatrics, Federal University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Anthony L', 'Initials': 'AL', 'LastName': 'Cunningham', 'Affiliation': 'The Westmead Institute for Medical Research, Westmead, University of Sydney, Sydney, NSW, Australia.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1627818']
2056,31792646,"The influence of gender and oxytocin on stress reactivity, cigarette craving, and smoking in a randomized, placebo-controlled laboratory relapse paradigm.","RATIONALE


Female cigarette smokers tend to show greater cessation failure compared with males. Variables that contribute to the maintenance of smoking, including stress and craving, may differentially impact male and female smokers. Novel pharmacotherapies, such as oxytocin, may attenuate stress reactivity and craving in smokers, but work in this area is limited.
OBJECTIVES


This study assessed the influence of gender and oxytocin on stress reactivity, craving, and smoking in a randomized, placebo-controlled laboratory relapse paradigm.
METHODS


Male and female adult cigarette smokers (ages 18-45) were enrolled (women oversampled 2:1) and completed a laboratory session, in which intranasal oxytocin or placebo was administered followed by a laboratory social stress task. The role of gender and oxytocin were assessed on measures of stress reactivity, cigarette craving, latency to smoke in a resistance task, subjective responses to smoking, and ad-libitum smoking.
RESULTS


Participants (N = 144) had a mean age of 31 were 63% female and 56% White. Following stress induction, female smokers evidenced greater subjective stress than males, though males demonstrated greater neuroendocrine reactivity and smoking intensity than females. No gender differences were demonstrated for craving. Oxytocin did not attenuate any aspect of stress reactivity, craving, smoking, or subjective responses to smoking compared with placebo.
CONCLUSIONS


Gender differences in stress reactivity were shown in the hypothesized direction, but oxytocin appeared to exert little impact on subjective or behavioral metrics. Results highlight the complex relationship between gender, stress, and smoking, as well as the implications for oxytocin as a potential pharmacotherapy for smoking cessation.",2020,"Oxytocin did not attenuate any aspect of stress reactivity, craving, smoking, or subjective responses to smoking compared with placebo.
","['Female cigarette smokers', 'Participants (N = 144) had a mean age of 31 were 63% female and 56% White', 'Male and female adult cigarette smokers (ages 18-45) were enrolled (women oversampled 2:1) and completed a laboratory session, in which']","['placebo', 'intranasal oxytocin or placebo', 'oxytocin', 'Oxytocin']","['craving', 'stress reactivity, craving, and smoking', 'subjective stress', 'neuroendocrine reactivity and smoking intensity', 'stress reactivity, cigarette craving, latency to smoke in a resistance task, subjective responses to smoking, and ad-libitum smoking', 'stress reactivity, cigarette craving, and smoking', 'stress reactivity, craving, smoking, or subjective responses to smoking']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]",,0.0516614,"Oxytocin did not attenuate any aspect of stress reactivity, craving, smoking, or subjective responses to smoking compared with placebo.
","[{'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'McClure', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. mccluree@musc.edu.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Caitlyn O', 'Initials': 'CO', 'LastName': 'Hood', 'Affiliation': 'Department of Psychology, College of Arts & Sciences, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Tomko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Viswanathan R', 'Initials': 'VR', 'LastName': 'Ramakrishnan', 'Affiliation': 'Department of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Cole J', 'Initials': 'CJ', 'LastName': 'Buchanan', 'Affiliation': 'College of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Saladin', 'Affiliation': 'Department of Health Sciences and Research, College of Health Professions, Medical University of South Carolina, Charleston, SC, USA.'}]",Psychopharmacology,['10.1007/s00213-019-05392-z']
2057,31236874,Improvement in 6-min Walk Test Distance Following Treatment for Behavioral Weight Loss and Disinhibited Eating: an Exploratory Secondary Analysis.,"BACKGROUND


Poor functional exercise capacity is common among those with obesity; however, objective measures of exercise capacity are rarely examined in behavioral treatments targeting obese individuals. We examined whether a 4-week acceptance and commitment therapy (ACT) intervention for disinhibited eating or a behavioral weight loss (BWL) intervention improved exercise capacity and explored demographic and disinhibited eating variables related to exercise capacity.
METHODS


Veterans (n = 61), randomized to receive ACT or BWL, completed an assessment of exercise capacity via the 6-min walk test (6MWT) at baseline and 6-month follow-up. Measures of disinhibited eating patterns and body mass index (BMI), at baseline and post-treatment, were also collected. Change in 6MWT distance and treatment group differences were examined using mixed ANOVAs. Characteristics related to baseline 6MWT and predictors of improvement in 6MWT at 6 months were examined with hierarchical multiple regression.
RESULTS


There were overall significant improvements on the 6MWT from baseline to 6-month follow-up (F(1,59) = 11.14, p = .001, η p 2  = .159) but no differences between the ACT and BWL groups. Baseline BMI (β = - .33, p = .005) was the only variable related to baseline 6MWT. Improvements on the 6MWT were related to younger age (β = - .41, p = 0.001), female gender (β = .36, p = .001), and treatment-related increases in dietary restraint behaviors (β = .42, p = .001).
CONCLUSIONS


Functional exercise capacity improved among participants completing behavioral interventions for weight and disinhibited eating. Improvements in dietary behavior regulatory skills may have generalized to improved regulation in other behavioral domains associated with exercise capacity.",2019,Improvements on the 6MWT were related to younger age (β ,"['Veterans (n\u2009=\u200961', 'participants completing behavioral interventions for weight and disinhibited eating']","['ACT or BWL, completed an assessment of exercise capacity via the 6-min walk test (6MWT', '4-week acceptance and commitment therapy (ACT) intervention for disinhibited eating or a behavioral weight loss (BWL) intervention']","['Baseline BMI', 'Behavioral Weight Loss and Disinhibited Eating', 'disinhibited eating patterns and body mass index (BMI', '6MWT', 'female gender (β', 'dietary restraint behaviors (β\u2009']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0492712,Improvements on the 6MWT were related to younger age (β ,"[{'ForeName': 'Jennalee S', 'Initials': 'JS', 'LastName': 'Wooldridge', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Herbert', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Hernandez', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Dochat', 'Affiliation': 'San Diego State University/University of California, San Diego Joint Doctoral Program in Clinical Psychology, San Diego, CA, USA.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Godfrey', 'Affiliation': 'Center for Weight, Eating and Lifestyle Science (WELL Center), Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Gasperi', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, CA, USA.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Afari', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA. nafari@ucsd.edu.'}]",International journal of behavioral medicine,['10.1007/s12529-019-09796-1']
2058,31227286,Independent serum markers of corpora lutea function after gonadotropin-releasing hormone agonist trigger and adjuvant low dose human chorionic gonadotropin in in vitro fertilization.,"OBJECTIVE


To characterize corpora lutea (CL) function after gonadotropin-releasing hormone agonist (GnRHa) trigger with the use of adjuvant human chorionic gonadotropin (hCG).
DESIGN


Secondary analysis of serum from prospective randomized clinical trial.
SETTING


University-based fertility center.
PATIENT(S)


Women under 40 years of age at risk of ovarian hyperstimulation syndrome (OHSS) with serum E 2  level <4,000 pg/mL.
INTERVENTIONS(S)


All subjects underwent ovarian stimulation with the use of a GnRH antagonist protocol. Within a larger study, subjects were randomized to receive 1,000 IU hCG at the time of GnRHa trigger and placebo at the time of vaginal oocyte retrieval (VOR) or placebo at the time of GnRHa trigger and 1,500 IU hCG at the time of VOR.
MAIN OUTCOME MEASURE(S)


Luteal phase and early pregnancy curves of serum prorenin and 17α-hydroxyprogesterone (17OH-P).
RESULT(S)


Thirty subjects enrolled in this secondary analysis. Serum 17OH-P peaked in the early luteal phase, 5 days after GnRHa trigger, with a nadir in the mid-luteal phase 9 days after trigger. Serum prorenin peaked in the luteal phase 2 days after GnRHa trigger, independently from adjuvant hCG timing, and reached a nadir at 9 days after trigger. CL function appears higher when adjuvant hCG is given at VOR compared with adjuvant hCG given at the time of trigger.
CONCLUSION(S)


CL function, as interpreted by proxy measures of serum prorenin and 17OH-P with pregnancy, continues despite GnRHa trigger. Both options for adjuvant hCG timing are sufficient for CL rescue and successful pregnancy, so the potential for OHSS risk with increased CL activity after hCG at VOR should be considered.
CLINICAL TRIAL REGISTRATION NUMBER


NCT01815138.",2019,Women under 40 years of age at risk of ovarian hyperstimulation syndrome (OHSS) with serum E 2  level,"['Women under 40\xa0years of age at risk of ovarian hyperstimulation syndrome (OHSS) with serum E 2  level', '\n\n\nThirty subjects enrolled in this secondary analysis', 'University-based fertility center']","['adjuvant human chorionic gonadotropin (hCG', 'GnRH antagonist protocol', 'placebo', 'hCG', 'gonadotropin-releasing hormone agonist trigger and adjuvant low dose human chorionic gonadotropin', 'gonadotropin-releasing hormone agonist (GnRHa', 'adjuvant hCG']","['CL function', 'Serum prorenin', 'Serum 17OH-P', 'Luteal phase and early pregnancy curves of serum prorenin and 17α-hydroxyprogesterone (17OH-P', 'CL activity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0085083', 'cui_str': 'Ovarian Hyperstimulation Syndrome'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement (procedure)'}, {'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0072249', 'cui_str': 'Big Renin'}, {'cui': 'C0024153', 'cui_str': 'Postovulatory Phase'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0045010', 'cui_str': '17-alpha-Hydroxyprogesterone'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",30.0,0.0889825,Women under 40 years of age at risk of ovarian hyperstimulation syndrome (OHSS) with serum E 2  level,"[{'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Kaye', 'Affiliation': 'Fertility Center of Las Vegas, Las Vegas, Nevada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Griffin', 'Affiliation': ""Boston IVF at The Women's Hospital, Newburgh, Indiana.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Thorne', 'Affiliation': 'Center for Advanced Reproductive Services, Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Connecticut School of Medicine, Farmington, Connecticut.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Neuber', 'Affiliation': 'Center for Advanced Reproductive Services, Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Connecticut School of Medicine, Farmington, Connecticut.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nulsen', 'Affiliation': 'Center for Advanced Reproductive Services, Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Connecticut School of Medicine, Farmington, Connecticut.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Benadiva', 'Affiliation': 'Center for Advanced Reproductive Services, Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Connecticut School of Medicine, Farmington, Connecticut.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Engmann', 'Affiliation': 'Center for Advanced Reproductive Services, Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Connecticut School of Medicine, Farmington, Connecticut. Electronic address: lengmann@uchc.edu.'}]",Fertility and sterility,['10.1016/j.fertnstert.2019.04.034']
2059,30399122,A Randomized Controlled Trial of Naloxone for Optimization of Hypoxemia in Lung Donors After Brain Death.,"BACKGROUND


Persistent hypoxemia is the principal reason lungs from otherwise eligible brain dead (BD) organ donors are not transplanted. Experimental models and retrospective studies have suggested that naloxone attenuates neurogenic pulmonary edema and reverses hypoxemia after brain death. We undertook a multisite, randomized, placebo-controlled trial to evaluate whether naloxone is able to improve oxygenation in BD donors with hypoxemia.
METHODS


BD organ donors at 4 organ procurement organizations were randomized in a blinded manner to naloxone 8 mg or saline placebo if lung were being considered for allocation but exhibited hypoxemia (partial pressure of oxygen in arterial blood to fraction of inspired oxygen ratio [PFR] below 300 mm Hg). The primary outcome was change in PFR from baseline to final arterial blood gas. Secondary outcomes included early improvement in PFR and proportion of lungs transplanted.
RESULTS


A total of 199 lung-eligible BD donors were randomized to naloxone (n = 98) or placebo (n = 101). Groups were comparable at baseline. Both groups exhibited similar improvements in oxygenation (median improvement in PFR of 81 with naloxone versus 80 with saline, P = 0.68), with 37 (39%) versus 38 (40%) exhibiting reversal of hypoxemia. There was no difference in the rate of lungs transplanted (19% in both groups, P = 0.97) although it was significantly higher in those with reversal of hypoxemia (32/69 versus 2/111, P < 0.001).
CONCLUSIONS


Naloxone does not improve oxygenation more than placebo in hypoxemic organ donors. However, reversal of hypoxemia was a powerful predictor of lung utilization regardless of drug therapy. Further organ procurement organization-led research is needed to assess optimal interventions to improve oxygenation in BD donors with hypoxemia.",2019,"There was no difference in the rate of lungs transplanted (19% in both groups, P = 0.97) although it was significantly higher in those with reversal of hypoxemia (32/69 versus 2/111, P < 0.001).
","['hypoxemic organ donors', '199 lung-eligible BD donors', 'BD donors with hypoxemia', 'Lung Donors', 'BD organ donors at 4 organ procurement organizations']","['naloxone', 'Naloxone', 'naloxone 8 mg or saline placebo', 'placebo']","['change in PFR from baseline to final arterial blood gas', 'exhibiting reversal of hypoxemia', 'reversal of hypoxemia', 'oxygenation', 'rate of lungs transplanted', 'PFR and proportion of lungs transplanted']","[{'cui': 'C0029206', 'cui_str': 'Organ donor (person)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0524360', 'cui_str': 'Donor for lung transplant (person)'}, {'cui': 'C0029210', 'cui_str': 'Organ Procurement'}, {'cui': 'C0220885', 'cui_str': 'organization'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030735', 'cui_str': 'PEFR'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0024128', 'cui_str': 'Grafting, Lung'}]",,0.517867,"There was no difference in the rate of lungs transplanted (19% in both groups, P = 0.97) although it was significantly higher in those with reversal of hypoxemia (32/69 versus 2/111, P < 0.001).
","[{'ForeName': 'Rajat', 'Initials': 'R', 'LastName': 'Dhar', 'Affiliation': 'Division of Neurocritical Care, Department of Neurology, Washington University in St. Louis School of Medicine, St. Louis, MO.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Stahlschmidt', 'Affiliation': 'Mid-America Transplant, St. Louis, MO.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Paramesh', 'Affiliation': 'Department of Surgery, Tulane University School of Medicine, New Orleans, LA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Marklin', 'Affiliation': 'Mid-America Transplant, St. Louis, MO.'}]",Transplantation,['10.1097/TP.0000000000002511']
2060,30587296,"Pay-it-forward strategy to enhance uptake of dual gonorrhea and chlamydia testing among men who have sex with men in China: a pragmatic, quasi-experimental study.","BACKGROUND


Chinese men who have sex with men (MSM) rarely receive gonorrhoea and chlamydia testing. The purpose of this pilot study was to evaluate a pay-it-forward strategy to increase uptake of gonorrhoea and chlamydia testing among MSM.
METHODS


We performed a quasi-experimental pragmatic study to compare a pay-it-forward model with standard of care at two HIV testing sites for MSM in Guangzhou, China: an STD clinic for MSM and a local MSM community-based organisation. All men who arrived at the STD clinic or the community-based organisation were invited to participate. In the pay-it-forward programme, men were offered free gonorrhoea and chlamydia testing and given the option of donating money toward testing for future participants. In the standard-of-care group, men were offered gonorrhoea and chlamydia testing at the standard patient price of ¥150 (about US$21·50). The pay-it-forward programme was implemented for 3 months, after which both sites switched to standard of care offering dual testing for 3 months. The primary outcome for this study was uptake of dual gonorrhoea and chlamydia testing, which we compared using χ 2  test and logistic regression, reported as crude odds ratios (cOR) and adjusted odds ratios (aOR), by adjusting for nationality, marital status, income, and site of testing.
FINDINGS


The pay-it-forward programme took place from Dec 2, 2017, to Feb 3, 2018, and the standard-of-care control took place from March 11, 2018, to May 1, 2018. 408 men were included in this study. 203 men were offered pay-it-forward, and 205 were offered standard of care. Overall, 109 (54%) of 203 men in the pay-it-forward group and 12 (6%) of 205 men in the standard-of-care group received gonorrhoea and chlamydia testing (cOR 18·65, 9·78-35·54; p<0·0001; aOR 19·73, 95% CI 10·02-38·85; p<0·0001). Of all 121 men who tested, this was the first gonorrhoea test for 97 (80%) men and the first chlamydia test for 104 (86%) men. Five (4%) of these 121 men were diagnosed with gonorrhoea and 15 (12%) were diagnosed with chlamydia. 97 (89%) of 109 men who received testing in the pay-it-forward group donated some money toward testing for future participants.
INTERPRETATION


Pay-it-forward might be a sustainable model for expanding integrated HIV testing services among MSM in China.
FUNDING


National Institutes of Health, Southern Medical University Dermatology Hospital, Doris Duke Charitable Foundation.",2019,"Of all 121 men who tested, this was the first gonorrhoea test for 97 (80%) men and the first chlamydia test for 104 (86%) men.","['408 men', 'men who have sex with men in China', '121 men who tested, this was the first gonorrhoea test for 97 (80%) men and the first chlamydia test for 104 (86%) men', '203 men were offered pay-it-forward, and 205 were offered standard of care', 'Chinese men who have sex with men (MSM) rarely receive gonorrhoea and chlamydia testing', '97 (89%) of 109 men who received testing in the pay-it-forward group donated some money toward testing for future participants', 'All men who arrived at the STD clinic or the community-based organisation were invited to participate', '121 men were diagnosed with gonorrhoea and 15 (12%) were diagnosed with chlamydia']",[],"['gonorrhoea and chlamydia testing', 'uptake of dual gonorrhoea and chlamydia testing', 'crude odds ratios (cOR) and adjusted odds ratios (aOR), by adjusting for nationality, marital status, income, and site of testing']","[{'cui': 'C4517769', 'cui_str': 'Four hundred and eight'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C0851178'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0522498', 'cui_str': 'Uncommon (qualifier value)'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3540770', 'cui_str': 'Existential restriction modifier'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}]",[],"[{'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0027473', 'cui_str': 'Nationality'}, {'cui': 'C0024819', 'cui_str': 'Marital Status'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C2945843', 'cui_str': 'Site of (attribute)'}]",203.0,0.0290343,"Of all 121 men who tested, this was the first gonorrhoea test for 97 (80%) men and the first chlamydia test for 104 (86%) men.","[{'ForeName': 'Katherine T', 'Initials': 'KT', 'LastName': 'Li', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA; University of North Carolina Project-China, Guangzhou, China; SESH (Social Entrepreneurship to Spur Health) Team, Guangzhou, China.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China; SESH (Social Entrepreneurship to Spur Health) Team, Guangzhou, China; Dermatology Hospital, Southern Medical University, Guangzhou, China; School of Public Health, Southern Medical University, Guangzhou, China; University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China; SESH (Social Entrepreneurship to Spur Health) Team, Guangzhou, China.'}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China; SESH (Social Entrepreneurship to Spur Health) Team, Guangzhou, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China; SESH (Social Entrepreneurship to Spur Health) Team, Guangzhou, China; Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China; SESH (Social Entrepreneurship to Spur Health) Team, Guangzhou, China.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Feng', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China; SESH (Social Entrepreneurship to Spur Health) Team, Guangzhou, China; Duke University, Durham, NC, USA.'}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Pan', 'Affiliation': ""Xi'an Jiaotong-Liverpool University, Suzhou, China.""}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China; SESH (Social Entrepreneurship to Spur Health) Team, Guangzhou, China; University of Cambridge Judge Business School, Cambridge, UK.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Mak', 'Affiliation': 'University of Cambridge Judge Business School, Cambridge, UK.'}, {'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Dermatology Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'SESH (Social Entrepreneurship to Spur Health) Team, Guangzhou, China; University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK. Electronic address: jdtucker@med.unc.edu.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30556-5']
2061,30240280,Improving image quality with model-based iterative reconstruction at quarter of nominal dose in upper abdominal CT.,"OBJECTIVE


To evaluate the ability of a model-based iterative reconstruction (MBIR) for improving image quality in upper abdominal CT with quarter of the normal dose, in comparison with adaptive statistical iterative reconstruction (ASiR) at normal dose.
METHODS


40 upper abdominal patients were randomly divided into two groups: normal-dose group ( n  = 20) with tube current modulation for noise index (NI) of 10 HU and 40% ASiR reconstruction; low-dose group ( n  = 20) with NI = 20  HU in the delay phase and MBIR and 40%ASiR. Images in the delay phase were compared. The CT values and standard deviation (SD) values of the liver, spleen, pancreas, kidney, erector spine and fat were measured. Contrast-noise-ratio (CNR = (CT tissue -CT  fat )/SD fat ) of each measured organ were calculated and compared with one-way ANOVA among the three reconstruction groups. The subjective image scores of the three groups were assessed blindly by two experienced physicians using a 5-point system and the score consistency was compared by the κ test.
RESULTS


Dose reduction of 75 % was achieved for the low-dose scan. The subjective scores (95 % confidence intervals) of the three groups (NI 10-40 %  ASiR, NI 20-40%  ASiR and NI 20-MBIR) were 4.00 ± 0.79 (3.62-4.37), 3.35 ± 0.58 (3.07-3.62) and 3.90 ± 0.64 (3.60-4.19), respectively with no difference between the NI 10-40%  ASiR and NI20-MBIR groups and good consistency between reviewers (κ = 0.726). MBIR had statistically lower SD values and higher contrast-to-noise ratio values in the liver, spleen, pancreas, kidney and erector spine than NI 10-40%  ASiR and NI 20-40%  ASiR (all  p  < 0.05).
CONCLUSION


At 75 % dose reduction, MBIR provides similar image quality compared to 40% ASiR at normal-dose.
ADVANCES IN KNOWLEDGE


MBIR provides good image quality at 25 % of the normal dose.",2019,"MBIR had statistically lower SD values and higher contrast-to-noise ratio values in the liver, spleen, pancreas, kidney and erector spine than NI 10-40%  ASiR and NI 20-40%  ASiR (all p < 0.05).
",['\n\n\n40 upper abdominal patients'],"['adaptive statistical iterative reconstruction (ASiR', 'CT tissue -CT  fat ', 'SD', 'model-based iterative reconstruction (MBIR', 'normal-dose group (n = 20) with tube current modulation for noise index (NI) of 10 HU and 40% ASiR reconstruction; low-dose group']","['subjective scores', 'CT values and standard deviation (SD) values of the liver, spleen, pancreas, kidney, erector spine and fat', 'SD values', 'subjective image scores']","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0037993', 'cui_str': 'Spleen'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]",20.0,0.019799,"MBIR had statistically lower SD values and higher contrast-to-noise ratio values in the liver, spleen, pancreas, kidney and erector spine than NI 10-40%  ASiR and NI 20-40%  ASiR (all p < 0.05).
","[{'ForeName': 'Xirong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Techniques, Shaanxi University of Chinese medicine, Xianyang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Affiliated Hospital of Shaanxi University of Chinese medicine, Xianyang, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Yu', 'Affiliation': 'Department of Radiology, Affiliated Hospital of Shaanxi University of Chinese medicine, Xianyang, China.'}, {'ForeName': 'Zhanli', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': 'Department of Radiology, Affiliated Hospital of Shaanxi University of Chinese medicine, Xianyang, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Tian', 'Affiliation': 'Department of Radiology, Affiliated Hospital of Shaanxi University of Chinese medicine, Xianyang, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Tian', 'Affiliation': 'Department of Radiology, Affiliated Hospital of Shaanxi University of Chinese medicine, Xianyang, China.'}, {'ForeName': 'Taiping', 'Initials': 'T', 'LastName': 'He', 'Affiliation': 'Department of Radiology, Affiliated Hospital of Shaanxi University of Chinese medicine, Xianyang, China.'}, {'ForeName': 'Changyi', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': 'Department of Radiology, The Second Affiliated Hospital of Shaanxi University of Chinese medicine, Xianyang, China.'}]",The British journal of radiology,['10.1259/bjr.20180137']
2062,30070379,Mailed Outreach Invitations Significantly Improve HCC Surveillance Rates in Patients With Cirrhosis: A Randomized Clinical Trial.,"Hepatocellular carcinoma (HCC) surveillance is associated with early tumor detection and improved survival in patients with cirrhosis; however, effectiveness is limited by underuse. We compared the effectiveness of mailed outreach and patient navigation strategies to increase HCC surveillance in a racially diverse cohort of patients with cirrhosis. We conducted a pragmatic randomized clinical trial comparing mailed outreach for screening ultrasound (n = 600), mailed outreach plus patient navigation (n = 600), or usual care with visit-based screening (n = 600) among 1800 patients with cirrhosis at a large safety-net health system from December 2014 to March 2017. Patients who did not respond to outreach invitations within 2 weeks received reminder telephone calls. Patient navigation included an assessment of barriers to surveillance and encouragement of surveillance participation. The primary outcome was HCC surveillance (abdominal imaging every 6 months) over an 18-month period. All 1800 patients were included in intention-to-screen analyses. HCC surveillance was performed in 23.3% of outreach/navigation patients, 17.8% of outreach-alone patients, and 7.3% of usual care patients. HCC surveillance was 16.0% (95% confidence interval [CI]: 12.0%-20.0%) and 10.5% (95% CI: 6.8%-14.2%) higher in outreach groups than usual care (P < 0.001 for both) and 5.5% (95% CI: 0.9%-10.1%) higher for outreach/navigation than outreach alone (P = 0.02). Both interventions increased HCC surveillance across predefined patient subgroups. The proportion of HCC patients detected at an early stage did not differ between groups; however, a higher proportion of patients with screen-detected HCC across groups had early-stage tumors than those with HCC detected incidentally or symptomatically (83.3% versus 30.8%, P = 0.003). Conclusion: Mailed outreach invitations and navigation significantly increased HCC surveillance versus usual care in patients with cirrhosis.",2019,"HCC surveillance was performed in 23.3% of outreach/navigation patients, 17.8% of outreach-alone patients, and 7.3% of usual care patients.","['Patients who did not respond to outreach invitations within 2 weeks received', 'Patients With Cirrhosis', '1800 patients with cirrhosis at a large safety-net health system from December 2014 to March 2017', 'All 1800 patients were included in intention-to-screen analyses', 'racially diverse cohort of patients with cirrhosis', 'patients with cirrhosis']","['mailed outreach and patient navigation strategies', 'Mailed outreach invitations and navigation significantly increased HCC surveillance', 'Mailed Outreach Invitations', 'reminder telephone calls', 'mailed outreach for screening ultrasound (n = 600), mailed outreach plus patient navigation (n = 600), or usual care with visit-based screening']","['HCC Surveillance Rates', 'HCC surveillance (abdominal imaging every 6 months', 'HCC surveillance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0585339', 'cui_str': 'q6mo'}]",1800.0,0.145219,"HCC surveillance was performed in 23.3% of outreach/navigation patients, 17.8% of outreach-alone patients, and 7.3% of usual care patients.","[{'ForeName': 'Amit G', 'Initials': 'AG', 'LastName': 'Singal', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Jasmin A', 'Initials': 'JA', 'LastName': 'Tiro', 'Affiliation': 'Department of Clinical Sciences, The University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Caitlin C', 'Initials': 'CC', 'LastName': 'Murphy', 'Affiliation': 'Department of Clinical Sciences, The University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Marrero', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'McCallister', 'Affiliation': 'Department of Clinical Sciences, The University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Fullington', 'Affiliation': 'Department of Clinical Sciences, The University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Mejias', 'Affiliation': 'Department of Clinical Sciences, The University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Akbar K', 'Initials': 'AK', 'LastName': 'Waljee', 'Affiliation': 'Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Pechero Bishop', 'Affiliation': 'Department of Clinical Sciences, The University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Noel O', 'Initials': 'NO', 'LastName': 'Santini', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Ethan A', 'Initials': 'EA', 'LastName': 'Halm', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, Texas.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30129']
2063,30655090,"Reductions in 30-day readmission, mortality, and costs with inpatient-to-community pharmacist follow-up.","OBJECTIVES


To determine the impact of pharmacist-provided continuous care and electronic communication on readmissions among a group of high-risk patients.
DESIGN


Pragmatic interventional study with 5:1 matched control.
SETTING AND PARTICIPANTS


Patients discharged from any of 4 hospitals with chronic obstructive pulmonary disease, pneumonia, heart failure, acute myocardial infarction, or diabetes within Pennsylvania. Patients in the intervention group received consultative services from inpatient pharmacists before discharge and inpatient-to-community pharmacist communication of hospitalization information facilitated with the use of a secure messaging system. After discharge, patients received up to 5 in-person or telephonic medication management consultations with their community pharmacists.
MAIN OUTCOME MEASURES


The principal end point was 30-day readmission. Secondary end points included time to event (readmission, emergency department [ED] visit, death, or composite of hospitalization, ED, or death) over 90 days after discharge. Financial feasibility and sustainability were also assessed with the use of a return-on-investment (ROI) model based on information within the subset of patients with health plan coverage.
RESULTS


Among patients who received inpatient intervention plus consultation with community pharmacists compared with matched control patients, we observed a lower 30-day readmission rate (9% vs. 15%, respectively; P = 0.02), 30-day all-cause mortality (2% vs. 5%; P = 0.04), and composite 30-day end point of readmission, ED visit, or death (22% vs. 28%; P = 0.09). Differences between the groups diminished and no longer maintained statistical significance at 90 days. An estimated average ROI of 8.1 was also observed among the subset with health plan information (worst base case range 1.9-16.3).
CONCLUSION


Connecting community pharmacists to inpatient pharmacists during the transitional hospital-to-home time frame is feasible and resulted in lower 30-day readmissions and significant ROI, that is, significant impact on health care utilization and total health care costs. Results of this study have broad implications for improving the care of high-risk patients moving from hospital to home, most notably in the engagement of community pharmacists after discharge to assure medication use and follow-up to reduce readmissions and total costs of care.",2019,Differences between the groups diminished and no longer maintained statistical significance at 90 days.,"['Patients discharged from any of 4 hospitals with chronic obstructive pulmonary disease, pneumonia, heart failure, acute myocardial infarction, or diabetes within Pennsylvania', 'readmissions among a group of high-risk patients']","['consultative services from inpatient pharmacists before discharge and inpatient-to-community pharmacist communication of hospitalization information facilitated with the use of a secure messaging system', 'pharmacist-provided continuous care and electronic communication', 'telephonic medication management consultations with their community pharmacists']","['Financial feasibility and sustainability', '30-day readmission, mortality, and costs with inpatient-to-community pharmacist follow-up', 'composite 30-day end point of readmission, ED visit, or death', '30-day readmission rate', 'time to event (readmission, emergency department [ED] visit, death, or composite of hospitalization, ED, or death', '30-day all-cause mortality', '30-day readmission']","[{'cui': 'C0030685', 'cui_str': 'Patient Discharge'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0402003', 'cui_str': 'Community Pharmacists'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0402003', 'cui_str': 'Community Pharmacists'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]",,0.0715398,Differences between the groups diminished and no longer maintained statistical significance at 90 days.,"[{'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Wright', 'Affiliation': ''}, {'ForeName': 'Jove H', 'Initials': 'JH', 'LastName': 'Graham', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Maeng', 'Affiliation': ''}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Tusing', 'Affiliation': ''}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Zaleski', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Seipp', 'Affiliation': ''}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Citsay', 'Affiliation': ''}, {'ForeName': 'Bette', 'Initials': 'B', 'LastName': 'McDonald', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Bolesta', 'Affiliation': ''}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Chaundy', 'Affiliation': ''}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Medico', 'Affiliation': ''}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Gunderman', 'Affiliation': ''}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Leri', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Guza', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Price', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Gregor', 'Affiliation': ''}, {'ForeName': 'Dean T', 'Initials': 'DT', 'LastName': 'Parry', 'Affiliation': ''}]",Journal of the American Pharmacists Association : JAPhA,['10.1016/j.japh.2018.11.005']
2064,31904445,Outcomes of a church-based lifestyle intervention among Australian Samoans in Sydney - Le Taeao Afua diabetes prevention program.,"AIMS


To evaluate the effectiveness of a culturally adapted, church-based lifestyle intervention among Australian Samoans living in Sydney.
METHODS


This was a prospective, pre-post study of a church-wide education and support programme delivered by Community Coach Facilitators and Peer Support Facilitators to prevent, and promote self-management of, Type 2 diabetes. Participants completed questionnaires, anthropometric and HbA1c measurements before and 3-8 months after the intervention. The primary outcome was HbA1c.
RESULTS


Overall, 68/107(63.5%) participants completed both before and after intervention data collection (mean age 48.9 ± 14.2 years; 57.2% female). HbA1c dropped significantly between baseline and follow-up among participants with known diabetes (8.1 ± 2.4% (65 mmol/mol) vs 7.4 ± 1.8% (57 mmol/mol); p = 0.040) and non-significantly among participants with newly diagnosed diabetes (8.0 ± 2.1% (64 mmol/mol) vs 7.1 ± 2.3 (54 mmol/mol); p = 0.131). Participants with no diabetes increased their weekly moderate and vigorous physical activity (316.1 ± 291.6mins vs 562.4 ± 486.6mins; p = 0.007) and their diabetes knowledge also improved post-intervention (42.0 ± 13.5% to 61.3 ± 20.2%; p < 0.001). There were no significant reductions in blood pressure, BMI or waist circumference at follow-up.
CONCLUSIONS


A structured, church-based, culturally tailored lifestyle intervention showed a number of improvements in diabetes risk among Samoans in Sydney. The intervention however, requires a more rigorous testing in a larger randomised controlled trial over a longer time period.",2020,"There were no significant reductions in blood pressure, BMI or waist circumference at follow-up.
","['Australian Samoans in Sydney', 'Australian Samoans living in Sydney']","['church-wide education and support programme delivered by Community Coach Facilitators and Peer Support Facilitators', 'church-based lifestyle intervention', 'culturally adapted, church-based lifestyle intervention']","['diabetes risk', 'weekly moderate and vigorous physical activity', 'blood pressure, BMI or waist circumference', 'HbA1c', 'diabetes knowledge']",[],"[{'cui': 'C0562324', 'cui_str': 'Church (environment)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0901089,"There were no significant reductions in blood pressure, BMI or waist circumference at follow-up.
","[{'ForeName': 'Dorothy W', 'Initials': 'DW', 'LastName': 'Ndwiga', 'Affiliation': 'School of Science and Health, Western Sydney University, Australia.'}, {'ForeName': 'Freya', 'Initials': 'F', 'LastName': 'MacMillan', 'Affiliation': 'School of Science and Health, Western Sydney University, Australia; Diabetes Obesity Metabolism Translational Research Unit, Western Sydney University, Australia; Translational Health Research Institute, Western Sydney University, Australia.'}, {'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'McBride', 'Affiliation': 'Diabetes Obesity Metabolism Translational Research Unit, Western Sydney University, Australia; Translational Health Research Institute, Western Sydney University, Australia; School of Medicine, Western Sydney University, Australia.'}, {'ForeName': 'Ronda', 'Initials': 'R', 'LastName': 'Thompson', 'Affiliation': 'School of Medicine, Western Sydney University, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Reath', 'Affiliation': 'School of Medicine, Western Sydney University, Australia.'}, {'ForeName': 'Olataga', 'Initials': 'O', 'LastName': 'Alofivae-Doorbinia', 'Affiliation': 'Powell Street Medical and Dental Practice, Yagoona, Australia.'}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Abbott', 'Affiliation': 'School of Medicine, Western Sydney University, Australia.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'McCafferty', 'Affiliation': 'School of Medicine, Western Sydney University, Australia.'}, {'ForeName': 'Marra', 'Initials': 'M', 'LastName': 'Aghajani', 'Affiliation': 'School of Medicine, Western Sydney University, Australia.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Rush', 'Affiliation': 'Faculty of Health and Environmental Science, Auckland University of Technology, New Zealand.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simmons', 'Affiliation': 'Diabetes Obesity Metabolism Translational Research Unit, Western Sydney University, Australia; Translational Health Research Institute, Western Sydney University, Australia; School of Medicine, Western Sydney University, Australia. Electronic address: da.simmons@westernsydney.edu.au.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108000']
2065,31799782,"Effect of Liraglutide on Cardiovascular Function and Myocardial Tissue Characteristics in Type 2 Diabetes Patients of South Asian Descent Living in the Netherlands: A Double-Blind, Randomized, Placebo-Controlled Trial.","BACKGROUND


The glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide may be beneficial in the regression of diabetic cardiomyopathy. South Asian ethnic groups in particular are at risk of developing type 2 diabetes.
PURPOSE


To assess the effects of liraglutide on left ventricular (LV) diastolic and systolic function in South Asian type 2 diabetes patients.
STUDY TYPE


Prospective, double-blind, randomized, placebo-controlled trial.
POPULATION


Forty-seven type 2 diabetes patients of South Asian ancestry living in the Netherlands, with or without ischemic heart disease, who were randomly assigned to 26-week treatment with liraglutide (1.8 mg/day) or placebo.
FIELD STRENGTH/SEQUENCE


3T (balanced steady-state free precession cine MRI, 2D and 4D velocity-encoded MRI,  1  H-MRS, T 1  mapping).
ASSESSMENT


Primary endpoints were changes in LV diastolic function (early deceleration peak [Edec], ratio of early and late peak filling rate [E/A], estimated LV filling pressure [E/Ea]) and LV systolic function (ejection fraction). Secondary endpoints were changes in aortic stiffness (aortic pulse wave velocity [PWV]), myocardial steatosis (myocardial triglyceride content), and diffuse fibrosis (extracellular volume [ECV]).
STATISTICAL TESTS


Data were analyzed according to intention-to-treat. Between-group differences were reported as mean (95% confidence interval [CI]) and were assessed using analysis of covariance (ANCOVA).
RESULTS


Liraglutide (n = 22) compared with placebo (n = 25) did not change Edec (+0.2 mL/s 2  × 10 -3  (-0.3;0.6)), E/A (-0.09 (-0.23;0.05)), E/Ea (+0.1 (-1.2;1.3)) and ejection fraction (0% (-3;2)), but decreased stroke volume (-9 mL (-14;-5)) and increased heart rate (+10 bpm (4;15)). Aortic PWV (+0.5 m/s (-0.6;1.6)), myocardial triglyceride content (+0.21% (-0.09;0.51)), and ECV (-0.2% (-1.4;1.0)) were unaltered.
DATA CONCLUSION


Liraglutide did not affect LV diastolic and systolic function, aortic stiffness, myocardial triglyceride content, or extracellular volume in Dutch South Asian type 2 diabetes patients with or without coronary artery disease.
LEVEL OF EVIDENCE


1 Technical Efficacy Stage: 4 J. Magn. Reson. Imaging 2020;51:1679-1688.",2020,"Liraglutide did not affect LV diastolic and systolic function, aortic stiffness, myocardial triglyceride content, or extracellular volume in Dutch South Asian type 2 diabetes patients with or without coronary artery disease.
","['South Asian type 2 diabetes patients', 'Forty-seven type 2 diabetes patients of South Asian ancestry living in the Netherlands, with or without ischemic heart disease', 'Type 2 Diabetes Patients of South Asian Descent Living in the Netherlands', 'Dutch South Asian type 2 diabetes patients with or without coronary artery disease']","['Placebo', 'glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide', 'Liraglutide', 'placebo', 'liraglutide']","['myocardial triglyceride content', 'left ventricular (LV) diastolic and systolic function', 'stroke volume', 'changes in LV diastolic function (early deceleration peak [Edec], ratio of early and late peak filling rate [E/A], estimated LV filling pressure [E/Ea]) and LV systolic function (ejection fraction', 'Aortic PWV', 'ejection fraction', 'Cardiovascular Function and Myocardial Tissue Characteristics', 'LV diastolic and systolic function, aortic stiffness, myocardial triglyceride content, or extracellular volume', 'heart rate', 'changes in aortic stiffness (aortic pulse wave velocity [PWV]), myocardial steatosis (myocardial triglyceride content), and diffuse fibrosis (extracellular volume [ECV']","[{'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C4543206', 'cui_str': 'Receptor agonist (disposition)'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0429481', 'cui_str': 'Early fetal heart deceleration (finding)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}, {'cui': 'C0027061', 'cui_str': 'Muscle, Cardiac'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}, {'cui': 'C0521119', 'cui_str': 'Extracellular (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration (morphologic abnormality)'}, {'cui': 'C1265984', 'cui_str': 'Diffuse fibrosis'}]",47.0,0.355122,"Liraglutide did not affect LV diastolic and systolic function, aortic stiffness, myocardial triglyceride content, or extracellular volume in Dutch South Asian type 2 diabetes patients with or without coronary artery disease.
","[{'ForeName': 'Elisabeth H M', 'Initials': 'EHM', 'LastName': 'Paiman', 'Affiliation': 'Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Huub J', 'Initials': 'HJ', 'LastName': 'van Eyk', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Minke M A', 'Initials': 'MMA', 'LastName': 'van Aalst', 'Affiliation': 'Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Maurice B', 'Initials': 'MB', 'LastName': 'Bizino', 'Affiliation': 'Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Rob J', 'Initials': 'RJ', 'LastName': 'van der Geest', 'Affiliation': 'Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Jos J M', 'Initials': 'JJM', 'LastName': 'Westenberg', 'Affiliation': 'Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Petronella H', 'Initials': 'PH', 'LastName': 'Geelhoed-Duijvestijn', 'Affiliation': 'Department of Medicine, Haaglanden Medical Centre, The Hague, the Netherlands.'}, {'ForeName': 'Aan V', 'Initials': 'AV', 'LastName': 'Kharagjitsingh', 'Affiliation': 'Department of Diabetology and Endocrinology, University Hospital Brussels, Brussels, Belgium.'}, {'ForeName': 'Patrick C N', 'Initials': 'PCN', 'LastName': 'Rensen', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Johannes W A', 'Initials': 'JWA', 'LastName': 'Smit', 'Affiliation': 'Department of Medicine, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Ingrid M', 'Initials': 'IM', 'LastName': 'Jazet', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Hildo J', 'Initials': 'HJ', 'LastName': 'Lamb', 'Affiliation': 'Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.27009']
2066,31314954,The effect of intradermal microdosing of a transient receptor potential cation channel subfamily V member 1 antagonist on heat evoked pain and thermal thresholds in normal and ultraviolet-C exposed skin in healthy volunteers.,"BACKGROUND


Three TRPV1 (Transient Receptor Potential Vanilloid Receptor 1) antagonists were developed for testing in situ in human skin (Sjögren et al., 2016; Sjögren et al., 2018; Sjögren et al., 2018). The first human study using these compounds and capsaicin, was performed to determine the required local antagonist concentrations needed for target engagement (Proof of Mechanism, PoM) (Sjögren et al., 2018). In this paper, the aim was to address a TRPV1 antagonist's ability to inhibit a more complex pain signal and to define translational endpoints that could be used in further drug development, when progressing orally bioavailable TRPV1 antagonists as novel analgesic medications.
METHOD


This was a single centre, placebo-controlled, clinical proof of principle (PoP) study in 25 healthy volunteers. The subjects were exposed to UV irradiation, causing a local tissue inflammation. Three different doses of AZ12048189 were administered to assess pain perception through quantitative sensory testing (QST) and erythema using Laser Doppler scanning.
RESULTS


AZ12048189 increased the warmth detection threshold (WDT) and the heat pain threshold (HPT) and decreased the intensity of supra threshold heat pain (STHP). AZ12048189 did not, however, have any significant effects as assessed using mechanical stimulation or Laser Doppler.
CONCLUSIONS


This study validated translational tools to confirm target engagement for TRPV1 antagonists; WDT, HPT and STHP have utility in this respect, after oral administration of a TRPV1 antagonist. This study also proved that TRPV1 antagonists can inhibit a more complex, non-capsaicin dependent thermally induced pain signal.",2019,"RESULTS


AZ12048189 increased the warmth detection threshold (WDT) and the heat pain threshold (HPT) and decreased the intensity of supra threshold heat pain (STHP).","['25 healthy volunteers', 'healthy volunteers']","['capsaicin', 'transient receptor potential cation channel subfamily V member 1 antagonist', 'TRPV1']","['intensity of supra threshold heat pain (STHP', 'mechanical stimulation or Laser Doppler', 'warmth detection threshold (WDT) and the heat pain threshold (HPT', 'pain perception through quantitative sensory testing (QST) and erythema']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C1563722', 'cui_str': 'Transient Receptor Potential Channels'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1285354', 'cui_str': 'Mechanical stimulation'}, {'cui': 'C0430489', 'cui_str': 'Laser doppler (procedure)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0200116', 'cui_str': 'Sensory testing'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}]",25.0,0.0277686,"RESULTS


AZ12048189 increased the warmth detection threshold (WDT) and the heat pain threshold (HPT) and decreased the intensity of supra threshold heat pain (STHP).","[{'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Sjögren', 'Affiliation': 'Department of Pharmacy, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Ståhle', 'Affiliation': 'CLINTEC, Karolinska University Hospital Huddinge, Karolinska Institute, Solna, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Quiding', 'Affiliation': '3diva, Växjö, Sweden.'}, {'ForeName': 'Bror', 'Initials': 'B', 'LastName': 'Jonzon', 'Affiliation': 'Medical Products Agency, Uppsala, Sweden.'}, {'ForeName': 'Magnus M', 'Initials': 'MM', 'LastName': 'Halldin', 'Affiliation': 'AlzeCure Foundation, Karolinska Institute Science Park, Huddinge, Sweden.'}, {'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Sundgren', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland, USA.'}]","European journal of pain (London, England)",['10.1002/ejp.1451']
2067,29628182,[Group intervention from a sensorimotor approach to reduce the intensity of chronic pain].,"OBJECTIVE


To assess the effectiveness, on people with chronic pain, of an intervention (Time In) designed to reduce pain and to improve psychological symptoms.
DESIGN


A randomized clinical trial with a control group, taking three measurements over three months.
SETTING


Granada, Spain.
PARTICIPANTS


A sample of 40 women aged 18 or older with a history (over 6 months) of chronic pain. The recruitment was in the Fibromyalgia Association of Granada, Spain (AGRAFIM).
INTERVENTIONS


Time In is a sensorimotor intervention that combines biomechanical physiotherapeutic procedures and psychological strategies. A weekly session of 3h was planned and the total of the program was developed during five weeks.
MAIN MEASUREMENTS


Independent variables: sociodemographic information, clinical history and Time In intervention. Dependent variables: Brief Pain Inventory (BPI-S), Short-Form Health Survey (SF-12), Symptom Check List-90-R (SCL-90-R) and Clinical Outcome in Routine Evaluation (CORE-OM).
RESULTS


Significant differences were observed between control group and intervention group of most of the scales used in postintervention and follow up measurements. Thus, significantly lower mean scores were obtained in intensity, interference and areas of pain, quality of life, psychological symptoms and behavioural change. Similar results were observed on d Cohen scores. They were 'very important' on intensity of pain (d=-1.01, d=-0.97) and interference of pain (d=-0.85, d=-0.74), with an improvement percentage from 21% to 30%.
CONCLUSIONS


Time In intervention reduces pain and improves psychological symptoms in patients with fibromyalgia; this results in a better quality of life.",2019,"RESULTS


Significant differences were observed between control group and intervention group of most of the scales used in postintervention and follow up measurements.","['A sample of 40 women aged 18 or older with a history (over 6 months) of chronic pain', 'patients with fibromyalgia', 'people with chronic pain', 'Granada, Spain']",['sensorimotor approach'],"['intensity of pain', 'Pain Inventory (BPI-S), Short-Form Health Survey (SF-12), Symptom Check List-90-R (SCL-90-R) and Clinical Outcome in Routine Evaluation (CORE-OM', 'intensity, interference and areas of pain, quality of life, psychological symptoms and behavioural change', 'pain', 'intensity of chronic pain', 'interference of pain', 'sociodemographic information, clinical history and Time', 'psychological symptoms']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",40.0,0.163946,"RESULTS


Significant differences were observed between control group and intervention group of most of the scales used in postintervention and follow up measurements.","[{'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Cantero-Braojos', 'Affiliation': 'MenSana, Psicología y Salud, Granada, España.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Cabrera-León', 'Affiliation': 'Escuela Andaluza de Salud Pública, Instituto de Investigación Biosanitaria ibs.GRANADA, Hospitales Universitarios de Granada/Universidad de Granada, Granada, España; Centro de Investigación Biomédica en Red de Salud Pública y Epidemiología (CIBERESP), Madrid, España. Electronic address: acabreraleon@gmail.com.'}, {'ForeName': 'María Angeles', 'Initials': 'MA', 'LastName': 'López-González', 'Affiliation': 'Departamento de Personalidad, Evaluación y Tratamientos Psicológicos, Facultad de Psicología, UNED, Madrid, España.'}, {'ForeName': 'Luís Angel', 'Initials': 'LA', 'LastName': 'Saúl', 'Affiliation': 'Departamento de Personalidad, Evaluación y Tratamientos Psicológicos, Facultad de Psicología, UNED, Madrid, España.'}]",Atencion primaria,['10.1016/j.aprim.2017.07.006']
2068,30968546,Exercise testing after chronic total coronary occlusion revascularization in patients with STEMI and a concurrent CTO: A subanalysis of the EXPLORE-trial.,"OBJECTIVES


To assess the effect of chronic total occlusion percutaneous coronary intervention (CTO PCI) on ventricular ectopy (VE) and symptomatology during exercise testing.
BACKGROUND


During exercise, the hypoxic myocardium in the CTO-territory can act as a substrate for VE and could lead to anginal complaints.
METHODS


In the EXPLORE-trial, 302 ST-segment elevation myocardial infarction (STEMI)-patients were randomized to CTO PCI or no-CTO PCI. For this sub-study, we analyzed all available exercise electrocardiograms (X-ECGs) at 4 months follow-up on symptoms and electrocardiographic parameters.
RESULTS


A total of 155 X-ECGs were available, 80 in the CTO PCI group (51.6%) and 75 in the no-CTO PCI group (48.4%). There were no differences regarding exercised time, achieved endurance, ST-deviation nor maximum heart-rate. The percentage of patients experiencing chest-pain during exercise was lower in the CTO PCI group (0% vs. 8.5%, p = .03). Also, there was a trend towards a higher maximum systolic blood pressure (SBP, 185 mmHg vs. 175, p = .09). No difference in VE was found between randomization groups, but patients with successful CTO PCI had a higher frequency of VE, compared to failed and no-CTO PCI (26% vs. 8%, p = .02). This did not result in higher frequencies of sustained ventricular arrhythmias or mortality.
CONCLUSION


In conclusion, in STEMI-patients, CTO PCI is associated with a small reduction of chest-pain during exercise and tended to be associated with an increase of maximum SBP. The observation that successful CTO PCI was associated with more VE during exercise, compared with failed/no-CTO PCI needs further exploration.",2019,"No difference in VE was found between randomization groups, but patients with successful CTO PCI had a higher frequency of VE, compared to failed and no-CTO PCI (26% vs. 8%, p = .02).","['patients with STEMI and a concurrent CTO', '302 ST-segment elevation myocardial infarction (STEMI)-patients']","['Exercise testing', 'CTO PCI or no-CTO PCI', 'CTO PCI', 'chronic total occlusion percutaneous coronary intervention (CTO PCI']","['VE', 'percentage of patients experiencing chest-pain during exercise', 'maximum SBP', 'ventricular ectopy (VE) and symptomatology', 'exercised time, achieved endurance, ST-deviation nor maximum heart-rate', 'maximum systolic blood pressure', 'higher frequencies of sustained ventricular arrhythmias or mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0439587', 'cui_str': 'Exercise time (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C1282150', 'cui_str': 'Maximum systolic blood pressure'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",302.0,0.0926531,"No difference in VE was found between randomization groups, but patients with successful CTO PCI had a higher frequency of VE, compared to failed and no-CTO PCI (26% vs. 8%, p = .02).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'van Veelen', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Heart Center, The Netherlands.'}, {'ForeName': 'Ivo M', 'Initials': 'IM', 'LastName': 'van Dongen', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Heart Center, The Netherlands.'}, {'ForeName': 'Joëlle', 'Initials': 'J', 'LastName': 'Elias', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Heart Center, The Netherlands.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Råmunddal', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Erlend', 'Initials': 'E', 'LastName': 'Eriksen', 'Affiliation': 'Department of Cardiology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'René J', 'Initials': 'RJ', 'LastName': 'van der Schaaf', 'Affiliation': 'Department of Cardiology, OLVG Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Bimmer E P M', 'Initials': 'BEPM', 'LastName': 'Claessen', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Heart Center, The Netherlands.'}, {'ForeName': 'Pieter G', 'Initials': 'PG', 'LastName': 'Postema', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Heart Center, The Netherlands.'}, {'ForeName': 'José P S', 'Initials': 'JPS', 'LastName': 'Henriques', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Heart Center, The Netherlands.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28282']
2069,31971679,Teprotumumab for the Treatment of Active Thyroid Eye Disease.,"BACKGROUND


Thyroid eye disease is a debilitating, disfiguring, and potentially blinding periocular condition for which no Food and Drug Administration-approved medical therapy is available. Strong evidence has implicated the insulin-like growth factor I receptor (IGF-IR) in the pathogenesis of this disease.
METHODS


In a randomized, double-masked, placebo-controlled, phase 3 multicenter trial, we assigned patients with active thyroid eye disease in a 1:1 ratio to receive intravenous infusions of the IGF-IR inhibitor teprotumumab (10 mg per kilogram of body weight for the first infusion and 20 mg per kilogram for subsequent infusions) or placebo once every 3 weeks for 21 weeks; the last trial visit for this analysis was at week 24. The primary outcome was a proptosis response (a reduction in proptosis of ≥2 mm) at week 24. Prespecified secondary outcomes at week 24 were an overall response (a reduction of ≥2 points in the Clinical Activity Score plus a reduction in proptosis of ≥2 mm), a Clinical Activity Score of 0 or 1 (indicating no or minimal inflammation), the mean change in proptosis across trial visits (from baseline through week 24), a diplopia response (a reduction in diplopia of ≥1 grade), and the mean change in overall score on the Graves' ophthalmopathy-specific quality-of-life (GO-QOL) questionnaire across trial visits (from baseline through week 24; a mean change of ≥6 points is considered clinically meaningful).
RESULTS


A total of 41 patients were assigned to the teprotumumab group and 42 to the placebo group. At week 24, the percentage of patients with a proptosis response was higher with teprotumumab than with placebo (83% [34 patients] vs. 10% [4 patients], P<0.001), with a number needed to treat of 1.36. All secondary outcomes were significantly better with teprotumumab than with placebo, including overall response (78% of patients [32] vs. 7% [3]), Clinical Activity Score of 0 or 1 (59% [24] vs. 21% [9]), the mean change in proptosis (-2.82 mm vs. -0.54 mm), diplopia response (68% [19 of 28] vs. 29% [8 of 28]), and the mean change in GO-QOL overall score (13.79 points vs. 4.43 points) (P≤0.001 for all). Reductions in extraocular muscle, orbital fat volume, or both were observed in 6 patients in the teprotumumab group who underwent orbital imaging. Most adverse events were mild or moderate in severity; two serious events occurred in the teprotumumab group, of which one (an infusion reaction) led to treatment discontinuation.
CONCLUSIONS


Among patients with active thyroid eye disease, teprotumumab resulted in better outcomes with respect to proptosis, Clinical Activity Score, diplopia, and quality of life than placebo; serious adverse events were uncommon. (Funded by Horizon Therapeutics; OPTIC ClinicalTrials.gov number, NCT03298867, and EudraCT number, 2017-002763-18.).",2020,"At week 24, the percentage of patients with a proptosis response was higher with teprotumumab than with placebo (83% [34 patients] vs. 10% [4 patients], P<0.001), with a number needed to treat of 1.36.","['patients with active thyroid eye disease', 'patients with active thyroid eye disease in a 1:1 ratio to receive intravenous infusions of the', 'Active Thyroid Eye Disease', '41 patients']","['placebo', 'Teprotumumab', 'IGF-IR inhibitor teprotumumab']","['mean change in GO-QOL overall score', 'overall response (a reduction of ≥2 points in the Clinical Activity Score plus a reduction in proptosis of ≥2 mm), a Clinical Activity Score of 0 or 1 (indicating no or minimal inflammation), the mean change in proptosis across trial visits', 'extraocular muscle, orbital fat volume', 'proptosis, Clinical Activity Score, diplopia, and quality of life', 'proptosis response (a reduction in proptosis of ≥2 mm', 'mean change in proptosis', 'Clinical Activity Score', 'overall response', 'diplopia response', ""mean change in overall score on the Graves' ophthalmopathy-specific quality-of-life (GO-QOL) questionnaire across trial visits"", 'proptosis response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0339143', 'cui_str': 'Graves Ophthalmopathy'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2987429', 'cui_str': 'teprotumumab'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015300', 'cui_str': 'Proptosis'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0028863', 'cui_str': 'Extraocular Muscles'}, {'cui': 'C1285517', 'cui_str': 'Orbital fat'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0012569', 'cui_str': 'Double Vision'}, {'cui': 'C0034380'}, {'cui': 'C0339143', 'cui_str': 'Graves Ophthalmopathy'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",41.0,0.486477,"At week 24, the percentage of patients with a proptosis response was higher with teprotumumab than with placebo (83% [34 patients] vs. 10% [4 patients], P<0.001), with a number needed to treat of 1.36.","[{'ForeName': 'Raymond S', 'Initials': 'RS', 'LastName': 'Douglas', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Kahaly', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Saba', 'Initials': 'S', 'LastName': 'Sile', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Elizabeth H Z', 'Initials': 'EHZ', 'LastName': 'Thompson', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Perdok', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Fleming', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Fowler', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Marcocci', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Marinò', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Antonelli', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Dailey', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Harris', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Eckstein', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Schiffman', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Tang', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Nelson', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Salvi', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wester', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Jeffrey W', 'Initials': 'JW', 'LastName': 'Sherman', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Vescio', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Holt', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Terry J', 'Initials': 'TJ', 'LastName': 'Smith', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}]",The New England journal of medicine,['10.1056/NEJMoa1910434']